PRGN-2009

PAPZIMEOS (zopapogene imadenovec-drba) received full approval by the FDA in August PAPZIMEOS launched with a broad label in the US as the first and only FDA-approved treatment for adults with RRP PAPZIMEOS is now available and shipping to prescribers in the US for the treatment of adults with RRP To date, over 100 patients have been registered in the PAPZIMEOS Patient Hub The Company has made significant progress with private health insurance coverage, with more than 100 million lives covered to date; PAPZIMEOS is now available through Medicare and Medicaid Rapid commercial launch execution underway with full deployment of the sales team in September and over 90% of target institutions engaged In October, the Company announced long-term follow-up results from the PAPZIMEOS pivotal clinical trial highlighting ongoing durable (median 36 months) complete responses without any additional treatment interventions In November, the Company submitted a Marketing Authorization Application to the European Medicines Agency for zopapogene imadenovec for the treatment of adults with RRP Cash, cash equivalents, and investments totaled $123.6 million as of September 30, 2025, which is expected to fund the Company's operations to cash flow break-even GERMANTOWN, Md., Nov. 13, 2025 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, today announced third quarter 2025 financial results and business updates. "FDA approval of PAPZIMEOS in August marked the beginning of a new era for adults living with RRP," said Helen Sabzevari, PhD, President and CEO of Precigen. "PAPZIMEOS is the first and only treatment for adults with RRP, with an excellent safety profile and unmatched efficacy based on the groundbreaking pivotal study that supported full FDA approval, granted ahead of the PDUFA action date. PAPZIMEOS is already available to prescribers, and demand from both physicians and patients has been exceptional. For the first time, adults with RRP have access to an emerging standard of care—the first therapy capable of breaking the relentless cycle of surgeries by targeting the root cause of the disease." "We are very encouraged by the strong early interest in PAPZIMEOS and the rapid pace of activation since approval in August and the deployment of our sales force in September," said Phil Tennant, Chief Commercial Officer of Precigen. "Patient identification has been outstanding, with prescribers and institutions actively working to bring PAPZIMEOS to their patients. To date, over 100 patients have already been registered in the PAPZIMEOS Patient Hub. In addition, a significantly larger number of patients have been identified through institutional patient hubs as potential candidates for treatment with PAPZIMEOS. Our team has swiftly mobilized the market: engaging over 90% of target institutions, advancing payer and formulary access, and driving broad educational and promotional outreach. These efforts have laid a firm foundation for PAPZIMEOS as the new standard of care for adults with RRP." "PAPZIMEOS represents a monumental shift in how we care for adults with RRP," said Dr. Simon R. Best, MD, Associate Professor of Otolaryngology-Head and Neck Surgery, Johns Hopkins University School of Medicine. "For the first time, we can offer adult patients a safe and effective treatment that addresses the underlying disease rather than repeatedly managing symptoms through endless surgeries. The durable patient outcomes from the pivotal trial are nothing short of remarkable, and it's clear PAPZIMEOS is poised to become the new standard of care for this debilitating condition." KEY PROGRAM AND COMPANY HIGHLIGHTS PAPZIMEOS™ (zopapogene imadenovec-drba) AdenoVerse® Immunotherapy for Adults with RRP PAPZIMEOS full approval: In August 2025, the US Food and Drug Administration (FDA) granted full approval of PAPZIMEOS with a broad label and no requirement for a confirmatory trial for the treatment of adults with recurrent respiratory papillomatosis (RRP). Approval was supported by the groundbreaking results from the Phase 1/2 pivotal study—the only study in RRP ever conducted with a prospectively defined statistical primary endpoint. PAPZIMEOS now available: Following FDA approval in August 2025, PAPZIMEOS is now commercially available and commercial product is shipping to prescribers in the US for the treatment of adults with RRP. Early adoption momentum: Rapid commercial launch execution is underway with over 90% of target institutions engaged since full deployment of the sales team in September. To date, over 100 patients have been registered in the PAPZIMEOS Patient Hub. Positive payer coverage: Private health insurance coverage is progressing rapidly with more than 100 million lives covered to date; PAPZIMEOS is also now available through Medicare and Medicaid. Long-term durability data published: The Company announced long-term follow-up results highlighting ongoing durable complete responses after treatment with PAPZIMEOS at the American Academy of Otolaryngology–Head and Neck Surgery Foundation (AAO-HNSF) 2025 Annual Meeting and the Society for Immunotherapy of Cancer (SITC) annual meeting 2025. As of the September 19, 2025 data cutoff: 15 out of 18 complete responders (83%) demonstrated continued complete response without any additional treatment interventions with a median follow-up of 36 months (range 27 to 37). Median duration of complete response has yet to be reached. Reduction in