Cognition Therapeutics (CGTX) Q4 2025 earnings call transcript

Thank you, Operator, and good morning, everyone. Welcome to COGNITION THERAPEUTICS fourth quarter and year-end 2025 results 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 2025 fourth quarter and year-end results. We encourage everyone to read this morning's press release, as well as Cognition's annual report on Form 10-K, which is now filed with the SEC 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 those 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, including its annual report on Form 10-K and previous filings. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast. Cognition undertakes an 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 turn the call over to CEO Lisa Burchardi.

Hi, thank you. Good morning, everyone. COGNITION's primary focus since its inception has been on the development of zervimicine for patients with debilitating neurodegenerative diseases. Zervimicine is the USAN name for CT1812. Over the past 18 months, we've reported data from two Phase II studies, one in dementia with Lewy body and a second one in mild to moderate Alzheimer's disease.

Finally, we concluded enrollment in our 18-month START trial. This is a 545-patient study in early Alzheimer's disease, and we've held meetings with both U. S. and European regulators. With data in hand and feedback from regulators, we've made the decision to prioritize development of zirvimicine for the treatment of DLB psychosis. I will turn the call over now to Tony Caggiano, our Chief Medical Officer, to walk you through the rationale.

Thank you. We recently published results from our Phase II Shimmer Study in DLB and showed that zirvimicine has a meaningful impact across DLB symptom domains, specifically movement, cognition, function, and behavior, including psychosis. These behavioral symptoms were the subject of our recent presentation at the Alzheimer's and Parkinson's disease conference last week in Copenhagen. These symptoms were measured in the Phase II trial using an assessment called the MPI-12, which is a 12-item index of neuropsychiatric symptoms. The zirvimicine showed a strong impact on the neuropsychiatric symptoms with an 86% slowing up progression relative to placebo. In the NPI-12 behavioral symptoms, the effects of zirvimicine were particularly notable for hallucinations and delusions, which collectively we refer to as psychosis.

This is an important finding on one of the topics that we discussed both with the FDA in our FDA Type C meeting in January as well as with our peers during the ADPD meeting. We are very encouraged by the response to this plan from our KOLs and expert consultants at ADPD. In our conversations with the FDA team, they agreed that the effects on psychosis were compelling and directed us to the Division of Psychiatry in order to define a path towards registration. The Division of Psychiatry has familiarity with trials designed to measure psychosis associated with neurologic disease. They have recently overseen registrational studies and new drug applications for Rxelty for Alzheimer's agitation and Nuplazib for Parkinson's disease psychosis.

We look forward to meeting with the Division of Psychiatry to discuss a registrational plan for the treatment of DLB psychosis. A meeting request for the Division has already been filed. Many of you who follow this space know that psychosis is commonly associated with neurodegenerative In DLB, psychosis is more prevalent than in other dementias and often occurs early in the course of the disease. As many as 80% of DLB patients experience psychosis. The presence of hallucinations is one of the core clinical criteria for diagnosis of DLB. Unlike psychiatric conditions like schizophrenia, some DLB patients recognize that these images, sensations, or sounds that they are experiencing are actually hallucinations. This is understandably very stressful, both to patients and to their families, and can lead to withdrawal from social activities and isolation negatively impacting the entire family unit.

Delusions are also common in DLB These are often imposter delusions where patients believe their friends and family members have been replaced by others pretending to be their family members These delusions are difficult to manage and can accelerate the family decision to move their loved ones into core care facilities As you can see, psychosis is extremely debilitating for DLV patients. There are no approved medications for DLV patients with psychosis.

Neurologists and psychiatrists have few treatment options for hallucinations and delusions, as most patients cannot tolerate traditional antipsychotics. Few clinical trials for patients with DLB psychosis have been conducted, and none have been successful to date. Most drugs in development for DLB psychosis are acute treatments, as they modulate specific receptors involved in psychosis. The difference between the acute treatment and cognitions approach is the mechanism.

Acute treatment acts rapidly to impact specific symptoms but does not change the course of the disease. Patient's disease continues to progress, their symptoms will worsen, and these acute treatments may become less effective over time.

