Clearside Biomedical at Needham Conference: Strategic Developments in Retinal Therapies

On Monday, 07 April 2025, Clearside Biomedical (NASDAQ: CLSD) presented at the 24th Annual Needham Virtual Healthcare Conference. The company highlighted significant progress in its retinal disease treatments using the suprachoroidal space (SCS) delivery platform. While Clearside reported a positive outlook on its product pipeline, financial sustainability remains a focus as it seeks funding for ongoing trials.

Key Takeaways

• Clearside's SCS platform is a promising method for retinal disease treatment, offering safety advantages.
• The company is advancing its CLS-AX product into Phase 3 trials for wet AMD.
• Financial sustainability is a concern, with cash reserves projected to last through Q4 2025.
• Strategic partnerships are crucial for funding and expanding Clearside's product reach.
• The company is exploring expansion into geographic atrophy treatments.

Financial Results

• Cash Position: Clearside ended the last year with $20 million in cash reserves, expected to last through Q4 2025.
• Funding Strategy: Actively exploring partnerships and financial arrangements to fund the Phase 3 trial of CLS-AX.
• Strategic Goal: Ensure the advancement of CLS-AX through Phase 3 to maximize asset value.

Operational Updates

• XIPERE Commercialization: Commercialized in the U.S. by Bausch and Lomb; approved in Australia and Singapore. Arctic Vision handles rights in China and Pan Asia.
• CLS-AX Development: Completed Phase 2b trials, Phase 3 ready. Focus on patient selection and redosing strategies for wet AMD.
• Geographic Atrophy Program: Preclinical program aimed at improving choroidal perfusion and addressing complement activation.
• SCS Platform: Over 15,000 injections performed, demonstrating safety and reliability.

Future Outlook

• CLS-AX Phase 3 Trials: Two trials planned with a non-inferiority design, targeting a 3-6 month dosing schedule. Enrollment expected to take 10-12 months.
• Geographic Atrophy Program: IND application filing planned, focusing on improving choroidal perfusion.
• Partnership Programs: Aura Biosciences, REGENXBIO/AbbVie, and BioCryst are progressing in their respective trials and regulatory processes.
• Regulatory Milestones: Awaiting approval for XIPERE in China and potential CLS-AX approvals based on Phase 3 outcomes.
• Commercial Strategy: CLS-AX aims to fit into the wet AMD treatment paradigm with flexible dosing.

Q&A Highlights

• Suprachoroidal Injection Technique: Easy for physicians to learn, supported by training programs.
• CLS-AX Dosing and Positioning: Expected to provide 3-6 months of efficacy, balancing patient convenience and treatment effectiveness.
• Geographic Atrophy Strategy: Focused on improving efficacy compared to existing therapies by enhancing choroidal perfusion.
• Patient Selection in Trials: Excluding patients with poor vision or thick retinas to improve trial reliability.

Readers are encouraged to refer to the full transcript for a more detailed understanding of Clearside Biomedical's strategic initiatives and developments.

Full transcript - 24th Annual Needham Virtual Healthcare Conference:

John Gianco, Member of the biotech, biopharma research team, Needham: Alright. Good afternoon, everyone, and welcome back to the twenty fourth Annual Needham Healthcare Conference. My name is John Gianco, and I'm a member of the biotech, biopharma research team here at Needham. So for our next session, I'm pleased to be joined by senior management of Clearside Biomedical, a late stage biopharma involved in treating retinal diseases via proprietary delivery platform. And just as a quick reminder for the audience, if you would like to ask any questions, you may do so via the webcast player, and we'll address them throughout our fireside chat today.

So with me is Clearside CEO, George Lazzakay, and CMO, Victor Chung. George and Victor, thank you very much for joining us.

George Lazzakay, CEO, Clearside Biomedical: Thank you, John, for having us, be part of the Needham conference. Appreciate it.

John Gianco, Member of the biotech, biopharma research team, Needham: Great. So, George, yeah, maybe we'll start with you, to kick things off with an overview of the company, and then we'll, jump into some questions.

