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Crinetics Pharmaceuticals Announces August 2025 Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Globenewswire· 2025-08-11 20:05
Core Points - 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 [1][2] - A total of 75,850 stock options and 53,400 RSUs were awarded, aimed at attracting talent to the company [1] - The stock options have an exercise price of $26.85 per share, equal to the closing price on August 8, 2025, and will vest over four years [2] Company Overview - Crinetics Pharmaceuticals is a clinical-stage pharmaceutical company focused on developing therapeutics for endocrine diseases and related tumors [3] - The lead candidate, PALSONIFY (paltusotine), is in clinical development for acromegaly and carcinoid syndrome associated with neuroendocrine tumors [3] - Other drug candidates include Atumelnant, targeting congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome, with a focus on orally delivered small molecules [3]
Crinetics (CRNX) Q2 Revenue Jumps 150%
The Motley Fool· 2025-08-08 02:57
Core Insights - Crinetics Pharmaceuticals reported a GAAP revenue of $1.0 million for Q2 2025, exceeding the consensus estimate of $0.61 million, but the GAAP net loss per share widened to $(1.23), larger than the anticipated $(1.08) per share, due to increased R&D and administrative expenses [1][5][6] Financial Performance - GAAP revenue for Q2 2025 was $1.0 million, a 150% increase from $0.4 million in Q2 2024 [2] - GAAP net loss per share was $(1.23), a 30.9% increase from $(0.94) in Q2 2024 [2] - Research and Development expenses rose to $80.3 million, up 37.8% from $58.3 million in Q2 2024 [2] - Selling, General & Administrative expenses doubled to $49.8 million from $24.8 million in Q2 2024 [2] - The company reported a net loss of $(115.6) million for the quarter, compared to $(74.1) million in Q2 2024 [1][6] Product Pipeline and Development - The company focuses on developing oral therapies for rare endocrine diseases, with lead products including paltusotine for acromegaly and carcinoid syndrome, and atumelnant for congenital adrenal hyperplasia and Cushing's disease [3][11] - Paltusotine's New Drug Application (NDA) review is on track, with a target FDA decision date of September 25, 2025 [7] - Atumelnant is in Phase 2 trials for CAH, with Phase 3 studies planned for both adult and pediatric populations [8] Strategic Initiatives - The company is preparing for its first commercial drug launch, focusing on regulatory approvals, clinical trial effectiveness, and building relationships with healthcare professionals [4][10] - The CrinetiCare platform is being established to support patient outreach and education ahead of the potential launch of paltusotine [10] Cash Position and Future Outlook - As of June 30, 2025, the company had $1.2 billion in cash, cash equivalents, and investments, expected to fund operations into 2029 [15] - Full-year cash use for 2025 is estimated between $340 to $370 million, reflecting readiness for commercial launch and ongoing late-stage trials [15] - Management did not provide formal guidance for future revenue or earnings, focusing instead on the upcoming FDA decision for paltusotine [14]
Crinetics Pharmaceuticals(CRNX) - 2025 Q2 - Earnings Call Transcript
2025-08-07 21:30
Financial Data and Key Metrics Changes - The company recognized $1 million in revenue from licensing and supply agreements with its Japanese partner SKK for the second quarter [33] - Research and development expenses increased to $80.3 million in Q2 from $76.2 million in Q1, reflecting continued investment in clinical programs [33] - Selling, general and administrative expenses rose to $49.8 million in Q2 from $35.5 million in Q1, primarily due to investments in commercial capabilities [33] - The company ended the quarter with $1.2 billion in cash, cash equivalents, and investments [34] - The high end of the guidance for net cash used in operations in 2025 was lowered to $370 million from $380 million, reflecting greater precision on clinical timelines [35] Business Line Data and Key Metrics Changes - The company is preparing for the launch of Palsonify, its treatment for acromegaly, with a strong focus on building a commercial team and engaging with healthcare professionals [13][16] - Market research indicates that healthcare professionals view Palsonify as the preferred therapy among newly diagnosed patients due to its rapid reduction of IGF-1 levels [17] - There are approximately 500 newly diagnosed patients per year who are candidates for pharmaceutical therapy, and 11,000 currently diagnosed patients with high unmet needs [17] Market Data and Key Metrics Changes - The company is actively engaging with the patient community and healthcare professionals to shape its commercial strategy for Palsonify [8][20] - There is a significant opportunity to activate patients who have discontinued therapy or are dissatisfied with current treatment options, as nearly 80% of patients on injectable SRLs did not persist with treatment [19] - The company believes there are at least 17,000 undiagnosed patients who could benefit from treatment [20] Company Strategy and Development Direction - The company aims to transform the lives of patients with acromegaly through the anticipated launch of Palsonify and is focused on expanding the market by bringing in previously untreated patients [20] - The company is also advancing multiple pivotal programs, including trials for carcinoid syndrome and congenital adrenal hyperplasia [10][27] - The commercial strategy includes a disease state education campaign and patient support hub to increase awareness and empower patients [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the NDA review process for paltusotine, anticipating approval in September [6][25] - The company is optimistic about the potential of Palsonify to become the preferred treatment for the acromegaly community, supported by positive feedback from healthcare professionals [22] - Management acknowledged that patient engagement and education will be crucial for driving adoption post-launch [20][105] Other Important Information - The company is preparing for a potential launch in Europe in 2026 and is actively working with payers to ensure access pathways for Palsonify [23][22] - The company has made significant progress in its clinical pipeline, including ongoing studies for adamelin in congenital adrenal hyperplasia [29][30] Q&A Session Summary Question: How does the launch of Neurocrine's product affect enrollment for Phase III studies? - Management believes the launch raises awareness of the unmet need and positively impacts enrollment, particularly as