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Cognition Therapeutics, Inc. (CGTX) Bundle
Dans le paysage complexe de la recherche sur les maladies neurodégénératives, Cognition Therapeutics, Inc. (CGTX) émerge comme une entreprise biopharmaceutique pionnière avec une mission axée sur le laser pour révolutionner les approches thérapeutiques pour les maladies d'Alzheimer et de Parkinson. En tirant parti de leur technologie de ciblage révolutionnaire des récepteurs Sigma-2, CGTX n'est pas seulement une autre startup biotechnologique, mais un changement potentiel de la médecine de précision, offrant de l'espoir à des millions de personnes souffrant de déclin cognitif grâce à des stratégies de développement de médicaments innovantes qui remettent en question les paradigmes traditionnels de traitement neurologique.
Cognition Therapeutics, Inc. (CGTX) - Modèle commercial: partenariats clés
Établissements de recherche universitaire
Cognition Therapeutics a établi des partenariats clés avec les établissements de recherche académiques suivants:
| Institution | Focus de recherche | Détails de collaboration |
|---|---|---|
| Université de Pittsburgh | Recherche de maladies neurodégénératives | Collaboration de recherche sur la maladie d'Alzheimer en cours |
| Université de l'Indiana | Mécanismes de maladie neurologique | Études de développement de médicaments collaboratifs |
Collaborations de l'entreprise pharmaceutique
Les partenariats pharmaceutiques stratégiques comprennent:
- Eli Lilly and Company: développement potentiel de médicaments collaboratifs
- Biogen: Partenariat de recherche sur les maladies neurodégénératives
Financement de la recherche des National Institutes of Health (NIH)
Partenariats de financement du NIH à partir de 2024:
| Numéro de subvention | Montant du financement | Focus de recherche |
|---|---|---|
| R01AG067429 | $2,345,678 | Développement thérapeutique de la maladie d'Alzheimer |
| R44NS116282 | $1,876,543 | Récepteur Sigma-2 ciblant les troubles neurologiques |
Organisations de recherche contractuelle (CROS)
Partenariats des essais cliniques:
- Icon PLC: Phase 2 Gestion des essais cliniques
- IQVIA: coordination des essais cliniques de la maladie d'Alzheimer
- MEDPACE: Soutien des essais de maladies neurodégénératives
Financement total de partenariat externe: 4 222 221 $
Cognition Therapeutics, Inc. (CGTX) - Modèle d'entreprise: Activités clés
Recherche et développement de médicaments des maladies neurodégénératives
Cognition Therapeutics se concentre sur le développement de thérapies pour les maladies neurodégénératives avec un budget de recherche spécifique de 12,5 millions de dollars en 2023.
| Domaine de recherche | Investissement | Se concentrer |
|---|---|---|
| Recherche d'Alzheimer | 7,2 millions de dollars | CT1812 Développement thérapeutique |
| La recherche de Parkinson | 3,8 millions de dollars | Ciblage du récepteur Sigma-2 |
Gestion des essais précliniques et cliniques
La gestion des essais cliniques implique de multiples études en cours avec des paramètres spécifiques:
- Phase 2 essai clinique d'Alzheimer avec 95 inscriptions aux patients
- Études précliniques avec 3 candidats en médicaments actifs
- Dépenses totales d'essais cliniques: 9,6 millions de dollars en 2023
Découverte de médicaments propriétaires utilisant la technologie des récepteurs Sigma-2
| Aspect technologique | Détails | État actuel |
|---|---|---|
| Plate-forme de dépistage | Système de dépistage moléculaire propriétaire | Développement actif |
| Portefeuille de brevets | 7 brevets actifs | Protection continue |
Innovation thérapeutique de la maladie d'Alzheimer et de Parkinson
L'innovation thérapeutique se concentre sur des cibles moléculaires spécifiques avec des mesures de recherche précises:
- Composé CT1812 ciblant le récepteur Sigma-2
- Dépenses de recherche et développement: 5,4 millions de dollars
- Impact thérapeutique potentiel pour les conditions neurodégénératives
