Eyenovia, Inc.

Welcome to the I Know Via First Quarter 2021 Earnings Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this call is being recorded. I will now turn the conference over to your host, Eric Rigner. Please go ahead.

Good afternoon, everyone, and welcome to INOVIA's first quarter 2021 earnings conference call and audio webcast. With me today are INOVIA's Chief Executive Officer and Chief Medical Officer, Dr. Sean Ianculev, INOVIA's Chief Financial Officer, John Gandolfo, and INOVIA's Chief Operating Officer, Michael Rowe. Earlier this afternoon, Inovia issued a press release announcing financial results for the three months ended March 31st, 2021. We encourage everyone to read today's press release as well as Inovia's quarterly report on Form 10-Q for the quarter ended March 31st, 2021, which will be filed with the SEC. The company's press release and quarterly report will also be available on Inovia's website. at inovia.com. In addition, this conference call is being webcast to the company's website and will be archived for future reference. Please note that on today's call, we will be discussing investigational products which have yet to receive FDA approval. Please also note that certain information discussed on the call today is covered under the safe harbor provisions of the Private Securities Litigation Reform Act. We caution listeners that during this call, Inovia's management will be making forward-looking statements. Actual results could differ materially from those stated or implied by these forward-looking statements due to the risks and uncertainties associated with the company's business. These forward-looking statements are subject to a number of risks, including risks related to fluctuations in our financial results, volatility and uncertainty in the global economy and financial markets in light of the evolving COVID-19 pandemic, our ability to raise additional money to fund our operations for at least the next 12 months as a going concern. our estimates regarding the potential market opportunity for our product candidates and potential revenue from licensing transactions, reliance on third parties, the ability of us and our partners to timely develop, implement, and maintain manufacturing, commercialization, and marketing capabilities and strategies for our product candidates, risks of our licenses clinical trials, including but not limiting to the cost, design, initiation, and enrollment which could be adversely impacted by COVID-19 and resulting social distancing, timing, progress, and results of such trials, the potential impact of COVID-19 on our supply chain, the timing, and our licensees' ability to submit applications for, obtain, and maintain regulatory approvals for our product candidates, changes in legal, regulatory, and legislative environments, in the markets in which we operate, and the impact of these changes on our ability to obtain regulatory approval for our products, the potential advantages of our product candidates, the rate and degree of market acceptance and clinical utility of our product candidates, our ability to attract and retain key personnel, intellectual property risks, and others detailed in and qualified by the cautionary statements contained in INOVIA's press release and SEC filings, including its most recent annual report on Form 10-K and subsequent filings. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, May 12, 2021. Inovia undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as may be required by applicable securities law. With all that said, I'd like to turn the call over to Dr. Yanchelev. Dr. Yanchelev.

Thank you, Eric, and welcome everyone to our first quarter 2021 earnings conference call. A key highlight since our last quarterly update is that the FDA has confirmed October 28th as the PDUFA date to review our MidCombi NDA. Recall that MidCombi is our unique fixed combination of two leading midriatic medications for pupil dilation. If approved, this would be the first microdose oculotherapeutic applied with a high-precision smart delivery system, the OptiJet. It would also transition us to a commercial-stage company. So we are rapidly approaching a very significant milestone for our company. If approved, we would anticipate launching Mitcombi commercially soon after the FDA approval. In anticipation of potential approval later this In March, we announced an exclusive agreement with Eversana, a leading commercial service provider to the life sciences industry, to manage the physical distribution of Mitcombi and to oversee the order fulfillment process. Michael will elaborate on this shortly. Also, during the first quarter, we completed enrollment in our Vision 1 study of Microline. Our proprietary pilocarpin formulation for the improvement in near vision in patients with presbyopia. Presbyopia is the age-related hardening of the lens of the eye, causing blurred near vision that affects approximately 113 million people in the US alone. The most common remedy is glasses or readers, contact lenses, or surgery. MicroLine is intended to be a companion product to glasses to be used situationally on demand and not necessarily as a full replacement of glasses altogether. We're expecting to see Vision One top line results shortly pending data export and analysis by our data management partners. We anticipate sharing the results in the coming weeks. Those results will help inform how Vision Two will be conducted, helping us to quickly and efficiently complete this program and if approved, unlock a market opportunity that we estimate at nearly eight billion in the US alone. Before turning the call to Michael, I want to comment on the significant addition that we've made to our board of directors last month. We announced that renowned ophthalmologist and scientific leader Dr. Julia Haller has joined our board. Dr. Haller is one of the world's leading retinal surgeons and physician educators. She currently serves as an ophthalmologist-in-chief at Wells Eye Hospital in Philadelphia, where she holds the William Kauffman Endowed Chair. She's also Professor and Chair of the Department of Ophthalmology at Sydney Chemo-Medical College at Thomas Jefferson University and Hospitals. Needless to say, we're very pleased that Dr. Haller has decided to join us, and we believe her insights and guidance will be invaluable as we advance our current programs while in parallel working on our pipeline. At this point, I'll turn the call over to our Chief Operating Officer, Michael Roth, for a more detailed update on our clinical programs. Michael.