Financial Data and Key Metrics Changes - Alvotech reported total revenues of $420 million for the first nine months of 2025, representing a 24% year-on-year growth [20] - The company revised its full-year revenue guidance to a range of $570 million to $600 million, with adjusted EBITDA expected between $130 million and $150 million [24][25] - Adjusted EBITDA margin for the first nine months of 2025 was 16%, down from 26% in the previous year, primarily due to increased R&D investments [22] Business Line Data and Key Metrics Changes - Licensing revenues reached $81 million in Q3, supporting a strong gross margin of 69% [19] - The product margin for Q3 was reported at 27%, reflecting softness in the quarter [20] - Alvotech's revenue growth averaged 127% per year from 2021 to year-end 2024, with a projected compounded average growth rate of 94% from 2021 to the end of 2025 [10][11] Market Data and Key Metrics Changes - In the U.S., Alvotech holds the second-largest market share in the Humira biosimilar segment, with its products being the fastest-growing in this category [12] - In Europe, the biosimilar Yukindra has seen average quarter-on-quarter growth of 12% over the last four quarters and holds top positions in several major EU markets [12] - The company expects 50% of Stelara's European market to transition to biosimilars by year-end [13] Company Strategy and Development Direction - Alvotech aims to lead the biosimilar market, having invested approximately $2 billion in building a global biosimilar company with integrated R&D and manufacturing [4] - The company has expanded its R&D capabilities with a new operational base in Sweden and has a pipeline targeting over $185 billion of originated markets [5] - The strategic focus for the next 18 months includes executing multiple global launches and driving cost optimization to support margin expansion [25] Management's Comments on Operating Environment and Future Outlook - Management expressed disappointment over the Complete Response Letter (CRL) from the FDA but remains committed to resolving outstanding issues and expects approval for the BLA as early as the first half of 2026 [9] - The company anticipates strong growth in 2026, driven by committed orders for new launches and growth momentum in currently marketed products [35] - Management emphasized the importance of maintaining in-house R&D and manufacturing to ensure quality and compliance with regulatory standards [30] Other Important Information - Alvotech has five approved biosimilars and 12 other disclosed development programs, with over 15 cell lines completed for future development [5][17] - The company finalized the integration of Ivers-Lee, a Swiss-based assembly and packaging service provider, which will enhance its capacity for finished product assembly [19] Q&A Session Summary Question: Can you explain the observations related to the CRL? - Management clarified that the observations were not repeat issues and that significant improvements have been made since the inspection, with 93% of commitments to the FDA already completed [28][29] Question: How does the CRL impact customer conversations? - Management noted that there has been no reduction in interest from customers, and they continue to keep key clients updated on quality system improvements [33] Question: What is the expected revenue impact due to production slowdowns? - The CFO indicated that the revenue revision is due to production slowdowns and some licensing agreements shifting to 2026, which will impact Q4 EBITDA significantly [34][35] Question: What amendments have been made to production lines? - Management detailed improvements in manufacturing controls and documentation practices, ensuring that production is back to operating at full capacity for approved products [38][40] Question: How will regulatory changes affect earlier stage biosimilars? - Management stated that they anticipated regulatory changes and adjusted their R&D strategy accordingly, positioning themselves to take advantage of the new requirements [42]

Group 1 - Proactive specializes in providing fast, accessible, and actionable business and finance news content to a global investment audience [2][3] - The company focuses on medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - Proactive's news team operates from key finance and investing hubs, including London, New York, Toronto, Vancouver, Sydney, and Perth [2] Group 2 - The company employs technology to enhance workflows and improve content production [4] - Proactive utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

Core Viewpoint - A lawsuit has been filed against MoonLake Immunotherapeutics and its senior executives for potential violations of federal securities laws, following disappointing results from its Phase 3 VELA trials for sonelokimab [1][2][3]. Company Overview - MoonLake Immunotherapeutics is a clinical-stage biotechnology company focused on developing therapies for inflammatory diseases [3]. - The company conducted Phase 3 VELA trials for sonelokimab, an investigational therapeutic aimed at treating moderate to severe hidradenitis suppurativa [3]. Clinical Data and Claims - MoonLake claimed that its "strong clinical data" from the Phase 2 MIRA trial indicated higher clinical responses for patients and a competitive edge for sonelokimab [4]. - The company asserted that the Nanobody structure of SLK provided beneficial differences compared to traditional monoclonal antibody treatments [4]. Allegations and Stock Impact - Allegations suggest that the clinical data and Nanobody structure did not provide a superior clinical benefit over competitors, raising doubts about the drug's regulatory approval and commercial viability [5]. - Following the announcement of disappointing results from the VELA Phase 3 trials on September 28, 2025, MoonLake's stock plummeted nearly 90%, from $61.99 to $6.24 per share [6].

