Inovio Pharmaceuticals, Inc. 2026 Q2 Earnings Call

Good afternoon, and thank you for joining the Inovio second quarter 2026 financial results conference call. Joining me today are Dr. Jacqueline Shea, President and Chief Executive Officer, Dr. Michael 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 June 30, 2026, as well as provide a general business update. Following prepared remarks, we will conduct a question and answer segment. During the call, we will be making forward-looking statements regarding future events and the future performance of the company. These statements relate to our business plans to develop Inovio's DNA medicines platform, including the FDA's ongoing review of our BLA for INO-3107, including the October 30, 2026 PDUFA target date, and our recently completed informal meeting with the FDA.

Our belief that INO-3107 fulfills the criteria for accelerated approval, the potential benefits of INO-3107, including our belief that it has a positively differentiated product profile. Our belief regarding its competitive advantages relative to existing treatments, including Pepzimos, and the potential to become the preferred product and new standard of care for patients and their physicians, if approved. Our expectation to receive orphan drug market exclusivity for INO-3107, if approved, and the anticipated timing of label negotiations. The anticipated commercial launch of INO-3107, if approved. Our commercial launch infrastructure and preparations. Our engagement of commercial partners, including Syneos Health and other third-party partners in preparation for a potential launch. The recent positive phase III data announced by our partners for Greater China for VGX-3100 as a potential treatment for cervical dysplasia and ApolloBio's plans to seek regulatory approval for VGX-3100 in China based on that data.

The advancement of our DPROT technology platform. Capital resources, including our estimated operational net cash burn of approximately $18 million for the third quarter of 2026, and the expected sufficiency of our cash resources into late first quarter 2027 and through a potential launch of INO-3107. Our expectations regarding competition, market size, and acceptance of INO-3107, if approved. 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 by the company verbally, as well as statements made within 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. Jacqueline Shea.

Good afternoon, and thank you to everyone for joining today's call. Since our last quarterly call in May, the FDA's review of our BLA for INO-3107 has continued to advance with several important steps in the regulatory process now complete. We are on track for the October 30th target PDUFA date, and while Mike will go into greater detail on our regulatory progress, the highlights are that the FDA has completed its late-cycle review meeting and completed all of the scheduled pre-licensure inspections. The FDA also granted the previously requested informal clinical meeting, where we had the opportunity to present the totality of data supporting INO-3107's safety and efficacy and highly differentiated approach in treating RRP, a chronic HPV-related disease that has a devastating impact upon patients.

We believe there remains significant unmet need for treatment options that reduce the need for RRP-related surgery, and we believe the efficacy, tolerability, and patient-centric approach of 3107 could enable it to become established as the new standard of care. With that goal in mind, we have continued advancing our commercial launch preparations, including initiating the build of our critical launch infrastructure, which Steve will expand upon. We also completed an equity offering that provided approximately $18.3 million in net proceeds in late July to support these efforts, which we expect to extend our runway into late first quarter 2027 and through a potential launch of 3107, if approved. While our resources are focused on advancing 3107, Inovio's partnerships have enabled important progress with other promising candidates across our pipeline.

ApolloBio, our partner for VGX-3100 in Greater China, announced positive top-line results from its pivotal phase III trial as a potential treatment for HPV 16 or 18 positive cervical dysplasia. This further highlights the potential of Inovio's DNA medicine platform as a non-surgical treatment option for HPV related diseases. Inovio also presented promising preclinical data on our next-generation DNA-encoded protein, or DPROT technology, targeting factor VIII production for the treatment of hemophilia A at several scientific conferences during the second quarter. Of note, we have added two new rare disease targets for the platform, Fabry disease and hypophosphatasia. I'll now turn it over to Mike for some additional details on our regulatory progress with 3107.

Thanks, Jackie. As Jackie noted, over the past several months, we have made considerable progress with INO-3107 on the regulatory front as the FDA's review of the BLA continues to advance under the agency's accelerated approval program. The FDA has now completed its late-cycle review meeting and all scheduled pre-licensure inspections, which included clinical, drug manufacturing, in-house drug testing, and our delivery device facility. I am pleased to say that there was only one reported observation from the inspections, which we believe we have appropriately addressed, and we are in the process of submitting our response to the FDA. Following the recent change of leadership at CBER and the Office of Therapeutic Products, the FDA also held our clinical informal meeting in July.

During this meeting, we had the opportunity to present the totality of data supporting the safety and efficacy of 3107 and highlight its highly differentiated approach in treating RRP. We continue to believe we have provided a strong rationale for eligibility under the accelerated approval program, highlighting the ongoing need in the RRP community for therapeutic alternatives to existing treatments, while also sharing our rationale for how 3107 demonstrates a meaningful therapeutic benefit over those existing treatments. During this informal meeting, the FDA noted that the BLA review was ongoing and did not discuss their preliminary conclusion regarding accelerated approval eligibility, which was noted as a potential review issue in the December 2025 file acceptance letter. They did, however, indicate that their feedback on the design of our confirmatory trial will be forthcoming.

To provide more context around 3107's eligibility for accelerated approval when there is already an existing product that has received a full approval, the FDA's guidance indicates that a product candidate reviewed under the accelerated approval program should provide both a meaningful therapeutic benefit over existing treatments and meet a remaining critical unmet need among patients. We believe that 3107 meets both of those criteria based on three factors. First, clinical efficacy as demonstrated in our phase I/II trial where the vast majority of patients experienced a 50%-100% reduction in surgery in year one, with continued clinical improvement in year two.

Second, 3107 has been shown in clinical studies to be well-tolerated, potentially offering a beneficial safety profile that does not include the requirement for scoping and surgery during the dosing window to maintain minimal residual disease, or MRD, which is required for Pepzimos and included in their labeling. Third, 3107 has a differentiated mechanism of action, not impacted by preexisting neutralizing antibodies or an immunosuppressive tumor microenvironment, both of which may impact the efficacy of Pepzimos. These three key strengths, clinical efficacy, safety, and a differentiated MOA, underpin why we believe 3107 is eligible for review under the accelerated approval program and has the potential to become the new standard of care for RRP. Importantly, a representative from the RRP Foundation and a healthcare provider specializing in the treatment of RRP were able to join the informal meeting as well.

Both provided statements reiterating the significant continuing unmet need in the RRP community and their belief in the ability of INO-3107 to meet those needs. From the start of our development work on a treatment for RRP, we have been working closely with the foundation, patients, and other RRP experts to understand and highlight what matters most to them, providing every patient with relief from the risks and costs that come with every surgery. We are thankful for their continued support as we work to deliver on the promise of INO-3107 for patients. We believe we are now in the final stages of the regulatory review process and anticipate starting label negotiations in September. It is also important to note here that if approved, we would expect to receive seven years of orphan drug market exclusivity for INO-3107 based on our differentiated delivery and mechanism of action.

Finally, we are also initiating our medical science liaison team to begin scientific engagement with potential customers. With that, I will now turn it over to Steve to provide an update on our commercial progress and strategy.