most enrollment occurs outside the U.S. [40][42] Question: What is the timeline for IND submissions for TSH and SST3 agonists? - The company is targeting the end of the year for IND submissions for both molecules [46][47] Question: What is the comfort level with current consensus numbers for the paltusotine launch? - Management refrained from commenting on consensus numbers but expressed confidence in launch preparations [50][52] Question: What are the expectations around placebo response in the global CAH Phase III study? - Management does not expect a high placebo response rate and believes the trial is well-powered [55][56] Question: Will pricing for Palsonify be discussed at the time of approval? - Management indicated that pricing discussions will occur at the appropriate time post-approval, emphasizing the positive reception of the value proposition by payers [59][62] Question: How many patients are currently in the open-label extension for Palsonify? - Management noted that the open-label extension is ongoing in multiple countries, and decisions regarding patient transitions to commercial treatment will depend on regulatory outcomes [69][74] Question: What are the potential endpoints for Cushing's disease trials? - The primary endpoint will be normalization of 24-hour urine free cortisol excretion, with rapid normalization observed in initial trials [99][100] Question: How does the company plan to manage the progression towards NDA submission for atomelanit? - The company plans to treat each study as a distinct submission and will not hold one until the other is completed [121][123] Question: Is there a market for surgically naive patients for paltusotine? - While there is an unmet need, the company is not actively considering that segment at this time [127]
Crinetics Pharmaceuticals(CRNX) - 2025 Q2 - Quarterly Report
2025-08-07 20:39
[PART I – FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) This section presents the company's unaudited condensed consolidated financial statements and management's discussion and analysis of financial condition and results of operations [Item 1. Condensed Consolidated Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) This section presents the unaudited condensed consolidated financial statements, including the balance sheets, statements of operations and comprehensive loss, statements of stockholders' equity, and statements of cash flows, along with detailed notes explaining the company's accounting policies, financial instruments, lease obligations, revenue recognition, equity activities, and investments [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This statement provides a snapshot of the company's financial position, detailing assets, liabilities, and equity at specific points in time Condensed Consolidated Balance Sheets (in thousands) | Metric | June 30, 2025 (Unaudited) | December 31, 2024 | | :-------------------------------- | :-------------------------- | :------------------ | | Cash and cash equivalents | $53,726 | $264,545 | | Investment securities | $1,142,634 | $1,089,524 | | Total current assets | $1,217,264 | $1,375,388 | | Total assets | $1,289,574 | $1,434,592 | | Total current liabilities | $68,396 | $59,684 | | Total liabilities | $118,048 | $109,787 | | Total stockholders' equity | $1,171,526 | $1,324,805 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This statement reports the company's revenues, expenses, and net loss over specific periods, along with comprehensive loss Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except per share data) | Metric | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenues | $1,031 | $399 | $1,392 | $1,039 | | Research and development | $80,301 | $58,344 | $156,541 | $111,685 | | Selling, general and administrative | $49,842 | $24,838 | $85,368 | $45,666 | | Total operating expenses | $130,143 | $83,182 | $241,909 | $157,351 | | Loss from operations | $(129,112) | $(82,783) | $(240,517) | $(156,312) | | Interest income | $13,455 | $8,741 | $28,289 | $16,061 | | Net loss | $(115,637) | $(74,055) | $(212,411) | $(140,985) | | Net loss per share — basic and diluted | $(1.23) | $(0.94) | $(2.27) | $(1.86) | | Comprehensive loss | $(116,018) | $(74,395) | $(211,753) | $(142,152) | [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) This statement details changes in the company's equity accounts, including common stock, paid-in capital, and accumulated deficit - Accumulated deficit increased from **$(952,110)K** at January 1, 2025, to **$(1,164,521)K** at June 30, 2025, primarily due to the net loss of **$(212,411)K**[16](index=16&type=chunk) - Common stock and paid-in capital increased by **$58,586K** from January 1, 2025, to June 30, 2025, driven by stock-based compensation (**$46,602K**) and exercise of stock options (**$8,981K**)[16](index=16&type=chunk) - Total stockholders' equity decreased from **$1,324,805K** at January 1, 2025, to **$1,171,526K** at June 30, 2025[16](index=16&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This statement summarizes the cash inflows and outflows from operating, investing, and financing activities over specific periods Condensed Consolidated Statements of Cash Flows (in thousands) | Metric | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :------------------------------------ | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(174,303) | $(100,500) | | Net cash used in investing activities | $(48,008) | $(53,332) | | Net cash provided by financing activities | $11,492 | $401,097 | | Net change in cash, cash equivalents and restricted cash | $(210,819) | $247,265 | | Cash, cash equivalents and restricted cash at end of period | $55,026 | $303,462 | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations of the company's accounting policies, financial instruments, lease obligations, revenue recognition, equity activities, and investments [Note 1. Organization and Basis of Presentation](index=7&type=section&id=Note%201.%20Organization%20and%20Basis%20of%20Presentation) This note outlines the company's business, financial condition, and future funding expectations - Crinetics Pharmaceuticals is a clinical-stage company focused on novel therapeutics for endocrine diseases and endocrine-related tumors, with lead product candidates paltusotine and atumelnant[22](index=22&type=chunk) - The company has an accumulated deficit of **$1.2 billion** as of June 30, 2025, but believes its **$1.2 billion** in cash, cash equivalents, and investment securities are sufficient to meet funding requirements for at least the next 12 months[27](index=27&type=chunk)[28](index=28&type=chunk) - The company expects to incur net losses for the foreseeable future and anticipates needing to raise substantial additional capital through equity offerings, debt financings, or collaborations[29](index=29&type=chunk) [Note 2. Investment Securities](index=9&type=section&id=Note%202.