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Dec 31, 2023
Crinetics Q4 2023 Earnings Report
Reported financial results for Q4 and full year 2023 and provided a corporate update.
Key Takeaways
Crinetics Pharmaceuticals reported its Q4 and full year 2023 financial results, highlighting the progress of paltusotine and CRN04894, and a $350 million private placement equity financing to extend the cash runway into 2028.
Phase 3 PATHFNDR-1 study achieved primary and all secondary endpoints.
Reported positive initial data from Phase 2 study of paltusotine in carcinoid syndrome.
Completed enrollment in Phase 3 PATHFNDR-2 study of paltusotine.
Strengthened balance sheet with $350 million private placement financing.
Crinetics
Crinetics
Forward Guidance
Crinetics anticipates several key milestones, including topline results from the Phase 3 PATHFNDR-2 study in March 2024, topline results from the Phase 2 study of paltusotine in carcinoid syndrome in the first half of 2024, and a paltusotine NDA submission in the second half of 2024.
Positive Outlook
- Topline results from the Phase 3 PATHFNDR-2 study of paltusotine are expected in March 2024.
- Topline results from the Phase 2 study of paltusotine in carcinoid syndrome are expected in the first half of 2024.
- Paltusotine NDA submission is anticipated in the second half of 2024.
- Initial results from ongoing Phase 2 study of oral CRN04894 in congenital adrenal hyperplasia (CAH) are expected in the second quarter of 2024.
- Cash, cash equivalents and short-term investments will be sufficient to fund its current operating plan into 2028.
Challenges Ahead
- Topline data may change following a more comprehensive review.
- The FDA and other regulatory authorities may not agree with Crinetics' interpretation of the results.
- Unexpected adverse side effects or inadequate efficacy of the company’s product candidates that may limit their development, regulatory approval and/or commercialization.
- Crinetics' dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing.
- Any future impacts to Crinetics' business resulting from geopolitical developments outside their control.