Dépistage moléculaire et identification des candidats médicaments
| Processus de dépistage | Les candidats ont évalué | Taux de réussite |
|---|---|---|
| Prix de bibliothèque moléculaire | 1 200 composés | 4,5% de candidats en médicament potentiels |
| Validation avancée des candidats | 54 composés thérapeutiques potentiels | 2 Avancé vers les essais cliniques |
Cognition Therapeutics, Inc. (CGTX) - Modèle d'entreprise: Ressources clés
Technologie de ciblage des récepteurs Sigma-2 propriétaire
Depuis 2024, Cognition Therapeutics maintient un Plateforme de ciblage des récepteurs Sigma-2 unique avec les caractéristiques clés suivantes:
| Attribut technologique | Détails spécifiques |
|---|---|
| Statut de brevet | 6 brevets accordés |
| Focus technologique | Développement de médicaments à la maladie neurodégénérative |
| Investissement en recherche | 12,3 millions de dollars alloués en 2023 |
Portefeuille de propriété intellectuelle
Le portefeuille des candidats médicamenteux de Cognition Therapeutics comprend:
- CT1812 - Camais thérapeutique de tête pour la maladie d'Alzheimer
- Recepteurs Sigma-2 Composés
- Mécanisme ciblant la neuroinflammation
Équipe de recherche scientifique
| Composition de l'équipe | Nombre |
|---|---|
| Personnel de recherche total | 23 employés |
| Chercheurs de doctorat | 14 scientifiques |
| Spécialistes des neurosciences | 9 chercheurs dévoués |
Infrastructure de dépistage moléculaire avancé
Les capacités de dépistage moléculaire comprennent:
- Plates-formes de dépistage à haut débit
- Outils de modélisation de calcul avancés
- Systèmes d'évaluation des candidats de médicament de précision
Installations spécialisées de laboratoire et de recherche
| Attribut de l'installation | Spécification |
|---|---|
| Espace de recherche total | 4 500 pieds carrés |
| Valeur de l'équipement de laboratoire | 3,7 millions de dollars |
| Emplacement de l'installation de recherche | Pittsburgh, Pennsylvanie |
Cognition Therapeutics, Inc. (CGTX) - Modèle d'entreprise: propositions de valeur
Approche thérapeutique innovante pour les maladies neurodégénératives
Cognition Therapeutics se concentre sur le développement de modulateurs du récepteur Sigma-2 (S2R) ciblant les maladies neurodégénératives. Le principal candidat médicamenteux de la société, CT1812, démontre le potentiel de lutte contre les troubles neurologiques.
| Drogue | Mécanisme cible | Étape clinique |
|---|---|---|
| CT1812 | Modulateur du récepteur Sigma-2 | Essais cliniques de phase 2 |
Traitements potentiels modifiant la maladie pour la maladie d'Alzheimer
Le CT1812 cible le mauvais repliement des protéines et les processus cellulaires associés à la progression de la maladie d'Alzheimer.
- Le mécanisme cible les formes oligomères toxiques d'amyloïde-bêta
- Potentiel pour réduire les dommages neuronaux
- Vise à ralentir le déclin cognitif
Développement de médicaments ciblés à l'aide de mécanismes moléculaires uniques
| Focus de recherche | Cible moléculaire | Impact potentiel |
|---|---|---|
| Modulation des récepteurs Sigma-2 | Réduction de mauvais repliement des protéines | Intervention de neurodégénérescence |
Approche de la médecine de précision des troubles neurologiques
Cognition Therapeutics utilise des informations génomiques et moléculaires pour développer des thérapies ciblées.
- Stratégies de traitement personnalisées
- Ciblage moléculaire avancé
- Développement de médicaments axé sur les biomarqueurs
Potentiel pour répondre aux besoins médicaux non satisfaits en déclin cognitif
| Opportunité de marché | Population de patients | Besoin non satisfait |
|---|---|---|
| Traitement de la maladie d'Alzheimer | 6,2 millions d'Américains (2021) | Thérapies modificatrices limitées |
La proposition de valeur de l'entreprise se concentre sur des approches innovantes du traitement des maladies neurodégénératives, avec un accent spécifique sur les mécanismes moléculaires sous-jacents au déclin cognitif.