%20Investment%20Securities) This note details the company's available-for-sale investment securities, including fair values and unrealized gains/losses Available-for-Sale Investment Securities (in thousands) | Metric | June 30, 2025 Fair Market Value | December 31, 2024 Fair Market Value | | :-------------------------------- | :------------------------------ | :-------------------------------- | | U.S. government obligations | $592,615 | $543,344 | | Agency obligations | $51,450 | $57,931 | | Corporate debt securities | $498,569 | $488,249 | | Total | $1,142,634 | $1,089,524 | - As of June 30, 2025, total gross unrealized gains were **$1,784K** and total gross unrealized losses were **$(135)K**[36](index=36&type=chunk) - The company determined that decreases in fair value are attributable to changes in interest rates, not credit quality, and does not intend to sell before recovery of amortized cost basis, resulting in no allowances for credit losses[38](index=38&type=chunk) [Note 3. Fair Value Measurements](index=10&type=section&id=Note%203.%20Fair%20Value%20Measurements) This note describes the valuation methodologies and inputs used for financial assets measured at fair value Financial Assets Measured at Fair Value (in thousands) | Category | June 30, 2025 Total | December 31, 2024 Total | | :-------------------------------- | :------------------ | :------------------ | | Cash equivalents | $45,022 | $254,430 | | Investment securities | $1,142,634 | $1,089,524 | | Other non-current assets (Deferred compensation plan) | $2,345 | $829 | | Total assets measured at fair value | $1,190,001 | $1,344,783 | - Fair value measurements primarily utilize Level 1 (e.g., money market funds, U.S. government obligations) and Level 2 inputs (e.g., agency obligations, corporate debt securities), with no Level 3 assets[40](index=40&type=chunk) [Note 4. Balance Sheet Details](index=10&type=section&id=Note%204.%20Balance%20Sheet%20Details) This note provides a breakdown of specific balance sheet accounts, including prepaid expenses and accrued liabilities Prepaid Expenses and Other Assets (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Prepaid clinical costs | $12,208 | $6,842 | | Interest receivable | $8,381 | $8,310 | | Prepaid subscriptions | $5,043 | $2,561 | | Deferred compensation plan | $2,345 | $829 | | Total prepaid expenses and other assets | $35,342 | $23,648 | Accounts Payable and Accrued Expenses (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Accounts payable | $11,325 | $5,853 | | Accrued outside services and professional fees | $11,615 | $5,572 | | Accrued clinical trial costs | $7,939 | $3,076 | | Total | $38,086 | $21,469 | [Note 5. Operating Leases](index=11&type=section&id=Note%205.%20Operating%20Leases) This note outlines the company's operating lease obligations, costs, and key lease terms Future Minimum Payments Under Non-Cancellable Operating Leases (in thousands) | Year ending December 31, | Minimum Payments | | :----------------------- | :--------------- | | 2025 (six months) | $3,524 | | 2026 | $6,795 | | 2027 | $6,999 | | 2028 | $7,209 | | 2029 | $7,425 | | Thereafter | $43,550 | | Total future minimum lease payments | $75,502 | | Total operating lease liabilities | $49,936 | - Operating lease cost was **$4.4 million** for the six months ended June 30, 2025, compared to **$4.3 million** for the same period in 2024[46](index=46&type=chunk) - As of June 30, 2025, the weighted-average remaining lease term was **9.8 years** and the weighted-average discount rate was **8.6%**[47](index=47&type=chunk) [Note 6. Commitments and Contingencies](index=12&type=section&id=Note%206.%20Commitments%20and%20Contingencies) This note discusses the company's legal claims and other commitments, assessing their potential financial impact - The company does not expect that the resolution of ordinary course legal claims and suits will have a material adverse effect on its financial position or results of operations[49](index=49&type=chunk) [Note 7. Revenue Recognition](index=12&type=section&id=Note%207.%20Revenue%20Recognition) This note details the sources and recognition of the company's revenues from license and supply agreements - Revenues for the three and six months ended June 30, 2025, were **$0.6 million** and **$1.0 million**, respectively, recognized from the Sanwa License[53](index=53&type=chunk) - An additional **$0.4 million** and **$0.1 million** in revenues were recognized from the Sanwa Clinical Supply Agreement for the three and six months ended June 30, 2025, respectively[54](index=54&type=chunk) - The company granted Loyal an exclusive license for CRN01941 for veterinary use, receiving a **$0.1 million** upfront payment and Loyal preferred stock valued at **$2.0 million**, with no revenue recognized to date from this agreement[55](index=55&type=chunk)[56](index=56&type=chunk) [Note 8. Stockholders' Equity](index=13&type=section&id=Note%208.%20Stockholders'%20Equity) This note describes significant changes in stockholders' equity, including capital raises and share issuances - In March 2024, the company completed a private placement of **8,333,334 common shares**, generating approximately **$335.5 million** in net proceeds[57](index=57&type=chunk) - In October 2024, a public offering of **11,500,000 common shares** generated approximately **$542.8 million** in net proceeds[58](index=58&type=chunk) - The 2024 ATM Offering allows for the sale of up to **$350.0 million** of common stock, but no shares have been issued under it during the three and six months ended June 30, 2025[60](index=60&type=chunk) [Note 9. Equity Incentive Plans](index=13&type=section&id=Note%209.%20Equity%20Incentive%20Plans) This note provides details on the company's equity incentive plans, available shares, and stock-based compensation expense - As of June 30, 2025, **2,379,126 shares** were available for future issuance under the 2021 Inducement Plan, **5,232,485 shares** under the 2018 Incentive Award Plan, and **2,865,513 shares** under the ESPP[61](index=61&type=chunk)[62](index=62&type=chunk)[64](index=64&type=chunk) - Stock-based compensation expense totaled **$46,602K** for the six months ended June 30, 2025, an increase from **$32,394K** in the prior year period[69](index=69&type=chunk) Unrecognized Stock-Based Compensation Expense (in thousands) | Award Type | Unrecognized Stock-Based Compensation Expense | | :----------------------- | :------------------------------------------ | | Stock option awards | $153,517 | | RSU awards | $67,952 | | ESPP | $6,839 | [Note 10. Investment in Radionetics](index=15&type=section&id=Note%2010.