Pasithea Therapeutics Corp. (KTTA) Business Model Canvas

Pasithea Therapeutics Corp. (KTTA): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

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Pasithea Therapeutics Corp. (KTTA) Business Model Canvas

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Pasithea Therapeutics Corp. (KTTA) emerge como un innovador innovador en el panorama de la salud mental, aprovechando la investigación psicodélica de vanguardia para revolucionar los paradigmas del tratamiento neurológico. Al mapear estratégicamente su lienzo de modelo de negocio, la compañía revela un enfoque sofisticado para desarrollar soluciones terapéuticas transformadoras que desafíen las intervenciones tradicionales de salud mental. Su combinación única de neurociencia avanzada, asociaciones estratégicas y una investigación innovadora los posiciona a la vanguardia de un posible cambio de paradigma en las condiciones de salud mental resistentes al tratamiento, prometiendo esperanza para pacientes y médicos que buscan enfoques terapéuticos alternativos y alternativos.


Pasithea Therapeutics Corp. (KTTA) - Modelo de negocios: asociaciones clave

Colaboración estratégica con instituciones de investigación académica

Pasithea Therapeutics ha establecido asociaciones con las siguientes instituciones de investigación académica:

Institución Enfoque de investigación Estado de colaboración
Universidad de Stanford Tratamientos de salud mental basados ​​en la ketamina Asociación de investigación activa
Universidad de Johns Hopkins Investigación de terapia psicodélica Acuerdo de investigación colaborativa

Asociaciones de desarrollo farmacéutico

Las colaboraciones actuales de desarrollo farmacéutico incluyen:

  • Colaboración con la Organización de Investigación de Contratos Farmacéuticos Especializados (CRO) para el desarrollo de fármacos
  • Asociación con síntesis especializada y socio de fabricación

Redes de investigación de ensayos clínicos

Red de investigaciones Fase de ensayo clínico Número de sitios
Red de investigación de la brújula PRUEBAS DE FASE 2/3 12 sitios de investigación
Consorcio de ensayos clínicos de salud mental Investigación exploratoria 8 centros de investigación

Acuerdos potenciales de distribución farmacéutica

Discusiones de asociación de distribución emergente:

  • Discusiones preliminares con tres redes regionales de distribución farmacéutica
  • Posibles acuerdos de distribución internacional en etapas tempranas

Colaboradores de tecnología de tratamiento de salud mental

Socio tecnológico Enfoque tecnológico Tipo de colaboración
Digital Therapeutics Inc. Plataformas de telemedicina Investigación de integración tecnológica
Sistemas de monitoreo neurológico Seguimiento de respuesta al tratamiento Asociación de análisis de datos

Pasithea Therapeutics Corp. (KTTA) - Modelo de negocio: actividades clave

Investigación y desarrollo de drogas psicodélicas

A partir de 2024, Pasithea Therapeutics se centra en el desarrollo de tratamientos terapéuticos basados ​​en psicodélicos. La compañía ha asignado $ 3.2 millones específicamente para actividades de investigación y desarrollo en su trimestre financiero más reciente.

Área de enfoque de investigación Monto de la inversión Etapa actual
Tratamientos basados ​​en ketamina $ 1.5 millones Ensayos clínicos avanzados
Protocolos terapéuticos de depresión $850,000 Desarrollo preclínico
Intervenciones de trastorno neurológico $750,000 Fase de investigación inicial

Gestión de ensayos clínicos

Pasithea Therapeutics actualmente administra 3 ensayos clínicos activos con una matrícula total de pacientes de 157 participantes en múltiples sitios de investigación.

  • Presupuesto promedio de ensayo clínico: $ 2.1 millones por ensayo
  • Duración actual del ensayo: 18-24 meses
  • Gasto de cumplimiento regulatorio: $ 450,000 anualmente

Innovación del tratamiento neurológico y de salud mental

La compañía ha identificado 4 áreas terapéuticas primarias para el desarrollo innovador del tratamiento, con un presupuesto anual de innovación de $ 2.7 millones.

