Inovio Pharmaceuticals, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Inuvio 3rd Quarter 2025 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 Monday, November 10, 2025. And I would now like to turn the conference over to Jenny Wilson. Thank you. Please go ahead.

Good afternoon, and thank you for joining the Inovio Third Quarter 2025 Financial Results Conference Call. Joining me today on today's call are Dr. Jackie Shea, President and Chief Executive Officer, Dr. Mike Sumner, Chief Medical Officer, Peter Keyes, Chief Financial Officer, and Steve Egge, Chief Commercial Officer. Today's call will review our corporate and financial information for the quarter ended September 30th, 2025, as well as provide a general business update. Following prepared remarks, we will conduct a question and answer session. 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 of our request for priority review by the FDA of our BLA submission for INO3107. and our expectation that the FDA will accept the submission by the end of 2025, along with capital resources, including the sufficiency of our cash resources, our expectations regarding competition, the size and growth of the potential markets for INO 3107, if approved, and our ability to serve those markets, the rate and degree of market acceptance of INO 3107, 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 risk factors heading 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.anovio.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 for joining today's call. Today, I'm very pleased to share some important updates on the key progress we've made recently. First and foremost, we have achieved our primary objective for this year, which is completing the rolling submission of our BLA for INO 3107. This represents a milestone in our work to deliver on the promise of DNA medicine for the RRP community, and as our first BLA submission, an important moment for Inovio as well. We are now focused on the next steps in the process of bringing 3107 to patients. First, we expect to receive file acceptance by the FDA by year end, and we have requested a priority review of the BLA, which, if granted, would provide for a potential PDUFA date around mid-2026. Second, we are continuing to drive commercial efforts forward in preparation for a swift and efficient launch, if approved. Although we will be second to market, we continue to believe that INO3107 has compelling advantages that could make it the preferred treatment by RRP patients and their healthcare providers. based on its clinical results and tolerability to date, and the simplicity of its patient-centric treatment regimen. As we work toward a potential launch date for our first commercial product, we're also advancing our next-generation DNA medicine candidates. I'm pleased to report that landmark, proof-of-concept data on our DNA-encoded monoclonal antibody, or DMAB technology, was recently published in Nature Medicine. We are also preparing for an upcoming presentation of promising preclinical data from our DNA-encoded protein, or DPROC, technology at the World Federation of Haemophilia Global Forum. Both of these programs leverage a key strength of our DNA medicine platform, the ability to drive sustained, targeted protein production within the body. We believe our DMAP and DPROC technologists have immense potential to treat multiple diseases, and I look forward to sharing more on our progress in the coming months. Now, I'll turn it over to Mike for some additional details about our regulatory progress and next steps for 3107. Mike?