Ocular Therapeutix, Inc.

Good morning and welcome to the Ocular Therapeutics second quarter 2025 earnings conference call. At this time all participants are in a listen only mode. After the prepared remarks we will conduct a question and answer session. To ask a question please press star 1. As a reminder this conference call is being recorded and will be available for replay on the investor relations section of the Ocular Therapeutics website. I would now like to turn the call over to Ocular's Vice President of Investor Relations, Bill Slattery Jr. Please go ahead Mr.

Slattery. Good morning everyone and thank you for joining us today. Earlier this morning we issued a press release and filed our quarterly report on form 10Q, outlining our financial results and business updates for the second quarter of 2025, along with several updates to our registration program for ex-Paxley and wet AMD. Ocular's Executive Chairman, President and CEO, Dr. Praveen Dougal, will summarize recent business highlights before we move to our question and answer session. Joining Dr. Dougal for the Q&A portion of the call will be Donald Notman, Chief Financial Officer and Chief Operating Officer, Sanjay Nayak, Chief Strategy Officer, and Steve Myers, Chief Commercial Officer. We refer everyone to this morning's press release and our form 10Q for a comprehensive update of second quarter 2025 financial and business results. During today's call certain statements we will be making constitute forward-looking statements under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially as a result of a variety of risk factors, including risks and uncertainties identified in the risk factor section of our annual report on form 10K and our other SEC filings. With that, I'd like to hand the call over to Dr. Praveen Dougal to review our recent updates. Praveen?

