On May 10, 2023 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, reported 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 (Press release, Aadi Bioscience, MAY 10, 2023, View Source [SID1234631415]).

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"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."

First Quarter 2023 Updates and Recent Operational Highlights

Based 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 Therapeutics prior to its acquisition by BMS, is the co-founder of Avenzo Therapeutics, Inc., and serves as executive vice president and chief medical officer of this privately held biotechnology company focused on oncology therapeutics.
Multiple presentations at AACR (Free AACR Whitepaper) Annual Meeting 2023. Aadi presented an encore trials-in-progress (TIP) poster for the ongoing PRECISION 1 trial; results on the anti-tumor activity of nab-sirolimus in combination with KRASG12C inhibitors in xenograft models; and results of a biomarker analysis from AMPECT correlating response to nab-sirolimus with TSC1 and TSC2 inactivating alterations. The AACR (Free AACR Whitepaper) posters can be found here on the Aadi website.
Multiple presentations at SGO Annual Meeting 2023. Aadi presented a TIP poster for the ongoing PRECISION 1 trial and additional data with nab-sirolimus from its AMPECT trial at SGO 2023. The SGO posters can be found here on the Aadi website.
Upcoming presentations at ASCO (Free ASCO Whitepaper) Annual Meeting 2023. Aadi will present a company-sponsored TIP update from the PRECISION 1 Phase 2 study and combination data of nab-sirolimus and pazopanib (PAZO) from an ongoing Investigator Initiated Trial at ASCO (Free ASCO Whitepaper) 2023, taking place June 2-6, 2023, in Chicago. Following Aadi’s presentation at ASCO (Free ASCO Whitepaper), the posters will be made available on the investor relations page of the Aadi website at www.aadibio.com.
Initiation of Phase 1/2 trial in KRASG12C is expected to begin with first patient dosing in the second quarter of 2023. The study will evaluate the combination of adagrasib with nab-sirolimus in collaboration with Mirati Therapeutics. The open-label Phase 1/2 trial is intended to determine the optimal dose and recommended Phase 2 dose in patients with KRASG12C mutant solid tumors.
First Quarter 2023 Financial Results

Total revenue resulting from sales of FYARRO for the quarter ended March 31, 2023 was $5.9 million. This compares to the prior year period of $2.3 million and $5.2 million in the fourth quarter 2022.
Cash, cash equivalents and short-term investments as of March 31, 2023 were $151.2 million as compared to $172.6 million as of December 31, 2022, which is expected to fund operations into 2025 based on current plans.
Net loss for the three months ended March 31, 2023 was $15.2 million as compared to $13.9 million for the three months ended March 31, 2022.
Conference Call Information

The Aadi management team is hosting a conference call and webcast today at 8:30 am ET (5:30 am PT) to provide a corporate update and discuss results for the first quarter 2023.

Participants may access a live webcast of the call on the "Investors & News" page of the Aadi Bioscience website at aadibio.com. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.

About FYARRO

FYARRO is an mTOR inhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).

About the PRECISION 1 Trial

The PRECISION 1 trial is a multi-center, open-label, tumor-agnostic registrational clinical trial of nab-sirolimus. This tumor agnostic study will evaluate approximately 60 mTOR inhibitor naïve patients in each of two independent study arms, or approximately 120 in total, comprised of patients with solid tumors harboring pathogenic inactivating alterations in either TSC1 or TSC2 genes. In November 2022, the FDA granted Fast Track designation to evaluate nab-sirolimus for this patient population.

nab-Sirolimus 100 mg/m2 is given weekly intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle. The primary endpoint is overall response rate per independent radiographic review (IRR) using RECIST v1.1. Other endpoints include duration of response, time to response, progression-free survival by IRR, overall survival, patient-reported quality of life, and safety.