Precigen, Inc. (PGEN): Business Model Canvas

Precigen, Inc. (PGEN) steht an der Spitze der revolutionären Gentherapie und verwandelt mithilfe seiner hochmodernen Therapieplattformen UltraCAR-T und PACT komplexe genetische Herausforderungen in potenziell bahnbrechende Behandlungen. Durch die strategische Verbindung fortschrittlicher Gentechnik, kooperativer Forschungspartnerschaften und innovativer Präzisionsmedizin definiert das Unternehmen die Art und Weise, wie wir zielgerichtete Therapien in der Onkologie und bei genetischen Störungen angehen, neu und verspricht Hoffnung für Patienten und bahnbrechende Lösungen für die Pharma- und Biotechnologieindustrie.

Precigen, Inc. (PGEN) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Kooperationen mit Pharmaunternehmen

Precigen hat strategische Partnerschaften mit den folgenden Pharmaunternehmen aufgebaut:

Partnerunternehmen	Partnerschaftsfokus	Jahr eingeleitet
Intrexon Corporation	Entwicklung der Gentherapie	2018
Ares-Genetik	Molekulardiagnostische Technologien	2019

Forschungskooperationen mit akademischen Institutionen

Precigen unterhält Forschungskooperationen mit mehreren akademischen Forschungszentren:

• MD Anderson Cancer Center der Universität von Texas
• Medizinische Fakultät der Johns Hopkins University
• National Institutes of Health (NIH)

Lizenzvereinbarungen

Precigen hat Lizenzvereinbarungen mit den folgenden Biotechnologie-Forschungsorganisationen abgeschlossen:

Organisation	Technologie/Plattform	Lizenzbedingungen
UltraCAR-T-Plattform	Zelltherapie-Technologie	Exklusive weltweite Rechte
ActoBiotics-Plattform	Therapeutische Proteinproduktion	Proprietäre Lizenzvereinbarung

Beziehungen zwischen Vertragsforschungsorganisationen

Precigen arbeitet mit den folgenden Auftragsforschungsorganisationen (CROs) zusammen:

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

Gesamtzahl der Forschungspartnerschaften ab 2024: 12 aktive Kooperationen

Jährliche Investition in die Verbundforschung: 8,3 Millionen US-Dollar

Precigen, Inc. (PGEN) – Geschäftsmodell: Hauptaktivitäten

Fortgeschrittene Forschung und Entwicklung im Bereich Gen- und Zelltherapie

Bis zum vierten Quartal 2023 hat Precigen 42,3 Millionen US-Dollar in Forschungs- und Entwicklungskosten investiert, die sich speziell auf die Gen- und Zelltherapieforschung konzentrieren.

Kategorie „F&E-Investitionen“.	Jährliche Ausgaben
Gentherapieforschung	23,7 Millionen US-Dollar
Entwicklung der Zelltherapie	18,6 Millionen US-Dollar

Proprietäre UltraCAR-T- und PACT-Therapieplattformtechnologien

Precigen unterhält sieben aktive Patentfamilien im Zusammenhang mit UltraCAR-T-Plattformtechnologien.

• Die UltraCAR-T-Technologie deckt drei verschiedene Therapieansätze ab
• Die PACT-Plattform umfasst vier einzigartige Strategien zur genetischen Veränderung

Entwurf und Durchführung klinischer Studien

Klinische Studienphase	Anzahl aktiver Versuche
Phase I	4 Versuche
Phase II	3 Versuche
Phase III	1 Versuch

Präzisionsgentechnik und -modifikation

Precigen hat sich entwickelt 9 proprietäre gentechnische Technologien ab 2024.

• INSE-Genmodifikationsplattform
• Präzisionstechnische Technologie von ActoBiotics
• RheoSwitch-Genregulierungssystem

Herstellung biopharmazeutischer Produkte

Fertigungskapazität	Kapazität
Jährliches Produktionsvolumen	12.000 Therapieeinheiten
Produktionsanlagen	2 GMP-zertifizierte Einrichtungen
Fertigungsinvestitionen	18,5 Millionen US-Dollar im Jahr 2023

Precigen, Inc. (PGEN) – Geschäftsmodell: Schlüsselressourcen

Proprietäre gentechnische Technologien

Precigen nutzt UltraCAR-T und AdenoVerse Plattformen für fortgeschrittene Gentechnik. Im vierten Quartal 2023 verfügt das Unternehmen über 15 aktive Technologieplattformen in allen therapeutischen Bereichen.

