Ocular Therapeutix, Inc. Price & Performance (OCUL)

During today's call, certain statements we will be making constitute forward looking statements under the Safe harbor provisions of the Private Securities Litigation Reform Act of 1995 Actual results may differ materially as a result of a variety of factors including risks and uncertainties identified in the Risk Factors section of our annual report on Form 10 ks and our other SEC filings With that, I'd like to hand the call over to Doctor. Praveen Dougal, to review our recent updates. Thank you, Bill. And thank you to everyone for joining us today. 2024 was a transformational year for Ocular Therapeutics. We sharpened our focus and embraced a single bold mission, to redefine the retina experience Today, disrupting the treatment paradigm in wet AMD is our top priority And we are executing with speed precision and confidence, to bring Xpaxly to patients who need a more sustainable and effective treatment option. Despite established and effective treatments for wet AMD, the burden of frequent dosing leads up to a forty percent of patients discontinuing treatment in the first year alone effectively allowing themselves go blind. Patients deserve better. And EXPaxly has the potential to become the standard of care by offering a long lasting flexible treatment option.

And wet AMD is just the beginning. With compelling early clinical results in non proliferative diabetic retinopathy and diabetic macular edema, We see a significant opportunity to expand into these and other highly prevalent retinal indications where millions of patients remain untreated This morning, we announced several exciting updates that enhance and accelerate our positioning us incredibly well as we move toward clinical data and a potential NDA submission. Let's get right to it. First, we recently received FDA approval for an amendment to our special protocol agreement for SOL-one that incorporates redosing in all patients at 52 and week seventy six We believe this amendment unlocks the potential for Xpact lead to secure an unprecedented six to twelve month dosing label in wet AMD showcasing what we believe to be best in class durability. The impact of this cannot be overstated. The most recent approvals in this indication in most patients, yet they have rapidly gained market share and generated With XPaxly, we're talking about a different orbit altogether. With the potential to extend durability by months. As part of this amendment, the thirty six week primary endpoint for SOL-one remains [indiscernible] But we're required to maintain masking until week fifty two to provide additional information on durability up to and to allow potential label permitting redosing at twelve months.

As a result, we now expect to report top line data in the first quarter of twenty twenty six. While this slightly shifts the timeline for SOL-one top line data, we believe the long term benefits of this strategy are tremendous and will be abundantly clear at the end of this call. Most importantly, this strategy should allow us to accelerate our timeline for a comprehensive regulatory submission for [indiscernible] As I will describe, Moreover, we expect the additional data for repeat dosing will provide valuable insights into EXPATCLI's extended durability potentially supporting even greater flexibility on the product label. SOL-one, a trial that many thought would never be enrolled completed randomization in December 2024 well ahead of expectations. With three forty four subjects randomized across more than 100 clinical sites in The U. S. And Argentina, Trial conduct is now our top Priority. We are thrilled to report that subject retention has been exceptional to date. And the vast majority of rescue treatments as we have reviewed on a mass basis remain in line with the pre specified criteria established in the SOL-one protocol. We have also optimized SOLAR our non inferiority study to align with the changes in SEL-one.

Because redosing is now incorporated in SOH1, and retention in the trial is exceptional to date We are reducing the size of solar for eight twenty five subjects to approximately five fifty five subjects randomized. While maintaining robust power of 90% to evaluate a primary endpoint base on our expectations of how EXPaxly will perform. So LAR was initially designed to include eight twenty five subjects to meet the minimum FDA requirements [indiscernible] an unrestricted label fully dosing. Now that subjects in SOL-one are also being redosed, we're afforded the flexibility to reduce the number of subjects in SOLAR. This reduction should accelerate the SOLAR timeline for reporting data. Enhance capital efficiency, and maintain the scientific rigor needed for regulatory approval. Remember that SOLAR is a non inferiority trial comparing its paclithe administered every twenty four weeks against two milligram of flibroset administered every eight weeks. The primary endpoint is the mean change in best corrected visual or BCBA at week fifty six and patients will be followed until week [indiscernible] Importantly, as per the protocol agreed to by the FDA, the non inferiority margin for the EXPaxly arm at the lower bound is minus 4.5 letters of mean BCVA when compared to two milligram of fliviraceted dose every eight weeks.

