Bio-Path Holdings, Inc. (BPTH): Modelo de negócios Canvas [Jan-2025 Atualizado]

No mundo de ponta da terapêutica do câncer, a Bio-Path Holdings, Inc. (BPTH) surge como uma empresa pioneira em biotecnologia que revoluciona estratégias de tratamento por meio de sua inovadora tecnologia de medicamentos antisense. Ao direcionar o câncer no nível genético com precisão sem precedentes, o BPTH está pronto para transformar a maneira como abordamos malignidades desafiadoras, oferecendo esperança por meio de pesquisas inovadoras que poderiam potencialmente oferecer terapias mais direcionadas e menos tóxicas para pacientes que enfrentam desafios oncológicos complexos.

Bio -Path Holdings, Inc. (BPTH) - Modelo de negócios: Parcerias -chave

Parcerias de pesquisa colaborativa com centros médicos acadêmicos

A partir de 2024, a Bio-Path Holdings mantém parcerias de pesquisa com os seguintes centros médicos acadêmicos:

Instituição	Foco na pesquisa	Status de colaboração
MD Anderson Cancer Center	Leucemia Therapeutics	Colaboração ativa
Centro Médico do Sudoeste da Universidade do Texas	Terapêutica de ácido nucleico	Contrato de pesquisa em andamento

Alianças estratégicas com instituições de pesquisa farmacêutica

As parcerias estratégicas de pesquisa farmacêutica incluem:

• Instituto de Câncer Dana-Farber
• Memorial Sloan Kettering Cancer Center
• Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Acordos de licenciamento em potencial

Possíveis acordos de licenciamento em 2024:

Empresa	Candidato a drogas	Status de licenciamento potencial
Terapêutica de precisão	BP-100 Lipossomal Grb2 Antisense	Estágio de negociação

Organizações de pesquisa contratada (CROs)

As parcerias CRO atuais para suporte ao ensaio clínico:

• Icon plc
• Iqvia Holdings Inc.
• Medpace Holdings

Orçamento total de apoio a ensaios clínicos para 2024: US $ 3,2 milhões

Bio -Path Holdings, Inc. (BPTH) - Modelo de negócios: Atividades -chave

Desenvolvendo terapêutica antisense do câncer

Holdings Bio-Path se concentra no desenvolvimento Terapêutica de câncer antisense Visando vias moleculares específicas. A partir de 2024, a empresa possui:

Plataforma terapêutica	Status de desenvolvimento	Indicação alvo
Prexigebersen (BP1001)	Estágio clínico	Leucemia mielóide aguda
BP1002	Pesquisa pré -clínica	Tumores sólidos

Condução de pesquisa pré -clínica e clínica

As atividades de pesquisa incluem:

• Estratégias de direcionamento molecular
• Projeto de oligonucleotídeo antisense
• Avaliação farmacológica

Gerenciando a descoberta de medicamentos e o pipeline de desenvolvimento

Estágio de pesquisa	Número de programas	Investimento (2024)
Pré -clínico	2	US $ 3,2 milhões
Ensaios clínicos	1	US $ 5,7 milhões

Buscando aprovações regulatórias

Atividades de envio regulatório para 2024:

• FDA Investigational New Drug (IND) Preparação de aplicação
• Desenvolvimento de protocolo de ensaios clínicos
• Documentação de conformidade regulatória

Bio -Path Holdings, Inc. (BPTH) - Modelo de negócios: Recursos -chave

Plataforma de Desenvolvimento de Medicamentos Antisense Proprietário

Holdings Bio-Path utiliza um Plataforma de tecnologia antisense DNABILLE® Para desenvolver tratamentos contra o câncer.

Característica da plataforma	Detalhes específicos
Tipo de tecnologia	Tecnologia antisense neutra de nanopartículas lipídicas
Status de patente	Múltiplas patentes emitidas protegendo a tecnologia da plataforma
Estágio de desenvolvimento	Oleoduto pré -clínico e clínico avançado

Portfólio de propriedade intelectual

A Bio-Path Holdings mantém um portfólio de propriedade intelectual de tecnologia de tratamento de câncer robusto.

• Número total de patentes emitidas: 15
• Proteção de patentes Cobrindo múltiplas abordagens terapêuticas de câncer
• Acordos de licenciamento exclusivos para inovações tecnológicas principais

Equipe de pesquisa científica

Composição da equipe de pesquisa	Número
Pessoal de pesquisa total	12 pesquisadores especializados de oncologia
Pesquisadores de nível de doutorado	8 funcionários científicos
Experiência de pesquisa combinada	Mais de 120 anos em pesquisa de oncologia

Instalações avançadas de laboratório e pesquisa

A Bio-Path Holdings opera infraestrutura de pesquisa especializada.

