NASDAQ:CGTX Cognition Therapeutics Q2 2024 Earnings Report $1.18 -0.03 (-2.07%) As of 01:10 PM Eastern This is a fair market value price provided by Massive. Learn more. ProfileEarnings HistoryForecast Cognition Therapeutics EPS ResultsActual EPS-$0.18Consensus EPS -$0.22Beat/MissBeat by +$0.04One Year Ago EPS-$0.16Cognition Therapeutics Revenue ResultsActual RevenueN/AExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/ACognition Therapeutics Announcement DetailsQuarterQ2 2024Date8/8/2024TimeBefore Market OpensConference Call DateThursday, August 8, 2024Conference Call Time8:30AM ETConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Cognition Therapeutics Q2 2024 Earnings Call TranscriptProvided by QuartrAugust 8, 2024 ShareLink copied to clipboard.Key Takeaways SHINE Phase 2 trial of CT1812 in mild to moderate Alzheimer’s disease showed a consistent 39% slowing in cognitive decline versus placebo at 6 months, with statistical significance observed at the mid‐point for pooled 100 mg arms. CT1812 demonstrated a favorable safety profile, with no ARIA‐E events, only mild/moderate adverse events, and no liver enzyme elevations at the 100 mg dose. Enrollment in the SHIMR Phase 2 trial for dementia with Lewy bodies is complete (130 participants), with top‐line data expected by year‐end to assess safety and cognitive outcomes. Ongoing START and MAGNIFY trials are actively recruiting to evaluate CT1812 in early Alzheimer’s patients on background anti‐amyloid antibodies and in geographic atrophy secondary to dry AMD, respectively. As of June 30, 2024, cash and equivalents of ~$28.5 million plus $57.3 million in NIA grant funds provide a runway into Q2 2025, indicating the need for additional funding to support later‐stage trials. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallCognition Therapeutics Q2 202400:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Operator00:00:00Thank you for standing by. At this time, we would like to welcome you to the Cognition Therapeutics Second Quarter 2024 Earnings Call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question-and-answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. I would now like to turn the conference over to Tom Johnson. Please go ahead. Tom JohnsonHead of Investor Relations at Cognition Therapeutics00:00:29Thank you, operator, and good morning, everyone. Welcome to the Cognition Therapeutics Second Quarter 2024 Results Conference Call. With me today are Lisa Ricciardi, President and Chief Executive Officer, John Doyle, Chief Financial Officer, and Tony Caggiano, Chief Medical Officer. This morning, the company issued a press release detailing its financial results for the second quarter and first half of the 2024 fiscal year. We encourage everyone to read this morning's press release, as well as Cognition's quarterly report on Form 10-Q, annual report on Form 10-K, and periodic reports on Form 8-K, which are 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. Tom JohnsonHead of Investor Relations at Cognition Therapeutics00:01:12Please note that certain information discussed on the call today is covered by 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 risks and uncertainties associated with the company's business. These forward-looking statements are qualified by cautionary statements contained in the Cognition press release and SEC filings, including its quarterly report on Form 10-Q and previous filings. This conference call contains time-sensitive information, which is accurate only 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 hand the call over to Lisa Ricciardi. Lisa? Lisa RicciardiCEO at Cognition Therapeutics00:02:03Thank you, Tom, and good morning, everyone. We appreciate your participation in Cognition Therapeutics Financial Results conference call. Today, our CFO, John Doyle, and I will share prepared remarks on the company's progress and financial performance over the first half of the year. After which, we'll take your questions. For Q&A, we'll be joined by our Chief Medical Officer and Head of R&D, Dr. Tony Caggiano. At Cognition Therapeutics, our focus is on the development of innovative, orally available drug candidates targeting age-related degenerative conditions of the CNS and retina. Our clinical programs include multiple Phase 2 trials for both early and mild to moderate Alzheimer's disease. We are also studying CT-1812 in dementia with Lewy bodies and geographic atrophy secondary to dry AMD. Lisa RicciardiCEO at Cognition Therapeutics00:03:01Now, during today's call, my formal remarks will be on the completed SHINE trial, and then on our next study to read out, the SHIMMER trial. Let's begin with SHINE. Our SHINE study was a phase II clinical trial, proof-of-concept study of CT-1812 in mild to moderate Alzheimer's disease. This was our first proof-of-concept study. The trial enrolled a total of 153 adults with mild to moderate Alzheimer's disease. Participants were randomized to receive either placebo or oral doses of 100 or 300 milligrams of CT-1812, and there were 51 participants in each arm of the study. Our primary purpose was to assess safety and tolerability after six months of daily dosing. We also evaluated multiple cognitive endpoints, including the ADAS-Cog 11, ADAS-Cog 13, cognitive composite, and the MMSE. Functional improvement scales were included, as were biomarker analyses. Lisa RicciardiCEO at Cognition Therapeutics00:04:10In this study, participants who were treated with CT-1812 for six months showed a consistent trend in slowing cognitive decline compared to placebo across all cognitive measures, the ADAS-Cog 11 and 13, cognitive composite, and MMSE. On the most commonly used measures, the ADAS-Cog 11 and 13 scales, CT-1812-treated participants showed a 39% slowing of cognitive decline after six months. To put SHINE results into context, the recently approved monoclonal antibodies demonstrated 25%-30% slowing in an early patient population over 18 months. We were very encouraged by the 39% slowing in six months with a once-daily pill. Now, furthermore, on the ADAS-Cog 11 and MMSE scales at day 98, the midpoint of the study, in the combined 100 and 300 mg dose group, p-values of less than 0.05 were observed. Lisa RicciardiCEO at Cognition Therapeutics00:05:25Putting the full SHINE data readouts in context, in the completed trial, participants on placebo in the intent-to-treat analysis worsened by 2.7 points as measured by ADAS-Cog 11. In the pooled 100 and 300 milligram dose group, there was a reduction of 1.66 points or a 39% slower loss of cognition than in the placebo group. Said another way, CT-1812 rescued about 40% of the cognitive decline that participants could have experienced.... In this trial, we used the functional measures of the ADCS-ADL, or Activities of Daily Living, and the ADCS-CGIC, the Clinical Global Impression of Change. CT-1812 demonstrated a slowing of loss of function towards the latter part of the trial. With 150 people enrolled, or approximately 50 people per arm, the SHINE trial did not achieve statistical significance on the ADAS-Cog 11 scale. Lisa RicciardiCEO at Cognition Therapeutics00:06:40However, this is the important part: the multiple measures we assessed show a consistency across time and