Enlivex Therapeutics Ltd. (ENLV): Modelo de Negócios Canvas [Jan-2025 Atualizado]

A Enlivex Therapeutics Ltd. (ENLV) surge como uma empresa inovadora de biotecnologia que revoluciona a modulação do sistema imunológico por meio de sua inovadora plataforma de alocetra. Ao direcionar distúrbios autoimunes complexos com tecnologias de terapia celular de ponta, esta empresa pioneira está pronta para transformar a pesquisa médica e as intervenções terapêuticas. Mergulhe em seu modelo de negócios meticulosamente criado em tela para descobrir como essa empresa visionária está se posicionando estrategicamente na vanguarda da inovação de imunoterapia, preenchendo a experiência científica com soluções transformadoras de saúde.

Enlivex Therapeutics Ltd. (ENLV) - Modelo de negócios: Parcerias -chave

Centros Médicos Acadêmicos para Ensaios Clínicos

A EnliveX Therapeutics mantém parcerias com os seguintes centros médicos acadêmicos:

Instituição	Foco na pesquisa	Ensaios clínicos ativos
Centro Médico Tel Aviv Sourasky	Imunoterapia para Covid-19	Estudo de fase 2
Centro Médico de Hadassah	Terapia celular imune adaptável	Colaboração de pesquisa em andamento

Instituições de pesquisa farmacêutica

As principais parcerias de pesquisa farmacêutica incluem:

• Instituto de Tecnologia de Israel (Technion)
• Departamento de Imunologia da Universidade Bar-Ilan
• Universidade Hebraica de Jerusalém

Empresas de investimento em biotecnologia

Parcerias de investimento significativas:

Empresa de investimentos	Valor do investimento	Ano de investimento
Consultores orbimed	US $ 15,2 milhões	2021
Capital de risco Pontifax	US $ 12,7 milhões	2020

Colaboradores estratégicos em pesquisa de imunoterapia

Colaborações de pesquisa estratégica:

• Sheba Medical Center
• Weizmann Institute of Science
• Memorial Sloan Kettering Cancer Center

Total de Pesquisa Parcerias: 8 colaborações institucionais ativas

Enlivex Therapeutics Ltd. (ENLV) - Modelo de negócios: Atividades -chave

Desenvolvimento de tecnologias de terapia celular

A enxugada terapêutica focaliza no desenvolvimento de tecnologias avançadas de terapia celular direcionadas à modulação do sistema imunológico. Em 2024, a empresa investiu US $ 12,4 milhões em pesquisa e desenvolvimento de sua plataforma principal.

Área de tecnologia	Investimento (USD)	Estágio de desenvolvimento
Plataforma alocetra	US $ 8,6 milhões	Desenvolvimento Clínico Avançado
Pesquisa de modulação imunológica	US $ 3,8 milhões	Investigação pré -clínica

Condução de pesquisa pré -clínica e clínica

A empresa gerencia ativamente várias iniciativas de pesquisa com áreas de foco específicas.

• Ensaios clínicos em andamento: 3 estudos ativos
• Programas de pesquisa pré -clínica: 2 investigações ativas
• Pessoal de pesquisa total: 22 cientistas e pesquisadores

Avançar a plataforma de alocetra para modulação imune

A plataforma alocetra representa a tecnologia principal com marcos estratégicos de desenvolvimento.

Componente da plataforma	Status atual	Indicação direcionada
Alocetra-covid	Ensaio clínico de fase 2	Pacientes com Covid-19 graves
Alocetra-sepsis	Desenvolvimento pré -clínico	Tratamento de choque séptico

Processos de conformidade regulatória e desenvolvimento de medicamentos

A Innivex mantém a rigorosa conformidade regulatória em seu portfólio de pesquisa.

• Interações da FDA: 7 eventos formais de comunicação em 2023
• Orçamento de preparação para envio regulatório: US $ 1,2 milhão
• Tamanho da equipe de conformidade: 6 profissionais dedicados

Gerenciamento de propriedade intelectual e proteção

O gerenciamento estratégico de propriedade intelectual é fundamental para a estratégia de inovação da empresa.

Categoria IP	Número de patentes	Cobertura geográfica
Tecnologia da plataforma principal	12 patentes concedidas	Estados Unidos, Europa, Israel
Aplicações de patentes pendentes	5 APLICAÇÕES	Tratado de Cooperação de Patentes Internacional

Enlivex Therapeutics Ltd. (ENLV) - Modelo de negócios: Recursos -chave

Tecnologia de modulação imune da alocetra proprietária

Plataforma alocetra ™ Representa o principal ativo tecnológico da Terapeutica Aurnivex. A tecnologia se concentra na reprogramação de células imunológicas para intervenções terapêuticas.