George Lazzakay, CEO, Clearside Biomedical: Sure. Clearside has been focused on the delivery of drugs to the suprachoroidal space, which is a potential space behind the retina. We've been in focusing on that since early twenty sixteen. We've developed one product already that's been approved and is being marketed currently in The United States at XIPERE for Uveotic Macular Redeemer. We have a second product that has just completed Phase 2b.

There's a Phase three ready asset at CLS AX, a tyrosine kinase inhibitor for wet AMD also delivered to the suprachoroidal space. In addition, we've developed a number of partnerships, with other companies that have their therapeutics that they want to deliver to this space, REGENXBIO and AbbVie, with their RGX what used to be called RGX-three fourteen gene based therapy for wet AMD and diabetic retinopathy. Or Biosciences with their viral like gene drug conjugate for choroidal melanoma. They're also treating that in the suprachoroidal space. And our partner BioCryst that's developing a plasma kallikrein inhibitor for administration to the suprachoroidal space for the treatment of diabetic macular edema.

So those are our partnerships in the suprachoroidal space and our partnership with Bausch and Lomb and Arctic Vision for our first product XIPERE for uveitic macular edema. Bausch and Lomb is commercializing it in The United States and Arctic Vision has the rights, along with Santen Pharmaceuticals in Mainland China and the rest of Pan Asia. It's currently under review for approval in China. It's been approved in Australia and Singapore, and Santen is going to be the commercialization agent for the product in Mainland China upon approval. So, you know, we continue to work in the suprachoroidal area.

It's an area that's been increasingly of interest to retinal physicians and academics in terms of ways to administer drugs. And so we're working on it too. We have an early stage pipeline of geographic atrophy that we want to bring along and take into the clinic in the next few years. And so we really believe that the suprachoroidal space has a lot of potential for the treatment of a variety of retinal diseases, and we're proud to be a pioneer and a leader in that space.

John Gianco, Member of the biotech, biopharma research team, Needham: Great. Thanks so much, George. And, yeah, we'll we'll definitely get to the, your programs in in GA and, your partnerships as well later in the discussion. So, Victor, you know, you you came to Clearside last year with with a great deal of experience in this space. Just wanted to get your view on the use of suprachoroidal injections to treat back of the eye diseases.

And, you know, with that, you know, where do you think this modality kinda provides the most benefits for patients and physicians? And, maybe on on the other side of the coin, you know, what have been some of the the hurdles, Clearsides had to overcome as users and consumers get to know the product?

Victor Chung, CMO, Clearside Biomedical: Yeah. I think suprachoroidal space is slightly different, but not different enough that for any physician who want to learn to concern about it. So we do have a training program. And in fact, that as long as the physician willing to take a little time to think this is a little bit different. And our experience is after two or three injection that they will become they become expert already.

And we have a recent publication to suggest that that over 90% thought that was a easy procedure to perform. So in terms of benefit, it's like the way to think about the individual injection have been the norm and but they were injecting drug into a space that have no immune surveillance. So there's actually always a concern that, the bugs can allow to grow in that space and then cause endopharmitis even with this very small contamination. Luckily, that was actually quite rare. But if it happens, it is, you know, can easily blind the patient's eye.

So I think, again, that is as, you know, an important although rare event. And for shiver corroded, we don't go all the way. We injecting the drug in the in the coat of the eye, so as speak, that we don't don't fool. And also the corrode is next to that space. So you at least under the immune surveillance.

So there's really really a no risk of endomitis. And I think that is really a subtle but extremely important point for of the advantage. And I think that is a key comparing with intravitreal. And again, one additional advantage might be less relevant for wet AMD that our steroid product stay to the back of the eye. So they don't have any concern about cataract or high pressure because that when the drug is inside the eye, they can get to the lens, get to the serial body, and that caused those problem.

So I think that, you know, that is a lot of additional benefit over a, intravitreal injection.

