Cognition Therapeutics (CGTX) Corporate presentation summary

Clinical development and therapeutic focus

• Zervimesine is an oral, once-daily small molecule targeting neuropsychiatric symptoms in dementia with Lewy bodies (DLB) and Alzheimer's disease (AD), advancing toward Phase 3 trials by March 2026.

• Demonstrated robust efficacy in Phase 2 studies, including 102% slowing of psychotic symptom progression in DLB and up to 95% slowing of cognitive decline in AD patients with lower p-tau217.

• Well-tolerated safety profile across over 450 treated participants, with modest side effects suitable for aging populations.

• Fast Track designation granted for Alzheimer's disease; robust intellectual property protection extends through 2040.

Regulatory and clinical strategy

• Completed FDA meetings for both DLB and AD programs, aligning on trial design, endpoints, and enrichment strategies for Phase 3.

• Next regulatory steps include a new IND and transition to the FDA Division of Psychiatry, with a key meeting scheduled for mid-2026.

• Open-label extension studies and expanded access programs are in place to ensure continued patient access and long-term safety data.

Disease impact and patient outcomes

• DLB psychosis represents a significant unmet need, with most patients experiencing psychotic symptoms that increase healthcare costs and institutionalization.

• Zervimesine stabilized psychotic and behavioral symptoms, with up to 114% slowing in caregiver distress and significant improvements in patient function and cognition.

• Patient and caregiver testimonials highlight meaningful improvements in daily living and communication.