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spk08: Greetings. Welcome to the INOVIA fourth quarter and full year 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 turn the conference over to your host, Eric Ribner. You may begin.
spk07: Good afternoon and welcome to INOVIA's fourth quarter and full year 2021 earnings conference call and audio webcast. With me today are INOVIA's Chairman, Chief Executive Officer and Chief Medical Officer, Dr. Sean Ianculez, Chief Operating Officer, Michael Rowe, and Chief Financial Officer, John Gandolfo. This afternoon, INOVIA issued a press release announcing the financial results for the three and 12 months ended December 31st, 2021. 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 31, 2021, which was filed at the SEC. The company's press release and annual 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 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 Security 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 and the Russian invasion of Ukraine, our ability to raise additional money to fund our operations for at least the next 12 months as a going 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, implement, and maintain manufacturing, commercialization, and marketing capabilities and strategies for our product candidates. Risks of our 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 result in social distancing. Timing progress in the results of such trials. The potential impact of COVID-19 and the Russian invasion of grain are related economic disruptions on our supply chain, including the availability of our sufficient components and materials used in our product candidates. The timing of our licenses, ability to submit application for, obtain, and maintain regulatory approvals for our product candidates, changes in the legal, regulatory, and legislative environments and the markets in which we operate, and the impact of these changes on our ability to obtain regulatory approval for our product candidates, 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 the qualified by the cautionary statements contained in Inovia's press release and SEC filings. This conference call contains time-sensitive information and is accurate only as of the date of this live broadcast. I know the undertakes no obligation to provide forward statements to affect events or circumstances after the date of this conference call, except as may be required by applicable law. With all that said, I'd like to turn the call over to Dr. Sean Iancule.
spk04: Thank you. Thank you, Eric. And welcome, everyone, to our fourth quarter and full year 2021 financial results conference call. We're excited to recap a very productive quarter and year during which we made significant progress across both of our clinical programs. Regarding MidCombi, we are working to complete the OptiJet device validation work that had been previously requested by the FDA and remain on track to resubmit the NDA in the third quarter of this year. We're assuming a six-month review cycle and are making plans for a targeted launch if approved for the first half of next year. At the same time, we continue to enroll our second Phase III study, Vision 2, for our microline presbyopia program and anticipate data next quarter. If positive, we plan to begin manufacturing our registration lots to support stability and commercial expiration dating as a requirement for an NDA of Microlines. Importantly, the device validation work that we're now completing for MidCombi may be referenced in regulatory filings for our other programs that also use the OptiJet, including Microlines, potentially streamlining the FDA review process for those product candidates after other data requirements are also fulfilled. These are exciting times at Inovia, as we believe we have a clear line of sight to two commercially approved products, both leveraging our proprietary OptiJet dispensing technology. As Michael will discuss in a moment, we also demonstrated empirically for the first time in vitro that delivery of ophthalmic medications with our microarray print delivery system can provide similar benefits to the conjunctiva as our as other non-preserved medications. The importance of this finding cannot be overstated. The OptiJet technology is a key differentiator for us. We leverage it for all of our pipeline programs, as well as Micropin, which, as you may recall, has been outlicensed to Bosch Health and Arctic Vision. At this point, I will turn the call to Michael for an update on our operations. Michael.
