Q3 2024 Eyenovia Inc Earnings Call
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: Good afternoon and welcome to Inovia's third quarter 2024 earnings conference call and audio webcast.
Speaker Change: 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.
Speaker Change: This afternoon, we issued a press release announcing financial results for the three months ended September 30, 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 30, 2024, which was just filed with the SEC.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: We caution listeners that during the call, Inovia's management will be making forward-looking statements.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, November 12, 2024.
Speaker Change: 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.
Speaker Change: With that said, I'd like to turn the call over to Michael Rowe, Inovia's Chief Executive Officer. Michael, the floor is yours.
Michael Rowe: Thank you, Eric, and welcome everyone to our third quarter 2024 Financial Results Conference Call.
Michael Rowe: 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.
Michael Rowe: 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.
Michael Rowe: 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.
Michael Rowe: 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.
Michael Rowe: Pediatric progressive myopia is increasingly recognized as an epidemic in both the United States and globally.
Michael Rowe: 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.
Michael Rowe: 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.
Michael Rowe: The side effects of atropine dosed with the optogen 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.
Michael Rowe: 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.
Michael Rowe: 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.
Michael Rowe: Our engineers are working today on plans to validate the system as part of our anticipated future NDA submission.
Michael Rowe: We look forward to providing additional updates on this program during our upcoming KOL virtual event on December 11th.
Michael Rowe: 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.
Michael Rowe: 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.
Michael Rowe: including one-button use and compatibility with our digital compliance monitoring program OptiCare.
Michael Rowe: This greater efficiency translates to lower costs, helping us to achieve margins of up to 90% on our planned product line.
Michael Rowe: We view the introduction of the Gen 2 OptiJet as a significant upcoming inflection point for the company.
Michael Rowe: Now let's look more deeply into MidCombi. MidCombi is also very important to Inovia as it has derisked our OptiJet technology from a regulatory point of view.
Michael Rowe: We work very closely with the FDA to identify the various activities, studies, and validation processes necessary to get our device approved, allowing MidCombi to serve as the precedent for any other optogen-based product.
Michael Rowe: Obtaining FDA approval by itself was a terrific milestone for our company. We are now recognized as a leader of this technology with an eye care.
Michael Rowe: We also understand that introducing this technology into the market requires us to change the paradigm of using eye drops.
Michael Rowe: We found that after using Medcompi 50 times, which translates to about a week, both doctors and technicians felt truly comfortable with the change from eye drops.
Michael Rowe: We also found that four out of five eye care professionals
Michael Rowe: 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.
Michael Rowe: In September, our founder and board member, Sean Ianchilev, 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.
Michael Rowe: 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.
Michael Rowe: 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.
Speaker Change: At this point, I'll turn the call over to our Chief Operating Officer, Bren Kern. Bren?
Bren Kern: Thanks Michael. At the end of September we announced the launch and commercial availability of clobetazole developed by our partner Formosa Pharmaceuticals.
Bren Kern: Clabetazole is FDA approved for the treatment of pain and inflammation following ocular surgery and the first new ophthalmic steroid to come to market in over 15 years.
Bren Kern: With its favorable efficacy and safety profile, convenient twice-a-day dosing regimen, and streamlined distribution designed to eliminate complications from insurance, we're seeing strong interest amongst doctors and have already placed cobetazole into local pharmacies supporting over 100 offices.
Bren Kern: Clabetazole perfectly complements MidCombi, our FDA-approved and commercially available midriasis agent, offering additional value to ophthalmic offices while maximizing the utilization of our 10-person sales force.
Bren Kern: Offices commonly show interest in both clovetazole and medcombi. The launch of clovetazole signifies a substantial step towards the execution of our commercial strategy.
Bren Kern: 100 ophthalmic surgeons were involved in this research and ranked efficiency and safety as the most important characteristics of post-operative steroids.
Bren Kern: In clinical studies of clobetazole, approximately 80% of patients had complete relief from pain as soon as four days post-surgery versus approximately 50% for patients who had vehicle.
