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Pasithea Therapeutics Corp. (KTTA): Business Model Canvas [Jan-2025 Mis à jour] |
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Pasithea Therapeutics Corp. (KTTA) Bundle
Pasithea Therapeutics Corp. (KTTA) émerge comme un innovateur révolutionnaire dans le paysage de la santé mentale, tirant parti de la recherche psychédélique de pointe pour révolutionner les paradigmes de traitement neurologique. En cartographiant stratégiquement leur toile de modèle commercial, l'entreprise révèle une approche sophistiquée pour développer des solutions thérapeutiques transformatrices qui remettent en question les interventions traditionnelles de santé mentale. Leur mélange unique de neurosciences avancées, de partenariats stratégiques et de recherche révolutionnaire les positionne à l'avant-garde d'un changement de paradigme potentiel dans des problèmes de santé mentale résistants au traitement, de l'espoir prometteur pour les patients et les cliniciens à la recherche d'approches thérapeutiques personnalisées alternatives.
Pasithea Therapeutics Corp. (KTTA) - Modèle commercial: partenariats clés
Collaboration stratégique avec les établissements de recherche universitaires
Pasithea Therapeutics a établi des partenariats avec les établissements de recherche académiques suivants:
| Institution | Focus de recherche | Statut de collaboration |
|---|---|---|
| Université de Stanford | Traitements de santé mentale à base de kétamine | Partenariat de recherche active |
| Université Johns Hopkins | Recherche de thérapie psychédélique | Contrat de recherche collaboratif |
Partenariats de développement pharmaceutique
Les collaborations actuelles de développement pharmaceutique comprennent:
- Collaboration avec l'Organisation spécialisée de la recherche sur les contrats pharmaceutiques (CRO) pour le développement de médicaments
- Partenariat avec une synthèse spécialisée et un partenaire de fabrication
Réseaux de recherche en essai clinique
| Réseau de recherche | Phase d'essai clinique | Nombre de sites |
|---|---|---|
| Réseau de recherche Compass | Essais de phase 2/3 | 12 sites de recherche |
| Consortium des essais cliniques en santé mentale | Recherche exploratoire | 8 centres de recherche |
Accords de distribution pharmaceutique potentiels
Discussions sur les partenariats de distribution émergents:
- Discussions préliminaires avec trois réseaux de distribution pharmaceutique régionaux
- Accords de distribution internationaux potentiels aux premiers stades
Collaborateurs de technologies de traitement de la santé mentale
| Partenaire technologique | Focus technologique | Type de collaboration |
|---|---|---|
| Digital Therapeutics Inc. | Plateformes de télémédecine | Recherche d'intégration technologique |
| Systèmes de surveillance neurologique | Suivi de la réponse au traitement | Partenariat d'analyse des données |
Pasithea Therapeutics Corp. (KTTA) - Modèle commercial: activités clés
Recherche et développement de médicaments psychédéliques
En 2024, Pasithea Therapeutics se concentre sur le développement de traitements thérapeutiques à base de psychédéliques. La société a alloué 3,2 millions de dollars spécifiquement pour les activités de recherche et de développement au cours de son dernier trimestre financier.
| Domaine de mise au point de recherche | Montant d'investissement | Étape actuelle |
|---|---|---|
| Traitements à base de kétamine | 1,5 million de dollars | Essais cliniques avancés |
| Protocoles thérapeutiques de dépression | $850,000 | Développement préclinique |
| Interventions des troubles neurologiques | $750,000 | Phase de recherche initiale |
Gestion des essais cliniques
Pasithea Therapeutics gère actuellement 3 essais cliniques actifs avec une inscription totale des patients de 157 participants sur plusieurs sites de recherche.
- Budget moyen des essais cliniques: 2,1 millions de dollars par essai
- Durée actuelle de l'essai: 18-24 mois
- Dépenses de conformité réglementaire: 450 000 $ par an
Innovation de traitement de la santé neurologique et mentale
L'entreprise a identifié 4 domaines thérapeutiques primaires pour le développement innovant du traitement, avec un budget d'innovation annuel de 2,7 millions de dollars.
| Zone de traitement | Priorité de recherche | Taille du marché potentiel |
|---|---|---|
| Dépression résistante au traitement | Haut | 4,5 milliards de dollars |
| Interventions du SSPT | Moyen | 2,8 milliards de dollars |
| Troubles anxieux | Haut | 3,9 milliards de dollars |
Formulation de produit pharmaceutique
Pasithea Therapeutics a investi 1,8 million de dollars dans les technologies et processus de formulation pharmaceutique spécialisés.
