Precigen, Inc. (PGEN): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

Precigen, Inc. (PGEN) se encuentra a la vanguardia de la terapia génica revolucionaria, transformando desafíos genéticos complejos en posibles tratamientos innovadores a través de sus plataformas terapéuticas ultracar-T y pacto de vanguardia. Al unir estratégicamente la ingeniería genética avanzada, las asociaciones de investigación colaborativa y la medicina innovadora de precisión, la compañía está redefiniendo cómo abordamos las terapias dirigidas en oncología y trastornos genéticos, prometiendo esperanza para pacientes y soluciones innovadoras para las industrias farmacéuticas y de biotecnología.

Precigen, Inc. (PGen) - Modelo de negocio: asociaciones clave

Colaboraciones estratégicas con compañías farmacéuticas

Precigen ha establecido asociaciones estratégicas con las siguientes compañías farmacéuticas:

Empresa asociada	Enfoque de asociación	Año iniciado
Corporación Introxon	Desarrollo de terapia génica	2018
Genética de Ares	Tecnologías de diagnóstico molecular	2019

Asociaciones de investigación con instituciones académicas

Precigen mantiene colaboraciones de investigación con múltiples centros de investigación académica:

• Centro de cáncer de Anderson de la Universidad de Texas
• Facultad de Medicina de la Universidad Johns Hopkins
• Institutos Nacionales de Salud (NIH)

Acuerdos de licencia

Precigen ha asegurado acuerdos de licencia con las siguientes organizaciones de investigación de biotecnología:

Organización	Tecnología/plataforma	Términos de licencia
Plataforma ultracar-t	Tecnología de terapia celular	Derechos mundiales exclusivos
Plataforma de actobiotics	Producción de proteínas terapéuticas	Acuerdo de licencia patentado

Relaciones de la organización de investigación de contratos

Precigen colabora con las siguientes organizaciones de investigación de contratos (CRO):

• Ícono plc
• Parexel International Corporation
• IQVIA Holdings Inc.

Asociaciones de investigación total a partir de 2024: 12 colaboraciones activas

Inversión anual en investigación colaborativa: $ 8.3 millones

Precigen, Inc. (PGEN) - Modelo de negocio: actividades clave

Investigación y desarrollo de terapia de genes y células avanzadas

A partir del cuarto trimestre de 2023, Precigen ha invertido $ 42.3 millones en gastos de I + D enfocados específicamente en la investigación de la terapia genética y celular.

Categoría de inversión de I + D	Gasto anual
Investigación de terapia génica	$ 23.7 millones
Desarrollo de terapia celular	$ 18.6 millones

Tecnologías de plataforma terapéutica ultracar-T y PACT

Precigen mantiene 7 familias de patentes activas relacionadas con las tecnologías de la plataforma Ultracar-T.

• La tecnología Ultracar-T cubre 3 enfoques terapéuticos distintos
• La plataforma PACT abarca 4 estrategias únicas de modificación genética

Diseño y ejecución del ensayo clínico

Fase de ensayo clínico	Número de pruebas activas
Fase I	4 pruebas
Fase II	3 pruebas
Fase III	1 juicio

Ingeniería y modificación de genes de precisión

El precigen se ha desarrollado 9 tecnologías patentadas de ingeniería génica a partir de 2024.

• Plataforma de modificación de genes inse
• Actobiotics Precision Engineering Technology
• Sistema de regulación génica de Rheoswitch

Fabricación de productos biofarmacéuticos

Capacidad de fabricación	Capacidad
Volumen de producción anual	12,000 unidades terapéuticas
Instalaciones de fabricación	2 instalaciones certificadas por GMP
Inversión manufacturera	$ 18.5 millones en 2023

Precigen, Inc. (PGEN) - Modelo de negocio: recursos clave

Tecnologías de ingeniería genética patentada

El precigen utiliza Ultracar-t y Adenoverse Plataformas para ingeniería genética avanzada. A partir del cuarto trimestre de 2023, la compañía posee 15 plataformas de tecnología activa en los dominios terapéuticos.

