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Healthcare - Biotechnology - NASDAQ - US
$ 0.1019
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$ 29.4 M
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EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2018 - Q2
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Executives

Tram Bui - Investor Relations, The Ruth Group Sean Ianchulev - Chief Executive Officer and Chief Medical Officer John Gandolfo - Chief Financial Officer.

Analysts

Scott Henry - ROTH Capital.

Operator

Good day ladies and gentlemen and welcome to the Eyenovia Second Quarter 2018 Earnings Conference Call. At this time all participants are in a listen-only mode. Later, we’ll conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this call is being recorded.

I will now like to introduce your host for today’s conference, Miss Tram Bui. Ma’am you may begin..

Tram Bui

Good morning and welcome to Eyenovia’s second quarter 2018 earnings conference call and audio webcast. With me today are Dr. Sean Ianchulev, Eyenovia’s Chief Executive Officer and Chief Medical Officer and John Gandolfo, Eyenovia’s Chief Financial Officer.

Earlier this morning, Eyenovia issued a press release announcing financial results for the three months ended June 30, 2018. We encourage everyone to read today’s press release as well as Eyenovia’s quarterly report on Form 10-Q which will be filed with the SEC later today.

The company’s quarterly report and press release will also be available on Eyenovia’s website at www.eyenoviabio.com. In addition, this conference call is being webcast at the company’s website and will be archived there for future reference.

Please note that certain information discussed on the call today is covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act. We caution listeners that during this call, Eyenovia’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 is subject to a number of risk including risk related to fluctuations in our financial results, risks to our clinical trials, included by not limited to the initiation, timing, progress and results of this trial.

The timing and our ability to submit applications for obtain and maintain regulatory approvals for our product candidates.

Our estimates regarding the potential market opportunity, product candidates, our ability to attract and maintain key personnel and other details -- qualified by the cautionary statements contained in Eyenovia’s press releases 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 August 14, 2018.

Eyenovia 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 maybe required by requisite applicable securities law. With that, I’d like now to turn the call over to Sean..

Sean Ianchulev

Thank you, Tram and welcome everyone to Eyenovia’s second quarter 2018 earnings conference call.

In the first half of 2018, we continue to progress with the development of our extensive late-stage pipeline, in addition to further validating our novel therapeutic platform for -- with compelling results from our PG21 study and the notice of grant of additional patterns in the U.S.

As we prepare investigation on new drug applications to initiate Phase 3 development for our programs, we have decided to accelerate our MicroPine problem to address the significant medical unmet need and potential market opportunity of progressive myopia.

We look forward to submitting two INDs this year and anticipate initiating all three Phase 3 programs throughout late 2018 and 2019. And with the over-the-counter registration of MicroTears for dry eye on the horizon, we are beginning to develop commercial and marketing strategies with the hire of Michael Rowe as our VP of Marketing.

Michael will play a critical role in advancing our position as an innovator, focusing on the possibilities that microdosing brings to the field of ophthalmology.

For the past one hundred years, almost all topical treatments to the eye, from glaucoma to dry eye, have been delivered using the legacy eye dropper technology, and with this technology delivering of medication is highly variable.

In a compelling study highlighted in JAMA ophthalmology, researchers used video recording to evaluate patient performance of eye drop installation.

The study found that only one third of patients were able to successfully deliver medication through eye base on three key performance criteria; successful installation into the eye, installation of only a single drop in not touching of the bottle to the eye.

Other studies have also identified that patient deliver a mean of 2.6 drops to the eye and such the bottle keeps to their eye in approximately 50% of installations.

These results run against patient’s perception of their own success, when up [ph] more than 60% of patients believe that they never meet their eye drops and 90% report no problems putting in their eye drops.

In reality though, patients truly don’t realize that they aren’t getting the prescribed dose or missing their eye entirely when installing high drops, potentially leading to ineffective treatments or overdosing which may lead to topical and systemic side effects.

Recently, we completed the full knowledge [ph] of the PG21 study investigating the medication administration effectiveness and IOP lowering effect of microdose latanoprost 0.005% in 60 eyes of 30 healthy volunteers.

In the study, participants received once daily microdose treatment over 2 consecutive days and underwent diurnal IOP intraocular pressure assessment four times a day. The primary outcome we examined was success of microdose delivery, with additional outcomes evaluating diurnal intraocular pressure change each day.