Good morning, everyone, and thank you for joining us today. 2025 is shaping up to be a defining year for ocular therapeutics. As we look back on the progress made over the first half of the year, I'm proud to say we are continuing to execute with precision, speed, and scientific integrity. Last month, we updated our corporate branding to reflect who we are today, a company advancing with purpose backed by the momentum of our soul trials and fueled by our unwavering commitment to patients. These changes represent more than a new look. They mark the next chapter in our evolution as a retina-focused company at the forefront of innovation. Our mission remains unchanged, to redefine the retina experience in hopes of preserving vision for the long term. For millions of patients around the world, wet AMD remains a relentless progressive disease. Despite recent advances in therapy, the burden of frequent injections remains unmanageable for many with nearly 40% of patients in the U.S. discontinuing treatment within the first year. This is unacceptable to us. And it's exactly why we're advancing ex paxly, a treatment designed to offer best in class durability, meaningful efficacy, and real world flexibility. Our registration program for ex paxly includes the Sol 1 and Sol R studies. These are thoughtfully crafted, complementary trials with bespoke patient populations designed to de-risk outcomes and answer key questions physicians will have on the durability, flexibility, and repeatability of ex paxly. If approved, we believe ex paxly has the potential to be the first product for wet AMD with a superiority claim based on the Sol 1 trial. This trial is designed in alignment with the FDA's guidance for conducting a superiority study which has enabled us to secure a special protocol assessment or SPA, SPA agreement for Sol 1. Recently approved anti-VEGF products and current competitive phase 3 wet AMD trials are all based on non-inferiority to a flipper set 2 milligrams. To our knowledge, Sol 1 is the only phase 3 superiority trial being conducted in wet AMD. And if we're successful in gaining FDA approval, we will potentially be the only wet AMD product with a superiority claim in the label for the foreseeable future. Combined with our non-inferiority trial Sol R, we believe ex paxly has the potential to unlock unprecedented durability with dosing of at least six months and potentially as infrequently as every 12 months. We believe this dynamic will allow us a unique and potentially dominant position compared to all other products in the commercial landscape and could enable an opportunity that spans millions of patients worldwide addressing the critical needs for a more sustainable, less burdensome treatment with improved long-term outcomes. This morning, we're excited to share several updates across our Sol 1 and Sol R programs, including initial plans to incorporate a single long-term open label extension study for both Sol trials and updates to our rescue criteria for Sol R. These updates are designed to further enhance ex paxly's commercial profile and underscore the confidence we have in this program. We'll also provide a financial update that highlights the flexibility and optionality we've secured as we approach the Sol 1 top line data readout in the first quarter of 2026. Continue to advance our manufacturing and commercial infrastructure and evaluate expansion opportunities for ex paxly in non-proliferative diabetic retinopathy and diabetic macular edema. Finally, we are pleased to announce that we will be hosting an investor day on September 30 in New York City, which we encourage everyone to join either virtually or in person. Let's first discuss our Sol studies. I am pleased to report that both Sol 1 and Sol R trials continue to move forward expeditiously. Trial conduct has been exemplary and retention across both studies continues to exceed our expectations, underscoring the strength of our sites, the commitment of our investigators, and the quality of our operational planning. Let me start with Sol 1, our superiority trial for ex paxly. Following the successful randomization of 344 patients in December 2024, the trial has maintained exceptional retention as we prepare for top line data in the first quarter of 2026. As part of the ordinary course of our trial monitoring, we periodically review rescue data on a massed basis. And what we look at are primarily three things. First, the number of rescues. We need patients to be rescued to demonstrate a difference between the flibberset and ex paxly. Second, the cadence of rescues, whether they occur in a distribution that is consistent with our hypothesis as to how a flibberset patients would behave and how ex paxly patients would behave. And third, whether the rescues are on protocol or not as this goes to trial conduct and the reliability of data we are generating. I am pleased to share that the vast majority of rescue events remain fully aligned with the pre-specified criteria outlined in the Sol 1 protocol. Simply put, patients are staying in the trial and physicians are waiting until patients meet the predefined threshold of a 15 letter loss in visual acuity from baseline before administering rescue treatment in the vast majority of cases. That's not just a procedural win. It's also a powerful testament to the integrity and reliability of the data we are building. And this reinforces our confidence in the quality of the data set we intend to deliver to the FDA. And when we step back and look at the number and cadence of rescues, again under masking, we are also thrilled with what we're seeing. This is based on our expectations of the difference in how the two agents would perform over time. We look forward to hopefully confirming that hypothesis once we are able to unmask the study in Q1 of next year and report top line data. We are also excited to announce plans to incorporate a long term open label extension study for both Sol 1 and Sol R, which patients will be eligible to enter following the completion of the two year safety follow up period in each trial. This extension study is a strategic initiative, not a regulatory requirement. We believe it will generate valuable real world insights into the potential long term benefits of using a non-pulsatile treatment like x-paxly in addition to providing long term safety data. The study is designed to assess key outcomes such as vision preservation, anti-fibrotic activity, and the potential consequences of delaying x-paxly treatment in control arm patients. Our hypothesis is straightforward. If non-pulsatile dosing reduces the risk of fibrosis and atrophy, the x-paxly arm patients will have the potential for better long term visual outcomes than the control arm patients who have a two year delay before they initiate x-paxly treatment. Importantly, we expect this extension study will have significant commercial implications. In today's evolving landscape, retina specialists and payers alike are seeking long term data that validates durability. We believe this study will enhance confidence in x-paxly's sustained performance and support broader adoption upon launch. We're extremely excited to take on this effort as part of our commitment to delivering a long lasting flexible and non-pulsatile solution that could potentially deliver improved long term visual outcomes on a treatment regimen that is sustainable for patients, caregivers, and physicians. Turning now to Solr, our non-inferiority trial comparing x-paxly dosing every 24 weeks to a flippers that dose every 8 weeks. We continue to advance this study with strong momentum and unwavering conviction in both our strategy and execution. This trial was deliberately designed with a six month screening and loading ramp to identify and exclude patients who demonstrate unstable anatomy, particularly those with high fluctuations in central sub-field thickness. These are precisely the patients who could introduce variability and compromise outcomes in a non-inferiority trial. Excluding them is a strategic choice because a failed trial due to noise is not a risk we're willing to take. With enrollment complete in Solr, we expect to have top line data in the first half of 2027 and we believe the structure of this trial gives us key advantages needed to succeed by de-risking the patient population. The primary endpoint for Solr is to demonstrate non-inferiority in the mean change in best corrected visual acuity at week 56, which is a highly favorable time point. It falls two months after both the last ex-paxly dose and the correspondent of flippers that injection for the control arm. Importantly, this endpoint is at a singular time point. It is not blended over multiple visits. Separately, as part of our ongoing effort to ensure Solr reflects real world clinical decision making, we streamlined and simplified the rescue criteria. The rescue criteria in Solr is now based on a greater than five letter loss in visual acuity plus a greater than or equal to 75 micron increase in central sub-field thickness. This change aligns the trial more closely with how physicians determine when to intervene in the real world and simplifies the criteria for investigators to reflect their everyday clinical practice. This also reflects our confidence in ex-paxly based on what we are seeing under masking in Solr 1. This is critically important, so let me reiterate. The change in Solr rescue criteria reflects a thoughtful and proactive effort to further bridge the gap between clinical trial design and clinical practice. This is not an FDA requirement, but rather a strategic decision we have made from a position of confidence in ex-paxly's ability to deliver meaningful outcomes in a trial setting that is more clinically relevant for physicians. Solr remains robustly powered at 90% to meet the non-inferiority margin of minus 4.5 letters at week 56 based on our

