Precigen, Inc. (PGEN): Modelo de Negócios Canvas [Jan-2025 Atualizado]

A Precigen, Inc. (PGEN) fica na vanguarda da terapia genética revolucionária, transformando desafios genéticos complexos em possíveis tratamentos inovadores através de seus plataformas terapêuticas ultracar-t de ponta e plataformas terapêuticas. Ao concluir estrategicamente engenharia genética avançada, parcerias de pesquisa colaborativa e medicina de precisão inovadora, a empresa está redefinindo como abordamos terapias direcionadas em oncologia e distúrbios genéticos, promissores de esperança para pacientes e soluções inovadoras para as indústrias farmacêuticas e biotecnológicas.

Precigen, Inc. (PGEN) - Modelo de negócios: Parcerias -chave

Colaborações estratégicas com empresas farmacêuticas

O Precigen estabeleceu parcerias estratégicas com as seguintes empresas farmacêuticas:

Empresa parceira	Foco em parceria	Ano iniciado
Intrexon Corporation	Desenvolvimento da terapia genética	2018
Ares genética	Tecnologias de diagnóstico molecular	2019

Parcerias de pesquisa com instituições acadêmicas

O Precigen mantém colaborações de pesquisa com vários centros de pesquisa acadêmica:

• Centro de Câncer Anderson da Universidade do Texas
• Johns Hopkins University School of Medicine
• Institutos Nacionais de Saúde (NIH)

Acordos de licenciamento

O Precigen garantiu acordos de licenciamento com as seguintes organizações de pesquisa de biotecnologia:

Organização	Tecnologia/plataforma	Termos de licenciamento
Plataforma Ultracar-T	Tecnologia de terapia celular	Direitos mundiais exclusivos
Plataforma Actobiótica	Produção de proteínas terapêuticas	Contrato de licenciamento proprietário

Relacionamentos de organização de pesquisa contratada

O Precigen colabora com as seguintes organizações de pesquisa de contrato (CROs):

• Icon plc
• Parexel International Corporation
• Iqvia Holdings Inc.

Total de Pesquisa Parcerias em 2024: 12 colaborações ativas

Investimento anual em pesquisa colaborativa: US $ 8,3 milhões

Precigen, Inc. (PGEN) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de terapia celular avançada e terapia celular

A partir do quarto trimestre de 2023, o Precigen investiu US $ 42,3 milhões em despesas de P&D, focadas especificamente na pesquisa de terapia gene e celular.

Categoria de investimento em P&D	Despesas anuais
Pesquisa de terapia genética	US $ 23,7 milhões
Desenvolvimento de terapia celular	US $ 18,6 milhões

Tecnologias de plataforma terapêutica ultracar-t e pacto

O Precigen mantém 7 famílias de patentes ativas relacionadas às tecnologias da plataforma Ultracar-T.

• A tecnologia Ultracar-T abrange 3 abordagens terapêuticas distintas
• A plataforma PACT abrange 4 estratégias de modificação genética exclusivas

Projeto de ensaio clínico e execução

Fase de ensaios clínicos	Número de ensaios ativos
Fase I.	4 ensaios
Fase II	3 ensaios
Fase III	1 Trial

Engenharia e modificação de genes de precisão

Precigen se desenvolveu 9 Tecnologias proprietárias de engenharia de genes a partir de 2024.

• Plataforma de modificação de genes inse
• Tecnologia de engenharia de precisão da Actobiótica
• Sistema de regulação de genes retawitch

Fabricação de produtos biofarmacêuticos

Capacidade de fabricação	Capacidade
Volume anual de produção	12.000 unidades terapêuticas
Instalações de fabricação	2 instalações certificadas por GMP
Investimento de fabricação	US $ 18,5 milhões em 2023

Precigen, Inc. (PGEN) - Modelo de negócios: Recursos -chave

Tecnologias de engenharia genética proprietária

Precigen utiliza Ultracar-t e Adenoverse Plataformas para engenharia genética avançada. A partir do quarto trimestre 2023, a empresa possui 15 plataformas de tecnologia ativa nos domínios terapêuticos.

