8-K
Precigen, Inc. (PGEN)
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):March 25, 2026
PRECIGEN, INC.
(Exact name of registrant as specified in itscharter)
| Virginia | 001-36042 | 26-0084895 |
|---|---|---|
| (State or other jurisdiction<br><br> <br><br><br> <br>of incorporation) | (Commission<br><br> <br>File Number) | (I.R.S. Employer<br><br> <br>Identification No.) |
20374 Seneca Meadows Parkway, Germantown, Maryland20876
(Address of principal executive offices) (Zipcode)
(301) 556-9900
(Registrant’s telephone number, includingarea code)
N/A
(Former name or former address, if changed sincelast report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written communications pursuant to Rule 425 under the Securities<br>Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange<br>Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under<br>the Exchange Act (17 CFR 240.14d-2(b)) |
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| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under<br>the Exchange Act (17 CFR 240.13e-4(c)) |
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Securities registered pursuant to Section 12(b) of the Act:
| Titleof each class | Trading<br><br> <br>Symbol(s) | Name of each exchange<br><br> <br>on which registered |
|---|---|---|
| Common Stock, No Par Value | PGEN | Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. Results of Operations and Financial Condition.
Attached as Exhibit 99.1 is a copy of a press release of Precigen, Inc., dated March 25, 2026, reporting its financial results for the year ended December 31, 2025.
This information, including the Exhibit attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, except as shall be expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit<br><br> <br><br><br> <br>No. | Description |
|---|---|
| 99.1 | Press release dated March 25, 2026 |
| 104 | Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Precigen, Inc. | |
|---|---|
| By: | /s/ Donald P. Lehr |
| Donald P. Lehr | |
| Chief Legal Officer |
Dated: March 25, 2026
Exhibit 99.1
Precigen Reports Full Year 2025 Financial Results and Business Updates
| · | Precigen transitioned to a commercial stagecompany with the US approval of PAPZIMEOS™ (zopapogene imadenovec-drba), the first-and-only FDA-approvedtreatment for adults with RRP, in August 2025 |
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| · | PAPZIMEOS generated $3.4 million in net productrevenue in the fourth quarter of 2025, reflecting the first partial quarter of US commercial sales as payer policies came into effect;the US launch continues to build strong momentum, with a significant increase in demand in the first quarter of 2026 |
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| · | The Centers for Medicare and Medicaid Serviceshas assigned a permanent J-code, J3404, to PAPZIMEOS, effective April 1, 2026, streamlining the claims process and facilitating broaderpatient access |
| --- | --- |
| · | Marketing Authorization Application for PAPZIMEOSfor the treatment of adults with RRP validated by the European Medicines Agency and is under review |
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| · | Open-label redosing study initiated to evaluateretreatment efficacy of zopapogene imadenovec in adults with RRP |
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| · | Expert consensus paper sponsored and publishedby the Recurrent Respiratory Papillomatosis Foundation and authored by 16 leading physicians in the field of RRP recommended PAPZIMEOSas the new standard of care first-line treatment for adults with RRP in the US |
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| · | Cash, cash equivalents, and investments totaled$100.4 million as of December 31, 2025, which is expected to fund the Company’s operations to cash flow break-even |
| --- | --- |
| · | Conference call scheduled for 4:30 PM ET todayto discuss full year 2025 financial results and provide further substantive updates on commercial progress for the first quarter of 2026 |
| --- | --- |
GERMANTOWN, MD, March 25, 2026 – Precigen, Inc. (Nasdaq: PGEN), a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, today announced full year 2025 financial results and business updates.
“With the FDA approval and launch of PAPZIMEOS, 2025 marked a transformational year for Precigen as we transitioned from a clinical-stage to a commercial-stage company and recognized our first commercial product revenues toward the end of the year,” said Helen Sabzevari, PhD, President and CEO of Precigen. “We are seeing strong alignment within the physician community around PAPZIMEOS as the first-line standard of care for adults with RRP, supported by its profile as the only approved therapy for RRP, the compelling safety and efficacy data, and the encouraging durability of response observed to date. This is an exciting time for Precigen, and we look forward to sharing further updates during our call regarding the significant momentum we’re seeing in the first quarter.”
“Commercialization of PAPZIMEOS continues to move rapidly, with growing physician adoption and patient uptake since approval in August. Since deploying our full field organization, we have engaged all target medical institutions and are seeing prescriptions and active treatment across the United States in both major medical centers and community practices. Patient hub enrollment has surpassed 300 patients, reflecting strong demand, while payer coverage now extends to approximately 215 million lives across private insurers, as well as Medicare and Medicaid. The recently published Recurrent Respiratory Papillomatosis Foundation-sponsored expert consensus paper recommending PAPZIMEOS as the first-line standard of care for adults with RRP further reinforces the momentum we are seeing as we continue to see expanded patient access.” said Phil Tennant, Chief Commercial Officer of Precigen.
