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spk01: Greetings. Welcome to Inovia third quarter 2021 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 will now like to turn the conference over to Eric Ribner with Investor Relations. Thank you. You may begin.
spk07: Thanks very much, and good afternoon, everyone, and welcome to Inovia's Third Quarter 2021 Earnings Conference Call and Audio Webcast. With me today are Inovia's Chief Executive Officer and Chief Medical Officer, Dr. Sean Ian Shulev, Chief Operating Officer, Michael Rowe, and Chief Financial Officer, John Gandolfo. Yesterday afternoon, Inovia issued a press release announcing financial results for the three- and nine-month period ending September 30th, 2021. We encourage everyone to read yesterday's press release, as well as Inovia's quarterly report on Form 10-Q for the quarter ended September 30th, 2021, which was filed with the SEC. The company's press release and quarterly report are also 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 note that certain information discussed on the call today is covered under the safe harbor provision 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 they go in 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 and implement manufacturing, commercialization, and marketing capabilities and strategies for our product candidates, risks on our end 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 of 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 environment, 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 Inovia's press release. and SEC filings, including its most recent annual report on Form 10-K and subsequent filings. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, November 11, 2021. INOVIA undertakes no obligations 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 all that said, I'd like to turn the call over to Dr. Sean Iancule.
spk05: Thank you, Eric, and welcome everyone to our third quarter 2021 results conference call. This has been a busy time for Inovia with the initiation of our second phase three trial in presbyopia vision two. The recent news on Mitcombi, which is now reclassified as a drug-device combination by the FDA, and the departure of Dr. Fred Eshelman from our board of directors. Microline, as you recall, is our product candidate for presbyopia, a market representing over 18 million people in the United States between the ages of 40 and 55, and who otherwise never wore glasses. Vision 2 is our second phase 3 study for Microline, and we recently announced the first patient enrolled in the study, and we look forward to completing this study early next year. Following Allergan's recent approval of pilocarpine, Inovia is now the only company with a second phase three trial underway. There is growing validation for the pharmacologic treatment of presbyopia with pilocarpine, with now three positive phase three trials between Inovia and AbbVie. Michael will provide additional information in a few minutes about this very important and valuable asset. We're also working on the risk submission for Mitcombi, our unique microdose array print formulation, of two leading midriatic medications or pupil dilation agents. As we recently announced, the Inovia team is working quickly to provide additional information to the FDA for the expedited resubmission of Mitcombi's new drug application as a device-drug combination. We understand the extrinsic circumstances that compelled the FDA to reclassify ophthalmic dispensers, of which our OptiJ is a highly sophisticated groundbreaking technology. Having our product reclassified as a drug-device combination does not change what was seen in our clinical data, and the additional and outstanding regulatory requirements are non-clinician in nature, and we have prepared for this possibility through the years. Now it is a matter of understanding the specifics of the FDA feedback and addressing the items in the CRL. One potential positive is the ability of the OptiJet dispenser in the future to work seamlessly with recent changes to the way that doctors may bill for remote therapeutic monitoring. And the Center for Medicare and Medicaid Services, or CMS, manages the procedure code set that physicians and other healthcare professionals use to reclassify the services for which they bill. These codes are commonly known as CPT code sets, which stands for current procedure terminology. During a recent update, new CPT codes for remote therapeutic monitoring were approved with five new codes that will become effective on January 1st, 2022. Remote therapeutic monitoring has come into greater use with the COVID pandemic and will continue to be an important way for doctors to monitor and treat a greater number of patients. Some of these new codes will cover the remote monitoring of data, including compliance and adherence data for pharmacotherapy, and this may provide a pathway for providers and clinics to get reimbursed for such care. Our OptiJet technology has the potential to become a go-to option for the remote therapeutic monitoring associated with topical ophthalmic drug adherence and compliance. This will not only open a new pathway for smarter, more personalized eye care, but may enable a new reimbursement paradigm that can have real-world benefits for patients with chronic diseases such as glaucoma. We're closely monitoring the CMS and payer adoption 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. Before turning the call over to Michael on behalf of the entire company, I would like to take a minute to thank our chairman, Dr. Fred Eshelman, who has decided to step down at the end of this year after a decade-long board leadership from the very inception of this technology and the founding of Inovia. Fred has been instrumental to our success and over those many years has made significant contributions to help get us where we are today as a company. The board will be working on a transition plan for the chairman role and potential additions to the board with the necessary skills and backgrounds to make meaningful contributions to the company. I will now turn the call over to Michael Rowe, our Chief Operating Officer, for a review of Michaeline. Michael?
