# PRECIGEN, INC. (PGEN)

Informational only - not investment advice.

CIK: 0001356090
SIC: 2834 Pharmaceutical Preparations
SIC breadcrumb: [Manufacturing](/division/D/) > [Chemicals And Allied Products](/major-group/28/) > [SIC 2834 Pharmaceutical Preparations](/industry/2834/)
Latest 10-K filed: 2026-03-25
SEC page: https://www.sec.gov/edgar/browse/?CIK=1356090
Filing source: https://www.sec.gov/Archives/edgar/data/1356090/000135609026000009/pgen-20251231.htm

## At a glance

FY2025 · period end 2025-12-31 · filed 2026-03-25 · accession 0001356090-26-000009 · source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001356090.json

| Metric | Value | FY | Provenance |
| --- | ---: | ---: | --- |
| Revenue | 9,684,000 USD | 2025 | verified |
| Net income | -250,642,000 USD | 2025 | verified |
| Assets | 155,505,000 USD | 2025 | verified |
| Free cash flow | -89,826,000 USD | 2025 | computed |
| Revenue YoY | +146.73% | 2025 | computed |

Computed values are grepcent-computed from the verified facts above and may differ from ratios the company itself reports. Free cash flow = operating cash flow − capital expenditures. Revenue YoY = FY2025 revenue ÷ FY2024 revenue − 1 (consecutive fiscal years only).

No market price, no rating, no forecast on this site. Not investment advice.

### Peer percentile fingerprint

| Ratio | PGEN | Peer median | Percentile | N |
| --- | ---: | ---: | ---: | ---: |
| Net margin | -53.3% | 1.0% | 21 | 107 |
| Operating margin | -62.8% | -1.3% | 24 | 100 |
| Revenue growth | 146.7% | 14.7% | 87 | 127 |
| FCF margin | -927.6% | -14.0% | 10 | 127 |
| ROE | -327.8% | -30.7% | 1 | 171 |
| ROA | -161.2% | -21.8% | 1 | 187 |
| Liabilities / equity | 6.44 | 0.38 | 92 | 173 |
| Current ratio | 3.09 | 4.89 | 33 | 188 |

Percentile = share of the N covered peers reporting that ratio whose value is lower (ties counted half); computed among grepcent-covered companies in SIC industry 2834 Pharmaceutical Preparations, not the whole market. A higher percentile means a higher value of the ratio, not a better company. Ratios with fewer than 8 reporting peers are omitted. Latest reported values per company; fiscal periods may differ. Descriptive arithmetic - not a score, rating, or ranking.

## Selected Fundamentals
| Metric | Value | Unit | FY | Filed |
| --- | ---: | --- | ---: | --- |
| Revenue | 9684000 | USD | 2025 | 2026-03-25 |
| Net income | -250642000 | USD | 2025 | 2026-03-25 |
| Assets | 155505000 | USD | 2025 | 2026-03-25 |

## Financials

Annual standardized facts from SEC companyfacts as of latest extracted filing date 2026-03-25. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001356090.json. Derived margins, ratios, and free cash flow are computed from the extracted annual SEC facts.

