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Precigen Q3 2026 earnings turn to $35.8M profit

Operating cash flow was positive at $11.9 million, a full quarter ahead of the company's prior guidance for year-end.

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Form Type
8-K

Rhea-AI Filing Summary

Precigen, Inc. reported third-quarter 2026 total revenue of $74.148 million, including $72.959 million of PAPZIMEOS net product revenue, which management said grew 37% quarter over quarter. Total revenue was $2.922 million a year earlier. Net income was $35.766 million, compared with a $146.344 million net loss, and net cash provided by operating activities was $11.9 million, a full quarter ahead of the company's prior guidance for positive cash flow by year-end.

For the first nine months of 2026, revenue was $152.378 million and net income was $47.908 million, compared with $5.119 million in revenue and a $227.139 million net loss in 2025. The prior-year third quarter included a $111.502 million charge from the change in fair value of warrant liabilities. Precigen said lower R&D expense partly reflected the post-approval accounting treatment: production costs were capitalized as inventory and recognized in cost of product and services as the product was sold.

The FDA granted Precigen's AdenoVerse platform a Platform Technology Designation in September 2026. PAPZIMEOS is the first FDA-approved therapy for adults with recurrent respiratory papillomatosis (RRP). As of November 4, 2026, Precigen reported well over 500 patients had started treatment and over 300 had completed it.

3 points · 0 major

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Positive

  • Moderate pointThird-quarter revenue reached $74.148 million, versus $2.922 million a year earlier.
  • Moderate pointThird-quarter net income was $35.766 million, compared with a $146.344 million net loss.
  • Moderate pointOperating cash flow reached $11.9 million, a full quarter ahead of prior guidance.

Negative

  • None.

Filing Explained

The balance-sheet snapshot adds liquidity and debt detail: at September 30, 2026, Precigen reported $50,980,000 in cash and investments alongside $94,256 thousand in long-term debt.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Total revenue $74.148 million Three months ended September 30, 2026; $2.922 million in the prior-year quarter.
PAPZIMEOS net product revenue $72.959 million Three months ended September 30, 2026.
Quarter-over-quarter PAPZIMEOS revenue growth 37% Third quarter 2026, as stated by management.
Net income $35.766 million Three months ended September 30, 2026; compared with a $146.344 million net loss in the prior-year quarter.
Net cash provided by operating activities $11.9 million Third quarter 2026.
Total revenue $152.378 million Nine months ended September 30, 2026; $5.119 million in the prior-year period.
Net income $47.908 million Nine months ended September 30, 2026; compared with a $227.139 million net loss in the prior-year period.
Platform Technology Designation regulatory
"FDA granted Platform Technology Designation to its AdenoVerse immunotherapeutic platform"
A platform technology designation means a company’s core scientific method, software, or manufacturing approach is recognized as a reusable foundation that can support multiple products or applications. For investors, it signals potential for faster product development, lower marginal costs and diversified revenue streams—like a single toolkit that can build many different devices—so the business can scale more efficiently and spread risk across several programs.
non-replicating adenoviral vector-based immunotherapy medical
"PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy"
A non-replicating adenoviral vector-based immunotherapy is a treatment that uses a harmless, disabled virus as a delivery truck to carry genetic instructions into the body’s cells so the immune system learns to recognize and attack a disease, such as a tumor or an infection. It matters to investors because this approach can offer targeted effects and a generally safer profile than live viruses, creating significant commercial and regulatory upside if clinical trials succeed, but also carrying typical biotech development and approval risks.
recurrent respiratory papillomatosis medical
"first FDA-approved therapy for adults with recurrent respiratory papillomatosis (RRP)"
Recurrent respiratory papillomatosis is a rare condition in which benign but repeatedly returning growths form in the airways, especially the voice box and windpipe, causing hoarseness, breathing trouble and frequent need for medical procedures. For investors, it matters because the chronic, recurring nature of the disease drives ongoing demand for surgeries, drugs, and medical devices, and makes it a target for new therapies and regulatory reviews that can affect healthcare spending and company revenues.
warrant liabilities financial
"charge related to the increase in the fair value of warrant liabilities"
Warrant liabilities are the financial obligations a company records when it grants warrants—special rights allowing someone to buy shares at a set price in the future. If the warrants are expected to be exercised, they are treated as a liability because the company might need to deliver shares or cash later. This matters to investors because it affects the company’s reported financial health and the potential dilution of existing shares.
capitalized as inventory financial
"production costs are capitalized as inventory on the balance sheet"
deemed dividend financial
"one-time $179.0 million non-cash deemed dividend on preferred stock"
A deemed dividend is a tax and accounting rule that treats certain transactions as if the company paid a dividend to shareholders even when no actual cash distribution was made. Examples include forgiveness of shareholder debt, transfers of assets at below-market value, or some related-party transactions; treating them as dividends can change reported retained earnings and create tax liabilities. Investors care because deemed dividends can alter a company’s reported equity, affect future cash availability, and create tax consequences for shareholders, similar to realizing value from the company without a formal cash payout.
Total revenue $74.148 million Increased by $71.2 million from the prior-year quarter.
PAPZIMEOS net product revenue $72.959 million Management reported 37% quarter-over-quarter growth.
Net income $35.766 million Compared with a $146.344 million net loss in the prior-year quarter.
Net cash provided by operating activities $11.9 million Achieved a full quarter ahead of prior guidance for positive cash flow by year-end.
Total revenue $152.378 million Increased by $147.3 million from the prior-year period.
Net income $47.908 million Compared with a $227.139 million net loss in the prior-year period.
Guidance