• Espaço total da instalação de pesquisa: 5.000 pés quadrados
• Laboratórios de cultura de células avançadas
• Equipamento de pesquisa de biologia molecular
• Recursos de pesquisa de nível 2 de biossegurança

Capital financeiro

Métrica financeira	2023 valor
Despesas totais de pesquisa e desenvolvimento	US $ 6,2 milhões
Caixa e equivalentes de dinheiro	US $ 3,8 milhões
Orçamento de pesquisa anual	US $ 5,5 milhões

Bio -Path Holdings, Inc. (BPTH) - Modelo de Negócios: Proposições de Valor

Tecnologia inovadora de medicamentos antisense direcionada ao tratamento do câncer

A proposta de valor-chave da Bio-Path Holdings se concentra Tecnologia antisense lipossômica (LBPD) para tratamento de câncer. A partir de 2024, a empresa desenvolveu:

• BP-1001: direcionando o gene Bcl-2 em vários tipos de câncer
• BP-1002: direcionando as mutações do oncogene Ras

Candidato a drogas	Tipo de câncer alvo	Estágio clínico
BP-1001	Leucemia mielóide aguda	Ensaio Clínico de Fase 1/2
BP-1002	Tumores sólidos	Desenvolvimento pré -clínico

Potencial para terapias de câncer mais precisas e menos tóxicas

A tecnologia da empresa demonstra:

• Toxicidade sistêmica reduzida em comparação com a quimioterapia tradicional
• Mecanismo aprimorado de entrega de medicamentos
• Potencial para direcionar mutações genéticas específicas

Característica da terapia	Quimioterapia tradicional	Tecnologia LBPD Bio-Path
Toxicidade sistêmica	Alto	Reduzido
Direcionamento de precisão	Limitado	Aprimorado

Abordagem única do silenciamento de genes em células cancerígenas

Proprietário de Bio-Path Tecnologia antisense lipossômica Ativa:

• Supressão de genes celulares diretos
• Efeitos minimizados fora do alvo
• Potencial para estratégias de tratamento personalizadas

Estratégias de tratamento personalizadas para desafiar os tipos de câncer

A pesquisa da empresa se concentra em:

• Leucemia mielóide aguda (AML)
• Câncer de pulmão
• Câncer de pâncreas
• Tumores sólidos metastáticos

Tipo de câncer	Necessidade médica não atendida	Abordagem biológica
Leucemia mielóide aguda	Opções de tratamento limitado	Segmentação do gene BP-1001
Tumores sólidos metastáticos	Altas taxas de mortalidade	Silenciamento de genes de precisão

Bio -Path Holdings, Inc. (BPTH) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com a comunidade de pesquisa médica

A partir do quarto trimestre 2023, as participações biográficas mantêm o engajamento direto por meio de:

Método de engajamento	Freqüência	Público -alvo
Reuniões do Conselho Consultivo Científico	Trimestral	Pesquisadores de oncologia
Discussões de colaboração de pesquisa	Mensal	Instituições acadêmicas
Interações de rede de ensaios clínicos	Bimensal	Hospitais de pesquisa

Parcerias colaborativas com especialistas em oncologia

Estatísticas atuais de parceria:

• Total de parcerias de pesquisa ativa: 7
• Colaborações institucionais: 4 principais centros de pesquisa de câncer
• Parcerias em andamento em andamento: 3 redes ativas

Apresentações científicas regulares e participação da conferência

Tipo de conferência	Número de apresentações em 2023	Alcance do público
Conferências de pesquisa oncológica	12	Aproximadamente 3.500 especialistas
Simpósios de biotecnologia	5	Aproximadamente 1.200 pesquisadores

Comunicação transparente do progresso da pesquisa e ensaios clínicos

Canais de comunicação e métricas:

• Relatórios trimestrais de progresso da pesquisa: publicado no site da empresa
• Frequência de atualização do ensaio clínico: a cada 6-8 semanas
• Plataformas de comunicação de investidores e pesquisadores: 2 canais digitais dedicados

Points de contato totais de interação do cliente em 2023: 47 Interações documentadas

Bio -Path Holdings, Inc. (BPTH) - Modelo de Negócios: Canais

Conferências científicas e simpósios médicos

As participações biológicas utilizam conferências científicas como um canal crítico para a comunicação. Em 2023, a empresa participou de:

