20-F

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 20-F

(Mark One)

☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934

OR

☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended June 30, 2021

OR

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

OR

☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Date of event requiring this shell company report                     

For the transition period from                      to                     

Commission file number 0-29962

Kazia Therapeutics Limited

ACN 063 259 754

(Exact name of Registrant as specified in its charter)

Not Applicable

(Translation of Registrant’s name into English)

New South Wales, Australia

(Jurisdiction of incorporation or organization)

Three International Towers Level 24, 300 Barangaroo Avenue, Sydney, New South Wales 2000, Australia

(Address of principal executive offices)

Gabrielle Heaton

(e)Gabrielle.Heaton@kaziatherapeutics.com (t) +61-2-9472-4101

Three International Towers Level 24, 300 Barangaroo Avenue, Sydney, New South Wales 2000, Australia

(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)

Securities registered or to be registered pursuant to Section 12(b) of the Act.

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
American Depositary Shares, each representing ten Ordinary Shares*	KZIA	The NASDAQ Stock Market

Securities registered or to be registered pursuant to Section 12(g) of the Act.

None

* Not for trading, but only in connection with the registration of American Depositary Shares.

Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act.

Not Applicable

Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report.

The number of outstanding Ordinary Shares of the issuer as at June 30, 2021, was 132,012,209.

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.

Yes  ☐            No  ☒

If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.

Yes  ☐            No  ☒

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes  ☒            No  ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

Yes  ☒            No  ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See definition of “large accelerated filer”, “accelerated filer”, and “emerging growth company” in Rule 12b-2 of the Exchange Act:

Large accelerated filer  ☐                Accelerated filer  ☐                Non-accelerated filer  ☒                Emerging growth company  ☐

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.  ☐

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:

U.S. GAAP  ☐ International Financial Reporting Standards as issued by the International Accounting Standards Board  ☒ Other  ☐

If ‘Other’ has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.

Item 17  ☐        Item 18  ☐

If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes  ☐            No  ☒

TABLE OF CONTENTS

FORWARD-LOOKING STATEMENTS		1
PART I		1
Item 1.	Identity of Directors, Senior Management and Advisors	1
Item 2.	Offer Statistics and Expected Timetable	1
Item 3.	Key Information	1
Item 4.	Information on the Company	11
Item 4A.	Unresolved Staff Comments	21
Item 5.	Operating and Financial Review and Prospects	21
Item 6.	Directors, Senior Management and Employees	25
Item 7.	Major Shareholders and Related Party Transactions	34
Item 8.	Financial Information	35
Item 9.	The Offer and Listing	35
Item 10.	Additional Information	35
Item 11.	Quantitative and Qualitative Disclosures about Market Risk	46
Item 12.	Description of Securities Other than Equity Securities	47
PART II		48
Item 13.	Defaults, Dividend Arrearages and Delinquencies	48
Item 14.	Material Modifications to the Rights of Security Holders and the Use of Proceeds	48
Item 15.	Controls and Procedures	48
Item 16.	[Reserved]	48
Item 16A.	Audit Committee Financial Expert	48
Item 16B.	Code of Ethics	49
Item 16C.	Principal Accounting Fees and Services	49
Item 16D.	Exemptions from the Listing Standards for Audit Committees	49
Item 16E.	Purchases of Equity Securities by the Issuer and Affiliated Purchasers	49
Item 16F.	Changes in registrant’s Certifying Accountant	49
Item 16G.	Corporate Governance	50
Item 16H.	Mine Safety Disclosure	51
PART III		51
Item 17.	Financial Statements	51
Item 18.	Financial Statements	51
Item 19.	Exhibits	51

FORWARD-LOOKING STATEMENTS

This Annual Report on Form 20-F includes forward-looking statements, which involve a number of risks and uncertainties. These forward-looking statements can generally be identified as such because the context of the statement will include words such as “may,” “will,” “intend,” “plan,” “believe,” “anticipate,” “expect,” “estimate,” “predict,” “potential,” “continue,” “likely,” or “opportunity,” the negative of these words or other similar words. Similarly, statements that describe our future plans, strategies, intentions, expectations, objectives, goals or prospects and other statements that are not historical facts are also forward-looking statements. Discussions containing these forward-looking statements may be found, among other places, in “Business Overview” and “Operating and Financial Review and Prospects” in this Annual Report on Form 20-F. For such statements, we claim the protection of the Private Securities Litigation Reform Act of 1995 and section 27A of the Securities Act and Section 21E of the Exchange Act. Readers of this Annual Report on Form 20-F are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the time this Annual Report on Form 20-F was filed with the Securities and Exchange Commission, or SEC. These forward-looking statements are based largely on our expectations and projections about future events and future trends affecting our business and are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements. These risks and uncertainties include, without limitation, those discussed in “Risk Factors” and in “Operating and Financial Review and Prospects” of this Annual Report on Form 20-F. In addition, past financial or operating performance is not necessarily a reliable indicator of future performance, and you should not use our historical performance to anticipate results or future period trends. We can give no assurances that any of the events anticipated by the forward-looking statements will occur or, if any of them do, what impact they will have on our results of operations and financial condition. Except as required by law, we undertake no obligation to update publicly or revise our forward-looking statements to reflect events or circumstances that arise after the filing of this Annual Report on Form 20-F.

In this Annual Report on Form 20-F, “Kazia,” “Company,” “we,” “us” and “our” refer to Kazia Therapeutics Limited and its wholly owned subsidiaries on a consolidated basis, unless the context otherwise provides.

PART I

Item 1. Identity of Directors, Senior Management and Advisors

Item 1 details are not required to be disclosed as part of the Annual Report.

Item 2. Offer Statistics and Expected Timetable

Item 2 details are not required to be disclosed as part of the Annual Report.

Item 3. Key Information

A. Selected financial data

[Reserved]

B. Capitalization and Indebtedness.

Not applicable.

C. Reasons for the Offer and Use of Proceeds.

Not applicable.

D. Risk factors

Investment in our securities involves a high degree of risk. You should consider carefully the risks described below, together with other information in this Annual Report on Form 20-F and our other public filings, before making investment decisions regarding our securities. If any of the following events actually occur, our business, operating results, prospects or financial condition could be materially and adversely affected. This could cause the trading price of our common stock to decline and you may lose all or part of your investment. Moreover, the risks described below are not the only ones that we face. Additional risks not presently known to us or that we currently deem immaterial may also affect our business, operating results, prospects or financial condition.

1

Risks Related to Our Financial Condition and Capital Requirement

We have incurred significant net losses. We anticipate that we will continue to incur significant net losses for the foreseeable future and we may never achieve or maintain profitability.

We are a biotechnology company and have not yet generated significant revenue. We have incurred losses of A$10.3 million, A$12.5 million and A$8.4 million for the fiscal years ended June 30, 2019, 2020 and 2021, respectively. We have not generated any revenues from sales of any of our product candidates in prior financial years, however in the fiscal year ended June 30, 2021 we did generate revenues of A$15.2 million from the licensing of our drug products.

As of June 30, 2021, we had accumulated losses of A$44.2 million. We have devoted most of our financial resources to research and development, including our clinical development activities. To date, we have financed our operations primarily through the issuance of equity securities, research and development grants from the Australian government and payments from our collaboration partners. While we have generated significant revenue this fiscal year from license transactions, the nature of such revenue is irregular and unpredictable, and is based upon achievement of milestones over which we have limited or no control. As a consequence, we expect to continue to incur significant operating losses for the foreseeable future due to the cost of research and development including clinical trials and the regulatory approval process for product candidates. The amount of our future net losses is uncertain and will depend, in part, on the rate of our future expenditures. Our ability to continue operations will depend on, among other things, our ability to obtain funding through equity or debt financings, strategic collaborations or grants.

We expect to continue to incur significant expenses and similar or increasing operating losses for the foreseeable future. We anticipate that our expenses will increase substantially if and as we:

• continue our research and clinical development of our product candidates;

• expand the scope of our current clinical studies for our product candidates or initiate additional clinical or other studies for product candidates;

• seek regulatory and marketing approvals for any of our product candidates that successfully complete clinical trials;

• further develop the manufacturing process for our product candidates;

• change or add additional manufacturers or suppliers;

• seek to identify and validate additional product candidates;

• acquire or in-license other product candidates and technologies;

• maintain, protect and expand our intellectual property portfolio;

• create additional infrastructure to support our operations as a public company in the United States and our product development and future commercialization efforts; and

• experience any delays or encounter issues with any of the above.

The net losses we incur may fluctuate significantly from year to year, such that a period to-period comparison of our results of operations may not be a good indication of our future performance.

We have never generated any revenue from product sales and may never be profitable.

Our ability to generate significant revenue and achieve profitability depends on our ability, alone or with strategic collaboration partners, to successfully complete the development of and obtain the regulatory approvals for our product candidates, to manufacture sufficient supply of our product candidates, to establish a sales and marketing organization or suitable third-party alternative for the marketing of any approved products and to successfully commercialize any approved products on commercially reasonable terms. All of these activities will require us to raise sufficient funds to finance business activities. In addition, we do not anticipate generating revenue from commercializing product candidates for the foreseeable future, if ever. Our ability to generate future revenues from commercializing product candidates depends heavily on our success in:

• successfully initiating and completing clinical trials of our product candidates;

• obtaining regulatory and marketing approvals for product candidates for which we complete clinical trials;

• maintaining, protecting and expanding our intellectual property portfolio, and avoiding infringing on intellectual property of third parties;

• establishing and maintaining successful licenses, collaborations and alliances with third parties;

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• developing a sustainable, scalable, reproducible and transferable manufacturing process for our product candidates;

• establishing and maintaining supply and manufacturing relationships with third parties that can provide products and services adequate, in amount and quality, to support clinical development and commercialization of our product candidates, if approved;

• launching and commercializing any product candidates for which we obtain regulatory and marketing approval, either by collaborating with a partner or, if launched independently, by establishing a sales, marketing and distribution infrastructure;

• obtaining market acceptance of any product candidates that receive regulatory approval as viable treatment options;

• obtaining favorable coverage and reimbursement rates for our products from third-party payers;

• addressing any competing technological and market developments;

• identifying and validating new product candidates; and

• negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter.

Even if one or more of our product candidates is approved for commercial sale, we may incur significant costs associated with commercializing any approved product candidate. As one example, our expenses could increase beyond expectations if we are required by the Food and Drug Administration, or FDA, or other regulatory agencies, domestic or foreign, to perform clinical and other studies in addition to those that we currently anticipate. Even if we are able to generate revenues from the sale of any approved products, we may not become profitable and may need to obtain additional funding to continue operations, which could have an adverse effect on our business, financial condition, results of operations and prospects.

The Company is currently conducting clinical trials of two experimental therapies. Failure of one or both of these therapies to show benefit to patients could materially affect the continuity of our business and our financial condition.

The Company’s lead programs include paxalisib (formerly GDC-0084), a small molecule inhibitor of the PI3K/Akt/mTor pathway, and EVT801, a small-molecule selective inhibitor of vascular endothelial growth factor receptor 3 (VEGFR3). However, even though progress has been made, such as the clinical validation of the PI3K/Akt/mTor pathway as a target for oncology therapies, developments of our product candidates may prove unsuccessful, after completion of clinical trials, due to any failure to provide any beneficial effect to cancer patients. It is possible that either or both agents may fail to show sufficient benefit as a treatment for cancer to become commercially viable products.

The Company has ongoing clinical trials in which experimental therapies are administered to human subjects. If profound and unexpected safety concerns are encountered in clinical trials, it may materially affect the continuity of our business and our financial condition.

Despite all applicable efforts to characterise the safety profile of our drug development candidates through animal studies and other mechanisms, the possibility of unexpected safety concerns remains. If one or both of our clinical stage candidates were found to be associated with profound and unexpected toxicity, Kazia may be required to cease development, and may additionally incur other impairments to the business including reputational damage.

The Company’s ability to continue as a going concern is dependent on its ability to raise capital to support its R&D programs.

The Company has limited cash resources and will periodically need additional funds to maintain the planned level of R&D activity. We expect to consume cash and incur operating losses for the foreseeable future as the Company continues developing its oncology drug candidates. The impact on cash resources and results from operations will vary with the extent and timing of future clinical trial programs. While it is not possible to make accurate predictions of future operating results, we expect existing cash and cash equivalents will be sufficient to enable us to continue our research and development activities until approximately the final quarter of calendar 2022.

As at June 30, 2021, we had cash in hand and at bank of A$27.6 million. The financial statements have been prepared on a going concern basis, which contemplates continuity of normal activities and realisation of assets and settlement of liabilities in the normal course of business. As is often the case with drug development companies, our ability to continue as a going concern is dependent upon our ability to derive sufficient cash from investors, from licensing and partnering activities and from other sources of revenue such as grant funding. The directors have considered the cash flow forecasts and the funding requirements of the business and are confident that the strategies in place are appropriate to generate sufficient funding to allow us to continue as a going concern.

3

If the Company is unable to obtain additional funds on favorable terms or at all, it may be required to cease or reduce its operations. Also, if the Company raises more funds by selling additional securities, the ownership interests of holders of its securities will be diluted.

Negative global economic conditions may pose challenges to the Company’s business strategy, which relies on access to capital from the markets or collaborators. Failure to obtain sufficient funding on acceptable terms could have a material adverse effect on our business, results of operations and financial condition.

Negative conditions in the global economy, including credit markets and the financial services industry, have generally made equity and debt financing more difficult to obtain, and may negatively impact the Company’s ability to complete financing transactions. For instance, the current COVID-19 global pandemic has negatively affected the global economy and has created uncertainties in the financial markets and volatility in stock markets, which increases the risk of capital raisings being unsuccessful for issuers that need funds to finance their business operations. The duration and severity of these conditions is uncertain, as is the extent to which they may adversely affect the Company’s business and the business of current and prospective vendors and collaborators. If negative global economic conditions persist or worsen, the Company may be unable to secure additional funding to sustain its operations or to find suitable collaborators to advance its internal programs, even if positive results are achieved from research and development efforts.

If we are unable to raise sufficient funding on acceptable terms, we may be unable to continue to operate. There is no assurance that we will be successful in obtaining sufficient financing on acceptable terms and conditions to fund continuing operations, if at all. Our failure to obtain sufficient funds on acceptable terms when needed could have a material adverse effect on our business, results of operations and financial condition.

Risks Related to Our Business Operations

We may not successfully engage in strategic transactions or enter into new collaborations, which could adversely affect our ability to develop and commercialize product candidates, impact our cash position, increase our expenses and present significant distractions to our management.

From time to time, we may consider additional strategic transactions, such as collaborations, acquisitions, asset purchases or sales and out- or in-licensing of product candidates or technologies. In particular we will evaluate and, if strategically attractive, seek to enter into additional collaborations, including with major biotechnology or pharmaceutical companies. The competition for collaborators is significant, and the negotiation process is time-consuming and complex. Any new collaboration may be on terms that are not optimal for us, and we may not be able to maintain any new or existing collaboration if, for example, development or approval of a product candidate is delayed, sales of an approved product candidate do not meet expectations or the collaborator discontinues the collaboration. Any such collaboration, or other strategic transaction, may require us to incur non-recurring or other charges, increase our expenditures, pose significant integration or implementation challenges or disrupt our management or business.

These transactions would entail numerous operational and financial risks, including exposure to unknown liabilities, incurrence of substantial debt or dilutive issuances of equity securities to pay transaction consideration or costs, higher than expected collaboration, acquisition or integration costs, write-downs of assets or goodwill or impairment charges, increased amortization expenses, difficulty and cost in facilitating the collaboration or combining the operations and personnel of any acquired business, impairment of relationships with key suppliers, manufacturers or customers of any acquired business due to changes in management and ownership and the inability to retain key employees of any acquired business.

Accordingly, although there can be no assurance that we will undertake or successfully complete any additional transactions of the nature described above, any transactions that we do complete may be subject to the foregoing or other risks and have a material adverse effect on our business, results of operations, financial condition and prospects. Conversely, any failure to enter any collaboration or other strategic transaction that would be beneficial to us could delay and make more expensive the development and potential commercialization of our product candidates and have a negative impact on the competitiveness of any product candidate that reaches market.

Any inability to attract and retain qualified key management and technical personnel would impair our ability to implement our business plan.

Our success largely depends on the continued service of key management and other specialized personnel. The loss of one or more members of our management team or other key employees or advisors could delay or increase the cost of our research and development programs and materially harm our business, financial condition, results of operations and prospects. The relationships that our key managers have cultivated within our industry make us particularly dependent upon their continued employment with us. We are dependent on the continued service of our technical personnel because of the highly technical nature of our product candidates and the specialized nature of the regulatory approval process for our product candidates. Because our management team and key employees are not obligated to provide us with continued service, they could terminate their employment with us at any time without penalty. We do not maintain key person life insurance policies on any of our management team members or key employees. Our future success will depend in large part on our continued ability to attract and retain other highly qualified scientific, technical and management personnel, as well as personnel with expertise in clinical testing, manufacturing, governmental regulation and commercialization. We face competition for personnel from other companies, universities, public and private research institutions, government entities and other organizations.

4

Our collaborations with outside scientists and consultants may be subject to restriction and change.

We work with medical experts, chemists, biologists and other scientists at academic and other institutions, and consultants who assist us in our research, development and regulatory efforts, including the members of our scientific advisory board. In addition, these scientists and consultants have provided, and we expect that they will continue to provide, valuable advice regarding our programs and regulatory approval processes. These scientists and consultants are not our employees and may have other commitments that would limit their future availability to us. If a conflict of interest arises between their work for us and their work for another entity, we may lose their services. In addition, we are limited in our ability to prevent them from establishing competing businesses or developing competing products. For example, if a key scientist acting as a principal investigator in any of our future clinical trials identifies a potential product or compound that is more scientifically interesting to his or her professional interests, his or her availability to remain involved in any future clinical trials could be restricted or eliminated.

We face potential product liability, and, if successful claims are brought against us, we may incur substantial liability and costs. If the use of our product candidates harms patients, or is perceived to harm patients even when such harm is unrelated to our product candidates, our regulatory approvals could be revoked or otherwise negatively impacted and we could be subject to costly and damaging product liability claims.

The use of our product candidates in clinical trials and the sale of any products for which we may in the future obtain marketing approval exposes us to the risk of product liability claims. Product liability claims might be brought against us by consumers, healthcare providers, pharmaceutical companies or others selling or otherwise coming into contact with our product candidates. There is a risk that our product candidates may induce adverse events. If we cannot successfully defend against product liability claims, we could incur substantial liability and costs. In addition, regardless of merit or eventual outcome, product liability claims may result in:

• impairment of our business reputation;

• withdrawal of clinical trial participants;

• costs due to related litigation;

• distraction of management’s attention from our primary business;

• substantial monetary awards to patients or other claimants;

• the inability to commercialize our product candidates;

• decreased demand for our product candidates, if approved for commercial sale; and

• increased cost, or impairment of our ability, to obtain or maintain product liability insurance coverage.

We may use our limited financial and human resources to pursue a particular research program or product candidate and fail to capitalize on programs or product candidates that may be more profitable or for which there is a greater likelihood of success.

Because we have limited resources, we may forego or delay pursuit of opportunities with certain programs or product candidates or for indications that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on current and future research and development programs for product candidates may not yield any commercially viable products. If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through strategic collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate, or we may allocate internal resources to a product candidate in a therapeutic area in which it would have been more advantageous to enter into a collaboration arrangement.

Our internal computer and information technology systems, or those of our collaborators and other development partners, third-party Contract Research Organisations (CROs) or other contractors or consultants, may fail or suffer security breaches, which could result in a disruption of our product development programs.

Despite the implementation of security measures, our internal computer and information technology systems and those of our current and any future CROs and other contractors, consultants and collaborators are vulnerable to damage from computer viruses, cyber-attacks, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. Such events could cause interruptions of our operations. While we have not experienced any material system failure, accident or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a disruption of our development programs and our business operations, whether due to a loss of our trade secrets or other similar disruptions. For example, the loss of clinical trial data from ongoing or future clinical trials or data from preclinical studies could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. Likewise, we rely on third parties to manufacture our product candidates and will rely on third parties to conduct future clinical trials, and similar events relating to their computer systems could also have similar consequences to our business. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development and commercialization of our product candidates could be delayed and become more expensive.

5

Our ability to utilize our net operating losses and certain other tax attributes may be limited.

We have substantial carried forward tax losses which may not be available to offset any future assessable income. In order for an Australian corporate taxpayer to carry forward and utilize tax losses, the taxpayer must pass either the continuity of ownership test, or, if it fails the COT, the same business test (“SBT”), or similar business test, in respect of relevant tax losses.

We have not carried out any analysis as to whether we have met the COT or, failing the COT, the SBT or similar business test over relevant periods. In addition, future shareholding changes may result in a significant ownership change for us. It is therefore uncertain as to whether any of our tax losses carried forward as of June 30, 2021 will be available to be carried forward and available to offset our assessable income, if any, in future periods.

Risks Related to the Product Development and Regulatory Approval of Our Product Candidates

We may not be able to obtain orphan drug exclusivity, where relevant, in all markets for our product candidates.

Regulatory authorities in some jurisdictions, including the United States, may designate drugs for relatively small patient populations as orphan drugs. Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a product intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals annually in the United States. The FDA may also designate a product as an orphan drug if it is intended to treat a disease or condition of more than 200,000 individuals in the United States and there is no reasonable expectation that the cost of developing and making a drug or biological product available in the United States for this type of disease or condition will be recovered from sales of the product candidate.

Generally, if a product with an orphan drug designation subsequently receives the first marketing approval for the indication for which it has such designation, the product is entitled to a period of marketing exclusivity, which precludes the FDA from approving another marketing application for the same drug for such indication for that time period. The applicable period is seven years in the United States. Orphan drug exclusivity may be lost if the FDA determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the drug to meet the needs of patients with the rare disease or condition.

In February 2018, the FDA granted orphan drug designation status in the United States for paxalisib (formerly GDC-0084) for the treatment of glioblastoma, and in August 2020, the FDA granted orphan drug designation status in the United States for paxalisib (formerly GDC-0084) for the treatment of malignant glioma, which includes DIPG, a rare and highly aggressive childhood brain cancer. Even if we obtain orphan drug exclusivity for additional products in the United States or other jurisdictions, that exclusivity may not effectively protect the product from competition because different drugs can be approved for the same condition, and the same drug could be approved for a different condition. Moreover, even after an orphan drug is approved, the FDA can subsequently approve the same drug, made by a competitor, for the same condition if the FDA concludes that the competitive product is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care.

Positive results from preclinical studies of our product candidates are not necessarily predictive of the results of our planned clinical trials of our product candidates.

Positive results in preclinical proof of concept and animal studies of our product candidates may not result in positive results in clinical trials in humans. Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in clinical trials after achieving positive results in preclinical development or early stage clinical trials, and we cannot be certain that we will not face similar setbacks. These setbacks have been caused by, among other things, preclinical findings made while clinical trials were underway or safety or efficacy observations made in clinical trials, including adverse events. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that believed their product candidates performed satisfactorily in preclinical studies and clinical trials nonetheless failed to obtain FDA or other regulatory authority approval. If we fail to produce positive results in our clinical trials of our product candidates, the development timeline and regulatory approval and commercialization prospects for our product candidates, and, correspondingly, our business and financial prospects, would be negatively impacted.

Even if the Company receives regulatory approval to commercialize its drug candidates, the ability to generate revenues from any resulting products will be subject to a variety of risks, many of which are out of the Company’s control.

Regardless of regulatory approval, products arising from the development process may not gain market acceptance among physicians, patients, healthcare payers or the medical community. The Company believes that the degree of market acceptance and its ability to generate revenues from such products will depend on a number of factors, including, but not limited to:

• advancements in the treatment of cancer that make our treatments obsolete;

6

• market exclusivity and competitor products;

• timing of market introduction of the Company’s drugs and competitive drugs;

• actual and perceived efficacy and safety of the Company’s drug candidates;

• prevalence and severity of any side effects;

• potential or perceived advantages or disadvantages over alternative treatments;

• strength of sales, marketing and distribution support;

• price of future products, both in absolute terms and relative to alternative treatments;

• the effect of current and future healthcare laws on the Company’s drug candidates; and

• availability of coverage and reimbursement from government and other third-party payers.

If any of the Company’s drugs are approved and fail to achieve market acceptance, the Company may not be able to generate significant revenue to achieve or sustain profitability.

Risks Related to Commercialization of Our Product Candidates

The Company may not be able to establish the contractual arrangements necessary to develop, market and distribute the product candidates. Our failure to do so may adversely affect our business, results of operations and financial condition.

The Company has been successful in executing contractual agreements with strategic partners. This remains a key part of the Company’s business plan and the Company must continue to partner with third parties to manufacture clinical grade drug product and conduct key pre-clinical and clinical investigations. Strategic agreements around packaging, branding, market access and distribution for its drug products will also eventually be required.

However, potential partners could be discouraged by the Company’s limited operating history. There is no assurance that the Company will be able to negotiate commercially acceptable licensing or other agreements for the future exploitation of its drug product candidates including continued clinical development, manufacture or marketing. If the Company is unable to successfully contract for these services, or if arrangements for these services are terminated, the Company may have to delay the commercialization program which will adversely affect its ability to generate operating revenues.

The Company’s commercial opportunity will be reduced or eliminated if competitors develop and market products that are more effective, have fewer side effects or are less expensive than its drug candidates.

The development of drug candidates is highly competitive and is high risk. A number of other companies have products or drug candidates in various stages of pre-clinical or clinical development that are intended for the same therapeutic indications for which the Company’s drug candidates are being developed. Some of these potential competing drugs are further advanced in development than the Company’s drug candidates and may be commercialized sooner. Even if the Company is successful in developing effective drugs, its compounds may not compete successfully with products produced by its competitors.

The Company’s competitors include pharmaceutical companies and biotechnology companies, as well as universities and public and private research institutions. In addition, companies active in different but related fields represent substantial competition. Many of the Company’s competitors developing oncology drugs have significantly greater capital resources, larger R&D staff and facilities and greater experience in drug development, regulation, manufacturing and marketing. These organizations also compete with the Company and its service providers, to recruit qualified personnel, and to attract partners for joint ventures and to license technologies. As a result, the Company’s competitors may be able to develop technologies and products that would render the Company’s technologies or its drug candidates obsolete or non-competitive.

Risks Related to Our Intellectual Property

If we are unable to protect intellectual property rights related to our product candidates, we may not be able to obtain exclusivity for our product candidates or prevent others from developing similar competitive products.

We rely upon a combination of patents, know-how, trade secret protection and confidentiality agreements to protect the intellectual property related to our product candidates.

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The strength of patents in the biotechnology and pharmaceutical field involves complex legal and scientific questions and can be uncertain. The patent applications that we own or in-license may fail to result in issued patents with claims that cover our product candidates in the United States or other jurisdictions. In addition, we cannot guarantee that any patents will issue from any pending or future patent applications owned by or licensed to us. There is no assurance that all of the potentially relevant prior art relating to our patents and patent applications has been found. If such prior art exists, it can invalidate a patent or prevent a patent from issuing from a pending patent application. Even if patents do successfully issue and even if such patents cover our product candidates, third parties may initiate opposition, interference, re-examination, post-grant review, inter partes review, nullification or derivation action in court or before patent offices or similar proceedings challenging the validity, enforceability or scope of such patents, which may result in the patent claims being narrowed or invalidated. Furthermore, even if our patents and patent applications are unchallenged, they may not adequately protect our intellectual property, provide exclusivity for our product candidates or prevent others from designing around our claims. Any of these outcomes could impair our ability to prevent competition from third parties.

If the patent applications we hold or have in-licensed with respect to our programs or product candidates fail to issue, or are revoked, if the breadth or strength of our patent protection is threatened, or if our patent portfolio fails to provide meaningful exclusivity for our product candidates, it could dissuade companies from collaborating with us to develop product candidates and threaten our ability to commercialize future products. Any successful opposition to any patents owned by or licensed to us could deprive us of rights necessary for the successful commercialization of any product candidates that we may develop. Further, if we encounter delays in regulatory approvals, the period of time during which we could market a product candidate under patent protection could be reduced. Even where we have a valid and enforceable patent, we may not be able to exclude others from practicing our invention where the other party can show that they used the invention in commerce before our filing date or the other party benefits from a compulsory license. In addition, patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years after it is filed. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering our product candidates are obtained, once the patent life has expired for a product, we may be open to competition from competitive medications, including biosimilar or generic medications. This risk is material in light of the length of the development process of our products and lifespan of our current patent portfolio.

In addition to the protection afforded by patents, we rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable or that we elect not to patent, processes for which patents are difficult to enforce and any other elements of our product candidate discovery and development processes that involve proprietary know-how, information or technology that is not covered by patents. However, trade secrets can be difficult to protect. What constitutes a trade secret and what protections are available for trade secrets varies from state to state in the United States and country by country worldwide. We seek to protect our proprietary technology and processes, in part, by entering into confidentiality agreements with our employees, consultants, scientific advisors and contractors. We also seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and physical and electronic security of our information technology systems. Security measures may be breached, and we may not have adequate remedies for any breach. In addition, our trade secrets may otherwise become known or be independently discovered by competitors. Although we expect all of our employees and consultants to assign their inventions to us, and all of our employees, consultants, advisors and any third parties who have access to our proprietary know-how, information or technology to enter into confidentiality agreements, we cannot provide any assurances that all such agreements have been duly executed or that our trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques.

Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and applications are required to be paid to the USPTO and various governmental patent agencies outside of the United States in several stages over the lifetime of the patents and applications. The USPTO and various corresponding governmental patent agencies outside of the United States require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process and after a patent has issued. There are situations in which non-compliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.

Our success depends, in part, on our ability to protect our intellectual property and our technologies.

Our commercial success depends, in part, on our ability to obtain and maintain patent and trade secret protection for our technologies, our traits, and their uses, as well as our ability to operate without infringing upon the proprietary rights of others. If we do not adequately protect our intellectual property, competitors may be able to use our technologies and erode or negate any competitive advantage we may have, which could harm our business and ability to achieve profitability.

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Filing, prosecuting and defending patents on product candidates in all countries around the world would be prohibitively expensive. In addition, we may at times in-license third-party technologies for which limited international patent protection exists and for which the time period for filing international patent applications has passed. Consequently, we may not be able to prevent third parties from practicing our inventions, or from selling or importing products made using our inventions. Potential competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and further, may export otherwise infringing products to territories where we have patent protection but enforcement is difficult. These products may compete with our product candidates, if approved, and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights around the world. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property protection, particularly those relating to biotechnology products, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

Risks Related to Our Reliance on Third Parties

The Company relies on third parties to conduct its pre-clinical studies. If those parties do not successfully carry out their contractual duties or meet expected deadlines, the Company’s drug candidates may not advance in a timely manner or at all.

In the course of discovery, pre-clinical testing and clinical trials, the Company relies on third parties, including laboratories, investigators, clinical contract research organizations (“CROs”), and manufacturers, to perform critical services. For example, the Company relies on third parties to conduct all of its pre-clinical and clinical studies. These third parties may not be available when the Company needs them or, if they are available, may not comply with all regulatory and contractual requirements or may not otherwise perform their services in a timely or acceptable manner, and the Company may need to enter into new arrangements with alternative third parties and the studies may be extended, delayed or terminated. These independent third parties may also have relationships with other commercial entities, some of which may compete with the Company. As a result of the Company’s dependence on third parties, it may face delays or failures outside of its direct control. These risks also apply to the development activities of collaborators, and the Company does not control their research and development, clinical trial or regulatory activities.

The Company has no direct control over the cost of manufacturing its drug candidates. Increases in the cost of manufacturing the Company’s drug candidates would increase the costs of conducting clinical trials and could adversely affect future profitability.

The Company does not intend to manufacture the drug product candidates in-house, and it will rely on third parties for drug supplies both for clinical trials and for commercial quantities in the future. The Company has taken the strategic decision not to manufacture active pharmaceutical ingredients (“API”) for the drug candidates, as these can be more economically supplied by third parties with particular expertise in this area. The Company outsources the manufacture of its drug products and their testing to FDA requirements. The Company uses contract facilities that are registered with the FDA, have a track record of large-scale API manufacture, and have already invested in capital and equipment. The Company has no direct control over the cost of manufacturing its product candidates. If the cost of manufacturing increases, or if the cost of the materials used increases, these costs may be passed on, making the cost of conducting clinical trials more expensive. Increases in manufacturing costs could adversely affect the Company’s future profitability if it was unable to pass all of the increased costs along to its customers.

Risks Related to our Securities

Enforceability of civil liabilities under the federal securities laws against the Company or the Company’s officers and directors may be difficult.

The Company is a public company limited by shares and is registered and operates under the Australian Corporations Act 2001. Some of the Company’s directors and officers reside outside of the United States. In addition, a substantial portion of the directly owned assets of the Company are located outside of the United States. As a result, it may be difficult or impossible for investors to effect service of process within the United States against the Company or its directors and officers or to enforce against them any of the judgments, including those obtained in original actions or in actions to enforce judgments of the U.S. courts, predicated upon the civil liability provisions of the federal or state securities laws of the United States. There is doubt as to the enforceability in the Commonwealth of Australia, in original actions or in actions for enforcement of judgments of U.S. courts, of civil liabilities predicated solely upon federal or state securities laws of the U.S., especially in the case of enforcement of judgments of U.S. courts where the defendant has not been properly served in Australia.

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The trading price of the Company’s ordinary shares and American Depositary Shares (“ADSs”) is highly volatile. Your investment could decline in value and the Company may incur significant costs from class action litigations.

The trading price of the Company’s ordinary shares and ADSs is highly volatile in response to various factors, many of which are beyond the Company’s control, including:

• unacceptable toxicity findings in animals and humans;

• lack of efficacy in human trials at Phase II stage or beyond;

• announcements of technological innovations by the Company and its competitors;

• new products introduced or announced by the Company or its competitors;

• changes in financial estimates by securities analysts;

• actual or anticipated variations in operating results;

• expiration or termination of licenses, research contracts or other collaboration agreements;

• conditions or trends in the regulatory climate in the biotechnology, pharmaceutical and genomics industries;

• changes in the market values of similar companies;

• the liquidity of any market for the Company’s securities; and

• additional sales by the Company of its shares.

In addition, equity markets in general and the market for biotechnology and life sciences companies in particular, have experienced substantial price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of the companies traded in those markets. Further changes in economic conditions in Australia, the U.S., EU, or globally, could impact the Company’s ability to grow profitably. Adverse economic changes are outside the Company’s control and may result in material adverse effects on the Company’s business or results of operations. These broad market and industry factors may materially affect the market price of the Company’s ordinary shares and ADSs regardless of its development and operating performance. In the past, following periods of volatility in the market price of a company’s securities, securities class action litigation has often been instituted against that company. Such litigation, if instituted against the Company, could cause it to incur substantial costs and divert management’s attention and resources.

If the market price of the Company’s ADSs falls and remains below US$5.00 per share, under stock exchange rules, the Company’s stockholders will not be able to use such ADSs as collateral for borrowing in margin accounts. This inability to use ADSs as collateral may depress demand as certain institutional investors are restricted from investing in securities priced below US$5.00 and may lead to sales of such ADSs, creating downward pressure on and increased volatility in the market price of the Company’s ordinary shares and ADSs.

A decrease in the trading price of our ADSs could cause their delisting from NASDAQ.

Under NASDAQ rules, companies listed on the NASDAQ Capital Market are required to maintain a share price of at least US$1.00 per share to avoid delisting of their shares. If the share price declines below US$1.00 for a period of 30 consecutive business days, then that listed company would have 180 days to regain compliance with the US$1.00 per share minimum. In the event that the Company’s share price declines below US$1.00, it may be required to take action, such as a reverse stock split, in order to comply with the NASDAQ rules that may be in effect at the time.

You are reliant on the depositary to exercise your voting rights and to receive distributions on ADSs and, as a result, you may be unable to exercise your voting rights on a timely basis or you may not receive certain distributions.

In certain circumstances, holders of ADSs may have limited rights relative to holders of ordinary shares. The rights of holders of ADSs with respect to the voting of ordinary shares and the right to receive certain distributions may be limited in certain respects by the deposit agreement entered into by us and The Bank of New York Mellon. For example, although ADS holders are entitled under the deposit agreement, subject to any applicable provisions of Australian law and of our Constitution, to instruct the depositary as to the exercise of the voting rights pertaining to the ordinary shares represented by the ADSs, and the depositary has agreed that it will try, as far as practical, to vote the ordinary shares so represented in accordance with such instructions, ADS holders may not receive notices sent by the depositary in time to ensure that the depositary will vote the ordinary shares. This means that, from a practical point of view, the holders of ADSs may not be able to exercise their right to vote. In addition, under the deposit agreement, the depositary has the right to restrict distributions to holders of the ADSs in the event that it is unlawful or impractical to make such distributions. We have no obligation to take any action to permit distributions to holders of our ADSs. As a result, holders of ADSs may not receive distributions.

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There is a risk that we are, or will become, a passive foreign investment company, or PFIC, which will subject our U.S. investors to adverse tax rules

There is a risk that we are, or will become, a passive foreign investment company, commonly referred to as a PFIC. Our treatment as a PFIC could result in a reduction in the after-tax return to the U.S. holders of our ordinary shares or ADSs and would likely cause a reduction in the value of such ordinary shares or ADSs. For U.S. federal income tax purposes, we will be classified as a PFIC for any taxable year in which either (i) 75% or more of our gross income is passive income, or (ii) at least 50% of the average quarterly value of all of our assets for the taxable year produce or are held for the production of passive income. If we are classified as a PFIC for U.S. federal income tax purposes, highly complex rules will apply to U.S. holders owning ordinary shares or ADSs. Accordingly, you are urged to consult your tax advisors regarding the application of such rules. See Item 10 - Additional Information - Taxation, United States Federal Income Tax Consequences” for a more complete discussion of the U.S. federal income tax risks related to owning and disposing of our ordinary shares or ADSs.

Currency fluctuations may adversely affect the price of our ordinary shares, ADSs.

Our ordinary shares are quoted in Australian dollars on the ASX and the ADSs are quoted in U.S. dollars on NASDAQ. Movements in the Australian dollar/U.S. dollar exchange rate may adversely affect the U.S. dollar price of the ADSs. In the past year the Australian dollar has generally weakened against the U.S. dollar. However, this trend may not continue and may be reversed.

Australian takeover laws may discourage takeover offers being made for us or may discourage the acquisition of a significant position in our ordinary shares and ADSs.

We are incorporated in Australia and are subject to the takeover laws of Australia. Among other things, we are subject to the Australian Corporations Act 2001, or the Corporations Act. Subject to a range of exceptions, the Corporations Act prohibits the acquisition of a direct or indirect interest in our issued voting shares if the acquisition of that interest will lead to a person’s voting power in us increasing to more than 20%, or increasing from a starting point that is above 20% and below 90%. Australian takeover laws may discourage takeover offers being made for us or may discourage the acquisition of a significant position in our ordinary shares. This may have the ancillary effect of entrenching our board of directors and may deprive or limit our shareholders’ and ADS holders’ opportunity to sell their ordinary shares and ADSs and may further restrict the ability of our shareholders and ADS holders to obtain a premium from such transactions. See Item 10.B “Additional Information – Memorandum and Articles of Association.”

Item 4. Information on the Company

A. History and development of the Company

Kazia Therapeutics Limited (“Kazia”), a public company limited by shares, was incorporated in March 1994 under the laws of New South Wales, Australia. Kazia is registered and operates under the Australian Corporations Act 2001.

Kazia has its registered office at Three International Towers, Level 24, 300 Barangaroo Avenue, Sydney, NSW 2000, Australia. Its telephone number and other contact details are: Phone +61-2-9472 4101; email info@kaziatherapeutics.com; and website, www.kaziatherapeutics.com (the information contained in the website does not form part of the Annual Report). Our agent for service of process in the United States is Vcorp Services, LLC, 25 Robert Pitt Drive, Suite 204, Monsey, New York 10952..

The Company’s Ordinary Shares are listed on the Australian Securities Exchange (“ASX”) under the symbol ‘KZA’ and its ADSs, each representing ten Ordinary Shares, trade on the NASDAQ Capital Market under the symbol ‘KZIA’. The Depositary for the Company’s ADSs is The Bank of New York Mellon, 240 Greenwich Street, New York, NY 10286. All information we file with the SEC is available through the SEC’s Electronic Data Gathering, Analysis and Retrieval system, which may be accessed through the SEC’s website at www.sec.gov.

B. Business overview

The ongoing principal business of the Company has been pharmaceutical drug development. The Company is an emerging oncology-focused biotechnology company that has a portfolio of development candidates, diversified across several distinct technologies, with the potential to yield first-in-class and best-in-class agents in a range of oncology indications. The lead drug candidate is paxalisib (formerly GDC-0084), a small molecule inhibitor of the PI3K / AKT / mTOR pathway, which is involved in ten active trials as follows:

• a Kazia-sponsored phase II clinical trial to examine paxalisib in newly diagnosed glioblastoma, the most common and most aggressive form of primary brain tumor in adults;

• a phase II / III adaptive registrational study in glioblastoma, sponsored by the Global Coalition for Adaptive Research;

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• a phase I clinical trial being conducted by St Jude Children’s Hospital, examining paxalisib in diffuse intrinsic pontine glioma (DIPG), a rare but very aggressive form of childhood brain cancer;

• a phase II study being conducted at Dana-Farber Cancer Institute, examining HER2+ breast cancer brain metastases – breast cancer which has spread to the brain – in combination with Herceptin (trastuzumab);

• an NCI funded multi-drug study of brain metastases – cancer which has spread to the brain from any primary tumor. This study is a phase II trial and is being conducted by the Alliance for Clinical Trials in Oncology;

• Memorial Sloan Kettering Cancer Center is investigating the potential use of paxalisib in combination with radiotherapy in a phase I clinical trial for cancer which has spread to the brain;

• A phase II clinical trial is being conducted by Weill Cornell Cancer Centre to examine the impact of a ketogenic diet on the use of paxalisib in glioblastoma;

• Dana-Farber Cancer Institute is conducting a phase II trial examining paxalisib in primary CNS lymphoma;

• Pacific Pediatric Neuro-Oncology Consortium is examining paxalisib in DIPG and DMGs (childhood brain cancer) in a phase II study; and

• A human ‘ADME’ study (also called a ‘mass-balance’ study), which is designed to better understand the elimination of paxalisib from the body, and which is required for eventual product approval.

The following graphic illustrates the primary Kazia trials currently in progress.

Cantrixil (TRX-E-002-1) was previously under development by the Company as a potential therapy for ovarian cancer, and the Company has recently licensed the global rights to Oasmia Pharmaceutical AB (“Oasmia”), a Swedish company.

EVT801 is the Company’s second clinical asset after the global rights were licensed from Evotec SE in a recent transaction which is detailed below.

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Research and Development

Paxalisib (formerly GDC-0084)

The company’s lead development candidate is paxalisib (formerly known as GDC-0084), a small molecule, brain-penetrant inhibitor of the PI3K / Akt / mTor pathway, that is being developed as a potential therapy for glioblastoma (GBM), the most common and most aggressive form of primary brain tumour in adults, as well as other forms of brain cancer. Paxalisib is orally administered and is presented in a 15mg capsule formulation. The development candidate is the subject of IND 112,608 with the US FDA.

Paxalisib was developed by Genentech, Inc (South San Francisco, California) and the company entered into a worldwide exclusive license for the asset in October 2016. Prior to this transaction, Genentech had completed an extensive preclinical development program that provided convincing validation for paxalisib as a potential drug for brain cancer. Genentech also completed a phase I clinical trial in 47 patients with advanced recurrent grade III and grade IV glioma (NCT01547546). The most common adverse events were oral mucositis and hyperglycemia. Per RANO criteria, 40% of patients exhibited a best observable response of stable disease, and 26% demonstrated a metabolic partial response on FDG-PET.

The development candidate was granted the International Non-Proprietary Name (INN) ‘paxalisib’ by the World Health Organisation in December 2019. This was confirmed as the United States Adopted Name (USAN) by the USAN Council in April 2020.

Paxalisib is a potent and selective inhibitor of all four isoforms of phosphoinositide-3-kinase (PI3K) and a moderate inhibitor of the mammalian target of rapamycin (mTOR). The PI3K / Akt / mTOR signaling axis has been shown to be dysregulated in approximately 85-90% of cases of glioblastoma, per Cancer Genome Atlas, and is considered a promising target in this disease. More generally, five PI3K inhibitors have thus far been approved by FDA, for a range of hematological malignancies and solid tumors, making this a well-validated target in cancer. Paxalisib is distinguished from these products by the fact that it is the only PI3K inhibitor in mainstream clinical development which is known to cross the blood-brain barrier, a crucial prerequisite for any novel treatment in brain cancer.

Paxalisib’s mechanism is therefore entirely distinct from that of temozolomide, the existing FDA-approved standard of care treatment. Temozolomide functions primarily by alkylating guanine residues in DNA, thereby inhibiting cell division in the rapidly-growing tumor. Paxalisib, by contrast, inhibits a biochemical control signal, and is therefore associated with a very different resistance and toxicity profile.

Paxalisib is the subject of granted or pending composition-of-matter patents in all key territories. In general, the expiry of these patents is in December 2031. However, the company expects that it will be able to secure patent term extensions in the most substantial markets, including US, EU, China, Japan, and Korea, and that these extensions will provide effective protection until 2036. In addition, the company has recently received notice of grant for a patent protecting the manufacturing process associated with paxalisib, and this will provide an additional layer of protection in relevant territories until 2036.

Paxalisib was granted orphan drug designation (ODD) by FDA for glioblastoma in February 2018, and for the broader indication of glioma in August 2020. The development candidate also received Fast Track designation (FTD) for glioblastoma in August 2020, and Rare Pediatric Disease Designation (RPDD) for diffuse midline gliomas in August 2020. Collectively, these special designations provide paxalisib with enhanced access to FDA, a waiver of PDUFA fees, a period of data exclusivity and, in the specific case of RPDD, the potential to secure a pediatric Priority Review Voucher (pPRV) should paxalisib be approved in this indication.

Phase II Clinical Trial in Newly Diagnosed Glioblastoma with Unmethylated MGMT Status (NCT03522298)

A company-sponsored phase II study of paxalisib in newly diagnosed patients with unmethylated MGMT promotor status (NCT03522298) remains ongoing. In November 2020, an interim analysis was presented at the Society for Neuro-Oncology (SNO) Annual Meeting. This analysis showed a median progression-free survival (PFS) of 8.4 months, and a median overall survival (OS) of 17.5 months, each of which compare favourably to the corresponding figures of 5.3 months and 12.7 months which are associated in this patient population with temozolomide, the existing standard of care. The safety profile of paxalisib continues to appear highly favourable, with rash, hyperglycemia, and oral mucositis representing the most common toxicities. In April 2021, the company presented additional interim data focusing on pharmacokinetics at the American Association for Cancer Research Annual Meeting. This data supported 60mg as the go-forward dose, and suggested no significant food effect, allowing for both fed and fasted administration in future studies.

In May 2021, the last patient in the phase II study experienced disease progression and came off study drug, after some 2.3 years of treatment. The study is now in survival follow-up, with final data expected by end of CY2021.

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Phase II / III Clinical Trial in Glioblastoma (GBM AGILE) (NCT03970447)

Paxalisib commenced recruitment to GBM AGILE (NCT03970447), a phase II / III adaptive clinical trial in glioblastoma, in January 2021. GBM AGILE is sponsored by the Global Coalition for Adaptive Research, a US-based 501©(3) non-profit organisation dedicated to advancing the development of new therapies via the application of cutting-edge statistical methodologies. The study is a platform study, or master protocol study, in which multiple experimental agents are evaluated in parallel, and are compared against a shared control arm. GBM AGILE uses an adaptive Bayesian statistical design to ensure that only the number of patients required to reach a definitive answer are enrolled. Three patient populations are included in the study: newly diagnosed patients with unmethylated MGMT promotor status, newly diagnosed patients with methylated MGMT promotor status, and recurrent patients. Paxalisib is participating in the first and third of these groups but will not examine patients with methylated MGMT promotor status in this study.

As at 30 June 2021, three experimental agents are enrolling patients in GBM AGILE: Bayer’s regorafenib, Kazia’s paxalisib, and VAL-083, manufactured by Kintara Therapeutics. The study has screened approximately 650 patients, and approximately two-dozen study sites are open to the paxalisib arm, with more expected to open during 2H CY2021.

GBM AGILE is intended to serve as the registration study for paxalisib in glioblastoma. The study has been designed with registrational intent, and FDA has indicated that it considers the study suitable for this purpose.

Phase II Study in Glioblastoma in Combination with Ketogenesis

In June 2021, the company entered into an agreement with the Joan & Sanford I Weill Medical College of Cornell University in New York, NY, known generally as Weill Cornell Medicine, for an investigator-initiated phase II clinical trial combining paxalisib with ketogenesis in patients with newly-diagnosed and recurrent glioblastoma. In addition to the general interest in ketogenic diets as a potential adjunct to treatment for various forms of cancer, research by Professor Lew Cantley and colleagues has demonstrated the potential for insulin to antagonise PI3K inhibition. Administering a PI3K inhibitor in the context of minimal insulin secretion should allow the drug to achieve its full potential, and a combination of ketogenic diet and metformin will be used in this study to achieve a hypoinsulinaemic state. Professor Cantley serves as a scientific advisor to the study, and Dr Howard Fine, a highly experienced neuro-oncologist, will serve as Principal Investigator. The study is expected to commence recruitment during 2H CY2021.

Phase I Study in Diffuse Intrinsic Pontine Glioma (DIPG) (NCT03696355)

An investigator-initiated phase I study of paxalisib in children with diffuse intrinsic pontine glioma (DIPG) and other diffuse midline gliomas (DMGs) (NCT03696355), sponsored by St Jude Children’s Research Hospital in Memphis, TN, reported initial interim data in an oral presentation at the SNO Annual Meeting in November 2020. The study met its primary objective and determined a maximum tolerated dose for paediatric use of 27 mg/m2. 27 patients were recruited, of whom 24 received at least one dose of paxalisib. The safety profile and pharmacokinetics were highly consistent with the adult data. The study had not at that stage demonstrated a survival benefit. As at 30 June 2021, a number of patients remain in survival follow-up, and final data is expected during FY2022.

Phase II Study in Diffuse Intrinsic Pontine Glioma (DIPG) (NCT05009992)

In December 2020, the company entered into a letter of intent with the Pacific Pediatric Neuro-Oncology Consortium (PNOC) to execute an investigator-initiated phase II adaptive study of paxalisib in patients with DIPG and other DMGs (), a group which collectively constitutes one of the most aggressive childhood cancers. The study will explore paxalisib in combination with ONC-201, a small-molecule investigational new drug which targets dopamine receptor D2 (DRD2), and which is manufactured by Oncoceutics, Inc, a wholly-owned subsidiary of Chimerix, Inc. The St Jude phase I study in DIPG has already provided invaluable information regarding dosing and safety of paxalisib in a paediatric population, but it has always been assumed that combination therapy would be required to achieve meaningful efficacy in such an aggressive tumour. Research by Professor Matt Dun at the Hunter Medical Research Institute in Newcastle, Australia, has shown compelling evidence of combinatorial synergy between paxalisib and ONC-201, and so the PNOC study will investigate this combination, among others, in patients. The study is expected to commence recruitment in 2H CY2021.

Phase II Study in Primary CNS Lymphoma (PCNSL) (NCT04906096)

In September 2020, the company signed an agreement with Dana-Farber Cancer Institute in Boston, MA, for an investigator-initiated phase II clinical study of paxalisib in patients with primary CNS lymphoma (PCNSL) (NCT04906096). This study commenced recruitment in June 2021. Four of the five FDA-approved PI3K inhibitors are indicated for various forms of lymphoma, so this is considered a high-potential indication for paxalisib. The unique brain-penetrant qualities of paxalisib make it ideally suitable for investigation in this patient group. The study is expected to recruit around 25 patients, and to run for approximately two years. The Principal Investigator is Professor Lakshmi Nayak, a highly experienced clinical researcher in brain cancer, with a specialist interest in PCNSL. The study commenced recruitment in June 2021.

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Phase I Study in Brain Metastases in Combination with Radiotherapy (NCT04192981)

Dr T Jonathan Yang is the Principal Investigator to a phase I study in patients with brain metastases and leptomeningeal metastases, in which paxalisib is administered in combination with radiotherapy (NCT04192981), sponsored by Memorial Sloan-Kettering Cancer Center in New York, NY. This study is expected to provide initial interim data during FY2022.

Phase II Study in HER2+ Breast Cancer Brain Metastases in Combination with Trastuzumab (NCT03765983)

Dr Jose Pablo Leone is the Principal Investigator to a phase II study in patients with HER2-positive breast cancer brain metastases, in which paxalisib is administered in combination with Herceptin (trastuzumab) (NCT03765983), sponsored by Dana-Farber Cancer Institute in Boston, MA. This study is expected to provide initial interim data during FY2022.

Phase II Genomically-Guided Study in Brain Metastases (NCT03994796)

The Alliance for Clinical Trials in Oncology is sponsoring a phase II multi-drug study of multiple agents in the treatment of brain metastases from any primary tumour (NCT03994796). The study establishes a genomic profile for patients at entry and then assigns them, on the basis of the predominant mutational profile in their tumour, to receive either abemaciclib (CDK4/6 mutations), entrectanib (ROS/Trk mutations), or paxalisib (PI3K mutations). This study is expected to provide initial interim data during FY2022.

EVT801

The company’s second development candidate is EVT801, a small-molecule selective inhibitor of vascular endothelial growth factor receptor 3 (VEGFR3). EVT801 was originally discovered by Sanofi SA and was licensed to Evotec SE as part of a broader transaction. Evotec conducted an extensive program of preclinical development, which showed compelling evidence of activity in a broad range of animal models. The drug was licensed to Kazia in April 2021.

EVT801 is protected by granted or pending composition-of-matter patents in all key territories, with exclusivity generally through to the early 2030s.

For several decades, it has been clear that growing tumours require an extensive network of newly formed blood vessels and lymphatic vessels to satisfy their substantial nutrient requirements. Drugs which inhibit the formation of new blood vessels (angiogenesis inhibitors) have proven effective in a wide range of solid tumours, with Avastin (bevacizumab) being the best-known example of the class. However, the use of such drugs is limited by hypoxia-induced resistance mechanisms and, in the case of many small-molecule inhibitors, by toxicity. EVT801 has been designed to respond to these challenges by selectively targeting lymphangiogenesis, the formation of new lymphatic vessels. Doing so, and with a high degree of selectivity, is expected to provide many of the same benefits as inhibition of angiogenesis, but without the attendant problems of resistance and toxicity.

In addition, drugs which target VEGF receptors have shown the potential to alter the population of immune cells within the tumour micro-environment, thereby potentially making ‘cold’ tumours more susceptible to immuno-oncology agents such as checkpoint inhibitors. A wealth of preclinical evidence supports this hypothesis with EVT801 and provides a second and almost entirely distinct mechanism of action through which the drug may provide benefit to cancer patients.

Kazia has initiated work on a phase I clinical trial of EVT801, which will seek to explore both of these mechanisms (inhibition of lymphangiogenesis and modulation of tumour immune micro-environment), as well as provide critical information regarding the safety, tolerability, and pharmacokinetics of the drug. The planned phase I study will be initiated at two trial sites in France and will aim to recruit up to 96 patients with advanced cancer. The study is expected to commence recruitment by the end of CY2021.

We have a reasonable expectation that during fiscal 2022:

• Final results will be reported from the phase II clinical trial of paxalisib in glioblastoma;

• Interim results will be reported from the phase II clinical trial of paxalisib in combination with trastuzumab in breast cancer metastases;

• Interim results will be reported from the phase II genomically-guided study of paxalisib in brain metastases;

• Interim results will be reported from the phase I study of paxalisib in combination with radiotherapy in brain metastases;

• Final data will be reported from the phase I study of paxalisib in children with diffuse intrinsic pontine glioma (DIPG);

• The phase II study of paxalisib in combination with a ketogenic diet in glioblastoma will commence recruitment;

• The phase II study of paxalisib in combination with ONC-201 in DIPG and DMGs will commence recruitment; and

• The phase I study of EVT801 in patients with advanced solid tumours will commence recruitment.

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In parallel, the Company continues to actively explore licensing and partnering opportunities with other companies that have the potential to effect further refinements in the scope of the Company’s business.

Patent Protection

The Company has an aggressive global Intellectual Property (“IP”) strategy to protect its key assets and we have partnered with a global patent law firm to lodge patents that offer the best possible protection for our assets. The patent strategy is adapted for each technology platform and the principle mode of protection is through the patenting procedure, seeking to obtain exclusive licenses for all its key inventions and drug pipeline. The overarching strategy in the IP portfolio is to cover the three critical corner stones of pharmaceutical patent: composition of matter (the breadth structures covered in the patent), method of manufacture (the chemical processes used to manufacture the compounds disclosed in the patent) and method of use. Patents are submitted initially as provisional applications and after 12 months’ progress through to a Patent Cooperation Treaty (“PCT”) application.

Drug discovery/development efforts are contributing to our pipeline with our other technology platforms also delivering hit and lead drug candidates. As the research programs reveal new hit molecules, these are protected through lodging patents. The Company will continue to pursue a broad patent filing strategy based on multiple jurisdictions with a focus on those member countries offering the most significant market opportunities for future development.

Regulatory requirements

Australian Regulatory Requirements

The Therapeutic Goods Act 1989 (“1989 Act”), sets out the legal requirements for the import, export, manufacture and supply of pharmaceutical products in Australia. The 1989 Act requires that all pharmaceutical products to be imported into, supplied in, manufactured in or exported from Australia be included in the Australian Register of Therapeutic Goods (“ARTG”), unless specifically exempted under the Act.

Medicines with a higher level of risk (prescription medicines, some non-prescription medicines) are evaluated for quality, safety and efficacy and are registered on the ARTG. Medicines with a lower risk (many over the counter medicines including vitamins) are assessed only for quality and safety. Medicines included in the ARTG can be identified by the AUST R number (for registered medicines) or an AUST L number (for listed medicines) which appears on the packaging of the medicine.

In order to ensure that a product can be included in the ARTG, a sponsoring company must make an application to the Therapeutic Goods Administration (“TGA”). The application usually consists of a form accompanied by data (based on the EU requirements) to support the quality, safety and efficacy of the product for its intended use and payment of a fee. Application details are available on the TGA website www.tga.gov.au.

The first phase of evaluation, known as the Application Entry Process, is usually a short period during which an application is assessed at an administrative level to ensure that it complies with the basic guidelines. The TGA may request further details from the applicant and may agree with sponsors that additional data (which while not actually required by the application, could enhance the assessment outcome) may be submitted later at an agreed time. The TGA must decide within at least 40 working days whether it will accept the application for evaluation.

Once an application is accepted for evaluation, aspects of the data provided are allocated to evaluators within the different relevant sections, who prepare clinical evaluation reports. Following evaluation, the chemistry, quality control bioavailability and pharmacokinetics aspects of a product may be referred to a Pharmaceutical Sub-Committee (“PSC”), which is a sub-committee of the TGA prescription medicine expert advisory committee, the Advisory Committee on Prescriptive Medicines (“ACPM”) to review the relevant clinical evaluation reports.

The clinical evaluation reports (along with any resolutions of the ACPM sub-committee) are sent to the sponsoring company who then has the opportunity to comment on the views expressed within the evaluation report, provide corrections and to submit supplementary data to address any issues raised in the evaluation reports.

Once the evaluations are complete, the TGA prepares a summary document on the key issues on which advice will be sought from either the ACPM (for new medicines) or from the Peer Review Committee (“PRC”) for extensions to products which are already registered. This summary is sent to the sponsoring company, which is able to submit a response to the ACPM or PRC dealing with issues raised in the summary and those not previously addressed in the evaluation report. The ACPM/PRC provide independent advice on the quality, risk/benefit, effectiveness and access of the product and conduct medical and scientific evaluations of the application. The ACPM meets every two months to examine the applications referred by the TGA and its resolutions are provided to the sponsoring company within five working days after the ACPM meeting.

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The TGA takes into account the advice of the ACPM or PRC in reaching a decision to approve or reject a product. Any approval for registration on the ARTG may have conditions associated with it.

From the time that the TGA accepts the initial application for evaluation, the TGA must complete the evaluation and make a decision on the registration of the product within at least 255 working days. If not completed within 255 working days, the TGA forfeits 25% of the evaluation fee otherwise payable by the sponsor, but any time spent waiting for a response from the sponsor is not included in the 255 working days. The TGA also has a system of priority evaluation for products that meet certain criteria, including where the product is a new chemical entity that it is not otherwise available on the market as an approved product, and is for the treatment of a serious, life-threatening illness for which other therapies are either ineffective or not available.

U.S. Regulatory Requirements

The FDA regulates and imposes substantial requirements upon the research, development, pre-clinical and clinical testing, labelling, manufacture, quality control, storage, approval, advertising, promotion, marketing, distribution, import and export of pharmaceutical products including drugs and biologics, as well as significant reporting and record-keeping obligations. State governments may also impose obligations in these areas.

In the United States, pharmaceutical products are regulated by the FDA under the Federal Food, Drug, and Cosmetic Act (“FDCA”), and other laws in the case of biologics, the Public Health Service Act and other acts that implement regulations. The Company believes that the FDA will regulate its products as drugs. The process required by the FDA before drugs may be marketed in the United States generally involves the following:

• pre-clinical laboratory evaluations, including formulation and stability testing, and animal tests performed under the FDA’s Good Laboratory Practices regulations to assess pharmacological activity and toxicity potential;

• submission and approval of an IND Application, including results of pre-clinical studies, clinical experience, manufacturing information, and protocols for clinical tests, which must become effective before clinical trials may begin in the United States;

• obtaining approval of Institutional Review Boards (“IRBs”), to administer the products to human subjects in clinical trials;

• adequate and well-controlled human clinical trials to establish the safety and efficacy of the product for the product’s intended use;

• development of manufacturing processes which conform to FDA current Good Manufacturing Practices (“cGMPs”), as confirmed by FDA inspection;

• submission of results for pre-clinical and clinical studies, and chemistry, manufacture and control information on the product to the FDA in a New Drug Approval (“NDA”) Application; and

• FDA review and approval of an NDA, prior to any commercial sale, promotion or shipment of a product.

The testing and approval process requires substantial time, effort, and financial resources, and the Company cannot be certain that any approval will be granted on a timely basis, if at all.

The results of the pre-clinical studies, clinical experience together with initial specified manufacturing information, the proposed clinical trial protocol, and information about the participating investigators are submitted to the FDA as part of an IND, which must become effective before the Company may begin human clinical trials in the U.S. Additionally, an independent IRB must review and approve each study protocol and oversee conduct of the trial. An IND becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day period, raises concerns or questions about the conduct of the trials as outlined in the IND and imposes a clinical hold. If the FDA imposes a clinical hold, the IND sponsor must resolve the FDA’s concerns before clinical trials can begin. Pre-clinical tests and studies can take several years to complete, and there is no guarantee that an IND submitted, based on such tests and studies, will become effective within any specific time period, if at all.

Human clinical trials are typically conducted in three sequential phases that may overlap, which are:

• Phase I: The drug is initially introduced into healthy human subjects or patients and tested for safety and dosage tolerance. For oncology medicines, patients with the target disease are used rather than healthy patients. Absorption, metabolism, distribution, and excretion testing, among other tests, are generally performed at this stage. These studies may also provide early evidence of effectiveness. The maximum tolerated dose of the drug may be calculated from Phase I studies;

• Phase II: The drug is studied in controlled, exploratory therapeutic trials in a limited number of subjects with the disease or medical condition for which the new drug is intended to be used in order to identify possible adverse effects and safety risks, to determine the preliminary or potential efficacy of the product for specific targeted diseases or medical conditions, and to determine dosage tolerance and the optimal effective dose; and

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• Phase III: While Phase II studies demonstrate that a specific dosage range of the drug is likely to be effective and the drug has an acceptable safety profile, controlled, large-scale therapeutic, Phase III trials are undertaken at multiple study sites to demonstrate clinical efficacy and to further test for safety in an expanded patient population. These studies are used to evaluate the overall benefit – risk relationship of the drug and provide a basis for physician labelling.

The Company cannot be certain that it will successfully complete Phase I, Phase II or Phase III testing of its products within any specific time period, if at all. Furthermore, the FDA, the IRB or the Company may suspend or terminate clinical trials at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk.

Results of pre-clinical studies and clinical trials, as well as detailed information about the manufacturing process, quality control methods, and product composition, among other things, are submitted to the FDA as part of an NDA seeking approval to market and commercially distribute the product on the basis of a determination that the product is safe and effective for its intended use. Before approving an NDA, the FDA will inspect the facilities at which the product is manufactured and will not approve the product unless GMP compliance is satisfactory. If applicable regulatory criteria are not satisfied, the FDA may deny the NDA or require additional testing or information. As a condition of approval, the FDA also may require post-marketing testing or surveillance to monitor the product’s safety or efficacy. Even after an NDA is approved, the FDA may impose additional obligations or restrictions (such as labelling changes), or even suspend or withdraw a product approval on the basis of data that arise after the product reaches the market, or if compliance with regulatory standards is not maintained. The Company cannot be certain that the FDA on a timely basis, if at all will approve any NDA it submits. Also, any such approval may limit the indicated uses for which the product may be marketed. Any refusal to approve, delay in approval, suspension or withdrawal of approval, or restrictions on indicated uses could have a material adverse impact on the Company’s business prospects.

A user fee, pursuant to the requirements of the Prescription Drug User Fee Act (“PDUFA”), and its amendments, applies to NDAs. The FDA adjusts the PDUFA user fees on an annual basis. PDUFA also imposes an annual product fee for prescription drugs and biologics, and an annual establishment fee on facilities used to manufacture prescription drugs and biologics. A written request can be submitted for a waiver under certain circumstances. Waivers may be possible for the application fee for the first human drug application that is filed by a small business, as defined by the FDCA, but there are no small business waivers for product or establishment fees. Waivers may also be possible for one or more fees, upon written request, when a waiver or reduction is necessary to protect the public health, the user fees would present a significant barrier to innovation, or the fees are anticipated to exceed the present or future costs incurred by FDA. The Company is not at the stage of development with its products where it is subject to these fees, but they are significant expenditures that may be incurred in the future and must be paid at the time of application submissions to FDA.

Satisfaction of FDA requirements typically takes several years. The actual time required varies substantially, based upon the type, complexity, and novelty of the pharmaceutical product, among other things. Government regulation imposes costly and time-consuming requirements and restrictions throughout the product life cycle and may delay product marketing for a considerable period of time, limit product marketing, or prevent marketing altogether. Success in pre-clinical or early stage clinical trials does not ensure success in later stage clinical trials. Data obtained from pre-clinical and clinical activities are not always conclusive and may be susceptible to varying interpretations that could delay, limit, or prevent marketing approval. Even if a product receives marketing approval, the approval is limited to specific clinical indications. Further, even after marketing approval is obtained, the discovery of previously unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product from the market.

After product approval, there are continuing significant regulatory requirements imposed by the FDA, including record-keeping requirements, obligations to report adverse events in patients using the products, and restrictions on advertising and promotional activities. Quality control and manufacturing procedures must continue to conform to GMPs, and the FDA periodically inspects facilities to assess GMP compliance. Additionally, post-approval changes in ingredient composition, manufacturing processes or facilities, product labelling, or other areas may require submission of an NDA Supplement to the FDA for review and approval. New indications will require additional clinical studies and submission of an NDA Supplement. Failure to comply with FDA regulatory requirements may result in an enforcement action by the FDA, including warning letters, product recalls, suspension or revocation of product approval, seizure of product to prevent distribution, impositions of injunctions prohibiting product manufacture or distribution, and civil and criminal penalties. Maintaining compliance is costly and time-consuming. The Company cannot be certain that it, or its present or future suppliers or third-party manufacturers, will be able to comply with all FDA regulatory requirements, and potential consequences of noncompliance could have a material adverse impact on its business prospects.

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The FDA’s policies may change, and additional governmental regulations may be enacted that could delay, limit, or prevent regulatory approval of the Company’s products or affect its ability to manufacture, market, or distribute its products after approval. Moreover, increased attention to the containment of healthcare costs in the U.S. and in foreign markets could result in new government regulations that could have a material adverse effect on the business. The Company’s failure to obtain coverage, an adequate level of reimbursement, or acceptable prices for future products could diminish any revenues the Company may be able to generate. The Company’s ability to commercialize future products will depend in part on the extent to which coverage and reimbursement for the products will be available from government and health administration authorities, private health insurers, and other third-party payers. EU member states and U.S. government and other third-party payers increasingly are attempting to contain healthcare costs by consideration of new laws and regulations limiting both coverage and the level of reimbursement for new drugs. The Company cannot predict the likelihood, nature or extent of adverse governmental regulation that might arise from future legislative or administrative action, either in the U.S. or abroad.

The Company’s activities may also be subject to state laws and regulations that affect its ability to develop and sell products. The Company is also subject to numerous federal, state, and local laws relating to such matters as safe working conditions, clinical, laboratory, and manufacturing practices, environmental protection, fire hazard control, and disposal of hazardous or potentially hazardous substances. The Company may incur significant costs to comply with such laws and regulations now or in the future, and the failure to comply may have a material adverse impact on the Company.

The FDCA includes provisions designed to facilitate the development and expedite the review of drugs and biological products intended for treatment of serious or life-threatening conditions that demonstrate the potential to address unmet medical needs for such conditions. These provisions set forth a procedure for designation of a drug as a “fast track product”. The fast track designation applies to the combination of the product and specific indication for which it is being studied. A product designated as fast track is ordinarily eligible for additional programs for expediting development and review, but products that are not in fast-track drug development programs may also be able to take advantage of these programs if they meet the necessary requirements. These programs include priority review of NDAs and accelerated approval. Drug approval under the accelerated approval regulations may be based on evidence of clinical effect on a surrogate endpoint that is reasonably likely to predict clinical benefit. A post-marketing clinical study will be required to verify clinical benefit, and other restrictions to assure safe use may be imposed.

Under the Drug Price Competition and Patent Term Restoration Act of 1984, a sponsor may obtain marketing exclusivity for a period of time following FDA approval of certain drug applications, regardless of patent status, if the drug is a new chemical entity or if new clinical studies were required to support the marketing application for the drug. This marketing exclusivity prevents a third party from obtaining FDA approval for an identical or nearly identical drug under an Abbreviated New Drug Application or a “505(b)(2) New Drug Application”. The statute also allows a patent owner to obtain an extension of applicable patent terms for a period equal to one-half the period of time elapsed between the filing of an IND and the filing of the corresponding NDA plus the period of time between the filing of the NDA and FDA approval, with reductions taken for any time an applicant did not act with due diligence. There is a five-year maximum patent extension and a maximum of 14 years protection from product approval. The Company cannot be certain that it will be able to take advantage of either the patent term extension or marketing exclusivity provisions of these laws.

European Union Regulatory Requirements

Outside the United States, the Company’s ability to market its products will also be contingent upon receiving marketing authorizations from the appropriate regulatory authorities and compliance with applicable post-approval regulatory requirements. Although the specific requirements and restrictions vary from country to country, as a general matter, foreign regulatory systems include risks similar to those associated with FDA regulation, described above. Under EU regulatory systems, marketing authorizations may be submitted either under a centralized or a national procedure. Under the centralized procedure, a single application to the European Medicines Agency (“EMA”) leads to an approval granted by the European Commission that permits the marketing of the product throughout the EU. The centralized procedure is mandatory for certain classes of medicinal products, but optional for others. For example, all medicinal products developed by certain biotechnological means, and those developed for cancer and other specified diseases and disorders, must be authorized via the centralized procedure. The Company assumes that the centralized procedure will apply to its products that are developed by means of a biotechnology process. The national procedure is used for products not requiring authorization by the centralized procedure. Under the national procedure, an application for a marketing authorization is submitted to the competent authority of one-member state of the EU. The holders of a national marketing authorization may submit further applications to the competent authorities of the remaining member states via either the decentralized or mutual recognition procedure. The decentralized procedure enables applicants to submit an identical application to the competent authorities of all member states where approval is sought at the same time as the first application, while under the mutual recognition procedure, products are authorized initially in one-member state, and other member states where approval is sought are then requested to recognize the original authorization based upon an assessment report prepared by the original authorizing competent authority. Both the decentralized and mutual recognition procedures should take no longer than 90 days, but if one-member state makes an objection, which under the legislation can only be based on a possible risk to human health, the application will be automatically referred to the Committee for Medicinal Products for Human Use (“CHMP”) of the EMA. If a referral for arbitration is made, the procedure is suspended. However, member states that have already approved the application may, at the request of the applicant, authorize the product in question without waiting for the result of the arbitration. Such authorizations will be without prejudice to the outcome of the arbitration. For all other concerned member states, the opinion of the CHMP, which is binding, could support or reject the objection or alternatively could reach a compromise position acceptable to all EU countries concerned. The arbitration procedure may take an additional year before a final decision is reached and may require the delivery of additional data.

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As with FDA approval, the Company may not be able to secure regulatory approvals in the EU in a timely manner, if at all. Additionally, as in the U.S., post-approval regulatory requirements, such as those regarding product manufacture, marketing, or distribution, would apply to any product that is approved in the EU, and failure to comply with such obligations could have a material adverse effect on the Company’s ability to successfully commercialize any product.

The conduct of clinical trials in the EU is governed by the European Clinical Trials Directive (2001/20/EC), which was implemented in May 2004. This Directive governs how regulatory bodies in member states control clinical trials. No clinical trial may be started without a clinical trial authorization granted by the national competent authority and favorable ethics approval.

Accordingly, there is a marked degree of change and uncertainty both in the regulation of clinical trials and in respect of marketing authorizations that face the Company or its products in the EU.

The Company has met the compliance requirements for ASX listings and accordingly has not been in breach of those requirements.

Product and Corporate Developments during Fiscal 2021

The Company continued to pursue its strategy of focusing resources on clinical programs, being those most likely to provide a return to shareholders.

In October 2020, the Company raised $23.6 million (net of costs) from an accelerated non-renounceable entitlement offer to industry investors, and in April 2021, raised US$4 million as a result of a placement to Simcere.

In March 2021, the Company partnered our legacy asset, Cantrixil (TRX-E-002-1) to Oasmia for US$4 million up front, up to US$42 million in contingent milestone payments and double-digit royalties.

Also in March 2021, the Company partnered paxalisib for Greater China to Simcere for US$11 million up front comprising US$7 million in cash and US$4 million in equity investment, and up to US$281 million in contingent milestones and tiered mid-teen royalties.

In April 2021, the Company in-licensed EVT801, a selective small-molecule inhibitor of VEGFR3 from Evotec SE of Germany for €1 million up front, approximately €308 million in contingent milestones and single-digit royalties.

The funds supplied by the capital raises, as well as the up-front payments from the two licensing transactions, funded the operations of the Company for fiscal 2021 and the up-front payment for EVT801, and will provide funding for the ongoing studies being conducted for both assets.

As well as our own ongoing clinical trials, paxalisib is now also involved in a further seven clinical trials, all being conducted by world renowned research organizations and principally funded by parties other than Kazia, giving us multiple opportunities to realise value from this drug. EVT801 is expected to enter the clinic later in 2021.

The Company has continued to make all efforts to improve operating efficiency and maintain the current low rate of G&A costs, allowing the bulk of the company’s funds to be directed towards our research and development activities. Cash outlaid in relation to our clinical programs represented approximately 80% of the total cash outlay for the year, as compared to 72% in the prior fiscal period.

C. Organizational structure

Kazia Therapeutics Limited is incorporated in Australia and has the following wholly-owned subsidiaries:

Name	Country of incorporation
Kazia Laboratories Pty Ltd	Australia
Kazia Research Pty Ltd	Australia
Kazia Therapeutics Inc.	United States (Delaware)
Glioblast Pty Ltd Kazia Therapeutics (Hong Kong) Limited	Australia Hong Kong

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D. Property, plant and equipment

During fiscal 2021, the Company continued to work out of a serviced office in Sydney that is subject to a renewable one-year workspace license agreement.

Item 4A. Unresolved Staff Comments

None.

Item 5. Operating and Financial Review and Prospects

Critical accounting policies

We prepare our financial statements in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB). As such, we are required to make certain estimates, judgments, and assumptions that management believes are reasonable based upon the information available. These estimates, judgments and assumptions affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the periods presented. The critical accounting policies are summarized in Item 18. “Financial Statements—Note 3 – Critical Accounting Policies”.

The following discussion and analysis should be read in conjunction with Item 18. “Financial Statements” included below. Operating results are not necessarily indicative of results that may occur in future periods. This discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. The actual results may differ materially from those anticipated in the forward-looking statements as a result of many factors including, but not limited to, those set forth under “Forward-Looking Statements” and “Risk Factors” in Item 3 “Key Information” included above in this Annual Report on Form 20-F. All forward-looking statements included in this document are based on the information available to the Company on the date of this document and the Company assumes no obligation to update any forward-looking statements contained in this Annual Report on Form 20-F.

A. Operating results

The following discussion relates to our consolidated results of operations, financial condition and capital resources. You should read this discussion in conjunction with our consolidated financial statements and the notes thereto contained elsewhere in this report.

The following tables provide a summary of revenues and income for the past three fiscal years:

	For the fiscal year ended June 30,
	2021		2020		2019
	A$’000		A$’000		A$’000
Revenue		15,183		—		—
Finance income		42		66		100
Other income:
Net foreign exchange gain		—		5		—
Payroll tax rebate		2		2		—
Reimbursement of expenses		—		—		25
Research and development rebate		—		968		1,431
Subsidies and grants		—		20		9
Total revenue and other income		15,227		1,061		1,565

Fiscal 2021 compared to fiscal 2020

Revenue, finance income and other income

In fiscal 2021, the Company generated revenue from contracts with customers, being up-front license fees from the licensing of their two key assets to third parties. Revenue in fiscal 2021 amounted to A$15.2 million compared with nil in fiscal 2020.

The Company earns interest income derived from interest bearing bank account, which is directly linked with the amounts held on deposit. The amount of finance income earned decreased as a result of decreased cash balances as well as lower interest rates enjoyed during the year.

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Research and development rebate decreased from A$1.0 million in fiscal 2020 to nil in fiscal 2021. In fiscal 2021, the amount of qualifying expenditure in Australia was not sufficiently large to warrant making a claim for the R&D rebate, and we do not anticipate applying for the rebate in future fiscal years as this trend is set to continue.

Expenses

Research and development expenses increased from A$9.5 million in fiscal 2020 to A$14.5 million in fiscal 2021 (53%). The increase was mainly as a result of the Company’s lead asset, paxalisib, entering into a registrational trial run by GCAR, which aims to recruit up to 200 patients. Funds were also spent on preparatory work for the Phase I trial for EVT801, which is anticipated to open later in 2021.

General and administrative costs increased from A$3.7 million in fiscal 2020 to A$7.0 million in fiscal 2021 (89%). A total of A$1.5 million represented VAT and withholding tax on revenue deducted at source, and the Company also incurred additional costs in legal fees to support the three license transactions concluded during the year. This is the first year that the Company has held significant balances in currencies other than A$, and a small FX loss was experienced on translation of year end balances. Corporate overheads were also increased as the Company somewhat expanded its operating base, however there is a continued focus on conserving funds.

Net loss

The Company’s loss after income tax reduced from A$12.5 million in fiscal 2020 to A$8.4 million in fiscal 2021. The change was mainly as a result increased R&D expenditure during the fiscal 2021 as described above, offset somewhat by the revenue from license transactions, also as described above.

Fiscal 2020 compared to fiscal 2019

This analysis can be found in Item 5 of the Company’s annual report on Form 20-F for fiscal 2020.

B. Liquidity and capital resources

We have incurred cumulative losses and negative cash flows from operations since our inception and, as of June 30, 2021, we had accumulated losses of A$44.2 million. We anticipate that we will continue to incur losses for at least the next several years. We expect that our research and development expenditure will continue to increase and, as a result, we will need additional capital to fund our operations, which we may raise through a combination of equity offerings, other third-party funding, and other collaborations, strategic alliances and licensing arrangements.

We had no borrowings in fiscal 2021 and do not currently have a credit facility.

As of June 30, 2021, we had cash and cash equivalents of A$27.6 million, held in both A$ and US$. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation. Currently, our cash and cash equivalents are held in bank accounts. Our short-term investments consist of term deposits with maturity within 90 days. At June 30, 2021, term deposits amounting to A$6.5 million had a weighted average interest rate of 0.04%.

We expect to consume cash and incur operating losses for the foreseeable future as the Company continues developing its oncology drug candidates. The impact on cash resources and results from operations will vary with the extent and timing of the future clinical trial programs. The financial statements have been prepared on a going concern basis, which contemplates continuity of normal activities and realization of assets and settlement of liabilities in the normal course of business. As is often the case with drug development companies, the Company’s ability to continue its development activities as a going concern is dependent upon it deriving sufficient cash from investors, from licensing and partnering activities and from other sources of revenue such as grant funding. The directors have considered the cash flow forecasts and the funding requirements of the business and are confident that the strategies in place are appropriate to generate sufficient funding to allow us to continue as a going concern.

Cash flows

The following table set forth the sources and uses of cash for the past three fiscal years:

(in A$ thousands)	2021			2020			2019
Net cash used in operating activities		(9,110	)		(8,809	)		(6,714	)
Net cash from investing activities		—			—			2,359
Net cash from financing activities		28,108			12,139			3,815

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Operating activities. Net cash used in operating activities for the three fiscal years primarily represents net outflows for the cost of the R&D programs and the general and administrative costs of running the business. This amount is heavily impacted by the cost of the clinical programs, as well as cost containment measures adopted to manage the general and administrative costs of the business.

Investing activities. Net cash from investing activities in fiscal 2019 represents funds generated from the sale of shares in a listed entity, which were obtained via the settlement of an IP dispute.

Financing activities. Net cash from financing activities in fiscal 2021, 2020 and 2019 arose as a result of private placements of ordinary shares to institutional investors in certain countries as well as Share Purchase Plans to shareholders in Australia.

At June 30, 2021, the Company did not hold any derivative financial instruments for managing its foreign currency; however, the Company may from time to time enter into hedging arrangements where circumstances are deemed appropriate.

The Company believes that its future ability to fund its operations will depend on deriving sufficient cash from investors through successful capital raisings, from licensing and partnering activities and government grants.

The Company had no commitments for capital expenditure or material contractual obligations at the end of fiscal 2021.

The Company continuously pursues opportunities for non-dilutive funding, such as grant applications.

The Company cannot provide assurance that it or its subsidiaries will be able to raise the funds necessary to complete the planned clinical trial programs or find appropriate collaboration or licensing opportunities.

The Company does not have any off-balance sheet arrangements.

Financing activities

Equity issues

The Company has historically financed its operations primarily from issuing equity capital.

During fiscal 2019 the Company issued 13,757,052 ordinary shares. The details of these share issues are as follows:

• In October 2018 the Company issued 8,900,001 shares to industry funds and other investors and raised A$3,382,000 before costs.

• In November 2018, the Company issued 2,820,824 shares in relation to a milestone associated with the acquisition of Glioblast Pty Limited.

• In November 2018 the Company issued 2,036,227 shares to qualifying existing shareholders under the Company’s Share Purchase Plan, raising funds of A$773,760 before costs.

During fiscal 2020 the Company issued 32,431,696 ordinary shares. The details of these share issues are as follows:

• In November 2019, the Company issued 10,000,000 shares to industry funds and other investors and raised A$4,000,000 before costs.

• In April 2020, the Company issued 18,041,667 shares to industry funds and other investors and raised A$7,216,667 before costs.

• In May 2020 the Company issued 4,390,010 shares to qualifying existing shareholders under the Company’s Share Purchase Plan, raising funds of A$1,756,004 before costs.

During fiscal 2021 the Company issued 37,413,840 ordinary shares. The details of those share issues are as follows:

• In October 2020 the Company issued 31,542,895 shares to industry funds and other investors and raised A$25,234,316 before costs.

• In April 2021 the Company issued 3,037,580 shares to a partner pharmaceutical company for the sum of US$4,000,000.

• In May 2021 the Company issued 2,391,865 shares in satisfaction of a milestone payment relating to the acquisition of paxalisib.

• In August 2020 and March 2021, the Company issued a total of 441,500 shares upon the exercise of options, raising a total of A$273,287.

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Foreign currency fluctuations were not material for the Company in fiscal 2020 however as the Company held balances in US$ during fiscal 2021, a conversion loss of A$0.4 million was experienced in fiscal 2021. See Item 18. “Financial Statements – Note 21 – Financial Instruments” for disclosures about financial risk management including interest rate risk, foreign currency risk and liquidity risk.

Convertible note (Triaxial) carrying value of A$464,000

During the year ended June 30, 2013 the Company issued Convertible Notes with a face value of A$1,500,000 to Triaxial in consideration of the acquisition of patents and intellectual property assets. The terms of these Convertible Notes were amended on December 4, 2014. The amended terms allow the conversion of debt into ordinary shares, provided that the Company achieves certain milestones. Accordingly, the Convertible Note has been reclassified as an equity instrument rather than debt instrument.

During fiscal 2017, Kazia reached two milestones that triggered the conversion of a portion of its Convertible Notes. On September 14, 2016 the directors approved the issue of 20,000,000 ordinary shares as a consequence of a conversion of A$500,000 of the Convertible Notes, and on November 1, 2016 a further 16,000,000 ordinary shares were issued as a result of the conversion of a further portion of the Convertible Notes. During fiscal 2018, one of the noteholders waived his rights to the remaining tranche of convertible notes, resulting in the reduction of the convertible note carrying value by a further A$136,000. As of June 30, 2021, the Convertible Notes carrying value amounts to A$464,000.

C. Research and development, Patents and Licenses, etc.

Expenditure during the research phase of a project is recognized as an expense when incurred. Development costs are capitalized only when technical feasibility studies identify that the project will deliver future economic benefits and these benefits can be measured reliably.

Research and development expenses consist primarily of costs incurred for the development of our product candidates, which include:

• expenses incurred under agreements with academic research centres, clinical research organizations and investigative sites that conduct our clinical trials; and

• the cost of acquiring, developing, and manufacturing clinical trial materials.

We cannot determine with certainty the duration and completion costs of the current or future product development, preclinical studies or clinical trials of our product candidates. The duration, costs, and timing of clinical trials and development of our product candidates will depend on a variety of factors, including:

• the scope, rate of progress, and expense of our ongoing as well as any additional clinical trials and other research and development activities;

• the countries in which trials are conducted;

• future clinical trial results;

• uncertainties in clinical trial enrolment rates or drop-out or discontinuation rates of patients;

• potential additional safety monitoring or other studies requested by regulatory agencies;

• significant and changing government regulation; and

• the timing and receipt of any regulatory approvals.

A change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and timing associated with the development of that product candidate. For example, if the FDA, or another regulatory authority were to require us to conduct clinical trials beyond those that we anticipate will be required to complete clinical development of a product candidate or if we experience significant delays in enrollment in any of our clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development.

In fiscal 2021, 2020 and 2019 we spent, respectively, a total of A$14.5 million, A$9.5 million and A$6.5 million on company-sponsored research and development activities. We plan to increase our research and development expenses for the foreseeable future as we continue the development of product candidates and explore further potential applications of our technology.

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D. Trend Information

Further to the risk factors discussed in Item 3D, we note that the financial information disclosed in the SEC Form 20-F may not be indicative of future results in the following areas:

• While we anticipate that funds will continue to be spent on research and development of our drug candidates, the amounts expended in recent years may not be indicative of the amounts to be expended in future years, because we may have more or fewer drug candidates, they may be at different stages of their lifecycle and the trials deemed suitable for their development may be more or less costly;

• While we generated revenue from licensing transactions in fiscal 2021, Kazia may not generate any revenue in future years, and if it does, the amounts generated in fiscal 2021 may not be representative of any such revenues in future years. This could be as a result of whether any further licensing transactions are entered into, as well as whether any milestones are met in relation to license agreements already in place;

• The quantum of general and administrative expenditure in recent years may not be indicative of the expenditure required in future years;

E. Critical Accounting Estimates – see Note 2. Significant accounting policies

Item 6. Directors, Senior Management and Employees

A. Directors and Senior Management

The names and details of the Company’s Directors and senior management at the date of this report are as follows:

Iain Ross	Chairman, Non-Executive Director
Bryce Carmine	Non-Executive Director
Steven Coffey	Non-Executive Director
James Garner	Managing Director and Chief Executive Officer
Kate Hill	Company Secretary
Gabrielle Heaton	Director of Finance and Administration

Directors were in office for the entire period unless otherwise stated.

