[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)

[Introduction and First Quarter 2025 Overview](index=1&type=section&id=Introduction%20and%20First%20Quarter%202025%20Overview) Cognition Therapeutics reported Q1 2025 financial results and business updates, highlighting progress in Alzheimer's disease and dementia with Lewy bodies programs [Executive Summary](index=1&type=section&id=Executive%20Summary) Cognition Therapeutics reported its financial results for the first quarter ended March 31, 2025, and provided a business update, highlighting significant progress in its Alzheimer's disease and dementia with Lewy bodies (DLB) programs - Requested an **End-of-Phase 2 (EOP2) meeting** with the FDA for the Alzheimer's disease program[1](index=1&type=chunk)[6](index=6&type=chunk) - **Phase 2 results** in dementia with Lewy bodies (DLB) accepted for **oral presentation** at the **Alzheimer's Association International Congress (AAIC)**[1](index=1&type=chunk)[6](index=6&type=chunk) - **Two posters** at **ARVO** describe **zervimesine's role** in supporting retinal cell health[1](index=1&type=chunk)[6](index=6&type=chunk) [Business and Corporate Highlights](index=1&type=section&id=Business%20and%20Corporate%20Highlights) This section details the company's strategic advancements and key operational achievements in its clinical programs [CEO Commentary and Strategic Progress](index=1&type=section&id=CEO%20Commentary%20and%20Strategic%20Progress) CEO Lisa Ricciardi highlighted the continued advancement of the company's Alzheimer's disease and DLB programs, including a formal request for an EOP2 meeting with the FDA for Alzheimer's and the initiation of a commercial IND application for zervimesine in DLB to facilitate a separate EOP2 meeting - A request was made with the U.S. Food and Drug Administration to schedule an **EOP2 meeting** to review **SHINE study results** in Alzheimer's disease and discuss plans for a registrational study[2](index=2&type=chunk)[6](index=6&type=chunk) - Initiated the process of securing a **commercial investigational new drug (IND) application** for **zervimesine (CT1812)** in **DLB** to enable a separate **EOP2 meeting** for this indication[2](index=2&type=chunk) [Key Operational Achievements](index=1&type=section&id=Key%20Operational%20Achievements) Cognition Therapeutics achieved several key operational milestones, including the acceptance of Phase 2 SHIMMER study results for an oral presentation at AAIC and presentations at ARVO and ILBDC - **Phase 2 'SHIMMER' study results** in DLB were accepted for a **podium presentation** at the **Alzheimer's Association International Congress (AAIC)**, scheduled for July 27-31, 2025[6](index=6&type=chunk) - Presented **two posters** at the **Association for Research in Vision and Ophthalmology (ARVO)** meeting, describing **zervimesine's role** in regulating lipid metabolism and protecting retinal cells[6](index=6&type=chunk) - Results from the Company's **Phase 2 'SHIMMER' study** were presented at the **International Lewy Body Dementia Conference (ILBDC)** in January 2025[6](index=6&type=chunk) [First Quarter 2025 Financial Results](index=1&type=section&id=First%20Quarter%202025%20Financial%20Results) This section provides an overview of the company's financial performance for the first quarter of 2025, including liquidity, operating expenses, and net loss [Liquidity and Cash Position](index=1&type=section&id=Liquidity%20and%20Cash%20Position) As of March 31, 2025, Cognition Therapeutics reported its cash and cash equivalents, along with remaining obligated grant funds, and provided an estimate for its cash runway **Cash and Grant Funds (as of March 31, 2025):** | Metric | Amount (Millions) | | :--------------------- | :---------------- | | Cash and cash equivalents | $16.4 | | Obligated grant funds | $47.0 | - The Company estimates that it has **sufficient cash** to fund operations and capital expenditures into the **fourth quarter of 2025**[4](index=4&type=chunk) [Operating Expenses Analysis](index=1&type=section&id=Operating%20Expenses%20Analysis) Research and development (R&D) expenses saw a slight increase, primarily driven by Phase 2 trial activities, while general and administrative (G&A) expenses decreased due to lower stock compensation **Operating Expenses (Three Months Ended March 31):** | Expense Category | Q1 2025 (Millions) | Q1 2024 (Millions) | Change (YoY) | Primary Driver | | :------------------- | :----------------- | :----------------- | :----------- | :------------- | | Research