Precigen, Inc. (PGEN) Bundle
As a seasoned investor, how do you value a company like Precigen, Inc. (PGEN) when its stock is up over 375.91% in a year, yet its trailing twelve-month revenue is only around $4.34 million? The answer lies in its shift from a pure development-stage biotech to a commercial one, driven by the August 2025 FDA approval of its gene therapy, Papzimeos, for recurrent respiratory papillomatosis (RRP). This transition, which has pushed the company's market capitalization to approximately $1.19 billion, creates a fascinating financial puzzle: can the promise of its proprietary AdenoVerse platform finally outweigh the $227.1 million net loss reported for the first nine months of 2025?
Precigen, Inc. (PGEN) History
Given Company's Founding Timeline
The company's history is a story of strategic evolution, starting as a broad-scope biotechnology firm before narrowing its focus to precision medicine. The current entity, Precigen, Inc., is the result of a major corporate restructuring and name change from its original parent company, Intrexon Corporation.
Year established
The original company, Intrexon Corporation, was founded in 1998. Precigen, Inc. became the official name of the publicly traded entity in early 2020.
Original location
The company has consistently maintained its headquarters in Germantown, Maryland, US.
Founding team members
Thomas David Reed is credited as the founder of the original company. The company's current leadership, which drove the shift to its biopharmaceutical focus, is led by President and CEO Helen Sabzevari, PhD.
Initial capital/funding
Precigen (formerly Intrexon) has raised a total funding of $234 million across four funding rounds. Its largest single funding event was a Series D round in June 2011, which secured $91.8 million.
Given Company's Evolution Milestones
The company's trajectory shows a clear pivot from a diversified genetic engineering model to a focused clinical-stage biopharmaceutical approach, culminating in its first commercial product in 2025.
| Year | Key Event | Significance |
|---|---|---|
| 1998 | Founding of Intrexon Corporation | Established the foundational genetic engineering platform and intellectual property. |
| 2015 | Acquisition of Oxitec | Diversified the business into non-human applications, specifically genetically sterile insects, for $160 million. |
| April 2019 | Precigen formed as a subsidiary | Created a dedicated focus on human gene and cell therapy, signaling a strategic shift. |
| Early 2020 | Intrexon adopts the name Precigen, Inc. | Completed the corporate transformation, narrowing focus exclusively to human gene editing and biopharmaceuticals. |
| February 2025 | FDA accepts BLA for PRGN-2012 (PAPZIMEOS™) and grants Priority Review | Accelerated the path to market for the lead candidate for Recurrent Respiratory Papillomatosis (RRP). |
| August 2025 | FDA grants full approval to PAPZIMEOS™ | Marks the pivotal transition to a commercial-stage biopharmaceutical company. |
Given Company's Transformative Moments
The most transformative period for Precigen has defintely been the shift in its core business model and the commercial launch of its first approved therapy in 2025. This move from a research-heavy, platform-licensing model to a product-focused, commercial-stage company is a massive operational and financial undertaking.
The decision in early 2020 to shed the Intrexon name and focus entirely on human therapeutics under the Precigen banner was the critical moment. It simplified the narrative, allowing the company to concentrate its capital and scientific talent on high-value, unmet medical needs like RRP. This focus is what led to the August 2025 FDA approval of PAPZIMEOS™ (zopapogene imadenovec-drba), the first approved therapy for adults with RRP.
Here's the quick math on the near-term financial impact: The company's cash position was $81.0 million as of March 31, 2025, with a net loss of $54.2 million in Q1 2025. To fund the commercial launch of PAPZIMEOS™, Precigen secured a non-dilutive credit facility in September 2025 for up to $125 million, with $100 million funded at closing. This immediately boosted their balance sheet to $123.6 million in cash and investments by September 30, 2025.
- Securing Commercial Funding: The $100 million initial tranche from Pharmakon Advisors in Q3 2025 provides the financial runway to execute the PAPZIMEOS™ launch.
- Transition to Sales: Q3 2025 revenue was $2.92 million, but the commercial team has already engaged with 90% of the target institutions for RRP, covering a significant portion of the estimated 27,000 adult RRP patients in the US.
- Clinical Validation: The pivotal trial data showed 51% of RRP patients achieved a complete response, remaining surgery-free for at least 12 months, with some durable responses lasting three years. This data is the engine for commercial success.
The company's mission is now laser-focused on advancing gene and cell therapies in immuno-oncology, autoimmune disorders, and infectious diseases, a clear mandate you can read more about here: Mission Statement, Vision, & Core Values of Precigen, Inc. (PGEN).
