Inovio Pharmaceuticals, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Inovio 3rd Quarter 2023 Financial Results Conference Call. At this time, online is in a less-than-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 Thursday, November 9, 2023. And I would now like to turn the conference over to Mr. Thomas Hong, Thank you. Please go ahead.

Good afternoon, and thank you for joining the Inovio 2023 third quarter conference call. Joining me on today's call are Dr. Jackie Shea, President and CEO, Dr. Michael Sumner, Chief Medical Officer, Mr. Mark Twyman, Chief Commercial Officer, and Mr. Peter Keyes, Chief Financial Officer. Today's call will review our corporate and financial information for the quarter ended September 30th, 2023, as well as provide a development progress update for our DNA medicines platform. 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, 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. Over the last few months, I'm delighted to say that we've made significant progress advancing our lead candidate, INO3107, for the treatment of recurrent respiratory papillomatosis, or RRP. After two very important regulatory developments, we are closer than ever to delivering on the promise of DNA medicines to patients and bringing the first DNA medicine to market in the United States. Specifically, in the third quarter of 2023, the FDA granted breakthrough therapy designation to INO3107 based on clinical evidence indicating that it may demonstrate substantial improvement over existing therapies for RRP. A couple of weeks following that breakthrough therapy designation, We received feedback from the FDA that data from our completed Phase 1-2 trial of 3107 could be used to support submission of a biological license application, or BLA, for review under the FDA's Accelerated Approval Program. Our Chief Medical Officer, Mike Sumner, will provide more context shortly, but this news means that we no longer need to complete a Phase 3 trial before BLA submission. and will ultimately allow for a potentially much faster development pathway. We will, however, be required to initiate a confirmatory trial and satisfy all other FDA filing requirements prior to BLA submission, as is usual for the accelerated approval pathway. To achieve that, our team has already submitted a request for an initial comprehensive multidisciplinary breakthrough therapy meeting the FDA for the fourth quarter. This meeting will help further align our plans with the FDA and determine the timing for critical deliverables associated with our BLA submission. As we make progress on this new expedited pathway, we have every intention to utilize the opportunity for increased communication with the FDA and other advantages offered by breakthrough therapy designation. such as requesting a rolling submission of completed sections of our BLA and a priority review of the fully submitted BLA. As a result of this new timeline, we have accelerated our commercialization strategy to be prepared to launch 3107, should it be approved. Led by Mark Twyman, our Chief Commercial Officer, whom you'll hear from shortly, our commercial team has extensive experience bringing products to market. including innovative new technologies and products in the rare disease space. Mark will spend a few moments today talking about his team's current efforts to expedite building a number of critical capabilities and establishing pathways for commercial success, such as creating the value proposition for 3107, putting in place an optimized distribution model, developing payer speciality pharmacy, and pharmacy benefit management strategies to ensure favorable access and preparing to stand up a field organization. Mark and his commercial leadership team bring decades of combined biopharmaceutical experience from such companies as Sanofi Genzyme, Merck, CSL Bearing, and MedImmune. They've been personally involved in nearly every aspect of successfully commercializing products, from sales and marketing to distribution, market access, and government affairs. I am really pleased with the progress of this team as they worked hand in glove with leaders from across the company to optimize the launch plans for our lead candidate. In addition to the regulatory achievements and commercial readiness efforts I've described, we've worked very hard over the past 18 months or so to restructure our corporate organization with the goal of meeting our current focus pipeline needs and reducing spending, while at the same time retaining and building the expertise critical to implement our plans for our late stage pipeline. After many difficult months and quarters, I'm pleased to see the collective efforts of our dedicated and experienced cross-functional team make a real difference. With that, I'd like to turn it over to our Chief Medical Officer, Dr. Mike Sumner, to provide a brief overview of the regulatory and development progress we've achieved for 3107, the next steps on our accelerated development timeline, and other key preparations to support a BLA submission and, if approved, to bring this candidate to market.