Inovio Pharmaceuticals, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Inovio Second 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 zero for the operator. This call is being recorded on Tuesday, August 12, 2025. I would now like to turn the conference over to Jenny Wilson. Please go ahead.

Good afternoon, and thank you for joining the Inovio Second Quarter 2025 Financial Results Conference Call. Joining me 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 June 30, 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, 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 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.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. Jackie Shea.

Good afternoon, and thank you for joining today's call. I'd like to start today by highlighting the important progress we've made so far this year as we work to achieve our key strategic priorities. Most importantly, I'm very pleased to report that we remain on track to submit our BLA for INO 3107 in the second half of this year, thanks to several key accomplishments. We have completed the design verification or DV testing of our Selectra 5PSP device which allows us to move forward with the next key regulatory milestones for this program. Utilizing the breakthrough therapy designation awarded by the FDA to 3107, we have also requested rolling submission of our BLA. Our goal is to complete the submission and receive file acceptance by year end. We plan to request a priority review of our BLA, which, if accepted, would provide us six months for review of the file. potentially providing for a PDUFA date around the middle of 2026. I'm also pleased to report that in addition to the publication of our Phase I-II clinical data in Nature Communications earlier this year, data from our retrospective study on the long-term clinical effect of 3107 have been published in the Laryngoscope, the leading journal for physicians who treat RRP. These data are an integral part of our BLA submission package and core to our belief that 3107 could become the preferred product for patients and providers alike. Mike and Steve will provide further details shortly. While we continue to drive progress on the regulatory front, we have also continued working to advance our commercial plans, ensuring that we are prepared for a swift and efficient launch should 3107 be approved. That includes engaging in further market research and continuing to refine our go-to-market plans. And finally, while we are primarily focused on the BLA submission for our lead asset 3107, we are excited about the potential of our broader pipeline. Most recently, we've had opportunities to highlight the broad therapeutic potential of our next generation DNA medicine technology, including sharing the top line data from a phase 1-2 trial of our DNA-encoded monoclonal antibody, or DMAP technology, in a preprint on Research Square, and featuring DMAPs and our DNA-encoded protein replacement, or DPROP technology, in a presentation at the Orphan Drug Summit in Boston this past July. We believe there are multiple diseases or medical conditions that our DPROP platform could successfully target and we are actively seeking partnerships to advance this technology into the clinic. I look forward to sharing more on our progress there in the coming months. With that, I'll turn it over to Mike for an update on our progress with 3107.