Every 8-K that Coya Therapeutics, Inc. (COYA) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow COYA and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full COYA filings page.
Coya Therapeutics, Inc. (COYA) reports that the 100th patient has been enrolled in its ongoing Phase 2/3 ALSTARS Trial (NCT07161999) evaluating COYA 302, a combination of proprietary low-dose IL-2 and CTLA-4 Ig, for the treatment of amyotrophic lateral sclerosis (ALS).
The company plans to enroll approximately 120 participants, randomized 1:1:1 to two COYA 302 dosing regimens or placebo over a 24-week double-blind phase, followed by a 24-week blinded active-treatment extension, providing up to 48 weeks of COYA 302 data. Based on current trends, Coya anticipates completing enrollment in time to report topline data in early Q2 2027. The primary endpoint is change in disease severity from baseline to Week 24 using ALSFRS-R, with additional objectives including efficacy, safety, tolerability, biological activity and biomarker levels.
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.
Coya Therapeutics, Inc. submitted an amendment to its March 29, 2026 current report that had announced the appointment of Mark H. Pavao to its Board of Directors, effective April 1, 2026. At that time, the Board had not yet determined any committee assignments for him.
The company now states that on August 6, 2026 its Board, acting on a recommendation from the Nominating and Corporate Governance Committee, appointed Mr. Pavao to the Audit Committee, effective immediately. Following this decision, the Audit Committee members are Dr. Dov Goldstein (Chair), Dr. Ann Lee, Dieter Weinand and Mark H. Pavao.
Coya Therapeutics, Inc. reported the results of its Annual Meeting of Stockholders held on June 25, 2026. Stockholders elected two Class I directors to new three-year terms and ratified the company’s independent auditor for the 2026 fiscal year.
Secretary Wilbur Ross received 9,168,496 votes for and 2,818,233 withheld, with 4,585,732 broker non-votes. Dieter Weinand received 10,566,702 votes for and 1,420,027 withheld, with the same 4,585,732 broker non-votes. Stockholders also ratified Weaver and Tidwell, L.L.P. as the independent registered public accounting firm with 16,545,887 votes for, 22,661 against, and 3,913 abstentions.
Coya Therapeutics, Inc. entered into a Sales Agreement with Leerink Partners LLC that allows the company to sell shares of its common stock from time to time in "at the market" offerings for aggregate gross proceeds of up to $30,000,000.
The shares will be issued under an effective Form S-3 shelf registration statement and a prospectus supplement dated May 12, 2026. Leerink Partners will act as sales agent or, if separately agreed, as principal, and will receive a 3.0% commission on gross proceeds from any shares it sells.
Coya may suspend or terminate the program at any time, and the Sales Agreement will also end once all authorized shares are sold or if either party terminates it under the agreement’s terms.
Coya Therapeutics reports first-quarter 2026 results and highlights FDA Fast Track Designation for COYA 302 in amyotrophic lateral sclerosis. Cash and cash equivalents were $50.7 million as of March 31, 2026, after a recent $11.0 million private placement.
Collaboration revenue was $0.25 million, similar to the prior-year quarter. Research and development expense fell to $4.1 million from $5.2 million, while general and administrative expense rose to $3.8 million, mainly from a $1.0 million non-cash stock option modification. Net loss was $7.2 million, roughly flat year over year.
The company advanced its COYA 302 program, including Fast Track Designation, IND acceptance for frontotemporal dementia, protocol changes to broaden Phase 2 ALS trial enrollment, and multiple planned data and trial milestones in the second half of 2026.
Coya Therapeutics, Inc. announced a planned board transition in which founder Howard Berman, Ph.D., resigned as Executive Chairman and director effective April 1, 2026, under a Separation and General Release Agreement that provides a prorated 2026 bonus, COBRA premium coverage and extended stock option vesting and exercise periods.
The board appointed biopharmaceutical executive Mark H. Pavao as an independent Class III director, effective April 1, 2026, with a term running to the 2028 annual meeting and a grant of options to purchase 10,000 shares vesting after one year, alongside standard non‑employee director compensation.
Coya Therapeutics reported full-year 2025 results alongside a broad corporate update. Collaboration revenue rose to $7.9M from $3.6M, mainly from $6.7M of license milestones tied to its COYA 302 ALS program. Operating expenses increased to $30.5M, driven by higher clinical and R&D spending and greater general and administrative costs.
Net loss widened to $21.2M from $14.9M, reflecting heavier investment in development. Cash and cash equivalents were $46.8M at year-end. The company completed a $23.0M upsized public offering and an $11.1M private placement, extending its stated cash runway into the second half of 2027.
Coya advanced COYA 302 into the ALSTARS Phase 2 ALS trial across roughly 25 sites in the U.S. and Canada, received FDA and Health Canada clearances for new indications, and reported supportive translational and preclinical data for COYA 302 and COYA 303. Multiple clinical and publication milestones are targeted through 2026.
