New Risk • Jun 25
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$91.3m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$20m free cash flow). Share price has been highly volatile over the past 3 months (22% average weekly change). Earnings are forecast to decline by an average of 30% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (44% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$105m net loss in 3 years). Market cap is less than US$100m (US$91.3m market cap). Announcement • Jun 25
Cognition Therapeutics Aligns on Key Aspects of Pivotal Study for Zervimesine (CT1812) in DLB Psychosis Following Receipt of FDA Meeting Minutes Cognition Therapeutics, Inc. received written feedback from the U.S. Food and Drug Administration (FDA) following its recent meeting. The FDA agreed that psychosis associated with dementia with Lewy bodies (DLB) could be an approvable outcome and reached alignment with the company on key aspects of a pivotal trial to support a New Drug Application (NDA). The registrational program is expected to begin in mid-2027. Cognition expects the Phase 3 study will enroll people with DLB who experience psychosis symptoms of hallucinations and delusions. Patients receiving stable background treatment with off-label antipsychotic medications will be eligible. Following screening, participants will be randomized to receive either 100 mg of once-daily oral zervimesine or placebo for nine months. The company will work with the FDA on the analytical and statistical details for the use of the neuropsychiatric inventory (NPI) as a novel primary endpoint for a pivotal trial in DLB psychosis. The proposed Phase 3 study builds on findings from Cognition's Phase 2 COG1201 ‘SHIMMER’ trial in mild-to-moderate DLB, which demonstrated improvements in psychosis symptoms with zervimesine versus placebo as measured by the NPI. In a recent analysis of results from the Phase 2 study, zervimesine slowed progression of hallucinations and delusions by 89%. In July, the company will present additional analyses from the Phase 2 study showing zervimesine’s impact on the hallucination and delusion components of the NPI at the Alzheimer’s Association’s International Conference (AAIC). Dementia with Lewy bodies (DLB) is a progressive, fatal neurodegenerative disease characterized by neuropsychiatric, cognitive and motor deficits. Up to 80% of people living with DLB experience psychosis, which manifests primarily as debilitating hallucinations and delusions. These symptoms are frequently cited as the most challenging for patients and their care partners to manage. There are no FDA-approved drugs for DLB, and the off-label use of traditional antipsychotics is often avoided due to the risk of severe and potentially life-threatening adverse reactions, underscoring a critical unmet need. Zervimesine (CT1812) is currently being studied in the Phase 2 START Study (NCT05531656) in patients with MCI and early Alzheimer’s disease. Phase 2 clinical studies have concluded in dementia with Lewy bodies (DLB), mild-to-moderate Alzheimer’s disease, and geographic atrophy secondary to dry AMD. Based in part on the strong efficacy signals observed in the Phase 2 SHIMMER study in DLB (NCT05225415), the company plans to advance zervimesine into a late-stage clinical trial for people with DLB psychosis. Zervimesine has been generally well tolerated in clinical studies to date. The USAN Council has adopted zervimesine as the United States Adopted Name (USAN) for CT1812. Announcement • Jun 16
Cognition Therapeutics Announces New Composition of Matter Patent Extending Patent Protection for Lead Candidate Zervimesine (CT1812) Through 2045 Cognition Therapeutics, Inc. announced that a Notice of Allowance has been received from the United States Patent and Trademark Office (USPTO) for patent application 19/563,468. The allowed patent covers a polymorphic crystalline form of zervimesine (CT1812), the company's lead drug candidate. Once issued, the patent will provide protection for this key formulation through 2045 and, if granted a standard 5-year extension, could offer protection through 2050. Titled “Crystalline forms of 2-(tert-butoxy)-4-(3-methyl-3-(5-(methylsulfonyl)isoindolin-2-yl)butyl)phenol fumarate salt,” this patent application covers: Composition of Matter: a polymorphic crystalline form of zervimesine. Production Process: A specialized, proprietary process for producing zervimesine. Therapeutic Methods: Methods of treating highly underserved, age-related degenerative disorders including Alzheimer’s disease, geographic atrophy, and dementia with Lewy bodies (DLB). While containing the same molecular components as the parent compound, the new configuration of this polymorphic form of zervimesine creates a more favorable pharmaceutical profile with greater thermodynamic and chemical stability. Cognition Therapeutics held productive discussions with the FDA in May regarding key aspects of its registrational program and is awaiting meeting minutes to confirm alignment on next steps. Cognition Therapeutics expects to employ this new form of zervimesine in those registrational trials of zervimesine for DLB psychosis. Zervimesine (CT1812) is currently being studied in the Phase 2 START Study (NCT05531656) in patients with MCI and early Alzheimer’s disease. Phase 2 clinical studies have concluded in dementia with Lewy bodies (DLB), mild-to-moderate Alzheimer’s disease, and geographic atrophy secondary to dry AMD. Based in part on the strong efficacy signals observed in the Phase 2 SHIMMER study in DLB (NCT05225415), Cognition Therapeutics plans to advance zervimesine into a late-stage clinical trial for people with DLB psychosis. Zervimesine has been generally well tolerated in clinical studies to date. The USAN Council has adopted zervimesine as the United States Adopted Name (USAN) for CT1812. 
