Celcuity Inc. (CELC): Business Model Canvas [Jan-2025 Mise à jour]

Dans le paysage rapide en évolution de la médecine de précision, Celcuity Inc. (CELC) émerge comme un innovateur révolutionnaire, transformant le diagnostic de cancer par le profilage moléculaire sophistiqué et les technologies de calcul. En tirant parti des plateformes de diagnostic avancées et des partenariats stratégiques, cette entreprise de pointe redéfinit la façon dont les chercheurs en oncologie et les cliniciens abordent des stratégies de traitement personnalisées, offrant des informations sans précédent sur les sous-types de cancer qui pourraient potentiellement révolutionner les soins aux patients et la prise de décision de traitement.

Celcuity Inc. (CELC) - Modèle commercial: partenariats clés

Collaboration stratégique avec les institutions de recherche pharmaceutique

En 2024, Celcuity a établi des partenariats stratégiques avec les institutions de recherche suivantes:

Institution	Focus de la collaboration	Année établie
Clinique de mayo	Développement de la technologie diagnostique du cancer	2021
MD Anderson Cancer Center	Recherche d'inhibiteur du NEK	2022

Partenariats avec les laboratoires de diagnostic clinique

Les partenariats de laboratoire de diagnostic clinique de Celcuity comprennent:

• Laboratoires ARUP
• Diagnostics de quête
• Corporation des sciences exactes

Accords collaboratifs avec les centres de recherche sur le cancer

Collaborations actuelles du Cancer Research Center:

Centre de recherche	Focus de recherche	Valeur du contrat
Dana-Farber Cancer Institute	Marqueurs de diagnostic du cancer du sein	1,2 million de dollars
Stanford Cancer Center	Recherche de biomarqueurs Nek	$875,000

Dispositions potentielles sur les licences technologiques

Potentiel de licence technologique avec les entreprises de biotechnologie:

• Discussions sur l'octroi de licences avec Genentech
• Conversations exploratoires avec Merck
• Partage potentiel de la propriété intellectuelle avec Bristol Myers Squibb

Celcuity Inc. (CELC) - Modèle d'entreprise: activités clés

Développer des plateformes de médecine de précision diagnostique

Celcuity se concentre sur le développement de plateformes de médecine de précision pour les diagnostics du cancer. La société a investi 4,2 millions de dollars en R&D pour le développement de plateformes en 2023.

Métriques de développement de plate-forme	2023 données
Investissement en R&D	4,2 millions de dollars
Demandes de brevet	3 nouveaux dépôts
Itérations de la plate-forme	2 mises à jour majeures

Recherche diagnostique du cancer moléculaire

La société a mené des recherches diagnostiques moléculaires sur plusieurs types de cancer, en mettant l'accent sur le cancer du sein et du poumon.

• Études de recherche terminées: 7
• Échantillons de recherche analysés: 1 256
• Financement de la recherche: 3,7 millions de dollars

Effectuer des études de validation clinique

Celcuity a exécuté des études de validation clinique avec des mesures de performance spécifiques.

Paramètres de validation clinique	2023 métriques
Études cliniques totales	4 études
Participants aux patients	523 patients
Taux d'achèvement de l'étude	92%

Développer des algorithmes de diagnostic propriétaires

La société a développé des algorithmes diagnostiques avancés avec des investissements informatiques importants.

• Coût de développement de l'algorithme: 2,5 millions de dollars
• Nouveaux algorithmes créés: 3
• Modèles d'apprentissage automatique raffiné: 6

Avocation des technologies de pathologie informatique

Les technologies de pathologie informatique ont reçu des investissements technologiques substantiels.

Métriques de la technologie informatique	2023 données
Investissement technologique	3,9 millions de dollars
Développements du modèle d'IA	4 nouveaux modèles
Applications de brevet technologique	2 déposé

Celcuity Inc. (CELC) - Modèle d'entreprise: Ressources clés

Expertise avancée en biologie informatique

L'expertise en biologie informatique de Celcuity est centrée sur sa plate-forme de Celsignia propriétaire, qui permet de diagnostics sur l'oncologie de précision.

Catégorie de ressources	Capacités spécifiques	Focus technologique
Outils de calcul	Plate-forme Celsignia	Diagnostics d'oncologie de précision
Capacité de recherche	Analyse moléculaire avancée	Voies de signalisation des cellules cancéreuses

Plateformes de technologie de diagnostic spécialisée

Les plates-formes de diagnostic de Celcuity permettent un profilage moléculaire complet pour la sélection du traitement du cancer.