Coya Therapeutics, Inc. entered into a securities purchase agreement for a private placement of 2,522,727 common shares at $4.40 per share, raising approximately $11.1 million in gross proceeds. The investors are Dr. Reddy’s Labs, contributing $10.0 million, and Greenlight Capital, an existing institutional stockholder, contributing $1.1 million.
The company plans to use the net proceeds to transfer and scale manufacturing of low dose IL‑2 and accelerate manufacturing programs needed for commercial readiness of COYA 302. Management states these funds are expected to support accelerated commercial readiness plans while reiterating cash runway guidance into the second half of 2027 and past the projected topline for the ALSTARS trial.
Coya Therapeutics, Inc. filed a current report describing a stockholder letter that updates its financial position and key clinical milestone timing. The company reported an unaudited cash balance of $46.8 million as of December 31, 2025, and stated it has a projected cash runway into the second half of 2027, indicating it currently expects to fund operations for an extended period. Coya also noted that it expects a topline data readout from its ongoing ALSTARS Phase 2 trial in the first quarter of 2027, giving investors a timeframe for when important clinical results may become available.
Coya Therapeutics reported early clinical data from an investigator-initiated, open-label proof-of-concept study using a combination of low-dose IL-2 and CTLA4-Ig in 9 patients with Frontotemporal Dementia over about six months. Patients received subcutaneous CTLA4-Ig plus a 5-day course of low-dose IL-2 every four weeks for a total of 22 weeks of dosing and follow-up.
The treatment was generally well tolerated: the most common side effect was mild injection-site redness in 33.3% of individuals, and no serious adverse events were observed. Measures of regulatory T cell (Treg) activity and markers such as CD25 and FOXP3 showed significant increases as early as two weeks after dosing and remained elevated through week 22.
Cognitive outcomes, measured by Montreal Cognitive Assessment and CDR-FTLD scores, were essentially stable from baseline (MOCA 13.5; CDR-FTLD 4.8) to week 22 (MOCA 14; CDR-FTLD 5.5), suggesting no notable decline in cognitive or functional status over the treatment period in this small group.
Coya Therapeutics, Inc. received a $4.2 million milestone payment under its Development and License Agreement with Dr. Reddy’s Laboratories Ltd. and Dr. Reddy’s Laboratories SA.
The payment was triggered when the first patient was dosed in Coya’s ALSTARS clinical trial evaluating COYA 302 for the treatment of amyotrophic lateral sclerosis (ALS). The first patient dosing in ALSTARS was previously announced on December 9, 2025, marking a key development step for the COYA 302 ALS program.
Coya Therapeutics, Inc. filed a current report to note that it issued a press release on November 12, 2025 disclosing information about its results of operations for the fiscal quarter ended September 30, 2025. The press release is furnished as Exhibit 99.1 under Item 2.02, and the same information is also referenced under Item 7.01 for Regulation FD disclosure. The company states that this information is being furnished, not filed, so it is not subject to liability under Section 18 of the Exchange Act unless later specifically incorporated by reference into another filing.
Coya Therapeutics (COYA) priced an underwritten public offering. The company agreed to sell 4,181,818 shares of common stock, including 545,454 from the underwriter’s fully exercised option, at $5.50 per share. Gross proceeds are estimated at approximately $23.0 million before fees and expenses, with closing expected on or about October 27, 2025, subject to customary conditions.
The deal was conducted under an effective Form S-3, with Lucid Capital Markets as underwriter. Directors and executive officers entered lock-up agreements restricting sales through January 22, 2026. Allele Capital Partners, via Wilmington Capital Securities, acted as financial advisor; the company will pay $200,000 and issue warrants for 100,000 shares at a $5.50 exercise price under a private placement exemption.
Coya Therapeutics, Inc. reports receiving a $4.2 million milestone payment from its strategic partner Dr. Reddy’s Laboratories. The payment was triggered when the FDA accepted Coya’s Investigational New Drug application for a planned Phase 2 clinical study of COYA 302 in amyotrophic lateral sclerosis (ALS).
Coya is also entitled to an additional $4.2 million from Dr. Reddy’s Laboratories when the first patient is dosed in this Phase 2 ALS study, which is designed as a randomized, double-blind, placebo-controlled, multi-center trial with an open-label extension.
Coya Therapeutics, Inc. filed a current report to note that it issued a press release with information about its results of operations for the fiscal quarter ended June 30, 2025. The press release is furnished as Exhibit 99.1 and is not deemed filed for liability purposes under the Exchange Act.
Coya Therapeutics (NASDAQ:COYA) filed a Form 8-K reporting the results of its June 26, 2025 Annual Meeting of Stockholders.
- Directors re-elected: Howard Berman, Ph.D. (5,821,649 for), Arun Swaminathan, Ph.D. (6,324,520 for), and Ann Lee, Ph.D. (5,779,312 for); broker non-votes totaled 4,096,866 shares.
- Auditor ratified: Weaver & Tidwell, L.L.P. was approved as independent registered public accounting firm for FY 2025 with 10,355,085 votes for (98.9%), 68,851 against, and 340 abstentions.
No additional proposals were presented and the filing discloses no material changes to operations, strategy, or governance.