Cognition Therapeutics, Inc.

Good morning, ladies and gentlemen, and welcome to Cognition Therapeutics Incorporated's fourth quarter and fiscal year 2021 earnings conference call. My name is Livia, and I will be your conference operator today. This call is being recorded. I would now like to turn the presentation over to your speaker host for today's call, Mr. Daniel Contel-Blatang, Investor Relations for Cognition Therapeutics. Please proceed.

Good morning, and thank you for participating in Cognition Therapeutics conference call today. With me today are Lisa Ricciardi, President and Chief Executive Officer of Cognition, and Jim O'Brien, Chief Financial Officer of Cognition. By now, you should have the press release we issued earlier. If not, it is available on the investor relations page of our website at CogRx.com. We encourage everyone to read this morning's press release as well as Cognition's annual report on Form 10-K, which is now filed with the SEC. The company's 10-K report and press release are also available on Cognition's 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 in the call today is covered under the safe harbor provisions of the Private Security 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 risk and uncertainties associated with the company's business. These forward-looking statements are qualified by cautionary statements contained in cognitions, 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 this 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 now like to turn the call to Lisa Ricciardi. Lisa?

Thank you, Daniel. Good morning, everyone, and welcome to Cognition Therapeutics' first earnings conference call. On today's call, our chief financial officer, Jim O'Brien, and I will share prepared remarks on the company's progress and financial performance in 2021, after which we'll be joined by Dr. Tony Caggiano, our CMO and head of R&D, in order to take your questions. It has been an exciting time at Cognition Therapeutics. We completed our initial public offering, which added to our significant base of grant funding. As our team moves forward with intent and velocity to advance our pipeline of drug candidates for serious neurodegenerative conditions, we are well positioned in terms of our access to capital and grants, and our scientific underpinnings are strong. As many of you know, our primary focus is on the development of innovative, orally available drug candidates targeting age-related degenerative diseases of the CNS and retina. Our current clinical programs leverage the company's expertise in the Sigma-2 receptor, which regulates the number of cellular functions that are disrupted in neurodegenerative diseases. Our lead candidate, CT1812, is currently being tested in multiple diseases, such as Alzheimer's and Parkinson's disease, dementia with Lewy bodies, or DLB, and dry age-related macular degeneration, or dry AMD. We believe that modulating the Sigma-2 receptor complex with a brain-penetrant small-molecule drug candidate is an approach that is distinct from other approaches in clinical development. Now, let me turn to some recent data and then provide a short update on our trials. Our initial indication for CT1812 is Alzheimer's disease, and we recently presented data from two studies at the ADPD meeting in Barcelona several weeks ago. First, we presented data from the SNAP study that showed the rapid and robust displacement of A-beta oligomers into the cerebral spinal fluid of patients with mild to moderate Alzheimer's disease following a single dose of CT1812. No such change was observed following the administration of placebo, and we expect to publish complete results later this year. Second, at the ADPD meeting, we presented an analysis of biomarkers from the first part of our Phase II SHINE study. Patients in this first cohort of the study who were treated with CT1812 showed marked changes in the levels of certain proteins implicated in Alzheimer's and Parkinson's disease. Among these, 22 proteins that are dysregulated in Alzheimer's disease were normalized after CT1812 towards levels seen in healthy controls six proteins were specifically implicated in cognition. With our NIA additional funding of $13 million, we believe we will complete the SHINE study with the goal of enrolling over 120 patients. Now, with regard to our trial, CT1812 is being tested in the ongoing SQL study of patients with mild to moderate AD. SQL is exploring the utility of quantitative EEG as a non-invasive biomarker of disease severity and treatment effect in patients given drug or placebo. We anticipate a data readout by year end. You may be aware that Cognition Therapeutics was given an $80 million grant to study patients with early AD. We anticipate initiating patient enrollment in a 540-patient Phase II trial in the second half of 22. This trial is being conducted in collaboration with the Alzheimer's Clinical Trial Consortium. One program I am particularly excited to tell you about is our trial in patients with DLB. We have evidence that the Sigma-2 receptor may be a promising target for DLB based on studies we've conducted which show an ability to block the toxic effect of alpha-synuclein oligomers. We recently initiated a Phase II trial of dementia with Lewy bodies to evaluate CT1812's potential as a disease-modifying therapy for these patients. and clinical sites are being onboarded now. This study is being conducted with our primary investigator, Dr. Jim Galvin at the University of Miami School of Medicine, and this study is funded by a $30 million grant award for the NIA. You may be aware that there are a very large number of people with DLB, 1.4 million people, and further, that there are no treatments for this condition. This further compels us to move forward expeditiously in our clinical trial. Finally, we plan to initiate a clinical program in the second half of 2022 to study the potential of CT1812 in patients with dry AMD. We have evidence from genome-wide studies as well as the analysis of results from our Alzheimer's trial that demonstrate treatment with CT1812 may have a beneficial impact on the proteins implicated in dry AMD. We look forward to presenting some of these findings during the Association for Research and Vision and Ophthalmology, better known as ARVO, at that meeting in May in Denver. Beyond CT1812, we're working to advance additional pipeline candidates for Parkinson's disease, and for this work, we have been recently awarded another grant from the Michael J. Fox Foundation. This is the second award from the Michael J. Fox Foundation for our research team. We look forward to sharing progress on both our preclinical and clinical programs throughout the year. Now, as I said at the beginning of the call, this is an exciting year at Cognition Therapeutics. I believe that we have the right expertise, scientific underpinnings, partnerships, non-dilutive grants, and capital to accelerate our mission of creating therapies for age-related neurodegenerative diseases. With that, I turn the call to Jim.