{"success":true,"data":{"pressRelease":{"id":"108460","rtpr_id":"nPn8bWfs7a","ticker":"PGEN","exchange":"NASDAQ","all_tickers":["PGEN"],"title":"Precigen Reports Second Quarter 2026 Financial Results Highlighted by Accelerating PAPZIMEOS Revenue Growth","author":"PR Newswire","published_at":"2026-08-04T20:01:00.882Z","article_body":"Precigen Reports Second Quarter 2026 Financial Results Highlighted by Accelerating PAPZIMEOS Revenue Growth\n\nPR Newswire\n\nGERMANTOWN, Md., Aug. 4, 2026\n\n * PAPZIMEOS(® )net revenue of $53.1 million in the second quarter of 2026, more\nthan double the prior quarter, reflects accelerating commercial momentum and\nbroad US adoption\n * PAPZIMEOS revenue propelled the Company to quarterly profitability\n * Cash, cash equivalents, and investments totaled $38.7 million as of June 30,\n2026, which together with proceeds from PAPZIMEOS revenue, is expected to\nsupport cash flow break-even by the end of 2026\n * PAPZIMEOS patient hub enrollment reached well over 500 patients across major\ncenters and community practices, demonstrating expanding reach and ease of\nadministration across treatment settings\n * FDA granted PAPZIMEOS seven-year market exclusivity, providing long-term\nprotection against prospective competition\n * Conference call scheduled for 4:30 PM ET today\nGERMANTOWN, Md., Aug. 4, 2026 /PRNewswire/ -- Precigen, Inc.\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4744513-1&h=4047411658&u=https%3A%2F%2Fprecigen.com%2F&a=Precigen%2C+Inc.)\n (Nasdaq: PGEN), a commercial-stage biopharmaceutical company specializing in\nthe advancement of innovative precision medicines to improve the lives of\npatients, today announced second quarter 2026 financial results and business\nupdates.\n\n\"We delivered a historic second quarter, with the rapid adoption of PAPZIMEOS\ndemonstrating the strength of our groundbreaking science and innovative\ncommercial strategy,\" said Helen Sabzevari, PhD, President and CEO of\nPrecigen. \"This momentum provides a strong foundation for our next phase of\ngrowth as we work to expand PAPZIMEOS globally and into the pediatric\npopulation. PAPZIMEOS demonstrates the AdenoVerse platform's ability to target\nHPV-associated diseases. We are building on that validated capability by\nadvancing PRGN-2009 in HPV-driven cancers, with a pipeline update expected by\nyear-end. With growing commercial momentum, a validated platform, and multiple\nopportunities ahead, we believe Precigen is well positioned to deliver\nsustained value for patients across various indications, the broader\nhealthcare community, and our shareholders.\"\n\n\"We continue to see the key elements of the PAPZIMEOS commercial launch drive\nrevenue growth: 100% field engagement with our initial target accounts, active\npatient and HCP campaigns, a permanent J-code supporting access and site\nactivations, payer coverage across nearly all insured US lives, growing\nphysician consensus reflected in a RRP position paper, and continued patient\nhub enrollments,\" said Phil Tennant, Chief Commercial Officer of Precigen.\n\"This progress translated into strong quarterly revenue growth and increasing\nadoption across major medical centers and community practices as PAPZIMEOS\nbecomes established as a new standard of care for adults with RRP. We remain\nfocused on converting demand into treated patients and further expanding\naccess to PAPZIMEOS across the RRP community.\"\n\nKEY PROGRAM HIGHLIGHTS\n\nPAPZIMEOS(®): First-line Standard of Care for the Treatment of Adults with\nRRP\nPAPZIMEOS (zopapogene imadenovec-drba) is a non-replicating adenoviral\nvector-based immunotherapy designed to generate an immune response directed\nagainst HPV 6 and HPV 11 proteins in patients with recurrent respiratory\npapillomatosis (RRP). PAPZIMEOS has been approved by the US Food and Drug\nAdministration (FDA) for the treatment of adults with RRP.\n\n * Broad US adoption: Well over 500 patients have registered through Precigen's\npatient hub, with additional patients outside of the hub being identified and\nreceiving treatment as institutions support patient access directly and\nindependently.\n * Market exclusivity: PAPZIMEOS was granted seven years of market exclusivity\nby the FDA, providing long-term protection against prospective competition.\nPAPZIMEOS remains the first and only approved therapy for adults with RRP and\nthe only treatment designed to target the underlying cause of the disease.\n * Broad payer coverage: PAPZIMEOS has payer coverage across approximately 315\nmillion US lives through private health plans, Medicare, and Medicaid,\nrepresenting nearly 100% of insured lives nationwide.\n * Permanent J-code: The Centers for Medicare and Medicaid Services assigned\npermanent J-code, J3404, to PAPZIMEOS, effective April 1, 2026. The J-code\nprovides a standard pathway for reimbursement, helps institutions process\nclaims more efficiently, and reduces uncertainty for sites that are still\nbuilding PAPZIMEOS into their workflows.\n * First-line standard of care: An expert position paper sponsored and published\nby the Recurrent Respiratory Papillomatosis Foundation and authored by 16\nleading RRP physicians recommended PAPZIMEOS as the first-line standard of\ncare for adults with RRP in the United States.