Product Development - The company is focused on developing oral nonpeptide therapeutics targeting peptide GPCRs for endocrine diseases, with a lead product candidate, paltusotine, in clinical development for acromegaly and carcinoid syndrome [19]. - Atumelnant, another product candidate, is in development for congenital adrenal hyperplasia (CAH) and ACTH-dependent Cushing's syndrome, with positive Phase 1 data showing dose-dependent reductions in cortisol levels [30]. - The company is also developing CRN09682, a nonpeptide drug conjugate for SST2 positive solid tumors, with plans to file an Investigational New Drug (IND) application in early 2025 [34]. - The company is developing nonpeptide PTH antagonists for the treatment of primary hyperparathyroidism (PHPT) and humoral hypercalcemia of malignancy (HHM), with an estimated 200,000 cases of PHPT in the U.S. [35]. - The company is also developing TSHR antagonists for Graves' disease and Thyroid Eye Disease (TED), which affects approximately 1 in 100 people in the U.S. and 2-3% of the global population [36]. - The company is advancing a selective SST3 nonpeptide agonist for Autosomal Dominant Polycystic Kidney Disease (ADPKD), which affects over 300,000 individuals in the U.S. [37][38]. - The company aims to leverage its expertise in drug discovery to address unmet medical needs in endocrine diseases and related tumors, focusing on innovative nonpeptide drug candidates [39][40]. Clinical Trials and Regulatory Approvals - Paltusotine has shown positive topline data in the PATHFNDR-1 and PATHFNDR-2 trials, achieving primary endpoints with statistical significance (p<0.0001) and demonstrating good tolerability [23][24]. - The FDA has accepted the New Drug Application (NDA) for paltusotine, with a Prescription Drug User Fee Act (PDUFA) Target Action Date set for September 25, 2025 [25]. - The company plans to initiate a Phase 3 program for atumelnant in adult CAH patients in the first half of 2025 and a Phase 2b/3 pediatric program in the second half of 2025 [31]. - The company plans to file an IND application for PTH antagonists in 2025, having selected a development candidate that showed drug-like properties in preclinical models [35]. - An IND application for TSHR antagonists is also planned for 2025, with a development candidate identified that demonstrates good drug-like properties [36]. - The ongoing CAREFNDR Phase 3 trial for carcinoid syndrome aims to measure the percentage change in flushing episodes at week 12 [83]. - The company plans to file a Marketing Authorization Application (MAA) with the EMA in the first half of 2025 [57]. Market and Competition - Approximately 27,000 people in the U.S. are diagnosed with acromegaly, with about 11,000 candidates for chronic pharmacological intervention [20]. - There are an estimated 27,000 patients with classic CAH in the U.S., with approximately 17,000 potential candidates for treatment with atumelnant [29]. - The company faces competition from entities developing somatostatin agonist products, which could impact its ability to commercialize its products [19]. - Current treatments for acromegaly primarily involve painful injections, highlighting the need for a convenient oral alternative like paltusotine [64]. Financial and Operational Considerations - As of December 31, 2024, the company had an accumulated deficit of $952.1 million, primarily due to research and development expenses and general administrative costs [173]. - The company expects to incur significant commercialization expenses if any product candidates receive regulatory approval, impacting future financial performance [176]. - The company has entered into a Sales Agreement to sell up to $350.0 million of common stock, but there is no assurance of successful sales based on market conditions [178]. - The company believes existing cash and equivalents will fund operations for at least the next 12 months, but future capital requirements may necessitate seeking additional funds sooner than planned [177]. - The company has invested significant financial and management resources to build the infrastructure for the commercialization of paltusotine [109]. Intellectual Property and Compliance - The company has multiple issued patents for paltusotine, estimated to expire in 2037, with additional patents expiring between 2039 and 2044 [100]. - The company is actively protecting its proprietary technology through patent rights and has multiple pending applications in various jurisdictions [99]. - The company must comply with various healthcare fraud and abuse laws, which could result in significant penalties for violations [153]. - The company is subject to evolving privacy and security laws that may complicate compliance efforts and lead to potential penalties [162]. Employee and Organizational Structure - The company had 437 full-time employees as of February 24, 2025, with 100 holding a Ph.D. or M.D. degree [164]. - The company does not have any employees represented by labor unions or covered by collective bargaining agreements, indicating a stable employee relationship [164]. - The company aims to attract, retain, and motivate employees through equity incentive plans, which include stock-based compensation and cash-based performance bonuses [165]. Risks and Uncertainties - The company faces significant uncertainty regarding coverage and reimbursement for its therapeutic product candidates, which could impact sales in the U.S. [145]. - Third-party payors are increasingly challenging the pricing and cost-effectiveness of medical products, which may require the company to conduct expensive studies to demonstrate medical necessity [147]. - Legislative changes, including the Inflation Reduction Act of 2022, may affect the company's pricing strategies and reimbursement processes starting in 2026 [152]. - The company may face challenges in enrolling and retaining patients for clinical trials, particularly for orphan diseases with limited patient pools [195]. - Adverse side effects or unexpected characteristics of product candidates could lead to trial interruptions and affect regulatory approval [198]. Regulatory Environment - The FDA's approval process is lengthy and unpredictable, with only a small percentage of drugs successfully completing the approval process [207]. - The FDA may require additional preclinical studies before allowing clinical trials, leading to further delays and increased costs [189]. - The FDA may grant approval contingent on additional costly clinical trials, which could adversely affect revenue generation [208]. - The company may need to adapt to changing regulations and policies from the FDA and other authorities, which could impact its regulatory compliance and profitability [211].

