Greetings, and welcome to the Oculis conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone would like to require operator assistance during the conference, please press star zero on your telephone keypad. Please note that this conference is being recorded. I would now like to turn the call over to Sylvia Cheung. Thank you. You may begin. Thank you, Julian. Earlier today, we issued a news release providing top-line results from Oculis phase III results with OCS-01 in diabetic macular edema. A copy of this news release and the presentation accompanying this call are available on our investor relations section on our website. Before we begin, I would like to remind everyone that some of the statements we are making today are forward-looking statements under applicable securities laws. Forward-looking statements include, but are not limited to, statements regarding our regulatory and development plans for OCS-01, the timing, progress, and regulatory strategies for our other development and research programs, and our cash runway, and statements about the potential therapeutic effects of our product candidates. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that we expect. We encourage you to read more about these risks and uncertainties associated with our business in the sections entitled Risk Factors and Cautionary Note regarding forward-looking statements and documents that we file or furnish with the SEC. Any forward-looking statements speak only as of today, May 29, 2026, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. Now, I will turn the call over to our Chief Executive Officer, Riad Sherif. Thank you, Sylvia. Thank you to everyone for joining us to discuss the results from the phase III program with OCS-01 in DME. Needless to say that we are naturally disappointed with the outcomes, as both DIAMOND-1 and DIAMOND-2 studies did not meet primary endpoints. This first slide shows two type of endpoints. The first one is visual function, which is the functional endpoint and the regulatory endpoint and the primary endpoint of the study, which is a typical DME endpoint at week 52, which shows that the DIAMOND-1 and DIAMOND-2 didn't meet the both endpoints. The second endpoint is retinal anatomy, which is an objective measure of drug effect in retina, which show then we will go into the details in the next slide, which shows actually a rapid and sustained reduction in active arm versus vehicle through week 52. On a safety point of view, OCS-01 was well-tolerated with no unexpected safety findings. Based on this top-line result, at this time, Oculis does not plan to pursue FDA regulatory filing with OCS-01 for DME. We go now to back to the study and go into the details of the results, let's start with study design and patient population. You may recall, a DIAMOND program was two trials, identical trials, DIAMOND-1 and DIAMOND-2, with the objective to evaluate the safety and efficacy of OCS-01 versus vehicle for the treatment of DME in two adequate, well-controlled, multicenter global phase III clinical trials. The primary endpoint, as aligned with FDA, was change in BCVA ETDRS letter score at week 52. The key secondary endpoint was percentage of patients with equal or superior to 15 letters gain in BCVA at week 52, and the secondary endpoint was CST change versus baseline. The study population was an adult population with a DME following diabetes type 1 or 2 with inclusion criteria with ETDRS BCVA letter score between 24 to 65 and retinal thickness equal or superior to 310 microns. The study was a one-to-one. We had six weeks induction phase and 46 weeks maintenance phase. The endpoint of the readout was at week 52. If we go to the patient disposition, the two parallel studies, which were exactly the same, DIAMOND-1 and DIAMOND-2, randomized 404 patients in DIAMOND-1, 401 in DIAMOND-2. We had per arm around 200 patients, and we were able to have more than 80% of patients completing the drug. This shows a very good and very solid execution of the protocol for a 52 weeks study with the daily treatment. Superiority trial compared to vehicle. If we go to the next slide, which is the DIAMOND baseline demographic, we can see that the two groups in both trials, DIAMOND-1 and DIAMOND-2, were well-balanced in terms of age, sex, duration of DME, BCVA baseline, which is in fact pretty similar to what we had in the Stage 1, DIAMOND-1. CST as well, IOP, and treatment status between naive and previously treated, and lens status between phakic and pseudophakic. We will now go to the efficacy. We will start with objective measure, which is the CMT. Here you have each data point till week 52, where we see a rapid and sustained reduction of the thickness of the retina. You have the dot at week six and at week 12, which are the result we got in Stage 1, and it is very similar. We were able to replicate what we saw in Stage 1 very closely, almost the same number, in fact, in terms of OCS-01. If we go to the next DIAMOND-2, we see the same thing, rapid substantial improvement and rapid and sustained over time in DIAMOND-2 as well vis-à-vis vehicle till week 52. Despite this very clear and objective drug effect in the retina, this was not translated in BCVA functional improvement, and we can see it in the next slide where we see the mean change, where the OCS-01 didn't reach the positive endpoint in both DIAMOND-1 and DIAMOND-2 in the function, in both mean change BCVA and also