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Cognition Therapeutics, Inc. (CGTX): Business Model Canvas |
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Cognition Therapeutics, Inc. (CGTX) Bundle
In der komplexen Landschaft der neurodegenerativen Krankheitsforschung entwickelt sich Cognition Therapeutics, Inc. (CGTX) zu einem bahnbrechenden biopharmazeutischen Unternehmen mit der laserfokussierten Mission, Therapieansätze für Alzheimer und Parkinson zu revolutionieren. Durch den Einsatz seiner bahnbrechenden Sigma-2-Rezeptor-Targeting-Technologie ist CGTX nicht nur ein weiteres Biotech-Startup, sondern ein potenzieller Game-Changer in der Präzisionsmedizin, der Millionen von Menschen, die unter kognitivem Verfall leiden, durch innovative Arzneimittelentwicklungsstrategien, die traditionelle neurologische Behandlungsparadigmen in Frage stellen, Hoffnung gibt.
Cognition Therapeutics, Inc. (CGTX) – Geschäftsmodell: Wichtige Partnerschaften
Akademische Forschungseinrichtungen
Cognition Therapeutics hat wichtige Partnerschaften mit den folgenden akademischen Forschungseinrichtungen aufgebaut:
| Institution | Forschungsschwerpunkt | Details zur Zusammenarbeit |
|---|---|---|
| Universität Pittsburgh | Forschung zu neurodegenerativen Erkrankungen | Laufende Forschungskooperation zur Alzheimer-Krankheit |
| Indiana-Universität | Neurologische Krankheitsmechanismen | Gemeinsame Studien zur Arzneimittelentwicklung |
Kooperationen mit Pharmaunternehmen
Zu den strategischen Pharmapartnerschaften gehören:
- Eli Lilly and Company: Mögliche gemeinsame Arzneimittelentwicklung
- Biogen: Forschungspartnerschaft für neurodegenerative Erkrankungen
Forschungsförderung der National Institutes of Health (NIH).
NIH-Finanzierungspartnerschaften ab 2024:
| Grant-Nummer | Förderbetrag | Forschungsschwerpunkt |
|---|---|---|
| R01AG067429 | $2,345,678 | Therapeutische Entwicklung der Alzheimer-Krankheit |
| R44NS116282 | $1,876,543 | Sigma-2-Rezeptor, der auf neurologische Störungen abzielt |
Auftragsforschungsinstitute (CROs)
Partnerschaften für klinische Studien:
- ICON plc: Management klinischer Phase-2-Studien
- IQVIA: Koordination klinischer Studien zur Alzheimer-Krankheit
- Medpace: Unterstützung bei Studien zu neurodegenerativen Erkrankungen
Gesamte externe Partnerschaftsfinanzierung: 4.222.221 USD
Cognition Therapeutics, Inc. (CGTX) – Geschäftsmodell: Hauptaktivitäten
Forschung und Entwicklung von Arzneimitteln für neurodegenerative Erkrankungen
Cognition Therapeutics konzentriert sich auf die Entwicklung von Therapien für neurodegenerative Erkrankungen mit einem spezifischen Forschungsbudget von 12,5 Millionen US-Dollar ab 2023.
| Forschungsbereich | Investition | Konzentrieren Sie sich |
|---|---|---|
| Alzheimer-Forschung | 7,2 Millionen US-Dollar | Therapeutische Entwicklung von CT1812 |
| Parkinson-Forschung | 3,8 Millionen US-Dollar | Targeting des Sigma-2-Rezeptors |
Präklinisches und klinisches Studienmanagement
Das Management klinischer Studien umfasst mehrere laufende Studien mit spezifischen Parametern:
- Klinische Phase-2-Studie zur Alzheimer-Krankheit mit 95 Patienten
- Präklinische Studien mit 3 aktiven Medikamentenkandidaten
- Gesamtausgaben für klinische Studien: 9,6 Millionen US-Dollar im Jahr 2023
Proprietäre Arzneimittelentwicklung mithilfe der Sigma-2-Rezeptortechnologie
| Technologieaspekt | Details | Aktueller Status |
|---|---|---|
| Screening-Plattform | Proprietäres molekulares Screening-System | Aktive Entwicklung |
| Patentportfolio | 7 aktive Patente | Kontinuierlicher Schutz |
Therapeutische Innovationen für die Alzheimer- und Parkinson-Krankheit
Therapeutische Innovation konzentriert sich auf spezifische molekulare Ziele mit präzisen Forschungsmetriken:
- CT1812-Verbindung, die auf den Sigma-2-Rezeptor abzielt
- Forschungs- und Entwicklungsausgaben: 5,4 Millionen US-Dollar
- Mögliche therapeutische Wirkung bei neurodegenerativen Erkrankungen
