Inovio Pharmaceuticals, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Inovio Pharmaceuticals 4th Quarter 2024 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, March 18, 2025. And I would now like to turn the conference over to Ms. Jenny Wilson. Thank you. Please go ahead.

Good afternoon, and thank you for joining the Inovio Fourth Quarter 2024 Financial Results Conference Call. Joining me on today's call will be Dr. Jackie Shea, President and Chief Executive Officer, Dr. Mike Subner, Chief Medical Officer, Peter Keys, Chief Financial Officer, and Steve Egge, Chief Commercial Officer. Today's call will review our corporate and financial information for the quarter and year ended December 31st, 2024, 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 events relate to our business plans to develop Inovio's DNA medicines platform, which include clinical and regulatory developments and timing of clinical data readouts and planned regulatory submissions, along with capital resources and strategic matters. 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.innovio.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 today's call. After significant progress in 2024, we remain focused on transforming Inovio into a commercial stage company and delivering on the promise of DNA medicine for patients and shareholders alike. To achieve that goal, our work this year will be driven by three main strategic priorities. Submitting our BLA for INO3107, our lead candidate for recurrent respiratory papillomatosis, advancing our commercial plan and preparing for a fast and efficient launch, and leveraging the strengths of our platform to drive progress across our diversified pipeline. Advancing 3107 is our primary focus, and I am very pleased to report that we have resolved the previously announced manufacturing issue involving the single-use array component of this lecture device. Our next step is to perform the FDA-required Spice Verification Testing, known as DB testing, for the combined handset and single-use array required for our IMD and BLA submissions. We now plan to begin submitting our BLA under the FDA's rolling submission process, as well as commencing our confirmatory trial and requesting priority review in mid-2025. With this timeline, we anticipate being able to complete rolling submission in the second half of the year to enable the FDA to accept our BLA filing before the end of the year. Most importantly, we remain confident that if approved, 3107 could be the preferred non-surgical treatment for RRP for both patients and their physicians. A position that is strengthened by the year two and year three clinical data announced in December, and the detailed immunology data we published in February. Mike will provide more detail later in the call, but in our retrospective trial of 3107, patients showed continued improvement in reduction in surgery after year one, with 50% meeting criteria for complete response in the second 12-month period, or year two, meaning they were surgery free. Overall, the mean number of surgeries across the patient population continue to decrease into year three. The ongoing efficacy was observed is also supported by the immunology data published in Nature Communications, demonstrating the ability of 3107 to drive an antiviral immune response in airway tissue, so correlated with a reduced or eliminated need for surgery. We also published the full safety and efficacy data set for the completed phase 1-2 trial, which shows that the administration of 3107 was well tolerated. In summary, 3107 offers significant and durable clinical benefits, vulnerability, and a simple patient-centric dosing regimen that does not require scoping or surgery during the dosing window. all of which we believe could be compelling advantages once on the market. While our immediate focus is on advancing 3107, I'm also pleased to provide an important update from our work on next-generation DNA medicine. Together with our partners, we recently announced top-line interim results from an ongoing Phase I trial with our DNA-encoded monoclonal antibody technology, which we call DMAT. This proof of concept trial involved two DMADs targeting SARS-CoV-2 and showed that they can be durably and simultaneously produced in humans at biologically relevant levels. We believe this technology has the potential to overcome some of the biggest challenges with traditional recombinant monoclonal antibodies and could also transform treatment for a broad range of diseases by enabling long-term in vivo production of therapeutic antibodies or other proteins. Now I'll turn it over to Mike for some additional insights on our progress and new data on 3107. Mike?