Coya Therapeutics (COYA) 7th Annual Evercore ISI HealthCONx Healthcare Conference summary

Company evolution and scientific focus

• Founded 4–5 years ago, initially as a cell therapy company, now focused on biologics to enhance regulatory T-cells (Tregs) for neurodegenerative diseases.

• Proprietary low-dose Interleukin-2 (IL-2) and CTLA-4 Ig combination (Coya 302) targets neuroinflammation by boosting Treg function and durability.

• Shifted from autologous cell therapy to biologics, reducing costs and improving scalability.

• Approach is unique due to recent recognition of Tregs' central role in neurodegeneration.

Clinical development and trial design

• Lead program Coya 302 is advancing in ALS, with IND and Phase 2 trial expected to start in Q2 next year after additional preclinical toxicology work.

• Phase 2 ALS trial will be double-blind, randomized, with two dose arms versus placebo, and a six-month endpoint, followed by open-label extension.

• Excludes fast progressors based on ALSFRS decline rate; includes both genetic and sporadic ALS patients.

• Small investigator-initiated ALS study showed halted disease progression over six months and minimal decline over one year.

Safety, biomarkers, and mechanistic insights

• Safety profile is favorable, with only minor injection site reactions observed in ALS and Alzheimer's studies.

• Low-dose IL-2 improves Treg function and cognitive outcomes in Alzheimer's; higher doses may reduce efficacy.

• Biomarker data suggest both NfL and oxidative stress markers are predictive of disease progression; positive effects on NfL seen in Alzheimer's.

• Combination therapy hypothesized to maintain Treg health and durability by modulating the inflammatory environment.