HAIFA, Israel, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Pluri Inc. (“Pluri” or the “Company”) (Nasdaq, TASE: PLUR), a leading biotechnology company leveraging its proprietary platform for cell-based solutions through a collaborative network of ventures, today announced that the Company and its subsidiaries have received multiple awards recognizing excellence in innovation, scientific achievement, and industry leadership. Pluri was named Overall BioAgriculture Company of the Year by the Biotech Breakthrough Awards ...

Core Insights - Humacyte, Inc. is set to present six studies on its acellular tissue engineered vessel (ATEV™) at the upcoming VEITHsymposium, a key event for vascular specialists [1][2][3] Presentation Details - The presentations will cover various applications of ATEV™, including its effectiveness in combat vascular trauma, torso arterial trauma, dialysis access, and long-term clinical use [2][3] - Notable presentations include outcomes from the War in Ukraine, case reports from clinical trials, and a review of published outcomes across multiple vascular indications [2][3] Company Overview - Humacyte is a biotechnology platform company focused on developing universally implantable bioengineered human tissues and advanced tissue constructs [3] - The FDA approved Humacyte's Biologics License Application for ATEV in December 2024, specifically for vascular trauma [3] - ATEV is currently in late-stage clinical trials for other vascular applications, including arteriovenous access for hemodialysis and peripheral artery disease [3] - The 6mm ATEV for AV access in hemodialysis was the first to receive the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation [3]

Core Insights - Century Therapeutics is advancing its iPSC-derived cell therapies targeting autoimmune diseases and cancer, with a focus on Type 1 diabetes (T1D) and B-cell-mediated diseases [2][5][6] Business Update - The company announced its lead iPSC-derived beta islet program for T1D, with plans to initiate IND-enabling studies by the end of 2025 and submit an IND as early as 2026 [2][5][6] - CNTY-308 is progressing through IND-enabling studies, aiming for clinical study initiation in 2026 [5][6] - CNTY-101 is continuing in a Phase 1/2 investigator-sponsored trial, with initial clinical data expected in December 2025 [6] Financial Results - As of September 30, 2025, cash, cash equivalents, and marketable securities totaled $132.7 million, down from $220.1 million at the end of 2024, with an estimated cash runway into Q4 2027 [6][10] - R&D expenses for Q3 2025 were $22.5 million, a decrease from $27.2 million in Q3 2024, primarily due to reduced personnel and manufacturing costs [6][10] - G&A expenses were $6.8 million for Q3 2025, down from $8.4 million in Q3 2024, attributed to a gain on lease modification [10] - The net loss for Q3 2025 was $34.4 million, compared to a net loss of $31.2 million for the same period in 2024 [10][13]

Core Insights - Adagene Inc. and Third Arc Bio, Inc. have entered into a licensing agreement for the use of Adagene's SAFEbody technology platform to develop masked CD3 T cell engagers targeting unique tumor-associated antigens [1][2] - Adagene will receive an upfront payment of $5 million and potential milestone payments totaling up to $840 million, along with royalties on end-user sales [1] - Adagene retains a no-cost option to develop and commercialize the candidate molecules in Greater China, Singapore, and South Korea [1] Company Overview: Adagene - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies using computational biology and artificial intelligence [3] - The company has established strategic collaborations leveraging its SAFEbody precision masking technology [3][4] - Adagene's lead clinical program, ADG126 (muzastotug), is currently in Phase 1b/2 and Phase 2 studies, targeting CTLA-4 in regulatory T cells within the tumor microenvironment [5] Technology Insights - The SAFEbody technology is designed to enhance safety and tolerability of antibody therapeutics by activating antibodies specifically in the tumor microenvironment, minimizing off-target toxicity [4] - Adagene's Dynamic Precision Library (DPL) platform includes NEObody™, SAFEbody, and POWERbody™ technologies, contributing to a differentiated pipeline of immunotherapy programs [4] Company Overview: Third Arc Bio - Third Arc Bio is a clinical-stage biotech company developing multifunctional antibodies aimed at precisely activating or inhibiting T cells [7] - The lead program, ARC101, is a bispecific T cell engager currently in Phase 1 trials for solid tumors expressing CLDN6 [8] - Third Arc Bio's platforms include the ARCStim Platform for solid tumors and the ARCTag Platform for precision immune regulation [7]

Allo-Evasion™ 5.0-engineered iPSC beta islets are designed to overcome immune rejection and provide durable glucose control without chronic immunosuppressionCompelling preclinical data demonstrate rapid reversal of diabetes and sustained normoglycemia, human C‑peptide production and mature GSIS, supported by scalable bioreactor-based manufacturingInvestigational New Drug (IND)-enabling studies on track to initiate by year-end 2025; IND submission planned as early as 2026 PHILADELPHIA, Nov. 13, 2025 (GLOBE N ...

