Good afternoon, ladies and gentlemen, and welcome to the Inovio Pharmaceuticals Third Quarter 2026 Financial Results Conference Call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question-and-answer 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 Tuesday, November 10, 2026. I would now like to turn the conference over to Jennie Willson. Thank you. Please go ahead.
Good afternoon, and thank you for joining the Inovio Third Quarter 2026 Financial Results Conference Call. Joining me on today's call are Dr. Jackie Shea, President and Chief Executive Officer, Dr. Mike Sumner, Chief Medical Officer, Steve Egge, Chief Commercial Officer, and Peter Kies, Chief Financial Officer. Today's call will review our corporate and financial information for the quarter ended September 30th, 2026, as well as provide a general business update. Following prepared remarks, we will conduct a question-and-answer segment.
Before we begin, I'd like to remind you that we will be making certain forward-looking statements as outlined in this slide, including but not limited to our ability to obtain and maintain regulatory approval of our product candidates, the design and timing of our planned confirmatory study, the potential benefits of VOCERYQ and its potential to become a product preferred by patients and their physicians, our commercial launch plans and strategy, including anticipated cash runway, cash burn, and timing of product revenues, and our plans to expand VOCERYQ into additional indications and geographies 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, which under the heading Risk Factors, identify important factors that could cause actual results to differ materially from those expressed verbally by the company or in this afternoon'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 afternoon, and thank you to everyone for joining. I'd like to start today's call by highlighting the recent FDA approval of VOCERYQ, formerly known as INO-3107, under the Accelerated Approval Program as a new non-surgical treatment option to reduce the frequency of surgery in adults with recurrent respiratory papillomatosis, or RRP. In the press release it issued, the FDA stated that VOCERYQ was a groundbreaking therapy and that its approval represented a meaningful scientific breakthrough by offering patients a plasmid DNA-based immunotherapy that harnesses the body's own immune system to fight the underlying cause of RRP. The Accelerated Approval for VOCERYQ and the broad indication included in its label for adults with RRP are an acknowledgment of the significant unmet need for non-surgical treatment options for RRP and the potential therapeutic benefit that VOCERYQ can provide.
We believe it has the potential to transform the treatment paradigm for this disease by delivering what we understand matters most to patients, reducing the need for surgery. This is a pivotal moment for RRP patients who have faced a relentless cycle of surgery for far too long with limited treatment options, and for Inovio, as we move forward into an exciting new chapter as a commercial-stage company. Going forward, our primary focus will be maximizing the opportunity we see for VOCERYQ and executing our commercial launch with the goal of establishing it as the preferred first-line treatment for adults with RRP. To support those efforts, we recently completed an equity offering that provided approximately $80.5 million in net proceeds.
These proceeds, together with our existing cash resources and subsequent warrant exercise proceeds, are expected to support operations into late fourth quarter 2027, past the launch of VOCERYQ, without taking potential expected product revenues into account. The approval of our first commercial product validates our platform and confirms our belief in the potential of our pipeline candidates to help patients suffering from other diseases. While our initial focus is on the successful launch of VOCERYQ within our broad adult indication, we will also be looking to expand the potential of VOCERYQ to serve additional indications within the RRP marketplace, both here in the U.S. and internationally.
We will also continue to prioritize partnerships to efficiently advance our clinical-stage candidates and look to establish new partnerships to advance promising earlier-stage candidates in our pipeline. This is truly a transformative time for Inovio and for DNA medicine, and we are excited about the significant opportunities ahead. I'll now turn it over to Mike Sumner, our Chief Medical Officer, to provide a few more details on the approval, product label, and supporting clinical data. Mike?
