Coya Therapeutics, Inc.

Coya Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel therapies to enhance the function of regulatory T cells (Tregs) to address neurodegenerative, autoimmune, and metabolic diseases. The company's core business model revolves around three potential therapeutic modalities: Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy, utilizing both ex vivo and in vivo approaches to restore Treg function. The company has funded its operations primarily through the private and public sale of its securities and has not yet generated revenue from product sales ¹.

The company's lead asset, COYA 302, is a Treg-enhancing biologic combining proprietary low-dose interleukin-2 (COYA 301, or LD IL-2) and the immunomodulatory drug CTLA4-Ig. This combination is designed to provide a sustained effect on neurodegenerative disorders by targeting multiple pathways. COYA 302 is considered a "Pipeline in a Product" due to its growing list of indications, including Amyotrophic Lateral Sclerosis (ALS) and Frontotemporal Dementia (FTD) ². The company is currently conducting the ALSTARS Trial, a Phase 2, randomized, multi-center, double-blind, placebo-controlled study to evaluate COYA 302 for ALS ³.

Another significant product candidate is COYA 303, an investigational biologic combination of COYA 301 (LD IL-2) and a glucagon-like-peptide-1 receptor agonist (GLP-1 RA) for the treatment of inflammatory diseases. Preclinical studies of COYA 303 have shown a dual immunomodulatory mechanism, increasing Treg function and suppressing pro-inflammatory myeloid cells and responder T cells ⁴. The company also has COYA 301, a low-dose IL-2 product candidate intended to enhance Treg function and expand Treg numbers in vivo, with investigator-initiated studies in Alzheimer's Disease (AD) showing promising results ⁵.

In the Treg-derived exosome modality, the company is developing COYA 201, an allogeneic Treg exosome product candidate, and COYA 206, a next-generation antigen-directed Treg-derived exosome product candidate utilizing a licensed Exosome Engineering Technology from Carnegie Mellon University ⁶. Preclinical studies for COYA 201 in a lupus nephritis model in mice showed it was well tolerated at a dose of 1x10^10 exosomes, though fatalities were observed at extremely high doses of 1x10^11 exosomes ⁷. COYA 201 also demonstrated biological activity in a human liver microtissue model, significantly decreasing pro-inflammatory cytokines and increasing anti-inflammatory cytokine IL-10 ⁸.

For the fiscal year ended December 31, 2025, the company reported collaboration revenue of $7,945,753 ⁹, an increase from $3,554,061 in 2024 ¹⁰. Operating expenses totaled $30,500,978 ¹¹, leading to a net loss of $21,226,107 ¹². This compares to a net loss of $14,880,787 in 2024 ¹³. Research and development expenses increased by $4.9 million, from $11,865,654 in 2024 ¹⁴ to $16,734,549 in 2025 ¹⁵, primarily due to the clinical advancement of COYA 302 in ALS. General and administrative expenses also rose by $2.5 million, from $8,885,757 in 2024 ¹⁶ to $11,449,466 in 2025 ¹⁷. As of December 31, 2025, cash and cash equivalents stood at $46.8 million ¹⁸, and the accumulated deficit was $62.0 million ¹⁹.

The increase in collaboration revenue was primarily driven by a $3.6 million increase in License revenue and a $0.7 million increase in R&D services revenue ²⁰. Milestone payments of $4.2 million were received upon FDA acceptance of the IND application for COYA 302 for ALS in August 2025 ²¹ and another $4.2 million upon dosing the first patient in the ALSTARS trial in December 2025 ²². In-process research and development expenses were $2,289,602 in 2025 ²³, up from $25,000 in 2024 ²⁴, due to milestone payments related to license agreements upon achieving the IND Milestones and Dosing Milestone.

Significant operational developments include the FDA's acceptance of the IND application for COYA 302 for ALS in August 2025, followed by the commencement of dosing in the ALSTARS Trial in December 2025 ²⁵. In January 2026, the FDA also accepted the IND for COYA 302 for the treatment of Frontotemporal Dementia (FTD) ²⁶. Positive interim results from an investigator-initiated open-label study of low-dose IL-2 and CTLA4-Ig combination treatment in FTD patients were announced in April 2025, with complete results in January 2026 showing enhanced Treg numbers and function and cognitive function stability ²⁷. The company also expanded its investigational pipeline with COYA 303 in January 2025, with preclinical results demonstrating broad systemic and central immunomodulatory activity ²⁸.

