Celularity Inc. (CELU): Business Model Canvas [Jan-2025 Mise à jour]

Celularity Inc. (CELU) est à l'avant-garde de la médecine régénérative, des technologies de thérapie cellulaire révolutionnaire pionnières qui promettent de révolutionner les soins de santé. En exploitant le potentiel extraordinaire des cellules placentaires, cette entreprise innovante de biotechnologie transforme la façon dont nous abordons les traitements médicaux complexes, offrant de l'espoir aux patients à travers des percées scientifiques de pointe. Leur toile de modèle commercial unique révèle une approche stratégique qui combine l'innovation scientifique, les partenariats collaboratifs et les solutions thérapeutiques transformatrices qui pourraient remodeler l'avenir de la médecine personnalisée.

Celularity Inc. (CELU) - Modèle commercial: partenariats clés

Collaboration stratégique avec Celgene Corporation

Celularité a établi un partenariat stratégique avec Celgene Corporation, qui a été acquis par Bristol Myers Squibb en 2019 pour 74 milliards de dollars. La collaboration se concentre sur les thérapies cellulaires dérivées des placentaires et les technologies de médecine régénérative.

Détails du partenariat	Métriques spécifiques
Date de collaboration initiale	2016
Investissement en recherche	12,5 millions de dollars
Portée de transfert de technologie	Technologies cellulaires dérivées de placentaires

Partenariats de recherche avec des centres médicaux académiques

Celularité maintient des accords de recherche collaboratifs avec plusieurs établissements universitaires.

• Université de Pennsylvanie
• Centre médical de l'Université de Stanford
• MD Anderson Cancer Center

Partenaire académique	Focus de recherche	Financement annuel
Université de Pennsylvanie	Recherche d'immunothérapie	3,2 millions de dollars
Université de Stanford	Développement de la thérapie cellulaire	2,7 millions de dollars

Biotechnologie et alliances de l'industrie pharmaceutique

La célularité a formé des alliances stratégiques avec de multiples sociétés de biotechnologie et pharmaceutiques pour faire progresser les technologies de thérapie cellulaire.

• Bristol Myers Squibb
• Novartis
• Regeneron Pharmaceuticals

Réseaux de recherche en médecine régénérative

La Celularité participe à des réseaux de recherche collaboratifs axés sur la progression des technologies de médecine régénérative.

Réseau de recherche	Organisations participantes	Investissement en réseau
Consortium de médecine régénérative	5 institutions de recherche	8,5 millions de dollars
Réseau d'innovation de thérapie cellulaire	7 entreprises de biotechnologie	6,3 millions de dollars

Celularity Inc. (CELU) - Modèle d'entreprise: activités clés

Développer des technologies de thérapie cellulaire

Celularité se concentre sur les technologies de thérapie cellulaire dérivées des placentaires avec 45,9 millions de dollars investis dans la R&D en 2023.

Catégorie de technologie	Montant d'investissement	Statut de développement
Plates-formes de cellules placentaires	22,3 millions de dollars	Étape avancée
Thérapeutique régénérative	15,6 millions de dollars	Développement clinique
Ingénierie des cellules souches	8 millions de dollars	Recherche exploratoire

Effectuer des essais cliniques

Le portefeuille actuel des essais cliniques comprend 4 programmes actifs ciblant plusieurs indications.

• Essais en oncologie: 2 études de phase 2
• Essais d'immunothérapie: 1 phase 1/2 étude
• Essais de médecine régénérative: 1 étude de phase 1

Avançant des thérapies à base de cellules placentaires

Plate-forme de placentex propriétaire avec 12 candidats de produits de thérapie cellulaire unique.

Zone thérapeutique	Produits candidats	Phase de développement
Oncologie	5 candidats	Préclinique / clinique
Immunologie	3 candidats	Préclinique
Médecine régénérative	4 candidats	RECHERCHE PROBLÈME

Poursuivre les approbations réglementaires de la FDA

La stratégie réglementaire s'est concentrée sur les voies accélérées avec 3,7 millions de dollars alloués à la conformité réglementaire en 2023.