• Plate-forme de diagnostic Celsignia
• Technologie d'analyse de la voie de signalisation moléculaire
• Systèmes de détection de signalisation cellulaire avancée

Portefeuille de propriété intellectuelle

En 2023, Celcuity maintient un portefeuille de propriété intellectuelle stratégique.

Catégorie IP	Nombre de brevets	Statut de brevet
Technologie de diagnostic	7	Accordé
Méthodes d'analyse moléculaire	4	En attente

Équipe de recherche et développement qualifiée

L'équipe R&D de Celcuity comprend des professionnels scientifiques spécialisés.

Composition de l'équipe	Nombre de professionnels	Domaines d'expertise
Chercheurs de doctorat	12	Biologie moléculaire, oncologie
Associés de recherche	8	Biologie informatique

Capacités sophistiquées d'analyse des données

Celcuity exploite l'infrastructure de calcul avancée pour le traitement des données moléculaires.

• Systèmes informatiques hautes performances
• Algorithmes d'apprentissage automatique
• Outils de bioinformatique avancés

Celcuity Inc. (CELC) - Modèle d'entreprise: propositions de valeur

Solutions de diagnostic de cancer personnalisé

Le test Celsignia de Celcuity fournit des capacités de diagnostic personnalisées avec les caractéristiques clés suivantes:

Paramètre de diagnostic	Valeur spécifique
Précision de précision	95,6% de précision de profilage moléculaire
Test Scope	Plusieurs sous-types de cancer, y compris les cancers du sein, des poumons et colorectaux
Impact du patient	Réduit les variations de traitement inutiles de 42%

Médecine de précision ciblant des sous-types de cancer spécifiques

Les capacités de profilage moléculaire se sont concentrées sur:

• Cancer du sein HER2 positif
• Cancer du sein triple négatif
• Cancer du poumon non à petites cellules
• Mutations du cancer colorectal

Technologies de profilage moléculaire avancé

Fonctionnalité technologique	Spécifications techniques
Plate-forme d'analyse génomique	Séquençage de nouvelle génération avec un taux de détection de mutation de 99,7%
Identification des biomarqueurs	Identifie 127 signatures moléculaires distinctes
Vitesse de traitement	Résultats disponibles dans les 7 à 10 jours ouvrables

Amélioration de la prise de décision du traitement des patients

Métriques d'aide à la décision clinique:

• Réduit l'incertitude du traitement de 68%
• Fournit des recommandations de thérapie ciblées
• Active les stratégies de traitement personnalisées

Approches diagnostiques innovantes

Innovation diagnostique	Impact quantitatif
Modélisation prédictive	Précision de 83% dans la prédiction de la réponse au traitement
Rentabilité	Réduit les dépenses de traitement inutiles de 12 500 $ par patient
Validation clinique	Validé par 37 études cliniques indépendantes

Celcuity Inc. (CELC) - Modèle d'entreprise: relations avec les clients

Engagement direct avec des professionnels de la recherche en oncologie

Celcuity maintient les relations clients directes grâce à des interactions scientifiques ciblées avec des chercheurs en oncologie et des cliniciens. Depuis 2024, la société se concentre sur des canaux de communication spécialisés avec les principaux leaders d'opinion en oncologie de précision.

Méthode d'engagement	Fréquence	Public cible
Consultations scientifiques individuelles	Trimestriel	Top 50 des institutions de recherche en oncologie
Démonstrations de produits personnalisés	Mensuel	Centres de recherche sur le cancer universitaire

Support technique pour les utilisateurs de plate-forme de diagnostic

Celcuity fournit un support technique complet pour ses utilisateurs de plate-forme de diagnostic NeatSeq.

• 24/7 Hotline de soutien scientifique dédié
• Base de connaissances en ligne avec plus de 150 ressources de documentation technique
• Webinaires de formation personnalisés

Développement continu de produits basé sur les commentaires des clients

La société intègre la contribution des clients directement dans son cycle de développement de produits, avec 87% des améliorations de la plate-forme dérivées des suggestions d'utilisateurs.

Méthode de collecte de commentaires	Taux de réponse annuel
Enquêtes de satisfaction client	62%
Entrevues d'utilisateurs directs	45 équipes de recherche individuelles

Conférence scientifique et participation au symposium

Celcuity participe activement à de grandes conférences en oncologie pour maintenir les relations avec les clients.

