Precigen, Inc. (PGEN): Business Model Canvas [Jan-2025 Mise à jour]

Precigen, Inc. (PGEN) est à l'avant-garde de la thérapie génique révolutionnaire, transformant des défis génétiques complexes en traitements percés potentiels à travers ses plates-formes thérapeutiques ultracar-T et pactes de pointe. En pontant stratégiquement le génie génétique avancé, les partenariats de recherche collaborative et la médecine de précision innovante, la société redéfinit la façon dont nous abordons les thérapies ciblées en oncologie et troubles génétiques, prometteur l'espoir pour les patients et les solutions révolutionnaires pour les industries pharmaceutique et biotechnologique.

Precigen, Inc. (PGEN) - Modèle commercial: partenariats clés

Collaborations stratégiques avec les sociétés pharmaceutiques

La précision a établi des partenariats stratégiques avec les sociétés pharmaceutiques suivantes:

Entreprise partenaire	Focus de partenariat	Année initiée
Intrexon Corporation	Développement de la thérapie génique	2018
Génétique Ares	Technologies diagnostiques moléculaires	2019

Partenariats de recherche avec les établissements universitaires

La précision maintient des collaborations de recherche avec de multiples centres de recherche universitaires:

• Université du Texas MD Anderson Cancer Center
• École de médecine de l'Université Johns Hopkins
• National Institutes of Health (NIH)

Accords de licence

La précipité a obtenu des accords de licence avec les organisations de recherche en biotechnologie suivantes:

Organisation	Technologie / plate-forme	Conditions de licence
Plate-forme Ultracar-T	Technologie de thérapie cellulaire	Droits mondiaux exclusifs
Plate-forme active	Production de protéines thérapeutiques	Accord de licence propriétaire

Relations d'organisation de la recherche contractuelle

La précision collabore avec les organisations de recherche contractuelle suivantes (CRO):

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

Partenariats de recherche totaux à partir de 2024: 12 collaborations actives

Investissement annuel dans la recherche collaborative: 8,3 millions de dollars

Precigen, Inc. (PGEN) - Modèle d'entreprise: activités clés

Recherche et développement de thérapie des gènes et cellulaires avancés

Depuis le quatrième trimestre 2023, la Pricine a investi 42,3 millions de dollars dans les dépenses de R&D spécifiquement axées sur la recherche sur les gènes et la thérapie cellulaire.

Catégorie d'investissement de R&D	Dépenses annuelles
Recherche sur la thérapie génique	23,7 millions de dollars
Développement de la thérapie cellulaire	18,6 millions de dollars

Technologies de plate-forme thérapeutique ultracar-T et Pacte propriétaires

La précision maintient 7 familles de brevets actives liées aux technologies de plate-forme Ultracar-T.

• La technologie Ultracar-T couvre 3 approches thérapeutiques distinctes
• La plate-forme PACT englobe 4 stratégies de modification génétique uniques

Conception et exécution des essais cliniques

Phase d'essai clinique	Nombre d'essais actifs
Phase I	4 essais
Phase II	3 essais
Phase III	1 essai

Ingénierie et modification des gènes de précision

La précigène s'est développée 9 technologies d'ingénierie des gènes propriétaires En 2024.

• Plate-forme de modification du gène inse
• Actobiotics Precision Engineering Technology
• Système de régulation des gènes Rheoswitch

Fabrication de produits biopharmaceutiques

Capacité de fabrication	Capacité
Volume de production annuel	12 000 unités thérapeutiques
Installations de fabrication	2 installations certifiées GMP
Investissement manufacturier	18,5 millions de dollars en 2023

Precigen, Inc. (PGEN) - Modèle d'entreprise: Ressources clés

Technologies de génie génétique propriétaire

La précigène utilise Ultracar-t et Adéverse Plates-formes de génie génétique avancé. Depuis le quatrième trimestre 2023, la société détient 15 plateformes technologiques actives dans des domaines thérapeutiques.

