READ THE FULL HURA RESEARCH REPORT
Operational and Financial Results
On November 14th, 2025, TuHURA Biosciences, Inc. (NASDAQ:HURA) reported third quarter 2025 financial and operational results and filed its Form 10-Q with the SEC. The company is conducting its IFx-2.0 Phase III trial in Merkel cell carcinoma (MCC), which is expected to read out in early 2027. It continues to advance Kineta’s VISTA asset, now designated TBS-2025, and start the Phase II trial in 1Q:26. Other announcements include planned participation at the American Society of Hematology (ASH) Annual Meeting taking place in Orlando, Florida. Below, we summarize TuHURA’s quarterly financial results.
TuHURA generated no revenues in 3Q:25 and expended $6.7 million on operational activities related to advancing IFx-2.0 and other programs, producing a net loss of ($7.1) million or ($0.14) per share. For the quarter ending September 30th, 2025, and versus the same prior year period:
- Research & development expense totaled $5.0 million, increasing 69% from $2.9 million due to greater expenses for the IFx-2.0 and TBS-2025 programs, preclinical research related to IFx-3.0 and myeloid derived suppressor cell (MDSC) initiatives, and higher salary, personnel, and facilities costs:
- General & administrative expense totaled $1.8 million, due to increases in non-cash stock compensation, merger transaction costs and expenses related to being a public company;
- Other items included $138,000 in grant income related to Kintara’s REM-001 asset and reimbursements from Health and Human Services and amounts related to share settlement to former Kineta employees;
- Net interest expense was $10,000;
- Net loss was ($7.1) million or ($0.14) per share.
As of September 30th, 2025, TuHURA held $2.7 million in cash on its balance sheet. Cash burn for the first nine months of 2025 was ($22.1) million, while net cash generated from financing sources was $13.4 million, which consisted of warrant proceeds and issuance of common stock partially offset by stock issuance costs and transaction and liability payments related to Kintara. In October, TuHURA entered into a $3.0 million loan agreement, of which $1.5 million of the loan was advanced upon execution. In November, TuHURA entered into an at-the-market (ATM) facility with HC Wainwright as its sales agent. A Form S-3 registration statement was filed to enable $50 million in capacity for the ATM. TuHURA also has $500,000 remaining on its final tranche offering, which is expected to be executed prior to year end 2025.
Phase III IFx-2.0 Trial in MCC
TuHURA launched its pivotal Phase III study for its IFx-2.0 candidate in Merkel cell carcinoma (MCC) in June. In the latest quarterly report, TuHURA set forth two related milestones for the study. Enrollment is expected to be complete in 4Q:26 and topline results are anticipated in 1Q:27.
IFx-2.0 will pursue a new drug application using the FDA’s accelerated approval program under a special protocol assessment (SPA). The trial was designed with the input of the FDA’s Oncology Center of Excellence (OCE). Accelerated approval allows the sponsor to use surrogate endpoints that predict clinical benefit. In most cases, an accelerated approval will require post-market confirmatory trials to verify the clinical benefit. However, in this case, the FDA has indicated that secondary endpoints that demonstrate clinical benefit may be used. If successfully achieved, the trial may satisfy the requirements for full approval.
Upcoming Milestones
Milestones
- IFx-2.0 trial launch – June 2025
- IFx-2.0 IR basket trial launch – May 2025
- Close of Kineta acquisition – June 2025
- IFx-3.0 CD22 tumor-targeted mRNA in vivo proof of concept studies – 2026
- Participation in the HC Wainwright Investment Conference – September 2025
- Appointment of Dr. Michael Turner as VP of Immunology – November 2025
- Form S-3 filed and agreement entered for ATM facility – November 2025
- Delta Opioid Receptor presentation at ASH – December 7th, 2025
- Enrollment progress update for IFx-2.0 – Year end 2025
- Launch VISTA inhibitor (TBS-2025) Phase II trial in NPM1 mutated AML – 1Q:26
- Selection of lead DOR inhibitor – 1Q:26
- IFx-2.0 Phase Ib/IIa preliminary results – 2Q:26
- TBS-2025 (VISTA) interim readout – mid-2026
- First proof of concept with in-vivo results for lead antibody drug conjugate (ADC) – 3Q:26
- IFx-2.0 Phase III topline results – 1Q:27
Company Pipeline
Summary
TuHURA reports 3Q:25 financial results with two active clinical trials on the IFx-2.0 platform and one to begin shortly for TBS-2025. Its ranks were augmented with the appointment of Dr. Michael Turner as VP of immunology in November. In December, the company will present its DOR technology at the ASH conference along with two other poster presentations. We expect to see a continuation of activity over the next several months as the IFx-2.0 studies enroll, preparations for the start of the Phase II TBS-2025 trial are completed and the trial is launched.
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