and development | $10.8 | $10.6 | +$0.2 | Increased Phase 2 trial activities | | General and administrative | $3.0 | $3.5 | -$0.5 | Lower stock compensation | [Net Loss and Per Share Data](index=2&type=section&id=Net%20Loss%20and%20Per%20Share%20Data) The company reported a reduced net loss and improved net loss per share for the first quarter of 2025 compared to the prior year period **Net Loss and EPS (Three Months Ended March 31):** | Metric | Q1 2025 | Q1 2024 | Change (YoY) | | :------------------- | :------ | :------ | :----------- | | Net loss | $(8.5) million | $(9.2) million | -$0.7 million | | Net loss per share (Basic & Diluted) | $(0.14) | $(0.27) | +$0.13 | [Consolidated Financial Statements](index=3&type=section&id=Consolidated%20Financial%20Statements) This section presents the detailed consolidated financial statements, including statements of operations and balance sheet data [Consolidated Statements of Operations](index=3&type=section&id=Consolidated%20Statements%20of%20Operations%20Data) The consolidated statements of operations provide a detailed breakdown of the company's revenues, expenses, and net loss for the three months ended March 31, 2025, and 2024 **Consolidated Statements of Operations Data (in thousands, except share and per share data amounts):** | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------------------------------ | :-------------------------------- | :-------------------------------- | | **Operating Expenses:** | | | | Research and development | $10,786 | $10,553 | | General and administrative | 2,989 | 3,549 | | Total operating expenses | 13,775 | 14,102 | | Loss from operations | (13,775) | (14,102) | | **Other income (expense):** | | | | Grant income | 5,086 | 4,912 | | Other income, net | 214 | 244 | | Interest expense | (5) | (10) | | Loss on currency translation from liquidation of subsidiary | — | (195) | | Total other income, net | 5,295 | 4,951 | | **Net loss** | **$(8,480)** | **$(9,151)** | | Foreign currency translation adjustment, including reclassifications | — | 195 | | Total comprehensive loss | $(8,480) | $(8,956) | | **Net loss per share:** | | | | Basic | $(0.14) | $(0.27) | | Diluted | $(0.14) | $(0.27) | | **Weighted-average common shares outstanding:** | | | | Basic | 61,828,149 | 33,735,269 | | Diluted | 61,828,149 | 33,735,269 | [Consolidated Balance Sheet Data](index=3&type=section&id=Consolidated%20Balance%20Sheet%20Data) The consolidated balance sheet data presents the company's financial position, including assets, liabilities, and equity, as of March 31, 2025, compared to December 31, 2024 **Consolidated Balance Sheet Data (in thousands):** | Metric | As of March 31, 2025 | As of December 31, 2024 | | :----------------------- | :------------------- | :--------------------- | | Cash and cash equivalents | $16,428 | $25,009 | | Total assets | 23,500 | 30,234 | | Total liabilities | 11,230 | 11,484 | | Accumulated deficit | (183,640) | (175,160) | | Total stockholders' equity | 12,270 | 18,750 | [About Cognition Therapeutics, Inc.](index=2&type=section&id=About%20Cognition%20Therapeutics%2C%20Inc.) This section provides an overview of Cognition Therapeutics, a clinical-stage biopharmaceutical company focused on neurodegenerative disorders [Company Profile and Therapeutic Focus](index=2&type=section&id=Company%20Profile%20and%20Therapeutic%20Focus) Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative small molecule therapeutics for age-related neurodegenerative disorders, with its lead candidate zervimesine (CT1812) targeting DLB and Alzheimer's disease - Cognition Therapeutics is a **clinical-stage biopharmaceutical company** discovering and developing innovative, **small molecule therapeutics** targeting **age-related degenerative disorders** of the central nervous system[9](index=9&type=chunk) - The **lead candidate, zervimesine (CT1812)**, is currently being investigated in clinical programs for **dementia with Lewy bodies (DLB)** and **Alzheimer's disease**[9](index=9&type=chunk) - Zervimesine is believed to regulate pathways impaired in these diseases through its interaction with the **sigma-2 receptor**, a functionally distinct mechanism[9](index=9&type=chunk) [Forward-Looking Statements](index=2&type=section&id=Forward-Looking%20Statements) This section contains a standard legal disclaimer regarding forward-looking statements and associated risks [Disclaimer](index=2&type=section&id=Disclaimer) This section contains a standard