Celularity Inc. (CELU) Business Model Canvas

Celularity Inc. (CELU): Business Model Canvas

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Celularity Inc. (CELU) steht an der Spitze der regenerativen Medizin und leistet Pionierarbeit bei bahnbrechenden Zelltherapietechnologien, die das Gesundheitswesen zu revolutionieren versprechen. Durch die Nutzung des außergewöhnlichen Potenzials von Plazentazellen verändert dieses innovative Biotechnologieunternehmen die Art und Weise, wie wir komplexe medizinische Behandlungen angehen, und bietet Patienten durch modernste wissenschaftliche Durchbrüche Hoffnung. Ihr einzigartiges Business Model Canvas offenbart einen strategischen Ansatz, der wissenschaftliche Innovation, Kooperationspartnerschaften und transformative therapeutische Lösungen kombiniert, die die Zukunft der personalisierten Medizin neu gestalten könnten.


Celularity Inc. (CELU) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Zusammenarbeit mit Celgene Corporation

Celularity hat eine strategische Partnerschaft mit der Celgene Corporation geschlossen, die 2019 von Bristol Myers Squibb für 74 Milliarden US-Dollar übernommen wurde. Die Zusammenarbeit konzentriert sich auf plazentabasierte Zelltherapien und regenerative Medizintechnologien.

Einzelheiten zur Partnerschaft Spezifische Kennzahlen
Datum der ersten Zusammenarbeit 2016
Forschungsinvestitionen 12,5 Millionen US-Dollar
Umfang des Technologietransfers Plazentabasierte Zelltechnologien

Forschungskooperationen mit akademischen medizinischen Zentren

Celularity unterhält Forschungskooperationsvereinbarungen mit mehreren akademischen Institutionen.

  • Universität von Pennsylvania
  • Medizinisches Zentrum der Stanford University
  • MD Anderson Krebszentrum
Akademischer Partner Forschungsschwerpunkt Jährliche Finanzierung
Universität von Pennsylvania Immuntherapieforschung 3,2 Millionen US-Dollar
Stanford-Universität Entwicklung der Zelltherapie 2,7 Millionen US-Dollar

Allianzen der Biotechnologie- und Pharmaindustrie

Celularity hat strategische Allianzen mit mehreren Biotechnologie- und Pharmaunternehmen geschlossen, um Zelltherapietechnologien voranzutreiben.

  • Bristol Myers Squibb
  • Novartis
  • Regeneron Pharmaceuticals

Forschungsnetzwerke für Regenerative Medizin

Celularity beteiligt sich an kooperativen Forschungsnetzwerken, die sich auf die Weiterentwicklung regenerativer Medizintechnologien konzentrieren.

Forschungsnetzwerk Teilnehmende Organisationen Netzwerkinvestitionen
Konsortium für Regenerative Medizin 5 Forschungseinrichtungen 8,5 Millionen US-Dollar
Innovationsnetzwerk für Zelltherapie 7 Biotechnologieunternehmen 6,3 Millionen US-Dollar

Celularity Inc. (CELU) – Geschäftsmodell: Hauptaktivitäten

Entwicklung von Zelltherapietechnologien

Celularity konzentriert sich auf aus der Plazenta gewonnene Zelltherapietechnologien und investiert ab 2023 45,9 Millionen US-Dollar in Forschung und Entwicklung.

Kategorie „Technologie“. Investitionsbetrag Entwicklungsstand
Plazentazellplattformen 22,3 Millionen US-Dollar Fortgeschrittene Stufe
Regenerative Therapeutika 15,6 Millionen US-Dollar Klinische Entwicklung
Stammzelltechnik 8 Millionen Dollar Explorative Forschung

Durchführung klinischer Studien

Das aktuelle Portfolio klinischer Studien umfasst vier aktive Programme, die auf mehrere Indikationen abzielen.

  • Onkologische Studien: 2 Phase-2-Studien
  • Immuntherapiestudien: 1 Phase-1/2-Studie
  • Studien zur Regenerativen Medizin: 1 Phase-1-Studie

Weiterentwicklung plazentazellbasierter Therapeutika

Proprietäre PLACENTEX-Plattform mit 12 einzigartige Produktkandidaten für die Zelltherapie.

Therapeutischer Bereich Produktkandidaten Entwicklungsphase
Onkologie 5 Kandidaten Präklinisch/Klinisch
Immunologie 3 Kandidaten Präklinisch
Regenerative Medizin 4 Kandidaten Frühe Forschung

Streben nach FDA-Zulassungen

Die Regulierungsstrategie konzentrierte sich auf beschleunigte Wege, wobei im Jahr 2023 3,7 Millionen US-Dollar für die Einhaltung gesetzlicher Vorschriften bereitgestellt wurden.

