Enlivex Therapeutics Ltd. (ENLV): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

Enlivex Therapeutics Ltd. (ENLV) surge como una innovadora empresa de biotecnología que revoluciona la modulación del sistema inmunitario a través de su innovadora plataforma Asignra. Al dirigirse a trastornos autoinmunes complejos con tecnologías de terapia celular de vanguardia, esta empresa pionera está preparada para transformar la investigación médica y las intervenciones terapéuticas. Sumérgete en su lienzo de modelo de negocio meticulosamente elaborado para descubrir cómo esta compañía visionaria se está posicionando estratégicamente a la vanguardia de la innovación de inmunoterapia, uniendo la experiencia científica con soluciones transformadoras de atención médica.

Enlivex Therapeutics Ltd. (INNV) - Modelo de negocio: asociaciones clave

Centros médicos académicos para ensayos clínicos

Enlivex Therapeutics mantiene asociaciones con los siguientes centros médicos académicos:

Institución	Enfoque de investigación	Ensayos clínicos activos
Tel Aviv Surasky Medical Center	Inmunoterapia para Covid-19	Prueba de fase 2
Centro Médico Hadassah	Terapia adaptativa de células inmunes	Colaboración de investigación en curso

Instituciones de investigación farmacéutica

Las asociaciones clave de investigación farmacéutica incluyen:

• Instituto de Tecnología de Israel (Technion)
• Departamento de Inmunología de la Universidad de Bar-Ilan
• Universidad Hebrea de Jerusalén

Empresas de inversión de biotecnología

Asociaciones de inversión significativas:

Firma de inversión	Monto de la inversión	Año de inversión
Orbimed Advisors	$ 15.2 millones	2021
Capital de riesgo de Pontifax	$ 12.7 millones	2020

Colaboradores estratégicos en investigación de inmunoterapia

Colaboraciones de investigación estratégica:

• Centro Médico de SABA
• Instituto de Ciencia Weizmann
• Memorial Sloan Kettering Cancer Center

Asociaciones totales de investigación: 8 colaboraciones institucionales activas

Enlivex Therapeutics Ltd. (INNV) - Modelo de negocio: actividades clave

Desarrollo de tecnologías de terapia celular

Enlivex Therapeutics se centra en desarrollar tecnologías avanzadas de terapia celular dirigida a la modulación del sistema inmunitario. A partir de 2024, la compañía ha invertido $ 12.4 millones en investigación y desarrollo de su plataforma central.

Área tecnológica	Inversión (USD)	Etapa de desarrollo
Plataforma de asignación	$ 8.6 millones	Desarrollo clínico avanzado
Investigación de modulación inmune	$ 3.8 millones	Investigación preclínica

Realización de investigaciones preclínicas y clínicas

La compañía administra activamente múltiples iniciativas de investigación con áreas de enfoque específicas.

• Ensayos clínicos en curso: 3 estudios activos
• Programas de investigación preclínica: 2 investigaciones activas
• Total de personal de investigación: 22 científicos e investigadores

Avance de la plataforma Allocetra para la modulación inmune

La plataforma Allocetra representa la tecnología central con hitos de desarrollo estratégico.

Componente de la plataforma	Estado actual	Indicación dirigida
Alocetra-covid	Ensayo clínico de fase 2	Pacientes severos de Covid-19
Alocetra-sepsis	Desarrollo preclínico	Tratamiento de choque séptico

Cumplimiento regulatorio y procesos de desarrollo de fármacos

Enlivex mantiene un cumplimiento regulatorio riguroso en su cartera de investigación.

• Interacciones de la FDA: 7 eventos de comunicación formal en 2023
• Presupuesto de preparación de presentación regulatoria: $ 1.2 millones
• Tamaño del equipo de cumplimiento: 6 profesionales dedicados

Gestión y protección de la propiedad intelectual

La gestión estratégica de la propiedad intelectual es fundamental para la estrategia de innovación de la empresa.

