Here are 1-3 brief analogies for Precigen (PGEN):

• An early-stage Moderna or BioNTech, focused on developing advanced gene and cell therapies.
• A high-potential, high-risk biotech aiming to be the next Amgen or Gilead Sciences, specializing in cutting-edge cell and gene therapy platforms.

• UltraCAR-T® Platform: A next-generation, non-viral, gene-edited CAR-T therapy platform designed for rapid manufacturing and enhanced safety in treating various cancers.
• AdenoVerse™ Platform: A proprietary gene therapy delivery platform that utilizes adenovirus vectors for diverse therapeutic applications, including oncology and infectious diseases.
• ActoBiotics™ Platform: An oral biotherapeutic delivery platform using modified bacteria to deliver therapeutic proteins or peptides to the gastrointestinal tract or for systemic effects.

Precigen (PGEN) primarily sells to other companies, typically biotechnology or pharmaceutical companies, through collaborations, licensing agreements, and partnerships for the development and commercialization of its gene and cell therapies and related technologies.

According to Precigen's most recent annual report (10-K), no single customer accounted for more than 10% of its total revenue. Therefore, Precigen does not have "major customers" that meet this quantitative threshold for revenue concentration.

However, examples of companies with whom Precigen has formed significant collaborations or licensing agreements, representing its customer base, include:

• Revance Therapeutics, Inc. (NASDAQ: RVLS): Precigen entered into a non-exclusive license agreement with Revance in 2023 for its Transgene Expression Modulator (TEM) platform for certain aesthetic applications.
• Merck KGaA, Darmstadt, Germany (OTC: MKGAF; XTRA: MRK.DE): While revenue from the primary collaboration agreement has largely concluded, Merck KGaA was a significant strategic partner in the past for the development of certain immunotherapies, representing the type of major pharmaceutical company Precigen seeks to collaborate with.

• FUJIFILM Diosynth Biotechnologies U.S.A., Inc. (Parent Company: Fujifilm Corporation, Symbol: FUJIY)
• Aldevron (Parent Company: Danaher Corporation, Symbol: DHR)
• Catalent, Inc. (Symbol: CTLT)

Helen Sabzevari, PhD, President and CEO

Dr. Sabzevari became President and CEO of Precigen in 2018, and then CEO of the broader company in January 2020 when Intrexon adopted the Precigen name. She co-founded Compass Therapeutics in 2015, serving as its Chief Scientific Officer until 2017. Her career includes executive leadership roles at Merck KGaA/EMD Serono and the National Institutes of Health (NIH), where she received an NIH merit award for her immuno-oncology work. Dr. Sabzevari has focused on developing gene and cell treatments for autoimmune disorders, infectious diseases, and cancer, and was involved in the development of Adalimumab, a major checkpoint inhibitor.

Harry Thomasian Jr., Chief Financial Officer

Mr. Thomasian was appointed Chief Financial Officer of Precigen in October 2021. He brings over 35 years of international business experience in accounting, corporate financings, and advisory services. Before joining Precigen, Mr. Thomasian spent 35 years at Ernst & Young LLP (EY), where he most recently served as a senior client service partner, the Baltimore office Growth Markets Leader, and co-leader for the firm's life sciences practice for the Chesapeake Region.

Rutul R. Shah, Chief Operating Officer

Mr. Shah has served as Precigen's Chief Operating Officer since October 2022. He joined the company in 2014 and has held roles of increasing responsibility, including Vice President & Head of Operations and Senior Director of Operations. Prior to Precigen, Mr. Shah accumulated over a decade of scientific experience in developing protein, antibody, gene, and cell therapy drugs at companies such as Zyngenia, Teva Biopharmaceuticals USA, CoGenesys, and Human Genome Sciences.

Donald P. Lehr, Chief Legal Officer

Mr. Lehr serves as the Chief Legal Officer at Precigen. He is responsible for the company's legal affairs.

Phil Tennant, Chief Commercial Officer

Mr. Tennant holds the position of Chief Commercial Officer at Precigen.

Here are the key risks to Precigen's (PGEN) business:

1. Financial Losses and Need for Additional Capital: Precigen has a history of substantial net losses and a high cash burn rate. Despite recent revenue growth, the company's net loss significantly increased in the third quarter of 2025, raising questions about liquidity and cash burn. With a cash runway extending only into 2026 based on historical data, Precigen will likely require additional financing for commercialization efforts and to sustain its ongoing operations. Such financing could potentially lead to the dilution of existing shareholders or impose restrictive covenants.
2. Reliance on a Single Product (Papzimeos): Precigen's near-term financial success is heavily dependent on the commercial performance of Papzimeos (formerly PRGN-2012), its recently FDA-approved therapy for recurrent respiratory papillomatosis (RRP). While the approval is a significant milestone, the company's ability to generate sustainable revenue and achieve profitability hinges on the market acceptance and successful commercialization of this single product. This concentration introduces significant execution risk.
3. Clinical Trial and Regulatory Risks for Pipeline Products: Precigen's long-term growth and diversification rely on the successful development and regulatory approval of its pipeline products beyond Papzimeos. The biotechnology industry inherently faces high failure rates for drugs in clinical trials, and negative or inconclusive results can lead to the discontinuation of trials or the need for extensive additional studies. Furthermore, future product candidates are subject to potential regulatory delays or rejections, which could materially and adversely affect the company's business and prospects.

