Cognition Therapeutics (CGTX) Q3 2026 Earnings Call: DLB-Phase-III-Plan schreitet voran

Wichtigste Erkenntnisse

• Cognition Therapeutics gab bekannt, dass sich das Unternehmen mit der FDA auf das geplante Design der zulassungsrelevanten Phase-III-Studie für Zervimesin (CT1812) bei leichter bis mittelschwerer Lewy-Körperchen-Demenz (DLB) verständigt hat.
• Die geplante Studie soll die einmal tägliche orale Verabreichung von 100 mg Zervimesin über einen Zeitraum von neun Monaten mit Placebo vergleichen. Vorbehaltlich der Fertigstellung des Studienprotokolls und einer ausreichenden Finanzierung strebt die Unternehmensführung einen Beginn der Studie für Mitte 2027 an.
• Nach Gesprächen mit der FDA geht das Unternehmen davon aus, dass für die Zulassungsstudie weniger als die Hälfte der ursprünglich vorgesehenen rund 750 Teilnehmer erforderlich sein wird. Für dieses ursprüngliche Design waren Kosten von etwa 150 Millionen US-Dollar veranschlagt worden.
• Die flüssigen Mittel sowie die Barmittel mit Verfügungsbeschränkung beliefen sich zum 30. September 2026 auf insgesamt rund 31,5 Millionen US-Dollar. Das Management geht davon aus, dass die aktuellen Ressourcen den Geschäftsbetrieb und die Investitionsausgaben bis in das vierte Quartal 2027 finanzieren werden.
• Der Nettoverlust im dritten Quartal verringerte sich von 4,9 Millionen US-Dollar bzw. 0,06 US-Dollar je Aktie im Vorjahreszeitraum auf 4,1 Millionen US-Dollar bzw. 0,04 US-Dollar je unverwässerter und verwässerter Aktie.
• Die Phase-II-Studie START mit 545 Teilnehmern bei leichter kognitiver Beeinträchtigung und früher Alzheimer-Krankheit ist vollständig rekrutiert und wird mit nicht verwässerndem Kapital des National Institute on Aging finanziert. Das Management erwartet erste Top-Line-Ergebnisse in der zweiten Jahreshälfte 2027.

Wichtige Finanzkennzahlen

Geschäftliche und operative Entwicklung

Zervimesin ist ein niedermolekularer Wirkstoff, der die Blut-Hirn-Schranke überwinden und an den Sigma-2-Rezeptor binden soll, um Neuronen vor toxischen Proteinen zu schützen. Das Management betonte, dass der Wirkstoff weder an Plaques bindet noch diese abbaut und daher voraussichtlich kein Risiko für Amyloid-assoziierte Bildgebungsanomalien (ARIA) birgt.

In die vorgeschlagene Phase-III-DLB-Studie sollen Patienten mit leichter bis mittelschwerer Erkrankung aufgenommen werden, wobei die Rekrutierung gezielt auf Personen mit Halluzinationen und Wahnvorstellungen zu Studienbeginn ausgerichtet wird. Der primäre Endpunkt wird sich auf die Komponenten für Halluzinationen und Wahnvorstellungen des NPI-12 konzentrieren. Als wichtiger sekundärer Endpunkt ist die ADCS-ADL-Skala für Aktivitäten des täglichen Lebens vorgesehen.

Das Design baut auf der Phase-II-Studie SHIMMER auf, die ihren primären Endpunkt bezüglich Sicherheit und Verträglichkeit erreicht hat. Dem Management zufolge erzielte Zervimesin vorteilhafte richtungsweisende Ergebnisse bei motorischen Symptomen, kognitiven Schwankungen und neuropsychiatrischen Symptomen. Das Fortschreiten der Psychosesymptome wurde in SHIMMER laut Angaben des Unternehmens um 89 % verlangsamt.

Cognition Therapeutics konzipiert das Programm als einzelne Zulassungsstudie. Die FDA hat sich bereit erklärt, diesen Ansatz in Betracht zu ziehen; jede Entscheidung bleibt jedoch von der Prüfung der Daten nach Abschluss der klinischen Studie abhängig.

Das Unternehmen treibt zudem die Phase-II-Studie START mit 545 Teilnehmern mit leichter kognitiver Beeinträchtigung und früher Alzheimer-Krankheit voran. Die Studie ist vollständig rekrutiert und wird durch Fördermittel des NIA unterstützt. Der letzte Teilnehmer wurde im November 2025 aufgenommen.

Das Management wies zudem darauf hin, dass ein kürzlich erteiltes US-Patent für eine neue Kristallformulierung von Zervimesin Schutz bis 2045 bietet.

Ausblick des Managements

Das Management beabsichtigt, das Protokoll für die Phase-III-DLB-Studie abzuschließen und bei der FDA zur Prüfung einzureichen. Parallel dazu evaluiert das Unternehmen Auftragsforschungsinstitute, erste Prüfzentren sowie Finanzierungsoptionen unter Einbeziehung von Investoren, Banken und potenziellen strategischen Partnern.