Speaker Change: Inovia is addressing these concerns by offering clobetazole to patients at a low fixed price regardless of their insurance status. This is seen by surgeons as a great way to eliminate insurance complications that often burden their office staff.
Speaker Change: In summary, the majority of surgeons surveyed, based solely on the actual prescribing information and pricing, indicate a high level of interest in prescribing clobetazole.
Speaker Change: Turning now to our manufacturing facilities, recently we successfully completed two audits of a Reno Nevada facility, one by the Nevada Board of Pharmacy and the second by the FDA.
Speaker Change: Nearly 16 million Americans suffered from dry eye with treatment expenditures totaling over 3 billion in the US and 5 billion globally. Symptoms of dry eye can significantly interfere with daily life and many patients remain unsatisfied with available therapies.
Speaker Change: According to a recent survey by the American Academy of Ophthalmology, 48% of patients reported carefully following their treatment plans, but only 13% experienced lasting relief.
Speaker Change: We're excited about our collaboration agreements in the field of dry eye. In brief recap for Formosa, we signed an agreement to develop a formulation of Colbetazole in the OptiJet as a potential treatment for acute dry eye and other indications.
Speaker Change: This development program, which will require two 15-day clinical trials, will be free of any upfront fees from Inovia or development milestones to Formosa unless and until it receives FDA approval.
Speaker Change: For Senju Pharmaceuticals, we also signed a collaboration agreement to develop a new adjunctive treatment for chronic dry eye disease.
Speaker Change: We will work closely to develop Senju's SJP0035, initially intended to facilitate epithelial wound healing as a candidate for use with the OptiJet to treat chronic dry eye.
Speaker Change: This potential drug-device combination is unique as it is being designed for use alongside other dry eye medications.
Speaker Change: In other words, we believe it would complement existing products rather than competing with them.
Speaker Change: We are working towards requesting a meeting with the FDA later this year, followed by anticipated completion of a Phase 2B study in 2025.
Speaker Change: With these studies, SJP0035 was well-polarized, providing promise to support chronic dry eye indication.
Speaker Change: And finally, SDN. We entered into a collaboration agreement with SDN Nanoformer to leverage its proprietary Micellar nanoparticle platform known as the MNP platform.
Speaker Change: This platform allows for the distribution of active pharmaceutical ingredients in three or more phases, thereby improving its bioavailability, biodistribution, and pharmacokinetics.
Speaker Change: We have been conducting feasibility and manufacturing testing with SGN's phase 3 ready ophthalmic cyclosporine formulation, SGN 101, in combination with our OptiDET device as a potential treatment for chronic dry eye.
Speaker Change: This faster-working cyclosporine combined with the OptiJet dispenser could be a powerful new treatment option for this large underserved market. With the SDN collaboration, we are hopeful that we may have a Phase III-ready asset next year in chronic dry eye.
Speaker Change: I'll now provide an update on the existing licensing program with Arctic Vision, which covers all three of our products, Micropine, Aperture, and the Combi in China and South Korea. This licensing program provides for sales royalties in addition to development milestones.
Speaker Change: If our products are approved upon commercialization, we'd also be eligible to earn significant sales royalties.
Speaker Change: We are excited about the improvements the OptiJet may provide for patients required to deliver topical ophthalmic medications and believe this platform has widespread utility.
Speaker Change: Similar to Formosa, Senju, and STN, we are seeking opportunities which can leverage the OptiJet technology in additional large ophthalmic indications such as glaucoma.
Speaker Change: I'd now like to turn the call over to our new Chief Financial Officer, Andy Jones. Andy? Thanks, Brad. I'm very excited to be here with everyone today as part of the I Know Via team.
Andy Jones: For the third quarter of 2024, we reported a net loss of approximately $7.9 million or 11 cents per share on approximately 69.5 million weighted average shares outstanding.
Andy Jones: This compares to a net loss of $7.3 million, or $0.18 per share, and approximately 40.1 million weighted average shares outstanding for the third quarter of 2023.
Andy Jones: Gross loss for the third quarter was 131,000, which compares to 12,000 for the prior year quarter.
