HOUSTON--(BUSINESS WIRE)--March 16, 2026--
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
-- 1H2026: Peripheral immune profiling in FTD publication.
-- 1H 2026: Longitudinal assessment of biomarkers in ALS publication.
-- 2H 2026: Targeting full enrollment of our ALSTARS Phase 2 trial.
-- 2H 2026: Initiate Phase 2a study evaluating COYA 302 for the treatment
of FTD.
-- 2H 2026: Report additional single cell proteomics data from the
completed ALS and AD Investigator Initiated trials.
-- 2H 2026: Publication of in vivo COYA 303 data in inflammatory animal
model of peripheral and CNS inflammation.
"2025 was a year of meaningful clinical and scientific progress for Coya, " said Dr. Arun Swaminathan, PhD, Chief Executive Officer of Coya Therapeutics. "We advanced COYA 302 across multiple programs and key regulatory milestones, generated encouraging translational data validating our combination-based approach, and strengthened our balance sheet to support execution through our next major clinical milestones. We enter 2026 with strong momentum and a clear path forward to advance our COYA 302 program patients with ALS and FTD."
Dr. Fred Grossman, DO, FAPA, President and Chief Medical Officer of Coya Therapeutics added, "We are encouraged by the continued clinical, regulatory, and scientific momentum across our pipeline, which supports our strategy of targeting immune imbalance and neuroinflammation through regulatory T cell enhancement. We are pleased to be actively enrolling the ALSTARS trial across the US and Canada."
Financial Results
As of December 31, 2025, Coya had cash and cash equivalents of $46.8 million.
Collaboration revenues were $7.9 million for the year ended December 31, 2025, compared to $3.6 million for the year ended December 31, 2024. The increase was primarily due to a $3.6 million increase in License revenue and a $0.7 million increase in R&D services revenue. License revenue totaled $6.7 million for the year ended December 31, 2025, arising from milestone payments received upon FDA acceptance of our IND for COYA 302 for the treatment of ALS and the dosing of the first patient in our ALSTARS trial.
Research and development (R&D) expenses were $16.7 million for the year ended December 31, 2025, compared to $11.9 million for the year ended December 31, 2024. The change was primarily due to a $4.9 million increase in our clinical expenses due to our clinical advancement of COYA 302 in ALS, a $1.4 million increase in internal research and development expenses, and a $0.4 million increase in sponsored research, partially offset by a $1.8 million decrease in our preclinical expenses.
In-process research and development was $2.3 million for the year ended December 31, 2025, compared to $0 for the year ended December 31, 2024. This increase was a result of milestone payments made pursuant to our license agreements which were due upon FDA acceptance of our IND for COYA 302 for the treatment of ALS and FTD and upon the dosing of the first patient in our ALSTARS trial.
General and administrative expenses were $11.4 million for the year ended December 31, 2025, and $8.9 million for the year ended December 31, 2024, a change of approximately $2.5 million. The increase was primarily due to a $1.6 million increase in payroll and employee related benefits, a $0.6 million increase in professional service fees and a $0.3 million increase in our investor and public relations costs.
Net loss was $21.2 million for the year ended December 31, 2025, compared to net loss of $14.9 million for the year ended December 31, 2024.
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 www.coyatherapeutics.com
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 and other neurodegenerative diseases. These mechanisms may have additive or synergistic effects.
Coya is currently conducting the ALSTARS Trial, a Phase 2, randomized, multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of COYA 302 for the treatment of ALS (Identifier: NCT07161999).
COYA 302 is an investigational product not yet approved by the FDA or any other regulatory agency.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this press release that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding: expectations of Coya Therapeutics, Inc. (the "Company") regarding the potential benefits, effectiveness and safety of its product candidates; the Company's ability to advance its product candidates through the preclinical and clinical development processes; the Company's expectations regarding, quality, timing and availability of data from the Company's clinical trials; the timing of announcements, updates and results of the Company's clinical trials and related data; the Company's future results of operations and financial position, including cash runway; and the potential therapeutic benefits and economic value of the Company's product candidates. These forward-looking statements are based on the beliefs of the management of the Company as well as assumptions made by and information currently available to the Company. Such statements reflect the current views of the Company with respect to future events and are subject to known and unknown risks and uncertainties. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. These and other factors that may cause the Company's actual results to differ from current expectations are discussed in the Company's filings with the Securities and Exchange Commission (the "SEC"), including the section titled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2025. You are
cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date this press release is given. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
COYA THERAPEUTICS, INC.
