Celldex Announces Initial Positive Results from Phase 1 Trial of CDX-622 Demonstrating Favorable Safety and PK Profile and Sustained Mast Cell Inhibition
Globenewswire· 2025-10-30 20:01
Core Insights - Celldex announced positive data from the Phase 1 study of CDX-622, a bispecific antibody targeting inflammation and fibrosis pathways [1][2] - The study demonstrated good tolerability, a favorable pharmacokinetic profile, and significant reductions in serum tryptase levels, indicating effective mast cell inhibition [1][6] - The company plans to advance the study to the next phase, testing multiple ascending doses and initiating a Phase 1b study in asthma patients [2][4] Study Design and Results - The Phase 1 trial is a randomized, double-blind, placebo-controlled, dose escalation study assessing safety, pharmacokinetics, pharmacodynamics, and immunogenicity of CDX-622 [4][7] - Part 1 enrolled 32 participants across 4 cohorts, receiving single ascending intravenous doses of CDX-622 (0.3, 1.0, 3.0, and 9.0 mg/kg) over a 12-week observation period [4][6] - Data from Part 1 were presented, and enrollment for Part 2 is ongoing, with results from Parts 2 and 3 expected in Q3 2026 [4][6] Mechanism and Therapeutic Potential - CDX-622 targets two validated pathways: neutralizing TSLP and depleting mast cells via SCF starvation, potentially offering enhanced therapeutic benefits for inflammatory and fibrotic disorders [5][6] - The antibody showed a serum half-life of approximately 18 days at 9 mg/kg, with no evidence of immunogenicity or dose-limiting toxicities observed [6][2] - A single dose led to a rapid and sustained decrease of about 50% in circulating tryptase, consistent with systemic mast cell inhibition [6]
Monolithic Power Systems Provides Earnings Commentary for the Quarter Ended September 30, 2025
Globenewswire· 2025-10-30 20:01
Core Insights - MPS reported record quarterly revenue of $737.2 million for Q3 2025, reflecting a 10.9% increase from Q2 2025 and an 18.9% increase year-over-year from Q3 2024 [3][8][13] - The company's diversified market strategy contributed to revenue growth across all end markets, showcasing resilience in its product portfolio and customer focus [8][12] Financial Performance - Revenue for Q3 2025 was $737,176,000, with a gross margin of 55.1%, flat compared to Q2 2025 [3][20] - Operating expenses increased to $211,045,000, up 4.9% quarter-over-quarter and 17.6% year-over-year [3][23] - Net income for Q3 2025 was $178,274,000, representing a 33.3% increase from Q2 2025 and a 23.4% increase year-over-year [3][25] Non-GAAP Metrics - Non-GAAP net income for Q3 2025 was $227,114,000, with a diluted EPS of $4.73, up 12.4% from Q2 2025 [5][25] - Non-GAAP gross margin was reported at 55.5%, consistent with Q2 2025 [22][36] Revenue by End Market - Enterprise Data revenue reached $191.5 million, up 33% from Q2 2025, driven by sales of power management solutions for AI applications [14] - Automotive revenue was $151.5 million, a 4.4% increase from Q2 2025, with a year-over-year growth of 36.1% [18] - Storage and Computing revenue decreased by 4.5% from Q2 2025 to $186.6 million, but showed a year-over-year increase of 29.6% [19] Cash Flow and Balance Sheet - Cash, cash equivalents, and short-term investments totaled $1,269.5 million at the end of Q3 2025, up from $1,146.1 million in Q2 2025 [27][31] - Operating cash flow for Q3 2025 was $239.3 million, slightly higher than $237.6 million in Q2 2025 [27][31] Business Outlook - For Q4 2025, MPS forecasts revenue in the range of $730 million to $750 million, with a GAAP gross margin between 54.9% and 55.5% [33][48]
Alignment Healthcare Reports Third Quarter 2025 Results, Surpasses High-End of Guidance Across All Key Metrics
