Coya Therapeutics (COYA) Oppenheimer 35th Annual Healthcare Life Sciences Conference (Virtual) 2025 summary

Strategic focus and pipeline overview

• Focus on innovative therapies for neurodegenerative diseases by targeting regulatory T cells to reduce neuroinflammation.

• Pipeline includes COYA 301 (recombinant IL-2), COYA 302 (IL-2 + CTLA4), and COYA 303 (IL-2 + GLP-1 agonist).

• COYA 302 is being advanced in ALS and frontotemporal dementia, with plans for Alzheimer's and Parkinson's indications.

• Strategic partnership with Dr. Reddy's Laboratories for COYA 302 in ALS, covering most global markets and up to $700 million in milestone payments.

• Cash position of $40 million as of October 31, 2023, supporting operations into 2026.

Clinical data and upcoming milestones

• Proof-of-concept trials showed COYA 302 halted ALS progression at six months and stabilized cognitive decline in Alzheimer's.

• Additional data from Alzheimer's trials showed positive impact on inflammatory markers and cytokines.

• Phase 2B ALS trial to initiate later in 2024, with IND submission planned for Q2 2025.

• Top-line results from frontotemporal dementia trial expected early in the second half of 2025, with IND submission by year-end.

• Data on COYA 301 and GLP-1 synergy to be published in the coming months.

Scientific rationale and trial design

• Approach centers on restoring Treg function to address neuroinflammation, a key driver in neurodegenerative diseases.

• COYA 302 combines IL-2 and CTLA4 to increase Treg durability and suppressive function, providing synergistic neuroprotection.

• ALS phase 2B trial will enroll 120 patients, placebo-controlled, with a six-month ALSFRS endpoint and crossover design.

• All ALS genetic subtypes included; trial designed to balance standard-of-care therapies across arms.

• NfL and other biomarkers will be key secondary endpoints, with potential for accelerated approval discussions.