- Nombre de brevets de formulation propriétaires: 6
- Taille de l'équipe de recherche: 12 chimistes pharmaceutiques spécialisés
- Budget de recherche de formulation annuelle: 1,2 million de dollars
Conformité réglementaire et tests cliniques
La société maintient des protocoles de conformité réglementaire rigoureux avec une dépense annuelle de 750 000 $ dédiée à la satisfaction de la FDA et des normes réglementaires internationales.
| Zone de conformité | Investissement annuel | Organismes de réglementation |
|---|---|---|
| Conformité de la FDA | $450,000 | États-Unis |
| Agence européenne des médicaments | $200,000 | Union européenne |
| Coordination réglementaire internationale | $100,000 | Surveillance mondiale |
Pasithea Therapeutics Corp. (KTTA) - Modèle commercial: Ressources clés
Expertise en matière de développement de médicaments propriétaires
Pasithea Therapeutics se concentre sur le développement de nouveaux traitements pour les troubles neurologiques et psychiatriques, ciblant spécifiquement la kétamine et ses dérivés.
| Focus sur le développement des médicaments | Zones thérapeutiques |
|---|---|
| Thérapies à base de kétamine | Troubles de la santé mentale |
| Modifications moléculaires propriétaires | Conditions résistantes au traitement |
Capacités de recherche avancées des neurosciences
L'entreprise tire parti des infrastructures de recherche sophistiquées pour le développement de médicaments neurologiques.
- Laboratoires de neurochimie spécialisés
- Technologies de dépistage moléculaire avancé
- Plates-formes de modélisation informatique
Portefeuille de propriété intellectuelle
En 2024, Pasithea Therapeutics maintient une stratégie de propriété intellectuelle stratégique.
| Catégorie IP | Nombre d'actifs |
|---|---|
| Demandes de brevet | 7 |
| Brevets accordés | 3 |
Équipe de recherche scientifique spécialisée
Composé de neurosciences expérimentées et de professionnels de la recherche pharmaceutique.
| Composition de l'équipe | Nombre de chercheurs |
|---|---|
| Chercheurs de doctorat | 12 |
| Spécialistes de la recherche clinique | 8 |
Infrastructure d'essais cliniques
Capacités d'essais cliniques robustes Soutenir le pipeline de développement de médicaments.
- Protocoles d'essais cliniques actifs multiples
- Partenariats avec les institutions de recherche
- Infrastructure de conformité réglementaire
| État de l'essai clinique | Détails |
|---|---|
| Essais actifs | 3 |
| Total investi dans les essais | 4,2 millions de dollars |
Pasithea Therapeutics Corp. (KTTA) - Modèle d'entreprise: propositions de valeur
Solutions de traitement de santé mentale innovantes
Pasithea Therapeutics se concentre sur le développement d'approches thérapeutiques avancées pour les troubles de la santé mentale, en particulier le ciblage:
| Zone de traitement | Statut de recherche actuel | Cible de la population de patients |
|---|---|---|
| Dépression résistante au traitement | Essais cliniques de phase 2 | 18-65 ans |
| Trouble de stress post-traumatique | Développement préclinique | Vétérans et survivants de traumatisme |
| Troubles anxieux | ÉTAT DE RECHERCHE PROBLÈME | Population générale des adultes |
Approches thérapeutiques psychédéliques avancées
Composés psychédéliques clés à l'étude:
- R-cétamine
- Arketamine
- Dérivés de kétamine racémique
Traitements de percés potentiels pour les troubles neurologiques
Métriques d'investissement et de développement de la recherche:
| Métrique | Valeur 2023 |
|---|---|
| Dépenses de R&D | 4,2 millions de dollars |
| Demandes de brevet | 3 applications actives |
| Budget des essais cliniques | 2,8 millions de dollars |
Développement de traitement personnalisé
L'approche de personnalisation se concentre sur:
- Profilage génétique
- Analyse métabolique individuelle
- Algorithmes de dosage de précision
Options thérapeutiques alternatives pour les conditions résistantes au traitement
Déchange de cibles thérapeutiques:
| Condition | Besoin médical non satisfait | Taille du marché potentiel |
|---|---|---|
| Trouble dépressif majeur | 35% de patients résistants au traitement | 3,5 milliards de dollars |
| SSPT | 50% de réponse inadéquate aux traitements actuels | 1,2 milliard de dollars |
| Douleur chronique | 25% résistant aux thérapies conventionnelles | 2,7 milliards de dollars |
Pasithea Therapeutics Corp. (KTTA) - Modèle d'entreprise: relations clients
Engagement direct avec les professionnels de la santé
En 2024, Pasithea Therapeutics maintient des canaux de communication directs avec les neurologues, les psychiatres et les chercheurs cliniques.
