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Aadi Bioscience Announces Financial Results and Operational Update for the First Quarter 2023 and Provides Update on PRECISION 1 Tumor Agnostic Trial

Total 1Q 2023 revenue on FYARRO® sales of $5.9 million PRECISION 1 tumor agnostic trial enrolling equally in TSC1 and TSC2 arms with more than 15 discreet

articleWhitehawk Therapeutics, Inc.May 10, 20234/company/whitehawk-therapeutics-inc/news/aadi-bioscience-announces-financial-results-and-operational-update-for-the-first-quarter-2023-and-provides-update-on-precision-1-tumor-agnostic-trial
Aadi Bioscience Announces Financial Results and Operational Update for the First Quarter 2023 and Provides Update on PRECISION 1 Tumor Agnostic Trial

About this update from Whitehawk Therapeutics, Inc.

[{"type":"text","content":"Total 1Q 2023 revenue on FYARRO® sales of $5.9 million \nPRECISION 1 tumor agnostic trial enrolling equally in TSC1 and TSC2 arms with more than 15 discreet tumor types represented\nInterim analysis on 40 patients with appropriate follow-up in PRECISION 1 trial expected by end of 2023\nConference call to be held today at 8:30 am EDT\nLOS ANGELES, May 10, 2023 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for genetically defined cancers with alterations in mTOR pathway genes, today announced financial results for the first quarter of 2023 and provided an initial update on the tumor-agnostic PRECISION 1 trial, a registration-directed Phase 2 study of nab-sirolimus in patients with solid tumors with pathogenic inactivating alterations in TSC1 or TSC2 genes.\n\"We are excited about the uptake of FYARRO and its continued sales growth after our first year on the market and believe we are operating from a position of strength with solid cash balances into 2025,\" said Scott Giacobello, Interim CEO and President and CFO of Aadi. \"We are also encouraged by initial PRECISION 1 enrollment data, indicating more than 15 different tumor types on study, shaping the foundation for a truly tumor agnostic trial. We believe in the potential of this study and given the importance of maintaining its integrity, we will provide the results of an efficacy analysis later in the year when response data is unblinded in conjunction with a pre-planned interim analysis on 40 patients with appropriate follow-up.\"\nFirst Quarter 2023 Updates and Recent Operational Highlights \nBased on initial information from the PRECISION 1 trial, enrollment is well-balanced, and the trial is accruing evenly between the TSC1 and TSC2 arms. More than 15 discreet tumor types have been enrolled with no more than three of any type, supporting the thesis that TSC1 and TSC2 alterations occur broadly across different solid tumors. A pre-planned interim analysis on 40 patients with appropriate follow-up is expected by the end of 2023.FYARRO net product sales were $5.9 million in the first quarter, continued double-digit growth of 12% quarter-over-quarter.The appointment of Mohammad Hirmand, M.D., to Board of Directors. Dr. Hirmand, previously Chief Medical Officer of Turning Point The...

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