responders, which we see in the next slide. We go to the safety profile. OCS-01 was well-tolerated with no unexpected adverse event observed. Overall, the safety profile was consistent with that of previous trials. As expected, elevated IOP and cataract were higher in the OCS-01 treated patients and in line with chronic use of steroid DME. We go to the summary. I would like to summarize the situation. Following the top-line result of DIAMOND-1 and DIAMOND-2. Despite showing a rapid, substantial, and sustained reduction in retinal thickness in patients treated with OCS-01, which is an objective measure, primary, which was mean change in BCVA, and key secondary, which was the gainers endpoint for both trials were not met at week 52. Based on the result, at this time, Oculis does not plan to pursue an FDA regulatory filing for OCS-01 in DME. Oculis will strategically focus resources on advancing our late-stage portfolio, including the Privosegtor platform, starting with the PIONEER program for Privosegtor in optic neuropathies and the PREDICT-1 trial for licaminlimab. I would like to give an update about these two assets as well. To drive precision medicine in dry eye disease. We can do so thanks to our strong balance sheet with $278 million in cash equivalent, and short-term investment as of March 31st, 2022. Which provide us cash runway into the second half of 2029. Before going into the Q&A, I would like rapidly just to make an update on PREDICT and update on PIONEER. As already communicated, we started the PREDICT-1 registration trial for dry eye disease to drive the precision medicine late last year. The trial is planned to enroll 160 patients randomized into two arms. The primary endpoint is the global ocular discomfort score at day 29 in patients with TNFR1 positive. The trial initiation activities are proceeding accordingly to plans, and planned site activation expected to be fully completed around midyear. We have approximately 70% of planned sites in active screening with prospective patients in the run-in phase prior to randomization. The trial is in early stage, and we will provide update later in the year, of course, as things progress. For Privosegtor, our PIONEER program has three trials for optic neuropathies. PIONEER- 1 and PIONEER- 2 are for optic neuritis, and PIONEER- 3 is for NAION. We received the breakthrough therapy and prime designation for the optic neuritis, which speaks to the agency recognition of the unmet need in this disease. The PIONEER- 1 trial design is aligned with FDA under SPA. The total execution program is focusing on preparing the centers, educating the centers, training, and monitoring all aspects of protocol to make sure that the execution of the protocol is perfectly done. We now have over 70 U.S. and international sites currently in various stages of activation. Enrollment into the study is, of course, event-driven, but we expect to treat our first patient in the near future. Thank you very much, and I would like to open the session for Q&A. Thank you. With that, we will now be conducting a question and answer session. Our first question comes from the line of Annabel Samimy with Stifel. Please proceed with your question. Hi, everyone. Thanks for taking my question. I'm sorry to hear about the disappointing news on OCS-01. You do have, obviously, two very valuable programs in Privosegtor and OCS-02. Maybe you can help us understand whether you have right now the ability to accelerate the initiation of the additional programs that you were going to explore for Privosegtor, not just in ON and NAION, but perhaps in MS or perhaps work on accelerating the formulation for other broader indications that could benefit from neuroprotection. I guess that's my first question. For OCS-02, I guess we can sort of ask the same given that only one of the trials right now for dry eye is underway. What are your thoughts around bringing these programs forward a little bit faster? Thanks. Thank you, Annabel. Yeah. To the first question, in fact, I completely agree with you. The Privosegtor is, as we say it and as you know, really a platform. We will make sure first really to deliver on PIONEER- 1. This is very important, and this is very important to deliver quality trial, and potentially a successful trial. This is our aim. I think the good news with PIONEER- 1 is we are really repeating exactly what we did in ACUITY in terms of dose, regimen, patients, and duration. We had a readout at month three. We are repeating readout at month three, which gives us most probably a strong confidence about it. This is important for PIONEER- 1 and PIONEER- 2, which are optic neuritis. Of course, we just had this top-line result. As we said, we will refocus or even focus more our resources into the Privosegtor platform, and we will be very happy to come back to you and to all your colleagues to give an update about what we would like to do more. I would say for us, focusing on PIONEER full program and delivering against expectation is the most important. On licaminlimab, really the strategic choice for the company is to do the first trial. If you recall, we did two trials where we showed efficacy in the TNFR1 in symptoms and signs. In signs, it was pre-specified. In symptoms, the first trial was exploratory. We want to repeat it in a pre-specified manner. This is what we are doing. Once we have the data, we will be able to advance in the rest of the trials with