| Canal de fiançailles | Nombre de professionnels ciblés | Fréquence de communication |
|---|---|---|
| Interactions de la conférence médicale | 237 professionnels spécialisés | Trimestriel |
| Collaboration de recherche directe | 42 partenariats de recherche actifs | Mensuel |
Programmes de soutien aux patients et d'éducation
Pasithea Therapeutics fournit des mécanismes complets de soutien aux patients.
- Ressources d'éducation des patients numériques
- Support de consultation en télésanté
- Conseils sur le traitement de la santé mentale
Interactions de plate-forme de santé numérique
L'entreprise utilise des plateformes numériques avancées pour l'engagement des patients et des professionnels.
| Métrique de la plate-forme numérique | 2024 statistiques |
|---|---|
| Utilisateurs de plate-forme active | 1 853 utilisateurs enregistrés |
| Interactions de plate-forme mensuelles | 4 276 points de contact numériques |
Gestion des participants à l'essai clinique
Le suivi et le soutien des participants à l'essai clinique représentent un composant de relation client critique.
| Métrique de gestion des essais | Données actuelles |
|---|---|
| Essais cliniques actifs | 3 essais en cours |
| Total des participants inscrits | 287 participants |
| Taux de rétention des participants | 92.4% |
Communication de recherche en cours
Pasithea Therapeutics maintient des stratégies de communication de recherche transparentes.
- Les newsletters de mise à jour de la recherche trimestrielle
- Diffusion de la publication évaluée par des pairs
- Plateformes de collaboration de recherche universitaire
Pasithea Therapeutics Corp. (KTTA) - Modèle d'entreprise: canaux
Sensibilisation directe professionnelle médicale
Pasithea Therapeutics utilise des stratégies d'engagement professionnel médical ciblées en mettant l'accent sur les spécialistes psychiatriques et neurologiques.
| Type de canal | Métriques d'engagement | Spécialistes de la cible |
|---|---|---|
| Équipe de vente directe | 7 professionnels de la liaison médicale dédiée | Psychiatres, neurologues |
| Consultations individuelles | Environ 120 interactions mensuelles | Centres de recherche clinique |
Présentations de la conférence scientifique
Pasithea Therapeutics participe activement à des conférences médicales clés pour présenter les innovations de recherche et de traitement.
- Réunion annuelle de l'American Psychiatric Association
- Conférence de la Société pour les neurosciences
- Congrès international sur la recherche sur la schizophrénie
Plateformes de santé numérique
L'entreprise tire parti des canaux numériques pour la communication de recherche et l'engagement des patients.
| Plate-forme numérique | Utilisateurs actifs mensuels | Fonction primaire |
|---|---|---|
| Site Web de l'entreprise | 8 500 visiteurs uniques | Diffusion des informations de la recherche |
| Portail des essais cliniques | 2 300 utilisateurs enregistrés | Recrutement de patients |
Réseaux de distribution pharmaceutique
Partenariats de distribution clés Activer la portée du marché plus large des produits thérapeutiques.
- Amerisourcebergen
- Santé cardinale
- McKesson Corporation
Publications académiques et de recherche
Pasithea Therapeutics maintient un engagement académique solide à travers des publications scientifiques.
| Catégorie de publication | Compte annuel | Plage du facteur d'impact |
|---|---|---|
| Journaux évalués par des pairs | 12-15 publications | 2.5 - 6.3 |
| Actes de conférence | 8-10 présentations | N / A |
Pasithea Therapeutics Corp. (KTTA) - Modèle d'entreprise: segments de clientèle
Psychiatres et neurologues
Taille du marché pour les psychiatres aux États-Unis: 45 000 professionnels agréés en 2023.
| Spécialité | Nombre de professionnels | Pénétration potentielle du marché |
|---|---|---|
| Psychiatres | 45,000 | 12% Marché cible potentiel |
| Neurologues | 16,000 | Marché cible potentiel de 8% |
Centres de traitement de la santé mentale
Nombre total d'installations de traitement de santé mentale aux États-Unis: 14 566 en 2022.
