[Cautionary Note on Forward-Looking Statements](index=3&type=section&id=Cautionary%20Note%20on%20Forward-Looking%20Statements) [Forward-Looking Statements Overview](index=3&type=section&id=Forward-Looking%20Statements%20Overview) This section cautions readers about forward-looking statements and the inherent risks that may cause actual results to differ - The report contains forward-looking statements identifiable by terms like 'anticipate,' 'expect,' 'will,' and 'may,' which are subject to risks and uncertainties that could cause actual results to differ materially[8](index=8&type=chunk) - Key risks include the ability to raise additional capital, maintain Nasdaq listing, successful clinical trial advancement, regulatory approvals, profitability, and dependence on zervimesine (CT1812)[8](index=8&type=chunk)[11](index=11&type=chunk) - Readers are directed to the 'Risk Factors' section of the Annual Report for a comprehensive discussion of material factors[9](index=9&type=chunk) [PART I – FINANCIAL INFORMATION](index=7&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=7&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited consolidated financial statements, detailing the company's financial position, performance, and cash flows [Consolidated Balance Sheets](index=7&type=section&id=Consolidated%20Balance%20Sheets) Consolidated Balance Sheets (in thousands) | Metric (in thousands) | June 30, 2025 | December 31, 2024 | Change | % Change | | :-------------------- | :------------ | :---------------- | :----- | :------- | | Cash and cash equivalents | $10,743 | $25,009 | $(14,266) | -57.0% | | Total current assets | $19,049 | $29,555 | $(10,506) | -35.5% | | Total assets | $19,622 | $30,234 | $(10,612) | -35.1% | | Total current liabilities | $12,364 | $11,142 | $1,222 | 11.0% | | Total liabilities | $12,593 | $11,484 | $1,109 | 9.7% | | Total stockholders' equity | $7,029 | $18,750 | $(11,721) | -62.5% | [Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change | % Change | | :-------------------- | :------------------------------- | :------------------------------- | :----- | :------- | | Research and development | $11,481 | $11,577 | $(96) | -0.8% | | General and administrative | $2,497 | $3,101 | $(604) | -19.5% | | Total operating expenses | $13,978 | $14,678 | $(700) | -4.8% | | Grant income | $7,106 | $7,311 | $(205) | -2.8% | | Net loss | $(6,734) | $(7,041) | $307 | -4.4% | | Basic Net loss per share | $(0.11) | $(0.18) | $0.07 | -38.9% | Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Metric (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change | % Change | | :-------------------- | :----------------------------- | :----------------------------- | :----- | :------- | | Research and development | $22,267 | $22,130 | $137 | 0.6% | | General and administrative | $5,486 | $6,650 | $(1,164) | -17.5% | | Total operating expenses | $27,753 | $28,780 | $(1,027) | -3.6% | | Grant income | $12,192 | $12,223 | $(31) | -0.3% | | Net loss | $(15,214) | $(16,192) | $978 | -6.0% | | Basic Net loss per share | $(0.24) | $(0.44) | $0.20 | -45.5% | [Consolidated Statements of Stockholders' Equity](index=9&type=section&id=Consolidated%20Statements%20of%20Stockholders'%20Equity) Consolidated Statements of Stockholders' Equity (in thousands, except shares) | Metric (in thousands, except shares) | December 31, 2024 | June 30, 2025 | | :----------------------------------- | :---------------- | :------------ | | Common Stock Shares Outstanding | 59,854,877 | 64,962,957 | | Common Stock Amount | $60 | $65 | | Additional Paid-in Capital | $193,850 | $197,338 | | Accumulated Deficit | $(175,160) | $(190,374) | | Total Stockholders' Equity | $18,750 | $7,029 | - Issuance of common stock under the ATM sales agreement contributed **$1,460 thousand** (March 31, 2025) and **$877 thousand** (June 30, 2025) to additional paid-in capital[23](index=23&type=chunk) - Equity-based compensation recognized was **$586 thousand** (March 31, 2025) and **$621 thousand** (June 30, 2025)[23](index=23&type=chunk) [Consolidated Statements of Cash Flows](index=11&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Consolidated Statements of Cash Flows (in thousands) | Metric (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change | | :-------------------- | :----------------------------- | :----------------------------- | :----- | | Net cash used in operating activities | $(15,500) | $(13,241) | $(2,259) | | Net cash used in investing activities | $0 | $(3) | $3 | | Net cash provided by financing activities | $2,048 | $11,855 | $(9,807) | | Net decrease