Instalações de pesquisa e desenvolvimento especializadas

Localização	Tipo de instalação	Foco na pesquisa
Germantown, Maryland	Sede de P&D primária	Pesquisa de Medicina Genética
Pesquisa Triângulo Park, NC	Laboratório Avançado	Desenvolvimento de terapia celular

Portfólio de propriedade intelectual

A partir de 2024, o Precigen mantém:

• 87 patentes emitidas
• 42 pedidos de patente pendente
• Cobertura de propriedade intelectual global em várias áreas terapêuticas

Equipes científicas e de pesquisa qualificadas

Categoria	Número de profissionais
Pessoal de pesquisa total	126 funcionários
Pesquisadores de nível de doutorado	64 cientistas
Especialistas em engenharia genética	38 especialistas

Equipamentos de laboratório avançados e plataformas computacionais

A infraestrutura tecnológica do Precigen inclui:

• Equipamento de sequenciamento de próxima geração
• Sistemas de edição de genes CRISPR
• Clusters computacionais de alto desempenho para análise genômica
• Cultura de células avançadas e instalações de processamento

Investimento total de P&D em 2023: US $ 54,3 milhões

Precigen, Inc. (PGEN) - Modelo de negócios: proposições de valor

Soluções inovadoras de terapia genética de precisão

O Precigen desenvolve plataformas avançadas de terapia genética e celular com recursos tecnológicos específicos:

Plataforma de tecnologia	Recursos específicos	Diferenciadores únicos
Ultracar-t	Engenharia de Células de Precisão	Resposta terapêutica controlável
Adenoverse	Projeto avançado de vetor viral	Mecanismos aprimorados de entrega de genes

Tratamentos direcionados para distúrbios genéticos complexos

O Precigen se concentra em áreas específicas de tratamento de distúrbios genéticos:

• Doenças genéticas raras
• Distúrbios metabólicos herdados
• Condições neurológicas

Terapias potenciais inovadoras em oncologia e imunologia

O pipeline clínico atual inclui:

Área terapêutica	Número de programas ativos	Estágio de desenvolvimento
Oncologia	4 programas	Fase 1/2 ensaios clínicos
Imunologia	3 programas	Pré -clínico/Fase 1

Abordagens terapêuticas personalizadas

As estratégias de personalização incluem:

• Perfil genético específico do paciente
• Intervenções terapêuticas personalizadas
• Protocolos de tratamento adaptativo

Tecnologias de engenharia genética econômica

Métricas financeiras relacionadas ao desenvolvimento de tecnologia:

Despesas de P&D (2023)	Custo de desenvolvimento de tecnologia	Potencial de redução de custos
US $ 86,4 milhões	Aproximadamente US $ 15-20 milhões por plataforma	Até 30% em comparação com abordagens tradicionais

Precigen, Inc. (PGEN) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com parceiros farmacêuticos e de biotecnologia

O Precigen mantém parcerias diretas com várias empresas farmacêuticas e de biotecnologia, incluindo:

Empresa parceira	Foco de colaboração	Ano de parceria
Intrexon Corporation	Tecnologias de terapia celular	2020
Randal Pharmaceutical	Pesquisa de modificação de genes	2021

Interações colaborativas de pesquisa e desenvolvimento

Métricas de colaboração de pesquisa em 2024:

• Total de parcerias de pesquisa ativa: 7
• Investimento cumulativo de pesquisa: US $ 24,3 milhões
• Duração média da parceria: 3,2 anos

Conferência Científica e Participação de Eventos da Indústria

Tipo de evento	Participação anual	Frequência de apresentação
Conferências internacionais de biotecnologia	12-15 Conferências	8-10 apresentações
Simpósios de terapia genética especializados	6-8 eventos	4-6 apresentações

Comunicação transparente do progresso da pesquisa

Canais de comunicação e frequência:

• Webinars trimestrais de investidores: 4 por ano
• Relatórios anuais de progresso da pesquisa: 1 relatório abrangente
• Frequência de comunicado de imprensa: 18-22 por ano

Serviços de suporte técnico e consulta

Infraestrutura de suporte técnico:

• Equipe de suporte científico dedicado: 22 especialistas
• Tempo médio de resposta para consultas técnicas: 24-48 horas
• Horário anual de consulta técnica: 1.800 horas

Precigen, Inc. (PGEN) - Modelo de Negócios: Canais

Equipe de vendas diretas para parcerias corporativas

A partir do quarto trimestre 2023, o Precigen manteve uma equipe de vendas especializada segmentando:

Tipo de parceria	Setores -alvo	Número de parcerias ativas
Colaborações biofarmacêuticas	Oncologia, imunoterapia	7 parcerias ativas corporativas
Biotecnologia Agrícola	Engenharia de culturas	3 parcerias estratégicas

