Press release
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NEWS RELEASE INOVIO Announces FDA Accelerated Approval of VOCERYQ™, an Immunotherapy to Reduce the Frequency of Surgery in Adults with Recurrent Respiratory Papillomatosis (RRP) 2026-10-30 INOVIO delivers a new nonsurgical treatment op on with a broad indica on for adults living with RRP, a rare and debilita ng disease that o en requires surgery VOCERYQ™ is a plasmid DNA-based immunotherapy that targets the root cause of RRP: HPV-6 and HPV-11 INOVIO expects to make VOCERYQ available to order and ship in approximately 60 days, with full commercial launch in the first quarter of 2027 VOCERYQ represents the first U.S. FDA approved DNA medicine, valida ng INOVIO's novel pla orm technology INOVIO will host a conference call Monday, November 2, 2026 at 8:00 AM ET PLYMOUTH MEETING, Pa., Oct. 30, 2026 /PRNewswire/ -- INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infec ous diseases, today announced that the U.S. Food and Drug Administra on (FDA) has granted accelerated approval for VOCERYQ (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd), previously referred to as INO-3107, to reduce the frequency of surgery in adults with RRP. This indica on is approved under the accelerated approval program based on demonstrated complete response defined as no requirement for surgical interven on in the 12 months a er treatment in the efficacy popula on. Con nued approval for this indica on may be con ngent on verifica on and descrip on of clinical benefit in a confirmatory study(ies). "With the approval of VOCERYQ, we believe our DNA medicine pla orm has the poten al to transform the treatment paradigm for RRP by offering a pa ent-centric treatment op on. VOCERYQ is designed to deliver what we understand ma ers most to pa ents, which is the reduc on of the surgical burden caused by RRP," said Dr. Jacqueline Shea, INOVIO's President and Chief Execu ve Officer. "INOVIO is grateful to the pa ents, study inves gators, and the RRP Founda on, who helped make this achievement possible, and also to the FDA, who recognized the significant unmet need in this pa ent community. We would like to thank our dedicated INOVIO team and their ongoing commitment to pa ents. We look forward to delivering VOCERYQ to the RRP community and believe it has the poten al to become a new standard of care for this devasta ng disease." 1
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The approval is supported by data from INOVIO's RRP-001 study which evaluated VOCERYQ in 32 adult pa ents with RRP who had two or more surgeries in the year prior to treatment. During the VOCERYQ dosing window, no addi onal papilloma surgical excisions were required in the protocol. Of the 32 pa ents, 26 pa ents required 3 or more surgeries for papilloma excision in the 12 months prior to treatment and were included in the efficacy evalua on (median number of surgical excisions in the 12 months prior to the first dose in the efficacy popula on was 4.5 (range: 3 to 8)). Seven out of the 26 pa ents (27% [95% CI: 12; 48%]) demonstrated a complete response, defined as requiring no surgical excision of papillomas, a er 12 months of follow up, which is not expected as part of the natural history of the disease when untreated. The complete clinical data for VOCERYQ were published in Nature Communica ons and in The Laryngoscope, the leading journal for the specialists who treat RRP. "This new FDA-approved therapy brings us an important step closer to ensuring every RRP pa ent has access to a non-surgical treatment op on that works for them. In reaching this milestone, we have shown that pa ent voices ma er in the drug development process," said Kim McClellan, President of the RRP Founda on. "Pa ents have o en had to endure repeated surgeries to control their RRP disease, but now thanks to the INOVIO team and the pa ents and inves gators involved in the clinical development program for VOCERYQ, a new op on is available that has the poten al to further transform the treatment landscape for RRP pa ents. We look forward to con nuing to work with clinicians, regulators and our partners in the healthcare industry to further improve the quality of life for those living with RRP." Dr. Simon Best, Associate Professor of Otolaryngology at Johns Hopkins University and a lead inves gator for INOVIO's RRP-001 study, said, "The approval of VOCERYQ is an important step in improving the quality of life for RRP pa ents as every surgery carries the risk of laryngeal injury. I believe it is in the best interest of RRP pa ents that the standard of care quickly transi on away