Precigen previously guided to positive cash flow by the end of the year and reported achieving it a full quarter ahead.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

How much revenue did PGEN report in Q3 2026?

PGEN reported $74.148 million in total revenue for the three months ended September 30, 2026, including $72.959 million in PAPZIMEOS net product revenue. Precigen said PAPZIMEOS revenue grew 37% quarter over quarter; total revenue in the year-earlier quarter was $2.922 million.

Did PGEN report net income and positive operating cash flow in Q3 2026?

Yes. Precigen reported $35.766 million in net income and $11.9 million in net cash provided by operating activities for the third quarter of 2026. The company said it achieved positive cash flow a full quarter ahead of its prior guidance for positive cash flow by year-end.

What does the FDA's AdenoVerse designation mean for PGEN?

The FDA granted the AdenoVerse immunotherapeutic platform a Platform Technology Designation in September 2026. Precigen said the designation creates opportunities to expedite development of current and future candidates by leveraging existing manufacturing and preclinical data and enabling earlier, more frequent engagement with the FDA.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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false 0001356090 0001356090 2026-11-04 2026-11-04 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

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): November 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 November 4, 2026, reporting its financial results for the quarter ended September 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 November 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: November 4, 2026

 

 

 

Exhibit 99.1

 

 

 

 

Precigen Reports Third Quarter 2026 Results Highlighted by Strong Sequential PAPZIMEOS Revenue Growth and Positive Cash Flow Ahead of Guidance

 

·PAPZIMEOS® net revenue rose 37% quarter-over-quarter to $72.9 million in the third quarter of 2026 bringing launch-to-date net product revenue to $151 million, underscoring sustained commercial momentum and expanding US adoption

·Achieved positive cash flow in the third quarter of 2026, a full quarter ahead of guidance, driven by robust PAPZIMEOS uptake

·Net income for the third quarter of $35.8 million

·Cash, cash equivalents, and investments totaled $51.0 million as of September 30, 2026

·Received FDA Platform Technology Designation for the AdenoVerse® platform, creating opportunities to expedite development of current and future therapies

·New long-term follow-up data presented at AAO-HNSF 2026 demonstrated ongoing durable complete responses after PAPZIMEOS treatment for up to five years

·Conference call scheduled for 4:30 PM ET today

 

GERMANTOWN, MD, November 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 third quarter 2026 financial results and business updates.