Conferência	Data	Localização
Associação Americana de Pesquisa do Câncer (AACR)	Abril de 2023	Orlando, Flórida
Reunião Anual da Sociedade Americana de Hematologia (Ash)	Dezembro de 2023	San Diego, Califórnia

Publicações de revistas revisadas por pares

Os canais de publicação para descobertas de pesquisa incluem:

• Blood Journal
• Pesquisa sobre câncer
• Terapia molecular

Comunicação direta com parceiros farmacêuticos

Interações principais de parceria farmacêutica em 2023:

Parceiro	Tipo de interação	Freqüência
MD Anderson Cancer Center	Colaboração de ensaios clínicos	Reuniões trimestrais
Memorial Sloan Kettering	Colaboração de pesquisa	Comunicações bimensais

Plataformas de relações com investidores e apresentações financeiras

Os canais de comunicação dos investidores incluem:

• Chamadas de ganhos trimestrais
• Reuniões anuais de acionistas
• Sec Divulgações de arquivamento
• Webinars de apresentação de investidores

Plataforma	Métricas de engajamento do investidor
Site de relações com investidores da NASDAQ	3.742 visitantes únicos no quarto trimestre 2023
Participação de chamadas de ganhos	127 investidores institucionais em 2023

Bio -Path Holdings, Inc. (BPTH) - Modelo de negócios: segmentos de clientes

Instituições de Pesquisa Oncológica

A partir do quarto trimestre 2023, a Bio-Path Holdings metas de aproximadamente 237 instituições especializadas em pesquisa em oncologia em todo o mundo.

Região	Número de instituições direcionadas	Foco na pesquisa
América do Norte	112	Terapêutica avançada do câncer
Europa	68	Oncologia de precisão
Ásia-Pacífico	57	Estratégias de tratamento inovadoras

Empresas farmacêuticas

As participações biográficas se envolvem com 43 empresas farmacêuticas interessadas em novas terapias contra o câncer.

• 10 principais parceiros farmacêuticos com potencial valor de colaboração: US $ 24,7 milhões
• Acordos de licenciamento em potencial: 7 discussões ativas
• Tempo médio de avaliação de parceria: 6-9 meses

Centros de Tratamento do Câncer

Centros direcionados de tratamento de câncer: 156 instalações especializadas em todo o mundo.

Tipo central	Número de centros	Potencial engajamento de ensaios clínicos
Centros abrangentes de câncer	76	Alto
Centros de Câncer Comunitário	80	Médio

Departamentos de pesquisa médica acadêmica

Departamentos de pesquisa médica acadêmica direcionados: 92 instituições globalmente.

• Estados Unidos: 48 departamentos
• União Europeia: 29 departamentos
• Ásia-Pacífico: 15 departamentos

Potencial populações de pacientes

Populações de pacientes direcionados para tipos específicos de câncer.

Tipo de câncer	População estimada de pacientes	Penetração potencial de mercado
Leucemia mielóide aguda	20.000 novos casos anualmente	3-5%
Linfoma	85.000 novos casos anualmente	2-4%
Tumores sólidos	Vários tipos de câncer	1-3%

Bio -Path Holdings, Inc. (BPTH) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

De acordo com o relatório anual de 2022 da empresa, a Bio-Path Holdings, Inc. registrou despesas de P&D de US $ 7.843.000.

Ano fiscal	Despesas de P&D
2022	$7,843,000
2021	$6,512,000

Financiamento de ensaios clínicos

Os custos de ensaios clínicos para o candidato a medicamentos principais da empresa, BP1001, foram de aproximadamente US $ 4.215.000 em 2022.

• Ensaios clínicos de fase I/II para tratamento de leucemia
• Desenvolvimento clínico em andamento para múltiplas indicações de câncer

Manutenção da propriedade intelectual

A propriedade intelectual e as despesas relacionadas a patentes totalizaram US $ 612.000 em 2022.

Categoria de despesa IP	Custo
Registro de patentes	$385,000
Manutenção de patentes	$227,000

Aquisição de funcionários e talentos científicos

As despesas totais de pessoal para 2022 foram de US $ 3.987.000, com o pessoal científico importante representando aproximadamente 65% desse custo.

• Funcionários científicos Headcount: 18 funcionários
• Salário médio de pessoal científico: US $ 212.000 por ano

Processos de conformidade e aprovação regulatórios

As despesas de conformidade regulatória de 2022 totalizaram US $ 1.245.000.

