Hello and good morning. Welcome to the Jefferies Global Healthcare Conference in New York. My name is Emily Baird. I'm with the Jefferies team, and it is my pleasure to introduce Joseph Payne from Arcturus Therapeutics, President and CEO. All right. Good to be with you everyone, and thanks to Jefferies for the invitation. I have the opportunity to provide an update today on what's been happening at Arcturus Therapeutics. We are a next generation messenger RNA medicines company. We're based in San Diego, have about 100 employees. If you're ever on Science Center Drive in the Torrey Pines, La Jolla area, feel free to come by and visit. During the pandemic, Arcturus used our technology to help vaccinate areas in Singapore and Vietnam and Japan, and we actually have an approved COVID vaccine called Kostaive that's now approved in 32 countries, including in Japan, the United Kingdom, and the European Union. We also have an ongoing relationship with BARDA here in the United States for bird flu, that's the H5N1 program, and the partnerships are listed there. Meiji helps us with distribution in Japan. We're preparing for that upcoming season. The reason why our technologies were utilized in the pandemic, because they are a next generation technology in the vaccine space called self-amplifying mRNA. We'll be talking about that shortly. On the therapeutics side, this is where the company was founded on and our direction going forward, our primary focus is on the therapeutics area. Now that messenger RNA has been well proven and everyone's very well familiar with it, you'll see from our flagship programs that we have a flagship liver disease program and a flagship lung disease program for intravenously dosed mRNA and for inhaled messenger RNA respectively, with a partnership with the CF Foundation for the inhaled program for CF. We are different from the others in the messenger RNA space, and this is the points of emphasis for those that are new to Arcturus, if they want to know how are we different from the other mRNA players. One is definitely a point of emphasis is the LUNAR delivery. This is a lipid nanoparticle technology that is chemically different. It is not one of the older carbon-based or glycerol-based technologies. For the chemists listening to this call or here, we use thiocarbamate cores. That means there's oxygen and sulfur and nitrogen and handles for the body to break these lipids down, and we've shown in multiple trials now in humans that our lipids biodegrade. They do not accumulate, and that's very important in the therapeutic space. Unlike the vaccine space, which is one injection once a year, the therapeutics area is a much larger volume administered on a regular basis. It's very important that you show that these lipids are biodegradable, and that's a point of differentiation for us. They're highly optimized for each of those areas of delivery. Just to comment on the number of types of cells in the body, there's about 200 different types for those that are unfamiliar, and we're very good at three of them, at delivering RNA to hepatocytes after an intravenous administration, to bronchial epithelial cells after an inhaled application of our technology. Of course, after an intramuscular injection to myocytes or muscle cells for vaccine applications. Another point of differentiation is our manufacturing know-how. There's an extraordinary amount of resources and time that go into these sophisticated therapeutics to scale them up, and we got that process accelerated during the pandemic. We are one of a small number of companies that can make messenger RNA on scale. Why am I emphasizing this? Because again, we're one of the leaders in the messenger RNA therapeutics, and if you're venturing into that space, you will need the ability to make these products on scale. The amount of material that's required for a therapeutic program is much, much higher than you would have for a vaccine application. Just to highlight that this is a point of differentiation, that we know how to do this, and we know how to do it reproducibly and reliably. Going on to a summary of just these flagship assets is on this pipeline slide where we have our lead respiratory program for cystic fibrosis. It is partnered with the CF Foundation. We have a great relationship with that group. They understand the community very well. They know where every single Class I CF patient is in the U.S. and Europe, and that is very helpful since our initial focus for this program is to address the unmet medical need for CF in these Class I CF patients. In that trial, if you see the milestone on the far right, we're presently in a 12-week phase II study that's an open label study that's ongoing. This is going to be a key study for us this year as an upcoming milestone there. For the hepatic program, we have a flagship liver program for ornithine transcarbamylase deficiency or OTC deficiency. Our next milestone there that we're guiding for is an end of phase II meeting or EOP2 meeting in the second half of this year. We are having a Type C meeting this month, just for everyone's reference. We go through that process, then we'll have a tighter guidance as to when in the second half this year we'll have that EOP2 meeting. That's all we're waiting for is just some additional clarity from the FDA, and then we'll be able to have a tighter understanding when that end of phase II meeting will be. Now a deeper dive into the CF program. This program has captured a lot of interest from Wall Street because it has an extraordinary commercial opportunity, and it's addressing very serious unmet medical need in the CF community. As a background, this is an inhaled messenger RNA therapeutic. We're in the business of building a new CFTR protein in the lung, and this is very important. The successful CF players out there's very successful companies in cystic fibrosis. They are in the business of modulating a broken transporter, fixing it, modulating it. CFTR modulators they're called. That is not what Arcturus does. Arcturus is different. We're in the business of building a brand-new CFTR, and we do it through expression by inhaling mRNA that accesses the bronchial epithelial cells and expresses or makes a new CFTR. This is going to be very important for Class I CF because these folks do not have any CFTR in their lungs. There's nothing there to modulate. We have established a