On May 9, 2024 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, 2024 (Press release, Crinetics Pharmaceuticals, MAY 9, 2024, View Source [SID1234642986]).

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"Building on the positive momentum from the first PATHFNDR readout in 2023, Crinetics began 2024 with continued strong performance. Our lead investigational compound, paltusotine, delivered positive data from two consecutive late-stage clinical trials in acromegaly and carcinoid syndrome. With our pivotal PATHFNDR Phase 3 program in acromegaly now complete, we are working diligently to submit an NDA in the second half of 2024. We also intend to discuss the positive results from our Phase 2 study in carcinoid syndrome with the FDA in preparation for the Phase 3 program, which is expected to be initiated by the end of this year," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics.

"The clinical trials for the second compound in our pipeline, atumelnant, which is being developed for the treatment of CAH and Cushing’s disease, continue to enroll patients. We plan to report initial results from a subset of patients from these trials in the second quarter," continued Dr. Struthers. "In the first quarter, we strengthened our balance sheet to support commercial readiness for a potential paltusotine launch in acromegaly, as well as to fund the development of our deep clinical and preclinical pipeline. The progress made across our pipeline positions the Company for long-term success and towards achieving our objective to become a fully integrated pharmaceutical company."

First Quarter 2024 and Recent Highlights:

Phase 3 PATHFNDR-2 study achieved primary and all secondary endpoints. In March, Crinetics reported positive topline results from its placebo-controlled Phase 3 study of paltusotine in non-pharmacologically treated participants with acromegaly. PATHFNDR-2 was designed to support a treatment indication in those with uncontrolled acromegaly.
Phase 2 study of paltusotine in carcinoid syndrome reported positive results. In March, Crinetics reported positive topline results from its open-label Phase 2 study of paltusotine in participants with carcinoid syndrome. Paltusotine was shown to result in rapid and sustained reductions in frequency and severity of flushing episodes and bowel movements.
Strengthened balance sheet with $350 million private placement financing. In February, Crinetics announced a private placement equity financing for gross proceeds of approximately $350 million.
Key Upcoming Milestones

Initial results from the ongoing Phase 2 studies of atumelnant* in congenital adrenal hyperplasia (CAH) and ACTH-dependent Cushing’s syndrome will be presented at the Endocrine Society’s annual meeting, ENDO 2024, being held June 1-4, 2024 in Boston. The Phase 2 studies are evaluating the safety, efficacy and pharmacokinetics of different doses of atumelnant in participants with CAH and Cushing’s disease.
Submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking regulatory approval of paltusotine for the treatment of acromegaly is anticipated in the second half of 2024.
Initiation of a Phase 3 program of paltusotine for carcinoid syndrome by the end of 2024, pending discussions with the FDA.
First Quarter 2024 Financial Results

Research and development expenses were $53.3 million for the three months ended March 31, 2024, compared to $38.5 million for the same period in 2023. The increases were primarily attributable to an increase in personnel costs of $9.4 million, increased outside services and facilities costs of $3.8 million, and increased spending on manufacturing and development activities of $1.4 million.
General and administrative expenses were $20.8 million for the three months March 31, 2024, compared to $12.2 million for the same period in 2023. The increases were primarily attributable to an increase in personnel costs of $5.6 million.
Net loss for the three months ended March 31, 2024, was $66.9 million, compared to a net loss of $46.0 million for the same period in 2023.Revenues were $0.6 million for the three months ended March 31, 2024, compared to $2.7 million for the same period in 2023.
Revenues were derived from licensing arrangements for our paltusotine product candidate in 2024 and for paltusotine and CRN01941 product candidates in 2023.
Unrestricted cash, cash equivalents, and investments totaled $901.0 million as of March 31, 2024, compared to $558.6 million as of December 31, 2023. On February 28, 2024, the company announced a private placement equity financing for gross proceeds of approximately $350 million. Based on its current projections, the company now expects that its cash, cash equivalents and short-term investments will be sufficient to fund its current operating plan into 2028.
*Proposed international nonproprietary name under review.

Conference Call and Webcast Details
Management will hold a live conference call and webcast today, Thursday, May 9, 2024 at 4:30 p.m. ET. To participate, please dial 1-888-886-7786 (domestic) or 1-416-764-8658 (international) and refer to Conference ID 71864759. To access the webcast, click here. For instant telephone access, click the Call me link here. Following the live event, a replay will be available on the Investors section of the Company’s website.