Bio-Path Holdings, Inc. (BPTH): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el mundo de vanguardia de la Terapéutica del Cáncer, Bio-Path Holdings, Inc. (BPTH) emerge como una compañía de biotecnología pionera que revoluciona las estrategias de tratamiento a través de su innovadora tecnología antisentido de drogas. Al dirigir el cáncer a nivel genético con una precisión sin precedentes, BPTH está listo para transformar cómo nos acercamos a las malignas desafiantes, ofreciendo esperanza a través de una investigación innovadora que podría ofrecer terapias más específicas y menos tóxicas para los pacientes que enfrentan desafíos oncológicos complejos.

Bio -Path Holdings, Inc. (BPTH) - Modelo de negocios: asociaciones clave

Asociaciones de investigación colaborativa con centros médicos académicos

A partir de 2024, Bio-Path Holdings mantiene asociaciones de investigación con los siguientes centros médicos académicos:

Institución	Enfoque de investigación	Estado de colaboración
Centro de cáncer de MD Anderson	Leucemia terapéutica	Colaboración activa
Centro Médico Southwestern de la Universidad de Texas	Terapéutica de ácido nucleico	Acuerdo de investigación en curso

Alianzas estratégicas con instituciones de investigación farmacéutica

Las asociaciones estratégicas de investigación farmacéutica incluyen:

• Instituto del Cáncer Dana-Farber
• Memorial Sloan Kettering Cancer Center
• Johns Hopkins Sidney Kimmel Centro integral de cáncer

Posibles acuerdos de licencia

Posibles acuerdos de licencia a partir de 2024:

Compañía	Candidato a la droga	Estado de licencia potencial
Terapéutica de precisión	Antisense Liposomal BP-100	Etapa de negociación

Organizaciones de investigación por contrato (CRO)

Asociaciones actuales de CRO para apoyo de ensayos clínicos:

• Ícono plc
• IQVIA Holdings Inc.
• Medpace Holdings

Presupuesto total de apoyo de ensayos clínicos para 2024: $ 3.2 millones

Bio -Path Holdings, Inc. (BPTH) - Modelo de negocio: actividades clave

Desarrollo de la terapéutica contra el cáncer antisentido

Bio-Path Holdings se centra en desarrollar Terapéutica contra el cáncer antisentido dirigido a vías moleculares específicas. A partir de 2024, la compañía tiene:

Plataforma terapéutica	Estado de desarrollo	Indicación objetivo
Prexigebersen (BP1001)	Estadio clínico	Leucemia mieloide aguda
BP1002	Investigación preclínica	Tumores sólidos

Realización de investigaciones preclínicas y clínicas

Las actividades de investigación incluyen:

• Estrategias de orientación molecular
• Diseño de oligonucleótidos antisentido
• Evaluación farmacológica

Gestión de la tubería de descubrimiento y desarrollo de drogas

Etapa de investigación	Número de programas	Inversión (2024)
Preclínico	2	$ 3.2 millones
Ensayos clínicos	1	$ 5.7 millones

Persiguiendo aprobaciones regulatorias

Actividades de presentación regulatoria para 2024:

• Preparación de la aplicación de la FDA Investigational New Drug (IND)
• Desarrollo del protocolo del ensayo clínico
• Documentación de cumplimiento regulatorio

Bio -Path Holdings, Inc. (BPTH) - Modelo de negocio: recursos clave

Plataforma de desarrollo de fármacos antisentido

Bio-Path Holdings utiliza un Plataforma de tecnología antisentido DNabilily® para desarrollar tratamientos contra el cáncer.

Característica de la plataforma	Detalles específicos
Tipo de tecnología	Tecnología de antisentido de nanopartículas de lipídicas neutrales
Estado de patente	Tecnología de plataforma de protección de patentes múltiples emitidas
Etapa de desarrollo	Tubería preclínica y clínica avanzada

Cartera de propiedades intelectuales

Bio-Path Holdings mantiene una sólida cartera de propiedad intelectual de tecnología de tratamiento del cáncer.

• Número total de patentes emitidas: 15
• Protección de patentes que cubre múltiples enfoques terapéuticos del cáncer
• Acuerdos de licencia exclusivos para innovaciones tecnológicas clave

Equipo de investigación científica

Composición del equipo de investigación	Número
Personal de investigación total	12 investigadores de oncología especializada
Investigadores a nivel de doctorado	8 miembros del personal científico
Experiencia de investigación combinada	Más de 120 años en investigación oncológica

Instalaciones avanzadas de laboratorio e investigación

Bio-Path Holdings opera infraestructura de investigación especializada.

