Precigen Reports First Quarter 2026 Financial Results and Business Updates
PGEN
Published on 05/13/2026 at 04:06 pm EDT
GERMANTOWN, Md., May 13, 2026 /PRNewswire/ -- 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.
PRGN-2009 AdenoVerse® Immunotherapy in HPV-associated CancersPRGN-2009 is an investigational AdenoVerse immunotherapy designed to activate the immune system to recognize and target HPV-associated cancers.
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 PeriodTotal 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.
TrademarksPrecigen, 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 StatementsThis 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. HarasymTel: +1 (202) [email protected]
Media Contact:Donelle M. [email protected]
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
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)
7
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
7
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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SOURCE Precigen, Inc.