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Pasithea Therapeutics Corp. (KTTA): Modelo de Negócios Canvas [Jan-2025 Atualizado] |
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Pasithea Therapeutics Corp. (KTTA) Bundle
A Pasithea Therapeutics Corp. (KTTA) surge como um inovador inovador no cenário da saúde mental, alavancando pesquisas psicodélicas de ponta para revolucionar os paradigmas de tratamento neurológico. Ao mapear estrategicamente sua tela de modelo de negócios, a empresa revela uma abordagem sofisticada para o desenvolvimento de soluções terapêuticas transformadoras que desafiam as intervenções tradicionais de saúde mental. Sua mistura única de neurociência avançada, parcerias estratégicas e pesquisas inovadoras os posiciona na vanguarda de uma potencial mudança de paradigma nas condições de saúde mental resistentes ao tratamento, promissor esperança para pacientes e médicos que buscam abordagens terapêuticas alternativas e personalizadas.
Pasithea Therapeutics Corp. (KTTA) - Modelo de negócios: Parcerias -chave
Colaboração estratégica com instituições de pesquisa acadêmica
A Pasithea Therapeutics estabeleceu parcerias com as seguintes instituições de pesquisa acadêmica:
| Instituição | Foco na pesquisa | Status de colaboração |
|---|---|---|
| Universidade de Stanford | Tratamentos de saúde mental à base de cetamina | Parceria de pesquisa ativa |
| Universidade Johns Hopkins | Pesquisa de terapia psicodélica | Acordo de Pesquisa Colaborativa |
Parcerias de desenvolvimento farmacêutico
As colaborações atuais de desenvolvimento farmacêutico incluem:
- Colaboração com Organização Especializada de Pesquisa em Contrato Farmacêutico (CRO) para Desenvolvimento de Medicamentos
- Parceria com parceiro de síntese e fabricação especializado
Redes de pesquisa de ensaios clínicos
| Rede de pesquisa | Fase de ensaios clínicos | Número de sites |
|---|---|---|
| Rede de Pesquisa de Compass | Ensaios de Fase 2/3 | 12 sites de pesquisa |
| Consórcio de ensaios clínicos de saúde mental | Pesquisa exploratória | 8 centros de pesquisa |
Acordos potenciais de distribuição farmacêutica
Discussões emergentes de parceria de distribuição:
- Discussões preliminares com três redes de distribuição farmacêutica regional
- Potenciais acordos de distribuição internacional em estágios iniciais
Colaboradores de tecnologia de tratamento de saúde mental
| Parceiro de tecnologia | Foco em tecnologia | Tipo de colaboração |
|---|---|---|
| Digital Therapeutics Inc. | Plataformas de telemedicina | Pesquisa de integração de tecnologia |
| Sistemas de monitoramento neurológico | Rastreamento de resposta ao tratamento | Parceria de análise de dados |
Pasithea Therapeutics Corp. (KTTA) - Modelo de negócios: Atividades -chave
Pesquisa e desenvolvimento de drogas psicodélicas
A partir de 2024, a Pasithea Therapeutics se concentra no desenvolvimento de tratamentos terapêuticos psicodélicos. A empresa alocou US $ 3,2 milhões especificamente para atividades de pesquisa e desenvolvimento em seu trimestre financeiro mais recente.
| Área de foco de pesquisa | Valor do investimento | Estágio atual |
|---|---|---|
| Tratamentos à base de cetamina | US $ 1,5 milhão | Ensaios clínicos avançados |
| Protocolos terapêuticos de depressão | $850,000 | Desenvolvimento pré -clínico |
| Intervenções de transtorno neurológico | $750,000 | Fase de pesquisa inicial |
Gerenciamento de ensaios clínicos
Atualmente, a Pasithea Therapeutics gerencia 3 ensaios clínicos ativos com uma inscrição total do paciente de 157 participantes em vários locais de pesquisa.
- Orçamento médio do ensaio clínico: US $ 2,1 milhões por estudo
- Duração atual do teste: 18-24 meses
- Despesas de conformidade regulatória: US $ 450.000 anualmente
Inovação em tratamento neurológico e de saúde mental
A empresa identificou 4 áreas terapêuticas primárias para o desenvolvimento inovador de tratamento, com um orçamento anual de inovação de US $ 2,7 milhões.
| Área de tratamento | Prioridade de pesquisa | Tamanho potencial de mercado |
|---|---|---|
| Depressão resistente ao tratamento | Alto | US $ 4,5 bilhões |
| Intervenções de TEPT | Médio | US $ 2,8 bilhões |
| Transtornos de ansiedade | Alto | US $ 3,9 bilhões |
Formulação do produto farmacêutico
A Pasithea Therapeutics investiu US $ 1,8 milhão em tecnologias e processos de formulação farmacêutica especializada.
