Precigen Reports Third Quarter 2026 Results Highlighted by Strong Sequential PAPZIMEOS Revenue Growth and Positive Cash Flow Ahead of Guidance
PAPZIMEOS uptake helped operating activities generate $11.9 million in cash, reaching positive cash flow a quarter ahead of guidance.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Precigen (Nasdaq: PGEN) reported third-quarter 2026 PAPZIMEOS net revenue of $72.9 million, up 37% from the preceding quarter. Net income was $35.8 million, or $0.08 per diluted share, versus a $325.3 million net loss attributable to common shareholders a year earlier. Operating activities generated $11.9 million in cash, achieving positive cash flow one quarter ahead of guidance. Cash, cash equivalents and investments totaled $51.0 million at September 30, 2026.
New PAPZIMEOS follow-up data showed ongoing complete responses lasting up to five years. The FDA granted Platform Technology Designation to AdenoVerse. PAPZIMEOS redosing enrollment continues, and its European marketing application remains under review. Precigen plans pediatric development and geographic expansion, plus new Phase 2 PRGN-2009 data at a forthcoming R&D Day. Nine-month revenue reached $152.4 million, up $147.3 million year over year.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointPAPZIMEOS third-quarter net revenue rose 37% quarter over quarter to $72.9 million.
- Moderate pointThird-quarter net income reached $35.8 million versus a $325.3 million prior-year net loss attributable to common shareholders.
- Moderate pointOperating cash flow of $11.9 million achieved positive cash flow one quarter ahead of guidance.
- Moderate pointNine-month revenue increased $147.3 million year over year to $152.4 million.
- Minor pointNine-month service revenue increased $1.4 million, primarily from higher Exemplar revenue.
13 minor points
- Minor pointThird-quarter R&D expenses decreased $5.7 million, or 46.4%, primarily reflecting changed manufacturing-cost accounting.
- Minor pointNine-month R&D expenses decreased $14.8 million, or 43.1%, primarily reflecting changed manufacturing-cost accounting.
- Minor pointThird-quarter selling, general and administrative expenses decreased $1.6 million, or 6.8%, year over year.
- Minor pointThird-quarter other expense, net decreased $109.2 million, or 97.6%, primarily from an absent prior-year warrant-liability charge.
- Minor pointPAPZIMEOS follow-up data showed ongoing complete responses lasting up to five years.
- Minor point. Forward-looking: it has not happened yet and may not happen.AdenoVerse FDA Platform Technology Designation creates opportunities to expedite development using existing manufacturing and preclinical data.
- Minor pointPAPZIMEOS treatment uptake reached well over 500 patients initiating treatment, with well over 300 completing treatment.
- Minor pointPAPZIMEOS payer coverage spans over 315 million US lives, representing nearly 100% of insured lives nationwide.
- Minor pointPAPZIMEOS permanent reimbursement code J3404 became effective April 1, 2026.
- Minor pointPAPZIMEOS redosing study continues enrolling adults with recurrent respiratory papillomatosis to evaluate redosing efficacy.
- Minor point. Forward-looking: it has not happened yet and may not happen.PAPZIMEOS lifecycle plans include pediatric development and geographic expansion.
- Minor pointPRGN-2009 Phase 2 trials continue in newly diagnosed HPV-associated oropharyngeal cancer and recurrent/metastatic cervical cancer.
- Minor point. Forward-looking: it has not happened yet and may not happen.New PRGN-2009 Phase 2 data are planned for a forthcoming R&D Day.
Negative
- Minor pointThird-quarter collaboration and licensing revenue decreased $1.8 million year over year.
- Minor pointThird-quarter cost of product and services increased $5.5 million, or greater than 500%, year over year.
- Minor pointNine-month cost of product and services increased $8.6 million, or greater than 250%, year over year.
- Minor pointNine-month selling, general and administrative expenses increased $13.2 million, or 25.1%, year over year.
- Minor pointThird-quarter interest expense increased $2.1 million, related to long-term debt entered into in third-quarter 2025.
- Minor pointPAPZIMEOS European marketing authorization remains pending, with the application under European Medicines Agency review.
Key Figures
- PAPZIMEOS net product revenue
- $72.9 million
- Third quarter 2026
- Quarter-over-quarter revenue growth
- 37%
- PAPZIMEOS net product revenue, third quarter 2026
- Launch-to-date net product revenue
- $151 million
- PAPZIMEOS
- Net income
- $35.8 million
- Third quarter 2026
- Diluted EPS
- $0.08
- Third quarter 2026
- Net cash provided by operating activities
- $11.9 million
- Third quarter 2026
- Cash, cash equivalents, and investments
- $51.0 million
- As of September 30, 2026
- Ongoing complete responses
- Up to five years
- Long-term follow-up after PAPZIMEOS treatment
Previous Earnings Reports
-
PAPZIMEOS product revenue reached $53.1 million, and the company reported $20.1 million in net income.
-
PAPZIMEOS launch generated $21.6 million in product revenue, while net loss narrowed to $7.9 million.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
platform technology designation regulatory
complete response rate medical
dose-limiting toxicities medical
marketing authorization application regulatory
orphan drug designation regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
- PAPZIMEOS® net revenue rose
37% quarter-over-quarter to in the third quarter of 2026 bringing launch-to-date net product revenue to$72.9 million , underscoring sustained commercial momentum and expanding US adoption$151 million - 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
as of September 30, 2026$51.0 million - 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
"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
"PAPZIMEOS net revenue grew
"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
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
Third Quarter 2026 Financial Results Compared to Prior Year Period
Total revenues were
Cost of product and services increased by
R&D expenses decreased by
SG&A expenses decreased by
Total other expense, net decreased by
During the third quarter of 2025, the Company recorded a one-time
Net income was
First Nine Months 2026 Financial Results Compared to Prior Year Period
Total revenues were
Cost of product and services increased by
R&D expenses decreased by
SG&A expenses increased by
During the nine months ended September 30, 2025, the Company recorded a
Total other expense, net decreased by
During the nine months ended September 30, 2025, we recorded a one-time
Net income was
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 |
$ 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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SOURCE Precigen, Inc.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
How much PAPZIMEOS revenue did Precigen report for third-quarter 2026?
PAPZIMEOS net revenue was $72.9 million for the three months ended September 30, 2026, up 37% quarter over quarter. Launch-to-date net product revenue reached $151 million.
Did Precigen achieve positive cash flow in third-quarter 2026?
Precigen achieved positive cash flow in third-quarter 2026, with $11.9 million in net cash provided by operating activities. This was one quarter ahead of its guidance to reach positive cash flow by year-end.
Why did Precigen's research and development expenses decline in 2026?
The decline primarily reflected a change in PAPZIMEOS manufacturing-cost accounting after FDA approval. Before approval, manufacturing costs were expensed as research and development; afterward, production costs were capitalized as inventory and recognized as cost of product and services as the product was sold. Lower performance-based compensation also contributed to the third-quarter decline.
What did Precigen's pivotal PAPZIMEOS study show?
The pivotal study reported a 51% complete response rate, with 18 of 35 patients requiring no surgeries during the 12 months after treatment completion. No dose-limiting toxicities or treatment-related adverse events greater than Grade 2 were reported.