Summary of Coya Therapeutics FY Conference Call Company Overview - **Company**: Coya Therapeutics (NasdaqCM: COYA) - **Focus**: Development of transformative therapies for patients suffering from neurodegenerative diseases such as ALS, frontotemporal dementia, Alzheimer's, and Parkinson's [2][3] Core Points and Arguments - **Vision and Mission**: Coya aims to make neurodegenerative diseases manageable, shifting the narrative from the disease to the patients' lives [3] - **Scientific Approach**: The company believes that neurodegenerative diseases are primarily neuroinflammatory and that addressing neuroinflammation can halt disease progression [5][6] - **Lead Program**: COIA-302, a combination of low-dose interleukin-2 and CTLA-4, is set to enter a pivotal Phase 2b study involving 120 ALS patients, with the first patient expected to be dosed in Q4 2025 [8][24] - **Clinical Trial Support**: Coya has partnered with the NILS Foundation, the largest ALS consortium, to facilitate faster recruitment for the trial [9] Clinical Data and Outcomes - **Current ALS Treatment Landscape**: Existing therapies show minimal efficacy, with patients declining by approximately 6 points in 6 months on the ALSFRS scale [14] - **Initial Study Results**: In a small investigator-initiated study, Coya observed stabilization or improvement in ALSFRS scores, contrasting with expected declines [16][17] - **Mechanistic Insights**: The combination therapy has shown to maintain Treg function and numbers, which are crucial for managing neuroinflammation [12][18] Future Plans and Partnerships - **Regulatory Pathway**: The primary endpoint for the Phase 2b trial is set for 6 months, with plans to approach the FDA for a BLA filing based on the data [23] - **Commercialization Partnership**: Coya has partnered with Dr. Reddy's Laboratories for the commercialization of COIA-302, which will alleviate some financial burdens associated with bringing the product to market [24][26] - **Funding and Cash Flow**: A $700 million partnership with Dr. Reddy's provides non-dilutive cash flow, enhancing Coya's financial position [26] Additional Indications - **Frontotemporal Dementia (FTD)**: Coya plans to file an IND for FTD this year, with a small randomized study expected to start in 2026, supported by a $5 million investment from the Alzheimer's Drug Discovery Foundation [29] - **COIA-303 Development**: A new product combining COIA-301 with GLP-1 weight loss drugs shows promise in reducing neuroinflammatory markers, with potential applications in Alzheimer's disease [30][31] Key Metrics and Milestones - **Upcoming Milestones**: - Dosing of the first ALS patient in 2025, triggering a $4.2 million payment from Dr. Reddy's [33] - Filing for FTD IND and additional data from ongoing trials expected by the end of 2025 [33] Conclusion - Coya Therapeutics is positioned to make significant advancements in the treatment of neurodegenerative diseases, with a strong scientific foundation, promising early clinical data, and strategic partnerships that enhance its operational and financial capabilities [34]