Precigen Reports First Quarter 2026 Financial Results and Business Updates
Rhea-AI Summary
Precigen (Nasdaq:PGEN) reported first quarter 2026 results driven by the US launch of PAPZIMEOS, generating $21.6 million in net product revenue. Total revenue rose $21.9 million year-over-year, while net loss narrowed to $7.9 million.
Cash, cash equivalents, and investments were $56.7 million at March 31, 2026, excluding about $25.7 million of PAPZIMEOS receivables. According to Precigen, these resources and expected PAPZIMEOS revenue are projected to fund operations to cash flow break-even by end of 2026. PAPZIMEOS has roughly 400 hub-enrolled patients, payer coverage for about 297 million US lives, a permanent J-code effective April 1, 2026, and an EMA marketing application under review. The company continues Phase 2 trials of PRGN-2009 in HPV-associated cancers and plans an AdenoVerse pipeline update by year-end.
Positive
- PAPZIMEOS net product revenue of $21.6 million in Q1 2026
- Total revenues increased by $21.9 million year-over-year in Q1 2026
- Net loss reduced to $7.9 million from $54.2 million year-over-year
- Cash, equivalents, and investments of $56.7 million plus $25.7 million receivables
- R&D expenses decreased by $4.8 million versus Q1 2025
- PAPZIMEOS payer coverage estimated at 297 million US insured lives
- Permanent PAPZIMEOS J-code (J3404) effective April 1, 2026
- EMA marketing application for PAPZIMEOS validated and under review
Negative
- Company remains loss-making with $7.9 million net loss in Q1 2026
- SG&A expenses increased by $8.7 million versus Q1 2025
- Interest expense rose by $2.9 million due to long-term debt originated in Q3 2025
News Market Reaction – PGEN
In the May 14 session, PGEN gained 10.84%, reflecting a significant positive market reaction. Argus tracked a peak move of +23.5% during that session. Our momentum scanner triggered 32 alerts that day, indicating elevated trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Earnings Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Mar 25 | Full-year 2025 results | Positive | +25.5% | First full-year as commercial company with PAPZIMEOS revenue and strong cash. |
| Nov 13 | Q3 2025 earnings | Positive | +25.6% | Post-approval PAPZIMEOS launch metrics and durable response data in RRP. |
| May 14 | Q1 2025 earnings | Positive | +2.3% | Strong PRGN-2012 data and BLA under priority review with August 2025 PDUFA. |
| Mar 19 | Full-year 2024 results | Positive | +0.6% | Priority review for PRGN-2012 BLA and extended cash runway into 2026. |
| Nov 14 | Q3 2024 earnings | Negative | -7.1% | Higher net loss plus equity offering and workforce reduction tied to focus on PRGN-2012. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Earnings-related updates have generally been received positively, with prior five earnings events all showing positive next-day moves.
Over recent earnings cycles, Precigen has moved from a development-stage RRP program to a commercial story. Prior updates highlighted FDA approval of PAPZIMEOS, growing patient hub enrollment, and rising cash balances, alongside expectations to reach cash flow break-even by end of 2026. Earlier releases focused on PRGN-2012 clinical data, priority review status, and capital raises to extend runway. Today’s Q1 2026 results, featuring PAPZIMEOS revenues and cash plus investments of $56.7M, fit into this transition to a revenue-driven profile.
Key Terms
non-replicating adenoviral vector-based immunotherapy medical
J-code regulatory
Marketing Authorization Application regulatory
orphan drug designation regulatory
Phase 2 clinical trials medical
pivotal trial medical
vector shedding medical
cooperative research and development agreement regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
- PAPZIMEOS™ launch gaining strong momentum with
$21.6 million - Patient hub enrollment continues to gain traction, with approximately 400 patients currently enrolled; a notable
25% of which are from the community setting, underscoring the breadth of PAPZIMEOS's reach and ease of administration - Updated durability of response data for PAPZIMEOS will be presented at the upcoming ASCO Annual Meeting
- RRP Awareness Day will be hosted alongside the Recurrent Respiratory Papillomatosis Foundation on June 11 for the third consecutive year, reflecting the Company's ongoing commitment to the recurrent respiratory papillomatosis (RRP) community
- The Company continues to advance PRGN-2009 in HPV-associated cancers and plans to provide an AdenoVerse® pipeline update by end of year
- Cash, cash equivalents, and investments totaled
$56.7 million - Conference call scheduled for 4:30 PM ET today
"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
KEY PROGRAM HIGHLIGHTS
PAPZIMEOS™: First-line Standard of Care for the Treatment of Adults with RRP
PAPZIMEOS (zopapogene imadenovec-drba) is a non-replicating adenoviral vector-based immunotherapy designed to generate an immune response directed against HPV 6 and HPV 11 proteins in patients with RRP. In August 2025, the US Food and Drug Administration (FDA) granted full approval of PAPZIMEOS with a broad label for the treatment of adults with RRP. PAPZIMEOS is the first and only FDA-approved therapy for the treatment of adults with RRP and the first treatment that addresses the root cause of RRP.
- National prescribing growth: PAPZIMEOS is being prescribed nationwide across both major medical centers and community practices, with patients spanning a range of disease severities actively receiving treatment. Building on strong community practice demand, the Company's target footprint has been expanded beyond the initial list, with increased engagement across community practices reflecting the broad interest seen since the full deployment of the PAPZIMEOS field team in September 2025.
