CGTX — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-08

• We are a clinical-stage biopharmaceutical company engaged in the discovery and development of innovative, small molecule therapeutics targeting age-related degenerative diseases and disorders of the central nervous system (“CNS”). Currently available therapies for these diseases are limited, with fe…

• Our lead product candidate, zervimesine, also known as CT1812, is an orally delivered, small molecule designed to protect neuronal synapses by preventing the binding of oligomers of pathogenic proteins including β-amyloid, or Aβ and ɑ-synuclein. These and similar protein oligomers have been linked t…

• The United States Adopted Name (USAN) Council adopted zervimesine as the USAN for CT1812 in December 2024.

• Enrollment concluded in December 2025 in the Phase 2 COG0203 (START) study of zervimesine in 545 patients with mild cognitive impairment (MCI) and early stage AD. Topline results are expected after all participants have completed 18 months of treatment. START has been funded by a grant of approximat…

• In July 2025, we conducted an end-of-Phase 2 meeting with the FDA to review results of the SHINE study and discuss proposed plans for a Phase 3 program designed to support regulatory approval of zervimesine in this patient population. FDA concurred with the proposed study design, which would randomi…

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• We are a clinical-stage biopharmaceutical company engaged in the discovery and development of innovative, small molecule therapeutics targeting age-related degenerative diseases and disorders of the central nervous system (“CNS”) and retina. Currently available therapies for these diseases are limit…

• Our lead candidate for the treatment of age-related degenerative diseases is zervimesine (CT1812). Data indicate that zervimesine antagonizes the binding and toxicity of amyloid beta oligomers via targeting the S2R complex and represents a mechanism that is functionally distinct from other current a…

• Top-line results from the Phase 2 COG0201 SHINE study were reported in July 2024 with additional data reported in October 2024. An end-of-Phase 2 meeting was conducted on July 9, 2025 to review the results of the SHINE study and Cognition’s proposed plan for a Phase 3 clinical program with the U.S. …

• SHINE was a randomized, double-blind, placebo-controlled trial that enrolled 153 adults with mild-to-moderate Alzheimer’s disease. Participants were evenly randomized into two zervimesine dose groups (100 mg or 300 mg) and one placebo group, who were dosed daily for six months. Endpoints included sa…

• In the overall modified intent-to-treat population in SHINE, participants treated with once-daily oral zervimesine experienced less cognitive decline than those treated with placebo. As measured with ADAS-Cog 11, zervimesine-treated participants (pooled 100 mg and 300 mg) experienced a mean 38% slow…

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• Changes in funding for, or disruptions to the staffing and operations of the FDA and other government agencies could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a …

• Currently, federal agencies in the U.S. are operating under federal government shutdown due to expiration of the a continuing resolution on September 30, 2025. The duration of the current government shutdown is unknown. Without appropriation of additional funding to federal agencies, our business op…

• Disruptions at the FDA and other federal agencies, including substantial leadership departures, personnel cuts, and policy changes, may also slow the time necessary for new drugs to be reviewed and/or approved, which would harm our business. Changes and cuts in FDA staffing have been reported within…

• A prolonged government shutdown or significant leadership, personnel, and/or policy changes, or other substantial modification in agency activities (including due to global health concerns or geopolitical factors) could significantly impact the ability of the FDA or other regulatory authorities to t…

• With the change in the U.S. presidential administration in 2025, there is substantial uncertainty as to whether and how the Trump administration will seek to modify or revise the requirements and policies of the FDA and other regulatory agencies with jurisdiction over our product candidates and any …