Cognition Therapeutics(US:CGTX)2025-03-20 20:11Financial 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]