Globenewswire· 2025-10-30 20:01
Core Insights - Alignment Healthcare, Inc. reported strong financial results for Q3 2025, surpassing guidance across all key metrics for the third consecutive quarter [2][6][7] - The company achieved a revenue of $993.7 million, representing a 43.5% increase year-over-year, and maintained 100% of its members in plans rated 4 stars or higher for the second consecutive year [6][7] Financial Highlights - Health plan membership reached approximately 229,600, up 25.9% year-over-year [7] - Adjusted gross profit for Q3 2025 was $127.5 million, with an income from operations of $7.7 million [7] - Adjusted EBITDA was reported at $32.4 million, with a net income of $3.7 million [7][8] Outlook - For Q4 and the full fiscal year 2025, the company projects health plan membership between 232,500 and 234,500, revenue between $995 million and $1,010 million, and adjusted EBITDA ranging from $(9) million to $(1) million [4] - The full-year revenue outlook is expected to be between $3.931 billion and $3.946 billion [4] Operational Metrics - The medical benefits ratio based on adjusted gross profit was 87.2% [7] - The company reported total medical expenses of $868.0 million for Q3 2025, compared to $613.4 million in Q3 2024 [17] Cash Flow and Balance Sheet - Cash and cash equivalents at the end of Q3 2025 were $618.1 million, up from $432.9 million at the end of 2024 [14][20] - Total assets increased to $1.102 billion from $782.1 million at the end of 2024 [14]
Prime Medicine to Host Virtual KOL Event to Showcase Wilson’s Disease Strategy
Globenewswire· 2025-10-30 20:01
Core Insights - Prime Medicine, Inc. is set to host a virtual event on November 12, 2025, to discuss its liver disease franchise, particularly focusing on Wilson's Disease [1][2] - The company plans to file an investigational new drug (IND) and/or clinical trial application (CTA) for PM577, targeting H1069Q-driven Wilson's Disease, in the first half of 2026, with initial clinical data expected in 2027 [1][9] Company Overview - Prime Medicine is a biotechnology company focused on developing one-time curative genetic therapies using its proprietary Prime Editing platform, which allows precise and efficient gene editing [4][5] - The company aims to address a range of genetic mutations across various tissues and diseases, potentially unlocking thousands of indications [4][5] Strategic Focus - Prime Medicine is concentrating on high-value programs in liver, lung, and immunology and oncology, with a clear clinical development path for each [5] - The company intends to leverage the modularity of its Prime Editing platform to accelerate the development of therapies for Wilson's Disease and other genetic conditions [8][9] Market Opportunity - There is currently no curative therapy for Wilson's Disease, and existing treatments face challenges related to compliance, cost, and tolerability [8] - Prime Editing has the potential to provide a durable cure for Wilson's Disease by precisely addressing its genetic causes [8][9]
Alpine Banks of Colorado announces financial results for third quarter 2025
Globenewswire· 2025-10-30 20:00
GLENWOOD SPRINGS, Colo., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Alpine Banks of Colorado (OTCQX: ALPIB) (“Alpine” or the “Company”), the holding company for Alpine Bank (the “Bank”), today announced results (unaudited) for the third quarter ended September 30, 2025. The Company reported net income of $18.5 million, or $1.16 per basic Class A common share and basic Class B common share, for third quarter 2025. Highlights in third quarter 2025 include: Basic earnings per Class A and Class B common shares increased ...
