Inovio Pharmaceuticals Study result

Please go ahead. Hello, and thank you for joining us on this important day to discuss the FDA approval of VOCERYQ, the first approved product from Inovio's DNA medicine platform.

Today, you'll hear from Dr. Jackie Shea, President and Chief Executive Officer, Dr. Mike Sumner, Chief Medical Officer, and Steve Egge, Chief Commercial Officer, as we provide highlights of the approval, label, and our commercial launch plans. Following prepared remarks, we will conduct a question-and-answer segment.

Before we begin, I'd like to remind you that we'll be making certain forward-looking statements as outlined in this slide, including but not limited to our ability to obtain and maintain regulatory approvals of our product candidates, design and timing of our planned confirmatory study, the potential benefits of VOCERYQ and our belief that VOCERYQ has a positively differentiated product profile and the potential to become the preferred product by patients and their physicians, and our commercial launch plans and strategy, and our plans to expand VOCERYQ into additional indications and geographies and to advance our broader pipeline. All of these statements are based on the beliefs and expectations of management as of today. Actual events or results could differ materially.

We refer you to the documents we file from time to time with the SEC, including our latest quarterly report on Form 10-Q for the quarter ended June 30, 2026, which identify important risk factors that could cause actual. Excuse me. Which could cause actual. Excuse me for one second. Actual results to differ materially from those expressed by the company verbally, as well as statements made within last Friday's press release. This call is being webcast live, and a link can be found on our website, ir.inovio.com, and a replay will be made available shortly after this call is concluded. I will now turn the call over to Inovio's President and CEO, Dr. Jackie Shea.

Good morning, everyone. I am delighted to announce today that VOCERYQ, formerly known as INO-3107, has been approved by the FDA under the Accelerated Approval Program as a new non-surgical treatment option for adults with recurrent respiratory papillomatosis, or RRP. RRP is a rare, debilitating disease caused by the human papillomavirus, or HPV, that results in small growths in the airways and on the vocal cords called papilloma. VOCERYQ is a plasmid DNA-based immunotherapy that targets the viral root cause of RRP, and we believe it has the potential to transform the treatment paradigm for this disease by providing a patient-centric treatment option designed to deliver what we understand matters most to patients, reducing the need for surgery.

Through the development process, we heard countless stories from patients about the relentless cycle of RRP symptoms and surgeries, and the risks and impact of every single surgery on the quality of their lives. With accelerated approval and a broad adult indication to reduce the frequency of surgery, the FDA has recognized that impact and the therapeutic benefit of VOCERYQ. The approval of VOCERYQ is also a landmark moment for Inovio. As our first approved product and the first FDA-approved plasmid DNA-based immunotherapy, we believe it is an important validation of our DNA medicine platform for future development opportunities. Before we go into the specifics of the label for VOCERYQ, I'd first like to thank everyone that helped make this achievement possible, the patients, the RRP Foundation, the clinical study investigators, and my colleagues at Inovio.

I'd also like to thank the FDA for recognizing the significant unmet need in the RRP community and continuing to prioritize innovative treatments for the patients who need them most. In today's call, we'll be focused on reviewing highlights from the broad indication in adults for VOCERYQ and supporting clinical data. We'll also discuss our initial launch strategy and key commercial objectives, which are focused on serving patients and driving long-term value for all our stakeholders. I'll now ask Mike Sumner, our Chief Medical Officer, to provide an overview of the product label and prescribing information in the U.S.

Mike? Thanks, Jackie. I'd like to start by echoing Jackie's sentiments.

This is a momentous day for the RRP community and every adult patient who is searching for a therapeutic option that works for them to reduce the need for surgery. We are thrilled to announce that VOCERYQ has been approved under the Accelerated Approval Program to reduce the frequency of surgeries in adults with RRP, an indication that we believe reflects what matters most to patients. With accelerated approval, the FDA has acknowledged the significant unmet need for non-surgical treatment options for RRP and the potential therapeutic benefit that VOCERYQ can provide. To understand why the approval of VOCERYQ is so meaningful to the RRP community, it's important to appreciate the devastating nature of RRP and what patients have had to endure with surgery as the standard of care.

RRP is a rare HPV6 and 11-related disease that causes benign growths called papilloma in the airways, principally the throat and larynx. Every RRP patient faces significant risks and costs associated with both the symptoms and the repeated surgeries required to treat this disease. That includes difficulty speaking, swallowing, and breathing, missed work, school, and social events, and the physical and psychological toll of surgery itself. In severe cases, patients can have hundreds of surgeries over a lifetime, and every surgery presents a risk of permanent vocal cord or airway damage. VOCERYQ is a new type of immunotherapy designed to provide relief from the relentless cycle of surgery by addressing the underlying viral cause of RRP. VOCERYQ is a DNA medicine composed of two DNA plasmids, one encoding for the E6 and E7 proteins from HPV6 and 11, and one encoding for human IL-12 to enhance the immune response.

Once administered, VOCERYQ enables the muscle cells to produce the viral proteins specific to HPV, giving the immune system a precise target to recognize. VOCERYQ was evaluated in study RRP001, which was conducted across eight clinical sites, representing multiple top medical institutions in the field of laryngology, the specialty that treats RRP. The study included 32 adult participants, which were representative of the real-world RRP population. Study participants were adults ranging in age from 25 to 82. They had required two to eight surgeries in the year prior to treatment and included both juvenile and adult-onset RRP. Once enrolled in the study, patients had visible papilloma surgically removed before receiving their first dose of VOCERYQ. Patients then received four doses over a nine-week period. During the dosing window, no additional surgeries to remove visible papilloma were required in the protocol.

The primary efficacy endpoint was a reduction in surgery following dosing initiation. We also conducted RRP002, a retrospective study of patients who had participated in the 001 study. The full clinical dataset were published in Nature Communications and in The Laryngoscope, the top journal for the specialists who treat RRP, in 2025, with an additional analysis of our long-term efficacy just published in The Laryngoscope last Friday. The FDA's efficacy analysis evaluation for Accelerated Approval focused on the first-year treatment effect and included 26 patients who required three or more surgeries in the 12 months prior to treatment. For those 26 patients, the median number of surgeries in the 12 months prior to the first dose was 4.5. This included the surgical debulking required immediately prior to treatment. FDA's efficacy analysis commenced at the end of the dosing window at week nine.

In the following 12 months, 27% of the patients achieved complete response, as defined by not requiring any surgeries to manage their disease. Patients going from three-plus surgeries to zero surgeries following treatment would not be expected as part of the natural history of the disease. VOCERYQ offers a treatment regimen that reduces the burden on patients and physicians, potentially enabling it to become the preferred product for patients and providers. Per its label, VOCERYQ does not require scoping and surgery to remove any visible papilloma during the dosing window and is generally well tolerated. VOCERYQ also only requires standard refrigeration and has a three-year shelf life. These straightforward distribution requirements should facilitate flexibility in the administration location, including the doctor's office. VOCERYQ is administered with our innovative and proprietary CELLECTRA device, which is an integral part of the demonstrated efficacy of our plasmid DNA-based immunotherapy, enabling targeted localized delivery.