Precigen Inc (PGEN)

Precigen Gains Advantage as PAPZIMEOS Granted Orphan Drug Exclusivity by FDA; Long-Term Data From Clinical Study EncouragingJune 15, 2026 6:40 AM
ACCESS NewswireMeg Flippin, Benzinga Staff WriterData reviewed by Dr. Helen Sabzevari at last week's Goldman Sachs healthcare conference suggests potential of extended surgical holidays for patients with RRP, a rare respiratory diseaseGERMANTOWN, MD / ACCESS Newswire / June 15, 2026 / Precigen Inc. (NASDAQ:PGEN) has gained an important advantage in the marketing of its new treatment for adults with recurrent respiratory papillomatosis (RRP), a rare and debilitating disease of the respiratory tract. The commercial-stage precision medicines company was just granted orphan drug exclusivity by the FDA for PAPZIMEOS™ (zopapogene imadenovec-drba), its treatment for RRP, a disease that typically requires patients to undergo multiple surgeries each year to remove benign tumors called papillomas that grow in the respiratory tract.Orphan drug exclusivity is granted to certain drugs and biologics approved for rare diseases or conditions that affect fewer than 200,000 people in the United States. The orphan drug exclusivity means the FDA can't approve any similar drugs to treat RRP for seven years, extending PAPZIMEOS' market exclusivity through August 2032."This regulatory exclusivity, together with Precigen's patent portfolio covering PAPZIMEOS and its therapeutic use, enhances the product's value by strengthening market protection and long-term revenue potential, which in turn supports continued innovation for rare diseases," said Helen Sabzevari, PhD, President and CEO of Precigen.How It WorksPAPZIMEOS uses a modified adenovirus to teach the immune system to spot and attack the proteins found in HPV 6 and HPV 11, which are the main cause of RRP. PAPZIMEOS reduces the number of surgeries a patient needs and provides a more effective way of clearing the airway, reports the company. Discovered, designed and developed in Precigen's labs using its proprietary AdenoVerse therapeutic platform, the company says PAPZIMEOS represents a new therapeutic paradigm for RRP.The drug is commercially available in the U.S. and is being prescribed nationwide across both major medical centers and community practices, with patients spanning a range of disease severities actively receiving treatment.Encouraged By Long-Term Study ResultsThe orphan drug exclusivity of PAPZIMEOS comes at a time when Precigen released encouraging long-term durability data from its pivotal study at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.The data showed that 15 out of 18 complete responders, or 83%, demonstrated ongoing complete responses for at least 36 months without any additional treatment for RRP. Five didn't need treatments after four years. Participants did not receive any additional treatments for RRP, including surgery or off-label investigational treatments, during the follow-up period, and no new safety events were observed during long-term follow-up."The presentation at ASCO marks an important maturation of the PAPZIMEOS pivotal study data, with all complete responders now followed for at least 36 months, 83% with ongoing response, including 5 patients who are surgery-free beyond 4 years," said Dr. Sabzevari. "For adults living with RRP, durability matters. These results continue to show that PAPZIMEOS provides sustained complete responses, reinforcing its role as the new standard of care for a disease historically managed through repeated surgeries." Follow-up for the study remains ongoing.PAPZIMEOS gives RRP patients another option besides surgery, and now Precigen offers a solution with some protection from competition for the next several years. With promising long-term durability results added to the mix, Dr. Sabzevari shared updates on the launch when she spoke at last week's Goldman Sachs 47th Annual Global Healthcare Conference.Contact:
Steven Harasym
investors@precigen.comClick here for more information on Precigen and PAPZIMEOSFeatured image from Shutterstock.This post contains sponsored content and was created in collaboration with a third-party partner. Benzinga is a publisher and does not provide personalized investment advice or act as a broker or dealer. This content is for informational purposes only and is not intended to be investing advice or an offer or solicitation to buy or sell any security.SOURCE: Precigen, Inc.View the original press release on ACCESS NewswireOriginal: Precigen Gains Advantage as PAPZIMEOS Granted Orphan Drug Exclusivity by FDA; Long-Term Data From Clinical Study Encouraging

