UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM
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CURRENT REPORT
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Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, 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. ☐
On March 26, 2024, the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
In accordance with General Instruction B.2 of Form 8-K, the information in the press release attached as Exhibit 99.1 hereto shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
| Exhibit 99.1 | Press Release dated March 26, 2024 | |
| Exhibit 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Aptose Biosciences Inc. | ||
| Date: March 26, 2024 | By: | /s/ William G. Rice, Ph.D. |
| William G. Rice, Ph.D. | ||
| Chairman, President, and Chief Executive Officer | ||
EXHIBIT 99.1
Aptose Reports Results for the Fourth Quarter and Full Year 2023
SAN DIEGO and TORONTO, March 26, 2024 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose” or the “Company”) (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral targeted agents to treat hematologic malignancies, today announced financial results for the three months and year ended December 31, 2023, and provided a corporate update.
“The data we have generated from tuspetinib thus far – as a single agent and in combination therapy with venetoclax in relapsed and refractory AML – have demonstrated a distinctly favorable safety profile and broad activity for tuspetinib across mutational subtypes. This profile also extends to FLT3 wildtype AML, which represents the majority of AML patients, and in which few agents have shown such broad activity,” said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. “These data have propelled us to initiate a clinical study of tuspetinib in a triplet combination with venetoclax and azacitidine in frontline therapy for newly diagnosed AML, including both FLT3 wild type and FLT3 mutated subtypes.”
Key Corporate Highlights
Multiple Planned Value-creating Milestones Ahead
FINANCIAL RESULTS OF OPERATIONS
| Balance Sheet Data (unaudited) ($ in thousands) | ||||||||
| December 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| Cash, cash equivalents and short-term investments | $ | 9,252 | $ | 46,959 | ||||
| Working capital | (3,375 | ) | 37,235 | |||||
| Total assets | 12,989 | 51,027 | ||||||
| Non-current liabilities | 621 | 1,002 | ||||||
| Deficit | (515,537 | ) | (464,330 | ) | ||||
| Total shareholders’ equity | (2,901 | ) | 37,741 | |||||
| Statements of Operations Data (unaudited) | ||||||||
| Year ended December 31, | ||||||||
| (in thousands except per Common Share data) | 2023 | 2022 | ||||||
| Revenues | $ | - | $ | - | ||||
| R&D, related party | 3,492 | 3,556 | ||||||
| Research and development expenses | 33,273 | 24,532 | ||||||
| General and administrative expenses | 15,591 | 14,514 | ||||||
| Net finance income | 1,149 | 779 | ||||||
| Net loss | $ | (51,207 | ) | $ | (41,823 | ) | ||
| Basic and diluted loss per Common Share | $ | (7.58 | ) | $ | (6.80 | ) | ||
| Weighted average number of common shares outstanding used in the calculation of basic loss per share | 6,755 | 6,151 | ||||||
Net loss for the year ended December 31, 2023 increased by $9.4 million to $51.2 million, as compared to $41.8 million for the comparable period in 2022.
Research and Development Expenses
The research and development expenses for years ended December 31, 2023, and 2022 are as follows:
| Twelve months ended | |||||||
| December 31, | |||||||
| (in thousands) | 2023 | 2022 | |||||
| Program costs – Tuspetinib | $ | 24,925 | $ | 10,083 | |||
| Program costs – Luxeptinib | 3,510 | 8,426 | |||||
| Program costs – APTO-253 | 40 | 141 | |||||
| Personnel related expenses | 6,878 | 7,181 | |||||
| Stock-based compensation | 1,373 | 2,218 | |||||
| Depreciation of equipment | 39 | 39 | |||||
| Total | $ | 36,765 | $ | 28,088 | |||
R&D expenses increased by $8.7 million to $36.8 million for the year ended December 31, 2023, as compared with $28.1 million for the comparative period in 2022. Changes to the components of our R&D expenses presented in the table above are primarily related to the following activities:
General and Administrative Expenses
General and administrative expenses consist primarily of salaries, benefits, and travel, including stock-based compensation for our executive, finance, business development, human resources, and support functions. Other general and administrative expenses and professional fees include auditing, and legal services, investor relations and other consultants, insurance. and facility related expenses.
We expect that our general and administrative expenses will increase for the foreseeable future as we incur additional costs associated with being a publicly traded company and to support our pipeline of activities. We also expect our intellectual property related legal expenses to increase as our intellectual property portfolio expands.
The general and administrative expenses for the years ended December 31, 2023 and 2022 are as follows:
| Year ended December 31, | |||||||
| (in thousands) | 2023 | 2022 | |||||
| General and administrative, excluding items below: | $ | 13,262 | $ | 11,444 | |||
| Stock-based compensation | 2,280 | 2,989 | |||||
| Depreciation of equipment | 49 | 81 | |||||
| Total | $ | 15,591 | $ | 14,514 | |||
General and administrative expenses increased by approximately $1.1 million $15.6 million for the year ended December 31, 2023, as compared with $14.5 million for the comparative period in 2022. The increase was primarily as a result of higher salaries expenses, higher professional fees, and higher travel expenses, partly offset by a decrease in stock-based compensation costs.
