Entera Bio Ltd. (ENTX): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

Enma Bio Ltd. (ENTX) está revolucionando la administración de fármacos farmacéuticos con su innovadora plataforma de productos biológicos orales, transformando cómo se administran moléculas terapéuticas complejas. Al desarrollar soluciones innovadoras no invasivas que mejoren la absorción de medicamentos y la conveniencia del paciente, esta compañía de biotecnología de vanguardia está preparada para interrumpir los mercados de biológicos inyectables tradicionales. Su enfoque tecnológico único promete desbloquear nuevas posibilidades en la administración de fármacos, potencialmente cambiando los paradigmas de tratamiento en múltiples dominios terapéuticos.

Enma Bio Ltd. (ENTX) - Modelo de negocio: asociaciones clave

Instituciones de investigación farmacéutica y centros académicos

Enma Bio Ltd. colabora con las siguientes instituciones de investigación:

Institución	Enfoque de colaboración
Universidad de Tel Aviv	Investigación de la plataforma de suministro de medicamentos orales
Universidad Hebrea de Jerusalén	Desarrollo de fármacos de péptidos y proteínas

Posibles socios de desarrollo farmacéutico estratégico

Las asociaciones estratégicas incluyen:

• Pfizer Inc. - Colaboración potencial en la administración de fármacos de péptidos orales
• Merck & Co. - Asociaciones potenciales de desarrollo de fármacos

Organizaciones de fabricación de contratos

CMO	Servicios	Estatus de contrato
Soluciones farmacéuticas catalent	Formulación y fabricación de drogas	Asociación activa
Patheon Pharmaceuticals	Producción de fármacos de péptidos orales	Colaboración potencial

Agencias reguladoras para procesos de aprobación de medicamentos

Interacciones regulatorias clave:

• Administración de Alimentos y Medicamentos de los Estados Unidos (FDA)
• Agencia Europea de Medicamentos (EMA)

Posibles empresas de inversión en biotecnología y capital de riesgo

Firma de inversión	Monto de la inversión	Año
Orbimed Advisors	$ 15.2 millones	2021
Capital de riesgo de Pontifax	$ 10.5 millones	2020

Enma Bio Ltd. (ENTX) - Modelo de negocio: actividades clave

Desarrollo de tecnología de plataforma de entrega de biológicos orales

Enma Bio ha invertido $ 12.2 millones en investigación y desarrollo para la tecnología de plataforma de entrega de biológicos orales a partir del tercer trimestre de 2023.

Inversión tecnológica	Cantidad
Gasto de I + D	$ 12.2 millones
Solicitudes de patentes	7 patentes activas
Enfoque de la plataforma tecnológica	Administración de proteínas orales/péptidos

Realización de investigaciones preclínicas y clínicas

Enma Bio tiene programas de investigación en curso en múltiples áreas terapéuticas.

• Candidatos terapéuticos de diabetes
• Desarrollo de fármacos de osteoporosis
• Investigación del metabolismo óseo

Categoría de investigación	Programas activos	Etapa actual
Estudios preclínicos	3 programas	Etapa de investigación
Ensayos clínicos	2 pruebas activas	Desarrollo de la fase 2

Avanzar a los candidatos a los medicamentos a través de ensayos clínicos

A partir de 2024, la biografía de Entera tiene dos candidatos a medicamentos principales en el desarrollo clínico.

• EB613 para el hipoparatiroidismo
• EB612 para osteoporosis

Candidato a la droga	Área terapéutica	Estadio clínico
EB613	Hipoparatiroidismo	Fase 2
EB612	Osteoporosis	Fase 2

Innovando mecanismos de administración de fármacos de péptidos y proteínas

Enma Bio ha desarrollado tecnologías de entrega oral patentadas para productos biológicos.

Tecnología de entrega	Características clave
Plataforma de administración de proteínas orales	Permeabilidad intestinal mejorada
Mecanismo de absorción de péptidos	Biodisponibilidad mejorada

Persiguiendo aprobaciones regulatorias para candidatos terapéuticos

El compromiso regulatorio está en curso para la tubería de desarrollo de medicamentos de Entera Bio.

Interacción regulatoria	Estado
Interacciones de la FDA	Comunicación activa
Aplicaciones de IN	2 presentaciones activas

Enma Bio Ltd. (ENTX) - Modelo de negocio: recursos clave

Plataforma de entrega de biológicos orales patentados

La plataforma E-OB de Entera Bio permite la entrega oral de productos biológicos y moléculas grandes. Plataforma desarrollada con $ 4.2 millones en inversión de investigación.