dose that is positive. It is this consistency that motivates us to look ahead to longer and larger trials. With regard to safety, CT-1812 demonstrated a favorable safety and tolerability profile, with most treatment adverse events being mild or moderate. The AEs were consistent with previous clinical experience. There was one case of asymptomatic ARIA-H, and no cases of ARIA-E. At the 300 milligram dose, nine participants experienced treatment-emergent LFT increases greater than 3 times the upper limit of normal. These resolved after cessation of drug without evidence of serious liver injuries. Importantly, there were no LFT elevations observed in the 100 milligram dose. This data is all publicly available on our website. We are continuing to analyze the exploratory CSF biomarker program data. Lisa RicciardiCEO at Cognition Therapeutics00:07:59The study showed significant change in neurofilament light, or NfL, and this is a marker of neurodegenerative disease. This occurred at the 300 milligram dose. We believe that this is evidence CT-1812 acts as a synaptoprotective agent. Other CSF biomarkers assessed include neurogranin, synaptotagmin, SNAP-25, p-tau, total tau, and GFAP. We'll share more in the future as we continue analyzing biomarker data from this trial. Taken in total, we believe these findings provide evidence that the amyloid oligomer antagonism, a new and distinct mechanism for therapeutic intervention, may have a role as a monotherapy or a drug in treatment used in combination with approved drugs for the treatment of AD and other dementias. We met our key objectives of assessing safety, tolerability, and cognitive and functional changes. Lisa RicciardiCEO at Cognition Therapeutics00:09:10We learned that the 100 milligram dose showed good efficacy and had no incidence of elevated liver enzymes or discontinuations due to AEs. There were no new safety signals in the SHINE trial. We had a strong and consistent trend demonstrating potential efficacy at slowing cognitive decline in patients with mild to moderate disease. We believe the magnitude of effect is consistent with other drugs recently developed and approved. We believe the biomarker data supports the true slowing of neurodegeneration. While in Philadelphia last week at the AAIC conference, we had the opportunity to speak with multiple physicians and PIs from the SHINE trial. They were very supportive of the trial results, and particularly the consistency of cognitive changes across the scales. They valued the new safety information and profile of the 100 milligram dose group. Lisa RicciardiCEO at Cognition Therapeutics00:10:19Consistent with feedback from various investors, our PIs are interested in the next steps in terms of a new trial: duration, dose, patient population, endpoint, and trial size. We also know that pharma groups, having winnowed CNS programs over the years, are now looking to add to their portfolios important CNS drugs. For many, Alzheimer's disease is a top target. We are looking forward to continuing our dialogue with these companies. Our next step is to convene a panel of leading neurologists to review our data, assess the findings, and discuss their thinking on next steps in CT-1812 drug development. I would like now to turn to the SHIMMER study, which is our next data readout. This phase ii trial with CT-1812 enrolled 130 people with mild to moderate dementia with Lewy bodies, or DLB. Lisa RicciardiCEO at Cognition Therapeutics00:11:27As a reminder, there are an estimated 1.5 million people in the U.S. affected by DLB, and this disease is the second most common form of dementia. These patients are characterized by dementia, mobility issues, visual and sensory hallucinations, and significant GI issues. There are no currently approved treatment options. From a pathological perspective, more than half of the DLB patients are estimated to both have alpha-synuclein and A-beta oligomers in their brain. We believe that CT-1812, with its novel mechanism of action, protecting neurons from the pathogen, from the toxicity of both pathogenic proteins, has the potential to treat DLB patients. This is a double-blind, randomized, three-arm study. Patients are randomized 1:1:1, with 100 or 300 milligrams of CT-1812 or placebo. This study is not powered to show significance. Lisa RicciardiCEO at Cognition Therapeutics00:12:36It is designed as a proof-of-concept study to determine the change in the MoCA, if that is the Montreal Cognitive Assessment Scale, after six months of receiving CT-1812 or placebo. This trial is supported by non-dilutive funding from the NIH, and the trial is being led by Dr. James Galvin from the University of Miami Miller School of Medicine. We have completed enrollment, and we expect to report top-line results by year-end. We believe the SHIMMER trial results will add to the understanding of CT-1812's potential for treating neurodegenerative disease. As with AD patients in the SHINE trial, we look forward to providing patients and caregivers an effective, convenient option to slow the progress of DLB. Now, a word about our other two trials. In brief, our START, START trial is actively recruiting participants with early Alzheimer's disease. Lisa RicciardiCEO at Cognition Therapeutics00:13:44Participants on stable background therapy with lecanemab and donanemab will be allowed to enroll in the trial, and we expect this will allow us to provide real-world evidence of CT-1812's potential as monotherapy and in combination with monoclonal antibody treatments. We're also actively enrolling participants in our MAGNIFY study. This is a randomized, placebo-controlled, phase II study of 240 participants who have dry age-related macular degeneration and measurable geographic atrophy. Over the treatment period, change in lesion size and best-corrected visual acuity will be assessed to determine if CT-1812 can slow vision loss. Now, during this past year, Cognition scientists published multiple manuscripts and made at least nine presentations at medical and scientific conferences. All the publications are available on our website. Lisa RicciardiCEO at Cognition Therapeutics00:14:52Importantly, the scientific evidence generated by our team has continued to support our development efforts, providing insights into proteins and biological processes impacted by CT-1812 in neurological and dry AMD and ophthalmology conditions. In closing, in 2024, we have made significant progress advancing CT-1812, and we believe this drug has the potential to be an important part of the developing paradigm for dementia treatment. With that, I turn the call over to John Doyle for a review of our results. John DoyleCFO at Cognition Therapeutics00:15:32Thank you, Lisa. For the first half of 2024, we continued to execute with financial stewardship by efficiently managing our resources and leveraging NIA grant funding to support our clinical programs. As of June 30, 2024, our cash and cash equivalents were approximately $28.5 million, and total grant funds remaining from the NIA were $57.3 million. The company estimates that it has sufficient cash to fund operations and capital expenditures into the second quarter of 2025. Research and development expenses were $11.6 million for the second quarter and