Names, titles, experience and expertise

Name:	Iain Ross
Title:	Chairman, Non-Executive Director
Experience and expertise:	Iain, based in the UK, is an experienced Director and has served on a number of Australian company boards. He is Chairman of Silence Therapeutics plc (LSE & NASDAQ:SLN), ReNeuron Group plc (LSE:RENE) and BiVitctriX Therapeutics plc (LSE:BVX) as well as unlisted Biomer Technology Limited. He is also a non-executive director of Palla Pharma Limited (ASX:PAL). In his career he has held senior positions in Sandoz AG, Fisons Plc, Hoffmann-La Roche AG and Celltech Group Plc and also undertaken a number of start-ups and turnarounds on behalf of banks and private equity groups. His track record includes multiple financing transactions having raised in excess of £400 million, both publicly and privately, as well as extensive experience of divestments and strategic restructurings and has over 25 years in cross-border management as a Chairman and CEO. He has led and participated in 8 Initial Public Offerings,(5 LSE, 1 ASX, 2 NASDAQ) and has direct experience of mergers and acquisitions transactions in Europe, USA and the Pacific Rim.
Other current directorships:	Silence Therapeutics plc (LSE:SLN), ReNeuron Group plc (LSE:RENE), Palla Pharma Limited (ASX:PAL) and BiVictriX Therapeutics plc (LSE:BVX)
Special responsibilities:	Member of Remuneration and Nomination Committee, Member of the Audit, Risk and Governance Committee.

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Name:	Bryce Carmine
Title:	Non-Executive Director
Experience and expertise:	Bryce spent 36 years working for Eli Lilly & Co. and retired as Executive Vice President for Eli Lilly & Co, and President, Lilly Bio-Medicines. Prior to this he led the Global Pharmaceutical Sales and Marketing and was a member of the Company’s Executive Committee. Bryce previously held a series of product development portfolio leadership roles culminating when he was named President, Global Pharmaceutical Product Development, with responsibility for the entire late-phase pipeline development across all therapeutic areas for Eli Lilly. During his career with Lilly, Bryce held several country leadership positions including President Eli Lilly Japan, Managing Dir. Australia/NZ & General Manager of a JV for Lilly in Seoul, Korea. Bryce is currently Chairman and CEO of HaemaLogiX Pty Ltd, a Sydney based privately owned biotech.
Other current directorships:	None
Special responsibilities:	Chair of Remuneration and Nomination Committee, member of Audit, Risk and Governance Committee.
Name:	Steven Coffey
Title:	Non-Executive Director
Experience and expertise:	Steven is a Chartered Accountant and registered company auditor and has over 35 years experience in the accounting and finance industry. He has been a partner in the chartered accounting firm Watkins Coffey Martin since 1993. Steven sits on the board of a number of large private family companies and audits a number of large private companies and not-for-profit entities.
Other current directorships:	none
Special responsibilities:	Chair of Audit, Risk and Governance Committee, member of Remuneration and Nomination Committee.
Name:	Dr. James Garner
Title:	Managing Director and Chief Executive Officer
Experience and expertise:	Dr Garner is an experienced life sciences executive who has previously worked with companies ranging from small biotechs to multinational pharmaceutical companies such as Biogen and Takeda. His career has focused on regional and global development of new medicines from preclinical to commercialisation. Dr Garner is a physician by training and holds an MBA from the University of Queensland. He began his career in hospital medicine and worked for a number of years as a corporate strategy consultant with Bain & Company before entering the pharmaceutical industry. Prior to joining Kazia in 2016, he led R&D strategy for Sanofi in Asia-Pacific and was based in Singapore.
Other current directorships:	None
Special responsibilities:	None
Name:	Kate Hill
Title:	Company Secretary
Experience and expertise:	Kate has over 20 years’ experience as an audit partner with Deloitte Touche Tohmatsu, working with ASX listed and privately-owned clients. She has worked extensively in regulated environments including assisting with Initial Public Offerings, capital raising and general compliance, as well as operating in an audit environment. She is a Non-Executive Director of CountPlus Limited (ASX:CUP) and Elmo Software Limited (ASX:ELO) as well as Chair of the Audit and Risk Committee for both of these companies. She is also Chair of Seeing Machines Limited (LSE:SEE). Kate is a member of the Institute of Chartered Accountants in Australia and New Zealand, and a graduate of the Australian Institute of Company Directors.
Name:	Gabrielle Heaton
Title:	Director of Finance and Administration
Experience and expertise:	Gabrielle Heaton has over 30 years of commercial experience in media, property services and healthcare for multinational, ASX listed and overseas companies. She has held a number of senior Finance positions including CFO, Quality Auditor and been responsible for Human Resources and IT. Gabrielle has a Bachelor of Business from the University of Technology and is a member of CPA Australia.

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B. Compensation

Principles used to determine the nature and amount of remuneration

Remuneration philosophy

Remuneration for Directors and Senior Executives is based on the overall objective of attracting and retaining people of high quality who will make a worthwhile contribution to Kazia in the short, medium and long term, and thereby contribute to long term shareholder value. The Board and its Remuneration and Nomination Committee take a balanced position between the need to pay market rates to attract talent, and the financial resources of Kazia, in determining remuneration.

Non-Executive Directors remuneration

The Constitution of Kazia and the ASX listing rules specify that the aggregate remuneration of Non-Executive Directors shall be determined from time to time by General Meeting. The last determination for Kazia was at the Annual General Meeting held in November 2020 when the shareholders approved an aggregate remuneration of A$700,000.

Non-Executive Directors’ fees are reviewed periodically by the Board and are regularly compared with those of companies of comparable market capitalisation and stage of development. The Chairman’s fees are determined independently to the fees of other non-executive Directors based on comparative roles in the external market.

Fees paid to director were relatively constant in recent years as a result of funding constraints, and in the current financial year, after conducting a benchmarking exercise, directors fees were increased to a market rate, and a bonus was paid to Non-Executive Directors to reflect their service over recent years at a discounted remuneration level. Further, at the 2020 AGM the shareholders approved the award of 400,000 options to each Non-Executive Director.

In relation to the cap on aggregate fees of Non-Executive Directors, the value of the options has been excluded from the calculation of aggregate fees because the options were separately approved by the shareholders.

The Non-Executive Directors fee structure is a fixed fee model and includes superannuation.

Executive Directors and other Key Management Personnel (“KMP”)

The Board and the Remuneration and Nomination Committee, in consultation with the Managing Director, have put in place a remuneration structure which provides incentive for employees to drive the activities of the company forward. These arrangements are reviewed annually at the end of the calendar year.

The Board determines an appropriate level of fixed remuneration for the CEO and Group Executives, as well as the proportion of performance-based remuneration.

The executive remuneration and reward framework has three components:

• fixed remuneration

• short-term performance incentives - cash bonus

• share-based payments - award of options through the ESOP

Fixed remuneration is reviewed annually by the Remuneration and Nomination Committee based on individual performance, the overall performance of Kazia and comparable market remunerations. The Remuneration and Nomination Committee approved increases in fixed remuneration during fiscal 2021.

The short-term incentives program is designed to align the targets of Kazia with the performance hurdles of executives. Short-term incentive payments are granted to executives based on specific annual performance objectives, metrics and performance appraisals. Annual performance reviews are conducted at the end of each calendar year and bonuses are paid shortly after the performance reviews are completed. Annual performance objectives cover matters such as progress in clinical trials, and management of the Company’s financial resources.

The Board or the Remuneration and Nomination Committee may, at its discretion, award bonuses for exceptional performance.

The Remuneration and Nomination Committee approved the payment of cash bonuses to the CEO and employees in respect of the financial year ended June 30, 2020. The approval with respect to the financial year ended June 30, 2021, is expected to occur subsequent to the filing of this annual report.

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The long-term incentive comprises equity-based payments. Kazia aims to attract and retain high calibre executives, and align their interests with those of the shareholders, by granting equity-based payments based on tenure. The share-options issued to executives are governed by the ESOP.

Employee share option plan

The Employee Share Option Plan (‘ESOP’) was most recently approved by shareholders in November 2020.

The ESOP provides for the issue of options to eligible individuals, being employees, Officers and Non-executive directors of Kazia.

Each option issued under the ESOP entitles its holder to acquire one fully paid ordinary share and is exercisable at a price based on a formula, which includes the weighted average price of such shares at the close of trading on the Australian Securities Exchange for the seven days prior to the date of issue. The number of options offered, the amount payable, the vesting period, the option period, the conditions of exercise or any other factors are at the discretion of the Board of Directors.

Kazia issued 2,200,000 share options under the ESOP during fiscal 2021, of which 2,100,000 were issued to Key Management Personnel.

Any change to the ESOP will require approval by shareholders.

Use of remuneration consultants

During fiscal 2021, the Company did not engage remuneration consultants to assist with the determination of remuneration levels.

Details of remuneration

Amounts of remuneration

Details of the remuneration of key management personnel of Kazia are set out in the following tables.

The KMP of Kazia consisted of the following directors of Kazia Therapeutics Limited:

• Iain Ross - Non-Executive Director, Chairman

• Bryce Carmine - Non-Executive Director

• Steven Coffey - Non-Executive Director

• Dr James Garner - Managing Director, CEO

And the following persons:

• Gabrielle Heaton - Director of Finance and Administration

• Kate Hill - Company Secretary

	Short-term benefits				Short-term benefits			Post- employment benefits		Share-based payments
					Movements in accrued leave
	Cash salary		Cash		Non-			Super-		Equity-
	and fees		Bonus		monetary			annuation		settled options		Total
2021	A$		A$		A$			A$		A$		A$
Non-Executive Directors:
I Ross*		147,436		20,000		—			—		119,067		286,503
B Carmine		82,500		22,500		—			9,975		119,067		234,042
S Coffey		82,500		22,500		—			9,975		119,067		234,042
Executive Directors:
J Garner		503,000		240,000		90,400			70,585		228,651		1,132,636
Other Key Management Personnel:
G Heaton		204,000		25,000		(241	)		21,755		15,069		265,583
K Hill		108,525		26,400		—			—		15,677		155,701
		1,127,961		356,400		90,159			112,290		616,598		2,303,408

* Salary paid in UK pounds, but disclosed in Australian dollars using an annual average rate of 0.5562

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The cash bonuses were granted by the Remuneration Committee at a meeting held in December 2020. The amounts were determined on a discretionary basis by the Remuneration Committee after assessing the corporate achievements for fiscal 2020.

Service agreements

Under Remuneration and Nomination Committee policy, employment contracts are entered into with each of the executives who is considered to be KMP. Under the terms of the contracts, remuneration is reviewed at least annually. The employment contracts of KMPs include a termination clause whereby a party can terminate the agreement on notice. Such notice may vary between 4 weeks and 6 months. Under the terms of each contract, payment in lieu can be made by Kazia to substitute the notice period. Kazia may terminate the contracts at any time without cause if serious misconduct has occurred. In the event that employment is terminated for cause, no severance pay or other benefits are payable by Kazia.

Remuneration and other terms of employment for key management personnel are formalised in service agreements. Details of these agreements are as follows:

Name: Title: Agreement commenced: Term of agreement: Details:	James Garner Chief Executive Officer, Managing Director February 1, 2016 Full-time employment Base salary to be reviewed annually by the Remuneration and Nomination Committee. James’s appointment with Kazia may be terminated with Kazia giving 6 months’ notice or by James giving 6 months’ notice. Kazia may elect to pay James equal amount to that proportion of his salary equivalent 6 months’ pay in lieu of notice, together with any outstanding entitlements due to him.
	The current base salary, as from January 1, 2021, is A$510,000 including an allowance for health benefits.
Name: Title: Agreement commenced: Term of agreement: Details:	Gabrielle Heaton Director of Finance and Administration March 13, 2017 Full time employment Base salary to be reviewed annually by the Remuneration and Nomination Committee. Gabrielle’s appointment with Kazia may be terminated with Kazia giving 4 weeks’ notice or by Gabrielle giving 4 weeks’ notice. Kazia may elect to pay Gabrielle equal amount to that proportion of her salary equivalent 4 weeks’ pay in lieu of notice, together with any outstanding entitlements due to her.
	The current base salary, from January 1, 2021, is A$208,000.
Name: Title: Agreement commenced: Term of agreement: Details:	Kate Hill Company Secretary September 9, 2016 Part-time contractor Base remuneration is based on time worked. Daily rate to be reviewed annually by the Remuneration and Nomination Committee, with monthly rate of A$11,900 for a two-day week, applied from January 1, 2021. The contract is open ended. Kate’s appointment with Kazia may be terminated with Kazia giving 60 days’ notice or by Kate giving 60 days’ notice.

Key management personnel have no entitlement to termination payments in the event of removal for misconduct.

Share-based compensation

Issue of shares

The terms and conditions of each grant of options over ordinary shares granted as remuneration to Directors or other Key Management Personnel in this financial year or future financial years are set out below.

The options issued in November 2020 were to James Garner (800,000 options with a fair value at grant date of $402,000), Iain Ross (400,000 options with a fair value at grant date of $165,300), Bryce Carmine (400,000 options with a fair value at grant date of $165,300) and Steven Coffey (400,000 options with a fair value at grant date of $165,300)

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The options issued in January 2021 were to Kate Hill (50,000 options, with a fair value at grant date of $29,929) and Gabrielle Heaton (50,000 options, with a fair value at grant date of $29,929). Service conditions are that any unvested options are forfeit on cessation of employment. There are no performance conditions, consistent with the Company’s Employee Share Option Plan rules, as reapproved by shareholders in November 2020.

Options issued during the financial year

Grant date	No of options		Vesting date		Expiry date		Exercise price $		Fair value at grant date $
09/11/2020		200,000		13/01/2021		13/01/2025	$	0.881	$	0.450
09/11/2020		200,000		13/01/2022		13/01/2025	$	0.881	$	0.490
09/11/2020		200,000		13/01/2023		13/01/2025	$	0.881	$	0.520
09/11/2020		200,000		13/01/2024		13/01/2025	$	0.881	$	0.550
09/11/2020		300,000		01/01/2021		09/11/2024	$	1.132	$	0.379
09/11/2020		300,000		01/07/2021		09/11/2024	$	1.132	$	0.403
09/11/2020		300,000		01/01/2022		09/11/2024	$	1.132	$	0.425
09/11/2020		300,000		01/07/2022		09/11/2024	$	1.132	$	0.446
04/01/2021		25,000		04/01/2022		04/01/2025	$	1.690	$	0.520
04/01/2021		25,000		04/01/2023		04/01/2025	$	1.690	$	0.576
04/01/2021		25,000		04/01/2024		04/01/2025	$	1.690	$	0.627
04/01/2021		25,000		04/01/2025		04/01/2025	$	1.690	$	0.671
		2,100,000

Options granted carry no dividend or voting rights. Each option is convertible to one ordinary share upon exercise. During the year, 96,500 options were exercised by Gabrielle Heaton and 245,000 options were exercised by Kate Hill.

Pension benefits

The Company paid A$112,290 during fiscal 2021 for employee superannuation benefits and pension benefits related to KMPs.

C. Board Practices

The role of the Board is as follows:

• representing and serving the interests of shareholders by overseeing and appraising the strategies, policies and performance of the Company. This includes overviewing the financial and human resources the Company has in place to meet its objectives and the review of management performance;

• protecting and optimising Company performance and building sustainable value for shareholders in accordance with any duties and obligations imposed on the Board by law and the Company’s Constitution and within a framework of prudent and effective controls that enable risk to be assessed and managed;

• responsible for the overall Corporate Governance of Kazia Therapeutics Limited and its subsidiaries, including monitoring the strategic direction of the Company and those entities, formulating goals for management and monitoring the achievement of those goals;

• setting, reviewing and ensuring compliance with the Company’s values (including the establishment and observance of high ethical standards); and

• ensuring shareholders are kept informed of the Company’s performance and major developments affecting its state of affairs.

Responsibilities/functions of the Board include:

• selecting, appointing and evaluating from time to time the performance of, determining the remuneration of, and planning for the successor of, the CEO;

• reviewing procedures in place for appointment of senior management and monitoring of its performance, and for succession planning. This includes ratifying the appointment and the removal of the Company Secretary;

• overseeing the Company, including its control and accountability systems;

• input into and final approval of management development of corporate strategy, including setting performance objectives and approving operating budgets;

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• reviewing and guiding systems of risk management and internal control and ethical and legal compliance. This includes reviewing procedures in place to identify the main risks associated with the Company’s businesses and the implementation of appropriate systems to manage these risks;

• overseeing and monitoring compliance with the Code of Conduct and other corporate governance policies;

• monitoring corporate performance and implementation of strategy and policy;

• approving major capital expenditure, acquisitions and divestitures, and monitoring capital management;

• monitoring and reviewing management processes in place aimed at ensuring the integrity of financial and other reporting;

• monitoring and reviewing policies and processes in place relating to occupational health and safety, compliance with laws, and the maintenance of high ethical standards; and

• performing such other functions as are prescribed by law or are assigned to the Board.

In carrying out its responsibilities and functions, the Board may delegate any of its powers to a Board committee, a director, employee or other person subject to ultimate responsibility of the directors under the Australian Corporations Act 2001.

Matters which are specifically reserved for the Board or its committees include the following:

• appointment of a Chair;

• appointment and removal of the CEO;

• appointment of directors to fill a vacancy or as additional directors;

• establishment of Board committees, their membership and delegated authorities;

• approval of dividends;

• development and review of corporate governance principles and policies;

• approval of major capital expenditure, acquisitions and divestitures in excess of authority levels delegated to management;

• calling of meetings of shareholders; and

• any other specific matters nominated by the Board from time to time.

Structure of the Board

The Company’s Constitution governs the regulation of meetings and proceedings of the Board. The Board determines its size and composition, subject to the terms of the Constitution. The Board does not believe that it should establish a limit on tenure other than stipulated in the Company Constitution (refer to ‘Term of Directors’ below).

While tenure limits can help to ensure that there are fresh ideas and viewpoints available to the Board, they hold the disadvantage of losing the contribution of directors who have been able to develop, over a period of time, increasing insight in the Company and its operation and, therefore, an increasing contribution to the Board as a whole. It is intended that the Board should comprise a majority of independent non-executive directors and comprise directors with a broad range of skills, expertise and experience from a diverse range of backgrounds. The Board regularly reviews the independence of each director in light of the interests disclosed to the Board.

The Board only considers directors to be independent where they are independent of management and free of any business or other relationship that could materially interfere with, or could reasonably be perceived to interfere with, the exercise of their unfettered and independent judgment. The Board has adopted a definition of independence based on that set out in Principle 2.3 of the ASX Corporate Governance Principles and Recommendations (4th edition). The Board will review the independence of each director in light of interests disclosed to the Board from time to time. In accordance with the definition of independence above, and the materiality thresholds set, the Board considers Bryce Carmine, Iain Ross and Steven Coffey to be independent directors.

There are procedures in place, agreed by the Board, to enable directors in furtherance of their duties to seek independent professional advice at the Company’s expense. The appointment and expiration dates of each director in office at the date of this report is as follows:

Name	Position	Year First Appointed	Current term expires
Bryce Carmine	Non-executive Director	2015	Nov-23
Iain Ross	Non-executive Director, Chairman	2014	Nov-21
Steven Coffey	Non-executive Director	2012	Nov-22
James Garner	Managing Director, CEO	2016	N/A*

* The managing director is exempt from standing for re-election under the Company’s constitution and Australian corporate law.

Further details on each director can be found in “Names, titles, experience and expertise” above.

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Term of Directors

The Company’s Constitution requires that at each Annual General Meeting of the Company, one third (or the number nearest to but not exceeding one third) of the directors, (excluding a director who is the Managing Director, and a director appointed to fill a casual vacancy) must retire from office provided that no director may retain office for more than three years without offering himself/herself for re-election even though such submission results in more than one third of the directors retiring from office.

The Board of Directors has the power to appoint any person to be a director either to fill a casual vacancy or as an additional director (up to a maximum of 10). Any director so appointed may hold office only until the next Annual General Meeting when he or she shall be eligible for election by the Company shareholders.

Board of Directors

The Board of Kazia Limited is elected by and accountable to shareholders. The Board monitors and directs the business and is responsible for the corporate governance of the Company. As at June 30, 2021, the Board comprised of four directors, three of whom were non-executive directors.

We do not have a ‘diverse’ board of directors as defined in Nasdaq Rule 5605(f). Kazia is a small company with four Directors. All of our Directors have been with the Company more than five years so there has not been an opportunity to consider ‘diverse’ candidates. That being said, we believe in having a diverse workforce and will consider ‘diverse’ director candidates when an opportunity arises.

Committees

The Board has established an Audit, Risk and Governance Committee and a Remuneration and Nomination Committee.

Audit, Risk and Governance Committee

The Board has established an Audit, Risk and Governance Committee which operates under a Charter approved by the Board, which is available on the Company’s website. It is the Board’s responsibility to ensure that an effective internal control framework exists within the entity. This includes internal controls to deal with both the effectiveness and efficiency of significant business processes, the safeguarding of assets, the maintenance of proper accounting records, and the reliability of financial information as well as non-financial considerations such as the benchmarking of operational key performance indicators. The Board has delegated responsibility for establishing and maintaining a framework of internal control and ethical standards to the Audit, Risk and Governance Committee.

The Committee also provides the Board with additional assurance regarding the reliability of financial information for inclusion in the financial reports.

Members of the Audit, Risk and Governance Committee are Steven Coffey (Chairman), Bryce Carmine and Iain Ross, each of whom is an independent director.

Remuneration and Nomination Committee

The purpose of the Remuneration and Nomination Committee is to assist and advise the Board to develop, implement and, from time to time, update policies in relation to:

• the selection, nomination and appointment processes for directors; and

• the remuneration of key management personnel and directors.

This committee is accountable to the Board for its performance and is subject to an annual review by the Board. Members of the Remuneration and Nomination Committee are Bryce Carmine (Chairman), Steven Coffey and Iain Ross, each of whom is an independent director.

Performance

The performance of the Board and key executives is reviewed regularly using both measurable and qualitative indicators.

On at least a bi-annual basis, directors will provide written feedback in relation to the performance of the Board and its Committees against a set of agreed criteria:

• each Committee of the Board will also be required to provide feedback in terms of a review of its own performance;

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• feedback will be collected by the chair of the Board, or an external facilitator, and discussed by the Board, with consideration being given as to whether any steps should be taken to improve performance of the Board or its Committees;

• the Chief Executive Officer will also provide feedback from senior management in connection with any issues that may be relevant in the context of Board performance review; and

• where appropriate to facilitate the review process, assistance may be obtained from third party advisors.

Remuneration

It is the Company’s objective to provide maximum shareholder benefit from the retention of a high-quality Board and executive team by remunerating directors and key executives fairly and appropriately with reference to relevant employment market conditions. To assist in achieving this objective, the Board, in assuming the responsibilities of assessing remuneration to employees, links the nature and amount of executive directors’ and officers’ remuneration to the Company and Company’s financial and operational performance.

The expected outcomes of the remuneration structure are:

• retention and motivation of key executives;

• attraction of high-quality management to the Company and Company; and

• performance incentives that allow executives to share in the success of Kazia Therapeutics Limited.

For a more comprehensive explanation of the Company’s remuneration framework and the remuneration received by directors and key executives in the current period, please refer to the section “Compensation” above.

There is no plan to provide retirement benefits to executive or non-executive directors, except for the Australian Government Superannuation Guarantee.

The Remuneration and Nomination Committee is responsible for determining and reviewing compensation arrangements for the directors themselves and the Chief Executive Officer and executive team.

D. Employees

As of the end of each of the last three fiscal years, the Company employed the following number of people - FTEs:

Category of Activity	2021		2020		2019
Research and Development		4.6		3.6		3.6
Finance and Administration		1.7		1.7		1.7
Total		6.3		5.3		5.3
Geographic Location	2021		2020		2019
Australia		5.3		5.3		5.3
United States		1		0		0
Total		6.3		5.3		5.3

E. Share Ownership

Directors’ and KMP interests in the shares and options of the Company for fiscal 2021:

Shareholding

The number of shares in the Company held during fiscal 2021 by each Director and other members of Key Management Personnel of the Company, including their personally related parties, is set out below:

	Balance at start of year		Received as part of rem		Additions		Disposals		Balance at end of year
Ordinary shares
B Carmine*		266,293		—		106,400		—		372,693
S Coffey*		326,474		—		107,791		—		434,265
J Garner*		275,000		—		155,000		—		430,000
I Ross*		800,001		—		200,000		—		1,000,001
K Hill*		30,000		—		265,000		—		295,000
G Heaton*		10,000		—		103,168		—		113,168
Total		1,707,768		—		937,359		—		2,645,127

* Each Director and Key Management Personnel owns less than 1% of shareholding.

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Option holding

The number of options over ordinary shares in the company held during the financial year by each Director and other members of Key Management Personnel of Kazia, including their personally related parties, is set out below:

	Balance at the start of the year		Granted as remuneration		Expired		Exercised			Balance at the end of the year
Options over ordinary shares
J Garner*		1,200,000		800,000		—		—			2,000,000
K Hill*		320,000		50,000		—		(245,000	)		125,000
G Heaton*		242,000		50,000		—		(96,500	)		195,500
Iain Ross*		—		400,000		—		—			400,000
Bryce Carmine*		—		400,000		—		—			400,000
Steven Coffey*		—		400,000		—		—			400,000
		1,762,000		2,100,000		—		(341,500	)		3,520,500

* Options issued under the Employee Share Option Plan. Unvested options are forfeited upon cessation of employment with the Company.

Share-based compensation

There were no shares issued to Directors or other KMP as part of compensation during fiscal 2021.

Item 7. Major Shareholders and Related Party Transactions

A. Major shareholders

The following table present certain information regarding the beneficial ownership of our ordinary shares based on 132,012,209 ordinary shares outstanding at September 30, 2021, by each person known by us to be the beneficial owner of more than 5% of our ordinary shares, as well as their holdings on October 14, 2020 and August 31, 2019.

	Ordinary shares beneficially owned
5% or greater shareholders	September 30, 2021					August 14, 2020					August 31, 2019
	Number		%			Number		%			Number		%
Hishenk Pty Limited and associated entities		18,715,000		14.44	%		18,570,000		16.1	%		11,108,792		17.9	%
Platinum International Healthcare Fund		7,084,856		5.47	%		11,356,760		9.9	%		6,578,948		10.6	%
Quest Asset Partners Pty Ltd		11,101,710		8.4	%		7,215,790		6.3	%		—		0.0	%

At September 30, 2021, there were 3,130,299 of the Company’s ADSs outstanding, representing 31,302,996 ordinary shares (or 27.1% of the then outstanding ordinary shares). At September 30, 2021, there were 52 registered holders of the Company’s ADSs. On that same date, 100 ordinary shares were held directly by U.S. holders.

There have been no other significant shareholders in the last three fiscal years. All shareholders have the same voting rights.

B. Related party transactions

During fiscal 2021, and up to the date of this report, we did not enter into any transactions or loans with any: (i) enterprises that directly or indirectly, through one or more intermediaries, control, are controlled by or are under common control with us; (ii) associates; (iii) individuals owning, directly or indirectly, an interest in our voting power that gives them significant influence over us, and close members of any such individual’s family; (iv) executive officers and close members of such individuals’ families; or (v) enterprises in which a substantial interest in our voting power is owned, directly or indirectly, by any person described in (iii) or (iv) or over which such person is able to exercise significant influence.

Transactions between related parties, when they occur, are on normal commercial terms and the conditions no more favorable than those available to other non-related parties.

C. Interests of Experts and Counsel

Not applicable

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Item 8. Financial Information

A. Consolidated Statements and Other Financial Information

Consolidated financial statements are included in Item 18. “Financial Statements” commencing on page F-1.

Legal proceedings

In prior periods, Kazia was prosecuting its Intellectual Property (‘IP’) rights against an Austrian company, APOtrend, and had provided a guarantee to the value of €250,000 with the court to provide security for potential damage claimes raised by APOtrend. During fiscal 2021 the proceedings were settled and the deposit was released in full back to Kazia.

Dividends

There were no dividends paid, recommended or declared during fiscal years 2021, 2020 or 2019.

B. Significant Changes

No significant change has occurred since the date of the annual financial statements included in this Annual Report on Form 20-F.

Item 9. The Offer and Listing

A. Offer and listing details

See Item 9C for more information.

B. Plan of Distribution

Not applicable

C. Markets

Kazia’s principal listing exchange and the exchange upon which its ordinary shares are quoted is the Australian Securities Exchange (“ASX”). The trading symbol on ASX is ‘KZA’.

Kazia’s ordinary shares trade in the U.S. in the form of ADSs on the NASDAQ Capital Market. Each ADS represents 10 ordinary shares of Kazia. The trading symbol on the NASDAQ Capital Market is ‘KZIA’. Kazia has entered into a Deposit Agreement with The Bank of New York Mellon under which the Bank of New York, acting as depositary, issues the ADSs.

D. Selling Shareholders

Not applicable

E. Dilution

Not applicable

F. Expenses of the issue

Not applicable

Item 10. Additional Information

A. Share Capital

Not applicable

B. Memorandum and Articles of Association

Our Constitution is similar in nature to the bylaws of a U.S. corporation. It does not provide for or prescribe any specific objectives or purposes of Kazia. Our Constitution is subject to the terms of the ASX Listing Rules and the Corporations Act. It may be amended or repealed and replaced by special resolution of shareholders, passed by at least 75% of the votes cast by shareholders entitled to vote on the resolution.

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Under Australian law, a company has the legal capacity and powers of an individual both within and outside Australia. The material provisions of our Constitution are summarized below. This summary is not intended to be complete nor to constitute a definitive statement of the rights and liabilities of our shareholders, and is qualified in its entirety by reference to the complete text of our Constitution, a copy of which is incorporated by reference as Exhibit 1.1 to this Annual Report.

Interested Directors

Subject to the Corporations Act and the ASX Listing Rules, neither a director nor that director’s alternate may vote in respect of any contract or arrangement in which the director has, directly or indirectly, any material interest according to our Constitution. However, that director may execute or otherwise act in respect of that contract or arrangement notwithstanding any material personal interest. Unless a relevant exception applies, the Corporations Act requires our directors to provide disclosure of any material personal interest, and prohibits directors from voting on matters in which they have a material personal interest or being present while such matter is being considered at the board meeting. In addition, the Corporations Act and the ASX Listing Rules require shareholder approval of any provision of related party benefits to our directors.

Directors compensation

Our directors are paid remuneration for their services as directors (but excluding any remuneration payable to a director under any executive services contract with us or one of our related bodies corporate) which is determined in a general meeting of shareholders. The aggregate, fixed sum for directors’ remuneration is to be divided among the directors in such proportion as the directors themselves agree and in accordance with our Constitution. The fixed sum remuneration for directors may not be increased except at a general meeting of shareholders and the particulars of the proposed increase are required to have been provided to shareholders in the notice convening the meeting. In addition, executive directors may be paid remuneration as determined by the directors from time to time and, subject to the ASX Listing Rules, including as a salary, commission or participation in profits and/or by the issue of shares, options to acquire shares or performance rights or other incentives (or a combination of any of these methods of remuneration).

Fees payable to our non-executive directors must be by way of a fixed sum and not by way of a commission on or a percentage of profits or operating revenue. Remuneration paid to our executive directors must also not include a commission or percentage of operating revenue.

Pursuant to our Constitution, if, at our board’s request, any director performs extra services or makes special exertions, Kazia may remunerate that director by paying for those services and exertions.

In addition to other remuneration provided in our Constitution, all of our directors are entitled to be paid by us for all other travelling, accommodation and other expenses incurred by the directors in attending and returning from general meetings, board meetings, committee meetings or otherwise in connection with our business.

Borrowing powers exercisable by Directors

Pursuant to our Constitution, the management and control of our business affairs are vested in our board of directors. Our board of directors has the power to raise or borrow money or obtain other financial accommodation for Company purposes, and may grant security for the repayment of that sum or sums or the payment, performance or fulfilment of any debts, liabilities, contracts or obligations incurred or undertaken by the Company in any manner and on any terms and conditions as our board thinks fit.

Retirement of Directors

Pursuant to our Constitution and the ASX Listing Rules, at least one director, other than the Managing Director, must retire from office at every annual general meeting unless there has been an election of directors earlier that year. A director, other than the director who is the Managing Director, must retire from office at the conclusion of three years or following the third annual general meeting after which the director was elected, whichever is longer. If no director is required to retire at an annual general meeting, then the director to retire will be the director who has been longest in office since last being elected. Retired directors are eligible for a re-election to the board of directors unless disqualified from acting as a director under the Corporations Act or our Constitution.

Rights and restrictions on classes of shares

The rights attaching to our ordinary shares are detailed in our Constitution. Our Constitution provides that our directors may issue shares with any preferential, deferred or special rights, privileges or conditions or with any restriction (whether in relation to dividends, voting, return of share capital or otherwise) as our board of directors may determine. Subject to any approval which is required from our shareholders under the Corporations Act and the ASX Listing Rules, we may issue further shares on such terms and conditions as our board of directors resolves.

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Dividend rights

Our board of directors may from time to time determine to pay and declare dividends to shareholders. All dividends unclaimed for one year after having been declared may be invested or otherwise made use of by our board of directors for our benefit until claimed or otherwise disposed of in accordance with our Constitution.

Voting rights

Under our Constitution, and subject to any voting exclusions imposed under the ASX Listing Rules (which typically exclude parties from voting on resolutions in which they have an interest), the rights and restrictions attaching to a class of shares, each shareholder has one vote on a show of hands at a meeting of the shareholders unless a poll is demanded under the Constitution or the Corporations Act. On a poll vote, each shareholder shall have one vote for each fully paid share and a fractional vote for each share held by that shareholder that is not fully paid, such fraction being equivalent to the proportion of the amount that has been paid to such date on that share. Shareholders may vote in person or by proxy, attorney or representative. Under Australian law, shareholders of a public company are generally not permitted to approve corporate matters by written consent. Our Constitution does not provide for cumulative voting. Note that ADS holders may not directly vote at a meeting of the shareholders but may instruct the depositary to vote the number of deposited ordinary shares their ADSs represent.

Right to share in our profits

Pursuant to our Constitution, our shareholders are entitled to participate in our profits only by payment of dividends. Our board of directors may from time to time determine to pay dividends to the shareholders; however, no dividend is payable except in accordance with the thresholds set out in the Corporations Act.

Rights to share in the surplus in the event of winding up

Our Constitution provides for the right of shareholders to participate in a surplus in the event of our winding up, subject to the rights attaching to a class of shares, the Constitution, the Corporations Act and the ASX Listing Rules.

No redemption provision for ordinary shares

There are no redemption provisions in our Constitution in relation to ordinary shares. Under our Constitution, any preference shares may be issued on the terms that they are, or may at the option of Kazia or the holder be, liable to be redeemed or converted into ordinary shares.

Variation or cancellation of share rights

Subject to the Corporations Act, the ASX Listing Rules and the terms of issue of shares of that class, the rights attached to shares in a class of shares may only be varied or cancelled by either:

• a special resolution passed at a meeting of members holding shares in that class; or

• the written consent of members with at least 75% of the shares in that class.

Directors may make calls

Our Constitution provides that our directors may make calls on a shareholder for all monies unpaid on shares held by that shareholder, other than monies payable at fixed times under the conditions of allotment.

General Meetings of Shareholders

General meetings of shareholders may be called by our board of directors. Except as permitted under the Corporations Act, shareholders may not convene a meeting. The Corporations Act requires the directors to call and arrange to hold a general meeting on the request of shareholders with at least 5% of the votes that may be cast at a general meeting. Notice of the proposed meeting of our shareholders is required at least 28 days prior to such meeting under the Corporations Act.

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Foreign Ownership Regulation

Our Constitution does not impose specific limitations on the rights of non-residents to own securities. However, acquisitions and proposed acquisitions of securities in Australian companies may be subject to review and approval by the Australian Federal Treasurer under the Foreign Acquisitions and Takeovers Act 1975 (Cth) (the “Foreign Takeovers Act”), which generally applies to acquisitions or proposed acquisitions:

• by a foreign person (as defined in the Foreign Takeovers Act) or associated foreign persons that would result in such persons having an interest in 20% or more of the issued shares of, or control of 20% or more of the voting power in, an Australian company; and

• by non-associated foreign persons that would result in such foreign persons having an aggregate interest in 40% or more of the issued shares of, or control of 40% or more of the voting power in, an Australian company, where the Australian company is valued above the monetary threshold prescribed by Foreign Takeovers Act.

However, in general terms, no such review or approval under the Foreign Takeovers Act is required if the foreign acquirer is a U.S. entity or an entity from certain other countries and the value of the target is less than A$1,154 million, unless the company operates in certain sensitive industries. Exemptions do not apply to investments by foreign governments and their associated entities.

The Australian Federal Treasurer may prevent a proposed acquisition in the above categories or impose conditions on such acquisition if the Treasurer is satisfied that the acquisition would be contrary to the national interest. If a foreign person acquires shares or an interest in shares in an Australian company in contravention of the Foreign Takeovers Act, the Australian Federal Treasurer may make a range of orders including an order the divestiture of such person’s shares or interest in shares in that Australian company.

Ownership Threshold

There are no specific provisions in our Constitution that require a shareholder to disclose ownership above a certain threshold. The Corporations Act, however, requires a shareholder to notify us and the ASX once it, together with its associates, acquires a 5% interest in our ordinary shares, at which point the shareholder will be considered to be a “substantial” shareholder. Further, once a shareholder owns (alone or together with associates) a 5% interest in us, such shareholder must notify us and the ASX of any increase or decrease of 1% or more in its holding of our ordinary shares, and must also notify us and the ASX on its ceasing to be a “substantial” shareholder. As we are also a U.S. public company, our shareholders are also subject to disclosure requirements under U.S. securities laws.

Issues of Shares and Change in Capital

Subject to our Constitution, the Corporations Act, the ASX Listing Rules and any other applicable law, we may at any time issue shares and give any person a call or option over any shares on any terms, with preferential, deferred or special rights, privileges or conditions or with any restrictions and for the consideration and other terms that the directors determine.

Subject to the requirements of our Constitution, the Corporations Act, the ASX Listing Rules and any other applicable law, including relevant shareholder approvals, we may consolidate or divide our share capital into a larger or smaller number by resolution, reduce our share capital in any manner (provided that the reduction is fair and reasonable to our shareholders as a whole, does not materially prejudice our ability to pay creditors and obtains the necessary shareholder approval) or buy back our ordinary shares whether under an equal access buy-back or on a selective basis.

Change of Control

Takeovers of listed Australian public companies, such as Kazia, are regulated by the Corporations Act, which prohibits the acquisition of a “relevant interest” in issued voting shares in a listed company if the acquisition will lead to that person’s or someone else’s “voting power” (being the person’s relevant interests plus those of its associates) in Kazia’s issued shares increasing from 20% or below to more than 20% or increasing from a starting point that is above 20% and below 90% (“Takeovers Prohibition”), subject to a range of exceptions.

Generally, a person will have a relevant interest in securities if the person:

• is the holder of the securities or the holder of an ADS over the shares;

• has power to exercise, or control the exercise of, a right to vote attached to the securities; or

• has the power to dispose of, or control the exercise of a power to dispose of, the securities, including any indirect or direct power or control.

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If, at a particular time:

• a person has a relevant interest in issued securities; and

• the person has:

• entered or enters into an agreement with another person with respect to the securities;

• given or gives another person an enforceable right, or has been or is given an enforceable right by another person, in relation to the securities (whether the right is enforceable presently or in the future and whether or not on the fulfillment of a condition); or

• granted or grants an option to, or has been or is granted an option by, another person with respect to the securities; and

• the other person would have a relevant interest in the securities if the agreement were performed, the right enforced or the option exercised,

Then the other person is taken to already have a relevant interest in the securities.

There are a number of exceptions to the Takeovers Prohibition on acquiring a relevant interest in issued voting shares above 20%. In general terms, some of the more significant exceptions include:

• when the acquisition results from the acceptance of an offer under a formal takeover bid;

• when the acquisition is conducted on market by or on behalf of the bidder during the bid period for a full takeover bid that is unconditional or only conditional on certain ‘prescribed’ matters set out in the Corporations Act,

• when the acquisition has been previously approved by shareholders of Kazia by resolution passed at general meeting;

• an acquisition by a person if, throughout the six months before the acquisition, that person or any other person has had voting power in Kazia of at least 19% and, as a result of the acquisition, none of the relevant persons would have voting power in Kazia more than three percentage points higher than they had six months before the acquisition;

• when the acquisition results from the issue of securities under a pro rata rights issue;

• when the acquisition results from the issue of securities under a dividend reinvestment scheme or bonus share plan;

• when the acquisition results from the issue of securities under certain underwriting arrangements;

• when the acquisition results from the issue of securities through a will or through operation of law;

• an acquisition that arises through the acquisition of a relevant interest in another listed company which is listed on a prescribed financial market or a foreign market approved by ASIC;

• an acquisition arising from an auction of forfeited shares conducted on-market; or

• an acquisition arising through a compromise, arrangement, liquidation or buy-back.

Breaches of the takeovers provisions of the Corporations Act are criminal offenses. The Australian Securities and Investments Commission, or ASIC, and the Australian Takeover Panel have a wide range of powers relating to breaches of takeover provisions or other circumstances deemed to be unacceptable (whether or not they involve a breach of the takeover provisions), including the ability to make orders canceling contracts, freezing transfers of, and rights attached to, securities, and forcing a party to dispose of securities. There are certain defenses to breaches of the takeover provisions provided in the Corporations Act.

Access to and Inspection of Documents

Inspection of our records is governed by the Corporations Act. Any member of the public has the right to inspect or obtain copies of our registers on the payment of a prescribed fee. Shareholders are not required to pay a fee for inspection of our registers or minute books of the meetings of shareholders. Other corporate records, including minutes of directors’ meetings, financial records and other documents, are not open for inspection by shareholders. Where a shareholder is acting in good faith and an inspection is deemed to be made for a proper purpose, a shareholder may apply to the court to make an order for inspection of our books.

C. Material contracts

License Agreement with Genentech Inc.

In October 2016, the Company entered into a worldwide licensing agreement with Genentech, a member of the Roche Group, to develop and commercialise GDC-0084, a small molecule inhibitor of the phosphoinositide-3-kinase (PI3K) pathway. Under the terms of the agreement, the Company paid Genentech an upfront payment of US$5 million. In addition, the terms of the agreement call for performance-related consideration linked to regulatory and commercial outcomes and royalty payments in-line with industry benchmarks.

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Acquisition of Glioblast Pty Ltd—Share Sale Agreement with Kilinwata Investments Pty. Ltd., Mi Ok Chong and Paul Hopper

In October 2016, the Company acquired 100% of the issued shares of Glioblast Pty Ltd, a privately-held, neuro-oncology-focused Australian biotechnology company. The transaction included an upfront payment of A$2.1 million, comprising A$600,000 in cash and ordinary fully-paid shares valued at A$1.5 million, with the actual number of shares determined on the basis of the volume-weighted average price of the Company’s shares on the ASX in the seven days prior to this announcement. The shareholders of Glioblast will be eligible for further payments in cash or equity on the achievement of performance related milestones. The first two of these milestones provide for the issue of ordinary fully-paid shares valued at A$1.25 million respectively on commencement and successful completion of a phase II clinical trial of GDC-0084, with the actual number of shares determined on the basis of the volume-weighted average price of the Company’s shares on the ASX in the seven days prior to satisfaction of the relevant milestone being announced. A further two milestones may trigger payments in cash or equity at the Company’s sole discretion. Any issue of equity in the Company will be subject to a minimum six-month escrow period.

At the date of this report, one milestone has lapsed and two have been settled in shares. The remaining milestone relates to the successful completion of a Phase II trial in GDC-0084.

Convertible Note Deed Poll and Amendment

On December 4, 2014, we and Triaxial signed a Convertible Note Deed Poll (‘Deed’) which superseded a Loan Agreement. The Deed extinguishes the liability created by the Loan Agreement, which previously allowed for a cash settlement and now allows Triaxial to convert their debt into ordinary shares, provided that the Company achieves defined milestones established in the schedule of the Deed. Accordingly, the convertible note has been reclassified as an equity instrument rather than debt instrument.

During the fiscal 2017, the Company reached two milestones triggering the conversion of a portion of its convertible note as follows;

• On August 11, 2016 the Company announced the submission of an IND application. On September 10, 2016, the Company received a letter from the FDA advising the study may proceed. This triggered the conversion of Convertible Notes with a face value of A$500,000 into 20,000,000 ordinary shares.

• on October 31, 2016, the Company announced it had licensed a Phase II ready molecule. This triggered the conversion of Convertible Notes with a face value of A$400,000 into 16,000,000 ordinary shares.

During fiscal 2018, A$136,000 of the Convertible Notes was extinguished. The remaining Convertible Notes with a face value of A$464,000 at year end may be converted into 1,856,000 ordinary shares of the Company (post share consolidation).

The remaining portion of the convertible note will be exercised at the holders’ discretion on completion of Phase II clinical trial or achieving “Breakthrough Designation”. Completion will be deemed to occur upon the receipt by the Company of a signed study report or notification of the designation. There is a possibility for an early conversion of the Convertible Notes if a third party acquires more than 50% of the issued capital of the Company.

Clinical Trial Collaboration and Supply Agreement with the Global Coalition for Adaptive Research

In October 2020, the Company entered into a Clinical Trial Collaboration and Supply Agreement with the Global Coalition for Adaptive Research (GCAR), a US-based 501(C)(3) non-profit organisation. The agreement relates to the inclusion of Kazia’s investigational new drug, paxalisib (GDC-0084) in a phase II/III adaptive clinical trial known as GBM AGILE (NCT03970447), which is expected to serve as the pivotal study for registration of paxalisib in glioblastoma by the US Food and Drug Administration (FDA). Under the terms of the agreement, the Company paid GCAR an upfront payment of US$5 million on execution, and will make further payments to GCAR throughout the course of the study, as defined milestones are met, with the total cost of the study capped at a pre-defined amount under the terms of the agreement. GCAR will serve as the sponsor of GBM AGILE and the company will supply investigational product for conduct of the study at its sole expense. It is expected that paxalisib’s participation in GBM AGILE will be approximately three to four years in duration.

License Agreement with Oasmia Pharmaceutical AB

In March 2021, the Company entered into an exclusive worldwide license agreement with Oasmia Pharmaceutical A, an innovation-focused specialty pharmaceutical company, for Cantrixil (TRX-E-002-1), a clinical-stage, first-in-class drug candidate under development for the treatment of ovarian cancer. Under the terms of the agreement, Oasmia assumed worldwide exclusive rights to develop and commercialise Cantrixil for all indications, with an initial focus on ovarian cancer. During fiscal 2021, Oasmia made an upfront payment of US$4 million, with contingent milestones of up to US$42 million and double-digit royalties on commercial sales.

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License Agreement with Simcere Pharmaceutical Group Ltd

In March 2021, the Company entered into a licensing agreement with Simcere Pharmaceutical Group Ltd (“Simcere”) to develop and commercialise the Company’s investigational new drug, paxalisib, in Greater China. Under the terms of the agreement, Simcere assumed responsibility for the development, registration and commercialization of paxalisib in Greater China (a territory which includes Mainland China, Hong Kong, Macau and Taiwan). The Company received an upfront payment of US$11 million comprising US$7 million in cash and a US$4 million equity investment, priced at a 20% premium to recent trading. The Company will also receive contingent milestone payments of up to US$281 million for glioblastoma, with further milestones payable for indications beyond glioblastoma. Simcere will additionally pay mid-teen percentage royalties on commercial sales.

License Agreement with Evotec SE

In April 2021, the Company entered into a worldwide exclusive licensing agreement with Evotec SE, a leading European drug discovery and development company, for EVT801, a small-molecule, first-in-class oncology drug candidate. Under the terms of the agreement, Evotec has granted Kazia an exclusive license to develop, manufacture, and commercialize EVT801 in all territories and indications. The Company paid an up-front amount of €1 million (approximately A$1.6 million). In addition, the terms of the agreement call for performance-related consideration linked to regulatory and commercial outcomes up to a maximum of €308 million (approximately A$480 million) and tiered single-digit royalty payments.

D. Exchange controls

Australia has largely abolished exchange controls on investment transactions. The Australian dollar is freely convertible into U.S. dollars. In addition, (other than as specified under “taxation” below and certain restrictions imposed under Australian law in relation to dealings with the assets of and transactions with, designated countries, entities and persons specified by the Australian Government Department of Foreign Affairs and Trade from time to time, including, persons connected with terrorism) there are currently no specific rules or limitations regarding the export from Australia of profits, dividends, capital, or similar funds belonging to foreign investors, except that certain payments to non-residents must be reported to the Australian Transaction Reports and Analysis Centre, which monitors such transactions.

Under Australian law, foreign persons require the approval from the Australian Treasurer to acquire more than a limited percentage of the interests in an Australian company. These limitations are set forth in the Australian Foreign Acquisitions and Takeovers Act 1975 (Cth) (the “Foreign Takeovers Act”).

Under the Foreign Takeovers Act, in general terms, the approval of the Australian Treasurer is required for any foreign person (either alone or together with any one or more of its associates) to acquire an interest of 20% or more of the voting power (including potential voting power) or issued shares (including rights to issued shares) (“Substantial Interest”) in an Australian entity, whose total issued securities value or total asset value (whichever is higher) exceed A$275 million. If the person is a U.S. investor, the A$275 million threshold applies only for investments in prescribed sensitive sectors, otherwise a threshold of A$1,192 million rather than A$275 million applies. All direct investment by foreign governments and their related entities regardless of the value of the investment, including proposals to establish new businesses, must be notified to the Australian Treasurer. Where an acquisition is made in breach of these requirements, the Australian Treasurer may make a range of orders including an order requiring the acquirer to dispose of its Substantial Interest within a specified period of time.

In addition, if a foreign person acquires a Substantial Interest in Kazia in circumstances where the above monetary thresholds would be exceeded and as a result the total holdings of all foreign persons and their associates exceeds 40% in aggregate without the approval of the Australian Treasurer, then the Australian Treasurer may make a range of orders including an order requiring the acquirer to dispose of its Substantial Interest within a specified period of time. The same rule applies if the total holdings of all foreign persons and their associates already exceeds 40% and a foreign person (or its associate) acquires any further interests, including in the course of trading in the secondary market of the ADSs.

Under the current Australian foreign investment policy, the Australian Treasurer has the power to make such an order in relation to an acquisition that contravenes the Foreign Takeovers Act where the level of foreign ownership exceeds 40% in the ordinary course of trading, if the Australian Treasurer is satisfied that the acquisition is contrary to the national interest. The Foreign Takeovers Act allows foreign persons to seek prior approval of acquisitions of Kazia interests which could otherwise result in the Australian Treasurer making an order requiring the foreign person to dispose of any Substantial Interest.

If a foreign person holds more than 20% of the interests of Kazia or if the level of aggregate foreign ownership of Kazia exceeds 40% at any time, Kazia would be considered a foreign person under the Foreign Takeovers Act. In such event, Kazia would be required to obtain the approval of the Australian Treasurer for Kazia, together with its associates, to acquire: (i) more than 20% of an Australian company or business with a total issued securities value or total asset value (whichever is higher) totaling over A$275 million; or (ii) any direct or indirect ownership interest in Australian land. However, as mentioned above, in general terms, proposals by U.S. investors for investment in non-sensitive sectors do not require notification to the Australian Treasurer or the Australian Treasurer’s approval unless the value of the target Australian company or business exceeds A$1,192 million.

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The percentage of foreign ownership of Kazia would also be included in determining the foreign ownership of any Australian company or business in which it may choose to invest. Kazia has no current plans for any such acquisitions. The Company’s Constitution does not impose specific limitations on a non-resident’s right to hold or vote the Company’s securities.

E. Taxation

U.S. Taxation

This section describes the material U.S. federal income tax consequences to a U.S. holder (as defined below) of owning ordinary shares or ADSs. It applies only to ordinary shares or ADSs that are held as capital assets for tax purposes. This section does not apply to a holder of ordinary shares or ADSs that is a member of a class of holders subject to special rules, including a financial institution, a dealer or trader in securities, a regulated investment company, a real estate investment trust, a grantor trust, a U.S. expatriate, a tax-exempt organization, an insurance company, a person liable for alternative minimum tax, a person who actually or constructively owns 10% or more of the stock of the Company, a person that holds ordinary shares or ADSs as part of a straddle or a hedging or conversion transaction, a person that purchases or sells ordinary shares or ADSs as part of a wash sale for tax purposes, or a person whose functional currency is not the U.S. dollar. Further, this description does not address state, local, non-U.S, or other tax laws, nor does it address the 3.8% U.S. federal Medicare tax on net investment income, the alternative minimum tax or the U.S. federal gift and estate tax consequences of owning and disposing of ordinary shares or ADSs.

For purposes of this description, a “U.S. holder” is a beneficial owner of ordinary shares or ADSs who holds such ordinary shares or ADSs as capital assets within the meaning of the Code and is, for U.S. federal income tax purposes: (i) an individual citizen or resident of the United States; (ii) a corporation created or organized in or under the laws of the United States or any state thereof, including the District of Columbia; (iii) an estate the income of which is subject to U.S. federal income taxation regardless of its source; or (iv) a trust that either (a) is subject to the supervision of a court within the United States and has one or more U.S. persons with authority to control all substantial decisions or (b) has a valid election in effect under applicable Treasury Regulations to be treated as a U.S. person.

If a partnership holds the ordinary shares or ADSs, the U.S. federal income tax treatment of a partner generally will depend on the status of the partner and the tax treatment of the partnership. A partner in a partnership holding the ordinary shares or ADSs should consult its tax advisor with regard to the U.S. federal income tax treatment of an investment in the ordinary shares or ADSs.

This section is in part based on the representations of the Depositary and the assumption that each obligation in the deposit agreement and any related agreement will be performed in accordance with its terms. In general, for U.S. federal income tax purposes, a holder of ADSs will be treated as the owner of the ordinary shares represented by those ADSs. Exchanges of ordinary shares for ADSs, and ADSs for ordinary shares generally will not be subject to U.S. federal income tax.

Distributions

Subject to the Passive Foreign Investment Company (“PFIC”) rules discussed below, U.S. holders generally will include as dividend income the U.S. dollar value of the gross amount of any distributions of cash or property (without deduction for any withholding tax), other than certain pro rata distributions of ordinary shares, with respect to ordinary shares or ADSs to the extent the distributions are made from our current or accumulated earnings and profits, as determined for U.S. federal income tax purposes. A U.S. holder will include the dividend income on the day actually or constructively received (i) by the holder, in the case of ordinary shares, or (ii) by the depositary, in the case of ADSs. We do not intend to maintain calculations of earnings and profits, as determined for U.S. federal income tax purposes. Consequently, any distributions generally will be treated as dividend income.

Dividends paid to a non-corporate U.S. holder on shares or ADSs will generally be taxable at the preferential rates applicable to long-term capital gains provided (a) that certain holding period requirements are satisfied, (b) (i) the U.S.-Australia income tax treaty (“the Treaty”) is a qualified treaty and we are eligible for benefits under the Treaty or (ii) our ordinary shares or ADSs are readily tradable on a U.S. securities market, and (c) provided that we were not, in the taxable year prior to the year in which the dividend was paid, and are not, in the taxable year in which the dividend is paid, a PFIC. The Treaty has been approved for the purposes of the qualified dividend rules and the ADSs are listed on NASDAQ. If the Company is a PFIC, any dividends paid to a noncorporate U.S. holder will not qualify for the preferential tax rates ordinarily applicable to “qualified dividends.” In the case of a corporate U.S. holder, dividends on shares and ADSs are taxed as ordinary income and will not be eligible for the dividends received deduction generally allowed to U.S. corporations in respect of dividends received from other U.S. corporations.

The amount of any cash distribution paid in any foreign currency will be equal to the U.S. dollar value of such currency, calculated by reference to the spot rate in effect on the date such distribution is received by the U.S. holder or, in the case of ADSs, by the Depositary, regardless of whether and when the foreign currency is in fact converted into U.S. dollars. If the foreign currency is converted into U.S. dollars on the date received, the U.S. holder generally should not recognize foreign currency gain or loss on such conversion. If the foreign currency is not converted into U.S. dollars on the date received, the U.S. holder will have a basis in the foreign currency equal to its U.S. dollar value on the date received, and generally will recognize foreign currency gain or loss on a subsequent conversion or other disposal of such currency. Such foreign currency gain or loss generally will be treated as U.S. source ordinary income or loss for foreign tax credit limitation purposes.

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Dividends will be income from sources outside the United States, and generally will be “passive category” income or, for certain taxpayers, “general category” income, which are treated separately from each other for the purpose of computing the foreign tax credit allowable to a U.S. holder. The availability of the foreign tax credit and the application of the limitations on its availability are fact specific and are subject to complex rules. In general, a taxpayer’s ability to use foreign tax credits may be limited and is dependent on the particular circumstances. U.S. holders should consult their own tax advisors with respect to these matters.

Sale, Exchange or other Disposition of Ordinary Shares or ADSs

Subject to the PFIC rules discussed below, a U.S. holder who sells or otherwise disposes of ordinary shares or ADSs will recognize a capital gain or loss for U.S. federal income tax purposes equal to the difference between the U.S. dollar value of the amount realized and the holder’s tax basis, determined in U.S. dollars, in those ordinary shares or ADSs. The gain or loss will generally be income or loss from sources within the United States for foreign tax credit limitation purposes. The capital gain of a non-corporate U.S. holder is generally taxed at preferential rates where the holder has a holding period greater than 12 months in the shares or ADSs sold. There are limitations on the deductibility of capital losses.

The U.S. dollar value of any foreign currency received upon a sale or other disposition of ordinary shares or ADSs will be calculated by reference to the spot rate in effect on the date of sale or other disposal (or, in the case of a cash basis or electing accrual basis taxpayer, at the spot rate of exchange on the settlement date). A U.S. holder will have a tax basis in the foreign currency received equal to that U.S. dollar amount, and generally will recognize foreign currency gain or loss on a subsequent conversion or other disposal of the foreign currency. This foreign currency gain or loss generally will be treated as U.S. source ordinary income or loss for foreign tax credit limitation purposes. If such foreign currency is converted into U.S. dollars on the date received by the U.S. holder, a cash basis or electing accrual basis U.S. holder should not recognize any gain or loss on such conversion.

Passive Foreign Investment Company

A non-U.S. corporation will be a PFIC for U.S. federal income tax purposes for any taxable year if either:

• 75% or more of its gross income for such year is “passive income” which for this purpose generally includes dividends, interest, royalties, rents and gains from commodities and securities transactions and gains from assets that produce passive income; or

• 50% or more of the value of its gross assets (based on an average of the quarterly values of the gross assets) during such year is attributable to assets that produce passive income or are held for the production of passive income.

Passive income does not include rents and royalties derived from the active conduct of a trade or business. If the stock of a non-U.S. corporation is publicly traded for the taxable year, the asset test is applied using the fair market value of the assets for purposes of measuring such corporation’s assets. If we own at least 25% (by value) of the stock of another corporation, we will be treated, for purposes of the PFIC tests, as owning our proportionate share of the other corporation’s assets and receiving our proportionate share of the other corporation’s income for purposes of the PFIC income and asset tests. If the stock of a non-U.S. corporation is publicly-traded for the taxable year, the asset test is applied using the fair market value of the assets for purposes of measuring such corporation’s assets. If we were a PFIC in any year during a U.S. holder’s holding period for our ordinary shares or ADSs, we would ordinarily continue to be treated as a PFIC for each subsequent year during which the U.S. holder owned the ordinary shares or ADSs. Based on the composition of our assets and income, we believe that we may be treated as a PFIC for U.S. federal income tax purposes with respect to our 2021 taxable year. However, the determination of PFIC status is a factual determination that must be made annually at the close of each taxable year and therefore, there can be no certainty as to our status in this regard until the close of the current or any future taxable year. Changes in the nature of our income or assets or a decrease in the trading price of our ordinary shares or ADSs may cause us to be considered a PFIC in the current or any subsequent year.

U.S. Information Reporting and Back-up Withholding

Dividend payments with respect to our ordinary shares or ADSs and proceeds from the sale or other disposition of our ordinary shares or ADSs may be subject to information reporting to the IRS and possible U.S. backup withholding. Back-up withholding will not apply, however, to a U.S. holder who furnishes a correct taxpayer identification number and makes any other required certification or who is otherwise exempt from back-up withholding. U.S. holders who are required to establish their exempt status may be required to provide such certification on Internal Revenue Service (“IRS”) Form W-9. U.S. holders should consult their tax advisors regarding the application of the U.S. information reporting and back-up withholding rules.

Back-up withholding is not an additional tax. Amounts withheld as back-up withholding may be credited against a U.S. holder’s U.S. federal income tax liability, and such holder may obtain a refund of any excess amounts withheld under the back-up withholding rules by timely filing the appropriate claim for refund with the IRS and furnishing any required information.

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Information With Respect to Foreign Financial Assets

Certain U.S. holders that own “specified foreign financial assets” with an aggregate value in excess of $50,000 are generally required to file an information statement along with their U.S. federal tax returns, currently on IRS Form 8938, with respect to such assets. “Specified foreign financial assets” include any financial accounts held at a non-U.S. financial institution, as well as securities issued by a non-U.S. issuer that are not held in accounts maintained by financial institutions. If a U.S. holder does not include in such holder’s gross income an amount relating to one or more specified foreign financial assets, and the amount such U.S. holder omits is more than $5,000, any tax such U.S. holder owes for the tax year can be assessed at any time within 6 years after the filing of such U.S. holder’s federal tax return. U.S. holders who fail to report the required information could be subject to substantial penalties. U.S. holders are encouraged to consult with their own tax advisors regarding the possible application of the foregoing to our ordinary shares or ADSs in light of their particular circumstances.

Australian Tax Considerations

In this section, we discuss the material Australian income tax, stamp duty and goods and services tax considerations related to the acquisition, ownership and disposal by the absolute beneficial owners of the ordinary shares or ADSs.

It is based upon existing Australian tax law as of the date of this registration statement, which is subject to change, possibly retrospectively. This discussion does not address all aspects of Australian tax law which may be important to particular investors in light of their individual investment circumstances, such as shares held by investors subject to special tax rules (for example, financial institutions, insurance companies or tax-exempt organizations). In addition, this summary does not discuss any foreign or state tax considerations, other than stamp duty.

Prospective investors are urged to consult their tax advisors regarding the Australian and foreign income and other tax considerations of the acquisition, ownership and disposition of the shares. This summary is based upon the premise that the holder is not an Australian tax resident and is not carrying on business in Australia through a permanent establishment (referred to as a “Non-Australian Shareholder” in this summary).

Australian Income Tax

Nature of ADSs for Australian Taxation Purposes

Ordinary shares represented by ADSs held by a U.S. holder will be treated for Australian taxation purposes as held under a “bare trust” for such holder. Consequently, the underlying ordinary shares will be regarded as owned by the ADS holder for Australian income tax and capital gains tax purposes. Dividends paid on the underlying ordinary shares will also be treated as dividends paid to the ADS holder, as the person beneficially entitled to those dividends. Therefore, in the following analysis we discuss the tax consequences to Non-Australian Shareholders which, for Australian taxation purposes, will be the same as to U.S. holders of ADSs.

Taxation of Dividends

Australia operates a dividend imputation system under which dividends may be declared to be “franked” to the extent of tax paid on company profits. Fully franked dividends are not subject to dividend withholding tax. Dividends payable to Non-Australian Shareholders will be subject to dividend withholding tax, to the extent the dividends are not declared to be conduit foreign income, or CFI, and are unfranked. Dividend withholding tax will be imposed at 30%, unless a shareholder is a resident of a country with which Australia has a double taxation agreement and qualifies for the benefits of the treaty. In accordance with the provisions of the Double Taxation Convention between Australia and the United States, the maximum rate of Australian withholding tax on any unfranked portion of a dividend to which a resident of the United States is beneficially entitled is 15%, where the U.S. resident holds less than 10% of the voting rights in our company, or 5% where the U.S. resident holds 10% or more of the voting rights in our company. The Double Taxation Convention does not apply to impose withholding tax on dividends where the ADSs are effectively connected to a permanent establishment or a fixed base carried on by the owner of the ADSs in Australia through which the Non-Australian Shareholders carry on business or provide independent personal services, respectively. In such a case, the provisions of Article 7 (Business profits) or Article 14 (Independent personal services) of the Double Taxation Conventions, as the case may be, shall apply.

Tax on Sales or other Dispositions of Shares—Capital Gains Tax

Non-Australian Shareholders will not be subject to Australian capital gains tax on the gain made on a sale or other disposal of ordinary shares, unless they, together with associates, hold 10% or more of our issued capital, at the time of disposal or for 12 months of the last two years prior to disposal.

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Non-Australian Shareholders who own a 10% or more interest would be subject to Australian capital gains tax if more than 50% of our assets held directly or indirectly, determined by reference to market value, consists of Australian real property (which includes land and leasehold interests) or Australian mining, quarrying or prospecting rights. The Double Taxation Convention between the United States and Australia is unlikely to limit the amount of this taxable gain. Australian capital gains tax applies to net capital gains of foreign shareholders at the Australian tax rates for non-Australian residents, which start at a marginal rate of 32.5% for individuals (or a flat rate of 26%-30% (2021) & 25%-30% (2022) for companies, depending on the size of the company). Net capital gains are calculated after reduction for capital losses, which may only be offset against capital gains.

The 50% capital gains tax discount is not available to Non-Australian Shareholders. Companies are not entitled to a capital gains tax discount.

Broadly, where there is a disposal of certain taxable Australian property, the purchaser will be required to withhold and remit to the Australian Taxation Office (“ATO”) 12.5% of the proceeds from the sale. A transaction is excluded from the withholding requirements in certain circumstances, including where the value of the taxable Australian property is less than A$750,000, the transaction is an on-market transaction conducted on an approved stock exchange, a securities lending, or the transaction is conducted using a broker operated crossing system. There is also an exception to the requirement to withhold where the entity selling the shares provides the purchaser a declaration specifying either that they are an Australian resident or that the shares are not taxable Australian property (specifically, not ‘indirect Australian real property interests’). The Non-Australian Shareholder may be entitled to receive a tax credit for the tax withheld by the purchaser which they may claim in their Australian income tax return.

Tax on Sales or other Dispositions of Shares—Shareholders Holding Shares on Revenue Account

Some Non-Australian Shareholders may hold ordinary shares on revenue rather than on capital account for example, share traders. These shareholders may have the gains made on the sale or other disposal of the ordinary shares and/or warrants included in their assessable income under the ordinary income provisions of the income tax law, if the gains are sourced in Australia.

Non-Australian Shareholders assessable under these ordinary income provisions in respect of gains made on ordinary shares held on revenue account would be assessed for such gains at the Australian tax rates for non-Australian residents, which start at a marginal rate of 32.5% for individuals (or a flat rate of 26%-30% (2021) & 25%-30% (2022) for companies, depending on the size of the company). Some relief from Australian income tax may be available to Non-Australian Shareholders under the Double Taxation Convention between the United States and Australia.

To the extent an amount would be included in a Non-Australian Shareholder’s assessable income under both the capital gains tax provisions and the ordinary income provisions, the capital gain amount would generally be reduced, so that the shareholder would not be subject to double tax on any part of the income gain or capital gain.

The comments above in “Tax on Sales or Other Dispositions of Shares—Capital Gains Tax” regarding a purchaser being required to withhold 12.5% tax on the acquisition of certain taxable Australian property equally applies where the disposal of the Australian real property asset by a foreign resident is likely to generate gains on revenue account, rather than a capital gain.

Dual Residency

If a shareholder is a resident of both Australia and the United States under those countries’ domestic taxation laws, that shareholder may be subject to tax as an Australian resident. If, however, the shareholder is determined to be a U.S. resident for the purposes of the Double Taxation Convention between the United States and Australia, the Australian tax would be subject to limitation by the Double Taxation Convention (albeit the tie-breaker rules only apply for individuals). Shareholders should obtain specialist taxation advice in these circumstances.

Stamp Duty

No Australian stamp duty is payable by Australian residents or non-Australian residents on the issue, transfer and/or surrender of the ADSs or the ordinary shares in Kazia, provided that the shares issued, transferred and/or surrendered do not represent 90% or more of the issued shares in Kazia.

Australian Death Duty

Australia does not have estate or death duties. As a general rule, no capital gains tax liability is realized upon the inheritance of a deceased person’s shares. The disposal of inherited shares by beneficiaries may, however, give rise to a capital gains tax liability if the gain falls within the scope of Australia’s jurisdiction to tax.

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Goods and Services Tax

The supply of ADSs or ordinary shares in Kazia will not be subject to Australian goods and services tax.

F. Dividends and paying agents

Not applicable

G. Statement by experts

Not applicable

H. Documents on Display

The Company is subject to the reporting requirements of the Exchange Act that are applicable to a foreign private issuer. Under the Exchange Act, the Company is required to file periodic reports and other information with the SEC. These materials, including this Annual Report and the exhibits hereto, may be inspected without charge and copied at established rates at the public reference facilities maintained by the SEC at 100 F Street, N.E., Washington, D.C., 20549. Please call the SEC at 1-800-SEC-0330 to obtain information on the operation of the public reference room. Such materials can also be obtained at the SEC’s website at www.sec.gov.

I. Subsidiary Information

Not applicable

Item 11. Quantitative and Qualitative Disclosures about Market Risk

Interest rate risk

The Company’s exposure to market interest rates relate primarily to the investments of cash balances. The Company has cash reserves held primarily in Australian dollars and places funds on deposit with financial institutions for periods generally not exceeding three months.

Credit risk

The Company places its deposits with high credit quality financial institutions, and, by policy, limits the amount of credit exposure to any single counter-party. The Company is averse to principal loss and ensures the safety and preservation of its invested funds by limiting default risk, market risk and reinvestment risk. The Company mitigates default risk by depositing funds with only the safest and highest credit quality financial institutions and by constantly positioning its portfolio to respond appropriately to a significant reduction in a credit rating of any financial institution.

The Company has no interest rate exposure due to rate changes for long-term debt obligations. The Company primarily enters into debt obligations to support general corporate purposes, including capital expenditures and working capital needs. The Company does not consider the effects of interest rate movements to be a material risk to its financial condition.

For additional disclosure regarding interest rate risk see Item 18. “Financial Statements – Note 21 – Financial Instruments”.

Foreign currency risk

The Company operates internationally and is exposed to foreign exchange risk arising from various currency exposures, primarily with respect to the U.S. dollar. Foreign exchange risk arises from future transactions and recognised assets and liabilities denominated in a currency that is not the entity’s functional currency and net investments in foreign operations.

As of June 30, 2021, the Company did not hold derivative financial instruments in managing its foreign currency, however, the Company may from time to time enter into hedging arrangements where circumstances are deemed appropriate. The Company used natural hedging to reduce the foreign currency risk, which involved processing USD payments from cash held in USD. Foreign subsidiaries with a functional currency of Australian Dollar (“AUD”) have exposure to the local currency of these subsidiaries and any other currency these subsidiaries trade in.

For additional disclosure regarding market risk see Item 18. “Financial Statements – Note 21 – Financial Instruments”.

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Item 12. Description of Securities Other than Equity Securities

A. Debt Securities

Not applicable

B. Warrants and Rights

Not applicable.

C. Other Securities

Not applicable

D. American Depositary Shares

The depositary collects its fees for delivery and surrender of American Depositary Shares (“ADSs”) directly from investors depositing shares or surrendering ADSs for the purpose of withdrawal or from intermediaries acting for them. The depositary collects fees for making distributions to investors by deducting those fees from the amounts distributed or by selling a portion of distributable property to pay the fees. The depositary may collect its annual fee for depositary services by deductions from cash distributions or by directly billing investors or by charging the book-entry system accounts of participants acting for them. The depositary may generally refuse to provide fee-attracting services until its fees for those services are paid. The depositary may collect any of its fees by deduction from any cash distribution payable to you that are obligated to pay those fees.

From time to time, the depositary may make payments to us to reimburse or share revenue from the fees collected from you, or waive fees and expenses for services provided, generally relating to costs and expenses arising out of establishment and maintenance of the ADS program. In performing its duties under the deposit agreement, the depositary may use brokers, dealers or other service providers that are affiliates of the depositary and that may earn or share fees or commissions.

Persons depositing or withdrawing shares must pay:		For:
US$5.00 (or less) per 100 ADSs (or portion of 100 ADSs)	•	Issuance of ADSs, including issuances resulting from a distribution of shares or rights or other property
	•	Cancellation of ADSs for the purpose of withdrawal, including if the deposit agreement terminates
US$.05 (or less) per ADS	•	Any cash distribution to ADS registered holders
A fee equivalent to the fee that would be payable if securities distributed to you had been shares and the shares had been deposited for issuance of ADSs	•	Distribution of securities distributed to holders of deposited securities which are distributed by the depositary to ADS registered holders
US$.05 (or less) per ADSs per calendar year	•	Depositary services
Registration or transfer fees	•	Transfer and registration of shares on the Company’s share register to or from the name of the depositary or its agent when you deposit or withdraw shares
Expenses of the depositary	•	Cable, telex and facsimile transmissions (when expressly provided in the deposit agreement)
	•	Converting foreign currency to U.S. dollars
Taxes and other governmental charges the depositary or the custodian have to pay on any ADS or share underlying an ADS, for example, stock transfer taxes, stamp duty or withholding taxes	•	As necessary
Any charges incurred by the depositary or its agents for servicing the deposited securities	•	As necessary

The Depositary may collect any of the fees by deduction from any cash distribution payable, or by selling a portion of any securities to be distributed, to holders that are obligated to pay those fees.

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PART II

Item 13. Defaults, Dividend Arrearages and Delinquencies

This item is not applicable.

Item 14. Material Modifications to the Rights of Security Holders and the Use of Proceeds

This item is not applicable.

Item 15. Controls and Procedures

(a) Disclosure controls and procedures

At the end of the period covered by this Annual Report, the Company’s management, with the participation of the Chief Executive Officer and the Director of Finance and Administration, evaluated the effectiveness of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Based on that evaluation, the Company’s Chief Executive Officer and the Director of Finance and Administration have concluded that the Company’s disclosure controls and procedures are effective as of June 30, 2021.

(b) Management’s annual report on internal controls over financial reporting

The management of Kazia Therapeutics Limited is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) under the Exchange Act. Under the supervision and with the participation of our management, including our Chief Executive Officer and Director of Finance and Administration, we conducted an evaluation of the effectiveness of our internal control over financial reporting as of June 30, 2021 based on the criteria set forth in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO 2013). Based on our evaluation under the criteria set forth in Internal Control — Integrated Framework, our management concluded that our internal control over financial reporting was effective as of June 30, 2021.

Kazia Therapeutics Limited’s internal control was designed to provide reasonable assurance to the Company’s management and Board of Directors regarding the preparation and fair presentation of published financial statements. All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation.

Management maintains a comprehensive system of controls intended to ensure that transactions are executed in accordance with management’s authorization, assets are safeguarded, and financial records are reliable. Management also takes steps to ensure that information and communication flows are effective and monitor performance, including performance of internal control procedures.

Management assessed the effectiveness of the Company’s internal control over financial reporting as of June 30, 2021. Based on this assessment, management concluded that the Company’s internal control over financial reporting is effective as of June 30, 2021.

(c) Attestation Report of the Registered Public Accounting Firm

Not applicable.

(d) Changes in Internal Control over Financial Reporting

There was no change in our internal control over financial reporting that occurred during the period covered by this annual report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Item 16. [Reserved]

Item 16A. Audit Committee Financial Expert

The Board of Directors has determined that Steven Coffey, qualifies as an “audit committee financial expert” as that term is defined in Item 16A of Form 20-F. Steven Coffey meets the independence requirements of the NASDAQ Capital Market and SEC’s rules and regulations as he is a qualified Chartered Accountant and has spent over 30 years in public practice. He is also a registered company auditor.

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Item 16B. Code of Ethics

The Company has adopted a Code of Ethics and Business Conduct (the “Code”). The Code establishes a clear set of values that emphasise a culture encompassing strong corporate governance, sound business practices and good ethical conduct. The Code confirms the Company’s belief in treating all individuals with respect and recognises that different skills and diversity are essential to enrich the Company’s perspective, improve corporate performance, increase shareholder value and maximise the achievement and goals of the Company. The Code applies to all Company employees, including management and Directors. The Code is available on the Company’s website www.kaziatherapeutics.com.

Item 16C. Principal Accounting Fees and Services

Grant Thornton Audit Pty Ltd (“GT”) has audited the Company’s annual financial statements acting as the independent registered public accounting firm for the fiscal years ended June 30, 2021 and 2020.

The table below set forth the total fees for services performed by GT in fiscal years 2021 and 2020, and summarizes these amounts by the category of service.

	2021 A$’000		2020 A$’000
Audit fees - Grant Thornton Audit Pty Ltd		151		124
Total fees		151		124

Audit fees

The audit fees include the aggregate fees incurred in fiscal years 2021 and 2020 for professional services rendered in connection with the audit of the Company’s annual financial statements and for related services that are reasonably related to the performance of the audit or services that are normally provided by the auditor in connection with regulatory filings of engagements for those financial years (including review of the Company’s Annual Report on Form 20-F, consents and other services related to SEC matters).

Pre-approval policies and procedures

The Audit Committee Charter sets forth the Company’s policy regarding the appointment of independent auditors. The Audit Committee Charter also requires the Audit Committee to review and approve in advance the appointment of the independent auditors for the performance of 100% of all audit services and, after taking into account the opinion of management, 100% of lawfully permitted non-audit services. The Audit Committee may delegate authority to one or more members of the Audit Committee where appropriate, but no such delegation is permitted if the authority is required by law, regulation or listing standard to be exercised by the Audit Committee as a whole.

In fiscal year 2021, the amount paid to Grant Thornton for services other than Audit fees amounted to nil.

Item 16D. Exemptions from the Listing Standards for Audit Committees

This item is not applicable.

Item 16E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers

This item is not applicable.

Item 16F. Changes in registrant’s Certifying Accountant

This item is not applicable.

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Item 16G. Corporate Governance

Implications of Being a Foreign Private Issuer

We are also considered a “foreign private issuer.” In our capacity as a foreign private issuer, we are exempt from certain rules under the U.S. Securities Exchange Act of 1934, as amended (the “Exchange Act”), that impose certain disclosure obligations and procedural requirements for proxy solicitations under Section 14 of the Exchange Act. In addition, our officers, directors and principal shareholders are exempt from the reporting and “short-swing” profit recovery provisions of Section 16 of the Exchange Act and the rules under the Exchange Act with respect to their purchases and sales of our ordinary shares. Moreover, we are not required to file periodic reports and financial statements with the SEC as frequently or as promptly as U.S. companies whose securities are registered under the Exchange Act. In addition, we are not required to comply with Regulation FD, which restricts the selective disclosure of material information.

Exemptions from Certain Corporate Governance Rules of the NASDAQ Stock Market, LLC

Exemptions from the corporate governance standards of the NASDAQ Stock Market, LLC (“NASDAQ”) are available to foreign private issuers such as Kazia when those standards are contrary to a law, rule or regulation of any public authority exercising jurisdiction over such issuer or contrary to generally accepted business practices in the issuer’s country of domicile. In connection with Kazia’s National Market Listing Application, NASDAQ granted Kazia exemptions from certain corporate governance standards that were contrary to the laws, rules, regulations or generally accepted business practices of Australia. These exemptions and the practices followed by Kazia are described below:

• Kazia is exempt from NASDAQ’s requirement that each NASDAQ issuer shall require shareholder approval of a plan or arrangement in connection with the acquisition of the stock or assets of another company if “any director, officer or substantial shareholder of the issuer has a 5 percent or greater interest (or such persons collectively have a 10 percent or greater interest), directly or indirectly, in the company or assets to be acquired or in the consideration to be paid in the transaction or series of related transactions and the present or potential issuance of common stock, or securities convertible into or exercisable for common stock, could result in an increase in outstanding common shares or voting power of 5 percent or more”. Kazia is subject to Chapter 10 of the ASX listing rules, which requires shareholder approval for an acquisition from or disposal to a “related party” (including a director) or “substantial shareholder” (who is entitled to at least 10% of the voting securities) of “substantial assets”. The Australian Corporations Act to which Kazia is also subject generally requires shareholder approval for a transaction with a director or director-controlled entity unless on arm’s length terms.

• Nasdaq requirement under Rule 5620(c) that a quorum consist of holders of 33 1/3% of the outstanding ordinary shares — The ASX Listing Rules do not have an express requirement that each issuer listed on ASX have a quorum of any particular number of the outstanding ordinary shares, but instead allow a listed issuer to establish its own quorum requirements. Our quorum is currently three shareholders. We believe this quorum requirement is consistent with the requirements of the ASX and is appropriate and typical of generally accepted business practices in Australia.

• Nasdaq requirements under Rules 5605(b)(1) and (2) relating to director independence, including the requirements that a majority of the board of directors must be comprised of independent directors and that independent directors must have regularly scheduled meetings at which only independent directors are present — The Nasdaq and ASX definitions of what constitute an independent director are not identical and the requirements relating to the roles and obligations of independent directors are not identical. The ASX, unlike Nasdaq, permits an issuer to establish its own materiality threshold for determining whether a transaction between a director and an issuer affects the director’s status as independent and it does not require that a majority of the issuer’s board of directors be independent, as long as the issuer publicly discloses this fact. In addition, the ASX does not require that the independent directors have regularly scheduled meeting at which only independent directors are present. We believe that our Board composition is consistent with the requirements of the ASX and that it is appropriate and typical of generally accepted business practices in Australia.

• The requirement that our independent directors meet regularly in executive sessions under Nasdaq Listing Rules. The ASX Listing Rules and the Corporations Act do not require the independent directors of an Australian company to have such executive sessions.

• The Nasdaq requirements under Rules 5605(d) and 5605(e) that compensation of an issuer’s officers must be determined, or recommended to the Board for determination, either by a majority of the independent directors, or a compensation committee comprised solely of independent directors, and that director nominees must either be selected, or recommended for the Board’s selection, either by a majority of the independent directors, or a nominations committee comprised solely of independent directors. The Nasdaq compensation committee requirements are not identical to the ASX remuneration and nomination committee requirements. Issuers listed on the ASX are recommended under applicable listing standards to establish a remuneration committee consisting of a majority of independent directors and an independent chairperson, or publicly disclose that it has not done so. Kazia has, and expects to continue to have, a Remuneration and Nomination Committee consisting of three non-executive directors.

50

• The requirement prescribed by Nasdaq Listing Rules that issuers obtain shareholder approval prior to the issuance of securities in connection with certain acquisitions, private placements of securities, or the establishment or amendment of certain share option, purchase or other compensation plans. Applicable Australian law and the ASX Listing Rules differ from Nasdaq requirements, with the ASX Listing Rules providing generally for prior shareholder approval in numerous circumstances, including (i) issuance of equity securities exceeding 15% (or 25% under certain circumstances) of our issued share capital in any 12-month period (but, in determining the 15% limit, securities issued under an exception to the rule or with shareholder approval are not counted), (ii) issuance of equity securities to related parties (as defined in the ASX Listing Rules) and (iii) issuances of securities to directors or their associates under an employee incentive plan.

Item 16H. Mine Safety Disclosure

This item is not applicable.

PART III

Item 17. Financial Statements

Refer to “Item 18 – Financial Statements” below

Item 18. Financial Statements

The financial statements filed as part of this Annual Report commencing on page F-1.

Item 19. Exhibits

(a) Exhibits

1.1	Constitution of Kazia Therapeutics Limited, as amended and restated on November 16, 2016 (incorporated by reference to Exhibit 1.1 to the Company’s Annual Report on Form 20-F filed with the SEC on October 25, 2017 (File No. 0-29962)).
2.1	Deposit Agreement, dated as of June 6, 2016 among Novogen Limited, The Bank of New York, as Depositary, and owners and holders from time to time of ADSs issued thereunder (incorporated by reference to Exhibit 2.1 to the Company’s Annual Report on Form 20-F filed with the SEC on October 27, 2016 (File No. 0-29962)).
4.1	Lease Agreement, dated November 1, 2015 between Coal Services Pty Limited and Novogen (incorporated by reference to Exhibit 4.1 to the Company’s Annual Report on Form 20-F filed with the SEC on October 27, 2016 (File No. 0-29962)).
4.2	Employment Agreement for Chief Executive Officer of Novogen Limited, dated December 10, 2015 (incorporated by reference to Exhibit 4.2 to the Company’s Annual Report on Form 20-F filed with the SEC on October 27, 2016 (File No. 0-29962)).
4.3	Employment Agreement for Director of Finance and Administration of Novogen Limited, dated as of July 3, 2017 (incorporated by reference to Exhibit 4.20 to the Company’s Annual Report on Form 20-F filed with the SEC on October 25, 2017 (File No. 0-29962)).
4.4	Convertible Note Deed Poll with Triaxial Pty Ltd Noteholders dated December 6, 2012 (incorporated by reference to Exhibit 4.6 to the Company’s Annual Report on Form 20-F filed with the SEC on October 27, 2016 (File No. 0-29962)).
4.5	Amendment to Convertible Note Deed Poll with Triaxial Pty Ltd Noteholders dated December 4, 2014 (incorporated by reference to Exhibit 4.7 to the Company’s Annual Report on Form 20-F filed with the SEC on October 27, 2016 (File No. 0-29962)).
4.6	Kazia Therapeutics Officers’ and Employees’ Share Option Plan (incorporated by reference to Exhibit 4.10 to the Company’s Annual Report on Form 20-F filed with the SEC on October 27, 2016 (File No.0-29962)).
4.7	Share Sale Agreement dated October 31, 2016 between Kilinwata Investments Pty. Ltd., Mi Ok Chong, Paul Hopper and Novogen Limited (Incorporated by reference to Exhibit 4.11 to the Company’s Annual Report on Form 20-F filed with the SEC on October 25, 2017 (File No. 0-29962)).
4.8	Exclusive License Agreement dated October 25, 2016 between Genentech, Inc. and Novogen Limited (incorporated by reference to Exhibit 4.12 to the Company’s Annual Report on Form 20-F filed with the SEC on October 25, 2017 (File No. 0-29962)).