Precigen, Inc. (PGEN) Ownership Structure
Precigen, Inc.'s ownership structure is dominated by a single, powerful insider and his affiliated entities, which is a critical point for any investor to understand. This concentration of shares means the company's strategic direction is heavily influenced by a few key stakeholders, a common trait in early-stage biotech where capital is often sourced from a small group of high-net-worth individuals or specialized funds.
Precigen, Inc.'s Current Status
Precigen, Inc. is a publicly traded biopharmaceutical company, listed on the Nasdaq Global Select Market (NasdaqGS) under the ticker symbol PGEN. As of November 2025, the company has a market capitalization of approximately $1.37 billion. Being public means its financial and strategic decisions are subject to SEC scrutiny and shareholder votes, but the high concentration of insider ownership significantly centralizes control. You can find a deeper dive into their financials here: Breaking Down Precigen, Inc. (PGEN) Financial Health: Key Insights for Investors
Precigen, Inc.'s Ownership Breakdown
The company's governance is heavily weighted toward its largest affiliate shareholder, Randal J. Kirk, who is also the Executive Chairman. This structure means major decisions, like asset prioritization or capital allocation, are defintely steered from the top. The table below breaks down the ownership by major category, using the most recent data available in late 2025.
| Shareholder Type | Ownership, % | Notes |
|---|---|---|
| Insider/Affiliate (Third Security, LLC) | 37.31% | Primarily held by Third Security, LLC, an investment firm affiliated with Executive Chairman Randal J. Kirk. |
| Institutional Investors | 33.51% | Includes major funds like BlackRock, Inc., The Vanguard Group, Inc., and Patient Capital Management, LLC. |
| Public/Retail and Other | 29.18% | The remaining float held by individual investors and smaller funds. |
Here's the quick math: The largest single holder, Third Security, LLC, controls over a third of the company. Plus, institutional investors hold another significant chunk, making the publicly available float for retail investors relatively small.
Precigen, Inc.'s Leadership
The leadership team is a mix of seasoned biotech executives and financial operators, with an average management team tenure of 5.8 years, which is a solid number for a clinical-stage company. The board's average tenure is even longer, standing at 11.6 years. This stability suggests a consistent strategic vision, but also a long-term commitment to the current direction.
- Randal J. Kirk: Executive Chairman. His influence is paramount, given his role and his affiliated entities' massive shareholding.
- Helen Sabzevari, PhD: President, Chief Executive Officer (CEO), and Director. She has been in the CEO role since January 2020 and her total yearly compensation is around $5.43 million.
- Rutul R. Shah: Chief Operating Officer (COO). He oversees the operational aspects, which is crucial as the company progresses toward commercialization of its lead candidate, PRGN-2012.
- Harry Thomasian Jr.: Chief Financial Officer (CFO). He manages the balance sheet, which showed $123.6 million in cash, cash equivalents, and investments as of September 30, 2025.
- Phil Tennant: Chief Commercial Officer (CCO). His focus is on the commercial launch of Papzimeos, which was approved in August 2025.
The team is currently focused on turning clinical success into commercial revenue, especially following the FDA approval of Papzimeos. This shift from R&D to sales execution is the near-term opportunity, but it also introduces new commercial risks.
Precigen, Inc. (PGEN) Mission and Values
Precigen, Inc. is fundamentally driven by a dual purpose: to discover and commercialize next-generation gene and cell therapies while making them cost-conscious for patients with high unmet medical needs. This is a tough balancing act-great science needs a greater cause.
As a seasoned analyst, I see this mission as a clear strategic anchor, especially considering the company's transition to a commercial-stage entity following the FDA approval of PAPZIMEOS in August 2025. The focus is on precision medicine, which means highly targeted, less-toxic treatments.
Precigen, Inc.'s Core Purpose
The company's core purpose is to tackle intractable diseases using its proprietary platforms. This is evident in their 2025 financials, where the nine months ended September 30, 2025, saw total revenues of $5.1 million, a significant jump from the prior year, but still accompanied by a net loss of $227.1 million as they heavily invest in this mission and the commercial launch of their first approved product. That's the cost of being on the cutting edge.
Official mission statement
Precigen, Inc.'s formal mission is a clear statement of intent, focusing on the entire product lifecycle from lab to patient.
- Discover, develop, and commercialize next-generation gene and cell therapies.
- Focus on core therapeutic areas: immuno-oncology, autoimmune disorders, and infectious diseases.
The mission is precise, telling you exactly what they do and where they play, which helps investors and partners defintely understand the focus. Mission Statement, Vision, & Core Values of Precigen, Inc. (PGEN).