spk03: Thank you, Sean. As you mentioned, the Inovia teams have been very busy working on demonstrating the value of our technology and preparing for future commercial-scale manufacturing across the product line. One of those value drivers is potentially improving ocular surface safety and comfort due to our microdose array print technology. As you may know, the vast majority of topical ophthalmic medications contain preservatives to help ensure the sterility of the product and to increase its shelf life. However, many patients on chronic treatments such as for glaucoma or dry eye often experience adverse effects in ocular stress in the long term due to the toxicity from overexposure to these preservatives. With the OptiJet, we have demonstrated something that, to our knowledge, no other delivery technology has achieved, namely to limit the negative impact of ocular preservatives and to transform a preserved formulation into a non-preserved therapeutic profile without any reformulation. The evidence for this comes from a study we recently conducted in collaboration with Dr. Pedram Hamra at Tufts Medical Center. The purpose of the study was to compare the impact of the most commonly prescribed preserved glaucoma medication delivered by the OptiJet versus the same medication delivered in the traditional eye drop. We also compared ourselves versus non-preserved medication delivered by eye drop. We looked at the impact of these medications on human conjunctival cells to assess toxicity and metabolic impact. The results of this study demonstrated that human conjunctival epithelial cells tolerated preserved drug treatment administered by OptiJet spray better than the same drug administered by a standard eye drop, and similar to a non-preserved drug treated cell line, added control with respect to cell viability, cytotoxicity, apoptosis, and metabolic activity. Why is this important? Because all else being equal, non-preserved topical ophthalmic medication is the preference as it is better for the long-term health of the eye. However, today's non-preserved medications are often provided either in inconvenient and difficult-to-use unit dose vials or in clumsy bottle-like devices that filter out the preservative. The ability of the OptiJet to provide the same benefit as these non-preserved options, but in a dispenser that makes administration of the drug easier, more comfortable, and without inducing ocular stress is a big win. and opens the door to products with superior profiles for use in chronic disease states such as glaucoma. Another study we conducted to further demonstrate the value of our technology was called SPEED, and we will be presenting data from this study at the American Society of Cataract and Refractive Surgery Conference in Washington, D.C. next month. In short, SPEED demonstrated that the efficacy seen with a single optogen mist was not significantly different when you added a second spray establishing yet again, and even though our dose is just one-fifth out of an eye drop, that all you need to achieve similar clinical effect is one spray. Moving on to Microline, as you may recall, Microline is our proprietary microdose array print pilocarpine therapy for the temporary improvement in near vision associated with presbyopia, or otherwise for the treatment of presbyopia. A market representing over 18 million people in the United States between the ages of 40 and 55, who otherwise never wore glasses. Microline is unique in that it is designed to be used on demand, the way most people would like to use this type of treatment. Recall that Vision 1 demonstrated positive efficacy with a very low rate of browache or headache as compared to pilocarpine eyedrop formulations. We hope to replicate these same positive results in Vision 2, which is ongoing. Vision 2 is a Phase 3 registrational double-mask placebo-controlled superiority trial of 2% multi-array print and pilocarpine versus placebo. We aim to enroll about 140 patients into the study and anticipate top-line data around mid-year. Enrollment is tracking according to plan. We believe Microlign, if approved, will be a great step forward in the treatment of presbyopia. It will be highly differentiated from other meiotic presbyopia formulations. For one, horizontal on-demand delivery is a game changer for patients that are struggling with legacy eyedropper technology. In addition, microdosing is able to do something not readily achieved with a standard eyedropper, delivering a therapeutic profile with potential tolerability benefits. Conventional pilocarpine eyedrops, such as the one recently approved, can cause headache in 15% to 20% of patients. With the OptiJet, we saw this rate reduce to less than 3% in our Vision 1 trial. Also, as mentioned earlier, the study of ocular surface toxicity with preserved microdose formulation shows equivalence to preserve the free macrodose. This potentially means a healthier ocular surface with long-term use. Presbyopia, with its multi-billion dollar market opportunity, has one of the largest addressable markets of any ophthalmic condition. Allergan recently launched the product Viewity, which uses the same active ingredient as Microline and has a broad direct-to-consumer advertising campaign to raise awareness of the product and the fact that there is a pharmacologic treatment for presbyopia available. Over the last two years, we have compiled a significant body of market research indicating strong consumer and prescriber preference for the OptiJet dispenser. So while we are pleased that Allergan is creating a market for pilocarpine-based presbyopia treatment, we ultimately believe that Microlign, if approved, will better address what patients and prescribers actually want and the product for this indication. We remain very bullish on Microlign and believe it has the potential to be a significant long-term value driver for Inovia, as well as our Chinese and Korean licensee, Arctic Vision. Combined with the positive clinical data generated to date, our upcoming results for Vision 2, and the significant benefits of OptiJet, we believe Microlign could be transformational ophthalmic therapy upon its approval. We had previously discussed changes that were being contemplated at the Centers for Medicare and Medicaid Services regarding potential reimbursement for remote therapeutic monitoring, or RTM. RTM gained widespread acceptance during the peak of the COVID pandemic, and as a result, new reimbursement codes were approved for RTM beginning in January of 2022, one of which we believe is applicable for ophthalmology. Such remote monitoring allows training physicians to gather compliance and adherence data in real time, ultimately leading to better patient care between office visits and or avoiding unnecessary office visits. Our OptiJet dispenser is purpose-built for such remote monitoring and therefore has the potential to become a go-to option for the remote therapeutic monitoring associated with topical ophthalmic drug adherence and compliance. Combined with the potential benefits to the ocular surface that we just discussed from the TUF study, the reduced systemic impact of drugs seen in our published studies, and the ease of use versus standard eyedroppers, we believe we have the potential to partner with companies who want to leapfrog ahead in chronic disease management. Remote therapeutic monitoring can open a new pathway for smarter, more personalized eye care with real-world benefits for patients with chronic diseases such as glaucoma, while also potentially enabling doctors to get compensated for their patient management. We look forward to providing further updates on their progress on future calls. Turning now to manufacturing, in preparation for the commercialization of Bencomi and Microlign, if approved, we are finishing validation of our fill and finish drug facility in Redwood City, California, and are preparing to install equipment that will allow us to have better control over the logistics and costs for device production in Reno, Nevada. The same equipment would also help us efficiently supply our partners, Arctic Vision in China and Korea, and Bausch in the U.S. and Canada, as they continue their clinical programs. I would now like to turn the call over to our Chief Financial Officer, John Gandolfo, to provide a financial update. John? Thank you, Michael.
