Brainstorm Cell Therapeutics Inc. (BCLI): Business Model Canvas [Jan-2025 Mis à jour]

Brainstorm Cell Therapeutics Inc. (BCLI) se situe à la pointe de la médecine régénérative, des thérapies cellulaires révolutionnaires pionnières qui offrent de l'espoir aux patients luttant contre les troubles neurologiques dévastateurs. En tirant parti de leur technologie révolutionnaire de cellules souches mésenchymateuses de Nurown, la société transforme le paysage du traitement pour des conditions comme la SLA et la Parkinson, où les approches médicales traditionnelles ont échoué. Leur modèle commercial innovant représente une fusion audacieuse de l'innovation scientifique, des partenariats stratégiques et un engagement profond à répondre aux besoins médicaux non satisfaits, en positionnant le BCLI en tant que changeur de jeu potentiel dans le monde complexe de la thérapeutique cellulaire.

Brainstorm Cell Therapeutics Inc. (BCLI) - Modèle commercial: partenariats clés

Collaboration avec les établissements de recherche universitaires

Brainstorm Cell Therapeutics a établi des partenariats de recherche avec les établissements universitaires suivants:

Institution	Focus de la collaboration	Année établie
Hôpital général du Massachusetts	Recherche de maladies neurologiques	2017
École de médecine de Harvard	Développement thérapeutique des cellules souches	2019

Partenariats stratégiques avec les centres de traitement des maladies neurologiques

La société a développé des partenariats stratégiques avec des centres de traitement spécialisés:

• Département de neurologie de la santé NYU Langone
• Institut neurologique de la Cleveland Clinic
• Centre de neurologie de l'hôpital Johns Hopkins

Financement et soutien à la recherche des subventions gouvernementales

Brainstorm Cell Therapeutics a obtenu le financement de la recherche gouvernementale:

Agence de financement	Montant d'octroi	Objectif de recherche
National Institutes of Health (NIH)	2,3 millions de dollars	Recherche de thérapie des cellules souches ALS
Ministère de la Défense	1,7 million de dollars	Développement du traitement des maladies neurologiques

Alliances potentielles de développement pharmaceutique

Les partenariats potentiels actuels de développement pharmaceutique comprennent:

• Novartis AG - Discussions préliminaires pour la collaboration thérapeutique neurologique
• Biogen Inc. - Partenariat exploratoire pour l'intégration de la technologie des cellules souches
• AbbVie Inc. - Alliance de recherche potentielle pour les traitements de maladies neurodégénératives

Brainstorm Cell Therapeutics Inc. (BCLI) - Modèle d'entreprise: activités clés

Développer des thérapies cellulaires régénératives pour les troubles neurologiques

Brainstorm Cell Therapeutics se concentre sur le développement de la technologie Nurown®, une plate-forme de thérapie cellulaire autologue propriétaire. La société a investi environ 120 millions de dollars dans la recherche et le développement en 2023.

Domaine de recherche	Investissement	Étape actuelle
Technologie Nurown®	120 millions de dollars	Essais cliniques avancés
Traitement ALS	45 millions de dollars	Essais cliniques de phase 3
La recherche de Parkinson	35 millions de dollars	Développement préclinique

Effectuer des essais cliniques pour la technologie Nurown

L'entreprise a effectué plusieurs essais cliniques dans différentes conditions neurologiques.

• Terminé 3 essais cliniques terminés pour la SLA
• Effectué 2 essais de phase 2 pour la maladie de Parkinson
• Essais cliniques en cours dans plusieurs troubles neurologiques

Recherche sur le traitement des cellules souches pour les conditions neurologiques

Condition	Focus de recherche	Progrès actuel
ALS	Thérapie par cellules souches mésenchymateuses	Étape clinique avancée
Maladie de Parkinson	Régénération neuronale	Recherche préclinique
Sclérose en plaques	Immunomodulation	Enquête en un stade précoce

Poursuivre les approbations réglementaires pour les thérapies cellulaires innovantes

Brainstorm s'est engagé avec la FDA et l'EMA pour les approbations potentielles de thérapie.

• Application de licence de biologie soumise (BLA) pour Nurown® dans la SLA
• Interactions réglementaires en cours pour le traitement de la maladie de Parkinson
• Accumulé plus de 250 points de données des patients dans les essais cliniques

Brainstorm Cell Therapeutics Inc. (BCLI) - Modèle commercial: Ressources clés

Technologie propriétaire des cellules souches mésenchymateuses de Nurown

La plate-forme technologique de Nurown implique des cellules stromales mésenchymateuses autologues (CSM) qui sont conçues pour sécréter des facteurs neurotrophiques.

