Arcturus Therapeutics Holdings Inc.

will begin momentarily. We thank you for your patience and ask that you please remain on the line. Once again, please stand by. The conference call will begin momentarily. Greetings and welcome to the Arcturus Therapeutics first quarter conference call. During the presentation, all participants will be in a listen-only mode. Afterwards, we will conduct a question and answer session. At that time, if you have a question, please press the 1 or by the 4 on your telephone. If at any time during the conference you need to reach an operator, please press star zero. As a reminder, this conference is being recorded today, Monday, May 10th, 2021. And now I'd like to turn the conference over to Neta Safarzadeh, Head of Investor Relations, Public Relations, and Marketing of Arcturus. Please go ahead.

Thank you, operator, and good afternoon, everyone. We are joined today by Joseph Payne, President and CEO of Andy Sassin, CFO, Dr. Pat Chivukula, CSO and COO, and Dr. Steve Hughes, our Chief Medical Officer. Before we begin, I would like to remind everyone that except for statements of historical facts, the statements made by management and any responses to questions on this conference call constitute forward statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Secretary's Litigation Reform Act of 1995. Any statements other than the statements of historical facts included in this communication, including those regarding the status and results of clinical development programs, the planned initiation, design or completion of clinical trials, the likelihood of success of the company's coronavirus COVID-19 vaccine candidate or other product candidates, the company's future manufacturing and other operations, and the company's current and future cash and financial position or forward-looking statements. Actual results and performance could differ materially from those projected in any forward-looking statements as a result of many factors, including without limitation, an inability to develop and market product candidates, unexpected clinical results, and general market conditions that may prevent such achievements or performance. Such achievements are based on management's current expectations and involve risks and uncertainties, including those discussed under the heading risk factor in ARCTRES' most recent annual report on Form 10-K with the SEC and in other filings that ARCTRES makes with the SEC. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements which speak only as of the date they were made, whether as a result of new information, future events, or circumstances, or otherwise. Now it is my pleasure to pass the call to Joe Payne, President and CEO. Joe, please go ahead.

Hey, thank you, Netta. Good afternoon to all. Thank you for joining the Arcturus' quarterly call today. Arcturus is developing a next generation class of mRNA-based medicines and vaccines. We believe that our platform has potential promise to generate new vaccines and other transformative medicines that address the underlying molecular basis of many serious diseases. We have made tremendous progress advancing our pipeline led by ARCTO21, our vaccine candidate for COVID-19. I'll begin with an overview of our ARCTO21 program. ARCT 021 is a differentiated COVID-19 vaccine candidate based on a self-transcribing and replicating mRNA technology. We believe that our approach may provide meaningful advantages compared to currently available vaccines for COVID-19. First, by using self-amplifying mRNA technology, ARCT 021 is designed to promote a strong immune response followed by a single administration. we believe this single-shot dosing regimen would be highly favored compared to the two administration approaches employed with currently authorized mRNA vaccines for emergency use. Second, a fundamental benefit of mRNA-based vaccines is that these vaccines may be readily modified and updated as needed. We expect that this could be an important benefit if the rapidly growing number of SARS-CoV-2 viral variants circulating throughout the globe require vaccine modifications. Third, another important benefit of mRNA-based vaccines is their ability to be re-dosed if needed, potentially on a yearly basis. It is expected that long-term protection to COVID is likely to require periodic re-dosing. And our approach, which utilizes the lunar delivery technology, and not a viral vector to deliver the vaccine may be well suited to enable periodic or annual redosing. Our expectation is that billions of individuals across the globe may require ongoing vaccination to protect against COVID-19. Based on all the favorable properties we expect with our approach, we believe that over the coming years, ARCTO21 as a low dose lyophilized single shot vaccine has the potential to become a favored or preferred vaccine option in many regions of the world. We have continued to rapidly advance our clinical development program for ARCTO21. Our phase two study is now fully enrolled with 580 participants. We're pleased to see the continued growth of our safety database and the consistencies reading through as we have clinically evaluated our vaccine in Singapore, and now also with participants in the United States. The primary purpose of this Phase 2 study was to further evaluate the safety and immunogenicity of ARCT021. The study remains ongoing. We have had multiple interim analyses of the safety data that have been reviewed by the DSMB, and the study has been allowed to proceed with no changes to protocol. As Steve will discuss shortly, Our interim immunogenicity data from the study demonstrate a high seroconversion rate, again, in line with our expectations. Given the study is ongoing, we remain blinded to full trial data, and we look forward to collecting additional endpoint measures from the study, including neutralizing antibody and T cell data. Based on the highly promising initial data that we've obtained from our phase two study, as well as from our prior phase one slash two trial, we have made the decision to advance a single shot, low five microgram dose regimen into phase three development. We are now in negotiations with multiple regulatory authorities regarding the specific design of this study. We are excited to move our ARCTO21 program into phase three, and we look forward to providing further updates on our progress in the near future. I'll now turn the time over to Dr. Steve Hughes, the Chief Medical Officer of Arcturus.