Release Date: August 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Aadi Bioscience Inc (AADI, Financial) reported $6.2 million in net product sales for FYARRO in Q2 2024, a 15% increase over Q1.
- The company has achieved $51.1 million in cumulative sales for FYARRO since its launch in February 2022.
- PRECISION1 trial is fully enrolled with 120 patients and is expected to complete by the end of the year.
- Aadi Bioscience Inc (AADI) has a strong cash position with $78.6 million in cash, cash equivalents, and short-term investments, funding operations into Q4 2025.
- The company is exploring nab-sirolimus for larger indications across multiple types of mTOR-driven tumors, with promising potential in endometrial cancer and neuroendocrine tumors.
Negative Points
- Net loss for the second quarter was $14.6 million, compared to $18 million in the second quarter of 2023.
- Research and development expenses for the quarter amounted to $13.1 million, indicating high ongoing costs.
- The overall response rate for the TSC2 arm in the PRECISION1 trial was only 11%, which is relatively low.
- The company faces challenges in finding and treating PEComa patients due to the rarity of the condition.
- There is uncertainty regarding the future market adoption and commercial potential of nab-sirolimus beyond PEComa.
Q & A Highlights
Q: Given the first interim data, what kind of expectations do you have for TSC1 and TSC2 in the upcoming second interim data? What will be the key topics in your discussion with the FDA?
A: The second interim data will present the primary endpoint analysis on two-thirds of the patients, focusing on independently assessed overall response rate after a minimum of six months of follow-up. This data will form the basis for a discussion with the FDA on a potential path to submission. (David Lennon, CEO; Loretta Itri, CMO)
Q: What should we expect from the initial data update for the EEC and NET phase studies later this year?
A: For the EEC trial, we expect to provide a comprehensive report on the first cohort and partial information on the second cohort. For the NET program, we anticipate reporting on the first cohort of patients. These studies are open-label, so there will be no statistical issues in reporting the information. (Loretta Itri, CMO)
Q: Is there any scenario in which the design and execution of the remainder of PRECISION1 might be altered or changed?
A: The trial has been fully enrolled, and we anticipate reporting the full 120-patient data set in early 2025. We do not expect any adjustments to the trial at this point. (David Lennon, CEO)
Q: Are you still expecting incremental growth for FYARRO, and what would be the drivers of that growth?
A: We saw a strong rebound in demand across all key segments in Q2, and we expect continued incremental growth in Q3 and Q4. (David Lennon, CEO)
Q: Is there any particular tumor type you are favoring for future trials, or will this continue to be a pan-tumor approach?
A: PRECISION1 is a truly tumor-agnostic trial, and we do not bias the trial towards any specific tumor types. Our indication will be for a tumor-agnostic label, assuming we gain approval. (David Lennon, CEO)
Q: Are you planning to disclose data on distinct populations treated with more than three lines of treatment versus earlier lines of treatment in the next data release?
A: We will disclose the overall response rate. Any further breakdown will depend on the data we see from the patient population. (David Lennon, CEO)
Q: What are the expectations for the Phase 2 program in neuroendocrine tumors regarding efficacy and safety? Are there specific tumor types you expect to see the greatest impact in?
A: Historically, mTOR inhibitors have shown low overall response rates in NETs. We aim to show better response rates with nab-Sirolimus, which could guide to longer-term better outcomes for patients. (David Lennon, CEO; Loretta Itri, CMO)
Q: What is the market potential for nab-Sirolimus in PEComa, and how does it compare to other treatments?
A: PEComa is a very rare indication with 200-300 patients in the US. We believe we've penetrated most of the market, and any further growth will be incremental. (David Lennon, CEO)
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