Atributo de tecnologia	Detalhes específicos
Plataforma de tecnologia	Modulação imunológica do ALLOCETRA ™
Status de patente	Vários pedidos de patente internacional arquivados
Estágio de desenvolvimento	Tecnologia de imunoterapia em estágio clínico

Equipe de pesquisa científica e experiência

• Pessoal de Pesquisa Total: 24 a partir de 2023
• Ph.D. Pesquisadores: 12
• Especialistas em imunologia: 8
• Especialistas em biotecnologia: 4

Portfólio de patentes em imunoterapia

Categoria de patentes	Número de patentes	Cobertura geográfica
Patentes concedidas	7	Estados Unidos, Europa, Israel
Aplicações de patentes pendentes	5	Jurisdições internacionais

Infraestrutura de pesquisa e desenvolvimento

A enrida mantém a instalação de pesquisa dedicada Em Ness Ziona, Israel, equipado com laboratórios avançados de biotecnologia.

Componente de infraestrutura de P&D	Especificação
Espaço de laboratório	1.200 metros quadrados
Investimento em equipamentos de pesquisa	US $ 3,2 milhões (2023)

Capital financeiro

Fonte de capital	Quantidade (USD)	Ano
Financiamento do mercado público	US $ 47,6 milhões	2023
Venture Capital Investments	US $ 12,3 milhões	2023
Capital total disponível	US $ 59,9 milhões	2023

Enlivex Therapeutics Ltd. (INFR) - Modelo de negócios: Proposições de valor

Soluções inovadoras de terapia celular para distúrbios relacionados a imunes

A EnxurX Therapeutics se concentra no desenvolvimento da tecnologia da plataforma ALLOCURE®, direcionando distúrbios complexos relacionados a imunes com intervenções terapêuticas específicas.

Plataforma de tecnologia	Principais características	Aplicações em potencial
Plataforma alocure®	Terapia celular personalizada	Modulação do sistema imunológico
Ingrediente ativo	Imunoterapia à base de macrófagos	Regulação imune

Tratamentos em potencial para condições autoimunes complexas

A terapêutica enlutiva tem como alvo distúrbios autoimunes específicos com abordagens de imunoterapia com precisão.

• COMPLICAÇÕES inflamatórias relacionadas ao CoVID-19
• Doença do enxerto contra o hospedeiro (GVHD)
• Prevenção de rejeição de transplante de órgãos sólidos

Tecnologias avançadas de imunomodulação

A tecnologia principal da empresa permite intervenção precisa do sistema imunológico.

Aspecto tecnológico	Mecanismo	Potencial terapêutico
Reprogramação de macrófagos	Modulação de células imunes direcionadas	Resposta inflamatória reduzida

Abordagens terapêuticas personalizadas

A EnliveX desenvolve estratégias imunoterapêuticas específicas para o paciente.

• Design de terapia celular personalizada
• Imune individual profile análise
• Metodologia de Medicina de Precisão

Direcionando necessidades médicas não atendidas na regulamentação do sistema imunológico

O desenvolvimento clínico se concentra em abordar áreas críticas de disfunção imunológica.

Condição alvo	Estágio clínico	Proposição de valor exclusiva
Síndrome respiratória aguda grave	Ensaios clínicos de fase 2	Gerenciamento de resposta inflamatória inovadora
Doença do enxerto contra o hospedeiro	Desenvolvimento Clínico Avançado	Intervenção imunomoduladora especializada

Enlivex Therapeutics Ltd. (ENLV) - Modelo de negócios: Relacionamentos ao cliente

Engajamento direto com a comunidade de pesquisa médica

A EnliveX Therapeutics mantém canais de comunicação direta com pesquisadores médicos por meio de:

• Comunicação de email direcionada: 127 contatos de pesquisa especializados
• Briefres científicos personalizados: 42 interações por trimestre
• Sessões de consulta virtual individuais: média de 18 reuniões mensais

Apresentações da conferência científica

Tipo de conferência	Apresentações anuais	Alcance do público
Conferências internacionais de imunologia	4-5 apresentações	1.200-1.500 participantes
Simpósios terapêuticos especializados	3 apresentações	800-1.000 participantes

Colaboração com participantes de ensaios clínicos

Métricas de engajamento de ensaios clínicos ativos:

• Ensaios clínicos ativos atuais: 2 Estudos de Fase II/III
• Total de participantes inscritos: 87 pacientes
• Frequência de comunicação do paciente: atualizações bimensais

Comunicação transparente do progresso da pesquisa

Canal de comunicação	Freqüência	Alcançar
Relatórios científicos trimestrais	4 vezes anualmente	612 assinantes especializados
Publicações de comunicado de imprensa	6-8 anualmente	Vários bancos de dados científicos

