Coya Therapeutics, Inc. develops investigational biologics intended to enhance regulatory T-cell, or Treg, function in neurodegenerative disorders. Company news centers on COYA 302, including clinical and regulatory updates in amyotrophic lateral sclerosis and frontotemporal dementia, biomarker publications, and research on systemic inflammation, lipid peroxidation, axonal injury, and Treg dysfunction.
Coya updates also cover its Treg-focused therapeutic platforms, including Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy. Recurring business developments include collaboration activity with Dr. Reddy’s Laboratories, milestone-related revenue disclosures, operating results, stockholder communications, and board or governance changes.
Coya Therapeutics (COYA) reported a third-quarter net loss of $10.6 million and completed enrollment in its Phase 2/3 ALSTARS trial. The loss compared with $2.1 million a year earlier. Collaboration revenue fell to $234,134 from $3,564,254, while research and development expenses rose to $8,570,787 from $2,916,875.
ALSTARS enrolled 137 participants, including participants already in screening beyond the planned 120. Coya expects results from the 24-week placebo-controlled treatment phase in early Q2 2027 and plans an extension allowing participants completing 48 weeks to continue treatment. It also plans a Phase 2 frontotemporal dementia study in 2027.
Cash and cash equivalents were $35.8 million at September 30, 2026. Coya expects that balance to fund currently planned operations past the ALSTARS results and into the second half of 2027. Nine-month operating cash use increased to $20,819,631 from $9,732,174 a year earlier.
Coya Therapeutics (NASDAQ: COYA) will present its ALSTARS Trial biomarker stratification methodology at the 2026 Annual NEALS Meeting on October 28.
The ongoing Phase 2/3 trial evaluates COYA 302 for amyotrophic lateral sclerosis (ALS). Eligible participants’ baseline blood levels of neurofilament light chain (NfL), a marker of nerve-cell damage, were grouped into low, medium and high tiers to balance randomization across treatment arms. Coya believes this approach reduces differences in participants’ expected disease progression and may improve detection of treatment effects on the primary outcome, the Revised ALS Functional Rating Scale.
Coya Therapeutics (COYA) plans an open-label extension of its Phase 2/3 ALSTARS trial evaluating COYA 302 for amyotrophic lateral sclerosis (ALS). The company expects the extension to begin in November 2026, as the first cohort completes 48 weeks of treatment. Eligible participants completing that treatment period may continue receiving COYA 302, enabling collection of longer-term efficacy and safety data. Coya gives investigator and participant requests as the reason for the extension.
Coya expects to prioritize resources toward COYA 302 development in ALS and near-term ALSTARS milestones. The Phase 2 trial in frontotemporal dementia, previously anticipated in the second half of 2026, is now expected in 2027. Cash runway guidance remains unchanged: existing cash is expected to fund operations into the second half of 2027, beyond the anticipated ALSTARS topline data readout in early Q2.
Coya Therapeutics (COYA) will participate in a panel discussion at Chardan's 10th Annual Healthcare Conference on October 20 in New York.
The panel covers neurodegenerative and neuromuscular diseases and starts at 2:00 PM ET. President and Chief Medical Officer Fred Grossman will represent Coya, with Chardan analyst Keay Nakae moderating. Coya's management team will also be available for one-on-one meetings.
Coya Therapeutics (NASDAQ: COYA) has completed planned enrollment of 120 participants in its Phase 2/3 ALSTARS trial evaluating COYA 302 for ALS. Additional participants already in active screening may enroll if eligible. Coya anticipates topline data in early Q2 2027 from the 24-week double-blind treatment phase. The randomized, placebo-controlled trial evaluates a combination of proprietary low-dose IL-2 and CTLA-4 Ig as a potential treatment for amyotrophic lateral sclerosis.
COYA 302 has received FDA Fast Track designation for ALS, intended to facilitate development and expedite review. Under a December 2023 collaboration, Dr. Reddy’s Laboratories holds exclusive ALS commercialization rights globally except Japan, South America and Mexico. Coya is responsible for clinical development and seeking U.S. regulatory approval.
