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]