COYA

HOUSTON, May 12, 2026--(BUSINESS WIRE)--Coya Therapeutics, Inc. (NASDAQ: COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company developing biologics intended to enhance T-cell (Treg) function in patients with neurodegenerative disorders, announces its financial results for the quarter ended March 31, 2026 and provides a corporate update. "We are off to a strong start in 2026, building on the clinical and scientific progress achieved last year," said Arun Swaminathan, Ph.D., Chief Executive Officer of Coya. "The ALSTARS trial is now in full recruitment mode, and we maintain our guidance for a 1Q 2027 topline readout. With a solid foundation and balance sheet in place we are well positioned to deliver on our priorities for 2026." Recent Corporate Highlights FDA granted Fast Track Designation to COYA 302 for the treatment of ALS on May 11, 2026. Fast Track Designation is intended to facilitate the development and expedite the review of drugs that treat serious conditions and address unmet medical needs. Announced U.S. FDA acceptance of Investigation New Drug (IND) Application for COYA 302 for the treatment of frontotemporal dementia (FTD). Reported results of the investigator-initiated study of low-dose IL-2 and CTLA4-Ig combination treatment demonstrating Treg enhancement and cognitive stability in FTD patients. Announced $11.1 million private placement, led by Dr. Reddy’s Laboratories, Inc. ($10 million) and Greenlight Capital ($1.1 million), an existing institutional stockholder of the Company. Announced publication in Brain Communications demonstrating regulatory T-cell dysfunction and system inflammation in frontotemporal dementia, supporting mechanistic rationale for the use of COYA 302 as a therapy in patients with frontotemporal dementia. Announced publication in Annals of Clinical and Translational Neurology demonstrating correlation between longitudinal biomarker data and clinical outcomes supporting the mechanistic rationale for COYA 302 in patients with ALS. The ALSTARS protocol was amended to remove the prior exclusion criteria for patients receiving antihypertensive medications and for those with controlled autoimmune diseases. The amended protocol was cleared through both FDA and Health Canada and is expected to allow for a broader patient population, which we believe will increase the enrollment rate. Upcoming Expected Catalysts...

HOUSTON, March 16, 2026--(BUSINESS WIRE)--Coya Therapeutics, Inc. (NASDAQ: COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company developing biologics intended to enhance T-cell (Treg) function in patients with neurodegenerative disorders, provides a corporate update and announces its financial results for the year ended December 31, 2025. Corporate Highlights FY 2025 to Date COYA 302 Successfully launched the ALSTARS Phase 2 trial evaluating COYA 302 for the treatment of ALS and now actively enrolling and dosing patients across ~25 clinical sites in the U.S. and Canada. Clinical Trial Application (CTA) acceptance from Health Canada to proceed with the COYA 302 ALSTARS Phase 2 trial in Canada. Announced COYA 302 ALS trial acceptance by NEALS as a NEALS-affiliated trial. Announced U.S. FDA acceptance of Investigation New Drug (IND) Application for COYA 302 for the treatment of frontotemporal dementia (FTD). Reported results of the investigator-initiated study of low-dose IL-2 and CTLA4-Ig combination treatment demonstrating Treg enhancement and cognitive stability in FTD patients. COYA 303 Reported interim findings of COYA 303 showing potent systemic and brain anti-inflammatory activity and enhanced Treg cell function in an in vivo lipopolysaccharide (LPS) preclinical mouse model of systemic and neurologic inflammation. Scientific validation Published results in Frontiers in Immunology linking inflammation and oxidative stress to the progression of Parkinson’s disease. Published results in the Journal NeuroImmune Pharmacology and Therapeutics demonstrating COYA 303’s synergistic enhancement of regulatory T cell function and protection against Treg apoptosis (cell death). Announced the issuance of a U.S. patent relevant to its investigational ready-to-use (RTU) liquid formulation of IL-2. Through an existing agreement, Coya has the exclusive in vivo rights to this patent and other related intellectual property spanning multiple indications both as monotherapy and combination therapies. Financial Highlights FY 2025 to Date Announced $23.0 million upsized public offering of common stock; extends cash runaway into 2H 2027. Announced $11.1 million private placement, led by Dr. Reddy’s Laboratories, Inc. ($10 million) and Greenlight Capital ($1.1 million), an existing institutional stockholder of the Company. Upcoming Expected Catalysts for 2026 1H...

