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