KEY PROGRAM HIGHLIGHTS
PAPZIMEOS: Establishing a New Standard of Carefor the Treatment of Adults with RRP
| · | PAPZIMEOS full approval with broad label: In August 2025, the FDA granted<br> full approval of PAPZIMEOS with a broad label for the<br> treatment of adults with RRP. |
|---|---|
| · | PAPZIMEOS prescribing, treatment,and distribution: Since full deployment of the PAPZIMEOS field team in September 2025, 100% of target medical institutions have been engaged.PAPZIMEOS is now being prescribed nationwide across both major medical centers and community practices, with patients spanning a rangeof disease severities actively receiving treatment. |
| --- | --- |
| · | Strong patient and physician demand: To<br>date, PAPZIMEOS patient hub enrollment has surpassed 300 registered patients, reflecting substantial patient and physician demand. In<br>addition to these registered patients, a significant number of patients have been identified outside of the PAPZIMEOS hub through the<br>Company’s field engagement efforts. |
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| · | Positive payer coverage: Patient access continuesto expand, with private health plan coverage now estimated at approximately 215 million US lives, including the significant majority ofleading insurers. PAPZIMEOS is also covered under Medicare and Medicaid. Collectively, coverage now extends to approximately 90% of insuredlives in the US. |
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| · | J-code assigned: The Centers for Medicare<br>and Medicaid Services has assigned a permanent J-code, J3404, to PAPZIMEOS, effective April 1, 2026. J-codes are standardized reimbursement<br>codes that allow healthcare providers to |
| --- | --- |
bill government and commercial insurers for physician-administered therapies. Assignment of a permanent J-code streamlines claims processing and will likely facilitate broader patient access.
| · | PAPZIMEOS recommended as new standard of care first-line treatment: In<br> January 2026, an expert consensus paper sponsored<br> and published by the Recurrent Respiratory Papillomatosis Foundation and authored by 16 leading<br> physicians in the field of RRP recommended PAPZIMEOS as the new standard of care first-line<br> treatment for adults with RRP in the US. |
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| · | Compelling long-term clinical and real-world evidence published: At AAO-HNSF 2025, SITC 2025, and<br> EUROGIN 2026, the Company presented long-term<br> durable complete responses with PAPZIMEOS,<br> and at ISPOR Europe 2025, the Company published data demonstrating the substantial<br> healthcare resource utilization and<br> patient-reported<br> quality-of-life burden of RRP,<br> underscoring the disease’s significant clinical, economic, and human impact. |
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| · | Redosing study initiated: The Company initiated an open-label study to evaluate safety, vector<br> shedding, and retreatment efficacy of zopapogene imadenovec in adults with RRP (clinical<br> trial identifier: NCT06538480). |
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| · | MAA under review by the EMA: Following submission in November 2025, the Marketing Authorization<br> Application for PAPZIMEOS for the treatment of adults with RRP was validated by the European<br> Medicines Agency and is under review. PAPZIMEOS was granted orphan<br> drug designation by<br> the European Commission. |
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PRGN-2009 AdenoVerse^®^ Immunotherapy in HPV-associatedcancers
PRGN-2009 is an investigational AdenoVerse immunotherapy designed to activate the immune system to recognize and target HPV-associated cancers.
| · | PRGN-2009 Phase 2 clinical trials under a cooperative<br>research and development agreement (CRADA) with the National Cancer Institute (NCI) in newly diagnosed HPV-associated oropharyngeal cancer<br>are ongoing. |
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| · | PRGN-2009 Phase 2 clinical trial in combination<br>with pembrolizumab in recurrent/metastatic cervical cancer is ongoing. |
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FINANCIAL RESULTS
“2025 was a game-changing year for Precigen with the FDA approval of PAPZIMEOS. We began preparing for the commercial launch of PAPZIMEOS well before the FDA's approval and significantly increased our investment in commercialization efforts as 2025 progressed to support the successful launch of PAPZIMEOS,” said Harry Thomasian Jr., Chief Financial Officer of Precigen. “Our first sale of PAPZIMEOS was recorded in the fourth quarter of 2025 and we are encouraged by continued revenue momentum we’re seeing as we begin the new year. Based upon our present forecast, we expect our current cash position and anticipated cash to be received from PAPZIMEOS sales will fund operations through cash flow break-even by the end of 2026, representing a strong financial foundation as we continue to execute on our commercial and strategic objectives.”