written FDA feedback and alignment. Let me step back a moment. In

just over one year, we have built a world-class team, advanced a groundbreaking program in wet AMD, and we enrolled in advanced two complementary registrational trials for ex-paxly, all the while maintaining excellent quality, speed, and operational precision. From inception, these trials were intentionally designed to be complementary, not redundant, each addressing distinct yet synergistic clinical questions that together form the foundation of our registrational strategy for ex-paxly. Solr 1 is focused on durability with redosing after the nine-month primary endpoint at weeks 52 and 76. Solr is focused on repeatability of ex-paxly every six months and real-world applicability. Our clinical design strategy for both trials leverages a rigorous screening and loading phase to select the spoke, de-risked patient populations for randomization. This is a critical differentiator and one that we believe could meaningfully reduce patient variability in each trial and strengthen the probability of success in both trials. Together, these trials seek to address the most important questions physicians and patients will have about ex-paxly's durability, repeatability, and flexibility. If successful, these trials may support an unprecedented and potentially the first and only superiority label in retina that enables dosing every six to 12 months in a chronic disease where most patients currently require monthly or bimonthly treatment. Perhaps most importantly, both trials are built on the foundation of FDA alignment with clear guidance around endpoints and trial design and neither study uses sham comparators consistent with FDA's stated preference to avoid introducing bias in past studies. This has been clearly stated in the FDA's guidelines, which they have reiterated in person and in writing numerous times. This thoughtful strategic design gives us confidence not only in our clinical program but also in our ability to bring forward a product that redefines what's possible in retinal disease. Pending successful outcomes, we plan to submit our NDA shortly after the solar 56-week primary endpoint. This strategy allows us to deliver a comprehensive package to the FDA that intends to address durability, repeatability, flexibility, and safety of ex-paxilate. Notably, because ex-citinib is already FDA approved for non-ophthalmic indications, we plan to leverage the 505b2 NDA review pathway which has the potential to shorten the review timeline for ex-paxilate by two months compared to the traditional review pathway for new molecular entities. Moreover, both trials have been designed in close alignment with the latest FDA guidance, SOL 1 under a SPA agreement and SOL R informed by written formal feedback. With a strong clinical and regulatory foundation in place for wet AMD, we're now preparing to expand our reach towards the next horizon, diabetic eye disease. Earlier this year, we received positive FDA feedback on our proposed trial design for patients with diabetic retinopathy. The unmet need here is immense. Despite available therapies, fewer than 1% of NPDR patients are treated. Yet, with ex-paxilate, we may be able to offer a long-acting solution that reduces the risk of progression with just one or two treatments per year. Recall that in our helio study, zero patients developed a vision-threatening complication with a single injection of ex-paxilate 48 weeks compared to almost 40% in the control arm. Additionally, all patients in the ex-paxilate arm that had diabetic macular edema saw improvement at week 48. Although these results are from a relatively small phase 1 study, we believe this is an area where ex-paxilate's profile could drive real change, not just in patient outcomes but also in how retina specialists approach disease prevention. We look forward to sharing more details about our NPDR and DME strategy at our upcoming investor day, which will be held on September 30th in New York City with virtual access available. This will be an important event. We'll walk through how sole trials work together to support what we expect will be a differentiated ex-paxilate label in wet AMD. We'll share new insights on the extension study design for both of our sole trials. We'll introduce our next steps in NPDR and DME, including the clinical trial design informed by recent FDA feedback, and we'll to articulate the global commercial opportunity for ex-paxilate, both in wet AMD and beyond. You can register for our investor day by visiting the events page on the investor relations section of our website. We believe this event will clearly demonstrate the breadth and depth of our strategy and why we believe ex-paxilate is poised to redefine the standard of care in retinal treatment. Let me now turn to our financial position. We ended the second quarter with over $390 million in cash and cash equivalents. In June, we opportunistically raised gross proceeds of approximately $97 million through our existing at the market or ATM facility. Opening the ATM this quarter was a deliberate decision to provide us with maximum financial flexibility as we head into the most significant data readout in Ocular's history. We expect this increased capital will support several key initiatives we'll be speaking more about in our upcoming investor day, including investments in commercial infrastructure, preparation for the Sol 1 and Sol R extension study, and planning for FDA-aligned future studies in NPDDR and DME. Importantly, we remain disciplined stewards of capital. We remain well financed with expected runway into 2028, which is well beyond anticipated top line data readouts for both Sol 1 and Sol R. Our cash guidance does not yet factor in the full impact of potential clinical trial activities for ex-paxilate and NPDDR or the long-term extension study in wet AMD as we remain at the planning phases for these programs. 2025 is already proving to be a breakout year for Ocular Therapeutics. In just the past few months, we have advanced two complimentary registrational trials, aligned with FDA on next steps in diabetic eye disease, and laid the groundwork for commercial readiness in wet AMD. If approved, we believe ex-paxili has the potential to be the first product for wet AMD with a superiority label. This would likely be the only product with a superiority label for the foreseeable future with redosing potentially as infrequently as every 12 months. This profile would provide ex-paxili with a unique and potentially dominant position compared to all other products in the commercial landscape, unlocking an opportunity in wet AMD alone that spans millions of patients worldwide. To summarize the updates from today's call, first, both Sol 1 and Sol R continue to advance with exceptional retention, trial integrity, and physician adherence to protocol, reinforcing our confidence in the quality of data we are generating. Second, in Sol 1, the vast majority of rescue treatments remain aligned with the protocol-defined 15-letter loss threshold. Third, building on this momentum, we plan to incorporate a long-term open label extension study for both Sol trials. This is a strategic effort to potentially generate long-term safety and visual outcomes data with a non-pulsatile treatment that could meaningfully support physician confidence and market adoption. Fourth, we have high confidence in the success of Sol R, and we expect top-line data in the first half of 2027. With a six-month screening and loading phase designed to exclude unstable patients and a primary endpoint at week 56, timed two months after the most recent ex-paxili and aflibiset injections, we believe we have taken steps to de-risk the patient population and maximize the opportunity for success. Fifth, we've streamlined and simplified the Sol R rescue criteria to a greater than five-letter loss plus a greater than or equal to 75 micron increase in central sub-field thickness. We believe this change enhances Sol R's real-world relevance and reflects our continued confidence in ex-paxili. Six, we're preparing to expand into NPDDR and DME. Following positive FDA feedback, we believe ex-paxili could redefine treatment in diabetic eye disease offering durable protection with just one or two injections per year. Seventh, we remain well capitalized with over $390 million in cash and expected runway into 2028, well beyond anticipated top-line data for both Sol 1 and Sol R. Our recent sale of $97 million of common stock under the ATM provides financial flexibility to support both near-term execution and long-term strategic investments. And finally, we look forward to hosting our investor day on September 30th in New York City where we will provide deeper insights into the Sol trials and the Sol trials extension study, our diabetic eye disease strategy, and

