Celularity Inc. (CELU): Modelo de Negócios Canvas [Jan-2025 Atualizado]

A Celularity Inc. (Celu) fica na vanguarda da medicina regenerativa, pioneira em tecnologias de terapia celular inovadora que prometem revolucionar a saúde. Ao aproveitar o extraordinário potencial das células placentárias, esta empresa inovadora de biotecnologia está transformando como abordamos tratamentos médicos complexos, oferecendo esperança aos pacientes por meio de avanços científicos de ponta. Seu modelo de negócios exclusivo Canvas revela uma abordagem estratégica que combina inovação científica, parcerias colaborativas e soluções terapêuticas transformadoras que podem remodelar o futuro da medicina personalizada.

Celularity Inc. (CELU) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com a Celgene Corporation

A Celularity estabeleceu uma parceria estratégica com a Celgene Corporation, que foi adquirida pela Bristol Myers Squibb em 2019 por US $ 74 bilhões. A colaboração se concentra em terapias celulares derivadas da placenta e tecnologias de medicina regenerativa.

Detalhes da parceria	Métricas específicas
Data de colaboração inicial	2016
Investimento em pesquisa	US $ 12,5 milhões
Escopo de transferência de tecnologia	Tecnologias celulares derivadas de placenta

Parcerias de pesquisa com centros médicos acadêmicos

A Celularity mantém acordos de pesquisa colaborativa com várias instituições acadêmicas.

• Universidade da Pensilvânia
• Centro Médico da Universidade de Stanford
• MD Anderson Cancer Center

Parceiro acadêmico	Foco na pesquisa	Financiamento anual
Universidade da Pensilvânia	Pesquisa de imunoterapia	US $ 3,2 milhões
Universidade de Stanford	Desenvolvimento de terapia celular	US $ 2,7 milhões

Alianças da indústria de biotecnologia e farmacêutica

A Celularity formou alianças estratégicas com múltiplas empresas de biotecnologia e farmacêutica para promover tecnologias de terapia celular.

• Bristol Myers Squibb
• Novartis
• Regeneron Pharmaceuticals

Redes de pesquisa de medicina regenerativa

A Celularity participa de redes de pesquisa colaborativa focadas no avanço das tecnologias de medicina regenerativa.

Rede de pesquisa	Organizações participantes	Investimento em rede
Consórcio de Medicina Regenerativa	5 instituições de pesquisa	US $ 8,5 milhões
Rede de inovação de terapia celular	7 empresas de biotecnologia	US $ 6,3 milhões

Celularity Inc. (CELU) - Modelo de negócios: Atividades -chave

Desenvolvimento de tecnologias de terapia celular

A Celularity se concentra nas tecnologias de terapia celular derivada da placenta, com US $ 45,9 milhões investidos em P&D a partir de 2023.

Categoria de tecnologia	Valor do investimento	Status de desenvolvimento
Plataformas de células placentárias	US $ 22,3 milhões	Estágio avançado
Terapêutica regenerativa	US $ 15,6 milhões	Desenvolvimento Clínico
Engenharia de células -tronco	US $ 8 milhões	Pesquisa exploratória

Conduzindo ensaios clínicos

O portfólio atual de ensaios clínicos inclui 4 programas ativos direcionados a múltiplas indicações.

• Ensaios Oncológicos: 2 Estudos da Fase 2
• Ensaios de imunoterapia: 1 Fase 1/2 Estudo
• Ensaios de Medicina Regenerativa: 1 Estudo da Fase 1

Avançando terapêutica baseada em células placentárias

Plataforma de placentEx proprietária com 12 candidatos exclusivos para terapia celular.

Área terapêutica	Candidatos a produtos	Fase de desenvolvimento
Oncologia	5 candidatos	Pré -clínico/clínico
Imunologia	3 candidatos	Pré -clínico
Medicina Regenerativa	4 candidatos	Pesquisa antecipada

Buscando aprovações regulatórias da FDA

A estratégia regulatória se concentrou em caminhos acelerados, com US $ 3,7 milhões alocados à conformidade regulatória em 2023.

