TuHURA Biosciences Files IND for TBS-2025 with FDA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 2 days ago
0mins
TuHURA Biosciences announced that it has filed an Investigational New Drug application with the U.S. FDA for the study of its TBS-2025 VISTA inhibiting antibody for the treatment of molecularly defined subsets of AML and other blood related cancers. The IND is being filed following detailed feedback and guidance from the FDA on the IND filed in February 2026. The company is targeting initiation of the Phase 1b/2 study in the second half of 2026.
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Current: 2.230
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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 Biosciences Files IND Application for TBS-2025 in AML
- IND Application Filed: TuHURA Biosciences has submitted an IND application to the FDA for TBS-2025, targeting acute myeloid leukemia (AML) and other blood-related cancers, marking a significant advancement in the field of cancer immunotherapy.
- FDA Feedback Incorporated: The FDA provided comprehensive feedback on trial design, which TuHURA has integrated into its proposed Phase 1b/2 trial, aiming to save 4-6 months in development time through a more efficient study design, thereby accelerating clinical progress.
- Clinical Trial Plans: The company is targeting to initiate the Phase 1b/2 study in the second half of 2026, focusing on evaluating the safety and potential efficacy of TBS-2025 in relapsed/refractory AML patients, particularly those with NPM1 mutations, addressing a significant treatment gap in this area.
- Addressing Market Needs: With no effective treatment options currently available for patients with relapsed/refractory high-risk myelodysplastic syndrome (MDS), the development of TBS-2025 aims to meet this substantial unmet medical need, potentially offering new hope for patients.
See More
TuHURA Biosciences Q1 2026 Financial Results
- Cash Position: As of March 31, 2026, TuHURA reported cash and cash equivalents of $6.3 million, and despite ongoing cash outflows, the company secured $7.2 million from financing activities, extending its cash runway to 2028.
- R&D Expenses: In Q1 2026, research and development expenses reached $5.2 million, up from $4.6 million in Q1 2025, indicating the company's commitment to investing in technology development to enhance future product competitiveness.
- Operating Expenses: General and administrative expenses for Q1 2026 were $2.3 million, an increase from $2.0 million in Q1 2025, reflecting higher operational management costs that may impact short-term profitability.
- Net Cash Outflows: The net cash outflow from operating activities for Q1 2026 was $4.4 million, an improvement from $4.7 million in Q1 2025, suggesting progress in the company's efforts to control operational costs.
See More
TuHURA Biosciences Reports Q1 Financial Highlights and Strategic Developments
- Funding Expansion: TuHURA established a $50 million credit facility with its largest stockholder, providing a non-equity source of operating capital that allows the company to fund operations ahead of anticipated top-line data in its IFx-2.0 program, enhancing financial flexibility.
- R&D Spending Overview: The company reported research and development expenses of $5.2 million for Q1 2026, up from $4.6 million in Q1 2025, reflecting ongoing investment in drug development aimed at accelerating product launch timelines.
- Cash Flow Analysis: As of March 31, 2026, TuHURA had $6.3 million in cash and cash equivalents, with net cash outflows from operating activities at $4.4 million; however, net cash inflows from financing activities were $7.2 million, indicating proactive financial management.
- Clinical Trial Progress: The company plans to meet with the FDA to discuss the IND and development plan for its VISTA inhibitor TBS-2025 and initiate a Phase 1b/2 trial for specific AML patients, marking a strategic advancement in its cancer immunotherapy initiatives.
See More
TuHURA Biosciences Reports Q1 Financial Results and Corporate Update
- Financing Progress: TuHURA established a $50 million credit facility with its largest stockholder, extending its cash runway into 2028, which enhances the company's financial flexibility for ongoing clinical development and supports the advancement of its IFx-2.0 program.
- Executive Appointments: Dr. Craig Tendler has been appointed as Chief Medical Officer to oversee clinical development strategy, while Amanda Garofalo has been appointed as Senior Vice President of Clinical Operations, both of whom will enhance the company's execution capabilities in clinical trials and accelerate drug development processes.
- FDA Orphan Drug Designation: IFx-2.0 received FDA Orphan Drug Designation based on its safety profile and clinical benefits observed in patients resistant to PD-1 therapy during Phase 1 studies, which is expected to lay the groundwork for future market promotion and clinical applications.