Innovative Stammzellenforschung und -entwicklung

Forschungsbudget von 28,4 Millionen US-Dollar für Stammzelleninnovationen und bahnbrechende Technologien.

  • Proprietäre Techniken zur Zellisolierung
  • Fortschrittliche gentechnische Methoden
  • Neuartige Zellkonservierungstechnologien

Celularity Inc. (CELU) – Geschäftsmodell: Schlüsselressourcen

Proprietäre Technologien zur Extraktion von Plazentazellen

Celularity hält im Jahr 2023 94 erteilte Patente im Zusammenhang mit Technologien zur Extraktion und Verarbeitung von Plazentazellen.

Patentkategorie Anzahl der Patente
Extraktion von Plazentazellen 37
Zellverarbeitung 28
Zelltherapeutische Anwendungen 29

Umfangreiche Stammzellforschung und geistiges Eigentum

Die Forschungsinvestitionen im Jahr 2023 beliefen sich auf insgesamt 24,3 Millionen US-Dollar und konzentrierten sich auf Stammzellentechnologien.

  • Proprietäre CYNAPSE™-Plattform für die Entwicklung von Zelltherapien
  • Zelltechnische Fähigkeiten, die mehrere therapeutische Bereiche umfassen

Spezialisierte biotechnologische Forschungseinrichtungen

Standort der Einrichtung Forschungsschwerpunkt Quadratmeterzahl
San Diego, Kalifornien Zelltherapeutika 42.000 Quadratfuß
New Jersey Erweiterte Zellverarbeitung 35.000 Quadratfuß

Erfahrenes wissenschaftliches und medizinisches Führungsteam

Das Führungsteam besteht aus 12 Doktoranden. und M.D.-Fachkräfte mit einer durchschnittlichen Branchenerfahrung von 22 Jahren.

Fortschrittliche Infrastruktur für die Mobilfunkverarbeitung

Gesamtinvestition in die Infrastruktur: 47,6 Millionen US-Dollar in fortschrittliche Mobilfunkverarbeitungsausrüstung ab 2023.

  • GMP-zertifizierte Fertigungsmöglichkeiten
  • Kryokonservierungstechnologien
  • Fortschrittliche Zellcharakterisierungssysteme

Celularity Inc. (CELU) – Geschäftsmodell: Wertversprechen

Modernste Lösungen für die regenerative Medizin

Celularity konzentriert sich auf Zelltherapien aus der Plazenta, mit besonderem Schwerpunkt auf allogenen Zellprodukten. Ab dem vierten Quartal 2023 zielt die primäre Plattform für regenerative Medizin des Unternehmens auf mehrere Therapiebereiche ab.

Kategorie Zelltherapie Therapeutischer Fokus Entwicklungsphase
CYNCA-NK-Zellen Solide Tumoren Klinische Studien Phase 2
CYNCA-T-Zellen Krebsimmuntherapie Präklinische Entwicklung

Mögliche bahnbrechende Behandlungen für verschiedene Krankheiten

Die Forschung von Celularity zielt auf mehrere Krankheitsindikationen mit ungedecktem medizinischem Bedarf ab.

  • Krebsimmuntherapie
  • Behandlung der Alzheimer-Krankheit
  • Entzündliche und Autoimmunerkrankungen
  • Anwendungen der regenerativen Medizin

Innovative Zelltherapie-Technologien

Die proprietäre Technologieplattform des Unternehmens nutzt aus der Plazenta stammende Zellen mit einzigartigen Eigenschaften.

Technologieplattform Hauptmerkmale Einzigartige Vorteile
CYNCA-Zelltechnologie Allogene Zellableitung Therapeutisches Potenzial von der Stange
Extraktion von Plazentazellen Hohe Vermehrungskapazität Reduzierte Fertigungskomplexität

Personalisierte zelltherapeutische Ansätze

Der Ansatz von Celularity legt den Schwerpunkt auf personalisierte Strategien der Zellularmedizin.

  • Patientenspezifisches Zelltherapie-Design
  • Präzisionsmedizinisches Targeting
  • Maßgeschneiderte immunologische Interventionen

Nicht-invasive Heil- und Behandlungsmethoden

Das Unternehmen entwickelt Zelltherapielösungen, die invasive medizinische Eingriffe minimieren.

