Inovio Pharmaceuticals, Inc.

Good day and welcome to the Innovio Fourth Quarter 2020 Financial Results Conference Call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing star, then zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on a touch-tone phone. To withdraw your question, please press star, then two. Please note this event is being recorded. I would now like to turn the conference over to Ben Matone. Please go ahead.

Thank you, operator. Good afternoon, and thank you for joining the Inovio fourth quarter and year-end 2020 earnings conference call. On the call from the company are Dr. Joseph Kim, President and CEO, Mr. Peter Keyes, Chief Financial Officer, Dr. Jackie Say, Chief Operating Officer, Dr. Lermont Emo, Chief Scientific Officer, Dr. Kate Broderick, Senior Vice President of Research and Development, and Dr. Prakash Buyan, Senior Vice President of Clinical Development and Medical Lead for RevealOne, the company's Phase III clinical trial for cervical dysplasia. For today's call, we will review our corporate and financial information for the fourth quarter and full year ended December 31, 2020, as well as provide an update on our clinical program's progress, which includes our COVID-19 vaccine program and today's release regarding our Phase III clinical study for cervical dysplasia known as RevealOne. This call is being webcast live on our website, ir.innovio.com, and a replay will be made available. Following prepared remarks, we will be conducting a question and answer segment reserved for Equity Research Channel. During the course of this 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 integrated platform of DNA medicines, which include clinical and regulatory developments and timing of clinical data readouts, along with capital resources and strategic matters, as well as the impact of the COVID-19 pandemic on Inovio's business operations. All of these statements are based on the beliefs and expectations of management as of today. These statements involve certain assumptions, risks, and uncertainties that could cause actual results to differ materially. We assume no obligation to revise or update forward-looking statements, whether as a result of new information, future events, or otherwise. Investors should read carefully the risks and uncertainties described in today's press release as well as the risk factors included in today's 10-K filing with the SEC. I would now like to turn the call over to Inovio's president and CEO, Dr. Joseph Kipp.

Thank you, Ben, and good afternoon, everyone. We have a lot to discuss following this afternoon's Phase 3 BGX 3100 announcement, and I want to ensure we cover our other key programs and allow time for analyst questions. While we know that you are all eager to get updates about our COVID-19 vaccine program, I want to first spend some time on our latest announcement for Reveal-1 trial and what this means for both the HP therapeutic landscape and the Inovio platform validation. Later in the call, Dr. Prakash Buyan and Dr. Kate Broderick will discuss the latest developments in our HPV and COVID-19 vaccine programs. Also, our CFO, Peter Keys, will outline Inovio's strong financial position to support our deep pipeline, clinical development, and anticipated commercialization of multiple products over the next several years. What does today's news of Reveal One top-line data mean for the patients for Inovio? Today's data announcement represents a potential big step forward towards a therapeutic option for women who currently suffer from high-grade cervical dysplasia and who would like to avoid surgery, which is the current standard of care. The data demonstrated that in responders, three doses of VGX3100 resulted in regression of high-grade dysplasia and clearance of underlying HPV16 and or 18 virus. which caused the disease in the first place. Today also represents a giant milestone for the company. This afternoon's release on positive Reveal One efficacy data is the first phase three data reported by our company for Inovio's DNA medicine technology, further validating the company's platform technology that supports all of our therapeutic areas of focus. We are proud to advance the development of VGX3100 as the first DNA medicine to achieve efficacy endpoints in a phase three clinical trial. I am so thankful for all trial volunteers, study staff, and partners as well as Inovio team who are dedicated to bringing VGX3100 as a much needed non-surgical therapeutic option another step closer to commercialization especially in the face of a global pandemic. Before I turn it over to Dr. Buyen, who will discuss Reveal-1 data in greater depth, I do want to remind everyone that Reveal-1 is the first of two Phase III trials with VGX3100 for the treatment of cervical H-cell, and these trials are still ongoing. Reveal-1 subjects will continue to be followed for safety and durability of responses, for 18 months following the last administration of either VGX3100 or placebo with the trial completing later this year. Reveal 2 continues to enroll across eight countries, including the U.S. Both trials are designed to assess and confirm the safety, tolerability, and efficacy of VGX3100 in women 18 years of age or older who have histologically confirmed cervical dysplasia or H-cell. With an eye towards optimizing the commercial attractiveness of VGX3100, just last week, Inovio expanded its master collaboration agreement with Quiagen to co-develop a companion diagnostic based on RNA sequencing technology to help guide clinical decision-making for the use of VGX3100. The goal of this project is to develop a pretreatment RNA-based blood test for prospective VGX3100 patients to better identify the patients who are most likely to respond to VGX3100, which complements and raises the eventual commercial profile for VGX3100. This biomarker technology had previously been employed in a post-hoc assessment of VGX3100 phase 2b data by Novio, where it correctly predicted efficacy in 85% of VGX3100 3D subjects. We plan to have the companion diagnostic available prior to the licensure of VGX3100. With that, I would like now to turn the call over to Dr. Buyen, who will discuss today's release of Reveal-1 data. Prakash?