INOVIO gets FDA accelerated approval for VOCERYQ
VOCERYQ's continued approval may be contingent on confirming clinical benefit; the FDA requires a draft study protocol by the end of 2026.
Sentiment and the balance of points
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Rhea-AI Filing Summary
INOVIO Pharmaceuticals, Inc. (INO) announced that the FDA granted accelerated approval for VOCERYQ (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) to reduce the frequency of surgical papilloma excisions in adults with recurrent respiratory papillomatosis (RRP). The indication was approved under accelerated approval based on reduced excisions; continued approval may be contingent on verification and description of clinical benefit in confirmatory studies. In the 26-patient efficacy population, 7 patients (27%; 95% CI: 12%–48%) had no surgical excision in the 12 months after treatment; the median number of surgical excisions in the 12 months before first dose was 4.5.
VOCERYQ was approved in combination with CELLECTRA 5PSP. INOVIO expects to make it available to order and ship in approximately 60 days and anticipates full field deployment during the first quarter of 2027. The FDA requires a draft confirmatory-study protocol by the end of 2026, with alignment on a final protocol expected by mid-2027. All 32 patients completed the study. The most common adverse reactions (incidence greater than 5%) included injection-site reactions, headache, fatigue, hypertension, nausea and dizziness; no grade 4 or 5 common adverse events were reported.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Major pointVOCERYQ received FDA accelerated approval for adults with RRP on October 30, 2026.
Negative
- None.
8-K Event Classification
Key Figures
Key Terms
accelerated approval regulatory
complete response medical
confirmatory study regulatory
electroporation technical
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did the FDA approve for INO?
How many RRP patients had no surgery after VOCERYQ treatment?
When will INO make VOCERYQ available?
When is INO's confirmatory-study protocol due?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
CURRENT REPORT
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| Item 7.01 | Regulation FD Disclosure. |
As described in Item 8.01 below, on October 30, 2026, Inovio Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (the “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 Recurrent Respiratory Papillomatosis (“RRP”). The press release is furnished as Exhibit 99.1 hereto.
On November 2, 2026, the Company plans to make a corporate presentation via teleconference to discuss the approval of VOCERYQ™. The slides used during the presentation are furnished as Exhibit 99.2 hereto and are posted on the Company’s corporate website at www.inovio.com under “Investor Relations—Events and Presentations.”
The information contained in this Item 7.01, including Exhibits 99.1 and 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any incorporation language in such a filing, except as expressly set forth by specific reference in such a filing. Information contained in, or that can be accessed through, our website is not a part of, and shall not be incorporated by reference into, this report. We have included our website address in this report solely as an inactive textual reference.
| Item 8.01 | Other Events |
On October 30, 2026, the Company announced that the FDA has granted accelerated approval for VOCERYQ™ (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) to reduce the frequency of surgery in adults with RRP. This indication is approved under the accelerated approval program based on demonstrated complete response, defined as no requirement for surgical intervention in the 12 months after treatment in the efficacy population. Continued approval for this indication may be contingent on verification and description of clinical benefit in one or more confirmatory studies.
To verify the clinical benefit of VOCERYQ, a confirmatory study is expected to be conducted. The FDA requires the Company to submit a draft protocol for the study by the end of 2026, with the expectation of aligning on a final protocol by mid-2027.
VOCERYQ was approved in combination with CELLECTRA® 5PSP, the Company’s proprietary DNA medicine delivery device. The Company expects to make VOCERYQ available to order and ship in approximately 60 days and anticipates full field deployment during the first quarter of 2027.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit Number |
Exhibit Description | |
| 99.1 | Press Release. | |
| 99.2 | Corporate Presentation. | |
| 104 | Cover Page Interactive Data File (formatted as inline XBRL). | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| INOVIO PHARMACEUTICALS, INC. | ||||||
| Date: November 2, 2026 | /s/ Peter Kies | |||||
| Peter Kies | ||||||
| Chief Financial Officer | ||||||
Exhibit 99.1
INOVIO Announces FDA Accelerated Approval of VOCERYQ™, an Immunotherapy to
Reduce the Frequency of Surgery in Adults with Recurrent Respiratory Papillomatosis (RRP)
| • | INOVIO delivers a new nonsurgical treatment option with a broad indication for adults living with RRP, a rare and debilitating disease that often 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, validating INOVIO’s novel platform technology |
| • | INOVIO will host a conference call Monday, November 2, 2026 at 8:00 AM ET |
PLYMOUTH MEETING, PA – October 30, 2026 – 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 infectious diseases, today announced that the U.S. Food and Drug Administration (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 indication is approved under the accelerated approval program based on demonstrated complete response defined as no requirement for surgical intervention in the 12 months after treatment in the efficacy population. Continued approval for this indication may be contingent on verification and description of clinical benefit in a confirmatory study(ies).
