Cognition Therapeutics (NASDAQ:CGTX) Q3 2026 Earnings Call

0:00 Good morning, ladies and gentlemen, and welcome to Cognition Therapeutics, Inc.'s third quarter 2026 earnings conference call. My name is Mark, and I will be your conference operator today. This call is being recorded. I would like to turn the presentation over to your host for today's call, Mike Moyer, Managing Director for Labsite Advisors. Please proceed, Mr. Moyer. Thank you, operator, and good morning, everyone. Welcome to Cognition Therapeutics' third quarter 2026 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 financial results for the quarter. We encourage everyone to read this morning's press release as well as Cognition's Form 10-Q, which is now filed with the SEC and available on our website.

0:52 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. 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 turn the call over to Lisa Ricciardi.

1:45 Lisa Ricciardi Mike, thank you, and good morning, everyone. As you can see on the agenda, first topic we'd like to cover on this call is the registrational plan for Zervimicine or CT1812 and the treatment of people with dementia with Lewy bodies, which we'll refer to in this call as DLB. Two weeks ago, we announced that we reached alignment with the FDA on a planned registrational trial for Zervimicine in people living with DLB. Investors who have been following Cognition are aware that this topic has been the subject of several meetings with the FDA. We conducted meetings in January, May, and October, and all along, we've encountered FDA staff at every step who are engaged and constructive.

2:36 And as a result of our interactions, Cognition Therapeutics is the first company to align on a phase three trial with the FDA for this class of drugs to treat DLB, to treat the condition of DLB. Other companies have designed phase three trials for symptomatic treatment, such as antipsychotics or medications for agitation in this population. Dervimicine is unique in that it is designed to slow the course of the disease, not just treat the symptoms. I am proud that we have tackled an unchartered development path together with the FDA. Now, we're working to complete a protocol for Zervimicine's Phase III program.

3:22 A complicating factor with DLV is a lack of biomarkers available to measure the progression of disease. Because of this, we and the FDA agreed on clinical endpoints that are aimed at showing changes in disease progressions. Now with that, let me introduce our Chief Medical Officer, Tony Caggiano, who can discuss these endpoints and the details of our trial. Tony? Thanks, Lisa. Cognition's founder, Dr. Susan Catalano, was strategically focused on small molecules that would protect neurons while efficiently crossing the blood-brain barrier. As a small molecule, Zervimicine has no need for a brain shuttle technology to access the CNS. It binds to the Sigma-2 receptor and protects neurons from toxic proteins.

4:09 It does not bind to or remove plaque, so we would not expect ARIA to be at risk with zirvimicine. And finally, we have an extensive patent estate on zirvimicine. The USPTO recently issued a patent on a new crystal formulation of zirvimicine, which provides protection through 2045. Here you can see the proposed study schematic for our phase three trial of zirvimicine in mild to moderate DLB. Participants will be randomized to receive either 100 milligrams of zirvimicine or placebo orally once a day for nine months. Many of the endpoints will look familiar to you as they were employed in the phase two shimmer study. The shimmer study met its primary goals of safety and tolerability.

4:56 Zirvimicine treatment in shimmer were shown to have a meaningful impact across the core features of DLB, including motor symptoms, fluctuations, cognition, and neuropsychiatric symptoms. In brief, everything was moving in the right direction. Neuropsychiatric symptoms in Shimmer were evaluated using the NPI-12, a tool that measures 12 behavioral symptoms, including psychosis, which is defined as hallucinations and delusions. Other behaviors including agitation, anxiety, and apathy are also reported in the NPI-12. When we focus on just the psychosis symptoms, progression was slowed by 89% with Xervimicine treatment.

5:43 Many of the symptoms we measured in Shimmer are core features required for diagnosis of DLB. The fact that Xervimicine treatment impacted all of these symptom domains confirms that it is not a symptomatic drug. By protecting neurons, we believe zirvimicine is slowing progression of the underlying disease, or it is a disease-modifying agent. The measurement of disease progression in DLB is challenging. Alzheimer's disease has imaging and blood tests designed to determine disease stage and treatment effects. None of these are available yet in DLB. During our meetings with the FDA, we discuss options for measuring changes in DLB disease progression. both FDA divisions of neurology and psychiatry agreed that changes in psychosis may serve as a proxy for changes in the underlying disease.

6:34 Today, clinicians rely on changes in key symptoms to monitor the patient's disease. However, not all symptoms are easily evaluated in DLB. For example, measuring cognition is complicated by the fluctuations that people with DLB experience. These fluctuations of attention and cognition can change from minute to minute and day to day. So a cognitive test taken Tuesday at 3pm, for example, may have a very different result from the same test taken Thursday at 10am. This makes it difficult to reliably test cognition in clinical trial participants. Interestingly, Psychosis affects up to 80% of people with DLB. It is often present in early stages before the other hallmark symptoms emerge, and it worsens in a predictable fashion as the disease progresses.

