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Crinetics Pharmaceuticals Announces November 2025 Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Globenewswire· 2025-11-10 21:28
Core Insights - Crinetics Pharmaceuticals granted stock options and restricted stock units (RSUs) to new non-executive employees as part of its 2021 Employment Inducement Incentive Award Plan, totaling 37,675 shares in stock options and 25,300 RSUs [1][2] Group 1: Stock Options and RSUs - The stock options have an exercise price of $41.45 per share, equal to the closing price on November 10, 2025 [2] - Stock options will vest over four years, with 25% vesting on the one-year anniversary and the remainder in 36 equal monthly installments, contingent on continued employment [2] - RSUs will also vest over four years in equal annual installments starting on the one-year anniversary, subject to continued employment [2] Group 2: Company Overview - Crinetics Pharmaceuticals is focused on transforming the treatment of endocrine diseases and related tumors, emphasizing patient needs [3] - The company specializes in discovering and developing therapies targeting G-protein coupled receptors (GPCRs) with tailored pharmacology [3] - Crinetics' lead product, PALSONIFY™ (paltusotine), is the first oral treatment approved by the U.S. FDA for adults with acromegaly who have inadequate surgical responses [4] Group 3: Pipeline and Development - The company has a deep pipeline with over 10 disclosed programs, including atumelnant, which is in late-stage development for congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome [4] - Additional discovery programs target various endocrine conditions, including neuroendocrine tumors, Graves' disease, polycystic kidney disease, hyperparathyroidism, diabetes, obesity, and GPCR-targeted oncology indications [4]
Berkshire warns of AI deepfakes impersonating Warren Buffett
Reuters· 2025-11-07 17:38
Core Message - Warren Buffett emphasizes the uniqueness of his persona, stating that there is only one "Oracle of Omaha" and addressing concerns regarding AI-generated impersonations of him [1] Summary by Categories - **AI Impersonation Concerns** - The rise of AI technology has led to the creation of impersonations of notable figures, including Warren Buffett [1] - Buffett's statement serves as a warning to those who generate or view such AI-created content [1]
Crinetics Pharmaceuticals, Inc. (CRNX) Reports Q3 Loss, Lags Revenue Estimates
ZACKS· 2025-11-06 23:21
Core Insights - Crinetics Pharmaceuticals, Inc. (CRNX) reported a quarterly loss of $1.38 per share, which was worse than the Zacks Consensus Estimate of a loss of $1.27, and compared to a loss of $0.96 per share a year ago, indicating a significant decline in performance [1] - The company posted revenues of $0.14 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 94.7%, while revenues were zero a year ago [2] - The stock has underperformed, losing about 16.8% since the beginning of the year, contrasting with the S&P 500's gain of 15.6% [3] Financial Performance - The earnings surprise for the recent quarter was -8.66%, and the company has only surpassed consensus EPS estimates once in the last four quarters [2][3] - The current consensus EPS estimate for the upcoming quarter is -$1.30 on revenues of $3.25 million, and for the current fiscal year, it is -$4.85 on revenues of $4.98 million [7] Market Outlook - The company's stock is currently rated Zacks Rank 3 (Hold), indicating expected performance in line with the market in the near future [6] - The outlook for the Medical - Drugs industry, where Crinetics operates, is relatively strong, ranking in the top 39% of over 250 Zacks industries, suggesting potential for better performance compared to lower-ranked industries [8]
Crinetics Pharmaceuticals, Inc. 2025 Q3 - Results - Earnings Call Presentation (NASDAQ:CRNX) 2025-11-06
Seeking Alpha· 2025-11-06 22:31
Core Insights - The article emphasizes the importance of enabling Javascript and cookies in browsers to prevent access issues [1] Group 1 - The article suggests that users may face blocks if ad-blockers are enabled, indicating a need to disable them for proper access [1]
Crinetics Pharmaceuticals(CRNX) - 2025 Q3 - Earnings Call Transcript
2025-11-06 22:30