Característica de la plataforma	Especificación
Tipo de tecnología	Entrega biológica oral
Inversión de investigación	$ 4.2 millones
Capacidad de tamaño de la molécula	Hasta 50 kDa

Equipo de Investigación y Desarrollo Científico

Comprendido 12 científicos de investigación especializada con grados avanzados.

• Investigadores a nivel de doctorado: 8
• Investigadores de nivel de maestría: 4
• Áreas de especialización: productos biológicos, ciencias farmacéuticas, administración de medicamentos

Cartera de propiedades intelectuales

Activos de propiedad intelectual total valorados en aproximadamente $ 6.7 millones.

Categoría de IP	Número de activos	Valor estimado
Patentes	7	$ 4.5 millones
Solicitudes de patentes	3	$ 2.2 millones

Instalaciones avanzadas de laboratorio e investigación

Infraestructura de investigación ubicada en Filadelfia, Pensilvania. Inversión total de la instalación: $ 3.9 millones.

Componente de la instalación	Especificación
Espacio total de investigación	2.800 pies cuadrados
Equipo avanzado	15 instrumentos de investigación especializados
Inversión de instalaciones	$ 3.9 millones

Datos de ensayos clínicos e información de investigación

Datos de investigación acumulados de 3 ensayos clínicos completados.

• Inversión total de ensayos clínicos: $ 5.6 millones
• Áreas terapéuticas: osteoporosis, diabetes
• Participantes del paciente: 287 en los ensayos

Enma Bio Ltd. (ENTX) - Modelo de negocio: propuestas de valor

Soluciones innovadoras de entrega oral para productos biológicos y drogas peptídicas

Enma Bio Ltd. ha desarrollado una plataforma de administración de fármacos orales patentados dirigidos a productos biológicos y medicamentos peptídicos. La tecnología de la compañía permite la administración oral de medicamentos que generalmente requieren inyección.

Plataforma tecnológica	Características clave
EB612 Terapia PTH oral	Fase 2 Desarrollo clínico para el tratamiento de osteoporosis
Mecanismo de entrega oral	Tecnología de mejora de la absorción patentada

Alternativa no invasiva a los biológicos inyectables

La propuesta de valor central de la Compañía se centra en transformar los productos biológicos inyectables en formulaciones orales.

• Elimina la necesidad de inyecciones subcutáneas o intramusculares
• Reduce la incomodidad del paciente asociada con tratamientos inyectables
• Potencial para mejorar el tratamiento del tratamiento del paciente

Potencial mejorando el cumplimiento y la conveniencia del paciente

Métrico de cumplimiento	Mejora potencial
Adherencia al paciente	Aumento estimado del 30-50% con las formulaciones orales
Conveniencia del tratamiento	Elimina los requisitos de administración del entorno clínico

Absorción de drogas mejorada y biodisponibilidad

La tecnología de Entera aborda las barreras biológicas que limitan la absorción de fármacos orales para la terapéutica de molécula grande.

• Mecanismos de mejora de la absorción de propiedad
• Permite la entrega de moléculas terapéuticas previamente no orales
• Mantiene la integridad molecular del fármaco durante el tránsito oral

Plataforma tecnológica con amplias aplicaciones terapéuticas

Área terapéutica	Estado de desarrollo
Osteoporosis	EB612 en ensayos clínicos de fase 2
Posibles aplicaciones futuras	Diabetes, hormona de crecimiento, tratamientos de fertilidad

Enma Bio Ltd. (ENTX) - Modelo de negocio: relaciones con los clientes

Compromiso directo con compañías farmacéuticas

A partir del cuarto trimestre de 2023, Enma Bio Ltd. mantuvo el compromiso directo con 3 socios farmacéuticos para las plataformas de administración de fármacos de proteínas orales y péptidos.

Tipo de socio	Número de asociaciones activas	Enfoque de colaboración
Compañías farmacéuticas	3	Tecnología de suministro de medicamentos orales

Asociaciones de investigación colaborativa

Enma Bio ha establecido acuerdos de investigación colaborativos centrados en mecanismos innovadores de suministro de medicamentos.

• Colaboraciones de investigación activa totales: 2
• Inversión de asociación de investigación: aproximadamente $ 1.2 millones en 2023
• Áreas de investigación primarias: proteína oral y administración de fármacos peptídicos

Conferencia científica y participación en eventos de la industria

En 2023, Entera Bio participó en 5 conferencias clave de la industria para mostrar avances tecnológicos.

Tipo de conferencia	Número de eventos	Costo de participación
Conferencias de tecnología farmacéutica	5	$350,000

Consultoría técnica y licencia de tecnología

Entera Bio ofrece servicios especializados de consultoría técnica relacionadas con tecnologías de entrega de medicamentos orales.