\n * Redosing study enrolling patients: The Company's open-label study to evaluate\nredosing efficacy of zopapogene imadenovec in adults with RRP is currently\nenrolling (clinical trial identifier:\nNCT06538480\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4744513-1&h=3035580827&u=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT06538480%3Fterm%3Dprgn-2012%26viewType%3DCard%26rank%3D2&a=NCT06538480)\n\n).\n * MAA under review by the EMA: The European Medicines Agency (EMA) has\nvalidated and is reviewing the Marketing Authorization Application (MAA)\nsubmitted in November 2025 for zopapogene imadenovec for the treatment of\nadults with RRP. PAPZIMEOS has been granted\norphan drug designation\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4744513-1&h=1830104361&u=https%3A%2F%2Finvestors.precigen.com%2Fnews-releases%2Fnews-release-details%2Fprecigen-receives-orphan-drug-designation-prgn-2012-treatment&a=orphan+drug+designation)\n\n from the European Commission.\nPRGN-2009 AdenoVerse(®) Immunotherapy in HPV-associated Cancers\nPRGN-2009 is an investigational AdenoVerse immunotherapy designed to activate\nthe immune system to recognize and target HPV-associated cancers.\n\n * PRGN-2009 Phase 2 clinical trials under a cooperative research and development\nagreement (CRADA) with the National Cancer Institute (NCI) in newly diagnosed\nHPV-associated oropharyngeal cancer are ongoing.\n * A multicenter Phase 2 clinical trial of PRGN-2009 in combination with\npembrolizumab in recurrent/metastatic cervical cancer is ongoing.\n * The Company plans to provide an update on progress across the AdenoVerse\nportfolio, including PRGN-2009, by the end of the year.\nFINANCIAL RESULTS\n\n\"We are thrilled to report that Precigen achieved profitability in the second\nquarter, marking a significant milestone for the company. Net income was\ndriven by strong PAPZIMEOS revenue of $53.1 million. As we progress through\nthe third quarter of 2026, we are seeing continued growth in PAPZIMEOS\ndemand,\" said Harry Thomasian Jr., Chief Financial Officer of Precigen. \"Based\nupon our current revenue trajectory and present financial forecast, we\ncontinue to believe that our current cash position and anticipated cash to be\nreceived from PAPZIMEOS sales will fund operations through cash flow\nbreak-even by the end of 2026.\"\n\nSecond Quarter 2026 Financial Results Compared to Prior Year Period\nTotal revenues were $55.0 million for the three months ended June 30, 2026, an\nincrease of $54.1 million compared to the three months ended June 30, 2025.\nThe significant increase in total revenues was primarily due to the recording\nof commercial sales of PAPZIMEOS. Revenues related to the sale of PAPZIMEOS\nfor the three months ended June 30, 2026 were $53.1 million.\n\nCost of products and services increased by $1.7 million, compared to the three\nmonths ended June 30, 2025, almost entirely due to costs related to the\nrecording of commercial sales of PAPZIMEOS following its FDA approval in\nAugust 2025. Prior to regulatory approval, costs associated with the\nproduction of PAPZIMEOS were expensed as research and development in\naccordance with the Company's accounting policy. Upon FDA approval and the\ncommencement of commercial sales, these costs are now capitalized as inventory\nand recognized in cost of product and services as product is sold.\n\nR&D expenses decreased by $4.2 million, compared to the three months ended\nJune 30, 2025, primarily due to the change in the accounting treatment of\nPAPZIMEOS manufacturing costs. The Company expects that R&D expenses will\nincrease as the year progresses.\n\nSG&A expenses increased by $6.1 million, compared to the three months\nended June 30, 2025. This increase was primarily driven by commercial\nactivities related to PAPZIMEOS following its FDA approval in August 2025. The\nhigher expenses reflect increased costs to support commercialization, expanded\nmarketing and promotional activities to drive product awareness and adoption,\nand increased personnel costs, including stock compensation expense.\n\nIn the three months ended June 30, 2025, the Company recorded $3.9 million in\nimpairment related to its Exemplar reporting unit with no comparable charge in\nthe second quarter of 2026.\n\nTotal other expense, net was $2.6 million for the three months ended June 30,\n2026 compared to other income, net of $5.1 million for the three months ended\nJune 30, 2025, a change of $7.7 million. This change was primarily\nattributable to the absence of a $4.5 million gain related to the decrease in\nthe fair value of warrant liabilities that was recorded in the prior-year\nperiod. The remaining change primarily relates to an increase of $3.0 million\nin interest expense related to long term debt that originated in the third\nquarter of 2025.\n\nNet income was $20.1 million, or $0.06 per basic and $0.05 per diluted share\nfor the three months ended June 30, 2026, compared to a net loss of $26.6\nmillion, or $(0.09) per basic and diluted share, for the three months ended\nJune 30, 2025.