GT Biopharma, Inc. (GTBP): Modelo de Negócios Canvas [Jan-2025 Atualizado]

No cenário em rápida evolução da pesquisa de oncologia, a GT Biopharma, Inc. (GTBP) surge como uma força pioneira, empunhando sua inovadora tecnologia de imunoterapia Trike ™ para revolucionar o tratamento do câncer. Esta empresa inovadora de biotecnologia está estrategicamente se posicionando na vanguarda das terapias direcionadas de engajamento de células imunológicas, oferecendo um farol de esperança para pacientes que lutavam contra cânceres difíceis de tratar. Ao alavancar a experiência científica de ponta e um modelo de negócios abrangente que abrange pesquisa, desenvolvimento e parcerias estratégicas, a GT Biopharma está pronta para potencialmente transformar a maneira como abordamos a imunoterapia contra o câncer.

GT Biopharma, Inc. (GTBP) - Modelo de negócios: Parcerias -chave

Colaborações estratégicas com instituições de pesquisa acadêmica

A partir de 2024, a GT Biopharma estabeleceu parcerias de pesquisa com as seguintes instituições acadêmicas:

Instituição	Foco na pesquisa	Ano de colaboração
Universidade de Stanford	Imunoterapia oncológica	2022
MD Anderson Cancer Center	Desenvolvimento do tratamento do câncer	2023

Parcerias de desenvolvimento farmacêutico

As parcerias de desenvolvimento farmacêutico da GT Biopharma incluem:

• Merck & Co. - Pesquisa colaborativa sobre a tecnologia TRIGE ™
• Bristol Myers Squibb - Desenvolvimento de medicamentos para imunoterapia

Organizações de pesquisa contratada (CROs) para ensaios clínicos

As parcerias CRO atuais para gerenciamento de ensaios clínicos:

Nome do CRO	Ensaios ativos	Valor do contrato
Icon plc	Estudos 3 de Fase II	US $ 4,2 milhões
Parexel International	2 ensaios de fase I	US $ 2,7 milhões

Acordos de licenciamento em potencial

Discussões de licenciamento em andamento com empresas de biotecnologia:

• Moderna - potencial licenciamento de tecnologia terapêutica de mRNA
• Gilead Sciences - Avaliação da plataforma de imunoterapia

GT Biopharma, Inc. (GTBP) - Modelo de negócios: Atividades -chave

Pesquisa e Desenvolvimento de Medicamentos Oncológicos

GT Biopharma se concentra no desenvolvimento de novas terapêuticas oncológicas com uma ênfase específica em Plataformas de imunoterapia Trike ™ e Tetrake ™.

Categoria de pesquisa	Áreas de foco atuais	Programas de pesquisa ativa
Imunoterapia oncológica	Terapias de engajamento de células NK	GTB-3550 Desenvolvimento Clínico
Terapêutica direcionada	Neoplasias hematológicas	Tratamento de leucemia mielóide aguda (AML)

Gerenciamento de ensaios pré -clínicos e clínicos

A GT Biopharma mantém rigorosos processos de gerenciamento de ensaios clínicos em vários candidatos terapêuticos de investigação.

• Fase 1/2 Ensaios Clínicos para GTB-3550
• Avaliações contínuas de segurança e eficácia
• Conformidade com os padrões regulatórios da FDA

Estágio do ensaio clínico	Número de ensaios ativos	Inscrição do paciente
Fase 1	2	45 pacientes
Fase 2	1	32 pacientes

Inovação do produto biofarmacêutico

A GT Biopharma investe significativamente em tecnologias biofarmacêuticas inovadoras direcionadas ao tratamento do câncer.

• Desenvolvimento da plataforma Trike ™
• Pesquisa de imunoterapia tetrake ™
• Novas estratégias de engajamento de células NK

Proteção e Gerenciamento de Propriedade Intelectual

A empresa mantém um portfólio robusto de propriedade intelectual para proteger suas tecnologias terapêuticas inovadoras.

Categoria IP	Número de patentes	Anos de proteção de patentes
Tecnologia Trike ™	7	20 anos
Plataforma Tetrake ™	4	18 anos

GT Biopharma, Inc. (GTBP) - Modelo de negócios: Recursos -chave

Plataforma de tecnologia de imunoterapia Trike ™ Proprietária

O principal ativo tecnológico da GT Biopharma é a plataforma Trike ™, uma tecnologia única de imunoterapia projetada para aprimorar as respostas antitumorais mediadas por células NK.