| Metric | 2012 | 2013 | 2014 | 2015 | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
| --- | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: |
| Revenue |  |  |  |  | 190,926,000 | 219,463,000 | 151,178,000 | 90,722,000 | 31,992,000 | 14,267,000 |  | 6,225,000 | 3,925,000 | 9,684,000 |
| Net income |  |  |  |  | -186,612,000 | -117,018,000 | -509,336,000 | -322,324,000 | -170,521,000 | -92,166,000 | 28,317,000 | -95,904,000 | -126,235,000 | -250,642,000 |
| Operating income | -75,157,000 | -58,023,000 | -69,962,000 | -146,864,000 | -125,166,000 | -137,890,000 | -505,610,000 |  |  |  |  | -99,758,000 | -135,029,000 | -110,507,000 |
| Diluted EPS |  |  |  |  |  |  |  | -2.09 | -1.02 | -0.47 | 0.14 | -0.39 | -0.47 | -1.37 |
| Operating cash flow |  |  |  |  | -48,988,000 | -103,720,000 | -124,240,000 | -135,927,000 | -77,021,000 | -55,771,000 | -65,045,000 | -66,930,000 | -68,173,000 | -87,831,000 |
| Capital expenditures |  |  |  |  | 31,629,000 | 46,666,000 | 41,587,000 | 37,883,000 | 7,527,000 | 7,247,000 | 4,924,000 | 1,536,000 | 8,584,000 | 1,995,000 |
| Assets |  |  |  |  | 949,068,000 | 846,851,000 | 716,177,000 | 455,763,000 | 314,587,000 | 359,856,000 | 215,977,000 | 151,043,000 | 145,266,000 | 155,505,000 |
| Liabilities |  |  |  |  | 379,820,000 | 300,306,000 | 337,455,000 | 384,052,000 | 247,413,000 | 252,508,000 | 89,718,000 | 32,545,000 | 78,535,000 | 134,594,000 |
| Stockholders' equity |  |  |  |  | 560,237,000 | 533,631,000 | 362,855,000 | 71,711,000 | 67,174,000 | 107,348,000 | 126,259,000 | 118,498,000 | 38,513,000 | 20,911,000 |
| Cash and cash equivalents |  |  |  |  | 62,607,000 | 68,111,000 | 96,876,000 | 65,793,000 | 51,792,000 | 36,423,000 | 4,858,000 | 7,578,000 | 29,517,000 | 30,234,000 |
| Free cash flow |  |  |  |  | -80,617,000 | -150,386,000 | -165,827,000 | -173,810,000 | -84,548,000 | -63,018,000 | -69,969,000 | -68,466,000 | -76,757,000 | -89,826,000 |

### Ratios

ROE and ROA use period-end equity/assets. Liabilities / equity uses total liabilities divided by stockholders' equity. Current ratio uses current assets divided by current liabilities when both are reported.

| Metric | 2012 | 2013 | 2014 | 2015 | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
| --- | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: |
| Net margin |  |  |  |  | -97.74% | -53.32% |  |  |  |  |  |  |  |  |
| Operating margin |  |  |  |  | -65.56% | -62.83% |  |  |  |  |  |  |  |  |
| Return on equity |  |  |  |  | -33.31% | -21.93% | -140.37% | -449.48% | -253.85% | -85.86% | 22.43% | -80.93% | -327.77% |  |
| Return on assets |  |  |  |  | -19.66% | -13.82% | -71.12% | -70.72% | -54.20% | -25.61% | 13.11% | -63.49% | -86.90% | -161.18% |
| Liabilities / equity |  |  |  |  | 0.68 | 0.56 | 0.93 | 5.36 | 3.68 | 2.35 | 0.71 | 0.27 | 2.04 | 6.44 |
| Current ratio |  |  |  |  | 3.33 | 1.92 | 4.64 | 1.91 | 3.54 | 4.52 | 1.50 | 2.99 | 4.76 | 3.09 |

## As-reported value updates

7 tracked differences above grepcent's stated thresholds were found between the earliest XBRL-filed value and the value currently on file for the same fiscal period.

Ledger: /company/PGEN/revisions/


## Quarterly

Quarterly standardized facts from SEC companyfacts as of latest extracted filing date 2026-08-04. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001356090.json.

Flow metrics use discrete quarter-length periods from 10-Q/10-Q/A filings. Q4 revenue and net income are derived only when annual FY and nine-month YTD facts exist for the same fiscal year; derived Q4 values are labeled. EPS Q4 is not derived.

