Good afternoon. I'm Serge Belanger, one of the healthcare analysts at Needham & Company. I want to welcome everybody to Needham's 24th Annual Healthcare Conference. For our next fireside chat session, we have Pravin Dugel, the President and CEO of Ocular Therapeutix, with us. Before I hand it over to Pravin to give us an intro and kind of an overview of the company, for those who aren't familiar with Ocular, I just want to highlight that we will take Q&A. You can submit questions via the portal that you're watching the presentation on, and we'll take them as they come in. With that being said, I'll hand it over to Pravin.
Sir, thank you very much again for inviting us here. It's a pleasure and it's an honor to be here. Anytime we get to tell our story, especially when things are turbulent like this, is a great opportunity. What we are is a retina-focused company. This company has changed a great deal in the last year. What we're doing is to capitalize on an opportunity that is there and has proven to be there with other indications that we've seen over the last decade or two. The fundamental part of what we do is wet macular degeneration. The problems that we're trying to solve are two problems.
One is the fact that, as effective as the treatments are right now that are commercially available, the anti-VEGFs, the tragedy which we think is unacceptable is that 40% of patients in this country end up dropping out of treatment and going blind because of sustainability issues. That is one problem that we're trying to solve. The second problem that we're trying to solve simultaneously is that even those patients that stay on treatment eventually end up getting worse than baseline. That is not because of rebleeding, but rather because of fibrosis. That is felt to be because of the episodic pulsatile nature of our injections, which is on a monthly or bi-monthly basis. That is the second problem we're trying to solve. What we're trying to do with our product AXPAXLI is solve the problem of sustainability as well as better long-term visual outcomes.
Great. As you mentioned off the top, there was a change in management at the company last year, kind of a change in focus. Just what brought about those changes and the refocus of the company on retinal diseases?
It is a matter of the opportunity and the technology. I have known this technology from my previous company where we did a very, very deep dive independently with two different organizations based on the best sustained delivery format. Both independently came up with this ELUTYX technology. I had known about the technology. I had known about the studies that were done by this company prior to me being here in Australia and the U.S. As someone that has practiced for more than 30 years, I certainly understand the need that is out there. From a commercial point of view, I certainly saw historically what has happened. If you look at the success of Eylea over Lucentis or Vabysmo over Lucentis and Eylea, it is not based on increased safety or even increased efficacy.
It's really based on increased durability for about a week, couple of weeks, that kind of thing. The thirst is certainly there for technology that has a position for increased sustainability. That's the reason that I'm here, because I knew the technology and I certainly recognized the opportunity.
Let's talk a little more about that ELUTYX technology. Obviously, it was developed in-house, but how it differentiates AXPAXLI versus some of the other extended duration programs that are in development?
Again, there are two components, right? First is the TKI itself, and the second part is the format. The TKI we know scientifically proven is that it is the most potent TKI being investigated by about 200-fold and also the most selective. So the TKI is well proven, well known. As far as the format is concerned, the ELUTYX technology, this is not new. This has been FDA approved in other systemic indications. Literally hundreds and thousands of patients have been exposed to this, including on the eye itself, which is with our Dextenza technology. The special sauce here is that it's a tunable hydrogel. It's the same hydrogel, which is Dextenza, that we use in AXPAXLI. In Dextenza, it's tuned to last for a month. In AXPAXLI, of course, it's tuned to last for 10 months.
Also, the beauty of this is that the PK and PD are very closely matched so that when the drug is gone, the format is gone, the delivery system is gone. In other words, there is nothing left behind. There are no carcasses floating around. It simply is tuned to be both gone at the same time. As far as safety is concerned, which is really one of the first things that I looked at, and to me the most important thing before I joined this company, the safety profile has been absolutely spotless. As I say, it is not just spotless in terms of the ocular technology, but also in the systemic technology. Perhaps to me, what was most important is actually our glaucoma data, which is the PAXTRAVA data. The hydrogel is exactly the same.