then June 30, 2024, compared to $8.5 million for the comparable period in 2023. This increase was primarily related to higher costs associated with advancing our clinical programs, including phase 2 trial activities with contract research organizations and personnel costs. John DoyleCFO at Cognition Therapeutics00:16:27General administrative expenses were $3.1 million for the second quarter and to June 30, 2024, compared to $3.3 million for the comparable period in 2023. The decrease was primarily related to lower professional services. The company recorded a net loss of $7 million, or $0.18 per basic and diluted share for the second quarter, and the June 30, 2024, compared to a net loss of $4.7 million, or $0.16 per basic and diluted share, for the same period in 2023. I'll now turn the call back over to the operator, who can open the call to questions. Operator? Operator00:17:06The floor is now open for your questions. So to ask a question this time, please press star one. We're going to pause for just a moment to compile the Q&A roster. First question comes from Charles Duncan from Cantor Fitzgerald. Elaine KimBiotech Equity Research Associate at Cantor Fitzgerald00:17:28Hi, this is Elaine Kim on for Charles Duncan. Thank you for taking our questions. So in the SHINE trial, the 100 mg dose did not meaningfully alter the A-beta 40 and 42 levels, while the 300 mg did. But would the changes with the 100 mg dose perhaps be more pronounced after a year of dosing versus the six months? And I have a follow-up. Lisa RicciardiCEO at Cognition Therapeutics00:17:56Tony, do you want to address that? Thank you, Elaine. Anthony CaggianoCMO at Cognition Therapeutics00:17:58Yeah. Yeah. Hi, Elaine. You're right, so the 100 milligram dose did not significantly alter the A-beta monomers in the same way that the 300 milligram dose had. I think a more relevant biomarker here is the NFL, which is a marker of general neurodegeneration, where we saw a really robust change both with the 300 and the 100. You know, the monomers, we believe, is part of the basic mechanism of our receptor rather than a key part of the disease-modifying process that you see here. To further answer your question around longer trials, we do expect that, you know, with longer trials, such as 12- or 18-month trials, we would then begin to see more of the downstream biomarkers moving as well. Elaine KimBiotech Equity Research Associate at Cantor Fitzgerald00:18:49Got it. Okay, that, that makes sense. Thank you. Anthony CaggianoCMO at Cognition Therapeutics00:18:51Yeah. Elaine KimBiotech Equity Research Associate at Cantor Fitzgerald00:18:52For the follow-up, your cash runway is into the second quarter of 2025. How do you plan on lengthening that runway and support later-stage trials, and I may be jumping the gun, but maybe up to phase three, how do you plan on doing that? John DoyleCFO at Cognition Therapeutics00:19:10Yeah. Thank you, Elaine. I mean, there's a lot of things that we need to evaluate. There's going to be a lot of options available to us. So as we look to extend our runway, we'll certainly take all of those into consideration and move forward as we design the next stage of those trials. Elaine KimBiotech Equity Research Associate at Cantor Fitzgerald00:19:25Got it. Thank you for taking our question. Operator00:19:31Our next question comes from Ram Selvaraju from H.C. Wainwright. Raghuram SelvarajuManaging Director and Senior Healthcare Equity Research Analyst at H.C. Wainwright00:19:39Thanks so much for taking my questions. First of all, somewhat intellectually provocative one, if I may. There was some discussion at AAIC in Philadelphia last month about the potential applicability of GLP-1 receptor agonism to the treatment of Alzheimer's disease. Do you think there could be any synergistic activity of CT-1812 with GLP-1 receptor agonists, specifically in the context of Alzheimer's? Lisa RicciardiCEO at Cognition Therapeutics00:20:05That's a very interesting question, Ram. Tony, any thoughts on that? Anthony CaggianoCMO at Cognition Therapeutics00:20:09Sure. Yeah, interesting. I think, obviously, the world is very interested to see how the GLP-1s behave in Alzheimer's disease. You know, given the mechanism of our drug is a, you know, very basic upstream interaction within the basic pathophysiology of Alzheimer's disease, we think CT-1812 has the potential as a monotherapy as well as in conjunction with other therapies. We're certainly interested in seeing it with approved, current approved therapies, and if GLP-1 were to be approved for Alzheimer's disease, it would be very interesting to see how it acts together. So perhaps in the future, we'll see that data. Raghuram SelvarajuManaging Director and Senior Healthcare Equity Research Analyst at H.C. Wainwright00:20:54Great. And then just a quick follow-up on the dosage. Anthony CaggianoCMO at Cognition Therapeutics00:20:57Yeah. Raghuram SelvarajuManaging Director and Senior Healthcare Equity Research Analyst at H.C. Wainwright00:20:57I was wondering if there were doses intermediate between the 100 and the 300 that you would consider assessing further in clinical development, or if at this juncture, you've ruled that out. If you were to study intermediate doses, which ones do you think are likely to be most appropriate? Anthony CaggianoCMO at Cognition Therapeutics00:21:19Yeah. So, we do have an intermediate dosage being studied right now. In our START trial, which is the 540 participant study in early Alzheimer's disease, we have a 200 milligram dose. And in our MAGNIFY trial, which is the study in dry AMD, we also have the 200 milligram dose. And indeed, we introduced those doses a few years back for this very reason, believing that it might be a very nice sweet spot, where we see really good efficacy, but fewer adverse events. So those doses are already in the clinic, and it's likely that we'll see them again in the future. Raghuram SelvarajuManaging Director and Senior Healthcare Equity Research Analyst at H.C. Wainwright00:22:01Thank you. Operator00:22:07Our next question comes from Mayank Mamtani from B. Riley. Kevin KuoEquity Research Analyst at B. Riley00:22:13Hi, can you hear me? Lisa RicciardiCEO at Cognition Therapeutics00:22:16Yes, Mayank, good morning. Kevin KuoEquity Research Analyst at B. Riley00:22:18Oh, this is Kevin Kuo, for Mayank. Thanks for taking our question. Lisa RicciardiCEO at Cognition Therapeutics00:22:23Oh, great. Kevin KuoEquity Research Analyst at B. Riley00:22:23So- Lisa RicciardiCEO at Cognition Therapeutics00:22:24Yeah. Hi, Kevin. Kevin KuoEquity Research Analyst at B. Riley00:22:26Hi. So now that we saw the data from the SHINE trial, just wondering if you can talk about your expectation for your SHIMMER trial later this year, and specifically, maybe your expectation for neurofilaments or other biomarkers that, such as GFAP, that may not be as relevant in different disease groups like Alzheimer's, but maybe have different actions in, like, DLB disease. And maybe if you can point to whether you would still expect 300 milligram to have some liver enzyme signal. Thanks. Lisa RicciardiCEO at Cognition Therapeutics00:23:14So I think there were three questions, Kevin. You broke up in the middle. One is overall expectations