EyePoint, Inc.

Good morning. My name is Antoine and I will be your conference operator today. At this time, I would like to welcome everyone to the iPoint third quarter 2025 financial results and recent corporate developments conference call. There will be a question and answer session to follow at the completion of the prepared remarks. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to George Elston. Executive Vice President and Chief Financial Officer of iPoint. Please go ahead.

Thank you, and thank you all for joining us on today's conference call to discuss iPoint's third quarter 2025 financial results in recent corporate developments. With me today is Dr. Jay Duker, President and Chief Executive Officer of iPoint. Jay will begin with a review of recent corporate updates and discuss our clinical programs for door review in wet AMD and DME. I will close with commentary on the third quarter 2025 financial results. We will then open the call for your questions where we will be joined by Dr. Ramiro Ribeiro, our chief medical officer. Earlier this morning, we issued a press release detailing our financial results and recent corporate developments. A copy of this release can be found in the investor relations tab on the company website, www.ipointpharma.com. Before we begin our formal comments, I'll remind you that various remarks we will make today constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. These include statements about our future expectations, clinical developments, and regulatory matters and timelines, the potential success of our products and product candidates, financial projections, and our plans and prospects. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the risk factors section of our most recent annual report on Form 10-K, which is on file with the SEC, and in other filings that we have made or may make with the SEC in the future. Any forward-looking statements represent our views as of today only. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change. Therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today. I'll now turn the call over to Dr. Jay Dugard, President and Chief Executive Officer of I-Point.

