Release Date: May 08, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Aadi Bioscience Inc (AADI, Financial) announced the full enrollment of the PRECISION1 trial, which is a significant milestone in assessing nab-sirolimus for patients with solid tumors.
- The company reported sustained tumor reductions in the PRECISION1 trial interim analysis, demonstrating early, deep, and durable responses across multiple tumor types.
- Aadi Bioscience Inc (AADI) has initiated Phase 2 trials for endometrial cancer and neuroendocrine tumors, targeting mTOR-driven cancers with nab-sirolimus, which has shown promising pre-clinical results.
- FYARRO, Aadi Bioscience Inc (AADI)'s commercial product, continues to perform well despite a slight decrease in Q1 sales, maintaining its position as the preferred treatment for malignant PEComa.
- The company maintains a healthy financial position with $88.3 million in cash and investments, and a cash runway extending into Q4 2025.
Negative Points
- FYARRO net product sales decreased by 8.8% from the previous year, attributed to changes in distributor ordering patterns and fewer new commercial patient initiations.
- The company reported a net loss of $18.3 million for the first quarter of 2024, an increase from the $15.2 million loss in the same quarter of the previous year.
- Research and development expenses increased to $13.6 million, up from $11 million in the prior year, reflecting higher costs associated with ongoing clinical trials.
- Aadi Bioscience Inc (AADI) terminated its collaboration and supply agreement with Mirati now BMS, which was evaluating nab-sirolimus in combination with adagrasib for KRAS-mutant cancers.
- There is a potential impact on FYARRO sales due to cannibalization at top accounts where robust enrollment into clinical trials is observed.
Q & A Highlights
Q: Can you provide insights into the expectations for the initial data readout for the EEC and NET trials later this year?
A: David Lennon, President and CEO, mentioned that the initial part of these Phase 2 studies will involve approximately 10 patients each, with early efficacy and safety data expected by year-end. Loretta Itri, Chief Medical Officer, added that recruitment is progressing well and aligns with the Simon's 2-stage design of the trials.
Q: What impact has the enrollment into the PRECISION1 trial had on FYARRO sales?
A: David Lennon explained that the correlation between reduced commercial business at some large accounts and their status as PRECISION1 sites suggests that some patients may have been enrolled in the trial instead of being treated commercially. This effect is seen as a temporary shift due to the trial's enrollment dynamics.
Q: What are the baseline features of the full population in the PRECISION1 trial compared to the first 40 patients?
A: David Lennon confirmed that the baseline features are consistent with those of the first 40 patients, indicating a heavily pre-treated and diverse set of tumor types, although full data will only be available after the interim analysis.
Q: Why was the collaboration with Mirati on the G12C inhibitor and nab-sirolimus terminated?
A: David Lennon clarified that the decision was strategic and financial, focusing resources on more promising programs like the endometrial and NET trials, rather than due to any efficacy or safety concerns from the early data.
Q: What are the financial implications of ending the collaboration with Mirati?
A: Scott Giacobello, CFO, indicated that while there will be cost savings from terminating the collaboration, specific financial details have not been disclosed.
Q: What benchmarks and expectations are set for the interim analysis of the EEC program?
A: Loretta Itri stated that the study aims for an overall response rate exceeding 20% in the first cohort of 10 patients, with the potential for higher rates as the study progresses.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