in cash, cash equivalents and restricted cash equivalents | $(13,452) | $(1,389) | $(12,063) | | Cash, cash equivalents, and restricted cash equivalents – end of period | $11,557 | $28,533 | $(16,976) | [Notes to Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) - The Company is a biopharmaceutical company developing disease-modifying therapies for age-related degenerative diseases of the CNS and retina, incorporated in Delaware on August 21, 2007[29](index=29&type=chunk) - The Company has incurred recurring losses since inception, with a net loss of **$15,214 thousand** for the six months ended June 30, 2025, and an accumulated deficit of **$190,374 thousand**[32](index=32&type=chunk) - As of August 7, 2025, the Company believes its cash and cash equivalents are insufficient to fund operations for the next year, indicating substantial doubt about its ability to continue as a going concern[33](index=33&type=chunk) Grant Income (in thousands) | Period | 2025 | 2024 | | :----- | :--- | :--- | | Three Months Ended June 30 | $7,106 | $7,311 | | Six Months Ended June 30 | $12,192 | $12,223 | - Grant income is primarily from NIA reimbursements for aging research, with deferred grant income increasing from **$1,066 thousand** (Dec 31, 2024) to **$1,982 thousand** (June 30, 2025)[41](index=41&type=chunk) - Research and development costs are expensed as incurred, focusing on Alzheimer's disease, dementia with Lewy bodies (DLB), and geographic atrophy (GA)[43](index=43&type=chunk) Equity-based Compensation Expense (in thousands) | Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $331 | $282 | $641 | $513 | | General and administrative | $290 | $865 | $566 | $1,805 | | Total | $621 | $1,147 | $1,207 | $2,318 | - The Company operates as one operating segment focused on neurodegenerative disorders, with the CEO as the chief operating decision maker[54](index=54&type=chunk)[95](index=95&type=chunk) - The Company is an emerging growth company and has elected to use the extended transition period for complying with new or revised accounting standards[55](index=55&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=32&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section analyzes the company's financial condition, operational results, liquidity, and capital resources for the reported periods [Overview](index=32&type=section&id=Overview) - Cognition Therapeutics is a clinical-stage biopharmaceutical company developing small molecule therapeutics for age-related degenerative diseases of the CNS and retina, focusing on Alzheimer's disease, DLB, and GA secondary to dAMD[101](index=101&type=chunk) - The lead candidate, zervimesine (CT1812), targets the σ-2 (sigma-2) receptor (S2R) complex to antagonize amyloid beta oligomer binding and toxicity, showing improved synapse function in clinical trials[102](index=102&type=chunk) - Phase 2 SHINE study (Alzheimer's disease) met primary endpoints of safety and tolerability. A prespecified analysis showed a **95% reduction in cognitive decline** at week 26 in participants with baseline plasma p-tau217 below the median, relative to placebo[103](index=103&type=chunk)[104](index=104&type=chunk)[105](index=105&type=chunk) - Phase 2 SHIMMER study (DLB) met primary endpoints of safety and tolerability, with zervimesine-treated patients showing significant benefits across behavioral, functional, cognitive, and motor scales compared to placebo[110](index=110&type=chunk)[111](index=111&type=chunk) - Phase 2 MAGNIFY study (GA secondary to dry AMD) was voluntarily concluded. Top-line results showed zervimesine-treated participants had **29% slower GA lesion growth** on average and **28% smaller lesions** at 18 months compared to placebo, with effects widening over time[113](index=113&type=chunk)[114](index=114&type=chunk) - Zervimesine was generally well tolerated across all three Phase 2 studies, with transient liver enzyme test increases observed in **9.6%** of zervimesine-treated participants, which subsided after drug cessation[115](index=115&type=chunk)[116](index=116&type=chunk) - The company has received approximately **$140.4 million** in net proceeds from equity sales and convertible notes since inception, and **$171.0 million** in cumulative grants primarily from the NIA[117](index=117&type=chunk) [Components of Our Results of Operations](index=39&type=section&id=Components%20of%20Our%20Results%20of%20Operations) - Research and development expenses include direct costs (lab materials, contracted research, clinical trials) and indirect costs (personnel, facilities). These costs are expensed as