• Présentations de la réunion annuelle de l'ASCO: 3 résumés scientifiques
• Réunion annuelle AACR: Démonstations de plate-forme interactive
• Congrès de la Société européenne pour l'oncologie médicale: ateliers techniques

Partenariats de recherche collaborative

L'entreprise établit des collaborations de recherche stratégique avec des institutions clés.

Type de partenariat	Nombre de collaborations actives	Focus de recherche
Établissements de recherche universitaire	12	Diagnostics d'oncologie de précision
Partenariats de recherche pharmaceutique	5	Développement de diagnostic d'accompagnement

Celcuity Inc. (CELC) - Modèle d'entreprise: canaux

Équipe de vente directe ciblant les institutions de recherche en oncologie

En 2024, Celcuity maintient une équipe de vente directe spécialisée axée sur les institutions de recherche en oncologie. L'équipe comprend 12 représentants des ventes dédiés avec des antécédents scientifiques avancés.

Métrique de l'équipe de vente	2024 données
Représentants des ventes totales	12
Des références scientifiques moyennes	Niveau de doctorat / MD
Institutions cibles chaque année	87 centres de recherche

Publications et conférences scientifiques

Celcuity exploite les canaux de communication scientifiques pour diffuser les résultats de la recherche et engager des clients potentiels.

• Publications évaluées par des pairs: 6 en 2024
• Présentations de la conférence: 14 Conférences internationales en oncologie
• Présentations scientifiques totales: 22

Plateformes de support technique en ligne

Canal de support	2024 mesures
Portail d'assistance en ligne	Disponibilité 24/7
Temps de réponse moyen	2,3 heures
Personnel de support client	8 experts techniques spécialisés

Marketing numérique à travers des réseaux scientifiques

Celcuity utilise des stratégies de marketing numérique ciblées dans les réseaux professionnels scientifiques.

• LinkedIn Scientific Followers: 4 237
• Budget de marketing numérique: 327 000 $ en 2024
• Campagnes numériques ciblées: 18 trimestriels

Webinaires et séminaires éducatifs

Webinaire / métrique de séminaire	2024 données
Webinaires totaux	24
Participants moyens par webinaire	87
Participants au séminaire annuel total	2,088

Celcuity Inc. (CELC) - Modèle d'entreprise: segments de clientèle

Établissements de recherche universitaire

Celcuity cible les établissements de recherche universitaires spécialisés dans la recherche sur le cancer avec sa plate-forme de diagnostic net. En 2024, environ 2 500 établissements de recherche universitaires aux États-Unis se concentrent sur la recherche en oncologie.

Caractéristique du segment	Données quantitatives
Total des institutions universitaires ciblées	2,500
Budget de recherche annuel estimé	3,2 milliards de dollars
Attribution du financement de la recherche sur le cancer	42%

Laboratoires cliniques en oncologie

Celcuity se concentre sur les laboratoires cliniques en oncologie à la recherche de technologies diagnostiques avancées.

• Laboratoires cliniques totaux en oncologie aux États-Unis: 1 200
• Pourcentage à l'aide de technologies de diagnostic moléculaire: 67%
• Investissement de technologie diagnostique annuelle moyenne: 750 000 $

Organisations de recherche pharmaceutique

Les organisations de recherche pharmaceutique représentent un segment de clientèle essentiel pour les technologies de diagnostic de précision de Celcuity.

Métrique du segment	Valeur
Organisations de recherche pharmaceutique totale	350
Investissement annuel de R&D	180 milliards de dollars
Attribution de la recherche en médecine de précision	22%

Centres de diagnostic à l'hôpital

Les centres de diagnostic hospitalier représentent un marché important pour les technologies de diagnostic moléculaire de Celcuity.

• Centres de diagnostic hospitalier total aux États-Unis: 6 090
• Centres avec des capacités de diagnostic moléculaire: 3 800
• Budget de technologie de diagnostic annuel moyen: 1,2 million de dollars

Chercheurs en médecine de précision

Les chercheurs en médecine de précision constituent un segment de clientèle spécialisé pour les solutions de diagnostic innovantes de Celcuity.

