Inovio Pharmaceuticals Inc.
11/10/2026 | Press release | Distributed by Public on 11/10/2026 15:02
Quarterly Report for Quarter Ending SEPTEMBER 30, 2026 (Form 10-Q)
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
This Quarterly Report contains forward-looking statements, as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements relate to future events or our future financial performance. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential" or "continue," the negative of such terms or other comparable terminology. These statements are only predictions. Actual events or results may differ materially.
Although we believe that the expectations reflected in the forward-looking statements are reasonable based on our current expectations and projections, we cannot guarantee future results, levels of activity, performance or achievements. Moreover, neither we, nor any other person, assume responsibility for the accuracy and completeness of the forward-looking statements. We are under no obligation to update any of the forward-looking statements after the filing of this Quarterly Report to conform such statements to actual results or to changes in our expectations.
The following discussion of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and the related notes and other financial information appearing elsewhere in this Quarterly Report and our audited consolidated financial statements and related notes for the year ended December 31, 2025 included in our Annual Report on Form 10-K, or 2025 Annual Report, filed with the U.S. Securities and Exchange Commission, or SEC, on March 12, 2026. Readers are also urged to carefully review and consider the various disclosures made by us that attempt to advise interested parties of the factors that affect our business, including without limitation the disclosures made in Item 1A of Part II of this Quarterly Report under the captions "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations," and the disclosures made in our 2025 Annual Report under the caption "Risk Factors" and in our audited consolidated financial statements and related notes.
Risk factors that could cause actual results to differ from those contained in the forward-looking statements include but are not limited to: our history of losses; our ability to successfully commercialize VOCERYQ and maintain its regulatory approval; uncertainties inherent in clinical trials and product development programs, including but not limited to the fact that preclinical and clinical results may not be indicative of results achievable in other trials or for other indications, that the studies or trials may not be successful or achieve desired results, that preclinical studies and clinical trials may not commence, have sufficient enrollment or be completed in the time periods anticipated, that results from one study may not necessarily be reflected or supported by the results of other similar studies, that results from an animal study may not be indicative of results achievable in human studies, that clinical testing is expensive and can take many years to complete, that the outcome of any clinical trial is uncertain and failure can occur at any time during the clinical trial process, and that our proprietary device technology and DNA medicine candidates may fail to show the desired safety and efficacy traits in clinical trials; the availability of funding; the ability to manufacture VOCERYQ and our DNA medicine candidates; the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or our collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that we and our collaborators commercialize or hope to develop; our ability to receive development, regulatory and commercialization event-based payments under our collaborative agreements; whether our proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity; and the impact of government healthcare laws and proposals.
INOVIO, CELLECTRA, the INOVIO logo, and our other trademarks or service marks appearing in this Quarterly Report are our property. Solely for convenience, the trademarks and trade names in this report are referred to without the ® and TM symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. Products or service names of other companies mentioned in this Quarterly Report may be trademarks, trade names or service marks of their respective owners.
References herein to "we," "our," "us," "INOVIO" or the "Company" refer to INOVIO Pharmaceuticals, Inc. and its consolidated subsidiaries. References herein to "DNA medicines" refer to VOCERYQ and our product candidates in development for diseases associated with human papillomavirus (HPV), cancer, and infectious diseases.
Overview
We are a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer and infectious diseases. Our platform harnesses the power of in vivo protein production, featuring optimized design and delivery of DNA medicines that teach the body to manufacture its own disease-fighting tools.
We use proprietary technology to design DNA plasmids, which are small circular DNA molecules that work like software the body's cells can download to produce specific proteins to target and fight disease. Our proprietary investigational and
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medical CELLECTRA® delivery devices are designed to deliver the DNA medicines into the body's cells for optimal effect, without the use of chemical adjuvants, lipid nanoparticles or viral vectors.
Our first commercial-stage product is VOCERYQ (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd), formerly referred to as INO-3107, a plasmid DNA-based immunotherapy delivered by our CELLECTRA 5PSP medical device. The U.S. Food and Drug Administration, or FDA, approved VOCERYQ under its accelerated approval program to reduce the frequency of surgery in adults with recurrent respiratory papillomatosis, or RRP, a chronic, rare and debilitating disease characterized by the growth of small tumors, or papillomas, in the respiratory tract primarily caused by HPV-6 and/or HPV-11 genotypes. Based on our ongoing analysis of claims data, we believe there currently is a prevalent population of at least 25,000 patients with RRP in the United States. Although mostly benign, the papillomas caused by RRP can extend into the lungs, carrying a higher risk of respiratory complications and malignant transformation. The current standard of care for RRP is repeated invasive surgery, which comes with its own significant risks and costs to patients. VOCERYQ is designed to elicit an antigen-specific T cell response against both HPV-6 and HPV-11 proteins. These targeted T cells seek out and kill HPV-6 and HPV-11 infected cells, with the aim of reducing the need for surgery. Following a standard-of-care surgical debulking of visible papilloma prior to the initial administration of VOCERYQ, no additional scoping or surgical intervention is required as part of the nine-week dosing regimen.