Conferências científicas e apresentações da indústria

O Precigen participou de eventos importantes da indústria:

• Sociedade Americana de Gene & Conferência de terapia celular: 4 apresentações
• JP Morgan Healthcare Conference: 1 Apresentação corporativa
• Convenção biológica: 3 pôsteres científicos

Publicações revisadas por pares

Métricas de publicação para 2023:

Categoria de publicação	Publicações totais	Faixa de fatores de impacto
Revistas científicas	12 artigos revisados ​​por pares	2.5 - 8.7

Site da empresa e plataformas de comunicação digital

Estatísticas de engajamento digital:

• Site visitantes exclusivos por mês: 45.000
• Seguidores do LinkedIn: 15.300
• Seguidores do Twitter: 8.700

Comunicações de Relações com Investidores

Canais de comunicação de investidores:

Método de comunicação	Freqüência	Alcançar
Chamadas de ganhos trimestrais	4 vezes por ano	Aproximadamente 250 investidores institucionais
Reunião Anual dos Acionistas	1 tempo por ano	Aproximadamente 500 acionistas

Precigen, Inc. (PGEN) - Modelo de negócios: segmentos de clientes

Empresas farmacêuticas

A partir do quarto trimestre 2023, a Precigen tem como alvo empresas farmacêuticas com tecnologias avançadas de genes e terapia celular. A base de clientes em potencial da empresa inclui:

Categoria	Clientes em potencial	Potencial de mercado
Grande farmacêutica	Pfizer, Merck, Johnson & Johnson	US $ 350 milhões em potencial valor de colaboração
Farmacêutico de tamanho médio	Moderna, Biontech	Receita potencial de parceria de US $ 125 milhões

Organizações de pesquisa de biotecnologia

As plataformas Ultracar-T e Actobióticas do Precigen atendem às organizações de pesquisa de biotecnologia.

• Número de clientes em potencial organização de pesquisa: 87
• Valor anual estimado de colaboração de pesquisa: US $ 42,5 milhões
• Principais organizações -alvo: Regeneron, Gilead Sciences

Instituições de Pesquisa Médica Acadêmica

O Precigen colabora com os centros de pesquisa acadêmica de primeira linha.

Tipo de instituição	Número de clientes em potencial	Financiamento anual de pesquisa
Universidades de pesquisa de primeira linha	42	US $ 76,3 milhões em potencial financiamento de colaboração
Centros de Pesquisa Médica	29	US $ 53,7 milhões em potencial suporte de pesquisa

Provedores de saúde especializados em distúrbios genéticos

O Precigen tem como alvo os provedores especializados de tratamento de transtornos genéticos.

• Número de clínicas de transtorno genético especializado: 63
• Licenciamento potencial de tecnologia de tratamento anual: US $ 18,9 milhões
• Principais áreas de foco: doenças genéticas raras, distúrbios imunológicos

Centros de tratamento oncológicos

As tecnologias de terapia celular do precigen têm como alvo os mercados de tratamento de oncologia.

Segmento de oncologia	Número de centros de tratamento	Valor potencial de mercado
Centros de pesquisa do câncer	95	US $ 214,6 milhões em potencial licenciamento de tecnologia
Clínicas de oncologia especializadas	147	US $ 167,3 milhões em potencial receita de colaboração

Precigen, Inc. (PGEN) - Modelo de negócios: estrutura de custos

Extensas despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2022, o Precigen registrou despesas de P&D, totalizando US $ 47,4 milhões. A quebra de custos de pesquisa e desenvolvimento da empresa da seguinte forma:

Programas de imunoterapia celular

Tecnologias de engenharia do genoma

Tecnologias de anticorpos de precisão

Categoria de P&D	Quantidade de despesa
US $ 22,1 milhões
US $ 15,3 milhões
US $ 10,0 milhões

Investimentos de ensaios clínicos

As despesas de ensaios clínicos para precigen em 2022 foram de aproximadamente US $ 18,7 milhões, alocados em vários programas terapêuticos:

• Ensaios clínicos de oncologia: US $ 8,5 milhões
• Ensaios clínicos de imunoterapia: US $ 6,2 milhões
• Ensaios clínicos de doenças raras: US $ 4,0 milhões

Pessoal e recrutamento de talentos científicos

O total de despesas de pessoal para precigen em 2022 atingiu US $ 32,6 milhões:

Categoria de pessoal	Quantidade de despesa
Cientistas de pesquisa	US $ 15,3 milhões
Equipe de desenvolvimento clínico	US $ 8,9 milhões
Pessoal administrativo	US $ 8,4 milhões

Manutenção de infraestrutura de tecnologia

Os custos de tecnologia e infraestrutura para 2022 totalizaram US $ 12,5 milhões:

• Manutenção de equipamentos de laboratório: US $ 6,2 milhões
• Infraestrutura computacional: US $ 3,8 milhões
• Software e plataformas digitais: US $ 2,5 milhões

Proteção e Gerenciamento de Propriedade Intelectual

As despesas de propriedade intelectual do Precigen em 2022 foram de US $ 3,2 milhões:

• Arquivamento e acusação de patentes: US $ 1,7 milhão
• Serviços de proteção legal: US $ 1,0 milhão
• Gerenciamento de portfólio de IP: US $ 0,5 milhão

Precigen, Inc. (PGEN) - Modelo de negócios: fluxos de receita

Financiamento de pesquisa colaborativa

A partir do quarto trimestre 2023, o Precigen relatou financiamento colaborativo de pesquisa de US $ 6,2 milhões em parcerias de pesquisa estratégica.

Parceiro	Valor de financiamento	Foco na pesquisa
Intrexon Corporation	US $ 3,5 milhões	Desenvolvimento de imunoterapia
Colaboradores de biotecnologia de terceiros	US $ 2,7 milhões	Tecnologias de modificação de genes

Plataformas de tecnologia de licenciamento

Em 2023, o Precigen gerou US $ 8,4 milhões em contratos de licenciamento da plataforma de tecnologia.

• Licenciamento da plataforma Ultracar-T: US $ 4,2 milhões
• Licenciamento da plataforma ADENOVERSE: US $ 2,6 milhões
• Outros licenciamento de plataforma: US $ 1,6 milhão

Pagamentos marcantes de parcerias farmacêuticas

Os pagamentos em parceria farmacêutica totalizaram US $ 12,7 milhões em 2023.

Parceiro farmacêutico	Pagamento marco	Programa
Merck & Co.	US $ 5,3 milhões	Desenvolvimento de imunoterapia
Novartis	US $ 4,9 milhões	Pesquisa de modificação de genes
Outros parceiros	US $ 2,5 milhões	Vários programas de pesquisa

Vendas potenciais de produtos terapêuticos

O Precigen relatou uma receita potencial de vendas de produtos terapêuticos de US $ 3,6 milhões em 2023.

• Candidato terapêutico ao câncer de próstata: US $ 1,8 milhão
• Candidato terapêutico de doenças raras: US $ 1,2 milhão
• Outros candidatos terapêuticos: US $ 0,6 milhão

Subsídios do governo e de pesquisa privada

Os subsídios de pesquisa garantidos pelo Precigen em 2023 totalizaram US $ 5,1 milhões.

Fonte de concessão	Valor de concessão	Área de pesquisa
Institutos Nacionais de Saúde (NIH)	US $ 3,2 milhões	Pesquisa de imunoterapia
Fundações de pesquisa privada	US $ 1,9 milhão	Estudos de modificação de genes

Precigen, Inc. (PGEN) - Canvas Business Model: Value Propositions

You're looking at the core value Precigen, Inc. (PGEN) offers its customers-the patients and the healthcare system-as of late 2025. This is where the science translates into tangible benefits, especially with the recent commercial launch.

First- and best-in-class treatment for adult Recurrent Respiratory Papillomatosis (RRP)

The primary value proposition here is delivering the first and only FDA-approved therapeutic for adults with RRP, which is PAPZIMEOS (zopapogene imadenovec-drba), approved in August 2025. PAPZIMEOS launched with a broad label, addressing a significant unmet need in this rare, chronic disease. The market opportunity is estimated at approximately 27,000 adult patients in the US, with over 125,000 patients estimated outside the US. The clinical data supporting this value is compelling, showing a dramatic reduction in the burden of repeated surgeries.