legal disclaimer, emphasizing that the press release includes forward-looking statements that are subject to various risks, uncertainties, and factors that could cause actual results to differ materially from those projected - This press release contains **forward-looking statements** regarding cash runway, clinical studies of zervimesine, expected benefits, clinical development plans, and regulatory approval[10](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 projections[10](index=10&type=chunk) - The company **does not plan to publicly update or revise** any forward-looking statements contained herein, except as required by applicable law[10](index=10&type=chunk) [Contact Information](index=3&type=section&id=Contact%20Information) This section provides contact details for investor and media inquiries [Investor and Media Relations](index=3&type=section&id=Investor%20and%20Media%20Relations) Contact details are provided for media and investor inquiries regarding Cognition Therapeutics - Contact information for **media inquiries** (Casey McDonald at Tiberend Strategic Advisors) and **investor inquiries** (Mike Moyer at LifeSci Advisors) is provided[11](index=11&type=chunk)

Core Insights - Cognition Therapeutics is advancing its Alzheimer's disease and dementia with Lewy bodies (DLB) programs, requesting an end-of-Phase 2 meeting with the FDA to discuss the SHINE study results and plans for a registrational study [2][9] - The company reported a net loss of $8.5 million for Q1 2025, an improvement from a net loss of $9.2 million in Q1 2024, with a loss per share of $(0.14) compared to $(0.27) in the prior year [7][13] - Cash and cash equivalents as of March 31, 2025, were approximately $16.4 million, with total obligated grant funds remaining at $47.0 million, indicating sufficient cash to fund operations into Q4 2025 [4][12] Business and Corporate Highlights - The Phase 2 results in DLB were accepted for oral presentation at the Alzheimer's Association International Congress (AAIC) scheduled for July 27-31, 2025 [9] - Two posters will be presented at the Association for Research in Vision and Ophthalmology (ARVO) meeting, highlighting zervimesine's role in retinal cell health [9] - The company is in the process of securing a commercial investigational new drug (IND) application for zervimesine in DLB to facilitate separate EOP2 meetings for each indication [2] Financial Results - Research and development expenses for Q1 2025 were $10.8 million, slightly up from $10.6 million in Q1 2024, primarily due to increased Phase 2 trial activities [5] - General and administrative expenses decreased to $3.0 million in Q1 2025 from $3.5 million in Q1 2024, attributed to lower stock compensation [6] - Total operating expenses for Q1 2025 were $13.775 million, down from $14.102 million in the same period of 2024 [12]

Core Insights - Cognition Therapeutics, Inc. presented biomarker results from the Phase 2 SHINE study of zervimesine (CT1812) for mild-to-moderate Alzheimer's disease at the AD/PD 2025 Conference [1] - The study focused on changes in biomarkers, particularly in a subgroup with lower levels of p-Tau217, which is indicative of Alzheimer's pathology [2] Study Findings - Participants receiving zervimesine for six months showed reductions in plasma biomarkers associated with Alzheimer's compared to placebo [3] - Significant reductions were noted in glial fibrillary acidic protein (GFAP) and neurofilament light (NfL), both linked to neuroinflammation and neurodegeneration, respectively [4] - The low-p-Tau217 subgroup exhibited more pronounced reductions in biomarkers, correlating with cognitive improvements observed in this group [5] Presentation Details - The presentation included multiple studies highlighting the positive impact of CT1812 on plasma biomarkers and cognitive outcomes in Alzheimer's patients [5] - Key authors of the studies presented include Mary Hamby, Ph.D., and others, with presentations scheduled at various locations during the conference [5] Company Overview - Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapeutics for neurodegenerative disorders, with zervimesine as a lead candidate [6] - The company is exploring zervimesine's mechanism of action through its interaction with the sigma-2 receptor, which is distinct from other treatment approaches [6]