spk08: Thank you, Sean, and good evening, everybody. I would like to start with a review of our Microline program. Microline is our proprietary microdose array print pilocarpine therapy for the temporary improvement in near vision associated with presbyopia. Allergan recently received FDA approval for the same molecule as an eye drop for the treatment of presbyopia, and we are very happy to see them opening up this market. Inovia's product is different in that Microline is designed to be used on demand. with the benefits of microdosing reflected in the very low rate of brow or headache seen in our Vision 1 trial and a much easier and neater way of instilling the drug through the OptiJet device. As you may recall, we announced positive data from our first Phase 3 presbyopia clinical trial, Vision 1, earlier this year. Data from that study demonstrated positive efficacy and safety with far fewer side effects reported relative to pilocarpine eye drop formulations. Importantly, in a post-study survey, 71% of study participants reported strong interest in using Microlide for near vision improvement when approved. These patients said that they would expect to use the product three or four times per week on average. We recently announced the first patient enrolled in our second phase three clinical trial, Vision 2. Vision 2 is a registrational, double-masked, placebo-controlled superiority trial of 2% multi-array print pilocarpine versus placebo. We aim to enroll about 140 subjects into the study and anticipate top-line data in early 2022. We believe the addressable market for presbyopia to be many times greater than the addressable market for almost any other ophthalmic condition. So we are very excited about the potential of Microlign as a key driver of our long-term growth. In the US alone, there are estimated to be 18 million people between the ages of 40 and 55 who suffer from presbyopia but who never had to wear glasses prior to having difficulty with near vision. This translates into a multi-billion dollar potential market opportunity. MicroLine is also intended as an on-demand companion product to reading glasses. For instances when using readers is inconvenient or undesirable. When you look at the clinical results or plans for Vision 2 and the benefits of our OptiJet dispenser, we believe we can capture a significant share of the market should MicroLine be approved. As Sean mentioned, our team is working on the resubmission of MidCombie to the FDA in response to the complete response letter. The reclassification, which caused the FDA to modify their initial classification of our product from a drug to a drug-device combination, was triggered by a recent court case, Genus Medical Technologies versus FDA. More information about which we have made available on our website. Specifically, the FDA is requesting certain device validation reports that were not required under a drug submission. One example would be validation reports for laboratory studies that demonstrate that the capabilities of the OptiJet device would not degrade over the period of its shelf life. We routinely conducted these types of studies but did not submit a report with the Mitcambi NDA because it was not required under a drug submission. Now we are taking this information along with other work we have done and packaging it for resubmission. We cannot empathize this enough. The CRL raised no issues with our clinical results or the product safety or efficacy, and this CRL has no impact on our other programs. As Sean mentioned, the reclassification of InCombi to a drug-device combination may have broader positive implications for our platform technology, as well as streamline the future review of other late-stage development programs, MicroLine and MicroPine. These programs also leverage our OptiJet microdose dispensing technology. So the information being developed to support the drug-device combination filing is very likely transferable across these programs. This is keenly important as we continue to develop MicroLine for presbyopia, a program with a multibillion-dollar sales potential. In summary, Inovia is moving forward on multiple fronts with late-stage programs that offer great potential benefits for patients, providers, and our shareholders. We are excited about the potential benefits our technology can bring in light of the recent focus on remote therapeutic monitoring. We remain focused on progressing these programs to potential regulatory approval as efficiently as possible and look forward to providing additional updates in the coming weeks and months. I would like to turn the call over now to our Chief Financial Officer, John Gandolfo, to provide a brief update on our licensing agreements, including the status of MicroBind, as well as a financial update. John?