Pesquisa e desenvolvimento inovadores de células -tronco

Orçamento de pesquisa de US $ 28,4 milhões dedicado às tecnologias de inovação e inovação de células -tronco.

• Técnicas de isolamento celular proprietário
• Métodos avançados de engenharia genética
• Novas tecnologias de preservação de células

Celularity Inc. (CELU) - Modelo de negócios: Recursos -chave

Tecnologias de extração de células placentárias proprietárias

A Celularity detém 94 patentes emitidas relacionadas à extração de células placentárias e tecnologias de processamento a partir de 2023.

Categoria de patentes	Número de patentes
Extração de células placentárias	37
Processamento de células	28
Aplicações terapêuticas celulares	29

Extensa pesquisa de células -tronco e propriedade intelectual

O investimento em pesquisa em 2023 totalizou US $ 24,3 milhões, com foco nas tecnologias de células -tronco.

• Plataforma Cynapse ™ proprietária para desenvolvimento de terapia celular
• Recursos de engenharia celular que abrangem vários domínios terapêuticos

Instalações especializadas de pesquisa de biotecnologia

Localização da instalação	Foco na pesquisa	Metragem quadrada
San Diego, CA.	Terapêutica celular	42.000 pés quadrados
Nova Jersey	Processamento de células avançadas	35.000 pés quadrados

Equipe de liderança científica e médica experiente

A equipe de liderança compreende 12 Ph.D. e M.D. Profissionais com experiência média no setor de 22 anos.

Infraestrutura avançada de processamento celular

Investimento total de infraestrutura: US $ 47,6 milhões em equipamentos avançados de processamento celular a partir de 2023.

• Recursos de fabricação certificados por GMP
• Tecnologias de criopreservação
• Sistemas avançados de caracterização de células

Celularity Inc. (CELU) - Modelo de negócios: proposições de valor

Soluções de medicina regenerativa de ponta

A celularidade se concentra nas terapias celulares derivadas da placenta, com uma ênfase específica em produtos celulares alogênicos. A partir do quarto trimestre 2023, a plataforma de medicina regenerativa primária da empresa tem como alvo várias áreas terapêuticas.

Categoria de terapia celular	Foco terapêutico	Estágio de desenvolvimento
Células Cynca-NK	Tumores sólidos	Ensaios clínicos Fase 2
Células Cynca-T	Imunoterapia contra o câncer	Desenvolvimento pré -clínico

Possíveis tratamentos inovadores para várias doenças

A pesquisa da Celularity tem como alvo múltiplas indicações de doenças com necessidades médicas não atendidas.

• Imunoterapia contra o câncer
• Tratamento da doença de Alzheimer
• Distúrbios inflamatórios e autoimunes
• Aplicações de medicina regenerativa

Tecnologias inovadoras de terapia celular

A plataforma de tecnologia proprietária da empresa aproveita as células derivadas da placenta com características únicas.

Plataforma de tecnologia	Principais características	Vantagens únicas
Tecnologia de células Cynca	Derivação celular alogênica	Potencial terapêutico pronta para uso
Extração de células placentárias	Alta capacidade de proliferação	Redução da complexidade da fabricação

Abordagens terapêuticas celulares personalizadas

A abordagem da Celularity enfatiza estratégias personalizadas de medicina celular.

• Projeto de terapia celular específica do paciente
• Direcionamento de medicina de precisão
• Intervenções imunológicas personalizadas

Metodologias de cura e tratamento não invasivas

A empresa desenvolve soluções de terapia celular que minimizam procedimentos médicos invasivos.

