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 ...

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]

Core Viewpoint - Crinetics Pharmaceuticals has granted stock options and restricted stock units to new non-executive employees as part of its 2021 Employment Inducement Incentive Award Plan to attract talent [1][2]. Group 1: Stock Options and RSUs - The Compensation Committee granted a total of 74,000 stock options and 48,850 RSUs to 20 new employees [1]. - The stock options have an exercise price of $33.08 per share, equal to the closing price on June 10, 2025 [2]. - Stock options will vest over four years, with 25% vesting after one year and the remainder vesting in 36 equal monthly installments [2]. Group 2: Company Overview - Crinetics Pharmaceuticals is a clinical stage pharmaceutical company focused on developing therapeutics for endocrine diseases and related tumors [3]. - The lead candidate, paltusotine, is in clinical development for acromegaly and carcinoid syndrome [3]. - Other drug candidates are being developed for conditions such as congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome, with a focus on orally delivered small molecules [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]

Financial Data and Key Metrics Changes - The company recognized $400,000 in revenue during Q1 2025, down from $600,000 in Q1 2024, with revenue being non-cash based on amortization of payments from a licensing arrangement [40] - Research and development (R&D) expenses increased by 43% to $76.2 million in Q1 2025 compared to the same period in 2024, primarily due to additional personnel and higher manufacturing costs [40] - Selling, general, and administrative (SG&A) expenses rose by 71% to $35.5 million in Q1 2025, driven by growth to support ongoing programs and the planned commercial launch of paltusotine [41] - Cash used in operations for Q1 2025 was $88.5 million, compared to $52.9 million in Q1 2024, with expectations of cash used in operations for 2025 between $340 million and $380 million [42] - The company ended Q1 2025 with approximately $1.3 billion in cash, cash equivalents, and investments, expected to fund operations into 2029 [42] Business Line Data and Key Metrics Changes - The company is focused on the anticipated commercial launch of paltusotine, which is expected to significantly improve treatment for patients with acromegaly [8][10] - The pipeline includes two late-stage candidates and three additional candidates in preclinical studies, indicating a robust development strategy [8] Market Data and Key Metrics Changes - The company is preparing for the launch of paltusotine in the U.S. and has engaged with payers, receiving positive feedback regarding the product's value proposition [18][23] - The anticipated launch strategy includes educating healthcare professionals and patients, with a focus on addressing the unmet needs in acromegaly treatment [12][16] Company Strategy and Development Direction - The company aims to become a fully integrated global commercial organization, with a strong commitment to patient care and scientific innovation [8] - The strategic focus includes advancing a robust pipeline while preparing for the commercial launch of paltusotine, which is seen as a pivotal milestone [10][24] - The company is also exploring opportunities in the CAH (congenital adrenal hyperplasia) market with the development of adomelna [34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory engagement with the FDA and the progress of clinical development activities [10][24] - The company remains optimistic about the potential uptake of paltusotine during the early launch phase, anticipating major interest from healthcare providers and patients [23] Other Important Information - The company has welcomed a new CFO, Toby Schulke, who brings extensive experience in transitioning R&D-focused companies into commercial organizations [9] - The company has launched the Kineticare patient support service platform to assist patients throughout their treatment journey [16][17] Q&A Session Summary Question: Can you discuss the powering of your primary endpoint and any data from cohort four? - Management indicated that the study is highly powered to detect significant differences between treatment and placebo groups, and cohort four is currently enrolling with no data available yet [46][48] Question: Is the CALM CAH study design approved by the FDA for registration? - The protocol was developed with input from the FDA, and the company expects to discuss the indication statement based on the data collected [51][54] Question: What is the rationale for testing the primary endpoint at a single time point? - Management explained that responder analyses are typically conducted at single points in time due to variability in biochemical markers, and they are confident in achieving the endpoint [57][58] Question: What is the rationale for morning versus evening dosing in cohort four? - The company aims to explore the convenience of morning dosing while considering the diurnal rhythm of CAH patients [61][62] Question: How is the launch strategy different in Europe compared to the U.S.? - The European markets are more concentrated in terms of patient populations, and the company is preparing for a launch in Germany while considering Brazil for expansion [64][68]

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]