Core Insights - Crinetics Pharmaceuticals is preparing for the commercial launch of paltusotine for acromegaly, with a PDUFA date set for September 25, 2025, and plans to initiate four late-stage trials in 2025 [1][9] - The company reported a strong financial position with $1.4 billion in cash, expected to support operations into 2029 [4][12] - Leadership changes have been made to strengthen the organization ahead of the product launch, including the appointment of a new Chief Financial Officer [2][3] Financial Performance - For the full year 2024, Crinetics reported a net loss of $298.4 million, compared to a net loss of $214.5 million in 2023 [6][13] - Revenues for 2024 were $1.0 million, down from $4.0 million in 2023, primarily from a licensing agreement for paltusotine [9][13] - Research and development expenses increased to $240.2 million in 2024 from $168.5 million in 2023, driven by higher personnel costs and increased clinical activities [9][13] Clinical Development and Regulatory Updates - The NDA for paltusotine was accepted by the FDA, based on positive results from the PATHFNDR trials [3][9] - The European Medicines Agency granted paltusotine Orphan Drug Designation for acromegaly, highlighting its potential impact [3] - Positive results were reported from Phase 2 studies of paltusotine in carcinoid syndrome and atumelnant in congenital adrenal hyperplasia [3][9] Upcoming Milestones - Enrollment for pivotal Phase 3 trials of paltusotine in carcinoid syndrome is expected to begin in Q2 2025 [9] - Crinetics plans to initiate four new IND filings in 2025 for development candidates identified in 2024 [9]

Core Points - Crinetics Pharmaceuticals has appointed Tobin "Toby" Schilke as the new Chief Financial Officer, effective February 28, 2025, bringing over 25 years of global pharmaceutical experience [1][2] - The company is in a transformational stage, preparing for its first commercial launch and advancing multiple promising candidates through development [2] - Mr. Schilke's previous experience includes serving as CFO at Revance Therapeutics, where he oversaw finance and operations, supporting two product launches and generating over $700 million in cumulative revenue [2] - The company plans to grant Mr. Schilke 52,000 restricted stock units and a stock option to purchase 80,000 shares, with vesting schedules tied to continued employment [3] - Crinetics Pharmaceuticals focuses on developing novel therapeutics for endocrine diseases, with lead candidate paltusotine in clinical development for acromegaly and carcinoid syndrome [4] Company Overview - Crinetics Pharmaceuticals is a clinical-stage pharmaceutical company dedicated to discovering, developing, and commercializing therapeutics for endocrine diseases and related tumors [4] - The company's lead development candidate, paltusotine, is the first investigational oral selective somatostatin receptor type 2 nonpeptide agonist [4] - 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 [4]

SAN DIEGO, Feb. 20, 2025 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), today announced that company management will participate in two upcoming investment bank conferences. The TD Cowen 45th Annual Healthcare Conference is being held in Boston, MA, and the Leerink Global Healthcare Conference is taking place in Miami, FL. TD Cowen 45th Annual Healthcare Conference Fireside chat on Monday, March 3, 2025 at 11:10 a.m. Eastern Time Webcast link HERE Leerink Global Healthcare Conference F ...

Group 1: Stock Option and RSU Awards - Crinetics Pharmaceuticals granted non-qualified stock option awards to purchase 105,100 shares and 9,950 restricted stock unit (RSU) awards to 14 new non-executive employees under the 2021 Employment Inducement Incentive Award Plan [1][2] - The stock options have an exercise price of $36.53 per share, equal to the closing price on February 10, 2025, and will vest over four years [2] - RSUs will also vest over four years in equal annual installments, starting on the one-year anniversary of the applicable vesting commencement date [2] Group 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 in clinical development for acromegaly and carcinoid syndrome associated with neuroendocrine tumors [3] - The company is also developing atumelnant, an oral ACTH antagonist for congenital adrenal hyperplasia and Cushing's disease, along with other drug candidates targeting various endocrine conditions [3]

Company Overview - Crinetics Pharmaceuticals is a clinical stage pharmaceutical company focused on discovering, developing, and commercializing novel therapeutics for endocrine diseases and endocrine-related tumors [4] - The company's lead development candidate, paltusotine, is the first investigational once-daily, oral, selective somatostatin receptor type 2 (SST2) nonpeptide agonist in clinical development for acromegaly and carcinoid syndrome associated with neuroendocrine tumors [4] - Atumelnant is currently in development for congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome [4] - All drug candidates are orally delivered, small molecule, new chemical entities resulting from in-house drug discovery efforts, addressing various endocrine conditions such as hyperparathyroidism, polycystic kidney disease, Graves' disease, diabetes, obesity, and GPCR-targeted oncology indications [4] Upcoming Financial Results - Crinetics Pharmaceuticals will report its fourth quarter and full year 2024 financial results on February 27, 2025, after the market closes [1] - Company management will host a conference call at 4:30 p.m. ET to discuss financial results and provide a business update [1] Conference Call Details - The conference call can be accessed via domestic dial-in number 1-800-267-6316 or international dial-in number 1-203-518-9783, with Conference ID: CRNXQ4 [2] - Participants are recommended to connect at least 15 minutes prior to the scheduled start of the call to ensure a timely connection [2] - The webcast will be archived on the Investor Relations section of the Crinetics website [3]

SAN DIEGO, Jan. 10, 2025 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that on January 10, 2025, the Compensation Committee of the Board of Directors granted non-qualified stock option awards to purchase an aggregate of 96,100 shares of its common stock to sixteen new non-executive employees and 100,000 to one new executive employee under the Crinetics Pharmaceuticals, Inc. 2021 Employment Inducement Incentive Award Plan (the “2021 Inducement Plan”). The stock options we ...

