Core Viewpoint - Coya Therapeutics, Inc. has announced its intention to conduct an underwritten public offering of common stock to raise funds for working capital and clinical development [1][2]. Company Overview - Coya Therapeutics is a clinical-stage biotechnology company based in Houston, TX, focused on developing biologics that enhance regulatory T cell (Treg) function to address neurodegenerative disorders [5]. - The company is developing proprietary treatments targeting systemic inflammation and neuroinflammation, with a focus on restoring the anti-inflammatory functions of Tregs [5][6]. Proposed Public Offering - The company plans to offer shares of its common stock and may grant underwriters a 30-day option to purchase an additional 15% of the shares at the public offering price [1]. - The net proceeds from the offering will be used for working capital and general corporate purposes, including funding its clinical development plan [2]. - The offering is subject to market conditions, and there is no assurance regarding its completion or the actual size and terms [1][2]. Clinical Development - Coya's investigational product candidate pipeline includes various therapeutic modalities aimed at enhancing Treg functions, such as Treg-enhancing biologics and autologous Treg cell therapy [6]. - The company is currently conducting the ALSTARS Trial, a Phase 2 study evaluating the efficacy and safety of its investigational product COYA 302 for the treatment of ALS [8].

Core Insights - Coya Therapeutics has completed patient enrollment for a proof-of-concept study on low-dose IL-2 and CTLA4-Ig combination treatment in patients with Frontotemporal Dementia (FTD) [1][2] - The study is progressing without safety issues, with completion anticipated in Q4 2025 [1][2] - The company aims to develop effective treatments for FTD, a neurodegenerative disease with high unmet medical need [3] Study Details - A total of 9 patients have been enrolled in the study, following positive interim results from 5 patients reported earlier [2] - The treatment regimen includes subcutaneous administration of CTLA4-Ig followed by a 5-day course of low-dose IL-2 every four weeks for a total of 22 weeks [1] - No serious adverse events or discontinuations due to safety issues have been reported, indicating a favorable safety profile [2] About Frontotemporal Dementia - FTD is characterized by altered behavior and language, with an estimated 30,000 Americans affected [4] - The average age of onset is 58, with an average survival time of 7.5 years [4] - FTD includes various subtypes, primarily behavioral-variant frontotemporal dementia and two language variants [4] Company Overview - Coya Therapeutics is a clinical-stage biotechnology company focused on developing treatments that enhance regulatory T cell (Treg) function to address systemic inflammation and neuroinflammation [5] - The company’s pipeline includes Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy [6]

Core Insights - Nektar Therapeutics announced positive results from the REZOLVE-AD Phase 2b study of rezpegaldesleukin, demonstrating significant efficacy in treating moderate-to-severe atopic dermatitis at the 2025 EADV Congress [1][2][9] Study Results - Rezpegaldesleukin achieved statistical significance on the primary endpoint of mean improvement in Eczema Area and Severity Index (EASI) at week 16 compared to placebo, with improvements of 61% for the high dose, 58% for the middle dose, and 53% for the low dose [2][3] - Key secondary endpoints also showed significant improvements, including EASI-75 (42% for high dose, 46% for middle dose, 34% for low dose) and vIGA-AD 0/1 response rates (20% for high dose, 26% for middle dose) [3][4] - Interim data for patients who crossed over from placebo to high dose rezpegaldesleukin indicated a mean EASI reduction of 68% at crossover week 16 and 75% at crossover week 24, with EASI-75 responses of 50% and 62% respectively [8] Patient-Reported Outcomes - Significant improvements were observed in patient-reported outcomes, including a 72% reduction in Daily Life Quality Index (DLQI) for the high dose group and a 67% reduction in Atopic Dermatitis Control Tool (ADCT) [5][6] - Pain Numeric Rating Scale (Pain NRS) showed a 45% reduction for the high dose group, indicating substantial relief from pain associated with atopic dermatitis [5] Safety Profile - The safety profile over the 16-week induction period showed that 60.3% of patients in pooled drug arms experienced any treatment-emergent adverse events (TEAEs), with serious adverse events occurring in 1.6% of patients [10][11] - The most common TEAEs included drug hypersensitivity and pyrexia, with all events resolving [10][11] Study Design and Enrollment - The global Phase 2b REZOLVE-AD study randomized 393 patients across approximately 110 sites, with a significant portion (68%) enrolled in Europe [12][18] - Patients were stratified based on baseline disease severity, ensuring a robust assessment of treatment efficacy [12] Future Outlook - Nektar Therapeutics is preparing to report results for rezpegaldesleukin in patients with alopecia areata in December 2025, following the promising data from the atopic dermatitis study [9][14]

Nektar Therapeutics FY Conference Summary Company Overview - Nektar Therapeutics is a global biopharmaceutical company focused on developing novel therapies that selectively moderate the immune system to treat autoimmune disorders, leveraging expertise in polymer chemistry [2][4] Core Points and Arguments Pipeline and Lead Program - The lead program, Respag Aldis Leukin, targets the IL-2 receptor pathway and acts as an agonist, expanding regulatory T cells (Tregs) in patients [5] - A preclinical program focuses on TNF receptor two agonism, targeting inducible regulatory T cells for tissue inflammation and regeneration, with clinical activity expected to begin in 2026 [6] Clinical Study Results - A phase one study with 40 patients showed Respag had a profound effect on controlling disease activity in moderate to severe atopic dermatitis [7] - A subsequent phase two study with 400 patients demonstrated a rapid onset of efficacy, with a dose-dependent reduction in the EASI score, achieving over 30% placebo-adjusted delta [8] - The high dose of 24 micrograms per kilogram administered subcutaneously twice a month met all secondary endpoints, including significant improvements in itch control [9][10] Competitive Landscape - Respag is compared to existing biologics like Dupixent and Adbri, which target IL-4 and IL-13 pathways. Respag's unique mechanism as an agonist may provide broader efficacy [11][12] - The phase three results of competing drugs showed less efficacy than their phase two results, raising questions about their competitive positioning [13][14] Future Expectations - The ongoing crossover cohort study will provide insights into the long-term efficacy of Respag beyond the initial 16-week induction period [15][16] - An end-of-phase two meeting with the FDA is planned to discuss the design for a potential registration trial, focusing on biologic-naive and experienced patients [21][23] Market Potential - Respag's mechanism allows for potential use across various treatment lines, with a remitted effect observed in phase one studies, indicating long-lasting disease control [29][30] - The alopecia areata market is currently dominated by JAK inhibitors, but Respag's unique profile could position it as a transformative treatment option [38][39] Upcoming Catalysts - Key upcoming data updates include: - Atopic dermatitis induction data at EADV [40] - Top-line results from the alopecia areata study in December [40] - Maintenance results from the atopic dermatitis study in Q1 next year [40] - The company has a year-end cash position of $185 million [41] Additional Important Information - The rationale for targeting alopecia includes the role of Tregs in maintaining immune privilege in hair follicles, which could lead to effective treatment outcomes [35][36] - The primary endpoint for the alopecia study is the percent change in SALT score, with additional registrational endpoints for FDA and European approval [37]