On November 7, 2023 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) reported financial results for the third quarter ended September 30, 2023 (Press release, Crinetics Pharmaceuticals, NOV 7, 2023, View Source [SID1234637127]).

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"The resounding success of paltusotine in our PATHFNDR-1 Phase 3 study for acromegaly is a significant step toward fulfilling our strategic vision of building a premier, fully integrated endocrine company that can consistently create pioneering therapies for people around the world," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "We intend to build additional momentum around our investigational compound paltusotine in the next few months. In December, we plan to analyze initial data from approximately half of the study participants in our ongoing Phase 2 study in carcinoid syndrome that should provide a preliminary indication of pharmacokinetic exposure, safety, and efficacy in this important second indication. We anticipate the full Phase 2 dataset from carcinoid to be available in the first half of 2024, and we remain on track to announce Phase 3 data from the PATHFNDR-2 study in the first quarter of 2024. We are enthusiastic about these upcoming key milestones for the paltusotine franchise."

THIRD QUARTER 2023 AND OPERATING HIGHLIGHTS
Phase 3 PATHFNDR-1 study met primary and all secondary endpoints. In September 2023, Crinetics reported positive topline results from its placebo-controlled Phase 3 clinical study of paltusotine in participants with acromegaly switching from standard-of-care injected depot somatostatin analogs which is designed to support an indication for the maintenance of acromegaly treatment. The study met statistical significance (p<0.0001) on the primary endpoint, based on the proportion of participants taking paltusotine (83%) who maintained an insulin-like growth factor 1 (IGF-1) level ≤ 1.0 times the upper limit of normal (xULN) compared to those taking placebo (4%). All secondary endpoints also met statistical significance as compared to placebo: change from baseline in IGF-level (p<0.0001), change from baseline in acromegaly symptoms diary (ASD) total score (p=0.02), and proportion of participants who maintained growth hormone level of <1.0 ng/mL (p=0.0003).
Completed enrollment in paltusotine’s Phase 3 PATHFNDR-2 study. PATHFNDR-2 is a placebo-controlled Phase 3 clinical study of oral paltusotine in participants with acromegaly who are treatment-naïve or not currently receiving medical therapy which is designed to support an indication for the treatment of acromegaly. The study completed enrollment of 112 participants with acromegaly who were either treatment-naïve or untreated for at least four months (Stratum 1: n=82), or who washed out of prior octreotide or lanreotide monotherapy (Stratum 2: n=30). Topline data from the study is expected in the first quarter of 2024.
Hosted Key Opinion Leader (KOL) webinar discussing acromegaly unmet need. In August 2023, Crinetics hosted a webinar featuring presentations by KOLs Beverly MK Biller, M.D. and Karen JP Liebert, R.N., BSN, both of Massachusetts General Hospital, who discussed the current landscape and unmet medical need in acromegaly, as well as the treatment burden associated with standard-of-care injectable somatostatin receptor ligands (SRLs). A replay of the webinar can be accessed here.
Paltusotine NDA submission anticipated in 2024. Pending successful data from the PATHFNDR-2 study, Crinetics plans to submit a new drug application (NDA) to the Food and Drug Administration seeking regulatory approval for both the treatment of acromegaly and maintenance of acromegaly treatment indications.
Initial data from Phase 2 study of paltusotine in carcinoid syndrome expected December 2023. The Phase 2 open-label study of paltusotine in carcinoid syndrome associated with neuroendocrine tumors is completing enrollment. A preliminary analysis from a subset of approximately half of the expected 30 participants is anticipated in December 2023. The study is designed primarily to assess the pharmacokinetic exposure and safety profile of paltusotine in participants with carcinoid syndrome. In addition, the study should provide descriptive efficacy information on the frequency of bowel movements and flushing episodes.
CRN04894 studies for Cushing’s disease and congenital adrenal hyperplasia (CAH). Based on successful Phase 1 studies demonstrating pharmacologic proof-of-concept, Crinetics is advancing clinical studies of CRN04894 in both Cushing’s disease and congenital adrenal hyperplasia. Data from the ongoing studies are expected in the second half of 2024.
Strengthened balance sheet with $350 million public offering. In September 2023, Crinetics announced the pricing of an upsized underwritten public offering of 11,441,648 shares of its common stock at $30.59 per share. Gross proceeds from the offering were $350.0 million.
THIRD QUARTER 2023 FINANCIAL RESULTS
Research and development expenses were $43.8 million for the three months ended September 30, 2023, compared to $32.0 million for the same period in 2022. The change was primarily due to an increase in personnel costs of $8.3 million, increased net spending on manufacturing and development activities of $1.8 million associated with our clinical and nonclinical programs, and increased outside services of $1.2 million.
General and administrative expenses were $15.5 million for the three months ended September 30, 2023, compared to $11.9 million for the same period in 2022. The change was primarily due to an increase in personnel costs of $3.2 million.
Net loss for the three months ended September 30, 2023, was $57.5 million, compared to a net loss of $41.9 million for the same period in 2022.
Revenues were $0.3 million for the three months ended September 30, 2023, compared to $0.5 million for the same period in 2022. Revenues in both periods were primarily derived from the paltusotine licensing arrangement with Sanwa Kagaku Kenkyusho Co., Ltd.
Unrestricted cash, cash equivalents, and investments totaled $554.7 million as of September 30, 2023, compared to $334.4 million as of December 31, 2022. 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 2026.
The company had 66,799,257 common shares outstanding as of October 31, 2023.