EyePoint, Inc.

Good morning, my name is Kevin and I'll be your conference operator today. At this time, I'd like to welcome everyone to the iPoint Pharmaceuticals fourth quarter and full year 2023 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, this call is being recorded at the company's request. I want to like turn the call over to George Elston, Executive Vice President and Chief Financial Officer of iPoint Pharmaceuticals.

Thank you, and thank you all for joining us on today's conference call to discuss iPoint Pharmaceuticals' fourth quarter and full year 2023 financial results and recent corporate developments. With me today is Dr. Jay Duker, President and Chief Executive Officer, and Jay will begin with a review of recent corporate updates and discuss the ongoing clinical trials for EYP1901. I will close with commentary on the fourth quarter and full year 2023 financial results. We will then open the call for your questions. Earlier this morning, we issued a press release detailing our financial results and recent operational developments. A copy of the release can be found in the Investor Relations tab on the corporate 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 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 Pharmaceutical.

Thank you, George. Good morning, everyone, and thank you for joining us. 2023 was truly an exceptional year for iPoint Pharmaceuticals on all fronts. We completed our transformation into a clinical stage biopharmaceutical company with the outlicense of the UT franchise last spring for $82.5 million plus future royalties. We advanced our lead pipeline asset, EYP1901, across three promising indications. wet age-related macular degeneration, or wet AMD, non-proliferative diabetic retinopathy, or NPDR, and diabetic macular edema, or DME. We also significantly strengthened our balance sheet, ending 2023 with $331 million in cash and investments and no debt. This is driven by the UT sale and a $230 million oversubscribed follow-on equity offering. I'd like to review our recent progress for our lead product candidate, EYP1901, a potentially paradigm-altering treatment for patients suffering from VEGF-mediated retinal diseases. In December, we reported positive top-line efficacy and safety data from our Phase II W02 clinical trial in wet AMD, achieving all primary and secondary endpoints. We expect to initiate the first pivotal Phase III wet AMD trial, the Lugano trial, in the second half of this year, with the second pivotal trial, called the Lucia trial, to follow. We also look forward to reporting top-line data for the Phase II PAVEA clinical trial in the second quarter of this year, and top-line data from the Phase II Verona trial in the first quarter of 2025. As a reminder, EYP1901 is an investigational, sustained-release product that consists of a selective and patent-protected tyrosine kinase inhibitor, or TKI, formulated in DuraCert E, the bioerodible version of our proprietary DuraCert technology. Virolinib brings a new mechanistic approach to the treatment of VEGF-mediated retinal diseases by acting as a pan-VEGF receptor blocker, blocking all VEGF isoforms. In addition to the positive safety and efficacy data reported to date, Virolinib has also demonstrated neuroprotection in a validated retinal detachment animal model. Virolinib may also have an antifibrotic effect as it blocks the PDGF receptor. EYP1901 is delivered by an intravitreal injection in the physician's office, similar to the current FDA-approved anti-VEGF biologic treatments. Unlike currently approved biologics and other sustained-release anti-VEGFs in development, EYP1901 is shipped and stored at ambient temperature. Additionally, Virolinib through DuraCert E is immediately bioavailable in the eye, featuring an initial burst of drug followed by our near constant zero-order kinetic release for up to nine months. 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 dosed on average every two months in the United States. And this may allow patients and practitioners the flexibility to reduce the number of visits without sacrificing visual outcomes. Turning to the Phase II W02 non-inferiority clinical trial evaluating EYP1901 in previously treated wet AMD patients as a potential maintenance therapy, All primary and secondary endpoints were achieved in this trial, including a statistically non-inferior change in best corrective visual acuity, or BCVA, versus the aflibricep control for both EYP1901 arms. Non-inferiority change in BCVA is the most commonly used endpoint in wet AMD pivotal trials and subsequent FDA approval. Importantly, EYP1901 continued to demonstrate a favorable safety profile with no EYP1901-related ocular or systemic serious adverse events, or SAEs, reported. We also saw an over 80% reduction in treatment burden measured both prospectively and retrospectively with strong anatomical control in both EYP1901 cohorts. At the angiogenesis meeting in February, investigators reported that a subgroup of W02 patients remained anti-VEGF supplement-free up to six months after delivery of EYP1901. This subgroup demonstrated numerical superiority in change in BCVA, along with strong anatomical control compared to the Aflibricep control group. This result confirms that the positive top-line data from the Phase II W02 trial were driven by EYP1901 and not by supplemental injections. We anticipate initiating the Lugano Phase III trial in wet-empty in the second half of 2024 and the second pivotal trial, Lucia, several months after. The Phase II W02 trial of EYP1901 was designed to mirror the anticipated design of the Phase III trials based on our Type C meeting with the FDA, as well as other interactions. The key differences between W02 and the Phase III trials are that we anticipate that Phase III will feature redosing of EYP1901 every six months, the primary efficacy endpoint will be non-inferior change in BCVA at approximately one year, and the two EYP1901 arms will be one or two inserts