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]

Table of Contents As filed with the Securities and Exchange Commission on January 16, 2024. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 KYVERNA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2836 83-1365441 (Primary Standard Industrial Classification Code Number) 5980 Horton St., STE 550 (I.R.S. E ...