Ziel des Unternehmens ist es, die Phase-III-DLB-Studie Mitte 2027 zu beginnen. Ausgehend von den aktuellen Ausgaben schätzt das Management, dass die verfügbaren Barmittel den operativen Geschäftsbetrieb und die Investitionen bis in das vierte Quartal 2027 decken werden.

Top-Line-Ergebnisse der Alzheimer-Studie START werden dem Management zufolge in der zweiten Jahreshälfte 2027 erwartet.

Risiken und wichtige Beobachtungspunkte

• Die geplante Phase-III-DLB-Studie erfordert zusätzliche Mittel, und das Unternehmen prüft weiterhin Finanzierungs- und strategische Optionen.
• Obwohl die FDA eine einzelne Zulassungsstudie in Erwägung ziehen wird, bleibt die Akzeptanz dieses Weges von der Auswertung der abgeschlossenen Studiendaten abhängig.
• Bei DLB mangelt es an etablierten Bildgebungs- und Blut-Biomarkern zur Bestimmung des Krankheitsstadiums und von Therapieeffekten. Das Phase-III-Design nutzt daher Veränderungen der Psychose als Surrogatparameter für das Fortschreiten der zugrunde liegenden Erkrankung.
• Kognitive Tests bei DLB können durch kurzfristige und tägliche Schwankungen bei Aufmerksamkeit und Kognition erschwert werden.
• Der Beginn der Studie hängt weiterhin von der Fertigstellung des Studienprotokolls, der FDA-Prüfung, der Auswahl von Dienstleistern, der Vorbereitung der Prüfzentren und der Finanzierung ab.

Höhepunkte der Fragerunde für Analysten

Dem Management zufolge sah das frühere Konzept für die DLB-Studie rund 750 Teilnehmer vor und hätte etwa 150 Millionen US-Dollar gekostet. Nach Gesprächen mit der FDA und einer gezielteren Ausrichtung auf die Psychosesymptomatik geht das Unternehmen davon aus, dass eine statistisch ausreichend aussagekräftige Zulassungsstudie mit weniger als der Hälfte dieser Teilnehmerzahl durchgeführt werden kann.

Hinsichtlich der START-Studie erklärte das Management, dass es bislang weder Ausgangsdaten veröffentlicht noch für einen Vergleich mit der früheren SHINE-Studie analysiert habe. Das Unternehmen plant, die Rekrutierungsmethoden, einschließlich des Einsatzes von Biomarkern, auf einer bevorstehenden CTAD-Konferenz zu erörtern.

Zur klinischen Relevanz von Psychosen erklärte das Management, dass Halluzinationen und Wahnvorstellungen fast 80 % der Menschen mit DLB betreffen und sich mit fortschreitender Erkrankung im Allgemeinen verschlimmern. Das gewählte Erhebungsinstrument sei nicht auf eine bestimmte Art von Halluzinationen oder Wahnvorstellungen beschränkt und lasse sich bei allen Teilnehmern anwenden.

Zudem hob das Management das Sicherheitsprofil als potenzielles Unterscheidungsmerkmal gegenüber Antipsychotika hervor, die derzeit zur Behandlung von DLB-Symptomen eingesetzt werden. Das Unternehmen betonte, dass Zervimesin kein Antipsychotikum sei und darauf abziele, das Fortschreiten der zugrunde liegenden Erkrankung zu verlangsamen, anstatt lediglich akute Symptome zu lindern.

Vollständiges Transkript der Telefonkonferenz zu den Ergebnissen

Vollständiges Transkript der Telefonkonferenz

Ausführungen des Managements

Operator

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 Mauger, Financing Director for LifeSciAdvisors. proceed, Mr. Moyer.

Mike 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 cognitions 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 movie 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 cognitions 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.

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 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 zervimesine and 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. And 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 treatments 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're working to complete a protocol for zervimesine 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. And with that, let me introduce our Chief Medical Officer, Tony Caggiano, who can discuss these endpoints and the details of our trial. Tony?

Anthony Caggiano

Thanks, Lisa. Cognition's Founder, Dr. Susan Catalano, was strategically focused on small molecules that would protect neurons while efficiently crossing blood-brain barrier. As a small molecule, zervimesine has no need for 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.

And finally, we have an extensive patent estate on zervimesine. The U.S. CTO 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 9 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 goal 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 of 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 systems, progression was slowed by 89% with zervimesine treatment. Many of the symptoms we measured at 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 asymptomatic 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 DLB is challenging.

