TuHURA Biosciences Files INDA for TBS-2025 with FDA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Feb 17 2026
0mins
Should l Buy HURA?
TuHURA Biosciences has filed an Investigational New Drug Application, or INDA, with the FDA's Division of Hematologic Malignancies 1 for the study of TBS-2025, a novel VISTA inhibiting antibody, for the treatment of mutNPM1 relapsed/refractory Acute Myeloid Leukemi, or AML, in combination with a menin inhibitor. TBS-2025 is a unique VISTA-inhibiting monoclonal antibody acquired by the company in its acquisition by merger with Kineta on June 30, 2025. The company plans on initiating a Phase 2 study in menin inhibitor naive patients with mutNPM1 r/r AML utilizing a Simon 2 stage design. Pending completion of FDA review and clearance, the company currently targets initiating the Phase 2 study in early Q2 with preliminary Stage 1 results in Q3.
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Analyst Views on HURA
Wall Street analysts forecast HURA stock price to rise
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 2.830
Low
8.00
Averages
9.00
High
10.00
Current: 2.830
Low
8.00
Averages
9.00
High
10.00
About HURA
TuHURA Biosciences, Inc. is a Phase III registration-stage immuno-oncology company developing novel technologies to overcome resistance to cancer immunotherapy. Its lead innate immune agonist, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. It has initiated a single randomized placebo-controlled Phase III registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda (pembrolizumab) compared to Keytruda plus placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma. It is leveraging its Delta Opioid Receptor technology to develop bi-specific antibody drug conjugates and antibody peptide 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. It is also focused on the novel VISTA inhibiting mAb, known as TBS-2025.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
TuHURA Secures $50 Million Credit Facility for Pipeline Development
- Credit Facility Overview: TuHURA Biosciences has entered into a loan agreement with its largest shareholder, K&V Investment One LLC, providing up to $50 million in funding to support clinical trials and general operations, reflecting shareholder confidence in the company's strategy.
- Flexible Fund Utilization: Under the agreement, TuHURA can draw funds monthly as needed at an interest rate of 12%, allowing the company to manage cash flow flexibly ahead of key milestones, ensuring ongoing clinical development.
- Strategic Implications: This financing not only provides TuHURA with a non-equity source of capital but also secures funding for the critical Phase 3 results of its IFx-2.0 program, potentially accelerating the product's market entry and enhancing competitive positioning.
- Future Outlook: TuHURA plans to leverage this funding to support the development of its TBS-2025 project, further expanding its technological edge in immuno-oncology, which is expected to yield long-term commercial success for the company.
See More
TuHURA Secures $50 Million Credit Facility for Pipeline Development
- Credit Facility Overview: TuHURA Biosciences has entered into a loan agreement with its largest shareholder, K&V Investment One LLC, providing up to $50 million in funding to support clinical trials and corporate operations, reflecting strong confidence in its development pipeline.
- Loan Terms Details: The facility bears a 12% annual interest rate, allowing the company to draw funds monthly as needed, ensuring principal repayment by the five-year maturity date of April 21, 2031, which enhances the company's financial flexibility.
- Strategic Implications: This financing method not only avoids shareholder dilution but also provides TuHURA with operational capital ahead of key milestones, particularly for its Phase 3 clinical trial of IFx-2.0, potentially accelerating the product's market entry.
- Market Confidence Boost: The CEO stated that this financing reflects the largest shareholder's confidence in the company's strategy, which is expected to drive clinical and commercial success for IFx-2.0, further solidifying its market position in immuno-oncology.
See More
TuHURA Appoints New SVP of Clinical Operations
- New Executive Appointment: TuHURA Biosciences has appointed Amanda Garofalo as Senior Vice President of Clinical Operations, bringing over 20 years of drug development experience, which is expected to enhance the efficiency of the company's clinical programs.
- Advancing Clinical Programs: Garofalo will closely collaborate with CEO James Bianco and Dr. Craig Tendler to drive the Phase 3 accelerated approval trial of IFx-2.0 and the Phase 1b/2 trial of TBS-2025, aiding the company in achieving its clinical milestones.
- Rich Industry Background: Prior to joining TuHURA, Garofalo was instrumental in executing a $305 million Series F funding round at Parabilis Medicines, showcasing her exceptional capabilities in clinical trial and data management, which is anticipated to optimize TuHURA's resource utilization.
- Diverse Professional Experience: Garofalo managed over 200 oncology clinical trials at EMD Serono and successfully directed multiple new IND submissions, demonstrating her extensive experience across all stages of drug development, which will provide robust support for TuHURA's R&D strategy.