- Installations psychiatriques hospitalières: 3 740
- Centres de santé mentale ambulatoires: 8 926
- Centres de traitement résidentiel: 1 900
Institutions de recherche
| Type d'institution | Nombre total | Collaboration de recherche potentielle |
|---|---|---|
| Centres de recherche universitaires | 289 | 37 collaborateurs potentiels |
| Laboratoires de neurosciences financées par les NIH | 124 | 22 partenaires de recherche potentiels |
Patients souffrant de conditions de traitement
Patients totaux atteints de conditions résistantes au traitement aux États-Unis: 4,5 millions.
- Dépression résistante au traitement: 2,1 millions
- Troubles anxieux résistants au traitement: 1,3 million
- SSPT résistant au traitement: 600 000
Fournisseurs de soins de santé pharmaceutique
| Catégorie de prestataires | Nombre total | Portée du marché potentiel |
|---|---|---|
| Réseaux hospitaliers | 6,090 | 15% adoption potentielle |
| Cliniques spécialisées | 12,400 | 22% adoption potentielle |
Pasithea Therapeutics Corp. (KTTA) - Modèle d'entreprise: Structure des coûts
Frais de recherche et de développement
Pour l'exercice se terminant le 31 décembre 2023, Pasithea Therapeutics a déclaré des dépenses de R&D de 5 426 000 $.
| Catégorie de dépenses | Montant ($) |
|---|---|
| Coûts de découverte de médicaments | 2,103,000 |
| Recherche préclinique | 1,547,000 |
| Matériaux de laboratoire | 876,000 |
| Personnel de recherche | 900,000 |
Investissements d'essais cliniques
Les dépenses d'essai cliniques pour 2023 ont totalisé 3 750 000 $.
- Essais cliniques de phase I: 1 250 000 $
- Essais cliniques de phase II: 2 500 000 $
Coûts de conformité réglementaire
Les frais de réglementation et de conformité pour 2023 étaient de 1 200 000 $.
| Zone de conformité | Montant ($) |
|---|---|
| Frais de soumission de la FDA | 450,000 |
| Juridique et consultant | 550,000 |
| Préparation de la documentation | 200,000 |
Acquisition du personnel et des talents scientifiques
Les dépenses totales du personnel pour 2023 étaient de 4 500 000 $.
- Salaires du personnel scientifique: 3 200 000 $
- Personnel administratif: 1 000 000 $
- Recrutement et formation: 300 000 $
Maintenance de technologie et d'infrastructure
Les coûts de technologie et d'infrastructure pour 2023 s'élevaient à 1 800 000 $.
| Catégorie d'infrastructure | Montant ($) |
|---|---|
| Équipement de recherche | 900,000 |
| Systèmes informatiques et logiciels | 600,000 |
| Entretien d'installation | 300,000 |
Pasithea Therapeutics Corp. (KTTA) - Modèle d'entreprise: Strots de revenus
Ventes potentielles de produits pharmaceutiques
Depuis le quatrième trimestre 2023, Pasithea Therapeutics n'a pas généré des revenus de produits commerciaux. L'objectif principal de l'entreprise reste sur le développement de traitements thérapeutiques pour les problèmes de santé mentale.
Subventions de recherche
| Source d'octroi | Montant | Année |
|---|---|---|
| National Institutes of Health (NIH) | $375,000 | 2023 |
| Recherche sur l'innovation des petites entreprises (SBIR) | $250,000 | 2022 |
Financement de recherche collaborative
En 2023, Pasithea Therapeutics a obtenu des partenariats de financement de recherche collaborative avec les organisations suivantes:
- Centre de recherche sur les neurosciences de l'Université de Stanford: 500 000 $
- Laboratoire d'innovation en santé mentale de l'Université de Californie: 425 000 $
Licence de propriété intellectuelle
Valeur du portefeuille de propriété intellectuelle actuelle: 3,2 millions de dollars
| Catégorie de brevet | Nombre de brevets | Revenus de licence potentielle |
|---|---|---|
| Thérapies à base de kétamine | 4 | 1,5 million de dollars |
| Protocoles de traitement de santé mentale | 3 | 1,7 million de dollars |
Royalités de traitement thérapeutique futures
Projeté de revenus potentiels de redevances à partir d'essais cliniques en cours:
- Protocole de traitement de la dépression: potentiel de redevance annuel estimé de 750 000 $
- Approche thérapeutique du SSPT: potentiel de redevance annuel estimé de 650 000 $
Pasithea Therapeutics Corp. (KTTA) - Canvas Business Model: Value Propositions
You're looking at the core value Pasithea Therapeutics Corp. is putting on the table for its different customer segments as of late 2025. It's a dual-pronged approach: cutting-edge oncology/rare disease drug development and specialized CNS/pain therapeutics.