BayFirst Financial Corp. Reports Third Quarter 2025 Results, Announces Restructuring Plan Including Exit From SBA 7(a) Lending
Globenewswire· 2025-10-30 20:00
Core Insights - BayFirst Financial Corp. reported a significant net loss of $18.9 million, or $4.66 per share, for Q3 2025, compared to a net loss of $1.2 million in Q2 2025, primarily due to higher provision expenses and one-time charges related to restructuring [1][8][29] Financial Performance - The net interest margin decreased to 3.61% in Q3 2025 from 4.06% in Q2 2025, but increased from 3.34% in Q3 2024 [7][10] - Net interest income from continuing operations was $11.3 million in Q3 2025, down from $12.3 million in Q2 2025, but up from $9.4 million in Q3 2024 [10][11] - Noninterest income was negative $1.0 million in Q3 2025, a significant decrease from $10.8 million in Q2 2025 and $12.3 million in Q3 2024 [14][17] Strategic Initiatives - The company is undergoing a strategic transformation, including exiting the SBA 7(a) lending business and selling a portion of its loan portfolio to Banesco USA for 97% of the retained loans' balances, resulting in a net loss of $5.1 million [3][29] - Management is focused on derisking the balance sheet and enhancing long-term growth and shareholder value, with plans to close the SBA loan sale in Q4 2025 [3][4] Asset Quality - The provision for credit losses in Q3 2025 was $10.9 million, up from $7.3 million in Q2 2025 and $3.1 million in Q3 2024 [24] - The allowance for credit losses on loans was 2.61% of total loans held for investment as of September 30, 2025, compared to 1.65% in Q2 2025 and 1.48% in Q3 2024 [25] Balance Sheet Highlights - Total assets increased by $2.1 million, or 0.2%, to $1.35 billion in Q3 2025, driven by an increase in cash and cash equivalents [20] - Loans held for investment decreased by $127.1 million, or 11.3%, during Q3 2025, primarily due to the transfer of loans to held for sale [21] - Total deposits increased by $7.7 million, or 0.7%, during Q3 2025, totaling $1.17 billion [22] Capital and Liquidity - The Tier 1 leverage ratio was 6.64% as of September 30, 2025, down from 8.11% in Q2 2025 [27] - The bank's liquidity position remains strong, with an on-balance sheet liquidity ratio of 11.31% as of September 30, 2025 [28]
¬Nephros Schedules Third Quarter 2025 Financial Results Conference Call
Globenewswire· 2025-10-30 20:00
SOUTH ORANGE, N.J., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Nephros, Inc. (Nasdaq: NEPH), a leading water technology company providing filtration solutions to the medical and commercial markets, today announced that it will file its third-quarter financial results on Thursday, November 6, 2025 after market close and will host a conference call that same day at 4:30pm ET. Participants may dial into the call as follows:Domestic access: 1 (844) 808-7106International access: 1 (412) 317-5285 Upon joining, please ask ...
TME Pharma publishes its semi annual results and half-year report
Globenewswire· 2025-10-30 20:00
TME Pharma publishes its semi annual results and half-year report Berlin, Germany, October 30, 2025, 21.00am CET – TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company specializing in the development of novel therapies for cancer and eye diseases, publishes today its semi annual results and half-year report. The first half of the year was marked by TME Pharma's reorganization to a lower-cost outsourced staffing model. The results of this can be seen from H2 onwards, namely ...
Aspocomp has carried out a Directed Share Issue and agreed on new long-term financing arrangement to secure growth
Globenewswire· 2025-10-30 19:50
Aspocomp Group Plc., Inside information, Stock Exchange Release, October 30, 2025, at 9.50 p.m. (UCT+2) Aspocomp has carried out a Directed Share Issue and agreed on new long-term financing arrangement to secure growth Aspocomp Group Plc’s Board of Directors has today on October 30, 2025, carried out a directed share issue (the "Directed Share Issue"), to certain current shareholders of the Company and to a limited number of Finnish and qualified investors in deviation of the pre-emptive subscription rights ...
Truxton Welcomes Jeffrey Laborde to Board of Directors
Globenewswire· 2025-10-30 19:28
NASHVILLE, Tenn., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Truxton Trust Company is pleased to announce that Jeffrey M. Laborde has joined its Board of Directors. Mr. Laborde brings more than three decades of experience in corporate finance, strategic advisory, and public accounting, with a distinguished career leading global technology businesses and advising boards at all stages of the corporate lifecycle. Mr. Laborde currently serves as Chief Financial Officer of JAGGAER LLC, a leading business spend and procur ...