surgeries compared to the year prior to treatment with PAPZIMEOS was observed in 86% of patients in Year 1, 91% in Year 2, and 95% in Year 3. No new safety events observed during long-term follow-up. Healthcare resource utilization data published: The Company announced new data at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Europe 2025 showing that, above and beyond the impact of surgery, healthcare resource utilization is substantially higher in adults with RRP with significantly higher emergency and healthcare visits, opioid use, and mental health service needs, reflecting the substantial burden on the healthcare system. Quality of life data published: The Company announced new data at ISPOR Europe 2025 showing results from a survey of adult RRP patients highlighting the substantial impact of RRP on the patient journey and quality of life. RRP patients reported a substantial physical and mental health burden that impacts overall well-being, results in job losses and productivity declines, and lowers overall quality of life. Geographic expansion: The Company submitted a Marketing Authorization Application (MAA) for zopapogene imadenovec for the treatment of adults with RRP to the European Medicines Agency (EMA) in November 2025. PRGN-2009 AdenoVerse® Immunotherapy in HPV-associated Cancers PRGN-2009 is an investigational off-the-shelf 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. The Phase 2 randomized, open-label study of PRGN-2009 in combination with pembrolizumab in patients with HPV-associated recurrent/metastatic cervical cancer is ongoing with two additional clinical sites active in addition to NCI. FINANCIAL HIGHLIGHTS Cash, cash equivalents, and investments totaled $123.6 million as of September 30, 2025 which is expected to fund the Company's operations to cash flow break-even. In September 2025, the Company entered into a credit facility that provides up to $125 million of non-dilutive financing and received the first tranche of $100 million. "In the third quarter of 2025, we significantly increased investment in commercialization efforts to support the successful launch of PAPZIMEOS," said Harry Thomasian Jr., Chief Financial Officer of Precigen. "With the launch now underway, we are confident that we are well-equipped to maximize the impact of the historic PAPZIMEOS launch, drive ongoing commercialization of PAPZIMEOS, and support sustainable growth. Importantly, based upon our present forecast, we expect our current cash position to fund operations through cash flow break-even, representing a strong financial foundation as we continue to execute on our commercial and strategic objectives." Third Quarter 2025 Financial Results Compared to Prior Year Period Total revenues increased by $2.0 million compared to the three months ended September 30, 2024. This increase was primarily driven by the increase in collaboration and licensing revenue as a result of the recognition of the remaining deferred revenue associated with the termination of an exclusive channel collaboration agreement. Research and development expenses increased by $1.0 million, or 9%, compared to the three months ended September 30, 2024. The increase was primarily driven by increased manufacturing expenses and lab supplies related to commercial manufacturing of PAPZIMEOS prior to its FDA approval, professional fees incurred in connection with regulatory filing procedures as well as employee-related costs. These increases were partially offset by the capitalization of inventory-related costs subsequent to the FDA's approval of PAPZIMEOS. Selling, General and Administrative (SG&A) expenses increased by $14.2 million, or 144%, compared to the three months ended September 30, 2024. This increase was primarily due to a $9.0 million increase in costs incurred related to PAPZIMEOS commercial readiness, including sales and marketing efforts as well as professional and consulting fees. Other employee-related costs increased approximately $4.0 million, and professional and legal fees increased by $1.0 million. Total other expense, net, increased by $109.2 million compared to the three months ended September 30, 2024. This change was primarily due to a non-cash $111.5 million increase in the fair value of warrant liabilities related to the convertible preferred transaction from 2024. The Company recorded a one-time $179.0 million non-cash deemed dividend on preferred stock in the third quarter of 2025 as a reduction to additional paid-in capital (and an increase in net loss attributable to common shareholders when computing net loss per share) in accordance with Generally Accepted Accounting Principles (GAAP). On September 15, 2025, all of the outstanding Preferred Shares were converted into common shares. Net loss attributable to common shareholders was $325.3 million, or $(1.06) per basic and diluted share for the three months ended September 30, 2025, compared to a net loss of $24 million, or $(0.09) per basic and diluted share, for the three months ended September 30, 2024. The increase in net loss was significantly impacted by non-cash items including the increase in the fair value of the warrant liabilities and the deemed dividend on preferred shares (combined impact of $0.95 per share for the three months ended September 30, 2025). About RRP RRP is a rare, debilitating, and potentially life-threatening disease of the upper and lower respiratory tract caused by chronic HPV 6 or HPV 11 