This is also in line with the FDA's draft guidance. Eight milligram of flibroset masking compared to arm with the exact same dosing frequency as the EXPaxali arm. [indiscernible] are strategically designed to ensure trial integrity and preserve clinical relevance.

These criteria are consistent with previous non inferiority studies and include a combination of vision loss, and OCT changes By aligning these standards, non inferiority trial rescue protocols We believe the SOLAR study remains well positioned to demonstrate and effectiveness in a repeat dosing setting SOLAR enrollment continues to be strong. We previously announced three eleven subjects enrolled across various stages of loading and randomization as of 01/10/2025. This momentum puts us in a great position to advance our registrational program efficiently and effectively. Here at Ocular, our clinical trial design strategy using the loading phase to select patients for randomization and thereby potentially derisking our patient populations has been a key differentiator We designed SOL1 and SOLAR to work together with each trial seeking to answer critical questions about XPAXLE's durability, repeatability, and flexibility. These studies were developed to be complementary and not redundant ensuring that together they provide a robust clinical dataset that could support both regulatory approval and commercial adoption. SolarOne is focused on durability evaluating whether a single dose of X Xpaxli can maintain vision for thirty six weeks compared to a single two milligram of flibroset injection. This study was designed to establish superiority and to set a new benchmark for long term efficacy in wet AMD treatment.

With the recent SPA amendment incorporating fifty two week and seventy six week redosing, SOL-one now also provides you important insights into extended treatment intervals and long term redosing potential. SOLAR on the other hand is designed to address more frequent repeat dosing and potential real world applicability. By comparing EXPaxLE every twenty four weeks, to two milligram of flobraset every eight weeks, So, Lar evaluates how EXPaxly performs relative to a common but burdensome treatment regimen. The study is structured to provide critical evidence supporting the feasibility of an every six month treatment paradigm. One that we believe is aligned to preferences of retinal specialists and that could dramatically reduce the burden of care for patients. And caregivers alike. [indiscernible] Both studies were thoughtfully aligned with regulatory guidance. So one supported by SPA and SOLAR validated by Tietz C written response received from the FDA in August 2024 along with a subsequent written response received from the FDA in December 2024. Importantly, neither study utilizes sham for masking. Adhering to the FDA's clear stance that sham can introduce bias expressed through the agency's written feedback and public comments. The FDA previously agreed that together SOL1 and SOLAR could constitute two adequate and well controlled trials to support a potential NDA and label for EXPaxlate in wet AMD.

Pending a successful outcome, we intend to submit our NDA after the SOLAR fifty six week primary endpoint is reached. By integrating these complementary approaches seeking to demonstrate both best in class durability in SOL-one and sustained repeat dosing in SOLAR we believe we are enhancing the potential for successful trials that support a differentiated commercially attractive label. The dual nature of these trials allow us to generate a comprehensive clinical dataset that has the potential to support a strong regulatory submission and a compelling value proposition for patients retina specialists, and Payers.

Beyond wet AMD, we see a tremendous in non proliferative diabetic retinopathy or NPDR and diabetic macular edema or DME. Diabetic retinopathy is the leading cause of blindness in the working age population in The U. S. Despite the availability of anti VEGF therapies, fewer than one percent of the six point three million NPDR patients in The U. S. Largely due to the burden of frequent injections. XBaxley has the potential to transform [indiscernible] Our proof of concept HELIOS trial demonstrated compelling results In this trial, we showed that a single EXPaxelI injection may prevent vision threatening complications for up to twelve months. Additionally, all patients in the EXPaxley arm that had DME saw improvement at week forty eight. So what does this mean? That means that I as a retina physician can say to a patient your risk with diabetic retinopathy of developing vision threatening complication year upon year is thirty percent to forty percent. However, if you come to see me just once or twice a year, much like you go to a dentist for teeth cleaning, I may be able to reduce that risk to almost zero. That is a powerful message. I'm happy to inform you today that we expect to receive FDA feedback on our clinical trial design for NPDR and DME in the first half of this year paving the way for our next steps in these important indications.