Here, deliberately, PAXTRAVA is placed at what I think is the most susceptible part of the eye, which is the angle, and that's directly behind the corneal endothelium. As you know, the corneal endothelium is a neuroepidermal monolayer that doesn't regenerate and is exquisitely sensitive to any kind of toxicity, any kind of inflammation. Once the corneal endothelial layer is lost, there's corneal edema. With PAXTRAVA, we actually measured the number of corneal endothelial cells as well as corneal edema, and there was no difference. To me, that is the ultimate test of the eye of safety, placing this hydrogel in the most vulnerable position for the eye and seeing a completely clean safety profile.
Okay. So far, there's been two Phase I trials conducted with AXPAXLI, one in the U.S., another in Australia. Maybe speak to those and what you learned from each one that makes you believe that AXPAXLI can be a treatment paradigm-shifting product.
First of all, I've already addressed the safety issue. What we didn't see was any change in that whatsoever, the safety profile, which we didn't expect, of course, in the study in Australia or in the U.S. I think the take-home message from the study in Australia is that this is the first and only time that I know where a sustained delivery TKI has been used as monotherapy in a treatment-naive patient. In other words, with nothing at all, completely naked. What we saw were responses from these patients, again, treatment-naive patients used as monotherapy that you would expect to see for commercially available anti-VEGF. In my mind, there was no doubt that there was effectiveness of this that would be comparable immediately to the commercially available anti-VEGFs.
In the study in the U.S., it was used in comparison to Eylea, very closely designed to what we're seeing now in the SOLAR study, although it was done in a completely non-enriched patient population. That's something that I'm sure we'll talk about later on. Here, what we saw were results that were remarkably encouraging, which is that at six months, 100% of patients, literally 100% of patients were rescue-free. At 10 months, 80% of patients were rescue-free. We feel very, very good about both studies, but in direct relationship to the SOLAR study, we feel particularly good because remember, in SOLAR, we're doing a similar design in a specifically enriched patient population, enriched for stability. We're very confident of the results based on the U.S. study that has already shown results that are remarkable based on an unselected patient population.
Yeah. For the Phase III program, you guys took a very unique approach, at least one unique because it hasn't been adopted by others in the space. Maybe just talk about why you chose this path. Was it a function of the AXPAXLI profile that you had seen in the Phase I trials, or was it just another opportunity to seek additional differentiation?
Yeah. Look, that's probably one of the things that I'm most proud of. I take absolutely no credit for it because it was not my design. It was the team around me. I'm very, very, very proud of the team. I think they're the finest team ever assembled on this planet. I know that sounds arrogant, but I believe that that's true as far as retina is concerned. They're the ones that designed this. What I would say is the knee-jerk reaction, as you know, for decades and decades, and even now, is to have two studies because two studies are required for approval that are the same, right? When you think about it, that is terribly inefficient. I know it gets the approval done. Both are positive. The second study really adds no information whatsoever. It's simply a repeat.
What the team got together and designed is what I believe will be really the standard from this point on where two studies are designed in a complementary fashion. The FDA loves this because, as you know, what the FDA wants to do is to make sure that whatever conclusion was reached was reached scientifically and not by accident. There is no better way to do that than to have two different study designs reach the same conclusion. They love that complementary aspect to this. That is what we did. We designed a superiority study named SOL-1 and a non-inferiority study named SOLAR. The non-inferiority study, I think for a lot of people, was a surprise because everybody expected a SOL2, which we did not do. The advantages of doing this are many, and we have already realized most of them.
The first one is logistic, which is that we don't lose any patients. Everybody who screen failed in SOL-1 immediately rolled over to SOLAR. That is why we had such a bump in enrollment immediately after SOL-1 was completely randomized. Logistically, it worked superbly. From a commercial strategic point of view, it really answers all the questions that physicians and patients have. We have the potential of having the first and only superiority label that is flexible, six months to 12 months of treatment, as well as repeatable. It also answers questions regarding a head-to-head with Eylea 2 mg, also numerically relevant information as to Eylea as to head-to-head with Eylea high dose, which we should talk about as well.