our global commercial vision. At Ocular, we're not just developing a drug.

We're redefining the retina experience with confidence, clarity, and conviction. We hope you all plan to join us at our investor day on September 30th. Thank you again for your time and continued support.

Operator, we're now ready to take questions.

As a reminder, if you would like to ask a question, please press star 1 on your telephone keypad. Your first question comes from Byron Amin with Piper Sandler. Please go ahead.

Yeah. Hi, guys. Thanks for taking my questions and congrats on all the progress. I have a multi-part question for Sol R. So, I guess first question, when do you expect a complete randomization of the 555 patients that are required for the trial? Second question, what drove the change in the rescue criteria for the study? And I think you removed the 10-letter loss requirement for the rescue criteria. So, if you could just confirm that. And third, I guess, was there anything on a mass basis that you saw in Sol R that basically drove that change in the rescue criteria? And I guess why was this changed on at this time? So, those are, I guess, the three questions that I have on Sol R.

Thanks. Byron, good morning and thank you for your questions. So, let me just answer that in order. First of all, as far as randomization is concerned, look, we will update you when appropriate. What we've said very clearly is that our enrollment has been completed and that the trial conduct is going superbly. We're very, very happy with the way that the conduct of Sol R and Sol 1, for that matter, is going on. As far as what drove the change, I just want to be very, very clear on this. This modification of the Sol R rescue criteria was based purely for strategic advantage, purely for strategic advantage. It was not required by the FDA and it was based on a position of confidence as far as what we're seeing in the mass data in Sol 1 is concerned. To put it very simply, if you step back and if you look at three studies, and I say three because I include the Sol Extension study, there's a purpose. Again, this is simplistic but it's actually quite effective. There's a purpose for each study. The purpose for Sol 1 is a superiority label. That's very important to us. The purpose for Sol R is clinical use and clinical relevance. The purpose for the Sol Extension study is data generation that supports the superiority label as well as the long-term clinical advantage. What we have done for a position of confidence is to go ahead and modify the rescue criteria for Sol R to better get it towards its goal, which is data generation for clinical use and clinical relevance. Why now? It's really quite simple. It's because of two things. One is, again, it's from a position of confidence. One is because we see the Sol 1 mass data and we're very, very excited by it. We're very confident. Our confidence continues to grow as we see the mass data. The second reason is the feedback that we get from our investigators. What we want to do is we want to set this drug up to be adopted immediately upon its approval. By reflecting rescue criteria that are going on in the community currently will make it much more adaptable immediately and answer all the questions that need to be answered for full acceptance. That's really the reason. Again, this is a decision that's made from a position of confidence and it reflects a strategic advantage that we

will enjoy. Thanks for a question,

Dara. Next question, Tasi Namad with Bank of America. Please go ahead.

Hi, good morning. Thanks for taking my question. Praveen, I just wanted to clarify how you're thinking about any potential for a shortened review timeline given that you're going to file your application after Sol R reads out. If you had any preliminary feedback from the agency or would this be something that you would need to discuss with them and would you need the full Sol R study data in hand in order to get any kind of clarity or could you start a process before that in terms of filing? Secondly, when should we think about the pace with which you'll start for preparing for the potential launch of drugs?