Financial Data and Key Metrics Changes - In Q3 2025, the company recognized $0.1 million in revenue from a licensing agreement, with no revenue from Palsanafy due to the timing of its approval [25][26] - Research and development expenses increased to $90.5 million from $80.3 million in the previous quarter, reflecting ongoing investments in clinical programs [26] - Selling, general, and administrative expenses rose to $52.3 million from $49.8 million, driven by launch-related investments [26] - The company ended the quarter with $1.1 billion in cash and equivalents, maintaining guidance for net cash used in operations between $340 million and $370 million for 2025 [27][26] Business Line Data and Key Metrics Changes - The launch of Palsanafy is progressing well, with significant early adoption among patients switching from other therapies and some newly diagnosed patients starting treatment [8][10] - The company aims to make Palsanafy the first-line treatment for acromegaly, with a focus on transitioning patients from injectable therapies [11][20] Market Data and Key Metrics Changes - The company is actively engaging with both community and academic healthcare providers, with 70% of prescriptions coming from community settings [22][37] - Payers have shown favorable responses, with prior authorizations being processed quickly and some approvals extending up to 12 months [23][50] Company Strategy and Development Direction - The company is focused on establishing Palsanafy as foundational care for acromegaly and plans to expand efforts to reach previously diagnosed patients who have discontinued therapy [12][28] - The strategy includes a three-phase approach to improve patient care, starting with switching current patients, then re-engaging those lost to follow-up, and finally enhancing diagnosis awareness [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the positive feedback from patients, physicians, and payers regarding Palsanafy, indicating a strong launch trajectory [28][52] - The company anticipates significant data readouts from ongoing clinical trials in the coming months, which are expected to drive further value [28][29] Other Important Information - The company has delayed IND timelines for certain candidates due to identified weaknesses, prioritizing the best backup molecules [13] - The clinical pipeline is expected to expand in 2026, with new candidates entering clinical trials [13][29] Q&A Session Summary Question: Inquiry about PFS data in NANETS patients with Paltuzatine - Management discussed the known effects of somatostatin receptor ligands on neuroendocrine tumors and the expectation of similar outcomes for Paltuzatine [31] Question: Clarification on the Graves' disease candidate - Management confirmed that the decision to delay was due to idiosyncratic findings unrelated to on-target activity [32] Question: Details on prescriber engagement and patient demographics - Management noted that 95% of top priority prescribers have been engaged, with a mix of community and academic prescribers showing positive initial responses [33][36] Question: Demand dynamics between community and centers of excellence - Management highlighted that community practices are more nimble, leading to quicker adoption compared to academic centers [39] Question: Insights on Quick Start program and reimbursement - Management indicated that benefit verification is ongoing, with a goal to expedite the process while ensuring patients receive treatment [48][42] Question: Overview of launch experience and payer segments - Management reported a balanced mix of commercial, Medicare, and Medicaid patients, with positive feedback across all segments [53]
Crinetics Pharmaceuticals(CRNX) - 2025 Q3 - Quarterly Report
2025-11-06 21:25
Product Development and Approvals - PALSONIFY™ (paltusotine) was approved by the FDA on September 25, 2025, for the treatment of acromegaly, with a marketing authorization application under review by the EMA[88][89]. - Approximately 36,000 people in the U.S. are living with acromegaly, with 17,000 undiagnosed and 11,500 actively managed; 40% of actively managed patients are treatment naïve[88]. - Atumelnant showed significant clinical improvements in a Phase 2 study for congenital adrenal hyperplasia, with data expected early in 2026[92]. - The company expects to initiate a Phase 2/3 trial of atumelnant for ACTH-Dependent Cushing's Syndrome in the first half of 2026[92]. - The first patient for CRN09682, a candidate for treating neuroendocrine tumors, is expected to be enrolled in a Phase 1/2 study in Q4 2025[92]. Financial Performance - The company has not generated any product revenue during the quarter ended September 30, 2025, despite FDA approval of PALSONIFY[95][96]. - Revenues for the nine months ended September 30, 2025, were derived from licensing agreements, with no revenues from PALSONIFY sales[100]. - Revenues for the three months ended September 30, 2025, were $143,000, a 100% increase from $0 in the same period of 2024; revenues for the nine months ended September 30, 2025, were $1,535,000, a 48% increase from $1,039,000 in 2024[107]. Operating Expenses - Cumulative net losses have been incurred since inception, with expectations of increased operating expenses as product revenues grow[96]. - Research and development expenses primarily relate to the clinical development of paltusotine and atumelnant, with significant costs expected to continue[101]. - Research and development expenses increased by $28.6 million (46%) for the three months ended September 30, 2025, and by $73.4 million (42%) for the nine months ended September 30, 2025, compared to the prior year periods[108]. - Selling, general and administrative expenses rose by $26.4 million (102%) for the three months ended September 30, 2025, and by $66.1 million (92%) for the nine months ended September 30, 2025, compared to the prior year periods[112]. - The total operating expenses for the three months ended September 30, 2025, were $142.7 million, a 63% increase from $87.8 million in the same period of 2024; for the nine months ended September 30, 2025, total operating expenses were $384.6 million, a 57% increase from $245.1 million in 2024[107]. - Clinical trial expenses increased by $7.2 million (71%) for the three months ended September 30, 2025, and by $14.5 million (49%) for the nine months ended September 30, 2025, compared to the prior year periods[110]. - Contract manufacturing expenses rose by $3.0 million (43%) for the three months ended September 30, 2025, and by $7.2 million (38%) for the nine months ended September 30, 2025, compared to the prior year periods[110]. Net Loss and Cash Flow - The net loss for the three months ended September 30, 2025, was $130.1 million, a 69% increase from $76.8 million in the same period of 2024; for the nine months ended September 30, 2025, the net loss was $342.5 million, a 57% increase from $217.8 million in 2024[107]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $285.0 million, a 75% increase from $163.3 million in the same period of 2024[120]. - Net cash provided by investing activities increased significantly to $116.8 million for the nine months ended September 30, 2025, compared to a cash outflow of $32.7 million in 2024[120]. - Net cash provided by financing activities decreased by 97% to $14.6 million for the nine months ended September 30, 2025, down from $458.4 million in 2024[120]. Capital and Financing - The company plans to finance cash needs through equity offerings and collaborations until significant product revenues are generated[97]. - The company may need to raise substantial additional capital in the future to support ongoing and future product development[103]. - The company anticipates financing cash needs through equity offerings, debt financings, or collaborations, which may dilute existing stockholder interests[117]. - The company has entered into a Sales Agreement for an ATM Offering of up to $350.0 million, but no shares have been sold under this agreement as of the report date[118]. Cash and Investment Securities - As of September 30, 2025, cash and cash equivalents decreased by 58% to $110.9 million compared to $264.5 million as of December 31, 2024[115]. - Investment securities decreased by 10% to $981.4 million as of September 30, 2025, down from $1.1 billion as of December 31, 2024[115]. - The accumulated deficit increased by 36% to $1.3 billion as of September 30, 2025, compared to $952.1 million as of December 31, 2024[115]. Shareholder Information - As of October 28, 2025, the company had 94.9 million outstanding shares of common stock[119].
Crinetics Pharmaceuticals(CRNX) - 2025 Q3 - Quarterly Results
2025-11-06 21:20
Financial Performance - Revenues for Q3 2025 were $0.1 million, all derived from the paltusotine licensing agreement, compared to no revenues in Q3 2024[11] - The net loss for Q3 2025 was $130.1 million, compared to a net loss of $76.8 million in Q3 2024[11] - Crinetics' accumulated deficit reached $1.29 billion as of September 30, 2025[16] Expenses - Research and development expenses increased to $90.5 million in Q3 2025 from $61.9 million in Q3 2024, primarily due to a $10.9 million rise in personnel costs and a $10.2 million increase in clinical and manufacturing activities[11] - Selling, general and administrative expenses rose to $52.3 million in Q3 2025 from $25.9 million in Q3 2024, driven by a $10.2 million increase in personnel costs and a $12.0 million rise in outside services costs[11] - Cash, cash equivalents, and investments totaled $1.1 billion as of September 30, 2025, down from $1.4 billion as of December 31, 2024, with a projected cash burn of $340-370 million for 2025[11] Product Developments - Palsonify was approved by the FDA on September 25, 2025, for the treatment of adults with acromegaly, with over 95% of top priority healthcare providers contacted[5][11] - Approximately 95% of filled prescriptions for Palsonify are from switch patients, with 50% of prescriptions reimbursed[5] - Crinetics expects to randomize the first patients in the CAREFNDR Phase 3 trial of paltusotine in carcinoid syndrome in Q4 2025[6] - The company anticipates sharing glucocorticoid reduction data from the Phase 2 study of atumelnant in early 2026[6]
Crinetics Pharmaceuticals Reports Third Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-11-06 21:05