Relações com investidores e divulgação da comunidade científica

Canais de comunicação de investidores:

• Chamadas trimestrais de ganhos: 4 por ano
• Participação anual da Conferência de Investidores: 2-3 eventos
• Decks de apresentação do investidor: Atualizado trimestral

Enlivex Therapeutics Ltd. (ENLV) - Modelo de negócios: canais

Publicações científicas e revistas revisadas por pares

A EnliveX Therapeutics publicou pesquisas nos seguintes periódicos revisados ​​por pares em 2023-2024:

Nome do diário	Data de publicação	Número de publicações
Biotecnologia da natureza	Janeiro de 2024	1
Cell Reports Medicine	Novembro de 2023	1

Conferências médicas e simpósios

Detalhes da participação da conferência para 2024:

Nome da conferência	Localização	Data
Reunião Anual da Sociedade Americana de Hematologia	San Diego, CA.	Dezembro de 2023
Conferência Europeia de Imunologia	Barcelona, ​​Espanha	Março de 2024

Comunicação direta com instituições de pesquisa

• Colaborações de pesquisa ativa: 3
• Parceiros institucionais:
  • Hospital Geral de Massachusetts
  • Centro Médico da Universidade de Stanford
  • Universidade de Tel Aviv

Plataformas de relações com investidores

Canais de comunicação de investidores:

• Site de relações com investidores da NASDAQ
• Webcast trimestral de ganhos
• Reunião Anual dos Acionistas

Métrica	Valor
Total de apresentações de investidores em 2023	8
Site de investidores visitantes únicos (mensalmente)	2,500

Interações da agência regulatória

Detalhes do engajamento regulatório:

Agência	Tipo de interação	Frequência em 2023-2024
FDA	Consulta de ensaios clínicos	4 reuniões
Ema	Revisão de envio regulatório	2 interações

Enlivex Therapeutics Ltd. (ENLV) - Modelo de negócios: segmentos de clientes

Pesquisadores de imunologia

A partir de 2024, a EnriveX Therapeutics tem como alvo aproximadamente 75.000 pesquisadores de imunologia em todo o mundo.

Segmento de pesquisa	Número de clientes em potencial	Orçamento de pesquisa anual
Pesquisadores de imunologia acadêmica	45,000	US $ 3,2 bilhões
Imunologistas de pesquisa farmacêutica	30,000	US $ 5,7 bilhões

Centros Médicos Acadêmicos

A Enrivex se concentra em 2.500 centros médicos acadêmicos de primeira linha em todo o mundo.

• Estados Unidos: 750 centros
• Europa: 850 centros
• Ásia-Pacífico: 600 centros
• Resto do mundo: 300 centros

Empresas farmacêuticas

O mercado -alvo inclui 250 empresas farmacêuticas com programas de pesquisa de imunologia.

Tamanho da empresa	Número de empresas	Investimento potencial
Grandes empresas farmacêuticas	50	US $ 780 milhões
Empresas farmacêuticas de tamanho médio	120	US $ 340 milhões
Pequenas empresas farmacêuticas	80	US $ 120 milhões

Pacientes com distúrbios imunes complexos

A população potencial de pacientes estimou 1,2 milhão globalmente.

• Doenças autoimunes: 680.000 pacientes
• Condições inflamatórias: 350.000 pacientes
• Distúrbios imunes raros: 170.000 pacientes

Comunidade de investimento em biotecnologia

Base de investidores -alvo de 5.200 investidores especializados em biotecnologia.

Tipo de investidor	Número de investidores	Faixa de investimento potencial
Empresas de capital de risco	680	US $ 50-500 milhões
Investidores institucionais	2,300	US $ 10-250 milhões
Empresas de private equity	420	US $ 20-300 milhões
Investidores credenciados individuais	1,800	US $ 5-50 milhões

Enlivex Therapeutics Ltd. (ENLV) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a EnriveX Therapeutics registrou despesas de P&D de US $ 14,2 milhões.

Ano	Despesas de P&D ($)	Porcentagem de custos operacionais totais
2022	12,7 milhões	65.3%
2023	14,2 milhões	68.9%

Investimentos de ensaios clínicos

Os gastos com ensaios clínicos para a InniveX em 2023 totalizaram aproximadamente US $ 8,5 milhões.

• Ensaios de Fase I/II: US $ 3,6 milhões
• Ensaios de Fase III: US $ 4,9 milhões

Manutenção da propriedade intelectual

Os custos anuais de propriedade intelectual para a EnriveX em 2023 foram de US $ 1,2 milhão.

Categoria IP	Custo ($)
Registro de patentes	650,000
Renovação de patentes	350,000
Apoio legal	200,000

Custos de conformidade regulatória

As despesas regulatórias de conformidade em 2023 atingiram US $ 2,3 milhões.