John Gianco, Member of the biotech, biopharma research team, Needham: Great. Yeah. And so, as George mentioned, you know, you you you've had the approval and commercialization of of XIPERE for a bit now. You know, in your guys' perspective, you know, has this kinda made SES administration more mainstream, so to speak?

Victor Chung, CMO, Clearside Biomedical: I don't think it's necessary mainstream right now because uveitic macular edema is a very small indication. And indeed, that in the very beginning that Bush and Om and us have trained a lot of physician. But then, you know, when they don't use it and then they seem to lost interest, which we can understand why that, you know, like, even in my old practice, I may only have two or three a year. So it's quite hard to kinda, like, get good at it, you know, as such. So it's become more focused on the uveitis specialist.

And, again, the uveitis specialist would do a lot more, and that was where I was mentioning earlier. And and in a way that there is a bit of a boundary that those uveitis especially that are busy doing uveitis that don't tend to be doing the mainstream diabetic retinopathy and wet AMD. And then those like me who is focusing more on wet AMD and diabetic retinopathy don't do that much uveitis. However, that we believe that now that with Avi and Regenexx are moving to phase three program in diabetic retinopathy, and we are doing wet AMD. So then, you know, I think that in a few years time, that will become the mainstream.

And I think that, you know, when I remember that when I started doing Lucentis clinical trial as an investigator, intravitreal injection is not the mainstream. But now that if you don't do intravitreal injection, then you probably know a retro specialist focusing on common disease. So that is how we've felt that is, you know, like the interest is there, the technology the injection is not difficult. And therefore, that once the indication open up, you know, everyone will learn how to do that. Just like intravitreal injection, it was a scary thing when you all first started.

And this is not even scary because it's safer than intravitreal injection that we do thousands of them.

John Gianco, Member of the biotech, biopharma research team, Needham: Great. Understood. So switching gears now to your lead program, CLSAX, in wet AMD. You know, you recently unveiled the the phase three trial design. But first, you know, last year in October, you you guys read out the phase two b OHDICEY trial.

Maybe we can start there with the summary of the top line data as well as the subgroup analyses that you guys conducted and some of the learnings that you took when considering the design of those of the the phase threes? Yeah. So I think that

Victor Chung, CMO, Clearside Biomedical: we have chosen to do OUDCEA study on patient that who have did a lot of injection and still remain active. I think that we learned on some of the criticism at the time when some other TKI competitor are choosing patient that would need a lot of injection, but they could be not active anymore. And I think that some KOL have told us at the time that, well, you know, they might just have a lot of injection, but they don't need the injection. So therefore, it doesn't mean anything. So in our case that we deliberately chosen patient that who, who who are still active despite a large number of injection.

And then the second thing that we also do differently is, you know, we are redosing with our own drug. And other other company are focusing on rescuing and almost like testing how long the drug will last. But then redosing is the way that we think is important. And then that is why that we chose that even on our phase two, we can redose, for month three. And then but we then also that we redose everyone by month six.

I think that is a great learning for us that we know what happened when we're redosing our own drug. And again, we learned that, you know, by waiting until that the retina are pretty swollen and because that was the rescue criteria for someone other company. I think we we did learn that although we chose our, dosing slightly easy to redose, we still, to me, is it might be a little bit too late. And I think there's some of the KOI also comment on that. Those rescue criteria are rescuing a patient losing vision, and it should not be used in clinical practice.

So, again, we learn from our own data, but at the same time that, we were able to, adjust because we also know that when we're redosing our own drug, you know, what would happen. So those are key important. Now despite that, you know, we have, considering there's some deficit, deficiency, on our data, but the data look, on our not the data, on the design, but the data look still very good. You see that you still maintain the BCVA, maintain the vision, maintain the anatomy. So I think that it was despite that there were some, design issue in my book, but that is retrospective lens, you know, but I think that we learn through that.