Zerzimethine works differently by interrupting the basic pathophysiology of the disease. It has shown robust efficacy over six months in certain symptom domains of DLD, most notably behavioral symptoms including psychosis. In the Phase II Shimmer Study, patients with psychosis, anxiety, aggression, and aggression with zirvimethine were stable compared to these same symptoms that worsened in placebo-treated participants. As we mentioned, these data were presented last week at the ADPD meeting, and the posters are available on our website. Given the strength of psychosis data, we expect registrational studies focused on psychosis to be smaller and shorter than studies that focus on cognition and general symptomatology. Therefore, we believe that our decision to develop Zervimicine for DLB psychosis will allow us to expedite its path to market.

After completing our meeting with the Division of Psychiatry and receiving the official meeting minutes mid-year, we will issue an update in a press release.

Thank you, Tony. Before I move on, I'll add that one of the factors that led us to decide to pursue DLB psychosis was the anecdotal feedback from our Expanded Access Program, or as we refer to it, our EAP program. We started this program in mid-2025 after we received a philanthropic donation from a patient's family. The patient had been in our Phase II shimmer study. This family was driven to find a way to maintain access to zirvimacine because of the impact they believe it had on the patient with DLB. They were focused not only on their mental health needs, but that of the broader SHIMR trial population.

Once the EAP started, it quickly filled to capacity. The level of interest from DLB patients and their physicians was and is astounding. We still get queries from patients and families about gaining access or extending access to the drug. Now, since the EAP is open label, we're in a unique position to hear directly from patients and their loved ones. And the response has been consistent, that people believe the revimicine is making a tangible difference in their daily lives. These experiences fuel our desire to complete our development work. And if approved, see this drug available all over the world. Right now, we have funding to continue the EAP program for another 9 to 12 months.

Now, moving on to Alzheimer's disease. As you may recall, we completed the Phase 2 SHINE study in mild to moderate Alzheimer's disease in 2024. We saw a reduction in cognitive decline of 38%, and that is on the ATIS-COG-11 scale, in treated versus placebo patients. This was comparable to the effects observed in Phase III trials with the immunotherapeutics Kisunla and Likimbi.

In SHINE, the treatment effect was most pronounced in patients with lower levels of a protein called Ptau-217 in their blood. These participants experienced a 95% reduction in cognitive decline. When we met with the FDA during an end-of-phase 2 meeting in 2025, the FDA agreed with our proposal to screen for participants with lower levels of P-TAU-217. This strategy could expedite patient recruitment.

Importantly, it will also enrich the study with patients who are most likely to benefit from zervimicine treatment. Gerimicine currently is being studied in a Phase II trial called START in patients with mild cognitive impairment, or MCI, and early Alzheimer's disease. This study met its enrollment goal at the end of 2025 with a total of 545 participants. Top-line results are expected in 2027 after the last participants complete the 18-month treatment period. Given the strong results we observed with Zervimicine in the mild to moderate AD trial, we remain committed to developing Zervimicine for Alzheimer's disease, and we look forward to the results of our START trial.

With that, John Doyle will review our financial results and provide more color around our cash position and capital requirements. John?

Thank you, Lisa. Cash, cash equivalents, and restricted cash equivalents as of December 31, 2025 were approximately $37 million. And total grant funds remaining from the NIA were $35.7 million. We estimate that the company has sufficient cash to fund operations and capital expenditures through the second quarter of 2027. I will now turn the call over to the COGNITION Research and development expenses were million for the year ended December 31 2025 compared to million for 2024 The change in R expenses was driven by the completion of SHINE and SHIMR clinical trials and associated professional fees General and administrative expenses were million for the year ended December 31 2025 compared to million for 2024 This change in GNA expenses was driven primarily by reduced stock compensation expenses The company reported a net loss of $23.5 million, or $0.32 per basic and diluted share for the year ended December 31, 2025.

This is compared to a net loss of $34 million, or $0.86 per basic and diluted share for 2024. Lisa?

Thank you, John. I'll now turn the call back to our operator who can open this up to questions. Nikki?

Hi, good morning. Nice to talk to you. Right now, our priority is on developing zervimicine for DLB, and so we're not looking at an ophthalmology program at the moment. Thank you for the question. Great. Thank you.

Yeah. Yes, thank you for the question. As we mentioned, our intent is to develop this now for a label relating to psychosis in DLB, like we saw, as just mentioned, with Neuplazid and Ritzalte and Alzheimer's disease and Parkinson's disease, dementia. Now, you know, we have not completed, you know, the FDA meetings yet to comment on exactly what the outcome measure will be. We have to work on that, but you can imagine it will be very similar to what we've done here before. And certainly our intent is to move as expeditiously as possible through registrational trials. But again, until we have the meeting with FDA and have minutes, it would be premature to comment exactly what that would look like.