Clinical Trial Results - Substantial, rapid, and sustained statistically significant reductions in key biomarkers, including up to 80% mean reduction of androstenedione (A4), were achieved across doses [1] - Meaningful improvements demonstrated in multiple clinical signs and symptoms of congenital adrenal hyperplasia (CAH) affecting patient health [1] - Safety and efficacy data support the initiation of a Phase 3 clinical trial [1] Phase 2 TouCAHn Trial Highlights - The TouCAHn trial is an open-label, global, Phase 2 study evaluating the efficacy, safety, and pharmacokinetics of atumelnant in 28 patients with CAH caused by 21-hydroxylase deficiency [3] - Primary endpoints included change from baseline in morning serum androstenedione (A4) levels and incidence of treatment-emergent adverse events [4] - Secondary endpoint evaluated change from baseline in morning serum 17-hydroxyprogesterone (17-OHP) [4] Atumelnant Efficacy Data - Rapid, substantial, and sustained statistically significant reductions in A4 levels were observed across all doses: 40 mg (-619 ng/dL, p=0.0003), 80 mg (-774 ng/dL, p<0.0001), and 120 mg (-954 ng/dL, p<0.0001) [7] - Significant reductions in 17-OHP, a confirmatory secondary biomarker, were also achieved across doses [7] - Substantial reduction and normalization of testosterone in the majority of female participants (8/13), with 6 of the 11 impacted participants resuming menses [14] - Consistent reduction in total adrenal volume observed across dose cohorts [14] - Resolution of androgen-mediated polycythemia in 5 of the 6 impacted participants [14] Safety Profile - Atumelnant has been generally well tolerated with no treatment-related severe or serious adverse events to date [8] - No participants required dose reduction or discontinued from the trial [8] - All adverse events to-date have been mild to moderate and generally transient [8] - The most common treatment-emergent adverse events included headache (7/28) and fatigue (5/28) [8] Company Strategy and Pipeline - Crinetics Pharmaceuticals is advancing atumelnant into a global Phase 3 pivotal trial for adults with CAH and preparing to start a Phase 2b/3 trial in pediatric patients this year [2] - The company's internally discovered pipeline now has two drug candidates with positive later-stage data [2] - Crinetics plans to submit INDs for four additional candidates currently in first-in-human enabling studies [2] - The company aims to build the premier global endocrine company [2] About Atumelnant - Atumelnant is the first once-daily, oral adrenocorticotropic hormone (ACTH) receptor antagonist that acts selectively at the melanocortin type 2 receptor (MC2R) on the adrenal gland [10] - It is currently in development for congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome [10] - Atumelnant has exhibited strong binding affinity for MC2R in preclinical models and demonstrated suppression of adrenally derived glucocorticoids and androgens [10] About Crinetics Pharmaceuticals - Crinetics Pharmaceuticals is a clinical-stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors [12] - The company's lead development candidate, paltusotine, is in clinical development for acromegaly and carcinoid syndrome associated with neuroendocrine tumors [12] - All of the company's drug candidates are orally delivered, small molecule, new chemical entities resulting from in-house drug discovery efforts [12]

SAN DIEGO, Jan. 06, 2025 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics, will present at the 43rd Annual J.P. Morgan Healthcare Conference being held in San Francisco, CA on Tuesday, January 14, 2025 at 4:30 p.m. Pacific Time. To access the live webcast, click here. The archived webcast will also be accessible on the Events & Presentations page in the Investors section of the Crinetics’ website ...

SAN DIEGO, Dec. 16, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced the appointment of Isabel Kalofonos as Chief Commercial Officer. Ms. Kalofonos will lead the company’s commercial strategy and operations for the potential launch of paltusotine, the first and only once-daily, oral, selective somatostatin receptor type 2 nonpeptide agonist for adults living with acromegaly and will lead pre-commercialization activities for the company’s deep, innovative pipeline of ca ...

Novel Nonpeptide Drug Conjugate Platform to be Debuted, Featuring Preclinical Profile of Lead Candidate CRN09682 Targeting SST2-Expressing Tumors, which is on Track for IND Submission Early 2025 Data From Phase 2 Trial of Paltusotine in Carcinoid Syndrome to be Highlighted in Crinetics Symposium and Two Presentations SAN DIEGO, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced two abstracts from its transformative, in-house discovery and development programs w ...