See More
TuHURA Biosciences Reports FY Net Loss of $30.05 Million
- Annual Financial Performance: TuHURA Biosciences reported a net loss of $30.05 million for the fiscal year, indicating significant pressure in market competition and challenges in profitability, which could impact future financing and investor confidence.
- Financial Data Analysis: Despite the losses, the company's financial information suggests that TuHURA is actively seeking to improve operational efficiency and cost control, aiming for profitability in the future to enhance its competitive position in the market.
- Market Reaction: Investors have reacted lukewarmly to TuHURA's financial performance, which may lead to downward pressure on stock prices, further affecting the company's capital-raising capabilities and market positioning.
- Future Outlook: The company needs to develop effective strategies to address current financial challenges, particularly in R&D and marketing, to maintain competitiveness and achieve sustainable growth in the biotechnology sector.
See More
TuHURA Biosciences Reports Strong 2025 Financial Results and Strategic Developments
- Strong Financial Performance: TuHURA Biosciences reported cash and cash equivalents of $3.6 million for 2025, with an additional $7.5 million raised in Q1 2026 through a registered direct offering, enhancing financial flexibility to support ongoing R&D efforts.
- Increased R&D Spending: Research and development expenses rose to $20.5 million in 2025 from $13.3 million in 2024, reflecting the company's commitment to advancing its clinical development and novel therapeutics in immuno-oncology, aiming to accelerate project timelines.
- Clinical Trial Progress: The Phase 3 study of IFx-2.0 is currently enrolling, with completion anticipated by mid-2027, which will significantly bolster the company's competitive edge in the cancer immunotherapy market.
- Enhanced Strategic Leadership: The appointment of Dr. Craig Tendler to oversee clinical development strategy and operations aims to leverage his extensive experience to advance the VISTA inhibiting antibody TBS-2025, thereby strengthening the company's R&D capabilities and market positioning.
See More
TuHURA Biosciences Appoints New CMO to Drive Oncology Strategy
- Executive Appointment: TuHURA Biosciences has appointed Dr. Craig L. Tendler as Chief Medical Officer (CMO), who will oversee clinical development strategy and operations, leveraging his 30 years of experience in oncology to advance the TBS-2025 program, which is expected to significantly enhance the company's competitiveness in blood-related cancer treatments.
- Regulatory Approval Achievements: Dr. Tendler has coordinated over 30 regulatory approvals and 15 new medical entity approvals in oncology, including four biologic or cell therapy approvals, generating over $16 billion in global sales, highlighting his substantial impact in the industry.
- Clinical Development Plans: TuHURA's TBS-2025 project has received preliminary feedback from the FDA, and Dr. Tendler will utilize his extensive experience in NPM1 mutated acute myeloid leukemia (AML) to accelerate the clinical development of this drug, aiming to improve overall survival rates for patients.
- Strategic Collaboration and Investment: Dr. Tendler's successful tenure at Johnson & Johnson, including collaborations with the FDA and EMA to secure global approvals for transformative therapies, will provide invaluable strategic guidance for TuHURA's future development, particularly in the complex landscape of oncology drug development.
See More
TuHURA Secures $50 Million Credit Facility for Pipeline Development
- Credit Facility Overview: TuHURA Biosciences has entered into a loan agreement with its largest shareholder, K&V Investment One LLC, providing up to $50 million in funding to support clinical trials and general operations, reflecting shareholder confidence in the company's strategy.
- Flexible Fund Utilization: Under the agreement, TuHURA can draw funds monthly as needed at an interest rate of 12%, allowing the company to manage cash flow flexibly ahead of key milestones, ensuring ongoing clinical development.
- Strategic Implications: This financing not only provides TuHURA with a non-equity source of capital but also secures funding for the critical Phase 3 results of its IFx-2.0 program, potentially accelerating the product's market entry and enhancing competitive positioning.
- Future Outlook: TuHURA plans to leverage this funding to support the development of its TBS-2025 project, further expanding its technological edge in immuno-oncology, which is expected to yield long-term commercial success for the company.
See More
TuHURA Secures $50 Million Credit Facility for Pipeline Development
- Credit Facility Overview: TuHURA Biosciences has entered into a loan agreement with its largest shareholder, K&V Investment One LLC, providing up to $50 million in funding to support clinical trials and corporate operations, reflecting strong confidence in its development pipeline.
- Loan Terms Details: The facility bears a 12% annual interest rate, allowing the company to draw funds monthly as needed, ensuring principal repayment by the five-year maturity date of April 21, 2031, which enhances the company's financial flexibility.