Yeah, you're correct. Those are the studies that we'd want to complete before starting those trials. Again, you know, based on the nature of these studies, these are very low-risk studies, right? They're really informing us on things such as, do we need to add any instructions as to whether people should take drug with or without food or have no instructions whatsoever? So these are extremely low risks that we just need to get behind us.

And as you mentioned, you're correct, we're moving from a capsule form to a tablet form, which we think will be better as this is eventually, right, hopefully once approved, commercialized. So those are all moving along, and we look to accomplish this all in this year, 2026.

Thanks for the question, Dental. We want to see the results of our START trial, big trial, important trial. We hope it builds on the SHINE results, which we've already seen, particularly those impressive effects in patients with low PTA.

With that kind of data, we can then prioritize in the out years, what do we do next? Right now on the fairway is the DLD study as a first priority. And then while that study is recruiting and getting underway, we anticipate seeing the results of START, which is the early AD trial. We find no means given up on AD. It's a question of prioritization. As a small company, we've chosen DLB Psychosis, and we'll get such great information sometime next year from START in AD.

So we haven't really announced exactly where the trial will be. Certainly, once we have agreement with FDA, as we've done with AD, we'll want to seek alignment with EMA before launching trials there. But it's a little premature to talk about exactly what those plans are.

Well, so we have a bit, right? So most of our studies are done on standard of care background medications. So obviously in Alzheimer's disease and our mild to moderate study, this was acetylcholine esterase inhibitors and memandine. And interestingly now, most people with DLB are also on acetylcholinesterase inhibitors. And in our trial, and this is all published information, about 80% or 85% of individuals were on acetylcholinesterase inhibitors. So the effects of our drug have been on top of these standard of care. Similarly, in our START trial in early AD, we've allowed people to be on and have been on, provided they are on a stable maintenance course of the immunotherapies, right, lakanumab and tenenumab.

And the intent there, as much as you suggested, to begin to collect data not only on zirbemisine alone, but is there any indication that there might be an additional benefit of using the drugs in combination. So that's the information that we have and will be getting in the near future.

What was the second part of your second question?

Got it.

Tony, do you want to take the first question? Sure. So, you know, we mentioned briefly, but obviously we didn't get into too much detail in our discussion. So you're right. So we don't believe that we are impacting the receptors, particularly, you know, known to be responsible for psychosis. What we believe, much like the global state of the disease, is that we're interrupting the basic pathophysiology by, just like in Alzheimer's disease, blocking the ability of A-beta oligomers to interact with neurons. We have similar data showing that we prevent the interaction of alpha-synuclein from interacting with their receptors, thereby preventing the basic damage to neurons. Now, the symptomatology in DLB from alpha-synuclein toxicity is based on where that toxicity is occurring.

And so, again, we believe that we are able to impact the broad symptomatology of the disease and that those effects, as we noted, were most notable or most measurable within the psychosis. So that's what we're pursuing.

Yeah, so we have not announced exactly what the study looks like and the duration. So, of course, that will certainly be a topic of our discussion with FDA. Obviously, you've seen the results of our SHIMR trial, and we won't want to stray too much from that design. And absolutely, we will have other measures, secondary measures, which, you know, are ranked and protected, looking at, you know, cognition and motor function and sleep and so forth. Again, because as you saw with the results of the SHIMR trial, you know, we were very impressed by the global impact of the drug on the disease. And certainly, eventually, we'll want to study those other impacts as well. The reason we're focusing right now on psychosis is because the impact of the drug on psychosis is really quite strong, and that gives us the ability to do smaller, faster trials and hopefully a much more efficient path to market.

All right, Nikki. We are looking forward to meeting with the FDA Psychiatry Division shortly. So, as Tony said, we can finalize our plans and timing for studying DLB psychosis. This is an important indication. It's currently unaddressed by any approved or unapproved medications. Based on our Phase II findings and anecdotal feedback, as we discussed in participants in our EAP program, we believe Zervinicine has the potential to be a first-in-class treatment option for DLB patients with psychosis.

With that, thank you all for joining us today.