EyePoint, Inc.

Good morning. My name is Michelle and I will be your conference operator today. At this time, I would like to welcome everyone to the iPoint fourth quarter and full year 2024 financial results and recent corporate development 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 Financial Officer of iPoint. Please go ahead, sir.

Thank you, and thank you all for joining us on today's conference call to discuss IPoint's fourth quarter and full year 2024 financial results and recent corporate developments. With me today is Dr. Jay Duker, President and Chief Executive Officer. Jay will begin with a review of recent corporate updates and discuss the ongoing clinical trials for DuraView. I will close with commentary on the fourth quarter and full year 2024 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 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 Duker President and Chief Executive Officer of iPoint.

Thanks, George. Good morning, everyone, and thank you for joining us. 2024 was a year of continued execution and exceptional results for iPoint on all fronts, bringing us closer to delivering on our goal of bringing life-changing treatments to patients with severe retinal diseases. On today's call, We will review why we're the leader in ocular sustained drug delivery and how we are uniquely positioned to improve patients' lives with strong data in two potential multi-billion dollar blockbuster indications. We've advanced our best-in-class therapy, DuraView, into phase three clinical trials in wet age-related macular degeneration, or wet AMD. And we've reported positive 24-week Phase II results in diabetic macular edema, or DME, supporting a second Phase III opportunity. DuraView is the only sustained delivery program with robust data for an investigational six-month therapy in both of these indications, highlighting how a differentiated TKI with a new mechanism of action may improve patient outcomes compared to the standard of care. I want to emphasize the safety of our DuraCert technology, beginning with the four products already approved by the FDA and continuing with the strong safety data from the four clinical trials of bioerodible DuraCert E, consisting of over 190 patients treated with DuraView. This superb safety profile coupled with the excellent efficacy data we saw in W02, the largest intravitreal Phase II sustained delivery clinical trial in WET-AMD to date, has driven significant patient and physician interest in our ongoing pivotal trials, with both of our Phase III WET-AMD trials, Lugano and Lucia, surpassing enrollment expectations. I'm pleased to report that we are exceeding historical enrollment rates of comparable wet AMD trials by a substantial margin. The Lugano trial is now well over 50% enrolled, and the Lucia trial is tracking ahead of schedule as well. We continue to expect completion of enrollment in both trials in the second half of 2025, with top line data anticipated in 2026. The tried and true non-inferiority trial design of Lugano and Lucia in wet AMD represents a clear pathway to regulatory approval should the results be positive. In the sustained release space, we anticipate being the first investigational six-month intravitreal wet AMD program to submit a new drug application, or NDA, allowing us to potentially reach patients first. Our patient-centric trial design should enable a broad product label with an optimal dosing interval, thereby providing physicians flexibility and allowing us to capture more of the market share. As part of our preparation for success, our commercial manufacturing facility in Northbridge, Massachusetts is now online with DuraView registration batch manufacturing underway to support an NDA filing. We recently reported positive efficacy, safety, and subgroup data from our Phase II Verona clinical trial for DuraView in DME. Verona met primary and key secondary endpoints, firmly establishing DuraView as the only sustained release TKI program with an active DME program. DME is currently a large market, but has a significant need for sustained delivery options. I will discuss the Verona data in more detail later in this call, but based on the compelling phase two data, we expect to hold an end of phase two meeting with the FDA around pivotal trial design in the second quarter of this year. We remain in a solid financial position. We ended 2024 with a noteworthy balance sheet of $371 million in cash and investments and no debt. This was bolstered by a $161 million oversubscribed follow-on equity offering in the fourth quarter. Turning to our science, DuraView consists of Virolanib, which is a patent-protected, best-in-class tyrosine kinase inhibitor, or TKI, formulated in proprietary bioerodible Duracert E. Duracert has been safely delivered to tens of thousands of eyes across four FDA-approved products. meaning both patients and physicians are exceptionally comfortable with this delivery system and its established safety record. DuraCert E uses a bioerodible matrix that allows for the sustained delivery of drug via zero-order kinetic release for at least six months. Zero-order kinetics means that the drug is delivered at a steady rate so that small payloads can give an extended therapeutic effect with constant tissue exposure. In addition, DuraCert-E allows for immediate bioavailability and, by design, prevents uncontrolled release of free drug floating in the eye. Virolanib is not another anti-VEGF, and DuraView is not just another anti-VEGF program. Virolanib is a potent and selective TKI that brings a new mechanistic approach to the treatment