Thank you, Jackie. The approval of VOCERYQ is exciting on many fronts. It's Inovio's first approved product, the first FDA-approved plasmid DNA-based immunotherapy. Most importantly, an innovative and much-needed new treatment option for adults with RRP. I'd like to spend some time today providing a few highlights from the approval of VOCERYQ and its broad adult indication. VOCERYQ was evaluated in RRP001, a multi-site clinical study designed to assess what matters most to patients, reduction in surgery. The study followed 32 adult patients who had two to eight surgeries in the year prior to treatment. Patients had visible papillomas surgically removed before receiving their first dose of VOCERYQ. Patients then received four doses over a nine-week period. The primary efficacy endpoint was a reduction in surgery following dosing initiation. In this trial, we counted all surgeries after the first dose against the efficacy endpoint.
We also conducted study RRP002, a retrospective assessment of treatment effect up to three years after initial dosing in patients who had participated in the 001 study. The full clinical data from these studies were published in 2025 in Nature Communications and in The Laryngoscope, the top journal for the specialists who treat RRP. An additional analysis of data was also recently published in The Laryngoscope, supporting the ability of VOCERYQ to generate an immune response that linked to durable clinical benefit over the second and third years following initial treatment. These publications highlight the meaningful therapeutic benefit of VOCERYQ, with the vast majority of patients experiencing a 50%-100% reduction in surgery in year one, with durable responses and continued clinical improvement in year two.
The FDA's efficacy evaluation for Accelerated Approval focused specifically on the first-year treatment effect for 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, which included the surgical debulking required immediately prior to treatment. FDA's efficacy analysis started 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. As a reminder, this response was achieved without conducting any scoping or surgery during the dosing window. Patients going from needing three or more surgeries a year to needing zero surgeries following treatment would not be expected as part of the natural history of the disease.
In terms of safety, VOCERYQ was found 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, with the majority being grade 1. This slide lists the most common adverse reactions occurring in greater than or equal to 5% of patients, as described in the prescribing information. Of note, because VOCERYQ is a drug-device combination product composed of our plasmid DNA-based drug with delivery by our CELLECTRA device, this safety profile represents the combination product. For this approval, the safety data were further supported by data from prior clinical trials of VGX-3100, a HPV 16 and 18-related disease program, which included over 1,100 administrations and a placebo control. Delivery with our proprietary CELLECTRA device is well characterized and has also been shown in additional clinical studies to be well tolerated.
It is also important to point out here that reducing the need for surgery, both as part of or following treatment, is an important consideration for patients. Every surgery matters because every individual surgery comes with significant risk. Finally, I'd like to share a brief overview of our future confirmatory study. As VOCERYQ has 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, with the goal of aligning with the FDA on a final protocol by mid-2027. 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.
Subject to further regulatory feedback, 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 RRP patients can access treatment as quickly and efficiently as possible. Let's start by discussing the significant RRP market opportunity. Based on our ongoing analysis of claims data, we believe there's a prevalent population of at least 25,000 adult patients with RRP in the U.S., with additional patients diagnosed each year. Most patients continue to be managed surgically, and every single surgery comes with a risk of permanent vocal cord and airway damage. Key opinion leaders and the RRP Foundation stated in a position paper published in The Laryngoscope in January of this year that immunotherapy should be considered the first-line treatment for RRP, and that it should be started as soon as possible in the patient's disease journey to reduce the risk of permanent damage from repeated surgeries.
This position paper also noted that should VOCERYQ be approved by the FDA, it would be recommended as first-line therapy. To date, only a small fraction of the prevalent population of patients have been treated with immunotherapy, indicating there is a significant market opportunity for a non-surgical therapeutic treatment option designed to reduce the frequency of surgeries. Our goal is to establish VOCERYQ as the preferred first-line treatment for adults with RRP by leveraging what we believe are the key differentiating strengths of the product. VOCERYQ targets the root cause of RRP to deliver compelling efficacy, reducing the need for surgery. Importantly, it provides this efficacy without requiring scoping and surgical removal of visible papilloma during the dosing window, which makes it a patient-centric approach to treatment. VOCERYQ also has a favorable tolerability profile, with the potential to minimize disruption to patient lives.