\n\nFirst Six Months 2026 Financial Results Compared to Prior Year Period\nTotal revenues were $78.2 million for the six months ended June 30, 2026, an\nincrease of $76.0 million compared to the six months ended June 30, 2025. The\nsignificant increase in total revenues was primarily due to the recording of\ncommercial sales of PAPZIMEOS. Revenues related to the sale of PAPZIMEOS for\nthe six months ended June 30, 2026 were $74.7 million.\n\nCost of products and services increased by $3.2 million, compared to the six\nmonths ended June 30, 2025, almost entirely due to costs related to the\nrecording of commercial sales of PAPZIMEOS following its FDA approval in\nAugust 2025. Prior to regulatory approval, costs associated with the\nproduction of PAPZIMEOS were expensed as research and development in\naccordance with the Company's accounting policy. Upon FDA approval and the\ncommencement of commercial sales, these costs are now capitalized as inventory\nand recognized in cost of product and services as product is sold.\n\nR&D expenses decreased by $9.0 million, compared to the six months ended\nJune 30, 2025, primarily due to the change in the accounting treatment of\nPAPZIMEOS manufacturing costs. The Company expects that R&D expenses will\nincrease as the year progresses.\n\nSG&A expenses increased by $14.8 million, compared to the six months ended\nJune 30, 2025. This increase was primarily driven by commercial activities\nrelated to PAPZIMEOS following its FDA approval in August 2025. The higher\nexpenses reflect increased costs to support commercialization, expanded\nmarketing and promotional activities to drive product awareness and adoption,\nand increased personnel costs, including stock compensation expense.\n\nIn the six months ended June 30, 2025, the Company recorded $3.9 million in\nimpairment related to its Exemplar reporting unit with no comparable charge in\nthe six months ended June 30, 2026.\n\nTotal other expense, net decreased by $21.9 million, compared to the six\nmonths ended June 30, 2025. This decrease was primarily attributable to the\nabsence of a $28.0 million charge related to the increase in the fair value of\nwarrant liabilities that was recorded in the prior-year period. The remaining\nchange (an increase in other expense) primarily relates to an increase of $5.9\nmillion in interest expense related to long-term debt that was entered into in\nthe third quarter of 2025.\n\nNet income was $12.1 million, or $0.03 per basic and diluted share for the\nsix months ended June 30, 2026, compared to a net loss of $80.8 million,\nor $(0.27) per basic and diluted share, for the six months ended June 30,\n2025.\n\nPrecigen: Advancing Medicine with Precision(®\n)Precigen (Nasdaq: PGEN) is a commercial-stage biopharmaceutical company\nspecializing in the advancement of innovative precision medicines to address\ndifficult-to-treat diseases with high unmet patient need. Precigen is\ndedicated to advancing scientific breakthroughs from proof-of-concept through\ncommercialization. With a strong commitment to innovation, Precigen is\ndeveloping a robust pipeline of differentiated therapies across its core\ntherapeutic areas of immuno-oncology, autoimmune disorders, and infectious\ndiseases. For more information about Precigen, visit www.precigen.com\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4744513-1&h=3135718582&u=http%3A%2F%2Fwww.precigen.com%2F&a=www.precigen.com)\n or follow us on LinkedIn\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4744513-1&h=2526525941&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fprecigen%2F&a=LinkedIn)\n or YouTube\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4744513-1&h=2363766202&u=https%3A%2F%2Fwww.youtube.com%2Fchannel%2FUCbd51C9ftUDEnSfbheMjF2Q&a=YouTube)\n.\n\nTrademarks\nPrecigen, PAPZIMEOS, AdenoVerse, and Advancing Medicine with Precision are\ntrademarks of Precigen and/or its affiliates. Other names may be trademarks\nof their respective owners.\n\nCautionary Statement Regarding Forward-Looking Statements\nThis press release contains \"forward-looking\" statements within the meaning of\nthe safe harbor provisions of the US Private Securities Litigation Reform Act\nof 1995. Forward-looking statements can be identified by words such as:\n\"anticipate,\" \"intend,\" \"plan,\" \"goal,\" \"seek,\" \"believe,\" \"project,\"\n\"estimate,\" \"expect,\" \"strategy,\" \"future,\" \"likely,\" \"may,\" \"should,\" \"will\"\nand similar references to future periods. These statements are subject to\nnumerous risks and uncertainties that could cause actual results to differ\nmaterially from what the Company expects. Examples of forward-looking\nstatements include, among others, information relating to the Company's\nbusiness and business plans, the success of efforts to commercialize\nPAPZIMEOS® (zopapogene imadenovec-drba) for the treatment of recurrent\nrespiratory papillomatosis (RRP) in adults including the revenue that the\nCompany expects to realize from such efforts, the Company's ability to\nsuccessfully obtain foreign regulatory approvals for PAPZIMEOS, expectations\nabout the safety and efficacy of PAPZIMEOS, the ability of PAPZIMEOS to treat\nRRP, the Company's future financial and operational results including the\nCompany's ability to reach quarterly profitability and cash flow break-even,\nand the Company's ability to commence clinical studies or complete ongoing\nclinical studies for the Company's clinical and pre-clinical stage candidates.