EyePoint, Inc.

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

Thank you, and thank you all for joining us on today's conference call to discuss iPoint's fourth quarter and full year 2025 financial results and 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 DuraView and wet AMD and DME. I will close with commentary on the fourth quarter and full year 2025 financial results. We will then open the call for your questions where we will be joined by Dr. Romero-Ribero, our chief medical officer, and Mike Campbell, our new chief commercial officer. Earlier this morning, we issued a press release detailing our financial results and recent corporate developments. A copy of the release can be found in the investor relations tab on the company website www.ipoint.bio. 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 Duker, President and Chief Executive Officer of I-Point. Thank you, George.

Good morning, everyone, and thank you for joining us. 2025 was defined by significant progress and achievement for iPoint as we made important advances that set the stage for success and potential value creation for the year ahead. As a result of our exceptional clinical execution, driven by our de-risked and patient-centric programs, our lead asset, DuraView, is on track to deliver top-line data in wet H-related macular degeneration, or wet AMD, beginning in mid-2026. In parallel, we advanced to review as the only tyrosine kinase inhibitor, or TKI program, in diabetic macular edema, or DME. We are pleased to report that as of last week, the first patients were dosed in both pivotal phase three DME trials. With a strong cash position that is expected to fund operations into the fourth quarter of 2027, and multiple inflection points on the near-term horizon, we are entering a transformative period for iPoint with significant momentum. Our conviction in DuraView's blockbuster potential is underpinned first and foremost by its compelling clinical profile. In our phase two trials in the largest retinal disease markets, a single dose of DuraView demonstrated durable efficacy with improved vision and tight anatomical control. Importantly, DuraView has a favorable safety profile with no safety signals in over 190 patients across four completed clinical trials. The safety trial so far remains consistent, in the ongoing phase three Lugano and Lucia trials for wet AMD based on continued masked internal safety review and two interim reviews conducted by the independent data safety monitoring committee. In addition to its robust clinical profile, we continue to believe that the potential for every six month dosing via standard in-office intravitreal injection, a best in class delivery technology and a novel multi-MOA that inhibits VEGF, PDGF, and IL-6 via the JAK1 receptor with no TIE2 inhibition are the key drivers of its differentiated profile. This unique profile positions Duravue to address both VEGF-mediated vascular leakage and IL-6-mediated inflammation that contribute to disease pathogenesis in wet AMD and DME, thereby potentially enabling improved long-term outcomes for patients with fewer injections. Our confidence is also grounded in our established and clinically rigorous approach throughout DuraView's development. Our Phase III wet AMD program was intentionally designed to inform real-world practice and generate meaningful data for the retinal community by comparing DuraView to on-label of Flibrosept as the control. Additionally, we will be evaluating statistical superiority in treatment burden reduction and six-month redosing to support a compelling and relevant label. Based on the success of our large Phase II W02 trial and with our proven regulatory pathway and strong execution to date, we believe our WET-AMD program is uniquely de-risked and optimized to support success. We look forward to reporting top-line data beginning in mid-2026. The clinical and regulatory rigor that defines our approach also extends beyond WET-AMD, as we work to position DuraView for multiple indications. We are pleased that randomization is now underway for both COMO and COPRI, our two pivotal phase three trials in DME, where we expect to drive rapid enrollment by leveraging our pre-existing clinical trial infrastructure and investigator network. In line with our WET-AMD program, our DME program follows an established non-inferiority design, with an on-label standard of care control and redosing every six months. It was similarly informed by impressive Phase II data from the Verona trial, where eyes treated with DuraView demonstrated meaningful visual and anatomic improvements as early as four weeks. We anticipate top-line data in the second half of 2027. and look forward to building upon our strong track record of clinical execution as we advance DuraView through our Phase III DME program. We believe that DuraView is well positioned to be the first to market among all current investigational sustained release programs in both wet AMD and DME with a potential best-in-class profile. And we remain focused on building DuraView into a durable franchise targeting the largest retinal disease markets. With a combined current global market of $10 billion and growing, wet AMD and DME make up the vast majority of the global branded retinal disease market. Duravu's unique MOA, robust clinical data package, proven release technology, and attractive storage and administration benefits offer a compelling value proposition that we believe will address the longstanding need for innovation and support strong commercial positioning. As part of our ongoing commercial readiness efforts, we are thrilled to welcome Michael Campbell as our new chief commercial officer. Mike is a seasoned commercial leader with a proven track record of successful product launches and oversight of prominent ophthalmology franchises, including Lucentis and Zydra. As we prepare to deliver on iPoint's next milestones, including potential approval and transformation into a fully integrated commercial organization, Michael's deep commercial expertise will be instrumental as we position to review for a successful US launch. In addition to strengthening our commercial leadership, we continue to expand operations at our 41,000 square foot CGMP manufacturing facility in Northbridge, Massachusetts. The facility has been online for over a year, supported by about 60 full-time employees, and continues to not only support the CMC submission for our planned new drug application, or NDA, but also commercial supply. As we near regulatory submission, we are preparing for pre-approval inspection, underscoring our growing independent commercial readiness and commitment to ensuring that we are well equipped to deliver DuraView to patients if approved. Before passing it over to George to review our financials, I'd like to thank the entire I-Point team for your continued dedication to improving vision and patient outcomes. We are proud to advance our therapeutics for the benefit of the entire retina community and grateful to the patients, study coordinators, and clinical investigators who make our research possible. As we look ahead, we are excited about the upcoming milestones and the opportunities in store for us to extend our leadership in sustained ocular drug delivery. I will now turn the call over to George.