CGTX
Cognition TherapeuticsDDocument history
Earnings documents stored for CGTX.
Investor releaseQuarter not tagged2026-08-06Cognition Therapeutics Reports Financial Results for the Second Quarter 2026 and Provides Business Update
GlobeNewswire
Cognition Therapeutics Reports Financial Results for the Second Quarter 2026 and Provides Business Update
PURCHASE, N.Y., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (NASDAQ: CGTX), a clinical-stage company developing product candidates that treat neurodegenerative disorders (the “Company” or “Cognition”), today reported financial results for the second quarter ended June 30, 2026, and provided a business update. “The second quarter marked important progress across both our clinical and corporate priorities,” said Lisa Ricciardi, Cognition’s president and CEO. “Discussions with the Food and Drug Administration (FDA) brought clarity on key aspects of our planned Phase 3 trial for people with dementia with Lewy bodies (DLB) who experience psychosis (DLB psychosis). We are focused on initiating our Phase 3 study in mid-2027 with an improved tablet composition. In addition, the allowance of a new composition of matter patent meaningfully extends our intellectual property coverage for zervimesine and reinforces the long-term value of our pipeline.” Business and Corporate Highlights Conducted a planned meeting with the FDA to discuss the design of a registrational study in DLB psychosis; Company to provide update on timing after alignment on endpoints Received a Notice of Allowance for a patent application covering composition of matter, production process, and therapeutic method of treating Alzheimer’s disease and DLB with a polymorphic crystalline form of zervimesine. Once issued, the patent would extend protection through 2045 before patent-term extension Extended the ongoing expanded access program for zervimesine in DLB through 2027 with funding from a second philanthropic donor Presented a poster at the Alzheimer’s Association International Convention (AAIC) outlining a proposed Phase 3 study design for zervimesine in DLB psychosis. Second Quarter 2026 Financial Results Cash, cash equivalents, and restricted cash equivalents as of June 30, 2026 were approximately $34.8 million, and total obligated grant funds remaining from the National Institute of Aging, a division of the National Institute of Health were $21.6 million. The Company estimates that it has sufficient cash to fund operations and capital expenditures into the fourth quarter of 2027. Research and development expenses were $5.1 million for the quarter ended June 30, 2026, compared to $11.5 million for the comparable period in 2025. The decrease in research and development expenses…Read full documentShow less
PURCHASE, N.Y., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (NASDAQ: CGTX), a clinical-stage company developing product candidates that treat neurodegenerative disorders (the “Company” or “Cognition”), today reported financial results for the second quarter ended June 30, 2026, and provided a business update. “The second quarter marked important progress across both our clinical and corporate priorities,” said Lisa Ricciardi, Cognition’s president and CEO. “Discussions with the Food and Drug Administration (FDA) brought clarity on key aspects of our planned Phase 3 trial for people with dementia with Lewy bodies (DLB) who experience psychosis (DLB psychosis). We are focused on initiating our Phase 3 study in mid-2027 with an improved tablet composition. In addition, the allowance of a new composition of matter patent meaningfully extends our intellectual property coverage for zervimesine and reinforces the long-term value of our pipeline.” Business and Corporate Highlights Conducted a planned meeting with the FDA to discuss the design of a registrational study in DLB psychosis; Company to provide update on timing after alignment on endpoints Received a Notice of Allowance for a patent application covering composition of matter, production process, and therapeutic method of treating Alzheimer’s disease and DLB with a polymorphic crystalline form of zervimesine. Once issued, the patent would extend protection through 2045 before patent-term extension Extended the ongoing expanded access program for zervimesine in DLB through 2027 with funding from a second philanthropic donor Presented a poster at the Alzheimer’s Association International Convention (AAIC) outlining a proposed Phase 3 study design for zervimesine in DLB psychosis. Second Quarter 2026 Financial Results Cash, cash equivalents, and restricted cash equivalents as of June 30, 2026 were approximately $34.8 million, and total obligated grant funds remaining from the National Institute of Aging, a division of the National Institute of Health were $21.6 million. The Company estimates that it has sufficient cash to fund operations and capital expenditures into the fourth quarter of 2027. Research and development expenses were $5.1 million for the quarter ended June 30, 2026, compared to $11.5 million for the comparable period in 2025. The decrease in research and development expenses was driven by lower trial activities with contract research organizations, compensation and professional fees. General and administrative expenses were $2.6 million for the quarter ended June 30, 2026, compared to $2.5 million for the comparable period in 2025. The increase in general and administrative expenses was driven primarily by higher professional fees. The Company reported a net loss of $3.9 million, or $(0.04) per basic and diluted share for the second quarter ended June 30, 2026, compared to a net loss of $6.7 million, or $(0.11) per basic and diluted share for the same period in 2025. About Cognition Therapeutics Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to helping millions of families seeking effective treatments for devastating neurodegenerative diseases through the development of novel, accessible therapies. The company has led pioneering research into the underlying mechanisms of degenerative nerve disorders. Our scientific approach builds on well-established biological pathways and translates across indications in which toxic oligomers drive disease progression, offering potential in dementia with Lewy bodies (DLB), Alzheimer’s disease, geographic atrophy, Parkinson’s, among others. The company’s lead candidate, zervimesine (CT1812), is an investigational once-daily oral therapy that has demonstrated promise in Phase 2 clinical trials in DLB and mild-to-moderate Alzheimer’s disease. Backed by nearly $200 million in National Institutes of Health and related foundation grants, Cognition Therapeutics continues to advance clinical research in its efforts to bring forth solutions that meet patients where they are and reduce caregiver burden. Learn more at cogrx.com. About Zervimesine (CT1812) Zervimesine (CT1812) is currently being studied in the Phase 2 START Study (NCT05531656) in patients with MCI and early Alzheimer’s disease. Phase 2 clinical studies have been completed in dementia with Lewy bodies (DLB), mild-to-moderate Alzheimer’s disease, and geographic atrophy secondary to dry AMD. Based in part on the strong efficacy signals observed in the Phase 2 SHIMMER study in DLB (NCT05225415), the company plans to advance zervimesine into a late-stage clinical trial for people with DLB psychosis. Zervimesine has been generally well tolerated in clinical studies to date. The USAN Council has adopted zervimesine as the United States Adopted Name (USAN) for CT1812. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release or made during the conference, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding our product candidates, including zervimesine (CT1812), and any expected or implied benefits or results, including that initial clinical results observed with respect to zervimesine will be replicated in later trials and our clinical development plans, including statements regarding our planned FDA interactions and registrational program for zervimesine, the EAP, and any analyses of the results therefrom, are forward-looking statements. These statements, including statements relating to the timing and expected results of our clinical trials involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: competition; our ability to secure new (and retain existing) grant funding; our ability to grow and manage growth, maintain relationships with suppliers and retain our management and key employees; our ability to successfully advance our current and future product candidates through development activities, preclinical studies and clinical trials and costs related thereto; uncertainties inherent in the results of preliminary data, pre-clinical studies and earlier-stage clinical trials being predictive of the results of early or later-stage clinical trials; the timing, scope and likelihood of regulatory filings and approvals, including regulatory approval of our product candidates; changes in applicable laws or regulations; the possibility that the we may be adversely affected by other economic, business or competitive factors, including ongoing economic uncertainty; our estimates of expenses and profitability; the evolution of the markets in which we compete; our ability to implement our strategic initiatives and continue to innovate our existing products; our ability to defend our intellectual property; the impacts of ongoing global and regional conflicts on our business, supply chain and labor force; our ability to maintain the listing of our common stock on the Nasdaq Global Market; and the risks and uncertainties described more fully in the “Risk Factors” section of our annual and quarterly reports filed with the Securities & Exchange Commission and are available at www.sec.gov. These risks are not exhaustive and we face both known and unknown risks. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. This press release was published by a CLEAR® Verified individual.
Investor releaseQuarter not tagged2026-05-08Cognition Therapeutics Reports Financial Results for the First Quarter 2026 and Provides Business Update
GlobeNewswire
Cognition Therapeutics Reports Financial Results for the First Quarter 2026 and Provides Business Update
Meeting with FDA Division of Psychiatry scheduled for May 2026 expected to inform registrational plans for zervimesine in DLB psychosis PURCHASE, N.Y., May 07, 2026 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (NASDAQ: CGTX), clinical-stage company developing product candidates that treat neurodegenerative disorders, (the “Company” or “Cognition”), today reported financial results for the first quarter ended March 31, 2026, and provided a business update. “We filed a request to meet with the Food and Drug Administration’s Division of Psychiatry to discuss our plans for a registrational study in people with dementia with Lewy body (DLB) psychosis,” stated Lisa Ricciardi, Cognition’s president and CEO. “We recently received our meeting invitation for May 20, 2026 and we are looking forward to a productive conversation so we can continue to move zervimesine forward in this important indication. “Looking ahead, we remain committed to developing zervimesine for the treatment of Alzheimer’s disease. Topline results from the 545-participant Phase 2 ‘START’ COG0203 (NCT05531656) study in mild cognitive impairment (MCI) and early Alzheimer's disease are anticipated in 2027. We expect these findings will inform our clinical development plans for Alzheimer’s disease.” Business and Corporate Highlights Requested a meeting with FDA Division of Psychiatry, which is expected to be conducted on May 20 with receipt of meeting minutes anticipated in June. Presented two posters at the AD/PD™ 2026 Alzheimer’s & Parkinson’s Diseases Conference: an analysis of zervimesine’s effect on the components of the neuropsychiatric index, which was used in the Phase 2 COG1201 SHIMMER study (NCT05225415) in participants with DLB; and a proposed composite endpoint containing measures of memory, motor, fluctuations, behavior and psychosis, which may be an effective method of capturing the complexity of DLB symptoms in future clinical trials. First Quarter 2025 Financial Results Cash, cash equivalents, and restricted cash equivalents as of March 31, 2026 were approximately $31.2 million, and total obligated grant funds remaining from the National Institute of Aging, a division of the National Institute of Health were $25.6 million. The Company estimates that it has sufficient cash to fund operations and capital expenditures through the second quarter of 2027. Research and development expen…Read full documentShow less
Meeting with FDA Division of Psychiatry scheduled for May 2026 expected to inform registrational plans for zervimesine in DLB psychosis PURCHASE, N.Y., May 07, 2026 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (NASDAQ: CGTX), clinical-stage company developing product candidates that treat neurodegenerative disorders, (the “Company” or “Cognition”), today reported financial results for the first quarter ended March 31, 2026, and provided a business update. “We filed a request to meet with the Food and Drug Administration’s Division of Psychiatry to discuss our plans for a registrational study in people with dementia with Lewy body (DLB) psychosis,” stated Lisa Ricciardi, Cognition’s president and CEO. “We recently received our meeting invitation for May 20, 2026 and we are looking forward to a productive conversation so we can continue to move zervimesine forward in this important indication. “Looking ahead, we remain committed to developing zervimesine for the treatment of Alzheimer’s disease. Topline results from the 545-participant Phase 2 ‘START’ COG0203 (NCT05531656) study in mild cognitive impairment (MCI) and early Alzheimer's disease are anticipated in 2027. We expect these findings will inform our clinical development plans for Alzheimer’s disease.” Business and Corporate Highlights Requested a meeting with FDA Division of Psychiatry, which is expected to be conducted on May 20 with receipt of meeting minutes anticipated in June. Presented two posters at the AD/PD™ 2026 Alzheimer’s & Parkinson’s Diseases Conference: an analysis of zervimesine’s effect on the components of the neuropsychiatric index, which was used in the Phase 2 COG1201 SHIMMER study (NCT05225415) in participants with DLB; and a proposed composite endpoint containing measures of memory, motor, fluctuations, behavior and psychosis, which may be an effective method of capturing the complexity of DLB symptoms in future clinical trials. First Quarter 2025 Financial Results Cash, cash equivalents, and restricted cash equivalents as of March 31, 2026 were approximately $31.2 million, and total obligated grant funds remaining from the National Institute of Aging, a division of the National Institute of Health were $25.6 million. The Company estimates that it has sufficient cash to fund operations and capital expenditures through the second quarter of 2027. Research and development expenses were $6.1 million for the quarter ended March 31, 2026, compared to $10.8 million for the comparable period in 2025. The decrease in research and development expenses was driven by lower trial activities with contract research organizations and professional fees. General and administrative expenses were $2.7 million for the quarter ended March 31, 2026, compared to $3.0 million for the comparable period in 2025. The decrease in general and administrative expenses was driven primarily by lower stock compensation, compensation and professional fees. The Company reported a net loss of $4.6 million, or $(0.05) per basic and diluted share for the first quarter ended March 31, 2026, compared to a net loss of $8.5 million, or $(0.14) per basic and diluted share for the same period in 2025. About Cognition Therapeutics: Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to helping millions of families seeking effective treatments for devastating neurodegenerative diseases through the development of novel, accessible therapies. The company has led pioneering research into the underlying mechanisms of degenerative nerve disorders. Our scientific approach builds on well-established biological pathways and translates across indications in which toxic oligomers drive disease progression, offering potential in dementia with Lewy bodies (DLB), Alzheimer’s disease, geographic atrophy, Parkinson’s, among others. The company’s lead candidate, zervimesine (CT1812), is an investigational once-daily oral therapy that has demonstrated promise in Phase 2 clinical trials in DLB and mild-to-moderate Alzheimer’s disease. Backed by nearly $200 million in National Institutes of Health and related foundation grants, Cognition Therapeutics continues to advance clinical research in its efforts to bring forth solutions that meet patients where they are and reduce caregiver burden. Learn more at cogrx.com. About Zervimesine (CT1812) Zervimesine (CT1812) is currently being studied in the Phase 2 START Study (NCT05531656) in patients with MCI and early Alzheimer’s disease. Phase 2 clinical studies have been completed in dementia with Lewy bodies (DLB), mild-to-moderate Alzheimer’s disease, and geographic atrophy secondary to dry AMD. Based in part on the strong efficacy signals observed in the Phase 2 SHIMMER study in DLB (NCT05225415), the company plans to advance zervimesine into a late-stage clinical trial for people with DLB psychosis. Zervimesine has been generally well tolerated in clinical studies to date. The USAN Council has adopted zervimesine as the United States Adopted Name (USAN) for CT1812. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release or made during the conference, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding our cash runway, our product candidates, including zervimesine (CT1812), and any expected or implied benefits or results, including that initial clinical results observed with respect to zervimesine will be replicated in later trials and our clinical development plans, including statements regarding our clinical studies of zervimesine, any analyses of the results therefrom, as well as statements regarding our regulatory plans, are forward-looking statements. These statements, including statements relating to the timing and expected results of our clinical trials involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: competition; our ability to secure new (and retain existing) grant funding; our ability to grow and manage growth, maintain relationships with suppliers and retain our management and key employees; our ability to successfully advance our current and future product candidates through development activities, preclinical studies and clinical trials and costs related thereto; uncertainties inherent in the results of preliminary data, pre-clinical studies and earlier-stage clinical trials being predictive of the results of early or later-stage clinical trials; the timing, scope and likelihood of regulatory filings and approvals, including regulatory approval of our product candidates; changes in applicable laws or regulations; the possibility that we may be adversely affected by other economic, business or competitive factors, including ongoing economic uncertainty; our estimates of expenses and profitability; the evolution of the markets in which we compete; our ability to implement our strategic initiatives and continue to innovate our existing products; our ability to defend our intellectual property; the impacts of ongoing global and regional conflicts on our business, supply chain and labor force; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; and the risks and uncertainties described more fully in the “Risk Factors” section of our annual and quarterly reports filed with the Securities & Exchange Commission and are available at www.sec.gov. These risks are not exhaustive and we face both known and unknown risks. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Investor releaseQuarter not tagged2026-03-27Cognition Therapeutics Inc (CGTX) Q4 2025 Earnings Call Highlights: Promising Developments in ...