Core Insights - Cognition Therapeutics, Inc. presented biomarker results from the Phase 2 SHINE study of zervimesine (CT1812) for mild-to-moderate Alzheimer's disease at the AD/PD 2025 Conference [1][2] Group 1: Study Findings - The study analyzed changes in biomarkers, particularly focusing on participants with lower levels of p-Tau217, a protein indicative of Alzheimer's pathology [2][3] - Participants treated with zervimesine showed reductions in plasma biomarkers associated with Alzheimer's compared to placebo, with the low-p-Tau217 subgroup experiencing more pronounced reductions [3][4] - Significant reductions were noted in glial fibrillary acidic protein (GFAP) and neurofilament light (NfL), both associated with neuroinflammation and neurodegeneration, respectively [4][5] Group 2: Presentation Details - The presentation titled "Positive Impact of CT1812 Treatment on Plasma Biomarkers in Lower p-tau217 Subgroup Aligns with Clinical Benefits in Mild-to-Moderate AD Patients" was delivered by Dr. Mary Hamby on April 1, 2025 [5] - Additional presentations included analyses of CSF proteomic biomarkers and molecular correlates related to cognitive outcomes in participants of the SHINE study [5] Group 3: Company Overview - Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapeutics for age-related neurodegenerative disorders, with zervimesine being the lead candidate [6] - The company is also investigating zervimesine in other clinical programs, including dementia with Lewy bodies [6]

Core Insights - Cognition Therapeutics, Inc. is set to present biomarker results from the Phase 2 SHINE study of zervimesine (CT1812) for mild-to-moderate Alzheimer's disease at the AD/PD 2025 Conference in Vienna, Austria from April 1-5, 2025 [1] - The presentation will focus on key proteins, or biomarkers, collected from blood samples, including neurofilament light (NfL) chain, glial fibrillary acidic protein (GFAP), amyloid beta (Aβ), and tau species (p-Tau217 and p-Tau218), which are associated with Alzheimer's disease progression [2] 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 [4] - The company is currently investigating zervimesine (CT1812) in clinical programs for dementia with Lewy bodies and Alzheimer's disease, including the ongoing START study in early Alzheimer's disease [4] - Zervimesine is believed to regulate impaired pathways in these diseases through its interaction with the sigma-2 receptor, which represents a distinct mechanism from other treatment approaches [4] Presentation Details - Dr. Mary Hamby will present findings from the SHINE study, highlighting the impact of zervimesine on disease biology through biomarker changes compared to placebo [3] - The presentation will include several key topics: 1. Positive impact of CT1812 treatment on plasma biomarkers in a lower p-tau217 subgroup [3] 2. CSF proteomic biomarker analysis identifying effects of CT1812 in Alzheimer's disease [3] 3. Identification of CSF proteins correlating with cognitive outcomes in the SHINE study participants [3] 4. Molecular correlates with CT1812 treatment-related decrease in NfL CSF levels [3]

Core Insights - Cognition Therapeutics, Inc. will present biomarker results from the Phase 2 SHINE study of zervimesine (CT1812) for Alzheimer's disease at the AD/PD 2025 Conference [1] - The study focuses on key proteins, or biomarkers, associated with Alzheimer's disease progression, including neurofilament light (NfL), glial fibrillary acidic protein (GFAP), amyloid beta (Aβ), and tau species [2] - The analysis aims to provide insights into the impact of zervimesine on disease biology by comparing biomarker changes in participants receiving the drug versus those on placebo [3] Presentation Details - The podium presentation titled "Positive Impact of CT1812 Treatment on Plasma Biomarkers in Lower p-tau217 Subgroup Aligns with Clinical Benefits in Mild-to-Moderate AD Patients" is scheduled for April 1, 2025, at 2:45 PM CET [4] - Additional poster presentations will cover CSF proteomic biomarker analysis, identification of CSF proteins correlating with cognitive outcomes, and molecular correlates with treatment-related decreases in NfL CSF levels [4] Company Overview - Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related neurodegenerative disorders [5] - The lead candidate, zervimesine (CT1812), is being investigated in clinical programs for dementia with Lewy bodies and Alzheimer's disease, including the ongoing START study [5] - The company believes zervimesine can regulate impaired pathways in these diseases through its interaction with the sigma-2 receptor, which is distinct from other treatment approaches [5]

