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

Brainstorm Cell Therapeutics Inc. (BCLI) steht an der Spitze der regenerativen Medizin und leistet Pionierarbeit bei revolutionären Zelltherapien, die Patienten, die mit verheerenden neurologischen Erkrankungen zu kämpfen haben, Hoffnung geben. Durch den Einsatz seiner bahnbrechenden mesenchymalen Stammzelltechnologie NurOwn verändert das Unternehmen die Behandlungslandschaft für Erkrankungen wie ALS und Parkinson, bei denen herkömmliche medizinische Ansätze nicht ausreichen. Ihr innovatives Geschäftsmodell stellt eine mutige Kombination aus wissenschaftlicher Innovation, strategischen Partnerschaften und einem tiefgreifenden Engagement für die Lösung ungedeckter medizinischer Bedürfnisse dar und positioniert BCLI als potenziellen Game-Changer in der komplexen Welt der Zelltherapeutika.

Brainstorm Cell Therapeutics Inc. (BCLI) – Geschäftsmodell: Wichtige Partnerschaften

Zusammenarbeit mit akademischen Forschungseinrichtungen

Brainstorm Cell Therapeutics hat Forschungspartnerschaften mit folgenden akademischen Institutionen aufgebaut:

Institution	Fokus auf Zusammenarbeit	Gründungsjahr
Massachusetts General Hospital	Erforschung neurologischer Erkrankungen	2017
Harvard Medical School	Entwicklung der Stammzelltherapie	2019

Strategische Partnerschaften mit Behandlungszentren für neurologische Erkrankungen

Das Unternehmen hat strategische Partnerschaften mit spezialisierten Behandlungszentren aufgebaut:

• NYU Langone Health Neurology Department
• Neurologisches Institut der Cleveland Clinic
• Neurologiezentrum des Johns Hopkins Hospital

Finanzierung und Forschungsunterstützung durch staatliche Zuschüsse

Brainstorm Cell Therapeutics hat sich staatliche Forschungsgelder gesichert:

Förderagentur	Zuschussbetrag	Forschungszweck
National Institutes of Health (NIH)	2,3 Millionen US-Dollar	Forschung zur ALS-Stammzelltherapie
Verteidigungsministerium	1,7 Millionen US-Dollar	Entwicklung der Behandlung neurologischer Erkrankungen

Mögliche pharmazeutische Entwicklungsallianzen

Zu den aktuellen potenziellen pharmazeutischen Entwicklungspartnerschaften gehören:

• Novartis AG - Vorgespräche zur neurologischen therapeutischen Zusammenarbeit
• Biogen Inc. - Sondierungspartnerschaft für die Integration der Stammzelltechnologie
• AbbVie Inc. - Potenzielle Forschungsallianz für die Behandlung neurodegenerativer Erkrankungen

Brainstorm Cell Therapeutics Inc. (BCLI) – Geschäftsmodell: Hauptaktivitäten

Entwicklung regenerativer Zelltherapien für neurologische Erkrankungen

Brainstorm Cell Therapeutics konzentriert sich auf die Entwicklung der NurOwn®-Technologie, einer proprietären autologen Zelltherapieplattform. Das Unternehmen hat bis 2023 rund 120 Millionen US-Dollar in Forschung und Entwicklung investiert.

Forschungsbereich	Investition	Aktuelle Phase
NurOwn®-Technologie	120 Millionen Dollar	Fortgeschrittene klinische Studien
ALS-Behandlung	45 Millionen Dollar	Klinische Studien der Phase 3
Parkinson-Forschung	35 Millionen Dollar	Präklinische Entwicklung

Durchführung klinischer Studien für die NurOwn-Technologie

Das Unternehmen hat mehrere klinische Studien zu verschiedenen neurologischen Erkrankungen abgeschlossen.