| Quarter | End date | Revenue | Net income | Diluted EPS | Method |
| --- | --- | ---: | ---: | ---: | --- |
| 2021-Q1 | 2021-03-31 | 24,511,000 |  |  | reported discrete quarter |
| 2021-Q2 | 2021-06-30 | 33,580,000 |  |  | reported discrete quarter |
| 2021-Q3 | 2021-09-30 | 21,561,000 |  |  | reported discrete quarter |
| 2021-Q4 | 2021-12-31 | 24,221,000 |  |  | derived Q4 = FY annual - nine-month YTD |
| 2022-Q1 | 2022-03-31 | 32,021,000 |  |  | reported discrete quarter |
| 2022-Q2 | 2022-06-30 | 2,911,000 |  |  | reported discrete quarter |
| 2022-Q3 | 2022-09-30 | 16,722,000 |  | 0.44 | reported discrete quarter |
| 2022-Q4 | 2022-12-31 | 1,763,000 |  |  | derived Q4 = FY annual - nine-month YTD |
| 2023-Q1 | 2023-03-31 | 1,851,000 |  | -0.10 | reported discrete quarter |
| 2023-Q2 | 2023-06-30 | 1,767,000 |  | -0.08 | reported discrete quarter |
| 2023-Q3 | 2023-09-30 |  | -19,795,000 | -0.08 | reported discrete quarter |
| 2023-Q4 | 2023-12-31 |  | -33,056,000 |  | derived Q4 = FY annual - nine-month YTD |
| 2024-Q1 | 2024-03-31 |  | -23,738,000 | -0.10 | reported discrete quarter |
| 2024-Q2 | 2024-06-30 |  | -58,792,000 | -0.23 | reported discrete quarter |
| 2024-Q3 | 2024-09-30 |  | -23,978,000 | -0.09 | reported discrete quarter |
| 2024-Q4 | 2024-12-31 |  | -19,727,000 |  | derived Q4 = FY annual - nine-month YTD |
| 2025-Q1 | 2025-03-31 |  | -54,153,000 | -0.18 | reported discrete quarter |
| 2025-Q2 | 2025-06-30 |  | -26,642,000 | -0.09 | reported discrete quarter |
| 2025-Q3 | 2025-09-30 |  | -146,344,000 | -1.06 | reported discrete quarter |
| 2025-Q4 | 2025-12-31 |  | -23,503,000 |  | derived Q4 = FY annual - nine-month YTD |
| 2026-Q1 | 2026-03-31 | 23,252,000 | -7,929,000 | -0.02 | reported discrete quarter |
| 2026-Q2 | 2026-06-30 | 54,978,000 | 20,071,000 | 0.05 | reported discrete quarter |

## Filed narrative (10-K & 10-Q)

## Business

Verbatim Item 1 Business section from PGEN's latest 10-K: [/company/PGEN/business/](/company/PGEN/business/).

## Risk Factors

Verbatim Item 1A Risk Factors from PGEN's latest 10-K: [/company/PGEN/risk-factors/](/company/PGEN/risk-factors/).

## Latest quarter (10-Q)

Latest 10-Q source: https://www.sec.gov/Archives/edgar/data/1356090/000135609026000030/pgen-20260630.htm

Extracted structurally from real Item 2 body heading to real Item 3/4 boundary. Published MD&A gate trimmed front/tail over-capture.
Confidence: high
Filing date: 2026-08-04
Report date: 2026-06-30

Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations

The following "Management's Discussion and Analysis of Financial Condition and Results of Operations" should be read in conjunction with the unaudited financial information and the notes thereto included in this Quarterly Report on Form 10-Q, or Quarterly Report, and our Annual Report on Form 10-K for the year ended December 31, 2025, or Annual Report.

The following discussion contains forward-looking statements that reflect our plans, estimates, expectations, and beliefs. Our actual results could differ materially from those discussed in the forward-looking statements and you are cautioned not to place undue reliance on forward-looking statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Quarterly Report, particularly in "Special Note Regarding Forward-Looking Statements" and "Risk Factors." The forward-looking statements included in this Quarterly Report are made only as of the date hereof.

Overview

We are a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients. We are leveraging our proprietary technology platforms to develop product candidates designed to target urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases.

We believe that our array of technology platforms uniquely positions us among other biotechnology companies to advance precision medicine. Our proprietary and complementary technology platforms provide a strong foundation to realize the core promise of precision medicine by supporting our efforts to construct powerful gene programs to drive efficacy, deliver these programs through viral, non-viral, and microbe-based approaches to drive lower costs, and control gene expression to drive safety. Our therapeutic platforms, including AdenoVerse immunotherapy, UltraCAR-T, and ActoBiotics, are designed to allow us to precisely control the level and physiological location of gene expression and modify biological molecules to control the function and output of living cells to treat underlying disease conditions. We have developed a proprietary electroporation device, UltraPorator, designed to further streamline and ensure the rapid and cost-effective manufacturing of UltraCAR-T therapies.