Full Year 2025 Financial Results Compared toPrior Year Period
Total revenues increased by $5.8 million compared to the year ended December 31, 2024. This increase was primarily driven by the commencement of PAPZIMEOS product revenue, which totaled $3.4 million in 2025, reflecting the first partial quarter of US commercial sales following the Company’s commercial launch, as well as higher collaboration and licensing revenue of $1.8 million as a result of the recognition of the remaining deferred revenue associated with the termination of an exclusive channel collaboration agreement.
Research and development expenses decreased by $11.7 million, or 22.1%, compared to the year ended December 31, 2024. The decrease was primarily driven by a $5.4 million reduction in costs associated with ActoBio after the Company closed its operations in 2024. External services also declined by approximately $4.0 million, due to reduced activity for contract research organizations as a result of the strategic prioritization of the Company’s pipeline announced in the third quarter of 2024. In addition, the Company, upon FDA approval of PAPZIMEOS, began classifying manufacturing-related costs to inventory, which ultimately will be recorded as cost of products and services when the related inventory is sold. Manufacturing costs related to PAPZIMEOS were recorded as research and development expenses prior to the FDA approval of PAPZIMEOS.
Selling, General and Administrative (SG&A) expenses increased by $28.8 million, or 69.8%, compared to the year ended December 31, 2024. This increase was primarily due to a $27.3 million increase in costs incurred related to PAPZIMEOS commercial readiness, including sales force expansion, marketing and advertising, as well as professional and other fees associated with the commercial launch of PAPZIMEOS.
In connection with the suspension of ActoBio’s operations in 2024, the Company recorded $34.5 million of impairment charges related to goodwill and long-lived assets in the second quarter of 2024. Additionally, in the second quarter of 2025, the Company recorded $3.9 million of impairment charges related to the Exemplar reporting unit, compared to $5.8 million of impairment charges related to the Exemplar reporting unit in the prior year period.
Total other income (expense), net, decreased from income, net of $7.0 million in 2024 to expense, net of $140.1 million in 2025. This decrease was primarily driven by a $139.5 million increase in the fair value of warrant liabilities prior to their reclassification into permanent equity in the third quarter of 2025. Substantially all of the increase in the fair value of warrant liabilities was as a result of an increase in the Company's common stock price at the valuation date compared to December 31, 2024.
The Company recorded a $179.0 million non-cash deemed dividend on preferred stock in the third quarter of 2025 as a reduction to additional paid-in capital (and an increase in net loss attributable to common shareholders when computing net loss per share) in accordance with US Generally Accepted Accounting Principles (GAAP). On September 15, 2025, all of the outstanding Preferred Shares were converted into common shares.
Net loss attributable to common shareholders was $429.6 million, or $1.37 per basic and diluted share for the year ended December 31, 2025, compared to a net loss of $126.2 million, or $0.47 per basic and diluted share, for the year ended December 31, 2024. The increase in net loss was primarily driven by non-cash items, including the increase in the fair value of the warrant liabilities and the deemed dividend on preferred shares noted above (combined impact of $318.5 million or $1.02 per share).
Precigen: AdvancingMedicine with Precision^®^
Precigen (Nasdaq: PGEN) is a commercial-stage 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. With a strong commitment to innovation, Precigen is developing a robust pipeline of differentiated therapies across its core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. For more information about Precigen, visit www.precigen.com or follow us on LinkedIn or YouTube.
Trademarks
Precigen, PAPZIMEOS, AdenoVerse, and Advancing Medicine with Precision are trademarks of Precigen and/or its affiliates. Other names may be trademarks of their respective owners.
CautionaryStatement Regarding Forward-Looking Statements
Thispress release contains “forward-looking” statements within the meaning of the safe harbor provisions of the US Private SecuritiesLitigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,”“plan,” “goal,” “seek,” “believe,” “project,” “estimate,” “expect,”“strategy,” “future,” “likely,” “may,” “should,” “will” and similarreferences to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differmaterially from what the Company expects. Examples of forward-looking statements include, among others, information relating to the Company’sbusiness and business plans, the success of efforts to commercialize PAPZIMEOS™ (zopapogene imadenovec-drba) for the treatmentof recurrent respiratory papillomatosis (RRP) in adults including the revenue that the Company expects to realize from such efforts,the Company’s ability to successfully obtain foreign regulatory approvals for PAPZIMEOS, expectations about the safety and efficacyof PAPZIMEOS, the ability of PAPZIMEOS to treat RRP, the Company’s future financial and operational results including the Company’sability to reach cash flow break-even, and the Company’s ability to commence clinical studies or complete ongoing clinical studiesfor the Company’s clinical and pre-clinical stage candidates. The Company has no obligation to provide any updates to these forward-lookingstatements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionarystatement. For further information on potential risks and uncertainties, and other important factors, any of which could cause the Company'sactual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors”in the Company’s most recent Annual Report on Form 10-K and subsequent reports filed with the Securities and Exchange Commission.
