Form 8-K

8-K — PRECIGEN, INC.

Accession: 0000950103-26-011876

Filed: 2026-08-04

Period: 2026-08-04

CIK: 0001356090

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Documents

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EX-99.1 — EXHIBIT 99.1 (dp251262_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):

August 4, 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 August 4, 2026, reporting its financial results for the quarter ended June 30, 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 August 4, 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: August 4, 2026

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: dp251262_ex9901.htm · Sequence: 2

Exhibit 99.1

Precigen Reports Second Quarter 2026 Financial

Results Highlighted by Accelerating PAPZIMEOS Revenue Growth

· PAPZIMEOS® net revenue of $53.1

million in the second quarter of 2026, more than double the prior quarter, reflects accelerating commercial momentum and broad US adoption

· PAPZIMEOS revenue propelled the Company to

quarterly profitability

· Cash, cash equivalents, and investments totaled

$38.7 million as of June 30, 2026, which together with proceeds from PAPZIMEOS revenue, is expected to support cash flow break-even by

the end of 2026

· PAPZIMEOS patient hub enrollment

reached well over 500 patients across major centers and community practices, demonstrating expanding reach and ease of administration

across treatment settings

· FDA granted PAPZIMEOS seven-year

market exclusivity, providing long-term protection against prospective competition

· Conference call scheduled

for 4:30 PM ET today

GERMANTOWN, MD, August 4, 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 second quarter 2026 financial results and business updates.

“We delivered a historic second quarter,

with the rapid adoption of PAPZIMEOS demonstrating the strength of our groundbreaking science and innovative commercial strategy,”

said Helen Sabzevari, PhD, President and CEO of Precigen. “This momentum provides a strong foundation for our next phase of growth

as we work to expand PAPZIMEOS globally and into the pediatric population. PAPZIMEOS demonstrates the AdenoVerse platform’s ability

to target HPV-associated diseases. We are building on that validated capability by advancing PRGN-2009 in HPV-driven cancers, with a pipeline

update expected by year-end. With growing commercial momentum, a validated platform, and multiple opportunities ahead, we believe Precigen

is well positioned to deliver sustained value for patients across various indications, the broader healthcare community, and our shareholders.”

“We continue to see the key elements of the

PAPZIMEOS commercial launch drive revenue growth: 100% field engagement with our initial target accounts, active patient and HCP campaigns,

a permanent J-code supporting access and site activations, payer coverage across nearly all insured US lives, growing physician consensus

reflected in a RRP position paper, and continued patient hub enrollments,” said Phil Tennant, Chief Commercial Officer of Precigen.

“This progress translated into strong quarterly revenue growth and increasing adoption across major medical centers and community

practices as PAPZIMEOS becomes established as a new standard of care for adults with RRP. We remain focused on converting demand into

treated patients and further expanding access to PAPZIMEOS across the RRP community.”

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

recurrent respiratory papillomatosis (RRP). PAPZIMEOS has been approved by the US Food and Drug Administration (FDA) for the treatment

of adults with RRP.

· Broad US adoption: Well over 500 patients

have registered through Precigen’s patient hub, with additional patients outside of the hub being identified and receiving treatment

as institutions support patient access directly and independently.

· Market exclusivity: PAPZIMEOS was granted

seven years of market exclusivity by the FDA, providing long-term protection against prospective competition. PAPZIMEOS remains the first

and only approved therapy for adults with RRP and the only treatment designed to target the underlying cause of the disease.

· Broad payer coverage: PAPZIMEOS

has payer coverage across approximately 315 million US lives through private health plans, Medicare, and Medicaid, representing nearly

100% of insured lives nationwide.

· Permanent J-code: The Centers for Medicare

and Medicaid Services assigned permanent J-code, J3404, to PAPZIMEOS, effective April 1, 2026. The J-code provides a standard pathway

for reimbursement, helps institutions process claims more efficiently, and reduces uncertainty for sites that are still building PAPZIMEOS

into their workflows.

· First-line standard of care: An expert

position paper sponsored and published by the Recurrent Respiratory Papillomatosis Foundation and authored by 16 leading RRP physicians

recommended PAPZIMEOS as the first-line standard of care for adults with RRP in the United States.

