SAN DIEGO, May 23, 2025 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), today announced that company management will participate in the Jefferies Global Healthcare Conference, taking place June 3-5, 2025 in New York, NY. Jefferies Global Healthcare Conference 2025Company presentation: Thursday, June 5, 2025 at 12:50 p.m. Eastern TimeWebcast link: HERE The live and archived webcast will be accessible on the Events & Presentations page in the Investors section of the Crinetics’ website at ...

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]

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 [3] - The company's lead development candidate, paltusotine, is an investigational once-daily, oral, selective somatostatin receptor type 2 (SST2) nonpeptide agonist in clinical development for acromegaly and carcinoid syndrome associated with neuroendocrine tumors [3] - Crinetics is also developing atumelnant, a first-in-class oral ACTH antagonist for treating congenital adrenal hyperplasia and Cushing's disease [3] - All drug candidates are orally delivered, small molecules resulting from in-house drug discovery efforts, targeting various endocrine conditions [3] Recent Developments - On May 10, 2025, the Compensation Committee granted non-qualified stock option awards to purchase an aggregate of 152,475 shares and 101,800 restricted stock unit (RSU) awards to 35 new non-executive employees [1] - The stock options have an exercise price of $30.68 per share, equal to the closing price on May 9, 2025 [2] - The stock options and RSUs are granted under the 2021 Employment Inducement Incentive Award Plan, aimed at attracting new employees [1][2]

Company Performance - Crinetics Pharmaceuticals reported a quarterly loss of $1.04 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.99, and compared to a loss of $0.93 per share a year ago, indicating a decline in performance [1] - The company posted revenues of $0.36 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 261%, but this was a decrease from year-ago revenues of $0.64 million [2] - Over the last four quarters, Crinetics has only surpassed consensus EPS estimates once, indicating inconsistent performance [2] Stock Movement and Outlook - Crinetics Pharmaceuticals shares have declined approximately 38.6% since the beginning of the year, significantly underperforming the S&P 500, which declined by only 4.3% [3] - The company's earnings outlook is uncertain, with current consensus EPS estimates for the upcoming quarter at -$1.10 on revenues of $2.6 million, and for the current fiscal year at -$4.33 on revenues of $5.63 million [7] Industry Context - The Medical - Drugs industry, to which Crinetics belongs, is currently ranked in the top 26% of over 250 Zacks industries, suggesting a relatively strong industry performance [8] - The performance of Crinetics may be influenced by the overall outlook for the industry, as empirical research indicates that the top 50% of Zacks-ranked industries outperform the bottom 50% by more than 2 to 1 [8]

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]

