Form 8-K

8-K — PRECIGEN, INC.

Accession: 0000950103-26-007158

Filed: 2026-05-13

Period: 2026-05-13

CIK: 0001356090

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — dp246650_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (dp246650_ex9901.htm)

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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):

May 13, 2026

PRECIGEN, INC.

(Exact name of registrant as specified in its

charter)

Virginia

001-36042

26-0084895

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(I.R.S. Employer

Identification No.)

20374 Seneca Meadows Parkway, Germantown, Maryland 20876

(Address of principal executive offices) (Zip code)

(301) 556-9900

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last 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

Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange

Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under

the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under

the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading

Symbol(s)

Name of each exchange 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 May 13, 2026, reporting its financial results for the quarter ended March 31, 2026.

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

No.

Description

99.1

Press release dated May 13, 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: May 13, 2026

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: dp246650_ex9901.htm · Sequence: 2

Exhibit 99.1

Precigen Reports First Quarter 2026 Financial Results and Business

Updates

· PAPZIMEOS™ launch gaining

strong momentum with $21.6 million in net product revenue in the first quarter of 2026 reflecting broad-based uptake across the US

· Patient hub enrollment continues to gain traction,

with approximately 400 patients currently enrolled; a notable 25% of which are from the community setting, underscoring the breadth of

PAPZIMEOS's reach and ease of administration

· Updated durability of response data for PAPZIMEOS

will be presented at the upcoming ASCO Annual Meeting

· RRP Awareness Day will be hosted alongside

the Recurrent Respiratory Papillomatosis Foundation on June 11 for the third consecutive year, reflecting the Company’s ongoing

commitment to the recurrent respiratory papillomatosis (RRP) community

· The Company continues to advance PRGN-2009

in HPV-associated cancers and plans to provide an AdenoVerse® pipeline update by end of year

· Cash, cash equivalents, and investments totaled

$56.7 million as of March 31, 2026, which together with the anticipated proceeds from PAPZIMEOS revenue, is expected to fund the

Company’s operations to cash flow break-even by the end of 2026

· Conference call scheduled

for 4:30 PM ET today

GERMANTOWN, MD, May 13, 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 first quarter 2026 financial results and business updates.

“We are thrilled with the strength of the

PAPZIMEOS launch and the pace of revenue growth as we drive broad commercial success across the US and work toward expanded market opportunities

in additional geographies and the pediatric patient population,” said Helen Sabzevari, PhD, President and CEO of Precigen. “Looking

ahead, we are excited to advance the next chapter of our AdenoVerse platform through the continued development of PRGN-2009 in HPV-associated

cancers, and look forward to sharing more details on our broader pipeline progress later this year. We are also proud to once again collaborate

with the Recurrent Respiratory Papillomatosis Foundation in recognizing RRP Awareness Day for the third consecutive year on June 11, reflecting

our deep and long-standing commitment to the RRP community. This year's event carries particular significance as adult patients now have

access to an approved treatment, PAPZIMEOS, for the first time in the more than 100-year history of this disease.”

“We are encouraged by the strong progress

we are seeing as PAPZIMEOS continues to gain traction, with approximately 400 patients currently enrolled in the PAPZIMEOS patient hub,

of which a noteworthy 25% are from the community setting,” said Phil Tennant, Chief Commercial Officer of Precigen. “We are

focused on converting hub enrollment into treated patients, and we look forward to building on this progress in the second quarter and

beyond as more sites become activated, the impact of the permanent J-code takes hold, and our targeted site support helps deliver a seamless

journey to treatment.”

KEY PROGRAM HIGHLIGHTS

PAPZIMEOS™: First-line

Standard of Care for the Treatment of Adults with RRP

PAPZIMEOS (zopapogene imadenovec-drba) is a non-replicating

adenoviral vector-based immunotherapy designed to generate an immune response directed against HPV 6 and HPV 11 proteins in patients

with RRP. In August 2025, the US Food and Drug Administration (FDA) granted full approval of PAPZIMEOS

with a broad label for the treatment of adults with RRP. PAPZIMEOS is the first and only FDA-approved therapy for the treatment of adults

with RRP and the first treatment that addresses the root cause of RRP.

· National prescribing growth: PAPZIMEOS

is being prescribed nationwide across both major medical centers and community practices, with patients spanning a range of disease severities

actively receiving treatment. Building on strong community practice demand, the Company’s target footprint has been expanded beyond

the initial list, with increased engagement across community practices reflecting the broad interest seen since the full deployment of

the PAPZIMEOS field team in September 2025.

· Patient hub enrollment: Enrollment in Precigen’s

patient hub reached approximately 400 registered patients, reflecting robust and growing demand from both patients and physicians. Notably,

25% of hub-enrolled patients are from the community setting, underscoring the broad reach of PAPZIMEOS beyond academic and major centers

and reinforcing that PAPZIMEOS can be effectively integrated into routine clinical practice beyond major centers. Beyond hub enrollment,

the Company's field teams continue to identify additional patients outside the hub, further underscoring the breadth of unmet need and

commercial opportunity in the RRP community.

