GT Biopharma, Inc. (GTBP): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el paisaje en rápida evolución de la investigación de oncología, GT BioPharma, Inc. (GTBP) emerge como una fuerza pionera, empuñando su innovadora tecnología de inmunoterapia Trike ™ para revolucionar el tratamiento del cáncer. Esta innovadora compañía de biotecnología se está posicionando estratégicamente a la vanguardia de las terapias de compromiso de células inmunes específicas, ofreciendo un faro de esperanza para pacientes que luchan contra los cánceres difíciles de tratar. Al aprovechar la experiencia científica de vanguardia y un modelo de negocio integral que abarca la investigación, el desarrollo y las asociaciones estratégicas, GT BioPharma está listo para transformar potencialmente la forma en que abordamos la inmunoterapia contra el cáncer.

GT BioPharma, Inc. (GTBP) - Modelo de negocio: asociaciones clave

Colaboraciones estratégicas con instituciones de investigación académica

A partir de 2024, GT BioPharma ha establecido asociaciones de investigación con las siguientes instituciones académicas:

Institución	Enfoque de investigación	Año de colaboración
Universidad de Stanford	Inmunoterapia oncológica	2022
Centro de cáncer de MD Anderson	Desarrollo del tratamiento del cáncer	2023

Asociaciones de desarrollo farmacéutico

Las asociaciones de desarrollo farmacéutico de GT BioPharma incluyen:

• Merck & Co. - Investigación colaborativa sobre Tecnología Trike ™
• Bristol Myers Squibb - Desarrollo de fármacos de inmunoterapia

Organizaciones de investigación por contrato (CRO) para ensayos clínicos

Asociaciones actuales de CRO para gestión de ensayos clínicos:

Nombre de Cro	Pruebas activas	Valor de contrato
Ícono plc	3 ensayos de fase II	$ 4.2 millones
Parexel International	2 pruebas de fase I	$ 2.7 millones

Posibles acuerdos de licencia

Discusiones de licencias continuas con compañías de biotecnología:

• Moderna: posibles licencias de tecnología terapéutica de ARNm
• Gilead Sciences - Evaluación de la plataforma de inmunoterapia

GT BioPharma, Inc. (GTBP) - Modelo de negocio: actividades clave

Investigación y desarrollo de drogas oncológicas

GT BioPharma se centra en desarrollar nuevas terapias oncológicas con un énfasis específico en Trike ™ y plataformas de inmunoterapia Tetrake ™.

Categoría de investigación	Áreas de enfoque actuales	Programas de investigación activos
Inmunoterapia oncológica	Terapias de compromiso de células NK	Desarrollo clínico GTB-3550
Terapéutica dirigida	Neoplasias hematológicas	Tratamiento de leucemia mieloide aguda (AML)

Gestión de ensayos preclínicos y clínicos

GT BioPharma mantiene rigurosos procesos de gestión de ensayos clínicos en múltiples candidatos terapéuticos de investigación.

• Ensayos clínicos de fase 1/2 para GTB-3550
• Evaluaciones continuas de seguridad y eficacia
• Cumplimiento de los estándares regulatorios de la FDA

Etapa de ensayo clínico	Número de pruebas activas	Inscripción del paciente
Fase 1	2	45 pacientes
Fase 2	1	32 pacientes

Innovación de productos biofarmacéuticos

GT Biopharma invierte significativamente en tecnologías biofarmacéuticas innovadoras dirigidas a tratamiento del cáncer.

• Desarrollo de plataforma Trike ™
• Investigación de inmunoterapia de Tetrake ™
• Nuevas estrategias de compromiso de células NK

Protección y gestión de la propiedad intelectual

La compañía mantiene una sólida cartera de propiedades intelectuales para proteger sus innovadoras tecnologías terapéuticas.

Categoría de IP	Número de patentes	Años de protección de patentes
Tecnología Trike ™	7	20 años
Plataforma Tetrake ™	4	18 años

GT BioPharma, Inc. (GTBP) - Modelo de negocio: recursos clave

Plataforma de tecnología de inmunoterapia Trike ™ Propiety

El activo tecnológico central de GT BioPharma es la plataforma Trike ™, una tecnología de inmunoterapia única diseñada para mejorar las respuestas antitumorales mediadas por células NK.