51

4.9	Sabio Solutions Pty Limited Letter of Appointment – Company Secretary, dated as of September 1, 2016 (incorporated by reference to Exhibit 4.17 to the Company’s Annual Report on Form 20-F filed with the SEC on October 25, 2017 (File No. 0-29962)).
4.10	Sabio Solutions Pty Limited Contract Extension Letter, dated as of March 1, 2017 (incorporated by reference to Exhibit 4.18 to the Company’s Annual Report on Form 20-F filed with the SEC on October 25, 2017 (File No. 0-29962)).
4.11	Sabio Solutions Pty Limited Contract Extension Letter, dated as of August 23, 2017 (incorporated by reference to Exhibit 4.19 to the Company’s Annual Report on Form 20-F filed with the SEC on October 25, 2017 (File No. 0-29962)).
4.12	Investigator Initiated Clinical Trial Agreement between Kazia Therapeutics Limited and Dana-Farber/Partners Cancer Care Inc dated 17 October 2018 (incorporated by reference to Exhibit 4.12 to the Company’s Annual Report on Form 20-F filed with the SEC on October 21, 2019)
4.13	Research Funding and Supply Agreement between Alliance for Clinical Trials in Oncology Foundation and Kazia Therapeutics Limited, dated 11 June 2019 (incorporated by reference to Exhibit 4.13 to the Company’s Annual Report on Form 20-F filed with the SEC on October 21, 2019)
4.14	Master Clinical Trial Agreement between St Jude Children’s Hospital Inc. and Kazia Laboratories Pty Limited dated 17 November 2017 and associated work order date 7 June 2019 (incorporated by reference to Exhibit 4.14 to the Company’s Annual Report on Form 20-F filed with the SEC on October 21, 2019)
4.15	Memorial Sloan Kettering Cancer Center Investigator-Initiated Clinical Trial Agreement with Kazia Therapeutics Limited dated as 22 July 2019 (incorporated by reference to Exhibit 4.15 to the Company’s Annual Report on Form 20-F filed with the SEC on October 22, 2020)
4.16	Investigator Initiated Clinical Trial Agreement with Kazia Therapeutics Limited Agreement dated as 18 September 2020 (incorporated by reference to Exhibit 4.16 to the Company’s Annual Report on Form 20-F filed with the SEC on October 22, 2020)
4.17	Global Coalition for Adaptive Research, (“GCAR”) Clinical trial collaboration and supply agreement dated as 15 October 2020 (incorporated by reference to Exhibit 4.17 to the Company’s Annual Report on Form 20-F filed with the SEC on October 22, 2020)
4.18*✓	Development and Commercialisation Licence Agreement between Kazia Therapeutics Limited and Oasmia Pharmaceutical AB, dated March 1, 2021.
4.19*✓	License Agreement between Kazia Therapeutics Limited and Simcere Pharmaceutical Co., Ltd., dated March 29, 2021.
4.20*✓	License Agreement between Kazia Therapeutics Limited and Evotec (France) SAS, dated April 19, 2021
8.1	Company Subsidiaries (incorporated by reference to Exhibit 8.1 to the Company’s Annual Report on Form 20-F filed with the SEC on October 24, 2018 (File No. 0-29962)).
12.1*	Certification of Chief Executive Officer pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934, as amended.
12.2*	Certification of Director of Finance and Administration pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934, as amended.
13.1*	Certification of Chief Executive Officer and the Director of Finance and Administration pursuant to 18 U.S.C. Section 1350 as adopted pursuant to section 906 of the Sarbanes-Oxley Act of 2002.
15.1*	Consent of Independent Registered Public Accounting Firm.
101.INS*	XBRL Instance Document
101.SCH*	XBRL Taxonomy Extension Schema Document
101.CAL*	XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF*	XBRL Taxonomy Extension Definition Linkbase Document
101.LAB*	XBRL Taxonomy Extension Label Linkbase Document
101.PRE*	XBRL Taxonomy Extension Presentation Linkbase Document
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

* Filed herewith

✓ Certain confidential information in this exhibit was omitted by means of marking such information with brackets (“[***]”) because the identified confidential information is not material and is the type that the registrant treats as private or confidential.

52

SIGNATURES

The registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this Annual Report on its behalf.

KAZIA THERAPEUTICS LIMITED

/s/ James Garner

Dr James Garner

Managing Director and Chief Executive Officer

Date: October 7, 2021

53

Index to Financial Statements

	Page
Consolidated Financial Statements for June 30, 2021, 2020 and 2019 and the years then ended:
Report of Independent Registered Public Accounting Firm		F-2
Consolidated Statement of Profit or Loss and Other Comprehensive Income		F-3
Consolidated Statement of Financial Position		F-5
Consolidated Statement of Changes in Equity		F-6
Consolidated Statement of Cash Flows		F-8
Notes to Consolidated Financial Statements		F-9

F-1

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

Board of Directors and Shareholders

Kazia Therapeutics Limited

Opinion on the financial statements

We have audited the accompanying consolidated statements of financial position of Kazia Therapeutics Limited and subsidiaries (the “Company”) as of June 30, 2021 and 2020, the related consolidated statements of profit or loss and other comprehensive income, changes in shareholders’ equity, and cash flows for each of the three years in the period ended June 30, 2021, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of June 30, 2021 and 2020, and the results of its operations and its cash flows for each of the three years in the period ended June 30, 2021, in conformity with International Financial Reporting Standards, as issued by the International Accounting Standards Board.

Basis for opinion

These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

Critical audit matters

The critical audit matters communicated below are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.

Intangible asset impairment (Note 2, Note 3, Note 12)

The Company carries in its statement of financial position intangible assets relating to:

• the Licensing Agreement which grants the Company the right to develop the paxalisib molecule; and

• the Licensing Agreement which grants the Company the right to develop the EVT801 molecule.

The paxalisib Licensing Agreement has a carrying value of $11.3m and the EVT801 Licensing Agreement has a carrying value of $10.7m. These assets are being amortised over the remaining life of the underlying patents at acquisition date, being 15 years and 12.5 years respectively.

IAS 36 Impairment of Assets requires an entity to assess at the end of each reporting period whether there is any indication that an asset may be impaired. If any indication exists, the entity shall estimate the recoverable amount of the asset.

This is a critical audit matter due to the materiality of amounts in question and the high degree of management judgement required in assessing whether there are indicators of impairment.

Our procedures included, amongst others:

• obtaining an understanding of and evaluating management’s process and controls related to the assessment of the existence of impairment indicators;

• testing management’s assessment of the existence of any impairment indicators, including making enquiries of management’s experts;

• considering each of the internal and external factors outlined by IAS 136 and assessing whether any indicators of impairment are present;

• testing management’s assessment of the potential impact of COVID-19 on the performance of the assets; and

• evaluating the adequacy of the relevant disclosures in the financial statements.

Asset acquisition accounting (Note 2, Note 3, Note 12, and Note 15)

On 19 April 2021 the Company entered into a worldwide exclusive licensing agreement with Evotec SE, for the oncology drug candidate EVT801.

The transaction has been accounted for as an asset acquisition and as noted in note 15, the agreement contains contingent payments dependent on the achievement of contracted milestones. Management has exercised judgement in determining the probability of achieving such milestones and the timing of each. The estimated contingent consideration at 30 June 2021 is $11.08m.

This is a critical audit matter due to the materiality of amounts in question and the high degree of management judgement required.

Our procedures included, amongst others:

• obtaining and testing the license agreement to understand the terms and conditions of the transaction;

• testing management’s assessment of the proposed accounting treatment of the transaction;

• agreeing key terms of agreements utilised in management’s assessment;

• testing key assumptions made by management in its assessment of accounting treatment;

• evaluating management’s method of amortisation;

• making enquiries of management’s experts; and

• evaluating the adequacy of the relevant disclosures within the financial statements.

Accounting for license agreements under IFRS 15 Revenues from Contracts with Customers (Note 2, Note 3, and Note 5)

During the year, the Company entered into the following transactions:

• On 1 March 2021, the Company entered into an exclusive worldwide license agreement with Oasmia Pharmaceutical AB (Oasmia), granting Oasmia the worldwide rights to develop and commercialise Cantrixil; and

• On 29 March 2021 the Company entered into a licensing agreement with Simcere Pharmaceutical Group Ltd (Simcere), granting Simcere the rights to develop and commercialise Paxalisib, in the Greater China territory.

The transactions included the receipt of upfront cash payments of US$4 million and US$7 million from Oasmia and Simcere, respectively.

This is a critical audit matter due to the materiality of the transactions and the judgement required by management in accounting for these transactions in accordance with IFRS 15 Revenue from Contracts with Customers.

Our procedures included, amongst others:

• obtaining copies of the license agreements to understand the terms and conditions of the transactions;

• evaluating management’s accounting papers documenting the accounting treatments, including in relation to the applicability of IFRS 15;

• agreeing key terms of agreements utilised in management’s assessment;

• testing key assumptions made by management in its assessment of accounting treatments;

• making enquiries of management’s experts; and

• evaluating the adequacy of the relevant disclosures within the financial statements.

/s/ GRANT THORNTON AUDIT PTY LTD

GRANT THORNTON AUDIT PTY LTD

Chartered Accountants

We have served as the Company’s auditor since 2012.

Sydney, Australia

October 7, 2021

F-2

Consolidated statements of profit or loss and other comprehensive income

For the year ended 30 June 2021

	Note		2021 A$’000			2020 A$’000			2019 A$’000
Revenue from continuing operations		5		15,183			—			—
Other income		6		2			995			1,465
Finance income — bank interest				42			66			100
Expenses
Research and development expense				(14,541	)		(9,494	)		(6,475	)
General and administrative expense				(7,022	)		(3,690	)		(3,785	)
Loss on disposal of fixed assets				—			—			(1	)
Fair value losses on financial assets at fair value through profit or loss				—			(168	)		(1,809	)
Loss on revaluation of contingent consideration				(2,570	)		(474	)		(63	)
Loss before income tax expense from continuing operations				(8,906	)		(12,765	)		(10,568	)
Income tax benefit		8		484			298			298
Loss after income tax expense for the year				(8,422	)		(12,467	)		(10,270	)
Other comprehensive income
Items that may be reclassified subsequently to profit or loss
Net exchange difference on translation of financial statements of foreign controlled entities, net of tax				2			(4	)		(89	)
Other comprehensive income for the year, net of tax				2			(4	)		(89	)
Total comprehensive income for the year				(8,420	)		(12,471	)		(10,359	)
Loss for the year is attributable to:
Owners of Kazia Therapeutics Limited				(8,422	)		(12,467	)		(10,270	)
Total loss for the year				(8,422	)		(12,467	)		(10,270	)
Total comprehensive income for the year is attributable to:
Owners of Kazia Therapeutics Limited				(8,420	)		(12,471	)		(10,359	)
Total comprehensive income for the year				(8,420	)		(12,471	)		(10,359	)

The above consolidated statements of profit or loss or other comprehensive income should be read with the accompanying notes

F-3

Consolidated statements of profit or loss and other comprehensive income (continued)

For the year ended 30 June 2021

	Note		2021			2020			2019
			A$			A$			A$
			Cents			Cents			Cents
Earnings per share for loss from continuing operations attributable to the owners of Kazia Therapeutics Limited
Basic earnings per share		31		(7.16	)		(17.07	)		(17.86	)
Diluted earnings per share		31		(7.16	)		(17.07	)		(17.86	)
			2021			2020			2019
			A$			A$			A$
			Cents			Cents			Cents
Earnings per share for loss attributable to the owners of Kazia Therapeutics Limited
Basic earnings per share		31		(7.16	)		(17.07	)		(17.86	)
Diluted earnings per share		31		(7.16	)		(17.07	)		(17.86	)

F-4

Consolidated statements of financial position

As at 30 June 2021

	Note		2021 A$’000			2020 A$’000
Assets
Current assets
Cash and cash equivalents		9		27,587			8,764
Trade and other receivables		10		84			1,352
Other		11		1,720			537
Total current assets				29,391			10,653
Non-current assets
Trade and other receivables		10		6,694			—
Intangibles		12		22,003			12,410
Total non-current assets				28,697			12,410
Total assets				58,088			23,063
Liabilities
Current liabilities
Trade and other payables		13		4,933			3,489
Employee benefits		14		229			191
Contingent consideration		15		3,165			1,387
Total current liabilities				8,327			5,067
Non-Current liabilities
Deferred tax		16		2,928			3,413
Employee benefits		14		55			—
Contingent consideration		15		8,927			458
Total non-current liabilities				11,910			3,871
Total liabilities				20,237			8,938
Net assets				37,851			14,125
Equity
Contributed equity		17		80,290			48,781
Other contributed equity		18		464			464
Reserves		19		1,301			1,066
Accumulated losses				(44,204	)		(36,186	)
Equity attributable to the owners of Kazia Therapeutics Limited				37,851			14,125
Total equity				37,851			14,125

The above consolidated statements of financial position should be read with the accompanying notes

F-5

Statements of changes in equity

For the year ended 30 June 2021

	Contributed equity A$’000			Other Contributed equity A$’000		Reserves A$’000			Accumulated Losses A$’000			Non- controlling Interest A$’000		Total equity A$’000
Balance at 1 July 2018		31,576			464		1,843			(14,641	)		—		19,242
Adjustment for change in accounting policy		—			—		37			(37	)		—		—
Balance at 1 July 2018 – restated		31,576			464		1,880			(14,678	)		—		19,242
Loss after income tax expense for the year		—			—		—			(10,270	)		—		(10,270	)
Other comprehensive income for the year, net of tax		—			—		(89	)		—			—		(89	)
Total comprehensive income for the year		—			—		(89	)		(10,270	)		—		(10,359	)
Transactions with owners in their capacity as owners:
Share issue costs		(340	)		—		—			—			—		(340	)
Transfers		—			—		—			—			—		—
Share based payment		—			—		246			—			—		246
Issue of shares		5,406			—		—			—			—		5,406
Balance at 30 June 2019		36,642			464		2,037			(24,948	)		—		14,195
	Contributed equity A$’000			Other Contributed equity A$’000		Reserves A$’000			Accumulated Losses A$’000			Non- controlling Interest A$’000		Total equity A$’000
Balance at 1 July 2019		36,642			464		2,037			(24,948	)		—		14,195
Loss after income tax expense for the year		—			—		—			(12,467	)		—		(12,467	)
Other comprehensive income for the year, net of tax		—			—		(4	)		—			—		(4	)
Total comprehensive income for the year		—			—		(4	)		(12,467	)		—		(12,471	)
Transactions with owners in their capacity as owners:
Share issue costs		(833	)		—		—			—			—		(833	)
Transfers		—			—		—			—			—		—
Conversion of convertible note		—			—		—			—			—		—
Employee share-based payment options		—			—		—			—			—		—
Share based payment		—			—		262			—			—		262
Issue of shares		12,972			—		—			—			—		12,972
Expired options		—			—		(1,230	)		1,230			—		—
Balance at 30 June 2020		48,781			464		1,066			(36,186	)		—		14,125

F-6

Statements of changes in equity (continued)

For the year ended 30 June 2021

	Contributed equity A$’000			Other Contributed equity A$’000		Reserves A$’000			Accumulated Losses A$’000			Non- controlling Interest A$’000		Total equity A$’000
Balance at 1 July 2020		48,781			464		1,066			(36,186	)		—		14,125
Loss after income tax expense for the year		—			—		—			(8,422	)		—		(8,422	)
Other comprehensive income for the year, net of tax		—			—		2			—			—		2
Total comprehensive income for the year		—			—		2			(8,422	)		—		(8,420	)
Transactions with owners in their capacity as owners:
Contributions of equity, net of transaction costs		32,909			—		—			—			—		32,909
Share issue costs		(1,673	)		—		—			—			—		(1,673	)
Transfers		—			—		—			—			—		—
Conversion of convertible note		—			—		—			—			—		—
Employee share-based payment options		—			—		—			—			—		—
Share based payment		—			—		637			—			—		637
Issue of shares		273			—		(80	)		80			—		273
Expired options		—			—		(323	)		323			—		—
Balance at 30 June 2021		80,290			464		1,301			(44,204	)		—		37,851

The above consolidated statements of changes in equity should be read with the accompanying notes

F-7

Consolidated statements of cash flows

For the year ended 30 June 2021

	Note		2021 A$’000			2020 A$’000			2019 A$’000
Cash flows from operating activities
Loss before income tax expense for the year				(8,422	)		(12,467	)		(10,270	)
Adjustments for:
Depreciation and amortisation		7		1,265			1,084			1,084
Net loss on disposal of non-current assets				—			—			—
Impairment of property, plant and equipment				—			—			1
Share-based payments				637			262			246
Foreign exchange differences				430			—			—
Loss/(gain) on contingent consideration		15		2,570			474			63
Fair value loss on financial assets				—			168			1,809
				(3,521	)		(10,479	)		(7,067	)
Change in operating assets and liabilities:
Increase in trade and other receivables				(5,027	)		358			825
Increase/(decrease) in prepayments				(1,182	)		(168	)		398
Increase/(decrease) in trade and other payables				1,010			1,722			(409	)
Increase/(decrease) in other provisions				93			55			(25	)
Decrease in deferred tax liability				(484	)		(298	)		(298	)
Increase/(decrease) in accrued revenue				—			—			(138	)
Net cash used in operating activities				(9,111	)		(8,810	)		(6,714	)
Cash flows from investing activities
Proceeds from disposal of shares				—			—			2,359
Net cash used in investing activities				—			—			2,359
Cash flows from financing activities
Proceeds from issue of shares		17		28,109			12,139			3,816
Net cash from financing activities				28,109			12,139			3,816
Net decrease in cash and cash equivalents				18,998			3,329			(539	)
Cash and cash equivalents at the beginning of the financial year				8,764			5,434			5,956
Effects of exchange rate changes on cash				(175	)		—			17
Cash and cash equivalents at the end of the financial year		9		27,587			8,764			5,434

The above consolidated statements of changes in equity should be read with the accompanying notes

F-8

Notes to the financial statements

June 30, 2021

Note 1. General information

The financial statements cover Kazia Therapeutics Limited as a consolidated entity consisting of Kazia Therapeutics Limited and its subsidiaries. The financial statements are presented in Australian dollars, which is Kazia Therapeutics Limited’s functional and presentation currency.

Kazia Therapeutics Limited is a listed public company limited by shares, incorporated and domiciled in Australia. Its registered office and principal place of business is:

Three International Towers

Level 24, 300 Barangaroo Avenue

Sydney NSW 2000

The financial statements were authorised for issue, in accordance with a resolution of Directors, on 7 October 2021. The Directors have the power to amend and reissue the financial statements.

Note 2. Significant accounting policies

The principal accounting policies adopted in the preparation of the financial statements are set out below. These policies have been consistently applied to all the years presented, unless otherwise stated.

New or amended Accounting Standards and Interpretations adopted

The consolidated entity has adopted all of the new, revised or amending Accounting Standards and Interpretations issued by the International Accounting Standards Board (‘IASB’) that are mandatory for the current reporting period.

The adoption of these Accounting Standards and Interpretations did not have any significant impact on the financial performance or position of the consolidated entity. Any new, revised or amending Accounting Standards or Interpretations that are not yet mandatory have not been early adopted.

New Accounting Standards and Interpretations not yet mandatory or early adopted

Australian Accounting Standards and Interpretations that have recently been issued or amended but are not yet mandatory, have not been early adopted by the consolidated entity for the annual reporting period ended 30 June 2021. The consolidated entity’s assessment of the impact of these new or amended Accounting Standards and Interpretations is that none are deemed to have a material impact on the entity.

Going concern

The consolidated entity incurred a loss after income tax of $8,421,960 (2020: $12,467,466), was in a net current asset position of $21,064,264(2020: net current asset position of $5,586,128) and had net cash outflows from operating activities of $9,110,516(2020: $8,809,519) for the year ended 30 June 2021.

As at 30 June 2021 the consolidated entity had cash in hand and at bank of $27,586,760.

The financial statements have been prepared on a going concern basis, which contemplates continuity of normal activities and realisation of assets and settlement of liabilities in the normal course of business. As is often the case with drug development companies, the ability of the consolidated entity to continue its development activities as a going concern is dependent upon it deriving sufficient cash from investors, from licensing and partnering activities, and from other sources of revenue such as grant funding.

The directors have considered the cash flow forecasts and the funding requirements of the business and continue to explore grant funding, licensing opportunities and equity investment opportunities in the Company. In particular, the directors have considered the impact of COVID-19 on the operations of the Company, and make the following observations:

• Kazia’s key clinical trials have not been impacted by COVID-19 to date. The GBM Agile study, the pivotal study for paxalisib in glioblastoma, is on track with recruitment running to plan, and no disruption to this schedule is foreseen. The Phase II study of paxalisib in glioblastoma was fully recruited prior to the onset of restrictions and is in wrap up stage at the date of this report. Plans are on track for the commencement of a Phase I trial for EVT801 before the end of 2021;

F-9

Notes to the financial statements

June 30, 2021

Note 2. Significant accounting policies (continued)

• In general, clinical research in advanced cancer is relatively protected from pandemic disruption due to the ongoing and time-critical need for patient care in specialised facilities that cannot easily be repurposed;

• The Company is not reliant on ongoing revenue from customers, and so changes in customer behaviour over the next several years due to public health restrictions and reduced economic activity have little to no impact on its finances;

• The Company was able to secure funding of approximately $9 million at the height of the initial wave of COVID-19 in April 2020, and additional funds of approximately $25 million during the 2021 financial year;

• Based on budgets and forecasts, the Company has sufficient cash to fund the operations for a period of at least 12 months from the date of this report; and

• As a consequence the directors do not foresee any other impacts on the Company’s ability to raise additional funding as a result of COVID-19.

Accordingly the directors have prepared the financial statements on a going concern basis. Should the above assumptions not prove to be appropriate, there is material uncertainty whether the consolidated entity will continue as a going concern and therefore whether it will realise its assets and extinguish its liabilities in the normal course of business and at the amounts stated in these financial statements.

Basis of preparation

These general purpose financial statements have been prepared in accordance with Australian Accounting Standards and Interpretations issued by the Australian Accounting Standards Board (‘AASB’) and the Corporations Act 2001, as appropriate for for-profit oriented entities. These financial statements also comply with International Financial Reporting Standards as issued by the International Accounting Standards Board (‘IASB’).

The financial statements have been prepared on an accruals basis and under the historical cost conventions, except for listed equity investments which are carried at fair value.

Critical accounting estimates

The preparation of the financial statements requires the use of certain critical accounting estimates. It also requires management to exercise its judgement in the process of applying the consolidated entity’s accounting policies. The areas involving a higher degree of judgement or complexity, or areas where assumptions and estimates are significant to the financial statements, are disclosed in note 3.

Parent entity information

In accordance with the Corporations Act 2001, these financial statements present the results of the consolidated entity only. Supplementary information about the parent entity is disclosed in note 28.

Principles of consolidation

The consolidated financial statements incorporate the assets and liabilities of all subsidiaries of Kazia Therapeutics Limited (‘company’ or ‘parent entity’) as at 30 June 2021 and the results of all subsidiaries for the year then ended. Kazia Therapeutics Limited and its subsidiaries together are referred to in these financial statements as the ‘consolidated entity’.

Subsidiaries are all those entities over which the consolidated entity has control. The consolidated entity controls an entity when the consolidated entity is exposed to, or has rights to, variable returns from its involvement with the entity and has the ability to affect those returns through its power to direct the activities of the entity. Subsidiaries are fully consolidated from the date on which control is transferred to the consolidated entity. They are de-consolidated from the date that control ceases.

Intercompany transactions, balances and unrealised gains on transactions between entities in the consolidated entity are eliminated. Unrealised losses are also eliminated unless the transaction provides evidence of the impairment of the asset transferred. Accounting policies of subsidiaries have been changed where necessary to ensure consistency with the policies adopted by the consolidated entity.

F-10

Notes to the financial statements

June 30, 2021

Note 2. Significant accounting policies (continued)

The acquisition of subsidiaries is accounted for using the acquisition method of accounting. A change in ownership interest, without the loss of control, is accounted for as an equity transaction, where the difference is between the consideration transferred and the book value.

Where the consolidated entity loses control over a subsidiary, it derecognises the assets including goodwill, liabilities and non-controlling interest in the subsidiary together with any cumulative translation differences recognised in equity. The consolidated entity recognises the fair value of the consideration received and the fair value of any investment retained together with any gain or loss in profit or loss.

Operating segments

Operating segments are presented using the ‘management approach’, where the information presented is on the same basis as the internal reports provided to the Chief Operating Decision Makers (‘CODM’). The CODM is responsible for the allocation of resources to operating segments and assessing their performance. The CODM is considered to be the Board of Directors.

Foreign currency translation

The financial statements are presented in Australian dollars, which is the consolidated entity’s functional and presentation currency.

Foreign currency transactions

Foreign currency transactions are translated into Australian dollars using the exchange rates prevailing at the dates of the transactions. Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation at financial year-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognised in profit or loss.

Foreign operations

The assets and liabilities of foreign operations are translated into Australian dollars using the exchange rates at the reporting date. The revenues and expenses of foreign operations are translated into Australian dollars using the average exchange rates, which approximate the rate at the date of the transaction, for the period. All resulting foreign exchange differences are recognised in other comprehensive income through the foreign currency reserve in equity.

The foreign currency reserve is recognised in profit or loss when the foreign operation is disposed of.

Exchange differences arising on a monetary item that forms part of a reporting entity’s net investment in a foreign operation shall be recognised initially in other comprehensive income and reclassified from equity to profit or loss on disposal of the net investment.

Financial Instruments

Recognition and derecognition

Financial assets and financial liabilities are recognised when the Group becomes a party to the contractual provisions of the financial instrument and are measured initially at fair value adjusted by transactions costs, except for those carried at fair value through profit or loss, which are measured initially at fair value. Subsequent measurement of financial assets and financial liabilities are described below. Financial assets are derecognised when the contractual rights to the cash flows from the financial asset expire, or when the financial asset and substantially all the risks and rewards are transferred. A financial liability is derecognised when it is extinguished, discharged, cancelled or expires.

Classification and initial measurement of financial assets

Except for those trade receivables that do not contain a significant financing component and are measured at the transaction price in accordance with IFRS 15, all financial assets are initially measured at fair value adjusted for transaction costs (where applicable).

F-11

Notes to the financial statements

June 30, 2021

Note 2. Significant accounting policies (continued)

Subsequent measurement of financial assets

For the purpose of subsequent measurement, financial assets are classified into the following categories upon initial recognition:

• financial assets at amortised cost

• financial assets at fair value through profit or loss (FVPL)

Classifications are determined by both:

• The entity’s business model for managing the financial asset

• The contractual cash flow characteristics of the financial assets

All income and expenses relating to financial assets that are recognised in profit or loss are presented within finance costs, finance income or other financial items, except for impairment of trade receivables which is presented within other expenses.

Financial assets at amortised cost

Financial assets are measured at amortised cost if the assets meet the following conditions (and are not designated as FVPL):

• they are held within a business model whose objective is to hold the financial assets and collect its contractual cash flows

• the contractual terms of the financial assets give rise to cash flows that are solely payments of principal and interest on the principal amount outstanding

After initial recognition, these are measured at amortised cost using the effective interest method. Discounting is omitted where the effect of discounting is immaterial. The Group’s cash and cash equivalents, trade and most other receivables fall into this category of financial instruments.

Financial assets at fair value through profit or loss (FVPL)

Financial assets that are held within a business model other than ‘hold to collect’ or ‘hold to collect and sell’ are categorised at fair value through profit and loss. Further, irrespective of business model, financial assets whose contractual cash flows are not solely payments of principal and interest are accounted for at FVPL. The Group’s investments in equity instruments and derivatives fall under this category.

Impairment of financial assets

IFRS 9’s new impairment model uses more forward looking information to recognize expected credit losses—the ‘expected credit losses (ECL) model’. The application of the new impairment model depends on whether there has been a significant increase in credit risk. The Group considers a broader range of information when assessing credit risk and measuring expected credit losses, including past events, current conditions, reasonable and supportable forecasts that affect the expected collectability of the future cash flows of the instrument.

In applying this forward-looking approach, a distinction is made between:

• financial instruments that have not deteriorated significantly in credit quality since initial recognition or that have low credit risk (‘Stage 1’) and

• financial instruments that have deteriorated significantly in credit quality since initial recognition and whose credit risk is not low (‘Stage 2’).

‘Stage 3’ would cover financial assets that have objective evidence of impairment at the reporting date. ‘12-month expected credit losses’ are recognised for the first category while ‘lifetime expected credit losses’ are recognised for the second category. Measurement of the expected credit losses is determined by a probability-weighted estimate of credit losses over the expected life of the financial instrument.

F-12

Notes to the financial statements

June 30, 2021

Note 2. Significant accounting policies (continued)

Classification and measurement of financial liabilities

The Group’s financial liabilities comprise trade and other payables. Financial liabilities are initially measured at fair value, and, where applicable, adjusted for transaction costs unless the Group designated a financial liability at fair value through profit or loss. Subsequently, financial liabilities are measured at amortised cost using the effective interest method.

All interest-related charges and, if applicable, changes in an instrument’s fair value that are reported in profit or loss are included within finance costs or finance income.

Revenue from contracts with customers

Revenue is measured at the fair value of the consideration received or receivable. Amounts disclosed as revenue are net of returns, trade allowances, rebates and amounts collected on behalf of third parties. Revenue is recognised using a five step approach in accordance with IFRS 15 Revenue from Contracts with Customers to depict the transfer of promised services to customers in an amount that reflects the consideration to which the Group expects to be entitled in exchange for those services. Distinct promises within the contract are identified as performance obligations. The transaction price of the contract is measured based on the amount of consideration the consolidated entity expects to be entitled to from the customer in exchange for services. Factors such as requirements around variable consideration, significant financing components, noncash consideration, or amounts payable to customers also determine the transaction price. The transaction is then allocated to separate performance obligations in the contract based on relative standalone selling prices. Revenue is recognised when, or as, performance obligations are satisfied, which is when control of the promised service is transferred to the customer. Amounts received prior to satisfying the revenue recognition criteria are recorded as deferred revenue. Amounts expected to be recognised as revenue within the 12 months following the balance sheet date are classified within current liabilities. Amounts not expected to be recognised as revenue within the 12 months following the balance sheet date are classified within non-current liabilities.

The consolidated entity recognises contract liabilities for consideration received in respect of unsatisfied performance obligations and reports these amounts as other liabilities in its consolidated statement of financial position. Similarly, if the consolidated entity satisfies a performance obligation before it receives the consideration, the consolidated entity recognises either a contract asset or a receivable in its statement of financial position, depending on whether something other than the passage of time is required before the consideration is due.

Licensing revenues, including milestone revenue

Revenue from licensees of the consolidated entity’s intellectual property reflects the transfer of a right to use the intellectual property as it exists at the point in time in which the licence is transferred to the customer.

Licensing agreements are examined to determine whether they contain additional performance obligations, over and above the right to use the intellectual property. To the extent that additional performance obligations exist, the transaction price the consolidated entity expects to receive for the contract is allocated to the separate performance obligations.

The receipt of milestone payments is often contingent on meeting certain clinical, regulatory or commercial targets, and is therefore considered variable consideration. The transaction price of the contingent milestone is estimated using the most likely amount method. Within the transaction price, the price associated with a contingent milestone is included only to the extent that it is highly probable that a significant reversal in the amount of cumulative revenue recognized will not occur. Milestone payments that are not within the control of the Group, such as regulatory approvals, are not considered highly probable of being achieved until those approvals are achieved.

Finance Income

Interest revenue is recognised as interest accrues using the effective interest method. This is a method of calculating the amortised cost of a financial asset and allocating the interest income over the relevant period using the effective interest rate, which is the rate that exactly discounts estimated future cash receipts through the expected life of the financial asset to the net carrying amount of the financial asset.

F-13

Notes to the financial statements

June 30, 2021

Note 2. Significant accounting policies (continued)

Other revenue

Other revenue is recognised when it is received or when the right to receive payment is established.

Grant income

The R&D Tax Incentive is a government program which helps to offset some of the incurred costs of R&D. Eligible expenditure incurred under the scheme in a financial year attracts an additional 43.5% tax deduction, and for a group earning income of less than $20 million, the cash value of the additional deduction is remitted to the taxpayer. In accordance with IAS 20, as the compensation relates to expenses already incurred, it is recognised in profit or loss of the period in which it becomes receivable. Accordingly the group accounts for the R&D Tax Incentive in the same year as the expenses to which it relates.

Income tax

The income tax expense or benefit for the period is the tax payable on that period’s taxable income based on the applicable income tax rate for each jurisdiction, adjusted by changes in deferred tax assets and liabilities attributable to temporary differences, unused tax losses and the adjustment recognised for prior periods, where applicable.

Deferred tax assets and liabilities are recognised for temporary differences at the tax rates expected to apply when the assets are recovered or liabilities are settled, based on those tax rates that are enacted or substantively enacted, except for:

• When the deferred income tax asset or liability arises from the initial recognition of goodwill or an asset or liability in a transaction that is not a business combination and that, at the time of the transaction, affects neither the accounting nor taxable profits; or

• When the taxable temporary difference is associated with interests in subsidiaries, associates or joint ventures, and the timing of the reversal can be controlled and it is probable that the temporary difference will not reverse in the foreseeable future.

Deferred tax assets are recognised for deductible temporary differences and unused tax losses only if it is probable that future taxable amounts will be available to utilise those temporary differences and losses.

The carrying amount of recognised and unrecognised deferred tax assets are reviewed each reporting date. Deferred tax assets recognised are reduced to the extent that it is no longer probable that future taxable profits will be available for the carrying amount to be recovered. Previously unrecognised deferred tax assets are recognised to the extent that it is probable that there are future taxable profits available to recover the asset.

Deferred tax assets and liabilities are offset only where there is a legally enforceable right to offset current tax assets against current tax liabilities and deferred tax assets against deferred tax liabilities; and they relate to the same taxable authority on either the same taxable entity or different taxable entities which intend to settle simultaneously.

Kazia Therapeutics Limited (the ‘parent entity’) and its wholly-owned Australian controlled entities have formed an income tax consolidated group under the tax consolidation regime. Kazia Therapeutics Limited as the parent entity discloses all of the deferred tax assets of the tax consolidated group in relation to tax losses carried forward (after elimination of inter-group transactions). The tax consolidated group has applied the ‘separate taxpayer in the group’ allocation approach in determining the appropriate amount of taxes to allocate to members of the tax consolidated group.

As the tax consolidation group continues to generate tax losses there has been no reason for the company to enter a tax funding agreement with members of the tax consolidation group.

Interpretation 23 Uncertain tax positions

Interpretation 23 clarified the application of the recognition and measurement criteria IAS 12 Income Taxes where there is uncertainty over income tax treatments and requires an assessment of each uncertain tax position as to whether it is probable that a taxation authority will accept the position. Where it is not probable, the effect of the uncertainty is reflected in determining the relevant taxable profit or loss, tax bases, unused tax losses and unused tax credits or tax rates. The amount is determined as either the single most likely amount or the sum of the probability weighted amounts in a range of possible outcomes, whichever better predicts the resolution of the uncertainty. Judgments are reassessed as and when new facts and circumstances are presented.

F-14

Notes to the financial statements

June 30, 2021

Note 2. Significant accounting policies (continued)

Current and non-current classification

Assets and liabilities are presented in the statement of financial position based on current and non-current classification.

An asset is current when: it is expected to be realised or intended to be sold or consumed in normal operating cycle; it is held primarily for the purpose of trading; it is expected to be realised within 12 months after the reporting period; or the asset is cash or cash equivalent unless restricted from being exchanged or used to settle a liability for at least 12 months after the reporting period. All other assets are classified as non-current.

A liability is current when: it is expected to be settled in normal operating cycle; it is held primarily for the purpose of trading; it is due to be settled within 12 months after the reporting period; or there is no unconditional right to defer the settlement of the liability for at least 12 months after the reporting period. All other liabilities are classified as non-current.

Deferred tax assets and liabilities are always classified as non-current.

Cash and cash equivalents

Cash and cash equivalents includes cash on hand, deposits held at call with financial institutions, other short-term, highly liquid investments with original maturities of three months or less that are readily convertible to known amounts of cash and which are subject to an insignificant risk of changes in value.

Research and development

Expenditure during the research phase of a project is recognised as an expense when incurred. Development costs are capitalised only when technical feasibility studies identify that the project will deliver future economic benefits and these benefits can be measured reliably.

Leases

Under IFRS 16, leases are accounted for as follows:

• Right-of-use assets and lease liabilities are recognised in the consolidated statement of financial position, initially measured at the present value of future lease payments;

• Depreciation on right-of-use assets and interest on lease liabilities are recognised in the consolidated statement of profit or loss; and

• The total amount of cash paid under lease arrangements is separated into a principal portion (presented within financing activities) and interest (presented within operating activities) in the consolidated cash flow statement.

Lease incentives under IFRS 16 are recognised as part of the measurement of right-of-use assets and lease liabilities.

Under IFRS 16, right-of-use assets are tested for impairment in accordance with IAS 36 Impairment of assets. This replaces the previous requirement to recognise a provision for onerous lease contracts.

For short-term leases (lease term of 12 months or less) and leases of low-value assets, the consolidated entity has opted to recognise a lease expense on a straight-line basis as permitted by IFRS 16 Leases. This expense is presented within other expenses in the consolidated statement of profit or loss.

Intangible assets

Intangible assets acquired as part of a business combination, other than goodwill, are initially measured at their fair value at the date of the acquisition. Intangible assets acquired separately are initially recognised at cost. Indefinite life intangible assets are not amortised and are subsequently measured at cost less any impairment. Finite life intangible assets are subsequently measured at cost less amortisation and any impairment. The gains or losses recognised in profit or loss arising from derecognition of intangible assets are measured as the difference between net disposal proceeds and the carrying amount of the intangible asset. The method and useful lives of finite life intangible assets are reviewed annually. Changes in the expected pattern of consumption or useful life are accounted for prospectively by changing the amortisation method or period. Amortisation expense is included in research and development expenditure.

F-15

Notes to the financial statements

June 30, 2021

Note 2. Significant accounting policies (continued)

Licensing agreement for paxalisib

The Licensing Agreement asset was initially brought to account at fair value, and is being amortised on a straight-line basis over the period of its expected benefit, being the remaining life of the patent, which was 15 years from the date of acquisition.

Licensing agreement for EVT801

The Licensing agreement asset was initially brought to account at cost and is being amortised on a straight-line basis over the period of its expected benefit, being the remaining life of the patent, which was 12.5 years from the date of acquisition.

Impairment of non-financial assets

Non-financial assets with finite useful lives are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. An impairment loss is recognised for the amount by which the asset’s carrying amount exceeds its recoverable amount.

Recoverable amount is the higher of an asset’s fair value less costs of disposal and value-in-use. The value-in-use is the present value of the estimated future cash flows relating to the asset using a pre-tax discount rate specific to the asset or cash-generating unit to which the asset belongs. Assets that do not have independent cash flows are grouped together to form a cash-generating unit.

Compound financial instruments

Subsequent to initial recognition, the liability component of a compound financial instrument is measured at amortised cost using the effective interest rate method, whereas the equity component is not remeasured. Interest, gains and losses relating to the financial liability are recognised in profit or loss. On conversion, the financial liability is reclassified to equity; no gain or loss is recognised on conversion.

Provisions

Provisions are recognised when the consolidated entity has a present (legal or constructive) obligation as a result of a past event, it is probable the consolidated entity will be required to settle the obligation, and a reliable estimate can be made of the amount of the obligation. The amount recognised as a provision is the best estimate of the consideration required to settle the present obligation at the reporting date, taking into account the risks and uncertainties surrounding the obligation. If the time value of money is material, provisions are discounted using a current pre-tax rate specific to the liability. The increase in the provision resulting from the passage of time is recognised as a finance cost.

Employee benefits

Short-term employee benefits

Liabilities for wages and salaries, including non-monetary benefits, annual leave and long service leave expected to be settled within 12 months of the reporting date are measured at the amounts expected to be paid when the liabilities are settled.

Other long-term employee benefits

The liability for annual leave and long service leave not expected to be settled within 12 months of the reporting date is measured as the present value of expected future payments to be made in respect of services provided by employees up to the reporting date using the projected unit credit method. Consideration is given to expected future wage and salary levels, experience of employee departures and periods of service. Expected future payments are discounted using market yields at the reporting date on high quality corporate bonds with terms to maturity and currency that match, as closely as possible, the estimated future cash outflows.

Defined contribution superannuation expense

Contributions to defined contribution superannuation plans are expensed in the period in which they are incurred.

F-16

Notes to the financial statements

June 30, 2021

Note 2. Significant accounting policies (continued)

Share-based payments

Equity-settled share-based compensation benefits are provided to employees under the terms of the Employee Share Option Plan (‘ESOP’) and consultants as compensation for services performed.

Equity-settled transactions are awards of shares, or options over shares that are provided to employees in exchange for the rendering of services.

The cost of equity-settled transactions are measured at fair value on grant date. Fair value is independently determined using the Black-Scholes option pricing model that takes into account the exercise price, the term of the option, the impact of dilution, the share price at grant date and expected price volatility of the underlying share, the expected dividend yield and the risk free interest rate for the term of the option, together with non-vesting conditions that do not determine whether the consolidated entity receives the services that entitle the employees to receive payment. No account is taken of any other vesting conditions.

The cost of equity-settled transactions are recognised as an expense with a corresponding increase in equity over the vesting period. The cumulative charge to profit or loss is calculated based on the grant date fair value of the award, the best estimate of the number of awards that are likely to vest and the expired portion of the vesting period. The amount recognised in profit or loss for the period is the cumulative amount calculated at each reporting date less amounts already recognised in previous periods.

The cumulative charge to profit or loss until settlement of the liability is calculated as follows:

• during the vesting period, the liability at each reporting date is the fair value of the award at that date multiplied by the expired portion of the vesting period.

• from the end of the vesting period until settlement of the award, the liability is the full fair value of the liability at the reporting date.

Market conditions are taken into consideration in determining fair value. Therefore any awards subject to market conditions are considered to vest irrespective of whether or not that market condition has been met, provided all other conditions are satisfied.

If equity-settled awards are modified, as a minimum an expense is recognised as if the modification has not been made. An additional expense is recognised, over the remaining vesting period, for any modification that increases the total fair value of the share-based compensation benefit as at the date of modification.

If the non-vesting condition is within the control of the consolidated entity or employee, the failure to satisfy the condition is treated as a cancellation. If the condition is not within the control of the consolidated entity or employee and is not satisfied during the vesting period, any remaining expense for the award is recognised over the remaining vesting period, unless the award is forfeited.

If equity-settled awards are cancelled, it is treated as if it has vested on the date of cancellation, and any remaining expense is recognised immediately. If a new replacement award is substituted for the cancelled award, the cancelled and new award is treated as if they were a modification.

Finance costs

Finance costs attributable to qualifying assets are capitalised as part of the asset. All other finance costs are expensed in the period in which they are incurred, including interest on short-term and long-term borrowings.

Fair value measurement

When an asset or liability, financial or non-financial, is measured at fair value for recognition or disclosure purposes, the fair value is based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date; and assumes that the transaction will take place either: in the principal market; or in the absence of a principal market, in the most advantageous market.

F-17

Notes to the financial statements

June 30, 2021

Note 2. Significant accounting policies (continued)

Fair value is measured using the assumptions that market participants would use when pricing the asset or liability, assuming they act in their economic best interest. For non-financial assets, the fair value measurement is based on its highest and best use. Valuation techniques that are appropriate in the circumstances and for which sufficient data are available to measure fair value, are used, maximising the use of relevant observable inputs and minimising the use of unobservable inputs.

Assets and liabilities measured at fair value are classified, into three levels, using a fair value hierarchy that reflects the significance of the inputs used in making the measurements. Classifications are reviewed each reporting date and transfers between levels are determined based on a reassessment of the lowest level input that is significant to the fair value measurement.

For recurring and non-recurring fair value measurements, external valuers may be used when internal expertise is either not available or when the valuation is deemed to be significant. External valuers are selected based on market knowledge and reputation. Where there is a significant change in fair value of an asset or liability from one period to another, an analysis is undertaken, which includes a verification of the major inputs applied in the latest valuation and a comparison, where applicable, with external sources of data.

Issued capital

Ordinary shares are classified as equity.

Incremental costs directly attributable to the issue of new shares or options, including share based payments relating to the issue of shares are, shown in equity as a deduction, net of tax, from the proceeds.

Earnings per share

Basic earnings per share

Basic earnings per share is calculated by dividing the profit attributable to the owners of Kazia Therapeutics Limited, excluding any costs of servicing equity other than ordinary shares, by the weighted average number of ordinary shares outstanding during the financial year, adjusted for bonus elements in ordinary shares issued during the financial year.

Diluted earnings per share

Diluted earnings per share adjusts the figures used in the determination of basic earnings per share to take into account the after income tax effect of interest and other financing costs associated with dilutive potential ordinary shares and the weighted average number of shares assumed to have been issued for no consideration in relation to dilutive potential ordinary shares.

Goods and Services Tax (‘GST’) and other similar taxes

Revenues, expenses and assets are recognised net of the amount of associated GST, unless the GST incurred is not recoverable from the tax authority. In this case it is recognised as part of the cost of the acquisition of the asset or as part of the expense.

Receivables and payables are stated inclusive of the amount of GST receivable or payable. The net amount of GST recoverable from, or payable to, the tax authority is included in other receivables or other payables in the statement of financial position.

Cash flows are presented on a gross basis. The GST components of cash flows arising from investing or financing activities which are recoverable from, or payable to the tax authority, are presented as operating cash flows.

Commitments and contingencies are disclosed net of the amount of GST recoverable from, or payable to, the tax authority.

Note 3. Critical accounting judgements, estimates and assumptions

The preparation of the financial statements requires management to make judgements, estimates and assumptions that affect the reported amounts in the financial statements. Management continually evaluates its judgements and estimates in relation to assets, liabilities, contingent liabilities, revenue and expenses. Management bases its judgements, estimates and assumptions on historical experience and on other various factors, including expectations of future events, management believes to be reasonable under the circumstances. The resulting accounting judgements and estimates will seldom equal the related actual results. The judgements, estimates and assumptions that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities (refer to the respective notes) within the next financial year are discussed as follows:

F-18

Notes to the financial statements

June 30, 2021

Note 3. Critical accounting judgements, estimates and assumptions (continued)

Research and development expenses

The Directors do not consider the development programs to be sufficiently advanced to reliably determine the economic benefits and technical feasibility to justify capitalisation of development costs. These costs have been recognised as an expense when incurred.

Research and development expenses relate primarily to the cost of conducting human clinical and pre-clinical trials. Clinical development costs are a significant component of research and development expenses. Estimates have been used in determining the expense liability under certain clinical trial contracts where services have been performed but not yet invoiced. Generally the costs, and therefore estimates, associated with clinical trial contracts are based on the number of patients, drug administration cycles, the type of treatment and the outcome being measured. The length of time before actual amounts can be determined will vary depending on length of the patient cycles and the timing of the invoices by the clinical trial partners.

Revenue recognition

The consolidated entity applies judgement in determining whether contracts entered into fall within the scope of IFRS 15 Revenue from Contracts with Customers. In doing so, management considers the commercial substance of the transaction and how risks and benefits of the contract accrue to the various parties to the contract. In determining the accounting treatment of the contracts with each customer, management assessed that the contracts were within the scope of IFRS 15 ‘Revenue from Contracts with Customers’. Management has also made the judgement in each case that the grant of the licence and transfer of associated know-how and materials are accounted for as one performance obligation as they are not considered to be distinct; they are highly interrelated and could not provide benefits to the customer independently from each other. Judgements were also made in relation to the transfer of the licence and know-how in each case, and whether this should be recognised over time or a point in time. The point in time has been determined with regard to the point at which the transfer of know-how has substantially been completed and the customer has control of the asset and the ability to direct the use of and receive substantially all of the remaining benefits.

Clinical trial expenses

The timing of payment for work conducted under clinical trials often bears little relation to the timing of the work effort. Detailed estimates are made to determine the amount of work effort expended during a reporting period in order to determine the appropriate expense to be recognised, with the resulting prepayments or un-invoiced amounts being recognised as a prepayment or an accrual respectively.

Share-based payment transactions

The consolidated entity measures the cost of equity-settled transactions with employees by reference to the fair value of the equity instruments at the date at which they are granted. The fair value is determined by using the Black-Scholes option pricing model taking into account the terms and conditions upon which the instruments were granted. The accounting estimates and assumptions relating to equity-settled share-based payments would have no impact on the carrying amounts of assets and liabilities within the next annual reporting period but may impact profit or loss and equity.

Acquisition of intangible assets

The consolidated entity has applied judgement in determining the accounting treatment for the acquisition of the License agreement for EVT801. The License agreement has been determined to be a stand alone transaction, independent from any other agreements which have been or may be entered into with Evotec (France) SAS. Management has also made the decision to account for the cost of the asset conferred by the License agreement on the basis of the milestones that are probable of being payable, that is, those for which there is judged to be a probability of greater than 50% that the milestone will be triggered.

Contingent consideration

Contingent consideration relates to the intangible assets acquired, and the fair value of contingent consideration is dependent on the key assumptions used in accounting for the acquisition of those intangible assets. These assumptions include the probability of milestones occurring, and can also include the anticipated timing of settlement and discount rates used.

F-19

Notes to the financial statements

June 30, 2021

Note 3. Critical accounting judgements, estimates and assumptions (continued)

In the case where contingent consideration is recognised on the basis that the liability is probable of occurring, judgement is used in determining which milestones are considered probable of being triggered.

Intangible assets available for use

The consolidated entity has exercised judgement in determining that its intangible assets, being license agreements, have a finite life and are available for use once acquired. As the business model is to acquire such assets and then develop them to generate returns from future license transactions or other means, management have determined that the assets are available for use from the time that they are acquired. In each case the prima facie useful life is the remaining life of the patent over the asset, unless other factors over-ride this assessment.

Impairment of non-financial assets other than goodwill and other indefinite life intangible assets

The consolidated entity assesses impairment of non-financial assets other than goodwill and other indefinite life intangible assets at each reporting date by evaluating conditions specific to the consolidated entity and to the particular asset that may lead to impairment. Judgement is used to determine whether any indicators of impairment exist, and reference is made to the considerations included in IAS 36 Impairment of Assets in this assessment. If an impairment trigger is found to exist, the recoverable amount of the asset is determined.

Note 4. Operating segments

Identification of reportable operating segments

The consolidated entity’s operating segment is based on the internal reports that are reviewed and used by the Board of Directors (being the Chief Operating Decision Makers (‘CODM’)) in assessing performance and in determining the allocation of resources.

The consolidated entity operates in the pharmaceutical research and development business. There are no operating segments for which discrete financial information exists.

The information reported to the CODM, on at least a quarterly basis, is the consolidated results as shown in the statement of profit or loss and other comprehensive income and statement of financial position.

Major customers

During the year the consolidated entity transacted with two customers, and revenue from each customer amounted to in excess of 10% of the total revenue from the period. Both companies entered into license agreements for the consolidated entity’s drug assets.

Note 5. Revenue

	Consolidated
	2021 A$’000		2020 A$’000		2019 A$’000
Licensing revenue		15,183		—		—

Disaggregation of revenue

The disaggregation of revenue from contracts with customers is as follows:

	Consolidated
	2021 A$’000		2020 A$’000		2019 A$’000
Geographical regions
China		10,006		—		—
Sweden		5,177		—		—
		15,183		—		—
Timing of revenue recognition
Licensing revenue at a point in time		15,183		—		—

F-20

Notes to the financial statements

June 30, 2021

Note 6. Other income

	Consolidated
	2021 A$’000		2020 A$’000		2019 A$’000
Net foreign exchange gain		—		5		—
Payroll tax rebate		2		2		—
Subsidies and grants		—		20		9
Reimbursement of expenses		—		—		25
Research and development rebate		—		968		1,431
Other income		2		995		1,465

Note 7. Expenses

	Consolidated
	2021		2020		2019
	A$’000		A$’000		A$’000
Loss before income tax includes the following specific
Amortisation
Paxalisib licensing agreement		1,084		1,084		1,084
Evotech licensing agreement		181		—		—
Total amortisation		1,265		1,084		1,084
Net foreign exchange loss
Net foreign exchange loss		430		—		18
Rental expense relating to operating leases
Minimum lease payments		93		108		79
Superannuation expense
Defined contribution superannuation expense		138		140		128
Employee benefits expense excluding superannuation
Employee benefits expense excluding superannuation		1,563		1,526		1,396
Other Expenses
Chinese With-Holding Tax incurred on license transaction		931		—		—
Chinese Value Added Tax incurred on license transaction		538		—		—
		1,469		—		—

F-21

Notes to the financial statements

June 30, 2021

Note 8. Income tax benefit

	2021			2020			2019
	A$’000			A$’000			A$’000
Numerical reconciliation of income tax benefit and tax at the statutory rate
Loss before income tax benefit		(8,906	)		(12,765	)		(10,568	)
Tax at the statutory tax rate of 26% (2020 & 2019 27.5%)		(2,316	)		(3,511	)		(2,906	)
Tax effect amounts which are not deductible/(taxable) in calculating taxable income:
Research and Development claim		—			280			394
Amortisation of intangibles		348			298			—
Employee option plan		175			72			67
Gain/loss on revaluation of contingent consideration		707			131			17
		(1,086	)		(2,730	)		(2,428	)
Adjustment to deferred tax balances as a result of change in statutory tax rate		(186	)		—			—
Tax losses and timing differences not recognised		788			2,432			2,130
Income tax benefit		(484	)		(298	)		(298	)
	2021			2020			2019
	A$’000			A$’000			A$’000
Tax losses not recognised
Unused tax losses for which no deferred tax asset has been recognised-Australia		70,896			67,430			57,050
Potential tax benefit @ 26.0% (2020 27.5%)- Australia		18,433			17,531			15,689
Unused tax losses for which no deferred tax asset has been recognised-US		2,038			1,570			2,366
Potential tax benefit at statutory tax rates@21%-US		428			330			497

Note 9. Current assets - cash and cash equivalents

	2021		2020
	A$’000		A$’000
Cash at bank and on hand		21,087		1,264
Short-term deposits		6,500		7,500
		27,587		8,764

Note 10. Trade and other receivables

	2021		2020
	A$’000		A$’000
Current assets
R&D tax rebate receivable		—		1,017
		—		1,017
Other receivables		76		177
Deposits held		8		567
Less: Provision for impairment of deposits held		—		(409	)
		84		1,352
Non-current assets
Deposit paid		6,694
		6,778		1,352

F-22

Notes to the financial statements

June 30, 2021

Note 10. Trade and other receivables (continued)

Of the deposit paid, $6.65m represents an advance to GCAR at the start of the GBM Agile trial, and is refundable if not utilised against trial expenses. The amount will be allocated against expenditure towards the latter end of the trial, which is expected to be over 12 months from year end.

Note 11. Other assets

Current assets

	2021		2020
	A$’000		A$’000
Prepayments		1,720		537

Note 12. Intangibles

Non-current assets

	Consolidated
	2021			2020
	A$’000			A$’000
Licensing agreement - at acquired fair value		16,408			16,408
Less: Accumulated amortisation		(5,082	)		(3,998	)
		11,326			12,410
Licensing agreement - at cost		10,858			—
Less: Accumulated amortisation		(181	)		—
		10,677			12,410
		22,003			12,410

Reconciliations

Reconciliations of the written down values at the beginning and end of the current and previous financial year are set out below:

	EVT801 licensing agreement A$’000			Paxalisib licensing agreement A$’000			Total A$’000
Balance at 1 July 2019		—			13,494			13,494
Additions
Disposals
Amortisation expense		—			(1,084	)		(1,084	)
Balance at 30 June 2020		—			12,410			12,410
Additions		10,858						10,858
Amortisation expense		(181	)		(1,084	)		(1,265	)
Balance at 30 June 2021		10,677			11,326			22,003

During the financial year the consolidated entity acquired exclusive rights to EVT801, a small-molecule selective inhibitor of vascular endothelial growth factor receptor 3 (VEGFR3).

F-23

Notes to the financial statements

June 30, 2021

Note 13. Trade and other payables

	2021		2020
	A$’000		A$’000
Trade payables		1,893		1,694
Accrued payables		3,040		1,795
		4,933		3,489

Refer to note 21 for further information on financial instruments.

Note 14. Employee benefits

	2021		2020
	A$’000		A$’000
Current Liabilities
Employee benefits		229		191
Non-Current Liabilities
Long service leave		55		—
		284		191

Note 15. Contingent consideration

	2021 A$’000		2020 A$’000
Current Liabilities
Contingent consideration - paxalisib		—		1,387
Contingent consideration – EVT801		3,165		—
		3,165		1,387
Non-current Liabilities
Contingent consideration - paxalisib		1,015		458
Contingent consideration – EVT801		7,911		—
		8,927		458
		12,091		1,845

Contingent consideration - paxalisib

During the 2017 financial year, the consolidated entity acquired 100% of the issued shares in Glioblast Pty Ltd, a privately-held, neuro-oncology-focused Australian biotechnology company. On the same day, Kazia entered into a worldwide licensing agreement with Genentech to develop and commercialise GDC-0084, now known as paxalisib.

The Glioblast acquisition contains four contingent milestone payments, the first two milestone payments are to be settled with Kazia shares, and the third and fourth milestone payments are to be settled with either cash or Kazia shares at the discretion of Kazia. Milestones 1 and 4 have now been paid out, and Milestone 3 has lapsed. Milestone 2 comprises shares to the value of $1,250,000.

The Genentech agreement comprises of one milestone payment payable on the first commercial licensed product sale, in the amount of $1,394,000.

F-24

Notes to the financial statements

June 30, 2021

Note 15. Contingent consideration (continued)

Each milestone payment is probability weighted for valuation purposes. The milestone payments are discounted to present value, using a discount rate of 15% (previously 35%) per annum. The discount rate was considered at 30 June 2021 and it was determined that the risk of the asset, and therefore of the milestones being met, has been considerably decreased as a result of paxalisib entering the pivotal GBM Agile trial, which is progressing well, and the license transaction with Simcere Pharmaceutical Group, which provides an external validation of paxalisib. Accordingly, the discount rate applied to future expected cash flows has been revised downwards.

Kazia is also required to pay royalties to Genentech in relation to net sales. These payments are related to future financial performance, and are not considered as part of the consideration in relation to the Genentech agreement.

Contingent consideration - EVT801

As set out in note 2, the acquisition of EVT801 has been accounted for at cost, with milestones where the payment is considered probable being booked as a current or non-current liability at year end, according to the estimated payment date. Milestones where the payment is not considered probable at year end have not been accounted for as a liability. The total amount of milestone payments not booked at year end amounts to €300,500,000 ($475,474,684).

Note 16. Deferred tax

	2021		2020
	A$’000		A$’000
Non-current Liabilities
Deferred tax liability associated with Licensing Agreement		2,928		3,413

Note 17. Equity - contributed equity

	Consolidated
	2021 Shares		2020 Shares		2021 $		2020 $
Ordinary shares - fully paid		132,012,209		94,598,369		80,290,062		48,781,214

Movements in Ordinary share capital

Details	Date	Shares		Issue price		$
Balance	1 July 2019		62,166,673				36,641,519
Share placement	1 November 2019		10,000,000	$	0.400		4,000,000
Share placement	16 April 2020		18,041,667	$	0.400		7,216,667
Issued under the Share Purchase Plan	11 May 2020		4,390,010	$	0.400		1,756,004
Issued on conversion of options			19	$	4.000		76
Share issue transaction costs			—	$	0.000		(833,052	)
Balance	30 June 2020		94,598,369				48,781,214
Issued on conversion of options	28 August 2020		25,000	$	0.493		12,313
Institutional placement under ANREO	12 October 2020		20,525,820	$	0.800		16,420,656
Retail placement under ANREO	26 October 2020		11,017,075	$	0.800		8,813,660
Issued on conversion of options	2 March 2021		391,500	$	0.635		248,661
Issued on conversion of options	15 March 2021		25,000	$	0.493		12,313
Share placement	28 April 2021		3,037,580	$	1.407		4,274,633
Issued on achievement of a milestone	21 May 2021		2,391,865	$	1.421		3,400,000
Less: share issue transaction costs			—	$	0.000		(1,673,388	)
Balance	30 June 2021		132,012,209				80,290,062

F-25

Notes to the financial statements

June 30, 2021

Note 17. Equity - contributed equity (continued)

Ordinary shares

Ordinary shares entitle the holder to participate in dividends and the proceeds on the winding up of the company in proportion to the number of and amounts paid on the shares held. The fully paid ordinary shares have no par value and the company does not have a limited amount of authorised capital.

On a show of hands every member present at a meeting in person or by proxy shall have one vote and upon a poll each share shall have one vote.

Share buy-back

There is no current on-market share buy-back.

Capital risk management

The consolidated entity’s objectives when managing capital are to safeguard its ability to continue as a going concern, so that it can provide returns for shareholders and benefits for other stakeholders and to maintain an optimum capital structure to reduce the cost of capital.

Capital is regarded as total equity, as recognised in the statement of financial position, plus net debt. Net debt is calculated as total borrowings less cash and cash equivalents.

The capital structure of the consolidated entity consists of cash and cash equivalents and equity attributable to equity holders. The overall strategy of the consolidated entity is to continue its drug development programs, which depends on raising sufficient funds, through a variety of sources including issuing of additional share capital, as may be required from time to time.

The capital risk management policy remains unchanged from the prior year.

Note 18. Equity - Other contributed equity

	2021		2020
	$		$
Convertible note - Triaxial		464,000		464,000

On 4 December 2014, the consolidated entity and the convertible note holder (‘Triaxial’) signed a Convertible Note Deed Poll (‘Deed’) which superseded the precedent Loan Agreement between Triaxial shareholders and the consolidated entity. The Deed extinguishes the liability created by the Loan Agreement and provides that the Convertible Notes will convert into a pre-determined number of ordinary shares on the achievement of defined milestones established in the schedule of the Deed. Accordingly the convertible note has been reclassified as an equity instrument rather than debt instrument.

During the Financial year ended 30 June 2017, the Company reached two milestones triggering the conversion of a portion of its convertible note as follows;

• On 11 August 2016 the Company announced the submission of an IND application. On 10 September 2016, the Company received a letter from the FDA advising the study may proceed triggering conversion of 20,000,000 ordinary shares.

• On 31 October 2016, the Company announced it had licensed a Phase II ready molecule triggering the conversion of 16,000,000 ordinary shares.

During the financial year ended 30 June 2018, a portion of the convertible notes was extinguished.

F-26

Notes to the financial statements

June 30, 2021

Note 18. Equity - Other contributed equity (continued)

The remaining portion of the convertible note will be exercised at the holders’ discretion on completion of Phase II clinical trial or achieving Breakthrough Designation, and would convert to 1,856,000 ordinary shares if converted. Completion will be deemed to occur upon the receipt by the consolidated entity of a signed study report or notification of the designation. There is a possibility for an early conversion of the convertible notes if a third party acquires more than 50% of the issued capital of the consolidated entity.​​​​​​​

Note 19. Equity - reserves

Foreign currency translation reserve

The reserve is used to recognise exchange differences arising from translation of the financial statements of foreign operations to Australian dollars.

Share-based payments reserve

The reserve is used to recognise the value of equity benefits provided to employees and executive directors as part of their remuneration, and other parties as part of their compensation for services.

Note 20. Equity - dividends

Dividends

There were no dividends paid, recommended or declared during the current or previous financial year.

Note 21. Financial instruments

Financial risk management objectives

The consolidated entity’s activities expose it to a variety of financial risks: market risk, credit risk and liquidity risk. The consolidated entity uses different methods to measure and manage the different types of risks to which it is exposed. These methods include monitoring the levels of exposure to interest rates and foreign exchange, ageing analysis and monitoring of specific credit allowances to manage credit risk, and, rolling cash flow forecasts to manage liquidity risk.

Market risk

Foreign currency risk

The consolidated entity operates internationally and is exposed to foreign exchange risk arising from various currency exposures, primarily with respect to the US dollars (‘USD’). Foreign exchange risk arises from future transactions and recognised assets and liabilities denominated in a currency that is not the entity’s functional currency and net investments in foreign operations.

As of 30 June 2021, the consolidated entity did not hold derivative financial instruments in managing its foreign currency, however, the consolidated entity may from time to time enter into hedging arrangements where circumstances are deemed appropriate. The consolidated entity used natural hedging to reduce the foreign currency risk, which involved processing USD payments from cash held in USD. Foreign subsidiaries with a functional currency of Australian Dollars (‘AUD’) have exposure to the local currency of these subsidiaries and any other currency these subsidiaries trade in.

The carrying amount of the consolidated entity’s foreign currency denominated financial assets and financial liabilities at the reporting date was as follows:

	Assets				Liabilities
	2021		2020		2021		2020
	A$’000		A$’000		A$’000		A$’000
US dollars		21,073		272		3,448		2,196
Euros		—		—		16		—
		21,073		272		3,464		2,196

F-27

Notes to the financial statements

June 30, 2021

Note 21. Financial instruments (continued)

The consolidated entity had net assets denominated in foreign currencies of A$17,608,845 as at 30 June 2021 (2020: net liabilities A$1,923,831).

If the AUD had strengthened against the USD by 10% (2020: 10%) then this would have had the following impact:

	AUD strengthened									AUD weakened
Consolidated - 2021	% change			Effect on profit before tax A$’000			Effect on equity A$’000			% change			Effect on profit before tax A$’000			Effect on equity A$’000
US dollars		10	%		(1,762	)		(1,762	)		(10	%)		1,762			1,762
Euros		10	%		1			1			(10	%)		(1	)		(1	)
					(1,761	)		(1,761	)					1,761			1,761
	AUD strengthened									AUD weakened
Consolidated - 2020	% change			Effect on profit before tax A$’000			Effect on equity A$’000			% change			Effect on profit before tax A$’000			Effect on equity A$’000
US dollars		10	%		192			192			(10	%)		(192	)		(192	)

Price risk

The consolidated entity is not exposed to any significant price risk.

Interest rate risk

The consolidated entity’s exposure to market interest rates relate primarily to the investments of cash balances.

The consolidated entity has cash reserves held primarily in Australian dollars and United States dollars and places funds on deposit with financial institutions for periods generally not exceeding three months.

As at the reporting date, the consolidated entity had the following variable interest rate balances:

	2021					2020
	Weighted average interest rate %			Balance A$’000		Weighted average interest rate %			Balance A$’000
Cash at bank and in hand		0.00	%		21,087		0.04	%		1,264
Short term deposits		0.04	%		6,500		0.95	%		7,500
Net exposure to cash flow interest rate risk					27,587					8,764

The consolidated entity has cash and cash equivalents totalling $27,586,760 (2020: $8,764,044). An official increase/decrease in interest rates of 100 basis points (2020: 100 basis points) would have a favourable/adverse effect on profit before tax and equity of $275,867 (2020 $87,640) per annum. The percentage change is based on the expected volatility of interest rates using market data and analysts forecasts.

Credit risk

Credit risk refers to the risk that a counterparty will default on its contractual obligations resulting in financial loss to the consolidated entity. The entity is not exposed to significant credit risk on receivables.

F-28

Notes to the financial statements

June 30, 2021

Note 21. Financial instruments (continued)

The consolidated entity has adopted a lifetime expected loss allowance in estimating expected credit losses to trade receivables through the use of a provisions matrix using fixed rates of credit loss provisioning. These provisions are considered representative across all customers of the consolidated entity based on recent sales experience, historical collection rates and forward-looking information that is available.

The consolidated entity places its cash deposits with high credit quality financial institutions and by policy, limits the amount of credit exposure to any single counter-party. The consolidated entity is averse to principal loss and ensures the safety and preservation of its invested funds by limiting default risk, market risk, and reinvestment risk. The consolidated entity mitigates default risk by constantly positioning its portfolio to respond appropriately to a significant reduction in a credit rating of any financial institution.

Generally, trade receivables are written off when there is no reasonable expectation of recovery. Indicators of this include the failure of a debtor to engage in a repayment plan, no active enforcement activity and a failure to make contractual payments for a period greater than 1 year.

There are no significant concentrations of credit risk within the consolidated entity. The credit risk on liquid funds is limited as the counter parties are banks with high credit ratings.

Credit risk is managed by limiting the amount of credit exposure to any single counter-party for cash deposits.

Liquidity risk

The consolidated entity manages liquidity risk by maintaining adequate cash reserves and by continuously monitoring actual and forecast cash flows and matching the maturity profiles of financial assets and liabilities. In particular, contingent consideration may be satisfied either by payment of cash or by issue of shares, at the discretion of the entity. Remaining contractual maturities

The following tables detail the consolidated entity’s remaining contractual maturity for its financial instrument liabilities. The tables have been drawn up based on the undiscounted cash flows of financial liabilities based on the earliest date on which the financial liabilities are required to be paid. The tables include both interest and principal cash flows disclosed as remaining contractual maturities and therefore these totals may differ from their carrying amount in the statement of financial position.

2021	Weighted average interest rate %		1 year or less A$’000		Between 1 and 2 years A$’000		Between 2 and 5 years A$’000		Over 5 years A$’000		Remaining contractual maturities A$’000
Non-derivatives
Non-interest bearing
Trade payables		—		1,893		—		—		—		1,893
Accrued payables		—		3,039		—		—		—		3,039
Contingent consideration		—		3,165		—		9,306		—		12,471
Total non-derivatives				8,097		—		9,306		—		17,403
2020	Weighted average interest rate %		1 year or less A$’000		Between 1 and 2 years A$’000		Between 2 and 5 years A$’000		Over 5 years A$’000		Remaining contractual maturities A$’000
Non-derivatives
Non-interest bearing
Trade payables		—		1,694		—		—		—		1,694
Accrued payables		—		1,795		—		—		—		1,795
Contingent consideration		—				4,199		—		—		4,199
Total non-derivatives				3,489		4,199		—		—		7,688

The cash flows in the maturity analysis above are not expected to occur significantly earlier than contractually disclosed above.

F-29

Notes to the financial statements

June 30, 2021

Note 22. Fair value measurement

Fair value hierarchy

The following tables detail the consolidated entity’s assets and liabilities, measured or disclosed at fair value, using a three level hierarchy, based on the lowest level of input that is significant to the entire fair value measurement, being:

Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that the entity can access at the measurement date

Level 2: Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly

Level 3: Unobservable inputs for the asset or liability

Consolidated - 2021	Level 1 A$’000		Level 2 A$’000		Level 3 A$’000		Total A$’000
Liabilities
Contingent Consideration		—		—		1,015		1,015
Total liabilities		—		—		1,015		1,015
Consolidated - 2020
Liabilities
Contingent Consideration		—		—		1,845		1,845
Total liabilities		—		—		1,845		1,845

There were no transfers between levels during the financial year.

The fair value of contingent consideration related to the acquisition of Glioblast Pty Ltd and the licence agreement is estimated by probability-weighting the expected future cash outflows, adjusting for risk and discounting.

The effects on the fair value of risk and uncertainty in the future cash flows are dealt with by adjusting the estimated cash flows rather than adjusting the discount rate. The estimated cashflows were adjusted based on the directors’ assessment of achieving contracted milestones as disclosed in Note 15. The probabilities used fell in the range of 35% to 55% and were informed by generally accepted industry probabilities of drugs achieving certain milestones in their progression towards registration.

Level 3 assets and liabilities

Movements in level 3 assets and liabilities during the current and previous financial year are set out below:

	Level 3 A$’000			Available for sale A$’000		Total A$’000
Consolidated
Balance at 1 July 2019		1,370					1,370
Losses recognised in profit or loss		475			—		475
Balance at 30 June 2020		1,845					1,845
Losses recognised in profit or loss		2,570					2,570
Payout of milestone		(3,400	)				(3,400	)
Balance at 30 June 2021		1,015			—		1,015

F-30

Notes to the financial statements

June 30, 2021

Note 23. Key management personnel disclosures

Compensation

The aggregate compensation made to directors and other members of key management personnel (‘KMP’) of the consolidated entity is set out below:

	2021 A$’000		2020 A$’000		2019 A$’000
Short-term employee benefits		1,574		1,324		1,176
Post-employment benefits		112		97		84
Share-based payments		617		230		125
		2,303		1,651		1,385

Please refer to Note 27 for other transactions with key management personnel and their related parties.

Note 24. Remuneration of auditors

During the financial year the following fees were paid or payable for services provided by Grant Thornton Audit Pty Ltd, the auditor of the consolidated entity:

	Consolidated
	2021 A$’000		2020 A$’000		2019 A$’000
Audit services - Grant Thornton Audit Pty Ltd
Audit or review of the financial statements		151		124		120
		151		124		120

Note 25. Contingent liabilities

Other than the contingent consideration set out in note 15, the consolidated entity does not have any other contingent liabilities.

Note 26. Commitments

Lease commitments comprise contracted amounts for leases of premises. The agreement has a duration less than 12 months from financial year end.

Note 27. Related party transactions

Parent entity

Kazia Therapeutics Limited is the parent entity.

Subsidiaries

Interests in subsidiaries are set out in note 29.

Key management personnel

Disclosures relating to key management personnel are set out in note 23 and the remuneration report included in the directors’ report.

Transactions with related parties

There was no other transaction with KMP and their related parties.

F-31

Notes to the financial statements

June 30, 2021

Note 27. Related party transactions (continued)

Receivable from and payable to related parties

There were no trade receivables from or trade payables to related parties at the current and previous reporting date.

Loans to/from related parties

There were no loans to or from related parties at the current and previous reporting date.

Terms and conditions

All transactions were made on normal commercial terms and conditions and at market rates.

Note 28. Parent entity information

Set out below is the supplementary information about the parent entity.

	Parent
	2021 A$’000			2020 A$’000
Statement of profit or loss and other comprehensive income
Loss after income tax		(16,854	)		(11,064	)
Total comprehensive income		(16,854	)		(11,064	)
	2021 A$’000			2020 A$’000
Statement of financial position
Total current assets		25,042			9,703
Total assets		47,044			22,113
Total current liabilities		3,177			1,522
Total liabilities		15,032			5,393
Equity
Contributed equity		80,290			48,781
Other contributed equity		464			464
Reserves		1,754			1,521
Accumulated losses		(50,496	)		(34,046	)
Total equity		32,012			16,720

Reserves comprise Share Based Payments Reserve.

Contingent liabilities

The parent entity contingent liabilities as at 30 June 2021 and 30 June 2020 are as set out in Note 15. The contingent consideration is specific to the parent entity.

Capital commitments - Property, plant and equipment

The parent entity had no capital commitments for property, plant and equipment at as 30 June 2021 and 30 June 2020.

Significant accounting policies

The accounting policies of the parent entity are consistent with those of the consolidated entity, as disclosed in note 2, except for the following:

• Investments in subsidiaries are accounted for at cost, less any impairment, in the parent entity.

• Dividends received from subsidiaries are recognised as other income by the parent entity and its receipt may be an indicator of an impairment of the investment.

F-32

Notes to the financial statements

June 30, 2021

Note 29. Interests in subsidiaries

The consolidated financial statements incorporate the assets, liabilities and results of the following subsidiaries in accordance with the accounting policy described in note 2:

		Ownership interest
Name	Principal place of business / Country of incorporation	2021 %			2020 %
Kazia Laboratories Pty Ltd	Australia		100.00	%		100.00	%
Kazia Research Pty Ltd	Australia		100.00	%		100.00	%
Kazia Therapeutics Inc.	United States of America		100.00	%		100.00	%
Glioblast Pty Ltd	Australia		100.00	%		100.00	%
Kazia Therapeutics (Hong Kong) Limited	Hong Kong		100.00	%		—

Note 30. Reconciliation of loss after income tax to net cash used in operating activities

	2021			2020			2019
	A$’000			A$’000			A$’000
Loss after income tax expense from continuing operations		(8,422	)		(12,467	)		(10,270	)
Adjustments for:
Depreciation & amortisation		1,265			1,084			1,084
Impairment of property, plant & equipment		—			—			1
Net fair value loss on financial assets		—			168			1,809
Share based payments		637			262			246
Foreign exchange differences		430			—			—
Loss on contingent consideration		2,570			474			63
Change in operating assets & liabilities:		(3,521	)		(10,479	)		(7,067	)
Decrease in trade and other receivables		(5,027	)		358			825
Increase in accrued revenue		—			—			(138	)
Decrease/(increase) in prepayments		(1,182	)		(168	)		398
Decrease/(increase) in trade and other payables		1,010			1,722			(409	)
Decrease in deferred tax liability		(484	)		(298	)		(298	)
Increase/(decrease) in other provisions		93			55			(25	)
Net cash used in operating activities		(9,111	)		(8,810	)		(6,714	)

Significant non-cash transactions

During the year the consolidated entity acquired a licensing agreement in relation to the asset EVT801. At year end no portion of the purchase price had been paid and accordingly the transaction does not appear in the cash flow statement.

Furthermore, the consolidated entity issued shares in satisfaction of an acquisition milestone. This transaction did not involve cash and accordingly the transaction does not appear in the cash flow statement.

F-33

Notes to the financial statements

June 30, 2021

Note 31. Earnings per share

	2021 A$’000			2020 A$’000			2019 A$’000
Loss after income tax attributable to the owners of Kazia Therapeutics Limited		(8,422	)		(12,467	)		(10,270	)
Loss after income tax attributable to the owners of Kazia Therapeutics Limited		(8,422	)		(12,467	)		(10,270	)
	Number			Number			Number
Weighted average number of ordinary shares used in calculating basic earnings per share		117,674,543			73,053,514			57,503,555
Weighted average number of ordinary shares used in calculating Diluted earnings per share		117,674,543			73,053,514			57,503,555
	Cents			Cents			Cents
Basic earnings per share		(7.16	)		(17.07	)		(17.86	)
Diluted earnings per share		(7.16	)		(17.07	)		(17.86	)

1,865,000 unlisted convertible notes with a face value of A$464,000 and 4,446,500 unlisted options have been excluded from the above calculations as they were antidilutive.

Note 32. Share-based payments

All of the options set out below have been issued to employees and directors under the ESOP. During the financial year an expense of $636,383 was recognised.

2021

Tranche	Grant date		Expiry date		A$ Exercise price		Balance at the start of the year		Granted		Exercised			Expired/ lapsed on termination of employment			Balance at the end of the year
1		16/11/2015		16/11/2020	$	2.200		236,667		—		—			(236,667	)		—
2		05/09/2016		05/09/2021	$	1.630		50,000		—		—			—			50,000
3		12/10/2016		17/10/2021	$	1.560		62,000		—		—			—			62,000
4		31/10/2016		01/11/2021	$	1.380		12,500		—		—			—			12,500
5		21/11/2016		23/11/2021	$	1.380		50,000		—		—			—			50,000
6		07/08/2017		07/08/2022	$	0.670		224,000		—		(121,500	)		(15,500	)		87,000
7		05/02/2018		05/02/2023	$	0.780		440,000		—		(120,000	)		—			320,000
8		04/01/2019		04/01/2024	$	0.492		250,000		—		(200,000	)		(12,500	)		37,500
9		13/11/2019		04/01/2024	$	0.492		1,200,000		—		—			—			1,200,000
10		13/01/2020		13/01/2025	$	0.881		250,000		—		—			(50,000	)		200,000
11		09/11/2020		13/01/2025	$	1.132		—		1,200,000		—			—			1,200,000
12		09/11/2020		13/01/2025	$	0.881		—		800,000		—			—			800,000
13		04/01/2021		04/01/2025	$	1.690		—		200,000		—			—			200,000
								2,775,167		2,200,000		(441,500	)		(314,667	)		4,219,000
Weighted average exercise price							$	0.797	$	1.090	$	0.620		$	1.850		$	$0.826

No options were forfeited during the year.

F-34

Notes to the financial statements

June 30, 2021

Note 32. Share-based payments (continued)

At the end of the period the following outstanding options were vested and exercisable:

- Options in tranche 1 have expired during the year

- Options in tranches 2- 8 were vested and exercisable except for tranche 6 which was vested as to 53%

- Options in tranche 9 were vested as to 1million of the 1.2million options on issue

- Options in tranches 10-12 were 25% vested

- Options in tranche 13 were unvested at year end

The weighted average remaining contractual life of options outstanding at the 30 June 2021 is 2.6 years.

2020

Tranche	Grant date		Expiry date		A$ Exercise price		Balance at the start of the year		Granted		Modified			Expired			Balance at the end of the year
1		04/03/2015		16/12/2019	$	1.500		46,647		—		—			(46,647	)		—
2		04/03/2015		18/12/2019	$	1.500		19,952		—		—			(19,952	)		—
3		24/06/2015		30/06/2020	$	4.000		519,000		—		—			(519,000	)		—
4		16/11/2015		16/11/2020	$	2.200		236,667		—		—			—			236,667
5		18/03/2016		01/02/2021	$	1.990		300,000		—		(300,000	)		—			—
6		18/03/2016		01/02/2021	$	1.990		200,000		—		(200,000	)		—			—
7		18/03/2016		01/02/2021	$	2.610		250,000		—		(250,000	)		—			—
8		05/09/2016		05/09/2021	$	1.630		50,000		—		—			—			50,000
9		12/10/2016		17/10/2021	$	1.560		62,000		—		—			—			62,000
10		31/10/2016		01/11/2021	$	1.380		12,500		—		—			—			12,500
11		21/11/2016		23/11/2021	$	1.380		50,000		—		—			—			50,000
12		07/08/2017		07/08/2022	$	0.670		224,000		—		—			—			224,000
13		05/02/2018		05/02/2023	$	0.780		440,000		—		—			—			440,000
14		04/01/2019		04/01/2024	$	0.492		250,000		—		—			—			250,000
15		13/11/2019		04/01/2024	$	0.492		—		—		1,200,000			—			1,200,000
16		13/01/2020		13/01/2025	$	0.881		—		250,000		—			—			250,000
								2,660,766		250,000		450,000			(585,599	)		2,775,167
Weighted average exercise price							$	1.960	$	0.880	$	2.348		$	3.716		$	0.797

At the end of the period the following outstanding options were vested and exercisable:

- Options in tranches 4, 8, 10, 11 and 13 were vested and exercisable

- Options in tranche 16 were unvested

- Options in the other tranches were vested as follows: 9: 75%, 12: 50% 14: 50% and 15: 67%.

All remaining options are expected to vest in future periods.

The weighted average remaining contractual life of options outstanding at the 30 June 2020 is 2.78 years.

Employee share options

During the year ended 30 June 2021, 2,200,000 options have been issued to the employees by the consolidated entity pursuant to the Company’s Employee Share Option Plan.

• Tranche 11 vests in four equal 6-monthly tranches from 1 January 2021

• Tranche 12 vests in four equal annual amounts from 13 January 2021

• Tranche 13 vests in four equal annual tranches from 4 January 2022

F-35

Notes to the financial statements

June 30, 2021

Note 32. Share-based payments (continued)

Options within all tranches will only vest if the option holder continues to be a full-time employee with the Company or an Associated Company during the vesting period relating to the option.

Conditions for an option to be exercised:

• The option must have vested.

• Option holder must have provided the Company with an Exercise Notice and have paid the Exercise Price for the option.

• The Exercise Notice must be for the exercise of at least the Minimum Number of Options;

• The Exercise Notice must have been provided to the Company and Exercise Price paid before the expiry of 5 years from the date the Option is issued.

Options Valuation

In order to obtain a fair valuation of these options, the following assumptions have been made:

The Black Scholes option valuation methodology has been used with the expectation that the majority of these options would be exercised towards the end of the option term. Inputs into the Black Scholes model includes the share price at grant date, exercise price, volatility, and the risk free rate of a five year Australian Government Bond on grant date.

Risk-free rate and grant date

For all tranches, the risk-free rate of a five-year Australian Government bond on grant date was used. Please refer to the table below for details.

Options in Tranches 1 to 13 have various vesting periods and exercising conditions. These options are unlisted as at 30 June 2021.

No dividends are expected to be declared or paid by the consolidated entity during the terms of the options.

The underlying expected volatility was determined by reference to historical data of the Company’s shares over a period of time.

No special features inherent to the options granted were incorporated into measurement of fair value.

Based on the above assumptions, the table below sets out the valuation for each tranche of options:

Grant date	Expiry date	Share price at Grant Date	Exercise price	Volatility (%)	Remaining Life (years)	Risk free Rate (%)	Fair value per option
05/09/2016	05/09/2021	$0.105	$1.630	122.00%	1.16	1.60%	$0.840
12/10/2016	17/10/2021	$0.098	$1.560	122.00%	1.29	1.89%	$0.780
31/10/2016	01/11/2021	$0.090	$1.380	122.00%	1.20	1.87%	$0.720
21/11/2016	23/11/2021	$0.092	$1.380	122.00%	1.20	2.10%	$0.730
07/08/2017	07/08/2022	$0.430	$0.670	74.50%	2.08	1.95%	$0.206
05/02/2018	05/02/2023	$0.500	$0.780	74.50%	2.58	1.95%	$0.200
04/01/2019	04/01/2024	$0.340	$0.493	74.50%	3.50	1.95%	$0.140
13/11/2019	04/01/2024	$0.410	$0.493	74.50%	4.20	1.95%	$0.180
13/01/2020	13/01/2025	$0.620	$0.881	74.50%	4.50	1.95%	$0.340
09/11/2020	09/11/2024	$0.890	$1.132	90.00%	2.10	0.10%	$0.379
09/11/2020	09/11/2024	$0.890	$1.132	90.00%	2.30	0.10%	$0.403
09/11/2020	09/11/2024	$0.890	$1.132	90.00%	2.60	0.10%	$0.425
09/11/2020	09/11/2024	$0.890	$1.132	90.00%	2.80	0.10%	$0.446
09/11/2020	13/01/2025	$0.890	$0.881	90.00%	2.20	0.10%	$0.450
09/11/2020	13/01/2025	$0.890	$0.881	90.00%	2.70	0.10%	$0.490
09/11/2020	13/01/2025	$0.890	$0.881	90.00%	3.20	0.10%	$0.520
09/11/2020	13/01/2025	$0.890	$0.881	90.00%	3.70	0.10%	$0.550
04/01/2021	04/01/2025	$1.185	$1.169	90.00%	2.50	0.19%	$0.520
04/01/2021	04/01/2025	$1.185	$1.169	90.00%	3.00	0.19%	$0.576
04/01/2021	04/01/2025	$1.185	$1.169	90.00%	3.50	0.19%	$0.627
04/01/2021	04/01/2025	$1.185	$1.169	90.00%	4.00	0.19%	$0.671

Note 33. Subsequent events

There were no significant events subsequent to the reporting date.

F-36

EX-4.18

Exhibit 4.18

CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT WAS OMITTED BY MEANS

OF MARKING SUCH INFORMATION WITH BRACKETS (“[***]”) BECAUSE THE

IDENTIFIED CONFIDENTIAL INFORMATION IS NOT MATERIAL AND IS THE TYPE

THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

Kazia Therapeutics Limited

Oasmia Pharmaceutical AB

Development and Commercialisation Licence Agreement

A licencing Agreement to develop and commercialise Cantrixil

Development and Commercialisation Licence Agreement

Contents
1	Definitions and Interpretation		4
	1.1	Definitions	4
	1.2	Interpretation	9
2	Commercialisation of Licensed Product		9
3	Grant of Licence		9
	3.1	Kazia Patents and Associated Intellectual Property Licence grant	9
	3.2	Sub-licencing and sub-contracting	10
	3.3	Rights of Oasmia	10
	3.4	Improvements	10
4	Transfer of Know-How and assistance from Kazia		11
	4.1	Transfer of Kazia Know-How and the Cantrixil Dossier	11
	4.2	Assistance in respect of Manufacturing and supply of Licensed Product	11
5	Commercialisation		11
	5.1	Sales and distribution in the Territory	11
	5.2	Royalty Reports	12
6	Payment		13
	6.1	Upfront fee	13
	6.2	Royalty	13
	6.3	Milestone Payments	13
	6.4	Payment requirements	13
	6.5	Default in payment	13
	6.6	No deductions	13
7	Alliance Manager		14
8	Obligations		14
	8.1	Mutual obligations	14
	8.2	Oasmia’s responsibilities	14
	8.3	Kazia’s responsibilities	14
9	Governmental Matters		15
	9.1	Regulatory approvals	15
10	Prosecution, Proceedings and Protection of Rights		15
	10.1	Prosecution and maintenance of Kazia Patents	15
	10.2	Notification of Claims	16
	10.3	[***]	16
	10.4	[***]	16
	10.5	[***]	16
	10.6	[***]	16
	10.7	[***]	17
	10.8	[***]	17
11	Warranties and Indemnities		17
	11.1	Representations and warranties by the parties	17
	11.2	Representations and warranties by Kazia	17
	11.3	Representations and warranties by Oasmia	18
	11.4	Warranties separate	18
	11.5	No other representations or warranties	18
	11.6	Period of warranties and indemnity	18
	11.7	Reliance	18

page (i)

Development and Commercialisation Licence Agreement

12	Indemnities and Liability		19
	12.1	[***]	19
	12.2	[***]	19
	12.3	Exclusions	19
13	Insurance		19
	13.1	The parties obligation to insure	19
	13.2	Requirements for insurance policies	20
	13.3	Evidence of currency	20
14	Records and Audit		20
	14.1	Records	20
	14.2	Audit	21
15	Reporting		21
16	Term and Termination		22
	16.1	Term	22
	16.2	Termination by either party	22
	16.3	Termination by Oasmia	22
	16.4	Termination by Kazia	22
	16.5	General consequences of termination and survival	23
	16.6	Specific consequences of termination	23
17	Assignment		23
	17.1	Assignment by Oasmia	23
	17.2	Assignment by Kazia	23
18	Confidentiality		24
	18.1	Obligations of confidentiality	24
	18.2	Permitted Disclosure	24
	18.3	Exceptions	25
	18.4	Kazia Know-How	25
	18.5	Return or destruction of Confidential Information	25
	18.6	Liability for breach by recipient	25
	18.7	Survival of Obligation	25
	18.8	Public announcements	25
19	Costs and Duty		25
20	Notice		26
21	Dispute Resolution		27
	21.1	Parties to attempt resolution	27
	21.2	Meeting between Alliance Managers	27
	21.3	Negotiations	27
	21.4	Arbitration	27
	21.5	Continuation of rights and obligations	28
22	Force Majeure		28
	22.1	Event of Force Majeure	28
	22.2	Force Majeure notice	28
	22.3	Remedy of Force Majeure	28
	22.4	Mitigation	28
	22.5	No requirement to settle labour dispute	28
	22.6	No extension of Term	28

page (ii)

Development and Commercialisation Licence Agreement

23	General	28
Schedule 1		30
	Upfront fee, Milestone Payments and Royalty	30
Schedule 2		32
	Part 1	32
	Kazia Patents	32
Schedule 3		35
	Cantrixil Manufacturers	35
Schedule 4		34
	Assistance to be provided by Kazia	34
Schedule 5		36

page (iii)

Development and Commercialisation Licence Agreement

This Agreement is made on

Parties

1 Kazia Therapeutics Limited (ACN 063 259 754) of Three International Towers, Level 24 300 Barangaroo Avenue, Sydney NSW 2000 (Kazia).

