Aadi Bioscience Q1 2024 Financial Results and Corporate Update

Aadi Bioscience, Inc., a precision oncology company specializing in treatments for cancers affected by the mTOR pathway, recently reported its financial results for the first quarter of 2024 and provided updates on its recent developments. The company announced that the PRECISION1 trial is now fully enrolled, targeting a range of solid tumors with TSC1 or TSC2 inactivating alterations. This trial is expected to undergo a two-thirds interim analysis by the third quarter of 2024 and aims for completion by the end of the year.

Dave Lennon, President and CEO of Aadi Bioscience, expressed satisfaction with the comprehensive enrollment of PRECISION1 and the ongoing progress of the development plan. The company anticipates releasing full results in early 2025. Additionally, Aadi’s Phase 2 trials in endometrioid-type endometrial cancer (EEC) and neuroendocrine tumors (NETs) are progressing well, with initial data expected later in the year.

In terms of commercial performance, FYARRO® sales for the first quarter of 2024 stood at $5.4 million. This figure represents an 8.8% decrease from the previous year, attributed to distributor ordering patterns and a lower number of new patient initiations at the start of the year. However, the company expects sales growth to pick up in the second quarter.

Aadi Bioscience also announced the termination of its collaboration and clinical supply agreement with Mirati/Bristol Myers Squibb to prioritize investments in its ongoing Phase 2 trials for EEC and NETs. Previously, the collaboration focused on evaluating a combination of nab-sirolimus and adagrasib in non-small cell lung cancer with a KRASG12C mutation.

Financially, Aadi revealed that its cash, cash equivalents, and short-term investments amounted to $88.3 million as of March 31, 2024, down from $108.8 million at the end of 2023. This funding is projected to sustain operations into the fourth quarter of 2025. The total revenue for the first quarter was $5.4 million, solely from FYARRO sales, while the net loss for the period was $18.3 million, up from $15.2 million in the same period last year.

Aadi Bioscience is committed to developing and commercializing therapies for cancers with mTOR pathway alterations using its unique nanoparticle albumin-bound (nab) technology combined with sirolimus. The company has received FDA approval for FYARRO, which is used to treat adult patients with locally advanced, unresectable, or metastatic malignant perivascular epithelioid cell tumor (PEComa).

The ongoing PRECISION1 trial investigates nab-sirolimus in mTOR inhibitor-naïve malignant solid tumors with TSC1 or TSC2 alterations. Additionally, the company is conducting two Phase 2 trials targeting difficult-to-treat mTOR-driven cancers, specifically NETs and advanced or recurrent EEC in combination with letrozole.

Aadi Bioscience’s management hosted a conference call and webcast to discuss the first-quarter results and provide additional business updates. The webcast was made available on the company's website, with a replay accessible for at least 30 days.

As Aadi Bioscience continues to advance its clinical trials and commercial efforts, it remains focused on leveraging its unique approach to mTOR inhibition to provide effective cancer treatments. The company is optimistic about the potential benefits and safety of FYARRO and aims to expand its market presence through ongoing research and development.