- Número de patentes de formulação proprietária: 6
- Tamanho da equipe de pesquisa: 12 químicos farmacêuticos especializados
- Orçamento anual de pesquisa de formulação: US $ 1,2 milhão
Conformidade regulatória e teste clínico
A Companhia mantém protocolos rigorosos de conformidade regulatória com uma despesa anual de US $ 750.000 dedicados ao cumprimento dos padrões regulatórios da FDA e da International.
| Área de conformidade | Investimento anual | Órgãos regulatórios |
|---|---|---|
| Conformidade da FDA | $450,000 | Estados Unidos |
| Agência Europeia de Medicamentos | $200,000 | União Europeia |
| Coordenação Regulatória Internacional | $100,000 | Supervisão global |
Pasithea Therapeutics Corp. (KTTA) - Modelo de negócios: Recursos -chave
Experiência proprietária de desenvolvimento de medicamentos
A Pasithea Therapeutics se concentra no desenvolvimento de novos tratamentos para distúrbios neurológicos e psiquiátricos, direcionando especificamente a cetamina e seus derivados.
| Foco de desenvolvimento de medicamentos | Áreas terapêuticas |
|---|---|
| Terapias à base de cetamina | Distúrbios da saúde mental |
| Modificações moleculares proprietárias | Condições resistentes ao tratamento |
Capacidades avançadas de pesquisa de neurociência
A empresa aproveita a sofisticada infraestrutura de pesquisa para o desenvolvimento de medicamentos neurológicos.
- Laboratórios de neuroquímica especializados
- Tecnologias avançadas de triagem molecular
- Plataformas de modelagem computacional
Portfólio de propriedade intelectual
A partir de 2024, a Pasithea Therapeutics mantém uma estratégia estratégica de propriedade intelectual.
| Categoria IP | Número de ativos |
|---|---|
| Aplicações de patentes | 7 |
| Patentes concedidas | 3 |
Equipe de pesquisa científica especializada
Composto por profissionais experientes em neurociência e pesquisa farmacêutica.
| Composição da equipe | Número de pesquisadores |
|---|---|
| Pesquisadores de nível de doutorado | 12 |
| Especialistas em pesquisa clínica | 8 |
Infraestrutura do ensaio clínico
Robustos recursos de ensaio clínico Apoiando o pipeline de desenvolvimento de medicamentos.
- Vários protocolos de ensaios clínicos ativos
- Parcerias com instituições de pesquisa
- Infraestrutura de conformidade regulatória
| Status do ensaio clínico | Detalhes |
|---|---|
| Ensaios ativos | 3 |
| Total investido em ensaios | US $ 4,2 milhões |
Pasithea Therapeutics Corp. (KTTA) - Modelo de negócios: proposições de valor
Soluções inovadoras de tratamento de saúde mental
A Pasithea Therapeutics se concentra no desenvolvimento de abordagens terapêuticas avançadas para distúrbios de saúde mental, direcionando especificamente:
| Área de tratamento | Status de pesquisa atual | População alvo de pacientes |
|---|---|---|
| Depressão resistente ao tratamento | Ensaios clínicos de fase 2 | 18-65 anos |
| Transtorno de estresse pós-traumático | Desenvolvimento pré -clínico | Veteranos e sobreviventes de trauma |
| Transtornos de ansiedade | Estágio inicial de pesquisa | População adulta em geral |
Abordagens terapêuticas psicodélicas avançadas
Principais compostos psicodélicos sob investigação:
- R-ceicamina
- Arketamina
- Derivados racêmicos de cetamina
Possíveis tratamentos inovadores para distúrbios neurológicos
Métricas de investimento e desenvolvimento de pesquisa:
| Métrica | 2023 valor |
|---|---|
| Despesas de P&D | US $ 4,2 milhões |
| Aplicações de patentes | 3 aplicações ativas |
| Orçamento do ensaio clínico | US $ 2,8 milhões |
Desenvolvimento de tratamento personalizado
A abordagem de personalização se concentra:
- Perfil genético
- Análise metabólica individual
- Algoritmos de dosagem de precisão
Opções terapêuticas alternativas para condições resistentes ao tratamento
Avaria terapêutica -alvo:
| Doença | Necessidade médica não atendida | Tamanho potencial de mercado |
|---|---|---|
| Transtorno depressivo maior | 35% de pacientes resistentes ao tratamento | US $ 3,5 bilhões |
| TEPT | Resposta inadequada de 50% aos tratamentos atuais | US $ 1,2 bilhão |
| Dor crônica | 25% resistentes a terapias convencionais | US $ 2,7 bilhões |
Pasithea Therapeutics Corp. (KTTA) - Modelo de Negócios: Relacionamentos do Cliente
Engajamento direto com profissionais médicos
A partir de 2024, a Pasithea Therapeutics mantém canais de comunicação direta com neurologistas, psiquiatras e pesquisadores clínicos.
