Whitehawk Therapeutics, Inc. Q2 FY2024 earnings call

• Aadi focuses on combining nab technology and sirolimus for mTOR inhibition, with FYARRO having achieved $51.1M in sales since launch for advanced malignant PEComa.
• PRECISION1, a registration-intended tumor-agnostic trial, is fully enrolled and expected to complete by year-end, with a Q3 2024 interim readout including 80 patients and evaluation of overall response rate. Early interim data from PRECISION1 showed sustained tumor reductions in heavily pretreated populations.
• EEC and NET trials are enrolling well, with initial data expected later in 2024. The EEC trial has completed the first cohort and is in the second, while the NET trial is also accruing rapidly.
• TSC1 and TSC2 mutations define a large oncology population with a projected U.S. market opportunity of $300M to $600M for nab-sirolimus in late-line settings.

FYARRO product sales were $6.2 million for the second quarter, in line with the prior year period and up 15% over Q1. Cumulative sales since launch in February 2022 amount to $51.1 million. FYARRO saw a 14% increase in the number of ordering accounts compared to Q1, with growth across all segments.

• PRECISION1 Q3 interim readout expected in 2024, with potential for data-driven discussion with FDA on submission path. Full results of PRECISION1 expected in 2025, with potential filing in 2025 if data holds.
• FYARRO expected to continue incremental growth, with Q2 showing strong rebound in demand across segments.
• Confidence in the design of PRECISION1 as a tumor-agnostic trial and bullish on commercial potential beyond PEComa.

Statements made include forward-looking statements, and actual events or results could differ materially due to various risks, uncertainties, and factors set forth in the risk factors section of annual and quarterly filings with the SEC.

Q: Roger Song asks about PRECISION1 second interim data, expectations, and FDA discussion.

A: David Lennon states the Q3 readout will present primary endpoint analysis on 80 patients, with discussion with FDA on potential submission path. Loretta Itri adds no additional comments.

Q: Joseph Catanzaro asks about PRECISION1 trial adjustments and FYARRO growth.

A: David Lennon says PRECISION1 is fully enrolled, no immediate adjustments expected, and FYARRO saw strong rebound in Q2 with continued growth expected.

Q: Ahu Demir asks about disclosing data on lines of treatment and endometrial trial demographics.

A: David Lennon says response rate overall will be disclosed, and Loretta Itri discusses the EEC trial design based on prior GOG study, noting PFS for letrozole Everolimus combination was 28 months.

Q: Dan asks about drug combinations, interim analysis timing, and PEComa sales.

A: David Lennon mentions exploring combinations, interim analysis in later Q3, and Loretta Itri discusses overall survival and NET trial expectations