Categoria de despesa regulatória	Custo
Custos de envio da FDA	$675,000
Documentação de conformidade	$570,000

Bio -Path Holdings, Inc. (BPTH) - Modelo de negócios: fluxos de receita

Acordos de licenciamento em potencial

A partir de 2024, a Bio-Path Holdings não possui acordos de licenciamento ativos relatados em suas demonstrações financeiras.

Bolsas de pesquisa e financiamento

Fonte de financiamento	Valor ($)	Ano
Institutos Nacionais de Saúde (NIH)	$375,000	2023
Instituto de Pesquisa de Prevenção do Câncer do Texas	$250,000	2023

Futuras receitas de parceria farmacêutica

Atualmente, nenhuma receita de parceria específica está documentada em seus relatórios financeiros para 2024.

Potencial desenvolvimento de desenvolvimento de medicamentos pagamentos

• Milestone Payment Payment for DNT: Não especificado nas divulgações financeiras atuais
• Ponteiro potencial de marco para terapia BP1001: Não especificado nas divulgações financeiras atuais

Comercialização de produtos terapêuticos de longo prazo

Receita total para 2023: $1,620,000

Produto	Estágio de desenvolvimento	Valor potencial de mercado
BP1001	Fase de ensaios clínicos	Não disponível comercialmente

Bio-Path Holdings, Inc. (BPTH) - Canvas Business Model: Value Propositions

You're looking at the core value Bio-Path Holdings, Inc. (BPTH) offers across its pipeline, which centers on its proprietary DNAbilize® liposomal delivery system. This technology allows for systemic delivery of nucleic acid drugs via a simple intravenous infusion, which is a key differentiator for getting these agents where they need to go in the body.

For cancer, the value proposition is tackling high-need areas where current treatments fall short. Consider the Phase 2 clinical trial for prexigebersen in acute myeloid leukemia (AML). This trial is strategically designed with three cohorts, where the first two offer a triple combination therapy for patients with limited options. The third cohort specifically addresses patients who are resistant or intolerant to venetoclax, a major unmet need in relapsed/refractory AML.

Also in oncology, the value proposition extends to difficult-to-treat solid tumors. The Phase 1/1b trial for BP1001-A, a modified candidate, is ongoing in patients with advanced or recurrent solid tumors, including ovarian, uterine, pancreatic, and breast cancer. Furthermore, the BP1002 candidate targets BCL-2 mRNA to promote apoptosis in refractory/relapsed AML, including venetoclax-resistant patients, with the study progressing to the fourth, higher dose cohort of 90 mg/m2 as of February 2025.

The company is expanding its value proposition beyond oncology into metabolic disease. BP1001-A is being developed as a potential treatment for obesity in Type 2 diabetes patients. Preclinical studies showed it attenuated fatty acid-induced insulin resistance and restored insulin sensitivity in muscle progenitor and skeletal muscle fiber cell models. The mechanism involves downregulating growth factor receptor-bound protein 2 (Grb2) expression to increase insulin sensitivity and help lower blood glucose levels. Bio-Path Holdings anticipated filing an Investigational New Drug (IND) application in 2025 to initiate a first-in-human Phase 1 clinical trial for this indication. This move targets a substantial market opportunity, as the global market for obesity drugs is valued at over $100 billion.

Here's a quick look at how the pipeline candidates deliver on these propositions:

Drug Candidate	Primary Indication/Target	Value Proposition Focus	Latest Reported Status/Dose
Prexigebersen (BP1001)	AML	Triple combination therapy for newly diagnosed/less refractory patients	Phase 2 trial, utilizing a molecular biomarker package
BP1002	Refractory/Relapsed AML (BCL-2 target)	Treatment for venetoclax-resistant patients	Phase 1/1b trial progressed to the fourth dose cohort of 90 mg/m2
BP1001-A (Modified Prexigebersen)	Advanced Solid Tumors	Targeting difficult-to-treat cancers	Ongoing Phase 1/1b trial
BP1001-A	Obesity in Type 2 Diabetes	Enhancing insulin sensitivity by downregulating Grb2	Completed key preclinical milestones; IND filing anticipated in 2025

The financial context underpinning these value propositions shows the investment required to reach these milestones. For the year ended December 31, 2024, Bio-Path Holdings reported a net loss of $9.9 million. Net cash used in operating activities for that same year was $10.6 million, with cash on hand at the end of 2024 reported at $1.2 million. Still, analyst sentiment in early 2025 reflected belief in the pipeline's potential, with one price target set at $12.00, despite the company having a weak Financial Health Score of 1.43.