The company anticipates completing enrollment in the ALSTARS trial for COYA 302 in ALS in the second half of 2026 ²⁹. Following the January 2026 financing, which generated $11.1 million in gross proceeds ³⁰, the net proceeds are intended to accelerate tech transfer and scale-up manufacturing activities for low dose IL-2 to support the commercial readiness of COYA 302 for ALS ³¹. These initiatives are not expected to impact the current cash runway, which is projected into the second half of 2027 ³².

A major growth area for the company is the advancement of COYA 302, referred to as a "Pipeline in a Product," for ALS and FTD through clinical studies. The company intends to explore the utility of COYA 302 for other neurodegenerative diseases, including Parkinson's Disease (PD) and Alzheimer's Disease (AD), and potentially autoimmune diseases ³³. The FDA accepted the IND for COYA 302 for FTD in January 2026, and the company expects to advance it into a randomized, double-blind, placebo-controlled clinical trial ³⁴.

Another key growth vector is the development of COYA 303 for AD and other neurodegenerative diseases. The company intends to seek business development opportunities and/or grants to advance COYA 303 through IND-enabling studies ³⁵. The strategy also includes establishing COYA 301 (low dose IL-2) as a backbone for combination therapies with other mechanisms, such as CTLA4-Ig (COYA 302), GLP-1 RA (COYA 303), and possibly GM-CSF and other combinations to address various diseases ³⁶.

Operationally, the company expects its research and development expenses to increase significantly over the next several years due to increased personnel costs, including stock-based compensation, and the conduct of clinical trials, particularly later-stage trials, for current and future product candidates ³⁷. General and administrative expenses are also projected to rise to support continued R&D, potential commercialization efforts, and increased costs associated with operating as a public company, including hiring additional personnel and fees for outside consultants, legal support, and accountants ³⁸. If any product candidates receive U.S. regulatory approval, the company anticipates significantly increased expenses for building a sales and marketing team ³⁹.

The company's planned capital allocation includes continued funding of research and development activities for its product candidates and indications. The total funding commitment for the Sponsored Research Agreement with Houston Methodist Research Institute, which was renewed on January 1, 2026, is $0.6 million ⁴⁰. The company will need to raise substantial additional capital to support its continuing operations and growth strategy, planning to finance operations through equity sales, debt financings, or collaborations ⁴¹.

The company faces substantial risks due to its clinical-stage nature, with no products approved for commercial sale and a history of significant losses, including a net loss of $21.2 million for the year ended December 31, 2025 ⁴² and an accumulated deficit of $62.0 million ⁴³. There is a significant need for additional capital, and the inability to secure financing on acceptable terms could limit future clinical trials and product development, threatening long-term viability. Market volatility, inflation, and global economic disruptions, including increased costs of clinical trials and R&D, could accelerate cash consumption faster than the current projection into the second half of 2027 ⁴⁴. The company relies heavily on third-party manufacturers and research institutions, and any disruptions in these relationships, or failure to comply with cGMP requirements, could delay or prevent product development and commercialization. Clinical trials are inherently lengthy, expensive, and uncertain, with potential for delays, failures, or adverse events, such as the observed fatalities in mice at extremely high doses of COYA 201 (1x10^11 exosomes) ⁴⁵, which could halt or delay further development. Furthermore, the company's intellectual property, largely in-licensed, is subject to risks of termination, challenge, or insufficient robustness, potentially allowing competitors to commercialize similar products. Changes in U.S. patent law or the patent law of other jurisdictions could also diminish the value of patents. Cybersecurity threats, though not yet material, pose a risk to sensitive data and operations, potentially leading to disruptions or liabilities.

Management's message emphasizes the company's focus on developing proprietary new therapies to enhance regulatory T cells (Tregs) for neurodegenerative, autoimmune, and metabolic diseases, leveraging three distinct therapeutic modalities: Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy. They highlight COYA 302 as their lead asset, a "Pipeline in a Product," currently in a Phase 2 clinical trial for ALS (ALSTARS Trial, ClinicalTrials.gov Identifier: NCT 07161999) ⁴⁶, with an IND for FTD also accepted by the FDA ⁴⁷. Management explicitly states that the $11.1 million in gross proceeds from the January 2026 Offering ⁴⁸ will be used to accelerate tech transfer and scale-up manufacturing for low dose IL-2 to support COYA 302's commercial readiness for ALS, and that this is not expected to impact the current cash runway into the second half of 2027 ⁴⁹. Key strategic priorities include advancing COYA 302 for ALS and FTD through clinical studies, exploring its utility for other neurodegenerative and autoimmune diseases, developing COYA 303 for AD and other neurodegenerative diseases, establishing COYA 301 as a backbone for combination therapies, actively pursuing partnering opportunities for COYA 301 and COYA 302, and leveraging in-licensed technology to advance exosomes as potential therapies.