· Positive

payer coverage: PAPZIMEOS has private health plan coverage spanning approximately 215

million US lives, including the significant majority of leading insurers. With additional

coverage under Medicare and Medicaid,

PAPZIMEOS is accessible to an estimated

297 million US lives, or over 90% of insured lives in the US, reflecting broad and growing payer support for the therapy.

· Permanent J-code accelerating site activations

and patient access: Effective April 1, 2026, the Centers for Medicare and Medicaid Services assigned a permanent J-code (J3404) to

PAPZIMEOS, and early indicators suggest this is already streamlining site activations. J-codes are standardized reimbursement codes that

enable healthcare providers to bill government and commercial insurers for physician-administered therapies, and the permanent J-code

designation is expected to further simplify claims processing and facilitate broader patient access across both medical centers and community

practices.

· PAPZIMEOS

recommended as standard of care first-line treatment: In

January 2026, an expert position paper sponsored

and published by the Recurrent Respiratory Papillomatosis Foundation and authored by 16 leading

physicians in the field of RRP recommended PAPZIMEOS as the new standard of care first-line

treatment for adults with RRP in the US.

· Upcoming

ASCO clinical presentation: The

Company will present updated durability of response data at the upcoming American Society

of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago from May 29 to June 2,

2026, with a presentation titled “Zopapogene imadenovec-drba,

a novel non-replicating adenoviral vector-based immunotherapy: Effects on complete and durable

responses in recurrent respiratory papillomatosis pivotal trial.”

· Strong

presence at key medical and scientific meetings: At AAO-HNSF 2025, SITC 2025, EUROGIN

2026, and COSM 2026, the Company presented long-term

durable complete responses with PAPZIMEOS,

and at ISPOR Europe 2025, the Company published data demonstrating the substantial

healthcare resource utilization and

patient-reported

quality-of-life burden of RRP,

underscoring the disease’s significant clinical, economic, and human impact.

· Redosing

study enrolling patients: The Company’s open-label study to evaluate safety, vector

shedding, and retreatment efficacy of zopapogene imadenovec-drba in adults with RRP is currently

enrolling (clinical trial identifier: NCT06538480).

· MAA under review by the EMA:

Following submission in November 2025, the Marketing Authorization Application for PAPZIMEOS for the treatment of adults with RRP was

validated by the European Medicines Agency and is under review. PAPZIMEOS was granted orphan

drug designation by the European Commission.

· RRP Awareness Day 2026: For

the third consecutive year, Precigen will collaborate with the Recurrent Respiratory Papillomatosis Foundation to co-host RRP Awareness

Day on June 11. The annual initiative is dedicated to educating the public and medical community about RRP by amplifying the voices of

patients, caregivers, advocates, and the healthcare community supporting them.

PRGN-2009 AdenoVerse® Immunotherapy in HPV-associated

Cancers

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

research and development agreement (CRADA) with the National Cancer Institute (NCI) in newly diagnosed HPV-associated oropharyngeal cancer

are ongoing.

· A multicenter Phase 2 clinical trial of PRGN-2009

in combination with pembrolizumab in recurrent/metastatic cervical cancer is ongoing.

· The Company plans to highlight progress across

its AdenoVerse portfolio, including an update on PRGN-2009, by end of year.

FINANCIAL HIGHLIGHTS

“We

are pleased with the launch performance of PAPZIMEOS, recognizing $21.6 million of net revenue in the first full quarter of its launch.

In the second quarter of 2026, we are seeing continued strength in revenue growth from PAPZIMEOS,” said Harry Thomasian Jr., Chief

Financial Officer of Precigen. “As of March 31, 2026, the Company’s cash, cash equivalents, and investments totaled $56.7

million, which based on payment terms, did not include any collection of PAPZIMEOS related accounts receivable since launch of approximately

$25.7 million. Based on our current revenue outlook and present financial forecast, we continue to believe that 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.

Our forecasted expenditures include additional investments to progress both clinical and pre-clinical assets.”

First Quarter 2026 Financial Results Compared

to Prior Year Period

Total revenues increased by $21.9 million compared

to the three months ended March 31, 2025. The significant increase in total revenues for the three months ended March 31, 2026 was due

to the ramp up of commercial sales of PAPZIMEOS following its FDA approval in August 2025. Revenues related to the sale of PAPZIMEOS for

the three months ended March 31, 2026 were $21.6 million. No PAPZIMEOS sales were recorded for the three months ended March 31, 2025,

as the product had not yet been approved.