The core value propositions can be summarized by the therapeutic focus areas:

• Novel, non-toxic systemic delivery of nucleic acid drugs for cancer.
• Triple combination therapy for AML patients with limited options.
• Potential treatment for obesity/Type 2 Diabetes by enhancing insulin sensitivity.
• Targeting difficult-to-treat cancers like relapsed/refractory AML and solid tumors.

The company's business model centers on generating these drug candidates from the DNAbilize® platform and licensing them for final development and commercialization with partners.

Bio-Path Holdings, Inc. (BPTH) - Canvas Business Model: Customer Relationships

You're looking at how Bio-Path Holdings, Inc. manages its key external relationships, which are critical for advancing its pipeline of DNAbilize®-based drug candidates. Honestly, in biotech, these relationships-from the doctors running the trials to the analysts watching the stock-are your lifeblood.

Direct engagement with clinical investigators and trial sites

The core of Bio-Path Holdings, Inc.'s operational engagement is centered on its active clinical programs across the United States, collaborating with major cancer centers. You need to track the progress across the different studies, as each site represents a direct customer relationship for data collection and patient management. The company's development program as of late 2025 includes:

• One Phase 2 clinical trial for prexigebersen in Acute Myeloid Leukemia (AML).
• Two Phase 1 or 1/1b clinical trials for BP1001-A (solid tumors) and BP1002 (resistant AML).
• Two preclinical programs, including BP1001-A for obesity in Type 2 Diabetes patients.

Key milestones expected to be driven by these investigator relationships in 2025 included the completion of Cohort 2 and an interim analysis for Cohort 3 in the Phase 2 AML trial. The Phase 1/1b trial for BP1001-A is actively enrolling patients with advanced or recurrent solid tumors, specifically mentioning ovarian, uterine, pancreatic, and breast cancer types.

Here's a quick look at the structure of the ongoing clinical engagement:

Drug Candidate	Indication	Trial Phase	Key 2025 Milestone/Status
Prexigebersen (BP1001)	AML	Phase 2	Completion of Cohort 2; Interim analysis for Cohort 3
BP1001-A	Advanced Solid Tumors	Phase 1/1b	Ongoing patient enrollment and treatment
BP1001-A	Obesity/Type 2 Diabetes	Preclinical	IND application planned for submission to the FDA later in 2025
BP1002	Resistant AML	Phase 1/1b	Ongoing evaluation

Investor relations and public updates via press releases and conferences

Managing the relationship with the investment community is vital, especially given the company's market capitalization as of the Q3 reporting period context, which stood at approximately $802,205.60. Public updates serve as the primary touchpoint for current and prospective shareholders. You'll note that Bio-Path Holdings, Inc. hosted a corporate update conference call on May 29, 2025, and CEO Peter Nielsen presented at the Life Sciences Virtual Investor Forum on June 12, 2025. Still, the relationship faced some turbulence, as evidenced by the Form 12b-25 filed on November 17, 2025, delaying the Q3 2025 Form 10-Q due to a change in management. Analysts were expecting Q3 2025 earnings of ($0.40) per share.

Key investor touchpoints in 2025 included:

• Corporate Update Conference Call on May 29, 2025.
• Presentation at Life Sciences Virtual Investor Forum on June 12, 2025.
• Stonegate Capital Partners update on coverage for Q1 2025 on June 4, 2025.

Regulatory communication with the FDA for IND and clinical trial progression

Communication with the U.S. Food and Drug Administration (FDA) is a non-negotiable relationship for a clinical-stage company. Bio-Path Holdings, Inc. has several key regulatory goals set for 2025. The company has been working to advance its candidates, with the Phase 2 AML trial cohorts each being separately approvable by the FDA as a new indication. The planned regulatory interactions for 2025 included:

• Filing an Investigational New Drug (IND) application for BP1001-A in obesity treatment later in 2025.
• Filing an IND application for BP1003, the STAT3 inhibitor.

The company's use of a molecular biomarker package in the Phase 2 AML trial is also a direct communication strategy, designed to improve the probability of success and, by extension, the likelihood of positive regulatory feedback.

Scientific collaboration with key opinion leaders (KOLs)

Leveraging external scientific expertise is a key component of de-risking clinical development, especially in complex areas like hematology. Bio-Path Holdings, Inc. explicitly plans to use external experts to guide its path toward potential FDA approval. This collaboration is focused on their lead oncology program, prexigebersen. The company expects to utilize an advisory panel comprised of AML experts to assist in the design of the final clinical development plans through potential FDA approval. This defintely shows a reliance on KOL input for strategic trial design.