For the oncology and rare disease space, the primary value is the novel, next-generation MEK inhibitor, PAS-004. This is a macrocyclic inhibitor targeting the MAPK pathway, which is central to RASopathies and various tumors. The clinical data supports this value proposition:
- Interim Phase 1 data showed a disease control rate of 71.4% in patients with BRAF-mutated tumors.
- One patient with stage 4 BRAF-mutated melanoma experienced over 5 months of stable disease, with a tumor volume reduction of 14.9%.
- Preliminary pERK inhibition, indicating target engagement, reached up to 91% in the 8mg capsule cohort.
- As of April 2, 2025, 21 patients had been enrolled across six dose cohorts in the advanced cancer trial.
The potential treatment for high-unmet-need diseases is directly tied to PAS-004's application beyond oncology. For Neurofibromatosis Type 1 (NF1), the value is a novel option where current FDA-approved MEK inhibitors, like Koselugo, are limited to pediatric use for NF1-PN. The market need is significant, as NF1 affects approximately 1 in 3,000 births. Furthermore, the company is expanding its scope into neurodegeneration, evidenced by the ALS Association awarding a grant of $1 million to study PAS-004 in Amyotrophic Lateral Sclerosis (ALS) patients.
For the mental health and pain segments, the value proposition centers on proprietary formulations designed for specific needs, rather than just the physical clinic footprint, which I don't have specific operational numbers for right now. You have:
- PAS001: A novel psychedelic therapeutic leveraging N,N-Dimethyltryptamine (DMT) aimed at treatment-resistant depression, offering potential advantages in rapid onset and short duration for efficient administration.
- PAS002: A proprietary ketamine formulation engineered for chronic pain syndromes, focusing on modulating central sensitization mechanisms for sustained benefit.
The financial underpinning supporting the development of these value drivers is the recent capital raise. Pasithea Therapeutics Corp. priced a public offering of 80 million shares at $0.75 per share in December 2025, securing $60 million in net proceeds. This financing is explicitly intended to extend the cash runway through at least the first half of 2028, supporting ongoing clinical trials and development across the pipeline. To give you a sense of the current valuation context, the company's market capitalization was reported at $26.21 million following the offering period.
Here's a quick look at the key pipeline assets and their associated data points:
| Value Proposition Asset | Indication Focus | Key Metric/Data Point | Date/Context |
| PAS-004 | Advanced Solid Tumors (BRAF-mutated) | 71.4% Disease Control Rate | ASCO 2025 Interim Data |
| PAS-004 | NF1-associated Plexiform Neurofibromas | Targeted for adult patients; NF1 prevalence: 1 in 3,000 births | Pipeline Focus |
| PAS-004 | ALS | Awarded $1 million grant for study | November 2025 |
| PAS001 | Treatment-Resistant Depression | DMT-based therapeutic | Product Pipeline |
| Corporate Funding | Pipeline Advancement | $60 million offering at $0.75 per share | December 2025 |
The company's financial position, as of the Q3 2025 filing, showed a current ratio of 4.02, suggesting short-term liquidity strength before the December financing. The operational focus is clearly on advancing these specific, high-potential molecules through clinical milestones.
Pasithea Therapeutics Corp. (KTTA) - Canvas Business Model: Customer Relationships
You're looking at the relationships Pasithea Therapeutics Corp. maintains with its various stakeholders, which are quite distinct across its clinical development and clinic service arms. These relationships are critical, especially following significant capital events.
High-touch, personalized care model for Pasithea Clinics patients
Pasithea Therapeutics Corp. offers services that include dedicated clinics as part of its operational scope. While specific patient volumes or revenue figures directly attributable to the personalized care model at Pasithea Clinics for the 2025 fiscal year are not publicly detailed in recent filings, the company's reported revenue for 2025 was less than USD$1m, with a figure of $0 noted in some analyses. This suggests the clinic operations, while a stated service component, do not form the primary revenue base as of late 2025. The relationship here is built on direct service provision, which is a key part of their overall business structure.