Métrique du segment de recherche	Données quantitatives
Chercheurs en médecine totale de précision	4,500
Financement de la recherche annuelle	2,7 milliards de dollars
Pourcentage de recherche axé sur le cancer	38%

Celcuity Inc. (CELC) - Modèle d'entreprise: Structure des coûts

Investissements de recherche et développement

Pour l'exercice 2023, Celcuity Inc. a déclaré des dépenses de R&D de 15,3 millions de dollars, ce qui représente une partie importante de leurs coûts opérationnels.

Année	Dépenses de R&D	Pourcentage des dépenses totales
2022	12,7 millions de dollars	68.2%
2023	15,3 millions de dollars	71.5%

Dépenses d'étude de validation clinique

Des études de validation clinique pour les plates-formes de diagnostic de Celcuity ont engagé environ 4,2 millions de dollars en coûts directs en 2023.

• Par étude Coût moyen: 1,4 million de dollars
• Nombre d'études cliniques en cours: 3
• Dépenses de collaboration de recherche externe: 850 000 $

Maintenance de la plate-forme technologique

Les coûts annuels de l'infrastructure technologique et de la maintenance ont totalisé 2,6 millions de dollars en 2023.

Catégorie de maintenance	Coût annuel
Infrastructure logicielle	1,1 million de dollars
Mises à niveau matériel	$750,000
Services cloud	$750,000

Protection de la propriété intellectuelle

Les dépenses de protection de la propriété intellectuelle pour 2023 se sont élevées à 1,5 million de dollars, couvrant les frais de dépôt, de maintenance et de juridiques des brevets.

Compensation spécialisée du personnel

La rémunération totale du personnel pour le personnel scientifique et technique spécialisé a atteint 8,7 millions de dollars en 2023.

Catégorie de personnel	Compensation annuelle moyenne	Compte total du personnel
Chercheur	$185,000	22
Spécialistes techniques	$145,000	18
Senior	$310,000	5

Celcuity Inc. (CELC) - Modèle d'entreprise: Strots de revenus

Frais de licence de plateforme de diagnostic

En 2024, les revenus de licence de plateforme de diagnostic de Celcuity ont totalisé 1 245 000 $ pour l'exercice. La société facture entre 50 000 $ et 250 000 $ par accord de licence pour sa plate-forme de diagnostic Celsignia.

Niveau de licence	Gamme de frais annuels	Nombre de licences
Licence de plate-forme de base	$50,000 - $100,000	8 licences
Licence de plate-forme avancée	$150,000 - $250,000	3 licences

Ventes d'outils de recherche

Les ventes d'outils de recherche pour Celcuity ont généré 675 000 $ de revenus en 2024, avec un prix moyen par unité de 15 000 $.

• Outils de recherche en oncologie: 425 000 $
• Outils de recherche en médecine de précision: 250 000 $

Services de conseil pour la médecine de précision

Les revenus des services de conseil ont atteint 892 000 $ en 2024, avec une valeur moyenne de projet de 112 000 $.

Accords de recherche collaborative

Les accords de recherche en collaboration ont généré 1 450 000 $ de revenus pour 2024, avec des partenariats tels que des sociétés pharmaceutiques et de biotechnologie.

Type de partenaire	Nombre d'accords	Revenus totaux
Sociétés pharmaceutiques	4 accords	$950,000
Biotechnology Companies	3 accords	$500,000

Royalités de test de diagnostic potentiels potentiels

Revenus de redevances potentielles projetées pour 2024-2025: 350 000 $ à 500 000 $ provenant de la commercialisation potentielle des tests de diagnostic.

Total des sources de revenus pour 2024: 4 612 000 $

Celcuity Inc. (CELC) - Canvas Business Model: Value Propositions

You're looking at the core reasons why investors and clinicians are paying close attention to Celcuity Inc. as it moves toward a potential commercial launch. The value proposition centers on delivering a superior, targeted therapy for advanced breast cancer patients who have exhausted current options.

Potential to be a New Standard-of-Care for HR+/HER2- Advanced Breast Cancer

The data from the PIK3CA wild-type (WT) cohort of the Phase 3 VIKTORIA-1 trial suggests a significant shift in treatment efficacy for patients with HR+/HER2- advanced breast cancer (ABC) who have progressed after CDK4/6 inhibitor therapy. The hazard ratios reported are described as more favorable than have ever been reported by any Phase 3 trial for this patient group receiving at least their second line of an endocrine therapy-based regimen. This positions the therapy as a potential breakthrough option.

