Whitehawk Therapeutics, Inc. Q1 FY2024 earnings call

• The PRECISION1 trial is fully enrolled across various tumor types with TSC1/TSC2 inactivating alterations. Interim results showed a 26% investigator-assessed overall response rate in the TSC1 arm. Next interim readout expected in Q3 2024.
• Phase II trials for endometrial cancer (EEC) and neuroendocrine tumors (NETs) are enrolling well; initial Part 1 data from these open label studies expected by end of 2024.
• Terminated collaboration with BMS to prioritize evaluation of nab-sirolimus in ongoing Phase II trials for EEC and NETs.

FYARRO had net product sales of $5.4 million in the first quarter of 2024, a decrease from prior year due to Q1 changes in distributor ordering patterns and fewer new commercial patient initiations. FYARRO is the preferred treatment for malignant PEComa, with high penetration in academic and community settings and over 200 accounts ordering since launch.

• PRECISION1 trial to have next interim readout in Q3 2024.
• Initial data from EEC and NET Phase II trials expected by end of 2024.
• Expect FYARRO sales to return to growth in Q2 2024.

• Uncertainties in clinical trial outcomes and their alignment with expectations.
• Risks that actual events or results may differ materially from forward-looking statements as per SEC filings.

Q: Roger Song asks about the expectation into the initial data readout later this year for the EEC and NET trials, including patient numbers and efficacy vs safety.

A: Dave Lennon and Loretta Itri respond that the EEC and NET trials are two-part Phase II studies with initial Part 1s enrolling ~10 patients each, and early efficacy and safety data are anticipated by the end of 2024, with recruitment going well.

Q: Joe Catanzaro asks about FYARRO cannibalization and the impact of PRECISION data.

A: Dave Lennon explains that there's a correlation between PRECISION sites and FYARRO commercial business swings, noting it's not PEComa patients in the trial as they're excluded, and it's a small number of patients causing the Q1 swing.

Q: Tara Bancroft asks about cost savings from terminating the Mirati collaboration.

A: Scott Giacobello states that specific information on savings from the terminated collaboration hasn't been shared yet.

Q: Ahu Demir asks about EEC program benchmarks and future plans with Mirati collaboration clinical data.

A: Loretta Itri talks about the EEC trial's Simon's 2-stage design with a response rate expectation exceeding 20%, and Dave Lennon says there are no current plans to expand into the RAS-mutated cancer area from the Mirati collaboration