2 Oasmia Pharmaceutical AB incorporated in Sweden of Vallongatan 1, 752 28 Uppsala, Sweden (Oasmia).

Recitals

A Kazia is the registered owner of the Kazia Patents and is the owner of the Associated Intellectual Property in relation to the Licensed Product.

B. Kazia has agreed to grant Oasmia, and Oasmia accepts, a global exclusive licence to the Licensed Product and the Associated Intellectual Property, on the terms and subject to the conditions of this Agreement.

C. The parties have entered into this Agreement with the goal of transferring Kazia’s world-wide rights to Develop and Commercialise the Licensed Product to Oasmia and for Oasmia to use its Commercially Reasonable Efforts to maximise the earnings from the Licensed Product during the Term.

D. The parties agree to undertake their respective obligations under this Agreement in good faith in order to try and achieve the above stated goal.

It is agreed as follows.

1 Definitions and Interpretation

1.1 Definitions

The following definitions apply unless the context requires otherwise.

Affiliate means, with respect to a party, any entity that controls or is controlled by such party, or is under common control with such party. For the purposes of this definition, an entity shall be deemed to control another entity if it owns or controls, directly or indirectly, at least fifty percent (50%) of the voting equity of another entity (or other comparable interest for an entity other than a corporation).

Agreement means this Agreement including any schedules and annexures, and any subsequent amendments to this Agreement made in accordance with its terms.

Applicable Law means the laws which apply to the acts and omissions of either party in the course of carrying out this Agreement.

Associated Intellectual Property means any intellectual property specifically and demonstrably referable to the Development of the Licensed Products that is owned or otherwise held by Kazia or one of its Affiliates including any copyright, trade mark, Kazia Know-How, confidential information or invention, that is reasonably required by Oasmia for the Development or Commercialisation of the Licensed Product, or is reasonably necessary to Oasmia to otherwise exercise its rights or carry out its obligations under this Agreement.

Business Day means a day which is not a Saturday, Sunday or a public holiday in Sweden or Sydney, Australia.

page 4

Development and Commercialisation Licence Agreement

Cantrixil Dossier means:

(a) the original IND relating to the Licensed Product opened with the FDA in 2016 (Original IND);

(b) all subsequent submissions made to the FDA with respect to the Original IND;

(c) all documents in the possession of Kazia and its Affiliates not yet submitted to the FDA but which would reasonably be expected to be submitted under the IND in the normal course of drug development;

(d) any material correspondence relating to the Licensed Product between Kazia and its Affiliates with the FDA or other regulatory agencies which would not be expected to form part of the IND, including any orphan drug applications;

(e) all batch records, stability data, analytical results, and other customary documentation in the possession of Kazia and its Affiliates pertaining to prior manufactured batches of Licensed Product;

(f) all known publications of Cantrixil data relating to Licensed Product, published and in draft;

(g) any non-clinical data in the possession of Kazia or its Affiliates, such as through research collaborations, which may reasonably be considered necessary to Oasmia in the further development of Licensed Product; and

(h) any clinical study protocols, study reports and safety information (pre-clinical and clinical) in the possession of Kazia or its Affiliates relating to Licensed Product, including clinical trial database, safety database, trial master file, audit reports and phase I trial dashboard (eg. list of trial sites, trial screening and enrolment rate per site).

With respect to each of the above other than drafts contemplated expressly in paragraph (f), documents will be supplied in their final and definitive form. Documents which have not yet been finalised will be supplied in the form of the latest draft in Kazia’s possession.

Cantrixil Manufacturers means the manufacturers listed in Schedule 3.

Claim means, in relation to a party, a demand, claim, action or proceeding threatened, made or brought by or against the party, however arising and whether present. unascertained, immediate, future or contingent.

Commercialisation means any and all activities directed to marketing, promoting, detailing, distributing, supplying, importing, exporting, offering for sale, having sold and/or selling and other activities for the commercialisation of the Licensed Product in the Territory, including: market research and educational activities; and activities necessary to obtain and maintain Marketing Approval, Pricing Approval, reimbursement and/or listing on health care providers’ and payers’ formularies in the Territory. For the avoidance of doubt, use of the terms Commercialise, Commercialising and/or Commercialisation in this Agreement shall not be deemed to include sales where there is not a Marketing Approval.

Commercially Reasonable Efforts means those efforts that would be made by a pharmaceutical company (of comparable size and resources to the relevant party) acting in good faith and in the exercise of activities or in relation to products of a similar potential value, stage of research or development, life cycle and commercial potential of the Licensed Product, taking into account all relevant factors that such party would normally take into account, including issues of safety and efficacy, product profile, the competitiveness of alternative products (including generic products), the patent or other proprietary position of such product (including patent coverage and regulatory exclusivity), the regulatory requirements involved and the potential profitability of such product.

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Development and Commercialisation Licence Agreement

Confidential Information means the terms of this Agreement and all information belonging or relating to a party to this Agreement, whether oral, graphic, electronic, written or in any other form, that is:

(a) or should reasonably be regarded as, confidential to the party to whom it belongs or relates;

(b) not generally available to the public other than by reason of a breach of this Agreement; or

(c) is disclosed to the Receiving Party by a third party lawfully in possession of such information and who is under no obligation to maintain such information in confidence.

Development means activities directly and specifically relating to research, pre-clinical, nonclinical, or clinical drug development, including test method development and stability testing, assay development, toxicology, pharmacology, formulation, quality assurance/quality control development, technology transfer, statistical analysis, process development and scale-up, pharmacokinetic studies, data collection and management, clinical studies (including research to design clinical studies), regulatory affairs, drug safety surveillance activities related to clinical studies, investigator sponsored studies, and the preparation, submission and maintenance of registration filings and approvals and any non-approval activity.

Disclosing Party means the party to whom information belongs or relates.

Effective Date means 1 March 2021.

FDA means the U.S. Food & Drug Administration.

Force Majeure means an event or cause beyond the reasonable control of the party claiming force majeure. It includes each of the following, to the extent it is beyond the reasonable control of that party:

(a) act of God, lightning, storm, flood, fire, earthquake or explosion;

(b) strike, lockout or other labour difficulty;

(c) act of public enemy, war (declared or undeclared), terrorism, sabotage, blockade, revolution, riot, insurrection, civil commotion, epidemic, pandemic or public health emergency (excluding the COVID-19 pandemic as in existence at the Effective Date), or any resulting governmental action including work stoppages, mandatory business, service or workplace closures, full or partial lockdown of affected areas, quarantines, border closures and travel restrictions;

(d) embargo, inability to obtain any necessary materials, equipment, facilities or qualified employees, power or water shortage, lack of transportation; and

(e) breakage or accident or other damage to machinery other than as a result of lack of appropriate maintenance, care, process or security.

Good Distribution Practice means the principles and rules in line with good distribution practice guidelines in the country of the Marketing Approval which ensure that medicinal products are consistently stored, transported and handled under suitable conditions as required by the Marketing Approval of the Licensed Product.

IND means an investigational new drug application made to the FDA.

Improvement means any improvements, enhancements, modifications, adaptations, extensions, developments, mutations, applications of and all other technical advances made by or on behalf of a person, whether or not protected by statute.

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Development and Commercialisation Licence Agreement

Insolvency Event means the occurrence of any of the following events in respect of either party:

(a) any step is taken (including any resolution passed at a meeting, or an application made or proceedings commenced, where that application or those proceedings are not withdrawn or set aside within 14 days of being made or commenced) for:

(i) the winding up, dissolution, or administration of either party; or

(ii) either party entering into any arrangement, compromise or composition with or assignment for the benefit of its creditors or any class of them,

except for the purposes of a solvent reconstruction or amalgamation; or

(b) a receiver, receiver and manager, or other controller, administrator or similar officer is appointed with respect to or takes control of either party or any of its assets or undertakings.

Interest Rate means a rate of ten percent (10%) per month, or if lower, the maximum amount permitted under Applicable Law.

Kazia Know-How means Know-How owned or controlled by Kazia or any of Kazia’s Affiliates at the Effective Date or at any time thereafter during the Term which relates to the Licensed Product and is reasonably required by Oasmia for the Development, Manufacturing and Commercialisation of the Licensed Product or as is reasonably necessary to otherwise exercise its rights or carry out its obligations under this Agreement.

Kazia Patents means:

(a) the patent registrations and pending patent registrations listed in Part 1 of Schedule 2; and

(b) all patents and all substitutions, divisions, continuations, continuations-in-part, reissues, renewals, validations, reexaminations and extensions thereof and supplemental protection certificates relating thereto, and all counterparts thereof in any country in the world,

but solely to the extent they relate to:

(c) a composition of matter comprising the chemical structure set out in Part 2 of Schedule 2;

(d) a method of use involving said chemical structure; or

(e) a method of Manufacture of the Licensed Product comprising said chemical structure..

Know-How means any and all information, data and materials whether proprietary or not, and whether patentable or not, including without limitation, technical or scientific information, know-how, data, test results, knowledge, technology, methods, processes, techniques, discoveries, inventions, specifications, designs, trade secrets, regulatory filings and other information (whether or not patentable or otherwise protected by trade secret law) in written, electronic or other form.

Liabilities means any debts, obligations, liabilities, losses, expenses, costs and damages of any kind and however arising, including penalties, fines, and interest and including those which are prospective or contingent and those the amount of which, for the time being, is not ascertained or ascertainable.

Licence has the meaning given to that term in clause 3.1.

Licensed Product means any product containing the chemical structure set out in Part 2 of Schedule 2 for the indication of ovarian cancer and any other future indications, when used as a monotherapy or in combination with other drugs and other therapeutic approaches.

Manufacturing means activities directed to the manufacture of the Licensed Product including, the planning, purchasing, producing, manufacturing, processing, transportation, quality assurance testing, quality control, regulatory compliance, storage and maintenance of cell banks, manufacture and testing of future cell banks, waste disposal, sample retention, formulation, stability testing, storage, filling, packaging, labelling, leafleting, release and dispatch and such other related matters in each case as applicable to the Licensed Product.

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Development and Commercialisation Licence Agreement

Marketing Approval means any approval of the applicable regulatory authorities necessary for the Commercialisation, marketing, labelling, and sale of the Licensed Product, but excluding any separate Pricing Approval.

Milestone Payment means the payments set out in Schedule 1 Part C.

Named Patient Basis means the supply of the Licensed Product directly to an individual patient upon unsolicited requests from medical professionals, in a territory where the Licensed Product has not obtained Marketing Approval.

Net Sales means the gross invoiced price for all Licensed Products sold by Oasmia, its Affiliates or sub-licensees to third parties in the Territory, less the following deductions from such gross amounts:

(a) normal and customary trade, cash and other quantity discounts, rebates and allowances actually allowed and taken;

(b) credits or allowances actually granted to the customer for damaged goods, returns, recalls, rebates or rejections of Licensed Products;

(c) sales taxes, excise taxes, value added taxes and custom duties actually paid to a governmental authority, included in the invoiced price and not reimbursed directly or indirectly;

(d) reasonable chargebacks related to sales of Licensed Products, to the extent actually allowed and taken by a third party;

(e) reasonable freight, insurance and other transportation and handling fees to the extent that such charges were included on the invoice provided to the customer; and

(f) compulsory payments and rebates directly related to the sale of Licensed Products, accrued, paid or deducted pursuant to governmental regulations.

Pricing Approval means such approval, agreement, determination or governmental decision establishing pricing and reimbursement for the Licensed Product that can be charged to customers and will be reimbursed by governmental authorities or payers in any jurisdiction in the Territory.

Receiving Party means the party to whom information is disclosed or who possesses or otherwise acquires information belonging or relating to a Disclosing Party.

Resolution Institute means the Australian and New Zealand dispute resolution membership organisation known as the Resolution Institute.

Royalty is the royalty to be paid by Oasmia to Kazia on Net Sales in the Territory during the Term of this Agreement for the value given in Part B of Schedule 1.

Term has the meaning given in clause 16.1.

Territory means the world.

Transfer means providing information in a fully and properly documented form, and for soft copies, capable of being received, opened, downloaded and saved through the use of commonly available and used commercial software.

[***]

[***]

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Development and Commercialisation Licence Agreement

1.2 Interpretation

(a) Headings are for convenience only and do not affect interpretation.

(b) Mentioning anything after includes, including, for example, or similar expressions, does not limit what else might be included.

(c) Nothing in this Agreement is to be interpreted against a party solely on the ground that the party put forward this Agreement or a relevant part of it.

(d) The following rules apply unless the context requires otherwise.

(i) The singular includes the plural, and the converse also applies.

(ii) If a word or phrase is defined, its other grammatical forms have a corresponding meaning.

(iii) A reference to a person includes a corporation, trust, partnership, unincorporated body or other entity, whether or not it comprises a separate legal entity.

(iv) A reference to anything (including a right, obligation or concept) includes each part of it.

(v) A reference to a clause is a reference to a clause of this Agreement.

(vi) A reference to writing includes any method of representing or reproducing words, figures, drawings or symbols in a visible and tangible form.

(vii) A reference to a party to this Agreement or another agreement or document includes the party’s successors, permitted substitutes and permitted assigns (and, where applicable, the party’s legal personal representatives).

(viii) A reference to legislation or to a provision of legislation includes a modification or re-enactment of it, a legislative provision substituted for it and a regulation or statutory instrument issued under it.

(ix) A reference to time is to time in Sydney, Australia.

2 Commercialisation of Licensed Product

(a) The parties acknowledge that:

(i) as at the Effective Date, the Licensed Product has successfully completed phase I clinical trials; and

(ii) Oasmia will use its Commercially Reasonable Efforts to progress the Licensed Product through phase II and Ill clinical trials, and to Commercialise the Licensed Product, within a reasonable time.

(b) The parties acknowledge that, while as at the Effective Date, the Licensed Product has successfully completed phase I clinical trials and it is the parties’ hope that the results of such trials may be used to assist in obtaining Marketing Approvals in the Territory, no assurances, representations or warranties are given in this regard.

3 Grant of Licence

3.1 Kazia Patents and Associated Intellectual Property Licence grant

Subject to the terms and conditions of this Agreement, on and from the Effective Date Kazia grants to Oasmia and Oasmia accepts an exclusive licence under the Kazia Patents and Associated Intellectual Property to:

(a) Manufacture, supply and export the Licensed Product, or permit others to do so;

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Development and Commercialisation Licence Agreement

(b) Develop the Licensed Product;

(c) make sales of or otherwise supply the Licensed Product on a Named Patient Basis to the extent permitted by Applicable Law; and

(d) Commercialise the Licensed Product,

for the duration of the Term (the Licence).

3.2 Sub-licencing and sub-contracting

(a) Oasmia may, without any requirement to consult with or seek approval from Kazia, sub-license the Licence or subcontract any rights granted under this Agreement to any of its Affiliates or any other third parties. In such circumstances, Oasmia must:

(i) ensure that any sub-licensee or subcontractor agrees in writing to be subject to, and bound by, to the extent applicable, terms and conditions substantially similar to the terms and conditions of this Agreement; and

(ii) notify Kazia of the identity of the sub-licensee or subcontractor within 7 days of their engagement.

(b) Oasmia will be responsible to Kazia for any Liability suffered by Kazia resulting from any act or omission of a sub-licensee relating to a sub- licence or subcontractor relating to a subcontract (a Wrong), but only to the extent that Oasmia would be liable to Kazia under this Agreement had Oasmia committed the Wrong.

(c) Oasmia must enforce any sub-licensees’ or subcontractors’ obligations under any respective sublicense or subcontract agreements granted to sub-licensees or subcontractors in accordance with this clause 3.2. Oasmia remains responsible for the performance of the obligations of its sub-licensees and subcontractors, as if such obligations were carried out by Oasmia itself, including the payment of Royalties or Milestone Payments as provided for under this Agreement.

3.3 Rights of Oasmia

Without limiting the Licence granted under clause 3.1, Kazia grants to Oasmia and its successors and assignees a royalty-free, irrevocable for the Term, exclusive and sub-licensable licence to the Cantrixil Dossier, to the extent necessary for, and solely for the purpose of, the performance of this Agreement.

3.4 Improvements

(a) Oasmia must notify Kazia of any Improvements which it or its personnel, sub-licensees or subcontractors discovers or develops with respect to any of the Kazia Patents and Associated Intellectual Property within 30 days from the discovery or development.

(b) The parties agree that all rights, title and interest in Improvements to the Kazia Patents and Associated Intellectual Property developed or discovered by or on behalf of Oasmia vest in (as between the parties) Oasmia.

(c) Upon termination or expiry of this Agreement, Oasmia agrees to grant Kazia a non-exclusive, royalty-free, sub-licensable and perpetual licence to any Improvements to the Kazia Patents and Associated Intellectual Property in the Territory.

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4 Transfer of Kazia Know-How and assistance from Kazia

4.1 Transfer of Kazia Know-How and the Cantrixil Dossier

(a) As soon as reasonably practicable after the Effective Date Kazia must Transfer to Oasmia in its entirety, the Kazia Know-How and Cantrixil Dossier.

(b) Where Oasmia considers that any information provided to Oasmia in accordance with clause 4.1(a) is missing, incomplete or unclear, Oasmia has the right to reasonably request through a question-and-answer process additional information in relation to that information. Kazia must act reasonably in considering any such request.

(c) Without limiting clause 4.1(a), with regards to Kazia Know-How related to the Manufacturing of the Licensed Product, Kazia acknowledges that the Transfer to Oasmia may take some time to complete and that Kazia will provide reasonable assistance in connection with the Transfer when reasonably requested until the earlier of the completion of the Transfer or 18 months after the Effective Date. Kazia must use Commercially Reasonable Efforts to maintain adequate available resources to effect the Transfer and provide reasonable assistance to Oasmia.

4.2 Assistance in respect of Manufacturing and supply of Licensed Product

Upon the reasonable request of Oasmia, Kazia agrees to use Commercially Reasonable Efforts to assist Oasmia:

(a) by facilitating proper introductions to the Cantrixil Manufacturers to seek to facilitate those manufacturers to enter into manufacturing agreements with Oasmia; and

(b) in any of the circumstances set out in Schedule 4.

For the purpose of this clause 4.2, Kazia acknowledges that its Commercially Reasonable Efforts must include, where available, the allocation of Kazia resources and personnel that possess the appropriate experience, skills and qualifications required to provide the requested assistance to Oasmia. For the avoidance of doubt, the parties acknowledge that, in providing its best efforts:

(c) while Kazia will seek to allocate sufficient resources to accommodate requested assistance in a timely manner, such allocation will be dependent on Kazia’s activities and resource capacity at the time of any request; and

(d) Kazia will not be obliged to obtain resources or engage personnel in addition to those personnel engaged by it at the time a request for assistance is made by Oasmia.

5 Commercialisation

5.1 Sales and distribution in the Territory

Oasmia shall invoice and book, and appropriately record, all sales of the Licensed Product in the Territory including for the avoidance of doubt, any sale of Licensed Product in the Territory made by sub-licensees or subcontractors. Oasmia shall also be responsible for:

(a) the distribution of Licensed Product in the Territory and for paying all governmental discounts and/or rebates which are due and owing with respect to the Licensed Product in the Territory using Good Distribution Practices,

(b) handling all returns of Licensed Product sold under this Agreement, and

(c) handling all aspects of ordering, processing, invoicing, collection, distribution and receivables with respect to Licensed Product in the Territory.

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5.2 Royalty Reports

(a) Starting from the first commercial sale or sale made on a Named Patient Basis, within 30 calendar days after the end of each calendar quarter, Oasmia shall deliver to Kazia a written report setting forth, on a country-by-country basis in the Territory for such calendar quarter:

(i) the number of units of each Licensed Product sold on a country by country basis;

(ii) the gross sales of each Licensed Product for each country in which the Licensed Product is being sold via commercial sale or on a Named Patient Basis;

(iii) the Net Sales of each Licensed Product for each country in which the Licensed Product is being sold;

(iv) an accounting of the permitted deductions from gross sales on a country by country basis; and

(v) the Royalties calculated on a per country basis,

(the, Royalty Report).

(b) The Royalty Report referred to in this clause 5.2 shall be in electronic form. The financial data in the Royalty Report will include calculations in the local currency for each relevant country, and US Dollars.

(c) Oasmia must provide with each Royalty Report evidence, to the reasonable satisfaction of Kazia, to support all amounts set out in the Royalty Report.

(d) Within 10 Business Days after the date on which the Royalty Report is given to Kazia (Objection Period), Kazia may dispute any amount set out in the Royalty Report by giving notice (Objection Notice) to Oasmia stating the amount or amounts in dispute and the reasons for that dispute (Royalty Dispute).

(e) If at the end of the Objection Period there is no Royalty Dispute, all amounts set out in the Royalty Report are final and binding on the parties.

(f) If an Objection Notice is given, then Kazia and Oasmia must use their reasonable endeavours to resolve the Royalty Dispute between themselves. If Kazia and Oasmia are unable to resolve the Royalty Dispute within 5 Business Days after the Objection Notice is given, the parties must refer the Royalty Dispute to an Expert in accordance with, and for determination in accordance with, Schedule 5.

(g) If there is a Royalty Dispute but it is not resolved by the parties nor referred to an Expert in accordance with clause 5.2(f), all amounts set out in the Royalty Report are final and binding on the parties, the Royalty Dispute is taken to be resolved and payments are to be made in accordance with the timing set out in clause 6.2.

(h) If there is a Royalty Dispute which is resolved by the parties or by an Expert in accordance with Schedule 5, Oasmia must pay to Kazia the Royalty amounts due in accordance with Part B of Schedule 1 in respect of Net Sales made during the period of the relevant Royalty Report based on the Royalty Report amounts agreed between the parties or determined by the Expert (as applicable) within 10 Business Days of such agreement or determination.

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Development and Commercialisation Licence Agreement

6 Payment

6.1 Upfront fee

In consideration of the grant of the Licence and other rights granted pursuant to this Agreement in relation to the Development of the Licensed Product, Oasmia shall pay to Kazia the amount set out in Part A of Schedule 1 within 30 Business Days of receipt of a valid invoice from Kazia.

6.2 Royalty

Subject to the issue of a valid invoice by Kazia and clause 5.2(h) within 30 Business Days of issue of the Royalty Report in accordance with clause 5.2(a) Oasmia must pay to Kazia an amount equal to the Royalty set out in Part B of Schedule 1 in respect of Net Sales made during the period of the relevant Royalty Report.

6.3 Milestone Payments

(a) In consideration of the rights granted pursuant to this Agreement, where a regulatory or commercial milestone as set out in column 1 of the table in Part C of Schedule 1 is satisfied, Oasmia must pay to Kazia the corresponding Milestone Payment as set out in columns 2 and 3 (as applicable) of the table in Part C of Schedule 1 within 30 Business Days of receipt of a valid invoice with respect to the same from Kazia.

(b) Notwithstanding clause 6.3(a), if for any reason the Milestone Payment relating to a phase Ill study (being the Milestone Payment corresponding to the first regulatory milestone) has not been paid at the time a new drug application is submitted to the FDA, Oasmia agrees that that Milestone Payment as set out in Schedule 1 becomes due and payable within 30 Business Days of receipt of a valid invoice with respect to the same from Kazia.

6.4 Payment requirements

All payments under this Agreement shall be:

(a) deposited by electronic funds transferred to Kazia’s nominated bank account, as notified to Oasmia in writing; and

(b) made in US dollars.

6.5 Default in payment

Notwithstanding any other provision of this Agreement, if a party defaults in the payment of any money payable under this Agreement for a period of more than 5 Business Days, then the non-defaulting party may charge interest on the amount outstanding at the Interest Rate, calculated from and including the date on which the payment became due until but excluding the date on which the payment is made, which interest is payable on the non-defaulting party making written demand to that effect.

6.6 No deductions

Subject to clause 12.4, as between the parties, Oasmia is solely responsible for payment of any fee, royalty or other payment due to any third party in connection with the research, development, manufacture, distribution, use, sale, import or export of a Licensed Product, and Oasmia shall not have the right to offset any amounts paid to such third party, including fee, royalty or other payment, against any amount payable to Kazia under this Agreement.

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Development and Commercialisation Licence Agreement

7 Alliance Manager

(a) Each party shall appoint one alliance manager who possesses a general understanding of development, manufacturing and marketing issues in relation to the Licensed Product (each an Alliance Manager), who will be dedicated to coordinating the activities of the parties under this Agreement and to act as a liaison with the other party.

(b) The Alliance Managers are responsible for:

(i) facilitating the flow of information, and otherwise promoting communication and coordination, between the parties;

(ii) coordinating with the other party on practical issues; and

(iii) providing a point of communication for seeking consensus both within the respective party’s organisation and with the other party’s organisation regarding material issues under this Agreement.

8 Obligations

8.1 Mutual obligations

(a) Without limiting clause 21, the parties shall exercise good faith to resolve business, financial and commercial issues that are encountered during the performance of this Agreement.

(b) Throughout the Term of this Agreement, the parties agree to cooperate, through their respective Alliance Managers, in good faith to ensure the performance of each parties’ obligations under this Agreement.

8.2 Oasmia’s responsibilities

(a) Oasmia is responsible for:

(i) Development strategies for the Licensed Product;

(ii) the performance of Development activities with respect to the Licensed Product;

(iii) ensuring that the Development activities with respect to the Licensed Product are consistent with all Applicable Laws;

(iv) obtaining and maintaining regulatory approvals pursuant to clause 9;

(v) Commercialisation strategies for the Licensed Product;

(vi) the performance of marketing activities with respect to the Licensed Product;

(vii) market access and pricing with respect to the Licensed Product; and

(viii) ensuring that the Commercialisation activities with respect to the Licensed Product are consistent with any Marketing Approvals and all Applicable Laws.

(b) On and from the Effective Date, Oasmia shall assume full responsibility for all activities related to the Manufacturing, Development and Commercialisation of the Licensed Product.

8.3 Kazia’s responsibilities

(a) The parties agree Kazia will be solely responsible for all Liabilities directly incurred, suffered or sustained by Oasmia and its Affiliates, directors, officers, employees, servants and agents as a result of or in connection with the Development, Commercialisation, sale or any other use of the Licensed Products by Oasmia, Kazia or any of their Affiliates, or any third party prior to the Effective Date.

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(b) The parties agree Oasmia will be solely responsible for all Liabilities directly incurred, suffered or sustained by Kazia and its Affiliates, directors, officers, employees, servants and agents as a result of or in connection with the Development, Commercialisation, sale or any other use of the Licensed Products by Oasmia, Kazia or any of their Affiliates, or any third party after the Effective Date. [***].

(c) On and from the Effective Date, the parties agree Kazia shall not be responsible (financially, operationally or otherwise) for conducting, managing, controlling or participating in any activities related to the Licensed Product, except as specifically set out in this Agreement.

9 Governmental Matters

9.1 Regulatory approvals

(a) On and from the Effective Date, Oasmia is responsible for obtaining and maintaining all necessary approvals from governmental authorities for Oasmia to Develop, Manufacture, Commercialise, market and sell the Licensed Products anywhere in the Territory, and for Oasmia to otherwise exploit the Licence granted pursuant to this Agreement. All such regulatory filings made or filed, and all permits and clearances obtained, by Oasmia will be owned exclusively by Oasmia.

(b) Kazia grants to Oasmia, their Affiliates and any sub-licensee a right of reference to any regulatory filings relating to the Licensed Product as at the Effective Date.

10 Prosecution, Proceedings and Protection of Rights

10.1 Prosecution and maintenance of Kazia Patents

(a) As between the parties, Kazia shall, in the first instance, be responsible for the preparation, filing, prosecution and maintenance of the Kazia Patents within the Territory, such responsibility extending solely to filing, prosecution and maintenance of and relating to the patents set out in Schedule 2 within the applicable jurisdiction for each respective patent as set out in column 1 of the table in Schedule 2.

(b) In fulfilling its responsibilities under clause 10.1(a), Kazia must use Commercially Reasonable Efforts to prepare, file, prosecute and maintain at its cost the Kazia Patents within the Territory, such responsibility extending solely to using Commercially Reasonable Efforts to prepare, file, prosecute and maintain the patents set out in Schedule 2 within the applicable jurisdiction for each respective patent as set out in column 1 of the table in Schedule 2. Kazia may elect not to prepare, file, prosecute or maintain any of the Kazia Patents, provided that it obtains Oasmia’s prior written consent, which must not be unreasonably withheld.

(c) If Kazia elects and Oasmia consents, in accordance with clause 10.1(b), not to prosecute and/or maintain any Kazia Patents in any country in the Territory or Oasmia wishes to prosecute and/or maintain any Kazia Patents in a country in the Territory in addition to those set out in column 1 of the table in Schedule 2 with respect to the relevant patent, Oasmia may undertake the prosecution and maintenance of such patents in the relevant jurisdiction in the Territory. Kazia must be given an opportunity to review and comment on correspondence with the patent offices, and Oasmia must incorporate Kazia’s reasonable comments. All costs (including outside counsel, annuities and other official fees) of preparing, filing, prosecuting and maintaining such patents in any jurisdiction in the Territory shall be borne solely by Oasmia.

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(d) For the avoidance of doubt, for the purposes of this Agreement, any patents prosecuted or maintained by Oasmia in accordance with clause 10.1(c) will constitute Kazia Patents.

(e) Where clause 10.1(c) applies, Kazia must provide to Oasmia reasonable assistance as Oasmia may reasonably require from time to time in relation to maintaining and prosecuting registration of the applicable Kazia Patents in the relevant jurisdictions and not oppose or encourage or assist any person to oppose a grant or renewal of a registration in respect of the Kazia Patents, nor encourage or assist any person to dispute or challenge the validity of the Kazia Patents.

10.2 Notification of Claims

Either party must notify the other party immediately if it receives any notice of:

(a) any actual or threatened infringements of the Kazia Patents or Associated Intellectual Property; or

(b) any allegation (written or otherwise) that the use of the Kazia Patents, Associated Intellectual Property or Licensed Product infringes any third party rights.

10.3 [***]

10.4 [***]

10.5 [***]

10.6 [***]

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Development and Commercialisation Licence Agreement

10.7 [***]

10.8 [***]

11 Warranties and Indemnities

11.1 Representations and warranties by the parties

Each party represents and warrants to the other parties that:

(a) it has full legal capacity and power to enter into this Agreement and to perform its obligations under this Agreement;

(b) it has taken all corporate action (if any) that is necessary or desirable to authorise its entry into this Agreement and to perform its obligations under this Agreement;

(c) this Agreement constitutes its legal, valid and binding obligations, enforceable against it in accordance with its terms (except to the extent limited by equitable principles and laws affecting creditors’ rights generally);

(d) neither its execution of this Agreement nor the carrying out by it of its obligations under this Agreement, does or will contravene any law to which it is subject or any order of any government agency or other person that is binding on it, contravene any undertaking or instrument binding on it, or contravene its constitution;

(e) there are no actions, claims, proceedings or investigations pending or threatened against it or by, against or before any person that may have a material effect on the subject matter of this Agreement; and

(f) it is not the subject of an Insolvency Event.

11.2 Representations and warranties by Kazia

Kazia represents and warrants to Oasmia that:

(a) Kazia and its Affiliates are the legal and beneficial owner of the Kazia Patents and Associated Intellectual Property and Kazia has the right to grant to Oasmia the Licence as set out in this Agreement in respect of the Kazia Patents and Associated Intellectual Property, free of all restrictions, liens, charges, encumbrances or other rights;

(b) to the best of its knowledge, any information provided in the Cantrixil Dossier and in relation to the Kazia Know-How is complete, adequate, true and accurate;

(c) the graphical representation in Part 2 of Schedule 2 accurately depicts the chemical structure of Cantrixil;

(d) subject to clause 11.8 and to the best of its knowledge, the Kazia Patents and Associated Intellectual Property are valid and enforceable and are not being, and have not been, infringed, and there is no matter, fact or circumstance which would, or would be likely to. render the Kazia Patents or Associated Intellectual Property void or voidable on any grounds;

(e) subject to clause 11.8 and to the best of its knowledge, the Development, Manufacturing or Commercialisation of the Licensed Product the subject of the Kazia Patents and Associated Intellectual Property by Oasmia in accordance with this Agreement will not infringe any right of any third party nor give rise to a right entitling any third party to make a claim against Oasmia, any of its Affiliates, or any sub-licensee or subcontractor of Oasmia, whether for the payment of compensation, royalties or otherwise;

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Development and Commercialisation Licence Agreement

(f) to the best of its knowledge, none of Kazia or any of its Affiliates have transferred, assigned or granted to any person any right, licence under or interest in the Kazia Patents or Associated Intellectual Property or which is inconsistent with the Licence as set out in this Agreement; and

11.3 Representations and warranties by Oasmia

Oasmia represents and warrants that, as at the Effective Date and on each day during the Term, in conducting activities contemplated under this Agreement, Oasmia will:

(a) comply with all Applicable Laws including those related to the manufacture, use, labelling, importation and marketing of Licensed Products; and

(b) not undertake any act or omission which will, or will have the likely effect to, bring Kazia, the Licensed Product, the Kazia Patents or the Associated Intellectual Property into disrepute.

11.4 Warranties separate

Each of the warranties is a separate and independent warranty and is not to be construed by reference to, or limited by, any other warranty.

11.5 No other representations or warranties

Except for the warranties expressly made in this Agreement, all conditions, warranties, undertakings or representations, express or implied, arising by statute, general law or otherwise are expressly excluded to the extent permitted by law. In particular, with respect to warranties given by Kazia, subject to the express warranties granted in clause 11.2, nothing in this Agreement is or will be construed as:

(a) a warranty or representation by Kazia as to the validity or scope of any claim or patent or patent application within the Kazia Patents and Associated Intellectual Property rights;

(b) a warranty or representation by Kazia that anything made, used, sold, or otherwise disposed of under any licence granted in this Agreement is or will be free from infringement of any patent rights or other intellectual property right of any third party; and

(c) a grant by Kazia, whether by implication, estoppel, or otherwise, of any licenses or rights other than that expressly granted under this Agreement.

11.6 Period of warranties and indemnity

Each of the warranties and the indemnity contained in this clause 11 are continuing obligations.

11.7 Reliance

Each party acknowledges that the other parties have executed this Agreement and agreed to take part in the transactions that this Agreement contemplates in reliance on the representations and warranties that are expressly made in this Agreement.

11.8 [***]

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Development and Commercialisation Licence Agreement

12 Indemnities and Liability

12.1 [***]

12.2 [***]

12.3 Exclusions

(a) TO THE EXTENT PERMISSIBLE BY LAW, OTHER THAN AS SET FORTH IN THIS AGREEMENT, NO WARRANTY IS GIVEN WITH RESPECT TO MATERIALS, OR THE ASSOCIATED INTELLECTUAL PROPERTY, EXPRESS OR IMP LIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND THE PARTIES SPECIFICALLY DISCLAIM ANY EXPRESS OR IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OF THE ASSOCIATED INTELLECTUAL PROPERTY, OR NON-INFRINGEMENT OF THE INTELLECTUAL PROPERTY OR OTHER RIGHTS OF ANY THIRD PARTY. THE WARRANTIES SET FORTH IN CLAUSE 11 ARE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, VALIDITY, NON-INFRINGEMENT AND ALL SUCH OTHER WARRANTIES ARE HEREBY EXPRESSLY DISCLAIMED.

(b) NOTWITHSTANDING ANYTHING CONTAINED IN THIS AGREEMENT TO THE CONTRARY, IN NO EVENT, SAVE FOR ANY LIABILITY STEMMING FROM DEATH OR PERSONAL INJURY, SHALL EITHER PARTY BE LIABLE FOR ANY SPECIAL, CONSEQUENTIAL OR INCIDENTAL DAMAGES (INCLUDING LOSS OF PROFITS) WHETHER BASED UPON BREACH OF WARRANTY, BREACH OF CONTRACT, NEGLIGENCE, STRICT TORT OR ANY OTHER LEGAL THEORY.

(c) TO THE EXTENT PERMISSIBLE BY LAW, AND SAVE FOR ANY LIABILITY STEMMING FROM DEATH OR PERSONAL INJURY, THE MAXIMUM AMOUNT THAT OASMIA MAY RECOVER FROM KAZIA FOR ANY LIABILITY UNDER THIS AGREEMENT IS THE TOTAL AMOUNT PAID UNDER THE AGREEMENT AT THE POINT OF TIME THE LIABILITY ARISES.

12.4 [***]

13 Insurance

13.1 Obligation to insure

(a) Oasmia must effect and maintain on an ongoing basis throughout the Term and the period of time required under clause 13.2, at its own expense, the following insurance coverages:

(i) commercial general liability insurance, including contractual liability and products liability insurance, in the minimum amount of [***] in aggregate, combined single limit for bodily injury and property damage liability, increasing to [***] in aggregate, combined single limit for bodily injury and property damage liability upon the first commercial sale of a Licensed Product. The deductible shall not be greater than [***] in the US and Canada combined and [***] in the rest of the world outside of the US and Canada; and

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(ii) statutory workers’ compensation coverage, where limits and employers liability limits shall be at a minimum amount of [***].

(b) Oasmia as sponsor of clinical trials with the Licensed Product must effect and maintain, at its own expense for the whole duration of the clinical trial, liability insurance with minimum limits and conditions as legally required in the jurisdiction of the trial in the Territory. For all countries in the Territory with non-defined minimum insurance limits, Oasmia shall acquire local insurance on a country-by-country basis at the statutory level, as required by local Applicable Laws, save that where there is no level established by statute, the minimum insurance limit shall be based on the local standards and practices of the jurisdiction and will be presented by Oasmia to Kazia for approval, which is not to be unreasonably withheld. This insurance shall be primary insurance.

13.2 Requirements for insurance policies

(a) All insurance coverage required pursuant to clause 13.1 must be primary insurance with respectto Oasmia’s own participation under this Agreement, and must be maintained with an insurance company or companies having an A.M. Best’s rating of A-VII or better.

(b) Oasmia must name Kazia as an additional insured by endorsement under its commercial general liability and products liability insurance policies.

(c) The insurance policies must be in aggregate and Oasmia must maintain the insurance coverage for at least 5 years following completing performance of its obligations under this Agreement.

13.3 Evidence of currency

(a) No later than 30 days after the Effective Date, Oasmia must provide to Kazia a copy of the insurance policies required to be held by Oasmia pursuant to clause 13.1 and certificates of currency with respect to such insurance policies.

(b) Oasmia must provide to Kazia at least 30 days prior written notice of any cancellation, nonrenewal or material change in any of the insurance policies required to be held by Oasmia pursuant to clause 13.1.

(c) Oasmia must, upon receipt of written requestfrom Kazia, provide renewal certificates to Kazia in relation to the insurance policies required to be held by Oasmia pursuant to clause 13.1 for as long as Oasmia is required to maintain insurance coverage under this Agreement.

14 Records and Audit

14.1 Records

(a) Oasmia shall keep complete and accurate records of its compliance with its obligations under this Agreement, and its and its sublicensees’ sales, transfers, and other dispositions of Licensed Product necessary for the calculation of payments to be made to Kazia hereunder.

(b) Oasmia shall maintain such records for the longer of:

(i) the period of time required by any Applicable Law; or

(ii) 3 years following expiration or termination of this Agreement.

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Development and Commercialisation Licence Agreement

14.2 Audit

(a) Kazia may at any time, but, subject to clause 14.2(b), not to exceed more than once in a 12 month period, nominate an independent certified public accountant or other third party (as appropriate) (Auditor) whom Oasmia shall, no later than 10 Business Days of Kazia’s notice of the same, permit to have access to Oasmia’s records during Oasmia’s normal business hours for the purpose of verifying all payments made under this Agreement and I or compliance with Oasmia’s obligations under this Agreement more generally.

(b) Where Kazia, acting reasonably, suspects that Oasmia may be in breach of any of its obligations under this Agreement, Kazia may require Oasmia to submit to an audit in accordance with clause 14.2(a) notwithstanding there may have already been one or more audits during the relevant 12 month period.

(c) Where the Auditor’s audit report shows that:

(i) payments made by Oasmia are deficient, Oasmia shall pay Kazia the deficient amount within 30 days after Kazia’s notice to Oasmia of the same; or

(ii) Oasmia is in breach of its obligations under this Agreement, the parties will promptly meet to agree a remediation plan such that any breach by Oasmia may be remedied,

provided, however, that Kazia provides to Oasmia reasonable evidence of the relevant findings set out in the Auditor’s audit report.

(d) The costs of any audit under this clause 14.2 must be borne by Kazia unless the Auditor’s audit report shows that:

(i) payments made by Oasmia are deficient; or

(ii) Oasmia is in breach of its obligations under this Agreement,

in which case the costs of the relevant audit will be borne by Oasmia.

15 Reporting

(a) Within 30 days after the end of each June and December during the Term, Oasmia will update Kazia in relation to its progress on its activities under this Agreement. Such updates shall take the form of a written report detailing:

(i) the Development and Commercialization of the Licensed Product by Oasmia during the preceding 6 month period;

(ii) the status of all progressing and planned clinical studies related to the Kazia Patents and Associated Intellectual Property, including timelines for initiation and completion of such clinical studies; and

(iii) a summary of Oasmia’s plans for the Development and Commercialisation of the Licensed Product in the next 6 months.

(b) All reports provided by Oasmia to Kazia in accordance with clause 15(a) must be sufficiently detailed for Kazia to ascertain whether Oasmia is using Commercially Reasonable Efforts to Develop and Commercialise the Licensed Product.

(c) Notwithstanding the frequency of the reporting in accordance with clause 15(a), Oasmia must inform Kazia immediately upon the achievement of a milestone listed in Schedule 1.

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Development and Commercialisation Licence Agreement

16 Term and Termination

16.1 Term

(a) The Licence and this Agreement commences on the Effective Date, as relates to each of the Kazia Patents, [***](Term).

(b) For the avoidance of doubt, the expiry of the Licence as it relates to any one of the Kazia Patents will not affect the Licence as it relates to any of the other Kazia Patents and the Licence will survive any such expiry to that extent.

16.2 Termination by either party

Subject to completion of the dispute resolution processes under clause 21, either party may immediately terminate this Agreement in writing, by giving the other party written notice, where the other Party:

(a) undergoes an Insolvency Event (regardless of whether that Insolvency Event is continuing); or

(b) commits a material breach of this Agreement, unless the breach is capable of remedy, in which case the other party may terminate this Agreement if the party who has committed that material breach has not remedied the material breach within 30 days after being required in writing to do so. Such written notice shall indicate the nature of the breach and any remedial action required to be taken.

16.3 Termination by Oasmia

Subject to completion of the dispute resolution processes under clause 21, Oasmia may immediately terminate this Agreement by notice in writing if:

(a) the Kazia Patents are revoked or abandoned, or otherwise cease to be in force for any reason other than the expiry of its statutory term; or

(b) Kazia breaches any of its representations and warranties under clause 11 above.

16.4 Termination by Kazia

Subject to completion of the dispute resolution processes under clause 21, Kazia may immediately terminate this Agreement by notice in writing if Oasmia:

(a) breaches any of its representations and warranties under clause 11 above;

(b) through a failure to use Commercially Reasonable Efforts breaches any of its obligations under clause 8.2, unless the breach is capable of remedy, in which case Kazia may terminate this Agreement if Oasmia has not remedied the breach within thirty days after being required in writing to do so. Such written notice shall indicate the nature of the breach and any remedial action required to be taken; or

(c) breaches any of its obligations under clauses 5 or 6, unless the breach is capable of remedy, in which case Kazia may terminate this Agreement if Oasmia has not remedied the breach within thirty days after being required in writing to do so. Such written notice shall indicate the nature of the breach and any remedial action required to be taken.

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Development and Commercialisation Licence Agreement

16.5 General consequences of termination and survival

Upon expiry or termination in accordance with this clause 16, this Agreement, and the Licence, is at an end as to its future operation, except for:

(a) any rights of any party which have accrued as at the date of expiry or termination; and

(b) the rights and obligations of the parties under clauses 10.2, 10.8, 12, 14, 17, 18, 19 and 23 (except 23(a)), which survive termination.

16.6 Specific consequences of termination

(a) On termination or expiry of this Agreement:

(i) Oasmia must pay to Kazia in accordance with the terms of this Agreement any unpaid invoices submitted before termination and any invoices properly submitted by Kazia after termination in accordance with clause 6;

(ii) all rights and licenses granted to Oasmia under this Agreement will immediately terminate;

(iii) Oasmia must use its best endeavours to either transfer to Kazia, or assist Kazia to obtain, all necessary approvals from governmental authorities for Kazia to Develop, Manufacture, Commercialise, market and sell the Licensed Products anywhere in the Territory;

(iv) as soon as reasonably practicable, Oasmia must Transfer to Kazia, in its entirety, the Kazia Know-How and Cantrixil Dossier, as both have been amended and updated by Oasmia over the course of the Term, along with (for the avoidance of doubt) all Know-How necessary for Kazia to exploit the licence granted to it under clause 3.4(c), such that Kazia receives the most current and up to date Know-How and dossier relevant to the Licensed Product and is in a position to exploit the licence granted under clause 3.4(c);

(v) Oasmia must discontinue making any representation regarding its status as a licensee of Kazia for all Licensed Products;

(vi) Oasmia must cease conducting any activities with respect to the marketing, promotion, sale or distribution of Licensed Products including ceasing all Manufacturing, Development and Commercialisation; and

(vii) all rights granted under this Agreement will revert to Kazia.

(b) For the avoidance of doubt, the parties agree to provide reasonable run off and transitional assistance if a clinical trial is ongoing as at the date of termination of this Agreement, to ensure trial participants affected by termination receive adequate medical care.

17 Assignment

17.1 Assignment by Oasmia

Kazia acknowledges that Oasmia is entitled to assign any or all of its rights or obligations under this Agreement to any of its Affiliates or any other third party, including in relation to any restructure, sale of assets or change of control, without Kazia‘s consent.

17.2 Assignment by Kazia

Oasmia acknowledges that Kazia is entitled to assign any or all of its rights or obligations under this Agreement to any of its Affiliates or any other third party, including in relation to any restructure or sale of assets, without Oasmia’s consent.

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Development and Commercialisation Licence Agreement

18 Confidentiality

18.1 Obligations of confidentiality

Subject to clauses 18.2 and 18.3, the Receiving Party must:

(a) keep the Confidential Information confidential and not directly or indirectly disclose, divulge or communicate any Confidential Information to, or otherwise place any Confidential Information at the disposal of, any other person without the prior written approval of the Disclosing Party;

(b) take all reasonable steps to secure and keep secure all Confidential Information coming into its possession or control as it would its own proprietary information, which in no event shall be less than a reasonable standard of care;

(c) only use the Confidential Information for the purposes of performing, and to the extent necessary to perform, its obligations under this Agreement;

(d) not deliberately memorise, modify, reverseengineer or make copies, notes or records of the Confidential Information for any purpose other than in connection with the performance by the Receiving Party of its obligations under this Agreement; and

(e) take all reasonable steps to ensure that any person to whom the Receiving Party is permitted to disclose Confidential Information under clause 18.2 complies at all times with the terms of this clause 18.

18.2 Permitted disclosure

A party may only disclose the other party’s Confidential Information:

(a) under corresponding obligations of confidence as imposed by this clause 18:

(i) to its professional advisers, auditors, bankers, insurers or insurance brokers;

(ii) to persons which Control or are Controlled by or are under common control with the party within the meaning of the Corporations Act 2001 (Cth), and the employees, professional advisers, auditors, bankers, insurers or insurance brokers of such persons; or

(b) which is at the time lawfully in the possession of the proposed recipient of the information through sources other than another party, or an Affiliate of another party;

(c) in enforcing this Agreement or in a proceeding arising out of or in connection with this Agreement;

(d) with the prior written consent of the party which originally supplied that confidential information in connection with this Agreement; or

(e) where such disclosure is necessary to comply with any court order, law, or the applicable rules of any stock exchange or financial market to which the Receiving Party or an Affiliate of that party, is subject if, to the extent practicable and as soon as reasonably possible, the Receiving Party:

(i) notifies the Disclosing Party of the proposed disclosure;

(ii) consults with the Disclosing Party as to its content;

(iii) provides the Disclosing Party a reasonable opportunity to seek a protective order or other appropriate remedy and/or to waive compliance with the provisions of this Agreement; and

(iv) uses reasonable endeavours to comply with any reasonable request by the Disclosing Party concerning the proposed disclosure.

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Development and Commercialisation Licence Agreement

18.3 Exceptions

Clause 18.1 will cease to apply to any Confidential Information to the extent it enters the public domain, other than as a result of a breach of this Agreement, or where such Confidential Information is lawfully received by the Receiving Party other than from the Disclosing Party without any obligation of confidence attaching to it.

18.4 Kazia Know-How

For the avoidance of doubt, Oasmia acknowledges that the Kazia Know-How is Confidential Information of Kazia and is subject to the obligations set out under this clause 18.

18.5 Return or destruction of Confidential Information

(a) Subject to clauses 16.6 and 18.5(b), immediately on the termination of this Agreement for any reason, a Receiving Party must:

(i) cease the use of all Confidential Information of or relating to the Disclosing Party (or any Affiliate of the Disclosing Party);

(ii) deliver to the Disclosing Party all documents and other materials in its possession or control containing, recording or constituting that Confidential Information or, at the option of the Disclosing Party, destroy, and certify to the Disclosing Party that it has destroyed, those documents and materials; and

(iii) for Confidential Information stored electronically, permanently delete that Confidential Information from all electronic media on which it is stored, so that it cannot be restored.

(b) A Receiving Party shall be permitted to retain a copy (or copies, as necessary) of Confidential Information of or relating to the Disclosing Party which the Receiving Party has the right to retain under this Agreement, or otherwise for archival purposes or as required by any Applicable Law.

18.6 Liability for breach by recipient

The Receiving Party is liable for any breach of this clause 18 by a recipient of Confidential Information which is provided such information in accordance with clause 18.2(a), as if that recipient was a Receiving Party in relation to the Confidential Information disclosed to the recipient.

18.7 Survival of obligation

The obligations under this clause 18 survive the termination or expiration of this Agreement.

18.8 Public announcements

Except as required by law, a regulatory body or a stock exchange or financial market to which a party, or an Affiliate of a party, is subject, all press releases and other public announcements in connection with this Agreement must use the form of press release set out in Schedule 6 or otherwise be in terms agreed by the parties.

19 Costs and duty

Each party must bear its own costs arising out of the negotiation, preparation and execution of this Agreement. All duty (including stamp duty and any fines, penalties and interest) payable on or in connection with this Agreement and any instrument executed under or any transaction evidenced by this Agreement must be borne equally by Kazia and Oasmia.

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Development and Commercialisation Licence Agreement

20 Notice

Any notice, demand, consent or other communication (a Notice) given or made under this Agreement:

(a) must be in writing and signed by the sender or a person duly authorised by the sender (or in the case of email, set out the full name and position or title of the sender or person duly authorised by the sender);

(b) must be delivered to the intended recipient by prepaid post (if posted to an address in another country, by registered airmail) or by hand or email to the address or email address below or the address or email address last notified by the intended recipient to the sender:

(i)	to Oasmia:	Oasmia Pharmaceutical AB
		Address: Vallongatan 1, 752 28 Uppsala,
		Sweden
		Attention: General Counsel
	with a copy to	Allens
		Address: Level 4, 126 Phillip St Sydney
		NSW2000
		Email: [***]Attention: [***]
		Kazia Therapeutics Limited
(ii)	to Kazia:	Address: Level 24, 300 Barangaroo
		Avenue, Sydney, New South
		Wales, Australia 2000
		Email:      [***]
		Attention: CEO
	with a copy to	K&L Gates
		Address: Level 25 South Tower, 525
		Collins Street Melbourne,
		Australia 3000
		Email: [***]Attention: [***]

(c) will be conclusively taken to be duly given or made and received:

(i) in the case of delivery in person, when delivered;

(ii) in the case of delivery by express post, to an address in the same country, two Business Days after the date of posting;

(iii) in the case of delivery by any other method of post, six Business Days after the date of posting (if posted to an address in the same country) or 10 Business Days after the date of posting (if posted to an address in another country); and

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Development and Commercialisation Licence Agreement

(iv) in the case of email, at the earliest of:

(A) the time that the sender receives an automated message from the intended recipient’s information system confirming delivery of the email;

(B) the time that the intended recipient confirms receipt of the email by reply email; and

(C) three hours after the time the email is sent (as recorded on the device from which the sender sent the email) unless the sender receives, an automated message that the email has not been delivered,

but if the result is that a Notice would be taken to be given or made and received:

(v) in the case of delivery by hand or post, at a time that is later than 5 pm;

(vi) in the case of delivery by email, at a time that is later than 7 pm; or

(vii) on a day that is not a Business Day,

in the place specified by the intended recipient as its postal address under clause 20(b), it will be conclusively taken to have been duly given or made and received at the start of business on the next Business Day in that place.

21 Dispute Resolution

21.1 Parties to attempt resolution

If a dispute arises relating to or arising out of this Agreement, the parties must first attempt to resolve that dispute in accordance with this clause 21.

21.2 Meeting between Alliance Managers

As soon as reasonably practicable following the written notification by the Alliance Manager of one party to the Alliance Manager of the other party of a dispute, the Alliance Managers must meet and use all reasonable endeavours acting in good faith to resolve the dispute by joint discussions.

21.3 Negotiations

If the Alliance Managers are unable to resolve the dispute within 20 Business Days after the delivery of the written notice, senior executives of each party must meet as soon as is reasonably practicable, and no later than 10 Business Days following notice from the Alliance Managers of their failure to resolve the dispute, and use all reasonable endeavours acting in good faith to resolve the dispute by negotiation. If the parties are unable to resolve the dispute within 20 Business Days of the negotiation, the dispute must promptly be submitted for arbitration in accordance with, and subject to, the Resolution Institute Arbitration Rules, should either party wish to press for resolution of the dispute further.

21.4 Arbitration

(a) The arbitrator will be an independent person agreed between the parties within 14 days of the names of one or more independent persons being proposed by either party or, failing agreement, within 21 days of the proposal an arbitrator will be appointed by the Resolut ion Institute in accordance with article 8(3) of the Resolution Institute Arbitration Rules 2020.

(b) The arbitration will be conducted and held in accordance with the laws of New South Wales.

(c) The arbitration will be held in Sydney.

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Development and Commercialisation Licence Agreement

(d) The parties will each bear their own costs with respect to any arbitration and the costs of the arbitrator will be allocated equally between the parties.

(e) The parties agree that an appeal may be made to the court on a question of law.

21.5 Continuation of rights and obligations

Despite the existence of a dispute or difference, each party must continue to perform this Agreement.

22 Force Majeure

22.1 Event of Force Majeure

If a party is prevented in whole or in part from carrying out its obligations under this Agreement (other than an obligation to pay money) as a result of Force Majeure, it must promptly give a notice to the other party that complies with clause 22.2.

Following this notice, and while the Force Majeure continues, the obligations which cannot be performed (other than an obligation to pay money) because of the Force Majeure will be suspended if the party giving notice has taken all proper precautions, due care and reasonable alternatives with the intention of avoiding the delay or failure and of carrying out its obligations under this Agreement.

22.2 Force Majeure notice

A notice given under clause 22.1 must:

(a) specify the obligations a party cannot perform;

(b) fully describe the event of Force Majeure; and

(c) estimate the time during which the Force Majeure will continue.

22.3 Remedy of Force Majeure

The party that is prevented from carrying out its obligations under this Agreement as a result of Force Majeure must seek to mitigate the effects of the Force Majeure to the extent reasonably practicable and resume performance of its obligations as soon as reasonably possible.

22.4 Mitigation

The party that is prevented from carrying out its obligations under this Agreement as a result of Force Majeure must take all action reasonably practicable to mitigate any loss suffered by a party or a third party as a result of its failure to carry out its obligations under this Agreement.

22.5 No requirement to settle labour dispute

A party is not required, under clause 22.1, 22.2 or 22.3, to settle any labour dispute against its will.

22.6 No extension of Term

The Term will not be extended by the period of Force Majeure.

23 General

(a) Each party must do anything necessary or desirable (including executing agreements and documents) to give full effect to this Agreement and the transactions contemplated by it.

(b) This Agreement may be amended only by another Agreement executed by all of the parties.

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Development and Commercialisation Licence Agreement

(c) Any provision of this Agreement that is prohibited or unenforceable in any jurisdiction is ineffective as to that jurisdiction to the extent of the prohibition or unenforceability. That does not invalidate the remaining provisions of this Agreement nor affect the validity or enforceability of that provision in any other jurisdiction.

(d) A failure to exercise or a delay in exercising any right, power or remedy under this Agreement does not operate as a waiver. A single or partial exercise or waiver of the exercise of any right, power or remedy does not preclude any other or further exercise of that or any other right, power or remedy. A waiver is not valid or binding on the party granting that waiver unless made in writing. For the avoidance of doubt, the doctrine of affirmation by election will not apply to any failure by a party to exercise, or delay by a party in exercising, any right, power or remedy under this Agreement.

(e) This Agreement contains the entire agreement between the parties with respect to its subject matter. It sets out the only conduct, representations, warranties, covenants, conditions, agreements or understandings (collectively Conduct) relied on by the parties and supersedes all earlier Conduct by or between the parties in connection with its subject matter. No party has relied on or is relying on any other Conduct in entering into this Agreement and completing the transactions contemplated by it.

(f) Nothing in this Agreement is to be construed as constituting an agency, partnership, joint venture, or any other form of association between the parties in which one party may be liable for the acts or omissions of any other party. No party has the authority to incur any obligation or make any representation or warranty on behalf of, or to pledge the credit of, any other party.

(g) This Agreement may be executed in any number of counterparts. All counterparts together will be taken to constitute one instrument.

(h) This Agreement is governed by the laws of New South Wales. In relation to this Agreement and related non-contractual matters, subject to clause 21, each party irrevocably submits to the non-exclusive jurisdiction of courts with jurisdiction there, and waives any right to object to the venue on any ground.

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Development and Commercialisation Licence Agreement

Schedule 1

Upfront fee, Milestone Payments and Royalty

Part A. Upfront fee (cl 6.1)

	Ovarian cancer indication	Each successive indication
Upfront Fee	US$4 million

Part B. Royalty (cl 6.2)

	Ovarian cancer indication	Each successive indication
Royalty	[***]	[***]

Part C. Milestone Payments (cl 6.3)

	Ovarian cancer indication	Each successive indication
Regulatory milestone
[***]	[***][***]	[***]
Commercial milestone fee(s)
[***]
	[***]

page 30

[***]

[***]

page 31

	[***]
[***]

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Development and Commercialisation Licence Agreement

[***]

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Development and Commercialisation Licence Agreement

Schedule 4

Assistance to be provided by Kazia

Within 3 months from Effective Date

[***]

Within Six Months from Effective Date

Activity

[***]

[***]

[***]

First Eighteen Months from Effective Date

Activity

[***]

[***]

* Note

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Development and Commercialisation Licence Agreement

All Activities outlined in this schedule will be pursued on the basis of Commercially Reasonable Efforts, but no warranty or commitment can be provided as to outcome or timing. The parties recognise that drug development incurs inherent risk, and that the progression of any investigational new drug depends partly on emerging data, and partly on the actions of external parties such as regulatory agencies, contractors, vendors, clinicians, and researchers.

The parties will regularly communicate through their respective Alliance Managers to track progress on these objectives, and to jointly address any challenges or opportunities that emerge, and this plan may therefore evolve as the Licensed Product advances through its development.

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Development and Commercialisation Licence Agreement

Schedule 5

Expert Determination

1. Delivering a dispute notice

(a) If Oasmia and Kazia have been unable to resolve any dispute arising between them in relation to a Royalty Dispute within the period stated in clause 5.2(f), then Oasmia and Kazia may refer the Royalty Dispute to an Expert for determination in accordance with this Schedule 5.

(b) For the purposes of this Schedule 5, the Expert is a person:

(i) having appropriate qualifications and experience relevant to determining the Royalty Dispute;

(ii) who is agreed by the parties or, failing agreement within 5 Business Days, is nominated at the request of any party by the Resolution Institutein accordance with the Resolution Institute Expert Determination Rules (Rules); and

(iii) who does not act, or whose firm does not act, generally for any party.

2. Determination by Expert

The Expert:

(a) must conduct its determination in accordance with the Rules, which Rules are taken to be incorporatedinto this Agreement;

(b) will act as an expert and not as an arbitrator;

(c) may determine the time, place and procedures (which will be as informal as is consistent with the proper conduct of the matter) for the determination by the Expert, having regard to the nature of the Royalty Dispute and the provisions of this Agreement;

(d) may communicate privately with the parties or with their lawyers;

(e) may or may not allow the appearance of lawyers on behalf of the parties;

(f) may accept written submissions from a party in relation to the Royalty Dispute, provided a copy of the submission is also given to all other parties;

(g) may co-opt other expert assistance;

(h) must have regard to the fairness and reasonableness of any matters pertaining to the Royalty Dispute; and

(i) must deal with any matter as expeditiously as possible and by no later than 20 Business Days after referral to the Expert.

3. Obligations of parties

If an Expert is required to resolve a Royalty Dispute:

(a) the Expert’s determination will, except in the case of manifest error, be final and binding on the parties;

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Development and Commercialisation Licence Agreement

(b) the parties must attend the sessions with the Expert and make a determined and genuine effort to resolve the Royalty Dispute as soon as reasonably possible;

(c) without limiting item 3(b) of this Schedule 5, the parties must use their best endeavours to make available to the Expert all information relevant to the Royalty Dispute and which the Expert reasonably requires in order to resolve the Royalty Dispute;

(d) everything that occurs before the Expert must be in confidence and in closed session;

(e) all discussions must be without prejudice;

(f) each party must pay its own costs of complying with this Schedule 5 and the costs of the Expert and any other costs of complying with this Schedule 5 must be shared half as to Oasmia and half as to Kazia; and

(g) the parties must continue performing their obligations under this Agreement while the Royalty Dispute is being resolved.

4. Other proceedings

A party may not commence court proceedings in respect of a Royalty Dispute unless it has complied with the terms of the Agreement, and if applicable until the procedures in this Schedule 5 have been followed in full, except where:

(a) the party seeks injunctive relief in relation to a Royalty Dispute from an appropriate court where failure to obtain such relief would cause irreparable damage to the party concerned; or

(b) following those procedures would mean that a limitation period for a cause of action relevant to the issues in dispute will expire.

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[***]

page 38

[***]

page 39

[***]

page 40

[***]

page 41

Development and Commercialisation Licence Agreement

Executed as an Agreement

Executed as an Agreement by Oasmia

/s/ Francois Martelet

Francois Martelet, CEO

Executed in accordance with section 127 of the Corporations Act 2001 by Kazia Therapeutics Limited:

	Director/Secretary Signature
/s/ James Garner	/s/ kate Hill
James Garner	Kate Hill
Print Name	Print Name

page 42

EX-4.19

Exhibit 4.19

CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT WAS OMITTED BY MEANS OF MARKING SUCH INFORMATION WITH BRACKETS (“[***]”) BECAUSE THE IDENTIFIED CONFIDENTIAL INFORMATION IS NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

LICENSE AGREEMENT

This LICENSE AGREEMENT (the “Agreement”) is entered into on March 29, 2021 (the “Effective Date”) between:

SIMCERE PHARMACEUTICAL CO., LTD., a company organized under the laws of the People’s Republic of China and having a place of business at No.99, Huakang Road, Nanjing Jiangbei New Area, Nanjing, Jiangsu, China (“Simcere”); and

KAZIA THERAPEUTICS, LTD. (ACN 063 259 754), a company organized under the laws of New South Wales, Australia and having a place of business at Three International Towers, L24, 300 Barangaroo Avenue, Sydney, NSW 2000, Australia (“Kazia”).

Kazia and Simcere are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”

Recitals

WHEREAS, Kazia is developing paxalisib (also known as GDC-0084), a proprietary PI3K/AKT/mTOR pathway inhibitor, for the treatment of glioblastoma and certain other cancers, and owns or controls certain patent, know-how and other intellectual property rights relating to such product candidate; and

WHEREAS, Simcere wishes to obtain from Kazia, and Kazia is willing to grant to Simcere licenses to research, develop, manufacture and commercialize such product in the greater China region, all on the terms and conditions set forth herein.

NOW THEREFORE, in consideration of the foregoing premises and the mutual covenants contained herein, the receipt and sufficiency of which are hereby acknowledged, Simcere and Kazia hereby agree as follows:

ARTICLE 1

DEFINITIONS

Unless the context otherwise requires, the terms in this Agreement with initial letters capitalized, shall have the meanings set forth below, or the meaning as designated in the indicated places throughout this Agreement.

1.1    “Affiliate” means, with respect to a Party, any Person that controls, is controlled by, or is under common control with that Party. For the purpose of this definition, “control” (including, with correlative meaning, the terms “controlled by” and “under the common control”) means the actual power, either directly or indirectly through one or more intermediaries, to direct or cause the direction of the management and policies of such Person, whether by the ownership of more than fifty percent (50%) of the voting stock of such Person, by contract or otherwise.

1.2    “Claims” means all Third Party demands, claims, actions, proceedings and liability (whether criminal or civil, in contract, tort or otherwise) for losses, damages, reasonable legal costs and other reasonable expenses of any nature.

1.3    “Commercialize” or “Commercialization” means all activities directed to marketing, distributing, detailing or selling the Product (as well as importing and exporting activities in connection therewith), including all activities directed to obtaining pricing and reimbursement approvals for the Product.

1.4    “Commercially Reasonable Efforts” means, with respect to the Development and Commercialization of the Product under this Agreement, those efforts consistent with the exercise of prudent scientific and business judgment as applied by a Party to the development and commercialization of its own product that is at a similar stage of development or commercialization and has similar market potential, taking into account efficacy, safety, patent and regulatory exclusivity, anticipated or approved labeling, present and future market potential, competitive market conditions, the profitability of the product in light of pricing and reimbursement issues, and all other relevant factors. Commercially Reasonable Efforts shall be determined on a market-by-market and indication-by-indication basis, and it is anticipated that the level of effort required may be different for different markets and indications and may change over time, reflecting changes in the status of the Product and markets involved.

1.5    “Compound” means paxalisib (also known as GDC-0084) or any salt, polymorph, hydrate, solvate or metabolite, as set forth in Exhibit A.

1.6    “Confidential Information” of a Party means all Know-How, unpublished patent applications and all other information and data, including information and data of a financial, commercial, business, operational or technical nature belonging or relating to a Party or any of its Affiliates, whether made available orally, in writing, graphically, or in electronic or any other form. For the avoidance of doubt, the terms and conditions of this Agreement are the Confidential Information of both Parties.

1.7    “Control” or “Controlled” means, with respect to any Know-How, Patents or other intellectual property rights, that a Party has the legal authority or right (whether by ownership, license or otherwise) to grant a license, sublicense, access or other right (as applicable) under such Know-How, Patents, or other intellectual property rights to the other Party on the terms and conditions set forth herein, in each case without breaching the terms of any agreement with a Third Party.

1.8    “Develop” or “Development” means all development activities necessary or useful to obtain or maintain Regulatory Approval for the Product, including all non-clinical studies and clinical trials of the Product, manufacture process development, distribution of the Product for use in clinical trials (including placebos and comparators), statistical analyses, and the preparation and submission of Regulatory Materials for, and all regulatory affairs related to, the Product.

1.9    “Dollar” means U.S. dollars, and “$” shall be interpreted accordingly.

1.10    “Expert” has the meaning given to that term in Exhibit H.

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1.11    “E.U.” means the European Union and its member states, territories and possessions.

1.12    “Field” means all therapeutic uses in humans.

1.13    “First Commercial Sale” means, with respect to a Product in a region in the Territory, the first sale of such Product by Simcere, its Affiliates or sublicensees to a Third Party for distribution, use or consumption in such region after Regulatory Approval of the Product has been granted in such region.

1.14    “Genentech Agreement” means that certain Exclusive License Agreement between Kazia and Genentech, Inc. (“Genentech”), dated October 25, 2016.

1.15    “Global Clinical Trial” means a clinical trial of the Product, other than GBM AGILE:

(a)    that is conducted (in whole or in part) by or on behalf of Kazia in collaboration with an academic or non-profit collaborator (but not by Kazia itself or commercial partners of Kazia);

(b)    that is conducted in sites in multiple jurisdictions, including in the Territory and at least one of the U.S., United Kingdom, France, Germany, Italy or Spain; and

(c)    where the planned number of patients to be enrolled in the Territory does not exceed twenty percent (20%) of the planned global enrollment in such clinical trial.

For clarity, Kazia may not conduct a clinical trial of the Product in the Territory by itself or through its Affiliate or any commercial partners.

1.16    “Government Authority” means any federal, state, national, provincial or local government, or political subdivision thereof, or any organization established under statute or any authority, agency or commission entitled to exercise any administrative, executive, legislative, regulatory or taxing authority or power (or any department, bureau or division thereof, or any governmental body).

1.17    “IND” means any investigational new drug application, clinical trial application, clinical trial exemption or similar or equivalent application filed with the applicable Regulatory Authority for approval to conduct clinical testing of a pharmaceutical product in humans.

1.18    “Indication” means a separate and distinct disease, disorder or medical condition for which a Product can be used to diagnose, treat or prevent, which use is the subject of a separate MA or separate approval within the same MA. For clarity, subpopulations or patients with a primary disease or condition, however stratified, shall not be deemed to be separate “Indications” for the purposes of this Agreement, including stratification by stages or progression (including precursor condition), particular combinations of symptoms associated with the primary disease or condition, prior treatment courses, response to prior treatment, different lines of treatment, family history, clinical history, phenotype, age (e.g. adult and pediatric) or other stratification. In addition, combination treatments with the Product and another product shall not be deemed to be separate “Indication” for the purpose of this Agreement unless the Product’s purpose is to diagnose, treat or prevent a separate and distinct disease, disorder or medical condition.

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1.19    “Invention” means any data, results, discovery, finding, process, improvement, enhancement, modification, development, method, composition of matter, article of manufacture, patentable or otherwise, that is invented, reduced to practice, or otherwise generated by either Party exercising its rights or carrying out its obligations under this Agreement, whether directly or via its Affiliates, agents, contractors or sublicensees, including all rights, title and interest in and to the intellectual property rights therein.

1.20    “Know-How” means any technical, commercial, scientific, regulatory or practical information, including discoveries, improvements, modifications, processes, methods, protocols, formulas, data, inventions, know-how and trade secrets, patentable or otherwise, but excluding any Patents.

1.21    “Law” means any federal, state, local, foreign or multinational law, statute, standard, ordinance, code, rule, regulation, resolution or promulgation, the rules of the security exchange on which a Party’s or its Affiliate’s stock is publicly traded, or any order by any Government Authority, or any license, franchise, permit or similar right granted under any of the foregoing, or any similar provision having the force or effect of law.

1.22 “Licensed IP” means the Licensed Know-How and Licensed Patents.

1.23    “Licensed Know-How” means all Know-How that (a) is Controlled by Kazia or its Affiliates as of the Effective Date or at any time during the Term, and (b) is necessary or reasonably useful, but not otherwise readily available, for the Development, Manufacture or Commercialization of the Compound and Product.

1.24    “Licensed Patents” means all Patents that are Controlled by Kazia or its Affiliates as of the Effective Date or at any time during the Term, and which claim or cover the Compound or Product (including composition of matter, methods of making and using). Licensed Patents existing as of the Effective Date are set forth in Exhibit B.

1.25    “MA” or “Marketing Authorization” means a Regulatory Approval issued by an appropriate Regulatory Authority for the importation, promotion, marketing, sale and supply of a pharmaceutical product in a particular jurisdiction and all amendments and supplements thereto, including an approved New Drug Application (“NDA”) and an approved Biologic License Application (“BLA”) following filing with the Food and Drug Administration in the U.S., and equivalent foreign approvals, but excluding pricing and reimbursement approval.

1.26    “Manufacture” or “Manufacturing” means activities directed to the manufacture of the Product, including the planning, purchasing, producing, manufacturing, processing, transportation, quality assurance testing, quality control, regulatory compliance, storage, waste disposal, sample retention, formulation, stability testing, filling, packaging, labelling, leafleting, release and dispatch and such other related matters in each case as applicable to the Product.

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1.27    “Manufacturing Cost” means, with respect to the Compound and Product supplied by Kazia to Simcere hereunder:

(a)    if the Compound or Product is Manufactured by Kazia’s Third Party contract manufacturer, Kazia’s actual Third Party cost of the Manufacture and supply of such Compound or Product; and

(b)    if the Compound or Product is Manufactured by Kazia itself or its Affiliate, the actual, fully-burdened cost for the Manufacture and supply of such Compound or Product, including raw materials, direct labor and benefits, and the proportionate share of indirect Manufacturing costs. Such fully-burdened cost shall be calculated (i) if applicable, on a theoretical full-capacity basis, with the percentage allocable to Manufacturing Cost representing the number of units or runs of the Compound or Product produced or performed as a percentage of the total number of units or runs, including those of other products, that could be manufactured in such facility during a calendar year; and (ii) in accordance with applicable accounting standards consistently applied.

1.28    “Net Sales” means the gross amount received by Simcere, its Affiliates or sublicensees for sale of the Product to Third Parties (other than Simcere’s sublicensees) less the following amounts incurred or paid by the selling party in connection with the sale of the Product: (a) normal and customary trade, cash and quantity discounts or rebates; (b) credits or allowances actually granted to the customer for damaged goods, returns, recalls, rebates or rejections of the Product; (c) reasonable charges for insurance, freight, and other transportation costs directly related to the delivery of the Product to the extent such charges were included on the invoice provided to the customer; (d) taxes (including sales tax and VAT, but not income taxes), tariff, duty or governmental charges levied on the sales, transfer, transportation or delivery of the Product included on the invoice for the Product and not reimbursed directly or indirectly; (e) customary rebates and chargeback payments with respect to such Product granted to managed health care organizations, pharmacy benefit managers (or equivalents thereof), national, state, provincial, local, and other governments, their agencies and purchasers and reimbursers, or to trade customers; and (f) any other similar and customary deductions that are consistent with applicable accounting standards.

If a Product is sold in a region in the Territory as a combination of the Compound with another active pharmaceutical ingredient or component that is not a Compound (“Combination”), then the gross amount invoiced, for the purposes of determining royalty payments on the Combination, shall be calculated using one of the following alternative methods:

(i)    by multiplying the gross amount invoiced for the Combination by the fraction A/(A+B), where A is the gross amount invoiced, during the relevant reporting period, for the Product that contains the Compound as its only active ingredient (the “Mono Product”) when sold separately in such region, and B is the gross amount invoiced, during the relevant reporting period, of the other active ingredients or components in the Combination (the “Other Products”) when sold separately in such region; or

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(ii)    if no such separate sales in such region are made of any or all of the Other Products during the relevant reporting period, then the gross amount invoiced, for the purposes of determining royalty payments on the Combination, shall be calculated by multiplying the gross amount invoiced for the Combination by the fraction A/C where A is the gross amount invoiced, during the relevant reporting period, for the Mono Product when sold separately in such region (provided that if there is no separate sale of the Mono Product in such region, then A shall be estimated in good faith by Simcere), and C is the gross amount invoiced, during the relevant reporting period, for the Combination sold in such region.

Where Simcere is considering or intends to supply or sell Product in a region in the Territory as a bundle with any other product or products for the one (combined) price (“Bundle”), then Simcere must provide prior notice to Kazia, and Simcere and Kazia must agree how the price (including gross amount and Net Sales) of the Product in the Bundle should be allocated for the purposes of this Agreement prior to the first such sale or supply.

1.29    “NMPA” means National Medical Products Administration of China (formerly known as the China Food and Drug Administration), or its successor.

1.30    “Patents” means all patents and patent applications (which for the purpose of this Agreement shall be deemed to include certificates of invention and applications for certificates of invention), including all divisionals, continuations, substitutions, continuations-in-part, re- examinations, reissues, additions, renewals, revalidations, extensions, registrations, pediatric exclusivity periods and supplemental protection certificates and the like of any such patents and patent applications, and any and all foreign equivalents of the foregoing.

1.31    “Person” means any individual, partnership, limited liability company, firm, corporation, association, trust, unincorporated organization or other entity.

1.32    “Product” means any pharmaceutical product that contains a Compound as an active pharmaceutical ingredient, in any formulation or dosage form and for any mode of administration.

1.33    “Regulatory Approval” means with respect to a Product, all registrations, approvals, permits, authorizations or licenses issued by an applicable Regulatory Authority in a jurisdiction that are necessary for the Manufacture, importation, storage, promotion, marketing, sale, distribution or other Commercialization of that Product in the relevant jurisdiction (including applicable approvals of labelling for that product in that jurisdiction and any customs and tax approvals, but excluding any price and reimbursement approval) and including any amendment or supplement thereto.

1.34    “Regulatory Authority” means any applicable Government Authority responsible for granting Regulatory Approvals for the Product.

1.35    “Regulatory Material” means any regulatory application, submission, notification, communication, correspondence, registration and other filings made to, received from or otherwise conducted with a Regulatory Authority in order to Develop, Manufacture, market, sell or otherwise Commercialize the Product in a particular country or jurisdiction. For clarity, Regulatory Materials include IND, MAs (including applications for the same) and Regulatory Approvals.

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1.36    “Territory” means China, including mainland China, Hong Kong, Macao and Taiwan, [***].

1.37    “Third Party” means any Person other than a Party or an Affiliate of a Party.

1.38    “Valid Claim” means a claim of (a) an issued and unexpired Patent that has not been revoked, held invalid or unenforceable by a patent office, court or other Government Authority of competent jurisdiction in a final and non-appealable judgment (or judgment from which no appeal was taken within the allowable time period) and has not been disclaimed, denied or admitted to be invalid or unenforceable through reissue, re-examination or disclaimer, or (b) a pending patent application to the extent the claim continues to be prosecuted in good faith, has not been irretrievably cancelled, withdrawn or abandoned, and that has been pending for less than [***] years from its earliest priority date; provided that if the claim ever issues, it shall become a Valid Claim again after issuance.

1.39    “United States” or “U.S.” means the United States of America and its territories and possessions.

1.40    Interpretation. In this Agreement, unless otherwise specified:

(a)    The words “include”, “includes” and “including” shall be deemed to be followed by the phrase “without limitation”;

(b)    words denoting the singular shall include the plural and vice versa and words denoting any gender shall include all genders;

(c)    the word “or” is used in the inclusive sense typically associated with the phrase “and/or”;

(d)    words such as “herein”, “hereof”, and “hereunder” refer to this Agreement as a whole and not merely to the particular provision in which such words appear; and

(e)    the Exhibits and other attachments form part of the operative provision of this Agreement and references to this Agreement shall include references to the Exhibits and attachments.

1.41    Additional Definitions. The following table identifies the location of definitions set forth in various Sections of the Agreement:

Defined Terms	Section
ADS	5.2
Alliance Manager	3.5
Audit	5.11(b)
Auditor	5.11(b)

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Defined Terms	Section
Bankruptcy Code	6.6
Executive Officers	3.4
GCAR	4.4(a)
GBM AGILE	4.4(a)
IDL	4.5(d)
Indemnified Party	10.3
Indemnifying Party	10.3
Joint Steering Committee or JSC	3.1
Kazia Indemnitees	10.2
Licensed Trademarks	6.7(a)
Prior CDA	7.7
Product Marks	6.7(b)
Recipient	7.3
Remedial Action	4.12
Review Period	5.5(f)
Royalty Query	5.5(f)
Royalty Report	5.5(e)
Royalty Term	5.5(b)
Securities Regulators	7.6(b)
Share Subscription Agreement	5.2
Simcere Indemnitees	10.1
Territory Infringement	6.3

ARTICLE 2

LICENSE

2.1    License to Simcere. As between the parties, Kazia hereby grants Simcere and its Affiliates an exclusive (even as to Kazia and its Affiliates) and royalty bearing license for the Term (but subject to Section 8.1(a)) under the Licensed IP solely to research, Develop, make, have made, use, sell, offer for sale, have sold, import and Commercialize the Compound and Product in the Field in the Territory. Simcere acknowledges and agrees that Kazia obtained Control of certain Licensed Know-How through a non-exclusive license from Genentech under the Genentech Agreement, and therefore:

(a)    the foregoing license granted by Kazia to Simcere under such Licensed Know-How shall be exclusive with respect to Kazia and its Affiliates only; and

(b) such Licensed Know-How may be otherwise used or licensed by Genentech.

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2.2    Subcontractors and Sublicenses.

(a)    Subject to Sections 2.2(c) and 2.2(d), Simcere shall have the right to engage Third Party subcontractors in connection with the Development, Manufacture and Commercialization of the Compound and Product in the Field in the Territory, and shall have the right to grant sublicenses to its subcontractors solely in order to enable the subcontractors to perform such work for Simcere, provided that such sublicenses shall not include the right for the subcontractors to market, promote or sell the Product, unless the subcontractor serves as Simcere’s distributor or contract sales force for the Product.

(b)    Sublicenses to any Third Party whom shall serve as Simcere’s distributor or contract sales force for the Product shall require Kazia’s prior written consent, which shall not be unreasonably withheld, delayed or conditioned.

(c)    Simcere must ensure that any subcontractor or sublicensee agrees in writing to be subject to, and bound by, to the extent applicable, terms and conditions substantially similar to the terms and conditions of this Agreement. Simcere will remain responsible to Kazia for all acts performed by, and omissions of, any subcontractor or sublicensee pursuant to any subcontract or sublicense agreements as if such act or omission was undertaken by Simcere, and Simcere must ensure compliance by all subcontractors and sublicensees with the obligations of Simcere under this Agreement.

(d)    Irrespective of any subcontract or sublicense arrangement, Simcere will be responsible for the payment of all amounts due under this Agreement, regardless of whether the terms of the subcontract or sublicense arrangement provide for such amount to be paid by the subcontractor or sublicensee directly to Kazia.

2.3    License Back. Notwithstanding the exclusive (as between the parties) license granted to Simcere under Section 2.1, Simcere grants back to Kazia a royalty-free, sub- licensable, irrevocable for the Term, non-exclusive license under the Licensed IP to (a) conduct non-clinical research, GBM AGILE and other Global Clinical Trials, in each case, of the Compound and the Product in the Field in the Territory, and (b) Manufacture the Compound and Product in the Territory for export out of the Territory. For the avoidance of doubt, the Parties acknowledge that Kazia retains the exclusive right to practice, license and otherwise exploit the Licensed IP outside the scope of the license granted to Simcere under Section 2.1.

2.4    No Implied License. Except as expressly set forth herein, neither Party shall acquire any license, right or other interest, by implication or otherwise, under any intellectual property rights of the other Party.

2.5    Termination of Genentech Agreement. To the extent possible, upon the early termination of the Genentech Agreement for any reason, this Agreement will continue in full force and effect, provided that:

(a)    all rights and licenses granted by Kazia under Section 2.1 under any Licensed IP which Kazia obtained Control of through a license from Genentech under the Genentech Agreement shall terminate; and

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(b)    all necessary consequential amendments to this Agreement will be taken to have been made (including with respect to applicable representations and warranties) with effect on and from the date upon which the Genentech Agreement terminates.

ARTICLE 3

GOVERNANCE

3.1    Joint Steering Committee. Subject to Section 8.1(b), within thirty (30) days after the Effective Date, the Parties shall establish a joint steering committee (the “Joint Steering Committee” or the “JSC”), composed of two (2) senior executives of each Party (or such number of representatives as agreed by the Parties, provided that the Parties shall have equal number of representatives at the JSC), to oversee and coordinate the Parties’ activities under this Agreement. The JSC shall in particular:

(a)    provide a forum for the discussion of the Parties’ activities under this Agreement and facilitate communications between the Parties with respect thereto;

(b)    oversee the technology transfer and assistance to be provided by Kazia to Simcere hereunder and related activities;

(c)    discuss and coordinate the Development of the Compound and Product by each Party (including their respective Affiliates, licensees and sublicensees);

(d)    review and discuss Simcere’s reports of its Development and Commercialization of the Product in the Territory;

(e)    establish joint subcommittees as it deems necessary or advisable for the Development, Manufacture and Commercialization of the Compound and Product;

(f)    discuss the status of GBM AGILE within and outside the Territory and the status of any current or planned clinical trials of the Product in the Field in the Territory; and

(g)    perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or allocated to it by the Parties in writing.

3.2    Limitations of JSC Authority. The JSC shall only have the powers expressly assigned to it in this Article 3 and elsewhere in this Agreement and shall not have the authority to: (a) modify or amend the terms and conditions of this Agreement; (b) waive or determine either Party’s compliance with the terms and conditions of under this Agreement; or (c) decide any issue in a manner that would conflict with the express terms and conditions of this Agreement.

3.3     JSC Membership and Meetings.

(a)    Subject to Section 8.1(b), within thirty (30) days following the Effective Date, each Party shall designate its initial members to serve on the JSC. Each Party may replace its representatives on the JSC on written notice to the other Party. Each Party shall appoint one (1) of its representatives on the JSC to act as a co-chairperson of the JSC. The co-chairpersons shall jointly prepare and circulate agendas and reasonably detailed minutes for each JSC meeting.

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(b)    The JSC shall hold meetings at such times as it elects to do so, but in no event shall such meetings be held less frequently than once every six (6) months.    Meetings of the JSC must be conducted in English and may be held in person, by audio or video teleconference; provided that the Parties shall endeavor to hold one JSC meeting in person each year.    In person JSC meetings shall be held at locations selected alternatively by the Parties. Each Party shall be responsible for all of its own expenses of participating in the JSC. No action taken at any meeting of the JSC shall be effective unless at least one (1) representative from each Party is participating.

(c)    Each Party may from time to time invite a reasonable number of participants, in addition to its representatives, to attend the JSC meetings in a non-voting capacity; provided that such participants shall be bound by confidentiality and non-use obligations consistent with the terms of this Agreement and that each Party shall provide prior written notice to the other Party if it has invited any third party (including any consultant) to attend such a meeting.