Precigen and the Recurrent Respiratory Papillomatosis Foundation Recognize International RRP Awareness Day by Elevating Patient and Community VoicesJune 11, 2026 8:00 AM
PR Newswire (US) Third annual RRP Awareness Day highlights the experiences of people living with recurrent respiratory papillomatosis and marks the next era following the first FDA-approved treatment for adults with RRPGERMANTOWN, Md. and FORT WORTH, Texas, June 11, 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 and the Recurrent Respiratory Papillomatosis Foundation (RRPF), today announced continued collaboration in recognition of the third annual International RRP Awareness Day. Observed each year on June 11, RRP Awareness Day is dedicated to raising awareness and recognition of recurrent respiratory papillomatosis (RRP), a rare, chronic, and debilitating disease caused by chronic human papillomavirus (HPV) 6 or 11 infection leading to the growth of recurring benign tumors in the respiratory tract. RRP can significantly affect a person's voice, breathing, daily life, relationships and sense of normalcy. For many patients, the disease has meant years of repeated surgical procedures and the challenge of living with a condition that remains poorly understood by the broader public. RRP affects both children and adults, yet awareness of RRP remains limited. An estimated 27,000 adults in the United States and more than 170,000 adults worldwide are living with the disease. "This year, we heard clearly from the RRP community that the most important stories to share are their own," said Kim McClellan, President of the Recurrent Respiratory Papillomatosis Foundation. "RRP Awareness Day is about helping patients and families feel seen, heard, and supported. By sharing the voices of people living with RRP, we hope to increase understanding of the real burden of this disease and remind every person affected by RRP that they are not alone."This year's RRP Awareness Day centers on the voices of the RRP community, highlighting experiences from patients, caregivers, families, and healthcare providers affected by the disease. The campaign hub, rrpawareness.org, features community quotes, videos, and reflections that underscore the daily realities of RRP and the continued need for greater awareness.In August 2025, the US Food and Drug Administration approved Precigen's HPV-specific immunotherapy for adults with RRP, the first and only approved therapy for RRP. This historic milestone in RRP's more than 100-year history ushered in the next era for adult patients who have long had no approved treatment options. "RRP Awareness Day is a powerful reminder that scientific progress begins with listening to patients and understanding the burden they carry every day," said Helen Sabzevari, PhD, President and CEO of Precigen. "We are proud that Precigen's HPV-specific immunotherapy is the first approved treatment for adults with this devastating disease, marking an important milestone for the RRP community. Precigen is honored to collaborate with RRPF and the broader RRP community to help amplify patient voices and support continued progress for people living with RRP."Precigen and RRPF invite the RRP community and its supporters to visit rrpawareness.org to learn more about RRP Awareness Day and hear directly from those affected by the disease.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.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.Recurrent Respiratory Papillomatosis Foundation
The Recurrent Respiratory Papillomatosis Foundation (RRPF) was created to provide family support; promote public awareness; and aid in the prevention, cure, and treatment of recurrent respiratory papillomatosis (RRP), a rare disease that affects the voice. The most common symptoms of RRP are a hoarse or strained voice, dysphonia (difficulty in speaking), or aphonia (loss of voice). The organization focuses primarily on networking within the RRP community, including patients, families, medical practitioners, and researchers. Its goal is to stimulate more RRP-related research that may lead to more effective treatments and, ultimately, a cure for this disease. For more information about RRPF, visit www.rrpf.org.Precigen Investor Contact:
Steven M. Harasym
+1 (202) 365-2563
investors@precigen.comPrecigen Media Contact:
Donelle M. Gregory
press@precigen.comRRPF Media Contact:
Kim McClellan
info@rrpf.org View original content to download multimedia:https://www.prnewswire.com/news-releases/precigen-and-the-recurrent-respiratory-papillomatosis-foundation-recognize-international-rrp-awareness-day-by-elevating-patient-and-community-voices-302797644.htmlSOURCE Precigen, Inc. Original: Precigen and the Recurrent Respiratory Papillomatosis Foundation Recognize International RRP Awareness Day by Elevating Patient and Community Voices

Precigen Presents New Long-Term Durability Data for PAPZIMEOS, Recently Granted Seven-Year Market Exclusivity, Demonstrating Complete Responses Beyond 4 YearsMay 30, 2026 2:30 PM
PR Newswire (US) 15 out of 18 complete responders, or 83%, demonstrated ongoing complete responses for at least 36 months without any additional treatment for RRP5 complete responders have ongoing responses beyond 4 yearsFollow-up is ongoing; median duration of complete response has not yet been reachedNo new adverse safety events have been observed during long-term follow-upUS FDA granted seven-year period of orphan drug market exclusivity to PAPZIMEOSGERMANTOWN, Md., May 30, 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 updated long-term follow-up data from the pivotal study of PAPZIMEOS™ (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP). Updated durability of response data were presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago in 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."PAPZIMEOS was granted full approval by the United States Food and Drug Administration (FDA) and was subsequently granted seven-year market exclusivity, further strengthening its position as the first and only approved therapy for the treatment of adults with RRP.Key data highlights from the ASCO presentation include:15 out of 18 complete responders, or 83%, demonstrated ongoing complete responses as of the April 30, 2026 data cutoff (see Figure 1);Patients did not receive any additional treatments for RRP, including surgery or off-label investigational treatments, during this follow-up period;All complete responders had at least 36 months of follow-up, with a median follow-up of 36 months (range: 36 to 51 months) and a mean follow-up of 40 months;5 complete responders have ongoing responses beyond 4 years;Median duration of complete response has not yet been reached; andNo new safety events were observed during long-term follow-up."The presentation at ASCO marks an important maturation of the PAPZIMEOS pivotal study data, with all complete responders now followed for at least 36 months, 83% with ongoing response, including 5 patients who are surgery-free beyond 4 years," said Helen Sabzevari, PhD, President and CEO of Precigen. "For adults living with RRP, durability matters. These results continue to show that PAPZIMEOS provides sustained complete responses, reinforcing its role as the new standard of care for a disease historically managed through repeated surgeries."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 InformationWhat 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 breathingWidespread rashFacial swellingThrombotic 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 breathChest painLeg swellingPersistent abdominal painSevere or persistent headachesBlurred visionWhat 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 givenFeeling tiredChillsFeverMuscle achesNausea (feeling sick)HeadacheIncreased heart rateDiarrheaVomitingSweating a lotThese 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 www.fda.gov/medwatch 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 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 View original content to download multimedia:https://www.prnewswire.com/news-releases/precigen-presents-new-long-term-durability-data-for-papzimeos-recently-granted-seven-year-market-exclusivity-demonstrating-complete-responses-beyond-4-years-302786302.htmlSOURCE Precigen, Inc. Original: Precigen Presents New Long-Term Durability Data for PAPZIMEOS, Recently Granted Seven-Year Market Exclusivity, Demonstrating Complete Responses Beyond 4 Years