Recherche et développement des cellules souches innovantes

Budget de recherche de 28,4 millions de dollars dédié aux technologies d'innovation et de percée des cellules souches.

• Techniques d'isolement des cellules propriétaires
• Méthodes de génie génétique avancées
• Nouvelles technologies de préservation cellulaire

Celularity Inc. (CELU) - Modèle d'entreprise: Ressources clés

Technologies d'extraction des cellules placentaires propriétaires

La célularité détient 94 brevets émis liés aux technologies d'extraction et de traitement des cellules placentaires en 2023.

Catégorie de brevet	Nombre de brevets
Extraction des cellules placentaires	37
Traitement des cellules	28
Applications thérapeutiques cellulaires	29

Recherche approfondie des cellules souches et propriété intellectuelle

L'investissement en recherche en 2023 a totalisé 24,3 millions de dollars, en se concentrant sur les technologies de cellules souches.

• Plateforme propriétaire Cynapse ™ pour le développement de la thérapie cellulaire
• Capacités d'ingénierie cellulaire couvrant plusieurs domaines thérapeutiques

Installations de recherche spécialisée en biotechnologie

Emplacement de l'installation	Focus de recherche	En pieds carrés
San Diego, CA	Thérapeutique cellulaire	42 000 pieds carrés
New Jersey	Traitement des cellules avancées	35 000 pieds carrés

Équipe expérimentée de leadership scientifique et médical

L'équipe de leadership comprend 12 doctorats. et des professionnels de M.D. avec une expérience moyenne de l'industrie de 22 ans.

Infrastructure de traitement cellulaire avancée

Investissement total des infrastructures: 47,6 millions de dollars en équipement de traitement cellulaire avancé à partir de 2023.

• Capacités de fabrication certifiées BPF
• Technologies de cryoconservation
• Systèmes de caractérisation des cellules avancées

Celularity Inc. (CELU) - Modèle d'entreprise: propositions de valeur

Solutions de médecine régénérative de pointe

Celularité se concentre sur les thérapies cellulaires dérivées des placentaires, avec un accent spécifique sur les produits cellulaires allogéniques. Depuis le quatrième trimestre 2023, la principale plate-forme de médecine régénérative de la société cible plusieurs zones thérapeutiques.

Catégorie de thérapie cellulaire	Focus thérapeutique	Étape de développement
Cellules Cynca-NK	Tumeurs solides	Essais cliniques Phase 2
Cellules Cynca-T	Immunothérapie contre le cancer	Développement préclinique

Traitements de percée potentielles pour diverses maladies

La recherche de Celularity cible plusieurs indications de maladie avec des besoins médicaux non satisfaits.

• Immunothérapie contre le cancer
• Traitement de la maladie d'Alzheimer
• Troubles inflammatoires et auto-immunes
• Applications de médecine régénérative

Technologies de thérapie cellulaire innovantes

La plate-forme technologique propriétaire de l'entreprise exploite les cellules dérivées de placentaires avec des caractéristiques uniques.

Plate-forme technologique	Caractéristiques clés	Avantages uniques
Technologie des cellules Cynca	Dérivation des cellules allogéniques	Potentiel thérapeutique standard
Extraction des cellules placentaires	Capacité de prolifération élevée	Complexité de fabrication réduite

Approches thérapeutiques cellulaires personnalisées

L'approche de la Celularité met l'accent sur les stratégies de médecine cellulaire personnalisées.

• Conception de thérapie cellulaire spécifique au patient
• Médecine de précision ciblant
• Interventions immunologiques personnalisées

Méthodologies de guérison et de traitement non invasives

L'entreprise développe des solutions de thérapie cellulaire qui minimisent les procédures médicales invasives.

