Coya Therapeutics, Inc. filings document regulatory and financial disclosures for a clinical-stage biotechnology company developing Treg-enhancing biologics for neurodegenerative disorders. The record includes Form 8-K reports on operating results, corporate updates, clinical and regulatory disclosures for COYA 302, and study results involving low-dose IL-2 and CTLA4-Ig approaches in frontotemporal dementia.
Filings also cover material agreements and milestone payments under the company’s development and license relationship with Dr. Reddy’s Laboratories, board and executive-chairman changes, compensation and separation arrangements, and capital-structure disclosure for Coya’s Nasdaq-listed common stock. These documents provide formal disclosure of governance matters, collaboration economics, clinical-program status, and other material events.
Coya Therapeutics, Inc. expects to begin an open-label extension of its Phase 2/3 ALSTARS trial evaluating COYA 302 for ALS in November 2026, as the first cohort completes the 48-week treatment period. Participants who complete that period may continue receiving COYA 302, allowing collection of longer-term efficacy and safety data. ALSTARS includes a 24-week double-blind treatment phase and a 24-week blinded active-treatment extension.
Coya is prioritizing resources toward ongoing ALS development and timely ALSTARS milestones. Its planned Phase 2 trial of COYA 302 for FTD, previously anticipated in the second half of 2026, is now expected in 2027. Cash runway guidance remains unchanged, with existing cash resources expected to fund operations into the second half of 2027, beyond the anticipated ALSTARS topline data readout.
Coya Therapeutics, Inc. announced full enrollment of the planned 120 patients in its Phase 2/3 ALSTARS Trial evaluating COYA 302, a combination of proprietary low-dose IL-2 and CTLA-4 Ig, for ALS. Participants already in active screening may enroll if deemed eligible. Approximately 120 subjects will be randomized 1:1:1 to one of two pre-specified COYA 302 dosing regimens or placebo for a 24-week double-blind treatment phase. Patients completing that phase enter a 24-week blinded active-treatment extension; placebo recipients are re-randomized to one of the two COYA 302 regimens, providing up to 48 weeks of COYA 302 data. Topline data from the double-blind phase are anticipated in early Q2 2027.
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., a clinical-stage biotech focused on regulatory T cell–based therapies, reported continued operating losses while maintaining a solid cash position for the quarter ended June 30, 2026. Cash and cash equivalents were $43.2 million, with total assets of $47.3 million and total liabilities of $4.0 million, leaving stockholders’ equity at $43.3 million. Management expects this cash to fund operations into the second half of 2027.
For the three months ended June 30, 2026, collaboration revenue was $0.24 million, entirely from R&D services under the Dr. Reddy’s COYA 302 alliance. Operating expenses reached $7.3 million, driven by $5.0 million in research and development and $2.3 million in general and administrative costs. Net loss for the quarter was $6.6 million (or $0.28 per share), compared with $6.1 million a year earlier.
For the six‑month period, collaboration revenue totaled $0.49 million, while research and development and general and administrative expenses were $9.1 million and $6.0 million, respectively. Net loss for the six months was $13.8 million. The company added equity capital via a January 2026 private placement and put a $30.0 million at‑the‑market stock program in place. COYA 302, its lead ALS candidate, is in a Phase 2 trial and received FDA Fast Track Designation on May 11, 2026.
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. is the subject of an amended Schedule 13G filing by investment entities associated with Orin Hirschman, including AIGH Capital Management LLC and AIGH Investment Partners LLC. The reporting persons disclose beneficial ownership of 764,679 shares of common stock, representing 3.3% of the class, with sole voting and dispositive power over these shares and no shared power. The filing notes that this represents ownership of 5 percent or less of Coya’s outstanding common stock.
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 is asking stockholders to vote at a virtual annual meeting on June 25, 2026. Investors are being asked to elect two Class I directors, Wilbur Ross and Dieter Weinand, to serve until the 2029 meeting, and to ratify Weaver and Tidwell, L.L.P. as independent auditor for 2026.
The proxy details board structure, committee membership and independence, executive and director compensation, and the company’s 2021 equity incentive plan. It also outlines ownership levels, with 23,457,183 common shares outstanding as of May 1, 2026, and explains how stockholders can attend and vote electronically.