- Patient hub enrollment: Enrollment in Precigen's patient hub reached approximately 400 registered patients, reflecting robust and growing demand from both patients and physicians. Notably,
25% of hub-enrolled patients are from the community setting, underscoring the broad reach of PAPZIMEOS beyond academic and major centers and reinforcing that PAPZIMEOS can be effectively integrated into routine clinical practice beyond major centers. Beyond hub enrollment, the Company's field teams continue to identify additional patients outside the hub, further underscoring the breadth of unmet need and commercial opportunity in the RRP community. - Positive payer coverage: PAPZIMEOS has private health plan coverage spanning approximately 215 million US lives, including the significant majority of leading insurers. With additional coverage under Medicare and Medicaid, PAPZIMEOS is accessible to an estimated 297 million US lives, or over
90% of insured lives in the US, reflecting broad and growing payer support for the therapy. - Permanent J-code accelerating site activations and patient access: Effective April 1, 2026, the Centers for Medicare and Medicaid Services assigned a permanent J-code (J3404) to PAPZIMEOS, and early indicators suggest this is already streamlining site activations. J-codes are standardized reimbursement codes that enable healthcare providers to bill government and commercial insurers for physician-administered therapies, and the permanent J-code designation is expected to further simplify claims processing and facilitate broader patient access across both medical centers and community practices.
- PAPZIMEOS recommended as standard of care first-line treatment: In January 2026, an expert position paper sponsored and published by the Recurrent Respiratory Papillomatosis Foundation and authored by 16 leading physicians in the field of RRP recommended PAPZIMEOS as the new standard of care first-line treatment for adults with RRP in the US.
- Upcoming ASCO clinical presentation: The Company will present updated durability of response data at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting taking place in
Chicago from May 29 to June 2, 2026, with a presentation titled "Zopapogene imadenovec-drba, a novel non-replicating adenoviral vector-based immunotherapy: Effects on complete and durable responses in recurrent respiratory papillomatosis pivotal trial." - Strong presence at key medical and scientific meetings: At AAO-HNSF 2025, SITC 2025, EUROGIN 2026, and COSM 2026, the Company presented long-term durable complete responses with PAPZIMEOS, and at ISPOR Europe 2025, the Company published data demonstrating the substantial healthcare resource utilization and patient-reported quality-of-life burden of RRP, underscoring the disease's significant clinical, economic, and human impact.
- Redosing study enrolling patients: The Company's open-label study to evaluate safety, vector shedding, and retreatment efficacy of zopapogene imadenovec-drba in adults with RRP is currently enrolling (clinical trial identifier: NCT06538480).
- MAA under review by the EMA: Following submission in November 2025, the Marketing Authorization Application for PAPZIMEOS for the treatment of adults with RRP was validated by the European Medicines Agency and is under review. PAPZIMEOS was granted orphan drug designation by the European Commission.
- RRP Awareness Day 2026: For the third consecutive year, Precigen will collaborate with the Recurrent Respiratory Papillomatosis Foundation to co-host RRP Awareness Day on June 11. The annual initiative is dedicated to educating the public and medical community about RRP by amplifying the voices of patients, caregivers, advocates, and the healthcare community supporting them.
PRGN-2009 AdenoVerse® Immunotherapy in HPV-associated Cancers
PRGN-2009 is an investigational AdenoVerse immunotherapy designed to activate the immune system to recognize and target HPV-associated cancers.
- PRGN-2009 Phase 2 clinical trials under a cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI) in newly diagnosed HPV-associated oropharyngeal cancer are ongoing.
- A multicenter Phase 2 clinical trial of PRGN-2009 in combination with pembrolizumab in recurrent/metastatic cervical cancer is ongoing.
- The Company plans to highlight progress across its AdenoVerse portfolio, including an update on PRGN-2009, by end of year.
FINANCIAL HIGHLIGHTS
"We are pleased with the launch performance of PAPZIMEOS, recognizing
First Quarter 2026 Financial Results Compared to Prior Year Period
Total revenues increased by
R&D expenses decreased by
Selling, general, and administrative (SG&A) expenses increased by
Total other expense, net, decreased by
Net loss 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 cash flow break-even, and the Company's ability to commence clinical studies or complete ongoing clinical studies for the Company's clinical and pre-clinical stage candidates. The Company has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. For further information on potential risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in the Company's most recent Annual Report on Form 10-K and subsequent reports filed with the Securities and Exchange Commission.
Investor Contact:
Steven M. Harasym
Tel: +1 (202) 365-2563
investors@precigen.com
Media Contact:
Donelle M. Gregory
press@precigen.com
Precigen, Inc. and Subsidiaries Consolidated Balance Sheets (Unaudited) | |||
(Amounts in thousands) | March 31, 2026 | December 31, 2025 | |
Assets | |||
Current assets | |||
Cash and cash equivalents | $ 7,480 | $ 30,234 | |
Short-term investments | 48,766 | 67,624 | |
Receivables | |||
Trade, net | 26,403 | 3,916 | |
Other | 302 | 446 | |
Inventory | 14,725 | 9,581 | |
Prepaid expenses and other | 3,996 | 3,434 | |
Total current assets | 101,672 | 115,235 | |
Long-term investments | 489 | 2,511 | |
Property, plant and equipment, net | 13,219 | 13,758 | |
Intangible assets, net | 2,864 | 3,182 | |
Goodwill | 15,232 | 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.