Precigen to Participate in Fireside Chats with J.P. Morgan and at the Goldman Sachs 47th Annual Global Healthcare ConferenceMay 26, 2026 8:05 AM
PR Newswire (US) GERMANTOWN, Md., May 26, 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 the company will participate in two upcoming investor events. The J.P. Morgan virtual fireside chat will be held on Monday, June 1, at 10:00 a.m. ET. The event will be hosted by Brian Cheng, Senior Biotech Analyst, J.P. Morgan. Precigen participants will include Helen Sabzevari, PhD, President and CEO, and Phil Tennant, Chief Commercial Officer.The Goldman Sachs 47th Annual Global Healthcare Conference will be held from June 8 to 10, 2026, in Miami Beach, Florida. Helen Sabzevari, PhD, President and CEO, Precigen, will participate in a fireside chat on Monday, June 8, at 9:20 a.m. ET.Participants may view details for these events on Precigen's website in the Events & Presentations section at investors.precigen.com/events-presentations.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.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.comMedia Contact:
Donelle M. Gregory
press@precigen.com View original content to download multimedia:https://www.prnewswire.com/news-releases/precigen-to-participate-in-fireside-chats-with-jp-morgan-and-at-the-goldman-sachs-47th-annual-global-healthcare-conference-302781349.htmlSOURCE Precigen, Inc. Original: Precigen to Participate in Fireside Chats with J.P. Morgan and at the Goldman Sachs 47th Annual Global Healthcare Conference

Precigen Reports First Quarter 2026 Financial Results and Business UpdatesMay 13, 2026 4:05 PM
PR Newswire (US) PAPZIMEOS™ launch gaining strong momentum with $21.6 million in net product revenue in the first quarter of 2026 reflecting broad-based uptake across the USPatient 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 administrationUpdated durability of response data for PAPZIMEOS will be presented at the upcoming ASCO Annual MeetingRRP 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) communityThe Company continues to advance PRGN-2009 in HPV-associated cancers and plans to provide an AdenoVerse® pipeline update by end of yearCash, cash equivalents, and investments totaled $56.7 million as of March 31, 2026, which together with the anticipated proceeds from PAPZIMEOS revenue, is expected to fund the Company's operations to cash flow break-even by the end of 2026Conference call scheduled for 4:30 PM ET todayGERMANTOWN, 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 HIGHLIGHTSPAPZIMEOS™: 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 $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 Period
Total 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.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 SubsidiariesConsolidated Balance Sheets(Unaudited)
(Amounts in thousands)March 31, 2026
December 31, 2025Assets


Current assets


    Cash and cash equivalents$              7,480
$             30,234    Short-term investments48,766
67,624    Receivables


        Trade, net26,403
3,916        Other302
446    Inventory14,725
9,581    Prepaid expenses and other3,996
3,434                Total current assets101,672
115,235Long-term investments489
2,511Property, plant and equipment, net13,219
13,758Intangible assets, net2,864
3,182Goodwill15,232
15,232Right-of-use assets4,369
4,679Other assets782
908                Total assets$           138,627
$           155,505Liabilities and Shareholders' Equity


Current liabilities


    Accounts payable$              2,589
$             11,985    Accrued compensation and benefits4,556
10,199    Other accrued liabilities12,481
10,993    Indemnification accruals—
2,476    Deferred revenue410
517    Current portion of lease liabilities1,068
1,136                Total current liabilities21,104
37,306Long-term debt93,519
93,174Lease liabilities, net of current portion3,663
3,980Other long-term liabilities106
134                Total liabilities118,392
134,594Shareholders' equity


    Additional paid-in capital2,369,529
2,362,252    Accumulated deficit(2,349,277)
(2,341,348)    Accumulated other comprehensive (loss) income         (17)
7                Total shareholders' equity20,235
20,911                Total liabilities and shareholders' equity$           138,627
$           155,505 Precigen, Inc. and SubsidiariesConsolidated Statement of Operations(Unaudited)
(Amounts in thousands, except share Three Months Ended  March 31, and per share data)2026
2025Revenues


Product revenues, net$             21,828
$                203Service revenues1,424
1,138Total revenues23,252
1,341Operating Expenses