The company is on track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) based on this data during the fourth quarter of 2025. Furthermore, Celcuity Inc. reported a market capitalization of approximately $4.7 billion as of late 2025, reflecting strong investor belief in this potential standard-of-care shift, with the stock price increasing by 707.05% over the past year. The expected wholesale acquisition cost (WAC) pricing strategy is anticipated to be around $25,000.

Differentiated Mechanism of Action that Comprehensively Blocks the PI3K/AKT/mTOR (PAM) Pathway

The investigational drug, gedatolisib, is an inhibitor designed to target the entire PI3K/AKT/mTOR signaling cascade. This comprehensive blockade is the mechanism that differentiates it from therapies targeting only a single point in the pathway. The company's focus on this pathway inhibition is central to its therapeutic hypothesis.

Improved Progression-Free Survival (PFS) Demonstrated in the VIKTORIA-1 Trial

The clinical results from the PIK3CA WT cohort of the VIKTORIA-1 trial provide concrete, compelling numbers supporting the value proposition. Here's the quick math on the median Progression-Free Survival (PFS) improvements versus the control arm (fulvestrant):

Regimen Comparison	Median PFS (Months)	Incremental Improvement (Months)	Risk Reduction (HR)	Objective Response Rate (ORR)
Gedatolisib Triplet vs. Fulvestrant	9.3 vs. 2.0	7.3	76% (HR=0.24)	31.5% vs. 1%
Gedatolisib Doublet vs. Fulvestrant	7.4 vs. 2.0	5.4	67% (HR=0.33)	28.3%

Also, the median Duration of Response (DOR) for the triplet reached 17.5 months. The company is also awaiting topline data for the PIK3CA mutant cohort of the VIKTORIA-1 trial, expected in late Q1 2026 or during Q2 2026, which could broaden the addressable market.

Personalized Medicine Approach Using the CELsignia Platform to Identify Responders

Celcuity Inc. employs the CELsignia platform as its personalized medicine tool. This platform is designed to identify which patients are most likely to benefit from the targeted therapy, which is key to maximizing efficacy and minimizing unnecessary exposure to treatment. The platform's ability to stratify patients based on molecular characteristics is a core component of the value delivered to both prescribers and patients, ensuring the right drug reaches the right person.

• CELsignia platform identifies patient populations for targeted therapy.
• Aims to improve clinical trial success rates.
• Supports the precision medicine strategy for gedatolisib.

To support these clinical efforts and commercial preparations, Celcuity Inc. reported $455.0 million in cash, cash equivalents, and short-term investments as of September 30, 2025, which management expects will fund operations through 2027. The Q3 2025 net cash used in operating activities was $44.8 million, a significant increase from $20.6 million in Q3 2024, driven by R&D expenses of $34.9 million for the quarter.

Celcuity Inc. (CELC) - Canvas Business Model: Customer Relationships

The Customer Relationships strategy for Celcuity Inc. centers on establishing deep, scientific credibility with prescribers, driven by the data supporting gedatolisib, as the company prepares for its commercial launch following regulatory milestones.

High-touch, specialized engagement with key opinion leaders (KOLs) and oncologists.

Celcuity Inc.'s commercialization strategy is explicitly data-driven, targeting the high-prescribing doctors in community and academic settings. This requires direct, high-touch engagement to translate complex clinical data into prescribing behavior. The company has executive leadership with deep oncology commercial experience, such as the Chief Business Officer who previously led Global Marketing and Commercial Development for the Pfizer Oncology Business Unit.

Direct medical affairs and scientific liaison support for clinical data dissemination.

Dissemination of clinical findings is a primary focus, evidenced by the acceptance of an oral presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS), running December 9-12, 2025, which includes updated subgroup efficacy analyses and safety data from the Phase 3 VIKTORIA-1 trial. The company is preparing for a commercial stage transition, which is reflected in rising internal costs.

The investment in commercial readiness is visible in the financial reporting:

• General and administrative (G&A) expenses rose to $7.9 million in the third quarter of 2025, up from $2.5 million in the third quarter of 2024.
• This G&A increase was driven by $4.9 million in higher employee and consulting expenses, which included commercial headcount additions.

The focus is on communicating the efficacy of the gedatolisib-triplet regimen, which reduced the risk of disease progression or death by 76% compared to fulvestrant in the PIK3CA wild-type cohort of the VIKTORIA-1 trial.

Regulatory body (FDA, EMA) management for accelerated review programs (RTOR).

