Ocular Therapeutix, Inc.

Please stand by, your program is about to begin. If you need assistance on today's program, please press star zero. Good morning and welcome to the Ocular Therapeutics second quarter 2024 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 one. As a reminder, this conference call is being recorded. 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 please go ahead mr slattery good morning everyone and thank you for joining us today earlier this morning we issued a press release outlining our financial results for the second quarter 2024. make the best use of your time today

Oculus Executive Chairman, President, and CEO, Dr. Praveen Dougal, will briefly provide a summary of recent business highlights so we can quickly get to your questions. Joining Dr. Dougal for the Q&A portion of the call will be Donald Notman, Chief Financial Officer, Dr. Nadia Waheed, Chief Medical Officer, Dr. Sanjay Nayak, Chief Strategy Officer, and Steve Myers, Chief Commercial Officer. We refer everyone to this morning's press release in our Form 10-Q for a comprehensive update of second quarter financial and business results. During today's call, we will be making certain forward-looking statements, and our actual results may differ materially. Please see the risk factors section of our annual report on Form 10-K and our other SEC filings for details on the risks and uncertainties relating to our business. With that, I'd like to hand the call over to Dr. Praveen Dugal to review our recent updates. Praveen?

Thank you, Bill, and thank you to everyone for joining us today. We know this is a very busy time of year for everyone, so let's jump right in. When I assumed responsibility as Ocular's Chairman of the Board, President, and CEO in mid-April, the goal was simple. Transform this organization into a retina-focused company and execute, execute, execute. Ocular's number one priority today is to bring Xpaxily to market for wet AMD as soon as possible, given the large market size and the unmet need, both in terms of the need for a more sustainable treatment option and the need to improve long-term outcomes. As of this morning, we can now confirm that the FDA has advised us that the two wet A&D studies in which we are currently enrolling patients, SOL1 and SOLAR, are both appropriate as registration enabling studies. This is a momentous achievement for the ocular team that has been working diligently to surpass all expectations. In a few short months, this team has achieved four tremendous accomplishments that I'd like to outline today. First, we set a decisive vision for the company and streamlined the organization. This year we've invested in the areas of the business that are most value creating and are aligned with our vision to be a leading retina company. We've invested in highly credentialed retina experts with unmatched experience in clinical development regulatory affairs, biostatistics, and other key functions. To put this dream team in context, members of the ocular team have played a role in nearly every major advancement in retinal diseases over the past three decades. We are fortunate today to be well financed with approximately $460 million in cash at the end of the second quarter. Based on our current operating plans, we believe this gives us a cash runway into 2028 beyond the anticipated top line readouts for both the SOL1 and SOLAR studies in wet AMD. Our commitment to the investment community is to stay financially disciplined, which included making the difficult decision earlier this quarter to reduce headcount in areas of the business that are not aligned with the vision of the company. Our second significant accomplishment relates to the SOLE-1 study, where the rate of enrollment continues to accelerate and exceed our expectations. SOLE-1 is the first of two registration studies for XPACs late and wet AMD. The single biggest challenge I saw when I first came to Ocular was how to effectively communicate the benefits and advantages of the SOL1 study to the retinal community as well as patients. In our June Investor Day, we shared the success of our communication campaign by announcing that 60 sites had been activated and over 150 patients were in various stages of loading and randomization. As many of you know, Enrollment in clinical trials is not always linear. When you hit a critical mass of sites activated, enrollment starts to accelerate in an exponential fashion. And today, we believe we're in that exciting phase of enrollment in the SOLE1 study. In short, we continue to be delighted with the enrollment following our Investor Day announcement. The third substantial accomplishment is the initiation of our repeat dosing study, SOLAR, or wet AMD. Over the course of just three months, the ocular team developed the concept for SOLAR, activated study sites, and as of last week, began enrolling patients. To take it one step further, we can now share that the FDA has officially confirmed to us in writing that SOLAR is acceptable as a registrational study for Ax-Paxley in wet AMD. Let me say that again. SOLAR was taken from concept to clinic in just three months. This is simply exceptional, and in my experience, unprecedented. When we talk about SOL1 and SOLR, what's most important for everyone to understand is how well these studies complement each other and how much thought has gone into patient selection and study design to reduce disease variability, de-risk the patient population, and improve the likelihood of a successful outcome in both pivotal studies. The bottom line is when taken In its totality, SOLAR-1 and SOLAR are designed to meet our regulatory requirements while providing commercially meaningful data. The fourth accomplishment is the presentation of results from our Phase I helio study in non-proliferative diabetic retinopathy, or NPDR. What's remarkable about these results is that every single metric and parameter favored X-Paxley. These data show that with a single X-Paxley implant, literally zero patients in the trial were observed to have developed vision-threatening complications at 48 weeks versus the 20 to 30% year-over-year historic rates. In other words, not a single patient after a single injection of Xpaxly developed a potentially blinding complication after 48 weeks. These impressive results have been well noted by our retina colleagues. In fact, they were viewed as significant enough to warrant a late-breaker presentation at the recent ASRS meeting. We believe the positive initial data from Helios not only provide us a remarkable opportunity in NPDR, but also build on our U.S. and Australia studies in wet AMD, giving us further database confidence for the success of both the SOL1 and SOLAR pivotal studies. As we conclude the prepared remarks in today's call, I'd like to leave you with these key messages. We are dedicated to becoming a leader in the treatment of retinal disease and improving vision in the real world. We have assembled an expert retina team to accelerate the development of X-PACs late for wet AMD, which now includes two registration enabling studies that are enrolling patients. We have very thoughtfully designed both SOL1 and SOLR with an emphasis on enriching the patient selection appropriately for each trial and on de-risking each study to improve the probability of success. SOL1 and SOLR are strategically designed to provide meaningful data for both regulatory and commercial purposes. We are executing extremely well, exceeding our highest expectations based on the enrollment pace for Sol 1 and the rapidity of initiation of enrollment in Sol R. And we believe, based on our current operating plans, that our cash runway takes us into 2028 and fully funds Sol 1 and Sol R top-line results. We look forward to updating you on our progress with the sincerest thanks for your engagement and ongoing support. Operator, I would now like to open the call for questions.