Our commercial product, Papzimeos (zopapogene imadenovec-drba, PRGN-2012), is the first and only U.S. Food and Drug Administration (“FDA”) approved therapy for the treatment of adults with recurrent respiratory papillomatosis (“RRP”). RRP is a rare, debilitating, and potentially life-threatening disease caused by chronic human papillomavirus (HPV) 6 or HPV 11 infection, which results in recurrent benign tumors in the respiratory tract. Papzimeos is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen comprising selected regions of HPV types 6 and 11 proteins. Papzimeos is designed to generate an immune response directed against HPV 6 and HPV 11 proteins in patients with RRP.

Our clinical pipeline includes PRGN-2009, which is based on our AdenoVerse immunotherapy platform; and PRGN-3005, PRGN-3006 and PRGN-3007, which are built on our UltraCAR-T platform. We have completed enrollment in the Phase 1b clinical trial of PRGN-3006. As part of the strategic prioritization of our pipeline announced in August 2024, we paused enrollment in the PRGN-3005 and PRGN-3007 clinical trials.

Precigen

We are developing therapies built on our AdenoVerse immunotherapy platform and our UltraCAR-T therapeutics platform. Our AdenoVerse immunotherapy platform utilizes a library of proprietary adenovectors for the efficient gene delivery of therapeutic effectors, immunomodulators, and vaccine antigens. We have established proprietary manufacturing cell lines and production methodologies from our AdenoVerse immunotherapy platform, which we believe are scalable for commercial supply. We believe that our proprietary gorilla adenovectors, part of the AdenoVerse technology, have superior performance characteristics as compared to current competition, including standard human adenovirus serotype 5, rare human adenovirus types and other non-human primate adenovirus types.

In August 2025, the FDA granted full approval to Papzimeos for the treatment of adults with RRP. The Papzimeos approval marked a historic milestone for the RRP patient community as the first FDA-approved therapy for the treatment of adults with RRP. We completed submission of the rolling Biologics License Application (BLA) in December 2024 under an accelerated approval pathway; however, the FDA has granted Papzimeos full approval. As a result of Papzimeos receiving full FDA approval, a confirmatory clinical trial is no longer required.

Papzimeos is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen comprising selected regions of HPV types 6 and 11 proteins. Papzimeos is delivered via four subcutaneous injections over a 12-week

31

Table of Contents

interval. Papzimeos approval is supported by safety and efficacy data from the pivotal Phase 1/2 clinical trial published in the Lancet Respiratory Medicine. The pivotal study successfully met its primary safety and pre-specified primary efficacy endpoints. Papzimeos was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2. 51% (18 out of 35) of study patients achieved Complete Response, requiring no surgeries in the 12 months after treatment with Papzimeos. Complete Responses remained durable for over 12 months. Fifteen out of 18 (83%) complete responders demonstrated ongoing complete responses after their Papzimeos treatment for at least 36 months with median follow-up of 36 months (range: 36 to 51 months) as of the April 30, 2026 data cutoff.

Following the FDA approval, we launched Papzimeos in the United States as the first and only FDA approved treatment for adults with RRP. We estimate that there are approximately 27,000 adult patients in the United States living with RRP.

Papzimeos had been granted Breakthrough Therapy Designation and Orphan Drug designation for the treatment of RRP by the FDA. In May 2026, the FDA granted a seven-year period of orphan drug exclusivity for Papzimeos for the treatment of adults with RRP through August 14, 2032. In addition, zopapogene imadenovec has received Orphan Drug Designation for the Treatment of RRP from the European Commission as well. We submitted a Marketing Authorization Application (“MAA”) for zopapogene imadenovec for the treatment of adults with RRP to the European Medicines Agency (“EMA”). The MAA has been validated by the EMA and is currently under review.

PRGN-2009, an investigational non-replicating adenoviral vector-based immunotherapy, based on our AdenoVerse platform, is designed to activate the immune system to recognize and target human papillomavirus-positive, or HPV+, solid tumors. PRGN-2009 leverages our UltraVector and AdenoVerse platforms to optimize HPV type 16 and HPV type 18, antigen designed for delivery via a proprietary gorilla adenovector with a large genetic payload capacity and the ability for repeat administrations. Guided by our bioinformatics analysis and in silico protein engineering, PRGN-2009 encodes for a novel, multi-epitope antigen design to target HPV16 and HPV18 infected cells and potentially differentiates from the competition.