From a regulatory point of view, and I think this is the part that has been underappreciated, remember that no regulatory agency is going to see either study without the other. The fact that the regulatory agencies will see how long this drug lasts based on SOL-1 and how it compares to the standard of care based on SOLAR is immensely powerful in terms of having complementary information together. I think it's a unique and absolutely trendsetting new design. Again, I take no credit for it as the team. I really believe that this will be the standard henceforth.
I agree about the advantages. I'm curious why you think other companies have not adopted the same approach. Are they just waiting to see on whether it's successful for AXPAXLI and then it'll become more of a trend going forward?
It is a good question. Look, there are certain things that need to happen. First of all, in a time like this, I could not be happier with what we have done, right? In a time of uncertainty like this, the fundamentals matter. We have done everything fundamentally correct. The most important thing probably is the regulatory pathway. That matters. The fact that we have a SPA, the fact that we have written types of the agreement, those kinds of things really matter in a time like this. The fact that we did not use sham, the fact that we have two complementary studies that help each other out in terms of answering all the questions, all those fundamental things that we have are what is going to shine, especially in a time like this. Why others have done it, I cannot answer.
If you look at the superiority study design, right, you may ask, why haven't others done that? Because it's exactly what the FDA wants. There is no sham. It's not a design that we made. It's a draft guideline that the FDA had to say, "Look, this is what you should do if you want a superiority study." The one thing I know is that you have to be convinced that your drug lasts for nine months, right? Otherwise, you wouldn't be doing that study. And we certainly are. Not only are we convinced that it lasts for nine months, we're convinced that we have the potential of getting a 12-month label. That's why we had the recent announcement, the recent amendment that we spoke about.
There may be many reasons others aren't doing it, but fundamentally, you have to be convinced of your technology to follow these FDA guidelines.
Yeah. Are these guidelines really just a recommendation, or is the FDA pretty rigid for companies to follow them in their clinical development plans?
I think that's where there's been a fair amount of confusion, Serge. I mean, I think others have said, "Look, we've gone to the FDA, and they've said sham is fine, and they haven't stopped us. It must be okay." The FDA is not going to stop you, right? The FDA is going to only stop you if there's a safety issue. And having sham, there is no safety issue. It's a masking issue. Of course, they're not going to stop you. The decision that we've made is that we're simply not going to do anything at risk. When you do something that veers away from the FDA guidelines, then you're doing it at risk. We're not going to be doing anything at risk. We've made that fundamental decision internally. Now, it does mean that you have to believe in your technology.
It does mean that it may be harder to recruit. It also means that risk is removed from the table. That's why everything that we've done with a SPA, as you know, in SOL-1 and with a type C written response in SOLAR has been exactly what the FDA wants. We've done that fundamentally without risk.
While we're on this subject of the FDA, I was curious if you're aware of the recent changes at the agency have impacted the ophthalmology division.
Here's what I know. We are very, very, very happy with the collaboration that we continue to get with ophthalmology. Nothing has changed. We feel particularly good for the reasons that we've mentioned. The fact that we're doing everything exactly the way they want us to do it, as validated by SPA, as validated by the written type C response, makes us feel even better. If you want proof of that, again, we haven't talked about the recent amendment, and I'm sure we will. Think about how many programs that you know. Again, all I know is retina. I'm a bit of a one-trick pony, but you may or may not know some.
I'm asking you this: that in the middle of a Phase III program like SOL-1, there has been a major amendment in the study design while not changing the SPA whatsoever. For the FDA to be able to do that with a sponsor, I think a major take-home message there is, boy, you must have great collaboration with the FDA in order to allow that to happen, right? Remember, in that amendment, we didn't give up anything. We're going to get to the finish line faster, cheaper, with potentially a better label. That has to speak to our collaboration with the FDA. Otherwise, I don't think that they would have allowed that change to occur while making sure that the SPA was completely protected.