Andy Jones: The losses are primarily the result of adjustments to write down inventory to net realizable value during the respective periods related to mid-combi in our Gen 1 device.
Andy Jones: Total operating expenses for the third quarter of 2024 were approximately $7.2 million as compared to $6.5 million for the same period in 2023.
Andy Jones: This represents an increase of approximately 10.6%. Our third quarter 2024 operating expense figure also included approximately 1.2 million of non-cash expenses.
Andy Jones: We continue to evaluate capital raising structures to fund our ongoing strategy and to make near-term payments on our Avenue Loan. Also, as always, we continue to look at ways to improve our operating efficiencies and control expenses.
Andy Jones: We are excited about our commercial portfolio, our development pipeline, and our current and future partnerships that leverage the OptiJet platform.
Andy Jones: We believe that we have established a foundation for growth as a leading ophthalmic company with a novel and highly differentiated technology and applications across several very large market ophthalmic indications.
Andy Jones: To summarize our key highlights today, first, we are preparing for an analysis of the three-year efficacy data from our ongoing Phase III chaperone trial of micropline in pediatric progressive myopia this quarter.
Andy Jones: If positive, this data may allow us to significantly advance our remaining development timeline.
Andy Jones: Also, we commence the manufacture of registration batches of MidCombi and our state-of-the-art Gen 2 OptiJet device.
Andy Jones: We also announced the U.S. launch and commercial availability of Clobetasol, which is the first new ocular steroid approved in more than 15 years.
Andy Jones: Customer feedback has been very positive and we are very excited about the opportunity here.
Andy Jones: With over 6 million surgeries performed each year in the U.S. for which patients could potentially benefit from clobetazole, we believe that even a low single-digit market share would be very meaningful for us.
Andy Jones: We entered into development collaborations with Formosa, Senju, and SGN to develop novel therapeutic formulations for the OptiJet that would potentially address unmet needs in acute and chronic dry eye disease.
Andy Jones: And finally, our licensing agreement with Arctic Vision is progressing well and remains a promising avenue for significant development and regulatory milestones, as well as the potential for sales royalties.
Andy Jones: This concludes our prepared remarks. We would now like to open the call to questions. Operator?
Speaker Change: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue.
Speaker Change: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
One moment, please, while we poll for questions.
Speaker Change: The first question is from Matthew Caulfield from HCA Wainwright. Please go ahead.
Matthew Caulfield: Hi, thank you. Hi, Michael and team, and thanks for the update.
Matthew Caulfield: Obviously, we're looking at the myopia progression of less than 0.5 diopters, but are there other top points that are most clinically meaningful or relevant as we get closer to that readout?
Speaker Change: Thank you, Matt, and it's a very good question. So the way this is going to work is that the Independent Review Committee, which is truly independent of us and is made up of expert medical doctors and optometrists in the field,
Speaker Change: and dive into the data which will take a few days more to see exactly what's going on. Things that we will be looking for obviously is the efficacy endpoint that you talked about which is the number of or portion of patients that do not progress more than half a diopter after three years of therapy.
Speaker Change: But in addition to that, the things I would like to look at are the things that make the OptiJIT very special.
Speaker Change: and those would be things like the side effect profile, where we anticipate because we're in the ophthalmic spray that we should be more comfortable than would be expected from an eyedrop.
Speaker Change: or things later on about compliance, where we would want to see that the children in the study
Speaker Change: were able to comply with therapy more than what you have seen in historical studies that are similar.
Speaker Change: evaluation as well and we'd like to see that there's very little
exposure systemically to atropine.
Speaker Change: during the study too, which could be another advantage. So those are the types of things that differentiate the OptiJet delivered product versus perhaps an eyedrop that we'd wanna look at.
Speaker Change: Very helpful. And then do you mind if I ask this one quick follow up on chaperone as well?
Sure.
Speaker Change: So with that trial dosing as young as six years old, which you mentioned, is there a sense of what age range progressive myopia is most commonly identified in practice? Like presumably children are identified a little bit earlier than that. Is that accurate or?
