I guess we can go ahead? All right, I guess since I can always stand behind the pulpit, might feel more like church, and that's fine. We all need a little more of that, probably. But, it's good to be with you. My name is Joe Payne. I'm the CEO of Arcturus, and some faces I recognize, a lot I don't. So if this is your first time, seeing Arcturus, great! I'm glad I could introduce the story or at least the company to you today. Arcturus Therapeutics is a messenger RNA medicines and vaccines company. We have technologies that are different, that are next generation, and look forward to talking a little bit about those technologies and their applications in our pipeline. We're based in San Diego. If you ever get the chance to come out to visit us, we're on Science Center Drive there. We have a few sites along that road. It's a, it's one of the hotbeds in, in San Diego that you're very well familiar with, but we have a couple hundred employees, and we have multiple strategic partners that support us in large part with much of our pipeline programs. CSL is working with us on our vaccine enterprise. Ultragenyx, we have a rare disease partnership with them. The CF Foundation helps fund our cystic fibrosis program, and we have a relationship with BARDA. If, heaven forbid, flu becomes a pandemic, one of these pigs or birds cough on the wrong person, becomes airborne, this is gonna be a very serious problem, and we have a good relationship for pandemic flu with BARDA. We have proprietary technologies, I mentioned. First of all, the STARR technology, self-transcribing and replicating RNA. When we say next-generation messenger RNA, that's what we mean. In the vaccine space, this is a much, much lower dose technology. We've recently had collected some great phase III comparative clinical data on this, and it's just one of the technologies that we have at Arcturus. Again, that's self-amplifying messenger RNA. It's three times larger than messenger RNA. It expresses not only the antigen, but it also expresses an enzyme that replicates the process. So instead of making the antigen for one to two days, we make it for one to two weeks, and that gives you a much more robust immune response, and we've shown that clinically. Our LUNAR delivery technology is something we're known for. This is a lipid nanoparticle that is, again, different from what everyone else is using. Most, if not all of you, have been injected with lipid nanoparticles and mRNA right now. What you may not appreciate is that, lipids typically do not degrade in the older technology. These glycerol-based lipids have a long residence time, and they take a while to clear. But the Arcturus technology is different. The cores of our lipids are thiocarbamates, for you chemists in here. Sulfur, oxygen, and nitrogen provides handles to break down. It's different. It's biodegradable, it's non-accumulating in a multiple-dose setting, and we've highly optimized this delivery technology for three different cell types: hepatocytes in the liver, myocytes in the arm for vaccine applications, and then through inhalation to access bronchial epithelial cells. Manufacturing know-how is a big deal in this business. Messenger RNA is not our grandparents' therapeutics, for sure. These are very large, single-stranded, highly negatively charged compounds that you need to package up like a ball of yarn in these nanospheres. So we have substantial know-how on how to make, purify, formulate these therapeutics on very large scale now, and this is a differentiator. Especially with self-amplifying mRNA, it's 3 times larger than conventional mRNA. The manufacturing know-how is probably the number one reason why we'd be considered the most advanced self-amplifying mRNA company because of this know-how around making, purifying, and formulating these very large messenger RNA molecules. So we take these technologies, and we put them into a pipeline. We have three franchises in the company. We have a vaccine enterprise, but we also have a liver and a lung enterprise. We have a flagship asset for our liver program called ornithine transcarbamylase deficiency. This is a rare liver disease of significant commercial opportunity for a company of our size, and presently, it's in phase II in Europe. And we intend to share some initial data from that trial later this year. And then we have a flagship asset in our respiratory franchise for cystic fibrosis. It's a more well-understood disease. There's 10,000 or 100,000 of these folks globally, and we've successfully completed a phase I trial recently in this program. That's, again, a big deal because no one has ever inhaled the LUNAR technology before. We found 32 subjects, volunteers willing to do so at four different doses, and thankfully, it was a seamless trial, and we've now transitioned into patients. We got approval to proceed into patients in a phase I-B trial in New Zealand, and 6-8 folks is what we're looking at recruiting there. So at our next quarterly call, we can provide an update of where we are with enrollment, which is our next upcoming milestone, phase I-B, to initiate enrollment there. The vaccine enterprise