Eyenovia, Inc.

Greetings. Welcome to the INOVIA fourth quarter and full year 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 conference is being recorded. I will now turn the conference over to your host, Eric Ribner. You may begin.

Good afternoon and welcome to INOVIA's fourth quarter and full year 2021 earnings conference call and audio webcast. With me today are INOVIA's Chairman, Chief Executive Officer and Chief Medical Officer, Dr. Sean Ianculez, Chief Operating Officer, Michael Rowe, and Chief Financial Officer, John Gandolfo. This afternoon, INOVIA issued a press release announcing the financial results for the three and 12 months ended December 31st, 2021. We encourage everyone to read today's press release as well as Inovia's annual report on Form 10-K for the year ended December 31, 2021, which was filed at the SEC. The company's press release and annual report are also available on Inovia's website at inovia.com. In addition, this conference call is being webcast through the company's website and will be archived for future reference. Please note that on today's call, we will be discussing investigational product candidates 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 Security 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 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 and the Russian invasion of Ukraine, 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 and our licensees' clinical trials, including but not limited to the cost, design, initiation, and enrollment, which could be adversely impacted by COVID-19 and result in social distancing. Timing progress in the results of such trials. The potential impact of COVID-19 and the Russian invasion of grain are related economic disruptions on our supply chain, including the availability of our sufficient components and materials used in our product candidates. The timing of our licenses, ability to submit application for, obtain, and maintain regulatory approvals for our product candidates, changes in the legal, regulatory, and legislative environments and the markets in which we operate, and the impact of these changes on our ability to obtain regulatory approval for our product candidates, 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 the qualified by the cautionary statements contained in Inovia's press release and SEC filings. This conference call contains time-sensitive information and is accurate only as of the date of this live broadcast. I know the undertakes no obligation to provide forward statements to affect events or circumstances after the date of this conference call, except as may be required by applicable law. With all that said, I'd like to turn the call over to Dr. Sean Iancule.

Thank you. Thank you, Eric. And welcome, everyone, to our fourth quarter and full year 2021 financial results conference call. We're excited to recap a very productive quarter and year during which we made significant progress across both of our clinical programs. Regarding MidCombi, we are working to complete the OptiJet device validation work that had been previously requested by the FDA and remain on track to resubmit the NDA in the third quarter of this year. We're assuming a six-month review cycle and are making plans for a targeted launch if approved for the first half of next year. At the same time, we continue to enroll our second Phase III study, Vision 2, for our microline presbyopia program and anticipate data next quarter. If positive, we plan to begin manufacturing our registration lots to support stability and commercial expiration dating as a requirement for an NDA of Microlines. Importantly, the device validation work that we're now completing for MidCombi may be referenced in regulatory filings for our other programs that also use the OptiJet, including Microlines, potentially streamlining the FDA review process for those product candidates after other data requirements are also fulfilled. These are exciting times at Inovia, as we believe we have a clear line of sight to two commercially approved products, both leveraging our proprietary OptiJet dispensing technology. As Michael will discuss in a moment, we also demonstrated empirically for the first time in vitro that delivery of ophthalmic medications with our microarray print delivery system can provide similar benefits to the conjunctiva as our as other non-preserved medications. The importance of this finding cannot be overstated. The OptiJet technology is a key differentiator for us. We leverage it for all of our pipeline programs, as well as Micropin, which, as you may recall, has been outlicensed to Bosch Health and Arctic Vision. At this point, I will turn the call to Michael for an update on our operations. Michael.