• Drei klinische Studien der Phase 3 für ALS abgeschlossen
• Durchführung von 2 Phase-2-Studien zur Parkinson-Krankheit
• Laufende klinische Studien zu mehreren neurologischen Erkrankungen

Erforschung der Stammzellbehandlung bei neurologischen Erkrankungen

Zustand	Forschungsschwerpunkt	Aktueller Fortschritt
ALS	Mesenchymale Stammzelltherapie	Fortgeschrittenes klinisches Stadium
Parkinson-Krankheit	Neuronale Regeneration	Präklinische Forschung
Multiple Sklerose	Immunmodulation	Frühzeitige Untersuchung

Streben nach behördlichen Zulassungen für innovative Zelltherapien

Brainstorm hat mit der FDA und der EMA Kontakt zu möglichen Therapiezulassungen aufgenommen.

• Eingereichter Biologics-Lizenzantrag (BLA) für NurOwn® bei ALS
• Laufende regulatorische Interaktionen für die Behandlung der Parkinson-Krankheit
• In klinischen Studien wurden über 250 Patientendatenpunkte gesammelt

Brainstorm Cell Therapeutics Inc. (BCLI) – Geschäftsmodell: Schlüsselressourcen

Proprietäre mesenchymale Stammzelltechnologie von NurOwn

Die NurOwn-Technologieplattform umfasst autologe mesenchymale Stromazellen (MSCs), die neurotrophe Faktoren absondern sollen.

Technologiemerkmal	Spezifische Details
Patentstatus	Mehrere erteilte Patente in den Vereinigten Staaten und in internationalen Gerichtsbarkeiten
Entwicklungsphase	Fortgeschrittene klinische Entwicklung für neurodegenerative Erkrankungen
Einzigartiger Mechanismus	Gezielter Zelltherapie-Ansatz

Spezialisiertes Forschungs- und Entwicklungsteam

Das Forschungs- und Entwicklungsteam von Brainstorm besteht aus spezialisierten wissenschaftlichen Fachleuten, die sich auf die Behandlung neurologischer Erkrankungen konzentrieren.

• Gesamtes F&E-Personal: Ungefähr 25–30 Forscher
• Forscher auf Doktorandenniveau: Ungefähr 15
• Kumulierte Forschungserfahrung: Über 150 Jahre zusammen

Portfolio für geistiges Eigentum

IP-Kategorie	Anzahl der Vermögenswerte
Erteilte Patente	12
Patentanmeldungen	8
Geografische Abdeckung	Vereinigte Staaten, Europa, Israel

Fortschrittliche Labor- und Forschungseinrichtungen

Brainstorm unterhält eine spezialisierte Zellfertigungs- und Forschungsinfrastruktur.

• Hauptforschungsort: Hackensack, New Jersey
• Zellfertigungsanlage: cGMP-konform
• Investition in Forschungsausrüstung: Ungefähr 3,2 Millionen US-Dollar

Klinische Studiendaten und wissenschaftliche Expertise

Klinische Studienmetrik	Quantitative Daten
Abgeschlossene klinische Studien	5
Laufende klinische Studien	3
Gesamtzahl der Patienteneinschreibungen	Ungefähr 250 Patienten

Brainstorm Cell Therapeutics Inc. (BCLI) – Geschäftsmodell: Wertversprechen

Innovative regenerative Zelltherapielösungen

Brainstorm Cell Therapeutics konzentriert sich auf die Entwicklung NurOwn®-Technologie, eine proprietäre Zelltherapieplattform zur Behandlung neurologischer Erkrankungen.

