Good morning, everyone, thank you for joining the H.C. Wainwright Third Annual Virtual Ophthalmology Conference. My name is Kyle Meury, and I'm an analyst on the Corporate Access team. H.C. Wainwright is a full-service investment bank dedicated to providing corporate finance, strategic advisory, and related services to public and private companies across multiple sectors and regions. We have a total of 24 publishing senior analysts and over 640 companies covered across all sectors. Please visit hcwco.com for more information. From a logistics standpoint, please make sure to reference your conference portal to access your individual links to your meetings and all presentations. Please join us for panels that will be available live and streaming on Wednesday, August 16th. With that said, have a productive and enjoyable day. I'd like to introduce our presenter, Jay S. Duker, President and CEO of EyePoint Pharmaceuticals. Thank you. Thank you, Kyle. Thank you for inviting me to present. It's really a pleasure to be here. I will remind everyone that I will be making forward-looking statements, and if anybody wants to refer to our website for more details, please feel free. EyePoint is committed to improving the lives of patients with serious retinal diseases, and our pipeline represents potential multi-billion dollar opportunities. Our main pipeline asset is called EYP-1901. It is a bioerodible intravitreal insert with the patented tyrosine kinase inhibitor called vorolanib, and we're investigating it for a variety of VEGF-mediated retinal diseases. We're currently in two Phase II trials, with top-line data for our wet age-related macular degeneration trial anticipated in December of 2023. Our top-line Phase II data for non-proliferative diabetic retinopathy is anticipated in the Q2 of 2024, and we are on track to start a Phase II trial in diabetic macular edema in the Q1 of 2024. Durasert is the name for our proven intravitreal drug delivery technology. Durasert inserts are performed in the office with a routine in-office intravitreal injection. We are able to deliver up to three inserts in a single intravitreal injection in our prepackaged, pre-sterilized injector system. We estimate that Durasert has been safely administered to about 80,000 patients worldwide. From a balance sheet perspective, we've got $142.5 million of cash and investments as of June 30th, 2023. We have no debt, and we have a cash run rate into 2025. This is a schematic of our pipeline. Again, we've got two Phase II trials currently ongoing, a DME to start next year in Phase II, and we have ongoing complement programs in an effort to get sustained-release complement products available to patients. A little bit more about Durasert. In six of the FDA-approved products that have sustained delivery for the back of the eye, Durasert technology is in four of them. Once again, it's done in a simple intraoffice procedure. Durasert features zero-order kinetics, which means after the initial rise in the drug, which typically takes hours to days in the eye, we achieve a steady state for the lifetime of the drug. This steady-state zero-order kinetics allows for what has been referred to as microdosing. Doses that would not seem to work for as well as, as long, given how small they are, do very well in the eye because of the zero-order kinetics. The previous iterations of the Durasert implants were all non-erodible. They're listed on the right in the slide, and you can see we've outlicensed all of those. The current iteration we call Durasert E, and it is bioerodible. Simply, we removed the non-erodible polyamide coating in the other types of Durasert, and the matrix is completely bioerodible. We've designed these inserts so that the matrix lasts longer than the drug, which means we're able to control the drug release at zero-order kinetics for essentially the lifetime of the drug in the insert. Why did we choose vorolanib? Well, Vorolanib is a small molecule tyrosine kinase inhibitor with excellent activity against all the VEGF receptors, which makes it a pan-VEGF blocker. We have composition of matter patents into 2037. Interestingly, vorolanib had been previously tested as an oral agent in wet age-related macular degeneration through Phase II. While it showed pretty compelling efficacy data, unfortunately, there was systemic toxicity as an oral agent, but there was no ocular toxicity observed. Just recently, we presented some in vivo animal studies that suggest that vorolanib may also be neuroprotective. Because we block PDGF, theoretically, we should have an anti-fibrosis effect as well. Again, this is a selective and potent pan-VEGF receptor inhibitor. It most importantly, does not have any activity against the Tie2 receptor. Blocking the Tie2 receptor would result in increased angiopoietin-2 in the eye, which would destabilize the retinal vasculature. This is the data from the animal model of neuroprotective that I alluded to. This showed in the animal model of retinal detachment, treatment with vorolanib resulted in better contrast sensitivity in the animals and less damage to the outer retina from the retinal detachment. We were