has been partnered to a large extent with CSL. We partnered COVID and flu, and you can see that represented here. We've completed 2 phase III trials now with our COVID franchise. This is, again, the self-amplifying mRNA, the next-generation technology with significant benefits over conventional mRNA. And the seasonal flu shot is behind that, and that's a very important program to CSL, because they're one of the big players in the flu market. I mentioned that we have the pandemic flu with BARDA that's preclinical, but ongoing. They gave us a few years of cash, a significant commitment. I want to talk about CSL a little bit because it's a very important partnership for us, and for those that are unaware of CSL, they're a very large Australian-based company. They have over $10 billion in annual revenue. One of their divisions is called CSL Seqirus, and CSL Seqirus is a world leader in the flu shot. Many of you may have already been injected with a CSL flu shot. You know how you go in, you don't know the brand? It's likely it was CSL, just so you're aware. And they revenue approximately $2 billion in annual revenue in the flu vaccine. So just an ideal partner to help us as we commercialize this program globally, the COVID program. The total deal was $4.5 billion. We got a $200 million upfront. That is a very large upfront for a San Diego biotech company. Usually, when you start getting upwards into that range, you start talking about M&A. So this was just a really meaningful deal. It extended our runway to three years. We have $1.3 billion in development milestones spread across five programs: COVID, flu, and three other respiratory infectious disease vaccines. We've already collected over $100 million in milestones, so we have approximately $1.2 billion left in development milestones there, and then $3 billion in commercial milestones. And on top of that, 40% profit sharing on the COVID franchise. Just an extraordinary pre-commercial opportunity for us right now to monetize this platform and help fuel and fund our therapeutics franchise, our internal therapeutics pipeline. We also get double-digit royalties on our flu, up to double-digit royalties on the flu program and three additional respiratory infectious disease vaccines. Meiji is another important partner I wanted to highlight. CSL is, of course, going to really directly help us in Europe and United Kingdom, U.S. But in Japan, the number one flu shot company there is Meiji. I don't know how many of you have heard of Meiji, but in Japan, it's everywhere. There's a Meiji University, there's a Meiji Stadium, there's Meiji Streets, Meiji Temple. It's everywhere there. Brand recognition is fantastic. We have the ideal partner to help commercialize this vaccine technology in Japan. Meiji Seika Pharma has $1.4 billion in U.S. sales, includes antibacterials and vaccines. So I mentioned they are very well known in Japan in the flu shot space. They received substantial monies from the Japanese government to do a phase III trial using our COVID vaccine in Japan. It was a phase III direct comparison trial with Comirnaty, the Pfizer vaccine. We entered into the CSL agreement in April 2023, or Meiji did. So I guess, in summary, in Japan, the key commercial driver there is gonna be Meiji, but CSL and Arcturus are engaged with Meiji there in Japan. Globally, it's just CSL and Arcturus outside of Japan. Another partnership, so that you're aware of, is ARCALIS. If you have not heard of Arcalis, it's a CDMO, a manufacturing site in Japan that makes drug substance and soon to make drug product for these mRNA therapeutics and vaccines. We have a 49% t equity stake in this. A reason why this is important for you to highlight is we received $115 million from the Japanese government to help fund... And that's the picture of the actual building. It's 78,000 sq ft, 5 floors, and has a lot of great state-of-the-art new equipment, and we're in the process of completing tech transfer with them so that they can be completely independent with respect to drug substance and drug product. And having manufacturing capability in domestically in Japan is a big deal. I know everyone here is very patriotic, I'm sure, but in Japan, I hate to say it, but they're more patriotic than the U.S. They like to buy Japanese in Japan, so this is gonna help us, we believe, commercially, by having a presence, not only manufacturing, but a commercial distribution presence in Japan. Here's the summary for the phase III clinical study update. Very, very meaningful, important data for us. This is the first direct comparison trial with the Pfizer vaccine. We showed that at 83% lower dose, of only a dose level of 5 micrograms, we achieved non-inferiority antibody response to Comirnaty. We provide a non-inferiority statistical analysis, and we achieved that endpoint. It looked very promising, so we looked at it and did a superior statistical analysis against Omicron, and we found even in this trial of just approximately 828 people, we established significance. So this technology is superior to Pfizer's technology, conventional mRNA. So I've been selling this technology for 