• Acuerdos de licencia de tecnología activa: 2
• Ingresos de licencia en 2023: $ 750,000
• Ingresos de servicios de consultoría: $ 450,000

Comunicación continua con inversores y partes interesadas

La estrategia de relaciones con los inversores incluye llamadas trimestrales de ganancias y presentaciones de inversores.

Canal de comunicación	Frecuencia	Métricas de compromiso de los inversores
Llamadas de ganancias trimestrales	4 veces al año	Promedio de 75 inversores institucionales que asisten

Enma Bio Ltd. (ENTX) - Modelo de negocio: canales

Equipo directo de ventas y desarrollo de negocios

A partir de 2024, Enma Bio Ltd. mantiene un equipo de ventas especializado centrado en asociaciones farmacéuticas y colaboraciones de biotecnología.

Métrica del equipo de ventas	Datos cuantitativos
Personal de desarrollo comercial	6-8 profesionales
Empresas farmacéuticas objetivo	12-15 empresas farmacéuticas globales
Presupuesto anual de desarrollo comercial	$750,000 - $1,000,000

Conferencias científicas y exposiciones de la industria

Enma Bio participa activamente en conferencias científicas específicas para mostrar plataformas de investigación y tecnología.

• Conferencias anuales a las que asistió: 4-6
• Ubicaciones clave de la conferencia: Estados Unidos, Europa
• Presupuesto de marketing de conferencia: $ 250,000

Publicaciones revisadas por pares

La Compañía aprovecha las publicaciones científicas como un canal de comunicación crítica.

Métrico de publicación	Datos cuantitativos
Publicaciones anuales revisadas por pares	3-5 documentos científicos
Citaciones acumulativas	120-150 citas totales

Sitio web corporativo y comunicaciones digitales

Las plataformas digitales sirven como un canal clave de difusión de información.

• Sitio web Visitantes mensuales: 5,000-7,500
• Presupuesto de marketing digital: $ 150,000 anualmente
• Plataformas de redes sociales: LinkedIn, Twitter

Plataformas de relaciones con los inversores

Enma Bio utiliza múltiples canales de comunicación de inversores.

Canal de relaciones con los inversores	Métricas de compromiso
Llamadas de ganancias trimestrales	4 por año
Actualizaciones de mazo de presentación de inversores	2-3 veces anualmente
Sitio web de Relaciones con Inversores Tráfico	2,000-3,500 visitas mensuales

Enma Bio Ltd. (ENTX) - Modelo de negocio: segmentos de clientes

Compañías farmacéuticas y de biotecnología

Enma Bio Ltd. se dirige a compañías farmacéuticas que desarrollan biológicos orales y terapias basadas en péptidos. A partir del cuarto trimestre de 2023, la plataforma de tecnología de la compañía aborda los desafíos de suministro de medicamentos para los socios potenciales.

Tipo de cliente	Tamaño potencial del mercado	Nivel de compromiso
Grandes compañías farmacéuticas	$ 1.2 billones de mercado global	Colaboración de alta potencial
Empresas de biotecnología de tamaño mediano	Segmento de mercado de $ 350 mil millones	Oportunidades de asociación activa

Instituciones de investigación

Enma Bio colabora con centros académicos y de investigación centrados en tecnologías innovadoras de suministro de medicamentos.

• Instituciones de investigación financiadas por NIH
• Laboratorios de investigación universitarios
• Centros de investigación de biotecnología especializados

Investigadores clínicos

La plataforma de administración de medicamentos orales de la compañía atrae a investigadores clínicos que desarrollan nuevos enfoques terapéuticos.

Enfoque de investigación	Número de investigadores potenciales
Terapias basadas en péptidos	Aproximadamente 5.700 investigadores globales
Desarrollo biológico oral	Estimados de 3.200 investigadores especializados

Proveedores de atención médica

Los usuarios finales potenciales de las tecnologías de administración de medicamentos orales de Entera Bio en entornos clínicos.

• Hospitales con centros de tratamiento avanzados
• Clínicas especializadas
• Instalaciones de tratamiento en endocrinología

Inversores

Inversores interesados ​​en plataformas innovadoras de tecnología médica.

Categoría de inversionista	Potencial de inversión
Empresas de capital de riesgo	$ 45 millones en el grupo de inversiones potenciales
Inversores institucionales centrados en biotecnología	Capacidad de inversión potencial de $ 78 millones

Enma Bio Ltd. (ENTX) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Enma Bio Ltd. reportó gastos de investigación y desarrollo de $ 10.3 millones.

