Crinetics Pharmaceuticals(CRNX) - 2025 Q2 - Quarterly Results

Company Overview and Business Update Crinetics Pharmaceuticals advances PALSONIFY™ regulatory review, progresses atumelnant development, and maintains a strong financial position Executive Summary Crinetics Pharmaceuticals reported Q2 2025 financial results, highlighting significant progress towards becoming a fully-integrated, commercial-stage company - Crinetics is making significant progress towards becoming a fully-integrated, commercial-stage company, with regulatory and commercial preparations for PALSONIFY™ (paltusotine) on track[3] - The New Drug Application (NDA) for PALSONIFY™ (paltusotine) has a PDUFA target action date of September 25, 2025[1] - The company holds $1.2 billion in cash, cash equivalents, and investment securities as of June 30, 2025, anticipated to provide a financial runway into 2029[1] Recent Highlights Recent highlights include the ongoing review of paltusotine's NDA for acromegaly, validation of its Marketing Authorization Application (MAA) by the EMA, and continued progress in the global development program for atumelnant - The review process for paltusotine's New Drug Application (NDA) for acromegaly remains on track with consistent and productive engagement with the FDA[4] - Paltusotine's Marketing Authorization Application (MAA) for acromegaly was validated by the European Medicines Agency (EMA), with a potential decision in the first half of 2026[4] - Enrollment for Cohort 4 of the adult Phase 2 study for atumelnant has been completed, with data expected early in 2026[4] - Crinetics presented eight abstracts from its novel clinical development programs, including paltusotine, atumelnant, and CRN12755, at the Endocrine Society's Annual Meeting, ENDO 2025[7] Key Upcoming Milestones Upcoming milestones include the FDA PDUFA date for paltusotine in September 2025, initiation of multiple Phase 3 trials for paltusotine (carcinoid syndrome) and atumelnant (adult and pediatric CAH) in H2 2025, and the start of a Phase 1/2 study for CRN09682 - FDA PDUFA target action date of September 25, 2025, for paltusotine NDA for the treatment of acromegaly[7] - Crinetics expects to initiate the CAREFNDR Phase 3 trial of paltusotine in carcinoid syndrome in the second half of 2025[7] - 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[7] - Initiation of a Phase 2/3 study for atumelnant in ACTH-dependent Cushing's syndrome is expected in the first half of 2026[7] - Crinetics expects to initiate a Phase 1/2 dose escalation study for CRN09682, the first candidate from the nonpeptide drug conjugate (NDC) platform, for SST2-positive neuroendocrine tumors and other SST2-expressing solid tumors[7] Second Quarter 2025 Financial Results Crinetics reported increased Q2 2025 revenues and higher operating expenses, resulting in a larger net loss, but maintains a strong cash position Financial Performance Overview Crinetics reported increased revenues for Q2 2025, primarily from licensing agreements, but significantly increased operating expenses led to a higher net loss compared to the prior year Revenues (in thousands) | Metric | Q2 2025 | Q2 2024 | YoY Change | | :------------------------ | :--------------------- | :--------------------- | :--------- | | Revenues | $1,031 | $399 | +158.4% | Operating Expenses (in thousands) | Metric | Q2 2025 | Q2 2024 | YoY Change | | :------------------------- | :--------------------- | :--------------------- | :--------- | | Research and development | $80,301 | $58,344 | +37.6% | | Selling, general and administrative | $49,842 | $24,838 | +100.7% | - Increase in R&D expenses was primarily due to a $9.6 million increase in personnel costs and a $7.9 million increase in clinical and manufacturing activities costs, driven by clinical program advancement and preclinical portfolio expansion[7] - Increase in SG&A expenses was primarily driven by a $12.0 million increase in personnel costs (due to headcount increase) and a $10.3 million increase in outside services costs for commercial planning for PALSONIFY™[7] Net Loss (in thousands) | Metric | Q2 2025 | Q2 2024 | YoY Change | | :-------- | :--------------------- | :--------------------- | :--------- | | Net loss | $(115,637) | $(74,055) | +56.1% | Financial Position and Outlook As of June 30, 2025, Crinetics held $1.2 billion in cash, cash equivalents, and investments, projecting these resources will fund operations into 2029, with an updated anticipated cash used in operations for 2025 between $340 million and $370 million Cash, Cash Equivalents and Investments (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :----------------------------------- | :------------ | :---------------- | | Cash, cash equivalents and investments | $1,196,360 | $1,354,069 | - Based on current projections, Crinetics expects its cash, cash equivalents, and investments