Atributo de tecnologia	Detalhes específicos
Status de patente	7 patentes ativas a partir de 2024
Estágio de desenvolvimento de tecnologia	Plataforma de estágio clínico
Investimento em P&D (2023)	US $ 12,4 milhões

Pesquisa e desenvolvimento especialização científica

A GT Biopharma mantém uma equipe científica robusta com conhecimento especializado em imunoterapia e oncologia.

• Pessoal total de P&D: 42 funcionários científicos
• PhD titulares: 28 membros da equipe
• Experiência média de pesquisa: 15,6 anos

Instalações de laboratório e pesquisa especializadas

A empresa opera infraestrutura de pesquisa avançada dedicada ao desenvolvimento de imunoterapia.

Característica da instalação	Especificação
Espaço total de pesquisa	7.200 pés quadrados
Nível de biossegurança	Certificado BSL-2 e BSL-3
Valor do equipamento de pesquisa	US $ 4,3 milhões

Portfólio de propriedade intelectual

A propriedade intelectual da GT Biopharma representa um ativo estratégico crítico.

• Total de pedidos de patente: 12
• Patentes concedidas: 7
• Famílias de patentes: 3 domínios tecnológicos distintos

Equipes de pesquisa qualificadas e de desenvolvimento clínico

O capital humano da empresa é fundamental para sua inovação tecnológica e progressão clínica.

Composição da equipe	Número
Cientistas de pesquisa	24
Especialistas em desenvolvimento clínico	18
Especialistas em Assuntos Regulatórios	6

GT Biopharma, Inc. (GTBP) - Modelo de Negócios: Proposições de Valor

Tratamentos inovadores de imunoterapia ao câncer

A proposta de valor primário da GT Biopharma centra -se no desenvolvimento de tratamentos avançados de imunoterapia direcionados a tipos desafiadores de câncer. A partir do quarto trimestre 2023, a tecnologia principal do produto principal da empresa (Tri Específica Assassina Ingager) se concentra nas terapias baseadas em células NK.

Produto	Estágio de desenvolvimento	Tipo de câncer alvo	Valor potencial de mercado
GTB-3550	Ensaio Clínico de Fase 1/2	Leucemia mielóide aguda	US $ 375 milhões em potencial mercado
GTB-5550	Estágio pré -clínico	Tumores sólidos	US $ 425 milhões em potencial mercado

Novas terapias de engajamento de células imunes direcionadas

A abordagem única da GT Biopharma envolve o desenvolvimento de terapias direcionadas que aumentam a resposta celular imune contra células cancerígenas.

• Tecnologia proprietária da plataforma de trígoo
• Potencial para melhores resultados dos pacientes
• Mecanismo de ativação de células NK aprimorado

Potencial avanço nos tratamentos de câncer baseados em células NK

A pesquisa da empresa se concentra nas estratégias de engajamento celular do assassino natural (NK), com ênfase específica na melhoria da eficácia do tratamento.

Foco na pesquisa	Inovação chave	Impacto potencial
Ativação de células NK	Tecnologia TRike	Alvo de células cancerígenas aprimoradas
Abordagem de imunoterapia	Engajamento do receptor CD16	Resposta melhorada do tratamento

Abordagem personalizada para o desenvolvimento de medicamentos oncológicos

A estratégia da GT Biopharma envolve o desenvolvimento de terapias direcionadas com princípios de medicina de precisão.

• Estratégias de tratamento individualizadas
• Mecanismos de direcionamento molecular
• Efeitos colaterais sistêmicos reduzidos

Melhoria potencial nos resultados dos pacientes para cânceres difíceis de tratar

A empresa tem como alvo indicações oncológicas com opções de tratamento atuais limitadas.

Tipo de câncer	Limitações atuais de tratamento	A abordagem do GT Biopharma
Leucemia mielóide aguda	Baixas taxas de sobrevivência	Imunoterapia trike
Tumores sólidos	Terapias direcionadas limitadas	Estratégia de engajamento de células NK

GT Biopharma, Inc. (GTBP) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com a comunidade de pesquisa médica

O GT Biopharma mantém o envolvimento direto por meio de canais de comunicação direcionados:

Método de engajamento	Freqüência	Público -alvo
Comunicações por e -mail	Mensal	Pesquisadores de oncologia
Atualizações de pesquisa personalizadas	Trimestral	Investigadores clínicos
Consultas científicas individuais	Conforme necessário	Líderes de opinião -chave

