Inovio Pharmaceuticals, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Inovio First Quarter 2025 Financial Results 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 today, Tuesday, May 13, 2025. I would now like to turn the conference over to Jenny Wilson, Director of Communications. Jenny, please go ahead.

Good afternoon, and thank you for joining the Inovio First 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 March 31, 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 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. Jackie Shea.

Good afternoon, and thank you to everyone for joining today's call. First of all, I am very pleased to say that we remain on track to submit our BLA for INO3107, our lead candidate for treatment of recurrent respiratory papillomatosis, or RRP. As previously stated, our goal is to begin rolling submission in mid-2025, complete the submission in the second half, and receive file acceptance by the end of this year. This would allow for a PDUFA date in mid-2026 if we receive priority review. Our primary focus continues to be the submission of our BLA for 3107. We reported in March that we had resolved the manufacturing issue involving the single-use array component of this Electra device, and we have now moved on to the next step, initiating the device design verification testing, known as DB testing. required for our IND update and BLA submissions. We've also been pursuing targeted opportunities to highlight key data from our completed Phase 1-2 trial. We were delighted to announce the publication of clinical and immunology data from that trial in Nature Communications in February. We also look forward to the publication of the previously announced data on the longer-term clinical effect of 3107. which has been submitted to a peer-reviewed journal. In addition, we've been very active at scientific conferences this spring, which has been integral to our strategic outreach to healthcare providers and key opinion leaders. Mike will provide an update on that shortly. On the commercial readiness front, ongoing market research with physicians, patients, and payers continues to support our belief that 3107 has the potential to be the preferred product for patients and physicians if approved. Steve will provide a brief overview of both market opportunity and insights from our market research with healthcare providers later in the call. And finally, a highlight from our earlier stage pipeline this quarter was the announcement of promising interim results from an ongoing phase one proof of concept trial evaluating DNA encoded monoclonal antibodies or DMAPs. We're excited about the potential of this next generation technology and what it could mean for the future of our DNA medicines pipeline. With that, I'll turn it over to Mike for a brief update on our progress with 3107 and some highlights from our recent presentations. Mike? Thanks, Jackie.