GuruFocus.com
Cognition Therapeutics Inc (CGTX) Q4 2025 Earnings Call Highlights: Promising Developments in ...
This article first appeared on GuruFocus. Cash and Cash Equivalents: Approximately $37 million as of December 31, 2025. Total Grant Funds Remaining: $35.7 million from the NIA. Research and Development Expenses: $37.2 million for the year ended December 31, 2025, down from $41.7 million in 2024. General and Administrative Expenses: $10.6 million for the year ended December 31, 2025, down from $12.3 million in 2024. Net Loss: $23.5 million or $0.32 per basic and diluted share for the year ended December 31, 2025, compared to $34 million or $0.86 per basic and diluted share for 2024. Warning! GuruFocus has detected 1 Warning Sign with CGTX. Is CGTX fairly valued? Test your thesis with our free DCF calculator. Release Date: March 26, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Cognition Therapeutics Inc (NASDAQ:CGTX) has prioritized the development of zervimesine for the treatment of DLB psychosis, based on promising Phase 2 study results. The company reported an 86% slowing of progression in neuropsychiatric symptoms, particularly psychosis, in DLB patients treated with zervimesine. Cognition Therapeutics Inc (NASDAQ:CGTX) has sufficient cash to fund operations through the second quarter of 2027, providing financial stability for ongoing research and development. The Expanded Access Program for zervimesine has received strong interest from DLB patients and their families, indicating potential demand for the treatment. The company is exploring the potential for zervimesine to be a first-in-class treatment for DLB psychosis, an area with no currently approved medications. Cognition Therapeutics Inc (NASDAQ:CGTX) reported a net loss of $23.5 million for the year ended December 31, 2025, indicating ongoing financial challenges. The company has not yet completed FDA meetings to finalize the regulatory path for zervimesine in DLB psychosis, which could delay progress. There is uncertainty regarding the trial design and endpoints for the upcoming DLB psychosis study, pending regulatory feedback. The company has not announced plans for exploring zervimesine in ocular conditions, limiting its current focus to DLB and Alzheimer's disease. The transition from capsule to tablet form for zervimesine is still underway, which may impact the timeline for clinical trials and eventual commercialization. Q: Do you pla…Read full documentShow less
This article first appeared on GuruFocus. Cash and Cash Equivalents: Approximately $37 million as of December 31, 2025. Total Grant Funds Remaining: $35.7 million from the NIA. Research and Development Expenses: $37.2 million for the year ended December 31, 2025, down from $41.7 million in 2024. General and Administrative Expenses: $10.6 million for the year ended December 31, 2025, down from $12.3 million in 2024. Net Loss: $23.5 million or $0.32 per basic and diluted share for the year ended December 31, 2025, compared to $34 million or $0.86 per basic and diluted share for 2024. Warning! GuruFocus has detected 1 Warning Sign with CGTX. Is CGTX fairly valued? Test your thesis with our free DCF calculator. Release Date: March 26, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Cognition Therapeutics Inc (NASDAQ:CGTX) has prioritized the development of zervimesine for the treatment of DLB psychosis, based on promising Phase 2 study results. The company reported an 86% slowing of progression in neuropsychiatric symptoms, particularly psychosis, in DLB patients treated with zervimesine. Cognition Therapeutics Inc (NASDAQ:CGTX) has sufficient cash to fund operations through the second quarter of 2027, providing financial stability for ongoing research and development. The Expanded Access Program for zervimesine has received strong interest from DLB patients and their families, indicating potential demand for the treatment. The company is exploring the potential for zervimesine to be a first-in-class treatment for DLB psychosis, an area with no currently approved medications. Cognition Therapeutics Inc (NASDAQ:CGTX) reported a net loss of $23.5 million for the year ended December 31, 2025, indicating ongoing financial challenges. The company has not yet completed FDA meetings to finalize the regulatory path for zervimesine in DLB psychosis, which could delay progress. There is uncertainty regarding the trial design and endpoints for the upcoming DLB psychosis study, pending regulatory feedback. The company has not announced plans for exploring zervimesine in ocular conditions, limiting its current focus to DLB and Alzheimer's disease. The transition from capsule to tablet form for zervimesine is still underway, which may impact the timeline for clinical trials and eventual commercialization. Q: Do you plan to seek a partner for further exploration with zervimesine, particularly in ocular conditions? If so, when? A: Lisa Ricciardi, CEO: Our current priority is developing zervimesine for DLB, and we are not looking at an ophthalmology program at the moment. Q: What is the regulatory path forward for the DLB program, and what are your current thoughts on the trial's size, duration, and primary endpoint? A: Anthony Caggiano, CMO: Our intent is to develop zervimesine for a label relating to psychosis in DLB. We have not completed FDA meetings yet to comment on the outcome measure, but we aim to move expeditiously through registrational trials. Details will be clearer post-FDA meeting. Q: Are there any updates on additional trials, such as pharmacology studies, that could aid in moving forward quickly into your DLB psychosis trial? A: Anthony Caggiano, CMO: We are completing low-risk studies like pharmacology and transitioning from a capsule to a tablet form. These are expected to be completed in 2026. Q: How does the effect on behavioral domains in DLB affect your thinking about pursuing behavioral domains in Alzheimer's disease? A: Lisa Ricciardi, CEO: We want to see the results of our START trial in Alzheimer's. While DLB is our first priority, we have not given up on Alzheimer's. The decision will depend on the data from the START trial. Q: With which existing approved CNS medications might zervimesine exhibit synergy, and do you plan to explore these synergies clinically? A: Anthony Caggiano, CMO: Our studies are done on standard care background medications. In Alzheimer's, this includes inhibitors and memantine. In DLB, most patients are on acetylcholinesterase inhibitors. We are also collecting data on potential synergies with immunotherapies like lecanemab and donanemab. Q: What is the hypothesis behind zervimesine's mechanism of action on psychosis, and do you have any similar anecdotes from patients in your SHINE study? A: Anthony Caggiano, CMO: We believe we are interrupting the basic pathophysiology by blocking the interaction of alpha-synuclein with neurons, impacting the broad symptomatology of the disease. We have not shared similar anecdotes from the SHINE study. Q: In your proposed DLB psychosis trial, what would the time point be to the primary endpoint on psychosis, and do you expect to have secondary endpoints involving cognition? A: Anthony Caggiano, CMO: We have not announced the study's specifics, but we will have secondary measures looking at cognition and other functions. The focus on psychosis allows for smaller, faster trials. Q: What about alignment on psychosis with the EMA, and do you anticipate the trial to include both the United States and Europe? A: Anthony Caggiano, CMO: We haven't announced trial locations yet. Once we have FDA agreement, we will seek alignment with the EMA before launching trials there. For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Investor releaseQuarter not tagged2026-03-26Cognition Therapeutics Reports Year End 2025 Financial Results and Provides Clinical Development Update
GlobeNewswire
Cognition Therapeutics Reports Year End 2025 Financial Results and Provides Clinical Development Update
-Advancing zervimesine clinical development in DLB psychosis – - Meeting with FDA Division of Psychiatry expected by mid-2026 - - Management conference call at 8:30 a.m. ET today - PURCHASE, N.Y., March 26, 2026 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (Nasdaq: CGTX), a clinical-stage company developing product candidates that treat neurodegenerative disorders, (the “Company” or “Cognition”), today reported financial results for the fourth quarter and full year ended December 31, 2025. Management will host a live webcast conference call at 8:30 a.m. ET to review these financial results and provide an update on clinical development plans for zervimesine (CT1812) in dementia with Lewy bodies (DLB) and Alzheimer’s disease. “Our progress in 2025 and early 2026 has culminated in a clinical development plan to advance zervimesine for the treatment of psychosis associated with DLB. This patient population has no approved options today and has demonstrated their support of zervimesine’s advancement to registrational trials,” said Lisa Ricciardi, Cognition’s president and CEO. “We received valuable feedback from regulators on both our DLB and Alzheimer’s programs. Our 545-patient ‘START’ trial in early Alzheimer’s disease has completed enrollment. Upon reviewing the results in 2027, we will determine how to advance zervimesine in Alzheimer’s disease. With our near-term focus on DLB, our next steps are centered on a meeting with the FDA Division of Psychiatry to seek alignment on our registrational plan for zervimesine for the treatment of DLB psychosis.” Clinical and Operational Highlights: DLB psychosis Published results from Phase 2 ‘SHIMMER’ COG1201 study in DLB, which were also presented at the International Lewy Body Dementia Conference. Results show strong therapeutic responses across behavioral domains and particularly psychosis, as well as functional, cognitive, and movement domains Launched expanded access program (NCT06961760) for DLB patients following philanthropic donation Planned mid-year meeting with FDA Division of Psychiatry to discuss DLB psychosis and path forward Appointed Dr. David Weinstein, VP of clinical development Alzheimer’s disease Completed enrollment in December 2025 in Phase 2 ‘START’ COG0203 (NCT05531656) study in mild cognitive impairment (MCI) and early Alzheimer's disease; topline results expected in 2027 Conducted end-of-Ph…Read full documentShow less
-Advancing zervimesine clinical development in DLB psychosis – - Meeting with FDA Division of Psychiatry expected by mid-2026 - - Management conference call at 8:30 a.m. ET today - PURCHASE, N.Y., March 26, 2026 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (Nasdaq: CGTX), a clinical-stage company developing product candidates that treat neurodegenerative disorders, (the “Company” or “Cognition”), today reported financial results for the fourth quarter and full year ended December 31, 2025. Management will host a live webcast conference call at 8:30 a.m. ET to review these financial results and provide an update on clinical development plans for zervimesine (CT1812) in dementia with Lewy bodies (DLB) and Alzheimer’s disease. “Our progress in 2025 and early 2026 has culminated in a clinical development plan to advance zervimesine for the treatment of psychosis associated with DLB. This patient population has no approved options today and has demonstrated their support of zervimesine’s advancement to registrational trials,” said Lisa Ricciardi, Cognition’s president and CEO. “We received valuable feedback from regulators on both our DLB and Alzheimer’s programs. Our 545-patient ‘START’ trial in early Alzheimer’s disease has completed enrollment. Upon reviewing the results in 2027, we will determine how to advance zervimesine in Alzheimer’s disease. With our near-term focus on DLB, our next steps are centered on a meeting with the FDA Division of Psychiatry to seek alignment on our registrational plan for zervimesine for the treatment of DLB psychosis.” Clinical and Operational Highlights: DLB psychosis Published results from Phase 2 ‘SHIMMER’ COG1201 study in DLB, which were also presented at the International Lewy Body Dementia Conference. Results show strong therapeutic responses across behavioral domains and particularly psychosis, as well as functional, cognitive, and movement domains Launched expanded access program (NCT06961760) for DLB patients following philanthropic donation Planned mid-year meeting with FDA Division of Psychiatry to discuss DLB psychosis and path forward Appointed Dr. David Weinstein, VP of clinical development Alzheimer’s disease Completed enrollment in December 2025 in Phase 2 ‘START’ COG0203 (NCT05531656) study in mild cognitive impairment (MCI) and early Alzheimer's disease; topline results expected in 2027 Conducted end-of-Phase 2 meeting with FDA and aligned with Agency on development plan for zervimesine in Alzheimer's disease Held scientific advice interaction with European Medicines Agency to discuss the Alzheimer’s disease program Decision expected on registrational program in Alzheimer’s disease to follow results from START study 2025 Financial Results Cash, cash equivalents, and restricted cash equivalents as of December 31, 2025 were approximately $37.0 million, and