\nThe Company has no obligation to provide any updates to these forward-looking\nstatements even if its expectations change. All forward-looking statements are\nexpressly qualified in their entirety by this cautionary statement. For\nfurther information on potential risks and uncertainties, and other important\nfactors, any of which could cause the Company's actual results to differ from\nthose contained in the forward-looking statements, see the section entitled\n\"Risk Factors\" in the Company's most recent Annual Report on Form 10-K and\nsubsequent reports filed with the Securities and Exchange Commission.\n\nInvestor Contact:\nSteven M. Harasym\nTel: +1 (202) 365-2563\ninvestors@precigen.com (mailto:investors@precigen.com)\n\nMedia Contact:\nDonelle M. Gregory\npress@precigen.com (mailto:press@precigen.com)\n Precigen, Inc. and Subsidiaries\n Consolidated Balance Sheets\n (Unaudited)\n (Amounts in thousands) June 30, 2026 December 31, 2025\n Assets\n Current assets\n Cash and cash equivalents $ 16,329 $ 30,234\n Short-term investments 21,879 67,624\n Receivables\n Trade, net 71,866 3,916\n Other 178 446\n Inventory 20,245 9,581\n Prepaid expenses and other 3,887 3,434\n Total current assets 134,384 115,235\n Long-term investments 490 2,511\n Property, plant and equipment, net 12,802 13,758\n Intangible assets, net 2,545 3,182\n Goodwill 15,232 15,232\n Right-of-use assets 4,135 4,679\n Other assets 708 908\n Total assets $ 170,296 $ 155,505\n Liabilities and Shareholders' Equity\n Current liabilities\n Accounts payable $ 5,304 $ 11,985\n Accrued compensation and benefits 6,498 10,199\n Other accrued liabilities 16,212 10,993\n Indemnification accruals — 2,476\n Deferred revenue 284 517\n Current portion of lease liabilities 1,055 1,136\n Total current liabilities 29,353 37,306\n Long-term debt 93,880 93,174\n Lease liabilities, net of current portion 3,410 3,980\n Other long-term liabilities 77 134\n Total liabilities 126,720 134,594\n Shareholders' equity\n Additional paid-in capital 2,372,811 2,362,252\n Accumulated deficit (2,329,206) (2,341,348)\n Accumulated other comprehensive (loss) income (29) 7\n Total shareholders' equity 43,576 20,911\n Total liabilities and shareholders' equity $ 170,296 $ 155,505\n\n \n Precigen, Inc. and Subsidiaries\n Consolidated Statement of Operations\n (Unaudited)\n (Amounts in thousands, except share Three Months Ended Six Months Ended\n June 30, June 30,\n and per share data) 2026 2025 2026 2025\n Revenues\n Product revenues, net $ 53,262 $ 41 $ 75,090 $ 244\n Service revenues 1,716 815 3,140 1,953\n Total revenues 54,978 856 78,230 2,197\n Operating Expenses\n Cost of products and services 2,805 1,092 5,364 2,192\n Research and development 7,282 11,488 12,920 21,966\n Selling, general and administrative 22,249 16,133 43,298 28,492\n Impairment of goodwill — 3,907 — 3,907\n Total operating expenses 32,336 32,620 61,582 56,557\n Operating income (loss) 22,642 (31,764) 16,648 (54,360)\n Other Income (Expense), Net\n Change in fair value of warrant liabilities — 4,460 — (28,021)\n Interest expense (2,953) — (5,861) (1)\n Interest income 366 696 1,049 1,614\n Other income (expense), net 16 (31) 306 (24)\n Total other income (expense), net (2,571) 5,125 (4,506) (26,432)\n Income (loss) before income taxes 20,071 (26,639) 12,142 (80,792)\n Income tax expense — (3) — (3)\n Net income (loss) $ 20,071 $ (26,642) $ 12,142 $ (80,795)\n Net income (loss) per share\n Net income (loss) per share, basic $ 0.06 $ (0.09) $ 0.03 $ (0.27)\n Net income (loss) per share, diluted $ 0.05 $ (0.09) $ 0.03 $ (0.27)\n Weighted average shares outstanding, basic 356,893,568 296,434,726 355,599,477 295,164,303\n Weighted average shares outstanding, diluted 413,686,865 296,434,726 412,552,647 295,164,303\n\nView original content to download\nmultimedia:https://www.prnewswire.com/news-releases/precigen-reports-second-quarter-2026-financial-results-highlighted-by-accelerating-papzimeos-revenue-growth-302842911.html\n(https://www.prnewswire.com/news-releases/precigen-reports-second-quarter-2026-financial-results-highlighted-by-accelerating-papzimeos-revenue-growth-302842911.html)\n\nSOURCE Precigen, Inc.