to be sufficient to fund its current operating plan into 2029[7][8] - For 2025, the company now anticipates cash used in operations to be between $340 million and $370 million[8] Corporate Information This section covers Q2 2025 conference call details, Crinetics Pharmaceuticals' therapeutic focus, and forward-looking statement disclaimers Conference Call and Webcast Details Management hosted a live conference call and webcast on August 7, 2025, at 4:30 p.m. ET to discuss the financial results and business update - Management held a live conference call and webcast on Thursday, August 7, 2025, at 4:30 p.m. ET[9] - Access details for the conference call were 1-833-470-1428 (domestic) or 1-404-975-4839 (international) with Access Code 899803[9] About Crinetics Pharmaceuticals Crinetics Pharmaceuticals is a clinical-stage company focused on discovering, developing, and commercializing novel therapeutics for endocrine diseases and related tumors - Crinetics Pharmaceuticals is a clinical-stage company focused on the discovery, development, and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors[10] - PALSONIFY (paltusotine) is the lead investigational once-daily, oral, selective somatostatin receptor type 2 (SST2) nonpeptide agonist in clinical development for acromegaly and carcinoid syndrome[10] - Atumelnant is currently in development for congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome[10] - The company's pipeline includes additional discovery programs for hyperparathyroidism, polycystic kidney disease, Graves' disease, diabetes, obesity, and GPCR-targeted oncology indications[10] Forward-Looking Statements This section contains a standard disclaimer regarding forward-looking statements, emphasizing that actual results may differ materially from projections due to various risks and uncertainties - The press release contains forward-looking statements regarding clinical development plans, regulatory timelines, commercial launch plans, therapeutic potential, and financial runway[11] - Key risks and uncertainties include potential changes in reported data, regulatory authorities disagreeing with interpretations, inability to obtain/enforce intellectual property rights, geopolitical disruptions, unexpected adverse side effects, dependence on third parties, and the timing/outcome of research and development[11][12] - Readers are cautioned not to place undue reliance on these statements, which speak only as of the date of the press release, and Crinetics does not plan to publicly update or revise them[12] Condensed Consolidated Financial Statement Data This section presents unaudited condensed consolidated financial statements, detailing statements of operations and balance sheet data Statements of Operations Data This section provides the unaudited condensed consolidated statements of operations for the three and six months ended June 30, 2025, and 2024, detailing revenues, operating expenses, loss from operations, other income, and net loss STATEMENTS OF OPERATIONS DATA (in thousands) | STATEMENTS OF OPERATIONS DATA: | Three months ended June 30, | | | Six months ended June 30, | | | :----------------------------- | :-------------------------- | :-- | :-- | :------------------------ | :-- | | | 2025 | | 2024 | 2025 | 2024 | | Revenues | $1,031 | | $399 | $1,392 | $1,039 | | Operating expenses: | | | | | | | Research and development | 80,301 | | 58,344 | 156,541 | 111,685 | | Selling, general and administrative | 49,842 | | 24,838 | 85,368 | 45,666 | | Total operating expenses | 130,143 | | 83,182 | 241,909 | 157,351 | | Loss from operations | (129,112) | | (82,783) | (240,517) | (156,312) | | Total other income, net | 13,475 | | 8,728 | 28,106 | 15,797 | | Loss before equity method investment | (115,637) | | (74,055) | (212,411) | (140,515) | | Loss on equity method investment | — | | — | — | (470) | | Net loss | $(115,637) | | $(74,055) | $(212,411) | $(140,985) | | Net loss per share - basic and diluted | $(1.23) | | $(0.94) | $(2.27) | $(1.86) | | Weighted-average shares - basic and diluted | 93,791 | | 79,008 | 93,448 | 75,690 | Balance Sheet Data This section presents the unaudited condensed consolidated balance sheet data as of June 30, 2025, and December 31, 2024, including cash, cash equivalents and investments, working capital, total assets, total liabilities, accumulated deficit, and total stockholders' equity BALANCE SHEET DATA (in thousands) | BALANCE SHEET DATA: | June 30, 2025 | December 31, 2024 | | :----------------------------- | :------------ | :---------------- | | Cash, cash equivalents and investments | $1,196,360 | $1,354,069 | | Working capital | $1,148,868 | $1,315,704 | | Total assets | $1,289,574 | $1,434,592 | | Total liabilities | $118,048 | $109,787 | | Accumulated deficit | $(1,164,521) | $(952,110) | | Total stockholders' equity | $1,171,526 | $1,324,805 |