| Canal de engajamento | Número de profissionais -alvo | Frequência de comunicação |
|---|---|---|
| Interações da conferência médica | 237 profissionais especializados | Trimestral |
| Colaboração de pesquisa direta | 42 Parcerias de Pesquisa Ativa | Mensal |
Programas de apoio ao paciente e educação
A Pasithea Therapeutics fornece mecanismos abrangentes de apoio ao paciente.
- Recursos de educação digital do paciente
- Suporte de consulta de telessaúde
- Orientação de tratamento de saúde mental
Interações da plataforma de saúde digital
A empresa utiliza plataformas digitais avançadas para o envolvimento do paciente e profissional.
| Métrica da plataforma digital | 2024 Estatísticas |
|---|---|
| Usuários de plataforma ativa | 1.853 usuários registrados |
| Interações mensais da plataforma | 4.276 pontos de contato digitais |
Gerenciamento de participantes do ensaio clínico
O rastreamento e suporte de participantes do ensaio clínico representa um componente crítico de relacionamento com o cliente.
| Métrica de Gerenciamento de Trial | Dados atuais |
|---|---|
| Ensaios clínicos ativos | 3 ensaios em andamento |
| Total de participantes inscritos | 287 participantes |
| Taxa de retenção dos participantes | 92.4% |
Comunicação de pesquisa em andamento
A Pasithea Therapeutics mantém estratégias de comunicação de pesquisa transparentes.
- Newsletters trimestrais de atualização de pesquisa
- Disseminação de publicação revisada por pares
- Plataformas de colaboração de pesquisa acadêmica
Pasithea Therapeutics Corp. (KTTA) - Modelo de Negócios: Canais
Diretor Médico Direto
A Pasithea Therapeutics utiliza estratégias direcionadas de envolvimento profissional médico, com foco em especialistas psiquiátricos e neurológicos.
| Tipo de canal | Métricas de engajamento | Especialistas -alvo |
|---|---|---|
| Equipe de vendas diretas | 7 Profissionais dedicados de ligação médica | Psiquiatras, neurologistas |
| Consultas individuais | Aproximadamente 120 interações mensais | Centros de Pesquisa Clínica |
Apresentações da conferência científica
A Pasithea Therapeutics participa ativamente de conferências médicas importantes para mostrar inovações de pesquisa e tratamento.
- Reunião Anual da Associação Psiquiátrica Americana
- Conferência da Sociedade para Neurociência
- Congresso Internacional de Pesquisa de Esquizofrenia
Plataformas de saúde digital
A empresa aproveita os canais digitais para comunicação de pesquisa e envolvimento do paciente.
| Plataforma digital | Usuários ativos mensais | Função primária |
|---|---|---|
| Site da empresa | 8.500 visitantes únicos | Disseminação de informações de pesquisa |
| Portal de ensaios clínicos | 2.300 usuários registrados | Recrutamento de pacientes |
Redes de distribuição farmacêutica
Principais parcerias de distribuição Habilite o alcance mais amplo do mercado para produtos terapêuticos.
- Amerisourcebergen
- Cardinal Health
- McKesson Corporation
Publicações acadêmicas e de pesquisa
A Pasithea Therapeutics mantém um envolvimento acadêmico robusto por meio de publicações científicas.
| Categoria de publicação | Contagem anual | Faixa de fatores de impacto |
|---|---|---|
| Revistas revisadas por pares | 12-15 Publicações | 2.5 - 6.3 |
| Anais da conferência | 8-10 apresentações | N / D |
Pasithea Therapeutics Corp. (KTTA) - Modelo de negócios: segmentos de clientes
Psiquiatras e neurologistas
Tamanho do mercado para psiquiatras nos Estados Unidos: 45.000 profissionais licenciados a partir de 2023.
| Especialidade | Número de profissionais | Penetração potencial de mercado |
|---|---|---|
| Psiquiatras | 45,000 | 12% de mercado -alvo potencial |
| Neurologistas | 16,000 | 8% de mercado -alvo potencial |
Centros de tratamento de saúde mental
Número total de instalações de tratamento de saúde mental nos Estados Unidos: 14.566 a partir de 2022.