spk05: Subsequent to the end of the fourth quarter, we further strengthened our balance sheet through a $15 million equity investment from Armis' Capital Master Fund. Together with our cash position as of December 31st, 2021, our pro forma unrestricted and restricted cash position as of today is approximately $35.7 million. We believe this is sufficient to bring our Mitkambi-Madriasis product candidate through the NDA process and commercial launch, complete our Presbyopia clinical program for MicroLine, and complete the preparation of our pilot manufacturing facility in Redwood City, California. Now I would like to review the financial results for the three and 12 months ended December 31st, 2021. For the fourth quarter of 2021, we reported net income of approximately $3 million or 11 cents per share on approximately 27.9 million weighted average shares outstanding and 10 cents per share on approximately 30 million diluted basis shares outstanding. This compares to a net loss of approximately $4.2 million or 17 cents per share for the fourth quarter of 2020 on approximately 24.9 million weighted average shares outstanding. For the full year 2021, net loss was approximately $12.8 million or a loss of 49 cents per share. And this compares to a net loss of approximately $19.8 million or a loss of 94 cents per share for the full year 2020. Research and development expenses totaled approximately $3.2 million for the fourth quarter of 2021, and this compares to approximately $3.4 million for the same period in 2020, a decrease of approximately 6.5%. For the full year of 2021, R&D expenses increased 8.6% to approximately $14.5 million, and this compares to $13.4 million for the full year of 2020. For the fourth quarter of 2021, general and administrative expenses were approximately $3.7 million, compared with approximately $2 million for the fourth quarter of 2020, an increase of approximately 84.7 percent. For the full year of 2021, G&A expenses increased 41.5 percent to approximately $10.8 million, and this compares to $7.5 million for the full year of 2020. Total operating expenses for the fourth quarter of 2021 were approximately $6.9 million compared to total operating expenses of $5.4 million for the same period in 2020. This represents an increase of approximately 27.4%. For the full year of 2021, operating expenses increased 20.6% to approximately $25.3 million compared to $21 million for the full year of 2020. 2021 operating expenses included approximately $2.9 million of non-cash stock compensation expense. As of December 31st, 2021, the company's unrestricted and restricted cash balance was approximately $27.3 million, which excludes the recent $15 million offering through Armistice Capital, which was completed in March. Before we open up the call to questions, I will conduct a brief update on our licensing programs with Bausch Health for Micropene in the US and Canada, and Arctic Vision for all three of our drugs in China and South Korea. Micropene, as you may recall, 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, multifocal glasses, or contact lenses are typically prescribed to myopic children. Recall that as part of this agreement with Bausch Health, Bausch 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 microdose dactropine 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 clearance in China, is completing a PK study, and is preparing to start its phase three study. So that program is also progressing nicely. To date, our license agreements have generated $16 million in license fees, and we have the potential to earn an additional $60 million in net license and development milestones and reimbursable expenses over the next four years. In addition, with the transfer of the chaperone clinical study and related costs to Bausch, our clinical trial expenses will be reduced by $3 to $4 million per year from originally anticipated levels since we are no longer responsible for these expenses. Upon commercialization, if approved, Inovia can earn significant sales royalties as well. 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. Some examples include anti-infectives, anti-inflammatories, dry eye, and glaucoma, each with significant market opportunities. In conclusion, we continue to be pleased with our performance to date. To summarize our key highlights today, We are continuing to rapidly advance our Phase III microline presbyopia program, and we are enrolling patients in the first patient in our Phase III trial, Vision 2, and expect top-line data this year. We are actively preparing for the resubmission of our Mitcambi MBA in the third quarter of this year, which, if approved, will give us our first commercial product and validate our OptiJet dispensing technology. In parallel, we are continuing to expand the body of research on OptiJet, as shown by the remarkable findings in our collaboration study with Tufts that highlighted the significant potential of OptiJet to bypass common adverse events associated with chronic ophthalmic therapy use. And our license agreement with Arctic Vision and Bausch are progressing well and continue to offer the opportunity for meaningful development in regulatory milestones. as well as line of sight to potential sales royalty, possibly within three to four years. That concludes our prepared remarks. We would now like to open the call to questions to the operator.