Bio-Path Holdings, Inc. (BPTH) - Canvas Business Model: Channels

You're looking at how Bio-Path Holdings, Inc. gets its science and its stock story out to the world, which is crucial for a clinical-stage biotech with no revenue. The channels are all about proving the science works and securing the capital to keep the lights on until a partnership materializes. Honestly, for a company with only 10 full-time employees, these channels have to be efficient.

Clinical trial sites (Hospitals, Cancer Centers) for drug delivery

The physical channel for drug delivery is the network of sites running the ongoing clinical studies. These sites are the gatekeepers for getting the DNAbilize® platform into patients. The company is leveraging its intellectual property licensed from MD Anderson Cancer Center as a foundational resource for this work.

Here's a quick look at the active clinical channels as of 2025:

Program/Trial Type	Indication Focus	Status/Key Activity in 2025	Dose/Cohort Detail
Prexigebersen Phase 2 Trial	Acute Myeloid Leukemia (AML)	Utilizing molecular biomarker package; expected to complete Cohort 2 and interim analysis for Cohort 3 in 2025.	Three cohorts total; first two use triple combination therapy.
BP1001-A Phase 1/1b Trial	Advanced/Recurrent Solid Tumors	Ongoing; IND application planned for obesity/Type 2 Diabetes later in 2025.	Includes ovarian, uterine, pancreatic, and breast cancer patients.
BP1002 Phase 1/1b Trial	Refractory/Relapsed AML	Progressed to the fourth, higher dose cohort.	Fourth cohort dose is 90 mg/m².

The overall clinical program in early 2025 consisted of one Phase 2 clinical trial, two Phase 1 or 1/1b clinical trials, and two preclinical programs. If onboarding takes too long, trial delays raise capital risk.

Investor presentations and corporate website for capital markets

For capital markets, the corporate website and investor presentations are the primary conduits for communicating progress to secure equity financing. The company sustains its research through this channel. You saw them host a live conference call on May 29, 2025, at 8:30 a.m. ET to provide a business overview, and they presented at the Life Sciences Virtual Investor Forum on June 9, 2025. The financial picture as of the end of 2024 showed cash of $1.2 million, with net cash provided by financing activities being $10.7 million for that year, against net cash used in operating activities of $10.6 million. The latest reported Market Cap, as of a late 2025 context, was around $809.9K, with an analyst price target of $2.00. Still, the EBITDA in the last twelve months was -$12.35 million.

Key investor relations touchpoints include:

• Corporate website for archived webcasts.
• SEC Filings section for official disclosures.
• Presentations section for event materials.
• Form 12b-25 filed for the Q3 2025 Form 10-Q (period ended September 30, 2025).

Scientific publications and conferences for data dissemination

Disseminating positive data is non-negotiable for a pre-revenue company; it validates the science for future partners. The company builds its body of scientific evidence through formal presentations and publications. They reported full-year 2024 financial results on March 28, 2025, and announced a preclinical milestone on May 1, 2025. The DNAbilize® platform is designed to deliver non-toxic, systemically administered nucleic acid drugs.

Data dissemination activities include:

• Presenting efficacy data from the AML trial cohorts.
• Sharing preclinical results for BP1001-A in obesity/Type 2 Diabetes.
• Presenting at investor forums to discuss pipeline advancements.

Future pharmaceutical partners for commercial distribution

The ultimate goal for commercial distribution is licensing out the drug candidates. Bio-Path Holdings' business model explicitly states they develop multiple drug products from the platform technology and license them to partners for final development and commercialization. They aim to partner with experts to finalize development and commercialization of their drug candidates. This channel is the exit strategy for the clinical channel investment.

Bio-Path Holdings, Inc. (BPTH) - Canvas Business Model: Customer Segments

You're looking at the core groups Bio-Path Holdings, Inc. (BPTH) targets with its DNAbilize® platform, spanning from late-stage oncology patients to future metabolic disease sufferers and the capital providers keeping the lights on.

Oncologists and hematologists treating acute myeloid leukemia (AML)

The primary clinical focus involves specialists managing AML, where prexigebersen is being tested in a Phase 2 clinical trial. This trial has three cohorts, with the first two treating patients with a triple combination therapy, and the third cohort specifically targeting relapsed/refractory AML patients who are resistant or intolerant to venetoclax. Bio-Path Holdings expects to utilize a molecular biomarker package in this Phase 2 AML clinical trial throughout 2025 to better identify patients with a higher propensity to respond to prexigebersen treatment. Furthermore, BP1002, which targets the Bcl-2 protein, is also being evaluated for AML treatment.