Financial Data and Key Metrics Changes - The company recognized $400,000 in revenue for Q1 2025, down from $600,000 in Q1 2024, with revenue being non-cash based on amortization of licensing payments [39] - Research and development (R&D) expenses increased by 43% to $76.2 million in Q1 2025 compared to the same period in 2024 [39] - Selling, general and administrative (SG&A) expenses rose by 71% to $35.5 million in Q1 2025 compared to Q1 2024 [40] - Cash used in operations was $88.5 million for Q1 2025, compared to $52.9 million in Q1 2024, with an anticipated cash usage of $340 million to $380 million for the full year [41][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 acromegaly [7][10] - The company is advancing a robust pipeline, including two late-stage candidates and three additional candidates in preclinical studies [7][8] Market Data and Key Metrics Changes - The company is preparing for the U.S. launch of paltusotine in September, with significant engagement with healthcare professionals and payers [12][19] - The company anticipates major uptake during the early launch phase as it educates healthcare providers and patient communities about paltusotine [23] Company Strategy and Development Direction - The company aims to become a fully integrated global commercial organization, with a strong focus on patient-centric therapies [6][10] - The company is actively engaging with regulatory authorities and preparing for the launch of paltusotine, which is seen as a defining milestone [10][24] - The company is also pursuing a Phase III trial for adomelna in congenital adrenal hyperplasia (CAH), aiming to redefine treatment standards [11][29] 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 of paltusotine to become the new standard of care in acromegaly, addressing significant unmet needs [23][24] Other Important Information - The company ended Q1 2025 with approximately $1.3 billion in cash, which is expected to fund operations into 2029 [42] - The company has received orphan drug designation for paltusotine in the EU, highlighting the unmet need in acromegaly [25] Q&A Session Summary Question: Could you talk about the powering of your very innovative primary endpoint? - The study is highly powered to detect statistically significant differences between treatment and placebo arms, and the endpoint is better described as a composite rather than a co-primary endpoint [47][49] Question: Is the CALM CAH study design fully signed off on by FDA? - The protocol was developed based on input from the FDA and other health authorities, and they are aware of the final study design [53][54] Question: What is the rationale for looking at morning dosing versus evening dosing in the fourth cohort? - Morning dosing may be more convenient for patients, and the study aims to explore this option [60][61] Question: How are you thinking about launch strategy in different geographies? - The company is preparing for the launch in Germany, where there is a significant unmet need, and is also considering expansion into Brazil [68][69] Question: Can you give an update on enrollment and follow-up for the long-term extension study? - Enrollment is proceeding, and updates will be provided once a critical mass is reached [87] Question: Is there a risk that A4 variability may lead to some non-responders? - Responder analyses are generally conducted at single points in time, and there is confidence that the compound can achieve both components of the composite primary endpoint [57][58]

Clinical Trials and Drug Development - The company reported positive topline data from the PATHFNDR-1 study for paltusotine, achieving the primary endpoint and all secondary endpoints, with no serious adverse events reported[97]. - The PATHFNDR-2 study also met statistical significance (p<0.0001) on the primary endpoint, with paltusotine being well-tolerated and no serious adverse events reported[98]. - The company plans to initiate the CAREFNDR Phase 3 clinical trial for carcinoid syndrome in the second half of 2025, focusing on the frequency of flushing episodes as the primary endpoint[102]. - Atumelnant is being developed for conditions caused by excess ACTH, with an estimated 17,000 potential candidates for treatment in the U.S.[104]. - The Phase 1 study of atumelnant showed positive topline data, demonstrating dose-dependent reductions in cortisol levels and no serious adverse events[105]. - The CALM-CAH Phase 3 trial for congenital adrenal hyperplasia (CAH) is set to begin in the second half of 2025, with the primary endpoint being the proportion of participants with androstenedione levels ≤ULN at week 32[107]. - The company is collaborating with the NIH for a clinical trial of atumelnant in ACTH-dependent Cushing's Syndrome, with plans to initiate a Phase 2/3 study in the second half of 2025[108]. - The company has developed a first-in-class nonpeptide drug conjugate, CRN09682, for treating SST2+ neuroendocrine tumors, with a Phase 1/2 study approved to begin[109]. - The company is developing PTH receptor antagonists for primary hyperparathyroidism, with an estimated incidence of 200,000 cases in the U.S.[110]. - The company is also developing TSHR antagonists for Graves' disease, affecting around 3 million people in the U.S.[111]. - The company has identified investigational SST3 agonists for treating Autosomal Dominant Polycystic Kidney Disease, which affects over 300,000 individuals[112]. Financial Performance - As of March 31, 2025, the company had unrestricted cash and equivalents of $1.3 billion, supporting ongoing operations[121]. - The company has incurred cumulative net losses of $1.0 billion since inception, with expected increases in expenses as clinical trials progress[122]. - The company has not generated any product sales and relies on grant and license revenues for funding[120]. - Research and development expenses increased to $76.2 million for the three months ended March 31, 2025, compared to $53.3 million for the same period in 2024, reflecting a change of $22.9 million[137]. - The company reported a net loss of $96.8 million for the three months ended March 31, 2025, compared to a net loss of $66.9 million for the same period in 2024, representing an increase in loss of $29.9 million[136]. - Total operating expenses rose to $111.8 million for the three months ended March 31, 2025, up from $74.2 million in 2024, marking an increase of $37.6 million[136]. - Other income, net increased to $14.6 million for the three months ended March 31, 2025, compared to $7.1 million in 2024, an increase of $7.5 million[147]. - Cash used in operating activities was $88.5 million for the three months ended March 31, 2025, compared to $52.9 million in 2024, an increase of $35.6 million[148]. - The company had unrestricted cash, cash equivalents, and investment securities of $1.3 billion as of March 31, 2025, with an accumulated deficit of $1.0 billion[148]. - Research and development expenses for the paltusotine program were $16.5 million for the three months ended March 31, 2025, compared to $13.0 million in 2024, an increase of $3.5 million[139]. - Selling, general and administrative expenses increased to $35.5 million for the three months ended March 31, 2025, from $20.8 million in 2024, reflecting an increase of $14.7 million[145]. - The total external research and development expenses amounted to $32.2 million for the three months ended March 31, 2025, compared to $23.7 million in 2024, an increase of $8.5 million[139]. - Net cash provided by financing activities was $4.4 million for the three months ended March 31, 2025, compared to $393.6 million for the same period in 2024[150]. Future Financial Outlook - The company plans to increase research and development expenses in the foreseeable future to support ongoing clinical programs and discovery efforts[131]. - Future capital requirements will depend on various factors, including the costs and timing of clinical trials and regulatory reviews[152]. - The company expects to finance cash needs through equity offerings, debt financings, or collaborations, which may dilute stockholder ownership[153]. - In the 2019 ATM Offering, the company issued 1,223,775 shares for net proceeds of approximately $43.4 million[154]. - The 2024 ATM Offering allows the company to sell up to $350.0 million of common stock, with no shares sold as of March 31, 2025[155]. - A stock purchase agreement in February 2024 resulted in the issuance of 8,333,334 shares at $42.00 per share, generating approximately $350.0 million in gross proceeds[156]. - An underwritten public offering on October 10, 2024, raised approximately $542.8 million from the sale of 11,500,000 shares at $50.00 per share[157]. Market and Economic Factors - The company has exposure to fluctuations in foreign currency rates due to contracts with vendors and CROs in various countries, but believes this exposure to be immaterial[162]. - Inflationary factors may adversely affect operating results, although no material impact has been observed to date[163].