- Financial Performance: As of March 31, 2026, TuHURA reported cash and cash equivalents of $6.3 million, with research and development expenses of $5.2 million; despite a net cash outflow of $4.4 million, the $7.2 million cash inflow from financing activities reflects a proactive approach to financial management.
See More
TuHURA Biosciences to Participate in Investor Conference
- Investor Conference Participation: TuHURA Biosciences' CEO, Dr. James A. Bianco, will participate in a fireside chat at the H.C. Wainwright BioConnect Investor Conference on May 19, 2026, in New York City, showcasing the company's advancements in cancer immunotherapy to attract potential investors.
- Clinical Trial Progress: TuHURA is conducting a Phase 3 registration trial for IFx-2.0, administered as an adjunct therapy to Keytruda® for advanced or metastatic Merkel Cell Carcinoma, demonstrating potential to overcome resistance to immunotherapy and offering new treatment options for patients.
- Diverse Product Development: In addition to IFx-2.0, TuHURA is developing TBS-2025, a VISTA-inhibiting monoclonal antibody targeting a specific subgroup of AML patients, which is set to enter Phase 1b/2 trials, further enriching its product pipeline to address various cancer types.
- Innovative Technology Application: TuHURA is leveraging its Delta Opioid Receptor technology to develop first-in-class bispecific antibody-drug conjugates aimed at inhibiting immune-suppressive cells in the tumor microenvironment, preventing T cell exhaustion and acquired resistance to immunotherapy, highlighting its strategic potential in cancer treatment.
See More
TuHURA Biosciences Secures $50 Million Loan for Clinical Pipeline
- Loan Agreement Established: TuHURA Biosciences has entered into a loan agreement with its largest shareholder, K&V Investment One LLC, providing up to $50 million in funding aimed at supporting its clinical pipeline and operations.
- Loan Terms: The facility carries a 12% annual interest rate, with interest payable monthly and principal due at maturity in April 2031, secured by the company's assets to ensure financial safety.
- Clear Funding Purpose: TuHURA stated that the financing will fund late-stage trials for IFx-2.0 and progress on TBS-2025, extending the company's cash runway into 2028, thereby enhancing its market competitiveness.
- Royalty Grant: As part of the agreement, TuHURA granted the lender a low- to mid-single digit royalty on annual sales of products based on its lead candidate, IFx-2.0, further increasing the attractiveness of the financing.
See More
TuHURA Biosciences Files IND Application for TBS-2025 in AML
- IND Application Filed: TuHURA Biosciences has submitted an IND application to the FDA for TBS-2025, targeting acute myeloid leukemia (AML) and other blood-related cancers, marking a significant advancement in the field of cancer immunotherapy.
- FDA Feedback Incorporated: The FDA provided comprehensive feedback on trial design, which TuHURA has integrated into its proposed Phase 1b/2 trial, aiming to save 4-6 months in development time through a more efficient study design, thereby accelerating clinical progress.
- Clinical Trial Plans: The company is targeting to initiate the Phase 1b/2 study in the second half of 2026, focusing on evaluating the safety and potential efficacy of TBS-2025 in relapsed/refractory AML patients, particularly those with NPM1 mutations, addressing a significant treatment gap in this area.
- Addressing Market Needs: With no effective treatment options currently available for patients with relapsed/refractory high-risk myelodysplastic syndrome (MDS), the development of TBS-2025 aims to meet this substantial unmet medical need, potentially offering new hope for patients.
See More
TuHURA Biosciences Q1 2026 Financial Results
- Cash Position: As of March 31, 2026, TuHURA reported cash and cash equivalents of $6.3 million, and despite ongoing cash outflows, the company secured $7.2 million from financing activities, extending its cash runway to 2028.
- R&D Expenses: In Q1 2026, research and development expenses reached $5.2 million, up from $4.6 million in Q1 2025, indicating the company's commitment to investing in technology development to enhance future product competitiveness.
- Operating Expenses: General and administrative expenses for Q1 2026 were $2.3 million, an increase from $2.0 million in Q1 2025, reflecting higher operational management costs that may impact short-term profitability.
- Net Cash Outflows: The net cash outflow from operating activities for Q1 2026 was $4.4 million, an improvement from $4.7 million in Q1 2025, suggesting progress in the company's efforts to control operational costs.