· Redosing

study enrolling patients: The Company’s open-label study to evaluate redosing efficacy

of zopapogene imadenovec in adults with RRP is currently enrolling (clinical trial identifier:

NCT06538480).

· MAA under review by the EMA: The European

Medicines Agency (EMA) has validated and is reviewing the Marketing

Authorization Application (MAA) submitted

in November 2025 for zopapogene imadenovec for the treatment of adults with RRP. PAPZIMEOS has been granted orphan drug designation

from the European Commission.

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 provide an update on progress

across the AdenoVerse portfolio, including PRGN-2009, by the end of the year.

FINANCIAL RESULTS

“We are thrilled to report that Precigen

achieved profitability in the second quarter, marking a significant milestone for the company. Net income was driven by strong PAPZIMEOS

revenue of $53.1 million. As we progress through the third quarter of 2026, we are seeing continued growth in PAPZIMEOS demand,"

said Harry Thomasian Jr., Chief Financial Officer of Precigen. “Based upon our current revenue trajectory 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.”

Second Quarter 2026 Financial Results Compared

to Prior Year Period

Total revenues were $55.0 million for the three

months ended June 30, 2026, an increase of $54.1 million compared to the three months ended June 30, 2025. The significant increase in

total revenues was primarily due to the recording of commercial sales of PAPZIMEOS. Revenues related to the sale of PAPZIMEOS for the

three months ended June 30, 2026 were $53.1 million.

Cost of products and services increased by $1.7

million, compared to the three months ended June 30, 2025, almost entirely due to costs related to the recording of commercial sales of

PAPZIMEOS following its FDA approval in August 2025. Prior to regulatory approval, costs associated with the production of PAPZIMEOS were

expensed as research and development in accordance with the Company’s accounting policy. Upon FDA approval and the commencement

of commercial sales, these costs are now capitalized as inventory and recognized in cost of product and services as product is sold.

R&D expenses decreased by $4.2 million, compared

to the three months ended June 30, 2025, primarily due to the change in the accounting treatment of PAPZIMEOS manufacturing costs. The

Company expects that R&D expenses will increase as the year progresses.

SG&A expenses increased by $6.1 million, compared

to the three months ended June 30, 2025. This increase was primarily driven by commercial activities related to PAPZIMEOS following its

FDA approval in August 2025. The higher expenses reflect increased costs to support commercialization, expanded marketing and promotional

activities to drive product awareness and adoption, and increased personnel costs, including stock compensation expense.

In the three months ended June 30, 2025, the Company

recorded $3.9 million in impairment related to its Exemplar reporting unit with no comparable charge in the second quarter of 2026.

Total other expense, net was $2.6 million for the

three months ended June 30, 2026 compared to other income, net of $5.1 million for the three months ended June 30, 2025, a change of $7.7

million. This change was primarily attributable to the absence of a $4.5 million gain related to the decrease in the fair value of warrant

liabilities that was recorded in the prior-year period. The remaining change primarily relates to an increase of $3.0 million in interest

expense related to long term debt that originated in the third quarter of 2025.

Net income was $20.1 million, or $0.06 per basic and $0.05

per diluted share for the three months ended June 30, 2026, compared to a net loss of $26.6 million, or $(0.09) per basic

and diluted share, for the three months ended June 30, 2025.

First Six Months 2026 Financial Results Compared

to Prior Year Period

Total revenues were $78.2 million for the six months

ended June 30, 2026, an increase of $76.0 million compared to the six months ended June 30, 2025. The significant increase in total revenues

was primarily due to the recording of commercial sales of PAPZIMEOS. Revenues related to the sale of PAPZIMEOS for the six months ended

June 30, 2026 were $74.7 million.

Cost of products and services increased by $3.2

million, compared to the six months ended June 30, 2025, almost entirely due to costs related to the recording of commercial sales of

PAPZIMEOS following its FDA approval in August 2025. Prior to regulatory approval, costs associated with the production of PAPZIMEOS were

expensed as research and development in accordance with the Company’s accounting policy. Upon FDA approval and the commencement

of commercial sales, these costs are now capitalized as inventory and recognized in cost of product and services as product is sold.

R&D expenses decreased by $9.0 million, compared

to the six months ended June 30, 2025, primarily due to the change in the accounting treatment of PAPZIMEOS manufacturing costs. The Company

expects that R&D expenses will increase as the year progresses.

