Inovio Pharmaceuticals, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Inovio First 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 zero for the operator. This call is being recorded on Monday, May 13, 2024. I would now like to turn the conference over to Thomas Hong, Manager of Investor Relations. Please go ahead.

Good afternoon, and thank you for joining the Inovio First Quarter 2024 Financial Results Conference Call. Joining me on today's call are Dr. Jackie Shea, President and Chief Executive Officer, Dr. Michael Sumner, Chief Medical Officer, Mark Twyman, Chief Commercial Officer, and Peter Keyes, Chief Financial Officer. Today's call will review our corporate and financial information for the quarter ended March 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'll 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. 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. To begin with today, I'd like to discuss our key objectives for 2024. Mike, Mark, and Peter, We'll go into greater detail throughout this presentation, but I feel it's important to emphasize the recent progress we've made in the three main areas that are driving our business forward. Firstly, preparing for the potential approval and commercialization of our first product, INO3107, which is being developed for the treatment of recurrent respiratory papillomatosis. Secondly, advancing other promising candidates in our pipeline, particularly INO 3112, and thirdly, strengthening our business as a whole. Over the last two years, our strategic focus on these areas has been instrumental in ensuring that we are using our time and resources efficiently to work toward a common goal, to deliver on the promise of DNA medicines to patients. Of utmost importance, we remain on track to file our BLA for 3107 in the second half of this year, under the FDA's accelerated approval pathway. And we believe we have alignment with the FDA on our proposed confirmatory trial design based on recent feedback. Our team is energized by the opportunity to deliver the first potential FDA-approved therapy for this devastating disease. And we're now moving to initiate the trial as soon as possible. As you'll hear from Mark, we have also been advancing our commercial plans for 3107 establishing key relationships, and putting the building blocks of a successful commercial launch strategy into place. In parallel, our clinical and R&D teams have continued to advance other promising candidates across the pipeline, focusing on later stage assets with high unmet medical need and strong commercial potential. We believe we have reached alignment with the FDA on the phase three trial design for 3112 in combination with LactoC for throat cancer. And we'll focus next on discussing those plans with European regulators. Following feedback from the FDA, we also expect to submit plans for a Phase 2-3 study with INO4201 as an Ebola vaccine booster in this quarter. And look forward to a readout of the first clinical data from the phase one trial evaluating the anti-SARS-CoV-2 DMAB candidates in the second half of this year. Finally, we've continued to strengthen our business, adding key personnel, managing our resources, and strategically strengthening our financial position to support our key objectives. Of particular note, we recently raised approximately $33 million through an offering of common stock and pre-funded warrants in April. We remain committed to financial discipline and operational excellence to achieve milestones, which I believe will continue to be critical to our future success. I'd now like to pass the call over to our CMO, Mike Sumner, who will provide some additional details on 3107 and our other clinical progress across the pipeline. Mike?