Crinetics Pharmaceuticals Q1 2024 Financial Results and Business Update

Crinetics Pharmaceuticals, Inc., a clinical-stage pharmaceutical company that focuses on developing therapies for endocrine diseases and related tumors, has announced its financial results for the first quarter ending March 31, 2024.

The company began the year strong, building on the positive momentum from its first PATHFNDR readout in 2023. Crinetics' lead investigational compound, paltusotine, has shown promising results from two consecutive late-stage clinical trials in acromegaly and carcinoid syndrome. With the completion of the pivotal PATHFNDR Phase 3 program in acromegaly, the company plans to submit a New Drug Application (NDA) in the second half of 2024. Furthermore, Crinetics intends to discuss the positive results from its Phase 2 study in carcinoid syndrome with the FDA, in preparation for a Phase 3 program expected to start by the end of the year.

Additionally, Crinetics continues to enroll patients in the clinical trials for its second compound, atumelnant, which targets the treatment of congenital adrenal hyperplasia (CAH) and Cushing's disease. Initial results from these trials are anticipated to be reported in the second quarter.

In the first quarter, Crinetics strengthened its financial position with a $350 million private placement financing. This funding supports the company's preparation for the potential commercial launch of paltusotine for acromegaly and the development of its extensive clinical and preclinical pipeline. The company believes this progress positions it for long-term success and moves it closer to its goal of becoming a fully integrated pharmaceutical company.

Key highlights from the first quarter of 2024 include the success of the Phase 3 PATHFNDR-2 study, which met its primary and all secondary endpoints. This placebo-controlled study of paltusotine in participants with acromegaly who were not pharmacologically treated showed positive topline results. Additionally, the Phase 2 study of paltusotine in carcinoid syndrome reported positive results, demonstrating significant reductions in the frequency and severity of flushing episodes and bowel movements.

Financially, Crinetics reported an increase in research and development expenses to $53.3 million for the three months ending March 31, 2024, compared to $38.5 million for the same period in 2023. This increase was mainly due to higher personnel costs, increased spending on manufacturing, and development activities. General and administrative expenses rose to $20.8 million, up from $12.2 million in the same period last year, again primarily driven by higher personnel costs.

The net loss for the first quarter was $66.9 million, compared to a net loss of $46.0 million in the same period of 2023. Revenues were $0.6 million, down from $2.7 million in the previous year, attributed to licensing arrangements for Crinetics' product candidates. As of March 31, 2024, the company had $901.0 million in unrestricted cash, cash equivalents, and investments, significantly up from $558.6 million at the end of December 2023.

Key milestones expected in the near future include the presentation of initial results from the ongoing Phase 2 studies of atumelnant in CAH and ACTH-dependent Cushing’s syndrome at the Endocrine Society’s annual meeting, ENDO 2024, in June. The submission of an NDA for paltusotine for acromegaly is anticipated in the second half of 2024, with the initiation of a Phase 3 study for paltusotine in carcinoid syndrome expected by the end of the year, pending FDA discussions.

Crinetics remains committed to its mission of discovering and developing novel therapeutics for endocrine diseases and endocrine-related tumors. With its lead investigational compounds showing promising results, the company is poised for significant advancements and growth in the upcoming years.