%20Investment%20in%20Radionetics) This note describes the company's equity investment in Radionetics Oncology, including its valuation and strategic developments - The company holds a **25% equity ownership** in Radionetics Oncology, Inc. as of June 30, 2025, accounted for under the equity method, with the investment asset previously written down to zero[73](index=73&type=chunk) - Radionetics formed a strategic partnership with Eli Lilly and Company in July 2024, receiving a **$140 million** upfront payment and granting Lilly an exclusive option to acquire Radionetics for **$1.0 billion**[72](index=72&type=chunk) - No equity method losses were recorded for the three and six months ended June 30, 2025, compared to **$0.5 million** in losses during the same period in 2024[73](index=73&type=chunk) [Note 11. Segment Reporting](index=15&type=section&id=Note%2011.%20Segment%20Reporting) This note clarifies that the company operates in a single reportable segment and provides a breakdown of segment expenses - The company operates in a single reportable segment, with performance assessed based on condensed consolidated net loss[75](index=75&type=chunk) Segment Expenses (Six months ended June 30, 2025, in thousands) | Category | Amount | | :-------------------------------- | :------- | | Paltusotine R&D expenses | $(30,653) | | Atumelnant R&D expenses | $(18,194) | | Early research and development programs | $(16,643) | | Research and development personnel expenses | $(53,673) | | Selling, general and administrative expenses | $(85,368) | | Segment and consolidated net loss | $(212,411) | [Note 12. Net Loss Per Share](index=16&type=section&id=Note%2012.%20Net%20Loss%20Per%20Share) This note explains the calculation of basic and diluted net loss per share, including anti-dilutive securities - Basic and diluted net loss per share were both **$(2.27)** for the six months ended June 30, 2025, as potentially dilutive securities were anti-dilutive[12](index=12&type=chunk)[77](index=77&type=chunk) - Potentially dilutive securities not included in diluted EPS calculation totaled **17,623K common stock equivalent shares** as of June 30, 2025, comprising stock options, unvested RSUs, and estimated ESPP shares[78](index=78&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and operational results, highlighting key pipeline updates for paltusotine and atumelnant, progress in early-stage research, and an in-depth analysis of revenues, operating expenses, and liquidity [Forward Looking Statements](index=17&type=section&id=Forward%20Looking%20Statements) This section discusses statements regarding future results, business strategy, product approvals, and R&D costs, which are subject to risks and uncertainties - The report contains forward-looking statements regarding future results, business strategy, product approvals, and R&D costs, which are subject to risks and uncertainties[80](index=80&type=chunk) [Overview](index=17&type=section&id=Overview) This section provides an overview of Crinetics Pharmaceuticals, a clinical-stage company focused on endocrine diseases and tumors - Crinetics Pharmaceuticals is a clinical-stage company focused on discovering, developing, and commercializing novel therapeutics for endocrine diseases and endocrine-related tumors[81](index=81&type=chunk) - Lead product candidate, paltusotine, is under FDA and European regulatory review for acromegaly and in clinical development for carcinoid syndrome[81](index=81&type=chunk) - Second product candidate, atumelnant, is in clinical development for congenital adrenal hyperplasia (CAH) and ACTH-Dependent Cushing's Syndrome (ADCS)[81](index=81&type=chunk) [Key Pipeline Updates](index=17&type=section&id=Key%20Pipeline%20Updates) This section highlights significant developments in the company's product pipeline, including paltusotine and atumelnant - Paltusotine's U.S. FDA review for PALSONIFY™ in acromegaly continues, with an estimated **11,000 addressable patients** and **500 newly diagnosed annually** in the U.S[84](index=84&type=chunk) - Atumelnant's Phase 2 TouCAHn study in CAH reported positive results, showing rapid, substantial, and sustained statistically significant reduction in A4 levels, with a Phase 3 CALM-CAH study designed to normalize A4 levels[84](index=84&type=chunk) - IND clearance was received for CRN09682, the first candidate from the nonpeptide drug conjugate (NDC) platform, with a Phase 1/2 dose escalation study planned for SST2-positive neuroendocrine tumors[87](index=87&type=chunk) [Financial operations overview](index=19&type=section&id=Financial%20operations%20overview) This section summarizes the company's financial operations, including resource allocation, cumulative losses, and future funding needs - The company has devoted substantially all resources to drug discovery, preclinical/clinical trials, and intellectual property, and has not generated any product sales to date[86](index=86&type=chunk) - Cumulative net losses and negative cash flows from operations have been incurred since inception, with an accumulated deficit of **$1.2 billion** as of June 30, 2025[88](index=88&type=chunk) - Expenses and operating losses are expected to increase substantially, necessitating future financing through equity offerings, debt, or collaborations[88](index=88&type=chunk)[89](index=89&type=chunk) [Revenues](index=21&type=section&id=Revenues) This section details the company's revenue sources, primarily from research grants and license agreements - Revenues are primarily derived from research grants and license agreements, specifically the Sanwa License and Sanwa Clinical Supply Agreement[90](index=90&type=chunk) Revenues (in thousands) | Period | 2025 | 2024 | Change ($) | Change (%) | | :----------------------- | :----- | :----- | :--------- | :--------- | | Three months ended June 30 | $1,031 | $399 | $632 | 158% | | Six months ended June 30 | $1,392 | $1,039 | $353 | 34% | - The New Drug Application (NDA) for PALSONIFY™ for acromegaly was accepted by the FDA, with a Prescription Drug User Fee Act (PDUFA) Target Action Date of September 25, 2025[90](index=90&type=chunk) [Research and development](index=21&type=section&id=Research%20and%20development) This section analyzes the company's research and development expenses, driven by clinical program advancements and portfolio expansion - Research and development expenses increased by **$44.9 million (40%)** to **$156.5 million** for the six months ended June 30, 2025, compared to the prior year period[98](index=98&type=chunk)[99](index=99&type=chunk) - The increase was