TuHURA Biosciences (HURA) Q2 2025 earnings summary

Executive summary

• Completed the acquisition of Kineta, Inc. on June 30, 2025, integrating its VISTA-inhibiting antibody TBS-2025 and personnel, and expanding the late-stage immuno-oncology pipeline.

• Initiated a Phase 3 trial for IFx-2.0 in advanced/metastatic Merkel cell carcinoma (MCC) and a Phase 1b/2a trial for MCC of unknown primary origin (MCCUP), under an SPA agreement with the FDA.

• Advanced preclinical work on IFx-3.0 and MDSC-targeting therapies, and planned Phase 2 development for TBS-2025 in NPM1-mutated AML.

• Raised $8.9 million in a private placement in June 2025, with an additional $3.7 million expected by year-end, and completed a $12.5 million equity financing plus $3 million from warrant exercises.

• Included in the Russell 3000 and Russell 2000 Indexes as of June 27, 2025, enhancing visibility and investor base.

Financial highlights

• Net loss was $9.5 million for Q2 2025, compared to $5.3 million in Q2 2024; net loss for the first half of 2025 was $16.2 million, up from $10.1 million in the prior year period.

• Research and development expenses rose to $4.9 million in Q2 2025 from $2.8 million in Q2 2024, driven by clinical and preclinical program expansion and higher personnel costs.

• General and administrative expenses increased to $4.9 million in Q2 2025 from $0.8 million in Q2 2024, mainly due to stock compensation, merger costs, and public company expenses.

• Cash and cash equivalents were $8.5 million as of June 30, 2025, with negative operating cash flow of $10.9 million for the first half of 2025.

• Accumulated deficit reached $127.3 million as of June 30, 2025.

Outlook and guidance

• Current cash resources, including anticipated private placement proceeds, are expected to fund operations into late Q4 2025.

• Plans to initiate a Phase 2 trial of TBS-2025 in combination with a menin inhibitor for relapsed/refractory NPM1-mutated AML in 2H 2025.

• Anticipates providing an update on Phase 3 IFx-2.0 trial enrollment by year-end 2025 and topline results from the Phase 1b/2a MCCUP trial in Q1 2026.

• Expects topline results from the Phase 3 IFx-2.0 trial in 2H 2026.

• Management expects continued operating losses and negative cash flows as clinical and preclinical programs advance, requiring substantial additional funding.