PRGN-2009 is being evaluated in two Phase 2 clinical trials for patients with newly-diagnosed HPV-associated oropharyngeal cancer in collaboration with NCI pursuant to a CRADA. The first Phase 2 clinical trial is designed to evaluate PRGN-2009 in combination with anti-PD1 antibody, pembrolizumab, in adult patients with newly-diagnosed HPV-associated oropharyngeal cancer. The second Phase 2 clinical trial is designed to evaluate PRGN-2009 in combination with neoadjuvant chemotherapy in adult patients with newly-diagnosed HPV-associated oropharyngeal cancer. PRGN-2009 is also being evaluated in a multicenter Phase 2 clinical trial to evaluate efficacy and safety of PRGN-2009 in combination with pembrolizumab in patients with recurrent or metastatic cervical cancer.

Through our UltraCAR-T therapeutics platform, we are able to precision-engineer UltraCAR-T cells to produce a homogeneous cell product that simultaneously expresses antigen-specific chimeric antigen receptor, or CAR, kill switch, and our proprietary membrane-bound interleukin-15, or mbIL15, genes in any genetically modified UltraCAR-T cell. Our decentralized and rapid proprietary manufacturing process allows us to manufacture UltraCAR-T cells overnight at a medical center's current good manufacturing practices facility and reinfuse the patient the following day after gene transfer. This process improves upon current approaches to CAR-T manufacturing, which require extensive ex vivo expansion following viral vector transduction to achieve clinically relevant cell numbers that we believe can result in the exhaustion of CAR-T cells prior to their administration, limiting their potential for persistence in patients. We have developed a proprietary electroporation device, UltraPorator, designed to further streamline and ensure the rapid and cost-effective manufacturing of UltraCAR-T therapies. The UltraPorator system includes proprietary hardware and software solutions and potentially represents a major advancement over current electroporation devices by significantly reducing the processing time and contamination risk. UltraPorator is intended to be a viable scale-up and commercialization solution for decentralized UltraCAR-T manufacturing.

PRGN-3006 is an investigational autologous CAR-T therapy that utilizes our UltraCAR-T platform to express a CAR to target CD33 (Siglec-3), mbIL15 and a kill switch gene. PRGN-3006 is in a Phase 1/1b clinical trial for the treatment of relapsed or refractory, or r/r, acute myeloid leukemia, or AML, and high-risk myelodysplastic syndromes, or MDS. PRGN-3006 has been granted Fast Track designation in patients with r/r AML by the FDA. Previously PRGN-3006 was granted Orphan Drug Designation in patients with AML by the FDA. We have completed the Phase 1 dose escalation trial. We have completed enrollment of the Phase 1b trial for PRGN-3006 in AML. We plan to focus on strategic partnership opportunities to advance PRGN-3006 UltraCAR-T program in AML.

PRGN-3005 is an investigational autologous CAR-T therapy that utilizes our UltraCAR-T platform to simultaneously express a CAR targeting the unshed portion of the Mucin 16 antigen, mbIL15, and kill switch genes. PRGN-3005 is in a Phase 1/1b clinical trial for the treatment of advanced, recurrent platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer. We have completed the Phase 1 dose escalation portion of the PRGN-3005 Phase 1/1b study. As part of the strategic

32

Table of Contents

prioritization of our pipeline announced in August 2024, we have paused enrollment in the Phase 1b clinical trial of PRGN-3005.

PRGN-3007 is an investigational autologous CAR-T therapy that utilizes the next generation UltraCAR-T platform to express a CAR which targets ROR1, mbIL15, a kill switch, and a novel mechanism for the intrinsic blockade of the programmed death 1, or PD-1, gene expression. PRGN-3007 is in a Phase 1/1b clinical trial for patients with advanced receptor tyrosine kinase-like orphan receptor 1-positive, or ROR1+, hematological (Arm 1) and solid tumors (Arm 2). The target patient population for Arm 1 includes relapsed or refractory CLL, relapsed or refractory MCL, relapsed or refractory B-ALL, and relapsed or refractory DLBCL. The target patient population for Arm 2 includes locally advanced unresectable or metastatic histologically confirmed TNBC. As part of t

[Excerpt truncated for page length; source filing is linked above.]

