Tuesday, Aadi Bioscience Inc. (NASDAQ:AADI) announced it will halt the registration-intended PRECISION1 trial of nab-sirolimus in patients with solid tumors harboring TSC1 or TSC2 inactivating alterations.

An analysis by the Independent Data Monitoring Committee demonstrated that the study was unlikely to exceed an efficacy threshold necessary to support an accelerated approval, the key goal of this Phase 2 study. 

The approximately 25 patients in PRECISION1 still benefiting from nab-sirolimus will be eligible for transition to a planned expanded access protocol. A complete analysis of the PRECISION1 trial will be provided later.

Also Read: Cancer Player Aadi Bioscience Downgraded: Analyst Highlights ‘Worse Than Expected’ Response Rates.

Aadi will now focus on preserving cash while maximizing its 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 delivered sales of $6.2 million.

To further preserve cash runway, Aadi will pause new enrollment but continue dosing previously enrolled patients in two ongoing Phase 2 trials of nab-sirolimus for advanced or recurrent endometrioid-type endometrial cancer (EEC) and neuroendocrine tumors (NETs).

Both studies have enrolled sufficient patients (n=20 and n=10 for EEC and NETs, respectively) to assess initial efficacy signals later this year.

Aligned with these pipeline adjustments, the Company is reducing its R&D workforce by 80%. Together, these actions extend the cash runway into at least the second half of 2026.

“While nab-sirolimus showed monotherapy activity in the study population, the trial fell short of delivering what we believe would be required to support an accelerated approval in the broad TSC1/TSC2 inactivating mutations indication. We look forward to providing the full trial analysis at a later date,” said David Lennon, President and CEO of Aadi Bioscience.

Price Action: AADI stock is down 14.8% at $1.39 during the premarket session at last check Wednesday.

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