R&D expenses decreased by $4.8 million compared

to the three months ended March 31, 2025, primarily due to the change in the accounting treatment of manufacturing costs as a result of

the FDA approval of PAPZIMEOS.

Selling, general, and administrative (SG&A)

expenses increased by $8.7 million compared to the three months ended March 31, 2025. This increase was primarily driven by commercial

activities related to PAPZIMEOS following its FDA approval in August 2025.

Total other expense, net, decreased by $29.6 million

compared to the three months ended March 31, 2025. This change was primarily attributable to the absence of a $32.5 million charge related

to the increase in the fair value of warrant liabilities that was recorded in the prior-year period. The remaining change (an increase

in other expense) primarily relates to an increase of $2.9 million in interest expenses related to long term debt that originated in the

third quarter of 2025.

Net loss was $7.9 million, or $0.02 per basic and diluted

share, for three months ended March 31, 2026, compared to a net loss of $54.2 million, or $0.18 per basic and diluted share,

for the three months ended March 31, 2025.

###

Precigen: Advancing Medicine 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.

Cautionary Statement Regarding Forward-Looking

Statements

This press release

contains “forward-looking” statements within the meaning of the safe harbor provisions of the US Private Securities Litigation

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 similar references to future

periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what

the Company expects. Examples of forward-looking statements include, among others, information relating to the Company’s business

and business plans, the success of efforts to commercialize PAPZIMEOS™ (zopapogene imadenovec-drba) for the treatment of 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 efficacy of PAPZIMEOS, the

ability of PAPZIMEOS to treat RRP, the Company’s future financial and operational results including the Company’s ability

to reach cash flow break-even, and the Company’s ability to commence clinical studies or complete ongoing clinical studies for the

Company’s clinical and pre-clinical stage candidates. The Company has no obligation to provide any updates to these forward-looking

statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary

statement. For further information on potential risks and uncertainties, and other important factors, any of which could cause the Company's

actual 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)

March 31, 2026

December 31, 2025

Assets

Current assets

Cash and cash equivalents

$ 7,480

$ 30,234

Short-term investments

48,766

67,624

Receivables

Trade, net

26,403

3,916

Other

302

446

Inventory

14,725

9,581

Prepaid expenses and other

3,996

3,434

Total current assets

101,672

115,235

Long-term investments

489

2,511

Property, plant and equipment, net

13,219

13,758

Intangible assets, net

2,864

3,182

Goodwill

15,232

Right-of-use assets

4,369

4,679

Other assets

782

908

Total assets

$ 138,627

$ 155,505

Liabilities and Shareholders' Equity

Current liabilities

Accounts payable

$ 2,589

$ 11,985

Accrued compensation and benefits

4,556

10,199

Other accrued liabilities

12,481

10,993

Indemnification accruals

—

2,476

Deferred revenue

410

517

Current portion of lease liabilities

1,068

1,136

Total current liabilities

21,104

37,306

Long-term debt

93,519

93,174

Lease liabilities, net of current portion

3,663

3,980

Other long-term liabilities

106

134

Total liabilities

118,392

134,594

Shareholders' equity

Additional paid-in capital

2,369,529

2,362,252

Accumulated deficit

(2,349,277 )

(2,341,348 )

Accumulated other comprehensive (loss) income

(17 )

Total shareholders' equity

20,235

20,911

Total liabilities and shareholders' equity

$ 138,627

$ 155,505

Precigen, Inc. and Subsidiaries

Consolidated Statement of Operations

(Unaudited)

(Amounts in thousands, except share

Three Months Ended

March 31,

and per share data)

2026

2025

Revenues

Product revenues, net

$ 21,828

$ 203

Service revenues

1,424

1,138

Total revenues

23,252

1,341

Operating Expenses

Cost of products and services

2,559

1,100

Research and development

5,638

10,478

Selling, general and administrative

21,049

12,359

Total operating expenses

29,246

23,937

Operating loss

(5,994 )

(22,596 )

Other Income (Expense), Net

Change in fair value of warrant liabilities

—

(32,481 )

Interest expense

(2,908 )

(1 )

Interest income

683

918

Other income, net

290

Total other income (expense), net

(1,935 )

(31,557 )

Loss before income taxes

(7,929 )

(54,153 )

Income tax expense

—

Net loss

$ (7,929 )

$ (54,153 )

Net loss per share

Net loss per share, basic and diluted

$ (0.02 )

$ (0.18 )

Weighted average shares outstanding, basic and diluted

354,291,007

293,879,653

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

+ Details

Name:

dei_SecurityExchangeName

Namespace Prefix:

dei_

Data Type:

dei:edgarExchangeCodeItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

+ Details

Name:

dei_SolicitingMaterial

Namespace Prefix:

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Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

Name:

dei_TradingSymbol

Namespace Prefix:

dei_

Data Type:

dei:tradingSymbolItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

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Namespace Prefix:

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