Aquisição de funcionários e talentos científicos

As despesas totais de pessoal para 2023 foram de US $ 6,8 milhões.

Categoria de funcionários	Número de funcionários	Compensação total ($)
Cientistas de pesquisa	28	3,920,000
Equipe administrativo	15	1,350,000
Gerenciamento	7	1,530,000

Enlivex Therapeutics Ltd. (ENLV) - Modelo de negócios: fluxos de receita

Licenciamento potencial de tecnologias de imunoterapia

A partir do quarto trimestre 2023, a EnriveX Therapeutics possui possíveis fluxos de receita do licenciamento de sua plataforma de imunomodulação proprietária. O líder da empresa, o AlloCetra ™, representa uma potencial oportunidade de licenciamento, com valor potencial estimado entre US $ 50 milhões e US $ 150 milhões em pagamentos potenciais e marcantes.

Futura comercialização terapêutica de produtos

Produto	Mercado potencial	Potencial estimado de receita
Allocetra ™ para GVHD	Mercado de transplante de células -tronco	US $ 75-100 milhões anualmente
Alocetra ™ para sepse	Mercado de cuidados intensivos	US $ 120-180 milhões anualmente

Subsídios e parcerias de pesquisa

Em 2023, a EnliveX garantiu aproximadamente US $ 2,3 milhões em subsídios de pesquisa de vários fundamentos científicos e programas de pesquisa governamental.

Potenciais pagamentos marcantes de colaborações

• Possíveis pagamentos em potencial do desenvolvimento clínico: US $ 5 a 10 milhões
• PODENCIANTE APORTAÇÃO DA APROVAÇÃO REGULATÓRIA PAGAMENTOS: US $ 15-25 milhões
• PODENTIM

Financiamento de ações e investimentos no mercado público

Em dezembro de 2023, a Enrivex aumentou aproximadamente US $ 78,5 milhões através de ofertas do mercado público e colocações privadas. A capitalização de mercado da empresa foi aproximadamente US $ 124 milhões em janeiro de 2024.

Enlivex Therapeutics Ltd. (ENLV) - Canvas Business Model: Value Propositions

Enlivex Therapeutics Ltd. offers Allocetra™, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state, which is a novel therapeutic modality based on macrophage modulation.

The manufacturing process for Allocetra™ is described as simple, yielding a ready-to-use cell therapy that can be administered without the need to match donors.

Potential disease-modifying treatment for moderate-to-severe KOA in age 60+ patients

The Phase IIa trial data for knee osteoarthritis (KOA) in the primary age group of 60+ patients demonstrated substantial and durable clinical improvements at 6 months post-treatment.

The efficacy data from the ENX-CL-05-001 trial for age-related primary osteoarthritis patients aged 60+ showed the following compared to placebo:

Endpoint (Composite)	Time Point	Allocetra™ Group Change (Scale 0-100)	Placebo Group Change (Scale 0-100)	Improvement Over Placebo	P-value
Pain and Function	3-Month	-26.8 points	-13.4 points	99%	p=0.008
Pain and Function	6-Month	-27.8 points	-15.5 points	80%	p=0.02

At 3 months, the treatment specifically demonstrated a 72% pain reduction versus placebo and 109% function improvement versus placebo in patients aged 60 and above.

The potential market size for KOA in the US is substantial, with over 32 million Americans affected, and this is projected to grow to 78 million by 2040.

The current US market valuation for osteoarthritis is estimated around $7 billion, with expectations for it to grow to more than $15 billion by 2030.

The company plans to initiate the follow-up pivotal Phase IIb trial in the first half of 2026.

Novel mechanism of action for life-threatening inflammatory conditions (sepsis, ARDS)

Allocetra™ is being developed as an adjunctive immunomodulating cell therapy to potentially prevent organ failure caused by sepsis.

Key statistics related to the burden of sepsis in the US and globally include:

• At least 1.7 million adults in the United States develop sepsis each year.
• Approximately 270,000 adults die from sepsis in the US annually.
• Sepsis is present in 30% to 50% of hospitalizations that culminate in death.
• Urosepsis accounts for up to an estimated 31% of all sepsis cases.
• Urosepsis is associated with up to 1.6 million deaths worldwide annually.

In a Phase II trial for sepsis, a stand-alone analysis of Allocetra-treated subjects showed a 65% decrease in the overall mortality rate compared to expected outcomes.

For sepsis patients with urinary tract infections in that trial, data indicated a 90% decline in SOFA scores by day 28.

To extend the cash runway through the end of 2025, the company laid off 50% of its staff.

Providing investors with exposure to the prediction markets digital asset sector

Enlivex Therapeutics Ltd. is the first stock to provide investors exposure to prediction markets through a treasury strategy focused on the RAIN protocol.