Cost of products and services2,559
1,100Research and development5,638
10,478Selling, general and administrative21,049
12,359Total operating expenses29,246
23,937Operating loss(5,994)
(22,596)Other Income (Expense), Net


Change in fair value of warrant liabilities—
(32,481)Interest expense(2,908)
(1)Interest income683
918Other income, net290
7Total 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  View original content to download multimedia:https://www.prnewswire.com/news-releases/precigen-reports-first-quarter-2026-financial-results-and-business-updates-302771455.htmlSOURCE Precigen, Inc. Original: Precigen Reports First Quarter 2026 Financial Results and Business Updates

Precigen Reports 'Robust Uptake' of New Drug for Rare Respiratory Disease; First Quarter Revenue Expected to Top $18 MillionApril 7, 2026 7:00 AM
ACCESS NewswirePlans Underway to Expand Use to Pediatrics, Patient Redosing and European ApprovalMeg Flippin, Benzinga Staff WriterGERMANTOWN, MD / ACCESS Newswire / April 7, 2026 / Precigen Inc. (NASDAQ:PGEN), a commercial-stage biopharmaceutical company developing precision medicines to improve the quality of life for people suffering from recurrent respiratory papillomatosis (RRP) and other diseases, is making progress on that front, announcing it has seen "robust uptake" in usage of PAPZIMEOS (zopapogene imadenovec-drba), since launching the immunotherapy in August 2025. What's more, the company announced that the Centers for Medicare & Medicaid Services (CMS) assigned J-code J3404 to the therapy effective April 1, 2026, which will streamline reimbursement and broaden access to the treatment. "In the short time since early and full approval, the standard-of-care first-line treatment is seeing tremendous progress," said Precigen's President and CEO, Helen Sabzevari, during a conference call to discuss fourth quarter results. "This substantial advancement constitutes a pivotal milestone for all stakeholders impacted by RRP." As a result of the interest in PAPZIMEOS, Sabzevari said the company is transforming from a research and development biopharmaceutical company to a product revenue generating biotech company. Net product sales of PAPZIMEOS were $3.4 million in the fourth quarter of 2025, with shipments commencing in November. In the fourth quarter, Precigen patient hub enrollment surpassed 300, a testament to physician and patient demand.Sabzevari noted the company expects revenue in the first quarter of 2026 to exceed $18 million given the momentum of PAPZIMEOS. "This is a clear sign of the enthusiasm we are seeing from patients and physicians alike, leading to a robust use of the immunotherapy," she said.An Alternative To SurgeryPAPZIMEOS is an FDA-approved HPV-specific immunotherapy for the treatment of adults with RRP and, as reported by the company, the first-and-only approved therapy to address the root cause of RRP. RRP is a rare and debilitating disease that often requires patients to undergo multiple surgeries each year to remove benign tumors called papillomas that grow in the respiratory tract.Instead of surgically removing the papillomas, PAPZIMEOS uses a modified adenovirus to teach the immune system to spot and attack the proteins found in HPV 6 and HPV 11, which are the main cause of RRP. PAPZIMEOS reduces the number of surgeries a patient needs and provides a more effective way of maintaining a clear airway, reports the company. Discovered and designed in Precigen's labs using Precigen's proprietary AdenoVerse therapeutic platform, the company says PAPZIMEOS represents a new therapeutic paradigm for RRP.It is something the FDA seems to have agreed with, given that in August, the FDA granted full approval for PAPZIMEOS with a broad label and no requirement for a confirmatory trial for the treatment of adults with RRP. Since then, the treatment has been prescribed nationwide, with patients actively receiving treatment across the U.S.Leading RRP Physicians Agree With FDARecently, a new expert consensus paper - sponsored by the Recurrent Respiratory Papillomatosis Foundation (RRPF) and authored by 16 leading physicians in the field of RRP - in support of the treatment was published in The Laryngoscope, one of the field's most respected peer-reviewed journals, reports Precigen. The paper recommends PAPZIMEOS as the new standard-of-care first-line treatment for adults with RRP. Precigen said the paper represents a landmark moment for the RRP community, formalizing a shift away from surgery toward a new standard of care that treats the underlying HPV infection.As it stands, there are about27,000 active adult cases of RRP in the U.S. and in excess of 150,000 total worldwide, according to Precigen. RRP affects both children and adults. Symptoms include a progressive hoarseness of the voice, difficulty swallowing, chronic coughing and breathing problems. In extreme cases, the disease can be fatal if the papillomas cause severe airway obstruction to the lungs and the lungs become flooded with fluids and infection. In rare cases, RRP can malignantly transform into cancer.Outside of PAPZIMEOS, the historical standard-of-care treatment for RRP was repeat surgeries to reduce the papillomas. As a result, lots of RRP patients required hundreds of surgeries over their lifetimes, which impacts their quality of life and, for many people, creates an economic burden. After all, the surgeries are only effective at removing bulked up papillomas in the respiratory tract, but not at preventing future buildup. What's more, these frequent surgeries for RRP can worsen a patient's condition over time by potentially increasing the spread of the HPV virus and the likelihood of serious co-morbidities, including breathing issues and loss of vocal function.Beyond U.S. Adults: Pediatrics and EuropeWith many in the U.S. embracing PAPZIMEOS as a new standard of care for RRP in adults, Precigen is now setting its sights on treating pediatric RRP patients and bringing the drug to adults in Europe.During a conference call, Sabzevari said Precigen expects to launch a pediatric RRP trial in the fourth quarter of 2026.The company also announced a study to evaluate the potential for redosing patients, which could increase the overall impact to patients.In November 2025, the company filed with the European Medicines Agency (EMA) for European approval for RRP in adults. Precigen said the EMA validated the PAPZIMEOS Marketing Authorization Application and the application is under review.RRP is a rare and debilitating disease that severely impacts the quality of life for sufferers. Precigen is helping change that. With the treatment taking off in the U.S, and with expansion underway in Europe and into pediatric RRP, Precigen is giving hope to the tens of thousands of patients who have no other choice than to have recurring surgeries. To learn more about Precigen and PAPZIMEOS, click here.Click here for more information on Precigen, Inc.Featured image from Shutterstock.This post contains sponsored content and was created in collaboration with a third-party partner. Benzinga is a publisher and does not provide personalized investment advice or act as a broker or dealer. This content is for informational purposes only and is not intended to be investing advice or an offer or solicitation to buy or sell any security.Contact:
Investor Relations
investors@precigen.comSOURCE: Precigen, IncView the original press release on ACCESS NewswireOriginal: Precigen Reports 'Robust Uptake' of New Drug for Rare Respiratory Disease; First Quarter Revenue Expected to Top $18 Million