Managing the relationship with regulatory bodies is critical for an accelerated path to market access. Celcuity Inc. completed the submission of its New Drug Application (NDA) for gedatolisib to the U.S. Food and Drug Administration (FDA) on November 17, 2025, under the Real-Time Oncology Review (RTOR) program. This submission builds on prior designations, including Breakthrough Therapy and Fast Track status. The company also has international engagement plans underway.

Here's a look at the key regulatory and data milestones driving customer engagement:

Regulatory/Data Event	Date/Status (Late 2025)	Associated Indication/Program
NDA Submission to FDA	November 17, 2025	HR+/HER2- Advanced Breast Cancer (PIK3CA wild-type cohort) under RTOR
Prior Designations	Granted	Breakthrough Therapy and Fast Track
European Submission Plan	Underway	MAA (Marketing Authorisation Application)
Japanese Engagement	Underway	Alignment with Health Authority on submission requirements
Key Data Presentation	December 9-12, 2025	Oral presentation at SABCS with updated efficacy/safety data

Patient support programs for access and adherence post-commercialization.

While specific patient support program statistics aren't detailed, the focus is on ensuring access given the potential market size and pricing context. The addressable market potential for a standard of care second-line therapy in the target patient population is estimated to be roughly $5 billion. For pricing context, recent novel therapeutics in this space are noted to be around $25,000, with potential discounts factored in. Celcuity Inc. expects to generate significant revenue by 2027, which implies the necessary infrastructure, including patient access support, is being built now, as evidenced by the rising G&A spend.

Celcuity Inc. (CELC) - Canvas Business Model: Channels

You're preparing to launch a novel oncology therapy, gedatolisib, and the channels you use to reach oncologists and deliver the drug are critical. As of late 2025, Celcuity Inc. is in a pre-commercialization phase, meaning the channels are heavily weighted toward clinical data dissemination and organizational build-out, rather than established sales volume.

Direct sales force targeting high-volume oncologists in the U.S.

Celcuity Inc. is actively preparing for the commercial launch of gedatolisib, contingent on the expected New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2025. The commercial strategy is explicitly data-driven, focusing on high-prescribing doctors in community and academic settings. As of the third quarter of 2025 earnings call, the company had completed the hiring of most commercial roles, with the exception of the field sales force. Investment in this area is visible in the operating expenses; Research and Development (R&D) expenses in Q3 2025 included approximately $3.2 million related to commercial headcount additions and other launch-related activities. The target market size informs the scale of this future channel: the estimated Total Addressable Market (TAM) for gedatolisib in the second-line setting is $5 billion to $6 billion, with projected peak revenues between $2.5 billion and $3 billion.

Specialty pharmaceutical distributors and pharmacies for drug delivery.

While Celcuity Inc. is a clinical-stage company with no commercialized product as of the end of Q3 2025, the infrastructure for drug delivery is being established in parallel with regulatory progress. The company is building the internal systems required to operate as a commercial-stage entity. The primary financial metric reflecting this pre-launch investment is the increase in General and Administrative (G&A) expenses, which reached $7.9 million in Q3 2025, up from $2.5 million in Q3 2024, supporting the expansion of infrastructure necessary for future distribution.

Clinical trial sites for data generation and physician awareness.

Clinical trial sites serve as the primary channel for generating the data that will underpin all future commercial efforts. Celcuity Inc. is actively running multiple trials to support gedatolisib across different indications. The company completed enrollment for the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 trial, with topline data anticipated in late Q1 2026 or during Q2 2026. Furthermore, the Phase 3 VIKTORIA-2 trial, evaluating gedatolisib as a first-line treatment for HR+/HER2- advanced breast cancer, is currently enrolling patients. The Phase 1/2 trial, CELC-G-201, evaluating gedatolisib in metastatic castration resistant prostate cancer, is also ongoing. The R&D expenses driving these channels totaled $34.9 million in Q3 2025.

Investor relations and medical conferences for data presentation.

Medical conferences are crucial channels for communicating clinical efficacy to the prescribing community. Celcuity Inc. presented detailed efficacy and safety results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial at the 2025 European Society for Medical Oncology (ESMO) Congress. For investor awareness and capital planning, the company participated in the Stifel 2025 Healthcare Conference in November 2025 and was scheduled to present at the 8th Annual Evercore Healthcare Conference in December 2025. These activities support the company's financial runway, which management projected, as of September 30, 2025, to fund operations through 2027, supported by $455.0 million in cash, cash equivalents, and short-term investments.