Caractéristique technologique	Détails spécifiques
Statut de brevet	Multiples brevets délivrés aux États-Unis et juridictions internationales
Étape de développement	Développement clinique avancé pour les maladies neurodégénératives
Mécanisme unique	Approche de thérapie cellulaire ciblée

Équipe de recherche et développement spécialisée

L'équipe de R&D de Brainstorm comprend des professionnels scientifiques spécialisés axés sur les traitements des maladies neurologiques.

• Personnel total de R&D: environ 25-30 chercheurs
• Rechercheurs de doctorat: environ 15
• Expérience de recherche cumulative: plus de 150 ans combinés

Portefeuille de propriété intellectuelle

Catégorie IP	Nombre d'actifs
Brevets délivrés	12
Demandes de brevet	8
Couverture géographique	États-Unis, Europe, Israël

Installations avancées de laboratoire et de recherche

Brainstorm maintient une infrastructure de fabrication et de recherche cellulaire spécialisée.

• Lieu de recherche primaire: Hackensack, New Jersey
• Installation de fabrication de cellules: conforme au CGMP
• Investissement de l'équipement de recherche: environ 3,2 millions de dollars

Données des essais cliniques et expertise scientifique

Métrique d'essai clinique	Données quantitatives
Essais cliniques terminés	5
Essais cliniques en cours	3
Inscription totale	Environ 250 patients

Brainstorm Cell Therapeutics Inc. (BCLI) - Modèle d'entreprise: propositions de valeur

Solutions innovantes de thérapie cellulaire régénérative

Brainstorm Cell Therapeutics se concentre sur le développement Technologie Nurown®, une plate-forme de thérapie cellulaire propriétaire ciblant les troubles neurologiques.

Plate-forme technologique	Caractéristiques clés
Technologie Nurown®	Traitement des cellules souches mésenchymateuses personnalisées
Processus de modification des cellules	Induit des cellules à sécréter des facteurs neurotrophiques

Traitements de percés potentiels pour les troubles neurologiques

Les domaines primaires thérapeutiques thérapeutiques comprennent:

• Sclérose latérale amyotrophique (SLA)
• Maladie de Parkinson
• Sclérose en plaques

Approches thérapeutiques personnalisées

Caractéristique du traitement	Détails spécifiques
Cellules spécifiques au patient	Dérivé de la moelle osseuse du patient
Niveau de personnalisation	Thérapie cellulaire hautement personnalisée

Espoir pour les patients avec des options de traitement limitées

Les données des essais cliniques démontrent des avantages thérapeutiques potentiels pour les patients présentant des traitements alternatifs limités.

Technologie cellulaire avancée ciblant les besoins médicaux non satisfaits

Aspect technologique	Besoin médical non satisfait
Sécrétion de facteurs neurotrophiques	Atténuation de la progression de la maladie neurologique
Potentiel régénératif	Protection neuronale et réparation potentielle

Brainstorm Cell Therapeutics Inc. (BCLI) - Modèle d'entreprise: relations clients

Engagement direct avec les communautés de patients

Les thérapies cellulaires du cerveau maintiennent des stratégies d'engagement directes des patients pour la recherche sur les maladies neurologiques, se concentrant spécifiquement sur les populations de patients SLA (sclérose latérale amyotrophique).

Métriques d'engagement communautaire des patients	2024 données
Réseau total de soutien aux patients	475 patients enregistrés
Sessions annuelles d'information sur les patients	12 événements virtuels et en personne
Canaux de rétroaction du patient	3 plateformes de communication dédiées

Communication transparente sur les progrès des essais cliniques

La société maintient des protocoles de communication rigoureux pour la transparence des essais cliniques.

• Fréquence de mise à jour des essais cliniques de Nurown®: rapports trimestriels
• Résultats des essais cliniques publiés: 2 publications complètes en 2023
• Canaux de communication des patients: site Web, newsletters par e-mail, présentations de conférences médicales

Sensibilisation et éducation professionnelle médicale

Brainstorm Cell Therapeutics met en œuvre des stratégies d'engagement professionnel médical ciblées.

Métriques de sensibilisation professionnelles	2024 données
Engagement du réseau de neurologues	287 spécialistes neurologiques actifs
Présentations annuelles de la conférence médicale	5 conférences internationales
Programmes de formation médicale continue (CME)	3 ateliers spécialisés

Programmes de soutien aux patients et d'information

Infrastructure complète de soutien aux patients conçu pour fournir des informations et des ressources complètes.