Thanks. So Tazeem, good morning and thank you for your question. First of all, our expectation of what the FDA wants has not changed. The FDA has been very clear in stating that they want two well-controlled, well-masked studies with positive results. They are well aware of what we're doing. You remember that we do have a SPA for Sol 1. We have a written type C confirmation for Sol R. And we expect to be able to submit for approval immediately following a positive result for Sol R, which is at 56 weeks. Now, what we also said was that we do have a drug here that will qualify for a 505b2. Now, remember the typical pathway that most people are used to the 505b1, which is a new molecular entity. This is usually reserved for drugs that have never been approved with drug particles that have never been approved, a drug API that has never been approved. In our case, because XPAC sleep has been previously approved, we believe that the 505b2 path will shorten our time period by at least two months. In regards to launch activities, look, you will be seeing some discussion in our investor day. And I hope everybody will be able to attend our investor day. We will outline for you our outlook in terms of a national as well as a global commercial strategy at that time.

Thank you, Tazim, for your question.

Next question, Tara Brinkhoff with TD Cal. Please go ahead.

Hi. Good morning and thanks for taking the question. So I want to go back to the theme of Biren's questions. So for the updated rescue criteria, can you just help us to better understand how the number and timing of the rescues will be viewed by the FDA when evaluating the primary endpoint for Solr and how that differs from the previous criteria?

Yes, Tara, good morning and thank you for your question. There is really no change whatsoever how the FDA would look at this in terms of the primary endpoint or anything else like that. Again, as I stated earlier on, this modification was based purely on getting a strategic advantage and making this drug immediately adoptable because it reflects what is being done clinically. There is absolutely no FDA requirement whatsoever and we expect no change in terms of the way the FDA regards the

study.

Thank

you.

Okay, great. Thanks so much.

Next question, Colleen Cuffee with Baren. Please

go ahead. Great. Thanks. Good morning. Thank you for your question and congrats on the progress. Understand this change in rescue criteria is not a regulatory decision, but did you speak with the FDA about this change in criteria or would you plan to do so? And then can you just confirm, I think the rescue criteria that you are no longer using is just a pure 10-letter loss with no fluid stipulation? And so how do you think removing that criteria would impact the primary endpoint?

Okay. Yeah, good morning, Colleen, and thank you again for your question. Just like I said to Tara previously, this has nothing to do with the FDA whatsoever. It is a purely strategic decision. It will have no issue whatsoever with the primary endpoint. This is really not an FDA discussion. This is a pure strategic decision that we have made to better reflect the purpose of Solr, which is to completely define this drug to be adoptable immediately for clinical use. There will be, this is again, I'll reiterate, has nothing to do with any kind of FDA requirement. It's a pure strategic decision. Thank you, Colleen.

Got it. That's helpful. And one follow-up, if I can, just from an operational standpoint, I see Solr is already kind of up and running and the change is happening mid-trial. So can you speak to what percent of rescues in Solr were for the criteria and does this change by chance delay the primary endpoint readout?

Yeah, so Colleen, again, this doesn't do anything for the time before the endpoint at all. This does not delay or change the timing of Solr one bit. Recall that one of the great benefits that we have in Solr is the trial design. The trial design is unique in completely de-risking patient population as much as we can. Recall that what we have here is a very -thought-out ramp where we have five loading phase, five loading injections, and we have a unique design in having two opportunities to observe patients for instability. So it's quite a long ramp and it really doesn't change anything in terms of the patient outcomes whatsoever.

Thank you for

your question.

Next question, Kelly Shai with Jefferies. Please proceed.

Congratulations on your great progress and thanks for taking my questions. Maybe for the first one, for the single long-term extension study for both trials, maybe could you explain to us the rationale and the purpose of such design? How much long-term data do you think you need to collect for commercial meaningful impact and also have a follow-up? Thanks.