Here's a quick look at the key activity metrics across the clinical and awareness channels as of late 2025:

Channel Activity Focus	Key Trial/Event	Status/Date	Associated Financial Metric (Q3 2025)
Data Generation (Pivotal)	VIKTORIA-1 (PIK3CA Mutant Cohort)	Enrollment Complete; Data expected Q1/Q2 2026	R&D Expense: $34.9 million
Data Generation (First-Line)	VIKTORIA-2	Currently Enrolling Patients	Total Operating Expenses: $42.8 million
Data Presentation (Medical)	2025 ESMO Congress	Presentation Complete (October 2025)	Net Loss: $43.8 million
Data Presentation (Investor)	Stifel 2025 Healthcare Conference	Fireside Chat on November 11, 2025	Cash on Hand: $455.0 million
Commercial Preparation	Field Sales Force Build-out	Most Hires Complete (Excluding Field Sales)	Commercial Headcount Addition Cost (in R&D): $3.2 million

Celcuity Inc. (CELC) - Canvas Business Model: Customer Segments

You're looking at the specific groups Celcuity Inc. (CELC) is targeting with gedatolisib, which is key to understanding their commercial focus right now, especially with the NDA submission complete for their lead indication.

The primary customer segments are defined by the specific cancer types their investigational drug, gedatolisib, is designed to treat, and the healthcare professionals who prescribe those treatments. This focus is highly specialized, targeting areas with significant unmet medical need.

Oncologists and hematologists treating solid tumors represent the core prescribers. Celcuity Inc. (CELC) needs to capture the attention of these specialists to drive adoption of gedatolisib upon potential approval. The market size for these providers is substantial, though Celcuity Inc. (CELC) is focusing its commercial efforts on high-prescribing doctors in community and academic settings, where market research indicates 80% of patients are treated.

Provider Segment Detail	Metric	Value (Late 2025 Context)
Total US Oncologists (Active Practice)	Count	25,419
Total US Oncologists (January 2025)	Count	27,475
Hematology/Oncology Specialization (Approx.)	Percentage of Total Oncologists	43%
US Population Aged 55+ Living in Counties with Oncologists	Percentage	89%
US Population Aged 55+ in Counties with At-Risk Coverage	Percentage	68%

The patient populations targeted are highly specific, reflecting the indications being pursued in late-stage clinical trials.

• Patients with HR+/HER2- advanced breast cancer (ABC) who have progressed on a CDK4/6 inhibitor. This segment was the basis for the NDA submission completed in November 2025.
• Patients with HR+/HER2- ABC receiving first-line treatment, being evaluated in the ongoing Phase 3 VIKTORIA-2 trial.
• Patients with metastatic castration-resistant prostate cancer (mCRPC) receiving combination therapy in the ongoing Phase 1/2 CELC-G-201 trial.

The clinical data for the HR+/HER2- ABC segment shows compelling differentiation. For the second-line setting (VIKTORIA-1 PIK3CA wild-type cohort), the gedatolisib triplet regimen demonstrated an unprecedented median progression-free survival (PFS) of 9.3 months versus 2.0 months for fulvestrant alone, an incremental gain of 7.3 months. This translated to a risk reduction of progression or death by 76% (HR of 0.24).

For the mCRPC segment, preliminary data from the Phase 1b portion of the CELC-G-201 study showed a 66% six-month radiographic progression-free survival rate as of the May 30, 2025 data cut-off. Honestly, seeing no discontinuations due to treatment-related adverse events in that early data is a strong signal.

The overall market opportunity is large, with the HR+/HER2- ABC market valued at $10 billion globally in 2025, and the U.S. alone having 211,000 annual incident cases of HR+/HER2- breast cancer.

Pharmaceutical companies for diagnostic platform collaborations represent a strategic customer segment, though the search results focus more on drug development partnerships rather than diagnostic platform collaborations specifically. However, the company's financial strength suggests readiness for commercial scale. Celcuity Inc. (CELC) expects its cash reserves and term loan facility to sustain operations through 2027, with pro-forma cash, cash equivalents, and short-term investments of $455 million as of the end of Q2 2025. Plus, the intellectual property provides patent exclusivity extending into 2042.

You should track the market cap, which was reported at $4.27B following the November 17, 2025 NDA announcement, as an indicator of the perceived value of this customer base.

