Core Points - Crinetics Pharmaceuticals granted stock options and restricted stock units (RSUs) to 26 new non-executive employees as part of its 2021 Employment Inducement Incentive Award Plan [1][2] - The stock options total 124,950 shares with an exercise price of $26.85 per share, equal to the closing price on April 10, 2025 [2] - The RSUs granted amount to 84,725 shares, with both stock options and RSUs vesting over four years [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 an investigational oral selective somatostatin receptor type 2 (SST2) nonpeptide agonist for acromegaly and carcinoid syndrome [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]

SAN DIEGO, April 10, 2025 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that on April 10, 2025, the Compensation Committee of the Board of Directors granted non-qualified stock option awards to purchase an aggregate of 124,950 shares of its common stock and granted an aggregate of 84,725 restricted stock unit (“RSU”) awards to 26 new non-executive employees, in each case, under the Crinetics Pharmaceuticals, Inc. 2021 Employment Inducement Incentive Award Plan (the “2021 ...

I covered Crinetics Pharma (NASDAQ: CRNX ) back in 2023, when it was developing Paltusotine for acromegaly in a phase 3 trial. Now, they have positive data and a September 25 PDUFA date, so let us take a look.About the TPT ServiceThanks for reading. At the Total Pharma Tracker, we offer the following:-Our Android app and website features a set of tools for DIY investors, including a work-in-progress software where you can enter any ticker and get extensive curated research material. For investors requiring ...

SAN DIEGO, March 27, 2025 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for paltusotine, the first once-daily, oral, selectively-targeted somatostatin receptor type 2 nonpeptide agonist, for the proposed treatment and long-term maintenance therapy of acromegaly, a serious, rare and progressive endocrine disorder characterized by consistently elevated levels of growth horm ...

Core Viewpoint - Crinetics Pharmaceuticals has granted stock options and restricted stock units (RSUs) to new 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 95,675 stock options to fifteen new non-executive employees and 80,000 to one new executive employee [1]. - Additionally, 40,775 RSUs were awarded to sixteen new non-executive employees and 52,000 to one new executive employee [1]. - The stock options have an exercise price of $33.75 per share, equal to the closing price of Crinetics' common stock on March 10, 2025 [2]. Group 2: Vesting Schedule - The stock options will vest over four years, with 25% vesting on the one-year anniversary and the remaining shares vesting in 36 equal monthly installments [2]. - The RSUs will also vest over four years in equal annual installments starting on the one-year anniversary [2]. Group 3: 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 [3].

Core Viewpoint - Crinetics Pharmaceuticals has granted stock options and restricted stock units (RSUs) to new 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 non-qualified stock options to purchase a total of 95,675 shares to fifteen new non-executive employees and 80,000 shares to one new executive employee [1]. - An aggregate of 40,775 RSUs was awarded to sixteen new non-executive employees and 52,000 RSUs to one new executive employee [1]. - The stock options have an exercise price of $33.75 per share, equal to the closing price of Crinetics' common stock on March 10, 2025 [2]. Group 2: Vesting Schedule - The stock options will vest over four years, with 25% vesting on the one-year anniversary and the remaining shares vesting in 36 equal monthly installments [2]. - The RSUs will also vest over four years in equal annual installments starting on the one-year anniversary [2]. Group 3: 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 [3].

Financial Data and Key Metrics Changes - Revenues for the full year ended December 31, 2024, were $1 million, down from $4 million in 2023, with no revenues reported for Q4 2024 or Q4 2023 [55] - 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, primarily due to higher personnel costs and increased development activities [56] - General and administrative expenses rose to $28.2 million for Q4 2024 and $99.7 million for the full year, up from $17.1 million and $58.1 million in 2023, driven by increased personnel costs and commercial planning activities [57] - The net loss for Q4 2024 was $80.6 million, compared to a net loss of $60.1 million in Q4 2023, with a full-year net loss of $298.4 million versus $214.5 million in 2023 [58] - The company anticipates a cash burn of between $340 million and $380 million for 2025, reflecting plans to initiate four late-stage trials [59] - As of the end of 2024, the company had approximately $1.4 billion in cash and investments, expected to fund operations into 2029 [60] Business Line Data and Key Metrics Changes - The company is preparing for the anticipated launch of paltusotine, with a focus on building commercial and medical affairs teams [10][11] - Significant progress was made in clinical readouts for paltusotine's second indication, carcinoid, with Phase III trial site activations expected to begin soon [14][33] - Atumelnant showed positive results in Phase II studies for congenital adrenal hyperplasia (CAH) and Cushing's disease, with plans for late-stage studies in both adults and children [15][18] Market Data and Key Metrics Changes - The company is expanding its presence in Europe, with plans to file for EMA approval for acromegaly shortly and establishing a hub in Zug, Switzerland [13] - The company is focusing on activating healthcare professionals and patients to demand better therapies for acromegaly, highlighting the significant unmet need in the market [22][23] Company Strategy and Development Direction - The company aims to evolve into a fully integrated global pharmaceutical company, leveraging its infrastructure for future launches [13][66] - The commercial strategy includes activating healthcare professionals and patients, ensuring access to paltusotine, and promoting adherence to treatment regimens [26][28] - The company plans to submit four INDs in total for various drug candidates in 2025, including a PTH antagonist and a TSH antagonist [50][51] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting the strong clinical data for paltusotine and the anticipated approval in September 2025 [10][71] - The company is confident in its ability to provide optimal access for all acromegaly patients and is actively engaging with payers [26][27] - Management emphasized the importance of building a strong commercial organization to support the launch of paltusotine and future products [20][29] Other Important Information - The company has made significant progress in its pipeline, with four late-stage clinical programs expected to be underway in 2025 [41] - The company is transitioning to a commercial stage with the hiring of a new Chief Commercial Officer, Isabel Kalofonos, who has extensive experience in launching rare disease products [11][12] Q&A Session Summary Question: Can you elaborate on the ongoing launch preparations for paltusotine? - Management highlighted strong data for acromegaly and emphasized the importance of the orphan drug designation from the EMA, which recognizes the clinical advantage of paltusotine [71][72] Question: How do you envision your disclosures as you continue your dialogue with the FDA? - Management confirmed that they have not yet had the mid-cycle review but are scheduled to do so, maintaining a productive relationship with the FDA [82][83] Question: What strategies are you working on to motivate acromegaly patients to see their healthcare providers? - Management discussed engaging patients through disease awareness campaigns and educational events to highlight the unmet needs in the marketplace [90][92] Question: Is there any update on the open-label extension for the CAH Phase II trial? - Management confirmed that sites are activating and patients are eager to see how they perform in the open-label extension [95] Question: Can you share any additional details on Cohort 4 in the TouCAHn study? - Management indicated that they have not started discussing Cohort 4 yet but will provide details on the overall study design for the Phase III program soon [101][102] Question: How are you prioritizing the three non-oncology assets moving forward into IND filing this year? - Management stated that they are fortunate to be able to move all programs forward at their natural pace without needing to prioritize [120] Question: What is the current thinking behind the lack of observed dose response in the 17OHP decrease across all doses? - Management explained that 17OHP is a variable biomarker, and the clinical outcome benefits observed are significant, indicating the potential of atumelnant as a treatment for CAH [124][126]

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]