预约演示
更新于：2026-08-22
PRGN-2009
更新于：2026-08-22
概要
基本信息
原研机构 |
在研机构 |
非在研机构- |
权益机构- |
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
登录后查看时间轴
关联
4
项与 PRGN-2009 相关的临床试验NCT06157151
A Multicenter Phase 2 Study to Evaluate Efficacy and Safety of PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer.
This Phase 2 study will evaluate the efficacy and safety of PRGN-2009 in combination with pembrolizumab in patients with pembrolizumab-resistant recurrent or metastatic cervical cancer.
开始日期2025-11-11 |
申办/合作机构  Precigen, Inc. [+1] |
NCT06223568
Phase II Trial of Neoadjuvant Chemotherapy (NAC) Alone or in Combination With Immunotherapy Vaccine PRGN-2009 in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal (Head and Neck) Cancer
Background:
Throat cancer is a common tumor that can occur in people infected with the human papilloma virus (HPV). Most people with this cancer survive more than 5 years with standard chemotherapy drugs plus radiation. But radiation can cause serious adverse effects. Researchers believe that adding a vaccine (PRGN-2009) to this drug therapy may improve survival without the need for radiation.
Objective:
To test a study vaccine combined with standard chemotherapy in patients with HPV-associated throat cancers.
Eligibility:
People aged 18 years and older with newly diagnosed throat cancer associated with HPV.
Design:
Participants will be screened. They will have a physical exam and blood tests. They will have imaging scans and tests of their heart function and hearing. They will provide a sample of tissue from their tumor. A recent sample may be used; if none is available, a new sample will be taken.
All participants will get two common drugs for treating cancer. These drugs are given through a tube attached to a needle inserted into a vein in the arm. Participants will receive these drugs on the first day of three 3-week cycles.
Half of the participants will also get the vaccine. PRGN-2009 is injected under the skin in the arm. They will get these shots 4 times: 7 days before the start of the first cycle and on the 11th day of each cycle.
Participants will have standard surgery to remove their tumors 3 to 6 weeks after completing the study treatment. They will have follow-up visits 3, 6, 12, and 24 months after their surgery.
...
Throat cancer is a common tumor that can occur in people infected with the human papilloma virus (HPV). Most people with this cancer survive more than 5 years with standard chemotherapy drugs plus radiation. But radiation can cause serious adverse effects. Researchers believe that adding a vaccine (PRGN-2009) to this drug therapy may improve survival without the need for radiation.
Objective:
To test a study vaccine combined with standard chemotherapy in patients with HPV-associated throat cancers.
Eligibility:
People aged 18 years and older with newly diagnosed throat cancer associated with HPV.
Design:
Participants will be screened. They will have a physical exam and blood tests. They will have imaging scans and tests of their heart function and hearing. They will provide a sample of tissue from their tumor. A recent sample may be used; if none is available, a new sample will be taken.
All participants will get two common drugs for treating cancer. These drugs are given through a tube attached to a needle inserted into a vein in the arm. Participants will receive these drugs on the first day of three 3-week cycles.
Half of the participants will also get the vaccine. PRGN-2009 is injected under the skin in the arm. They will get these shots 4 times: 7 days before the start of the first cycle and on the 11th day of each cycle.
Participants will have standard surgery to remove their tumors 3 to 6 weeks after completing the study treatment. They will have follow-up visits 3, 6, 12, and 24 months after their surgery.
...
开始日期2024-06-10 |
申办/合作机构 |
NCT05996523
Phase II Trial of Immunotherapeutic HPV Vaccine PRGN-2009 With Pembrolizumab Before Standard Treatment in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal Cancer
Background:
Cancers in and around the mouth associated with human papilloma virus (HPV) are common. Two treatments (the drug pembrolizumab and the HPV vaccine PRGN-2009) have been shown to work well when used individually against these cancers. Researchers want to find out if they might work better when used together.