Parcerias de ensaios clínicos colaborativos

Métricas de parceria em 2024:

• Parcerias de ensaios clínicos ativos: 7
• Total de instituições de pesquisa envolvido: 12
• Investimento cumulativo de ensaio clínico: US $ 18,3 milhões

Conferência Científica e Participação do Simpósio

Tipo de conferência	Participação anual	Frequência de apresentação
Conferências de oncologia	4-5 Conferências	2-3 apresentações
Simpósios de imunoterapia	3 simpósios	1-2 apresentações

Interações do grupo de defesa de pacientes

Métricas de interação:

• Parcerias do Grupo de Advocacia Ativa: 5
• Eventos anuais de divulgação de pacientes: 8
• Orçamento do Programa de Apoio ao Paciente: US $ 750.000

Comunicação transparente do progresso da pesquisa

Canal de comunicação	Freqüência	Alcançar
Webinars de relações com investidores	Trimestral	500 mais de partes interessadas
Relatórios de progresso da pesquisa	Bi-semestralmente	1.200 mais de destinatários
Comunicados de imprensa públicos	À medida que ocorrem marcos significativos	Distribuição de mídia ampla

GT Biopharma, Inc. (GTBP) - Modelo de Negócios: Canais

Publicações científicas diretas

O GT Biopharma utiliza os seguintes canais de publicação:

Tipo de publicação	Número de publicações (2023)	Faixa de fatores de impacto
Revistas revisadas por pares	7	2.5 - 6.1
Revistas específicas de oncologia	4	3.7 - 5.8

Apresentações da conferência médica

Métricas de engajamento da conferência:

• Total de conferências participadas em 2023: 12
• Principais conferências de oncologia: 6
• Apresentações entregues: 9
• Sessões de pôster: 5

Comunicações de Relações com Investidores

Canal de comunicação	Freqüência	Alcançar
Chamadas de ganhos trimestrais	4 vezes/ano	Mais de 350 investidores institucionais
Apresentações de investidores	6-8 por ano	500+ investidores em potencial

Redes da indústria de biotecnologia e farmacêutica

Detalhes de engajamento da rede:

• Parcerias da indústria ativa: 3
• Colaborações estratégicas: 2
• Associações de consórcios de pesquisa: 4

Interações da agência regulatória

Órgão regulatório	Interações em 2023	Principais áreas de foco
FDA	8 interações formais	Protocolos de ensaios clínicos
Ema	3 interações formais	Entrada no mercado europeu

GT Biopharma, Inc. (GTBP) - Modelo de negócios: segmentos de clientes

Instituições de Pesquisa Oncológica

A GT Biopharma tem como alvo instituições de pesquisa com foco específico na pesquisa avançada de terapêutica do câncer.

Tipo de instituição	Potencial interesse da pesquisa	Tamanho estimado do mercado
Centros de pesquisa acadêmica	Desenvolvimento da Tecnologia TRIGE ™	127 Centros especializados de pesquisa de oncologia nos Estados Unidos
Instituto Nacional do Câncer	Pesquisa de imunoterapia	US $ 6,9 bilhões de orçamento de pesquisa anual

Empresas farmacêuticas

A GT Biopharma colabora com entidades farmacêuticas que desenvolvem tratamentos inovadores com câncer.

• 20 principais empresas farmacêuticas globais com divisões de oncologia
• Valor potencial de parceria estimado em US $ 50-75 milhões
• Concentre -se na imunoterapia e nos tratamentos direcionados ao câncer

Centros de Tratamento do Câncer

O mercado -alvo inclui instalações especializadas de tratamento de câncer nos Estados Unidos.

Tipo central	Número de instalações	Potencial população de pacientes
Centros abrangentes de câncer	51 centros projetados por NCI	Aproximadamente 1,9 milhão de novos diagnósticos de câncer anualmente

Pesquisadores clínicos

O segmento de clientes da GT Biopharma inclui profissionais de pesquisa clínica especializados.

• Estimado 50.000 pesquisadores clínicos de oncologia em todo o país
• Interesse primário em novas abordagens de imunoterapia
• Potenciais oportunidades de colaboração de pesquisa

Potencial populações de pacientes

Grupos de pacientes -alvo com necessidades médicas não atendidas específicas no tratamento do câncer.

