Inovio Pharmaceuticals, Inc.

Good afternoon and welcome to the Inovio Pharmaceuticals fourth 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 Mattone, Senior Director of Investor Relations. Please go ahead.

Thank you, operator. Good afternoon and thank you for joining the Inovio fourth quarter 2021 financial results 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. Lermont Hemo, Chief Scientific Officer, Mark Twyman, Chief Commercial Officer, Dr. Jeffrey Skolnick, 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 fourth quarter and full year ended December 31st, 2021, as well as provide an update on our efforts across our DNA medicines platform. We will address the status of Inovio's COVID-19 efforts, as well as enrollment and dosing milestones achieved across our other infectious disease and HPV-associated programs. Following prepared remarks, we will conduct 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 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. 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.innovio.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. Joseph Kim.

Thank you, Ben, and good afternoon. I appreciate everyone taking the time to join us today. The impact of the highly transmissible Omicron variant of SARS-CoV-2 over the past few months highlights the enduring threat of COVID-19, particularly the unpredictability of current and future variants of concern. The ongoing impact of COVID-19 reaffirms and underscores the continued public health need and ongoing challenge to improve access to both primary vaccines and boosters across the global community. Assessment to this challenge is the fact that while over 63% of the global population has received at least one vaccine dose, and a growing number have received boosters, in certain countries, first dose vaccination rates are still below 12%. There is clearly more work to be done. Since the emergence of Omicron as the predominant COVID-19 variant circulating in the globe in November, the expectation for vaccination has changed. The highly infectious nature of Omicron has meant that while vaccines currently available in the market may not directly prevent infections, they can significantly protect the vaccinated from severe disease, hospitalization, and ultimately death. In this regard, many experts believe that virus targeting T cell responses are thought to play an important role in protection against severe disease and death, and may be central to the durability of vaccine protection. Inovio observed full maintenance of T cell responses against the Omicron variant in clinical samples from INO4800 vaccinated individuals. The preservation of T cell responses continues to remain a consistent observation for INO4800 against the ancestral COVID-19 virus and across all variants of concerns tested to date, including Omicron. In response to the dominance of Omicron variant globally, and the persistence of cross-reactive T cell responses generated by INO4800 across all VOCs to date, we plan to seek regulatory approval to amend the primary endpoint for our Phase III INOVAID trial from prevention of all symptomatic disease to prevention of severe disease. We believe INO4800's ability to generate T cell responses could be critical in meeting the proposed amended primary endpoint. In addition, due to the emergence of Omicron, the Data Safety Monitoring Board of our annual 4800 program recommended that we pause the enrollment of new participants to update the informed consent form and investigator brochure to reflect the potential impact of Omicron on the trial. The DSMB stated that safety issues were not a factor in this recommendation, and dosing may continue for those participants who have already received their first dose. As a result of the DSMB recommendation, as well as our plan to seek approval to amend the trial's primary endpoint, we have paused enrollment of new participants for Innovate. Interim efficacy data from Innovate will therefore not be available in the first half of 2022 as previously expected. In addition, we're also evaluating the feasibility of an additional XUS heterologous boost trial for IN04800 as a booster in a non-inferiority clinical trial compared to previously approved viral vector and inactivated COVID-19 vaccines. This will complement the ongoing booster trials that are being conducted in China by our partner at Vaccine. Viral vector and inactivated COVID-19 vaccines have been the most widely administered vaccine types globally, particularly in low to middle income countries, accounting for more than half of all doses delivered worldwide. Currently, approved and authorized vaccines may not meet the global demand for boosters to address the waning protection, a need which some regulatory agencies are considering with respect to evaluating a clinical pathway for heterologous boost candidates in clinical trials. In addition to early data from independent studies that suggest a mix and match booster strategy of heterologous boosting may confer advantages over the homologous boosting approach, IN04800's key advantages as a DNA vaccine correspond well with desired features of a heterologous boost vaccine. These advantages include its observed T-cell immunity for disease protection, tolerability for re-administration, favorable thermal stability profile for global transport, storage, and distribution, and ease of construct design, allowing for timely scaling and manufacturing. We are also pleased to share that a vaccine has completed enrollment of his 200 participant homologous and 267 participant heterologous boost phase 1 slash 2 clinical trials. The trials are designed to evaluate the safety, tolerability, and immunogenicity of INO4800 as a homologous boost, where INO4800 was administered as the primary vaccine, and as heterologous boosts where inactivated vaccines were administered as the primary vaccine. We look forward to sharing additional updates as a vaccine progresses with the trial. And as we shared last quarter, the World Health Organization, or WHO, selected INO4800 to be tested in a large international randomized control phase three clinical trial the solidarity trial vaccines, which is ongoing and being funded, sponsored, and conducted by the WHO. We are truly proud that INO4800 is the only DNA vaccine selected for this trial. We believe INOVO can most effectively support the global community as COVID-19 shifts from pandemic stage to endemic stage, while leveraging the strength of our DNA medicines platform and deep experience combating infectious diseases. With that, I'll turn it over to Dr. Kate Broderick, our Senior Vice President of R&D and Co-Program Lead for COVID Program, who will provide further details regarding INO4800 and the Omicron variant as well as our continued progress across our other infectious disease programs. Kate?