Good morning, ladies and gentlemen, and welcome to the VOCERYQ FDA Accelerated Approval INOVIO investor conference call. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a Q&A session. If at any time during this call you require immediate assistance, please press star 0 for the operator. This call is being recorded on Monday, November 2, 2026. I would now like to turn the conference call over to Jennie Willson. 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 Q&A 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 HPV-6 and HPV-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 HPV-6 and HPV-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 RRP-001, 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- 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 RRP-002, 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 3+ 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.
CELLECTRA is a handheld injection device that is designed to be easy to use, and any healthcare provider can be trained to use it. After preparing the device and placing it against the patient's arm, a single press of the handset button enables CELLECTRA to inject VOCERYQ and then provide short electrical pulses to briefly create pores in the cell membrane to allow the immunotherapy to enter the muscle cells. This process has been shown in clinical studies to be well tolerated and takes approximately 10 seconds. in terms of safety, VOCERYQ was shown in the clinical study to be well tolerated, with study participants experiencing mostly low-grade treatment-emergent adverse events such as injection site pain and fatigue. This slide lists adverse reactions occurring in greater than or equal to 5% of patients as described in the prescribing information. Patients completed the study.
For this approval, the safety data were further supported by data from VGX-3100, a HPV-16 and HPV-18 related disease program, which included over 1,100 administrations. One additional point on safety. Every individual surgery conveys risk to an RRP patient, including irreversible vocal cord damage. Reducing the need for surgery, either as part of or as a result of treatment, is an important consideration for patients. Finally, I'd like to share a brief overview of our future confirmatory study. As we have received an Accelerated Approval, continued approval for this indication may be contingent on verification and description of clinical benefit in a confirmatory study. We expect to submit a draft protocol for this study before year-end and have until mid-next year to align on the final protocol with the agency.
We have agreed with the agency that the 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. We expect the 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 the study. I will now turn it over to Steve Egge, our Chief Commercial Officer, for an overview of our commercial launch plans. Steve?
Thank you, Mike. We're excited to launch VOCERYQ and are focused on ensuring eligible patients can access treatment as quickly and as efficiently as possible. Before we dig into our launch strategy, let's put the RRP market in perspective. There's limited recent epidemiology data for RRP. Based on our ongoing analysis of claims data, we believe there's a prevalent population of at least 25,000 patients with RRP in the U.S., with additional patients diagnosed each year. Surgery has been the standard of care for decades. However, recently, Key Opinion Leaders in the RRP Foundation stated in a position paper published in The Laryngoscope that the goal is to reduce or eliminate the need for repeated surgeries to avoid vocal cord damage and recommends that immunotherapy should be considered the first-line treatment for RRP.
To date, only a small fraction of the prevalent population of patients have been treated with immunotherapy, indicating that there is significant market opportunity for VOCERYQ. Based on its compelling efficacy, a favorable tolerability profile, and a patient-centric treatment regimen, we believe VOCERYQ has the potential to become the preferred first-line treatment for RRP. This is what we're focused on and most excited about. When we think about the patient journey, The Laryngoscope position paper recommends that immunotherapy be considered as early as possible in the patient journey. That means that once a diagnosis has been established through biopsy or surgery, physicians and patients can discuss treatment with VOCERYQ. Once the physician and patient decide to proceed, the patient would undergo initial papilloma removal and then complete a four-dose treatment series over nine weeks.
Importantly, in the label for VOCERYQ, there's no requirement for scoping and surgery to remove visible papillomas during the dosing window, and the importance of this distinguishing characteristic is noted in the position paper. This patient-centric dosing for VOCERYQ is important, as every surgery matters to patients, and every surgery carries both risks and costs to the patient. Further, by intervening earlier in the disease, VOCERYQ has the potential to reduce the need for repeated surgical intervention and alleviate the significant burden that comes with each surgery. Looking ahead, I'd like to outline the three key priorities essential for a successful launch. First, we're working to ensure patients can access VOCERYQ as quickly as possible. Payers recognize the burden of recurrent surgery in RRP and the need for additional treatment options.
We expect insurers that cover approximately 80% of patients in the U.S. to have policies in place for coverage within nine months of approval, based on our payer research to date. In parallel, we plan to apply for a permanent J- code to help simplify reimbursement, support medical exception pathways, and work closely with integrated delivery networks, or IDNs, and hospital systems to initiate product availability through pharmacy and therapeutics committee reviews. These committees decide which medications are added to the IDN or hospital's official drug list or formulary. Second, our commercial field teams will engage targeted laryngologists and associated staff to educate on VOCERYQ and drive awareness and adoption. The focus will be on communicating the unique value proposition of VOCERYQ, including its compelling efficacy, favorable tolerability, and a patient-centric treatment regimen that does not require scoping and surgeries during dosing.