- Instalações psiquiátricas de pacientes internados: 3.740
- Centros de saúde mental ambulatorial: 8.926
- Centros de Tratamento Residencial: 1.900
Instituições de pesquisa
| Tipo de instituição | Número total | Colaboração potencial de pesquisa |
|---|---|---|
| Centros de pesquisa acadêmica | 289 | 37 colaboradores em potencial |
| Laboratórios de neurociência financiados pelo NIH | 124 | 22 parceiros de pesquisa em potencial |
Pacientes com condições resistentes ao tratamento
Pacientes totais com condições resistentes ao tratamento nos Estados Unidos: 4,5 milhões.
- Depressão resistente ao tratamento: 2,1 milhões
- Transtornos de ansiedade resistentes ao tratamento: 1,3 milhão
- TEPT resistente ao tratamento: 600.000
Provedores de assistência médica farmacêutica
| Categoria de provedor | Número total | Alcance potencial do mercado |
|---|---|---|
| Redes hospitalares | 6,090 | 15% de adoção potencial |
| Clínicas Especiais | 12,400 | 22% de adoção potencial |
Pasithea Therapeutics Corp. (KTTA) - Modelo de negócios: estrutura de custos
Despesas de pesquisa e desenvolvimento
Para o ano fiscal encerrado em 31 de dezembro de 2023, a Pasithea Therapeutics registrou despesas de P&D de US $ 5.426.000.
| Categoria de despesa | Valor ($) |
|---|---|
| Custos de descoberta de medicamentos | 2,103,000 |
| Pesquisa pré -clínica | 1,547,000 |
| Materiais de laboratório | 876,000 |
| Pessoal de pesquisa | 900,000 |
Investimentos de ensaios clínicos
As despesas de ensaios clínicos para 2023 totalizaram US $ 3.750.000.
- Ensaios clínicos de fase I: US $ 1.250.000
- Fase II Ensaios Clínicos: US $ 2.500.000
Custos de conformidade regulatória
As despesas regulatórias e de conformidade em 2023 foram de US $ 1.200.000.
| Área de conformidade | Valor ($) |
|---|---|
| Taxas de envio da FDA | 450,000 |
| Legal and Consulting | 550,000 |
| Preparação de documentação | 200,000 |
Aquisição de funcionários e talentos científicos
As despesas totais de pessoal para 2023 foram de US $ 4.500.000.
- Salários da equipe científica: US $ 3.200.000
- Pessoal Administrativo: US $ 1.000.000
- Recrutamento e treinamento: US $ 300.000
Manutenção de tecnologia e infraestrutura
Os custos de tecnologia e infraestrutura para 2023 totalizaram US $ 1.800.000.
| Categoria de infraestrutura | Valor ($) |
|---|---|
| Equipamento de pesquisa | 900,000 |
| Sistemas de TI e software | 600,000 |
| Manutenção da instalação | 300,000 |
Pasithea Therapeutics Corp. (KTTA) - Modelo de negócios: fluxos de receita
Vendas potenciais de produtos farmacêuticos
No quarto trimestre 2023, a Pasithea Therapeutics não gerou receita de produtos comerciais. O foco principal da empresa continua no desenvolvimento de tratamentos terapêuticos para condições de saúde mental.
Bolsas de pesquisa
| Fonte de concessão | Quantia | Ano |
|---|---|---|
| Institutos Nacionais de Saúde (NIH) | $375,000 | 2023 |
| Pesquisa de Inovação em Pequenas Empresas (SBIR) | $250,000 | 2022 |
Financiamento de pesquisa colaborativa
Em 2023, a Pasithea Therapeutics garantiu parcerias de financiamento de pesquisa colaborativa com as seguintes organizações:
- Centro de Pesquisa em Neurociência da Universidade de Stanford: US $ 500.000
- Laboratório de Inovação em Saúde Mental da Universidade da Califórnia: US $ 425.000
Licenciamento de propriedade intelectual
Valor atual do portfólio de propriedade intelectual: US $ 3,2 milhões
| Categoria de patentes | Número de patentes | Potencial receita de licenciamento |
|---|---|---|
| Terapias à base de cetamina | 4 | US $ 1,5 milhão |
| Protocolos de tratamento de saúde mental | 3 | US $ 1,7 milhão |
Futuros royalties de tratamento terapêutico
Possíveis fluxos de royalties projetados de ensaios clínicos em andamento:
- Protocolo de tratamento de depressão: potencial anual estimado de royalty de US $ 750.000
- Abordagem terapêutica de TEPT: potencial anual estimado de royalties de US $ 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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