UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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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. ☐
Item 1.01 Entry into a Material Definitive Agreement
On July 3, 2024 (the “Effective Date”), Kineta Inc. (“Kineta” or the “Company”) entered into an exclusivity and right of first offer agreement (the “Agreement”) by and between the Company and TuHURA Biosciences, Inc., a Delaware corporation (“TuHURA”). Capitalized terms used but not otherwise defined herein shall have the meaning ascribed to them in the Agreement.
Pursuant to the Agreement, among other things, Kineta has granted TuHURA an exclusive right to acquire Kineta’s worldwide patents, patent rights, patent applications, product and development program assets, technical and business information, and other rights and assets associated with and derived from its development program related to KVA12123, the Company’s VISTA blocking immunotherapy, during the period commencing as of the Effective Date and continuing through the first to occur of (a) the execution of any Definitive Agreement with respect to a Potential Transaction by TuHURA or one or more of its affiliates and (b) 11:59 PM Eastern Time on October 1, 2024, subject to extension as noted in the following sentence (the “Exclusivity Period”). In the event that the Parties are engaged in good faith discussions regarding a Potential Transaction on the date on which the Exclusivity Period (or any renewal thereof) is scheduled to expire and TuHURA has not yet closed the transactions contemplated by that previously announced agreement and plan of merger by and among TuHURA, Kintara Therapeutics, Inc. (“Kintara”) and Kayak Mergeco, Inc., a wholly-owned subsidiary of Kintara, then on such date, the Exclusivity Period shall automatically renew for an additional ten (10) day period (a “Renewal Period”) (up to a total of two (2) renewal periods for an aggregate of twenty (20) days).
In consideration for Kineta’s compliance with its obligations set forth in the Agreement, TuHURA will pay to Kineta $5,000,000 (the “Exclusivity Payment”), of which $2,500,000 was paid on the Effective Date and the remaining $2,500,000 will be paid on July 15, 2024. No later than two (2) business days after a Renewal Period has started (to be confirmed in writing by both Parties), TuHURA shall pay an additional $150,000 as an additional Exclusivity Payment, in an amount not to exceed $300,000 for the two (2) available Renewal Periods. The Exclusivity Payment will be credited against the initial cash consideration that may be payable to Kineta pursuant to any Definitive Agreement (if any) between Kineta and TuHURA and/or its affiliates with respect to a Potential Transaction.
The foregoing summary of the terms of the Agreement is subject to, and qualified in its entirety by reference to, the full text of the Agreement, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit
No. Document
99.1 Press release issued by Kineta, Inc., dated July 8, 2024
104 Cover Page Interactive Data File (embedded within the Inline XBRL document).
SIGNATURES
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.
Date: July 8, 2024
Kineta, Inc.
By: |
/s/ Craig Philips |
Name: |
Craig Philips |
Title: |
President |
Exhibit 10.1
EXCLUSIVITY AND RIGHT OF FIRST OFFER AGREEMENT
THIS EXCLUSIVITY AND RIGHT OF FIRST OFFER AGREEMENT (this “Agreement”) is made and dated as of July 3, 2024 (the “Effective Date”), by and between TuHURA Biosciences, Inc., a Delaware corporation (“TuHURA”), and Kineta, Inc., a Delaware corporation (“Kineta”). TuHURA and Kineta may be referred to herein individually as a “Party” and collectively as the “Parties”.
RECITALS
WHEREAS, Kineta is a clinical-stage biotechnology company that is engaged in a development program (the “Program”) relating to a product candidate referred to as KVA12123, which is an anti-VISTA antagonist (VISTA blocking) mAb immunotherapy to address tumor immunosuppression (the “Product”).
WHEREAS, TuHURA is a clinical stage immune-oncology company developing novel personalized cancer vaccine product candidates designed to overcome primary resistance to immunotherapies like checkpoint inhibitors, and TuHURA is considering a potential transaction (a “Potential Transaction”) involving the acquisition and/or licensure of the worldwide patents, patent rights, patent applications, product and development programs assets, technical and business information, and other rights and assets associated with and derived from the Product and Program (collectively, the “Program Assets”);
WHEREAS, TuHURA desires to conduct further due diligence on the Program, Product, and Program Assets in order to evaluate a Potential Transaction; and
WHERAS, in consideration of the Exclusivity Payment (as defined below) and the time, effort and expenses that TuHURA will expend investigating the Product, Program, and Program Assets and in connection with the negotiation, structuring, discussions, and preparation of definitive transaction documents, which the Parties expect would include the payment of additional consideration to Kineta by TuHURA, including, without limitation, cash, securities, pre- and post-regulatory milestone payments and royalties (the “Definitive Agreements”), related to the consummation of a Potential Transaction, Kineta desires to grant TuHURA exclusive access to all of Kineta’s information and personnel necessary to conduct its complete due diligence with respect to a Potential Transaction and to cooperate in all reasonable respects with TuHURA’s due diligence activities.
