Moleculin Biotech, Inc. (MBRX): Canvas del Modelo de Negocio [Actualizado en Ene-2025]

En el mundo de alto riesgo de la biotecnología, Moleculin Biotech, Inc. (MBRX) emerge como una fuerza pionera, navegando estratégicamente el complejo paisaje de la investigación del cáncer y las enfermedades cerebrales. Con un enfoque afilado en el desarrollo de soluciones terapéuticas innovadoras, esta empresa de vanguardia aprovecha un sofisticado lienzo de modelo de negocio que transforma la investigación científica innovadora en posibles intervenciones médicas que cambian la vida. Al unir la experiencia académica, las asociaciones estratégicas y el desarrollo de los fármacos innovadores, la moleculina se está posicionando a la vanguardia de abordar las necesidades médicas no satisfechas críticas en oncología y enfermedades neurodegenerativas.

Moleculin Biotech, Inc. (MBRX) - Modelo de negocio: asociaciones clave

Instituciones de investigación académica para la colaboración del desarrollo de fármacos

Moleculin Biotech ha establecido asociaciones con las siguientes instituciones de investigación académica:

Institución	Enfoque de colaboración	Año establecido
Centro de cáncer de Anderson de la Universidad de Texas	Investigación preclínica para la terapéutica del cáncer	2015
Universidad de Kentucky	Descubrimiento y desarrollo de drogas	2017

Potencios de socios farmacéuticos para el apoyo de ensayos clínicos

La moleculina se ha involucrado con socios farmacéuticos para el avance del ensayo clínico:

• Acuerdos de colaboración completados con organizaciones de investigación por contrato (CRO)
• Recibió $ 1.2 millones en apoyo de investigación de asociaciones farmacéuticas estratégicas en 2023

Centros de investigación médica para pruebas preclínicas y clínicas

Centro de investigación	Fase de prueba	Enfoque de investigación
Memorial Sloan Kettering Cancer Center	Preclínico	WP1066 Terapéutico del cáncer cerebral
Centro Médico de la Universidad de Stanford	Clínico	Desarrollo de medicamentos de annamicina

Inversores estratégicos y empresas de capital de riesgo

Las asociaciones de inversión clave de la moleculina incluyen:

Inversor	Monto de la inversión	Año
Oppenheimer & Co.	$ 8.5 millones	2022
Brookside Capital	$ 3.2 millones	2023

Financiación total de la asociación: $ 11.7 millones en inversiones estratégicas durante 2022-2023

Moleculin Biotech, Inc. (MBRX) - Modelo de negocio: actividades clave

Investigación y desarrollo de medicamentos para el cáncer y la enfermedad cerebral

A partir del cuarto trimestre de 2023, la biotecnología de la moleculina se ha centrado en desarrollar 3 candidatos de fármacos primarios:

• WP1066 para el tratamiento del cáncer cerebral
• WP1122 para metástasis cerebrales
• Annamicina para leucemia mieloide aguda

Gestión de ensayos preclínicos y clínicos

Candidato a la droga	Fase de prueba actual	Inscripción del paciente
WP1066	Fase 1/2	24 pacientes
WP1122	Preclínico	0 pacientes
Annamicina	Fase 2	37 pacientes

Desarrollo y protección de la propiedad intelectual

A partir de 2024, la biotecnología de la moleculina se mantiene 8 familias de patentes activas cubriendo sus plataformas de desarrollo de fármacos.

Innovación de productos farmacéuticos

Inversión de I + D para 2023: $ 14.3 millones

• Centrarse en nuevos enfoques de tratamiento del cáncer
• Dirigido a mecanismos moleculares únicos

Procesos de cumplimiento regulatorio y de presentación de la FDA

Candidato a la droga	Estado de interacción de la FDA	Hito regulatorio
WP1066	Designación de drogas huérfanas	Recibido en 2022
Annamicina	Estado de la vía rápida	Concedido en 2023

Moleculin Biotech, Inc. (MBRX) - Modelo de negocio: recursos clave

Oncología especializada y experiencia en investigación de enfermedades cerebrales

A partir del cuarto trimestre de 2023, Moleculin Biotech mantiene un equipo de investigación enfocado de 22 profesionales científicos que se especializan en cánceres raros y difíciles de tratar y enfermedades cerebrales.

Plataformas de desarrollo de fármacos patentados

Plataforma	Área de enfoque	Etapa actual
WP1066	Tratamiento del cáncer cerebral	Ensayo clínico Fase 2
Annamicina	Leucemia mieloide aguda	Ensayo clínico Fase 2

Cartera de propiedades intelectuales

Al 31 de diciembre de 2023, la moleculina posee 7 patentes activas a través de múltiples áreas terapéuticas.