incurred[127](index=127&type=chunk)[128](index=128&type=chunk) - General and administrative expenses primarily cover personnel costs (salaries, benefits, stock-based compensation) for executive, finance, and administrative functions, as well as third-party costs like legal, insurance, and accounting fees[130](index=130&type=chunk) - Grant income is recognized from government and non-government parties as allowable costs are incurred, primarily from NIA for clinical trials[131](index=131&type=chunk)[133](index=133&type=chunk) [Results of Operations](index=41&type=section&id=Results%20of%20Operations) Three Months Ended June 30, 2025 vs. 2024 (in thousands) | Metric | 2025 | 2024 | Change | | :------------------------- | :--- | :--- | :----- | | Research and development | $11,481 | $11,577 | $(96) | | General and administrative | $2,497 | $3,101 | $(604) | | Grant income | $7,106 | $7,311 | $(205) | | Net loss | $(6,734) | $(7,041) | $307 | - The decrease in R&D expenses for the three months ended June 30, 2025, was primarily due to a decrease in personnel costs, partially offset by an increase in clinical programs and manufacturing costs[137](index=137&type=chunk)[143](index=143&type=chunk) - General and administrative expenses decreased by **$0.6 million** for the three months ended June 30, 2025, mainly due to a decrease in equity-based compensation, partially offset by increased employee compensation[138](index=138&type=chunk) Six Months Ended June 30, 2025 vs. 2024 (in thousands) | Metric | 2025 | 2024 | Change | | :-------------------- | :----------------------------- | :----------------------------- | :----- | | Research and development | $22,267 | $22,130 | $137 | | General and administrative | $5,486 | $6,650 | $(1,164) | | Grant income | $12,192 | $12,223 | $(31) | | Net loss | $(15,214) | $(16,192) | $978 | - The increase in R&D expenses for the six months ended June 30, 2025, was primarily due to increased Phase 2 trial activities, partially offset by decreases in personnel, manufacturing, and preclinical program costs[144](index=144&type=chunk)[148](index=148&type=chunk) - General and administrative expenses decreased by **$1.2 million** for the six months ended June 30, 2025, primarily due to a decrease in equity-based compensation, partially offset by increased professional fees[145](index=145&type=chunk) [Liquidity and Capital Resources](index=47&type=section&id=Liquidity%20and%20Capital%20Resources) - As of June 30, 2025, the company had **$11.6 million** in cash, cash equivalents, and restricted cash equivalents[151](index=151&type=chunk) - The company believes its existing cash, grant income, and proceeds from the March 2024 follow-on public offering will fund operations into the second quarter of 2026, assuming no usage from the remaining ATM or Lincoln Park Purchase Agreement[151](index=151&type=chunk) - The company expects to incur significant and increasing expenses and net losses, requiring substantial additional funding through equity offerings, debt financings, or collaborations[152](index=152&type=chunk)[153](index=153&type=chunk) Cash Flows (in thousands) | Category | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------- | :----------------------------- | :----------------------------- | | Cash flows used in operating activities | $(15,500) | $(13,241) | | Cash flows provided by financing activities | $2,048 | $11,855 | - Net cash used in operating activities increased by **$2.3 million**, primarily due to a decrease in non-cash adjustments (equity-based compensation) and an increase in grant receivables, partially offset by a decrease in net loss[159](index=159&type=chunk) - Net cash provided by financing activities decreased by **$9.8 million**, mainly due to lower proceeds from common stock issuance in the follow-on offering and ATM program compared to the prior year[161](index=161&type=chunk) Contractual Obligations as of June 30, 2025 (in thousands) | Category | Less than 1 Year | 1 to 3 Years | 3 to 5 Years | More than 5 Years | Total | | :-------------------- | :--------------- | :----------- | :----------- | :---------------- | :---- | | Operating lease obligations | $223 | $174 | $82 | $0 | $479 | | Other obligations | $41 | $0 | $0 | $0 | $41 | | Total | $264 | $174 | $82 | $0 | $520 | [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=55&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company is exempt from providing quantitative and qualitative disclosures about market risk due to its status as a 'smaller reporting company' - The company is exempt from providing quantitative and qualitative disclosures about market risk due to its status as a 'smaller reporting company'[173](index=173&type=chunk) [Item 4. Controls and Procedures](index=55&type=section&id=Item%204.