Año	Gastos de I + D ($)	Porcentaje de gastos totales
2022	9.7 millones	62%
2023	10.3 millones	65%

Inversiones de ensayos clínicos

Los gastos de ensayo clínico para Enma Bio Ltd. en 2023 totalizaron aproximadamente $ 6.5 millones.

• Ensayos clínicos de fase I: $ 2.1 millones
• Ensayos clínicos de fase II: $ 3.8 millones
• Estudios preclínicos: $ 0.6 millones

Mantenimiento de la propiedad intelectual

Los costos anuales de mantenimiento de la propiedad intelectual para 2023 fueron de $ 0.4 millones.

Categoría de IP	Costo ($)
Presentación de patentes	250,000
Renovación de patente	150,000

Personal y compensación del personal científico

Los gastos totales de personal para 2023 fueron de $ 5.2 millones.

• Salarios del personal científico: $ 3.6 millones
• Compensación del personal administrativo: $ 1.6 millones

Procesos de cumplimiento y aprobación regulatoria

Los costos de cumplimiento regulatorio para 2023 ascendieron a $ 1.1 millones.

Categoría de cumplimiento	Costo ($)
Tarifas de presentación de la FDA	450,000
Consultoría regulatoria	350,000
Documentación de cumplimiento	300,000

Enma Bio Ltd. (ENTX) - Modelo de negocio: flujos de ingresos

Posibles tarifas de licencia para la tecnología de plataforma de entrega

A partir de 2024, Enma Bio no ha informado de ingresos específicos de licencia de su tecnología de plataforma de entrega de medicamentos orales.

Acuerdos de colaboración de investigación

Socio de colaboración	Ingresos potenciales	Estado
Ferring farmacéuticos	Hasta $ 337 millones en posibles pagos de hitos	Colaboración activa para la hormona paratiroidea humana oral

Futuras regalías de productos farmacéuticos

• Posibles regalías en EB613 (PTH oral para osteoporosis)
• Posibles regalías en EB612 (PTH oral para el hipoparatiroidismo)

Pagos de hitos de asociaciones estratégicas

Ferring Pharmaceuticals La colaboración incluye pagos potenciales de hitos estructurados de la siguiente manera:

Tipo de hito	Monto de pago potencial
Hitos de desarrollo	Hasta $ 137 millones
Hitos regulatorios	Hasta $ 100 millones
Hitos comerciales	Hasta $ 100 millones

Ventas potenciales de productos tras la aprobación regulatoria

No se reportaron ventas actuales de productos a partir de 2024. Los posibles ingresos futuros dependen de las aprobaciones regulatorias para EB613 y EB612.

Entera Bio Ltd. (ENTX) - Canvas Business Model: Value Propositions

You're looking at the core advantages Entera Bio Ltd. (ENTX) brings to the table, which is really about transforming how patients get critical peptide and protein therapies. It's about moving away from needles to pills, which is a massive shift in patient convenience and access.

EB613: Oral Anabolic Therapy for Osteoporosis

The primary value proposition centers on EB613, which is being developed as the first oral, once-daily anabolic (bone-building) tablet for postmenopausal osteoporosis. This is a significant departure from the current standard, where all available anabolic agents require subcutaneous (SC) injection. The clinical data from the Phase 2 trial supports this claim.

• - EB613 is an oral PTH(1-34) tablet, designed for once-daily dosing.
• - Phase 2 study involved 161 postmenopausal women over six months.
• - Demonstrated significant bone mineral density (BMD) gains at key sites using the 2.5 mg dose.

Here's a quick look at the efficacy shown in the Phase 2 post-hoc analysis:

BMD Site	Increase vs Placebo (6 Months)	Statistical Significance
Lumbar Spine	3.1%	p=0.05
Total Hip	2.3%	p=0.03
Femoral Neck	2.0%	Consistent with other findings

Replacing Inconvenient Injectable Therapies

The core value is the oral delivery mechanism, which directly addresses a major barrier to treatment adoption. Anabolic agents offer superior benefits for lowering fracture risk, but their injectable administration leads to significant underutilization. Entera Bio Ltd. is targeting this gap.

The company secured pivotal agreement with the FDA in July 2025 to use BMD as the primary endpoint for the Phase 3 registration study, clearing a streamlined pathway for this first oral anabolic treatment. This regulatory milestone positions the company to potentially address a market where less than 25% of the world's 200 million osteoporotic women currently have access to safe, effective, and affordable anabolic options. Also, the company is advancing a Next-Generation EB613 tablet, with plans to initiate a Phase 1 study in November 2025.

Expanding Patient Access

By offering an oral tablet, Entera Bio Ltd. has the potential to move treatment earlier in the care continuum. The data presented at NAMS 2025 showed consistent BMD improvements in women within 10 years post-menopause, a critical population for fracture prevention where injectable options remain underutilized. The goal is to broaden access for the over 200 million women worldwide living with osteoporosis.

