TuHURA Biosciences, Inc. Enters into Definitive Merger Agreement to Acquire Kineta, Inc.
TuHURA Biosciences (NASDAQ:HURA) has entered into a definitive merger agreement to acquire Kineta, Inc. (OTC PINK:KANT), gaining rights to Kineta's novel KVA12123 antibody. The acquisition adds a Phase 2 novel checkpoint inhibitor to TuHURA's pipeline, with plans for a Phase 2a/b trial in mutated NPM1 AML in 2025.
KVA12123 is a VISTA-blocking immunotherapy administered as a monoclonal antibody infusion every two weeks. It has completed enrollment in its monotherapy arm, demonstrating safety at 1000mg dose level, and is finishing combination therapy trials with KEYTRUDA®. The transaction, following a $5 million exclusivity fee paid in July 2024, is expected to close in Q1 2025.
TuHURA Biosciences (NASDAQ:HURA) ha firmato un accordo di fusione definitivo per acquisire Kineta, Inc. (OTC PINK:KANT), acquisendo i diritti sull'innovativo anticorpo KVA12123 di Kineta. Questa acquisizione aggiunge un'inibitore checkpoint di fase 2 al pipeline di TuHURA, con piani per uno studio di fase 2a/b sulla leucemia mieloide acuta (AML) mutata NPM1 nel 2025.
KVA12123 è un'immunoterapia che blocca VISTA, somministrata come infusione di anticorpi monoclonali ogni due settimane. Ha completato l'arruolamento nel suo braccio di monoterapia, dimostrando sicurezza a un livello di dose di 1000 mg, e sta terminando gli studi sulla terapia combinata con KEYTRUDA®. La transazione, a seguito di un pagamento di esclusività di 5 milioni di dollari effettuato a luglio 2024, dovrebbe chiudersi nel primo trimestre del 2025.
TuHURA Biosciences (NASDAQ:HURA) ha firmado un acuerdo de fusión definitivo para adquirir Kineta, Inc. (OTC PINK:KANT), obteniendo los derechos sobre el novedoso anticuerpo KVA12123 de Kineta. La adquisición agrega un inhibidor de punto de control de fase 2 al pipeline de TuHURA, con planes para un ensayo de fase 2a/b en leucemia mieloide aguda (AML) mutada NPM1 en 2025.
KVA12123 es una inmunoterapia que bloquea VISTA, administrada como una infusión de anticuerpos monoclonales cada dos semanas. Ha completado la inscripción en su brazo de monoterapia, demostrando seguridad a un nivel de dosis de 1000 mg, y está finalizando ensayos de terapia combinada con KEYTRUDA®. Se espera que la transacción, tras un pago de exclusividad de 5 millones de dólares realizado en julio de 2024, se cierre en el primer trimestre de 2025.
TuHURA 바이오사이언스 (NASDAQ:HURA)는 Kineta, Inc. (OTC PINK:KANT)를 인수하기 위한 확정 합병 계약을 체결했으며, Kineta의 혁신적인 항체 KVA12123에 대한 권리를 확보했습니다. 이 인수는 TuHURA의 파이프라인에 2상 신규 체크포인트 억제제를 추가하며, 2025년에 변이 NPM1 AML에 대한 2a/b상 시험을 계획하고 있습니다.
KVA12123는 VISTA를 차단하는 면역 요법으로, 매 2주마다 단클론 항체 주입으로 투여됩니다. 본 약물은 단독 요법 군에서 등록을 완료했으며, 1000mg 용량에서의 안전성을 입증하고 있으며, KEYTRUDA®와의 병용 요법 시험을 마무리하고 있습니다. 2024년 7월에 지급된 500만 달러의 독점성 수수료를 통해 이루어지는 본 거래는 2025년 1분기에 완료될 것으로 예상됩니다.
TuHURA Biosciences (NASDAQ:HURA) a signé un accord de fusion définitif pour acquérir Kineta, Inc. (OTC PINK:KANT), obtenant les droits sur l'anticorps novateur KVA12123 de Kineta. Cette acquisition ajoute un inhibiteur de point de contrôle novateur de phase 2 au pipeline de TuHURA, avec des plans pour un essai de phase 2a/b sur la leucémie myéloïde aiguë (LMA) mutée NPM1 en 2025.
KVA12123 est une immunothérapie bloquant VISTA, administrée par infusion d'anticorps monoclonaux tous les quinze jours. L'inscription dans son bras de monothérapie est terminée, démontrant la sécurité à un niveau de dose de 1000 mg, et se termine avec des essais de thérapie combinée avec KEYTRUDA®. La transaction, à la suite d'un paiement de 5 millions de dollars d'exclusivité effectué en juillet 2024, devrait être finalisée au premier trimestre 2025.
