Cognition Therapeutics (NASDAQ:CGTX) is preparing a Phase III trial of its experimental drug zervimesine in dementia with Lewy bodies after reaching alignment with the U.S. Food and Drug Administration on a planned registrational study, executives said on the company’s third-quarter 2026 earnings call.
The company aims to begin the study in mid-2027 and is evaluating funding options. Chief Executive Officer Lisa Ricciardi said Cognition plans to submit a completed trial protocol to the FDA for review and is also assessing potential contract research partners and clinical sites.
Ricciardi said the FDA has agreed to consider a single pivotal trial, but whether the resulting data are sufficient will be a matter for regulatory review. Cognition is discussing financing with investors, bankers and potential strategic partners, she added.
Planned Trial to Focus on Hallucinations and Delusions
The proposed study would randomly assign participants with mild to moderate dementia with Lewy bodies, or DLB, to receive either 100 milligrams of oral zervimesine or a placebo once daily for nine months, Chief Medical Officer Dr. Tony Caggiano said.
The primary endpoint will use a measure known as NPI-2, which assesses the frequency and severity of hallucinations and delusions. A scale measuring activities of daily living will serve as a key secondary endpoint. The company also plans to enroll a population enriched with participants who have hallucinations and delusions at baseline.
Caggiano said measuring disease progression in DLB is challenging because biomarkers are not yet available for that purpose, and fluctuations in attention and cognition can complicate cognitive testing. He said Cognition and the FDA agreed that changes in psychosis could be used as a proxy for changes in underlying disease progression.
The company is developing zervimesine with the aim of slowing disease progression rather than solely treating symptoms. Caggiano said the drug binds to the sigma-2 receptor and that Cognition believes it protects neurons from toxic proteins. He also said the drug does not bind to or remove plaque and that the company would not expect a risk of amyloid-related imaging abnormalities, or ARIA.
In the earlier Phase II SHIMMER study, zervimesine met its primary safety and tolerability goals, Caggiano said. He added that progression of psychosis symptoms was slowed by 89% with treatment and that results across motor symptoms, fluctuations, cognition and neuropsychiatric symptoms supported the company’s view that the drug could modify the disease.
Asked about trial costs, Caggiano said Cognition had initially contemplated a study of about 750 participants costing roughly $150 million. Following discussions with the FDA about the endpoint, he said, the company believes it can conduct a well-powered registrational trial with fewer than half that number of participants. He did not provide a revised cost estimate.
Alzheimer’s Study and Financial Results
Cognition is also conducting START, a Phase II study of zervimesine in mild cognitive impairment and early Alzheimer’s disease. Ricciardi said the 545-person trial is fully enrolled and fully funded with non-dilutive capital from the National Institute on Aging. The company expects top-line results in the second half of 2027.
Caggiano said the company has not released or analyzed START’s baseline data for comparison with the low-tau subgroup from its earlier SHINE study. He said a forthcoming presentation would discuss recruitment methods, but baseline data would not yet be presented.
Chief Financial Officer John Doyle reported that Cognition had approximately $31.5 million in cash, cash equivalents and restricted cash equivalents as of September 30, 2026. The company also had $18.2 million in remaining obligated grant funds from the National Institute on Aging. At its current spending rate, Cognition expects its cash to fund operations and capital expenditures into the fourth quarter of 2027.
Research and development expenses rose to $5.1 million in the third quarter from $3.8 million a year earlier, driven by higher trial activity and professional fees. General and administrative expenses fell to $2.3 million from $2.6 million.
Cognition reported a third-quarter net loss of $4.1 million, or $0.04 per basic and diluted share, compared with a loss of $4.9 million, or $0.06 per share, in the prior-year period.
About Cognition Therapeutics (NASDAQ:CGTX)
Cognition Therapeutics, Inc is a clinical-stage biotechnology company focused on developing therapies for neurodegenerative diseases. The company’s research centers on the sigma-2 receptor, also known as the sigma-2 receptor complex or PGRMC1, a target believed to play a role in the cellular mechanisms associated with synaptic dysfunction and neurodegeneration.
Cognition Therapeutics’ lead product candidate is CT1812, an orally administered small-molecule therapy designed to modulate the sigma-2 receptor complex.