In the study, after a brief medication administration training session, investigators successfully administered high-precision piezo-print microdose latanoprost with a single spray 95% of the time. A separate evaluation of patient self-administration showed an 88% success rate following limited training.

This is a dramatic leap inefficacy and accuracy of delivery, and almost double what is seen with conventional eyedropper technology.

In addition, each single medication administration was within 1 micro liter of the prescribed dose and the tear capacity of the eye, while eye dropper administration typically delivers as much as 300% more with high variability of dosing.

Our PG21 study also affects the topical ocular delivery of highly precise microdose, which matched the physiologic tear film capacity of the eye in single digit micro liter volumes reducing exposure of toxic preservatives and medications to the eye by more than 75%.

We believe this is extremely important for patients with glaucoma, dry eye and myopia who might need chronic therapy for ears and suffered the side effects of dose therapies.

Needless to say, we are extremely happy that Eyenovia may be on the threshold of introducing a new paradigm of high precision, high efficacy topical delivery for front and back of the eye therapies where patients and doctors maybe assured the prescribed dose is delivered to the eye accurately and consistently.

We believe this will further reduce wave of improved safety and potentially lead to better care in the field of ophthalmology.

Furthermore, as we reported previously the study also demonstrated that, while reducing drug administration volume by 75% by delivering the microdose accurately and directly on the corneal surface, piezo-print micro-formulated latanoprost achieved a very robust reduction in diurnal intro ocular pressure of upto 29% from baseline unmedicated intro ocular pressure.

This is consistent with the reported reduction of up to 26% achieved with the same concentration of standard latanoprost eye drops. We find these results very encouraging as you will recall we reported similar confirmatory results from our two earlier Phase II trials in mydriasis, which have already been published.

In addition to the PG21 study, we also recently noted – we received two notices of allowance from the United States patent and trade mark office granting us two patents which provide us with fundamental coverage on physiologic microdroplet ejection diameters and velocities, which enabled the gentle delivery of ophthalmic therapeutics to the eyes at velocities that beat the eye blinks reflex.

This patents are key to delivering how our micro formulations and expand our IP portfolio to a total of eight in the U.S. Furthermore, we currently have seven pending patents in the U.S. and 54 pending patents worldwide.

Turning now to our clinical product programs, starting with MicroPine [ph] for the treatment of progressive myopia, which is becoming an increasingly important part of our pipeline.

Progressive myopia is the back of the eye disease characterized by increased axial length and progressive elongation of the eye, causing increased refractive error in nearsightedness. In the U.S. alone, there is a estimated 5 million children with significant myopia, with that number rising sharply to nearly 80% to 90% of young adults in Asia.

Without an FDA approved therapy to slow progression, we expect to see an increase in the rates of visual impairment by 7 to 13 fall by 2055.

We believe this creates a significant market for a therapy designed to slow progression with an estimated treatable population greater than that of the total addressable population for open angle glaucoma and wet macular degeneration combined.

Recently, academic institutions have conducted two major collaborative studies examining the therapeutic activity of topical atropine, which is an anticholinergic agent used for dilation. This studies which were large five year randomly controlled trial demonstrated that atropine can slow myopia progression by upto 60%.

Despite these studies though, there remains no FDA approved treatment for myopia progression to our knowledge. We think this is because current formulations of atropine have an unacceptable safety profile with significant side effects as well as a very short shelf life.

However, these studies indicate that low dose atropine offers acceptable efficacy with better tolerability and safety profile, laying the groundwork and significantly reducing the risk of using low dose atropine.

With that said we are very excited to accelerate our MicroPine program for [Indiscernible] desubmission and will prioritize the Phase III trial to start in the first half of 2019.

Using our microdose approach, we can deliver precisely 6 to 7 micro liters of atropine to the eye in order to potentially obtain the desired therapeutic effect and eliminate 75% of formulation load and exposure. MicroPine is also stable formulation with a two year shelf life.

Furthermore, as we had previously mentioned, after discussion with the FDA, the agency has indicated that potentially only one Phase III pivotal study will be required for MicroPine which will reduce the cost and timeline we need to invest to reach the potential NDA submission.

