EyePoint, Inc.

Good morning. My name is Josh, and I'll be your conference operator today. At this time, I would like to welcome everyone to the iPoint Pharmaceuticals first quarter 2022 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 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, Josh, and thank you all for joining us on today's conference call to discuss iPoint Pharmaceuticals' first quarter 2022 financial results and recent corporate developments. With me today are Nancy Lurker, President and Chief Executive Officer, Dr. Jay Duker, Chief Operating Officer, and Scott Jones, Chief Commercial Officer. Nancy will begin with a review of recent corporate updates. Dr. Duker will then discuss clinical plans for EYP 1901. and Scott will comment on our Q1 2022 commercial performance. I will close with commentary on first quarter financial results, and then we'll 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 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 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, President and Chief Executive Officer of iPoint Pharmaceuticals.

Thank you, George, and apologies for my hoarse voice. I'm still getting over a cold. So good morning, and I do want to thank you for joining us to discuss the very solid progress iPoint made in the first quarter of 2022. Our team has maintained the positive momentum we had in 2021 and now into 2022, and the company continues to be well-positioned to create long-term value for our shareholders, particularly should subsequent clinical trials for EYP1901 report out positively. We are keenly focused to execute on our goal of becoming the leader in ocular joint delivery. In the first quarter, iPoint presented additional validating clinical results of our ongoing phase one trial for our lead pipeline program, EYP1901, while simultaneously advancing two strategic corporate initiatives, refinancing our debt and our just-announced enhanced agreement with Data Pharmaceuticals. We also made important leadership hires that position the company for long-term, successful growth that encompasses our overarching mission of improving the lives of patients with serious eye disorders and bringing our innovative products to patients in the United States and around the world. Prior to turning the call over to my colleagues, I'd like to highlight a few of our achievements in 2022 so far. I'm incredibly pleased with the team's consistent execution of our phase one Davio clinical trial for our lead pipeline asset EYP1901 in wet AMD. As many of you know, wet AMD is a serious and potentially devastating eye disorder accounting for approximately 90% of all AMD-related blindness. But despite these safe and effective FDA-approved medications on the market, treatment adherence remains an ongoing challenge for patients and physicians. Currently, most patients with wet AMD are treated every month or every other month with eye injections. EYP1901, which is a combination of the small molecule TKI-Virolinib, and our proprietary viral rotable drug delivery technology, Duracert, has the potential to transform the currently burdensome treatment paradigm for many wet AMD patients. EYP1901 may be able to provide the substantial benefit of a longer duration between physician office visits and eye injections of up to six months while maintaining stable visual acuity and macular anatomy. We believe based on our interim Phase I Davio clinical trial results, that a majority of patients can potentially be maintained with EYP1901 for up to six months with no supplemental therapy after an initial induction period with traditional anti-VEGF drugs. Under this treat-to-maintain treatment paradigm, EYP1901 provides a number of potential benefits. A new mechanism of action using berolinib, an anti-VEGF tyrosine kinase inhibitor, zero-order kinetics delivery that provides consistent, stable release of oralinib, and the potential ability to sustain a majority of patients up to six months while potentially significantly reducing the treatment burden for patients with wet AMD. As Jay will discuss in more detail later in the call, we continue to be pleased with the ongoing Phase I Davio trial results, which showed positive safety data with no significant inflammation, as well as promising efficacy data at the six and now eight-month follow-up so far. We look forward to announcing our 12-month Phase I W.O. data at ASRS in July of this year. Looking ahead, we expect to initiate our Phase II clinical trial for EYP1901 in WED-AMD in the third quarter of 2022, and we anticipate interim six-month results in the second half of 2023. I'd like to thank the entire I-Point team for their tireless work focused on bringing this innovative technology to as many patients as quickly as possible. And we look forward to sharing additional updates this year on EYP1901's exciting progress. In addition to advancing a Phase II clinical trial of EYP1901 for wet AMD, we are preparing to expand this innovative treatment to additional indications. With a Phase II study of EYP1901 for non-proliferative diabetic retinopathy, or NPDR, beginning in the second half of this year. Along with our focus on development of EYP1901 in the U.S., we continue to consider our options for partnering outside of North America. This quarter, we entered into an agreement to develop and commercialize EYP1901 in China and other selected Asian territories with beta pharmaceuticals. This extension of our current partnerships was already contemplated as part of our 2020 agreement with Beta, where we secured Borolinib right, a critical component of EYP 1901. In addition, we expanded our rights to local delivery of Borolinib for all of ophthalmology, including DME. We look forward to continuing our work with Beta, and we also look to additional partnering opportunities outside of North America at the appropriate time. Regarding our commercial products, we had a strong first quarter, with $9 million in net product revenues, an increase of 32% from the first quarter of last year, along with strong customer demand for both Utique and Dexacute. This strong start to 2022 supports our strategy with the commercial business franchise to achieve break-even status this year. Additionally, we wanted to share an update on our Phase 3 trial of Utique 50, a potential six-month sustained delivery for posterior segment of the eye. The FDA has recently updated the regulatory requirements for ophthalmic drug and device combination products such as UT. These regulatory changes now require I-Point to complete an additional clinical trial for UT50 beyond what was originally communicated for the planned post-approval NDA supplement, resulting in a significant increase in the program's anticipated cost. As a result, we've made the decision to pause enrollment for this study until we can reassess and determine if there's a path forward. I would like to emphasize that this decision is driven by financial considerations only. We still believe in the safety of UTIC 50 and its potential clinical utility, given the proven track record of UTIC 180. Despite this, as an organization, we recognize that we must take a disciplined approach to our pipeline investments and continue to focus our resources on EYP 1901's clinical developments. I'd also like to add that we remain committed to serving the posterior segment uveitis patient community with UTIC 180 and learning more about this serious eye disorder to improve patient outcomes through our ongoing UTIC CALM registry study, which is the first and only registry trial for posterior uveitis, and our UTIC Phase IV synchronicity study, which is a prospective open-label, uncontrolled, two-year follow-up study designed to evaluate the safety and efficacy of the UTIC-180 intervitreal implant for posterior segment uveitis. We plan to update the scientific and patient community on these important studies in the months to come. As you'll hear from George later on, we remain well-capitalized to execute on our pipeline, and we remain focused on iPoint's financial health and cash runway. This included a debt refinancing in Q1 with Silicon Valley Bank, which provided the company with a significant interest rate improvement, resulting in approximately $2.8 million of annual interest savings. Finally, we made important leadership appointments in the first quarter, building out our growing team with two new industry veterans. Earlier this year, we were very pleased to announce the appointment of Michael C. Pine as Chief Corporate Development and Strategy Officer. He brings more than 20 years of business development and strategy experience to iPoint Pharmaceuticals, and we are thrilled to have them on board during this exciting time in the company's evolution. Recently, iPoint also appointed Isabel Lefebvre as Chief Regulatory Officer. Ms. Lefebvre brings over 30 years of global regulatory affairs experience across all phases of drug development, especially in ophthalmic conditions, and we look forward to receiving her guidance on FDA-related matters and global regulatory strategies. I'd like to thank the talented iPoint team, for our company's clinical, operational, and financial success to date. As we advance the future of sustained ocular drug delivery, we look forward to executing on multiple near-term clinical catalysts so that we can deliver improved ocular treatment and ultimately create a better future for patients living with serious eye disorders. I'll now turn the call over to Dr. Jay Duker, our Chief Operating Officer, to provide an update on our lead program, EYP1901, as well as other pipeline initiatives.