\n\n\n\nPhoto: \nhttps://mmx.prnewswire.com/media/MS476386/Precigen-Logo.jpg?id=OA2822209\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved.","article_body_html":"","raw_payload":{"data":{"id":"nPn8bWfs7a","title":"Precigen Reports Second Quarter 2026 Financial Results Highlighted by Accelerating PAPZIMEOS Revenue Growth","author":"PR Newswire","ticker":"PGEN","created":"2026-08-04T20:01:00.882Z","tickers":["PGEN"],"exchange":"NASDAQ","article_body":"Precigen Reports Second Quarter 2026 Financial Results Highlighted by Accelerating PAPZIMEOS Revenue Growth\n\nPR Newswire\n\nGERMANTOWN, Md., Aug. 4, 2026\n\n * PAPZIMEOS(® )net revenue of $53.1 million in the second quarter of 2026, more\nthan double the prior quarter, reflects accelerating commercial momentum and\nbroad US adoption\n * PAPZIMEOS revenue propelled the Company to quarterly profitability\n * Cash, cash equivalents, and investments totaled $38.7 million as of June 30,\n2026, which together with proceeds from PAPZIMEOS revenue, is expected to\nsupport cash flow break-even by the end of 2026\n * PAPZIMEOS patient hub enrollment reached well over 500 patients across major\ncenters and community practices, demonstrating expanding reach and ease of\nadministration across treatment settings\n * FDA granted PAPZIMEOS seven-year market exclusivity, providing long-term\nprotection against prospective competition\n * Conference call scheduled for 4:30 PM ET today\nGERMANTOWN, Md., Aug. 4, 2026 /PRNewswire/ -- Precigen, Inc.\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4744513-1&h=4047411658&u=https%3A%2F%2Fprecigen.com%2F&a=Precigen%2C+Inc.)\n (Nasdaq: PGEN), a commercial-stage biopharmaceutical company specializing in\nthe advancement of innovative precision medicines to improve the lives of\npatients, today announced second quarter 2026 financial results and business\nupdates.\n\n\"We delivered a historic second quarter, with the rapid adoption of PAPZIMEOS\ndemonstrating the strength of our groundbreaking science and innovative\ncommercial strategy,\" said Helen Sabzevari, PhD, President and CEO of\nPrecigen. \"This momentum provides a strong foundation for our next phase of\ngrowth as we work to expand PAPZIMEOS globally and into the pediatric\npopulation. PAPZIMEOS demonstrates the AdenoVerse platform's ability to target\nHPV-associated diseases. We are building on that validated capability by\nadvancing PRGN-2009 in HPV-driven cancers, with a pipeline update expected by\nyear-end. With growing commercial momentum, a validated platform, and multiple\nopportunities ahead, we believe Precigen is well positioned to deliver\nsustained value for patients across various indications, the broader\nhealthcare community, and our shareholders.\"\n\n\"We continue to see the key elements of the PAPZIMEOS commercial launch drive\nrevenue growth: 100% field engagement with our initial target accounts, active\npatient and HCP campaigns, a permanent J-code supporting access and site\nactivations, payer coverage across nearly all insured US lives, growing\nphysician consensus reflected in a RRP position paper, and continued patient\nhub enrollments,\" said Phil Tennant, Chief Commercial Officer of Precigen.\n\"This progress translated into strong quarterly revenue growth and increasing\nadoption across major medical centers and community practices as PAPZIMEOS\nbecomes established as a new standard of care for adults with RRP. We remain\nfocused on converting demand into treated patients and further expanding\naccess to PAPZIMEOS across the RRP community.\"\n\nKEY PROGRAM HIGHLIGHTS\n\nPAPZIMEOS(®): First-line Standard of Care for the Treatment of Adults with\nRRP\nPAPZIMEOS (zopapogene imadenovec-drba) is a non-replicating adenoviral\nvector-based immunotherapy designed to generate an immune response directed\nagainst HPV 6 and HPV 11 proteins in patients with recurrent respiratory\npapillomatosis (RRP). PAPZIMEOS has been approved by the US Food and Drug\nAdministration (FDA) for the treatment of adults with RRP.\n\n * Broad US adoption: Well over 500 patients have registered through Precigen's\npatient hub, with additional patients outside of the hub being identified and\nreceiving treatment as institutions support patient access directly and\nindependently.\n * Market exclusivity: PAPZIMEOS was granted seven years of market exclusivity\nby the FDA, providing long-term protection against prospective competition.\nPAPZIMEOS remains the first and only approved therapy for adults with RRP and\nthe only treatment designed to target the underlying cause of the disease.\n * Broad payer coverage: PAPZIMEOS has payer coverage across approximately 315\nmillion US lives through private health plans, Medicare, and Medicaid,\nrepresenting nearly 100% of insured lives nationwide.\n * Permanent J-code: The Centers for Medicare and Medicaid Services assigned\npermanent J-code, J3404, to PAPZIMEOS, effective April 1, 2026. The J-code\nprovides a standard pathway for reimbursement, helps institutions process\nclaims more efficiently, and reduces uncertainty for sites that are still\nbuilding PAPZIMEOS into their workflows.\n * First-line standard of care: An expert position paper sponsored and published\nby the Recurrent Respiratory Papillomatosis Foundation and authored by 16\nleading RRP physicians recommended PAPZIMEOS as the first-line standard of\ncare for adults with RRP in the United States.\n * Redosing study enrolling patients: The Company's open-label study to evaluate\nredosing efficacy of zopapogene imadenovec in adults with RRP is currently\nenrolling (clinical trial identifier:\nNCT06538480\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4744513-1&h=3035580827&u=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT06538480%3Fterm%3Dprgn-2012%26viewType%3DCard%26rank%3D2&a=NCT06538480)\n\n).