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 - Earnings Call Transcript