I think if you want proof of our relationship with the FDA about how important it is to make sure that those guidelines are followed in terms of the collaboration with the FDA, I think that is it.
Yeah. Yeah. To answer your question, I've seen changes to Phase III programs, but not as part of a SPA. I feel like the SPAs are kind of a—we do not see them as often as we used to. It is interesting that your program is supported by a SPA. I think it is a positive.
I think especially at a time like this. I mean, one of the things, Serge, that feedback that we got, and perhaps it was a bit of criticism before the uncertainty we see now is, look, why are you doing all this? It's just not necessary. Why do you need to go and get a SPA? Why do you need to design the SOLAR study so that you've got this third masking arm? Why do you need to do all those things when it's really not necessary and others aren't doing it? Our response was always that, look, we're just not going to take any risks. As you know better than anybody else, look, drug development is not linear. You're blindsided by things. Macroeconomics change.
This is the time—in a time like this, this is when we feel very, very good that we've done everything we've done right down the fairway in terms of checking all the boxes.
Yeah. I think a SPA is a prudent approach when you're taking a new, unique path to approval, right?
Yeah.
That makes sense.
When you're taking risks and when you're veering off the guidelines and you're sort of going off the range, it doesn't mean you can't do what you do, but it just means that the risks become amplified in a time like this. In a time like this, when you're doing everything per the guidelines, I think you're rewarded. I think we feel very good about that.
Yeah. Let's talk about the most recent amendment to SOL-1. I think it kind of extends, pushes out the readout a little bit, but shortens the regulatory timelines. Yeah, how it came about and why it's important.
Let me just get to the bottom line. The bottom line is these amendments allow us to get to the finish line faster, cheaper, and potentially with a better label, the best that I think anybody has ever seen in our field. Let me just tell you how it happened and why it happened. Before this team was here, the previous team, to their credit, received a SPA based on SOL-1. SOL-1 concluded at month nine. There was nothing afterwards.
What we heard from the investigators is to say, "Look, you're putting me in a bit of a difficult position because once SOL-1 is successful, I have nothing for my patients until the drug is in the market." I just simply have to tell the patients, "Look, you're done." These are patients that volunteered to be in this study because they were so excited about the product. You're putting me in a position of having a difficult conversation with these patients. They were right. That is number one. Number two was we saw what happened with drugs such as Vabysmo, where they received a duration in their label, Vabysmo four months, as you know, based on very few patients actually crossing the threshold. Very few patients actually have to cross the threshold to get that on the label.
We looked at that and said, "Wow, there's no doubt in our mind that with AXPAXLI at 12 months, that number of patients will clearly cross and certainly more." That was the second thing. The third thing, and this was the gating factor, because one of the things that people ask me all the time is, "Look, if your team is that smart, why didn't you do this right away?" There was a gating factor. The most important gating factor was patient retention. All of us who've been doing this for 20, 30 years in the team, and we've got really centuries of experience in the team, collectively, we looked at each other and said, "We've never seen patient retention in the 30 or so years we're doing this that is this good," and referring to SOL-1.
Based on those three things, we had a discussion with the FDA, and we basically said, "Look, all of SOLAR, the 825 patients originally there is based not on powering, but based on the safety requirements for the FDA for unrestricted label according to how many patients they need at year two." Because as you know, in SOL-1, as I said, all the patients are going to end at month nine. That is why we have to have a very large patient population in SOLAR, not because of the powering, but because of the safety requirements. We asked the FDA, we said, "Look, we do not want to jeopardize the SPA. We do not want to jeopardize the SPA at all. But can we go ahead and have a year two where SOL-1 becomes a very efficient study?