Investigación e instalaciones de laboratorio

• Ubicación de investigación principal en Houston, Texas
• Aproximadamente 5,000 pies cuadrados de espacio de laboratorio
• Equipo de investigación molecular avanzado

Equipo de talento científico y médico

Categoría de equipo	Número de profesionales	Nivel de experiencia
Investigadores de doctorado	12	Avanzado
Asesores médicos	5	Nivel senior
Especialistas en ensayos clínicos	5	Especializado

Moleculin Biotech, Inc. (MBRX) - Modelo de negocio: propuestas de valor

Soluciones innovadoras de tratamiento del cáncer dirigido a tipos de tumores desafiantes

Moleculin Biotech se centra en el desarrollo de terapias de cáncer especializadas con objetivos moleculares específicos:

Candidato a la droga	Tipo de cáncer objetivo	Etapa de desarrollo	Tamaño potencial del mercado
WP1122	Cáncer cerebral	Preclínico	$ 3.2 mil millones
Annamicina	Leucemia mieloide aguda	Fase 2	$ 1.6 mil millones

Posibles terapias innovadoras para el cáncer cerebral y las enfermedades metabólicas

Las áreas de enfoque terapéutico clave de la moleculina incluyen:

• Terapias de cáncer cerebral
• Intervenciones de enfermedad metabólica
• Tratamientos raros contra el cáncer

Nuevos candidatos a medicamentos con mecanismos moleculares únicos

Las estrategias de orientación molecular patentada incluyen:

Mecanismo	Característica única	Ventaja clínica potencial
Interrupción del metabolismo de la glucosa	Inhibe la producción de energía de las células cancerosas	Potencial de crecimiento tumoral reducido
Interferencia de la ruta metabólica	Se dirige a procesos celulares específicos	Efectos secundarios minimizados

Enfoques terapéuticos rentables y específicos

Métricas financieras relacionadas con el desarrollo de fármacos:

• Gastos de investigación y desarrollo (2023): $ 14.2 millones
• Costo por ciclo de desarrollo de fármacos: aproximadamente $ 5-7 millones
• Eficiencia de desarrollo proyectado: reducción del 35% en los costos tradicionales de desarrollo de medicamentos

Abordar las necesidades médicas no satisfechas en oncología

Análisis de oportunidades de mercado:

Categoría de enfermedades	Necesidad médica insatisfecha	Potencial de población de pacientes
Cáncer cerebral	Tratamientos efectivos limitados	Aproximadamente 24,000 casos nuevos anualmente
Cánceres raros	Terapias dirigidas mínimas	Estimados 200,000 pacientes en todo el país

Moleculin Biotech, Inc. (MBRX) - Modelo de negocio: relaciones con los clientes

Compromiso directo con la comunidad de investigación médica

A partir del cuarto trimestre de 2023, Moleculin Biotech mantiene estrategias de participación directa con 87 instituciones de investigación y centros médicos académicos. Su enfoque de relación con el cliente se centra en los canales de comunicación específicos.

Tipo de compromiso	Número de interacciones	Frecuencia anual
Reuniones de colaboración de investigación	42	Trimestral
Consultas de la Junta Asesora Científica	12	Anualmente
Comunicación de investigación directa	136	Mensual

Conferencia científica y participación del simposio

En 2023, la biotecnología de moleculina participó en 18 conferencias científicas internacionales, presentando hallazgos de la investigación y participando con colaboradores potenciales.

• Conferencias de investigación oncológica: 7
• Simposios de enfermedades raras: 5
• Foros de innovación farmacéutica: 6

Comunicación transparente del progreso de la investigación

La moleculina mantiene Actualizaciones trimestrales de inversores e investigaciones a través de múltiples canales de comunicación.

Canal de comunicación	Frecuencia	Alcance de la audiencia
Seminarios web de inversores	Trimestral	672 participantes registrados
Comunicados de prensa	Mensual	1.248 contactos mediáticos
Actualizaciones de publicación científica	By-anualmente	94 revistas revisadas por pares

Colaboración con profesionales de la salud

La moleculina ha establecido relaciones colaborativas con 53 equipos especializados de investigación de salud en oncología y dominios de enfermedades raras.

Comunicación de inversores y partes interesadas

A diciembre de 2023, la moleculina mantiene la comunicación con 412 inversores institucionales y 1.287 accionistas individuales.

Método de comunicación de inversores	Frecuencia	Tasa de compromiso
Reunión anual de accionistas	Anualmente	68% de asistencia
Llamadas de ganancias trimestrales	4 veces/año	72% de participación
Sitio web de relaciones con los inversores	Continuo	3,456 visitantes únicos mensuales

Moleculin Biotech, Inc. (MBRX) - Modelo de negocio: canales

Publicaciones científicas y revistas revisadas por pares

La biotecnología de la moleculina aprovecha las publicaciones científicas en oncología clave y revistas de enfermedades raras para comunicar los resultados de la investigación.

