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]

Long-term efficacy and safety data on PALSONIFYTM (paltusotine) in acromegaly to be presented, including evidence of both biochemical and symptom control with a well-tolerated safety profile in patients switching treatments and those not previously pharmacologically treated Atumelnant Phase 2 trial results in congenital adrenal hyperplasia (CAH) to be featured in oral presentation Data from early-stage development program in Graves’ hyperthyroidism and orbitopathy also to be featured SAN DIEGO, June 30, 2 ...

Crinetics Pharmaceuticals (CRNX) 2025 Update / Briefing June 26, 2025 09:00 AM ET Speaker0 Good morning, everyone. Welcome to Kinetics First R and D Day. For those of you joining us in person, I'm so glad the weather calmed down a little bit so you're not sweltering on your way here. And for those of you joining virtually, welcome you to the webcast. So we'll be making forward looking statements today. So I'll pause for a few seconds on the slide for you to absorb all of the fine print. Let's see. So now th ...

SAN DIEGO, June 10, 2025 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that on June 10, 2025, the Compensation Committee of the Board of Directors granted non-qualified stock option awards to purchase an aggregate of 74,000 shares of its common stock and granted an aggregate of 48,850 restricted stock unit (“RSU”) awards to 20 new non-executive employees, in each case, under the Crinetics Pharmaceuticals, Inc. 2021 Employment Inducement Incentive Award Plan (the “2021 In ...

SAN DIEGO, June 10, 2025 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that on June 10, 2025, the Compensation Committee of the Board of Directors granted non-qualified stock option awards to purchase an aggregate of 74,000 shares of its common stock and granted an aggregate of 48,850 restricted stock unit (“RSU”) awards to 20 new non-executive employees, in each case, under the Crinetics Pharmaceuticals, Inc. 2021 Employment Inducement Incentive Award Plan (the “2021 In ...

Company Participation - Crinetics Pharmaceuticals will participate in the Jefferies Global Healthcare Conference from June 3-5, 2025 in New York, NY [1][2] Company Presentation Details - The company presentation is scheduled for Thursday, June 5, 2025, at 12:50 p.m. Eastern Time [2] Company Overview - Crinetics Pharmaceuticals is a clinical stage pharmaceutical company focused on developing novel therapeutics for endocrine diseases and related tumors [3] - The lead candidate, paltusotine, is an investigational once-daily, oral, selective somatostatin receptor type 2 (SST2) nonpeptide agonist, currently in clinical development for acromegaly and carcinoid syndrome associated with neuroendocrine tumors [3] - Atumelnant is in development for congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome [3] - All drug candidates are orally delivered, small molecule, new chemical entities resulting from in-house drug discovery efforts, targeting various endocrine conditions [3]

Core Insights - Crinetics Pharmaceuticals is presenting two abstracts at the AACE Annual Meeting 2025, highlighting the investigational candidate paltusotine's rapid and durable treatment effects in acromegaly patients and the significant symptom burden experienced by patients on standard treatments [1][2][3] Group 1: Paltusotine Development - Paltusotine is a once-daily oral medication that has shown promising results in controlling IGF-1 levels in surgically naïve acromegaly patients, with three out of four patients in one trial achieving IGF-1 normalization [4][10] - The company is preparing for a PDUFA action date of September 25 in the U.S., indicating potential regulatory approval for paltusotine [3][10] - Paltusotine is positioned as a viable first-line therapy for patients who cannot undergo surgery, with sustained IGF-1 control observed over 24 months in clinical trials [4][10] Group 2: Symptom Burden and Treatment Discontinuation - A study revealed that patients on long-acting injectable somatostatin analogs reported symptom exacerbations on 32% of days, leading to reduced quality of life and increased healthcare utilization [5][7] - A retrospective analysis indicated that 54% of acromegaly patients discontinued therapy, with only 20% remaining on their initial treatment, highlighting dissatisfaction with current injectable therapies [7] - The findings underscore the need for more effective treatments that provide consistent symptom control for acromegaly patients [5][7] Group 3: Atumelnant Development - Atumelnant, another investigational compound by Crinetics, is in development for ACTH-dependent Cushing's syndrome and has shown promising results in a Phase 2a study [11] - The compound is designed to selectively target the melanocortin type 2 receptor, potentially offering significant treatment benefits for patients with conditions related to excess ACTH [11]

Core Insights - Crinetics Pharmaceuticals is on track for the FDA review of paltusotine, with a PDUFA date set for September 25, 2025, for the treatment of acromegaly [5][6] - The company is initiating a Phase 3 study for atumelnant aimed at normalizing androstenedione levels in adults with congenital adrenal hyperplasia (CAH) [3][6] - Crinetics has a strong financial position with $1.3 billion in cash and equivalents as of March 31, 2025, expected to fund operations into 2029 [10][14] Regulatory and Clinical Developments - The FDA review process for paltusotine's New Drug Application (NDA) is progressing positively, with consistent engagement from the FDA [6] - The European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for paltusotine, with a potential decision expected in the first half of 2026 [6] - The Phase 2 TouCAHn study of atumelnant in CAH has shown positive results, leading to the initiation of a Phase 3 CALM-CAH study [6][10] Financial Performance - Revenues for the first quarter of 2025 were $0.4 million, down from $0.6 million in the same period of 2024, primarily from a licensing agreement for paltusotine [10][14] - Research and development expenses increased to $76.2 million in Q1 2025 from $53.3 million in Q1 2024, driven by clinical program advancements [10][14] - The net loss for Q1 2025 was $96.8 million, compared to a net loss of $66.9 million in Q1 2024 [10][14] Upcoming Milestones - R&D Day is scheduled for June 26, 2025, to discuss early-stage pipeline strategies and data [3][10] - The company plans to initiate the CAREFNDR Phase 3 trial of paltusotine in carcinoid syndrome in the second half of 2025 [10] - Initiation of the CALM-CAH Phase 3 study in adults and a Phase 2/3 study in pediatrics is expected in the second half of 2025 [10]

SAN DIEGO, April 10, 2025 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that on April 10, 2025, the Compensation Committee of the Board of Directors granted non-qualified stock option awards to purchase an aggregate of 124,950 shares of its common stock and granted an aggregate of 84,725 restricted stock unit (“RSU”) awards to 26 new non-executive employees, in each case, under the Crinetics Pharmaceuticals, Inc. 2021 Employment Inducement Incentive Award Plan (the “2021 ...