For physicians, providing treatment is simple and straightforward. The device is designed to be easy to use and has a standard refrigeration requirement for drug storage that allows for flexibility in the location of administration. These strengths are what we believe can enable VOCERYQ to become the immunotherapy of choice for both patients and physicians. Looking at the patient journey in more detail, physicians and patients can discuss treatment with VOCERYQ as soon as a diagnosis has been established through the first biopsy or surgery. Once prescribed, the patient would undergo initial papilloma removal and then complete a four-dose treatment series over nine weeks. As we've noted in the label for VOCERYQ, there's no requirement to conduct scoping or surgery during the dosing window. This patient-centric approach helps to eliminate or reduce surgeries both during and after treatment.
Looking ahead, I'd like to outline our priorities to support 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 plan to engage targeted laryngologists and associated staff to educate on VOCERYQ and drive awareness and adoption. The focus will be communicating the unique value proposition of VOCERYQ. To support adoption, as soon as providers are ready to start prescribing VOCERYQ, we will provide CELLECTRA devices coupled with in-person 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 with a single point of contact to provide support around product ordering, 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 both 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 focused on efficiently reaching 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. Using a field deployment partner enables us to rapidly scale the team with highly experienced personnel as quickly as possible. As a rare disease, RRP is a concentrated market. About 400 laryngologists treat the vast majority of RRP patients. About 80% of these patients with RRP receive care in large IDNs or academic institutions, and 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 plan to engage both of these important customer segments, and overall, our field footprint is designed 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. 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 available to support the first year of launch through at least 2027.
We currently expect VOCERYQ to be available to order and ship in approximately 60 days from the approval date, and expect full field deployment during the first quarter of 2027. 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 will 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. With VOCERYQ as our primary focus, we plan to initially invest in exploring opportunities to expand its ability to serve the RRP community, including pediatrics and continued treatment options for adults. One of the strengths of our platform is the ability to provide additional doses that can continue to amplify the targeted T-cell response. We're also evaluating additional geographic markets, including the EU, U.K., and other international markets, and we plan to submit an application for conditional marketing authorization for VOCERYQ in Europe before the end of 2026.
As we look further ahead, we plan to leverage VOCERYQ's approval and the important validation of our DNA medicine platform to advance other promising candidates in the pipeline. Partnerships will continue to be important to advance 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 rare diseases like hemophilia A, Fabry disease, and hypophosphatasia. I'll now turn it over to our Chief Financial Officer, Peter Kies, for a financial update. Peter?
Thanks, Jackie. Today, I'd like to provide an overview of Inovio's finance results for the third quarter of 2026. With the upcoming launch of VOCERYQ, we are focused on supporting our commercial build-out. To support these efforts, we recently strengthened our balance sheet with an underwritten public equity offering that provided net proceeds of approximately $80.5 million after deducting underwriter discounts, commissions, and offering expenses. These resources, along with the $48.4 million in cash equivalents, and short-term investments at the end of the third quarter of 2026, and a further $10.9 million in proceeds from the exercise of warrants subsequent to September 30th, 2026, are projected to support operations into late fourth quarter 2027, past the launch of VOCERYQ. This projection includes an operational net cash burn estimate of approximately $21 million for the fourth quarter of 2026, as we ramp up our commercialization activities.
These cash runway projections do not include the contribution of revenues from sales of VOCERYQ expected to commence in 2027, or any further capital-raising activities that we may undertake, and are based on current projections and assumptions. Turning to our results for the third quarter, operating expenses decreased from $21.2 million in the third quarter of 2025 to $19.8 million in the third quarter of 2026. Inovio's net loss for the third quarter of 2026 was $49.2 million, or $0.50 per share basic and dilutive, compared to a net loss of $45.5 million, or $0.87 per share basic and dilutive, for the third quarter of 2025.
The increase in net loss was primarily driven by a $26.9 million non-cash loss on fair value adjustment related to our warrant liabilities for the third quarter of 2026, compared to a $22.5 million non-cash loss for the same period in 2025. As the fair value of the warrants fluctuate with our share price and other market inputs, this adjustment can result in significant variability in our reported net loss. As a reminder, you can find our full financial statements in this afternoon's press release, as well as in our quarterly report on Form 10-Q filed today with the SEC. With that, I'll turn it back over to Jackie.