Financial Performance - Crinetics Pharmaceuticals reported a net loss of $80.6 million for Q4 2024, compared to a net loss of $60.1 million in Q4 2023, and a full-year net loss of $298.4 million versus $214.5 million in 2023[6][14]. - The company had no revenues for Q4 2024, while total revenues for the full year were $1.0 million, down from $4.0 million in 2023, primarily from the paltusotine licensing agreement[6][8][14]. - Research and development expenses increased to $66.6 million for Q4 2024 and $240.2 million for the full year, compared to $45.6 million and $168.5 million in 2023, driven by higher personnel costs and increased clinical activities[6][14]. - Crinetics has strengthened its balance sheet and expects cash used in operations to be between $340 million and $380 million for 2025[8][14]. Cash Position - Crinetics has a strong cash position of $1.4 billion as of December 31, 2024, up from $558.6 million a year earlier, providing a runway into 2029[6][8][14]. Development Pipeline - The company expects to initiate four late-stage trials and additional early-stage trials from its development pipeline in 2025[1][3]. - The company plans to file four novel IND applications in 2025 for development candidates nominated in 2024[5][6]. Regulatory Milestones - The FDA has set a PDUFA target action date of September 25, 2025, for the NDA of paltusotine for the treatment of acromegaly[1][5]. Clinical Results - Positive topline results were reported for the Phase 2 study of atumelnant in congenital adrenal hyperplasia, showing significant reductions in A4 levels[7][14]. Leadership Changes - Crinetics appointed new leadership, including Toby Schilke as Chief Financial Officer and Isabel Kalofonos as Chief Commercial Officer, to strengthen its organization ahead of product launches[4][6].

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]

Company Overview - Crinetics Pharmaceuticals, Inc. 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, currently in clinical development for acromegaly and carcinoid syndrome associated with neuroendocrine tumors [4] - Crinetics is also developing atumelnant, an investigational first-in-class oral ACTH antagonist for the treatment of congenital adrenal hyperplasia and Cushing's disease [4] - All drug candidates are orally delivered, small molecules 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 Events - Company management will participate in the TD Cowen 45th Annual Healthcare Conference in Boston, MA, on March 3, 2025, at 11:10 a.m. Eastern Time [2] - Management will also participate in the Leerink Global Healthcare Conference in Miami, FL, on March 10, 2025, at 4:20 p.m. Eastern Time [2] - Live and archived webcasts of these events will be accessible on the Events & Presentations page of the Crinetics website [2]

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 ...