for SHIMMER. Second, you were looking for a read on a number of the biomarkers. And the last thing you mentioned was the 300 milligram dose. Kevin KuoEquity Research Analyst at B. Riley00:23:29Yes. Lisa RicciardiCEO at Cognition Therapeutics00:23:29You know, what might be the profile of that dose? I'll turn those three questions over to Tony. Anthony CaggianoCMO at Cognition Therapeutics00:23:34Sure. Yeah, thank you. Right, so the SHIMMER study is designed very much like the SHINE study was, enrolling similar number of individuals. You know, as a first proof of concept study, where we're really looking, again, for safety and tolerability, and then for a clear, you know, and consistent trend that we can slow progression of the disease across multiple outcome measures. As we've announced previously, we're looking for a readout, you know, towards the end of this year. As far as the biomarkers go, I think as you've implied, the biomarker profile and changes within DLB are not nearly as well studied or predictable as they are currently in Alzheimer's disease.... Anthony CaggianoCMO at Cognition Therapeutics00:24:19Having said that, we have a pretty robust program where we're looking at changes in biomarkers from both CSF and blood, looking at canonical biomarkers, as well as, as you've seen in our previous publications, proteomics and phosphoproteomics, looking at changes there. So we look forward to seeing those changes. As far as the liver signal goes, we would expect to see the same thing in these individuals. These are folks who are nearly the same age. There's no reason we would expect to see anything different. So obviously when that data reports out, we'll know that then. Operator00:25:02Okay, thanks. Our next question comes from Daniel Vitale from Chardan. Daniel VitaleEquity Research Analyst at Chardan00:25:15Hey, good morning, guys. Thank you for taking the question. Yeah, I have a couple. Lisa RicciardiCEO at Cognition Therapeutics00:25:19Morning, Daniel. Daniel VitaleEquity Research Analyst at Chardan00:25:21Yeah, good morning. Yeah, first, on the SHINE, you know, having had a bit of time to look through the data, and now thinking about the next steps, what do you think are the key learnings from SHINE that you look to incorporate into the next trial, you know, outside of it being a larger and a longer trial? Lisa RicciardiCEO at Cognition Therapeutics00:25:43Great question. Tony? Anthony CaggianoCMO at Cognition Therapeutics00:25:45Sure. Yeah, well, I think the key learnings, again, are that we saw a very, you know, consistent and clear trend across all the cognitive outcome measures, that we can slow disease progression. More specifically, you know, we see that the magnitude of effect here, as well as the variance. This study now allows us to power future studies. Again, having seen, you know, nearly 40% decrease in progression as per the ADAS-Cog scales, we can now look to the next round of studies, which I anticipate will both be quite larger and longer, so that we can see these changes. We've also nicely identified a dose range, right, where we see effect without troublesome adverse events. Anthony CaggianoCMO at Cognition Therapeutics00:26:34Indeed, as Lisa mentioned, there were no discontinuations due to AEs in the 100 milligram dose and no changes in liver enzymes. So we have a very nice place to operate here for future studies. Daniel VitaleEquity Research Analyst at Chardan00:26:50Excellent. Got it. And, another question, you know, with the recent approvals in Alzheimer's, how did that affect the enrollment rates for your CT-1812 trials? And, related to that, what fraction of participants in the START trial do you expect to be on concurrent approved Alzheimer's disease medications? Lisa RicciardiCEO at Cognition Therapeutics00:27:13Tony? Anthony CaggianoCMO at Cognition Therapeutics00:27:15Yeah. So, the inclusion criteria or the patient population for the monoclonal antibodies and for our SHINE participants were somewhat different. A little bit overlapping, but generally different. So I'm not sure it really impacted recruitment. I think overall, you know, having the general population now very aware and interested that there are drugs available for Alzheimer's disease has been a great asset, and people are coming, you know, into clinics and interested and inquiring. So overall, I'd say it was a boost. But again, it's a somewhat different population. As far as how many individuals will be randomized or will be on approved monoclonal antibodies within our START trial, that's still a little unknown. Anthony CaggianoCMO at Cognition Therapeutics00:28:07Obviously, one of the antibodies, you know, launched not long ago, and we'll see how it penetrates the market. The other antibody just recently received approval and is just now launching. Right, so we'll see. And within that study, we are stratifying all individuals so that we'll have an even number of people on monoclonal antibodies across the different treatment groups. So we'll have a very good look at, you know, safety and tolerability of combined, and depending on how many people we're able to to randomize, also potentially see if there are additive effects. Daniel VitaleEquity Research Analyst at Chardan00:28:44Okay. Got it. Thank you. Operator00:28:49There are no further questions at this time, so I'll turn the call back over to Lisa Ricciardi, CEO. Lisa RicciardiCEO at Cognition Therapeutics00:28:57All right, thank you. To conclude, we are focused on advancing our work to find a treatment to improve the lives of those afflicted with neurodegenerative diseases. The science is sound, we are compelled to move forward, and we continue to build evidence about what CT-1812 can do for patients. Thank you for joining us today. Operator00:29:24The meeting is now concluded. You may now disconnect.Read moreParticipantsExecutivesAnthony CaggianoCMOJohn DoyleCFOLisa RicciardiCEOTom JohnsonHead of Investor RelationsAnalystsDaniel VitaleEquity Research Analyst at ChardanElaine KimBiotech Equity Research Associate at Cantor FitzgeraldKevin KuoEquity Research Analyst at B. RileyRaghuram SelvarajuManaging Director and Senior Healthcare Equity Research Analyst at H.C. WainwrightPowered by Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Cognition Therapeutics Earnings HeadlinesAnalysts Offer Insights on Healthcare Companies: Rockwell Med (RMTI), 4D Molecular Therapeutics (FDMT) and Cognition Therapeutics (CGTX)May 11 at 7:32 AM | theglobeandmail.comCognition Therapeutics, Inc.: Cognition Therapeutics Reports Financial Results for the First Quarter 2026 and Provides Business UpdateMay 8 at 9:21 AM | finanznachrichten.deNobody Understands Why Trump Is Invading Iran (here’s the answer)Most investors are reacting to the Iran strikes without understanding the underlying motive driving the decision. Addison Wiggin, Founder of Grey Swan Investment Fraternity, says there is a hidden reason behind the bombing - and knowing it could change how you position your money right now.May 11 at 1:00 AM | Banyan Hill Publishing (Ad)Cognition Therapeutics Reports Financial Results for the First Quarter 2026 and Provides Business UpdateMay 7, 2026 | globenewswire.comCognition Therapeutics, Inc. CEO Lisa Ricciardi to Present at 25th Annual Needham Virtual Healthcare ConferenceApril 7, 2026 | quiverquant.comQCognition Therapeutics to Present at Needham Virtual Healthcare ConferenceApril 7, 2026 | globenewswire.comSee More Cognition Therapeutics Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Cognition Therapeutics? