COYA

EX-99.1

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EX-99.1

EX-99.1

Exhibit 99.1

Coya Therapeutics Reports Third Quarter 2026 Financial Results and Provides a Corporate Update

HOUSTON--(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 September 30, 2026 and provides a corporate update.

“Completion of enrollment in our Phase 2/3 ALSTARS trial represents a significant achievement for Coya as we advance COYA 302 for the treatment of ALS,” said Arun Swaminathan, Ph.D., Chief Executive Officer of Coya Therapeutics. “With topline data anticipated in early Q2 2027, we remain focused on communicating data from this study as soon as it is available.”

Recent Corporate Highlights

• Completed enrollment of 120 planned participants in the Phase 2/3 ALSTARS trial of COYA 302 for the treatment of ALS. Coya allowed participants in screening to enter the trial. A total of 137 participants were enrolled.

• In response to requests from ALSTARS investigators and study participants, Coya announced plans to initiate an open-label extension (OLE) of the ALSTARS trial, providing participants who complete the 48-week study period the opportunity to continue receiving COYA 302.

• Presented at the 2026 Annual NEALS Meeting Neurofilament Light Chain (NfL) Biomarker Stratification Methodology to Minimize the Impact of Heterogeneity in ALS Clinical Trials

• Announced the publication of preclinical results for COYA 303 in the International Journal of Molecular Sciences demonstrating complementary immunomodulatory effects in a well-established model of peripheral and central nervous system (CNS) inflammation.

Upcoming Expected Milestones

• 4Q 2026-Q1 2027: Report additional mechanistic data and single-cell proteomics data from the completed ALS and AD investigator-initiated trials, subject to publication

• Q1 2027: Announce biomarker data from the completed investigator-initiated study in patients with frontotemporal dementia (FTD).

• Early Q2 2027: Report topline data from 24-week double-blind treatment phase of the Phase 2/3 ALSTARS trial of COYA 302 for the treatment of ALS.

• 2027: Initiate a Phase 2 study evaluating COYA 302 for the treatment of FTD.

“Completion of the ALSTARS trial is an important milestone as we move forward in our quest for providing a potential therapy for this lethal disease,” said Fred Grossman, DO, FAPA, President and Chief Medical Officer of Coya Therapeutics. “The addition of the open-label extension provides

participants the opportunity to continue on COYA 302 while we continue to collect important data.”

Financial Results

As of September 30, 2026, Coya had cash and cash equivalents of $35.8 million, sufficient to fund operations, as currently planned, past the Phase 2/3 ALSTARS topline data readout and into the second half of 2027.

R&D Services revenue is calculated quarterly using the inputs approach, by applying actual COYA 302 - ALS expenses against budgeted COYA 302 - ALS expenses as the two inputs. Collaboration revenue of $0.2 million during the three months ended September 30, 2026, consisted of R&D Services. Collaboration revenue of $3.6 million during the three months ended September 30, 2025, consisted primarily of the immediate recognition of $3.3 million of License revenue upon receiving FDA acceptance of our IND for the Phase 2/3 ALSTARS Study and $0.3 million of R&D Services.

Research and development expenses increased by $5.7 million from $2.9 million for the three months ended September 30, 2025, to $8.6 million for the three months ended September 30, 2026. The increase was primarily due to a $5.6 million increase in preclinical and clinical product candidate costs, reflecting primarily the advancement of the COYA 302 ALS Phase 2/3 clinical trial. The increase was further driven by a $0.1 million increase in internal research and development expenses.

In-process research and development was $23,240 and $0.5 million for the three months ended September 30, 2026, and 2025, respectively. The $0.5 million was a result of milestone payments pursuant to our license agreements which were due upon the achievement of the FDA's approval of our IND of COYA 302 in patients with ALS. Milestone payments pursuant to our license agreements were not incurred during the three months ended September 30, 2026.

General and administrative expenses were $2.6 million for both the three months ended September 30, 2026, and 2025.

Net loss was $10.6 million for the three months ended September 30, 2026, compared to net loss of $2.1 million for the three months ended September 30, 2025.

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 regulat

8-K

0001835022false00018350222026-08-112026-08-11

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 11, 2026

Coya Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware

001-41583

85-4017781

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

5850 San Felipe St., Suite 500

Houston, Texas

77057

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: 800 587-8170

N/A

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.0001 per share

COYA

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition. On August 11, 2026, Coya Therapeutics, Inc. (the “Company”) issued a press release disclosing certain information regarding its results of operations for the fiscal quarter ended June 30, 2026. A copy of the press release is furnished under Item 2.02 of this Current Report on Form 8-K as Exhibit 99.1.

The information included in this Item 2.02, and Exhibit 99.1 to this Current Report on Form 8-K, shall not be deemed “filed” for the purposes of or otherwise subject to the liabilities under Section 18 of the Securities Exchange Act of 1934 as amended (the “Exchange Act”). Unless expressly incorporated into a filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act made after the date hereof, the information contained in this Item 2.02 and Exhibit 99.1 hereto shall not be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item 9.01 Financial Statements and Exhibits. (d) Exhibits.

Exhibit No.

Description

99.1

Press Release dated August 11, 2026.

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

COYA THERAPEUTICS, INC.

Date:

August 11, 2026

By:

/s/ Arun Swaminathan Ph.D.

Arun Swaminathan Ph.D. Chief Executive Officer (Principal Executive Officer)

EX-99.1

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EX-99.1

EX-99.1

Coya Therapeutics Reports First Quarter 2026 Financial Results and Provides a Corporate Update

HOUSTON, TX., 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 March 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 for 2026

• June 2026: Scientific presentations at upcoming 5th Annual ALS Drug Development Summit and ENCALS (European Network to Cure ALS)

• 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 COYA 303 in vivo data in inflammatory animal model of peripheral and CNS inflammation.

Fred Grossman, DO, FAPA, President and Chief Medical Officer of Coya, added, “The recent revision to our inclusion/exclusion criteria [for our ALSTARS protocol] has expanded the patient population to study this potential therapy for ALS. We expect that this change will also increase the recruitment rate,” said Fred Grossman, DO, FAPA, President and Chief Medical Officer of Coya. “We continue to strengthen the biological foundation of our approach as we believe the investigator-initiated study findings and publications noted above highlight the role of immune dysregulation and systemic inflammation in FTD and ALS, and reinforce the promising potential of COYA 302 to modulate these pathways and impact disease progression.”

Financial Results

As of March 31, 2026, Coya had cash and cash equivalents of $50.7 million.

Collaboration revenue was $0.3 million for each of the three months ended March 31, 2026 and 2025, and related to the Company’s R&D services performance obligation under the Development and License Agreement with DRL.

Research and development expenses decreased by $1.1 million, from $5.2 million for the three months ended March 31, 2025, to $4.1 million for the three months ended March 31, 2026. The decrease was primarily due to a $1.2 million decrease in external preclinical and clinical product candidates, reflecting the timing of preclinical activities undertaken in early 2025 to support the Company’s Investigational New Drug applications for COYA 302 in ALS. The decrease was further driven by a $0.1 million decrease in sponsored research expense, partially offset by a $0.2 million increase in internal research and development expenses.

General and administrative expenses increased by $1.1 million, from $2.7 million for the three months ended March 31, 2025, compared to $3.4 million for the three months ended March 31, 2026. The increase was primarily