TUHURA Biosciences Secures $15.5M Funding as IFx-2.0 Phase 3 Trial Launches

TUHURA Biosciences Inc.: Phase 3 Immuno-Oncology Pipeline Advances Amid Financing Initiatives

TUHURA Biosciences Inc. (NASDAQ: HURA) is a Phase 3 immuno-oncology company developing three technology platforms aimed at overcoming primary and acquired resistance to cancer immunotherapies. Its lead candidate, IFx-2.0, is currently being evaluated as an adjunct to Keytruda® (pembrolizumab) for the treatment of Merkel cell carcinoma, alongside a VISTA-inhibiting antibody (TBS-2025) and Delta Opioid Receptor–based tumor microenvironment modulators in its broader pipeline.

Corporate Structure and Leadership

TUHURA has assembled an executive team with substantial experience in the biotechnology sector:

• James Bianco, M.D., President & Chief Executive Officer
  • Over 30 years of experience in the biopharmaceutical industry; founded CTI Biopharma in 1991.
  • Oversaw the acquisition of pacritinib and the PERSIST-2 Phase 3 trial under the FDA accelerated approval pathway.

• Dan Dearborn, CPA, Chief Financial Officer
  • Background in finance with over 25 years of experience in healthcare and biotechnology.
  • Served in leadership roles at MYMD Pharmaceuticals and Welldyne, Inc.; held director positions at PharMerica.

• Dr. Bertrand Le Bourdonnec, Executive Vice President, Head of Drug Discovery, Early Development, and Program Management
  • Extensive R&D leadership experience across oncology and other therapeutic areas.
  • Held roles as CSO at HDAX Therapeutics and Vice President at Deciphera Pharmaceuticals.

(The total headcount is proprietary. The leadership team's experience reflects a depth of expertise relevant to oncology drug development.)

Immuno-Oncology by National Cancer Institute

Recent Developments and News

• June 3, 2025
  TUHURA completed a private placement raising $12.5 million of common stock and warrants, alongside an additional $3.0 million from warrant exercises. The proceeds will support the initiation of the IFx-2.0 Phase 3 trial and the merger with Kineta for the acquisition of TBS-2025.

• June 2025
  The company initiated a randomized, placebo-controlled Phase 3 study evaluating IFx-2.0 plus pembrolizumab for the treatment of advanced or metastatic Merkel cell carcinoma, operating under an FDA Special Protocol Assessment.

• September 30, 2025
  TUHURA's third quarter results were reported, with ongoing enrollment for the pivotal IFx-2.0 trial and progress on the protocol design for a Phase 2 study of TBS-2025 in NPM1-mutated acute myeloid leukemia.

• November 2025
  • Filed a registration statement for a $50 million At-The-Market (ATM) facility under Form S-3.
  • Announced the appointment of Michael Turner, Ph.D., as Vice President of Immunology.

• December 6–9, 2025
  TUHURA will have one oral and two poster presentations at the 67th ASH Annual Meeting in Orlando, focusing on Delta Opioid Receptor targeting of myeloid-derived suppressor cells.

Financial and Strategic Analysis

Metric	Figure
Share Price (as of 2025-12-09)	$1.2083
2025 YTD Price Change	-38.97%
Daily Volume	771,779 shares
Exchange	NASDAQ (HURA)

• Capital Raises: $12.5 million from a private placement (June 3, 2025); ATM facility capable of raising up to $50 million (November 2025).
• Use of Proceeds: Funding for the advancement of IFx-2.0 Phase 3 trials, the initiation of TBS-2025 Phase 2 studies, and ongoing development of Delta Opioid Receptor-based antibody-drug conjugates and antibody-peptide conjugates, as well as working capital.
• Strategic Focus:
  1. Development of the IFx platform aimed at innate immune activation.
  2. Exploration of the VISTA inhibitor TBS-2025 for myeloid-mediated immunosuppression in AML.
  3. Creation of Delta Opioid Receptor antibody-drug conjugates and antibody-peptide conjugates to modulate the tumor microenvironment and address resistance.

Market Position and Industry Context

TUHURA is positioned within the immuno-oncology market, competing with established checkpoint inhibitors such as pembrolizumab and nivolumab. The Phase 3 trial of IFx-2.0 addresses a rare and aggressive form of cancer with limited treatment options. Additionally, the planned Phase 2 trial for TBS-2025 in NPM1-mutated AML targets a population known for low treatment response and high relapse rates. The dual strategy to engage innate immunity, inhibit VISTA, and reprogram suppressive myeloid cells positions the company among emerging biotech firms seeking to improve the efficacy of current immunotherapies.

tl;dr

• Phase 3 trial for IFx-2.0 in Merkel cell carcinoma initiated June 2025 under FDA SPA.
• Completed a $12.5 million private placement on June 3, 2025; raised an additional $3.0 million from warrant exercises; filed $50 million ATM facility in November 2025.
• Scheduled for one oral and two poster presentations at ASH 2025 on December 7, 2025.
• Upcoming milestones include Q2 2026 preliminary data for IFx-2.0, Q4 2026 completion of Phase 3 enrollment, and Q1 2027 topline results.
• Shares traded at $1.2083, reflecting a year-to-date decline of 38.97% as of December 9, 2025.