“With the approval of VOCERYQ, we believe our DNA medicine platform has the potential to transform the treatment paradigm for RRP by offering a patient-centric treatment option. VOCERYQ is designed to deliver what we understand matters most to patients, which is the reduction of the surgical burden caused by RRP,” said Dr. Jacqueline Shea, INOVIO’s President and Chief Executive Officer. “INOVIO is grateful to the patients, study investigators, and the RRP Foundation, who helped make this achievement possible, and also to the FDA, who recognized the significant unmet need in this patient community. We would like to thank our dedicated INOVIO team and their ongoing commitment to patients. We look forward to delivering VOCERYQ to the RRP community and believe it has the potential to become a new standard of care for this devastating disease.”
The approval is supported by data from INOVIO’s RRP-001 study which evaluated VOCERYQ in 32 adult patients with RRP who had two or more surgeries in the year prior to treatment. During the VOCERYQ dosing window, no additional papilloma surgical excisions were required in the protocol. Of the 32 patients, 26 patients required 3 or more surgeries for papilloma excision in the 12 months prior to treatment and were included in the efficacy evaluation (median number of surgical excisions in the 12 months prior to the first dose in the efficacy population was 4.5 (range: 3 to 8)). Seven out of the 26 patients (27% [95% CI: 12; 48%]) demonstrated a complete response, defined as requiring no surgical excision of papillomas, after 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 Communications 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 patient has access to a non-surgical treatment option that works for them. In reaching this milestone, we have shown that patient voices matter in the drug development process,” said Kim McClellan, President of the RRP Foundation. “Patients have often had to endure repeated surgeries to control their RRP disease, but now thanks to the INOVIO team and the patients and investigators involved in the clinical development program for VOCERYQ, a new option is available that has the potential to further transform the treatment landscape for RRP patients. We look forward to continuing 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 investigator for INOVIO’s RRP-001 study, said, “The approval of VOCERYQ is an important step in improving the quality of life for RRP patients as every surgery carries the risk of laryngeal injury. I believe it is in the best interest of RRP patients that the standard of care quickly transition away from surgical interventions to immunotherapy after RRP is diagnosed.”
VOCERYQ was found to be well tolerated, with the most common adverse reactions (incidence >5%) including injection site reactions, headache, fatigue, hypertension, nausea and dizziness. Most treatment-related adverse reactions were grade 1 and 2 and transient. There were no grade 4 or 5 common adverse events. All 32 patients completed the study. See additional Important Safety Information below.
To verify the clinical benefit of VOCERYQ, a confirmatory study is expected to be conducted. The FDA requires INOVIO to submit a draft protocol for the study by the end of 2026 with the expectation of aligning on a final protocol by mid-2027.
VOCERYQ was approved in combination 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 anticipates 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 Monday, November 2, 2026 at 8:00 AM ET to provide additional details regarding the approval, including key aspects of the label and commercialization. You can watch the webcast at h ttp s://app.we binar.net/6LNlx7kxqd. Event details can be found on INOVIO’s website in the Events & Presentations section at h ttp s://ir.inovio.com/events-and-presentations/default.aspx.