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Cognition Therapeutics and other key companies, straight to your email. Email Address About Cognition TherapeuticsCognition Therapeutics (NASDAQ:CGTX) is a clinical-stage biopharmaceutical company focused on developing disease-modifying therapies for neurodegenerative disorders, with an emphasis on Alzheimer’s disease. The company’s lead investigational candidate, CT1812, is an oral small molecule that antagonizes the sigma-2 receptor complex to protect synapses from amyloid-beta oligomer toxicity. By targeting a novel mechanism of action, Cognition Therapeutics aims to slow or reverse cognitive decline in patients living with Alzheimer’s disease. CT1812 has successfully completed Phase 1 safety studies and preliminary Phase 2a trials, and is currently being evaluated in multiple Phase 2 clinical studies across North America and Europe in patients with mild-to-moderate Alzheimer’s disease. In addition to its lead program, the company is advancing a preclinical pipeline aimed at expanding its approach to other neurodegenerative conditions. To support its global development efforts, Cognition Therapeutics collaborates with academic centers, contract research organizations and specialized clinical sites. Headquartered in Pittsburgh, Pennsylvania, Cognition Therapeutics conducts operations primarily in the United States, with ongoing clinical and regulatory activities in European markets. The company is led by co-founder and CEO Stephen M. Maccecchini, Ph.D., who oversees research, development and strategic partnerships. Cognition Therapeutics’ common stock is traded on the NASDAQ under the ticker symbol CGTX.View Cognition Therapeutics ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Latest Articles MercadoLibre Boldly Invests in Growth: Discount DeepensManic Monday.com: The Rally Is Just the Beginning for this SaaS LeaderMeta Platforms’ Wild Post-Earnings Swings: Where Analyst Price Targets Stand NowTapestry Stock Drops After Strong Quarter and Raised OutlookMarketBeat Week in Review – 05/04 - 05/08Quantum Earnings Season Is Ramping Up—What to Watch From 2 Major PlayersRocket Lab Posts Record Q1 Revenue, Raises Q2 Guidance Upcoming Earnings SEA (5/12/2026)Cisco Systems (5/13/2026)Alibaba Group (5/13/2026)Manulife Financial (5/13/2026)Sumitomo Mitsui Financial Group (5/13/2026)Takeda Pharmaceutical (5/13/2026)Applied Materials (5/14/2026)Brookfield (5/14/2026)National Grid Transco (5/14/2026)NU (5/14/2026) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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PresentationSkip to Participants Operator00:00:00Thank you for standing by. At this time, we would like to welcome you to the Cognition Therapeutics Second Quarter 2024 Earnings Call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question-and-answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. I would now like to turn the conference over to Tom Johnson. Please go ahead. Tom JohnsonHead of Investor Relations at Cognition Therapeutics00:00:29Thank you, operator, and good morning, everyone. Welcome to the Cognition Therapeutics Second Quarter 2024 Results Conference Call. With me today are Lisa Ricciardi, President and Chief Executive Officer, John Doyle, Chief Financial Officer, and Tony Caggiano, Chief Medical Officer. This morning, the company issued a press release detailing its financial results for the second quarter and first half of the 2024 fiscal year. We encourage everyone to read this morning's press release, as well as Cognition's quarterly report on Form 10-Q, annual report on Form 10-K, and periodic reports on Form 8-K, which are 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. Tom JohnsonHead of Investor Relations at Cognition Therapeutics00:01:12Please note that certain information discussed on the call today is covered by 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 risks and uncertainties associated with the company's business. These forward-looking statements are qualified by cautionary statements contained in the Cognition press release and SEC filings, including its quarterly report on Form 10-Q and previous filings. This conference call contains time-sensitive information, which is accurate only 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 hand the call over to Lisa Ricciardi. Lisa? Lisa RicciardiCEO at Cognition Therapeutics00:02:03Thank you, Tom, and good morning, everyone. We appreciate your participation in Cognition Therapeutics Financial Results conference call. Today, our CFO, John Doyle, and I will share prepared remarks on the company's progress and financial performance over the first half of the year. After which, we'll take your questions. For Q&A, we'll be joined by our Chief Medical Officer and Head of R&D, Dr. Tony Caggiano. At Cognition Therapeutics, our focus is on the development of innovative, orally available drug candidates targeting age-related degenerative conditions of the CNS and retina. Our clinical programs include multiple Phase 2 trials for both early and mild to moderate Alzheimer's disease. We are also studying CT-1812 in dementia with Lewy bodies and geographic atrophy secondary to dry AMD. Lisa RicciardiCEO at Cognition Therapeutics00:03:01Now, during today's call, my formal remarks will be on the completed SHINE trial, and then on our next study to read out, the SHIMMER trial. Let's begin with SHINE. Our SHINE study was a phase II clinical trial, proof-of-concept study of CT-1812 in mild to moderate Alzheimer's disease. This was our first proof-of-concept study. The trial enrolled a total of 153 adults with mild to moderate Alzheimer's disease. Participants were randomized to receive either placebo or oral doses of 100 or 300 milligrams of CT-1812, and there were 51 participants in each arm of the study. Our primary purpose was to assess safety and tolerability after six months of daily dosing. We also evaluated multiple cognitive endpoints, including the ADAS-Cog 11, ADAS-Cog 13, cognitive composite, and the MMSE. Functional improvement scales were included, as were biomarker analyses. Lisa RicciardiCEO at Cognition Therapeutics00:04:10In this study, participants who were treated with CT-1812 for six months showed a consistent trend in slowing cognitive decline compared to placebo across all cognitive measures, the ADAS-Cog 11 and 13, cognitive composite, and MMSE. On the most commonly used measures, the ADAS-Cog 11 and 13 scales, CT-1812-treated participants showed a 39% slowing of cognitive decline after six months. To put SHINE results into context, the recently approved monoclonal antibodies demonstrated 25%-30% slowing in an early patient population over 18 months. We were very encouraged by the 39% slowing in six months with a once-daily pill. Now, furthermore, on the ADAS-Cog 11 and MMSE scales at day 98, the midpoint of the study, in the combined 100 and 300 mg dose group, p-values of less than 0.05 were observed. Lisa