COYA-301

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 cell enhancement approach, including the recent findings from the investigator-initiated trial in FTD and promising pre-clinical results with COYA 303. These advances strengthen our confidence in the potential of COYA 302 in neurodegenerative diseases like ALS and FTD." Coya's Chief Medical Officer Dr. Fred Grossman commented, "We look forward to the FDA's decision on our IND submission for COYA 302 in ALS, which represents a significant milestone for our lead program. Pending clearance, we are prepared to initiate our controlled Phase 2 clinical trial in ALS. We also plan to submit an IND for FTD by the end of the year." Financial Results As of June 30, 2025, Coya had cash and cash equivalents of $29.8 million. Collaboration revenues were $0.2 million for the three months ended June 30, 2025, compared to $3.4 million for the three months ended June 30, 2024, a change of approximately $3.3 million. The decrease was primarily due to the immediate recognition of license revenue upon executing the First Amendment to the DRL Development Agreement during the three months ended June 30, 2024. Research and development expenses were $3.7 million for the three months ended June 30, 2025, compared to $4.6 million for the three months ended June 30, 2024, a decrease of approximately $0.9 million. The decrease was primarily due to a $1.2 million decrease in our preclinical expenses primarily due to our preclinical work on COYA 302 in ALS, partially offset by a $0.2 million increase in internal research and development expenses, and a $0.1 million increase in sponsored research. General and administrative expenses were $2.9 million for the three months ended June 30, 2025, and $2.1 million for the three months ended June 30, 2024, an increase e of approximately $0.8 million. The increase was primarily due to a $0.3 million increase in stock-based compensation, a $0.4 million increase in professional services, and a $0.1 million increase in investor relation related expenses. Net loss was $6.1 million for the three months ended June 30, 2025, compared to net loss of $2.9 million for the three months ended June 30, 2024. About COYA 302 COYA 302 is an investigational and proprietary biologic combination therapy with a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of regulatory T cells (Tregs) and suppress the inflammation produced by activated monocytes and macrophages. COYA 302 comprises proprietary low dose interleukin-2 (LD IL-2) and CTLA-4 Ig and is being developed for subcutaneous administration for the treatment of patients with ALS. These mechanisms may have additive or synergistic effects. COYA 302 is an investigational product not yet approved by the FDA or any other regulatory agency. About COYA 303 COYA 303 is an investigational biologic combination of COYA 301 and a glucagon-like-peptide-1 receptor agonist (GLP-1 RA) designed for subcutaneous administration. In a preclinical study, COYA 303 exhibited a dual immunomodulatory mechanism of action resulting in an additive/synergistic anti-inflammatory effect, which the Company believes was due to increased Treg function and suppressed pro-inflammatory myeloid cells and responder T cells. About Coya Therapeutics, Inc. Headquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq: COYA) is a clinical-stage biotechnology company developing proprietary treatments focused on the biology and potential therapeutic advantages of regulatory T cells ("Tregs") to target systemic inflammation and neuroinflammation. Dysfunctional Tregs underlie numerous conditions, including neurodegenerative, metabolic, and autoimmune diseases. This cellular dysfunction may lead to sustained inflammation and oxidative stress resulting in lack of homeostasis of the immune system. Coya's investigational product candidate pipeline leverages multiple therapeutic modalities aimed at restoring the anti-inflammatory and immunomodulatory functions of Tregs. Coya's therapeutic platforms include Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy. For more information about Coya, please visit Forward-Looking Statements This press release contains "forward-looking" statements that are based on our management's beliefs and assumptions and on information currently available to management. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our current and future financial performance, business plans and objectives, current and future clinical and preclinical development activities, timing and success of our ongoing and planned clinical trials and related data, the timing of announcements, updates and results of our clinical trials and related data, our ability to obtain and maintain regulatory approval, the potential therapeutic benefits and economic value of our product candidates, competitive position, industry environment and potential market opportunities. The words "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," and similar expressions are intended to identify forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors including, but not limited to, those related to risks associated with the impact of COVID-19; the success, cost and timing of our product candidate development activities and ongoing and planned clinical trials; our plans to develop and commercialize targeted therapeutics; the progress of patient enrollment and dosing in our