• Espacio total de la instalación de investigación: 5,000 pies cuadrados
• Laboratorios avanzados de cultivo celular
• Equipo de investigación de biología molecular
• Capacidades de investigación de BioseFety Nivel 2

Capital financiero

Métrica financiera	Valor 2023
Gastos totales de investigación y desarrollo	$ 6.2 millones
Equivalentes de efectivo y efectivo	$ 3.8 millones
Presupuesto de investigación anual	$ 5.5 millones

Bio -Path Holdings, Inc. (BPTH) - Modelo de negocio: propuestas de valor

Tecnología de medicamentos antisentido innovador dirigido al tratamiento del cáncer

La propuesta de valor clave de Bio-Path Holdings se centra en Tecnología antisentido liposomal (LBPD) para el tratamiento del cáncer. A partir de 2024, la compañía ha desarrollado:

• BP-1001: Dirigir el gen BCL-2 en múltiples tipos de cáncer
• BP-1002: apuntar a mutaciones de oncogene Ras

Candidato a la droga	Tipo de cáncer objetivo	Estadio clínico
BP-1001	Leucemia mieloide aguda	Ensayo clínico de fase 1/2
BP-1002	Tumores sólidos	Desarrollo preclínico

Potencial para terapias de cáncer más precisas y menos tóxicas

La tecnología de la compañía demuestra:

• Reducción de la toxicidad sistémica en comparación con la quimioterapia tradicional
• Mecanismo mejorado de administración de medicamentos
• Potencial para atacar mutaciones genéticas específicas

Característica de terapia	Quimioterapia tradicional	Tecnología LBPD biológica
Toxicidad sistémica	Alto	Reducido
Orientación de precisión	Limitado	Mejorado

Enfoque único para el silenciamiento génico en las células cancerosas

Propietario de Bio-Path Tecnología antisentido liposomal habilita:

• Supresión de genes celulares directos
• Efectos minimizados fuera del objetivo
• Potencial para estrategias de tratamiento personalizadas

Estrategias de tratamiento personalizadas para tipos de cáncer desafiantes

La investigación de la compañía se centra en:

• Leucemia mieloide aguda (AML)
• Cáncer de pulmón
• Cáncer de páncreas
• Tumores sólidos metastásicos

Tipo de cáncer	Necesidad médica insatisfecha	Enfoque biológico
Leucemia mieloide aguda	Opciones de tratamiento limitadas	Orientación del gen BP-1001
Tumores sólidos metastásicos	Altas tasas de mortalidad	Silenciamiento de genes de precisión

Bio -Path Holdings, Inc. (BPTH) - Modelo de negocios: relaciones con los clientes

Compromiso directo con la comunidad de investigación médica

A partir del cuarto trimestre de 2023, Bio-Path Holdings mantiene el compromiso directo a través de:

Método de compromiso	Frecuencia	Público objetivo
Reuniones de la junta asesora científica	Trimestral	Investigadores de oncología
Discusiones de colaboración de investigación	Mensual	Instituciones académicas
Interacciones de red de ensayos clínicos	Bimensual	Investigar hospitales

Asociaciones colaborativas con especialistas en oncología

Estadísticas de asociación actuales:

• Asociaciones de investigación activa totales: 7
• Colaboraciones institucionales: 4 principales centros de investigación del cáncer
• Asociaciones de ensayos clínicos en curso: 3 redes activas

Presentaciones científicas regulares y participación de la conferencia

Tipo de conferencia	Número de presentaciones en 2023	Alcance de la audiencia
Conferencias de investigación oncológica	12	Aproximadamente 3.500 especialistas
Simposios de biotecnología	5	Aproximadamente 1.200 investigadores

Comunicación transparente del progreso de la investigación y ensayos clínicos

Canales de comunicación y métricas:

• Informes de progreso de investigación trimestral: publicado en el sitio web de la compañía
• Frecuencia de actualización del ensayo clínico: cada 6-8 semanas
• Plataformas de comunicación de inversores e investigadores: 2 canales digitales dedicados

Puntos de contacto de interacción total del cliente en 2023: 47 interacciones documentadas

Bio -Path Holdings, Inc. (BPTH) - Modelo de negocio: canales

Conferencias científicas y simposios médicos

Bio-Path Holdings utiliza conferencias científicas como un canal crítico para la comunicación. En 2023, la compañía participó en:

Conferencia	Fecha	Ubicación
Asociación Americana para la Investigación del Cáncer (AACR)	Abril de 2023	Orlando, Florida
Reunión anual de la Sociedad Americana de Hematología (Ash)	Diciembre de 2023	San Diego, California

Publicaciones de revistas revisadas por pares

Los canales de publicación para los resultados de la investigación incluyen:

• Diario de sangre
• Investigación del cáncer
• Terapia molecular

Comunicación directa con socios farmacéuticos

Interacciones clave de asociación farmacéutica en 2023:

Pareja	Tipo de interacción	Frecuencia
Centro de cáncer de MD Anderson	Colaboración de ensayos clínicos	Reuniones trimestrales
Memorial Sloan Kettering	Colaboración de investigación	Comunicaciones bimensuales

Plataformas de relaciones con inversores y presentaciones financieras

Los canales de comunicación de los inversores incluyen:

• Llamadas de ganancias trimestrales
• Reuniones anuales de accionistas
• SEC que presenta divulgaciones
• Sebinarios web de presentación de inversores

Plataforma	Métricas de compromiso de los inversores
Sitio web de Nasdaq Investor Relations	3.742 visitantes únicos en el cuarto trimestre de 2023
Participación de llamadas de ganancias	127 inversores institucionales en 2023

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

Instituciones de investigación de oncología

A partir del cuarto trimestre de 2023, Bio-Path Holdings se dirige a aproximadamente 237 instituciones de investigación de oncología especializada a nivel mundial.

