TuHURA Biosciences Completes Merger Transaction with Kintara Therapeutics
TuHURA Biosciences has completed its merger with Kintara Therapeutics, creating a Phase 3 registration-stage immune-oncology company. The combined entity will operate as TuHURA Biosciences, Inc. and trade on Nasdaq under the ticker "HURA" starting October 18, 2024. The company's focus is on developing novel technologies to overcome resistance to cancer immunotherapy, with a lead program entering a single Phase 3 accelerated approval registration trial in the first half of 2025 for first-line Merkel Cell carcinoma treatment.
The merger includes a $31 million fully-funded financing, expected to support operations into late 2025. Post-merger, former Kintara equityholders own approximately 2.85% of the combined company, while TuHURA equityholders own about 97.15%. The company's pipeline includes Immune Fx (IFx) Innate Immune Response Agonists and Tumor Microenvironment Modulators, aimed at overcoming primary and acquired resistance to cancer immunotherapies.
TuHURA Biosciences ha completato la sua fusione con Kintara Therapeutics, creando un azienda di oncologia immunitaria in fase di registrazione di Fase 3. L'entità combinata opererà come TuHURA Biosciences, Inc. e sarà quotata al Nasdaq con il ticker "HURA" a partire dal 18 ottobre 2024. L'azienda si concentra sullo sviluppo di tecnologie innovative per superare la resistenza alla immunoterapia oncologica, con un programma principale che entrerà in una singola sperimentazione di registrazione accelerata di Fase 3 nella prima metà del 2025 per il trattamento del carcinoma a cellule di Merkel in prima linea.
La fusione include un finanziamento completamente finanziato di 31 milioni di dollari, che si prevede supporterà le operazioni fino alla fine del 2025. Dopo la fusione, i precedenti azionisti di Kintara possiedono circa il 2,85% della società combinata, mentre gli azionisti di TuHURA possiedono circa il 97,15%. Il portafoglio dell'azienda include agonisti della risposta immunitaria innata Immune Fx (IFx) e modulatori del microambiente tumorale, mirati a superare la resistenza primaria e acquisita alle terapie immunologiche contro il cancro.
TuHURA Biosciences ha completado su fusión con Kintara Therapeutics, creando una compañía de oncología inmunitaria en la etapa de registro de Fase 3. La entidad combinada operará como TuHURA Biosciences, Inc. y se cotizará en Nasdaq bajo el símbolo "HURA" a partir del 18 de octubre de 2024. La empresa se centra en desarrollar tecnologías novedosas para superar la resistencia a la inmunoterapia contra el cáncer, con un programa principal que ingresará en un ensayo de registro acelerado de Fase 3 en la primera mitad de 2025 para el tratamiento del carcinoma de células de Merkel en primera línea.
La fusión incluye un financiamiento totalmente financiado de 31 millones de dólares, que se espera apoye las operaciones hasta finales de 2025. Tras la fusión, los antiguos accionistas de Kintara poseen aproximadamente el 2.85% de la empresa combinada, mientras que los accionistas de TuHURA poseen alrededor del 97.15%. El pipeline de la empresa incluye Agonistas de la Respuesta Inmunitaria Innata Immune Fx (IFx) y Modificadores del Microambiente Tumoral, destinados a superar la resistencia primaria y adquirida a las inmunoterapias contra el cáncer.
TuHURA Biosciences가 Kintara Therapeutics와의 합병을 완료하여 3상 등록 단계의 면역 종양학 회사를 설립했습니다. 결합된 법인은 TuHURA Biosciences, Inc.로 운영되며 "HURA"라는 티커로 Nasdaq에서 2024년 10월 18일부터 거래됩니다. 이 회사는 암 면역요법에 대한 저항을 극복하기 위한 새로운 기술을 개발하는 데 집중하고 있으며, 2025년 상반기에 1상 종양세포 치료를 위한 단일 3상 조기 승인 등록 시험에 진입할 계획입니다.