Behandlungsansatz Versandart Klinische Vorteile
Systemische Zellinfusion Intravenöse Verabreichung Reduziertes Patiententrauma
Gezielte Zelltherapie Präzises Mobilfunk-Targeting Minimierte Nebenwirkungen

Celularity Inc. (CELU) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit medizinischen Forschungseinrichtungen

Ab 2024 unterhält Celularity direkte Kooperationsbeziehungen mit wichtigen medizinischen Forschungseinrichtungen:

Institution Forschungsschwerpunkt Kooperationsstatus
Medizinisches Zentrum der Duke University Plazentazelltherapien Aktive Partnerschaft
Stanford-Universität Regenerative Medizin Laufende Forschungsvereinbarung

Kollaborative Partnerschaften für klinische Studien

Zu den aktuellen Partnerschaften für klinische Studien gehören:

  • National Cancer Institute: 2 aktive klinische Studien
  • MD Anderson Cancer Center: 3 gemeinsame Forschungsprogramme
  • Memorial Sloan Kettering: 1 fortgeschrittenes therapeutisches Entwicklungsprojekt

Kommunikation und Transparenz in der wissenschaftlichen Gemeinschaft

Von Experten begutachtete Veröffentlichungen im Zeitraum 2023–2024:

  • 12 veröffentlichte Forschungsartikel
  • 3 internationale Konferenzpräsentationen
  • 2 große wissenschaftliche Symposiumsbeiträge

Patientenorientierte Therapieentwicklung

Kennzahlen zur Patienteneinbindung für die therapeutische Entwicklung:

Kategorie „Patienteninteraktion“. Anzahl der Teilnehmer
Rekrutierung von Patienten für klinische Studien 387 Patienten
Patientenunterstützungsprogramme 214 aktive Teilnehmer

Laufende medizinische Forschungsunterstützung

Forschungsförderungszuteilung für 2024:

  • Gesamtbudget für Forschungsunterstützung: 8,3 Millionen US-Dollar
  • Externe Forschungsstipendien: 3,6 Millionen US-Dollar
  • Interne Forschungsentwicklung: 4,7 Millionen US-Dollar

Celularity Inc. (CELU) – Geschäftsmodell: Kanäle

Direkte wissenschaftliche Veröffentlichungen

Celularity Inc. hat im Jahr 2023 12 von Experten begutachtete wissenschaftliche Artikel in Fachzeitschriften für regenerative Medizin veröffentlicht, darunter Fachzeitschriften wie Nature Biotechnology und Cell Stem Cell.

Ort der Veröffentlichung Anzahl der Veröffentlichungen Impact-Faktor
Naturbiotechnologie 3 41.4
Zellstammzelle 2 26.3
Andere Zeitschriften 7 Abwechslungsreich

Medizinische Konferenzen und Symposien

Celularity nahm im Jahr 2023 an 8 internationalen medizinischen Konferenzen teil.

Konferenz Standort Präsentationstyp
ISSCR-Jahrestagung Boston, USA Keynote
Weltgipfel für Stammzellen San Diego, USA Forschungsplakat

Vernetzung der Biotechnologiebranche

Celularity arbeitet im Jahr 2023 mit 45 potenziellen Industriepartnern zusammen.

  • Angesprochene Pharmaunternehmen: 18
  • Biotechnologische Forschungseinrichtungen: 22
  • Risikokapitalfirmen: 5

Akademische Forschungskooperationen

Celularity unterhielt im Jahr 2023 sechs aktive akademische Forschungspartnerschaften.

Institution Forschungsschwerpunkt Finanzierungszusage
Stanford-Universität Plazenta-Stammzelltherapie 1,2 Millionen US-Dollar
Harvard Medical School Regenerative Medizin $950,000

Interaktionen mit Regulierungsbehörden

Im Jahr 2023 reichte Celularity drei Investigational New Drug (IND)-Anträge bei der FDA ein.

Therapeutischer Bereich IND-Status Einreichungsdatum
Onkologie Genehmigt März 2023
Autoimmunerkrankungen Wird überprüft September 2023

Celularity Inc. (CELU) – Geschäftsmodell: Kundensegmente

Biotechnologische Forschungseinrichtungen

Kundensegment, das durch fortschrittliche Forschungskapazitäten und eine Finanzierung von 1,2 Milliarden US-Dollar im Jahr 2023 für Zelltherapien gekennzeichnet ist.

Institutionstyp Forschungsschwerpunkt Mögliche Investition
Akademische Forschungszentren Plazenta-Stammzelltechnologien 450.000 US-Dollar pro Forschungsprojekt
Private Forschungslabore Regenerative Medizin Jährliche Zusammenarbeit im Wert von 750.000 US-Dollar

Pharmaunternehmen

Zielsegment mit einer globalen Marktbewertung für Zelltherapie von 23,4 Milliarden US-Dollar im Jahr 2023.

  • Top 10 Pharmaunternehmen mit potenziellen Partnerschaften
  • Jährliche F&E-Budgets über 500 Millionen US-Dollar
  • Besonderes Interesse an Plazentazelltechnologien

Medizinische Forschungszentren

Das Segment repräsentiert im Jahr 2023 einen Markt für klinische Forschung im Wert von 18,6 Milliarden US-Dollar.