So that is how that we thought about two or three things. Now first of all, that, you know, we think that our drug should be able to use for everyone. I think that was really important that, you know, we've we think that because since we can redose, then we don't need to look at those who only dry up completely, you know, and then then, you know, to potentially get to six months. And redosing in with our own drug is important. Another question then is, like, well, in our patient that who are redosing every every six months in our phase two study, have we been undertreating them?

So that was our first question. Because, you know, you might be undertreating someone purely because of that you just give them six months because they didn't meet your criteria. And again, we now subgroup analysis that we share in our Genesis that we have demonstrated that was not the case. In fact, that group do very, very well. So I think that was really a reassurance that every six months, you know, drug in a significant proportion of patient are completely doable.

And then the second thing that we discover that there will be some patient have very big visual acuity change and yet that there was no anatomy change. And again, KOL report to us to say that it's certainly also my clinical experience that in the clinic, they don't even look at the vision normally, partly because their vision is not very reliable. So again, then we actually look at another subclinical analysis just by eliminating some of these anomaly, and then we have even better result. So then again, in our phase three design that we would design it to optimize by re by really taking out some of those patient that we think that they might be unreliable and then to optimize our our study design. So those learning are very helpful that we know that when to redose and how to redose, and also that that we would be able to redose.

And furthermore, that, you know, by optimizing our study design, we will not expect any rescue whatsoever similar to EYLEA high dose and Vabismo in their phase three study, but we were just adjusting the dosing. And that is actually what physician do every day anyway. So I think that is what we believe that we have a clear differentiation from other TKI.

John Gianco, Member of the biotech, biopharma research team, Needham: Right. So again, you know, you have EYLEA and FABISMO currently on the market, you know, ranging from monthly dosing to every three to four months dosing. Again, maybe give a little bit more color on where CLS AX is gonna fit within that and then compare it back to the other TKIs in development as well.

Victor Chung, CMO, Clearside Biomedical: Yeah. So I think that when people talk about that abysmal have a one to four months dosing and so but in real world that a lot of kill told us that, you know, only a small number get to four months, you know, it does happen but not common. And I think that what we were thought thinking about it is that everyone in will get to three months in our drug at minimum, and then by majority will get to five to six months and some probably more than six months. So our flexible three to six month dosing is that, you know, we believe that CLAX, you know, can at least for three months for everyone. And then what most likely that is majority will expect will be twenty five or six month.

And indeed, some will probably go beyond six month, but we don't need a label to extend beyond six month. So I think that our three to six months label will make the most sense for physician, which is although, you know, it doesn't sound much comparing to the one to four month on my Bismol. However, that, you know, we believe that even a small extension, you know, make a, a compelling, commercial story. And I can see how well what Bismuth did, in the last couple of years. So we believe that this extension for another month or two, you know, to some people may not sound as much, but in the reality, that is a lot.

John Gianco, Member of the biotech, biopharma research team, Needham: Great. Yeah. And then so from a safety tolerability perspective in Odyssey, it was mostly pretty good, but, you know, there were a few occurrences of mild inflammation that resolved over time. Maybe can you provide just a little bit of color on these events and any mitigation strategies that you might be implementing moving forward?

Victor Chung, CMO, Clearside Biomedical: Yeah. So they so our reducing our our titer and our reporting for adverse event is also very tight. You know, I think that was something that we deliberately do and by giving the wrong impression. Those inflammatory information are really not an event. And some most of the other company would not even have reported them in the way that we did, but we have a full transparency to suggest that.

But we do learn that there was one or two cases that the procedure was not done correctly, and they were the first time ever for that physician to keep that procedure. And again, you know, now that in the very early part of the study, now that we have our partner doing a lot more training for their their gene therapy program, and we also done a lot more training on our own program. And I think those are no longer likely to be any issue when we move to phase three. Just like everything that phase two is a part of a learning. And so from our point of view, we learn and aware and then how to really make our phase three even more successful.

