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Sep 30, 2021
Aadi Bioscience Q3 2021 Earnings Report
Aadi Bioscience reported financial results for the third quarter of 2021 and provided a business update, highlighting the FYARRO's NDA acceptance and key leadership appointments.
Key Takeaways
Aadi Bioscience reported a net loss attributable to common stockholders of $87.2 million for the third quarter of 2021, primarily driven by a non-cash impairment charge of $74.2 million. The company ended the quarter with $161.4 million in cash and cash equivalents, which is expected to fund operations into 2024.
Aadi merged with Aerpio Pharmaceuticals and closed a $155 million PIPE financing.
The FDA accepted Aadi’s NDA for FYARRO™ with a PDUFA target action date of November 26, 2021.
Key executive appointments were made, including a Chief Operating Officer.
A registrational trial in patients harboring TSC1 and TSC2 inactivating alterations is expected to be initiated by the end of 2021 or early 2022.
Aadi Bioscience
Aadi Bioscience
Forward Guidance
Aadi Bioscience anticipates several key developments, including potential regulatory approval and commercial launch of FYARRO, continued clinical trials, and sufficient cash to fund operations into 2024.
Positive Outlook
- Potential regulatory approval of FYARRO for advanced malignant PEComa.
- Successful commercialization of FYARRO.
- Advancement of clinical trials for FYARRO in various cancer types.
- Sufficient cash and cash equivalents to fund operations into 2024.
- Planned initiation of a tumor-agnostic registrational trial in mTOR inhibitor-naïve solid tumors.
Challenges Ahead
- Risks related to obtaining regulatory approval from the FDA for FYARRO.
- Uncertainties associated with the clinical development of FYARRO.
- Risk of unforeseen adverse reactions or side effects during FYARRO development.
- Potential failure to realize value from FYARRO.
- Risks related to estimates regarding future expenses and capital requirements.