Finally, as we prepare for the over-the-counter registration of our dry eye product MicroTears in 2019, we have begun developing, marketing and commercial strategies and we’re excited to bring on board Michael Rowe as our VP of Marketing.

Michael is a veteran of marketing professional and has more than 20 years of experience commercializing products in the U.S. and globally. He has particular expertise in the ophthalmology space having joined us from Aerie Pharmaceuticals, where he was responsible for the U.S. and international commercialization, planning and execution of Rhopressa.

He also spend 12 years at Allergan, where he supported the strategic planning for the company’s worldwide glaucoma franchise. Mike will help lead the charge as we plan to introduce our revolutionary technology to ophthalmologists, optometrists and patients, starting first with MicroTears into the Eyecare practitioner’s office.

We feel confident that Michael's commercial ophthalmology experience will be an will be an invaluable asset in planning our strategic direction as we near commercialization. And now I would like to turn the call over to John to discuss our financial results..

John Gandolfo Secretary

Thank you, Sean and once again thank you all for joining us this morning. Second quarter of 2018, we reported a net loss of approximately $3.3 million or $0.33 per share compared to a net loss of approximately $1 million or $0.43 per share for the second quarter of 2017.

Research and development expenses totaled approximately $2.4 million for the second quarter of 2018 and this compares to approximately $800,000 for the same period in 2017 an increase of 221%.

The increase is primarily due to an increase in contracted services, supplies and personnel as we continue to expand our R&D activities for our microdose products. For the second quarter of 2018, general and administrative expenses were approximately $900,000 compared to approximately $200,000 for the second quarter of 2017, an increase of 304%.

This increase was largely due to increased headcount associated with the growth of our business as well as cost related to being a public company. Total operating expenses for the second quarter of 2018 were approximately $3.3 million compared to total operating expenses of approximately $1 million for the same period of 2017, an increase of 240%.

As of June 30, 2018, the company's cash balance was approximately $24.6 million and we believe we have sufficient cash balances to the end of 2019 allowing us to progress our pipeline of programs towards Phase III development and OTC registration. That concludes our financial remarks.

I would like to hand the call back over the Sean for closing remarks..

Sean Ianchulev

Thank you, John and let me conclude by noting that we are extremely pleased with our accomplishments in the second quarter, including our successful PG21 study which we believe further validates our novel technology and the noted [ph] to grant two additional patents in the U.S.

While we are prepared to submit two IND applications by the end of this year, we are on schedule to initiate our first Phase III clinical study with MicroStat for mydriasis before the end of the year.

As we seek to rapidly develop our marketing and commercialization strategy with the over-the-counter registration of MicroTears, we look forward to working with Michael Rowe as we near potential commercialization. That concludes our prepared remarks, and we’d like to open now the call to questions.

Operator?.

Operator

[Operator Instructions] Our first question comes from Scott Henry with ROTH Capital. Your line is now open..

Scott Henry

Thank you, and good morning. And I was juggling multiple calls so I apologize if you hit on any of these questions during your prepared remarks.

First of all on MicroPine, clearly a significant focus through the company, could you talk about what Phase trial, Phase 3 trial would look like in terms of endpoints and timeline?.

Sean Ianchulev

Yes, Scott good to have you on, this is Sean here wanting to address your questions. Yes, MicroPine is becoming a lot more center and front for us as we realize how big of an unmet need that is.

I mean, we are talking dramatic difference in population compared to some of our other programs and in the field of ophthalmology, in fact myopia seems to be just as big as therapeutic areas [ph] and opportunity as most of the other back of the eye conditions.

And also one of the things we realize as we dive into these further is that, MicroPine and myopia progression used for this indication.

In fact, myopia progression is a back of the eye disease as we highlighted earlier, and this maybe the first one of the very few times we are treating a back of the eye disease and we have a front of the eye approach for that, because as you know we treat macular degeneration and Diabetic Macular Edema with anti-VEGF, but those actually require intravitreal in the eye injections.

And here what some of the collaborative studies have highlighted and shown us with a lot of data and is very rare that we get the benefit to design our Phase III programs when most of the really is a major randomized controlled studies have already been done and we can benefit from looking at the wealth of that information.