• Héponse de soutien aux patients dévoués: Disponible 5 jours / semaine
• Portail de ressources en ligne: accès d'informations multilingues
• Inscription du programme d'assistance aux patients: 215 participants actifs

Approche de recherche collaborative avec les institutions médicales

Les collaborations stratégiques avec les principaux établissements de recherche médicale améliorent la gestion de la relation client.

Détails de collaboration de recherche	2024 données
Partenariats de recherche actifs	7 institutions médicales internationales
Financement conjoint de la recherche	3,2 millions de dollars alloués
Publication collaborative Sormes	4 articles de recherche évalués par des pairs

Brainstorm Cell Therapeutics Inc. (BCLI) - Modèle d'entreprise: canaux

Conférences médicales directes et présentations

Brainstorm Cell Therapeutics utilise des conférences scientifiques pour la communication des canaux. En 2023, l'entreprise a participé à:

Conférence	Date	Emplacement
American Academy of Neurology Annual	Avril 2023	Boston, MA
Conférence internationale sur les cellules souches	Septembre 2023	San Francisco, CA

Publications scientifiques et revues de recherche

Les canaux de publication comprennent:

• Annales de neurologie
• Rapports de cellules souches
• Journal of Neurological Sciences

Communications des relations avec les investisseurs

Canaux de communication des investisseurs:

Canal	Fréquence
Appels de résultats trimestriels	4 fois par an
Réunion des actionnaires annuelle	1 fois par an
Présentations des investisseurs	6-8 fois par an

Plateformes de recrutement d'essais cliniques

Les canaux de recrutement comprennent:

• ClinicalTrials.gov
• Essais de recherche clinique du NIH
• Registres des patients en neurologie

Partenariats avec les centres de traitement de neurologie

Institution partenaire	Focus de la collaboration
Hôpital général du Massachusetts	RECHERCHE ALS
Stanford Neuroscience Institute	Développement de la thérapie des cellules souches
NYU Langone Health	Coordination des essais cliniques

Brainstorm Cell Therapeutics Inc. (BCLI) - Modèle d'entreprise: segments de clientèle

Patients atteints de SLA et d'autres troubles neurologiques

Les thérapies cellulaires du brainstorm ciblent environ 16 000 patients atteints de SLA aux États-Unis. Population de patients mondiaux de la SLA estimée à 450 000 personnes dans le monde.

Segment des patients	Taille de la population	Incidence annuelle
Patients ALS (États-Unis)	16,000	5 000 nouveaux cas / an
Patients mondiaux de la SLA	450,000	140 000 nouveaux cas / an

Neurologues et médecins spécialistes

Le marché cible comprend environ 6 500 neurologues aux États-Unis spécialisés dans les troubles neurodégénératifs.

• Les neurologues traitant la SLA: 1 200 spécialistes estimés
• Des centres médicaux universitaires axés sur la recherche neurodégénérative: 120 institutions

Institutions de recherche

Brainstorm Cell Therapeutics collabore avec plusieurs centres de recherche se concentrant sur les troubles neurologiques.

Type d'institution de recherche	Nombre de collaborateurs potentiels
Centres de recherche universitaires	85
Instituts de recherche en neurosciences	42

Fournisseurs de soins de santé

Les prestataires de soins de santé cibles comprennent des cliniques de neurologie spécialisées et des centres de traitement de la SLA.

• Centres de traitement spécialisés de la SLA aux États-Unis: 48
• Cliniques de neurologie capables de thérapie cellulaire avancée: 320

Groupes de défense des patients

Collaboration avec les organisations nationales et internationales de défense de la SLA.

Type de groupe de plaidoyer	Nombre d'organisations
Organisations nationales de la SLA	12
Groupes de plaidoyer internationaux de la SLA	25

Brainstorm Cell Therapeutics Inc. (BCLI) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, Brainstorm Cell Therapeutics a signalé des dépenses de R&D totalisant 16,4 millions de dollars.

Catégorie de dépenses	Montant ($)
Développement de la technologie Nurown®	8,200,000
Recherche préclinique	3,600,000
Préparation des essais cliniques	4,600,000

Coûts de gestion des essais cliniques

Les dépenses des essais cliniques pour 2023 étaient d'environ 12,7 millions de dollars, axées sur les indications des maladies neurologiques.

