Eyenovia, Inc.

Thank you for standing by. This is the conference operator. Welcome to the INOVIA second quarter 2021 earnings call. As a reminder, all participants are in listen only mode and the conference is being recorded. After the presentation, there will be an opportunity to ask questions. To join the question queue, you may press star then one on your telephone keypad. Should you need assistance during the conference call, you may signal an operator by pressing star and zero. I would like to now turn the conference over to Eric Ribner, Investor Relations. Go ahead, please.

Thank you. Thank you. Good afternoon, everyone, and welcome to Inovia's second quarter 2021 earnings conference call and audio webcast. With me today are Inovia's Chief Operating Officer, Michael Rowe, and Inovia's Chief Financial Officer, John Gandolfo. Dr. Shawn Ianculev, INOVIA's Chief Executive Officer and Chief Medical Officer, has an unavoidable conflict which arose and is not able to join today's call. Earlier this afternoon, INOVIA issued a press release announcing financial results for the three and six months period ended June 30th, 2021. We encourage everyone to read today's press release as well as INOVIA's quarterly report on Form 10-Q for the quarter ending June 30th, 2021. which will be filed with the SEC. The company's press release and quarterly report also will be 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 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 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. Risk 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 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 and 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 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 the Adobe's press release and FCC filings, including its most recent annual report, on Form 10-K and subsequent filing. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 11, 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 laws. With that said, I'd like to turn the call over to Chief Operating Officer Michael Rowe. Michael?

