SAN DIEGO, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that on August 10, 2025, the Compensation Committee of the Board of Directors granted non-qualified stock option awards to purchase an aggregate of 75,850 shares of its common stock and granted an aggregate of 53,400 restricted stock unit (“RSU”) awards to 27 new non-executive employees, in each case, under the Crinetics Pharmaceuticals, Inc. 2021 Employment Inducement Incentive Award Plan (the “2021 ...

Crinetics Pharmaceuticals (CRNX) Q2 2025 Earnings Call August 07, 2025 04:30 PM ET Speaker0Welcome to Kinetics Pharmaceuticals Second Quarter twenty twenty five Financial Results Conference Call. At this time, all participants are in a listen only mode. Following the management's prepared remarks, we will hold a question and answer session. Prepared we question I'd now like to turn the call over to Gayathri DeWalker, Head of Investor Relations. Please go ahead.Speaker1Thank you, operator. Good afternoon, ev ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION For the transition period from to Commission File Number: 001-38583 Crinetics Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Washington, D.C. 20549 FORM 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Delaware 26-3744114 (State or other ju ...

Exhibit 99.1 Crinetics Pharmaceuticals Reports Second Quarter 2025 Financial Results and Provides Business Update Regulatory Interactions and Commercial, Medical and Corporate Preparations On-Track for PALSONIFY™ (paltusotine) New Drug Application with September 25, 2025 PDUFA Date Continued Progress on the Global Development Program for Atumelnant Across Multiple Trials, Including the BALANCE- CAH Phase 2/3 Study for the Treatment of Children with Congenital Adrenal Hyperplasia Expected to Initiate this Ye ...

Core Insights - Crinetics Pharmaceuticals announced new data on PALSONIFY (paltusotine) for acromegaly, highlighting its potential as a next-generation treatment option with a consistent safety profile and durable IGF-1 control [2][9] Group 1: Clinical Data and Results - The PATHFNDR-1 trial showed that 53 out of 58 participants (91%) entered the ongoing open-label extension after a 36-week randomized, placebo-controlled period, with interim analysis data available through Week 96 [3] - In the PATHFNDR-2 trial, 103 of 106 completers (97.2%) transitioned to the ongoing open-label extension after a 24-week randomized controlled period, with efficacy data from 88 patients through Week 84 [5] - Mean IGF-1 levels remained stable at 0.81 ± 0.21 times the upper limit of normal (ULN) at Week 96, demonstrating durable biochemical control [6][7] Group 2: Symptom Control and Patient Outcomes - Patients switching from injected somatostatin receptor ligands (SRLs) to PALSONIFY experienced a significant reduction in symptom exacerbations, from over 30% of days on SRLs to just 6.2% during stable PALSONIFY dosing (p < 0.0001) [8] - A pooled analysis of Acromegaly Symptom Diary (ASD) scores indicated that a greater proportion of patients treated with PALSONIFY reported less symptom burden compared to those on placebo [8] Group 3: Company Overview and Future Prospects - Crinetics Pharmaceuticals is focused on developing novel therapeutics for endocrine diseases, with PALSONIFY being the first investigational once-daily oral SST2 nonpeptide agonist in Phase 3 clinical development for acromegaly and carcinoid syndrome [9][10] - The company is also developing Atumelnant for congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome, with all drug candidates being orally delivered small molecules [10]

Group 1 - Crinetics Pharmaceuticals, Inc. will report its second quarter 2025 financial results on August 7, 2025, after market close [1] - A conference call will be held at 4:30 p.m. ET on the same day to discuss the financial results and provide a business update [1][2] - The conference call can be accessed via dial-in numbers or a live webcast, with a recommendation to connect 15 minutes prior to the start [2] Group 2 - Crinetics Pharmaceuticals is a clinical stage pharmaceutical company focused on developing novel therapeutics for endocrine diseases and related tumors [4] - The lead development candidate, PALSONIFY (paltusotine), is in clinical development for acromegaly and carcinoid syndrome associated with neuroendocrine tumors [4] - Other drug candidates include Atumelnant, which is in development for congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome, with all candidates being orally delivered small molecules [4]

Company Overview and Financial Status - Crinetics has a strong financial position with $1.3 billion in cash, cash equivalents, and investments[31] - The company anticipates its first commercial launch this year and holds IP rights into the 2040s[31] Pipeline Programs and Focus - Crinetics is developing paltusotine, with a PDUFA date in September 2025, for acromegaly[27] - The company is developing CRN12755, a TSHR antagonist, for Graves' Hyperthyroidism and Graves' Orbitopathy (TED), with plans for an IND submission[123] - Crinetics is advancing CRN10329, an SST3 agonist, for Autosomal Dominant Polycystic Kidney Disease (ADPKD), with IND-enabling studies ongoing[150] - The company is developing CRN09682, a nonpeptide drug conjugate (NDC), targeting SST2-expressing tumors, currently in Phase 1/2 study[254] Market and Patient Reach - Graves' Hyperthyroidism affects over 3 million individuals in the US, with a significant portion developing TED[75] - ADPKD affects approximately 145,000 diagnosed patients in the US, with 50% developing end-stage kidney disease[130, 131] - The addressable patient population for Graves' Orbitopathy (TED) is up to approximately 170,000 incident cases[120]

