Entera Bio Ltd. (ENTX): Modelo de Negócios Canvas [Jan-2025 Atualizado]

A Entera Bio Ltd. (ENTX) está revolucionando a entrega de medicamentos farmacêuticos com sua inovadora plataforma de biológicos orais, transformando como as moléculas terapêuticas complexas são administradas. Ao desenvolver soluções inovadoras não invasivas que melhoram a absorção de medicamentos e a conveniência do paciente, esta empresa de biotecnologia de ponta está pronta para interromper os mercados tradicionais de biológicos injetáveis. Sua abordagem tecnológica única promete desbloquear novas possibilidades na administração de medicamentos, potencialmente mudando os paradigmas de tratamento em vários domínios terapêuticos.

Entera Bio Ltd. (ENTX) - Modelo de negócios: Parcerias -chave

Instituições de pesquisa farmacêutica e centros acadêmicos

A Entera Bio Ltd. colabora com as seguintes instituições de pesquisa:

Instituição	Foco de colaboração
Universidade de Tel Aviv	Pesquisa de plataforma de entrega de medicamentos oral
Universidade Hebraica de Jerusalém	Desenvolvimento de medicamentos para peptídeo e proteína

Potenciais parceiros de desenvolvimento farmacêutico estratégico

Parcerias estratégicas incluem:

• Pfizer Inc. - Colaboração potencial na administração de medicamentos peptídicos oral
• Merck & Co. - Possíveis parcerias de desenvolvimento de medicamentos

Organizações de fabricação contratadas

CMO	Serviços	Status do contrato
Soluções farmacêuticas catalentas	Formulação e fabricação de drogas	Parceria ativa
Pathon Pharmaceuticals	Produção de medicamentos peptídicos oral	Colaboração potencial

Agências regulatórias para processos de aprovação de medicamentos

Principais interações regulatórias:

• Administração de Alimentos e Medicamentos dos EUA (FDA)
• Agência Europeia de Medicamentos (EMA)

Empresas potenciais de investimento em biotecnologia e capital de risco

Empresa de investimentos	Valor do investimento	Ano
Consultores orbimed	US $ 15,2 milhões	2021
Capital de risco Pontifax	US $ 10,5 milhões	2020

Entera Bio Ltd. (ENTX) - Modelo de negócios: Atividades -chave

Desenvolvendo tecnologia de plataforma de entrega de biológicos orais

A Entera Bio investiu US $ 12,2 milhões em pesquisa e desenvolvimento para a tecnologia da plataforma de entrega de biológicos orais a partir do terceiro trimestre de 2023.

Investimento em tecnologia	Quantia
Despesas de P&D	US $ 12,2 milhões
Aplicações de patentes	7 patentes ativas
Foco da plataforma de tecnologia	Entrega de proteína/peptídeo oral

Condução de pesquisa pré -clínica e clínica

A Entera Bio possui programas de pesquisa em andamento em várias áreas terapêuticas.

• Candidatos terapêuticos para diabetes
• Osteoporose Desenvolvimento de medicamentos
• Pesquisa de metabolismo ósseo

Categoria de pesquisa	Programas ativos	Estágio atual
Estudos pré -clínicos	3 programas	Estágio de investigação
Ensaios clínicos	2 ensaios ativos	Desenvolvimento da Fase 2

Avançar candidatos a drogas através de ensaios clínicos

A partir de 2024, Entera Bio possui dois candidatos a medicamentos primários no desenvolvimento clínico.

• EB613 para hipoparatireoidismo
• EB612 para osteoporose

Candidato a drogas	Área terapêutica	Estágio clínico
EB613	Hipoparatireoidismo	Fase 2
EB612	Osteoporose	Fase 2

Mecanismos de entrega de medicamentos para peptídeos e proteínas inovadores

A Entera Bio desenvolveu tecnologias proprietárias de entrega oral para biológicos.

Tecnologia de entrega	Principais recursos
Plataforma de entrega de proteínas oral	Permeabilidade intestinal aprimorada
Mecanismo de absorção de peptídeos	Biodisponibilidade aprimorada

Buscando aprovações regulatórias para candidatos terapêuticos

O envolvimento regulatório está em andamento para o pipeline de desenvolvimento de medicamentos da Entera Bio.