Categoría de revista	Número de publicaciones (2023)	Rango de factores de impacto
Revistas de oncología	4	3.5 - 5.2
Revistas de enfermedades raras	2	2.8 - 4.1

Conferencias médicas y presentaciones de investigación

Moleculin Biotech participa activamente en conferencias de la industria para mostrar desarrollos de investigación.

• Reunión anual de la Asociación Americana de Investigación del Cáncer (AACR)
• Conferencia de la Sociedad para la Inmunoterapia del Cáncer (SITC)
• Congreso mundial de drogas huérfanas

Discusiones directas de ventas y licencias

La compañía se involucra en negociaciones de licencias farmacéuticas específicas.

Actividad de licencia	Número de discusiones (2023)	Valor potencial de acuerdo
Terapéutica oncológica	6	$ 15-50 millones
Tratamientos de enfermedades raras	3	$ 10-30 millones

Plataformas de relaciones con los inversores

La moleculina mantiene canales integrales de comunicación de inversores.

• Llamadas de ganancias trimestrales
• Reunión anual de accionistas
• NASDAQ: sitio web de inversores MBRX
• SEC que presenta divulgaciones

Redes de la industria farmacéutica

La red estratégica apoya las iniciativas de investigación y desarrollo de moleculina.

Plataforma de redes	Número de conexiones	Potencial de colaboración
Redes de investigación farmacéutica	12	Alto
Asociaciones de investigación académica	8	Medio

Moleculin Biotech, Inc. (MBRX) - Modelo de negocio: segmentos de clientes

Instituciones de investigación de oncología

A partir del cuarto trimestre de 2023, la biotecnología de moleculina se dirige a las instituciones de investigación de oncología con áreas de enfoque específicas:

Tipo de institución de investigación	Compromiso potencial	Tamaño estimado del mercado
Centros Nacionales de Investigación del Cáncer	Colaboración de ensayos clínicos	37 centros activos
Laboratorios de oncología universitarios	Asociación de investigación	124 Potencios Partidos Institucionales

Especialistas en neurología y enfermedades cerebrales

Segmento de clientes dirigido a la investigación y tratamiento neurológicos:

• Centros de investigación de enfermedades neurodegenerativas: 52 instituciones especializadas
• Instalaciones de tratamiento neurológico: 89 socios clínicos potenciales
• Enfoque específico en el cáncer cerebral y las afecciones neurológicas relacionadas

Compañías farmacéuticas

Potencial de asociación farmacéutica:

Tipo de empresa	Colaboración potencial	Número de socios potenciales
Grandes compañías farmacéuticas	Licencias de desarrollo de medicamentos	14 socios potenciales
Empresas de biotecnología	Colaboración de investigación	28 socios potenciales

Inversores de atención médica

Análisis de segmento de inversores:

• Inversores institucionales: 42 accionistas actuales
• Empresas de capital de riesgo: 7 inversores activos
• Propiedad institucional total: 34.6% a diciembre de 2023

Centros médicos académicos

Compromiso con instituciones de investigación académica:

Tipo de institución	Enfoque de investigación	Número de colaboradores potenciales
Centros de cáncer integrales	Investigación oncológica	23 socios potenciales
Centros de investigación de neurociencia	Estudios de enfermedad neurológica	19 colaboradores potenciales

Moleculin Biotech, Inc. (MBRX) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal que finaliza el 31 de diciembre de 2023, Moleculin Biotech reportó gastos de I + D de $ 11.7 millones.

Año fiscal	Gastos de I + D
2023	$ 11.7 millones
2022	$ 10.2 millones

Inversiones de ensayos clínicos

Las inversiones de ensayos clínicos para la biotecnología de moleculina en 2023 totalizaron aproximadamente $ 8,5 millones.

• Ensayos clínicos de fase 1/2 para WP1066
• Estudios en curso para tratamientos de cáncer de páncreas
• Inversiones de investigación de trastorno neurológico

Mantenimiento de patentes e propiedad intelectual

Los costos anuales de mantenimiento de patentes y IP fueron de aproximadamente $ 1.2 millones en 2023.

Categoría de IP	Costo anual
Presentación de patentes	$750,000
IP Servicios legales	$450,000

Costos administrativos y operativos

Los gastos administrativos y operativos totales para 2023 fueron de $ 5.3 millones.

• Sobrecarga administrativa general
• Mantenimiento de la instalación
• Infraestructura tecnológica

Adquisición y retención de talentos

Los gastos relacionados con el personal para 2023 alcanzaron los $ 7.6 millones.

