EyePoint, Inc.

good morning my name is leeway and i'll be your conference operator today at this time i would like to welcome everyone to the ipoint pharmaceuticals three quarter 2023 financial source and recent corporate development conference call there will be a question and answer session to follow at the completion of the prepared remarks please the advice of this call is being recorded at the company's request I would now like to turn the call over to George Elston, Executive Vice President and Chief Financial Officer of the I-Point Pharmaceuticals. Please go ahead.

Thank you, and thank you all for joining us on today's conference call to discuss I-Point Pharmaceuticals' third quarter 2023 financial results and recent corporate developments. With me today is Dr. Jay Duker, President and Chief Executive Officer. Jay will begin with a review of recent corporate updates and discuss the ongoing Phase II clinical trials for EYP1901. I will close with commentary on the third quarter 2023 financial results, and we will then open the call for your questions. Earlier this morning, we issued a press release detailing our financial results and recent operational developments. A copy of the release can be found in the Investors 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 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 on 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 Dr. Jay Duggar, President and Chief Executive Officer of iPoint Pharmaceuticals.

Thank you, George. Good morning, everyone, and thank you for joining us to discuss iPoint's continued execution toward our milestones as we work to bring first-in-class therapeutics and delivery technologies to patients suffering from serious retinal diseases. In the third quarter, we both advanced and expanded our product pipeline with the announcement of positive mask safety data in our ongoing W02 and PAVIA Phase II clinical trials for our lead product candidate, EYP1901, which is the small-molecule virolinib and our proprietary bio-erodible DuraCert E technology, as well as the unveiling of a new preclinical program, EYP2301. EYP2301 delivers a promising Ti2 activator for zooprotafib, formerly known as AKB9778, formulated in DuraCert E to potentially improve outcomes in wet age-related macular degeneration, or wet AMD, and diabetic eye disease, It's an exciting time at iPoint as our EYP1901 clinical trials approach key data events with top-line Phase II W02 trial results anticipated in early December and PAVIA results in Q2 of next year, and as we plan to initiate a third Phase II trial in diabetic macular edema, or DME, in Q1 of 2024. I'll now review our recent program and corporate updates and give an overview of upcoming catalysts. Turning to our lead program, EYP1901 is being advanced as a potentially paradigm-shifting treatment for patients suffering from VEGF-mediated retinal diseases. EYP1901 is delivered with a single intravitreal injection in the physician's office, similar to the current FDA-approved anti-VEGF biologic treatments. EYP1901 is immediately bioavailable, featuring an initial burst of drug, followed by near-constant zero-order kinetic release for approximately nine months. EYP1901 delivers Verolinib, a selective and patent-protected tyrosine kinase inhibitor formulated in a solid insert using our proprietary sustained-release bioerodible Duracert E technology. Verolinib brings a new mechanistic approach to the treatment of VEGF-mediated retinal diseases by acting as a pan-VEGF receptor blocker. blocking all VEGF isoforms. We expect EYP1901 with its new MOA and sustained drug delivery for up to nine months to meaningfully reduce treatment burden in the majority of wet AMD patients while keeping vision and retinal anatomy stable. Virolanib features reduced off-target binding and at clinically relevant doses does not inhibit TIE2, a critical pathway associated with vascular stability. which may result in an improved efficacy. In a rodent model of retinal detachment, ViroLinib demonstrated neuroprotection, and because it blocks PDGF, may also have antifibrotic benefits. We were pleased to present preclinical and clinical data at multiple medical meetings that underscore the promising profile of EYP1901. One highlight was at last month's Retina Society meeting, were a comparison of the anti-angiogenic profile of three TKIs, virolinib, exitinib, and sutinitinib, validated virolinib as a panVEGF receptor inhibitor that effectively blocks the critical pathways of pathologic angiogenesis. Importantly, the data showed that virolinib is differentiated from the other TKIs tested in retinal disease. Unlike sutinitinib, virolinib does not bind to melanin. And unlike accitinib, virulinib is not expected to have a physiologic impact on normal TIE2 function. As a reminder, the fully enrolled W02 trial is evaluating