Crinetics Q2 2023 Earnings Report
Key Takeaways
Crinetics Pharmaceuticals reported revenue of $1 million and a net loss of $51.0 million for the second quarter of 2023. The PATHFNDR program for acromegaly continues to progress, with topline results from the Phase 3 PATHFNDR-1 study expected in September and enrollment completed in the Phase 3 PATHFNDR-2 study. The company has suspended development of CRN04777.
Topline data from paltusotine’s Phase 3 PATHFNDR-1 study expected in September 2023.
Completed enrollment in paltusotine’s Phase 3 PATHFNDR-2 study with topline data expected in the first quarter of 2024.
Paltusotine NDA submission anticipated in 2024.
Development of CRN04777 suspended.
Crinetics
Crinetics
Forward Guidance
Crinetics expects topline data from the PATHFNDR-1 study in September 2023 and from the PATHFNDR-2 study in Q1 2024. They anticipate submitting an NDA for paltusotine in 2024.
Positive Outlook
- Topline data from paltusotine’s Phase 3 PATHFNDR-1 study expected in September 2023.
- Enrollment completed in paltusotine’s Phase 3 PATHFNDR-2 study.
- Paltusotine NDA submission anticipated in 2024.
- Phase 2 open-label study of paltusotine in carcinoid syndrome ongoing with preliminary data anticipated in the fourth quarter of 2023.
- CRN04894 studies in Cushing’s disease and congenital adrenal hyperplasia are ongoing with data expected in 2024.
Challenges Ahead
- Development of CRN04777 suspended.
- Net loss for the three months ended June 30, 2023, was $51.0 million.
- The company 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 and other geopolitical events may disrupt Crinetics’ business and that of the third parties on which it depends.
- Unexpected adverse side effects or inadequate efficacy of the company’s product candidates that may limit their development, regulatory approval and/or commercialization.