Summary of Cognition Therapeutics FY Conference Call Company Overview - **Company**: Cognition Therapeutics (NasdaqGM: CGTX) - **Focus**: Development of zervimesine for neurodegenerative diseases, particularly Alzheimer's disease and Lewy body dementia Key Points Zervimesine Mechanism and Clinical Programs - **Mechanism of Action**: Zervimesine is designed to block toxic oligomers by binding to TMEM97 and PGRMC1 proteins on neurons, leading to reduced binding affinity of oligomers and restoration of synaptic health [4][5] - **Clinical Focus**: The drug is being investigated for dementia with Lewy bodies (DLB) and Alzheimer's disease, with overlapping pathologies noted between the two conditions [7][8] - **Current Management of DLB**: There are no approved treatments for DLB, leading to a reliance on off-label medications, which often results in a lengthy and complicated diagnosis process [9][10] Clinical Trial Insights - **SHIMMER Study Outcomes**: The study showed benefits across cognitive, functional, and behavioral domains, with the strongest effects observed in neuropsych symptoms [11][12] - **FDA Engagement**: Cognition Therapeutics is preparing for a Type C meeting with the FDA to discuss endpoints for a potential phase 3 trial, emphasizing the importance of activities of daily living (ADLs) in evaluating efficacy [13][16] - **Alzheimer's SHINE Study**: The study focused on patients with lower p-tau217 burden, showing significant slowing of disease progression, with a 95% reduction in disease progression observed in half of the patients [22][30] Regulatory and Development Strategy - **Regulatory Strategy**: The FDA has encouraged the company to enrich the patient population for those with lower p-tau levels and to use a single dose for trials [35][36] - **Trial Design Considerations**: The company is evaluating whether to conduct one six-month trial or a longer trial to capture the drug's efficacy effectively [37][40] Safety and Tolerability - **Safety Profile**: Zervimesine has shown a favorable safety profile, with serious adverse events lower than in the placebo group. Liver function tests are monitored, but changes are reversible [53][54] Future Directions - **Potential for Other Conditions**: There is interest in exploring zervimesine for other neurodegenerative conditions, including Parkinson's disease and multisystem atrophy [58] Additional Insights - **Patient Experience**: The variability in symptoms and the impact of cognitive decline on daily life were highlighted, emphasizing the need for effective treatments [11][12] - **Market Positioning**: The company aims to position zervimesine as a disease-modifying drug, addressing both cognitive and behavioral symptoms in patients with Alzheimer's and DLB [12][18] This summary encapsulates the critical discussions and insights from the Cognition Therapeutics FY Conference Call, focusing on the company's strategic direction, clinical findings, and regulatory interactions.

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]