• Essais cliniques de la SLA: 6 500 000 $
• Essais de sclérose en plaques: 4 200 000 $
• Coûts d'étude favorables: 2 000 000 $

Protection de la propriété intellectuelle

Les dépenses annuelles de protection de la propriété intellectuelle ont été de 1,2 million de dollars en 2023.

Type de protection IP	Coût ($)
Dépôt de brevet	650,000
Consultation juridique	350,000
Frais d'entretien	200,000

Investissements de conformité réglementaire

Les coûts de conformité réglementaire pour 2023 ont totalisé 2,5 millions de dollars.

• Préparation de la soumission de la FDA: 1 200 000 $
• Conseil réglementaire: 800 000 $
• Documentation de la conformité: 500 000 $

Personnel et talent scientifique spécialisé

Les dépenses de personnel pour les talents scientifiques spécialisés se sont élevés à 9,3 millions de dollars en 2023.

Catégorie de personnel	Coût annuel ($)
Chercheur	4,500,000
Chercheurs en clinique	2,800,000
Soutien administratif	2,000,000

Brainstorm Cell Therapeutics Inc. (BCLI) - Modèle commercial: Strots de revenus

Ventes potentielles de produits thérapeutiques potentiels

En 2024, Brainstorm Cell Therapeutics se concentre sur les revenus potentiels de la technologie Nurown® pour les troubles neurologiques, ciblant spécifiquement la SLA et d'autres conditions neurodégénératives.

Produit	Marché potentiel	Potentiel de revenus estimé
Nurown® pour la SLA	Traitement des troubles neurologiques	12 à 15 millions de dollars potentiel annuel prévu

Subventions de recherche et financement gouvernemental

Brainstorm Cell Therapeutics assure le financement par diverses subventions de recherche et mécanismes de soutien du gouvernement.

Source de financement	Montant (2023-2024)	But
National Institutes of Health (NIH)	2,3 millions de dollars	Soutien à la recherche neurologique

Licence potentielle des technologies propriétaires

La propriété intellectuelle de la société représente une source de revenus potentiel importante.

• Potentiel de licence de technologie cellulaire Nurown®
• Traitement des troubles neurologiques Portfolio des brevets
• Réduction des revenus des licences estimées: 5 à 8 millions de dollars par an

Accords de partenariat stratégique

Les accords de collaboration offrent des opportunités de revenus supplémentaires.

Partenaire	Type d'accord	Impact financier potentiel
Tier-1 Pharmaceutical Company	Collaboration de recherche	3,5 millions de dollars de paiement jalon

Financement des investisseurs et augmentation du capital

Les activités de levée de capitaux contribuent aux ressources financières de l'entreprise.

Ronde de financement	Montant recueilli	Date
Placement privé	6,2 millions de dollars	Q4 2023

Total des sources de revenus potentiels: environ 20 à 25 millions de dollars par an

Brainstorm Cell Therapeutics Inc. (BCLI) - Canvas Business Model: Value Propositions

The core value proposition for Brainstorm Cell Therapeutics Inc. centers on delivering a potentially disease-modifying therapy for devastating neurodegenerative conditions, leveraging proprietary cell and exosome technology.

Disease-modifying therapy for ALS: NurOwn aims to slow progression and improve quality of life.

The clinical evidence supporting NurOwn (MSC-NTF cells) for Amyotrophic Lateral Sclerosis (ALS) is anchored in long-term survival data from patients treated under expanded access. You should note the stark contrast in survival rates observed in this patient group.

Metric	NurOwn EAP Cohort (n=10)	Published ALS Estimates
Survival > 5 Years from Symptom Onset	90% (9/10 participants)	Approximately 10%
Median Survival from Symptom Onset	6.8 years (Range: 6 to 7 years)	Not directly comparable, but significantly lower
Survival > 7 Years from Symptom Onset	60% (6/10 participants)	Extremely low probability

The company is advancing the Phase 3b ENDURANCE study, which is designed to generate the necessary confirmatory data to support a potential Biologics License Application (BLA) submission. This trial is being conducted under an agreement with the U.S. Food and Drug Administration (FDA) via a Special Protocol Assessment (SPA). The primary efficacy measure for the initial randomized, double-blind, placebo-controlled period (Part A) is the change from baseline to Week 24 on the ALS Functional Rating Scale-Revised (ALSFRS-R). This upcoming pivotal trial is expected to enroll approximately 200 participants at leading ALS centers.

Autologous cell therapy: Personalized treatment using the patient's own cells.

Brainstorm Cell Therapeutics Inc. focuses on an autologous approach, meaning the treatment is derived from the patient's own cells. This personalization is inherent to the platform's design.

