Cognition Therapeutics, Inc.

Greetings, and welcome to the Cognition Therapeutics fourth quarter and full year 2024 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Mike Moyer, with LifeSci Advisors. Thank you. You may begin.

Thank you, operator, and good morning, everyone. Welcome to Cognition Therapeutics' fourth quarter and year-end 2024 results conference call. With me today are Lisa Ricciardi, President and Chief Executive Officer, John Doyle, Chief Financial Officer, and Dr. Tony Caggiano, Chief Medical Officer. This morning, the company issued a press release detailing its 2024 fourth quarter and year-end results. We encourage everyone to read this morning's press release as well as Cognition's annual report and Form 10-K, which is now filed with the SEC and available on our website. In addition, this conference call is being webcast through the company's website and will be archived for 30 days. Please note that certain information discussed on the call today is covered under the safe harbor provisions of the Private Securities Litigation Reform Act. We caution listeners that during this call management will be making forward looking statements. Actual results could differ materially from those stated or implied by these forward looking statements due to the risks and uncertainties associated with the company's business. These forward-looking statements are qualified by the cautionary statements contained in Cognition's press releases and SEC filings, including its annual report on Form 10-K and previous filings. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast. Cognition undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. With that, I would like to now hand the call over to Lisa Ricciardi.

Mike, thank you, and good morning, everyone. Cognition Therapeutics focus is the development of Zervimicine for patients with Alzheimer's disease and dementia with Lewy bodies, which I'll refer to as DLB. For clarity, Zervimicine is the USAN or the generic name for our lead candidate, CT1812. Last year, we reported data from two studies in both patient populations, and the results showed strong efficacy signals making it clear that cervimicine has the potential to bring great value to patients and their care partners, and we believe to investors as well. Many of you are wondering what are the next steps to advance cervimicine into registrational trials. Our clinical operations and development teams are working to prepare final study documents from both trials. To be clear, these are very large dossiers. They need to be compiled, reviewed, and cross-checked. And when we're satisfied with these documents, we will submit them to the FDA along with requests for two different end-of-phase II meetings, one for Alzheimer's and one for DLB. At the same time, we're having discussions with advisors to ensure that we are as prepared as possible when approaching the FDA. Now let's talk about capital allocation. We decided to conclude our dry AMD phase two dry AMD study before its completion. The reduced expense extends our runway and now 100% of our attention and resources are allocated to our Alzheimer's and DLB programs. Let me be clear, the decision to conclude the dry AMD study was not due to any safety concerns. Quite the contrary, our clinical research organization partner conducted an analysis of the mask data. This type of analysis is referred to as a futility study, and it is used to determine if an experimental drug has signals of efficacy during a clinical trial. We reported that we had indeed passed the analysis, which supports the potential of Zervimicine in patients with dry AMD. However, We felt then, and we still believe, that the decision to conclude the DRY-AMD study was necessary for the success of our Alzheimer's and DLB programs. Darimacine has shown clear activity in these two large patient populations, and there is such a clear need for new, effective, convenient drugs in both Alzheimer's and Lewy body dementia. Therefore, we intend to discuss with the FDA plans to pursue each indication in separate studies. Now, we are not naive about the significant capital needed to fund these studies. We have an active business development program ongoing. We've built strong relationships with biotech and pharma players in this space since we began as a company. We have conducted a number of fruitful meetings since the beginning of the year, updating interested parties on the data from Shine and Shimmer. The ideal scenario would be to find a partner to work with on the development and registration program, and in the process, obtain non-dilutive funding for one or both indications. There's nothing I can confirm today, and I have no guarantee that we're going to sign a deal, but I am confident we will find a path forward with funding. We are evaluating all our options to finance our clinical development efforts. In addition, beyond securing capital, we're making strides to ensure we're Phase III ready. Our CMC team has developed a novel chemical process for the manufacture of zirvimicine. Provisional patent applications covering this chemical process have been filed. We expect that this manufacturing process will produce material sufficient for future clinical studies, and if zirvimicine is approved, we expect it will support commercial manufacturing needs. On that same front, we're working with a domestic CMO or contract manufacturing organization that will be capable of producing commercial quantities of Zervimicine. With that, John Doyle will review our financial results and provide color around our cash position and capital requirements. John?