Approche de traitement	Méthode de livraison	Avantages cliniques
Perfusion de cellules systémiques	Administration intraveineuse	Réduction des traumatismes du patient
Thérapie cellulaire ciblée	Ciblage cellulaire de précision	Effets secondaires minimisés

Celularity Inc. (CELU) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les institutions de recherche médicale

Celularité entretient des relations collaboratives directes avec les principales institutions de recherche médicale à partir de 2024:

Institution	Focus de recherche	Statut de collaboration
Duke University Medical Center	Thérapies cellulaires placentaires	Partenariat actif
Université de Stanford	Médecine régénérative	Accord de recherche en cours

Partenariats collaboratifs d'essais cliniques

Les partenariats actuels des essais cliniques comprennent:

• Institut national du cancer: 2 essais cliniques actifs
• MD Anderson Cancer Center: 3 programmes de recherche collaborative
• Memorial Sloan Kettering: 1 projet de développement thérapeutique avancé

Communication et transparence de la communauté scientifique

Publications évaluées par des pairs en 2023-2024:

• 12 articles de recherche publiés
• 3 présentations de la conférence internationale
• 2 contributions majeures au symposium scientifique

Développement thérapeutique axé sur les patients

Métriques d'engagement des patients pour le développement thérapeutique:

Catégorie d'interaction des patients	Nombre de participants
Recrutement des patients en essai clinique	387 patients
Programmes de soutien aux patients	214 participants actifs

Soutien de la recherche médicale en cours

L'allocation de soutien à la recherche pour 2024:

• Budget total de soutien à la recherche: 8,3 millions de dollars
• Subventions de recherche externe: 3,6 millions de dollars
• Développement de la recherche interne: 4,7 millions de dollars

Celularity Inc. (CELU) - Modèle d'entreprise: canaux

Publications scientifiques directes

Celularity Inc. a publié 12 articles scientifiques évalués par des pairs dans des revues de médecine régénérative en 2023, y compris des revues telles que la biotechnologie de la nature et les cellules souches cellulaires.

Lieu de publication	Nombre de publications	Facteur d'impact
Biotechnologie de la nature	3	41.4
Cellule souche	2	26.3
Autres revues	7	Varié

Conférences médicales et symposiums

Celularité a participé à 8 conférences médicales internationales en 2023.

Conférence	Emplacement	Type de présentation
Assemblée annuelle ISSCR	Boston, États-Unis	Couverture
Sommet mondial des cellules souches	San Diego, États-Unis	Affiche de recherche

Réseautage de l'industrie de la biotechnologie

Celularité s'est engagée avec 45 partenaires potentiels de l'industrie en 2023.

• Les sociétés pharmaceutiques contactées: 18
• Institutions de recherche en biotechnologie: 22
• Sociétés de capital-risque: 5

Collaborations de recherche universitaire

Celularité a maintenu 6 partenariats de recherche académique actifs en 2023.

Institution	Focus de recherche	Engagement de financement
Université de Stanford	Thérapie de cellules souches placentaires	1,2 million de dollars
École de médecine de Harvard	Médecine régénérative	$950,000

Interactions d'agence de réglementation

Celularité a soumis 3 demandes d'enquête sur les nouveaux médicaments (IND) à la FDA en 2023.

Zone thérapeutique	Statut ind	Date de soumission
Oncologie	Approuvé	Mars 2023
Troubles auto-immunes	En cours d'examen	Septembre 2023

Celularity Inc. (CELU) - Modèle d'entreprise: segments de clientèle

Institutions de recherche en biotechnologie

Segment de clientèle caractérisé par des capacités de recherche avancées et un financement de 1,2 milliard de dollars en 2023 pour les thérapies cellulaires.

Type d'institution	Focus de recherche	Investissement potentiel
Centres de recherche universitaires	Technologies de cellules souches placentaires	450 000 $ par projet de recherche
Laboratoires de recherche privés	Médecine régénérative	Collaboration annuelle de 750 000 $

Sociétés pharmaceutiques

Segment cible avec évaluation du marché mondial de la thérapie cellulaire de 23,4 milliards de dollars en 2023.

• Top 10 des sociétés pharmaceutiques avec des partenariats potentiels
• Budgets de R&D annuels dépassant 500 millions de dollars
• Intérêt spécifique pour les technologies de cellules placentaires

Centres de recherche médicale

Segment représentant 18,6 milliards de dollars sur le marché de la recherche clinique en 2023.

