8/3/2022

speaker
Operator
Conference Call Operator

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 IvePoint Pharmaceuticals.

speaker
George Elston
Chief Financial Officer

Thank you, and thank you all for joining us on today's conference call to discuss IvePoint Pharmaceuticals' second 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 clinical plans for EYP 1901, and Scott will comment on our 2Q 2022 commercial performance. I will close with commentary on the second quarter 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, as well as commercial and operational developments. A copy of the release can be found on 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 factors section of our most recent annual report on Form 10-K, which is on file with the SEC. and in other filings 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 I-Point Pharmaceuticals.

speaker
Nancy Lurker
President and Chief Executive Officer

Thank you, George. Good morning, everyone, and thank you for joining us. It's been an exciting quarter for Eye Point Pharmaceuticals, and we are very proud of the work we have done to bring ocular therapies to patients with serious eye disorders, and at the same time, create long-term value for our shareholders. It's been a busy quarter, and I'll now review our recent accomplishments. We continue to execute on our pipeline with the first patient dose, and we're very excited about this, last week, in our Phase II W02 clinical trial, evaluating EYP1901 for wet age-related macular degeneration, or wet AMD. As a reminder, EYP1901 is a combination of the small molecule tyrosine kinase inhibitor, Virolinib, and a bioerodible formulation of our proprietary DuraCert technology. We look forward to providing an update on our Phase II PAVIA trial for EYP1901 in a second indication, non-proliferative diabetic retinopathy, also known as NPDR, later this quarter. In July, we presented positive 12-month safety and efficacy data from the Phase 1 Davio clinical trial at the American Society of Retinal Specialists annual meeting. Wet AMD is a serious and potentially devastating eye disorder, accounting for approximately 90% of all AMD-related blindness. Although there are safe and effective FDA approved medications on the market, the treatment paradigm remains a challenging one for patients and physicians. As most patients with wet AMD are treated every month or every other month, requiring frequent trips to the doctor's office and countless injections over their lifetime. EYP 1901 has the potential to provide the substantial benefit of allowing patients a longer duration between doctor's offices and visits of up to six months while maintaining stable visual acuity and macular anatomy. It's important to highlight that we view EYP-1901 not as replacement therapy for existing large molecule anti-VEGF therapy, such as ILEA, Aflibircept, or Lucentis, Renabizumab, but as a treat-to-maintain therapy with a different mechanism of action, a receptor versus ligand binding. that can potentially act as maintenance therapy and use current treatments as supplemental support as needed. Dr. Jay Duker will review in more detail the results of our 12-month Davio2 data later in the call. As I've mentioned in quarters past, I'm very proud of our team's execution of our Phase 1 Davio clinical trial. Just 18 months after we began our trial, we have disclosed positive 12-month data have aligned with the FDA for our phase two trial, and now dosed the first patient in our phase two DAVIO2 clinical trial for wet AMD. Additionally, we were pleased to have hosted our first Investor Day event where we featured commentary from iPoint's management team, as well as guest speakers, Dr. Carl Ruggillo, Professor of Ophthalmology, Thomas Jefferson University, and Dr. Charlie Wyckoff, Director of Research, Retina Consultants of Texas. We discussed the incredible science behind EyePoint's DuraCert drug delivery platform, clinical results, and Phase II plans for EYP1901, and gave a commercial update on UTIC, flucinolone acetonide intravitreal implant, for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye. Turning to our commercial products, we announced the approval of UTIC in China with OccuMention Therapeutics. Utique is the first drug for commercial use in OccuMention's innovative pipeline. We're very pleased to partner with OccuMention to expand Utique's global reach in the emerging Chinese market. And they will now be marking an important milestone in furthering our mission of improving the lives of patients with serious eye disorders around the world. Finally, we saw record net product revenues in Q2 2022, primarily driven by a strong second quarter for Utique. which you'll hear more about from Scott and George later on. On the corporate front, we announced two new board appointments in June and July, and we continue to strategically build out our board and leadership team as our company grows and evolves. First, in June, we elected Dr. Tony Ademus to the board of directors, who is a pioneer in the discovery and early development of anti-VEGF drugs for the treatment of ophthalmic diseases. Tony is best known for his co-discovery of the role of vascular endothelial growth factor, VEGF, in ocular disease, including wet AMD and diabetic retinopathy. Second, in July, we welcomed Karen Siderish, who currently serves as Axogen's president and CEO, to our board of directors. Karen is a pharmaceutical industry veteran who brings more than 35 years of biopharmaceutical and medical device leadership and commercial experience to the role. We also thank the contribution that Ron Eastman, EW Healthcare Partners, made to the board during his four-year tenure. I am indebted to and grateful for the talented iPoint team, which continues to execute quarter over quarter on all clinical, operational, and financial aspects of our business. We are steadfast in our mission to become the leader in sustained ocular delivery in order to deliver improved retinal treatment and bring much-needed therapies to patients around the world. 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?

Disclaimer

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