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Mar 31
Crinetics Q1 2025 Earnings Report
Crinetics Pharmaceuticals reported its financial results for the first quarter ended March 31, 2025, highlighting progress in clinical development and financial stability.
Key Takeaways
Crinetics Pharmaceuticals reported a net loss of $96.8 million for Q1 2025, compared to $66.9 million in Q1 2024. Revenues were $0.4 million, down from $0.6 million in the prior year. The company maintains a strong cash position of $1.3 billion, projected to fund operations into 2029.
Paltusotine's New Drug Application (NDA) for acromegaly is on track with productive FDA engagement, with a PDUFA date of September 25, 2025.
The CALM-CAH Phase 3 study for atumelnant in congenital adrenal hyperplasia (CAH) is set to initiate with an uncompromising primary endpoint to normalize androstenedione levels.
Crinetics launched CrinetiCARE™, a patient support services platform and disease state education website.
The company reported $1.3 billion in cash, cash equivalents, and investment securities as of March 31, 2025, anticipated to provide runway into 2029.
Crinetics
Crinetics
Crinetics Revenue by Segment
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CapyFin.com Forward Guidance
Crinetics Pharmaceuticals expects its cash, cash equivalents, and investments to be sufficient to fund its current operating plan into 2029. For 2025, the company anticipates cash used in operations to be between $340 million and $380 million.
Positive Outlook
- FDA PDUFA target action date for paltusotine NDA is September 25, 2025.
- Crinetics expects to initiate the CAREFNDR Phase 3 trial of paltusotine in carcinoid syndrome in the second half of 2025.
- Crinetics expects to initiate the CALM-CAH Phase 3 study in adults with CAH and the Phase 2/3 study in pediatrics in the second half of 2025.
- Initiation of the Phase 2/3 study for atumelnant in ACTH-dependent Cushing's syndrome is expected to begin in the second half of 2025.
- IND-enabling activities for the TSH antagonist continue as expected, and the SST3 agonist development is ongoing.
Challenges Ahead
- Initial or topline data may not accurately reflect complete clinical study results.
- FDA and other regulatory authorities may not agree with the company's interpretation of results.
- Inability to obtain, maintain, and enforce patents and other intellectual property rights.
- Geopolitical events may disrupt business, clinical studies, manufacturing, or employee productivity.
- Unexpected adverse side effects or inadequate efficacy of product candidates may limit development or approval.