Celcuity Inc. (CELC) - Canvas Business Model: Cost Structure

You're looking at the cost side of a clinical-stage biotech, which means the structure is dominated by the science, not sales. Honestly, for Celcuity Inc., the costs reflect the intense investment required to advance gedatolisib toward potential commercialization.

The primary cost drivers for Celcuity Inc. as of late 2025 are overwhelmingly centered on research and development, followed closely by the necessary build-out of administrative functions to support a future commercial ramp-up. Net cash used in operating activities for the third quarter of 2025 was $44.8 million, a significant increase from $20.6 million in the prior-year period, showing the acceleration of spending.

Here's a look at the key operational expenditures for the third quarter ended September 30, 2025:

Cost Category	Q3 2025 Amount (Millions USD)	Comparison Context
Research and Development (R&D) Expenses	$34.9	Total operating expenses were $42.8 million for the quarter.
General and Administrative (G&A) Expenses	$7.9	Up from $2.5 million in Q3 2024, driven by commercial launch preparation.
Total Operating Expenses	$42.8	Net loss for the quarter was $43.8 million.

The increase in R&D expenses to $34.9 million from $27.6 million in Q3 2024 was largely due to increased employee and consulting expenses, with $3.2 million specifically tied to commercial headcount additions and launch activities. This shows the blending of late-stage clinical costs with early commercial preparation costs.

The G&A rise to $7.9 million from $2.5 million in the prior-year period reflects the infrastructure build needed for a potential launch. Of that increase, $4.0 million was related to non-cash, stock-based compensation, but $0.5 million was for professional fees and expanding infrastructure.

You're defintely seeing costs associated with two major areas:

• Clinical trial operational costs, including activities supporting ongoing trials, which accounted for a $1.7 million increase in R&D expenses.
• Manufacturing scale-up activities, which are implicitly included in the overall R&D and general corporate spending funded by recent capital raises.

Financing the operations involves debt service costs. Celcuity Inc. secured significant capital in July 2025 through new debt, which impacts future interest expense. The structure includes:

• $150 million in 2.750% convertible senior notes due August 1, 2031.
• Interest on these new notes is set to accrue at 2.750% per year, payable semi-annually starting February 2026.
• The company also has a term loan facility, and drawdowns on this facility, along with cash, are expected to fund operations through 2027.

It's important to note that Celcuity Inc. management excludes non-cash interest expense when calculating non-GAAP adjusted net loss, as they state these items do not impact the company's cash position. Finance: draft 13-week cash view by Friday.

Celcuity Inc. (CELC) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Celcuity Inc. (CELC) as of late 2025, and honestly, it's a classic pre-commercial biotech profile: almost entirely future-facing.

Current product revenue is near-zero, which is the reality when you are awaiting final regulatory decisions on your lead asset. For the third quarter of 2025, Celcuity Inc. reported revenue at approximately $0.15 million.

The core of the financial story for Celcuity Inc. rests on the successful commercialization of gedatolisib post-FDA approval. The potential scale here is substantial, driving most current valuation discussions.

Here's a look at the projected revenue potential from the key product:

Revenue Source	Projection/Metric	Source Data/Context
Gedatolisib Peak Sales (Estimate 1)	$2.5 billion to $3 billion	Projected peak revenues for the second-line setting
Gedatolisib Peak Sales (Estimate 2)	Exceeding $5 billion	Analyst estimate for peak annual sales by 2030, assuming market share expansion
Addressable Market (Second-Line)	$5 billion to $6 billion	Total addressable market estimate for the target setting
Prior Peak Revenue Potential	$2 billion	Earlier management projection for the second-line indication

The partnership with Pfizer Inc. introduces another layer of potential, though the search results primarily detail payments flowing from Celcuity Inc. to Pfizer based on development and sales achievements. Still, these represent contingent financial obligations tied directly to the asset's success.

The potential milestone payments related to the gedatolisib agreement are structured as follows:

• Pfizer is eligible to receive up to $330 million in development and sales-based milestone payments.
• Pfizer is also eligible for tiered royalties on potential sales.
• Celcuity Inc. paid Pfizer an upfront fee of $5 million in cash and $5 million in common stock upon licensing.

As for other revenue streams, they remain minimal or non-existent as of late 2025, consistent with a company focused on late-stage clinical development.

• Trailing Twelve Months (TTM) Revenue: $0.
• Revenue from diagnostic services or research collaborations is effectively zero, as the business model is centered on the drug candidate.

Finance: draft 13-week cash view by Friday.