TuHURA Biosciences (HURA) Q3 2025 earnings summary

Executive summary

• Clinical-stage immuno-oncology company focused on overcoming resistance to cancer immunotherapies, with three core technology platforms: IFx, TBS-2025, and Delta Opioid Receptor modulators.

• Phase 3 accelerated approval trial of IFx-2.0 as adjunctive therapy with pembrolizumab for advanced/metastatic Merkel cell carcinoma (MCC) is underway under an SPA agreement with the FDA.

• Protocol design for Phase 2 study of TBS-2025 (VISTA-inhibiting antibody) in NPM1 mutated AML is being finalized, with FDA submission planned for Q4 2025 and trial initiation in Q1 2026.

• Delta Opioid Receptor (DOR) technology selected for oral and poster presentations at the ASH 2025 Annual Meeting, highlighting its potential as a novel immunotherapy target.

• Appointment of Dr. Michael Turner as Vice President of Immunology, bringing over 20 years of industry experience.

Financial highlights

• Net loss for Q3 2025 was $7.1 million, compared to $6.5 million in Q3 2024; net loss for nine months ended September 30, 2025 was $23.3 million, up from $16.7 million year-over-year.

• Research and development expenses rose to $5.0 million in Q3 2025 (from $2.9 million in Q3 2024) and $14.5 million for the nine months (from $9.4 million year-over-year).

• General and administrative expenses increased to $1.8 million in Q3 2025 (from $0.8 million) and $9.1 million for the nine months (from $2.6 million year-over-year).

• Cash and cash equivalents were $2.7 million as of September 30, 2025.

• Net cash outflows from operating activities were $22.1 million for the nine months ended September 30, 2025, compared to $12.1 million for the same period in 2024.

Outlook and guidance

• Existing capital resources, including anticipated final tranche from private placement and bridge loan, expected to fund operations through end of 2025.

• Substantial doubt remains about ability to continue as a going concern for the next 12 months without additional fundraising.

• Preliminary results from Phase 1b/2a trial of IFx-2.0 in MCCUP expected in Q2 2026.

• Completion of enrollment in Phase 3 IFx-2.0 trial anticipated in Q4 2026, with topline results in Q1 2027.

• Phase 2 protocol for TBS-2025 to be submitted to FDA in Q4 2025, with trial initiation in Q1 2026.