Cognition Therapeutics, Inc.

Good morning, ladies and gentlemen, and welcome to Cognition Therapeutics Second Quarter 2023 Earnings Conference Call. My name is Jenny, and I will be your conference operator today. This call is being recorded. I would like to turn the presentation over now to your host for today's call, Danielle Konzel-Boateng, Investor Relations for Cognition Therapeutics. Please proceed, Mr. Konzel-Boateng.

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 Therapeutics, and John Doyle, Chief Financial Officer of Cognition. A press release detailing Cognition Therapeutics second quarter 2023 results is available on the investor section of our website at CogRx.com. We encourage everyone to read this morning's press release as well as Cognition's quarterly report on Form 10-Q 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, 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 risk and uncertainties associated with the company's business. These forward-looking statements are qualified by the cautionary statements contained in Cognition's press release and SEC filings, including its quarterly report on Form 10-Q 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 now like to hand the call over to Lisa Ricciardi. Lisa?

Thank you, Daniel, and good morning, everyone. Welcome to Cognition Therapeutics Earnings Conference Call, covering the results for the second quarter of 2023. On today's call, our Chief Financial Officer, John Doyle, and I will share prepared remarks on the company's progress in financial performance in 2023, after which we'll be joined by Dr. Tony Caggiano, our chief medical officer and head of R&D for questions and answers. In the second quarter of 2023, we continued the progress and execution shown in the first quarter of the year. Our clinical leadership team continues to build what we believe will be a compelling evidence for the neuroprotective effects of orally delivered CT1812, our lead candidate. Our most recent evidence comes from the sequel trial results which we'll be covering in this call. As a reminder for investors, we have important data on multiple fronts. First, we've shown that CT1812 engages its target, the Sigma-2 receptor. Second, this engagement has physiologic consequences demonstrated by the results of anatomical endpoints in our SPARC trial. That is to say, flowing of brain volume atrophy. Third, we have preliminary cognitive data from the first cohort of patients in the SHINE study, and we have just added neurophysiology evidence demonstrating that CT1812 improved brain activity and connectivity compared to placebo as measured by quantitative EEG in our SQL study. As our research and clinical development operations team work diligently to progress CT1812, we are pleased to see the most positive, the recent positive events in the Alzheimer's field, including the full approval of Lecimbi. Lily and Asai have recently reported data supporting the role of amyloid in Alzheimer's disease. We continue to build evidence that supports targeting amyloid beta-oligomers. the toxic species driving neurodegeneration and Alzheimer's disease. Oligomers are an early stage product as the brain moves from monomers to A-beta plaques. We believe this is the optimal target in Alzheimer's disease. Mounting evidence demonstrates the neuroprotective mechanism of action of CT1812, which prevents the binding of oligomers to neurons by modulating the sigma-2 receptor. By doing so, CT1812 has the potential to prevent the loss of synapses and thus may slow or stop the progression of cognitive impairment. As other biologics join Lecimbi on the market, we believe that CT1812, an oral agent, may be complementary to these approaches. By acting on this novel mechanism, we do not anticipate incidents of ARIA, and we have not seen any to date in our studies. We also believe that administration of an oral drug will likely ease the burden of administration and access to therapy. Now, let me give you a brief update on our clinical trials. As previously mentioned, we reported top-line results from our exploratory SQL quantitative EEG study. The trial, Phase 2 trial, was conducted in the Netherlands with 16 people who have mild to moderate Alzheimer's disease. The top line data showed evidence that CT1812 had a direct impact on synapse function as measured by a positive change in the makeup or the composition of brain waves. Specifically, we saw proportionally fewer slow or theta waves, which are associated with cognitive impairment, and proportionally more alpha waves. These waves are considered the normal background activity. of a healthy, unimpaired brain. CT1812 also improved the connectivity between brain regions, which may allow for a more ready exchange of information between the regions. In the sequel trial, we observed changes in brain waves that are consistent with restoring wave patterns to that of healthy adults in just four weeks. For a chronic neurodegenerative disease like Alzheimer's disease, we are encouraged to see these changes in a short period of time and in a population of only 16 patients. In July, we announced that the 540 Phase II START trial for early Alzheimer's disease has activated the first clinical sites. Our trial is being conducted with our partner, the Alzheimer's Clinical Trial Consortium, or the ACTC. We expect 50 to 60 sites in North America to enroll patients with disease. These patients will be randomized to receive once daily CT1812 or placebo for 18 months. Also in July, we announced that our Magnify trial dosed the first participants. This trial is designed to study the efficacy of CT1812 in people with geographic atrophy, or GA, secondary to dry age-related macular degeneration. MAGNIFY is a randomized placebo-controlled trial that is expected to enroll 246 adults who have been diagnosed with dry AMD with measurable geographic atrophy. In the context of dry AMD, CT1812 as a once-daily oral drug has the potential to offer a non-invasive alternative to the approved treatment, which is administered as an intravitreal injection. In this study, CT1812 will be given for 24 months with an assessment to measure the slowing of disease progression as measured by changes in the geographic atrophy lesion size. Now, I would be remiss if I didn't highlight a major publication that our team authored along with collaborators. Published in the International Journal of Molecular Science, this peer-reviewed article titled Sigma-2 Receptors from Basic Biology to Therapeutic Target provides a comprehensive review of the biology and function of the Sigma-2 receptor and its potential as a therapeutic target for age-related neurodegenerative diseases, including Alzheimer's disease, dementia with Lewy bodies, and dry age-related macular degeneration. The work cited in this publication is exhaustive. You can find this and other publications on our website. Our research team continues to produce important scientific work building evidence of disease modification through proteomics studies. At the ADPD conference in Sweden, our team demonstrated the effects of CT1812 in altering Alzheimer's disease biology. An analysis of the impact of CT1812 on pathways implicated in dry AMD, age-related macular degeneration, was presented in April at the ARVO meeting. And just two weeks ago, we presented confirmatory pathway analyses in a mouse model of Alzheimer's disease at the AAIC meeting in Amsterdam. Said another way, we have shown consistent, measurable proteomic impact across our targets. Now, much of our work continues to be funded by thought-leading institutions, including the NIA, which has been a longtime supporter of our science from early preclinical work through the present. To date, we have received over $170 million in cumulative, non-dilutive grant awards from the NIA through a highly competitive, peer-reviewed application process, which we view as a validation of our scientific foundation. We are in a unique position among peers to have the majority of our clinical trials funded by non-dilutive capital. In summary, Cognition Therapeutics is progressing on all our target indications. We are driven to execute on aggressive milestones we have set for our trials. As our work continues through the second half of 2023 and 2024, I want to express our gratitude to the community of patients and caregivers to investigators who have shown such enthusiasm for our programs, as well as to our partners and collaborators, the NIA and other leading institutions, who have been generous in their support, as well as to our team. We look forward to continuing work together towards our goal of developing new treatment based on sound science to address these formidable diseases. With that, I turn the call to John Doyle. John?