Investor Contact:
Steven M. Harasym
Tel: +1 (202) 365-2563
investors@precigen.com
Media Contact:
Donelle M. Gregory
press@precigen.com
Precigen, Inc. and Subsidiaries
Consolidated Balance Sheets
(Unaudited)
| (Amounts in thousands) | December 31, 2025 | December 31, 2024 |
|---|---|---|
| Assets | ||
| Current assets | ||
| Cash and cash equivalents | $ 30,234 | $ 29,517 |
| Short-term investments | 67,624 | 68,393 |
| Receivables | ||
| Trade, net | 3,916 | 926 |
| Other | 446 | 237 |
| Inventory | 9,581 | — |
| Prepaid expenses and other | 3,434 | 3,341 |
| Total current assets | 115,235 | 102,414 |
| Long-term investments | 2,511 | — |
| Property, plant and equipment, net | 13,758 | 13,831 |
| Intangible assets, net | 3,182 | 4,455 |
| Goodwill | 15,232 | 19,139 |
| Right-of-use assets | 4,679 | 5,056 |
| Other assets | 908 | 371 |
| Total assets | $ 155,505 | $ 145,266 |
| Liabilities, Mezzanine Equity and Shareholders' Equity | ||
| Current liabilities | ||
| Accounts payable | $ 11,985 | $ 3,531 |
| Accrued compensation and benefits | 10,199 | 8,417 |
| Other accrued liabilities | 10,993 | 4,812 |
| Indemnification accrual | 2,476 | 3,213 |
| Deferred revenue | 517 | 589 |
| Current portion of lease liabilities | 1,136 | 956 |
| Total current liabilities | 37,306 | 21,518 |
| Long-term debt | 93,174 | — |
| Deferred revenue, net of current portion | — | 1,934 |
| Lease liabilities, net of current portion | 3,980 | 4,546 |
| Other long-term liabilities | 134 | — |
| Warrant liabilities | - | 50,537 |
| Total liabilities | 134,594 | 78,535 |
| Mezzanine equity | - | 28,218 |
| Shareholders' equity | ||
| Common stock | - | - |
| Additional paid-in capital | 2,362,252 | 2,129,207 |
| Accumulated deficit | (2,341,348) | (2,090,706) |
| Accumulated other comprehensive income | 7 | 12 |
| Total shareholders' equity | 20,911 | 38,513 |
| Total liabilities, mezzanine equity and shareholders' equity | $ 155,505 | $ 145,266 |
Precigen, Inc. and Subsidiaries
Consolidated Statement of Operations
(Unaudited)
| (Amounts in thousands, except share | Year Ended | |
|---|---|---|
| and per share data) | December 31, 2025 | December 31, 2024 |
| Revenues | ||
| Collaboration and licensing revenue | $ 1,818 | $ - |
| Product revenues, net | 3,975 | 422 |
| Service revenues | 3,891 | 3,503 |
| Total revenues | 9,684 | 3,925 |
| Operating Expenses | ||
| Cost of products and services | 4,823 | 4,267 |
| Research and development | 41,333 | 53,070 |
| Selling, general and administrative | 70,128 | 41,293 |
| Impairment of goodwill | 3,907 | 7,409 |
| Impairment of other noncurrent assets | - | 32,915 |
| Total operating expenses | 120,191 | 138,954 |
| Operating loss | (110,507) | (135,029) |
| Other Income (Expense), Net | ||
| Change in fair value of warrant liabilities | (139,523) | - |
| Interest expense | (3,867) | (6) |
| Interest income | 3,215 | 1,418 |
| Other income, net | 43 | 5,589 |
| Total other (expense) income, net | (140,132) | 7,001 |
| Loss before income taxes | (250,639) | (128,028) |
| Income tax (expense) benefit | (3) | 1,793 |
| Net loss | $ (250,642) | $ (126,235) |
| Deemed dividends on preferred stock | (179,000) | - |
| Net loss attributable to common shareholders | $ (429,642) | $ (126,235) |
| Net Loss per share attributable to common shareholders | ||
| Net loss per share attributable to common shareholders, basic and diluted | $ (1.37) | $ (0.47) |
| Weighted average shares outstanding, basic and diluted | 312,980,562 | 267,727,426 |