Thank you, Eric, and welcome, everyone, to our second quarter 2021 earnings conference call. The clear highlight since our last quarterly update is the positive data from our Phase 3 Vision 1 study that we announced in May. Vision 1 evaluated the safety and efficacy of our proprietary pylocarpine solution, Microline, versus placebo. with both being administered using our novel OptiJet dispenser. Vision 1 met its primary endpoint with a 7.7-fold higher rate of three or more line responders in mesopic distance-corrected near visual acuity for the microline 2% arm compared to placebo, which was statistically significant and enabled us to select this dose for our second registration trial called Vision 2. In this study, microline had a favorable safety profile. Adverse events were all mild in nature, and there were no serious adverse events. Headache, a frequent issue with pilocarpine delivered as an eyedrop, was seen in fewer than 3% of patients treated with microline. This compares very favorably with the up to 20% that has been observed with other pilocarpine eyedrop formulations. In a post-study survey, 71% of study participants reported strong interest in using Microlign for near-vision improvement should it be approved. These patients said that they would expect to use the product three or four times per week on average. We are very proud of these study results, which is why we are moving rapidly into Vision 2, which I will discuss later. Microlign is not the only drug being developed for presbyopia. We believe, however, that Microlign will offer the best combination of attributes, that will lead it to be a treatment of choice. First, in the Vision 1 study, Microline has been proven to work in a phase three rigorous FDA registration study under highly controlled and validated conditions. Further, Vision 1 produced efficacy outcomes under mesopic or low light conditions. Some other presbyopia treatments in development report photopic treatment outcomes, such as bright ambient light conditions, which can significantly inflate the therapeutic effect due to the added stimulation of bright light and higher contrast, both of which can increase visual acuity measurements. This is an important distinction because in actual practice, presbyopia is more likely to impact functional vision in lower light conditions, such as when trying to read a restaurant menu. Another important distinction of microline versus other therapeutics in development is microline is the only one being developed for on-demand use. In other words, there is no need for chronic dosing. every day or even twice a day for the therapy to work. Finally, Microlime is administered by our OptiJet dispenser, which is far easier to use and more accurate than traditional eyedroppers and has been shown in multiple studies to achieve the same or better efficacy as an eyedrop with better tolerability due to 80% less exposure to drug and preservatives. Needless to say, these results strongly support continued development of Microlimes And to that end, we are planning a second phase three study, Vision 2, that we expect to initiate by the end of the year. Vision 2 will be a registrational double-mass placebo-controlled superiority trial of 2% multi-array pilocarpine versus placebo. We aim to enroll about 100 subjects into the study and anticipate top-line data in mid-2022. With a positive outcome of Vision 2, we plan on moving towards a new drug application or NDA, later in the year. The presbyopia market is significant. In the U.S. alone, there are estimated to be 18 million people between the ages of 40 and 55 who suffer from presbyopia who never had to wear glasses prior to having difficulty with near vision. This translates into a multi-billion dollar potential marketing opportunity. MicroLine is also intended as an on-demand companion product to reading glasses. For instances when readers is inconvenient, or undesirable. When you look at the clinical results, our plans for Vision 2, and the benefits of our OptiJet dispenser, we believe we can capture a significant share of the market should MicroLyme be approved. Turning now to MidCombi, which is our unique fixed combination of two leading midriatic medications, or pupil dilation agents. As we announced last quarter, the FDA has confirmed our QDUFA date for October 28th of this year. Mitkambi is a diagnostic agent with meaningful potential benefits to both the practitioner and the patient. For the practitioner, there's the potential to increase patient throughput without increasing costs. With Mitkambi, doctors and staff can spend less time putting different eye drops into patients, including those that help minimize the sting of the current formulations. On a daily basis, we believe that over an hour of exam room time can be reclaimed just by switching to this faster, more comfortable option. And for patients, since there are no protruding parts with the OptiJet and a recessed nozzle, Midcombi is far less likely to touch the surface of the eye as compared to a conventional eyedropper. This results in a potential decrease in cross-contamination and improved patient safety, something that resonates loudly in the COVID-19 era. Also, as mentioned, the product was reported to be very comfortable to use in our clinical studies. All of these benefits, we hope, will translate to more people being willing to undergo a comprehensive eye exam. Market research suggests that millions of people fail to get a comprehensive eye exam every year due to the discomfort and other side effects of traditional midriatic drops. MidCombie may be able to address these issues, and doctors may be able to further encourage people to take better care of themselves by having a comprehensive eye exam. The market opportunity for MidCombie is substantial. There are an estimated 100 million office-based comprehensive and diabetic eye exams and 4 million ophthalmic surgical dilations performed annually in the United States alone. We estimate this market to be approximately $250 million annually. If approved, we plan to target high-volume practices in the 10 largest U.S. metropolitan areas with just 10 sales professionals to be hired initially. To help maximize this efficiency and create the opportunity for quick payback, our sales force will initially address the top 20% of eye care practices in terms of total patient volume and expand from there. Together with our agreement with Eversana, we believe we are well positioned to initiate a commercial launch soon after approval, pending no disruptions due to COVID-19 on our supply chain. Recall that MidCombie is a cash pay model and purchased directly by the doctor's practice, and this means no interaction with managed care plans, pharmacy benefit managers, and others who may control formulary placement and reimbursement. In addition to the commercial benefits associated with a mid-combi approval, there's also the strategic importance of demonstrating that our OptiJet technology can be reviewed and approved by the drug division of the FDA. This technology underscores all of our projects, and the approval would help de-risk those projects as well. Now I'd like to share some exciting news about our OptiJet digital health system and our ongoing efforts to enable a remote therapeutic monitoring platform for all of our smart microarray print pharmacologic projects. Earlier this year, we shared exciting compliance data from one of our phase three trials showing that subjects were on average 90% compliant using the OptiJet dispenser. This compares favorably to the 50% compliance rate typically reported for eyedropper bottles. Since the technology in the OptiJet has the potential to become the first smart delivery system for pharmacologic eye treatments with fully embedded digital health functions, we will be able to track therapeutic compliance and adherence almost 100%. And our demonstration project from our ongoing phase three trial was well informative to that effect. The OptiJet digital health system could be the first to enable smart pharmacological eye therapy and digital health for chronic eye diseases. This will not only open a new pathway for smarter, more personalized eye care, but may enable a new reimbursable paradigm for remote therapeutic monitoring. The American Medical Association manages the procedure code set that physicians and other health professionals use to identify the services for which they bill. These codes are commonly known as the CPT code set, which stands for Current Procedural Terminology, and our standard billing lexicon for medical services. During a recent meeting of its editorial panel, new CPT codes for remote therapeutic monitoring were approved, with five new codes that will become effective in January 2022. Some will cover acquisition and review of compliance and adherence data for pharmacotherapy, and this may provide a pathway for providers and clinics to get reimbursed for such care. We are closely monitoring the CMS and payer adoptions 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. We look forward to a time in the near future when doctors will be able to deliver better, smarter care that is covered under a potential remote therapeutic monitoring CPT code. I would now like to turn the call over to our Chief Financial Officer, John Gandolfo, to provide a brief update on our licensing agreements as well as a financial update. John?