Categoría de IP	Número de patentes	Cobertura geográfica
Tecnología de plataforma central	12 patentes otorgadas	Estados Unidos, Europa, Israel
Aplicaciones de patentes pendientes	5 aplicaciones	Tratado de cooperación de patentes internacionales

Enlivex Therapeutics Ltd. (Enlv) - Modelo de negocio: recursos clave

Tecnología de modulación inmune de allocetra patentada

Plataforma Allocetra ™ Representa el activo tecnológico central de la terapéutica de Enlivex. La tecnología se centra en la reprogramación de células inmunes para intervenciones terapéuticas.

Atributo tecnológico	Detalles específicos
Plataforma tecnológica	Modulación inmune Allocetra ™
Estado de patente	Múltiples solicitudes internacionales de patentes presentadas
Etapa de desarrollo	Tecnología de inmunoterapia de etapa clínica

Equipo de investigación científica y experiencia

• Personal de investigación total: 24 a partir de 2023
• Doctor en Filosofía. Investigadores: 12
• Especialistas de inmunología: 8
• Expertos en biotecnología: 4

Cartera de patentes en inmunoterapia

Categoría de patente	Número de patentes	Cobertura geográfica
Patentes concedidas	7	Estados Unidos, Europa, Israel
Aplicaciones de patentes pendientes	5	Jurisdicciones internacionales

Infraestructura de investigación y desarrollo

Enlivex mantiene un Instalación de investigación dedicada En Ness Ziona, Israel, equipado con laboratorios de biotecnología avanzados.

Componente de infraestructura de I + D	Especificación
Espacio de laboratorio	1.200 metros cuadrados
Inversión en equipos de investigación	$ 3.2 millones (2023)

Capital financiero

Fuente del capital	Cantidad (USD)	Año
Financiación del mercado público	$ 47.6 millones	2023
Inversiones de capital de riesgo	$ 12.3 millones	2023
Capital total disponible	$ 59.9 millones	2023

Enlivex Therapeutics Ltd. (Enlv) - Modelo de negocio: propuestas de valor

Soluciones innovadoras de terapia celular para trastornos inmunes

Enlivex Therapeutics se centra en el desarrollo de la tecnología de plataforma Allocure®, dirigida a trastornos complejos relacionados con el inmune con intervenciones terapéuticas específicas.

Plataforma tecnológica	Características clave	Aplicaciones potenciales
Plataforma Allocure®	Terapia celular personalizada	Modulación del sistema inmunitario
Ingrediente activo	Inmunoterapia basada en macrófagos	Regulación inmune

Tratamientos potenciales para afecciones autoinmunes complejas

La Terapéutica de Enlivex se dirige a trastornos autoinmunes específicos con enfoques de inmunoterapia de precisión.

• Complicaciones inflamatorias relacionadas con Covid-19
• Enfermedad de injerto contra huésped (GVHD)
• Prevención de rechazo de trasplante de órganos sólidos

Tecnologías avanzadas de inmunomodulación

La tecnología central de la compañía permite una intervención precisa del sistema inmune.

Aspecto tecnológico	Mecanismo	Potencial terapéutico
Reprogramación de macrófagos	Modulación de células inmunes dirigidas	Respuesta inflamatoria reducida

Enfoques terapéuticos personalizados

Enlivex desarrolla estrategias inmunoterapéuticas específicas del paciente.

• Diseño de terapia celular personalizado
• Inmune individual profile análisis
• Metodología de medicina de precisión

Dirigir las necesidades médicas no satisfechas en la regulación del sistema inmune

El desarrollo clínico se centra en abordar las áreas críticas de disfunción inmune.