Recent Developments
On October 30, 2026, the FDA approved VOCERYQ under its accelerated approval program to reduce the frequency of surgery in adults with RRP. VOCERYQ was approved in combination with CELLECTRA. The approval was supported by data from our RRP-001 trial evaluating VOCERYQ in 32 adult patients with RRP who had two or more surgeries in the year prior to treatment, of whom 26 patients required three or more surgeries for papilloma excision in the 12 months prior to treatment and were included in the efficacy evaluation. 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. VOCERYQ was found to be well tolerated, with the most common adverse reactions, each occurring in 5% or more of patients, including injection site reactions, headache, fatigue, hypertension, nausea and dizziness. The continued approval of VOCERYQ under accelerated approval for this indication may be contingent upon verification and description of clinical benefit in one or more confirmatory studies. We have agreed with the FDA that a confirmatory study should enroll at least 50 adult and pediatric patients with RRP requiring three or more surgical interventions, in the 12 months prior to treatment with VOCERYQ. Subject to further regulatory feedback, we expect a confirmatory study to evaluate the number of surgical interventions required over at least three years, following completion of treatment, and compare this to an appropriate external control group or scientifically justified threshold. We may also explore continued treatment in patients without a sustained complete response as part of a confirmatory study. We expect to submit a draft protocol for this confirmatory study by the end of 2026 as required by the FDA, with the goal of aligning on a final protocol by mid-2027.
Following FDA approval, we are proceeding with commercial launch activities for VOCERYQ. We have engaged Syneos Health to support the recruitment and deployment of our medical and commercial field teams. We have also engaged or identified key commercial partners, including a third-party logistics provider, Agency of Record, specialty distributor, specialty pharmacy, and patient HUB. We expect to make VOCERYQ available to order and ship in approximately 60 days from approval and anticipate full field deployment during the first quarter of 2027. We also expect insurers that cover approximately 80% of patients in the US to have policies in place for coverage within nine months of approval, based on our Payer research to date.
In addition to our U.S. regulatory activities, we plan to submit an application for conditional marketing authorization for VOCERYQ in Europe before the end of 2026.
As a rare disease, RRP is a concentrated market. An estimated 400 laryngologists treat the vast majority of RRP patients. About 80% of patients with RRP receive care in large Integrated Delivery Networks or academic institutions. There are about 100 of these institutions treating the majority of patients in this segment. The remaining 20% of RRP patients receive care in community hospitals and private group practices. Our field teams will aim to engage both of these customer segments, and overall, our field footprint will aim to cover about 90% of RRP patient potential. Our field organization is expected to include 20 territories with Key Account Managers, reimbursement specialists, and dedicated payer support capabilities deployed across those territories. We believe we have established the infrastructure needed to support a successful U.S. launch. We expect our device and plasmid manufacturing network to be prepared to meet anticipated demand, with current inventory and capacity available to support the first year of launch through at least 2027. We anticipate VOCERYQ to be priced at approximately $115,000 per dose, or $460,000 for the complete four-dose treatment series, which is consistent with the previously approved immunotherapy to treat adults with RRP.
Our Product Candidates in Development
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While the majority of our resources are focused on VOCERYQ, we continue to advance other pipeline candidates through partnerships and other strategic relationships. Toward this goal, in early 2026 we announced a collaboration with Akeso Inc. to evaluate INO-5412 in combination with their novel PD-1/CTLA-4 checkpoint inhibitor as a potential treatment for glioblastoma, or GBM, one of the most complex, deadly, and treatment-resistant cancers, in a Phase 2 adaptive platform trial sponsored by the Dana-Farber Cancer Institute. INO-5412 is an investigational DNA medicine that combines INO-5401 and INO-9012 into a single vial as a potentially powerful cancer immunotherapy particularly when given in combination with checkpoint inhibitors. INO-5401 plus INO-9012 has been previously investigated as a potential therapeutic treatment targeting a number of cancers, including GBM and cancers exhibiting BRCA1 and BRCA2 mutations. Data from an ongoing Phase 2 trial in newly diagnosed GBM patients, highlighted in a 2022 oral presentation at the American Society of Clinical Oncology, demonstrated that INO-5401 plus INO-9012 in combination with a PD-1 checkpoint inhibitor elicited robust immune responses that potentially correlated with enhanced survival. INO-5401 encodes for our Synthetic Consensus antigens of hTERT, WT1, and PSMA, which are antigens the National Cancer Institute has highlighted as important targets and designated as high priorities for cancer immunotherapy development. These three antigens have been reported to be over-expressed and often mutated in a variety of human cancers, including GBM. INO-9012 encodes for IL-12, which is a T cell immune activator.