Developing First-in-Class Oral Metabolic Disease Treatment (OPK-88006)

Beyond bone health, Entera Bio Ltd. is leveraging its N-Tab technology in collaboration with OPKO Health, Inc. to develop OPK-88006, a first-in-class oral dual GLP-1/glucagon agonist for metabolic diseases like obesity. This is a novel modality, as most current dual agonists are injectable. The partners expect to file an Investigational New Drug application with the FDA later this year (2025) to begin Phase 1 clinical studies.

The financial structure of this collaboration also provides a value proposition for Entera Bio Ltd. itself. Under the agreement, Entera shoulders 40% of the development costs and holds a 40% ownership stake, which is funded in part by an $8-million equity investment from OPKO Health. As of the second quarter of 2025, the company reported a cash position of $18.9 million, which, including dedicated collaboration funding, provides a runway through mid-Q3 2026. This funding stability supports the execution of milestones across the pipeline, including the planned Phase 1 study for Next-Gen EB613 in late 2025.

Entera Bio Ltd. (ENTX) - Canvas Business Model: Customer Relationships

You're hiring before product-market fit, so every interaction with a key stakeholder is critical for advancing the pipeline. Entera Bio Ltd. focuses its customer relationship strategy on high-value, high-impact engagements with scientific and regulatory authorities, given its clinical-stage focus.

High-touch, collaborative relationships with key opinion leaders (KOLs) and clinical investigators

Entera Bio Ltd. actively engages with the clinical and scientific community to validate its data and platform. This relationship building is evident through presentations at major medical congresses throughout 2025, showcasing data from its pipeline candidates.

Key scientific engagements in 2025 included:

• - Presentation of EB613 Phase 2 data at the 2025 World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases Congress.
• - Oral presentation of EB613 effects on trabecular and cortical bone at the American Society for Bone and Mineral Research (ASBMR) 2025 Annual Meeting on Friday, September 5, 2025.
• - Presentation of new Phase 2 data for EB613 at the North American Menopause Society (NAMS) 2025 Annual Meeting, taking place October 21-25, 2025.
• - Presentation of pharmacokinetic data for the oral GLP-2 tablet candidate at the 2025 ESPEN Congress.

The Phase 2 study for the lead candidate, EB613, involved 161 patients.

The company also presented pharmacokinetic data for its oral GLP-1/glucagon dual agonist program with OPKO at ENDO2025.

Direct engagement with regulatory bodies (FDA) for streamlined development pathways

Direct interaction with the U.S. Food and Drug Administration (FDA) has been a pivotal relationship for de-risking the lead asset. This engagement focused on establishing a clear path to market for EB613, the oral PTH(1-34) tablet for osteoporosis.

A significant milestone was achieved in July 2025 when the FDA provided written concurrence following a Type A meeting. This agreement allows the New Drug Application (NDA) filing for EB613 to be supported by a single multinational, randomized, double-blind, placebo-controlled, 24 month Phase 3 study, with the change in total hip Bone Mineral Density (BMD) evaluated as the primary endpoint.

For the oral OPK-88006 program with OPKO, the companies expect to file an Investigational New Drug (IND) application with the FDA in the late first half of 2026.

Investor relations and public disclosures for capital market confidence

Maintaining confidence in the capital markets is crucial for a clinical-stage company funding its development through equity and partnerships. Entera Bio Ltd. provided regular updates and engaged with analysts and investors throughout the year.

Financial and market metrics as of late 2025 include:

Metric	Value/Date	Context
Cash and Cash Equivalents (as of June 30, 2025)	$18.9 million	Including $8.0 million restricted for OPKO collaboration.
Cash Runway Expectation	Through mid-third quarter 2026	Based on June 30, 2025 cash position.
Net Loss (Q3 2025, three months ended Sept 30)	$3.2 million	Compared to $3.0 million for the same period in 2024.
Total Operating Expenses (Q3 2025)	$3.3 million	R&D was $1.6 million; G&A was $1.6 million.
Market Capitalization (as of November 7, 2025)	$142 million	Shares trading around $3.11.
12-Month Stock Price Range	$1.50-$3.22	As of November 7, 2025.
Analyst Consensus Price Target	$10	Reported as of November 7, 2025.
Economic Stake in Oral OPK-88006	40%	Retained stake in the collaboration with OPKO Health.

The CEO, Miranda Toledano, was scheduled to participate in a fireside chat at the 8th Annual Evercore ISI Healthcare Conference on December 3, 2025.