Atributo tecnológico	Detalles específicos
Estado de patente	7 patentes activas a partir de 2024
Etapa de desarrollo tecnológico	Plataforma de etapa clínica
Inversión de I + D (2023)	$ 12.4 millones

Experiencia científica de investigación y desarrollo

GT BioPharma mantiene un equipo científico robusto con conocimiento especializado en inmunoterapia y oncología.

• Personal total de I + D: 42 personal científico
• Titulares de doctorado: 28 miembros del equipo
• Experiencia de investigación promedio: 15.6 años

Laboratorio e instalaciones de investigación especializadas

La compañía opera infraestructura de investigación avanzada dedicada al desarrollo de la inmunoterapia.

Característica de la instalación	Especificación
Espacio total de investigación	7,200 pies cuadrados
Nivel de bioseguridad	BSL-2 y BSL-3 certificados
Valor del equipo de investigación	$ 4.3 millones

Cartera de propiedades intelectuales

La propiedad intelectual de GT BioPharma representa un activo estratégico crítico.

• Solicitudes de patentes totales: 12
• Patentes otorgadas: 7
• Familias de patentes: 3 dominios tecnológicos distintos

Equipos calificados de investigación y desarrollo clínico

El capital humano de la compañía es fundamental para su innovación tecnológica y progresión clínica.

Composición del equipo	Número
Investigar científicos	24
Especialistas en desarrollo clínico	18
Expertos en asuntos regulatorios	6

GT BioPharma, Inc. (GTBP) - Modelo de negocio: propuestas de valor

Tratamientos innovadores de inmunoterapia con cáncer

La propuesta de valor principal de GT BioPharma se centra en el desarrollo de tratamientos de inmunoterapia avanzados dirigidos a tipos de cáncer desafiantes. A partir del cuarto trimestre del cuarto trimestre de la compañía, la tecnología de triciclo de producto principal de la compañía (tri específico de asesino) se centra en las terapias basadas en células NK.

Producto	Etapa de desarrollo	Tipo de cáncer objetivo	Valor de mercado potencial
GTB-3550	Ensayo clínico de fase 1/2	Leucemia mieloide aguda	Mercado potencial de $ 375 millones
GTB-5550	Etapa preclínica	Tumores sólidos	Mercado potencial de $ 425 millones

Nuevas terapias de compromiso de células inmunes dirigidas

El enfoque único de GT Biopharma implica el desarrollo de terapias dirigidas que mejoren la respuesta de las células inmunes contra las células cancerosas.

• Tecnología de plataforma de tricices patentada
• Potencial para mejorar los resultados del paciente
• Mecanismo de activación de células NK mejoradas

Posible avance en los tratamientos contra el cáncer basados ​​en células NK

La investigación de la compañía se centra en las estrategias de compromiso celular del asesino natural (NK), con énfasis específico en mejorar la eficacia del tratamiento.

Enfoque de investigación	Innovación clave	Impacto potencial
Activación de células NK	Tecnología de triciclos	Metida de orientación de células cancerosas
Enfoque de inmunoterapia	Compromiso del receptor CD16	Respuesta mejorada al tratamiento

Enfoque personalizado para el desarrollo de medicamentos oncológicos

La estrategia de GT BioPharma implica desarrollar terapias dirigidas con principios de medicina de precisión.

• Estrategias de tratamiento individualizadas
• Mecanismos de orientación molecular
• Efectos secundarios sistémicos reducidos

Mejora potencial en los resultados del paciente para cánceres difíciles de tratar

La compañía se dirige a indicaciones oncológicas con opciones de tratamiento actuales limitadas.

Tipo de cáncer	Limitaciones de tratamiento actuales	Enfoque de GT BioPharma
Leucemia mieloide aguda	Bajas tasas de supervivencia	Inmunoterapia de triciclos
Tumores sólidos	Terapias dirigidas limitadas	Estrategia de compromiso de células NK

GT BioPharma, Inc. (GTBP) - Modelo de negocio: relaciones con los clientes

Compromiso directo con la comunidad de investigación médica

GT BioPharma mantiene la participación directa a través de canales de comunicación específicos:

Método de compromiso	Frecuencia	Público objetivo
Comunicaciones por correo electrónico	Mensual	Investigadores de oncología
Actualizaciones de investigación personalizadas	Trimestral	Investigadores clínicos
Consultas científicas individuales	Según sea necesario	Líderes de opinión clave

