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 ...

Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX) Q3 2024 Earnings Conference Call November 12, 2024 4:30 PM ET Company Participants Gayathri Diwakar - Head-Investor Relations Scott Struthers - Founder and Chief Executive Officer Marc Wilson - Chief Financial Officer Dana Pizzuti - Chief Medical and Development Officer Alan Krasner - Chief Endocrinologist Conference Call Participants Cory Jubinville - LifeSci Capital Jessica Fye - J.P. Morgan Jeff Hung - Morgan Stanley Charlie Moore - Baird Dennis Ding - Jeffer ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION 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 September 30, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38583 Crinetics Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 26-3744114 (State or oth ...

Drug Development - Submitted New Drug Application (NDA) for paltusotine for the treatment of acromegaly, with FDA notification expected in December 2024[3] - The company has four new drug candidates currently in IND-enabling studies, with plans for clinical development in 2025[4] - Anticipates additional data from the Phase 2 study of atumelnant in congenital adrenal hyperplasia (CAH) by early 2025[4] - Plans to finalize a Phase 3 protocol and initiate site startup activities for paltusotine in carcinoid syndrome by the end of 2024[4] - The first-in-human enabling studies for a TSH antagonist candidate have commenced, with an IND filing expected in 2025[3] Financial Performance - Completed an upsized public offering of common stock for gross proceeds of $575 million, strengthening the company's balance sheet[3] - Research and development expenses increased to $61.9 million for Q3 2024, up from $43.8 million in Q3 2023, primarily due to higher personnel and manufacturing costs[5] - General and administrative expenses rose to $25.9 million for Q3 2024, compared to $15.5 million for the same period in 2023, driven by increased personnel and outside services costs[5] - Net loss for Q3 2024 was $76.8 million, compared to a net loss of $57.5 million in Q3 2023[5] - Cash, cash equivalents, and investment securities totaled $862.7 million as of September 30, 2024, compared to $558.6 million as of December 31, 2023[5]

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. 12, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced two abstracts from its transformative, in-house discovery and development programs w ...

Submission of New Drug Application for Paltusotine for the Treatment of Acromegaly Completed Upsized Public Offering of $575M of Common Stock Debut of First Drug Candidate from a Novel Nonpeptide Drug Conjugate Platform at North American Neuroendocrine Tumor Society (NANETS) Total of Four New Drug Candidates in IND-Enabling Preclinical Studies Management Hosting Conference Call at 4:30 p.m. ET Today SAN DIEGO, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stag ...

SAN DIEGO, Oct. 08, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, announced today the pricing of an upsized underwritten public offering of 10,000,000 shares of its common stock at a price to the public of $50.00 per share. All of the shares to be sold in the offering are to be sold by Crinetics. The gross pr ...