Joseph Payne
Analyst · Guggenheim. Your line is open. Please go ahead
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 has never been more clear. We are developing an mRNA-based COVID vaccine aimed to protect those closest to us, our families, our communities, here and abroad. This is our current focus, and we will be dedicating most of the time on this call to this vaccine program. We recently announced important and very encouraging positive preclinical seroconversion data for our self-replicating mRNA COVID vaccine candidate that we call LUNAR-COV19. 100% of animals were seroconverted on day 19 at a single 2-microgram dose. The study results showed that our self-transcribing and replicating or STARR 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-COV19 vaccine generated a robust antibody response at all doses, even while measuring at 1,000 to 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. If we can repeat this result in the clinic, a single-shot vaccine is a likely outcome. I’m stressing this because multiple countries and strategic partners and foundations have all communicated to Arcturus and us that a single-shot vaccine is important to them due to the logistical distribution and supply chain challenges related to multi-dose vaccines. And now, as I look at the list of investors on the call, I see there’s many new names and new folks to Arcturus, and 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-COV19 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 STARR 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, or HSA, 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 Catalent, and expect to have the capacity to produce hundreds of millions of doses of LUNAR-COV19 annually. Catalent’s scalable CGMP manufacturing capabilities can produce millions of doses of LUNAR-COV19 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 to – 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 RNA – messenger RNA medicines include a potential treatment for ornithine transcarbamylase or OTC deficiency, also named as ARCT-810. 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 nonfunctional or deficient OTC enzyme. And the dysfunctionality can often cause neurological damage and severe damage to the liver. While Arcturus recently announced the acceptance of two clinical trials for its flagship asset, ARCT-810, also known as LUNAR OTC, the company’s investigational new drug or IND application for a Phase 1b study in patients with OTC deficiency was allowed to proceed by the U.S. FDA, or Food and Drug Administration. And an additional clinical trial application, or CTA, for a Phase 1 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 13. I will now turn the call over to our chief development officer, Steve Hughes.