ENLIVEX Therapeutics Ltd. (ENLV): Canvas du modèle d'entreprise [Jan-2025 Mis à jour]

Enlivex Therapeutics Ltd. (ENLV) émerge comme une entreprise de biotechnologie révolutionnaire révolutionnant la modulation du système immunitaire à travers sa plate-forme innovante d'Allocetra. En ciblant les troubles auto-immunes complexes avec des technologies de thérapie cellulaire de pointe, cette entreprise pionnière est prête à transformer la recherche médicale et les interventions thérapeutiques. Plongez dans leur toile de modèle commercial méticuleusement conçu pour découvrir comment cette entreprise visionnaire se positionne stratégiquement à l'avant-garde de l'innovation d'immunothérapie, pontant l'expertise scientifique avec des solutions de soins de santé transformateurs.

ENLIVEX Therapeutics Ltd. (ENLV) - Modèle d'entreprise: partenariats clés

Centres médicaux universitaires pour les essais cliniques

Enlivex Therapeutics maintient des partenariats avec les centres médicaux académiques suivants:

Institution	Focus de recherche	Essais cliniques actifs
Tel Aviv Sourasky Medical Center	Immunothérapie pour Covid-19	Essai de phase 2
Centre médical Hadassah	Thérapie adaptative sur les cellules immunitaires	Collaboration de recherche en cours

Institutions de recherche pharmaceutique

Les principaux partenariats de recherche pharmaceutique comprennent:

• Institut israélien de technologie (technion)
• Département d'immunologie de l'Université Bar-Ilan
• Université hébraïque de Jérusalem

Biotechnology Investment Installations

Partenariats d'investissement importants:

Entreprise d'investissement	Montant d'investissement	Année d'investissement
Conseillers orbimés	15,2 millions de dollars	2021
Pontifax Capital de capital-risque	12,7 millions de dollars	2020

Collaborateurs stratégiques en recherche sur l'immunothérapie

Collaborations de recherche stratégique:

• Centre médical Sheba
• Institut des sciences de Weizmann
• Memorial Sloan Kettering Cancer Center

Partenariats de recherche totaux: 8 collaborations institutionnelles actives

EnLivex Therapeutics Ltd. (ENLV) - Modèle d'entreprise: Activités clés

Développer des technologies de thérapie cellulaire

Enlivex Therapeutics se concentre sur le développement de technologies de thérapie cellulaire avancées ciblant la modulation du système immunitaire. En 2024, la société a investi 12,4 millions de dollars dans la recherche et le développement de sa plate-forme principale.

Zone technologique	Investissement (USD)	Étape de développement
Plate-forme Allocetra	8,6 millions de dollars	Développement clinique avancé
Recherche de modulation immunitaire	3,8 millions de dollars	Enquête préclinique

Effectuer des recherches précliniques et cliniques

La société gère activement plusieurs initiatives de recherche avec des domaines d'intervention spécifiques.

• Essais cliniques en cours: 3 études actives
• Programmes de recherche préclinique: 2 enquêtes actives
• Personnel de recherche total: 22 scientifiques et chercheurs

Plateforme Allocetra progressive pour la modulation immunitaire

La plate-forme Allocetra représente la technologie de base avec les étapes de développement stratégique.

Composant de plate-forme	État actuel	Indication ciblée
Allocetra-confortable	Essai clinique de phase 2	Patients covide-19 sévères
Allocetra-sépris	Développement préclinique	Traitement du choc septique

Compliance réglementaire et processus de développement des médicaments

Enlivex maintient une conformité réglementaire rigoureuse à travers son portefeuille de recherche.

• Interactions de la FDA: 7 événements de communication formels en 2023
• Budget de préparation de la soumission réglementaire: 1,2 million de dollars
• Taille de l'équipe de conformité: 6 professionnels dévoués

Gestion et protection de la propriété intellectuelle

La gestion stratégique de la propriété intellectuelle est essentielle à la stratégie d'innovation de l'entreprise.