John Gianco, Member of the biotech, biopharma research team, Needham: Great. Understood. So, again, just last month, you know, you announced your official plans to for your two phase three trials for CLS AX, you know, which I believe has has some pretty interesting nuances that differentiate it from competitors in the space. Maybe provide just, know, an overview of the design and, you know, big picture, like, what, you know, do you want physicians and patients to take from these trials? So I think that the

Victor Chung, CMO, Clearside Biomedical: first things that we do is we went for a non inferiority design and that's a gold standard. And, again, any all the approval since idea, mean, Lucentis is the only one using superiority design when there was no good treatment. And since then, everything is non inferiority. So we believe non inferiority is the gold standard. We discussed with the agency and they also confirmed that that non inferiority tool, non inferiority study is the gold standard.

And then, you know, we start to return naive patient, but we are focusing on the maintenance phase. So everyone will be loaded with idea and which again, we believe that, you know, we might be able to load up our own drug, but again, we have never tested on the phase two or, you know, so we decided not to do that. But again, you know, in a way that the, you know, the maintenance market is actually the more important market, but also the way that I met with this, most of my patient wouldn't mind for the first few months to come every month. You know, it's only once they drag on that you need to come every two months for the rest of their life and that become a problem. So so I think that we believe that, you know, we don't wanna change that part of the loading part, so that's why that we keep that.

And then we basically that we then adjusting the dosing frequency, you know, a very similar to, Wabismol and Eylea high dose. Although the our, methodology are slightly tighter than them, I would say. That in other word that, you know, we can redose a little bit earlier, which is similar to what KOL have told us that in real life that they would redose much earlier or reducing the treatment extend period much earlier. So, again, you know, like, we are taking a lot of advice from that, and our study would, would be more real life, you know. And we're also, trying to separate, the so called intraretinal fluid and subretinal fluid, the different biomarker.

And, again, it's a condition that we always think intraretinal fluid is more important. And although because of that, then, you know, any recurrent of intraretinal fluid, then we would shorten the treatment interval. So I think those are the kind of key place that what it meant is that, you know, we have two non inferiority style, almost like reducing our regulatory risk. We are similar to recent approval, Eylea high dose, abysmal on the maintenance phase, and therefore also reduce our regulatory risk. And we don't expect rescue that is also reducing wreck regulatory risk because rescue could become a human failure, and the agency do concern about that.

And so I think those are the key point that, you know, that see how we want to how we get success. But we do also optimize our population that we take out people that we think that would be, you know, potential creating variability. And the non inferiority design, variability can cause problem and but because of that, that by reducing variability, then we can actually have a pop a study size more reasonable. And not only meeting the criteria for the agency, but we have a strong reason to believe that it will be linked to success because of all this optimization and and improvement on the design learned from previous approved product.

John Gianco, Member of the biotech, biopharma research team, Needham: Right. Yeah. So I I think, you know, the the overall design of the trial to reduce variability is one of the key aspects. You know, is there any anything specific, you know, from the enrollment criteria within this treatment naive population that might might have been different than other trials? And, you know, again, what's you know, using that treatment naive versus treatment experience, what are some of those differences there that you're trying to mitigate risk?

Victor Chung, CMO, Clearside Biomedical: Yeah. The treatment naive patient that we do exclude those patient who got poor vision and also those who had very thick retina. So I I was fortunate leading a study that when I in my academic career that we can we have looked at more than 2,000 or 2,000 eye, better than say that in The UK, when they were to give an idea how that behave called the precise study. And we have multiple publication on that. And, you know, what you guys have to think about it is that, you know, well, when you got poor vision, you have high variability because, you know, it's difficult to see how much improvement that you can get.

And also when you got fair thick retina that, you know, also that there's a variability. So we took them out and again, the agency said no problem with that because we really justify the reason we're taking them out is because that those are the patient that have high variability. And the agency understand that, you know, that that that is okay for us to do so. And then to reduce the in further variability is that once you have free injection of monthly idea, and then you usually have a gap of eight weeks between the third and the fourth injection. Again, not only from previous clinical trial, but also from our data that I mentioned in the PRECISE study.