Financial Data and Key Metrics Changes - The company reported a net loss of $34 million or $0.86 per basic and diluted share for the year ended December 31, 2024, compared to a net loss of $25.8 million or $0.86 per basic and diluted share for 2023 [23] - Cash and cash equivalents as of December 31, 2024, were approximately $25 million, with total obligated grant funds remaining from the NIA at $50 million [20] - Research and development expenses increased to $41.7 million for the year ended December 31, 2024, from $37.2 million in 2023, primarily due to higher costs associated with completing two Phase II trials [21] Business Line Data and Key Metrics Changes - The company decided to conclude its Phase II dry AMD study before completion, reallocating resources entirely to Alzheimer's and DLB programs [11][19] - The decision to conclude the dry AMD study was based on prioritizing the success of the Alzheimer's and DLB programs, despite showing potential efficacy in dry AMD [12][13] Market Data and Key Metrics Changes - The company is actively pursuing partnerships for funding and development in the Alzheimer's and DLB space, indicating strong interest from biotech and pharma players [15] - The company has received a 6-month grace period to regain compliance with NASDAQ's minimum bid requirement, needing to maintain a stock price above $1 for 10 consecutive days before September 8, 2025 [24] Company Strategy and Development Direction - The focus remains on advancing zervimesine for Alzheimer's disease and dementia with Lewy bodies, with plans to submit final study documents to the FDA for two different end of Phase II meetings [9][10] - The company is preparing for Phase III readiness and has developed a novel chemical process for zervimesine manufacturing, with provisional patent applications filed [17][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in regaining NASDAQ compliance and highlighted upcoming milestones that could drive stock value [24] - The company is committed to addressing financing challenges while aiming to deliver multiple clinical milestones and create long-term shareholder value [60] Other Important Information - The company has built strong relationships with potential partners and is evaluating all options for financing clinical development efforts [15][16] - The publication process for SHIMMER data is underway, with expectations for release in the coming months [37] Q&A Session Summary Question: Thoughts on tau cutoff threshold for Phase II FDA meeting - Management plans to enrich participants in the next study for those with lower tau, similar to the SHINE study, but has not finalized the specific cutoff [29][30] Question: Feedback from investigative physicians on SHIMMER data - Management received excellent feedback from KOLs and payers, indicating a strong need for zervimesine and appreciation for its safety profile [35] Question: Competitive landscape in DLB and potential approvability - Management is confident that neuropsychiatric symptoms will be of interest to physicians and the FDA, with a focus on determining appropriate outcome measures for studies [49][50] Question: Outlook for accelerated approval in Europe vs. the US - The company plans to follow a traditional pathway for Phase III studies, as the accelerated approval process has been complex and not necessarily easier in Europe [52][53] Question: NIH funding outlook and potential for new grants - The company has a remaining balance of $50 million from NIH funding, which is expected to support ongoing trials, but anticipates lower probability for new grant funding as it progresses to Phase III [54][56]

Financial Data and Key Metrics Changes - The company reported a net loss of $34 million or $0.86 per basic and diluted share for the year ended December 31, 2024, compared to a net loss of $25.8 million or $0.86 per basic and diluted share for 2023 [23] - Cash and cash equivalents as of December 31, 2024, were approximately $25 million, with total obligated grant funds remaining from the NIA at $50 million [20][21] - Research and development expenses increased to $41.7 million for the year ended December 31, 2024, from $37.2 million for 2023, primarily due to higher costs associated with completing two Phase II trials [22] Business Line Data and Key Metrics Changes - The company decided to conclude its Phase II dry AMD study before completion, reallocating resources entirely to Alzheimer's and DLB programs [11][19] - The decision to conclude