Aadi Bioscience provides PRECISION1 study and corporate updates

The tumor-agnostic PRECISION1 study is not expected to meet the regulatory requirements for accelerated approval and will be stopped

Aadi will focus on FYARRO^® commercial business for its approved indication, PEComa, and conduct a comprehensive strategic review to maximize shareholder value

To further secure liquidity, Aadi will adjust the ongoing Phase 2 studies and reduce the number of R&D employees by 80%thereby extending the cash runway at least until the second half of 2026

LOS ANGELES, 20 August 2024 /PRNewswire/ — Aadi Bioscience, Inc. (NASDAQ: AADI) today announced that it has initiated the PRECISION1 study for registration in grab-Sirolimus in patients with solid tumors TSC1 or TSC2 inactivating changes. An analysis by the Independent Data Monitoring Committee showed that the study was unlikely to cross the efficacy threshold required for accelerated approval, the primary goal of this Phase 2 study. The approximately 25 patients in PRECISION1, who are still receiving grab-Sirolimus may be switched to a planned expanded access protocol. A full analysis of the PRECISION1 study will be provided at a later date.

Aadi will now focus on preserving cash while maximizing his commercial business. Aadi's marketed product, FYARRO^®is the only preferred treatment for patients with advanced malignant PEComa, a rare and aggressive cancer. In the second quarter of this year, FYARRO achieved sales of 6.2 million USD.

To preserve its cash reserves, Aadi will pause the enrollment of new patients but continue treatment of patients already enrolled in two ongoing Phase 2 trials with grab-Sirolimus for advanced or recurrent endometrial cancer (EEC) and neuroendocrine tumors (NET). Both studies have enrolled sufficient patients (n=20 and n=10 for EEC and NET, respectively) to evaluate initial efficacy signals later this year. As part of these pipeline adjustments, the company is reducing its research and development workforce by 80%Together, these measures extend liquidity reserves until at least the second half of 2026.

“We are impressed by the achievements of the researchers, support staff and, most importantly, the patients and their families who participated in PRECISION1. grab-Sirolimus demonstrated monotherapy activity in the population studied, but the study did not provide what we believe would be required to support accelerated approval in the broader TSC1/TSC2 indication for inactivating mutations. We look forward to providing the full study analysis at a later date,” said David Lennon, President and CEO of Aadi Bioscience. “I would like to thank the dedicated Aadi employees who worked tirelessly on this study and are negatively impacted by this outcome. Given the change in the development pipeline, we have taken the necessary steps to immediately secure liquidity and have engaged a consulting firm to evaluate all options to maximize value for shareholders.”

About Aadi Bioscience

Aadi is a precision oncology company focused on commercializing FYARRO® for the treatment of adult patients with locally advanced, unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). For more information about the company, visit the Aadi website at www.aadibio.com. You can also reach us on Twitter and LinkedIn.

Forward-looking statements

This press release contains certain forward-looking statements regarding Aadi Bioscience's business that are not descriptions of historical facts within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on the Company's current beliefs and expectations and may include, among other things, statements with respect to: the Company's cash reserve extending into the second half of 2026; the Company's strategic review; the Company's workforce reductions; the anticipated timing of the release of the Company's clinical trial data, including the analysis of the PRECISION1 trial and initial efficacy signals from the EEC and NETS trials; and the adequacy of the Company's existing capital resources and the anticipated timeframe to fund the Company's future operating and capital expenditures. As a result of these risks and uncertainties, actual results may differ materially from those anticipated in such forward-looking statements. These risks and uncertainties include, among others, risks related to the ability to successfully commercialize FYARRO; the risk that unanticipated adverse reactions or side effects may occur during the course of commercialization, development and testing of FYARRO; uncertainties related to the clinical development and regulatory approval of FYARRO for additional indications; the inability to demonstrate the efficacy of FYARRO in clinical trials for additional indications; and risks related to the Company's estimates of future expenses, capital requirements and need for additional financing.

Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those anticipated in the forward-looking statements are included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including under the heading “Item 1A. Risk Factors,” and in Aadi's subsequent Quarterly Reports on Form 10-Q and elsewhere in Aadi's reports and other documents that Aadi has filed or will file from time to time with the SEC, which are available at www.sec.gov.

All forward-looking statements in this press release speak only as of the date hereof and, except as required by law, Aadi undertakes no obligation to revise or update any forward-looking statements or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This cautionary statement is provided pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

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(PRNewsphoto/Aadi Bioscience)