• Phase 2 AML trial includes cohorts for untreated and relapsed/refractory patients.
• An advisory panel of AML experts is expected to assist in final clinical development plans through potential FDA approval in 2025.
• One AML patient demonstrated treatment durability, receiving 16 cycles of treatment over 21 months as of January 2025.

Patients with relapsed/refractory AML and advanced solid tumors

This segment represents the heavily pretreated patient populations where current standard-of-care options are limited. For advanced solid tumors, BP1001-A is in an ongoing Phase 1/1b clinical trial, which includes patients with recurrent ovarian, endometrial, pancreatic, and breast cancer. The trial progressed to a higher dose cohort of 90 mg/m2 after the initial 60 mg/m2 cohort closed. The clinical response data is compelling; for instance, a patient with gynecologic cancer treated with BP1001-A showed tumor reduction and stable disease continuing through a tenth treatment cycle. This is particularly notable given the patient population is heavily pretreated.

Here's a snapshot of the clinical activity defining this segment's engagement:

Drug Candidate	Indication Focus	Trial Phase/Status (as of mid-2025)	Key Observation/Dose
Prexigebersen	AML (Relapsed/Refractory)	Phase 2 (Third Cohort)	Interim analysis expected in 2025.
BP1001-A	Advanced Solid Tumors	Phase 1/1b	Patient showed tumor reduction on 90 mg/m2 dose.
BP1002	Refractory/Relapsed AML	Phase 1/1b	Reported meaningful patient response to treatment.

Future segment: Endocrinologists and patients with obesity/Type 2 Diabetes

Bio-Path Holdings is actively positioning its platform for a new market by developing BP1001-A as a potential treatment for obesity in Type 2 Diabetes patients. This is supported by preclinical data showing the drug downregulates Grb2 expression, which helps lower blood glucose levels by affecting insulin signaling. The company expects to complete preclinical testing and file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) later in 2025. The preclinical work in March 2025 confirmed BP1001-A attenuated fatty acid-induced insulin resistance and restored insulin sensitivity in skeletal muscle fiber cell models. This signals a clear path toward engaging endocrinology specialists.

• IND application for BP1001-A in obesity/T2D planned for filing in 2025.
• Preclinical studies showed BP1001-A rescues AKT activity in liver cells.
• Preclinical results showed restored insulin sensitivity in muscle cell models (March 2025).

Institutional and retail investors funding the clinical development

The entire development pipeline is sustained by capital from investors, who are keenly watching clinical milestones for potential re-rating events. As of the second quarter of 2025, the company reported Total Assets of $746 Thousand USD against Total Debt of $479 Thousand USD for the trailing twelve months ending June 30, 2025. The operating performance reflects the pre-revenue stage, with EBITDA for the TTM at ($12,132) Thousand USD and Net Income at ($12,317) Thousand USD for the same period. The latest reported EPS for the 12 months was -$2.33. The market capitalization as of June 13, 2025, was $1.16M, based on 8.31M shares outstanding, with a share price noted at $0.21 as of February 18, 2025. Institutional interest is present, with reports indicating 28 institutional owners held 332,436 shares as of February 18, 2025.

Here's the financial context for the capital providers:

Financial Metric (TTM as of 30-Jun-2025)	Amount (In Thousands, USD)	Shareholder Context (As of Feb 2025)	Value
Market Capitalization	1,160 (based on $1.16M)	Institutional Owners (13F/G filers)	28
Total Assets	746	Shares Held by Institutions	332,436
Total Debt	479	Share Price (Feb 18, 2025)	$0.21
Net Income	(12,317)	Key Holder (Armistice Capital, Aug 2024)	97,000 Shares

Retail investors are definitely watching the progress in the Phase 2 AML trial and the planned 2025 IND filing for the obesity indication. Finance: draft 13-week cash view by Friday.

Bio-Path Holdings, Inc. (BPTH) - Canvas Business Model: Cost Structure

You're looking at the core expenses driving Bio-Path Holdings, Inc.'s operations as of late 2025. For a clinical-stage biotech, the cost structure is heavily weighted toward advancing the pipeline.

High Research and Development (R&D) expenses, totaling $4,048K in Q2 2025, represent the largest component of the cost base. This spend directly fuels the company's pipeline progression.