Objective:
To test pembrolizumab combined with PRGN-2009 in people with HPV-positive cancers in and around the mouth.
Eligibility:
Adults aged 18 and older newly diagnosed with HPV-positive cancers in and around the mouth.
Design:
Participants will be screened. They will have a physical exam with blood tests. They will have imaging scans. They may need to have a biopsy: A sample of tissue will be taken from the tumor.
PRGN-2009 is given as an injection under the skin. Pembrolizumab is given through a tube attached to a needle inserted into a vein in the arm.
Participants will have at least 3 clinic visits: At the first, they will receive both the drug and the vaccine; 15 days later, they will receive a second shot of the vaccine. At the third visit, about 1 week after the second, they will have follow-up tests.
During these visits, participants will give samples of blood, urine, and saliva. Imaging scans and biopsies will be repeated. They will have tests of their heart function.
Participants may opt to return for another follow-up visit about 1 month after their second dose of the vaccine.
Participants will have follow-up contacts by phone 3 and 6 months after starting the study. The calls will continue once a year for 5 years.
Cancers in and around the mouth associated with human papilloma virus (HPV) are common. Two treatments (the drug pembrolizumab and the HPV vaccine PRGN-2009) have been shown to work well when used individually against these cancers. Researchers want to find out if they might work better when used together.
Objective:
To test pembrolizumab combined with PRGN-2009 in people with HPV-positive cancers in and around the mouth.
Eligibility:
Adults aged 18 and older newly diagnosed with HPV-positive cancers in and around the mouth.
Design:
Participants will be screened. They will have a physical exam with blood tests. They will have imaging scans. They may need to have a biopsy: A sample of tissue will be taken from the tumor.
PRGN-2009 is given as an injection under the skin. Pembrolizumab is given through a tube attached to a needle inserted into a vein in the arm.
Participants will have at least 3 clinic visits: At the first, they will receive both the drug and the vaccine; 15 days later, they will receive a second shot of the vaccine. At the third visit, about 1 week after the second, they will have follow-up tests.
During these visits, participants will give samples of blood, urine, and saliva. Imaging scans and biopsies will be repeated. They will have tests of their heart function.
Participants may opt to return for another follow-up visit about 1 month after their second dose of the vaccine.
Participants will have follow-up contacts by phone 3 and 6 months after starting the study. The calls will continue once a year for 5 years.
开始日期2023-11-07 |
申办/合作机构 |
100 项与 PRGN-2009 相关的临床结果
登录后查看更多信息
100 项与 PRGN-2009 相关的转化医学
登录后查看更多信息
100 项与 PRGN-2009 相关的专利（医药）
登录后查看更多信息
1
项与 PRGN-2009 相关的文献（医药）2021-04-08·JCI insight1区 · 医学
Characterization of recombinant gorilla adenovirus HPV therapeutic vaccine PRGN-2009
1区 · 医学
ArticleOA
作者: Sabzevari, Helen ; Brough, Douglas E. ; Pellom, Samuel T. ; Jochems, Caroline ; Schlom, Jeffrey ; Smalley Rumfield, Claire ; Poppe, Lisa K. ; Roller, Nicholas ; Morillon, Y. Maurice
There are approximately 44,000 cases of human papillomavirus–associated (HPV-associated) cancer each year in the United States, most commonly caused by HPV types 16 and 18. Prophylactic vaccines successfully prevent healthy people from acquiring HPV infections via HPV-specific antibodies. In order to treat established HPV-associated malignancies, however, new therapies are necessary. Multiple recombinant gorilla adenovirus HPV vaccine constructs were evaluated in NSG-β2m
–/–
peripheral blood mononuclear cell–humanized mice bearing SiHa, a human HPV16
+
cervical tumor, and/or in the syngeneic HPV16
+
TC-1 model. PRGN-2009 is a therapeutic gorilla adenovirus HPV vaccine containing multiple cytotoxic T cell epitopes of the viral oncoproteins HPV 16/18 E6 and E7, including T cell enhancer agonist epitopes. PRGN-2009 treatment reduced tumor volume and increased CD8
+
and CD4
+
T cells in the tumor microenvironment of humanized mice bearing the human cervical tumor SiHa. PRGN-2009 monotherapy in the syngeneic TC-1 model also reduced tumor volumes and weights, generated high levels of HPV16 E6–specific T cells, and increased multifunctional CD8
+
and CD4
+
T cells in the tumor microenvironment. These studies provide the first evaluation to our knowledge of a therapeutic gorilla adenovirus HPV vaccine, PRGN-2009, showing promising preclinical antitumor efficacy and induction of HPV-specific T cells, along with the rationale for its evaluation in clinical trials.