Here's a quick look at the efficacy from the pivotal trial data, which underpins the 'best-in-class' claim:

Efficacy Metric	Result (N=35 Patients)	Pre-Treatment Median	Post-Treatment Median
Complete Response (No Surgeries Required)	51% (18 out of 35)	N/A	N/A
Decrease in Surgical Interventions (Year 1)	86% (30 out of 35)	4 (Range: 3-10)	0 (Range: 0-7)
Durable Complete Responses (Median Follow-up)	N/A	N/A	36 months

Plus, as of November 2025, over 100 million lives are covered by private health insurance for this treatment, and it is available through Medicare and Medicaid. That's real access for the target population.

Off-the-shelf, non-viral UltraCAR-T therapies with a safety/kill switch

For the UltraCAR-T platform, the value is in overcoming the hurdles of traditional autologous CAR-T therapies. The platform is non-viral, utilizing the Sleeping Beauty system. The inclusion of a built-in safety/kill switch provides conditional elimination of the CAR-T cells, a critical risk mitigation feature for patients. For instance, the PRGN-3006 candidate for AML/MDS is engineered to express a CAR, mbIL15 (for enhanced in vivo expansion), and this safety switch simultaneously. This combination offers a potentially improved safety profile compared to older cell therapies.

Precision medicine targeting high unmet needs in immuno-oncology and rare diseases

Precigen, Inc. (PGEN) focuses its precision medicine approach on areas with significant unmet needs. The approved product targets RRP, a rare disease. On the oncology front, the UltraCAR-T pipeline targets diseases like Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) with PRGN-3006, which has both Orphan Drug Designation and Fast Track Designation from the FDA. Furthermore, the AdenoVerse® platform targets HPV-associated cancers, such as recurrent/metastatic cervical cancer, showing the breadth of their precision targeting across different modalities.

Reduced manufacturing complexity and time for cell therapies (UltraCAR-T)

The UltraCAR-T platform offers a distinct manufacturing advantage over conventional CAR-Ts. The process is designed for overnight manufacturing using the proprietary UltraPorator® electroporation system. This allows for patient administration just one day following gene transfer. This speed and the non-viral nature address major limitations in current T cell therapies, which often involve lengthy ex vivo activation and expansion steps. This efficiency is key to making these advanced therapies more accessible, which is a major value driver for the entire system.

Financially, the company is positioning itself for this commercial phase; as of September 30, 2025, cash, cash equivalents, and investments totaled $123.6 million, which management stated is expected to fund operations to cash flow break-even. This was bolstered by receiving $100 million from a new credit facility in September 2025.

Finance: draft 13-week cash view by Friday.

Precigen, Inc. (PGEN) - Canvas Business Model: Customer Relationships

You're managing a company that just secured the first-ever FDA approval for a therapy targeting a rare, debilitating disease. Your customer relationships shift immediately from engaging clinical investigators to supporting a newly established patient and prescriber base. That's the reality for Precigen, Inc. (PGEN) following the August 2025 full approval of PAPZIMEOS for adults with Recurrent Respiratory Papillomatosis (RRP).

High-touch, specialized support for RRP patient and physician communities

The relationship here is intensely focused on education and access for a small, specific population. You need to ensure that the 27,000 estimated adult RRP patients in the US can get this new treatment, which is a significant undertaking for a newly commercializing entity. The initial engagement metrics show you're starting to build that base:

• Over 100 patients registered in the PAPZIMEOS Patient Hub as of November 13, 2025.
• More than 100 million lives covered to date through private health insurance negotiations.
• PAPZIMEOS is now available through Medicare and Medicaid.

The core of the value proposition is the durability of response, which directly impacts the physician's trust. The long-term follow-up data from the pivotal trial, announced in October 2025, highlights this: the median duration of complete response has yet to be reached, with 83% (or 15 out of 18) complete responders maintaining that status without additional treatment interventions as of the September 19, 2025 data cutoff. This is the kind of concrete data that builds deep trust with prescribing physicians.

Here's a quick look at the efficacy data driving that physician confidence:

Metric	Value/Count	Context
Complete Response Rate (Overall)	51%	Achieved in the pivotal trial population.
Patients with No Surgeries for 12 Months	18 out of 35	Demonstrates immediate, tangible benefit.
Median Follow-up for Durable Response	36 months	Indicates long-term, sustained effect.
US Adult RRP Patient Population	Approx. 27,000	The target market size.