able to show both structural and functional improvement in animals treated with vorolanib. This is a picture of one of our inserts. They are solid cylinders that are composed, the majority of which is vorolanib, injected into single injection up to three inserts. These inserts are heavier than water. They sink to the bottom of the vitreous cavity and are largely out of the patient's line of sight. These inserts were designed to give sustained zero-order release in a human for approximately nine months, and we've shown positive safety and efficacy data from our Phase I trial, which I will go over shortly. Our Phase I trial was called the DAVIO trial. It was a typical open label, dose escalation, single injection, multicenter, with no control group. We enrolled a total of 17 patients across four dosing cohorts, and we used two payloads in the trial, 440 micrograms and approximately 1 mg. We achieved the mid dose and the high dose by injecting multiple inserts with one injection. Other things to note about this trial is all patients were treated with a standard of care injection on day one, and on week one, they received EYP-1901, and they were followed monthly for one year. We had no inclusion or exclusion criteria based on the activity of the wet macular degeneration at the time of enrollment. Another important thing to note is we only enrolled previously treated patients. We are developing EYP-1901 as a maintenance therapy for wet age-related macular degeneration. We had a supplemental anti-VEGF criteria for this study. If a patient had worsening in their CST, which is a central subfield thickness on OCT of 75 microns, worsening of 10 letters on the eye chart or a hemorrhage, then a supplemental anti-VEGF injection was to be given. This is the top line results from the Phase I, a really favorable safety profile. We had no reported ocular SAEs, no reported drug-related systemic SAEs. The ocular SAEs, AEs rather, that were reported, were generally mild and expected, mostly due to the injection itself, things like ocular irritation, subconjunctival hemorrhage. The only two grade 3 AEs were progression of disease. From an efficacy perspective, given that this is maintenance therapy for a previously treated group, remember, almost all the visual acuity improvements in wet macular degeneration occur in the first three months of treatment, and almost all the OCT improvements occur in the first two months of treatment. For maintenance therapy, stability of vision and stability of OCT are the goals, and we achieve that. Over half the patients were supplement-free up to the six-month visit, and we showed a significant and clinically meaningful reduction in treatment burden of 75% at six months. This is the data on CST and best-corrected visual acuity, and again, notice that at six months, the group as a whole lost about 2.5 letters. At one year, it was 4.1 letters. Remember, there was no re-injection in this study, and the inserts were largely depleted of drug after nine months. CSTs were generally stable. There was some sawtooth pattern that you can see in the graph on the right. That was due to eyes that did require supplementation. This is a swim lane chart to demonstrate that at six months, there was a 75% reduction in treatment burden. Here is the same swim lane. This is a 12-month showing a significant reduction of 73%. Notice that we had several patients, about a third of them, went the entire year of the study with no supplementation. Recall that over half made it to six months, up to six months with no supplementation. We had a couple patients who didn't do particularly well. If you look at patient two, patient 13 and 15, they both required supplement at one month. Let me remind you that everybody had received an anti-VEGF injection at day one. These eyes did not necessarily just fail 1901, they actually failed standard of care, and, and many of them, the three of them went on to receive many additional supplements through the study, and in fact, those three patients accounted for over half the supplements. There were learnings from this Phase I that we've applied to the Phase II in an effort to try to eliminate the type of patient that doesn't seem to do well with our therapy. This is the graph over the years showing the supplementation rate up to each visit. Again, over half at six months and over a third at one year. Again, to summarize the Phase I data, we had no serious drug-related events, either ocular or systemic. Durasert, there was no toxicity, it was tolerated very well, and no dose-limiting toxicity. I might add, we have not found a dose-limiting toxicity in animals with either the dose of Durasert or the number of inserts. Safety is paramount in retinal disease, and there are certain safety issues that retina specialists worry about, including things like endophthalmitis, retinal detachment, retinal vasculitis, posterior segment inflammation. We had none of those in the phase 1. We went on to do a subgroup analysis from the Phase I, and we looked at patients who entered the study with no fluid. Anatomically, they were under good control, but they required frequent injections. Those