31
项与 PRGN-2009 相关的新闻（医药）2026-08-04
PAPZIMEOS® net revenue of $53.1 million in the second quarter of 2026, more than double the prior quarter, reflects accelerating commercial momentum and broad US adoption
PAPZIMEOS revenue propelled the Company to quarterly profitability
Cash, cash equivalents, and investments totaled $38.7 million as of June 30, 2026, which together with proceeds from PAPZIMEOS revenue, is expected to support cash flow break-even by the end of 2026
PAPZIMEOS patient hub enrollment reached well over 500 patients across major centers and community practices, demonstrating expanding reach and ease of administration across treatment settings
FDA granted PAPZIMEOS seven-year market exclusivity, providing long-term protection against prospective competition
Conference call scheduled for 4:30 PM ET today
GERMANTOWN, Md., Aug. 4, 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 second quarter 2026 financial results and business updates.
"We delivered a historic second quarter, with the rapid adoption of PAPZIMEOS demonstrating the strength of our groundbreaking science and innovative commercial strategy," said Helen Sabzevari, PhD, President and CEO of Precigen. "This momentum provides a strong foundation for our next phase of growth as we work to expand PAPZIMEOS globally and into the pediatric population. PAPZIMEOS demonstrates the AdenoVerse platform's ability to target HPV-associated diseases. We are building on that validated capability by advancing PRGN-2009 in HPV-driven cancers, with a pipeline update expected by year-end. With growing commercial momentum, a validated platform, and multiple opportunities ahead, we believe Precigen is well positioned to deliver sustained value for patients across various indications, the broader healthcare community, and our shareholders."
"We continue to see the key elements of the PAPZIMEOS commercial launch drive revenue growth: 100% field engagement with our initial target accounts, active patient and HCP campaigns, a permanent J-code supporting access and site activations, payer coverage across nearly all insured US lives, growing physician consensus reflected in a RRP position paper, and continued patient hub enrollments," said Phil Tennant, Chief Commercial Officer of Precigen. "This progress translated into strong quarterly revenue growth and increasing adoption across major medical centers and community practices as PAPZIMEOS becomes established as a new standard of care for adults with RRP. We remain focused on converting demand into treated patients and further expanding access to PAPZIMEOS across the RRP community."
KEY PROGRAM HIGHLIGHTS
PAPZIMEOS®
: First-line Standard of Care for the Treatment of Adults with RRP
PAPZIMEOS (zopapogene imadenovec-drba) is a non-replicating adenoviral vector-based immunotherapy designed to generate an immune response directed against HPV 6 and HPV 11 proteins in patients with recurrent respiratory papillomatosis (RRP). PAPZIMEOS has been approved by the US Food and Drug Administration (FDA) for the treatment of adults with RRP.
Broad US adoption: Well over 500 patients have registered through Precigen's patient hub, with additional patients outside of the hub being identified and receiving treatment as institutions support patient access directly and independently.
Market exclusivity: PAPZIMEOS was granted seven years of market exclusivity by the FDA, providing long-term protection against prospective competition. PAPZIMEOS remains the first and only approved therapy for adults with RRP and the only treatment designed to target the underlying cause of the disease.
