Inovio Pharmaceuticals, Inc.

Good afternoon and welcome to the Inovio second 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 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 Latone, Senior Director of Investor Relations. Please go ahead.

Thank you, operator. Good afternoon, and thank you for joining the Inovio second quarter 2021 earnings conference call. Joining me on today's call are Dr. Joseph Kim, President and CEO, Mr. Peter Key, CFO, Dr. Jackie Hsieh, Chief Operating Officer, Dr. Laurent Hemot, Chief Scientific Officer, Dr. Anza Mamet, 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 second quarter ended June 30th, 2021. We will discuss our COVID-19 vaccine development efforts that address both current and future variants of concern, as well as recent developments associated with the Novio's various therapeutic programs relating to our DNA medicine platform. Among our recent updates, we'll address this morning's press release pertaining to the Heterologus Prime Boost clinical trial in China, as well as our company's global phase three innovate trial for our COVID-19 DNA vaccine candidate, INO4800, with our partner at Vaccine. 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 of DNA medicine, which include clinical and regulatory development and timing of clinical data readouts, along with capital resources and strategic matters. All 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 and in writing today, including without limitation risks and uncertainties related to conducting clinical trials, compliance with applicable regulatory requirements, our dependence on collaborative partners, third party and the level of cost associated with discovery and business development activities to assist in potentially bringing our products to market. 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 would like to turn the call over to Inovio's President and CEO, Dr. Joseph Kim.

Thank you, Ben. Good afternoon, and thank you for taking the time to join us for today's call. With COVID-19 rates surging again globally and an increasing number of breakthrough infections, Inovio recognizes the need for additional safe and effective first-line vaccine, particularly those which could offer potential boosting capabilities to combat the spread of the virus and emerging variants, including the rapidly spreading Delta variant. As an organization, we are committed to realize the potential that DNA medicines offer, not only to address this present public health needs in response to the global pandemic, but more broadly across therapeutic areas. In the short time we have today, I want to spend most of our call reviewing Inovio's strategy to advance INO4800 as a vaccine to be used globally as both a first-line vaccine and potentially a booster to prevent COVID-19 by leveraging key advantages of INO4800 and Inovio's DNA medicines platform. Specifically, the key advantages of our DNA medicines platform include the ability to generate robust T-cells alongside neutralizing antibodies, which we believe will be crucial in mitigating against rising variants of concern. Our DNA medicines also have shown a favorable tolerability, transportability, and thermal stability profiles. These differentiators, which have been further validated through some of our recent publications and preprints, are widely acknowledged to be essential for ensuring that vaccines can be made accessible globally are key concerns of regulators, countries, and vaccine supply initiatives. This morning's announcement is a wonderful example of that. Inovio and our partner, Avaxine, received regulatory allowance in China for two clinical trials investigating heterologous boosting with INO4800. These trials, which are being done through trial-sponsored vaccine, working together with Sinovac, will evaluate the safety, tolerability, and immunogenicity of heterologous prime boost sequential immunizations using INO4800 and Coronavac, an inactivated COVID-19 vaccine developed by Sinovac and validated by the World Health Organization for emergency use. Both trials, which will be conducted in China, are anticipated to begin this fall and will involve healthy adult subjects 18 years of age or older. With the increased challenge of the highly contagious Delta variant and other variants of concerns around the world, our work with the vaccine and Sinovac is more important than ever. If approved, we believe INO4800 will be well positioned to serve the vaccine needs of the global community as both a primary and a booster vaccine due to its tolerability, balanced cross-reactive immune responses, and strong thermal stability profile that does not require cold or ultra-cold chain transport. Helping to enable these trials, Inovio, along with the vaccine and Sinovac, recently completed cross-prime boost preclinical animal tests that evaluated the immune-boosting abilities of INO4800 and Coronavac. Results demonstrated that the PrimeBoost strategy can stimulate high level of antigen-specific binding antibodies, neutralizing antibodies by both live virus neutralization assay and an ACE receptor blocking assay, as well as antigen-specific T cell immune responses. We're really excited to see the continued development of heterologous prime boost strategies for COVID-19 vaccines with different mechanisms of action, as this is likely to become an important component of real-world vaccine use and may provide an efficient solution that synergistically enhances the immunogenicities of vaccines. We believe this concept will be a key factor in fighting against the current increase in global COVID-19 cases and variants of concerns and expanding the potential market for INO4800. We're especially excited and proud to expand our partnership with the vaccine to explore heterologous prime boosting using INO4800 to potentially protect more people against COVID-19 by serving as a potentially safer and more immune-enhancing booster vaccine, not only to the inactivated vaccine, but perhaps with other viral vectors and mRNA vaccines. We look forward to sharing data from these trials in the future. Before we go further, I would like to reiterate Inovio's focus on starting and executing our global Innovate Phase 3 trials in countries outside the U.S. More specifically, our primary focus is getting this trial initiated next month to enroll healthy men and non-pregnant women 18 years and older across several countries, concentrating on Latin America, Asia, in addition to expanding the trial to Africa. As it relates to the United States, Inovio does not plan on enrolling any subjects in the U.S. for the Innovate Phase 3 trial. We will engage the FDA on a formal lifting of the partial clinical hold as a part of our long-term plan to pursue a BLA approval in the U.S. once INO4800 efficacy is demonstrated in the global Innovate Phase 3 trials. Returning to the changing COVID pandemic landscape, in the second quarter, the company released a preprint, as a preprint, results showing that INO4800 provided broad cross-reactive immune responses in humans against VOC. In particular, the study showed that the T cell responses generated by INO4800 vaccination were fully maintained against the alpha, beta, and gamma variants when compared to the T cell responses to the original wild-type strain. Subsequent to this published work, and something that Dr. Kate Broderick will discuss later, INO4800 vaccination was also found to maintain a similar level of T cell responses against the delta variant when compared to the T cell responses to the original wild-type strain, while it showed a similar level of reduced neutralizing antibody activity against the Delta variant by other vaccines. In parallel with INO4800, Novio is also developing a novel pan-COVID second-generation vaccine candidate, INO4802, which is specifically designed to protect against current and future variants of concern. INO4802 could potentially offer broad boosting capabilities in addition to an initial vaccination regimen with INO4800 and or other first-generation vaccines, including both adenovirus and mRNA-based platforms. Both INO4800 and INO4802 are able to be used as a primary vaccine as well as both homologous and heterologous boosting. With that, I'd like to turn the call now to Dr. Anza Mammon, who is leading our global phase 3 trial for INO4800, for an update on the progress. Anza?