spk06: Thank you, Michael. I will start with a brief update of our licensing agreements with Bausch Health for micropine in the US and Canada and Arctic Vision for all three of our drugs in China and South Korea. Micropine is a proprietary atropine formulation for the reduction of pediatric myopia progression. It has been shown in clinical studies to slow myopia progression by 60% or more. There are currently no FDA-approved drug therapies for this indication, And if left untreated, this can result in retinal detachment, myopic retinopathy, and vision loss. Bifocal or multifocal glasses or contact lenses are typically prescribed to myopia children. Recall that as part of the agreement with Bashell, they agreed to assume oversight and costs related to the ongoing phase three chaperone clinical trial. This is a 48-month US-based multi-center randomized double mass trial that is enrolling more than 400 children between 3 and 12 years of age. The trial is comparing microdosed atropine 0.01% versus placebo ophthalmic solution. Enrollment is progressing as planned. Our agreement with Arctic Vision covers Greater China and South Korea. And while the original agreement was for micropine and microline, they also recently added Mitcambi as well. So Arctic Vision now licenses all three of our current programs. We are pleased that Arctic Vision recently had its micropene IND accepted in China and is completing a PK study and preparing to start their phase three study. So that program is also progressing nicely. To date, our license agreements have generated approximately $16 million in license fees, and we have the potential to earn an additional $85 million in license and development milestones and reimbursable expenses over the next four years. Upon commercialization, if approved, we can also earn significant sales royalties as well. Development is progressing and we are seeking additional licensing partners for other key geographical territories. We are also continuing to assess potential pipeline expansion opportunities as we believe we can leverage the OptiJet technology to address unmet needs and additional large ophthalmic indications. As we indicated last quarter, Some examples include anti-infectives, anti-inflammatories, dry eye, and glaucoma, each with significant market opportunities. Now I would like to review our financial results for the three months ended September 30th, 2021. For the third quarter of 2021, we reported a net loss of approximately $5.6 million or 21 cents per share on approximately 26.1 million weighted average shares outstanding. And this compares to a net loss of approximately $5.1 million with 23 cents per share for the third quarter of 2020 on approximately 22.2 million weighted average shares outstanding. R&D expenses totaled approximately $3.5 million for the third quarter of 2021. And this compares to approximately $3.4 million for the same period in 2020, an increase of approximately 3.2%. For the third quarter of 2021, G&A expenses were approximately $2.4 million, compared with approximately $1.7 million for the third quarter of 2020, an increase of approximately 40.1%. Total operating expenses for the third quarter of 2021 were approximately $5.9 million, compared to total operating expenses of $5.1 million for the same period in 2020. This represents an increase of approximately 16%. Operating expenses also included approximately $777,000 of non-cash stock compensation expense. As of September 30th, 2021, the company's unrestricted and restricted cash balance was approximately $21.4 million. Our current unrestricted and restricted cash resources are approximately $30 million, And we believe this provides the company with sufficient cash to fund all our programs through 2022 due to the anticipated reduced spending with the delayed launch of Mitcambi. Therefore, we expect our current cash resources will be sufficient to bring out Mitcambi Medriasis product through the NDA process and commercial launch, complete our Presbyopia clinical program for MicroLine, and complete the preparation of our pilot manufacturing facility. In closing, we continue to be pleased with our performance to date. To summarize our key highlights today, we are continuing to rapidly advance our Phase 3 PRESS-VLBA program. We recently initiated a second Phase 3 trial, Vision 2, with top-line data expected in mid-2022. We are actively preparing for the resubmission of our MCOMB-NDA in the first quarter of next year, which if approved, will give us our first commercial product and validate our OptiJet dispensing technology. Our licensing agreements with Arctic Vision and Bausch Health are progressing well and continue to offer the potential for meaningful development of regulatory milestones, potential non-dilutive funding that we can use to expand and advance our pipeline of novel therapeutics leveraging our MAP technology. We believe we are well positioned to achieve multiple commercial regulatory and development catalysts this year and next for the benefit of shareholders and patients alike. That concludes our prepared remarks. We would now like to open the call to questions. Operator?
spk01: Thank you. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. And for participants using a speaker phone, it may be necessary to pick up the handset before pressing the star keys. Our first question is from Tim Chang with Northland Capital. Please proceed.
spk02: Oh, thanks. Sean and Michael, maybe you could just talk a little bit about the resubmission process. for mid-COMB. What exactly do you have to basically refile to the FDA with this reclassification? Is there any additional safety data that you have to provide to the FDA with the resubmission?
spk05: Hi, Tim. This is Sean. I'll try to take that. It's exactly as we mentioned, and I think Michael went into some detail. I don't think we can provide too much granularity But to your point, I think we can answer clearly that there is nothing that has to deal with either the safety or efficacy. And it's nothing that really concerns the clinical data. It's really more procedural in nature. And it has to do with the validation verification type of activities required on the device side, which we're very familiar. In fact, we have dual quality systems that we've maintained for that very reason. Again, we are not going to really go into too much detail because we're working very actively to fully understand every single item and coordinate and have a call with the FDA so that we can make the resubmission as quick as possible. But, you know, it doesn't change anything about the performance of the device, of how the device works, or the clinical utility and the clinical performance. It's mostly on the validation verification side for the device.
spk02: I see. Okay. And then maybe just one follow-up, you know, obviously Allergan's pilocarpine product recently got approval. I was looking at their label and I guess the treatment effect from their studies versus the vehicles around, I don't know, give or take 20% treatment effect. Do you think that you'll have comparable rates of efficacy with your microline product? And is, that sort of treatment effect about the same as what you've received in the Vision 1 study?