During those two time point, you don't expect to have much change. So again, that, you know, if you have, like, 10 letter change, it means that the patient might not be able to do the test very well. Again, it's only very small percentage. We have looked at it, it might be only two or three percent, but that two or three percent creating a huge amount of variability. So so again, that we take them out for that reason.

And similarly, that we also take out as another few percent. There's something in between a third and fourth injection that I seem to got worse a lot. And again, that go to patient that is very uncommon, but yet that they might be, you know, are different. And for some reason that they might be just not appropriate, you know, for anti VEGF treatment. So I think that we chose those small adjustment taking out those patient.

And although it only take out a small percentage, but take out a massive chunk of variability.

John Gianco, Member of the biotech, biopharma research team, Needham: Great. Yeah. Understood. So then, you know, looking towards, you know, what your kind of bars of success are and, you know, how the trial is is powered, maybe you can touch on that a little bit. And, broadly speaking, if you could give any sort of rough timelines for, a clinical program of that's gonna be roughly 900 patients in terms of how long you would expect for the trial to enroll and then, time from initiation to trial readout broadly speaking.

Victor Chung, CMO, Clearside Biomedical: Of that. So I think that, you know, like like, all phase three trial, the most important, success is the primary endpoint on safety and efficacy is is met. I think it's as simple as that. You know, the agency won't be CVA, so it's very straightforward from that perspective. So also that because of that, you know, we knew about what you and I patient would behave, what the variability is.

And we're actually using a pretty standard variability, number that's similar to furosemab study. And but in fact, that we believe that our web video will probably be smaller because of the optimization. And in the in the webismo study that they didn't they didn't really consider optimization. So I think that was the kind of recent that, you know, 90%, you know, success and and so on. And the margin also differ is that I think in some of the for for this most study, they're using four letter.

And again, we assume the agency. The agency think that four and a half letter is the the gold standard now. So, again, you know, being four and a half letter that we we we're able to reducing our study size a little bit comparing with previous study. So those are, you know, discussed with the agency as well as the how that we optimize our study design to reducing our study size a little bit. And then in terms of recruitment, I think that, you know, we have seen that that recruiting treatment naive patient was not difficult.

I mean, it was very seem to be everyone doing it even faster than they expected. And again, we believe that will be the case as well for us. But in general, we talk about this roughly twelve month is is kind of like standard methodology, but we probably aim we probably aim for around ten ten to twelve months. And in terms of two primary, and as you remember that, you know, phase three design, we have been loading phase. So it's around about sixteen months from the last patient out.

So so that will be roughly what we would expect on the first primary readout. And don't forget that we do progress to year two for safety data, but if we but when we're doing two concurrent phase three data, the a phase three study that we only need a certain number of patient gets through to year two, and then we can already file. So you take you know, the filing time is just shorter than the full last patient out per se.

John Gianco, Member of the biotech, biopharma research team, Needham: Great. Yeah. So and again, you you know, in the phase three, you're you're using the every three months to to six month dosing. You know, based on the design, is this sort of the product label that you're you're shooting for? Maybe you can touch on what you might envision for that.

You know, of course, duration is is top of mind for everyone in the space. So just to get your your idea on that would be good. And, you know, just generally speaking, where do you think you you see CLSIX fitting into the wet AMD treatment paradigm?

Victor Chung, CMO, Clearside Biomedical: Yes. Absolutely. The label will be three to six months. That is actually what we we aim for. We have a brief discussion with the agency and but, obviously, label discussion at this stage are probably inappropriate, but that's what we aim for.

And, we saw the Visible and Eylea high dose label. So we kinda understanding that, you know, if we went for our phase three the way that we went through, then, you know, we would get the three to six months label. As I mentioned earlier, we reinforce the message that, you know, c l a a, you know, can last at least three months in almost everyone. So therefore that, you know, physician like would like that flexibility that every every three months will be good, you know, for everyone. And that physician can extend beyond six months if they wanted to.

