Cognition Therapeutics(CGTX) - 2025 Q1 - Quarterly Results

Introduction and First Quarter 2025 Overview Cognition Therapeutics reported Q1 2025 financial results and business updates, highlighting progress in Alzheimer's disease and dementia with Lewy bodies programs Executive Summary Cognition Therapeutics reported its financial results for the first quarter ended March 31, 2025, and provided a business update, highlighting significant progress in its Alzheimer's disease and dementia with Lewy bodies (DLB) programs - Requested an End-of-Phase 2 (EOP2) meeting with the FDA for the Alzheimer's disease program[1][6] - Phase 2 results in dementia with Lewy bodies (DLB) accepted for oral presentation at the Alzheimer's Association International Congress (AAIC)[1][6] - Two posters at ARVO describe zervimesine's role in supporting retinal cell health[1][6] Business and Corporate Highlights This section details the company's strategic advancements and key operational achievements in its clinical programs CEO Commentary and Strategic Progress CEO Lisa Ricciardi highlighted the continued advancement of the company's Alzheimer's disease and DLB programs, including a formal request for an EOP2 meeting with the FDA for Alzheimer's and the initiation of a commercial IND application for zervimesine in DLB to facilitate a separate EOP2 meeting - A request was made with the U.S. Food and Drug Administration to schedule an EOP2 meeting to review SHINE study results in Alzheimer's disease and discuss plans for a registrational study[2][6] - Initiated the process of securing a commercial investigational new drug (IND) application for zervimesine (CT1812) in DLB to enable a separate EOP2 meeting for this indication[2] Key Operational Achievements Cognition Therapeutics achieved several key operational milestones, including the acceptance of Phase 2 SHIMMER study results for an oral presentation at AAIC and presentations at ARVO and ILBDC - Phase 2 'SHIMMER' study results in DLB were accepted for a podium presentation at the Alzheimer's Association International Congress (AAIC), scheduled for July 27-31, 2025[6] - Presented two posters at the Association for Research in Vision and Ophthalmology (ARVO) meeting, describing zervimesine's role in regulating lipid metabolism and protecting retinal cells[6] - Results from the Company's Phase 2 'SHIMMER' study were presented at the International Lewy Body Dementia Conference (ILBDC) in January 2025[6] First Quarter 2025 Financial Results This section provides an overview of the company's financial performance for the first quarter of 2025, including liquidity, operating expenses, and net loss Liquidity and Cash Position As of March 31, 2025, Cognition Therapeutics reported its cash and cash equivalents, along with remaining obligated grant funds, and provided an estimate for its cash runway Cash and Grant Funds (as of March 31, 2025): | Metric | Amount (Millions) | | :--------------------- | :---------------- | | Cash and cash equivalents | $16.4 | | Obligated grant funds | $47.0 | - The Company estimates that it has sufficient cash to fund operations and capital expenditures into the fourth quarter of 2025[4] Operating Expenses Analysis Research and development (R&D) expenses saw a slight increase, primarily driven by Phase 2 trial activities, while general and administrative (G&A) expenses decreased due to lower stock compensation Operating Expenses (Three Months Ended March 31): | Expense Category | Q1 2025 (Millions) | Q1 2024 (Millions) | Change (YoY) | Primary Driver | | :------------------- | :----------------- | :----------------- | :----------- | :------------- | | Research and development | $10.8 | $10.6 | +$0.2 | Increased Phase 2 trial activities | | General and administrative | $3.0 | $3.5 | -$0.5 | Lower stock compensation | Net Loss and Per Share Data The company reported a reduced net loss and improved net loss per share for the first quarter of 2025 compared to the prior year period Net Loss and EPS (Three Months Ended March 31): | Metric | Q1 2025 | Q1 2024 | Change (YoY) | | :------------------- | :------ | :------ | :----------- | | Net loss | $(8.5) million | $(9.2) million | -$0.7 million | | Net loss per share (Basic & Diluted) | $(0.14) | $(0.27) | +$0.13 | Consolidated Financial Statements This section presents the detailed consolidated financial statements, including statements of operations and balance sheet data Consolidated Statements of Operations The consolidated statements of operations provide a detailed breakdown of the company's revenues, expenses, and net loss for the three months ended March 31, 2025, and 2024 Consolidated Statements of Operations Data (in thousands, except share and per share data amounts): | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------------------------------ | :-------------------------------- | :-------------------------------- | | Operating Expenses: | | | | Research and development | $10,786 | $10,553 | | General and administrative | 2,989 | 3,549 | | Total operating expenses | 13,775 | 14,102 | | Loss from operations | (13,775) | (14,102) | | Other income (expense): | | | | Grant income | 5,086 | 4,912 | | Other income, net | 214 | 244 | | Interest expense | (5) | (10) | | Loss on currency translation from liquidation of subsidiary | — | (195) | | Total other income, net | 5,295 | 4,951 | | Net loss | $(8,480) | $(9,151) | | Foreign currency translation adjustment, including reclassifications | — | 195 | | Total comprehensive loss | $(8,480) | $(8,956) | | Net loss per share: | | | | Basic | $(0.14) | $(0.27) | | Diluted | $(0.14) | $(0.27) | | Weighted-average common shares outstanding: | | | | Basic | 61,828,149 | 33,735,269 | | Diluted | 61,828,149 | 33,735,269 | Consolidated Balance Sheet Data The consolidated balance sheet data presents the company's financial position, including assets, liabilities, and equity, as of March 31, 2025, compared to December 31, 2024 Consolidated Balance Sheet Data (in thousands): | Metric | As of March 31, 2025 | As of December 31, 2024 | | :----------------------- | :------------------- | :--------------------- | | Cash and cash equivalents | $16,428 | $25,009 | | Total assets | 23,500 | 30,234 | | Total liabilities | 11,230 | 11,484 | | Accumulated deficit | (183,640) | (175,160) | | Total stockholders' equity | 12,270 | 18,750 | About Cognition Therapeutics, Inc. This section provides an overview of Cognition Therapeutics, a clinical-stage biopharmaceutical company focused on neurodegenerative disorders Company Profile and Therapeutic Focus Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative small molecule therapeutics for age-related neurodegenerative disorders, with its lead candidate zervimesine (CT1812) targeting DLB and Alzheimer's disease - Cognition Therapeutics is a clinical-stage biopharmaceutical company discovering and developing innovative, small molecule therapeutics targeting age-related degenerative disorders of the central nervous system[9] - The lead candidate, zervimesine (CT1812), is currently being investigated in clinical programs for dementia with Lewy bodies (DLB) and Alzheimer's disease[9] - Zervimesine is believed to regulate pathways impaired in these diseases through its interaction with the sigma-2 receptor, a functionally distinct mechanism[9] Forward-Looking Statements This section contains a standard legal disclaimer regarding forward-looking statements and associated risks Disclaimer This section contains a standard legal disclaimer, emphasizing that the press release includes forward-looking statements that are subject to various risks, uncertainties, and factors that could cause actual results to differ materially from those projected - This press release contains forward-looking statements regarding cash runway, clinical studies of zervimesine, expected benefits, clinical development plans, and regulatory approval[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 projections[10] - The company does not plan to publicly update or revise any forward-looking statements contained herein, except as required by applicable law[10] Contact Information This section provides contact details for investor and media inquiries Investor and Media Relations Contact details are provided for media and investor inquiries regarding Cognition Therapeutics - Contact information for media inquiries (Casey McDonald at Tiberend Strategic Advisors) and investor inquiries (Mike Moyer at LifeSci Advisors) is provided[11]