RicciardiCEO at Cognition Therapeutics00:05:25Putting the full SHINE data readouts in context, in the completed trial, participants on placebo in the intent-to-treat analysis worsened by 2.7 points as measured by ADAS-Cog 11. In the pooled 100 and 300 milligram dose group, there was a reduction of 1.66 points or a 39% slower loss of cognition than in the placebo group. Said another way, CT-1812 rescued about 40% of the cognitive decline that participants could have experienced.... In this trial, we used the functional measures of the ADCS-ADL, or Activities of Daily Living, and the ADCS-CGIC, the Clinical Global Impression of Change. CT-1812 demonstrated a slowing of loss of function towards the latter part of the trial. With 150 people enrolled, or approximately 50 people per arm, the SHINE trial did not achieve statistical significance on the ADAS-Cog 11 scale. Lisa RicciardiCEO at Cognition Therapeutics00:06:40However, this is the important part: the multiple measures we assessed show a consistency across time and dose that is positive. It is this consistency that motivates us to look ahead to longer and larger trials. With regard to safety, CT-1812 demonstrated a favorable safety and tolerability profile, with most treatment adverse events being mild or moderate. The AEs were consistent with previous clinical experience. There was one case of asymptomatic ARIA-H, and no cases of ARIA-E. At the 300 milligram dose, nine participants experienced treatment-emergent LFT increases greater than 3 times the upper limit of normal. These resolved after cessation of drug without evidence of serious liver injuries. Importantly, there were no LFT elevations observed in the 100 milligram dose. This data is all publicly available on our website. We are continuing to analyze the exploratory CSF biomarker program data. Lisa RicciardiCEO at Cognition Therapeutics00:07:59The study showed significant change in neurofilament light, or NfL, and this is a marker of neurodegenerative disease. This occurred at the 300 milligram dose. We believe that this is evidence CT-1812 acts as a synaptoprotective agent. Other CSF biomarkers assessed include neurogranin, synaptotagmin, SNAP-25, p-tau, total tau, and GFAP. We'll share more in the future as we continue analyzing biomarker data from this trial. Taken in total, we believe these findings provide evidence that the amyloid oligomer antagonism, a new and distinct mechanism for therapeutic intervention, may have a role as a monotherapy or a drug in treatment used in combination with approved drugs for the treatment of AD and other dementias. We met our key objectives of assessing safety, tolerability, and cognitive and functional changes. Lisa RicciardiCEO at Cognition Therapeutics00:09:10We learned that the 100 milligram dose showed good efficacy and had no incidence of elevated liver enzymes or discontinuations due to AEs. There were no new safety signals in the SHINE trial. We had a strong and consistent trend demonstrating potential efficacy at slowing cognitive decline in patients with mild to moderate disease. We believe the magnitude of effect is consistent with other drugs recently developed and approved. We believe the biomarker data supports the true slowing of neurodegeneration. While in Philadelphia last week at the AAIC conference, we had the opportunity to speak with multiple physicians and PIs from the SHINE trial. They were very supportive of the trial results, and particularly the consistency of cognitive changes across the scales. They valued the new safety information and profile of the 100 milligram dose group. Lisa RicciardiCEO at Cognition Therapeutics00:10:19Consistent with feedback from various investors, our PIs are interested in the next steps in terms of a new trial: duration, dose, patient population, endpoint, and trial size. We also know that pharma groups, having winnowed CNS programs over the years, are now looking to add to their portfolios important CNS drugs. For many, Alzheimer's disease is a top target. We are looking forward to continuing our dialogue with these companies. Our next step is to convene a panel of leading neurologists to review our data, assess the findings, and discuss their thinking on next steps in CT-1812 drug development. I would like now to turn to the SHIMMER study, which is our next data readout. This phase ii trial with CT-1812 enrolled 130 people with mild to moderate dementia with Lewy bodies, or DLB. Lisa RicciardiCEO at Cognition Therapeutics00:11:27As a reminder, there are an estimated 1.5 million people in the U.S. affected by DLB, and this disease is the second most common form of dementia. These patients are characterized by dementia, mobility issues, visual and sensory hallucinations, and significant GI issues. There are no currently approved treatment options. From a pathological perspective, more than half of the DLB patients are estimated to both have alpha-synuclein and A-beta oligomers in their brain. We believe that CT-1812, with its novel mechanism of action, protecting neurons from the pathogen, from the toxicity of both pathogenic proteins, has the potential to treat DLB patients. This is a double-blind, randomized, three-arm study. Patients are randomized 1:1:1, with 100 or 300 milligrams of CT-1812 or placebo. This study is not powered to show significance. Lisa RicciardiCEO at Cognition Therapeutics00:12:36It is designed as a proof-of-concept study to determine the change in the MoCA, if that is the Montreal Cognitive Assessment Scale, after six months of receiving CT-1812 or placebo. This trial is supported by non-dilutive funding from the NIH, and the trial is being led by Dr. James Galvin from the University of Miami Miller School of Medicine. We have completed enrollment, and we expect to report top-line results by year-end. We believe the SHIMMER trial results will add to the understanding of CT-1812's potential for treating neurodegenerative disease. As with AD patients in the SHINE trial, we look forward to providing patients and caregivers an effective, convenient option to slow the progress of DLB. Now, a word about our other two trials. In brief, our START, START trial is actively recruiting participants with early Alzheimer's disease. Lisa RicciardiCEO at Cognition Therapeutics00:13:44Participants on stable background therapy with lecanemab and donanemab will be allowed to enroll in the trial, and we expect this will allow us to provide real-world evidence of CT-1812's potential as monotherapy and in combination with monoclonal antibody treatments. We're also actively enrolling participants in our MAGNIFY study. This is a randomized, placebo-controlled, phase II study of 240 participants who have dry age-related macular degeneration and measurable geographic atrophy. Over the treatment period, change in lesion size and best-corrected visual acuity will be assessed to determine if CT-1812 can slow vision loss. Now, during this past year, Cognition scientists published multiple manuscripts and made at least nine presentations at medical and scientific conferences. All the publications are available on our website. Lisa RicciardiCEO at Cognition Therapeutics00:14:52Importantly, the scientific evidence generated by our team has continued to