strong safety track record so far. We've done dosing at 5 mg, 10 mg, and 15 mg. This is daily dosing over 28 days, not a couple of days. This is differentiating for those that are new to the story. I think it's important to stress that for decades, the field, the pharmaceutical field, has failed at accessing or inhaling messenger RNA to access bronchial epithelial cells. Even though the lung is a mega billion or even a trillion-dollar organ, this is an extremely important organ in the body for the pharmaceutical industry, the lung. There's been extraordinary challenges to inhale lipids, to inhale RNA. Here we are, we've overcome those challenges because of the differentiation in our technology, and we'll go into that a little bit more. Arcturus initiated this phase II, this recent 12-week study in the first quarter. We're enrolling up to 20 subjects over a period of 12 weeks. I remind people that the Cystic Fibrosis Foundation is our partner, and they've already committed $25 million to this. We have all the Rare Pediatric Disease Designations and Orphan Drug Designations in both U.S. and Europe for this program. If we're successful, I think that's something to emphasize as well. We have a Cystic Fibrosis background or market opportunity slide. There is more than 100,000 cystic fibrosis patients worldwide. Why we're emphasizing that is because if our technology works in Class I CF, then everyone will begin to consider inhaling our drug as well in the CF space because everyone will want a new CFTR in their lungs rather than modulated CFTR. I think there's a considerable franchise opportunity here. I emphasized the unmet medical need already. The LUNAR-CF, our CF drug, aims again to restore the CFTR function. By so doing, you can restore salt balance. What this protein does is it restores or it transports salt, and if it's missing or broken, then it results in undesired phlegm accumulation and sputum, and that results in fibrotic disease, scarring. The phlegm and the scarring eventually overcomes the patient, and they can no longer breathe. It's a very serious challenge that we're up against, but we look forward to sharing data here shortly. I want to emphasize Class I CF. There's about 10,000 of these Class I CF patients locally or globally. We have come to realize that in some areas in the world, there's a high prevalence, up to 40% even of Class I CF in certain areas of the world. Here in the U.S., it's approximately 10%-15%, and they are ineligible for CFTR modulators. Here's the clinical summary of ARCT-032. The phase I study was completed successfully in 32 subjects. We were very pleased to see this because I just recall that it's been a decades' long challenge to successfully inhale lipids and RNA in humans. It's been traditionally very difficult to establish tolerability or avoid toxicity. When we went through phase I successfully, we were feeling very good about that study. We transitioned to a phase Ib study in actual adults with CF. Folks with Class I CF were included in that study, seven subjects, and we determined that it was safe and tolerable there as well, and we collected safety tolerability and PK data over a couple of administrations and we said, "Let's advance this further into phase II, into a 28-day study and a dose response study." We looked at five mg and 10 mg and 15 mg, and all three of these cohorts were successful and that it was safe and well-tolerated. Again, this is daily administration at five mg, 10 mg, and 15 mg. Where we are presently is we're in this 12-week open label study, enrolling up to 20 people in the U.S. and abroad, and the objective, again, is to establish safety, tolerability, and efficacy, including two types of lung function. There's one measurement called FEV, where you can determine if before and after treatment if you can increase the volume as you exhale, or the volume of the amount of air that's exhaled. There's another assay called LCI. This is lung clearance index. This is also very important to understand. This is a newer assay or a newer measurement for lung function. This is in a situation where you fill the lungs with 100% oxygen, and then you track how long it takes to equilibrate the lungs into normal air, which is about 20% oxygen. That time to equilibration is measured, and it's more a passive measurement, and it's more objective. It's not as subjective as FEV. We're looking at both FEV and LCI in this ongoing study, and those are considered both approvable endpoints. One observation that we saw in our phase II study so far is we saw that our drug reduced mucus plugs and the number of mucus plugs, and this is important to us. After 28 days, we used high-resolution CT scans to analyze before and after treatment, and you can see the data here that four to six participants in our second cohort, we saw a noticeable reduction, a meaningful reduction, approximately 28% reduction in mucus plugs and a 33% reduction in mucus volume in the responders. This was very encouraging to us and the KOLs that were working with us, and of course, the patients and their families and the PIs in the study. Just a little bit more background on high-resolution CT scan imaging. You can see that this is an example of what an adult healthy lung looks like. If you look at a Class I CF lung, they have these mucus plugs that are highlighted in red that are problematic. You can see before and after of a couple patients here, that especially in the lower register, that you see a clearance or reduction of these mucus plugs after 28 days. This is very encouraging. We've never seen this type of data before. In the modulator space, they have shown this data after six months and nine months and a year. When we saw it after 28 days, we were encouraged by this. This is not an approvable endpoint, but nonetheless, you can imagine what the CF patient thinks when they see their lungs resolving and removing these mucus plugs. This is summarized, the data collected, it's generally safe and well-tolerated. That's a big one because that's been the primary challenge for the field for the last couple of decades, so that's a big point. The second is we saw meaningful trends of clinical activity with high-res CT scans after 28 days of treatment at 10 mg. The present cohort, which we call Cohort 4, we're enrolling up to 20, and it's a 10-mg dose, and it's open label, and so this is ongoing. We have communicated