On August 7, 2025 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a global pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, reported financial results for the second quarter ended June 30, 2025 (Press release, Crinetics Pharmaceuticals, AUG 7, 2025, View Source [SID1234654970]).

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"We continue to make significant progress towards our goal of becoming a fully-integrated, commercial-stage company and delivering on our commitment to help people living with acromegaly," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "As we approach our PDUFA date, our interactions with the FDA remain on track. In addition to our world-class drug discovery and development capabilities, we have now nearly completed the build-out of a premier commercial organization. We are committed to rapidly making PALSONIFY available as the new level of care for patients upon approval. At the same time, we remain dedicated to the execution of early- and late-stage trials across our pipeline. I am excited to see the ramp of our late-stage trials in carcinoid syndrome and CAH (both adult and pediatric), as well as initiation of the Phase 1/2 trial of our first nonpeptide drug-conjugate, CRN09682, for SST2-expressing solid tumors. Overall, Crinetics is in the strongest position in its history, with unprecedented momentum across our clinical programs, multiple new candidates approaching the clinic, a solid financial foundation, and a clear path toward delivering transformative therapies to patients."

Second Quarter 2025 and Recent Highlights:

The review process for paltusotine’s New Drug Application (NDA) for acromegaly remains on track with consistent and productive engagement with the Food & Drug Administration (FDA).
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.
Continued progress on the global development program for atumelnant across multiple trials, including enrollment completion of Cohort 4 of the adult Phase 2 study with data expected early in 2026.
The Phase 2/3 BALANCE-CAH pediatric study is seamlessly designed to expedite development with the goal of demonstrating atumelnant’s potential ability to normalize androstenedione (A4) levels with physiological glucocorticoid (GC) replacement.
Presented two abstracts at the American Association of Clinical Endocrinology (AACE) Annual Meeting 2025 which showed treatment with investigational PALSONIFY resulted in rapid and durable IGF-1 control in surgically naïve acromegaly patients and additional research on symptom burden and standard-of-care discontinuation rates.
Eight abstracts from Crinetics’ novel clinical development programs, including oral presentations featuring lead investigational drug candidate, paltusotine, investigational candidate atumelnant, and CRN12755, the early-stage development program in Graves’ hyperthyroidism and orbitopathy, were presented at the Endocrine Society’s Annual Meeting, ENDO 2025.
Key Upcoming Milestones:
FDA PDUFA target action date of September 25, 2025 for paltusotine NDA for the treatment of acromegaly.
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 BALANCE-CAH 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 first half of 2026.
Crinetics expects to initiate a Phase 1/2 dose escalation study for CRN09682, the first candidate from the nonpeptide drug conjugate (NDC) platform with an expansion phase for the treatment of metastatic or locally advanced SST2-positive neuroendocrine tumors (NETs) and other SST2-expressing solid tumors.
IND-enabling activities for the TSH antagonist continue as expected, and development of the SST3 agonist and PTH antagonist is ongoing.
Second Quarter 2025 Financial Results:
Revenues were $1.0 million for the quarter ended June 30, 2025, compared to $0.4 million for the same period in 2024. Revenues were derived from the paltusotine licensing and supply agreements with Sanwa Kagaku Kenkyusho Co., Ltd.

Research and development expenses were $80.3 million for the three months ended June 30, 2025, compared to $58.3 million for the same period in 2024. The increases were primarily attributable to an increase in personnel costs of $9.6 million and increased clinical and manufacturing activities costs of $7.9 million for the quarter ended June 30, 2025, respectively, driven by the advancement of our clinical programs and the expansion of our preclinical portfolio.
Selling, general and administrative expenses were $49.8 million for the three months ended June 30, 2025, compared to $24.8 million for the same period in 2024. The increases were primarily driven by an increase in personnel costs of $12.0 million primarily due to the increase in headcount and an increase in outside services costs of $10.3 million primarily for commercial planning for the quarter ended June 30, 2025, respectively, to support our overall growth and the planned commercial launch of PALSONIFY
Net loss for the three months ended June 30, 2025, was $115.6 million, compared to a net loss of $74.1 million for the same period in 2024.

Cash, cash equivalents, and investments totaled $1.2 billion as of June 30, 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 now anticipate our cash used in operations to be between $340 and $370 million.

Conference Call and Webcast Details

Management will hold a live conference call and webcast today, Thursday, August 7 at 4:30 p.m. ET. To participate, please dial 1-833-470-1428 (domestic) or 1-404-975-4839 (international) and refer to Access Code 899803. 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.