Following the receipt, of the FDA feedback, we look forward to sharing with you our clinical trial design for these underserved vision threatening indications. We continue to operate from a position of financial with a cash balance of $392,000,000 as December 31, 2024. We remain laser focused on execution of SolOne and Solar. Our disciplined and prudent approach [indiscernible] that we are well financed and believe we have sufficient cash to fund our planned operating expenses debt service obligations and capital expenditures into 2028 fully funding our registrational trials in wet AMD and leaving us well positioned to execute [indiscernible] our broader strategic objectives. Our current cash projections do not factor in the impact of clinical trial activities in NPDR and DME. As the scope of that program is dependent on FDA feedback. That said, and to be very clear we do not currently intend to raise additional capital this year, 2024 was a year of transformation for Ocular Therapeutics. And 2025 is shaping up to be even more impactful what differentiates us is not just the speed and intensity but also the precision and exceptionally high quality of our execution. In less than one year, we have built a world class team [indiscernible] a groundbreaking asset and executed a registrational program that puts us in a position of strength as we move toward top line data, and a potential regulatory submission and approval.

Today, we shared several updates designed to enhance and accelerate [indiscernible] Further derisking our path to approval. To summarize, first, the FDA approved an amendment to the SOL-one SPAA to incorporate redosing at weeks fifty two and seventy six [indiscernible] potential label flexibility to every six to twelve months. Second, due to the requirement to maintain masking, until redosing at fifty two weeks, We now expect top line data for SOL-one including the thirty six week primary endpoint will be released in the first quarter of twenty twenty six. Third, Soul One retention has been outstanding [indiscernible] And the vast majority of rescue treatments reviewed on a mass basis, have been in accordance with the pre specified criteria of the protocol. Fourth, as a result of our updated SOL-one strategy for redosing, SOLAR has been streamlined with a target randomization reduced from eight twenty five to five fifty five subjects This should accelerate the time to both SOLAR data and regulatory filings for EXPaxly and wet AMD all the while maintaining strong statistical power and of 90% based on our expectations of how Ex Paxly will perform. Fifth, the non injury margin was so large is set at 4.5 letters.

And standard rescue criteria have been pre specified to align with regulatory guidance. Sixth, enrollment has been excellent across both trials So one completed randomization ahead of schedule in December and we previously announced SOLAR enrollment of three eleven subjects across various stages of loading and randomization as of January 10, 2025. [indiscernible] XPAC's lease opportunity extends beyond wet AMD. And we expect FDA feedback on the clinical trial design for NPDR and DME in the first half of this year. And a Ocular Therapeutics is well financed and has cash runway into 2028 we do not intend to finance this year. We're maintaining strong capital efficiency as we advance toward key clinical readouts and a potential NDA submission in wet AMD. We are redefining the retina experience setting a new standard in treatment durability flexibility and long term outcomes. With strong execution, regulatory alignment and clinical momentum we're well positioned to become a leading retina company. Thank you for your time. And continued support Operator, we are now ready to take questions. Thank you. Our first question comes from the line of Tazeen Ahmad with Bank of America.

Hi guys. Good morning. Thanks for the updates. A couple of questions from me. Praveen, just given the fact that you provided about the continued strength of what you're seeing blinded in SLL1 in terms of patients staying in the study as well the redosing rates coming in as you would have expected, from your pre specified criteria. Can you give us a little bit more color about why you think it makes sense to make these changes, especially right now And then secondly, in terms of making Solara smaller study, just given the high demand that there has been clearly for patients to want to be in the study, can you talk about the reasons why it wouldn't make sense anymore to have a study of this size just to add a little bit more cushion to the data set that we're expecting? And then I have one follow-up. Thank you, Tasim. Good morning to you. And again, thank you for your question. What you've raised is a really important point and let me try and give a [indiscernible] speaks to the way we've designed our sole programs and I include both. These are complementary trials. And I dare say that this is revolutionary and I think really quite historic I think everyone in the world expected us to have sole one and Sole two, which really has been the tradition.