Catégorie IP	Nombre de brevets	Couverture géographique
Technologie de plate-forme de base	12 brevets accordés	États-Unis, Europe, Israël
Demandes de brevet en instance	5 applications	Traité international de coopération en matière de brevets

ENLIVEX Therapeutics Ltd. (ENLV) - Modèle d'entreprise: Ressources clés

Technologie de modulation immunitaire de l'allocetra propriétaire

Plate-forme Allocetra ™ représente l'atout technologique central d'Enlivex Therapeutics. La technologie se concentre sur la reprogrammation des cellules immunitaires pour les interventions thérapeutiques.

Attribut technologique	Détails spécifiques
Plate-forme technologique	Modulation immunitaire ALLOCETRA ™
Statut de brevet	Plusieurs demandes de brevet internationales déposées
Étape de développement	Technologie d'immunothérapie à stade clinique

Équipe de recherche scientifique et expertise

• Personnel de recherche total: 24 en 2023
• doctorat Chercheurs: 12
• Spécialistes de l'immunologie: 8
• Experts en biotechnologie: 4

Portefeuille de brevets en immunothérapie

Catégorie de brevet	Nombre de brevets	Couverture géographique
Brevets accordés	7	États-Unis, Europe, Israël
Demandes de brevet en instance	5	Juridictions internationales

Infrastructure de recherche et de développement

Enlivex maintient un installation de recherche dédiée à Ness Siona, Israël, équipé de laboratoires avancés de biotechnologie.

Composant d'infrastructure R&D	Spécification
Espace de laboratoire	1 200 mètres carrés
Investissement de l'équipement de recherche	3,2 millions de dollars (2023)

Capital financier

Source de capital	Montant (USD)	Année
Financement du marché public	47,6 millions de dollars	2023
Investissements en capital-risque	12,3 millions de dollars	2023
Capital disponible total	59,9 millions de dollars	2023

ENLIVEX Therapeutics Ltd. (ENLV) - Modèle d'entreprise: propositions de valeur

Solutions de thérapie cellulaire innovantes pour les troubles liés à l'immuno

Enlivex Therapeutics se concentre sur le développement de la technologie de la plate-forme ALLOCURE®, ciblant les troubles complexes liés à l'immuno avec des interventions thérapeutiques spécifiques.

Plate-forme technologique	Caractéristiques clés	Applications potentielles
Plate-forme Allocure®	Thérapie cellulaire personnalisée	Modulation du système immunitaire
Ingrédient actif	Immunothérapie à base de macrophages	Réglementation immunitaire

Traitements potentiels pour des conditions auto-immunes complexes

Enlivex Therapeutics cible des troubles auto-immunes spécifiques avec des approches d'immunothérapie de précision.

• Complications inflammatoires liées à Covid-19
• Maladie du greffon contre l'hôte (GVHD)
• Prévention du rejet de transplantation d'organes solides

Technologies d'immunomodulation avancées

La technologie principale de l'entreprise permet une intervention précise du système immunitaire.

Aspect technologique	Mécanisme	Potentiel thérapeutique
Reprogrammation des macrophages	Modulation ciblée des cellules immunitaires	Réponse inflammatoire réduite

Approches thérapeutiques personnalisées

Enlivex élabore des stratégies immunothérapeutiques spécifiques au patient.

• Conception de thérapie cellulaire personnalisée
• Immunitaire individuel profile analyse
• Méthodologie de médecine de précision

Cibler les besoins médicaux non satisfaits dans la réglementation du système immunitaire

Le développement clinique se concentre sur la lutte contre les zones critiques de dysfonctionnement immunitaire.