 

“Precigen has established an exceptional position of strength, with commercial momentum and a proven strategy driving our next phase of growth,” said Helen Sabzevari, PhD, President and CEO of Precigen. “PAPZIMEOS has transformed treatment for adults with RRP, with well over 500 patients initiating treatment and 300 of them having completed treatment demonstrating recognition as the first-line standard of care. Its compelling value proposition is supported by an unmatched 51% complete response rate, ongoing durable complete responses up to five years, a well-characterized safety profile, and straightforward administration without a specialized device. PAPZIMEOS also received full FDA approval without the need for a confirmatory trial. Strong commercial uptake has driven sequential revenue growth and positive cash flow ahead of guidance, putting us well on our way to realizing its blockbuster potential. We are actively advancing a comprehensive lifecycle strategy to unlock the full potential of PAPZIMEOS with ongoing redosing clinical trial, pediatric development, and geographic expansion activities. PAPZIMEOS has established a powerful foundation for our next chapter, and the FDA’s Platform Technology Designation positions us to realize the broader potential of AdenoVerse to advance our portfolio.”

 

“PAPZIMEOS net revenue grew 37% quarter-over-quarter to $72.9 million, demonstrating the strength of our commercial execution and growing demand for the first FDA-approved therapy for adults with RRP,” said Phil Tennant, Chief Commercial Officer of Precigen. “As of today, well over 500 patients have begun PAPZIMEOS treatment and over 300 of them have completed treatment. Physicians are increasingly making PAPZIMEOS their treatment of choice, driven by its compelling efficacy, safety and long-term durability. We have established a commanding first-mover advantage, supported by broad payer coverage, a permanent J-code and a straightforward treatment experience, with subcutaneous administration that requires no specialized devices. With a substantial addressable patient population, we continue to build on this momentum as we deepen adoption, expand patient access and capitalize on PAPZIMEOS as the preferred first-line treatment for adults with RRP.”

 

“PAPZIMEOS has fundamentally transformed how we treat adults with RRP, establishing a new first-line standard of care for a disease that, for more than a century, was managed primarily through repeated surgeries. The potential for durable freedom from surgery, combined with demonstrated clinical efficacy, a well-characterized safety profile, and straightforward subcutaneous administration, represents a remarkable advance for our patients,” said Dr. Clark A. Rosen, Lewis Francis Morrison, MD Endowed Chair in Laryngology, Professor, Department of Otolaryngology – Head and Neck Cancer Center, Chief, Division of Laryngology, Co-Director, UCSF Voice and Swallowing Center, University of California, San Francisco. “We are moving beyond simply managing the recurrence of disease to a treatment approach that offers the possibility of sustained disease control.”


KEY PLATFORM AND PROGRAM HIGHLIGHTS

 

AdenoVerse® Platform Technology Designation

In September 2026, Precigen announced that the US Food and Drug Administration (FDA) granted Platform Technology Designation to its AdenoVerse immunotherapeutic platform, building on the successful FDA approval of PAPZIMEOS, the first AdenoVerse-based therapy. The designation recognizes the platform’s potential to be applied across multiple therapies and creates opportunities to expedite development of current and future AdenoVerse-based candidates by leveraging existing manufacturing and preclinical data, reducing duplicative development efforts, and enabling earlier and more frequent engagement with the FDA.

 

 

 

 

PAPZIMEOS®: First-line Standard of Care for the Treatment of Adults with RRP

PAPZIMEOS (zopapogene imadenovec-drba) is the first FDA-approved therapy for adults with recurrent respiratory papillomatosis (RRP). PAPZIMEOS 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.

 

·Full approval with unmatched efficacy: PAPZIMEOS received full FDA approval in August 2025, with a broad label and without the requirement for a post-approval confirmatory clinical trial to verify clinical benefit. In its pivotal clinical study, PAPZIMEOS demonstrated a 51% complete response rate (18 of 35 patients), defined as no surgeries during the 12 months following treatment completion. This primary efficacy result, reflected in its FDA-approved prescribing information, established a new clinical benchmark in RRP.

·Established safety profile and straightforward administration: In the pivotal clinical study, PAPZIMEOS demonstrated a well-characterized safety profile, with no dose-limiting toxicities or treatment-related adverse events greater than Grade 2 reported. PAPZIMEOS is administered subcutaneously without the need for an external specialized administration device, supporting adoption across a broad range of clinical settings.