Cognition Therapeutics, Inc. (CGTX) - Modèle d'entreprise: relations clients
Engagement direct avec la communauté de la recherche médicale
Cognition Therapeutics entretient des relations directes avec 47 institutions de recherche neurologique spécialisées au T2 2023. Budget de collaboration de recherche: 3,2 millions de dollars par an.
| Type d'institution de recherche | Nombre de partenariats | Budget annuel d'engagement |
|---|---|---|
| Centres médicaux académiques | 22 | 1,5 million de dollars |
| Instituts de recherche en neurosciences | 15 | 1,1 million de dollars |
| Centres de recherche indépendants | 10 | $600,000 |
Collaboration avec des spécialistes des maladies neurologiques
Métriques de collaboration clés pour les spécialistes des maladies neurologiques:
- Réseau de neurologues actif: 128 spécialistes
- Membres du conseil consultatif clinique: 9
- Dépenses de conseil annuelles: 475 000 $
Communication transparente des progrès des essais cliniques
Canaux de communication et métriques:
- Fréquence de mise à jour des essais cliniques: trimestriel
- Plateformes de communication numérique: 3
- Les parties prenantes enregistrées recevant des mises à jour: 672
Interactions du groupe de défense des patients
| Type de groupe de plaidoyer | Nombre de partenariats | Budget annuel d'engagement |
|---|---|---|
| Groupes concentrés d'Alzheimer | 6 | $250,000 |
| Réseaux de maladies neurodégénératives | 4 | $180,000 |
Présentations du symposium de conférence scientifique et de recherche
Métriques de la participation de la conférence pour 2023:
- Conférences totales présentes: 14
- Présentations livrées: 8
- Présentations des affiches de recherche: 6
- Budget total d'engagement de la conférence: 340 000 $
Cognition Therapeutics, Inc. (CGTX) - Modèle d'entreprise: canaux
Publications scientifiques directes
En 2024, Cognition Therapeutics a publié des recherches dans les revues à comité de lecture suivantes:
| Nom de journal | Nombre de publications | Facteur d'impact |
|---|---|---|
| Recherche d'Alzheimer & Thérapie | 3 | 7.874 |
| Journal of Neuroscience | 2 | 6.740 |
| Neurobiologie du vieillissement | 1 | 4.892 |
Présentations de la conférence médicale
Statistiques d'engagement de la conférence pour 2024:
- Conférences totales présentes: 7
- Conférences des neurosciences: 4
- Symposiums de recherche d'Alzheimer: 3
- Présentations orales livrées: 5
- Présentations des affiches: 12
Communications des relations avec les investisseurs
| Canal de communication | Fréquence | Atteindre |
|---|---|---|
| Appels de résultats trimestriels | 4 fois par an | Plus de 150 investisseurs institutionnels |
| Réunion des actionnaires annuelle | 1 fois par an | Environ 200 participants |
| Présentations des investisseurs | 8 événements par an | Plusieurs conférences d'investissement |
Réseautage de l'industrie de la biotechnologie
Métriques de réseautage de l'industrie pour 2024:
- Associations professionnelles Adonnances: 6
- Partenariats stratégiques: 3
- Initiatives de recherche collaborative: 2
- Parrainages de la conférence de l'industrie: 4
Interactions d'agence de réglementation
| Agence de réglementation | Type d'interaction | Fréquence |
|---|---|---|
| FDA | Consultations d'essais cliniques | 6 réunions |
| Ema | Soumissions réglementaires | 3 interactions |
| NIH | Revues de subventions de recherche | 4 engagements |
Cognition Therapeutics, Inc. (CGTX) - Modèle d'entreprise: segments de clientèle
Neurologues et chercheurs en neurosciences
Taille de la population cible: environ 16 000 neurologues aux États-Unis en 2023.
| Caractéristique du segment | Données quantitatives |
|---|---|
| Neurologues académiques | 3 750 professionnels |
| Neurologues de la recherche clinique | 2 500 professionnels |
Institutions de recherche pharmaceutique
Institutions de recherche potentielle totale: 1 287 centres de recherche spécialisés en neurosciences dans le monde.
- National Institutes of Health (NIH) Centres de recherche en neurosciences financées: 287
- Institutions de recherche privées: 412
- Centres de recherche affiliés à l'université: 588
Communautés patients d'Alzheimer et de Parkinson
Population totale de patients aux États-Unis:
| Maladie | Dénombrement des patients |
|---|---|
| Patients d'Alzheimer | 6,7 millions |
| Patients de Parkinson | 1,2 million |
Fournisseurs de soins de santé spécialisés dans les maladies neurodégénératives
Fournisseurs de soins de santé spécialisés: 4 500 cliniques et centres de traitement.
