a Therapeutics(COYA) - 2025 Q4 - Annual Report

Financial Performance - Coya Therapeutics reported net losses of $21.2 million and $14.9 million for the years ended December 31, 2025, and 2024, respectively, with an accumulated deficit of $62.0 million as of December 31, 2025[20]. - The company expects to incur significant expenses and operating losses as it advances its product candidates through clinical trials and seeks regulatory approval[22]. - Coya's operations are primarily funded through the sale of securities, with plans to raise additional capital to support ongoing and future development[24]. Clinical Development - The company is conducting the ALSTARS Trial, a Phase 2 study for COYA 302 in ALS, with enrollment expected to complete in the second half of 2026[25]. - The FDA accepted the IND application for COYA 302 for both ALS and frontotemporal dementia (FTD), indicating progress in clinical development[27]. - COYA 302 is a biologic combination intended to enhance Treg function while depleting T effector function and activated macrophages[47]. - COYA 302 is also advancing for the treatment of FTD, with an IND accepted in January 2026[69]. - The anticipated developmental milestones include the acceptance of IND for COYA 302 in FTD in 1Q 2026 and the initiation of a Phase 2a study in 2H 2026[126]. Product Candidates - Coya plans to develop COYA 303, a new product candidate for inflammatory diseases, which has shown promising preclinical results in reducing pro-inflammatory responses[30]. - The company aims to leverage COYA 301 as a backbone for combination therapies targeting various neurodegenerative and autoimmune diseases[38]. - COYA 303, a new product candidate for inflammatory diseases, combines COYA 301 and a GLP-1 RA, showing significant immunomodulatory effects in preclinical studies[83]. - The Treg-derived exosome product candidate, COYA 201, is being developed with consistent batch-to-batch comparability and adequate long-term stability[117]. Clinical Study Results - Interim results from a proof of concept study for COYA 302 in FTD showed no serious adverse events and demonstrated enhanced Treg numbers and cognitive function stability[29]. - In a proof-of-concept study, ALS patients showed no decline or minimal decline in ALSFRS-R scores at 24 weeks (33.75 ±3.3) and 48 weeks (32 ±7.8) compared to baseline (33.5 ±5.9)[58]. - Treg suppressive function increased significantly during treatment, with values at 24 weeks (79.9±9.6) and 48 weeks (89.5±4.1) compared to baseline (62.1±8.1) (p<0.01)[61]. - The most common adverse event in the POC study was mild injection-site reactions, with no serious adverse events reported[67]. - The POC study in FTD showed no significant decline in cognitive function over 22 weeks, with MOCA scores remaining stable[77]. - The LD IL-2 q4wks treatment group showed a clinically meaningful improvement of 4.93 points in the ADAS-Cog14 score compared to placebo, indicating stabilization of cognitive function[95][101]. Regulatory Environment - Regulatory compliance is critical, with the FDA overseeing the approval process for biologics, requiring substantial time and financial resources for navigating preclinical and clinical trial requirements[137][140]. - The FDA must make a decision on accepting a BLA for filing within 60 days of receipt, which could include a refusal to file[152]. - The FDA targets ten months for the initial review of a new molecular entity NDA and six months for priority review[152]. - The company is subject to significant regulatory scrutiny, including compliance with FDA requirements and potential legal actions for non-compliance, which can lead to severe penalties[174]. - The company must comply with various federal and state laws targeting fraud and abuse, which could affect its sales and marketing strategies[189]. Market and Competitive Landscape - The competitive landscape includes various companies developing similar therapies for ALS and Treg-based cellular therapeutics, with some having greater financial resources and market experience[130][132]. - The company faces uncertainty regarding coverage and reimbursement for its product candidates, which can significantly impact sales in the U.S. market[177]. - The Inflation Reduction Act of 2022 mandates price negotiations for certain drugs under Medicare, with new prices for ten drugs starting in 2026 and another fifteen in 2027[186]. Intellectual Property and Exclusivity - The company licensed exclusive worldwide rights to a proprietary Exosome Engineering Technology from Carnegie Mellon University in September 2023, aimed at applications in neurodegeneration, autoimmune diseases, and oncology[122]. - The company may apply for patent term restoration of up to five years under the Hatch-Waxman Amendments, but cannot extend beyond a total of 14 years from the product's approval date[211]. - Recent litigation has created uncertainty regarding the ultimate effect, implementation, and meaning of the BPCIA exclusivity provisions[216].