3.4    Decision-Making. All decisions of the JSC shall be made by unanimous vote, with each Party’s representatives collectively having one (1) vote, which may be exercised by a Party’s sole attendee at a meeting if both of its representatives do not attend. If after reasonable discussion and good faith consideration of each Party’s view on a matter before the JSC that is within its authority, the representatives of the Parties cannot reach unanimous agreement as to such matter within thirty (30) days after such matter was brought to the JSC for resolution, such disagreement shall be referred to the Chief Executive Officer of Kazia and a Senior Vice President or Vice President level executive of Simcere (the “Executive Officers”) for resolution. If the Executive Officers do not resolve such matter within ten (10) business days after such matter has been referred to them, then: Kazia shall have the final decision making authority with respect to the Development, Manufacture and Commercialization of the Compound and Product outside the Territory, and Simcere shall have the final decision making authority with respect to the Development, Manufacture and Commercialization of the Compound and Product in the Territory; provided however that (a) Kazia may not make a decision that is inconsistent with its obligations to use Commercially Reasonable Efforts to Develop the Product outside the Territory and to complete GBM AGILE (including sites in the Territory), (b) Simcere may not make a decision that is inconsistent with its obligations to use Commercially Reasonable Efforts to Develop and Commercialize the Product in the Territory, (c) each Party shall use Commercially Reasonable Efforts not to make any decision that is reasonably expected to materially and adversely affect the Compound and Product in the Territory; and (d) Simcere may not make any decision regarding a clinical trial of the Product in the Territory that will create material risk to the safety and wellbeing of the patients enrolled in such clinical trial. For the avoidance of doubt, the Parties agree that Kazia will not breach any of its obligations under this Section 3.4 if it ceases to pursue Commercialization of a Product in a jurisdiction outside the Territory.

3.5    Alliance Manager. In addition to the JSC, subject to Section 8.1(b), within thirty (30) days after the Effective Date, each Party shall appoint (and notify the other Party of the identity of) a representative who is fluent in English and has appropriate qualifications (including a general understanding of pharmaceutical development, manufacture and commercialization issues) to act as its alliance manager under this Agreement (the “Alliance Manager”). The Alliance Managers shall serve as the primary contact points between the Parties regarding the activities contemplated by this Agreement. The Alliance Managers shall facilitate the flow of information and otherwise promote communication, coordination and collaboration between the Parties, providing single point communication for seeking consensus both internally within each Party’s respective organization, including facilitating review of external corporate communications, and raising cross-Party and/or cross-functional issues in a timely manner. Each Party may replace its Alliance Manager by written notice to the other Party.

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ARTICLE 4

DEVELOPMENT, MANUFACTURE AND COMMERCIALIZATION

4.1    General. Subject to the terms and conditions of this Agreement and except for GBM AGILE, Simcere shall be solely responsible for the Development and Commercialization of the Product in the Field in the Territory, at Simcere’s own cost and expense.

4.2    Diligence. Subject to Kazia complying with its obligations hereunder with respect to technology transfer and supply of Compound and Product to Simcere, Simcere (either by itself or through its Affiliates and sublicensees) shall use Commercially Reasonable Efforts to Develop and Commercialize at least one Product in the Field in the Territory. Kazia shall use Commercially Reasonable Efforts to Develop the Product outside the Territory and to complete GBM AGILE (including sites in the Territory). Notwithstanding the foregoing, Kazia acknowledges that certain Development activities planned by Simcere overlap with activities otherwise being conducted as part of GBM AGILE, and agrees that, subject to Section 4.4(c)(ii), Simcere shall not be required to conduct such Development activities to the extent such activities overlap with any relevant activities conducted as part of GBM AGILE.

4.3    Technology Transfer. Within thirty (30) days after receiving a notice from Simcere to initiate technology transfer, Kazia shall provide Simcere with all Licensed Know- How that exists on the Effective Date and not previously provided to Simcere, including those items, and on the terms, set forth in Exhibit C. If any additional Licensed Know-How comes into Kazia’s Control during the Term of this Agreement (including any data resulting from GBM AGILE and other Development work of the Compound and Product conducted by Kazia, its Affiliates, licensees and sublicensees), Kazia shall notify Simcere and provide copies thereof to Simcere at the next scheduled JSC meeting (except that data and reports from GBM AGILE shall be provided to Simcere promptly (within five (5) days in any event)). Upon Simcere’s request, Kazia shall also provide Simcere with reasonable technical assistance in connection with the practice of the Licensed IP in the Development of the Compound and Product, including reasonable access to Kazia’s available technical personnel involved in the research and Development of the Compound and Product, at no additional cost to Simcere (but subject to reimbursement of reasonable out-of-pocket cost).

4.4    Development.

(a)    As of the Effective Date, Kazia is conducting a global phase 2 / 3 clinical trial of the Product in glioblastoma as part of the Glioblastoma Adaptive Global Innovative Learning Environment sponsored by the Global Coalition for Adaptive Research (“GCAR”) (such trial of the Product, the “GBM AGILE”). After the Effective Date, Kazia (either by itself or through GCAR or Third Party contractors) shall use Commercially Reasonable Efforts to complete GBM AGILE (including sites in the Territory) at Kazia’s own cost and expense. Kazia shall keep Simcere informed on the progress and results of the GBM AGILE and shall consider in good faith suggestions and comments provided by Simcere regarding the conduct of GBM AGILE in the Territory, including the selection of sites and contractors in the Territory for GBM AGILE. Without limiting the foregoing, where appropriate and when it is able, Kazia shall invite Simcere to participate in any meetings and discussions with GCAR regarding the conduct of GBM AGILE in the Territory. Kazia shall provide Simcere with copies of all GBM AGILE data and reports within five (5) days after receipt from GCAR or clinical sites.

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(b)    Kazia shall notify Simcere if Kazia wishes to conduct a Global Clinical Trial . Kazia shall keep Simcere informed on the planning, progress and results of any Global Clinical Trial and shall consider in good faith any suggestions and comments provided by Simcere regarding the conduct of any Global Clinical Trial in the Territory, including with respect to Simcere’s potential direct involvement, and the selection of sites and contractors, in the Territory for the Global Clinical Trial. Kazia shall also include in contractual arrangements with collaborators with respect to Global Clinical Trials obligations consistent with those in Section 7.5(b) with respect to the publication or disclosure of the results of a Global Clinical Trial.

(c)    Except for GBM AGILE and any Global Clinical Trial, Simcere (either by itself or through its Affiliates and sublicensees), at its own cost and expense, shall be responsible for the Development of the Product in the Field in the Territory, including all pre-clinical studies and all clinical trials of the Product in the Field in the Territory. As of the Effective Date, the Parties expect the efficacy data from GBM AGILE may be used to assist in obtaining the MA of the Product in glioblastoma in the Territory. However, the Parties acknowledge that neither Kazia, nor GCAR, the respective Regulatory Authorities or any other party can provide binding assurances that GBM AGILE will be sufficient to obtain any such MA. If the data from GBM AGILE is not sufficient to support the granting of a MA, Simcere may conduct additional clinical trials of the Product in glioblastoma in order to obtain a MA in the Territory and, subject to Simcere obtaining any necessary approvals or authorizations from all parties involved in a Global Clinical Trial, Simcere may also participate in the Global Clinical Trial through clinical sites in the Territory. For clarity:

(i)    where Simcere does not obtain any necessary approvals or authorizations from all parties involved in a Global Clinical Trial, it will not participate in that Global Clinical Trial; and

(ii)    Simcere shall be responsible for any pharmacokinetic study that is required by a Regulatory Authority in the Territory.

4.5    Regulatory.

(a)    Subject to the remainder of this Section 4.5, Simcere (either by itself or through its Affiliates and sublicensees) shall apply for and maintain, at its own cost and expense, all Regulatory Approvals of the Product in the Field in the Territory. Subject to Section 4.5(b), Simcere shall be responsible for the preparation of all Regulatory Materials and all communications and interactions with Regulatory Authorities with respect to the Product in the Field in the Territory, both prior to and subsequent to Regulatory Approval. Simcere (or its Affiliate or sublicensee) shall file all required regulatory dossiers to obtain (and maintain) Regulatory Approval of the Product in the Field in the Territory and shall be the holder of such Regulatory Approvals in the Territory.

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(b)    Unless otherwise agreed by the Parties in writing and except in exigent circumstance, prior to responding to, or submitting, any material communication to any Regulatory Authority with respect to the Product in the Territory, Simcere shall submit such response or communication to Kazia for review and shall consider in good faith any comments provided by Kazia.

(c)    Notwithstanding Section 4.5(a), Kazia (and its collaborators and contractors, such as GCAR) shall have the right to submit Regulatory Materials, communicate with Regulatory Authorities, and hold Regulatory Approvals with respect to the Product in the Territory solely to the extent required to continue and complete GBM AGILE or any other Global Clinical Trial, including the IND for GBM AGILE or such other Global Clinical Trial.

(d)    For Product that is first approved outside the Territory, Manufactured and supplied by Kazia to Simcere pursuant to Section 4.9(a), and approved in mainland China as an imported drug under an Imported Drug License (“IDL”), if applicable Laws do not allow Simcere to be the holder of the IDL or other Regulatory Materials related to such imported Product, then Kazia shall initially be the holder of the IDL and such Regulatory Materials for the sole benefit of Simcere, until Simcere is permitted by applicable Law to be the holder of the IDL and such Regulatory Materials, at which time Kazia shall use its best endeavors to promptly transfer the IDL and such Regulatory Materials to Simcere. While Kazia is the holder of the IDL and such Regulatory Materials, Kazia shall (i) subject to Section 4.5(b), appoint Simcere as its exclusive regulatory agent to communicate and handle regulatory activities relating to the IDL and such Regulatory Materials with the NMPA and other Regulatory Authorities in mainland China, (ii) appoint Simcere under the IDL as the exclusive distributor of the Product in mainland China, and (iii) not take any action that adversely affects the IDL and such Regulatory Materials in mainland China (without limiting the foregoing, Kazia shall not transfer the ownership of the corresponding Regulatory Approval of the Product outside the Territory to a Third Party, which transfer results in a change to the holder of the IDL in mainland China, unless the Third Party transferee expressly agrees to assume Kazia’s obligations to hold the IDL and such Regulatory Materials in mainland China for the benefit of Simcere as set forth above in this Section 4.5(d).

4.6    Data Sharing. At each JSC meeting, each Party shall keep the other Party reasonably informed on the Development activities conducted by or on behalf of such Party (including its Affiliates, licensees and sublicensees) for the Compound and Product, and, subject to applicable Laws, shall provide the other Party with copies of all data and results, including pre-clinical data, clinical reports and reasonable supporting documentation (such as protocols and data analysis plans) directly relevant to the Development of the Compound or Product, or Commercialization of the Product, in the Field, generated by or on behalf of such Party through the Development of the Compound and Product. Each Party shall have the right to use and reference such data and results provided by the other Party, without additional consideration, for the purpose of obtaining and maintaining Regulatory Approval of the Product in the Field in its territory.

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4.7    Cross Reference. Each Party shall also keep the other Party reasonably informed on the regulatory activities conducted by or on behalf of such Party (including its Affiliates, licensees and sublicensees) for the Product, and shall promptly provide the other Party with copies of all Regulatory Materials directly relevant to the Development of the Compound or Product, or Commercialization of the Product, in the Field submitted to or received from Regulatory Authorities in the Territory. Kazia will also promptly provide Simcere with copies of any Regulatory Materials directly relevant to the Development of the Compound or Product, or Commercialization of the Product, in the Field in the Territory submitted by Kazia to or received from the US FDA, European Medicines Agency (EMA) and Pharmaceuticals and Medical Devices Agency of Japan. Each Party hereby grants to the other Party a right of reference to all Regulatory Materials filed by or on behalf of such Party for the Product, which right of reference the other Party may use for the purpose of seeking, obtaining and maintaining Regulatory Approvals of the Product in the Field in such other Party’s territory.

4.8    Pharmacovigilance. Each Party hereby agrees to comply with its respective obligations under the Exhibit E with respect to the safety and pharmacovigilance procedures for the Parties with respect to the Product, such as safety data sharing and exchange, adverse events reporting and prescription events monitoring and to cause its Affiliates, licensees and sublicensees to comply with such obligations. Promptly following the Effective Date, but in no event later than the date of the first IND approval for any clinical trial of the Product received by Simcere, Kazia and Simcere shall enter into a written pharmacovigilance agreement which will be consistent with the above terms.

4.9    Manufacture and Supply.

(a)    Kazia shall (either by itself or through its Affiliate or Third Party contract manufacturer) Manufacture and supply the Compound and Product requested by Simcere in accordance with Exhibit F for Development and Commercialization use at a price equal to: (i) Manufacturing Cost plus a [***] markup, for Compound and Product supplied for Development use; and (ii) Manufacturing Cost plus a [***] markup, for Compound and Product supplied for Commercialization use. Kazia shall deliver the Compound and Product to Simcere CIF (Incoterms 2020) to Simcere designated port of import in the Territory, provided that Simcere shall reimburse Kazia for the reasonable shipping cost incurred for the delivery of the Product. The Parties must comply with the obligations in Exhibit F with respect to the supply of Compound and Product. The Parties may also negotiate in good faith and seek to agree to a detailed contract manufacturing agreement.

(b)    In addition to purchasing the Compound and Product from Kazia for Development and Commercialization use in the Territory pursuant to Section 4.9(a) above, Simcere shall have the right to Manufacture and have Manufactured the Compound and Product in the Territory, either by itself or through its own contract manufacturer, provided such contract manufacturer is located in the Territory. Upon Simcere’s reasonable request, Kazia shall make available to Simcere all Licensed Know-How directly related to the Manufacture of the Compound and Product in the Territory, and provide Simcere (or its designee) with any reasonable technical assistance to the extent necessary to enable Simcere (or its designee) to Manufacture the Compound and Product in the Territory, at no additional cost to Simcere (but subject to reimbursement of reasonable out-of-pocket cost). In addition, upon Simcere’s reasonable request, Kazia shall introduce Simcere to Kazia’s contract manufacturer for the Compound and Product and shall reasonably assist Simcere to negotiate a technology transfer agreement and, if such contract manufacturer Manufactures the Product in the Territory, a supply agreement directly with such contract manufacturer.

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4.10    Commercialization.

(a)    Subject to Section 4.10(b), Simcere (either by itself or through its Affiliates and sublicensees) shall be responsible for all aspects of the Commercialization of the Product in the Field in the Territory, at Simcere’s own cost and expense, including: (a) developing and executing a commercial launch and pre-launch plan, (b) negotiating with applicable Government Authorities regarding the price and reimbursement status of the Product; (c) marketing and promotion; (d) booking sales and distribution and performance of related services; (e) handling all aspects of order processing, invoicing and collection, inventory and receivables; (f) providing customer support, including handling medical queries, and performing other related functions; and (g) conforming its practices and procedures to applicable Laws relating to the marketing, detailing and promotion of the Product in the Territory.

(b)    Simcere must only market, distribute and sell the Product in the Territory. Simcere (either by itself or through its Affiliates or sublicensees) must not sell any Product to parties where it knows or should know, or where it reasonably suspects, that the party may seek to sell the Product outside of the Territory.

(c)    Kazia must only market, distribute and sell the Product outside the Territory. Kazia (either by itself or through its Affiliates, licensees or sublicensees, other than Simcere and Simcere’s sublicensees) must not sell any Product to parties where it knows or should know, or where it reasonably suspects, that the party may seek to sell the Product in the Territory.

4.11    Reporting. Within sixty (60) days after the end of each calendar year, Simcere shall provide to Kazia a report summarizing its Development and Commercialization of the Product in the Field in the Territory. Together with each report, Simcere shall also provide to Kazia a summary of its plans for the Development and Commercialization of the Product in the next year. The Parties shall review and discuss such report and plan at the JSC meetings.

4.12    Remedial Actions. Each Party will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Product may be subject to any recall, corrective action or other regulatory action with respect to such product taken by virtue of applicable Law (a “Remedial Action”). The Parties will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action. Simcere shall have sole discretion with respect to any matters relating to any Remedial Action for the Product in the Field in the Territory. In the event that Simcere determines that any Remedial Action with respect to the Product should be commenced in the Field in the Territory, or if Remedial Action is required by any Regulatory Authority having jurisdiction over the matter in the Territory, Simcere will control and coordinate all efforts necessary to conduct such Remedial Action in the Field in the Territory and shall be responsible for all cost and expense of such Remedial Action (unless the Remedial Action is due to Manufacturing defect in the Compound or Product supplied by Kazia, in which case Kazia shall reimburse Simcere for the cost and expense of such Remedial Action). Notwithstanding the foregoing, to the extent possible, Simcere will consult with Kazia regarding any such Remedial Action plan and provide to Kazia a copy of any communication from, or which Simcere proposes to provide to, a Regulatory Authority relating to a Remedial Action. Kazia may review and provide comments on any proposed communications to a Regulatory Authority by Simcere, in which case Simcere must consider such comments in good faith and acting reasonably.

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4.13    Regulatory/Quality Audit. Upon reasonable advance notice, Kazia shall have the right to audit the regulatory, safety, quality and compliance systems, procedures and practices of Simcere relating to the Development and Manufacture of the Compound and the Product in the Field in the Territory. Kazia may not conduct such audit more than once each calendar year unless (a) a prior audit in that calendar year discovers material non-compliance by Simcere with its obligations under this Agreement, or (b) a Regulatory Authority conducts an audit of Kazia or its Affiliates for the purpose of verifying any matter related to the Compound or Product. Such audit shall take place during Simcere’s normal business hours and shall not interfere with Simcere’s normal operations, and Simcere shall have the right to limit access to and/or redact information relating to other products. After the completion of the audit, Kazia shall promptly provide Simcere with a written audit report. If the audit reveals any potential or actual non-compliance by Simcere or its Affiliates or areas of improvement, the Parties shall discuss such findings and Simcere shall take corrective or improvement actions as mutually agreed by the Parties.

ARTICLE 5

Payments

5.1    Upfront Payment. Simcere shall pay to Kazia a one-time, non-refundable upfront payment of seven million Dollars ($7,000,000) within forty five (45) days after receipt of the invoice issued by Kazia after the Effective Date.

5.2    Equity Investment. Prior to or concurrently with the execution of this Agreement, the Parties (or their designated Affiliates) shall enter into a share subscription agreement, pursuant to which Kazia shall issue to Simcere, and Simcere shall subscribe from Kazia, four million Dollars ($4,000,000) of newly issued American Depository Shares of Kazia, each representing 10 ordinary shares of Kazia (the “ADSs”), at a purchase price per ADS equal to one hundred twenty percent (120%) [***].

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5.3 Development Milestone Payments.

(a)    Milestone Events. Subject to the remainder of this Section 5.3, Simcere shall pay to Kazia the following one-time, non-refundable development milestone payments set forth in the table below upon the first achievement of the corresponding milestone event:

Development Milestone Event	Milestone Payment in Dollars
[***]	[***]
[***]	[***]
[***]
[***]	[***]
[***]	[***]
[***]	[***]
[***]	[***]
[***]	[***]
[***]	[***]
[***]	[***]
[***]	[***]

(b)    Milestone Conditions.

(i)    Each development milestone payment set forth above shall be due and payable only once, regardless of how many times such milestone event is achieved and/or the number of Products that achieve such milestone event. For milestone #3 (Obtainment of a MA for glioblastoma from NMPA), the milestone payments in either clause (a) or clause (b), but not both, may be due and payable. For clarity, the aggregate milestone payments under this Section 5.3 shall not exceed [***]

(ii)    “Initiation” of a human clinical trial means the first dosing of the first human subject enrolled in such clinical trial.

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(iii)    “Successful completion of GBM AGILE” means that the results of such clinical trial meet all study endpoints specified in Exhibit D attached hereto.

(iv)    “additional major Indication” means (A) brain metastases from a primary tumour of the breast, lung, skin, colon, or kidney, or combination thereof, or (B) newly-diagnosed unmethylated glioblastoma, newly-diagnosed methylated glioblastoma, or recurrent glioblastoma; provided that in both (A) and (B) that at least fifty per cent (50%) of the patients covered by such new approval were not previously approved to receive treatment with the Product, and that the approval was the subject of a distinct MA filing to the applicable regulatory agency.

(v)    “additional non-major Indication” means primary brain tumours other than glioblastoma, and brain metastases from primary tumours other than those listed in Section 5.3(b)(iv).

(vi)    approvals in Indications which do not meet the definition of “additional major Indication” or “additional non-major Indication” will be discussed between the Parties in good faith to determine whether such approvals should be considered major or non-major Indications for the purposes of this Agreement.

For clarity, an additional major Indication or an additional non-major Indication shall require a separate MA to any other MA involving the Compound already in existence.

(c)    Notice and Payment. For milestone #2 ([***]), Kazia shall notify Simcere in writing within thirty (30) days after the first achievement of such milestone and shall provide Simcere with reasonable supporting documents for the achievement of such milestone [***]. For all other milestones set forth above, Simcere shall notify Kazia in writing within thirty (30) days after the first achievement of such milestone. Simcere shall pay to Kazia the corresponding milestone payment within forty five (45) days after the receipt of the invoice issued by Kazia after the achievement of such milestone. For the avoidance of doubt, payment in accordance with these terms must be made even where notice of milestone satisfaction is not provided in accordance with this clause 5.3(c).

5.4 Sales Milestone Payments.

(a)    Milestone Events. Subject to the remainder of this Section 5.4, Simcere shall pay to Kazia the following one-time, non-refundable sales milestone payments set forth in the table below when the aggregated annual Net Sales of the Product sold in the Territory in a calendar year first reach the corresponding threshold value indicated below.

First time aggregate annual Net Sales (in Dollars) of the Product in the Territory exceed:	Milestone Payment in Dollars
[***]	[***]
[***]	[***]
[***]	[***]

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First time aggregate annual Net Sales (in Dollars) of the Product in the Territory exceed:	Milestone Payment in Dollars
[***]	[***]
[***]	[***]
[***]	[***]
[***]	[***]

(b)    Milestone Conditions.    Each sales milestone payment set forth above shall be due and payable only once, regardless of how many times such milestone event is achieved. The Net Sales of Product sold in a region in the Territory after the expiration of the Royalty Term in such region shall not be included in the calculation of annual Net Sales to determine whether any Net Sales threshold has been achieved. The aggregate milestone payments under this Section 5.4 shall not exceed [***].

(c)    Notice and Payment. As part of the Royalty Report in Section 5.5(e), Simcere shall provide written notice to Kazia if the aggregated annual Net Sales of the Product in the Territory first reach any threshold value set forth in Section 5.4(a) above during the time period to which such report pertains. Simcere shall pay to Kazia the corresponding milestone payments within forty five (45) days after the receipt of the invoice issued by Kazia after the achievement of such milestone. For the avoidance of doubt, payment in accordance with these terms must be made even where notice of milestone satisfaction is not provided in accordance with this clause 5.4(c).

5.5 Royalty Payments.

(a)    Royalty Rate. Subject to the remainder of this Section 5.5, Simcere shall make quarterly non-refundable royalty payments to Kazia on the Net Sales of the Product sold in the Territory, as calculated by multiplying the applicable royalty rate set forth in the table below by the corresponding amount of incremental, aggregated annual Net Sales of the Product sold in the Territory during the applicable calendar year.

For that portion of annual Net Sales (in Dollars) of the Product in the Territory	Royalty Rate
[***]	[***]
[***]	[***]
[***]	[***]

(b)    Royalty Term. Simcere’s obligation to pay royalties pursuant to this Section 5.5 shall expire, on a Product-by-Product and region-by-region basis, [***] after the First Commercial Sale of such Product in such region (the “Royalty Term”).

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(c)    Royalty Conditions. The royalties under this Section 5.5 shall be subject to the following conditions:

(i)    only one (1) royalty shall be due with respect to each unit of Product, without regard to whether there is more than one Valid Claim or Licensed Patent claiming such Product;

(ii)    no royalties shall be due upon the sale or other transfer of the Product among Simcere, its Affiliates and sublicensees, but in such cases the royalty shall be due and calculated upon Simcere’s, its Affiliate’s or sublicensee’s Net Sales of Product to the first Third Party (other than sublicensee);

(iii)    no royalties shall accrue on the disposition of Product in reasonable quantities by Simcere, its Affiliates or sublicensees for use in clinical trials and other development work, as part of an expanded access program, as free samples, or as donations to non-profit institutions or government agencies for non-commercial purposes, provided that in each case no revenue is generated by Simcere, its Affiliates or sublicensees; and

(iv)    the Net Sales of Product sold in a region after the expiration of the Royalty Term in such region shall not be included in the calculation of annual Net Sales to determine the applicable royalty tiers.

(d)    Royalty Reductions.

(i)    If a Product is sold in a region in the Territory during the applicable Royalty Term at a time when there is no Valid Claim in the Licensed Patents that claims the composition of matter of the Compound contained in such Product in such region, then the royalty rate applicable to the Net Sales of such Product in such region during such time shall be reduced by [***] of the royalty rate otherwise applicable to all Net Sales for such Product in the Territory under Section 5.5(a).

(ii)    If Simcere, its Affiliate or sublicensee, upon the advice of competent counsel properly qualified to provide the advice, requires and obtains a license under a Third Party patent where such composition of matter patent covers the Compound included in a Product, then Simcere shall have the right to deduct, from the royalty payment that would otherwise have been due pursuant to Section 5.5(a), an amount equal to [***] of the amount paid by Simcere or its Affiliate or sublicensee to such Third Party pursuant to such license during the same period; provided, however, that in no event shall the amount otherwise payable under Section 5.5(a) to Kazia with respect to such Product be reduced more than [***] of what would otherwise be due on the sale of such Product.

(e)    Report. Within forty five (45) days after the end of each calendar quarter, commencing with the First Commercial Sale of the Product in the Territory, Simcere shall provide Kazia with a royalty report that contains the following information for the applicable calendar quarter and calendar year (to date if not yet a full calendar year), on a Product-by-Product and region-by-region basis: (i) the number of units of each Product sold; (ii) the amount of gross sales of the Product, (iii) a calculation of Net Sales of the Product, (iv) a calculation of the royalty payment due on such Net Sales, including the application of any reduction made in accordance with Section 5.5(d), (v) the exchange rate for such region, and (vi) the aggregate annual Net Sales and whether any sales milestone has been achieved (“Royalty Report”).

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(f)    Payment. Within ten (10) business days after the date on which the Royalty Report is given to Kazia (“Review Period”), Kazia may, acting reasonably and in good faith, make an enquiry to Simcere about any aspect of the Royalty Report (“Royalty Query”).

(i)    If at the end of the Review Period, Kazia has not made any Royalty Query, all amounts set out in the Royalty Report will be taken to be final and binding on the Parties and Simcere must, within forty five (45) days after the issue of a valid invoice by Kazia, pay to Kazia an amount equal to the royalty amount set out in Section 5.5(a), being the amount included in the Royalty Report in accordance with Section 5.5(e)(iv), in respect of Net Sales made during the period of the relevant Royalty Report.

(ii)    If a Royalty Query is made within the Review Period, then Simcere must properly respond to such Royalty Query, including (if applicable) providing evidence to support the amounts set out in the Royalty Report. If the Royalty Query has not been resolved within forty-five (45) business days after the Royalty Query is made, Kazia may exercise its audit right in accordance with Section 5.11.

(iii)    Where a Royalty Query is: (a) resolved or otherwise agreed by the Parties; or (b) determined by an Auditor in accordance with Section 5.11, Kazia must issue an invoice to Simcere for the agreed or determined royalty amount and Simcere must pay that amount within forty-five (45) days after issue of the invoice.

5.6    Kazia’s Third Parties Payment Obligations. Kazia shall be solely responsible for the payment of royalty, milestone and other payments due to Third Parties under any agreements between Kazia (or its Affiliates) and Third Parties (including the Genentech Agreement) on account of Simcere’s, its Affiliates’ and sublicensees’ Development, Manufacture and Commercialization of the Product in the Field in the Territory.

5.7    Currency; Exchange Rate. All payments due from Simcere to Kazia under this Agreement shall be made by Simcere in Dollars by bank wire transfer in immediately available funds to a bank account designated by Kazia in writing. The rate of exchange to be used in computing the amount of currency equivalent in Dollars shall be made at the average of the closing exchange rates reported by Bank of China for the first, middle and last business days of the applicable reporting period for the payment due.

5.8    Blocked Currency. If the conversion of a local currency in the Territory into Dollars or transfer of funds out of a region in the Territory becomes materially restricted, forbidden or substantially delayed due to applicable Laws, then Simcere must immediately notify Kazia and amounts accrued in such region may be paid by Simcere in local currency into an account in a local bank designated by Kazia, or such legal payment method as otherwise directed by Kazia. If the conversion of local currency into Dollars or transfer of funds out of a region in the Territory is materially restricted, forbidden or substantially delayed due to applicable Laws for more than eight (8) months and while it continues, Kazia may, at its sole discretion, terminate this Agreement with immediate effect by giving written notice to Simcere.

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5.9    Late Payments. If Kazia does not receive payment of any sum due to it on or before the due date, interest shall thereafter accrue on the sum due from the due date until the date of payment at a per-annum rate of prime (as reported Bank of China) plus two (2) percentage points or the maximum rate allowable by applicable Law, whichever is less. Notwithstanding the foregoing, the interest set forth in this Section 5.9 shall not apply if the payment is delayed due to government restriction on currency conversion or transfer of funds out of a region in the Territory.

5.10    Taxes.

(a)    Taxes on Income. Each Party shall be solely responsible for the payment of all taxes imposed on its share of income arising directly or indirectly from the activities of the Parties under this Agreement. For clarity, all payment amounts in this Article 5 are on a pre-tax basis.

(b)    Tax Cooperation. The Parties agree to cooperate with one another and use reasonable efforts to avoid or reduce tax withholding or similar obligations in respect of royalties, milestone payments, and other payments made under this Agreement. To the extent Simcere is required to deduct and withhold taxes on any payment to Kazia, Simcere shall deduct those taxes from the remittable payment, pay the taxes to the proper tax authority in a timely manner, and promptly send proof of payment to Kazia. Kazia shall provide Simcere any tax forms that may be reasonably necessary in order for Simcere to not withhold tax or to withhold tax at a reduced rate under an applicable bilateral income tax treaty. Kazia shall use reasonable efforts to provide any such tax forms to Simcere in advance of the due date. At the request and expense of Kazia, Simcere shall provide reasonable assistance to enable the recovery, to the extent permitted by Law, of withholding taxes or similar obligations resulting from payments made under this Agreement.

5.11    Records and Audit.

(a)    Simcere shall maintain complete and accurate records of its, and its Affiliates’ and sublicensees’ sales, transfers and other dispositions of the Product necessary for the calculation of payment due to Kazia under this Agreement. Simcere shall maintain such records for the longer of (i) the period of time required under any applicable Law, and (ii) three (3) years following the end of the calendar year to which of such records pertain.

(b)    Kazia may, at any time during the Term and for a period of three (3) years following the expiration or termination of this Agreement, through an independent certified public accountant nominated by Kazia and acceptable to Simcere (the “Auditor”), undertake an audit of Simcere’s records related to the sale and disposition of the Product, for the three (3) year period before such notice for the purpose of verifying all payments made under this Agreement (“Audit”). Simcere shall, no later than thirty (30) days of Kazia’s notice of an Audit, permit the Auditor to have access to Simcere’s records related to the sale and disposition of the Product, for the three (3) year period before such notice and during Simcere’s normal business hours for the purpose of undertaking the Audit. The Auditor shall be required to enter into a confidentiality agreement reasonably acceptable to Simcere to protect the confidentiality of Simcere’s records before the Audit starts. Kazia may not conduct an Audit more than once each calendar year unless: (i) a prior Audit in that calendar year determined an error by Simcere resulting in underpayment to Kazia of greater than five percent (5%) for the audited period; or (ii) Kazia is required to verify payments made under this Agreement as a result of Genentech seeking to conduct an audit in accordance with the terms of the Genentech Agreement.

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(c)    Kazia shall bear the cost of an Audit under this Section 5.11, unless the Auditor’s audit report reveals an uncontested underpayment by Simcere of more than five percent (5%) of the amount actually due for the time period being audited or a material breach by Simcere of its obligations under this Agreement, in which case Simcere shall reimburse Kazia for the costs of the relevant Audit.

(d)    Upon completion of the Audit, the Auditor shall deliver its audit report to both Parties. Where the Auditor’s audit report shows that payments made by Simcere are deficient, Simcere shall pay to Kazia the uncontested underpayment within sixty (60) days after the date of the Auditor’s audit report, plus interest (as set forth in Section 5.9) from the original due date. If the Auditor’s audit report reveals an uncontested overpayment by Simcere, then Simcere may take a credit for such uncontested overpayment against any future payments due to Kazia (if there will be no future payment due, then Kazia shall promptly refund such amount to Simcere). Contested amounts are subject to dispute resolution by an Expert under Exhibit H. The full amount of any underpayment by Simcere determined to be payable to Kazia pursuant to this Section 5.11(d) shall accrue interest in accordance with Section 5.9.

(e)    Where the Auditor’s audit report shows that Simcere is in breach of its obligations under this Agreement, the Parties will promptly meet to agree a remediation plan such that any breach by Simcere may be remedied. In such case, Kazia must provide to Simcere reasonable evidence of the relevant findings set out in the Auditor’s audit report.

ARTICLE 6

INTELLECTUAL PROPERTY RIGHTS

6.1    Inventions.

(a)    Each Party shall solely own all Inventions invented or developed solely by or on behalf of such Party, including its and its Affiliate’s employees, contractors and/or agents. The Parties shall jointly own all Inventions invented or developed jointly by both Parties. Except to the extent restricted by the licenses and other rights granted to the other Party under this Agreement or any other agreement between the Parties, with respect to jointly developed Inventions each Party, as joint owners, shall be entitled to practice, license, assign and otherwise exploit its interest in the jointly owned Inventions without the duty of accounting or seeking consent from the other Party.

(b)    Each Party shall promptly disclose to the other Party all Inventions invented or developed by or on behalf of such Party under this Agreement, including any invention disclosures, or other similar documents, submitted to it by its employees, agents or independent contractors describing such Inventions, and shall promptly respond to reasonable request from the other Party for additional information relating to such Inventions.

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(c)    Simcere hereby grants to Kazia a non-exclusive and royalty free license under any Inventions invented or developed solely by Simcere to (i) research, Develop, make, have made, use, sell, offer for sale, have sold, import and otherwise Commercialize the Compound and Product in the Field outside the Territory, (ii) conduct non-clinical research, GBM AGILE and other Global Clinical Trials in each case for the Compound and the Product in the Field in the Territory, and (iii) Manufacture the Compound and Product in the Territory for export out of the Territory, which license shall be sublicenseable by Kazia provided that the sublicensee grants to Kazia a sublicensable license under any invention invented or developed by the sublicensee through the Development, Manufacture or Commercialization of the Product so that Kazia can include such invention in the Licensed IP and the license granted to Simcere hereunder.

6.2    Patent Prosecution.

(a)    As between the Parties, Kazia shall have the first right to file, prosecute and maintain all Licensed Patents throughout the world, at Kazia’s own cost and expense.

(b)    Kazia shall consult with Simcere and keep Simcere reasonably informed of the status of the Licensed Patents in the Territory and also in the US and EU, and shall promptly provide Simcere with all material correspondence received from any patent authority in the Territory in connection therewith. In addition, Kazia shall promptly provide Simcere with drafts of all proposed material filings and correspondence to any patent authority in the Territory with respect to the Licensed Patents for Simcere’s review and comment prior to the submission of such proposed filings and correspondences. Kazia shall consider in good faith Simcere’s comments prior to submitting such filing and correspondences.

(c)    Kazia shall notify Simcere of any decision to cease prosecution or maintenance of any Licensed Patents in the Territory. Kazia shall provide such notice at least thirty (30) days prior to any filing or payment due date, or any other due date that requires action, in connection with such Licensed Patent. In such event, upon Simcere’s request, Kazia shall transfer the prosecution and maintenance of such Patents in the Territory to Simcere, and Simcere shall have the right to continue prosecution or maintenance of such Patents in the Territory at Simcere’s own expense.

(d)    Each Party shall provide the other Party all reasonable assistance and cooperation in the patent prosecution efforts under this Section 6.2, including providing any necessary powers of attorney and executing any other required documents or instruments for such prosecution.

6.3    Patent Enforcement.

(a)    [***].

(b)    [***]

(c)    [***]

(d)    [***]

(e)    [***]

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(f)    [***][***]

(g)    [***]

6.4    [***]

(a)    [***]

(b)    [***]

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6.5    [***]

6.6    Bankruptcy Protection. All licenses granted by a Party to the other Party under this Agreement are and shall otherwise be deemed to be, for purposes of Section 365(n) of Title 11, United States Code or foreign equivalent Laws (the “Bankruptcy Code”), licenses of rights to “intellectual property” as defined in Section 101 of the Bankruptcy Code. To the extent permitted by Law, as the licensee, the non-bankruptcy Party shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code. Upon the bankruptcy of a Party, the non-bankruptcy Party, as the licensee, shall, to the extent permitted by Law, further be entitled to a complete duplicate of, or complete access to, any such intellectual property, and such, if not already in its possession, shall be promptly delivered to the non-bankruptcy Party, unless the bankruptcy Party elects to continue, and continues, to perform all of its obligations under this Agreement.

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6.7    Trademarks.

(a)    Kazia hereby grants to Simcere a non-exclusive license (with the right to sublicense) for the Term to the trademarks and trade names Controlled by Kazia and used by Kazia in connection with the Product (“Licensed Trademarks”) solely in order for Simcere to Commercialize the Product in the Field in the Territory. During the Term, Kazia shall not grant any licence under the Licensed Trademarks to any Third Party in order for the Third Party to Commercialize the Product in the Territory. Kazia shall own all rights in the Licensed Trademarks, and all goodwill in the Licensed Trademarks shall accrue to Kazia. Kazia shall register, maintain and enforce, at its own cost, expense and discretion, the Licensed Trademarks in the Territory as Kazia determines reasonably necessary.

(b)    In addition to (or in lieu of ) the Licensed Trademarks, Simcere shall have the right to brand the Product for use in connection with its Commercialization in the Territory using Simcere related trademarks and any other trademarks and trade names (including Chinese character trademarks and trade names) Simcere determines appropriate for the Products, which may vary by region or within a region in the Territory (“Product Marks”). Simcere shall own all rights in the Product Marks, and all goodwill in the Product Marks shall accrue to Simcere. Simcere shall register, maintain and enforce, at its own cost and expense, the Product Marks in the Territory as Simcere determines reasonably necessary.

6.8    License Registration. If required or permitted by applicable Laws, Simcere may register the license granted by Kazia to Simcere hereunder with Government Authorities in the Territory, including the China National Intellectual Property Administration, by submitting this Agreement (or a simplified and/or Chinese language version of this Agreement) and other required documents to the applicable Government Authorities. Upon Simcere’s reasonable request, Kazia shall execute such documents and take such further action reasonably required by Simcere in connection with such registration.

ARTICLE 7

CONFIDENTIALITY

7.1    Confidentiality Obligations. Except to the extent expressly authorized by this Agreement or otherwise agreed in writing by the Parties, each Party agrees that, during the Term of this Agreement and ten (10) years thereafter, it shall keep confidential and shall not publish or otherwise disclose and shall not use for any purpose other than as provided for in this Agreement (which includes the exercise of any rights or the performance of any obligations hereunder) any Confidential Information of the other Party.

7.2    Exceptions. The obligations set forth in Section 7.1 shall not apply to any information that the receiving Party can demonstrate that such information:

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(a)    is known by the receiving Party at the time of its receipt without an obligation of confidentiality, and not through a prior disclosure by the disclosing Party, as documented by the receiving Party’s business records;

(b)    is in the public domain before its receipt from the disclosing Party, or thereafter enters the public domain other than through the receiving Party’s breach of the confidentiality obligations set forth herein;

(c)    is subsequently disclosed to the receiving Party by a Third Party who may lawfully do so and is not under an obligation of confidentiality to the disclosing Party; or

(d)    is developed by the receiving Party independently and without use of, or reference to, any Confidential Information of the disclosing Party, as documented by the Receiving Party’s business records.

Any combination of features or disclosures shall not be deemed to fall within the foregoing exclusions merely because individual features are published or available to the general public or in the rightful possession of the receiving Party unless the combination itself and principle of operation are published or available to the general public or in the rightful possession of the receiving Party.

7.3    Authorized Disclosures. Notwithstanding the obligations set forth in Sections 7.1 and 7.6, a Party may disclose the other Party’s Confidential Information to any Affiliate, actual or bona fide potential sublicensee, subcontractor, agent, officer, investor, professional adviser, banker, auditor, clinician or other consultant (each a “Recipient”) only if the disclosure is made strictly on a “need to know basis” and, prior to the disclosure, the Party (i) notifies the Recipient of the confidential nature of the Confidential Information to be disclosed, and (ii) the Recipient enters into a written agreement of confidentiality with the Party, or the Recipient is bound by professional or ethics obligation regarding confidentiality, which in either case is at least as restrictive as the obligations in this Article 7 (provided that the duration of such confidentiality obligation can be shorter (but no less than five (5) years) for a Recipient that is a banker, investor, or other financial partners). Without limiting the foregoing, a Party may disclose Confidential Information to the extent:

(a)    such disclosure is necessary: (i) for the filing, prosecution and enforcement of Patents as contemplated by this Agreement; (ii) in connection with regulatory filings for Product; (iii) for the prosecuting or defending litigation as contemplated by this Agreement; or (iv) in connection with the exercise of a Party’s rights or the performance of its obligations hereunder;

(b)    such disclosure is required by applicable Laws, judicial or administrative process, provided that in such event, to the extent possible, such Party shall promptly inform the other Party of such required disclosure and provide the other Party an opportunity to challenge or limit the disclosure obligations. Confidential Information that is disclosed pursuant to this Section 7.3(b) shall remain otherwise subject to the confidentiality and non-use provisions of this Article 7, and the Party disclosing Confidential Information pursuant to Law or court order shall take all steps reasonably necessary, including seeking of confidential treatment or a protective order to ensure the continued confidential treatment of such Confidential Information.

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7.4    Breach by Recipient. A Party which discloses the other Party’s Confidential Information to a Recipient, is liable for breach of this Article 7 by a Recipient as if the Recipient was a Receiving Party in relation to the Confidential Information disclosed to the Recipient.

7.5    Scientific Publication.

(a)    Except to the extent required by applicable Laws, Simcere shall not publish any peer-reviewed manuscripts, or give other forms of public disclosure such as abstracts and presentations, relating to the Compound or Product other than in the Territory and with Kazia’s approval. Simcere shall provide Kazia with a draft of any proposed publication relating to the Compound or Product at least thirty (30) days prior to its intended submission for publication. Upon Kazia’s request, Simcere shall remove any and all of Kazia’s Confidential Information from the proposed publication, and shall delay the submission for a period up to ninety (90) days to allow time for the preparation and filing of a patent application directed to any Inventions disclosed in such publication. Simcere shall also provide Kazia a copy of the manuscript at the time of the submission.

(b)    Kazia shall keep Simcere informed on any scientific publication relating to the Compound and Product and shall provide Simcere with a draft of any such proposed publication for review at least thirty (30) days prior to its intended submission for publication. Kazia shall consider Simcere’s comments in good faith and shall not include any Confidential Information of Simcere in its publication, but Simcere shall not have the right to approve Kazia’s publication.

7.6    Publicity.

(a)    The Parties have agreed on language of press release for each Party announcing this Agreement, which is attached hereto as Exhibit G, to be issued by the Parties promptly after the Effective Date. Subject to the rest of this Section 7.6 and Section 7.3, no disclosure of the terms of this Agreement may be made by either Party, and neither Party shall use the name, trademark, trade name or logo of the other Party, its Affiliates or their respective employee(s) in any publicity, promotion, news release or disclosure relating to this Agreement or its subject matter, without the prior express written permission of the other Party, except as may be required by Law. Following the initial joint press release announcing this Agreement, either Party shall be free to disclose or publicize, without the other Party’s prior written consent, the existence of this Agreement, the identity of the other Party, and those terms of the Agreement which have already been publicly disclosed in accordance herewith.

(b)    A Party may disclose this Agreement and its terms in securities filings with the Securities Exchange Commission (or equivalent agency) or the stock exchange on which such Party’s or its Affiliate’s stock is publicly traded (the “Securities Regulators”) to the extent required by Law or the rules of the Securities Regulator after complying with the procedure set forth in this Section 7.6. In such event, the Party seeking such disclosure will, where possible, prepare a draft confidential treatment request and proposed redacted version of this Agreement to request confidential treatment for this Agreement, and the other Party agrees to promptly (and in any event, no less than seven (7) days after receipt of such confidential treatment request and proposed redactions) give its input in a reasonable manner in order to allow the Party seeking disclosure to file its request within the time lines proscribed by applicable Laws. The Party seeking such disclosure shall exercise Commercially Reasonable Efforts to obtain confidential treatment of this Agreement as represented by the redacted version reviewed by the other Party or to the extent otherwise reasonably possible.

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(c)    Each Party acknowledges that the other Party may be legally required to make public disclosures (including in filings with Securities Regulators) of certain material developments or material information generated under this Agreement and agrees that each Party may make such disclosures as required by Law or the rules of the Securities Regulator, provided that the Party seeking such disclosure, where possible, first provides the other Party a copy of the proposed disclosure, and provided further that (except to the extent that the Party seeking disclosure is required to disclose such information to comply with Law or the rules of the Securities Regulator and where possible) if the other Party demonstrates to the reasonable satisfaction of the Party seeking disclosure, within three (3) business days of such Party’s providing the copy, that the public disclosure of previously undisclosed information may adversely affect the Development and/or Commercialization of the Product, the Party seeking disclosure will remove from the disclosure such specific previously undisclosed information as the other Party shall reasonably request to be removed.

7.7    Prior CDA. This Agreement supersedes the Confidentiality Agreement between the Parties dated 21 April 2020 (the “Prior CDA”) with respect to information disclosed thereunder. All information exchanged between the Parties under the Prior CDA shall be deemed Confidential Information of the disclosing Party and shall be subject to the terms of this Article 7.

7.8    Equitable Relief. Each Party acknowledges that a breach of this Article 7 cannot reasonably or adequately be compensated in damages in an action at law and that such a breach shall cause the other Party irreparable injury and damage. By reason thereof, each Party agrees that the other Party shall be entitled, in addition to any other remedies it may have under this Agreement or otherwise, to preliminary and permanent injunctive and other equitable relief to prevent or curtail any breach of the obligations relating to Confidential Information set forth herein.

ARTICLE 8

TERM AND TERMINATION

8.1    Term.

(a)    Subject to clause 8.1(b), the term of this Agreement (“Term”) shall commence upon the Effective Date and, unless terminated by either Party pursuant to Section 8.2, shall continue in full force and effect, on Product-by-Product and region-by-region basis, until the expiration of the Royalty Term for such Product in such region. After the expiration (but not early termination) of the Term for a particular Product in a particular region, the licenses granted by Kazia to Simcere hereunder shall continue and shall become fully paid, royalty free, perpetual and irrevocable with respect to such Product in such region.

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(b)    The formation of a binding contract by this Agreement, other than this Section 8.1 and Article 1 (Definitions), Section 5.2 (Equity Investment), Article 7 (Confidentiality) and Article 11 (General Provisions) is subject to the fulfilment of the obligation in Section 5.2 to enter into the Share Subscription Agreement. Where that obligation is not fulfilled within forty five (45) days of the Effective Date, Kazia will be entitled to terminate this Agreement (to the limited extent it applies) upon written notice to Simcere with immediate effect.

8.2    Termination.

(a)    Termination where Development or Commercialization deemed unviable. At any time during the Term, if Simcere considers that the Development of the Compound or Product, or Commercialization of the Product, in the Field in the Territory is unviable, Simcere may request to terminate this Agreement (either in whole or on a Product-by-Product and region-by-region basis) by providing written notice to Kazia. The Parties must discuss any such notice in good faith and following reasonable efforts to remediate, either Party may terminate this Agreement (either in whole or on a Product-by-Product and region-by-region basis as requested by Simcere in its notice) on the basis of such notice by providing written notice of termination to the other Party, which notice includes an effective date of termination at least thirty (30) days after the date of the notice.

(b)    Termination for Material Breach. If either Party believes that the other is in breach of its material obligations hereunder, then the non-breaching Party may deliver notice of such breach to the other Party. The allegedly breaching Party shall have sixty (60) days from such notice to dispute or cure such breach. If the Party receiving notice of breach fails to cure, or fails to dispute, that breach within the cure period set forth above, then the Party originally delivering the notice of breach may terminate this Agreement effective on written notice of termination to the other Party. If the allegedly breaching Party disputes the existence, materiality or cure of the alleged breach, the other Party shall not have the right to terminate this Agreement until it has been determined pursuant to Section 11.6 that the alleged breaching Party is in material breach of this Agreement, and such breaching Party further fails to cure such breach within thirty (30) days after the conclusion of that dispute resolution procedure.

(c)    Termination by Kazia. Kazia may immediately terminate this Agreement by providing written notice of termination to Simcere if Simcere (i) materially breaches any of its representations or warranties under Article 9, (ii) materially breaches any of its obligations under Article 5, or (iii) fails to use Commercially Reasonable Efforts to satisfy each milestone event under Article 5 or to Develop and Commercialize the Licensed IP; and, in each case, fails to remedy the breach in (i), (ii) or (iii) within sixty (60) days of being given notice to do so by Kazia.

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8.3    Effect of Termination.

(a)    Termination of Simcere’s License. Upon the early termination of this Agreement for any reason, all rights and licenses granted by Kazia to Simcere under this Agreement shall terminate.

(b)    Specific Consequences.

(i)    Reversion License. Upon early termination of this Agreement for any reason, Simcere shall grant to Kazia an exclusive license under the data, results and other Inventions generated by Simcere through the Development, Manufacture and Commercialization of the Compound and Product to research, Develop, make, have made, use, sell, offer for sale, have sold, import and otherwise Commercialize the Compound and Product in the Field, which license shall not be subject to a royalty payment unless the Agreement is terminated by Simcere for Kazia’s uncured material breach, in which case any such royalty payment to Simcere will be negotiated and agreed by the Parties and shall become effective only upon such termination and the Parties’ agreement on such royalty payment. Upon expiration of this Agreement, Simcere shall grant to Kazia a non-exclusive license under the data, results and other Inventions generated by Simcere through the Development, Manufacture and Commercialization of the Compound and Product to research, Develop, make, have made, use, sell, offer for sale, have sold, import and otherwise Commercialize the Compound and Product in the Field, which license shall not be subject to a royalty payment.

(ii)    Payment. Upon expiration or early termination of this Agreement for any reason, Simcere must pay to Kazia in accordance with the terms of this Agreement any unpaid invoices submitted before termination or any invoices submitted by Kazia after termination in relation to royalties or other payments accrued before termination and due in accordance with Article 5.

(iii)    Cessation of activities. Upon early termination of this Agreement for any reason, Simcere must cease conducting any activities with respect to Development or Manufacture of any Compound or Products and Commercialization of Products. Simcere must also discontinue making any representations regarding its status as a licensee of Kazia for any Products.

(iv)    Reversion of prosecution and maintenance of Patents. Upon expiration or early termination of this Agreement for any reason, Simcere must transfer the prosecution and maintenance of such Licensed Patents in the Territory to Kazia it, at any time during the Term, became responsible for in accordance with Section 6.2(c).

(v)    Regulatory Materials. Upon early termination of this Agreement for any reason, Simcere shall, to the extent permitted by applicable Laws, transfer and assign to Kazia all of Simcere’s and its Affiliates’ right, title and interest in and to any and all Regulatory Approvals and other Regulatory Materials for the Product.

(vi)    Data. Upon expiration or early termination of this Agreement for any reason, subject to applicable Laws, Simcere shall provide Kazia with copies of any data and results generated from clinical trials and other studies of the Product which were not previously provided to Kazia by Simcere.

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(vii)    Product Inventory. Upon early termination of this Agreement for any reason, Kazia shall have the right to purchase from Simcere all or part of the inventory of the Product held by Simcere as of the effective date of termination at a price equal to the cost paid by Simcere for such inventory (or Simcere’s fully burdened manufacturing cost if such inventory is manufactured by Simcere itself). Kazia shall notify Simcere whether Kazia elects to exercise such right within thirty (30) days after the effective date of termination. If Kazia does not exercise such right, then Simcere shall have the right to continue to sell any remaining inventory of the Product, for a period of no more than one (1) year after the date of termination, provided that Simcere continues to pay Kazia royalties on the Net Sales of the Product sold after termination in accordance with Section 5.5.

(viii)    Product Marks. Upon early termination of this Agreement for any reason, Simcere shall assign to Kazia all Product Marks that relate exclusively to the Product (which, for clarity, exclude the corporate names and logos of Simcere, its Affiliates and sublicensees). Simcere must also provide to Kazia all records, information and documents related to the registration and maintenance of any Product Marks which will be transferred to Kazia in accordance with this Section 8.3(b)(viii).

(ix)    Transition Assistance. Upon early termination of this Agreement for any reason, at Kazia’s reasonable request and expense, Simcere shall provide assistance to Kazia as may be reasonably necessary or useful for Kazia to commence or continue the Development, Manufacture or Commercialization of the Product in the Field in the Territory, for a period of no more than six (6) months after the effective date of such termination, and to the extent Simcere is then performing or having performed such activities, including transferring or amending as appropriate, upon Kazia’s request, any contracts with Third Parties for services related to the Development, Manufacture or Commercialization of the Product in the Field in the Territory. If any such contract is not assignable to Kazia, then Simcere shall reasonably cooperate with Kazia in its efforts to obtain such services from such Third Party.

(c)    Return of Confidential Information. Upon early termination of this Agreement for any reason, each Party must (i) immediately cease using all Confidential Information of or relating to the other Party (or the other Party’s Affiliate), (ii) deliver to the other Party all documents and other materials in its possession or control containing, recording or constituting that Confidential Information or destroy, and certify to the other Party that it has destroyed, those documents and materials, and (iii) for Confidential Information stored electronically, permanently delete that Confidential Information from all electronic media on which it is stored, so that it cannot be restored. Notwithstanding the foregoing, a Party shall be permitted to retain a copy (or copies, as necessary) of Confidential Information of or relating to the other Party which it has the right to retain under this Agreement, or otherwise for archival purposes or as required by any applicable Law, and neither Party shall be required to delete or destroy any electronic back-up tapes or other electronic back-up files that have been created by automatic or routine archiving and back-up procedures, to the extent created and retained in a manner consistent with standard archiving and back-up procedures. For the avoidance of doubt, the confidentiality obligations under Article 7 will continue to apply to any retained Confidential Information.

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(d)    Clinical Trial Transition Assistance. The Parties agree to provide reasonable run off and transitional assistance if a clinical trial is ongoing as at the date of expiration or termination of this Agreement, to ensure trial participants affected by termination receive adequate medical care, provided that if Kazia wishes to continue such clinical trial, then Kazia shall be bear the cost of such transition.

8.4    Survival. Expiration or termination of this Agreement shall not relieve the Parties of any obligation accruing prior to such expiration or termination. Without limiting the foregoing, the following provisions shall survive the expiration or termination of this Agreement: Sections 5.11, 6.1, 6.7(a), Article 7, Sections 8.3, 8.4, and 8.5, Article 10 and Article 11.

8.5    Termination Not Sole Remedy. Termination is not the sole remedy under this Agreement and, whether or not termination is effected and notwithstanding anything contained in this Agreement to the contrary, all other remedies shall remain available except as agreed to otherwise herein.

ARTICLE 9

REPRESENTATIONS AND WARRANTIES

9.1    Mutual Representations and Warranties. Each Party hereby represents, warrants, and covenants (as applicable) to the other Party as follows:

(a)    it is a company or corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction in which it is incorporated, and has full corporate power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as contemplated in this Agreement, including, without limitation, the right to grant the licenses granted by it hereunder;

(b)    as of the Effective Date, (i) it has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder; (ii) it has taken all necessary corporate action on its part required to authorize the execution and delivery of the Agreement and the performance of its obligations hereunder; and (iii) the Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, and binding obligation of such Party that is enforceable against it in accordance with its terms;

(c)    it is not a party to any agreement that would materially prevent it from granting the rights granted to the other Party under this Agreement or performing its obligations under the Agreement; and

(d)    it shall comply in all material aspects with all applicable Laws in the course of performing its obligations and exercising its rights under this Agreement.

9.2    Additional Representations and Warranties of Kazia. Kazia represents, warrants, and covenants (as applicable) to Simcere that, as of the Effective Date:

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(a)    Kazia is the sole owner of the Licensed IP (other than Licensed IP that is in-licensed by Kazia from Genentech under the Genentech Agreement), free and clear of all liens, and Kazia has the right to grant to Simcere the rights and licenses under the Licensed IP as purported to be granted hereunder;

(b)    Kazia has obtained all necessary government approvals required for the grant of the license and the transfer of the Licensed IP to Simcere, including such approvals required by applicable technology export control laws, and Kazia will do and execute or procure to be done and executed all such further acts, things, agreements and other documents as may be necessary to give effect to the terms of this Agreement, including to comply with the applicable technology import and export laws and regulations;

(c)    Kazia and its Affiliates have not granted, and will not grant during the Term, any rights in the Licensed IP that are inconsistent with the rights granted to Simcere under this Agreement;

(d)    to the best of their knowledge, Kazia and its Affiliates have not infringed or misappropriated any intellectual property of any Third Party during its development and manufacture of the Compound and Product, and have not received any notice from any Third Party asserting or alleging any such infringement;

(e)    to the best of Kazia’s knowledge, after undertaking the inquiries set out in Exhibit I, the Development, Manufacture and Commercialization (as contemplated by the Parties as of the Effective Date) of the Compound and Product (as such Compound and Product exist as of the Effective Date) can be carried out under this Agreement without infringing or misappropriating any intellectual property rights of any Third Party; there is no pending or, to the knowledge of Kazia and its Affiliates, alleged or threatened, adverse actions, suits, proceedings, or claims against Kazia or its Affiliates involving the Licensed IP, Compound or Product;

(f)    to the best of their knowledge, Kazia and its Affiliates are not aware of any infringement or misappropriation of any Licensed IP by any Third Party;

(g)    Exhibit B includes all Patents Controlled by Kazia and its Affiliates as of the Effective Date that claim or cover the Compound and Product, all of which have been diligently prosecuted and maintained in accordance with applicable Laws;

(h)    there is no pending or, to the knowledge of Kazia and its Affiliates, alleged or threatened, re-examination, opposition, interference or litigation, or any written communication alleging that any Licensed Patent is invalid or unenforceable anywhere in the world;

(i)    Kazia (including its Affiliates and, to the best of its knowledge, its contractors) has complied with all applicable Laws in connection with the development of the Compound and Product, and has not used any employee, consultant or contractor who has been debarred by any Regulatory Authority, or to its knowledge, is the subject of a debarment proceeding by any Regulatory Authority;

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(j)    except for the Genentech Agreement, there is no agreement between Kazia or its Affiliates and any Third Party pursuant to which Kazia or its Affiliates obtained any right or license to the Compound or Product or any intellectual property rights related to the Compound or Product;

(k)    Kazia has provided Simcere with a true and complete copy of the Genentech Agreement, and the Genentech Agreement is in full force and effect; Kazia has the right to grant to Simcere the sublicense under the Genentech Agreement as purported to be granted hereunder; no written notice of default or termination has been received or given under the Genentech Agreement; and there is no act or omission by Kazia that would provide a right to terminate the Genentech Agreement;

(l)    during the Term of this Agreement, Kazia shall, at its own cost and expense, use best efforts to maintain the Genentech Agreement in full force and effect and shall not terminate, amend, waive or otherwise modify (or consent to any of the foregoing) its rights under the Genentech Agreement in any manner that materially diminishes the rights or licenses granted to Simcere hereunder, without first notifying Simcere and shall obtain Simcere’s consent (not to be unreasonably withheld). If despite of Kazia’s best efforts, the Genentech Agreement is terminated, Kazia shall use best efforts to assist Simcere to obtain a direct license from Genentech. Where Simcere obtains a direct license from Genentech, the payment provisions of this Agreement will apply as though such license continued to be granted by Kazia, save that Simcere may deduct from any payment due to Kazia under this Agreement any payment Simcere is obliged to make to Genentech under its license agreement with Genentech. In such circumstances, Kazia shall have the right (limited to Section 5.11) to audit and confirm any payments due to Genentech under Simcere’s license agreement with Genentech;

(m)    in the event of any notice of breach of the Genentech Agreement by Kazia in a manner that will or is likely to affect Simcere’s rights or obligations under this Agreement, Kazia shall immediately notify Simcere in writing, and if Kazia fails to cure such breach in a timely manner, Simcere shall have the right, but not the obligation, to cure such breach and to seek reimbursement of or offset any reasonable amount incurred or paid by Simcere in connection with the cure against amount payable to Kazia hereunder;

(n)    in the event of any notice of breach of the Genentech Agreement by Genentech in a manner that will or is likely to materially affect Simcere’s rights or obligations under this Agreement, Kazia shall immediately notify Simcere in writing and, where it is reasonable for Kazia to do so, take reasonable actions requested by Simcere to enforce the Genentech Agreement; and

(o)    to the best of Kazia’s knowledge, all information provided by Kazia to Simcere for due diligence purposes in relation to this Agreement is complete and accurate in all material respects. Without limiting the foregoing, to the best of its knowledge, Kazia has disclosed to Simcere and made available to Simcere for review all material non-clinical and clinical data for the Compound and Product, and all other material information (including relevant correspondence with Regulatory Authorities) relating to the Compound and Product, in each case that would be material for Simcere to assess the safety and efficacy of the Compound and Product.

37

9.3    Additional Representations and Warranties of Simcere. Simcere represents, warrants, and covenants (as applicable) to Kazia that, as of the Effective Date and on each day during the Term, in conducting activities contemplated under this Agreement, Simcere will:

(a)    hold the necessary Regulatory Approvals to perform its obligations under this Agreement;

(b)    comply with all applicable Laws, including those related to Manufacture, use, labelling, importation and marketing of Products;.

9.4    Disclaimer. TO THE EXTENT PERMITTED BY LAW, EXCEPT AS EXPRESSLY STATED HEREIN, NO OTHER REPRESENTATIONS OR WARRANTIES WHATSOEVER, INCLUDING WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, IS MADE OR GIVEN BY OR ON BEHALF OF A PARTY. ALL SUCH OTHER REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED. Both Parties understand that the Compound and Product are the subject of ongoing research and development and neither Party can assure that any Compound or Product can be successfully Developed and Commercialized.

ARTICLE 10

INDEMNIFICATION; LIABILITY

10.1    [***]

(a)    [***]

(b)    [***]

[***]

(c)    [***]

(d)    [***]

10.2    [***]

(a)    [***]

(b)    [***]

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(c)    [***]

(d)    [***]

10.3    [***]

10.4    [***]

10.5    Limitation of Liability. SUBJECT TO SECTION 10.6, NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES.

10.6    Personal Injury. Nothing in this Agreement operates to exclude or restrict a Party’s liability for personal injury.

39

10.7    Insurance. Each Party shall procure and maintain insurance, including product liability insurance, with respect to its activities hereunder and which is consistent with normal business practices of prudent companies similarly situated at all times during which any Product is being clinically tested in human subjects or commercially distributed or sold by such Party. Each Party shall provide the other Party with evidence of such insurance upon request and shall provide the other Party with written notice at least sixty (60) days prior to the cancellation, non-renewal or material changes in such insurance. Such insurance shall not be construed to create a limit of either Party’s liability under this Agreement.

ARTICLE 11

GENERAL PROVISIONS

11.1    Force Majeure. Neither Party shall be held liable to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in performing any obligation under this Agreement to the extent such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party, potentially including embargoes, war, acts of war (whether war be declared or not), acts of terrorism, insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, fire, floods, earthquakes, pandemic, or other acts of God, or acts, omissions or delays in acting by any Government Authority (each a “Force Majeure Event”). The affected Party shall notify the other Party in writing of a Force Majeure Event, including the circumstances of that Force Majeure Event, as soon as reasonably practical, and shall promptly undertake and continue diligently all reasonable efforts necessary to cure the Force Majeure Event or to perform its obligations in spite of the ongoing circumstances. If a Force Majeure Event continues for more than eighteen (18) months and while it continues, the Party other than the affected Party may, at its sole discretion, terminate this Agreement by giving written notice to the affected Party.

11.2    Assignment. This Agreement may not be assigned or otherwise transferred, nor may any right or obligation hereunder be assigned or transferred, by either Party without the prior written consent of the other Party. Notwithstanding the foregoing, either Party may, without consent of the other Party, assign this Agreement and its rights and obligations hereunder in whole or in part to an Affiliate of such Party, or in whole to its successor in interest in connection with the sale of all or substantially all of its business or assets to which this Agreement relates. Any attempted assignment not in accordance with the foregoing shall be null and void and of no legal effect. Any permitted assignee shall assume all assigned obligations of its assignor under this Agreement. The terms and conditions of this Agreement shall be binding upon, and shall inure to the benefit of, the Parties and their respected successors and permitted assigns.

11.3    Severability. If any one or more of the provisions contained in this Agreement is held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein shall not in any way be affected or impaired thereby, unless the absence of the invalidated provision(s) adversely affects the substantive rights of the Parties. The Parties shall in such an instance use their best efforts to replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) which, insofar as practical, implement the purposes of this Agreement.

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11.4    Notices. All notices which are required or permitted hereunder shall be in writing and sufficient if delivered personally, sent by facsimile (and promptly confirmed by personal delivery, registered or certified mail or overnight courier), sent by nationally-recognized overnight courier, sent by registered or certified mail, postage prepaid, return receipt requested or sent by email, addressed as follows:

If to Kazia:
	Kazia Therapeutics, Ltd.
	L24, 300 Barangaroo Avenue
	Sydney, NSW 2000
	Australia
	Attn:           Chief Executive Officer
	Email:         [***]
with a copy to:
	K&L Gates
	L25, 525 Collins Street
	Melbourne, VIC 3000
	Australia
	Attn:         [***]
	Fax:          +61 3 9205 2055
	Email:       [***]
If to Simcere:
	Jiangsu Simcere Pharmaceutical Co, Ltd.
	No. 699-18 Xuanwu Avenue, Xuanwu District
	Nanjing City, Jiangsu Province
	China 210042
	Attn:         Corporate Counsel
	Fax:          +86 25 8526 2330
with a copy to:
	Simcere of America, Inc
	20 Acorn Park Drive, Suite 200,
	Cambridge, MA 02140
	Attn: [***], SVP, BD
	Telephone: (857)242-4364 x1005
	E-mail: [***]

41

and a copy to:
	Cooley LLP
	IFC - Tower 2, Level 35, Unit 3510
	8 Century Avenue
	Pudong New Area
	Shanghai, China 200120
	Attn:         [***]
	Fax:          +86 21 6030 0700

or to such other address(es) as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. Any such notice shall be deemed to have been given: (a) when delivered if personally delivered or sent by facsimile on a business day (or if delivered or sent on a non-business day, then on the next business day); (b) on the third (3^rd) business day after dispatch if sent by nationally-recognized overnight courier; (c) on the seventh (7^th) business day following the date of mailing, if sent by mail; or (d) if sent by email, two (2) hours after the time the email is sent to the recipient’s email address, as recorded on the sender’s email system, unless the sender receives within that time period, an automatic notification (other than an out of office message) indicating that the email has not been delivered.

11.5    Governing Law. This Agreement shall be governed by and construed in accordance with the laws of Singapore, without reference to any rules of conflict of laws that may require the application of the laws of a different jurisdiction.

11.6    Dispute Resolution

(a)    The Parties shall negotiate in good faith and use good faith efforts to settle any dispute, controversy or claim arising from or related to this Agreement or the breach thereof. Any such dispute, controversy or claim shall be referred to the Executive Officers of the Parties for attempted resolution. In the event the Executive Officers are unable to resolve such dispute, controversy or claim within thirty (30) days after such matter is referred to them, then, upon the written request of either Party, such dispute, controversy or claim shall be (i) if arising from or related to Section 5.11(d), referred to an Expert and determined in accordance with Exhibit H, or (ii) if arising from or related to any section of this Agreement other than Section 5.11(d) finally resolved by binding arbitration administered by Singapore International Arbitration Centre (“SIAC”) pursuant to its arbitration rules. Judgment on the arbitration award may be entered in any court having jurisdiction thereof.

(b)    If a dispute it to be resolved by arbitration under Section 11.6(a)(ii), the arbitration shall be conducted by a single arbitrator mutually agreed by the Parties within thirty (30) days after initiation of arbitration. If the Parties are unable or fail to agree upon the arbitrator, the arbitrator shall be appointed by SIAC. The arbitration shall be held in Singapore, all arbitration proceedings and communications shall be in English and the following terms shall apply:

(i)    Either Party may apply to the arbitrator for interim injunctive relief until the arbitration award is rendered or the controversy is otherwise resolved. Either Party also may, without waiving any remedy under this Agreement, seek from any court having jurisdiction any injunctive or provisional relief necessary to protect the rights or property of that Party pending the arbitration award. The arbitrator shall have no authority to award punitive or any other type of damages not measured by a Party’s compensatory damages.

42

(ii)    The “prevailing” Party, as determined by the arbitrator, shall be entitled to (A) its share of fees and expenses of the arbitrators, and (B) its reasonable attorneys’ fees and associated costs and expenses. If the arbitrator determines that, given the scope of the arbitration, neither Party “prevailed”, the arbitrator shall order that the Parties (A) share equally the fees and expenses of the arbitrator’s fees and any administrative fees of arbitration, and (B) bear their own attorney’s fees and associated costs and expenses.

(iii)    Except to the extent necessary to confirm an award or as may be required by Law, neither a Party nor an arbitrator may disclose the existence, content, or results of an arbitration without the prior written consent of both Parties. In no event shall an arbitration be initiated after the date when commencement of a legal or equitable proceeding based on the dispute, controversy or claim would be barred by the applicable statute of limitations.

(c)    Notwithstanding the foregoing, in the event of a dispute with respect to the validity, scope, enforceability or ownership of any Patent or other intellectual property rights, and such dispute is not resolved by the Executive Officers as set forth in Section 11.6(a), such dispute shall not be submitted to an arbitration proceeding and instead, unless otherwise agreed by the Parties in writing, either Party may initiate litigation in a court of competent jurisdiction in any country in which such rights apply.

11.7    Entire Agreement; Amendments. This Agreement, together with the Exhibits hereto, contains the entire understanding of the Parties with respect to the subject matter hereof. Any other express or implied agreements and understandings, negotiations, writings and commitments, either oral or written, with respect to the subject matter hereof are superseded by the terms of this Agreement. The Exhibits to this Agreement are incorporated herein by reference and shall be deemed a part of this Agreement. This Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by authorized representative(s) of both Parties hereto.

11.8    Headings; Language. The captions to the several Articles, Sections and subsections hereof are not a part of this Agreement, but are merely for convenience to assist in locating and reading the several Articles and Sections hereof. This Agreement was prepared in the English language, which language shall govern the interpretation of, and any dispute regarding, the terms of this Agreement.

11.9    Independent Contractors. It is expressly agreed that Kazia and Simcere shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture or agency. Neither Kazia nor Simcere shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other Party, without the prior written consent of the other Party.

11.10    Waiver. The waiver by either Party hereto of any right hereunder, or of any failure of the other Party to perform, or of any breach by the other Party, shall not be deemed a waiver of any other right hereunder or of any other breach by or failure of such other Party whether of a similar nature or otherwise.

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11.11    Cumulative Remedies. No remedy referred to in this Agreement is intended to be exclusive, but each shall be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under Law.

11.12    Waiver of Rule of Construction. Each Party has had the opportunity to consult with counsel in connection with the review, drafting and negotiation of this Agreement. Accordingly, the rule of construction that any ambiguity in this Agreement shall be construed against the drafting Party shall not apply.

11.13    Business Day Requirements. In the event that any notice or other action or omission is required to be taken by a Party under this Agreement on a day that is not a business day then such notice or other action or omission shall be deemed to be required to be taken on the next occurring business day.

11.14    Counterparts. This Agreement may be executed in two or more counterparts by original signature, facsimile or PDF files, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

(REMAINDER OF PAGE INTENTIONALLY LEFT BLANK)

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IN WITNESS WHEREOF, the Parties intending to be bound have caused this License Agreement to be executed by their duly authorized representatives as of the Effective Date.

Executed by Simcere Pharmaceutical Co., Ltd.:

Signature of Chief Executive Officer

/s/ Jinsheng Ren

Jinsheng Ren

Name (please print)

Executed by Kazia Therapeutics, Ltd. AC 063 259 754 in accordance with section 127(1) of the Corporations Act 2001 (Cth):

Signature of director	Signature of director or company secretary*
	*delete whichever does not apply
Name (please print)	Name (please print)

IN WITNESS WHEREOF, the Parties intending to be bound have caused this License Agreement to be executed by their duly authorized representatives as of the Effective Date.

Executed by Simcere Pharmaceutical Co., Ltd.:

Signature of Chief Executive Officer

Jinsheng Ren

Name (please print)

Executed by Kazia Therapeutics, Ltd. ACN 063 259 754 in accordance with section 127(1) of the Corporations Act 2001 (Cth):

	Signature of director or company secretary*
	*delete whichever does not apply
/s/ James Garner	/s/ Kate Hill
James Garner	Kate Hill
Chief Executive Officer	Company Secretary
Name (please print)	Name (please print)

[***]

[***]

Exhibit C:Technology Transfer Plan

1. Project Scope:

Upon execution of the Agreement the Parties will effect transfer of the Key Items listed below from Kazia to Simcere. Technology transfer for manufacturing will be elected by Simcere and a detailed plan will be discussed and agreed between the Parties.

[***]

[***]

4. Governance and Support

JSC will oversee the Technology Transfer.

For data and information that is necessary for regulatory filing and Development of the Compound or Product in the Territory but not under Kazia’s control, Kazia will reasonably assist Simcere to seek to acquire such data and information, at Simcere’s sole expense.

Exhibit D:Endpoints of GBM AGILE

The primary endpoint of GBM AGILE will be Overall Survival (OS), defined as the time from randomization to death from any cause. Patients still alive at the time of an analysis will be considered censored at their date of last contact.

Paxalisib will be deemed to have met its primary endpoint if the final probability of HR [Hazard Ratio] < 1.0 is at least 0.98, based on Kaplan-Meier analysis of the Intent-to-Treat dataset.

The Parties acknowledge that, as of the Effective Date, Kazia and GCAR are in discussion with NMPA regarding the design and conduct of GBM AGILE in China. In the event that NMPA recommends additional requirements or criteria for GBM AGILE, then “successful completion of GBM AGILE” shall also require that such additional requirements or criteria are met by GBM AGILE.

Exhibit E: Pharmacovigilance Terms

1.    Definitions

In this Exhibit E:

“Adverse Event” means an untoward medical occurrence in a patient or clinical investigation subject administered a Product and which does not necessarily have to have a causal relationship with this treatment. An Adverse Event can therefore by any unfavourable and/or unintended sign (including an abnormal laboratory find, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse Events may also include pre- or post-treatment complications that occur as a result of protocol mandated procedures, lack of efficacy, overdose or drug abuse/misuse reports. Pre- existing events that increase in severity or change in nature during or as a consequence of participation in a clinical study with all be considered Adverse Events;

“FDA” means the U.S. Food and Drug Administration;

“Investigator Brochure” means a comprehensive document summarizing the body of information about an investigational product (“IP” or “study drug”) obtained during preclinical and clinical development, compiled in accordance with the principles described by the International Committee for Harmonisation; and

“SUSAR” means a serious, unexpected or suspected Adverse Reaction.

2.    Reporting to Regulatory Authorities

Simcere shall be responsible for all necessary safety data reporting to Regulatory Authorities within the Territory, in accordance with applicable Laws. Kazia shall be responsible for all necessary safety data reporting to Regulatory Authorities outside the Territory, in accordance with applicable Laws.

At Kazia’s reasonable request, Simcere shall promptly provide a copy of any safety data reported to Regulatory Authorities within the Territory.

Simcere shall promptly notify Kazia of any questions, directives, or other communications received from a Regulatory Authority in the Territory in relation to the safety of the Licensed Product.

3.    Adverse Events During Development

3.1    Adverse Event Collection. All Adverse Events occurring during a clinical trial of the Licensed Product sponsored by Simcere shall be collected in a customary manner, including without limitation:

(a)    verbatim description;

(b)    onset and duration;

(c)    treatment;

(d)    severity, according to NCI Common Terminology Criteria for Adverse Events;

(e)    relatedness, per investigator assessment; and

(f)    outcome, and action taken in response to study drug

Simcere must report this data to Kazia in aggregate, de-identified form at the conclusion of the clinical trial, or at any interim analysis of safety data.

3.2    SUSARs. Any SUSAR to the Licensed Product must be reported to Kazia within 72 hours of Simcere becoming aware, even if full information is not available, so that Kazia may satisfy its regulatory obligations to FDA and other Regulatory Authorities. Simcere will reasonably cooperate with Kazia to investigate any SUSARs, and to resolve any queries from Regulatory Authorities.

3.3    Pregnancies. Simcere shall notify Kazia within 24 hours of becoming aware of any patients who become pregnant while being treated with the Licensed Product, or within 28 days of the last dose of the Licensed Product. Simcere will reasonably cooperate with Kazia to monitor the course and outcome of such pregnancies, and to resolve any queries from Regulatory Authorities.

3.4    Clinical Hold. In the event of a Regulatory Authority instituting a ‘clinical hold’ in respect of the Licensed Product, whereby a sponsor is directed to suspend administration of investigational product to trial patients, the Parties will promptly and reasonably collaborate to determine the appropriate course of action in the Territory.

4.    Adverse Events following obtainment of MA

For all post-market monitoring of the Licensed Product in the Territory, Simcere and Kazia shall reach an agreement before filing of a new drug application in the Territory.

5.    Simcere’s responsibilities to Kazia

(a)    Simcere shall provide to Kazia, in the form of line listings, such safety information as Kazia may reasonably request for preparation of Development Safety Update Reports or similar reports to Regulatory Authorities. Kazia shall provide Simcere with at least thirty (30) calendar days’ notice prior to the data lock point, and Simcere shall provide the requested information no later than fifteen (15) calendar days after the data lock point. Kazia may request such tabulations at no more than a quarterly frequency.

(b)    Simcere shall perform customary surveillance for emerging safety signals. Any material new safety signals shall be promptly shared with Kazia and the Parties shall cooperate to assess their impact and appropriate responses both in and outside the Territory.

6.    Kazia’s responsibilities to Simcere

(a)    Kazia shall maintain an up-to-date Investigator Brochure for the Licensed Product, containing customary summaries of safety information and an updated risk-benefit analysis, and shall provide that Investigator Brochure to Simcere no less than once per annum for their translation and appropriate distribution.

(b)    Kazia shall provide to Simcere a copy of the Development Safety Update Report (DSUR) that is prepared on an annual basis for submission to the FDA for Simcere’s information and reference.

(c)    Kazia shall establish and maintain a global safety database for the Licensed Product and shall perform customary surveillance for emerging safety signals. Any material new safety signals shall be promptly shared with Simcere and the Parties shall cooperate to assess their impact and appropriate responses in the Territory.

(d)    Kazia shall promptly notify Simcere of any SUSARs occurring in clinical trials of the Licensed Product outside of the Territory, and shall reasonably assist Simcere in reporting such events to IRBs, Regulatory Authorities, investigators, and other relevant parties.

7.    General obligations

(a)    Each Party shall have in place customary and appropriate policies, standard operating procedures, processes, and personnel to ensure that it is able to satisfy its obligations under this Exhibit E and under applicable Laws.

(b)    All safety information exchanged under this Exhibit E shall be considered Confidential Information of the Disclosing Party.

(c)    English will be used as the common language for all safety information exchanged between the Parties.

Exhibit F: Supply Terms

1.     Definitions

In this Exhibit F:

“Accepted Purchase Order” has the meaning given to it in item 3.2(a) of this Exhibit F;

“Defective Product” has the meaning given to it in item 5.3(b) of this Exhibit F;

“Defective Products Notice” has the meaning given to it in item 5.3(b) of this Exhibit F;

“Delivery Point” means a port in the Territory designated by Simcere;

“Forecast” has the meaning given to it in item 4 of this Exhibit F;

“GMP” means then-current applicable standards for the manufacture of pharmaceutical products, including, as applicable, the standards detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Parts 4, 210, 211, 601, 610 and 820, European Directive 2003/94/EC and Eudralex 4, ICH Q7 ICH guidance Q7 Good Manufacturing Practices, the PIC/S Guide to Good Manufacturing Practice for Medicinal Products, PE009-8, published by the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme dated 15 January 2009 (as adopted by Therapeutics Goods (Manufacturing Principles) Determination No. 1 of 2013), and corresponding regulations in the Territory;

“Minimum Lead Time” means the minimum period between the date of submitting a Purchase Order to Kazia and the delivery date for the Compound or Product, as the case may be, being three (3) months; provided that the initial supply of the Compound and Product shall be provided as soon as possible to enable Simcere to start Development work.

“Price” means a price set out in Section 4.9(a) of the Agreement; and

“Purchase Order” has the meaning given to it in item 3.1 of this Exhibit F.

2.     Obligation to Supply

Regardless of any other provision of this Agreement, Kazia is not required to supply any Compound or Product to Simcere at any time when:

(a)    Kazia is not able to obtain or have manufactured Compound or Product; provided that if the Compound or Product is in short supply, Kazia shall allocate the available Compound and Product equitably between Kazia, Simcere and other third parties to whom Kazia’s has supply obligations, on a pro-rata basis based on forecasted requirements;

(b)    Simcere has not paid for Compound or Product previously supplied by Kazia for which payment is then due, unless the amount unpaid is the subject of a dispute in good faith and only that portion in dispute is unpaid; or

(c)    there has been any other material breach of this Agreement by Simcere that has not been duly remedied.

3. Orders

3.1    Purchase Orders. Simcere must order Compound and Products by completing a purchase order in the form approved (which approval not to be unreasonably withheld) by Kazia (“Purchase Order”) and submitting it to Kazia by email. All Purchase Orders submitted by Simcere to Kazia must (a) specify the quantity of Compound and/ or Product required by Simcere, and (b) specify a delivery date that is no earlier than the Minimum Lead Time after the date of the Purchase Order. All Purchase Orders shall be governed exclusively by the terms of this Agreement, and any term or condition in any purchase order, confirmation, invoice or other document furnished by Simcere or Kazia that is in any way inconsistent with the terms and conditions set forth in this Agreement is hereby expressly rejected.

3.2    Acceptance of Purchase Orders.

(a)    Unless Simcere is in breach of any term of this Agreement (including that the Purchase Order fails to take into account at least the Minimum Lead Time) and subject to item 2(a) of this Exhibit F in case of short supply and item 3.2(b) of this Exhibit F for Purchase Order that differs materially from Forecast, Kazia will use best endeavours to accept Purchase Orders which are within the Forecasts. On acceptance by Kazia, the Purchase Order becomes an Accepted Purchase Order.

(b)    Kazia may reject a Purchase Order in whole or in part if the amount of Compound or Product ordered is materially different (i.e. greater than twenty percent (20%) difference) to the quantity of the Compound or Product set out for that particular quarter in the applicable Forecast.

3.3    Unfilled Purchase Order.    If Kazia is, or expects to be, unable to satisfy a Purchase Order placed by Simcere under item 3.1 of this Exhibit F, whether before or after Kazia has accepted that Purchase Order under item 3.2 of this Exhibit F (a) Kazia must immediately notify Simcere of that fact, and (b) Simcere may cancel all or part of the relevant Purchase Order.

3.4    Cancellation or suspension of Accepted Purchase Orders. Subject to item 3.3 of this Exhibit F, an Accepted Purchase Order cannot be cancelled or suspended by either Party without the other Party’s prior written agreement and, in the case of cancelation or deferral by Simcere, then only on terms that Simcere will fully reimburse Kazia for any out-of-pocket cost (including manufacturing cost) incurred by Kazia as a result of that cancellation or deferral.

4. Forecasts

Simcere must provide to Kazia each calendar quarter during the Term unless and until Simcere itself commences Manufacturing or having Manufactured Compound or Product (as the case may be) in accordance with Section 4.9(b) of the Agreement, a rolling yearly forecast (broken down to quarter level) of Simcere’s anticipated volume requirements for the Compound and Product (“Forecast”). The Forecast represents Simcere’s estimate of requirements and is not binding.

5. Delivery of Finished Products

5.1    Delivery. Kazia will use reasonable endeavours to deliver the Compound and Products the subject of an Accepted Purchase Order to the Delivery Point at the date specified therein. Kazia will not be liable for any loss of any kind whatsoever caused directly or indirectly by any failure to deliver or any delay in delivery that is outside Kazia’s control.

5.2    Title and risk. Title to the Compound and Product will pass to Simcere from Kazia on payment in full by Simcere to Kazia in relation to the Compound or Product, as the case may be. Risk in the Compound and Product will pass to Simcere from Kazia on delivery of the Compound or Product, as the case may be, to the Delivery Point.

5.3 Defective Products

(a)    Simcere will use reasonable efforts to conduct a visual inspection of the Compound and Product on delivery.

(b)    If Simcere believes that any Compound or Products were, at the time of delivery, damaged or defective (“Defective Products”), within thirty (30) business days of delivery of the Compound or Products (or ten (10) business days after the discovery of the defect for non-obvious defects not reasonably susceptible to discovery upon receipt), Simcere may issue a written notice to Kazia rejecting the Defective Products (“Defective Products Notice”).

(c)    Following receipt by Kazia of a Defective Products Notice, Kazia may at its own cost (i) request access to Simcere’s premises and inspect the Defective Products, and/or (ii) instruct Simcere to either return the Defective Products to Kazia (or a designated third party) or to dispose of the Defective Products and Simcere must comply with such request.

(d)    If the cause of the Compound or Products being Defective Products was not to any extent caused by Simcere, Kazia must pay the cost of the return or disposal of the Defective Products undertaken in accordance with item 5.3(c)(ii) of this Exhibit F and, at Simcere’s option, either refund to Simcere any payments made by Simcere in respect of any Defective Products or replace the Defective Products.

(e)    If the cause of the Compound or Products being Defective Products was partly or solely caused by Simcere, Simcere must pay a portion of (i) the cost of the return or disposal of the Defective Products undertaken in accordance with item 5.3(c)(ii) of this Exhibit F, and (ii) the invoice relating to the Defective Products; which portion represents the extent to which Simcere’s action or inaction caused the Compound or Products to be Defective Products.

(f)    If the Parties do not agree whether a Product is Defective Product or the cause thereof, the Parties shall engage a mutually agreed independent third party laboratory to examine the Product in question.    The conclusion of such laboratory shall be final and binding upon the Parties, and the Party in error shall bear the cost of such laboratory examination.

6. Price, Invoicing and Payment

Simcere must pay to Kazia the Price for all Compound and Product that is delivered to Simcere in accordance with an Accepted Purchase Order. On, or within fifteen (15) days from the delivery of the Compound or Products to the Delivery Point, Kazia must provide an invoice to Simcere for the Price of the Compound or Products. Simcere must pay Kazia the amount invoiced within thirty (30) days after the later of the date on which Simcere receives the invoice and the Compound and/or Products (including customs clearance documents).

7.    Manufacture Cost Audit. Simcere shall have the right (similar to Section 5.11) to audit and confirm the Manufacturing Cost of the Product supplied by Kazia

8.    Regulatory/Quality Audit. Simcere shall have the right (similar to Section 4.13) to audit the regulatory, quality and compliance systems, procedures and practices of Kazia (and its contractor manufacturers, subject to Kazia’s audits rights under any agreement with its contractor manufacturer) relating to the Manufacture and supply of the Product.

[***]

[***]

[***]

[***]

Exhibit H:    Expert Determination

1. Delivering a Dispute Notice

(a)    If Simcere and Kazia have been unable to resolve any dispute arising between them in relation to any underpayment or overpayment reported by an Auditor under Section 5.11(d) (a “Financial Dispute”), then Simcere or Kazia may refer the Financial Dispute to an Expert for determination in accordance with this this Exhibit H.

