Arcturus Therapeutics Holdings Inc.

And welcome to Arcturus Therapeutic second quarter 2023 earnings call. At this time, all participants are in listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Neda Safarzadeh. Safar Zadeh, Vice President, Head of Investor Relations, Public Relations, and Marketing. Please go ahead.

Thank you, Operator. Good afternoon and welcome to Arcturus Therapeutics' second quarter 2023 financial update and pipeline progress call. Today's call will be led by Joseph Payne, our President and CEO, and Andy Sassine, our CFO. Dr. Pat Shivakula, our CSO and COO, will join them for the Q&A session. Before we begin, I would like to remind everyone that the statements made during this call regarding matters that are not historical facts are forward-looking statements within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees of performance. uncertainties, and assumptions that may cause actual results, performance, and achievements to differ materially from those expressed or implied by the statement. Please see the forward-looking statement disclaimer on the company's press release issued earlier today, as well as the risk factor section in our most recent form 10-K and in subsequent filings with the SEC. In addition, any forward-looking statements represent our view only as of the date such statements are made. Our service specifically disclaims any obligation to update such statements to reflect further information, events, or circumstances. And with that, I will now turn the call over to Joe.

Thank you, Nada. It's good to be with you again, everybody. We look forward to providing our updates today on our quarterly investor call. I will begin my remarks by highlighting our progress with our ARCT 154 COVID-19 vaccine phase three program. We're pleased with the rapid development and regulatory process progress recently made with our alliance partner Meiji Pharma toward the approval of ARCT 154 by the Japanese regulatory authorities. The ARCT154 submission is supported by an active controlled Phase 3 booster vaccine study that was executed during a period when multiple COVID variants were circulating. Initial ARCT154 Phase 3 booster study results were released as preprint last month in MedArchive. The study achieved its primary endpoint, demonstrating noninferiority of neutralizing antibody response against the SARS-CoV-2 ancestral strain when compared to Comirnaty. The study also demonstrated superiority of ARCT154 in neutralizing antibody response against the Omicron BA4-5 variant as a key secondary endpoint. The results of this trial indicate increased immunogenicity associated with ARCT154 at 28 days following booster administration. For the ancestral strain, the geometric mean ratio of neutralizing antibodies between ARCT154 and Comirnaty was 1.43 fold, indicating elevated neutralizing antibodies against the vaccine strain versus the comparator. based on available phase three clinical data at the time of interim analysis. ARCT 154 continues to demonstrate a favorable safety and tolerability profile with no additional safety concerns identified. In today's earnings release, we also included new ARCT 154 phase one slash two clinical study data, which suggest a durable immune response up to one year following booster administration. Notably, neutralizing antibody levels remained greater than tenfold above baseline across a panel of variants including Omicron. During the one-year observation, and this is during the entire one-year observation period. In summary, ARCT154 has shown broad neutralizing capability against multiple variants of concern and has the potential to offer not only effective but also a longer lasting immune response that may suggest durable protection against COVID-19. We're very pleased with the ARCT154 clinical data and now believe that this next generation self-amplifying mRNA platform is meaningfully different than conventional currently approved mRNA vaccines. I will note that the ARCT154 dose is very much lower. In our head-to-head study, ARCT154 was dosed at only 5 micrograms. This is an 83.3% lower dose than Comirnaty and at least 90% lower than other approved mRNA vaccines. As previously reported in April, Meiji submitted a new drug application in Japan to support potential initial approval of ARCT 154 as a primary immunization vaccine. And in June, we were pleased to hear that Meiji filed the NDA for the booster and included the relevant data to support that booster application. The review process with the PMDA is ongoing, with Japanese NDA approval being our next targeted milestone. A positive PMDA decision would represent Arcturus' first product approval,