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Cognition Therapeutics to Report Biomarker Results from Phase 2 SHINE Study in Mild-to-Moderate Alzheimer’s Disease in Podium Presentation at AD/PD 2025
Globenewswire· 2025-03-25 11:30
Core Insights - Cognition Therapeutics, Inc. will present biomarker results from the Phase 2 SHINE study of zervimesine (CT1812) for Alzheimer's disease at the AD/PD 2025 Conference [1] - The study focuses on key proteins, or biomarkers, associated with Alzheimer's disease progression, including neurofilament light (NfL), glial fibrillary acidic protein (GFAP), amyloid beta (Aβ), and tau species [2] - The analysis aims to provide insights into the impact of zervimesine on disease biology by comparing biomarker changes in participants receiving the drug versus those on placebo [3] Presentation Details - The podium presentation titled "Positive Impact of CT1812 Treatment on Plasma Biomarkers in Lower p-tau217 Subgroup Aligns with Clinical Benefits in Mild-to-Moderate AD Patients" is scheduled for April 1, 2025, at 2:45 PM CET [4] - Additional poster presentations will cover CSF proteomic biomarker analysis, identification of CSF proteins correlating with cognitive outcomes, and molecular correlates with treatment-related decreases in NfL CSF levels [4] Company Overview - Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related neurodegenerative disorders [5] - The lead candidate, zervimesine (CT1812), is being investigated in clinical programs for dementia with Lewy bodies and Alzheimer's disease, including the ongoing START study [5] - The company believes zervimesine can regulate impaired pathways in these diseases through its interaction with the sigma-2 receptor, which is distinct from other treatment approaches [5]
Cognition Therapeutics(CGTX) - 2024 Q4 - Earnings Call Transcript
2025-03-20 20:11
Financial Data and Key Metrics Changes - The company reported a net loss of $34 million or $0.86 per basic and diluted share for the year ended December 31, 2024, compared to a net loss of $25.8 million or $0.86 per basic and diluted share for 2023 [23] - Cash and cash equivalents as of December 31, 2024, were approximately $25 million, with total obligated grant funds remaining from the NIA at $50 million [20] - Research and development expenses increased to $41.7 million for the year ended December 31, 2024, from $37.2 million in 2023, primarily due to higher costs associated with completing two Phase II trials [21] Business Line Data and Key Metrics Changes - The company decided to conclude its Phase II dry AMD study before completion, reallocating resources entirely to Alzheimer's and DLB programs [11][19] - The decision to conclude the dry AMD study was based on prioritizing the success of the Alzheimer's and DLB programs, despite showing potential efficacy in dry AMD [12][13] Market Data and Key Metrics Changes - The company is actively pursuing partnerships for funding and development in the Alzheimer's and DLB space, indicating strong interest from biotech and pharma players [15] - The company has received a 6-month grace period to regain compliance with NASDAQ's minimum bid requirement, needing to maintain a stock price above $1 for 10 consecutive days before September 8, 2025 [24] Company Strategy and Development Direction - The focus remains on advancing zervimesine for Alzheimer's disease and dementia with Lewy bodies, with plans to submit final study documents to the FDA for two different end of Phase II meetings [9][10] - The company is preparing for Phase III readiness and has developed a novel chemical process for zervimesine manufacturing, with provisional patent applications filed [17][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in regaining NASDAQ compliance and highlighted upcoming milestones that could drive stock value [24] - The company is committed to addressing financing challenges while aiming to deliver multiple clinical milestones and create long-term shareholder value [60] Other Important Information - The company has built strong relationships with potential partners and is evaluating all options for financing clinical development efforts [15][16] - The publication process for SHIMMER data is underway, with expectations for release in the coming months [37] Q&A Session Summary Question: Thoughts on tau cutoff threshold for Phase II FDA meeting - Management plans to enrich participants in the next study for those with lower tau, similar to the SHINE study, but has not finalized the specific cutoff [29][30] Question: Feedback from investigative physicians on SHIMMER data - Management received excellent feedback from KOLs and payers, indicating a strong need for zervimesine and appreciation for its safety profile [35] Question: Competitive landscape in DLB and potential approvability - Management is confident that neuropsychiatric symptoms will be of interest to physicians and the FDA, with a focus on determining appropriate outcome measures for studies [49][50] Question: Outlook for accelerated approval in Europe vs. the US - The company plans to follow a traditional pathway for Phase III studies, as the accelerated approval process has been complex and not necessarily easier in Europe [52][53] Question: NIH funding outlook and potential for new grants - The company has a remaining balance of $50 million from NIH funding, which is expected to support ongoing trials, but anticipates lower probability for new grant funding as it progresses to Phase III [54][56]