Interação regulatória	Status
Interações FDA	Comunicação ativa
Aplicações IND	2 envios ativos

Entera Bio Ltd. (ENTX) - Modelo de negócios: Recursos -chave

Plataforma de entrega de biológicos orais proprietários

A plataforma E-OB da Entera Bio permite a entrega oral de biológicos e moléculas grandes. Plataforma desenvolvida com US $ 4,2 milhões em investimento em pesquisa.

Característica da plataforma	Especificação
Tipo de tecnologia	Entrega de biológicos orais
Investimento em pesquisa	US $ 4,2 milhões
Capacidade de tamanho de molécula	Até 50 kDa

Equipe de Pesquisa e Desenvolvimento Científica

Compreende 12 cientistas de pesquisa especializados com graus avançados.

• Pesquisadores no nível de doutorado: 8
• Pesquisadores em nível de mestrado: 4
• Áreas de especialização: biológicos, ciências farmacêuticas, administração de medicamentos

Portfólio de propriedade intelectual

Ativos de propriedade intelectual total avaliados em Aproximadamente US $ 6,7 milhões.

Categoria IP	Número de ativos	Valor estimado
Patentes	7	US $ 4,5 milhões
Aplicações de patentes	3	US $ 2,2 milhões

Instalações avançadas de laboratório e pesquisa

Infraestrutura de pesquisa localizada em Filadélfia, Pensilvânia. Investimento total da instalação: US $ 3,9 milhões.

Componente da instalação	Especificação
Espaço total de pesquisa	2.800 pés quadrados
Equipamento avançado	15 instrumentos de pesquisa especializados
Investimento da instalação	US $ 3,9 milhões

Dados de ensaios clínicos e insights de pesquisa

Dados de pesquisa acumulados de 3 ensaios clínicos concluídos.

• Investimento total do ensaio clínico: US $ 5,6 milhões
• Áreas terapêuticas: osteoporose, diabetes
• Participantes do paciente: 287 entre os ensaios

Entera Bio Ltd. (ENTX) - Modelo de Negócios: Proposições de Valor

Soluções inovadoras de entrega oral para medicamentos biológicos e peptídicos

A Entera Bio Ltd. desenvolveu uma plataforma proprietária de administração oral de medicamentos direcionada a medicamentos biológicos e peptídicos. A tecnologia da empresa permite a administração oral de medicamentos que normalmente exigem injeção.

Plataforma de tecnologia	Principais características
Terapia com PTH oral EB612	Desenvolvimento clínico de fase 2 para tratamento de osteoporose
Mecanismo de entrega oral	Tecnologia de aprimoramento de absorção proprietária

Alternativa não invasiva aos biológicos injetáveis

A proposta de valor principal da empresa se concentra na transformação de biológicos injetáveis ​​em formulações orais.

• Elimina a necessidade de injeções subcutâneas ou intramusculares
• Reduz o desconforto do paciente associado a tratamentos injetáveis
• Potencial para melhorar a adesão ao tratamento do paciente

Potencial melhor conformidade do paciente e conveniência

Métrica de conformidade	Melhoria potencial
Adesão ao paciente	Aumento estimado de 30 a 50% com formulações orais
Conveniência do tratamento	Elimina os requisitos de administração de configurações clínicas

Absorção e biodisponibilidade aprimoradas de drogas

A tecnologia de Entera aborda as barreiras biológicas que limitam a absorção de drogas orais para terapêuticas de grandes moléculas.

• Mecanismos de aprimoramento de absorção proprietários
• Permite a entrega de moléculas terapêuticas anteriormente não-orais
• Mantém a integridade molecular de medicamentos durante o trânsito oral

Plataforma tecnológica com amplas aplicações terapêuticas

Área terapêutica	Status de desenvolvimento
Osteoporose	EB612 em ensaios clínicos da Fase 2
Possíveis aplicações futuras	Diabetes, hormônio do crescimento, tratamentos de fertilidade

Entera Bio Ltd. (ENTX) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com empresas farmacêuticas

A partir do quarto trimestre 2023, a Entera Bio Ltd. manteve o envolvimento direto com 3 parceiros farmacêuticos para plataformas de entrega de proteínas e peptídeos de proteínas orais.