Stock-based compensation decreased by $709 thousand mostly as a result of options having a lower grant date fair value as compared with the options granted in the comparative period.
| Conference Call & Webcast: | |
| Date: | Tuesday, March 26, 2024 |
| Time: | 5:00 PM ET |
| Audio Webcast Only: | link |
| Q&A Participant Registration Link*: | link |
| (https://register.vevent.com/register/BIe69f08fc83634a6aa38bf7081d82c6a2) | |
*Analysts interested in participating in the question-and-answer session will pre-register for the event from the participant registration link above to receive the dial-in numbers and a unique PIN, which are required to access the conference call. They also will have the option to take advantage of a Call Me button and the system will automatically dial out to connect to the Q&A session.
The audio webcast also can be accessed through a link on the Investor Relations section of Aptose’s website here. A replay of the webcast will be available on the company’s website for 30 days.
The press release, the financial statements and the management’s discussion and analysis for the year ended December 31, 2023 will be available on SEDAR at www.sedar.com and EDGAR at www.sec.gov/edgar.shtml.
About Aptose
Aptose Biosciences is a clinical-stage biotechnology company committed to developing precision medicines addressing unmet medical needs in oncology, with an initial focus on hematology. The Company's small molecule cancer therapeutics pipeline includes products designed to provide single agent efficacy and to enhance the efficacy of other anti-cancer therapies and regimens without overlapping toxicities. The Company has two clinical-stage oral kinase inhibitors under development for hematologic malignancies: tuspetinib (HM43239), an oral, myeloid kinase inhibitor being studied as monotherapy and in combination therapy in the APTIVATE international Phase 1/2 expansion trial in patients with relapsed or refractory acute myeloid leukemia (AML); and luxeptinib (CG-806), an oral, dual lymphoid and myeloid kinase inhibitor in Phase 1 a/b stage development for the treatment of patients with relapsed or refractory hematologic malignancies. For more information, please visit www.aptose.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Canadian and U.S. securities laws, including, but not limited to, statements regarding the Company’s clinical development plans, the clinical potential, anti-cancer activity, therapeutic potential and applications and safety profile of tuspetinib and luxeptinib, clinical trials, alternative development paths and collaborations to advance luxeptinib, upcoming milestones, expected increase of expenses and statements relating to the Company’s plans, objectives, expectations and intentions and other statements including words such as “continue”, “expect”, “intend”, “will”, “hope” “should”, “would”, “may”, “potential” and other similar expressions. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by us, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be materially different from any future results, performance or achievements described in this press release. Such factors could include, among others: our ability to obtain the capital required for research and operations; the inherent risks in early stage drug development including demonstrating efficacy; development time/cost and the regulatory approval process; the progress of our clinical trials; our ability to find and enter into agreements with potential partners; our ability to attract and retain key personnel; changing market and economic conditions; inability of new manufacturers to produce acceptable batches of GMP in sufficient quantities; unexpected manufacturing defects and other risks detailed from time-to-time in our ongoing current reports, quarterly filings, annual information forms, annual reports and annual filings with Canadian securities regulators and the United States Securities and Exchange Commission.
Should one or more of these risks or uncertainties materialize, or should the assumptions set out in the section entitled "Risk Factors" in our filings with Canadian securities regulators and the United States Securities and Exchange Commission underlying those forward-looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this press release and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by law. We cannot assure you that such statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Investors are cautioned that forward-looking statements are not guarantees of future performance and accordingly investors are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty therein.
For further information, please contact:
| Aptose Biosciences Inc. | LifeSci Advisors, LLC |
| Susan Pietropaolo | Dan Ferry, Managing Director |
| Corporate Communications & Investor Relations | 617-430-7576 |
| 201-923-2049 | Daniel@LifeSciAdvisors.com |
| spietropaolo@aptose.com |
Cover |
Mar. 26, 2024 |
|---|---|
| Cover [Abstract] | |
| Document Type | 8-K |
| Amendment Flag | false |
| Document Period End Date | Mar. 26, 2024 |
| Entity File Number | 001-32001 |
| Entity Registrant Name | Aptose Biosciences Inc. |
| Entity Central Index Key | 0000882361 |
| Entity Tax Identification Number | 98-1136802 |
| Entity Incorporation, State or Country Code | Z4 |
| Entity Address, Address Line One | 251 Consumers Road, Suite 1105 |
| Entity Address, City or Town | Toronto |
| Entity Address, State or Province | ON |
| Entity Address, Postal Zip Code | M2J 4R3 |
| City Area Code | 647 |
| Local Phone Number | 479-9828 |
| Written Communications | false |
| Soliciting Material | false |
| Pre-commencement Tender Offer | false |
| Pre-commencement Issuer Tender Offer | false |
| Title of 12(b) Security | Common Shares, no par value |
| Trading Symbol | APTO |
| Security Exchange Name | NASDAQ |
| Entity Emerging Growth Company | false |
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