TuHURA Biosciences (HURA) Q1 2025 earnings summary

Executive summary

• Clinical-stage immuno-oncology company advancing IFx-Hu2.0, with Phase 1b/2a trial initiated in MCCUP and Phase 3 trial in advanced/metastatic MCC planned for Q2 2025 under SPA with FDA.

• Completed reverse merger with Kintara Therapeutics in October 2024, resulting in a 1-for-35 reverse stock split and name change to TuHURA Biosciences.

• Entered into a merger agreement with Kineta, Inc., targeting closure in Q2 2025, contingent on a $20 million financing event, with plans to initiate Phase 2 trial of Kineta's VISTA inhibitor mAb in NPM1-mutated AML in Q3 2025.

• Advancing pipeline with bi-specific ADCs and APCs targeting MDSCs and DOR programs, with clinical and preclinical data presented at AACR 2025.

• Appointed Dr. Bertrand Le Bourdonnec as EVP, Head of Drug Discovery, and Dr. Craig L. Tendler to Board of Directors.

Financial highlights

• Net loss for Q1 2025 was $6.7 million, compared to $4.8 million in Q1 2024, driven by increased R&D and G&A expenses.

• Research and development expenses rose to $4.6 million (from $3.6 million year-over-year), mainly due to higher personnel and facility costs.

• General and administrative expenses increased to $2.4 million (from $1.0 million year-over-year), reflecting higher stock compensation and merger-related costs.

• Cash and cash equivalents were $6.2 million as of March 31, 2025.

• Total shares outstanding as of March 31, 2025, were approximately 43.7 million.

Outlook and guidance

• Existing capital resources, including anticipated warrant exercise payments, are expected to fund operations into late Q4 2025.

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

• Anticipates FDA lifting partial clinical hold on IFx-Hu2.0 in Q2 2025, enabling Phase 3 trial initiation.

• Kineta merger expected to close in Q2 2025, subject to $20 million financing and other customary conditions.

• Plans to present additional non-clinical data on ADC and APC candidates at medical meetings in 2025.