EyePoint, Inc.

Good morning. My name is Antoine and I'll be your conference operator today. At this time, I would like to welcome everyone to the iPoint second quarter 2025 financial results and recent corporate developments conference call. There will be a question and answer session to follow 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.

Thank you, and thank you all for joining us on today's conference call to discuss iPoint's second quarter 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 the ongoing clinical trials for Duravue and WED-AMD. I will close with commentary on the second quarter of 2025 financial results, and we will then open the call for your questions. Earlier this morning, we issued a press release detailing our financial results and recent corporate developments. A copy of the release can be found on 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 may 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. I am delighted to discuss with you today our key second quarter updates highlighted by the impressive progress of our Phase 3 clinical program for our lead asset, Duravue, in wet age-related macular degeneration, or wet AMD. Since January 2021, when the first patient was dosed with Duravue in our Phase 1 Davio trial, our diligent focus and exceptional execution across all fronts has brought us, in just over four and a half years, to full enrollment in both of our phase three pivotal trials in wet AMD. A testament to iPoint's leadership in drug development and commitment to serving the retinal community. Before discussing the specifics of the past quarter, I'd like to reflect on how far we've come as a company over the short period. We successfully and efficiently pivoted to a clinical stage biopharmaceutical company prioritizing the development of DuraView as a new treatment paradigm in the two largest retinal disease markets, wet AMD and diabetic macular edema, or DME, while exiting the specialty pharma business. We completed four clinical trials for DuraView, including three phase two trials, treating over 190 patients with DuraView across multiple retinal indications. establishing a robust and favorable safety profile that is cited by physicians as a key motivator for their eager participation in our pivotal program. We've generated the most comprehensive data set among current sustained release therapies in development for wet AMD, establishing truly compelling phase two efficacy data, demonstrating statistically non-inferior visual acuity compared to on-label of Flibercept, while reducing treatment burden by over 80%. Bolstered by this robust efficacy profile, outstanding safety, and a patient-centric pivotal trial design, we completed oversubscribed Phase III enrollment in record time for this indication, with over 800 patients enrolled across the Lugano and Lucia trials. Thanks to rapid enrollment and efficient trial design, we are well positioned for top-line Lugano data in mid-2026, with Lucia top-line data anticipated shortly thereafter, a timeline that we believe positions us to be first to file and potentially first to market among the current investigational sustained release therapies for wet AMD. We also expanded the database underpinning DuraView's differentiated clinical profile beyond wet AMD, reporting highly positive results in the Phase II Verona trial in DME, supporting a pivotal program in this second blockbuster indication. In anticipation of potential commercial success, we built a state-of-the-art 41,000 square foot CGMP manufacturing facility in Northbridge, Massachusetts to support commercial production of DuraView with registration batches currently underway to support an anticipated NDA filing and eventual pre-approval inspection. Finally, we transformed our balance sheet by eliminating debt and extending our cash runway into 2027 well beyond pivotal wet AMD data in 2026. I am incredibly proud of the pace and quality of these achievements, and we have no intention of taking our foot off the gas. Now, for a closer look at wet AMD, this is a $10 billion market and growing in the United States, currently dominated by a single treatment modality, monotherapy with anti-VEGF biologics. While efficacious, Patients with wet AMD still tend to lose vision in the long term. Newer options intended to provide up to four months of visual stabilization in some patients still have similar limitations and often require significantly more frequent injections to maintain stable vision. In light of these drawbacks, improved durability remains the most important factor for physicians when choosing a wet AMD therapy. and represents an area of much needed innovation. Our lead product candidate, DuraView, presents a compelling treatment paradigm shift, paired with a new mechanism of action to meet this need. Backed by durable efficacy of at least six months and a consistent and favorable safety profile, coupled with unique storage and administration advantages, we believe DuraView offers a differentiated product profile that is meaningful to physicians and patients, and if approved, would facilitate strong competitive positioning in the wet AMD treatment landscape. Let me now walk through the key attributes underpinning DuraView's differentiation. First, DuraView is not another anti-VEGF biologic or ligand-blocking therapeutic like the approved products on the market. It's a clinically validated sustained release tyrosine kinase inhibitor, or TKI, that brings a new mechanism of action that may complement existing anti-VEGF biologics to offer more durable disease control and a reduced treatment burden. DuraView is comprised of the potent and selective TKI, Virolinib, which works intracellularly to inhibit all VEGF receptors as well as the PDGF receptor. formulated in our bioerodible DERISR-E technology. DERISR-E is a next-generation