Vision statement
The vision statement adds a critical layer to the mission, addressing both the scientific outcome and the practical reality of healthcare economics. It's not just about a cure; it's about accessibility.
- Develop life-saving and cost-conscious therapies.
- Utilize cutting-edge therapeutic and platform technologies.
- Target patients with unmet medical need.
The emphasis on 'cost-conscious' is a key differentiator in the high-cost gene and cell therapy space. They aim to deliver value to all stakeholders, which is why their cash, cash equivalents, and investments of $123.6 million as of September 30, 2025, are so important-it funds the journey toward affordability and scale. Here's the quick math: that cash position is expected to fund operations into 2026, beyond the initial commercial launch.
Precigen, Inc. Core Principles (Values)
While not a traditional list of 'Integrity' or 'Respect,' Precigen, Inc. outlines its core operating principles that guide how they execute their mission and create value for investors. These principles are the operational DNA of the company.
- Fiscal Strength: Maintaining financial discipline to ensure longevity and fund the pipeline.
- Active Portfolio Management: Continuously evaluating and prioritizing development programs, such as their AdenoVerse and UltraCAR-T platforms.
- Rapid Execution: Moving scientific breakthroughs efficiently from proof-of-concept through to commercialization.
These values translate directly to action. For example, the rapid advancement of their lead product, PAPZIMEOS, to an FDA-approved therapy in 2025 demonstrates the 'Rapid Execution' principle in practice. The company's internal culture is built around getting life-saving science to market quickly.
Precigen, Inc. slogan/tagline
The company's official tagline is a concise summary of its entire corporate philosophy and approach to medicine.
- Advancing Medicine with Precision®.
This tagline highlights their use of precision technology-synthetic biology-to engineer gene and cell therapies, which is the technical foundation for their entire pipeline. It's a simple, powerful statement that anchors their brand in scientific rigor.
Precigen, Inc. (PGEN) How It Works
Precigen, Inc. operates by engineering the next generation of gene and cell therapies using its proprietary synthetic biology platforms to create precision medicines for hard-to-treat diseases. The company's core value creation shifted in 2025, moving from a pure research and development (R&D) model to a commercial-stage biopharmaceutical company following the FDA approval of its lead product. Exploring Precigen, Inc. (PGEN) Investor Profile: Who's Buying and Why?
This means the company now makes money through product sales, specifically its recently approved gene therapy, while continuing to advance its clinical pipeline through R&D and strategic collaborations.
Given Company's Product/Service Portfolio
| Product/Service | Target Market | Key Features |
|---|---|---|
| PAPZIMEOS (zopapogene imadenovec-drba) | Adults with Recurrent Respiratory Papillomatosis (RRP) | First and only FDA-approved therapy; off-the-shelf AdenoVerse® gene therapy; designed to eliminate or reduce the need for repeated surgeries. |
| UltraCAR-T® Platform (e.g., PRGN-3006) | Patients with hematological and solid tumors (e.g., Acute Myeloid Leukemia) | Non-viral Sleeping Beauty system; rapid, overnight manufacturing using UltraPorator®; administered one day after gene transfer; lower cost potential. |
| AdenoVerse® Platform (e.g., PRGN-2009) | Patients with Human Papillomavirus (HPV)-associated cancers | Utilizes proprietary gorilla adenovectors; large genetic payload capacity; safe for repeat administration; off-the-shelf availability. |
Given Company's Operational Framework
The operational framework is centered on a streamlined 'discovery to commercialization' engine, shifting resources heavily toward launching its first approved product and selectively advancing its high-potential pipeline programs.
- Precision Engineering: The UltraVector® platform is the foundation, using advanced DNA construction and computational models to design complex, multi-gene therapeutic programs.
- Off-the-Shelf Manufacturing: The AdenoVerse® platform utilizes proprietary cell lines and scalable production methods to create 'off-the-shelf' gene therapies, which are easier and faster to deliver than patient-specific treatments.
- Rapid Cell Therapy Production: The UltraCAR-T® platform uses the proprietary UltraPorator® system to enable a high-throughput, semi-closed, overnight manufacturing process for its CAR-T cell therapies at the medical center, cutting down the typical weeks-long wait time. That's defintely a game-changer for patients.
- Commercial Launch Focus: Following the August 2025 FDA approval of PAPZIMEOS, the company rapidly deployed a sales team, engaging over 90% of target institutions by September 2025. This focus is driving the transition to a revenue-generating model.
- Financial Runway: As of September 30, 2025, the company had $123.6 million in cash, cash equivalents, and investments, which, combined with projected PAPZIMEOS revenues, is expected to fund operations to cash flow break-even.
