INO earnings call transcript, November 9, 2026

And thank you to everyone for joining. I'd like to start today's call by highlighting the recent FDA approval of FASERIC, formerly known as INO3107, under the exception. 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 the CEREC was a groundbreaking therapy and that its approval represented a meaningful scientific breakthrough by offering patients a plasma. DNA-based immunotherapy that harnesses the body's own immune system to fight the underlying cause of RRP. The accelerated approval for CEREC 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 Viseric 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 Viseric 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 net proceeds. These proceeds together with our existing cash resources and subsequent warrant exercise proceeds are expected to support operation. into late fourth quarter 2027 past the launch of a CEREC 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 a CEREC within our broad adult indication, we will also be looking to expand the potential for CEREC 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 stages. 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?

The approval of Verseric is exciting on many fronts. It's Inovio's first approved product, the first FDA approved plasmid. DNA-based immunotherapy, and 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 you. Approval of the CEREC and its broad adult indication. The CEREC was evaluated in RRP-001, 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 papilloma surgically removed before receiving their first dose of Thoseric. 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 effects... ...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 Viseric 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 Viseric, with the vast majority of patients experiencing a 50% to 100% reduction in surgery in year one, which... Durable responses and continued clinical improvement in year two. The FDA's efficacy evaluation for accelerated approval focused specific... ...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 9. In the following 12 months, 27% of the patients achieved complete response, as defined by not requiring any surgeries to manage their disease. And 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, BOSERIC 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 FOSERIC is a drug-device combination product composed of our plasmid DNA-based drug with delivery by our Selectra device, this safety profile represents the combination product. For this approval, the safety data were further supported by data from prior clinical trials of the PGX 3100, a HPV 16 and 18 related disease program, which included over 1,100 administrations. And the placebo control. Delivery with our proprietary selector 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 VOSERIC 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 BOSERIC.

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 Eggie, our Chief Commercial Officer, for an overview of our commercial launch plans. Steve?

We're excited. to launch Voseric 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 United States 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 opinions. 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 Viseric 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-certified... ...surgical therapeutic treatment option designed to reduce the frequency of surgeries. Our goal is to establish Voceric as the preferred first-line treatment for adults with RRP. By leveraging what we believe are the key differentiating strengths of the product, Voceric targets the root cause of RRP to deliver compelling...

...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. Boceric also has a favorable tolerability profile with the potential to minimize disruption to patient lives. And 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 voceric 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 voceric 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 voceric, 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 Luceric 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. that 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. 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 voceric and drive awareness and adoption. The focus will be communicating the unique value proposition of voceric. To support adoption, as soon as providers are ready to start prescribing voceric, we will provide selector 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 VOSERIC support program with a single point of contact to provide support around product ordering, patient benefit investigation and verification, co-pay 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 voceric 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 to our field deployment partner, Cineos 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 a hundred 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 plasma 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 voceric 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 were 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.

The approval of the CEREC is a pivotal milestone. For Inovio, that we believe offers many exciting opportunities to drive progress across the Inovio pipeline. With Viseric 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, UK, and other international markets. And we plan to submit an application for conditional marketing authorization for Viseric. in Europe before the end of 2026. As we look further ahead, we plan to leverage Viseric's approval and the EU. 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 D-PROC candidates in rare disease. We believe these investigational protein replacements therapies have the potential to transform the treatment paradigm for rare diseases like hemophilia A, Fabry disease, and hypophosphatasia. I'll turn it over to our chief financial officer, Peter Keith, for a financial update. Peter?

Today I'd like to provide an overview of Inovio's financial results for the third quarter of 2020. With the upcoming launch of Viseric, 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 this, conducting underwriter discounts, commissions, and offering expenses. These resources, along with the $48.4 million in cash, cash equivalents, and short-term investments, at the end of the third quarter of 26, and a further $10.9 million in proceeds from the exercise of warrants subsequent to September 30, 2026. projected to support operations in due late fourth quarter, 2027, past the launch of Buceric. This projection includes an 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 Versarex 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.

or 50 cents per share basic and dilutive compared to a net loss of 45.5 million or 87 cents per share. 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. 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 and 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 course.

And with that, I'll turn it back over to Jackie.

I'd now like to pause to open up the call to answer any questions you might have.

Thank you. And your first question comes in the line of Roger Song from Jefferies. Please go ahead.