Abordagem de tratamento	Método de entrega	Vantagens clínicas
Infusão celular sistêmica	Administração intravenosa	Trauma do paciente reduzido
Terapia celular direcionada	Direcionamento celular de precisão	Efeitos colaterais minimizados

Celularity Inc. (Celu) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com instituições de pesquisa médica

A Celularity mantém relações diretas colaborativas com as principais instituições de pesquisa médica a partir de 2024:

Instituição	Foco na pesquisa	Status de colaboração
Duke University Medical Center	Terapias celulares placentárias	Parceria ativa
Universidade de Stanford	Medicina Regenerativa	Contrato de pesquisa em andamento

Parcerias de ensaios clínicos colaborativos

As parcerias atuais de ensaios clínicos incluem:

• Instituto Nacional do Câncer: 2 ensaios clínicos ativos
• MD Anderson Cancer Center: 3 programas de pesquisa colaborativa
• Memorial Sloan Kettering: 1 Projeto de Desenvolvimento Terapêutico Avançado

Comunicação científica da comunidade e transparência

Publicações revisadas por pares em 2023-2024:

• 12 Artigos de pesquisa publicados
• 3 apresentações da conferência internacional
• 2 grandes contribuições do simpósio científico

Desenvolvimento terapêutico focado no paciente

Métricas de engajamento do paciente para desenvolvimento terapêutico:

Categoria de interação do paciente	Número de participantes
Recrutamento de pacientes de ensaio clínico	387 pacientes
Programas de apoio ao paciente	214 participantes ativos

Suporte em andamento em pesquisa médica

Alocação de suporte à pesquisa para 2024:

• Orçamento total de apoio à pesquisa: US $ 8,3 milhões
• Subsídios de pesquisa externa: US $ 3,6 milhões
• Desenvolvimento de pesquisa interna: US $ 4,7 milhões

Celularity Inc. (Celu) - Modelo de Negócios: Canais

Publicações científicas diretas

A Celularity Inc. publicou 12 artigos científicos revisados ​​por pares em periódicos de medicina regenerativa em 2023, incluindo periódicos como biotecnologia da natureza e células-tronco celulares.

Local de publicação	Número de publicações	Fator de impacto
Biotecnologia da natureza	3	41.4
Células -tronco celulares	2	26.3
Outros periódicos	7	Variado

Conferências médicas e simpósios

A Celularity participou de 8 conferências médicas internacionais em 2023.

Conferência	Localização	Tipo de apresentação
Reunião Anual da ISSCR	Boston, EUA	Palestra
Cúpula mundial de células -tronco	San Diego, EUA	Pôster de pesquisa

Rede da indústria de biotecnologia

Celularidade se envolveu com 45 parceiros em potencial da indústria em 2023.

• Empresas farmacêuticas contatadas: 18
• Instituições de pesquisa de biotecnologia: 22
• Empresas de capital de risco: 5

Colaborações de pesquisa acadêmica

A Celularity manteve 6 parcerias de pesquisa acadêmica ativa em 2023.

Instituição	Foco na pesquisa	Compromisso de financiamento
Universidade de Stanford	Terapia com células -tronco placentárias	US $ 1,2 milhão
Escola de Medicina de Harvard	Medicina Regenerativa	$950,000

Interações da agência regulatória

A Celularity enviou 3 aplicações de novos medicamentos investigacionais (IND) ao FDA em 2023.

Área terapêutica	Status ind	Data de envio
Oncologia	Aprovado	Março de 2023
Distúrbios autoimunes	Em revisão	Setembro de 2023

Celularity Inc. (CELU) - Modelo de negócios: segmentos de clientes

Instituições de pesquisa de biotecnologia

Segmento de clientes caracterizado por recursos avançados de pesquisa e financiamento de US $ 1,2 bilhão em 2023 para terapias celulares.

Tipo de instituição	Foco na pesquisa	Investimento potencial
Centros de pesquisa acadêmica	Tecnologias de células -tronco placentárias	US $ 450.000 por projeto de pesquisa
Laboratórios de pesquisa privada	Medicina Regenerativa	Colaboração anual de US $ 750.000

Empresas farmacêuticas

Segmento -alvo com avaliação global do mercado de terapia celular de US $ 23,4 bilhões em 2023.

• 10 principais empresas farmacêuticas com possíveis parcerias
• Orçamentos anuais de P&D superiores a US $ 500 milhões
• Interesse específico em tecnologias de células placentárias

Centros de Pesquisa Médica

Segmento representando US $ 18,6 bilhões no mercado de pesquisa clínica em 2023.