(b)    For the purposes of this Exhibit H, the Expert is a person:

(i)    having appropriate qualifications and experience relevant to determining the Financial Dispute;

(ii)    who is agreed by the Parties or, failing agreement within five (5) business days, is nominated at the request of any Party by the Chinese Institute of Certified Public Accountants (“CICPA”) in accordance with CICPA’s rules and procedures (Rules); and

(iii)    who does not act, or whose firm does not act, generally for any Party.

2. Determination by Expert

The Expert:

(a)    must conduct its determination in accordance with the Rules, which Rules are taken to be incorporated into this Agreement;

(b)    will act as an expert and not as an arbitrator;

(c)    may determine the time, place and procedures (which will be as informal as is consistent with the proper conduct of the matter) for the determination by the Expert, having regard to the nature of the Financial Dispute and the provisions of this Agreement;

(d)    may communicate privately with the Parties or with their lawyers;

(e)    may or may not allow the appearance of lawyers on behalf of the Parties;

(f)    may accept written submissions from a Party in relation to the Financial Dispute, provided a copy of the submission is also given to all other Parties;

(g)    may co-opt other expert assistance;

(h)    must have regard to the fairness and reasonableness of any matters pertaining to the Royalty Dispute; and

(i)    must deal with any matter as expeditiously as possible and by no later than twenty (20) Business Days after referral to the Expert.

3. Obligations of Parties

If an Expert is required to resolve a Financial Dispute:

(a)    the Expert’s determination will, except in the case of manifest error, be final and binding on the Parties;

(b)    the Parties must attend the sessions with the Expert and make a determined and genuine effort to resolve the Financial Dispute as soon as reasonably possible;

(c)    without limiting item 3(b) of this Exhibit H, the Parties must use their best endeavours to make available to the Expert all information relevant to the Financial Dispute and which the Expert reasonably requires in order to resolve the Financial Dispute;

(d)    everything that occurs before the Expert must be in confidence and in closed session;

(e)    all discussions must be without prejudice;

(f)    each Party must pay its own costs of complying with this Exhibit H and the costs of the Expert and any other costs of complying with this Exhibit H must be shared half as to Simcere and half as to Kazia; and

(g)    the Parties must continue performing their obligations under this Agreement while the Financial Dispute is being resolved.

4. Other Proceedings

A Party may not commence court proceedings in respect of a Financial Dispute unless it has complied with the terms of the Agreement, and if applicable until the procedures in this Exhibit H have been followed in full, except where:

(a)    the Party seeks injunctive relief in relation to a Financial Dispute from an appropriate court where failure to obtain such relief would cause irreparable damage to the Party concerned; or

(b)    following those procedures would mean that a limitation period for a cause of action relevant to the issues in dispute will expire.

Exhibit I:    Inquires made by Kazia

At the time of Kazia’s license agreement with Genentech (October 2016):-

• Review of prior art documents cited in International Search Report

• Review of prior art documents cited in US prosecution

• Review of prior art documents citied in European application

• Review of patent agency correspondence in key territories

• Consultation with inventor (Dr Alan Olivero)

EX-4.20

Exhibit 4.20

CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT WAS OMITTED BY MEANS OF MARKING SUCH INFORMATION WITH BRACKETS (“[***]”) BECAUSE THE IDENTIFIED CONFIDENTIAL INFORMATION IS NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

LICENSE AGREEMENT

BY AND BETWEEN

EVOTEC

and

KAZIA

This LICENSE AGREEMENT (this “Agreement”) is entered into by and between Kazia Therapeutics Limited (ACN 063 259 754), a company existing under the laws of Australia, having a place of business at Three International Towers, L24, 300 Barangaroo Avenue, Sydney, NSW 2000, Australia (“Kazia”), and Evotec (France) SAS, a company existing under the laws of France, having a place of business at 195 Route d’Espagne, 31036 Toulouse, France (“Evotec”). Each of Evotec and Kazia is sometimes referred to individually herein as a “Party” and collectively as the “Parties”.

RECITALS

WHEREAS, Evotec and/or its Affiliates have developed and/or in-licensed under a license agreement between Evotec and Sanofi dated 30^th July 2015 (“Sanofi License”) certain technology, patent rights and proprietary materials related to EVT-801, a pre-clinical-stage, small molecule, orally available inhibitor of VEGFR3 for treating, preventing or delaying onset or progression of diseases in humans or as biomarkers or stratification makers; and

WHEREAS, Kazia desires to obtain from Evotec, and Evotec is willing to grant to Kazia exclusive rights to, and associated intellectual property in such molecule.

NOW, THEREFORE, in consideration of the mutual covenants contained herein, and for other good and valuable consideration, the Parties hereto, intending to be legally bound, hereby agree as follows:

1.    DEFINITIONS

Whenever used in this Agreement with an initial capital letter, the terms defined in this Article 1 shall have the meanings specified herein and therein.

1.1    “Adverse Event” means any untoward medical occurrence in a Clinical Trial subject or patient who is administered a Product, whether or not considered related to such Product, including any undesirable sign (including abnormal laboratory findings of clinical concern), symptom or disease associated with the use of such Product.

1.2    “Affiliate” means, with respect to any Party, any other Person that, directly or indirectly, controls, or is controlled by, or is under common control with, such Party. For purposes of this definition, “control” (including, with correlative meaning, the terms “controlled by” and “under the common control”) means (a) ownership of more than fifty percent (50%) of the shares of stock entitled to vote for the election of directors in the case of a corporation, or more than fifty percent (50%) of the equity interests in the case of any other type of legal entity, or, with respect to either of the foregoing, such lesser maximum percentage permitted in those jurisdictions where majority ownership by foreign entities is prohibited, (b) status as a general partner in any partnership, or (c) any other arrangement whereby a Person controls or has the right to control the board of directors of a corporation or equivalent governing body of an entity other than a corporation.

1.3    “Annual Net Sales” means, with respect to any Calendar Year, the aggregate amount of the Net Sales of Product sold in the Territory in such Calendar Year.

1.4    “Applicable Laws” means any national, federal, state or local laws, treaties, statutes, ordinances, rules and regulations, including any rules, regulations, guidance, guidelines or requirements of any Regulatory Authority having the binding effect of law, or of any national securities exchange or securities listing organization on which a Party’s or its Affiliates’ stock is publicly traded, or other government authority (other than a Regulatory Authority), legislative body or commission that are in effect from time to time during the Term and applicable to a particular activity under this Agreement.

1.5    “Business Day” means any day other than a Saturday, Sunday or public holiday in Germany and Australia.

1.6    “Calendar Quarter” means the period beginning on the Effective Date and ending on the last day of the calendar quarter in which the Effective Date falls, and thereafter each successive period of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31; provided that the final Calendar Quarter shall end on the last day of the Term.

1.7    “Calendar Year” means the period beginning on the Effective Date and ending on December 31 of the calendar year in which the Effective Date falls, and thereafter each successive period of twelve (12) months commencing on January 1 and ending on December 31; provided that the final Calendar Year shall end on the last day of the Term.

1.8    “Challenge” means any challenge to the validity or enforceability of any of the Licensed Patent Rights, including without limitation by (a) filing a declaratory judgment action, any claim, demand, action or cause of action for declaratory relief, damages or any other remedy or for an enjoinment, injunction or any other equitable remedy in which any of the Licensed Patent Rights is alleged to be invalid, not infringed or unenforceable, (b) citing prior art pursuant to 35 U.S.C. §301 or third party submission pursuant to 35 U.S.C. §122, filing third party observations in any of the Licensed Patent Rights, or (c) filing any interference, derivation proceeding, reexamination, inter partes review, opposition, cancellation, nullity or similar proceedings against or based on any of the Licensed Patent Rights in any country.

1.9    “Clinical Trial” means, collectively, any Phase 1 Clinical Trial, Phase 2 Clinical Trial or Phase 3 Clinical Trial, as applicable, conducted by or on behalf of a Party.

1.10    “Combination Product” means a single Product that includes, in combination with a Licensed Product, one or more therapeutically-active ingredients other than the Licensed Product that are sold in a single package or as a unit at a single price either as a fixed dosage form or as separate dosage forms.

1.11    “Commercialization” or “Commercialize” means any and all activities directed to the offering for sale and sale of a Product after Marketing Authorization has been received with respect to that Product, including (a) activities directed to marketing, promoting, detailing, distributing, importing, selling and offering to sell that Product, (b) conducting approved investigator-initiated Clinical Trials and/or any other Clinical Trials with respect to that Product with respect to which Marketing Authorization has been received or for a use that is subject of an investigator-initiated Clinical Trial, (c) interacting with Regulatory Authorities regarding the above, (d) seeking pricing approvals and reimbursement approvals (as applicable) for that Product in the Territory, and (e) undertaking health economics studies and other activities designed in order to achieve favorable pricing approvals and reimbursement approvals for that Product in the Territory. When used as a verb, “to Commercialize” and “Commercializing” means to engage in Commercialization and “Commercialized” has a corresponding meaning.

1.12    “Commercially Reasonable Efforts” means, with respect to the Research, Development, Manufacture or Commercialization of any Licensed Product, as applicable, the efforts and resources that are consistent with those used by a Party in the research, development, manufacture or commercialization of compounds and products of comparable market potential as such Licensed Product, taking into account all relevant factors including, as applicable, the stage of development, efficacy and safety relative to competitive products in the marketplace, actual or anticipated Regulatory Authority approved labeling, the nature and extent of market exclusivity (including patent coverage and regulatory exclusivity), the cost and likelihood of obtaining Marketing Authorization, and actual or projected profitability. For purposes of clarity, Commercially Reasonable Efforts is determined on a market-by-market basis for each Licensed Product or particular Product, and it is anticipated that the level of effort may be different for different markets and may change over time, reflecting changes in the status of each Licensed Product or Product and the market(s) involved.

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1.13    “Confidential Information” means (a) the terms of this Agreement and its subject matter, (b) all Licensed Technology, and (c) all information, Technology and Proprietary Materials belong to or relating to a Party, whether oral, graphic, electronic, written or in any other form, that is or should reasonably be regarded as confidential to the Party to whom it belongs or relates and that is disclosed or provided by or on behalf of a Disclosing Party to a Receiving Party.

1.14    “Control” or “Controlled” means (a) with respect to Technology or Patent Rights, the possession by a Party of the right to grant a license, sublicense, access or other right to such Technology or Patent Rights as provided herein, and (b) with respect to Proprietary Materials, the possession by a Party of the right to supply, or grant access or another right to, such Proprietary Materials to the other Party as provided herein.

1.15    “Cover” or “Covered” or “Covering” means, with respect to any Patent Rights, Licensed Product or Product, that the use, import, manufacture or sale of such Licensed Product or Product in a particular country by an unlicensed Third Party would infringe a Valid Claim within such Patent Rights.

1.16    “CTA” means (a) a Clinical Trial application or any successor application or procedure required to initiate clinical testing of a Product in humans in the Territory in accordance with Applicable Laws, and (b) all supplements and amendments to any of the foregoing.

1.17    “Development” or “Develop” means, with respect to a Licensed Product or Product, (a) all non-clinical and clinical drug development activities that are undertaken after the Initiation of the first GLP-toxicology study for such Licensed Product in order to file and maintain a Regulatory Filing or obtain Marketing Authorization for such Licensed Product or Product in the Territory up to the date of receipt of Marketing Authorization with respect to that Licensed Product or Product, including toxicology and pharmacology testing, the conduct of chemistry manufacturing and controls, test method development and stability testing, process development (including the manufacture of validation and engineering batches), formulation development, delivery system development, quality assurance and quality control development, statistical analysis and report writing; the conduct of Clinical Trials; preparing and filing and all regulatory affairs related to the foregoing, and (b) the conduct of manufacturing development activities. When used as a verb, “Developing” means to engage in Development and “Developed” has a corresponding meaning.

1.18    “Disclosing Party” means a Party to whom information belongs or relates.

1.19    “Distributor” means any Person that purchases any Product from Kazia or any of Kazia’s Affiliates or Sublicensees for the purpose of reselling that Product to end users in the Territory (including any wholesalers, pharmacists or hospitals).

1.20    “DMF” means a Drug Master File maintained with a Regulatory Authority in any country within the Territory.

1.21    “Effective Date” means the date of last signature under this Agreement.

1.22    “EMA” means the European Medicines Agency or any successor agency or authority thereto.

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1.23    “FDA” means the United States Food and Drug Administration, or any successor agency or authority thereto.

1.24    “FDCA” means the United States Federal Food, Drug, and Cosmetic Act, as amended.

1.25    “Field” means all therapeutic, prophylactic and diagnostic uses in humans.

1.26    “First Commercial Sale” means, with respect to any Product in any country in the Territory, the first sale, transfer or disposition for value of that Product in that country after Marketing Authorization for the Product has been received in that country; provided that the following shall not constitute a First Commercial Sale: (a) any sale by Kazia to an Affiliate, Sublicensee or Distributor (unless the Affiliate, Sublicensee or Distributor is the last entity in the distribution chain of the Product), (b) any use of a Product in Clinical Trials, pre-clinical studies or other Research or Development activities, or (c) the disposal or transfer of Products for a bona fide charitable purpose, including compassionate use and/or “named patient sales”.

1.27    “Force Majeure” means any occurrence beyond the reasonable control of a Party that (a) prevents or substantially interferes with the performance by such Party of any of its obligations hereunder, and (b) occurs by reason of any act of God, flood, fire, explosion, earthquake, strike, lockout, labor dispute, casualty or accident, or war, revolution, civil commotion, epidemic, pandemic, act of terrorism, blockage or embargo, or any injunction, law, order, proclamation, regulation, ordinance, demand or requirement of any government or of any subdivision, authority or representative of any such government.

1.28    “GLP” means the then-current Good Laboratory Practice Standards promulgated or endorsed by the FDA or in the case of any other country in the Territory, comparable regulatory standards promulgated or endorsed by that country, including those procedures expressed in or contemplated by any Regulatory Filings.

1.29    “GMP” means the then-current Good Manufacturing Practices that apply to the Manufacture (including clinical or commercial supply ) of each Licensed Product, including where applicable the United States regulations set forth under Title 21 of the United States Code of Federal Regulations, parts 210 and 211, as may be amended from time-to-time, as well as all applicable guidance published from time-to-time by the FDA and the ICH Guidelines ICHQ7A Good Manufacturing Practice Guidance for the principles and guidelines of Good Manufacturing Practices for Medicinal Products as defined with EC Directive 2003/94/EC and associated EC Guide to Good Manufacturing Practice.

1.30    “GCP” means the then-current good clinical practice applicable to the clinical Development of any Licensed Product or Product under Applicable Laws, including as applicable the ICH guidelines and U.S. Good Clinical Practice.

1.31    “Hatch-Waxman Act” means the Drug Price Competition and Patent Term Restoration Act of 1984, as amended.

1.32    “ICH” means the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

1.33    “Improvement” means any improvement, enhancement, modification, adaptation, extension, development, mutation, application of and all other technical advances made by or on behalf of a Person, whether or not protected by statute.

1.34    “IND” means (a) an investigational new drug application as defined in the FDCA and regulations promulgated thereunder or any successor application or procedure required to initiate clinical testing of a Licensed Product or Product in humans in the United States; (b) a foreign equivalent of an investigational new drug application that is required in any other country or region in the Territory before beginning clinical testing of a Licensed Product or Product in humans in such country or region; and (c) all supplements and amendments to any of the foregoing.

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1.35    “Indirect Taxes” means VAT, sales taxes, consumption taxes and other similar taxes required by law to be disclosed on an invoice.

1.36    “Initiation” means (a) with respect to a study, the commencement of such study, or (b) with respect to a Clinical Trial, the date on which the first subject or patient is dosed in such Clinical Trial.

1.37    “Knowledge” means, with respect to a Party, the actual knowledge of the officers of such Party.

1.38    “Licensed Patent Rights” means the Patent Rights listed on Exhibit A attached hereto.

1.39    “Licensed Product” means EVT-801 a pre-clinical-stage, small molecule, orally available inhibitor of VEGFR3 as set out in Exhibit C.

1.40    “Licensed Technology” means (a) Technology Controlled or in-licensed by Evotec or its Affiliates at the Effective Date which is reasonably required by Kazia for the Research, Development, Manufacture or Commercialization of the Licensed Product or Products as listed on Exhibit A, and (b) pursuant to Section 9.4, any Improvements thereof.

1.41    “MAA” means any application for Regulatory Approval submitted to the EMA pursuant to the centralized approval procedure to obtain European Commission approval for the marketing of a Product in the European Union, or any successor application or procedure required to sell a Product in the European Union.

1.42    “Manufacture” or “Manufacturing” or “Manufactured” means all activities related to the production of any clinical or commercial quantities of Licensed Product or Product, including, the manufacture, receipt, inspection, storage and handling of materials, and the manufacture, processing, purification, packaging, labeling, warehousing, quality control testing (including in-process release and stability testing), shipping and release of each such Licensed Product or Product.

1.43    “Marketing Authorization” means, with respect to any Product, the Regulatory Approval required by Applicable Laws to Commercialize such Product for use in a country or region in the Territory. For purposes of clarity (a) “Marketing Authorization” in the United States means final approval of an NDA or biological license application permitting marketing of such Product in interstate commerce in the United States, and (b) “Marketing Authorization” in the European Union means marketing authorization for such Product granted either by a Regulatory Authority in any European Country or by the EMA pursuant to Council Directive 2001/83/EC, as amended, or Council Regulation 2309/93/EEC, as amended.

1.44    “NDA” means a New Drug Application, as defined in the FDCA and regulations promulgated thereunder, or any successor application or procedure required to sell a Licensed Product or Product in the United States.

1.45    “Net Sales” means the gross invoiced amount on sales of the Products by or on behalf of Kazia and its Affiliates and Sublicensees to Third Parties after deduction of the following amounts, to the extent taken (a) normal and customary trade, quantity or prompt settlement discounts (including chargebacks and allowances) actually allowed, (b) amounts repaid or credited by reason of rejection, returns or recalls of goods, rebates or bona fide price reductions determined by Kazia or its Affiliates in good faith, (c) rebates and similar payments made with respect to sales paid for by any Regulatory Authority such as, by way of illustration and not in limitation of the Parties’ rights hereunder, Federal or state Medicaid, Medicare or similar state program in the United States or equivalent governmental program in any other country; (d) excise taxes, Indirect Taxes, customs duties, customs levies and import fees imposed on the sale, importation, use or distribution of the Products; for clarity, the portion of any annual fee on prescription drug manufacturers imposed by the United States Patient Protection and Affordable Care Act, Pub. L. No. 111-148 (as amended) or other similar governmental fee based on revenues from pharmaceutical products that may be allocated by Kazia, its Affiliates or its Sublicensees to sales of the Products shall not be considered for the purpose of this definition of Net Sales; (e) reasonable charges for insurance, freight, transportation costs directly related to the delivery of the Product; (f) any other similar and customary deductions that are consistent with international financial reporting standards, or other applicable accounting standards. Net Sales shall be calculated using Kazia’s internal audited systems used to report such sales as adjusted for any of items (a) to (f) above not taken into account in such systems. Deductions pursuant to subsection (d) above are taken in the Calendar Quarter in which such sales are no longer recorded as a receivable.

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Net Sales for a Combination Product shall be calculated by multiplying the actual Net Sales of such Combination Product in any country by the fraction A/(A+B), where A is the average gross invoice price in such country of a Product, containing the same amount of Licensed Product as the sole active ingredient as the Combination Product in question (a “Comparable Product”), if sold separately, and B is the average gross invoice price in the given country of the ready for sale form of a product containing the same amount of the other therapeutically active ingredient(s) in the Combination Product that are not Licensed Products (the “Other Ingredients”), if sold separately. If, on a country-by-country basis, the Other Ingredients are not sold separately in a country, Net Sales in such country for the purpose of determining royalties of the Combination Product shall be calculated by multiplying actual Net Sales of such Combination Product in such country by the fraction A/C where A is the average gross invoice price in such country of a Comparable Product, if sold separately, and C is the average gross invoice price of the Combination Product in such country. If, on a country-by-country basis, a Comparable Product is not sold separately, Net Sales in such country for the purpose of determining royalties of the Combination Product shall be calculated by multiplying actual Net Sales of such Combination Product by the fraction (C-B)/C, where B is the average gross invoice price in such country of the Other Ingredients and C is the average gross invoice price in such country of the Combination Product. For the purpose of the above, the average gross invoice price for a Comparable Product and for each Other Ingredient shall be for a quantity comparable to that used in the Combination Product in question and of the same class, purity and potency. If, on a country-by-country basis, neither a Comparable Product nor the Other Ingredients are sold separately in a country, Net Sales in such country for the purposes of determining royalties of such Combination Product shall be determined based on the ratio of the cost of the Licensed Product in the Combination Product to the sum of the cost of the Licensed Product in the Combination Product and the cost of the Other Ingredients in the Combination Product.

1.46    “Patent Costs” means the reasonable external costs and expenses incurred by Evotec(including reasonable attorneys’ fees) in preparing, filing, prosecuting or maintaining any Licensed Patents Rights in accordance with this Agreement. The Parties acknowledge that such costs may include reasonable pass through costs incurred by Sanofi in it preparing, filing, prosecuting or maintaining any Licensed Patents.

1.47    “Patent Rights” means the rights and interests in and to issued patents and pending patent applications (which, for purposes of this Agreement, include certificates of invention, applications for certificates of invention and priority rights) in any country or region, including all provisional applications, substitutions, continuations, continuations-in-part, divisions, renewals, all letters patent granted thereon, and all reissues, re-examinations, utility models, supplementary protection certificates, and extensions thereof, and all foreign counterparts of any of the foregoing.

1.48    “Person” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, incorporated association, joint venture or similar entity or organization, including a government or political subdivision, department or agency of a government.

1.49    “Phase 1 Clinical Trial” means a human clinical trial for a Product in any country that would satisfy the requirements of 21 CFR 312.21(a), or its successor regulation, or the equivalent in any foreign country.

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1.50    “Phase 2 Clinical Trial” means a human clinical trial conducted in any country that would satisfy the requirements of 21 CFR 312.21(b) or its successor regulation, or the equivalent in any foreign country and is intended to explore the safe and effective dose range for the proposed therapeutic indication of Product and other characteristics of safety and efficacy, for any Product in a patient population.

1.51    “Phase 3 Clinical Trial” means a clinical trial in any country in an extended human patient population designed to obtain data determining efficacy and safety of any Product to support Regulatory Approvals in a therapeutic indication, as more fully defined in 21 CFR 312.21(c), or its successor regulation, or the equivalent in any foreign country.

1.52    “Product” means any pharmaceutical or medicinal item, substance, formulation or dosage that comprises a Licensed Product as the active pharmaceutical ingredient. “Product” includes Combination Products.

1.53    “Proprietary Materials” means any tangible chemical, biological or physical materials that are Controlled by one Party and (a) are furnished by or on behalf of such Party to the other Party in connection with this Agreement, whether or not specifically designated as proprietary by the Party transferring that material, or (b) are otherwise conceived or reduced to practice by or on behalf of such Party in connection with the Research, Development, Manufacture or Commercialization of Products.

1.54    ”Receiving Party” means a Party to whom information is disclosed or who possesses or otherwise acquires information belonging or relating to a Disclosing Party.

1.55    “Regulatory Approval” means, with respect to any country or region in the Territory, any approval, product and establishment license, registration or authorization of any Regulatory Authority required for the Manufacture, use, storage, importation, exportation, transport or distribution of a Licensed Product or Product for use in such country or region.

1.56    “Regulatory Authority” means any national, international, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity with authority over the distribution, importation, exportation, Manufacture, production, use, storage, transport, clinical testing, pricing or sale of a Product in the Territory, including the FDA and the EMA.

1.57    “Regulatory Documentation” means any Regulatory Filings, submission, communications, correspondence, registrations and other filings made to, received from or otherwise conducted with a Regulatory Authority.

1.58    “Regulatory Filing” means, collectively (a) any IND, CTA, MAA, establishment license application, DMF, application for designation as an “Orphan Product” under the Orphan Drug Act, for “Fast Track” status under Section 506 of the FDCA (21 U.S.C. § 356) or for a Special Protocol Assessment under Section 505(b)(4)(B) and (C) of the FDCA (21 U.S.C. § 355(b)(4)(B)) and all other similar filings (including counterparts of any of the foregoing in any country or region in the Territory), (b) all supplements and amendments to any of the foregoing; and (c) all data and other information contained in, and correspondence relating to, any of the foregoing.

1.59    “Research” means, with respect to each Licensed Product, all research and non-clinical drug development activities that are undertaken with respect to such Licensed Product prior to Initiation of the first GLP-toxicology study conducted for such Licensed Product.

1.60    “Royalty Term” means, with respect to each Product in each country of the Territory, the period beginning on the date of First Commercial Sale of such Product in such country [***]

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1.61    “Second Indication” means a claim the subject of a Regulatory Approval received for a Product that is subsequent to the initial Regulatory Approval received for that Product, which claim is for a disease, disorder or medical condition which the Product can be used to diagnose, treat or prevent that is separate and distinct from the disease, disorder or medical condition listed in the initial Regulatory Approval for the Product.

1.62    “Sublicensee” means a Person, other than an Affiliate of Kazia, who is granted a sublicense in accordance with the provisions of this Agreement. For clarity, any Person to which a Sublicensee grants a further sublicense shall also be a Sublicensee.

1.63    “Tax” means any form of tax or taxation, levy, duty, charge, contribution, or withholding of whatever nature (including any related fine, penalty, surcharge or interest) imposed by, or payable to, a Tax authority.

1.64    “Technology” means, collectively, inventions, discoveries, improvements, trade secrets and proprietary methods, whether or not patentable, including: (a) methods of Manufacture or use of, and structural and functional information pertaining to, chemical compounds; and (b) compositions of matter, data, formulations, processes, techniques, know-how and results (including any negative results).

1.65    “Territory” means any country or territory in the world.

1.66    “Third Party” means a Person other than Kazia and Evotec and their respective Affiliates.

1.67    “Valid Claim” means any claim of a pending patent application to the extent such claim continues to be prosecuted in good faith or an issued unexpired patent that (a) has not been finally cancelled, withdrawn, abandoned or rejected by any administrative agency or other body of competent jurisdiction, (b) has not been permanently revoked, held invalid, or declared unpatentable or unenforceable in a decision of a court or other body of competent jurisdiction that is unappealable or unappealed within the time allowed for appeal, (c) has not been rendered unenforceable through terminal disclaimer or otherwise, and (d) is not lost through an interference proceeding that is unappealable or unappealed within the time allowed for appeal.

1.68    Additional Definitions. In addition, each of the following definitions have the respective meanings set forth in the section of this Agreement indicated below:

Definition	Section
Agreement	Preamble
Claims	13.1.
Comparable Product	1.45
Diligence Failure Notice	5.4
Disclosing Party	1.18
Evotec	Preamble
Evotec Diligence Failure	5.5
Evotec Indemnitees	13.1
Generic Entry	6.3.3
Generic Product	6.3.3
Indemnified Party	13.3
Indemnifying Party	13.3
Infringement	10.2.1(a)(i)
Infringement Notice	10.2.1(a)(i)
Infringement Response	10.2.1(a)(ii)
Kazia	Preamble
Kazia Diligence Failure	5.4
Kazia Indemnitees	13.2

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Definition	Section
Losses	13.1
Other Ingredients	1.45
Patent Coordinator	9.3
Party/Parties	Preamble
Payments	6.3.8
Receiving Party	1.54
Recovery	10.2.1(d)
Sanofi License	Recitals
Supply Agreement	3.3
Term	11.1
Third Party License	6.3.2
Upfront Payment	6.1

1.69    List of Exhibits.

Exhibit A                    Licensed Patent Rights and Licensed Technology (As of the Effective Date)

Exhibit B                    List of Countries for Patent Filing

Exhibit C                    Structure of EVT-801

Exhibit D                    Quote from Third Party provider for delivery of Licensed Product

2.    RESEARCH AND DEVELOPMENT

2.1    Objectives. The objective of conducting the Research and Development activities with respect to the Licensed Product under this Agreement is to progress Licensed Products and Commercialize Products.

2.2    Kazia Responsibilities. During Term, Kazia shall use Commercially Reasonable Efforts to conduct Research and Development activities, at its own cost and expense, in order to Commercialize Products. [***].

2.3    Evotec Responsibilities. Within sixty (60) days of the Effective Date, Evotec must provide to Kazia all Licensed Technology that exists on the Effective Date as set out at Exhibit A, including by (a) providing to Kazia all tangible Licensed Technology and, to the extent possible, copies of documents describing the intangible Licensed Technology, and (b) otherwise providing Kazia with access to intangible Licensed Technology. Upon Kazia’s reasonable request, for a period of one hundred and twenty (120) days of the Effective Date, Evotec shall also provide Kazia with reasonable technical assistance in connection with the Licensed Technology provided under this Section 2.3, including reasonable access to Evotec’s available technical personnel involved in the Research and Development of the Licensed Product and Products at no additional cost to Kazia.

2.4    Compliance. Kazia shall perform Research and Development activities for which it is responsible under this Agreement in compliance with all Applicable Laws. In conducting Research and Development activities, Kazia shall comply, as applicable, with GLPs, GMPs or GCPs (or, if and as appropriate under the circumstances, ICH guidance or other applicable comparable regulation or guidance of any Regulatory Authority in any country or region in the Territory).

2.5    Records; Reports. During the Term, Kazia shall maintain complete and accurate records of its Research and Development activities conducted in relation to the Licensed Product and any Products. Such records shall be kept in sufficient detail and in a manner that reflects all work done and results achieved. Kazia shall inform Evotec in writing of the progress of its Research and Development activities not less than once each Calendar Year by 31 October.

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3.    MANUFACTURING RIGHT

3.1    Kazia Manufacturing Rights. Kazia shall have the sole right and responsibility, at its sole cost and expense, to Manufacture and supply and/or obtain from Third Parties such quantities of each Licensed Product and Product as may be required by Kazia, including for all Clinical Trials.

3.2    Assignment of Licensed Product. Evotec herewith assigns to Kazia and Kazia herewith accepts such assignment of Evotec’s inventory of Licensed Products existing as of the Effective Date.

3.3    Supply Arrangement. Kazia and Evotec will separately and in good faith discuss a potential supply agreement in which Evotec shall continue to manufacture Licensed Product on Kazia’s behalf on commercial terms (“Supply Agreement”). If the Parties enter into a Supply Agreement, Kazia shall consider Evotec as a preferred supplier for any Manufacturing of the Licensed Product and/or supply services of the Licensed Product that are outsourced by Kazia.

4.    REGULATORY ACTIVITIES

4.1    Responsibility for Regulatory Filings. Kazia shall have the exclusive right and responsibility for (a) preparing, filing and maintaining all Regulatory Filings for each Product in its own name, (b) to the extent required by Applicable Laws, reporting to Regulatory Authorities any Adverse Events related to a Product that it is reasonably aware of, and (c) otherwise communicating and interacting with Regulatory Authorities with respect to Products prior and subsequent to Regulatory Approval.

4.2    Reports. Kazia shall, at its own cost and expense: (a) maintain records of its Regulatory Filings for each Product; and (b) inform Evotec on the progress of its Regulatory Filings not less than once each Calendar Year by 31 October.

4.3    Existing Documentation. Within sixty (60) days of the Effective Date, Evotec shall, at its own cost and expense, assign and provide to Kazia all of the Regulatory Documentation and any available Regulatory Approvals with respect to the Licensed Product Controlled by Evotec, if any, as of the Effective Date.

5.    COMMERCIALIZATION OF PRODUCTS

5.1    Responsibility. Kazia shall have the exclusive right and responsibility for Commercialization of Products in the Territory, at its sole cost and expense.

5.2    Reports. Kazia shall inform Evotec on the progress of its Commercialization plans not less than once each Calendar Year by 31 October.

5.3    Commercialization Diligence. Kazia shall use Commercially Reasonable Efforts during the Term to (a) Commercialize Products in the Territory and (b) commit such resources (including employees, consultants, contractors, facilities, equipment and materials) as it deems reasonably necessary to Commercialize such Products in the Territory.

5.4    Failure by Kazia to Satisfy Diligence Obligations. Evotec shall have the right, in its sole discretion, to provide Kazia with written notice if it reasonably believes Kazia has failed to satisfy its diligence obligations under Section 5.3 of this Agreement with respect to any Product in any country or countries in the Territory (a “Kazia Diligence Failure”). Such written notice (a “Diligence Failure Notice”) shall set forth in reasonable detail the nature of the alleged failure and shall request written justification, in the form of detailed reasons that would support the proposition that Kazia has satisfied such diligence obligations. The Parties shall meet within thirty (30) days after such notice to discuss in good faith Evotec’s concerns and Kazia’s plans for Development and Commercialization with respect to the applicable Product in the applicable country(ies). If, after such good faith discussions (a) Kazia remains reasonably found by Evotec in material breach of its obligations under Section 5.3 of this Agreement with respect to such Product in such country, and (b) Kazia does not take all reasonable steps designated to rectify such breach within ninety (90) days after meeting with Evotec pursuant to this Section 5.4 (or if such failure cannot be rectified within such ninety (90)-day period, if Kazia does not commence actions to rectify such breach within such period and thereafter diligently pursue such actions), then Evotec shall have the right, in its discretion, on a Product-by-Product basis as to the Product with respect to which such Kazia Diligence Failure occurred to (i) terminate any or all of the licenses and rights granted under Section 8.1.1 hereof with respect to the Product that is the subject of the Diligence Failure Notice, or (ii) convert the licenses and rights granted under any or all of Section 8.1.1 from exclusive licenses to non- exclusive licenses only as such licenses and rights apply to such Product, which termination or conversion, as the case may be, shall be at the discretion of Evotec and be effective immediately upon issuance by Evotec of written notice to Kazia specifying the remedy that Evotec is electing to exercise under this Section 5.4.

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5.5    Failure by Evotec to Satisfy Diligence Obligations. Evotec must notify Kazia immediately in writing upon receiving a written notice from Sanofi regarding any alleged failure by Evotec to satisfy its diligence obligations under the Sanofi License (“Evotec Diligence Failure”). If such Evotec Diligence Failure can reasonably be attributed to any action or inaction of Kazia resulting in a Kazia Diligence Failure, the terms of Section 5.4 shall apply provided, however, that in such case the time periods set out in Section 5.4 shall be adjusted to reflect the time periods applicable to the rectification or otherwise of the Evotec Diligence Failure under the Sanofi License.

6.    PAYMENTS

6.1    Upfront Payment. In consideration of the rights granted by Evotec to Kazia under this Agreement, Kazia shall pay Evotec a non-refundable fee of 1,000,000.00 (One million) Euros after execution of this Agreement and within thirty (30) Business Days after receipt of a valid tax invoice from Evotec. Such fee will be unconditional and as such shall not be subject to any offset, credit, reduction or repayment for any reason whatsoever, whether provided for in this Agreement or not.

In addition, Kazia will reimburse Evotec (at cost up to [***]) for the purchase of certain Licensed Product that are being purchased by Evotec from a third party provider similar in all material aspects as per the quotes set out in Exhibit D hereto.

6.2    Milestone Payments.

6.2.1    Development and Regulatory Milestones. Subject to Section 6.3.4, Kazia shall make the following one-time, non-refundable, non-creditable payments to Evotec within thirty (30) Business Days after receipt of a valid tax invoice from Evotec issued following the first achievement of the corresponding milestone event by Kazia or its Affiliates or Sublicensees:

Milestone Event	Milestone Payment
[***]
	[***]
Milestone Event                                                                     Milestone Payment
For the avoidance of doubt, the Parties agree that all payments under this Section 6.2.1 are payable only once, unless expressly noted.
6.2.2    Sales Milestones. In addition to the milestone payments contemplated by Section 6.2.1, Kazia shall make the following one-time, non-refundable, non-creditable payments to Evotec within thirty (30) Business Days after receipt of a valid tax invoice from Evotec issued following the first achievement of the corresponding milestone event by Kazia or its Affiliates or Sublicensees:

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Milestone Event

[***]

For the avoidance of doubt, the Parties agree that all payments under this Section 6.2.2 are payable only once.

6.2.3    Notice of Milestones.

(a)    Notice of Milestone Events. Kazia shall provide Evotec with prompt written notice upon the occurrence of each milestone event set forth in this Section 6.2. If Evotec believes any such milestone event has occurred and has not received a written notice of same from Kazia, it shall so notify Kazia in writing and shall provide to Kazia documentation or other information that supports its belief. Any dispute under this Section 6.2.3(a) that relates to whether or not a milestone event has occurred shall be resolved in accordance with Section 14.3.

6.3    Payment of Royalties; Royalty Rates; Accounting and Records.

6.3.1    Payment of Royalties. Kazia shall pay Evotec a royalty amount on Annual Net Sales in each Calendar Year of the Term, on a Product-by-Product basis, commencing with the First Commercial Sale of such Product in any country in the Territory and ending upon the last day of the last Royalty Term for such Product, at the following rates:

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Annual Net Sales within first 24 months from First		Royalty Rate (%)
Commercial Sale
All amounts	[***]

Annual Net Sales Increment following 24 months		Royalty Rate (%)
from First Commercial Sale [***]	[***]
[***]	[***]
[***]	[***]
[***]	[***]

6.3.2    Royalty Adjustment for Third Party Intellectual Property. If Kazia or its Affiliates or their Sublicensees, as applicable, determines, in its reasonable judgment, that it is necessary to obtain a license from any Third Party (a “Third Party License”) under any Valid Claim in order to avoid potential infringement or misappropriation of such Valid Claim by the importation, sale, manufacture or use of a Licensed Product, then the royalty payment that would otherwise be due in any Calendar Quarter pursuant to Section 6.3.1 shall be reduced, on a Calendar Quarter-by-Calendar Quarter basis, by fifty percent (50%) of any royalty amount payable by Kazia or its Affiliates or their Sublicensees in such Calendar Quarter to such Third Party in consideration for such Third Party License, in the event such Third Party License is obtained by Kazia or its Affiliate or their Sublicensees. Notwithstanding the foregoing, the royalty payment that would otherwise be due to Evotec pursuant to Section 6.3.1 with respect to any particular Calendar Quarter shall not be reduced by more than fifty percent (50%) by operation of this Section 6.3.2.

6.3.3    Royalty Adjustment in Certain Circumstances. On a Product-by-Product and country-by-country basis, if in any Calendar Quarter during the Royalty Term following introduction of a Generic Product in a country (“Generic Entry”) there is no Valid Claim within the Licensed Rights in such country then the applicable royalty payable to Evotec under Section 6.3.1 shall be reduced by fifty percent (50%). For the purposes of this Section 6.3.3, “Generic Product” means, with respect to a Product being sold by Kazia and its Affiliates or their Sublicensees or subcontractors, as applicable, any pharmaceutical product containing the same Licensed Product as that contained in such Product (and the same other active ingredient(s), as applicable, in the case of a Combination Product) which is marketed by an entity other than Kazia and its Affiliates or their Sublicensees or subcontractors, to the extent such Sublicensees or subcontractors are acting in their capacity as sublicensees or subcontractors of Kazia or its Affiliates, in the Field.

6.3.4    Sublicensing Revenues. If Kazia sublicenses Commercialization rights to any Sublicensee, Kazia shall pay to Evotec the greater of, at Evotec’s sole discretion, (i) the milestone and royalty payments pursuant to Sections 6.2 and 6.3, or (ii) in lieu of the then outstanding milestone and royalty payments under Sections 6.2 and 6.3, a percentage of any and all payments received by Kazia or its Affiliates from each such Sublicensee in consideration for such sublicense, on a Product-by-Product basis, as follows:

(a)    [***] of any upfront payment received by Kazia from each Sublicensee for a Sublicense granted prior to Initiation of Phase 2 Clinical Trial; and (b) [***] of any upfront payment received by Kazia from each Sublicensee for a Sublicense granted after Initiation of Phase 2 Clinical Trial; and

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(c)    [***] of the Development and Regulatory Milestones received by Kazia from each Sublicensee; and

(d)    [***] of the Sales Milestones received by Kazia from each Sublicensee; and

(e) [***] of any Royalties received by Kazia from each Sublicensee.

6.3.5    Payment Dates and Reports. Royalty payments shall be made by Kazia with respect to each Product within thirty (30) Business Days after the receipt of a valid tax invoice from Evotec issued following the end of each Calendar Quarter in which a sale of such Product occurs, commencing with the Calendar Quarter in which the First Commercial Sale of such Product occurs. Within 20 Business Days after the end of each Calendar Quarter, Kazia shall provide a report showing (a) the Net Sales of each Product by type of Product and country in the Territory, (b) the total amount of deductions from gross sales to determine Net Sales, (c) the applicable royalty rates for Product in each country in the Territory after applying any deductions set forth above; and (d) a calculation of the amount of royalty due to Evotec, taking into account any royalty adjustments under Sections 6.3.2, 6.3.3 and 6.3.4.

6.3.6    Records; Audit Rights. Kazia shall, and shall procure that its Affiliates and Sublicensees will, keep and maintain for three (3) years from the date of each payment of royalties hereunder complete and accurate records of gross amounts invoiced and Net Sales by Kazia and its Affiliates and Sublicensees of each Product, in sufficient detail to allow royalties to be determined accurately. Evotec shall have the right for a period of three (3) years after receiving any royalty payment under this Section 6.3 to appoint at its expense an independent certified public accountant reasonably acceptable to Kazia to audit the relevant records of Kazia and its Affiliates and Sublicensees to verify that the amount of such payment was correctly determined. Kazia shall make, and shall procure that its Affiliates and Sublicensees make, its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon thirty (30) days written notice from Evotec. Such audit right shall not be exercised by Evotec more than once in any Calendar Year or more than once with respect to sales of a particular Product in a particular period. All records made available for audit shall be deemed to be Confidential Information of Kazia. In the event that an underpayment by Kazia hereunder is identified as a result of the audit, Kazia shall promptly (but in any event no later than thirty (30) days after Kazia’s receipt of any undisputed audit report so concluding) make payment to Evotec of any shortfall.    In the event that an overpayment by Kazia hereunder is identified as a result of the audit, then Kazia may take credit for such overpayment against any future payments due to Evotec (if no future payment is due, then Evotec shall promptly refund such amount to Kazia). Evotec shall bear the full cost of any audit unless such audit discloses an underreporting by Kazia of five percent (5%) or greater of the aggregate amount of royalties payable in any Calendar Year, in which case Kazia shall reimburse Evotec for all reasonable costs incurred by Evotec in connection with such audit.

6.3.7    Overdue Payments. All payments not made by Kazia to Evotec when due under this Agreement, shall bear interest at a rate equal to 5 percent (5%) per year from the due date until paid in full or, if less, the maximum interest rate permitted by Applicable Laws. Any such overdue payment shall, when made, be accompanied by, and credited first to, all interest so accrued.

6.3.8    Tax. The royalties, milestones and other amounts payable by one Party to the other Party pursuant to this Agreement (“Payments”) shall not be reduced on account of any Taxes unless required by Applicable Law. Each Party alone shall be responsible for paying any and all Taxes (other than withholding taxes required by Applicable Law to be paid by Kazia) levied on account of, or measured in whole or in part by reference to, the income of such Party.

6.3.9    Payments; Indirect Taxes. All Payments are exclusive of Indirect Taxes. If any Indirect Taxes are chargeable in respect of any Payments, the paying Party shall pay such Indirect Taxes at the applicable rate in respect of such Payments following receipt, where applicable, of an Indirect Taxes invoice in the appropriate form issued by the receiving Party in respect of those Payments. The Parties shall issue invoices for all amounts payable under this Agreement consistent with Indirect Tax requirements and irrespective of whether the sums may be netted for settlement purposes.    If such amounts of Indirect Taxes are refunded by the applicable Regulatory Authority or other fiscal authority subsequent to payment, the Party receiving such refund shall transfer such amount to the paying Party within thirty (30) days of receipt. The Parties agree to reasonably cooperate to provide any information required by the Party pursuing a refund of Indirect Taxes paid.

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6.3.10    Withholding Tax. If Applicable Laws require withholding of income or other taxes imposed upon any payments made by Kazia to Evotec under this Agreement, Kazia shall (i) make such withholding payments as may be required, (ii) subtract such withholding payments from such payments, (iii) submit appropriate proof of payment of the withholding taxes to Evotec within a reasonable period of time, and (iv) promptly provide Evotec with all official receipts with respect thereto. Kazia shall render Evotec reasonable assistance in order to allow Evotec to obtain the benefit of any present or future treaty against double taxation which may apply to such payments.

6.3.11    Foreign Currency Exchange.    All payments to be made by Kazia to Evotec under this Agreement shall be made in Euros and shall be paid by bank wire transfer in immediately available funds to such bank account as may be designated in writing by Evotec from time to time. If, in any Calendar Quarter, Net Sales are made in any currency other than Euros, such Net Sales shall be converted into Euros as follows: (A/B), where A = foreign Net Sales in such Calendar Quarter expressed in such foreign currency; and B = the applicable foreign exchange conversion rate, expressed in local currency of the foreign country per Euro (in accordance with the rates of exchange for the relevant month for converting such other currency into Euros used by Kazia’s internal accounting systems, which are independently audited on an annual basis).

7.    TREATMENT OF CONFIDENTIAL INFORMATION; PUBLICITY

7.1     Confidentiality.

7.1.1    Confidentiality Obligations. Evotec and Kazia each recognize that the other Party’s Confidential Information and Proprietary Materials constitute highly valuable assets of such other Party. Evotec and Kazia each agrees that subject to Sections 7.1.2 and 7.1.3, during the Term and for an additional five (5) years after termination or expiration of this Agreement it shall (a) not disclose, and shall cause its Affiliates and Sublicensees not to disclose, any Confidential Information of the other Party, (b) not use, and shall cause its Affiliates and Sublicensees not to use, any Confidential Information of the other Party, except as expressly permitted in this Agreement, and (c) take all reasonable steps to ensure that any person to whom it discloses Confidential Information under Section 7.1.3 complies at all times with the terms of this Section 7 as if that Person were a Receiving Party.

7.1.2    Exceptions. The obligations of confidentiality under Section 7.1.1 do not apply to any Confidential Information that (a) as of the date of disclosure, is known to the Receiving Party or its Affiliates as demonstrated by contemporaneous credible written documentation, other than by virtue of a prior confidential disclosure to such Receiving Party, (b) as of the date of disclosure is in the public domain, or it subsequently enters the public domain through no fault of the Receiving Party, (c) it is obtained by the Receiving Party from a Third Party having a lawful right to make such disclosure free from any obligation of confidentiality to the Disclosing Party, (d) it is independently developed by or for the Receiving Party without reference to or use of any Confidential Information of the Disclosing Party as demonstrated by contemporaneous credible written documentation, or (e) is required to be disclosed as a result of Applicable Law, in which case only that information which must be disclosed in order to comply with Applicable Law should be disclosed and, where possible, the confidential nature of the disclosed information must be highlighted to the recipient of the disclosed information. Notwithstanding the foregoing, the obligations of confidentially under Section 7.1.1 shall apply to any scientific, technical, manufacturing or financial information of a Party that is disclosed at any meeting of the Parties or disclosed through an audit report. For the avoidance of doubt, any combination of Confidential Information shall not be considered in the public domain or in the possession of the Receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the Receiving Party unless the combination and its principles are in the public domain or in the possession of the Receiving Party.

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7.1.3    Limited Disclosure. Evotec and Kazia each agrees that disclosure of its Confidential Information may be made by a Receiving Party to any employee or consultant of such other Party or its Affiliates or any Third Party subcontractor engaged by a Party to enable such other Party to exercise its rights or to carry out its responsibilities under this Agreement; provided, that, any such disclosure shall only be made to Persons who are bound by written obligations of confidentiality consistent with those in this Article 7. In addition, Evotec and Kazia each agrees that a Receiving Party may disclose a Disclosing Party’s Confidential Information (a) on a need-to-know basis to the Receiving Party’s legal and financial advisors, (b) as reasonably necessary in connection with an actual or potential (i) permitted sublicense of such Receiving Party’s rights hereunder, (ii) debt or equity financing of such Receiving Party or (iii) merger, acquisition, consolidation, share exchange or other similar transaction involving such Receiving Party and any Third Party, (c) to any Third Party that is engaged by the Receiving Party to perform services in connection with the Research or Development of Products or the Commercialization of Products as necessary to enable such Third Party to perform such services, and (d) for any other purpose with the other Party’s consent, which consent shall not be unreasonably withheld. Furthermore, Evotec and Kazia each agrees that a copy of this agreement is provided to Sanofi within ten (10) days from the Effective Date. Each Party further agrees that a Receiving Party may disclose the Disclosing Party’s Confidential Information or provide the Disclosing Party’s Proprietary Materials (A) as reasonably necessary or useful to file, prosecute or maintain Patent Rights, or to file, prosecute or defend litigation related to Patent Rights, in accordance with this Agreement; (B) as reasonably necessary or useful to obtain government regulatory approval to Develop, Manufacture, transport, or Commercialize a Product; or (C) as required by Applicable Laws; provided that in the case of any disclosure under (C), the Receiving Party shall (1) if practicable, provide the Disclosing Party with reasonable advance notice of and an opportunity to comment on any such required disclosure and (2) if requested by the Disclosing Party, cooperate in all reasonable respects with the Disclosing Party’s efforts to obtain confidential treatment or a protective order with respect to any such disclosure, at the Receiving Party’s expense. The Receiving Party is liable for any breach of this Article 7 by any Person to whom it has disclosed the Disclosing Party’s Confidential Information to as if that Person were the Receiving Party in relation to the Confidential Information disclosed.

7.1.4    Employees and Consultants. Evotec and Kazia each hereby represents that all of its employees and consultants, and all of the employees and consultants of its Affiliates, who have access to Confidential Information or Proprietary Materials of the other Party are or shall, prior to having such access, be bound by written obligations to maintain such Confidential Information or Proprietary Materials in confidence. Each Party agrees to use, and to cause its Affiliates to use, reasonable efforts to enforce such obligations and to prohibit its employees and consultants from using such information except as expressly permitted hereunder. Each Party shall be liable to the other for any disclosure or misuse by its employees of Confidential Information or Proprietary Materials of the other Party.

7.2    Publicity. Each Party shall be permitted to publicly announce material developments with respect to any Licensed Product or Product, including the occurrence of any milestone event and the amount of any milestone payment under Section 6.2 and any other event with respect to a Licensed Product or Product that such Party reasonably believes is material; provided that, subject to compliance with the requirements of Applicable Laws: (i) the disclosing Party shall provide the other Party with a draft of any proposed publication at least thirty (30) days prior to the intended publication; and (ii) if any such disclosure is reasonably likely to affect the ability of the Parties to publish or present data with respect to a Licensed Product or Product or otherwise names the other Party, the disclosing Party shall obtain the other Party’s prior written consent to the content to such release, which consent shall not be unreasonably withheld, delayed or conditioned.

7.3    Publications and Presentations. Except to the extent required by Applicable Laws, the Parties shall not publish any scientific or medical publications or give other forms of similar public disclosure, such as abstracts or presentations, relating to the Licensed Product or a Product other than with the other Party’s approval (not to be unreasonably withheld). If either Party, its employees or consultants wish to make such a publication or presentation, that Party shall deliver to the other Party a copy of the proposed written publication or an outline of an oral disclosure at least thirty (30) days prior to submission for publication or presentation. Without derogating from its general approval right, the reviewing Party shall have the right to require a delay of up to ninety (90) days in publication or presentation in order to enable patent applications protecting each Party’s rights in such information to be filed and each Party shall have the right to prohibit disclosure of any of its Confidential Information in any such proposed publication or presentation. In any permitted publication or presentation by a Party, the other Party’s contribution shall be duly recognized, and co-authorship shall be determined in accordance with customary standards.

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7.4    Use of Names. Except as expressly stated in this Agreement, Kazia shall not, and shall ensure that its Affiliates and Sublicensees shall not use or register the name of Evotec and/or Sanofi (alone or as part of another name) for any purpose except with the prior written approval of, and in accordance with restrictions required by, Evotec and/or Sanofi. This restriction shall not apply to any information required by Applicable Laws to be disclosed to any Regulatory Authority.

8. LICENSE GRANTS; EXCLUSIVITY

8.1    Licenses.

8.1.1    Exclusive License Grants. Subject to the terms and conditions of this Agreement, during the Term of this Agreement, Evotec hereby grants to Kazia an exclusive license or sub-license under the Licensed Technology and the Licensed Patent Rights, including the right to grant sublicenses as provided in Section 8.2, to Research, Develop, Manufacture and Commercialize Licensed Products and Products in the Field in the Territory. Kazia hereby agrees and covenants that Kazia shall not, and will procure that its Affiliates and Sublicensees shall not, use the Licensed Technology and the Licensed Patents rights outside the scope of the license granted to Kazia under this Section 8.1.1. For purposes of clarity, the licenses granted to Kazia under this Section 8.1.1 shall be subject to the retained rights of Evotec and Sanofi solely to conduct Research (but not Development or Commercialization) with respect to Licensed Products and Products in the Field in the Territory.

8.2    Right to Sublicense.

8.2.1    Development and Manufacturing Activities. Kazia shall have the right to grant sublicenses under the licenses granted to it under Section 8.1.1 to any of its Affiliates and to any Third Party engaged by it to conduct Research, Development and Manufacturing activities subject to the same restrictions, limitations and obligations imposed upon Kazia in this Agreement.

8.2.2    Commercialization of Products. Kazia shall have the right to grant sublicenses under the licenses granted to it under Section 8.1.1 to any of its Affiliates and to any Third Party; provided that (a) it shall be a condition of any such sublicense that Kazia shall remain responsible to Evotec for the compliance of all terms of this Agreement applicable to the Commercialization of Products in the Territory by such Third Party, (b) Kazia shall provide written notice to Evotec of any such proposed sublicense agreement at least thirty (30) days prior to such execution and provide copies to Evotec of each such sublicense agreement within ten (10) days of its execution, and (c) Kazia shall not be relieved of its obligations pursuant to this Agreement as a result of such sublicense agreement.

8.3    No Other Rights. Kazia shall have no rights to use or otherwise exploit Licensed Technology or Licensed Patent Rights, except as expressly set forth in this Agreement.

8.4    Exclusivity. As from the Effective Date, and subject to the exclusive licenses granted under Section 8.1.1, Evotec shall not, independently of this Agreement, either itself or through an Affiliate or Sublicensee, initiate any Development or Commercialization activities, whether for its own account or for the benefit of any Third Party, during the Term with respect to any Licensed Product or Product or, for a period of two (2) years following the Effective Date, with respect to any product for which the primary mechanism of action relies on small molecule inhibition of vascular endothelial growth factor receptor 3 (“VEGFR3”).

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Notwithstanding anything to the contrary contained herein, Evotec shall be free to

(i) conduct screens on VEGFR3(s) hereunder if, (a) requested by a Third Party or Evotec Affiliate and (b) solely in connection with screening to determine whether a certain compound has off-target activity. By way of example, if target A is VEGFR3, and target B is a separate target, then Evotec would have the right to screen compounds that a Third Party is evaluating for use in connection with Target B in a counter-screen containing VEGFR3 solely in order to attempt to determine whether such compounds have off-target activity against VEGFR3;

(ii) conduct screens and profiling of compounds on VEGFR3 hereunder if, (a) requested by a Third Party and (b) such certain compounds are provided by the Third Party;

(iii) determine biophysical properties (Kd, Ki, kon, koff, DH, DS) as part of compound screening and profiling campaigns;

(iv) determine target protein-ligand complex structures by X-Ray crystallography and related methods if such ligands/compounds are provided by the Third Party;

(v) conduct fee for service protein, cells, probes and other reagent production, without using any gene constructs that are Kazia’s property;

(vi) conduct biomarker discovery, development and testing services on VEGFR3 and/or related biological pathway for a Third Party client of Evotec to characterize drug mechanism of action and efficacy, diagnose disease state, and stratify patients; and

(vii) conduct any development activities including IND enabling studies, CMC, formulation and API manufacture on candidate molecules as identified by a Third Party where the target might be known but is not required to perform the scope of work.

9.    INTELLECTUAL PROPERTY RIGHTS

9.1    Evotec Intellectual Property Rights. As between the Parties, Evotec shall have exclusive ownership of all right, title and interest, on a worldwide basis in and to any and all Licensed Patent Rights and Licensed Technology.

9.2    Kazia Intellectual Property Rights. As between the Parties, Kazia shall have sole and exclusive ownership of all right, title and interest on a worldwide basis in and to any and all Patent Rights and Technology owned by Kazia.

9.3    Patent Coordinators.    Each Party shall appoint a patent coordinator reasonably acceptable to the other Party (each, a “Patent Coordinator”) to serve as such Party’s primary liaison with the other Party on matters relating to patent filing, prosecution, maintenance and enforcement of Patent Rights under this Agreement. Each Party may replace its Patent Coordinator at any time by notice in writing to the other Party. Such notice becomes effective upon written acknowledgment of receipt by the other Party. The initial Patent Coordinators shall be:

For Kazia:     Dr James Garner [***]

For Evotec: [***]

9.4    Improvements. Each Party must notify the other Party of any Improvements which it or its personnel, Affiliates, Sublicensees or subcontractors discovers or develops with respect to any of the Licensed Patent Rights or Licensed Technology within sixty (60) days of discovery or development. The Parties agree that (a) all rights, title and interest in Improvements to the Licensed Patent Rights or Licensed Technology developed or discovered by or on behalf of a Party, vest in (as between the Parties) Evotec, and (b) upon discovery or development of any Improvement to the (i) Licensed Patent Rights, the Improvement will become part of the Licensed Patent Rights, and (ii) Licensed Technology, the Improvement will become part of the Licensed Technology. For the avoidance of doubt, any Improvements in and to any Patent Rights and Technology owned by Kazia will vest in Kazia.

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10. MANAGEMENT OF PATENT RIGHTS

10.1 Patent Filing, Prosecution and Maintenance.

10.1.1    Evotec Prosecution Rights. As between the Parties, Evotec, acting through patent counsel or agents of its choice, shall be responsible for the prosecution and maintenance of the Licensed Patent Rights. At Evotec’s reasonable request, Kazia shall cooperate with and assist Evotec in all reasonable respects, in connection with the preparation, filing, prosecution (including, at Kazia’s option, reviewing and commenting on draft responses to office actions from patent offices in the Territory) and maintenance of the Licensed Patent Rights. From the Effective Date, Evotec (via Sanofi, as the case may be) shall use Commercially Reasonable Efforts to prosecute and maintain composition-of-matter claims within the Licensed Patent Rights set forth on Exhibit A in the countries set forth on Exhibit B attached hereto. Evotec shall be free, at is sole discretion and at any time upon ninety (90) days prior written notice to Kazia, to abandon any Licensed Patent Rights, provided that Evotec shall not abandon any of the Licensed Patent Rights set forth on Exhibit A in the countries set forth on Exhibit B that Cover a Licensed Product being Researched, Developed or Commercialized by Kazia hereunder after the Effective Date. Any Licensed Patent Rights set forth on Exhibit A in other countries than those countries set forth on Exhibit B that Cover a Licensed Product being Researched, Developed or Commercialized by Kazia hereunder may only be abandoned by Evotec with Kazia’s prior written consent, which consent shall not be unreasonably withheld, in which case Kazia shall have the right (but no obligation) to continue to prosecute and maintain such Licensed Patent Rights, in Evotec’s and/or Sanofi’s name and at Kazia’s cost and expense, acting through patent counsel or agents of its choice.

10.1.2    Kazia Prosecution Option. Evotec must promptly notify Kazia in writing of any decision it makes to abandon any Licensed Patent Rights. In such event, upon Kazia’s request, Evotec shall use best endeavours to transfer the right to file, prosecute and maintain such Licensed Patent Rights to Kazia and Kazia shall have the right to continue filing, prosecution and / or maintenance of such Licensed Patents Rights at Kazia’s own expense.

10.1.3    Patent Costs. Prior to incurring any Patent Costs, Evotec must obtain Kazia’s prior written consent, which consent shall not be unreasonably withheld or delayed. If Kazia consents to any Patent Costs being incurred, such Patent Costs shall be borne by Kazia. If Kazia does not consent to Patent Costs being incurred, Kazia will not be responsible for such Patent Costs, in which case (i) Evotec may continue to prosecute and maintain the applicable Licensed Patent Rights solely at its cost and expense or (ii) Evotec may elect to cease such prosecution and maintenance, in which case Kazia shall have the right (but no obligation) to continue to prosecute and maintain such Licensed Patent Rights, in Evotec’s and/or Sanofi’s name and at Kazia’s sole cost and expense, acting through patent counsel or agents of its choice.

10.1.4    Kazia Prosecution Rights. Kazia, at its sole expense and acting through patent counsel or agents of its choice, shall be responsible for the preparation, filing, prosecution and maintenance of all Patent Rights owned by Kazia. At Kazia’s request and cost, Evotec shall cooperate with and assist Kazia in all reasonable respects, in connection with Kazia’s preparation, filing, prosecution and maintenance of such Patent Rights.

10.1.5    National Registration of Exclusive License. Kazia shall at is sole discretion be responsible for, and shall support all costs relating to, the filing of the exclusive licenses granted hereunder with any national patent register in the Territory as is required by Applicable Law.

10.2 Enforcement and Defense.

[***]

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10.3    Patent Term Extension. The Parties shall cooperate with each other in obtaining patent term extensions or supplemental protection certificates or their equivalents in any country in the Territory where applicable to Licensed Patent Rights. Such cooperation shall include diligently and timely conferring and coordinating with respect to such matters to ensure compliance with applicable filing deadlines, and agreeing on procedures to be followed by the Parties to ensure such compliance. In the event that elections with respect to obtaining such patent term extension are to be made with respect to a Product, Kazia shall have the right to make the election with respect to Licensed Patent Rights. All costs and expenses reasonably incurred by either Party in connection with obtaining and maintaining such patent term extension shall be paid by Kazia.

11. TERM AND TERMINATION

11.1    Term. This Agreement shall commence on the Effective Date and shall continue in full force and effect, unless otherwise terminated pursuant to Section 11.2, until the expiration of all payment obligations under this Agreement with respect to Products in all countries in the Territory (the “Term”). Upon the expiration of this Agreement as set forth in this Section 11.1, the license rights granted under Section 8.1.1 and 8.2 shall be converted to perpetual and fully paid-up non-exclusive licenses.

11.2    Termination. This Agreement may be terminated by either Party as follows:

11.2.1    Unilateral Right to Terminate Agreement.

(a)    Kazia Right to Terminate Agreement. Kazia may terminate this Agreement effective immediately at any time after the third (3^rd) anniversary of the Effective Date.

(b)    Evotec Rights to Terminate. Except to the extent the following is unenforceable under the law of a particular jurisdiction where a patent application within the Licensed Patent Rights is pending or a patent within the Licensed Patent Rights is issued, Evotec may terminate this Agreement immediately upon written notice to Kazia in the event that (i) Kazia or any of its Affiliates, Sublicensees or Distributors Challenges any Licensed Patent Rights or assists a Third Party in initiating a Challenge of any Licensed Patent Rights; or (ii) the Sanofi License terminates.

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11.2.2    Termination for Breach. If a Party materially breaches any of its obligations under the Agreement, the non-breaching Party may provide the breaching Party with a written notice specifying the nature of the breach, and stating its intention to terminate this Agreement if such breach is not cured. If the material breach is not cured within ninety (90) days after the receipt of such notice, the non- breaching Party shall be entitled, without prejudice to any of its other rights under this Agreement, and in addition to any other remedies available to it by law or in equity, to terminate this Agreement by providing written notice to the other Party.

11.2.3    Termination for Insolvency. To the extent permitted by Applicable Law, if either Party makes an assignment for the benefit of creditors, appoints or suffers appointment of a receiver or trustee over all or substantially all of its property, files a petition under any bankruptcy or insolvency act or has any such petition filed against it which is not discharged within sixty (60) days of the filing thereof, the other Party may terminate this Agreement effective immediately upon written notice to such Party.

11.3    Consequences of Termination of Agreement. If this Agreement is terminated pursuant to Section 11.2, the following provisions shall apply, as applicable.

11.3.1    Termination by Evotec under 11.2.1(b), 11.2.2 or 11.2.3 or by Kazia under Section 11.2.1(a):

(a)    If this Agreement is terminated by Kazia pursuant to Section 11.2.1(a) or by Evotec pursuant to Section 11.2.1(b), 11.2.2 or 11.2.3, all licenses and rights granted pursuant to this Agreement shall immediately terminate.

(b)    If this Agreement is terminated by Kazia pursuant to Section 11.2.1(a) or by Evotec pursuant to Section 11.2.1(b)(i), 11.2.2 or 11.2.3, Kazia shall and hereby does grant to Evotec an option to obtain (i) an exclusive license to all Patent Rights and (ii) an non-exclusive license to all Technology; in each case (i) and (ii) owned or Controlled by Kazia and required to research, develop, have developed, make, have made, use, distribute for sale, sell, offer for sale, import and have imported Licensed Products and Products for use in the Field (“Termination License”). If Evotec - at its sole discretion - exercises the option to obtain the Termination License, the Termination License will be royalty bearing, with the royalty payment for the Termination License calculated at the following rates:

(i)    If Evotec - at its sole discretion - exercises the option to obtain the Termination License and Kazia has not completed the Phase 1 Clinical Trial for the relevant Licensed Products or Products that is subject to the Termination License, the Termination License shall be royalty- free.

(ii)    If Evotec - at its sole discretion - exercises the option to obtain the Termination License and Kazia has completed the Phase 1 Clinical Trial but not the Phase 2 Clinical Trial for the relevant Licensed Products or Products that is subject to the Termination License, the Termination License shall be subject to royalty payment for the Termination License calculated at the following rates.

Annual Net Sales of Licensed Products or Products	Royalty Rate (%)
[***][***][***][***]
[***][***][***][***]

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(iii)    If Evotec - at its sole discretion - exercises the option to obtain the Termination License and Kazia has completed the Phase 2 Clinical Trial for the relevant Licensed Products or Products that is subject to the Termination License, the Termination License shall be subject to royalty payment for the Termination License calculated at the following rates.

Annual Net Sales of Licensed Products or Products	Royalty Rate (%)
[***]		[	***]
[***]		[	***]
[***]		[	***]
[***]		[	***]

The royalty term for such reverse royalties per these Sections 12.3.1 (b) (ii) and (iii) shall be, with respect to each Product in each country of the Territory, the period beginning on the date of First Commercial Sale of such Product in such country [***].

(c)    If this Agreement is terminated by Kazia pursuant to Section 11.2.1(a) or by Evotec pursuant to Section 11.2.1(b)(i), 11.2.2 or 11.2.3, upon Evotec’s request Kazia shall, where permitted under Applicable Laws, use Commercially Reasonable Efforts to transfer to Evotec all Regulatory Approvals held by Kazia with respect to such Products within thirty (30) Business Days after the effective date of the termination. All transfers described in this Section 11.3.1(c) shall be at Kazia’s expense in cases of termination by Evotec pursuant to Section 11.2.1(b)(i), 11.2.2 or 11.2.3; and at Evotec’s expense in cases of termination by Kazia pursuant to Section 11.2.1(a).

(d)    If this Agreement is terminated by Kazia pursuant to Section 11.2.1(a) or by Evotec pursuant to Section 11.2.1(b), 11.2.2 or 11.2.3, each Party shall promptly cease use of and return all Confidential Information and Proprietary Materials of the other Party that are not subject to a continuing license hereunder; provided that each Party may retain one copy of the Confidential Information of the other Party in its archives solely for the purpose of establishing the contents thereof and ensuring compliance with its obligations hereunder.

(e)    If the notice of the termination by Kazia under 11.2.1(a) is given at a time when any Clinical Trials have been initiated but not yet completed, then the Parties shall work together in good faith during the termination notice period to ensure that Kazia’s involvement in and responsibilities for such activities shall be discontinued and ceased as efficiently and promptly as possible (by way of transitioning such involvement and responsibilities to Evotec or by other means agreed to by the Parties), subject to Applicable Laws, including GCP.

(f)    If this Agreement is terminated by Kazia pursuant to Section 11.2.1(a) or by Evotec pursuant to Section 11.2.1(b), 11.2.2 or 11.2.3, all sublicense agreements between Kazia and its Affiliates or Sublicensees, shall terminate as of the effective date of the termination, unless Evotec provides written consent, which it shall not unreasonably withhold, delay or condition, to the assignment of any such sublicense agreement, or license agreement, as the case may be, to Evotec (to the extent assignable).

(g)    If this Agreement is terminated by Kazia pursuant to Section 11.2.1(a) or by Evotec pursuant to Section 11.2.1(b), 11.2.2 or 11.2.3, any continuing reporting obligations of Kazia shall be verified exclusively through a Third Party to be mutually agreed, and Evotec shall not have direct access anymore to Kazia’s Confidential Information.

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11.3.2    Termination by Kazia. If this Agreement is terminated by Kazia pursuant to Section 11.2.2 or 11.2.3:

(a)    Subject to the Sanofi License remaining in force, all licenses and rights granted by Evotec to Kazia pursuant to this Agreement, including, all licenses granted to Kazia under Section 8.1.1, survive the termination in each case subject to Kazia’s continued payment of all milestone, royalty and other payments under and in accordance with this Agreement with respect thereto; provided that, in case this Agreement is terminated by Kazia pursuant to Section 11.2.2, Kazia shall have the right to reduce any such payment by half;

(b)    All licenses and rights granted by Kazia to Evotec pursuant to this Agreement terminate; and

(c)    Each Party shall promptly cease use of and return all Confidential Information and Proprietary Materials of the other Party that are not subject to a continuing license hereunder; provided that each Party may retain one copy of the Confidential Information of the other Party in its archives solely for the purpose of establishing the contents thereof and ensuring compliance with its obligations hereunder.

11.4    Surviving Provisions. Termination or expiration of this Agreement for any reason shall be without prejudice to: (a) the survival of rights specifically stated in this Agreement to survive, including as set forth in Section 11.3; (b) the rights and obligations of the Parties provided in the following Sections: Section 6.3.6 (for a period of three (3) years, as provided therein); Article 7 (for a period of five (5) years, as provided in Section 7.1.1); this Section 11.4; and Article 1, Article 13, and Article 14 (including all other Sections or Articles referenced in any such Section or Article), all of which shall survive such termination except as provided in this Article 11; and (c) any other rights or remedies provided at law or equity which either Party may otherwise have.

12. REPRESENTATIONS, WARRANTIES AND COVENANTS

12.1    Mutual Representations and Warranties. Evotec and Kazia each represents and warrants to the other, as of the Effective Date, as follows:

12.1.1    Organization. It is a corporation duly organized, validly existing and in good standing under the laws of the jurisdiction of its organization, and has all requisite power and authority, corporate or otherwise, to execute, deliver and perform this Agreement.

12.1.2    Authorization. The execution and delivery of this Agreement and the performance by it of the transactions contemplated hereby have been duly authorized by all necessary corporate action and shall not violate (a) such Party’s certificate of incorporation or bylaws, (b) any agreement, instrument or contractual obligation to which such Party is bound in any material respect, (c) any requirement of any Applicable Laws, or (d) any order, writ, judgment, injunction, decree, determination or award of any court or governmental agency presently in effect applicable to such Party.

12.1.3    Binding Agreement. This Agreement is a legal, valid and binding obligation of such Party, enforceable against it in accordance with its terms and conditions.

12.1.4    No Inconsistent Obligation. It is not under any contractual obligation to any Person that conflicts with or is inconsistent in any respect with the terms of this Agreement or that would materially impede the diligent and complete fulfillment of its obligations hereunder.

12.2    Additional Representations of Evotec. Evotec further represents and warrants to Kazia as follows:

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12.2.1    Licensed Patent Rights. Except as expressly disclosed in Exhibit A, as at the Effective Date, the Licensed Patent Rights set forth on Exhibit A (i) are Controlled by Evotec, (ii) represent the complete and accurate (in all material respects) list of all Licensed Patent Rights Controlled by Evotec that relate to the Licensed Product; and (iii) to Evotec´s Knowledge have been filed in accordance with the requirements of the applicable patent office, prosecuted with Commercially Reasonable Efforts and are not lapsed or abandoned. To Evotec’s Knowledge, it has the ability to grant to Kazia the rights and licenses granted to Kazia under the Licensed Patents. Kazia hereby acknowledges that the certain Licensed Patent Rights is either owned by Sanofi or jointly owned by Evotec and Sanofi.

12.2.2    No Claims. As at the Effective Date, there are no claims, judgment or settlements against Evotec pending, or to Evotec’s Knowledge, threatened in writing (including email), that invalidate or seek to invalidate the Licensed Patent Rights.

12.2.3    No Infringement or Misappropriation. To Evotec’s Knowledge, as at the Effective Date, Evotec and its Affiliates have not infringed or misappropriated any intellectual property of any Third Party during its Research, Development, Manufacture or Commercialization of the Licensed Product or any Products. Evotec and its Affiliates have not received any notice from any Third Party asserting or alleging any such infringement.

12.2.4    Compliance with Applicable Laws. To Evotec’s Knowledge, as at the Effective Date, Evotec and its Affiliates have complied with all Applicable Laws in connection with the Research, Development, and Manufacture of the Licensed Product.

12.2.5    Information. The information provided to Kazia by or on behalf of Evotec in relation to the Licensed Product, Licensed Patent Rights or the Licensed Technology is complete, true and accurate and all the information that Kazia could reasonably require in order to understand and appreciate the composition and status of these items.

12.2.6    No Conflicting Rights. Except for the Sanofi License, as at the Effective Date and on each day during the Term, there is no agreement between Evotec or its Affiliates and any Third Party pursuant to which Evotec or its Affiliates obtained any right or license to the Licensed Product or Product or any intellectual property rights related to the Licensed Product or Product. Evotec has not granted any right, license or interest under the Licensed Patent Rights or the Licensed Technology that is inconsistent with the licenses granted to Kazia under this Agreement.

12.2.7    Licensed Technology. The Licensed Technology set forth in Exhibit A represents the complete and accurate (in all material respects) list of all Technology Controlled or in-licensed by Evotec or its Affiliates at the Effective Date which is reasonably required by Kazia for Research, Development, Manufacture or Commercialization of the Licensed Product or Products. Evotec has the ability to grant to Kazia the rights and sub-licenses granted to Kazia under the Licensed Technology. Kazia hereby acknowledges that the certain Licensed Technology is either owned by Sanofi or jointly owned by Evotec and Sanofi.

12.2.8    Sanofi License. As at the Effective Date, no written notice of default or termination has been received or given under the Sanofi License and there is no act or omission by Evotec that would give rise to a right to terminate the Sanofi License. During the Term, Evotec will, at its own cost and expense, use best efforts to maintain the Sanofi License in full force and effect.    In the event of any breach of the Sanofi License by Evotec, Evotec shall immediately notify Kazia in writing. If Evotec fails to cure such breach in a timely manner, Kazia shall have the right (but not the obligation) to support Evotec to cure such breach and to offset any reasonable amount incurred or paid by Kazia in connection with the cure against the amount payable to Evotec under this Agreement. Evotec shall not terminate the Sanofi License without first obtaining Kazia’s prior written consent, which consent shall not be unreasonably withheld. If, despite Evotec’s best efforts, the Sanofi License is terminated, Evotec shall use best efforts to assist Kazia to obtain a direct license from Sanofi.

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12.2.9    [***].

12.3    Additional Representations of Kazia.    Kazia further represents and warrants to Evotec as of the Effective Date, as follows:

12.3.1    No Debarment. Neither Kazia nor any of its Affiliates has been debarred or is subject to debarment pursuant to Section 306 (or comparable law or regulation) of the USFDA. During the Term, Kazia and its Affiliates shall use Commercially Reasonable Efforts to avoid using in any capacity, in connection with the Research or Development of any Licensed Product or Product, or the Manufacture or Commercialization of any Product, any Person who to Kazia’s Knowledge has been debarred pursuant to Section 306 (or comparable law or regulation) of the USFDA, or who, to Kazia’s Knowledge, is the subject of a conviction described in such section. Kazia agrees to inform Evotec in writing if it or any Person who is performing services hereunder is debarred or is the subject of a conviction described in Section 306 (or comparable law or regulation), or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to Kazia’s knowledge, is threatened, relating to the debarment or conviction of Kazia or any Person used in any capacity by Kazia or any of its Affiliates in connection with the Research or Development of any Licensed Product or Product, or the Manufacture or Commercialization of any Product.

12.4    Warranty Disclaimer. TO THE EXTENT PERMITTED BY LAW, EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY WARRANTY WITH RESPECT TO ANY KNOW-HOW, GOODS, SERVICES, RIGHTS OR OTHER SUBJECT MATTER OF THIS AGREEMENT AND EACH PARTY HEREBY DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. WITHOUT LIMITING THE FOREGOING AND EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, EVOTEC MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND WITH RESPECT TO (A) OWNERSHIP OF INTELLECTUAL PROPERTY RELATED TO COMPOUNDS, OR PRODUCTS, OR (B) NONINFRINGEMENT OR MISAPPROPRIATION OF ANY THIRD PARTY INTELLECTUAL PROPERTY RIGHTS.

13.    INDEMNIFICATION; INSURANCE

13.1    [***]

13.2    [***]

13.3    [***]

13.4    Insurance. Not later than thirty (30) days before the date on which Kazia or any Affiliate, Sublicensee or Distributor of Kazia shall, on a commercial basis, Commercialize or Manufacture any Products, and at all times thereafter until the expiration of (a) all applicable statutes of limitation pertaining to any such Commercialization or Manufacture of any Products or (b) where the applicable statute of limitation is unknown, five (5) years following the expiration or termination of this Agreement, Kazia shall, at its expense, with respect to Products, obtain and maintain in full force and effect, comprehensive general liability insurance, with a minimum coverage of [***] per occurrence and [***] annual aggregate. Such commercial general liability insurance shall provide: (a) product liability coverage and (b) broad form contractual liability coverage for Kazia’s indemnification obligations under this Agreement. Kazia shall provide Evotec with written notice at least fifteen (15) days prior to the cancellation, non-renewal or material change in such insurance and shall obtain replacement insurance providing comparable coverage within such fifteen (15) day period.

13.5    [***]

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13.6    Personal Injury. Nothing in this Agreement operates to exclude or restrict a Party’s liability for (a) its gross negligence, intentional misconduct or fraud, or (b) for personal injury or death.

14.    MISCELLANEOUS

14.1    Notices. All notices and communications shall be in writing and delivered by email to the email address below or personally or by internationally-recognized express courier providing evidence of delivery or mailed via certified mail, return receipt requested, addressed as follows, or to such other address as may be designated from time to time:

If to Evotec:	Evotec (France) SAS
	195 route d’Espagne
	31036 Toulouse Cedex
	France
	Attention: General Counsel
	[***]
If to Kazia:	Kazia Therapeutics Limited
	L24, 300 Barangaroo Avenue
	Sydney, NSW 2000
	Australia
	Attn: Chief Executive Officer
	[***]
With a copy to:	K&L Gates
	L25, 525 Collins Street
	Melbourne, VIC 3000
	Australia
	[***]

Except as otherwise expressly provided in this Agreement or mutually agreed by the Parties in writing, any notice, communication or document (excluding payment) required to be given or made shall be deemed given or made and effective upon actual receipt or, if earlier, (a) three (3) Business Days after deposit with an internationally-recognized express courier with charges prepaid, (b) seven (7) Business Days after mailed by certified, registered or regular mail, postage prepaid, or (c) if sent by email, two (2) hours after the time the email is sent to the recipient’s email address, as recorded on the sender’s email system, unless the sender receives within that time period, an automatic notification (other than an out of office message) indicating that the email has not been delivered, in each case addressed to a Party at its address stated above or to such other address as such Party may designate by written notice given in accordance with this Section 14.1.

14.2    Governing Law.    This Agreement shall be governed by and construed in accordance with the laws of New York State, United States of America, without regard to the application of principles of conflicts of law.

14.3    Dispute Resolution.

14.3.1    Referral of Disputes. In the event of any dispute between the Parties arising out of or in connection with this Agreement (“Dispute”), either Party may, provide a written notice (“Dispute Notice”) to the other which sets out the nature of the Dispute and the relief or remedy that the Party seeks.

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14.3.2    Negotiation by Parties’ Senior Executives. During the period thirty (30) days after delivery of the Dispute Notice, or any longer period agreed in writing by the Parties (“Initial Period”), the senior executives of each Party must use their reasonable endeavours and act in good faith to resolve the Dispute by discussion and negotiation.

14.3.3    Referral to Arbitration. If the Dispute is not resolved within the Initial Period, then the Dispute must be resolved by arbitration administered by the American Arbitration Association in accordance with the Commercial Arbitration Rules which are operating at the time the Dispute is referred to arbitration. Judgment on the award rendered by the arbitrator(s) may be entered in any court having jurisdiction thereof.

14.3.4    Conduct of Arbitration. The arbitration shall be conducted by a single arbitrator mutually agreed by the Parties within thirty (30) days after initiation of arbitration. If the Parties are unable or fail to agree upon the arbitrator, the arbitrator shall be appointed by the American Arbitration Association. The seat of arbitration must be New York State and the language of arbitration must be English.

14.3.5    Other Proceedings. Subject to Section 14.3.7, no Party may commence any judicial proceedings in relation to the Dispute unless those proceedings are commenced for the purpose of enforcing this Section 14.3 or to seek interlocutory relief during the Initial Period.

14.3.6    Costs. The “prevailing” Party, as determined by the arbitrator, shall be entitled to its share of reasonable attorney fees associated with the arbitration.    If the arbitrator determines that, given the scope of the arbitration, neither Party “prevailed”, the arbitrator shall order that the Parties (a) share equally the arbitrators’ fees and any administrative fees of arbitration, and (b) bear their own attorneys’ fees and associated costs and expenses.

14.3.7    Intellectual Property Disputes. Notwithstanding anything to the contrary, any and all issues regarding the scope, inventorship, construction, validity, enforceability or ownership of any Patent Rights hereunder shall be determined in a court of competent jurisdiction under the local patent laws of the jurisdictions having issued the Patent Rights in question.

14.3.8    Jurisdiction. Subject to this Section 14.3, the Parties submit to the exclusive jurisdiction of the courts of New York State, United States of America, in respect of any dispute, controversy or claim arising out of or relating to this Agreement, including the existence, negotiation, validity, formation, interpretation, breach, performance or application of this Agreement.

14.4    Binding Effect. This Agreement shall be binding upon and inure to the benefit of the Parties and their respective legal representatives, successors and permitted assigns.

14.5    Headings. Section and subsection headings are inserted for convenience of reference only and do not form a part of this Agreement.

14.6    Counterparts. This Agreement may be executed simultaneously in two or more counterparts, each of which shall be deemed an original and both of which, together, shall constitute a single agreement.

14.7    Amendment; Waiver. This Agreement may be amended, modified, superseded or canceled, and any of the terms of this Agreement may be waived, only by a written instrument executed by each Party or, in the case of waiver, by the Party or Parties waiving compliance. The delay or failure of either Party at any time or times to require performance of any provisions shall in no manner affect the rights at a later time to enforce the same. No waiver by either Party of any condition or of the breach of any term contained in this Agreement, whether by conduct, or otherwise, in any one or more instances, shall be deemed to be, or considered as, a further or continuing waiver of any such condition or of the breach of such term or any other term of this Agreement.

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14.8    No Partnership. Nothing in this Agreement shall be construed (a) to create or imply a general partnership between the Parties, (b) to make either Party the agent of the other for any purpose, (c) to alter, amend, supersede or vitiate any other arrangements between the Parties with respect to any subject matters not covered hereunder, (d) to give either Party the right to bind the other, (e) to create any duties or obligations between the Parties except as expressly set forth herein, or (f) to grant any direct or implied licenses or any other right other than as expressly set forth herein.

14.9    Assignment and Successors. Neither this Agreement nor any obligation of a Party hereunder may be assigned by either Party without the consent of the other which shall not be unreasonably withheld, except that each Party may assign this Agreement and the rights, obligations and interests of such Party, (a) in whole or in part, to any of its Affiliates, or (b) in whole, but not in part, to any purchaser of all of its assets or all of its assets to which this Agreement relates or shares representing a majority of its common stock voting rights or to any successor corporation resulting from any merger, consolidation, share exchange or other similar transaction.

14.10    Force Majeure. Neither Kazia nor Evotec shall be liable for failure of or delay in performing obligations set forth in this Agreement, and neither shall be deemed in breach of its obligations, if such failure or delay is due to a Force Majeure. In event of such Force Majeure, the Party affected shall use reasonable efforts to cure or overcome the same and resume performance of its obligations hereunder.

14.11    Interpretation. The Parties hereto acknowledge and agree that: (a) each Party and its counsel reviewed and negotiated the terms and provisions of this Agreement and have contributed to its revision; (b) the rule of construction to the effect that any ambiguities are resolved against the drafting Party shall not be employed in the interpretation of this Agreement; and (c) the terms and provisions of this Agreement shall be construed fairly as to each Party and not in a favor of or against either Party, regardless of which Party was generally responsible for the preparation of this Agreement. In addition, unless a context otherwise requires, wherever used, the singular shall include the plural, the plural the singular, the use of any gender shall be applicable to all genders, the word “or” is used in the inclusive sense (and/or) and the word “including” is used without limitation and means “including without limitation”.

14.12    Integration; Severability. This Agreement (including the Exhibits attached hereto) sets forth the entire agreement with respect to the subject matter hereof and thereof and supersedes all other agreements and understandings between the Parties with respect to such subject matter. If any provision of this Agreement is or becomes invalid or is ruled invalid by any court of competent jurisdiction or is deemed unenforceable, it is the intention of the Parties that the remainder of the Agreement shall not be affected. In the event of any conflict or inconsistency between the text of this Agreement and the attached Exhibits, the text of this Agreement shall control.

14.13    Further Assurances. Each of Evotec and Kazia agrees to duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such additional assignments, agreements, documents and instruments, as the other Party may at any time and from time to time reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes of, or to better assure and confirm unto such other Party its rights and remedies under, this Agreement.

[Signature page follows]

28

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized representatives.

Executed by Evotec (France) SAS:

/s/ Craig Johnstone	/s/ Christian Dargel
Signature of director	Signature of director or company secretary*
	*delete whichever does not apply
Craig Johnstone	Christian Dargel
Name (please print)	Name (please print)

Executed by Kazia Therapeutics, Ltd. ACN 063 259 754 in accordance with section 127(1) of the Corporations Act 2001 (Cth):

/s/ James Garner	/s/ Kate Hill
Signature of director	Signature of director or company secretary*
	*delete whichever does not apply
James Garner	Kate Hill            Company Secretary
Name (please print)	Name (please print)

29

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EX-12.1

Exhibit 12.1

Certification of the Chief Executive Officer as required by

Rule 13a-14(a) of the Securities Exchange Act of 1934

I, James Garner, certify that:

1. I have reviewed this Annual Report on Form 20-F for the fiscal year ended June 30, 2021 (‘Report’) of Kazia Therapeutics Limited (the ‘Company’);

2. Based on my knowledge, this Report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this Report;

3. Based on my knowledge, the financial statements, and other financial information included in this Report, fairly present in all material respects the financial condition, results of operations and cash flows of the Company as of, and for, the periods presented in this Report;

4. The Company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e) ) and internal control over financial reporting (as defined in the Exchange Act Rules 13a-15(f) and 15d-15(f) for the Company and have:

(a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) evaluated the effectiveness of the Company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) disclosed in this report any change in the Company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect the Company’s internal control over financial reporting; and

5. The Company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Company’s auditors and the audit committee of the Company’s Board of Directors (or persons performing the equivalent functions).

(a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Company’s ability to record, process, summarize and report financial information; and

(b) any fraud, whether or not material, that involves management or other employees who have a significant role in the Company’s internal control over financial reporting.

/s/ James Garner

James Garner

Chief Executive Officer

Date: October 7, 2021

EX-12.2

Exhibit 12.2

Certification of the Director of Finance and Administration as required by

Rule 13a-14(a) of the Securities Exchange Act of 1934

I, Gabrielle Heaton, certify that:

1. I have reviewed this Annual Report on Form 20-F for the fiscal year ended June 30, 2021 (‘Report’) of Kazia Therapeutics Limited (the ‘Company’);

2. Based on my knowledge, this Report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this Report;

3. Based on my knowledge, the financial statements, and other financial information included in this Report, fairly present in all material respects the financial condition, results of operations and cash flows of the Company as of, and for, the periods presented in this Report;

4. The Company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e) ) and internal control over financial reporting (as defined in the Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Company and have:

(a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) evaluated the effectiveness of the Company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) disclosed in this report any change in the Company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect the Company’s internal control over financial reporting; and

5. The Company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Company’s auditors and the audit committee of the Company’s Board of Directors (or persons performing the equivalent functions).