Core Insights - Serina Therapeutics is advancing its lead investigational drug SER-252 for advanced Parkinson's disease, with a key milestone achieved in FDA alignment for a 505(b)(2) NDA pathway [2][6] - The company reported a net loss of $4.6 million for Q3 2025, compared to a net income of $1.4 million in Q3 2024, indicating a significant shift in financial performance [8][22] - Serina has secured up to $20 million in funding through a convertible note and warrant financing agreement, with the first tranche of $5 million already drawn [6] Financial Performance - Operating expenses for Q3 2025 were $6.4 million, up from $5.3 million in Q3 2024 [3] - Research and Development (R&D) expenses increased to $3.6 million in Q3 2025 from $2.4 million in Q3 2024, driven by higher outsourced research services and clinical activities [4] - General and Administrative expenses decreased slightly to $2.7 million in Q3 2025 from $2.9 million in Q3 2024, attributed to reduced compensation costs [5] - Other income for Q3 2025 was $1.8 million, a decrease from $6.7 million in Q3 2024, primarily due to changes in fair value of liability classified warrants [7] Liquidity and Capital Structure - As of September 30, 2025, cash and cash equivalents totaled $8.6 million, a significant increase from $3.7 million at the end of 2024 [9][20] - The company has entered into an At-the-Market (ATM) equity program allowing it to sell up to $13.3 million of common stock, with $2.8 million net proceeds from shares issued as of November 7, 2025 [6] Regulatory and Development Updates - The FDA has placed the IND for SER-252 on clinical hold pending additional information, but this does not relate to the active drug substance [6] - Serina is advancing SER-270 for tardive dyskinesia, with plans to complete formulation optimization and pre-IND activities in 2026 [6] - The SER-252 registrational study is designed to evaluate safety, tolerability, and pharmacokinetics, with a focus on motor fluctuations in Parkinson's disease [14]

Core Insights - Several small-cap healthcare and biotech companies experienced significant price increases in after-hours trading following earnings updates or upcoming financial disclosures [1] Company Summaries - MacroGenics, Inc. (MGNX) saw a 10.2% rise to $1.62 after hours, recovering from a 3.29% decline during the regular session. The company reported a third-quarter net income of $16.8 million, or $0.27 per share, down from $56.3 million, or $0.90 per share, year-over-year. Revenue fell to $72.8 million from $110.7 million [2] - SELLAS Life Sciences Group, Inc. (SLS) advanced 9.4% to $1.63 in after-hours trading. The company narrowed its quarterly net loss to $6.8 million, or $0.06 per share, compared to $7.1 million, or $0.10 per share, in the prior-year quarter. As of September 30, 2025, SELLAS reported cash and equivalents of approximately $44.3 million [3] - Standard BioTools Inc. (LAB) increased by 4.24% to $1.23 after hours, despite no official press releases or updates on Wednesday. The stock had closed slightly lower during the regular session [4] - KORU Medical Systems, Inc. (KRMD) gained 8.47% to $4.10 after hours, following a 1.34% increase earlier in the day. The company reported a narrower net loss of $0.8 million for the third quarter, compared to $1.6 million in the prior-year period. Revenue rose 27.2% to $10.4 million. KORU also raised its full-year revenue guidance to a range of $40.5 million - $41.0 million and reaffirmed its gross margin outlook of 61%-63% [5] - Hyperfine, Inc. (HYPR) climbed 8.18% to $1.19 after hours. No new announcements were made on Wednesday, but the company is scheduled to release its third-quarter results on Thursday, with analysts anticipating a loss of $0.10 per share and revenue of $3.52 million [6] - Wave Life Sciences Ltd. (WVE) added 5.68% to reach $7.35 in after-hours trading. The company reported a third-quarter net loss of $53.9 million, an improvement from $61.8 million in the prior-year quarter. Revenue for the period was $7.6 million, compared to a negative revenue figure of ($7.7) million last year [7]