The first year with a single injection, we look at the durability of the product. In the second year, with every six-month injections, we look at the maximal exposure and safety of the product. They said, "Yes." Without jeopardizing the SPA, they said, "Yes." We said, "If we can do that, can we then reduce the size of SOLAR from 825 patients to 555 patients because that'll satisfy the safety requirements?" They said, "Yes." What we have the potential of, and this is why the readout for SOL-1 is delayed by a quarter, is that if we keep these patients masked, right, we have the potential of including month 12 in the label. That is why we have to delay it by a quarter because we want to have every opportunity possible by keeping it masked.
Because if we unmask it, as it was originally designed in the end of 2025, we would not have any opportunity of having month 12 on the label. Because we are keeping these patients masked, we certainly have that potential of month 12 on the label. Again, we gave up nothing. That is important to understand. The primary endpoint remains exactly the same. The powering remains exactly the same. We gave up absolutely nothing. We now have the potential of having the best label there ever was in this field, getting to the finish line faster and getting to the finish line cheaper.
Okay. That makes sense. For the primary endpoint, if you can just talk about the powering around that endpoint at the nine-month, it's going to be nine months against Eylea. Just what kind of difference you're looking for?
Yeah. Based on our analyses with Eylea with a single injection, and there's some public information regarding this, specifically the TALON study, we expect about 20% of patients with Eylea will get to the endpoint. The endpoint, as you know, is at month nine and is the proportion of patients who maintain vision. Patients are rescued at any point if they lose 15 letters or more of vision, which would be a net of at most five letters of vision. We expect with AXPAXLI, again, in a non-enriched patient population, and this is the U.S. study, that that will be at least 70%. A 50% delta, and all we need is a 15% delta, 1.5, to be statistically significant. Now, realize one of the things that I think is really important is that we have very carefully enriched our patient population. These are VEGF-dependent patients.
These patients are designed to be VEGF-dependent so that they're designed to fail. All that matters at the end of the day for the success of the study is the delta, the delta between a single injection of AXPAXLI and a single injection of Eylea in the most VEGF-dependent selected patient population that we can find. Again, a very enriched patient population specifically selected for this study design. Also remember that everybody's counted. There are no patients who are censored. There will be patients that will be rescued off protocol for sometimes appropriately, obviously, that may not have lost 15 letters of vision. Everybody who is rescued, our SPA dictates, must be counted. Nobody is censored.
Obviously, that's very much in our favor because there will be many more of those patients who are rescued either on protocol or off protocol who are on Eylea versus AXPAXLI. Finally, what I have said is that under masking, and obviously, we're still masked, what I've said is that the most important goal of this company is the conduction of these studies, specifically SOL-1. What we study are three parameters. One is the number of rescues. The other is the cadence of the rescues. The third is whether those rescuers are on protocol or not. What I've said under masking is that we couldn't be more thrilled with what we're seeing now. I've also said that the vast, vast, vast majority of patients who are being rescued are being rescued on protocol. We're thrilled with what we're seeing under masking.
Okay. SOLAR. As part of the amendment, you were able to reduce the size of it. I don't know if you have any update on where enrollment is or what was the last update. I think it was in early January.
Yes, you're right. In early January, what we said was we had slightly over 300 patients in SOLAR, 311. These patients, so essentially, we already had a bolus coming in from SOL-1 once SOL-1 finished randomizing. We are recruiting SOLAR extremely well. I couldn't be happier. We haven't updated it as the guidance is yet. Clearly, what's happened with our recent amendment is that that delta of the card turn between SOL-1 and SOLAR now has been greatly reduced. Remember, we need both studies in order to submit to the FDA for approval of AXPAXLI. The primary endpoint for SOLAR is week 56. Week 56 now will come much, much earlier because we have a reduced sample size, right? Not 825 patients, but rather a third of that, only 555 patients.
As soon as we hit the primary endpoint in week 56, we will go ahead and submit for approval based on both studies. That timeline has been much accelerated with the recent amendment.
Okay. The SOL-1 primary endpoint readout really will de-risk whatever comes from SOLAR. Is that the right way to think about it?