Condición objetivo	Estadio clínico	Propuesta de valor única
Síndrome de distrés respiratorio agudo	Ensayos clínicos de fase 2	Gestión innovadora de respuesta inflamatoria
Enfermedad de injerto contra huésped	Desarrollo clínico avanzado	Intervención inmunomoduladora especializada

Enlivex Therapeutics Ltd. (INNV) - Modelo de negocio: relaciones con los clientes

Compromiso directo con la comunidad de investigación médica

Enlivex Therapeutics mantiene canales de comunicación directa con investigadores médicos a través de:

• Comunicaciones de correo electrónico específicas: 127 contactos de investigación especializados
• Informes científicos personalizados: 42 interacciones por trimestre
• Sesiones de consulta virtual individual: promedio 18 reuniones mensuales

Presentaciones de conferencias científicas

Tipo de conferencia	Presentaciones anuales	Alcance de la audiencia
Conferencias internacionales de inmunología	4-5 presentaciones	1.200-1,500 asistentes
Simposios terapéuticos especializados	3 presentaciones	800-1,000 participantes

Colaboración con participantes de ensayos clínicos

Métricas de compromiso de ensayos clínicos activos:

• Ensayos clínicos activos actuales: estudios de 2 fase II/III
• Participantes totales inscritos: 87 pacientes
• Frecuencia de comunicación del paciente: actualizaciones bimensuales

Comunicación transparente del progreso de la investigación

Canal de comunicación	Frecuencia	Alcanzar
Informes científicos trimestrales	4 veces anualmente	612 suscriptores especializados
Publicaciones de comunicaciones de prensa	6-8 anualmente	Bases de datos científicas múltiples

Relaciones con inversores y alcance de la comunidad científica

Canales de comunicación de inversores:

• Llamadas de ganancias trimestrales: 4 por año
• Participación anual de la conferencia de inversores: 2-3 eventos
• Macetas de presentación del inversor: Actualizado trimestralmente

Enlivex Therapeutics Ltd. (Enlv) - Modelo de negocio: canales

Publicaciones científicas y revistas revisadas por pares

Enlivex Therapeutics ha publicado investigaciones en las siguientes revistas revisadas por pares en 2023-2024:

Nombre del diario	Fecha de publicación	Número de publicaciones
Biotecnología de la naturaleza	Enero de 2024	1
Medicina de informes celulares	Noviembre de 2023	1

Conferencias y simposios médicos

Detalles de participación de la conferencia para 2024:

Nombre de conferencia	Ubicación	Fecha
Reunión anual de la Sociedad Americana de Hematología	San Diego, CA	Diciembre de 2023
Conferencia europea de inmunología	Barcelona, ​​España	Marzo de 2024

Comunicación directa con instituciones de investigación

• Colaboraciones de investigación activa: 3
• Socios institucionales:
  • Hospital General de Massachusetts
  • Centro Médico de la Universidad de Stanford
  • Universidad de Tel Aviv

Plataformas de relaciones con los inversores

Canales de comunicación de inversores:

• Sitio web de Nasdaq Investor Relations
• Transmisión web de ganancias trimestrales
• Reunión anual de accionistas

Métrico	Valor
Presentaciones totales de inversores en 2023	8
Sitio web de inversores Visitantes únicos (mensuales)	2,500

Interacciones de la agencia reguladora

Detalles de participación regulatoria:

Agencia	Tipo de interacción	Frecuencia en 2023-2024
FDA	Consulta de ensayos clínicos	4 reuniones
EMA	Revisión de presentación regulatoria	2 interacciones

Enlivex Therapeutics Ltd. (INNV) - Modelo de negocio: segmentos de clientes

Investigadores de inmunología

A partir de 2024, la terapéutica de Enlivex se dirige a aproximadamente 75,000 investigadores de inmunología a nivel mundial.

Segmento de investigación	Número de clientes potenciales	Presupuesto de investigación anual
Investigadores de inmunología académica	45,000	$ 3.2 mil millones
Inmunólogos de investigación farmacéutica	30,000	$ 5.7 mil millones

Centros médicos académicos

Enlivex se centra en 2.500 centros médicos académicos de primer nivel en todo el mundo.

• Estados Unidos: 750 centros
• Europa: 850 centros
• Asia-Pacífico: 600 centros
• Resto del mundo: 300 centros

Compañías farmacéuticas

El mercado objetivo incluye 250 compañías farmacéuticas con programas de investigación de inmunología.

