Aerpio Pharmaceuticals(AADI)
Search documents
Aerpio Pharmaceuticals(AADI) - 2023 Q4 - Annual Results
2024-03-12 16:00
Exhibit 99.1 Aadi Bioscience Announces Financial Results for the Fourth Quarter and Full-Year 2023 and Provides Corporate Update FYARRO® sales of $6.3 million for Q4 2023 and $24.4 million for FY 2023 representing year-over-year growth of 21% and 60%, respectively Registration-directed PRECISION1 trial of nab-sirolimus in solid tumors with TSC1 or TSC2 inactivating alterations on track to complete enrollment by May; two-thirds interim analysis planned for Q3 2024 Phase 2 trials in Endometrial Cancer and Neu ...
Aerpio Pharmaceuticals(AADI) - 2023 Q4 - Annual Report
2024-03-12 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _______________________________________________ FORM 10-K _______________________________________________ (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-38560 _______________________________ ...
Aadi Bioscience Announces Publication of Long-Term Efficacy and Safety Data Further Supporting FYARRO® for the Treatment of Malignant PEComa
Prnewswire· 2024-03-01 21:08
After 3 years of follow-up in AMPECT trial, confirmed clinically meaningful overall response rate, including multiple patients with complete responses Demonstrated 40 months median duration of response and median survival >53 months Historically, median survival has ranged from 16 to 29 months in the setting of metastatic/unresectable malignant PEComa1,2 LOS ANGELES, March 1, 2024 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing prec ...
Aadi Bioscience Announces Poster Presentations at the 2024 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium
Prnewswire· 2024-01-26 21:05
Real-world genomic analysis highlights unmet medical need in GU cancer patients with TSC1/2 inactivating alterations LOS ANGELES, Jan. 26, 2024 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for patients with mTOR pathway alterations, today announced poster presentations at the 2024 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium, taking place January 25-27, 2024, in San Francisco, C ...
Aadi Bioscience Announces Poster Presentations at the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium
Prnewswire· 2024-01-19 21:05
- New real-world analysis highlights unmet medical need in GI cancer patients with TSC1/2 alterations- LOS ANGELES, Jan. 19, 2024 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for patients with mTOR pathway alterations, today announced poster presentations at the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium, taking place January 18-20, 2024, in San Francisco, CA. Ab ...
Aerpio Pharmaceuticals(AADI) - 2023 Q3 - Earnings Call Transcript
2023-11-08 17:26
Financial Data and Key Metrics Changes - Aadi Bioscience reported FYARRO sales of $6 million in Q3 2023, representing a 40% growth compared to the same period in 2022, with cumulative sales reaching $80 million for the first nine months of 2023 [9][16] - Research and development expenses increased to $11.9 million in Q3 2023 from $8.8 million in the prior year, primarily due to the ongoing PRECISION 1 trial [16] - Selling, general and administrative expenses rose to $11.2 million in Q3 2023, up from $9.9 million in the same period last year, attributed to infrastructure build-out and increased marketing expenses [16] - The net loss for Q3 2023 was $16.3 million, compared to a net loss of $14.4 million in the prior year [17] Business Line Data and Key Metrics Changes - The company is executing on its development strategy with the initiation of two Phase 2 studies of nab-Sirolimus, one in combination with standard care in endometrial cancer and the other as a single agent in neuroendocrine tumors [9][10] - The PRECISION 1 trial is designed to evaluate nab-Sirolimus across various tumor types with TSC1 or TSC2 mutations, with over 25 tumor types currently enrolled [12][13] Market Data and Key Metrics Changes - Approximately 16,000 patients with TSC1 or TSC2 mutations are estimated to exist across various tumor types, representing a significant market opportunity for nab-Sirolimus [10] - The unmet need in TSC1 and TSC2 mutated cancers is substantial, with these mutations found in a wide range of tumor types, including lung, gastrointestinal, and gynecological cancers [11] Company Strategy and Development Direction - The company aims to build a leading precision oncology platform, focusing on the potential of nab-Sirolimus for treating solid tumors with TSC1 or TSC2 mutations [7][8] - Aadi Bioscience plans to present early interim data from the PRECISION 1 trial by mid-December 2023, with full enrollment expected by spring 2024 and study completion by the end of 2024 [15][18] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the upcoming interim analysis and the potential of nab-Sirolimus, highlighting the significant market opportunities in cancers with TSC1 or TSC2 mutations [18][19] - The company is well-capitalized, ending Q3 2023 with $119.3 million in cash, which is expected to fund operations into 2025 [16] Other Important Information - The PRECISION 1 trial is designed as a tumor-agnostic study, allowing for independent evaluation of each arm, with two preplanned interim analyses scheduled [12][14] - The company is leveraging a just-in-time mechanism to open clinical trial sites rapidly, enhancing patient access [13] Q&A Session Summary Question: What efficacy is needed to stop the second interim analysis early? - Management refrained from commenting on specific efficacy requirements, noting that the context of response rates and duration in the study would be considered [19] Question: What is the duration of therapy in the PEComa market for FYARRO? - Management indicated that the duration of therapy is consistent with clinical trial observations [19] Question: What is the minimum amount of post-baseline scans insured for the initial interim analysis? - At least two post-baseline scans are guaranteed for each patient [24] Question: Was the second interim analysis always part of the plan? - Yes, the second interim analysis was always included in the statistical analysis plan as part of the adaptive design [25] Question: Will co-mutation status be disclosed during the interim analysis? - Co-mutation status will not be presented at this time due to insufficient data for robust analysis [36] Question: How many sites are open for the endometrial program, and when will initial data be available? - The number of sites was not disclosed, but management expressed optimism about community engagement and expects updates in 2024 [38]
Aerpio Pharmaceuticals(AADI) - 2023 Q3 - Quarterly Report
2023-11-07 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ______________________________________ FORM 10-Q ______________________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to ______________ Commission File Number: 001-38560 ___________ ...
Aerpio Pharmaceuticals(AADI) - 2023 Q2 - Earnings Call Transcript
2023-08-09 15:30
Aadi Bioscience, Inc. (NASDAQ:AADI) Q2 2023 Earnings Conference Call August 9, 2023 8:30 AM ET Company Participants Marcy Graham - SVP of IR and Corporate Communications Scott Giacobello - Interim CEO, President, and CFO Loretta Itri - Chief Medical Officer Conference Call Participants Joseph Catanzaro - Piper Sandler Ahu Demir - Ladenburg Thalmann & Company Boris Peaker - Cowen and Company Roger Song - Jefferies LLC Operator Good day, and thank you for standing by. Welcome to the Aadi Bioscience, Incorpora ...
Aerpio Pharmaceuticals(AADI) - 2023 Q2 - Quarterly Report
2023-08-08 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ______________________________________ FORM 10-Q ______________________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to ______________ Commission File Number: 001-38560 ________________ ...
Aerpio Pharmaceuticals(AADI) - 2023 Q1 - Earnings Call Transcript
2023-05-10 15:33
Aadi Bioscience, Inc. (NASDAQ:AADI) Q1 2023 Earnings Conference Call May 10, 2023 8:30 AM ET Company Participants Marcy Graham - Senior Vice President of Investor Relations and Corporate Communications Neil Desai - Founder and Executive Chairman Scott Giacobello - Interim Chief Executive Officer, President, and Chief Financial Officer Loretta Itri - Chief Medical Officer Conference Call Participants Roger Song - Jefferies LLC Joseph Catanzaro - Piper Sandler Boris Peaker - Cowen and Company Ahu Demir - Lade ...