Coya Therapeutics Receives Health Canada Approval for COYA 302 Clinical Trial
Coya Therapeutics announced that Health Canada has accepted, without objection, the clinical trial application for COYA 302 for the treatment of amyotrophic lateral sclerosis. The CTA acceptance by Health Canada allows for activation of clinical sites in Canada, enhancing patient recruitment alongside the U.S. clinical sites.
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- Funding Size: Coya Therapeutics announced the sale of approximately 2.52 million shares at $4.40 per share, raising about $11.1 million, which will provide essential capital to accelerate the commercial readiness of its COYA 302 program.
- Investor Background: In this financing round, Dr. Reddy’s Laboratories invested $10 million through a subsidiary, while the company's largest institutional shareholder, Greenlight Capital, contributed $1.1 million, reflecting strong market confidence and support for Coya.
- Use of Proceeds: Coya plans to utilize the funds raised to expedite technology transfer and scale-up manufacturing for low-dose IL-2, thereby enhancing its competitive position in the market as it prepares for the commercialization of COYA 302.
- Transaction Timeline: The private placement is expected to close on or about January 30, 2026, subject to customary conditions, which ensures future liquidity and project advancement for the company.
- Funding Amount: Coya Therapeutics has secured approximately $11.1 million through a private placement of 2,522,727 shares at $4.40 each, reflecting strong market confidence in its biologics development.
- Key Investors: The primary investors include Dr. Reddy’s Laboratories, contributing $10 million, and Greenlight Capital with $1.1 million, indicating a positive outlook from institutional investors regarding Coya's future prospects.
- Use of Proceeds: The company intends to utilize the proceeds to accelerate technology transfer and scale-up manufacturing for low-dose IL-2, supporting the commercial readiness of COYA 302, thereby enhancing its competitive position in the neurodegenerative disease market.
- Compliance Commitment: Coya has committed to filing a registration statement with the SEC within 45 days post-closing, ensuring the legal resale of the securities, which will bolster investor confidence and facilitate future capital operations.

- FDA Approval: Coya Therapeutics announced that its IND for COYA 302 to treat frontotemporal dementia has been accepted by the FDA, marking a significant advancement in the treatment of neurodegenerative diseases and aiming to address the urgent medical needs of approximately 60,000 patients.
- Clinical Need: Frontotemporal dementia is the most common form of dementia in individuals under 65, with an average onset age of 58 and a survival time of only 7.5 years, making Coya's new therapy potentially transformative in improving patient quality of life and slowing disease progression.
- Scientific Rationale: COYA 302 employs a dual immunomodulatory mechanism designed to enhance the anti-inflammatory function of regulatory T cells, which Coya believes will provide a new treatment option for frontotemporal dementia patients, filling a significant gap in the current market with no effective therapies available.
- Clinical Trial Plans: Coya expects to announce topline results from an open-label study evaluating low-dose IL-2 and CTLA4-Ig in patients with mild-to-moderate frontotemporal dementia in the coming weeks, further validating its efficacy and safety profile.

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Public Offering Announcement: Coya Therapeutics has priced an underwritten public offering of 3,636,364 shares of common stock at $5.50 per share, aiming to raise approximately $20 million for working capital and clinical development.
Underwriter and Closing Details: Lucid Capital Markets is the sole book-running manager for the offering, which is expected to close around October 27, 2025, pending customary closing conditions.
Company Overview: Coya Therapeutics, based in Houston, focuses on developing biologics to enhance regulatory T cell function for treating neurodegenerative disorders, with a pipeline that includes Treg-enhancing biologics and cell therapies.
Investigational Product COYA 302: COYA 302 is a proprietary biologic therapy aimed at treating ALS by enhancing Treg function and suppressing inflammation, currently being evaluated in a Phase 2 clinical trial.
Public Offering Details: Coya Therapeutics has announced a public offering of 3,636,364 shares priced at $5.50 each, aiming to raise approximately $20 million, with a potential additional 545,454 shares available to the underwriter.
Use of Proceeds: The company plans to utilize the net proceeds from the offering for working capital and general corporate purposes, including funding its clinical development plan.
Closing Timeline: The offering is expected to close around October 27, 2025, subject to standard closing conditions.
Market Reaction: Following the announcement, Coya Therapeutics' stock saw a premarket decline of 12.7%, trading at $6.09.