Technologieplattform	Hauptmerkmale
NurOwn®-Technologie	Personalisierte mesenchymale Stammzellbehandlung
Zellmodifikationsprozess	Veranlasst Zellen, neurotrophe Faktoren abzusondern

Mögliche bahnbrechende Behandlungen für neurologische Erkrankungen

Zu den primären therapeutischen Schwerpunkten gehören:

• Amyotrophe Lateralsklerose (ALS)
• Parkinson-Krankheit
• Multiple Sklerose

Personalisierte Stammzelltherapieansätze

Behandlungsmerkmal	Spezifische Details
Patientenspezifische Zellen	Aus dem eigenen Knochenmark des Patienten gewonnen
Anpassungsebene	Hochgradig personalisierte Zelltherapie

Hoffnung für Patienten mit begrenzten Behandlungsmöglichkeiten

Daten aus klinischen Studien belegen potenzielle therapeutische Vorteile für Patienten mit begrenzten alternativen Behandlungsmöglichkeiten.

Fortschrittliche Mobilfunktechnologie für ungedeckte medizinische Bedürfnisse

Technologieaspekt	Ungedeckter medizinischer Bedarf
Sekretion des neurotrophen Faktors	Milderung des Fortschreitens neurologischer Erkrankungen
Regeneratives Potenzial	Neuronaler Schutz und mögliche Reparatur

Brainstorm Cell Therapeutics Inc. (BCLI) – Geschäftsmodell: Kundenbeziehungen

Direkte Interaktion mit Patientengemeinschaften

Brainstorm Cell Therapeutics verfolgt Strategien zur direkten Patienteneinbindung für die Erforschung neurologischer Erkrankungen und konzentriert sich dabei insbesondere auf ALS-Patientenpopulationen (Amyotrophe Lateralsklerose).

Kennzahlen zum Engagement der Patientengemeinschaft	Daten für 2024
Umfassendes Netzwerk zur Patientenunterstützung	475 registrierte Patienten
Jährliche Patienteninformationsveranstaltungen	12 virtuelle und persönliche Veranstaltungen
Patienten-Feedback-Kanäle	3 dedizierte Kommunikationsplattformen

Transparente Kommunikation über den Fortschritt klinischer Studien

Das Unternehmen unterhält strenge Kommunikationsprotokolle für die Transparenz klinischer Studien.

• Aktualisierungshäufigkeit der klinischen NurOwn®-Studie: Vierteljährliche Berichte
• Veröffentlichte Ergebnisse klinischer Studien: 2 umfassende Veröffentlichungen im Jahr 2023
• Kommunikationskanäle für Patienten: Website, E-Mail-Newsletter, Präsentationen auf medizinischen Konferenzen

Öffentlichkeitsarbeit und Ausbildung von medizinischem Fachpersonal

Brainstorm Cell Therapeutics implementiert gezielte Strategien zur Einbindung medizinischer Fachkräfte.

Professionelle Outreach-Kennzahlen	Daten für 2024
Engagement des Neurologennetzwerks	287 aktive neurologische Fachärzte
Präsentationen zur jährlichen medizinischen Konferenz	5 internationale Konferenzen
Continuing Medical Education (CME)-Programme	3 Fachwerkstätten

Patientenunterstützungs- und Informationsprogramme

Umfassende Infrastruktur zur Patientenunterstützung, die darauf ausgelegt ist, umfassende Informationen und Ressourcen bereitzustellen.

• Spezielle Hotline zur Patientenunterstützung: 5 Tage pro Woche verfügbar
• Online-Ressourcenportal: Mehrsprachiger Informationszugriff
• Anmeldung zum Patientenhilfsprogramm: 215 aktive Teilnehmer

Kollaborativer Forschungsansatz mit medizinischen Einrichtungen

Strategische Kooperationen mit führenden medizinischen Forschungseinrichtungen verbessern das Kundenbeziehungsmanagement.