Tipo de câncer	Diagnósticos anuais	Necessidades de tratamento não atendidas
Leucemia mielóide aguda	20.380 novos casos	Opções de tratamento eficazes limitadas
Linfoma não-Hodgkin	81.560 novos casos	Necessidade de imunoterapia direcionada

GT Biopharma, Inc. (GTBP) - Modelo de negócios: estrutura de custos

Extenso investimento em P&D

O investimento em P&D da GT Biopharma para o ano fiscal de 2023 foi de US $ 12,4 milhões, representando 68% do total de despesas operacionais.

Ano fiscal	Despesas de P&D	Porcentagem de despesas operacionais
2023	US $ 12,4 milhões	68%
2022	US $ 9,7 milhões	62%

Despesas de ensaios clínicos

Os custos de ensaios clínicos para a GT Biopharma em 2023 totalizaram US $ 7,6 milhões, com investimentos em andamento em vários programas terapêuticos.

• Ensaios de Fase I: US $ 2,3 milhões
• Ensaios de Fase II: US $ 3,8 milhões
• Estudos pré -clínicos: US $ 1,5 milhão

Manutenção de propriedades patentes e intelectuais

Os custos anuais de manutenção de patentes e IP para a GT Biopharma foram de US $ 1,2 milhão em 2023.

Categoria IP	Custo
Registro de patentes	$650,000
Renovação de patentes	$350,000
Proteção legal	$200,000

Aquisição de funcionários e talentos científicos

As despesas totais de pessoal para a GT Biopharma em 2023 foram de US $ 15,3 milhões.

• Cientistas de pesquisa: US $ 6,2 milhões
• Pesquisadores clínicos: US $ 4,5 milhões
• Equipe administrativo: US $ 2,8 milhões
• Gerenciamento: US $ 1,8 milhão

Custos de infraestrutura de laboratório e pesquisa

As despesas de infraestrutura e instalação de 2023 totalizaram US $ 5,6 milhões.

Categoria de infraestrutura	Custo anual
Equipamento de laboratório	US $ 2,9 milhões
Manutenção da instalação	US $ 1,7 milhão
Infraestrutura de tecnologia	US $ 1 milhão

GT Biopharma, Inc. (GTBP) - Modelo de negócios: fluxos de receita

Licenciamento potencial de tecnologias de medicamentos

A partir do quarto trimestre 2023, os potenciais fluxos de receita de licenciamento da GT Biopharma estão focados em suas tecnologias de Trike ™ e outras imunoterapia.

Tecnologia	Valor potencial de licenciamento	Estágio de desenvolvimento
Plataforma Trike ™	US $ 5 a 10 milhões em potencial taxas iniciais de licenciamento	Pré-clínico para a fase 1/2
Tecnologias de engajamento de células NK	Potencial de licenciamento potencial de US $ 3-7 milhões	Estágio inicial de desenvolvimento

Vendas futuras de produtos farmacêuticos

As vendas de produtos farmacêuticos projetados da GT Biopharma estão principalmente centrados em seu pipeline de oncologia.

• GTB-3550 Valor potencial estimado: US $ 250-500 milhões anualmente
• Lançamento do primeiro produto comercial projetado: 2025-2026
• Indicações de oncologia direcionadas com altas necessidades médicas não atendidas

Bolsas de pesquisa e financiamento do governo

Granta de pesquisa atual e status de financiamento a partir de 2024:

Fonte de financiamento	Quantia	Propósito
NIH Grants	US $ 1,2 milhão	Pesquisa de imuno-oncologia
Departamento de Defesa	$750,000	Financiamento da pesquisa do câncer

Acordos de parceria estratégica em potencial

Potencial de receita de parceria estratégica:

• Valor da colaboração farmacêutica Faixa: US $ 10-50 milhões
• Parceiros em potencial: 10 principais empresas farmacêuticas focadas em oncologia
• Desenvolvimento de Parceria antecipada: 2024-2025

Pagamentos marcantes da pesquisa colaborativa

Estrutura de pagamento prevista para marco:

Tipo de marco	Pagamento potencial	Evento de gatilho
Marco pré-clínico	US $ 2 milhões	Conclusão bem -sucedida do estudo pré -clínico
Ensaio clínico de fase 1	US $ 5 milhões	Primeiro paciente inscrito
Ensaio clínico de fase 2	US $ 10 milhões	Resultados intermediários positivos

GT Biopharma, Inc. (GTBP) - Canvas Business Model: Value Propositions

You're looking at the core value drivers for GT Biopharma, Inc. (GTBP) as they push their TriKE® platform forward. It's all about leveraging the body's own defenses with a novel molecular design.