Conference Call Dial-In Number
Local/International (toll): 1-646-357-8785
North American Toll Free: 1-800-836-8184
About RRP
RRP is a rare, debilitating 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 obstruction and respiratory complications. RRP can also significantly affect quality of life for patients by affecting the voice box, limiting the ability to speak effectively. Surgery to remove papillomas is the current standard of care for RRP; however, the papillomas often grow back. INOVIO’s market research to date with patients and healthcare professionals indicates that a reduction of even one surgery matters, because every surgery poses a significant risk of causing permanent damage to the vocal cords and comes with potential costs to the patient, including adverse impacts to both quality of life and finances. Based on ongoing analysis of claims data, INOVIO believes there is a prevalent population of at least 25,000 patients with RRP in the United States, with additional patients 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 generating an immune response using DNA plasmids that encode for HPV-6 and HPV-11 antigens. VOCERYQ is administered using the CELLECTRA® delivery device. Following a standard-of-care surgical debulking of visible papilloma prior to the initial administration of VOCERYQ, no additional surgical intervention is required as part of the 9-week dosing regimen.
The FDA previously granted VOCERYQ both Orphan Drug and Breakthrough Therapy designations, and the European Commission granted INO-3107 Orphan Drug designation.
Learn more at w ww.voceryq.com.
INDICATION
VOCERYQ is indicated to reduce the frequency of surgical papilloma excisions in adults with recurrent respiratory papillomatosis.
This indication is approved under accelerated approval based on reduction in the frequency of surgical papilloma excisions. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory study(ies).
IMPORTANT SAFETY INFORMATION
Warnings & Precautions: Injection site reactions have occurred with VOCERYQ injection. Monitor patients for local site reactions for at least 30 minutes after treatment and manage accordingly.
Electroporation Related Adverse Reactions: Procedure-related effects including muscle contractions, transient bleeding, and vasovagal reactions may occur. Avoid use in patients with ipsilateral ICDs/pacemakers, metal implants or skin abnormalities at treatment site.
Adverse Reactions: Most common adverse reactions (incidence >5%) are injection site reactions, headache, fatigue, hypertension, nausea and dizziness.
Please go to w ww.voceryq.com for full Prescribing Information, including Patient Information.
About INOVIO’s DNA Medicines Platform
INOVIO’s DNA medicines platform has two innovative 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 optimally deliver its DNA medicines to the body’s cells without requiring chemical adjuvants or lipid nanoparticles and without the risk of the anti-vector response historically seen with viral vector platforms.
About INOVIO
INOVIO is a biotechnology company focused on developing and commercializing innovative DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO’s technology optimizes the design and delivery of DNA medicines that enable the body to manufacture its own disease-fighting tools. For more information, visit w ww.inovio.com and follow us on LinkedIn and X (formerly known as Twitter).
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to our business, including the timing and success of preclinical studies and clinical studies; the ability to obtain and maintain regulatory approval of our product candidates, including that continued approval for VOCERYQ may be contingent on verification of clinical benefit in a confirmatory study, and the timing of submission of a draft and final protocol for such confirmatory study; the potential benefits of VOCERYQ, including our belief that VOCERYQ has a positively differentiated product profile and the potential to become the preferred product by patients and their physicians, and the anticipated impact of VOCERYQ on treatment practices and outcomes for patients with RRP; the scope, progress and expansion of developing and commercializing our product candidates, including the anticipated commercial launch and field deployment timeline for VOCERYQ and our engagement of Syneos Health to support such commercialization efforts; our estimate of the prevalent population of patients with RRP in the United States; and our anticipated growth strategies. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical studies, product development programs and commercialization activities and outcomes, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation 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 attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or collaborators, including alternatives that may be more efficacious or cost effective 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 protection 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 potential corporate or other partners or collaborators, capital market conditions, 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 time to time with the Securities 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 supportive of regulatory approvals required to market products, or that any of the forward-looking information provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and we undertake no obligation to update or revise these statements, except as may be required by law.