licaminlimab. Okay. Got it. Thank you. Thank you. Thank you, Annabel. Thank you. Our next question comes from the line of Yatin Suneja with Guggenheim Partners. Please proceed with your question. Hey, guys. Thank you for taking my question. Tough news today. Two for me, one on PIONEER, second on PREDICT. Number one on PREDICT. With regard to that study that you're running, how would you characterize, like that still is a phase II Is it a phase II study? What will be the regulatory strategy if this study is successful? Do you need another one? How should we think about enrichment? With regard to the PIONEER study, obviously now you have an alignment with the FDA, you have a SPA on the endpoint. Can you maybe just talk about how should we think about the responder analysis versus an average increase in BCVA? How does this sort of help you achieve the goal with the current endpoint of responder analysis? Thank you. Thank you, Yatin. For the first trial, PREDICT-1 is a registrational trial, therefore, it will be part of the registration of the product. What we always said about dry eye, we wanted to separate signs and symptoms, therefore we always said we would like to do two trials in signs and two trials in symptoms. As you know, we heard about FDA, that they wish to go to one trial. If this materializes, we don't know yet, if this materializes, it will mean that for us, it will be one trial in symptoms, one trial in signs. I would say the strategy is the following. Let's deliver on PREDICT-1, meet with FDA, and clarify how many trials we need. At least the base case scenario, what we've always communicated is two trials in signs, two trials in symptoms. The benefits of the TNFR1 is it gives us the trials which are much more efficient in terms of capital deployment and risk. You see PREDICT-1 is 160 patients. It's almost unheard of in dry eye. These are very small trials, very efficient in terms of number of patients and therefore capital needed, but also should be a lower risk if the hypothesis of the TNFR1 materializes, which is our aim, is to validate this hypothesis in the PREDICT-1. This is on OCS-01. On OCS-05 or Privosegtor. Yes. The primary endpoint is responders. The secondary endpoint is mean. Therefore, in all our statistical calculations, both endpoints actually are solid, are positive. The sample size is in all our hypothesis actually very solid. It just allows us with the responder analysis, it allows us to have one endpoint instead of two. It's the only difference. If I take the DME trial, for example, or wet AMD trial, like the typical DME trial, the typical wet AMD trial, you always need to hit both. You need to hit mean, and you need to hit responders. Unless you go with only responders. If you go with only responders, then if you hit responders, then it is a winning trial. This is why it was actually better for us in terms of risk management to go with one endpoint, which is responder in this case. Got it. Thank you. You're welcome. Thank you, Yatin. Thank you. Our next question comes from the line of Tessa Romero with JPMorgan. Please proceed with your question. Hi, team. Thanks so much for taking our question this afternoon. If you had to look big picture at the data that you generated in these two studies, what do you think the misstep was? I know this was the top line, but what is your view at this stage at what factor or factors drove these results, particularly around vehicle and also the variability that it seems to have appeared in this study and, or the studies, and was greater diabetic control a factor here? Thank you. Thank you, Tessa. With the data we have in hand, which are only top-line research, as you know, we don't have the full data. We did the multiple analysis, we do not see reason why placebo is behaving the way it is behaving in these two trials. In fact, when you compare in any other DME trial, the five letters in placebo is more than the double of the best placebo response in any other trial. Therefore, it's surprising. I completely agree with you. Now, as you know, the variability in DME is very high. The way we treat DME today is different, diabetes, actually, because in the end of the day, DME is a complication of diabetes. The way we treat diabetes in 2024, 2025, 2026 is different from 2010. We have GLP-1, we have a new product. Therefore, this might change, but we don't have all the data to explain it yet. All the assessment we did so far really does not give a clear picture. Most probably it is a mix of multiple things. Okay. I would say there are multiple things we can ask ourselves. Do we have a drug effect? Yes, we have a drug effect in DME. Do we have a safety profile which is clean? Actually, the safety profile is very clean. It is very unfortunate that I have to say that we were not able to hit on the regulatory endpoint, which are BCVA at week 52. You know that the need for a topical product is huge for patients, and it is really unfortunate for patients as well. Okay. Riad, just to follow up here, it sounds like based on what you know today, you don't think there were any clear clinical trial conduct issues across your sites? No. This was a very important question, as you can imagine. We cross-checked everything in terms of quality of the execution of the protocol. I have to say in a very clear manner, the execution of the trial was very good. Was really good. It's really not a problem of execution at all. Thank you. You're