To support adoption, we plan to provide CELLECTRA devices coupled with live training and implementation support to ensure accounts can begin treating patients efficiently. Third, we aim to make the treatment process as seamless as possible for both patients and physicians. We're launching the VOCERYQ support program to provide a single point of contact, and it's designed to provide support around product ordering, product benefit, patient benefit investigation and verification, copay support, and our patient assistance program. Our goal is to minimize the administrative burden and make access to treatment simple for healthcare providers and patients. We aim to have the VOCERYQ support program in place once product is available. To drive awareness and adoption, our strategy is highly focused and designed to efficiently reach the physicians who treat the majority of patients with RRP.
To do this, we plan to leverage highly experienced field teams through our field deployment partner, Syneos Health. As a rare disease, RRP is a concentrated market. About 400 laryngologists treat the vast majority of RRP patients. About 80% of patients with RRP receive care in large IDNs or academic institutions. There are about 100 of these institutions treating the majority of patients in this important segment. The remaining 20% of RRP patients receive care in community hospitals and private group practices. Our field teams will engage both of these important 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 these territories. Our medical team has also commenced deployment of Medical Science Liaisons to engage with KOLs in the field.
With recruitment and deployment already underway, we believe this targeted model positions us to drive rapid awareness, adoption, and patient access. We believe we've 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 to support the first year of launch through at least 2027. We currently expect VOCERYQ will be available to order and ship in approximately 60 days, and expect full field deployment during the first quarter of 2027. We anticipate VOCERYQ to be priced at approximately $115,000 a dose, or $460,000 for the complete four-dose series. This is consistent with a previously approved immunotherapy to treat adults with RRP.
Based on the combination of strong clinical data and broad adult indication, the significant unmet need and concentrated prescriber base, we're confident in the potential for a successful launch and longer-term commercial success. I'll now turn the call back to Jackie to discuss how we plan to build on this approval and continue advancing our DNA medicines pipeline.
Thanks, Steve. The approval of VOCERYQ is a pivotal milestone for INOVIO that we believe offers many exciting opportunities to drive progress across the INOVIO pipeline. For VOCERYQ, we see potential to expand into additional indications and geographies. In addition to pediatrics, we plan to explore additional treatment strategies in the future, including investigating continued treatment options. One of the strengths of our platform is the ability to provide additional doses to continue to amplify the targeted T-cell response. We're also evaluating additional markets, including the E.U., U.K., and other international markets. The FDA's Accelerated Approval of VOCERYQ validates our DNA medicine platform and paves the way for progress with other promising candidates in the pipeline. Together with our partners, we'll be advancing our later-stage clinical candidates, and we are also seeking new partnerships to advance our next-generation DPROT candidates in rare disease.
We believe these investigational protein replacement therapies have the potential to transform the treatment paradigm for genetic diseases like hemophilia A, Fabry disease, and hypophosphatasia. With the approval of VOCERYQ as our first product, we have become a commercial-stage company. This is a landmark moment for INOVIO and our DNA medicine platform, and we are incredibly excited about the potential to help the many RRP patients who are searching for relief from the relentless cycle of surgery. VOCERYQ offers compelling efficacy and tolerability within a patient-centric treatment regimen, and we see potential for it to become the preferred first-line treatment option for RRP. We are excited about the significant market opportunity with a large addressable patient population, which is the focus of our strategic launch.
We see multiple pipeline value drivers ahead, and we look forward to providing updates on our launch progress and delivering on the promise of our DNA medicine platform. I would now like to pause to open up the call to answer any questions you might have. Operator?
Thank you. Ladies and gentlemen, we will now begin the Q&A session. Should you have a question, please press the star followed by the one on a touchtone phone. Should you wish to cancel your request, please press the star followed by the two. If you are using a speakerphone, please lift the handset before pressing any keys. Once again, that is star one should you wish to ask a question. Your first question is from Roger Song from Jefferies. Your line is now open.
