GlobeNewswire Inc | Nov 9, 2021 08:00AM EST

November 09, 2021

LOS ANGELES, Nov. 09, 2021 (GLOBE NEWSWIRE) -- Aadi Bioscience, Inc. (Aadi), clinical-stage biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, today announced that management will be participating in the upcoming Jefferies London Healthcare Conference and the Piper Sandler Virtual Healthcare Conference.

Conference details can be found below.

Jefferies London Healthcare ConferenceFormat: Pre-recorded presentation and one-on-one investor meetingsPresentation accessible on demand starting: Thursday, November 18 3:00 am ET / 12:00 am PTWebcast link: https://wsw.com/webcast/jeff201/aadi/1795986

A live webcast of this presentation will also be accessible in the Events & Presentations section of the companys website at https://aadibio.com/. Replay will also be available at this link for 90 days.

Piper Sandler Virtual Healthcare ConferenceFormat: Pre-recorded presentation and one-on-one investor meetingsPresentation accessible on demand for conference registrants starting: Monday, November 22 10:00 am ET / 7:00 am PT

About Aadi Bioscience and FYARRO

Aadi is a clinical-stage biopharmaceutical company developing precision therapies for genetically-defined cancers. Aadis primary goal is to bring transformational therapies to cancer patients with mTOR pathway driver alterations such as alterations in TSC1 or TSC2 genes, where other mTOR inhibitors have not or cannot be effectively exploited due to problems of pharmacology, effective drug delivery, safety, or effective targeting to the disease site. Aadis lead product candidate is FYARRO (sirolimus albumin-bound nanoparticles for injectable suspension; nab-sirolimus; ABI-009), an mTOR inhibitor bound to human albumin that has demonstrated significantly higher tumor accumulation, greater mTOR target suppression, and increased tumor growth inhibition over other mTOR inhibitors in preclinical models.

Aadis registration trial of FYARRO in advanced malignant PEComa (the AMPECT trial) demonstrated meaningful clinical efficacy in malignant PEComa, a type of cancer with the highest known alteration rate of TSC1 or TSC2 genes. FYARRO has received Breakthrough Therapy, Fast-Track and Orphan Designations from the U.S. Food and Drug Administration (FDA). A rolling New Drug Application (NDA) submission was completed in May 2021 for this indication and the FDA accepted the NDA in July 2021 and granted Aadi Priority Review status with a Prescription Drug User Fee Act (PDUFA) target action date of November 26, 2021.

Based on the AMPECT trial and emerging data for FYARRO in other solid tumors with TSC1 or TSC2 inactivating alterations, and following discussions with the FDA, Aadi plans to initiate a tumor-agnostic registrational trial in mTOR inhibitor-nave solid tumors harboring TSC1 or TSC2 inactivating alterations by the end of 2021 or early 2022. Aadi also has ongoing studies to evaluate dosing of FYARRO in combination regimens. FYARRO is an investigational drug that has not been approved by the FDA for commercial distribution in the United States. More information is available on the Aadi website at www.aadibio.com.

Contacts

Investors:Irina Kofflerikoffler@lifesciadvisors.com