Robust target engagement was observed, with statistically significant increases in regulatory T-cell (Treg) suppressive function and Treg numbers beginning as early as two weeks post-dosing and sustained through the 22-week treatment period. Cognitive measures remained stable, with no evidence of cognitive decline or meaningful change from baseline in either the Montreal Cognitive Assessment (MoCA) or the CDR-FTLD scores over 22 weeks. HOUSTON, January 08, 2026--(BUSINESS WIRE)--Coya Therapeutics, Inc. (NASDAQ: COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company focused on developing biologics that enhance regulatory T cell (Treg) function in patients with neurodegenerative disorders, today announced positive results of an investigator-initiated proof of concept open-label study with low-dose IL-2 and CTLA4-Ig combination treatment in 9 patients with Frontotemporal Dementia (FTD) over a 6 month period. The study was led by Dr. Alireza Faridar and Dr. Stanley Appel at the Houston Methodist Neurological Institute (Houston, TX) with funding from The Peggy and Gary Edwards Endowment Fund. Study patients received subcutaneously administered CTLA4-Ig, along with a 5-day course of low-dose IL-2 every four weeks, for a total of 22 weeks of dosing and follow-up. The study enrolled 9 patients, and data demonstrated enhanced Treg numbers and function and cognitive function stability as measured by CDR-FTLD and Montreal Cognitive Assessment (MOCA). Dr. Arun Swaminathan, Coya’s Chief Executive Officer followed: "We believe these results suggest the potential for COYA 302 as a therapeutic option for patients with FTD. We look forward to advancing COYA 302 in a well-controlled phase 2 clinical trial in patients with FTD." Dr. Fred Grossman, Coya’s Chief Medical Officer said: "We believe this study continues to add evidence that restoring Treg numbers and function has the potential to translate to clinically meaningful effects across multiple neurodegenerative diseases." Study Results The data presentation can be found in this LINK Safety and feasibility Nine individuals clinically diagnosed with FTD were enrolled into this study. The primary endpoints were the incidence and severity of adverse events. The most common adverse event was erythema at the injection site (33.3% of individuals), which was mild and recovered spontaneously. No serious adverse ev...

HOUSTON, November 12, 2025--(BUSINESS WIRE)--Coya Therapeutics, Inc. (NASDAQ: COYA) (Coya or the Company), a clinical-stage biotechnology company focused on developing biologics that enhance regulatory T cell (Treg) function in patients with neurodegenerative disorders, provides a corporate update and announces its financial results for the quarter ended September 30, 2025. Recent Corporate Highlights Published a study in Frontiers in Immunology linking inflammation and oxidative stress to the progression of Parkinson’s disease. Announced FDA acceptance of Investigational New Drug (IND) application for COYA 302 for the treatment of Amyotrophic Lateral Sclerosis (ALS). Received $4.2 million from strategic partner Dr. Reddy’s Laboratories for the achievement of IND approval milestone. Launched the ALSTARS Trial, a Phase 2 clinical study to assess the efficacy and safety of COYA 302 in ALS. Announced COYA 302 ALS Trial accepted by NEALS as a NEALS-affiliated trial. Reported results from the first cohort of a preclinical in-vivo animal study demonstrating COYA 303 (LD IL-2 and GLP-1RA) showed promising Central Nervous System (CNS) anti-inflammatory effects and systemic regulatory T cell (Treg) enhancing effects. Completed patient enrollment in an investigator-initiated, open-label study with low-dose IL-2 and CTLA4-Ig combination treatment in patients with mild to moderate Frontotemporal Dementia (FTD). Announced closing of $23.0 million upsized public offering of common stock; financing extends cash runway into 2H 2027. Upcoming Expected Catalysts First patient enrolled in COYA 302 ALSTARS Trial. First patient dosed in COYA 302 ALSTARS Trial. Upon first patient dosing of COYA 302 in ALS, expect to receive $4.2 million milestone payment from strategic partner, Dr. Reddy’s Laboratories (DRL). Presentation and publication of the comprehensive in-vivo animal data set of COYA 303 (LD IL-2 + CTLA-4 Ig) and impact on systemic and brain inflammation. ALS Biomarker data. Publication of longitudinal data on Neurofilament Light Chain (NfL) and oxidative stress markers in patients with ALS. Report additional single cell proteomics data from the completed investigator-initiated, 21-week, double-blind, placebo-controlled, exploratory Phase 2 study of low-dose interleukin-2 (LD IL-2) in patients with Alzheimer’s disease (AD). Top-line clinical data release for an investigator...