primarily due to higher headcount, increased manufacturing activities, and rising clinical costs driven by the advancement of clinical programs (paltusotine, atumelnant) and expansion of the preclinical portfolio[99](index=99&type=chunk)[102](index=102&type=chunk) Research and Development Expenses by Program (Six months ended June 30, in thousands) | Program | 2025 | 2024 | Change ($) | Change (%) | | :-------------------------------- | :------- | :------- | :--------- | :--------- | | Paltusotine | $30,653 | $25,419 | $5,234 | 21% | | Atumelnant | $18,194 | $8,962 | $9,232 | 103% | | Early research and development programs | $16,643 | $11,873 | $4,770 | 40% | | Personnel expenses | $53,673 | $36,586 | $17,087 | 47% | | Stock-based compensation | $24,918 | $19,056 | $5,862 | 31% | [Selling, general and administrative](index=23&type=section&id=Selling,%20general%20and%20administrative) This section examines the company's selling, general and administrative expenses, influenced by personnel and pre-commercialization costs - Selling, general and administrative expenses increased by **$39.7 million (87%)** to **$85.4 million** for the six months ended June 30, 2025, compared to the prior year period[98](index=98&type=chunk)[103](index=103&type=chunk) - This increase was primarily driven by higher personnel expenses (**$20.0 million** increase, including **$8.3 million** in stock-based compensation) and increased outside services (**$16.0 million** increase) to support overall growth and the planned commercial launch of PALSONIFY™[103](index=103&type=chunk) [Critical Accounting Estimates](index=23&type=section&id=Critical%20Accounting%20Estimates) This section confirms no material changes to the company's critical accounting estimates since the prior annual report - There have been no material changes to the company's critical accounting estimates since the Annual Report on Form 10-K for the year ended December 31, 2024[97](index=97&type=chunk) [Results of Operations](index=25&type=section&id=Results%20of%20Operations) This section summarizes the company's financial performance, including revenues, operating expenses, and net loss over specified periods Summary of Results of Operations (in thousands) | Metric | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenues | $1,031 | $399 | $1,392 | $1,039 | | Total operating expenses | $130,143 | $83,182 | $241,909 | $157,351 | | Loss from operations | $(129,112) | $(82,783) | $(240,517) | $(156,312) | | Other income, net | $13,475 | $8,728 | $28,106 | $15,797 | | Net loss | $(115,637) | $(74,055) | $(212,411) | $(140,985) | - Net loss increased by **56%** for the three months and **51%** for the six months ended June 30, 2025, compared to the prior year periods[98](index=98&type=chunk) - Other income, net, increased by **54%** and **78%** for the three and six months ended June 30, 2025, respectively, primarily due to increased income from investment securities[98](index=98&type=chunk)[104](index=104&type=chunk) [Liquidity and Capital Resources](index=27&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's financial liquidity and capital resources, including cash, investments, and future funding requirements Financial Condition Summary (in thousands) | Metric | June 30, 2025 | December 31, 2024 | $ Change | % Change | | :------------------------------------ | :------------ | :---------------- | :--------- | :--------- | | Cash and cash equivalents | $53,726 | $264,545 | $(210,819) | (80)% | | Investment securities | $1,142,634 | $1,089,524 | $53,110 | 5% | | Cash, cash equivalents and investment securities | $1,196,360 | $1,354,069 | $(157,709) | (12)% | | Working capital | $1,148,868 | $1,315,704 | $(166,836) | (13)% | | Accumulated deficit | $(1,164,521) | $(952,110) | $(212,411) | 22% | - Existing capital resources, including **$1.2 billion** in cash, cash equivalents, and investment securities, are believed sufficient to satisfy funding requirements for at least the next twelve months[105](index=105&type=chunk) - Net cash used in operating activities increased by **73%** to **$(174.3) million** for the six months ended June 30, 2025, primarily due to higher net loss, personnel costs, R&D expenses, and pre-commercialization costs[111](index=111&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section refers to the company's Annual Report on Form 10-K for a detailed discussion of market risks, noting no material changes since December 31, 2024 - No material changes to market risks have occurred since December 31, 2024[113](index=113&type=chunk) [Item 4. Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the effectiveness of disclosure controls and procedures as of June 30, 2025, concluding they were effective at a reasonable assurance level - Disclosure controls and procedures were evaluated and deemed effective as of June 30, 2025, at the reasonable assurance level[115](index=115&type=chunk) - No material change in internal control over financial reporting occurred during the most recent fiscal quarter[116](index=116&type=chunk) [PART II — OTHER INFORMATION](index=31&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) This section provides additional disclosures on legal proceedings, risk factors, equity sales, and other relevant corporate information [Item 1. Legal Proceedings](index=31&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings, though it may be subject to ordinary course claims, which are not expected to have a material adverse effect - The company is not currently involved in any material legal proceedings[119](index=119&type=chunk) - Claims incident to the ordinary course of business are not expected to have a material adverse effect on financial position or results of operations[119](index=119&type=chunk) [Item 1A. Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2024 - No material changes to the risk factors set forth in Part I, Item 1A of the Annual Report on Form 10-K for the year ended December 31, 2024[120](index=120&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=31&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report during the period - No unregistered sales of equity securities or use of proceeds occurred during the period[121](index=121&type=chunk) [Item 3. Defaults Upon Senior Securities](index=31&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities during the period - No defaults upon senior securities were reported[122](index=122&type=chunk) [Item 4. Mine Safety Disclosures](index=31&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Mine safety disclosures are not applicable to the company's operations - Mine Safety Disclosures are not applicable to the registrant[123](index=123&type=chunk) [Item 5. Other Information](index=31&type=section&id=Item%205.