Cognition Therapeutics(CGTX) - 2025 Q2 - Quarterly Results

Executive Summary & Recent Developments Second Quarter 2025 Overview Cognition Therapeutics reported Q2 2025 financial results, highlighting zervimesine's clinical progress in Alzheimer's, DLB, and dry AMD - The second quarter of 2025 was productive, with milestone achievements across all clinical programs[2] - Zervimesine shows promise in slowing the progression of age-related neurodegenerative diseases such as Alzheimer's, DLB, and dry AMD[2] Business and Corporate Highlights Cognition Therapeutics achieved key Q2 2025 milestones, advancing Alzheimer's, DLB, and dry AMD clinical programs, alongside regulatory and scientific activities Alzheimer's Disease Program The company held an EOP2 meeting with the FDA for zervimesine's Alzheimer's registration plan and completed over 50% patient enrollment in the Phase 2 'START' study - A productive End-of-Phase 2 (EOP2) meeting was held with the FDA regarding zervimesine (CT1812) Phase 2 'SHINE' study results in Alzheimer's disease[5] - Minutes from the FDA End-of-Phase 2 meeting on zervimesine's Alzheimer's disease registration plan are expected later this month[4] - Enrollment in the zervimesine early Alzheimer's disease Phase 2 study, in collaboration with the Alzheimer's Clinical Trials Consortium (ACTC), has exceeded 50%[1][5] Dementia with Lewy Bodies (DLB) Program Cognition launched an EAP for DLB patients, announced Phase 2 'SHIMMER' study results, and applied for zervimesine's Breakthrough Therapy Designation in DLB - An Expanded Access Program (EAP) for patients with Dementia with Lewy Bodies (DLB) has been initiated, with three clinical sites onboarded[1][5] - Phase 2 'SHIMMER' study results for zervimesine in DLB were presented at the Alzheimer's Association International Conference (AAIC) in Toronto, Canada, on July 29[5] - A Breakthrough Therapy Designation application for zervimesine in DLB has been submitted to the FDA, with a decision anticipated in Q3 2025[4][5] Dry Age-Related Macular Degeneration (dry AMD) Program The company announced positive Phase 2 dry AMD study results, showing a 28.6% reduction in GA lesion growth, and submitted a manuscript on zervimesine's mechanism of action - Positive topline results from the Phase 2 dry AMD study reported a 28.6% reduction in geographic atrophy (GA) lesion growth compared to placebo after 18 months of once-daily oral zervimesine[5] - A comprehensive manuscript describing zervimesine's proposed mechanism of action in treating dry AMD/GA has been submitted to a peer-reviewed journal[5] Other Corporate Activities The company received a philanthropic donation for the DLB EAP and continues to evaluate potential partnership options for zervimesine's development - A philanthropic donation was received to support the EAP for former Phase 2 'SHIMMER' participants and other DLB patients[5] - Evaluation of potential partnership options to support zervimesine's development continues[4] Financial Results Second Quarter 2025 Financial Performance Cognition Therapeutics reported a net loss of $6.7 million in Q2 2025, an improvement from $7.0 million in Q2 2024, driven by reduced R&D and G&A expenses Net Loss and Loss Per Share (Q2 2025 vs Q2 2024) | Indicator | Q2 2025 (Thousands of USD) | Q2 2024 (Thousands of USD) | | :----------------------- | :--------------------- | :--------------------- | | Net Loss | $(6,734) | $(7,041) | | Basic Loss Per Share | $(0.11) | $(0.18) | | Diluted Loss Per Share | $(0.11) | $(0.18) | Operating Expenses (Q2 2025 vs Q2 2024) | Expense Category | Q2 2025 (Thousands of USD) | Q2 2024 (Thousands of USD) | Year-over-Year Change (Thousands of USD) | Primary Drivers of Change | | :----------------------- | :--------------------- | :--------------------- | :--------------------------------------- | :------------------------------ | | Research and Development Expenses | $11,481 | $11,577 | $(96) | Decrease in professional services fees | | General and Administrative Expenses | $2,497 | $3,101 | $(604) | Decrease in stock-based compensation expense | Grant Revenue (Q2 2025 vs Q2 2024) | Indicator | Q2 2025 (Thousands of USD) | Q2 2024 (Thousands of USD) | | :----------- | :--------------------- | :--------------------- | | Grant Revenue | $7,106 | $7,311 | Financial Position (Balance Sheet) As of June 30, 2025, Cognition Therapeutics held $11.6 million in cash, with existing funds and $41.9 million in NIA grants projected to support operations through Q2 2026 Cash Position (As of June 30, 2025 vs December 31, 2024) | Indicator | As of June 30, 2025 (Thousands of USD) | As of December 31, 2024 (Thousands of USD) | | :-------------------------------------- | :----------------------------- | :------------------------------- | | Cash, Cash Equivalents, and Restricted Cash Equivalents | $11,557 | $25,009 | - Remaining committed grant funding from the National Institute on Aging (NIA) totals $41.9 million[6] - The company estimates its existing cash is sufficient to fund operations and capital expenditures through Q2 2026[6] Balance Sheet Data (As of June 30, 2025 vs December 31, 2024) | Indicator | As of June 30, 2025 (Thousands of USD) | As of December 31, 2024 (Thousands of USD) | | :------------------ | :----------------------------- | :------------------------------- | | Total Assets | $19,622 | $30,234 | | Total Liabilities | $12,593 | $11,484 | | Accumulated Deficit | $(190,374) | $(175,160) | | Total Stockholders' Equity | $7,029 | $18,750 | Company Overview About Cognition Therapeutics Cognition Therapeutics is a clinical-stage biopharmaceutical company developing small molecule therapeutics for age-related CNS neurodegenerative diseases, with zervimesine completing Phase 2 studies and an ongoing Phase 2 START study funded by an $81 million NIA grant - Cognition Therapeutics is a clinical-stage biopharmaceutical company dedicated to discovering and developing innovative small molecule therapeutics for age-related neurodegenerative diseases of the central nervous system[9] - The lead product candidate is zervimesine (CT1812), which has completed Phase 2 studies in Dementia with Lewy Bodies (DLB), mild-to-moderate Alzheimer's disease, and dry Age-related Macular Degeneration secondary to geographic atrophy[9] - The ongoing early Alzheimer's disease Phase 2 START study (NCT05531656) is funded by an $81 million grant from the National Institute on Aging (NIA), part of the National Institutes of Health (NIH)[9] - Zervimesine modulates impaired pathways in these diseases by interacting with the sigma-2 receptor, offering a functionally distinct mechanism of action from other approaches to treating neurodegenerative diseases[9] Forward-Looking Statements Disclaimer on Forward-Looking Information This press release contains forward-looking statements subject to known and unknown risks and uncertainties, where actual results may differ materially, and no public updates are planned unless legally required - This press release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995, pertaining to cash flows, clinical studies of zervimesine (CT1812) and analysis of their results, anticipated or implied benefits or results of zervimesine, clinical development plans, and regulatory approval plans[10] - These statements involve known and unknown risks, uncertainties, and other important factors that may cause actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements[10] - Factors that could cause actual results to differ materially from current expectations include competition, the ability to obtain and retain grant funding, the ability to successfully advance product candidates, the timing and likelihood of regulatory filings and approvals, changes in laws and regulations, economic factors, and intellectual property[10] - The company does not plan to publicly update or revise any forward-looking statements contained in this press release unless required by applicable law[11]