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Cognition Therapeutics(CGTX) - 2025 Q1 - Quarterly Report
2025-05-07 11:45
[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)
Cognition Therapeutics(CGTX) - 2025 Q1 - Quarterly Results
2025-05-07 11:36
Exhibit 99.1 Cognition Therapeutics Reports Financial Results for the First Quarter 2025 and Provides Business Update - End-of-Phase 2 meeting with FDA requested for Alzheimer's disease – - Phase 2 results in dementia with Lewy bodies accepted for oral presentation at AAIC – - Two posters at ARVO describe zervimesine's role supporting retinal cell health - Purchase, NY – May 7, 2025 – Cognition Therapeutics, Inc. (the "Company" or "Cognition") (NASDAQ: CGTX), a clinical-stage company developing drugs that t ...
Cognition Therapeutics Reports Financial Results for the First Quarter 2025 and Provides Business Update
Globenewswire· 2025-05-07 11:30
- End-of-Phase 2 meeting with FDA requested for Alzheimer’s disease - - Phase 2 results in dementia with Lewy bodies accepted for oral presentation at AAIC - - Two posters at ARVO describe zervimesine's role supporting retinal cell health - PURCHASE, N.Y., May 07, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (the “Company” or “Cognition”) (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, today reported financial results for the first quarter ended Ma ...
Cognition Therapeutics Presents Results at AD/PD 2025 Showing Impact of Zervimesine (CT1812) on Alzheimer's Disease Processes
Newsfilter· 2025-04-01 11:30
PURCHASE, N.Y., April 01, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the "Company" or "Cognition") (NASDAQ:CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, presented biomarker results from the Phase 2 SHINE (COG0201) study of zervimesine (CT1812) in mild-to-moderate Alzheimer's disease at the AD/PD™ 2025 Alzheimer's & Parkinson's Diseases Conference taking place April 1-5, 2025 in Vienna, Austria. Details of Cognition's presentation are as follows: | Posi ...
Cognition Therapeutics Presents Results at AD/PD 2025 Showing Impact of Zervimesine (CT1812) on Alzheimer's Disease Processes
GlobeNewswire News Room· 2025-04-01 11:30
PURCHASE, N.Y., April 01, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the "Company" or "Cognition") (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, presented biomarker results from the Phase 2 SHINE (COG0201) study of zervimesine (CT1812) in mild-to-moderate Alzheimer's disease at the AD/PD™ 2025 Alzheimer's & Parkinson's Diseases Conference taking place April 1-5, 2025 in Vienna, Austria. In her presentation, Mary Hamby, Ph.D., VP of research at ...
Cognition Therapeutics to Report Biomarker Results from Phase 2 SHINE Study in Mild-to-Moderate Alzheimer's Disease in Podium Presentation at AD/PD 2025
Newsfilter· 2025-03-25 11:30
PURCHASE, N.Y., March 25, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the "Company" or "Cognition") (NASDAQ:CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, will be presenting biomarker results from the Phase 2 SHINE (COG0201) study of zervimesine (CT1812) in mild-to-moderate Alzheimer's disease at the AD/PD™ 2025 Alzheimer's & Parkinson's Diseases Conference taking place April 1-5, 2025 in Vienna, Austria. Mary Hamby, Ph.D., Cognition Therapeutics' VP of ...
Cognition Therapeutics to Report Biomarker Results from Phase 2 SHINE Study in Mild-to-Moderate Alzheimer’s Disease in Podium Presentation at AD/PD 2025
Globenewswire· 2025-03-25 11:30
Additional Analyses to be Presented at AD/PD Include Correlation of CSF Biomarkers with Cognitive Outcomes, and Pharmacodynamic Biomarkers of Target EngagementPURCHASE, N.Y., March 25, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the “Company” or “Cognition”) (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, will be presenting biomarker results from the Phase 2 SHINE (COG0201) study of zervimesine (CT1812) in mild-to-moderate Alzheimer’s disease at ...
Cognition Therapeutics(CGTX) - 2024 Q4 - Earnings Call Transcript
2025-03-20 17:15
Cognition Therapeutics, Inc (NASDAQ:CGTX) Q4 2024 Results Conference Call March 20, 2025 8:00 AM ET Company Participants Mike Moyer - LifeSci Advisors Lisa Ricciardi - Chief Executive Officer John Doyle - Chief Financial Officer Anthony Caggiano - Chief Medical Officer, Head of R&D Conference Call Participants Mayank Mamtani - B. Riley Securities Daniil Gataulin - Chardan Operator Greetings, and welcome to the Cognition Therapeutics Fourth Quarter and Full Year 2024 Earnings Call. [Operator Instructions] As ...
Cognition Therapeutics(CGTX) - 2024 Q4 - Earnings Call Transcript
2025-03-20 20:11
Cognition Therapeutics (CGTX) Q4 2024 Earnings Call March 20, 2025 04:11 PM ET Company Participants Mike Moyer - Managing DirectorLisa Ricciardi - President and Chief Executive OfficerJohn Doyle - Chief Financial OfficerMayank Mamtani - Senior Managing DirectorAnthony Caggiano - Chief Medical Officer and Head of R&DRaghuram Selvaraju - Managing Director, Healthcare Equity Research Conference Call Participants Daniil Gataulin - Senior Research Analyst Operator Welcome to the Cognition Therapeutics Fourth Qua ...
Cognition Therapeutics(CGTX) - 2024 Q4 - Annual Report
2025-03-20 11:15
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 ...