Molekulares Screening und Identifizierung von Arzneimittelkandidaten
| Screening-Prozess | Kandidaten bewertet | Erfolgsquote |
|---|---|---|
| Molekulares Bibliotheksscreening | 1.200 Verbindungen | 4,5 % potenzielle Medikamentenkandidaten |
| Erweiterte Kandidatenvalidierung | 54 potenzielle therapeutische Verbindungen | 2 bis zur klinischen Prüfung fortgeschritten |
Cognition Therapeutics, Inc. (CGTX) – Geschäftsmodell: Schlüsselressourcen
Proprietäre Sigma-2-Rezeptor-Targeting-Technologie
Ab 2024 unterhält Cognition Therapeutics eine einzigartige Sigma-2-Rezeptor-Targeting-Plattform mit folgenden Hauptmerkmalen:
| Technologieattribut | Spezifische Details |
|---|---|
| Patentstatus | 6 erteilte Patente |
| Technologiefokus | Entwicklung von Arzneimitteln für neurodegenerative Erkrankungen |
| Forschungsinvestitionen | Im Jahr 2023 werden 12,3 Millionen US-Dollar bereitgestellt |
Portfolio für geistiges Eigentum
Das Portfolio an Medikamentenkandidaten von Cognition Therapeutics umfasst:
- CT1812 – Führender therapeutischer Kandidat für die Alzheimer-Krankheit
- Verbindungen, die auf den Sigma-2-Rezeptor abzielen
- Mechanismus, der auf Neuroinflammation abzielt
Wissenschaftliches Forschungsteam
| Teamzusammensetzung | Nummer |
|---|---|
| Gesamtes Forschungspersonal | 23 Mitarbeiter |
| Doktoranden | 14 Wissenschaftler |
| Spezialisten für Neurowissenschaften | 9 engagierte Forscher |
Fortschrittliche Infrastruktur für molekulares Screening
Zu den molekularen Screening-Funktionen gehören:
- Hochdurchsatz-Screeningplattformen
- Erweiterte rechnergestützte Modellierungstools
- Präzise Systeme zur Bewertung von Arzneimittelkandidaten
Spezialisierte Labor- und Forschungseinrichtungen
| Einrichtungsattribut | Spezifikation |
|---|---|
| Gesamter Forschungsraum | 4.500 Quadratmeter |
| Wert der Laborausrüstung | 3,7 Millionen US-Dollar |
| Standort der Forschungseinrichtung | Pittsburgh, Pennsylvania |
Cognition Therapeutics, Inc. (CGTX) – Geschäftsmodell: Wertversprechen
Innovativer Therapieansatz für neurodegenerative Erkrankungen
Cognition Therapeutics konzentriert sich auf die Entwicklung von Sigma-2-Rezeptor (S2R)-Modulatoren zur Bekämpfung neurodegenerativer Erkrankungen. Der wichtigste Medikamentenkandidat des Unternehmens, CT1812, zeigt Potenzial für die Behandlung neurologischer Erkrankungen.
| Arzneimittelkandidat | Zielmechanismus | Klinisches Stadium |
|---|---|---|
| CT1812 | Sigma-2-Rezeptormodulator | Klinische Studien der Phase 2 |
Mögliche krankheitsmodifizierende Behandlungen für Alzheimer
CT1812 zielt auf Proteinfehlfaltungen und zelluläre Prozesse ab, die mit dem Fortschreiten der Alzheimer-Krankheit verbunden sind.
- Der Mechanismus zielt auf toxische oligomere Formen von Amyloid-Beta ab
- Potenzial zur Reduzierung neuronaler Schäden
- Zielt darauf ab, den kognitiven Verfall zu verlangsamen
Gezielte Arzneimittelentwicklung mithilfe einzigartiger molekularer Mechanismen
| Forschungsschwerpunkt | Molekulares Ziel | Mögliche Auswirkungen |
|---|---|---|
| Sigma-2-Rezeptormodulation | Reduzierung der Proteinfehlfaltung | Neurodegenerationsintervention |
Präzisionsmedizinischer Ansatz bei neurologischen Erkrankungen
Cognition Therapeutics nutzt genomische und molekulare Erkenntnisse, um zielgerichtete Therapien zu entwickeln.
- Personalisierte Behandlungsstrategien
- Erweitertes molekulares Targeting
- Biomarker-gesteuerte Arzneimittelentwicklung
Potenzial zur Bewältigung ungedeckter medizinischer Bedürfnisse bei kognitivem Verfall
| Marktchance | Patientenpopulation | Ungedeckter Bedarf |
|---|---|---|
| Behandlung der Alzheimer-Krankheit | 6,2 Millionen Amerikaner (2021) | Begrenzte krankheitsmodifizierende Therapien |
Das Wertversprechen des Unternehmens konzentriert sich auf innovative Ansätze zur Behandlung neurodegenerativer Erkrankungen, mit besonderem Schwerpunkt auf den molekularen Mechanismen, die dem kognitiven Verfall zugrunde liegen.