합병에는 3,100만 달러의 완전 자금 지원 금융이 포함되어 있으며, 이는 2025년 말까지 운영을 지원할 것으로 예상됩니다. 합병 후 이전 Kintara 주주들은 결합된 회사의 약 2.85%를 소유하고, TuHURA 주주들은 약 97.15%를 소유하게 됩니다. 이 회사의 파이프라인에는 면역 Fx (IFx) 내재 면역 반응 촉진제와 종양 미세환경 조절제가 포함되어 있으며, 이는 암 면역요법에 대한 1차 및 후천적 저항을 극복하는 것을 목표로 하고 있습니다.
TuHURA Biosciences a achevé sa fusion avec Kintara Therapeutics, créant une entreprise d'oncologie immunitaire en phase d'enregistrement de phase 3. L'entité combinée opérera sous le nom de TuHURA Biosciences, Inc. et sera cotée au Nasdaq sous le symbole "HURA" à partir du 18 octobre 2024. L'entreprise se concentre sur le développement de technologies novatrices pour surmonter la résistance aux immunothérapies contre le cancer, avec un programme principal entrant dans un essai d'enregistrement accéléré de phase 3 dans la première moitié de 2025 pour le traitement du carcinome à cellules de Merkel en première ligne.
La fusion comprend un financement entièrement financé de 31 millions de dollars, qui devrait soutenir les opérations jusqu'à fin 2025. Après la fusion, les anciens actionnaires de Kintara possèdent environ 2,85 % de l'entreprise combinée, tandis que les actionnaires de TuHURA possèdent environ 97,15 %. Le pipeline de l'entreprise comprend des agonistes de la réponse immunitaire innée Immune Fx (IFx) et des modulateurs du microenvironnement tumoral, visant à surmonter la résistance primaire et acquise aux immunothérapies contre le cancer.
TuHURA Biosciences hat seine Fusion mit Kintara Therapeutics abgeschlossen und eine Unternehmen für immunonkologische Therapien in der Phase 3 der Registrierung gegründet. Die kombinierte Einheit wird als TuHURA Biosciences, Inc. tätig sein und ab dem 18. Oktober 2024 unter dem Ticker "HURA" an der Nasdaq gehandelt. Der Fokus des Unternehmens liegt auf der Entwicklung neuartiger Technologien zur Überwindung von Resistenzen gegen Krebsimmuntherapien, wobei ein führendes Programm in eine einzelne Phase-3-Beschleunigungs-Zulassungsstudie im ersten Halbjahr 2025 zur Behandlung des Merkelzellkarzinoms in der ersten Linie eintreten wird.
Die Fusion beinhaltet eine vollständig finanzierte Finanzierung von 31 Millionen Dollar, die voraussichtlich die Operationen bis Ende 2025 unterstützen wird. Nach der Fusion besitzen die ehemaligen Kintara-Aktionäre etwa 2,85% des kombinierten Unternehmens, während die TuHURA-Aktionäre etwa 97,15% besitzen. Die Pipeline des Unternehmens umfasst Immune Fx (IFx) Agonisten der angeborenen Immunantwort und Tumormikroumgebungsmodulatoren, die darauf abzielen, primäre und erworbene Resistenzen gegen Immuntherapien bei Krebs zu überwinden.
- Merger completion creates a Phase 3 registration-stage immune-oncology company
- $31 million fully-funded financing to support operations into late 2025
- Lead program entering Phase 3 trial in first half of 2025 for Merkel Cell carcinoma treatment
- Special Protocol Assessment (SPA) agreement with FDA for the Phase 3 trial
- Novel technologies targeting major obstacles in cancer immunotherapy effectiveness
- Significant dilution for former Kintara shareholders, owning only 2.85% of the combined company
Insights
The merger between TuHURA Biosciences and Kintara Therapeutics marks a significant development in the immuno-oncology space. Key financial aspects include:
- A
$31 million fully-funded financing, providing runway into late 2025 - Post-merger ownership structure: TuHURA equityholders own
97.15% , Kintara equityholders2.85% (potentially increasing to5.45% if CVR milestones are met) - Nasdaq listing under ticker "HURA", enhancing visibility and potential liquidity
The combined entity's focus on a Phase 3 trial for Merkel Cell carcinoma treatment, with potential FDA approval, could be a significant value driver. However, investors should note the high risk and capital-intensive nature of late-stage clinical trials in oncology. The company's novel approach to overcoming immunotherapy resistance could be groundbreaking if successful, but requires careful monitoring of clinical progress and cash burn rate.