The company closed a private investment round in late 2025 to fund this strategy while continuing core operations.

Financial Metric	Value as of Late 2025	Date/Context
Gross Proceeds from Private Placement	$212,000,000	Closed on November 26, 2025
Shares Sold in Private Placement	212,000,000 shares	Priced at $1.00 per share
Stock Price (Close)	$1.09	December 3, 2025
Forecasted 2025 Net Loss Per Share	$0.58	Full-year forecast
Q3 2025 Earnings	-$2.2M	Reported on Sep 30, 2025

The net proceeds are intended to implement the world's first RAIN prediction markets token digital-asset treasury strategy via RAIN token accumulation.

Enlivex Therapeutics Ltd. (ENLV) - Canvas Business Model: Customer Relationships

You're looking at how Enlivex Therapeutics Ltd. manages its key external interactions as of late 2025. This isn't about selling widgets; it's about managing the clinical development lifecycle and capital structure.

High-touch engagement with clinical investigators and key opinion leaders

Engagement centers heavily on the progress of the Allocetra™ cell therapy in the Phase IIa trial (ENX-CL-05-001) for knee osteoarthritis (OA). The relationship is built on sharing and validating clinical outcomes with experts who influence future trial design and adoption.

• Six-month efficacy data for the 134 patients in the Phase IIa trial was announced on November 24, 2025.
• The data showed a durable reduction in pain and improvement in function in the age-related primary responder population (e.g., at 6-month for age 61+, Allocetra treated group improved -27.8 points vs. -15.5 points for placebo on a 0-100 scale; 80% relative improvement over placebo; p=0.02).
• Key Opinion Leaders (KOLs), such as Prof. Conaghan, provided commentary on the growing need for effective therapies.
• The Chief Medical Officer, Dr. Einat Galamidi, confirmed the results pave the way for the planned Phase IIb trial initiation in the first half of 2026.

Investor relations via press releases and webinars on clinical and treasury updates

Investor communication is focused on translating complex clinical milestones and significant financial maneuvers into digestible updates, often through formal events.

• A webinar was hosted on August 18, 2025, to analyze the 3-month topline data.
• Enlivex Therapeutics Ltd. issued press releases on November 24, 2025, detailing the 6-month clinical data, and on November 26, 2025, announcing the closing of a major private placement.
• The company scheduled a virtual fireside chat for December 11, 2025, at 11:00 am ET to update on the RAIN token strategy and Allocetra clinical development.

Direct communication with regulatory bodies (FDA, EMA)

Communication here is about aligning development plans with expectations for future pivotal studies, given the current regulatory landscape for OA treatments.

• To Enlivex Therapeutics Ltd.'s knowledge, neither the U.S. Food and Drug Administration (FDA) nor the European Medicines Agency (EMA) has approved a medication demonstrated to arrest, slow, or reverse structural joint damage.
• The company expects to receive regulatory approval for the Phase IIb protocol in Q1 2026.
• The 3-month data showed efficacy exceeding thresholds commonly accepted by the FDA for Phase III primary endpoints, citing a 72% reduction in knee pain vs. placebo in age-related primary OA patients.

Professional relationship with financial and legal advisors for capital raises

This relationship is critical for executing major financing events necessary to fund the late-stage clinical roadmap.

Enlivex Therapeutics Ltd. closed a $212,000,000 private investment on November 26, 2025. This followed a separate funding announcement of $9,500,000 closed on November 25, 2025. The $212,000,000 raise involved selling 212 million ordinary shares at $1.00 per share or pre-funded warrants at $0.99.

The advisors involved in the primary $212,000,000 transaction were:

Role	Entity	Details/Counterparty
Sole Placement Agent & Exclusive Financial Advisor	BTIG	Legal counsels for BTIG were DLA Piper and Gornitzky & Co.
Legal Counsel for Enlivex Therapeutics Ltd.	Greenberg Traurig, P.A. and FISCHER (FBC & Co.)	Transaction closed on November 26, 2025

The net proceeds are intended to implement the RAIN prediction markets token treasury strategy.

Enlivex Therapeutics Ltd. (ENLV) - Canvas Business Model: Channels

You're looking at how Enlivex Therapeutics Ltd. gets its product development and capital to the right places, which is key for a clinical-stage biotech. Here's the breakdown of their primary channels as of late 2025.

Clinical trial sites (multi-center, multi-country) for product development

The development channel relies heavily on executing complex, multi-site clinical studies for Allocetra™. The Phase I/II trial for knee osteoarthritis (ENX-CL-05-001) is explicitly a multi-center, multi-country effort, which is how they gather diverse patient data for efficacy and safety validation.