Cognition Therapeutics, Inc. (CGTX) – Geschäftsmodell: Kundenbeziehungen
Direkte Zusammenarbeit mit der medizinischen Forschungsgemeinschaft
Cognition Therapeutics unterhält seit dem vierten Quartal 2023 direkte Beziehungen zu 47 spezialisierten neurologischen Forschungseinrichtungen. Budget für Forschungszusammenarbeit: 3,2 Millionen US-Dollar pro Jahr.
| Art der Forschungseinrichtung | Anzahl der Partnerschaften | Jährliches Engagement-Budget |
|---|---|---|
| Akademische medizinische Zentren | 22 | 1,5 Millionen Dollar |
| Neurowissenschaftliche Forschungsinstitute | 15 | 1,1 Millionen US-Dollar |
| Unabhängige Forschungszentren | 10 | $600,000 |
Zusammenarbeit mit Spezialisten für neurologische Erkrankungen
Wichtige Kennzahlen für die Zusammenarbeit für Spezialisten für neurologische Erkrankungen:
- Aktives Neurologennetzwerk: 128 Spezialisten
- Mitglieder des Klinischen Beirats: 9
- Jährliche Beratungsausgaben: 475.000 US-Dollar
Transparente Kommunikation des Fortschritts klinischer Studien
Kommunikationskanäle und Kennzahlen:
- Häufigkeit der Aktualisierung klinischer Studien: Vierteljährlich
- Digitale Kommunikationsplattformen: 3
- Registrierte Stakeholder, die Updates erhalten: 672
Interaktionen mit Patientenvertretungsgruppen
| Art der Interessenvertretung | Anzahl der Partnerschaften | Jährliches Engagement-Budget |
|---|---|---|
| Alzheimer-Fokusgruppen | 6 | $250,000 |
| Netzwerke für neurodegenerative Erkrankungen | 4 | $180,000 |
Präsentationen von wissenschaftlichen Konferenzen und Forschungssymposien
Kennzahlen zur Konferenzteilnahme für 2023:
- Gesamtzahl der besuchten Konferenzen: 14
- Vorträge gehalten: 8
- Forschungsposterpräsentationen: 6
- Gesamtbudget für die Teilnahme an der Konferenz: 340.000 US-Dollar
Cognition Therapeutics, Inc. (CGTX) – Geschäftsmodell: Kanäle
Direkte wissenschaftliche Veröffentlichungen
Seit 2024 hat Cognition Therapeutics Forschungsergebnisse in den folgenden peer-reviewten Fachzeitschriften veröffentlicht:
| Zeitschriftenname | Anzahl der Veröffentlichungen | Impact-Faktor |
|---|---|---|
| Alzheimer-Forschung & Therapie | 3 | 7.874 |
| Zeitschrift für Neurowissenschaften | 2 | 6.740 |
| Neurobiologie des Alterns | 1 | 4.892 |
Präsentationen auf medizinischen Konferenzen
Statistiken zum Konferenzengagement für 2024:
- Gesamtzahl der besuchten Konferenzen: 7
- Neurowissenschaftliche Konferenzen: 4
- Symposien zur Alzheimer-Forschung: 3
- Gehaltene mündliche Vorträge: 5
- Posterpräsentationen: 12
Investor-Relations-Kommunikation
| Kommunikationskanal | Häufigkeit | Reichweite |
|---|---|---|
| Vierteljährliche Gewinnaufrufe | 4 Mal im Jahr | Über 150 institutionelle Anleger |
| Jahreshauptversammlung | 1 Mal pro Jahr | Etwa 200 Teilnehmer |
| Investorenpräsentationen | 8 Veranstaltungen jährlich | Mehrere Investmentkonferenzen |
Vernetzung der Biotechnologiebranche
Kennzahlen zur Branchenvernetzung für 2024:
- Mitgliedschaften in Berufsverbänden: 6
- Strategische Partnerschaften: 3
- Verbundforschungsinitiativen: 2
- Sponsoring von Branchenkonferenzen: 4
Interaktionen mit Regulierungsbehörden
| Regulierungsbehörde | Interaktionstyp | Häufigkeit |
|---|---|---|
| FDA | Beratung zu klinischen Studien | 6 Treffen |
| EMA | Zulassungsanträge | 3 Interaktionen |
| NIH | Bewertungen von Forschungsstipendien | 4 Engagements |
Cognition Therapeutics, Inc. (CGTX) – Geschäftsmodell: Kundensegmente
Neurologen und Neurowissenschaftler
Zielpopulationsgröße: Ungefähr 16.000 Neurologen in den Vereinigten Staaten ab 2023.
| Segmentcharakteristik | Quantitative Daten |
|---|---|
| Akademische Neurologen | 3.750 Fachkräfte |
| Neurologen für klinische Forschung | 2.500 Fachkräfte |
Pharmazeutische Forschungseinrichtungen
Insgesamt potenzielle Forschungseinrichtungen: 1.287 spezialisierte neurowissenschaftliche Forschungszentren weltweit.
- Von den National Institutes of Health (NIH) finanzierte neurowissenschaftliche Forschungszentren: 287
- Private Forschungseinrichtungen: 412
- An die Universität angeschlossene Forschungszentren: 588
Patientengemeinschaften für Alzheimer und Parkinson
Gesamtpatientenpopulation in den Vereinigten Staaten:
| Krankheit | Patientenzahl |
|---|---|
| Alzheimer-Patienten | 6,7 Millionen |
| Parkinson-Patienten | 1,2 Millionen |
Auf neurodegenerative Erkrankungen spezialisierte Gesundheitsdienstleister
Spezialisierte Gesundheitsdienstleister: 4.500 Kliniken und Behandlungszentren.
