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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 biopharmaceutical firm, will host a conference call on March 28, 2023, at 8:30 AM EDT to discuss its fourth quarter and full-year 2022 financial results and corporate updates. The call will be accessible via live webcast on their website. Aadi specializes in precision therapies for genetically-defined cancers, notably receiving FDA approval for FYARRO® to treat advanced malignant perivascular epithelioid cell tumors. Additionally, they are initiating the PRECISION 1 trial targeting solid tumors with specific genetic alterations.
Aadi Bioscience, Inc. (NASDAQ: AADI) announced the resignation of CEO Brendan Delaney due to personal reasons, with CFO Scott Giacobello appointed as Interim CEO. Neil Desai, the founder and former CEO, will assist during the transition. The board is currently searching for a permanent CEO. Aadi continues to advance the development of FYARRO nab-sirolimus, targeting solid tumors with TSC1 and TSC2 mutations while supporting patients with PEComa. Giacobello highlighted a strong financial position and a commitment to delivering solutions for unmet needs in oncology.
Aadi Bioscience, Inc. (NASDAQ: AADI) has announced its participation in the 43rd Annual Healthcare Conference from March 6-8, 2023, in Boston, MA. CEO Brendan Delaney will join a panel titled 'Tumor Agnostic Development' on March 8, 2023, at 9:10 AM ET. The event will be webcast live on the company's investor relations website and available for replay for 30 days. Aadi focuses on precision therapies targeting genetically-defined cancers, having received FDA approval for its drug FYARRO® for advanced tumors. The company is also conducting the PRECISION 1 trial for tumors with specific genetic alterations.
Aadi Bioscience has presented three clinical trial posters at the CTOS 2022 Annual Meeting. Highlighted were the trial-in-progress for PRECISION 1, aimed at treating solid tumors with TSC1/TSC2 alterations, and the AMPECT trial's long-term results. The AMPECT study noted a median Duration of Response (DoR) exceeding 3 years and Overall Survival (OS) of 53.1 months. The data also underscored the safety profile of nab-sirolimus, with manageable adverse events not affecting treatment efficacy. These findings bolster Aadi's position in precision oncology.
Aadi Bioscience (AADI) announced a significant corporate update, highlighting a successful $72.5 million PIPE financing that extends its cash runway into 2025. The company reported a 24% increase in FYARRO® (nab-sirolimus) sales, totaling $4.2 million for Q3 2022. The PRECISION 1 trial is on track, with preliminary data expected in H1 2023. A leadership transition is set for January 1, 2023, with Neil Desai becoming Executive Chairman and Brendan Delaney stepping in as CEO. Aadi has also signed a collaboration with Mirati Therapeutics to study the combination of adagrasib and nab-sirolimus.
Aadi Bioscience announced a leadership transition, with Neil Desai becoming Executive Chairman and Brendan Delaney promoted to President and CEO, effective January 1, 2023. Desai has led the company since its inception, guiding the approval of FYARRO for advanced malignant PEComa and initiating the PRECISION 1 trial for broader cancer indications. The transition comes as Aadi has grown significantly, raising $155M during its public listing in August 2021 and $72.5 million in September 2022. Delaney previously held executive roles at Constellation Pharma and Immunomedics, bringing extensive commercial experience.
Aadi Bioscience, a biopharmaceutical company focused on precision therapies for genetically defined cancers, will present at three major conferences in November 2022. These include the H.C. Wainwright Precision Oncology Virtual Conference on November 14, the Jefferies London Healthcare Conference from November 15-17, and the Piper Sandler Healthcare Conference from November 29 to December 1. CEO Neil Desai and COO Brendan Delaney will engage in discussions highlighting the company's advancements, including the FDA-approved FYARRO® treatment for certain cancer patients.
Aadi Bioscience, Inc. (NASDAQ: AADI) announced preclinical data showcasing the synergistic potential of combining KRAS inhibitors with nab-sirolimus for treating KRAS-mutated cancers. The data will be presented at the 34th EORTC-NCI-AACR Symposium in Barcelona on October 27, 2022. This study indicates that the combination significantly enhances response rates against KRAS G12C mutant lung and bladder cancers. Aadi aims to address adaptive resistance seen in KRAS mutations, emphasizing the role of nab-sirolimus in future clinical applications.
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.
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