Coya Therapeutics (NasdaqCM:COYA) FY Conference Transcript

Summary of Coya Therapeutics FY Conference Call (December 02, 2025) Company Overview - Company: Coya Therapeutics (NasdaqCM: COYA) - Focus: Development of therapies for neurodegenerative diseases, particularly through Treg (regulatory T cells) biology Key Accomplishments in 2025 - Progress in lead asset entering clinical trials, potentially moving towards registration trials [3][9] - Promising interim data from an investigator-initiated trial in frontotemporal dementia [9] - Positive preclinical data on the combination of GLP-1s with proprietary low-dose interleukin-2 (COYA 301) [9] - Recognition of scientific contributions, including a Nobel Prize awarded to a scientific advisory board member [9] Scientific Approach and Platform - Focus: Addressing neurodegenerative diseases by restoring Treg numbers and functions to reduce inflammation [10][11] - Three Pillars of Confidence: 1. Scientific Basis: Emphasis on Treg functionality to halt disease progression [11] 2. Combination Biologics: Utilizing a combination of low-dose interleukin-2 and CTLA-4 to enhance Treg efficacy [12] 3. Consistent Results: Positive outcomes observed across multiple investigator-initiated trials in ALS, FTD, and Alzheimer's [12] Clinical Trials and Regulatory Strategy - Lead Program: COYA 302 targeting ALS, currently in a randomized double-blind placebo-controlled trial with 120 patients [15] - Primary Endpoint: ALSFRS score at six months, with secondary endpoints including neurofilament light as a biomarker [15][19] - Regulatory Environment: FDA prioritizing ALS and FTD due to limited treatment options; Coya is optimistic about regulatory success based on preclinical and trial data [21][22] Future Indications and Prioritization - Next priority is frontotemporal dementia, with plans to submit an IND for a Phase 2A study in early 2026 [25] - Larger indications like Alzheimer's and Parkinson's are capital-intensive; Coya is seeking partnerships or grants to advance these programs [27] Financial Overview - Partnership with Dr. Reddy's: Total deal value of approximately $700 million, with milestone payments already received and future payments tied to patient dosing and product approval [32][33] - Cash Position: Approximately $28 million reported as of September 30, with an additional $23 million raised in late October [34] Key Objectives for 2026 - Focus on advancing the ALS trial, initiating the FTD trial, and progressing the GLP-1 COYA 303 program [35]