Región	Número de instituciones específicas	Enfoque de investigación
América del norte	112	Terapéutica avanzada del cáncer
Europa	68	Oncología de precisión
Asia-Pacífico	57	Estrategias de tratamiento innovadoras

Compañías farmacéuticas

Bio-Path Holdings se involucra con 43 compañías farmacéuticas interesadas en nuevas terapias contra el cáncer.

• Los 10 principales socios farmacéuticos con valor de colaboración potencial: $ 24.7 millones
• Posibles acuerdos de licencia: 7 discusiones activas
• Tiempo de evaluación promedio de la asociación: 6-9 meses

Centros de tratamiento del cáncer

Centros de tratamiento de cáncer dirigidos: 156 instalaciones especializadas en todo el mundo.

Tipo central	Número de centros	Compromiso potencial del ensayo clínico
Centros de cáncer integrales	76	Alto
Centros de cáncer comunitario	80	Medio

Departamentos de investigación médica académica

Departamentos de investigación médica académica específicas: 92 instituciones a nivel mundial.

• Estados Unidos: 48 departamentos
• Unión Europea: 29 departamentos
• Asia-Pacífico: 15 departamentos

Populaciones de pacientes potenciales

Poblaciones de pacientes dirigidas para tipos de cáncer específicos.

Tipo de cáncer	Población de pacientes estimada	Penetración potencial del mercado
Leucemia mieloide aguda	20,000 casos nuevos anualmente	3-5%
Linfoma	85,000 casos nuevos anualmente	2-4%
Tumores sólidos	Múltiples tipos de cáncer	1-3%

Bio -Path Holdings, Inc. (BPTH) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Según el informe anual de 2022 de la compañía, Bio-Path Holdings, Inc. reportó gastos de I + D de $ 7,843,000.

Año fiscal	Gastos de I + D
2022	$7,843,000
2021	$6,512,000

Financiación del ensayo clínico

Los costos de ensayos clínicos para el candidato principal de drogas de la compañía, BP1001, fueron de aproximadamente $ 4,215,000 en 2022.

• Ensayos clínicos de fase I/II para el tratamiento de la leucemia
• Desarrollo clínico en curso para múltiples indicaciones de cáncer

Mantenimiento de la propiedad intelectual

La propiedad intelectual y los gastos relacionados con la patente totalizaron $ 612,000 en 2022.

Categoría de gastos de IP	Costo
Presentación de patentes	$385,000
Mantenimiento de patentes	$227,000

Adquisición de personal y talento científico

Los gastos totales de personal para 2022 fueron de $ 3,987,000, con personal científico clave que representa aproximadamente el 65% de este costo.

• Personal de personal científico: 18 empleados
• Salario promedio de personal científico: $ 212,000 por año

Procesos de cumplimiento y aprobación regulatoria

Los gastos de cumplimiento regulatorio para 2022 ascendieron a $ 1,245,000.

Categoría de gastos regulatorios	Costo
Costos de envío de la FDA	$675,000
Documentación de cumplimiento	$570,000

Bio -Path Holdings, Inc. (BPTH) - Modelo de negocios: flujos de ingresos

Posibles acuerdos de licencia

A partir de 2024, Bio-Path Holdings no tiene acuerdos de licencia activos reportados en sus estados financieros.

Subvenciones de investigación y financiación

Fuente de financiación	Monto ($)	Año
Institutos Nacionales de Salud (NIH)	$375,000	2023
Instituto de Investigación de Prevención del Cáncer de Texas	$250,000	2023

Ingresos futuros de asociación farmacéutica

No se documentan actualmente los ingresos de asociación específicos en sus informes financieros para 2024.

Pagos potenciales de desarrollo de fármacos

• Pago de hito potencial para la plataforma DNT: no se especifica en las divulgaciones financieras actuales
• Pago de hito potencial para la terapia BP1001: no se especifica en las divulgaciones financieras actuales

Comercialización de productos terapéuticos a largo plazo

Ingresos totales para 2023: $1,620,000

Producto	Etapa de desarrollo	Valor de mercado potencial
BP1001	Fase de ensayo clínico	No comercialmente disponible

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.