Eyenovia, Inc.

Greetings and welcome to the INovia fourth quarter and full year 2022 earnings call. At this time, all participants are in a listen-only mode. A brief 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. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Eric Webner, with investor relations. Thank you, Eric. You may begin.

Thank you, and good afternoon, everyone, and welcome to Inovia's fourth quarter and full year 2022 earnings conference call and audio webcast. With me today are Inovia's Chief Executive Officer, Michael Rowe, Chief Financial Officer, John Gandolfo, and Chief Operating Officer, Bren Kern. This afternoon, INOVIA issued a press release announcing financial results for the three and 12 months ended December 31st, 2022. 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 31st, 2022, which will be filed with the SEC on March 31st, 2023 tomorrow, 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 there 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 the 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, which are described in more detail in our annual report on Form 10-K. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, March 30, 2023. 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 fourth quarter and full year 2022 financial results conference call. I will start with an update on our overall strategy and our current development programs, and then Bren Kern, our Chief Operating Officer, will provide an update on our manufacturing and commercial readiness progress. We will then turn things over to John Gandolfo, our CFO, who will review the financials, as well as our partnerships with Bausch & Lomb and Arctic Vision. We will then open a call for your questions. The fourth quarter caps the successful year for Inovia, as we delivered on all of our key milestones. We resubmitted our Mitkambi New Drug Application, or NDA, and its review by FDA is well underway. In fact, earlier this week, I was at our Reno manufacturing facility while the FDA inspection was taking place. We completed the Vision 2 study for our Microline presbyopia program and recently received very encouraging feedback from the FDA, providing a clear path forward for the program. Our timeline for Microline is as we had planned, and we look forward to providing more granularity in the coming weeks. Regarding our manufacturing, we made substantial progress building out our in-house capabilities, which will be key to our longer-term growth initiatives. Subsequent to the end of the quarter, we also participated in the Consumer Electronics Show in Las Vegas with a very innovative booth highlighting our work in digital health that we believe significantly raised awareness of the optogen. And we announced a co-development agreement with Formosa Pharmaceuticals that will open the door to the development of new therapeutics that leverage our technology. But before we talk about our current programs, I'd like to spend a few moments discussing our longer term strategy. As you probably noticed, we recently have been focusing more on the OptiJet technology and its applicability in areas like digital health, glaucoma, and dry eye. We believe that incorporating the OptiJet technology with late stage drugs and chronic disease areas like glaucoma could result in new therapies that can address many of the major challenges with today's conventional eye drop options. The horizontal delivery of the OptiJet, for example, can make it easier for patients to reliably use their medication. Digital technology could help prescribers and healthcare systems understand how drugs are being used and drive prescribing decisions from a position of knowledge rather than guesswork. And the lower dose volumes and ease of use of the OptiJet can help address tolerability issues that can also impact long-term outcomes of drug therapy. With that in mind, we are focusing our future efforts on partnerships with drug developers such as Formosa to bring together the best available combination of drugs in the OptiJet for the benefit of patients, prescribers, and payers. And speaking of combinations, let's talk now about MidCombi. MidCombi is our proprietary combination microdose formulation of tropicamide and phenylephrine for in-office and presurgical pupil dilation. In December, we announced the FDA had accepted our NDA for MidCombie and assigned a Bidufa action date of May 8, 2023. This was a significant achievement for our company, given the additional testing of the OptiJet device requested by FDA, following its reclassification of MidCombie to a drug-device combination product in October 2021. As I previously mentioned, we are now in the midst of the review process, including an inspection of one of our manufacturing facilities, and we remain in close contact with the agency. I would like to take a moment to thank all of the INOVIA employees, as well as the many technical experts who have helped to get us this far, and we are counting the 39 days until May 8th. It is also worth noting that much of the device validation testing that we conducted for the MidCombie NDA may be referenceable in filings for future programs, potentially streamlining those regulatory review processes. Midconvy, if approved, represents a very meaningful milestone for Inovia for several reasons. One, it is poised to be our first commercial product, ultimately transitioning us to a commercial stage and revenue generating company. But perhaps more importantly, it would represent critical validation of our proprietary OptiJet device technology. potentially changing the paradigm in the way that topical eye drugs are developed and delivered. We are leveraging OptiJet not only with our own development pipeline, but also current and potential future strategic partnerships as well. We currently have partnerships with Arctic Vision for the development of mid-combine, microline, and micropine in greater China and South Korea, and Bausch & Lomb for the development of micropine in the U.S. and Canada. And we are actively working on partnerships for chronic ophthalmic diseases such as glaucoma and dry eye. John will provide an update on our current partnerships during his financial overview. Let's now turn to MicroLine, which is a proprietary topical-on-the-band, tylocarpine-based therapeutic candidate that we are developing for 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-paid product. In terms of dollars, our proprietary market research suggests this could be nearly a billion-dollar annual market in the U.S. alone. As I previously mentioned, following completion of our Vision 2 trial, we recently received encouraging feedback from the FDA, which outlines a very clear path forward for the program toward an NDA. We can't share much more at the moment other than to say that our development timeline is unchanged, and we plan to provide further updates in the coming weeks as warranted. Microline would clearly be differentiated from other presbyopia eyedrop options. First of all, it has demonstrated compelling safety and tolerability. In both Vision 1 and 2, 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 15% or more of study subjects reported some form of headache or browache. Additionally, as a drug-device combination, it may be that Microlign better fits in the business paradigm of optometrists, many of whom also supply glasses and contact lenses for their patients. We are exploring ways in which the device portion of the product could be stocked and stored by eye care practitioners so that they can provide a full service for their patients that can include eyeglasses as well as microline. In summary, we believe the OptiJet represents a key point of differentiation that can set us apart and will resonate with consumers and their doctors as compared to other recently approved topical presbyopia treatments and those to come in the future. Turning to our partnering activities, we were very excited to announce just a few weeks ago a new development collaboration agreement with Taiwan-based Formosa Pharmaceuticals. This agreement seeks to combine our OptiJet with Formosa's unique APNT nanoparticle formulation platform for the potential development of new topical ophthalmic therapeutics that employ the OptiJet device. Formosa's proprietary and innovative APNT platform reduces an active pharmaceutical ingredient's particle size and improves its solubility, thereby allowing more homogenous formulations that may expand the universe of existing and future drugs that could benefit from delivery using the OptiJet. We intend to work together on testing formulations and engaging in discussions with the FDA with the goal of executing a development and commercialization agreement that will see new molecules develop leveraging Formosa's formulation technology in the OptiJet. We believe this agreement with Formosa can serve as a model for future partnerships Add to that end, we are in active discussions with additional parties that may benefit from the OptiJet within their own development programs. Co-development partnerships such as this, in large ophthalmic indications with unmet needs, are a key part of our long-term growth strategy. We have built a significant body of data demonstrating the benefits of OptiJet over conventional eye drops. In January, we added to this by announcing positive results from a research study conducted in collaboration with Dr. Pedram Hamra, Interim Chairman of Ophthalmology at Tufts Medical Center. This study evaluated the gene and protein expression of cytokines and chemokines after treatment with latanoprost and glaucoma medication preserved with BAK administered via OptiJet versus administered via standard eye drops. It is common to use preservatives to support product sterility and prolonged shelf life. Unfortunately, patients treated with BAK preserved glaucoma medications offers suffer inflammatory side effects and develop subsequent ocular surface disease. In this most recent study, human conjunctival cells were used to evaluate three RNA markers that signal inflammatory response in groups treated with lactanoprost plus VAK via the optogen versus standard eye drops. In two out of three cases, cells treated via the optogen had markers decrease. That was statistically similar to preserving a free latatacross delivered via standard eye drops and the control. In these early findings, the OptiJet technology appears better than latatacross plus BAK administered via standard eye drops in reducing inflammatory processes. This is a very important finding, particularly as we look at using the OptiJet in dry eye or glaucoma, where medication is taken over an extended period of time. For the OptiJet, it appears that these harmful and unwanted side effects can be significantly reduced. At this point, I'd like to turn the call over to our Chief Operating Officer, Bren Kern, for a manufacturing update. Bren?