Precigen to Participate in a Fireside Chat with H.C. Wainwright on March 31March 30, 2026 8:30 AM
PR Newswire (US)

GERMANTOWN, Md., March 30, 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 Helen Sabzevari, PhD, President and CEO, and Phil Tennant, Chief Commercial Officer, of Precigen, will participate in a virtual fireside chat with H.C. Wainwright on March 31, 2026 from 11:00 AM – 12:00 PM ET.







Participants may view details for this event on Precigen's website in the Events & Presentations section at investors.precigen.com/events-presentations.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.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.comMedia Contact:
Donelle M. Gregory
press@precigen.com



View original content to download multimedia:https://www.prnewswire.com/news-releases/precigen-to-participate-in-a-fireside-chat-with-hc-wainwright-on-march-31-302728209.htmlSOURCE Precigen, Inc.

Original: Precigen to Participate in a Fireside Chat with H.C. Wainwright on March 31

Precigen Reports Full Year 2025 Financial Results and Business UpdatesMarch 25, 2026 4:05 PM
PR Newswire (US)

Precigen transitioned to a commercial stage company with the US approval of PAPZIMEOS™ (zopapogene imadenovec-drba), the first-and-only FDA-approved treatment for adults with RRP, in August 2025PAPZIMEOS generated $3.4 million in net product revenue in the fourth quarter of 2025, reflecting the first partial quarter of US commercial sales as payer policies came into effect; the US launch continues to build strong momentum, with a significant increase in demand in the first quarter of 2026 The Centers for Medicare and Medicaid Services has assigned a permanent J-code, J3404, to PAPZIMEOS, effective April 1, 2026, streamlining the claims process and facilitating broader patient accessMarketing Authorization Application for PAPZIMEOS for the treatment of adults with RRP validated by the European Medicines Agency and is under reviewOpen-label redosing study initiated to evaluate retreatment efficacy of zopapogene imadenovec in adults with RRP Expert consensus 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 USCash, cash equivalents, and investments totaled $100.4 million as of December 31, 2025, which is expected to fund the Company's operations to cash flow break-evenConference call scheduled for 4:30 PM ET today to discuss full year 2025 financial results and provide further substantive updates on commercial progress for the first quarter of 2026GERMANTOWN, Md., March 25, 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 full year 2025 financial results and business updates.







