STOCK TITAN

Coya Therapeutics (NASDAQ: COYA) details Q2 2026 results, ALS Fast Track and cash runway

(Moderate)
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Coya Therapeutics, Inc. reported second quarter 2026 results and highlighted progress on its lead program COYA 302 for ALS and frontotemporal dementia. Enrollment in the Phase 2 ALSTARS ALS trial is proceeding as planned, with completion targeted in 2026 and topline data expected in the first quarter of 2027. The company also plans to initiate a Phase 2 study of COYA 302 in frontotemporal dementia in the second half of 2026.

Coya received FDA Fast Track Designation for COYA 302 in ALS and reported collaboration revenue of $243,745 for the quarter. Research and development expenses were $5.0 million, reflecting advancement of the COYA 302 ALS Phase 2 trial, while general and administrative expenses declined to $2.3 million. Net loss was $6.6 million. As of June 30, 2026, Coya held $43.2 million in cash and cash equivalents, which it states is sufficient to fund operations, as currently planned, past the ALSTARS topline readout and into the second half of 2027.

Positive

  • FDA Fast Track Designation for COYA 302 in ALS may expedite development and review of this lead asset.
  • Cash and cash equivalents of $43.2 million are expected to fund operations past Phase 2 ALSTARS topline data and into 2H 2027.
  • General and administrative expenses decreased to $2.3 million from $2.9 million year over year, reflecting lower professional and compensation costs.

Negative

  • Net cash used in operating activities rose to $13.6 million for the first half of 2026 from $8.6 million a year earlier, indicating higher cash burn.

Filing Explained

The filing reports 23,457,849 common shares issued and outstanding as of June 30, 2026, versus 20,934,456 as of December 31, 2025, alongside $10,953,604 in net proceeds from common-stock sales. The higher share count reduces an existing holder’s percentage ownership absent offsetting changes.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Collaboration revenue Q2 2026 $243,745 Three months ended June 30, 2026
Research and development expenses Q2 2026 $5,030,667 Three months ended June 30, 2026
General and administrative expenses Q2 2026 $2,255,603 Three months ended June 30, 2026
Net loss Q2 2026 $6,638,260 Three months ended June 30, 2026
Cash and cash equivalents $43,181,002 As of June 30, 2026
Net cash used in operating activities $13,584,446 Six months ended June 30, 2026
Common shares outstanding 23,457,849 As of June 30, 2026
Proceeds from sale of common stock $10,953,604 Six months ended June 30, 2026, net of offering costs
Fast Track Designation regulatory
"Received FDA Fast Track Designation for COYA 302 for the treatment of ALS."
Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.
ALSTARS Phase 2 trial medical
"the first cohort of patients has progressed into the 24-week blinded active treatment extension phase in the ALSTARS Phase 2 Trial."
regulatory T cells medical
"treatments focused on the biology and potential therapeutic advantages of regulatory T cells (“Tregs”)"
Regulatory T cells are a specialized type of immune cell that act like a brake on the body’s defense system, preventing it from attacking healthy tissue or causing chronic inflammation. They matter to investors because drugs that increase or block these cells can change treatment success and safety in areas such as autoimmune disease, organ transplants, and cancer immunotherapy, affecting clinical trial results, approval chances, and commercial value.
deferred collaboration revenue financial
"Deferred collaboration revenue | | | 1,233,452"
ATM Offering Program financial
"Payment of financing costs related to the ATM Offering Program"
An ATM offering program (short for “at-the-market” offering) lets a company sell newly issued shares directly into the public market at prevailing prices over time, rather than all at once. It matters to investors because it provides a flexible way for the company to raise cash when conditions are favorable, but it can increase the number of shares available and dilute existing ownership, which may affect the stock’s price and earnings per share. An everyday analogy is a baker adding extra loaves to a shop shelf throughout the day at whatever the current price is.
Treg-derived exosomes medical
"Coya’s therapeutic platforms include Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy."
Collaboration revenue $243,745 Higher than $163,616 in the prior-year quarter
Research and development expenses $5,030,667 Increased from $3,663,103 in the prior-year quarter
General and administrative expenses $2,255,603 Decreased from $2,908,191 in the prior-year quarter
Net loss $6,638,260 Slightly higher than $6,094,977 in the prior-year quarter
Cash and cash equivalents $43,181,002 Down from $46,822,786 at December 31, 2025
Guidance