Contacts
Media: Josephine Galatioto - ICR Healthcare, inoviopr@icrhealthcare.com
Investors: Peter Vozzo - ICR Healthcare, (443) 213-0505, peter.vozzo@icrhealthcare.com
FDA Accelerated Approval of VOCERYQ™ (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) Investor Call November 2, 2026 Exhibit 99.2
Agenda for VOCERYQ™ Approval Call Introduction Jacqueline Shea, PhD, President & Chief Executive Officer Prescribing Information and Label Details Michael Sumner, MBBS, MBA, Chief Medical Officer Commercial Launch Plans Steve Egge, MBA, Chief Commercial Officer VOCERYQ™ and Platform Potential Jacqueline Shea, PhD, President & Chief Executive Officer
This presentation includes statements that are, or may be deemed, “forward-looking statements,” within the meaning of Section 27A of the Securities Act of 1933, as amended. All statements, other than statements of historical facts, included in this presentation regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “target,” “design,” “estimate,” “predict,” “opportunity,” “proposition,” “strategy,” “potential,” “plan” or the negative of these terms and similar expressions intended to identify forward-looking statements. You should not place undue reliance on these forward-looking statements. Forward-looking statements include, but are not limited to, statements about: the timing and success of preclinical studies and clinical trials; the ability to maintain regulatory approval of VOCERYQ™ (formerly referred to as INO-3107), including our belief regarding the competitive advantages of VOCERYQ™ relative to existing treatments; the anticipated timing, scope and success of our commercial launch of VOCERYQ™, including anticipated payer coverage, field deployment and manufacturing timelines; the design, timing and FDA alignment around our planned confirmatory study(ies); our expected manufacturing capabilities; our plans to expand the VOCERYQ™ program through additional treatment strategies; our belief that VOCERYQ™ has the potential to become the preferred treatment and new standard of care for patients with RRP; our expectations regarding competition; the size and growth of the potential markets for VOCERYQ™ and the ability to serve those markets; the rate and degree of market acceptance of any of VOCERYQ™; our anticipated growth strategies; the anticipated trends and challenges in our business and the market in which we operate; our expectations regarding federal, state and foreign regulatory requirements; and other factors that are described in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of our Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, which has been filed with the Securities and Exchange Commission (SEC) and are available on the SEC's website at www.sec.gov. In addition, the forward-looking statements included in this presentation represent INOVIO's views as of the date hereof. INOVIO anticipates that subsequent events and developments may cause its views to change. However, while INOVIO may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing INOVIO's views as of any date subsequent to the date of this presentation. Third-party industry and market information included herein has been obtained from sources believed to be reliable, but the accuracy or completeness of such information has not been independently verified by, and should not be construed as a representation by, INOVIO. The information contained in this presentation is accurate only as of the date hereof. “INOVIO” and the INOVIO logo are trademarks and service marks of INOVIO. All other trademarks, service marks, trade names, logos and brand names identified in this presentation are the property of their respective owners. Forward Looking Statements
A Pivotal Moment for RRP Patients and INOVIO VOCERYQ™ New treatment option with broad indication for adults with RRP First product for INOVIO, major milestone for DNA medicine Reduces the need for surgery by targeting the underlying viral cause of RRP
Prescribing Information and Label Details
VOCERYQ™ Now Approved Formerly known as INO-3107 Approved to reduce the frequency of surgery in adults with RRP This indication is approved under accelerated approval based on reduction in the frequency of surgical papilloma excisions. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory study(ies).
Recurrent Respiratory Papillomatosis (RRP) Rare disease characterized by small, wart-like growths (papillomas) in the respiratory tract Repeated surgery is standard of care – every surgery entails significant risk and cost Potential for irreversible damage to vocal cords Impact on quality of life, financial burden VOCERYQTM is designed to address primary patient concern: reducing need for surgery Designed to generate an antigen-specific T-cell response against HPV-6 and -11, targeting underlying cause of RRP Image Source: National Institute on Deafness and Other Communication Disorders; accessed July 27, 2022; Photographs courtesy Aaron Friedman MD, University of Cincinnati College of Medicine