(a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Company’s ability to record, process, summarize and report financial information; and

(b) any fraud, whether or not material, that involves management or other employees who have a significant role in the Company’s internal control over financial reporting.

/s/ Gabrielle Heaton

Gabrielle Heaton

Director of Finance and Administration

Date: October 7, 2021

EX-13.1

Exhibit 13.1

Certification of the Chief Executive Officer and the Director of Finance and Administration as required by Rule 13a-14(b) of the Securities Exchange Act of 1934

Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), James Garner, Chief Executive Officer, and Gabrielle Heaton, Director of Finance and Administration, of Kazia Therapeutics Limited, an Australian corporation (the ‘Company’), hereby certifies that:

(1) The Company’s periodic report on Form 20-F for the period ended June 30, 2021 (the ‘Form 20-F’) fully complies with the requirements of section 13(a) or Section 15(d) of the Securities Exchange Act of 1934 as amended; and

(2) The information contained in the Form 20-F fairly presents, in all material respects, the financial condition and results of operations of the Company.

*        *        *

Chief Executive Officer	Director of Finance and Administration
/s/ James Garner	/s/ Gabrielle Heaton
James Garner	Gabrielle Heaton
Date: October 7, 2021	Date: October 7, 2021

This certification accompanies the Form 20-F to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Kazia Therapeutics Limited under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 20-F), irrespective of any general incorporation language contained in such filing.

A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

EX-15.1

Exhibit 15.1

Consent of Independent Registered Public Accounting Firm

We have issued our report dated October 7, 2021 with respect to the consolidated financial statements included in the Annual Report of Kazia Therapeutics Limited on Form 20-F for the year ended June 30, 2021.

We consent to the incorporation by reference of the said report in the Registration Statement of Kazia Therapeutics Limited on Form F-3 (File No. 333-259224).

/s/ Grant Thornton Audit Pty Ltd

GRANT THORNTON AUDIT PTY LTD

Sydney, Australia

October 7, 2021

XML

Cover	12 Months Ended
	Jun. 30, 2021 shares
Document Information [Line Items]
Document Type	20-F
Amendment Flag	false
Document Period End Date	Jun. 30, 2021
Document Fiscal Year Focus	2021
Document Fiscal Period Focus	FY
Entity Registrant Name	Kazia Therapeutics Limited
Entity Central Index Key	0001075880
Current Fiscal Year End Date	--06-30
Entity Well-known Seasoned Issuer	No
Entity Current Reporting Status	Yes
Entity Filer Category	Non-accelerated Filer
Entity Emerging Growth Company	false
Entity Voluntary Filers	No
Entity Shell Company	false
Entity Interactive Data Current	Yes
Document Transition Report	false
Document Annual Report	true
Document Shell Company Report	false
Entity Address, Address Line One	Three International Towers Level 24, 300 Barangaroo Avenue
Entity Address, City or Town	Sydney
Entity Address, Postal Zip Code	2000
Entity Address Country	AU
Document Registration Statement	false
Document Accounting Standard	International Financial Reporting Standards
Entity Common Stock, Shares Outstanding	132,012,209
Entity Incorporation, State or Country Code	C3
Entity File Number	0-29962
Title of 12(b) Security	American Depositary Shares, each representing ten Ordinary Shares*
Trading Symbol	KZIA
Security Exchange Name	NASDAQ
ICFR Auditor Attestation Flag	false
Business Contact [Member]
Document Information [Line Items]
Contact Personnel Name	Gabrielle Heaton
Contact Personnel Email Address	Gabrielle.Heaton@kaziatherapeutics.com
Entity Address, Address Line One	Three International Towers Level 24, 300 Barangaroo Avenue
Entity Address, City or Town	Sydney
Entity Address, Postal Zip Code	2000
Entity Address Country	AU
Country Region	61
City Area Code	2
Local Phone Number	9472-4101

XML

Consolidated statements of profit or loss and other comprehensive income - AUD ($)	12 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2019
Profit or loss [abstract]
Revenue from continuing operations	$ 15,183,000
Other income	2,000	$ 995,000	$ 1,465,000
Finance income - bank interest	42,000	66,000	100,000
Expenses
Research and development expense	(14,541,000)	(9,494,000)	(6,475,000)
General and administrative expense	(7,022,000)	(3,690,000)	(3,785,000)
Loss on disposal of fixed assets			(1,000)
Fair value losses on financial assets at fair value through profit or loss	0	(168,000)	(1,809,000)
Loss on revaluation of contingent consideration	(2,570,000)	(474,000)	(63,000)
Loss before income tax expense from continuing operations	(8,906,000)	(12,765,000)	(10,568,000)
Income tax benefit	484,000	298,000	298,000
Loss after income tax expense for the year	(8,421,960)	(12,467,466)	(10,270,000)
Items that may be reclassified subsequently to profit or loss
Net exchange difference on translation of financial statements of foreign controlled entities, net of tax	2,000	(4,000)	(89,000)
Other comprehensive income for the year, net of tax	2,000	(4,000)	(89,000)
Total comprehensive income for the year	(8,420,000)	(12,471,000)	(10,359,000)
Loss for the year is attributable to:
Owners of Kazia Therapeutics Limited	(8,422,000)	(12,467,000)	(10,270,000)
Loss after income tax expense for the year	(8,421,960)	(12,467,466)	(10,270,000)
Total comprehensive income for the year is attributable to:
Owners of Kazia Therapeutics Limited	(8,420,000)	(12,471,000)	(10,359,000)
Total comprehensive income for the year	$ (8,420,000)	$ (12,471,000)	$ (10,359,000)
Earnings per share for loss from continuing operations attributable to the owners of Kazia Therapeutics Limited
Basic earnings per share	$ (7.16)	$ (17.07)	$ (17.86)
Diluted earnings per share	(7.16)	(17.07)	(17.86)
Earnings per share for loss attributable to the owners of Kazia Therapeutics Limited
Basic earnings per share	(7.16)	(17.07)	(17.86)
Diluted earnings per share	$ (7.16)	$ (17.07)	$ (17.86)

XML

Consolidated statements of financial position - AUD ($)	Jun. 30, 2021	Jun. 30, 2020
Current assets
Cash and cash equivalents	$ 27,586,760	$ 8,764,044
Trade and other receivables	84,000	1,352,000
Other	1,720,000	537,000
Total current assets	29,391,000	10,653,000
Non-current assets
Trade and other receivables	6,694,000
Intangibles	22,003,000	12,410,000
Total non-current assets	28,697,000	12,410,000
Total assets	58,088,000	23,063,000
Current liabilities
Trade and other payables	4,933,000	3,489,000
Employee benefits	229,000	191,000
Contingent consideration	3,165,000	1,387,000
Total current liabilities	8,327,000	5,067,000
Non-Current liabilities
Deferred tax	2,928,000	3,413,000
Employee benefits	55,000
Contingent consideration	8,927,000	458,000
Total non-current liabilities	11,910,000	3,871,000
Total liabilities	20,237,000	8,938,000
Net assets	37,851,000	14,125,000
Equity
Contributed equity	80,290,062	48,781,214
Other contributed equity	464,000	464,000
Reserves	1,301,000	1,066,000
Accumulated losses	(44,204,000)	(36,186,000)
Equity attributable to the owners of Kazia Therapeutics Limited	37,851,000	14,125,000
Total equity	$ 37,851,000	$ 14,125,000

XML

Statements of changes in equity - AUD ($)	Total	Contributed equity [member]	Other Contributed equity [member]	Reserves [member]	Accumulated Losses [member]	Non-controlling interests [member]
Beginning Balance (Previously stated [member]) at Jun. 30, 2018	$ 19,242,000	$ 31,576,000	$ 464,000	$ 1,843,000	$ (14,641,000)
Beginning Balance (Increase (decrease) due to changes in accounting policy [member]) at Jun. 30, 2018				37,000	(37,000)
Beginning Balance at Jun. 30, 2018	19,242,000	31,576,000	464,000	1,880,000	(14,678,000)
Loss after income tax expense for the year	(10,270,000)				(10,270,000)
Other comprehensive income for the year, net of tax	(89,000)			(89,000)
Total comprehensive income for the year	(10,359,000)			(89,000)	(10,270,000)
Transactions with owners in their capacity as owners:
Share issue costs	(340,000)	(340,000)
Transfers
Share based payment	246,000			246,000
Issue of shares	5,406,000	5,406,000
Ending balance at Jun. 30, 2019	14,195,000	36,641,519	464,000	2,037,000	(24,948,000)
Loss after income tax expense for the year	(12,467,466)				(12,467,000)
Other comprehensive income for the year, net of tax	(4,000)			(4,000)
Total comprehensive income for the year	(12,471,000)			(4,000)	(12,467,000)
Transactions with owners in their capacity as owners:
Share issue costs	(833,000)	(833,000)
Transfers
Conversion of convertible note
Employee share-based payment options
Share based payment	262,000			262,000
Issue of shares	12,972,000	12,972,000
Expired options				(1,230,000)	1,230,000
Ending balance at Jun. 30, 2020	14,125,000	48,781,214	464,000	1,066,000	(36,186,000)
Loss after income tax expense for the year	(8,421,960)				(8,422,000)
Other comprehensive income for the year, net of tax	2,000			2,000
Total comprehensive income for the year	(8,420,000)			2,000	(8,422,000)
Transactions with owners in their capacity as owners:
Contributions of equity, net of transaction costs	32,909,000	32,909,000
Share issue costs	(1,673,000)	(1,673,000)
Transfers
Conversion of convertible note
Employee share-based payment options
Share based payment	637,000			637,000
Issue of shares	273,000	273,000		(80,000)	80,000
Expired options				(323,000)	323,000
Ending balance at Jun. 30, 2021	$ 37,851,000	$ 80,290,062	$ 464,000	$ 1,301,000	$ (44,204,000)

XML

Consolidated statements of cash flows - AUD ($)	12 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2019
Cash flows from operating activities
Loss before income tax expense for the year	$ (8,421,960)	$ (12,467,466)	$ (10,270,000)
Adjustments for:
Depreciation and amortisation	1,265,000	1,084,000	1,084,000
Net loss on disposal of non-current assets
Impairment of property, plant and equipment			1,000
Share-based payments	637,000	262,000	246,000
Foreign exchange differences	430,000
Loss/(gain) on contingent consideration	2,570,000	474,000	63,000
Fair value loss on financial assets		168,000	1,809,000
Cash flows from used in operations before changes in working capital	(3,521,000)	(10,479,000)	(7,067,000)
Change in operating assets and liabilities:
Increase in trade and other receivables	(5,027,000)	358,000	825,000
Increase/(decrease) in prepayments	(1,182,000)	(168,000)	398,000
Increase/(decrease) in trade and other payables	1,010,000	1,722,000	(409,000)
Increase/(decrease) in other provisions	93,000	55,000	(25,000)
Decrease in deferred tax liability	(484,000)	(298,000)	(298,000)
Increase/(decrease) in accrued revenue			(138,000)
Net cash used in operating activities	(9,111,000)	(8,810,000)	(6,714,000)
Cash flows from investing activities
Proceeds from disposal of shares			2,359,000
Net cash used in investing activities			2,359,000
Cash flows from financing activities
Proceeds from issue of shares	28,109,000	12,139,000	3,816,000
Net cash from financing activities	28,109,000	12,139,000	3,816,000
Net decrease in cash and cash equivalents	18,998,000	3,329,000	(539,000)
Cash and cash equivalents at the beginning of the financial year	8,764,044	5,434,000	5,956,000
Effects of exchange rate changes on cash	(175,000)		17,000
Cash and cash equivalents at the end of the financial year	$ 27,586,760	$ 8,764,044	$ 5,434,000

XML

General information

12 Months Ended

Jun. 30, 2021

Text block [abstract]

General information

Note 1. General information

The financial statements cover Kazia Therapeutics Limited as a consolidated entity consisting of Kazia Therapeutics Limited and its subsidiaries. The financial statements are presented in Australian dollars, which is Kazia Therapeutics Limited’s functional and presentation currency.

Kazia Therapeutics Limited is a listed public company limited by shares, incorporated and domiciled in Australia. Its registered office and principal place of business is:

Three International Towers

Level 24, 300 Barangaroo Avenue

Sydney NSW 2000

The financial statements were authorised for issue, in accordance with a resolution of Directors, on 7 October 2021. The Directors have the power to amend and reissue the financial statements.

XML

Significant accounting policies

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Significant accounting policies

Note 2. Significant accounting policies

The principal accounting policies adopted in the preparation of the financial statements are set out below. These policies have been consistently applied to all the years presented, unless otherwise stated.

New or amended Accounting Standards and Interpretations adopted

The consolidated entity has adopted all of the new, revised or amending Accounting Standards and Interpretations issued by the International Accounting Standards Board (‘IASB’) that are mandatory for the current reporting period.

The adoption of these Accounting Standards and Interpretations did not have any significant impact on the financial performance or position of the consolidated entity. Any new, revised or amending Accounting Standards or Interpretations that are not yet mandatory have not been early adopted.

New Accounting Standards and Interpretations not yet mandatory or early adopted

Australian Accounting Standards and Interpretations that have recently been issued or amended but are not yet mandatory, have not been early adopted by the consolidated entity for the annual reporting period ended 30 June 2021. The consolidated entity’s assessment of the impact of these new or amended Accounting Standards and Interpretations is that none are deemed to have a material impact on the entity.

Going concern

The consolidated entity incurred a loss after income tax of $8,421,960 (2020: $12,467,466), was in a net current asset position of $21,064,264(2020: net current asset position of $5,586,128) and had net cash outflows from operating activities of $9,110,516(2020: $8,809,519) for the year ended 30 June 2021.

As at 30 June 2021 the consolidated entity had cash in hand and at bank of $27,586,760.

The financial statements have been prepared on a going concern basis, which contemplates continuity of normal activities and realisation of assets and settlement of liabilities in the normal course of business. As is often the case with drug development companies, the ability of the consolidated entity to continue its development activities as a going concern is dependent upon it deriving sufficient cash from investors, from licensing and partnering activities, and from other sources of revenue such as grant funding.

The directors have considered the cash flow forecasts and the funding requirements of the business and continue to explore grant funding, licensing opportunities and equity investment opportunities in the Company. In particular, the directors have considered the impact of COVID-19 on the operations of the Company, and make the following observations:

• Kazia’s key clinical trials have not been impacted by COVID-19 to date. The GBM Agile study, the pivotal study for paxalisib in glioblastoma, is on track with recruitment running to plan, and no disruption to this schedule is foreseen. The Phase II study of paxalisib in glioblastoma was fully recruited prior to the onset of restrictions and is in wrap up stage at the date of this report. Plans are on track for the commencement of a Phase I trial for EVT801 before the end of 2021;

• In general, clinical research in advanced cancer is relatively protected from pandemic disruption due to the ongoing and time-critical need for patient care in specialised facilities that cannot easily be repurposed;

• The Company is not reliant on ongoing revenue from customers, and so changes in customer behaviour over the next several years due to public health restrictions and reduced economic activity have little to no impact on its finances;

• The Company was able to secure funding of approximately $9 million at the height of the initial wave of COVID-19 in April 2020, and additional funds of approximately $25 million during the 2021 financial year;

• Based on budgets and forecasts, the Company has sufficient cash to fund the operations for a period of at least 12 months from the date of this report; and

• As a consequence the directors do not foresee any other impacts on the Company’s ability to raise additional funding as a result of COVID-19.

Accordingly the directors have prepared the financial statements on a going concern basis. Should the above assumptions not prove to be appropriate, there is material uncertainty whether the consolidated entity will continue as a going concern and therefore whether it will realise its assets and extinguish its liabilities in the normal course of business and at the amounts stated in these financial statements.

Basis of preparation

These general purpose financial statements have been prepared in accordance with Australian Accounting Standards and Interpretations issued by the Australian Accounting Standards Board (‘AASB’) and the Corporations Act 2001, as appropriate for for-profit oriented entities. These financial statements also comply with International Financial Reporting Standards as issued by the International Accounting Standards Board (‘IASB’).

The financial statements have been prepared on an accruals basis and under the historical cost conventions, except for listed equity investments which are carried at fair value.

Critical accounting estimates

The preparation of the financial statements requires the use of certain critical accounting estimates. It also requires management to exercise its judgement in the process of applying the consolidated entity’s accounting policies. The areas involving a higher degree of judgement or complexity, or areas where assumptions and estimates are significant to the financial statements, are disclosed in note 3.

Parent entity information

In accordance with the Corporations Act 2001, these financial statements present the results of the consolidated entity only. Supplementary information about the parent entity is disclosed in note 28.

Principles of consolidation

The consolidated financial statements incorporate the assets and liabilities of all subsidiaries of Kazia Therapeutics Limited (‘company’ or ‘parent entity’) as at 30 June 2021 and the results of all subsidiaries for the year then ended. Kazia Therapeutics Limited and its subsidiaries together are referred to in these financial statements as the ‘consolidated entity’.

Subsidiaries are all those entities over which the consolidated entity has control. The consolidated entity controls an entity when the consolidated entity is exposed to, or has rights to, variable returns from its involvement with the entity and has the ability to affect those returns through its power to direct the activities of the entity. Subsidiaries are fully consolidated from the date on which control is transferred to the consolidated entity. They are de-consolidated from the date that control ceases.

Intercompany transactions, balances and unrealised gains on transactions between entities in the consolidated entity are eliminated. Unrealised losses are also eliminated unless the transaction provides evidence of the impairment of the asset transferred. Accounting policies of subsidiaries have been changed where necessary to ensure consistency with the policies adopted by the consolidated entity.

The acquisition of subsidiaries is accounted for using the acquisition method of accounting. A change in ownership interest, without the loss of control, is accounted for as an equity transaction, where the difference is between the consideration transferred and the book value.

Where the consolidated entity loses control over a subsidiary, it derecognises the assets including goodwill, liabilities and non-controlling interest in the subsidiary together with any cumulative translation differences recognised in equity. The consolidated entity recognises the fair value of the consideration received and the fair value of any investment retained together with any gain or loss in profit or loss.

Operating segments

Operating segments are presented using the ‘management approach’, where the information presented is on the same basis as the internal reports provided to the Chief Operating Decision Makers (‘CODM’). The CODM is responsible for the allocation of resources to operating segments and assessing their performance. The CODM is considered to be the Board of Directors.

Foreign currency translation

The financial statements are presented in Australian dollars, which is the consolidated entity’s functional and presentation currency.

Foreign currency transactions

Foreign currency transactions are translated into Australian dollars using the exchange rates prevailing at the dates of the transactions. Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation at financial year-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognised in profit or loss.

Foreign operations

The assets and liabilities of foreign operations are translated into Australian dollars using the exchange rates at the reporting date. The revenues and expenses of foreign operations are translated into Australian dollars using the average exchange rates, which approximate the rate at the date of the transaction, for the period. All resulting foreign exchange differences are recognised in other comprehensive income through the foreign currency reserve in equity.

The foreign currency reserve is recognised in profit or loss when the foreign operation is disposed of.

Exchange differences arising on a monetary item that forms part of a reporting entity’s net investment in a foreign operation shall be recognised initially in other comprehensive income and reclassified from equity to profit or loss on disposal of the net investment.

Financial Instruments

Recognition and derecognition

Financial assets and financial liabilities are recognised when the Group becomes a party to the contractual provisions of the financial instrument and are measured initially at fair value adjusted by transactions costs, except for those carried at fair value through profit or loss, which are measured initially at fair value. Subsequent measurement of financial assets and financial liabilities are described below. Financial assets are derecognised when the contractual rights to the cash flows from the financial asset expire, or when the financial asset and substantially all the risks and rewards are transferred. A financial liability is derecognised when it is extinguished, discharged, cancelled or expires.

Classification and initial measurement of financial assets

Except for those trade receivables that do not contain a significant financing component and are measured at the transaction price in accordance with IFRS 15, all financial assets are initially measured at fair value adjusted for transaction costs (where applicable).

Subsequent measurement of financial assets

For the purpose of subsequent measurement, financial assets are classified into the following categories upon initial recognition:

• financial assets at amortised cost

• financial assets at fair value through profit or loss (FVPL)

Classifications are determined by both:

• The entity’s business model for managing the financial asset

• The contractual cash flow characteristics of the financial assets

All income and expenses relating to financial assets that are recognised in profit or loss are presented within finance costs, finance income or other financial items, except for impairment of trade receivables which is presented within other expenses.

Financial assets at amortised cost

Financial assets are measured at amortised cost if the assets meet the following conditions (and are not designated as FVPL):

• they are held within a business model whose objective is to hold the financial assets and collect its contractual cash flows

• the contractual terms of the financial assets give rise to cash flows that are solely payments of principal and interest on the principal amount outstanding

After initial recognition, these are measured at amortised cost using the effective interest method. Discounting is omitted where the effect of discounting is immaterial. The Group’s cash and cash equivalents, trade and most other receivables fall into this category of financial instruments.

Financial assets at fair value through profit or loss (FVPL)

Financial assets that are held within a business model other than ‘hold to collect’ or ‘hold to collect and sell’ are categorised at fair value through profit and loss. Further, irrespective of business model, financial assets whose contractual cash flows are not solely payments of principal and interest are accounted for at FVPL. The Group’s investments in equity instruments and derivatives fall under this category.

Impairment of financial assets

IFRS 9’s new impairment model uses more forward looking information to recognize expected credit losses—the ‘expected credit losses (ECL) model’. The application of the new impairment model depends on whether there has been a significant increase in credit risk. The Group considers a broader range of information when assessing credit risk and measuring expected credit losses, including past events, current conditions, reasonable and supportable forecasts that affect the expected collectability of the future cash flows of the instrument.

In applying this forward-looking approach, a distinction is made between:

• financial instruments that have not deteriorated significantly in credit quality since initial recognition or that have low credit risk (‘Stage 1’) and

• financial instruments that have deteriorated significantly in credit quality since initial recognition and whose credit risk is not low (‘Stage 2’).

‘Stage 3’ would cover financial assets that have objective evidence of impairment at the reporting date. ‘12-month expected credit losses’ are recognised for the first category while ‘lifetime expected credit losses’ are recognised for the second category. Measurement of the expected credit losses is determined by a probability-weighted estimate of credit losses over the expected life of the financial instrument.

Classification and measurement of financial liabilities

The Group’s financial liabilities comprise trade and other payables. Financial liabilities are initially measured at fair value, and, where applicable, adjusted for transaction costs unless the Group designated a financial liability at fair value through profit or loss. Subsequently, financial liabilities are measured at amortised cost using the effective interest method.

All interest-related charges and, if applicable, changes in an instrument’s fair value that are reported in profit or loss are included within finance costs or finance income.

Revenue from contracts with customers

Revenue is measured at the fair value of the consideration received or receivable. Amounts disclosed as revenue are net of returns, trade allowances, rebates and amounts collected on behalf of third parties. Revenue is recognised using a five step approach in accordance with IFRS 15 Revenue from Contracts with Customers to depict the transfer of promised services to customers in an amount that reflects the consideration to which the Group expects to be entitled in exchange for those services. Distinct promises within the contract are identified as performance obligations. The transaction price of the contract is measured based on the amount of consideration the consolidated entity expects to be entitled to from the customer in exchange for services. Factors such as requirements around variable consideration, significant financing components, noncash consideration, or amounts payable to customers also determine the transaction price. The transaction is then allocated to separate performance obligations in the contract based on relative standalone selling prices. Revenue is recognised when, or as, performance obligations are satisfied, which is when control of the promised service is transferred to the customer. Amounts received prior to satisfying the revenue recognition criteria are recorded as deferred revenue. Amounts expected to be recognised as revenue within the 12 months following the balance sheet date are classified within current liabilities. Amounts not expected to be recognised as revenue within the 12 months following the balance sheet date are classified within non-current liabilities.

The consolidated entity recognises contract liabilities for consideration received in respect of unsatisfied performance obligations and reports these amounts as other liabilities in its consolidated statement of financial position. Similarly, if the consolidated entity satisfies a performance obligation before it receives the consideration, the consolidated entity recognises either a contract asset or a receivable in its statement of financial position, depending on whether something other than the passage of time is required before the consideration is due.

Licensing revenues, including milestone revenue

Revenue from licensees of the consolidated entity’s intellectual property reflects the transfer of a right to use the intellectual property as it exists at the point in time in which the licence is transferred to the customer.

Licensing agreements are examined to determine whether they contain additional performance obligations, over and above the right to use the intellectual property. To the extent that additional performance obligations exist, the transaction price the consolidated entity expects to receive for the contract is allocated to the separate performance obligations.

The receipt of milestone payments is often contingent on meeting certain clinical, regulatory or commercial targets, and is therefore considered variable consideration. The transaction price of the contingent milestone is estimated using the most likely amount method. Within the transaction price, the price associated with a contingent milestone is included only to the extent that it is highly probable that a significant reversal in the amount of cumulative revenue recognized will not occur. Milestone payments that are not within the control of the Group, such as regulatory approvals, are not considered highly probable of being achieved until those approvals are achieved.

Finance Income

Interest revenue is recognised as interest accrues using the effective interest method. This is a method of calculating the amortised cost of a financial asset and allocating the interest income over the relevant period using the effective interest rate, which is the rate that exactly discounts estimated future cash receipts through the expected life of the financial asset to the net carrying amount of the financial asset.

Other revenue

Other revenue is recognised when it is received or when the right to receive payment is established.

Grant income

The R&D Tax Incentive is a government program which helps to offset some of the incurred costs of R&D. Eligible expenditure incurred under the scheme in a financial year attracts an additional 43.5% tax deduction, and for a group earning income of less than $20 million, the cash value of the additional deduction is remitted to the taxpayer. In accordance with IAS 20, as the compensation relates to expenses already incurred, it is recognised in profit or loss of the period in which it becomes receivable. Accordingly the group accounts for the R&D Tax Incentive in the same year as the expenses to which it relates.

Income tax

The income tax expense or benefit for the period is the tax payable on that period’s taxable income based on the applicable income tax rate for each jurisdiction, adjusted by changes in deferred tax assets and liabilities attributable to temporary differences, unused tax losses and the adjustment recognised for prior periods, where applicable.

Deferred tax assets and liabilities are recognised for temporary differences at the tax rates expected to apply when the assets are recovered or liabilities are settled, based on those tax rates that are enacted or substantively enacted, except for:

• When the deferred income tax asset or liability arises from the initial recognition of goodwill or an asset or liability in a transaction that is not a business combination and that, at the time of the transaction, affects neither the accounting nor taxable profits; or

• When the taxable temporary difference is associated with interests in subsidiaries, associates or joint ventures, and the timing of the reversal can be controlled and it is probable that the temporary difference will not reverse in the foreseeable future.

Deferred tax assets are recognised for deductible temporary differences and unused tax losses only if it is probable that future taxable amounts will be available to utilise those temporary differences and losses.

The carrying amount of recognised and unrecognised deferred tax assets are reviewed each reporting date. Deferred tax assets recognised are reduced to the extent that it is no longer probable that future taxable profits will be available for the carrying amount to be recovered. Previously unrecognised deferred tax assets are recognised to the extent that it is probable that there are future taxable profits available to recover the asset.

Deferred tax assets and liabilities are offset only where there is a legally enforceable right to offset current tax assets against current tax liabilities and deferred tax assets against deferred tax liabilities; and they relate to the same taxable authority on either the same taxable entity or different taxable entities which intend to settle simultaneously.

Kazia Therapeutics Limited (the ‘parent entity’) and its wholly-owned Australian controlled entities have formed an income tax consolidated group under the tax consolidation regime. Kazia Therapeutics Limited as the parent entity discloses all of the deferred tax assets of the tax consolidated group in relation to tax losses carried forward (after elimination of inter-group transactions). The tax consolidated group has applied the ‘separate taxpayer in the group’ allocation approach in determining the appropriate amount of taxes to allocate to members of the tax consolidated group.

As the tax consolidation group continues to generate tax losses there has been no reason for the company to enter a tax funding agreement with members of the tax consolidation group.

Interpretation 23 Uncertain tax positions

Interpretation 23 clarified the application of the recognition and measurement criteria IAS 12 Income Taxes where there is uncertainty over income tax treatments and requires an assessment of each uncertain tax position as to whether it is probable that a taxation authority will accept the position. Where it is not probable, the effect of the uncertainty is reflected in determining the relevant taxable profit or loss, tax bases, unused tax losses and unused tax credits or tax rates. The amount is determined as either the single most likely amount or the sum of the probability weighted amounts in a range of possible outcomes, whichever better predicts the resolution of the uncertainty. Judgments are reassessed as and when new facts and circumstances are presented.

Current and non-current classification

Assets and liabilities are presented in the statement of financial position based on current and non-current classification.

An asset is current when: it is expected to be realised or intended to be sold or consumed in normal operating cycle; it is held primarily for the purpose of trading; it is expected to be realised within 12 months after the reporting period; or the asset is cash or cash equivalent unless restricted from being exchanged or used to settle a liability for at least 12 months after the reporting period. All other assets are classified as non-current.

A liability is current when: it is expected to be settled in normal operating cycle; it is held primarily for the purpose of trading; it is due to be settled within 12 months after the reporting period; or there is no unconditional right to defer the settlement of the liability for at least 12 months after the reporting period. All other liabilities are classified as non-current.

Deferred tax assets and liabilities are always classified as non-current.

Cash and cash equivalents

Cash and cash equivalents includes cash on hand, deposits held at call with financial institutions, other short-term, highly liquid investments with original maturities of three months or less that are readily convertible to known amounts of cash and which are subject to an insignificant risk of changes in value.

Research and development

Expenditure during the research phase of a project is recognised as an expense when incurred. Development costs are capitalised only when technical feasibility studies identify that the project will deliver future economic benefits and these benefits can be measured reliably.

Leases

Under IFRS 16, leases are accounted for as follows:

• Right-of-use assets and lease liabilities are recognised in the consolidated statement of financial position, initially measured at the present value of future lease payments;

• Depreciation on right-of-use assets and interest on lease liabilities are recognised in the consolidated statement of profit or loss; and

• The total amount of cash paid under lease arrangements is separated into a principal portion (presented within financing activities) and interest (presented within operating activities) in the consolidated cash flow statement.

Lease incentives under IFRS 16 are recognised as part of the measurement of right-of-use assets and lease liabilities.

Under IFRS 16, right-of-use assets are tested for impairment in accordance with IAS 36 Impairment of assets. This replaces the previous requirement to recognise a provision for onerous lease contracts.

For short-term leases (lease term of 12 months or less) and leases of low-value assets, the consolidated entity has opted to recognise a lease expense on a straight-line basis as permitted by IFRS 16 Leases. This expense is presented within other expenses in the consolidated statement of profit or loss.

Intangible assets

Intangible assets acquired as part of a business combination, other than goodwill, are initially measured at their fair value at the date of the acquisition. Intangible assets acquired separately are initially recognised at cost. Indefinite life intangible assets are not amortised and are subsequently measured at cost less any impairment. Finite life intangible assets are subsequently measured at cost less amortisation and any impairment. The gains or losses recognised in profit or loss arising from derecognition of intangible assets are measured as the difference between net disposal proceeds and the carrying amount of the intangible asset. The method and useful lives of finite life intangible assets are reviewed annually. Changes in the expected pattern of consumption or useful life are accounted for prospectively by changing the amortisation method or period. Amortisation expense is included in research and development expenditure.

Licensing agreement for paxalisib

The Licensing Agreement asset was initially brought to account at fair value, and is being amortised on a straight-line basis over the period of its expected benefit, being the remaining life of the patent, which was 15 years from the date of acquisition.

Licensing agreement for EVT801

The Licensing agreement asset was initially brought to account at cost and is being amortised on a straight-line basis over the period of its expected benefit, being the remaining life of the patent, which was 12.5 years from the date of acquisition.

Impairment of non-financial assets

Non-financial assets with finite useful lives are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. An impairment loss is recognised for the amount by which the asset’s carrying amount exceeds its recoverable amount.

Recoverable amount is the higher of an asset’s fair value less costs of disposal and value-in-use. The value-in-use is the present value of the estimated future cash flows relating to the asset using a pre-tax discount rate specific to the asset or cash-generating unit to which the asset belongs. Assets that do not have independent cash flows are grouped together to form a cash-generating unit.

Compound financial instruments

Subsequent to initial recognition, the liability component of a compound financial instrument is measured at amortised cost using the effective interest rate method, whereas the equity component is not remeasured. Interest, gains and losses relating to the financial liability are recognised in profit or loss. On conversion, the financial liability is reclassified to equity; no gain or loss is recognised on conversion.

Provisions

Provisions are recognised when the consolidated entity has a present (legal or constructive) obligation as a result of a past event, it is probable the consolidated entity will be required to settle the obligation, and a reliable estimate can be made of the amount of the obligation. The amount recognised as a provision is the best estimate of the consideration required to settle the present obligation at the reporting date, taking into account the risks and uncertainties surrounding the obligation. If the time value of money is material, provisions are discounted using a current pre-tax rate specific to the liability. The increase in the provision resulting from the passage of time is recognised as a finance cost.

Employee benefits

Short-term employee benefits

Liabilities for wages and salaries, including non-monetary benefits, annual leave and long service leave expected to be settled within 12 months of the reporting date are measured at the amounts expected to be paid when the liabilities are settled.

Other long-term employee benefits

The liability for annual leave and long service leave not expected to be settled within 12 months of the reporting date is measured as the present value of expected future payments to be made in respect of services provided by employees up to the reporting date using the projected unit credit method. Consideration is given to expected future wage and salary levels, experience of employee departures and periods of service. Expected future payments are discounted using market yields at the reporting date on high quality corporate bonds with terms to maturity and currency that match, as closely as possible, the estimated future cash outflows.

Defined contribution superannuation expense

Contributions to defined contribution superannuation plans are expensed in the period in which they are incurred.

Share-based payments

Equity-settled share-based compensation benefits are provided to employees under the terms of the Employee Share Option Plan (‘ESOP’) and consultants as compensation for services performed.

Equity-settled transactions are awards of shares, or options over shares that are provided to employees in exchange for the rendering of services.

The cost of equity-settled transactions are measured at fair value on grant date. Fair value is independently determined using the Black-Scholes option pricing model that takes into account the exercise price, the term of the option, the impact of dilution, the share price at grant date and expected price volatility of the underlying share, the expected dividend yield and the risk free interest rate for the term of the option, together with non-vesting conditions that do not determine whether the consolidated entity receives the services that entitle the employees to receive payment. No account is taken of any other vesting conditions.

The cost of equity-settled transactions are recognised as an expense with a corresponding increase in equity over the vesting period. The cumulative charge to profit or loss is calculated based on the grant date fair value of the award, the best estimate of the number of awards that are likely to vest and the expired portion of the vesting period. The amount recognised in profit or loss for the period is the cumulative amount calculated at each reporting date less amounts already recognised in previous periods.

The cumulative charge to profit or loss until settlement of the liability is calculated as follows:

• during the vesting period, the liability at each reporting date is the fair value of the award at that date multiplied by the expired portion of the vesting period.

• from the end of the vesting period until settlement of the award, the liability is the full fair value of the liability at the reporting date.

Market conditions are taken into consideration in determining fair value. Therefore any awards subject to market conditions are considered to vest irrespective of whether or not that market condition has been met, provided all other conditions are satisfied.

If equity-settled awards are modified, as a minimum an expense is recognised as if the modification has not been made. An additional expense is recognised, over the remaining vesting period, for any modification that increases the total fair value of the share-based compensation benefit as at the date of modification.

If the non-vesting condition is within the control of the consolidated entity or employee, the failure to satisfy the condition is treated as a cancellation. If the condition is not within the control of the consolidated entity or employee and is not satisfied during the vesting period, any remaining expense for the award is recognised over the remaining vesting period, unless the award is forfeited.

If equity-settled awards are cancelled, it is treated as if it has vested on the date of cancellation, and any remaining expense is recognised immediately. If a new replacement award is substituted for the cancelled award, the cancelled and new award is treated as if they were a modification.

Finance costs

Finance costs attributable to qualifying assets are capitalised as part of the asset. All other finance costs are expensed in the period in which they are incurred, including interest on short-term and long-term borrowings.

Fair value measurement

When an asset or liability, financial or non-financial, is measured at fair value for recognition or disclosure purposes, the fair value is based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date; and assumes that the transaction will take place either: in the principal market; or in the absence of a principal market, in the most advantageous market.

Fair value is measured using the assumptions that market participants would use when pricing the asset or liability, assuming they act in their economic best interest. For non-financial assets, the fair value measurement is based on its highest and best use. Valuation techniques that are appropriate in the circumstances and for which sufficient data are available to measure fair value, are used, maximising the use of relevant observable inputs and minimising the use of unobservable inputs.

Assets and liabilities measured at fair value are classified, into three levels, using a fair value hierarchy that reflects the significance of the inputs used in making the measurements. Classifications are reviewed each reporting date and transfers between levels are determined based on a reassessment of the lowest level input that is significant to the fair value measurement.

For recurring and non-recurring fair value measurements, external valuers may be used when internal expertise is either not available or when the valuation is deemed to be significant. External valuers are selected based on market knowledge and reputation. Where there is a significant change in fair value of an asset or liability from one period to another, an analysis is undertaken, which includes a verification of the major inputs applied in the latest valuation and a comparison, where applicable, with external sources of data.

Issued capital

Ordinary shares are classified as equity.

Incremental costs directly attributable to the issue of new shares or options, including share based payments relating to the issue of shares are, shown in equity as a deduction, net of tax, from the proceeds.

Earnings per share

Basic earnings per share

Basic earnings per share is calculated by dividing the profit attributable to the owners of Kazia Therapeutics Limited, excluding any costs of servicing equity other than ordinary shares, by the weighted average number of ordinary shares outstanding during the financial year, adjusted for bonus elements in ordinary shares issued during the financial year.

Diluted earnings per share

Diluted earnings per share adjusts the figures used in the determination of basic earnings per share to take into account the after income tax effect of interest and other financing costs associated with dilutive potential ordinary shares and the weighted average number of shares assumed to have been issued for no consideration in relation to dilutive potential ordinary shares.

Goods and Services Tax (‘GST’) and other similar taxes

Revenues, expenses and assets are recognised net of the amount of associated GST, unless the GST incurred is not recoverable from the tax authority. In this case it is recognised as part of the cost of the acquisition of the asset or as part of the expense.

Receivables and payables are stated inclusive of the amount of GST receivable or payable. The net amount of GST recoverable from, or payable to, the tax authority is included in other receivables or other payables in the statement of financial position.

Cash flows are presented on a gross basis. The GST components of cash flows arising from investing or financing activities which are recoverable from, or payable to the tax authority, are presented as operating cash flows.

Commitments and contingencies are disclosed net of the amount of GST recoverable from, or payable to, the tax authority.

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Critical accounting judgements, estimates and assumptions

12 Months Ended

Jun. 30, 2021

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Critical accounting judgements, estimates and assumptions

Note 3. Critical accounting judgements, estimates and assumptions

The preparation of the financial statements requires management to make judgements, estimates and assumptions that affect the reported amounts in the financial statements. Management continually evaluates its judgements and estimates in relation to assets, liabilities, contingent liabilities, revenue and expenses. Management bases its judgements, estimates and assumptions on historical experience and on other various factors, including expectations of future events, management believes to be reasonable under the circumstances. The resulting accounting judgements and estimates will seldom equal the related actual results. The judgements, estimates and assumptions that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities (refer to the respective notes) within the next financial year are discussed as follows:

Research and development expenses

The Directors do not consider the development programs to be sufficiently advanced to reliably determine the economic benefits and technical feasibility to justify capitalisation of development costs. These costs have been recognised as an expense when incurred.

Research and development expenses relate primarily to the cost of conducting human clinical and pre-clinical trials. Clinical development costs are a significant component of research and development expenses. Estimates have been used in determining the expense liability under certain clinical trial contracts where services have been performed but not yet invoiced. Generally the costs, and therefore estimates, associated with clinical trial contracts are based on the number of patients, drug administration cycles, the type of treatment and the outcome being measured. The length of time before actual amounts can be determined will vary depending on length of the patient cycles and the timing of the invoices by the clinical trial partners.

Revenue recognition

The consolidated entity applies judgement in determining whether contracts entered into fall within the scope of IFRS 15 Revenue from Contracts with Customers. In doing so, management considers the commercial substance of the transaction and how risks and benefits of the contract accrue to the various parties to the contract. In determining the accounting treatment of the contracts with each customer, management assessed that the contracts were within the scope of IFRS 15 ‘Revenue from Contracts with Customers’. Management has also made the judgement in each case that the grant of the licence and transfer of associated know-how and materials are accounted for as one performance obligation as they are not considered to be distinct; they are highly interrelated and could not provide benefits to the customer independently from each other. Judgements were also made in relation to the transfer of the licence and know-how in each case, and whether this should be recognised over time or a point in time. The point in time has been determined with regard to the point at which the transfer of know-how has substantially been completed and the customer has control of the asset and the ability to direct the use of and receive substantially all of the remaining benefits.

Clinical trial expenses

The timing of payment for work conducted under clinical trials often bears little relation to the timing of the work effort. Detailed estimates are made to determine the amount of work effort expended during a reporting period in order to determine the appropriate expense to be recognised, with the resulting prepayments or un-invoiced amounts being recognised as a prepayment or an accrual respectively.

Share-based payment transactions

The consolidated entity measures the cost of equity-settled transactions with employees by reference to the fair value of the equity instruments at the date at which they are granted. The fair value is determined by using the Black-Scholes option pricing model taking into account the terms and conditions upon which the instruments were granted. The accounting estimates and assumptions relating to equity-settled share-based payments would have no impact on the carrying amounts of assets and liabilities within the next annual reporting period but may impact profit or loss and equity.

Acquisition of intangible assets

The consolidated entity has applied judgement in determining the accounting treatment for the acquisition of the License agreement for EVT801. The License agreement has been determined to be a stand alone transaction, independent from any other agreements which have been or may be entered into with Evotec (France) SAS. Management has also made the decision to account for the cost of the asset conferred by the License agreement on the basis of the milestones that are probable of being payable, that is, those for which there is judged to be a probability of greater than 50% that the milestone will be triggered.

Contingent consideration

Contingent consideration relates to the intangible assets acquired, and the fair value of contingent consideration is dependent on the key assumptions used in accounting for the acquisition of those intangible assets. These assumptions include the probability of milestones occurring, and can also include the anticipated timing of settlement and discount rates used.

In the case where contingent consideration is recognised on the basis that the liability is probable of occurring, judgement is used in determining which milestones are considered probable of being triggered.

Intangible assets available for use

The consolidated entity has exercised judgement in determining that its intangible assets, being license agreements, have a finite life and are available for use once acquired. As the business model is to acquire such assets and then develop them to generate returns from future license transactions or other means, management have determined that the assets are available for use from the time that they are acquired. In each case the prima facie useful life is the remaining life of the patent over the asset, unless other factors over-ride this assessment.

Impairment of non-financial assets other than goodwill and other indefinite life intangible assets

The consolidated entity assesses impairment of non-financial assets other than goodwill and other indefinite life intangible assets at each reporting date by evaluating conditions specific to the consolidated entity and to the particular asset that may lead to impairment. Judgement is used to determine whether any indicators of impairment exist, and reference is made to the considerations included in IAS 36 Impairment of Assets in this assessment. If an impairment trigger is found to exist, the recoverable amount of the asset is determined.

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Operating segments

12 Months Ended

Jun. 30, 2021

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Operating segments

Note 4. Operating segments

Identification of reportable operating segments

The consolidated entity’s operating segment is based on the internal reports that are reviewed and used by the Board of Directors (being the Chief Operating Decision Makers (‘CODM’)) in assessing performance and in determining the allocation of resources.

The consolidated entity operates in the pharmaceutical research and development business. There are no operating segments for which discrete financial information exists.

The information reported to the CODM, on at least a quarterly basis, is the consolidated results as shown in the statement of profit or loss and other comprehensive income and statement of financial position.

Major customers

During the year the consolidated entity transacted with two customers, and revenue from each customer amounted to in excess of 10% of the total revenue from the period. Both companies entered into license agreements for the consolidated entity’s drug assets.

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Revenue

12 Months Ended

Jun. 30, 2021

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Revenue

Note 5. Revenue

	Consolidated
	2021 A$’000		2020 A$’000		2019 A$’000
Licensing revenue		15,183		—		—

Disaggregation of revenue

The disaggregation of revenue from contracts with customers is as follows:

	Consolidated
	2021 A$’000		2020 A$’000		2019 A$’000
Geographical regions
China		10,006		—		—
Sweden		5,177		—		—
		15,183		—		—
Timing of revenue recognition
Licensing revenue at a point in time		15,183		—		—

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Other income

12 Months Ended

Jun. 30, 2021

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Other income

Note 6. Other income

	Consolidated
	2021 A$’000		2020 A$’000		2019 A$’000
Net foreign exchange gain		—		5		—
Payroll tax rebate		2		2		—
Subsidies and grants		—		20		9
Reimbursement of expenses		—		—		25
Research and development rebate		—		968		1,431
Other income		2		995		1,465

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Expenses

12 Months Ended

Jun. 30, 2021

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Expenses

Note 7. Expenses

	Consolidated
	2021		2020		2019
	A$’000		A$’000		A$’000
Loss before income tax includes the following specific
Amortisation
Paxalisib licensing agreement		1,084		1,084		1,084
Evotech licensing agreement		181		—		—
Total amortisation		1,265		1,084		1,084
Net foreign exchange loss
Net foreign exchange loss		430		—		18
Rental expense relating to operating leases
Minimum lease payments		93		108		79
Superannuation expense
Defined contribution superannuation expense		138		140		128
Employee benefits expense excluding superannuation
Employee benefits expense excluding superannuation		1,563		1,526		1,396
Other Expenses
Chinese With-Holding Tax incurred on license transaction		931		—		—
Chinese Value Added Tax incurred on license transaction		538		—		—
		1,469		—		—

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Income tax benefit

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Income tax benefit

Note 8. Income tax benefit

	2021			2020			2019
	A$’000			A$’000			A$’000
Numerical reconciliation of income tax benefit and tax at the statutory rate
Loss before income tax benefit		(8,906	)		(12,765	)		(10,568	)
Tax at the statutory tax rate of 26% (2020 & 2019 27.5%)		(2,316	)		(3,511	)		(2,906	)
Tax effect amounts which are not deductible/(taxable) in calculating taxable income:
Research and Development claim		—			280			394
Amortisation of intangibles		348			298			—
Employee option plan		175			72			67
Gain/loss on revaluation of contingent consideration		707			131			17
		(1,086	)		(2,730	)		(2,428	)
Adjustment to deferred tax balances as a result of change in statutory tax rate		(186	)		—			—
Tax losses and timing differences not recognised		788			2,432			2,130
Income tax benefit		(484	)		(298	)		(298	)
	2021			2020			2019
	A$’000			A$’000			A$’000
Tax losses not recognised
Unused tax losses for which no deferred tax asset has been recognised-Australia		70,896			67,430			57,050
Potential tax benefit @ 26.0% (2020 27.5%)- Australia		18,433			17,531			15,689
Unused tax losses for which no deferred tax asset has been recognised-US		2,038			1,570			2,366
Potential tax benefit at statutory tax rates@21%-US		428			330			497

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Current assets - cash and cash equivalents

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Current assets - cash and cash equivalents

Note 9. Current assets - cash and cash equivalents

	2021		2020
	A$’000		A$’000
Cash at bank and on hand		21,087		1,264
Short-term deposits		6,500		7,500
		27,587		8,764

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Trade and other receivables

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Trade and other receivables

Note 10. Trade and other receivables

	2021		2020
	A$’000		A$’000
Current assets
R&D tax rebate receivable		—		1,017
		—		1,017
Other receivables		76		177
Deposits held		8		567
Less: Provision for impairment of deposits held		—		(409	)
		84		1,352
Non-current assets
Deposit paid		6,694
		6,778		1,352

Of the deposit paid, $6.65m represents an advance to GCAR at the start of the GBM Agile trial, and is refundable if not utilised against trial expenses. The amount will be allocated against expenditure towards the latter end of the trial, which is expected to be over 12 months from year end.

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Other assets

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Current assets - other

Note 11. Other assets

Current assets

	2021		2020
	A$’000		A$’000
Prepayments		1,720		537

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Intangibles

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Intangibles

Note 12. Intangibles

Non-current assets

	Consolidated
	2021			2020
	A$’000			A$’000
Licensing agreement - at acquired fair value		16,408			16,408
Less: Accumulated amortisation		(5,082	)		(3,998	)
		11,326			12,410
Licensing agreement - at cost		10,858			—
Less: Accumulated amortisation		(181	)		—
		10,677			12,410
		22,003			12,410

Reconciliations

Reconciliations of the written down values at the beginning and end of the current and previous financial year are set out below:

	EVT801 licensing agreement A$’000			Paxalisib licensing agreement A$’000			Total A$’000
Balance at 1 July 2019		—			13,494			13,494
Additions
Disposals
Amortisation expense		—			(1,084	)		(1,084	)
Balance at 30 June 2020		—			12,410			12,410
Additions		10,858						10,858
Amortisation expense		(181	)		(1,084	)		(1,265	)
Balance at 30 June 2021		10,677			11,326			22,003

During the financial year the consolidated entity acquired exclusive rights to EVT801, a small-molecule selective inhibitor of vascular endothelial growth factor receptor 3 (VEGFR3).

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Trade and other payables

12 Months Ended

Jun. 30, 2021

1 year or less [member]

Statement [line items]

Trade and other payables

Note 13. Trade and other payables

	2021		2020
	A$’000		A$’000
Trade payables		1,893		1,694
Accrued payables		3,040		1,795
		4,933		3,489

Refer to note 21 for further information on financial instruments.

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Employee benefits

12 Months Ended

Jun. 30, 2021

1 year or less [member]

Statement [line items]

Employee benefits

Note 14. Employee benefits

	2021		2020
	A$’000		A$’000
Current Liabilities
Employee benefits		229		191
Non-Current Liabilities
Long service leave		55		—
		284		191

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Contingent consideration

12 Months Ended

Jun. 30, 2021

Later than one year [member]

Statement [line items]

Contingent consideration

Note 15. Contingent consideration

	2021 A$’000		2020 A$’000
Current Liabilities
Contingent consideration - paxalisib		—		1,387
Contingent consideration – EVT801		3,165		—
		3,165		1,387
Non-current Liabilities
Contingent consideration - paxalisib		1,015		458
Contingent consideration – EVT801		7,911		—
		8,927		458
		12,091		1,845

Contingent consideration - paxalisib

During the 2017 financial year, the consolidated entity acquired 100% of the issued shares in Glioblast Pty Ltd, a privately-held, neuro-oncology-focused Australian biotechnology company. On the same day, Kazia entered into a worldwide licensing agreement with Genentech to develop and commercialise GDC-0084, now known as paxalisib.

The Glioblast acquisition contains four contingent milestone payments, the first two milestone payments are to be settled with Kazia shares, and the third and fourth milestone payments are to be settled with either cash or Kazia shares at the discretion of Kazia. Milestones 1 and 4 have now been paid out, and Milestone 3 has lapsed. Milestone 2 comprises shares to the value of $1,250,000.

The Genentech agreement comprises of one milestone payment payable on the first commercial licensed product sale, in the amount of $1,394,000.

Each milestone payment is probability weighted for valuation purposes. The milestone payments are discounted to present value, using a discount rate of 15% (previously 35%) per annum. The discount rate was considered at 30 June 2021 and it was determined that the risk of the asset, and therefore of the milestones being met, has been considerably decreased as a result of paxalisib entering the pivotal GBM Agile trial, which is progressing well, and the license transaction with Simcere Pharmaceutical Group, which provides an external validation of paxalisib. Accordingly, the discount rate applied to future expected cash flows has been revised downwards.

Kazia is also required to pay royalties to Genentech in relation to net sales. These payments are related to future financial performance, and are not considered as part of the consideration in relation to the Genentech agreement.

Contingent consideration - EVT801

As set out in note 2, the acquisition of EVT801 has been accounted for at cost, with milestones where the payment is considered probable being booked as a current or non-current liability at year end, according to the estimated payment date. Milestones where the payment is not considered probable at year end have not been accounted for as a liability. The total amount of milestone payments not booked at year end amounts to €300,500,000 ($475,474,684).

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Deferred tax

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Deferred tax

Note 16. Deferred tax

	2021		2020
	A$’000		A$’000
Non-current Liabilities
Deferred tax liability associated with Licensing Agreement		2,928		3,413

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Equity - contributed equity

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Equity - contributed equity

Note 17. Equity - contributed equity

	Consolidated
	2021 Shares		2020 Shares		2021 $		2020 $
Ordinary shares - fully paid		132,012,209		94,598,369		80,290,062		48,781,214

Movements in Ordinary share capital

Details	Date	Shares		Issue price		$
Balance	1 July 2019		62,166,673				36,641,519
Share placement	1 November 2019		10,000,000	$	0.400		4,000,000
Share placement	16 April 2020		18,041,667	$	0.400		7,216,667
Issued under the Share Purchase Plan	11 May 2020		4,390,010	$	0.400		1,756,004
Issued on conversion of options			19	$	4.000		76
Share issue transaction costs			—	$	0.000		(833,052	)
Balance	30 June 2020		94,598,369				48,781,214
Issued on conversion of options	28 August 2020		25,000	$	0.493		12,313
Institutional placement under ANREO	12 October 2020		20,525,820	$	0.800		16,420,656
Retail placement under ANREO	26 October 2020		11,017,075	$	0.800		8,813,660
Issued on conversion of options	2 March 2021		391,500	$	0.635		248,661
Issued on conversion of options	15 March 2021		25,000	$	0.493		12,313
Share placement	28 April 2021		3,037,580	$	1.407		4,274,633
Issued on achievement of a milestone	21 May 2021		2,391,865	$	1.421		3,400,000
Less: share issue transaction costs			—	$	0.000		(1,673,388	)
Balance	30 June 2021		132,012,209				80,290,062

Ordinary shares

Ordinary shares entitle the holder to participate in dividends and the proceeds on the winding up of the company in proportion to the number of and amounts paid on the shares held. The fully paid ordinary shares have no par value and the company does not have a limited amount of authorised capital.

On a show of hands every member present at a meeting in person or by proxy shall have one vote and upon a poll each share shall have one vote.

Share buy-back

There is no current on-market share buy-back.

Capital risk management

The consolidated entity’s objectives when managing capital are to safeguard its ability to continue as a going concern, so that it can provide returns for shareholders and benefits for other stakeholders and to maintain an optimum capital structure to reduce the cost of capital.

Capital is regarded as total equity, as recognised in the statement of financial position, plus net debt. Net debt is calculated as total borrowings less cash and cash equivalents.

The capital structure of the consolidated entity consists of cash and cash equivalents and equity attributable to equity holders. The overall strategy of the consolidated entity is to continue its drug development programs, which depends on raising sufficient funds, through a variety of sources including issuing of additional share capital, as may be required from time to time.

The capital risk management policy remains unchanged from the prior year.

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Equity - Other contributed equity

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Equity - Other contributed equity

Note 18. Equity - Other contributed equity

	2021		2020
	$		$
Convertible note - Triaxial		464,000		464,000

On 4 December 2014, the consolidated entity and the convertible note holder (‘Triaxial’) signed a Convertible Note Deed Poll (‘Deed’) which superseded the precedent Loan Agreement between Triaxial shareholders and the consolidated entity. The Deed extinguishes the liability created by the Loan Agreement and provides that the Convertible Notes will convert into a pre-determined number of ordinary shares on the achievement of defined milestones established in the schedule of the Deed. Accordingly the convertible note has been reclassified as an equity instrument rather than debt instrument.

During the Financial year ended 30 June 2017, the Company reached two milestones triggering the conversion of a portion of its convertible note as follows;

• On 11 August 2016 the Company announced the submission of an IND application. On 10 September 2016, the Company received a letter from the FDA advising the study may proceed triggering conversion of 20,000,000 ordinary shares.

• On 31 October 2016, the Company announced it had licensed a Phase II ready molecule triggering the conversion of 16,000,000 ordinary shares.

During the financial year ended 30 June 2018, a portion of the convertible notes was extinguished.

The remaining portion of the convertible note will be exercised at the holders’ discretion on completion of Phase II clinical trial or achieving Breakthrough Designation, and would convert to 1,856,000 ordinary shares if converted. Completion will be deemed to occur upon the receipt by the consolidated entity of a signed study report or notification of the designation. There is a possibility for an early conversion of the convertible notes if a third party acquires more than 50% of the issued capital of the consolidated entity.​​​​​​​

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Equity - reserves

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Equity - reserves

Note 19. Equity - reserves

Foreign currency translation reserve

The reserve is used to recognise exchange differences arising from translation of the financial statements of foreign operations to Australian dollars.

Share-based payments reserve

The reserve is used to recognise the value of equity benefits provided to employees and executive directors as part of their remuneration, and other parties as part of their compensation for services.

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Equity - dividends

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Equity - dividends

Note 20. Equity - dividends

Dividends

There were no dividends paid, recommended or declared during the current or previous financial year.

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Financial instruments

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Financial instruments

Note 21. Financial instruments

Financial risk management objectives

The consolidated entity’s activities expose it to a variety of financial risks: market risk, credit risk and liquidity risk. The consolidated entity uses different methods to measure and manage the different types of risks to which it is exposed. These methods include monitoring the levels of exposure to interest rates and foreign exchange, ageing analysis and monitoring of specific credit allowances to manage credit risk, and, rolling cash flow forecasts to manage liquidity risk.

Market risk

Foreign currency risk

The consolidated entity operates internationally and is exposed to foreign exchange risk arising from various currency exposures, primarily with respect to the US dollars (‘USD’). Foreign exchange risk arises from future transactions and recognised assets and liabilities denominated in a currency that is not the entity’s functional currency and net investments in foreign operations.

As of 30 June 2021, the consolidated entity did not hold derivative financial instruments in managing its foreign currency, however, the consolidated entity may from time to time enter into hedging arrangements where circumstances are deemed appropriate. The consolidated entity used natural hedging to reduce the foreign currency risk, which involved processing USD payments from cash held in USD. Foreign subsidiaries with a functional currency of Australian Dollars (‘AUD’) have exposure to the local currency of these subsidiaries and any other currency these subsidiaries trade in.

The carrying amount of the consolidated entity’s foreign currency denominated financial assets and financial liabilities at the reporting date was as follows:

	Assets				Liabilities
	2021		2020		2021		2020
	A$’000		A$’000		A$’000		A$’000
US dollars		21,073		272		3,448		2,196
Euros		—		—		16		—
		21,073		272		3,464		2,196

The consolidated entity had net assets denominated in foreign currencies of A$17,608,845 as at 30 June 2021 (2020: net liabilities A$1,923,831).

If the AUD had strengthened against the USD by 10% (2020: 10%) then this would have had the following impact:

	AUD strengthened									AUD weakened
Consolidated - 2021	% change			Effect on profit before tax A$’000			Effect on equity A$’000			% change			Effect on profit before tax A$’000			Effect on equity A$’000
US dollars		10	%		(1,762	)		(1,762	)		(10	%)		1,762			1,762
Euros		10	%		1			1			(10	%)		(1	)		(1	)
					(1,761	)		(1,761	)					1,761			1,761
	AUD strengthened									AUD weakened
Consolidated - 2020	% change			Effect on profit before tax A$’000			Effect on equity A$’000			% change			Effect on profit before tax A$’000			Effect on equity A$’000
US dollars		10	%		192			192			(10	%)		(192	)		(192	)

Price risk

The consolidated entity is not exposed to any significant price risk.

Interest rate risk

The consolidated entity’s exposure to market interest rates relate primarily to the investments of cash balances.

The consolidated entity has cash reserves held primarily in Australian dollars and United States dollars and places funds on deposit with financial institutions for periods generally not exceeding three months.

As at the reporting date, the consolidated entity had the following variable interest rate balances:

	2021					2020
	Weighted average interest rate %			Balance A$’000		Weighted average interest rate %			Balance A$’000
Cash at bank and in hand		0.00	%		21,087		0.04	%		1,264
Short term deposits		0.04	%		6,500		0.95	%		7,500
Net exposure to cash flow interest rate risk					27,587					8,764

The consolidated entity has cash and cash equivalents totalling $27,586,760 (2020: $8,764,044). An official increase/decrease in interest rates of 100 basis points (2020: 100 basis points) would have a favourable/adverse effect on profit before tax and equity of $275,867 (2020 $87,640) per annum. The percentage change is based on the expected volatility of interest rates using market data and analysts forecasts.

Credit risk

Credit risk refers to the risk that a counterparty will default on its contractual obligations resulting in financial loss to the consolidated entity. The entity is not exposed to significant credit risk on receivables.

The consolidated entity has adopted a lifetime expected loss allowance in estimating expected credit losses to trade receivables through the use of a provisions matrix using fixed rates of credit loss provisioning. These provisions are considered representative across all customers of the consolidated entity based on recent sales experience, historical collection rates and forward-looking information that is available.

The consolidated entity places its cash deposits with high credit quality financial institutions and by policy, limits the amount of credit exposure to any single counter-party. The consolidated entity is averse to principal loss and ensures the safety and preservation of its invested funds by limiting default risk, market risk, and reinvestment risk. The consolidated entity mitigates default risk by constantly positioning its portfolio to respond appropriately to a significant reduction in a credit rating of any financial institution.

Generally, trade receivables are written off when there is no reasonable expectation of recovery. Indicators of this include the failure of a debtor to engage in a repayment plan, no active enforcement activity and a failure to make contractual payments for a period greater than 1 year.

There are no significant concentrations of credit risk within the consolidated entity. The credit risk on liquid funds is limited as the counter parties are banks with high credit ratings.

Credit risk is managed by limiting the amount of credit exposure to any single counter-party for cash deposits.

Liquidity risk

The consolidated entity manages liquidity risk by maintaining adequate cash reserves and by continuously monitoring actual and forecast cash flows and matching the maturity profiles of financial assets and liabilities. In particular, contingent consideration may be satisfied either by payment of cash or by issue of shares, at the discretion of the entity. Remaining contractual maturities

The following tables detail the consolidated entity’s remaining contractual maturity for its financial instrument liabilities. The tables have been drawn up based on the undiscounted cash flows of financial liabilities based on the earliest date on which the financial liabilities are required to be paid. The tables include both interest and principal cash flows disclosed as remaining contractual maturities and therefore these totals may differ from their carrying amount in the statement of financial position.

2021	Weighted average interest rate %		1 year or less A$’000		Between 1 and 2 years A$’000		Between 2 and 5 years A$’000		Over 5 years A$’000		Remaining contractual maturities A$’000
Non-derivatives
Non-interest bearing
Trade payables		—		1,893		—		—		—		1,893
Accrued payables		—		3,039		—		—		—		3,039
Contingent consideration		—		3,165		—		9,306		—		12,471
Total non-derivatives				8,097		—		9,306		—		17,403
2020	Weighted average interest rate %		1 year or less A$’000		Between 1 and 2 years A$’000		Between 2 and 5 years A$’000		Over 5 years A$’000		Remaining contractual maturities A$’000
Non-derivatives
Non-interest bearing
Trade payables		—		1,694		—		—		—		1,694
Accrued payables		—		1,795		—		—		—		1,795
Contingent consideration		—				4,199		—		—		4,199
Total non-derivatives				3,489		4,199		—		—		7,688

The cash flows in the maturity analysis above are not expected to occur significantly earlier than contractually disclosed above.

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Fair value measurement

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Fair value measurement

Note 22. Fair value measurement

Fair value hierarchy

The following tables detail the consolidated entity’s assets and liabilities, measured or disclosed at fair value, using a three level hierarchy, based on the lowest level of input that is significant to the entire fair value measurement, being:

Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that the entity can access at the measurement date

Level 2: Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly

Level 3: Unobservable inputs for the asset or liability

Consolidated - 2021	Level 1 A$’000		Level 2 A$’000		Level 3 A$’000		Total A$’000
Liabilities
Contingent Consideration		—		—		1,015		1,015
Total liabilities		—		—		1,015		1,015
Consolidated - 2020
Liabilities
Contingent Consideration		—		—		1,845		1,845
Total liabilities		—		—		1,845		1,845

There were no transfers between levels during the financial year.

The fair value of contingent consideration related to the acquisition of Glioblast Pty Ltd and the licence agreement is estimated by probability-weighting the expected future cash outflows, adjusting for risk and discounting.

The effects on the fair value of risk and uncertainty in the future cash flows are dealt with by adjusting the estimated cash flows rather than adjusting the discount rate. The estimated cashflows were adjusted based on the directors’ assessment of achieving contracted milestones as disclosed in Note 15. The probabilities used fell in the range of 35% to 55% and were informed by generally accepted industry probabilities of drugs achieving certain milestones in their progression towards registration.

Level 3 assets and liabilities

Movements in level 3 assets and liabilities during the current and previous financial year are set out below:

	Level 3 A$’000			Available for sale A$’000		Total A$’000
Consolidated
Balance at 1 July 2019		1,370					1,370
Losses recognised in profit or loss		475			—		475
Balance at 30 June 2020		1,845					1,845
Losses recognised in profit or loss		2,570					2,570
Payout of milestone		(3,400	)				(3,400	)
Balance at 30 June 2021		1,015			—		1,015

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Key management personnel disclosures

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Key management personnel disclosures

Note 23. Key management personnel disclosures

Compensation

The aggregate compensation made to directors and other members of key management personnel (‘KMP’) of the consolidated entity is set out below:

	2021 A$’000		2020 A$’000		2019 A$’000
Short-term employee benefits		1,574		1,324		1,176
Post-employment benefits		112		97		84
Share-based payments		617		230		125
		2,303		1,651		1,385

Please refer to Note 27 for other transactions with key management personnel and their related parties.

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Remuneration of auditors

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Remuneration of auditors

Note 24. Remuneration of auditors

During the financial year the following fees were paid or payable for services provided by Grant Thornton Audit Pty Ltd, the auditor of the consolidated entity:

	Consolidated
	2021 A$’000		2020 A$’000		2019 A$’000
Audit services - Grant Thornton Audit Pty Ltd
Audit or review of the financial statements		151		124		120
		151		124		120

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Contingent liabilities

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Contingent liabilities

Note 25. Contingent liabilities

Other than the contingent consideration set out in note 15, the consolidated entity does not have any other contingent liabilities.

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Commitments

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Commitments

Note 26. Commitments

Lease commitments comprise contracted amounts for leases of premises. The agreement has a duration less than 12 months from financial year end.

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Related party transactions

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Related party transactions

Note 27. Related party transactions

Parent entity

Kazia Therapeutics Limited is the parent entity.

Subsidiaries

Interests in subsidiaries are set out in note 29.

Key management personnel

Disclosures relating to key management personnel are set out in note 23 and the remuneration report included in the directors’ report.

Transactions with related parties

There was no other transaction with KMP and their related parties.

Receivable from and payable to related parties

There were no trade receivables from or trade payables to related parties at the current and previous reporting date.

Loans to/from related parties

There were no loans to or from related parties at the current and previous reporting date.

Terms and conditions

All transactions were made on normal commercial terms and conditions and at market rates.

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Parent entity information

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Parent entity information

Note 28. Parent entity information

Set out below is the supplementary information about the parent entity.

	Parent
	2021 A$’000			2020 A$’000
Statement of profit or loss and other comprehensive income
Loss after income tax		(16,854	)		(11,064	)
Total comprehensive income		(16,854	)		(11,064	)
	2021 A$’000			2020 A$’000
Statement of financial position
Total current assets		25,042			9,703
Total assets		47,044			22,113
Total current liabilities		3,177			1,522
Total liabilities		15,032			5,393
Equity
Contributed equity		80,290			48,781
Other contributed equity		464			464
Reserves		1,754			1,521
Accumulated losses		(50,496	)		(34,046	)
Total equity		32,012			16,720

Reserves comprise Share Based Payments Reserve.

Contingent liabilities

The parent entity contingent liabilities as at 30 June 2021 and 30 June 2020 are as set out in Note 15. The contingent consideration is specific to the parent entity.

Capital commitments - Property, plant and equipment

The parent entity had no capital commitments for property, plant and equipment at as 30 June 2021 and 30 June 2020.

Significant accounting policies

The accounting policies of the parent entity are consistent with those of the consolidated entity, as disclosed in note 2, except for the following:

• Investments in subsidiaries are accounted for at cost, less any impairment, in the parent entity.

• Dividends received from subsidiaries are recognised as other income by the parent entity and its receipt may be an indicator of an impairment of the investment.

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Interests in subsidiaries

12 Months Ended

Jun. 30, 2021

Investments accounted for using equity method [abstract]

Interests in subsidiaries

Note 29. Interests in subsidiaries

The consolidated financial statements incorporate the assets, liabilities and results of the following subsidiaries in accordance with the accounting policy described in note 2:

		Ownership interest
Name	Principal place of business / Country of incorporation	2021 %			2020 %
Kazia Laboratories Pty Ltd	Australia		100.00	%		100.00	%
Kazia Research Pty Ltd	Australia		100.00	%		100.00	%
Kazia Therapeutics Inc.	United States of America		100.00	%		100.00	%
Glioblast Pty Ltd	Australia		100.00	%		100.00	%
Kazia Therapeutics (Hong Kong) Limited	Hong Kong		100.00	%		—

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Reconciliation of loss after income tax to net cash used in operating activities

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Reconciliation of loss after income tax to net cash used in operating activities

Note 30. Reconciliation of loss after income tax to net cash used in operating activities

	2021			2020			2019
	A$’000			A$’000			A$’000
Loss after income tax expense from continuing operations		(8,422	)		(12,467	)		(10,270	)
Adjustments for:
Depreciation & amortisation		1,265			1,084			1,084
Impairment of property, plant & equipment		—			—			1
Net fair value loss on financial assets		—			168			1,809
Share based payments		637			262			246
Foreign exchange differences		430			—			—
Loss on contingent consideration		2,570			474			63
Change in operating assets & liabilities:		(3,521	)		(10,479	)		(7,067	)
Decrease in trade and other receivables		(5,027	)		358			825
Increase in accrued revenue		—			—			(138	)
Decrease/(increase) in prepayments		(1,182	)		(168	)		398
Decrease/(increase) in trade and other payables		1,010			1,722			(409	)
Decrease in deferred tax liability		(484	)		(298	)		(298	)
Increase/(decrease) in other provisions		93			55			(25	)
Net cash used in operating activities		(9,111	)		(8,810	)		(6,714	)

Significant non-cash transactions

During the year the consolidated entity acquired a licensing agreement in relation to the asset EVT801. At year end no portion of the purchase price had been paid and accordingly the transaction does not appear in the cash flow statement.

Furthermore, the consolidated entity issued shares in satisfaction of an acquisition milestone. This transaction did not involve cash and accordingly the transaction does not appear in the cash flow statement.

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Earnings per share

12 Months Ended

Jun. 30, 2021

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Earnings per share

Note 31. Earnings per share

	2021 A$’000			2020 A$’000			2019 A$’000
Loss after income tax attributable to the owners of Kazia Therapeutics Limited		(8,422	)		(12,467	)		(10,270	)
Loss after income tax attributable to the owners of Kazia Therapeutics Limited		(8,422	)		(12,467	)		(10,270	)
	Number			Number			Number
Weighted average number of ordinary shares used in calculating basic earnings per share		117,674,543			73,053,514			57,503,555
Weighted average number of ordinary shares used in calculating Diluted earnings per share		117,674,543			73,053,514			57,503,555
	Cents			Cents			Cents
Basic earnings per share		(7.16	)		(17.07	)		(17.86	)
Diluted earnings per share		(7.16	)		(17.07	)		(17.86	)

1,865,000 unlisted convertible notes with a face value of A$464,000 and 4,446,500 unlisted options have been excluded from the above calculations as they were antidilutive.

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Share-based payments

12 Months Ended

Jun. 30, 2021

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Share-based payments

Note 32. Share-based payments

All of the options set out below have been issued to employees and directors under the ESOP. During the financial year an expense of $636,383 was recognised.

2021

Tranche	Grant date		Expiry date		A$ Exercise price		Balance at the start of the year		Granted		Exercised			Expired/ lapsed on termination of employment			Balance at the end of the year
1		16/11/2015		16/11/2020	$	2.200		236,667		—		—			(236,667	)		—
2		05/09/2016		05/09/2021	$	1.630		50,000		—		—			—			50,000
3		12/10/2016		17/10/2021	$	1.560		62,000		—		—			—			62,000
4		31/10/2016		01/11/2021	$	1.380		12,500		—		—			—			12,500
5		21/11/2016		23/11/2021	$	1.380		50,000		—		—			—			50,000
6		07/08/2017		07/08/2022	$	0.670		224,000		—		(121,500	)		(15,500	)		87,000
7		05/02/2018		05/02/2023	$	0.780		440,000		—		(120,000	)		—			320,000
8		04/01/2019		04/01/2024	$	0.492		250,000		—		(200,000	)		(12,500	)		37,500
9		13/11/2019		04/01/2024	$	0.492		1,200,000		—		—			—			1,200,000
10		13/01/2020		13/01/2025	$	0.881		250,000		—		—			(50,000	)		200,000
11		09/11/2020		13/01/2025	$	1.132		—		1,200,000		—			—			1,200,000
12		09/11/2020		13/01/2025	$	0.881		—		800,000		—			—			800,000
13		04/01/2021		04/01/2025	$	1.690		—		200,000		—			—			200,000
								2,775,167		2,200,000		(441,500	)		(314,667	)		4,219,000
Weighted average exercise price							$	0.797	$	1.090	$	0.620		$	1.850		$	$0.826

No options were forfeited during the year.

At the end of the period the following outstanding options were vested and exercisable:

- Options in tranche 1 have expired during the year

- Options in tranches 2- 8 were vested and exercisable except for tranche 6 which was vested as to 53%

- Options in tranche 9 were vested as to 1million of the 1.2million options on issue

- Options in tranches 10-12 were 25% vested

- Options in tranche 13 were unvested at year end

The weighted average remaining contractual life of options outstanding at the 30 June 2021 is 2.6 years.

2020

Tranche	Grant date		Expiry date		A$ Exercise price		Balance at the start of the year		Granted		Modified			Expired			Balance at the end of the year
1		04/03/2015		16/12/2019	$	1.500		46,647		—		—			(46,647	)		—
2		04/03/2015		18/12/2019	$	1.500		19,952		—		—			(19,952	)		—
3		24/06/2015		30/06/2020	$	4.000		519,000		—		—			(519,000	)		—
4		16/11/2015		16/11/2020	$	2.200		236,667		—		—			—			236,667
5		18/03/2016		01/02/2021	$	1.990		300,000		—		(300,000	)		—			—
6		18/03/2016		01/02/2021	$	1.990		200,000		—		(200,000	)		—			—
7		18/03/2016		01/02/2021	$	2.610		250,000		—		(250,000	)		—			—
8		05/09/2016		05/09/2021	$	1.630		50,000		—		—			—			50,000
9		12/10/2016		17/10/2021	$	1.560		62,000		—		—			—			62,000
10		31/10/2016		01/11/2021	$	1.380		12,500		—		—			—			12,500
11		21/11/2016		23/11/2021	$	1.380		50,000		—		—			—			50,000
12		07/08/2017		07/08/2022	$	0.670		224,000		—		—			—			224,000
13		05/02/2018		05/02/2023	$	0.780		440,000		—		—			—			440,000
14		04/01/2019		04/01/2024	$	0.492		250,000		—		—			—			250,000
15		13/11/2019		04/01/2024	$	0.492		—		—		1,200,000			—			1,200,000
16		13/01/2020		13/01/2025	$	0.881		—		250,000		—			—			250,000
								2,660,766		250,000		450,000			(585,599	)		2,775,167
Weighted average exercise price							$	1.960	$	0.880	$	2.348		$	3.716		$	0.797

At the end of the period the following outstanding options were vested and exercisable:

- Options in tranches 4, 8, 10, 11 and 13 were vested and exercisable

- Options in tranche 16 were unvested

- Options in the other tranches were vested as follows: 9: 75%, 12: 50% 14: 50% and 15: 67%.

All remaining options are expected to vest in future periods.

The weighted average remaining contractual life of options outstanding at the 30 June 2020 is 2.78 years.

Employee share options

During the year ended 30 June 2021, 2,200,000 options have been issued to the employees by the consolidated entity pursuant to the Company’s Employee Share Option Plan.

• Tranche 11 vests in four equal 6-monthly tranches from 1 January 2021

• Tranche 12 vests in four equal annual amounts from 13 January 2021

• Tranche 13 vests in four equal annual tranches from 4 January 2022

Options within all tranches will only vest if the option holder continues to be a full-time employee with the Company or an Associated Company during the vesting period relating to the option.

Conditions for an option to be exercised:

• The option must have vested.

• Option holder must have provided the Company with an Exercise Notice and have paid the Exercise Price for the option.

• The Exercise Notice must be for the exercise of at least the Minimum Number of Options;

• The Exercise Notice must have been provided to the Company and Exercise Price paid before the expiry of 5 years from the date the Option is issued.

Options Valuation

In order to obtain a fair valuation of these options, the following assumptions have been made:

The Black Scholes option valuation methodology has been used with the expectation that the majority of these options would be exercised towards the end of the option term. Inputs into the Black Scholes model includes the share price at grant date, exercise price, volatility, and the risk free rate of a five year Australian Government Bond on grant date.

Risk-free rate and grant date

For all tranches, the risk-free rate of a five-year Australian Government bond on grant date was used. Please refer to the table below for details.

Options in Tranches 1 to 13 have various vesting periods and exercising conditions. These options are unlisted as at 30 June 2021.

No dividends are expected to be declared or paid by the consolidated entity during the terms of the options.

The underlying expected volatility was determined by reference to historical data of the Company’s shares over a period of time.

No special features inherent to the options granted were incorporated into measurement of fair value.

Based on the above assumptions, the table below sets out the valuation for each tranche of options:

Grant date	Expiry date	Share price at Grant Date	Exercise price	Volatility (%)	Remaining Life (years)	Risk free Rate (%)	Fair value per option
05/09/2016	05/09/2021	$0.105	$1.630	122.00%	1.16	1.60%	$0.840
12/10/2016	17/10/2021	$0.098	$1.560	122.00%	1.29	1.89%	$0.780
31/10/2016	01/11/2021	$0.090	$1.380	122.00%	1.20	1.87%	$0.720
21/11/2016	23/11/2021	$0.092	$1.380	122.00%	1.20	2.10%	$0.730
07/08/2017	07/08/2022	$0.430	$0.670	74.50%	2.08	1.95%	$0.206
05/02/2018	05/02/2023	$0.500	$0.780	74.50%	2.58	1.95%	$0.200
04/01/2019	04/01/2024	$0.340	$0.493	74.50%	3.50	1.95%	$0.140
13/11/2019	04/01/2024	$0.410	$0.493	74.50%	4.20	1.95%	$0.180
13/01/2020	13/01/2025	$0.620	$0.881	74.50%	4.50	1.95%	$0.340
09/11/2020	09/11/2024	$0.890	$1.132	90.00%	2.10	0.10%	$0.379
09/11/2020	09/11/2024	$0.890	$1.132	90.00%	2.30	0.10%	$0.403
09/11/2020	09/11/2024	$0.890	$1.132	90.00%	2.60	0.10%	$0.425
09/11/2020	09/11/2024	$0.890	$1.132	90.00%	2.80	0.10%	$0.446
09/11/2020	13/01/2025	$0.890	$0.881	90.00%	2.20	0.10%	$0.450
09/11/2020	13/01/2025	$0.890	$0.881	90.00%	2.70	0.10%	$0.490
09/11/2020	13/01/2025	$0.890	$0.881	90.00%	3.20	0.10%	$0.520
09/11/2020	13/01/2025	$0.890	$0.881	90.00%	3.70	0.10%	$0.550
04/01/2021	04/01/2025	$1.185	$1.169	90.00%	2.50	0.19%	$0.520
04/01/2021	04/01/2025	$1.185	$1.169	90.00%	3.00	0.19%	$0.576
04/01/2021	04/01/2025	$1.185	$1.169	90.00%	3.50	0.19%	$0.627
04/01/2021	04/01/2025	$1.185	$1.169	90.00%	4.00	0.19%	$0.671

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Subsequent events

12 Months Ended

Jun. 30, 2021

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Subsequent events

Note 33. Subsequent events

There were no significant events subsequent to the reporting date.

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Significant accounting policies (Policies)

12 Months Ended

Jun. 30, 2021

Text block [abstract]

New or amended Accounting Standards and Interpretations adopted

New or amended Accounting Standards and Interpretations adopted

The consolidated entity has adopted all of the new, revised or amending Accounting Standards and Interpretations issued by the International Accounting Standards Board (‘IASB’) that are mandatory for the current reporting period.

The adoption of these Accounting Standards and Interpretations did not have any significant impact on the financial performance or position of the consolidated entity. Any new, revised or amending Accounting Standards or Interpretations that are not yet mandatory have not been early adopted.

New Accounting Standards and Interpretations not yet mandatory or early adopted

New Accounting Standards and Interpretations not yet mandatory or early adopted

Australian Accounting Standards and Interpretations that have recently been issued or amended but are not yet mandatory, have not been early adopted by the consolidated entity for the annual reporting period ended 30 June 2021. The consolidated entity’s assessment of the impact of these new or amended Accounting Standards and Interpretations is that none are deemed to have a material impact on the entity.

Going concern

Going concern

The consolidated entity incurred a loss after income tax of $8,421,960 (2020: $12,467,466), was in a net current asset position of $21,064,264(2020: net current asset position of $5,586,128) and had net cash outflows from operating activities of $9,110,516(2020: $8,809,519) for the year ended 30 June 2021.

As at 30 June 2021 the consolidated entity had cash in hand and at bank of $27,586,760.

The financial statements have been prepared on a going concern basis, which contemplates continuity of normal activities and realisation of assets and settlement of liabilities in the normal course of business. As is often the case with drug development companies, the ability of the consolidated entity to continue its development activities as a going concern is dependent upon it deriving sufficient cash from investors, from licensing and partnering activities, and from other sources of revenue such as grant funding.

The directors have considered the cash flow forecasts and the funding requirements of the business and continue to explore grant funding, licensing opportunities and equity investment opportunities in the Company. In particular, the directors have considered the impact of COVID-19 on the operations of the Company, and make the following observations:

• Kazia’s key clinical trials have not been impacted by COVID-19 to date. The GBM Agile study, the pivotal study for paxalisib in glioblastoma, is on track with recruitment running to plan, and no disruption to this schedule is foreseen. The Phase II study of paxalisib in glioblastoma was fully recruited prior to the onset of restrictions and is in wrap up stage at the date of this report. Plans are on track for the commencement of a Phase I trial for EVT801 before the end of 2021;

• In general, clinical research in advanced cancer is relatively protected from pandemic disruption due to the ongoing and time-critical need for patient care in specialised facilities that cannot easily be repurposed;

• The Company is not reliant on ongoing revenue from customers, and so changes in customer behaviour over the next several years due to public health restrictions and reduced economic activity have little to no impact on its finances;

• The Company was able to secure funding of approximately $9 million at the height of the initial wave of COVID-19 in April 2020, and additional funds of approximately $25 million during the 2021 financial year;

• Based on budgets and forecasts, the Company has sufficient cash to fund the operations for a period of at least 12 months from the date of this report; and

• As a consequence the directors do not foresee any other impacts on the Company’s ability to raise additional funding as a result of COVID-19.

Accordingly the directors have prepared the financial statements on a going concern basis. Should the above assumptions not prove to be appropriate, there is material uncertainty whether the consolidated entity will continue as a going concern and therefore whether it will realise its assets and extinguish its liabilities in the normal course of business and at the amounts stated in these financial statements.

Basis of preparation

Basis of preparation

These general purpose financial statements have been prepared in accordance with Australian Accounting Standards and Interpretations issued by the Australian Accounting Standards Board (‘AASB’) and the Corporations Act 2001, as appropriate for for-profit oriented entities. These financial statements also comply with International Financial Reporting Standards as issued by the International Accounting Standards Board (‘IASB’).

The financial statements have been prepared on an accruals basis and under the historical cost conventions, except for listed equity investments which are carried at fair value.

Critical accounting estimates

The preparation of the financial statements requires the use of certain critical accounting estimates. It also requires management to exercise its judgement in the process of applying the consolidated entity’s accounting policies. The areas involving a higher degree of judgement or complexity, or areas where assumptions and estimates are significant to the financial statements, are disclosed in note 3.

Parent entity information

Parent entity information

In accordance with the Corporations Act 2001, these financial statements present the results of the consolidated entity only. Supplementary information about the parent entity is disclosed in note 28.

Principles of consolidation

Principles of consolidation

The consolidated financial statements incorporate the assets and liabilities of all subsidiaries of Kazia Therapeutics Limited (‘company’ or ‘parent entity’) as at 30 June 2021 and the results of all subsidiaries for the year then ended. Kazia Therapeutics Limited and its subsidiaries together are referred to in these financial statements as the ‘consolidated entity’.

Subsidiaries are all those entities over which the consolidated entity has control. The consolidated entity controls an entity when the consolidated entity is exposed to, or has rights to, variable returns from its involvement with the entity and has the ability to affect those returns through its power to direct the activities of the entity. Subsidiaries are fully consolidated from the date on which control is transferred to the consolidated entity. They are de-consolidated from the date that control ceases.

Intercompany transactions, balances and unrealised gains on transactions between entities in the consolidated entity are eliminated. Unrealised losses are also eliminated unless the transaction provides evidence of the impairment of the asset transferred. Accounting policies of subsidiaries have been changed where necessary to ensure consistency with the policies adopted by the consolidated entity.

The acquisition of subsidiaries is accounted for using the acquisition method of accounting. A change in ownership interest, without the loss of control, is accounted for as an equity transaction, where the difference is between the consideration transferred and the book value.

Where the consolidated entity loses control over a subsidiary, it derecognises the assets including goodwill, liabilities and non-controlling interest in the subsidiary together with any cumulative translation differences recognised in equity. The consolidated entity recognises the fair value of the consideration received and the fair value of any investment retained together with any gain or loss in profit or loss.

Operating segments

Operating segments

Operating segments are presented using the ‘management approach’, where the information presented is on the same basis as the internal reports provided to the Chief Operating Decision Makers (‘CODM’). The CODM is responsible for the allocation of resources to operating segments and assessing their performance. The CODM is considered to be the Board of Directors.

Foreign currency translation

Foreign currency translation

The financial statements are presented in Australian dollars, which is the consolidated entity’s functional and presentation currency.

Foreign currency transactions

Foreign currency transactions are translated into Australian dollars using the exchange rates prevailing at the dates of the transactions. Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation at financial year-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognised in profit or loss.

Foreign operations

The assets and liabilities of foreign operations are translated into Australian dollars using the exchange rates at the reporting date. The revenues and expenses of foreign operations are translated into Australian dollars using the average exchange rates, which approximate the rate at the date of the transaction, for the period. All resulting foreign exchange differences are recognised in other comprehensive income through the foreign currency reserve in equity.

The foreign currency reserve is recognised in profit or loss when the foreign operation is disposed of.

Exchange differences arising on a monetary item that forms part of a reporting entity’s net investment in a foreign operation shall be recognised initially in other comprehensive income and reclassified from equity to profit or loss on disposal of the net investment.

Financial instruments

Financial Instruments

Recognition and derecognition

Financial assets and financial liabilities are recognised when the Group becomes a party to the contractual provisions of the financial instrument and are measured initially at fair value adjusted by transactions costs, except for those carried at fair value through profit or loss, which are measured initially at fair value. Subsequent measurement of financial assets and financial liabilities are described below. Financial assets are derecognised when the contractual rights to the cash flows from the financial asset expire, or when the financial asset and substantially all the risks and rewards are transferred. A financial liability is derecognised when it is extinguished, discharged, cancelled or expires.