Categoría de personal	Costo anual
Salarios	$ 6.2 millones
Beneficios	$ 1.4 millones

Moleculin Biotech, Inc. (MBRX) - Modelo de negocio: flujos de ingresos

Acuerdos potenciales de licencia de drogas

A partir del cuarto trimestre de 2023, la biotecnología de moleculina ha informado de posibles flujos de ingresos de licencias, aunque no se divulgan públicamente montos en dólares.

Subvenciones de investigación y financiación

Fuente de financiación	Cantidad	Año
Subvención de los Institutos Nacionales de Salud (NIH)	$ 1.2 millones	2023
Instituto de Investigación de Prevención del Cáncer de Texas	$ 3.5 millones	2022

Ventas de productos farmacéuticos futuros

La tubería de productos actual se centra en el cáncer y la terapéutica de ARN con posibles ingresos futuros.

• WP1066 - candidato al tratamiento del cáncer cerebral
• Annamycin - candidato a tratamiento de leucemia

Colaboraciones de asociación estratégica

La moleculina tiene colaboraciones continuas con las instituciones de investigación, aunque los detalles financieros específicos son limitados.

Monetización de la propiedad intelectual

Categoría de IP	Número de patentes	Impacto potencial de ingresos
Patentes de terapia del cáncer	12	Alto valor potencial
Patentes terapéuticas de ARN	8	Potencial del mercado emergente

Ingresos totales para la biotecnología de moleculina en 2023: $ 4.7 millones

Moleculin Biotech, Inc. (MBRX) - Canvas Business Model: Value Propositions

You're looking at the core offering for Moleculin Biotech, Inc. (MBRX) as of late 2025. The value proposition centers entirely on Annamycin, a drug candidate that needs to deliver on its promise to justify the capital burn-the company reported a net income loss of $25.39 million for Q3 2025, with cash reserves at $6.70 million as of September 30, 2025. This pipeline is the entire story right now.

Next-generation anthracycline (Annamycin) designed to avoid cardiotoxicity

Annamycin, also known by its non-proprietary name naxtarubicin, is engineered as a next-generation anthracycline. The key differentiator here is its design to avoid the cardiotoxicity common with currently prescribed anthracyclines. Preclinical data supports this, showing Annamycin maintained a favorable safety profile with little or no cardiotoxicity compared to standard anthracyclines in lab models. Furthermore, the company holds composition-of-matter patent protection for Annamycin through 2040, with a potential extension to 2045.

Potential treatment for multi-drug resistant Acute Myeloid Leukemia (AML)

The primary focus is on relapsed or refractory Acute Myeloid Leukemia (R/R AML). The drug is being tested in combination with cytarabine, a regimen referred to as AnnAraC, within the pivotal Phase 3 MIRACLE trial. Data from the preceding Phase 1B/2 (MB-106) trial shows significant potential compared to historical benchmarks for relapsed AML patients, whose typical Overall Survival (OS) is roughly 4-6 months.

Here's a snapshot of the Phase 1B/2 (MB-106) efficacy data:

Patient Population/Endpoint	Median Overall Survival (OS)	Rate/Count
Intent to Treat (ITT) Population (1L-7L)	9 months	(n=22)
2nd Line Efficacy Evaluable Population	12 months	(n=9)
Complete Remissions (CR)	15 months	(n=8)
CR/CRi Rate in Venetoclax-Refractory Subjects	60%	More than 4 times greater than historical rates
CR Rate in 2nd Line Subjects	N/A	50% (n=10)

Efficacy data in hard-to-treat Soft Tissue Sarcoma (STS) lung metastases

While the primary development is in AML, Annamycin also holds Orphan Drug Designation from the FDA for the treatment of STS lung mets. Although specific Phase 3 lung metastases data isn't detailed here, preclinical results presented in August 2025 showed strong activity against various liver metastases models, including colorectal liver metastases, where it halted metastatic spread and improved survival rates.

Addressing high unmet medical need in relapsed/refractory cancer populations

Moleculin Biotech, Inc. is targeting diseases with limited therapeutic options. The drug is specifically being developed for patients who have failed existing therapies, which is the definition of the R/R AML population in the MIRACLE trial. The potential to offer a 9-month median OS in the ITT population versus the typical 4-6 months highlights this unmet need fulfillment.

The MIRACLE Phase 3 trial design itself reflects the need for accelerated pathways:

• Target for first interim unblinding: 45 subjects.
• Expected completion of treatment for first 45 subjects: Q1 2026.
• First unblinding cohort split: 30 Annamycin subjects and 15 placebo subjects.
• Second unblinding expected: H1 2026.

Fast Track status promises accelerated regulatory review

The regulatory designations are a key part of the value proposition, signaling regulatory confidence in the drug's potential to address serious conditions.

• FDA Fast Track Status for R/R AML.
• FDA Orphan Drug Designation for R/R AML and STS lung mets.
• European Medicines Agency (EMA) Orphan Drug Designation for R/R AML.