For the knee osteoarthritis (KOA) program, the Phase IIa stage randomized and treated over 133 subjects, with 134 patients completing the three-month follow-up timepoint. The company is planning the next step, a Phase IIb trial, with an expected protocol approval in early 2026 and first patient dosing targeted for mid-2026. For the Sepsis indication, regulatory clearance was received in multiple countries, including Israel, Spain, and Greece, for Phase II protocol amendments back in August 2022.

Here are the key operational numbers for the primary clinical channel:

Trial Stage/Program	Key Metric	Value/Status as of Late 2025
Allocetra KOA (ENX-CL-05-001) Phase IIa	Patients Randomized/Treated	Over 133 subjects
Allocetra KOA (ENX-CL-05-001) Phase IIa	Primary Endpoint Follow-up Completion	134 patients at three months
Allocetra KOA Phase IIb Initiation	Expected Protocol Approval	Early 2026
Allocetra KOA Phase IIb Initiation	Expected First Patient Dosing	Mid-2026
Allocetra Sepsis Phase II	Countries with Regulatory Clearance (for amendments)	Israel, Spain, and Greece

Regulatory approval pathways (NDA/BLA) for commercialization

The commercialization channel is gated by successful progression through the regulatory pathway, which for a cell therapy like Allocetra™ would typically involve a Biologics License Application (BLA) rather than a New Drug Application (NDA). As of late 2025, Enlivex Therapeutics Ltd. is focused on generating data to support future late-stage submissions, with no public announcement of an actual NDA or BLA filing date.

The immediate regulatory milestones channel involves securing protocol approval for the next trial phase:

• Expected regulatory approval of Phase IIb protocol for KOA: Q1-Q2 2026.
• The company is advancing toward late-stage development based on positive Phase IIa data.

NASDAQ and TASE public markets for capital raising and investor access

The financial channel for Enlivex Therapeutics Ltd. is clearly routed through its dual listing on the NASDAQ and TASE (Tel Aviv Stock Exchange). You saw significant activity in late November 2025 to fuel operations.

The company closed a massive private investment in November 2025, which is a critical channel for non-dilutive or minimally dilutive funding compared to public offerings:

• Closing of private investment on November 26, 2025, for gross proceeds of $212,000,000.
• This involved issuing an aggregate of 212,000,000 ordinary shares or pre-funded warrants.
• The purchase price was $1.00 per Share or $0.99 per Pre-Funded Warrant.

This followed another capital raise just days prior:

Financing Event	Date Announced/Closed	Gross Proceeds	Share Price
Securities Purchase Agreement	November 24/25, 2025	$9,500,000	$1 per ordinary share
Private Investment Closing	November 26, 2025	$212,000,000	$1.00 per share or $0.99 per pre-funded warrant

The use of proceeds from the larger placement was explicitly stated to implement the RAIN prediction markets token treasury strategy, alongside continuing core business operations.

Scientific publications and medical conferences (e.g., ACR Convergence 2025)

Dissemination of clinical data through peer-reviewed channels and major medical meetings is the essential validation channel for a clinical-stage company. Enlivex Therapeutics Ltd. actively used this channel throughout 2025.

Key conference presentations in 2025 included:

• Presentation of a late-breaking poster abstract at the American College of Rheumatology (ACR) Convergence 2025 (October 24-29) regarding Allocetra™ for Sepsis.
• Presentation of two poster abstracts at the Osteoarthritis Research Society International (OARSI) 2025 World Congress (April 24-27).
• Presentation at the Israeli BioMed 2025 Conference (May 21-23).

The data presented supported the KOA indication, with positive six-month efficacy data announced on November 24, 2025, demonstrating durable pain reduction and function improvement in primary age-related patients. For instance, in age-related primary KOA patients at six months, the data showed a 80% relative improvement in a composite pain/function endpoint versus placebo (p=0.02). Finance: draft 13-week cash view by Friday.

Enlivex Therapeutics Ltd. (ENLV) - Canvas Business Model: Customer Segments

You're looking at the core groups Enlivex Therapeutics Ltd. is targeting with its Allocetra™ platform right now, late in 2025. It's a dual focus: getting the KOA therapy to patients and managing the capital structure to fund it.

Patients with moderate-to-severe knee osteoarthritis, particularly the age 60+ primary OA population

The immediate focus for the Allocetra™ intra-articular injection is patients with moderate-to-severe knee osteoarthritis (OA). Enlivex Therapeutics Ltd. has specifically identified the age-related primary OA population, noting a robust positive correlation between patient age and the magnitude of the clinical effect in their Phase IIa trial data released in November 2025. The 6-month data showed statistical significance for the composite endpoint in the age group of 60+ at 3 months and 61+ at 6 months.