BALANCE SHEETS
December 31,
---------------------------
2025 2024
------------ ------------
Assets
Current assets:
Cash and cash equivalents $ 46,822,786 $ 38,339,762
Prepaids and other current assets 3,116,232 5,968,666
----------- -----------
Total current assets 49,939,018 44,308,428
Fixed assets, net 11,227 38,588
----------- -----------
Total assets $ 49,950,245 $ 44,347,016
=========== ===========
Liabilities and Stockholders'
Equity
Current liabilities:
Accounts payable $ 1,061,122 $ 1,588,128
Accrued expenses 3,612,913 1,388,060
Deferred collaboration revenue 1,197,856 848,286
----------- -----------
Total current liabilities 5,871,891 3,824,474
Deferred collaboration revenue 1,050,124 945,447
----------- -----------
Total liabilities 6,922,015 4,769,921
----------- -----------
Stockholders' equity:
Series A convertible preferred
stock, $0.0001 par value:
10,000,000 shares authorized,
none issued and outstanding as
of December 31, 2025 and 2024 - -
Common stock, $0.0001 par value;
200,000,000 shares authorized;
20,934,456 and 16,707,441 shares
issued and outstanding as of
December 31, 2025 and 2024,
respectively 2,094 1,671
Additional paid-in capital 104,989,413 80,312,594
Accumulated deficit (61,963,277) (40,737,170)
----------- -----------
Total stockholders' equity 43,028,230 39,577,095
----------- -----------
Total liabilities and stockholders'
equity $ 49,950,245 $ 44,347,016
=========== ===========
COYA THERAPEUTICS, INC.
STATEMENTS OF OPERATIONS
Years Ended December 31,
---------------------------
2025 2024
------------ ------------
Collaboration revenue $ 7,945,753 $ 3,554,061
Operating expenses:
Research and development 16,734,549 11,865,654
In-process research and
development 2,289,602 25,000
General and administrative 11,449,466 8,885,757
Depreciation 27,361 27,361
----------- -----------
Total operating expenses 30,500,978 20,803,772
----------- -----------
Loss from operations (22,555,225) (17,249,711)
----------- -----------
Other income:
Other income 1,332,207 1,648,637
----------- -----------
Pre-tax loss (21,223,018) (15,601,074)
Income tax (expense) benefit (3,089) 720,287
----------- -----------
Net loss $(21,226,107) $(14,880,787)
=========== ===========
Share information:
Net loss per share of common stock,
basic and diluted $ (1.27) $ (0.98)
=========== ===========
Weighted-average shares of common
stock outstanding, basic and
diluted 16,730,274 15,238,919
=========== ===========
COYA THERAPEUTICS, INC.
STATEMENTS OF CASH FLOWS
Years Ended December 31,
---------------------------
2025 2024
------------ ------------
Cash flows from operating
activities:
Net loss $(21,226,107) $(14,880,787)
Adjustment to reconcile net loss
to net cash used in operating
activities:
Depreciation 27,361 27,361
Stock-based compensation,
including the issuance of
restricted stock 4,290,315 2,663,539
Acquired in-process research
and development 2,289,602 25,000
Changes in operating assets
and liabilities:
Collaboration receivable - 7,500,000
Prepaids and other current
assets 2,852,434 (4,899,109)
Accounts payable (527,006) 477,450
Accrued expenses 1,099,853 (1,498,215)
Deferred collaboration
revenue 454,247 295,939
----------- -----------
Net cash used in
operating activities (10,739,301) (10,288,822)
----------- -----------
Cash flows from investing
activities:
Purchase of in-process research
and development assets (1,164,602) (25,000)
----------- -----------
Net cash used in
investing activities (1,164,602) (25,000)
----------- -----------
Cash flows from financing
activities:
Proceeds from sale of common
stock, net of offering costs 20,348,653 14,004,381
Payment of financing costs
related to the 2023 Private
Placement - (131,918)
Proceeds from subscription
receivable - 11,250
Proceeds from the exercise of
stock options 38,274 1,975
Proceeds from the exercise of
warrants - 2,141,128
----------- -----------
Net cash provided by
financing activities 20,386,927 16,026,816
----------- -----------
Net increase in cash and
cash equivalents 8,483,024 5,712,994
Cash and cash equivalents as of
beginning of the year 38,339,762 32,626,768
----------- -----------
Cash and cash equivalents as of end
of the year $ 46,822,786 $ 38,339,762
=========== ===========
Supplemental disclosures of
non-cash financing activities:
In-process research and
development costs in accrued
expenses $ 1,125,000 $ -
=========== ===========
View source version on businesswire.com: https://www.businesswire.com/news/home/20260316442841/en/
CONTACT: Investor Contact
David Snyder, CFO
david@coyatherapeutics.com
Media Contacts
Russo Partners
David Schull
David.Schull@russopartnersllc.com
858-717-2310
Rachelle Babb
rachelle.babb@russopartnersllc.com
929-325-7559
(END) Dow Jones Newswires
March 16, 2026 08:00 ET (12:00 GMT)