Cognition Therapeutics(CGTX) - 2024 Q4 - Earnings Call Transcript
2025-03-20 17:15
Financial Data and Key Metrics Changes - The company reported a net loss of $34 million or $0.86 per basic and diluted share for the year ended December 31, 2024, compared to a net loss of $25.8 million or $0.86 per basic and diluted share for 2023 [23] - Cash and cash equivalents as of December 31, 2024, were approximately $25 million, with total obligated grant funds remaining from the NIA at $50 million [20][21] - Research and development expenses increased to $41.7 million for the year ended December 31, 2024, from $37.2 million for 2023, primarily due to higher costs associated with completing two Phase II trials [22] Business Line Data and Key Metrics Changes - The company decided to conclude its Phase II dry AMD study before completion, reallocating resources entirely to Alzheimer's and DLB programs [11][19] - The decision to conclude the dry AMD study was based on strategic prioritization rather than safety concerns, as the analysis indicated potential efficacy [12][13] Market Data and Key Metrics Changes - The company is actively pursuing partnerships for funding and development in the Alzheimer's and DLB space, indicating strong interest from biotech and pharma players [15][35] - The company received a 6-month grace period to regain compliance with NASDAQ's minimum bid requirement, needing to maintain a stock price above $1 for 10 consecutive days before September 8, 2025 [24] Company Strategy and Development Direction - The focus remains on advancing zervimesine for Alzheimer's disease and DLB, with plans to submit final study documents to the FDA for two different end of Phase II meetings [10][14] - The company is preparing for Phase III readiness and has developed a novel chemical process for zervimesine manufacturing, with provisional patent applications filed [17][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in regaining NASDAQ compliance and highlighted upcoming milestones that could drive stock value [24][60] - The company is committed to overcoming financing challenges and is focused on delivering multiple clinical milestones to create long-term shareholder value [60] Other Important Information - The company has built strong relationships with potential partners and is evaluating all options for financing clinical development efforts [15][16] - The publication process for SHIMMER data is underway, with expectations for release in the coming months [37] Q&A Session Summary Question: Thoughts on tau cutoff threshold for end of Phase II FDA meeting - Management plans to enrich participants in the next study for those with lower tau, similar to the SHINE study, but has not finalized the specific cutoff [29][30] Question: Feedback from investigative physicians on SHIMMER data - Management received excellent feedback from KOLs and neurologists, indicating a strong need for zervimesine and appreciation for its safety profile [35] Question: Competitive landscape in DLB and potential approvability - Management is confident that neuropsychiatric symptoms will be of interest to the FDA, and they plan to propose specific outcome measures during the FDA meeting [49][50] Question: Outlook for accelerated approval in Europe vs. the US - The company plans to follow a traditional pathway for approval, as the accelerated pathway has shown mixed results in the past [52] Question: NIH funding outlook and potential for new grants - The company has a remaining balance of $50 million from NIH funding, which is expected to support ongoing trials, but anticipates lower probability for new grant funding as it progresses to Phase III [54][56]
Cognition Therapeutics(CGTX) - 2024 Q4 - Annual Report
2025-03-20 11:15
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For The Transition Period From To Commission file number: 001-40886 COGNITION THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 13-4365359 (State of Other ...
Cognition Therapeutics(CGTX) - 2024 Q4 - Annual Results
2025-03-20 11:09
2025 Objective: Advance Zervimesine into Late-stage Trials for DLB and Alzheimer's Disease Management will Review Results at 8:00 a.m. ET on Live Webcast and Conference Call Exhibit 99.1 Cognition Therapeutics Reports Year End 2024 Financial Results and Provides Business Update Positive Results with Zervimesine (CT1812) in Phase 2 SHIMMER Dementia with Lewy Bodies (DLB) Phase 2 SHINE Data Show Dramatic Slowing of Cognitive Decline with Zervimesine in a Key Pre-specified Alzheimer's Disease Subgroup Purchase ...
