Eyenovia, Inc.

Greetings and welcome to the Inovia third quarter 2024 earnings call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. Should anyone 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 Ribner from Investor Relations. Thank you. You may begin.

Good afternoon and welcome to Inovia's third quarter 2024 earnings conference call and audio webcast. With me today are Inovia's Chief Executive Officer, Michael Rowe, Chief Operating Officer, Bren Kern, and newly appointed Chief Financial Officer, Andy Jones. Welcome, everybody. This afternoon, we issued a press release announcing financial results for the three months ended September 30th, 2024. We encourage everyone to read today's press release, as well as Inovia's quarterly report on Form 10-Q for the second quarter, ended September 30th, 2024, which was just filed with the SEC. The company's press release and annual report are also available on our website at www.inovia.com. In addition, this conference call is being webcast on the company's website and will be archived and available for replay for future reference. Please note that on today's call, we will be discussing products, product concepts, and candidates, some of 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 and subsequent quarterly reports on Form 10-Q. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, November 12, 2024. 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, the floor is yours.

Thank you, Eric, and welcome, everyone, to our third quarter 2024 financial results conference call. During the third quarter, we made significant progress towards transforming inovia into a leader in improving outcomes from topical ophthalmic medications built around our OptiJet technology. First and most near term, we are rapidly approaching a potential phase three efficacy data readout for Micropi, our pediatric progressive myopia product, which if approved, provides entry to a multi-billion dollar addressable market opportunity. Second, we are making advances with our next-generation OptiJet technology and are excited about the progress and what this will mean for our profitability profile. Third, we have been commercializing our Midriasis product, MidCombi, the first FDA-approved product based on OptiJet technology, and we also launched our second FDA-approved product, Clobetazole, an advanced ophthalmic steroid with a highly desirable profile. Fourth, we are advancing our OptiJet development pipeline in dry eye, with clobetazole serving as the cornerstone for three compounds in late-stage development and partially funded through our strategic partners. Now let's take a deeper dive into Microbiome, our OptiJet-based low-dose atropine product candidate for pediatric progressive myopia. Pediatric progressive myopia is increasingly recognized as an epidemic in both the United States and globally. In the U.S. alone, of the nearly 20 million children with myopia, approximately 5 million are considered at risk of losing functional vision due to this disease. While glasses and contact lenses are the current standard of care for children diagnosed with progressive myopia, they are not always appropriate for the youngest children who are also at the most risk of myopic progression. Many younger children do not tolerate contact lenses well, have difficulty putting something on their eye, or may cause themselves injury or illness due to poor lens insertion techniques. Atropine has been shown in prior studies, such as LAMP and ADAM, to slow myopia progression, and we believe our proprietary atropine formulation, administered with the OptiJet, may offer benefits beyond what could be obtained with a traditional eye drop. With the OptiJet technology, children in our Phase III chaperone study, as young as six years old, are dosing themselves nightly with minimal parental supervision. They can self-administer the dose because the OptiJet doesn't require any head tilting or manipulation of an eyedropper bottle, making aiming with a built-in mirror and medication administration achievable. The dosing itself feels like a gentle mist, and children have become familiar and comfortable with the dosing process quickly. This has the potential to reduce dosing anxiety and minimizes the myriad of struggles parents face when dosing children with conventional eye drops. The side effects of atropine dosed with the OptiJet have been notably infrequent and mild in the chaperone study. These results are consistent with what we have come to expect with our advanced drug device dosing system. Throughout the trial, our engineers have been keeping track of the performance of the OptiJet with embedded firmware that also helps study doctors to better understand how and when the device has been used. Each time the dosing button is pressed to administer medication, the device records the event and stores the information. This information can be accessed and reviewed by clinic staff during the patient's visit. For the commercial product, we anticipate Micropine will be equipped with our OptiCare system, which can notify patients and their parents and their caregivers when to administer their spray dose, as well as communicate important compliance and adherence information to the treating doctor. Our engineers are working today on plans to validate the system as part of our anticipated future NDA submission. We are continuing to advance the phase three chaperone study and are looking forward to the outcome of an analysis of the three-year efficacy and safety data very soon. If this analysis conducted by an independent data review committee indicates that we have likely achieved our efficacy endpoint, we would perform a complete analysis and discuss with the FDA an accelerated pathway towards an NDA submission as soon as early 2026. We look forward to providing additional updates on this program during our upcoming KOL virtual event on December 11th. Now let's talk about the advances our team has made with our Gen 2 Opti-Jet. We recently completed the first phase of manufacturing registration batches and are now preparing those cartridges for sterilization and subsequent drug stability testing. This is a key step in the FDA review process for this technology. We are leading with Midcombi as this is our most expeditious path to registration. and we believe would provide a foundation for all subsequent products that are developed for use with the OptiJet. As a reminder, the Gen 2 device has many advancements over its first-generation predecessor, including one-button use and compatibility with our digital compliance monitoring program, OptiCare. It was also developed with fewer parts and is more efficient to manufacture. This greater efficiency translates to lower costs, helping us to achieve margins of up to 90% on our planned product line. We view the introduction of the Gen 2 OptiJet as a significant upcoming inflection point for the company. Now let's look more deeply into MidCombi. MidCombi is also very important to Inovia as it has de-risked our OptiJet technology from a regulatory point of view. Prior to the approval of MidCombi, there were no other products in ophthalmology that combined the approval of a drug with a device containing electronics. We worked very closely with the FDA to identify the various activities, studies, and validation processes necessary to get our device approved, allowing the combi to serve as the precedent for any other optogen-based product. Obtaining FDA approval by itself was a terrific milestone for our company, and we are now recognized as a leader of this technology within eye care. We also understand that introducing this technology into the market requires us the paradigm of using eye drops. With this in mind, we placed MidCombi in about 200 offices and worked closely with those doctors and their technicians to learn more about their perceptions of the OptiJet platform. We found that after using MidCombi 50 times, which translates to about a week, both doctors and technicians felt truly comfortable with the change from eye drops. We also found that four out of five eye care professionals felt that MidCombi was a substantial improvement over eye drops, especially when dilating older people, children, and those who needed to return to work more quickly, as their experience with McCombie was that pupil dilation did not last as long as it did with eye drops, which was highly desirable. As a result of these positive findings, our sales force is now focused on three things. Formulary acceptance of key institutions, retention of the existing offices, and converting another 200 offices over the next few months, which they are working on right now. Before turning the call over to Bren, I'd like to cover a recent change to our board of directors. In September, our founder and board member, Sean Ianculev, stepped down from the chairman role for personal reasons. He will remain on the board and also continue to serve as our executive medical consultant. Charles Mather, who has served on our board since 2018, has been appointed our new chairman. Charlie has significant experience and expertise in capital markets, and his guidance has served us well as we work to keep the company sufficiently funded to advance our development initiatives. We are pleased that we will continue to have both Charlie and Sean as vital resources on our board at this important time for Inovia. At this point, I'll turn the call over to our Chief Operating Officer, Bren Kern. Bren?