total obligated grant funds remaining from the National Institute of Aging, a division of the National Institute of Health were $35.7 million. The Company estimates that it has sufficient cash to fund operations and capital expenditures through the second quarter of 2027. Research and development expenses were $37.2 million for the year ended December 31, 2025, compared to $41.7 million for 2024. The change in research and development expenses was driven by the completion of SHINE and SHIMMER clinical trials and associated professional fees. General and administrative expenses were $10.6 million for the year ended December 31, 2025, compared to $12.3 million for 2024. The change in general and administrative expenses was driven primarily by reduced stock-based compensation expenses. The Company reported a net loss of $23.5 million, or $(0.32) per basic and diluted share for the year ended December 31, 2025, compared to a net loss of $34.0 million, or $(0.86) per basic and diluted share for 2024. Conference Call Information Management will host a conference call and live webcast to discuss Cognition’s financial results today at 8:30 a.m. ET. To participate in the conference call, dial (800) 445-7795 (U.S.) or (785) 424-1699 (international) and provide conference ID number CGTXQ4. The audio webcast with live Q&A will be accessible at https://viavid.webcasts.com/starthere.jsp?ei=1756394&tp_key=3ba1f3315f or via the Investor Relations section of Cognition’s website. An archive of the webcast and presentation will be available for 90 days beginning at approximately 10:30 a.m. ET on March 26, 2026. About Cognition Therapeutics: Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to helping millions of families seeking effective treatments for devastating neurodegenerative diseases through the development of novel, accessible therapies. The company has led pioneering research into the underlying mechanisms of degenerative nerve disorders. Our scientific approach builds on well-established biological pathways and translates across indications in which toxic oligomers drive disease progression, offering potential in dementia with Lewy bodies (DLB), Alzheimer’s disease, geographic atrophy, Parkinson’s, among others. The company’s lead candidate, zervimesine (CT1812), is an investigational once-daily oral therapy that has demonstrated promise in Phase 2 clinical trials in DLB and mild-to-moderate Alzheimer’s disease. Backed by nearly $200 million in National Institutes of Health and related foundation grants, Cognition Therapeutics continues to advance clinical research in its efforts to bring forth solutions that meet patients where they are and reduce caregiver burden. Learn more at cogrx.com. About Zervimesine (CT1812) Zervimesine (CT1812) is currently being studied in the Phase 2 START Study (NCT05531656) in patients with MCI and early Alzheimer’s disease. Phase 2 clinical studies have been completed in dementia with Lewy bodies (DLB), mild-to-moderate Alzheimer’s disease, and geographic atrophy secondary to dry AMD. Based in part on the strong efficacy signals observed in the Phase 2 SHIMMER study in DLB (NCT05225415), the company plans to advance zervimesine into a late-stage clinical trial for people with DLB psychosis. Zervimesine has been generally well tolerated in clinical studies to date. The USAN Council has adopted zervimesine as the United States Adopted Name (USAN) for CT1812. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release or made during the conference, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding our cash runway, our product candidates, including zervimesine (CT1812), and any expected or implied benefits or results, including that initial clinical results observed with respect to zervimesine will be replicated in later trials and our clinical development plans, including statements regarding our clinical studies of zervimesine, any analyses of the results therefrom, as well as statements regarding our regulatory plans, are forward-looking statements. These statements, including statements relating to the timing and expected results of our clinical trials involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: competition; our ability to secure new (and retain existing) grant funding; our ability to grow and manage growth, maintain relationships with suppliers and retain our management and key employees; our ability to successfully advance our current and future product candidates through development activities, preclinical studies and clinical trials and costs related thereto; uncertainties inherent in the results of preliminary data, pre-clinical studies and earlier-stage clinical trials being predictive of the results of early or later-stage clinical trials; the timing, scope and likelihood of regulatory filings and approvals, including regulatory approval of our product candidates; changes in applicable laws or regulations; the possibility that we may be adversely affected by other economic, business or competitive factors, including ongoing economic uncertainty; our estimates of expenses and profitability; the evolution of the markets in which we compete; our ability to implement our strategic initiatives and continue to innovate our existing products; our ability to defend our intellectual property; the impacts of ongoing global and regional conflicts on our business, supply chain and labor force; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; and the risks and uncertainties described more fully in the “Risk Factors” section of our annual and quarterly reports filed with the Securities & Exchange Commission and are available at www.sec.gov. These risks are not exhaustive and we face both known and unknown risks. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. This press release was published by a CLEAR® Verified individual.
Investor releaseQuarter not tagged2026-03-26Cognition Therapeutics Q4 Earnings Call Highlights
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Cognition Therapeutics Q4 Earnings Call Highlights
Company pivots to DLB psychosis: Management will prioritize registering zervimesine (CT-1812) for dementia with Lewy bodies psychosis after Phase II SHIMMER data showed benefits across DLB domains — including an 86% slowing on the NPI-12 neuropsychiatric measure — and the FDA told the company the psychosis signal was compelling, directing them to the Division of Psychiatry. Alzheimer's programs remain active: SHINE Phase II reported a 38% reduction in cognitive decline versus placebo (95% reduction in participants with lower p‑tau217), the FDA agreed to p‑tau217 enrichment, and the START trial completed enrollment at 545 participants with top-line results expected in 2027. Cash runway into mid‑2027: The company had about $37M in cash plus $35.7M of NIA grant funds and estimates funding operations through Q2 2027, while 2025 net loss narrowed to $23.5M and R&D and G&A expenses declined year‑over‑year. Interested in Cognition Therapeutics, Inc.? Here are five stocks we like better. November’s Small-Cap Treasures: 3 Stocks Poised for Growth Cognition Therapeutics (NASDAQ:CGTX) used its fourth-quarter and full-year 2025 earnings call to outline a shift in development priorities for its lead candidate, zervimesine (CT-1812), with management saying it will now focus on pursuing a registration path in dementia with Lewy bodies (DLB) psychosis. Chief Executive Officer Lisa Ricciardi said the company has spent the past 18 months reporting Phase II results in DLB (the SHIMMER study) and mild to moderate Alzheimer’s disease (the SHINE study), and has also completed enrollment in the 18-month START trial in early Alzheimer’s disease. She added that the company has held meetings with U.S. and European regulators and, “with data in hand and feedback from regulators,” decided to prioritize zervimesine’s development for DLB psychosis. → ASML’s $8B Deal: More Than a Purchase, It's a Prophecy Chief Medical Officer Dr. Tony Caggiano described the rationale for the pivot, pointing to published SHIMMER results that, he said, showed zervimesine had a “meaningful impact across DLB symptom domains,” including movement, cognition, function, and behavior. He highlighted neuropsychiatric outcomes measured using the NPI-12 (a 12-item index of neuropsychiatric symptoms), stating zervimesine showed “an 86% slowing of progression relative to placebo” on neuropsychiatric symptoms. Within b…Read full documentShow less
Company pivots to DLB psychosis: Management will prioritize registering zervimesine (CT-1812) for dementia with Lewy bodies psychosis after Phase II SHIMMER data showed benefits across DLB domains — including an 86% slowing on the NPI-12 neuropsychiatric measure — and the FDA told the company the psychosis signal was compelling, directing them to the Division of Psychiatry. Alzheimer's programs remain active: SHINE Phase II reported a 38% reduction in cognitive decline versus placebo (95% reduction in participants with lower p‑tau217), the FDA agreed to p‑tau217 enrichment, and the START trial completed enrollment at 545 participants with top-line results expected in 2027. Cash runway into mid‑2027: The company had about $37M in cash plus $35.7M of NIA grant funds and estimates funding operations through Q2 2027, while 2025 net loss narrowed to $23.5M and R&D and G&A expenses declined year‑over‑year. Interested in Cognition Therapeutics, Inc.? Here are five stocks we like better. November’s Small-Cap Treasures: 3 Stocks Poised for Growth Cognition Therapeutics (NASDAQ:CGTX) used its fourth-quarter and full-year 2025 earnings call to outline a shift in development priorities for its lead candidate, zervimesine (CT-1812), with management saying it will now focus on pursuing a registration path in dementia with Lewy bodies (DLB) psychosis. Chief Executive Officer Lisa Ricciardi said the company has spent the past 18 months reporting Phase II results in DLB (the SHIMMER study) and mild to moderate Alzheimer’s disease (the SHINE study), and has also completed enrollment in the 18-month START trial in early Alzheimer’s disease. She added that the company has held meetings with U.S. and European regulators and, “with data in hand and feedback from regulators,” decided to prioritize zervimesine’s development for DLB psychosis. → ASML’s $8B Deal: More Than a Purchase, It's a Prophecy Chief Medical Officer Dr. Tony Caggiano described the rationale for the pivot, pointing to published SHIMMER results that, he said, showed zervimesine had a “meaningful impact across DLB symptom domains,” including movement, cognition, function, and behavior. He highlighted neuropsychiatric outcomes measured using the NPI-12 (a 12-item index of neuropsychiatric symptoms), stating zervimesine showed “an 86% slowing of progression relative to placebo” on neuropsychiatric symptoms. Within behavioral symptoms, Caggiano said the effects were particularly notable for hallucinations and delusions—collectively referred to as psychosis. He said the company discussed the psychosis findings with the FDA during a Type C meeting in January and that the FDA agreed the effects on psychosis were compelling, directing Cognition to the FDA’s Division of Psychiatry to define a path toward registration. → Is 2026 the Year of Space Stocks? 