Tipo de parceiro	Número de parcerias ativas	Foco de colaboração
Empresas farmacêuticas	3	Tecnologia de entrega de medicamentos oral

Parcerias de pesquisa colaborativa

A Entera Bio estabeleceu acordos de pesquisa colaborativa com foco em mecanismos inovadores de administração de medicamentos.

• Total de colaborações de pesquisa ativa: 2
• Investimento em parceria de pesquisa: aproximadamente US $ 1,2 milhão em 2023
• Áreas de pesquisa primária: proteína oral e entrega de medicamentos peptídicos

Conferência Científica e Participação de Eventos da Indústria

Em 2023, Entera Bio participou de 5 principais conferências do setor para mostrar avanços tecnológicos.

Tipo de conferência	Número de eventos	Custo de participação
Conferências de tecnologia farmacêutica	5	$350,000

Consultoria técnica e licenciamento de tecnologia

A Entera Bio oferece serviços especializados de consultoria técnica relacionados às tecnologias de administração de medicamentos orais.

• Acordos de licenciamento de tecnologia ativa: 2
• Receita de licenciamento em 2023: $ 750.000
• Receita de serviços de consultoria: US $ 450.000

Comunicação em andamento com investidores e partes interessadas

A estratégia de relações com investidores inclui chamadas de ganhos trimestrais e apresentações de investidores.

Canal de comunicação	Freqüência	Métricas de engajamento do investidor
Chamadas de ganhos trimestrais	4 vezes por ano	Média 75 investidores institucionais presentes

Entera Bio Ltd. (ENTX) - Modelo de Negócios: Canais

Equipe direta de vendas e desenvolvimento de negócios

A partir de 2024, a Entera Bio Ltd. mantém uma equipe de vendas especializada focada em parcerias farmacêuticas e colaborações de biotecnologia.

Métrica da equipe de vendas	Dados quantitativos
Equipe de desenvolvimento de negócios	6-8 profissionais
Companhias farmacêuticas -alvo	12-15 empresas farmacêuticas globais
Orçamento anual de desenvolvimento de negócios	$750,000 - $1,000,000

Conferências científicas e exposições da indústria

A Entera Bio participa ativamente de conferências científicas direcionadas para mostrar plataformas de pesquisa e tecnologia.

• Conferências anuais participaram: 4-6
• Locais principais da conferência: Estados Unidos, Europa
• Orçamento de marketing da conferência: US $ 250.000

Publicações revisadas por pares

A empresa utiliza publicações científicas como um canal de comunicação crítico.

Métrica de publicação	Dados quantitativos
Publicações anuais revisadas por pares	3-5 artigos científicos
Citações cumulativas	120-150 Citações totais

Site corporativo e comunicações digitais

As plataformas digitais servem como um canal de disseminação de informações importantes.

• Website Visitantes mensais: 5.000-7.500
• Orçamento de marketing digital: US $ 150.000 anualmente
• Plataformas de mídia social: LinkedIn, Twitter

Plataformas de relações com investidores

A Entera Bio utiliza vários canais de comunicação de investidores.

Canal de relações com investidores	Métricas de engajamento
Chamadas de ganhos trimestrais	4 por ano
Atualizações de deck de apresentação do investidor	2-3 vezes anualmente
Tráfego do site de relações com investidores	2.000-3.500 visitas mensais

Entera Bio Ltd. (ENTX) - Modelo de negócios: segmentos de clientes

Empresas farmacêuticas e de biotecnologia

A Entera Bio Ltd. tem como alvo as empresas farmacêuticas que desenvolvem biológicas orais e terapias à base de peptídeos. A partir do quarto trimestre 2023, a plataforma de tecnologia da empresa aborda os desafios de entrega de medicamentos para possíveis parceiros.

Tipo de cliente	Tamanho potencial de mercado	Nível de engajamento
Grandes empresas farmacêuticas	US $ 1,2 trilhão de mercado global	Alta colaboração em potencial
Empresas de biotecnologia de tamanho médio	Segmento de mercado de US $ 350 bilhões	Oportunidades de parceria ativa

Instituições de pesquisa

A Entera Bio colabora com centros acadêmicos e de pesquisa focados em tecnologias inovadoras de administração de medicamentos.

