and some of the patients who are seeing all those strengths. So that could be a big differentiating factor. And also, as you know, Stargardt impacts a lot of pediatric patients. And the current clinical trial they're conducting focuses on 12 plus. And our clinical trial focuses on three plus. So there are a lot of differentiators. So whenever we come for pricing, because of the differentiated disruptive technology platform we have, and obviously everybody will focus on safety All right, thank you. I appreciate the additional color.

Our next question comes from the line, if we have the item mechanic or genuity, please go ahead.

Hey guys, my congrats on all the progress as well. Just to keep going on the Stargardt discussion, Shankar, since you mentioned it, can you talk about a little bit more, I guess, around the TPP here and the potential to show kind of reversal of disease and improvement in visual acuity? Is that something that is reasonable to expect given the duration of follow-up in the ongoing Phase 2-3 study? And I guess if so, is there anything that was done in terms of entry criteria to maybe enrich for that outcome as far as patient baseline characteristics?

I will ask Dr. Ghani to talk a little bit about baseline characteristics, then I'll answer the other question. Go ahead. Thank you, Shankar.

Hi, Whitney. Yes, happy to answer. So, our population was definitely broader than other competitors. Just to highlight, first, we included, you know, patients from early to late stage Stargardt disease. That's number one. As Shankar just mentioned, too, we included subjects, you know, are younger than, you know, young adults. We included, you know, subjects, you know, three plus years of age. So, that's a very broad population. As you know, for Stargardt, The earlier the better, especially if it's a progressive retina degeneration disease. The lesion size we also included in our trial, the Phase 2-3 Guardian trial, was more broader than what we saw with others. And our lesion size can include smaller lesions and also larger lesions. So we have a broad spectrum, and that's also going to be aligned with our early, late-stage strategy for the disease. We already included some of the subjects in our Phase 2-3 trials. So we will be excited to see the data. In addition to the gene mutation, specifically, we include all the variants and all the other specific mutations included in the ABCA4-related retinopathy. So it includes surrogate and others as well. So this is also on the disease indication overall. Based on your point about the functional, I think, you know, this is going to be critical. So we saw from our Phase 1 data, that we just published at the Eye Nature earlier in the year, we saw a very clear structure, slowing in the structure of progression in those patients. And also we saw functional benefit in those patients. And as you remember, as you know, in Stargardt disease, The first target is to hold that progression, to stop, you know, losing more retinal structure and function, which we achieved in our prior trial. The second goal, which will be, you know, the upside here, you know, and the ultimate goal, to reverse, you know, that tide, try, you know, to improve on the progress or improve on the disease outcome. And we saw that in our phase one, two. We saw some of the patients did improve in visual function. The gain was Six letters close to one line between the treated versus the untreated eyes. So we felt also very excited about the functional gain in this patient population. So that's kind of where we think, you know, the big differentiation, the broader application of our molecule.

Whitney, just to clarify, the primary endpoint, because it's a one-year trial, it's not a two-year trial, it's still a lesion. Then there are secondary visual function we'll be monitoring. In addition to that, at the time of filing, we continue to monitor our early-stage phase one patients, and so we'll have long-term data in those patients, too.

Got it. Really helpful. And then just last question, and maybe, Rita, this one's for you. Can you help us understand how you're thinking about cash, given the exciting progress with the GA study and the ability to start that study in September, I think you said? If there is a need to kind of pull levers to extend cash runway further, how should we think about maybe the startup of GA versus commercial prep for RP or Stargard and just kind of how you guys are thinking about those different levers if needed? Thanks.

Yeah, thank you, Whitney. So first of all, I mean, our primary goal is to make sure that we are, you know, minimizing shareholder dilution, but evaluating opportunities in order to raise capital, just as you said, in order to bring these novel products to patients. So just first of all, we have cash runway into 2028. And so I just want to remind everyone of that, which gives us the confidence to execute our clinical state, our late stage products that we have, and then progress to BLA submission for both OCU 410 and OCU 410ST in 2027, with the potential to commercialize OCU 400 by the end of the year in 2027. We do have some additional levers that we can pull, one, We have the PRV for OCU410ST given the RPD designation that we have. And so, of course, we have the ability to sell that for somewhere between 100 to 200 even prior to approval. And that's something that we are evaluating. We also have various business development deals that we are looking at from a and many more. Thank you for joining us. if we decide to do so. So, again, you know, just looking at both non-dilutive as well as dilutive options in order to make sure that we are able to bring these amazing and novel products to patients as well as looking at maximizing shareholder value.