Installations de recherche et développement spécialisées

Emplacement	Type d'installation	Focus de recherche
Germantown, Maryland	Siège de la R&D primaire	Recherche en médecine génétique
Research Triangle Park, NC	Laboratoire avancé	Développement de la thérapie cellulaire

Portefeuille de propriété intellectuelle

Depuis 2024, la précision maintient:

• 87 brevets délivrés
• 42 demandes de brevet en instance
• Couverture mondiale de la propriété intellectuelle dans plusieurs domaines thérapeutiques

Équipes scientifiques et de recherche qualifiées

Catégorie	Nombre de professionnels
Personnel de recherche total	126 employés
Chercheurs de doctorat	64 scientifiques
Spécialistes du génie génétique	38 experts

Équipement de laboratoire avancé et plateformes de calcul

L'infrastructure technologique de la prénigène comprend:

• Équipement de séquençage de nouvelle génération
• Systèmes d'édition de gènes CRISPR
• Clusters de calcul haute performance pour l'analyse génomique
• Culture cellulaire avancée et installations de traitement

Investissement total de R&D en 2023: 54,3 millions de dollars

Precigen, Inc. (PGEN) - Modèle d'entreprise: propositions de valeur

Solutions de thérapie génique de précision innovante

La précigène développe des plateformes de thérapie génique et cellulaire avancées avec des capacités technologiques spécifiques:

Plate-forme technologique	Capacités spécifiques	Différenciateurs uniques
Ultracar-t	Ingénierie des cellules de précision	Réponse thérapeutique contrôlable
Adéverse	Conception de vecteur viral avancé	Mécanismes de livraison de gènes améliorés

Traitements ciblés pour les troubles génétiques complexes

La précision se concentre sur des zones de traitement des troubles génétiques spécifiques:

• Maladies génétiques rares
• Troubles métaboliques hérités
• Conditions neurologiques

Thérapies révolutionnaires potentielles en oncologie et immunologie

Le pipeline clinique actuel comprend:

Zone thérapeutique	Nombre de programmes actifs	Étape de développement
Oncologie	4 programmes	Essais cliniques de phase 1/2
Immunologie	3 programmes	Préclinique / phase 1

Approches thérapeutiques personnalisées

Les stratégies de personnalisation comprennent:

• Profilage génétique spécifique au patient
• Interventions thérapeutiques personnalisées
• Protocoles de traitement adaptatif

Technologies de génie génétique rentables

Mesures financières liées au développement de la technologie:

Dépenses de R&D (2023)	Coût du développement technologique	Potentiel de réduction des coûts
86,4 millions de dollars	Environ 15-20 millions de dollars par plate-forme	Jusqu'à 30% par rapport aux approches traditionnelles

Precigen, Inc. (PGEN) - Modèle d'entreprise: relations avec les clients

Engagement direct avec des partenaires pharmaceutiques et biotechnologiques

La Pricine maintient des partenariats directs avec plusieurs sociétés pharmaceutiques et biotechnologiques, notamment:

Entreprise partenaire	Focus de la collaboration	Année de partenariat
Intrexon Corporation	Technologies de thérapie cellulaire	2020
Randal Pharmaceutical	Recherche de modification des gènes	2021

Interactions de recherche et développement collaborative

Métriques de collaboration de recherche à partir de 2024:

• Partenariats totaux de recherche active: 7
• Investissement de recherche cumulative: 24,3 millions de dollars
• Durée du partenariat moyen: 3,2 ans

Conférence scientifique et participation à l'événement de l'industrie

Type d'événement	Participation annuelle	Fréquence de présentation
Conférences internationales de biotechnologie	12-15 conférences	8-10 présentations
Symposiums spécialisés de thérapie génique	6-8 événements	4-6 présentations

Communication transparente des progrès de la recherche

Canaux de communication et fréquence:

• Webinaires trimestriels des investisseurs: 4 par an
• Rapports d'avancement de la recherche annuelle: 1 rapport complet
• Fréquence du communiqué de presse: 18-22 par an

Services de support technique et de consultation

Infrastructure de soutien technique:

• Équipe de soutien scientifique dédié: 22 spécialistes
• Temps de réponse moyen pour les demandes techniques: 24-48 heures
• Heures de consultation technique annuelles: 1 800 heures

Precigen, Inc. (PGEN) - Modèle d'entreprise: canaux

Équipe de vente directe pour les partenariats d'entreprise

Au quatrième trimestre 2023, Precigen a maintenu une équipe de vente spécialisée ciblant:

Type de partenariat	Secteurs cibles	Nombre de partenariats actifs
Collaborations biopharmaceutiques	Oncologie, immunothérapie	7 partenariats d'entreprise actifs
Biotechnologie agricole	Génie des cultures	3 partenariats stratégiques

Conférences scientifiques et présentations de l'industrie

La précigène a participé à des événements clés de l'industrie:

• Société américaine de gène & Conférence de thérapie cellulaire: 4 présentations
• Conférence JP Morgan Healthcare: 1 présentation d'entreprise
• Convention internationale bio: 3 affiches scientifiques

Publications évaluées par des pairs

Métriques de publication pour 2023:

Catégorie de publication	Publications totales	Plage du facteur d'impact
Revues scientifiques	12 articles évalués par des pairs	2.5 - 8.7

Site Web de l'entreprise et plateformes de communication numérique

Statistiques de l'engagement numérique:

• Site Web Visiteurs uniques par mois: 45 000
• LinkedIn adepte: 15 300
• Twitter abonnés: 8,700

Communications des relations avec les investisseurs

Canaux de communication des investisseurs:

Méthode de communication	Fréquence	Atteindre
Appels de résultats trimestriels	4 fois par an	Environ 250 investisseurs institutionnels
Réunion des actionnaires annuelle	1 fois par an	Environ 500 actionnaires

Precigen, Inc. (PGEN) - Modèle d'entreprise: segments de clientèle

Sociétés pharmaceutiques

Depuis le quatrième trimestre 2023, la précision cible les sociétés pharmaceutiques avec des technologies avancées de thérapie génique et cellulaire. La clientèle potentielle de l'entreprise comprend:

Catégorie	Clients potentiels	Potentiel de marché
Grand pharmacie	Pfizer, Merck, Johnson & Johnson	Valeur de collaboration potentielle de 350 millions de dollars
Pharma de taille moyenne	Moderne, biontech	125 millions de dollars de revenus de partenariat potentiel

Organisations de recherche en biotechnologie

Les plates-formes Ultracar-T et Actobiotiques de la Pricine servent des organisations de recherche en biotechnologie.

• Nombre de clients d'organisation de recherche potentielle: 87
• Valeur de collaboration de recherche annuelle estimée: 42,5 millions de dollars
• Organisations cibles clés: Regeneron, Gilead Sciences

Établissements de recherche médicale académique

La précision collabore avec des centres de recherche universitaires de haut niveau.

Type d'institution	Nombre de clients potentiels	Financement de la recherche annuelle
Universités de recherche de haut niveau	42	76,3 millions de dollars de financement de collaboration potentielle
Centres de recherche médicale	29	53,7 millions de dollars de soutien à la recherche potentiel

Fournisseurs de soins de santé spécialisés dans les troubles génétiques

La précision cible les prestataires de traitements de troubles génétiques spécialisés.

• Nombre de cliniques spécialisées sur les troubles génétiques: 63
• Licence potentielle de technologie de traitement annuelle: 18,9 millions de dollars
• Domaines d'intervention clés: maladies génétiques rares, troubles immunologiques

Centres de traitement en oncologie

Les technologies de thérapie cellulaire de la précision ciblent les marchés de traitement en oncologie.