Tamaño de la empresa	Número de empresas	Inversión potencial
Grandes compañías farmacéuticas	50	$ 780 millones
Compañías farmacéuticas de tamaño mediano	120	$ 340 millones
Pequeñas compañías farmacéuticas	80	$ 120 millones

Pacientes con trastornos inmunes complejos

La población potencial de los pacientes estimada en 1,2 millones a nivel mundial.

• Enfermedades autoinmunes: 680,000 pacientes
• Condiciones inflamatorias: 350,000 pacientes
• Trastornos inmunes raros: 170,000 pacientes

Comunidad de inversión en biotecnología

Base de inversores objetivo de 5.200 inversores de biotecnología especializados.

Tipo de inversor	Número de inversores	Rango de inversión potencial
Empresas de capital de riesgo	680	$ 50-500 millones
Inversores institucionales	2,300	$ 10-250 millones
Empresas de capital privado	420	$ 20-300 millones
Inversores acreditados individuales	1,800	$ 5-50 millones

Enlivex Therapeutics Ltd. (Enlv) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Enlivex Therapeutics reportó gastos de I + D de $ 14.2 millones.

Año	Gastos de I + D ($)	Porcentaje de costos operativos totales
2022	12.7 millones	65.3%
2023	14.2 millones	68.9%

Inversiones de ensayos clínicos

Los gastos de ensayos clínicos para Enlivex en 2023 totalizaron aproximadamente $ 8.5 millones.

• Pruebas de fase I/II: $ 3.6 millones
• Pruebas de fase III: $ 4.9 millones

Mantenimiento de la propiedad intelectual

Los costos anuales de propiedad intelectual para Enlivex en 2023 fueron de $ 1.2 millones.

Categoría de IP	Costo ($)
Presentación de patentes	650,000
Renovación de patente	350,000
Apoyo legal	200,000

Costos de cumplimiento regulatorio

Los gastos de cumplimiento regulatorio para 2023 alcanzaron los $ 2.3 millones.

Adquisición de personal y talento científico

Los gastos totales de personal para 2023 fueron de $ 6.8 millones.

Categoría de empleado	Número de empleados	Compensación total ($)
Investigar científicos	28	3,920,000
Personal administrativo	15	1,350,000
Gestión	7	1,530,000

Enlivex Therapeutics Ltd. (Enlv) - Modelo de negocio: flujos de ingresos

Licencias potenciales de tecnologías de inmunoterapia

A partir del cuarto trimestre de 2023, el Enlivex Therapeutics tiene posibles flujos de ingresos de la licencia de su plataforma de inmunomodulación patentada. El activo principal de la compañía, Allocetra ™, representa una oportunidad de licencia potencial con un valor potencial estimado que oscila entre $ 50 millones y $ 150 millones en posibles pagos por adelantado y hitos.

Comercialización de productos terapéuticos futuros

Producto	Mercado potencial	Potencial de ingresos estimado
Allocetra ™ para GVHD	Mercado de trasplante de células madre	$ 75-100 millones anualmente
Allocetra ™ para sepsis	Mercado de cuidados críticos	$ 120-180 millones anualmente

Subvenciones y asociaciones de investigación

En 2023, Enlivex obtuvo aproximadamente $ 2.3 millones en subvenciones de investigación de varias fundaciones científicas y programas de investigación gubernamentales.

Pagos potenciales de hitos de colaboraciones

• Pagos potenciales de hitos del desarrollo clínico: $ 5-10 millones
• Pagos de hitos de aprobación regulatoria potencial: $ 15-25 millones
• Pagos de hitos de comercialización potencial: $ 30-50 millones

Financiamiento de capital e inversiones en el mercado público

A diciembre de 2023, elivex ha aumentado aproximadamente $ 78.5 millones a través de ofertas del mercado público y ubicaciones privadas. La capitalización de mercado de la compañía fue aproximadamente $ 124 millones a partir de enero 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.