On May 4, 2023 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), (Nasdaq: CRNX) reported financial results for the first quarter ended March 31, 2023 (Press release, Crinetics Pharmaceuticals, MAY 4, 2023, View Source [SID1234631025]).

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"We plan to share topline results from PATHFNDR-1 next quarter, which should provide an important look at the impact that paltusotine may have on patients’ lives," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "We designed the two PATHFNDR studies to address both treatment-naïve patients as well as patients who may switch from standard of care, the two patient populations specifically outlined in the recently released draft guidance from the FDA on Developing Drugs for Acromegaly Treatment."

Dr. Struthers continued, "Enrollment in PATHFNDR-2 has benefited from enthusiastic participation of treatment-naïve patients. This enables us to take advantage of a prespecified opportunity to increase the study’s enrollment target while maintaining our estimated timeline of topline data in the first quarter of 2024. We anticipate this will provide an even clearer picture of paltusotine’s potential to treat patients who have been recently diagnosed with acromegaly and could strengthen the competitive position of paltusotine from a market and payer perspective, if approved."

CLINICAL PROGRAM UPDATES:
Paltusotine’s Phase 3 PATHFNDR-1 study: enrollment complete with topline data expected in 3Q 2023. PATHFNDR-1 is a placebo-controlled Phase 3 clinical study of once-daily, oral paltusotine in participants with acromegaly switching from standard-of-care peptide depots. It is designed to support an indication for the maintenance of acromegaly treatment. The study enrolled participants with acromegaly who were biochemically controlled (IGF-1 ≤ 1.0x upper limit of normal) on octreotide or lanreotide depot monotherapy. The primary endpoint of the study is the proportion of participants who maintain biochemical control on paltusotine vs. placebo. Final study enrollment is 58 participants with topline data expected in the third quarter of 2023.
Paltusotine’s Phase 3 PATHFNDR-2 study: enrollment ongoing with enrollment target increased to up to 98; topline data expected in 1Q 2024. PATHFNDR-2 is a placebo-controlled Phase 3 clinical study designed to support an indication for the treatment of acromegaly. The study is enrolling participants with acromegaly with elevated IGF-1 levels who are either treatment-naïve or untreated for at least four months (Stratum 1), or who wash out of prior octreotide or lanreotide therapy (Stratum 2). The current enrollment has included a higher enrollment of participants in Stratum 1 as compared to Stratum 2. Accordingly, Crinetics has elected to adjust PATHFNDR-2’s sample size to enable enrollment of up to 98 participants, which was an option prespecified in the study protocol. In addition to preserving statistical power to detect a difference on the primary endpoint, increasing the study’s sample size may enable a statistical comparison of Stratum 1 participants receiving either paltusotine or placebo. Topline data from the study are expected in the first quarter of 2024, in line with prior guidance.
Paltusotine NDA Submission anticipated in 2024. Pending a successful outcome from the PATHFNDR studies, Crinetics plans to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) seeking regulatory approval for paltusotine in acromegaly with both treatment and maintenance of treatment indications.
Phase 2 open-label study of paltusotine in carcinoid syndrome ongoing. The Phase 2 open-label study of paltusotine in carcinoid syndrome associated with neuroendocrine tumors continues to enroll participants with preliminary data expected in the fourth quarter of 2023.

Advancing CRN04894 studies in Cushing’s disease and congenital adrenal hyperplasia. Based on successful Phase 1 studies demonstrating pharmacologic proof-of-concept, Crinetics is conducting clinical studies of CRN04894 in patients with Cushing’s disease and congenital adrenal hyperplasia. Data from both studies is expected in 2024.

CRN04777 progress. In November 2022, the FDA informed Crinetics that its planned Phase 2 study of CRN04777 in pediatric participants with congenital hyperinsulinism was not yet permitted to proceed. Crinetics plans to submit additional information and data to the FDA to support a release of the clinical hold on the planned Phase 2 study. The planned Phase 2 study is supported by pharmacologic proof-of-concept results from a successful Phase 1 study in healthy adult volunteers conducted under a Clinical Trial Application in Germany.

FIRST QUARTER 2023 FINANCIAL RESULTS

Research and development expenses were $38.5 million for the three months ended March 31, 2023, compared to $28.3 million for the same period in 2022. The increase was primarily attributable to an increase in personnel costs of $7.0 million and increased consulting and outside services of $1.4 million to support paltusotine, CRN04894, CRN04777, and our preclinical programs.

General and administrative expenses were $12.2 million for the three months ended March 31, 2023, compared to $8.7 million for the same period in 2022. The increase was primarily attributable to an increase in personnel costs of $2.7 million and an increase in other corporate expenditures of $0.8 million.
Net loss for the three months ended March 31, 2023 was $46.0 million, compared to a net loss of $34.6 million for the same period in 2022.

Revenues were $2.7 million for the three months ended March 31, 2023, compared to $3.1 million for the same period in 2022. Revenues in both periods were derived from out-licensing arrangements: for CRN01941 in March 2023 and paltusotine in February 2022.

Unrestricted cash, cash equivalents, and investments totaled $296.1 million as of March 31, 2023, compared to $334.4 million as of December 31, 2022. Based on its current projections, the company expects that its cash, cash equivalents and short-term investments will fund its current operating plan through 2024.
The company had 53,994,770 common shares outstanding as of May 1, 2023.