\n * MAA under review by the EMA: The European Medicines Agency (EMA) has\nvalidated and is reviewing the Marketing Authorization Application (MAA)\nsubmitted in November 2025 for zopapogene imadenovec for the treatment of\nadults with RRP. PAPZIMEOS has been granted\norphan drug designation\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4744513-1&h=1830104361&u=https%3A%2F%2Finvestors.precigen.com%2Fnews-releases%2Fnews-release-details%2Fprecigen-receives-orphan-drug-designation-prgn-2012-treatment&a=orphan+drug+designation)\n\n from the European Commission.\nPRGN-2009 AdenoVerse(®) Immunotherapy in HPV-associated Cancers\nPRGN-2009 is an investigational AdenoVerse immunotherapy designed to activate\nthe immune system to recognize and target HPV-associated cancers.\n\n * PRGN-2009 Phase 2 clinical trials under a cooperative research and development\nagreement (CRADA) with the National Cancer Institute (NCI) in newly diagnosed\nHPV-associated oropharyngeal cancer are ongoing.\n * A multicenter Phase 2 clinical trial of PRGN-2009 in combination with\npembrolizumab in recurrent/metastatic cervical cancer is ongoing.\n * The Company plans to provide an update on progress across the AdenoVerse\nportfolio, including PRGN-2009, by the end of the year.\nFINANCIAL RESULTS\n\n\"We are thrilled to report that Precigen achieved profitability in the second\nquarter, marking a significant milestone for the company. Net income was\ndriven by strong PAPZIMEOS revenue of $53.1 million. As we progress through\nthe third quarter of 2026, we are seeing continued growth in PAPZIMEOS\ndemand,\" said Harry Thomasian Jr., Chief Financial Officer of Precigen. \"Based\nupon our current revenue trajectory and present financial forecast, we\ncontinue to believe that our current cash position and anticipated cash to be\nreceived from PAPZIMEOS sales will fund operations through cash flow\nbreak-even by the end of 2026.\"\n\nSecond Quarter 2026 Financial Results Compared to Prior Year Period\nTotal revenues were $55.0 million for the three months ended June 30, 2026, an\nincrease of $54.1 million compared to the three months ended June 30, 2025.\nThe significant increase in total revenues was primarily due to the recording\nof commercial sales of PAPZIMEOS. Revenues related to the sale of PAPZIMEOS\nfor the three months ended June 30, 2026 were $53.1 million.\n\nCost of products and services increased by $1.7 million, compared to the three\nmonths ended June 30, 2025, almost entirely due to costs related to the\nrecording of commercial sales of PAPZIMEOS following its FDA approval in\nAugust 2025. Prior to regulatory approval, costs associated with the\nproduction of PAPZIMEOS were expensed as research and development in\naccordance with the Company's accounting policy. Upon FDA approval and the\ncommencement of commercial sales, these costs are now capitalized as inventory\nand recognized in cost of product and services as product is sold.\n\nR&D expenses decreased by $4.2 million, compared to the three months ended\nJune 30, 2025, primarily due to the change in the accounting treatment of\nPAPZIMEOS manufacturing costs. The Company expects that R&D expenses will\nincrease as the year progresses.\n\nSG&A expenses increased by $6.1 million, compared to the three months\nended June 30, 2025. This increase was primarily driven by commercial\nactivities related to PAPZIMEOS following its FDA approval in August 2025. The\nhigher expenses reflect increased costs to support commercialization, expanded\nmarketing and promotional activities to drive product awareness and adoption,\nand increased personnel costs, including stock compensation expense.\n\nIn the three months ended June 30, 2025, the Company recorded $3.9 million in\nimpairment related to its Exemplar reporting unit with no comparable charge in\nthe second quarter of 2026.\n\nTotal other expense, net was $2.6 million for the three months ended June 30,\n2026 compared to other income, net of $5.1 million for the three months ended\nJune 30, 2025, a change of $7.7 million. This change was primarily\nattributable to the absence of a $4.5 million gain related to the decrease in\nthe fair value of warrant liabilities that was recorded in the prior-year\nperiod. The remaining change primarily relates to an increase of $3.0 million\nin interest expense related to long term debt that originated in the third\nquarter of 2025.\n\nNet income was $20.1 million, or $0.06 per basic and $0.05 per diluted share\nfor the three months ended June 30, 2026, compared to a net loss of $26.6\nmillion, or $(0.09) per basic and diluted share, for the three months ended\nJune 30, 2025.\n\nFirst Six Months 2026 Financial Results Compared to Prior Year Period\nTotal revenues were $78.2 million for the six months ended June 30, 2026, an\nincrease of $76.0 million compared to the six months ended June 30, 2025. The\nsignificant increase in total revenues was primarily due to the recording of\ncommercial sales of PAPZIMEOS. Revenues related to the sale of PAPZIMEOS for\nthe six months ended June 30, 2026 were $74.7 million.