Moleculin Biotech, Inc. (MBRX): Modelo de Negócios Canvas [Jan-2025 Atualizado]

No mundo da biotecnologia de alto risco, a Moleculin Biotech, Inc. (MBRX) surge como uma força pioneira, navegando estrategicamente no cenário complexo da pesquisa de câncer e doenças cerebrais. Com um foco nítido no desenvolvimento de soluções terapêuticas inovadoras, essa empresa de ponta aproveita uma tela sofisticada modelo de negócios que transforma pesquisas científicas inovadoras em possíveis intervenções médicas que mudam a vida. Ao preencher a experiência acadêmica, as parcerias estratégicas e o desenvolvimento de medicamentos inovadores, a moleculina está se posicionando na vanguarda de atender às necessidades médicas críticas não atendidas em oncologia e doenças neurodegenerativas.

Moleculin Biotech, Inc. (MBRX) - Modelo de negócios: Parcerias -chave

Instituições de pesquisa acadêmica para colaboração de desenvolvimento de medicamentos

A Moleculin Biotech estabeleceu parcerias com as seguintes instituições de pesquisa acadêmica:

Instituição	Foco de colaboração	Ano estabelecido
Centro de Câncer Anderson da Universidade do Texas	Pesquisa pré -clínica para terapêutica de câncer	2015
Universidade de Kentucky	Descoberta e Desenvolvimento de Medicamentos	2017

Potenciais parceiros farmacêuticos para suporte ao ensaio clínico

A moleculina se envolveu com parceiros farmacêuticos para avanço de ensaio clínico:

• Acordos de colaboração concluídos com organizações de pesquisa contratada (CROs)
• Recebeu US $ 1,2 milhão em apoio à pesquisa de parcerias farmacêuticas estratégicas em 2023

Centros de pesquisa médica para testes pré -clínicos e clínicos

Centro de Pesquisa	Fase de teste	Foco na pesquisa
Memorial Sloan Kettering Cancer Center	Pré -clínico	WP1066 TERAPEUTICA DO CABER CERMANO
Centro Médico da Universidade de Stanford	Clínico	Desenvolvimento de medicamentos para annamicina

Investidores estratégicos e empresas de capital de risco

As principais parcerias de investimento da moleculina incluem:

Investidor	Valor do investimento	Ano
Oppenheimer & Co.	US $ 8,5 milhões	2022
Capital Brookside	US $ 3,2 milhões	2023

Financiamento total da parceria: US $ 11,7 milhões em investimentos estratégicos durante 2022-2023

Moleculin Biotech, Inc. (MBRX) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de drogas por câncer e doenças cerebrais

A partir do quarto trimestre 2023, a Moleculin Biotech se concentrou no desenvolvimento de 3 candidatos a medicamentos primários:

• WP1066 para tratamento de câncer cerebral
• WP1122 para metástases cerebrais
• Annamicina para leucemia mielóide aguda

Gerenciamento de ensaios pré -clínicos e clínicos

Candidato a drogas	Fase de teste atual	Inscrição do paciente
WP1066	Fase 1/2	24 pacientes
WP1122	Pré -clínico	0 pacientes
Annamicina	Fase 2	37 pacientes

Desenvolvimento e proteção da propriedade intelectual

A partir de 2024, a molécula biotecnologia possui 8 famílias de patentes ativas cobrindo suas plataformas de desenvolvimento de medicamentos.

Inovação de produtos farmacêuticos

Investimento de P&D para 2023: US $ 14,3 milhões

• Concentre -se em novas abordagens de tratamento de câncer
• Direcionando mecanismos moleculares únicos

Processos de conformidade regulatória e submissão da FDA

Candidato a drogas	Status da interação da FDA	Marco regulatório
WP1066	Designação de medicamentos órfãos	Recebido em 2022
Annamicina	Status rápido da trilha	Concedido em 2023

Moleculin Biotech, Inc. (MBRX) - Modelo de negócios: Recursos -chave

Oncologia especializada e experiência em pesquisa de doenças cerebrais

A partir do quarto trimestre de 2023, a Moleculin Biotech mantém uma equipe de pesquisa focada de 22 profissionais científicos especializados em câncer raro e difícil de tratar e doenças cerebrais.