10 years, you can imagine, and no longer... I don't have to sell it anymore. I can just look at the data and allow other people to sell you on stuff. Okay? So we're very happy on this primary and secondary endpoint. It means we increased antibodies. That's what people want. They want more antibodies. They want a broader spectrum of antibodies. They want a longer-lasting vaccine.... and they want less reactogenicity. When the dose is much lower, there's less lipids and less RNA injected, so of course, you'd expect to see an improved reactogenicity profile locally: less pain, less inflammation, swelling, redness, induration. So overall, very happy with the success of the trial. Meiji submitted the NDA to the Japanese PMDA for the primary, followed it up with the PMDA for booster use, and we've taken this data with CSL, and you should be aware that we've recently received validation for our marketing authorization in Europe. That's in 27 additional countries in Europe. So we have a meaningful milestone next quarter for a potential approval in Japan for this platform and approval in Europe as soon as possible in 2024. I mentioned the booster durability. We shared from our U.S. and Singapore trial. We've just some background here. You can have all these assays measuring NAbs. We've talked about neutralizing antibody titer levels for a while, for the last three years, but whenever there's a new variant, the assay that gets developed is exploratory. It's not validated, but then as that's aged and reconfirmed and repeated, it becomes validated. These are all the validated assays against the original Beta, Delta, and Omicron, and our vaccine lasts over a year in clinical trials. So this is a significant differentiator from conventional mRNA. So this may be a technology that doesn't need to be updated as frequently and may be a longer-lasting vaccine, and we're excited about this potential commercially, as you can appreciate, 'cause there's a couple of issues with conventional mRNA vaccines. Now, moving on to ARCT-810. This is our flagship asset for the liver franchise. This is a systemically administered, intravenously administered messenger RNA, and when you're injecting as messenger RNA systemically, the most important feature is delivery. All of the failures, in some respect or in complete respect, prior to this asset by the field, has been attributed to delivery. When these lipids do not degrade, when they do not clear from the body, if these lipids accumulate, in essence, that's very bad. The regulatory agencies will terminate these programs. So this isn't just an issue, this is a terminal issue if you have non-biodegradable lipids, and our lipids are novel. They're completely different from everyone else in the field. The trade name, again, is LUNAR. It's a proprietary, biodegradable, non-accumulating lipid, and it's also been highly optimized for each cell type. You may not be aware of this, but normally, when a new mRNA or any RNA company starts, they'll license in a delivery technology that's available. But it's usually a delivery technology that's good for small RNA, like siRNA or antisense, or it's a delivery technology that's good for muscles or good for hepatocytes. So when you're starting a new company, you have to optimize this technology for a specific cell type. If you do not do that, the likelihood of failure is very high. So these are highly optimized LUNAR technologies for each specific cell type. We screen a library, and we understand these cell types very well. So OTC, what's the— Why did we choose this? It's the most common, most lucrative urea cycle disorder, the most attractive commercial opportunity for us. The presence... Like, if the urea cycle is dysfunctional, ammonia levels rise, and ammonia is Windex for the non-chemists in here. Ammonia is a bad character, a bad actor, crosses the blood-brain barrier, and it does bad things. So you want to suppress ammonia, and this is something that the present standard of care understands. So what do you do if you have high ammonia? Well, you take what's called ammonia scavengers. You swallow all these pills and drink all this water, and it scavenges the ammonia, and it clears it from your system. So you have to urinate 10 times a day, take a bunch of pills, costs $hundreds and hundreds and hundreds of thousands, but it doesn't cure or functionally address your disease. All it does is soak up the ammonia. These ammonia scavengers have challenges sometimes dealing with spikes of ammonia. So if you eat the wrong food, eat the wrong protein, then you'll get a spike of ammonia, and the scavengers may suppress ammonia, but they don't prevent spikes of ammonia. So along comes a messenger RNA approach. This is ideal for this disease because a messenger RNA molecule will go into hepatocytes, these you know where the urea cycle resides, and it'll functionally or it'll replace the dysfunctional or missing enzyme. So we're in the business of replacing what's missing, what's dysfunctional. That's what mRNA does, and if we can do this, it'll be transformational. It'll be very disruptive. It won't be an incremental change. It'll