SAN DIEGO, May 30, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX), today announced the appointment of Robert M. Cuddihy, M.D., as senior vice president of Medical Affairs. Dr. Cuddihy is a board-certified physician in endocrinology, diabetes and metabolism with more than 30 years of experience spanning clinical practice and pharmaceutical industry medical affairs. "Dr. Cuddihy's wealth of knowledge and experience both as a practicing physician in endocrinology and working within the ...

Core Insights - Crinetics Pharmaceuticals has appointed Dr. Robert M. Cuddihy as senior vice president of Medical Affairs, bringing over 30 years of experience in endocrinology and pharmaceutical medical affairs [1][2] - Dr. Cuddihy will play a crucial role in the development and potential commercialization of investigational product candidates, including paltusotine and atumelnant, which target high unmet needs in endocrine diseases [2] - The company is focused on developing novel therapeutics for endocrine diseases and related tumors, with paltusotine in Phase 3 for acromegaly and Phase 2 for carcinoid syndrome, while atumelnant is completing Phase 2 studies for congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome [3] Company Overview - Crinetics Pharmaceuticals is a clinical-stage pharmaceutical company dedicated to discovering, developing, and commercializing innovative therapies for endocrine diseases [3] - The company's drug candidates are all 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, thyroid eye disease, diabetes, and obesity [3]

SAN DIEGO, May 22, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX) a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, today announced that the late-breaking abstracts accepted for presentation at the Endocrine Society's annual meeting (ENDO 2024) were released earlier than the previously announced embargoed date. The abstract for the Phase 2, open-label study of ...

Financial Data and Key Metrics Changes - The company ended Q1 2024 with approximately $900 million in cash and investments, bolstered by a $350 million private placement in February [18][36] - Research and development expenses increased to $53.3 million in Q1 2024 from $38.5 million in Q1 2023, primarily due to higher personnel costs and development activities [37] - Revenues decreased to $0.6 million in Q1 2024 from $2.7 million in Q1 2023, with current revenues mainly from a licensing arrangement for Paltusotine [38] - General and administrative expenses rose to $20.8 million in Q1 2024 from $12.2 million in Q1 2023, attributed to higher personnel costs [61] - The net loss for Q1 2024 was $66.9 million, compared to a net loss of $46 million in Q1 2023 [61] - Net cash used for operating activities was $52.9 million in Q1 2024, with an expected cash burn of $50 million to $60 million per quarter for the remainder of 2024 [62] Business Line Data and Key Metrics Changes - The company reported positive results from late-stage clinical studies for Paltusotine in patients with acromegaly and carcinoid syndrome, supporting its potential NDA filing [9][16] - Paltusotine demonstrated significant improvements in acromegaly symptom control and rapid IGF-1 response, which could allow faster dose optimization compared to current treatments [53] - Atumelnant, the second investigational compound, is in development for CAH and Cushing's disease, with initial data expected to be presented at the upcoming Endocrine Society meeting [55][59] Market Data and Key Metrics Changes - The company is actively engaging with leading payers to understand market dynamics for Paltusotine, which has received positive feedback from early discussions [26] - There is a significant population of patients with carcinoid syndrome who are currently untreated, presenting a unique market opportunity for Paltusotine [131] Company Strategy and Development Direction - The company aims to advance Paltusotine towards regulatory submissions and continue developing its pipeline, including Atumelnant and other early-stage programs [39][60] - A campaign will be launched to increase awareness among healthcare providers about the unmet needs in current treatments for acromegaly and carcinoid syndrome [25] - The company plans to align with the FDA on Phase 3 study designs for both carcinoid syndrome and CAH, with a focus on addressing the limitations of current therapies [49][80] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong progress made in Q1 2024 and anticipates multiple upcoming milestones from clinical candidates [39][50] - The company is committed to investing in its discovery capabilities to ensure long-term success and address higher prevalence indications [50] Other Important Information - The company will present five abstracts at the ENDO Conference, including late-breaking data from clinical studies of Atumelnant [11] - The PATHFNDR Phase 3 program for acromegaly has met all primary and secondary endpoints, supporting the transition to regulatory filing [28] Q&A Session Summary Question: Insights on Cushing's data set - Management highlighted the importance of cortisol reduction in patients with Cushing's disease and expressed interest in the results from the ongoing study [41][42] Question: Satisfaction with Atumelnant's pharmacodynamics - Management indicated that satisfaction levels would be clearer after presenting data at the Endocrine Society meeting [45][47] Question: Phase 3 design for carcinoid syndrome - Management discussed the importance of measuring symptom frequency and severity in the Phase 3 trial, with sample sizes expected to be between 80 and 150 patients [80] Question: Feedback from physicians on Paltusotine - Positive feedback was received from physicians regarding the potential of Paltusotine to address the limitations of current injection therapies for carcinoid syndrome [108] Question: Commercialization overlap for CAH and acromegaly - There is a high degree of overlap in treatment centers and prescribers for CAH and acromegaly, which could facilitate commercialization efforts [137][138]