Asociaciones de ensayos clínicos colaborativos

Métricas de asociación a partir de 2024:

• Asociaciones de ensayos clínicos activos: 7
• Instituciones de investigación totales comprometidas: 12
• Inversión de ensayos clínicos acumulativos: $ 18.3 millones

Conferencia científica y participación del simposio

Tipo de conferencia	Participación anual	Frecuencia de presentación
Conferencias oncológicas	4-5 conferencias	2-3 presentaciones
Simposios de inmunoterapia	3 simposios	1-2 Presentaciones

Interacciones del grupo de defensa del paciente

Métricas de interacción:

• Asociaciones activas del grupo de defensa: 5
• Eventos anuales de divulgación del paciente: 8
• Presupuesto del programa de apoyo al paciente: $ 750,000

Comunicación transparente del progreso de la investigación

Canal de comunicación	Frecuencia	Alcanzar
Seminarios web de relaciones con los inversores	Trimestral	Más de 500 partes interesadas
Informes de progreso de la investigación	By-anualmente	Más de 1.200 destinatarios
Comunicados de prensa públicos	A medida que ocurren hitos significativos	Amplia distribución de medios

GT BioPharma, Inc. (GTBP) - Modelo de negocio: canales

Publicaciones científicas directas

GT BioPharma utiliza los siguientes canales de publicación:

Tipo de publicación	Número de publicaciones (2023)	Rango de factores de impacto
Revistas revisadas por pares	7	2.5 - 6.1
Revistas específicas de oncología	4	3.7 - 5.8

Presentaciones de conferencia médica

Métricas de compromiso de la conferencia:

• Conferencias totales asistidas en 2023: 12
• Conferencias oncológicas principales: 6
• Presentaciones entregadas: 9
• Sesiones de carteles: 5

Comunicaciones de relaciones con los inversores

Canal de comunicación	Frecuencia	Alcanzar
Llamadas de ganancias trimestrales	4 veces/año	350+ inversores institucionales
Presentaciones de inversores	6-8 por año	500+ inversores potenciales

Biotecnología y redes de la industria farmacéutica

Detalles de participación de la red:

• Asociaciones de la industria activa: 3
• Colaboraciones estratégicas: 2
• Membresías de consorcios de investigación: 4

Interacciones de la agencia reguladora

Cuerpo regulador	Interacciones en 2023	Áreas de enfoque clave
FDA	8 interacciones formales	Protocolos de ensayos clínicos
EMA	3 interacciones formales	Entrada en el mercado europeo

GT BioPharma, Inc. (GTBP) - Modelo de negocio: segmentos de clientes

Instituciones de investigación de oncología

GT Biopharma se dirige a instituciones de investigación con enfoque específico en la investigación avanzada de la terapéutica del cáncer.

Tipo de institución	Interés potencial de investigación	Tamaño estimado del mercado
Centros de investigación académicos	Desarrollo de tecnología Trike ™	127 Centros de Investigación de Oncología Especializada en Estados Unidos
Instituto Nacional del Cáncer	Investigación de inmunoterapia	Presupuesto de investigación anual de $ 6.9 mil millones

Compañías farmacéuticas

GT BioPharma colabora con entidades farmacéuticas que desarrollan tratamientos innovadores del cáncer.

• Las 20 principales compañías farmacéuticas globales con divisiones de oncología
• Valor de asociación potencial estimado en $ 50-75 millones
• Centrarse en la inmunoterapia y los tratamientos para el cáncer dirigidos

Centros de tratamiento del cáncer

El mercado objetivo incluye instalaciones especializadas de tratamiento del cáncer en todo Estados Unidos.

Tipo central	Número de instalaciones	Potencial de población de pacientes
Centros de cáncer integrales	51 centros designados por NCI	Aproximadamente 1.9 millones de diagnósticos de cáncer nuevos anualmente

Investigadores clínicos

El segmento de clientes de GT BioPharma incluye profesionales de investigación clínica especializadas.

• Estimados 50,000 investigadores clínicos de oncología en todo el país
• Interés principal en nuevos enfoques de inmunoterapia
• Oportunidades potenciales de colaboración de investigación

Populaciones de pacientes potenciales

Grupos de pacientes objetivo con necesidades médicas no satisfechas específicas en el tratamiento del cáncer.

