Cognition Therapeutics, Inc. Q4 FY2024 earnings call

• Focus on developing zervimesine for Alzheimer's disease and DLB. - Concluded the dry AMD Phase II study to allocate resources to Alzheimer's and DLB programs. - Clinical development teams preparing final study documents for FDA submissions. - CMC team developed a novel chemical process for zervimesine manufacturing with provisional patents filed. - NASDAQ granted a 6-month grace period to regain compliance, with milestones like FDA meetings and partnering announcements expected. - Financials for 2024: R&D expenses $41.7M, G&A expenses $12.3M, net loss $34M.

No detailed product segment financial performance with absolute revenue and contribution % provided in the transcript.

• Concluding dry AMD study extends cash runway into Q4 2025. - Plan to submit study documents to FDA and request end of Phase II meetings for Alzheimer's and DLB. - Anticipate announcements on partnering or funding. - Confident in regaining NASDAQ compliance by September 8, 2025.

• Uncertainties in clinical trial outcomes affecting efficacy signals. - Funding challenges for clinical development efforts. - Potential differences between forward-looking statements and actual results due to various risks and uncertainties. - NASDAQ compliance risk if stock doesn't close above $1 for 10 consecutive days by September 8, 2025.

Q: As you prep for the end of Phase II FDA meeting, do you have any latest thoughts on the tau cutoff threshold that you might be thinking about based on the SHINE study learnings? And also if you could comment on implications of that biomarker to the ongoing Phase II early AD study and if there's any update on enrollment for that early AD study would be helpful too?

A: Tony Caggiano said they are planning to do enrichment of participants in the next study for those who have lower tau, similar to SHINE study, but haven't landed on a specific number yet. Relating to the early AD study, it is still continuing to recruit and there is no particular cut around tau in that study as it's a different population at the early end of the spectrum.

Q: On SHIMMER data that was presented at a recent conference, are you able to share any investigative physician feedback that you came away with? And also, interested in what sort of next steps in terms of publication strategy that you may have there in DLB because obviously, not a lot going on there? And if you're able to just maybe update us on how corporate development activity could look like, if it's the same partner interested in both indications or do you think one indication could be more sort of manageable by a company your size versus maybe another indication being pursued by a larger company?

A: Lisa Ricciardi said they don't have updates on partnering but have lots of interest in different forms. They have excellent feedback from KOLs, neurologists, and payers, consistently strong. Publication is already underway. Tony Caggiano added publication preparation is ongoing with a long cycle.

Q: I have one for DLB specifically, similar to the Alzheimer's program, are you looking at any biomarkers or did you find any biomarkers to try to increase the probability of success of that program in the pivotal studies?

A: Tony Caggiano said they don't have any definitive enrichment strategy yet, but saw good robust response across all recruited DLB participants regardless of various factors like age, gender, etc.

Q: With respect to dosing. So when you reported the news about GA, and I think you had a green light for the SMB. Was that for 200-milligram dose? And thinking about the dose for pivotal studies for AD and DLB, what are your current thinking? Are you leaning towards 100 or 200?

A: Tony Caggiano said they haven't selected an exact dose yet, most likely operating below 300 milligrams as data shows nearly identical response for 100 and 300-milligram dose groups, and will explore doses below 300, with details to be announced after end of Phase II meeting.

Q: What does the competitive landscape in DLB look like and recognizing your plans to meet with the FDA regarding zervimesine, what are your thoughts around the potential approvability of it in DLB based on neuropsychiatric parameters? And what are the outlooks in Europe versus the United States for accelerated approval in anti-Alzheimer's drugs? And what are your thoughts for more near- or medium-term grant funding given the reported NIH cutbacks?

A: Tony Caggiano said neuropsychiatric symptoms are key in DLB, and FDA meeting will focus on outcome measures. On Europe vs US accelerated approval, they plan to follow traditional pathway. Lisa Ricciardi said they have $50M balance of NIH funding for START trial, don't anticipate more grant funding for Phase III programs as funding vehicles are geared toward earlier stages.