The company expects existing cash to fund operations, as currently planned, past the Phase 2 ALSTARS topline data readout and into the second half of 2027.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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FAQ

What were Coya Therapeutics (COYA) second quarter 2026 revenues?

Coya Therapeutics reported collaboration revenue of $243,745 for the three months ended June 30, 2026, compared with $163,616 for the same period in 2025, all related to its Development and License Agreement with DRL.

How much cash does Coya Therapeutics (COYA) have and what is its runway?

As of June 30, 2026, Coya held $43.2 million in cash and cash equivalents. The company states this is sufficient to fund operations, as currently planned, past the Phase 2 ALSTARS topline data readout and into the second half of 2027.

What were Coya Therapeutics (COYA) R&D and G&A expenses in Q2 2026?

For the quarter ended June 30, 2026, research and development expenses were $5,030,667, driven mainly by the COYA 302 ALS Phase 2 trial, while general and administrative expenses declined to $2,255,603 from $2,908,191 in the prior-year quarter.

What was Coya Therapeutics (COYA) net loss and EPS for Q2 2026?

Net loss for the three months ended June 30, 2026 was $6,638,260, compared with $6,094,977 a year earlier. Basic and diluted net loss per share of common stock was $(0.28), versus $(0.36) in the prior-year period.

What key clinical milestones did Coya Therapeutics (COYA) outline?

Coya expects in 2H 2026 to complete ALSTARS Phase 2 enrollment, initiate a Phase 2 FTD study with COYA 302, release FTD biomarker data, report additional ALS and AD proteomics data, and publish in vivo data on COYA 303.

Did Coya Therapeutics (COYA) raise capital in 2026 year to date?

Yes. For the six months ended June 30, 2026, Coya received $10,953,604 in net proceeds from the sale of common stock and recorded $124,286 of financing costs related to its ATM Offering Program.
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)

 


 

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

HOUSTON, TX., August 11, 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 June 30, 2026 and provides a corporate update.

“During the second quarter, we made notable progress advancing our lead program, COYA 302,” said Arun Swaminathan, Ph.D., Chief Executive Officer of Coya. “Enrollment in the ALSTARS Phase 2 ALS trial is proceeding as planned, and we remain on track to complete enrollment this year and report topline data in the first quarter of 2027. At the same time, we plan to initiate a Phase 2 study of COYA 302 in frontotemporal dementia (FTD) in the coming months. Together, these programs reflect our differentiated strategy of applying Treg biology to address the shared mechanisms of these neurodegenerative conditions.”

Recent Corporate Highlights

Announced that the first cohort of patients has progressed into the 24-week blinded active treatment extension phase in the ALSTARS Phase 2 Trial.
Received FDA Fast Track Designation for COYA 302 for the treatment of ALS. Fast Track Designation is intended to facilitate the development and expedite the review of drugs that treat serious conditions and address unmet medical needs.
Appointed Mark H. Pavao as Independent Director.
Announced a publication in the journal Annals of Clinical and Translational Neurology demonstrating the correlation between longitudinal biomarker data and clinical outcomes supporting the mechanistic rationale for COYA 302 in patients with ALS.
Delivered scientific presentations on the ALSTARS Phase 2 clinical trial design at the 5th Annual ALS Drug Development Summit and ENCALS (European Network to Cure ALS) Meeting 2026.
Hosted a virtual webinar titled, ‘Beyond the Hit: How Repetitive Head Trauma, Inflammation, and Neurodegenerative Disease Intersect’, which explored the relationship between repetitive head trauma, brain inflammation and neurodegenerative diseases with leading experts in the field.