%20Controls%20and%20Procedures) This section confirms the effectiveness of disclosure and internal controls over financial reporting as of June 30, 2025 - The President, CEO, and CFO concluded that disclosure controls and procedures were effective as of June 30, 2025[174](index=174&type=chunk) - Management concluded that internal control over financial reporting was effective as of June 30, 2025, based on the COSO framework[175](index=175&type=chunk) - There were no material changes in internal control over financial reporting during the most recent fiscal quarter[176](index=176&type=chunk) - Management acknowledges the inherent limitations of control systems, which can only provide reasonable, not absolute, assurance[177](index=177&type=chunk) [PART II – OTHER INFORMATION](index=56&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=56&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no material pending legal actions as of June 30, 2025, while acknowledging potential future disputes - As of June 30, 2025, the company is not aware of any pending legal actions that would materially adversely affect its business[179](index=179&type=chunk) - The company may become involved in disputes or regulatory inquiries in the ordinary course of business, and as a public company, is susceptible to litigation, including securities law claims[180](index=180&type=chunk) [Item 1A. Risk Factors](index=56&type=section&id=Item%201A.%20Risk%20Factors) This section references Annual Report risk factors and details new risks, including FDA operational impacts and potential Nasdaq delisting - Readers should consider risk factors from the Annual Report, with no material changes other than those specified[181](index=181&type=chunk) - Changes in funding or disruptions to staffing and operations of the FDA and other government agencies could hinder product development and approval, negatively impacting the business[182](index=182&type=chunk)[185](index=185&type=chunk) - The company received a deficiency letter from Nasdaq on September 12, 2024, for failing to maintain a minimum **$1.00** bid price. It was granted an extension until September 8, 2025, to regain compliance, with potential delisting if unsuccessful[189](index=189&type=chunk)[190](index=190&type=chunk)[191](index=191&type=chunk) - Failure to regain Nasdaq compliance could reduce liquidity, impact stock price, hinder access to capital markets, and impair the company's ability to continue as a going concern[192](index=192&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=58&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section reports no unregistered sales or repurchases of equity securities during the fiscal quarter ended June 30, 2025 - No unregistered sales of equity securities occurred during the fiscal quarter ended June 30, 2025[193](index=193&type=chunk) - There were no repurchases of company equity securities during the period[194](index=194&type=chunk) [Item 3. Defaults Upon Senior Securities](index=58&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities during the period - There were no defaults upon senior securities[195](index=195&type=chunk) [Item 4. Mine Safety Disclosures](index=58&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - This item is not applicable[196](index=196&type=chunk) [Item 5. Other Information](index=58&type=section&id=Item%205.%20Other%20Information) No other information is reported under this item - No other information is reported under this item[197](index=197&type=chunk) [Item 6. Exhibits](index=60&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Quarterly Report, including governance documents, officer certifications, and XBRL files - Exhibits include the Third Amended and Restated Certificate of Incorporation, Second Amended and Restated Bylaws, and an Amendment to the Bylaws[199](index=199&type=chunk) - Certifications from the Principal Executive Officer and Principal Financial and Accounting Officer are included pursuant to Section 302 and Section 906 of the Sarbanes-Oxley Act of 2002[199](index=199&type=chunk) - Inline XBRL Instance Document and Taxonomy Extension Documents are also filed[199](index=199&type=chunk)