"With the FDA approval and launch of PAPZIMEOS, 2025 marked a transformational year for Precigen as we transitioned from a clinical-stage to a commercial-stage company and recognized our first commercial product revenues toward the end of the year," said Helen Sabzevari, PhD, President and CEO of Precigen. "We are seeing strong alignment within the physician community around PAPZIMEOS as the first-line standard of care for adults with RRP, supported by its profile as the only approved therapy for RRP, the compelling safety and efficacy data, and the encouraging durability of response observed to date. This is an exciting time for Precigen, and we look forward to sharing further updates during our call regarding the significant momentum we're seeing in the first quarter.""Commercialization of PAPZIMEOS continues to move rapidly, with growing physician adoption and patient uptake since approval in August. Since deploying our full field organization, we have engaged all target medical institutions and are seeing prescriptions and active treatment across the United States in both major medical centers and community practices. Patient hub enrollment has surpassed 300 patients, reflecting strong demand, while payer coverage now extends to approximately 215 million lives across private insurers, as well as Medicare and Medicaid. The recently published Recurrent Respiratory Papillomatosis Foundation-sponsored expert consensus paper recommending PAPZIMEOS as the first-line standard of care for adults with RRP further reinforces the momentum we are seeing as we continue to see expanded patient access." said Phil Tennant, Chief Commercial Officer of Precigen.KEY PROGRAM HIGHLIGHTSPAPZIMEOS: Establishing a New Standard of Care for the Treatment of Adults with RRP PAPZIMEOS full approval with broad label: In August 2025, the FDA granted full approval of PAPZIMEOS with a broad label for the treatment of adults with RRP.PAPZIMEOS prescribing, treatment, and distribution: Since full deployment of the PAPZIMEOS field team in September 2025, 100% of target medical institutions have been engaged. PAPZIMEOS is now being prescribed nationwide across both major medical centers and community practices, with patients spanning a range of disease severities actively receiving treatment.Strong patient and physician demand: To date, PAPZIMEOS patient hub enrollment has surpassed 300 registered patients, reflecting substantial patient and physician demand. In addition to these registered patients, a significant number of patients have been identified outside of the PAPZIMEOS hub through the Company's field engagement efforts.Positive payer coverage: Patient access continues to expand, with private health plan coverage now estimated at approximately 215 million US lives, including the significant majority of leading insurers. PAPZIMEOS is also covered under Medicare and Medicaid. Collectively, coverage now extends to approximately 90% of insured lives in the US.J-code assigned: The Centers for Medicare and Medicaid Services has assigned a permanent J-code, J3404, to PAPZIMEOS, effective April 1, 2026. J-codes are standardized reimbursement codes that allow healthcare providers to bill government and commercial insurers for physician-administered therapies. Assignment of a permanent J-code streamlines claims processing and will likely facilitate broader patient access.PAPZIMEOS recommended as new standard of care first-line treatment: In January 2026, an expert consensus 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.Compelling long-term clinical and real-world evidence published: At AAO-HNSF 2025, SITC 2025, and EUROGIN 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 initiated: The Company initiated an open-label study to evaluate safety, vector shedding, and retreatment efficacy of zopapogene imadenovec in adults with RRP (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.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.PRGN-2009 Phase 2 clinical trial in combination with pembrolizumab in recurrent/metastatic cervical cancer is ongoing.FINANCIAL RESULTS"2025 was a game-changing year for Precigen with the FDA approval of PAPZIMEOS. We began preparing for the commercial launch of PAPZIMEOS well before the FDA's approval and significantly increased our investment in commercialization efforts as 2025 progressed to support the successful launch of PAPZIMEOS," said Harry Thomasian Jr., Chief Financial Officer of Precigen. "Our first sale of PAPZIMEOS was recorded in the fourth quarter of 2025 and we are encouraged by continued revenue momentum we're seeing as we begin the new year. Based upon our present forecast, we expect 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, representing a strong financial foundation as we continue to execute on our commercial and strategic objectives."Full Year 2025 Financial Results Compared to Prior Year Period
Total revenues increased by $5.8 million compared to the year ended December 31, 2024. This increase was primarily driven by the commencement of PAPZIMEOS product revenue, which totaled $3.4 million in 2025, reflecting the first partial quarter of US commercial sales following the Company's commercial launch, as well as higher collaboration and licensing revenue of $1.8 million 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 decreased by $11.7 million, or 22.1%, compared to the year ended December 31, 2024. The decrease was primarily driven by a $5.4 million reduction in costs associated with ActoBio after the Company closed its operations in 2024. External services also declined by approximately $4.0 million, due to reduced activity for contract research organizations as a result of the strategic prioritization of the Company's pipeline announced in the third quarter of 2024. In addition, the Company, upon FDA approval of PAPZIMEOS, began classifying manufacturing-related costs to inventory, which ultimately will be recorded as cost of products and services when the related inventory is sold. Manufacturing costs related to PAPZIMEOS were recorded as research and development expenses prior to the FDA approval of PAPZIMEOS.Selling, General and Administrative (SG&A) expenses increased by $28.8 million, or 69.8%, compared to the year ended December 31, 2024. This increase was primarily due to a $27.3 million increase in costs incurred related to PAPZIMEOS commercial readiness, including sales force expansion, marketing and advertising, as well as professional and other fees associated with the commercial launch of PAPZIMEOS.In connection with the suspension of ActoBio's operations in 2024, the Company recorded $34.5 million of impairment charges related to goodwill and long-lived assets in the second quarter of 2024. Additionally, in the second quarter of 2025, the Company recorded $3.9 million of impairment charges related to the Exemplar reporting unit, compared to $5.8 million of impairment charges related to the Exemplar reporting unit in the prior year period.Total other income (expense), net, decreased from income, net of $7.0 million in 2024 to expense, net of $140.1 million in 2025. This decrease was primarily driven by a $139.5 million increase in the fair value of warrant liabilities prior to their reclassification into permanent equity in the third quarter of 2025. Substantially all of the increase in the fair value of warrant liabilities was as a result of an increase in the Company's common stock price at the valuation date compared to December 31, 2024.The Company recorded a $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 US 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 $429.6 million, or $1.37 per basic and diluted share for the year ended December 31, 2025, compared to a net loss of $126.2 million, or $0.47 per basic and diluted share, for the year ended December 31, 2024. The increase in net loss was primarily driven by non-cash items, including the increase in the fair value of the warrant liabilities and the deemed dividend on preferred shares noted above (combined impact of $318.5 million or $1.02 per share).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.comMedia Contact:
Donelle M. Gregory
press@precigen.com Precigen, Inc. and SubsidiariesConsolidated Balance Sheets(Unaudited) (Amounts in thousands)December 31, 2025
December 31, 2024Assets


