Cognition Therapeutics targets mid-2027 start for DLB psychosis Phase 3
The company said FDA talks clarified elements of the planned trial design, while it reported second-quarter 2026 results and a patent allowance for zervimesine.
Cognition Therapeutics reported second-quarter 2026 financial results and a business update on August 6, 2026. CEO Lisa Ricciardi said discussions with the FDA brought clarity on key aspects of the company's planned Phase 3 trial for people with dementia with Lewy bodies who experience psychosis, known as DLB psychosis.1 She added that the company is focused on starting the Phase 3 study in mid-2027 using an improved tablet formulation.1
On the regulatory front, the company said it held a planned meeting with the FDA to discuss the design of a registrational study in DLB psychosis, and will provide a timing update once endpoints are aligned.1 Separately, Cognition disclosed it received a Notice of Allowance covering a patent application for a polymorphic crystalline form of zervimesine, addressing composition of matter, the production process, and a therapeutic method for treating Alzheimer's disease and DLB. Once issued, the patent would extend protection through 2045, before any patent-term extension.1
The company also said it extended its expanded access program for zervimesine in DLB, with the extension running through 2027 and supported by a new philanthropic donor, according to the release's business highlights section. In addition, Cognition presented a poster at the Alzheimer's Association International Convention outlining a proposed Phase 3 study design for zervimesine in DLB psychosis.1
On financials, cash, cash equivalents, and restricted cash equivalents as of June 30, 2026 were approximately $34.8 million, with $21.6 million remaining in obligated grant funds from the National Institute of Aging.1 The company said its cash is projected to support operations and capital spending into the fourth quarter of 2027. Net loss for the quarter was $3.9 million, or $(0.04) per basic and diluted share, compared with a net loss of $6.7 million, or $(0.11) per share, in the same period of 2025.1
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