Well, welcome. Normally we would, you know, have someone to introduce us, but since it's just you guys, I might as well start out. I'm Andy Sassine, I'm the CFO of Arcturus Therapeutics, and we're delighted to be here to present to you. But the more important person is to my right, and I'll let him introduce himself and the opportunity here with our company.
My name is Joe Payne. I'm the CEO of Arcturus. It's good to be with you. Arcturus is a messenger RNA medicines and vaccines company. We're different from the others in the space in that we have exciting, new, and next-generation technologies that we are optimistic about. We think that can make a meaningful and impactful difference in the space. We have three franchises in the company. We've got a vaccine franchise, we've got a lung franchise, and a liver franchise, and each of these are led with flagship assets that represent each of these areas. We have a COVID vaccine that leads our vaccine enterprise that's been partnered with CSL, one of the leading vaccine players. Very fortunate to partner that with them. And we have a flagship asset in our liver program.
This is a messenger RNA therapeutic that treats ornithine transcarbamylase deficiency. This is a rare liver disease, the number one urea cycle disorder. And then we have a flagship asset in our lung enterprise. This is inhaled messenger RNA, and the indication there for the flagship is cystic fibrosis, and we're working with the CF Foundation on that program. And there's a lot of meaningful milestones that we're collecting in each of these programs. But I think it's helpful for us to start on the vaccine enterprise. We have a unique technology called self-amplifying messenger RNA. And recently, we have the first approval ever, the first approved self-amplifying mRNA product, so we're very happy about achieving that milestone as a company. The approval was in Japan by the PMDA and MHLW there.
So we're looking forward now to launching this product in Japan with our partners, Meiji and CSL. Meiji is driving the effort there in Japan. For those that are not familiar with who Meiji is, they're the number one flu shot company in Japan. So we have an ideal partner to help us with the launching and distributing the updated COVID vaccine later this year. And so that's a key objective for us. You can understand it's our first opportunity to establish revenues for the company. Very meaningful for a company of our size.
In addition to the launching activities in Japan with our partners, we're also looking to get approval in Europe, the U.K , and the U.S , and we're guiding that we're going to be getting approval for the COVID vaccine in Europe and U.K. later this year. So we're well on track to do that, and that's something we're looking forward to. In addition to the launch activities in Japan and the regulatory approval activities in Europe and U.K., we're also collecting very meaningful clinical data to support this platform on the vaccine side. What we've shown already is that our vaccine has performed very well.
We've collected very positive data and also superior data to show that our self-amplifying mRNA vaccine has been shown to be more immunogenic and longer lasting than the Pfizer vaccine, the Comirnaty. And we've shown this in a phase 3 direct comparison trial and published on this in The Lancet Infectious Diseases. So, just a real promising data there. We believe that higher antibodies and a longer-lasting vaccine with a broader spectrum of protection is preferred and desired, as well as another key feature of our self-amplifying mRNA technology is it's a very low dose level. Conventional mRNA vaccines are dosed at anywhere from 30-60 micrograms, and our dose level is only 5 microgram.
So any dose-related toxicology benefits, we're going to continue to collect safety data and the benefits of this lower dose technology.
Maybe I can give you guys a perspective on the CSL financial collaboration. It was a $200 million upfront deal, and they then got global rights to the COVID vaccine, the flu, as well as three other respiratory illnesses. And so, the total in terms of commercial and development milestones is over $4 billion. And to date, we've, you know, already almost gotten $400 million from them since, you know, we signed the contract a little over a year ago, and so very, you know, fast start. None of the financial guidance that we've given in terms of our cash runway would include any contribution from commercial milestones or revenues from our product, which is called Kostaive, and we'll be launching in Japan.