Kelly, good morning and thank you for your question. It's an important question so let me kind of step back a little bit and answer this in a more holistic way. You know, especially at this time and appropriately, it's important to sort of reflect what these trials are doing and why they fit in and how they fit in. And what I'm about to say, I want to be very, very, very clear. I'm going to talk from a position of confidence. Everything that I've said regarding this drug has been from a position of confidence and my confidence in this drug has not changed one bit and I stand by absolutely everything that I've said. What people ask me often is really what defines success for this drug and people look at numbers as many people do. There's nothing wrong with that and obviously we're very confident about the numbers. We've got to hit the primary end point. We're very confident about the way the clinical trial is going as far as both trials are concerned but in this case, sole one. But really what will define, in my opinion, the real success of this drug is being able to get a security label. And let me explain that. What you see now in this field is really a morass of Me2 drugs and that's based on non-inferiority studies. As far as I know, sole one is the only superiority study that's active and in fact, I don't even know if another superiority study that's planned. So what does that do in terms of the advantage that we would have if we're fortunate enough to get a superiority label? So what I would say is, let me answer that question in terms of the doctor and let me answer that question in terms of the company itself. As far as the doctor is concerned, the doctor wants to be in a position to choose the drug, the best drug possible for the patient. And if there's a pressure based on competition, based on pricing, so on and so forth, and step therapy, the doctor may have to wait until the patient is actually worse on a lesser drug before being able to switch to a better drug or the drug that's desired. And oftentimes what happens in this case, as has been shown in previous diseases in retina, is that the patient really never recovers. There's damage done that's irreversible. Now, why have we extended the sole studies and why have we put in the questions that we want to answer? Well, one of the questions very clearly is what happens to patients when there's a delayed adoption to ex-paxilin? And we want to be able to see if that causes any damage that's irreversible. If there's an advantage, we believe there will be to start an ex-paxilin right away. So from a doctor's point of view, that extension study question is very, very important. From a company's point of view, having a superiority label puts a great deal of value on the drug as well as the company. It puts the drug in an entirely different orbit. Again, I don't know if any other drug that is currently being investigated based on superiority. So getting the superiority label, putting these studies together to answer the proper questions to support that superiority label, particularly the sole extension study, is going to be very important in terms of the value of the drug and value of this company. Thank you for your question.

Super helpful. I also have a follow-up if I may. So besides meeting the regulatory bar for ex-paxilin, two pivotal trials in YAMD, curious, what is the commercial bar in your mind for ex-paxilin to gain dominant position in the YAMD market in terms of how many letters of a BCVA loss from baseline, maybe add 36 weeks or 52 weeks? Thanks.

Yes. So Kelly, it's a great question and it's an appropriate question. Thank you for the question. First of all, look, the most important thing for us to do is to conduct a study in a way that we will allow this drug to show itself. And we're very, very firmly committed to doing that. And our confidence in this drug has always been great and continues to grow every day. In terms of meeting the primary endpoint, that's what we have to do. From that point on, what we intend, we'll have a lot of data. And what we intend to show is data that will show a clear profile of this drug. We'll have data regarding the Delta, we'll have data regarding the visual acuity, regarding anatomy, so on and so forth. And what we also intend to do is to show the data in a way that maximizes the confidence in the translation of a positive SOAR-1 study to SOAR. We realize how important that is, and I hear that. It is very important, although we realize that the patient population is different in a bespoke manner and intentionally so, the drug is the same. And I totally get the fact that when we show the positive SOAR-1 data, it has to be shown in a way that allows you and everybody else to be very confident the translation of that success to SOAR, and we will do that. So based on all of those things and based on us having the potential to get a superiority label, I think we'll have more than enough data that physicians can look at the culmination of all the results that are there and say, this is a drug that will be translatable to the way I go ahead and treat my patients. And the superiority label allow me to make sure that I can use this the way I want to use it for my patients and that drug will be protected. That's the important part. Thank you, Kelly.

Sean Makachian with Raymond James. Please go ahead.

Hi, thanks for the question. And just picking up on that last point for Vien, can you speak to the impact of having 12 month follow up for SOAR-1 as a re-thrower to SOAR and whether you anticipate having visibility into a meaningful proportion of patients out to say 15 or 18 months on SOAR-1 at that point to get a read on the impact of re-dosing? Thanks.

Thank you. It's a great question. I appreciate the question. You know, I think, as I say, we will be providing, we'll have a lot of data right away and we'll be providing data in a way that we will absolutely head on address that issue. As of now, I can't tell you that we've advised you to what data we'll be providing, but look, I hear you. I hear everybody, the company hears everybody and saying, we need to provide you with that link from SOAR-1 to SOAR. We're absolutely going

to be set up to do that. Thank you for the question.

Next question, Lisa Walter with RBC Capital Markets. Please proceed.

Good morning. Thanks so much for taking our questions. Maybe a first one on SOAR-1. Just wondering if you can clarify a detail for us on off protocol rescues. You know, for the on protocol rescue injection criteria, very clear that patients must lose 15 letters or more, but wondering where patients who have hemorrhage fall into, whether they fall into the ophthalmology or the off protocol or on protocol rescue criteria.

Yeah, good morning, Lisa. Thank you for your question. Look, in every single study and having done clinical trials for 30 years before this job and the job before, what I'll tell you is that in every single clinical trial, there's a section there that says that the patient may be rescued per the doctor's discretion, and that has to be there to pass the IRB. That is to protect the patient. And the doctor can rescue the patient based on his or her decision if they feel that that is the safest thing for the patient. As far as the protocol for SOAR-1 is concerned, it clearly states that the primary endpoint is based on the rescues, and the rescues consist of 15 letters or more of loss of vision or any kind of hemorrhage that threatens the macula. Now what I will say and what we've been saying over and over again is that the vast, vast majority of patients here are being rescued based on the loss of 15 letters of vision and the protocol is being followed. And that's very important. Thank you, Lisa, for your question.