EYP1901 in 160 subjects with previously treated wet AMD as a maintenance therapy with a goal to maintain stable vision and retinal anatomy for the majority of wet AMD patients for six months or longer following a single injection of EYP1901. This could represent a significant improvement compared to the current anti-VEGF treatments that are dosed on average every two months in the United States under a treatment-extend protocol. This lifetime of frequent treatment represents a tremendous burden for patients, physicians, and the healthcare system in general. EYP1901 has the potential to change this treatment paradigm into a treat-to-maintain model by providing sustained delivery of rolinib for approximately nine months, following induction treatment with a large molecule anti-VEGF like Ann Walker. This may allow patients and practitioners the flexibility to reduce the number of visits without sacrificing visual outcomes. The subjects in the W02 trial were randomized to two treatment arms, approximately 2 milligrams or approximately 3 milligrams of EYP1901 or on label of Flibercept as a control. All subjects of the trial received three loading doses of Aflibricep on day one, month one, and month two, followed by dosing a BYP-1901 or a sham injection 30 minutes after the last loading dose. The FDA approval pathway for this program and the primary endpoint for W02 is non-inferiority in the change of best corrected visual acuity, or BCVA, for each of the 1901 arms versus the Aflibricep control arm. The lower limit of non-inferiority margin is defined as minus 4.5 letter loss by the FDA. For perspective, patients do not generally notice a change in vision until they lose five or more letters, which is the equivalent of one line on an eye chart. I'd like to share our perspective in terms of targeted outcomes for the non-inferiority BCVA, as there are both numerical and statistical considerations for this outcome. First, a very successful outcome in Davio 2 would be to mirror the Phase 1 Davio BCVA results that showed an average of 2.5 letter loss six months after EYP1901 was injected. Recall that Davio was an all-comers, open-label, non-randomized Phase 1 trial. Based on learnings from that Phase 1 trial, we modified inclusion and exclusion criteria for the Davio 2 trial. in an effort to exclude eyes that were not responding to standard of care therapy. We presented masked patient demographic data last quarter that reflects the fact that we enrolled a more controlled patient population in W02 than in the phase one trial. Generally, an outcome of minus three letters or better would be a very strong numerical outcome and possibly statistically non-inferior, even in this relatively small trial. If the EYP1901 arms match or better the minus 1.4 letters difference versus the 2 milligram of Flibercept control, which was what was seen in the 16-week 8 milligram ILEA arm in the PULSAR trial, this would represent an outstanding outcome from a single injection of EYP1901. In addition to stable BCVA, it is critical that the EYP1901 continues to show a favorable safety profile consistent with the interim mass safety update through October 1st, 2023 across all of the EYP1901 clinical trials. As of October 1st, approximately 170 patients have received EYP1901 with a minimum of four months follow-up post-injection from the ongoing Phase II PAVEA and W02 clinical trials and the completed Davio Phase I trial with no reported drug-related ocular SAEs and no reported drug-related systemic SAEs. This continues to give us confidence in the results of this crucial endpoint. Although change in best corrected visual acuity is the primary endpoint, reduction in treatment burden will also be a critical secondary outcome to consider, giving the unmet need in this patient population for more durable therapies. For a clinically meaningful outcome, we believe that one or both EYP1901 arms need to result in a reduction in treatment burden of a minimum of 50% or better for the six months following EYP1901 injection at week eight. In addition, we also believe that 50% or greater of the EYP1901 treated eyes should be supplement-free up to the week 32 visit, along with a relatively stable anatomy as measured by OCT. Based on our market research and KOL interactions, these endpoints will be meaningful to retina specialists who treat wet AMD patients. We plan to host a virtual call with renowned retinal specialists Dr. David Boyer and Dr. David Lally on November 9th at 8 a.m. Eastern Time to discuss their perspectives on the current treatment landscape and the W02 outcome considerations that I just reviewed. We hope that you will all join us for this informative presentation and Q&A. And you can find the link to that call in the investor tab of our website. Looking ahead to the potential phase three pivotal trials for EYP1901 as