This status, combined with the adaptive trial design, is intended to de-risk the development pathway toward a potential New Drug Application (NDA) submission as early as 2027.

Moleculin Biotech, Inc. (MBRX) - Canvas Business Model: Customer Relationships

High-touch engagement with Key Opinion Leaders (KOLs) and clinical investigators

• Phase 3 MIRACLE trial has active recruitment sites across five countries as of September 2025.
• Total selected trial sites worldwide reached 38 as of Q1 2025.
• The first planned interim unblinding target for the MIRACLE trial is 45 subjects.
• As of November 4, 2025, 60% of the target 45 subjects had consented.
• The first unblinding will cover 30 Annamycin subjects and 15 placebo subjects.
• The second unblinding is anticipated in H1 2026.
• Completed U.S. Phase 1B/2 trial (MB-107) for STS lung mets involved 32 subjects.

Direct communication with investors via earnings calls and virtual conferences

Moleculin Biotech, Inc. reported Q3 2025 earnings on November 13, 2025.

Metric	Value/Date
Q3 2025 Actual EPS	-$0.68
Q3 2025 Estimated EPS	-$0.22
Q3 2025 EPS Beat/(Miss) Percentage	Missed by 209.09%
Q3 2025 Actual EPS (Alternative Source)	-$0.13
Q3 2025 Estimated EPS (Alternative Source)	-$0.20
Trailing 12 Months (TTM) Earnings (ending Sep 30, 2025)	-$41.4M
Q3 2025 Earnings (ending Sep 30, 2025)	-$25.4M
Stock Decline Post Q1 2025 Call	5.54%
Stock Price Post Q1 2025 Call	$1.07
Stock Decline Over Past Year (as of Sept 2025)	84%
Stock Beta	1.64
Market Capitalization	Exceeded $14 million
Shares Outstanding	14.1 million

Regulatory relationship management with the FDA and EMA

• Annamycin has Orphan Drug Designation from the European Medicines Agency (EMA).
• The EMA approved the Clinical Trial Application (CTA) for AnnAraC across nine European Union countries.
• Annamycin holds FDA Fast Track Status for relapsed or refractory acute myeloid leukemia (R/R AML).
• The FDA agreed to a single pediatric study evaluating Annamycin/Cytarabine as a second line therapy for pediatric R/R AML patients as young as 6 months old.
• Moleculin Biotech received a Notice of Intent to Grant for a European patent for Annamycin, potentially solidifying EU exclusivity through 2040.

Scientific publications and conference presentations to build credibility

• Moleculin Biotech announced it would present at the 14th Annual Acute Leukemia Meeting in October 2025.
• Prior data showed Annamycin plus Ara-C achieved 60% CR/CRi in Venetoclax-resistant AML models, more than 4 times greater than published historical rates.
• Completed MB-107 trial showed median Overall Survival of 411 days and Progression-Free Survival of 63 days.
• In Phase 2 of MB-107, patients showed median PFS of 105 days and OS of 13.5 months.

Investor relations focused on pipeline milestones and cash runway

Cash on hand was $7.6 million as of June 30, 2025, believed sufficient to fund operations into Q4 2025.

• Cash on hand was $8 million at the end of Q1 2025, projected to fund operations into Q3 2025.
• The company anticipates needing an additional $15 million to sustain operations through Q1 2026.
• Warrant liability reached $20.6 million (GAAP) at the end of Q2 2025.
• Stockholder equity (GAAP) was $(7.2) million at the end of Q2 2025, compared to a $6.0 million surplus at the end of Q4 2024.
• The first data readout (n=45) was expected by the end of 2025.

Moleculin Biotech, Inc. (MBRX) - Canvas Business Model: Channels

You're looking at how Moleculin Biotech, Inc. (MBRX) gets its critical work-running trials, talking to regulators, and sharing results-out to the world as of late 2025. For a clinical-stage biotech, the channels aren't about selling widgets; they're about access, compliance, and communication.

Global network of clinical trial sites (US, EU, Ukraine, Georgia, Spain)

The primary channel for generating clinical evidence for Annamycin is the global network of clinical trial sites running the pivotal Phase 3 MIRACLE study. This multi-center approach diversifies risk and accelerates enrollment, which is key when you're targeting a data readout by the end of 2025.

As of the Q2 2025 update, there were 4 active sites screening subjects across Ukraine, Georgia, Spain, and the US. Moleculin Biotech, Inc. was aggressively expanding this footprint.