spk08: Thank you. At this time, we will be conducting a question and answer session. 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. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start key.
spk09: One moment, please, while we poll for questions. Our first question comes from the line of Matt Kaplan with Lattenberg-Dalman.
spk08: Please proceed with your question.
spk02: Hey, guys. Thanks for taking my questions, and congrats on the progress. Just wanted to, you know, with the, I guess, relative near-term resubmission of the Midcombi NDA and approval in the first half of next year, how should we think about the potential launch of that product as we head into next year?
spk03: Hey, Matt, it's Michael. Good to hear from you. Okay. The launch is going to be very targeted. This is a brand-new technology, and we want to make sure that our potential customers have a great experience as we roll it out. So the way I would think about it is that we're going to start and keep the expenses low, and we're going to pay for it as we go along. So, for example, what you won't see is 100 salespeople being hired by the company. You'll see us starting out at the highest population centers, and once that is successful, then going out from there. So I would say that our expectation would be a targeted, controlled launch, but one where the expenses are very controlled so that we're not going to get ahead of our skis and end up upside down with this.
spk02: Okay, that's really helpful. Thank you. And then I guess with the Vision 2 study now ongoing and results expected soon, can you talk a little bit about the differentiation of microline versus microline? other products for Presbyopia either in development or I guess allogams as well?
spk04: Yeah, Matt, this is Sean. And I think we've discussed that we're very passionate about the differential approach that MicroLine represents. It really incorporates the distilled value prop of our entire technology. Here we go, for example, we have a drug like pilocarpine that's used by Allergan today and other companies. But when you deliver it on the microdose technology with the OptiJet, it really inflects the therapeutic index of that compound. What does that really mean? Again, probably the most, the first pass, differentiation is obviously you can deliver something that you can get into the eye in a very easy way and the convenience should not be underestimated particularly for a population like the 40 50 year olds who who still haven't been trained they're not like the glaucoma patients who are being trained and trying to get accustomed to use a legacy eyedropper technology that half of the time they cannot even get into their eyes so obviously the convenience the the streamlined delivery The fact that we're using modern-day technology and a smart delivery technology is huge. But I think another part is really important, is topical and systemic safety. In our trial for Vision 1, we saw that the rate of headache, which is very well established, and even before the presbyopia studies, we know from the glaucoma literature it's about 15% to 20% of patients have a headache, and that becomes very key when you're using something of a more cosmeceutical type of nature. So headaches in the Allergan trials, I think, were reported about 15% or so, which is very consistent with the literature. With microdosing, we're seeing the same thing we're seeing with some other compounds, as we've demonstrated before for hyperemia, for example, with ROCA inhibitors, where we are able to reduce that dramatically. Here, we're seeing rates of about 2.5%, below 3%. And again, we think that's key, and it's come up. Michael has done a number of marketing surveys and user surveys and patient surveys that show that headache is something people don't want to get when they're trying to address their near vision. So again, hyperemia and other things are really important. I think we really demonstrated something that I've always wanted to do, Even in the early stages of the technology, we finally were able to get to do the study for the ocular surface tolerability to show that a preserved microdose behaves and offers the same therapeutic profile as a non-preserved, where people have to carry those unit dose containers with them everywhere they go. They carry too many things as it is. So having a multi-dose preserved that behaves as a preservative-free is a huge differentiator as well. And that, again, all of these are not just for Microlion. They carry through the entire platform for anything else we want to do or are doing, such as Micropene as well.