Explore Coya Therapeutics's Fair Values from the Community and select yours Net loss: US$6.09m (loss widened by 111% from 2Q 2024). US$0.36 loss per share (further deteriorated from US$0.19 loss in 2Q 2024). This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue missed analyst estimates by 76%. Earnings per share (EPS) exceeded analyst estimates by 14%. Looking ahead, revenue is forecast to grow 53% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's shares are down 3.1% from a week ago. We don't want to rain on the parade too much, but we did also find 3 warning signs for Coya Therapeutics (2 are significant!) that you need to be mindful of. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

HOUSTON, Aug. 12, 2025 /PRNewswire/ -- Coya Therapeutics, Inc. (NASDAQ: COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company focused on developing biologics that enhance regulatory T cell (Treg) function in patients with neurodegenerative disorders, provides a corporate update and announces its financial results for the quarter ended June 30, 2025. Recent Corporate Highlights Submitted to FDA on June 30, 2025, additional nonclinical data to support the start of the COYA 302 Phase 2 trial in patients with ALS Published results of scientific research linking inflammation and oxidative stress to the progression of Parkinson's Disease (PD). Study demonstrated correlation between peripheral pro-inflammatory mechanisms, particularly monocytes and oxidative stress, in the progression and severity PD. It was published in the scientific journal Frontiers of Immunology Announced U.S. patent (US 12,312,389 B2) for a stable ready-to-use liquid IL-2 formulation; Coya holds exclusive in-vivo rights across multiple indications Upcoming Expected Catalysts for 2025 Decision from the US FDA on the IND for COYA 302 in ALS, expected by or before August 29, 2025 Upon IND acceptance and first patient dosing of COYA 302 in ALS, Coya will receive milestone payments of $8.4 million from strategic partner, Dr. Reddy's Laboratories (DRL) ALS Biomarker data. Publication of longitudinal data on Neurofilament Light Chain (NfL) and oxidative stress markers in tracking progression and survival in patients with ALS Report new proteomics data from the completed investigator-initiated, 21-week, double-blind, placebo-controlled, exploratory Phase 2 study of low-dose interleukin-2 (LD IL-2) in patients with Alzheimer's disease (AD) Top-line clinical data release for an investigator-initiated trial combining LD IL-2 + CTLA4-Ig in patients with Frontotemporal Dementia (FTD) Top-line data for COYA 303 in an in-vivo inflammatory animal model Filing of IND for the COYA-302 Phase 2 trial in patients with FTD* (*Clinical trial will be initiated after FDA IND approval for FTD) Coya's Chief Executive Officer Arun Swaminathan, Ph.D. commented, "As we look ahead, we are focused on several key catalysts, including a decision from the FDA on our IND application for COYA 302 in ALS, anticipated by the end of August. We are encouraged by the growing body of data supporting our regulatory T...

Revenue: US$257.9k (up 103% from 1Q 2024). Net loss: US$7.31m (loss widened by 45% from 1Q 2024). US$0.44 loss per share (further deteriorated from US$0.35 loss in 1Q 2024). Our free stock report includes 3 warning signs investors should be aware of before investing in Coya Therapeutics. Read for free now. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue missed analyst estimates by 90%. Earnings per share (EPS) also missed analyst estimates by 126%. Looking ahead, revenue is forecast to grow 41% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's shares are down 3.4% from a week ago. It's still necessary to consider the ever-present spectre of investment risk. We've identified 3 warning signs with Coya Therapeutics, and understanding these should be part of your investment process. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com.This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

HOUSTON, May 13, 2025--(BUSINESS WIRE)--Coya Therapeutics, Inc. (Nasdaq: COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, provides a corporate update and announces its financial results for the quarter ended March 31, 2025. Recent Corporate Highlights Announced positive interim results of an investigator-initiated proof of concept open-label study with low-dose (LD) IL-2 and CTLA4-Ig combination treatment in patients with Frontotemporal Dementia (FTD) Published results of a study designed to evaluate the effects of COYA 303 (LD IL-2 and GLP-1RA), Coya’s investigational biologic combination to suppress pro-inflammatory myeloid cells, enhance Treg suppressive function, and modulate T cell proliferation, in an in vitro system of human immune cells obtained from healthy donors. The study was published in NeuroImmune Pharmacology and Therapeutics Reported progress from an academic supported first-in-class Treg-derived Exosome program of its investigational regulatory T cell-derived exosome (Treg exosomes) platform intended for the treatment of systemic and neurodegenerative diseases driven by chronic inflammation Announced significant improvements of inflammatory blood markers from an investigator-initiated, 21-week, double-blind, placebo-controlled, exploratory Phase 2 study of LD IL-2 in patients with Alzheimer’s disease (AD) Announced expansion of pipeline - COYA 303 and COYA 301 - in combination with GLP-1 Receptor Agonist for treatment of inflammatory diseases and filing of new intellectual property portfolio for the combination. Upcoming Expected Catalysts for 2025 Submission of additional nonclinical data to support the start of the COYA 302 Phase 2 trial in patients with ALS expected by the end of the Q2 Upon IND acceptance and first patient dosing of COYA 302 in ALS, expect to be eligible to receive milestone payments of $8.4 million from strategic partner, Dr. Reddy’s Laboratories (DRL) Publication of data documenting role of inflammation in Parkinson’s Disease ALS Biomarker data. Publication of longitudinal data on Neurofilament Light Chain (NfL) and oxidative stress markers in patients with ALS. Report additional single cell proteomics data from the completed investigator-initiated, 21-week, double-blind, placebo-controlled, exploratory Phase 2 study of...

