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

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

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 ...

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]

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. ...

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 ...

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 ...

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 ...

Masked Analysis Shows Participants Receiving Oral Zervimesine for at Least 6 Months Experienced Slower Lesion Growth than Participants Receiving Placebo Following the Futility Analysis, Management Concluded the Phase 2 Study, Preserving Capital Full Analysis will be Provided in the Second Quarter of 2025 PURCHASE, N.Y., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, reported a positive outcome o ...

Core Insights - Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing drugs for neurodegenerative disorders, particularly Alzheimer's disease and dementia with Lewy bodies [4] Group 1: Workshop and Presentation - Dr. Mary Hamby will co-host a precision medicine workshop at the Hanson Wade Neuroimmunology Drug Development Summit, focusing on participant screening methods for clinical trials [1] - The workshop will include an overview of findings from Cognition's Phase 2 'SHINE' study of zervimesine (CT1812), highlighting that participants with lower p-tau217 levels showed a 95% improvement on the ADAS-Cog 11 scale and a 108% improvement on the MMSE scale compared to placebo [2][3] Group 2: Diagnostic Potential - Plasma p-tau217 assays are suggested to be valuable not only as a diagnostic tool but also for identifying Alzheimer's patients who are most likely to benefit from therapies targeting beta amyloid [3] - The measurement of plasma p-tau217 can be conducted through a simple blood test, aiding in the personalization of treatment regimens for patients [3] Group 3: Company Overview - Cognition Therapeutics is currently investigating zervimesine in clinical programs for dementia with Lewy bodies and Alzheimer's disease, including the ongoing START study in early Alzheimer's disease [4] - Zervimesine is believed to interact with the sigma-2 receptor, offering a distinct mechanism for treating degenerative diseases [4]