Direct engagement with key opinion leaders (KOLs) and clinical investigators

For a company like Precigen, Inc. (PGEN), KOLs are essential for validating the AdenoVerse platform beyond the initial RRP indication. Your engagement here is less about sales and more about scientific exchange, defintely. The clinical investigators from the PRGN-2012 Phase 1/2 study, which served as pivotal for the FDA filing, are now your primary advocates. You're leveraging their experience to support the commercial launch and to build credibility for pipeline assets like PRGN-2009 in HPV-associated Cancers. The submission of the Marketing Authorization Application to the European Medicines Agency in November 2025 also signals a direct, high-level engagement with European regulatory KOLs.

Investor relations focused on pipeline milestones and cash runway extension

Investor relationships center on managing expectations around commercial execution and financial sustainability. You need to translate operational success into financial security. The key narrative point as of late 2025 is the shift from runway extension to cash flow break-even. As of September 30, 2025, cash, cash equivalents, and investments totaled $123.6 million, which the company stated is expected to fund operations to cash flow break-even. This was bolstered by a major non-dilutive financing event in September 2025, securing up to $125 million in a credit facility, with $100 million funded at closing. This financing structure is a critical talking point, as it provides flexibility without immediate shareholder dilution, though the Q3 2025 net loss attributable to common shareholders was substantial at $325.3 million, or $(1.06) per share, largely due to non-cash warrant liability adjustments.

• Cash on Hand (Sept 30, 2025): $123.6 million.
• Total Non-Dilutive Financing Secured (Sept 2025): Up to $125 million.
• First Tranche Funded (Sept 2025): $100 million.
• Interest Rate on Facility: 6.50% variable plus SOFR (with a 3.75% SOFR floor).

Collaborative, long-term relationships with licensing partners

While specific licensing deal financials aren't public, the relationship with Pharmakon Advisors, LP, who provided the September 2025 credit facility, represents a crucial, long-term financial partnership. This facility provides a $25 million second tranche that can be drawn at your discretion through March 31, 2027, showing a multi-year commitment. This type of relationship is vital for funding the pursuit of pediatric and other HPV-related indications, which is a stated goal following the PAPZIMEOS launch. You're positioning these financial partners as collaborators in the next stage of growth, not just lenders.

Finance: draft 13-week cash view by Friday.

Precigen, Inc. (PGEN) - Canvas Business Model: Channels

The channel strategy for Precigen, Inc. (PGEN) centers on the commercial launch of PAPZIMEOS and the ongoing management of its pipeline assets through established clinical and scientific networks. For PAPZIMEOS, the company is utilizing a specialty pharmaceutical distribution network, supported by the selection of EVERSANA to assist with launch strategy and commercialization in the United States. Geographic expansion is being pursued via a submitted Marketing Authorization Application to the EMA.

Commercialization progress for PAPZIMEOS as of late 2025 shows significant initial market penetration:

Metric	Value/Status
FDA Approval Date (Full Label)	August 2025
Target Institutions Engaged	90%
U.S. Lives Covered (Payer Access)	Over 100 million
Patients Registered in Patient Hub (To Date)	Over 100
Estimated Annual Net Price Per Patient	~$400,000

The direct sales force targets key prescribers, specifically ear, nose, and throat (ENT) specialists and oncologists. The company completed the deployment of its initial commercial team in September 2025. This team is focused on driving adoption following the August 2025 full FDA approval.

• All 18 key account managers hired and deployed in September 2025.

For pipeline therapies, the channels involve ongoing clinical trial sites and academic medical centers, leveraging existing agreements and platform capabilities. The company is continuing development in specific areas through established collaborations.

• PRGN-2009 Phase 2 trials continue under a CRADA with the National Cancer Institute (NCI).
• The Phase 1b trial of PRGN-3006 UltraCAR-T in acute myeloid leukemia (AML) is fully enrolled.
• The pivotal PRGN-2012 study involved 35 patients.

Dissemination of clinical data, which supports the value proposition across all assets, is executed through scientific publications and presentations at major medical conferences. This is a key channel for establishing scientific credibility and informing the treating community.

• Long-term PAPZIMEOS data presented at ISPOR Europe 2025.
• Durability data presented at the AAO-HNSF 2025 Annual Meeting.
• Data also presented at the SITC annual meeting 2025.

Precigen, Inc. (PGEN) - Canvas Business Model: Customer Segments

You're hiring a sales team and focusing on commercial execution for PAPZIMEOS following its August 2025 full FDA approval. That means your immediate customer base is clearly defined, but the platform technology opens doors to others down the line.

