Full Press Release Details
TuHURA Biosciences, Inc. Enters into Definitive Merger Agreement to Acquire
Opportunistic acquisition adds Phase 2 novel checkpoint inhibitor
(KVA12123) to TuHURA s late stage pipeline
Targeting Phase 2a/b trial with KVA12123 in mutated NPM1 AML in 2025
Cross product and technology synergies build on TuHURA s therapeutic focus
on overcoming primary and acquired resistance to cancer immunotherapy
Proposed Transaction expected to close in Q1 2025
TAMPA, FL and SEATTLE, WA, December 12, 2024 TuHURA Biosciences, Inc. (Nasdaq: HURA) ( TuHURA ), a Phase 3
registration-stage immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, and Kineta, Inc. (OTC Pink: KANT) ( Kineta ), a clinical-stage biotechnology company focused on the development of
novel immunotherapies in oncology that address cancer immune resistance, today announced that they have entered into a definitive merger agreement in which TuHURA would acquire Kineta, including the rights to Kineta s novel KVA12123 antibody,
for a combination of cash and shares of TuHURA common stock via a merger transaction (the Proposed Transaction ).
We are pleased to have
entered into this definitive agreement with Kineta, which represents the culmination of the Exclusivity and Right of First Offer Agreement that TuHURA and Kineta entered into in July 2024. Our strategy of providing Kineta this past summer with a
$5 million exclusivity fee to restart and finish their Phase 1 monotherapy and combination with pembrolizumab trial demonstrated our view that the PK/PD profile would position KVA12123 as a potential best-in-class V-domain Ig suppressor of T-cell activation (VISTA)-inhibiting antibody. We believe the real potential for this
class of checkpoint inhibitors resides in the treatment of blood related cancers. The data presented at the December 2024 ASH meeting indicates a strong correlation between NPM1 mutations (mNPM1) and elevated VISTA expression, particularly in the
context of acute myeloid leukemia (AML), where high VISTA levels on leukemia cells, associated with mNPM1, can potentially contribute to immune evasion and disease progression impacting their treatment response. Given mNPM1 drives leukemogenesis
through menin, and the introduction of menin inhibitors improving treatment responses in mNPM1-associated AML, a combination with a VISTA-inhibiting antibody could be the next step in improving response rates in AML, commented James Bianco,
M.D., President and Chief Executive Officer of TuHURA.
KVA12123 is a VISTA-blocking immunotherapy in development as a monoclonal antibody infusion drug dosed every
two-week cycles. It is completing two clinical trials both as a monotherapy and in combination with Merck s anti-PD1 therapy, KEYTRUDA (pembrolizumab), in patients with advanced treatment-refractory solid tumors. Competitive therapies targeting VISTA have demonstrated either poor monotherapy anti-tumor activity in preclinical
models or induction of cytokine release syndrome (CRS) in human clinical trials. Through the combination of unique epitope binding and an optimized IgG1 Fc region, KVA12123 demonstrates strong monotherapy tumor growth inhibition in preclinical
models without evidence of CRS in clinical trial participants. KVA12123 has been shown to de-risk the VISTA target and provides a novel approach to address immune suppression in the tumor microenvironment
(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 and represents the introduction of a new class of checkpoint inhibitors.
VISTA is a negative immune checkpoint that suppresses T cell function in a variety of solid tumors. High VISTA expression in tumor correlates with poor
survival in cancer patients and has been associated with a lack of response to other immune checkpoint inhibitors. Blocking VISTA induces an efficient polyfunctional immune response to address immunosuppression and drives anti-tumor responses.
KVA12123 has completed enrollment in its monotherapy arm, demonstrating safety at its highest dose level (1000mg). Kineta anticipates completion of enrollment
in the combination therapy arm where KVA12123 is administered with Merck s anti-PD1 therapy, KEYTRUDA (pembrolizumab). Initial results were
reported earlier this year at the American Association of Cancer Research (AACR) Annual Meeting 2024 and at the Society for Immunotherapy of Cancer (SITC) meeting, supporting best-in-class profile.
