Cognition Therapeutics 2026 Q3 Earnings Call

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. 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.

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 zervimesine, or CT1812, in 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 zervimesine 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.

As a result of our interactions, Cognition Therapeutics is the first company to align on a phase III trial with the FDA for this class of drugs to treat DLB, to treat the condition of DLB. Other companies have designed phase III trials for symptomatic treatment, such as antipsychotics or medications for agitation in this population. zervimesine 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 are working to complete a protocol for zervimesine's phase III program. A complicating factor with DLB is the 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 progression.

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, zervimesine 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. It does not bind to or remove plaque, so we would not expect ARIA to be at risk with zervimesine. Finally, we have an extensive patent estate on zervimesine. The USPTO recently issued a patent on a new crystal formulation of zervimesine, which provides protection through 2045. Here you can see the proposed study schematic for our phase III trial of zervimesine in mild to moderate DLB. Participants will be randomized to receive either 100 milligrams of zervimesine 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 II SHIMMER study. The SHIMMER study met its primary goals of safety and tolerability. zervimesine treatment in SHIMMER was 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 zervimesine treatment. Many of the symptoms we measured in SHIMMER are core features required for diagnosis of DLB.

The fact that zervimesine treatment impacted all of these symptom domains confirms that it is not a symptomatic drug. By protecting neurons, we believe zervimesine 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 discussed 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. Today, clinicians rely on changes in key symptoms to monitor their 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 3:00 P.M., for example, may have a very different result from the same test taken Thursday at 10:00 A.M. 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 hallmarks symptoms emerge, and it worsens in a predictable fashion as the disease progresses. Psychosis is easily measurable, it may be a proxy for changes in overall disease progression. The FDA agreed with this assessment, and we are designing a phase III 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 III 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. The NPI-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 zervimesine treatment impacts the progression of the disease. Before we move on, I want to make an important distinction. Zervimesine 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 zervimesine is a disease-modifying agent, we had approached the FDA to use a composite endpoint to assess the diverse symptomatology of DLB. In meeting with FDA, it became clear that there is no validated measure developed to assess its diverse symptomatology. FDA and Cognition agreed that psychosis could be used as an indicator of the overall disease progression.

I'll turn the call back over to Lisa now, who can provide an update on the next steps for both DLB and Alzheimer's programs.