Speaker Change: Right, so there's actually a number of publications in the area and one of the things that we've been told is that the way that these children are identified is you have a child come in usually when they're in kindergarten when they first get their eyes examined.
Speaker Change: So they're five years old, six years old, they come in, they're myopic. The doctor looks around, both parents are myopic. That's usually a very good signal that there's probably a genetic component and they're at the most risk.
Speaker Change: and you want to capture them when they're 5, 6, 7, 8 years old, because the progression of myopia is tied to development of the eye.
Awesome. That's very helpful guys. I appreciate it. Thank you.
Unknown Speaker. Okay.
Speaker Change: The next question is from Matt Kaplan from Ladenburg-Gelman. Please go ahead.
Matt Kaplan: Hey guys, thanks for taking the questions. Just to follow up on the chaperone interim analysis, what's the potential powering that you'll have with this interim analysis as you go into it?
Speaker Change: Thanks Matt and always good to hear from you as well. I wish I had the statistician here. I believe the power calculation was something around 85%.
Speaker Change: with what we have and that's at a p-value of less than 0.21. If I'm off by a little bit, please don't hold me to that because I'm trying to remember what was in the statistical plan. But it's adequately powered at this point and that's why we're having the independent review committee take a look at the data.
Speaker Change: And in terms of how that works in terms of the independent review committee gives you an answer and then you do the full analysis is that is that the way it works and and when right exactly.
Speaker Change: So they see it, and then they say yes or no, there's something here. If there is something here, then Inovia makes the decision to go ahead and open the database at that point, and then we would do the full analysis, and that will take several days to see exactly what's in there.
Okay.
Speaker Change: Right, and if this is positive and you do the analysis, what would be the timeline to a potential NDA filing in this indication and what would be the rate limiting step?
Right, so if the analysis is positive,
Speaker Change: I'm not really sure that there would be anything because if we have a positive study, what the FDA would be looking for is efficacy and how does that compare?
Speaker Change: the safety and in the mask data which we've been looking at, we have a great safety profile. There's been no significant adverse events that are treatment related than the AEs we do see are the ones that you would expect from this kind of therapy and they've all been mild and very short lived.
Speaker Change: and are you able to leverage the existing atropine safety data to facilitate the NDA filing?
Speaker Change: Well, the FDA is allowing us to use the LAMP study and the ADAMS study in place of one phase 3 study.
Speaker Change: So, yes for that. For us, I'm sure that we'll want to reference that, but I think we'd love to have our safety data in that label because I believe, and I haven't seen the data yet, that our safety profile may be superior to what you would get with an eye drop just simply because we have the lower dose volume.
Great, thank you for the added detail.
Thank you, Matt.
[inaudible]
Speaker Change: The next question is from Lachlan Hanbury Brown from William Blair. Please go ahead
Speaker Change: Hey guys, thanks for the question. I guess first, can you just help us understand the revenue number in the quarter? I mean it looks like it was down over Q2, but you did report an increase in the number of centers or practices using MidCombi, so can you just explain the dynamics there?
Speaker Change: Yeah, so we're super excited about MidCombi. We have it in over 200 offices with a good response from those folks. Our next goal is to continue to push that out to additional offices with the goal of...
of having 200 more.
So, you know, the revenue number in Q3.
Speaker Change: is about $2,000. We think we could go for about up from there.
Speaker Change: But I think that revenue number also reflects that, you know, we were preparing for the launch of Clobetasol, and we feel like having both of those products out there with our sales team will benefit both channels in the current and future quarters. Right. Let me add to that also, and thank you, Andy, that
Speaker Change: like any pharmaceutical product, when you go and you launch it, the first thing you're going to do is you're going to bring samples into the marketplace because people are going to want to try.
Speaker Change: your new product. In this case, we're bringing a brand new technology that people need to be exposed to, they need some training, and they need to use it actually on patients.