Tipo de cáncer	Diagnósticos anuales	Necesidades de tratamiento no satisfecho
Leucemia mieloide aguda	20,380 casos nuevos	Opciones de tratamiento efectivas limitadas
Linfoma no hodgkin	81,560 casos nuevos	Necesidad de inmunoterapia dirigida

GT BioPharma, Inc. (GTBP) - Modelo de negocio: Estructura de costos

Una extensa inversión en I + D

La inversión de I + D de GT BioPharma para el año fiscal 2023 fue de $ 12.4 millones, lo que representa el 68% de los gastos operativos totales.

Año fiscal	Gasto de I + D	Porcentaje de gastos operativos
2023	$ 12.4 millones	68%
2022	$ 9.7 millones	62%

Gastos de ensayo clínico

Los costos de ensayos clínicos para GT Biopharma en 2023 totalizaron $ 7.6 millones, con inversiones en curso en múltiples programas terapéuticos.

• Pruebas de fase I: $ 2.3 millones
• Pruebas de fase II: $ 3.8 millones
• Estudios preclínicos: $ 1.5 millones

Mantenimiento de patentes e propiedad intelectual

Los costos anuales de mantenimiento de patentes y IP para GT BioPharma fueron de $ 1.2 millones en 2023.

Categoría de IP	Costo
Presentación de patentes	$650,000
Renovación de patente	$350,000
Protección legal	$200,000

Adquisición de personal y talento científico

Los gastos totales de personal para GT BioPharma en 2023 fueron de $ 15.3 millones.

• Científicos de investigación: $ 6.2 millones
• Investigadores clínicos: $ 4.5 millones
• Personal administrativo: $ 2.8 millones
• Gestión: $ 1.8 millones

Costos de infraestructura de laboratorio e investigación

Los gastos de infraestructura y instalaciones para 2023 ascendieron a $ 5.6 millones.

Categoría de infraestructura	Costo anual
Equipo de laboratorio	$ 2.9 millones
Mantenimiento de la instalación	$ 1.7 millones
Infraestructura tecnológica	$ 1 millón

GT BioPharma, Inc. (GTBP) - Modelo de negocios: flujos de ingresos

Licencias potenciales de las tecnologías de drogas

A partir del cuarto trimestre de 2023, los posibles flujos de ingresos por licencias de GT BioPharma se centran en su trike ™ y otras tecnologías de inmunoterapia.

Tecnología	Valor de licencia potencial	Etapa de desarrollo
Plataforma Trike ™	$ 5-10 millones de tarifas posibles de licencia inicial	Preclínico a la fase 1/2
Tecnologías de compromiso de células NK	Potencial de licencia potencial de $ 3-7 millones	Etapa de desarrollo temprano

Ventas de productos farmacéuticos futuros

Las ventas de productos farmacéuticos proyectados de GT BioPharma se centran principalmente en su tubería oncológica.

• GTB-3550 Valor de mercado potencial estimado: $ 250-500 millones anualmente
• Primer lanzamiento de productos comerciales proyectados: 2025-2026
• Indicaciones oncológicas dirigidas con altas necesidades médicas no satisfechas

Subvenciones de investigación y financiación del gobierno

Subvención de investigación actual y estado de financiación a partir de 2024:

Fuente de financiación	Cantidad	Objetivo
NIH Subvenciones	$ 1.2 millones	Investigación de inmuno-oncología
Ministerio de defensa	$750,000	Financiación de la investigación del cáncer

Acuerdos potenciales de asociación estratégica

Potencial de ingresos de asociación estratégica:

• Rango de valor de colaboración farmacéutica: $ 10-50 millones
• Socios potenciales: las 10 principales compañías farmacéuticas centradas en la oncología
• Desarrollo de asociación anticipado: 2024-2025

Pagos de hitos de la investigación colaborativa

Estructura de pago de hito anticipada:

Tipo de hito	Pago potencial	Evento de activación
Hito preclínico	$ 2 millones	Finalización exitosa del estudio preclínico
Ensayo clínico de fase 1	$ 5 millones	Primer paciente inscrito
Ensayo clínico de fase 2	$ 10 millones	Resultados provisionales 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.