LOS ANGELES - Aadi Bioscience, Inc. ('Aadi') (Nasdaq: AADI), a biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, announced the launch and commercial availability of its first proprietary product, FYARRO (sirolimus protein-bound particles for injectable suspension) (albumin-bound) for intravenous use for the treatment of adult patients with locally advanced unresectable or metastatic malignant PEComa. FYARRO was approved by the U.S. Food and Drug Administration (FDA) on November 22, 2021 and is the first treatment specific to this ultra-rare sarcoma. FYARRO was also recently added to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines) as the only preferred treatment regimen for malignant PEComa.

'All of us at Aadi are truly proud to be able to offer this treatment to patients living with malignant PEComa, who have had no FDA-approved treatment options specific to this ultra-rare cancer until now. We are thankful to all the patients, families, and caregivers whose participation in and support of the AMPECT trial ultimately made this advancement possible,' commented Neil Desai, Ph.D., Founder, President and Chief Executive Officer of Aadi. 'We consider the availability of FYARRO in this indication an important advancement towards building out a potential 'pipeline within a product' and look forward to studying FYARRO in other tumor types with alterations in mTOR pathway genes. Our PRECISION-1 study, a registrational trial of FYARRO in patients with solid tumors with pathogenic alterations in TSC1 or TSC2 genes, is now open for enrollment,' he added.

Aadi has also launched 'Aadi Assist' as its comprehensive patient support program. This program offers resources designed to connect patients with co-pay assistance, referrals, educational resources, verification of benefits and to ensure access to this important drug as quickly and efficiently as possible.

Brendan Delaney, Chief Operating Officer of Aadi Bioscience, commented, 'We have built a highly experienced commercial team and we are excited to launch Aadi's first product in the United States. We are committed to working with payers and healthcare providers across the country to help ensure access to FYARRO. We are also pleased that the NCCN Sarcoma panel quickly included FYARRO as the only preferred regimen for malignant PEComa. This recommendation will help oncologists to make informed treatment decisions and will also accelerate patient access to therapy across the United States.'

About NCCN

The NCCN is a not-for-profit alliance of 27 leading U.S. cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care. The intent of the NCCN Guidelines is to assist in the decision-making process of individuals involved in cancer care - including physicians, nurses, pharmacists, payers, patients, and their families - with the ultimate goal of improving patient care and outcomes. NCCN recommended guidelines are listed by cancer types and FYARRO can be found within the Soft Tissue Sarcoma section within 'Systemic Therapy Agents and Regimens with Activity in Soft Tissue Sarcoma Subtypes'.

About Malignant PEComa

Advanced malignant PEComa, defined by the World Health Organization as 'mesenchymal tumors composed of distinctive cells that show a focal association with blood-vessel walls and usually express both melanocytic and smooth muscle markers,' are a rare subset of soft-tissue sarcomas, with an undefined cell of origin. While there is no formal epidemiology for malignant PEComa, it is estimated that there are about 100-300 new patients per year in the United States. Malignant PEComas may arise in almost any body site (typically the uterus, retroperitoneum, lung, kidney, liver, genitourinary, and gastrointestinal tract with a female predominance) and can have an aggressive clinical course including distant metastases and ultimately death. The estimated prognosis based on retrospective reports is 12-16 months. Cytotoxic chemotherapies typically used for sarcoma show minimal benefit. Malignant PEComas have been shown to frequently harbor alterations in the TSC1 or TSC2 genes that result in the activation of mTOR pathway thus making mTOR a rational therapeutic target for this disease.

About FYARRO

FYARRO (sirolimus protein-bound particles for injectable suspension) (albumin-bound) is an mTOR inhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).

About Aadi Bioscience

Aadi is a commercial-stage biopharmaceutical company focused on precision therapies for genetically-defined cancers. Aadi's primary goal is to bring transformational therapies to cancer patients with mTOR pathway driver alterations 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. In November 2021, Aadi received FDA approval for FYARRO for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). FYARRO is 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.

Based on data from the AMPECT trial with FYARRO and following discussions with the FDA about other emerging data with FYARRO, Aadi has initiated PRECISION 1, a tumor-agnostic registrational trial in mTOR inhibitor-naive solid tumors harboring TSC1 or TSC2 inactivating alterations. Aadi also has ongoing studies to evaluate dosing of FYARRO in combination regimens. More information on Aadi's development pipeline is available on the Aadi website at www.aadibio.com.

Forward-Looking Statements

Aadi cautions you that certain statements included in this press release that are not a description of historical facts are forward-looking statements. These statements are based on Aadi's current beliefs and expectations. Forward-looking statements include statements regarding: our plans and potential for success relating to commercializing FYARRO, the expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of FYARRO, our plans related to further development and manufacturing of FYARRO, the timing of additional clinical trials, including the registrational trial in patients harboring TSC1 and TSC2 inactivating alterations, the timing or likelihood of regulatory filings and approvals of FYARRO, including in potential additional indications and potential filings in additional jurisdictions, anticipated reception of FYARRO in the physician community, and the sufficiency of our existing capital resources to fund our future operating expenses and capital expenditure requirements. Actual results could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: risks related to Aadi's ability to successfully commercialize; uncertainties associated with the clinical development and regulatory approval of FYARRO, including potential delays in the commencement, enrollment and completion of clinical trials for additional indications; the risk that interim results of clinical trials may not be reproduced and do not necessarily predict final results; the risk that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available; the risk that unforeseen adverse reactions or side effects may occur in the course of commercializing, developing and testing FYARRO; risks associated with the failure to realize any value from FYARRO in light of inherent risks and difficulties involved in successfully bringing product candidates to market; risks related to Aadi's estimates regarding future expenses, capital requirements and need for additional financing; and risks related to the impact of the COVID-19 outbreak on Aadi's operations, the biotechnology industry and the economy generally.

Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption 'Risk Factors' in Aadi's Form 10-Q filed on November 10, 2021, and elsewhere in Aadi's reports and other documents that Aadi has filed, or will file, with the SEC from time to time and available at www.sec.gov.

All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Aadi undertakes no obligation to revise or update any forward-looking statement, 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 caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

FYARRO is a trademark of Aadi Bioscience, Inc.

For more information about FYARRO, visit: https://fyarro.com/

For more information about Aadi Assist, go to: http://aadiassist.com/.

For more information about the National Comprehensive Cancer Network, go to: https://www.nccn.org/home/about

Contact:

Investors

Irina Koffler

LifeSci Advisors LLC

E: ikoffler@lifesciadvisors.com

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