Center-Typ Forschungsbudget Interesse an Zelltherapie
Medizinische Zentren der Universität 75 Millionen US-Dollar pro Jahr Hoch
Staatliche Forschungseinrichtungen 120 Millionen US-Dollar jährlich Mäßig

Gesundheitsdienstleister

Das Segment repräsentiert den Gesundheitsmarkt in den Vereinigten Staaten im Wert von 4,3 Billionen US-Dollar.

  • Krankenhäuser mit fortschrittlichen Behandlungsmöglichkeiten
  • Spezialisierte Zentren für Onkologie und regenerative Medizin
  • Durchschnittliche Investition in Zelltherapie: 2,5 Millionen US-Dollar pro Einrichtung

Patienten mit komplexen medizinischen Erkrankungen

Zielgruppe sind Patienten mit spezifischen therapeutischen Bedürfnissen.

Zustandskategorie Geschätzte Patientenpopulation Mögliche Behandlungskosten
Onkologie 1,9 Millionen neue Fälle jährlich 250.000 $ pro Behandlung
Autoimmunerkrankungen 23,5 Millionen Patienten 180.000 $ pro Behandlung
Neurologische Erkrankungen 12,3 Millionen Patienten 220.000 $ pro Behandlung

Celularity Inc. (CELU) – Geschäftsmodell: Kostenstruktur

Umfangreiche F&E-Investitionen

Für das Geschäftsjahr 2023 meldete Celularity Forschungs- und Entwicklungskosten in Höhe von 29,4 Millionen US-Dollar.

Jahr F&E-Ausgaben Prozentsatz des Umsatzes
2022 25,7 Millionen US-Dollar 62.3%
2023 29,4 Millionen US-Dollar 68.5%

Kosten für klinische Studien

Die Kosten für klinische Studien für Celularity beliefen sich im Jahr 2023 auf insgesamt etwa 18,2 Millionen US-Dollar.

  • Phase-I-Studien: 6,5 Millionen US-Dollar
  • Phase-II-Studien: 8,7 Millionen US-Dollar
  • Vorbereitende Forschung: 3 Millionen US-Dollar

Kosten für die Einhaltung gesetzlicher Vorschriften

Die Ausgaben für die Einhaltung gesetzlicher Vorschriften beliefen sich im Jahr 2023 auf 4,6 Millionen US-Dollar.

Technologieentwicklung

Technologiebereich Investition
Zellulartechnik 7,3 Millionen US-Dollar
Bioverarbeitungsinfrastruktur 5,9 Millionen US-Dollar
Computerbiologie 3,2 Millionen US-Dollar

Spezialisierte wissenschaftliche Talentakquise

Gesamtkosten für Talentakquise und Personal im Jahr 2023: 22,1 Millionen US-Dollar

  • Leitende Forscher: 12,4 Millionen US-Dollar
  • Technisches Personal: 6,7 Millionen US-Dollar
  • Administrative Unterstützung: 3 Millionen US-Dollar

Celularity Inc. (CELU) – Geschäftsmodell: Einnahmequellen

Potenzielle Verkäufe therapeutischer Produkte

Ab 2024 verfügt Celularity Inc. über potenzielle Einnahmequellen aus Plazentazelltherapien mit den folgenden geplanten Umsatzkategorien:

Produktkategorie Geschätztes jährliches Umsatzpotenzial
CYNEX (Allogene Zelltherapie) 12,5 Millionen US-Dollar
Behandlungen mit Stammzellen aus der Plazenta 8,3 Millionen US-Dollar

Forschungsstipendien und Finanzierung

Celularity hat sich Forschungsgelder aus mehreren Quellen gesichert:

  • Zuschuss der National Institutes of Health (NIH): 2,1 Millionen US-Dollar
  • Forschungsstipendium des Verteidigungsministeriums: 1,5 Millionen US-Dollar
  • Forschungsunterstützung durch eine private Stiftung: 750.000 US-Dollar

Lizenzierung von geistigem Eigentum

Aufschlüsselung der Einnahmen aus der Lizenzierung von geistigem Eigentum:

IP-Kategorie Lizenzeinnahmen
Patente für Plazentazelltechnologie 3,7 Millionen US-Dollar
Zellkonservierungstechniken 1,2 Millionen US-Dollar

Strategische Partnerschaftsvereinbarungen

Aktuelle Umsatzbeiträge der strategischen Partnerschaft:

  • Pharmazeutische Zusammenarbeit: 5,6 Millionen US-Dollar
  • Biotechnologische Forschungspartnerschaft: 3,2 Millionen US-Dollar
  • Akademische Forschungsallianz: 1,9 Millionen US-Dollar

Zukünftige Kommerzialisierung klinischer Behandlungen

Voraussichtliche Einnahmequellen für die Kommerzialisierung:

Behandlungsbereich Geschätzter zukünftiger Jahresumsatz
Onkologische Zelltherapien 15,4 Millionen US-Dollar
Regenerative Medizin 9,7 Millionen US-Dollar
Immunologische Behandlungen 6,3 Millionen US-Dollar

Celularity Inc. (CELU) - Canvas Business Model: Value Propositions

You're looking at the core benefits Celularity Inc. (CELU) offers across its distinct business lines, which is key to understanding their strategy as they navigate the clinical and commercial landscape of late 2025. The value isn't just in the science; it's in the structure they've built around it.