Current assets


    Cash and cash equivalents$             30,234
$             29,517    Short-term investments67,624
68,393    Receivables


        Trade, net3,916
926        Other446
237    Inventory9,581
—    Prepaid expenses and other3,434
3,341                Total current assets115,235
102,414Long-term investments2,511
—Property, plant and equipment, net13,758
13,831Intangible assets, net3,182
4,455Goodwill15,232
19,139Right-of-use assets4,679
5,056Other assets908
371                Total assets$           155,505
$           145,266Liabilities, Mezzanine Equity and Shareholders' Equity


Current liabilities


    Accounts payable$             11,985
$              3,531    Accrued compensation and benefits10,199
8,417    Other accrued liabilities10,993
4,812    Indemnification accrual2,476
3,213    Deferred revenue517
589    Current portion of lease liabilities1,136
956                Total current liabilities37,306
21,518Long-term debt93,174
—Deferred revenue, net of current portion—
1,934Lease liabilities, net of current portion3,980
4,546Other long-term liabilities134
—Warrant liabilities-
50,537                Total liabilities134,594
78,535Mezzanine equity-
28,218Shareholders' equity


    Common stock-
-    Additional paid-in capital2,362,252
2,129,207    Accumulated deficit(2,341,348)
(2,090,706)    Accumulated other comprehensive income 7
12                Total shareholders' equity20,911
38,513                Total liabilities, mezzanine equity and shareholders' equity$           155,505
$           145,266 Precigen, Inc. and SubsidiariesConsolidated Statement of Operations(Unaudited) (Amounts in thousands, except share Year Ended and per share data)December 31, 2025
December 31, 2024Revenues


Collaboration and licensing revenue$              1,818
$                   -Product revenues, net3,975
422Service revenues3,891
3,503Total revenues9,684
3,925Operating Expenses


Cost of products and services4,823
4,267Research and development41,333
53,070Selling, general and administrative70,128
41,293Impairment of goodwill3,907
7,409Impairment of other noncurrent assets-
32,915Total operating expenses120,191
138,954Operating loss(110,507)
(135,029)Other Income (Expense), Net


Change in fair value of warrant liabilities(139,523)
-Interest expense(3,867)
(6)Interest income3,215
1,418Other income, net43
5,589Total other (expense) income, net(140,132)
7,001Loss before income taxes(250,639)
(128,028)Income tax (expense) benefit(3)
1,793Net loss$          (250,642)
$          (126,235)Deemed dividends on preferred stock(179,000)
-Net loss attributable to common shareholders$          (429,642)
$          (126,235)Net Loss per share attributable to common shareholders


Net loss per share attributable to common shareholders, basic and diluted$              (1.37)
$              (0.47)Weighted average shares outstanding, basic and diluted312,980,562
267,727,426 



View original content to download multimedia:https://www.prnewswire.com/news-releases/precigen-reports-full-year-2025-financial-results-and-business-updates-302725242.htmlSOURCE Precigen, Inc.

Original: Precigen Reports Full Year 2025 Financial Results and Business Updates

Precigen to Announce Full Year 2025 Financial Results and Provide Business Updates on March 25March 11, 2026 4:05 PM
PR Newswire (US)

GERMANTOWN, Md., March 11, 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 the Company will release full year 2025 financial results and provide business updates on Wednesday, March 25, 2026. The Company will host a conference call to discuss results that day at 4:30 PM ET.







The conference call may be accessed by dialing 1-800-836-8184 (North America) or 1-646-357-8785 (International). Participants are asked to dial in 10-15 minutes in advance of the scheduled call time to facilitate timely connection to the call.Event details can be found on Precigen's website in the Events & Presentations section at investors.precigen.com/events-presentations.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.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
investors@precigen.comMedia Contact:
Donelle M. Gregory
press@precigen.com



View original content to download multimedia:https://www.prnewswire.com/news-releases/precigen-to-announce-full-year-2025-financial-results-and-provide-business-updates-on-march-25-302710140.htmlSOURCE Precigen, Inc.

Original: Precigen to Announce Full Year 2025 Financial Results and Provide Business Updates on March 25

PGEN BIO MONSTER - MOONINGLY READY TO FLY

Friday magnet

Hmmm... Looks like that $5 magnet is holding us back, kinda like gravity.

Mama…r we ready for the moon….yes child, fasten your seatbelt

Mama…where we going…we going to the moon child!