Core Insights - Cognition Therapeutics, Inc. presented positive results from the Phase 2 COG1201 SHIMMER study of zervimesine in dementia with Lewy bodies (DLB) at the Alzheimer's Association International Conference 2025 [1][2] - The SHIMMER study demonstrated zervimesine's significant impact on neuropsychiatric symptoms, with DLB patients showing an average of 86% improvement compared to placebo [2][3] - Zervimesine's efficacy in Alzheimer's disease was also highlighted in the Phase 2 SHINE study, where it was found to halt cognitive decline in patients with lower plasma p-tau217 levels by 129% and 91% for mild and moderate cases, respectively [4] Study Details - The SHIMMER study enrolled 130 adults with mild-to-moderate DLB, randomized to receive either zervimesine or placebo for six months [6][7] - The SHINE study included 153 adults with mild-to-moderate Alzheimer's disease, also randomized to receive zervimesine or placebo for six months [9][10] - Both studies met their primary endpoint of safety and tolerability, supported by approximately $30 million in grants from the National Institute on Aging [8][10] Biomarker Findings - Plasma p-tau217 levels were identified as a potential biomarker to predict which Alzheimer's patients would benefit most from zervimesine treatment [1][4] - Significant reductions in plasma glial fibrillary acidic protein (GFAP) were observed in SHINE participants with lower p-tau217 levels, indicating a potential impact on neuroinflammation [5][4] - The studies also showed trends towards normalization of neurofilament light (NfL) and amyloid beta species, suggesting zervimesine's influence on Alzheimer's disease biology [5][4] Company Overview - Cognition Therapeutics, Inc. focuses on developing innovative therapeutics for neurodegenerative disorders, with zervimesine as its lead candidate [13] - Zervimesine is an investigational oral medication aimed at treating Alzheimer's disease and DLB, targeting the toxic effects of protein buildup in the brain [11][13] - The company has received FDA Fast Track designation for zervimesine in Alzheimer's disease, indicating its potential significance in addressing unmet medical needs [11]

Core Insights - Cognition Therapeutics, Inc. presented positive results from the Phase 2 COG1201 SHIMMER study of zervimesine in dementia with Lewy bodies (DLB) at the Alzheimer's Association International Conference 2025 [1][2] - Zervimesine treatment showed an 86% improvement in neuropsychiatric symptoms compared to placebo after six months [2] - The SHINE study results indicated that lower plasma p-tau217 levels can identify Alzheimer's patients more likely to benefit from zervimesine treatment [3][4] Study Results - The SHIMMER study met its primary endpoint of safety and tolerability, with zervimesine showing a positive impact across various scales [2][6] - DLB patients treated with zervimesine scored significantly better on the neuropsychiatric inventory, particularly in symptoms like hallucinations and anxiety [2][3] - The SHINE study also met its primary endpoint, with zervimesine arresting cognitive deterioration by 129% in mild Alzheimer's and 91% in moderate Alzheimer's patients [4][9] Biomarker Analysis - Plasma p-tau217 levels were used to identify patients likely to benefit from zervimesine, with significant reductions in neuroinflammation markers observed [4][5] - The study found trends towards normalization of neurofilament light (NfL) and amyloid beta species in patients with lower p-tau217 levels [5][4] - Zervimesine's impact on neuroinflammation and neurodegeneration was supported by biomarker evidence presented at the conference [5][4] Company Overview - Cognition Therapeutics is focused on developing innovative therapeutics for neurodegenerative disorders, with zervimesine as a lead candidate [11][13] - The company has received significant funding from the National Institute on Aging, totaling approximately $30 million for both the SHIMMER and SHINE studies [8][10] - Zervimesine has been granted FDA Fast Track designation for Alzheimer's disease, indicating its potential significance in treatment [11]

Core Insights - Cognition Therapeutics, Inc. published results from the Phase 2 SEQUEL study of zervimesine (CT1812) for treating mild-to-moderate Alzheimer's disease, indicating potential neuroprotective effects and improvements in neuronal function [1][2][3] Study Findings - The SEQUEL study demonstrated that zervimesine treatment led to consistent improvements in EEG parameters, particularly a reduction in theta wave frequencies associated with Alzheimer's disease after 29 days [2][11] - Zervimesine was linked to enhanced global alpha AEC-c, indicating improved functional connectivity between brain regions, with significant protein alterations related to vesicle formation and cellular transport