2 Stocks to Watch Caggiano noted the Division of Psychiatry has overseen registrational studies and new drug applications for Rexulti (for Alzheimer’s agitation) and Nuplazid (for Parkinson’s disease psychosis). The company said a meeting request with the division has already been filed, and it expects to provide an update after receiving official meeting minutes “mid-year.” On the call, Cognition emphasized both the prevalence and clinical burden of psychosis in DLB. Caggiano said psychosis is more prevalent in DLB than in other dementias and often occurs early, adding that as many as 80% of DLB patients experience psychosis and that hallucinations are among the core clinical criteria for a DLB diagnosis. → GE Vernova: AI's Thirst for Power Creates a New Class of Winner He also said there are no approved medications for DLB patients with psychosis and that many patients cannot tolerate traditional antipsychotics. While many development efforts in DLB psychosis focus on acute symptom treatment via receptor modulation, Cognition contrasted its approach, with Caggiano saying zervimesine is intended to interrupt basic disease pathophysiology and has shown robust efficacy over six months in certain DLB symptom domains, “most notably behavioral symptoms including psychosis.” Caggiano added that in SHIMMER, patients with psychosis, anxiety, aggression, and agitation treated with zervimesine were stable compared with placebo participants whose symptoms worsened. Based on the strength of the psychosis signal, he said the company expects registrational studies focused on psychosis to be smaller and shorter than trials focused on cognition and general symptomatology, which management believes could expedite a path to market. Ricciardi said anecdotal feedback from the company’s expanded access program (EAP) also supported the decision to pursue DLB psychosis. She said the EAP began in mid-2025 after a philanthropic donation from a patient’s family whose relative had been in the SHIMMER trial and wanted to maintain access to zervimesine. According to Ricciardi, the EAP “quickly filled to capacity,” and the company continues to receive inquiries from patients and families seeking access or extended access. She noted the EAP is open-label, giving the company an opportunity to hear directly from patients and caregivers, and said the response has been consistent that participants believe zervimesine is making a tangible difference in daily life. Ricciardi said the company currently has funding to continue the EAP for another nine to 12 months. While prioritizing DLB psychosis, Cognition said it remains committed to Alzheimer’s disease development. Ricciardi reviewed results from the Phase II SHINE study in mild to moderate Alzheimer’s disease, completed in 2024, in which the company reported a 38% reduction in cognitive decline versus placebo on the ADAS-Cog 11 scale. She said the magnitude was comparable to effects observed in Phase III trials for immunotherapies Kisunla and Leqembi, as described by management during the call. Ricciardi added that in SHINE, the treatment effect was most pronounced in participants with lower blood levels of p-tau217, who experienced a 95% reduction in cognitive decline. She said that during a 2025 end-of-Phase II meeting, the FDA agreed with Cognition’s proposal to screen for participants with lower p-tau217 levels, which could expedite recruitment and enrich enrollment for those most likely to benefit. The company also provided an update on START, its Phase II trial in mild cognitive impairment and early Alzheimer’s disease, stating it met its enrollment goal at the end of 2025 with 545 participants. Top-line results are expected in 2027 after the last participants complete the 18-month treatment period. Chief Financial Officer John Doyle reported that cash, cash equivalents, and restricted cash equivalents totaled approximately $37 million as of December 31, 2025. He added that total grant funds remaining from the National Institute on Aging were $35.7 million, and the company estimates it has sufficient cash to fund operations and capital expenditures through the second quarter of 2027. Doyle said research and development expenses were $37.2 million for the year ended December 31, 2025, down from $41.7 million in 2024, driven by completion of SHINE and SHIMMER and related professional fees. General and administrative expenses were $10.6 million, down from $12.3 million, primarily due to reduced stock-based compensation expense. Cognition reported a net loss of $23.5 million, or $0.32 per basic and diluted share, compared with a net loss of $34 million, or $0.86 per basic and diluted share, in 2024. In the Q&A, management said its near-term priority is DLB and that it is not pursuing an ophthalmology program at this time. Executives also said additional supporting studies—including food-effect, drug-drug interaction, and other pharmacology work—are underway, along with a planned formulation change from a capsule to a tablet, with the company aiming to complete these activities during 2026. When asked about combination use, management said prior studies were conducted on top of standard-of-care background medications, including acetylcholinesterase inhibitors and memantine in Alzheimer’s disease, and noted most DLB participants in SHIMMER were on acetylcholinesterase inhibitors. The company also said START allows participants to be on stable maintenance courses of immunotherapies such as lecanemab and donanemab, with an intent to collect information about potential additional benefit in combination. In closing remarks, Ricciardi reiterated that Cognition is looking forward to meeting with the FDA’s Division of Psychiatry to finalize plans and timing for DLB psychosis studies, describing the indication as an important unmet need and pointing to both Phase II findings and feedback from the expanded access program. Cognition Therapeutics, Inc is a clinical-stage biopharmaceutical company focused on developing disease-modifying therapies for neurodegenerative disorders, with an emphasis on Alzheimer's disease. The company's lead investigational candidate, CT1812, is an oral small molecule that antagonizes the sigma-2 receptor complex to protect synapses from amyloid-beta oligomer toxicity. By targeting a novel mechanism of action, Cognition Therapeutics aims to slow or reverse cognitive decline in patients living with Alzheimer's disease. CT1812 has successfully completed Phase 1 safety studies and preliminary Phase 2a trials, and is currently being evaluated in multiple Phase 2 clinical studies across North America and Europe in patients with mild-to-moderate Alzheimer's disease. The article "Cognition Therapeutics Q4 Earnings Call Highlights" was originally published by MarketBeat.
TranscriptFY2025 Q42026-03-26FY2025 Q4 earnings call transcript
Earnings source - 53 paragraphs
FY2025 Q4 earnings call transcript
Hello and welcome everyone joining today's Cognition Therapeutics fourth quarter and full year 2025 earnings call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question and answer session. To register to ask a question at any time, please press star one on your telephone keypad. Please note this call is being recorded. We are standing by if you should need any assistance. It is now my pleasure to turn the meeting over to Mike Moyer with LifeSci Advisors. Please go ahead.
Thank you, operator, and good morning everyone. Welcome to Cognition Therapeutics' fourth quarter and year-end 2025 results conference call. With me today are Lisa Ricciardi, President and Chief Executive Officer, John Doyle, Chief Financial Officer, and Dr. Tony Caggiano, Chief Medical Officer. This morning, the company issued a press release detailing its 2025 fourth quarter and year-end results. We encourage everyone to read this morning's press release, as well as Cognition's annual report on Form 10-K, which is now filed with the SEC and available on our website. In addition, this conference call is being webcast through the company's website and will be archived for 30 days. Please note that certain information discussed on the call today is covered under the safe harbor provisions of the Private Securities Litigation Reform Act. We caution listeners that during this call, management will be making forward-looking statements.
Actual results could differ materially from those stated or implied by those forward-looking statements due to the risks and uncertainties associated with the company's business. These forward-looking statements are qualified by the cautionary statements contained in Cognition's press releases and SEC filings, including its annual report on Form 10-K and previous filings. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast. Cognition undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. With that, I would like to turn the call over to CEO Lisa Ricciardi.
Mike, thank you. Good morning, everyone. Cognition's primary focus since its inception has been on the development of zervimesine for patients with debilitating neurodegenerative diseases. Zervimesine is the USAN name for CT-1812. Over the past 18 months, we've reported data from two phase II studies, one in dementia with Lewy bodies and a second one in mild to moderate Alzheimer's disease. Finally, we concluded enrollment in our 18-month START trial. This is a 545-patient study in early Alzheimer's disease, and we've held meetings with both U.S. and European regulators. With data in hand and feedback from regulators, we've made the decision to prioritize development of zervimesine for the treatment of DLB psychosis. I'll turn the call over now to Tony Caggiano, our Chief Medical Officer, to walk you through the rationale.
Thank you. We recently published results from our phase II SHIMMER study in DLB and showed that zervimesine has a meaningful impact across DLB symptom domains, specifically movement, cognition, function, and behavior, including psychosis. These behavioral symptoms were the subject of our recent presentation at the Alzheimer's and Parkinson's Disease Conference last week in Copenhagen. These symptoms were measured in the phase II trial using an assessment called the NPI-12, which is a 12-item index of neuropsychiatric symptoms. Zervimesine showed a strong impact on the neuropsychiatric symptoms with an 86% slowing of progression relative to placebo. Within the NPI-12 behavioral symptoms, the effects of zervimesine were particularly notable for hallucinations and delusions, which collectively we refer to as psychosis.
This is an important finding and one of the topics that we discussed both with the FDA in our FDA type C meeting in January, as well as with our peers during the ADPD meeting. We are very encouraged by the response to this plan from our KOLs and expert consultants at ADPD. In our conversations with the FDA team, they agreed that the effects on psychosis were compelling and directed us to the Division of Psychiatry in order to define a path towards registration. The Division of Psychiatry has familiarity with trials designed to measure psychosis associated with neurologic disease. They have recently overseen registrational studies and new drug applications for Rexulti, for Alzheimer's agitation, and Nuplazid for Parkinson's disease psychosis. We look forward to meeting with the Division of Psychiatry to discuss a registrational plan for the treatment of DLB psychosis.
A meeting request with the division has already been filed. Many of you who follow this space know that psychosis is commonly associated with neurodegenerative diseases like Alzheimer's disease, frontotemporal dementia, Parkinson's disease dementia, and DLB. In DLB, psychosis is more prevalent than in other dementias and often occurs early in the course of the disease. As many as 80% of DLB patients experience psychosis. The presence of hallucinations is one of the core clinical criteria for a diagnosis of DLB. Unlike psychiatric conditions like schizophrenia, some DLB patients recognize that these images, sensations, or sounds that they are experiencing are actually hallucinations. This is understandably very stressful, both to patients and to their families, and can lead to withdrawal from social activities and isolation, negatively impacting the entire family unit. Delusions are also common in DLB.
These are often impostor delusions, where patients believe their friends and family members have been replaced by others pretending to be their family members. These delusions are difficult to manage and can accelerate the family's decision to move their loved ones into nursing care facilities. As you can see, psychosis is extremely debilitating for DLB patients. There are no approved medications for DLB patients with psychosis. Neurologists and psychiatrists have few treatment options for hallucinations and delusions, as most patients cannot tolerate traditional antipsychotics. Few clinical trials for patients with DLB psychosis have been conducted, and none have been successful to date. Most drugs in development for DLB psychosis are acute treatments as they modulate specific receptors involved in psychosis. The difference between the acute treatment and Cognition's approach is the mechanism.
Acute treatment acts rapidly to impact specific symptoms but does not change the course of the disease. Patients' disease continue to progress, their symptoms will worsen, and these acute treatments may become less effective over time. Zervimesine works differently by interrupting the basic pathophysiology of the disease. It has shown robust efficacy over six months in certain symptom domains of DLB, most notably behavioral symptoms including psychosis. In the phase II SHIMMER study, patients with psychosis, anxiety, aggression, and agitation with zervimesine were stable compared to these same symptoms that worsened in placebo-treated participants. As we mentioned, these data were presented last week at the ADPD meeting, and the posters are available on our website. Given the strength of the psychosis data, we expect registrational studies focused on psychosis to be smaller and shorter than studies that focus on cognition and general symptomatology.
Therefore, we believe that our decision to develop zervimesine for DLB psychosis will allow us to expedite its path to market. After completing our meeting with the Division of Psychiatry and receiving the official meeting minutes mid-year, we will issue an update in a press release.
Thank you, Tony. Before I move on, I'll add that one of the factors that led us to decide to pursue DLB psychosis was the anecdotal feedback from our expanded access program, or as we refer to it, our EAP program. We started this program in mid-2025 after we received a philanthropic donation from a patient's family. The patient had been in our phase II SHIMMER study. This family was driven to find a way to maintain access to zervimesine because of the impact they believe it had on the patient with DLB. They were focused not only on their mental health needs, but that of the broader SHIMMER trial population. Once the EAP started, it quickly filled to capacity. The level of interest from DLB patients and their physicians was and is astounding.
