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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 (NASDAQ: AADI) reported Q3 2024 financial results with FYARRO® sales reaching $7.2 million, showing 21% year-over-year growth and 17% quarter-over-quarter increase. The company reported cash reserves of $62.6 million, expected to fund operations into at least 2H 2026. Operating expenses were $20.6 million, down from $23.8 million in the prior year quarter. Net loss improved to $12.5 million compared to $16.3 million in Q3 2023. The company is winding down the PRECISION1 trial while maintaining Phase 2 trials for endometrial cancer and neuroendocrine tumors.
Aadi Bioscience (NASDAQ: AADI) has announced it will release its third quarter 2024 financial results and provide corporate updates on Wednesday, November 6, 2024. The company will make this information available on the Investors & News section of their website at aadibio.com.
Aadi Bioscience (NASDAQ: AADI) has announced the halt of its PRECISION1 trial for nab-sirolimus in solid tumors with TSC1 or TSC2 alterations due to unlikely regulatory approval. The company will now focus on its FYARRO® commercial business for PEComa and conduct a strategic review. To extend cash runway into at least 2H 2026, Aadi will:
- Adjust ongoing Phase 2 trials
- Reduce R&D headcount by 80%
- Pause new enrollment in EEC and NET trials
- Continue dosing previously enrolled patients
FYARRO® sales reached $6.2M in Q2. The company will provide a full analysis of the PRECISION1 trial later and has hired an advisory firm to explore options for maximizing shareholder value.
Aadi Bioscience (NASDAQ: AADI) reported financial results for Q2 2024 and provided a corporate update. FYARRO® sales reached $6.2 million, showing a 15% quarter-over-quarter growth. The company plans an interim analysis of the PRECISION1 trial in Q3 2024. Key highlights include:
- Increased demand for FYARRO across new and existing accounts
- Fully enrolled PRECISION1 trial exploring nab-sirolimus in solid tumors with TSC1 or TSC2 alterations
- Ongoing enrollment in two additional Phase 2 trials
- Cash position of $78.6 million, expected to fund operations into Q4 2025
- Net loss of $14.6 million for Q2 2024, compared to $18.0 million in Q2 2023
Aadi Bioscience (NASDAQ: AADI), a commercial-stage precision oncology company, has announced it will host a conference call and live webcast on August 7, 2024, at 8:30 am EDT to report its second quarter 2024 financial results and provide recent corporate updates. The company focuses on developing and commercializing therapies for cancers with alterations in the mTOR pathway.
Participants can access the webcast on the 'Investors & News' page of Aadi Bioscience's website. For telephone participation, registration is required in advance. Upon registration, participants will receive a confirmation email with dial-in details and unique access codes. A replay of the conference call and webcast will be available on the company's website for at least 30 days after the event.
Aadi Bioscience (NASDAQ: AADI), a commercial-stage precision oncology company, announced its participation in the Jefferies Healthcare Conference in New York on June 5-6, 2024.
CEO Dave Lennon, Ph.D., will be involved in a fireside chat scheduled for June 5, 2024, from 2:00 PM to 2:25 PM EDT. The event will be webcast live on Aadi Bioscience's investor relations webpage and available for replay for 30 days.
Aadi Bioscience presented new nonclinical data at the ASCO Annual Meeting showing that nab-sirolimus achieved higher intratumoral drug concentrations, stronger mTOR target inhibition, and greater antitumor activity compared to IV and oral mTOR inhibitors in a xenograft model. These findings support further clinical studies of nab-sirolimus, either alone or in combination therapies. The data will be published in the Journal of Clinical Oncology.
Aadi will also present a poster on a Phase 2 trial of nab-sirolimus plus letrozole in advanced or recurrent endometrioid-type endometrial cancer. This trial aims to evaluate the efficacy and safety of the combination, exploring its potential to offer additive anti-tumor activity for EEC patients.
Endometrial cancer is a significant focus due to its rising mortality rates, and Aadi's study aims to address the unmet needs in this difficult-to-treat cancer type.
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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