Press Release

Data further support clinical exploration of nab-sirolimus in combination with endocrine therapy for hormone-driven cancers, as is currently being investigated for patients with endometrioid-type endometrial cancer in a Phase 2 trial

Data highlight potential for synergy to enhance anti-cancer effects and overcome resistance in non-small cell lung cancer

LOS ANGELES, April 9, 2024 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a commercial-stage precision oncology company focused on developing and commercializing therapies for cancers with alterations in the mTOR pathway, today announced it will present new non-clinical data that highlight the combinability of nab-sirolimus and its potential for synergy to enhance anti-cancer effects and overcome resistance. These data will be presented during poster sessions at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, CA, taking place April 5-10, 2024.

Poster presentation details and abstract highlights include:

Title: "Evaluation of nab-sirolimus in combination with fulvestrant or PI3K pathway inhibitors to overcome resistance in breast cancer cell lines"
Presenting Author: Shihe Hou, PhD
Session Title: Reversal of Drug Resistance
Poster Number: Poster Section 25; Poster 6
Date/Time: Wednesday, April 10, 2024, 9:00 AM – 12:30 PM

• Fulvestrant, the selective estrogen receptor degrader and PI3K inhibitors, such as alpelisib, have demonstrated efficacy in patients with HR+ PI3K-mutated breast cancer; however, resistance still occurs
• nab-sirolimus enhanced the cytotoxic effects of fulvestrant in HR+ breast cancer cells and PI3Ki in both HR+ and HR- breast cancer cells
• The addition of nab-sirolimus to endocrine therapy or PI3K-AKT-mTOR pathway inhibitors may mutually overcome mechanisms of resistance induced by single-agent treatments
• These data further support the combination of nab-sirolimus with endocrine therapy for hormone-driven cancers, as is currently being investigated in patients with advanced or recurrent endometrioid endometrial cancer in a Phase 2 study (NCT05997017)

Title: "Correlation of nab-sirolimus tumor drug levels and improved tumor suppression in KRAS G12C non-small cell lung cancer xenografts treated with nab-sirolimus in combination with KRAS inhibitors"
Presenting Author: Shihe Hou, PhD
Session Title: Targeting Kinase and ERK Pathways
Poster Number: Poster Section 46; Poster 3
Date/Time: Tuesday, April 9, 1:30 – 5:00 PM

• Corresponding with greater antitumor activity, nab-sirolimus was associated with higher intratumoral drug concentration and stronger mTOR target suppression than everolimus when the agents were combined with KRAS G12C inhibitors
• These findings suggest more efficient tumor-targeting with nab-sirolimus plus a KRAS G12C inhibitor may lead to improved target inhibition and improved clinical outcomes

About Aadi Bioscience 
Aadi is a commercial-stage precision oncology company focused on the development and commercialization of therapies for cancers with alterations in the mTOR pathway, a key regulator of cell growth and cancer progression. To unlock the full potential of mTOR inhibition, Aadi uniquely combines nanoparticle albumin-bound (nab) technology with the potent mTOR inhibitor, sirolimus. Aadi received FDA approval and commercializes FYARRO® for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).

Aadi is exploring nab-sirolimus in PRECISION1, a Phase 2 tumor-agnostic registration-intended trial in mTOR inhibitor-naïve malignant solid tumors harboring TSC1 or TSC2 inactivating alterations. Aadi is also exploring nab-sirolimus in two single-indication Phase 2 trials for difficult-to-treat mTOR-driven cancers: neuroendocrine tumors (NETs), and advanced or recurrent endometrioid-type endometrial cancer (EEC) in combination with letrozole. More information on the Company's development pipeline is available on the Aadi website at www.aadibio.com and connect with us on Twitter and LinkedIn.

Forward-Looking Statements 
This press release contains certain forward-looking statements regarding the business of Aadi Bioscience that are not a description 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, but are not limited to, statements relating to: expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of FYARRO; expectations regarding the clinical responses and safety profile, regulatory approval and commercialization; and the sufficiency of the Company's existing capital resources and the expected timeframe to fund the Company's 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, those associated with the uncertainties associated with the clinical development and regulatory approval of FYARRO in additional indications; the risk that non-clinical results may not be reproduced and do not necessarily predict clinical results; the risk that unforeseen adverse reactions or side effects may occur in the course of commercializing, developing and testing FYARRO; and risks related to the Company's estimates regarding 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 contemplated by 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 caption "Item 1A. Risk Factors," 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 cautionary statement is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Contact:
IR@aadibio.com

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SOURCE Aadi Bioscience