Coya Therapeutics (COYA) investor relations material

Investment highlights

• Pipeline centers on COYA 302, low-dose IL-2 plus CTLA4-Ig, across ALS, FTD, Alzheimer’s disease and Parkinson’s disease; COYA 303 combines low-dose IL-2 with a GLP-1 receptor agonist for Alzheimer’s disease.

• COYA 302 ALS ALSTARS Phase 2/3 enrollment completed in October 2026; open-label extension expected to start in November and topline data are expected early Q2 2027.

• Investigator-initiated studies reported ALSFRS-R stabilization over 48 weeks and cognitive stability over 22 weeks in FTD; study sizes were 4 and 9 patients, respectively.

• Scientific advisory board member Shimon Sakaguchi shared the 2025 Nobel Prize in Physiology or Medicine for work on Treg biology.

• Dr. Reddy’s collaboration includes potential milestones of up to ~$700M and mid-teen royalties; $43.2M cash at June 30, 2026, was projected to fund operations into H2 2027, beyond the expected ALS readout.

Therapeutic rationale

• Treg dysfunction is linked to immune activation and chronic inflammation; low-dose IL-2 is intended to expand Tregs and enhance suppressive function.

• CTLA4-Ig is intended to shift myeloid cells toward an anti-inflammatory phenotype; the combination aims to rebalance immune homeostasis and protect against neurodegeneration.

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

• The presentation cites Nobel-recognized Treg biology, an association between Treg dysfunction and ALS/FTD, and independent scientific support for the ALS approach.

COYA 302 in ALS

• ALS is rapidly progressive; 20–30% of patients die within two years of diagnosis, ~90% of cases are sporadic, and natural-history data show ~1 point/month ALSFRS-R decline.

• Approved therapies were described as slowing but not stopping progression; RELYVRIO was withdrawn from the U.S. market in April 2024 after the Phase 3 PHOENIX trial failed.

• In a 48-week investigator-initiated study of 4 mild-to-moderate ALS patients, 3 were stable or improved on ALSFRS-R (+4, +3, stable); treatment was well tolerated, with no deaths or serious adverse events.

• ALSTARS is a randomized, double-blind, placebo-controlled Phase 2/3 study, fully enrolled at 120 patients; its primary endpoint is ALSFRS-R change from baseline to Week 24 versus placebo, and COYA 302 has Fast Track designation.

• Dr. Reddy’s holds an exclusive license to commercialize COYA 302 for ALS in the U.S., Canada, EU and UK if approved; terms include up to $40M in development/regulatory milestones, ~$677M in potential sales milestones and low-to-mid-teen net-sales royalties.