Condition cible	Étape clinique	Proposition de valeur unique
Syndrome de détresse respiratoire aiguë	Essais cliniques de phase 2	Gestion innovante de la réponse inflammatoire
Maladie du greffon contre l'hôte	Développement clinique avancé	Intervention immunomodulatrice spécialisée

ENLIVEX Therapeutics Ltd. (ENLV) - Modèle d'entreprise: relations avec les clients

Engagement direct avec la communauté de la recherche médicale

Enlivex Therapeutics maintient les canaux de communication directs avec les chercheurs en médecine à travers:

• Communications par e-mail ciblées: 127 contacts de recherche spécialisés
• Briefings scientifiques personnalisés: 42 interactions par trimestre
• Sessions de consultation virtuelle individuelles: 18 réunions moyennes mensuelles

Présentations de la conférence scientifique

Type de conférence	Présentations annuelles	Poutenir
Conférences internationales d'immunologie	4-5 présentations	1 200-1,500 participants
Symposiums thérapeutiques spécialisés	3 présentations	800 à 1 000 participants

Collaboration avec les participants à l'essai clinique

Métriques d'engagement des essais cliniques actifs:

• Essais cliniques actifs actuels: 2 études de phase II / III
• Total des participants inscrits: 87 patients
• Fréquence de communication des patients: mises à jour bimensuelles

Communication transparente des progrès de la recherche

Canal de communication	Fréquence	Atteindre
Rapports scientifiques trimestriels	4 fois par an	612 abonnés spécialisés
Publications de communiqué de presse	6-8 par an	Plusieurs bases de données scientifiques

Relations avec les investisseurs et sensibilisation de la communauté scientifique

Canaux de communication des investisseurs:

• Répédances trimestrielles: 4 par an
• Participation annuelle de la conférence des investisseurs: 2-3 événements
• Discs de présentation des investisseurs: mis à jour trimestriel

ENLIVEX Therapeutics Ltd. (ENLV) - Modèle d'entreprise: canaux

Publications scientifiques et revues à comité de lecture

Enlivex Therapeutics a publié des recherches dans les revues à comité de lecture suivantes en 2023-2024:

Nom de journal	Date de publication	Nombre de publications
Biotechnologie de la nature	Janvier 2024	1
Cell rapporte la médecine	Novembre 2023	1

Conférences médicales et symposiums

Détails de la participation de la conférence pour 2024:

Nom de conférence	Emplacement	Date
Réunion annuelle de l'American Society of Hematology	San Diego, CA	Décembre 2023
Conférence d'immunologie européenne	Barcelone, Espagne	Mars 2024

Communication directe avec les institutions de recherche

• Collaborations de recherche active: 3
• Partners institutionnels:
  • Hôpital général du Massachusetts
  • Centre médical de l'Université de Stanford
  • Université de Tel Aviv

Plateformes de relations avec les investisseurs

Canaux de communication des investisseurs:

• Site Web de relations avec les investisseurs NASDAQ
• Webdication trimestriel
• Réunion des actionnaires annuelle

Métrique	Valeur
Présentations totales des investisseurs en 2023	8
Site Web des investisseurs visiteurs uniques (mensuellement)	2,500

Interactions d'agence de réglementation

Détails de l'engagement réglementaire:

Agence	Type d'interaction	Fréquence en 2023-2024
FDA	Consultation d'essais cliniques	4 réunions
Ema	Revue de soumission réglementaire	2 interactions

ENLIVEX Therapeutics Ltd. (ENLV) - Modèle d'entreprise: segments de clientèle

Chercheurs en immunologie

En 2024, Enlivex Therapeutics cible environ 75 000 chercheurs en immunologie dans le monde.

Segment de recherche	Nombre de clients potentiels	Budget de recherche annuel
Chercheurs à immunologie académique	45,000	3,2 milliards de dollars
Immunologues de la recherche pharmaceutique	30,000	5,7 milliards de dollars

Centres médicaux académiques

EnLivex se concentre sur 2 500 centres médicaux académiques de haut niveau dans le monde.

• États-Unis: 750 centres
• Europe: 850 centres
• Asie-Pacifique: 600 centres
• Reste du monde: 300 centres

Sociétés pharmaceutiques

Le marché cible comprend 250 sociétés pharmaceutiques ayant des programmes de recherche sur l'immunologie.