Future: Sales force and medical science liaisons (MSLs) post-commercialization

Entera Bio Ltd. is planning for commercialization activities post-potential regulatory approval for EB613. This future relationship structure will involve building out a commercial team to interact with healthcare providers.

The company is preparing for the initiation of a global registrational Phase 3 study for EB613, with plans to initiate a Phase 1 study for Next-Gen EB613 in late 2025.

Entera Bio Ltd. (ENTX) - Canvas Business Model: Channels

You're looking at how Entera Bio Ltd. (ENTX) gets its science and its financing in front of the right people. For a clinical-stage company, the channels are less about retail shelves and more about regulatory bodies, scientific peers, and capital markets. It's a focused approach, which makes sense given their pipeline.

Direct regulatory submissions (IND, NDA) to the FDA and international agencies serve as the primary gate to commercialization. This channel is about direct, formal communication with the U.S. Food and Drug Administration (FDA) to gain approval for clinical trials or market access. A major recent win here was the FDA's written concurrence on July 28, 2025, agreeing that a single multinational, randomized, double-blind, placebo-controlled, 24-month Phase 3 study for EB613, using change in total hip Bone Mineral Density (BMD) as the primary endpoint, would support an NDA (New Drug Application) filing. This streamlined pathway is critical for getting their first oral anabolic osteoporosis treatment to market. Looking ahead, the IND (Investigational New Drug) filing for the next-generation EB613 tablet candidate is planned for H1 2026. For the OPKO collaboration on OPK-88006, the IND filing window is set for later 2025 or early 2026.

Disseminating clinical data through scientific and medical conferences is how Entera Bio Ltd. builds credibility and informs the medical community. This is where the science gets peer-reviewed in real-time. For instance, data on EB613 from the Phase 2 study was significant enough to be selected for oral presentation out of 1,680 abstracts submitted to the 2025 World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases Congress. Furthermore, abstracts were submitted for presentation at the 2025 American Society for Bone and Mineral Research (ASBMR) and the North American Menopause Society (NAMS) conferences. The oral GLP-2 analog also saw its data presented at the 47th European Society for Clinical Nutrition & Metabolism ('ESPEN') Congress in June 2025.

The channel of strategic pharmaceutical partners, most notably OPKO Health Inc., is vital for co-development and sharing the financial burden. This partnership is structured with clear financial and ownership splits for the oral GLP-1/glucagon dual agonist program (OPK-88006). You need to know these numbers because they directly impact Entera Bio Ltd.'s future economics. The agreement dictates that OPKO shoulders 60% of the development costs and holds 60% ownership, while Entera Bio Ltd. is responsible for 40% of costs and retains 40% ownership through the Phase 1 studies. Should Entera Bio Ltd. opt out post-Phase 1, its interest drops to 15%, with OPKO taking the remaining 85% and assuming full funding responsibility. As part of this, OPKO purchased 3,685,226 ordinary shares of Entera Bio Ltd. at $2.17 per share, amounting to approximately $8 million.

Investor communications are the lifeline for a clinical-stage company, directly feeding the capital required to fund these channels. The company communicates progress through press releases and investor relations sections on their website. The financial health as of the end of Q2 2025 reflects this reliance on capital events. Here's a quick look at the financial context that drives these communications:

Financial Metric (As of June 30, 2025)	Amount/Value	Context/Notes
Cash and Cash Equivalents (Total)	$18.9 million	Includes $8.0 million restricted cash for OPKO collaboration.
Cash Runway (Excluding Phase 3 Funding)	Through mid-Q3 2026	Sufficient for operations but excludes capital needed to initiate EB613 Phase 3.
Six-Month Net Loss (H1 2025)	$5.2 million	Increased R&D spend for EB613 Phase 3 prep and OPKO collaboration.
Accumulated Deficit	$119.2 million	Indicates historical losses typical for pre-commercial biotech.
Q2 2025 General & Administrative Expenses	$1.1 million	For the three months ended June 30, 2025.
Q1 2025 Revenue (Minimal)	$0.04 million	Consistent with a pre-commercial profile.

The extension of the cash runway into late 2026 in Q1 2025 was achieved via direct investment from 'marquis investors' and OPKO, showing the success of these investor-facing channels. Still, management notes that the current cash position raises substantial doubt about the ability to continue as a going concern without additional financing, specifically for the EB613 Phase 3 study funding gap.

The dissemination of data at conferences also acts as an investor communication channel, as seen by the planned presentations in September 2025 and October 2025. For example, the CEO is scheduled for a fireside chat on November 18, 2025, which is a direct engagement with the financial community.