eyes did particularly well. At the six-month visit, the nine eyes that entered with no excess fluid had a drop in vision of less than 0.5 of a letter. At 11 months, they actually had gained 0.7 letters, and at 12 months, it was -2.2 letters. If you combine those two, you get -1.5 letters over the one year loss of vision. Again, this is without any re-injection. The CSTs were generally stable, as you can see from the graph on the right. This is the swim lane chart for those nine eyes that had no fluid at screening, showing a 92% reduction in treatment burden at six months. There you can see 89% reduction in treatment burden at one year, and you see some of these eyes did very well, even with the relatively low doses. This graph shows you the number of patients who were supplement-free up to each visit. In this subgroup, all the patients were supplement-free up to month four. Two-thirds were supplement-free at month six. Over half the eyes went the full year with no supplementation. This subgroup appeared to do particularly well. Let me show you a case. This is from the Phase I DAVIO trial. This eye received the middle dose of 2 mg approximately, and you can see at the top line on the left, you're looking at an OCT that shows no fluid. The CST was 205 microns. You follow the patient along at, remember, they all got a standard of care injection at day one. They got EYP-1901 at week one. If you look carefully at month three on the bottom left there, I think you can see there's some dark areas accumulating in the retina. While the CST hasn't changed, it's pretty clear this eye is getting fluid. In fact, at month four, you can see in the yellow square over the overlying the picture, that eye got supplemented at month four. Look what happened after that. Eye remained completely dry with essentially stable vision and no further treatment. Now, if you look at the bottom, you can see leading up to the study, this was an eye that was getting treated every four-six weeks. While they did need a supplement, they only needed one over a year. We significantly reduced this treatment burden for this patient. Again, we don't have to work perfectly, meaning no supplements in every patient. Based on the data from the Phase I, we think approximately half of the wet AMD population or more can be safely treated at a six-month interval with our drug alone. Here's another patient, again, dry at screening, at baseline. Received EYP-1901 with standard of care and remained dry really up until month eight. For those of you who aren't used to seeing these OCTs, I can tell you at month eight, there was a little blister of fluid that was just outside of the fovea, subretinal fluid. At month nine, that blister got bigger. Again, the CST is stable, visual acuity looks good, no supplement was performed. You can see the blister of fluid was getting slightly larger until month 12, when the eye got supplemented. This is exactly what we would expect from an insert that would have run out of its drug at about month eight or nine. We're advancing EYP-1901 as a maintenance therapy in wet age-related macular degeneration, and we've coined this term Treat to Maintain. The idea being, newly diagnosed patients could be treated with any anti-VEGF, FDA-approved, and obviously, there's a lot of choices out there for like and blockers, with more coming, and treat with whatever anti-VEGF, you choose or your insurance company allows you to, to get that retina as dry as possible. Now, in the real world, only about 50% of retinas get completely dry with the current therapies. Once you've achieved as good as you can get, if you put a EYP-1901 in, and our data holds through Phase II and Phase III, and we get a label for every six months, and we're safe and effective and tolerable, we believe at least half the patients could be maintained every six months on EYP-1901 alone. Of course, you'll have some of those patients, like the one I showed, who required a supplement early, but then didn't require another one, who's clearly still benefiting from EYP-1901, even though they received one supplement. There will, of course, be some patients who don't necessarily benefit from the drug, like the three patients I showed you in the Phase I. We believe we got 17% of those type of patients in the Phase I because that's the type of trial it is. It's the type of trial where the Phase I doctors don't want to enroll their eyes that are doing well, but rather the eyes that are not doing well. That's really to be expected. Phase II trial, again, we had a Type C meeting with the FDA to go over the pivotal trial designs, and based on feedback from the FDA, we designed the Phase II to look as much like the pivotals as we could. Only again, previously treated wet AMD patients, we required that the central subfield thickness be 350 microns less or less at screening, and that had to be between two weeks and five weeks after their last anti-VEGF. All patients received a loading dose of aflibercept, and the primary outcome is non-inferiority change in visual acuity at weeks 28 and 32 blended. This is an outline of the trial design. Notice at day one, week four, and