spk02: Okay, yeah, that's really helpful, Sean. Thanks for that detail. And I guess last question, and you did well, you know, last year with milestone payments totaling $14 million. What are you expecting this year for potential milestones from partners?
spk05: So we are not expecting any license fee milestones this year. We will continue to receive reimbursable expenses associated with some of our product development work, as well as clinical study. And to the extent that we are supplying our partners with clinical study units or clinical study supply of OptiJets will continue to receive reimbursement there. But nothing on the license fee side for this year. Okay. Okay.
spk09: Fair enough. Thanks again, guys. Thank you, Matt. Our next question comes from the line of Tim Chang with Northland Securities.
spk08: Please proceed with your question.
spk06: Hi. Thanks. Assuming the Vision 2 study is positive, when could we expect you to file microline? Would that be a second half of the year filing, or do you think you'll need to do an additional study on top of what you've done with Vision 1 and Vision 2?
spk04: Well, yeah, that's a good question. I think, again, this would be We hope to see a positive Vision 2 Phase 3. And again, we are planning to launch ultimately the Vision 2 and the microline on the Gen 2 streamlined and improved delivery platform. We're going to do that because the Gen 2 offers some very key advantages when it comes to the consumer side. It's much more elegant and it's something that we've planned all along. Before I commit to you and tell you exactly what we're going to do, I think we want to check in at the end of the Vision 2 with the FDA just to make sure we make some confirmations. And as you know, we're also, we'll be towards the second half of this year, we will be also marching towards the filing and the resubmission for the NDA. So as much as I would like to answer specifically your questions. Most importantly, we want to sync up with the FDA and make some confirmations because we know that certain timelines changed after they made some changes to their classification. And we are now a drug-device combination. And the transition from the Gen 1 to the Gen 2, certain things we want to confirm before we give any guidance on that. But again, we hope that the Vision 2 is positive and really confirms the Vision 1. And if there are any bridging things that need to be done, we'll have to confirm those. Hopefully not. And after we do that meeting with the FDA after the Vision 2 results, we're going to revisit and give you guys more detailed information about that.
spk03: I think we can also add, Sean, that what we said in the comments earlier was that one of our next steps is we're making registration batches for microlines. So, Tim, you know, We're going to start those as soon as we have a positive, see some positive results. So that will be the beginning of making those batches. So that will help you with kind of estimating what that timeline would be.
spk06: Okay. And maybe just to clarify, I know you guys showed some data on your spray formulation being comparable to dropped batches. formulations that are preservative-free. Are you guys working on your own preservative-free formulations as well or not?
spk04: Well, good question, Tim. We made this decision a long time ago when we had to really think through what the true benefits of microdosing are. And right now we are seeing, and we've proven now even further with this data, that we're seeing what we saw with some of the patients, that they see very little discomfort from microdose-preserved formulations. And we saw that in MIFT1, we saw that in MIFT2, in PG21. And this really confirms not only the data that we were seeing from the patients, it just confirms on physiologic level and a cellular level. So I would say we're seeing very little motivation to pursue preservative-free formulations given that the preservatives behave the same way. On top of that, there are some data that are very well known in the ophthalmic literature that when you go to a preservative-free formulation in an eyedropper, for example, you may take that with a trade-off of efficacy. And we've seen that with some of the glaucoma formulations. Why? Because the preservative may be important, a little bit of preservative may be important to open up the epithelial cells and increase penetration through the cornea. So I think at this point, to sum up, I think we're very happy that we're really proving out that microdosing a preserved formulation is the way to go, not only for direct targeted delivery, not only for tolerability, now we're seeing it at a cellular level as well, And I don't think we see any major drivers here to switch to preservative-free. That being said, I think that we don't say that our technology is not able to work with preservative-free formulations in the future should we want to do that.
spk06: I see. And, Sean, I promise this is the last question. You know, when you guys show your vision... Take your time.
spk01: That's fine. No problem.
spk06: Oh, thanks. Thanks, Sean. When you show your vision to results, will you provide more of the details on, for instance, some of the comparable efficacy parameters so that we can sort of compare it to VWIDI? Obviously, I think the market's going to want to see that, right? I mean, will you be able to show some sort of apples-to-apples data on efficacy?