SAN DIEGO, May 10, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX) today announced that on May 10, 2024, the Compensation Committee of Crinetics' Board of Directors granted non-qualified stock option awards to purchase an aggregate of 176,000 shares of its common stock to fifteen 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 ...

Crinetics Pharmaceuticals, Inc. (CRNX) came out with a quarterly loss of $0.93 per share versus the Zacks Consensus Estimate of a loss of $0.84. This compares to loss of $0.85 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -10.71%. A quarter ago, it was expected that this company would post a loss of $0.89 per share when it actually produced a loss of $0.90, delivering a surprise of -1.12%.Over the last four quarters, the com ...

Financial Performance - Revenues for the three months ended March 31, 2024, were $640,000, a decrease from $2.679 million in the same period of 2023[7] - Total operating expenses increased to $74.169 million in Q1 2024 from $50.657 million in Q1 2023, representing a 46.5% increase[7] - Net loss for the three months ended March 31, 2024, was $66.930 million, compared to a net loss of $45.995 million in the same period of 2023, reflecting a 45.4% increase in losses[7] - The company reported an accumulated deficit of $720.6 million as of March 31, 2024[12] - The company anticipates continued net losses and plans to raise additional capital through equity offerings, debt financings, or collaborations[12] - The company reported a net loss of $66,930 for the three months ended March 31, 2024, compared to a net loss of $45,995 for the same period in 2023[30] - The company incurred cumulative net losses of $720.6 million as of March 31, 2024, with expectations of increased expenses and operating losses due to ongoing clinical trials and research activities[62] - The company anticipates continued net losses for the foreseeable future, with no products approved for sale yet[76] Cash and Liquidity - As of March 31, 2024, the company had $901.0 million in unrestricted cash, cash equivalents, and investment securities, sufficient to meet funding requirements for at least the next 12 months[12] - The company had cash, cash equivalents, and restricted cash of $397,224 at the end of the period, compared to $42,494 at the end of the same period in 2023[30] - Net cash used in operating activities was $52,856 for the three months ended March 31, 2024, compared to $40,718 in the same period of 2023[30] - The company provided $393,574 in net cash from financing activities during the three months ended March 31, 2024, significantly higher than $484 in the prior year[30] - The company reported unrestricted cash, cash equivalents, and investment securities of $901.0 million as of March 31, 2024, with an accumulated deficit of $720.6 million[76] - Net cash provided by financing activities was $393.6 million in Q1 2024, significantly up from $0.5 million in Q1 2023, due to proceeds from the sale of common stock[99] - Cash and cash equivalents rose significantly to $395,924 thousand from $54,897 thousand, indicating a substantial liquidity improvement[168] Research and Development - The company plans to submit a New Drug Application for paltusotine for the treatment of acromegaly to the FDA in the second half of 2024, with potential approval in 2025[17] - Positive topline results from a Phase 2 study of paltusotine showed rapid and sustained reductions in bowel movement frequency and flushing episodes in patients with carcinoid syndrome[18] - The company is conducting a Phase 2 study of CRN04894 in CAH patients, with initial data expected in the second quarter of 2024[23] - The company has initiated a clinical trial of CRN04894 in patients with Cushing's disease, with initial data expected in the second quarter of 2024[24] - Research and development expenses increased to $53,341,000 for the quarter ended March 31, 2024, up from $38,468,000 in the same quarter of 2023, representing a rise of $14,873,000[73] - Research and development expenses rose to $53.3 million in Q1 2024 from $38.5 million in Q1 2023, driven by a $9.4 million increase in personnel costs and higher outside services[95] - The company expects to select a development candidate for its SST3 agonist program in the first half of 2024, targeting Autosomal Dominant Polycystic Kidney Disease (ADPKD) which affects 1 in 1,000 individuals[57] - Research and development expenses for the paltusotine program were $13.0 million for the quarter ended March 31, 2024, compared to $12.4 million in the same quarter of 2023, primarily due to increased manufacturing activities[74] Collaborations and