Coya Therapeutics (COYA) H.C. Wainwright 27th Annual Global Investment Conference summary

Vision and scientific approach

• Focused on transforming neurodegenerative diseases like ALS and FTD into manageable conditions by targeting neuroinflammation through regulatory T cell (Treg) modulation.

• Belief that increasing and sustaining Treg function can halt disease progression, supported by both literature and internal clinical trials.

• Lead program, Coya 302, combines low-dose interleukin-2 with CTLA-4 to address both adaptive and innate immune systems.

Clinical development and trial data

• Phase IIB pivotal study in ALS to begin dosing in Q4, following recent FDA approval; primary endpoint is ALS-FRS at six months.

• Small investigator-initiated study showed stabilization or improvement in ALS-FRS scores over 48 weeks, with rapid decline resuming after therapy cessation.

• Biomarker data aligns with clinical outcomes, showing increased Treg numbers and function, and positive shifts in oxidative stress markers.

• Similar stabilization of cognitive decline observed in FTD patients, with plans to file IND for FTD in 2024 and initiate a randomized trial in 2026.

Strategic partnerships and financial outlook

• $700 million partnership with Dr. Reddy's Laboratories provides non-dilutive funding and commercial support for ALS indication.

• $4.2 million milestone payments received and expected upon first patient dosing; Dr. Reddy's to handle commercialization in major markets.

• Retained rights for other indications and strong collaboration with Houston Methodist for basic science research.

• Alzheimer's Drug Discovery Foundation invested $5 million to support FTD trial.