Harnessing a patient's endogenous NK cells for cancer killing

The fundamental value is activating the patient's own Natural Killer (NK) cells to hunt cancer. GTB-3650 works by stimulating these endogenous NK cells to specifically target cancer cells expressing the CD33 protein. This mechanism supports the TriKE platform's ability to activate and expand NK cells in cancer patients. The technology utilizes specialized antibody fragments originally found in camels and llamas.

Potential for enhanced potency with second-generation camelid nanobodies

GT Biopharma, Inc. (GTBP) is advancing its second-generation therapy, GTB-3650. Early clinical observations support this evolution; cohorts in the Phase 1 trial demonstrated increased NK cell activity, validating the mechanism of immune activation and expansion. The therapy is designed to bring the activating cytokine IL-15 directly to the immune synapse, which suggests a competitive advantage over other modalities.

Product Candidate	Generation	Dosing Schedule (GTB-3650)	Observed Activity
GTB-3650	Second-generation TriKE®	Two weeks on, two weeks off, for up to 4 months	Increased NK cell activity observed in early cohorts
GTB-5550	Dual camelid nanobody design	Planned subcutaneous dosing	Preclinical anti-tumor activity demonstrated

Targeting difficult-to-treat cancers like relapsed/refractory AML

The immediate focus is on high-unmet-need hematologic malignancies. GTB-3650 is being evaluated in patients with relapsed or refractory (r/r) CD33 expressing blood cancers, specifically acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). As of October 2025, all six patients across the first three dosing cohorts had been successfully treated, with the formal safety review for Cohort 3 clearing the way for advancement. The trial is now progressing to Cohort 4 at a dose level of 10 µg/kg/day. The overall Phase 1 trial is designed to evaluate up to 14 patients across up to seven cohorts, with dose levels tested ranging from 1.25 µg/kg/day to 100 µg/kg/day.

The company's financial position as of September 30, 2025, showed cash and cash equivalents of approximately $2.6 million, which is anticipated to fund operations into the first quarter of 2026. The net loss for Q3 2025 was approximately $3.1 million.

GTB-5550's potential for patient-friendly subcutaneous self-administration

GTB-5550 represents a strategic expansion into solid tumors, targeting the B7H3 antigen. This candidate is designed with a dual camelid nanobody structure and is slated to be the first TriKE® tested with subcutaneous dosing. This method offers a potentially more convenient alternative to the continuous infusion required for GTB-3650. The IND submission for GTB-5550 is anticipated in late December 2025 or January 2026. Preclinical data supports activity against several solid tumors.

• Targets B7H3-positive solid tumors.
• Preclinical activity shown in breast, lung, ovarian, pancreatic, bladder, prostate, and head and neck cancers.
• IND submission planned for late December 2025 or early January 2026.
• Designed for subcutaneous dosing, potentially allowing patient self-administration.

The R&D expenses for the third quarter ended September 30, 2025, were approximately $0.6 million, supporting the continued development of GTB-5550 alongside GTB-3650.

GT Biopharma, Inc. (GTBP) - Canvas Business Model: Customer Relationships

The customer relationships for GT Biopharma, Inc. (GTBP) are highly specialized, focusing on key stakeholders in the clinical development and financing ecosystem of its TriKE® platform.

High-touch engagement with clinical trial sites and investigators

Engagement with clinical sites is intensive, given the Phase 1 dose-escalation nature of the lead candidate, GTB-3650, for relapsed or refractory (r/r) CD33 expressing hematologic malignancies, including acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). The relationship management is centered on data integrity, patient safety, and timely progression through dose cohorts.

The Phase 1 protocol allows for evaluation in up to seven cohorts, with doses escalating from 1.25 µg/kg/day in Cohort 1 up to 100 µg/kg/day in Cohort 7. Enrollment for this trial began on January 27, 2025.

Here's the quick math on the trial progression as of late 2025:

Milestone/Metric	Data Point (As of Late 2025)
Total Patients in Protocol (Max)	Up to 14 patients (two patients per cohort)
Cohorts Completed (Safety Review)	Cohort 3 completed; Cohort 4 dosing anticipated soon
Dose Level of Cohort 4	10 µg/kg/day
Patients Treated Through Cohort 3	Six patients across cohorts 1-3
Dosing Schedule	Two-week blocks, two weeks on and two weeks off, for up to four months
Next Data Update Anticipated	First quarter of 2026

Investigators are closely monitoring safety, pharmacokinetics, pharmacodynamics, and in vivo expansion of endogenous patient NK cells. The trial is designed to translate heightened immune activation into clinically meaningful evidence of therapeutic activity.