- Kliniken für Gedächtnispflege: 1.200
- Spezialisten für Bewegungsstörungen: 850
- Behandlungszentren für neurodegenerative Erkrankungen: 2.450
Biotech- und Pharma-Investmentgemeinschaft
Investitionslandschaft für die Erforschung neurodegenerativer Erkrankungen:
| Anlagekategorie | Gesamtinvestition |
|---|---|
| Risikokapitalfinanzierung | 3,2 Milliarden US-Dollar im Jahr 2023 |
| Private-Equity-Investitionen | 1,7 Milliarden US-Dollar im Jahr 2023 |
| Allokation institutioneller Anleger | 5,6 Milliarden US-Dollar |
Cognition Therapeutics, Inc. (CGTX) – Geschäftsmodell: Kostenstruktur
Forschungs- und Entwicklungskosten
Für das am 31. Dezember 2023 endende Geschäftsjahr meldete Cognition Therapeutics Forschungs- und Entwicklungskosten in Höhe von 16,5 Millionen US-Dollar.
| Geschäftsjahr | F&E-Ausgaben | Prozentuale Erhöhung |
|---|---|---|
| 2022 | 14,2 Millionen US-Dollar | 16.2% |
| 2023 | 16,5 Millionen US-Dollar | 16.2% |
Kosten für das Management klinischer Studien
Die Ausgaben für klinische Studien für Cognition Therapeutics beliefen sich im Jahr 2023 auf rund 8,7 Millionen US-Dollar.
- Phase-2-Studien für CTX-1138: 4,3 Millionen US-Dollar
- Studien zum Alzheimer-Programm: 3,2 Millionen US-Dollar
- Betriebsunterstützung für die klinische Forschung: 1,2 Millionen US-Dollar
Schutz des geistigen Eigentums
Die jährlichen Kosten für den Schutz geistigen Eigentums beliefen sich im Jahr 2023 auf 1,2 Millionen US-Dollar.
| IP-Kategorie | Kosten |
|---|---|
| Patentanmeldung | $650,000 |
| Patentpflege | $400,000 |
| Rechtliche Unterstützung | $150,000 |
Vergütung des wissenschaftlichen Personals
Die Gesamtvergütung des wissenschaftlichen Personals für 2023 betrug 7,5 Millionen US-Dollar.
- Leitende Forschungswissenschaftler: 3,2 Millionen US-Dollar
- Wissenschaftliche Mitarbeiter: 2,1 Millionen US-Dollar
- Labortechniker: 1,4 Millionen US-Dollar
- Administrative Forschungsunterstützung: 800.000 US-Dollar
Wartung der Labor- und Technologieinfrastruktur
Die Wartungskosten für die Infrastruktur beliefen sich im Jahr 2023 auf 3,6 Millionen US-Dollar.
| Kategorie „Infrastruktur“. | Jährliche Kosten |
|---|---|
| Wartung von Laborgeräten | 1,8 Millionen US-Dollar |
| Technologieinfrastruktur | 1,2 Millionen US-Dollar |
| Anlagenwartung | $600,000 |
Cognition Therapeutics, Inc. (CGTX) – Geschäftsmodell: Einnahmequellen
Mögliche zukünftige Arzneimittellizenzvereinbarungen
Im vierten Quartal 2023 wurden für Cognition Therapeutics keine aktiven Arzneimittellizenzvereinbarungen gemeldet. Mögliche Einnahmen aus der Lizenzierung bleiben spekulativ.
Forschungsstipendien und staatliche Förderung
| Finanzierungsquelle | Betrag | Jahr |
|---|---|---|
| National Institutes of Health (NIH) | 2,5 Millionen Dollar | 2023 |
| Nationales Institut für Altern | 1,8 Millionen US-Dollar | 2022 |
Potenzielle Einnahmen aus pharmazeutischen Partnerschaften
Für 2024 werden derzeit keine spezifischen Partnerschaftsumsätze gemeldet.
Meilensteinzahlungen aus Verbundforschung
- In aktuellen Finanzberichten sind keine Meilensteinzahlungen dokumentiert
- Mögliche Meilensteinzahlungen hängen vom Fortschritt der klinischen Studie für das CTT-3123-Programm ab
Zukünftiger Verkauf therapeutischer Produkte
Cognition Therapeutics hat noch keine kommerziellen Produktumsätze erzielt. Der Schwerpunkt liegt weiterhin auf der Entwicklung CTT-3123 für die Alzheimer-Krankheit.
| Finanzkennzahl | Betrag | Zeitraum |
|---|---|---|
| Gesamte Forschungs- und Entwicklungskosten | 14,3 Millionen US-Dollar | Geschäftsjahr 2022 |
| Nettoverlust | 19,7 Millionen US-Dollar | Geschäftsjahr 2022 |
Cognition Therapeutics, Inc. (CGTX) - Canvas Business Model: Value Propositions
You're looking at the core promise Cognition Therapeutics, Inc. (CGTX) is making to patients and the market with its lead asset, zervimesine (CT1812). This isn't about abstract potential; it's about concrete delivery and measurable biological impact as of late 2025.