Speaker Change: Unknown Executive, Bren Kern, John Gandolfo, Michael Rowe, Michael Rowe, John Gandolfo,
Speaker Change: and do the same sort of thing. And then lastly, when Andy had said about helping to leverage clobetazole, it does do that because we can bring both of the products and they solve two different issues for the same thing. Pre-surgical, you have MidCombi and then post-surgical, you have clobetazole. So it's a nice way to round out that sales call.
Speaker Change: Thanks. And on, um, on clobetazole, you know, it sounds like you, you're seeing good interest. Can you maybe just talk a bit more about what you're seeing sort of in the field? I think you said.
Speaker Change: You were in 100 pharmacies for officers. Is there anything you can provide on sort of how many doctors have used it or anything along those lines at this point?
Speaker Change: I don't have those figures, but what I can tell you is what we're finding is that the doctors are very attracted to the profile and very interestingly, more attracted to how we're distributing because they do have so many problems.
Speaker Change: with prior authorizations and other issues with managed care for this class of drugs. And we find that what's working very well for us
Speaker Change: is we are selling clobetazole into the mom and pop pharmacies that are usually located in the medical arts buildings and the other places near where the surgeons are. And they just very simply write the product. The patient goes downstairs, picks it up. The price is always the same regardless of their insurance status.
http://TheBusinessProfessor.com
Oh, thanks.
Thank you
Speaker Change: The next question is from Kemp Dolliver from Brookline Capital Markets. Please go ahead.
Speaker Change: Right, a couple of questions. First on MidCombie, when you mentioned 200 additional offices, did you mention a time frame for that?
Speaker Change: I didn't, but I'll share it with you now. They're going to hit those 200 offices this quarter.
Okay, fabulous.
Unknown Executive, Bren Kern, John Gandolfo, Michael Rowe
Speaker Change: Right, we don't go into a, we pre-qualify an office to have at least five lanes.
Speaker Change: So you would usually have five techs with their doctors working simultaneously. So that would be the minimum size office that we would be going into.
Speaker Change: Great, that's very helpful. And my last question is to go back to the relationship between revenue and cost of sales this quarter because in prior quarters
Speaker Change: You know, we've seen some costs that were related to buying back the
Speaker Change: Micropine inventory from Bausch & Lohman completely unrelated to MidCombie. So this quarter is this an apples-to-apples relationship or are there other expenses?
in there.
Speaker Change: So the cost to reacquire the product on our former relationship, those would be outside of cost of goods sold, so those wouldn't be included in that number.
Speaker Change: The numbers you're seeing coming through CODS are, you know, adjustments primarily for, you know, either short dated inventory or for, you know, overhead that's applied to finished goods that we have to reduce to net realizable value.
Speaker Change: So those numbers can fluctuate depending on what we have in terms of inventory and when that might expire, or in terms of how much overhead that we're applying to the product.
Speaker Change: We, you know, we anticipate as those volumes increase that number would change. I think when you're comparing, for example, the second quarter with the third quarter this year, I'd say that that those were different adjustments. I think.
Speaker Change: In the second quarter, it was more related to short-dating on some of our finished goods that we had produced early on in the commercialization and the development of that inventory.
Another thing to point out about these losses is that
Speaker Change: You know, because those have already been committed in terms of overhead or in terms of inventory purchases, but we'll continue to look at those those every quarter, but I don't, you know, I don't personally see anything alarming here. And I think that the adjustments have been a little bit different each quarter, but, but we'll continue to look at them and, you know, we'll probably continue to see some of that.
Speaker Change: But as I mentioned, as we grow other channels in this channel, we expect the magnitude of those to wane.
Great, thank you.
Thanks, Kemp.
Speaker Change: The next question is from Len Yaff from Stock Talk Partners. Please go ahead. Thank you very much. I had two questions for you, Michael. The first is you touched on this, but given with micropine, you're looking at a pediatric population,
Speaker Change: which are very sensitive to drug delivery. Could you talk about the advantages that the OptiJet will likely have versus traditional dispensing to make sure you're getting the right dose?
Speaker Change: in the patient in order to be able to have the appropriate effect. And then the second question, and you may have mentioned this and I could have missed it, was I'm trying to understand where I know that there may be, that there's scheduled to be possibly the interim look soon, but when will...