Thanks, Peter. I'd 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 question-and-answer session. Should you have a question, please press star followed by the one on your telephone keypad. Should you wish to cancel your request, please press star followed by the two. If you're using a speakerphone, please lift the handset before pressing any keys. One moment, please, for your first question. Thank you. Your first question comes from the line of Roger Song from Jefferies. Please go ahead.
Hey. Congrats on the quarter, and thanks for taking our questions. This is Peter calling in for Roger. Just a couple from us. On the launch, with PAPZIMEOS's strong early uptake, where do you see VOCERYQ positioned to win at the launch? On durability, what do you think explains the year one to year two improvement in surgery-free rates, and what gives you confidence that this is a true deepening of response? Thank you.
Thanks. Great questions. To start off with the first one, I think what we're seeing with PAPZIMEOS in terms of the strong uptake that they've seen really indicates the high unmet need in this patient population. From our claims database analysis work, we estimate that there are about 25,000 patients in the U.S., adult patients in the U.S., with RRP. To date, immunotherapy has only reached a fraction of those patients. So we think there's a strong opportunity for VOCERYQ. We think with VOCERYQ's compelling efficacy, favorable tolerability profile, and a patient-centric treatment approach that doesn't require scoping and surgeries during the treatment window, that we have the potential to become the preferred first-line therapy in this space.
When we conduct market research, we found that the majority of patients, when given a choice, would prefer a therapy that doesn't require scoping and surgeries as part of the dosing window. So we're very confident in our product profile. I think you also asked a second part of your question in terms of durability. I think there, what I can say is we saw a very solid durability into the second year, which was also maintained into the third year. This was broadly across patients, regardless of the numbers of surgeries that they'd had in the year prior, regardless of types of HPV. Mike, anything you'd like to add to that?
Yeah, I mean, I'd sort of say this is also the focus of our recent publication in The Laryngoscope that I highlighted in my prepared remarks. We were very fortunate with our patients. We had three-year data going in, and with that durability data, we had a very complete picture of these patients. I think any statistical analysis that we performed, it showed that the treatment effect was both statistically and clinically meaningful.
Great. Thanks so much. It's very illuminating.
Thank you. Your next question comes from the line of Ted Tenthoff from Piper Sandler. Please go ahead.
Great. Thank you very much. Can you remind me sort of what the plans are? I know you mentioned that you're planning on submitting the MAA by year-end. What are your partnering plans for VOCERYQ overseas? Thank you, I have a quick follow-up.
Thanks, Ted. I will take the partnering question, and then maybe, Mike, you can provide some additional color on our plans to submit for conditional marketing authorization in Europe. In terms of partnering plans in the U.S., our plan is obviously to bring VOCERYQ to market ourselves. We do believe that we would benefit from partnerships in ex-U.S. territories, and we are actively seeking partnerships in those areas. Clearly, the upcoming submission of a conditional marketing authorization application in Europe is going to be supportive of those efforts. Mike?
Yeah. I mean, we obviously had discussions with our rapporteurs ahead of filing the application, and they were very supportive of us putting in a conditional marketing application. I think also now that we obviously have that application in process, there is also other geographical areas that we can look at expanding VOCERYQ in the approvals.
You know, and a quick follow-up, Mike, if I may. Are there countries where FDA approval grants approvals overseas, and would that be something where you could seek distribution partners? Have you thought about that as well?
Yeah. We have looked at that. I think we struggle with a lot of the regions that will accept an FDA approval do not have necessarily the resources to be able to fund a product like VOCERYQ. We are continually examining that as we look at our geographical expansion strategy.
That makes a lot of sense. I am just curious, with the approval of VOCERYQ, I know you guys have been developing the DPROT and the dMAb technology. Do you envision that that approval and that validation could accelerate or actuate partnerships for some of the early-stage programs for long-term protein and/or antibody expression? Thanks.
