Eyenovia, Inc.

Greetings. Welcome to Inovia's second quarter 2024 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 would now like to turn the conference over to Eric Ribner, Investor Relations. Thank you. You may begin.

Good afternoon, and welcome to Inovia's second quarter 2024 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, we issued a press release announcing financial results for the three months ended June 30th, 2024. We encourage everyone to read today's press release as well as Inovia's quarterly report on Form 10-Q for the quarter ended June 30, 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 quarterly form 10Q as well as our annual reports on form 10K. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 12th, 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 the 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 to our second quarter 2024 financial results conference call. During the second quarter, we advanced several initiatives that we discussed previously that are designed to strengthen the inherent value of Inovia. These include our novel OptiJet dispensing technology, which we recently bought into three dry-eye collaboration agreements of significant mid-term potential value, two FDA-approved products, Midcombi and Covetazole, and Micropine. Micropine is the only drug-device combination therapy in late Phase III development for use in pediatric progressive myopia and is rapidly approaching a pivotal data readout. Adenovia. Our vision is to enhance yours by making topical ophthalmic therapies easier to use and easier to live with. By addressing a broad range of patient and eye care practitioner needs with novel technologies and products that are designed to be user-friendly, we believe we are building a strong foundation for accelerating value creation in 2025 and beyond. I would like to begin this afternoon with an update on MicroPie. our drug-device combination of low-dose atropine administered with our proprietary OptiJet dispenser. This regimen is being developed as a potential treatment for progressive myopia in children. Recall that micropine is currently being evaluated in the ongoing Late Phase III chaperone study. Pediatric progressive myopia is increasingly recognized as an epidemic in both the United States and China. Pediatric myopia is a condition in which the eye abnormally elongates, putting children at risk of losing functional vision and can potentially result in severe retinal complications. 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. Additionally, the rights to micropine have been licensed to Arctic Vision, our partner in China, who is conducting a clinical trial for submission to the Chinese authority. While glasses and contact lenses are the current standard of care for children diagnosed with myopia, they only slow disease progression but do not cure the disease. Current treatments are often not well tolerated or appropriate for the youngest, most vulnerable patients who frequently struggle with discomfort and sit issues. Atropine has been shown in prior studies such as LAMP and ADAMS, to slow myopia progression by as much as 60%. And our proprietary atropine formulation administered with the OptiJet may offer benefits far beyond what could be obtained with a traditional eye drop. With the OptiJet technology, children in the 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 children can see exactly where they are spraying medication and become familiar and comfortable with the dosing process quickly, which can reduce dosing anxiety and minimizes the myriad of struggles parents face with dosing children with conventional eyedrops. The side effects of atropine dosed with the OptiJet have been notably mild and transient 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, we have been measuring the performance of the OptiJet with embedded firmware that allows 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 the clinic staff during visits for the study. For the commercial product, we anticipate Micropine will be equipped with our OptiCare system, which can notify patients and their parents when to administer their spray dose, as well as communicate important compliance and adherence information to the treating physician. Our engineers are working today on plans to validate the system for FDA approval. We are continuing to advance the phase three chaperone study and are planning for an efficacy analysis in the fourth quarter of this year, once a statistically sufficient number of patients have reached the study efficacy endpoint. If the results are positive, this would significantly de-risk the program and potentially enable an NDA submission as soon as late 2025 or early 2026. Recall that the FDA has agreed that a properly conducted single phase three study could be sufficient for an NDA filing and approval. As we have mentioned before, we believe this program would then present a very attractive opportunity for commercialization either by us or a larger partner. Turning now to dry eye, since our last quarterly update, we have executed three collaboration agreements that leverage our OptiJet dispenser for dry eye. Symptoms of dry eye can significantly interfere with daily life, leaving many patients unsatisfied with currently available therapies. According to a recent survey, while 48% of patients reported carefully following their treatment plans, only 13% experienced lasting relief. Nearly 16 million Americans suffer from dry eye, with treatment expenditures totaling over $3 billion in the U.S. and $5 billion globally. Beginning with Formosa, we recently announced that we signed an agreement to develop a formulation of flobetazole in the OptiJet as a potential treatment for acute dry eye. This development program, which would require two 15-day clinical trials, would be free of any upfront fees from Mynovia or development milestones to Formosa until the product is FDA approved. This is an ideal extension of our existing relationship with Formosa and demonstrates how we can extend the use of an eye drop formulation through incorporation of the OptiJet. We also recently signed a collaboration agreement with Senju Pharmaceutical to develop a new adjunctive treatment for chronic dry eye disease. For the terms of that agreement, we will jointly work to develop Senju's epithelial wound healing candidate, SJP35, for use with our OptiJet dispenser. This potential drug-device combination is unique because it would be designed for use alongside other dry eye medications. In other words, it complements existing products rather than competing with them. We are working towards a meeting with the FDA later this year, followed by completion of a