\n\nCost of products and services increased by $3.2 million, compared to the six\nmonths ended June 30, 2025, almost entirely due to costs related to the\nrecording of commercial sales of PAPZIMEOS following its FDA approval in\nAugust 2025. Prior to regulatory approval, costs associated with the\nproduction of PAPZIMEOS were expensed as research and development in\naccordance with the Company's accounting policy. Upon FDA approval and the\ncommencement of commercial sales, these costs are now capitalized as inventory\nand recognized in cost of product and services as product is sold.\n\nR&D expenses decreased by $9.0 million, compared to the six months ended\nJune 30, 2025, primarily due to the change in the accounting treatment of\nPAPZIMEOS manufacturing costs. The Company expects that R&D expenses will\nincrease as the year progresses.\n\nSG&A expenses increased by $14.8 million, compared to the six months ended\nJune 30, 2025. This increase was primarily driven by commercial activities\nrelated to PAPZIMEOS following its FDA approval in August 2025. The higher\nexpenses reflect increased costs to support commercialization, expanded\nmarketing and promotional activities to drive product awareness and adoption,\nand increased personnel costs, including stock compensation expense.\n\nIn the six months ended June 30, 2025, the Company recorded $3.9 million in\nimpairment related to its Exemplar reporting unit with no comparable charge in\nthe six months ended June 30, 2026.\n\nTotal other expense, net decreased by $21.9 million, compared to the six\nmonths ended June 30, 2025. This decrease was primarily attributable to the\nabsence of a $28.0 million charge related to the increase in the fair value of\nwarrant liabilities that was recorded in the prior-year period. The remaining\nchange (an increase in other expense) primarily relates to an increase of $5.9\nmillion in interest expense related to long-term debt that was entered into in\nthe third quarter of 2025.\n\nNet income was $12.1 million, or $0.03 per basic and diluted share for the\nsix months ended June 30, 2026, compared to a net loss of $80.8 million,\nor $(0.27) per basic and diluted share, for the six months ended June 30,\n2025.\n\nPrecigen: Advancing Medicine with Precision(®\n)Precigen (Nasdaq: PGEN) is a commercial-stage biopharmaceutical company\nspecializing in the advancement of innovative precision medicines to address\ndifficult-to-treat diseases with high unmet patient need. Precigen is\ndedicated to advancing scientific breakthroughs from proof-of-concept through\ncommercialization. With a strong commitment to innovation, Precigen is\ndeveloping a robust pipeline of differentiated therapies across its core\ntherapeutic areas of immuno-oncology, autoimmune disorders, and infectious\ndiseases. For more information about Precigen, visit www.precigen.com\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4744513-1&h=3135718582&u=http%3A%2F%2Fwww.precigen.com%2F&a=www.precigen.com)\n or follow us on LinkedIn\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4744513-1&h=2526525941&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fprecigen%2F&a=LinkedIn)\n or YouTube\n(https://edge.prnewswire.com/c/link/?t=0&l=en&o=4744513-1&h=2363766202&u=https%3A%2F%2Fwww.youtube.com%2Fchannel%2FUCbd51C9ftUDEnSfbheMjF2Q&a=YouTube)\n.\n\nTrademarks\nPrecigen, PAPZIMEOS, AdenoVerse, and Advancing Medicine with Precision are\ntrademarks of Precigen and/or its affiliates. Other names may be trademarks\nof their respective owners.\n\nCautionary Statement Regarding Forward-Looking Statements\nThis press release contains \"forward-looking\" statements within the meaning of\nthe safe harbor provisions of the US Private Securities Litigation Reform Act\nof 1995. Forward-looking statements can be identified by words such as:\n\"anticipate,\" \"intend,\" \"plan,\" \"goal,\" \"seek,\" \"believe,\" \"project,\"\n\"estimate,\" \"expect,\" \"strategy,\" \"future,\" \"likely,\" \"may,\" \"should,\" \"will\"\nand similar references to future periods. These statements are subject to\nnumerous risks and uncertainties that could cause actual results to differ\nmaterially from what the Company expects. Examples of forward-looking\nstatements include, among others, information relating to the Company's\nbusiness and business plans, the success of efforts to commercialize\nPAPZIMEOS® (zopapogene imadenovec-drba) for the treatment of recurrent\nrespiratory papillomatosis (RRP) in adults including the revenue that the\nCompany expects to realize from such efforts, the Company's ability to\nsuccessfully obtain foreign regulatory approvals for PAPZIMEOS, expectations\nabout the safety and efficacy of PAPZIMEOS, the ability of PAPZIMEOS to treat\nRRP, the Company's future financial and operational results including the\nCompany's ability to reach quarterly profitability and cash flow break-even,\nand the Company's ability to commence clinical studies or complete ongoing\nclinical studies for the Company's clinical and pre-clinical stage candidates.