Crinetics Pharmaceuticals Q2 2024 Financial Results and Business Update

Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical-stage pharmaceutical company specializing in novel endocrine therapeutics, has announced its financial results for the second quarter ending June 30, 2024. The firm has made significant strides in its goal to become a leading endocrine-focused pharmaceutical company.

Scott Struthers, Ph.D., the Founder and CEO of Crinetics, emphasized the company’s remarkable progress during the second quarter of 2024. At the ENDO 2024 conference in June, Crinetics demonstrated the extensive capabilities of its pipeline. The company's second internally-developed candidate, atumelnant, exhibited promising initial results for congenital adrenal hyperplasia (CAH) and Cushing’s disease. Additional data from both indications are expected by the end of the year. Data from the paltusotine program also continues to affirm its potential to benefit patients with acromegaly. The company remains on track to submit a New Drug Application (NDA) for paltusotine for acromegaly within 2024, with an anticipated market launch in 2025.

In a significant development, Crinetics also announced the transition of Marc Wilson from his role as Chief Financial Officer for personal reasons. The company has initiated a search for his replacement. Wilson will continue to fully perform his duties until a successor is named, ensuring a smooth transition. Struthers praised Wilson’s invaluable contributions over the past six years, particularly in capital markets activities, corporate affairs, and the overall growth of the organization.

Wilson expressed pride in Crinetics’ achievements and confidence in the company’s financial health and its team’s ability to continue advancing meaningful therapies. He pledged to support the company through the transition period and looked forward to its ongoing success.

Key highlights from the second quarter include:

- Presentation of positive initial results from atumelnant studies at the Endocrine Society’s Annual Meeting (ENDO 2024) in Boston. The studies focused on ACTH-dependent Cushing’s syndrome and congenital adrenal hyperplasia (CAH).

- Data presentations from the paltusotine development program at ENDO 2024. The findings included outcomes from the Phase 3 PATHFNDR-2 trial, a new analysis of patient-reported outcome data from the Phase 3 PATHFNDR-1 trial, and interim long-term efficacy and safety results from the open-label ACROBAT Advance extension study.

- Selection of development candidates in two programs: an oral parathyroid hormone antagonist for hyperparathyroidism and a candidate in the SST3 agonist program for autosomal dominant polycystic kidney disease.

- Strengthening of Crinetics’ scientific leadership team with the appointments of Lise Kjems, M.D., Ph.D., as Senior Vice President of Endocrinology Clinical Research, and Robert M. Cuddihy, M.D., as Senior Vice President of Medical Affairs.

Upcoming milestones include:

- Topline and additional data from Phase 2 studies of atumelnant in CAH and ACTH-dependent Cushing’s syndrome, respectively, expected by the end of 2024.
- The planned NDA submission to the U.S. Food and Drug Administration (FDA) for paltusotine to treat acromegaly remains on track for the latter half of 2024.
- Initiation of a Phase 3 program for paltusotine in carcinoid syndrome is expected by the end of 2024, following FDA consultation.
- Additional updates on the research pipeline are anticipated by the end of the year.

Financially, Crinetics reported research and development expenses of $58.3 million for the three months ended June 30, 2024, up from $40.6 million in the same period in 2023. This increase is largely due to higher personnel costs and intensified manufacturing and development activities. General and administrative expenses rose to $24.8 million from $13.3 million in the same period last year, primarily driven by increased personnel and commercial planning costs. Net loss for the second quarter was $74.1 million, compared to a net loss of $51.0 million in the same period in 2023. Revenues for the three months ended June 30, 2024, were $0.4 million, down from $1.0 million in the same period in 2023, mainly derived from the paltusotine licensing arrangement with Japanese partner Sanwa Kagaku Kenkyusho.

Crinetics' cash, cash equivalents, and investments totaled $863.0 million as of June 30, 2024, compared to $558.6 million as of December 31, 2023. The company projects that its current financial resources will support its operating plans into 2028.