Summary of Coya Therapeutics Update - February 17, 2026 Company Overview - **Company**: Coya Therapeutics (NasdaqCM: COYA) - **Focus**: Development of targeted therapies for ALS (Amyotrophic Lateral Sclerosis) Key Industry Insights - **ALS Treatment Landscape**: The approval of tofersen for SOD1 ALS has marked a significant development, indicating that targeted therapies can have a substantial impact on the disease's biology, potentially slowing, halting, or even reversing progression for a small subset of patients [3][4] - **Current Therapies**: Existing therapies show only modest benefits due to a lack of focus and understanding of the disease's biology. The industry is shifting towards more biologically informed clinical trials [5][6] Core Scientific Insights - **Neuroinflammation**: Neuroinflammation is identified as a critical factor in ALS pathology. The understanding of its role has evolved, with a focus on specific biological processes rather than broad observations [6][12] - **Regulatory T Cells (Tregs)**: Tregs are crucial for neuroprotection but are dysfunctional in ALS patients. Enhancing Treg function is a potential therapeutic target [13][14] Combination Therapy Rationale - **Combination of Low-Dose IL-2 and CTLA-4**: The rationale for this combination therapy is based on the need to enhance Treg function while suppressing inflammatory responses from activated macrophages. This dual approach aims to prevent Treg dysfunction and improve therapeutic outcomes [16][18][19] Clinical Trial Insights - **Initial Study Results**: A small study involving four ALS patients showed promising results, with some patients experiencing slowed progression and improved biomarkers related to inflammation and oxidative stress [24][25][26] - **ALSTARS Phase 2 Trial**: The upcoming trial aims to enroll 120 patients, with a design that includes a placebo group and two different dosing regimens for the combination therapy. The trial will measure clinical outcomes and biomarkers over six months [40][41][42] Safety and Tolerability - **Safety Profile**: Previous studies indicate that both IL-2 and CTLA-4 have favorable safety profiles, with no significant increase in infection rates observed. The low-dose IL-2 specifically activates Tregs without causing pro-inflammatory responses [56][59] Future Considerations - **Potential for FDA Approval**: If the trial meets its primary efficacy endpoint, Coya plans to submit an application for FDA approval. The strength of the data will be crucial for this process [65][66] - **Long-Term Outcomes**: There is optimism that slowing disease progression could correlate with improved survival rates, although ongoing monitoring of inflammation levels will be essential [62][64] Conclusion Coya Therapeutics is at the forefront of developing targeted therapies for ALS, with a strong focus on understanding the underlying biology of the disease. The upcoming ALSTARS trial represents a significant step towards validating the efficacy of combination therapies aimed at neuroinflammation and Treg dysfunction.

Core Insights - Coya Therapeutics, Inc. is developing COYA 303, a proprietary combination of LD-IL-2 and GLP-1RA, aimed at treating diseases like Alzheimer's Disease driven by chronic inflammation [1][2][3] - The initial results from an in vivo study indicate that COYA 303 significantly reduces neuroinflammation and enhances regulatory T cell (Treg) function, suggesting its potential in neurodegenerative conditions [2][3][6] - The company is currently conducting further experimental cohorts to evaluate modified treatment protocols and the timing of treatment initiation [4] Company Overview - Coya Therapeutics is a clinical-stage biotechnology company focused on enhancing Treg function to target systemic and neuroinflammation [5][7] - The company believes that Treg dysfunction is a key factor in various diseases, including neurodegenerative and autoimmune conditions [5][7] - Coya's therapeutic pipeline includes Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy [7] Study Findings - COYA 303 demonstrated significant systemic and central immunomodulatory effects, including enhanced Treg numbers and function, reduced activated myeloid cells, and attenuation of neuroinflammation in the cortex and hippocampus [6] - The findings from the first cohort of the study align with previous in vitro results, reinforcing the potential of COYA 303 in modulating inflammatory pathways associated with Alzheimer's Disease [1][3][6] - The CEO of Coya highlighted the growing interest in GLP-1 receptor agonists as potential therapies beyond metabolic diseases, positioning COYA 303 as a unique approach to address neuroinflammation [5]

Core Insights - Coya Therapeutics is positioned for a transformative year in 2025 with FDA clearance of its first IND and the initiation of a pivotal ALS trial [3][6] - The company is focused on developing Treg-modulating therapies to address ALS and other neurodegenerative diseases [4][6] Company Overview - Coya Therapeutics, Inc. is a clinical-stage biotechnology company headquartered in Houston, TX, specializing in treatments that target systemic inflammation and neuroinflammation through regulatory T cells (Tregs) [4][6] - The company’s pipeline includes Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy [5][6] Recent Developments - The FDA accepted the IND application for COYA 302 in ALS, allowing the start of a Phase 2 clinical trial [6] - Strategic partnerships, notably with Dr. Reddy's Laboratories, provide financial support and expertise in manufacturing and commercialization [6] Future Plans - Coya plans to expand its pipeline beyond ALS, with an IND filing for frontotemporal dementia expected in late 2025 [6] - Key upcoming milestones include the initiation of the ALS trial, data readouts for frontotemporal dementia, and new preclinical results across multiple programs [6]

Core Viewpoint - Coya Therapeutics, Inc. is actively engaging with investors through participation in two upcoming conferences, highlighting its focus on developing biologics for neurodegenerative disorders [1][2]. Company Overview - Coya Therapeutics, Inc. is a clinical-stage biotechnology company based in Houston, TX, specializing in treatments that enhance regulatory T cell (Treg) function to address systemic inflammation and neuroinflammation [4]. - The company’s investigational product pipeline includes Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy, aimed at restoring the anti-inflammatory and immunomodulatory functions of Tregs [5]. Upcoming Events - Coya will present at the H.C. Wainwright 27th Annual Global Investment Conference on September 10, 2025, at 10 am ET, with a presentation by CEO Arun Swaminathan [2]. - The company will also participate in the Lake Street Capital Markets 9th Annual Best Ideas Growth Conference on September 11, 2025, where management will be available for one-on-one meetings [2]. Webcast Information - Live and archived webcasts of the presentations will be accessible on the company's website under the Investor Relations section, with replays available for 90 days [3].