The rapid advancement and increasing clinical success of gene-editing technologies (such as CRISPR/Cas9) by competing biotechnology companies represent a clear emerging threat. These technologies offer a potentially more precise and durable method for modifying genes and cells compared to Precigen's current gene delivery platforms (e.g., UltraCAR-T and AdenoVerse). As gene-edited cell therapies (such as allogeneic CAR-T cells modified with CRISPR) and in vivo gene editing therapies progress through clinical trials and demonstrate superior efficacy, safety, or manufacturability, they could disrupt the market for gene and cell therapies, directly competing with and potentially superseding Precigen's pipeline assets in oncology and other therapeutic areas.

Precigen (PGEN) is a biopharmaceutical company focused on developing gene and cell therapies in immuno-oncology, autoimmune disorders, and infectious diseases, leveraging its AdenoVerse and UltraCAR-T platforms.

Main Products and Addressable Markets:

• PRGN-2012 (AdenoVerse Gene Therapy for Recurrent Respiratory Papillomatosis - RRP):

  • U.S. Market: Approximately 27,000 adult patients.
  • Global Market (outside U.S.): More than 125,000 patients.
  • The potential for PRGN-2012 in the U.S. is estimated to exceed $1 billion in peak annual sales, based on a projected 15% market penetration and an estimated annual net price of $250,000 per patient. This product is currently prioritized by the company.

• PRGN-2009 (AdenoVerse Gene Therapy for HPV-associated Cancers):

  • PRGN-2009 is an investigational therapy for HPV-associated cancers, including recurrent/metastatic cervical cancer and newly diagnosed HPV-associated oropharyngeal cancer. The addressable market size for this product is not explicitly provided in terms of patient numbers or market value in the available information.

• UltraCAR-T Programs (e.g., PRGN-3006, PRGN-3008, PRGN-3005, PRGN-3007):

  • Precigen's UltraCAR-T programs are in various stages of development for indications such as Acute Myeloid Leukemia (PRGN-3006), CD19 solid tumors and autoimmune disorders (PRGN-3008), and advanced, recurrent platinum-resistant ovarian cancer (PRGN-3005). Specific addressable market sizes (patient numbers or market value) for these individual UltraCAR-T products are not explicitly provided in the available information. The company is actively seeking a partner to further fund and advance its UltraCAR-T pipeline.

Precigen (PGEN) is poised for significant revenue growth over the next 2-3 years, driven primarily by the anticipated commercialization of its lead product candidate and the advancement of its innovative pipeline. The key drivers include:

1. Commercialization of PRGN-2012 (PAPZIMEOS) for Recurrent Respiratory Papillomatosis (RRP)

   The most immediate and substantial driver of future revenue growth for Precigen is the expected launch and commercialization of PRGN-2012, now known as PAPZIMEOS, for the treatment of adult recurrent respiratory papillomatosis (RRP). The FDA granted priority review to the Biologics License Application (BLA) for PRGN-2012, with a PDUFA target action date set for August 27, 2025. Precigen anticipates commencing commercial revenues in the second half of 2025, following potential FDA approval. Analysts are optimistic about its revenue potential, with some projecting peak annual sales exceeding $1 billion, as PAPZIMEOS could become the first FDA-approved treatment for RRP and benefit from market exclusivity. The company is actively advancing its commercial and manufacturing readiness in anticipation of this launch.

2. Advancement of PRGN-3006 for Acute Myeloid Leukemia (AML)

   Another key driver is the continued development and potential future commercialization or partnership of PRGN-3006, an investigational UltraCAR-T cell therapy targeting acute myeloid leukemia (AML). This program has received Orphan Drug Designation and Fast Track Designation from the FDA, signaling its potential to address an unmet medical need. Enrollment for the Phase 1b trial of PRGN-3006 has been completed, indicating steady progress in its clinical development. Successful progression through trials and potential strategic collaborations could unlock significant revenue streams.

3. Pipeline Development and Strategic Partnerships for UltraCAR-T and AdenoVerse Platforms

   Precigen's broad pipeline, particularly its UltraCAR-T and AdenoVerse immunotherapy platforms, represents a third driver for long-term revenue growth. While PRGN-2012 is the lead asset, other programs like PRGN-2009 for HPV-associated cancers and PRGN-3005 for ovarian cancer are also in various stages of development. The company has indicated a strategy to seek partnerships for some of its CAR-T programs, which could generate revenue through licensing agreements, milestones, and royalties. The inherent flexibility and potential of these proprietary platforms to develop differentiated therapies across immuno-oncology, autoimmune disorders, and infectious diseases position them as ongoing sources of value.

Share Issuance

• Precigen announced its intent to issue over 140 million new shares, as indicated in a September 2025 report.
• In August 2024, the company completed a public offering of 39,878,939 shares of common stock, generating net proceeds of $30.882 million.
• In January 2023, Precigen completed an underwritten public offering of 42,857,143 shares of common stock at $1.75 per share, resulting in gross proceeds of approximately $75.0 million.

Inbound Investments

• In September 2025, Precigen secured up to $125 million in non-dilutive financing through a credit facility agreement with investment funds managed by Pharmakon Advisors, LP, with $100 million funded at closing. These funds are primarily for the U.S. commercialization of PAPZIMEOS and potential international expansion.
• During Q3 2025, Patient Capital Management, LLC increased its holdings in Precigen by 10.2 million shares, representing an estimated transaction value of $28.78 million.
• Around late 2024 or early 2025, Precigen secured $79 million in private placement funding.

Capital Expenditures

• Precigen's capital expenditures decreased in the period leading up to 2020, following the completion of a lab facility expansion in 2019 by PGEN Therapeutics.
• As of March 31, 2025, the company reported $81.0 million in cash, cash equivalents, and investments, with a quarterly cash burn rate of $16.9 million, indicating ongoing operational investments.