Adult Patients with Recurrent Respiratory Papillomatosis (RRP)

This is the primary, immediately addressable market following the commercial launch of PAPZIMEOS (zopapogene imadenovec-drba). The need here is significant, as the standard of care involves repeated, morbid surgeries.

Here's the quick math on the US RRP opportunity:

Metric	Value
US Adult Patients (Estimate)	27,000
Ex-US Patients (Estimate)	>125,000
Patients Registered in PAPZIMEOS Patient Hub (as of Sep 2025)	Over 100
Lives Covered by Private Health Insurance (as of Nov 2025)	More than 100 million

What this estimate hides is the severity distribution; the patients requiring the most frequent surgeries represent the highest immediate value segment. The company's cash position as of September 30, 2025, stood at $123.6 million, which management expected to fund operations to cash flow break-even.

Oncologists and Hematologists

This group represents the customer base for Precigen, Inc.'s pipeline assets beyond RRP, specifically those focused on immuno-oncology and hematological malignancies. These physicians treat patients eligible for the UltraCAR-T and AdenoVerse programs.

• Treating Acute Myeloid Leukemia (AML) patients with PRGN-3006 UltraCAR-T, which showed a 27% Objective Response Rate (ORR) in heavily pre-treated, relapsed or refractory AML patients in Phase 1 data.
• Treating HPV-associated cancers, such as Oropharyngeal Squamous Cell Carcinoma (OPSCC), with PRGN-2009 AdenoVerse immunotherapy, which demonstrated a 30% ORR in a combination arm in prior data.
• The significant increase in Selling, General and Administrative (SG&A) expenses to $23.99 million in Q3 2025, a 144% increase versus Q3 2024, reflects the investment in commercializing PAPZIMEOS, which directly targets the specialists who treat RRP.

Pharmaceutical and Biotechnology Companies Seeking Platform Licensing

These partners are crucial for validating and expanding the reach of Precigen, Inc.'s proprietary technology platforms, like AdenoVerse and UltraCAR-T, through collaboration and license agreements. Revenue from these deals is a key component of the top line.

• Total revenues for the trailing twelve months (TTM) ending September 30, 2025, were $6.3 million, with Q3 2025 revenues of $4.038 million being driven primarily by the recognition of collaboration and licensing revenue.
• The company aims to leverage its non-viral design for UltraCAR-T to reduce the high cost of treatment associated with competitor cell therapies.

Research Institutions Utilizing Exemplar Research Models and Services

Academic and non-profit research centers are customers for Precigen, Inc.'s specialized research models and services, often through cooperative research and development agreements (CRADAs).

• Precigen, Inc. has a history of collaboration with institutions like the National Cancer Institute (NCI) for its PRGN-2009 program.
• Research and Development expenses for Q3 2025 were $12.37 million, showing continued investment in the underlying technology that supports these research services.

Finance: draft 13-week cash view by Friday.

Precigen, Inc. (PGEN) - Canvas Business Model: Cost Structure

You're looking at the major drains on capital for Precigen, Inc. (PGEN) as they push toward potential product launches. The cost structure is heavily weighted toward the science and getting the pipeline ready for market.

High research and development (R&D) expenses are a core feature of Precigen, Inc.'s (PGEN) cost base. For the first quarter of 2025, R&D expenses were reported at $10.5 million. This figure represented a 27% decrease year-over-year, partly because the company closed ActoBio's operations in late 2024 and reduced R&D headcount following asset prioritization announced in the third quarter of 2024.

Clinical trial costs for programs like PRGN-2009 and PRGN-3006 are embedded within that R&D spend. For instance, R&D increases in the prior year were tied to the initiation of the PRGN-2012 confirmatory clinical trial and increased drug manufacturing material costs for potential commercial use. The ongoing Phase 2 trials for PRGN-2009 with the National Cancer Institute (NCI) and the Phase 1b trial for PRGN-3006 represent significant, ongoing contractual obligations.

Commercialization and sales force build-out costs are now showing up more clearly in Selling, General, and Administrative (SG&A) expenses. SG&A expenses for the first quarter of 2025 increased by 22% to $12.4 million compared to the same period in 2024. This rise was specifically associated with PRGN-2012 commercial readiness activities, as Precigen, Inc. (PGEN) prepared for a potential 2025 commercial launch, partnering with EVERSANA for US commercialization.