versus the two and three inserts used in W02. The decision to use one versus two inserts in the phase three trials is driven by the positive W02 data for both the two milligram and the three milligram doses. The Lugano phase three trial will be conducted largely in the U.S., and the Lucia phase three trial will include U.S. and ex-U.S. sites as we intend to seek EMA approval. We look forward to reviewing our plans at the end of Phase 2 meeting with the FDA in April, and we expect to provide updates after those meeting minutes are received. As I mentioned earlier, we are on track to report top-line data from the Phase 2 PAVEA trial in 2Q of this year. PAVEA is a randomized controlled trial evaluated EYP1901 as a potential nine-month treatment for moderately severe to severe NPDR. The trial enrolled 77 patients who were randomly assigned to one of two doses of EYP1901 or to the control group that received a sham injection. There remains a great unmet need for a safe, efficacious, and convenient treatment for NPDR that proactively reduces the risk of progressing to site-threatening complications over the long term. Approximately 90% of patients with NPDR receive no course of treatment apart from observation by their eye doctors until their disease progresses to DME and or proliferative diabetic retinopathy. This is because the approved treatments are short-acting and therefore require frequent injections. We believe EYP1901 could potentially create a new market for NPDR patients by providing an every-nine-month treatment option that matches a patient's visit cadence. In the PAVEA trial, the primary endpoint is structural. A photograph of the retina is taken on day one of the study and then compared to a photograph taken at month nine. A reading center independently evaluates the photographs to assess the degree of retinopathy on the diabetic retinopathy severity scale, abbreviated the DRSS. The DRSS is a well-validated measure that correlates the functional with the anatomic outcomes. the accepted clinically relevant step change demonstrates a two-step reduction in the scale. In the PAVEA trial, we are looking for at least one-third of the patients to show a greater than or equal to two-step reduction on the DRSS scale at nine months. It's important to note that this is a lower limit and not an expectation. We will also be looking at important secondary endpoints, including reduction in vision-threatening complications, prevention of DME and proliferative diabetic retinopathy, degree of retinal ischemia, and safety. Consistent with our results to date for this program, we expect to see a continued favorable safety profile, a critical factor in any retinal drug. Turning to our third indication, in January, we initiated the Phase II Verona trial, evaluating EYP1901 and a second diabetic eye disease indication, DME, a sight-threatening complication of diabetes that can lead to severe visual loss. Similar to wet AMD, this is a VEGF-mediated disease where there is a significant need for differentiated and longer-acting treatments. Verona is a randomized controlled single-masked Phase II trial of EYP1901 in DME patients previously treated with standard-of-care anti-VEGF therapy. The three-arm trial is expected to enroll approximately 25 patients randomized to one of two doses of EYP1901 or an afibrocept control. The primary efficacy endpoint of the Verona trial is time to first anti-VEGF supplement, up to 24 weeks, based on established criteria. Secondary endpoints include safety, change in BCVA, change in central subfield thickness as measured on OCT, and change in DRSS over time. We remain on track to report top-line data from the Verona trial in the first quarter of 2025. We remain highly encouraged by the growing body of positive clinical data for EYP1901, and we are optimistic that EYP1901 has the potential to change the current treatment paradigm for VEGF-mediated retinal diseases. Turning to our pipeline programs, we announced a new preclinical program, EYP2301, which delivers a promising TIE2 agonist, raciprotafib, formerly known as AKB9778, formulated into RICERT-E. Raciprotafib is an inhibitor of vascular endothelial protein tyrosine phosphatase, or VEPTP. We believe that delivering EYP2301 intravitrally has the potential to offer new site-saving treatment for patients with severe retinal disease, either alone or in combination with anti-VEGFs. We continue to evaluate additional molecules for sustained delivery in DuraCert E, including complement inhibition, and rare diseases, and hope to update you on these programs later this year. Last, I'm delighted to welcome Ramiro Ribeiro, MD, PhD, to iPoint as our new chief medical officer. Dr. Ribeiro is a trained retinal specialist who joins us from Apellis Pharmaceuticals, where he served as vice president, head of clinical development. And we're confident that his proven leadership and strong scientific and clinical background will be a tremendous asset to the iPoint team. I'd like to thank Dr. Dario Pacerino, who served as our chief medical officer for the past seven years. To close, I want to thank the entire I-Point team for an incredible 2023 and a strong start in 2024. The impressive execution and dedication demonstrated by our team to reach these milestones reflects the entire organization's commitment to patients. In addition, I'd like to thank the patients and clinical investigators for their participation in the ongoing trials. Without you all, the progress we've made advancing EYP1901 would not be possible. With our compelling clinical pipeline representing potential multibillion-dollar product opportunities, our best-in-class sustained ocular delivery to research E technology, along with a strong balance sheet, we're well-positioned to grow as a leader in ocular drug delivery and to bring impactful therapies to patients suffering from serious retinal diseases. I will now turn the call over to George to review the financials. George? Thank you, Jay.