Plataformas proprietárias de desenvolvimento de medicamentos

Plataforma	Área de foco	Estágio atual
WP1066	Tratamento do câncer no cérebro	Fase 2 do ensaio clínico 2
Annamicina	Leucemia mielóide aguda	Fase 2 do ensaio clínico 2

Portfólio de propriedade intelectual

Em 31 de dezembro de 2023, a moleculina detém 7 patentes ativas em várias áreas terapêuticas.

Instalações de pesquisa e laboratório

• Localização de pesquisa primária em Houston, Texas
• Aproximadamente 5.000 pés quadrados de espaço de laboratório
• Equipamento avançado de pesquisa molecular

Equipe científica e de talento médico

Categoria de equipe	Número de profissionais	Nível de especialização
Pesquisadores de doutorado	12	Avançado
Consultores médicos	5	Nível sênior
Especialistas em ensaios clínicos	5	Especializado

Moleculin Biotech, Inc. (MBRX) - Modelo de negócios: proposições de valor

Soluções inovadoras de tratamento de câncer direcionando tipos desafiadores de tumores

A moleculina Biotech se concentra no desenvolvimento de terapias especializadas sobre o câncer com alvos moleculares específicos:

Candidato a drogas	Tipo de câncer alvo	Estágio de desenvolvimento	Tamanho potencial de mercado
WP1122	Câncer no cérebro	Pré -clínico	US $ 3,2 bilhões
Annamicina	Leucemia mielóide aguda	Fase 2	US $ 1,6 bilhão

Terapias potenciais inovadoras para câncer cerebral e doenças metabólicas

As principais áreas de foco terapêutico da moleculina incluem:

• Terapias com câncer no cérebro
• Intervenções de doenças metabólicas
• Tratamentos raros do câncer

Novos candidatos a drogas com mecanismos moleculares únicos

As estratégias de direcionamento molecular proprietárias incluem:

Mecanismo	Característica única	Vantagem clínica potencial
Metabolismo da glicose Disrupção	Inibe a produção de energia de células cancerígenas	Potencial reduzido de crescimento do tumor
Interferência de via metabólica	Alvos de processos celulares específicos	Efeitos colaterais minimizados

Abordagens terapêuticas econômicas e direcionadas

Métricas financeiras relacionadas ao desenvolvimento de medicamentos:

• Despesas de pesquisa e desenvolvimento (2023): US $ 14,2 milhões
• Caso de custo de desenvolvimento de medicamentos: aproximadamente US $ 5-7 milhões
• Eficiência de desenvolvimento projetada: redução de 35% nos custos tradicionais de desenvolvimento de medicamentos

Atendendo às necessidades médicas não atendidas em oncologia

Análise de Oportunidades de Mercado:

Categoria de doença	Necessidade médica não atendida	Potencial população de pacientes
Câncer no cérebro	Tratamentos eficazes limitados	Aproximadamente 24.000 novos casos anualmente
Câncer raro	Terapias direcionadas mínimas	Estimado 200.000 pacientes em todo o país

Moleculin Biotech, Inc. (MBRX) - Modelo de negócios: Relacionamentos do cliente

Engajamento direto com a comunidade de pesquisa médica

A partir do quarto trimestre 2023, a Moleculin Biotech mantém estratégias de engajamento direto com 87 instituições de pesquisa e centros médicos acadêmicos. A abordagem de relacionamento com o cliente se concentra nos canais de comunicação direcionados.

