Precigen, Inc. (PGEN) Business Model Canvas

Precigen, Inc. (PGEN): Business Model Canvas [Dec-2025 Updated]

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You're trying to map out Precigen, Inc.'s strategy as they make that tough jump from a research-focused outfit to a company actually selling a product, which is defintely the make-or-break moment for any biotech. We're talking about a firm that needs its new PAPZIMEOS launch to land perfectly, especially when you see they posted a net loss of $227.1 million for the first three quarters of 2025, leaving them with $123.6 million in cash as of September 30th. The entire business model hinges on turning those key activities-like running clinical trials and commercializing PAPZIMEOS-into the revenue streams needed to extend that runway. This is where the rubber meets the road. See the full nine-block breakdown below to understand the risks and the potential payoff.

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

You're looking at how Precigen, Inc. is structuring its commercial and development efforts through external relationships, which is critical now that PAPZIMEOS has FDA approval. Honestly, for a company moving from clinical to commercial, these partnerships are the engine room.

The relationship with the National Cancer Institute (NCI) remains a key academic/research partnership, governed by a cooperative research and development agreement (CRADA). This collaboration supports the ongoing Phase 2 clinical trials for PRGN-2009, which is an investigational off-the-shelf AdenoVerse gene therapy. These trials are focused on HPV-associated cancers, specifically in recurrent/metastatic cervical cancer and newly diagnosed HPV-associated oropharyngeal cancer. While the Phase 2 trials are ongoing, the focus for near-term commercialization is clearly on PAPZIMEOS.

For the launch of PAPZIMEOS (zopapogene imadenovec-drba), which the FDA approved on August 14, 2025, Precigen tapped EVERSANA to lead the U.S. commercialization strategy. This partnership, which began in late 2024 for pre-approval planning, immediately activated post-approval launch services. EVERSANA is deploying its full-scale operation across several critical areas:

  • Market access support.
  • Field deployment.
  • Medical affairs.
  • Marketing services.

To fund this commercial scale-up without immediately diluting equity, Precigen secured significant non-dilutive capital. The partnership with investment funds managed by Pharmakon Advisors, LP, is a landmark financing event. This credit facility provides up to $\$125$ million in committed capital, which is a smart move to preserve ownership structure during a growth phase. Here's the quick math on that facility:

Financing Component Amount/Term Details
Total Committed Facility $\$125$ million Non-dilutive financing to fund U.S. commercialization and expansion.
First Tranche Funded $\$100$ million Funded at the closing date of the agreement on September 3, 2025.
Second Tranche Availability $\$25$ million Can be drawn at Precigen's discretion through March 31, 2027.
Interest Rate $6.50\%$ plus 3-month SOFR Includes a SOFR floor of $3.75\%$.
Maturity Date Fifth anniversary of closing Provides a multi-year runway for the initial capital deployment.

Also, to be fair, this financing is complemented by additional debt, specifically a $\$125$ million total in debt from BioPharma Credit PLC and BioPharma Credit Investments V, which diversifies funding sources further.

For the actual delivery and patient support of PAPZIMEOS, which is the first and only FDA-approved therapy for recurrent respiratory papillomatosis (RRP), Precigen established a dedicated distribution channel. They selected Biologics by McKesson, operating under the InspiroGene by McKesson banner, as the exclusive provider for specialty pharmacy and patient hub services. This is crucial for a complex cell and gene therapy launch. Precigen identified the prevalence of RRP in the U.S. to be approximately 27,000 adult patients, so the specialty pharmacy network needs to be highly targeted.

  • Partner: Biologics by McKesson (InspiroGene).
  • Service: Exclusive specialty pharmacy and patient hub services.
  • Target Population Size: Approximately 27,000 adult RRP patients in the U.S.

The reliance on specialized partners like EVERSANA and Biologics by McKesson shows Precigen is using external expertise to manage the complexity of launching a novel therapy for a rare disease, which is definitely the right call when you're focused on pipeline advancement.

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

Research and development of gene and cell therapies

Precigen, Inc. (PGEN) dedicates significant resources to advancing its therapeutic pipeline, with R&D expenses fluctuating based on clinical stage and commercial readiness activities. For the three months ended September 30, 2025, Research and development expenses increased by $1.0 million, or 9%, compared to the same period in 2024. This increase was linked to manufacturing expenses for PAPZIMEOS before its approval and professional fees for regulatory filings. Conversely, for the three months ended March 31, 2025, Research and development expenses decreased by $3.8 million, or 27%, compared to the first quarter of 2024, partly due to the closure of ActoBio operations in late 2024.

The company's core technology platforms are central to this activity:

  • AdenoVerse library, leveraging UltraVector technology, is used for gene therapies.
  • UltraCAR-T technology utilizes a non-viral Sleeping Beauty system.

Managing and advancing clinical trials (e.g., UltraCAR-T, AdenoVerse)

Advancing clinical programs involves executing trials and preparing regulatory submissions for key candidates. The AdenoVerse platform candidate, PRGN-2012 (PAPZIMEOS), reached a major milestone with the FDA accepting its Biologics License Application (BLA) with a Priority Review, targeting an action date of August 27, 2025.