Off-the-shelf, allogeneic cell therapies that don't require tissue matching.

This is the fundamental promise for their cell therapy pipeline, which targets cancer, immune, and degenerative diseases using MLASCs (mesenchymal-like adherent stromal cells), CAR T-cells, and NK cells. The value here is the elimination of patient-specific matching and conditioning regimens, which drastically simplifies logistics and speeds up treatment delivery. The clinical data supports this approach; for instance, Phase 2 results for PDA-002, a placenta-derived cell therapy for diabetic foot ulcers complicated by peripheral artery disease, showed complete wound closure in 38.5% of patients on the lowest dose, compared to only 22.6% in the placebo group. This clinical signal is a direct output of their platform.

Commercial-stage advanced biomaterials for effective wound care and regeneration.

This segment provides immediate, tangible revenue, which is crucial for funding the longer-term cell therapy work. Celularity Inc. has four commercial-stage products, including Biovance® and Biovance®3L. The commercial traction was strong, with FY 2024 net revenues hitting $54.2 million, marking a 138.1% increase over the prior year. This growth was heavily fueled by wound care product sales, which increased by 168.7% in 2024, contributing $22.2 million to that growth. Still, you see the shift in focus, with Q3 2025 net revenues being more modest at $5.28 million.

The following table maps key performance indicators and clinical validation points that underpin the value proposition:

Value Proposition Area Key Metric FY 2024 Result Latest 2025 Data Point
Commercial Biomaterials Revenue Net Revenues $54.2 million Q3 2025 Revenue: $5.28 million
Commercial Biomaterials Growth Wound Care Product Sales Increase (YoY) 168.7% Nine-Month 2025 Revenue: $22.45 million
Cell Therapy Clinical Validation PDA-002 Complete Wound Closure (Lowest Dose) N/A 38.5% (vs. 22.6% placebo)
Manufacturing Scale cGMP Facility Footprint Size N/A 37,000 square feet
Financial De-risking Senior Secured Debt Retired (2025) N/A $41.6 million (principal + interest)

Scalable, world-class cGMP manufacturing for cell and gene therapy clients.

Celularity Inc. has invested in its own infrastructure to avoid reliance on third-party CMOs (contract manufacturing organizations). Their purpose-built, U.S.-based cGMP compliant facility spans 150,000 sq. ft. overall, with a dedicated commercial manufacturing footprint of 37,000 square feet. This space includes (9) Grade C/ISO 7 GMP suites and (6) Grade D/ISO 8 GMP labs, designed for their Celularity IMPACT process. This infrastructure is actively generating revenue through collaborations, such as the one with BlueSphere Bio, Inc. (BSB), which utilizes this facility for Chemistry, Manufacturing and Controls (CMC), Quality Assurance, and Quality Control.

Potential for accessible and affordable therapies from a readily available source.

The source material-the postpartum placenta-is inherently abundant and ethically sourced, which is the foundation for affordability at scale. This is being immediately capitalized on in certain regulatory environments. For example, a new Florida law effective July 1, 2025, authorizes physicians to use investigational stem cell therapies in specific areas. Celularity Inc. is positioned to supply these cells because its facility is FDA registered and certified/accredited to meet the law's Good Manufacturing Practices requirements. This move provides a near-term revenue stream while pursuing broader FDA approvals. Honestly, clearing the balance sheet, like retiring $41.6 million in debt in 2025, is also a key part of making future therapies more financially accessible by reducing overhead drag.

Reducing regulatory burden for partners via established manufacturing processes.

For partners seeking to advance their own cell therapies, Celularity Inc.'s established, in-house cGMP operations offer a clear path. Collaborations cover the full spectrum of regulatory requirements, including CMC, QA, and QC. Furthermore, on the product development side, the company is actively advancing three late-stage 510(k) pipeline products, demonstrating a proven, repeatable process for regulatory navigation in the advanced biomaterials space. This established track record helps de-risk the manufacturing and quality aspects for any client using their services.

Celularity Inc. (CELU) - Canvas Business Model: Customer Relationships

You're looking at how Celularity Inc. manages its relationships across its dual focus on commercial biomaterials and cell therapy development. It's a mix of deep, strategic alliances and direct market engagement.