·Unmatched durability: Updated long-term follow-up data presented at the 2026 American Academy of Otolaryngology–Head and Neck Surgery Foundation (AAO-HNSF) Annual Meeting demonstrated sustained ongoing complete responses following PAPZIMEOS treatment for up to five years. Responses remain ongoing, and follow-up continues.

·Preferred first-line treatment: PAPZIMEOS has become the first-line standard of care treatment for adult RRP patients. An independent expert consensus paper sponsored by the Recurrent Respiratory Papillomatosis Foundation (RRPF) and authored by 16 leading RRP physicians recommends PAPZIMEOS as the preferred first-line treatment and it is widely recognized as the new standard of care.

·Significant first-mover advantage: As the first FDA-approved therapy for adults with RRP, PAPZIMEOS has established a significant first-mover advantage, supported by broad commercial access and growing adoption across major centers, a network of infusion centers and community practices.

·Strong commercial adoption: Within just over one year following FDA approval, well over 500 patients have initiated treatment with PAPZIMEOS, with well over 300 of them completing treatment. Rapid adoption across academic and community settings, including among patients with fewer than three surgeries in the preceding year, demonstrates strong physician uptake across the spectrum of RRP disease severity.

·Broad payer coverage and streamlined reimbursement: PAPZIMEOS has payer coverage across over 315 million US lives through private health plans, Medicare and Medicaid, representing nearly 100% of insured lives nationwide. The permanent J-code, J3404, effective April 1, 2026, provides a standardized reimbursement pathway, supporting efficient claims processing and facilitating broader institutional adoption.

·Redosing study enrolling patients: Enrollment in the Company’s open-label study to evaluate redosing efficacy of zopapogene imadenovec in adults with RRP is ongoing (clinical trial identifier: NCT06538480). The goal of the study is to provide an opportunity for the partial responders to become complete responders.

·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 Diseases

PRGN-2009 is an investigational AdenoVerse immunotherapy designed to activate the immune system to recognize and target HPV-associated diseases.

·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 present new Phase 2 clinical data from its PRGN-2009 program in newly diagnosed HPV-associated oropharyngeal cancer at a forthcoming R&D Day, together with a comprehensive update on PRGN-2009 and its broader AdenoVerse development strategy.

 

FINANCIAL RESULTS

 

“The third quarter marked another significant financial milestone for Precigen,” said Harry Thomasian Jr., Chief Financial Officer of Precigen. “PAPZIMEOS net revenue grew 37% quarter-over-quarter to $72.9 million, driving net income of $35.8 million, or $0.08 per diluted share. We previously guided to positive cash flow by the end of the year, and we are pleased to have achieved it a full quarter ahead of that guidance, with net cash provided by operating activities of $11.9 million. These results reflect strong PAPZIMEOS uptake and our disciplined approach to spending. These results are particularly remarkable given that PAPZIMEOS launched just one year ago, and we expect continued revenue momentum as adoption grows while we maintain our focus on fiscal responsibility.”

 

 

 

 

Third Quarter 2026 Financial Results Compared to Prior Year Period

Total revenues were $74.1 million for the three months ended September 30, 2026, an increase of $71.2 million compared to the three months ended September 30, 2025. The significant increase in total revenues was primarily due to the recording of commercial sales of PAPZIMEOS following its FDA approval in August 2025. Net product revenues from PAPZIMEOS for the three months ended September 30, 2026 were $72.9 million. No PAPZIMEOS sales were recorded for the three months ended September 30, 2025. The increase in total revenues was partially offset by a $1.8 million decrease in collaboration and licensing revenue.

 

Cost of product and services increased by $5.5 million, or greater than 500%, compared to the three months ended September 30, 2025, primarily due to costs related to the commercial sale of PAPZIMEOS following its FDA approval in August 2025. These costs include the cost of product sold as well as other production-related costs that do not meet the criteria for capitalization as inventory. 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.

 

R&D expenses decreased by $5.7 million, or 46.4%, compared to the three months ended September 30, 2025, primarily due to the change in the accounting treatment of PAPZIMEOS manufacturing costs. Prior to the FDA approval of PAPZIMEOS in August 2025, costs associated with the manufacturing of PAPZIMEOS were expensed as R&D. Following the FDA approval and the commencement of commercial sales, these production costs are no longer expensed as research and development but are capitalized as inventory on the balance sheet and recognized as cost of product and services as the product is sold. The decrease also reflects lower performance-based compensation expense compared to the prior year period.