Key clinical data points for the PAPZIMEOS pivotal study include:

Metric Data Point Context/Cutoff
Complete Response (CR) Rate 51% (18 out of 35) patients Initial pivotal study data (May 2025)
CR Durability (Median) Beyond 12 months Initial pivotal study data (May 2025)
Median Follow-up for CRs 30 months Initial pivotal study data (May 2025)
Long-Term CR Maintenance 83% (15 out of 18) maintained CR September 19, 2025 data cutoff
Median Follow-up (Long-Term) 36 months (range 27 to 37 months) September 19, 2025 data cutoff

The UltraCAR-T program for PRGN-3006 in Acute Myeloid Leukemia (AML) completed enrollment for its Phase 1b trial as of May 2025. However, the Company paused all other UltraCAR-T programs, including PRGN-3005 and PRGN-3007, to focus resources.

Commercialization and launch of PAPZIMEOS (PRGN-2012)

The transition to a commercial-stage company is centered on the launch of PAPZIMEOS. The product received full FDA approval in August 2025 with a broad label, making it the first and only FDA-approved treatment for adults with Recurrent Respiratory Papillomatosis (RRP). The US commercial launch execution is rapid:

  • Over 100 patients registered in the PAPZIMEOS Patient Hub to date.
  • Over 90% of target institutions engaged since the sales team deployment in September 2025.
  • More than 100 million lives covered by private health insurance to date.
  • The company submitted a Marketing Authorization Application to the European Medicines Agency in November 2025.

This commercial activity is reflected in the Selling, General and Administrative (SG&A) expenses, which increased by $14.2 million, or 144%, for the three months ended September 30, 2025, compared to the prior year period. This increase was primarily due to a $9.0 million increase in costs related to PAPZIMEOS commercial readiness, including sales and marketing efforts.

Protecting and licensing proprietary technology platforms

Financial data related to licensing activity is captured within revenue reporting. Total revenues for the third quarter of 2025 increased by $2.0 million compared to the three months ended September 30, 2024. This revenue increase was primarily driven by the recognition of the remaining deferred revenue associated with the termination of an exclusive channel collaboration agreement. The UltraCAR-T program is a focus for future advancement, with management looking to form a strategic partnership or collaboration agreement to advance these programs.

Manufacturing and quality control of therapeutic candidates

Manufacturing activities are integrated into both R&D expenses and inventory capitalization. Costs incurred in manufacturing PAPZIMEOS prior to its approval were expensed as part of R&D expenses for the three months ended September 30, 2025. These R&D increases were partially offset by the capitalization of inventory-related costs subsequent to the FDA's approval of PAPZIMEOS. For the UltraCAR-T platform, the manufacturing process for PRGN-3006 has demonstrated a 100% manufacturing success rate based on historical data.

The company's financial position as of late 2025 supports these ongoing operations:

Financial Metric Amount/Date Context
Cash, Cash Equivalents, and Investments $123.6 million As of September 30, 2025
Non-Dilutive Financing Secured Up to $125 million credit facility Announced in September 2025
First Tranche of Financing Received $100 million September 2025
Projected Cash Flow Break-even By the end of 2026 Company expectation
Q3 2025 Revenue $2.92 million Reported November 13, 2025

The net loss attributable to common shareholders for the three months ended September 30, 2025, was $(1.06) per basic and diluted share.

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

You're looking at the core assets Precigen, Inc. (PGEN) relies on to execute its precision medicine strategy, especially now that PAPZIMEOS has achieved full FDA approval in August 2025. These resources are what underpin their ability to generate revenue and advance the pipeline.

The most tangible resource is the capital base. As of September 30, 2025, Precigen, Inc. (PGEN) reported cash, cash equivalents, and investments totaling $123.6 million. This balance, bolstered by a credit facility draw in September 2025, is expected to fund operations to cash flow break-even.

The intellectual property portfolio forms the foundation of their competitive moat. This includes the proprietary technology platforms that enable their therapeutic development:

  • Proprietary AdenoVerse technology platform.
  • Proprietary UltraCAR-T technology platform.

The scale of this IP, as of late 2025 data, is quite substantial, representing years of research investment:

IP Metric Amount
Total Documents Applications and Grants 1,441
Total Patent Families 631
Granted Patents 132

This portfolio provides market exclusivity for their gene and cell engineering innovations.

The human capital is another critical, though less easily quantified, resource. The specialized scientific and clinical talent base is essential for managing the PAPZIMEOS launch and advancing the pipeline, including the PRGN-2009 AdenoVerse Immunotherapy program. As of October 2025, the company reported a total employee count of 25.

To give you a sense of the operational scale these resources are supporting, for the nine months ended September 30, 2025, Precigen, Inc. reported total revenues of $5.1 million. However, the financial reality reflects heavy investment, with the net loss attributable to common shareholders for the three months ended September 30, 2025, being $(1.06) per basic and diluted share, heavily impacted by non-cash items.

Here's a quick look at the financial context surrounding these key resources as of the end of Q3 2025:

  • Cash, cash equivalents, and investments: $123.6 million (as of 9/30/25).
  • Total Debt: $98.19 million (based on LTM data).
  • Net Cash Position: $22.94 million (Cash minus Total Debt).
  • Total Assets: $171.3 million.

Finance: draft 13-week cash view by Friday.

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.


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