EyePoint, Inc.

Good morning. My name is Jonathan, and I will be your conference operator today. At this time, I would like to welcome everyone to the iPoint Pharmaceuticals' fourth quarter and full year 2021 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. Please go ahead.

Thank you, and thank you all for joining us on today's conference call to discuss iPoint Pharmaceuticals' fourth quarter and full year 2021 financial results and recent corporate developments. With me today is 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 pipeline developments for EYP 1901, and Scott will comment on recent progress made on our commercial activities. I will close with commentary on the fourth quarter and full year 2021 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 development. A copy of the release can be found on 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 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 Nancy Lurker, President and Chief Executive Officer of iPoint Pharmaceuticals.

Thank you, George. Good morning, everyone, and thank you for joining us. as 2021 was truly an exceptional year for iPoint Pharmaceuticals on all fronts. Let me begin by emphasizing the continued positive momentum we have had in the fourth quarter of 2021 and into 2022. We are well-positioned to create long-term value for our shareholders, and we continue to execute on our goal of being the leader in ocular drug delivery. In 2021, iPoint made transformational strides across our business, presenting validating clinical results for our lead pipeline program, EYP1901, significantly strengthening our balance sheet, extending our cash runway, and growing our commercial revenues. Throughout this exciting time, we remain committed to our overarching mission, which is 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 from 2021 and this year so far. The Phase I Davio trial for our lead pipeline asset, EYP1901, is a great example of our team's execution. EYP1901 has the potential to be a new treatment paradigm, potentially providing patients the substantial benefits of longer-term disease maintenance. With EYP1901 administered every six months for a majority of patients, while supplementing as needed with large molecule anti-VEGF treatments for those patients who require more intensive therapy. This is a substantial improvement from today's current treatment paradigm, where most patients are treated every month or every other month. We believe, based on Davio results, that a majority of patients can be maintained up to six months with no supplemental therapy after an initial induction period with traditional anti-VEGF drugs. EYP-1901 is a true six-month sustained release treatment that provides a new mechanism of action with virolinib, a TKI that binds the VEGF receptor, coupled with our proven bio-erodible Duracert technology that delivers virolinib with zero-order kinetics. The combination of a new MOA and zero-order kinetics delivered with Duracert could sustain a majority of patients up to six months and greatly reduced the treatment burden for patients with wet age-related macular degeneration, or wet AMD. In 2021, we dosed the first patient with EYP1901, completed phase one trial enrollment, reported positive 30-day and three-month safety data, and presented positive interim six-month safety and efficacy data, all in under one year's time. Additionally, last month, in February, we followed up with continued positive interim eight-month safety and efficacy data at the angiogenesis, exudation, and degeneration 2022 virtual meeting. We believe EYP1901's potential to transform the treatment paradigm for wet AMD is more important than ever, as we continue to see significant unmet need across the wet AMD treatment landscape, especially in the longer-duration treatment category. Wet AMD is a serious and potentially devastating eye disorder, accounting for approximately 90% of all AMD-related blindness. But despite safe and effective FDA-approved medications on the market, treatment adherence and thus long-term compliance and effects remains an ongoing challenge for patients and physicians. As Jay will discuss in more detail later in the call, We are incredibly pleased with the intra-phase 1WO trial results, which showed positive safety data with no significant inflammation, as well as promising efficacy data at the six- and eight-month follow-up so far. EYP1901's results thus far demonstrate the sustained delivery potential of what our DuraCert technology can accomplish for patients, and we're confident that iPoint is on the right path to becoming the leader in ocular drug delivery. In December 2021, we also concluded a positive and informative Type C meeting with the US FDA, and we expect to initiate our 12-month Phase II study for EYP1901 in wet AMD in the third quarter of 2022, with the first look at interim six-month results in the second half of 2023. The impressive execution and dedication demonstrated by our team to reach this milestone emphasizes the entire organization's commitment to patients, and through the EyePoint team's combined efforts, we aim to bring this innovative technology to many eyes as quickly as possible. In addition to advancing a Phase II trial of EYP1901 for wet AMD, we look forward to expanding this potential paradigm-changing 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. We look forward to providing you all with an update on future indications and clinical activities for EYP1901 in the months to come. Turning to our commercial product pipeline, we are very pleased to report record customer demand for both our commercial products in the fourth quarter of 2021 and a 70% increase in net product revenue compared to 2020. Additionally, we expanded our U.S. commercial alliance with ImpromiseRx which has been a strong partnership since August 2020, as we've been able to focus our efforts internally on our pipeline program while continuing to grow our commercial business despite the ongoing pandemic. We look forward to bringing our approved commercial products to more patients in need of transformative ophthalmic therapies. As you'll hear from George later on, 2021 was also an exceptional year financially, as we successfully completed two upsized follow-on offerings equity offerings during the first and fourth quarters, raising our $230 million, allowing us to end the year with over $210 million of cash and investments on hand. Finally, we continue to grow our organization and leadership team. Earlier this year, we were very pleased to announce the appointment of Michael Pine as Chief Corporate Development and Strategy Officer. In this role, Mr. Pine will be responsible for overseeing all of I-Point's business development and strategy, He brings almost 20 years of business development and strategy experience to iPoint Pharmaceuticals, and we are thrilled to have him on board during this exciting time in the company's evolution. I also want to sincerely thank our fantastic team at iPoint Pharmaceuticals for our company's clinical, operational, and financial success to date. We've made tremendous progress in the last year, and we're so excited and motivated to advance the future of sustained ocular drug delivery. 2022 promises to be another productive and rewarding year for I-Point Pharmaceuticals, and we are committed to continue to execute on multiple clinical catalysts and continue to strengthen our commercial business. 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. Jay?