%20Other%20Information) This section details Rule 10b5-1 trading plan activities by company directors and officers, including terminations and adoptions of plans with specified share amounts and durations Rule 10b5-1 Trading Plan Activities (May-June 2025) | Name | Title of Director or Officer | Action | Date of Action | Duration of Plan | Total Shares of Common Stock to be Sold | | :--- | :--- | :--- | :--- | :--- | :--- | | Dana Pizzuti | Chief Medical and Development Officer | Termination of 10b5-1 plan | May 20, 2025 | January 3, 2025 - December 31, 2025 | Up to 70,000 shares | | Dana Pizzuti | Chief Medical and Development Officer | Adoption of 10b5-1 plan | May 21, 2025 | August 20, 2025 - September 2, 2026 | Up to 96,492 shares | | Isabel Kalofonos | Chief Commercial Officer | Adoption of 10b5-1 plan | June 7, 2025 | January 1, 2026 - December 19, 2026 | Up to 12,500 shares | [Item 6. Exhibits](index=32&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Quarterly Report on Form 10-Q, including organizational documents, certifications, and XBRL-related files - The report includes certifications from the Chief Executive Officer and Chief Financial Officer (Exhibits 31.1, 31.2, 32.1) and Inline XBRL documents (Exhibits 101.INS, 101.SCH, 104)[127](index=127&type=chunk)
Crinetics Pharmaceuticals(CRNX) - 2025 Q2 - Quarterly Results
2025-08-07 20:38
Company Overview and Business Update Crinetics Pharmaceuticals advances PALSONIFY™ regulatory review, progresses atumelnant development, and maintains a strong financial position [Executive Summary](index=1&type=section&id=Executive%20Summary) Crinetics Pharmaceuticals reported Q2 2025 financial results, highlighting significant progress towards becoming a fully-integrated, commercial-stage company - Crinetics is making significant progress towards becoming a fully-integrated, commercial-stage company, with regulatory and commercial preparations for PALSONIFY™ (paltusotine) on track[3](index=3&type=chunk) - The New Drug Application (NDA) for PALSONIFY™ (paltusotine) has a PDUFA target action date of **September 25, 2025**[1](index=1&type=chunk) - The company holds **$1.2 billion** in cash, cash equivalents, and investment securities as of June 30, 2025, anticipated to provide a financial runway into **2029**[1](index=1&type=chunk) [Recent Highlights](index=1&type=section&id=Recent%20Highlights) Recent highlights include the ongoing review of paltusotine's NDA for acromegaly, validation of its Marketing Authorization Application (MAA) by the EMA, and continued progress in the global development program for atumelnant - The review process for paltusotine's New Drug Application (NDA) for acromegaly remains on track with consistent and productive engagement with the FDA[4](index=4&type=chunk) - Paltusotine's Marketing Authorization Application (MAA) for acromegaly was validated by the European Medicines Agency (EMA), with a potential decision in the **first half of 2026**[4](index=4&type=chunk) - Enrollment for Cohort 4 of the adult Phase 2 study for atumelnant has been completed, with data expected **early in 2026**[4](index=4&type=chunk) - Crinetics presented eight abstracts from its novel clinical development programs, including paltusotine, atumelnant, and CRN12755, at the Endocrine Society's Annual Meeting, ENDO 2025[7](index=7&type=chunk) [Key Upcoming Milestones](index=2&type=section&id=Key%20Upcoming%20Milestones) Upcoming milestones include the FDA PDUFA date for paltusotine in September 2025, initiation of multiple Phase 3 trials for paltusotine (carcinoid syndrome) and atumelnant (adult and pediatric CAH) in H2 2025, and the start of a Phase 1/2 study for CRN09682 - FDA PDUFA target action date of **September 25, 2025**, for paltusotine NDA for the treatment of acromegaly[7](index=7&type=chunk) - Crinetics expects to initiate the CAREFNDR Phase 3 trial of paltusotine in carcinoid syndrome in the **second half of 2025**[7](index=7&type=chunk) - Crinetics expects to initiate the CALM-CAH Phase 3 study in adults with CAH and the BALANCE-CAH Phase 2/3 study in pediatrics in the **second half of 2025**[7](index=7&type=chunk) - Initiation of a Phase 2/3 study for atumelnant in ACTH-dependent Cushing's syndrome is expected in the **first half of 2026**[7](index=7&type=chunk) - Crinetics expects to initiate a Phase 1/2 dose escalation study for CRN09682, the first candidate from the nonpeptide drug conjugate (NDC) platform, for SST2-positive neuroendocrine tumors and other SST2-expressing solid tumors[7](index=7&type=chunk) Second Quarter 2025 Financial Results Crinetics reported increased Q2 2025 revenues and higher operating expenses, resulting in a larger net loss, but maintains a strong cash position [Financial Performance Overview](index=2&type=section&id=Financial%20Performance%20Overview) Crinetics reported increased revenues for Q2 2025, primarily from licensing agreements, but significantly increased operating expenses led to a higher net loss compared to the prior year Revenues (in thousands) | Metric | Q2 2025 | Q2 2024 | YoY Change | | :------------------------ | :--------------------- | :--------------------- | :--------- | | Revenues | $1,031 | $399 | +158.4% | Operating Expenses (in thousands) | Metric | Q2 2025 | Q2 2024 | YoY Change | | :------------------------- | :--------------------- | :--------------------- | :--------- | | Research and development | $80,301 | $58,344 | +37.6% | | Selling, general and administrative | $49,842 | $24,838 | +100.7% | - Increase in R&D expenses was primarily due to a **$9.6 million** increase in personnel costs and a **$7.9 million** increase in clinical and manufacturing activities costs, driven by clinical program advancement and preclinical portfolio expansion[7](index=7&type=chunk) - Increase in SG&A expenses was primarily driven by a **$12.0 million** increase in personnel costs (due to headcount increase) and a **$10.3 million** increase in outside services costs for commercial planning for PALSONIFY™[7](index=7&type=chunk) Net Loss (in thousands) | Metric | Q2 2025 | Q2 2024 | YoY Change | | :-------- | :--------------------- | :--------------------- | :--------- | | Net loss | $(115,637) | $(74,055) | +56.1% | [Financial Position and Outlook](index=2&type=section&id=Financial%20Position%20and%20Outlook) As of June 30, 2025, Crinetics held $1.2 billion in cash, cash equivalents, and investments, projecting these resources will fund operations into 2029, with an updated anticipated cash used in operations for 2025 between $340 million and $370 million Cash, Cash Equivalents and Investments (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :----------------------------------- | :------------ | :---------------- | | Cash, cash equivalents and investments | $1,196,360 | $1,354,069 | - Based on current projections, Crinetics expects its cash, cash equivalents, and investments to be sufficient to fund its current operating plan into **2029**[7](index=7&type=chunk)[8](index=8&type=chunk) - For 2025, the company now anticipates cash used in operations to be between **$340 million** and **$370 million**[8](index=8&type=chunk) Corporate Information This section covers Q2 2025 conference call details, Crinetics Pharmaceuticals' therapeutic focus, and forward-looking statement disclaimers [Conference Call and Webcast Details](index=3&type=section&id=Conference%20Call%20and%20Webcast%20Details) Management hosted a live conference call and webcast on August 7, 2025, at 4:30 p.m. ET to discuss the financial results and business update - Management held a live conference call and webcast on **Thursday, August 7, 2025, at 4:30 p.m. ET**[9](index=9&type=chunk) - Access details for the conference call were **1-833-470-1428** (domestic) or **1-404-975-4839** (international) with Access Code **899803**[9](index=9&type=chunk) [About Crinetics Pharmaceuticals](index=3&type=section&id=About%20Crinetics%20Pharmaceuticals) Crinetics Pharmaceuticals is a clinical-stage company focused on discovering, developing, and commercializing novel therapeutics for endocrine diseases and related tumors - Crinetics Pharmaceuticals is a clinical-stage company focused on the discovery, development, and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors[10](index=10&type=chunk) - PALSONIFY (paltusotine) is the lead investigational once-daily, oral, selective somatostatin receptor type 2 (SST2) nonpeptide agonist in clinical development for acromegaly and carcinoid syndrome[10](index=10&type=chunk) - Atumelnant is currently in development for congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome[10](index=10&type=chunk) - The company's pipeline includes additional discovery programs for hyperparathyroidism, polycystic kidney disease, Graves' disease, diabetes, obesity, and GPCR-targeted oncology indications[10](index=10&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section contains a standard disclaimer regarding forward-looking statements, emphasizing that actual results may differ materially from projections due to various risks and uncertainties - The press release contains forward-looking statements regarding clinical development plans, regulatory timelines, commercial launch plans, therapeutic potential, and financial runway[11](index=11&type=chunk) - Key risks and uncertainties include potential changes in reported data, regulatory authorities disagreeing with interpretations, inability to obtain/enforce intellectual property rights, geopolitical disruptions, unexpected adverse side effects, dependence on third parties, and the timing/outcome of research and development[11](index=11&type=chunk)[12](index=12&type=chunk) - Readers are cautioned not to place undue reliance on these statements, which speak only as of the date of the press release, and Crinetics does not plan to publicly update or revise them[12](index=12&type=chunk) Condensed Consolidated Financial Statement Data This section presents unaudited condensed consolidated financial statements, detailing statements of operations and balance sheet data [Statements of Operations Data](index=5&type=section&id=Statements%20of%20Operations%20Data) This section provides the unaudited condensed consolidated statements of operations for the three and six months ended June 30, 2025, and 2024, detailing revenues, operating expenses, loss from operations, other income, and net loss STATEMENTS OF OPERATIONS DATA (in thousands) | STATEMENTS OF OPERATIONS DATA: | Three months ended June 30, | | | Six months ended June 30, | | | :----------------------------- | :-------------------------- | :-- | :-- | :------------------------ | :-- | | | 2025 | | 2024 | 2025 | 2024 | | Revenues | $1,031 | | $399 | $1,392 | $1,039 | | Operating expenses: | | | | | | | Research and development | 80,301 | | 58,344 | 156,541 | 111,685 | | Selling, general and administrative | 49,842 | | 24,838 | 85,368 | 45,666 | | Total operating expenses | 130,143 | | 83,182 | 241,909 | 157,351 | | Loss from operations | (129,112) | | (82,783) | (240,517) | (156,312) | | Total other income, net | 13,475 | | 8,728 | 28,106 | 15,797 | | Loss before equity method investment | (115,637) | | (74,055) | (212,411) | (140,515) | | Loss on equity method investment | — | | — | — | (470) | | Net loss | $(115,637) | | $(74,055) | $(212,411) | $(140,985) | | Net loss per share - basic and diluted | $(1.23) | | $(0.94) | $(2.27) | $(1.86) | | Weighted-average shares - basic and diluted | 93,791 | | 79,008 | 93,448 | 75,690 | [Balance Sheet Data](index=5&type=section&id=Balance%20Sheet%20Data) This section presents the unaudited condensed consolidated balance sheet data as of June 30, 2025, and December 31, 2024, including cash, cash equivalents and investments, working capital, total assets, total liabilities, accumulated deficit, and total stockholders' equity BALANCE SHEET DATA (in thousands) | BALANCE SHEET DATA: | June 30, 2025 | December 31, 2024 | | :----------------------------- | :------------ | :---------------- | | Cash, cash equivalents and investments | $1,196,360 | $1,354,069 | | Working capital | $1,148,868 | $1,315,704 | | Total assets | $1,289,574 | $1,434,592 | | Total liabilities | $118,048 | $109,787 | | Accumulated deficit | $(1,164,521) | $(952,110) | | Total stockholders' equity | $1,171,526 | $1,324,805 |
Crinetics to Present New Long-Term Data Demonstrating Durable Control of Once-Daily, Oral PALSONIFY™ (Paltusotine) in Acromegaly at ENDO 2025
Globenewswire· 2025-07-13 21:45