• The proprietary NurOwn platform uses autologous mesenchymal stem cells (MSCs).
• These MSCs are engineered to produce neurotrophic factor-secreting cells, referred to as MSC-NTF cells.
• NurOwn has secured Orphan Drug designation from both the U.S. FDA and the European Medicines Agency (EMA) for ALS.

Potential for other neurodegenerative diseases: Platform applicability to Progressive MS and Parkinson's.

The underlying technology shows application beyond ALS, though the focus remains on the lead candidate. The platform has been tested in other indications.

• Completed a Phase 2 open-label multicenter trial (NCT03799718) in progressive multiple sclerosis (MS).
• This MS trial was supported by a grant from the National MS Society.

Exosome platform: Scalable, allogeneic delivery system for therapeutic proteins.

A significant secondary value driver is the proprietary exosome technology, which offers a potential shift toward a more scalable, off-the-shelf product. The company has been building its intellectual property fortress here.

Exosome Platform Attribute	Data Point/Status
Platform Type	Proprietary, allogeneic
Delivery Capability	Designed to deliver therapeutic proteins and nucleic acids
Intellectual Property Status	Received Notice of Allowance from U.S. Patent and Trademark Office
Patent Protection Expiration (Estimated)	Until April 10, 2039
Exosome Size	Typically 30-120 nm

The company is actively pursuing strategic collaborations for this exosome platform. Financially, as of the third quarter ended September 30, 2025, Brainstorm Cell Therapeutics Inc. reported cash, cash equivalents, and restricted cash of approximately $0.23 million. For that same quarter, Research and development expenditures, net, were $0.9 million, and General and administrative expenses were approximately $1.1 million, resulting in a net loss of approximately $2.1 million.

Brainstorm Cell Therapeutics Inc. (BCLI) - Canvas Business Model: Customer Relationships

You're looking at how Brainstorm Cell Therapeutics Inc. (BCLI) manages its critical relationships, which are heavily skewed toward the patient and scientific communities given its clinical stage in developing NurOwn for ALS. This is not a typical B2C or B2B model; it's a highly specialized, high-stakes relationship structure.

High-touch engagement with the ALS patient community and advocates

Brainstorm Cell Therapeutics Inc. maintains a close relationship with the ALS community, which is vital for trial recruitment and public support. The company explicitly stated its commitment to working with the ALS community. This engagement is underscored by the acknowledgment of a Citizen Petition filed with the U.S. Food and Drug Administration (FDA) by representatives of the ALS community, requesting a renewed regulatory review of the data supporting NurOwn. The company views this petition as a constructive development that highlights the ongoing interest in NurOwn's potential therapeutic value. The prior Expanded Access Program (EAP) data showed that 10/10 participants in that program survived more than 5 years from the onset of ALS symptoms, a stark contrast to published estimates of approximately 10% survival beyond 5 years for the general ALS population.

• Citizen Petition filed by ALS community representatives with the FDA.
• Commitment to working with the ALS community if NurOwn is approved.
• 100% survival past 5 years for 10 EAP participants.

Direct support and communication with clinical trial participants

The success of the upcoming Phase 3b ENDURANCE study hinges on strong relationships with the participants who will receive the therapy. The company is advancing pre-initiation activities for this trial, which is expected to enroll approximately 200 participants at leading ALS centers. This trial structure includes a 24-week, randomized, double-blind, placebo-controlled period (Part A), followed by a 24-week open-label extension (Part B) where all participants will receive NurOwn. This structure suggests a commitment to providing the therapy to all enrolled patients eventually, which is a key component of participant retention and trust.

Trial Phase	Expected Enrollment	Treatment Duration (Part A)	Extension Treatment (Part B)
Phase 3b ENDURANCE	Approximately 200 participants	24 weeks (double-blind, placebo-controlled)	24 weeks (open-label, all receive NurOwn)

Scientific engagement with Key Opinion Leaders (KOLs) and clinical investigators

Engagement with the scientific community, including KOLs and clinical investigators, is managed through rigorous data presentation and collaboration on trial design. Brainstorm Cell Therapeutics Inc. secured U.S. FDA clearance for the planned clinical study and is advancing activities with its network of clinical sites. The company's scientific findings were presented orally at the International Society for Cell & Gene Therapy (ISCT) 2025 Annual Meeting in May 2025, focusing on pharmacogenomic data related to the UNC13A genotype and its impact on clinical outcomes for ALS patients treated with NurOwn. This demonstrates active participation in the scientific discourse.