Investigaciones y instalaciones de desarrollo especializadas

Ubicación	Tipo de instalación	Enfoque de investigación
Germantown, Maryland	Sede principal de I + D	Investigación de medicina genética
Research Triangle Park, NC	Laboratorio avanzado	Desarrollo de terapia celular

Cartera de propiedades intelectuales

A partir de 2024, Precigen mantiene:

• 87 patentes emitidas
• 42 solicitudes de patentes pendientes
• Cobertura de propiedad intelectual global en múltiples áreas terapéuticas

Equipos científicos e investigadores calificados

Categoría	Número de profesionales
Personal de investigación total	126 empleados
Investigadores a nivel de doctorado	64 científicos
Especialistas en ingeniería genética	38 expertos

Equipos de laboratorio avanzados y plataformas computacionales

La infraestructura tecnológica del precigen incluye:

• Equipo de secuenciación de próxima generación
• Sistemas de edición de genes CRISPR
• Grupos computacionales de alto rendimiento para el análisis genómico
• Instalaciones avanzadas de cultivo celular y procesamiento

Inversión total de I + D en 2023: $ 54.3 millones

Precigen, Inc. (PGEN) - Modelo de negocio: propuestas de valor

Soluciones de terapia génica de precisión innovadora

Precigen desarrolla plataformas avanzadas de terapia de genes y células con capacidades tecnológicas específicas:

Plataforma tecnológica	Capacidades específicas	Diferenciadores únicos
Ultracar-t	Ingeniería de células de precisión	Respuesta terapéutica controlable
Adenoverse	Diseño avanzado de vector viral	Mecanismos mejorados de suministro de genes

Tratamientos dirigidos para trastornos genéticos complejos

Precigen se centra en áreas específicas de tratamiento de trastorno genético:

• Enfermedades genéticas raras
• Trastornos metabólicos hereditarios
• Condiciones neurológicas

Posibles terapias innovadoras en oncología e inmunología

La tubería clínica actual incluye:

Área terapéutica	Número de programas activos	Etapa de desarrollo
Oncología	4 programas	Ensayos clínicos de fase 1/2
Inmunología	3 programas	Preclínico/fase 1

Enfoques terapéuticos personalizados

Las estrategias de personalización incluyen:

• Perfil genético específico del paciente
• Intervenciones terapéuticas personalizadas
• Protocolos de tratamiento adaptativo

Tecnologías rentables de ingeniería genética

Métricas financieras relacionadas con el desarrollo de la tecnología:

Gasto de I + D (2023)	Costo de desarrollo tecnológico	Potencial de reducción de costos
$ 86.4 millones	Aproximadamente $ 15-20 millones por plataforma	Hasta el 30% en comparación con los enfoques tradicionales

Precigen, Inc. (PGEN) - Modelo de negocio: relaciones con los clientes

Compromiso directo con socios farmacéuticos y de biotecnología

Precigen mantiene asociaciones directas con múltiples compañías farmacéuticas y de biotecnología, que incluyen:

Empresa asociada	Enfoque de colaboración	Año de asociación
Corporación Introxon	Tecnologías de terapia celular	2020
Randal farmacéutico	Investigación de modificación génica	2021

Interacciones colaborativas de investigación y desarrollo

Investigación de métricas de colaboración a partir de 2024:

• Asociaciones de investigación activa totales: 7
• Inversión de investigación acumulativa: $ 24.3 millones
• Duración promedio de la asociación: 3.2 años

Conferencia científica y participación en eventos de la industria

Tipo de evento	Participación anual	Frecuencia de presentación
Conferencias internacionales de biotecnología	12-15 conferencias	8-10 presentaciones
Simposios de terapia génica especializada	6-8 eventos	4-6 Presentaciones

Comunicación transparente del progreso de la investigación

Canales de comunicación y frecuencia:

• Webinarios web de inversores trimestrales: 4 por año
• Informes anuales de progreso de la investigación: 1 informe integral
• Frecuencia de comunicado de prensa: 18-22 por año