be functionally curative. And you can genetically engineer mice with OTC deficiency, and this is an OTC deficient mouse model. The target, by the way, in human beings is 5%. It's now well established that if you have 5% normal OTC as a human being, you're functionally normal. You don't even know you have the disease. But it's a big difference if you have 0%. So, 5% is the threshold, and what we've shown preclinically is even super physiological amounts of OTC. So we've got great preclinical data, and again, we've shown strong supportive data in the periportal region of the liver. Not to get too technical here, but there's a lot of delivery technologies that don't access the periportal region of the liver. There's a pericentral portion, there's a central portion of the liver. It's got a lot of lobes, a lot of stuff happening in the liver. You got to access the periportal region of the liver, and we have shown that. So all this collective preclinical data is very promising. Where are we in humans? Well, we had a very successful phase I and phase I-B in healthy volunteers and actual patients, and we've showed that our lipid clears. That is a big deal in this business. That is why we're in phase II. That's why we got approval to proceed in phase II, because our lipid is no longer there. Our lipid nanoparticle, our LUNAR technology, is gone after 48 hours, and we've shown this in healthy volunteers and in patients. We've dosed it up to 0.5 mg per kg successfully without steroid co-treatment. That's a big deal, especially in this patient population. So very successful phase I and phase I-B trial, and dozens of people have received this therapeutic, and now we are in Europe, in the United Kingdom. Several countries in Europe, several sites are now helping recruit patients. It is a very hard, methodical process. If you're familiar with rare liver diseases, there's a lot of great rare liver disease companies out there. We're recruiting at a similar pace as them, but we look forward to sharing some data, hopefully, later this year. We are recruiting up to 24 subjects in two dose cohorts. We have each subject is going to be receiving six doses that are two weeks apart, so six biweekly doses, and we're looking at safety and tolerability in adults and adolescents, kids as well, or adolescents, and a secondary endpoint on pharmacokinetics and pharmacodynamic markers. So there's a lot of biomarkers associated with this disease. We already talked about ammonia earlier. We want to normalize that ammonia, lower the ammonia. That's an important biomarker. That's the bad actor. But there's orotic acid in the urine that you can measure. You can measure other amino acids, like glutamate, that are impacted by the urea cycle disorder or by the urea cycle. And then you can measure OTC itself. Taking all this data collectively, you can triangulate it and submit it to regulatory agencies, and hopefully we can provide a convincing case that this is a great therapeutic. But the first data we're hoping to share later this year. ARCT-032, this is our flagship asset for our lung franchise. Before I just jump in, I just want to remind everyone that there's a lot of biotech companies that you are evaluating that are binary. They have one great asset that's either going to work or not. Arcturus is different. We have three assets that are not assets only. They are flagships representing three separate and very exciting commercial opportunities. Enormous commercial opportunity in vaccines, but also in the liver, and of course, in the lung. If any of these work, we can backfill with other exciting commercial opportunities behind it. So our flagship asset for the lung is CF, cystic fibrosis. In this disease, there's approximately 100,000 people worldwide. These patients are suffering because they have a dysfunctional or missing CFTR. This is a transporter that's located inside bronchial epithelial cells. When this transporter is missing or it's dysfunctional, the salt balance in your lungs goes out of whack, becomes imbalanced, and when your salt is imbalanced in your lungs, you have phlegm and swelling. Undesired inflammation leads to fibrotic disease and cirrhosis and ultimately scarring, and you can no longer breathe, and you pass. So it's a very serious lung-centric disease. But all of these patients, many, many different types, but whether it's dysfunctional enzyme or missing completely, this is type one CF, they all would like the same thing, which is a normal functioning CFTR transporter like you and I, and you don't need very much of it. It's like a pinprick. You just need one per cell, is what key opinion leaders have been telling me. So it's just like you just need one of these guys that is functional in the cell to alleviate the pressure of the chloride ion current. So just a little dab will do you for this, so we're excited about the threshold that's required for a successful drug here. But it's a clear unmet medical need, especially with type one CF. I know there's a very successful company that is treating CFTR with CFTR modulators. So you can modulate a dysfunctional enzyme, or you can simply replace it with a brand-new one, and if you're type 1 CF, which is 10% of the population, they don't have any treatment. So where are we here? This is the ARCT-032 clinical update. We've completed a phase I study in a seamless manner. I mentioned that a little bit in the intro. 