Broad payer coverage: PAPZIMEOS has payer coverage across approximately 315 million US lives through private health plans, Medicare, and Medicaid, representing nearly 100% of insured lives nationwide.
Permanent J-code: The Centers for Medicare and Medicaid Services assigned permanent J-code, J3404, to PAPZIMEOS, effective April 1, 2026. The J-code provides a standard pathway for reimbursement, helps institutions process claims more efficiently, and reduces uncertainty for sites that are still building PAPZIMEOS into their workflows.
First-line standard of care: An expert position paper sponsored and published by the Recurrent Respiratory Papillomatosis Foundation and authored by 16 leading RRP physicians recommended PAPZIMEOS as the first-line standard of care for adults with RRP in the United States.
Redosing study enrolling patients: The Company's open-label study to evaluate redosing efficacy of zopapogene imadenovec in adults with RRP is currently enrolling (clinical trial identifier: NCT06538480).
MAA under review by the EMA: The European Medicines Agency (EMA) has validated and is reviewing the Marketing Authorization Application (MAA) submitted in November 2025 for zopapogene imadenovec for the treatment of adults with RRP. PAPZIMEOS has been granted orphan drug designation from 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.
A multicenter Phase 2 clinical trial of PRGN-2009 in combination with pembrolizumab in recurrent/metastatic cervical cancer is ongoing.
The Company plans to provide an update on progress across the AdenoVerse portfolio, including PRGN-2009, by the end of the year.
FINANCIAL RESULTS
"We are thrilled to report that Precigen achieved profitability in the second quarter, marking a significant milestone for the company. Net income was driven by strong PAPZIMEOS revenue of $53.1 million. As we progress through the third quarter of 2026, we are seeing continued growth in PAPZIMEOS demand," said Harry Thomasian Jr., Chief Financial Officer of Precigen. "Based upon our current revenue trajectory 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."
Second Quarter 2026 Financial Results Compared to Prior Year Period
Total revenues were $55.0 million for the three months ended June 30, 2026, an increase of $54.1 million compared to the three months ended June 30, 2025. The significant increase in total revenues was primarily due to the recording of commercial sales of PAPZIMEOS. Revenues related to the sale of PAPZIMEOS for the three months ended June 30, 2026 were $53.1 million.
Cost of products and services increased by $1.7 million, compared to the three months ended June 30, 2025, almost entirely due to costs related to the recording of commercial sales of PAPZIMEOS following its FDA approval in August 2025. Prior to regulatory approval, costs associated with the production of PAPZIMEOS were expensed as research and development in accordance with the Company's accounting policy. Upon FDA approval and the commencement of commercial sales, these costs are now capitalized as inventory and recognized in cost of product and services as product is sold.
R&D expenses decreased by $4.2 million, compared to the three months ended June 30, 2025, primarily due to the change in the accounting treatment of PAPZIMEOS manufacturing costs. The Company expects that R&D expenses will increase as the year progresses.
SG&A expenses increased by $6.1 million, compared to the three months ended June 30, 2025. This increase was primarily driven by commercial activities related to PAPZIMEOS following its FDA approval in August 2025. The higher expenses reflect increased costs to support commercialization, expanded marketing and promotional activities to drive product awareness and adoption, and increased personnel costs, including stock compensation expense.
In the three months ended June 30, 2025, the Company recorded $3.9 million in impairment related to its Exemplar reporting unit with no comparable charge in the second quarter of 2026.
Total other expense, net was $2.6 million for the three months ended June 30, 2026 compared to other income, net of $5.1 million for the three months ended June 30, 2025, a change of $7.7 million. This change was primarily attributable to the absence of a $4.5 million gain related to the decrease in the fair value of warrant liabilities that was recorded in the prior-year period. The remaining change primarily relates to an increase of $3.0 million in interest expense related to long term debt that originated in the third quarter of 2025.