Results from the first patient cohort (N=5) of an open-label proof of concept academic study with low-dose IL-2 and CTLA4-Ig demonstrated a rapid and durable statistically significant increase in the number and suppressive function of Tregs compared to baseline values. Clinically, patients with Frontotemporal Dementia (FTD) demonstrated minimal to no cognitive decline throughout the study period. Treatment was well tolerated, no serious adverse events were reported, and all 5 patients completed the study. HOUSTON, April 24, 2025--(BUSINESS WIRE)--Coya Therapeutics, Inc. (NASDAQ: COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function announced positive interim results of an investigator-initiated proof of concept open-label study with low-dose IL-2 and CTLA4-Ig combination treatment in patients with Frontotemporal Dementia (FTD). The study is led by Dr. Alireza Faridar and Dr. Stanley Appel at the Houston Methodist Neurological Institute (Houston, TX) with funding from The Peggy and Gary Edwards Endowment Fund. Study patients received subcutaneously administered CTLA4-Ig, followed by a 5-day course of low-dose IL-2 every four weeks, for a total of 22 weeks of dosing and follow-up. The study aims to enroll up to 10 patients, and these interim results include data from the first 5 patients with mild to moderate FTD who have completed the full course of treatment. Dr. Arun Swaminathan, Coya’s Chief Executive Officer followed: "The results thus far are consistent with previously published encouraging data from an open-label investigator-initiated study of patients with ALS treated with low-dose IL-2/CTLA4-Ig. This interim data in FTD provides us further confidence of our approach to target and enhance Treg biology to address devastating neurodegenerative diseases including ALS and FTD." Previous biomarker data presented by the Company demonstrated that FTD patients exhibit a compromised immunosuppressive function of regulatory T cells (Tregs), along with increased peripheral levels of inflammatory cytokines and chemokines, dysregulation of monocytes, and systemic activation of the inflammatory cascade, supporting the critical role of the immune system in the pathophysiology of FTD. One previous study showed that a cohort of 68 patients with FTD worsened by an average of 3....

HOUSTON, March 18, 2025--(BUSINESS WIRE)--Coya Therapeutics, Inc. (Nasdaq: COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, provides a corporate update and announces its financial results for the year ended December 31, 2024. Corporate Highlights FY2024 to Date Announced significant improvements of inflammatory blood markers from an investigator-initiated, 21-week, double-blind, placebo-controlled, exploratory Phase 2 study of low-dose interleukin-2 (LD IL-2) in patients with Alzheimer’s disease (AD) Announced that five of eight patients have been enrolled in the investigator-initiated academic study of LD IL-2 + CTLA4-Ig combination in patients with Frontotemporal Dementia (FTD) Announced positive results from an investigator initiated double-blind study of low-dose interleukin-2 (LD IL-2) in patients with mild to moderate Alzheimer’s Disease (AD) at the Clinical Trials on Alzheimer’s Disease Conference (CTAD24) in Madrid. The study was titled, "A Phase II Clinical Trial of Interleukin-2 (IL-2) in Patients with Mild to Moderate Alzheimer's Disease" Aligned with FDA on the non-clinical data needed to support the planned randomized, double-blind, placebo-controlled, Phase 2b trial of COYA-302 in patients with Amyotrophic Lateral Sclerosis (ALS) Announced expansion of pipeline- COYA 303; COYA 301 in combination with GLP-1 Receptor Agonist for treatment of inflammatory diseases and filing of new intellectual property portfolio for the combination Financial Highlights FY 2024 Raised $10.0M in a private placement of 1.38M shares of common stock. The majority of investors in the offering were existing institutional shareholders of company Received $5.0 million strategic investment by the Alzheimer’s Drug Discovery Foundation (ADDF) to help support the development of COYA 302 for the treatment of Frontotemporal Dementia (FTD) Received $3.85 million from the previously announced First Amendment and License Agreement with Dr. Reddy’s Laboratories, Inc., which is earmarked for funding the first Phase 2 clinical trial of COYA 302 in ALS in the United States. The original agreement was entered into on December 5, 2023. Upcoming Expected Catalysts for 2025 Q2 2025: Submission of additional nonclinical data to support the start of the COYA-302 Phase 2 trial in patients with...