- Strategic Implications: This financing method not only avoids shareholder dilution but also provides TuHURA with operational capital ahead of key milestones, particularly for its Phase 3 clinical trial of IFx-2.0, potentially accelerating the product's market entry.
- Market Confidence Boost: The CEO stated that this financing reflects the largest shareholder's confidence in the company's strategy, which is expected to drive clinical and commercial success for IFx-2.0, further solidifying its market position in immuno-oncology.
See More
TuHURA Appoints New SVP of Clinical Operations
- New Executive Appointment: TuHURA Biosciences has appointed Amanda Garofalo as Senior Vice President of Clinical Operations, bringing over 20 years of drug development experience, which is expected to enhance the efficiency of the company's clinical programs.
- Advancing Clinical Programs: Garofalo will closely collaborate with CEO James Bianco and Dr. Craig Tendler to drive the Phase 3 accelerated approval trial of IFx-2.0 and the Phase 1b/2 trial of TBS-2025, aiding the company in achieving its clinical milestones.
- Rich Industry Background: Prior to joining TuHURA, Garofalo was instrumental in executing a $305 million Series F funding round at Parabilis Medicines, showcasing her exceptional capabilities in clinical trial and data management, which is anticipated to optimize TuHURA's resource utilization.
- Diverse Professional Experience: Garofalo managed over 200 oncology clinical trials at EMD Serono and successfully directed multiple new IND submissions, demonstrating her extensive experience across all stages of drug development, which will provide robust support for TuHURA's R&D strategy.
See More
TuHURA Biosciences Reports FY Net Loss of $30.05 Million
- Annual Financial Performance: TuHURA Biosciences reported a net loss of $30.05 million for the fiscal year, indicating significant pressure in market competition and challenges in profitability, which could impact future financing and investor confidence.
- Financial Data Analysis: Despite the losses, the company's financial information suggests that TuHURA is actively seeking to improve operational efficiency and cost control, aiming for profitability in the future to enhance its competitive position in the market.
- Market Reaction: Investors have reacted lukewarmly to TuHURA's financial performance, which may lead to downward pressure on stock prices, further affecting the company's capital-raising capabilities and market positioning.
- Future Outlook: The company needs to develop effective strategies to address current financial challenges, particularly in R&D and marketing, to maintain competitiveness and achieve sustainable growth in the biotechnology sector.
See More
TuHURA Biosciences Reports Strong 2025 Financial Results and Strategic Developments
- Strong Financial Performance: TuHURA Biosciences reported cash and cash equivalents of $3.6 million for 2025, with an additional $7.5 million raised in Q1 2026 through a registered direct offering, enhancing financial flexibility to support ongoing R&D efforts.
- Increased R&D Spending: Research and development expenses rose to $20.5 million in 2025 from $13.3 million in 2024, reflecting the company's commitment to advancing its clinical development and novel therapeutics in immuno-oncology, aiming to accelerate project timelines.
- Clinical Trial Progress: The Phase 3 study of IFx-2.0 is currently enrolling, with completion anticipated by mid-2027, which will significantly bolster the company's competitive edge in the cancer immunotherapy market.
- Enhanced Strategic Leadership: The appointment of Dr. Craig Tendler to oversee clinical development strategy and operations aims to leverage his extensive experience to advance the VISTA inhibiting antibody TBS-2025, thereby strengthening the company's R&D capabilities and market positioning.
See More
TuHURA Biosciences Appoints New CMO to Drive Oncology Strategy
- Executive Appointment: TuHURA Biosciences has appointed Dr. Craig L. Tendler as Chief Medical Officer (CMO), who will oversee clinical development strategy and operations, leveraging his 30 years of experience in oncology to advance the TBS-2025 program, which is expected to significantly enhance the company's competitiveness in blood-related cancer treatments.
- Regulatory Approval Achievements: Dr. Tendler has coordinated over 30 regulatory approvals and 15 new medical entity approvals in oncology, including four biologic or cell therapy approvals, generating over $16 billion in global sales, highlighting his substantial impact in the industry.
- Clinical Development Plans: TuHURA's TBS-2025 project has received preliminary feedback from the FDA, and Dr. Tendler will utilize his extensive experience in NPM1 mutated acute myeloid leukemia (AML) to accelerate the clinical development of this drug, aiming to improve overall survival rates for patients.
- Strategic Collaboration and Investment: Dr. Tendler's successful tenure at Johnson & Johnson, including collaborations with the FDA and EMA to secure global approvals for transformative therapies, will provide invaluable strategic guidance for TuHURA's future development, particularly in the complex landscape of oncology drug development.
See More
