Hi Linda and A.J. Good afternoon. Thanks for taking the question. So, a couple questions actually. So, first, wanted to get a little more color or detail. Now, obviously, the answers will be predicated on what the FDA says, but how would you describe your wish-list or goal for what you hope to get out of your upcoming FDA meeting, where you said the primary goal is to present the OLE data? Are you looking to change the potential launch dynamic, have it potentially come to market earlier? I mean, what is the ultimate goal here?
Linda Marbán
Yes, I mean, our ultimate goal, Joe -- and first of all, it's great talking to you. I'm looking forward to seeing you in September. Our ultimate goal is to get CAP-1002 to market and to these DMD markets as quickly as possible.
As I said in my talk and I've been saying now for a few weeks' time is muscle what became very clear in the open label extension data is when they were off CAP-1002, they decline and as soon as they go back on CAP-1002, they get better. The placebo patients were on the steady course of decline similar to natural history for two straight years, the year on placebo and a year on gap and then as soon as they went on CAP-1002, the delay -- we saw the delay of the decline of the disease process by about 70%.
We think this data is extraordinary. We think it is representative of disease modifying activity. We're going strong to the FDA to show this data and we are excited to work with them to bring this to approval as quickly as we possibly can.
Joe Pantginis
And the muscle data certainly speak for itself in my belief, so I guess, I'll ask it in another way, as I'm thinking about it. So, with regard to the commercialization dynamic, so is there a potential I mean, let's just call it swing for the fences at this point with regard to does CAP-1002 have the potential to be on the market prior to the readout of HOPE-3? And when I say on the market, I mean, something like maybe a managed access program on a patient-by-patient basis based on the data you'd look to present?
Linda Marbán
Yes, so our goals right now are very focused, the building blocks are in place to get CAP-1002 ready for commercialization. That means meeting with the FDA regarding the CMC, making sure that we are BLA-ready, presenting the open label extension data to the FDA, getting their feedback, and then we'll decide our path forward there -- what's the best path forward.
The exciting thing with our regulatory designation of RMAT, we really got preferred access to FDA. So, they're going to work with us on this. And certainly everybody that we've shown the data to, is excited by it. And anecdotally, the patients are saying they're definitely feeling and functioning better. And so they're going to stand up and say -- and sometimes even shout the same thing.
So, certainly, we've put the team in place. We've got the manager there. And if anybody knows, I know I'm a big baseball fan, so swinging for the fences is not something I'm afraid to do.
Joe Pantginis
There you go. Okay. And then, I guess, with regard to either concomitant timing of the meeting or a separate meeting with regard to CMC, I'm glad you're, you're planning ahead with regard to your manufacturing, and supplementing out of San Diego lab, I'm glad you made those comments. How would you potentially project your needs beyond that from a manufacturing standpoint?
Linda Marbán
In terms of the manufacturing, we're working on that plan right now. We have the facility, as I just announced that we're building as part of our San Diego labs here, it is a relatively low cost option, which affords us a tremendous opportunity for not only getting this product ready for BLA, but also for commercial launch. We'll evaluate along with our partner NS, the need as it becomes more apparent. And we'll keep everybody updated on our plans for that as we move forward.
Joe Pantginis
Got it. And then just lastly, because obviously, the future has a lot of exosomes being discussed. So, you mentioned a couple things here and in your press release too, that you're going to be looking for some preclinical data, maybe get a little more visibility about what kind of things we might see without necessarily tipping your hand. And you said you also have a potential partner in candidate in the form of vaccine candidate, is that something apart from your COVID candidate that you've discussed previously?
Linda Marbán
Yes, it's sort of a twist on the COVID candidate. So, I can't really talk too much about it right now because we're really working very hard with our IP and legal teams to make sure we're protected on every level.
What I can tell you about this is it's going to be very exciting because it takes the exosomes, which you know we've been working on for a long time, we've standardized the manufacturing of such, so that they can be scaled up and manufactured in a way that will make them competitive with any lipid delivery system out there.
But we can put a targeting molecule on the outside, and we can put custom payloads on the inside. The current vaccine candidate is similar to a recombinant protein vaccine, so -- but has the advantage of being able to be made into other types of vaccine candidates very quickly. So, we use COVID, sort of, as our model system, rapidly available and something that we've been working on for a while, but in reality, could be translated to any infectious disease or other types of utility, where a protein-based vaccine might be necessary or desired.
Joe Pantginis
Got it. And my last question, if you don't mind and it's actually kind of important, I think just based on the current biotech environment, which looks like it's starting to bounce back, but cash is king right now. So, being able to have a balance into the second quarter of 2024 speaks volumes. So, I wanted to address one of your comments in the press release and A.J.'s comments about excluding potential strategic uses of this capital, is this something that would look to expand your pipeline externally -- from an external source or further expand an exosome program, or I guess what kind of things could we look at if that would be one of the options you consider?
Anthony Bergmann
Yes, Joe, happy to take a little bit of that question. I mean, obviously, we're being judicious with our cash spend. I think we have a nice runway into the second quarter, because we just articulated of 2024.
And really what we're prioritizing what our current mission is focused on CAP-1002 for DMD, and the exposome pipeline right now in a preclinical status. So, it's obviously out there, and we're considering all options, but we're going to do our best to effectively manage our burn rate moving forward.
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