So a label stay longer than six months being no sense, you know, you can always do seven months, eight months if you wanted to. So so I think that flexibility allowing easier adoption.

John Gianco, Member of the biotech, biopharma research team, Needham: Great. So then, you know, now looking beyond wet AMD, you guys briefly mentioned before, your intentions to expand its geographic atrophy. Just wanted to see what kind of color you guys can provide, regarding plans for these these programs considering they're still in the preclinical stage and how you see them fitting into your suprachoroidal portfolio? Yeah. So I think, first of all, c

Victor Chung, CMO, Clearside Biomedical: l a x is automatically thing that we focus on wet AMD purely because of the high commercial value and also most unmet need. Some some people argue that the need for Doctor and DME is smaller, but I think that is debatable and but we certainly will look into that. In particular, Doctor, diabetic retinopathy that without the risk of endomitis, without a risk of something floating around, that could be very compelling. So again, but that's something that we are certainly interested in it. In terms of geographic atrophy that, you know, really get excited that we had some approval a couple of years ago now.

And, you know, there's so many failure in geographic atrophy the in the past and even for complement that there's a lot of uncertainty that how the complement will work or might not work. So we decided looking into the space and say, well, that's great. You have complement activation, but the efficacy is relatively poor despite a monthly injection. So we think about two things. Number one thing is that while we certainly with suprachoroidal, we can extend and it's easier to extend to three to six months, like like what we've done in by the MD.

It might be even, you know, more towards six months easily. And so that's only one thing that we can do. And second is say that, well, you know, complement might be still used and then you might get a second drug and you might be able to get even better efficacy. So again, you know, like, in wet AMD is unusual. The anti wet just seem to be the only thing that work best.

You know, nothing improve the efficacy including the recent failure. And even by Bismol, so called attacking to to different area, but they don't improve the efficacy. So but again, you look at glaucoma, look at oncology, look at virtually every other disease that adding a different pathway will improve efficacy. So we pick two pathway that one is improve the corroded perfusion and one is improving or treating the polyinflammatory cell. The treating for perfusion have additional benefit that, you know, we understood that hit the cell might be a bit hypoxic.

By improving the perfusion, the patient might actually see better, let alone slowing down the progression. And treating the post inflammatory cell, treating the root cause of the complement in the first place because, you know, that we have complement to slow down the progression. So those are kind of slightly different aspect, you know, of where we want to go. And I think those are, you know, set the two area that we're interested to focus on. And indeed, that we find molecule that can actually do for us to formulate and put it into those space.

Those are also important that not every drug can put into the space and then not everyone can put drug in the suprachoroidal space either. So we have the expertise on the suprachoroidal device as well as the expertise of formulation this insoluble drug to get into the suprachoroidal space. So we are actively pursuing that. We have animal we have we are you have animal data already, but we're gonna share more as we go along aiming, hopefully, that we get the IND opening soon.

John Gianco, Member of the biotech, biopharma research team, Needham: Okay. Great. Yeah. We definitely look forward to all the updates in that moving forward. So, yeah, George, I guess maybe going back to you now.

You know, you had mentioned a couple of your partnerships a little earlier on in the call, but maybe if you just wanted to give a quick rundown on the progress that your partnerships have made in the recent year.

George Lazzakay, CEO, Clearside Biomedical: Sure. I'll start with Aura Biosciences, which has this viral like drug conjugate for treatment of choroidal melanoma. They're continuing to enroll their global phase three trial for choroidal melanoma, and they're doing very well. Very excited about suprachoroidal space. It's made a big difference in their approach, to treating choroidal melanoma, and then they're gonna start with treating metastasis as well, choroidal metastasis.

So they've been very excited, been a very good partner of ours. REGENXBIO, there's product now is it's continuing in phase two. They've enrolled some additional cohorts in phase two in wet AMD. But they're, they announced earlier this year they they plan to start a phase three trial with their r g x three fourteen, gene therapy in diabetic retinopathy in conjunction with AbbVie. So AbbVie and REGENXBIO have partnered around our g x three fourteen.