NOW, THEREFORE, in consideration of the foregoing and the respective representations, warranties, covenants and agreements set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:
AGREEMENT
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In the event that the Parties are engaged in good faith discussions regarding a Potential Transaction on the date on which the Exclusivity Period (or any renewal thereof) is scheduled to expire and TuHURA has not yet closed the transactions contemplated by that certain Agreement and Plan of Merger by and among TuHURA, Kintara Therapeutics, Inc. (“Kintara”) and Kayak Mergeco, Inc., a wholly-owned subsidiary of Kintara, then on such date the Exclusivity Period shall automatically renew for an additional ten (10) day period (a “Renewal Period”) (up to a total of two (2) Renewal Periods for an aggregate of twenty (20) days).
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If to Kineta:
7683 SE 27th Street, Suite 481
Mercer Island, WA 98040
Attention: Craig Philips
Email: cphilips@kineta.us
If to TuHURA:
10500 University Center Drive, Suite 110
Tampa, FL 3361
Attention: Dan Dearborn, Chief Financial Officer
Email: ddearborn@tuhurabio.com
Any Party hereto may change the address for receipt of communications by giving written notice to the other Party in accordance with this Section 9.
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[Signature page to follow]
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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the Effective Date.
TUHURA BIOSCIENCES, INC.
By: /s/ James D. Bianco
Name: James D. Bianco
Title: Chief Executive Officer
KINETA, INC.
By: /s/ Craig Philips
Name: Craig Philips
Title: President
EXHIBIT A
CLINICAL TRIAL ACTIONS
Exhibit 99.1
Kineta Announces Exclusivity and Right of First Offer Agreement for its VISTA blocking antibody with TuHURA Biosciences
TuHURA has an exclusive right to negotiate to acquire Kineta’s KVA12123 Immuno-Oncology Drug Program
Kineta will receive a $5 million Nonrefundable Payment from TuHURA
KVA12123 is currently in a Phase 1/Phase 2 Clinical Study in the United States
SEATTLE — (July 8, 2024) Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, announced today that it has entered into an exclusivity and right of first offer agreement (the “Agreement”) with TuHURA Biosciences, Inc. (“TuHURA”), a Phase 3 registration-stage immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy. Pursuant to the Agreement, among other things, Kineta has granted TuHURA an exclusive right to acquire Kineta’s worldwide patents, patent rights, patent applications, product and development program assets, technical and business information, and other rights and assets associated with and derived from its development program related to KVA12123, the Company’s VISTA blocking immunotherapy. This exclusive right shall continue through the first to occur of (a) the execution of any definitive agreement with respect to a potential transaction by TuHURA or one or more of its affiliates and (b) 11:59 PM Eastern Time on October 1, 2024, subject to extension. In consideration for Kineta’s compliance with its obligations set forth in the Agreement, TuHURA will pay Kineta a $5 million nonrefundable payment.
KVA12123 is a novel VISTA blocking monoclonal antibody being evaluated in a Phase 1/Phase 2 clinical trial for patients with advanced solid tumors. The study includes a monotherapy arm with KVA12123 alone, and a combination arm utilizing KVA12123 together with Merck’s anti-PD1 therapy, KEYTRUDA (pembrolizumab). Initial results from this study were reported in April this year at the American Association of Cancer Research. To date, the drug has been well tolerated with no dose limiting toxicities and no cytokine release syndrome. Additional data is expected to be released in the fourth quarter of 2024.
“TuHURA Biosciences is well positioned to advance KVA12123,” said Craig W. Philips, President of Kineta. “TuHURA is a Phase 3 registration stage immuno-oncology company with expertise and deep experience in the field. We believe they will make an excellent partner for this program and in advancing this novel drug program which could provide an important new treatment option for cancer patients.”
About Kineta
Kineta (Nasdaq: KA) is a clinical-stage biotechnology company with a mission to develop next-generation immunotherapies that transform patients’ lives. Kineta has leveraged its expertise in innate immunity and is focused on discovering and developing potentially differentiated immunotherapies that address the major challenges with current cancer therapy. The company’s immuno-oncology pipeline includes KVA12123, a novel VISTA blocking immunotherapy currently in a Phase 1/2 clinical trial in patients with advanced solid tumors, and a preclinical monoclonal antibody targeting CD27. For more information on Kineta, please visit www.kinetabio.com, and follow Kineta on X (formerly Twitter) and LinkedIn.