## Latest 10-K MD&A (excerpt)

Latest 10-K Item 7 source: https://www.sec.gov/Archives/edgar/data/1356090/000135609026000009/pgen-20251231.htm
Complete FY 2025 MD&A: /company/PGEN/mda/fy2025/

Extracted structurally from real Item 7 body heading to real Item 7A/8 boundary. Published MD&A gate trimmed front/tail over-capture.
Confidence: high
Filing date: 2026-03-25
Report date: 2025-12-31

Item 7.    Management's Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis of financial condition and results of operations is provided to enhance the understanding of, and should be read in conjunction with, Part I, Item 1, "Business" and Item 8, "Financial Statements and Supplementary Data." For information on risks and uncertainties related to our business that may make past performance not indicative of future results, or cause actual results to differ materially from any forward-looking statements, see "Special Note Regarding Forward-Looking Statements," and Part I, Item 1A, "Risk Factors." Refer to Item 7: Management’s Discussion and Analysis of Financial Condition and Results of Operations in our 2024 Annual Report on Form 10-K for management’s discussion and analysis of financial condition and results of operations for the fiscal year 2024 compared to fiscal year 2023.

Overview

We are a biopharmaceutical company specializing in the advancement of innovative precision medicines to address difficult-to-treat diseases with high unmet patient need. Precigen is dedicated to advancing scientific breakthroughs from proof-of-concept through commercialization. We are leveraging our proprietary technology platforms to develop product candidates designed to target urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases.

We believe that our array of technology platforms uniquely positions us among other biotechnology companies to advance precision medicine. Our proprietary and complementary technology platforms provide a strong foundation to realize the core promise of precision medicine by supporting our efforts to construct powerful gene programs to drive efficacy, deliver these programs through viral, non-viral, and microbe-based approaches to drive lower costs, and control gene expression to drive safety. Our therapeutic platforms, including AdenoVerse immunotherapy, UltraCAR-T, and ActoBiotics, are designed to allow us to precisely control the level and physiological location of gene expression and modify biological molecules to control the function and output of living cells to treat underlying disease conditions. We have developed a proprietary electroporation device, UltraPorator, designed to further streamline and ensure the rapid and cost-effective manufacturing of UltraCAR-T therapies.

Our commercial product, Papzimeos (zopapogene imadenovec-drba, PRGN-2012), is the first and only US Food and Drug Administration (“FDA”) approved therapy for the treatment of adults with recurrent respiratory papillomatosis (“RRP”). Papzimeos is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen comprising selected regions of human papillomavirus (HPV) types 6 and 11 proteins. Papzimeos is designed to generate an immune response directed against HPV 6 and HPV 11 proteins in patients with RRP. Discovered and designed in Precigen's labs using Precigen's proprietary AdenoVerse therapeutic platform, Papzimeos represents a new therapeutic paradigm for RRP.

Our clinical pipeline includes PRGN-2009, which are based on our AdenoVerse immunotherapy platform; and PRGN-3005, PRGN-3006 and PRGN-3007, which are built on our UltraCAR-T platform. We have completed enrollment in the Phase 1b clinical trial of PRGN-3006. As part of the strategic prioritization of our pipeline announced in August 2024, we paused enrollment in the PRGN-3005 and PRGN-3007 clinical trials, minimized UltraCAR-T spending and plan to focus on strategic

73

Table of Contents

partnerships to further advance UltraCAR-T programs. In addition, we previously announced plans to continue PRGN-2009 Phase 2 clinical trials under a cooperative research and development agreement ("CRADA") with the National Cancer Institute ("NCI") in recurrent/metastatic cervical cancer and in newly diagnosed HPV-associated oropharyngeal cancer.

Fiscal Year 2025 Business Update

In August 2025, the U.S. Food and Drug Administration ("FDA") granted full approval of Papzimeos for the treatment of adults with RRP. RRP is a rare, debilitating, and potentially life-threatening disease caused by chronic human papillomavirus ("HPV") 6 or HPV 11 infection, which results in recurrent benign tumors in the respiratory tract. RRP can lead to severe voice disturbance, a compromised airway, and recurrent post-obstructive pneumonias. Management of RRP has primarily consisted of repeated surgeries, which do not address the root cause of the disease and can be associated with significant morbidity as well as significant patient and health system burden. The approval of Papzimeos marks a historic milestone for the RRP patient community as the first and only FDA-approved therapy for the treatment of adults with RRP. As a result of Papzimeos receiving full FDA approval, a confirmatory clinical trial is not required.

