TuHURA Biosciences (HURA) Q4 2024 earnings summary

Executive summary

• Achieved NASDAQ listing via reverse merger and raised $36 million to fund operations through late Q4 2025.

• Entered into a definitive agreement to acquire Kineta's Phase 2-ready VISTA inhibitor, with transaction targeted for Q2 2025.

• Preparing to initiate a Phase 3 accelerated approval trial for IFx-2.0 as adjunctive therapy with Keytruda in advanced Merkel cell carcinoma (MCC) in Q2 2025.

• Expanded discovery team to advance first-in-class immune modulating Antibody Drug or Peptide Conjugate Program.

Financial highlights

• Research and development expense increased to $13.3 million in 2024 from $9.4 million in 2023, mainly due to clinical development, preclinical research, and personnel costs.

• General and administrative expenses rose to $4.3 million in 2024 from $4.1 million in 2023, primarily due to stock compensation and public company costs.

Outlook and guidance

• Phase 3 IFx-2.0 trial enrollment planned for Q2 2025, with a key secondary endpoint (PFS) that may satisfy post-approval confirmatory requirements.

• Kineta acquisition expected to close in Q2 2025, with plans to advance VISTA inhibitor into Phase 2 trial in AML.

• Advancing delta opioid receptor technology platform and planning presentations at key scientific meetings.