Great. Huge congrats for this landmark approval for RRP patients. Thank you for taking our question. Quite a few questions from us, if I may. First of all, in terms of the overall addressable market, given this label seems to be more focused on the patient with three or more surgery in the prior year, how should we think about that population in the overall prevalence? I think you cited 25,000. How about the incidence as well? So how should we think about the overall patient number here? Number two is your label CR rate is 27% versus other RRP newly approved drug is 50%+. Understanding you have a different way to measure the CR in the first couple months during the dosing window. How kind of receptive from the physician community comparing those two number, given you are aiming for the first-line treatment?
Since the label is not including the second year or third year CR rate, how would you leverage that data to strengthen the position of the launch? Maybe just last one quickly on the commercial, just curious about your overall strategy on the financing, and also you have the partnership, and with this profile, how strongly you think about the ramp going to look like? Thank you.
Morning, Roger. All great questions. Let's start off with the first one in terms of the addressable market. I think it's very important to note that our label is for reduction in surgery in all adults with RRP. It's really a very broad adult indication. The FDA's efficacy analysis focused on the 3+ population, but in our trial, I think it's important to note that we enrolled patients who'd had two or more surgeries in the year prior. We talked about on today's call the 25,000 patients from our ongoing claims data analysis. We believe that there's this large prevalent population of RRP patients who are seeking alternatives to surgery, and to date, only a very small fraction of those patients have received immunotherapy. We think the vast majority of the market is still available to VOCERYQ.
I think another really important point to bear in mind is we mentioned in today's call regarding the position paper. The position paper recommends immunotherapy as soon as possible after diagnosis, because every surgery comes with the risk of potential irreversible damage to the vocal cords or the airways. It's really important to start treatment quickly. To summarize, we have a broad indication for all adult RRP patients. We believe there's a large addressable patient population, most of whom haven't received immunotherapy to date. Only a very small number have. The KOL community is extremely supportive of starting immunotherapy as soon as possible after diagnosis. We think this really presents a very compelling market opportunity. In terms of moving on to your second question in terms of the label. For our label, FDA focused their efficacy analysis on the 3+ population.
I think what's very clear is that the two products, the study designs for the two products were very different. For VOCERYQ, as you can see in our label, we did not require surgeries to maintain minimal residual disease at doses three and four. We designed the trial this way because every surgery matters to patients. I think broadly, doctors, and certainly the KOLs and physicians that we've spoken to, understand this difference and how important it is. This difference is also called out in the position paper as well. Mike, would you like to add to this?
Yeah, I think I was reading the press release from the RRP Foundation, and I think they framed it very nicely at sort of what questions the patient should be having with the physician. They said, "You should ask about the treatment administration. You should ask about the tolerability profile. You should ask about expected efficacy." When you look at our efficacy profile, clearly we didn't just measure complete response. We have very broadly published clinical data and been active at conferences. We believe there is good knowledge of what VOCERYQ actually brings to patients from an efficacy standpoint.
If I can just add here, for our RRP-001 trial, we worked with eight of the leading clinical centers in RRP. For our confirmatory trial, we're due to be working with about 20 of these leading sites as well. Amongst the KOL community, I think there's a really good understanding of the potential that VOCERYQ offers. Very good awareness already out there in the community. Moving on to your third question around the second-year data. Because this was an Accelerated Approval, FDA only looked at the first-year data, and the novel endpoint that they chose for Accelerated Approval was the complete response rate in that first 12 months. Obviously, we published the full dataset. That's well-known by the community, and I think we're going to continue publishing data, our clinical data, and further analysis on our clinical data as they become available.
An indication of that is the publication just last Friday of a further analysis of our long-term efficacy data and the immunology that supports it. Moving on then to overall strategy with financing and the ramp-up of our launch. We're really excited about bringing VOCERYQ to patients. We think there's high unmet need, we think there's pent-up demand, and we believe there's a large addressable patient population. Our current finances fund us through launch and into first quarter of next year, 2027. Clearly, we're going to need to raise additional funds to fully fund the launch, and we're evaluating potential routes to do that. Hopefully, we've addressed your questions.
Thank you.
Thank you. Your next question is from Yi Chen from H.C. Wainwright. Your line is open.
Congratulations, and thank you for taking my questions. Is the main reason that the FDA granted Accelerated Approval rather than traditional approval the limitation of the data available to one year, or are there other reasons for Accelerated Approval instead of traditional approval? Also, what exactly must the confirmatory trial demonstrate to convert VOCERYQ to traditional approval? Thank you.