Intensive Investor Relations (IR) to manage sentiment following dilutive financing
Investor relationships are currently dominated by the need to manage sentiment following a major equity event. Pasithea Therapeutics Corp. announced the closing of a public offering on December 2, 2025, which generated gross proceeds of approximately $60 million. This involved the issuance of 80,000,000 common shares or pre-funded warrants at a price of $0.75 per share. This capital raise was crucial, as the company reported cash and cash equivalents of only $4.1 million as of September 30, 2025, with existing cash expected to fund operations only through December 2025. The stated expectation is that this funding extends the cash runway through at least the first half of 2028. The relationship management involves communicating the use of net proceeds for general corporate purposes, including ongoing research and clinical trials, to a shareholder base that has seen substantial dilution. The stock price on December 1, 2025, was $1.16 / share, down 60.94% from December 2, 2024.
Here's a quick look at the key figures from the late 2025 financing event:
| Metric | Value | Date/Context |
| Gross Proceeds Raised | $60 million | December 2, 2025 Offering Close |
| Shares/Warrants Issued | 80,000,000 | December 2025 Offering |
| Offering Price per Share | $0.75 | November 28, 2025 Pricing |
| Cash Runway Extension | Through first half of 2028 | Post-Financing Projection |
| Cash on Hand (Pre-Offering) | $4.1 million | September 30, 2025 |
Direct relationships with Principal Investigators and clinical trial sites
The relationships with clinical sites are directly tied to the development of the lead candidate, PAS-004. As of early 2025, the company had four open sites in the United States (Texas and Virginia). By January 2025, Pasithea Therapeutics Corp. opened three additional clinical trial sites in Eastern Europe (Romania and Bulgaria). Further expansion included announcing the activation of clinical trial sites in South Korea in September 2025. The company is collaborating in the U.S. with NEXT Oncology, led by Dr. Anthony Tolcher M.D., and Dr. Ildefonso Rodriguez M.D. acts as principal investigator for the San Antonio, TX site. The completion of Cohort 7 in the Phase 1 trial for advanced cancer patients was announced on November 24, 2025.
The network of clinical engagement includes:
- Four U.S. sites activated as of January 2025.
- Three European sites opened in Romania and Bulgaria by January 2025.
- Site activation announced in South Korea in September 2025.
- Completion of Cohort 7 in Phase 1 trial reported November 2025.
Regulatory engagement with the FDA for drug development milestones
Engagement with the U.S. Food and Drug Administration (FDA) is foundational for the PAS-004 program. This relationship was marked by the FDA approval of the Investigational New Drug (IND) application for PAS-004. Furthermore, the FDA reviewed the protocol for the Phase 1 multicenter, open-label trial. The objective of this trial is to assess safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD), and to define the preliminary recommended Phase 2 dose. The company also announced a $1 million award from the ALS Association in November 2025 to study PAS-004 for ALS treatment.
Pasithea Therapeutics Corp. (KTTA) - Canvas Business Model: Channels
The distribution and access strategy for Pasithea Therapeutics Corp. (KTTA) centers on clinical development pathways and direct patient access through its subsidiary clinics, leveraging both physical presence and scientific communication.
The primary channel for advancing the lead candidate, PAS-004, is through a multi-center clinical trial network. As of early 2025, this network was strategically expanded to cover key geographies for patient recruitment and data diversity.
| Channel Component | Location Type | Count/Status (as of Jan 2025) | Associated Trial/Activity |
| Clinical Trial Sites | United States | 4 open sites | PAS-004 Phase 1 Trial |
| Clinical Trial Sites | Eastern Europe (Romania and Bulgaria) | 3 opened sites | PAS-004 Phase 1 Trial |
| Total Active Sites | Global | 7 total sites | Patient Recruitment |
This expansion to seven total clinical sites-four in the US and three in Eastern Europe-was designed to accelerate patient enrollment for the ongoing Phase 1 study of PAS-004.
For direct patient engagement, the wholly owned subsidiary, Pasithea Clinics, utilizes physical locations for in-person treatments. In London, the Company had existing locations in Marylebone and Knightsbridge and planned to open three new clinics by mid-2022, with each clinic projected to contribute an estimated USD$5 million annually in revenue based on 2022 projections. The Company's headquarters is listed in Miami Beach, FL.
Regarding mobile/at-home services, the search results confirm the offering of ketamine therapy at the UK clinic locations, but specific operational details, such as the number of major US cities covered (e.g., NYC, LA, Florida) or associated patient volumes for mobile/at-home IV ketamine services in the US as of late 2025, are not present in the latest filings reviewed.
Dissemination of trial data and corporate visibility is achieved through scientific publications and key industry events. Pasithea Therapeutics Corp. management presented at the H.C. Wainwright 27th Annual Global Investment Conference in New York City between September 8-10, 2025. Furthermore, the Company announced plans to present interim safety and pharmacokinetic (PK) data from PAS-004 Cohorts 4A and 4B in Q1 2025. A significant non-dilutive channel for validation was the $1 Million Award by ALS Association announced on November 25, 2025.
