EyePoint, Inc.

Good day and welcome to the iPoint Pharmaceuticals fourth quarter and full year 2022 financial results conference call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker, Mr. George Elston, Chief Financial Officer. 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 2022 financial results and recent corporate developments. With me today is 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 pipeline developments, and Scott will comment on our commercial activities. I will close with commentary on the fourth quarter and full year 2022 financial results. We will then open up the call for your questions. Earlier this morning, we issued a press release detailing our financial results and recent corporate 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 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 of 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 as 2022 was really an exceptional year for iPoint Pharmaceuticals. We continue to execute on our goal of being the leader in innovative, sustained ocular drug delivery using our best-in-class DuraCert technology to achieve improved outcomes with more convenient dosing regimens. I'll begin by reviewing our lead development program, EYP1901, and why we believe this therapy's six- to nine-month treatment interval, zero-order kinetics, and new ocular mechanism of action could be a game changer in retinal diseases like wet AMD that require lifelong treatment. EYP1901 is a bioerodible durasert insert that delivers virolinib, a selective and patented tyrosine kinase inhibitor delivered through a single intravitreal injection in the physician's office. We have advanced EYP1901 into two phase two clinical trials in wet AMD. and nonproliferative diabetic retinopathy, otherwise known as NPDR, based on the positive Davio Phase I clinical trial results that we reported last year. EYP1901 has emerged as a promising potential therapeutic for serious eye diseases, bringing key attributes to patients, including delivery of the active drug berolinib consistently over six to nine months, with the majority of patients not requiring any supplemental therapy up to six months after a single treatment in wet AMD. A new mechanism of action to treating retinal eye diseases beyond the current anti-VEGF ligand blockers on the market today. The potential for neuroprotective and antifibrotic benefits to the retina. A proven drug delivery technology with a very positive safety profile. And upon completion of our Phase II trials, and importantly, EYP1901 will have the most robust clinical data for any ocular TKI program, with over 180 patients having been dosed by the end of our Phase II programs in both WET-AMD and NPDR. This is in addition to a strong ocular safety and efficacy data set from clinical trials of virolinib, delivered orally in previous trials, treating over 150 patients. EYP1901 delivers the TKI Virolinib, which potentially brings a new mechanism of action to retinal disease beyond what currently exists with the current anti-VEGF large molecule therapies on the market today. When you look at treatment regimens outside ophthalmology, it's often standard practice to address multiple mechanisms of action in parallel in order to improve efficacy. We believe these retinal eye diseases, with serious consequences such as blindness, should be treated using all resources at our disposal as well, through a multi-pronged approach that targets multiple disease drivers. Additionally, EYP1901 sets itself apart by using our proven, best-in-class, bio-erodible DuraCert technology for drug delivery, which delivers the drug at zero-order kinetics, which provides constant, steady dosing over six months or longer. Dr. Jay Duker will review EYP1901's potential unique clinical advantages for patients in more detail later on this call. But of note, we look forward to presenting preclinical neuroprotection data for virolinib from a gold standard mouse model of retinal detachment at the 2023 ARVO annual meeting in April. Beginning with wet AMD, The current standard of care requires monthly or bimonthly eye injections of ligand-blocking anti-VEGF biologics, which can be cumbersome and unpleasant for patients, as it's very difficult for patients to maintain this routine for the rest of their lives. Importantly, we know from robust databases that even one missed or skipped appointment could mean vision loss for the patient. The positive phase 1 Davio clinical trial results support are treat to maintain. therapeutic approach for this disease with the potential to transition a majority of patients to an every-six-month treatment with EYP1901. This can fundamentally change the way physicians treat this disease and manage patients by having drug consistently delivered, providing treatment, which we are confident will enhance patient compliance and improve clinical experience. We are actively enrolling patients in the Phase II W02 clinical trial of EYP1901 as a potential six-month maintenance treatment for wet AMD. This is a massive, multibillion-dollar market opportunity with millions of patients in need of new treatments for this blinding eye disease, and we aim to bring a life-changing treatment to these patients with EYP1901. W02 is a randomized, a Flibercept-controlled, also known as ILEA, trial enrolling approximately 