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Sep 30, 2023
Crinetics Q3 2023 Earnings Report
Crinetics reported third quarter results, highlighted by positive Phase 3 PATHFNDR-1 study results and progress in other clinical programs.
Key Takeaways
Crinetics Pharmaceuticals reported its Q3 2023 financial results, featuring a net loss of $57.5 million and revenues of $0.3 million. The company highlighted the success of its Phase 3 PATHFNDR-1 study for paltusotine in acromegaly and the anticipated data releases from other ongoing studies.
Phase 3 PATHFNDR-1 study met primary and all secondary endpoints.
Enrollment completed in paltusotine's Phase 3 PATHFNDR-2 study with topline data expected in Q1 2024.
Initial data from Phase 2 study of paltusotine in carcinoid syndrome expected in December 2023.
Strengthened balance sheet with $350 million public offering.
Crinetics
Crinetics
Forward Guidance
Crinetics anticipates several key milestones in the near future, including topline data from the PATHFNDR-2 study and initial data from the Phase 2 study of paltusotine in carcinoid syndrome. The company plans to submit an NDA for paltusotine in 2024, pending successful data from the PATHFNDR-2 study.
Positive Outlook
- Paltusotine NDA submission anticipated in 2024.
- Initial data from Phase 2 study of paltusotine in carcinoid syndrome expected December 2023.
- CRN04894 studies for Cushing’s disease and congenital adrenal hyperplasia (CAH).
- Based on successful Phase 1 studies demonstrating pharmacologic proof-of-concept, Crinetics is advancing clinical studies of CRN04894 in both Cushing’s disease and congenital adrenal hyperplasia.
- Data from the ongoing studies are expected in the second half of 2024.
Challenges Ahead
- The COVID-19 pandemic and other geopolitical events may disrupt Crinetics’ business and that of the third parties on which it depends, including delaying or otherwise disrupting its clinical studies 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.
- The company’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing.
- Clinical studies and preclinical studies may not proceed at the time or in the manner expected, or at all.
- The timing and outcome of research, development and regulatory review is uncertain, and Crinetics’ drug candidates may not advance in development or be approved for marketing.