Next question, Yi Chen with HC Wainwright, please proceed.

Thank you for taking my question. Could you please remind us what was the rescue criteria for SOAR before the change and how do you expect the change to impact the number of patients being rescued? And also, could you comment on whether there was a change in real world practice in terms of rescue criteria during the past several years? Thank you.

Yes, so thank you for the question and good morning. So, as I say, the reason that we made the changes, I keep saying, is that it was made purely for strategic reasons. There was no FDA issue whatsoever. As far as the practice patterns are concerned, what I can tell you is when we spoke with the RPIs and when we saw what we saw based on a MAST basis with SOAR-1, we felt that we did not want any questions whatsoever as to the relevance of the rescue criteria. We wanted to make it as liberal as possible because we were very confident in the drug. And remember, we have a patient population here that is de-risked and selected after a six-month loading phase with two opportunities to observe for instability. So we will be randomizing patients that we feel are about as de-risked as we can have them. Based on the ramp that we have. So having seen what we've seen and having heard the PIs, our decision was to say, you know, we have enough confidence in this drug now that we can go ahead and allow the rescue criteria to be as liberal as possible so there'll be no question in terms of adoption whatsoever. Again, it was made purely for that strategic reason and we believe that that will allow for a

significant strategic advantage. Thank you for your question.

Next question, John Wallenbein with CitizensJMP. Please proceed.

Hey, thanks for taking the questions, Pradeem. Just kind of piggybacking on the same rescue criteria theme. You mentioned kind of the investor feedback and the read through from the SOL 1 to SOL R criteria, but you know, the criteria is different. So wondering what was the specific feedback you received to prompt this change? And then a second one, you mentioned your expectation was in line on SOL 1 for the cadence of rescues. Wondering, what is your expectation for the cadence of rescues for ILIA versus ExPAC, actually? Thanks.

Yeah, John, good morning and thank you for your questions. So again, going back to the rescue criteria, the feedback, you know, really we got was very, very simple. It was, look, I want this drug. I want this as soon as it's out there and I want to make sure that my rescue criteria now in terms of what I do for patients is aligned with what I see from SOL R. And, you know, people have different rescue criteria in real life, but we wanted to make it so that even folks that will be rescuing based on the most liberal of criteria are able to basically have a translation directly from SOL R. And again, this reflects our level of confidence in this drug that we see in amassed fashion. As far as your question regarding the cadence of rescue and SOL 1 is concerned, let me go back to what we're looking at. We're looking at three things as I've said. The first one is the number of rescues. We're looking at the cadence of rescues, which means that we want to make sure that we see a pattern of rescues that we expect. And we absolutely do. We have great confidence that we're seeing the kind of rescues that we would expect, again, in amassed fashion. And the third thing that we look for is we look to make sure that these rescues are being done on protocol and on all three of those parameters, we are very, very, very happy and we continue to see a consistency in those patterns, as I've said, from the very beginning that gives us a great deal of confidence in the results of SOL R.

Thank you for a question.

Greg Harrison with Scotiabank. Please go ahead.

Hi, everybody. This is Joe Thomas. I'm for Greg Harrison. Thank you for taking our question. Just one based on the updates today. Just how should we and investors be thinking about the interplay of the eventual time to market for ex-Paxly with the potential superior label to competitors who might possibly enter the market slightly sooner? Thank you.

Yeah, good morning and thank you. You know, look, I keep on emphasizing that that's one thing that I think is really quite underappreciated, which is the position that we will potentially have with a superiority label. Again, I'll reiterate each kind of just kind of step back and look at this market. Every drug is based on a non-inferiority study. The difference between these drugs are very slight, if any at all. And when you have a situation like that, when you have a morass of drugs that pretty much look the same, the competition is basically based often on pricing with very little to distinguish the drugs. And as someone who's practiced for 30 years, I realized that the downstream pressures of something like that and the downstream pressures of something like that is that the relationship that a doctor has with a patient is taken away or at least impacted. Because the choices that are made for the drug are being forced to be made based on pricing. And oftentimes the consequences of that are really very bad for the patients. Again, we have studies in chronic diseases and retina where if the patient is started on the proper drug in a delayed fashion, the vision never recovers. The vision may improve, but really never recovers to the extent that it should have been. And again, as I said earlier on, this is a major point of study for extension, our sole extension study. We will have unique data there where we're able to see what happens to patients who are started on OXPACS after a two-year delay. We'll have an opportunity to see if that catches up or not. And when we see something like that happening where there's irreversible visual loss from a delay in treatment, that has a tremendous impact on patients chronically. So with a superiority label, our expectation is that we'll be in a different orbit. We will be immunized from the rest of the drugs and the rest of the pressures that they may feel. This will add a great deal of value to the drug, to the company, and most importantly, we believe that this will allow for better patient care and better long-term outcomes. Thanks for the question.