Core Insights - Crinetics Pharmaceuticals has successfully launched PALSONIFY (paltusotine) in the U.S. for treating acromegaly, receiving positive feedback from both patients and healthcare providers [2][6] - The company reported a net loss of $130.1 million for Q3 2025, an increase from a net loss of $76.8 million in Q3 2024, while revenues were $0.1 million, primarily from a licensing agreement [12][16] - Crinetics anticipates a cash burn of $340-370 million for 2025, with sufficient cash reserves to fund operations into 2029 [12][17] Product Launch and Market Response - PALSONIFY was approved by the FDA on September 25, 2025, as a first-line treatment for adults with acromegaly who have not responded adequately to surgery [6][10] - The launch has seen over 95% of top healthcare providers targeted, with 95% of filled prescriptions coming from patients switching from previous therapies [6][10] - Approximately 50% of filled prescriptions have received reimbursement, indicating a favorable payer landscape [6] Financial Performance - Revenues for Q3 2025 were $0.1 million, compared to no revenues in Q3 2024, with all revenues derived from a licensing agreement [12][16] - Research and development expenses rose to $90.5 million in Q3 2025 from $61.9 million in Q3 2024, driven by increased personnel and clinical activities [12][16] - Selling, general, and administrative expenses also increased to $52.3 million in Q3 2025 from $25.9 million in Q3 2024, reflecting growth and the commercial launch of PALSONIFY [12][16] Upcoming Milestones - Crinetics plans to initiate the CAREFNDR Phase 3 trial of paltusotine in carcinoid syndrome in Q4 2025 [6] - The company expects to randomize the first patients in the CALM-CAH Phase 3 study for congenital adrenal hyperplasia and the BALANCE-CAH Phase 2/3 study in pediatrics in Q4 2025 [6] - The first patient is anticipated to receive CRN09682 in a Phase 1/2 study in Q4 2025, targeting neuroendocrine tumors [6] Company Overview - Crinetics Pharmaceuticals focuses on developing novel therapeutics for endocrine diseases and related tumors, with a pipeline of over 10 programs [9][10] - The company is committed to transforming treatment through innovative science and has a core expertise in targeting G-protein coupled receptors [9][10]
Crinetics to Highlight Neuroendocrine Tumor Research Progress at the 2025 North American Neuroendocrine Tumor Society Annual Meeting
Globenewswire· 2025-10-23 12:00
Core Insights - Crinetics Pharmaceuticals is presenting new data on paltusotine, a novel SST2 agonist, at the NANETS 2025 meeting, highlighting its potential anti-tumor effects in treating carcinoid syndrome associated with neuroendocrine tumors (NETs) [1][2] - The Phase 2 study of paltusotine shows a promising one-year progression-free survival rate of 74% in patients with carcinoid syndrome [2][4] - Paltusotine is currently approved in the U.S. for treating acromegaly but is not yet approved for carcinoid syndrome [3][5] Company Overview - Crinetics Pharmaceuticals focuses on developing therapies for endocrine diseases and related tumors, with a strong emphasis on targeting G-protein coupled receptors (GPCRs) [8][9] - The company has a diverse pipeline with over 10 disclosed programs, including late-stage candidates for various endocrine conditions [9] Clinical Development - Paltusotine is in Phase 3 clinical development for carcinoid syndrome, with previous studies indicating significant reductions in common symptoms such as flushing and bowel movement frequency [5][6] - The upcoming presentations at NANETS will include details from the Phase 3 trial of paltusotine and a first-in-human study of the nonpeptide drug candidate CRN09682 [4][6]
Crinetics Pharmaceuticals Announces October 2025 Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Globenewswire· 2025-10-10 20:41
Core Insights - Crinetics Pharmaceuticals granted stock options and restricted stock units (RSUs) to 20 new non-executive employees as part of its 2021 Employment Inducement Incentive Award Plan, totaling 78,975 shares in stock options and 54,475 shares in RSUs [1][2] Company Overview - Crinetics Pharmaceuticals is a global pharmaceutical company focused on transforming the treatment of endocrine diseases and related tumors, emphasizing patient needs and targeting G-protein coupled receptors (GPCRs) with small molecules [3] Product Pipeline - The lead product, PALSONIFY™ (paltusotine), is the first oral treatment approved by the U.S. FDA for adults with acromegaly who have had inadequate surgical responses or for whom surgery is not an option. Paltusotine is also in clinical development for carcinoid syndrome associated with neuroendocrine tumors [4] - Crinetics has a deep pipeline with over 10 disclosed programs, including atumelnant, which is in late-stage development for congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome. Other discovery programs target various endocrine conditions such as Graves' disease, polycystic kidney disease, and GPCR-targeted oncology indications [4]