Phase IIb study in 2025. If successful, the companies will expand this collaboration to initiate two Phase III studies by 2026. SJP 35 has been shown to be well-tolerated in prior phase 1 and phase 2 studies as a standard eye drop, tested at multiple doses in over 250 subjects. And continuing on with the topic of dry eye, in late February, we entered into a collaboration agreement with SGN Nanopharma, an innovation-led clinical stage nanopharmaceutical company focused on creating impactful, best-in-class nanotherapeutics targeting large unmet medical needs. SGN's proprietary micellular nanoparticle platform allows for the distribution of an active pharmaceutical ingredient into three or more phases, thereby improving its bioavailability, biodistribution, and pharmacokinetics. Per the terms of the agreement, Inovia has been conducting feasibility and process manufacturing testing with SGN Phase III ready ophthalmic cyclosporine formulation, SGN-101. in combination with our Gen 2 OptiJet device as a potential treatment for chronic dry eye. A combination of a faster working cyclosporine than the OptiJet could be a powerful new treatment option for this large and underserved market. With the SGN collaboration, we may have this phase three ready asset next year in chronic dry eye. With these three agreements, we can potentially cover the entire dry eye market, which is a $3 billion annual addressable market in the United States with a multi-million patient population and significant unmet needs. We anticipate achieving this through an acute product for flare-ups with Formosa, an adjunctive chronic medication with Senju, and a chronic medication with SGN. Now I'd like to discuss clobetazole. The FDA approved clobetazole on March 4th, and shortly after the new drug application or NDA for this product, was transferred to us from Formosa. Bobetazole is the first new ophthalmic steroid approved in the U.S. in over 15 years. Bobetazole addresses many unmet needs in ophthalmic steroids with its highly differentiated clinical and pharmacologic profile. It offers twice daily dosing, and from a safety perspective, fewer than 1% of patients experience sudden eye pressure increases, which may be more common with other steroids. Intraocular inflammation and eye pressure spikes are the primary safety concerns for eye surgeons, as they can lead to serious clinical consequences, complications, and non-reimbursable costs for providers. We believe that Clobetazole has the potential to become the leading option in the post-surgical space. This unique steroid is the first product developed using Promosys' proprietary APNT nanoparticle formulation platform. Patients do not have to shake the product prior to use, and that is just one of the unique elements of our approved label. While that may seem minor, it highlights a key difference between Fabetisol and other ophthalmic steroids. Fabetisol's efficacy and its previously discussed safety profile further set it apart. In clinical results, nearly 9 out of 10 patients experienced complete relief from post-surgical pain, and 60% had total resolution of inflammation within 15 days after ocular surgery. with all side effects occurring in less than 2% of cases. Moreover, twice-daily dosing without the need for titration is a clear advantage, especially compared to treatments requiring up to four doses a day. This simplicity is particularly valuable for eye surgery patients who often use multiple medications during recovery. Both eye doctors and patients will appreciate this advancement, which may simplify the treatment regimen. It is estimated that more than 7 million ocular surgeries are performed annually in the U.S. with topical ocular steroids and steroid combinations currently generating 1.3 billion in sales. This represents a significant market opportunity. We believe we can capture a mid-single-digit market share over the next three or four years, as previously mentioned. Our 10 sales representatives, who we began hiring over the last few months and completed their training just two weeks ago, are today pre-qualifying eye surgery offices for their interest in clovetazole. Each representative or key account manager aims to secure 50 offices in preparation for the product launch in the United States. This approach will allow us to hit the ground running and build upon early success. We had previously communicated that we were planning on a commercial launch this summer, which would be supplemented by our co-promotion agreement with Nova Bay Pharmaceuticals. This is still our intent as we await the product arriving here from Formosa. In the meantime, we have expanded our promotional arrangement with NovaBay to include additional products already used by our core customers, enabling our sales force to operate efficiently while they set the stage for what we believe will be a game changer in the ocular steroid treatment. Now I'll provide an update on MidCombi. It is the first and only FDA-approved fixed combination of two well-known pupil dilation drugs for picamide and phenylephrine, and the first approved ophthalmic spray using the OptiJet platform. Now that the hiring and training of our sales force is complete, and we have satisfied licensing requirements in states covering over two-thirds of the U.S. population, we are promoting MidCombi in earnest. As of June 30th, we had trained and converted 63 offices. This was up from approximately eight offices three months earlier. Many of those customers you'll see in our social media channels sharing their positive experiences with the product. We are pleased with this initial trajectory and on track to onboard more than 260 new offices by the end of the third quarter. Additionally, we are partnering with these offices on a waiting room promotional campaign to afford patients without . We're also gathering market research information from these offices to help them bolster their practice satisfaction scores and better care for their patients. Offices and institutions, including the University of California and premier buying groups like VisionSource, have selected Midcombi for several compelling reasons. Unlike traditional eye drops, Midcombi's spray delivers precise amounts of medication, making the dilation process cleaner and more efficient. Clinical studies have reported virtually no stinging, ensuring a comfortable experience for patients. Its hygienic design eliminates protruding tips reducing the risk of cross-contamination between patients. Moreover, Mitcabi works reliably and quickly, setting it apart from other options. At this point, I'd like to turn the call over to our Chief Operating Officer, Bren Kern, for our manufacturing update. Bren?