And every just about every trial that I know it's been the same trial done twice. The second trial certainly is good to get the product approved and confirm the first trial. But when you think about it, it's terribly inefficient because it really doesn't add any extra information whatsoever. Instead, what we've designed is two trials that are always to be taken together in our app information they provide. And this I think is a unique and I dare say a revolution and historic concept that will allow for efficiency both in terms of the logistics of the trials the commercial applicability of the product, as well as the regulatory pathway. The bottom line in what we announced today the bottom line is that we will potentially get EXPACSLE to patients faster and with a better label. So let me go through the sequence of events. Two things happened. The first is that the FDA approved our redosing SPAA amendment for SOL-one. At week fifty two, and fifty six. The second thing that happened is that we noted that the retention in SOAR-one was absolutely superb. Under masking, of course. So based on these two events, we're able to increase the efficiency of both studies.

In SOL-one, what we're able to do is to get information on the first year on the durability and flexibility of the drug. Because now we have information at month nine, which is the primary endpoint that remains unchanged, [indiscernible] at month 12. And in the second year with redosing, what we're able to do in SOL-one is to maximize the exposure of the drug to patients and satisfy many of the FDA's safety requirements. So immediately, SOV1 became a much more efficient clinical trial And with that in mind, we're able to pass down that efficiency to SOLAR, the way these trials were designed. So no longer did we need eight twenty five patients in SOLAR, we could maximize efficiency in terms of our resources as well as in terms of getting the filing to the FDA are reducing the size from eight twenty five patients to five fifty five patients, while maintaining the integrity of the statistics. The impact of this Is that we will potentially have a much better label a label that is a superiority label with flexibility of six months to twelve months. And the second impact equally important of course is that we will get to market potentially faster and more efficiently.

Than we were able to before. So both of those things terribly important in terms of the impact of what's happened today. What I want to note very importantly also that the primary endpoint remains unchanged. Remember, the primary endpoint of SOL-one is at nine months that remains unchanged. The statistics remain unchanged. Completely. What we added today what we announced today were completely added efficiency bonuses. These are complementary trials designed to work together and I believe they work together absolutely beautifully.

Okay. That's super helpful. And my one follow-up is that given that as you said, the primary endpoint stays the same, Can you give us a sense of what the FDA might be looking for from redosing now in SLL1?

Well, again, the redosing allows for us in the first year to look to get information regarding flexibility and durability. Of the drug. Now we'll have information at month nine. Again, that's the primary endpoint, which remains absolutely unchanged. But additionally, we'll also have information at month 12 regarding durability of the drug. So potentially there's flexibility in the label for month nine as well as month 12. And as I mentioned, with the redosing, in the second year, there's more exposure of the drug to the patients. Therefore, we'll have even more data in regards to safety The beauty of this is that when you think about the efficiency of SO1, with a single injection, the first year, we'll have information for month nine and month 12 with repeat dosing for the second year we'll have increased safety information with more exposure of the drug to patients. Okay.

Thank you for all the color. Thank you, Jasmine.

Our next question is from the line of Biren Amin with Piper Sandler. Please proceed with your questions. Yes. Hi, guys. Thanks for taking my question and congrats on all the updates. So maybe Praveen, let me just start with SOL-one. What was the rationale for dosing at week seventy six I understand the week fifty two dosing. I was trying to understand, I guess, the rationale for wheat seventy six. And then then second question is for SOL-one will all patients receive redosing at weeks fifty two and week seventy six regardless of the arm. Including the control arm and also will those patients with prior rescues receive redosing at weeks fifty two and week seventy six.

Barry, good morning and thank you for your question. The answer for the first one is very simple. We wanted to maximize again the exposure of the drug to patients to satisfy the the FDA safety requirements thus redosing at week fifty six at week fifty two, I'm sorry, week fifty two and week seventy six. With a study ending at week one hundred and four. The answer to your second question, yes, every patient will be redosed at week fifty two and at week seventy six. The redosing will occur with the same drug that the patient was randomized to regardless of rescue. That's very important. So the answer to your question is yes, everybody will be redosed. At week fifty two and week seventy six.

With the original drug that they were randomized to. Hope that answers your question.

Thank you, Barron. That's all. And I just had a follow-up. So on solar, as a result of these changes, you clearly reduced the size to five fifty five patients. Which I think was that primarily due to the safety data that you're generating from SOL-one because I think now you would have another one hundred and seventy two patients that are redosed with Xpaxli from SOL-one Whereas I think you reduced the need for the patients to be redosed with SOLAR by about one hundred and eight patients with indigestafiline arm. And Barry, again, thank you. You're exactly right.

