EyePoint, Inc.

Good morning. My name is Desmond, and I'll be your conference operator today. At this time, I would like to welcome everyone to the iPoint Pharmaceutical first quarter 2023 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 this call is being recorded at the company's request. I would now like to turn the call over to George Elston, Chief Financial Officer of iPoint Pharmaceuticals.

Thank you, and thank you all for joining us on today's conference call to discuss iPoint Pharmaceuticals' first quarter 2023 financial results and recent corporate developments. With me today are Nancy Lurker, Chief Executive Officer, Dr. Jay Duker, President and Chief Operating Officer, and Scott Jones, Chief Commercial Officer. Nancy will begin with a review of recent corporate updates. Dr. Duker will then discuss Phase II clinical trials for EYP1901, and Scott will comment on our first quarter 2023 commercial performance. I will close with commentary on the first quarter 2023 financial results. We will then open up the call for your questions. Earlier this morning, we issued a press release detailing our financial results as well as commercial and 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 those 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 Nancy Lurker, Chief Executive Officer of iPoint Pharmaceuticals.

Thank you, George. Good morning, everyone, and thank you for joining us to discuss our continued success as we advance first-in-class therapeutics and delivery technologies to provide a brighter future for those at risk of losing their sight. 2023 is off to a great start as we continue to build on the solid foundation we laid in 2022 and diligently execute on our clinical and corporate strategies. I'm very pleased with the progress we've made. We made great strides with our clinical trials for EYP1901, including the completion of enrollment in the W02 clinical trial for wet AMD, and accelerated enrollment for our PAVEA trial in non-proliferative diabetic retinopathy. We also delivered a very strong first quarter performance for UT, and as such, we continue to stay focused on our goal of becoming the leader in sustained ocular drug delivery. Before turning the call over to my colleagues, I'll provide an overview of the advances we have made with our lead pipeline program, EYP1901, discuss our achievements from quarter one, 2023, and provide a preview of the potentially value-creating milestones we have ahead. EYP1901 is a potentially game-changing treatment for patients suffering from serious eye diseases. For example, when you look at wet age-related macular degeneration, otherwise known as wet AMD, we believe there's a disconnect between the disease course and how we're currently treating it. Wet AMD is a lifelong disease that's being treated with acute care. as it's currently dosed at monthly or bimonthly intervals under a treat and extend model. This poses a tremendous treatment burden for patients who have to come into their retinal surgeon's office for injections in the eye every one to two months for the rest of their lives or risk losing vision or even blindness. We believe EYP-1901 can potentially remedy this disconnect by providing a long-lasting treatment option for this chronic, lifelong disease with dosing at an interval of six months or longer. When used as a baseline therapy for patients following initial treatment with current standard of care, such as a Flibercept or Farisimab, EYP1901 has the potential to bring a new mechanism of action, significantly reduce the treatment burden of this disease, improve compliance, and potentially ultimately result in better patient vision outcomes. Now, turning to nonproliferative diabetic retinopathy, or NPDR, approximately 90% of patients currently receive no course of treatment, apart from observation by their eye doctor, until their disease progresses to vision loss. This passive treatment approach is primarily due to the very burdensome treatment nature of the short-acting drugs that are available. If a patient isn't actively experiencing vision loss, They are much less motivated to visit their retinal specialist for an injection every one to two months. We hear this thing consistently from retinal specialists. What they want is a longer-acting drug that doesn't require this demanding treatment schedule for their MPVR patients. So there remains a great unmet need for a safe, efficacious, and convenient treatment option that proactively maintains a patient's vision over a longer period of time than the currently available therapeutic options. EYP1901, which is dosed every nine months in our current Phase II NPDR PAVEA trial, can potentially safeguard patients' vision for a much longer period of time between treatments. The current approaches used to treat these eye diseases seem archaic when you look at treatment regimens outside of retina, where it's standard practice to address multiple mechanisms of action in a disease progression in parallel in order to improve treatment efficacy. We believe eye diseases, which have serious consequences such as blindness, should be treated using all resources at our disposal through a multi-pronged approach that targets multiple disease drivers. Virolinib, the active drug used in EYP1901, is a TKI and brings a new mechanistic approach as a pan-VEGF receptor blocker for the potential treatment of wet AMD, NPDR, and diabetic macular edema patients. Additionally, one other potential treatment benefit of EYP1901's mechanism of action is the potential for neuroprotection and anti-fibrotic benefits for patients. We presented preclinical data on varulinib from a gold standard mouse model of retinal detachment at ARVO at the end of April that suggests that this differentiated advantage, which could be another benefit, to set EYP1901 apart from today's commercially approved therapies. Our erodible DuraCert technology, which we call DuraCert E, ties these improvements together, delivering the active drug consistently and reliably with steady zero-order kinetic dosing over six to nine months in the eye. The underlying DuraCert technology has been safely used in thousands of eyes across four FDA-approved products, and we are confident in its ocular safety profile, which is always a number one consideration for patients and physicians especially for treatments in the retina. Moving on, I am delighted to report the substantial progress we made in our two key Phase II trials of EYP1901 in WET-AMD and NPDR. First and foremost, we completed enrollment in our Phase II W02 clinical trial, evaluating EYP1901 in WET-AMD. We were incredibly pleased to exceed the original target enrollment of 144 patients enrolling a total of 160 patients due to the high level of physician and patient interest in the trial. We remain on track to report top-line results in the fourth quarter of this year. When combining the Phase 1 DAWIO results with the future Phase 2 DAWIO2 data, EYP1901 is being studied in more eyes than any other TKI product in development for wet AMD. And we believe this is very important, particularly as we look at strategic considerations with potential partners. The body of evidence we have been collecting on EYP 1901 to date, including both non-clinical and clinical data, supports increased confidence in 1901. The proven value of the anti-VEGF pharmacological mechanism, not only in wet AMD, but across a number of VEGF-dependent retinal diseases, supports a strong rationale for efficacy of EYP 1901 in NPDR. As a result, We believe that a smaller phase two trial in MPDR will provide ample evidence of both efficacy and continued safety and will allow an accelerated path to initiate phase three program in this indication. Jay will talk further about our PAVEA trial. Looking ahead, we also plan to initiate a phase two trial evaluating EYP1901 in diabetic macular edema in the first quarter of 2024. Importantly, we are keeping our eye on the future and remain actively engaged in expanding our sustained ocular delivery product pipeline beyond EYP1901. We continue to evaluate molecules for potential use in our DuraCert E technology, which can be tailored to each drug and disease indication. As an example, in February, we announced our exciting research collaboration with RallyBio to evaluate their C5 complement inhibitor using our DuraCert E technology to develop a sustained delivery treatment option for geographic atrophy. We look forward to updating you on this evaluation over the coming quarters. Turning to our UTEEQ franchise, once again, our commercial team delivered a very strong quarter with 7.4 million in UTEEQ net product revenue, which is a 60% increase over the first quarter of 2022. We remain very pleased with the performance of UTEEQ. as it continues as a profitable franchise in 2023. And we expect single-digit millions in positive cash flow from the UT franchise this year. Scott Jones will provide additional color on this topic later on this call. Now, let me turn the call over to Dr. Jay Duker, our President and Chief Operating Officer, who will provide an update on our lead program, EYP 1901, as well as our other initiatives.