Net income was $20.1 million, or $0.06 per basic and $0.05 per diluted share for the three months ended June 30, 2026, compared to a net loss of $26.6 million, or $(0.09) per basic and diluted share, for the three months ended June 30, 2025.
First Six Months 2026 Financial Results Compared to Prior Year Period
Total revenues were $78.2 million for the six months ended June 30, 2026, an increase of $76.0 million compared to the six months ended June 30, 2025. The significant increase in total revenues was primarily due to the recording of commercial sales of PAPZIMEOS. Revenues related to the sale of PAPZIMEOS for the six months ended June 30, 2026 were $74.7 million.
Cost of products and services increased by $3.2 million, compared to the six months ended June 30, 2025, almost entirely due to costs related to the recording of commercial sales of PAPZIMEOS following its FDA approval in August 2025. Prior to regulatory approval, costs associated with the production of PAPZIMEOS were expensed as research and development in accordance with the Company's accounting policy. Upon FDA approval and the commencement of commercial sales, these costs are now capitalized as inventory and recognized in cost of product and services as product is sold.
R&D expenses decreased by $9.0 million, compared to the six months ended June 30, 2025, primarily due to the change in the accounting treatment of PAPZIMEOS manufacturing costs. The Company expects that R&D expenses will increase as the year progresses.
SG&A expenses increased by $14.8 million, compared to the six months ended June 30, 2025. This increase was primarily driven by commercial activities related to PAPZIMEOS following its FDA approval in August 2025. The higher expenses reflect increased costs to support commercialization, expanded marketing and promotional activities to drive product awareness and adoption, and increased personnel costs, including stock compensation expense.
In the six months ended June 30, 2025, the Company recorded $3.9 million in impairment related to its Exemplar reporting unit with no comparable charge in the six months ended June 30, 2026.
Total other expense, net decreased by $21.9 million, compared to the six months ended June 30, 2025. This decrease was primarily attributable to the absence of a $28.0 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 $5.9 million in interest expense related to long-term debt that was entered into in the third quarter of 2025.
Net income was $12.1 million, or $0.03 per basic and diluted share for the six months ended June 30, 2026, compared to a net loss of $80.8 million, or $(0.27) per basic and diluted share, for the six months ended June 30, 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 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 quarterly profitability and 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
[email protected]
Media Contact:
Donelle M. Gregory
[email protected]
SOURCE Precigen, Inc.
21%
more press release views with
Request a Demo
临床2期孤儿药上市批准免疫疗法财报
2026-05-24
·网易号
华尔街最近盯上了一只曾经无人问津的低价医药股。Precigen（NASDAQ:PGEN）在5月中旬发布的一季度财报，让两家投行在同一天上调了目标价——H.C. Wainwright从10美元调到11美元，Citizens JMP则从9美元直接跳到11美元。这种同步唱多的场面，在生物科技小盘股里并不常见。真正让分析师改观的，是一款叫PAPZIMEOS的新药。这是一款针对罕见病免疫缺陷的基因疗法，一季度销售额2160万美元，是公司历史上第一个真正意义上的商业化产品。要知道，就在一年前，Precigen还在烧钱研发的泥潭里挣扎，每股亏损18美分；今年一季度，亏损已经收窄到2美分。Citizens JMP的报告里用了三个词评价这次上市：临床数据扎实、商业准备充分、执行到位。翻译成大白话就是——这药确实管用，公司也没掉链子。CEO Helen Sabzevari在电话会上透露，团队正在把销售网络从美国本土往国际市场和儿科适应症拓展。CFO Harry Thomasian Jr.则给了一个更具体的信号：二季度开局延续了强劲势头，2026年底有望实现现金流转正。账面上的数字也在印证这个故事。截至3月底，Precigen持有现金及等价物5670万美元，如果算上2570万美元的PAPZIMEOS应收账款，实际流动性更接近8200万美元。管理层明确表示，现有资金加上预期销售进账，足够撑到盈亏平衡点，不需要新一轮稀释股权的融资。对于一只股价长期在个位数徘徊的低价股来说，"不用再融资"这五个字，本身就是重大利好。不过PAPZIMEOS并不是Precigen的全部筹码。公司手里还攥着一条叫AdenoVerse的技术平台，核心产品PRGN-2009正在针对HPV相关癌症开展临床。这条管线的逻辑很清晰：用基因编辑手段激活患者自身免疫系统，攻击由人乳头瘤病毒引发的肿瘤。目前数据还在早期，但市场愿意给这种平台型技术溢价——毕竟一旦走通，适应症可以横向扩展。风险当然存在。PAPZIMEOS面对的是极小众患者群体，天花板肉眼可见；基因疗法的生产成本和定价策略始终是行业痛点；而PRGN-2009距离商业化至少还有几年路要走。但换个角度看，这些风险已经部分反映在股价里。两家投行同步把目标价定在11美元，隐含的是对现有产品兑现能力和平台价值的双重认可。生物医药投资向来是高风险高回报的游戏。Precigen的特殊之处在于，它正在从"讲故事"阶段跨入"数钱"阶段——这个转折点往往伴随着估值体系的重构。对于愿意承受波动的长期投资者，这种蜕变期的公司或许比纯粹的早期标的更值得研究。