That 15 min Bollinger band climb is a thing of beauty

The bio beast is breaking her chains

Here we go

Oh no someone making money lol.. 5.06 + 30% 

You are daddy

Mama….whos your daddy?

Monthly is thin…get ready to freaking rumble

Blue sky break out after 5.32

PGEN magnet taken out

PGEN monster. Woke the fuc up thank goodness

Only FDA drug on the market.

PGEN here we go

PGEN here we go to magnet

PGEN 5.00 magnet

That was dumb…back in

Out for a good days work

PGEN in play today

I agree.   Nice terms and no dilution 

Thanks. EOM

"I am pleased to announce this non-dilutive financing with Pharmakon, a respected leader in strategic life sciences funding," said Helen Sabzevari, PhD, President and CEO of Precigen. "This fortifies our position for robust US commercialization of PAPZIMEOS, our groundbreaking novel immunotherapy, while also supporting efforts to expand to international markets and pursue pediatric and additional HPV-related indications. Precigen has demonstrated the strength of our innovative therapeutic platforms and is now advancing into the next stage as a commercial company. With the potential for revenue from PAPZIMEOS on the horizon, we are well-positioned to deliver meaningful growth and establish Precigen as a leading biopharma innovator."

Harry Thomasian, Jr., Chief Financial Officer of Precigen adds, "Strengthening our balance sheet provides us with the financial flexibility to commercialize PAPZIMEOS while advancing our broader strategic objectives as Precigen enters a period of projected significant growth."

Precigen Signs Up to $125 Million Credit Facility

with Pharmakon Advisors

08:02 AM EDT, 09/03/2025 (MT Newswires) -- Precigen (PGEN) said Wednesday that it has signed a two-tranche credit facility deal of up to $125 million with investment funds managed by Pharmakon Advisors.

The first tranche of $100 million was financed at closing, while the second tranche of $25 million can be drawn by Precigen through March 31, 2027, the biopharmaceutical company said.

The $100 million tranche will support US commercialization of Papzimeos immunotherapy to treat recurrent respiratory papillomatosis in adults, the company said.

Precigen said the credit facility would mature on the fifth anniversary of the first tranche's closing date.

Shares of Precigen were up more than 3% in recent Wednesday premarket activity.

Awesome NEWS of non-dilutive funding.

Doesn't get any better than that.

Precigen Signs Up to $125 Million Credit Facility Deal With Pharmakon Advisors
08:02:09 AM ET, 09/03/2025 - MT Newswires
08:02 AM EDT, 09/03/2025 (MT Newswires) -- Precigen (PGEN) said Wednesday that it has signed a two-tranche credit facility deal of up to $125 million with investment funds managed by Pharmakon Advisors.

The first tranche of $100 million was financed at closing, while the second tranche of $25 million can be drawn by Precigen through March 31, 2027, the biopharmaceutical company said.

The $100 million tranche will support US commercialization of Papzimeos immunotherapy to treat recurrent respiratory papillomatosis in adults, the company said.

Precigen said the credit facility would mature on the fifth anniversary of the first tranche's closing date.

Shares of Precigen were up more than 3% in recent Wednesday premarket activity.

where did they say that?   thank you!

Precigen (PGEN) said Wednesday that it has signed a two-tranche credit facility deal of up to $125 million with investment funds managed by Pharmakon Advisors.The first tranche of $100 million was funded at closing. A second tranche of $25 million can be drawn at Precigen's discretion through March 31, 2027, subject to certain conditions. Briefing says non-dilutive financing.

Today's volume was heavier than usual

trading 9,867,764 shares, versus an average of 2,906,211 shares per day during the last twelve months. The On Balance Volume indicator (OBV) is bullish. The slope of the indicator is positive and suggests that buyers are presently more active than sellers.

Momentum for PGEN is strongly bullish.

The 14-period Slow Stochastic oscillator is above 80, the level which many analysts call overbought. This means that investors have been actively purchasing shares and driving the price higher.

PGEN is in a strong bullish trend.

Its 200-day moving average is upwards sloping and the MACD histogram is above 0. Comparative Relative Strength analysis shows that this issue is outperforming the S&P 500.

Good day today. Slow but consistent

move north. I like the fact that 65% of OS is owned by institutions.

Not happy with the volume.   I'm out.    Best of luck to you all.  

https://www.stocktitan.net/news/PGEN/precigen-to-participate-in-upcoming-virtual-fireside-chats-hosted-by-zlq86owu0n9n.html?utm_source=chatgpt.com

No additional PDUFA news     There will be 2 presentations soon.   Heavy volume again this AM.  

Thanks. Let us all know. EOM

The PUFDA data was rhe 27th of aug.   ChatGPT says manufactoung and other info will still be given on the 27th.  Google AI says everything was completed on the 27th.   The Co. never responded to me. Guess I'll find out on Monday. 

That date is 2027, not 2025. EOM

i'm getting conflicting answers on if this meeting is needed to discuss manufacturing, etc.   Contacted IR waiting for a reply. 

PGEN .....OUT...EXTENDED