So we're funded for three years based on roughly $350 million in cash as of the last quarter. So, certainly a long enough runway to support multiple programs that are wholly owned by the company. I'll let-
We continue to collect clinical data, meaningful clinical data for the vaccine enterprise, not only in the monovalent area but the bivalent area. We have a bivalent Kostaive trial. Kostaive is the brand name of our product, compared to bivalent Comirnaty, and so that data is going to be coming out shortly. We also have an XBB monovalent trial ongoing in the Southern Hemisphere, so that's also of interest to mature the data set for the platform as we continuously go through the pipeline, the regulatory pipeline of getting approvals in Europe, U.K., and U.S. Beyond that, we have a flu program that we're working on with CSL. Our partnership with CSL includes not just COVID, but flu and some other respiratory infectious disease vaccines, and we have a flu shot trial ongoing in phase one.
This is a dose response, a DRF. We're looking at different dose levels in this trial. It's a quadrivalent vaccine that uses our LUNAR delivery technology and the self-amplifying mRNA technology as well. So we're going to be learning about how you know what's the maximum tolerated dose of this technology? And we'll be able to share that data later this year. So moving on to our therapeutics. You know, the general vision for this company is to access revenues and have some sort of commercial success with our partners, bring in those revenues to help fund for our therapeutic programs in the liver and lung space. And we have our OTC program.
This is ornithine transcarbamylase deficiency program has successfully completed a phase 1 and a phase 1b trial in the United States with patients, OTC patients, a single ascending dose trial. We're going to be presenting that phase 1b data next month in April at the SIMD conference in Charlotte, North Carolina. So we look forward to sharing that data. As well, we're collecting phase 2 proof-of-concept data throughout this year, and we aim to share some interim data on that as soon as we have it available. So that's a relatively near-term data set that we're excited to collect because that's the established proof of concept for our platform with intravenously dosed or systemically administered messenger RNA in a rare liver disease. Moving on to the CF program.
This is our flagship asset for inhaled messenger RNA. You can imagine, delivering RNA to bronchial epithelial cells has some significant challenges associated with this program. When you're inhaling messenger RNA, you have to make sure that not only the RNA, but the particles survive the aerosolization process. And so you need to... There's a learning curve in making and optimizing our delivery technology to survive the nebulization process, and then also the sputum or the phlegm in the lungs. The CF Foundation provided us some actual samples of human CF sputum, and we optimized our technology to survive the sputum. So normally, as nature does a pretty good job, the phlegm in our lungs destroys these particles pretty rapidly.
So we made a 10,000-fold improvement in the optimization process to make sure our particles survive the sputum, which allows these particles to distribute in the upper and lower lungs. We've collected very meaningful data with this program preclinically. We have some exciting data in ferrets. These are ferrets that have been engineered genetically to have cystic fibrosis. They get sick, they have copious amounts of phlegm in their lungs, so they're more representative, we believe, of the human condition. And so we've collected a meaningful preclinical data set that's unique to us. This is something that's differentiating. Very few folks have collected data in this model, and we have had a lot of success in the CF ferret model.
We entered in, we completed a phase 1 trial in our CF program successfully, 32 subjects, four dose levels, all healthy volunteers. Got very smart about our dosing paradigm, and we're safe and well tolerated in that study. We're going to be able to present more detail on that phase 1 data of 32 subjects in June in Europe at the CF conference there. So our team is looking forward to sharing more details about that phase 1 data set that's meaningful in 32 human subjects. The phase 1b trial, which is all patients, no placebo, that's ongoing. It's a small number of CF patients, approximately 6-8 patients are being recruited, and we're guiding that we're gonna be sharing some interim phase 1b data in the second quarter of this year. So that's a relatively near-term readout.
So a lot of clinical trial data that we're collecting, not only on the vaccine side, but also in our liver and lung programs, in flagship assets that are proving out the concept of this technology in very meaningful and commercially relevant cell types, hepatocyte in the liver and bronchial epithelial cells in the lung. So as you look at it, as we take a step back now and you look at it as a biotech investor, you see these potential big wins through this technology in the lung and liver that are coming here shortly. So relatively near-term milestones for this platform. At the same time, we have an approved product that we're working with our partners to launch this in Japan and subsequently in Europe, U.K., and U.S.