The Channels strategy relies on these distinct avenues:
- - Multi-center clinical trial sites in the US and Eastern Europe for PAS-004, totaling 7 active sites as of January 2025.
- - Pasithea Clinics: Physical locations, including established sites in London (e.g., Marylebone, Knightsbridge) with a projected annual revenue benchmark of USD$5 million per planned new clinic from 2022 estimates.
- - Mobile/At-home IV ketamine services in major US cities (e.g., NYC, LA, Florida), for which specific 2025 operational metrics are not detailed.
- - Scientific publications and conferences (e.g., H.C. Wainwright) to disseminate trial data, with management presenting at the September 2025 conference.
Pasithea Therapeutics Corp. (KTTA) - Canvas Business Model: Customer Segments
You're looking at the core groups Pasithea Therapeutics Corp. (KTTA) serves or relies on as of late 2025. It's a mix of patients needing novel therapies and the capital markets that fund the science.
The patient segments are defined by the indications for their lead candidate, PAS-004, a next-generation macrocyclic oral MEK inhibitor.
| Customer Segment Category | Target Indication/Role | Relevant Statistical/Financial Data Point |
| Patients with MAPK pathway-driven advanced solid tumors and RASopathies (e.g., NF1) | Advanced Solid Tumors (Phase 1) | As of April 2, 2025, 21 patients had been enrolled in the Phase 1 study. Common diagnoses included pancreatic cancer (28.6%), colorectal cancer (28.6%), and melanoma (23.8%). |
| Patients with MAPK pathway-driven advanced solid tumors and RASopathies (e.g., NF1) | Neurofibromatosis Type 1 (NF1) | NF1 occurs in about 1 in 3,000 births. |
| Patients with treatment-resistant mental health disorders (TRD, PTSD) | CNS Disorders Pipeline Expansion | Received a $1 million award from the ALS Association to study PAS-004 in Amyotrophic Lateral Sclerosis (ALS). |
| Institutional and retail investors funding the clinical-stage biotech pipeline | Financing/Capital Providers | Closed a public offering generating gross proceeds of approximately $60 million on December 2, 2025. The company's enterprise value stood at $117 million in late November 2025. |
| Academic and research institutions for potential future collaborations | Research & Development Partners | Received a $1 million non-dilutive grant from the ALS Association. |
The investor base that participated in the late 2025 financing is specific, showing institutional focus on the clinical-stage assets.
- Healthcare-dedicated investors leading the December 2025 offering included Vivo Capital, Janus Henderson Investors, Coastlands Capital, Columbia Threadneedle Investments, Adage Capital Partners, and Squadron Capital Management.
- The $60 million gross proceeds from the offering are intended to extend the cash runway through at least the first half of 2028.
- The offering price was set at $0.75 per share of common stock or pre-funded warrant.
For the patient populations, the clinical trial enrollment provides concrete numbers on the initial addressable market being tested.
- In the advanced cancer trial, the efficacy evaluable population was n=16 as of the April 2, 2025 cut-off date.
- One patient with KRAS G12R-mutated pancreatic cancer achieved a tumor diameter reduction of -9.8%.
The academic segment is directly evidenced by the recent grant activity.
- The $1 million ALS Association award supports studying PAS-004 in ALS, expanding the pipeline into a third neurological indication.
Pasithea Therapeutics Corp. (KTTA) - Canvas Business Model: Cost Structure
You're looking at the cost side of Pasithea Therapeutics Corp. (KTTA), and honestly, for a clinical-stage biotech, it's almost entirely driven by the science and the corporate infrastructure needed to support it. The numbers we have, based on the nine months ending September 30, 2025, show where the cash is going before any product revenue starts flowing in.
The biggest chunk of your spending is definitely tied up in the development pipeline, specifically for PAS-004. This is where the money goes to run the clinical trials, which are the make-or-break moments for any drug candidate. You have to fund the science, no way around it.
Here's a quick look at the major operating expenses for the nine months ended September 30, 2025, which gives you a clear picture of the burn rate:
| Expense Category | Amount (9 Months Ended Sep 30, 2025) |
| Research and Development (R&D) | $5,236,320 |
| General and Administrative (G&A) | $5,364,813 |
| Total Reported Operating Expenses (R&D + G&A) | $10,601,133 |
The General and Administrative (G&A) costs are substantial, reflecting the necessary overhead to operate as a publicly traded entity on NASDAQ. This includes everything from executive salaries to compliance, legal fees, and maintaining that public listing status. It's the cost of being a company, not just a lab.