Multi-Center Clinical Study at 8 Clinical Sites 4 Doses of INO-3107 Patients Enrolled N=32 Completed Study Enrollment criteria: Patients who required at least two surgical interventions in the past year for the removal of HPV-6/11-related papilloma(s) Study design: surgeries - up to 14 days before first dose, patients had RRP tissue surgically removed. No scoping and surgery required during the dosing window. Secondary endpoint: efficacy - Change in number of surgical interventions pre- vs. post-treatment initiation Primary Endpoint: Safety of INO-3107 Limited symptom assessment N=32 RRP-002 DURABILITY EXTENSION / FOLLOW-UP RRP-001 PHASE 1/2 OPEN-LABEL STUDY Patient population: Intent-to-treat (ITT) - all patients (32) Extension study: Retrospective assessment of treatment effect up to 3-years after initial dose of INO-3107 Four patients were lost to follow-up (n=28) Two refused consent, two not able to be contacted Median follow up ~1025 days, or 2.8 years New long-term efficacy data analysis published in The Laryngoscope Consented to Follow Up N=28 Median Follow Up Completed Follow Up N=4 Lost to Follow Up Baseline: DAY 0 52 WEEKS 104 WEEKS 156 WEEKS Day 0. Weeks 3, 6, 9 Morrow, M.P., Gillespie, E., Sylvester, A. et al. DNA immunotherapy for recurrent respiratory papillomatosis (RRP): phase 1/2 study assessing efficacy, safety, and immunogenicity of INO-3107. Nat Commun 16, 1518 (2025). https://doi.org/10.1038/s41467-025-56729-6 Amin MR, Belafsky PC, Best SR, Friedman AD, Klein AM, Lott DG, Mau T, Paniello RC, Pransky SM, Saba NF, Welsh C, Slog SA, Gillespie E, Dallas M, Morrow MP, Skolnik JM. DNA Immunotherapy (INO-3107) Results in Long-Term Surgery Reduction in RRP. Laryngoscope. 2025 Nov;135(11):4287-4295. doi: 10.1002/lary.32416. Epub 2025 Aug 9. PMID: 40781903; PMCID: PMC12645365. Amin MR, Belafsky PC, Best SR, Friedman AD, Klein AM, Lott DG, Mau T, Paniello RC, Pransky SM, Saba NF, Welsh C, Slog SA, Gillespie E, Dallas M, Morrow MP, Skolnik JM. DNA Immunotherapy (INO-3107) Long-Term Efficacy Supported by Enhanced Immunogenicity in HPV-6/11 RRP. Laryngoscope. 2026 Oct; https://doi.org/10.1002/lary.71016.
DOSING Week 3 6 9 Week 61 (≥3 surgeries in the 12 months prior to treatment) Analysis ends Efficacy Endpoint for Approval Based on Reduction in Surgery in 12 Months Following Dosing Completion *Includes data from weeks 9-52 from RRP-001 and from weeks 52-61 from RRP-002 0 Efficacy Analysis Period*: Weeks 9-61 (N=26) 4 doses total No surgeries required during dosing window per protocol 4.5 Median number of surgeries before treatment 27% Had no surgeries in the year after treatment with VOCERYQTM
Patient-Centric Treatment Regimen Flexibility in the administration location, including doctor’s office Does not require scoping and surgical removal of visible papilloma during dosing window Straightforward storage, requiring only standard refrigeration with a 3-year shelf life
Simple Administration with CELLECTRA® Prepare Device & Patient Deliver VOCERYQ™ Immune Response Activated VOCERYQ™ enables cell to produce a targeted immune response against HPV-6 and HPV-11 CELLECTRA® injects VOCERYQ™, then provides short electrical pulses to briefly create reversible pores in the cell membrane to allow VOCERYQ to enter muscle cells Select injection site in the thickest part of the deltoid muscle in the upper arm
Key Safety Results - Most Adverse Reactions Grade 1 or 2 Adverse Reactions RRP (N=32) n (%) Injection site reaction 11 (34%) Headache 6 (19%) Fatigue 5 (16%) Hypertension 4 (13%) Nausea 2 (6%) Dizziness 2 (6%) Other clinically significant adverse reactions occurring in <5% of patients included localized edema (3%), malaise (3%), lethargy (3%), flank pain (3%), jaw pain (3%), procedural anxiety (3%), flushing (3%), neutropenia (3%), cholecystitis (3%) and myalgia (3%). Adverse Reactions Occurring in > 5% of Patients in Study RRP-001 (N=32)
FDA Alignment on Future Confirmatory Study Proposed protocol design due to FDA by end of 2026; expected to be finalized by mid-2027 Current general protocol design components: 50+ adult and pediatric patients with RRP who had 3+ surgeries in 12 months prior to treatment with VOCERYQTM Evaluate number of surgical interventions required over at least 3 years following completion of treatment Comparison to an appropriate external control group or scientifically justified threshold Potential to explore continued treatment in patients without sustained complete response
Commercial Launch Plans
Large Addressable Patient Population with High Unmet Need 25,000+ prevalent population of patients with RRP based on ongoing claims data analysis A significant market opportunity Immunotherapy, including VOCERYQTM, is recommended as first-line therapy for RRP* VOCERYQTM has the potential to become the preferred first line treatment for RRP Based on compelling efficacy, a favorable tolerability profile and a patient centric treatment regimen * Best SR, Friedman AD, Rosen CA, Sataloff RT, Matrka LA, Sims HS, Rosow DE, Saba NF, Lott DG, Klein AM, Mau T, Amin MR, Wikenheiser-Brokamp KA, Norberg SM, McClellan K, Young GD, Allen CT; Recurrent Respiratory Papillomatosis Foundation. Recurrent Respiratory Papillomatosis Foundation Position Statement on the Management of Adults With RRP. Laryngoscope. 2026 Sep;136 Suppl 4(Suppl 4):S7-S17. doi: 10.1002/lary.70379. Epub 2026 Jan 16. PMID: 41543033; PMCID: PMC13460614.