Core Points - Crinetics Pharmaceuticals granted non-qualified stock option awards for 102,350 shares and restricted stock unit (RSU) awards for 77,875 shares to 46 new non-executive employees as part of the 2021 Employment Inducement Incentive Award Plan [1][2] - The stock options have an exercise price of $31.99 per share, equal to the closing price on July 10, 2025, and will vest over four years [2] - Crinetics Pharmaceuticals is focused on developing novel therapeutics for endocrine diseases and related tumors, with lead candidate paltusotine in clinical development for acromegaly and carcinoid syndrome [3] Summary by Category Stock Options and RSUs - The stock options and RSUs were granted as inducements for new employees under the 2021 Inducement Plan, in compliance with Nasdaq Listing Rule 5635(c)(4) [1][2] - Stock options will vest 25% after one year, with the remainder vesting in 36 equal monthly installments, contingent on continued employment [2] - RSUs will vest in equal annual installments over four years, also dependent on continued employment [2] Company Overview - Crinetics Pharmaceuticals is a clinical stage pharmaceutical company specializing in endocrine diseases and tumors [3] - The company’s lead candidate, paltusotine, is the first investigational oral selective somatostatin receptor type 2 nonpeptide agonist [3] - Other drug candidates in development include treatments for congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome, with a focus on orally delivered small molecules [3]

Core Insights - Crinetics Pharmaceuticals is set to present long-term efficacy and safety data for its investigational drug PALSONIFY (paltusotine) in acromegaly, demonstrating both biochemical and symptom control with a well-tolerated safety profile [1][2] - The company will also showcase Phase 2 trial results for atumelnant in congenital adrenal hyperplasia (CAH) and data from early-stage development programs in Graves' hyperthyroidism and orbitopathy at the Endocrine Society's Annual Meeting, ENDO 2025 [1][3] PALSONIFY Presentations - Four abstracts will report results from the PALSONIFY development program, including an oral presentation on long-term efficacy, safety, and symptom control in acromegaly patients switching from injectable somatostatin receptor ligands to once-daily oral PALSONIFY [2][4] - Three poster presentations will cover symptom stability in acromegaly, patient-reported outcomes from PATHFNDR-1 and PATHFNDR-2, and open-label extension data from PATHFNDR-2 [2] Atumelnant Presentations - Three abstracts will focus on atumelnant, including an oral presentation of Phase 2 trial results in CAH, highlighting reductions in adrenal volume and significant decreases in potent 11-oxygenated androgens [3][7] Early-Stage Pipeline - Crinetics will present new data from its early-stage pipeline, including findings related to CRN12755 for Graves' hyperthyroidism and orbitopathy [4][8] Company Overview - Crinetics Pharmaceuticals is a clinical-stage pharmaceutical company focused on developing novel therapeutics for endocrine diseases and related tumors, with PALSONIFY and atumelnant as its lead candidates [11]

Summary of Crinetics Pharmaceuticals (CRNX) 2025 Update / Briefing Company Overview - **Company**: Crinetics Pharmaceuticals (CRNX) - **Focus**: Development of novel therapies for endocrine diseases, particularly targeting underserved patient populations Key Points and Arguments Strategic Focus and Pipeline Development - Crinetics was founded to address the needs of patients with endocrine disorders, emphasizing the importance of understanding patient experiences and needs in drug development [10][12][53] - The company has transitioned from a discovery-focused entity to a development and commercialization company, with a pipeline that includes several promising candidates [22][24] Pipeline Highlights - **Paltusotine**: A first-in-class somatostatin receptor agonist for acromegaly, which has progressed through clinical trials and is currently in the NDA process with a PDUFA date set for September 25 [12][22] - **Atomelanet**: An ACTH receptor antagonist for congenital adrenal hyperplasia (CAH) and Cushing's disease, which entered clinical trials in 2021 [20][22] - **CRN 12,755**: A TSH receptor antagonist in development for Graves' disease, which is expected to address both hyperthyroidism and Graves' orbitopathy [55][70] TSH Receptor Antagonist Program - **Graves' Disease**: Affects approximately 1% of the U.S. population (about 3 million people), with significant symptoms including hyperthyroidism and thyroid eye disease [56][81] - Current treatments have limitations, including risks associated with ablative therapies and adverse effects from antithyroid drugs [60][61] - **CRN 12,755**: Demonstrated efficacy in preclinical models, showing potential to suppress thyroid hormone production and mitigate symptoms of orbitopathy [70][72] Market Opportunity - The addressable patient population for Graves' disease therapies is substantial, with an annual incidence of new diagnoses up to 170,000 and a significant number of patients suffering from moderate to severe orbitopathy [81][82] - The company aims to provide a single oral therapy that effectively treats both hyperthyroidism and orbitopathy without the adverse effects associated with current treatments [77] Future Directions - Upcoming poster presentation at the ENDO conference to share additional data on CRN 12,755 [82] - Progressing through IND enabling activities with plans for a Phase 1 healthy volunteer study to establish safety and pharmacokinetics [82] Other Important Content - Emphasis on the company's culture and commitment to patient engagement, which informs their drug development process [12][53] - The importance of having backup candidates in development to mitigate risks associated with lead compounds [46][50] - The dynamic nature of GPCRs and the complexity of drug discovery, highlighting the challenges and strategies in developing effective therapies [33][36] This summary encapsulates the key points from the Crinetics Pharmaceuticals briefing, focusing on the company's strategic direction, pipeline developments, market opportunities, and future plans.