We absolutely believe that. There are many reasons for that. Really, the primary reason, the simplified boil-down reason is, look, with a positive SOL-1, you absolutely de-risk SOLAR because the probability of success for SOLAR is sky-high with a positive SOL-1. The simple logic is, look, if there is a drug that lasts for 9-12 months, why would it not last for six months?
Yeah. Okay.
Remember also that we're very fortunate in not only having a singular non-blended primary endpoint at week 56, but we are also very fortunate to have a non-inferior margin of the maximal that the FDA allows, which is 4.5 letters.
Yeah. From a label standpoint, these two trials, as we talked earlier, should support a differentiated label.
Oh, absolutely. I mean, not only a differentiated label, but also the amount of information that the doctor and the patient will have, right? Again, obviously, we haven't had, I've got to say this, we haven't had labeling discussions with the FDA. It's too early for that. Having said that, there's a potential for the only superiority label in this field, the only one based on SOL-1, a label that allows flexibility of treatment every six months based on SOLAR to every 12 months based on SOL-1 and repeatability based on SOLAR. I mean, I believe that we're in great shape from a strategic point of view for very, very impactful and very good outcomes in terms of our labeling discussions. The other thing that I also want to mention is, look, and I think this has been underemphasized, that is the masking arm of SOLAR.
Remember, we have no sham as per the FDA's requirements, right, in either study. If you do not have sham, and the FDA has repeatedly said sham is not proper masking, and if sham is used, it is at risk, and we are not doing anything at risk. We need a masking arm. We could have chosen anything for the masking arm. It could be water. It just simply has to be the same cadence as your primary drug and the same rescue criteria as your primary drug. We chose high-dose Eylea for competitive advantages. That is not for statistical analysis. That is important. It is not for statistical analysis. It is for numeric analysis. It will potentially provide us a great commercial advantage in terms of the information that we have from that. Again, for numeric analysis only and for a commercial advantage in terms of our comparison with high-dose Eylea.
We're very happy to compare ourselves with high-dose Eylea. As you know, that may add another week or two weeks at most. We're just in a different orbit altogether. We're talking about 9-12 months, not just weeks. If you think about the thirst out there for anything that extends even a little bit, you can start way back by looking at Eylea versus Lucentis, which may be two weeks to now, Vabysmo versus Lucentis, which may also be two weeks or so. Look at the revenue growth in terms of Vabysmo based only on that. I mean, it's not safer. It's not more efficacious. It simply lasts two weeks longer. Again, we're in a completely different orbit. We feel very, very, very good about our commercial potential.
Speaking of that commercial potential, I guess with your label, you have the potential to play a frontline role similar to an Eylea. Is that where you expect to play, or it's more of a maintenance role post-initial Eylea?
Yeah. Sir, that's a great question. What I would say flippantly, and I'm not saying this, right? I'm just sort of telling you flippantly, is to say, like, why do I care, right? Even in the worst-case scenario, if this is a maintenance drug, it will be the most impactful drug ever in the history of our field. Having said that, look, I believe it's a first-line drug. Why do I say that? I say that for two reasons. One is based on the studies that we've, some of them we've presented in ARVO, for instance, that steady state occurs within 24 hours. Also because of what I mentioned earlier on, the study in Australia where it was used as monotherapy in treatment-naive patients. The results were what you would expect to see from commercially available anti-VEGF.
I will tell you, look, we have been intensely focused on the ramp or the loading phases and patient selection in both SOL-1 and SOLAR. The reason for that is not biologic because we do not feel that it is needed to have an anti-VEGF for loading. The reason we have done that for patient selection is because we want to enrich the patient population and give the trials in a bespoke manner the best chance of success. That is why we have done it. It is not for biological reasons. It is for patient selection. We have done that, I think, in the most thoughtful way possible that nobody else has to have exactly the right patient population for the trials that we have designed. The bottom line is, look, others or we will do that study to see, is this a first-line drug? Is it comparable to the anti-VEGFs?
