Cognition Therapeutics (CGTX) 25th Annual Needham Virtual Healthcare Conference summary

Key program updates and strategic direction

• Preparing to enter Phase III for zervimesine, a once-daily neurodegenerative drug, with a focus on DLB psychosis as the next planned study.

• Strong Phase II data in DLB psychosis, with over 450 patients treated and a modest safety profile observed.

• Patent protection extends to 2040 with potential for further claims; commercialization plans are progressing.

• Expanded access program initiated due to patient and caregiver demand, funded externally to allow continued drug access.

• Current cash position of $37 million, with $36 million in grant funding dedicated to the START trial, supporting operations through June 2027.

Clinical trial results and regulatory feedback

• SHIMMER trial in DLB showed consistent slowing of disease progression across behavioral, cognitive, and motor domains, with significant effects on hallucinations and delusions.

• Caregiver distress was notably reduced in treated patients, aligning with observed symptom stabilization.

• SHINE trial in Alzheimer's disease demonstrated a 38% slower cognitive decline in patients with lower p-tau217, comparable to leading antibody therapies.

• Safety profile across studies remains favorable, with only mild, reversible liver enzyme elevations noted.

• START trial in early Alzheimer's is fully enrolled (545 patients), with 15-20% on background lecanemab or donanemab, and primary results expected in Q3 2027.

Forward-looking plans and trial design

• Regulatory discussions led to a focus on psychosis in DLB for Phase III, as this allows for a smaller, faster, and more cost-effective trial.

• Secondary endpoints in future trials will include motor and cognitive function, with statistical protection for potential label expansion.

• The 100 mg dose will be advanced in pivotal trials due to indistinguishable efficacy from 300 mg and a better safety profile.

• Future Alzheimer's trials will stratify patients by p-tau217 levels, based on insights from SHINE and external studies.

• DLB Phase III enrollment expected to begin in Q1 2027, with Alzheimer's START trial results anticipated in Q3 2027, potentially yielding two major readouts in a short timeframe.