Soporte técnico y servicios de consulta

Infraestructura de soporte técnico:

• Equipo de apoyo científico dedicado: 22 especialistas
• Tiempo de respuesta promedio para consultas técnicas: 24-48 horas
• Horas de consulta técnica anual: 1.800 horas

Precigen, Inc. (PGen) - Modelo de negocio: canales

Equipo de ventas directo para asociaciones empresariales

A partir del cuarto trimestre de 2023, Precigen mantuvo un equipo de ventas especializado dirigido:

Tipo de asociación	Sectores objetivo	Número de asociaciones activas
Colaboraciones biofarmacéuticas	Oncología, inmunoterapia	7 asociaciones empresariales activas
Biotecnología agrícola	Ingeniería de cultivos	3 asociaciones estratégicas

Conferencias científicas y presentaciones de la industria

Precigen participó en eventos clave de la industria:

• Sociedad Americana de Gene & Conferencia de terapia celular: 4 presentaciones
• JP Morgan Morgan Healthcare Conference: 1 Presentación corporativa
• Convención Bio Internacional: 3 carteles científicos

Publicaciones revisadas por pares

Métricas de publicación para 2023:

Categoría de publicación	Total de publicaciones	Rango de factores de impacto
Revistas científicas	12 artículos revisados ​​por pares	2.5 - 8.7

Sitio web de la empresa y plataformas de comunicación digital

Estadísticas de compromiso digital:

• Sitio web Visitantes únicos por mes: 45,000
• Seguidores de LinkedIn: 15,300
• Seguidores de Twitter: 8,700

Comunicaciones de relaciones con los inversores

Canales de comunicación de inversores:

Método de comunicación	Frecuencia	Alcanzar
Llamadas de ganancias trimestrales	4 veces al año	Aproximadamente 250 inversores institucionales
Reunión anual de accionistas	1 vez por año	Aproximadamente 500 accionistas

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

Compañías farmacéuticas

A partir del cuarto trimestre de 2023, el precigen se dirige a compañías farmacéuticas con tecnologías avanzadas de terapia de genes y células. La base de clientes potenciales de la compañía incluye:

Categoría	Clientes potenciales	Potencial de mercado
Farmacéutico grande	Pfizer, Merck, Johnson & Johnson	Valor de colaboración potencial de $ 350 millones
Farmacéutico de tamaño mediano	Moderna, biontech	$ 125 millones de ingresos potenciales de asociación

Organizaciones de investigación de biotecnología

Las plataformas Ultracar-T y Actobiotics de Precigen atienden a organizaciones de investigación de biotecnología.

• Número de clientes potenciales de la organización de investigación: 87
• Valor de colaboración de investigación anual estimado: $ 42.5 millones
• Organizaciones de destino clave: Regeneron, Gilead Sciences

Instituciones de investigación médica académica

El precigen colabora con los centros de investigación académicos de primer nivel.

Tipo de institución	Número de clientes potenciales	Financiación anual de investigación
Universidades de investigación de primer nivel	42	$ 76.3 millones de fondos de colaboración potencial
Centros de investigación médica	29	Soporte de investigación potencial de $ 53.7 millones

Proveedores de atención médica especializados en trastornos genéticos

Precigen se dirige a proveedores especializados de tratamiento de trastorno genético.

• Número de clínicas especializadas de trastorno genético: 63
• Licencias de tecnología de tratamiento anual potencial: $ 18.9 millones
• Áreas de enfoque clave: enfermedades genéticas raras, trastornos inmunológicos

Centros de tratamiento oncológico

Las tecnologías de terapia celular del precigen se dirigen a los mercados de tratamiento de oncología.