support our development efforts, providing insights into proteins and biological processes impacted by CT-1812 in neurological and dry AMD and ophthalmology conditions. In closing, in 2024, we have made significant progress advancing CT-1812, and we believe this drug has the potential to be an important part of the developing paradigm for dementia treatment. With that, I turn the call over to John Doyle for a review of our results. John DoyleCFO at Cognition Therapeutics00:15:32Thank you, Lisa. For the first half of 2024, we continued to execute with financial stewardship by efficiently managing our resources and leveraging NIA grant funding to support our clinical programs. As of June 30, 2024, our cash and cash equivalents were approximately $28.5 million, and total grant funds remaining from the NIA were $57.3 million. The company estimates that it has sufficient cash to fund operations and capital expenditures into the second quarter of 2025. Research and development expenses were $11.6 million for the second quarter and then June 30, 2024, compared to $8.5 million for the comparable period in 2023. This increase was primarily related to higher costs associated with advancing our clinical programs, including phase 2 trial activities with contract research organizations and personnel costs. John DoyleCFO at Cognition Therapeutics00:16:27General administrative expenses were $3.1 million for the second quarter and to June 30, 2024, compared to $3.3 million for the comparable period in 2023. The decrease was primarily related to lower professional services. The company recorded a net loss of $7 million, or $0.18 per basic and diluted share for the second quarter, and the June 30, 2024, compared to a net loss of $4.7 million, or $0.16 per basic and diluted share, for the same period in 2023. I'll now turn the call back over to the operator, who can open the call to questions. Operator? Operator00:17:06The floor is now open for your questions. So to ask a question this time, please press star one. We're going to pause for just a moment to compile the Q&A roster. First question comes from Charles Duncan from Cantor Fitzgerald. Elaine KimBiotech Equity Research Associate at Cantor Fitzgerald00:17:28Hi, this is Elaine Kim on for Charles Duncan. Thank you for taking our questions. So in the SHINE trial, the 100 mg dose did not meaningfully alter the A-beta 40 and 42 levels, while the 300 mg did. But would the changes with the 100 mg dose perhaps be more pronounced after a year of dosing versus the six months? And I have a follow-up. Lisa RicciardiCEO at Cognition Therapeutics00:17:56Tony, do you want to address that? Thank you, Elaine. Anthony CaggianoCMO at Cognition Therapeutics00:17:58Yeah. Yeah. Hi, Elaine. You're right, so the 100 milligram dose did not significantly alter the A-beta monomers in the same way that the 300 milligram dose had. I think a more relevant biomarker here is the NFL, which is a marker of general neurodegeneration, where we saw a really robust change both with the 300 and the 100. You know, the monomers, we believe, is part of the basic mechanism of our receptor rather than a key part of the disease-modifying process that you see here. To further answer your question around longer trials, we do expect that, you know, with longer trials, such as 12- or 18-month trials, we would then begin to see more of the downstream biomarkers moving as well. Elaine KimBiotech Equity Research Associate at Cantor Fitzgerald00:18:49Got it. Okay, that, that makes sense. Thank you. Anthony CaggianoCMO at Cognition Therapeutics00:18:51Yeah. Elaine KimBiotech Equity Research Associate at Cantor Fitzgerald00:18:52For the follow-up, your cash runway is into the second quarter of 2025. How do you plan on lengthening that runway and support later-stage trials, and I may be jumping the gun, but maybe up to phase three, how do you plan on doing that? John DoyleCFO at Cognition Therapeutics00:19:10Yeah. Thank you, Elaine. I mean, there's a lot of things that we need to evaluate. There's going to be a lot of options available to us. So as we look to extend our runway, we'll certainly take all of those into consideration and move forward as we design the next stage of those trials. Elaine KimBiotech Equity Research Associate at Cantor Fitzgerald00:19:25Got it. Thank you for taking our question. Operator00:19:31Our next question comes from Ram Selvaraju from H.C. Wainwright. Raghuram SelvarajuManaging Director and Senior Healthcare Equity Research Analyst at H.C. Wainwright00:19:39Thanks so much for taking my questions. First of all, somewhat intellectually provocative one, if I may. There was some discussion at AAIC in Philadelphia last month about the potential applicability of GLP-1 receptor agonism to the treatment of Alzheimer's disease. Do you think there could be any synergistic activity of CT-1812 with GLP-1 receptor agonists, specifically in the context of Alzheimer's? Lisa RicciardiCEO at Cognition Therapeutics00:20:05That's a very interesting question, Ram. Tony, any thoughts on that? Anthony CaggianoCMO at Cognition Therapeutics00:20:09Sure. Yeah, interesting. I think, obviously, the world is very interested to see how the GLP-1s behave in Alzheimer's disease. You know, given the mechanism of our drug is a, you know, very basic upstream interaction within the basic pathophysiology of Alzheimer's disease, we think CT-1812 has the potential as a monotherapy as well as in conjunction with other therapies. We're certainly interested in seeing it with approved, current approved therapies, and if GLP-1 were to be approved for Alzheimer's disease, it would be very interesting to see how it acts together. So perhaps in the future, we'll see that data. Raghuram SelvarajuManaging Director and Senior Healthcare Equity Research Analyst at H.C. Wainwright00:20:54Great. And then just a quick follow-up on the dosage. Anthony CaggianoCMO at Cognition Therapeutics00:20:57Yeah. Raghuram SelvarajuManaging Director and Senior Healthcare Equity Research Analyst at H.C. Wainwright00:20:57I was wondering if there were doses intermediate between the 100 and the 300 that you would consider assessing further in clinical development, or if at this juncture, you've ruled that out. If you were to study intermediate doses, which ones do you think are likely to be most appropriate? Anthony CaggianoCMO at Cognition Therapeutics00:21:19Yeah. So, we do have an intermediate dosage being studied right now. In our START trial, which is the 540 participant study in early Alzheimer's disease, we have a 200 milligram dose. And in our MAGNIFY trial, which is the study in dry AMD, we also have the 200 milligram dose. And indeed, we introduced those doses a few years back for this very reason, believing that it might be a very nice sweet spot, where we see really good efficacy, but fewer adverse events. So those doses are already in the clinic, and it's likely that we'll see them again in the future. Raghuram SelvarajuManaging Director and Senior Healthcare Equity Research Analyst at H.C. Wainwright00:22:01Thank you. Operator00:22:07Our next question comes from Mayank Mamtani from B. Riley. Kevin KuoEquity Research Analyst at B. Riley00:22:13Hi, can you hear me? Lisa RicciardiCEO at Cognition