Yeah, that's a great question. Yes, in one word, we do see the approval of VOCERYQ as validation of the platform and of our delivery device, and we do think it's going to generate interest in the other programs in our pipeline. We are incredibly excited by the potential of our DPROT candidates to address other rare diseases. We've published clinical proof of concept data in terms of being able to produce monoclonal antibodies within the body for over 96 weeks without generating any anti-drug antibodies. So we're really excited by this potential. Mike, maybe you want to comment on some of the work that we've been doing across those indications and recent conference presentations.
I'd also like to just add, I mean, obviously from a regulatory point of view, we've talked before about the applicability of our non-clinical data across our platforms. I think with the approval of VOCERYQ, that clearly strengthened our CMC knowledge and also the fact that we have the first approved electroporation device in the world, I believe. That really strengthens our ability to rapidly move into new areas. Just as recently as this last weekend, I was able to present at the Soft Bones Conference with non-clinical proof of concept data for our ability to secrete alkaline phosphatase in a mouse model as a potential future therapeutic for hypophosphatasia. We've been at several hemophilia conferences earlier. So we're excited about where this platform is going.
If I can just add here—
Great.
When you look across our pipeline, there are really two key areas. The latest stage clinical candidates, including VOCERYQ, are really driving targeted T-cell responses.
Yeah.
The earlier preclinical candidates are really focused on protein replacement. We see these as two key strengths of the platform, where DNA medicines really have advantages over other platforms.
Great. Excellent. Well, congrats on the approval, and looking forward to continued progress.
Thank you.
Thank you. Your next question comes from the line of Yi Chen from H.C. Wainwright. Please go ahead.
Thank you for taking my questions. Could you tell us how many physicians have been trained to administer VOCERYQ using the CELLECTRA device? How many academic centers and community ENT practice do you plan to target during the initial period of the full field launch in the first quarter of next year?
Thanks, Yi. Mike, I will ask you to talk about our clinical experience with training physicians to date, then Steve, maybe you can take the commercial question.
Yeah. So, hi, Yi. In terms of familiarity with our device in the U.S., we obviously had the original eight clinical trial sites, which were some of our leading academic centers in the U.S. As we were preparing for our confirmatory study, we had potentially 20 sites there. There is good familiarity with the device. In terms of actually training, because of the ease of use of the device, training is actually accomplished in approximately 30 minutes. We have a field medical team ready to train, but that training really needs to be associated with the administration of the product. We will wait for the availability of the product in the field to really commence that training.
And then Steve?
Yeah. So in terms of, I think you asked about the number of accounts that we will be targeting. So, as I mentioned in the prepared remarks, in the integrated delivery system kind of segment of the business, these large academic institutions, about 80% of our RRP patients receive care, and most of them are concentrated in just about 100 accounts, and we will be in all 100 of those accounts once our full field team is deployed.
The other 20% receive care in community hospitals and physician practices, and we will engage there. We haven't shared kind of the number of accounts that we will be engaging, but what I can tell you is that that 20-person field territory team that we are deploying is designed to cover 90% of our RRP patient potential. So it will definitely be a broad effort once we are fully deployed in the first quarter of 2027.
Thank you.
Thank you. There are no further question at this time. I will now hand the call back to Ms. Jackie Shea for any closing remarks.
With the approval of VOCERYQ as our first product, Inovio has become a commercial stage company. This is a landmark moment of validation for 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 within a patient-centric treatment regimen that does not require scoping and surgeries during dosing, combined with a favorable tolerability profile and ease of use.
Our goal is for it to become the preferred first-line treatment option for RRP. We are focused on meeting the needs of patients and building long-term commercial success. We see multiple catalysts ahead, including in the near term, our first sales and revenue. We look forward to providing updates on our launch progress and delivering on the promise of our DNA medicine platform for all our stakeholders. Thank you, and good afternoon, everyone.
Thank you. This concludes today's call. Thank you for participating. You may all disconnect.