Investor relations and public updates on regulatory and financial status

Investor relationships are maintained through regular, though sometimes rescheduled, public updates on regulatory milestones and financial health. As of the third quarter ended September 30, 2025, the company reported cash, cash equivalents, and restricted cash of approximately $0.23 million. The net loss for that quarter was approximately $2.1 million, an improvement from the net loss of approximately $2.7 million in the third quarter of 2024. General and administrative expenses for Q3 2025 were approximately $1.1 million, down from approximately $2.0 million in Q3 2024. The company trades on the OTCQB under the ticker BCLI, with a recent quote showing a price of $0.61 USD. Brainstorm is planning to host a conference call and webcast for the investment community later in Q4 2025 or early Q1 2026 to provide further updates on the NurOwn Phase 3 program.

Here's the quick math on the recent financial stability impacting investor confidence:

Financial Metric (as of Sep 30, 2025)	Amount	Comparison Point
Cash, Cash Equivalents, Restricted Cash	Approximately $0.23 million	N/A
Net Loss (Q3 2025)	Approximately $2.1 million	Down from $2.7 million in Q3 2024
General and Administrative Expenses (Q3 2025)	Approximately $1.1 million	Down from $2.0 million in Q3 2024
Stock Ticker	OTCQB: BCLI	N/A

Finance: draft 13-week cash view by Friday.

Brainstorm Cell Therapeutics Inc. (BCLI) - Canvas Business Model: Channels

You're mapping out how Brainstorm Cell Therapeutics Inc. gets its product, NurOwn, to the patient and how it interfaces with the market and regulators. This isn't about selling widgets off a shelf; it's a highly specialized, clinical-to-regulatory channel strategy.

Specialized Clinical Trial Sites

The primary channel for advancing NurOwn is through the execution of its clinical trials, which rely on a network of specialized centers. The current focus is the Phase 3b ENDURANCE study (ClinicalTrials.gov ID NCT06973629) for Amyotrophic Lateral Sclerosis (ALS).

• The ENDURANCE study is planned to enroll approximately 200 participants.
• This enrollment is taking place across leading academic medical centers.
• The trial has 15 locations in the United States as of May 2025.
• Specific sites include Barrow Neurological Institute in Phoenix, Arizona, and University of California San Diego Medical Center in La Jolla, California.
• The study's estimated start date was June 30, 2025.

This network of sites is the physical channel for drug delivery and data collection, which is critical for the next step in the commercialization path.

Contract Development and Manufacturing Organizations (CDMOs)

Brainstorm Cell Therapeutics Inc. uses external partners for the complex manufacturing of its autologous cell therapy. This outsourcing is a key channel for ensuring clinical supply readiness.

CDMO Partner	Role/Agreement Status	Relevant Trial/Product
Minaris Advanced Therapies	Signed a Letter of Intent (LOI) for manufacturing.	Upcoming Phase 3b clinical trial of NurOwn.
Pluri	Mentioned in an MOU to support the NurOwn trial.	NurOwn trial support.

The company stated in August 2025 that it was engaged in ongoing discussions with these selected CDMO partners to ensure readiness for clinical drug supply. Honestly, managing these complex supply chains is a massive operational channel in itself.

Regulatory Pathway

The most crucial channel for Brainstorm Cell Therapeutics Inc. is the direct, formal interaction with the U.S. Food and Drug Administration (FDA). This channel dictates the entire timeline for potential market access.

• The Phase 3b trial design was established under a Special Protocol Assessment (SPA) agreement with the FDA.
• FDA clearance was secured to initiate the Phase 3b trial.
• Data from Part A of the ENDURANCE study is expected to support a future Biologics License Application (BLA) submission.
• A Citizen Petition was filed with the FDA by ALS community representatives, requesting a renewed regulatory review of existing NurOwn data.

The company reported approximately $0.23 million in cash, cash equivalents, and restricted cash as of September 30, 2025, which underscores the financial reality tied to navigating this regulatory channel successfully.

OTCQB Venture Market

For its common stock, the trading channel is the OTCQB Venture Market, following a delisting from NASDAQ. This is the channel for capital raising and investor liquidity.

Here's the quick math on the stock as of late 2025:

• Stock Symbol: BCLI.
• Trading Price as of Dec 04, 2025: $0.609.
• Day's Range on Dec 04, 2025: $0.600 to $0.630.
• 52-Week Range (as of early Dec 2025): Spans from a low of $0.521 to a high of $2.500.
• Market Capitalization as of Nov 29, 2025: $7.02M (though a figure of $12.91 MM was noted on Nov 24, 2025).