infection. RRP can lead to severe voice disturbance, compromised airways, and recurrent post-obstructive pneumonia. Although rare, RRP has the potential for transformation to malignant cancer and can be fatal. Management of RRP has primarily consisted of repeated surgeries, which do not address the underlying cause of the disease and can be associated with significant morbidity as well as significant patient and health system burden. As the number of lifetime surgeries increases, the risk for irreversible iatrogenic laryngeal injury increases with each surgery, and patients may undergo hundreds of these surgeries over their lifetimes. RRP can impact patients' work and social lives, financial stability, and mental health. Patients with RRP can experience substantial impacts to daily living with decreased quality of life and high health care utilization. Based on an internal analysis of claims data and electronic health records, there are approximately 27,000 adult RRP patients in the US. About PAPZIMEOS (zopapogene imadenovec-drba), for subcutaneous injection only PAPZIMEOS is the first and only FDA-approved therapy for the treatment of adults with RRP and the first and only approved therapy to address the root cause of RRP. PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen comprising selected regions of human papillomavirus (HPV) types 6 and 11 proteins. PAPZIMEOS is designed to generate an immune response directed against HPV 6 and HPV 11 proteins in patients with RRP. Discovered and designed in Precigen's labs using Precigen's proprietary AdenoVerse therapeutic platform, PAPZIMEOS represents a new therapeutic paradigm for RRP. Indication and Important Safety Information What is PAPZIMEOS? PAPZIMEOS is a type of immunotherapy used to treat a condition called recurrent respiratory papillomatosis (RRP) in adults. What is the most important information I should know about PAPZIMEOS? Some people may have a reaction to the shot. Signs and symptoms may include redness, pain, swelling, itching, or warmth where the shot was given. After your first treatment, your healthcare provider will watch you for at least 30 minutes to make sure you're feeling okay. Please contact your doctor immediately if you develop an infection, the reaction to your shot worsens, or you experience any of the below symptoms, which may indicate a systemic allergic reaction: Difficulty breathing Widespread rash Facial swelling Thrombotic events (blood clots that block your blood vessels) may occur after your PAPZIMEOS shot. Please notify your doctor immediately if you have the following symptoms: Shortness of breath Chest pain Leg swelling Persistent abdominal pain Severe or persistent headaches Blurred vision What should I know before taking PAPZIMEOS? Before taking PAPZIMEOS, tell your healthcare provider about all of your medical conditions, including: If you are pregnant or plan to become pregnant because it is not known if PAPZIMEOS will harm the unborn baby. If you are breastfeeding or plan to breastfeed. It is unknown if PAPZIMEOS is present in breast milk, or how it affects the breastfeeding child or milk production. Talk to your healthcare provider about the best way to feed your baby during treatment with PAPZIMEOS. What are the most common side effects of PAPZIMEOS? The most common side effects include: Pain, redness, or swelling where the shot was given Feeling tired Chills Fever Muscle aches Nausea (feeling sick) Headache Increased heart rate Diarrhea Vomiting Sweating a lot These are not all of the possible side effects of PAPZIMEOS. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. You may also report side effects to Precigen, Inc. at 1-855-PGE-NRRP (1-855-743-6777). Please see full Prescribing Information . Precigen: Advancing Medicine with Precision® Precigen (Nasdaq: PGEN) is a 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 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, 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, 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 [email protected] Media Contact: Donelle M. Gregory [email protected] SOURCE Precigen, Inc. 21% more press release views with Request a Demo

FDA granted priority review to Company's BLA for PRGN-2012 for the treatment of adults with recurrent respiratory papillomatosis and set PDUFA target action date for August 27, 2025 Results from pivotal clinical study of PRGN-2012 were published in The Lancet Respiratory Medicine PRGN-2012 treatment demonstrated durable complete responses with median duration of response of two years, with some complete responders surgery-free beyond three years as of August 28, 2024 data cutoff Company continues to rapidly advance commercial and manufacturing readiness campaign in anticipation of 2025 commercial launch Company ended 2024 with $97.9 million in cash, cash equivalents, and investments, extending its cash runway into 2026, beyond potential 2025 commercial launch of PRGN-2012 GERMANTOWN, Md., March 19, 2025 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced full year 2024 financial results and business updates. "Last year, we achieved several milestones on our path to potentially bring our innovative PRGN-2012 therapy to RRP patients, including presentation of groundbreaking pivotal data and BLA submission to the FDA. Through prioritizing our portfolio and financing activities, we strengthened our financial position, enabling ongoing commercial and