We still get queries from patients and families about gaining access or extending access to the drug. Now, since the EAP is open label, we're in a unique position to hear directly from patients and their loved ones, and the response has been consistent that people believe zervimesine is making a tangible difference in their daily lives. These experiences fuel our desire to complete our development work, and if approved, see this drug available all over the world. Right now, we have funding to continue the EAP program for another nine to 12 months. Now, moving on to Alzheimer's disease. As you may recall, we completed the phase II SHINE study in mild to moderate Alzheimer's disease in 2024. We saw a reduction in cognitive decline of 38%, and that is on the ADAS-Cog 11 scale in treated versus placebo patients.
This was comparable to the effects observed in phase III trials with the immunotherapeutics Kisunla and Leqembi. In SHINE, the treatment effect was most pronounced in patients with lower levels of a protein called p-tau217 in their blood. These participants experienced a 95% reduction in cognitive decline. When we met with the FDA during an end of phase II meeting in 2025, the FDA agreed with our proposal to screen for participants with lower levels of p-tau217. This strategy could expedite patient recruitment. Importantly, it will also enrich the study with patients who are most likely to benefit from zervimesine treatment. Zervimesine currently is being studied in a phase II trial called START in patients with mild cognitive impairment or MCI and early Alzheimer's disease.
This study met its enrollment goal at the end of 2025 with a total of 545 participants. Top line results are expected in 2027 after the last participants complete the 18-month treatment period. Given the strong results we observed with zervimesine in the mild to moderate AD trial, we remain committed to developing zervimesine for Alzheimer's disease, and we look forward to the results of our START trial. With that, John Doyle will review our financial results and provide more color around our cash position and capital requirements. John.
Thank you, Lisa. Cash, cash equivalents, and restricted cash equivalents as of December 31st, 2025, were approximately $37 million. Total grant funds remaining from the NIA were $35.7 million.
We estimate that the company has sufficient cash to fund operations and capital expenditures through the second quarter of 2027. Research and development expenses were $37.2 million for the year ended December 31st, 2025, compared to $41.7 million for 2024. The change in R&D expenses was driven by the completion of SHINE and SHIMMER clinical trials and associated professional fees. General and administrative expenses were $10.6 million for the year ended December 31st, 2025, compared to $12.3 million for 2024. This change in G&A expenses was driven primarily by reduced stock-based compensation expenses. The company reported net loss of $23.5 million, or $0.32 per basic and diluted share for the year ended December 31st, 2025.
This is compared to a net loss of $34 million or $0.86 per basic and diluted share for 2024. Lisa?
Thank you, John. I'll now turn the call back to our operator, who can open this up to questions. Nikki?
Thank you. If you would like to ask a question, please press star one on your keypad. To leave the queue at any time, press star two. Once again, that is star two to ask a question. We will pause for a moment to allow everyone a chance to join the queue. We'll take our first question from Ram Selvaraju with H.C. Wainwright. Please go ahead. Your line is open.
Hi, this is Katie on for Ram. Do you guys plan to seek a partner for further exploration with zervimesine, particularly in ocular conditions? If so, when?
Hi. Good morning. Nice to talk to you. Right now, our priority is on, excuse me, developing zervimesine for DLB. We're not looking at an ophthalmology program at the moment. Thank you for the question.
Great. Thank you.
Thank you. We will move next with William Wood with B. Riley Securities. Please go ahead. Your line is open.
Hi. Thanks for taking our questions and congratulations on the very nice ending of the year. Just trying to sort of think about in terms of the DLB program, maybe you could walk us through what you see as the regulatory path forward. Should we expect your next trial, I believe you said in the past it might be a phase IIb. Would that be expected to be registrational, or do you think you could go to phase III directly? What are your current thinking on your DLB trial, both in terms of size and duration but also primary endpoint? I have a follow-up.
Yeah. Yeah, thank you for the question. As we mentioned, our intent is to develop this now for a label relating to psychosis in DLB, like we saw, as just mentioned, with Nuplazid and Rexulti in Alzheimer's disease and Parkinson's disease dementia. Now, you know, we have not completed, you know, the FDA meetings yet to comment on exactly what the outcome measure will be. We have to work on that, but you can imagine it'll be very similar to what we've done here before. Certainly our intent is to move as expeditiously as possible through registrational trials. Again, until we have the meeting with FDA and have minutes, it'd be premature to comment exactly what that would look like.
Okay, got it. In terms of you also had reported that you had numerous other additional trials, including pharmacology in healthy volunteers, DDI, bioavailability food. I believe also you were switching from a capsule to a tablet formation. Is there any update on any of these additional trials that could aid in your moving forward quickly into your DLB psychosis? Additionally, what other remaining gating steps do you sort of see in getting that DLB psychosis trial underway once you have the regulatory feedback?
Yeah, you're correct. Those are the studies that we'd want to complete before starting those trials. Again, you know, based on the nature of these studies, these are very low-risk studies, right? They're really informing us on things such as do we need to add any instructions as to whether people should take drug with or without food or have no instructions whatsoever. These are extremely low risk that we just need to get behind us. As you mentioned, you're correct, we're moving from a capsule form to a tablet form, which we think will be better as this is eventually, right, hopefully, once approved, commercialized. Those are all moving along and we look to accomplish this, you know, this all in this year, 2026.
Okay. Got it. Helpful. Thank you very much. I'll hop back in the queue.
Thank you. We will move next with Daniil Gataulin with Chardan. Please go ahead. Your line is open.
Hey. Good morning, guys. Thank you for taking my question. First, how does the effect of zervimesine on behavioral domains in DLB affect your thinking about pursuing also behavioral domains in Alzheimer's disease? Or is the current focus still on an overall slowing of the disease progression?
Thanks for the question, Daniil. We want to see the results of our START trial. Big trial, important trial. We hope it builds on the SHINE results, which we've already seen, particularly those impressive effects in patients with low p-tau. With that kind of data, we can then prioritize in the out years, what do we do next? Right now on the fairway is the DLB study as a first priority. While that study is recruiting and getting underway, we anticipate seeing the results of START, which is the early AD trial. We by no means given up on AD. It's a question of prioritization. As a small company, we've chosen DLB psychosis, and we'll get feedback. Such great information sometime next year from START in AD.
Got it. Okay. Makes sense. For DLB, you will be having the meeting with the FDA. What about alignment on psychosis with the EMA? Where are you in those meetings, and do you anticipate the trial to be including sites both in the United States and Europe to support global approval?
Yeah, thank you. We haven't really announced exactly where the trial will be. Certainly, once we have agreement with FDA, you know, as we've done with AD, we'll want to seek alignment with EMA before launching trials there. It's a little premature to talk about exactly what those plans are.
Got it. All right. Thank you. Thank you for taking my questions.
Thank you. We do have a follow-up from Ram Selvaraju with H.C. Wainwright Please go ahead. Your line is open.
Thank you. With which existing approved CNS medications might zervimesine exhibit synergy? Do you guys plan to explore any of those synergies, clinically in the foreseeable future?
We have a bit, right? Most of our studies are done on standard of care background medications. Obviously in Alzheimer's disease and our mild to moderate study, this was acetylcholinesterase inhibitors and memantine. Interestingly now, most people with DLB are also on acetylcholinesterase inhibitors. In our trial, and this is all published information, about 80 or 85% of individuals were on acetylcholinesterase inhibitors. The effects of our drug have been on top of these standard of care. Similarly, in our START trial in early AD, we've allowed people to be on and have been on, provided they are on a stable maintenance course of the immunotherapies, right? Lecanemab and donanemab.
The intent there, as much as you suggested, to begin to collect data not only on zervimesine alone, but is there any indication that there might be an additional benefit of using the drugs in combination. That's the information that we have and will be giving in the near future.
Perfect. Thank you so much.
Thank you. We will move next with Sumant Kulkarni with Canaccord. Please go ahead. Your line is open.
Good morning. Thanks for taking my questions. I have a couple. First, what's the state of the art in terms of the hypothesis behind zervimesine's mechanism of action on psychosis? And do you have any similar anecdotes from patients in your SHINE study?
Sumant, what was the second part of your second question?
The second part was if, just like you had some anecdotes that led you to explore psychosis in DLB, did you have any similar anecdotes on the Alzheimer's study?
Got it. Tony, you wanna take the first question?
Sure, yeah. You know, we mentioned briefly, but obviously we didn't get into too much detail in our discussion. You're right. We don't believe that we are impacting the receptors particularly, you know, known to be responsible for psychosis. What we believe, much like the global state of the disease, is that we're interrupting the basic pathophysiology by just like in Alzheimer's disease, blocking the ability of Aβ oligomers to interact with neurons. We have similar data showing that we prevent the interaction of alpha-synuclein from interacting with their receptors, thereby preventing, right, the basic damage to neurons. Now, the symptomatology in DLB from alpha-synuclein toxicity is based on where that toxicity is occurring.
Again, we believe that we are able to impact the broad symptomatology of the disease and that those effects, as we noted, were most notable or most measurable within the psychosis. That's what we're pursuing.
Got it. My follow-up. In your DLB, I guess in your proposed DLB psychosis trial, what would the time point be to the primary endpoint on psychosis? And do you expect to have secondary endpoints involving cognition? I'm asking because, with reference to your potential to eventually attain a disease-modifying label.
We have not announced exactly what the study looks like and the duration and so forth. That'll certainly be a topic of our discussion with FDA. You know, obviously you've seen the results of our SHIMMER trial, and we won't want to stray too much from that design. Absolutely we will have other measures, secondary measures which you know are ranked and protected, looking at you know cognition and motor function and sleep and so forth. Again, because as you saw with the results of the SHIMMER trial, you know, we are very impressed by the global impact of the drug on the disease. Certainly eventually we'll want to study those other impacts as well.
The reason we're focusing right now on psychosis is because the impact of the drug on psychosis is really quite strong, and that gives us the ability to do smaller, faster trials and hopefully a much more efficient path to market.
Got it. Thank you.
Thank you. At this time, there are no further questions in queue. I will now turn the meeting back to CEO Lisa Ricciardi for closing comments.
All right, Nikki. We are looking forward to meeting with the FDA's Division of Psychiatry shortly. As Tony said, we can finalize our plans and timing for studying DLB psychosis. This is an important indication. It's currently unaddressed by any approved or unapproved medications. Based on our phase II findings and anecdotal feedback, as we discussed in participants in our EAP program, we believe zervimesine has the potential to be a first-in-class treatment option for DLB patients with psychosis. With that, thank you all for joining us today.
Thank you. This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect.