the dry AMD study was based on strategic prioritization rather than safety concerns, as the analysis indicated potential efficacy [12][13] Market Data and Key Metrics Changes - The company is actively pursuing partnerships for funding and development in the Alzheimer's and DLB space, indicating strong interest from biotech and pharma players [15][35] - The company received a 6-month grace period to regain compliance with NASDAQ's minimum bid requirement, needing to maintain a stock price above $1 for 10 consecutive days before September 8, 2025 [24] Company Strategy and Development Direction - The focus remains on advancing zervimesine for Alzheimer's disease and DLB, with plans to submit final study documents to the FDA for two different end of Phase II meetings [10][14] - The company is preparing for Phase III readiness and has developed a novel chemical process for zervimesine manufacturing, with provisional patent applications filed [17][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in regaining NASDAQ compliance and highlighted upcoming milestones that could drive stock value [24][60] - The company is committed to overcoming financing challenges and is focused on delivering multiple clinical milestones to create long-term shareholder value [60] Other Important Information - The company has built strong relationships with potential partners and is evaluating all options for financing clinical development efforts [15][16] - The publication process for SHIMMER data is underway, with expectations for release in the coming months [37] Q&A Session Summary Question: Thoughts on tau cutoff threshold for end of Phase II FDA meeting - Management plans to enrich participants in the next study for those with lower tau, similar to the SHINE study, but has not finalized the specific cutoff [29][30] Question: Feedback from investigative physicians on SHIMMER data - Management received excellent feedback from KOLs and neurologists, indicating a strong need for zervimesine and appreciation for its safety profile [35] Question: Competitive landscape in DLB and potential approvability - Management is confident that neuropsychiatric symptoms will be of interest to the FDA, and they plan to propose specific outcome measures during the FDA meeting [49][50] Question: Outlook for accelerated approval in Europe vs. the US - The company plans to follow a traditional pathway for approval, as the accelerated pathway has shown mixed results in the past [52] Question: NIH funding outlook and potential for new grants - The company has a remaining balance of $50 million from NIH funding, which is expected to support ongoing trials, but anticipates lower probability for new grant funding as it progresses to Phase III [54][56]

Financial Performance - The company incurred net losses of $34.0 million and $25.8 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $175.2 million as of December 31, 2024[204]. - The company has $25.0 million in cash and cash equivalents as of December 31, 2024, and expects this to fund operations into the fourth quarter of 2025[219]. - The company anticipates significant increases in expenses related to ongoing and planned clinical trials, regulatory compliance, and commercialization efforts[205]. - The company acknowledges substantial doubt about its ability to continue as a going concern without raising additional capital[211]. - Current capital market conditions have increased borrowing rates, significantly raising the company's cost of capital compared to prior periods[224]. Capital Raising and Financing - The company plans to raise additional capital through public or private equity offerings, debt financings, and collaborations, but there is no assurance that such financing will be available[211]. - The company has entered into a Purchase Agreement with Lincoln Park for the sale of up to $35 million worth of shares and a sales agreement for up to $40 million in "at-the-market" offerings[222]. - The company has partially relied on non-dilutive NIA Grants to cover capital requirements for clinical trials, but future funding is uncertain[225]. - The company’s ability to raise additional capital on acceptable terms is critical for its operations and may be adversely affected by market conditions[235]. Product Development and Clinical Trials - The company is focused on the development of zervimesine for treating mild-to-moderate Alzheimer's disease, Parkinson's disease, and other age-related degenerative diseases[205]. - The company