Thank you, George. Good morning, everyone, and thank you for joining us. I am pleased to discuss with you today the tremendous progress we've made during the past quarter, continuing our strong track record of execution. As you will hear, our momentum underscores our confidence in the differentiated clinical profile of DuraView, our lead program, and its potential to transform the treatment paradigm into two largest retinal disease markets, wet H-flated macular degeneration, or wet AMD, and diabetic macular edema, or DME. I'd like to start with a brief overview of our recent highlights. DuraView is on track to be the first to file and first to market among all current investigational sustained delivery wet AMD and DME programs, positioning DuraView at the forefront of the treatment landscape with potential first mover advantage. We completed enrollment of the Lucia trial the second phase three trial for DuraView and WET-AMD in July. Both trials, Lugano and Lucia, were enrolled in seven months and together recruited over 900 patients, making them among the fastest enrolling WET-AMD pivotal programs to date. Top line data for DuraView and WET-AMD is expected in mid-2026. Following the positive end of phase two meeting in July for DME, We were pleased to align with the FDA on a non-inferiority trial design that we believe is clinically rigorous, efficient, and de-risked. As a reminder, DuraView is the only tyrosine kinase inhibitor, or TKI, in development for DME. We are rapidly moving forward with a pivotal phase 3 DME program with first patient dosing expected in Q1 2026. The Phase III DME trials, COMO and COPRI, will leverage our existing wet AMD clinical trial infrastructure and our enthusiastic network of investigators. We announced new preclinical data showing that virolinib The active drug EnduraView is unique among TKIs being tested in retinal diseases as it inhibits both VEGF-mediated vascular permeability and interleukin-6 or IL-6-mediated inflammation. This multi-mechanism of action has the potential to be particularly effective in the treatment of multifactorial diseases such as wet AMD and DME. These new data underscore the impressive Phase II results of the Verona trial and DME, and strengthened our confidence in our clinical programs. Finally, our path to potential success in Phase III is supported by our strong balance sheet. We ended September 2025 with over $200 million in cash and equivalents, and closed a $172 million follow-on offering in October. Our cash is now expected to fund operations into Q4 2027, well beyond Phase 3 wet AMD data anticipated in 2026. With this continued exceptional track record, iPoint will enter an eventful 2026 from a position of strength. Now, I'd like to take a closer look at the current market landscape for wet AMD and DME. With a combined current global market of $10 billion and growing, these indications make up the vast majority of the global branded retinal disease market. Despite the size and scale of these diseases, they are dominated by a single treatment modality, monotherapy anti-VEGF biologics. Due to the high burden of frequent injections, many patients remain undertreated, even with the addition of recently approved extended duration options. Additionally, these current standard of care anti-VEGFs demonstrate subpar real-world efficacy in DME, with growing literature supporting the role of not only VEGF activation, but also IL-6 signaling and inflammation driving disease severities. We believe our lead product candidate, DuraView, is well-positioned to deliver much-needed innovation in both wet AMD and DME. As a differentiated, sustained-release TKI, DuraView is designed to improve the current standard of care by providing durable disease control while reducing the treatment burden. Further, DuraView's potential multi-MOA blocking VEGF, PDGF, and IL-6 signaling may be uniquely suited to effectively address multifactorial retinal diseases such as DME and wet AMD. Beyond its unique MOA, DuraView offers a compelling product profile that supports strong competitive positioning in both wet AMD and DME. Unlike other sustained release options in development, DuraView is formulated in R DuraCert E technology. a bioerodible sustained-release insert specifically designed to prevent free-floating drug particles. Additionally, DuraView is shipped and stored at ambient temperature and administered via a standard intravitreal injection. DuraView features the most robust clinical data package among all investigational sustained-release programs. This includes Phase II wet AMD and DME data, demonstrating meaningful visual and anatomic improvements from a single Duravu dose and a consistent and favorable safety and tolerability profile with no safety signals observed in over 190 patients across four completed clinical trials. Given its advantageous clinical profile, multi-target MOA, and unique storage and administration conveniences, we are confident that the review offers a differentiated value proposition that is meaningful to physicians and patients and, if approved, would present a compelling option within the current and future landscape for retinal disease treatment. Let me now walk through recent updates for our Phase III programs, beginning with wet AMD. Our fully enrolled Phase III pivotal program remains on track to deliver top line data starting in mid-2026. As a reminder, in July, we completed enrollment of the Phase III program with over 900 patients randomized across the two trials. To ensure we are positioned for commercialization, we are highly focused on our manufacturing capability and CMC submission for an NDA. We have already produced the review registration batches at our state-of-the-art GMP compliant manufacturing facility in Northbridge, Massachusetts. The 41,000 square foot facility was built to both US FDA and EMA standards and will have capacity to support the commercial launch. Moving on to the recently initiated phase three program in DME, our program consists of two non-inferiority trials, COMO and COPRI. evaluating Duravue 2.7 milligrams versus on-label Aflibercept control. Each trial will enroll approximately 240 patients. Additionally, given the established non-inferiority pathway, as well as our ability to leverage our existing Phase III clinical trial infrastructure, we believe the program is significantly de-risked. We look forward to dosing our first patient in Q1 2026. As I mentioned earlier, there is growing clinical evidence supporting the multifactorial nature of retinal vascular diseases with both VEGF-mediated vascular leakage and inflammation contributing to disease pathogenesis. IL-6, a pro-inflammatory cytokine, is a key driver of this inflammation and is found at significantly higher levels in DME and wet AMD patients versus healthy individuals. Recent preclinical findings, which we presented at the American Academy of Ophthalmology meeting in October, demonstrate that virolinib, the active ingredient in DuraView, inhibits IL-6 signaling through JAK1 receptor blockage. In addition to its known inhibition of PDGF and all VEGF receptors. In vitro data shows a meaningful reduction in IL-6 activity of more than 50% with virolinib, suggesting a multi-MOA capability. This data may explain the rapid fluid reduction in vision improvements observed as early as week four in the Duravu arms in the phase two Verona trial. In summary, We are well-positioned to extend our clinical leadership in sustained-release therapy for the two largest retinal disease markets. We remain focused on reporting top-line Phase III data for both Lugano and Lucia starting mid-next year, positioning DuraVute to be the first to file and potentially first to market among all investigational sustained-release programs in wet AMD. Our Phase III DME program is now underway, and we expect first patient dosed during the first quarter of 2026. We are moving swiftly and confidently to bring DuraView to patients in need, while continuing to ensure our progress follows a de-risked, clinically rigorous, and patient-centric approach. Before passing it over to George to review our financials, I want to thank the entire iPoint team for your dedication to improving patients' lives through better vision, as well as the patients, study coordinators, and clinical investigators outside of our organization who enable our clinical research. We are grateful for your confidence, and we are proud to advance our therapeutics for the benefit of the entire retina community. We look forward to continued progress towards our upcoming milestones as we further our leadership in sustained ocular drug delivery. I will now turn the call over to George. George?