Classification and initial measurement of financial assets

Except for those trade receivables that do not contain a significant financing component and are measured at the transaction price in accordance with IFRS 15, all financial assets are initially measured at fair value adjusted for transaction costs (where applicable).

Subsequent measurement of financial assets

For the purpose of subsequent measurement, financial assets are classified into the following categories upon initial recognition:

• financial assets at amortised cost

• financial assets at fair value through profit or loss (FVPL)

Classifications are determined by both:

• The entity’s business model for managing the financial asset

• The contractual cash flow characteristics of the financial assets

All income and expenses relating to financial assets that are recognised in profit or loss are presented within finance costs, finance income or other financial items, except for impairment of trade receivables which is presented within other expenses.

Financial assets at amortised cost

Financial assets are measured at amortised cost if the assets meet the following conditions (and are not designated as FVPL):

• they are held within a business model whose objective is to hold the financial assets and collect its contractual cash flows

• the contractual terms of the financial assets give rise to cash flows that are solely payments of principal and interest on the principal amount outstanding

After initial recognition, these are measured at amortised cost using the effective interest method. Discounting is omitted where the effect of discounting is immaterial. The Group’s cash and cash equivalents, trade and most other receivables fall into this category of financial instruments.

Financial assets at fair value through profit or loss (FVPL)

Financial assets that are held within a business model other than ‘hold to collect’ or ‘hold to collect and sell’ are categorised at fair value through profit and loss. Further, irrespective of business model, financial assets whose contractual cash flows are not solely payments of principal and interest are accounted for at FVPL. The Group’s investments in equity instruments and derivatives fall under this category.

Impairment of financial assets

IFRS 9’s new impairment model uses more forward looking information to recognize expected credit losses—the ‘expected credit losses (ECL) model’. The application of the new impairment model depends on whether there has been a significant increase in credit risk. The Group considers a broader range of information when assessing credit risk and measuring expected credit losses, including past events, current conditions, reasonable and supportable forecasts that affect the expected collectability of the future cash flows of the instrument.

In applying this forward-looking approach, a distinction is made between:

• financial instruments that have not deteriorated significantly in credit quality since initial recognition or that have low credit risk (‘Stage 1’) and

• financial instruments that have deteriorated significantly in credit quality since initial recognition and whose credit risk is not low (‘Stage 2’).

‘Stage 3’ would cover financial assets that have objective evidence of impairment at the reporting date. ‘12-month expected credit losses’ are recognised for the first category while ‘lifetime expected credit losses’ are recognised for the second category. Measurement of the expected credit losses is determined by a probability-weighted estimate of credit losses over the expected life of the financial instrument.

Classification and measurement of financial liabilities

The Group’s financial liabilities comprise trade and other payables. Financial liabilities are initially measured at fair value, and, where applicable, adjusted for transaction costs unless the Group designated a financial liability at fair value through profit or loss. Subsequently, financial liabilities are measured at amortised cost using the effective interest method.

All interest-related charges and, if applicable, changes in an instrument’s fair value that are reported in profit or loss are included within finance costs or finance income.

Revenue from contracts with customers

Revenue is measured at the fair value of the consideration received or receivable. Amounts disclosed as revenue are net of returns, trade allowances, rebates and amounts collected on behalf of third parties. Revenue is recognised using a five step approach in accordance with IFRS 15 Revenue from Contracts with Customers to depict the transfer of promised services to customers in an amount that reflects the consideration to which the Group expects to be entitled in exchange for those services. Distinct promises within the contract are identified as performance obligations. The transaction price of the contract is measured based on the amount of consideration the consolidated entity expects to be entitled to from the customer in exchange for services. Factors such as requirements around variable consideration, significant financing components, noncash consideration, or amounts payable to customers also determine the transaction price. The transaction is then allocated to separate performance obligations in the contract based on relative standalone selling prices. Revenue is recognised when, or as, performance obligations are satisfied, which is when control of the promised service is transferred to the customer. Amounts received prior to satisfying the revenue recognition criteria are recorded as deferred revenue. Amounts expected to be recognised as revenue within the 12 months following the balance sheet date are classified within current liabilities. Amounts not expected to be recognised as revenue within the 12 months following the balance sheet date are classified within non-current liabilities.

The consolidated entity recognises contract liabilities for consideration received in respect of unsatisfied performance obligations and reports these amounts as other liabilities in its consolidated statement of financial position. Similarly, if the consolidated entity satisfies a performance obligation before it receives the consideration, the consolidated entity recognises either a contract asset or a receivable in its statement of financial position, depending on whether something other than the passage of time is required before the consideration is due.

Licensing revenues, including milestone revenue

Revenue from licensees of the consolidated entity’s intellectual property reflects the transfer of a right to use the intellectual property as it exists at the point in time in which the licence is transferred to the customer.

Licensing agreements are examined to determine whether they contain additional performance obligations, over and above the right to use the intellectual property. To the extent that additional performance obligations exist, the transaction price the consolidated entity expects to receive for the contract is allocated to the separate performance obligations.

The receipt of milestone payments is often contingent on meeting certain clinical, regulatory or commercial targets, and is therefore considered variable consideration. The transaction price of the contingent milestone is estimated using the most likely amount method. Within the transaction price, the price associated with a contingent milestone is included only to the extent that it is highly probable that a significant reversal in the amount of cumulative revenue recognized will not occur. Milestone payments that are not within the control of the Group, such as regulatory approvals, are not considered highly probable of being achieved until those approvals are achieved.

Finance Income

Interest revenue is recognised as interest accrues using the effective interest method. This is a method of calculating the amortised cost of a financial asset and allocating the interest income over the relevant period using the effective interest rate, which is the rate that exactly discounts estimated future cash receipts through the expected life of the financial asset to the net carrying amount of the financial asset.

Other revenue

Other revenue is recognised when it is received or when the right to receive payment is established.

Grant income

The R&D Tax Incentive is a government program which helps to offset some of the incurred costs of R&D. Eligible expenditure incurred under the scheme in a financial year attracts an additional 43.5% tax deduction, and for a group earning income of less than $20 million, the cash value of the additional deduction is remitted to the taxpayer. In accordance with IAS 20, as the compensation relates to expenses already incurred, it is recognised in profit or loss of the period in which it becomes receivable. Accordingly the group accounts for the R&D Tax Incentive in the same year as the expenses to which it relates.

Income tax

Income tax

The income tax expense or benefit for the period is the tax payable on that period’s taxable income based on the applicable income tax rate for each jurisdiction, adjusted by changes in deferred tax assets and liabilities attributable to temporary differences, unused tax losses and the adjustment recognised for prior periods, where applicable.

Deferred tax assets and liabilities are recognised for temporary differences at the tax rates expected to apply when the assets are recovered or liabilities are settled, based on those tax rates that are enacted or substantively enacted, except for:

• When the deferred income tax asset or liability arises from the initial recognition of goodwill or an asset or liability in a transaction that is not a business combination and that, at the time of the transaction, affects neither the accounting nor taxable profits; or

• When the taxable temporary difference is associated with interests in subsidiaries, associates or joint ventures, and the timing of the reversal can be controlled and it is probable that the temporary difference will not reverse in the foreseeable future.

Deferred tax assets are recognised for deductible temporary differences and unused tax losses only if it is probable that future taxable amounts will be available to utilise those temporary differences and losses.

The carrying amount of recognised and unrecognised deferred tax assets are reviewed each reporting date. Deferred tax assets recognised are reduced to the extent that it is no longer probable that future taxable profits will be available for the carrying amount to be recovered. Previously unrecognised deferred tax assets are recognised to the extent that it is probable that there are future taxable profits available to recover the asset.

Deferred tax assets and liabilities are offset only where there is a legally enforceable right to offset current tax assets against current tax liabilities and deferred tax assets against deferred tax liabilities; and they relate to the same taxable authority on either the same taxable entity or different taxable entities which intend to settle simultaneously.

Kazia Therapeutics Limited (the ‘parent entity’) and its wholly-owned Australian controlled entities have formed an income tax consolidated group under the tax consolidation regime. Kazia Therapeutics Limited as the parent entity discloses all of the deferred tax assets of the tax consolidated group in relation to tax losses carried forward (after elimination of inter-group transactions). The tax consolidated group has applied the ‘separate taxpayer in the group’ allocation approach in determining the appropriate amount of taxes to allocate to members of the tax consolidated group.

As the tax consolidation group continues to generate tax losses there has been no reason for the company to enter a tax funding agreement with members of the tax consolidation group.

Interpretation 23 Uncertain tax positions

Interpretation 23 clarified the application of the recognition and measurement criteria IAS 12 Income Taxes where there is uncertainty over income tax treatments and requires an assessment of each uncertain tax position as to whether it is probable that a taxation authority will accept the position. Where it is not probable, the effect of the uncertainty is reflected in determining the relevant taxable profit or loss, tax bases, unused tax losses and unused tax credits or tax rates. The amount is determined as either the single most likely amount or the sum of the probability weighted amounts in a range of possible outcomes, whichever better predicts the resolution of the uncertainty. Judgments are reassessed as and when new facts and circumstances are presented.

Current and non-current classification

Current and non-current classification

Assets and liabilities are presented in the statement of financial position based on current and non-current classification.

An asset is current when: it is expected to be realised or intended to be sold or consumed in normal operating cycle; it is held primarily for the purpose of trading; it is expected to be realised within 12 months after the reporting period; or the asset is cash or cash equivalent unless restricted from being exchanged or used to settle a liability for at least 12 months after the reporting period. All other assets are classified as non-current.

A liability is current when: it is expected to be settled in normal operating cycle; it is held primarily for the purpose of trading; it is due to be settled within 12 months after the reporting period; or there is no unconditional right to defer the settlement of the liability for at least 12 months after the reporting period. All other liabilities are classified as non-current.

Deferred tax assets and liabilities are always classified as non-current.

Cash and cash equivalents

Cash and cash equivalents

Cash and cash equivalents includes cash on hand, deposits held at call with financial institutions, other short-term, highly liquid investments with original maturities of three months or less that are readily convertible to known amounts of cash and which are subject to an insignificant risk of changes in value.

Research and development

Research and development

Expenditure during the research phase of a project is recognised as an expense when incurred. Development costs are capitalised only when technical feasibility studies identify that the project will deliver future economic benefits and these benefits can be measured reliably.

Leases

Leases

Under IFRS 16, leases are accounted for as follows:

• Right-of-use assets and lease liabilities are recognised in the consolidated statement of financial position, initially measured at the present value of future lease payments;

• Depreciation on right-of-use assets and interest on lease liabilities are recognised in the consolidated statement of profit or loss; and

• The total amount of cash paid under lease arrangements is separated into a principal portion (presented within financing activities) and interest (presented within operating activities) in the consolidated cash flow statement.

Lease incentives under IFRS 16 are recognised as part of the measurement of right-of-use assets and lease liabilities.

Under IFRS 16, right-of-use assets are tested for impairment in accordance with IAS 36 Impairment of assets. This replaces the previous requirement to recognise a provision for onerous lease contracts.

For short-term leases (lease term of 12 months or less) and leases of low-value assets, the consolidated entity has opted to recognise a lease expense on a straight-line basis as permitted by IFRS 16 Leases. This expense is presented within other expenses in the consolidated statement of profit or loss.

Intangible assets

Intangible assets

Intangible assets acquired as part of a business combination, other than goodwill, are initially measured at their fair value at the date of the acquisition. Intangible assets acquired separately are initially recognised at cost. Indefinite life intangible assets are not amortised and are subsequently measured at cost less any impairment. Finite life intangible assets are subsequently measured at cost less amortisation and any impairment. The gains or losses recognised in profit or loss arising from derecognition of intangible assets are measured as the difference between net disposal proceeds and the carrying amount of the intangible asset. The method and useful lives of finite life intangible assets are reviewed annually. Changes in the expected pattern of consumption or useful life are accounted for prospectively by changing the amortisation method or period. Amortisation expense is included in research and development expenditure.

Licensing agreement for paxalisib

The Licensing Agreement asset was initially brought to account at fair value, and is being amortised on a straight-line basis over the period of its expected benefit, being the remaining life of the patent, which was 15 years from the date of acquisition.

Licensing agreement for EVT801

The Licensing agreement asset was initially brought to account at cost and is being amortised on a straight-line basis over the period of its expected benefit, being the remaining life of the patent, which was 12.5 years from the date of acquisition.

Impairment of non-financial assets

Impairment of non-financial assets

Non-financial assets with finite useful lives are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. An impairment loss is recognised for the amount by which the asset’s carrying amount exceeds its recoverable amount.

Recoverable amount is the higher of an asset’s fair value less costs of disposal and value-in-use. The value-in-use is the present value of the estimated future cash flows relating to the asset using a pre-tax discount rate specific to the asset or cash-generating unit to which the asset belongs. Assets that do not have independent cash flows are grouped together to form a cash-generating unit.

Compound financial instruments

Compound financial instruments

Subsequent to initial recognition, the liability component of a compound financial instrument is measured at amortised cost using the effective interest rate method, whereas the equity component is not remeasured. Interest, gains and losses relating to the financial liability are recognised in profit or loss. On conversion, the financial liability is reclassified to equity; no gain or loss is recognised on conversion.

Provisions

Provisions

Provisions are recognised when the consolidated entity has a present (legal or constructive) obligation as a result of a past event, it is probable the consolidated entity will be required to settle the obligation, and a reliable estimate can be made of the amount of the obligation. The amount recognised as a provision is the best estimate of the consideration required to settle the present obligation at the reporting date, taking into account the risks and uncertainties surrounding the obligation. If the time value of money is material, provisions are discounted using a current pre-tax rate specific to the liability. The increase in the provision resulting from the passage of time is recognised as a finance cost.

Employee benefits

Employee benefits

Short-term employee benefits

Liabilities for wages and salaries, including non-monetary benefits, annual leave and long service leave expected to be settled within 12 months of the reporting date are measured at the amounts expected to be paid when the liabilities are settled.

Other long-term employee benefits

The liability for annual leave and long service leave not expected to be settled within 12 months of the reporting date is measured as the present value of expected future payments to be made in respect of services provided by employees up to the reporting date using the projected unit credit method. Consideration is given to expected future wage and salary levels, experience of employee departures and periods of service. Expected future payments are discounted using market yields at the reporting date on high quality corporate bonds with terms to maturity and currency that match, as closely as possible, the estimated future cash outflows.

Defined contribution superannuation expense

Contributions to defined contribution superannuation plans are expensed in the period in which they are incurred.

Share-based payments

Equity-settled share-based compensation benefits are provided to employees under the terms of the Employee Share Option Plan (‘ESOP’) and consultants as compensation for services performed.

Equity-settled transactions are awards of shares, or options over shares that are provided to employees in exchange for the rendering of services.

The cost of equity-settled transactions are measured at fair value on grant date. Fair value is independently determined using the Black-Scholes option pricing model that takes into account the exercise price, the term of the option, the impact of dilution, the share price at grant date and expected price volatility of the underlying share, the expected dividend yield and the risk free interest rate for the term of the option, together with non-vesting conditions that do not determine whether the consolidated entity receives the services that entitle the employees to receive payment. No account is taken of any other vesting conditions.

The cost of equity-settled transactions are recognised as an expense with a corresponding increase in equity over the vesting period. The cumulative charge to profit or loss is calculated based on the grant date fair value of the award, the best estimate of the number of awards that are likely to vest and the expired portion of the vesting period. The amount recognised in profit or loss for the period is the cumulative amount calculated at each reporting date less amounts already recognised in previous periods.

The cumulative charge to profit or loss until settlement of the liability is calculated as follows:

• during the vesting period, the liability at each reporting date is the fair value of the award at that date multiplied by the expired portion of the vesting period.

• from the end of the vesting period until settlement of the award, the liability is the full fair value of the liability at the reporting date.

Market conditions are taken into consideration in determining fair value. Therefore any awards subject to market conditions are considered to vest irrespective of whether or not that market condition has been met, provided all other conditions are satisfied.

If equity-settled awards are modified, as a minimum an expense is recognised as if the modification has not been made. An additional expense is recognised, over the remaining vesting period, for any modification that increases the total fair value of the share-based compensation benefit as at the date of modification.

If the non-vesting condition is within the control of the consolidated entity or employee, the failure to satisfy the condition is treated as a cancellation. If the condition is not within the control of the consolidated entity or employee and is not satisfied during the vesting period, any remaining expense for the award is recognised over the remaining vesting period, unless the award is forfeited.

If equity-settled awards are cancelled, it is treated as if it has vested on the date of cancellation, and any remaining expense is recognised immediately. If a new replacement award is substituted for the cancelled award, the cancelled and new award is treated as if they were a modification.

Finance costs

Finance costs

Finance costs attributable to qualifying assets are capitalised as part of the asset. All other finance costs are expensed in the period in which they are incurred, including interest on short-term and long-term borrowings.

Fair value measurement

Fair value measurement

When an asset or liability, financial or non-financial, is measured at fair value for recognition or disclosure purposes, the fair value is based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date; and assumes that the transaction will take place either: in the principal market; or in the absence of a principal market, in the most advantageous market.

Fair value is measured using the assumptions that market participants would use when pricing the asset or liability, assuming they act in their economic best interest. For non-financial assets, the fair value measurement is based on its highest and best use. Valuation techniques that are appropriate in the circumstances and for which sufficient data are available to measure fair value, are used, maximising the use of relevant observable inputs and minimising the use of unobservable inputs.

Assets and liabilities measured at fair value are classified, into three levels, using a fair value hierarchy that reflects the significance of the inputs used in making the measurements. Classifications are reviewed each reporting date and transfers between levels are determined based on a reassessment of the lowest level input that is significant to the fair value measurement.

For recurring and non-recurring fair value measurements, external valuers may be used when internal expertise is either not available or when the valuation is deemed to be significant. External valuers are selected based on market knowledge and reputation. Where there is a significant change in fair value of an asset or liability from one period to another, an analysis is undertaken, which includes a verification of the major inputs applied in the latest valuation and a comparison, where applicable, with external sources of data.

Issued capital

Issued capital

Ordinary shares are classified as equity.

Incremental costs directly attributable to the issue of new shares or options, including share based payments relating to the issue of shares are, shown in equity as a deduction, net of tax, from the proceeds.

Earnings per share

Earnings per share

Basic earnings per share

Basic earnings per share is calculated by dividing the profit attributable to the owners of Kazia Therapeutics Limited, excluding any costs of servicing equity other than ordinary shares, by the weighted average number of ordinary shares outstanding during the financial year, adjusted for bonus elements in ordinary shares issued during the financial year.

Diluted earnings per share

Diluted earnings per share adjusts the figures used in the determination of basic earnings per share to take into account the after income tax effect of interest and other financing costs associated with dilutive potential ordinary shares and the weighted average number of shares assumed to have been issued for no consideration in relation to dilutive potential ordinary shares.

Goods and Services Tax ('GST') and other similar taxes

Goods and Services Tax (‘GST’) and other similar taxes

Revenues, expenses and assets are recognised net of the amount of associated GST, unless the GST incurred is not recoverable from the tax authority. In this case it is recognised as part of the cost of the acquisition of the asset or as part of the expense.

Receivables and payables are stated inclusive of the amount of GST receivable or payable. The net amount of GST recoverable from, or payable to, the tax authority is included in other receivables or other payables in the statement of financial position.

Cash flows are presented on a gross basis. The GST components of cash flows arising from investing or financing activities which are recoverable from, or payable to the tax authority, are presented as operating cash flows.

Commitments and contingencies are disclosed net of the amount of GST recoverable from, or payable to, the tax authority.

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Revenue (Tables)

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Summary of licensing revenue

	Consolidated
	2021 A$’000		2020 A$’000		2019 A$’000
Licensing revenue		15,183		—		—

Summary of disaggregation of revenue from contracts with customers

The disaggregation of revenue from contracts with customers is as follows:

	Consolidated
	2021 A$’000		2020 A$’000		2019 A$’000
Geographical regions
China		10,006		—		—
Sweden		5,177		—		—
		15,183		—		—
Timing of revenue recognition
Licensing revenue at a point in time		15,183		—		—

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Other income (Tables)

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Summary of other income

	Consolidated
	2021 A$’000		2020 A$’000		2019 A$’000
Net foreign exchange gain		—		5		—
Payroll tax rebate		2		2		—
Subsidies and grants		—		20		9
Reimbursement of expenses		—		—		25
Research and development rebate		—		968		1,431
Other income		2		995		1,465

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Expenses (Tables)

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Summary of expenses

	Consolidated
	2021		2020		2019
	A$’000		A$’000		A$’000
Loss before income tax includes the following specific
Amortisation
Paxalisib licensing agreement		1,084		1,084		1,084
Evotech licensing agreement		181		—		—
Total amortisation		1,265		1,084		1,084
Net foreign exchange loss
Net foreign exchange loss		430		—		18
Rental expense relating to operating leases
Minimum lease payments		93		108		79
Superannuation expense
Defined contribution superannuation expense		138		140		128
Employee benefits expense excluding superannuation
Employee benefits expense excluding superannuation		1,563		1,526		1,396
Other Expenses
Chinese With-Holding Tax incurred on license transaction		931		—		—
Chinese Value Added Tax incurred on license transaction		538		—		—
		1,469		—		—

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Income tax benefit (Tables)

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Summary of income tax benefit

	2021			2020			2019
	A$’000			A$’000			A$’000
Numerical reconciliation of income tax benefit and tax at the statutory rate
Loss before income tax benefit		(8,906	)		(12,765	)		(10,568	)
Tax at the statutory tax rate of 26% (2020 & 2019 27.5%)		(2,316	)		(3,511	)		(2,906	)
Tax effect amounts which are not deductible/(taxable) in calculating taxable income:
Research and Development claim		—			280			394
Amortisation of intangibles		348			298			—
Employee option plan		175			72			67
Gain/loss on revaluation of contingent consideration		707			131			17
		(1,086	)		(2,730	)		(2,428	)
Adjustment to deferred tax balances as a result of change in statutory tax rate		(186	)		—			—
Tax losses and timing differences not recognised		788			2,432			2,130
Income tax benefit		(484	)		(298	)		(298	)
	2021			2020			2019
	A$’000			A$’000			A$’000
Tax losses not recognised
Unused tax losses for which no deferred tax asset has been recognised-Australia		70,896			67,430			57,050
Potential tax benefit @ 26.0% (2020 27.5%)- Australia		18,433			17,531			15,689
Unused tax losses for which no deferred tax asset has been recognised-US		2,038			1,570			2,366
Potential tax benefit at statutory tax rates@21%-US		428			330			497

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Current assets - cash and cash equivalents (Tables)

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Summary of cash and cash equivalents

	2021		2020
	A$’000		A$’000
Cash at bank and on hand		21,087		1,264
Short-term deposits		6,500		7,500
		27,587		8,764

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Trade and other receivables (Tables)

12 Months Ended

Jun. 30, 2021

Statement [line items]

Summary of current assets - trade and other receivables

	2021		2020
	A$’000		A$’000
Current assets
R&D tax rebate receivable		—		1,017
		—		1,017
Other receivables		76		177
Deposits held		8		567
Less: Provision for impairment of deposits held		—		(409	)
		84		1,352
Non-current assets
Deposit paid		6,694
		6,778		1,352

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Other Assets (Tables)

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Summary of current assets - other

Current assets

	2021		2020
	A$’000		A$’000
Prepayments		1,720		537

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Intangibles (Tables)

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Summary of non-current assets - intangibles

	Consolidated
	2021			2020
	A$’000			A$’000
Licensing agreement - at acquired fair value		16,408			16,408
Less: Accumulated amortisation		(5,082	)		(3,998	)
		11,326			12,410
Licensing agreement - at cost		10,858			—
Less: Accumulated amortisation		(181	)		—
		10,677			12,410
		22,003			12,410

Summary of reconciliations of intangibles

Reconciliations of the written down values at the beginning and end of the current and previous financial year are set out below:

	EVT801 licensing agreement A$’000			Paxalisib licensing agreement A$’000			Total A$’000
Balance at 1 July 2019		—			13,494			13,494
Additions
Disposals
Amortisation expense		—			(1,084	)		(1,084	)
Balance at 30 June 2020		—			12,410			12,410
Additions		10,858						10,858
Amortisation expense		(181	)		(1,084	)		(1,265	)
Balance at 30 June 2021		10,677			11,326			22,003

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Trade and other payables (Tables)

12 Months Ended

Jun. 30, 2021

1 year or less [member]

Statement [line items]

Summary of trade and other payables

	2021		2020
	A$’000		A$’000
Trade payables		1,893		1,694
Accrued payables		3,040		1,795
		4,933		3,489

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Employee benefits (Tables)

12 Months Ended

Jun. 30, 2021

1 year or less [member]

Statement [line items]

Summary of provisions

	2021		2020
	A$’000		A$’000
Current Liabilities
Employee benefits		229		191
Non-Current Liabilities
Long service leave		55		—
		284		191

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Contingent consideration (Tables)

12 Months Ended

Jun. 30, 2021

Later than one year [member]

Statement [line items]

Summary of liabilities - contingent consideration

	2021 A$’000		2020 A$’000
Current Liabilities
Contingent consideration - paxalisib		—		1,387
Contingent consideration – EVT801		3,165		—
		3,165		1,387
Non-current Liabilities
Contingent consideration - paxalisib		1,015		458
Contingent consideration – EVT801		7,911		—
		8,927		458
		12,091		1,845

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Deferred tax (Tables)

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Summary of non-current liabilities - deferred tax

	2021		2020
	A$’000		A$’000
Non-current Liabilities
Deferred tax liability associated with Licensing Agreement		2,928		3,413

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Equity - contributed equity (Tables)

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Summary of equity - contributed equity

	Consolidated
	2021 Shares		2020 Shares		2021 $		2020 $
Ordinary shares - fully paid		132,012,209		94,598,369		80,290,062		48,781,214

Summary of movements in ordinary share capital

Movements in Ordinary share capital

Details	Date	Shares		Issue price		$
Balance	1 July 2019		62,166,673				36,641,519
Share placement	1 November 2019		10,000,000	$	0.400		4,000,000
Share placement	16 April 2020		18,041,667	$	0.400		7,216,667
Issued under the Share Purchase Plan	11 May 2020		4,390,010	$	0.400		1,756,004
Issued on conversion of options			19	$	4.000		76
Share issue transaction costs			—	$	0.000		(833,052	)
Balance	30 June 2020		94,598,369				48,781,214
Issued on conversion of options	28 August 2020		25,000	$	0.493		12,313
Institutional placement under ANREO	12 October 2020		20,525,820	$	0.800		16,420,656
Retail placement under ANREO	26 October 2020		11,017,075	$	0.800		8,813,660
Issued on conversion of options	2 March 2021		391,500	$	0.635		248,661
Issued on conversion of options	15 March 2021		25,000	$	0.493		12,313
Share placement	28 April 2021		3,037,580	$	1.407		4,274,633
Issued on achievement of a milestone	21 May 2021		2,391,865	$	1.421		3,400,000
Less: share issue transaction costs			—	$	0.000		(1,673,388	)
Balance	30 June 2021		132,012,209				80,290,062

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Equity - Other contributed equity (Tables)

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Summary of equity - other contributed equity

	2021		2020
	$		$
Convertible note - Triaxial		464,000		464,000

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Financial instruments (Tables)

12 Months Ended

Jun. 30, 2021

Statement [line items]

Summary of foreign currency risk

The carrying amount of the consolidated entity’s foreign currency denominated financial assets and financial liabilities at the reporting date was as follows:

	Assets				Liabilities
	2021		2020		2021		2020
	A$’000		A$’000		A$’000		A$’000
US dollars		21,073		272		3,448		2,196
Euros		—		—		16		—
		21,073		272		3,464		2,196

Summary of foreign currency risk sensitivity

If the AUD had strengthened against the USD by 10% (2020: 10%) then this would have had the following impact:

	AUD strengthened									AUD weakened
Consolidated - 2021	% change			Effect on profit before tax A$’000			Effect on equity A$’000			% change			Effect on profit before tax A$’000			Effect on equity A$’000
US dollars		10	%		(1,762	)		(1,762	)		(10	%)		1,762			1,762
Euros		10	%		1			1			(10	%)		(1	)		(1	)
					(1,761	)		(1,761	)					1,761			1,761
	AUD strengthened									AUD weakened
Consolidated - 2020	% change			Effect on profit before tax A$’000			Effect on equity A$’000			% change			Effect on profit before tax A$’000			Effect on equity A$’000
US dollars		10	%		192			192			(10	%)		(192	)		(192	)

Summary of variable interest rate balances

As at the reporting date, the consolidated entity had the following variable interest rate balances:

	2021					2020
	Weighted average interest rate %			Balance A$’000		Weighted average interest rate %			Balance A$’000
Cash at bank and in hand		0.00	%		21,087		0.04	%		1,264
Short term deposits		0.04	%		6,500		0.95	%		7,500
Net exposure to cash flow interest rate risk					27,587					8,764

Summary of remaining contractual maturities of financial instrument liabilities

2021	Weighted average interest rate %		1 year or less A$’000		Between 1 and 2 years A$’000		Between 2 and 5 years A$’000		Over 5 years A$’000		Remaining contractual maturities A$’000
Non-derivatives
Non-interest bearing
Trade payables		—		1,893		—		—		—		1,893
Accrued payables		—		3,039		—		—		—		3,039
Contingent consideration		—		3,165		—		9,306		—		12,471
Total non-derivatives				8,097		—		9,306		—		17,403
2020	Weighted average interest rate %		1 year or less A$’000		Between 1 and 2 years A$’000		Between 2 and 5 years A$’000		Over 5 years A$’000		Remaining contractual maturities A$’000
Non-derivatives
Non-interest bearing
Trade payables		—		1,694		—		—		—		1,694
Accrued payables		—		1,795		—		—		—		1,795
Contingent consideration		—				4,199		—		—		4,199
Total non-derivatives				3,489		4,199		—		—		7,688

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Fair value measurement (Tables)

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Summary of assets and liabilities, measured or disclosed at fair value

The following tables detail the consolidated entity’s assets and liabilities, measured or disclosed at fair value, using a three level hierarchy, based on the lowest level of input that is significant to the entire fair value measurement, being:

Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that the entity can access at the measurement date

Level 2: Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly

Level 3: Unobservable inputs for the asset or liability

Consolidated - 2021	Level 1 A$’000		Level 2 A$’000		Level 3 A$’000		Total A$’000
Liabilities
Contingent Consideration		—		—		1,015		1,015
Total liabilities		—		—		1,015		1,015
Consolidated - 2020
Liabilities
Contingent Consideration		—		—		1,845		1,845
Total liabilities		—		—		1,845		1,845

Summary of movements in level 3 assets and liabilities

Movements in level 3 assets and liabilities during the current and previous financial year are set out below:

	Level 3 A$’000			Available for sale A$’000		Total A$’000
Consolidated
Balance at 1 July 2019		1,370					1,370
Losses recognised in profit or loss		475			—		475
Balance at 30 June 2020		1,845					1,845
Losses recognised in profit or loss		2,570					2,570
Payout of milestone		(3,400	)				(3,400	)
Balance at 30 June 2021		1,015			—		1,015

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Key management personnel disclosures (Tables)

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Summary of compensation made to directors and other members of key management personnel

The aggregate compensation made to directors and other members of key management personnel (‘KMP’) of the consolidated entity is set out below:

	2021 A$’000		2020 A$’000		2019 A$’000
Short-term employee benefits		1,574		1,324		1,176
Post-employment benefits		112		97		84
Share-based payments		617		230		125
		2,303		1,651		1,385

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Remuneration of auditors (Tables)

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Summary of remuneration of auditors

During the financial year the following fees were paid or payable for services provided by Grant Thornton Audit Pty Ltd, the auditor of the consolidated entity:

	Consolidated
	2021 A$’000		2020 A$’000		2019 A$’000
Audit services - Grant Thornton Audit Pty Ltd
Audit or review of the financial statements		151		124		120
		151		124		120

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Parent entity information (Tables)

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Parent entity financial information

Set out below is the supplementary information about the parent entity.

	Parent
	2021 A$’000			2020 A$’000
Statement of profit or loss and other comprehensive income
Loss after income tax		(16,854	)		(11,064	)
Total comprehensive income		(16,854	)		(11,064	)
	2021 A$’000			2020 A$’000
Statement of financial position
Total current assets		25,042			9,703
Total assets		47,044			22,113
Total current liabilities		3,177			1,522
Total liabilities		15,032			5,393
Equity
Contributed equity		80,290			48,781
Other contributed equity		464			464
Reserves		1,754			1,521
Accumulated losses		(50,496	)		(34,046	)
Total equity		32,012			16,720

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Interests in subsidiaries (Tables)

12 Months Ended

Jun. 30, 2021

Investments accounted for using equity method [abstract]

Summary of interest in subsidiaries

The consolidated financial statements incorporate the assets, liabilities and results of the following subsidiaries in accordance with the accounting policy described in note 2:

		Ownership interest
Name	Principal place of business / Country of incorporation	2021 %			2020 %
Kazia Laboratories Pty Ltd	Australia		100.00	%		100.00	%
Kazia Research Pty Ltd	Australia		100.00	%		100.00	%
Kazia Therapeutics Inc.	United States of America		100.00	%		100.00	%
Glioblast Pty Ltd	Australia		100.00	%		100.00	%
Kazia Therapeutics (Hong Kong) Limited	Hong Kong		100.00	%		—

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Reconciliation of loss after income tax to net cash used in operating activities (Tables)

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Disclosure of reconciliation of profit or loss to operating cash flows

	2021			2020			2019
	A$’000			A$’000			A$’000
Loss after income tax expense from continuing operations		(8,422	)		(12,467	)		(10,270	)
Adjustments for:
Depreciation & amortisation		1,265			1,084			1,084
Impairment of property, plant & equipment		—			—			1
Net fair value loss on financial assets		—			168			1,809
Share based payments		637			262			246
Foreign exchange differences		430			—			—
Loss on contingent consideration		2,570			474			63
Change in operating assets & liabilities:		(3,521	)		(10,479	)		(7,067	)
Decrease in trade and other receivables		(5,027	)		358			825
Increase in accrued revenue		—			—			(138	)
Decrease/(increase) in prepayments		(1,182	)		(168	)		398
Decrease/(increase) in trade and other payables		1,010			1,722			(409	)
Decrease in deferred tax liability		(484	)		(298	)		(298	)
Increase/(decrease) in other provisions		93			55			(25	)
Net cash used in operating activities		(9,111	)		(8,810	)		(6,714	)

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Earnings per share (Tables)

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Summary of earnings per share

	2021 A$’000			2020 A$’000			2019 A$’000
Loss after income tax attributable to the owners of Kazia Therapeutics Limited		(8,422	)		(12,467	)		(10,270	)
Loss after income tax attributable to the owners of Kazia Therapeutics Limited		(8,422	)		(12,467	)		(10,270	)
	Number			Number			Number
Weighted average number of ordinary shares used in calculating basic earnings per share		117,674,543			73,053,514			57,503,555
Weighted average number of ordinary shares used in calculating Diluted earnings per share		117,674,543			73,053,514			57,503,555
	Cents			Cents			Cents
Basic earnings per share		(7.16	)		(17.07	)		(17.86	)
Diluted earnings per share		(7.16	)		(17.07	)		(17.86	)

XML

Share-based payments (Tables)

12 Months Ended

Jun. 30, 2021

Text block [abstract]

Summary of share-based payments

All of the options set out below have been issued to employees and directors under the ESOP. During the financial year an expense of $636,383 was recognised.

2021

Tranche	Grant date		Expiry date		A$ Exercise price		Balance at the start of the year		Granted		Exercised			Expired/ lapsed on termination of employment			Balance at the end of the year
1		16/11/2015		16/11/2020	$	2.200		236,667		—		—			(236,667	)		—
2		05/09/2016		05/09/2021	$	1.630		50,000		—		—			—			50,000
3		12/10/2016		17/10/2021	$	1.560		62,000		—		—			—			62,000
4		31/10/2016		01/11/2021	$	1.380		12,500		—		—			—			12,500
5		21/11/2016		23/11/2021	$	1.380		50,000		—		—			—			50,000
6		07/08/2017		07/08/2022	$	0.670		224,000		—		(121,500	)		(15,500	)		87,000
7		05/02/2018		05/02/2023	$	0.780		440,000		—		(120,000	)		—			320,000
8		04/01/2019		04/01/2024	$	0.492		250,000		—		(200,000	)		(12,500	)		37,500
9		13/11/2019		04/01/2024	$	0.492		1,200,000		—		—			—			1,200,000
10		13/01/2020		13/01/2025	$	0.881		250,000		—		—			(50,000	)		200,000
11		09/11/2020		13/01/2025	$	1.132		—		1,200,000		—			—			1,200,000
12		09/11/2020		13/01/2025	$	0.881		—		800,000		—			—			800,000
13		04/01/2021		04/01/2025	$	1.690		—		200,000		—			—			200,000
								2,775,167		2,200,000		(441,500	)		(314,667	)		4,219,000
Weighted average exercise price							$	0.797	$	1.090	$	0.620		$	1.850		$	$0.826

No options were forfeited during the year.

At the end of the period the following outstanding options were vested and exercisable:

- Options in tranche 1 have expired during the year

- Options in tranches 2- 8 were vested and exercisable except for tranche 6 which was vested as to 53%

- Options in tranche 9 were vested as to 1million of the 1.2million options on issue

- Options in tranches 10-12 were 25% vested

- Options in tranche 13 were unvested at year end

The weighted average remaining contractual life of options outstanding at the 30 June 2021 is 2.6 years.

2020

Tranche	Grant date		Expiry date		A$ Exercise price		Balance at the start of the year		Granted		Modified			Expired			Balance at the end of the year
1		04/03/2015		16/12/2019	$	1.500		46,647		—		—			(46,647	)		—
2		04/03/2015		18/12/2019	$	1.500		19,952		—		—			(19,952	)		—
3		24/06/2015		30/06/2020	$	4.000		519,000		—		—			(519,000	)		—
4		16/11/2015		16/11/2020	$	2.200		236,667		—		—			—			236,667
5		18/03/2016		01/02/2021	$	1.990		300,000		—		(300,000	)		—			—
6		18/03/2016		01/02/2021	$	1.990		200,000		—		(200,000	)		—			—
7		18/03/2016		01/02/2021	$	2.610		250,000		—		(250,000	)		—			—
8		05/09/2016		05/09/2021	$	1.630		50,000		—		—			—			50,000
9		12/10/2016		17/10/2021	$	1.560		62,000		—		—			—			62,000
10		31/10/2016		01/11/2021	$	1.380		12,500		—		—			—			12,500
11		21/11/2016		23/11/2021	$	1.380		50,000		—		—			—			50,000
12		07/08/2017		07/08/2022	$	0.670		224,000		—		—			—			224,000
13		05/02/2018		05/02/2023	$	0.780		440,000		—		—			—			440,000
14		04/01/2019		04/01/2024	$	0.492		250,000		—		—			—			250,000
15		13/11/2019		04/01/2024	$	0.492		—		—		1,200,000			—			1,200,000
16		13/01/2020		13/01/2025	$	0.881		—		250,000		—			—			250,000
								2,660,766		250,000		450,000			(585,599	)		2,775,167
Weighted average exercise price							$	1.960	$	0.880	$	2.348		$	3.716		$	0.797

At the end of the period the following outstanding options were vested and exercisable:

- Options in tranches 4, 8, 10, 11 and 13 were vested and exercisable

- Options in tranche 16 were unvested

- Options in the other tranches were vested as follows: 9: 75%, 12: 50% 14: 50% and 15: 67%.

All remaining options are expected to vest in future periods.

The weighted average remaining contractual life of options outstanding at the 30 June 2020 is 2.78 years.

Summary of valuation for each tranche of options

Based on the above assumptions, the table below sets out the valuation for each tranche of options:

Grant date	Expiry date	Share price at Grant Date	Exercise price	Volatility (%)	Remaining Life (years)	Risk free Rate (%)	Fair value per option
05/09/2016	05/09/2021	$0.105	$1.630	122.00%	1.16	1.60%	$0.840
12/10/2016	17/10/2021	$0.098	$1.560	122.00%	1.29	1.89%	$0.780
31/10/2016	01/11/2021	$0.090	$1.380	122.00%	1.20	1.87%	$0.720
21/11/2016	23/11/2021	$0.092	$1.380	122.00%	1.20	2.10%	$0.730
07/08/2017	07/08/2022	$0.430	$0.670	74.50%	2.08	1.95%	$0.206
05/02/2018	05/02/2023	$0.500	$0.780	74.50%	2.58	1.95%	$0.200
04/01/2019	04/01/2024	$0.340	$0.493	74.50%	3.50	1.95%	$0.140
13/11/2019	04/01/2024	$0.410	$0.493	74.50%	4.20	1.95%	$0.180
13/01/2020	13/01/2025	$0.620	$0.881	74.50%	4.50	1.95%	$0.340
09/11/2020	09/11/2024	$0.890	$1.132	90.00%	2.10	0.10%	$0.379
09/11/2020	09/11/2024	$0.890	$1.132	90.00%	2.30	0.10%	$0.403
09/11/2020	09/11/2024	$0.890	$1.132	90.00%	2.60	0.10%	$0.425
09/11/2020	09/11/2024	$0.890	$1.132	90.00%	2.80	0.10%	$0.446
09/11/2020	13/01/2025	$0.890	$0.881	90.00%	2.20	0.10%	$0.450
09/11/2020	13/01/2025	$0.890	$0.881	90.00%	2.70	0.10%	$0.490
09/11/2020	13/01/2025	$0.890	$0.881	90.00%	3.20	0.10%	$0.520
09/11/2020	13/01/2025	$0.890	$0.881	90.00%	3.70	0.10%	$0.550
04/01/2021	04/01/2025	$1.185	$1.169	90.00%	2.50	0.19%	$0.520
04/01/2021	04/01/2025	$1.185	$1.169	90.00%	3.00	0.19%	$0.576
04/01/2021	04/01/2025	$1.185	$1.169	90.00%	3.50	0.19%	$0.627
04/01/2021	04/01/2025	$1.185	$1.169	90.00%	4.00	0.19%	$0.671

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Significant accounting policies - Additional Information (Detail) - AUD ($)	1 Months Ended	12 Months Ended
	Apr. 30, 2020	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2019	Jun. 30, 2018
Disclosure of summary of significant accounting policies [line items]
Consolidated loss after income tax		$ 8,421,960	$ 12,467,466	$ 10,270,000
Net current asset position		21,064,264	5,586,128
Net cash outflows from operating activities		9,111,000	8,810,000	6,714,000
Consolidated cash in hand and at bank		27,586,760	$ 8,764,044	$ 5,434,000	$ 5,956,000
Clinical Trials [Member] | Covid Ninteen [Member]
Disclosure of summary of significant accounting policies [line items]
Proceeds from funding for project purpose	$ 9,000,000	$ 25,000,000
Research and development tax incentive program [member]
Disclosure of summary of significant accounting policies [line items]
Additional tax deduction percentage		43.50%
Top of range [member] | Research and development tax incentive program [member]
Disclosure of summary of significant accounting policies [line items]
Earning income		$ 20,000,000
Licensing agreement for paxalisib [member]
Disclosure of summary of significant accounting policies [line items]
Remaining useful life,licensing agreement		15 years
Licensing agreement for EVT801 [member]
Disclosure of summary of significant accounting policies [line items]
Remaining useful life,licensing agreement		12.5 years

XML

Critical Accounting Judgements, Estimates and Assumptions - Additional Information (Detail)	12 Months Ended
	Jun. 30, 2021
Disclosure of significant accounting judgments assumptions and estimates [abstract]
Percentage milestone trigger to account cost of asset conferred under license agreement	50.00%

XML

Operating segments - Additional Information (Detail)	12 Months Ended
	Jun. 30, 2021 Major_Customer Segments
Disclosure of operating segments [abstract]
Number of operating segments | Segments	0
Number of major customers | Major_Customer	2
Concentration risk major customer percentage	10.00%

XML

Revenue - Summary of licensing revenue (Detail) - AUD ($) $ in Thousands	12 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2019
Disclosure of products and services [line items]
Revenue from contracts with customers	$ 15,183
Licensing revenue [Member]
Disclosure of products and services [line items]
Revenue from contracts with customers	$ 15,183

XML

Revenue - Summary of disaggregation of revenue from contracts with customers (Detail) - AUD ($) $ in Thousands	12 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2019
Disclosure of disaggregation of revenue from contracts with customers [line items]
Revenue from contracts with customers	$ 15,183
Licensing revenue [Member]
Disclosure of disaggregation of revenue from contracts with customers [line items]
Revenue from contracts with customers	15,183
Licensing revenue [Member] | Timing of revenue recognition [member]
Disclosure of disaggregation of revenue from contracts with customers [line items]
Revenue from contracts with customers	15,183
China [member]
Disclosure of disaggregation of revenue from contracts with customers [line items]
Revenue from contracts with customers	10,006
Swedan [member]
Disclosure of disaggregation of revenue from contracts with customers [line items]
Revenue from contracts with customers	$ 5,177

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Other income - Summary of other income (Detail) - AUD ($) $ in Thousands	12 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2019
Material income and expense [abstract]
Net foreign exchange gain		$ 5
Payroll tax rebate	2	2
Subsidies and grants		20	9
Reimbursement of expenses			25
Research and development rebate		968	1,431
Other income	$ 2	$ 995	$ 1,465

XML

Expenses - Summary of expenses (Detail) - AUD ($) $ in Thousands	12 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2019
Loss before income tax includes the following specific
Amortisation	$ 1,265	$ 1,084	$ 1,084
Net foreign exchange loss	430		18
Minimum lease payments	93	108	79
Defined contribution superannuation expense	138	140	128
Employee benefits expense excluding superannuation	1,563	1,526	1,396
Chinese With-Holding Tax incurred on license transaction	931
Chinese Value Added Tax incurred on license transaction	538
Total Expenses	1,469
Paxalisib licensing agreement [member]
Loss before income tax includes the following specific
Amortisation	1,084	$ 1,084	$ 1,084
Evotech Licensing Agreement [member]
Loss before income tax includes the following specific
Amortisation	$ 181

XML

Income tax benefit - Summary of Income tax benefit (Detail) - AUD ($) $ in Thousands	12 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2019
Numerical reconciliation of income tax benefit and tax at the statutory rate
Loss before income tax benefit	$ (8,906)	$ (12,765)	$ (10,568)
Tax at the statutory tax rate of 26% (2020 & 2019 27.5%)	(2,316)	(3,511)	(2,906)
Tax effect amounts which are not deductible/(taxable) in calculating taxable income:
Research and Development claim		280	394
Amortisation of intangibles	348	298
Employee option plan	175	72	67
Gain/loss on revaluation of contingent consideration	707	131	17
Prior year tax losses not recognised now recouped	(1,086)	(2,730)	(2,428)
Adjustment to deferred tax balances as a result of change in statutory tax rate	(186)
Tax losses and timing differences not recognised	788	2,432	2,130
Income tax benefit	(484)	(298)	(298)
Australia [member]
Tax losses not recognised
Unused tax losses for which no deferred tax asset has been recognised	70,896	67,430	57,050
Potential tax benefit	18,433	17,531	15,689
US [member]
Tax losses not recognised
Unused tax losses for which no deferred tax asset has been recognised	2,038	1,570	2,366
Potential tax benefit	$ 428	$ 330	$ 497

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Income tax benefit - Summary of Income tax benefit (Parenthetical) (Detail)	12 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2019
Disclosure Of Income Tax Benefit [line items]
Statutory tax rate	26.00%	27.50%	27.50%
Australia [member]
Disclosure Of Income Tax Benefit [line items]
Statutory tax rate	26.00%	27.50%	27.50%
US [member]
Disclosure Of Income Tax Benefit [line items]
Statutory tax rate	21.00%	21.00%	21.00%

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Current assets - cash and cash equivalents - Summary of cash and cash equivalents (Detail) - AUD ($)	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2019	Jun. 30, 2018
Cash and cash equivalents [abstract]
Cash at bank and on hand	$ 21,087,000	$ 1,264,000
Short-term deposits	6,500,000	7,500,000
Cash and cash equivalents	$ 27,586,760	$ 8,764,044	$ 5,434,000	$ 5,956,000

XML

Trade and other receivables - Summary of current assets - trade and other receivables (Detail) - AUD ($) $ in Thousands	Jun. 30, 2021	Jun. 30, 2020
Disclosure of financial assets [line items]
R&D tax rebate receivable		$ 1,017
Trade and other current receivables	$ 84	1,352
Deposit paid	6,694
Trade and other receivables	6,778	1,352
Gross carrying amount [member]
Disclosure of financial assets [line items]
Other receivables	76	177
Provision for impairment [member]
Disclosure of financial assets [line items]
Other receivables		(409)
R&D tax rebate receivable [member]
Disclosure of financial assets [line items]
R&D tax rebate receivable		1,017
Deposits held [member]
Disclosure of financial assets [line items]
Other receivables	$ 8	$ 567

XML

Trade and other receivables - Additional Information (Detail) $ in Thousands	Jun. 30, 2021 AUD ($)
Trade and other receivables [abstract]
Deposit paid as advance	$ 6,650

XML

Other assets - Summary of current assets - other (Detail) - AUD ($) $ in Thousands	Jun. 30, 2021	Jun. 30, 2020
Statement of financial position [abstract]
Prepayments	$ 1,720	$ 537

XML

Intangibles - Summary of non-current assets - intangibles (Detail) - AUD ($) $ in Thousands	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2019
Disclosure of detailed information about intangible assets [line items]
Intangibles	$ 22,003	$ 12,410	$ 13,494
GDC licensing agreement [member]
Disclosure of detailed information about intangible assets [line items]
Intangibles	11,326	12,410
GDC licensing agreement [member] | Gross carrying amount [member]
Disclosure of detailed information about intangible assets [line items]
Intangibles	16,408	16,408
GDC licensing agreement [member] | Accumulated depreciation and amortisation [member]
Disclosure of detailed information about intangible assets [line items]
Intangibles	(5,082)	(3,998)
Licensing Agreement [Member]
Disclosure of detailed information about intangible assets [line items]
Intangibles	10,677	$ 12,410
Licensing Agreement [Member] | Gross carrying amount [member]
Disclosure of detailed information about intangible assets [line items]
Intangibles	10,858
Licensing Agreement [Member] | Accumulated depreciation and amortisation [member]
Disclosure of detailed information about intangible assets [line items]
Intangibles	$ (181)

XML

Intangibles - Summary of reconciliations of intangibles (Detail) - AUD ($) $ in Thousands	12 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2019
Disclosure of detailed information about intangible assets [line items]
Beginning balance	$ 12,410	$ 13,494
Additions	10,858
Amortisation expense	(1,265)	(1,084)	$ (1,084)
Ending balance	22,003	12,410	13,494
Paxalisib licensing agreement [member]
Disclosure of detailed information about intangible assets [line items]
Beginning balance	12,410	13,494
Amortisation expense	(1,084)	(1,084)	(1,084)
Ending balance	11,326	$ 12,410	$ 13,494
EVT801 licensing agreement [Member]
Disclosure of detailed information about intangible assets [line items]
Additions	10,858
Amortisation expense	(181)
Ending balance	$ 10,677

XML

Trade and other payables - Summary of current liabilities - trade and other payables (Detail) - AUD ($) $ in Thousands	Jun. 30, 2021	Jun. 30, 2020
Trade and other payables [abstract]
Trade payables	$ 1,893	$ 1,694
Accrued payables	3,040	1,795
Total trade and other payables	$ 4,933	$ 3,489

XML

Employee benefits - Summary of provision (Detail) - AUD ($) $ in Thousands	Jun. 30, 2021	Jun. 30, 2020
Disclosure of defined benefit plans [abstract]
Employee benefits	$ 229	$ 191
Long service leave	55
Provisions for employee benefits	$ 284	$ 191

XML

Contingent consideration - Summary of liabilities - contingent consideration (Detail) - AUD ($) $ in Thousands	Jun. 30, 2021	Jun. 30, 2020
Disclosure of contingent liabilities [line items]
Contingent Consideration Current	$ 3,165	$ 1,387
Contingent consideration	8,927	458
Contingent Consideration	12,091	1,845
Contingent consideration - paxalisib
Disclosure of contingent liabilities [line items]
Contingent Consideration Current		1,387
Contingent consideration	1,015	$ 458
Contingent consideration – EVT801
Disclosure of contingent liabilities [line items]
Contingent Consideration Current	3,165
Contingent consideration	$ 7,911

XML

Contingent consideration - Additional Information (Detail)	12 Months Ended
	Jun. 30, 2021 AUD ($) Milestone	Jun. 30, 2021 EUR (€) Milestone	Jun. 30, 2020	Jun. 30, 2017
Disclosure of contingent liabilities [line items]
Milestone payment payable | $	$ 1,394,000
Milestone payments not booked	$ 475,474,684	€ 300,500,000
Milestone payment discount rate	15.00%	15.00%	35.00%
Glioblast Pty Ltd [member]
Disclosure of contingent liabilities [line items]
Percentage of equity interests acquired				100.00%
Number of contingent milestone payments | Milestone	4	4
Genentech agreement [member]
Disclosure of contingent liabilities [line items]
Number of contingent milestone payments | Milestone	1	1
Milestone Two [member]
Disclosure of contingent liabilities [line items]
Contingent consideration | $	$ 1,250,000

XML

Deferred tax - Summary of non-current liabilities - deferred tax (Detail) - AUD ($) $ in Thousands	Jun. 30, 2021	Jun. 30, 2020
Deferred tax assets and liabilities [abstract]
Deferred tax liability associated with Licensing Agreement - Non-current liabilities	$ 2,928	$ 3,413

XML

Equity - contributed equity - Summary of movements in ordinary share capital (Detail)													12 Months Ended
	Jun. 30, 2021 AUD ($) $ / shares shares	Jun. 30, 2021 $ / shares	May 21, 2021 $ / shares	Apr. 28, 2021 $ / shares	Mar. 15, 2021 $ / shares	Mar. 02, 2021 $ / shares	Oct. 26, 2020 $ / shares	Oct. 12, 2020 $ / shares	Aug. 28, 2020 $ / shares	May 11, 2020 $ / shares	Apr. 16, 2020 $ / shares	Nov. 01, 2019 $ / shares	Jun. 30, 2021 AUD ($) shares	Jun. 30, 2020 AUD ($) shares	Jun. 30, 2019 AUD ($) shares
Disclosure of classes of share capital [line items]
Beginning Balance													$ 14,125,000	$ 14,195,000	$ 19,242,000
Issue of shares													273,000	12,972,000	5,406,000
Ending balance	$ 37,851,000												$ 37,851,000	$ 14,125,000	$ 14,195,000
Contributed equity [member]
Disclosure of classes of share capital [line items]
Beginning Balance | shares													94,598,369	62,166,673
Ending Balance | shares	132,012,209												132,012,209	94,598,369	62,166,673
Beginning Balance													$ 48,781,214	$ 36,641,519	$ 31,576,000
Issue of shares													273,000	12,972,000	5,406,000
Ending balance	$ 80,290,062												$ 80,290,062	$ 48,781,214	$ 36,641,519
Share Placement [member]
Disclosure of classes of share capital [line items]
Issue price | $ / shares				$ 1.407							$ 0.400	$ 0.400
Share Placement [member] | Contributed equity [member] | 1 November 2019 [Member]
Disclosure of classes of share capital [line items]
Increase (decrease) in shares outstanding | shares														10,000,000
Issue of shares														$ 4,000,000
Share Placement [member] | Contributed equity [member] | 16 April 2020 [Member]
Disclosure of classes of share capital [line items]
Increase (decrease) in shares outstanding | shares														18,041,667
Issue of shares														$ 7,216,667
Share Placement [member] | Contributed equity [member] | 28 April 2021 {Member]
Disclosure of classes of share capital [line items]
Increase (decrease) in shares outstanding | shares													3,037,580
Issue of shares													$ 4,274,633
Share purchase plan [member]
Disclosure of classes of share capital [line items]
Issue price | $ / shares										$ 0.400
Share purchase plan [member] | Contributed equity [member]
Disclosure of classes of share capital [line items]
Increase (decrease) in shares outstanding | shares														4,390,010
Issue of shares														$ 1,756,004
Share issue transaction costs [member]
Disclosure of classes of share capital [line items]
Issue price | (per share)	$ 0.000	$ 0.000
Share issue transaction costs [member] | Contributed equity [member]
Disclosure of classes of share capital [line items]
Issue of shares													$ (1,673,388)	$ (833,052)
Conversion of options [member]
Disclosure of classes of share capital [line items]
Issue price | (per share)	$ 4.000				$ 0.493	$ 0.635			$ 0.493
Conversion of options [member] | Contributed equity [member]
Disclosure of classes of share capital [line items]
Increase (decrease) in shares outstanding | shares														19
Issue of shares														$ 76
Conversion of options [member] | Contributed equity [member] | 2 March 2021 [Member]
Disclosure of classes of share capital [line items]
Increase (decrease) in shares outstanding | shares													391,500
Issue of shares													$ 248,661
Conversion of options [member] | Contributed equity [member] | 15 March 2021 [Member]
Disclosure of classes of share capital [line items]
Increase (decrease) in shares outstanding | shares													25,000
Issue of shares													$ 12,313
Conversion of options [member] | Contributed equity [member] | 28 August 2020 [Member]
Disclosure of classes of share capital [line items]
Increase (decrease) in shares outstanding | shares													25,000
Issue of shares													$ 12,313
Institutional placement under ANREO [Member]
Disclosure of classes of share capital [line items]
Issue price | $ / shares								$ 0.800
Institutional placement under ANREO [Member] | Contributed equity [member]
Disclosure of classes of share capital [line items]
Increase (decrease) in shares outstanding | shares													20,525,820
Issue of shares													$ 16,420,656
Retail placement under ANREO [Member]
Disclosure of classes of share capital [line items]
Issue price | $ / shares							$ 0.800
Retail placement under ANREO [Member] | Contributed equity [member]
Disclosure of classes of share capital [line items]
Increase (decrease) in shares outstanding | shares													11,017,075
Issue of shares													$ 8,813,660
Issued on achievement of a milestone [Member]
Disclosure of classes of share capital [line items]
Issue price | $ / shares			$ 1.421
Issued on achievement of a milestone [Member] | Contributed equity [member]
Disclosure of classes of share capital [line items]
Increase (decrease) in shares outstanding | shares													2,391,865
Issue of shares													$ 3,400,000

XML

Equity - contributed equity - Summary of equity - contributed equity (Detail) - AUD ($)	Jun. 30, 2021	Jun. 30, 2020	Sep. 14, 2016
Disclosure of classes of share capital [abstract]
Ordinary shares - fully paid, shares	132,012,209	94,598,369	20,000,000
Ordinary shares - fully paid	$ 80,290,062	$ 48,781,214

XML

Equity - contributed equity - Additional Information (Detail)	Jun. 30, 2021 $ / shares
Disclosure of classes of share capital [abstract]
Fully paid ordinary shares par value	$ 0

XML

Equity - Other contributed equity - Summary of equity -Other contributed equity (Detail) - AUD ($)	Jun. 30, 2021	Jun. 30, 2020
Statement of changes in equity [abstract]
Convertible note - Triaxial	$ 464,000	$ 464,000

XML

Equity - Other contributed equity - Additional Information (Detail) - shares	12 Months Ended
	Jun. 30, 2021	Jun. 30, 2017	Jun. 30, 2020	Oct. 31, 2016	Sep. 14, 2016
Statement of changes in equity [abstract]
Number of ordinary shares issued	132,012,209		94,598,369		20,000,000
Number of ordinary shares available for conversion	1,865,000			16,000,000
Percentage of capital acquired by third party for early conversion of convertibles notes		50.00%
Number of convertible note may be converted into ordinary shares	1,856,000

XML

Financial instruments - Summary of foreign currency risk (Detail) - Foreign currency risk [member] - AUD ($) $ in Thousands	Jun. 30, 2021	Jun. 30, 2020
Disclosure of detailed information about financial instruments [line items]
Assets	$ 21,073	$ 272
Liabilities	3,464	2,196
US dollars [member]
Disclosure of detailed information about financial instruments [line items]
Assets	21,073	272
Liabilities	3,448	2,196
Euros [member]
Disclosure of detailed information about financial instruments [line items]
Liabilities	$ 16	$ 0

XML

Financial instruments - Additional Information (Detail) - AUD ($)	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2019	Jun. 30, 2018
Disclosure of detailed information about financial instruments [line items]
Net assets denominated in foreign currencies	$ 58,088,000	$ 23,063,000
Net Liabilities denominated in foreign currencies	20,237,000	8,938,000
Cash and cash equivalents	27,586,760	8,764,044	$ 5,434,000	$ 5,956,000
Foreign currency risk [member]
Disclosure of detailed information about financial instruments [line items]
Net assets denominated in foreign currencies	$ 17,608,845
Net Liabilities denominated in foreign currencies		$ 1,923,831
Foreign currency risk [member] | US dollars [member]
Disclosure of detailed information about financial instruments [line items]
Hypothetical percentage change in risk	10.00%	10.00%
Interest rate risk [member]
Disclosure of detailed information about financial instruments [line items]
Hypothetical percentage change in risk	100.00%	100.00%
Favourable/adverse effect on profit before tax and equity	$ 275,867	$ 87,640

XML

Financial instruments - Summary of foreign currency risk sensitivity (Detail) - Foreign currency risk [member] - AUD ($) $ in Thousands	Jun. 30, 2021	Jun. 30, 2020
US dollars [member]
Disclosure of detailed information about financial instruments [line items]
% change	10.00%	10.00%
Increase in market risk [member] | US dollars [member]
Disclosure of detailed information about financial instruments [line items]
% change	10.00%	10.00%
Increase in market risk [member] | Euros [member]
Disclosure of detailed information about financial instruments [line items]
% change	10.00%
Effect of increase in market risk on profit (loss) before tax [member]
Disclosure of detailed information about financial instruments [line items]
Effect on profit before tax/equity	$ (1,761)
Effect of increase in market risk on profit (loss) before tax [member] | US dollars [member]
Disclosure of detailed information about financial instruments [line items]
Effect on profit before tax/equity	(1,762)	$ 192
Effect of increase in market risk on profit (loss) before tax [member] | Euros [member]
Disclosure of detailed information about financial instruments [line items]
Effect on profit before tax/equity	1
Effect of increase in market risk on equity [member]
Disclosure of detailed information about financial instruments [line items]
Effect on profit before tax/equity	(1,761)
Effect of increase in market risk on equity [member] | US dollars [member]
Disclosure of detailed information about financial instruments [line items]
Effect on profit before tax/equity	(1,762)	$ 192
Effect of increase in market risk on equity [member] | Euros [member]
Disclosure of detailed information about financial instruments [line items]
Effect on profit before tax/equity	$ 1
Decrease in market risk [member] | US dollars [member]
Disclosure of detailed information about financial instruments [line items]
% change	(10.00%)	(10.00%)
Decrease in market risk [member] | Euros [member]
Disclosure of detailed information about financial instruments [line items]
% change	(10.00%)
Effect of decrease in market risk on profit (loss) before tax [member]
Disclosure of detailed information about financial instruments [line items]
Effect on profit before tax/equity	$ 1,761
Effect of decrease in market risk on profit (loss) before tax [member] | US dollars [member]
Disclosure of detailed information about financial instruments [line items]
Effect on profit before tax/equity	1,762	$ (192)
Effect of decrease in market risk on profit (loss) before tax [member] | Euros [member]
Disclosure of detailed information about financial instruments [line items]
Effect on profit before tax/equity	(1)
Effect of decrease in market risk on equity [member]
Disclosure of detailed information about financial instruments [line items]
Effect on profit before tax/equity	1,761
Effect of decrease in market risk on equity [member] | US dollars [member]
Disclosure of detailed information about financial instruments [line items]
Effect on profit before tax/equity	1,762	$ (192)
Effect of decrease in market risk on equity [member] | Euros [member]
Disclosure of detailed information about financial instruments [line items]
Effect on profit before tax/equity	$ (1)

XML

Financial instruments - Summary of variable interest rate balances (Detail) - AUD ($) $ in Thousands	12 Months Ended
	Jun. 30, 2021	Jun. 30, 2020
Disclosure of financial instruments by type of interest rate [line items]
Cash at bank and in hand	$ 21,087	$ 1,264
Short term deposits	6,500	7,500
Interest rate risk [member] | Variable interest rate [member]
Disclosure of financial instruments by type of interest rate [line items]
Cash at bank and in hand	21,087	1,264
Short term deposits	6,500	7,500
Net exposure to cash flow interest rate risk	$ 27,587	$ 8,764
Interest rate risk [member] | Variable interest rate [member] | Weighted average [member] | Cash at bank and in hand [member]
Disclosure of financial instruments by type of interest rate [line items]
Interest rate	0.00%	0.04%
Interest rate risk [member] | Variable interest rate [member] | Weighted average [member] | Short term deposits [member]
Disclosure of financial instruments by type of interest rate [line items]
Interest rate	0.04%	0.95%

XML

Financial instruments - Summary of remaining contractual maturities of financial instrument liabilities (Detail) - AUD ($) $ in Thousands	Jun. 30, 2021	Jun. 30, 2020
Disclosure of maturity analysis for non-derivative financial liabilities [line items]
Trade payables	$ 1,893	$ 1,694
Accrued payables	3,039	1,795
Contingent consideration	12,471	4,199
Total non-derivatives	17,403	7,688
1 year or less [member]
Disclosure of maturity analysis for non-derivative financial liabilities [line items]
Trade payables	1,893	1,694
Accrued payables	3,039	1,795
Contingent consideration	3,165
Total non-derivatives	8,097	3,489
Between 1 and 2 years [member]
Disclosure of maturity analysis for non-derivative financial liabilities [line items]
Contingent consideration		4,199
Total non-derivatives		$ 4,199
Between 2 and 5 years [member]
Disclosure of maturity analysis for non-derivative financial liabilities [line items]
Contingent consideration	9,306
Total non-derivatives	$ 9,306

XML

Fair value measurement - Summary of assets and liabilities, measured or disclosed at fair value (Detail) - AUD ($) $ in Thousands	Jun. 30, 2021	Jun. 30, 2020
Disclosure of fair value measurement of assets [line items]
Contingent Consideration	$ 8,927	$ 458
Total liabilities	20,237	8,938
At fair value [member]
Disclosure of fair value measurement of assets [line items]
Contingent Consideration	1,015	1,845
Total liabilities	1,015	1,845
At fair value [member] | Level 3 [member]
Disclosure of fair value measurement of assets [line items]
Contingent Consideration	1,015	1,845
Total liabilities	$ 1,015	$ 1,845

XML

Fair value measurement - Summary of movements in level 3 assets and liabilities (Detail) - At fair value [member] - AUD ($) $ in Thousands	12 Months Ended
	Jun. 30, 2021	Jun. 30, 2020
Disclosure of detailed information about movements in level 3 assets and liabilities [Line Items]
Balance Beginning	$ 1,845	$ 1,370
Losses recognised in profit or loss	2,570	475
Payout of milestone	(3,400)
Balance Ending	1,015	1,845
Available for sale [member]
Disclosure of detailed information about movements in level 3 assets and liabilities [Line Items]
Losses recognised in profit or loss		0
Balance Ending	0
Level 3 [member]
Disclosure of detailed information about movements in level 3 assets and liabilities [Line Items]
Balance Beginning	1,845	1,370
Losses recognised in profit or loss	2,570	475
Payout of milestone	(3,400)
Balance Ending	$ 1,015	$ 1,845

XML

Fair value measurement - Additional Information (Detail)	12 Months Ended
	Jun. 30, 2021	Jun. 30, 2020
Disclosure of fair value measurement of assets [line items]
Milestone payment discount rate	15.00%	35.00%
Bottom of range [member]
Disclosure of fair value measurement of assets [line items]
Milestone payment discount rate	35.00%
Top of range [member]
Disclosure of fair value measurement of assets [line items]
Milestone payment discount rate	55.00%

XML

Key management personnel disclosures - Summary of compensation made to directors and other members of key management personnel (Detail) - AUD ($) $ in Thousands	12 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2019
Related party transactions [abstract]
Short-term employee benefits	$ 1,574	$ 1,324	$ 1,176
Post-employment benefits	112	97	84
Share-based payments	617	230	125
Key management personnel compensation	$ 2,303	$ 1,651	$ 1,385

XML

Remuneration of auditors - Summary of remuneration of auditors (Detail) - AUD ($) $ in Thousands	12 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2019
Auditor's remuneration [abstract]
Audit or review of the financial statements	$ 151	$ 124	$ 120
Auditors remuneration	$ 151	$ 124	$ 120

XML

Related party transactions - Additional Information (Detail)	Jun. 30, 2021 AUD ($)
Disclosure of transactions between related parties [line items]
Trade receivables from related parties	$ 0
Trade payables to related parties	0
Loan to related parties	0
Loan from related parties	$ 0

XML

Parent entity information - Statement of profit or loss and other comprehensive income (Detail) - AUD ($)	12 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2019
Disclosure of parent entity information [line items]
Loss after income tax	$ (8,421,960)	$ (12,467,466)	$ (10,270,000)
Total comprehensive income	(8,420,000)	(12,471,000)	$ (10,359,000)
Parent [member]
Disclosure of parent entity information [line items]
Loss after income tax	(16,854,000)	(11,064,000)
Total comprehensive income	$ (16,854,000)	$ (11,064,000)

XML

Parent entity information - Statement of financial position (Detail) - AUD ($)	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2019	Jun. 30, 2018
Disclosure of parent entity information [line items]
Total current assets	$ 29,391,000	$ 10,653,000
Total assets	58,088,000	23,063,000
Total current liabilities	8,327,000	5,067,000
Total liabilities	20,237,000	8,938,000
Equity
Contributed equity	80,290,062	48,781,214
Other contributed equity	464,000	464,000
Reserves	1,301,000	1,066,000
Accumulated losses	(44,204,000)	(36,186,000)
Total equity	37,851,000	14,125,000	$ 14,195,000	$ 19,242,000
Parent [member]
Disclosure of parent entity information [line items]
Total current assets	25,042,000	9,703,000
Total assets	47,044,000	22,113,000
Total current liabilities	3,177,000	1,522,000
Total liabilities	15,032,000	5,393,000
Equity
Contributed equity	80,290,000	48,781,000
Other contributed equity	464,000	464,000
Reserves	1,754,000	1,521,000
Accumulated losses	(50,496,000)	(34,046,000)
Total equity	$ 32,012,000	$ 16,720,000

XML

Interests in subsidiaries - Summary of interest in subsidiaries (Detail)	12 Months Ended
	Jun. 30, 2021	Jun. 30, 2020
Kazia Laboratories Pty Ltd [member]
Disclosure of subsidiaries [line items]
Principal place of business	Australia
Country of incorporation	Australia
Ownership interest	100.00%	100.00%
Kazia Research Pty Ltd [member]
Disclosure of subsidiaries [line items]
Principal place of business	Australia
Country of incorporation	Australia
Ownership interest	100.00%	100.00%
Kazia Therapeutics Inc [member]
Disclosure of subsidiaries [line items]
Principal place of business	United States of America
Country of incorporation	United States of America
Ownership interest	100.00%	100.00%
Glioblast Pty Ltd [member]
Disclosure of subsidiaries [line items]
Principal place of business	Australia
Country of incorporation	Australia
Ownership interest	100.00%	100.00%
Kazia Therapeutics (Hong Kong) Limited [Member]
Disclosure of subsidiaries [line items]
Principal place of business	Hong Kong
Country of incorporation	Hong Kong
Ownership interest	100.00%

XML

Reconciliation of loss after income tax to net cash used in operating activities - Disclosure of reconciliation of profit or loss to operating cash flows (Detail) - AUD ($)	12 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2019
Disclosure of reconciliation of profit or loss to operating cash flows [Line Items]
Loss after income tax expense from continuing operations	$ (8,421,960)	$ (12,467,466)	$ (10,270,000)
Adjustments for:
Depreciation & amortisation	1,265,000	1,084,000	1,084,000
Impairment of property, plant & equipment			1,000
Net fair value loss on financial assets		168,000	1,809,000
Share based payments	637,000	262,000	246,000
Foreign exchange differences	430,000
Loss on contingent consideration	2,570,000	474,000	63,000
Change in operating assets & liabilities:	(3,521,000)	(10,479,000)	(7,067,000)
Decrease in trade and other receivables	(5,027,000)	358,000	825,000
Increase/(decrease) in accrued revenue			(138,000)
Decrease/(increase) in prepayments	(1,182,000)	(168,000)	398,000
Decrease/(increase) in trade and other payables	1,010,000	1,722,000	(409,000)
Decrease in deferred tax liability	(484,000)	(298,000)	(298,000)
Increase/(decrease) in other provisions	93,000	55,000	(25,000)
Net cash used in operating activities	$ (9,111,000)	$ (8,810,000)	$ (6,714,000)

XML

Earnings per share - Summary of earnings per share (Detail) - AUD ($)	12 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2019
Earnings per share [abstract]
Loss after income tax attributable to the owners of Kazia Therapeutics Limited	$ (8,421,960)	$ (12,467,466)	$ (10,270,000)
Loss after income tax attributable to the owners of Kazia Therapeutics Limited	$ (8,422,000)	$ (12,467,000)	$ (10,270,000)
Weighted average number of ordinary shares used in calculating basic earnings per share	117,674,543	73,053,514	57,503,555
Weighted average number of ordinary shares used in calculating diluted earnings per share	117,674,543	73,053,514	57,503,555
Basic earnings per share	$ (7.16)	$ (17.07)	$ (17.86)
Diluted earnings per share	$ (7.16)	$ (17.07)	$ (17.86)

XML

Earnings per share - Additional Information (Detail) - AUD ($)	12 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Oct. 31, 2016
Earnings per share [line items]
Number of unlisted convertible notes	1,865,000		16,000,000
Face value of convertible notes	$ 464,000	$ 464,000
Unlisted options [member]
Earnings per share [line items]
Number of options that have been excluded from the calculations as they were antidilutive	4,446,500

XML

Share-based payments - Additional Information (Detail)	12 Months Ended
	Jun. 30, 2021 shares	Jun. 30, 2021 AUD ($) shares	Jun. 30, 2021 shares	Jun. 30, 2021 shares	Jun. 30, 2020 shares
Disclosure of terms and conditions of share-based payment arrangement [line items]
Employee remuneration expense | $		$ 636,383
Weighted average remaining contractual life of outstanding share options	2 years 7 months 6 days				2 years 9 months 10 days
Number of options issued to employees			2,200,000	2,200,000	250,000
Tranche 9 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Number of Options vested				1,000,000
Number of options issued	1,200,000	1,200,000	1,200,000	1,200,000
Other Tranche One [Member] | Bottom of range [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Number of Options vested					9
Other Tranche One [Member] | Top of range [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Percentage of Options vested					75.00%
Other Tranche Two [Member] | Bottom of range [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Number of Options vested					12
Other Tranche Two [Member] | Top of range [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Percentage of Options vested					50.00%
Other Tranche Three [Member] | Bottom of range [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Number of Options vested					14
Other Tranche Three [Member] | Top of range [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Percentage of Options vested					50.00%
Other Tranche Four [Member] | Bottom of range [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Number of Options vested					15
Other Tranche Four [Member] | Top of range [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Percentage of Options vested					67.00%
Tranches 2 and 8 [Member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Percentage of Options vested			53.00%
Tranches 10 and 12 [Member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Percentage of Options vested			25.00%

XML

Share-based payments - Summary of share-based payments (Detail)	12 Months Ended
	Jun. 30, 2021	Jun. 30, 2021 $ / shares	Jun. 30, 2021	Jun. 30, 2021 AUD ($)	Jun. 30, 2021 shares	Jun. 30, 2020 AUD ($) $ / shares
Disclosure of terms and conditions of share-based payment arrangement [line items]
Balance at the start of the year, share options			2,775,167			2,660,766
Granted, share options			2,200,000		2,200,000	250,000
Exercised and modified			(441,500)			450,000
Expired /lapsed on termination of employment			(314,667)			(585,599)
Balance at the end of the year, share options			4,219,000			2,775,167
Balance at the start of the year, Weighted average exercise price		$ 0.797				$ 1.960
Granted, Weighted average exercise price		1.090				$ 0.880
Modified, Weighted average exercise price | $				$ 0.620		$ 2.348
Expired, Weighted average exercise price		1.850				$ 3.716
Balance at the end of the year, Weighted average exercise price		0.826				$ 0.797
Tranche 1 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date						04/03/2015
Expiry date						Dec. 16, 2019
Exercise price						$ 1.500
Balance at the start of the year, share options						46,647
Expired /lapsed on termination of employment						(46,647)
Tranche 2 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date						04/03/2015
Expiry date						Dec. 18, 2019
Exercise price						$ 1.500
Balance at the start of the year, share options						19,952
Expired /lapsed on termination of employment						(19,952)
Tranche 3 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date						24/06/2015
Expiry date						Jun. 30, 2020
Exercise price						$ 4.000
Balance at the start of the year, share options						519,000
Expired /lapsed on termination of employment						(519,000)
Tranche 4 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	16/11/2015					16/11/2015
Expiry date	Nov. 16, 2020					Nov. 16, 2020
Exercise price		2.200				$ 2.200
Balance at the start of the year, share options			236,667			236,667
Expired /lapsed on termination of employment			(236,667)
Balance at the end of the year, share options						236,667
Tranche 5 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date						18/03/2016
Expiry date						Feb. 01, 2021
Exercise price						$ 1.990
Balance at the start of the year, share options						300,000
Exercised and modified						(300,000)
Tranche 6 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date						18/03/2016
Expiry date						Feb. 01, 2021
Exercise price						$ 1.990
Balance at the start of the year, share options						200,000
Exercised and modified						(200,000)
Tranche 7 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date						18/03/2016
Expiry date						Feb. 01, 2021
Exercise price						$ 2.610
Balance at the start of the year, share options						250,000
Exercised and modified						(250,000)
Tranche 8 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	05/09/2016					05/09/2016
Expiry date	Sep. 05, 2021					Sep. 05, 2021
Exercise price		1.630				$ 1.630
Balance at the start of the year, share options			50,000			50,000
Balance at the end of the year, share options						50,000
Tranche 9 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	12/10/2016					12/10/2016
Expiry date	Oct. 17, 2021					Oct. 17, 2021
Exercise price		1.560				$ 1.560
Balance at the start of the year, share options			62,000			62,000
Balance at the end of the year, share options						62,000
Tranche 10 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	31/10/2016					31/10/2016
Expiry date	Nov. 01, 2021					Nov. 01, 2021
Exercise price		1.380				$ 1.380
Balance at the start of the year, share options			12,500			12,500
Balance at the end of the year, share options			12,500			12,500
Tranche 11 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	21/11/2016					21/11/2016
Expiry date	Nov. 23, 2021					Nov. 23, 2021
Exercise price		1.380				$ 1.380
Balance at the start of the year, share options			50,000			50,000
Balance at the end of the year, share options						50,000
Tranche 12 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	07/08/2017					07/08/2017
Expiry date	Aug. 07, 2022					Aug. 07, 2022
Exercise price		0.670				$ 0.670
Balance at the start of the year, share options			224,000			224,000
Exercised and modified			(121,500)
Expired /lapsed on termination of employment			(15,500)
Balance at the end of the year, share options			87,000			224,000
Tranche 13 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	05/02/2018					05/02/2018
Expiry date	Feb. 05, 2023					Feb. 05, 2023
Exercise price		0.780				$ 0.780
Balance at the start of the year, share options			440,000			440,000
Exercised and modified			(120,000)
Balance at the end of the year, share options			320,000			440,000
Tranche 14 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	04/01/2019					04/01/2019
Expiry date	Jan. 04, 2024					Jan. 04, 2024
Exercise price		0.492				$ 0.492
Balance at the start of the year, share options			250,000			250,000
Exercised and modified			(200,000)
Expired /lapsed on termination of employment			(12,500)
Balance at the end of the year, share options			37,500			250,000
Tranche 15 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	13/11/2019					13/11/2019
Expiry date	Jan. 04, 2024					Jan. 04, 2024
Exercise price		0.492				$ 0.492
Balance at the start of the year, share options			1,200,000
Exercised and modified						1,200,000
Balance at the end of the year, share options			1,200,000			1,200,000
Tranche 16 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	13/01/2020					13/01/2020
Expiry date	Jan. 13, 2025					Jan. 13, 2025
Exercise price		0.881				$ 0.881
Balance at the start of the year, share options			250,000
Granted, share options						250,000
Expired /lapsed on termination of employment			(50,000)
Balance at the end of the year, share options			200,000			250,000
Tranche 17 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	09/11/2020
Expiry date	Jan. 13, 2025
Exercise price		1.132
Granted, share options			1,200,000
Balance at the end of the year, share options			1,200,000
Tranche 18 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	09/11/2020
Expiry date	Jan. 13, 2025
Exercise price		0.881
Granted, share options			800,000
Balance at the end of the year, share options			800,000
Tranche 19 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	04/01/2021
Expiry date	Jan. 04, 2025
Exercise price		$ 1.690
Granted, share options			200,000
Balance at the end of the year, share options			200,000

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Share-based payments - Summary of valuation for each tranche of options (Detail)	12 Months Ended
	Jun. 30, 2021 USD ($) yr $ / shares	Jun. 30, 2020 $ / shares
Tranche 8 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	05/09/2016	05/09/2016
Expiry date	Sep. 05, 2021	Sep. 05, 2021
Share price at Grant Date	$ 0.105
Exercise price	$ 1.630	$ 1.630
Volatility (%)	122.00%
Remaining Option Life | yr	1.16
Risk free Rate	1.60%
Fair value per option | $	$ 0.840
Tranche 9 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	12/10/2016	12/10/2016
Expiry date	Oct. 17, 2021	Oct. 17, 2021
Share price at Grant Date	$ 0.098
Exercise price	$ 1.560	$ 1.560
Volatility (%)	122.00%
Remaining Option Life | yr	1.29
Risk free Rate	1.89%
Fair value per option | $	$ 0.780
Tranche 10 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	31/10/2016	31/10/2016
Expiry date	Nov. 01, 2021	Nov. 01, 2021
Share price at Grant Date	$ 0.090
Exercise price	$ 1.380	$ 1.380
Volatility (%)	122.00%
Remaining Option Life | yr	1.20
Risk free Rate	1.87%
Fair value per option | $	$ 0.720
Tranche 11 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	21/11/2016	21/11/2016
Expiry date	Nov. 23, 2021	Nov. 23, 2021
Share price at Grant Date	$ 0.092
Exercise price	$ 1.380	$ 1.380
Volatility (%)	122.00%
Remaining Option Life | yr	1.20
Risk free Rate	2.10%
Fair value per option | $	$ 0.730
Tranche 12 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	07/08/2017	07/08/2017
Expiry date	Aug. 07, 2022	Aug. 07, 2022
Share price at Grant Date	$ 0.430
Exercise price	$ 0.670	$ 0.670
Volatility (%)	74.50%
Remaining Option Life | yr	2.08
Risk free Rate	1.95%
Fair value per option | $	$ 0.206
Tranche 13 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	05/02/2018	05/02/2018
Expiry date	Feb. 05, 2023	Feb. 05, 2023
Share price at Grant Date	$ 0.500
Exercise price	$ 0.780	$ 0.780
Volatility (%)	74.50%
Remaining Option Life | yr	2.58
Risk free Rate	1.95%
Fair value per option | $	$ 0.200
Tranche 14 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	04/01/2019	04/01/2019
Expiry date	Jan. 04, 2024	Jan. 04, 2024
Share price at Grant Date	$ 0.340
Exercise price	$ 0.492	$ 0.492
Volatility (%)	74.50%
Remaining Option Life | yr	3.50
Risk free Rate	1.95%
Fair value per option | $	$ 0.140
Tranche 15 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	13/11/2019	13/11/2019
Expiry date	Jan. 04, 2024	Jan. 04, 2024
Share price at Grant Date	$ 0.410
Exercise price	$ 0.492	$ 0.492
Volatility (%)	74.50%
Remaining Option Life | yr	4.20
Risk free Rate	1.95%
Fair value per option | $	$ 0.180
Tranche 16 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	13/01/2020	13/01/2020
Expiry date	Jan. 13, 2025	Jan. 13, 2025
Share price at Grant Date	$ 0.620
Exercise price	$ 0.881	$ 0.881
Volatility (%)	74.50%
Remaining Option Life | yr	4.50
Risk free Rate	1.95%
Fair value per option | $	$ 0.340
Tranche 20 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	09/11/2020
Expiry date	Nov. 09, 2024
Share price at Grant Date	$ 0.890
Exercise price	$ 1.132
Volatility (%)	90.00%
Remaining Option Life | yr	2.10
Risk free Rate	0.10%
Fair value per option | $	$ 0.379
Tranche 21 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	09/11/2020
Expiry date	Nov. 09, 2024
Share price at Grant Date	$ 0.890
Exercise price	$ 1.132
Volatility (%)	90.00%
Remaining Option Life | yr	2.30
Risk free Rate	0.10%
Fair value per option | $	$ 0.403
Tranche 22 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	09/11/2020
Expiry date	Nov. 09, 2024
Share price at Grant Date	$ 0.890
Exercise price	$ 1.132
Volatility (%)	90.00%
Remaining Option Life | yr	2.60
Risk free Rate	0.10%
Fair value per option | $	$ 0.425
Tranche 23 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	09/11/2020
Expiry date	Nov. 09, 2024
Share price at Grant Date	$ 0.890
Exercise price	$ 1.132
Volatility (%)	90.00%
Remaining Option Life | yr	2.80
Risk free Rate	0.10%
Fair value per option | $	$ 0.446
Tranche 24 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	09/11/2020
Expiry date	Jan. 13, 2025
Share price at Grant Date	$ 0.890
Exercise price	$ 0.881
Volatility (%)	90.00%
Remaining Option Life | yr	2.20
Risk free Rate	0.10%
Fair value per option | $	$ 0.450
Tranche 25 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	09/11/2020
Expiry date	Jan. 13, 2025
Share price at Grant Date	$ 0.890
Exercise price	$ 0.881
Volatility (%)	90.00%
Remaining Option Life | yr	2.70
Risk free Rate	0.10%
Fair value per option | $	$ 0.490
Tranche 26 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	09/11/2020
Expiry date	Jan. 13, 2025
Share price at Grant Date	$ 0.890
Exercise price	$ 0.881
Volatility (%)	90.00%
Remaining Option Life | yr	3.20
Risk free Rate	0.10%
Fair value per option | $	$ 0.520
Tranche 27 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	09/11/2020
Expiry date	Jan. 13, 2025
Share price at Grant Date	$ 0.890
Exercise price	$ 0.881
Volatility (%)	90.00%
Remaining Option Life | yr	3.70
Risk free Rate	0.10%
Fair value per option | $	$ 0.550
Tranche 28 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	04/01/2021
Expiry date	Jan. 04, 2025
Share price at Grant Date	$ 1.185
Exercise price	$ 1.169
Volatility (%)	90.00%
Remaining Option Life | yr	2.50
Risk free Rate	0.19%
Fair value per option | $	$ 0.520
Tranche 29 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	04/01/2021
Expiry date	Jan. 04, 2025
Share price at Grant Date	$ 1.185
Exercise price	$ 1.169
Volatility (%)	90.00%
Remaining Option Life | yr	3.00
Risk free Rate	0.19%
Fair value per option | $	$ 0.576
Tranche 30 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	04/01/2021
Expiry date	Jan. 04, 2025
Share price at Grant Date	$ 1.185
Exercise price	$ 1.169
Volatility (%)	90.00%
Remaining Option Life | yr	3.50
Risk free Rate	0.19%
Fair value per option | $	$ 0.627
Tranche 31 [member]
Disclosure of terms and conditions of share-based payment arrangement [line items]
Grant date	04/01/2021
Expiry date	Jan. 04, 2025
Share price at Grant Date	$ 1.185
Exercise price	$ 1.169
Volatility (%)	90.00%
Remaining Option Life | yr	4.00
Risk free Rate	0.19%
Fair value per option | $	$ 0.671