welcome. Thank you. Our next question comes from the line of Marc Goodman with Leerink Partners. Please proceed with your question. Hi, everyone. This is Alyssa on for Marc. Just a few questions from us. You mentioned that you're planning on giving an update towards the end of the year on licaminlimab. Can you explain or provide a little bit more color on what those updates will be? When we might expect data from PREDICT-1? Secondly, could you give an update on how site activations are going with Privosegtor and PIONEER-1? Thank you. Yes, of course. On PREDICT, what I have been saying is really towards around the end of the year, I would say the very end of the year, the beginning of the next year. This is what we say. Therefore, it's still aligned with this. The activation is going as planned. Now, because we are selecting basically patients on TNFR1, we need to screen much more patients to be able to select patients of TNFR1, and this is ongoing. This is why we will give an update based on screening and based on randomization towards Q3, because we'll have a better view on where we are in terms of randomization and so on. So far, the plan is really around the end of the year, beginning of the next year, basically. On Privosegtor. Yes. Basically just to step back. We initiated PIONEER-1 in the end of the last year. Between initiation and randomization is in average, and this is just a benchmark I'm sharing. In average, it's between six to nine months. Therefore, we are on schedule vis-à-vis what we assumed, because as you can imagine, we need to make sure that the protocol is executed, we have the approvals, we make sure that we train centers, we certify the centers for LCVA. We have the infusion center for injecting the product. We have the MRI system in place. It is actually an easy study in terms of duration. It's five days. It's three months. It's two LCVA, one at baseline, one at month three. But we need to put everything in sync to deliver a quality study. And quality is really important for us. We are doing what it needs to make sure that execution is solid after. Overall, we are on schedule based on what we planned on PIONEER-1. Now, PIONEER-2 will be initiated, to be precise, as soon as we start to randomize patients in PIONEER-1. I would not like to take a risk to start PIONEER-2 without starting concretely and materially to randomize patients in PIONEER-1. Okay. Thank you very much. You're welcome. Thank you. Thank you. Our next question comes from the line of Colleen Kusy with Baird. Please proceed with your question. Hey, everyone. It's Nick on for Colleen. Thanks for taking the question. Just a couple here. Just wanted to know if you had any color on the compliance in the study and if you saw if that was a factor that may have led to the results here. A second question, just thinking of the OZURDEX results where you saw a better signal in pseudophakic versus phakic patients. I know it's top line, but wondering if you saw any difference there and just in general if you see potential look for a signal that could warrant going after an approval in a subgroup of the DME population. Thank you. No, we didn't see a material difference between the groups. The compliance was monitored, it was as expected, actually high. In line with the Stage 1, therefore it is not a compliance. It is not cataract. This is why I really highlighted execution because it was an important question for us. It's schizophrenic what I'm going to say, within the context of a study which is not positive, the execution was extremely good. Everything we decided we control in terms of cataracts, in terms of IOP, in terms of dropout, everything was within the KPIs we set in place in the beginning of the trial. Therefore, nothing really to highlight. Thank you. Our next question comes from the line of Patrick Dolezal with LifeSci Capital. Please proceed with your question. Hi. Thanks for taking the questions. Yeah, apologies on the disappointing outcome here. Appreciate some of these post-talk learnings that you're speaking to, though. Just a quick one. You recently announced the SPA for PIONEER, as noted, the primary endpoint is the proportion of patients with three-line Low Contrast Visual Acuity gains. Could you just contextualize the data from the phase II ACUITY study that give you confidence on the likelihood of success on this responder endpoint in PIONEER as opposed to, say, mean LCVA gains? Thanks. Thank you, Patrick. Basically, as I shared, the responder analysis was really our choice. Why? Because it allows us to have one primary endpoint. If we go with the two, we could have done mean. I'm not saying it was not an option. It was an option, mean is sufficient only when the difference is 15 letters and more. If it is below 15 letters, it's like DME or wet AMD, it really is the same. If it is below 15 letters, you need the secondary endpoint. You ask yourself, okay, the variability between phase II and phase III is important, and we see it. Therefore, it's better to be conservative and to go with the responder. Then we took our data on ACUITY, and we did the multiple models, reducing the mean, and it allows us actually to have a higher probability to deliver the 15 letters than mean higher than 15 letters, basically. This is why we are more confident about it. The second part of confidence, which is really important, is we are repeating not 99%, but 100% of ACUITY. Really knowing the endpoint