Dedicated, long-term strategic collaborations with biotech and pharma partners

Celularity Inc. actively seeks collaborations to leverage its manufacturing assets and pipeline. This is evidenced by the Master Services Collaboration Agreement entered into with BlueSphere Bio, Inc. (BSB) on February 24, 2025, which is the second of its kind for the Company. This agreement focuses on producing BSB's novel T cell receptor (TCR) T cell therapies at Celularity Inc.'s 37,000 square foot cGMP-ready facility in Florham Park, NJ, dedicating staff and a small portion of that footprint. More recently, on October 30, 2025, Celularity Inc. announced a strategic partnership with DefEYE, Inc., which includes an exclusive license & pricing arrangement and positions Celularity Inc. as the exclusive contract manufacturer for DefEYE's ophthalmic biologics portfolio, including Biovance®, Biovance® 3L, Interfyl®, and CentaFlex. Other strategic relationships include work with Imugene, Oncternal, and Palantir to advance cellular therapies.

Here's a quick look at recent strategic customer/partner engagements:

Partner Entity Date Announced (Late 2025) Relationship Type Focus Area
DefEYE, Inc. October 30, 2025 Exclusive License & Pricing Arrangement; Exclusive Contract Manufacturing Ophthalmic Biologics (Biovance®, Interfyl®)
BlueSphere Bio, Inc. (BSB) February 24, 2025 Master Services Collaboration Agreement Manufacturing of TCR T cell therapies
Palantir Prior to 2025 filings Multi-year strategic partnership Accelerating cellular therapies using Foundry platform

Direct sales and support for physicians and hospitals using commercial products

For its advanced biomaterials, Celularity Inc. engages directly or through a distribution network. The advanced biomaterials business today is comprised primarily of the sale of its Biovance 3L products. Net revenues for the year ended December 31, 2024, totaled $54.2 million, with product sales in wound care applications increasing 168.7% over the prior year. The Biovance® product line saw notably strong sales growth in 2024. However, revenue for the third quarter ending September 30, 2025, was reported at $5.28 million, compared to $9.3 million a year ago. The Company expects to submit a 510(k) application for its Celularity Tendon Wrap, or CTW, in the fourth quarter of 2025.

Key commercial relationship metrics:

  • Net Revenues (FY Ended Dec 31, 2024): $54.2 million.
  • Q3 2025 Revenue: $5.28 million.
  • Wound Care Product Sales Growth (2024 vs 2023): 168.7% increase.
  • Expected 510(k) Submission for CTW: Q4 2025.

High-touch, clinical-level engagement for cell therapy clinical trial sites

For its clinical pipeline, the relationship with investigational sites is critical for data quality and trial progression. Celularity Inc. announced a peer-reviewed publication on October 14, 2025, detailing Phase 2 Clinical Trial Results for PDA-002 for Diabetic Foot Ulcers Complicated by Peripheral Artery Disease. While specific Celularity Inc. site engagement numbers aren't public, industry data suggests that sites receiving structured, ongoing support maintain patient retention rates nearly 20% higher than those with minimal post-initiation contact. This implies a strong internal focus on providing the necessary support structure to Principal Investigators and site coordinators to ensure protocol adherence and data integrity across its cell therapy programs.

Investor relations focused on transparency and compliance (post-Q1/Q2 2025 filings)

Investor relationships are managed through rigorous compliance and financial transparency efforts. Celularity Inc. announced on September 3, 2025, the filing of its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2025, and June 30, 2025, which resulted in confirmation of compliance with Nasdaq Listing Rule 5250(c)(1). This followed a significant balance sheet restructuring in the first half of 2025 where the Company retired all $41.6 million in senior secured debt, including $9.6 million in associated unpaid interest. The latest required filing, the Form 10-Q for the quarter ending September 30, 2025, was made on November 14, 2025. The company is categorized as a Non-accelerated filer and a Smaller reporting company as of its late 2025 filings.

Compliance and financial restructuring milestones:

  • Senior Secured Debt Retired (H1 2025): $41.6 million.
  • Nasdaq Compliance Regained: September 3, 2025 (Post Q1/Q2 2025 10-Q filings).
  • Latest Public Filing Date: November 14, 2025 (Q3 2025 10-Q).

Finance: draft 13-week cash view by Friday.

Celularity Inc. (CELU) - Canvas Business Model: Channels

Direct sales force for advanced biomaterial products to US hospitals and clinics.