KVA12123, through the combination of unique epitope binding and an optimized IgG1 Fc region, has demonstrated strong tumor growth inhibition as both a monotherapy or in combination with other checkpoint inhibitors in preclinical models. KVA12123 provides a novel approach to address immune suppression in the TME with a mechanism of action that is differentiated and complementary with T cell focused therapies. KVA12123 may be an effective immunotherapy for many types of cancer including non-small cell lung (NSCLC), colorectal, renal cell carcinoma, head and neck, and ovarian cancer.
In February 2024, Kineta announced a significant corporate restructuring to substantially reduce expenses and preserve cash. The restructuring included a significant workforce reduction and the suspension of enrollment of new patients in its ongoing VISTA-101 Phase 1/2 clinical trial evaluating KVA12123 in patients with advanced solid tumors. Patients currently enrolled in the trial will be permitted to continue to participate. The Company announced the restructuring as a result of certain investors indicating that they would not fulfill their April 2024 funding obligation in the previously disclosed private placement financing. In connection with the restructuring, the Company announced that it is exploring strategic alternatives to maximize stockholder value.
Cautionary Statements Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The use of words such as, but not limited to, “believe,” “expect,” “estimate,” “project,” “intend,” “future,” “potential,” “continue,” “may,” “might,” “plan,” “will,” “should,” “seek,” “anticipate,” or “could” and other similar words or expressions are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements relating to the anticipated benefits of the Agreement and statements relating to Kineta’s exploration of strategic alternatives. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Kineta’s current beliefs, expectations and assumptions regarding the future of Kineta’s business, future plans and strategies, clinical results and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict
all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
Such forward-looking statements are subject to a number of material risks and uncertainties including, but not limited to: Kineta’s ability to successfully initiate and complete clinical trials; the difficulty in predicting the time and cost of development of Kineta’s product candidates; Kineta’s plans to research, develop and commercialize its current and future product candidates, including, but not limited to, KVA12123; the timing and anticipated results of Kineta’s planned pre-clinical studies and clinical trials and the risk that the results of Kineta’s pre-clinical studies and clinical trials may not be predictive of future results in connection with future studies or clinical trials; the timing of the availability of data from Kineta’s clinical trials; the timing of any planned investigational new drug application or new drug application; the risk of cessation or delay of any ongoing or planned clinical trials of Kineta or its collaborators; the clinical utility, potential benefits and market acceptance of Kineta’s product candidates; Kineta’s commercialization, marketing and manufacturing capabilities and strategy; developments and projections relating to Kineta’s competitors and its industry; the impact of government laws and regulations; the timing and outcome of Kineta’s planned interactions with regulatory authorities; Kineta’s ability to protect its intellectual property position; risks relating to volatility and uncertainty in the capital markets for biotechnology companies; availability of suitable third parties with which to conduct contemplated strategic transactions; whether Kineta will be able to pursue a strategic transaction, or whether any transaction, if pursued, will be completed on attractive terms or at all; whether Kineta’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital requirements; and those risks set forth under the caption “Risk Factors” in the Company’s most recent Annual Report on Form 10-K filed with the SEC on March 21, 2024, as well as discussions of potential risks, uncertainties and other important factors in Kineta’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Except as required by law, Kineta undertakes no obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Investor Relations:
info@kineta.us
Source: Kineta, Inc.
Document and Entity Information |
Jul. 03, 2024 |
---|---|
Cover [Abstract] | |
Entity Registrant Name | KINETA, INC./DE |
Amendment Flag | false |
Entity Central Index Key | 0001445283 |
Document Type | 8-K |
Document Period End Date | Jul. 03, 2024 |
Entity Incorporation State Country Code | DE |
Entity File Number | 001-37695 |
Entity Tax Identification Number | 20-8436652 |
Entity Address, Address Line One | 7683 SE 27th Street |
Entity Address, Address Line Two | Suite 481 |
Entity Address, City or Town | Mercer Island |
Entity Address, State or Province | WA |
Entity Address, Postal Zip Code | 98040 |
City Area Code | (206) |
Local Phone Number | 378-0400 |
Written Communications | false |
Soliciting Material | false |
Pre Commencement Tender Offer | false |
Pre Commencement Issuer Tender Offer | false |
Security 12b Title | Common Stock, par value $0.001 per share |
Trading Symbol | KA |
Security Exchange Name | NASDAQ |
Entity Emerging Growth Company | false |
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