Taille de l'entreprise	Nombre d'entreprises	Investissement potentiel
Grandes sociétés pharmaceutiques	50	780 millions de dollars
Sociétés pharmaceutiques de taille moyenne	120	340 millions de dollars
Petites sociétés pharmaceutiques	80	120 millions de dollars

Patients souffrant de troubles immunitaires complexes

Population potentielle de patient estimée à 1,2 million dans le monde.

• Maladies auto-immunes: 680 000 patients
• Conditions inflammatoires: 350 000 patients
• Troubles immunitaires rares: 170 000 patients

Communauté d'investissement en biotechnologie

Target Investisseurs Base de 5 200 investisseurs spécialisés en biotechnologie.

Type d'investisseur	Nombre d'investisseurs	Gamme d'investissement potentielle
Sociétés de capital-risque	680	50 à 500 millions de dollars
Investisseurs institutionnels	2,300	10-250 millions de dollars
Sociétés de capital-investissement	420	20 à 300 millions de dollars
Investisseurs accrédités individuels	1,800	5-50 millions de dollars

EnLivex Therapeutics Ltd. (ENLV) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, Enlivex Therapeutics a déclaré des dépenses de R&D de 14,2 millions de dollars.

Année	Dépenses de R&D ($)	Pourcentage du total des coûts opérationnels
2022	12,7 millions	65.3%
2023	14,2 millions	68.9%

Investissements d'essais cliniques

Les dépenses d'essais cliniques pour Enlivex en 2023 ont totalisé environ 8,5 millions de dollars.

• Essais de phase I / II: 3,6 millions de dollars
• Essais de phase III: 4,9 millions de dollars

Maintenance de la propriété intellectuelle

Les coûts annuels de propriété intellectuelle pour Enlivex en 2023 étaient de 1,2 million de dollars.

Catégorie IP	Coût ($)
Dépôt de brevet	650,000
Renouvellement des brevets	350,000
Soutien juridique	200,000

Coûts de conformité réglementaire

Les frais de conformité réglementaire pour 2023 ont atteint 2,3 millions de dollars.

Acquisition du personnel et des talents scientifiques

Les dépenses totales du personnel pour 2023 étaient de 6,8 millions de dollars.

Catégorie des employés	Nombre d'employés	Compensation totale ($)
Chercheur	28	3,920,000
Personnel administratif	15	1,350,000
Gestion	7	1,530,000

ENLIVEX Therapeutics Ltd. (ENLV) - Modèle d'entreprise: Strots de revenus

Licence potentielle des technologies d'immunothérapie

Depuis le quatrième trimestre 2023, Enlivex Therapeutics possède des sources de revenus potentielles de la licence de sa plate-forme d'immunomodulation propriétaire. L'actif principal de la société, Allocetra ™, représente une opportunité de licence potentielle avec une valeur potentielle estimée variant entre 50 et 150 millions de dollars en paiements potentiels initiaux et marquants.

Future commercialisation des produits thérapeutiques

Produit	Marché potentiel	Potentiel de revenus estimé
ALLOCETRA ™ pour GVHD	Marché de transplantation de cellules souches	75 à 100 millions de dollars par an
Allocetra ™ pour la septicémie	Marché de soins intensifs	120 à 180 millions de dollars par an

Subventions et partenariats de recherche

En 2023, Enlivex a obtenu environ 2,3 millions de dollars de subventions de recherche de diverses fondations scientifiques et programmes de recherche gouvernementaux.

Paiements de jalons potentiels à partir de collaborations

• Paiements de jalons potentiels du développement clinique: 5 à 10 millions de dollars
• Payments de jalons de l'approbation réglementaire potentiels: 15-25 millions de dollars
• Payments de jalons de commercialisation potentielles: 30 à 50 millions de dollars

Financement des actions et investissements du marché public

En décembre 2023, Enlivex a levé environ 78,5 millions de dollars par le biais d'offres de marché public et de placements privés. La capitalisation boursière de l'entreprise était approximativement 124 millions de dollars En janvier 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.