Very helpful. Thank you.

Our next question comes from the line of Charles Wallace with H.D. Wigwright. Please go ahead.

Hi, this is Charles from HC Wainwright. I'm for RK. Thanks for taking my question. Maybe a question on Armada 3 design. So it seems like based on the prior earnings call, the study has been a little bit resized. I think previously you said it would be about 300 patients, and now it's 237 patients. So I was just curious if this was something the FDA specifically asked for, or if this was something you proposed, and then also if the assumptions change based on effect size, variability, dropout, or the narrower lesion size compared to the Phase II.

Yeah, Dr. Vinit.

Thank you, Charles. Yes, so we had a discussion with the agency, the FDA, so all this being aligned and discussed. with the FDA. But to answer your questions specifically, it was based on all the sample size estimation and also the power calculation we did. So the estimate you are citing, the 300, was based on estimate. But when we saw the effect size based on our Armada 1, the Phase 1-2 trial, as we discussed today, we saw the 31% reduction in the medium dose, the optimal dose, which is the one we are taking forward. When we did our calculation based on that, We saw, you know, the 237 total population to be enrolled will give us 95% power in our pivotal trial. All these pieces have been discussed with the agency. Obviously, it's based on the rate of change, the slope analysis for the primary efficacy. So, the effect size, you know, based on what we saw from earlier trial was very positive and was strong enough that we end up, you know, with 237. Two to one randomization, as we mentioned earlier, 158 in the treatment arm and 79 in the control arm. So all this has been discussed and aligned. And as we announced today, we got the clearance from the FDA to initiate our phase three trial in the next few weeks.

Thank you. Very helpful. And then I guess for the rolling submission, so I think Originally, the guidance was to submit in the third quarter, and now I believe it's the first quarter after the limelight data. I guess my question is, what kind of changed between submitting the non-clinical module earlier compared to after the top-line data, the limelight?

Charles, I think from our perspective already, I think we're doing very well with our PPQs, as we've mentioned. A lot of gene therapy companies stuck with CMC. We're ahead of the game. We used to commercial scale lots in phase three. We completed our PPQs on time. We got non-clinical at PPQ or done, so we have CMC non-clinical ready to go. I mean, obviously, this is where we have to work with the agency when they're comfortable, and that's the timeline they gave us, and we're going to be fine with that. The reason is, I just want to clarify, it's good to have rolling submission that gives a head start for agency, okay? It's for their own benefit. And if they want to wait until next year, I mean, we are ready to file it as soon as the top line comes for the pre-BLA meeting. We may still give them a head start of maybe a month or two months before we drop the clinical section. So however, I just want to clarify, until the final BLA is completed with the clinical section, the PDUFA date, the accelerated clock of six months doesn't start. I just want to clarify that. So once again, this is a collaboration between the sponsor and the agency. In this case, of course, we respect their decision, whatever they are, because they have a lot of programs and a lot of workload. Whatever the reasons are, we are fine with it. I think we're ready from our perspective, and we'll work with them closely in a collaborative way. And whenever we have a top line, we'll be ready to file it. It doesn't change any filing clock as we mentioned before. Second quarter, complete the BLA filing. Anticipated approval in fourth quarter. Six months accelerated clock.

Very helpful. Thanks for taking both questions.

Once again, if you would like to ask a question, please press star followed by the number one on your telephone keypad. Our next question comes from the line of Robert Leboyer with Noble Capital Markets. Please go ahead.

Good morning and congratulations on the progress. Just to follow up on that last question, my understanding was that the BLA submission will be completed in early 2027 when the clinical module is filed. That's when you get the PDUFA date and the approval launches based on that. But you also have rolling submission and have the option of filing the CMC and the other non-clinical modules before that. Is that still your plan?

Yes. Yes, Robert, absolutely. Because based on agency's suggestion and recommendation, as soon as the top line comes out, we'll have a pre-BLA meeting. Right after that, we can file the two modules, non-clinical and CMC modules. So that will still give them a head start. then as soon as the clinical module is done, when you file it, the pre-do for date starts. So that's basically our plan is to file that in second quarter. So six months clock should be fourth quarter, approval clock.

Okay, terrific. Thank you for that.

And at this time, we have no further questions. I would like to turn the call back over to the oxygen team for closing remarks.

Thank you all for attending today's webcast. Really appreciate. All our investors, shareholders, patients, providers, thank you.

This concludes today's conference call. You may now disconnect. Have a good day.