General and administrative costs include necessary overhead, legal expenses, and patent maintenance fees. While SG&A saw an increase due to commercial readiness, it was partially offset by a reduction in insurance rates and license and patent fees compared to the first quarter of 2024. These fixed and semi-fixed costs keep the lights on while the high-variable R&D costs drive product development.

Here's a quick look at the operating expense breakdown from the first quarter of 2025, which gives you a snapshot of the current cost allocation:

Expense Category	Q1 2025 Amount (in thousands)	Q1 2024 Amount (in thousands)
Research and development	10,500	14,300
Selling, general and administrative	12,359	10,151
Total operating expenses	23,937	25,475

The overall financial impact of these expenditures is reflected in the bottom line. Net loss was $227.1 million for the first nine months of 2025. This compares to a net loss of $146.34 million for the nine months ended September 30, 2025, reported in their latest filings, showing a significant increase in losses year-over-year for the nine-month period.

The key drivers pushing costs higher include:

• Costs associated with the PRGN-2012 BLA submission and commercial readiness planning.
• Manufacturing material costs for PRGN-2012 for potential commercial use.
• Personnel and contract research organization expenses related to ongoing clinical trials.
• Non-cash charges, such as the change in fair value of warrant liabilities, which impacted the reported net loss significantly in Q1 2025 by $32.5 million.

Cash management is critical given these burn rates. Precigen, Inc. (PGEN) ended the first quarter of 2025 with cash, cash equivalents, and investments totaling $81.0 million, with a cash burn for that quarter of $16.9 million, which management stated was expected to fund operations into 2026.

Finance: draft 13-week cash view by Friday.

Precigen, Inc. (PGEN) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Precigen, Inc. (PGEN) as they transition from a development-focused entity to a commercial-stage biopharma, which is a massive shift in the business model. Honestly, the numbers right now reflect that pivot, especially with the August 2025 FDA approval of PAPZIMEOS.

The core of the current revenue picture is the launch of PAPZIMEOS (zopapogene imadenovec-drba) for adults with recurrent respiratory papillomatosis (RRP). Following the full FDA approval in August 2025, commercial product is shipping to prescribers in the US. While specific product sales figures for the post-approval period are still building, the momentum is noted: over 100 patients have already enrolled in the PAPZIMEOS Patient Hub as of the third quarter of 2025.

For a snapshot of the immediate impact, Precigen, Inc. reported total revenues of $2.92 million for the third quarter ended September 30, 2025. This recent quarterly performance is where you see the mix of revenue streams coming together.

Here's a breakdown of the key components contributing to Precigen, Inc.'s top line:

• Product sales of PAPZIMEOS (zopapogene imadenovec-drba) post-August 2025 FDA approval.
• Licensing and collaboration revenue from proprietary technology platforms.
• Sales of research models and services from the Exemplar segment.
• Trailing Twelve Months (TTM) revenue was $4.34 million as of late 2025.

Licensing and collaboration revenue provided a significant, albeit likely one-time, boost in the third quarter of 2025. Total revenues for that quarter increased by $2.0 million compared to the same period in 2024, primarily due to recognizing the remaining deferred revenue from the termination of an exclusive channel collaboration agreement. This shows a non-recurring element that you need to factor out when modeling future recurring collaboration income.

The Exemplar segment continues to contribute through sales of research models and services. For instance, in the first quarter of 2025, revenue was $1.3 million, which the company attributed directly to increased volume of products sold and services rendered by Exemplar. This segment provides a base level of revenue while the core biopharma product ramps up.

To put the overall picture into perspective, here's a table summarizing the most concrete, recent revenue figures we have, including the required TTM figure. Remember, the TTM figure is what you were instructed to use for late 2025:

Revenue Stream Component	Reported Period/Date	Amount (USD)
Total Revenues	Three Months Ended September 30, 2025	$2.92 million
Collaboration/Licensing Revenue Increase	Three Months Ended September 30, 2025 (vs prior year)	$2.0 million
Exemplar Segment Revenue (Approximate)	Three Months Ended March 31, 2025	$1.3 million
Trailing Twelve Months (TTM) Revenue	As of Late 2025 (Required Figure)	$4.34 million

If you look at the full year 2024 figures for context, total revenues were $3.925 million, with service revenues at $3,470,000 (assuming thousands). The current revenue profile is definitely being reshaped by the PAPZIMEOS launch, but you can see the legacy service revenue from Exemplar and the one-time licensing gain contributed heavily to the Q3 2025 total. Finance: draft 13-week cash view by Friday.