7:24 Psychosis is easily measurable and it may be a proxy for changes in overall disease progression. The FDA agreed with this assessment, and we are designing a phase three study with this in mind. The two endpoints we discussed with FDA are shown on this slide. Within the NPI-12, two of the 12 symptoms are hallucinations and delusions. This tool is called the NPI-2. It measures the frequency and severity of these two symptoms. The primary outcome measure in the phase three trial is the NPI-2. This assessment tool is well known to investigators and has been used extensively in clinical trials. When we discussed the shimmer data with the FDA, we identified that hallucinations and delusions, that the hallucination delusion results were some of the strongest from the study.

8:17 The NCI-2, which analyzed these data, has an excellent signal-to-noise ratio, suggesting it will be a powerful tool to detect treatment differences in our planned registrational trial. In addition, enrollment will be enriched with patients who have hallucinations and delusions at baseline. Together, these features give us confidence that the trial we have designed will be adequately powered and sufficiently controlled with a moderate sample size. In addition to the NPI-2, we are planning to include the ADCS-ADL, or Alzheimer's Disease Cooperative Study, activities of daily living scale as a key secondary endpoint. By using these two together, we will show how zirvimicine treatment impacts the progression of the disease.

9:02 Before we move on, I want to make an important distinction. Zervimicine is not an antipsychotic. Antipsychotics are effective at reducing acute symptoms of hallucinations and delusions. Antipsychotics are not, however, effective at slowing the course of the disease. As Zervimicine is the disease-modifying agent, we had approached the FDA to use a composite endpoint to assess the diverse symptomatology of DLV. in meeting with FDA became clear that there's no validated measure developed to assess its diverse symptomatology. FDA and Cognition agreed that cytosis could be used as an indicator of the overall disease progression. I'll turn the call back over to Lisa now, who can provide updates on the next steps for both DLB and Alzheimer's programs.

9:52 Thank you, Tony. Our immediate next step is finalization of a protocol, which will be submitted to the FDA for review. Consistent with our discussions with the FDA, our plan is to design a single pivotal study for vervimicine in DLB. We've had several conversations with the FDA, and they have agreed to consider a single pivotal trial. Their decision will be a matter of review upon receipt of our completed clinical trial data. Now, having just concluded our discussions with the FDA and having just received their minutes, we're now evaluating our options with investors, bankers, and strategics to secure sufficient study funding to conduct the study.

10:37 And in parallel, we're evaluating vendors for CRO partners as well as the look at initially clinical sites for the trial. Our goal remains to initiate this study in mid-2027. Now, in addition to our work on DLB, we're also approaching an important milestone in our START study. The START study, an ongoing trial, is a Phase II study in mild cognitive impairment and early Alzheimer's disease. This study has 545 patients in it. As a reminder, START is fully enrolled, fully funded with non-diluted capital from the NIA. The last participant in START was enrolled in November of 2025, and thus we're expecting top-line results in the second half of 27.

11:29 With that, John Doyle will review our financial results and provide a bit more color around our cash position. John? Thank you, Lisa. Cash, cash equivalents, and restricted cash equivalents as of September 30, 2026 were approximately $31.5 million. Total obligated grant funds remaining from the NIA were $18.2 million. R&D expenses were $5.1 million for the third quarter of 2026 compared to $3.8 million for the comparable period in 2025. The increase in research and development expenses was driven by higher trial activities with contract research organizations and professional fees. General administrative expenses were $2.3 million for the quarter compared to $2.6 million in 2025. The decrease in general administrative expenses was driven primarily by lower professional fees and compensation.

12:19 The company reported a net loss of $4.1 million, or $0.04 per basic and diluted share for the third quarter, compared to $4.9 million, or $0.06 per basic and diluted share for the same period in 2025. Based on our current spend, we estimate that we have sufficient cash to fund operations and capital expenditures into the fourth quarter of 2027. Lisa? Thank you, John. Operator, please open the call to questions. We will now begin the question and answer session. If you would like to ask a question, just press star followed by the number one on your telephone keypad. We'll pause for just a moment to compile the Q&A roster. And your first question comes from the line of William Wood with B.

13:06 Reilly Securities. William, please go ahead. Hi, thanks for taking our questions and congrats on the continued progress you've been making this quarter. So two from us if we can, you know, with your current funds sufficient into first quarter 2027, you know, could you provide or fourth quarter, sorry, could you provide any extra details on the cost of your DLB trial? Maybe you're thinking on advancing that forward, where the funds might come from, and then also in terms of With the START trial moving quickly towards your readout in the third quarter, could you provide any color on the baseline there, how it may compare to Phase 2 SHINES low-tau subpopulation analysis? Thank you.

13:56 Thanks for the question. Regarding the DLB study, we had been considering trials of about 750 participants when we initially planned the study, and this was targeting symptoms that included cognition and fluctuation. Trials of this size would have been about $150 million. Given our discussions recently with the FDA and clear focus on DLB and their agreement for us to use the NPI, We can conduct a well-powered registration trial with less than half this original number of participants. Regarding the STAR trial, we have not released or even analyzed the baseline data in order to compare it to the SHINE study. There will be a presentation at the CTAD meeting coming up in two weeks looking at how we recruited individuals in this study, which is slightly different than other studies had to the use of biomarkers and so forth, but based on data will not be presented yet.