 

SG&A expenses decreased by $1.6 million, or 6.8%, compared to the three months ended September 30, 2025, primarily driven by lower performance-based compensation expense in the current year period. This decrease was offset by higher compensation and benefit expense related primarily to the expansion of the Company's workforce as well as increases in marketing and freight expenses, both driven by the commercial launch of PAPZIMEOS.

 

Total other expense, net decreased by $109.2 million, or 97.6% compared to the three months ended September 30, 2025, primarily attributable to the absence of a $111.5 million charge related to the increase in the fair value of warrant liabilities that was recorded in the prior-year period. This decrease was offset by an increase of $2.1 million in interest expense related to long-term debt entered into in the third quarter of 2025.

 

During the third quarter of 2025, the Company recorded a one-time $179.0 million non-cash deemed dividend on preferred stock 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 Generally Accepted Accounting Principles ("GAAP"). On September 15, 2025, all of the then outstanding preferred shares were converted into common shares.

 

Net income was $35.8 million, or $0.10 per basic and $0.08 per diluted share for the three months ended September 30, 2026, compared to a net loss attributable to common shareholders of $325.3 million, or $1.06 per basic and diluted share, for the three months ended September 30, 2025.

 

First Nine Months 2026 Financial Results Compared to Prior Year Period

Total revenues were $152.4 million for the nine months ended September 30, 2026, an increase of $147.3 million compared to the nine months ended September 30, 2025. The significant increase in total revenues was primarily due to the recording of commercial sales of PAPZIMEOS following its FDA approval in August 2025. Revenues related to the sale of PAPZIMEOS for the nine months ended September 30, 2026 were $147.6 million. No PAPZIMEOS sales were recorded for the nine months ended September 30, 2025. Service revenue also increased $1.4 million, primarily due to higher revenue generated by the Company’s Exemplar subsidiary.

 

Cost of product and services increased by $8.6 million, or greater than 250%, compared to the nine months ended September 30, 2025, primarily due to costs related to the commercial sale of PAPZIMEOS following its FDA approval in August 2025. These costs include the cost of product sold as well as other production-related costs that do not meet the criteria for capitalization as inventory. 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.

 

R&D expenses decreased by $14.8 million, or 43.1%, compared to the nine months ended September 30, 2025, primarily due to the change in the accounting treatment of PAPZIMEOS manufacturing costs. Prior to the FDA approval of PAPZIMEOS in August 2025, costs associated with the manufacturing of PAPZIMEOS were expensed as R&D, as regulatory approval and the probability of future economic benefit had not yet been established. Following the FDA approval and the commencement of commercial sales, these production costs are no longer expensed as research and development but are capitalized as inventory on the balance sheet and recognized as cost of product and services as the product is sold.

 

 

 

 

SG&A expenses increased by $13.2 million, or 25.1%, compared to the nine months ended September 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, including third-party commercialization costs, freight expenses, expanded marketing and promotional activities to drive product awareness and adoption, and increased software subscription costs.

 

During the nine months ended September 30, 2025, we recorded a $3.9 million goodwill impairment charge related to the Company’s Exemplar reporting unit with no comparable charge in the nine months ended September 30, 2026.

 

Total other expense, net decreased by $131.1 million, or 94.8%, compared to the nine months ended September 30, 2025, primarily attributable to the absence of a $139.5 million charge related to the increase in the fair value of warrant liabilities that was recorded in the prior-year period. The increase in warrant liabilities was mainly driven by a rise in the Company's common stock price and, to a lesser extent, by an increase in the liability for additional warrants that were expected at that point to be issued as paid-in-kind dividends on the Company’s then outstanding Series A Preferred Stock. This decrease was offset by an increase of $8.0 million in interest expense related to long-term debt that was entered into in the third quarter of 2025.