spk05: Right, so we've reported the results on the Vision 1 study and those are publicly available. I would really hesitate to speculate about our overall data in Vision 2, but on the flip side, we're gonna have that very quickly and very soon. I think Ginger from the operations team is very optimistic we'll be able to enroll this study fairly quickly, even quicker than Vision 1. There is such high interest in the field of presbyopia. There is such high availability of patients, and particularly when it comes to the OptiJet, there is really a competition for CISA competing to really get into the study because they appreciate how unique that technology is in that particular indication. And especially as we reported in the Vision 1, that we got only a less than 2% rate of headaches which we know with the overdose or the topical treatment with the eyedropper, that is more in the vicinity of 12 to 14, 15%. So I think there's a lot of things that we're encouraged by and very excited when we've seen and reported our Vision 1 data. We want to validate that with Vision 2. And ultimately, again, the mid-comb part will We hope once we address that, it will not impact in any way the first biopia pyelocarpen program for us. And we're very excited that Allergan is really validating that and has the pharmacologic therapy now on the market, developing the space for follow-on therapeutic.
spk08: Tim, I want to add something to that. You correctly point out that the delta between the three-line or 15-character improvement And placebo was 20%. And that's what's required for the FDA approval. But in this market, even a two-line, 10-letter improvement could be the difference between I can read my cell phone and I can't read my cell phone. So, you know, you have the barrier or you have the bar that you have to get over for the approval, which is very high. But an actual benefit for a patient, many, many more patients will benefit even from the lower bar to do, for example, with our product on demand to get you functional vision to get you that functional benefit. So, you know, I just want to make it clear there's what's required by the FDA versus what it is that patients are going to be happy with.
spk02: Okay, that's really helpful. Thanks, Sean. Thanks, Michael, for the additional color. Sure.
spk01: Our next question is from Matt Kaplan with Leidenberg Thalmann. Please proceed.
spk04: Hey, guys. Thanks for taking the questions. I just wanted to follow up on the refiling for McConvey. If you look at the data and info that you already have in hand with respect to validation and verification, how much more work do you need to do from de novo or from scratch to be able to refile? I guess, where are you in that process, do you think?
spk08: Hey there, it's Michael. I would say that we probably have 95% to 99% of it already. And where we don't, it's not like we have to do a clinical study. It may be just going back to look up the reg and then finding the validation studies that we had done and rewrite it to match whatever that regulation might be. So there's nothing in terms of any clinical that we need to do. And right now, it really is going through all of the validation reports that we've already done and where there might be a piece or two missing, we just fill in the blanks for that. Okay, that's great.
spk04: And when you refile, what's your expectation in terms of a Class 1 or a Class 2 review at this point?
spk05: Yeah, so Matt, I would love to answer this, but probably the best time to do it in the next call when we have some feedback from the FDA. I would hate to speculate now, And also what Michael said is absolutely correct, and we're very encouraged by the fact that we do have the majority of the data. And this is partially because our team, and we've said that before, that we've maintained dual quality systems and a lot of our engineering data and processes have built-in verification validation because the fact that the FDA reclassifies us does not make us less or more of a device than we've always been when it comes to utilization in the field and how this has to be made. It has to be made with all the appropriate quality control systems because ultimately it will be used by the patient. The part that we don't know is obviously the FDA will have an additional review team or additional reviewer from the device side and one part from us that's really unclear is given what we've developed on our own and what we have created following all of the device regulations and specifications, you know, how acceptable and how that would really be in line with their expectations because we've never had discussions with anybody from the device side. So, again, there's a couple of things that we want to absolutely ascertain before we provide information or come back to you with something that may or may not be true. It may turn out that it's a very easy thing, but having dealt with the regulations and the FDA before, it's always important to have very specific feedback, and we intend to get back to them very quickly, addressing all their points and showing them the information we already have to make sure that we can expedite that.
spk04: Okay, and that makes sense. Thanks. And then a follow-up on the micro... line program, given the recent approval of Allagan and I guess the evolving competitive space in terms of Presbyopia and other programs out there. Can you talk about the differentiation of MicroLine versus other programs?