bioerodible sustained release insert with a matrix designed to prevent free-floating drug particles that contains no PEG and no PLGA. Second, unlike other sustained delivery therapies in development, DERIV-U is shipped and stored at ambient temperature. Consistent with current practice, DuraView is administered in the physician's office with a standard intravitreal injection and comes in a preloaded sterile syringe injector. Most importantly, through its novel mechanism of action, DuraView can potentially deliver stable vision and retinal anatomy when dosed every six months, a cadence that should support improved compliance over the long term for wet AMD patients. The clinical data generated to date indicates that DuraView has the potential to meaningfully change the wet AMD treatment paradigm. And we designed our Phase 3 program to validate this through a clinically rigorous but de-risked approach. Our Phase 3 Lugano and Lucia trials are double-masked, non-inferiority trials designed in close alignment with the FDA, including written agreement from the agency to support a clear approval pathway and a compelling label. In addition, the patient-centric design of the trials allows all patients to receive treatment with the goal of maintaining or improving vision. The trials leverage an established design to measure non-inferiority against on-label 2 mg of Flibercept. The use of on-label standard of care as the control is a key component of FDA guidance and critical to the non-inferiority design of the trials. Importantly, retinal specialists are familiar with leveraging non-inferiority trial data to inform their prescribing decisions, as the last four wet MD approvals in the United States followed this approach. Furthermore, the inclusion of both treatment-naive and previously treated patients enhances the applicability of our data and can enable a potentially broader label that would help drive increased physician adoption. If approved, our label is expected to have a differentiated six-month dosing interval. This would be a significant improvement compared to current anti-VEGF treatments in the United States, which are dosed on average every two months. Driven by the clear market need for more durable 1MD therapy, DuraView's patient-centric trial design, robust and compelling Phase II clinical data package, and a record of excellent safety across the full clinical development program, we enrolled and randomized over 800 patients in Lugano and Lucia trials. Lucia also marks our global expansion with sites in South America, Europe, Israel, Australia, and India, demonstrating continued momentum and demand across the global WEN-AMD patient community for DuraView. We are proud of the clinical rigor of our Phase III program, Underscored by the fact that both the FDA and the EMA, the two largest regulatory agencies in the world, have signed off on the protocol. And we have exceeded our enrollment timelines with no major changes to our trial design. With a 56-week primary endpoint for both trials, we anticipate Lugano top-line data in mid-2026, with Lucia to closely follow. giving us confidence in our first-to-file and first-to-market position among current investigational sustained release therapies. The consistently positive feedback from physicians and patients continues to strengthen our conviction and to review differentiated profile and eventual commercial success. As part of the efforts to maintain first-mover advantage, We have made significant strides in our commercial readiness while remaining disciplined in our investments. Our state-of-the-art CGMP commercial manufacturing facility in Northbridge, Massachusetts, is designed to meet future commercial demand. In support of a potential NDA filing, the review registration batches are underway. Additionally, we thoughtfully added to our organization, expanding key areas such as late-stage clinical development, regulatory, pharmacovigilance, biometrics, and medical affairs, all while maintaining fiscal discipline. While our top priority is advancing our WebMD program through top-line data and an NDA filing, we are also excited to report our continued progress in DME, the second-largest retinal disease indication. Affecting approximately 25% of diabetic patients, DME is estimated to represent a $3 billion market opportunity by 2030 in the United States. Like wet AMD, the significant burden of regular anti-VEGF injections often results in missed doses and lost vision, suggesting the need for more durable therapies. Following the compelling safety and efficacy results of our Phase II Verona trial in DME earlier this year, we had a positive end of Phase II meeting with the FDA to align on a future pivotal program. We look forward to sharing more details on our pivotal plan in the upcoming months. In summary, with top-line Phase III data for both Lugano and Lucia on track for readout in 2026, and urgent and growing need for safe, effective, and more durable treatment options for wet AMD and DME, iPoint is well-positioned to continue as the leader in sustained release drug delivery for retinal disease as we partner with the retinal community to improve patients' lives while creating long-term value. Our decades of clinical experience, next-generation technology, and blockbuster potential of the Derby franchise highlights our exciting growth story. Before passing it over to George to review our financials, I want to thank the entire iPoint team for their commitment to our goal of improving patients' lives through better vision, as well as the patients and the clinical investigators outside of our organization who are participating on our trials. We deeply appreciate your confidence in us. and we are proud to advance our therapeutics for the benefit of the entire retinal 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 back over to George. George?