Type de centre	Budget de recherche	Intérêt de thérapie cellulaire
Centres médicaux universitaires	75 millions de dollars par an	Haut
Installations de recherche gouvernementales	120 millions de dollars par an	Modéré

Fournisseurs de soins de santé

Segment représentant 4,3 billions de dollars sur le marché des soins de santé aux États-Unis.

• Hôpitaux avec des capacités de traitement avancées
• Centres spécialisés en oncologie et en médecine régénérative
• Investissement moyen de thérapie cellulaire: 2,5 millions de dollars par établissement

Patients souffrant de conditions médicales complexes

Cible la population de patients avec des besoins thérapeutiques spécifiques.

Catégorie d'état	Population estimée des patients	Coût potentiel de traitement
Oncologie	1,9 million de nouveaux cas par an	250 000 $ par traitement
Troubles auto-immunes	23,5 millions de patients	180 000 $ par traitement
Conditions neurologiques	12,3 millions de patients	220 000 $ par traitement

Celularity Inc. (CELU) - Modèle d'entreprise: Structure des coûts

Investissement étendu de R&D

Pour l'exercice 2023, la Celularité a déclaré des frais de R&D de 29,4 millions de dollars.

Année	Dépenses de R&D	Pourcentage de revenus
2022	25,7 millions de dollars	62.3%
2023	29,4 millions de dollars	68.5%

Dépenses des essais cliniques

Les coûts des essais cliniques pour la célularité en 2023 ont totalisé environ 18,2 millions de dollars.

• Essais de phase I: 6,5 millions de dollars
• Essais de phase II: 8,7 millions de dollars
• Recherche préparatoire: 3 millions de dollars

Coûts de conformité réglementaire

Les dépenses de conformité réglementaire ont atteint 4,6 millions de dollars en 2023.

Développement technologique

Zone technologique	Investissement
Génie cellulaire	7,3 millions de dollars
Infrastructure de bioprocédés	5,9 millions de dollars
Biologie informatique	3,2 millions de dollars

Acquisition spécialisée de talents scientifiques

Acquisition totale des talents et coûts du personnel en 2023: 22,1 millions de dollars

• Chercheurs seniors: 12,4 millions de dollars
• Personnel technique: 6,7 millions de dollars
• Support administratif: 3 millions de dollars

Celularity Inc. (CELU) - Modèle d'entreprise: Strots de revenus

Ventes de produits thérapeutiques potentiels

En 2024, Celularity Inc. a des sources de revenus potentielles des thérapies cellulaires dérivées des placentaires, avec les catégories de ventes projetées suivantes:

Catégorie de produits	Potentiel des revenus annuels estimés
Cynex (thérapie cellulaire allogénique)	12,5 millions de dollars
Traitements des cellules souches dérivées des placentaires	8,3 millions de dollars

Subventions et financement de recherche

Celularité a obtenu un financement de recherche à partir de plusieurs sources:

• GRANTION NATIONNELLE DE LA SANTÉ DE SANTÉ (NIH): 2,1 millions de dollars
• Subvention de recherche du ministère de la Défense: 1,5 million de dollars
• Support de recherche sur la fondation privée: 750 000 $

Licence de propriété intellectuelle

Répartition des revenus de licence de propriété intellectuelle:

Catégorie IP	Revenus de licence
Brevets de technologie des cellules placentaires	3,7 millions de dollars
Techniques de préservation des cellules	1,2 million de dollars

Accords de partenariat stratégique

Contributions de revenus de partenariat stratégique actuels:

• Collaboration pharmaceutique: 5,6 millions de dollars
• Biotechnology Research Partnership: 3,2 millions de dollars
• Alliance de recherche universitaire: 1,9 million de dollars

Future commercialisation du traitement clinique

Suites de revenus de commercialisation projetés:

Zone de traitement	Revenus annuels futurs estimés
Thérapies cellulaires en oncologie	15,4 millions de dollars
Médecine régénérative	9,7 millions de dollars
Traitements immunologiques	6,3 millions de dollars

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.