15:07 Got it. Thank you very much. Again, if you'd like to ask a question, just press star followed by the number one on your telephone keypad. And your next question comes from the lineups of Ram Salvaraju with ACWainwright. Ram, please go ahead. Thanks so much for taking our questions and congratulations on all the recent progress, particularly on the FDA front. I was wondering if you could give us some additional qualitative color around the nature of hallucinations and delusions suffered typically by DLB patients. and how these worsen along with the kind of inevitable progression of the disease, as well as what you anticipate would be considered a clinically meaningful impact on that specific arena of DLB symptomatology.

16:02 Yes, thanks for those questions. So people with DLB have hallucinations and delusions, and the interesting thing is that Nearly 80% of individuals have hallucinations and delusions. Now, the type of hallucinations and delusions in this disease is a little different than other conditions. But in reality, that's not particularly important. They have certain types of hallucinations that in character are somewhat different than you might expect in schizophrenia or Alzheimer's disease. Now, the nice thing with the tool that we're using, the NPI, it's not restricted based on a particular type of hallucination or delusion.

16:48 It's general and allows it to be really crafted towards each and every participant. So indeed, people with DLP, their hallucinations and delusions worsen throughout the course of the disease. And the important thing that we did over the last year here is work with FDA to basically agree that whether you're looking at cognition or fluctuations or motor center, or in this case, the neuropsychiatric symptoms, they all could be a reasonable proxy for how the disease is progressing. And because we look at hallucinations and delusions over the last month, it's not subject to the issues of fluctuations that these other measures are. So it's a very good clinical tool to use.

17:36 So that's why we're using this as a general measure of Disease Progression. Rob, I can add that we have done a great deal of work with people who live with DLB. We don't refer to them as patients because we're not their doctors. And what you hear from these individuals is hallucinations of several natures. One of the things they talk a lot is about smell. I'm smelling burnt toast. That seemed to be a common thing, surprisingly. Other hallucinations are oral, A-U-R-A-L. Why is the American, the star-spangled banner playing all day long? There are visual hallucinations. I've heard repeatedly from physicians about people with DLB commenting on trains running through the backyard, children coming to the home for tea, things of this nature. Now, they're largely not bothered by these things.

18:31 but it does take them a while to come forward and talk about it. On the delusion side, I think it's pretty straightforward, what's most common, Capgras Syndrome. So you're looking across the table at your husband or your wife and you're going, you are not my husband or my wife, where is that person? You actually see correctly something is there but your brain interprets it as something else. So at a fundamental level, these are sort of definitional characterizations of hallucinations and delusions from patients as well as from the people who treat them. It's pretty consistent. And then just with respect to the risk-benefit profile that you expect to target with cervimicine, Lisa, you mentioned during your prepared remarks that, you know, atypical antipsychotics have historically been used, you know, in managing the symptoms of DLB patients. but of course that group of drugs is well known to have well documented chronic side effects that can be potentially very debilitating.

19:34 These are not side effects that are associated with Zervimicine or the class of drugs to which Zervimicine belongs. So would you deem that to be potentially a future meaningful clinical and competitive edge for Zervimicine were it to be approved in DLB? Oh, excellent question. The answer is very much yes. We've done a fair amount of research with prescribing doctors who treat this population, and they say pretty much what you said, Ron. They go, look, I know I have a lousy hand of cards here, if you will. There are drugs that have warning black box warnings. There are drugs that say there are fatalities in DLB patients. And so when they talk about how they treat these patients, they carefully weigh where they want to take the risk, but they're aware of it.

20:20 and so we believe that coming forward with a drug that can treat this population and has a safety profile that's been demonstrated in this population as well as what Tony indicated earlier, a very unlikely incidence of any ARIA at all, we feel that that will be an important differentiator. There really are not drugs for this patient population. You open the medicine chest and you find things from other conditions and you apply them to the symptoms and that's about as good as it gets. And the language I've articulated here is not different from the caregivers or the physicians. They think about it the same way. So I do think what you've expressed is a very important potential point of differentiation that we hope to demonstrate in our registrational trial.

21:11 Thank you. There's no further question at this time, and now I will turn the call back to Cognition's CEO for closing remarks. Mrs. Ricciardi, please go ahead. Thank you, Mark. Thank you. In closing, I want to reiterate how excited we are to be able to advance zirvimicine into a Phase III study. We plan to evaluate the potential to slow the progression of this disease. The work we undertook with the FDA's Office of Neuroscience concluded with a regulatory path for zirvimicine. But you know what? We believe we're paving the way for future innovations in this disease area. We want to thank the trial participants and their families as well as our advisors, clinical trial investigators, and our staff.

21:59 Thank you for joining us. I'll turn the call back to the operator to conclude our call.