See More
TuHURA Biosciences Reports Q1 Financial Highlights and Strategic Developments
- Funding Expansion: TuHURA established a $50 million credit facility with its largest stockholder, providing a non-equity source of operating capital that allows the company to fund operations ahead of anticipated top-line data in its IFx-2.0 program, enhancing financial flexibility.
- R&D Spending Overview: The company reported research and development expenses of $5.2 million for Q1 2026, up from $4.6 million in Q1 2025, reflecting ongoing investment in drug development aimed at accelerating product launch timelines.
- Cash Flow Analysis: As of March 31, 2026, TuHURA had $6.3 million in cash and cash equivalents, with net cash outflows from operating activities at $4.4 million; however, net cash inflows from financing activities were $7.2 million, indicating proactive financial management.
- Clinical Trial Progress: The company plans to meet with the FDA to discuss the IND and development plan for its VISTA inhibitor TBS-2025 and initiate a Phase 1b/2 trial for specific AML patients, marking a strategic advancement in its cancer immunotherapy initiatives.
See More
TuHURA Biosciences Reports Q1 Financial Results and Corporate Update
- Financing Progress: TuHURA established a $50 million credit facility with its largest stockholder, extending its cash runway into 2028, which enhances the company's financial flexibility for ongoing clinical development and supports the advancement of its IFx-2.0 program.
- Executive Appointments: Dr. Craig Tendler has been appointed as Chief Medical Officer to oversee clinical development strategy, while Amanda Garofalo has been appointed as Senior Vice President of Clinical Operations, both of whom will enhance the company's execution capabilities in clinical trials and accelerate drug development processes.
- FDA Orphan Drug Designation: IFx-2.0 received FDA Orphan Drug Designation based on its safety profile and clinical benefits observed in patients resistant to PD-1 therapy during Phase 1 studies, which is expected to lay the groundwork for future market promotion and clinical applications.
- Financial Performance: As of March 31, 2026, TuHURA reported cash and cash equivalents of $6.3 million, with research and development expenses of $5.2 million; despite a net cash outflow of $4.4 million, the $7.2 million cash inflow from financing activities reflects a proactive approach to financial management.
See More
TuHURA Biosciences to Participate in Investor Conference
- Investor Conference Participation: TuHURA Biosciences' CEO, Dr. James A. Bianco, will participate in a fireside chat at the H.C. Wainwright BioConnect Investor Conference on May 19, 2026, in New York City, showcasing the company's advancements in cancer immunotherapy to attract potential investors.
- Clinical Trial Progress: TuHURA is conducting a Phase 3 registration trial for IFx-2.0, administered as an adjunct therapy to Keytruda® for advanced or metastatic Merkel Cell Carcinoma, demonstrating potential to overcome resistance to immunotherapy and offering new treatment options for patients.
- Diverse Product Development: In addition to IFx-2.0, TuHURA is developing TBS-2025, a VISTA-inhibiting monoclonal antibody targeting a specific subgroup of AML patients, which is set to enter Phase 1b/2 trials, further enriching its product pipeline to address various cancer types.
- Innovative Technology Application: TuHURA is leveraging its Delta Opioid Receptor technology to develop first-in-class bispecific antibody-drug conjugates aimed at inhibiting immune-suppressive cells in the tumor microenvironment, preventing T cell exhaustion and acquired resistance to immunotherapy, highlighting its strategic potential in cancer treatment.
See More
TuHURA Biosciences Secures $50 Million Loan for Clinical Pipeline
- Loan Agreement Established: TuHURA Biosciences has entered into a loan agreement with its largest shareholder, K&V Investment One LLC, providing up to $50 million in funding aimed at supporting its clinical pipeline and operations.
- Loan Terms: The facility carries a 12% annual interest rate, with interest payable monthly and principal due at maturity in April 2031, secured by the company's assets to ensure financial safety.
- Clear Funding Purpose: TuHURA stated that the financing will fund late-stage trials for IFx-2.0 and progress on TBS-2025, extending the company's cash runway into 2028, thereby enhancing its market competitiveness.
- Royalty Grant: As part of the agreement, TuHURA granted the lender a low- to mid-single digit royalty on annual sales of products based on its lead candidate, IFx-2.0, further increasing the attractiveness of the financing.
See More