The company reported a net loss for the third quarter ended September 30, 2025, of approximately $2.1 million, which is the financial context for the capital raised through this market channel. Finance: draft 13-week cash view by Friday.

Brainstorm Cell Therapeutics Inc. (BCLI) - Canvas Business Model: Customer Segments

You're looking at the core group Brainstorm Cell Therapeutics Inc. (BCLI) is laser-focused on right now: patients in the very specific window of early-stage Amyotrophic Lateral Sclerosis (ALS) eligible for their pivotal Phase 3b trial, the ENDURANCE study. This isn't a broad market play yet; it's a precise clinical target.

The immediate, most critical customer segment is defined by the trial enrollment target. The upcoming Phase 3b ENDURANCE study is expected to enroll approximately 200 participants at leading ALS centers. These individuals must meet the criteria for early symptomatic ALS and moderate disease presentation. The success of this group directly dictates the next step: supporting a potential Biologics License Application (BLA) submission based on data from the initial 24-week, randomized, double-blind, placebo-controlled period.

To give you a sense of the broader patient pool they are addressing, consider the incidence rate: as of May 2025, the ALS Association noted that a person is diagnosed with this progressive neurodegenerative disease every 90 minutes. That scale underscores the urgency for the entire ALS community, which is a key secondary segment.

The company's operational capacity, which underpins its ability to manage these patient relationships and trials, is reflected in its recent financial standing. Here's the quick math on their late 2025 financial footing:

Financial Metric (As of Late 2025)	Amount/Value	Date Reference
Cash, Cash Equivalents, and Restricted Cash	Approximately $0.23 million	September 30, 2025
Net Loss (Q3 2025)	Approximately $2.1 million	Quarter ended September 30, 2025
Research and Development Expenditures, Net (Q3 2025)	$0.9 million	Quarter ended September 30, 2025
General and Administrative Expenses (Q3 2025)	Approximately $1.1 million	Quarter ended September 30, 2025
Cash and Cash Equivalents (Previous Snapshot)	$1.644 million	March 31, 2025

The next customer group involves the professionals and organizations that facilitate access and provide support to the patients. Brainstorm Cell Therapeutics Inc. is actively working with its network of clinical sites, which are described as leading ALS centers, to ensure operational readiness for the trial. This group is essential for patient recruitment and trial execution.

The engagement with the broader ALS ecosystem is also a defined segment, especially given the recent Citizen Petition filed with the FDA by community representatives requesting a renewed regulatory review of NurOwn's data. This shows a high level of vested interest from the community itself.

• Neurologists and clinicians specializing in neurodegenerative diseases.
• Leading academic medical centers for trial site activation.
• ALS patient advocacy groups and supporting organizations.
• The ALS community, which has actively petitioned for regulatory review.

Looking ahead, the business model anticipates expansion into adjacent, high-need patient populations. This future segment is currently less defined in terms of immediate trial numbers but represents significant long-term opportunity. The company is exploring potential applications of its cell therapy platform in these areas, which means these patients will become active customers if pipeline progression is successful.

• Patients with Progressive MS (PMS).
• Patients with Parkinson's disease.
• Patients with Alzheimer's Disease (AD).

If onboarding takes 14+ days, churn risk rises, even in a trial setting.

Finance: draft 13-week cash view by Friday.

Brainstorm Cell Therapeutics Inc. (BCLI) - Canvas Business Model: Cost Structure

The Cost Structure for Brainstorm Cell Therapeutics Inc. (BCLI) is heavily weighted toward the clinical development and regulatory pathway for its lead candidate, NurOwn. As a pre-revenue biotechnology company, operating expenses are the primary cost drivers, reflecting the intensive nature of late-stage cell therapy development.

The primary operating expenses for the third quarter ended September 30, 2025, are detailed below. You'll note the company achieved expense discipline year-over-year, narrowing its net loss to approximately $2.1 million for the quarter.

Cost Category	Q3 2025 Amount (Approximate)	Comparison to Q3 2024
Research and Development (R&D) Expenses, net	$0.9 million	Decreased from $1.0 million year-over-year
General and Administrative (G&A) Expenses	$1.1 million	Decreased from $2.0 million year-over-year

The R&D spend is directly tied to advancing the NurOwn program. This includes significant, though not explicitly itemized for Q3 2025, costs associated with the Phase 3b ENDURANCE trial.

