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]

Core Insights - Cognition Therapeutics, Inc. reported promising preclinical data on zervimesine (CT1812) at the ARVO conference, indicating its potential to protect retinal pigment epithelial (RPE) cells from damage in dry age-related macular degeneration (dry AMD) [1][2][3] Company Overview - Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative small molecule therapeutics for age-related degenerative disorders of the central nervous system [9] - The company is currently investigating zervimesine in clinical programs for dementia with Lewy bodies and Alzheimer's disease, including the ongoing START study in early Alzheimer's disease [9] Product Details - Zervimesine is an investigational oral drug candidate that has shown the ability to reach therapeutic concentrations in the eye and is being studied for its effects on retinal cell health [2][4] - The drug binds to the sigma-2 receptor (TMEM97), which is crucial for retinal cell lipid uptake, a process impaired in dry AMD [2][3] - In a Phase 2 clinical trial, zervimesine slowed the rate of geographic atrophy lesion growth by 28.6% compared to placebo, resulting in smaller lesions for treated patients [4] Disease Context - Dry AMD accounts for up to 90% of age-related macular degeneration cases and leads to irreversible vision loss due to the death of retinal cells [6] - The disease is characterized by the accumulation of oxidized lipids and drusen, which damage RPE cells and contribute to vision loss [3][6] Research Findings - Preclinical research supports zervimesine's potential to protect retinal cells from oxidized lipids and enhance cellular function in degenerative diseases [2][3][4] - The drug has also shown robust clinical results in studies involving Alzheimer's disease and dementia with Lewy bodies, indicating its broader therapeutic potential [4][7]

Core Insights - Cognition Therapeutics, Inc. reported positive topline results from the Phase 2 COG2201 'MAGNIFY' trial of zervimesine (CT1812) for treating geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD), showing a 28.6% reduction in GA lesion growth rate and a 28.2% decrease in lesion size at 18 months compared to placebo [1][5][6] Company Overview - Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative small molecule therapeutics for age-related degenerative disorders of the central nervous system [12] - The company is currently investigating zervimesine in clinical programs for Alzheimer's disease and dementia with Lewy bodies (DLB) [12] Study Details - The MAGNIFY study was a double-masked, placebo-controlled Phase 2 clinical trial designed to enroll 246 adults with GA secondary to dry AMD, but was concluded early with approximately 100 participants enrolled [7][8] - Participants received either a placebo or 200 mg of once-daily oral zervimesine, with assessments for safety, tolerability, and changes in GA lesion size and growth rate [7] Treatment Potential - Zervimesine has shown efficacy signals in three indications, including dry AMD, Alzheimer's disease, and DLB, suggesting its potential as a monotherapy or in combination with existing medications [6][10] - The oral administration of zervimesine could provide a transformative alternative to current treatment options that require regular clinic visits for injections [2][6] Future Plans - Cognition Therapeutics plans to submit complete findings from the MAGNIFY study for presentation at a medical meeting later this year, with additional data on safety, demographics, and visual outcomes still being analyzed [5][6]