preclinical or clinical trials; the ability of our product candidates to achieve applicable endpoints in the clinical trials; the safety profile of our product candidates; the potential for data from our clinical trials to support a marketing application, as well as the timing of these events; our ability to obtain funding for our operations; development and commercialization of our product candidates; the timing of and our ability to obtain and maintain regulatory approvals; the rate and degree of market acceptance and clinical utility of our product candidates; the size and growth potential of the markets for our product candidates, and our ability to serve those markets; our commercialization, marketing and manufacturing capabilities and strategy; future agreements with third parties in connection with the commercialization of our product candidates; our expectations regarding our ability to obtain and maintain intellectual property protection; our dependence on third party manufacturers; the success of competing therapies or products that are or may become available; our ability to attract and retain key scientific or management personnel; our ability to identify additional product candidates with significant commercial potential consistent with our commercial objectives; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. Moreover, we operate in a very competitive and rapidly changing environment, and new risks may emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed herein may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Although our management believes that the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances described in the forward-looking statements will be achieved or occur. We undertake no obligation to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Investor Contact David Snyder, CFO [email protected] astr partners Matthew Beck [email protected] 917-415-1750 Media Contacts Russo Partners Olipriya Das [email protected] 646-942-5588 Matthew Purcell [email protected] 646-942-5595 SOURCE Coya Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The delay hits the biotech in an early stage of drug development in which companies submit preclinical data to the FDA and request to into human studies.\n The FDA has missed the date for Coya Therapeutics’ investigational new drug (IND) application, citing a lack of resources and its current workload as reasons for the delay, according to a legal filing from the biotech.On July 29, the federal drug agency told Coya it would not meet the initial review goal date of July 30, according to a Securities and Exchange Commission filing from the Houston-based biotech. If approved, the IND application would allow Coya to launch a phase 2 trial for its investigational amyotrophic lateral sclerosis (ALS) treatment.The FDA said it would deliver a decision before or by Aug. 29, according to the filing.As of publication Thursday morning, the FDA has not responded to Fierce Biotech’s request for comment.The delay hits the biotech in an early stage of drug development in which companies submit preclinical data to the FDA and request to move the candidate into human studies.For Coya, the delay will stretch out the time—and the company’s cash runway—that the biotech must wait to see if it can start clinical trials for COYA 302, its lead biologic investigational product that the biotech dubs a \"pipeline in a product.\"The asset is a combination of Coya’s LD IL-2 candidate called COYA 301, plus a CTLA4-Ig, for the potential treatment of ALS, dementia, Parkinson’s disease and Alzheimer’s disease.As of March 31, Coya had $35.5 million on hand, according to first-quarter earnings.Small biotechs are typically tight on cash, with operations and funding plans tied to agency approvals and requirements.In April, more than 200 biotech leaders penned a letter expressing concern over the FDA’s capacity after mass federal layoffs, specifically for small biotechs that depend on investor backing to meet agency standards. Under President Donald Trump, the FDA has undergone an extreme overhaul, losing at least 3,500 full-time employees and a large portion of the agency’s former leadership.At the time of the mass layoffs, the Department of Health and Human Services said the workforce reduction “will not affect drug, medical device or food reviewers, nor will it impact inspectors.”  In June, Trump’s pick for FDA Commissioner, Marty Makary, M.D., said the agency was “on track to meet all the PDUFA targets and that morale is good and improving at the agency.”The leader said this two days after KalVista Pharmaceuticals announced that the FDA said it would miss the biotech’s June 17 PDUFA date due to “heavy workload and limited resources.” The Cambridge, Mass.-based biotech had been expecting the FDA to either approve or reject the company’s oral plasma kallikrein inhibitor, sebetralstat, for hereditary angioedema (HAE). But the FDA informed the company that it could have to wait up to four weeks for the agency to make the call. On July 7, the biotech said the agency had approved its drug under the brand name Ekterly as a new, oral treatment option for acute attacks of HAE.    The newly restructured agency has also missed approval decision deadlines for GSK’s IL-5 antibody Nucala, Novavax’s protein-based COVID-19 vaccine, and Stealth BioTherapeutics’ ultrarare genetic disease candidate.