[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]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For The Transition Period From To Commission file number: 001-40886 COGNITION THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 13-4365359 (State of Other ...

2025 Objective: Advance Zervimesine into Late-stage Trials for DLB and Alzheimer's Disease Management will Review Results at 8:00 a.m. ET on Live Webcast and Conference Call Exhibit 99.1 Cognition Therapeutics Reports Year End 2024 Financial Results and Provides Business Update Positive Results with Zervimesine (CT1812) in Phase 2 SHIMMER Dementia with Lewy Bodies (DLB) Phase 2 SHINE Data Show Dramatic Slowing of Cognitive Decline with Zervimesine in a Key Pre-specified Alzheimer's Disease Subgroup Purchase ...