Paltusotine Treatment Demonstrated Rapid and Sustained Reductions in Frequency and Severity of Flushing Episodes and Bowel Movements Paltusotine was Generally Well-Tolerated and Showed an Overall PK Profile Consistent with Prior Studies Results Confirm Initial Positive Data Previously Reported Management to Host a Conference Call Today at 4:30 p.m. Eastern Time SAN DIEGO, March 12, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX) a clinical stage pharmaceutical company focused on the ...

SAN DIEGO, March 11, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX) today announced that on March 10, 2024, the Compensation Committee of Crinetics' Board of Directors granted non-qualified stock option awards to purchase an aggregate of 42,450 shares of its common stock to five new non-executive employees under the Crinetics Pharmaceuticals, Inc. 2021 Employment Inducement Incentive Award Plan (the "2021 Inducement Plan"). The stock options were granted as inducements material to th ...

koya79 Financial and Clinical Progress Positions Crinetics for Market Leadership Much has changed at Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX) since my first look nearly a year ago. Back then, I expressed concern over their oral solution for acromegaly and made the argument that paltusotine, by the nature of its oral administration, would likely not be able to replicate the efficacy and safety of existing subcutaneous drugs like octreotide. Nonetheless, I did recognize the potential of Crinetics' dr ...

Financial Data and Key Metrics Changes - The company reported a net loss of $60.1 million for Q4 2023, compared to a net loss of $45 million for the same period in 2022, and a full-year net loss of $214.5 million in 2023 versus $163.9 million in 2022 [68] - Research and development expenses increased to $45.6 million for Q4 2023 and $168.5 million for the full year, up from $37 million and $130.2 million in 2022, primarily due to higher personnel costs and increased outside services [14] - General and administrative expenses rose to $17.1 million for Q4 2023 and $58.1 million for the full year, compared to $11.3 million and $42.4 million in 2022, attributed to higher personnel costs [40] - Revenues were $4 million for the full year 2023, down from $4.7 million in 2022, with no revenues reported for Q4 2023 compared to $0.7 million in Q4 2022 [41] Business Line Data and Key Metrics Changes - The PATHFNDR-1 trial for Paltusotine in acromegaly achieved its primary endpoint with 83% of patients meeting the target, compared to only 4% in the placebo group, demonstrating a highly statistically significant difference [4][3] - In the ongoing PATHFNDR-2 trial, 111 participants were enrolled, and top-line results are expected to be shared soon, with the goal of seeking a broad indication for Paltusotine in treating acromegaly [13][23] - For carcinoid syndrome, initial results from a Phase 2 trial showed a 65% reduction in excess bowel movement frequency and flushing episodes, indicating promising efficacy [64][35] Market Data and Key Metrics Changes - The combined market opportunity for acromegaly and carcinoid syndrome is projected to be multi-billion dollars, prompting the company to build out its commercial organization and identify key prescribers [30] - The company anticipates a potential launch of Paltusotine in 2025, focusing on developing commercial capabilities for these markets [30] Company Strategy and Development Direction - The company aims to complete multiple transformative milestones in 2024 and 2025, including the completion of PATHFNDR-2 and the initiation of Phase 3 studies in carcinoid syndrome and congenital adrenal hyperplasia (CAH) [2] - The strategy includes expanding the pipeline with multiple preclinical programs targeting various endocrine-related diseases, including a parathyroid hormone receptor antagonist and a TSH antagonist [24] - The company is focused on building a strong commercial organization to support the launch of Paltusotine and enhance market access [30] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming year, highlighting the transformative potential of 2024 for the company as it progresses with regulatory submissions and commercialization efforts [70] - The management team emphasized the importance of patient-centric data and symptom control in their discussions with payors and physicians, which will be crucial for the commercial strategy [83][104] Other Important Information - The company announced a private placement equity financing of approximately $350 million, strengthening its financial position with a pro forma cash balance of approximately $900 million [54][67] - The company expects its cash burn to be approximately $50 million to $60 million per quarter in 2024, with sufficient funds to support operations into 2028 [69] Q&A Session Summary Question: What is the status of PATHFNDR-2 and patient eligibility? - Management clarified that patients not currently receiving medical therapy are enrolled, and those previously unresponsive to SRLs are excluded from the trial [43][7] Question: What are the expectations for the carcinoid syndrome data? - Management expressed that a win for the final data set would be confirming the interim results and providing more information on exploratory endpoints [78] Question: How important is the acromegaly symptoms diary for labeling? - Management highlighted that while biochemical control is a regulatory endpoint, symptom control is crucial for patient satisfaction and will be a significant part of the commercial strategy [82][83] Question: What is the commercial strategy for Paltusotine? - The strategy involves discussions with payors regarding pricing and the value proposition of Paltusotine compared to injectable therapies, emphasizing potential cost savings [85][104] Question: What are the baseline characteristics for PATHFNDR-2? - Management indicated that they have not yet completed the analysis of baseline characteristics but expect the patient demographics to be representative of the general population [108]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Form 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐ 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) (State or other jurisdiction of incorpora ...

SAN DIEGO, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX) ("Crinetics" or the "Company"), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, announced today that it has agreed to sell 8,333,334 shares of its common stock at a price of $42.00 per share to a select group of institutional and accredited healthcare specialist investors in an oversubscr ...

Phase 3 PATHFNDR-2 Study Topline Results Expected in March 2024; Pending Results, NDA Submission in Acromegaly Anticipated 2H 2024 Announced a $350 Million Private Placement Equity Financing "As we reflect on our achievements in 2023, this was a truly significant year for Crinetics, laying the foundation for our next phase of growth," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "Our lead investigational compound, paltusotine, continues to demonstrate highly promising resul ...

SAN DIEGO, Feb. 12, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX) today announced that on February 10, 2024, the Compensation Committee of Crinetics' Board of Directors granted non-qualified stock option awards to purchase an aggregate of 73,000 shares of its common stock to nine new non-executive employees under the Crinetics Pharmaceuticals, Inc. 2021 Employment Inducement Incentive Award Plan (the "2021 Inducement Plan"). The stock options were granted as inducements material to ...

10. EQUITY INCENTIVE PLANS The Company adopted the 2021 Employment Inducement Incentive Award Plan (the "2021 Inducement Plan") in December 2021. The Company initially reserved 1,500,000 shares of the Company's common stock for issuance pursuant to awards granted under the 2021 Inducement Plan. The terms of the 2021 Inducement Plan are substantially similar to the terms of the Company's 2018 Incentive Award Plan with the exception that awards may only be made to an employee who has not previously been an em ...

FORM 10-Q ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Mark One) For the quarterly period ended June 30, 2023 Crinetics Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 26-3744114 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identi ...