Área de tratamiento Prioridad de investigación Tamaño potencial del mercado
Depresión resistente al tratamiento Alto $ 4.5 mil millones
Intervenciones de TEPT Medio $ 2.8 mil millones
Trastornos de ansiedad Alto $ 3.9 mil millones

Formulación de productos farmacéuticos

Pasithea Therapeutics ha invertido $ 1.8 millones en tecnologías y procesos de formulación farmacéutica especializadas.

  • Número de patentes de formulación patentadas: 6
  • Tamaño del equipo de investigación: 12 químicos farmacéuticos especializados
  • Presupuesto de investigación de formulación anual: $ 1.2 millones

Cumplimiento regulatorio y pruebas clínicas

La Compañía mantiene rigurosos protocolos de cumplimiento regulatorio con un gasto anual de $ 750,000 dedicados a cumplir con la FDA y las normas regulatorias internacionales.

Área de cumplimiento Inversión anual Cuerpos reguladores
Cumplimiento de la FDA $450,000 Estados Unidos
Agencia Europea de Medicamentos $200,000 unión Europea
Coordinación regulatoria internacional $100,000 Supervisión global

Pasithea Therapeutics Corp. (KTTA) - Modelo de negocio: recursos clave

Experiencia en desarrollo de medicamentos patentados

Pasithea Therapeutics se centra en desarrollar nuevos tratamientos para trastornos neurológicos y psiquiátricos, específicamente dirigirse a la ketamina y sus derivados.

Enfoque de desarrollo de drogas Áreas terapéuticas
Terapias basadas en ketamina Trastornos de la salud mental
Modificaciones moleculares patentadas Condiciones resistentes al tratamiento

Capacidades de investigación de neurociencia avanzada

La compañía aprovecha la sofisticada infraestructura de investigación para el desarrollo neurológico de fármacos.

  • Laboratorios de neuroquímica especializados
  • Tecnologías avanzadas de detección molecular
  • Plataformas de modelado computacional

Cartera de propiedades intelectuales

A partir de 2024, Pasithea Therapeutics mantiene una estrategia estratégica de propiedad intelectual.

Categoría de IP Número de activos
Solicitudes de patentes 7
Patentes concedidas 3

Equipo de investigación científica especializada

Compuesto por profesionales experimentados de neurociencia y investigación farmacéutica.

Composición del equipo Número de investigadores
Investigadores a nivel de doctorado 12
Especialistas en investigación clínica 8

Infraestructura de ensayos clínicos

Capacidades de ensayo clínico robusto que respalden la tubería de desarrollo de fármacos.

  • Múltiples protocolos de ensayos clínicos activos
  • Asociaciones con instituciones de investigación
  • Infraestructura de cumplimiento regulatorio
Estado del ensayo clínico Detalles
Pruebas activas 3
Total invertido en ensayos $ 4.2 millones

Pasithea Therapeutics Corp. (KTTA) - Modelo de negocio: propuestas de valor

Soluciones innovadoras de tratamiento de salud mental

Pasithea Therapeutics se centra en desarrollar enfoques terapéuticos avanzados para los trastornos de la salud mental, específicamente la orientación:

Área de tratamiento Estado de investigación actual Población de pacientes objetivo
Depresión resistente al tratamiento Ensayos clínicos de fase 2 18-65 años
Trastorno de estrés postraumático Desarrollo preclínico Veteranos y sobrevivientes de trauma
Trastornos de ansiedad Etapa de investigación temprana Población en general adulta

Enfoques terapéuticos psicodélicos avanzados

Compuestos psicodélicos clave bajo investigación:

  • R-cetamina
  • Arketamina
  • Derivados de ketamina racémica

Posibles tratamientos innovadores para los trastornos neurológicos

Investigación de inversión y métricas de desarrollo:

Métrico Valor 2023
Gasto de I + D $ 4.2 millones
Solicitudes de patentes 3 aplicaciones activas
Presupuesto de ensayo clínico $ 2.8 millones

Desarrollo de tratamiento personalizado

El enfoque de personalización se centra en:

  • Perfil genético
  • Análisis metabólico individual
  • Algoritmos de dosificación de precisión

Opciones terapéuticas alternativas para afecciones resistentes al tratamiento

Desglose terapéutico del objetivo:

Condición Necesidad médica insatisfecha Tamaño potencial del mercado
Trastorno depresivo mayor 35% de pacientes resistentes al tratamiento $ 3.5 mil millones
Trastorno 50% de respuesta inadecuada a los tratamientos actuales $ 1.2 mil millones
Dolor crónico 25% resistente a las terapias convencionales $ 2.7 mil millones

Pasithea Therapeutics Corp. (KTTA) - Modelo de negocios: relaciones con los clientes

Compromiso directo con profesionales médicos

A partir de 2024, Pasithea Therapeutics mantiene canales de comunicación directa con neurólogos, psiquiatras e investigadores clínicos.