We constantly are holding meetings with three party meetings with REGENX, with AbbVie, and ourselves in order to help them train their trainers internally, AbbVie trainers, so they can go and expand their phase three trial. So we're very excited about the fact that AbbVie is encouraged and wants to go into phase three for diabetic retinopathy using our SES microinjector to deliver RGX-three fourteen. So they've had some really good success. Our Arctic Vision, our Pan Asia partner for what we call XIPERE in The United States, but it's called Arcadis outside The United States, Last year completed their Phase three trial and this year they've applied for approval in Mainland China. So that's exciting.

The data for their Phase three trial was very consistent with our Phase three data for uveitic macular edema, so it was more validation. And what was interesting about the Arctic, you know, we had to train their physicians during COVID. And we we couldn't go to China. They couldn't leave China, and so we had to train them remotely. And we had a very successful ability to train remotely, and it's it's really interesting.

As Victor's pointed out, the the the technique takes some practice, but it's actually fairly simple to learn. And I think training the Arctic physicians remotely from Alpharetta, Georgia to Mainland China during COVID proved that it's it's something that's easy to learn, can be done remotely, doesn't take a lot of time to learn it, and their physicians applied it very successfully. And like I said, their data from their phase three trial was very similar to our phase three trials that we conducted. So they're in the process of going through the regulatory approval process there in China. So we're hopeful that they'll get that in the near future.

BioCryst, they said with their plasma kallikrein inhibitor, which is a very insoluble, water insoluble molecule, for diabetic macular edema, they're hopeful to be in the clinic starting later this year. And so we've done a lot of formulation work with them and really kind of guided them through some of the ophthalmology hurdles that they need to understand as they start to conduct clinical trials, both here in The United States and then outside The United States as well. So, you know, the partnerships have worked well for us. I are always emphasizing to our team that we're gonna be the best partner we can be. It's our job to, really support those people that we decide to license our technology to to make sure that it it continues to work well.

I mean, we've had over 15,000 suprachoroidal injections with our microinjector. It's got a very good, safe, and reliable track record for, an in office procedure to deliver drugs to the suprachoroidal space.

John Gianco, Member of the biotech, biopharma research team, Needham: Great. That's perfect. Yeah. And as you said, just, you know, further validation of, of your technology platform. And, in the two minutes or so that we have remaining here, George, maybe you can just provide us with a little bit of a financial update in terms of cash runway.

I know in your your last earnings update, you had indicated potential intentions to to partner the CLS AX phase three program. Any further updates, although that was only a week or two ago?

George Lazzakay, CEO, Clearside Biomedical: No, John. We continue to pursue all options to fund a phase three trial to make sure that the value that's been created by the company in c l s, CLS AX continues to be magnified. So it needs to be moved on. We think it's a phase three ready asset. We think it has a very good chance of being accepted and approved.

And and with the kind of label that Victor has described, we think it could be a a great commercial success. So we are still actively pursuing multiple options to see that molecule move forward, for wet AMD in the suprachoroidal space. I think at the end of last year in December, at the December, we had about $20,000,000 in the bank, and we think that provides us with sufficient resources to continue doing what we're doing through fourth quarter of this year. But we're very active on the partnering and side. We're very active on other options to see CLS AX funded and get the phase three trial started, later part of this year.

John Gianco, Member of the biotech, biopharma research team, Needham: Great. Perfect. Well, George and Victor, thank you very much. I appreciate the time that you guys took to, speak with us today, and, looking forward to all the updates coming up later in 2025.

George Lazzakay, CEO, Clearside Biomedical: Thank you, John, for the time. Really appreciate it.

Victor Chung, CMO, Clearside Biomedical: Thank you for the time.

John Gianco, Member of the biotech, biopharma research team, Needham: Yep. Thank you.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.