• Instituições de pesquisa financiadas pelo NIH
• Laboratórios de Pesquisa Universitária
• Centros especializados de pesquisa de biotecnologia

Pesquisadores clínicos

A plataforma de administração de medicamentos oral da empresa atrai pesquisadores clínicos que desenvolvem novas abordagens terapêuticas.

Foco na pesquisa	Número de pesquisadores em potencial
Terapias à base de peptídeos	Aproximadamente 5.700 pesquisadores globais
Desenvolvimento de Biológicos orais	Estimado 3.200 pesquisadores especializados

Provedores de saúde

Potenciais usuários finais das tecnologias de entrega de medicamentos orais da Entera Bio em ambientes clínicos.

• Hospitais com centros de tratamento avançados
• Clínicas Especiais
• Instalações de tratamento da endocrinologia

Investidores

Investidores interessados ​​em plataformas inovadoras de tecnologia médica.

Categoria de investidores	Potencial de investimento
Empresas de capital de risco	Ponto de investimentos em potencial de US $ 45 milhões
Investidores institucionais focados em biotecnologia	US $ 78 milhões em potencial capacidade de investimento

Entera Bio Ltd. (ENTX) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Entera Bio Ltd. relatou despesas de pesquisa e desenvolvimento de US $ 10,3 milhões.

Ano	Despesas de P&D ($)	Porcentagem do total de despesas
2022	9,7 milhões	62%
2023	10,3 milhões	65%

Investimentos de ensaios clínicos

As despesas de ensaios clínicos para a Entera Bio Ltd. em 2023 totalizaram aproximadamente US $ 6,5 milhões.

• Ensaios clínicos de fase I: US $ 2,1 milhões
• Fase II Ensaios Clínicos: US $ 3,8 milhões
• Estudos pré -clínicos: US $ 0,6 milhão

Manutenção da propriedade intelectual

Os custos anuais de manutenção da propriedade intelectual para 2023 foram de US $ 0,4 milhão.

Categoria IP	Custo ($)
Registro de patentes	250,000
Renovação de patentes	150,000

Pessoal e compensação da equipe científica

As despesas totais de pessoal para 2023 foram de US $ 5,2 milhões.

• Salários da equipe científica: US $ 3,6 milhões
• Compensação da equipe administrativa: US $ 1,6 milhão

Processos de conformidade e aprovação regulatórios

Os custos de conformidade regulatórios para 2023 totalizaram US $ 1,1 milhão.

Categoria de conformidade	Custo ($)
Taxas de envio da FDA	450,000
Consultoria regulatória	350,000
Documentação de conformidade	300,000

Entera Bio Ltd. (ENTX) - Modelo de negócios: fluxos de receita

Potenciais taxas de licenciamento para a tecnologia da plataforma de entrega

A partir de 2024, a Entera Bio não relatou receita específica de licenciamento de sua tecnologia de plataforma de administração de medicamentos oral.

Acordos de colaboração de pesquisa

Parceiro de colaboração	Receita potencial	Status
Ferring Pharmaceuticals	Até US $ 337 milhões em possíveis pagamentos marcantes	Colaboração ativa para o hormônio da paratireóide humana oral

Futuros royalties de produtos farmacêuticos

• Royalties em potencial no EB613 (PTH oral para osteoporose)
• Royalties em potencial no EB612 (PTH oral para hipoparatireoidismo)

Pagamentos marcantes de parcerias estratégicas

A colaboração farmacêutica em Ferring Inclui possíveis pagamentos de marcos estruturados da seguinte forma:

Tipo de marco	Valor potencial de pagamento
Marcos de desenvolvimento	Até US $ 137 milhões
Marcos regulatórios	Até US $ 100 milhões
Marcos comerciais	Até US $ 100 milhões

Vendas potenciais de produtos mediante aprovação regulatória

Não há vendas atuais de produtos relatadas a partir de 2024. Receita futura potencial dependente de aprovações regulatórias para EB613 e 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.