Arcturus Therapeutics Holdings Inc.

Ladies and gentlemen, thank you for standing by, and welcome to the Arcturus Therapeutics Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during this session, you will need to press star 1 on your telephone. If you require any further assistance, please press star 0. I would now like to hand the conference over to your host today, Neda Safarzadeh, Head of Investor Relations. Ma'am, 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 risk and uncertainties for purposes of the safer 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, the planned initiation of clinical trials, The likelihood of success of the company's coronavirus COVID-19 vaccine candidate or other product candidates and the company's current and future cash and financial position are 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 statements are based on management's current expectations and involve risks and uncertainties, including those discussed under the heading risk factors in Arcturus' most recent annual report on Form 10-K filed on March 16, 2020 and in subsequent SEC filings. except as otherwise required by law. Arcturus disclaims any intention or obligation to update or revise any forward-looking statements which speak only as of the date they were made. I will now turn the call over to Joe.

Great. Thank you, Neda. Good afternoon to all on the call. It's good to be with you. Thank you for joining our quarterly call today. The impact of the COVID-19 pandemic has been felt by everyone at Arcturus. Our families, our healthcare providers, everyone on this call today knows intimately what I'm talking about. This is truly a historical chapter in the Arcturus story. Societies are highly focused on the COVID pandemic and their health is taking precedence. Arcturus is facing this pandemic head-on. Our role in the biopharma industry is We recently announced important and very encouraging positive preclinical seroconversion data for our self-replicating mRNA COVID vaccine candidate that we call Lunar-COV-19. 100% of animals were seroconverted on day 19 at a single two-microgram dose. The study results showed that our self-transcribing and replicating or STAR mRNA induced higher seroconversion relative to conventional mRNA at equivalent doses. and today we shared new data. The results at day 30 in our immunogenicity study demonstrated that the Lunar Cov-19 vaccine generated a robust antibody response at all doses, even while measuring at 1 to 2,000 dilution, a 2,000-fold dilution, including at the lowest dose, 0.2 micrograms. Now, based on these encouraging results, a single-shot low-dose vaccine is now a reasonable expectation Thank you for joining us. I think it's helpful to take a moment to remind everyone how the Arcturus vaccine is differentiated from all of the other vaccines. We use self-replicating mRNA, not conventional mRNA. We use our biodegradable lunar lipid-mediated delivery technology, which is differentiating. These technologies are combined, and the resulting vaccine product is readily manufacturable using our proprietary manufacturing processes, yielding a potential single-shot low-dose vaccine that is devoid of extraneous viral materials and adjuvants that you see in other vaccine approaches. And this vaccine exhibits 100% seroconversion and robust immunogenicity in preclinical studies. For these reasons, we feel that the Lunar CoV-19 vaccine has the potential to be a superior vaccine. Based on these preclinical data, the clinical starting dose is one microgram, a significantly low dose. At this dose, one kilogram of STAR mRNA would be equivalent to one billion doses. You can understand why this is potentially a big deal. Our immediate priority and focus are to initiate clinical trials this summer in Singapore under the guidance of the Health Sciences Authority and over time we plan to expand geographically into other countries across the world. We have increased our manufacturing capacity to meet the anticipated demand. We're very pleased to have recently entered into a manufacturing partnership with Catalan and expect to have the capacity to produce hundreds of millions of doses of Lunar COVID-19 annually. Catalan's scalable CGMP manufacturing capabilities can produce millions of doses of Lunar COVID-19 mRNA in 2020 this year, and potentially hundreds of millions of doses annually for worldwide use. Our conversations with media, investors, foundations, and government agencies here and abroad are continuing. Rights and access to Arcturus' vaccine candidate this year and stockpiling initiatives will allow these groups to be in a position to quickly distribute the Arcturus vaccine to their respective populations immediately if the vaccine gains the appropriate regulatory approval. Now, in addition to vaccines, the Arcturus platform is applicable to intravenously dosed messenger RNA therapeutics and inhaled messenger RNA therapeutics. The Arcturus' pipeline of messenger RNA medicines includes a potential treatment for ornithine transcarbamylase, or OTC deficiency, also named as ARCT810. OTC deficiency is a rare disease, but the most common urea cycle disorder. Patients who are afflicted with this disease have difficulty removing toxic waste products as proteins are digested. OTC deficiency is caused by mutations in the OTC gene, which leads to non-reactive Thank you for joining us. and an additional clinical trial application or CTA for a phase one study in healthy volunteers was approved by the New Zealand Medicines and Medical Devices Safety Authority or MedSafe. And moving on to Lunar CF, the CF program continues to progress and is still on track for selecting a development candidate this year. The company expects to file an IND application in 2021. Arcturus is presenting new preclinical data at the virtual ASGCT conference on May 13th. I will now turn the call over to our Chief Development Officer, Steve Hughes.