Your explanation is exactly correct. What we did was we designed solar originally to have eight twenty five patients to satisfy the FDA safety requirements.

And with the redosing amendment that we were able to get from the FDA, We were able to satisfy the safety studies [indiscernible] with the ability to the number of patients from eight twenty five patients to five fifty five patients, while still maintaining the statistical significance. So your answer to your correct.

Got it. And then maybe one last question. I guess from a timeline standpoint, were these changes to SOL one and SOLAR underway or made when the Board constructed your performance base package on Ocular share price hitting I think there were four different targets between $15 and $30 guess I want to understand if these changes provide increased confidence on hitting those performance targets?

Yes. So, Biren, again, thank you very much for the question.

The answer and obviously, we have discussions with the FDA that are ongoing. And we want to keep those those discussions confidential. We don't discuss them publicly. As with my discussions with the Board. But suffice it to say that our confidence As a company, in the success of these trials are higher than ever. And certainly my confidence Ocular is higher than ever. And you'll see that everything in this company is aligned to make sure that we ensure the success of both trials. Thank you. [indiscernible] Thanks for taking my questions.

Absolutely.

The next questions are from the line of Colleen Kussey with Baird. Please proceed with your question.

Great. Thanks. Good morning and thanks for taking our questions. So for the just to maybe clarify, for the redosing of patients in SOL-one, is that just for the FDA safety requirement for redosing or do you need to show anything for efficacy in that protocol in the second year I have a follow-up. Coleen, good morning and thank you for your question. The answer is that it really is the safety requirement for the FDA. However, what it does allow us to do again is get information given this because remember, it's not just the matter taking the second year separately, but also taking the second year in regard to how it affects the first year. So So what it allows us to do is to get that extra information that we will now have not only at month nine, but also at month 12.

So it does allow for the flexibility that we hope to get in the label. Because we have additional information now at month 12 as well as month nine. But again, we will satisfy the safety requirements, but we will also gain additional information in the second year regarding redosing. So this is not a requirement for hitting the primary endpoint. I want to make that very, very clear. It's important to emphasize that nothing about the original primary endpoint changes.

The primary endpoint remains at month nine and the statistics remain the same This is added efficiency today.

Got it. That's helpful. Thank you. And then I know when you first shared the SOLAR trial design last summer, I think it was a forty eight week endpoint and then that was prior to talking to the FDA. Now you're talking about a fifty six week endpoint. So can you just talk about what drove that change and that means for your dosing schedule, which I believe exactly is still going to be dose every twenty four weeks. So just kind of talk about that fifty six week endpoint, please. Yes. Thank you. Thank you, Collin. So you're exactly right. I think the first time you might have heard about the forty eight week endpoint for SOLAR was in our June Investor Day. And I want to emphasize, if you go back and check your notes then, we made it absolutely clear that we were proposing the solar clinical trial design at risk. And I think those two words at risk were mentioned quite a few times in that meeting. And the reason we did that is we made it very clear, very transparently that we had not yet gone to the FDA for formal approval regarding this trial design.

That's why it was at risk. [indiscernible] we did subsequently go to the FDA and the FDA came back and told us that they preferred a primary endpoint at week fifty two or [indiscernible] And as you know, we have a history of doing everything per the We wanted to make sure that we did it with the minimal amount of risk possible.

In fact, we didn't want to take any risk as far as our regulatory pathway is concerned. So then we decided given their preference to pick week 56 and the FDA has now accepted in writing our proposal to pick the primary endpoint for SOLAR at week 56. I hope that answers your question, Colleen.

Great.

Thanks. And last one, just any timelines for SOLAR recruitment now in decrease in the study size.

Yes. So Colleen, we did give an update at JPM as was said in my prepared statements. Since then, what I can tell you is that we've been thrilled with the recruitment of Solar and we will give you an update when appropriate, but it may be a little bit too early at this point. But thank you for your question.

Understood. Thanks for taking our questions.

Thank you. The next question is from the line of Kelly Shee with Jefferies.

Please proceed with your question.