maintenance therapy in wet AMD, our current plan is to initiate the first trial by the fourth quarter of 2024. This initial trial will be largely in the US and Canada. We hope to initiate a second pivotal trial several months later. The second phase three trial will be largely outside of the US. The Phase II W02 trial of EYP1901 was designed to mirror the anticipated design of the Phase III trials based on our type C meeting with the FDA and other interactions with the agency. The key differences are that the Phase III trials will feature redosing of EYP1901 every six months, and the primary efficacy endpoint will be non-inferior change in visual acuity to approximately one year instead of eight months, as it is in W02. We expect to share more details about this trial in the coming months. Now let me turn to our second indication, NPDR. In June, we reported that enrollment of the Phase II PAVEA clinical trial was complete. PAVEA is a randomized controlled Phase II trial evaluating EYP1901 as a potential nine-month treatment for moderate to severe NPDR. Similar to the DAVIO2 trial, our PAVEA trial saw significant investigator and patient interest during enrollment. The trial enrolled 77 patients, exceeding the 60-patient target. Patients were randomly assigned to one of two doses of EYP-1901, approximately two milligrams or approximately three milligrams, or to the control group that received a sham injection. As in the wet AMD trials, EYP-1901 is delivered with a single intravitreal injection in the physician's office. As a reminder, NPDR is a very common retinal disease that affects almost one-third of diabetic adults over the age of 40. and it's projected to impact over 14 million Americans by 2050. In NPDR, blood vessels are weakened, potentially leading to swelling of the macula, which is called diabetic macular edema, or DME, and may eventually result in abnormal blood vessel growth, which is called proliferative diabetic retinopathy, or PDR. Both DME and PDR can ultimately result in severe visual loss. It is important to note that there remains a great unmet need for a safe, efficacious, and convenient treatment for NPDR that proactively reduces the risk of progressing to a site-threatening complication over the long term. Approximately 90% of patients with NPDR currently receive no course of therapy, apart from observation by their eye doctor, until their disease progresses to DME and or PDR. EYP1901 in our Phase II PAVEA trial could potentially reduce the risk of progressing to these complications with a less intrusive treatment protocol. Recently, we reported an interim analysis of mass safety data from the Phase II PAVEA clinical trial in NPDR, which showed that as of October 1, 2023, EYP1901 was well-tolerated with no reported drug-related ocular or drug-related systemic SAEs. demonstrating EYP1901's excellent safety profile in NPDR for the first time. Top-line data from the PAVIA trial remains on track for the second quarter of 2024. As mentioned earlier, we plan to initiate a Phase II trial evaluating EYP1901 and DME in the first quarter of 2024, which we are calling the Verona trial. We will share details of that trial at a future date. goal of the Verona trial is to gain experience with EYP1901 in this potentially large indication. In September, we disclosed a new preclinical program called EYP2301. EYP2301 is tied to agonist razoprotafib, formerly known as AKB9778, which we have formulated to work in DuraCert E. This has the potential to provide intravitreal sustained delivery over six months or longer to improve the treatment of wet AMD and diabetic eye disease. Previous preclinical and clinical studies show that raciprotafib delivered subcutaneously demonstrated proof of concept in diabetic eye disease. And we believe that delivering EYP2301 intravitrally has the potential to offer new site-saving treatment for patients with severe retinal disease, either alone or in combination with anti-VEGFs. Finally, we were delighted to announce that I-Point expanded its board of directors with the appointment of Stuart Doody, a seasoned biopharmaceutical financial executive who brings more than 25 years of experience to the role. We also strengthened our executive leadership team with a promotion of our CFO, George Elston, to the additional role of executive vice president. George's wealth of experience, financial acumen, and strategic guidance has been a tremendous asset to our iPoint team. On behalf of the entire leadership team, we welcome Stuart and congratulate George, and we are grateful for their valuable leadership at iPoint as we continue to build value for our shareholders during this active time in the company's growth. I'd like to thank the entire iPoint team for an incredibly productive quarter. And I will now turn the call over to George to review the financials. George?