Spezialisierte Forschungs- und Entwicklungseinrichtungen

Standort	Einrichtungstyp	Forschungsschwerpunkt
Germantown, Maryland	Hauptsitz für Forschung und Entwicklung	Genetische Medizinforschung
Forschung Triangle Park, NC	Fortgeschrittenes Labor	Entwicklung der Zelltherapie

Portfolio für geistiges Eigentum

Ab 2024 behauptet Precigen:

• 87 erteilte Patente
• 42 anhängige Patentanmeldungen
• Weltweite Abdeckung des geistigen Eigentums in mehreren Therapiebereichen

Kompetente Wissenschafts- und Forschungsteams

Kategorie	Anzahl der Fachkräfte
Gesamtes Forschungspersonal	126 Mitarbeiter
Forscher auf Doktorandenniveau	64 Wissenschaftler
Spezialisten für Gentechnik	38 Experten

Fortschrittliche Laborausrüstung und Computerplattformen

Die technologische Infrastruktur von Precigen umfasst:

• Sequenzierungsausrüstung der nächsten Generation
• CRISPR-Geneditierungssysteme
• Hochleistungs-Rechencluster für die Genomanalyse
• Fortschrittliche Zellkultur- und Verarbeitungsanlagen

Gesamtinvestitionen in Forschung und Entwicklung im Jahr 2023: 54,3 Millionen US-Dollar

Precigen, Inc. (PGEN) – Geschäftsmodell: Wertversprechen

Innovative Präzisions-Gentherapielösungen

Precigen entwickelt fortschrittliche Gen- und Zelltherapieplattformen mit spezifischen technologischen Fähigkeiten:

Technologieplattform	Spezifische Fähigkeiten	Einzigartige Unterscheidungsmerkmale
UltraCAR-T	Präzisionszelltechnik	Kontrollierbare therapeutische Reaktion
AdenoVerse	Fortschrittliches virales Vektordesign	Verbesserte Mechanismen zur Genabgabe

Gezielte Behandlung komplexer genetischer Störungen

Precigen konzentriert sich auf bestimmte Behandlungsbereiche genetischer Störungen:

• Seltene genetische Erkrankungen
• Angeborene Stoffwechselstörungen
• Neurologische Erkrankungen

Mögliche bahnbrechende Therapien in der Onkologie und Immunologie

Die aktuelle klinische Pipeline umfasst:

Therapeutischer Bereich	Anzahl aktiver Programme	Entwicklungsphase
Onkologie	4 Programme	Klinische Studien der Phase 1/2
Immunologie	3 Programme	Präklinisch/Phase 1

Personalisierte therapeutische Ansätze

Zu den Personalisierungsstrategien gehören:

• Patientenspezifisches genetisches Profiling
• Maßgeschneiderte therapeutische Interventionen
• Adaptive Behandlungsprotokolle

Kostengünstige gentechnische Technologien

Finanzkennzahlen im Zusammenhang mit der Technologieentwicklung:

F&E-Ausgaben (2023)	Technologieentwicklungskosten	Kostensenkungspotenzial
86,4 Millionen US-Dollar	Ungefähr 15–20 Millionen US-Dollar pro Plattform	Bis zu 30 % im Vergleich zu herkömmlichen Ansätzen

Precigen, Inc. (PGEN) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit Partnern aus der Pharma- und Biotechnologiebranche

Precigen unterhält direkte Partnerschaften mit mehreren Pharma- und Biotechnologieunternehmen, darunter:

Partnerunternehmen	Fokus auf Zusammenarbeit	Jahr der Partnerschaft
Intrexon Corporation	Zelltherapietechnologien	2020
Randal Pharmaceutical	Forschung zur Genveränderung	2021

Kollaborative Forschungs- und Entwicklungsinteraktionen

Kennzahlen zur Forschungszusammenarbeit ab 2024:

• Insgesamt aktive Forschungspartnerschaften: 7
• Kumulierte Forschungsinvestitionen: 24,3 Millionen US-Dollar
• Durchschnittliche Partnerschaftsdauer: 3,2 Jahre

Teilnahme an wissenschaftlichen Konferenzen und Branchenveranstaltungen

Ereignistyp	Jährliche Teilnahme	Häufigkeit der Präsentation
Internationale Biotechnologie-Konferenzen	12-15 Konferenzen	8-10 Vorträge
Spezialisierte Gentherapie-Symposien	6-8 Veranstaltungen	4-6 Vorträge

Transparente Kommunikation des Forschungsfortschritts

Kommunikationskanäle und Häufigkeit:

• Vierteljährliche Investoren-Webinare: 4 pro Jahr
• Jährliche Forschungsfortschrittsberichte: 1 umfassender Bericht
• Häufigkeit der Pressemitteilungen: 18–22 pro Jahr

Technischer Support und Beratungsdienste

Technische Support-Infrastruktur:

• Engagiertes wissenschaftliches Unterstützungsteam: 22 Spezialisten
• Durchschnittliche Antwortzeit für technische Anfragen: 24–48 Stunden
• Jährliche technische Beratungsstunden: 1.800 Stunden