This is Clara on for Kelly. Thanks for taking our question. Update. So you mentioned that you intend to submit NDA after 50 SIP week primary endpoints of SOLAR is reached.

So understand that the primary endpoints do not change, but also just trying to understand whether you would expect to have some long term redosing durability data in SOV1 as well by that time? And also just want to clarify whether the FDA requires that portion of data to support the redosing flexibility portion the label? Thank you. Clara, good morning and thank you for your question. Very important questions. And I want to make it very clear as to what the FDA requirements are for for NDA submission versus the information that we'll gather.

To be very, very clear, what the FDA requires for the NDA submission is hitting the primary endpoint in both studies. So Again, the primary endpoint for SOL-one at month nine remains the same. The primary endpoint for SOLAR is at week fifty six. And our intention is with presumably a positive study at week fifty six with SOLAR, we will submit the NDA application to the FDA. That is unchanged. We just expect given the announcements today that Ocular will be recruited with more efficiency given the fact that the sample size is smaller. Now in regards to your other questions, regarding other requirements, yes, the FDA does have safety requirements as you're aware. They will be fulfilled with the combination of patients in the second year in both SOL-one and SOLAR. In addition to that, we will also have a significant amount of information that we believe we can leverage for commercial success. And some of which you've already talked about and we've already talked about, which is the redosing of this drug that is now available both in SOL-one and in SOLAR. And remember, we also [indiscernible] third arm in SOLAR which compares this drug to high dose EYLEA.

Now that is not for statistical analysis, that's for numeric analysis. But you can imagine we will have between these two studies a significant amount of data that is not necessarily required by the FDA.

Certainly, it's not required for approval or NDA submission, but we can leverage for our commercial advantage and we do intend to do that.

Thank you The next question is from the line of Sean McCutchen with Raymond James.

Please proceed with your questions.

Hi, guys. Thanks for taking the question. So for SolR, could you give us some detail on on what you think the FDA expectations are, what your expectations are for what would be an acceptable number of rescues and timing of rescues regardless if you hit the non inferior or land within the non inferiority margin?

Thanks.

Sean, good morning and thank you for your question. Your question is a very important question, of course. So let me discuss rescues. We mentioned today, I just want clear that the non inventory margin was 4.5 letters. And I just want to emphasize that, that is because we're exact FDA.

We've always done that and we we expect to do that with everything that we do in regards to study design. In regards to the rescue, rescues, we have not detailed the rescue criteria as yet. For competitive reasons, but we will do so. But here's what I can tell you. We will detail those when appropriate.

You can expect the rescue criteria to be of no surprise. They will be absolutely in line with traditional rescue criteria that you've seen in the past.

The FDA has given very clear guidelines what they think about rescues, not just for us, but for all studies. The FDA has clearly stated and this was stated most recently by Doctor. Boyd in the American Academy of Ophthalmology meeting, that the first rescue in a non inferiority study will be allowed as long as it doesn't affect the primary endpoint. And the primary and that is a period of approximately three months or so as a rule of thumb before the primary endpoint. All other rescues will be subject to review. And again, that's been stated for a number of years now that is no different than any other clinical trial that still stands.

However, what I can tell you is that I believe we will have a huge advantage due to the design of our clinical trials. Remember these are complementary clinical trials and remember that SOLAR will never be reviewed by any Ocular agency without a positive SOL-one study. And when these rescues for solar are being evaluated, it will be evaluated in the context of a positive SOL-one study. So the regulatory agencies will have a very clear idea that this drug [indiscernible] last for nine to twelve months based on a positive SOL-one result. So again, the rescues will be reviewed in context of a positive SOL-one study, which will define the durability of this drug, which I will think will be very much to our advantage. Again, this also emphasizes the advantage that we have of having these two complementary studies Thanks for your question, Sean.

Thank you. Our next questions are from the line of John Wolden with Citizens JMP. Please proceed with your question.