2026-05-13
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 US
Patient hub enrollment continues to gain traction, with approximately 400 patients currently enrolled; a notable 25% of which are from the community setting, underscoring the breadth of PAPZIMEOS's reach and ease of administration
Updated durability of response data for PAPZIMEOS will be presented at the upcoming ASCO Annual Meeting
RRP Awareness Day will be hosted alongside the Recurrent Respiratory Papillomatosis Foundation on June 11 for the third consecutive year, reflecting the Company's ongoing commitment to the recurrent respiratory papillomatosis (RRP) community
The Company continues to advance PRGN-2009 in HPV-associated cancers and plans to provide an AdenoVerse® pipeline update by end of year
Cash, cash equivalents, and investments totaled $56.7 million 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 2026
Conference call scheduled for 4:30 PM ET today
GERMANTOWN, Md., May 13, 2026 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, today announced first quarter 2026 financial results and business updates.
"We are thrilled with the strength of the PAPZIMEOS launch and the pace of revenue growth as we drive broad commercial success across the US and work toward expanded market opportunities in additional geographies and the pediatric patient population," said Helen Sabzevari, PhD, President and CEO of Precigen. "Looking ahead, we are excited to advance the next chapter of our AdenoVerse platform through the continued development of PRGN-2009 in HPV-associated cancers, and look forward to sharing more details on our broader pipeline progress later this year. We are also proud to once again collaborate with the Recurrent Respiratory Papillomatosis Foundation in recognizing RRP Awareness Day for the third consecutive year on June 11, reflecting our deep and long-standing commitment to the RRP community. This year's event carries particular significance as adult patients now have access to an approved treatment, PAPZIMEOS, for the first time in the more than 100-year history of this disease."
"We are encouraged by the strong progress we are seeing as PAPZIMEOS continues to gain traction, with approximately 400 patients currently enrolled in the PAPZIMEOS patient hub, of which a noteworthy 25% are from the community setting," said Phil Tennant, Chief Commercial Officer of Precigen. "We are focused on converting hub enrollment into treated patients, and we look forward to building on this progress in the second quarter and beyond as more sites become activated, the impact of the permanent J-code takes hold, and our targeted site support helps deliver a seamless journey to treatment."
KEY PROGRAM HIGHLIGHTS
PAPZIMEOS™:
First-line Standard of Care for the Treatment of Adults with RRP
PAPZIMEOS (zopapogene imadenovec-drba) is a non-replicating adenoviral vector-based immunotherapy designed to generate an immune response directed against HPV 6 and HPV 11 proteins in patients with RRP. In August 2025, the US Food and Drug Administration (FDA) granted full approval of PAPZIMEOS with a broad label for the treatment of adults with RRP. PAPZIMEOS is the first and only FDA-approved therapy for the treatment of adults with RRP and the first treatment that addresses the root cause of RRP.