Alzheimer's disease has imaging and blood test 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 the patient's disease. However, not all symptoms are easily evaluated in DLB. For example, measuring cognition is complicated by the fluctuations that people and DLB experience. These fluctuations of attention and cognition can change for a minute to minute and day-to-day. So a cognitive test taken Tuesday at 3 p.m., for example, may have a very different result from the same test taken Thursday at 10 a.m. This makes it difficult to reliably test cognition and 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. Psychosis is easily measurable and maybe a proxy for changes in overall disease progression. The FDA agreed with its assessment, and we are designing a Phase III study with this in mind. The 2 end points we discussed with FDA are shown on this slide. Within the NPI-12, 2 of the 12 symptoms are hallucinations and delusions. This tool is called the NCI in measures the frequency and severity of 2 symptoms. The primary outcome measure in the Phase III trial is the NPI. This assessment tool is well known to investigators and has been used extensively in clinical trials. When we discussed the summer data with the FDA, we identified that hallucinations and delusions, the lutein dilution results were some of the strongest from the study. The NPI which analyze these data has some excellent signal-to-noise ratio, suggesting it will be a powerful tool 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 NKI2, we are planning to include the ADCS-ADL for Alzheimer's Disease Cooperative study activities of daily living scale as a key secondary endpoint. By using these 2 together, we will show how zervimesine treatment impact the progression of the disease. Before we move on, I want to make an important distinction. -- even machine is not an antipsychotic. Antipsychotics are effective on reducing acute symptoms of those inflammation or delusions. Antipsychotics are not, however, effective as slowing in the course of the disease. As they're anything as the disease-modifying agents, 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 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 program.

Lisa Ricciardi

Thank you, Tony. Our immediate next step is finalization of the 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 zervemecine 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. Having just concluded our discussions with the FDA and having just received their minutes, we're now evaluating our options with investors, bankers and strategic to secure sufficient study funding to conduct the study.

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 nondilutive capital from the NIA. The last participant in start was enrolled in November of 2025. thus, we're expecting top line results in the second half of 2017. With that, John Doyle will review our financial results and provide a bit more color around our cash position. John?

John Doyle

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 '26 compared to $3.8 million for the comparable period in '25. The increase in research and development expenses was driven by higher trial activities with contract research organizations and professional fees. General and 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.

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?

Lisa Ricciardi

Thank you, John. Operator, please open the call to questions.

Operator

[Operator Instructions]

And your first question comes from the line of William Wood with B. Riley Securities.

Fragen und Antworten

William Wood

So 2 for us if we can with your current funds submission into first quarter 2027, 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 load pause population analysis?

Unknown Executive

Yes. Thanks for the questions. Regarding the DLB study, we have been considering trials of about 750 participants when we initially planned the study and this was targeting symptoms that include 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 we can come back to a well-powered registrational trial with less than half of this original number of participants. Regarding the START trial, we have not released or even analyzed the baseline data in order to compare it to the SHINE study. There will be a detention at the CTAD meeting coming up in 2 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 [indiscernible] data will not be presented yet. Thank you very much.

Operator

Next question comes from the line of Ram Silverado with H.C.Wainwright.

Raghuram Selvaraju

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.

Anthony Caggiano

Yes, thanks for those questions. So people at DLB have hostesses and dilution, then 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. We certain types of [indiscernible] in 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 it's not restricted based on a particular type of hallucination or dilution. It's general and allows it to be really crafted towards each and every participant.

So indeed, people with DLB, their hallucinations and delusions worsen throughout the course of the disease. And the important thing that we did over the last year here is to work with the FDA to basically agree that whether you're looking at times or fluctuations or motor center, 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 dilutions over the last months, if that subject to the issues of fluctuations that these other measures are, so it's a very good clinical tool to use. So that's why we're using this as a general measure of disease progression.

Lisa Ricciardi

Ram, 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 and hallucinations of several nature. One of the things they talk a lot is about smell. I'm selling bird coast. That seemed to be a common thing, surprisingly other hallucinations our oral AURA, why is the American -- the [indiscernible] banner playing all day long. There are visual hallucinations. I've heard repeatedly from physicians about patient people with DLB commenting on trains running through the back there are children coming to the home for things of this nature. Now they're largely not bothered by these things. but it does take them a while to come forward and talk about it.

On the dilution side, I think it's pretty straight forward what's most common [indiscernible] 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 the 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.

Raghuram Selvaraju

And then just with respect to the risk-benefit profile that you expect to target with zervimesine . Lisa, you mentioned during your prepared remarks that atypical antipsychotics has historically been used 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. These are not side effects that are associated with zervimesine or the class of drug towards urban belongs. So would you deem that to be potentially a future meaningful clinical and competitive edge for zervimisine were it to be approved in DLB?

Lisa Ricciardi

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, Rob, 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, let's 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. And so we believe that coming forward with a drug that can treat this population and have 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 to think about it in 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.

Operator

Thank you. There's no further question at this time. And now I will turn the call back to Cognitions's CEO, for closing remarks. Ms. Ricciardi, please go ahead.

Lisa Ricciardi

Thank you. In closing, I want to reiterate how excited we are to be able to advance zervimesine 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 Neuro Science concluded with the regulatory path for revenue. 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 advisers clinical trial investigators and our staff. Thank you for joining us. I'll turn the call back to the operator to conclude our call.

Operator

That concludes today's call. You may now disconnect.