TuHURA's pipeline presents an innovative approach to addressing major challenges in cancer immunotherapy:
- IFx-2.0: A pDNA/mRNA-based therapy targeting primary resistance to checkpoint inhibitors
- Tumor Microenvironment Modulators: Bi-specific immune modulating conjugates targeting Myeloid Derived Suppressor Cells
The planned Phase 3 trial for IFx-2.0 in Merkel Cell Carcinoma under an SPA agreement with the FDA is particularly noteworthy. This accelerated approval pathway could significantly reduce time-to-market if successful. The combination with Keytruda® (pembrolizumab) aligns with current trends in combination immunotherapies. The potential to expand into additional oncology indications adds to the therapy's promise. However, investors should be aware that even with promising preclinical and early clinical data, success in Phase 3 trials is never guaranteed in oncology.
Combined company will operate as TuHURA Biosciences, Inc. and advance pipeline of novel technologies to overcome resistance to cancer immunotherapy
Lead program entering single Phase 3 accelerated approval registration trial in first half of 2025 for treatment of 1st line Merkel Cell carcinoma under Special Protocol Assessment (SPA) agreement with FDA
$31 million fully-funded financing in connection with the merger agreement expected to fund planned operations of the combined company into late 2025Combined company to commence trading on The Nasdaq Capital Market under the ticker "HURA" on October 18, 2024
TAMPA, FL / ACCESSWIRE / October 17, 2024 / TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 registration-stage immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy today announced the completion of its previously announced merger with Kintara Therapeutics, Inc. (now TuHURA Biosciences, Inc.). The combined company will operate under the name "TuHURA Biosciences, Inc." and will focus on advancing TuHURA's innate immune response agonists and tumor microenvironment modulators, two technologies that seek to overcome the major obstacles that limit the effectiveness of current immunotherapies in treating cancer. The Company is preparing to initiate a single Phase 3 accelerated approval registration trial in the first half of 2025 for treatment of 1st line Merkel Cell carcinoma under SPA agreement with FDA.
The shares of the Company's common stock, previously trading under the ticker symbol "KTRA," will commence trading on a post-reverse split and post-business combination basis, on The Nasdaq Capital Market under the ticker symbol "HURA", effective October 18, 2024. The Company's common stock is now represented by a new CUSIP number, 898920103.
As a result of the merger, post-merger Kintara equityholders collectively own approximately
"This marks a transformational milestone for both companies and is a significant step in the evolution of TuHURA. As we look to the future, which I believe has never been brighter, we are working to solve a significant issue with current cancer immunotherapies," commented Dr. James Bianco, President and Chief Executive Officer of TuHURA. "Our novel technologies are designed to overcome resistance to cancer immunotherapy, and we are planning to initiate a single Phase 3 accelerated approval registration trial in the first half of 2025 with our lead innate immune response agonist, IFx-2.0. If successful, not only does it provide the ability to target additional oncology indications but also unlocks tremendous value for all stakeholders."
Advancing Novel Technologies to Overcome Resistance to Cancer Immunotherapy
TuHURA is a Phase 3 registration-stage immuno-oncology company developing novel technologies to overcome primary and acquired resistance -- two major obstacles to cancer immunotherapy's ability to treat and cure cancer.
Immune Fx (IFx) Innate Immune Response Agonists: TuHURA's IFx technology utilizes a proprietary plasmid DNA ("pDNA") or messenger RNA ("mRNA") which, when introduced into or targeted to a tumor cell, results in the expression of a highly immunogenic bacterial protein (Emm55) on the surface of the tumor cell. TuHURA's lead innate immune response agonist candidate, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA is preparing to initiate a single Phase 3 accelerated approval 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 under a SPA agreement with the US FDA, in the first half of2025.