Investments - The company entered into a collaboration and license agreement with Radionetics for the development of radiotherapeutics in October 2021[40] - The Company acquired a 64% majority stake in Radionetics through the exchange of 50,500,000 shares of common stock and a warrant to purchase additional shares[42] - In August 2023, the Company invested $5.0 million to purchase 14,404,656 shares of preferred stock in Radionetics, alongside other investors[42] - The Company's ownership stake in Radionetics decreased from 55% to 31% following the August 2023 transaction, resulting in net dilution[42] - As of March 31, 2024, the Company's investment in Radionetics was written down to zero, with equity method losses recorded at $0.5 million for the quarter[43] - The Company recognized $0.6 million in revenue from the estimated transaction price of $14.0 million during the three months ended March 31, 2024[49] - The Company completed a private placement offering of 8,333,334 shares of common stock at $42.00 per share, generating net proceeds of approximately $335.5 million[51] - The Company issued 1,223,775 shares of common stock in an ATM Offering for net proceeds of approximately $43.4 million during the three months ended March 31, 2024[52] Stock and Equity - The total stock options outstanding increased to 14,456,739 as of March 31, 2024, with an average exercise price of $23.17[36] - The weighted-average fair value of stock options awarded was $27.38 per share for the three months ended March 31, 2024, compared to $12.29 per share in the prior year[38] - Unrecognized stock-based compensation cost related to option awards was $150.4 million as of March 31, 2024, expected to be recognized over a remaining weighted-average period of 2.2 years[39] - The company granted 873,886 restricted stock units during the three months ended March 31, 2024, with an average grant date fair value of $43.51[37] - The company had 78,859,510 shares of common stock outstanding as of May 6, 2024[165] Market and Economic Conditions - The company has been impacted by changes in U.S. and international trade policies, particularly tariffs and export controls affecting products manufactured in China[121] - Cybersecurity risks are increasing due to reliance on information technology systems, with potential vulnerabilities from various cyber threats[122] - The company is exposed to foreign currency exchange rate risk, with net realized and unrealized losses from foreign currency transactions totaling ($186,000) for the three months ended March 31, 2024[117] Future Plans and Development - The company is focused on developing oral nonpeptide therapeutics targeting peptide GPCRs for endocrine diseases, with a pipeline including paltusotine for acromegaly and carcinoid syndrome[133] - The company is developing TSHR antagonists for Graves' disease and Thyroid Eye Disease, with plans to select a development candidate in 2024[83] - The company expects to select a development candidate for its parathyroid hormone antagonist program in the first half of 2024[45] - The company is advancing additional product candidates through preclinical studies alongside paltusotine[133] - The open label extension phases of the PATHFNDR trials for paltusotine are ongoing[139]

Crinetics Pharmaceuticals’ (CRNX) shares gained 19.1% on Mar 19 after the company reported positive top-line data from the second (PATHFNDR-2) of two late-stage studies evaluating the efficacy and safety of lead candidate, paltusotine, for the treatment of acromegaly.Acromegaly is a rare endocrine disease generally caused by a pituitary adenoma, which is a non-cancerous tumor in the pituitary that secretes growth hormone.The PATHFNDR-2 study is evaluating paltusotine, an oral SST2 agonist, in participants w ...

Crinetics Pharmaceuticals, Inc. (CRNX) shares ended the last trading session 19.1% higher at $45.18. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 0.3% gain over the past four weeks.The sudden surge in the stock price was observed after Crinetics reported achieving primary and all key secondary endpoints, with statistical significance, in the second (PATHFNDR-2) of two late-stage studies evaluating the efficacy a ...

56% of Participants on Paltusotine Achieved IGF-1 ≤1.0 xULN vs. 5% on Placebo (p<0.0001) Paltusotine was Generally Well-tolerated with No Serious Adverse Events Positive Topline Results Support Planned NDA Submission to the FDA in 2H 2024 Management Will Host a Conference Call Today at 8:30 a.m. Eastern Time SAN DIEGO, March 19, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX) a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel t ...