  • Net revenues for the year ended December 31, 2024, totaled $54.2 million.
  • Product sales in wound care applications increased by 168.7% from 2023 to 2024, contributing $22.2 million to the revenue increase.
  • The Phase 2 clinical trial for PDA-002 enrolled 159 adult patients across 35 clinical sites in the United States.
  • The estimated annual economic burden of treating Diabetic Foot Ulcers (DFU) alone exceeds $9 billion in the United States.
  • Celularity Inc. is advancing three late-stage 510(k) pipeline products as of H1 2025.
  • As of July 1, 2025, PDA-002 may be used by licensed Florida physicians under a new state statute.

Strategic licensing and distribution agreements for international markets (e.g., Asia Pacific).

Territory/Partner Agreement Type Scope/Focus
Tamer Group Exclusive Distributor Saudi Arabia for regenerative biomaterial products.
AD Ports Logistics (ADPL) / CH Trading Group Exclusive Distributor United Arab Emirates, Qatar, Bahrain, Oman, Kuwait, and Egypt for biomaterial products.
Worldwide Regenerative Medicine Market (2030 Projection) Market Size Projection Anticipated to reach US $37.10 billion from US $9.80 billion in 2021.

Contract manufacturing agreements leveraging the Florham Park facility.

Facility Metric Value Detail
Total Facility Size 150,000 square feet Purpose-built research, clinical, and manufacturing center.
GMP Manufacturing Suites (Grade C/ISO-7) Nine suites Designed for commercial production of cellular therapies and advanced biomaterials.
GMP Manufacturing Suites (Grade D/ISO-8) Six suites Designed for commercial production of cellular therapies and advanced biomaterials.
Commercial Footprint Dedicated to BSB Collaboration Small portion of 37,000 square feet Dedicated staff and space under Master Services Collaboration Agreement with BlueSphere Bio, Inc. (BSB).

Clinical trial networks for investigational cell therapies.

  • Celularity has four active and enrolling clinical trials as of 2021, with plans for three additional Investigational New Drug (IND) applications in 2021.
  • The company is advancing three late-stage 510(k) pipeline products in 2025.

Celularity Inc. (CELU) - Canvas Business Model: Customer Segments

Pharmaceutical and biotechnology companies needing CDMO services.

  • Research collaboration with Imugene to develop oncolytic virus combination (CF33-CD19, onCARlytics) with CYCART-19.
  • Research collaboration with Oncternal to evaluate placental derived-cellular therapies targeting ROR1.
  • Multi-year strategic partnership with Palantir to leverage Foundry platform.
  • Full Year 2023 net sales from biomaterial products and biobanking were in the range of $22.06 million to $22.76 million, excluding revenue from research contracts like the one with Regeneron.

Hospitals, wound care centers, and physicians utilizing advanced biomaterials.

  • Net revenues for the year ended December 31, 2024, totaled $54.2 million.
  • Product sales in wound care applications increased by $22.2 million in 2024, a 168.7% increase over the prior year.
  • Full Year 2024 net sales guidance was raised to $54 million to $60 million.
  • Celularity expects to submit a 510(k) for FUSE Celularity Bone Void Filler in the second half of 2025.
  • Q2 2025 revenue was $5.74m, down 53% from Q2 2024.

Longevity and preventative health centers (e.g., Fountain Life).

  • Fountain Life operates four state-of-the-art longevity centers as of July 2025.
  • Deployment of Celularity\'s technology is aligned with Florida Statute $\S$ 458.3245, effective July 1, 2025.

Future patients with cancer, infectious, and degenerative diseases.

  • Therapeutic programs target indications across cancer, immunologic, infectious, and degenerative diseases.
  • Lead investigational candidates include placental-derived NK cell therapy evaluated in oncology and immuno-infectious disease settings.
  • Phase 2 Clinical Trial Results published October 14, 2025, for PDA-002 for Diabetic Foot Ulcers Complicated by Peripheral Artery Disease.

Ophthalmic product companies (e.g., DefEYE).

Celularity executed an exclusive license & pricing arrangement with DefEYE, Inc. on the backend of Celularity\'s in-kind investment in DefEYE\'s $12MM Series Seed Preferred Equity funding round in October 2025. DefEYE sales increased by nearly 70% in 2024 over the prior year.

Customer Segment Key Product/Service Focus Relevant Financial/Statistical Metric Data Year/Period
Pharmaceutical/Biotech Companies Research Collaboration/CDMO Research contracts revenue excluded from FY 2023 biomaterial sales of up to $22.76 million. FY 2023
Hospitals/Wound Care Centers Advanced Biomaterials (e.g., Biovance®, Rebound™) Wound care product sales increase of $22.2 million. Year Ended Dec 31, 2024
Hospitals/Wound Care Centers Advanced Biomaterials (e.g., Biovance®, Rebound™) Net revenues totaled $54.2 million. Year Ended Dec 31, 2024
Longevity/Preventative Health Centers Physician-directed Regenerative Cellular Therapies Fountain Life operates 4 longevity centers. July 2025
Ophthalmic Product Companies Exclusive Sublicense/Contract Manufacturing Celularity\'s in-kind investment in DefEYE\'s funding round was $12MM. October 2025
Future Patients (Degenerative Diseases) Cellular Therapies (e.g., PDA-002) Phase 2 Clinical Trial Results Publication. October 14, 2025

Celularity Inc. (CELU) - Canvas Business Model: Cost Structure

You're looking at the core expenses that drive Celularity Inc.'s operations as of late 2025, especially after that major balance sheet cleanup in August.