Clinical Trial Costs are a major component of the R&D expenditure. The ENDURANCE study is a critical, high-cost activity:

• The trial is designed to enroll up to approximately 200 participants at leading ALS centers.
• It follows a two-part structure: a 24-week randomized, double-blind, placebo-controlled period (Part A), followed by a 24-week open-label extension (Part B).
• The trial protocol is being executed under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).

Manufacturing and Technology Transfer Costs are being managed through external partnerships. Brainstorm Cell Therapeutics Inc. signed a Letter of Intent (LOI) with Minaris Advanced Therapies, a global contract development and manufacturing organization (CDMO), specifically to manufacture NurOwn for this Phase 3b trial. While the specific Q3 2025 charge for this partnership isn't itemized separately from R&D, cash used in operating activities for the six months ended June 30, 2025, was $5,133,000, which was primarily attributed to costs including clinical trials, rent of clean room, and materials for clinical trials.

Legal and Regulatory Costs are ongoing as the company prepares for a potential Biologics License Application (BLA) submission based on Part A data. The company has been engaging with regulatory authorities, including following up on a Citizen Petition filed by the ALS community requesting a renewed review of NurOwn data. For context on legal spend, the SEC filing for the period ended June 30, 2025, noted that cash used for operating activities included outside legal fee expenses.

• The company reached alignment with the FDA on Chemistry, Manufacturing, and Controls (CMC) aspects of the Phase 3b trial in June 2024.
• The trial's primary efficacy measure is the change from baseline to Week 24 on the ALSFRS-R scale.

Brainstorm Cell Therapeutics Inc. (BCLI) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Brainstorm Cell Therapeutics Inc. as of late 2025. For a pre-revenue biotech, the current picture is stark, but the potential future streams are what drive the valuation. Honestly, the focus right now is entirely on clinical execution to unlock the first real revenue source.

Current Financial State and Pre-Revenue Status

As of the first quarter of 2025, Brainstorm Cell Therapeutics Inc. reported $0 in revenue. This is typical for a company deep in clinical development, as the primary focus is on generating the confirmatory data needed for regulatory submission, not sales. For the quarter ended March 31, 2025, the company reported a net loss of approximately $2.9 million. This loss reflects the ongoing Research and Development expenditures necessary to advance the NurOwn program.

Here's a quick look at the Q1 2025 financial context:

Metric	Amount (Q1 2025)
Reported Revenue	$0
Net Loss	$2.9 million
Cash & Equivalents (as of March 31, 2025)	Approximately $1.8 million

Future Product Sales

The primary, most significant revenue stream hinges on the successful commercialization of NurOwn for Amyotrophic Lateral Sclerosis (ALS). This requires clearing the Phase 3b ENDURANCE study, which is designed to enroll approximately 200 participants. The successful completion of the double-blind portion (Part A) is targeted to generate the clinical data necessary to support a Biologics License Application (BLA) submission. Direct sales revenue would commence only upon potential FDA approval for NurOwn.

Licensing/Partnership Revenue

Beyond the lead candidate, Brainstorm Cell Therapeutics Inc. has a secondary, high-potential revenue avenue in its proprietary, allogeneic exosome-based platform. This technology is being advanced to deliver therapeutic proteins and nucleic acids. Securing a foundational patent covering this technology strengthens the IP portfolio, making potential out-licensing deals more attractive. Strategic collaborations and expanded IP filings are currently in progress to build value in this platform.

Non-Dilutive Funding

To bridge the gap until potential product sales, the company actively pursues non-dilutive funding sources. You should note the pursuit of grants, which do not require giving up equity. Specifically, there is mention of a promising $15 million grant under review, which is critical for supporting operations and trial initiation. The company has a history of such support, including a $16 million grant from the California Institute for Regenerative Medicine (CIRM) awarded in 2017 to support a Phase 3 trial.

• Pursuit of a promising $15 million non-dilutive grant.
• Historical CIRM grant for Phase 3 support: $16 million (awarded 2017).
• Past support from Israel's OCS, including approximately $4.1 million cumulatively through 2014.

Equity Financing

Since operational funding is essential for clinical progression, capital raised through equity markets is a current, though dilutive, source of cash flow. In the period leading up to the first quarter of 2025, Brainstorm Cell Therapeutics Inc. secured capital through at-the-market offerings and warrant exercises. This financing activity contributed a total of $3.086 million to the company's cash position. This type of funding is a necessary mechanism to sustain operations while awaiting value inflection points from clinical milestones.

Finance: draft 13-week cash view by Friday.