Here's the breakdown of the site expansion and geographic reach:

• Secured approval from the Regulation Agency for Medical and Pharmaceutical Activities (RAMPA) in Georgia.
• Received European Medicines Agency (EMA) approval, adding nine additional countries in the European Union (EU).
• By the end of September 2025, the plan was to have 20 sites recruiting across Ukraine, Spain, Georgia, Poland, Romania, Italy, Lithuania, and the United States.
• The overall Phase 3 MIRACLE trial is designed as a global approval trial, including sites in the US, Europe, and the Middle East.

The goal was to have recruited 45 subjects by the end of Q4 2025 for the first data unblinding.

Direct regulatory submissions to the FDA and European Medicines Agency (EMA)

Direct engagement with regulatory bodies is the only channel for drug approval. Moleculin Biotech, Inc. uses formal submissions, meetings, and feedback loops to guide its development pathway. This is where the de-risking of the development pathway happens, especially following the Phase 1B/2 study (MB-106) input from the FDA.

Key regulatory channel milestones include:

• Annamycin holds Fast Track Status from the FDA for treating relapsed or refractory acute myeloid leukemia (AML).
• Annamycin also has Orphan Drug Designation from the FDA for R/R AML and soft tissue sarcoma (STS) lung metastases.
• The EMA granted Orphan Drug Designation for R/R AML.
• Positive feedback was received from the FDA regarding the pediatric study plan for Annamycin in children with R/R AML.
• The EMA granted approval for the MIRACLE trial Clinical Trial Application (CTA).
• The company projects a rolling New Drug Application (NDA) submission by late 2028.

The EMA approval for the Phase 3 portion of the trial was contingent upon presenting nonclinical Good Laboratory Practice (GLP) study results, showing a clear data submission requirement channel.

Scientific and medical journals for publishing clinical data

Dissemination of data through peer-reviewed channels and scientific presentations validates the science. This channel builds credibility with clinicians, key opinion leaders, and future commercial partners. Moleculin Biotech, Inc. uses abstracts and formal presentations to communicate progress.

Recent activity in this channel includes:

Channel Type	Event/Publication Detail	Date/Timing	Data Point/Topic
Scientific Meeting Presentation	14th Annual Acute Leukemia Meeting (Madrid, Spain)	October 30-31, 2025	Presentation titled "L-Annamycin - Non-Cardiotoxic Anthracycline; MIRACLE Pivotal AML Study"
Abstract Publication	ASH Annual Meeting	Online publication, reference to Dec 7-10, 2024 meeting	Abstract: 'Annamycin, a non-cardiotoxic anthracycline, demonstrates unique organotropism and activity against Ara-C and Venetoclax resistant AML'
Investigator-Initiated Research	Research Agreement with UNC-Chapel Hill	Announced November 12, 2025	Evaluating Annamycin for pancreatic cancer using L-Annamycin and Free-Annamycin

The company also reported compelling topline data from the Phase 1B/2 soft tissue sarcoma lung metastases trial, showing a 13.5-month median overall survival.

Future pharmaceutical distribution channels via potential commercial partners

While Moleculin Biotech, Inc. is currently focused on clinical development, the channel for future commercial distribution relies on establishing relationships with larger pharmaceutical entities. This is a critical future channel, as the company needs external infrastructure for widespread market access post-approval. As of late 2025, Moleculin Biotech, Inc. reported $6.70 million in cash as of September 30, 2025, with a runway into Q4 2025, and is actively seeking an additional $7 million in funding. This financial reality underscores the necessity of securing a commercial partnership to fund later-stage activities and build out distribution.

The company's Q3 2025 net loss was $25.39 million, with operating costs of $5.90 million for the quarter. These figures highlight the capital intensity that necessitates a distribution partner channel for scale.

Investor platforms for financial disclosures and news distribution

The investor community is reached through mandatory SEC filings, press release distribution services like GlobeNewswire, and financial data platforms. These channels ensure compliance and provide the necessary transparency for capital raising.

Key metrics reported via these channels for Q3 2025 include:

• Reported EPS of -$0.68, beating the consensus estimate of -$0.22 by 209.09% (though still a miss against the actual estimate of -$0.22).
• Total assets stood at $19.45 million as of Q3 2025.
• The company announced it filed for a 1-for-25 reverse stock split on November 26, 2025.
• The company's market capitalization was $24.14M as of November 13, 2025.

The company uses platforms like GlobeNewswire for official announcements and is tracked on exchanges like NASDAQ. Finance: draft 13-week cash view by Friday.

Moleculin Biotech, Inc. (MBRX) - Canvas Business Model: Customer Segments

The customer segments for Moleculin Biotech, Inc. (MBRX) are defined by the specific medical needs addressed by their clinical pipeline, primarily Annamycin for relapsed/refractory Acute Myeloid Leukemia (AML) and other hard-to-treat cancers, as well as the financial entities supporting its late-stage development.