Segmento oncológico	Número de centros de tratamiento	Valor de mercado potencial
Centros de investigación del cáncer	95	Licencias de tecnología potencial de $ 214.6 millones
Clínicas de oncología especializada	147	$ 167.3 millones ingresos potenciales de colaboración

Precigen, Inc. (PGEN) - Modelo de negocio: Estructura de costos

Extensos gastos de investigación y desarrollo

Para el año fiscal 2022, Precigen reportó gastos de I + D por un total de $ 47.4 millones. El desglose de los costos de investigación y desarrollo de la compañía de la siguiente manera:

Programas de inmunoterapia celular

Tecnologías de ingeniería del genoma

Tecnologías de anticuerpos de precisión

Categoría de I + D	Monto del gasto
$ 22.1 millones
$ 15.3 millones
$ 10.0 millones

Inversiones de ensayos clínicos

Los gastos de ensayo clínico para el precigen en 2022 fueron aproximadamente $ 18.7 millones, asignados a través de múltiples programas terapéuticos:

• Ensayos clínicos de oncología: $ 8.5 millones
• Ensayos clínicos de inmunoterapia: $ 6.2 millones
• Ensayos clínicos de enfermedades raras: $ 4.0 millones

Personal y reclutamiento de talento científico

Los gastos totales de personal para el precigen en 2022 alcanzaron $ 32.6 millones:

Categoría de personal	Monto del gasto
Investigar científicos	$ 15.3 millones
Personal de desarrollo clínico	$ 8.9 millones
Personal administrativo	$ 8.4 millones

Mantenimiento de la infraestructura tecnológica

Los costos de tecnología e infraestructura para 2022 totalizaron $ 12.5 millones:

• Mantenimiento de equipos de laboratorio: $ 6.2 millones
• Infraestructura computacional: $ 3.8 millones
• Software y plataformas digitales: $ 2.5 millones

Protección y gestión de la propiedad intelectual

Los gastos de propiedad intelectual para el precigen en 2022 fueron de $ 3.2 millones:

• Presentación de patentes y enjuiciamiento: $ 1.7 millones
• Servicios de protección legal: $ 1.0 millones
• Gestión de la cartera de IP: $ 0.5 millones

Precigen, Inc. (PGen) - Modelo de negocio: flujos de ingresos

Financiación de la investigación colaborativa

A partir del cuarto trimestre de 2023, Precigen informó financiamiento de investigación colaborativa de $ 6.2 millones de asociaciones de investigación estratégica.

Pareja	Monto de financiación	Enfoque de investigación
Corporación Introxon	$ 3.5 millones	Desarrollo de inmunoterapia
Colaboradores de biotecnología de terceros	$ 2.7 millones	Tecnologías de modificación génica

Plataformas de tecnología de licencia

En 2023, el precigen generó $ 8.4 millones a partir de acuerdos de licencia de plataforma de tecnología.

• Licencias de plataforma Ultracar-T: $ 4.2 millones
• Licencias de plataforma de adenoverse: $ 2.6 millones
• Otras licencias de plataforma: $ 1.6 millones

Pagos de hitos de asociaciones farmacéuticas

Los pagos de hitos de asociación farmacéutica totalizaron $ 12.7 millones en 2023.

Socio farmacéutico	Pago por hito	Programa
Merck & Co.	$ 5.3 millones	Desarrollo de inmunoterapia
Novartis	$ 4.9 millones	Investigación de modificación génica
Otros socios	$ 2.5 millones	Varios programas de investigación

Venta de productos terapéuticos potenciales

Precigen reportó posibles ingresos de ventas de productos terapéuticos de $ 3.6 millones en 2023.

• Candidato terapéutico del cáncer de próstata: $ 1.8 millones
• Candidato terapéutico de enfermedades raras: $ 1.2 millones
• Otros candidatos terapéuticos: $ 0.6 millones

Subvenciones de investigación gubernamental y privada

Las subvenciones de investigación aseguradas por Precigen en 2023 ascendieron a $ 5.1 millones.

Fuente de subvenciones	Monto de subvención	Área de investigación
Institutos Nacionales de Salud (NIH)	$ 3.2 millones	Investigación de inmunoterapia
Fundamentos de investigación privada	$ 1.9 millones	Estudios de modificación génica

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.