Upcoming Expected Milestones 2026:

 

 


 

2H 2026: Complete enrollment in the ALSTARS Phase 2 trial.
2H 2026: Initiate a Phase 2 study evaluating COYA 302 for the treatment of FTD.
2H 2026: Announce biomarker data from the completed investigator-initiated study in patients with FTD
2H 2026: Report additional single-cell proteomics data from the completed ALS and AD investigator-initiated trials.
2H 2026: Publish in vivo data on COYA 303 in an inflammatory animal model of peripheral and CNS inflammation.

 

“The progress we have made in the ALSTARS trial continues to reinforce our confidence in COYA 302 as we advance this program for people living with ALS,” said Fred Grossman, DO, FAPA, President and Chief Medical Officer of Coya. “The blinded extension phase of the ALSTARS trial is now well underway. We are grateful to the patients, families, and investigators whose partnership makes this work possible.”

Financial Results

As of June 30, 2026, Coya had cash and cash equivalents of $43.2 million, sufficient to fund operations, as currently planned, past the Phase 2 ALSTARS topline data readout and into the second half of 2027.

Collaboration revenue was $0.2 million for each of the three months ended June 30, 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 increased by $1.3 million from $3.7 million for the three months ended June 30, 2025 to $5.0 million for the three months ended June 30, 2026. The increase was primarily due to a $1.1 million increase in preclinical and clinical product candidate costs, reflecting primarily the advancement of the COYA 302 ALS Phase 2 clinical trial. The increase was further driven by a $0.4 million increase in internal research and development expenses, partially offset by a $0.2 million decrease in sponsored research expense.

General and administrative expenses decreased by $0.6 million from $2.9 million for the three months ended June 30, 2025 compared to $2.3 million for the three months ended June 30, 2026. The decrease was primarily due to a $0.4 million decrease in professional services and a $0.2 million decrease in employee compensation, including lower stock-based compensation.

 

 


 

Net loss was $6.6 million for the three months ended June 30, 2026, compared to net loss of $6.1 million for the three months ended June 30, 2025.

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, FTD 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 significance and potential benefits associated with the FDA’s Fast Track designation for COYA 302; 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.

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

Source: Coya Therapeutics, Inc.

 

 


 

COYA THERAPEUTICS, INC.

CONDENSED BALANCE SHEETS

 

 

(unaudited)

 

 

 

 

 

June 30,

 

 

December 31,

 

 

2026

 

 

2025

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

43,181,002

 

 

$

46,822,786

 

Prepaids and other current assets

 

 

3,876,735

 

 

 

3,116,232

 

Total current assets

 

 

47,057,737

 

 

 

49,939,018

 

Fixed assets, net

 

 

5,614

 

 

 

11,227

 

Other assets

 

 

244,727

 

 

 

-

 

Total assets

 

$

47,308,078

 

 

$

49,950,245

 

 

 

 

 

 

 

Liabilities and Stockholders' Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

1,085,519

 

 

$

1,061,122

 

Accrued expenses

 

 

1,193,460

 

 

 

3,612,913

 

Deferred collaboration revenue

 

 

1,233,452

 

 

 

1,197,856

 

Total current liabilities

 

 

3,512,431

 

 

 

5,871,891

 

Deferred collaboration revenue

 

 

519,636

 

 

 

1,050,124

 

Total liabilities

 

 

4,032,067

 

 

 

6,922,015

 

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

Series A convertible preferred stock, $0.0001 par value: 10,000,000 shares authorized, none issued or outstanding as of June 30, 2026 or December 31, 2025

 

 

-

 

 

 

-

 

Common stock, $0.0001 par value; 200,000,000 shares authorized; 23,457,849 and 20,934,456 shares issued and outstanding as of June 30, 2026 or December 31, 2025, respectively

 

 

2,346

 

 

 

2,094

 

Additional paid-in capital

 

 

119,082,192

 

 

 

104,989,413

 

Accumulated deficit

 

 

(75,808,527

)

 

 

(61,963,277

)

Total stockholders' equity

 

 

43,276,011

 

 

 

43,028,230

 

Total liabilities and stockholders' equity

 

$

47,308,078

 

 

$

49,950,245

 


 

 


 

COYA THERAPEUTICS, INC.

