Inovio Pharmaceuticals, Inc.

Welcome to the Inovia Third Quarter 2021 Financial Results Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by a 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. 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 Matan Senior Director of Investor Relations. Please go ahead.

Thank you, Operator. Good afternoon, and thank you for joining the Inovio Third Quarter 2021 Earnings Conference Call. Joining me on today's call are Dr. Joseph Kim, President and CEO, Mr. Peter Keyes, Chief Financial Officer, Dr. Jackie Shea, Chief Operating Officer, Dr. Laurent Humeau, Chief Scientific Officer, Dr. Jeffrey Skolnick, Senior Vice President of Clinical Development, Dr. Anza Mammon, Senior Vice President of Clinical Development, and Dr. Kate Broderick, Senior Vice President of Research and Development. For today's call, we will review our corporate and financial information for the third quarter ending September 30th, 2021. We will also discuss our COVID-19 vaccine development efforts that address both current and future variants of concern, as well as our efforts around both homologous and heterologous boosting. Additionally, We will review other recent developments associated with Inovio's various therapeutic and vaccine programs across our DNA medicine platform. Among our recent updates, we'll address the progress from our company's global Phase 3 Innovate trial, which involves our COVID-19 DNA vaccine candidate, INO4800, with our partner vaccine, as well as our announcement this morning that the U.S. Food and Drug Administration has lifted the partial clinical hold of the Phase 3 segment of Innovate in the U.S. Following prepared remarks, we will be conducting a question and answer segment reserved for equity research analysts. 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 integrated platform, DNA Medicine, which include clinical and regulatory development 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 on our website, ir.inovio.com, and a replay will be made available shortly after this call is concluded. Now, I'd like to turn the call over to Inovio's President and CEO, Dr. Joseph Kim.

Thank you, Ben, and good afternoon, everyone. I appreciate you taking time to join us this afternoon. Let me begin by stating how pleased I am with the progress that we've made over the last few months, and I'm grateful for the opportunity to share some additional context and discuss our efforts during this call. The global community continues to deal with the impact of the COVID-19 pandemic, and evolving variants of concern. Global vaccination rates are approximately 50%, but rates are still below 5% in certain areas of the world. Too many people are still without access of COVID-19 vaccines. Inovio recognizes the important role we can play in supporting the global response to this public health crisis and remain focused on the continued need for safe and effective vaccines for both as primary vaccination series and as a booster vaccination. We're excited that dosing for our innovate trial is underway and enrollment continues globally. To that point, and just to recap, we have received regulatory authorization to proceed in a total of seven countries to date, which includes Mexico, Brazil, the Philippines, Colombia, India, the United States, and Thailand, with additional countries projected to follow. Together, we're aiming to have the interim phase three efficacy data from this trial in the first half of 2022. Pending clinical efficacy data, the company plans to apply for emergency use authorization in respective countries. Very quickly, and just to further expand on Colombia, in addition to receiving regulatory authorization to conduct our phase three trial, Inovio also signed a non-binding memorandum of understanding with Colombia's Ministry of Health and Social Protection, reflecting our mutual intent to advance efforts to combat the continued threat posed by COVID-19 as well as to better prepare for future public health emergencies in Colombia. The agreement creates a framework for collaboration under which Inovio and Colombia's government can explore knowledge sharing, technology licensing, and capacity building towards developing and producing vaccines, along with other biopharmaceuticals in Colombia. This morning, as you probably have read, Inovio announced that the U.S. FDA provided authorization to proceed for our Innovate Phase 3 segment of our COVID-19 vaccine candidate, INO4800, in the U.S. Inovio now has the opportunity for the U.S. participants to potentially contribute to enrollment in our Innovate Phase 3 segment. The FDA has lifted a partial clinical hold following its review of additional non-clinical, clinical, and device information provided by Inovio. As I stated in this morning's release, I would like to recognize and express my appreciation to all of my Inovio colleagues for their hard work throughout this process. Separate from our Innovate Phase 3 trial, the World Health Organization shared on October 26 that INO4800 is one of the two vaccine candidates to be initially included in the Solidarity Trial Vaccines, which is an international randomized controlled phase three efficacy trial sponsored, funded, and conducted by the WHO. Per the WHO, Solidarity Trial Vaccines is designed to rapidly evaluate the efficacy and safety of promising new candidate vaccines selected by an independent vaccine prioritization advisory group composed of leading scientists and experts. They also shared that the trial has the additional potential to uncover second generation vaccines with greater efficacy, conferring greater protection against variants of concern, offering longer duration of protection, and or using needle-free routes of administration. With uncertainty about future outbreaks and much of the global community still requiring greater access to vaccines, we believe certain positive attributes of a DNA medicines platform like ours, and specifically INO4800, could aid public health measures against infectious diseases like COVID-19. INO4800 is well positioned to combat this global pandemic, having shown to be well tolerated to generate a balanced immune response that includes both cellular and humoral immune responses, and to offer a favorable thermal stability profile to facilitate global distribution. Additionally, Inovio's partner, a vaccine, is sponsoring a booster study in China where INO4800 is given as a booster after primary vaccination with an inactivated COVID-19 vaccine. Collectively, these trials are a testament to the attributes of INO4800 and its potential contribution globally as a primary vaccine series and as a booster, including for those who have received a primary series with other COVID-19 vaccines. Given the impending endemic nature of the virus transmission that underlies this global health crisis and the need for boosters to ensure sustained protection, DNA medicines may offer advantages compared to other approaches. This quarter, Inovio shared a positive data on homologous boosting from our phase one clinical trial as a preprint in MedArchive. The paper, which Dr. Anza Mamun will describe in further detail later in the call, found that INO4800 produced broad-based immune responses and was well tolerated as both a two-dose series and as a homologous booster in adults of all ages. Separately from our COVID-19 program, Inovio recently completed enrollment in our Lassa fever vaccine trial, which is funded by CEPI, or the Coalition for Epidemic Preparedness Innovations. These milestones collectively demonstrate the significant progress that Inovio continues to make across our DNA medicines platform against infectious diseases. With that, I'd like to turn the call now to Dr. Anza Mammon, our SVP of Clinical Development for COVID-19 Vaccine Program. Anza?