Arcturus Therapeutics Holdings Inc.

Greetings and welcome to the Arturus Therapeutics second quarter 2020 earnings call. During the presentation, all participants will be in a listen-only mode. Afterwards, we'll conduct a question-and-answer session, and at that time, if you have a question, you can press the one followed by the four on your telephone. If at any time to the conference you need to reach an operator, you can press star zero. And as a reminder, this conference is being recorded Monday, August 10, 2020. I'd now like to turn it over to Neda Safarzadeh, Head of Investor Relations, Public Relations, and Marketing. Please go ahead.

Thank you, operator, and good afternoon, everyone. We are joined today by Joseph Payne, President and CEO, Andy Sassine, CFO, Dr. Pat Chivukula, CSO and COO, and Dr. Steve Hughes, our Chief Development 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-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements other than the statements of historical facts included in this communication, including those regarding the IND application, the CTA approval, the strategy, future operations, the status of preclinical and clinical development programs, Thank you for joining us. as a result of many factors including without limitation and inability to develop and market product candidates, unexpected clinical results, and general market conditions that may prevent such achievements or performance. Such statements are based on management's current expectations and involve risks and uncertainties, including those discussed under the heading risk factors in Arcturus's annual report on Form 10-K for the fiscal year ended December 31, 2019, filed with the SEC on March 16, 2020, and in subsequent filings with or submissions to 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, Neda, and good afternoon to all. And thank you for joining ArcTurus' quarterly call today, which today also happens to be Andy Sassine's birthday, our CFO. So, wow, what a quarter today it's been. Arcturus has made tremendous recent corporate progress, highlighted by the progress of two clinical programs. ARCT 021, which is our COVID-19 star mRNA vaccine candidate, and ARCT 810, our OTC deficiency program. The company has matured into a clinical stage company focused on the development of infectious disease vaccines and significant opportunities within healthcare. Thank you so much for joining us. Our COVID-19 vaccine utilizes Arcturus' self-transcribing and replicating mRNA technology, which is trademarked as STARR. And the STAR mRNA is delivered with Arcturus' lipid-mediated delivery system called LUNAR, which is also a registered trademark. By combining these two technologies, we're developing an extraordinary potential vaccine product for this extraordinary pandemic. with our partner, Duke NUS Medical School. And these technologies, when combined and based on what we have seen in preclinical testing, may provide an improved safety and efficacy profile in the clinic. This clinical candidate has the potential to be an effective and well-tolerated vaccine with a highly differentiated profile characterized by a very low dose and a potential single-shot administration. We may observe a lowered incidence of ISRs or injection site reactions due to the anticipated low dose of ARCTO21. And we may observe improved efficacy and durability of the vaccine since we observed robust humoral and cellular immune responses in our preclinical studies, particularly with CD8 T cell induction. ARCTO21 is supported by a strong preclinical package We've demonstrated a robust cell-mediated immune response, including CD8 T cells and a balanced Th1, Th2 response following a single administration of ARCT O21. We have seen a strong antibody response resulting in potent virus neutralization at a very low vaccine dose, again, after just a single administration. Further, neutralizing antibody titers continue to increase out to 60 days after dosing. Our vaccine is beautifully simple, completely devoid of viruses. There's no viral vectors, no adjuvants or no co-adjuvants. The Phase 1-2 study of ARCTO21, which we're conducting in up to 108 healthy volunteer adults in collaboration with Duke-NUS Medical School, has initiated screening, and we anticipate dosing The first cohort imminently within the next few days. This study will evaluate safety and immune response of the vaccine in both young and older adults. We continue to advance our COVID vaccine manufacturing activities. We successfully completed the technology transfer processes and providing sufficient vaccine product to support our clinical studies. Our and many more. Israel is the second country, in addition to Singapore, to reserve supply of Arcturus' COVID-19 vaccine. Discussions with additional countries pertaining to stockpiling and supply agreements continue to progress. Now, moving on to ARCT 810. We continue to advance our Phase 1 ARCT 810 clinical study in healthy volunteers. ARCT 810 is being developed for ornithine transcarbanolase deficiency. It's a serious disease with limited treatment options. ARCT 810 utilizes Arcturus' lunar lipid-mediated delivery platform to deliver OTC messenger RNA to the liver. Thank you very much. is a program that's been supported by strong preclinical data and OTC deficiency murine models, demonstrating that dosing of lunar OTC results in robust ornithine transcarbamylase protein expression and activity, resulting in improvements in ureogenesis and plasma ammonia and increased survival. Our OTC program is now in the clinic, now two months into the Phase I study, and no infusion-related reactions have been observed. No steroid pretreatments have been required. So we are understandably excited about the progress being made for our flagship intravenously dosed mRNA therapeutic. Steve will provide more details pertaining to our clinical programs for both ARCT021 and ARCT810 later in this call. We've also recently initiated two new programs, Lunar Flu and Lunar CV, targeting influenza and cardiovascular disease, respectively. Influenza vaccines and familial hypercholesterolemia are significant commercial opportunities, and we believe our technology is ideally suited to address each condition. Driving our R&D engine certainly requires significant resources, and the company has been very successful in raising approximately 280 million in gross proceeds this year to enable us to advance our promising therapeutic programs and Andy will provide more detail in a few minutes. In addition to the progress we have made in our R&D pipeline, we have strengthened our leadership team and appointed Lance Kurata as our Chief Legal Officer. Lance is nationally recognized leader in corporate life sciences transactions Lance joins us from Mintz, where he was a partner in the corporate group and a member of the life sciences practice group. Lance is recognized across the life sciences legal profession as a leading biotechnology-focused attorney with transactional and intellectual property expertise. I'm certainly pleased to welcome him to the company. We have also added Dr. Kelly Lindert, who has agreed to lead our vaccine franchise. including our COVID-19 and influenza vaccine programs. We're thrilled to have her join our team. Dr. Lindert joins us from Moderna, and prior to that, she led the influenza vaccine development at Novartis. We expect the remainder of the year to be a very exciting period for Arcturus. We look forward to obtaining initial clinical data from our two development stage programs, ARCTO21 and ARCT810, I'll now pass the call to Steve to provide more detail on our ongoing clinical programs. Steve, on to you. You might be on mute.