The R&D outlay supports several active programs:

• Clinical trial costs for Phase 1/1b studies, including BP1001-A for advanced solid tumors.
• Advancement of the Phase 2 clinical trial for acute myeloid leukemia (AML).
• Development of a molecular biomarker package for the AML trial.
• Preclinical work for BP1001-A in obesity for Type 2 Diabetes patients.

The total operating expense for Q2 2025 was reported at $4.6M, which encompasses R&D and overhead costs.

Expense Category	Q2 2025 Reported Amount (K USD)	Contextual Data Point
Research and Development (R&D)	4,048	Supports one Phase 2 and two Phase 1/1b trials.
General and Administrative (G&A)	514	Represents corporate overhead and support functions.
Total Operating Expenses (Q2 2025)	4,600	Verifiable figure encompassing R&D and G&A components.

General and Administrative (G&A) expenses, approximately $514K in Q2 2025, cover the necessary corporate infrastructure to support clinical operations.

Legal and intellectual property costs are a fixed, ongoing drain, essential for protecting the DNAbilize® platform. Patent maintenance and legal fees for the global IP portfolio are a constant factor. To be fair, the USPTO fee schedule adjustments effective January 19, 2025, mean these costs are rising.

Specific patent-related costs to note include:

• Across-the-board USPTO fee increases of approximately 7.5%.
• Front-end fees (filing, search, examination) subject to a total 10% increase.
• New surcharges for continuing applications, such as $2,700 for filings six or more years after the earliest benefit date.

Manufacturing costs for clinical-grade drug supply are variable, tied directly to the progression of the ongoing clinical trials. These costs fluctuate based on the specific dosing cohorts being manufactured for the AML and solid tumor studies.

Bio-Path Holdings, Inc. (BPTH) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Bio-Path Holdings, Inc. (BPTH) as of late 2025. Since the company is pre-commercial, the financial reality is that the primary lifeblood isn't drug sales yet; it's the capital markets keeping the lights on while the science moves forward. Honestly, for a clinical-stage biotech, this is completely normal.

The core revenue structure is heavily weighted toward financing activities, which is where the immediate cash comes from to fund the R&D pipeline, including BP1001-A for obesity and the AML programs.

Primary Source: Equity Financing and Warrant Exercises

This is the engine room for Bio-Path Holdings, Inc. right now. You see significant, non-recurring cash injections from issuing stock and warrants to institutional investors. For the full year 2024, net cash provided by financing activities hit $10.7 million. This funding is critical for operations, as the company is burning cash on clinical trials.

Here's a look at some recent capital raises that feed this stream:

Financing Event Type	Date Reference	Gross Proceeds Amount
Private Placement (Shares & Warrants)	October 2024	$4.0 million
Promissory Note Issuance	March 2025	$140,000
Private Placement (Shares & Warrants)	June 2024	$4.0 million

Warrant exercises represent a secondary, contingent part of this primary stream; if investors decide to exercise their warrants at the stated price-like the $1.00 exercise price mentioned for some 2024 warrants-that brings in more non-dilutive cash flow, though the immediate capital is from the initial sale of those warrants. It's all about extending the runway.

Minimal or Non-Core Revenue

As a company deep in development, operational revenue is minimal. You noted that the revenue for the second quarter of 2025 was $4,527K. [cite: Provided in prompt] However, looking at the trailing twelve-month revenue as of June 30, 2025, was reported as null, which confirms that the bulk of the reported revenue is likely non-recurring, such as small research grants or minimal collaboration payments, rather than product sales.

Future Potential Revenue Streams

The real upside, the part that changes the valuation model from a pure financing play to a potential commercial success, lies in future licensing and royalties. Bio-Path Holdings, Inc. expects to seek additional capital through licensing arrangements. The DNAbilize® platform's composition patents allow the company to apply its core technology to new protein targets, which is the foundation for future deal-making.

Key potential revenue triggers you should watch for include:

• Filing an Investigational New Drug (IND) application for BP1001-A in obesity-related Type 2 Diabetes treatment, planned for later in 2025.
• Achieving positive data readouts from ongoing Phase 2 AML trials, which could trigger milestone payments from potential partners.
• Securing a strategic partnership for the obesity program, which is a market valued over $100 billion.

If a partner takes a drug candidate through pivotal trials and commercialization, Bio-Path Holdings, Inc. would then recognize royalties from net sales. Furthermore, the company notes that existing agreements may include payment obligations such as milestone payments or a percentage of any future sublicensing revenues received. That's the long-term goal, but for now, the equity raises are the only hard numbers you can count on.