We're not going to dive on the hill for that. Our job here is to get this drug approved. We're very comfortable with the fact that even in the worst-case scenario, which we don't think will happen, even in the worst-case scenario, if this becomes a maintenance drug, it will still be the most successful drug ever in this field.
Yeah. Okay. Thinking beyond wet AMD, I think you've started looking at NPDR and even DME. I think the next step there is to meet with the FDA. I'm sure we'll get an update on the next quarterly update. Would you go, and are those two separate tracks? Do you move to Phase II, or is it straight to Phase III on those indications?
First of all, let's look at the data. The Helios data was just phenomenal, in my opinion. It's not what I expected. It's not what any of us expected. It was a pure safety study. It was not a specifically selected patient population. It wasn't an enriched patient population. It was really all comers. The fact that every single parameter, and I mean every single parameter, was aligned in favor of the drug is absolutely remarkable. I mean, that's something that I really haven't seen in any study in which patients were quite unselected, particularly in a study that has the most amount of systemic variabilities. The most important thing from a clinical point of view is preventing these patients from going blind, right? We know that in advanced nonproliferative diabetic retinopathy, the risk of vision-threatening complications is 20%-40% year- upon- year.
In the control arm, that's exactly what it was. It was 37.5%. If you give a single injection, a single injection of AXPAXLI at week 48, that rate is reduced to literally zero. That is absolutely remarkable. That means that if this is duplicated in a Phase III study and approved, a doctor can sit in front of a patient and say, you know, your risk of going blind or having a blinding complication is 30%-40% year- upon- year. If you come to see me once a year, like you would go to see your dentist for teeth cleaning, I can reduce that risk literally to zero. I mean, that is remarkable. By the way, the other thing also is that every single patient that had diabetic macular edema, because these were selectively non-centre-involving diabetic macular edema, every single patient improved.
Who was treated, every single patient in the control arm got worse. We absolutely will target nonproliferative diabetic retinopathy and diabetic macular edema. How that will look depends on our discussion with the FDA. We're on track with what we said, which is that we'll have a discussion in the first half of this calendar year. Right now, that field of nonproliferative diabetic retinopathy and diabetic macular edema is wide open. We don't have any competition in nonproliferative diabetic retinopathy. It's a huge market, and we absolutely will go after that.
Okay. We really have a few minutes left. Maybe if I can get you to give us an overview of financials.
One of the things we've done, as you know, is to be very, very disciplined from a financial point of view. At the end of the last calendar year, we announced that we had $392 million in cash and cash equivalents. We also announced that we're on track to go to 2028 from a cash point of view. That is well beyond the completion of the SOL programs. That does not include the nonproliferative diabetic retinopathy and diabetic macular edema program because we do not have a final study on that as yet. From a cash point of view, I think we're in very, very good shape, which matters a lot, obviously, at a time like this.
Absolutely. Maybe just to wrap up, anything you feel is misunderstood or underappreciated about AXPAXLI?
I think, you know, and again, thank you so much for allowing us to be here. I really appreciate the invitation. We touched on a lot of things, but I think the most important thing that anybody can look at here is how thoughtfully these trials have been designed and how thoughtfully patients have been selected. These patients are the most de-risked patients that are carefully selected and bespoke for each study that I've ever seen. Patients that are VEGF-dependent in the SOL-1 study, which is exactly the kind of patients you want, and patients that are stable and super selected and enriched and de-risked in the SOLAR study. That, I think, is the most important thing. The way the patients are selected, and we've already touched on the complementary nature of this trial.
Again, I'll end with this, which is at a time like this, the fundamentals that we've had, the boxes that we've checked, the fact that we have a clear regulatory path that's in writing is going to be extremely important. I think this is where the fundamentals shine, and we feel very, very good about where we are.
Let's end it here. I want to thank you for spending time with us this afternoon and telling us more about Ocular Therapeutix. It's an exciting story.
Thank you, sir. Thank you for the opportunity, and thank you very much for having us here. I'm very grateful.