Welcome to our dedicated page for TuHURA Biosciences news (Ticker: HURA), a resource for investors and traders seeking the latest updates and insights on TuHURA Biosciences stock.
TuHURA Biosciences develops immuno-oncology therapeutics designed to address resistance to cancer immunotherapies. Company news centers on its clinical-stage pipeline, including IFx-2.0, an innate immune agonist being studied as adjunctive therapy with Keytruda in advanced or metastatic Merkel Cell Carcinoma, and TBS-2025, a VISTA-inhibiting monoclonal antibody for mutNPM1 relapsed or refractory acute myeloid leukemia.
Recurring updates also cover the Delta Opioid Receptor technology used in immune-modulating antibody drug conjugates and antibody peptide conjugates targeting Myeloid Derived Suppressor Cells. Other company developments include financial results, clinical operations leadership, investor-conference communications, financing arrangements and Nasdaq listing compliance matters.
TuHURA Biosciences (NASDAQ: HURA) has appointed Dr. Bertrand Le Bourdonnec as Executive Vice President, Head of Drug Discovery, Early Development, and Program Management. Dr. Le Bourdonnec brings a 20-year career in drug discovery with impressive achievements, including 12 pre-clinical/clinical candidates and 7 investigational new drug applications.
His expertise in Delta Opioid Receptor (DOR) biochemistry and pharmacology aligns perfectly with TuHURA's Antibody Drug Conjugate (ADC) and Antibody Peptide Conjugate (APC) technology platform. Notable achievements include developing first-in-class spirocyclic DOR agonists licensed to Pfizer and leading the benevopran program to positive Phase IIb results, which led to Adolor 's acquisition by Cubist Pharmaceuticals.
Previously, he served as Chief Scientific Officer at HDAX Therapeutics and VP roles at Deciphera Pharmaceuticals and Cubist Pharmaceuticals, demonstrating successful leadership in drug development across multiple therapeutic areas including oncology, pain, and neurodegenerative diseases.
TuHURA Biosciences (NASDAQ:HURA) reported its fiscal year 2024 results and corporate updates. The company plans to initiate enrollment in Phase 3 IFx-2.0 trial for advanced Merkel cell carcinoma in Q2 2025, conducted under Special Protocol Assessment Agreement with FDA. The trial will test IFx-2.0 as adjunctive therapy with Keytruda®.
Key financial highlights include R&D expenses of $13.3 million (up from $9.4 million in 2023) and G&A expenses of $4.3 million (slight increase from $4.1 million in 2023). The company raised $36 million in 2024 to fund operations through late Q4 2025.
Notable developments include:
- Planned acquisition of Kineta's Phase 2 ready VISTA inhibitor, expected to close in Q2 2025
- NASDAQ listing achievement via reverse merger
- Expansion of discovery team for immune modulating Antibody Drug/Peptide Conjugate Program
TuHURA Biosciences (NASDAQ:HURA) has appointed Craig L. Tendler, M.D. to its Board of Directors effective March 10, 2025. Dr. Tendler, former Vice President of Oncology Clinical Development at Johnson & Johnson, brings significant expertise having overseen 30 major drug approvals and 13 FDA Breakthrough Designations.
This strategic appointment comes as TuHURA prepares to advance IFx-2.0 through its registrational Phase 3 clinical trial, planned for Q2 2025. The company focuses on developing novel technologies to overcome resistance to cancer immunotherapy. Dr. Tendler's experience includes overseeing worldwide approvals for treatments in prostate cancer, hematologic malignancies, lung cancer, and bladder cancer.
The appointment aligns with TuHURA's recent agreement with Kineta to acquire its VISTA inhibiting antibody, and their discovery of the delta opioid receptor's role in controlling immune suppressing capabilities of myeloid derived suppressor cells and tumor associated M2 polarized macrophages.
TuHURA Biosciences (NASDAQ:HURA), a Phase 3 registration-stage immuno-oncology company, has announced its participation in the 37th Annual ROTH Conference in Dana Point, CA. The company's President and CEO, James A. Bianco, M.D., will engage in a fireside chat on March 18, 2025, at 8:30 AM PT.
TuHURA, which focuses on developing novel technologies to overcome resistance to cancer immunotherapy, will make the presentation available via live webcast on their company website's Investors section. Additionally, the management team will be available for one-on-one meetings with qualified registered conference attendees.
TuHURA Biosciences (NASDAQ: HURA), a Phase 3 registration-stage immune-oncology company, announced its participation in the Virtual Investor 'Top 5 for '25' On-Demand Conference. During the event, CEO James Bianco presented the top five reasons why investors and industry colleagues should focus on TuHURA in 2025. The presentation is now available for viewing on the company's website and through a direct webcast link.
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) announced significant developments, including a Phase 3 accelerated approval registration trial for IFx-2.0 in first-line treatment of Merkel Cell Carcinoma, planned for first half of 2025. The company entered a non-binding letter of intent to acquire Kineta's KVA12123, a Phase 2 ready VISTA inhibiting antibody. TuHURA is advancing IFx-3.0, a tumor-targeted mRNA innate immune response agonist, and developing early discovery programs for bi-specific antibody drug conjugates. The company secured $31 million in financing through a merger with Kintara, funding operations into late 2025, and raised an additional $5 million for the potential Kineta acquisition.
TuHURA Biosciences (Nasdaq: HURA), a Phase 3 registration-stage immune-oncology company, announced its participation in the 2024 Maxim Healthcare Virtual Summit. Dr. James Bianco, President and CEO of TuHURA, was part of the Precision and Immune Oncology panel. The company focuses on developing novel technologies to overcome resistance to cancer immunotherapy. A webcast replay of the panel presentation is available for M-Vest members.
TuHURA Biosciences (NASDAQ:HURA), a Phase 3 registration-stage immune-oncology company, will present at the Virtual Investor "New to the Street" Event on October 30, 2024, at 4:00 PM ET. Dr. Jim Bianco, President and CEO, will provide a corporate overview and business outlook during a live moderated webcast.
Investors can submit questions live during the event, with the company aiming to answer as many as possible. The presentation will be available on TuHURA's website, with a replay accessible for 90 days following the live event.
TuHURA focuses on developing novel technologies to overcome resistance to cancer immunotherapy. This event offers an opportunity for investors to gain insights into the company's progress and future plans in the immune-oncology field.
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.