So we're very excited about this, we are looking at ways to accelerate this dramatically and the Phase III program where we’re looking at is basically a randomized control study with two concentration of the microdose atropine that we have, which will be own formulations where we are doing and pursuing pretty much all of our programs with our own formulation.

And that control arm will be sham [ph] placebo microdose without the therapeutic agent.

And the endpoints for that are really very logical and they're very similar to what was shown in the collaborative, that is, it’s basically the change in the refractive error overtime, and it will be with a three year end point because as we know this really impacts a lot of patients and it's a chronic condition when young adults in the ages between 5 and 17 are taking that drop.

If you're five years old, and you start out at a refractive error of minus one or two, by the time you're eight some of those patients go to minus five, the optics of refractive error and some of them can reach as much as minus 10, minus 15 which is very unhealthy, because it’s associated with maculopathy, with retinal detachment, it’s a big problem.

And again, that is a therapy that we anticipate people will need for many many years until the eye reaches about 20 years of age when it stops elongating and stops developing.

So the end points reflect that, their logical endpoints, about three year endpoints, but in fact we've seen already, five-year data with low dose atropine by the collaborative studies, which show a dramatic effect of almost 60% and more interestingly its replicating a number of trials.

So again, we are pursuing a very similar end point that we are pursuing very similar trial design which is being informed by all these collaborative studies but we are pursuing it in a regulated give it away for an FDA registration of that program..

Scott Henry

Okay.

And if I could just ask one follow-up question, it would be how fast do you think this trial would enroll? And will there be any opportunities for interim data between time zero and three years out?.

Sean Ianchulev

Again, its very good question, Scott. I think that it's not going to be a huge trial. We anticipate – again, I wouldn't say we've completely locked down the numbers yet, but we anticipate this would be about 600 patients study. And again as you look at -- this is not compared to other back-of-the-eye diseases. This is not an intravitreal injection.

We're not going to inject the eyes of young adult with the therapy here. It's just a simple microdose spray. And we have a tremendously rich population opportunity here about 5 million in the U.S. addressable population and much more. If you go to Asian countries, I think for this one we don't even need to worry about outside the U.S. to source patients.

So I think my – as a person who have spend a lot of time in ophthalmic development, we headed out the incentives programs back in the days for Genitech.

I think this is a material different patient population and enrollment strategy and our VP of Clinical Operation, Ginger Clasby, I think we're pretty confident that we will be able to achieve fast-paced enrollment. In this case what I would consider a fast-paced enrollment would be less than 12 months to the program fully enrolled.

In terms of interim analysis, I don't want to commit to anything right now, because we're still in the process of completing our statistical analysis plan. But I would say one thing, Scott, interim analysis sometimes are informative.

When you have – when you go into the standard development path from the Phase I to a Phase II, to a Phase III and you have a new molecular entity, for example, that there is a very little information.

I think here we have a situation where we have already preceding and anticeding data, which is highly informative of not three but five-year outcomes of low dose atropin in multiple randomized controlled studies. So we're evaluating the need for an interim.

I know from an investment standpoint, some investors like to see a little peek at the data, but we also want to make sure that we maintain the most – the highest level of integrity for the trial and also we are marching towards the final end here.

Because it's very rare that in fact one can have an opportunity to launch a Phase III program in such big indication with such a dramatically enrich population and we already have a fairly good idea from the collaborative studies of what to expect.

Now, it can always differ eventually, but it's nice to see that we have not one, not two, actually there are multiple studies out there in myopia progression that have service over the last two, three years and that's really formative for our Phase III development. .

Scott Henry

Okay, great.

If I could just sneak in a very quick question, I noticed G&A was down a little bit from the first quarter? The question is what you think is more representative of the current G&A rate? What we saw in the first quarter or what we saw in the second quarter?.

John Gandolfo Secretary

I think its probably going be about where we in the first quarter. I know it was down slightly in the second quarter, but as Sean mentioned we've recently hired Michael and we have some other increased costs that are expected.

So I expect that to be a lot closure to what was in the first quarter going forward?.

Scott Henry

Okay, great. And thank for taking the questions..

John Gandolfo Secretary

Thank you, Scott. Always a pleasure..

Operator

Our next question comes from Matt Kaplan with Ladenburg. Your line is now open..