Patient Journey – Every Surgery Matters VOCERYQ™ can reduce the frequency of surgery for adults with RRP KOL recommendation: start immunotherapy as soon as possible* Decision to treat with VOCERYQ™ Patient undergoes initial papilloma removal 4 doses over 9 weeks (no scoping or surgery required during dosing) Diagnosis (surgery and/or biopsy) *Best SR, Friedman AD, Rosen CA, Sataloff RT, Matrka LA, Sims HS, Rosow DE, Saba NF, Lott DG, Klein AM, Mau T, Amin MR, Wikenheiser-Brokamp KA, Norberg SM, McClellan K, Young GD, Allen CT; Recurrent Respiratory Papillomatosis Foundation. Recurrent Respiratory Papillomatosis Foundation Position Statement on the Management of Adults With RRP. Laryngoscope. 2026 Sep;136 Suppl 4(Suppl 4):S7-S17. doi: 10.1002/lary.70379. Epub 2026 Jan 16. PMID: 41543033; PMCID: PMC13460614.
Key Priorities for a Successful Launch Establish broad access Policies in place for insurers that cover 80% of patients within 9 months of approval Drive awareness & adoption Engage targeted laryngologists and staff to educate on VOCERYQ™ and drive adoption Provide seamless patient & customer support Through the VOCERYQ™ Support Program make access to treatment as simple as possible
Targeting and Field Deployment Driving rapid awareness, adoption and patient access Highly concentrated market* Field footprint** will cover ~90% of RRP patient potential 20 territories managed by experienced Key Account Managers (KAMs) Additional customer support by reimbursement specialists and dedicated payor support capabilities ~400 Laryngologists treat the vast majority of RRP patients ~80% of patients receive care in large IDN / academic institutions (vast majority are treated in ~100 accounts) ~20% of patients receive care in community hospitals and private group practices **Plan to leverage highly experienced field teams through our field deployment partner, Syneos Health *Based on INOVIO internal claims analysis using KOMODO and Purple Lab syndicated data
Foundations for Long-term Commercial Success Manufacturing network with current inventory and capacity expected to support launch at least through 2027 VOCERYQ™ available to order and ship & Support Program enabled in ~60 days Full field team deployment expected in the first quarter of 2027 Potential for commercial success Strength of clinical data Broad adult indication Significant unmet need Concentrated prescriber base Established infrastructure to enable a successful launch
VOCERYQ™ and Platform Potential
VOCERYQTM Program Expansion Additional treatment strategies Expansion in international markets
Advancing Our Pipeline Strategy NEAR TERM Commercialization of VOCERYQTM MID TERM Advancing Diversified Clinical Pipeline Innovating NextGen DNA Medicines NEXT GEN
Delivering on the Promise of DNA Medicine Approval of first product VOCERYQTM and transition to commercial stage company Multiple pipeline value drivers beyond VOCERYQTM Landmark moment for INOVIO and DNA medicine platform Near-term catalysts: launch and revenue generation Compelling efficacy, tolerability & patient-centric treatment regimen = potential to become preferred first-line treatment option
Q&A
Thank you. Investors: Peter Vozzo Peter.Vozzo@icrhealthcare.com Media: Josephine Galatioto inoviopr@icrhealthcare.com