32 subjects have inhaled this technology, and not just the technology, but this therapeutic. Four different doses, four different dose levels, eight in each cohort, and thankfully, it was seamless and without significant issue. So we were able to receive approval to proceed into a phase I-B at the same location in New Zealand. So we're gonna recruit 6-8 CF patients, with now that we have this data of 32 subjects in hand, we are much more smart with respect to dosing. We could have had the opportunity to go direct into patients, but we thought it was more wise to go into, because this is a novel technology, no one's ever inhaled this delivery technology, so now we're much more guided and much more smart with respect to dosing. And we got approval to proceed with 2 doses. It's not a single dose trial, it's two administrations of our therapeutic in six to eight patients, and we expect to initiate that shortly, and we'll be able to provide an update of where we are in this process, later this year at our quarterly call. One thing that separates this technology from the others, 'cause there's been other attempts, guys, to inhale messenger RNA, and they failed. I'm gonna be honest. Now, why? Why did they fail? Because you were inhaling unmodified messenger RNA. Now that we've injected billions of people with messenger RNA, we're much smarter than that's not a path forward that's wise. So we properly modified this construct. Point number two, and this is kind of a secret, and I need to start bragging about this a little bit more. Arcturus has a really strong IP position with purification of mRNA. Ten years ago, when we started the company, everyone was hyper-focused on modifying mRNA. We thought that the mRNA was to be blamed for all the undesired immune responses, and we were wrong. It was the impurities in the mRNA. The double-stranded impurities were the bad actors, and so we invested a ton of money and a ton of years into purifying this, built up IP, even acquired more IP to bolt onto it. We have a very strong IP position on purifying mRNA. So why is that important? Well, instead of injecting a little tiny amount for a vaccine in your arm, imagine inhaling copious amounts of mRNA. If it's not pure, that's very bad, and so this is a significant improvement on purification. So we've hit it out of the park with modifying it properly, and now we've purified this messenger RNA. But the most important change is LUNAR. To date, everyone's been using older, decades-old technology. I don't want to criticize older technology 'cause I was associated with it, but, but, you can understand that it's older technology. We've made significant improvements on bronchial epithelial cell delivery. Our nanoparticles survive the nebulization process, survive sputum, and allow it to biodistribute and transfect bronchial epithelial cells, and that's just half the story. You now need to break out of the endosome, and if you think hepatocytes and myocytes are similar to bronchial epithelial cells, just do a couple little bit of Google searches, and you'll find out they're completely different, and we had to go through that enormous learning curve. So this is a highly optimized, and we got this to work not only in mice and rats, those are easy models, but also a CF ferret model. So this, in a CF ferret model, if you give a ferret cystic fibrosis, it develops phlegm in their lungs, which emulates the human condition. All the other animals don't do this. So it's a trick in the business that they do to show positive data in these other species. But in the CF ferret model, you can see, we've transfected in the trachea and the bronchus, the upper and lower levels of the lung, and very strong data. When we shared this data at the CF conference, there was spontaneous applause for 1-2,000 scientists. They've never seen this before. No one has this data. If they do, they haven't shared it. This is differentiating. It's because our stuff works, and now we've inhaled it in 32 subjects, and we know it's safe. So we're now transitioning into patients, and we look forward to giving people updates on this going forward. But this is an exciting program for us. It's just one of three real platform shots on goal, and... Oh, just to touch on, we have collected human data on, in terms of cells. We got donor cells from CF patients, so we have high expression levels of CFTR itself, and we've shown restoration of chloride activity as well. So, that's it. In summary, three platforms getting validated, a lot of near-term milestones. We look forward to having an exciting biotech-type year for Arcturus, and I'm glad I could share some of this story with you, and look forward to addressing any questions with you or, if you wanna meet with us, we're available in San Diego, or I'm sure we can try to fit you into our schedule, okay? Thanks for your time, everybody.