Coya Therapeutics, Inc. Stock Price, News & Analysis

Coya Therapeutics (NASDAQ: COYA) priced an underwritten public offering of 3,636,364 shares of common stock at $5.50 per share, with gross proceeds expected to be approximately $20.0 million. The company granted the underwriter a 30-day option to purchase up to 545,454 additional shares at the offering price, subject to underwriting discounts and commissions.

The offering is expected to close on or about October 27, 2025, subject to customary closing conditions. Net proceeds are intended for working capital and general corporate purposes, including funding Coya's clinical development plan. The shares are offered under a Form S-3 shelf registration declared effective August 19, 2025.

Coya Therapeutics (NASDAQ: COYA) announced a proposed underwritten public offering of common stock on October 23, 2025.

The offering may include a 30-day underwriter option to purchase up to an additional 15% of the shares at the offering price, less discounts and commissions. Proceeds are intended for working capital and clinical development. Lucid Capital Markets is sole book-running manager.

The offering is being made under a shelf registration statement on Form S-3 (File No. 333-289511) declared effective by the SEC on August 19, 2025; final terms will be disclosed in a prospectus supplement and are subject to market and other conditions.

Coya Therapeutics (NASDAQ: COYA) congratulated scientific advisor Dr. Shimon Sakaguchi on receiving the 2025 Nobel Prize in Physiology or Medicine for the discovery of regulatory T cells (Tregs). The company noted Dr. Sakaguchi’s long-standing advisory role guiding Coya’s strategy to harness and enhance Treg biology for therapies targeting immune dysfunction. Coya emphasized the Nobel recognition as validation of Treg science and said it remains committed to advancing therapies inspired by that discovery.

Coya Therapeutics (NASDAQ:COYA) has completed patient enrollment in an investigator-initiated, open-label study evaluating a combination treatment of low-dose IL-2 and CTLA4-Ig in patients with mild to moderate Frontotemporal Dementia (FTD). The study, conducted at Houston Methodist Neurological Institute, has successfully enrolled all 9 planned patients.

Following positive interim results from 5 patients announced in April 2025, the trial added 4 more patients. The treatment involves subcutaneous CTLA4-Ig administration followed by a 5-day course of low-dose IL-2 every four weeks, for 22 weeks of dosing and follow-up. The study has reported no serious adverse events or safety-related discontinuations and is expected to complete in Q4 2025 with topline results to follow.

Coya Therapeutics (NASDAQ:COYA) has launched the ALSTARS Trial, a Phase 2 clinical study evaluating COYA 302 for treating Amyotrophic Lateral Sclerosis (ALS). The trial is designed as a randomized, multi-center, double-blind, placebo-controlled study spanning 24 weeks.

Key trial details include:

• Enrollment of 120 ALS participants across approximately 25 centers in the US and Canada
• Two different COYA 302 dosing groups plus placebo
• Additional 24-week blinded extension period where all participants receive COYA 302

The study focuses on COYA 302's mechanism of enhancing regulatory T cell function in patients with neurodegenerative disorders.

Coya Therapeutics (NASDAQ:COYA) reported promising preclinical results for COYA 303, its investigational combination therapy of LD-IL-2 and GLP-1RA, in a mouse model of systemic and neuroinflammation. The study demonstrated significant anti-inflammatory effects both systemically and in the central nervous system.

The first cohort results showed that COYA 303 effectively reduced pro-inflammatory myeloid cells, increased anti-inflammatory immune cells, and attenuated neuroinflammation in the brain. The therapy showed particular promise in enhancing regulatory T cell (Treg) function and survival in inflammatory environments, supporting its potential application in treating Alzheimer's Disease and other neurodegenerative conditions.

The company is currently conducting additional cohort studies to evaluate modified treatment protocols, with plans to present complete findings in a peer-reviewed forum.

Coya Therapeutics (NASDAQ: COYA) announced that its Phase 2 clinical trial for COYA 302 in ALS patients has been accepted as a NEALS-Affiliated Trial by the NEALS Consortium, the world's largest ALS research network. The trial, following FDA's recent IND acceptance, is scheduled to begin in Q4 2025.

The study will be presented during the NEALS Educational Webinar on September 29, 2025, by Dr. James Berry from Mass General Hospital. As a NEALS-affiliated study, COYA 302's trial will receive broad support across NEALS' institutional and community networks, enhancing operational execution and clinical impact.

Coya Therapeutics (NASDAQ: COYA), a clinical-stage biotech company specializing in regulatory T cell (Treg) function enhancement for neurodegenerative disorders, has announced its participation in two major investor conferences in September 2025.

CEO Arun Swaminathan will present at the H.C. Wainwright Global Investment Conference on September 10 at 10 am ET at the Lotte New York Palace Hotel. The company will also attend the Lake Street Capital Markets Best Ideas Growth Conference on September 11 at The Yale Club of New York City. Management will be available for one-on-one meetings at both events.

Coya Therapeutics (NASDAQ:COYA) has received FDA acceptance of its Investigational New Drug (IND) application for COYA 302, a proprietary immunomodulatory biologic combination therapy for treating Amyotrophic Lateral Sclerosis (ALS). The acceptance enables the company to proceed with a Phase 2 multicenter, double-blind, placebo-controlled clinical study to evaluate the treatment's efficacy and safety.

The milestone triggers a $4.2 million payment to Coya from its partner Dr. Reddy's Laboratories (DRL). The development represents a significant step in Coya's partnership with DRL to advance potential treatments for ALS patients.