has completed Phase 2 clinical trials but lacks a history of commercializing products, which may affect investor confidence[216]. - The company may face significant delays or inability to obtain regulatory approvals for its product candidates, impacting commercialization efforts[239]. - Clinical trials are expensive and can take many years to complete, with outcomes being inherently uncertain, potentially delaying or preventing marketing approval[246]. - The company may encounter substantial delays in preclinical studies and clinical trials due to various factors, including supply chain disruptions and regulatory disagreements[247]. Regulatory and Compliance Risks - The company has received a deficiency letter from Nasdaq regarding its stock price falling below the minimum requirement of $1.00 per share[212]. - The company may face delisting from Nasdaq if it does not regain compliance with listing standards by September 8, 2025[213]. - The company is subject to audits related to NIA Grants, which could require repayment of funds if expenditures are found unallowable[227]. - The company is subject to extensive regulations regarding drug products, and failure to obtain necessary approvals could inhibit commercialization efforts[280]. - Compliance with health and data protection laws is essential, as violations could lead to significant penalties and adversely affect business operations[296]. Intellectual Property and Patent Risks - Patent protection is critical for competitive advantage; failure to secure patents could hinder product commercialization[307]. - The patent prosecution process is expensive and may not guarantee meaningful protection for product candidates[309]. - The company may face challenges in protecting its intellectual property rights globally, particularly in developing countries where patent enforcement is weaker[316]. - The company may need to license third-party intellectual property, which may not be available on commercially reasonable terms, impacting its business[331]. - The company cannot guarantee the successful identification or interpretation of relevant third-party patents, which could negatively impact its ability to develop and market products[340]. Market and Competitive Landscape - The competitive landscape includes major pharmaceutical companies with significant resources, which may impact the company's ability to successfully market its products[377]. - The market opportunities for the product candidate zervimesine may be smaller than anticipated, potentially hindering revenue generation and profitability[367]. - The company may face challenges in obtaining adequate coverage and reimbursement for its product candidates, which is essential for commercialization[381]. - Third-party payors may challenge prices and coverage for the company's products, potentially limiting financial returns on investments[383]. Operational and Organizational Challenges - As of March 1, 2025, the company had 25 full-time and 3 part-time employees, indicating a need for organizational expansion to manage operations and clinical trials effectively[281]. - Attracting and retaining qualified personnel is critical, as the loss of key management or scientific personnel could delay product development and commercialization efforts[284]. - The company faces risks in managing future growth, which may divert financial and other resources from day-to-day activities[282]. - The company currently lacks a sales organization, which may hinder effective marketing and revenue generation for approved product candidates[388]. Cybersecurity and Compliance Costs - Cybersecurity incidents pose significant risks, as disruptions or breaches could materially affect business operations and financial condition[291]. - The California Consumer Privacy Act (CCPA) may increase compliance costs and potential liability for the company, impacting business activities[298]. - Companies face potential fines for noncompliance with GDPR of up to €20 million or 4% of annual global revenue, whichever is greater[299]. - Compliance with U.S. and foreign data protection laws may lead to increased operational costs and restrictions on data handling[300]. Environmental, Social, and Governance (ESG) Considerations - Environmental, social, and governance (ESG) compliance may increase general and administrative expenses and management attention[304]. - Developing ESG initiatives can be costly and time-consuming, with potential reputational risks if goals are not met[305].