The primary value proposition centers on zervimesine being an investigational, oral, once-daily pill for serious neurodegenerative disorders like Alzheimer's disease (AD) and Dementia with Lewy Bodies (DLB). This oral dosing is a significant differentiator in a space often reliant on infusions or less convenient regimens.
The mechanism is novel because it aims to protect synapses by interrupting the toxic effects of misfolded proteins. Specifically, zervimesine has been shown to interrupt the toxic effects of A$\beta$ and $\alpha$-synuclein, which are implicated in both AD and DLB pathology. The drug operates through interaction with the sigma-2 receptor, a mechanism functionally distinct from many other approaches currently in development for these diseases.
For Alzheimer's disease, the value proposition is sharpened by a predictive biomarker strategy. Cognition Therapeutics has data suggesting that the drug's benefit is most pronounced in patients with lower baseline levels of the protein p-tau217, which is measurable via a simple blood test. This enrichment strategy is key for future registrational trials, as it targets patients most likely to show a robust treatment effect.
Here is a snapshot of the key clinical performance metrics supporting this value proposition:
| Indication/Study | Patient Subgroup | Endpoint/Measure | Observed Effect vs. Placebo |
| Alzheimer's Disease (Phase 2 SHINE) | Overall Population | Slowing of Cognitive Decline | 38% |
| Alzheimer's Disease (Phase 2 SHINE) | Lower Plasma p-tau217 Levels | Slowing of Cognitive Decline (ADAS-Cog11) | 95% |
| Dementia with Lewy Bodies (Phase 2 SHIMMER) | Overall DLB Patients (6 months) | Improvement on Neuropsychiatric Inventory (NPI-12) | Average of 86% better |
| Dry Age-Related Macular Degeneration (Phase 2) | Overall Population (18 months) | Reduction of Geographic Atrophy (GA) Lesion Growth | 28.6% |
The company is actively advancing the DLB indication, having initiated an Expanded Access Program (EAP) for patients with DLB. Furthermore, as of the third quarter of 2025, Cognition Therapeutics was anticipating an FDA decision on breakthrough designation for zervimesine in DLB in the third quarter 2025.
To support this pipeline momentum, Cognition Therapeutics completed a $30 million registered direct offering in the third quarter of 2025. Financially, as of September 30, 2025, the company reported cash, cash equivalents, and restricted cash of approximately $39.8 million, supplemented by $36.3 million in remaining obligated grant funds from the National Institute on Aging. This position allowed the company to estimate sufficient cash to fund operations into the second quarter of 2027.
The AD program is also progressing with a large trial. The Phase 2 START Study, testing zervimesine in mild cognitive impairment (MCI) or early AD, surpassed 75% enrollment as of September 2025, enrolling approximately 540 individuals.
You should track the following key elements:
- The FDA's decision on breakthrough designation for DLB, which was expected in Q3 2025.
- The expected readout timeline for the Phase 2 START study, which involves an 18-month treatment period.
- The company's cash burn rate, given the net loss for Q3 2025 was $4.9 million.
- The alignment achieved with the FDA on a registrational path for AD, which may require two six-month Phase 3 studies.
Cognition Therapeutics, Inc. (CGTX) - Canvas Business Model: Customer Relationships
You're looking at the relationships Cognition Therapeutics, Inc. (CGTX) builds with the key groups that drive its clinical and financial success. For a clinical-stage biotech, these aren't just customers; they are partners in development and validation.
Close collaboration with clinical investigators and academic sites
The execution of clinical trials relies heavily on strong ties with the medical community. Cognition Therapeutics, Inc. works closely with established consortia and specific investigators to run its studies on zervimesine (CT1812).
The Phase 2 START study, evaluating zervimesine in early Alzheimer's disease, is being conducted in partnership with colleagues at the Alzheimer's Clinical Trials Consortium (ACTC). As of September 3, 2025, this study had surpassed 75% enrollment of its target of about 540 participants. Full enrollment was announced by November 13, 2025.
For the Phase 2 SHIMMER study in dementia with Lewy bodies (DLB), the enrollment breakdown showed significant engagement:
| Study Arm | Number of Participants Randomized |
| Zervimesine Treatment Arms (100 mg or 300 mg daily) | 88 |
| Placebo Arm | 42 |
| Total Enrolled (SHIMMER) | 130 |
Key investigators involved in these programs include Dr. James E. Galvin of the University of Miami Miller School of Medicine and Dr. Lawrence S. Honig of Columbia University Irving Medical Center.
High-touch engagement with regulatory bodies (FDA, EMA)
Engagement with the U.S. Food and Drug Administration (FDA) is critical for defining the path to market. Cognition Therapeutics, Inc. has secured key agreements that shape its near-term development strategy.