spk08: Sure, Matt. The differentiation is going to be on which of these products best match the the patient's lifestyle. If you go to an optometrist and I believe they will be the principal prescriber of these, these are generally patients who've never been into their offices before because their entire life they've never had to wear glasses. So now they're coming in because they're having trouble with near vision and they're looking for options and what they don't want is to turn, you know, presbyopia into a disease. They want something that's as easy to use as glasses, but it's not glasses. They're looking for like invisible glasses. And what Microline will give them is that ability to manage presbyopia so that they can use the product when they would like to in a way that they would like to, easy to use, and something with minimal side effects. And I think that's one of the biggest differentiators. So the ability to use it on demand, number one, instead of having to take it every day, because right now people don't take their medications every day, to have a very low side effect profile. would be the other differentiator. And the third one would be to make it easy and convenient for them, which the dispenser does. And I think that will make a real difference in the market research we've done. Once you put the OptiJet into somebody's hands, that's really all you have to do. It makes all the difference in the world when they see how good that technology is. Okay. Makes sense. Thanks, Sean. Thanks, Michael. Thank you.
spk01: Our next question is from Len Yaffe with Stock Dock Partners. Please proceed.
spk03: Thank you very much. Yeah, Mike and Cheyenne, just wanted to have you go over again what I think is the critical point as it relates to microline. This, as you've talked about before, is a cosmetic product where people are often going to be using it in social situations, such as not having to wear reading glasses, going out to a restaurant, or being at an event. where they're going to be photographed and they don't want to have to be photographed with glasses. And therefore, the incidence of side effects with a cosmetic is the greatest deterrent because people don't want to feel bad for a cosmetic gain. So I was just wondering, as I understand with Allergan, their AEs, their adverse events greater than equal to 3% in their trial included headache, blurred vision, eye pain, and hyperemia. And obviously, as it relates to being photographed, hyperemia would be a significant deterrent. Could you discuss your specific adverse event profile that you've seen and to the extent that you think that this is an important differentiation? Thanks so much.
spk08: Sure, Len. I'll start with hyperemia because pilocarpine doesn't generally cause hyperemia. So even though it showed up in their trial and Trace2Mile showed up in ours, At least in our case, it showed up because we asked people to look for it. So we specifically asked the investigators, do you see any hyperemia? And then I think something like 20% of cases, they said, yes, trace the mild for that. And it was transient and disappeared very quickly. I think the big one is going to be the headache or browache. And that is directly related to how much drug you put onto the eye. Because what happens is you put excess drug, it gets into the local circulation and and you get the muscle between the eyes tensing up, and that's the brow ache, and that is directly in relation to how much drug you give. And so not surprisingly, what Allergan saw, I believe, in one of their trials was a headache or a brow ache rate of about 14.8%, something close to that, which is what you see for pilocarpine in general and would be what's expected. And in our trial, we saw about 2%, and that's because of how much drug you're putting in. And I agree with you that the headache could be classified as transient or minimal, but it's probably something most people don't want to even have to bother with. So I see that as a key differentiator between us and any of the drop products. Thank you.
spk03: And sure, then just as a follow-up, as it relates to pediatric progressive myopia, which is virtually an epidemic worldwide and has been exacerbated by COVID-19 with kids staying inside more and looking at near-term computers or cell phones. How long a study do you think that will be, and where do you think you'll be positioned competitively versus any others who may be looking at this market, which I think could end up being far larger than presbyopia?
spk08: Yeah. That's a great question because I'm here at the Accelerator meeting in New Orleans, and We just had a myopia panel that Sean was a part of, and this is a big discussion. You know, the studies are three years with a fourth year in there as a follow-up that's required by the FDA, and they're staying firm on that. There are two eye drops ahead of us in Nexus and Nevicar, and then we come out. And then the other products that are coming are just going into phase one, so they're years and years and years away. I'm not particularly concerned if we come out a year or a year and a half behind the drops. Number one, there's plenty of patients coming in, new patients all the time. Like you said, it's an epidemic. There are literally millions and millions of these kids, unfortunately, who are going to be available. Secondly, it's a kind of therapy that once we do come out, if it's the better mousetrap, and I believe it is, they can be switched because they'll be going from an atropine drop to an atropine in the OptiJect dispenser where some of the benefits they may have get because of that is lower systemic absorption which is always nice for kids and it's more comfortable because you're taking less it doesn't sting and also because the device itself can track compliance and adherence to therapy which you know if the kid is not using the drug then they're not going to get the benefit so that's something else that can help them as well so right now I think we'll probably be number three a close number three But again, such a big opportunity, unfortunately, that it's not something that terribly concerns me.
spk03: Great. Thanks so very much.
spk08: Thank you.
spk01: With no more further questions, I would like to turn the conference back over to Sean for closing remarks.
spk05: Yes. Thank you, everybody, for listening in. And we look forward to our next update next quarter. when we'll have a lot more information, and hopefully everybody has, in the meantime, a happy holiday season. Thank you.
spk01: Thank you. This does conclude today's conference. You may disconnect your lines at this time, and thank you for your participation.
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