Hey, thanks for taking the questions Praveen. Two from us. Can you discuss the change in powering for solar now for the primary And then stepping back, it seems like these changes have two big implications. One is the accelerate potential timing to a filing, but then also the new label information. But how do you think about the importance of those two Because my expectation would be, if you get a year on the label, docs could treat Xtend as they do anyway. So how much value is that fifty two weeks in the label versus just getting to market quicker? John, good morning and thank you for your questions. Again, very important question. Look, as far as the Ocular powering is concerned, we haven't guided you to that publicly. But what I can tell you is nothing changes. We have the eight twenty five patients patient number to satisfy the FDA safety requirements. The powering and the statistics really do not change at all. We're able to reduce the size because of the redosing amendment that was approved by the FDA for [indiscernible] The statistics remain very robust and unchanged for us.

In regards to your second question regarding labeling, look, as a physician, I can tell you, as someone who has practiced for the last thirty years. The label becomes very important for several reasons. One is scientific. It gives you the scientific data of what this drug does, which would be very important to see. The opportunity is there in this study to find out the durability of this drug in a scientific manner. And that is very valuable information for physicians and for patients. And for payers alike. The second reason for the labeling is really for the payers. And it will give us a huge commercial advantage. So [indiscernible] Our goal strategically is to have the best label that the market has seen. A label that is a superiority label which will be the first and only of its kind potentially and one with a great deal of flexibility of dosing from six months to twelve months. Thanks for your question, John. Thanks, Kavit.

Our next questions are from the line of Yi Chen with H. C. Wainwright.

Please proceed with your question. Thank you for taking my question. With respect to the NPL or MTD, Once you get the FDA feedback on clinical trial design, how quickly do you anticipate to advance to those two indications into clinical trials. And do you intend to advance both indications concurrently?

Good morning. Again, thank you for your question. I'm glad you asked about MPDR and DME. And I'm glad that that you put those together because I think it's very important to emphasize that with the HELIO study, we have shown absolutely everything to you, which is every single eye of every single patient. And what you'll see there is Not only a remarkable result in non proliferative diabetic retinopathy, In fact, every single patient who had diabetic macular edema on entry of that study improved. And what you saw in the angiogenesis meeting is a remarkable presentation by Doctor. Ehlers where he showed that very clearly that these patients with fluid improved significantly after a single injection after forty eight weeks. And so our goal is to pursue not just NPDR, but also DME How the trial will be designed to you, we don't know yet. Because we will still meet with the FDA formally We committed to doing that in the first half of this calendar year. That has not changed. How quickly we will implement that depends on that meeting. So I can't But what I can say and what we did say is that we are financed very, very efficiently.

We are very disciplined in our financial expenditures. And our intent is to keep the projections the way they are, which is that we are financed into 2028 And at this point, we do not have any intention of requiring any additional funding this year and that remains. Thank you for your question, Yi.

Our next question is from the line of Greg Harrison with Scotiabank.

Please proceed with your question.

Hey, good morning and thanks for taking the question. Curious what your expectations are for the percentage of patients that could show durability to fifty two weeks without rescue in SOL-one and And to what extent do you think it could be used that way in practice?

Greg, good morning and thank you for your question. The data first of all, it's very, very valuable information. And we don't shy away from this at all because not only because it's very valuable, but we believe that we're going to win quite honestly. We believe that there are a number of patients that will go to fifty two weeks And this is based on The U. S. Study. In The U. S. Study with sixty percent of patients that went that long, with a single injection and that was in a nonenhanced patient population. As you know, in previous discussions, we've gone through how painstakingly and thoughtfully we have selected our patients in a bespoke manner for each study to derisk the patient selection and derisk the outcomes. And the sixty percent that I quote to you really is in a unselected non enriched patient population. So we're very confident of what we will show at week 12. Remember that there are drugs that are in the market now that are approved on label for a two week or so extension, some going to four months, with not very many patients that have actually crossed that threshold in their study.

So from our point of view, we're going to provide very valuable information here to physicians payers and patients alike and we have the opportunity to have the best in class label as well. Thank you, Greg, for your question. [indiscernible] Thank you.

This concludes our question and answer session. I'll now turn the call back to Doctor. Praveen Dougal for closing remarks.

Once again, I'd like to thank everyone for taking the time to join us on our call today. We look forward to updating you on our progress And if you have any follow-up questions, please reach out to Bill Slattery, our Vice President of Investor Relations. Have a great day everybody. Thank you.

This concludes today's conference. You may disconnect your lines at this time. And thank you [indiscernible]