The company achieved alignment with the FDA on a registrational path in Alzheimer's disease following a productive end-of-Phase 2 meeting on July 9, 2025. This agreement suggests that two six-month Phase 3 studies, with participants randomized 1:1 to receive either 100 mg of oral zervimesine or placebo daily, may be sufficient to support a New Drug Application (NDA) filing.
For the DLB indication, the company is pursuing similar input. The FDA has accepted a request for a Type C meeting, scheduled for the second half of January 2026, to discuss the proposed Phase 3 program design for zervimesine in DLB patients.
The high-touch regulatory interaction extends globally, as Cognition Therapeutics, Inc. is planning a scientific advice meeting with the European Medicines Agency (EMA) in February 2026 to align its global Alzheimer's disease registrational plans.
Expanded Access Program (EAP) for DLB patients
The Expanded Access Program (EAP), designated COG1202, provides access to zervimesine for eligible patients with mild-to-moderate DLB outside of a formal trial setting. This program demonstrates a commitment to patients with high unmet need.
The program reached full enrollment as of December 3, 2025, completing enrollment in just three months. The EAP was made possible through a generous philanthropic donation from the family of a former Phase 2 SHIMMER participant.
- Treatment regimen: 100 mg of oral zervimesine daily for up to one year.
- Initial plan targeted approximately 30 patients.
- The program onboarded three clinical sites as of Q2 2025, with the first of eight total sites being Banner Sun Health Research Institute in Arizona.
Investor relations and capital market communications
Maintaining strong relationships with capital providers is essential for funding the late-stage clinical development required for a registrational program. Cognition Therapeutics, Inc. actively engaged the capital markets in 2025.
On September 2, 2025, the Company closed a $30 million registered direct offering, which involved the sale of 14,700,000 shares of common stock to institutional investors. This capital infusion provided significant runway extension.
Key financial and investor metrics as of late 2025:
| Metric | Value/Date |
| Market Capitalization (as of Dec 3, 2025) | $142 million |
| Cash, Cash Equivalents, Restricted Cash (as of Sep 30, 2025) | Approx. $39.8 million |
| Estimated Cash Runway (as of Sep 30, 2025) | Into the second quarter of 2027 |
| Total Obligated Grant Funds Remaining (as of Sep 30, 2025) | $36.3 million (from NIA) |
Investor engagement included participation in the 37th Annual Piper Sandler Healthcare Conference from December 2-4, 2025.
Cognition Therapeutics, Inc. (CGTX) - Canvas Business Model: Channels
You're looking at how Cognition Therapeutics, Inc. (CGTX) gets its science and its potential product, zervimesine (CT1812), out to the world-from the lab bench to the potential patient and the institutional investor. This is all about execution and communication channels for a clinical-stage company.
Global network of clinical trial sites and research institutions
The core of the channel strategy revolves around clinical execution. You can't get to an NDA without running high-quality trials, and that requires a network. The Phase 2 START Study, which is testing zervimesine in mild cognitive impairment (MCI) or early Alzheimer's disease, is a prime example of this channel in action.
This study is being run in collaboration with the Alzheimer's Clinical Trials Consortium (ACTC). That consortium is an NIA-funded clinical trial network comprising 35 leading academic sites specializing in Alzheimer's disease trials. It's a powerful channel for recruitment and site management. The ACTC partnership is key, especially since the START Study is supported by an $81 million grant from the National Institute on Aging (NIA) at the National Institutes of Health. The company reached its target enrollment of 540 participants in this Phase 2 study as of November 13, 2025. To be fair, the previous Phase 2 SHINE study was smaller, enrolling 153 adults with mild-to-moderate Alzheimer's disease, but the START enrollment shows scaling in this channel.
Here's a quick look at the scale of their clinical channel activity through late 2025:
| Trial/Program | Target Indication | Enrollment Status (as of late 2025) | Key Collaborator/Network |
|---|---|---|---|
| Phase 2 START Study | Early Alzheimer's Disease (MCI/early AD) | Target enrollment of 540 participants reached (Nov 13, 2025) | Alzheimer's Clinical Trials Consortium (ACTC) |
| Phase 3 Registrational Program | Mild-to-Moderate Alzheimer's Disease | Design agreed upon with FDA; planning two six-month studies | U.S. FDA (via July 2025 EOP2 meeting) |
| Expanded Access Program (EAP) | Dementia with Lewy Bodies (DLB) | Full enrollment reached (Dec 3, 2025) | Various clinical sites/donors |
Regulatory submissions (NDA) to the U.S. FDA and other agencies
The regulatory pathway is the most critical channel for commercialization. Cognition Therapeutics, Inc. has made significant strides here. They completed an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on July 9, 2025, for their Alzheimer's program. The outcome was a clear channel to market: the FDA confirmed that the proposed Phase 3 design could support a New Drug Application (NDA) filing for zervimesine as an Alzheimer's treatment. This framework relies on two six-month Phase 3 trials using enrichment for patients with lower plasma p-tau217 levels. Also, they applied to the FDA for breakthrough designation for zervimesine in DLB, with an expected decision in the third quarter of 2025. For global alignment, they plan an EMA scientific advice meeting in February 2026.