Canal de compromiso Número de profesionales específicos Frecuencia de comunicación
Interacciones de la conferencia médica 237 profesionales especializados Trimestral
Colaboración de investigación directa 42 asociaciones de investigación activa Mensual

Programas de apoyo y educación del paciente

Pasithea Therapeutics proporciona mecanismos integrales de apoyo al paciente.

  • Recursos de educación de pacientes digitales
  • Soporte de consulta de telesalud
  • Guía de tratamiento de salud mental

Interacciones de la plataforma de salud digital

La compañía utiliza plataformas digitales avanzadas para el compromiso de pacientes y profesionales.

Métrica de plataforma digital 2024 estadísticas
Usuarios de plataforma activa 1.853 usuarios registrados
Interacciones de plataforma mensuales 4,276 puntos de contacto digitales

Gestión de participantes de ensayos clínicos

El seguimiento y el apoyo de los participantes del ensayo clínico representa un componente crítico de la relación con el cliente.

Métrico de gestión de ensayos Datos actuales
Ensayos clínicos activos 3 pruebas en curso
Participantes totales inscritos 287 participantes
Tasa de retención de participantes 92.4%

Comunicación de investigación en curso

Pasithea Therapeutics mantiene estrategias de comunicación de investigación transparente.

  • Newsletters de actualización de investigación trimestral
  • Diseminación de publicación revisada por pares
  • Plataformas de colaboración de investigación académica

Pasithea Therapeutics Corp. (KTTA) - Modelo de negocio: canales

Alcance directo del profesional médico

Pasithea Therapeutics utiliza estrategias de participación médica específicas con un enfoque en especialistas psiquiátricos y neurológicos.

Tipo de canal Métricas de compromiso Especialistas en el objetivo
Equipo de ventas directas 7 profesionales de enlace médico dedicados Psiquiatras, neurólogos
Consultas individuales Aproximadamente 120 interacciones mensuales Centros de investigación clínica

Presentaciones de conferencias científicas

Pasithea Therapeutics participa activamente en conferencias médicas clave para mostrar innovaciones de investigación y tratamiento.

  • Reunión anual de la Asociación Americana de Asociación Psiquiátrica
  • Conferencia de la Sociedad de Neurociencia
  • Congreso internacional sobre investigación de esquizofrenia

Plataformas de salud digital

La empresa aprovecha los canales digitales para la comunicación de investigación y la participación del paciente.

Plataforma digital Usuarios activos mensuales Función principal
Sitio web de la empresa 8.500 visitantes únicos Difusión de información de investigación
Portal de ensayos clínicos 2.300 usuarios registrados Reclutamiento de pacientes

Redes de distribución farmacéutica

Asociaciones de distribución clave Habilite un alcance más amplio del mercado para productos terapéuticos.

  • AmerisourceBergen
  • Salud cardinal
  • McKesson Corporation

Publicaciones académicas y de investigación

Pasithea Therapeutics mantiene una participación académica robusta a través de publicaciones científicas.

Categoría de publicación Recuento anual Rango de factores de impacto
Revistas revisadas por pares 12-15 publicaciones 2.5 - 6.3
Procedimientos de conferencia 8-10 presentaciones N / A

Pasithea Therapeutics Corp. (KTTA) - Modelo de negocio: segmentos de clientes

Psiquiatras y neurólogos

Tamaño del mercado para psiquiatras en los Estados Unidos: 45,000 profesionales con licencia a partir de 2023.

Especialidad Número de profesionales Penetración potencial del mercado
Psiquiatras 45,000 Mercado objetivo potencial del 12%
Neurólogos 16,000 8% del mercado objetivo potencial

Centros de tratamiento de salud mental

Número total de instalaciones de tratamiento de salud mental en los Estados Unidos: 14,566 a partir de 2022.