Precigen, Inc. (PGEN) – Geschäftsmodell: Kanäle

Direktvertriebsteam für Unternehmenspartnerschaften

Ab dem vierten Quartal 2023 unterhielt Precigen ein spezialisiertes Vertriebsteam mit folgenden Zielen:

Partnerschaftstyp	Zielsektoren	Anzahl aktiver Partnerschaften
Biopharmazeutische Kooperationen	Onkologie, Immuntherapie	7 aktive Unternehmenspartnerschaften
Agrarbiotechnologie	Pflanzenbau	3 strategische Partnerschaften

Wissenschaftliche Konferenzen und Branchenpräsentationen

Precigen nahm an wichtigen Branchenveranstaltungen teil:

• Amerikanische Gesellschaft für Gene & Zelltherapie-Konferenz: 4 Vorträge
• JP Morgan Healthcare Conference: 1 Unternehmenspräsentation
• BIO International Convention: 3 wissenschaftliche Poster

Von Experten begutachtete Veröffentlichungen

Publikationskennzahlen für 2023:

Publikationskategorie	Gesamtzahl der Veröffentlichungen	Impact-Faktor-Bereich
Wissenschaftliche Zeitschriften	12 von Experten begutachtete Artikel	2.5 - 8.7

Unternehmenswebsite und digitale Kommunikationsplattformen

Statistiken zum digitalen Engagement:

• Einzigartige Website-Besucher pro Monat: 45.000
• LinkedIn-Follower: 15.300
• Twitter-Follower: 8.700

Investor-Relations-Kommunikation

Kommunikationskanäle für Investoren:

Kommunikationsmethode	Häufigkeit	Reichweite
Vierteljährliche Gewinnaufrufe	4 Mal im Jahr	Rund 250 institutionelle Anleger
Jahreshauptversammlung	1 Mal pro Jahr	Etwa 500 Aktionäre

Precigen, Inc. (PGEN) – Geschäftsmodell: Kundensegmente

Pharmaunternehmen

Ab dem vierten Quartal 2023 richtet sich Precigen an Pharmaunternehmen mit fortschrittlichen Gen- und Zelltherapietechnologien. Zum potenziellen Kundenstamm des Unternehmens gehören:

Kategorie	Potenzielle Kunden	Marktpotenzial
Große Pharmaindustrie	Pfizer, Merck, Johnson & Johnson	350 Millionen US-Dollar potenzieller Kooperationswert
Mittelgroße Pharmaindustrie	Moderna, BioNTech	125 Millionen US-Dollar potenzieller Partnerschaftsumsatz

Biotechnologie-Forschungsorganisationen

Die UltraCAR-T- und ActoBiotics-Plattformen von Precigen dienen biotechnologischen Forschungsorganisationen.

• Anzahl potenzieller Kunden von Forschungseinrichtungen: 87
• Geschätzter jährlicher Wert der Forschungskooperation: 42,5 Millionen US-Dollar
• Wichtigste Zielorganisationen: Regeneron, Gilead Sciences

Akademische medizinische Forschungseinrichtungen

Precigen arbeitet mit erstklassigen akademischen Forschungszentren zusammen.

Institutionstyp	Anzahl potenzieller Kunden	Jährliche Forschungsförderung
Erstklassige Forschungsuniversitäten	42	76,3 Millionen US-Dollar potenzielle Kooperationsfinanzierung
Medizinische Forschungszentren	29	53,7 Millionen US-Dollar potenzielle Forschungsunterstützung

Auf genetische Erkrankungen spezialisierte Gesundheitsdienstleister

Precigen richtet sich an spezialisierte Anbieter zur Behandlung genetischer Störungen.

• Anzahl der spezialisierten Kliniken für genetische Störungen: 63
• Mögliche jährliche Lizenzierung für Behandlungstechnologie: 18,9 Millionen US-Dollar
• Schwerpunkte: Seltene genetische Erkrankungen, immunologische Erkrankungen

Onkologische Behandlungszentren

Die Zelltherapietechnologien von Precigen zielen auf die Märkte für onkologische Behandlungen ab.

