Core Viewpoint - Coya Therapeutics, Inc. has announced its intention to conduct an underwritten public offering of common stock to raise funds for working capital and clinical development [1][2]. Company Overview - Coya Therapeutics is a clinical-stage biotechnology company based in Houston, TX, focused on developing biologics that enhance regulatory T cell (Treg) function to address neurodegenerative disorders [5]. - The company is developing proprietary treatments targeting systemic inflammation and neuroinflammation, with a focus on restoring the anti-inflammatory functions of Tregs [5][6]. Proposed Public Offering - The company plans to offer shares of its common stock and may grant underwriters a 30-day option to purchase an additional 15% of the shares at the public offering price [1]. - The net proceeds from the offering will be used for working capital and general corporate purposes, including funding its clinical development plan [2]. - The offering is subject to market conditions, and there is no assurance regarding its completion or the actual size and terms [1][2]. Clinical Development - Coya's investigational product candidate pipeline includes various therapeutic modalities aimed at enhancing Treg functions, such as Treg-enhancing biologics and autologous Treg cell therapy [6]. - The company is currently conducting the ALSTARS Trial, a Phase 2 study evaluating the efficacy and safety of its investigational product COYA 302 for the treatment of ALS [8].

Core Insights - Coya Therapeutics is positioned for a transformative year in 2025 with FDA clearance of its first IND and the initiation of a pivotal ALS trial [3][6] - The company is focused on developing Treg-modulating therapies to address ALS and other neurodegenerative diseases [4][6] Company Overview - Coya Therapeutics, Inc. is a clinical-stage biotechnology company headquartered in Houston, TX, specializing in treatments that target systemic inflammation and neuroinflammation through regulatory T cells (Tregs) [4][6] - The company’s pipeline includes Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy [5][6] Recent Developments - The FDA accepted the IND application for COYA 302 in ALS, allowing the start of a Phase 2 clinical trial [6] - Strategic partnerships, notably with Dr. Reddy's Laboratories, provide financial support and expertise in manufacturing and commercialization [6] Future Plans - Coya plans to expand its pipeline beyond ALS, with an IND filing for frontotemporal dementia expected in late 2025 [6] - Key upcoming milestones include the initiation of the ALS trial, data readouts for frontotemporal dementia, and new preclinical results across multiple programs [6]

Corporate Update - Coya Therapeutics, Inc. is focused on developing biologics that enhance regulatory T cell function in neurodegenerative disorders [1] - The company is awaiting a decision from the FDA on its IND application for COYA 302 in ALS, expected by the end of August 2025 [4] - Coya plans to submit an IND for Frontotemporal Dementia (FTD) by the end of 2025 [4] Financial Results - As of June 30, 2025, Coya had cash and cash equivalents of $29.8 million, down from $38.3 million at the end of 2024 [5][18] - Collaboration revenues for the quarter were $0.2 million, a decrease of approximately $3.3 million compared to $3.4 million in the same quarter of 2024 [5] - Research and development expenses were $3.7 million, down from $4.6 million in the previous year, primarily due to a decrease in preclinical expenses [6] - General and administrative expenses increased to $2.9 million from $2.1 million year-over-year, attributed to higher stock-based compensation and professional services [8] - The net loss for the quarter was $6.1 million, compared to a net loss of $2.9 million for the same period in 2024 [9][20] Upcoming Catalysts - The company is preparing to initiate a controlled Phase 2 clinical trial in ALS pending FDA clearance for COYA 302 [4] - Coya expects to receive milestone payments of $8.4 million from Dr. Reddy's Laboratories upon IND acceptance and first patient dosing of COYA 302 in ALS [7] - Additional nonclinical data to support the start of the COYA 302 Phase 2 trial was submitted to the FDA on June 30, 2025 [7] Product Pipeline - COYA 302 is an investigational biologic combination therapy aimed at enhancing the anti-inflammatory function of regulatory T cells and is being developed for ALS [10][11] - COYA 303 is another investigational product designed for subcutaneous administration, exhibiting a dual immunomodulatory mechanism of action in preclinical studies [12] Research Developments - Recent scientific research published in Frontiers of Immunology linked inflammation and oxidative stress to the progression of Parkinson's Disease [7] - Coya reported new proteomics data from a completed Phase 2 study of low-dose interleukin-2 in Alzheimer's disease [7]