\nThe Company has no obligation to provide any updates to these forward-looking\nstatements even if its expectations change. All forward-looking statements are\nexpressly qualified in their entirety by this cautionary statement. For\nfurther information on potential risks and uncertainties, and other important\nfactors, any of which could cause the Company's actual results to differ from\nthose contained in the forward-looking statements, see the section entitled\n\"Risk Factors\" in the Company's most recent Annual Report on Form 10-K and\nsubsequent reports filed with the Securities and Exchange Commission.\n\nInvestor Contact:\nSteven M. Harasym\nTel: +1 (202) 365-2563\ninvestors@precigen.com (mailto:investors@precigen.com)\n\nMedia Contact:\nDonelle M. Gregory\npress@precigen.com (mailto:press@precigen.com)\n Precigen, Inc. and Subsidiaries\n Consolidated Balance Sheets\n (Unaudited)\n (Amounts in thousands) June 30, 2026 December 31, 2025\n Assets\n Current assets\n Cash and cash equivalents $ 16,329 $ 30,234\n Short-term investments 21,879 67,624\n Receivables\n Trade, net 71,866 3,916\n Other 178 446\n Inventory 20,245 9,581\n Prepaid expenses and other 3,887 3,434\n Total current assets 134,384 115,235\n Long-term investments 490 2,511\n Property, plant and equipment, net 12,802 13,758\n Intangible assets, net 2,545 3,182\n Goodwill 15,232 15,232\n Right-of-use assets 4,135 4,679\n Other assets 708 908\n Total assets $ 170,296 $ 155,505\n Liabilities and Shareholders' Equity\n Current liabilities\n Accounts payable $ 5,304 $ 11,985\n Accrued compensation and benefits 6,498 10,199\n Other accrued liabilities 16,212 10,993\n Indemnification accruals — 2,476\n Deferred revenue 284 517\n Current portion of lease liabilities 1,055 1,136\n Total current liabilities 29,353 37,306\n Long-term debt 93,880 93,174\n Lease liabilities, net of current portion 3,410 3,980\n Other long-term liabilities 77 134\n Total liabilities 126,720 134,594\n Shareholders' equity\n Additional paid-in capital 2,372,811 2,362,252\n Accumulated deficit (2,329,206) (2,341,348)\n Accumulated other comprehensive (loss) income (29) 7\n Total shareholders' equity 43,576 20,911\n Total liabilities and shareholders' equity $ 170,296 $ 155,505\n\n \n Precigen, Inc. and Subsidiaries\n Consolidated Statement of Operations\n (Unaudited)\n (Amounts in thousands, except share Three Months Ended Six Months Ended\n June 30, June 30,\n and per share data) 2026 2025 2026 2025\n Revenues\n Product revenues, net $ 53,262 $ 41 $ 75,090 $ 244\n Service revenues 1,716 815 3,140 1,953\n Total revenues 54,978 856 78,230 2,197\n Operating Expenses\n Cost of products and services 2,805 1,092 5,364 2,192\n Research and development 7,282 11,488 12,920 21,966\n Selling, general and administrative 22,249 16,133 43,298 28,492\n Impairment of goodwill — 3,907 — 3,907\n Total operating expenses 32,336 32,620 61,582 56,557\n Operating income (loss) 22,642 (31,764) 16,648 (54,360)\n Other Income (Expense), Net\n Change in fair value of warrant liabilities — 4,460 — (28,021)\n Interest expense (2,953) — (5,861) (1)\n Interest income 366 696 1,049 1,614\n Other income (expense), net 16 (31) 306 (24)\n Total other income (expense), net (2,571) 5,125 (4,506) (26,432)\n Income (loss) before income taxes 20,071 (26,639) 12,142 (80,792)\n Income tax expense — (3) — (3)\n Net income (loss) $ 20,071 $ (26,642) $ 12,142 $ (80,795)\n Net income (loss) per share\n Net income (loss) per share, basic $ 0.06 $ (0.09) $ 0.03 $ (0.27)\n Net income (loss) per share, diluted $ 0.05 $ (0.09) $ 0.03 $ (0.27)\n Weighted average shares outstanding, basic 356,893,568 296,434,726 355,599,477 295,164,303\n Weighted average shares outstanding, diluted 413,686,865 296,434,726 412,552,647 295,164,303\n\nView original content to download\nmultimedia:https://www.prnewswire.com/news-releases/precigen-reports-second-quarter-2026-financial-results-highlighted-by-accelerating-papzimeos-revenue-growth-302842911.html\n(https://www.prnewswire.com/news-releases/precigen-reports-second-quarter-2026-financial-results-highlighted-by-accelerating-papzimeos-revenue-growth-302842911.html)\n\nSOURCE Precigen, Inc.\n\n\n\nPhoto: \nhttps://mmx.prnewswire.com/media/MS476386/Precigen-Logo.jpg?id=OA2822209\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved."},"type":"article","timestamp":"2026-08-04T20:01:00.96454683Z","server_sent_at_ms":1785873660964},"received_at":"2026-08-04T20:01:01.037Z","source_url":"https://www.prnewswire.com/news-releases/precigen-reports-second-quarter-2026-financial-results-highlighted-by-accelerating-papzimeos-revenue-growth-302842911.html"},"analysis":{"id":"97472","press_release_id":"108460","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":[],"eventType":"earnings","narrative":"Precigen reported Q2 total revenue of $55.0 million, driven by $53.1 million in PAPZIMEOS net revenue which more than doubled from the prior quarter.\n\nThe company achieved profitability with net income of $20.1 million, or $0.05 per diluted share, compared to a net loss of $26.6 million in the prior-year period.\n\nManagement reiterated that current cash of $38.7 million and product sales will support operations through cash flow break-even by the end of 2026, bolstered by 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