Other products in our development pipeline include INO-3112, a DNA immunotherapy candidate targeting HPV-16/-18 combined with a DNA plasmid encoding for human IL-12 as an immune activator, for the treatment of oropharyngeal squamous cell carcinoma, or OPSCC, a type of head and neck cancer commonly known as throat cancer. We entered into a clinical collaboration and supply agreement with Coherus BioSciences, Inc., or Coherus, to evaluate the combination of INO-3112 and LOQTORZI (toripalimab-tpzi) in a clinical trial for patients with locoregionally advanced, high-risk, HPV-16/-18 positive OPSCC. Under the terms of the supply agreement, Coherus will provide LOQTORZI for a planned Phase 3 clinical trial. We have also gained alignment with FDA on the design of the planned Phase 3 trial in the United States and received initial feedback from European regulatory authorities on the proposed design of the trial in Europe.
Other pipeline candidates include those targeting HPV-related anal dysplasia; cancers associated with certain gene mutations; and a potential vaccine booster to protect against the Ebola virus. We are also working to identify partnership opportunities to advance our DNA-Encoded Protein (DPROT) and DNA-Encoded Monoclonal Antibody technology (DMAbTM), with a focus on developing additional DPROT indications in the rare disease space, including Hemophilia A, Fabry Disease and Hypophosphatasia (HPP). This technology has shown great potential across multiple disease targets through the production of monoclonal antibodies within the body.
We previously conducted clinical trials of a DNA immunotherapy candidate for the treatment of HPV-related cervical high-grade squamous intraepithelial lesions, but announced in 2023 that we were ceasing development for this indication in the United States. However, in May 2026, our collaborator ApolloBio Corporation, or ApolloBio, announced positive topline results from their ongoing Phase 3 clinical trial of this product candidate in China. ApolloBio continues to advance the program and plans to use these results to seek regulatory approval for the product candidate and, if approved, potentially commercialize it in that jurisdiction.
Besides VOCERYQ, all of our DNA medicine candidates are in the research and development phase. We have not generated any revenues from the sale of any products, and we do not expect to generate any material revenues until we successfully commercialize VOCERYQ. We earn revenue from license fees and milestone revenue and collaborative research and development agreements and contracts. Our DNA medicine candidates will require significant additional research and development efforts, including extensive preclinical and clinical testing. All DNA medicine candidates that we advance to clinical testing will require regulatory approval prior to commercial use, and will require significant funding for commercialization. We may not be successful in our research and development efforts, and we may never generate sufficient product revenue to be profitable.
Our partners and collaborators include Akeso, Alliance Medical Products, Inc. (dba Siegried Irvine), ApolloBio, AstraZeneca, Coherus, Dana-Farber Cancer Institute, Defense Advanced Research Projects Agency (DARPA), HIV Vaccines Trial Network, Kaneka Eurogentec, National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Plumbline Life Sciences, Regeneron Pharmaceuticals, Richter BioLogics, the University of Pennsylvania and The Wistar Institute.
As of September 30, 2026, we had an accumulated deficit of $1.9 billion. We expect to continue to incur substantial operating losses in the future due to our commitment to our research and development programs, the funding of preclinical studies, clinical trials and regulatory activities and the costs of selling, general and administrative activities.
Critical Accounting Policies and Estimates
There have been no significant changes to our critical accounting estimates since December 31, 2025. For a description of our critical accounting estimates and significant judgments used in the preparation of our condensed consolidated financial statements, refer to Note 3 to our Condensed Consolidated Financial Statements included in this Quarterly Report, as well as
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Inovio Pharmaceuticals Inc. published this content on November 10, 2026, and is solely responsible for the information contained herein. Distributed via EDGAR on November 10, 2026 at 21:03 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]