manufacturing readiness efforts for PRGN-2012 in anticipation of a potential 2025 launch. Our commercial organization has been working to scale up quickly, right-sizing the organization to rapidly capitalize on the immense demand from patients and treating physicians for a new treatment paradigm that may finally address the underlying cause of the disease," said Helen Sabzevari, PhD, President and CEO of Precigen. "Already this year, our BLA for PRGN-2012 received priority review from the FDA with an August 2025 PDUFA action date, bringing us a step closer to launching the first and only FDA-approved treatment to the approximately 27,000 adult RRP patients in the US. FDA approval for PRGN-2012 would fundamentally change Precigen, enabling the transition from clinical to commercial stage with the real and imminent potential to begin realizing product sales this year and providing financial tailwinds to enable potential expansion of PRGN-2012 to new indications and geographical markets." "As a result of the preferred stock offering and sale of intellectual property and related royalty rights for a non-core asset, we extended our cash runway into 2026, beyond the potential commercial launch of PRGN-2012 this year. We are preparing for the transition to a commercial stage company and the potential to add product-related revenue," said Harry Thomasian Jr., CFO of Precigen. Key Program Highlights PRGN-2012 (nonproprietary name: zopapogene imadenovec†) AdenoVerse® Gene Therapy in RRP PRGN-2012 is an investigational off-the-shelf AdenoVerse gene therapy designed to elicit immune responses directed against cells infected with human papillomavirus (HPV) 6 or HPV 11 for the treatment of recurrent respiratory papillomatosis (RRP). PRGN-2012 received Breakthrough Therapy Designation, Orphan Drug Designation, and an accelerated approval pathway from the FDA, and Orphan Drug Designation from the European Commission. In February 2025, the US Food and Drug Administration (FDA) accepted the company's biologics license application (BLA) for PRGN-2012, and granted priority review to the BLA with a Prescription Drug User Fee Act (PDUFA) target action date set for August 27, 2025. The FDA has indicated that they are not currently planning to hold an advisory committee meeting to discuss the BLA. Results from the pivotal clinical study of PRGN-2012 for the treatment of RRP were presented at the 2024 American Society of Clinical Oncology (ASCO) annual meeting in a late-breaking oral presentation titled, "PRGN-2012, a novel gorilla adenovirus-based immunotherapy, provides the first treatment that leads to complete and durable responses in recurrent respiratory papillomatosis patients" and published in The Lancet Respiratory Medicine. Pivotal study successfully met its primary safety and pre-specified primary efficacy endpoints. PRGN-2012 was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2. 51% (18 out of 35) of patients achieved Complete Response, requiring no surgeries after treatment with PRGN-2012. Complete Responses have been durable beyond 12 months with median duration of follow up of 24 months, with some complete responders surgery-free beyond three years as of the August 28, 2024 data cutoff. 86% of patients (30 out of 35) had a decrease in surgical interventions in the year after PRGN-2012 treatment compared to the year prior to treatment; RRP surgeries reduced from a median of 4 (range: 3-10) pre-treatment to 0 (range: 0-7) post-treatment. PRGN-2012 treatment induced HPV 6/11-specific T cell responses in RRP patients with a significantly greater expansion of peripheral HPV-specific T cells in responders compared with non-responders. PRGN-2012 significantly (p < 0.0001) improved anatomical Derkay scores and VHI-10 scores in complete responders. Patient enrollment continues to advance in the confirmatory clinical trial of PRGN-2012 in accordance with the guidance from the FDA to initiate the study prior to submission of the BLA. The Company continues to rapidly advance its commercial and manufacturing readiness campaign in anticipation of a potential launch in 2025. Based on recently updated internal analysis derived from review of claims data, the market opportunity for PRGN-2012 in RRP is estimated to be approximately 27,000 adult patients in the US and more than 125,000 patients outside of the US. PRGN-2009 AdenoVerse® Gene Therapy in HPV-associated cancers PRGN-2009 is an investigational off-the-shelf AdenoVerse gene therapy 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 recurrent/metastatic cervical cancer and in newly diagnosed HPV-associated oropharyngeal cancer are ongoing. PRGN-3006 UltraCAR-T® in AML and MDS PRGN-3006 is an investigational multigenic, autologous chimeric antigen receptor T cell (CAR-T) therapy engineered to simultaneously express a CAR specifically targeting CD33, membrane bound IL-15 (mbIL15), and a safety/kill switch. PRGN-3006 has been granted Orphan Drug Designation in patients with acute myeloid leukemia (AML) and Fast Track Designation in patients with relapsed/refractory (r/r) AML by the FDA. The Company has completed enrollment of the Phase 1b trial for PRGN-3006 in acute myeloid leukemia (AML), which received Fast Track designation from the FDA, and is preparing for an end of Phase 1b meeting with the FDA to discuss next steps. Financial Highlights In December 2024, the Company raised $87.5 million, of which $79.0 million was from a private