Eyenovia, Inc.

Good day and welcome to the INOVIA third quarter 2022 earnings call. Today's conference is being recorded. At this time, I'd like to turn the conference over to Eric Rimner, LifeSci Advisors. Please go ahead.

Thanks, everyone, and good afternoon. Welcome to INOVIA's third quarter 2022 earnings conference call and audio webcast. With me today are INOVIA's Chief Executive Officer, Michael Rowe, and Chief Financial Officer John Gandolfo. This afternoon, INOVIA issued a press release announcing financial results for the three months ended September 30th, 2022. We encourage everyone to read today's press release as well as INOVIA's annual report on Form 10-K. The year ended December 31st, 2021, which was filed with the SEC on March 30th, 2022, and our most recently filed 10-Q. The company's press release and annual report are also available on Inovia's website at www.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 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 applied 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, which are described in more detail in our annual report on Form 10-K and our most recently filed 10-Q. Conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, November 10, 2022. 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 that said, I'd like to turn the call over to Michael Rowe, Inovia's Chief Executive Officer. Michael?

Thank you, Eric, and welcome, everyone, to our third quarter 2022 financial results conference call. It's been about 100 days since I've taken over the CEO role from Dr. Iancelot, and we have been laser-focused on increasing our company's value by advancing our key programs. I will provide an operational update and then turn the call over to John Gandolfo, our CFO, for a review of the financials. I would like to begin with Midcombi, which is our proprietary combination microdose formulation of tropicamide and phenylephrine for in-office pupil dilation. In October of last year, we received a complete response letter, or CRL, from the FDA indicating that Midcombi had been reclassified as a drug-device combination product, which ultimately necessitated additional testing of the OptiJet dispensing device. The additional tests included a microbial challenge study that demonstrated the ability of the OptiJet to keep microbes from entering the device, a human factor study assessing the ability of users to follow cleaning instructions for the device, an electronic safety study, and a study on age devices to ensure their long-term reliability. All of these tests have now been successfully completed. It is important to note here that these additional tests were non-clinical in nature. no additional clinical data was requested. The original NDA was supported by two successful Phase III clinical trials, MIST-1 and MIST-2. With the additional device testing complete, we recently resubmitted our MDA and our mid-combate NDA. For normal procedures, the FDA has 30 days from that submission to review our NDA for completeness and to notify us of its acceptance. Once our NDA is accepted, we would anticipate a six-month review process from the date of the resubmission, which could result in approval around mid-year 2023, if all goes as anticipated. If approved, MidCombie would represent an important validation of the OptiJet technology, which has been shown in previous studies to deliver a therapeutic dose of medication with significantly less drug and preservative exposure as compared to standard eye drops. This validation is important not only for our other proprietary programs and our existing partnerships with Bausch and Lohmann Arctic Vision, but also for future potential partnerships where the benefits of the OptiJet may be leveraged in other high-value ophthalmic indications. It is also worth noting that the additional device validation testing that we conducted for the MidCombi NDA may be referenceable in filings for our presbyopia and progressive myopia programs. potentially streamlining those regulatory review processes in the future. Midcombi potentially represents our first commercial product, and so we regard the successful resubmission of our NDA as a significant achievement for our company. Let's move on to Microlign, which is our proprietary topical on-demand pilocarpine-based therapeutic candidate that we are developing for the temporary improvement in near vision associated with presbyopia. Presbyopia is the age-related hardening of the eye's lens causing blurred near vision. This is an addressable market representing over 18 million people in the United States alone between the ages of 40 and 55 who otherwise never wore glasses and have the resources for a cash pay product. In terms of dollars, our proprietary market research suggests that this could be a multi-billion dollar annual market in the U.S. alone. Just a few weeks ago, we announced positive results from Vision 2. which is our second phase three study of microline, and a modified per-protocol analysis of evaluable patients, excluding a non-study-related adverse event impacting pupil size or reactivity, otherwise known as new-onset anisocoria. Vision 2 met its primary endpoint with a statistically significant proportion of subjects treated with microline, showing a 15-letter or more improvement in distance-corrected near-visual acuity with less than a five-letter loss in distance acuity versus placebo, in low-light conditions at two hours post-treatment. The study also achieved all secondary endpoints with statistical significance. A particular note is the compelling safety and tolerability profile of the product. Consistent with prior studies, microline was found to be very well tolerated, with fewer than 3% of microline-treated subjects reporting adverse events, all of which were considered mild and transient. This compares very favorably to other pylo-based presbyopia treatments where about 15% of study subjects reported some form of headache or brow ache. Vision 2 follows the successful outcome of the Vision 1 study that we announced in May of last year. The Vision 1 study evaluated the safety and efficacy of our 1% and 2% pylocarpine microarray print formulations versus placebo, all administered via the optogen. With Vision 1 and 2, we now have completed four studies demonstrating the utility of OptiJet's microdose array print technology in improving the therapeutic index of topical ophthalmic drugs. In terms of next steps, we plan to request a meeting with the FDA to hopefully be held in early 2023 to review the totality of data compiled on Microlign to date and to gain alignment on remaining regulatory steps. Following that meeting, we plan to initiate the manufacture of registration batches at our new state-of-the-art facility in Redwood City, California. We believe there is a significant market opportunity for our spray presbyopia treatment, an alternative to reading glasses when wearing glasses is undesirable. And we believe the OptiJet will allow us to capture a significant share of this market irrespective of the number of eye drop products that may be on the market when we hopefully launch. Now, for the benefit of those of you who may be new to our story, OptiGEN is our proprietary dispensing device, which we incorporate across all of our development programs. It offers significant advantages as compared to standard eye drops, which are difficult to use and can overdose the eye by as much as 300%. This overdosing has been shown to cause potentially dangerous ocular and systemic side effects over time. And speaking of ocular side effects, recent studies of a human conjunctival cell line conducted with Tufts University demonstrated that the OptiJet can minimize the impact of preserved medications on the ocular surface. In fact, preserved medication delivered with the OptiJet acted very similar to non-preserved eye drops with respect to cell viability, cytotoxicity, apoptosis, and metabolic activity in the study. The OptiJet is also significantly easier to use than conventional drops. Since it delivers medication horizontally, there is no need to tilt one's head back, and there is no drug overflow. This helps increase compliance, especially among children. And there is the form factor. It is simply a sophisticated looking device. Finally, the OptiJet is equipped with smart technology that can be paired with devices for the purpose of remote therapeutic monitoring. Earlier this year, we served a 100 glaucoma training ophthalmologists and optometrists to gauge their interest in remote therapeutic monitoring of patients of a type that OptiJet's smart technology can provide. Of the providers surveyed, 98% said that the understanding of compliance and adherence behavior with glaucoma medications was important, with 93% saying it was very important. Notably, almost all providers thought that the availability of the new CPT code for remote therapeutic monitoring, or RMT, would lead to better patient outcomes. Delivering the right dose, making administration easier, minimizing side effects, and improving communication between doctor and patient are just some of the reasons that we feel the opportunity is a paradigm shift in topical ophthalmic medication delivery. We look forward to bringing this technology to not just our own development programs, but through partnering to bring these benefits into the program of others. Before turning the call over to John to review the financials, I want to acknowledge the recent retirement of Ken Lee from our board of directors. Ken has been a valued member of both our board of directors and the Inovia family since 2018. and has made many key contributions to our strategy over the years, particularly as it pertains to the resubmission of our MidCombie NDA. We wish him well in his retirement, and we are encouraged that he has agreed to remain available to us for advice and consultation in the future. I would now like to turn the call over to our Chief Financial Officer, John Gandolfo, to provide a financial update. John?