from surgical interven ons to immunotherapy a er RRP is diagnosed." VOCERYQ was found to be well tolerated, with the most common adverse reac ons (incidence >5%) including injec on site reac ons, headache, fa gue, hypertension, nausea and dizziness. Most treatment-related adverse reac ons were grade 1 and 2 and transient. There were no grade 4 or 5 common adverse events. All 32 pa ents completed the study. See addi onal Important Safety Informa on below. To verify the clinical benefit of VOCERYQ, a confirmatory study is expected to be conducted. The FDA requires INOVIO to submit a dra protocol for the study by the end of 2026 with the expecta on of aligning on a final protocol by mid-2027. VOCERYQ was approved in combina on with CELLECTRA® 5PSP, INOVIO's proprietary DNA medicine delivery device. INOVIO expects to make VOCERYQ available to order and ship in approximately 60 days and an cipates full field deployment during the first quarter of 2027. INOVIO has engaged Syneos Health to support the recruitment and deployment of our medical and commercial field teams. Conference Call INOVIO will host a conference call on Monday, November 2 at 8:00 AM ET to provide addi onal details regarding the approval, including key aspects of the label and commercializa on. You can watch the webcast at h ps://app.webinar.net/6LNlx7kxyqd. 2
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Event details can be found on INOVIO's website in the Events & Presenta ons sec on at h ps://ir.inovio.com/events-and- presenta ons/default.aspx. Conference Call Dial-In Number Local/Interna onal (toll): 1-646-357-8785 North American Toll Free: 1-800-836-8184 About RRP RRP is a rare, debilita ng disease caused primarily by HPV-6 and/or HPV-11. RRP is characterized by the development of small, wart- like growths, or papillomas, in the respiratory tract. While papillomas are generally benign, they can cause severe, life-threatening airway obstruc on and respiratory complica ons. RRP can also significantly affect quality of life for pa ents by affec ng the voice box, limi ng the ability to speak effec vely. Surgery to remove papillomas is the current standard of care for RRP; however, the papillomas o en grow back. INOVIO's market research to date with pa ents and healthcare professionals indicates that a reduc on of even one surgery ma ers, because every surgery poses a significant risk of causing permanent damage to the vocal cords and comes with poten al costs to the pa ent, including adverse impacts to both quality of life and finances. Based on ongoing analysis of claims data, INOVIO believes there is a prevalent popula on of at least 25,000 pa ents with RRP in the United States, with addi onal pa ents diagnosed each year. About VOCERYQ™ VOCERYQ™ is a plasmid DNA-based immunotherapy designed to reduce the frequency of surgery for adults with RRP. VOCERYQ targets the root cause of RRP by genera ng an immune response using DNA plasmids that encode for HPV-6 and HPV-11 an gens. VOCERYQ is administered using the CELLECTRA® delivery device. Following a standard-of-care surgical debulking of visible papilloma prior to the ini al administra on of VOCERYQ, no addi onal surgical interven on is required as part of the 9-week dosing regimen. The FDA previously granted VOCERYQ both Orphan Drug and Breakthrough Therapy designa ons, and the European Commission granted INO-3107 Orphan Drug designa on. Learn more at www.voceryq.com. INDICATION VOCERYQ is indicated to reduce the frequency of surgical papilloma excisions in adults with recurrent respiratory papillomatosis. This indica on is approved under accelerated approval based on reduc on in the frequency of surgical papilloma excisions. Con nued approval for this indica on may be con ngent upon verifica on and descrip on of clinical benefit in confirmatory study(ies). 3
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IMPORTANT SAFETY INFORMATION Warnings & Precau ons: Injec on site reac ons have occurred with VOCERYQ injec on. Monitor pa ents for local site reac ons for at least 30 minutes a er treatment and manage accordingly. Electropora on Related Adverse Reac ons: Procedure-related effects including muscle contrac ons, transient bleeding, and vasovagal reac ons may occur. Avoid use in pa ents with ipsilateral ICDs/pacemakers, metal implants or skin abnormali es at treatment site. Adverse Reac ons: Most common adverse reac ons (incidence >5%) are injec on site reac ons, headache, fa gue, hypertension, nausea and dizziness. Please go to www.voceryq.com for full Prescribing Informa on, including Pa ent Informa on. About INOVIO's DNA Medicines Pla orm