Crinetics Q3 2022 Earnings Report
Key Takeaways
Crinetics Pharmaceuticals reported a net loss of $41.9 million for the third quarter of 2022, with revenues of $0.5 million. The company's research and development expenses were $32.0 million, and general and administrative expenses were $11.9 million. Unrestricted cash, cash equivalents, and investments totaled $368.4 million as of September 30, 2022.
Phase 3 PATHFNDR-1 trial in acromegaly fully enrolled and on track for topline data in Q3 2023.
Paltusotine lowered and maintained IGF-1 at levels comparable to prior injected SRL therapy for up to 103 weeks in acromegaly patients.
Received a UK Medicines and Healthcare products Regulatory Agency (MHRA) Innovation Passport for CRN04777 for the treatment of congenital hyperinsulinism.
Strengthened leadership team with appointment of Dana Pizzuti, M.D. as chief development officer.
Crinetics
Crinetics
Forward Guidance
Crinetics plans to submit data from the ongoing Phase 3 clinical trials of paltusotine in acromegaly to regulators in support of applications seeking approval for the use of paltusotine in acromegaly patients and advance CRN04777 and CRN04894 toward patient trials.
Positive Outlook
- Topline data from PATHFNDR-1 are expected in the third quarter of 2023.
- Topline data from paltusotine’s second Phase 3 trial, PATHFNDR-2, are expected in the fourth quarter of 2023.
- Crinetics plans to submit data from the PATHFNDR trials to regulatory authorities in support of applications seeking approval for the broad use of paltusotine for all acromegaly patients who require pharmacotherapy.
- The ILAP aims to reduce the time to market for designated medicines by enabling enhanced coordination between sponsors and MHRA leading up to Marketing Authorization Application (MAA) submissions
- The ILAP provides the opportunity for accelerated MAA reviews.
Challenges Ahead
- Topline data that we report may change following a more comprehensive review of the data related to the clinical trials and such data may not accurately reflect the complete results of a clinical trial, and the FDA and other regulatory authorities may not agree with our interpretation of such results.
- We may not be able to obtain, maintain and enforce our patents and other intellectual property rights, and it may be prohibitively difficult or costly to protect such rights.
- The COVID-19 pandemic may disrupt Crinetics’ business and that of the third parties on which it depends, including delaying or otherwise disrupting its clinical trials and preclinical studies, manufacturing and supply chain, or impairing employee productivity.
- Unexpected adverse side effects or inadequate efficacy of the company’s product candidates that may limit their development, regulatory approval and/or commercialization.
- Crinetics may use its capital resources sooner than expected.