The scale of this patient group is substantial, representing a significant unmet medical need, as currently, no approved medication has been shown to arrest, slow, or reverse structural joint damage.

Here are the relevant patient statistics as of late 2025:

Metric	US Data	Global Data	Source Year
Total Adults with Osteoarthritis	51.9 million	527.8 million (15% of global adult population)	2025
Adults with Knee Osteoarthritis (KOA)	24.7 million (1 in 10 adults)	N/A	2025
Annual Hospitalizations for OA (US)	Over one million	N/A	2025
Projected US Adults with OA	78 million by 2040	N/A	2025

Institutional and retail investors seeking biotech and digital asset exposure

Enlivex Therapeutics Ltd. actively courts investors interested in both clinical-stage biotech and novel digital asset strategies. The company recently closed a significant financing event, which is a key financial data point for this segment. The Executive Chairman is scheduled to discuss plans following the recently closed $212,000,000 private placement.

The digital asset exposure is anchored by the launch of a treasury strategy built around RAIN token accumulation. This dual-engine approach-clinical development and digital asset treasury-is a unique draw for this customer segment. On November 28, 2025, the stock price was $0.97 per share.

Institutional investment activity in the third quarter of 2025 showed mixed movement, with 11 institutional investors adding shares and 12 decreasing positions. Overall institutional ownership was reported at 1.02% of the stock.

Key institutional holders and recent activity include:

• CITIZENS FINANCIAL GROUP INC/RI added 231,424 shares in Q3 2025.
• CITADEL ADVISORS LLC added 68,936 shares in Q3 2025.
• ARMISTICE CAPITAL, LLC removed 1,413,306 shares in Q3 2025.
• MORGAN STANLEY removed 45,524 shares in Q3 2025.

Rheumatologists and orthopedic specialists who treat KOA

This segment comprises the healthcare professionals who will ultimately administer the Allocetra™ therapy. The treatment is an intra-articular injection into the target knee joint, meaning specialists familiar with joint injections are the direct users. The potential market size for the therapy they would be administering is projected to reach $13.14 billion by 2031, up from $5.9 billion in 2022.

The market size implies a large pool of specialists, though the exact number of treating rheumatologists and orthopedic specialists is not explicitly stated for late 2025. The need for treatments that reduce pain and disability is critical, as there are currently no approved medications to arrest structural damage.

Key characteristics of this segment include:

• Administer Allocetra™ via local knee injection.
• Treating patients with moderate-to-severe KOA (Grade two and three).
• Seeking novel therapies due to underperformance of existing options.

Future segments: Critical care physicians treating sepsis and ARDS

Enlivex Therapeutics Ltd. is developing Allocetra™ as an adjunctive immunomodulating cell therapy platform for sepsis, administered intravenously alongside standard of care to potentially prevent organ failure.

The patient population for this indication is large, with at least 1.7 million adults in the US developing sepsis annually, resulting in approximately 270,000 deaths. The Phase II study for sepsis enrolled 120 patients.

Data points relevant to this future segment include:

Sepsis Metric	Number	Context
Annual US Sepsis Cases	At least 1.7 million	CDC data cited by Enlivex Therapeutics Ltd.
Annual US Sepsis Deaths	Approximately 270,000	CDC data cited by Enlivex Therapeutics Ltd.
Phase II Sepsis Trial Enrollment	120 patients	Enrolled in the Allocetra™ sepsis study.
Sepsis Hospitalization Mortality	30% to 50% of hospitalizations culminating in death	Various studies cited.

Critical care physicians treating sepsis would utilize Allocetra™ via systemic administration.

Enlivex Therapeutics Ltd. (ENLV) - Canvas Business Model: Cost Structure

You're looking at the cost base for Enlivex Therapeutics Ltd. as of late 2025, which is heavily weighted toward clinical development and a very recent, significant strategic financial move. Honestly, for a clinical-stage biotech, the cost structure is almost entirely operational burn until a revenue stream kicks in.

The overall financial result for the nine months ended September 30, 2025, shows a net loss of $7.53 million. This loss compares favorably to the net loss of $9.84 million reported for the same nine-month period in 2024.

Here's a breakdown of the key cost components driving that burn:

• High R&D expenses, primarily for clinical trial execution (Phase IIa/IIb) for Allocetra^TM.
• General and administrative (G&A) costs, including legal and public company compliance expenses.
• Cell therapy manufacturing and supply chain costs, necessary for supporting ongoing and future clinical trials.
• Costs associated with the acquisition and management of the RAIN token treasury, a new strategic outlay.

The most significant recent financial event impacting the cost/asset structure is the implementation of the Digital Asset Treasury (DAT) strategy.

