Core Insights - Cognition Therapeutics received FDA confirmation on the design of its Phase 3 program for zervimesine (CT1812) as a treatment for Alzheimer's disease, which may support a New Drug Application (NDA) filing [1][4] - The Phase 3 program will focus on enrolling adults with mild-to-moderate Alzheimer's disease who have lower levels of p-tau217, a biomarker indicating potential treatment efficacy [2][3] - Zervimesine has demonstrated a 95% reduction in cognitive deterioration compared to placebo in previous studies, supporting its potential effectiveness in the targeted population [2][4] Company Overview - Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for neurodegenerative disorders [9] - The company has completed Phase 2 studies for zervimesine in conditions such as dementia with Lewy bodies and mild-to-moderate Alzheimer's disease, with ongoing studies supported by significant grant funding [9][8] - Zervimesine is designed to interrupt the toxic effects of proteins associated with neurodegenerative diseases, potentially improving patient outcomes [5][9] Study Design and Strategy - The Phase 3 study will randomize participants to receive either 100mg of zervimesine or a placebo daily for six months, with efficacy and safety endpoints confirmed by the FDA [3][4] - The study will incorporate biomarker and imaging assessments to further support clinical outcomes, enhancing the robustness of the trial [3] - The FDA's agreement on the study design allows for faster and more cost-effective enrollment, expediting the regulatory filing process [4]

Executive Summary & Recent Developments [Second Quarter 2025 Overview](index=1&type=section&id=Second%20Quarter%202025%20Overview) 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](index=2&type=chunk) - Zervimesine shows promise in slowing the progression of age-related neurodegenerative diseases such as Alzheimer's, DLB, and dry AMD[2](index=2&type=chunk) [Business and Corporate Highlights](index=1&type=section&id=Business%20and%20Corporate%20Highlights) 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](index=1&type=section&id=Alzheimer's%20Disease%20Program) 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](index=5&type=chunk) - Minutes from the FDA End-of-Phase 2 meeting on zervimesine's Alzheimer's disease registration plan are expected later this month[4](index=4&type=chunk) - 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](index=1&type=chunk)[5](index=5&type=chunk) [Dementia with Lewy Bodies (DLB) Program](index=1&type=section&id=Dementia%20with%20Lewy%20Bodies%20(DLB)%20Program) 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](index=1&type=chunk)[5](index=5&type=chunk) - 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](index=5&type=chunk) - A Breakthrough Therapy Designation application for zervimesine in DLB has been submitted to the FDA, with a decision anticipated in **Q3 2025**[4](index=4&type=chunk)[5](index=5&type=chunk) [Dry Age-Related Macular Degeneration (dry AMD) Program](index=1&type=section&id=Dry%20Age-Related%20Macular%20Degeneration%20(dry%20AMD)%20Program) 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](index=5&type=chunk) - A comprehensive manuscript describing zervimesine's proposed mechanism of action in treating dry AMD/GA has been submitted to a peer-reviewed journal[5](index=5&type=chunk) [Other Corporate Activities](index=1&type=section&id=Other%20Corporate%20Activities) 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](index=5&type=chunk) - Evaluation of potential partnership options to support zervimesine's development continues[4](index=4&type=chunk) Financial Results [Second Quarter 2025 Financial Performance](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Performance) 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)](index=2&type=section&id=Financial%20Position%20(Balance%20Sheet)) 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](index=6&type=chunk) - The company estimates its existing cash is sufficient to fund operations and capital expenditures through **Q2 2026**[6](index=6&type=chunk) 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](index=2&type=section&id=About%20Cognition%20Therapeutics) 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](index=9&type=chunk) - 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](index=9&type=chunk) - 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](index=9&type=chunk) - 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](index=9&type=chunk) Forward-Looking Statements [Disclaimer on Forward-Looking Information](index=2&type=section&id=Disclaimer%20on%20Forward-Looking%20Information) 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](index=10&type=chunk) - 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](index=10&type=chunk) - 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](index=10&type=chunk) - 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](index=11&type=chunk)

[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]