Next question, Lachlan Hanbury Brown with William Blair. Please proceed.

Hey, thanks for the question. I was curious on the reason for starting the overlap extensions now versus having them up and running previously. Praveen, you mentioned that you've obviously been in the space for a while, seeing the data from all these studies showing long-term benefits. So knowing the value that that can provide, like, why did you not originally start them? Why did that change now?

Again, thank you. Good morning and thanks for a question. There's really no reason other than a logistic. At a certain point, you start these studies with what you see under masking, again, with a great deal of confidence, and you step back and say, what questions can we answer with this drug? And what questions would be most clinically relevant to be answered? And that's the questions that we're asking. Again, we'll have a lot more detail regarding what the extension study will look like. And further questions that we'll be asking in the extension study in our investor day on September 30th.

Thank you for the question.

Bill Maughan with Clear Street, please go ahead.

Good morning and thanks. So you mentioned excluding patients with high fluctuations in the OCP from the trial to reduce noise, which makes sense. But just looking down the road, do you expect any impact on the commercial effort? Either by a restrictive label discussing excluding these patients or just understanding among the prescribing community that these patients were excluded from the trial. Thank you.

Yeah, good morning and thank you for the question. No quite the opposite, quite honestly. So let's just speak from the doctor's point of view as well as from the label point of view. From a physician's point of view, what we're providing is a pure patient population by reducing the noise. We're actually providing much more valid scientific data. So from a physician's point of view or a clinician's point of view, the data that we're providing by providing a pure scientific patient population provides for a pure comparison. So quite the opposite as far as a clinician is concerned. From a labeling point of view, that's never ever been the case. And the most recent example that I have from a personal viewpoint is my last company. In Iverick Bio, the same question was asked about label restrictions. If you recall, all the studies were done with patients with extra-fovial geographic atrophy. In fact, not a single patient with phobia involving geographic atrophy was ever studied. And this question was always brought up. And as you can see in the label, there are no restrictions at all. And there are numerous examples of that going all the way back to Anker and Marina and visual acuity restrictions in terms of patient enrollment to panorama, for instance, looking at diabetic retinopathy in only a certain group of patients. So history has shown that as long as you conduct a proper scientific study that's well-masked, well-conducted, there really will be no label restrictions. Thank you for your question.

Surge Ballinger with Needham and Company, please go ahead.

Hi, good morning. This is John on the surge today. Congrats on all the progress for being. Just to touch on again the translation of SOLAR data, the SOLAR, considering the distinct purposes and criteria, you know, for each trial. Do you view the readout of SOLAR as a de-risking event for SOLAR or more so a complimentary considering they're answering different questions?

Good morning and thank you for your questions. It's a great question. So what I will tell you is look, it's clearly both. Again, I'll repeat this. I know there's a great deal of interest in looking at the SOLAR results and seeing the translation into SOLAR. That in my mind is completely appropriate and understandable. The patient populations are deliberately different. The drug is the same and we will address that. I hear you. I appreciate it. We will address that in the data cuts that we will release to give you confidence in the translation of a positive SOLAR study to SOLAR. Now having said that, I will also say that there are several two important things that are right in front of you that should give you a great deal of confidence. One is the patient selection and the other is the clinical trial design. As far as patient selection is concerned, look, every single anti-VEGF study that I know looks the same. After two or three injections, visual acuity stabilizes. Every single one of them and the curve looks exactly the same no matter what the anti-VEGF agent is. We're going well beyond that. We're injecting five times prior to randomization. Not only are we doing that, but we have two unique windows, two opportunities to look for instability. The patients that we're randomizing are about as de-risked as we can make them. That in itself should give a great deal of confidence in terms of patient selection. The second thing in regards to clinical trial design, remember that our primary endpoint is at week 56. It's a singular endpoint. It's not a blended endpoint. It's a singular endpoint. This, in our opinion, is an optimal endpoint because it's two months after the last expaxel injection and the last aflibisat injection. Given those two things, you already should have quite a bit of confidence in the success of SolR. But having said that, I completely understand and hear that the SolI positive results will have to allow you to translate that success into SolR. We hear you,

we understand you, and we intend to address that.

Thank you for your question.

This concludes our question and answer session. I will now turn the call back over to Dr. Praveen Dougal for closing remarks.

Thank you very much. Once again, I'd like to thank everyone

for taking the time to join our call today. We look forward to updating you on our progress. If you have any follow-up questions, please contact Bill Slattery, our Vice President of Investor Relations. Please also register for our Investor Day. Have a great day, everybody. Thank you.

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.