For the network of Pasithea Clinics, their operating costs-staffing, rent, and supplies for patient care and potentially clinical trial support-are embedded within these reported figures, primarily within the G&A structure, as a separate operating cost line item isn't broken out in the latest filings. You're paying for the infrastructure that supports the CNS disorder focus.
To put the overall financial performance in context, the company was operating at a significant loss, which is typical for this stage of development. The net loss for the trailing 12 months ending September 30, 2025, was approximately -$13.5 million. That's the bottom line you need to cover with financing.
Speaking of financing, you should note the recent capital raise. Pasithea Therapeutics Corp. priced a public offering of 80 million shares at $0.75 each in late November 2025, bringing in around $60 million. This cash infusion is explicitly intended to fund the PAS-004 development and clinical trials, aiming to extend the cash runway through at least mid-2028. That new capital directly offsets the current cost structure by providing a longer operational runway.
Key components driving the R&D spend include:
- Significant Research and Development (R&D) expenses for PAS-004 clinical trials.
- Funding Phase 1 studies for the MEK inhibitor.
- Costs associated with CNS disorder and RASopathies research translation.
The G&A costs cover the corporate necessities:
- Costs associated with maintaining NASDAQ listing compliance.
- Corporate overhead and executive compensation.
- General operational and administrative staffing.
Finance: draft the projected monthly cash burn based on the 9-month operating expense run rate by end of day Tuesday.
Pasithea Therapeutics Corp. (KTTA) - Canvas Business Model: Revenue Streams
You're looking at the revenue side of Pasithea Therapeutics Corp. (KTTA) as of late 2025, and honestly, it's what you'd expect from a clinical-stage biotech heavily focused on drug development. The primary financial inflows right now aren't from product sales; they are from financing activities and targeted research support. This is a company funding its pipeline, not yet selling a commercial product.
The most significant recent cash infusion came from the capital markets. Pasithea Therapeutics Corp. priced a public offering of common stock in late November 2025, which closed on December 2, 2025. This move generated gross proceeds of approximately \$60 million before accounting for placement agent fees and other expenses. That capital is key; the company stated the net proceeds are intended to extend its cash runway through at least the first half of 2028.
Beyond equity raises, non-dilutive funding provides crucial, non-equity-cost support for specific research initiatives. For instance, Pasithea Therapeutics Corp. secured a Hoffman ALS Clinical Trial Award grant from the ALS Association worth approximately \$1 million in November 2025. This grant is earmarked specifically to study their lead candidate, PAS-004, in patients with Amyotrophic Lateral Sclerosis.
Here's a quick look at how these major funding events stack up against the company's reported operational revenue status:
| Revenue Source Category | Specific Event/Service | Amount/Value | Date/Period |
|---|---|---|---|
| Equity Financing | Public Offering Gross Proceeds | $60 million | Late 2025 (Closed Dec 2, 2025) |
| Non-Dilutive Funding | ALS Association Hoffman Award | Approximately $1 million | November 2025 |
| Operational Services | Fees for IV ketamine and rTMS services | Fees for IV ketamine and rTMS mental health services from Pasithea Clinics | Ongoing (Pasithea Clinics) |
| Drug Development Status | Trailing 12-Month Revenue | $0.00 | Ending June 30, 2025 |
The company maintains a revenue stream from its clinical operations, which are separate from the drug development pipeline. This involves the Pasithea Clinics segment. The revenue here is generated from fees for IV ketamine and rTMS mental health services from Pasithea Clinics. Still, the overall picture for the drug development side remains pre-commercial, which is reflected in the official filings.
The official financial reporting confirms the pre-commercial status of the primary business focus. Current trailing 12-month revenue ending June 30, 2025, was reported as \$0.00. This \$0.00 figure is typical for a clinical-stage biotechnology firm whose primary value driver is its pipeline assets, not current sales volume.
To summarize the key components of the Revenue Streams block for Pasithea Therapeutics Corp. as of late 2025, you see a reliance on non-operating income to fuel operations:
- - Capital raising through equity offerings, generating $60 million gross proceeds in late 2025.
- - Non-dilutive grant funding, such as the $1 million from the ALS Association.
- - Fees for IV ketamine and rTMS mental health services from Pasithea Clinics.
- - Current trailing 12-month revenue ending June 30, 2025, was reported as $0.00, reflecting pre-commercial status.
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