Investor releaseQuarter not tagged2026-03-23Cognition Therapeutics to Report Fourth Quarter and Year End 2025 Financial Results
GlobeNewswire
Cognition Therapeutics to Report Fourth Quarter and Year End 2025 Financial Results
Conference Call and Live Webcast Scheduled for March 26, 2026 PURCHASE, N.Y., March 23, 2026 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (Nasdaq: CGTX), a clinical-stage company developing product candidates that treat neurodegenerative disorders, (the “Company” or “Cognition”), plans to release financial results for the fourth quarter and full year ended December 31, 2025 on Thursday, March 26, 2026 before the market open. Management will host a conference call at 8:30 a.m. ET on the same day to review the financial and operating results and provide a business update. Conference Call Information To participate in the conference call, dial (800) 445-7795 (U.S.) or (785) 424-1699 (international) and provide conference ID number CGTXQ4. The webcast with live Q&A will be accessible at https://viavid.webcasts.com/starthere.jsp?ei=1756394&tp_key=3ba1f3315f or via the Investor Relations section of Cognition’s website. An archive of the webcast and presentation will be available for 90 days beginning at approximately 10:30 a.m. ET on March 26, 2026. About Cognition Therapeutics: Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to helping millions of families seeking effective treatments for devastating neurodegenerative diseases through the development of novel, accessible therapies. The company has led pioneering research into the underlying mechanisms of degenerative nerve disorders. Our scientific approach builds on well-established biological pathways and translates across indications in which toxic oligomers drive disease progression, offering potential in dementia with Lewy bodies (DLB), Alzheimer’s disease, geographic atrophy, Parkinson’s, among others. The company’s lead candidate, zervimesine (CT1812), is an investigational once-daily oral therapy that has demonstrated promise in Phase 2 clinical trials in DLB and mild-to-moderate Alzheimer’s disease. Backed by nearly $200 million in National Institutes of Health and related foundation grants, Cognition Therapeutics continues to advance clinical research in its efforts to bring forth solutions that meet patients where they are and reduce caregiver burden. Learn more at cogrx.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in thi…Read full documentShow less
Conference Call and Live Webcast Scheduled for March 26, 2026 PURCHASE, N.Y., March 23, 2026 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (Nasdaq: CGTX), a clinical-stage company developing product candidates that treat neurodegenerative disorders, (the “Company” or “Cognition”), plans to release financial results for the fourth quarter and full year ended December 31, 2025 on Thursday, March 26, 2026 before the market open. Management will host a conference call at 8:30 a.m. ET on the same day to review the financial and operating results and provide a business update. Conference Call Information To participate in the conference call, dial (800) 445-7795 (U.S.) or (785) 424-1699 (international) and provide conference ID number CGTXQ4. The webcast with live Q&A will be accessible at https://viavid.webcasts.com/starthere.jsp?ei=1756394&tp_key=3ba1f3315f or via the Investor Relations section of Cognition’s website. An archive of the webcast and presentation will be available for 90 days beginning at approximately 10:30 a.m. ET on March 26, 2026. About Cognition Therapeutics: Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to helping millions of families seeking effective treatments for devastating neurodegenerative diseases through the development of novel, accessible therapies. The company has led pioneering research into the underlying mechanisms of degenerative nerve disorders. Our scientific approach builds on well-established biological pathways and translates across indications in which toxic oligomers drive disease progression, offering potential in dementia with Lewy bodies (DLB), Alzheimer’s disease, geographic atrophy, Parkinson’s, among others. The company’s lead candidate, zervimesine (CT1812), is an investigational once-daily oral therapy that has demonstrated promise in Phase 2 clinical trials in DLB and mild-to-moderate Alzheimer’s disease. Backed by nearly $200 million in National Institutes of Health and related foundation grants, Cognition Therapeutics continues to advance clinical research in its efforts to bring forth solutions that meet patients where they are and reduce caregiver burden. Learn more at cogrx.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release or made during the conference, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding our product candidates, including zervimesine (CT1812), and any expected or implied benefits or results, including that initial clinical results observed with respect to zervimesine will be replicated in later trials and our clinical development plans, including statements regarding our clinical studies of zervimesine, any analyses of the results therefrom, as well as statements regarding our regulatory plans are forward-looking statements. These statements, including statements relating to the timing and expected results of our clinical trials involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: competition; our ability to secure new (and retain existing) grant funding; our ability to grow and manage growth, maintain relationships with suppliers and retain our management and key employees; our ability to successfully advance our current and future product candidates through development activities, preclinical studies and clinical trials and costs related thereto; uncertainties inherent in the results of preliminary data, pre-clinical studies and earlier-stage clinical trials being predictive of the results of early or later-stage clinical trials; the timing, scope and likelihood of regulatory filings and approvals, including regulatory approval of our product candidates; changes in applicable laws or regulations; the possibility that we may be adversely affected by other economic, business or competitive factors, including ongoing economic uncertainty; our estimates of expenses and profitability; the evolution of the markets in which we compete; our ability to implement our strategic initiatives and continue to innovate our existing products; our ability to defend our intellectual property; the impacts of ongoing global and regional conflicts on our business, supply chain and labor force; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; and the risks and uncertainties described more fully in the “Risk Factors” section of our annual and quarterly reports filed with the Securities & Exchange Commission and are available at www.sec.gov. These risks are not exhaustive and we face both known and unknown risks. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. This press release was published by a CLEAR® Verified individual.
Investor releaseQuarter not tagged2026-01-06Cognition Therapeutics Publishes Phase 2 Clinical Results Showing Zervimesine’s Potential to Slow the Progression of Dementia with Lewy Bodies
GlobeNewswire
Cognition Therapeutics Publishes Phase 2 Clinical Results Showing Zervimesine’s Potential to Slow the Progression of Dementia with Lewy Bodies
- Zervimesine exhibited meaningful improvement in behavioral, functional, cognitive, and movement measures compared to placebo - PURCHASE, N.Y., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (NASDAQ: CGTX), today announced that a manuscript entitled, “Phase 2 Study of Zervimesine (CT1812) in Participants with Mild-to-Moderate Dementia with Lewy Bodies (DLB)” (doi: 10.1002/alz.71004) has been published in the journal, Alzheimer's & Dementia, the journal of the Alzheimer’s Association. Results from this study were first presented in January 2025 at the International Lewy Body Dementia Conference in Amsterdam. “The Phase 2 SHIMMER study, our first in DLB, met its primary goal of confirming zervimesine’s safety and tolerability,” explained Anthony O. Caggiano, Cognition’s chief medical officer. "Importantly, zervimesine was also shown to have a favorable impact on behavioral, cognitive, functional, and movement domains, many of which are core clinical features of DLB. There are currently no approved disease-modifying treatments for DLB, highlighting the unmet need for novel therapies.” The Phase 2 SHIMMER study randomized 130 adults with mild-to-moderate DLB who took a daily oral dose of zervimesine or placebo for six months. The study met its primary endpoint of safety and tolerability. In addition, after six months of treatment, zervimesine-treated participants’ neuropsychiatric symptoms improved relative to placebo as measured by the neuropsychiatric inventory (NPI). The NPI assesses the frequency and severity of 12 separate behavioral symptoms, including hallucinations, delusions, anxiety and agitation. These symptoms are hallmarks of DLB and can be especially debilitating for patients. Zervimesine treatment also resulted in an improvement in fluctuations, which are described as unpredictable lapses in attention or consciousness that can last for minutes, hours or days. After six months on zervimesine, participants experienced fewer and/or shorter cognitive fluctuations, compared to placebo-treated participants. Activities of daily living such as dressing, bathing, and writing, were also improved relative to placebo after six months of zervimesine treatment. Most treatment-related adverse events were mild or moderate, consistent with previous clinical experience. “DLB has a number of complex symptoms, which can make it difficult to care for…Read full documentShow less
- Zervimesine exhibited meaningful improvement in behavioral, functional, cognitive, and movement measures compared to placebo - PURCHASE, N.Y., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (NASDAQ: CGTX), today announced that a manuscript entitled, “Phase 2 Study of Zervimesine (CT1812) in Participants with Mild-to-Moderate Dementia with Lewy Bodies (DLB)” (doi: 10.1002/alz.71004) has been published in the journal, Alzheimer's & Dementia, the journal of the Alzheimer’s Association. Results from this study were first presented in January 2025 at the International Lewy Body Dementia Conference in Amsterdam. “The Phase 2 SHIMMER study, our first in DLB, met its primary goal of confirming zervimesine’s safety and tolerability,” explained Anthony O. Caggiano, Cognition’s chief medical officer. "Importantly, zervimesine was also shown to have a favorable impact on behavioral, cognitive, functional, and movement domains, many of which are core clinical features of DLB. There are currently no approved disease-modifying treatments for DLB, highlighting the unmet need for novel therapies.” The Phase 2 SHIMMER study randomized 130 adults with mild-to-moderate DLB who took a daily oral dose of zervimesine or placebo for six months. The study met its primary endpoint of safety and tolerability. In addition, after six months of treatment, zervimesine-treated participants’ neuropsychiatric symptoms improved relative to placebo as measured by the neuropsychiatric inventory (NPI). The NPI assesses the frequency and severity of 12 separate behavioral symptoms, including hallucinations, delusions, anxiety and agitation. These symptoms are hallmarks of DLB and can be especially debilitating for patients. Zervimesine treatment also resulted in an improvement in fluctuations, which are described as unpredictable lapses in attention or consciousness that can last for minutes, hours or days. After six months on zervimesine, participants experienced fewer and/or shorter cognitive fluctuations, compared to placebo-treated participants. Activities of daily living such as dressing, bathing, and writing, were also improved relative to placebo after six months of zervimesine treatment. Most treatment-related adverse events were mild or moderate, consistent with previous clinical experience. “DLB has a number of complex symptoms, which can make it difficult to care for patients at home as their disease worsens.” added Lisa Ricciardi, Cognition’s president and CEO. “Zervimesine showed meaningful impact across symptom domains including behavior, cognition, fluctuations, and motor function. This represents a clinically meaningful impact for DLB patients and their caregivers.” The U.S. Food and Drug Administration (FDA) will meet Cognition during a Type C meeting scheduled for the second half of January 2026. During the meeting, the next clinical studies for zervimesine in DLB will be discussed, with a focus on clinically meaningful endpoints. Meeting minutes are expected to follow the Type C meeting. Publication Citation: Galvin JE, Tolea MI, Scharre DW, et al. Phase 2 Study of Zervimesine (CT1812) in Participants with Mild-to-Moderate Dementia with Lewy Bodies (DLB). Alzheimer's Dement. 2025; 21:e71004. About the SHIMMER Study The SHIMMER study (NCT05225415) was an exploratory double-blind, placebo-controlled Phase 2 clinical trial that enrolled 130 adults with mild-to-moderate DLB, who were randomized to either daily oral doses of zervimesine (100 mg or 300 mg) or placebo for six months. Assessments were conducted throughout the study using a number of tools, including the Neuropsychiatric Inventory (NPI) to measure changes in hallucinations, anxiety and delusions; the Clinician Assessment of Fluctuation (CAF) to measure the frequency and duration of cognitive fluctuations; the Montreal Cognitive Assessment (MoCA) and Cognitive Drug Research Battery (CDR), which track cognitive performance; and the MDS-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III, an objective assessment of parkinsonism. The SHIMMER study was supported by a grant award from the National Institute on Aging of the National Institutes of Health (NIH) totaling approximately $30 million (R01AG071643) and was conducted in collaboration with James E. Galvin, MD, MPH, director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine and the Lewy Body Dementia Association (LBDA). About Cognition Therapeutics, Inc. Cognition Therapeutics, Inc., is a clinical-stage biopharmaceutical company discovering and developing innovative, small molecule therapeutics targeting age-related degenerative disorders of the central nervous system. We recently completed Phase 2 clinical studies of our lead candidate, zervimesine (CT1812) in dementia with Lewy bodies (DLB), mild-to-moderate Alzheimer’s disease and geographic atrophy secondary to dry AMD. The Phase 2 START Study (NCT05531656) in early Alzheimer’s disease is ongoing. We believe zervimesine can regulate pathways that are impaired in these diseases through its interaction with the sigma-2 receptor, a mechanism that is functionally distinct from other approaches for the treatment of degenerative diseases. More about Cognition Therapeutics and our pipeline can be found at https://cogrx.com. Forward Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release or made during the conference, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding our product candidates, including zervimesine (CT1812), our clinical studies of zervimesine, analyses of the results from clinical studies and any expected or implied clinical benefits, expectations regarding development programs for zervimesine, and expectations that initial clinical results observed with respect to zervimesine will be replicated in later trials are forward-looking statements. These statements, including statements relating to the timing and expected results of our clinical trials involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: competition; our ability to secure new (and retain existing) grant funding; our ability to grow and manage growth, maintain relationships with suppliers and retain our management and key employees; our ability to successfully advance our current and future product candidates through development activities, preclinical studies and clinical trials and costs related thereto; uncertainties inherent in the results of preliminary data, pre-clinical studies and earlier-stage clinical trials being predictive of the results of early or later-stage clinical trials; the timing, scope and likelihood of regulatory filings and approvals, including regulatory approval of our product candidates; changes in applicable laws or regulations; the possibility that we may be adversely affected by other economic, business or competitive factors, including ongoing economic uncertainty; our estimates of expenses and profitability; the evolution of the markets in which we compete; our ability to implement our strategic initiatives and continue to innovate our existing products; our ability to defend our intellectual property; the impacts of ongoing global and regional conflicts on our business, supply chain and labor force; and the risks and uncertainties described more fully in the “Risk Factors” section of our annual and quarterly reports filed with the Securities & Exchange Commission and are available at www.sec.gov. These risks are not exhaustive and we face both known and unknown risks. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Contact Information: Cognition Therapeutics, Inc. [email protected] Mike Moyer (investors) LifeSci Advisors [email protected]
Investor releaseQuarter not tagged2025-11-06Cognition Therapeutics Reports Financial Results for the Third Quarter 2025 and Highlights Progress Across Clinical Programs
GlobeNewswire
Cognition Therapeutics Reports Financial Results for the Third Quarter 2025 and Highlights Progress Across Clinical Programs