Segment d'oncologie	Nombre de centres de traitement	Valeur marchande potentielle
Centres de recherche sur le cancer	95	214,6 millions de dollars de licence de technologie potentielle
Cliniques d'oncologie spécialisées	147	167,3 millions de dollars de revenus de collaboration potentiels

Precigen, Inc. (PGEN) - Modèle d'entreprise: Structure des coûts

Dépenses de recherche et développement approfondies

Pour l'exercice 2022, Precigen a déclaré des dépenses de R&D totalisant 47,4 millions de dollars. La rupture de la recherche et du développement de l'entreprise les coûte comme suit:

Programmes d'immunothérapie cellulaire

Technologies d'ingénierie du génome

Technologies d'anticorps de précision

Catégorie de R&D	Montant des dépenses
22,1 millions de dollars
15,3 millions de dollars
10,0 millions de dollars

Investissements d'essais cliniques

Les dépenses d'essai cliniques pour la précigène en 2022 étaient d'environ 18,7 millions de dollars, allouées dans plusieurs programmes thérapeutiques:

• Essais cliniques en oncologie: 8,5 millions de dollars
• Essais cliniques d'immunothérapie: 6,2 millions de dollars
• Essais cliniques de maladies rares: 4,0 millions de dollars

Recrutement du personnel et des talents scientifiques

Le total des dépenses de personnel pour la précigène en 2022 a atteint 32,6 millions de dollars:

Catégorie de personnel	Montant des dépenses
Chercheur	15,3 millions de dollars
Personnel de développement clinique	8,9 millions de dollars
Personnel administratif	8,4 millions de dollars

Maintenance des infrastructures technologiques

Les coûts de technologie et d'infrastructure pour 2022 ont totalisé 12,5 millions de dollars:

• Entretien de l'équipement de laboratoire: 6,2 millions de dollars
• Infrastructure informatique: 3,8 millions de dollars
• Plateformes logicielles et numériques: 2,5 millions de dollars

Protection et gestion de la propriété intellectuelle

Les dépenses de propriété intellectuelle pour la précision en 2022 étaient de 3,2 millions de dollars:

• Dépôt de brevets et poursuites: 1,7 million de dollars
• Services de protection juridique: 1,0 million de dollars
• Gestion du portefeuille IP: 0,5 million de dollars

Precigen, Inc. (PGEN) - Modèle d'entreprise: Strots de revenus

Financement de recherche collaborative

Au quatrième trimestre 2023, Precigen a signalé un financement de recherche en collaboration de 6,2 millions de dollars dans des partenariats de recherche stratégique.

Partenaire	Montant du financement	Focus de recherche
Intrexon Corporation	3,5 millions de dollars	Développement d'immunothérapie
Collaborateurs de biotechnologie tiers	2,7 millions de dollars	Technologies de modification des gènes

Plateformes technologiques de licence

En 2023, la précision a généré 8,4 millions de dollars à partir des accords de licence de plateforme technologique.

• Licence de plate-forme UltraCar-T: 4,2 millions de dollars
• Licence de plate-forme Adeverse: 2,6 millions de dollars
• Autre licence de plate-forme: 1,6 million de dollars

Payments d'étape provenant des partenariats pharmaceutiques

Les paiements des étapes du partenariat pharmaceutique ont totalisé 12,7 millions de dollars en 2023.

Partenaire pharmaceutique	Paiement d'étape	Programme
Miserrer & Co.	5,3 millions de dollars	Développement d'immunothérapie
Novartis	4,9 millions de dollars	Recherche de modification des gènes
Autres partenaires	2,5 millions de dollars	Divers programmes de recherche

Ventes de produits thérapeutiques potentiels

La précision a déclaré un chiffre d'affaires potentiel de produits thérapeutiques de 3,6 millions de dollars en 2023.

• Candidat thérapeutique au cancer de la prostate: 1,8 million de dollars
• Candidat thérapeutique rare maladie: 1,2 million de dollars
• Autres candidats thérapeutiques: 0,6 million de dollars

Subventions de recherche gouvernementales et privées

Les subventions de recherche obtenues par la précision en 2023 s'élevaient à 5,1 millions de dollars.

Source d'octroi	Montant d'octroi	Domaine de recherche
National Institutes of Health (NIH)	3,2 millions de dollars	Recherche d'immunothérapie
Fondations de recherche privée	1,9 million de dollars	Études de modification des gènes

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.