• Cash and Cash Equivalents: Approximately $25 million as of December 31, 2024.
• Total Obligated Grant Funds: $50 million remaining from the NIA.
• Research and Development Expenses: $41.7 million for the year ended December 31, 2024, up from $37.2 million in 2023.
• General and Administrative Expenses: $12.3 million for the year ended December 31, 2024, down from $13.5 million in 2023.
• Net Loss: $34 million or $0.86 per basic and diluted share for the year ending December 31, 2024, compared to a net loss of $25.8 million or $0.86 per share in 2023.
• ATM Facility Proceeds: Sold almost 20 million shares for gross proceeds of approximately $12.8 million.

• Warning! GuruFocus has detected 2 Warning Signs with CGTX.

Release Date: March 20, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Cognition Therapeutics Inc (NASDAQ:CGTX) reported strong efficacy signals from studies on zervimesine for Alzheimer's and dementia with Lewy bodies (DLB), indicating potential value for patients and investors.
• The company has strategically prioritized its resources by concluding the dry AMD study, allowing full focus on Alzheimer's and DLB programs.
• Cognition Therapeutics Inc (NASDAQ:CGTX) has developed a novel chemical process for manufacturing zervimesine, with provisional patent applications filed, supporting future clinical and commercial needs.
• The company has an active business development program and is exploring partnerships to secure non-dilutive funding for its clinical development efforts.
• Cognition Therapeutics Inc (NASDAQ:CGTX) has sufficient cash to fund operations into the fourth quarter of 2025, supported by a $50 million balance in obligated grant funds from the NIA.

Negative Points

• Cognition Therapeutics Inc (NASDAQ:CGTX) faces significant capital requirements to fund its Alzheimer's and DLB studies, with no guaranteed partnerships or funding deals confirmed yet.
• The company reported a net loss of $34 million for 2024, an increase from the previous year's loss of $25.8 million.
• Cognition Therapeutics Inc (NASDAQ:CGTX) needs to regain compliance with Nasdaq's minimum bid requirement by September 8, 2025, to avoid delisting.
• The decision to conclude the dry AMD study, despite passing a futility analysis, may raise concerns about the company's ability to manage multiple programs simultaneously.
• There is uncertainty around the exact dosing strategy for pivotal studies, as the company has not yet finalized the dose for zervimesine in Alzheimer's and DLB trials.

Q & A Highlights

Q: As you prepare for the end of Phase 2 FDA meeting, do you have any thoughts on the tau cutoff threshold based on the SHINE study learnings? Also, any updates on enrollment for the early AD study? A: Tony Caggiano, Chief Medical Officer, stated that they plan to enrich participants in the next study for those with lower tau levels, similar to the SHINE study. However, no specific number has been announced yet. The early AD study is still recruiting, and there is no tau cutoff in that study as it targets an early-stage Alzheimer's population.

Q: Regarding the SHIMMER data presented at a recent conference, can you share any feedback from investigative physicians and your publication strategy? Also, how does corporate development activity look like for potential partnerships? A: Lisa Ricciardi, CEO, mentioned receiving strong feedback from KOLs, neurologists, and payers, highlighting the drug's convenience and safety profile. The publication process is underway, and they are exploring various partnership options, though no specific updates are available yet.

Q: For the DLB program, are you considering any biomarkers to increase the probability of success in pivotal studies? A: Tony Caggiano stated that there is no definitive enrichment strategy for DLB as they observed a robust response across all recruited participants, regardless of various factors such as age, gender, and medication status.

Q: What are your thoughts on dosing for pivotal studies in AD and DLB, and what dose are you considering? A: Tony Caggiano indicated that they are likely to use doses below 300 milligrams, as both 100- and 300-milligram doses showed similar robust responses. The exact dose will be determined after the end of Phase 2 meeting with the FDA.

Q: What does the competitive landscape in DLB look like, and what are your thoughts on the potential approvability of zervimesine based on neuropsychiatric parameters? A: Tony Caggiano emphasized the importance of neuropsychiatric symptoms in DLB and mentioned that the FDA meeting will focus on outcome measures and study design. They are confident in the interest from physicians and the FDA.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.