8/12/2026

speaker
Operator
Conference Operator

Good afternoon, ladies and gentlemen, and welcome to the Inovio Second Quarter 2026 Financial Assaults Conference Call. At this time, all lines are in a 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 zero for the operator. This call is being recorded on Wednesday, August 12, 2026. I would now like to turn the conference over to Jennie Willson, Director of Communications. Please go ahead.

speaker
Jennie Willson
Director of Communications

Thank you. Good afternoon, and thank you for joining the Adnopio Second Quarter 2026 Financial Results Conference Call. Joining me today are Dr. Jackie Shea, President and Chief Executive Officer, Dr. Mike Sumner, Chief Medical Officer, Steve Ege, 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 Thank you for joining us today. Our belief regarding its competitive advantages relative to existing treatments, including Pepsimios, 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. are engagement of commercial partners including Cineos Health and other third-party partners in preparation for a potential launch. The recent positive phase 3 data announced by our partners for Greater China for VGX3100 as a potential treatment for cervical dysplasia and ApolloBio plans to seek regulatory approval for VGX3100 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, and 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. I will now turn the call over to Inovio's President and CEO, Dr. Jackie Shea.

speaker
Dr. Jackie Shea
President and Chief Executive Officer

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 IMO 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-license year inspections. The FDA also granted the previously requested informal clinical meeting where we had the opportunity to present the totality of data supporting INO3107'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. Apollo Bio, our partner for BGX 3100 in Greater China, announced positive top-line results from its pivotal Phase 3 trials, as the 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 pre-clinical data on our next-generation DNA-encoded protein or DPOP technologies, targeting Factor VIII production, for the treatment of haemophilia ray at several scientific conferences during the second quarter. Of note, we have added two new rare disease targets for the platform, Fabry disease and hyperphosphatasia. I'll now turn it over to Mike for some additional details on our regulatory progress with 3107. Thanks, Jackie.

Disclaimer

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