- $30 Million Registered Direct Offering Support Next Stage of Development for Zervimesine (CT1812) - - Aligned with U.S. FDA on Registrational Path for Zervimesine - - Expanded Access Program for Dementia with Lewy Bodies Ongoing - PURCHASE, N.Y., Nov. 06, 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 third quarter ended September 30, 2025, and provided a business update. “The $30 million registered direct offering enables us to begin preparations for the next stage of development for zervimesine (CT1812),” stated Lisa Ricciardi, Cognition’s president and CEO. “The alignment we achieved with the FDA on a registrational path in Alzheimer’s disease was an important accomplishment. We were encouraged by the agency’s receptivity to study designs and recruitment strategies that support faster, more cost-effective studies. Looking ahead, we believe the clinical pharmacology and bioavailability studies we are conducting will support all planned registrational programs for zervimesine.” Business and Corporate Highlights Achieved alignment with the FDA on a registration path for zervimesine in Alzheimer’s disease following a productive end-of-Phase 2 meeting; Completed a $30 million registered direct offering of 14,700,000 shares of common stock to institutional investors; Expanded access program of zervimesine in DLB is ongoing; Surpassed 75% enrollment in the Phase 2 ‘START’ study of zervimesine in early Alzheimer’s disease being conducted in collaboration with the Alzheimer’s Clinical Trials Consortium (ACTC); Executing required clinical pharmacology and bioavailability studies to prepare zervimesine for the next stage of development across indications; and Proposed registrational Alzheimer’s disease study design accepted for presentation at Clinical Trials in Alzheimer’s Disease (CTAD) Conference, being held December 1-4, 2025. Third Quarter 2025 Financial Results Cash, cash equivalents, and restricted cash equivalents as of September 30, 2025 were approximately $39.8 million and total obligated grant funds remaining from the National Institute of Aging, a division of the National Institute of Health were $36.3 million. The Company estimates that it has sufficient cash to fund operations…Read full documentShow less
- $30 Million Registered Direct Offering Support Next Stage of Development for Zervimesine (CT1812) - - Aligned with U.S. FDA on Registrational Path for Zervimesine - - Expanded Access Program for Dementia with Lewy Bodies Ongoing - PURCHASE, N.Y., Nov. 06, 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 third quarter ended September 30, 2025, and provided a business update. “The $30 million registered direct offering enables us to begin preparations for the next stage of development for zervimesine (CT1812),” stated Lisa Ricciardi, Cognition’s president and CEO. “The alignment we achieved with the FDA on a registrational path in Alzheimer’s disease was an important accomplishment. We were encouraged by the agency’s receptivity to study designs and recruitment strategies that support faster, more cost-effective studies. Looking ahead, we believe the clinical pharmacology and bioavailability studies we are conducting will support all planned registrational programs for zervimesine.” Business and Corporate Highlights Achieved alignment with the FDA on a registration path for zervimesine in Alzheimer’s disease following a productive end-of-Phase 2 meeting; Completed a $30 million registered direct offering of 14,700,000 shares of common stock to institutional investors; Expanded access program of zervimesine in DLB is ongoing; Surpassed 75% enrollment in the Phase 2 ‘START’ study of zervimesine in early Alzheimer’s disease being conducted in collaboration with the Alzheimer’s Clinical Trials Consortium (ACTC); Executing required clinical pharmacology and bioavailability studies to prepare zervimesine for the next stage of development across indications; and Proposed registrational Alzheimer’s disease study design accepted for presentation at Clinical Trials in Alzheimer’s Disease (CTAD) Conference, being held December 1-4, 2025. Third Quarter 2025 Financial Results Cash, cash equivalents, and restricted cash equivalents as of September 30, 2025 were approximately $39.8 million and total obligated grant funds remaining from the National Institute of Aging, a division of the National Institute of Health were $36.3 million. The Company estimates that it has sufficient cash to fund operations and capital expenditures into the second quarter of 2027. Research and development expenses were $3.8 million for the quarter ended September 30, 2025, compared to $11.4 million for the comparable period in 2024. The change in research and development expenses was driven by the completion of SHINE and SHIMMER clinical trials and associated professional fees. General and administrative expenses were $2.6 million for the quarter ended September 30, 2025, compared to $3.1 million for the comparable period in 2024. The change in general and administrative expenses was driven primarily by reduced stock-based compensation expenses. The Company reported a net loss of $4.9 million, or $(0.06) per basic and diluted share for the quarter ended September 30, 2025, compared to a net loss of $9.9 million, or $(0.25) per basic and diluted share for the same period in 2024. About Cognition Therapeutics, Inc. Cognition Therapeutics, Inc., is a clinical-stage biopharmaceutical company discovering and developing innovative, small molecule therapeutics targeting age-related degenerative disorders of the central nervous system. We completed Phase 2 studies of our lead candidate, zervimesine (CT1812) in dementia with Lewy bodies (DLB), mild-to-moderate Alzheimer’s disease and geographic atrophy secondary to dry AMD. The Phase 2 START study (NCT05531656) in early Alzheimer’s disease is ongoing with $81 million in grant support from the National Institute of Aging (NIA) at the National Institutes of Health. We believe zervimesine can regulate pathways that are impaired in these diseases though its interaction with the sigma-2 receptor, a mechanism that is functionally distinct from other approaches for the treatment of degenerative diseases. More about Cognition Therapeutics and our pipeline can be found at https://cogrx.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release or made during the conference call, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements related to our cash runway, our clinical studies of zervimesine (CT1812), and any analysis of the results therefrom; any expected or implied benefits or results of zervimesine, including that initial clinical results observed with respect to zervimesine will be replicated in later trials and our clinical development plans, and our plans for regulatory approval, including our Phase 3 programs for zervimesine and registrational path for zervimesine in Alzheimer’s disease and across indications, are forward-looking statements. These statements, including statements relating to the timing and expected results of our clinical trials involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: competition; our ability to secure new (and retain existing) grant funding; our ability to grow and manage growth, maintain relationships with suppliers and retain our management and key employees; our ability to successfully advance our current and future product candidates through development activities, preclinical studies and clinical trials and costs related thereto; uncertainties inherent in the results of preliminary data, pre-clinical studies and earlier-stage clinical trials being predictive of the results of early or later-stage clinical trials; the timing, scope and likelihood of regulatory filings and approvals, including regulatory approval of our product candidates; changes in applicable laws or regulations; the possibility that we may be adversely affected by other economic, business or competitive factors, including ongoing economic uncertainty; our estimates of expenses and profitability; the evolution of the markets in which we compete; our ability to implement our strategic initiatives and continue to innovate our existing products; our ability to defend our intellectual property; the impacts of global political changes and global economic conditions, supply chain and labor force; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; and the risks and uncertainties described more fully in the “Risk Factors” section of our annual and quarterly reports filed with the Securities & Exchange Commission and are available at www.sec.gov. These risks are not exhaustive and we face both known and unknown risks. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. This press release was published by a CLEAR® Verified individual.
Investor releaseQuarter not tagged2025-08-08Cognition Therapeutics Reports Financial Results for the Second Quarter 2025 and Highlights Progress Across Clinical Programs
GlobeNewswire
Cognition Therapeutics Reports Financial Results for the Second Quarter 2025 and Highlights Progress Across Clinical Programs
- Discussed plans to support a pivotal Alzheimer’s disease program with FDA at end-of-phase 2 meeting - - Initiated expanded access program (EAP) for people with dementia with Lewy bodies (DLB) - - Surpassed 50% enrollment in Phase 2 ‘START’ study of zervimesine in early Alzheimer’s disease - PURCHASE, N.Y., Aug. 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 second quarter ended June 30, 2025, and provided a business update. “The second quarter of 2025 has been very productive, with milestones from each of our clinical programs,” stated Lisa Ricciardi, Cognition’s president and CEO. “These accomplishments highlight the potential for zervimesine to slow the progression of age-related degenerative diseases such as Alzheimer’s disease, dementia with Lewy bodies (DLB) and dry age-related macular degeneration (dry AMD). The clinical findings from each program have been supplemented by the publication of proteomic analyses and in vitro studies that support the mechanism of action of zervimesine in these patient populations.” Business and Corporate Highlights Conducted productive EOP2 meeting with FDA to review results from the Phase 2 ‘SHINE’ study of zervimesine (CT1812) in Alzheimer’s disease; Surpassed 50% enrollment in the Phase 2 study of zervimesine in early Alzheimer’s disease, which is being conducting in partnership with colleagues at the Alzheimer’s Clinical Trials Consortium (ACTC); Reported positive topline results from Phase 2 dry AMD study showing 28.6% reduction of geographic atrophy (GA) lesion growth at 18 months with once-daily oral zervimesine treatment compared to placebo; Received philanthropic donation to support EAP for former Phase 2 ‘SHIMMER’ participants and other patients with DLB; onboarded three clinical sites; Presented results from Phase 2 ‘SHIMMER’ study of zervimesine in DLB at the Alzheimer’s Association International Congress (AAIC) on July 29th in Toronto, Canada; Applied to FDA for breakthrough designation for zervimesine in DLB; Submitted comprehensive manuscript describing proposed mechanism of action of zervimesine in the treatment of dry AMD / GA to peer-reviewed journal; Published proteomics analysis from the Phase 2 ‘SEQUEL’ COG0202 study show…Read full documentShow less
- Discussed plans to support a pivotal Alzheimer’s disease program with FDA at end-of-phase 2 meeting - - Initiated expanded access program (EAP) for people with dementia with Lewy bodies (DLB) - - Surpassed 50% enrollment in Phase 2 ‘START’ study of zervimesine in early Alzheimer’s disease - PURCHASE, N.Y., Aug. 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 second quarter ended June 30, 2025, and provided a business update. “The second quarter of 2025 has been very productive, with milestones from each of our clinical programs,” stated Lisa Ricciardi, Cognition’s president and CEO. “These accomplishments highlight the potential for zervimesine to slow the progression of age-related degenerative diseases such as Alzheimer’s disease, dementia with Lewy bodies (DLB) and dry age-related macular degeneration (dry AMD). The clinical findings from each program have been supplemented by the publication of proteomic analyses and in vitro studies that support the mechanism of action of zervimesine in these patient populations.” Business and Corporate Highlights Conducted productive EOP2 meeting with FDA to review results from the Phase 2 ‘SHINE’ study of zervimesine (CT1812) in Alzheimer’s disease; Surpassed 50% enrollment in the Phase 2 study of zervimesine in early Alzheimer’s disease, which is being conducting in partnership with colleagues at the Alzheimer’s Clinical Trials Consortium (ACTC); Reported positive topline results from Phase 2 dry AMD study showing 28.6% reduction of geographic atrophy (GA) lesion growth at 18 months with once-daily oral zervimesine treatment compared to placebo; Received philanthropic donation to support EAP for former Phase 2 ‘SHIMMER’ participants and other patients with DLB; onboarded three clinical sites; Presented results from Phase 2 ‘SHIMMER’ study of zervimesine in DLB at the Alzheimer’s Association International Congress (AAIC) on July 29th in Toronto, Canada; Applied to FDA for breakthrough designation for zervimesine in DLB; Submitted comprehensive manuscript describing proposed mechanism of action of zervimesine in the treatment of dry AMD / GA to peer-reviewed journal; Published proteomics analysis from the Phase 2 ‘SEQUEL’ COG0202 study showing the impact of zervimesine on key cellular functions in Alzheimer’s disease. “Later this month we anticipate receiving the FDA’s minutes from our end-of-Phase 2 meeting regarding registrational plans for zervimesine in Alzheimer’s disease. We expect these will confirm our understanding of the Agency's expectations for a clinical program in Alzheimer’s disease,” added Ms. Ricciardi. “In addition, we expect FDA will have a decision on breakthrough designation for zervimesine in DLB in the third quarter 2025. We expect these milestones will be valuable to potential partners as we continue to evaluate our options to support development of zervimesine.” Second Quarter 2025 Financial Results Cash, cash equivalents, and restricted cash equivalents as of June 30, 2025 were approximately $11.6 million and total obligated grant funds remaining from the National Institute of Aging, a division of the National Institute of Health were $41.9 million. The Company estimates that it has sufficient cash to fund operations and capital expenditures into the second quarter of 2026. Research and development expenses were $11.5 million for the quarter ended June 30, 2025, compared to $11.6 million for the comparable period in 2024. The change in research and development expenses was primarily driven by a decrease in professional fees. General and administrative expenses were $2.5 million for the quarter ended June 30, 2025, compared to $3.1 million for the comparable period in 2024. The change in general and administrative expenses was driven primarily by reduced stock-based compensation expenses. The Company reported a net loss of $6.7 million, or $(0.11) per basic and diluted share for the quarter ended June 30, 2025, compared to a net loss of $7.0 million, or $(0.18) per basic and diluted share for the same period in 2024. About Cognition Therapeutics, Inc. Cognition Therapeutics, Inc., is a clinical-stage biopharmaceutical company discovering and developing innovative, small molecule therapeutics targeting age-related degenerative disorders of the central nervous system. We recently completed Phase 2 studies of our lead candidate, zervimesine (CT1812) in dementia with Lewy bodies (DLB), mild-to-moderate Alzheimer’s disease and geographic atrophy secondary to dry AMD. The Phase 2 START study (NCT05531656) in early Alzheimer’s disease is ongoing with $81 million in grant support from the National Institute of Aging (NIA) at the National Institutes of Health. We believe zervimesine can regulate pathways that are impaired in these diseases though its interaction with the sigma-2 receptor, a mechanism that is functionally distinct from other approaches for the treatment of degenerative diseases. More about Cognition Therapeutics and our pipeline can be found at https://cogrx.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release or made during the conference call, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements related to our cash runway, our clinical studies of zervimesine (CT1812), and any analysis of the results therefrom; any expected or implied benefits or results of zervimesine, including that initial clinical results observed with respect to zervimesine will be replicated in later trials and our clinical development plans, and our plans for regulatory approval, including our expectations regarding the results and timing of the end-of-Phase 2 meeting for Alzheimer’s disease and the FDA’s review of breakthrough designation for zervimesine in DLB, are forward-looking statements. These statements, including statements relating to the timing and expected results of our clinical trials involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: competition; our ability to secure new (and retain existing) grant funding; our ability to grow and manage growth, maintain relationships with suppliers and retain our management and key employees; our ability to successfully advance our current and future product candidates through development activities, preclinical studies and clinical trials and costs related thereto; uncertainties inherent in the results of preliminary data, pre-clinical studies and earlier-stage clinical trials being predictive of the results of early or later-stage clinical trials; the timing, scope and likelihood of regulatory filings and approvals, including regulatory approval of our product candidates; changes in applicable laws or regulations; the possibility that we may be adversely affected by other economic, business or competitive factors, including ongoing economic uncertainty; our estimates of expenses and profitability; the evolution of the markets in which we compete; our ability to implement our strategic initiatives and continue to innovate our existing products; our ability to defend our intellectual property; the impacts of global political changes and global economic conditions, supply chain and labor force; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; and the risks and uncertainties described more fully in the “Risk Factors” section of our annual and quarterly reports filed with the Securities & Exchange Commission and are available at www.sec.gov. These risks are not exhaustive and we face both known and unknown risks. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. This press release was published by a CLEAR® Verified individual.