Core Insights - Crinetics Pharmaceuticals announced new data on PALSONIFY (paltusotine) for acromegaly, highlighting its potential as a next-generation treatment option with a consistent safety profile and durable IGF-1 control [2][9] Group 1: Clinical Data and Results - The PATHFNDR-1 trial showed that 53 out of 58 participants (91%) entered the ongoing open-label extension after a 36-week randomized, placebo-controlled period, with interim analysis data available through Week 96 [3] - In the PATHFNDR-2 trial, 103 of 106 completers (97.2%) transitioned to the ongoing open-label extension after a 24-week randomized controlled period, with efficacy data from 88 patients through Week 84 [5] - Mean IGF-1 levels remained stable at 0.81 ± 0.21 times the upper limit of normal (ULN) at Week 96, demonstrating durable biochemical control [6][7] Group 2: Symptom Control and Patient Outcomes - Patients switching from injected somatostatin receptor ligands (SRLs) to PALSONIFY experienced a significant reduction in symptom exacerbations, from over 30% of days on SRLs to just 6.2% during stable PALSONIFY dosing (p < 0.0001) [8] - A pooled analysis of Acromegaly Symptom Diary (ASD) scores indicated that a greater proportion of patients treated with PALSONIFY reported less symptom burden compared to those on placebo [8] Group 3: Company Overview and Future Prospects - Crinetics Pharmaceuticals is focused on developing novel therapeutics for endocrine diseases, with PALSONIFY being the first investigational once-daily oral SST2 nonpeptide agonist in Phase 3 clinical development for acromegaly and carcinoid syndrome [9][10] - The company is also developing Atumelnant for congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome, with all drug candidates being orally delivered small molecules [10]
Crinetics Pharmaceuticals to Report Second Quarter 2025 Financial Results on August 7, 2025
Globenewswire· 2025-07-11 12:00
Group 1 - Crinetics Pharmaceuticals, Inc. will report its second quarter 2025 financial results on August 7, 2025, after market close [1] - A conference call will be held at 4:30 p.m. ET on the same day to discuss the financial results and provide a business update [1][2] - The conference call can be accessed via dial-in numbers or a live webcast, with a recommendation to connect 15 minutes prior to the start [2] Group 2 - Crinetics Pharmaceuticals is a clinical stage pharmaceutical company focused on developing novel therapeutics for endocrine diseases and related tumors [4] - The lead development candidate, PALSONIFY (paltusotine), is in clinical development for acromegaly and carcinoid syndrome associated with neuroendocrine tumors [4] - Other drug candidates include Atumelnant, which is in development for congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome, with all candidates being orally delivered small molecules [4]
Crinetics Pharmaceuticals (CRNX) 2025 Earnings Call Presentation
2025-07-11 08:45
Company Overview and Financial Status - Crinetics has a strong financial position with $1.3 billion in cash, cash equivalents, and investments[31] - The company anticipates its first commercial launch this year and holds IP rights into the 2040s[31] Pipeline Programs and Focus - Crinetics is developing paltusotine, with a PDUFA date in September 2025, for acromegaly[27] - The company is developing CRN12755, a TSHR antagonist, for Graves' Hyperthyroidism and Graves' Orbitopathy (TED), with plans for an IND submission[123] - Crinetics is advancing CRN10329, an SST3 agonist, for Autosomal Dominant Polycystic Kidney Disease (ADPKD), with IND-enabling studies ongoing[150] - The company is developing CRN09682, a nonpeptide drug conjugate (NDC), targeting SST2-expressing tumors, currently in Phase 1/2 study[254] Market and Patient Reach - Graves' Hyperthyroidism affects over 3 million individuals in the US, with a significant portion developing TED[75] - ADPKD affects approximately 145,000 diagnosed patients in the US, with 50% developing end-stage kidney disease[130, 131] - The addressable patient population for Graves' Orbitopathy (TED) is up to approximately 170,000 incident cases[120]
Crinetics Pharmaceuticals Announces July 2025 Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Globenewswire· 2025-07-10 20:28
Core Points - Crinetics Pharmaceuticals granted non-qualified stock option awards for 102,350 shares and restricted stock unit (RSU) awards for 77,875 shares to 46 new non-executive employees as part of the 2021 Employment Inducement Incentive Award Plan [1][2] - The stock options have an exercise price of $31.99 per share, equal to the closing price on July 10, 2025, and will vest over four years [2] - Crinetics Pharmaceuticals is focused on developing novel therapeutics for endocrine diseases and related tumors, with lead candidate paltusotine in clinical development for acromegaly and carcinoid syndrome [3] Summary by Category Stock Options and RSUs - The stock options and RSUs were granted as inducements for new employees under the 2021 Inducement Plan, in compliance with Nasdaq Listing Rule 5635(c)(4) [1][2] - Stock options will vest 25% after one year, with the remainder vesting in 36 equal monthly installments, contingent on continued employment [2] - RSUs will vest in equal annual installments over four years, also dependent on continued employment [2] Company Overview - Crinetics Pharmaceuticals is a clinical stage pharmaceutical company specializing in endocrine diseases and tumors [3] - The company’s lead candidate, paltusotine, is the first investigational oral selective somatostatin receptor type 2 nonpeptide agonist [3] - Other drug candidates in development include treatments for congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome, with a focus on orally delivered small molecules [3]
Crinetics to Showcase the Next Generation of Endocrinology Innovation at ENDO 2025 with Eight Presentations From its Deep Pipeline
Globenewswire· 2025-06-30 20:05
Core Insights - Crinetics Pharmaceuticals is set to present long-term efficacy and safety data for its investigational drug PALSONIFY (paltusotine) in acromegaly, demonstrating both biochemical and symptom control with a well-tolerated safety profile [1][2] - The company will also showcase Phase 2 trial results for atumelnant in congenital adrenal hyperplasia (CAH) and data from early-stage development programs in Graves' hyperthyroidism and orbitopathy at the Endocrine Society's Annual Meeting, ENDO 2025 [1][3] PALSONIFY Presentations - Four abstracts will report results from the PALSONIFY development program, including an oral presentation on long-term efficacy, safety, and symptom control in acromegaly patients switching from injectable somatostatin receptor ligands to once-daily oral PALSONIFY [2][4] - Three poster presentations will cover symptom stability in acromegaly, patient-reported outcomes from PATHFNDR-1 and PATHFNDR-2, and open-label extension data from PATHFNDR-2 [2] Atumelnant Presentations - Three abstracts will focus on atumelnant, including an oral presentation of Phase 2 trial results in CAH, highlighting reductions in adrenal volume and significant decreases in potent 11-oxygenated androgens [3][7] Early-Stage Pipeline - Crinetics will present new data from its early-stage pipeline, including findings related to CRN12755 for Graves' hyperthyroidism and orbitopathy [4][8] Company Overview - Crinetics Pharmaceuticals is a clinical-stage pharmaceutical company focused on developing novel therapeutics for endocrine diseases and related tumors, with PALSONIFY and atumelnant as its lead candidates [11]