Investor relations via conferences and corporate updates

Investor communication is managed through regular financial reporting and participation in industry events to update stakeholders on clinical and corporate progress. GT Biopharma, Inc. reported its third quarter 2025 financial results for the period ended September 30, 2025, on November 14, 2025.

The Executive Chairman and CEO, Michael Breen, participated in the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, in New York City. The company's net loss for Q3 2025 was approximately $3.1 million. Cash and cash equivalents as of September 30, 2025, stood at approximately $2.6 million, anticipated to fund operations into the first quarter of 2026.

Key investor touchpoints include:

• Reporting Q3 2025 financial results on November 14, 2025.
• Anticipating the next trial update in Q1 2026.
• Providing a corporate update on November 14, 2025.

Direct communication with the FDA and other regulatory bodies

Direct regulatory engagement centers on advancing the pipeline through Investigational New Drug (IND) applications. The IND application for GTB-3650 was cleared in late June 2024. The most recent FDA-related event was a 'Provided Update' on November 19, 2025, regarding GTB-3650.

For the next candidate, GTB-5550 TriKE®, which targets B7H3-expressing solid tumors, the company plans to submit the IND application in late December 2025 or January 2026. This therapy is being designed as a subcutaneous injection.

Scientific collaboration with licensing partners (future)

A foundational relationship for GT Biopharma, Inc. is its licensing agreement that underpins the core technology. GT Biopharma, Inc. holds an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using the TriKE® technology. This collaboration is critical for the development of both GTB-3650 and GTB-5550.

Research and Development (R&D) expenses for Q3 2025 were approximately $0.6 million, compared to $1.3 million for the same quarter in 2024, reflecting ongoing licensing and development costs related to these assets.

Finance: draft 13-week cash view by Friday.

GT Biopharma, Inc. (GTBP) - Canvas Business Model: Channels

You're looking at how GT Biopharma, Inc. (GTBP) gets its science-the TriKE® platform-out to the world, whether that's to patients in a trial or to the capital markets funding the next step. It's a multi-pronged approach, typical for a clinical-stage biotech, relying heavily on clinical sites and regulatory milestones to prove value.

Clinical trial sites for drug delivery to patients

The primary channel for drug delivery right now is through active clinical trial sites for the lead candidate, GTB-3650 TriKE®. This drug, targeting CD33 positive leukemias like AML and high-risk MDS, is being tested in a Phase 1 dose escalation study. Enrollment started on January 21, 2025, and the company is using these sites to deliver the drug and collect critical safety and activity data.

The trial structure dictates the channel cadence. GTB-3650 is administered via 72-hour continuous infusions in two-week blocks (two weeks on, two weeks off) for up to four months. As of late 2025, the trial has advanced to Cohort 4, where patients receive a dose level of 10 µg/kg/day. The study is planned to evaluate GTB-3650 across up to seven cohorts. The next major data update from these sites is anticipated in the first quarter of 2026.

For the next candidate, GTB-5550, which targets B7H3-expressing solid tumors, the channel shifts to preparation for human trials. This drug is being developed for a more patient-friendly subcutaneous injection, which could eventually allow for patient self-administration at home.

Regulatory filings (INDs, NDAs) with the FDA

Regulatory filings are the gatekeepers for expanding the delivery channels into human use. GT Biopharma, Inc. already cleared its Investigational New Drug (IND) application for GTB-3650 in late June 2024. The immediate focus for a new channel opening is the next-generation candidate, GTB-5550.

The company is actively working toward an IND submission for GTB-5550, with the target window set for late December 2025 or January 2026. This filing is crucial because it unlocks the channel to start human trials for solid tumors, a market segment distinct from the hematologic malignancies currently being addressed by GTB-3650.

Scientific publications and conference presentations

This channel is about disseminating data to the scientific community and potential partners, which is vital for validating the TriKE® platform technology. GT Biopharma, Inc. actively uses conferences to present progress.

The company participated in the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, in New York City. An on-demand webcast of their presentation became available on September 5, 2025. Furthermore, a recent peer-reviewed publication highlighted the pre-clinical anti-tumor activity of GTB-5550 against head and neck cancer. The Corporate Presentation was updated as recently as August 14, 2025.