functions [3][4] - In vitro experiments showed that zervimesine preserved neuronal health under oxidative stress conditions, maintaining cell viability and structural integrity in the presence of 4-Hydroxynonenal (4-HNE), a known inducer of oxidative stress [5][6][7] Company Overview - Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related neurodegenerative disorders, with zervimesine being a lead candidate currently in multiple Phase 2 studies [8][9] - Zervimesine has received FDA Fast Track designation for Alzheimer's disease, highlighting its potential therapeutic benefits [9][10] SEQUEL Study Details - The SEQUEL study enrolled 16 adults with mild-to-moderate Alzheimer's disease, randomized to receive either 300mg of zervimesine or placebo for 29 days, followed by a crossover to the alternate treatment [11][12]

Core Insights - Cognition Therapeutics, Inc. conducted a positive end-of-Phase 2 meeting with the FDA regarding zervimesine (CT1812) for Alzheimer's disease treatment [1][2] - The SHINE Study demonstrated safety and tolerability, meeting its primary endpoints with 153 participants [4] - Zervimesine has been adopted as the United States Adopted Name (USAN) for CT1812 [3] Company Overview - Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related neurodegenerative disorders [6] - The company is advancing zervimesine through various clinical studies, including ongoing trials for dementia with Lewy bodies and early Alzheimer's disease [6] Study Details - The SHINE Study was a double-blind, placebo-controlled Phase 2 trial that enrolled 153 adults with mild-to-moderate Alzheimer's disease, assessing cognitive and functional changes [4] - The study received approximately $30 million in grant support from the National Institute on Aging [5] Drug Mechanism - Zervimesine is an investigational oral medication that targets the toxic effects of Aβ and ɑ-synuclein proteins associated with neurodegenerative diseases [2][6] - The drug aims to slow disease progression and improve the quality of life for patients suffering from Alzheimer's and dementia with Lewy bodies [2]

Core Viewpoint - Cognition Therapeutics, Inc. has announced that the Phase 2 'START' Study has surpassed 50% enrollment, indicating strong interest in their investigational drug zervimesine for treating early Alzheimer's disease [1][2][3] Company Overview - Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related degenerative disorders of the central nervous system [9][10] - The company is currently advancing zervimesine (CT1812), an oral treatment for Alzheimer's disease and dementia with Lewy bodies [5][9] Study Details - The START Study aims to enroll up to 540 individuals with mild Alzheimer's disease, who will receive either zervimesine or a placebo for 18 months [3][7] - The study is supported by an $81 million grant from the National Institute of Aging (NIA) and is conducted in collaboration with the Alzheimer's Clinical Trials Consortium (ACTC) [1][8] Treatment Mechanism - Zervimesine is designed to target the toxic effects of protein buildup in the brain, specifically Aβ and ɑ-synuclein, which are associated with neurodegenerative diseases [5][10] - The treatment has shown promise in previous studies, with the Phase 2 'SHINE' Study indicating a 38% slowing of cognitive decline compared to placebo, and a 95% slowing in participants with lower levels of p-tau217 [4][10] Clinical Significance - The START Study is significant as it targets participants who are just beginning to show signs of cognitive loss, potentially allowing for earlier intervention [4][7] - The study will assess cognitive function and safety using validated tools, contributing to the understanding of zervimesine's efficacy in early Alzheimer's disease [7][8]

Core Insights - Cognition Therapeutics, Inc. is advancing zervimesine (CT1812) into a Phase 3 program for mild-to-moderate Alzheimer's disease and has filed for breakthrough therapy designation for dementia with Lewy bodies (DLB) [1][2] Group 1: Clinical Development - An end-of-Phase 2 meeting with the FDA is scheduled for July 9, 2025, to discuss the Phase 2 'SHINE' study results and plans for a Phase 3 program for zervimesine in Alzheimer's disease [1] - The company is also progressing with an expanded access program for zervimesine in DLB, which has garnered high interest from former SHIMMER study participants [3] Group 2: Drug Information - Zervimesine (CT1812) is an investigational oral medication aimed at treating neurodegenerative diseases, specifically Alzheimer's disease and DLB, by potentially interrupting the toxic effects of protein buildup in the brain [4] - The drug has been generally well tolerated in clinical studies to date [4] Group 3: Company Overview - Cognition Therapeutics, Inc. focuses on developing small molecule therapeutics for age-related degenerative disorders of the central nervous system and has completed Phase 2 studies for zervimesine in multiple conditions [6]