that we have a high level of confidence that we'll have the data later this year that's sufficient for us to make decisions pertaining to this program on what's next and how to advance this program further. On to LUNAR-OTC. This is the ornithine transcarbamylase program. It's a rare liver disease. We call it ARCT-810. This is the number one urea cycle disorder. In OTC deficiency, you are deficient in ornithine transcarbamylase. This is an enzyme in the periportal portion of the liver, and if it's deficient or missing, then ammonia levels rise, and that's Windex, for those that are unfamiliar. You do not want ammonia crossing the blood-brain barrier and doing irreversible damage and neurological damage. It's a very serious unmet medical need. It's an X-linked disorder, so the young boys with this disease have a poor diagnosis and outlook. A significant unmet medical need, especially in children and young males. The present standard of care are ammonia scavengers, and these ammonia scavengers may mop up the ammonia, but they do not take care of the glutamine. Now, why is glutamine important? Well, before the ammonia scavengers scavenge the ammonia, the body converts ammonia to glutamine, and glutamine doesn't get scavenged. It crosses the blood-brain barrier and converts to ammonia and causes brain fog and challenges. There's a lot of room for improvement in this area, and we believe that a functional cure with a messenger RNA molecule would be fantastic, where the messenger RNA expresses or makes a brand new enzyme, an ornithine transcarbamylase in the liver. We had a very successful phase I study in healthy volunteers. This is the clinical summary. We transitioned to a phase Ib study, again, successful up to 0.5 mg/kg with no severe adverse events. We established safety tolerability and biomarker correction and normalization in the United Kingdom and the European Union, and also in the United States in multiple phase II studies in stable adults. This is very promising. Right now we are preparing for that end of phase II meeting that I referred to in the introduction, and where we're going to be presenting the complete data set. We have presented an interim data cut previously, earlier this year. This is the interim data. If you look on the. This is glutamine normalization. Again, the body converts ammonia to glutamine before it's scavenged. This is a problem in the community, and they track glutamine and ammonia. You can see a very clear reduction of glutamine and into the normal region during the process of treatment. After treatment is suspended, the glutamine raises above normal again. We've also looked at mean relative ureagenesis function. This is a new assay that wasn't available years ago, where we track how well the urea cycle is functioning. We've seen statistically significant improvements there. This is the interim data cut. What we're providing to the FDA later this year is the complete study at 0.3 and 0.5 mg/kg. We're going to be providing them the data that they've requested in a manner that they would like to see it. We will include ammonia stability. We saw that ammonia remained stable and within normal range throughout the study, and that's an important set of data. Of course, re-emphasizing the safety and tolerability. We have shown over and over again that our nanoparticles biodegrade and clear during the study. After 48 hr, they're no longer measurable, the lipids. This is a significant differentiator and why we're gaining significant traction with this program, as the safety and tolerability is important for these types of therapeutics. Now, vaccines. We do have Kostaive, this COVID vaccine that's approved in 32 countries, and we've collected some exciting data in bird flu with the U.S. government or BARDA. The reason our vaccine is different than conventional mRNA is we use the next generation self-transcribing and replicating RNA or self-amplifying mRNA technology. This allows us to reduce the dose dramatically. Any of the challenges that you've read about or toxicology, a lot of that tox associated with mRNA vaccines is associated with the dose level. If you can reduce the dose level dramatically, then you should have an impact on the safety as well. You can see this low-dose technology, it's only five micrograms. The other conventional mRNA vaccines are much, much higher. You see that we went through a very rapid process starting in May 2020 to four years later. Now today, six years after we started the program, we're approved in 32 countries. On our corporate deck, we have all the references of multiple phase III studies where we directly compared our technology to conventional mRNA. It's published in "The Lancet." Some data summary here, you can see the red line. This is a logarithmic scale too, guys. This is much, much higher antibodies, a broader spectrum of antibodies, a longer lasting, longer durable vaccine. I've had the opportunity myself to get the vaccine in Japan where it's approved. I've had the experience of conventional mRNA COVID vaccines and self-amplifying mRNA vaccines. I can attest to the low-dose benefits. It packs much less of a punch from my personal experience. It's just a great technology. The United States is aware of this, so they wanted to explore self-amplifying mRNA vaccines in the bird flu in case this, God forbid, ever becomes a problem. Bird flu would be dramatically worse than COVID if this became an issue, if this became airborne. We entered into a relationship with BARDA, and we've collected some just really fantastic data showcasing self-amplifying mRNA. Just for your notes on the side, if bird flu ever mutates and becomes airborne, then I'd feel very confident that we'll be part of the solution there. Hopefully we won't be talking about that in the future. finally, just to summarize our board of directors, we brought on a couple new board members. Moncef Slaoui is our Chairman. He led Operation Warp Speed and was a significant leader at GSK for a long period of time. John Markels, he was the President of Merck Vaccines. They're relatively new to the board, so I just wanted to emphasize that. That's it. Any questions? I'll pause now. Well, if there any other questions, thank you for your time. I look forward to the one-on-one conversations with some new investors that are reaching out and some familiar faces. We'll talk to you guys later. Bye for now.