It provides that downside protection, of investing in a company with an approved product.
In our last conference call, we actually launched two additional vaccines to prevent Lyme disease and gonorrhea, and those are two pretty significant markets that, you know, certainly would, you know, be very well received, and certainly with our technology. So the platform is something that we feel is quite invaluable and could enable us to accelerate additional vaccines into the marketplace.
What's unique about Lyme disease and gonorrhea is these are bacteria-related infections, not viral like other programs we've worked on. So we continue to expand the scope of the platform for self-amplifying mRNA beyond just COVID. We think it has a lot of exciting potential. I think it's helpful to summarize. There's three aspects to self-amplifying mRNA that are interesting, that we're collecting the data on preclinically and clinically going forward. People are realizing that RNA vaccines in general are fast, so self-amplifying mRNA is a fast vaccine. That's very important for changing viruses. You want to make sure you have a fast technology that can be designed, manufactured, and distributed quickly. For non-changing viruses or changing viruses, it's important that we have durability.
And what we've shown already in a clinical trial, in a direct heads-up comparison with conventional mRNA, is that self-amplifying mRNA is a more durable vaccine, and we look forward to continuing to collect more data to support that statement, that it's a more durable technology. And finally, if we're working with viruses or bacterium that don't change very much, it's important that you have a technology that can be combined, right? If you look at all these infectious diseases where the bad guy doesn't change very much, it's important that you combine them into one vaccine. And that's where self-amplifying mRNA could play an exciting role in future combos as we build out this platform.
And the reason we're excited about that is because our dose level is so low, and we are, and to this day, we still don't know what the maximum tolerated dose for this technology is. So we're gonna continue to build this out, this concept of a technology that's fast, durable, and combinable, and this will set this technology apart from all other technologies in the vaccine space. So we're excited to continue to collect data to build that picture out for the platform. But that pretty much sums it up, Andy. I don't know if there's anything else you want to add on runway or?
Yeah, well, we covered that earlier, so we're in good shape there.
Okay.
We certainly would like to open it up if anyone has any questions. Hopefully, we've, you know, communicated the opportunity here and certainly excited about, you know, what's coming and we're on the verge of being commercial, so a little bit, you know, exciting from that standpoint. So I don't know if anyone has any specific questions, but feel free to either ask now or, you know, we're certainly available after this to speak individually if you prefer to do it in that manner. So go ahead.
Well, like a messenger RNA molecule can express an antigen, right? However, there's dose-limiting challenges with conventional mRNA. There's a lot of money invested in this in the pandemic. It really came in strong at 200 micrograms and 100 micrograms. We needed to reduce that, and we realized that around 50 micrograms approximately, is where it taps out. Self-amplifying mRNA is coming in at 5 micrograms, and at that dose level, we showed significant improvements over conventional mRNA. Multifold higher antibodies, a much broader spectrum of antibodies, much longer lasting, and we did it at 6-10 times lower dose. So because the dose level is so low and we still don't understand and/or appreciate the maximum tolerated dose, there's a lot of things we can do with self-amplifying mRNA.
We could express multiple antigens for a specific, like in flu, for example, it's a trivalent or a quadrivalent vaccine, where there's multiple antigens expressed in a vaccine. Or if you want to combine COVID with flu or RSV or other infectious diseases into one shot, the ability to bring things together and have multiple antigens in one shot, at least in theory, is there's more opportunity with self-amplifying mRNA, and we're going to continue to showcase that. And there's meaningful clinical data that's forthcoming very soon in the, with our bivalent study, where we're going to show in a multivalent setting, how do we compare to a multivalent or a bivalent conventional mRNA vaccine? So this is something that could be very interesting, as we, you know, grow the potential of the platform. Any other questions? All right.
Thank you.
I think we're good. Thanks for your time, everyone.