Investor releaseQuarter not tagged2025-07-10Cognition Therapeutics Conducts Meeting With US FDA to Review Phase 2 Study Results of Zervimesine
MT Newswires
Cognition Therapeutics Conducts Meeting With US FDA to Review Phase 2 Study Results of Zervimesine
Cognition Therapeutics (CGTX) said Thursday that it met with the US Food and Drug Administration to
Investor releaseQuarter not tagged2025-05-08Cognition Therapeutics Reports Topline Results Showing Oral Zervimesine (CT1812) Reduced Lesion Growth in Phase 2 Study in Geographic Atrophy
GlobeNewswire
Cognition Therapeutics Reports Topline Results Showing Oral Zervimesine (CT1812) Reduced Lesion Growth in Phase 2 Study in Geographic Atrophy
Zervimesine treatment slowed the rate of GA lesion growth by 28.6% compared to placebo Observed GA lesion area was reduced by 28.2% at 18 months compared to placebo Dry AMD results validate zervimesine’s potential across degenerative disease indications PURCHASE, N.Y., May 08, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, reported topline results today from the Phase 2 COG2201 ‘MAGNIFY’ trial of zervimesine (CT1812) in adults with geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD). The results show zervimesine-treated participants had 28.6% slower GA lesion growth on average and at 18 months, their lesions were 28.2% smaller compared to placebo. The MAGNIFY study (NCT05893537) was concluded, after approximately 100 of the planned 246 participants were enrolled. “To date, we have observed evidence of robust slowing of disease progression with zervimesine treatment in Phase 2 studies in Alzheimer’s disease and dementia with Lewy bodies,” explained Anthony O. Caggiano, MD, PhD, Cognition Therapeutics’ chief medical officer and head of R&D. “These results in dry AMD represent yet another indication in which zervimesine has potential to slow the progression of disease with a once-daily oral pill. Compared to current treatment options, which require regular clinic visits for intravitreal injections, an effective oral treatment that patients can take at home would be truly transformative.” GA is characterized by the formation of lesions composed of dead retinal cells and undegraded waste proteins, creating blind spots in central vision. The change in GA lesions was measured using two methods: growth rate and size. Growth rate: in MAGNIFY, a slope analysis showed that the trajectory of GA had slowed by 28.6% in participants treated with zervimesine. Size: at 18 months, the mean lesion size for zervimesine-treated participants was 28.2% smaller than placebo-treated. See Figure 1. We believe these topline results compare favorably to published data from approved injectable complement inhibitors. Approximately 2/3 of patients completed 12 months of dosing and 1/3 completed 18 months of dosing. Additional data, including safety, demographics, and visual and anatomic outcomes are still being analyzed and will be reported at a…Read full documentShow less
Zervimesine treatment slowed the rate of GA lesion growth by 28.6% compared to placebo Observed GA lesion area was reduced by 28.2% at 18 months compared to placebo Dry AMD results validate zervimesine’s potential across degenerative disease indications PURCHASE, N.Y., May 08, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, reported topline results today from the Phase 2 COG2201 ‘MAGNIFY’ trial of zervimesine (CT1812) in adults with geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD). The results show zervimesine-treated participants had 28.6% slower GA lesion growth on average and at 18 months, their lesions were 28.2% smaller compared to placebo. The MAGNIFY study (NCT05893537) was concluded, after approximately 100 of the planned 246 participants were enrolled. “To date, we have observed evidence of robust slowing of disease progression with zervimesine treatment in Phase 2 studies in Alzheimer’s disease and dementia with Lewy bodies,” explained Anthony O. Caggiano, MD, PhD, Cognition Therapeutics’ chief medical officer and head of R&D. “These results in dry AMD represent yet another indication in which zervimesine has potential to slow the progression of disease with a once-daily oral pill. Compared to current treatment options, which require regular clinic visits for intravitreal injections, an effective oral treatment that patients can take at home would be truly transformative.” GA is characterized by the formation of lesions composed of dead retinal cells and undegraded waste proteins, creating blind spots in central vision. The change in GA lesions was measured using two methods: growth rate and size. Growth rate: in MAGNIFY, a slope analysis showed that the trajectory of GA had slowed by 28.6% in participants treated with zervimesine. Size: at 18 months, the mean lesion size for zervimesine-treated participants was 28.2% smaller than placebo-treated. See Figure 1. We believe these topline results compare favorably to published data from approved injectable complement inhibitors. Approximately 2/3 of patients completed 12 months of dosing and 1/3 completed 18 months of dosing. Additional data, including safety, demographics, and visual and anatomic outcomes are still being analyzed and will be reported at a later date. In addition, Cognition plans to submit complete findings for presentation at a medical meeting later this year. “Dry AMD is now the third indication in which we have shown efficacy signals with a once-daily oral drug,” added Lisa Ricciardi, Cognition Therapeutics’ president and CEO. “We believe zervimesine has the potential to be used as a monotherapy or in combination with existing medications. This would allow physicians the flexibility to tailor treatment regimens for their patients. Importantly it would also allow patients who are not appropriate for injectables to have access to treatment. With the right partner and development plan, we believe zervimesine could be a treatment breakthrough in these large, underserved diseases.” About the MAGNIFY Study (COG2201) The MAGNIFY study was a double-masked, placebo-controlled Phase 2 clinical trial designed to enroll 246 adults with geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD). Participants were evenly randomized to receive either placebo or 200 mg of once-daily oral zervimesine. The MAGNIFY study was concluded after approximately 100 of the planned 246 participants were enrolled. Participants in MAGNIFY were assessed for safety and tolerability, changes in GA lesion size and growth rate, changes in visual acuity and other anatomic and visual measures. The decision to voluntarily conclude the MAGNIFY study prior to its intended enrollment goal has allowed the Company to focus resources on its ongoing programs in Alzheimer’s and DLB. About Geographic Atrophy Secondary to Dry AMD Dry AMD is the more prevalent of two forms of age-related macular degeneration and accounts for up to 90% of cases. Dry AMD is caused by damage and loss of light-sensing cells in the macula, the part of the retina responsible for central vision. The gradual loss of central vision associated with dry AMD can present limitations in reading and driving. As the disease progresses in severity to geographic atrophy, lesions form on the macula that create a blind spot in central vision. These lesions grow over time leading to irreversible loss of central vision. About Zervimesine (CT1812) Zervimesine (CT1812) is an investigational oral, once-daily pill being developed for the treatment of CNS diseases such as Alzheimer’s disease and dementia with Lewy bodies (DLB). While these diseases have different symptoms, both are associated with the buildup of certain proteins in the brain - Aβ and ɑ-synuclein. As these proteins bind to neurons, they can damage and ultimately destroy the neurons. This results in a progressive loss in a person’s ability to learn, recall memories, move efficiently, or communicate. These diseases progress relentlessly and ultimately result in death. If zervimesine can interrupt the toxic effects of these proteins, it may be able to slow progression of disease and improve the lives of those suffering from Alzheimer’s and DLB. Zervimesine has been generally well tolerated in clinical studies to date. The USAN Council has adopted zervimesine as the United States Adopted Name (USAN) for CT1812. About Cognition Therapeutics, Inc. Cognition Therapeutics, Inc., is a clinical-stage biopharmaceutical company discovering and developing innovative, small molecule therapeutics targeting age-related degenerative disorders of the central nervous system. We are currently investigating our lead candidate, zervimesine (CT1812), in clinical programs in dementia with Lewy bodies (DLB) and Alzheimer’s disease, including the ongoing START study (NCT05531656) in early Alzheimer’s disease. We believe zervimesine can regulate pathways that are impaired in these diseases though its interaction with the sigma-2 receptor, a mechanism that is functionally distinct from other approaches for the treatment of degenerative diseases. More about Cognition Therapeutics and our pipeline can be found at https://cogrx.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding our expected runway, product candidates, including zervimesine (CT1812), and any expected or implied benefits or results, including that initial clinical results observed with respect to zervimesine will be replicated in later trials and our clinical development plans, and expectations regarding timing, success and data announcements of current ongoing clinical trials are forward-looking statements. These statements, including statements relating to the timing and expected results of our clinical trials involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: competition; our ability to secure new (and retain existing) grant funding; our ability to grow and manage growth, maintain relationships with suppliers and retain our management and key employees; our ability to successfully advance our current and future product candidates through development activities, preclinical studies and clinical trials and costs related thereto; uncertainties inherent in the results of preliminary data, pre-clinical studies and earlier-stage clinical trials being predictive of the results of early or later-stage clinical trials; the timing, scope and likelihood of regulatory filings and approvals, including regulatory approval of our product candidates; changes in applicable laws or regulations; the possibility that the we may be adversely affected by other economic, business or competitive factors, including ongoing economic uncertainty; our estimates of expenses and profitability; the evolution of the markets in which we compete; our ability to implement our strategic initiatives and continue to innovate our existing products; our ability to defend our intellectual property; impacts of global political changes and global economic conditions on our business, supply chain and labor force; our ability to maintain the listing of our common stock on the Nasdaq Global Market; and the risks and uncertainties described more fully in the “Risk Factors” section of our annual and quarterly reports filed with the Securities Exchange Commission and are available at www.sec.gov. These risks are not exhaustive, and we face both known and unknown risks. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d62491cf-a8af-4386-87f7-a6f4b98c2c4f This press release was published by a CLEAR® Verified individual.