Following a thorough review of exploring strategic alternatives for Kineta and the
discussions held with TuHURA over the course of the past several months, we believe this acquisition by TuHURA maximizes shareholder value and provides an exciting development path forward for KVA12123. We believe KVA12123 has multiple synergies
with both of TuHURA s IFx and Delta receptor antibody-drug conjugate (ADC) and peptide drug conjugate (PDC) technologies and that a TuHURA acquisition will provide the necessary resources to advance KVA12123 through its clinical development,
maximizing value for Kineta s shareholders, said Craig W. Philips, President of Kineta. In addition to the TuHURA transaction, Kineta is continuing to pursue partnership opportunities for some of its other non-KVA12123-related products and technologies prior to the close of the TuHURA transaction.
Proposed Transaction
Under the terms of the merger agreement, upon the completion of the Proposed Transaction, Kineta stockholders will receive their
pro rata share (based on the number of Kineta fully diluted shares held by them) of aggregate merger consideration consisting of a combination of cash and shares of TuHURA common stock. The cash component of the aggregate merger consideration will
be a base cash amount of $9,005,000 (consisting of a value of $15,000,000 minus the $5,995,000 advanced to Kineta under the Exclusivity and Right of First Offer Agreement) less the sum of Kineta s working capital deficit at the closing of the
Proposed Transaction and any working
capital loans made by TuHURA to Kineta between the signing of the merger agreement and closing of the Proposed Transaction. The share component of the aggregate merger consideration will consist
of an aggregate of up to approximately 3,476,568 shares of TuHURA common stock, subject to a six-month holdback of approximately 869,142 of such shares to satisfy certain additional liabilities of the closing
date that may be identified after the closing. As additional merger consideration, Kineta stockholders will be entitled to receive their pro rata share of certain payments that Kineta may receive after the closing from the potential pre-closing sale by Kineta of certain non-KVA12123 products and technologies.
In connection with the merger agreement, TuHURA and Kineta entered into a Clinical Trial Funding Agreement under which TuHURA agreed to continue to fund
clinical trial expenses for KVA12123 in an amount of up to $900,000, which may be increased upon mutual agreement. The merger agreement also provides that Kineta may request the extension of up to $2,000,000 in working capital loans from TuHURA,
$1,750,000 of which will be contingent on the completion of a financing transaction by TuHURA.
The merger agreement has been unanimously approved by the
boards of directors of both companies and is subject to Kineta stockholder approval. The completion of the Proposed Transaction is also subject to the satisfaction or waiver of certain other conditions, such as the approval by TuHURA s
stockholders of an increase in the number of authorized shares of TuHURA common stock, Kineta s working capital deficit not exceeding $12,000,000 at the time of closing, the effectiveness of a registration statement on Form S-4 registering the shares of TuHURA common stock issuable to the Kineta stockholders in the Proposed Transaction, and other customary closing conditions. The Proposed Transaction is currently expected to close in
the first quarter of 2025.
About TuHURA Biosciences, Inc.
TuHURA Biosciences, Inc. (Nasdaq: HURA) is a Phase 3 registration-stage immuno-oncology company developing novel technologies to overcome primary and acquired
resistance to cancer immunotherapy, two of the most common reasons cancer immunotherapies fail to work or stop working in the majority of patients with cancer.
TuHURA s lead innate immune agonist candidate, IFx-2.0, is designed to overcome primary resistance to checkpoint
inhibitors. TuHURA is preparing to initiate a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda (pembrolizumab) in first line treatment for advanced or metastatic Merkel Cell Carcinoma.
In addition to its innate immune agonist candidates, TuHURA is leveraging its Delta receptor technology to
develop first-in-class bi-specific ADCs and PDCs targeting Myeloid Derived Suppressor Cells to inhibit their immune-suppressing
effects on the TME to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies.
For more information, please
visit tuhurabio.com and connect with TuHURA on Facebook, X, and LinkedIn.
Kineta, Inc. (OTC Pink: KANT) 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. Kineta 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
Through the combination of unique epitope binding and an optimized IgG1 Fc region, KVA12123 has demonstrated strong tumor
growth inhibition as both a monotherapy and 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 carcinoma (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. At that time, Kineta also announced that it was exploring strategic alternatives to maximize stockholder value.