Cognition Therapeutics Reports Year End 2024 Financial Results and Provides Business Update
Globenewswire· 2025-03-20 11:00
Core Insights - Cognition Therapeutics, Inc. reported positive results from Phase 2 studies of zervimesine (CT1812) for dementia with Lewy bodies (DLB) and Alzheimer's disease, indicating significant potential for these neurodegenerative disorders [1][4][5] - The company plans to advance zervimesine into late-stage trials for both DLB and Alzheimer's disease, with meetings scheduled with the FDA to discuss Phase 3 clinical protocols [3][4] Clinical Developments - Phase 2 SHIMMER study results showed up to 91% slowing of cognitive decline compared to placebo after 6 months of zervimesine treatment in DLB patients [5] - Phase 2 SHINE study results indicated near-total preservation of cognition in Alzheimer's patients with lower p-tau217 levels treated with zervimesine [5] - The company has concluded enrollment in the Phase 2 dry AMD study to focus resources on Alzheimer's and DLB programs [2][7] Financial Overview - As of December 31, 2024, cash and cash equivalents were approximately $25.0 million, with total obligated grant funds remaining from the NIA at $50.0 million [8][16] - Research and development expenses increased to $41.7 million in 2024 from $37.2 million in 2023, primarily due to costs associated with ongoing Phase 2 trials [8][9] - The company reported a net loss of $34.0 million for 2024, compared to a net loss of $25.8 million in 2023, with a consistent loss per share of $(0.86) [9][15] Strategic Initiatives - The company is actively evaluating funding options for clinical trials, including potential partnerships with pharmaceutical companies [4] - A novel chemical process for zervimesine manufacturing has been developed, with provisional patent applications filed as part of the Phase 3 readiness plan [5]
Cognition Therapeutics to Report Fourth Quarter and Full Year 2024 Results
Globenewswire· 2025-03-13 20:05
Conference Call and Live Audio Webcast Scheduled for March 20, 2025PURCHASE, N.Y., March 13, 2025 (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, 2024, on Thursday, March 20, 2025, before the market open. Following the release, management will host a conference call at 8:00 a. ...
Cognition Therapeutics Granted Extension to Meet Nasdaq Minimum Bid Price Requirement for Continued Exchange Listing
Globenewswire· 2025-03-12 20:05
PURCHASE N.Y., March 12, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (Nasdaq: CGTX), a clinical stage company developing product candidates that treat neurodegenerative disorders, (the “Company” or “Cognition”), was notified by the Nasdaq Stock Market LLC (“Nasdaq”) on September 12, 2024 that the bid price of its common stock had closed at less than $1.00 per share over the previous 30 consecutive business days. As a result, Cognition was given 180 calendar days to regain compliance with the minim ...
Cognition Therapeutics to Present at Life Sciences Virtual Investor Conference
Globenewswire· 2025-03-10 11:30
PURCHASE, N.Y., March 10, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the “Company” or “Cognition”) (NASDAQ: CGTX), a clinical stage company developing product candidates that treat neurodegenerative disorders, (the “Company” or “Cognition”), announced that President and CEO Lisa Ricciardi will present live at the Life Sciences Virtual Investor Conference on March 13, 2025 at 9:30 a.m. ET. In her presentation, Ms. Ricciardi will review plans for 2025 to support the advancement of zervimesine (CT ...
Cognition Therapeutics Publishes Research Supporting the Potential of Zervimesine in Dry AMD
Globenewswire· 2025-02-27 12:30
Collaborators at the University of Southampton, UK and Cognition Scientists Show Rescue of Function in a Cell Model of Dry AMDPURCHASE, N.Y., Feb. 27, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (Nasdaq: CGTX), a clinical stage company developing neurodegenerative disease candidates, (the “Company” or “Cognition”) announced the publication of a manuscript reviewing recent work supporting the potential of zervimesine (CT1812), a small molecule drug candidate to treat dry age-related macular degener ...