spk04: Right. So we obviously have mentioned what our endpoints are and actually we've given some data at the encouragement of the interested parties and stakeholders from Vision One. I think that we want to see the data. We are going to share it. We will have to present it also at the peer review venues. We haven't committed one way or another whether we're going to change the way we present the data from Vision One. I think we gave a lot of guidance there. Most importantly, we want to meet the endpoints and we also want to keep the key safety factors for which we've given very detailed information. And again, we want to make sure that whatever we do is consistent with our best-in-class regulatory approach. We don't want anything to necessarily jeopardize the the NDA submission. And ultimately, we're, again, coming second or third on the market with that. We'll be able to internally compare it and control to some degree how much we're going to inform the competition on that. So it's a long-winded answer of saying we haven't really decided if we're going to change the exact paradigm, although I do feel at Vision 1, we did provide increasingly more data and visibility to our endpoints.
spk06: Okay. Okay. Thanks. Thanks, Sean.
spk08: Sure.
spk09: Thank you, Tim.
spk08: And again, as a reminder, if anyone has any questions, you may press star 1 on your telephone keypad to join the Q&A queue. Our next question comes from the line of Glenn Yaffe with StockDocPartners. Please proceed with your question.
spk01: Thank you very much. I had two questions for you guys. The first is I was really – interested in hearing, because it's something I always thought there was tremendous value in, about the possibility of expanding the applications of the OptiJet delivery system. And you mentioned four conditions, I believe three of which are extremely large, but they're competitive. And in the glaucoma case, there were several generics. I was just wondering, are these indications, and maybe it's a mixture that you intend to develop yourself from existing medications that are out there available generically, either as monotherapy or as combo therapy, or is it a technology that you plan on licensing to those companies who maybe have patented products in one of these areas? My second question is you talked about maybe having to do some sort of bridging study, if I heard right, after Vision 2 as it relates to getting approval. And I was just wondering, from Michael Line, and I was just wondering, I believe back in January you had stated that you expect the product to be on the market in the second half of 23. Would this alter if anything has to be done either to justify the second generation device or anything else that the FDA may want? Could this alter that timeline for when you might get on the market? Thanks so much.
spk04: Right. Len, thank you. Very, very good questions. I'll start with the first one. I think that it's really, we're very encouraged to see that we can have a purchase on many, many formulations and applications within the topical space for ophthalmic pharmaceuticals. And we really can provide a number of huge value props from glaucoma to, as we have now with microlinin, presbyopia and progressive myopia and mycopene. Again, being a small company at the valuation where we are right now, unless that changes materially, our preferred approach will be to really partner new indications and new applications. And at the same time, we are exploring things we can add to the pipeline with the same meaningful approaches we did with the presbyopia and progressive myopia. I think the reason we chose those were not just because they were available entities that we can put on our system, but really they opened up huge indications, big unmet needs where we can pivot into this technology and we can really inflect the therapeutic index of those formulations. So our preferred approach would be to really use the approval of one day, hopefully with the Gen 1 and the mid-combi, to really catalyze our business development and partnerships. And I think that would be a fair statement to how we feel the immediate horizon is for us. On the Vision 2, we would love, if there are no changes, and if we just approach this in a very linear and the most direct vector, we would love to to be on that timeline for the mid-2023. But again, as we consider all the facets of this development and the drug and device, I think it will be premature to commit to that before we see the results of the Vision 2 data and we go to the FDA for confirmation. As well as we see how the registration batches also pan out because those, as we know, we've waited for registration batches before. We have not activated too many things at risk, given that we're small and we're very budget conscious. So we definitely will, in this case, use the sequential approach. We want to see the Vision 2 data and then activate some of the registration batches, which is really connected with significant expense for a small company like we are. Michael, do you want to add anything else? No, I think that's exactly right. Okay, thanks.
spk01: Thank you.
spk04: Thank you, Len.
spk08: And we have reached the end of the question and answer session. I'll now turn the call over to Dr. Sean Ianchula for closing remarks.
spk04: Thank you. Well, great. This was a pretty substantive call, and I think we provided a lot of updates, particularly on the finances and on the operations. Again, we hope that you take away from today's call that last year we made significant progress on all fronts, and I believe this is the year that it all comes together. We have set ourselves to achieve a number of clinical and regulatory milestones in the near term, and we're working diligently to advance the two main programs, Mitcombi and Microline, towards NDA submission and potential commercial approvals for the U.S. market. That concludes today's call. We look forward to our first quarter update in May. And thank you all for joining, and have a good afternoon. Thank you.
spk08: And this concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.
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