Oncologists and hematologists specializing in relapsed/refractory AML

This segment is targeted through the pivotal Phase 3 MIRACLE trial, which is evaluating Annamycin in combination with cytarabine (AnnAraC) for adult patients with relapsed or refractory AML (R/R AML) (Source 17, 18). The trial is designed with an adaptive structure, planning for an initial data unblinding upon enrollment and treatment of 45 subjects (Source 15, 16). The total planned enrollment for Part A is 75 to 90 subjects (Source 12, 17). Data from the prior MB-106 trial showed a Median Overall Survival (OS) of 9 months for the Intent to Treat (ITT) Population (n=22), which is significantly above the industry expectation of 4-6 months for relapsed AML patients (Source 6). Specifically, subjects achieving Complete Remission (CR) in that trial saw a Median OS of 15 months (n=8) (Source 6, 8).

Patients with hard-to-treat cancers, including AML and STS lung metastases

The primary patient group is R/R AML, with the MIRACLE trial aiming to have 45 subjects treated by the first quarter of 2026 for initial data review (Source 15). The trial is expanding globally, with active sites in the US, Spain, Ukraine, Georgia, and Romania, aiming for over 30 sites by year-end 2025 (Source 4, 16). Annamycin also holds Orphan Drug Designation for the treatment of soft tissue sarcoma (STS) lung metastases (Source 12, 15). The company reported a market capitalization of $15.71M as of November 14, 2025 (Source 2).

Institutional investors and specialist biotech funds

This group is crucial for financing late-stage development, with the company anticipating a need to raise approximately $15 million to extend operations into the first quarter of 2026 (Source 13). As of late 2025, Institutional Ownership stood at 15.52% (Source 1). In the last 24 months, institutional investors bought a total of 932,414 shares, representing approximately $22.61M in transactions (Source 1). Major institutional holders as of September 30, 2025, included Vanguard Group Inc. holding 9,597 thousand shares and Geode Capital Management, Llc holding 8,328 thousand shares (Source 3). The stock price as of November 28, 2025, was $0.27 / share (Source 5).

Regulatory agencies (FDA, EMA) as key gatekeepers to market access

The relationship with the FDA and EMA dictates the path to market. Annamycin has Fast Track Status and Orphan Drug Designation from the FDA for R/R AML (Source 11, 12). Furthermore, Annamycin has Orphan Drug Designation from the EMA for R/R AML (Source 11, 15). The EMA approved the company's Clinical Trial Application (CTA) to conduct the pivotal Phase 2B/3 study (Source 10). The FDA provided guidance that allowed for a reduction in the size of the Phase 3 pivotal trial protocol (Source 12). The FDA also agreed to a single pediatric study for Annamycin, recommending the inclusion of patients as young as 6 months old (Source 10).

Academic researchers for investigator-initiated trials

This segment is engaged through research collaborations that validate and expand the drug's potential. Moleculin Biotech announced Grant Funded Research evaluating Annamycin for the treatment of Pancreatic Cancer at UNC-Chapel Hill (Source 2). The company's patent protection for Annamycin extends through 2040, with a potential extension to 2045 (Source 11, 15).

Customer Segment	Key Metric/Data Point (Late 2025)	Associated Trial/Status
Oncologists/Hematologists	Target of 45 subjects for first data unblinding	MIRACLE Phase 3 AML Trial (Part A)
Patients (R/R AML)	Median OS of 9 months observed in ITT population (n=22) in prior trial	MB-106 Trial Data
Institutional Investors	Institutional Ownership: 15.52%	Stock Holdings (as of late 2025)
Institutional Investors	Shares bought in last 24 months: 932,414	Transaction Volume
Regulatory Agencies (FDA/EMA)	Orphan Drug Designation held from both FDA and EMA	Annamycin for R/R AML
Regulatory Agencies (FDA)	Recommended pediatric study inclusion as young as 6 months old	Pediatric Study Plan Guidance
Academic Researchers	Grant Funded Research initiated at UNC-Chapel Hill	Annamycin for Pancreatic Cancer

The company reported $7.7 million in cash and cash equivalents as of March 31, 2025 (Source 17). The GAAP EPS for Q2 2025 was $(0.49) (Source 18). Research & Development Expense for Q2 2025 was $3.60 million (Source 18).

Moleculin Biotech, Inc. (MBRX) - Canvas Business Model: Cost Structure

You're looking at the expenses that keep Moleculin Biotech, Inc. running as they push Annamycin through late-stage trials. For a clinical-stage biotech, the cost structure is almost entirely focused on R&D and keeping the lights on while waiting for revenue. Here's the quick math on what they spent in the second quarter of 2025.

The core operational costs for the three months ended June 30, 2025, show a focus on controlling overhead while advancing the pipeline. Research and development (R&D) expenses were reported at $3.6 million for Q2 2025. This was actually a decrease of $0.5 million compared to the same period in 2024, mainly due to a reduction in clinical trial activity during that specific quarter.

