Cognition Therapeutics (NASDAQ:CGTX), a clinical-stage biopharmaceutical company developing next-generation therapies for neurodegenerative disorders, today reported financial results for the full year ended December 31, 2025, and provided a comprehensive update on its lead candidate, zervimesine (CT1812).
The company enters 2026 with a strengthened regulatory strategy and a fully funded clinical pipeline following landmark progress in its dementia with Lewy bodies (DLB) and Alzheimer’s disease programs.
A primary highlight of the fiscal year was the clinical validation of zervimesine in the Phase 2 SHIMMER study.
The trial demonstrated meaningful therapeutic responses in patients suffering from DLB psychosis, a condition with high unmet medical need and no currently approved disease-modifying therapies.
Building on this momentum, Cognition announced plans for a mid-2026 meeting with the FDA Division of Psychiatry to align on a registrational plan that could pave the way for a New Drug Application (NDA) in the DLB psychosis indication.
In the company’s Alzheimer’s disease program, the 545-patient Phase 2 START study has successfully completed enrollment.
This large-scale trial is designed to evaluate the long-term efficacy of zervimesine in slowing cognitive decline by preventing toxic amyloid-beta oligomers from binding to neuronal receptors.
The completion of enrollment marks a significant operational milestone, with data from this study expected to serve as a major value inflection point for the company's neuroprotective platform.
Financially, Cognition reported a net loss of $23.5 million for 2025, or $0.32 per basic and diluted share.
The company maintains a robust capital position, ending the year with approximately $37.0 million in cash and equivalents.
This is further supplemented by $35.7 million in obligated grant funds from the National Institutes of Health (NIH), which specifically support the START and SHIMMER trials.
Management estimates that this combined liquidity provides a sufficient financial runway through the second quarter of 2027.