Loading...
•
Dec 31, 2020
Crinetics Q4 2020 Earnings Report
Crinetics reported financial results for Q4 and full year 2020 and announced 2021 clinical plans.
Key Takeaways
Crinetics reported a net loss of $21.6 million for the fourth quarter of 2020. The company is advancing paltusotine into a Phase 3 program for acromegaly and expects Phase 1 clinical proof-of-concept data for CRN04894 and CRN04777 in 2021.
Paltusotine is advancing into a Phase 3 program for acromegaly following an FDA meeting.
Phase 1 clinical proof-of-concept data for CRN04894 is expected in 1H 2021.
Phase 1 clinical proof-of-concept data for CRN04777 is expected in mid-2021.
Crinetics plans to initiate two Phase 3 studies in 2021.
Crinetics
Crinetics
Forward Guidance
Crinetics is poised to achieve several key milestones in 2021, including advancing paltusotine into Phase 3 and reporting Phase 1 data for CRN04894 and CRN04777.
Positive Outlook
- Initiate PATHFNDR-1 in 2Q 2021
- Initiate PATHFNDR-2 in 2H 2021
- Report preliminary safety, pharmacokinetic, and endocrine biomarker data from the single ascending dose portion of the CRN04894 trial in 1H 2021.
- Report preliminary safety and pharmacological effect data from the single ascending dose portion of the CRN04777 trial in mid-2021.
- Advance paltusotine into a Phase 3 program for acromegaly
Challenges Ahead
- The COVID-19 pandemic may disrupt Crinetics’ business
- Dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing
- 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 it expects
- Regulatory developments in the United States and foreign countries