On May 8, 2025 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, reported financial results for the first quarter ended March 31, 2025 (Press release, Crinetics Pharmaceuticals, MAY 8, 2025, View Source [SID1234652740]).
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"Crinetics is stronger than we have ever been," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "We are approaching a pivotal moment in our company’s history. We are on-track with the FDA review and preparations for the anticipated launch of paltusotine for acromegaly, while also moving forward with multiple late-stage studies. We are excited to unveil our Phase 3 study for adult CAH patients aimed at demonstrating normalization of androstenedione levels with physiological glucocorticoid replacement to define an uncompromising standard of care in CAH. We’re also excited to start the clinical development program for CRN09682, the first candidate from our nonpeptide drug conjugate platform. We look forward to sharing more about this and our other early programs at our upcoming R&D Day. With a robust financial foundation and strong momentum across clinical, regulatory, and commercial fronts, we are poised to deliver on our mission of advancing innovative therapeutics to improve the lives of patients with endocrine diseases around the world."
First Quarter 2025 and Recent Highlights:
The review process for paltusotine’s New Drug Application (NDA) for acromegaly appears to be on track with productive and consistent engagement with the Food & Drug Administration (FDA).
Launch of CrinetiCARE patient support services platform and a patient-focused disease state education website.
Marketing authorization application (MAA) validated by the European Medicines Agency (EMA) for paltusotine for the treatment of acromegaly, consistent with a timeline for potential EMA decision in the first half of 2026. The EMA also granted Orphan Drug Designation (ODD) for paltusotine for the treatment of acromegaly, further highlighting the level of unmet need, and the potential for paltusotine to offer significant benefit to patients.
Phase 2 TouCAHn open-label study of atumelnant in congenital adrenal hyperplasia (CAH) reported positive results. Atumelnant administration was shown to result in rapid, substantial and sustained statistically significant reduction in androstenedione (A4) levels, the key biomarker for disease control. Atumelnant was well-tolerated and demonstrated significant clinical improvements. We have also initiated an open-label extension study.
Phase 3 CALM-CAH study is designed with an uncompromising primary endpoint to demonstrate atumelnant’s potential ability to normalize androstenedione (A4) levels with physiological glucocorticoid (GC) replacement.
IND clearance for CRN09682, the first candidate from the nonpeptide drug conjugate (NDC) platform. A "Study May Proceed" letter has been received to allow us to begin a Phase 1/2 dose escalation study of CRN09682 with an expansion phase for the treatment of metastatic or locally advanced SST2-positive neuroendocrine tumors and other SST2-expressing solid tumors.
Key Upcoming Milestones
FDA PDUFA target action date of September 25, 2025 for paltusotine NDA for the treatment and maintenance therapy of acromegaly.
R&D Day scheduled for June 26, 2025, where Crinetics will provide updates on its early-stage pipeline, with a focus on CRN09682 for neuroendocrine tumors and other SST2+ tumors, TSH antagonist for Graves’ disease and thyroid eye disease, and SST3 agonist for autosomal dominant polycystic kidney disease.
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.
Planning, including regulatory interactions, for the next study of atumelnant in ACTH-dependent Cushing’s syndrome is underway. Initiation of the Phase 2/3 study 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.
Based on emerging data from IND-enabling studies, our PTH antagonist candidate in preclinical development has been substituted with another candidate expected to exhibit an improved profile. This new candidate is in IND-enabling studies, which we intend to complete next year.
First Quarter 2025 Financial Results
Revenues were $0.4 million for the quarter ended March 31, 2025, compared to $0.6 million for the same period in 2024. Revenues were primarily derived from the paltusotine licensing agreement with Sanwa Kagaku Kenkyusho Co., Ltd.
Research and development expenses were $76.2 million for the three months ended March 31, 2025, compared to $53.3 million for the same period in 2024. The increases were primarily attributable to an increase in personnel costs of $13.3 million, increased manufacturing activities costs of $2.5 million, and increased outside services costs of $4.1 million, for the quarter ended March 31, 2025, respectively, all of which were driven by the advancement of our clinical programs and the expansion of our preclinical portfolio.
Selling, general and administrative expenses were $35.5 million for the three months ended March 31, 2025, compared to $20.8 million for the same period in 2024. The increases were primarily driven by an increase in personnel costs of $7.8 million and an increase in outside services costs of $5.6 million for the quarter ended March 31, 2025, respectively, to support the continued overall growth of the Company and the planned commercial launch of paltusotine.
Net loss for the three months ended March 31, 2025, was $96.8 million, compared to a net loss of $66.9 million for the same period in 2024.
Cash, cash equivalents, and investments totaled $1.3 billion as of March 31, 2025, compared to $1.4 billion as of December 31, 2024. Based on current projections, Crinetics expects that its cash, cash equivalents and investments will be sufficient to fund its current operating plan into 2029. For 2025, we continue to anticipate our cash used in operations to be between $340 and $380 million.
Conference Call and Webcast Details
Management will hold a live conference call and webcast today, Thursday, May 8 at 4:30 p.m. ET. To participate, please dial 1-800-267-6316 (domestic) or 1-203-518-9783 (international) and refer to Conference ID CRNXQ4. To access the webcast, the direct link (here) or visit the Events page of the Crinetics website. Following the live event, the webcast will be archived on the Investor Relations section of www.crinetics.com.