placement offering of convertible preferred stock, and an additional $8.5 million was from the sale of certain intellectual property and royalty rights related to a non-core asset. By year's end 2024, cash, cash equivalents, and investments totaled $97.9 million. Full Year 2024 Financial Results Compared to Prior Year Period Total revenues decreased $2.3 million, or 37%, and cost of products and services decreased $1.8 million or 30% compared to the year ended December 31, 2023. These decreases were primarily related to reductions in product and service volumes at Exemplar. Research and development expenses increased $4.5 million, or 9%, compared to the year ended December 31, 2023. This increase was primarily the result of $3.1 million of increased costs associated with the initiation of the PRGN-2012 confirmatory clinical trial, increased drug manufacturing material costs related to PRGN-2012 for potential commercial use, and professional fees incurred in conjunction with the Company's completed BLA submission and commercial readiness planning as well as the design and implementation of our manufacturing facility. Additionally, employee-related expenses rose by $3.0 million primarily due to severance charges incurred as a result of the Precigen workforce reduction in 2024 and the suspension of ActoBio's operations. These increases were partially offset by a $1.9 million reduction in depreciation and amortization expense as a result of the impairment of noncurrent assets related to the suspension of ActoBio's operations during the second quarter of 2024 as well as a reduction in clinical study expenses associated with programs that were deprioritized during the third quarter of 2024. SG&A expenses increased $0.9 million, or 2%, compared to the year ended December 31, 2023. As a result of the Company's increased focus on PRGN-2012, commercial readiness costs increased in 2024 compared to the prior year. In addition, the second and third quarters of 2024 included higher severance costs associated with the suspension of ActoBio's operations and the Precigen workforce reduction. These increases were partially offset by a decrease in stock compensation and insurance rates in 2024 compared to the same period in 2023. The Company recorded a $5.8 million impairment charge in the fourth quarter of 2024 related to its Exemplar subsidiary as a result of the Company's annual goodwill impairment test. Also, in conjunction with the suspension of ActoBio's operations, the Company recorded $34.5 million of impairment charges related to goodwill ($1.6 million) and other noncurrent assets ($32.9 million) in the second quarter of 2024. Total other income, net, increased $3.6 million, or 106% compared to the year ended December 31, 2023. This increase was primarily derived from an $8.5 million gain on the sale of intellectual property rights and royalty rights related to a non-core asset in December 2024 as well as a $0.5 million reduction in interest expense due to the final retirement of the Company Convertible Notes in the second quarter of 2023. This increase was partially offset by a reclassification of cumulative translation losses of $2.9 million, which resulted from the final closing of the ActoBio facilities in the third quarter of 2024, as well as a reduction of $1.8 million in interest income compared to the same period in 2023. Net loss was $126.2 million, or $(0.47) per basic and diluted share, compared to net loss of $95.9 million, or $(0.39) per basic and diluted share, in year ended December 31, 2023. Precigen: Advancing Medicine with Precision ® Precigen (Nasdaq: PGEN) is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. Our technologies enable us to find innovative solutions for affordable biotherapeutics in a controlled manner. Precigen operates as an innovation engine progressing a preclinical and clinical pipeline of well-differentiated therapies toward clinical proof-of-concept and commercialization. For more information about Precigen, visit or follow us on LinkedIn or YouTube. Trademarks Precigen, UltraCAR-T, UltraPorator, AdenoVerse, UltraVector 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 Some of the statements made in this press release are forward-looking statements. These forward-looking statements are based upon the Company's current expectations and projections about future events and generally relate to plans, objectives, and expectations for the development of the Company's business, including the timing and progress of preclinical studies, clinical trials, discovery programs and related milestones, the promise of the Company's portfolio of therapies, and in particular its CAR-T and AdenoVerse therapies. Although management believes that the plans and objectives reflected in or suggested by these forward-looking statements are reasonable, all forward-looking statements involve risks and uncertainties and actual future results may be materially different from the plans, objectives and expectations expressed in this press release. 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 (301) 556-9850 [email protected] Media Contacts: Donelle M. Gregory [email protected] †zopapogene imadenovec is the nonproprietary name for the investigational therapeutic known as PRGN-2012. Zopapogene imadenovec has not been approved by any health authority in any country for any indication. SOURCE Precigen, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED