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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.
Mirati Therapeutics (MRTX) and Aadi Bioscience (AADI) announced a clinical collaboration on Oct. 12, 2022, to evaluate the combination of adagrasib, a KRASG12C inhibitor, and nab-sirolimus, an mTOR inhibitor, in patients with KRASG12C mutant non-small cell lung cancer (NSCLC). The Phase 1/2 trial aims to determine the optimal dosing, safety, and efficacy of the drug combination. Preclinical data showed enhanced anti-tumor efficacy when both agents were used together. The collaboration exemplifies their commitment to advancing targeted therapies for challenging cancers.
Aadi Bioscience, Inc. (NASDAQ: AADI) announced a private investment in public equity (PIPE) financing, issuing 3,373,526 shares at $12.50 each, and pre-funded warrants for up to 2,426,493 shares at $12.4999 per share. The gross proceeds are expected to be around $72.5 million, aimed at extending cash reserves into 2025. The funds will support the PRECISION 1 trial and expand FYARRO commercial efforts. The PIPE is set to close on September 26, 2022, and includes participation from various investment groups.
Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focusing on precision therapies for cancers with mTOR pathway gene alterations, announced its participation in several September investor conferences. These include Citi's Annual BioPharma Conference (Sept 7-8), Morgan Stanley's Global Healthcare Conference (Sept 12-14), and H.C. Wainwright's Investment Conference (Sept 12-14) in New York. Founder and CEO Neil Desai will present and participate in discussions, with webcasts available on the company's website. Aadi continues to develop its pipeline after receiving FDA approval for FYARRO® in November 2021.
Aadi Bioscience reported net product sales of $3.4 million for FYARRO in Q2 2022, marking the first full quarter post-launch. The company is advancing the PRECISION 1 trial, with preliminary data expected in 1H23. Significant partnerships with genomic testing leaders were established to enhance patient recruitment for the trial. Despite a $3.7 million non-cash impairment charge and a net loss of $18.3 million for the quarter, cash reserves of $118.7 million are projected to fund operations into 2024.
Aadi Bioscience (Nasdaq: AADI) will host a conference call and webcast on August 10, 2022 at 8:30 am EDT to discuss its Q2 2022 financial results and provide corporate updates. This biopharmaceutical company focuses on precision therapies for genetically defined cancers, particularly targeting mTOR pathway alterations. Notably, Aadi received FDA approval for FYARRO™ in November 2021 for treating malignant PEComa. For further details, visit aadibio.com.
Aadi Bioscience, Inc. (NASDAQ: AADI) has been included in the U.S. small-cap Russell 2000® Index and the broad-market Russell 3000® Index, effective June 24, 2022. This inclusion marks a significant milestone in Aadi's first year as a public company, enhancing its visibility among investors. Aadi's CEO, Neil Desai, expressed optimism about the company's progress, including the launch of FYARRO™ and the initiation of the PRECISION 1 trial targeting mTOR pathway alterations. Russell indexes are crucial benchmarks for $12 trillion in assets.
Aadi Bioscience, a biopharmaceutical company focused on precision therapies for genetically defined cancers, will participate in the Jefferies Global Healthcare Conference in New York from June 8-10, 2022. CEO Neil Desai is set to present during a fireside chat on June 9 at 10am ET. A live webcast will be accessible via the company’s website, with a replay available for 30 days post-event. Aadi is known for its FDA-approved treatment FYARRO for PEComa and has initiated a Phase 2 trial called PRECISION 1 targeting mTOR inhibitor-naïve solid tumors.
Aadi Bioscience (NASDAQ: AADI) has appointed Marcy Graham as Senior Vice President of Investor Relations and Corporate Communications. Graham brings over 20 years of experience in biotech investor relations, having previously worked at Poseida Therapeutics and Mirati Therapeutics. Her role will focus on enhancing Aadi's investor base and corporate visibility following the company's transition to public markets and the approval of its first commercial product, FYARRO. The company aims to advance its pipeline for precision oncology therapies targeting genetically defined cancers.
Aadi Bioscience (NASDAQ: AADI) announced promising results for its drug nab-sirolimus in treating patients with advanced malignant PEComa at the 2022 ASCO Annual Meeting. Data from the AMPECT trial and an expanded access program indicated that 64% of patients with TSC1 or TSC2 alterations responded positively to treatment, compared to a 39% response rate for all patients. The findings bolster the rationale for the ongoing PRECISION 1 Phase 2 trial. FYARRO™, the drug's commercial name, is FDA-approved for locally advanced, unresectable malignant PEComa.
Aadi Bioscience, a biopharmaceutical company focused on precision therapies for genetically-defined cancers, will participate in the H.C. Wainwright Global Investment Conference from May 23-26, 2022. Founder and CEO Neil Desai and the executive team will present virtually on May 24, starting at 7:00 AM EDT. Aadi recently received FDA approval for its drug FYARRO for treating advanced malignant PEComa and has launched it commercially. The company has also initiated the PRECISION 1 trial for solid tumors with specific genetic alterations.
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