Core Viewpoint - Cognition Therapeutics, Inc. is advancing its investigational drug zervimesine (CT1812) for the treatment of mild-to-moderate Alzheimer's disease and dementia with Lewy bodies (DLB), with an end-of-Phase 2 meeting scheduled with the FDA to discuss Phase 2 study results and plans for a Phase 3 program [1][2][8] Group 1: Clinical Development - The company will hold an end-of-Phase 2 meeting with the FDA on July 9, 2025, to review the Phase 2 'SHINE' study results of zervimesine in Alzheimer's disease [1] - Cognition is also moving forward with plans for a registrational program for DLB based on positive results from the Phase 2 'SHIMMER' study [2] - An expanded access program for zervimesine in DLB is underway, with high interest from former SHIMMER participants [3] Group 2: Drug Information - Zervimesine (CT1812) is an oral, once-daily investigational drug targeting neurodegenerative diseases, specifically Alzheimer's and DLB, by potentially interrupting the toxic effects of harmful proteins in the brain [4] - The drug has been generally well tolerated in clinical studies to date [4] - The USAN Council has adopted zervimesine as the official name for CT1812 [5] Group 3: Company Overview - Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related degenerative disorders of the central nervous system [6] - The company has completed Phase 2 studies for zervimesine in multiple conditions, including DLB and Alzheimer's disease, and is currently conducting an ongoing Phase 2 study in early Alzheimer's disease [6]

Company Overview - Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative small molecule therapeutics for age-related degenerative disorders of the central nervous system [7] - The company is currently investigating its lead candidate, zervimesine (CT1812), in clinical programs for dementia with Lewy bodies (DLB) and Alzheimer's disease [7] Expanded Access Program (EAP) - Cognition has received an anonymous philanthropic donation to fund an expanded access program for individuals with dementia with Lewy bodies [2] - The EAP will provide participants with 100 mg of oral zervimesine daily for approximately one year, starting with around 30 individuals [4] - The first site activated for the EAP is the Banner Sun Health Research Institute in Arizona, with Dr. David Shprecher as the primary investigator [2][5] Clinical Study and Collaboration - The EAP is based on the Phase 2 SHIMMER study, where zervimesine was administered to DLB patients [2] - Dr. James E. Galvin will serve as the lead investigator for the EAP, bringing his experience from the SHIMMER study [3][4] - The program aims to onboard additional participating sites rapidly to begin treatment for eligible patients [3] Future Prospects - Cognition aims to expand the EAP to accommodate more patients as funding and drug supply allow [4] - The company believes zervimesine can regulate impaired pathways in neurodegenerative diseases through its interaction with the sigma-2 receptor [7]

Core Insights - Cognition Therapeutics, Inc. has released its tenth episode of the Conversations video podcast, focusing on the lived experiences of caregivers for patients with Lewy body dementia [1][2] - The podcast features insights from caregivers and physician experts involved in Cognition's Phase 2 'SHIMMER' study, discussing the challenges and symptoms associated with dementia with Lewy bodies (DLB) [2] Company Overview - Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related neurodegenerative disorders [8] - The company is currently investigating its lead candidate, zervimesine (CT1812), in clinical programs for DLB and Alzheimer's disease [8][11] SHIMMER Study Details - The SHIMMER study is a Phase 2 clinical trial that enrolled 130 adults with mild-to-moderate DLB, randomized to receive either zervimesine or placebo for six months [6] - The study utilized various assessment tools, including the Neuropsychiatric Inventory and the Montreal Cognitive Assessment, to measure cognitive performance and symptoms [6] - The SHIMMER study received approximately $30 million in funding from the National Institute on Aging and was presented at the International Lewy Body Dementia Conference in January 2025 [7]