High research and development (R&D) expenses remain a significant cost. For the full year 2024, R&D spending was reported at $17,386 thousand, which aligns closely with the $17.4 million figure you noted. This spend fuels the development pipeline, including advancing those late-stage cell therapy candidates.

Selling, general, and administrative (SG&A) expenses were also substantial in the prior year. In 2024, SG&A hit $58,450 thousand, or about $58.5 million, which is right near the $58.6 million mark you mentioned. Honestly, this category includes the overhead to support the commercialization of the advanced biomaterial products and the general corporate functions.

Here's a quick look at the major operating expense buckets from the last fully reported annual period, which sets the baseline for your current view:

Expense Category Amount (USD Thousands) - Year Ended 12/31/2024
Research and Development $17,386
Sales, General and Admin $58,450
Total Operating Expenses $92,600

You've got significant manufacturing and quality control costs tied up in cGMP production. Celularity Inc. emphasizes its purpose-built, U.S.-based cGMP compliant facility, aiming to eliminate reliance on contract manufacturing organizations (CMOs). While specific dollar amounts for 2025 manufacturing costs aren't public yet, the infrastructure itself-a 150,000 sq. ft. space with nine Grade C/ISO 7 GMP suites-represents a fixed cost base that supports scalable, inventory-ready product supply.

Costs associated with clinical trials and regulatory filings are inherently lumpy but critical. You saw evidence of this activity continuing into 2025, with the company filing its Form 10-Q quarterly reports for the first and second quarters of 2025, and plans for a 510(k) submission for the FUSE Celularity Bone Void Filler expected in the second half of 2025. These efforts are necessary to expand the commercial portfolio beyond the current advanced biomaterial products.

On the financing side, interest expense has seen a major shift. The company incurred $6,264 thousand in interest expense in 2024. But, the big news is the August 2025 balance sheet restructuring where Celularity Inc. retired all senior secured debt, eliminating $32.0 million in principal and $9.6 million in associated unpaid interest, totaling $41.6 million in debt retirement. That move should significantly reduce future interest expense, freeing up cash flow.

The key cost drivers you need to track going forward are:

  • R&D Spend: Sustaining investment in the cell therapy pipeline.
  • cGMP Operations: Maintaining the specialized, in-house manufacturing infrastructure.
  • Regulatory Milestones: Costs tied to the planned 2025 510(k) submissions.
  • License Payments: New, ongoing quarterly license payments to Celeniv following the IP monetization deal in August 2025.

Finance: draft the projected interest expense reduction for Q4 2025 based on the August debt retirement by next Tuesday.

Celularity Inc. (CELU) - Canvas Business Model: Revenue Streams

You're looking at how Celularity Inc. actually brings in cash, which is key for understanding their path forward. Honestly, for a company in this space, revenue diversification across products, services, and intellectual property is a good sign, even if the absolute numbers are still scaling up.

The revenue streams for Celularity Inc. (CELU) are segmented across product sales, service offerings, and fees from licensing and royalties. Here is a look at the reported figures for the full year 2024, which shows a strong base in product sales.

Revenue Stream Category Amount (USD) Year
Product sales, net, primarily from advanced biomaterials like Biovance® $35.3 million 2024
Services revenue from contract manufacturing and development $5.1 million 2024
License, royalty, and other fees $13.7 million 2024
Total Net Revenue (for comparison) $54.2 million 2024

The total net revenues for Celularity Inc. for the year ended December 31, 2024, were reported as $54.2 million, showing a significant increase of 138.1% compared to the prior year period.

Looking into the more recent performance, the revenue figures for 2025 show the current run rate. You need to watch these quarterly numbers closely to see if the product sales momentum from 2024 is continuing.

Here are the latest reported revenue figures for the 2025 fiscal year:

  • Total revenue for the nine months ended September 30, 2025, was $22.45 million.
  • Revenue for the third quarter (Q3) of 2025 was $5.28 million.

For context, the total net revenue for the nine months ended September 30, 2024, was $36.09 million. The Q3 2025 revenue of $5.28 million compares to $9.3 million reported for Q3 2024.

These revenue streams are supported by the commercial-stage advanced biomaterial offerings, with Biovance® being a key driver of product sales growth.


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