Inovio Pharmaceuticals, Inc.

Good day, and welcome to the Inovio First Quarter 2023 Financial Results Conference Call. All participants will be in a listen-only mode for the duration of the call, and should you need any assistance today, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your telephone keypad. And to withdraw a question, please press star, then two. Please also note that this event is being recorded today. 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 2023 First Quarter Conference Call. Joining me on today's call are Dr. Jackie Shea, President and CEO, Dr. Michael Sumner, Chief Medical Officer, and Mr. Peter Keyes, Chief Financial Officer. We also have other members of Inovio's leadership here with us today, who will be part of our Q&A session. Today's call will review our corporate and financial information for the quarter ended March 31st, 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. In the first quarter of 2023, we made solid progress with several key pipeline candidates. Notably, we made important headway in the development of INO3107, our product candidate for recurrent respiratory papillomatosis, or RRP. Our Chief Medical Officer, Dr. Mike Sumner, will provide more detail about our overall progress for this product candidate. But in short, since our last investor call, we received the initial feedback from the FDA on our proposed Phase 3 plans, leading us to believe we have an achievable framework for a Phase 3 trial for INO3107. We also announced that the European Committee for Orphan Medicinal Products issued a positive opinion on our application for orphan drug designation for INO3107, with the European Commission's final decision expected in May. These regulatory developments come on the heels of positive data from the second cohort of our Phase 1-2 trial for INO3107 shared in February, and additional combined data on the safety and immunogenicity of INO3107 that was presented by lead investigator Dr. Ted Mao at ABEA, a premier ENT meeting in Boston just last week. This data shows that INO3107 has the ability to elicit a robust immune response and has the potential to provide clinical benefit to patients who otherwise face a lifetime of disruptive surgeries. The data presented was accepted for publication by the Laryngoscope, one of the key journals read by physicians who care for RRP patients in APROS. In the first quarter, we also announced encouraging data from our Phase I trial with INO4201 as an Ebola booster for Avibo, which not only showed the potential of INO4201 as an important tool in extending protection against the Ebola virus, but also demonstrated the versatility of our platform and the ability of DNA medicines to elicit potentially protective immune responses across multiple indications. Additional safety and immunological data shared last month by lead investigator Dr. Angela Huntner at the 33rd European Congress of Clinical Microbiology and Infectious Diseases, or ECMID, provided more insight on the potential ability of INO4201 to generate robust immune responses and extend protection against Ebola. Mike will also share more details on that data. On our last earnings call in March, we announced top-line results for REVEAL-2, the second Phase III trial for VGX3100 as a treatment for cervical, high-grade squamous intraepithelial lesions or cervical H-cells. As we shared at that time, the trial results did not meet the primary endpoint in the biomarker-selected population, but did show statistical significance in the all-comers population. Since then, we've continued to analyze the data to better understand the biomarker population. Our goal is to share the results of this analysis with you in the third quarter of 2023. We continue to believe that the data from Reveal 2 which showed VGX3100's ability to promote viral clearance, highlights this drug candidate's potential to address the underlying cause of the disease, the HPV virus, which could make it an effective treatment option for additional indications, particularly anal H-cell. On INO5401, our collaboration with Regeneron continues. and as we wrap up the phase two study for this product candidate in glioblastoma. We still have patients on study that we are continuing to provide drug for, and we are evaluating next steps for this candidate, which we believe is worthy of further evaluation. While we've been making headway on the clinical front, we've also been able to maintain our financial position as we continue to expect our cash runway to take us into the first quarter of 2025. We will continue to ensure our strategic focus and financial discipline as we work to build on our important progress to date. An essential part of our strategy is ensuring that we have the resources and talent in place to advance our product candidates quickly and efficiently. This quarter, we welcome Dr. Cheryl Elder Senior Vice President of Regulatory Affairs to Inovio. She joins a seasoned product development team to oversee regulatory strategy and company interaction with global regulatory authorities. With over 30 years of experience leading cross-functional teams in drug development in multiple therapeutic areas, Dr. Elder has a successful track record of driving regulatory strategies within both small and multinational biotechnology companies, including Hoffman LaRoche and, most recently, Novartis Pharmaceuticals. I am confident we will benefit from her expertise as we seek to implement efficient regulatory strategies for key candidates across our pipeline. With that, I'd like to turn it over to our Chief Medical Officer, Dr. Mike Sumner, to provide some important clinical highlights.