Given Company's Strategic Advantages
Precigen's market success hinges on its differentiated technology and strategic positioning in rare and high-unmet-need diseases, allowing it to compete effectively against larger biotech firms.
- First-Mover Advantage in RRP: PAPZIMEOS is the first and only FDA-approved therapeutic for adults with RRP, a chronic disease affecting approximately 27,000 adults in the U.S. This gives them immediate market exclusivity and pricing power.
- Proprietary Technology Moat: The UltraVector®, UltraCAR-T®, and AdenoVerse® platforms are proprietary. The use of gorilla adenovectors in AdenoVerse is a key advantage, as humans have low pre-existing immunity to them, allowing for repeat dosing.
- Manufacturing Efficiency: The UltraCAR-T® overnight manufacturing process significantly reduces the cost and logistical complexity associated with traditional CAR-T therapies, which is a major competitive barrier for rivals.
- Strategic Financial De-risking: The company secured up to $125 million in non-dilutive financing in September 2025, with the first tranche of $100 million received. This bolsters liquidity without diluting existing shareholders, which is smart capital management given the $227.1 million net loss reported for the nine months ended September 30, 2025.
Precigen, Inc. (PGEN) How It Makes Money
Precigen, Inc. makes money through a hybrid model, transitioning from a research and development (R&D) stage, where revenue is primarily generated from collaboration and licensing agreements, to a commercial-stage biopharmaceutical company selling its first FDA-approved gene therapy product, PAPZIMEOS (zopapogene imadenovec-drba).
Precigen, Inc.'s Revenue Breakdown
The company's revenue profile for the third quarter of fiscal year 2025 (Q3 2025) shows a significant reliance on partnership income, though product sales are starting to emerge following the August 2025 FDA approval of PAPZIMEOS. Total revenue for Q3 2025 surged 206.9% year-over-year to $2.92 million.
| Revenue Stream | % of Total (Q3 2025) | Growth Trend |
|---|---|---|
| Collaboration and Licensing Revenue | 62.3% | Increasing (Volatile) |
| Service Revenue | 32.3% | Stable/Increasing |
| Product Revenue | 5.5% | Strongly Increasing (from a low base) |
Here's the quick math: Collaboration and licensing income of $1.82 million drove the majority of Q3 2025 revenue, largely due to recognizing deferred revenue from a terminated exclusive channel collaboration agreement. Product revenue, while only $162,000 in Q3 2025, is the new, high-growth stream following the commercial launch of PAPZIMEOS. Service revenue, at $942,000, provides a more consistent, albeit smaller, base.
Business Economics
The core economic engine is shifting from milestone payments to a high-margin, specialty pharmaceutical model centered on PAPZIMEOS, a non-replicating adenoviral vector-based immunotherapy. This is a classic Orphan Drug strategy: target a rare, debilitating disease-Recurrent Respiratory Papillomatosis (RRP)-with a first-in-class treatment that offers a high-value clinical outcome.
The value proposition is clear: PAPZIMEOS aims to reduce or eliminate the need for repeated surgical debulking procedures, which is the current standard of care for RRP. Clinical data shows a 51% complete response rate at 12 months, with durability continuing for a median of 36 months in responders. This durable response justifies a premium price point, although the exact per-course cost is not publicly disclosed. To be fair, the company expects a gross-to-net revenue adjustment in the high teens to low 20s percentage range.
- Pricing Power: The product is the first and only FDA-approved therapy for adult RRP, granting it a near-monopoly in a niche market.
- Payer Access: The company has rapidly secured coverage for over 100 million lives through private health insurance, Medicare, and Medicaid, which is crucial for a specialty drug launch.
- Cost Structure: The company is investing heavily in commercialization, with Selling, General and Administrative (SG&A) expenses increasing by 144% (or $14.2 million) in Q3 2025 to support the PAPZIMEOS launch. This upfront cost is necessary to capture the market, but the manufacturing cost of goods sold (COGS) for a gene therapy, while proprietary, is expected to allow for high gross margins once volume scales.
You can see the full strategic context in the Mission Statement, Vision, & Core Values of Precigen, Inc. (PGEN).
Precigen, Inc.'s Financial Performance
Precigen's financial performance in Q3 2025 reflects a company in a high-cost transition phase, balancing strong revenue growth with significant operational investment and non-cash accounting charges. The company is defintely burning cash to achieve future commercial success.
- Total Revenue: Q3 2025 revenue was $2.92 million, a 206.9% increase year-over-year, significantly beating analyst expectations.