Financial Performance - Revenues for Q1 2025 were $0.4 million, a decrease from $0.6 million in Q1 2024[7] - Net loss for Q1 2025 was $96.8 million, compared to a net loss of $66.9 million in Q1 2024[12] - Cash, cash equivalents, and investments totaled $1.3 billion as of March 31, 2025, down from $1.4 billion at the end of 2024, expected to fund operations into 2029[12] Expenses - Research and development expenses increased to $76.2 million in Q1 2025 from $53.3 million in Q1 2024, driven by higher personnel and manufacturing costs[7] - Selling, general and administrative expenses rose to $35.5 million in Q1 2025, compared to $20.8 million in Q1 2024, primarily due to increased personnel and outside services costs[7] Regulatory and Clinical Updates - The FDA PDUFA target action date for paltusotine NDA is set for September 25, 2025[7] - The Phase 3 CALM-CAH study for atumelnant is designed to normalize androstenedione levels with physiological glucocorticoid replacement[7] - Crinetics plans to initiate the CAREFNDR Phase 3 trial of paltusotine in carcinoid syndrome in the second half of 2025[7] - The marketing authorization application for paltusotine has been validated by the EMA, with a potential decision expected in the first half of 2026[4] Future Events - The company has scheduled an R&D Day for June 26, 2025, to provide updates on its early-stage pipeline[7]

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]

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 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 first quarter 2025 financial results on May 8, 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 1-833-470-1428 or international dial-in number 1-404-975-4839, with Conference ID: CRNXQ1 [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]