General and administrative (G&A) expenses remained relatively flat, coming in at approximately $2.1 million for the three months ended June 30, 2025. This covers the necessary corporate functions, executive salaries, and the overhead required to manage a public company.

The biggest single cost driver is the clinical development itself. The pivotal Phase 3 MIRACLE trial for Annamycin in relapsed or refractory acute myeloid leukemia (AML) is a massive undertaking. While Q2 2025 saw a temporary dip in R&D spend related to trial activity, the overall estimated cost for the Phase 3 trial is significant. Management previously estimated the total Phase 3 costs to be in the range of $60 million to $70 million. This trial is the primary focus, with the company aiming for the first interim data readout (n=45) before the end of 2025.

Because Moleculin Biotech, Inc. has no revenue, it must frequently access capital markets to fund these expenses, which introduces its own set of costs. You can see the expense of financing in the amounts raised and associated fees:

Financing Event/Cost Type	Reported Amount	Date Context
Gross Proceeds from Public Offering	Approximately $5.9 million	June 2025
Gross Proceeds from Registered Direct Offering	Approximately $3.5 million	February 2025
Potential Proceeds from ATM Agreement	Up to $6.5 million	July 2025
Loss on Issuance Recognized (June 2025 Offering)	$10.4 million	Q2 2025
Legal/Due Diligence Reimbursement (ATM Agreement)	Up to $50,000 (legal) plus $5,000 (due diligence) per period	July 2025

The costs associated with maintaining intellectual property are also a factor, though often less visible in quarterly P&L statements than R&D. Moleculin Biotech, Inc. has been actively securing its assets, evidenced by receiving a patent from the Australian Patent Office and a notice of allowance for a similar patent in Canada, which secures the IP for Annamycin. These activities necessitate ongoing legal expenditures for filings and maintenance fees globally.

The overall cash position reflects these costs; as of June 30, 2025, the company held $7.6 million in cash, which management guided was sufficient to fund planned operations only into the fourth quarter of 2025. This short runway means the cost structure is under constant pressure to secure the next financing round to cover the substantial clinical trial expenses.

• R&D expenses for Q2 2025: $3.6 million.
• G&A expenses for Q2 2025: $2.1 million.
• Total liabilities as of June 30, 2025: $28.8 million.
• Accumulated deficit as of June 30, 2025: $167.4 million.
• Warrant liability fair value as of June 30, 2025: $20.55 million.

Moleculin Biotech, Inc. (MBRX) - Canvas Business Model: Revenue Streams

Moleculin Biotech, Inc. is currently a clinical-stage pharmaceutical company, meaning product sales revenue is not yet generated.

The company's financial structure relies heavily on capital raises to fund its ongoing clinical development, as evidenced by recent financing activities.

Current Financial Position and Capital Inflow Data (as of late 2025):

Financial Metric/Event	Amount/Date
Cash and Cash Equivalents (as of June 30, 2025)	$7.6 million
Cash on Hand (End of Q3 2025)	$9.4 million
Anticipated Additional Funding Required (to sustain operations into Q1 2026)	$15 million
Gross Proceeds from June 2025 Offering	$5.9 million
Potential Proceeds from Warrant Exercises (from June 2025 offering)	Potential additional $17.8 million
Accumulated Deficit (as of June 30, 2025)	$167.4 million

Future revenue potential is entirely contingent upon the successful progression and ultimate commercialization of its drug candidates, primarily Annamycin.

Future potential revenue streams include:

• Future net sales of Annamycin post-approval for indications like Acute Myeloid Leukemia (AML) and Soft Tissue Sarcoma lung metastases (STS lung mets).
• Milestone payments from potential future licensing agreements tied to clinical or regulatory achievements for Annamycin.
• Royalties on net sales from any future commercial partners for Annamycin.

Intellectual property protection, which underpins future commercial value, is significant:

• Base patent term for Annamycin manufacturing methods extends until June 2040 in key jurisdictions, including the U.S. and Europe, subject to regulatory extensions.
• Orphan Drug Designation from the FDA and EMA provides potential for extended market exclusivity periods upon approval.

Non-dilutive funding sources provide operational support prior to product sales:

• Moleculin Biotech, Inc. has executed research agreements, such as the Research and Material Transfer Agreement with the University of North Carolina At Chapel Hill.
• Potential for future non-dilutive funding from government grants or research collaborations evaluating pipeline assets like Annamycin for Pancreatic Cancer.

Proceeds from equity financing and warrant exercises are a current, necessary source of funding:

• The June 2025 offering provided immediate capital, with a potential for further capital infusion upon warrant exercise.
• The company anticipates needing to raise approximately $15 million to cover operations through the initial data readout in early 2026.