SG&A expenses increased by $14.8 million, compared

to the six months ended June 30, 2025. This increase was primarily driven by commercial activities related to PAPZIMEOS following its

FDA approval in August 2025. The higher expenses reflect increased costs to support commercialization, expanded marketing and promotional

activities to drive product awareness and adoption, and increased personnel costs, including stock compensation expense.

In the six months ended June 30, 2025, the Company

recorded $3.9 million in impairment related to its Exemplar reporting unit with no comparable charge in the six months ended June 30,

2026.

Total other expense, net decreased by $21.9 million,

compared to the six months ended June 30, 2025. This decrease was primarily attributable to the absence of a $28.0 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 $5.9 million in interest expense related to long-term debt that was entered into

in the third quarter of 2025.

Net income was $12.1 million, or $0.03 per

basic and diluted share for the six months ended June 30, 2026, compared to a net loss of $80.8 million, or $(0.27) per basic

and diluted share, for the six months ended June 30, 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 quarterly profitability and 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)

June 30, 2026

December 31, 2025

Assets

Current assets

Cash and cash equivalents

$ 16,329

$ 30,234

Short-term investments

21,879

67,624

Receivables

Trade, net

71,866

3,916

Other

178

446

Inventory

20,245

9,581

Prepaid expenses and other

3,887

3,434

Total current assets

134,384

115,235

Long-term investments

490

2,511

Property, plant and equipment, net

12,802

13,758

Intangible assets, net

2,545

3,182

Goodwill

15,232

Right-of-use assets

4,135

4,679

Other assets

708

908

Total assets

$ 170,296

$ 155,505

Liabilities and Shareholders' Equity

Current liabilities

Accounts payable

$ 5,304

$ 11,985

Accrued compensation and benefits

6,498

10,199

Other accrued liabilities

16,212

10,993

Indemnification accruals

—

2,476

Deferred revenue

284

517

Current portion of lease liabilities

1,055

1,136

Total current liabilities

29,353

37,306

Long-term debt

93,880

93,174

Lease liabilities, net of current portion

3,410

3,980

Other long-term liabilities

134

Total liabilities

126,720

134,594

Shareholders' equity

Additional paid-in capital

2,372,811

2,362,252

Accumulated deficit

(2,329,206)

(2,341,348)

Accumulated other comprehensive (loss) income

(29)

Total shareholders' equity

43,576

20,911

Total liabilities and shareholders' equity

$ 170,296

$ 155,505

Precigen, Inc. and Subsidiaries

Consolidated Statement of Operations

(Unaudited)

(Amounts in thousands, except share

Three Months Ended

June 30,

Six Months Ended

June 30,

and per share data)

2026

2025

2026

2025

Revenues

Product revenues, net

$ 53,262

$ 41

$ 75,090

$ 244

Service revenues

1,716

815

3,140

1,953

Total revenues

54,978

856

78,230

2,197

Operating Expenses

Cost of products and services

2,805

1,092

5,364

2,192

Research and development

7,282

11,488

12,920

21,966

Selling, general and administrative

22,249

16,133

43,298

28,492

Impairment of goodwill

—

3,907

—

3,907

Total operating expenses

32,336

32,620

61,582

56,557

Operating income (loss)

22,642

(31,764)

16,648

(54,360)

Other Income (Expense), Net

Change in fair value of warrant liabilities

—

4,460

—

(28,021)

Interest expense

(2,953)

—

(5,861)

(1)

Interest income

366

696

1,049

1,614

Other income (expense), net

(31)

306

(24)

Total other income (expense), net

(2,571)

5,125

(4,506)

(26,432)

Income (loss) before income taxes

20,071

(26,639)

12,142

(80,792)

Income tax expense

—

(3)

—

(3)

Net income (loss)

$ 20,071

$ (26,642)

$ 12,142

$ (80,795)

Net income (loss) per share

Net income (loss) per share, basic

$ 0.06

$ (0.09)

$ 0.03

$ (0.27)

Net income (loss) per share, diluted

$ 0.05

$ (0.09)

$ 0.03

$ (0.27)

Weighted average shares outstanding, basic

356,893,568

296,434,726

355,599,477

295,164,303

Weighted average shares outstanding, diluted

413,686,865

296,434,726

412,552,647

295,164,303

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

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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.

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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.

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