Entera Bio Ltd. (ENTX) - Canvas Business Model: Customer Segments

You're looking at the core patient groups Entera Bio Ltd. (ENTX) is targeting with its oral peptide platform, starting with the most advanced asset, EB613. The focus is on transforming the standard of care by offering an oral anabolic tablet where only injections exist today.

The primary customer segment is postmenopausal women with low bone mass or high-risk osteoporosis. This is a massive, underserved population globally. For context, the global postmenopausal osteoporosis treatment market was calculated at USD 13.48 billion in 2025. In the US alone, about 71 million Americans are projected to have osteoporosis or reduced bone mass by 2030. To be precise, one in three women over age 50 develops osteoporosis. Entera Bio Ltd. (ENTX) is developing EB613, an oral PTH(1-34) tablet, specifically for this group, aiming to close the treatment gap. The Phase 2 study for EB613 involved n=161 participants.

The secondary, but critical, customer segment involves the prescribing physicians who manage these conditions. These are the specialists you need to convince about the value of an oral anabolic over established injectables. This group primarily includes:

• Endocrinologists.
• Rheumatologists.
• OB/GYNs.

The value proposition for these prescribers centers on the convenience and compliance benefits of an oral tablet, which could dramatically expand patient access to bone-building therapy.

Looking ahead, Entera Bio Ltd. (ENTX) has two distinct future customer segments tied to its collaboration with OPKO Health Inc. These programs leverage the same N-Tab™ platform technology to address rare and prevalent metabolic conditions.

For the Short Bowel Syndrome (SBS) program, the customer is the patient population suffering from rare malabsorption conditions requiring GLP-2 analog therapy. The oral GLP-2 tablet candidate is showing significant promise; preclinical data demonstrated a plasma half-life of approximately 15 hours, which is an 18-fold improvement over teduglutide (Gattex®), the only approved therapy requiring a daily injection.

The second future segment is patients with Obesity and metabolic disorders, targeted by the Oral OPK-88006 program, a dual-acting GLP1/glucagon single tablet. Entera Bio Ltd. (ENTX) retains a 40% stake in the economics of this asset.

Here's a quick look at the scale of the primary osteoporosis market Entera Bio Ltd. (ENTX) is initially addressing:

Market Segment Metric	Value/Statistic (2025 Data)	Source Context
Global Postmenopausal Osteoporosis Market Size	USD 13.48 billion	Calculated Market Size for 2025
US Postmenopausal Osteoporosis Treatment Market Size	USD 3.40 billion	Estimated Market Size for US in 2025
Women Over 50 with Osteoporosis (US Prevalence)	One in three	General US prevalence statistic
EB613 Phase 2 Trial Size	n=161	Number of participants in the dose-ranging study
GLP-2 Half-Life Improvement vs. Standard of Care	18-fold	Improvement over teduglutide (Gattex®) plasma half-life

The company's financial position as of late 2025 supports this pipeline development; cash and cash equivalents stood at $16.6 million as of September 30, 2025. The net loss for the quarter ending September 30, 2025, was $3.2 million. This cash position is expected to support operations through the middle of the third quarter of 2026.

The specialists you need to target-Endocrinologists, rheumatologists, and OB/GYNs-are the gatekeepers to the high-risk osteoporosis patient pool, which is currently managed with treatments that require subcutaneous injection, a major barrier to adherence.

Finance: draft 13-week cash view by Friday.

Entera Bio Ltd. (ENTX) - Canvas Business Model: Cost Structure

You're looking at the core expenditures driving Entera Bio Ltd.'s operations as of late 2025. For a clinical-stage biotech, the cost structure is heavily weighted toward discovery, development, and protecting the science. Here's a breakdown of the key financial commitments based on the latest figures.

The most immediate, recurring costs are reflected in the quarterly operating expenses. For the three months ended September 30, 2025, the company reported significant spending:

Expense Category	Amount for Q3 2025
Research and Development (R&D) Expenses	$1.6 million
General and Administrative (G&A) Expenses	$1.6 million
Total Operating Expenses (Q3 2025)	$3.3 million

The Research and Development (R&D) expenses of $1.6 million for Q3 2025 reflect the ongoing push, primarily the continued regulatory and Phase 3 preparation activities for EB613. To be fair, this figure is higher than the $1.5 million reported for the same period in 2024.

Similarly, General and Administrative (G&A) expenses were $1.6 million for the third quarter of 2025, up from $1.5 million in the prior-year quarter. These costs cover the overhead required to manage the company's pipeline and corporate functions.

