Eyenovia, Inc.

Greetings. Welcome to Inovia third 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 conference is being recorded. I will now like to turn the conference over to Eric Ribner with Investor Relations. Thank you. You may begin.

Thanks very much, and good afternoon, everyone, and welcome to Inovia's Third Quarter 2021 Earnings Conference Call and Audio Webcast. With me today are Inovia's Chief Executive Officer and Chief Medical Officer, Dr. Sean Ian Shulev, Chief Operating Officer, Michael Rowe, and Chief Financial Officer, John Gandolfo. Yesterday afternoon, Inovia issued a press release announcing financial results for the three- and nine-month period ending September 30th, 2021. We encourage everyone to read yesterday's press release, as well as Inovia's quarterly report on Form 10-Q for the quarter ended September 30th, 2021, which was filed with the SEC. The company's press release and quarterly 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 there for future reference. Please note that on today's call, we will be discussing investigational products which have yet to receive FDA approval. Please note that certain information discussed on the call today is covered under the safe harbor provision 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 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 they go in 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 and implement manufacturing, commercialization, and marketing capabilities and strategies for our product candidates, risks on our end 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 resulting social distancing, timing, progress, and results of such trials, the potential impact of COVID-19 and related economic disruptions on our supply chain, including the availability of sufficient components and materials used in our product candidates, the timing of and our licensees' ability to submit applications for, obtain, and maintain regulatory approvals for our product candidates, Changes in the legal, regulatory, and legislative environment, 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, November 11, 2021. INOVIA undertakes no obligations 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. Sean Iancule.

Thank you, Eric, and welcome everyone to our third quarter 2021 results conference call. This has been a busy time for Inovia with the initiation of our second phase three trial in presbyopia vision two. The recent news on Mitcombi, which is now reclassified as a drug-device combination by the FDA, and the departure of Dr. Fred Eshelman from our board of directors. Microline, as you recall, is our product candidate for presbyopia, a market representing over 18 million people in the United States between the ages of 40 and 55, and who otherwise never wore glasses. Vision 2 is our second phase 3 study for Microline, and we recently announced the first patient enrolled in the study, and we look forward to completing this study early next year. Following Allergan's recent approval of pilocarpine, Inovia is now the only company with a second phase three trial underway. There is growing validation for the pharmacologic treatment of presbyopia with pilocarpine, with now three positive phase three trials between Inovia and AbbVie. Michael will provide additional information in a few minutes about this very important and valuable asset. We're also working on the risk submission for Mitcombi, our unique microdose array print formulation, of two leading midriatic medications or pupil dilation agents. As we recently announced, the Inovia team is working quickly to provide additional information to the FDA for the expedited resubmission of Mitcombi's new drug application as a device-drug combination. We understand the extrinsic circumstances that compelled the FDA to reclassify ophthalmic dispensers, of which our OptiJ is a highly sophisticated groundbreaking technology. Having our product reclassified as a drug-device combination does not change what was seen in our clinical data, and the additional and outstanding regulatory requirements are non-clinician in nature, and we have prepared for this possibility through the years. Now it is a matter of understanding the specifics of the FDA feedback and addressing the items in the CRL. One potential positive is the ability of the OptiJet dispenser in the future to work seamlessly with recent changes to the way that doctors may bill for remote therapeutic monitoring. And the Center for Medicare and Medicaid Services, or CMS, manages the procedure code set that physicians and other healthcare professionals use to reclassify the services for which they bill. These codes are commonly known as CPT code sets, which stands for current procedure terminology. During a recent update, new CPT codes for remote therapeutic monitoring were approved with five new codes that will become effective on January 1st, 2022. Remote therapeutic monitoring has come into greater use with the COVID pandemic and will continue to be an important way for doctors to monitor and treat a greater number of patients. Some of these new codes will cover the remote monitoring of data, including compliance and adherence data for pharmacotherapy, and this may provide a pathway for providers and clinics to get reimbursed for such care. Our OptiJet technology has the potential to become a go-to option for the remote therapeutic monitoring associated with topical ophthalmic drug adherence and compliance. This will not only open a new pathway for smarter, more personalized eye care, but may enable a new reimbursement paradigm that can have real-world benefits for patients with chronic diseases such as glaucoma. We're closely monitoring the CMS and payer adoption of remote therapeutic monitoring and other telehealth initiatives as we work to create and enable the first pipeline of smart eye therapeutics with our OptiJet remote therapeutic monitoring platform. Before turning the call over to Michael on behalf of the entire company, I would like to take a minute to thank our chairman, Dr. Fred Eshelman, who has decided to step down at the end of this year after a decade-long board leadership from the very inception of this technology and the founding of Inovia. Fred has been instrumental to our success and over those many years has made significant contributions to help get us where we are today as a company. The board will be working on a transition plan for the chairman role and potential additions to the board with the necessary skills and backgrounds to make meaningful contributions to the company. I will now turn the call over to Michael Rowe, our Chief Operating Officer, for a review of Michaeline. Michael?