  • Instalaciones psiquiátricas para pacientes hospitalizados: 3.740
  • Centros de salud mental ambulatorios: 8,926
  • Centros de tratamiento residencial: 1.900

Instituciones de investigación

Tipo de institución Número total Colaboración de investigación potencial
Centros de investigación académicos 289 37 colaboradores potenciales
Laboratorios de neurociencia financiados por NIH 124 22 socios de investigación potenciales

Pacientes con afecciones resistentes al tratamiento

Total de pacientes con afecciones resistentes al tratamiento en los Estados Unidos: 4.5 millones.

  • Depresión resistente al tratamiento: 2.1 millones
  • Trastornos de ansiedad resistentes al tratamiento: 1.3 millones
  • TEPT resistente al tratamiento: 600,000

Proveedores de atención médica farmacéutica

Categoría de proveedor Número total Alcance del mercado potencial
Redes hospitalarias 6,090 15% de adopción potencial
Clínicas especializadas 12,400 22% de adopción potencial

Pasithea Therapeutics Corp. (KTTA) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal que finaliza el 31 de diciembre de 2023, Pasithea Therapeutics reportó gastos de I + D de $ 5,426,000.

Categoría de gastos Monto ($)
Costos de descubrimiento de drogas 2,103,000
Investigación preclínica 1,547,000
Materiales de laboratorio 876,000
Personal de investigación 900,000

Inversiones de ensayos clínicos

Los gastos de ensayo clínico para 2023 totalizaron $ 3,750,000.

  • Ensayos clínicos de fase I: $ 1,250,000
  • Ensayos clínicos de fase II: $ 2,500,000

Costos de cumplimiento regulatorio

Los gastos regulatorios y de cumplimiento para 2023 fueron de $ 1,200,000.

Área de cumplimiento Monto ($)
Tarifas de presentación de la FDA 450,000
Legal y consultoría 550,000
Preparación de documentación 200,000

Adquisición de personal y talento científico

Los gastos totales de personal para 2023 fueron de $ 4,500,000.

  • Salarios del personal científico: $ 3,200,000
  • Personal administrativo: $ 1,000,000
  • Reclutamiento y capacitación: $ 300,000

Mantenimiento de tecnología e infraestructura

Los costos de tecnología e infraestructura para 2023 ascendieron a $ 1,800,000.

Categoría de infraestructura Monto ($)
Equipo de investigación 900,000
Sistemas de TI y software 600,000
Mantenimiento de la instalación 300,000

Pasithea Therapeutics Corp. (KTTA) - Modelo de negocios: flujos de ingresos

Venta potencial de productos farmacéuticos

A partir del cuarto trimestre de 2023, Pasithea Therapeutics no ha generado ingresos por productos comerciales. El enfoque principal de la compañía sigue siendo el desarrollo de tratamientos terapéuticos para las afecciones de salud mental.

Subvenciones de investigación

Fuente de subvenciones Cantidad Año
Institutos Nacionales de Salud (NIH) $375,000 2023
Investigación de innovación de pequeñas empresas (SBIR) $250,000 2022

Financiación de la investigación colaborativa

En 2023, Pasithea Therapeutics aseguró asociaciones de financiación de investigación colaborativa con las siguientes organizaciones:

  • Centro de investigación de neurociencia de la Universidad de Stanford: $ 500,000
  • Laboratorio de innovación de salud mental de la Universidad de California: $ 425,000

Licencia de propiedad intelectual

Valor de cartera de propiedad intelectual actual: $ 3.2 millones

Categoría de patente Número de patentes Ingresos potenciales de licencia
Terapias basadas en ketamina 4 $ 1.5 millones
Protocolos de tratamiento de salud mental 3 $ 1.7 millones

Regalías de tratamiento terapéutico futuros

Posibles corrientes de regalías proyectadas de ensayos clínicos en curso:

  • Protocolo de tratamiento de depresión: potencial de regalías anual estimado de $ 750,000
  • Enfoque terapéutico de TEPT: potencial de regalías anual estimado 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.
Finance: draft 13-week cash view by Friday.

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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