11/3/2021

speaker
Operator
Conference Call Operator

Good day and thank you for standing by. Welcome to the I-Point third quarter 2021 financial results conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, George Elston, Chief Financial Officer. Please go ahead.

speaker
George Elston
Chief Financial Officer, iPoint Pharmaceuticals

Thank you all for joining us on today's conference call to discuss iPoint Pharmaceutical's third quarter 2021 financial results and recent corporate developments. With me today is 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 pipeline developments for EYP 1901, and Scott will comment on recent progress made on our commercial activities. I will close with commentary on the third quarter 2021 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 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 in 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 the various important factors, including those discussed in the risk factors section of our most recent annual report on Form 10-K, which is filed and on file with the SEC, and in other filings that we may make with the SEC in the future. Any forward-looking statements represents 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.

speaker
Nancy Lurker
President and Chief Executive Officer, iPoint Pharmaceuticals

Thank you, George. Good morning, everyone, and thank you for joining us. We are pleased with our progress during the third quarter, as I point pharmaceuticals continue to make progress across our ocular pipeline to treat serious ocular diseases, as well as maintaining customer demand across our commercial business. We remain laser focused on executing on our overarching mission of bringing innovation to patients with serious ophthalmic diseases. Prior to turning the call over to my colleagues, I'd like to discuss a few of our recent achievements from this past quarter. Importantly, our team continues to advance our Phase 1 DOBO trial for our lead pipeline asset, EYP-1901, a potential twice-yearly treatment for wet age-related macular degeneration, or wet AMD. And we're very much on track to report interim data in the coming weeks. To reiterate our progress throughout 2021, we initiated our Phase 1 trial, dosed the first patient, and completed trial enrollment. Notably, last month, we were pleased to report preliminary three-month safety data for all doses from the Davio trial at the American Society of Retinal Specialists, citing no serious adverse events, ocular or systemic, no adverse events related to significant ocular inflammation or best-corrected visual acuity reduction, nor an elevation of interocular pressure in all 17 patients enrolled. Additionally, no events of endophthalmitis, retinal detachment, or migration into the interior chamber were reported. We're incredibly excited about our progress and we're looking forward to reporting interim safety and efficacy results later this month. Should the results of our Davio interim data prove to be positive, we anticipate starting phase two trials next year. In addition to our focus on EYP 1901, we remain committed to the initiation of a phase three trial for UTIC 5.0 in the fourth quarter of this year. UTIC 5.0 is a potential six-month sustained delivery treatment for uveitis affecting the posterior segment of the eye. UTIC 5.0 will be filed as an SMDA upon completion of this single phase three clinical trial. UTIC 5.0 represents an important part of our expanding pipeline, and we look forward to updating you on our progress in the upcoming quarters. Also included at ASRS was an e-poster presentation highlighting our UTIC CALM real-world registry study, collecting data on patients who have received the UT-CAM plant. This study included patients 18 years of age and older with a diagnosis of noninfectious uveitis affecting the posterior segment. The importance of the UT-CALM real-world registry study cannot be understated. The study is the first of its kind. As I point, we'll be diligently tracking patients suffering from posterior uveitis for up to five years and possibly beyond. The longitudinal data from the CALM study provides scientists and physicians with a unique opportunity to, for the first time, understand the etiology and disease progression of this devastating eye disease. Most importantly, the study should show how UTIC is positively impacting patients' disease compared to standard of care, therefore serving as the foundation for continued innovation in the treatment of posterior segment uveitis. At ASRS, we were very pleased to report that most patients had relatively controlled intraocular inflammation, the hallmark of uveitis, and the registry study continues to progress as we enroll and follow more patients. Turning to our commercial business, we're pleased to report continued growth in underlying customer demand for both products and net product revenues from our shipments to distributors up 49% from Q3 2020. This continued recovery from the pandemic represents an important shift in our patient's comfort level of returning to the doctor's office, and we look forward to bringing our products to more patients in need of transformative ophthalmic therapies. Finally, on Monday, I was very pleased to announce the appointment of Dr. Jay Duker as Chief Operating Officer at iPoint, taking on a full-time expanded role as we continue to develop and advance our innovative pipeline programs. Jay's extensive entrepreneurial experience coupled with his decades of service as chair of the ophthalmology department at Tufts University and his many publications on retinal eye diseases proves him invaluable to iPoint, and we're thrilled to have him on board in this new role. I'd like to thank our fantastic team at iPoint Pharmaceuticals for our company's clinical, operational, and financial success to date. We're very proud of our work thus far across all fronts and look forward to continuing our momentum into the fourth quarter of 2021 and throughout 2022. We're excited about the future of iPoint Pharmaceuticals as we execute on multiple clinical catalysts and strengthen our commercial business while maintaining a strong balance sheet. I'll now turn the call over to Dr. Jay Duker, our Chief Operating Officer. to provide an update on our lead program, EYP 1901, as well as other pipeline initiatives. Jay?

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