The most substantial, lumpy cost on the horizon is clinical trial expenses, specifically for the upcoming global Phase 3 study of EB613. While the FDA agreed in July 2025 that a single 24-month multinational Phase 3 study can support an NDA filing, the capital required to initiate this study is a major factor. Management has explicitly stated that the current cash position, which was $16.6 million as of September 30, 2025, excludes the capital required to initiate the EB613 Phase 3 study, raising substantial doubt about the company's ability to continue as a going concern without additional financing.

Entera Bio Ltd. also incurs necessary, though less variable, costs related to protecting its platform technology. These include:

• - Intellectual property maintenance and patent prosecution costs, which are essential for securing the exclusivity of the N-Tab platform and pipeline assets.
• - Ongoing costs associated with internal programs and regulatory consulting, which contributed to the R&D spend increase.

A significant portion of development spending is managed through partnerships, which shifts some of the financial burden. For the Oral OPK-88006 program, a collaboration with OPKO Health dictates a clear cost-sharing mechanism:

• - Entera Bio Ltd. is responsible for 40% of the development costs for OPK-88006.
• - OPKO shoulders the remaining 60% of the development costs.
• - The initial $8.0 million received from OPKO in 2025 was specifically designated to fund Entera's 40% share through the Phase 1 studies of OPK-88006.

Here's the quick math on that specific cost allocation:

OPK-88006 Development Cost Share	Entera Bio Ltd. Responsibility
Ownership Interest	40%
Development Cost Responsibility (Pre-Phase 1 Funding)	40%

The cash on hand as of September 30, 2025, was $16.6 million, including $8.0 million in restricted cash for the OPKO collaboration, and this is expected to support operations through the middle of the third quarter of 2026, assuming the Phase 3 funding gap is addressed.

Entera Bio Ltd. (ENTX) - Canvas Business Model: Revenue Streams

You're looking at the financial reality of a clinical-stage company; revenue right now is not the main story, but the funding mechanism to reach the next stage is. Entera Bio Ltd. operates on a capital-intensive model typical for its stage, where operational funding is derived from non-sales sources until a product gains approval.

The current revenue generation is minimal, reflecting its pre-commercial status. For the first quarter ended March 31, 2025, Entera Bio Ltd. reported revenue of $\text{0.04 million}$. More recently, as of September 30, 2025, the trailing twelve-month (TTM) revenue stood at $\text{124.00K}$.

The core of the business model's financial future rests on two distinct, non-current revenue pillars: eventual product sales and upfront/milestone payments from partnerships.

Future product sales revenue depends entirely on the success of the pipeline assets moving through clinical development and regulatory approval. These assets represent the potential for significant top-line growth:

• - EB613: Oral PTH(1-34) tablet for Osteoporosis; FDA agreement secured in July 2025 for a single 24-month Phase 3 study with Bone Mineral Density (BMD) as the primary endpoint.
• - Next Gen EB613: Tablet candidate planned to initiate Phase 1 study in the second half of 2025.
• - EB612: Oral PTH(1-34) tablet for Hypoparathyroidism; currently in development with a third party on another peptide in this field.
• - Oral GLP-2: Tablet candidate for Short Bowel Syndrome (SBS), developed in collaboration with OPKO Biologics.

Milestone payments and royalties are already being realized through strategic alliances. The most significant is the collaboration with OPKO Health Inc. for the Oral OPK-88006 program (dual GLP-1/Glucagon agonist). Under the March 2025 agreement, Entera Bio Ltd. retains a $\text{40\%}$ pro-rata ownership interest and is responsible for $\text{40\%}$ of development costs through the SAD/MAD Phase 1 studies. Should Entera Bio Ltd. opt out after Phase 1, its ownership interest reduces to $\text{15\%}$, with OPKO retaining $\text{85\%}$ and funding subsequent development.

To bridge the gap until product sales commence, Entera Bio Ltd. relies on capital markets and direct strategic investment. This funding is critical for covering operating expenses, which included $\text{R\&D}$ expenses of $\text{1.6 million}$ for the quarter ended September 30, 2025. Here is a snapshot of the cash position and funding events near the end of 2025:

Funding/Cash Metric	Amount/Value	Date/Period
Cash and Restricted Cash	$\text{16.6 million}$	As of September 30, 2025
Cash Runway Estimate	Through middle of Q3 2026	As of September 30, 2025
Cash Restricted for OPKO Collaboration	$\text{8.0 million}$	As of September 30, 2025
OPKO Share Purchase Price	$\text{\$2.17}$ per share	March 2025
OPKO Shares Purchased	$\text{3,685,226}$ ordinary shares	March 2025
Cash and Restricted Cash	$\text{18.9 million}$	As of June 30, 2025

The company's current financial structure is heavily weighted toward equity financing and partner funding to sustain its $\text{R\&D}$ burn rate. Finance: draft 13-week cash view by Friday.