Speaker Change: the public, when will an announcement be made in terms of what those top line results are? Because I'm trying to understand the timeframe, given your current cash position, to when shareholders, potential investors would understand what the top line data are. Thank you.
http://TheBusinessProfessor.com
Thank you, Len. Let me answer the second question first.
Speaker Change: The Independent Data Review Committee, which is truly independent from us.
Speaker Change: They are meeting very, very shortly. Now, you know, getting them to meet when they're all very busy, well-recognized experts in the field, I'm sure it's not been an easy feat.
Speaker Change: for the chairman of that committee, but that should be happening.
Speaker Change: And once that does happen and we get an answer from them,
Speaker Change: Our commitment is to share that answer within a day of when we have it. But is the answer the data or is it just a yes-go, no-go?
Um...
for what I believe our product offers.
Speaker Change: that's superior to eye drops in pediatrics. There's a number of things. If anybody.
Speaker Change: to their child, they know that that's difficult to begin with just to do that, never mind the child doing it by themselves.
Speaker Change: I think the exposure is another issue. You have less systemic exposure with the OptiJet.
Unknown Executive, Bren Kern, John Gandolfo, Michael Rowe
Topical Tolerability, you know the stinging that's associated with
Unknown Executive, Bren Kern, John Gandolfo, Michael Rowe
Speaker Change: because if a child's not taking the medication, it's not going to do them any good over the long term. So there's just, those are four things I can think of off the top of my head. I'm sure there's probably others as well, and we see those as meaningful differences.
Speaker Change: Great, and then just so I understand again, the independent committee will evaluate the data, let you know, and then you'll take a couple weeks to go through the data. When would be the earliest that
Speaker Change: The public will be aware of what the top line results are. Is it soon after that or is it not for another quarter or two?
Speaker Change: No, it'll be it won't be another quarter or two, it'll be, I would say, you know, within a quarter within the same quarter. Excellent. Thank you so very much.
http://TheBusinessProfessor.com
Thank you.
Speaker Change: The next question is from Kent Oliver from Brookline Capital Markets. Please go ahead.
Kevin, you're back. Thanks. I wanted... Yeah.
Speaker Change: I just want to clarify the timetable based on a couple of your comments because earlier on you made reference to your review taking several days and then you said just now that
Speaker Change: It'll take several weeks. I don't know if we're, if those refer to the same steps in the process. I just want to be clear that I understand the timetable you laid out.
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Speaker Change: I'm sorry, so I'm not sure exactly when we're going to get the information from the data review committee. When we do have that, we will share that.
Speaker Change: very quickly, and then we will take the time, and I don't know if the time is going to be a week or it's going to be four weeks to go through that data, but as soon as that analysis is done, that's when we will share it, but prior to that even happening, when that DRC recommendation is communicated to us, we will share that, and that in itself is a pretty meaningful event.
Speaker Change: Okay, great. So it's essentially going to be potentially two disclosures.
Yes, I would say that is correct.
Okay, thanks. That's very helpful to know.
Thank you, Cam.
Speaker Change: This concludes the question and answer session. I would like to turn the floor back over to Michael Rowe for closing comments.
Michael Rowe: Thank you, Operator, and thanks to everyone on the call today for taking the time to join us.
Michael Rowe: You know, this is an exciting time to be with Inovia as we prepare for several transformative events all occurring in the next few months.
Michael Rowe: Many of those events will be discussed at an upcoming R&D webinar scheduled for Wednesday, December 11th at 1 p.m. Eastern Time. The webinar will feature three leading and well-published doctors who will cover the unmet medical and other opportunities that are and can be addressed by our products, Midcombe, Clovetazol, and Micropine.
Michael Rowe: More information about this event will be coming out just before Thanksgiving, both through a press release and on our website, inovia.com. We invite all of you to register for what we anticipate will be a very informative session. Thank you again, this concludes our call and we look forward to talking with you again very soon.
Michael Rowe: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.