Papzimeos is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen comprising selected regions of HPV types 6 and 11 proteins—the root cause of RRP. Papzimeos is delivered via four subcutaneous injections over a 12-week interval. Papzimeos approval is supported by safety and efficacy data from the pivotal Phase 1/2 clinical trial published in the Lancet Respiratory Medicine. The pivotal study successfully met its primary safety and pre-specified primary efficacy endpoints. Papzimeos was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2. Of the patients in our study, 51% (18 out of 35) achieved complete response, requiring no surgeries in the 12 months after treatment with Papzimeos. These complete responses have been durable after Papzimeos treatment with median follow-up of 36 months as of a September 19, 2025 data cutoff.

See further discussion of 2025 financing transactions below under the Liquidity and capital resources section of Item 7.

Financial operations overview

Sources of revenue

Exemplar generates product and service revenues through the development and sale of genetically engineered miniature swine models. We recognize revenue when control of the promised product or service is transferred to the customer. In 2025, revenues generated by Exemplar became less significant to the Company, and we expect this significance to greatly diminish into the future.

During the fourth quarter of 2025, we began generating revenue from commercial sales of Papzimeos, our FDA‑approved immunotherapy for RRP. While revenues from Papzimeos were limited in the year due to the timing of our commercial launch, we anticipate our future revenue to primarily be generated from Papzimeos product sales.

As we transition to a commercial‑stage company, our future revenues will increasingly depend on our ability to successfully commercialize Papzimeos, advance our proprietary programs, and bring additional products enabled by our technology platforms to market.

We anticipate that collaboration revenue will remain minimal in the near term, except in cases of future strategic transactions involving our platforms or programs. Should new collaboration agreements or strategic transactions be executed, revenue could be positively impacted.

Accordingly, there can be no assurance as to the timing, magnitude, and predictability of revenues, if any, to which we might be entitled.

Cost of products and services and gross margin

Cost of products and services consists of manufacturing costs, transportation and freight-in, and indirect overhead costs (including salary and benefits related and stock-based compensation expenses) associated with the commercial manufacturing and distribution of Papzimeos, and costs related to our Exemplar business, which includes primarily labor, supplies, feed used in production, and facility charges. Approximately $4.4 million of our cost of products and services in 2025 relates to our Exemplar business.

74

Table of Contents

For the year ended December 31, 2025, the cost of products and services includes the costs of Papzimeos sales. Prior to August 14, 2025, regulatory approval and subsequent commercialization of Papzimeos and thus the possibility of future economic benefits from Papzimeos sales were not considered probable and inventory-related costs were expensed as incurred. As such, the inventory recognized on the Consolidated Balance Sheet at December 31, 2025 does not include any costs incurred prior to August 14, 2025, which is referred to as pre-launch inventory. In addition, the cost of products related to Papzimeos on the Consolidated Statement of Operations for the year ended December 31, 2025 is comprised of the sale of pre-launch inventory, which only includes costs incurred subsequent to August 14, 2025, including period costs that were not absorbed into inventory. As of December 31, 2025, the amount of future estimated net revenues represented by existing physical pre-launch inventories is approximately $85 million based on our current pricing assumptions and projected demand for our recently approved commercial product. Due to the fact that commercialization began in late 2025, these estimates are inherently subject to significant uncertainty.

The Company expects that it will finish selling all of the pre-launch inventories in 2026. Projected sales derived from pre-launch inventories depend on several factors that could materially impact actual realized results, including the timing and scale of product adoption within our target patient population, and payer coverage. As a result, the cost of products sold related to Papzimeos will initially reflect a lower average per unit cost of materials (excluding period costs that are expensed as incurred), as pre-launch inventory is utilized for commercial production and sold to customers. As pre-launch inventory continues to absorb costs through the manufacturing process, we expect the current gross margins (exclusive of period costs expensed as incurred) will gradually decrease as pre-launch inventory is sold and will stabilize between high 80 percentages and low 90 percentages when pre-launch inventories are expected to be completely sold based on current forecasts, which include significant risks given that Papzimeos is the first therapy available to patients with RRP.