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 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
[email protected]
Media Contact:
Donelle M. Gregory
[email protected]
SOURCE Precigen, Inc.
21%
more press release views with
Request a Demo
孤儿药临床2期免疫疗法上市批准
100 项与 PRGN-2009 相关的药物交易
登录后查看更多信息
研发状态
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| HPV相关癌症 | 临床2期 | 美国 | 2025-11-11 | |
| 子宫颈转移癌 | 临床2期 | 美国 | 2025-11-11 | |
| 复发性宫颈癌 | 临床2期 | 美国 | 2025-11-11 | |
| 转移性宫颈癌 | 临床2期 | 美国 | - | |
| 口咽部鳞状细胞癌 | 临床2期 | 美国 | - |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床1/2期 | 39 | Human Papillomavirus Vaccine (HPV) vaccine+bintrafusp alfa (All Participants in Phase I) | 範觸艱繭觸鑰糧膚窪願 = 觸醖鹹鏇繭夢襯構繭築 鹽積網構繭夢獵膚積築 (鹽窪構遞鏇淵築積選鑰, 構憲壓夢齋遞積淵壓餘 ~ 鹹願繭艱窪壓選夢積築) | - | 2026-08-18 | ||
HPV vaccine (Phase I Cohort 1, Arm 1A, Dose Level 1) | 繭糧觸築襯鹹蓋廠廠餘 = 餘憲壓膚鹹觸膚醖築製 獵壓鹹築艱壓壓觸膚鹽 (網蓋鹽蓋築製衊餘選憲, 窪鑰蓋鹽鹽鹹遞鏇顧鑰 ~ 鹽鬱廠餘膚襯淵製廠蓋) 更多 | ||||||
临床1期 | HPV相关癌症 HPV16 | - | 築繭艱蓋製壓觸鬱壓膚(觸觸衊積築遞顧醖選鬱) = 構構鏇遞顧鬱窪糧構壓 願簾簾範鑰繭繭壓願網 (積憲鬱繭鹹獵淵構鑰願, 2.9 ~ 26.8) | 积极 | 2025-03-21 | ||
PRGN-2009 + Bintrafusp alfa | 遞襯範鏇鹽餘淵鹹餘範(範憲選壓鹹鬱窪憲廠醖) = 夢顧鹽廠鏇窪蓋觸遞網 築餘簾繭衊鬱顧夢獵鹽 (膚夢顧網繭艱淵糧淵蓋 ) 更多 | ||||||
临床1期 | 17 | (dose escalation part, DEP) | 醖選鑰鹹願壓網膚積鬱(構積齋觸網網製窪獵壓) = PRGN-2009 5x10^11 particle units (PU) SC Q2W 壓願蓋窪鏇繭鹽鑰淵膚 (積簾範範遞餘顧餘遞鹽 ) 更多 | 积极 | 2023-05-26 | ||
(combination part, CP) | |||||||
临床1/2期 | 6 | 鹹顧襯艱醖繭憲顧製網(選遞觸襯鹽醖壓網淵衊) = 網網繭選蓋構夢廠鑰顧 範蓋齋鏇襯淵淵網夢鏇 (齋淵築襯獵夢壓觸範糧 ) 更多 | 积极 | 2021-11-11 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
提出任何生物医药研究问题
让每一步生物医药决策都精准制胜
基于十亿级生物数据与全球情报的精准 AI，赋能早期药物发现
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即接入生物医药数据包
智慧芽新药库数据也通过智慧芽开放平台，以MCP或API服务形式对外开放。立即使用我们的MCP服务定制您的LLM智能体。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用