CONDENSED UNAUDITED INTERIM STATEMENTS OF OPERATIONS

 

Three Months Ended June 30,

 

 

2026

 

 

2025

 

Collaboration revenue

 

$

243,745

 

 

$

163,616

 

Operating expenses:

 

 

 

 

 

 

Research and development

 

 

5,030,667

 

 

 

3,663,103

 

In-process research and development

 

 

1,656

 

 

 

-

 

General and administrative

 

 

2,255,603

 

 

 

2,908,191

 

Depreciation

 

 

2,807

 

 

 

6,840

 

Total operating expenses

 

 

7,290,733

 

 

 

6,578,134

 

Loss from operations

 

 

(7,046,988

)

 

 

(6,414,518

)

Other income:

 

 

 

 

 

 

Other income

 

 

408,728

 

 

 

319,541

 

Pre-tax loss

 

 

(6,638,260

)

 

 

(6,094,977

)

Income tax expense

 

 

-

 

 

 

-

 

Net loss

 

$

(6,638,260

)

 

$

(6,094,977

)

 

 

 

 

 

 

Per share information:

 

 

 

 

 

 

Net loss per share of common stock, basic and diluted

 

$

(0.28

)

 

$

(0.36

)

Weighted-average shares of common stock outstanding, basic and diluted

 

 

23,457,227

 

 

 

16,724,998

 

 

 

 


 

COYA THERAPEUTICS, INC.

CONDENSED UNAUDITED INTERIM STATEMENTS OF CASH FLOWS

 

Six Months Ended June 30,

 

 

2026

 

 

2025

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(13,845,250

)

 

$

(13,401,734

)

Adjustment to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Depreciation

 

 

5,614

 

 

 

13,680

 

Stock-based compensation, including the issuance of restricted stock

 

 

3,139,427

 

 

 

2,115,795

 

Acquired in-process research and development assets

 

 

11,656

 

 

 

-

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Prepaids and other current assets

 

 

(640,062

)

 

 

2,298,347

 

Other assets

 

 

(120,441

)

 

 

-

 

Accounts payable

 

 

(96,044

)

 

 

(656,784

)

Accrued expenses

 

 

(1,544,454

)

 

 

1,450,625

 

Deferred collaboration revenue

 

 

(494,892

)

 

 

(421,500

)

Net cash used in operating activities

 

 

(13,584,446

)

 

 

(8,601,571

)

Cash flows from investing activities:

 

 

 

 

 

 

Purchase of in-process research and development assets

 

 

(886,656

)

 

 

-

 

Net cash used in investing activities

 

 

(886,656

)

 

 

-

 

Cash flows from financing activities:

 

 

 

 

 

 

Proceeds from sale of common stock, net of offering costs

 

 

10,953,604

 

 

 

-

 

Payment of financing costs related to the ATM Offering Program

 

 

(124,286

)

 

 

-

 

Proceeds from the exercise of stock options

 

 

-

 

 

 

19,137

 

Net cash provided by financing activities

 

 

10,829,318

 

 

 

19,137

 

Net decrease in cash and cash equivalents

 

 

(3,641,784

)

 

 

(8,582,434

)

Cash and cash equivalents as of beginning of the period

 

 

46,822,786

 

 

 

38,339,762

 

Cash and cash equivalents as of end of the period

 

$

43,181,002

 

 

$

29,757,328

 

 

 

 

 

 

 

Supplemental disclosures of non-cash investing and financing activities:

 

 

 

 

 

In-process research and development costs in accrued expenses

 

$

250,000

 

 

$

-

 

Financing costs related to the ATM Offering Program in accounts payable

 

$

120,441

 

 

$

-

 



 


 

 

 

 


Filing Exhibits & Attachments

2 documents