Additional Information
About the Proposed Transaction for Investors and Shareholders
In connection with the Proposed Transaction between TuHURA and Kineta TuHURA and Kineta
intend to file with the U.S. Securities and Exchange Commission (the SEC ) a Registration Statement on Form S-4 that will contain a preliminary prospectus of TuHURA and a proxy statement of Kineta
in connection with the Proposed Transaction, referred to as a proxy statement/prospectus. If a proxy statement/prospectus is filed, after it is cleared by the SEC, a definitive proxy statement/prospectus will be mailed or made available to
Kineta s stockholders as of a record date to be established for voting on the Proposed Transaction and to the stockholders of TuHURA. TuHURA also will file other documents regarding the Proposed Transaction with the SEC. INVESTORS AND
STOCKHOLDERS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT/PROSPECTUS AND OTHER MATERIALS, IF ANY, THAT MAY BE FILED WITH THE SEC IN CONNECTION WITH THE PROPOSED TRANSACTION CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE
BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. THIS PRESS RELEASE IS NOT A SOLICITATION TO STOCKHOLDERS TO APPROVE ANY TRANSACTION.
Investors and stockholders will be able to obtain free copies of the proxy statement/prospectus and all
other relevant documents filed or that will be filed with the SEC by TuHURA through the website maintained by the SEC at www.sec.gov. The documents filed by TuHURA with the SEC may also be obtained free of charge at TuHURA s website at
www.tuhurabio.com or upon written request to: TuHURA, 10500 University Drive, Suite 110, Tampa, Florida 33612.
NEITHER THE SEC NOR ANY STATE SECURITIES
REGULATORY AGENCY HAS APPROVED OR DISAPPROVED THE PROPOSED TRANSACTION DESCRIBED IN THIS PRESS RELEASE, PASSED UPON THE MERITS OR FAIRNESS OF THE PROPOSED TRANSACTION OR RELATED TRANSACTIONS OR PASSED UPON THE ADEQUACY OR ACCURACY OF THE
DISCLOSURE IN THIS PRESS RELEASE. ANY REPRESENTATION TO THE CONTRARY CONSTITUTES A CRIMINAL OFFENSE.
TuHURA and Kineta and their respective directors and officers and other members of management may, under SEC rules, be deemed to
be participants in the solicitation of proxies from stockholders in connection with the Proposed Transaction and other matters that may be set forth in the proxy statement/prospectus. Information about TuHURA s directors and executive
officers is set forth in TuHURA s filings with the SEC, including TuHURA s Current Report on Form 8-K filed with the SEC on October 21, 2024. Information about Kineta s directors and
executive officers is set forth in Kineta s filings with the SEC, including Kineta s proxy statement filed with the SEC on April 26, 2024. Additional information regarding the direct and indirect interests, by security holdings or
otherwise, of those persons and other persons who may be deemed participants in the solicitation of proxies in the Proposed Transaction may be obtained by reading the proxy statement/prospectus when it becomes available. You may obtain free copies
of these documents as described above under Additional Information About the Proposed Transaction for Investors and Shareholders.
This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in
respect of the Proposed Transaction and is not intended to and does not constitute an offer to sell or the solicitation of an offer to buy the securities of TuHURA or Kineta, nor shall there be any sale of any such securities in any state or
jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting
the requirements of Section 10 of the Securities Act of 1933, as amended (the Securities Act ).
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of, and subject to the safe harbor created by, Section 27A
of the Securities Act, Section 21E of the Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, which are referred to as the safe harbor provisions. Statements included herein are not historical facts are
forward-looking statements, including statements about the beliefs and expectations of the management of each of TuHURA and Kineta. In some cases, you can identify these statements by terminology such as may, should,
plans, believe, will, anticipate, estimate, expect, project, or intend, including their opposites or similar phrases or expressions. TuHURA and Kineta
caution investors that any forward-looking statements, including statements related to anticipated operating results, business strategies and outlook of TuHURA and Kineta, proposed financing for the Proposed Transaction, anticipated benefits of the
Proposed Transaction, the anticipated impact of the Proposed Transaction on TuHURA s and Kineta s business and future financial and operating results, the expected amount and timing of synergies from the Proposed Transaction, the
anticipated closing date for the Proposed Transaction, and other aspects of Kineta s and TuHURA s operations or operating results, are only predictions and involve known and unknown risks and uncertainties, many of which are beyond
TuHURA s and Kineta s control, and could cause actual results to differ materially from those indicated in such forward-looking statements, which speak only as of the date of the press release. These factors, risks and uncertainties