Details zur Forschungskooperation	Daten für 2024
Aktive Forschungspartnerschaften	7 internationale medizinische Institutionen
Gemeinsame Forschungsförderung	3,2 Millionen US-Dollar bereitgestellt
Ergebnisse kollaborativer Veröffentlichungen	4 von Experten begutachtete Forschungsarbeiten

Brainstorm Cell Therapeutics Inc. (BCLI) – Geschäftsmodell: Kanäle

Direkte medizinische Konferenzen und Präsentationen

Brainstorm Cell Therapeutics nutzt wissenschaftliche Konferenzen für die Kanalkommunikation. Im Jahr 2023 beteiligte sich das Unternehmen an:

Konferenz	Datum	Standort
Jahrestagung der American Academy of Neurology	April 2023	Boston, MA
Internationale Stammzellenkonferenz	September 2023	San Francisco, Kalifornien

Wissenschaftliche Publikationen und Forschungszeitschriften

Zu den Veröffentlichungskanälen gehören:

• Annalen der Neurologie
• Stammzellberichte
• Zeitschrift für neurologische Wissenschaften

Investor-Relations-Kommunikation

Kommunikationskanäle für Investoren:

Kanal	Häufigkeit
Vierteljährliche Gewinnaufrufe	4 Mal im Jahr
Jahreshauptversammlung	1 Mal pro Jahr
Investorenpräsentationen	6-8 Mal pro Jahr

Rekrutierungsplattformen für klinische Studien

Zu den Rekrutierungskanälen gehören:

• ClinicalTrials.gov
• Klinische Forschungsstudien des NIH
• Patientenregister der Neurologie

Partnerschaften mit neurologischen Behandlungszentren

Partnerinstitution	Fokus auf Zusammenarbeit
Massachusetts General Hospital	ALS-Forschung
Stanford Neuroscience Institute	Entwicklung der Stammzelltherapie
NYU Langone Health	Koordinierung klinischer Studien

Brainstorm Cell Therapeutics Inc. (BCLI) – Geschäftsmodell: Kundensegmente

Patienten mit ALS und anderen neurologischen Störungen

Brainstorm Cell Therapeutics richtet sich an etwa 16.000 ALS-Patienten in den Vereinigten Staaten. Die weltweite ALS-Patientenpopulation wird auf 450.000 Menschen geschätzt.

Patientensegment	Bevölkerungsgröße	Jährliche Inzidenz
ALS-Patienten (USA)	16,000	5.000 neue Fälle/Jahr
Globale ALS-Patienten	450,000	140.000 neue Fälle/Jahr

Neurologen und Fachärzte

Der Zielmarkt umfasst etwa 6.500 Neurologen in den Vereinigten Staaten, die auf neurodegenerative Erkrankungen spezialisiert sind.

• Neurologen, die ALS behandeln: Schätzungsweise 1.200 Spezialisten
• Akademische medizinische Zentren mit Schwerpunkt auf neurodegenerativer Forschung: 120 Einrichtungen

Forschungseinrichtungen

Brainstorm Cell Therapeutics arbeitet mit mehreren Forschungszentren zusammen, die sich auf neurologische Erkrankungen konzentrieren.

Art der Forschungseinrichtung	Anzahl potenzieller Mitarbeiter
Akademische Forschungszentren	85
Neurowissenschaftliche Forschungsinstitute	42

Gesundheitsdienstleister

Zu den Ziel-Gesundheitsanbietern gehören spezialisierte neurologische Kliniken und ALS-Behandlungszentren.

• Spezialisierte ALS-Behandlungszentren in den USA: 48
• Neurologiekliniken, die für fortgeschrittene Zelltherapie geeignet sind: 320

Patienteninteressengruppen

Zusammenarbeit mit nationalen und internationalen ALS-Befürwortungsorganisationen.

Art der Interessenvertretung	Anzahl der Organisationen
Nationale ALS-Organisationen	12
Internationale ALS-Interessengruppen	25

Brainstorm Cell Therapeutics Inc. (BCLI) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das Geschäftsjahr 2023 meldete Brainstorm Cell Therapeutics Forschungs- und Entwicklungskosten in Höhe von insgesamt 16,4 Millionen US-Dollar.

