Crinetics Pharmaceuticals(US:CRNX)2025-11-06 21:25Product Development and Approvals - PALSONIFY™ (paltusotine) was approved by the FDA on September 25, 2025, for the treatment of acromegaly, with a marketing authorization application under review by the EMA[88][89]. - Approximately 36,000 people in the U.S. are living with acromegaly, with 17,000 undiagnosed and 11,500 actively managed; 40% of actively managed patients are treatment naïve[88]. - Atumelnant showed significant clinical improvements in a Phase 2 study for congenital adrenal hyperplasia, with data expected early in 2026[92]. - The company expects to initiate a Phase 2/3 trial of atumelnant for ACTH-Dependent Cushing's Syndrome in the first half of 2026[92]. - The first patient for CRN09682, a candidate for treating neuroendocrine tumors, is expected to be enrolled in a Phase 1/2 study in Q4 2025[92]. Financial Performance - The company has not generated any product revenue during the quarter ended September 30, 2025, despite FDA approval of PALSONIFY[95][96]. - Revenues for the nine months ended September 30, 2025, were derived from licensing agreements, with no revenues from PALSONIFY sales[100]. - Revenues for the three months ended September 30, 2025, were $143,000, a 100% increase from $0 in the same period of 2024; revenues for the nine months ended September 30, 2025, were $1,535,000, a 48% increase from $1,039,000 in 2024[107]. Operating Expenses - Cumulative net losses have been incurred since inception, with expectations of increased operating expenses as product revenues grow[96]. - Research and development expenses primarily relate to the clinical development of paltusotine and atumelnant, with significant costs expected to continue[101]. - Research and development expenses increased by $28.6 million (46%) for the three months ended September 30, 2025, and by $73.4 million (42%) for the nine months ended September 30, 2025, compared to the prior year periods[108]. - Selling, general and administrative expenses rose by $26.4 million (102%) for the three months ended September 30, 2025, and by $66.1 million (92%) for the nine months ended September 30, 2025, compared to the prior year periods[112]. - The total operating expenses for the three months ended September 30, 2025, were $142.7 million, a 63% increase from $87.8 million in the same period of 2024; for the nine months ended September 30, 2025, total operating expenses were $384.6 million, a 57% increase from $245.1 million in 2024[107]. - Clinical trial expenses increased by $7.2 million (71%) for the three months ended September 30, 2025, and by $14.5 million (49%) for the nine months ended September 30, 2025, compared to the prior year periods[110]. - Contract manufacturing expenses rose by $3.0 million (43%) for the three months ended September 30, 2025, and by $7.2 million (38%) for the nine months ended September 30, 2025, compared to the prior year periods[110]. Net Loss and Cash Flow - The net loss for the three months ended September 30, 2025, was $130.1 million, a 69% increase from $76.8 million in the same period of 2024; for the nine months ended September 30, 2025, the net loss was $342.5 million, a 57% increase from $217.8 million in 2024[107]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $285.0 million, a 75% increase from $163.3 million in the same period of 2024[120]. - Net cash provided by investing activities increased significantly to $116.8 million for the nine months ended September 30, 2025, compared to a cash outflow of $32.7 million in 2024[120]. - Net cash provided by financing activities decreased by 97% to $14.6 million for the nine months ended September 30, 2025, down from $458.4 million in 2024[120]. Capital and Financing - The company plans to finance cash needs through equity offerings and collaborations until significant product revenues are generated[97]. - The company may need to raise substantial additional capital in the future to support ongoing and future product development[103]. - The company anticipates financing cash needs through equity offerings, debt financings, or collaborations, which may dilute existing stockholder interests[117]. - The company has entered into a Sales Agreement for an ATM Offering of up to $350.0 million, but no shares have been sold under this agreement as of the report date[118]. Cash and Investment Securities - As of September 30, 2025, cash and cash equivalents decreased by 58% to $110.9 million compared to $264.5 million as of December 31, 2024[115]. - Investment securities decreased by 10% to $981.4 million as of September 30, 2025, down from $1.1 billion as of December 31, 2024[115]. - The accumulated deficit increased by 36% to $1.3 billion as of September 30, 2025, compared to $952.1 million as of December 31, 2024[115]. Shareholder Information - As of October 28, 2025, the company had 94.9 million outstanding shares of common stock[119].