EyePoint, Inc.

Welcome to the I-Point third quarter 2022 financial results conference call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question at that time, please press star 1-1 on your touchstone telephone. As a reminder, today's conference call is being recorded. I will now turn the conference over to your host, Mr. George Elston, Chief Financial Officer of I-Point Pharmaceuticals. Please go ahead, sir.

Thank you, and thank you all for joining us on today's conference call to discuss iPoint Pharmaceuticals' third 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 Phase II clinical trials for EYP1901 and Scott will comment on our third quarter 2022 commercial performance. I will close with commentary on the third quarter 2022 financial results, and 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 this 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. This includes statements about our future expectations, clinical developments and regulatory matters and timelines, the potential success of our products and product candidates, financial projections, and other 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 factor 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 to discuss the continued progress that iPoint made in the third quarter of 2022. Despite the challenging macroeconomic conditions, we are well-funded to reach our critical readouts, and we remain optimistic about the direction we're headed in as we work to bring innovative ocular therapies to patients with serious eye disorders. Prior to turn the call over to my colleagues, I'd like to highlight a few of our achievements last quarter. We continue to consistently and successfully execute important milestones across our pipeline, with the first patient dose in our Phase II PAVIA clinical trial, evaluating EYP1901 for non-proliferative diabetic retinopathy, or NPDR, in September. Notably, this was our second Phase II clinical trial for EYP1901 initiated in the third quarter. As a reminder, in July, we dosed the first patient in our Phase II Davio II clinical trial for wet age-related macular degeneration, also known as wet AMD. In the 18 months since initiating our Phase I Davio trial, we've completed the trial and reported positive 6- and 12-month data. held a type C meeting with the FDA for our phase two and three clinical trial plans, and initiated our phase two W02 clinical trial for wet AMD and phase two PAVIA trial for NPDR, respectively. I'm very proud of these achievements and will continue to execute consistently and effectively. EYP1901 combines the VEGF receptor binding tyrosine kinase inhibitor virolinib and a bioerodible formulation. of our proprietary DuraCert technology. EYP-1901 has the potential to provide patients a duration between treatments of six months or longer while maintaining stable visual acuity and macular anatomy. It's important to highlight that we view 1901 not as a replacement for current standard of care large molecule anti-VEGF treatments, but as a maintenance therapy with a different mechanism of action. Under this treat to maintain strategy, patients can potentially be extended six months or longer with EYP1901 after becoming stabilized with anti-VEGF standard of care treatment. We are extremely excited to have successfully dosed the first patients in both EYP1901 phase two clinical trials as planned and look forward to providing updates on these trials in the quarters to come. Dr. Jay Duker will review EYP1901's unique value proposition for patients in more detail later on the call. Turning to our commercial business, data from the UTIC-CALM registry study will be presented at a poster presentation at the Retina Society 55th Annual Scientific Meeting, which is taking place right now in Pasadena, California. The CALM study is a phase four multicenter registry study and a joint collaboration between iPoint and the Cleveland Clinic. that will become a valuable resource in furthering the understanding of posterior segment uveitis. Importantly, our commercial team delivered another strong quarter for UTEEQ, with $7.3 million in net product revenue, an increase of 85% from the third quarter of last year, along with continued strong customer demand for UTEEQ. Scott will provide additional detail for this topic later on. Finally, we wanted to share an update on our DexyQ franchise. In October, the company and Impromis Rx mutually terminated an agreement for the commercialization of Dex-Q effective December 31, 2022. This was a result of CMS's proposed hospital outpatient rule published in July, which did not contain an extension of the past year payment period for Dex-Q beyond December 31 of this year. The final 2023 CMS HOPPS rule, which was published yesterday, November 1st, did not modify the proposed rule. This loss of pass-through status at the end of this year will significantly reduce the amount of Medicare reimbursement provided to the companies to execute customers and will result in a significant reduction in the companies to execute product revenues. We are actively looking at all the strategic options for the asset and will provide additional updates in subsequent quarters. I'd like to thank the talented I-Point team for our company's success to date. As we advance the future of sustained ocular drug delivery, we look forward to continued execution on multiple near-term clinical catalysts so that we can become the leader in sustained ocular delivery and ultimately create a better future for patients living with these 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 initiatives. Jay?