Tumor Microenvironment Modulators: Leveraging its Delta receptor technology, TuHURA is developing bi-specific immune modulating Antibody (ADC) or Peptide (PDC) Drug Conjugates targeting Myeloid Derived Suppressor Cells to inhibit their immune suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies.
About the Transaction
Under the terms of the merger agreement, Kayak Mergeco, Inc., Kintara's wholly-owned subsidiary, will merge with and into the private-company TuHURA, with TuHURA surviving the merger and becoming the combined company's direct, wholly-owned subsidiary effective at 12:03 AM Eastern Time on October 18, 2024.
As previously announced, in connection with the merger and pursuant to the Contingent Value Rights Agreement (the "CVR Agreement"), the Company will issue CVRs to legacy Kintara stockholders (or in the case of warrants to purchase shares of Kintara common stock, each share of Kintara common stock for which such warrant to purchase shares of Kintara stock is exercisable), entitling such holders to an aggregate of approximately 1,539,918 shares of the combined company's common stock on a post-split basis, upon the achievement of certain milestones as set forth in the CVR Agreement.
The combined company will be led by James Bianco as President and Chief Executive Officer of TuHURA. In addition to Mr. Bianco, the TuHURA leadership team includes current members of management Dan Dearborn as Chief Financial Officer and Dennis Yamashita as Chief Scientific Officer.
The Board of Directors of TuHURA will be composed of James Bianco, James Manuso, Alan List, George Ng and Robert Hoffman.
Advisors
Lucid Capital Markets, LLC acted as the exclusive financial advisor and Lowenstein Sandler LLP acted as legal counsel to Kintara. H.C. Wainwright & Co. acted as the exclusive financial advisor and Foley & Lardner LLP acted as legal counsel to TuHURA.
About TuHURA Biosciences, Inc.
TuHURA Biosciences, Inc. is a Phase 3 registration-stage immuno-oncology company developing novel technologies to overcome resistance to cancer immunotherapy. TuHURA's lead innate immune response 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 response 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 tumor microenvironment 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.
Forward-Looking Statements
This news release contains forward-looking statements that are not historical facts within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and other future conditions. In some cases you can identify these statements by forward-looking words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "could," "should," "would," "project," "plan," "expect," "goal," "seek," "future," "likely" or the negative or plural of these words or similar expressions. Examples of such forward-looking statements include but are not limited to express or implied statements regarding Kintara's or TuHURA's management team's expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding: the Proposed Transaction and the expected effects, perceived benefits or opportunities and related timing with respect thereto, expectations regarding clinical trials and research and development programs, in particular with respect to TuHURA's IFx-Hu2.0 product candidate and its TME modulators development program, and any developments or results in connection therewith; the anticipated timing of the results from those studies and trials; expectations regarding the use of capital resources, including the net proceeds from the fully-funded financing; the time period over which the combined company's capital resources will be sufficient to fund its anticipated operations; and the expected trading of the combined company's stock on the Nasdaq Capital Market. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in these forward-looking statements. Factors that could cause actual results to differ materially from these forward-looking statements are described in the "Risk Factors" section of Kintara's Annual Report on Form 10-K for the fiscal year ended June 30, 2023 filed with the SEC and the proxy statement/prospectus dated August 19, 2024, as supplemented. Additional assumptions, risks and uncertainties are described in detail in our registration statements, reports and other filings with the SEC, which are available on the combined company's website, and at www.sec.gov.
You are cautioned that such statements are not guarantees of future performance and that our actual results may differ materially from those set forth in the forward-looking statements. The forward-looking statements and other information contained in this news release are made as of the date hereof and Kintara does not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. Nothing herein shall constitute an offer to sell or the solicitation of an offer to buy any securities.
Investor Contact:
Jenene Thomas
JTC Team, LLC
tuhura@jtcir.com
SOURCE: TuHURA Biosciences, Inc.
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