Coya Therapeutics (COYA) Investor presentation summary

Investment highlights

• Pipeline centers on COYA 302, low-dose IL-2 plus CTLA4-Ig, for ALS, FTD and other neurodegenerative diseases; COYA 303, low-dose IL-2 plus GLP-1 RA, is being explored for Alzheimer's disease.

• Scientific rationale includes Nobel-recognized Treg biology and links between Treg dysfunction and ALS/FTD; Treg dysfunction is associated with immune activation and chronic inflammation.

• ALS and FTD are described as high-unmet-need orphan indications; estimated U.S. populations are ~33,000 for ALS and 50,000–60,000 for FTD.

Therapeutic approach

• Low-dose IL-2 is intended to expand Treg numbers and enhance suppressive function; CTLA4-Ig is intended to shift myeloid cells toward an anti-inflammatory phenotype.

• The combination is designed to rebalance immune homeostasis and reduce neuroinflammation, addressing complex, multifactorial disease biology.

• Low-dose IL-2 is used at ~50x lower doses than standard IL-2 dosing; CTLA4-Ig safety and efficacy are established across millions of patients in rheumatoid arthritis and other inflammatory and autoimmune conditions.

ALS

• ALSTARS Phase 2/3 enrollment completed in October 2026 with 137 participants; topline data are expected early Q2 2027, and open-label extension initiation was expected in November 2026.

• Primary endpoint is change in ALSFRS-R total score from baseline to Week 24 versus placebo; COYA 302 has Fast Track designation in ALS.

• In a 48-week investigator-initiated study of four mild-to-moderate ALS patients, three had stable or improved ALSFRS-R scores (+4, +3, stable); all completed treatment, with no deaths or serious adverse events.

• ALS is described as rapidly progressive, with ~1-point monthly ALSFRS-R decline and 20–30% mortality within two years of diagnosis; ~90% of cases are sporadic.

• Approved therapies were characterized as providing modest effects; RELYVRIO was withdrawn from the U.S. market in April 2024 after failure of the Phase 3 PHOENIX trial.