Scientific and medical conferences (e.g., CTAD) for data dissemination
Disseminating data effectively is how Cognition Therapeutics builds credibility with clinicians and researchers, which, in turn, drives investigator interest and patient enrollment. They actively use major medical meetings as a primary channel.
The most recent, and perhaps most important, dissemination event was presenting the Phase 3 registrational plan at the Clinical Trials on Alzheimer's Disease (CTAD) conference on December 1, 2025, in San Diego, CA. Earlier in 2025, results from the Phase 2 SHIMMER study in DLB were presented at the Alzheimer's Association International Congress (AAIC) on July 29th in Toronto, Canada. This conference activity directly fueled enrollment acceleration in the START study, with approximately 50% of the entire study population enrolled during the last six months of 2025.
The key data dissemination channels include:
- Presenting Phase 3 plan at CTAD (December 1, 2025).
- Presenting Phase 2 DLB data at AAIC (July 29, 2025).
- Participation in the 37th Annual Piper Sandler Healthcare Conference (December 2-4, 2025).
- Live presentation by the CEO at the Life Sciences Virtual Investor Conference (March 13, 2025).
Investor roadshows and direct communication with institutional investors
Securing capital is a crucial channel for a clinical-stage company. Cognition Therapeutics, Inc. actively engaged institutional investors throughout 2025. A major event was closing a $30 Million Registered Direct Offering on September 2, 2025, which involved two new fundamental institutional investors, including a preeminent global investment firm. This capital supports the planned Phase 3 development. Furthermore, the President and CEO, Lisa Ricciardi, delivered a live presentation at the Life Sciences Virtual Investor Conference on March 13, 2025, at 9:30 a.m. ET. This direct engagement channel helps manage expectations and secure necessary funding, as evidenced by the $30 million raised in September. Finance: draft 13-week cash view by Friday.
Cognition Therapeutics, Inc. (CGTX) - Canvas Business Model: Customer Segments
You're looking at the specific groups Cognition Therapeutics, Inc. (CGTX) targets with its investigational drug zervimesine, which is key for understanding their near-term commercial focus and investor appeal.
Patients with early Alzheimer's disease (MCI/mild AD)
This segment represents a massive, underserved population where Cognition Therapeutics, Inc. (CGTX) is actively pursuing development with its lead candidate, zervimesine (CT1812). The company's Phase 2 START Study specifically targets this group, aiming for early intervention.
- Estimated 7.2 million Americans aged 65+ living with Alzheimer's dementia as of 2025.
- Approximately 1.9 million of those cases are in the 65 to 74 year age bracket, aligning with the early-stage focus.
- The Phase 2 START Study is targeting 540 participants.
- In a survey, 92% of Americans indicated they would take a treatment that could slow disease progression.
The company also completed Phase 2 studies for mild-to-moderate Alzheimer's disease via the SHINE trial.
Patients with Dementia with Lewy Bodies (DLB)
Cognition Therapeutics, Inc. (CGTX) is also focused on DLB, evidenced by the recent completion of enrollment in an expanded access program for zervimesine in this patient group. This shows a commitment to a distinct neurodegenerative indication.
- The expanded access program enrolled eligible patients to receive 100 mg of oral zervimesine daily for up to one year.
- The company has a scheduled Type C meeting with the FDA in the second half of January to discuss the proposed design for a Phase 3 program in DLB patients.
Clinical investigators and neurologists specializing in neurodegeneration
These professionals are crucial for trial execution, site selection, and ultimately, adoption of the therapy. Cognition Therapeutics, Inc. (CGTX) is actively engaged with key opinion leaders in the field.
Here's a look at the key personnel and funding sources involved in their clinical efforts:
| Role/Affiliation | Involvement/Detail | Associated Study/Program |
|---|---|---|
| Dr. James E. Galvin, MD, MPH | Lead investigator for the multi-center, open-label program. | DLB Expanded Access Program |
| Dr. Lawrence S. Honig | Investigator in the expanded access program. | DLB Expanded Access Program |
| National Institute of Aging (NIA) | Provided grant support for the Phase 2 START study. | Phase 2 START Study (Early AD) |
| Alzheimer's Clinical Trials Consortium | Collaboration partner for the START study. | Phase 2 START Study (Early AD) |
Institutional investors and public equity markets
The public market and institutional holders are the primary source of capital for this clinical-stage biopharma. Recent trading activity shows significant interest, though the company is operating under a tight cash runway.