Research and development expenses

We recognize research and development expenses as they are incurred. Our research and development expenses consist primarily of:

•salaries and benefits, including stock-based compensation expense, as well as severance costs related to personnel in research and development functions, if such costs exist;

•fees paid to consultants and contract research organizations who perform research on our behalf and under our direction;

•costs related to laboratory supplies used in our research and development efforts and acquiring, developing, and manufacturing preclinical study and clinical trial materials;

•costs related to certain in-licensed technology rights or reacquired in-process research and development;

•amortization of patents and related technologies acquired in mergers and acquisitions;

•facility-related expenses, which include direct depreciation costs and unallocated expenses for rent and maintenance of facilities and other operating costs; and

•other manufacturing costs related to the manufacture of drug products that have not yet been approved by the FDA.

Our research and development expenses primarily relate to either costs incurred to expand or otherwise improve our technologies or the costs incurred to develop our own products and services. Prior to August 2024, the Company was progressing preclinical and clinical programs that targeted urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases, including PRGN-3005, PRGN-3006, P

[Excerpt truncated for page length; the complete text is on the linked full-MD&A page.]

Read the full FY 2025 MD&A: /company/PGEN/mda/fy2025/
All MD&A years: /company/PGEN/mda/


## MD&A history

Prior-year 10-K MD&A spans are extracted from SEC filings with the same bounded parser used for the latest filing. Each year's full verbatim text is on its own sub-page.

- [FY 2024 MD&A](/company/PGEN/mda/fy2024/): filed 2025-03-19; accession 0001356090-25-000007 (https://www.sec.gov/Archives/edgar/data/1356090/000135609025000007/pgen-20241231.htm)
- [FY 2023 MD&A](/company/PGEN/mda/fy2023/): filed 2024-03-19; accession 0001356090-24-000007 (https://www.sec.gov/Archives/edgar/data/1356090/000135609024000007/pgen-20231231.htm)
- [FY 2022 MD&A](/company/PGEN/mda/fy2022/): filed 2023-03-06; accession 0001356090-23-000004 (https://www.sec.gov/Archives/edgar/data/1356090/000135609023000004/pgen-20221231.htm)
- [FY 2021 MD&A](/company/PGEN/mda/fy2021/): filed 2022-03-01; accession 0001356090-22-000002 (https://www.sec.gov/Archives/edgar/data/1356090/000135609022000002/pgen-20211231.htm)


## FDA-approved drug applications

Applications listed under this company's exact-matched sponsor name. Approved applications only.

No resolved FDA applications were found for this company under the exact-unique, approved-only publish rule.

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

This list covers FDA applications whose listed sponsor name maps to this company by an exact-unique match; applications listed under sponsor names not mapped to this company (subsidiaries, name variants, joint ventures) are absent.


## Macro cross-references

Indicators mapped to this company's SIC classification (industry 2834 Pharmaceutical Preparations) by grepcent's deterministic macro-sector crosswalk. A navigational mapping, not a statistical or causal claim.

- [INDPRO](/indicator/INDPRO/): Industrial Production: Total Index
- [TCU](/indicator/TCU/): Capacity Utilization: Total Index
- [PPIACO](/indicator/PPIACO/): Producer Price Index by Commodity: All Commodities
- [GDPC1](/indicator/GDPC1/): Real Gross Domestic Product
- [DGS10](/indicator/DGS10/): Market Yield on U.S. Treasury Securities at 10-Year Constant Maturity
- [FEDFUNDS](/indicator/FEDFUNDS/): Federal Funds Effective Rate
- [CES0500000003](/indicator/CES0500000003/): Average Hourly Earnings of All Employees, Total Private
- [PAYEMS](/indicator/PAYEMS/): All Employees, Total Nonfarm

Macro-to-micro threads including this sector: [Inflation (CPI / PCE / PPI)](/thread/inflation-cpi-pce-ppi/), [US labor market](/thread/us-labor-market/), [Growth & output](/thread/growth-output/), [Money & trade](/thread/money-trade/), [Government finances](/thread/government-finances/), [Sector employment](/thread/sector-employment/), [Industrial orders & inventories](/thread/industrial-orders/), [Trade & external](/thread/trade-external/).

All macro indicators: /indicators/


## For LLMs & downloads

Markdown twin: /company/PGEN.md · JSON record: /company/PGEN.json · verified financials: /company/PGEN/financials.json / /company/PGEN/financials.csv · machine TOC for the whole site: /llms.txt