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Aadi Bioscience, Inc. (NASDAQ: AADI) is a commercial-stage precision oncology company focused on the development and commercialization of therapies for cancers with alterations in the mTOR pathway. The company's lead asset, FYARRO® (sirolimus albumin-bound nanoparticles for injectable suspension), is an mTOR inhibitor targeting cancers driven by genetic alterations in mTOR pathway genes. Aadi is committed to bringing transformational therapies to cancer patients with mTOR pathway driver alterations such as those in the TSC1 or TSC2 genes.
Aadi Bioscience has 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 designed to improve delivery, stability, solubility, and targeting compared to traditional mTOR inhibitors and is being evaluated in various clinical trials. The company's innovative approach combines nanoparticle albumin-bound (nab) technology with the potent mTOR inhibitor, sirolimus.
The company's clinical pipeline includes the Phase 2 PRECISION1 trial, a tumor-agnostic registration-intended study exploring nab-sirolimus in patients with solid tumors harboring TSC1 or TSC2 inactivating alterations. The trial is expected to complete enrollment by the end of 2024, with interim analysis anticipated in Q3 2024.
In addition to PRECISION1, Aadi is conducting two other Phase 2 trials: one in advanced or recurrent endometrioid-type endometrial cancer (EEC) in combination with letrozole, and another in neuroendocrine tumors (NETs). Endometrial cancer is a common type of gynecologic cancer, and nab-sirolimus has shown promise in combination therapies for these difficult-to-treat cancers.
Financially, Aadi's Q1 2024 revenue from FYARRO® sales reached $5.4 million, reflecting a strong market presence as the preferred treatment for malignant PEComa. The company's robust financial position, with $88.3 million in cash and short-term investments as of March 2024, is expected to fund operations into Q4 2025.
Headquartered in Los Angeles, Aadi Bioscience is led by a team of industry veterans with extensive experience in developing and commercializing blockbuster oncology products. The company's mission is to unlock the full potential of mTOR inhibition and bring hope to patients with genetically-defined cancers.
Aadi Bioscience, a precision oncology company, announced Q1 2024 financial results with FYARRO sales of $5.4 million. The PRECISION1 trial is fully enrolled, with an interim analysis planned for Q3 2024. Phase 2 trials in EEC and NETs are progressing well. Despite an 8.8% decrease in sales due to distributor patterns, FYARRO continues to be a preferred PEComa treatment. The company ended Q1 with $88.3 million in cash. A conference call will discuss these updates.
Aadi Bioscience, a precision oncology company, will report its Q1 2024 results and provide corporate updates on May 8, 2024. The company focuses on developing therapies for cancers with alterations in the mTOR pathway. A conference call and webcast will be held, allowing participants to access the call through the company's website or via telephone registration. A replay will be available for 30 days.
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