144 previously treated patients. To our knowledge, this is the largest Phase II trial being conducted in wet AMD among TKI treatments. We anticipate announcing top-line six-month results late in the fourth quarter of this year. The Phase II PAVEA clinical trial presents a compelling and proactive potential therapy for the treatment of non-prolificative diabetic retinopathy. The approved large-molecule anti-VEGF biologics to treat NPDR require frequent injections, just like wet AMD, for this disease, where patients may not feel symptoms and, as a result, may forego regular treatment. In fact, nearly 97% of NPDR patients receive no course of treatment, apart from observation by their retinal specialist, until their disease progresses to vision loss. Consequently, there's a great unmet need in NPDR patients for a safe, efficacious, and convenient treatment option that would maintain patient vision proactively through zero-order constant dosing. With EYP1901, we have the opportunity to potentially fulfill this need within every nine months, sustained delivery treatment option for patients that aligns with their office visits and provides patients and physicians with the comfort of having sustained drug delivery during the period between office visits. The PAVEA clinical trial remains on track to complete enrollment. in fourth quarter of this year. Between our W01 trial of 17 patients and our W02 trial of approximately 144 patients, we will have the most robust data set of any other TKI product in development for wet AMD. We are confident that the strength of these data, along with our proven drug delivery system and patented molecule, will give iPoint a significant optionality as we evaluate our pivotal phase three clinical development program path. to market and in discussions with strategic global partnerships. Further, we look forward to enrolling our first patient in a third phase two trial evaluating diabetic macular edema, or DME, in late 2023 or early 2024 timeframe. Importantly, I-POINT continues to remain actively engaged in expanding our sustained ocular delivery pipeline beyond EYP1901. We continue to evaluate molecules for potential use in our DuraCert technology, which can be tailored to each drug and disease indication for future growth. We're very excited because this week we also announced a research collaboration with RallyBio to evaluate their C5 complement inhibitor using our proven DuraCert technology to develop a sustained delivery treatment option for geographic atrophy. We're very excited to update you on this evaluation over the coming quarter, and Dr. Duker will talk further about that as well. Turning now to our commercial results, UTIC continued to demonstrate strong customer demand in the fourth quarter of 2022, which resulted in a very compelling 55% increase in UTIC net product revenue compared to Q4 of 2021. At the upcoming 2023 Arville Annual Meetings, We will present three abstracts discussing our UT Calm study, which is a phase four multi-center registry study, and a collaboration between iPoint and the Cleveland Clinic. Scott Jones, our chief commercial officer, will provide additional detail on this topic later on, but I'd like to recognize our commercial team for delivering on yet again another strong quarter and a strong year of product revenue for UT and for iPoint. Additionally, we're excited to share that in partnership with OccuMention Therapeutics, UTIC launched in China in the fourth quarter of 2022. This commercial launch marks an important milestone in furthering our mission of improving the lives of patients with serious eye disorders around the world. And we're very pleased to partner with OccuMention to expand UTIC's global reach in the emerging Chinese market. Finally, we completed a number of other significant corporate milestones in recent months. This February, we entered into a lease agreement for the construction of a commercial manufacturing facility to support global product supply EYP 1901 in UT. The lease is for a 40,000 square foot standalone facility in Northbridge, Massachusetts that will be built to our specifications. I-Point was awarded 1.9 million of state and local grants for this facility. And of note, lease payments not commencing until completion of construction. which is anticipated in the second half of 2024. This investment reflects the confidence we have in EYP 1901's potential for clinical and commercial success, and this level of control over our supply chain will provide an important point of value differentiation for UT, and we hope eventually EYP 1901 in the years to come. In January of this year, we were also delighted to promote J.S. Duker, MD, to the additional role of president. Dr. Duker has served as a chief operating officer since November of 2021. And in this expanded role, he will continue his duties as chief operating officer and now will also oversee regulatory affairs. Jay has been a tremendous asset to our team since he joined as COO, and we look forward to continuing to benefit from his deep ophthalmic expertise as an expert in retinal surgery and strong leadership in his new role as president. I'll now turn the call over to Dr. Jay Duker, our President and Chief Operating Officer, to provide an update on our lead program, EYP1901, as well as other pipeline initiatives. Jay?