[Cautionary Note on Forward-Looking Statements](index=3&type=section&id=Cautionary%20Note%20on%20Forward-Looking%20Statements) This report contains forward-looking statements concerning the company's business, operations, and financial performance - This report contains forward-looking statements concerning the company's business, operations, and financial performance. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially. Readers are cautioned not to place undue reliance on these statements[8](index=8&type=chunk) - Key risks and uncertainties include the ability to raise additional capital, continue as a going concern, the success of clinical trials for the lead product candidate zervimesine (CT1812), regulatory approvals, and competition[8](index=8&type=chunk)[11](index=11&type=chunk) [Part I. Financial Information](index=5&type=section&id=Part%20I.%20Financial%20Information) [Item 1. Financial Statements (unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) Unaudited Q1 2025 financials show a **$8.48 million** net loss and **$16.4 million** cash, raising substantial doubt about going concern [Consolidated Balance Sheets](index=7&type=section&id=Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets decreased to **$23.5 million** from **$30.2 million** at year-end 2024, mainly due to reduced cash Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $16,428 | $25,009 | | Total current assets | $22,866 | $29,555 | | **Total assets** | **$23,500** | **$30,234** | | **Liabilities & Equity** | | | | Total current liabilities | $10,950 | $11,142 | | **Total liabilities** | **$11,230** | **$11,484** | | **Total stockholders' equity** | **$12,270** | **$18,750** | [Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Q1 2025 net loss improved to **$8.48 million** (or **$0.14** per share) from **$9.15 million** in Q1 2024, driven by lower G&A expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Research and development | $10,786 | $10,553 | | General and administrative | $2,989 | $3,549 | | **Total operating expenses** | **$13,775** | **$14,102** | | Grant income | $5,086 | $4,912 | | **Net loss** | **$(8,480)** | **$(9,151)** | | Net loss per share (basic & diluted) | $(0.14) | $(0.27) | [Consolidated Statements of Cash Flows](index=10&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations increased to **$9.9 million** in Q1 2025, while financing cash decreased to **$1.3 million**, resulting in an **$8.6 million** net cash decrease Cash Flow Summary (in thousands) | Cash Flow Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(9,877) | $(7,244) | | Net cash used in investing activities | $0 | $0 | | Net cash provided by financing activities | $1,296 | $11,993 | | **Net (decrease) increase in cash** | **$(8,581)** | **$4,749** | [Notes to Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) Notes detail critical liquidity, with **$16.4 million** cash insufficient for 12 months, raising substantial doubt about going concern - The company's cash and cash equivalents of **$16.4 million** as of March 31, 2025, are not sufficient to fund operations for the next year, which raises substantial doubt about its ability to continue as a going concern[29](index=29&type=chunk)[30](index=30&type=chunk) - During Q1 2025, the company sold **2,004,729 shares** of common stock under its ATM agreement for gross proceeds of approximately **$1.5 million**[27](index=27&type=chunk)[28](index=28&type=chunk) - The company recognized **$5.1 million** in grant income for Q1 2025, primarily from reimbursements from the National Institute of Aging (NIA) for research[37](index=37&type=chunk) - Total equity-based compensation expense was **$0.59 million** in Q1 2025, a decrease from **$1.17 million** in Q1 2024[86](index=86&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance, liquidity, and outlook, highlighting positive Phase 2 data for Alzheimer's and DLB, strategic focus on dementia programs, and urgent need for funding [Overview](index=30&type=section&id=Overview) Cognition Therapeutics, a clinical-stage biopharmaceutical company, focuses on zervimesine for degenerative diseases, reporting positive Phase 2 results for Alzheimer's and DLB, while discontinuing the dAMD study - The Phase 2 SHINE study in mild-to-moderate Alzheimer's Disease met its primary safety endpoints. A prespecified analysis showed that patients with baseline plasma p-tau217 below the median experienced a **95% reduction** in cognitive decline[93](index=93&type=chunk)[94](index=94&type=chunk) - The Phase 2 SHIMMER study in Dementia with Lewy Bodies (DLB) met its primary safety endpoints and demonstrated benefits across behavioral, functional, cognitive, and motor scales compared to placebo[97](index=97&type=chunk)[98](index=98&type=chunk) - The company voluntarily discontinued the Phase 2 MAGNIFY study for geographic atrophy (dAMD) to focus resources on its AD and DLB programs. The decision was not due to safety concerns[99](index=99&type=chunk) [Results of Operations](index=39&type=section&id=Results%20of%20Operations) Q1 2025 total operating expenses decreased to **$13.8 million**, with R&D up slightly and G&A down, contributing to a reduced net loss of **$8.5 million** compared to Q1 2024 Comparison of Operations (in thousands) | Item | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $10,786 | $10,553 | $233 | | General and administrative | $2,989 | $3,549 | $(560) | | **Loss from operations** | **$(13,775)** | **$(14,102)** | **$327** | | Grant income | $5,086 | $4,912 | $174 | | **Net loss** | **$(8,480)** | **$(9,151)** | **$671** | - The **$0.2 million** increase in R&D expenses was primarily driven by a **$0.5 million** rise in clinical program costs for Phase 2 trials, partially offset by a **$0.4 million** decrease in manufacturing costs[121](index=121&type=chunk) [Liquidity and Capital Resources](index=41&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity is critical, with **$16.4 million** cash as of March 31, 2025, sufficient only into Q4 2025, raising substantial doubt about its ability to continue as a going concern and necessitating additional funding - As of March 31, 2025, the company had **$16.4 million** in cash and cash equivalents[128](index=128&type=chunk) - Management believes existing cash will fund operations into the fourth quarter of 2025, which is not sufficient for the next twelve months from the filing date[128](index=128&type=chunk) - The company has access to additional capital through its ATM program (approx. **$20.4 million** remaining) and the Lincoln Park Purchase Agreement (approx. **$34.8 million** remaining), subject to market conditions and other limitations[126](index=126&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=49&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a 'smaller reporting company,' Cognition Therapeutics is not required to provide the information for this item - The company is exempt from this disclosure requirement due to its status as a 'smaller reporting company'[148](index=148&type=chunk) [Item 4. Controls and Procedures](index=49&type=section&id=Item%204.%20Controls%20and%20Procedures) As of March 31, 2025, management concluded that disclosure controls and procedures, along with internal control over financial reporting, were effective with no material changes - Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2025[149](index=149&type=chunk) - There were no changes in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[152](index=152&type=chunk) [Part II. Other Information](index=52&type=section&id=Part%20II.%20Other%20Information) [Item 1. Legal Proceedings](index=52&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings expected to have a material adverse effect on its business or financial condition - As of the filing date, the company is not aware of any pending legal actions that would have a material adverse effect on its business and operations[156](index=156&type=chunk) [Item 1A. Risk Factors](index=52&type=section&id=Item%201A.%20Risk%20Factors) The company adds a new risk factor concerning potential disruptions at the FDA and other government agencies, which could delay product development and approval - A new risk factor was added regarding potential disruptions to the FDA and other government agencies due to funding issues, personnel changes, or policy shifts[159](index=159&type=chunk) - These disruptions could slow the review and approval of new drugs, negatively impacting the company's business[160](index=160&type=chunk) - Uncertainty surrounding the 2025 U.S. presidential administration change could create new challenges or a more costly environment for therapeutic development[162](index=162&type=chunk)[164](index=164&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=54&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of the company's equity securities during the quarter ended March 31, 2025 - The company reports no unregistered sales of its equity securities during the fiscal quarter[165](index=165&type=chunk) [Item 3. Defaults Upon Senior Securities](index=54&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[167](index=167&type=chunk) [Item 4. Mine Safety Disclosures](index=54&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[168](index=168&type=chunk) [Item 5. Other Information](index=54&type=section&id=Item%205.%20Other%20Information) The company reports no other information for this item - None[169](index=169&type=chunk) [Item 6. Exhibits](index=55&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with Form 10-Q, including certifications from the Principal Executive Officer and Principal Financial Officer - The exhibits include certifications from the CEO and CFO pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act[170](index=170&type=chunk)