Here are the key financial and ownership metrics as of late 2025:
| Metric | Value/Amount | Date/Context |
|---|---|---|
| Market Capitalization | About $158.9M | As of December 5, 2025 |
| Institutional Ownership Percentage | 28.9% | As of September 2025 filings |
| Estimated Cash Runway | Into the second quarter of 2026 | As of Q2 2025 results |
| Largest Institutional Holder (Shares) | 6.00Mn shares (BIOS Capital Management, LP) | As of September 30, 2025 |
| Largest Institutional Holder (Percentage) | 8.17% of outstanding stock | BIOS Capital Management, LP |
| Q3 2025 Stake Increase (Vanguard) | 105.6% increase | Vanguard Group Inc. |
| Q3 2025 New Stake Value (Davenport) | $3,631,000 | DAVENPORT & Co LLC |
| Consensus Analyst Price Target (Average) | $3.33 | Twelve-month forecast |
| Analyst Consensus Rating | Moderate Buy | Based on 5 analysts |
You can see institutional buying was strong in Q3 2025, with BlackRock, Inc. adding 891,844 shares, representing a 1160.4% increase in their position for that quarter. Still, the company's cash position as of June 30, 2025, was approximately $11.6 million, supplemented by $41.9 million in remaining NIA grant funds.
Cognition Therapeutics, Inc. (CGTX) - Canvas Business Model: Cost Structure
You're looking at the core expenses for Cognition Therapeutics, Inc. (CGTX) as they push zervimesine through later-stage development. For a clinical-stage biotech, the cost structure is heavily weighted toward the science, not selling products-that's the reality of this business phase.
The primary driver for Cognition Therapeutics, Inc. (CGTX) cost structure is Research and Development (R&D) expenses. This reflects the ongoing investment in clinical trials and preclinical work for their pipeline, especially zervimesine (CT1812).
Here's a quick look at the key operating expenses reported for the third quarter ended September 30, 2025:
| Expense Category | Q3 2025 Amount (in millions) | Q3 2024 Amount (in millions) |
| Research and Development (R&D) | $3.8 | $11.4 |
| General and Administrative (G&A) | $2.6 | $3.1 |
| Total Operating Expenses | $6.38 | $14.46 |
R&D expenses were reported at $3.8 million for Q3 2025. This figure represented a significant year-over-year decrease from $11.4 million in Q3 2024, driven by the completion of the SHINE and SHIMMER clinical trials and associated professional fees.
General and Administrative (G&A) expenses were $2.6 million for Q3 2025. That was down from $3.1 million in the comparable period of 2024, primarily due to lower stock-based compensation expenses.
Beyond the reported operating expenses, the cost structure necessarily includes other significant, though perhaps less granularly detailed in every release, expenditures essential for a company advancing drug candidates:
- Costs for manufacturing drug supply for clinical trials, ensuring sufficient quantities of zervimesine are available for ongoing and planned studies, including the registrational path programs.
- Regulatory compliance costs, which cover filings, interactions with the U.S. FDA, and adherence to global health authority requirements.
- Intellectual property maintenance costs, which are critical for securing and defending the patents around their novel small molecule therapeutics.
The net loss for the quarter ended September 30, 2025, was $4.9 million, or $(0.06) per basic and diluted share. This loss was significantly narrower than the net loss of $9.9 million, or $(0.25) per share, for Q3 2024, reflecting the lower operating expenses as major trials concluded.
Finance: draft 13-week cash view by Friday.
Cognition Therapeutics, Inc. (CGTX) - Canvas Business Model: Revenue Streams
You're hiring before product-market fit, which means Cognition Therapeutics, Inc.'s revenue streams are entirely non-commercial right now. The business model relies heavily on non-dilutive government funding and dilutive equity raises to keep the lights on while advancing zervimesine (CT1812) through clinical trials. Honestly, this is standard for a clinical-stage biotech, but you need to track the cash burn against these inflows.
The primary, non-dilutive source of operational support comes from the National Institute on Aging (NIA), a division of the National Institutes of Health (NIH). This grant income directly offsets operating expenses, though the draw-down rate can fluctuate.
- Grant income recognized from the National Institute on Aging (NIA/NIH) for the third quarter ended September 30, 2025, was $1.2 million.
- As of September 30, 2025, the total obligated grant funds remaining from the NIA/NIH stood at $36.3 million.
To bridge the gap between grant receipts and the high costs of late-stage clinical development, Cognition Therapeutics, Inc. turned to equity financing. They successfully executed a significant capital raise in the third quarter of 2025.
Here's the quick math on that equity event:
| Financing Event Detail | Amount/Value |
| Gross Proceeds from Registered Direct Offering | Approximately $30 million |
| Shares Sold | 14,700,000 shares of common stock |
| Purchase Price Per Share | $2.05 |
| Closing Date | September 2, 2025 |
This $30 million registered direct offering, which closed in September 2025, was crucial; it extended the company's estimated cash runway into the second quarter of 2027.
The third component of the revenue stream structure involves external partnerships, though these are prospective rather than realized income streams as of late 2025. Cognition Therapeutics, Inc. is actively evaluating options to support the development of zervimesine through strategic collaborations.
- Potential future milestone payments from strategic pharmaceutical licensing deals remain a key component of the long-term financial plan.
- The company is executing studies to support registrational programs, which are expected to be valuable to potential partners.
It is critical to note the current commercial status. Cognition Therapeutics, Inc. is a clinical-stage company; therefore, there is no current commercial product revenue.
- No top-line sales contribution is recognized; the model remains dependent on grants and capital markets.
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