TuHURA Biosciences (NASDAQ:HURA) hat einen verbindlichen Fusionsvertrag zur Übernahme von Kineta, Inc. (OTC PINK:KANT) unterzeichnet und sich die Rechte an dem neuartigen Antikörper KVA12123 von Kineta gesichert. Die Übernahme ergänzt TuHURAs Pipeline um einen neuartigen Checkpoint-Inhibitor der Phase 2, mit Plänen für eine Phase 2a/b-Studie bei mutiertem NPM1 AML im Jahr 2025.
KVA12123 ist eine VISTA-blockierende Immuntherapie, die alle zwei Wochen als Infusion von monoklonalen Antikörpern verabreicht wird. Die Einschreibung in den Monotherapiearm wurde abgeschlossen, wobei eine Sicherheit auf dem Doseniveau von 1000 mg demonstriert wurde, und es werden Kombinationsstudien mit KEYTRUDA® abgeschlossen. Die Transaktion, nach einer Zahlung von 5 Millionen Dollar für Exklusivität im Juli 2024, wird voraussichtlich im ersten Quartal 2025 abgeschlossen.
- Acquisition of KVA12123, a Phase 2-ready checkpoint inhibitor with demonstrated safety profile
- Strategic expansion into blood cancer treatment market, particularly AML
- Synergistic combination potential with existing TuHURA technologies
- KVA12123 shows strong monotherapy tumor growth inhibition without cytokine release syndrome
- Additional capital requirements for Phase 2a/b trials in 2025
- Merger completion uncertainty pending Q1 2025 closing
- Integration risks between two different technology platforms
Insights
This merger represents a strategic move in the immuno-oncology space, with TuHURA acquiring Kineta's promising VISTA-blocking antibody KVA12123. The acquisition's value lies in the Phase 2-ready checkpoint inhibitor that has shown strong preclinical results without the cytokine release syndrome issues that have plagued competitors. The focus on mutated NPM1 AML provides a clear path forward, particularly given the correlation between NPM1 mutations and elevated VISTA expression.
The deal builds on TuHURA's
This acquisition positions TuHURA strategically in the competitive checkpoint inhibitor market, particularly in blood cancers. The deal structure, combining cash and stock, helps preserve capital while providing Kineta shareholders with upside potential. The prior
The timing aligns with positive clinical data presented at ASH 2024, potentially reducing development risk. The focus on AML with NPM1 mutations represents a targeted market opportunity with less competition than solid tumors. The potential synergies with TuHURA's existing pipeline could create operational efficiencies and enhanced development capabilities.
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 / ACCESSWIRE / 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
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."
About the 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
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
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
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.
About Kineta
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 www.kinetabio.com.
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.
Participants in the Solicitation
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."
No Offer or Solicitation
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 include, but are not limited to: the completion of the Proposed Transaction on anticipated terms and timing, anticipated tax treatment and unforeseen liabilities, future capital expenditures, revenues, expenses, earnings, synergies, economic performance, indebtedness, financial condition, losses, pricing trends, future prospects, credit ratings, business and management strategies which may adversely affect each of TuHURA's and Kineta's business, financial condition, operating results and the price of their respective common stocks; the failure to satisfy the conditions to the completion of the Proposed Transaction, including the adoption of the merger agreement by the stockholders of Kineta and TuHURA's completion of a financing transaction, in a timely manner, or at all, or the failure to satisfy any of the other conditions to the completion of the Proposed Transaction, or unexpected delays in satisfying any conditions; uncertainties related to Kineta's cash level and ability to continue as a going concern; the price of TuHURA common stock and Kineta common stock could change before the completion of the Proposed Transaction, including as a result of uncertainty as to the long-term value of the common stock of TuHURA or as a result of broader stock market movements; risks relating to the amount of Kineta's estimated net working capital at the closing of the Proposed Transaction, including any resulting reduction or adjustments to the merger consideration or failure to satisfy the condition that Kineta's estimated net working capital deficit not exceed
You should carefully consider the foregoing factors and the other risks and uncertainties that affect the businesses of TuHURA and Kineta described in the "Risk Factors" section of their respective Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents filed by either of them from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. All forward-looking statements by their nature address matters that involve risks and uncertainties, many of which are beyond TuHURA's and Kineta's control, and are not guarantees of future results. Readers are cautioned not to put undue reliance on forward-looking statements, and TuHURA and Kineta assume no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law. Neither TuHURA nor Kineta gives any assurance that either TuHURA or Kineta will achieve its expectations.
Investor/Media Contacts:
TuHURA Biosciences, Inc.
Jenene Thomas
JTC Team, LLC
908.824.0775
tuhura@jtcir.com
Kineta, Inc.
Investor Relations
info@kineta.us
SOURCE: TuHURA Biosciences, Inc.
View the original press release on accesswire.com
FAQ
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