 

During the nine months ended September 30, 2025, the Company recorded a one-time $179.0 million non-cash deemed dividend on preferred stock 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 GAAP. On September 15, 2025, all of the then outstanding preferred shares were converted into common shares.

 

Net income was $47.9 million, or $0.13 per basic and $0.12 per diluted share for the nine months ended September 30, 2026, compared to a net loss attributable to common shareholders of $406.1 million, or $1.36 per basic and diluted share, for the nine months ended September 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 or maintain quarterly profitability and positive cash flow, 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)  September 30, 2026  December 31, 2025
Assets          
Current assets          
    Cash and cash equivalents  $14,959   $30,234 
    Short-term investments   31,112    67,624 
    Receivables          
        Trade, net   96,486    3,916 
        Other   133    446 
    Inventory   22,915    9,581 
    Prepaid expenses and other   6,157    3,434 
                Total current assets   171,762    115,235 
Long-term investments   4,909    2,511 
Property, plant and equipment, net   13,295    13,758 
Intangible assets, net   2,227    3,182 
Goodwill   15,232    15,232 
Right-of-use assets   4,043    4,679 
Other assets   634    908 
                Total assets  $212,102   $155,505 
Liabilities and Shareholders' Equity          
Current liabilities          
    Accounts payable  $7,056   $11,985 
    Accrued compensation and benefits   7,855    10,199 
    Other accrued liabilities   14,568    10,993 
    Indemnification accruals   —      2,476 
    Deferred revenue   174    517 
    Current portion of lease liabilities   1,135    1,136 
                Total current liabilities   30,788    37,306 
Long-term debt   94,256    93,174 
Lease liabilities, net of current portion   3,216    3,980 
Other long-term liabilities   48    134 
                Total liabilities   128,308    134,594 
Shareholders' equity          
    Additional paid-in capital   2,377,321    2,362,252 
    Accumulated deficit   (2,293,440)   (2,341,348)
    Accumulated other comprehensive (loss) income   (87)   7 
                Total shareholders' equity   83,794    20,911 
                Total liabilities and shareholders' equity  $212,102   $155,505 

 

 

 

Precigen, Inc. and Subsidiaries 

Consolidated Statement of Operations 

(Unaudited)

 

(Amounts in thousands, except share 

Three Months Ended 

 September 30, 

 

Nine Months Ended  

 September 30, 

and per share data)  2026  2025  2026  2025
Revenues            
Product revenues, net  $72,959   $162   $148,049   $406 
Service revenues   1,189    942    4,329    2,895 
Collaboration and licensing revenues   —      1,818    —      1,818 
Total revenues   74,148    2,922    152,378    5,119 
Operating Expenses                    
Cost of products and services   6,508    1,035    11,872    3,227 
Research and development   6,631    12,377    19,551    34,343 
Selling, general and administrative   22,359    23,991    65,657    52,483 
Impairment of goodwill   —      —      —      3,907 
Total operating expenses   35,498    37,403    97,080    93,960 
Operating income (loss)   38,650    (34,481)   55,298    (88,841)
Other Income (Expense), Net                    
Change in fair value of warrant liabilities   —      (111,502)   —      (139,523)
Interest expense   (2,996)   (902)   (8,857)   (903)
Interest income   323    534    1,372    2,148 
Other income (expense), net   (11)   7    295    (17)
Total other expense, net   (2,684)   (111,863)   (7,190)   (138,295)
Income (loss) before income taxes   35,966    (146,344)   48,108    (227,136)
Income tax expense   (200)   —      (200)   (3)
Net income (loss)  $35,766   $(146,344)  $47,908   $(227,139)
Deemed dividends on preferred stock   —      (179,000)   —      (179,000)
Net income (loss) attributable to common   shareholders  $35,766   $(325,344)  $47,908   $(406,139)
Net income (loss) per share                    
Net income (loss) per share, basic  $0.10   $(1.06)  $0.13   $(1.36)
Net income (loss) per share, diluted  $0.08   $(1.06)  $0.12   $(1.36)
Weighted average shares outstanding, basic   358,249,260    307,170,490    356,492,444    299,210,344 
Weighted average shares outstanding, diluted   421,162,494    307,170,490    415,432,302    299,210,344 

 

 

 

 

 

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