week eight, all patients receive aflibercept. At week eight, they either receive their 2mg or their 3mg dose of EYP-1901, or they receive a sham after the aflibercept. The eyes are followed monthly and every other month, week 16, week 20, sorry, week 24, week 32, they're either given an aflibercept, if they're randomized to that arm, or they're given a sham aflibercept. There are supplemental criteria that apply here, and interestingly, it's possible that in this trial, you might see supplements given in the aflibercept arm, because the doctor that is recording the need for supplementation is masked to which arm the patient is in. We then recently reported the baseline demographics for the DAVIO 2 trial, this slide compares the baseline demographics between the two trials. Mean ages are approximately the same. As usual, in a wet AMD trial, there's a female preponderance, you can see the best-corrected visual acuities in DAVIO 2 were about a line, five letters better than DAVIO 1, the mean CSTs were considerably less, 265 microns versus 289 microns. That's again, because we had this 350Micron cap for most of the trial on enrollment for CSTs. We also recently reported, and now have updated, the safety findings. Remember, this is masked safety. We have not broken the blind, there are no drug-related ocular SAEs so far in DAVIO 2 as of August 1st. No drug-related systemic SAEs reported either. There have been two ocular SAEs reported. One was a retinal detachment that occurred in one of the eyes. It was a study eye. We don't know what the randomization was, of course, but it occurred one week after the first aflibercept. They had not even received EYP-1901 yet. There was also a retinal hemorrhage that occurred, a significant retinal hemorrhage, but it occurred in a non-study fellow eye. What's next for wet AMD in EYP-1901? This slide outlines our current plan for the Phase III registration trials based on positive Phase II data from DAVIO 2, which again, we should get somewhere around the first week of December. We will have two registration trials, near-simultaneous, one mostly in the U.S., and the second one, both U.S. and ex-U.S.. The trials will have three arms, two doses of EYP-1901, and an on-label EYLEA control. This is similar to the Phase II trial design with the following exceptions: We will plan on doing re-injection of EYP-1901 at six-month intervals. The primary efficacy endpoint will be approximately 12 months, not eight months, and we will monitor the safety data for the second year. We don't know the doses of EYP-1901 yet, because that will be dependent on the Phase II results. Remember, we had this Type C meeting with the FDA last year, they found this overall trial design to be acceptable. We plan on having an end-of-Phase II meeting in the Q1 of 2024 to confirm the plans. Our target right now is first patient in for the first Phase III registration trial in the H2 of 2024. That's, of course, pending positive Phase II data. How about non-proliferative diabetic retinopathy? Non-proliferative diabetic retinopathy is a very common problem. There happens to be 2 FDA-approved products for it, Lucentis and EYLEA, because of the frequency of injection, only about 2%-3% of eligible patients receive the treatment. We believe that a drug that was safe, effective, and tolerable, that could be dosed at a much longer interval, would open up this market tremendously. We're testing that in our Phase II PAVIA trial. This is moderate to severe non-proliferative diabetic retinopathy. The primary endpoint is an improvement, a 2-step improvement in the DRSS, measured at week 36, it's a fairly simple, straightforward trial design. There is, on day one, either the patient receives 2 milligrams of EYP-1901, 3 milligrams of EYP-1901, or a sham injection. As of now, the FDA still allows sham injection as the control in this disease because that is standard of care. Patients are then observed and monitored for potential complications of diabetes or changes in the DRSS, which are measured by color fundus photographs. We should have the top-line data from PAVIA in the Q2 of next year. To reiterate, our balance sheet looks very good. We sold our YUTIQ franchise to our company, Alimera, who we worked with for years. That gave us $75 million upfront and approximately $7.5 million next year. That allowed us to retire all our debt and get our cash runway out into 2025. We've had a strong track record in the last few years of execution. I think this slide illustrates that nicely. Check marks are things that we've accomplished over the last two to three years, and goals for the next six months and highlights to look for, again, DAVIO, phase II top-line data, the DME trial initiation, and PAVIA top-line data, Q2 of next year. Thank you very much for your attention. Thank you, Jay. I want to thank all of our presenters for taking part in what has been a very productive and informative series of presentations. We appreciate the time and the effort that went into preparing them, and we're very grateful for your flexibility and presence at our conference this year. Thank you again from the H.C. Wainwright team.