Cognition Therapeutics(CGTX) - 2025 Q4 - Annual Results

Funding and Financials - Over $170 million in grants from NIH and others funded development through Phase 2[6] - The company has a cash runway through Q2 2027, with cash and equivalents totaling $37 million as of December 31, 2025[63] - The company has secured approximately $171 million in grant funding for zervimesine studies, with $36 million remaining[63] Clinical Efficacy - Zervimesine treatment stabilized psychotic symptoms in Phase 2, showing a 102% slowing of symptoms compared to placebo[7] - Phase 2 studies demonstrated efficacy across cognitive measures, particularly robust responses in participants with lower p-tau217 levels[14] - The NPI-4 analysis indicated a 102% slowing of psychotic symptoms in Zervimesine-treated participants relative to placebo[34] - Zervimesine demonstrated a 95% slowing of cognitive decline in lower p-tau217 participants in the SHINE study[40] - Participants with below median p-tau217 experienced a profound treatment effect, showing a 95% slowing in cognitive decline[54] Safety and Tolerability - Zervimesine has a favorable safety profile, well tolerated in over 450 individuals treated to date[7] - Zervimesine has shown a consistent safety profile, with adverse events balanced between treatment and placebo groups[57] Regulatory and Development Plans - The company plans to advance Zervimesine for DLB psychosis based on strong signals in behavioral and psychiatric symptoms[17] - Zervimesine is expected to be the first-to-market treatment for neuropsychiatric symptoms of dementia with Lewy bodies (DLB)[10] - The company received Fast Track designation for Zervimesine in Alzheimer's disease[10] - A new IND is required to transition to the FDA Division of Psychiatry, with a meeting scheduled for mid-May 2026[39] Study Details - The Phase 2 study enrolled 153 participants across multiple countries, with a mean MMSE score of 21.37 at entry[47] - The treatment period for the Phase 2 study was 6 months, focusing on safety, tolerability, and exploratory cognitive assessments[47] - The ongoing START study has completed enrollment with 545 participants, and topline results are anticipated in the second half of 2027[60] - The Expanded Access Program for DLB enrolled 32 participants, focusing on long-term safety and continued access to medication[36] Intellectual Property - Robust intellectual property protection for Zervimesine extends through 2040 with patent term extension[7] - The Phase 2 study of zervimesine in mild-to-moderate Alzheimer's disease was well-executed and over-enrolled, supporting further clinical development[46]