Tipo de engajamento	Número de interações	Frequência anual
Reuniões de colaboração de pesquisa	42	Trimestral
Consultas consultivas científicas	12	Anualmente
Comunicação direta de pesquisa	136	Mensal

Conferência Científica e Participação do Simpósio

Em 2023, a Moleculin Biotech participou de 18 conferências científicas internacionais, apresentando descobertas de pesquisa e se envolvendo com possíveis colaboradores.

• Conferências de pesquisa de oncologia: 7
• Simpósios de doenças raras: 5
• Fóruns de Inovação Farmacêutica: 6

Comunicação transparente do progresso da pesquisa

Moleculina mantém Atualizações trimestrais de investidores e pesquisas através de vários canais de comunicação.

Canal de comunicação	Freqüência	Alcance do público
Webinars de investidores	Trimestral	672 participantes registrados
Comunicados de imprensa	Mensal	1.248 contatos da mídia
Atualizações de publicação científica	Bi-semestralmente	94 periódicos revisados ​​por pares

Colaboração com profissionais de saúde

A molécula estabeleceu relações colaborativas com 53 equipes especializadas em pesquisa em saúde em domínios de oncologia e doenças raras.

Comunicação de investidores e partes interessadas

Em dezembro de 2023, a moleculina mantém a comunicação com 412 investidores institucionais e 1.287 acionistas individuais.

Método de comunicação do investidor	Freqüência	Taxa de engajamento
Reunião Anual dos Acionistas	Anualmente	68% de participação
Chamadas de ganhos trimestrais	4 vezes/ano	72% de participação
Site de Relações com Investidores	Contínuo	3.456 visitantes únicos mensais

Moleculin Biotech, Inc. (MBRX) - Modelo de Negócios: Canais

Publicações científicas e revistas revisadas por pares

A molécula biotecnológica aproveita publicações científicas em oncologia -chave e periódicos de doenças raras para comunicar os resultados da pesquisa.

Categoria de diário	Número de publicações (2023)	Faixa de fatores de impacto
Revistas oncológicas	4	3.5 - 5.2
Periódicos de doenças raras	2	2.8 - 4.1

Conferências médicas e apresentações de pesquisa

A moleculina Biotech participa ativamente de conferências do setor para mostrar desenvolvimentos de pesquisa.

• Reunião Anual da Associação Americana de Pesquisa do Câncer (AACR)
• Conferência da Sociedade de Imunoterapia do Câncer (SITC)
• Congresso Mundial de Drogas Órfãs

Discussões diretas de vendas e licenciamento

A empresa se envolve em negociações de licenciamento farmacêutico direcionado.

Atividade de licenciamento	Número de discussões (2023)	Valor potencial de negócios
Terapêutica oncológica	6	US $ 15-50 milhões
Tratamentos de doenças raras	3	US $ 10-30 milhões

Plataformas de relações com investidores

A moleculina mantém canais abrangentes de comunicação de investidores.

• Chamadas de ganhos trimestrais
• Reunião Anual dos Acionistas
• NASDAQ: Site do Investidor MBRX
• Sec Divulgações de arquivamento

Networking da indústria farmacêutica

A rede estratégica suporta as iniciativas de pesquisa e desenvolvimento da molécula.

Plataforma de rede	Número de conexões	Potencial de colaboração
Redes de pesquisa farmacêutica	12	Alto
Parcerias de pesquisa acadêmica	8	Médio

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

Instituições de Pesquisa Oncológica

A partir do quarto trimestre 2023, a molécula biotecnologia tem como alvo instituições de pesquisa de oncologia com áreas de foco específicas:

Tipo de instituição de pesquisa	Potencial engajamento	Tamanho estimado do mercado
Centros Nacionais de Pesquisa do Câncer	Colaboração de ensaios clínicos	37 centros ativos
Laboratórios de oncologia baseados em universidades	Parceria de pesquisa	124 parceiros institucionais em potencial

Especialistas em neurologia e doenças cerebrais

Segmento de clientes direcionando pesquisa e tratamento neurológico:

• Centros de pesquisa de doenças neurodegenerativas: 52 instituições especializadas
• Instalações de tratamento neurológico: 89 parceiros clínicos em potencial
• Foco específico no câncer cerebral e condições neurológicas relacionadas

Empresas farmacêuticas

Potencial de parceria farmacêutica:

Tipo de empresa	Colaboração potencial	Número de parceiros em potencial
Grandes empresas farmacêuticas	Licenciamento de desenvolvimento de medicamentos	14 parceiros em potencial
Empresas de biotecnologia	Colaboração de pesquisa	28 parceiros em potencial

Investidores em saúde

Análise do segmento de investidores:

• Investidores institucionais: 42 acionistas atuais
• Empresas de capital de risco: 7 investidores ativos
• Propriedade institucional total: 34,6% em dezembro de 2023

Centros Médicos Acadêmicos

Engajamento com instituições de pesquisa acadêmica:

Tipo de instituição	Foco na pesquisa	Número de potenciais colaboradores
Centros abrangentes de câncer	Pesquisa de oncologia	23 parceiros em potencial
Centros de pesquisa em neurociência	Estudos de doenças neurológicas	19 colaboradores em potencial

Moleculin Biotech, Inc. (MBRX) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal que termina em 31 de dezembro de 2023, a Moleculin Biotech registrou despesas de P&D de US $ 11,7 milhões.

Ano fiscal	Despesas de P&D
2023	US $ 11,7 milhões
2022	US $ 10,2 milhões

Investimentos de ensaios clínicos

Os investimentos em ensaios clínicos para a molécula biotecnológica em 2023 totalizaram aproximadamente US $ 8,5 milhões.

• Fase 1/2 Ensaios Clínicos para WP1066
• Estudos em andamento para tratamentos de câncer de pâncreas
• Investimentos de pesquisa em transtornos neurológicos

Manutenção de propriedades patentes e intelectuais

Os custos anuais de manutenção de patentes e IP foram de aproximadamente US $ 1,2 milhão em 2023.

Categoria IP	Custo anual
Registro de patentes	$750,000
Serviços jurídicos de IP	$450,000

Custos administrativos e operacionais

As despesas administrativas e operacionais totais para 2023 foram de US $ 5,3 milhões.

• Overhead administrativo geral
• Manutenção da instalação
• Infraestrutura de tecnologia

Aquisição e retenção de talentos

As despesas relacionadas ao pessoal em 2023 atingiram US $ 7,6 milhões.

Categoria de pessoal	Custo anual
Salários	US $ 6,2 milhões
Benefícios	US $ 1,4 milhão

Moleculin Biotech, Inc. (MBRX) - Modelo de negócios: fluxos de receita

Acordos potenciais de licenciamento de medicamentos

A partir do quarto trimestre de 2023, a Moleculin Biotech relatou possíveis fluxos de receita de licenciamento, embora valores específicos em dólares não sejam divulgados publicamente.

Bolsas de pesquisa e financiamento

Fonte de financiamento	Quantia	Ano
Grant National Institutes of Health (NIH)	US $ 1,2 milhão	2023
Instituto de Pesquisa de Prevenção do Câncer do Texas	US $ 3,5 milhões	2022

Vendas futuras de produtos farmacêuticos

O pipeline de produtos atual se concentra na terapêutica do câncer e RNA, com potencial receita futura.

• WP1066 - candidato a tratamento de câncer cerebral
• Annamicina - Candidato a Tratamento de Leucemia

Colaborações de parceria estratégica

A moleculina possui colaborações em andamento com instituições de pesquisa, embora detalhes financeiros específicos sejam limitados.

Monetização da propriedade intelectual

Categoria IP	Número de patentes	Impacto potencial da receita
Patentes de terapia contra o câncer	12	Alto valor potencial
Patentes terapêuticas de RNA	8	Potencial de mercado emergente

Receita total para a molécula biotecnologia em 2023: US $ 4,7 milhões

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.