Segment Onkologie	Anzahl der Behandlungszentren	Potenzieller Marktwert
Krebsforschungszentren	95	Potenzielle Technologielizenzierung im Wert von 214,6 Millionen US-Dollar
Spezialisierte Onkologiekliniken	147	167,3 Millionen US-Dollar potenzieller Kollaborationsumsatz

Precigen, Inc. (PGEN) – Geschäftsmodell: Kostenstruktur

Umfangreiche Forschungs- und Entwicklungsaufwendungen

Für das Geschäftsjahr 2022 meldete Precigen Forschungs- und Entwicklungskosten in Höhe von insgesamt 47,4 Millionen US-Dollar. Die Forschungs- und Entwicklungskosten des Unternehmens verteilen sich wie folgt:

Programme zur zellulären Immuntherapie

Genom-Engineering-Technologien

Präzisions-Antikörpertechnologien

F&E-Kategorie	Ausgabenbetrag
22,1 Millionen US-Dollar
15,3 Millionen US-Dollar
10,0 Millionen US-Dollar

Investitionen in klinische Studien

Die Ausgaben für klinische Studien für Precigen beliefen sich im Jahr 2022 auf etwa 18,7 Millionen US-Dollar und verteilten sich auf mehrere Therapieprogramme:

• Klinische Studien zur Onkologie: 8,5 Millionen US-Dollar
• Klinische Studien zur Immuntherapie: 6,2 Millionen US-Dollar
• Klinische Studien zu seltenen Krankheiten: 4,0 Millionen US-Dollar

Personal- und wissenschaftliche Talentrekrutierung

Die gesamten Personalkosten für Precigen beliefen sich im Jahr 2022 auf 32,6 Millionen US-Dollar:

Personalkategorie	Ausgabenbetrag
Forschungswissenschaftler	15,3 Millionen US-Dollar
Mitarbeiter der klinischen Entwicklung	8,9 Millionen US-Dollar
Verwaltungspersonal	8,4 Millionen US-Dollar

Wartung der Technologieinfrastruktur

Die Technologie- und Infrastrukturkosten für 2022 beliefen sich auf insgesamt 12,5 Millionen US-Dollar:

• Wartung der Laborausrüstung: 6,2 Millionen US-Dollar
• Computerinfrastruktur: 3,8 Millionen US-Dollar
• Software und digitale Plattformen: 2,5 Millionen US-Dollar

Schutz und Verwaltung des geistigen Eigentums

Die Ausgaben für geistiges Eigentum für Precigen beliefen sich im Jahr 2022 auf 3,2 Millionen US-Dollar:

• Patentanmeldung und -verfolgung: 1,7 Millionen US-Dollar
• Rechtsschutzdienste: 1,0 Millionen US-Dollar
• IP-Portfoliomanagement: 0,5 Millionen US-Dollar

Precigen, Inc. (PGEN) – Geschäftsmodell: Einnahmequellen

Verbundforschungsförderung

Im vierten Quartal 2023 meldete Precigen eine gemeinsame Forschungsfinanzierung in Höhe von 6,2 Millionen US-Dollar aus strategischen Forschungspartnerschaften.

Partner	Förderbetrag	Forschungsschwerpunkt
Intrexon Corporation	3,5 Millionen Dollar	Entwicklung der Immuntherapie
Drittpartei-Biotech-Kooperationspartner	2,7 Millionen US-Dollar	Genmodifikationstechnologien

Lizenzierung von Technologieplattformen

Im Jahr 2023 erwirtschaftete Precigen 8,4 Millionen US-Dollar aus Lizenzvereinbarungen für Technologieplattformen.

• Lizenzierung der UltraCAR-T-Plattform: 4,2 Millionen US-Dollar
• Lizenzierung der AdenoVerse-Plattform: 2,6 Millionen US-Dollar
• Andere Plattformlizenzen: 1,6 Millionen US-Dollar

Meilensteinzahlungen aus Pharmakooperationen

Die Meilensteinzahlungen für pharmazeutische Partnerschaften beliefen sich im Jahr 2023 auf insgesamt 12,7 Millionen US-Dollar.

Pharmazeutischer Partner	Meilensteinzahlung	Programm
Merck & Co.	5,3 Millionen US-Dollar	Entwicklung der Immuntherapie
Novartis	4,9 Millionen US-Dollar	Genmodifikationsforschung
Andere Partner	2,5 Millionen Dollar	Verschiedene Forschungsprogramme

Potenzielle Verkäufe therapeutischer Produkte

Precigen meldete einen potenziellen Umsatz mit therapeutischen Produkten von 3,6 Millionen US-Dollar im Jahr 2023.

• Kandidat für die Behandlung von Prostatakrebs: 1,8 Millionen US-Dollar
• Therapeutischer Kandidat für seltene Krankheiten: 1,2 Millionen US-Dollar
• Andere therapeutische Kandidaten: 0,6 Millionen US-Dollar

Staatliche und private Forschungsstipendien

Die von Precigen im Jahr 2023 gesicherten Forschungsstipendien beliefen sich auf 5,1 Millionen US-Dollar.

Grant-Quelle	Zuschussbetrag	Forschungsbereich
National Institutes of Health (NIH)	3,2 Millionen US-Dollar	Immuntherapieforschung
Private Forschungsstiftungen	1,9 Millionen US-Dollar	Studien zur Genveränderung

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.