Yi, great questions. I will take the first one, and then I will ask Mike to take the second one. I think it is really important to note that by recognizing, by awarding Accelerated Approval, FDA recognized the continuing unmet need in the RRP population and that VOCERYQ could provide meaningful therapeutic benefit. We submitted our BLA under Accelerated Approval based on the previous discussions with FDA, and I am delighted that we have successfully achieved it. We believe that FDA focused on the first year of data for Accelerated Approval because that is what they had previously guided as the basis of the grounds for Accelerated Approval. So we were pleased to see the very broad label that we received from FDA of all adults with RRP for reduction of surgery, because we believe reduction in surgery is what really matters to patients. Mike, do you want to comment on the confirmatory study?
Yeah, certainly. I mean, we have agreed with the agency that the study should enroll at least 50 adult and pediatric patients, and we should be following them for clinical efficacy over three years. Beyond that, at the moment, we have not really started our discussions of what that study is going to look like. You heard me say on the call, we have to put our initial protocol in by the end of the year, but then we actually have till June of next year to align on what that study is actually going to look like. So hopefully, I will be able to provide more details in the coming months.
And just a quick follow-up. Are there any differences in complete responses rates between patient subgroups who had different numbers of surgical procedures in the prior 12 months, such as two, three, or four or more surgeries?
If you look at the population of three or more in our study, there were 26 patients, which actually had a median number of surgeries coming into the study of 4.5. So we actually had a broad range, and clearly, these patients had severe disease with a median number of surgeries of 4.5. We did not see any particular difference based on the number of surgeries that they had had prior to treatment with VOCERYQ.
Yeah. Also, importantly, we didn't see any difference regardless of whether it was HPV-6 and HPV-11 subtype.
All right. Thank you.
Yeah.
Thank you. Your next question is from Ted Tenthoff from Piper Sandler. Your line is open.
Great. Thank you. Two quick questions, if I may. Firstly, just back to the patient number of around 25,000. What percentage of those are adults versus pediatric? Do you think the confirmatory study trial alone would be enough to expand the label into children? Then I have a follow-up question on Syneos and how that works.
Nice to hear you, Ted. Steve, I will ask you to take the 25,000 question.
Yeah, sure. Hey, Ted. Great question. The 25,000 that we see in the claims data are adults, so we believe the prevalent population of adults with RRP is 25,000.
Gotcha.
Mike, do you want to comment on the Sure.
Yeah. So, with respect to moving into having a pediatric license, we've always thought that our approach to pediatrics was going to be somewhat of a stepwise approach. So, we will probably likely include adolescents into the original study, and then progress from there. But hopefully, in the coming years, we clearly would like a pediatric indication, as there's still a clinical need in that population.
That's great. Then, quick question on Syneos. I guess this one goes back to Steve. How many reps do they plan to field? Then I guess for Peter, how does revenue recognition work? Do you recognize the revenues, and how much are you paying to Syneos? Thank you.
Yeah. So, hey, Ted. So with respect to Syneos, we plan to have 20 key account manager territories. So there would be 20 key account managers deployed across the U.S. Again, that footprint should cover about 90% of the RRP patient opportunity. But then these territories are also supported by MSLs as well as access and reimbursement specialists as well. Does that answer your question?
Yep, absolutely.
Okay.
Regarding revenue recognition. Oh, sorry.
Yeah. Hi, Ted. This is Peter. Yeah, so revenue recognition. Hello?
Yeah, go ahead.
Yep.
Sorry. Okay. I couldn't hear if you heard me. Yeah, revenue recognition will be pretty standard. We're working through the final details, but pretty much when the product is received at the end location is when we'll recognize the revenue.
Okay. Thank you very much.
You're welcome.
Thank you. There are no further questions at this time. Please proceed with the closing remarks.
Thank you. I would like to close today by taking a moment to once again recognize everyone that has supported the development of VOCERYQ, the first FDA-approved plasmid DNA-based immunotherapy. I would like to thank RRP patients and the RRP Foundation. Your advocacy and support has been instrumental in advancing RRP care and changing the treatment landscape for your community. Thank you also to the RRP-001 clinical investigators and to our incredible team here at INOVIO, who are deeply committed to delivering on the promise of DNA medicine. We are excited about the potential for VOCERYQ and look to the future knowing that every surgery matters, every patient matters, and every patient deserves a treatment that works for them.
Thank you. Ladies and gentlemen, the conference has now ended. Thank you all for joining. You may now disconnect your lines.