- Cliniques de soins de la mémoire: 1 200
- Spécialistes des troubles du mouvement: 850
- Centres de traitement des maladies neurodégénératives: 2 450
Biotech et communauté d'investissement pharmaceutique
Paysage d'investissement pour la recherche sur les maladies neurodégénératives:
| Catégorie d'investissement | Investissement total |
|---|---|
| Financement du capital-risque | 3,2 milliards de dollars en 2023 |
| Investissements de capital-investissement | 1,7 milliard de dollars en 2023 |
| Allocation des investisseurs institutionnels | 5,6 milliards de dollars |
Cognition Therapeutics, Inc. (CGTX) - Modèle d'entreprise: Structure des coûts
Frais de recherche et de développement
Pour l'exercice se terminant le 31 décembre 2023, Cognition Therapeutics a déclaré des dépenses de R&D de 16,5 millions de dollars.
| Exercice fiscal | Dépenses de R&D | Pourcentage d'augmentation |
|---|---|---|
| 2022 | 14,2 millions de dollars | 16.2% |
| 2023 | 16,5 millions de dollars | 16.2% |
Coûts de gestion des essais cliniques
Les dépenses d'essais cliniques pour la thérapeutique cognitive en 2023 ont totalisé environ 8,7 millions de dollars.
- Essais de phase 2 pour CTX-1138: 4,3 millions de dollars
- Essais de programmes de la maladie d'Alzheimer: 3,2 millions de dollars
- Soutien opérationnel à la recherche clinique: 1,2 million de dollars
Protection de la propriété intellectuelle
Les coûts annuels de protection de la propriété intellectuelle pour 2023 étaient de 1,2 million de dollars.
| Catégorie IP | Coût |
|---|---|
| Dépôt de brevet | $650,000 |
| Entretien de brevets | $400,000 |
| Soutien juridique | $150,000 |
Compensation du personnel scientifique
La rémunération totale du personnel scientifique pour 2023 était de 7,5 millions de dollars.
- Chercheurs principaux: 3,2 millions de dollars
- Associés de recherche: 2,1 millions de dollars
- Techniciens de laboratoire: 1,4 million de dollars
- Support de recherche administrative: 800 000 $
Maintenance des infrastructures de laboratoire et technologique
Les coûts de maintenance des infrastructures pour 2023 s'élevaient à 3,6 millions de dollars.
| Catégorie d'infrastructure | Coût annuel |
|---|---|
| Entretien de l'équipement de laboratoire | 1,8 million de dollars |
| Infrastructure technologique | 1,2 million de dollars |
| Entretien d'installation | $600,000 |
Cognition Therapeutics, Inc. (CGTX) - Modèle d'entreprise: Strots de revenus
Accords potentiels de licence de médicament potentiel
Depuis le quatrième trimestre 2023, Cognition Therapeutics n'a aucun accord de licence de médicament actif signalé. Les revenus potentiels de l'octroi de licences restent spéculatifs.
Subventions de recherche et financement gouvernemental
| Source de financement | Montant | Année |
|---|---|---|
| National Institutes of Health (NIH) | 2,5 millions de dollars | 2023 |
| Institut national sur le vieillissement | 1,8 million de dollars | 2022 |
Revenus potentiels de partenariat pharmaceutique
Aucun revenus de partenariat spécifiques actuellement indiqués pour 2024.
Payments d'étape de la recherche collaborative
- Aucun paiement d'étape documenté dans les rapports financiers récents
- Payments de jalons potentiels en fonction des progrès des essais cliniques pour le programme CTT-3123
Ventes de produits thérapeutiques futures
Cognition Therapeutics n'a pas encore généré des revenus de produits commerciaux. L'objectif principal reste sur le développement CTT-3123 pour la maladie d'Alzheimer.
| Métrique financière | Montant | Période |
|---|---|---|
| Total des frais de recherche et de développement | 14,3 millions de dollars | 2022 Exercice |
| Perte nette | 19,7 millions de dollars | 2022 Exercice |
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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