Cognition Therapeutics Inc

Cognition Therapeutics reported a narrowed net loss for the second quarter of 2026 and announced plans to initiate a Phase 3 study of its lead candidate Zervimesine in dementia with Lewy bodies psychosis in mid-2027. Net loss shrank to $3.9 million, or $0.04 per share, from $6.7 million, or $0.11 per share, a year earlier. Cash and cash equivalents stood at approximately $34.8 million as of June 30, 2026, which the company estimates will fund operations into the fourth quarter of 2027. President and CEO Lisa Ricciardi said discussions with the FDA brought clarity on key aspects of the planned Phase 3 trial for DLB psychosis.

The dementia-related psychosis market across the seven major markets is forecast to expand at a compound annual growth rate of 26.2% from 2026 to 2036, according to a new report from DelveInsight. The market was valued at 690 million US dollars in 2025, with the United States accounting for approximately 77% of that total. More than 5 million diagnosed prevalent cases were reported across the seven major markets in 2025, including over 2 million in the US, where Alzheimer's disease dementia represented the largest share. Key therapies in development include ACP-204 from Acadia Pharmaceuticals, COBENFY from Bristol Myers Squibb, Zervimesine from Cognition Therapeutics, ML-007C-MA from Maplight Therapeutics, ITI-1284 from Johnson & Johnson, and low-dose levetiracetam from AgeneBio.

Cognition Therapeutics has reached alignment with the U.S. FDA on the design of a pivotal Phase 3 study evaluating Zervimesine for psychosis associated with dementia with Lewy bodies, a condition with no approved treatments. The FDA confirmed that DLB psychosis is an approvable clinical outcome and that the proposed trial framework is appropriate to support a future New Drug Application. The study will enroll individuals with DLB who experience hallucinations and delusions, including those on stable off-label antipsychotic therapy, randomizing them to 100 mg once-daily oral Zervimesine or placebo for nine months. The Neuropsychiatric Inventory will serve as a novel primary endpoint, with analytical and statistical details to be finalized with the FDA, and the registrational program is expected to begin mid-2027. The Phase 3 design builds on Phase 2 SHIMMER data showing Zervimesine improved psychosis symptoms, including an 89% slowing of hallucination and delusion progression in a recent analysis.