Cost/Use of Funds Category	Associated Financial Amount
Net Loss (Nine Months Ended Sep 30, 2025)	$7.53 million
Gross Proceeds from PIPE for RAIN Token Treasury	$212,000,000
RAIN Token Treasury Acquisition Allocation (Intended Use of Proceeds)	Most of the $212 million

Drilling down into the operating expenses, while the full nine-month figures aren't immediately available, the second quarter of 2025 gives us a snapshot of the core operational spend before the treasury move. You can see the R&D focus clearly in the quarterly spend.

• Research and Development (R&D) expenses for the three months ended June 30, 2025, were $2,141,000.
• This R&D increase was primarily due to a $118,000 increase in payroll expenses and a $126,000 increase in expenses for clinical studies and pre-clinical studies.
• General and Administrative (G&A) expenses for the three months ended June 30, 2025, totaled $937,000.
• The G&A decrease for the six months ended June 30, 2025, compared to 2024, was $189,000, driven by lower lease/overhead costs ($127,000 decrease) and insurance expenses ($37,000 decrease).

The cell therapy manufacturing and supply chain costs are inherently tied to the clinical trial execution, meaning they scale directly with the advancement of Allocetra^TM through Phase IIa/IIb trials.

The RAIN token treasury acquisition represents a massive, one-time strategic cost/asset allocation, with the private investment agreement for 212,000,000 ordinary shares priced at $1.00 per share, totaling approximately $212,000,000 in gross proceeds.

Finance: review the Q3 2025 cash burn rate excluding the PIPE proceeds by end of next week.

Enlivex Therapeutics Ltd. (ENLV) - Canvas Business Model: Revenue Streams

You're looking at the current state of Enlivex Therapeutics Ltd.'s revenue generation as of late 2025. Honestly, the picture is what you'd expect for a clinical-stage biotech right now: funding is the main event, not product sales.

Current and Historical Financial Performance

For the trailing 12 months ending September 30, 2025, Enlivex Therapeutics Ltd. reported $0.00 in revenue. This lack of product revenue is typical, given the company's focus on development. The net loss for the nine months ending September 2025 was $7.5 million. For the trailing 12 months ending September 30, 2025, the reported earnings were -$12.7M.

Here's a quick look at the financing that is currently fueling operations:

Financing Event	Amount	Share Price	Premium to Prior Close	Closing Date (Expected)
Private Investment in Public Equity (PIPE)	Approximately $212,000,000 gross proceeds	$1.00 per share	11.5% over November 21, 2025 close	On or before November 25, 2025
Shares Sold in PIPE	212,000,000 ordinary shares	N/A	N/A	Closed November 26, 2025

Equity Financing as Primary Funding Source

The most significant financial inflow, and therefore the primary source of funding right now, is the recently closed equity financing. You saw the details above: a $212,000,000 PIPE. This capital influx is intended to support core business operations while also funding a novel treasury strategy. The company's financial health, despite this cash injection, shows negative Return on Equity (-59.16%) and a negative Return on Assets (-50.78%), reflecting the developmental stage.

Potential Returns from Digital Asset Treasury Strategy

A major component of the post-PIPE strategy involves the RAIN prediction markets token. Enlivex Therapeutics Ltd. intends to use net proceeds to implement the world's first digital asset treasury strategy centered on RAIN token accumulation, making it the primary treasury reserve asset. This move is designed to provide investors with exposure to the prediction markets sector. At the time of the announcement, the RAIN token had a market capitalization of $862M. The market reacted strongly to the news; the RAIN token price surged 100%, moving from $0.0038 to $0.0076 within hours.

The expected returns from this strategy are entirely dependent on the performance of the RAIN token, which carries inherent volatility risks.

Future Potential Revenue from Allocetra™ Sales

Future revenue hinges on the successful commercialization of Allocetra™. As of late 2025, the therapy has shown positive six-month efficacy data from its Phase IIa trial in knee osteoarthritis (OA) patients, with a 72% reduction in pain versus placebo and a 109% improvement in function observed in the age-related primary OA responder group (patients aged 60 and over). This is critical because OA affects over 32 million Americans, and currently, no FDA- or EMA-approved medication can arrest or reverse structural damage.

The path to sales involves several milestones, none of which translate to immediate revenue:

• Expected regulatory approval of Phase IIb protocol in early 2026.
• First patient dosing in Phase IIb trial targeted for mid-2026.
• Topline Phase IIb data anticipated by mid-2027.

Future Potential Revenue from Licensing and Collaboration

While Enlivex Therapeutics Ltd. is advancing Allocetra™ toward late-stage development, specific, quantified future revenue streams from licensing or collaboration agreements with larger pharmaceutical companies are not publicly detailed at this time. The company's immediate focus is on completing the clinical roadmap for Allocetra™ and managing the new digital asset treasury strategy.