Therapeutics00:22:16Yes, Mayank, good morning. Kevin KuoEquity Research Analyst at B. Riley00:22:18Oh, this is Kevin Kuo, for Mayank. Thanks for taking our question. Lisa RicciardiCEO at Cognition Therapeutics00:22:23Oh, great. Kevin KuoEquity Research Analyst at B. Riley00:22:23So- Lisa RicciardiCEO at Cognition Therapeutics00:22:24Yeah. Hi, Kevin. Kevin KuoEquity Research Analyst at B. Riley00:22:26Hi. So now that we saw the data from the SHINE trial, just wondering if you can talk about your expectation for your SHIMMER trial later this year, and specifically, maybe your expectation for neurofilaments or other biomarkers that, such as GFAP, that may not be as relevant in different disease groups like Alzheimer's, but maybe have different actions in, like, DLB disease. And maybe if you can point to whether you would still expect 300 milligram to have some liver enzyme signal. Thanks. Lisa RicciardiCEO at Cognition Therapeutics00:23:14So I think there were three questions, Kevin. You broke up in the middle. One is overall expectations for SHIMMER. Second, you were looking for a read on a number of the biomarkers. And the last thing you mentioned was the 300 milligram dose. Kevin KuoEquity Research Analyst at B. Riley00:23:29Yes. Lisa RicciardiCEO at Cognition Therapeutics00:23:29You know, what might be the profile of that dose? I'll turn those three questions over to Tony. Anthony CaggianoCMO at Cognition Therapeutics00:23:34Sure. Yeah, thank you. Right, so the SHIMMER study is designed very much like the SHINE study was, enrolling similar number of individuals. You know, as a first proof of concept study, where we're really looking, again, for safety and tolerability, and then for a clear, you know, and consistent trend that we can slow progression of the disease across multiple outcome measures. As we've announced previously, we're looking for a readout, you know, towards the end of this year. As far as the biomarkers go, I think as you've implied, the biomarker profile and changes within DLB are not nearly as well studied or predictable as they are currently in Alzheimer's disease.... Anthony CaggianoCMO at Cognition Therapeutics00:24:19Having said that, we have a pretty robust program where we're looking at changes in biomarkers from both CSF and blood, looking at canonical biomarkers, as well as, as you've seen in our previous publications, proteomics and phosphoproteomics, looking at changes there. So we look forward to seeing those changes. As far as the liver signal goes, we would expect to see the same thing in these individuals. These are folks who are nearly the same age. There's no reason we would expect to see anything different. So obviously when that data reports out, we'll know that then. Operator00:25:02Okay, thanks. Our next question comes from Daniel Vitale from Chardan. Daniel VitaleEquity Research Analyst at Chardan00:25:15Hey, good morning, guys. Thank you for taking the question. Yeah, I have a couple. Lisa RicciardiCEO at Cognition Therapeutics00:25:19Morning, Daniel. Daniel VitaleEquity Research Analyst at Chardan00:25:21Yeah, good morning. Yeah, first, on the SHINE, you know, having had a bit of time to look through the data, and now thinking about the next steps, what do you think are the key learnings from SHINE that you look to incorporate into the next trial, you know, outside of it being a larger and a longer trial? Lisa RicciardiCEO at Cognition Therapeutics00:25:43Great question. Tony? Anthony CaggianoCMO at Cognition Therapeutics00:25:45Sure. Yeah, well, I think the key learnings, again, are that we saw a very, you know, consistent and clear trend across all the cognitive outcome measures, that we can slow disease progression. More specifically, you know, we see that the magnitude of effect here, as well as the variance. This study now allows us to power future studies. Again, having seen, you know, nearly 40% decrease in progression as per the ADAS-Cog scales, we can now look to the next round of studies, which I anticipate will both be quite larger and longer, so that we can see these changes. We've also nicely identified a dose range, right, where we see effect without troublesome adverse events. Anthony CaggianoCMO at Cognition Therapeutics00:26:34Indeed, as Lisa mentioned, there were no discontinuations due to AEs in the 100 milligram dose and no changes in liver enzymes. So we have a very nice place to operate here for future studies. Daniel VitaleEquity Research Analyst at Chardan00:26:50Excellent. Got it. And, another question, you know, with the recent approvals in Alzheimer's, how did that affect the enrollment rates for your CT-1812 trials? And, related to that, what fraction of participants in the START trial do you expect to be on concurrent approved Alzheimer's disease medications? Lisa RicciardiCEO at Cognition Therapeutics00:27:13Tony? Anthony CaggianoCMO at Cognition Therapeutics00:27:15Yeah. So, the inclusion criteria or the patient population for the monoclonal antibodies and for our SHINE participants were somewhat different. A little bit overlapping, but generally different. So I'm not sure it really impacted recruitment. I think overall, you know, having the general population now very aware and interested that there are drugs available for Alzheimer's disease has been a great asset, and people are coming, you know, into clinics and interested and inquiring. So overall, I'd say it was a boost. But again, it's a somewhat different population. As far as how many individuals will be randomized or will be on approved monoclonal antibodies within our START trial, that's still a little unknown. Anthony CaggianoCMO at Cognition Therapeutics00:28:07Obviously, one of the antibodies, you know, launched not long ago, and we'll see how it penetrates the market. The other antibody just recently received approval and is just now launching. Right, so we'll see. And within that study, we are stratifying all individuals so that we'll have an even number of people on monoclonal antibodies across the different treatment groups. So we'll have a very good look at, you know, safety and tolerability of combined, and depending on how many people we're able to to randomize, also potentially see if there are additive effects. Daniel VitaleEquity Research Analyst at Chardan00:28:44Okay. Got it. Thank you. Operator00:28:49There are no further questions at this time, so I'll turn the call back over to Lisa Ricciardi, CEO. Lisa RicciardiCEO at Cognition Therapeutics00:28:57All right, thank you. To conclude, we are focused on advancing our work to find a treatment to improve the lives of those afflicted with neurodegenerative diseases. The science is sound, we are compelled to move forward, and we continue to build evidence about what CT-1812 can do for patients. Thank you for joining us today. Operator00:29:24The meeting is now concluded. You may now disconnect.Read moreParticipantsExecutivesAnthony CaggianoCMOJohn DoyleCFOLisa RicciardiCEOTom JohnsonHead of Investor RelationsAnalystsDaniel VitaleEquity Research Analyst at ChardanElaine KimBiotech Equity Research Associate at Cantor FitzgeraldKevin KuoEquity Research Analyst at B. RileyRaghuram SelvarajuManaging Director and Senior Healthcare Equity Research Analyst at H.C. WainwrightPowered by