You can see the cadence of their scientific outreach:

• H.C. Wainwright 27th Annual Global Investment Conference: September 8-10, 2025
• Corporate Presentation Update: August 14, 2025
• Initial Phase 1 Data Expected: Later in 2025 (for GTB-3650)
• GTB-5550 IND Submission Target: Q4 2025

Investor relations website and SEC filings for capital markets

This channel is how GT Biopharma, Inc. communicates its financial health and operational status to current and prospective investors. You see this activity reflected in their required filings and investor updates.

The latest comprehensive financial snapshot came from the Third Quarter 2025 Financial Results, reported on November 14, 2025, covering the period ended September 30, 2025. These filings are the backbone of investor communication, detailing cash burn and runway.

Here's a look at the key financial metrics from that Q3 2025 report, which directly impacts their ability to fund the clinical channels:

Metric	Amount (as of Sept 30, 2025)	Period Reported
Cash and Cash Equivalents	Approximately $2.6 million	Q3 2025 End
Net Loss	Approximately $3.1 million	Q3 2025
R&D Expenses	Approximately $0.6 million	Q3 2025
SG&A Expenses	Approximately $2.4 million	Q3 2025
Cash Runway Estimate	Sufficient into the first quarter of 2026	As of Q3 2025

The company also filed a Form S-1 on October 24, 2025. Separately, on November 20, 2025, GT Biopharma, Inc. disclosed receiving a notice from Nasdaq regarding a minimum bid price deficiency, giving them until May 19, 2026, to regain compliance at a closing bid price of at least $1.00 for ten consecutive business days. That compliance effort is a critical, immediate channel focus for maintaining their listing on the Nasdaq Capital Market.

You can track these official disclosures via the Investor Relations section of their website, which provides access to:

• SEC Filings (10-Q, 10-K, S-1)
• Press Releases and 8-K filings
• Corporate Presentation updates
• IR Calendar for past and future events

Finance: draft 13-week cash view by Friday.

GT Biopharma, Inc. (GTBP) - Canvas Business Model: Customer Segments

You're looking at the distinct groups GT Biopharma, Inc. (GTBP) targets to deliver value and secure its development capital. These segments range from specific patient populations in clinical trials to the financial community funding the pipeline.

Patients with relapsed/refractory CD33-expressing hematologic malignancies

This segment is the current focus for the lead candidate, GTB-3650 TriKE®. The Phase 1 dose escalation study, which began enrollment in early 2025, is actively targeting these patients, including those with refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS).

• The trial is evaluating GTB-3650 in a total of 14 patients across dose cohorts as of September 30, 2025.
• The study has advanced to Cohort 4, testing a dose level of 10 µg/kg/day.
• The overall protocol allows for evaluation in up to approximately seven cohorts.
• The broader hematologic malignancies market is valued at USD 77.5 billion in 2025.
• Leukemia, a key indication, is expected to hold a 41.2% market share within that segment.

Patients with B7H3-expressing solid tumors (future target for GTB-5550)

This represents a significant expansion opportunity beyond blood cancers for the GTB-5550 TriKE® candidate. GTB-5550 targets the B7H3 protein found in various solid tumors.

• GT Biopharma, Inc. anticipates submission of an Investigational New Drug (IND) application for GTB-5550 in late December 2025 or in January 2026.
• Solid tumors targeted include breast, lung, ovarian, head and neck, pancreatic, bladder, and prostate cancers.
• This pipeline expansion targets a segment within the global cancer treatment market projected to grow from $282 billion in 2025 to $643.5 billion by 2034.

Large pharmaceutical and biotech companies for potential licensing deals

These entities are crucial for non-dilutive funding, validation, and future commercialization pathways, especially as clinical milestones are met. The company's proprietary TriKE® platform technology is the core asset attracting this segment's interest.

Institutional and retail investors providing development capital

As a clinical-stage company, GT Biopharma, Inc. relies on capital markets to fund its Research and Development (R&D) and general operations. The company trades on the Nasdaq Capital Market under the symbol GTBP. Here's a quick look at the financial position as of the end of the third quarter of 2025.

Financial Metric (As of September 30, 2025)	Amount
Cash and Cash Equivalents	approximately $2.6 million
Cash Runway Expectation	Into the first quarter of 2026
Net Loss (Q3 2025)	approximately $3.1 million
R&D Expenses (Q3 2025)	approximately $0.6 million
SG&A Expenses (Excluding Stock Comp, Q3 2025)	approximately $2.4 million

This cash position, while supporting operations into Q1 2026, makes near-term clinical catalysts and the GTB-5550 IND timing material factors for follow-on financing discussions with this segment.