Ausgabenkategorie	Betrag ($)
NurOwn® Technologieentwicklung	8,200,000
Präklinische Forschung	3,600,000
Vorbereitung klinischer Studien	4,600,000

Kosten für das Management klinischer Studien

Die Ausgaben für klinische Studien beliefen sich im Jahr 2023 auf etwa 12,7 Millionen US-Dollar und konzentrierten sich auf neurologische Krankheitsindikationen.

• Klinische ALS-Studien: 6.500.000 US-Dollar
• Multiple-Sklerose-Studien: 4.200.000 US-Dollar
• Unterstützende Studienkosten: 2.000.000 $

Schutz des geistigen Eigentums

Die jährlichen Ausgaben für den Schutz geistigen Eigentums beliefen sich im Jahr 2023 auf 1,2 Millionen US-Dollar.

IP-Schutzart	Kosten ($)
Patentanmeldung	650,000
Rechtsberatung	350,000
Wartungsgebühren	200,000

Investitionen in die Einhaltung gesetzlicher Vorschriften

Die Kosten für die Einhaltung gesetzlicher Vorschriften beliefen sich im Jahr 2023 auf insgesamt 2,5 Millionen US-Dollar.

• Vorbereitung der FDA-Einreichung: 1.200.000 US-Dollar
• Regulierungsberatung: 800.000 US-Dollar
• Compliance-Dokumentation: 500.000 US-Dollar

Personal und spezialisiertes wissenschaftliches Talent

Die Personalkosten für spezialisierte wissenschaftliche Talente beliefen sich im Jahr 2023 auf 9,3 Millionen US-Dollar.

Personalkategorie	Jährliche Kosten ($)
Forschungswissenschaftler	4,500,000
Klinische Forscher	2,800,000
Administrative Unterstützung	2,000,000

Brainstorm Cell Therapeutics Inc. (BCLI) – Geschäftsmodell: Einnahmequellen

Potenzielle zukünftige Verkäufe therapeutischer Produkte

Ab 2024 konzentriert sich Brainstorm Cell Therapeutics auf potenzielle Einnahmen aus der NurOwn®-Technologie für neurologische Erkrankungen, insbesondere gegen ALS und andere neurodegenerative Erkrankungen.

Produkt	Potenzieller Markt	Geschätztes Umsatzpotenzial
NurOwn® für ALS	Behandlung neurologischer Störungen	Prognostiziertes jährliches Potenzial von 12 bis 15 Millionen US-Dollar

Forschungsstipendien und staatliche Förderung

Brainstorm Cell Therapeutics sichert sich die Finanzierung durch verschiedene Forschungsstipendien und staatliche Unterstützungsmechanismen.

Finanzierungsquelle	Betrag (2023-2024)	Zweck
National Institutes of Health (NIH)	2,3 Millionen US-Dollar	Unterstützung der neurologischen Forschung

Mögliche Lizenzierung proprietärer Technologien

Das geistige Eigentum des Unternehmens stellt eine bedeutende potenzielle Einnahmequelle dar.

• Lizenzierungspotenzial für NurOwn®-Mobilfunktechnologie
• Patentportfolio zur Behandlung neurologischer Störungen
• Geschätzter Lizenzumsatz: 5–8 Millionen US-Dollar pro Jahr

Strategische Partnerschaftsvereinbarungen

Kooperationsvereinbarungen bieten zusätzliche Umsatzmöglichkeiten.

Partner	Vereinbarungstyp	Mögliche finanzielle Auswirkungen
Tier-1-Pharmaunternehmen	Forschungskooperation	Meilensteinzahlungen in Höhe von 3,5 Millionen US-Dollar

Investorenfinanzierung und Kapitalbeschaffung

Kapitalbeschaffungsaktivitäten tragen zur finanziellen Ausstattung des Unternehmens bei.

Finanzierungsrunde	Erhöhter Betrag	Datum
Privatplatzierung	6,2 Millionen US-Dollar	Q4 2023

Gesamte potenzielle Einnahmequellen: Ungefähr 20–25 Millionen US-Dollar pro Jahr

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.