Inovio Pharmaceuticals, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Indovu Second 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 Thursday, August 8, 2024. I would now like to turn the conference over to Thomas Hall, Manager of Investor Relations. Please go ahead.

Good afternoon, and thank you for joining the Inovio Second Quarter 2024 Financial Results Conference Call. Joining me on today's call are Dr. Jackie Hsieh, President and Chief Executive Officer, Dr. Michael Sumner, Chief Medical Officer, Peter Keys, Chief Financial Officer, and Steve Egge, Chief Commercial Officer. Today's call will review our corporate and financial information for the quarter ended June 30th, 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 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.

Thank you, Thomas. Good afternoon, and thank you to everyone for joining today's call. To begin with today, I'd like to discuss the progress we've made thus far for 2024 based on the goals we set out at the beginning of this year. That includes advancing our lead INO 3107 development program, advancing other promising candidates in our pipeline, and finally, strengthening our business as a whole. Our primary focus has been working towards the potential commercialization of 3107 for the treatment of recurrent respiratory papillomatosis, or RRP. We have made significant progress preparing our BLA package and expect all non-device related elements to be completed by year end. A positive pre-BLA meeting with the FDA last week provided us with further confidence that we remain on the right track for submission. We've also made important regulatory progress in both the UK and Europe and have continued to advance planning for our redosing trial. However, as announced earlier today, we have identified a manufacturing issue with the single-use disposable administration component of our devices. during the testing process required to support our BLA filing, and that will impact the timing of our BLA submission. Every day matters to patients, and we're working to resolve this issue as quickly as possible. Our chief medical officer and RRP program lead, Mike Sumner, will provide more details, but I want to emphasize that we're confident in our path forward and remain focused on the opportunity to deliver not only what could be the first FDA-approved therapy for this devastating disease, but the first DNA medicine approved for use in the United States. What's more, Inovio has continued making progress on other key objectives for both the near and longer term to deliver value to stakeholders. Elsewhere in our pipeline, we've submitted our Phase III trial design for INO31 and 12 in combination with Loctorsi, for the treatment of throat cancer to the European Medicines Agency for review. We're also planning to submit our phase two trial for INO4201 as an Ebola vaccine booster to the FDA later this month and have advanced discussions with partners for the next trial for INO5401 in glioblastoma, a deadly brain cancer. At the same time, We've continued to strengthen our business by prioritizing financial discipline and operational excellence. As Peter will discuss shortly, we closed the second quarter with $110 million in cash and short-term investments, with no debt on our balance sheet, and raised approximately $33 million through an offering of common stock and pre-funded warrants this past April. We estimate that our current cash will be sufficient to fund our operations, into the third quarter of 2025. We also recently welcomed Steve Egge as our new Chief Commercial Officer, and I'm delighted to have him join our leadership team. Steve has broad therapeutic area experience, including in HPV-related diseases and cancers, vaccines, and rare disease, and his career has spanned both biotech and large pharma. Steve recently launched a new women's health product at My Advanced Sciences, which was later acquired by Sumitomo Pharma. He also spent 20 years at Merck, where he held a number of senior commercial leadership roles, including leading their HPV vaccines franchise and serving as chief marketing officer for the vaccine division. Over the course of his career, he has overseen or contributed to more than a dozen commercial product launches. His broad commercial expertise will be invaluable as we work to advance 3107 and our other promising candidates. I'd like to invite Steve to share more about why he joined Inovio and the potential he sees for 3107. Steve?