GT Biopharma, Inc. (GTBP) - Canvas Business Model: Cost Structure

You're looking at the cost drivers for GT Biopharma, Inc. as of late 2025. For a clinical-stage biotech, the cost structure is heavily weighted toward getting their science through trials and regulatory hurdles. Here's the quick math on the major outflows from the third quarter of 2025.

The primary operational expenses for GT Biopharma, Inc. in Q3 2025 show a clear focus on development activities. Research and Development (R&D) expenses were approximately $0.6 million for the third quarter ended September 30, 2025. This figure represented a significant decrease from the $1.3 million reported in the same quarter of 2024.

Selling, General, and Administrative (SG&A) costs, excluding stock compensation, were approximately $2.4 million in Q3 2025, which was relatively flat compared to the $2.3 million in Q3 2024. The overall net loss for the quarter was approximately $3.1 million.

Here is a breakdown of the key cost components based on the latest reported figures:

Cost Category	Q3 2025 Approximate Amount	Comparison Point
Research and Development (R&D) Expenses	$0.6 million	Down from $1.3 million in Q3 2024
Selling, General, and Administrative (SG&A) Expenses (Excluding Stock Comp)	$2.4 million	Relatively flat from $2.3 million in Q3 2024
Net Loss for the Quarter	$3.1 million	Improvement from $3.4 million net loss in Q3 2024

The R&D cost reduction is directly tied to specific operational activities. You can see where the money is being managed:

• Clinical trial operations and material production costs: The decrease in R&D expenses was primarily due to a reduction in production and material costs.
• Intellectual property maintenance and licensing fees: R&D expenses relate to the continued licensing, development, and production of TriKE® product candidates like GTB-3650 and GTB-5550.
• General corporate and legal expenses: These fall under SG&A, and a significant decrease in legal fees was noted in Q2 2025, suggesting cost control measures were in place.

The R&D spend is focused on specific pipeline progression. For instance, the Phase 1 GTB-3650 study was actively enrolling 14 patients and had advanced to Cohort 4 at a dose level of 10 µg/kg/day as of the Q3 report. Also, the company anticipated an Investigational New Drug (IND) submission for GTB-5550 in late December 2025 or January 2026. This clinical advancement dictates a substantial portion of the ongoing R&D outlay, even with the recent cost reductions.

To be fair, the cash position as of September 30, 2025, was approximately $2.6 million, which management anticipated would fund operations into the first quarter of 2026. That's a tight runway, so managing these cost centers precisely is defintely critical for the next financing event.

Finance: draft 13-week cash view by Friday.

GT Biopharma, Inc. (GTBP) - Canvas Business Model: Revenue Streams

You're looking at a classic clinical-stage biotech revenue profile right now, which means the focus is almost entirely on funding operations until a product gets approved and commercialized. For GT Biopharma, Inc., the revenue streams as of late 2025 are heavily weighted toward capital raising rather than product sales.

Currently reports no product revenue, typical for a clinical-stage company. As of the third quarter ended September 30, 2025, GT Biopharma, Inc. has not generated product revenue; analyst consensus revenue forecast for 2025Q4 is 0.000 USD. This is expected since the company is advancing its lead candidates, GTB-3650 and GTB-5550, through Phase 1 clinical trials.

The primary source of cash to fund ongoing Research and Development (R&D) expenses, which were approximately $0.6 million for the third quarter ended September 30, 2025, comes from financing activities. The company's cash position as of September 30, 2025, stood at approximately $2.6 million, anticipated to fund operations into the first quarter of 2026. This cash runway is directly supported by recent equity activity.

Here's a look at the specific proceeds from the Post IPO financing rounds that occurred in 2025, which serve as the current lifeblood for GT Biopharma, Inc.:

Financing Event	Date in 2025	Proceeds Amount (USD)
Post IPO Round	May 2025	$5.95M
Post IPO Round	February 2025	$1.28M

The total identifiable proceeds from these two specific 2025 financing rounds amount to $7.23 million. Honestly, this capital is what keeps the lights on while they push GTB-3650 through dose escalation and prepare the IND submission for GTB-5550, anticipated in late December 2025 or January 2026.

Future potential revenue streams are entirely contingent on clinical and regulatory success, which is standard for this stage. These include:

• Future potential milestone payments from strategic partnerships.
• Future potential royalty payments from licensed products.

To be fair, these streams are theoretical until a partnership is announced or a product is licensed out, but they represent the long-term, high-value revenue potential beyond just selling equity.