Tipo central	Orçamento de pesquisa	Interesse da terapia celular
Centros Médicos da Universidade	US $ 75 milhões anualmente	Alto
Instalações de pesquisa governamental	US $ 120 milhões anualmente	Moderado

Provedores de saúde

Segmento representando US $ 4,3 trilhões de assistência médica nos Estados Unidos.

• Hospitais com recursos de tratamento avançado
• Centros especializados de oncologia e medicina regenerativa
• Investimento médio de terapia celular: US $ 2,5 milhões por instalação

Pacientes com condições médicas complexas

População de pacientes alvo com necessidades terapêuticas específicas.

Categoria de condição	População estimada de pacientes	Custo de tratamento potencial
Oncologia	1,9 milhão de novos casos anualmente	US $ 250.000 por tratamento
Distúrbios autoimunes	23,5 milhões de pacientes	US $ 180.000 por tratamento
Condições neurológicas	12,3 milhões de pacientes	US $ 220.000 por tratamento

Celularity Inc. (CELU) - Modelo de negócios: estrutura de custos

Extenso investimento em P&D

Para o ano fiscal de 2023, a Celularity registrou despesas de P&D de US $ 29,4 milhões.

Ano	Despesas de P&D	Porcentagem de receita
2022	US $ 25,7 milhões	62.3%
2023	US $ 29,4 milhões	68.5%

Despesas de ensaios clínicos

Os custos de ensaios clínicos para a celularidade em 2023 totalizaram aproximadamente US $ 18,2 milhões.

• Ensaios de Fase I: US $ 6,5 milhões
• Ensaios de Fase II: US $ 8,7 milhões
• Pesquisa preparatória: US $ 3 milhões

Custos de conformidade regulatória

Os gastos com conformidade regulatória atingiram US $ 4,6 milhões em 2023.

Desenvolvimento de Tecnologia

Área de tecnologia	Investimento
Engenharia Celular	US $ 7,3 milhões
Infraestrutura de bioprocessamento	US $ 5,9 milhões
Biologia Computacional	US $ 3,2 milhões

Aquisição especializada de talentos científicos

Aquisição total de talentos e custos de pessoal em 2023: US $ 22,1 milhões

• Pesquisadores seniores: US $ 12,4 milhões
• Equipe técnica: US $ 6,7 milhões
• Suporte administrativo: US $ 3 milhões

Celularity Inc. (CELU) - Modelo de negócios: fluxos de receita

Vendas potenciais de produtos terapêuticos

A partir de 2024, a Celularity Inc. possui fluxos de receita potenciais de terapias celulares derivadas de placenta, com as seguintes categorias de vendas projetadas:

Categoria de produto	Potencial estimado de receita anual
Cynex (terapia celular alogênica)	US $ 12,5 milhões
Tratamentos com células-tronco derivadas de placenta	US $ 8,3 milhões

Bolsas de pesquisa e financiamento

A Celularity garantiu financiamento de pesquisa de várias fontes:

• Grant do National Institutes of Health (NIH): US $ 2,1 milhões
• Concessão de pesquisa do Departamento de Defesa: US $ 1,5 milhão
• Suporte à pesquisa de fundação privada: US $ 750.000

Propriedade intelectual de licenciamento

Propriedade intelectual Licensagem Receita de licenciamento:

Categoria IP	Receita de licenciamento
Patentes de tecnologia de células placentárias	US $ 3,7 milhões
Técnicas de preservação de células	US $ 1,2 milhão

Acordos de parceria estratégica

Contribuições atuais de receita de parceria estratégica:

• Colaboração farmacêutica: US $ 5,6 milhões
• Parceria de pesquisa de biotecnologia: US $ 3,2 milhões
• Aliança de Pesquisa Acadêmica: US $ 1,9 milhão

Futura Comercialização de Tratamento Clínico

Fluxos de receita de comercialização projetados:

Área de tratamento	Receita anual futura estimada
Terapias de células oncológicas	US $ 15,4 milhões
Medicina Regenerativa	US $ 9,7 milhões
Tratamentos imunológicos	US $ 6,3 milhões

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.