- Net Loss: The net loss attributable to common shareholders for Q3 2025 was a substantial $325.3 million, or $(1.06) per share. What this estimate hides is that $0.95 of that per-share loss was due to non-cash accounting items, primarily a $179.0 million non-cash deemed dividend on preferred stock and a $111.5 million non-cash increase in the fair value of warrant liabilities.
- Cash Position: As of September 30, 2025, the company maintained a strong liquidity position with cash, cash equivalents, and investments totaling $123.6 million.
- Cash Runway: Management projects that the current cash position, combined with a $125 million non-dilutive credit facility secured in September 2025, is expected to fund operations to cash flow break-even by late 2026.
- R&D Investment: Research and development expenses increased by 9% in Q3 2025, or $1.0 million, primarily driven by increased manufacturing and regulatory costs related to PAPZIMEOS.
Precigen, Inc. (PGEN) Market Position & Future Outlook
Precigen, Inc. is transitioning from a purely clinical-stage entity to a commercial one, with its market position anchored by the recent FDA approval of PAPZIMEOS. The company's future outlook hinges on successful commercialization in its rare disease niche and the continued, capital-efficient advancement of its proprietary non-viral gene and cell therapy platforms.
The core of the strategy is simple: dominate the Recurrent Respiratory Papillomatosis (RRP) market with the first approved therapy, and use the proprietary UltraCAR-T and AdenoVerse platforms to create a differentiated pipeline in immuno-oncology. You can find a deeper dive into the company's financial stability in Breaking Down Precigen, Inc. (PGEN) Financial Health: Key Insights for Investors.
Competitive Landscape
In the broader cell and gene therapy space, Precigen is a niche player with a small market footprint, but it holds a commanding position in the specific therapeutic area of its first commercial product. The global cell and gene therapy market is projected to be around $8.94 billion in 2025, which provides context for Precigen's projected $13.70 million in annual revenue.
| Company | Market Share, % | Key Advantage |
|---|---|---|
| Precigen, Inc. | <0.2% | First-to-market FDA-approved RRP therapy (PAPZIMEOS); proprietary non-viral UltraCAR-T platform. |
| Legend Biotech | ~21.3% | Market leader in multiple myeloma CAR-T with CARVYKTI; high gross margins (>90%). |
| uniQure N.V. | ~0.2% | Approved gene therapy (HEMGENIX, partnered); breakthrough status for Huntington's disease candidate (AMT-130). |
Here's the quick math: Precigen's estimated 2025 revenue of $13.70 million against the roughly $8.94 billion market size puts its share at less than 0.2% in the overall industry.
Opportunities & Challenges
The company's trajectory is a classic high-risk, high-reward biotech story. They have a massive first-mover advantage in RRP, but they still burn cash to fund the rest of their pipeline.
| Opportunities | Risks |
|---|---|
| Commercial Launch of PAPZIMEOS: First and only FDA-approved therapy for adult RRP, ensuring near-100% market capture in this indication. | Cash Burn and Profitability: Q1 2025 cash burn was $16.9 million; breakeven is forecast to be pushed back to 2027. |
| UltraCAR-T Pipeline: Advancement of PRGN-3006 (ovarian cancer) and PRGN-3005 (myeloid malignancies) using a non-viral, non-ablative approach, which is a key differentiator. | Clinical Trial Setbacks: Any delay or negative data in the UltraCAR-T or AdenoVerse pipeline could severely impact the stock, as future value is tied to these assets. |
| Strengthened Balance Sheet: Secured up to $125 million in non-dilutive financing in September 2025, providing a longer runway for commercialization. | Insider Sentiment and Dilution: A director sold approximately $12.3 million in stock in November 2025, which can signal a lack of confidence to the market. |
Industry Position
Precigen is positioned as a specialized, platform-centric biotech, not a broad-spectrum pharmaceutical company.
- PAPZIMEOS is a critical, near-term revenue driver; its successful commercial rollout is defintely the most important catalyst for 2026.
- The company's core technological strength lies in its proprietary platforms, particularly UltraCAR-T, which offers a potentially safer, non-viral, and less complex manufacturing process compared to traditional chimeric antigen receptor T-cell (CAR-T) therapies like those from Legend Biotech or Novartis.
- While the Q3 2025 revenue of $2.92 million beat analyst expectations, the net loss of $0.11 per share highlights the continuing challenge of converting platform potential into sustained profitability.
- The focus on rare diseases (RRP) and novel approaches in immuno-oncology allows them to bypass direct competition with big pharma's established CAR-T products, but it also limits the immediate total addressable market.
To be fair, the company's valuation is driven by the potential of its pipeline, not its current revenue. If the UltraCAR-T platform shows compelling Phase 2 data, the entire valuation narrative changes overnight.

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