INOVIO's DNA medicines pla orm has two innova ve components: precisely designed DNA plasmids, delivered by INOVIO's proprietary medical device, CELLECTRA. INOVIO uses proprietary technology to design its DNA plasmids, which are small circular DNA molecules that enable the body's cells to produce specific proteins to target and fight disease. INOVIO's proprietary CELLECTRA delivery devices are designed to op mally deliver its DNA medicines to the body's cells without requiring chemical adjuvants or lipid nanopar cles and without the risk of the an -vector response historically seen with viral vector pla orms. About INOVIO INOVIO is a biotechnology company focused on developing and commercializing innova ve DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infec ous diseases. INOVIO's technology op mizes the design and delivery of DNA medicines that enable the body to manufacture its own disease-figh ng tools. For more informa on, visit www.inovio.com and follow us on LinkedIn and X (formerly known as Twi er). Forward-Looking Statements This press release contains certain forward-looking statements within the meaning of the Private Securi es Li ga on Reform Act of 1995, including statements rela ng to our business, including the ming and success of preclinical studies and clinical studies; the ability to obtain and maintain regulatory approval of our product candidates, including that con nued approval for VOCERYQ may be con ngent on verifica on of clinical benefit in a confirmatory study, and the ming of submission of a dra and final protocol for such confirmatory study; the poten al benefits of VOCERYQ, including our belief that VOCERYQ has a posi vely differen ated product profile and the poten al to become the preferred product by pa ents and their physicians, and the an cipated impact of VOCERYQ on treatment prac ces and outcomes for pa ents with RRP; the scope, progress and expansion of developing and commercializing our product candidates, including the an cipated commercial launch and field deployment meline for VOCERYQ and our engagement of Syneos Health to support such commercializa on efforts; our es mate of the prevalent popula on of pa ents with RRP in the United States; and our an cipated growth strategies. Actual events or results may differ from the 4
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expecta ons set forth herein as a result of a number of factors, including uncertain es inherent in pre-clinical studies, clinical studies, product development programs and commercializa on ac vi es and outcomes, the availability of funding to support con nuing research and studies in an effort to prove safety and efficacy of electropora on technology as a delivery mechanism or develop viable DNA medicines, our ability to support our pipeline of DNA medicine products, the ability of our collaborators to a ain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royal es, the adequacy of our capital resources, the availability or poten al availability of alterna ve therapies or treatments for the condi ons targeted by us or collaborators, including alterna ves that may be more efficacious or cost effec ve than any therapy or treatment that we and our collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide us with meaningful protec on from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether we can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by poten al corporate or other partners or collaborators, capital market condi ons, the impact of government healthcare proposals and other factors set forth in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2026 and other filings we make from me to me with the Securi es and Exchange Commission. There can be no assurance that any product candidate in our pipeline will be successfully developed, manufactured, or commercialized, that the results of clinical studies will be suppor ve of regulatory approvals required to market products, or that any of the forward-looking informa on provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and we undertake no obliga on to update or revise these statements, except as may be required by law. Contacts Media: Josephine Gala oto - ICR Healthcare, inoviopr@icrhealthcare.com Investors: Peter Vozzo - ICR Healthcare, (443) 213-0505, peter.vozzo@icrhealthcare.com View original content to download mul media:h ps://www.prnewswire.com/news-releases/inovio-announces-fda-accelerated- approval-of-voceryq-an-immunotherapy-to-reduce-the-frequency-of-surgery-in-adults-with-recurrent-respiratory-papillomatosis- rrp-302925406.html SOURCE INOVIO Pharmaceu cals, Inc. 5