at three months and repeating the endpoint at three months is crucial. This is what we are doing in PIONEER-1. Thank you. Our next question comes from the line of Jason Gerberry with Bank of America. Please proceed with your question. Hi, this is Melanie on for Jason. Just one question from us. Does this study result elevate your internal bar for licaminlimab in dry eye, given the inherent variability in dry eye data sets? I would say you are totally right. First, dry eye has a very high variability, just a fact. This is why we decided to go with the genotype and not to go to all comers, because we totally recognize it. It's just fact. This is why we always say, and we will continue to say it even more, we will not go to dry eye without the TNFR1 positive. This is why we decided also to do only one trial, go to TNFR1 positive, and we have high expectations from it. It need to be true precision medicine, which means that we expect an endpoint which is not 10% or 20% better than another product, but much better. The way to address the variability is really to do what we are doing, which is a biomarker which allows us to see consistently in signs and symptoms that we have a much higher response. If you recall, five times more in signs and seven times more in symptoms. You are right. Yes, dry eye has high variability. Our response is the precision medicine. Our next question comes from the line of Dan Akschuti with Pareto Securities. Please proceed with your question. Hi, Riad, and thank you for taking my questions. Obviously very sad. At the same time, I think very good that it's communicated directly that you halt the program. Just one question or follow-up. There was already one question on the pseudophakic and phakic that we see from OZURDEX data. You mentioned you haven't seen any difference there. If you could just elaborate there, if it was really just nothing in the top-line data or if you need to wait for the full data set? The cash runway into second half 2029, that is already now assuming no further major expenses for OCS-01, just the winding down activities. Thank you. Thank you, Dan. First for cataract, we didn't see a meaningful difference. I think that somehow it showed that we said we will control for cataract and we did it. We didn't see a meaningful difference really between phakic or pseudophakic. In terms of runway, yes, with what we have in hand and with the plan we want to execute, we have cash till the second half of 2029. Our next question comes from the line of Yi Chen with H.C. Wainwright. Please proceed with your question. Hi, this is Katherine on for Yi. I just wanted a couple quick clarifying questions for modeling purposes. Are there any wind-down costs associated with the DIAMOND programs that'll hit in the near-term quarters? Can you clarify the current status of any licensing agreements tied to OCS-01 and whether there are any outcome triggers that modify any financial obligations? I will ask our CFO, Sylvia, to address the question. Please, Sylvia. Thank you, Riad. Thanks, Katherine, for the question. With regards to license fees, the answer is no. Oculis owns the technology OPTIREACH as well as the candidate OCS-01, so there's no payments related to it. Normal site closeout costs related to the DIAMOND-1 and DIAMOND program are expected in Q2 and the beginning of Q3. That's just normal part of routine site closeout expenses. Thank you, Sylvia. Yeah. Thank you. Thank you, Katherine. Our next question comes from the line of Serge Belanger with Needham & Company. Please proceed with your question. Hi, good afternoon. A lot of questions already. A lot of questions been answered, maybe just one. I believe OCS-01 was put through a registrational study for post-ocular surgery in the past, and it was ready for NDA filing. Just curious if you plan on going forward with that or if somebody else maybe would be willing to take up the baton and move it to registration. Thanks. Yeah. Thank you, Serge. Yeah, you are totally right. We were and we are ready actually to file for ocular surgery. We will make a full assessment, and we'll take a decision, but the file is ready for ocular surgery. Yeah. Thank you. With that, this does conclude our question and answer session. I would now like to turn the floor back to Riad for any closing remarks. Thank you. Thank you all. I really would like to just thank the patients, investigators, and all the clinical experts who help us. I would like to also thank our investors, and all the analysts who have been very supportive to us for the last years. Thanks to our strong balance sheet currently and also, very importantly, to a very differentiated product with Privosegtor, which has the potential to go to diseases where we do not have any solutions such as optic neuropathies, but also to go to MS. If you recall, we have this plan to meet with FDA in the second half of the year to discuss the MS potential and to broaden the optic neuritis into relapse of MS. Also with licaminlimab, which is a very differentiated, innovative product with precision medicine. We are extremely now focused on these two candidates to bring value to investors and bring solutions to patients. Thank you all for your support. Appreciate it. Thank you. With that, ladies and gentlemen, this does conclude today's teleconference. We all thank you for your participation, and you may disconnect your lines at this time, and have a wonderful rest of your day.