Coya Therapeutics (COYA) has enrolled the 100th participant in its ongoing Phase 2/3 ALSTARS trial of COYA 302 for amyotrophic lateral sclerosis (ALS), keeping the study on track for topline results in early Q2 2027.
The trial is evaluating COYA 302, a combination of proprietary low-dose IL-2 and CTLA-4 Ig designed to enhance T‑cell (Treg) function in patients with neurodegenerative disorders. Based on current screening and enrollment rates, the company expects to complete full enrollment of 120 participants in the coming weeks, which would support the planned early Q2 2027 topline data readout. Additional participants are continuing to roll over into the active extension arm of the study, and COYA 302 has received FDA Fast Track designation for the treatment of ALS.
Coya Therapeutics (COYA) reported publication of preclinical data on COYA 303, a combination of proprietary low-dose IL-2 (LD‑IL2) and a GLP‑1 receptor agonist (GLP‑1RA), in the International Journal of Molecular Sciences.
In a subacute low-dose LPS mouse model of peripheral and CNS inflammation, the combination therapy showed complementary immunomodulatory effects versus either component alone. Peripherally, COYA 303 significantly reduced pro‑inflammatory myeloid IL‑6 and TNF transcript expression and increased ARG1, while enhancing Treg‑associated IL‑2Ra (CD25), TGF‑b1 and CTLA‑4 transcripts. In cortical and hippocampal tissues, it significantly lowered IL‑6 and IL‑1b and increased CD163 and CD206, markers of anti‑inflammatory M2 macrophages, whereas monotherapies produced limited changes. Treatment began 24 hours after LPS administration, indicating effects after inflammatory induction had started. Coya believes these results support further evaluation of COYA 303 in Alzheimer’s disease and other complex neurodegenerative indications and plans to pursue non‑dilutive funding and potential partnerships.
Coya Therapeutics (NASDAQ: COYA) reported Q2 2026 results and a pipeline update focused on lead biologic COYA 302 for ALS and frontotemporal dementia (FTD). Enrollment in the Phase 2 ALSTARS ALS trial is proceeding as planned, with completion targeted in 2H 2026 and topline data expected in Q1 2027. The company plans to initiate a Phase 2 FTD study of COYA 302 in 2H 2026 and reported that the first ALSTARS cohort has entered the 24‑week blinded extension phase. COYA 302 also received FDA Fast Track Designation for ALS.
Coya ended June 30, 2026 with $43.2 million in cash and cash equivalents, which the company expects will fund operations past the ALSTARS topline readout and into 2H 2027. Q2 2026 collaboration revenue was $0.24 million. Research and development expenses rose to $5.0 million, while general and administrative expenses declined to $2.3 million. Net loss for the quarter was $6.6 million, or $0.28 per basic and diluted share, compared with a net loss of $6.1 million, or $0.36 per share, in Q2 2025.
Coya Therapeutics (NASDAQ: COYA) will present the ALSTARS Phase 2 trial design for Coya 302 at the ENCALS 2026 Meeting in Madrid, Spain, June 24–26, 2026.
The poster highlights a precision immunomodulatory approach targeting regulatory T cells and neuroinflammation in ALS, presented on June 24, 2026.
Coya Therapeutics (NASDAQ: COYA), a clinical-stage biotechnology company focused on Treg-targeted biologics for neurodegenerative disorders, will host a virtual webinar on June 24, 2026 at 4 p.m. ET / 1 p.m. PT.
The event, titled “Beyond the Hit: How Repetitive Head Trauma, Inflammation, and Neurodegenerative Disease Intersect”, will examine links between repetitive head trauma, chronic inflammation, and conditions such as CTE and ALS. NFL broadcaster and former Cincinnati Bengals player Solomon Wilcots will moderate. Speakers include ALS researcher Stanley H. Appel, M.D., Coya president and chief medical officer Fred Grossman, D.O., and sports agent and concussion-awareness advocate Leigh Steinberg. The live webinar will feature written Q&A, requires pre-registration, and a recording will be posted on Coya’s website.