Whitehawk Therapeutics, Inc. Q4 FY2023 earnings call

• Aadi is focused on unlocking the full potential of mTOR inhibition by combining nab technology and sirolimus. FYARRO sales remained solid with $24.4 million cumulative for 2023, a 60% growth over prior year. - Clinically, PRECISION 1 trial had top line results from first 40 patients with sustained tumor reductions. PRECISION 1 is expected to be fully enrolled by May, with next interim readout in Q3 2024 and study completion by end of 2024. - There are ongoing trials for endometrial cancer and neuroendocrine tumors (NETs), both actively enrolling, with initial data expected later this year. - In 2023, cash at the end of the year was $108.8 million in cash, cash equivalents and short-term investments.

FYARRO net product sales for the fourth quarter were $6.3 million, representing a 21% growth over the prior year quarter. For the full year 2023, FYARRO achieved cumulative sales of $24.4 million, which is a 60% growth compared to the prior year's $15.2 million. Research and development expenses in the fourth quarter increased to $12.8 million from $9.4 million in the prior year quarter. Selling, general and administrative expenses in the fourth quarter were $10.3 million compared to $11.1 million in the same period of 2022. Net loss for the fourth quarter was $16.3 million compared to $13.9 million in the fourth quarter of 2022, and the full year net loss was $65.8 million compared to $60.5 million in the prior year.

• PRECISION 1 trial is expected to be fully enrolled by May, with next interim readout in Q3 2024 and study completion by end of 2024. - FYARRO continues to have sustained demand and is a valuable asset. - Clinical trials for endometrial cancer and NETs are expected to report initial data later this year.

• Statements made on the call include forward-looking statements, and actual events or results could differ materially due to various risks, uncertainties and other factors set forth in the Risk Factors section of annual and quarterly filings with the Securities and Exchange Commission.

Q: Joe Catanzaro asked about the remainder of the PRECISION 1 trial and enrollment dynamics since interim data disclosure.

A: Dave Lennon said the first 40 patients were heavily pretreated, the trial is still enrolling, and the next interim with 80 patients will be in Q3.

Q: Liang Cheng inquired about FYARRO's commercial plans and tumor agnostic label.

A: Scott Giacobello mentioned FYARRO sales stabilizing, and Loretta Itri stated FDA看重肿瘤类型的多样性、合理的缓解率和良好的安全概况。Q: Ahu Demir asked about sites open, inclusion/exclusion criteria for endometrial cancer trial and pretreated patients.

A: Loretta Itri said it's an open-label Phase II study for advanced endometrial cancer, patients with no or one prior line of chemotherapy, and early results expected later this year.