of VEGF-mediated retinal diseases. through intracellular blocking of all VEGF receptors. It therefore blocks all isoforms of VEGF, including VEGF-C and D. Virolanib has demonstrated neuroprotection in a validated retinal detachment animal model and may have an anti-fibrotic benefit as it blocks the PDGF receptor. At tissue exposure achieved with Duravu, Virolanib does not block Ti2. Blockage of the TIE2 receptor is associated with retinal vascular instability. The review is packaged in a pre-filled sterile syringe injector. It is administered by a standard intravitreal injection in the physician's office, similar to the current standard of care anti-VEGF biologic treatments and consistent with current retinal practice dynamics. Unlike currently approved biologics and other sustained release programs in development, however, DuraView can be shipped and stored at ambient temperature. We have strong patent protection for DuraView in both the United States and outside of the U.S. This allows us to protect our innovation and provides us flexibility with our strategic partnerships. In summary, with an excellent safety profile, a distinct mechanism of action, zero-order kinetics that allows for sustained microdose delivery for at least six months, great patent protection, and convenience for physicians, we believe DuraView is well-positioned as an excellent treatment option for patients with VEGF-mediated retinal diseases. Turning to the Phase II Verona clinical trial on DME, we recently announced positive 24-week safety and efficacy data for DuraView, with both DuraView arms meeting the primary endpoint of longer time to first supplement versus control. DuraView 2.7 milligram demonstrated an early, sustained, and clinically meaningful improvement in best corrected visual acuity, or BCVA, with a gain of 7.1 letters compared to baseline, and a central subfield thickness, or CST, improvement of 75.9 microns on OCT measurement. This represents 74% more drying effect versus the Aflib Recept control. Visual and anatomic gains were observed as early as week four and were much more robust than those achieved by the Aflibricep control eyes, demonstrating the immediate bioavailability of DuraView and its differentiated profile as a sustained release TKI. Both DuraView treatment arms showed a favorable safety and tolerability profile with no DuraView-related ocular or systemic serious adverse events reported to date. Yesterday, we presented subgroup analyses from the Phase II Verona clinical trial of the supplement-free patients through week 24. The data demonstrated that for those eyes that went 24 weeks with no supplementation, DuraView 2.7 mg had a significantly better improvement in BCVA and anatomic control compared to the Aflibrocept control group. BCVA improved 10.3 letters compared to baseline versus only three letters improvement for the Aflib-RCEP control group. DuraView 2.7 milligram also demonstrated concomitant structural improvement with CST improvement of 117 microns versus only 31 microns for the Aflib-RCEP control. This result confirms that the positive data from the Phase II Verona trial were driven by DuraView as an active agent, continuously released over six months, and that the unsupplemented eyes had improved visual acuity of about two lines on the eye chart. The highly positive Phase II data supports our plans to engage in discussions with the US and ex-US regulatory agencies to solidify the plans around a pivotal program. As a company, we are highly focused on the successful completion of our Phase III wet AMD program for DuraView. In wet AMD, our goal is to provide a product that maintains stable vision and retinal anatomy for the majority of wet AMD patients within every six-month label. This could represent a significant improvement compared to the current anti-VEGF treatments, that are typically dosed on average every two months in the United States. And it may allow patients and practitioners the flexibility to reduce the number of visits without sacrificing visual outcomes. As previously mentioned, enrollment is ongoing in both of our pivotal phase three wet AMD trials, Lugano and Lucia, with rapid enrollment rates that are exceeding our expectations. Enrollment completion in both trials is expected in the second half of 2025. Both trials have received exceptional investigator and patient enthusiasm to date, driven by an established and familiar trial design. The two essentially identical non-inferiority trials with six-month redosing provide a clear and recognized pathway for global regulatory and commercial success, positioning Duravue to become a potential blockbuster franchise. To close, I'd like to thank the entire I-Point team for an incredible year and a strong start to 2025. The dedication and execution capabilities demonstrated by our team to reach these milestones reflects the entire organization's commitment to improving patients' lives. On that note, I'd also like to thank the patients and the clinical investigators for their participation in our ongoing trials. Without you all, the progress we've made advancing Duravue would not be possible. With our compelling clinical pipeline representing multi-billion dollar product opportunities, our best-in-class sustained ocular delivery, DuraCert E technology, along with a strong balance sheet, we have further established our role as the leader in sustained ocular drug delivery and are well on our way to bringing impactful therapies to patients suffering from serious retinal diseases. I will now turn the call over to George to review the financials. George?