Unidentified Analyst

Good morning. Thank you for taking the question. This is Maria for Matt. My first question is PG21 study.

The primary outcome was success for microdose deliver and just maybe a trivial question, but what's defined as -- obviously the delivery of the drug but who determines that the patient or physician?.

Sean Ianchulev

Yes. Let me address that. That's really – I think it’s a basic question and it’s a good one, because how we know when a patient actually gets the correct dose. And as we demonstrated and I think part of our script also focus on multiple studies that have shown that patient perception is very poor when it comes to eye drops.

I mean, most patients think they got and it turns out that only half of them or less than half of them actually got the correct dose. And we have seen multiple studies; we have looked at that with videography and video assignment and third party assessment. In our study, we have the benefit of both conformations.

The first that the microdose is very fast and its micro-droplet that's delivered to the eye, but because the eye is very sensitive, the patient can register the delivery of the dose of the microdose with the eye, not like they're not aware when the eye gets the micro-droplet, because the cornea has -- its one of the areas in the body where it has the most receptors and nerve ending to detect any exposure.

In our study we relayed on the patient and on the third-party observer confirmation that the microdose was delivered to the eye. And that's why we have very instance or two as you see with the numbers of 95% in the third-party administration and the 88% in the self-administration.

We had a few patients that needed a second try at this, but again even at that we are seeing a real leap in technology here and efficacy of delivery compared to the eye drop of paradigm..

Unidentified Analyst

Okay.

So then, the study also its says that participants receive once daily microdose treatment over two consecutive days with one eye treated first day and then the second eye the second day?.

Sean Ianchulev

No.

It was basically both eyes were treated at the same time on both day, so they receive one dose and then we measured which is typical in the glaucoma studies, we measured the intraocular pressure throughout the course of the day, because that's how evaluate what we called the diurnal intraocular pressure and the diurnal intraocular pressure is measured at three times point during the day and then average which is the standard paradigm in glaucoma studies.

So they receive the one dose micro formulated latanoprost on day one and another one on day two. And we're preparing now the formal presentation and publication of the results with all the details of the study..

Unidentified Analyst

Okay.

So their plan is still to present this data on a coming medical conference and to publish the results?.

Sean Ianchulev

Right, absolutely. Yes. We're planning to publish the result just like we did with our first two studies that were published in mydriasis.

And again we were very comfortable with what we learned from mydriasis, which is the pupil dilation study because pupil dilation study is really the end point there is dilating the dilation of pupil to pharmacologic exposure and it’s a very sensitive and specific biomarker or pharmacodynamic marker.

And again for us showing the same effect of the microdose latanoprost in terms of another pharmacodynamic such as intraocular pressure is really validating across the entire spectrum of front-of-the-eye treatment that you don't need a over dose or imprecisely dose or immaculately dose eyedropper delivery, but you can achieve similar efficacy with a high precision microdose which reduces the total exposure to drug and preservative by more than 75% and has some safety benefits along the way..

Unidentified Analyst

And then my last question is about MicroPine, obviously a large market opportunity especially in Asia. So I think design of license and development agreement with Senju 20165 where they have their have their rights to developing commercialized products in Japan and the rest of Asia.

So could you elaborate on that partnership? Are they working on the same indication not only the MicroPine but also the other program and where do they stand in terms of development?.

Sean Ianchulev

Yes. That's great. And it’s a good point to bring out a little bit, because when it comes to MicroPine, the opportunities really big in the U.S. and Europe and this is the market that belong to Eyenovia, but -- and we're seeing here in general that population in U.S. and Europe, the rates of myopia are about 40% or so.

In Asia we're seeing 80% to 90% and there is a lot of population studies have looked at that. So the opportunity is even dramatically bigger in Asia and we are working very closely with our partner Senju and Senju is a founding investor in Eyenovia, one of our largest shareholders.

And also its highly interested to a developed OUS, the Asia opportunities. In fact one of the things that we've charged Michael Rowe who came on board is really to work very closely with Senju in defining the Asian opportunity and stealing our approach there.

As you know, Asia is a big place with a lot of different countries that will have for sure different regulatory approaches and development approaches. So, we hope to have a lot more on that, but for us and in terms of the biggest impact to Eyenovia right now where we are in-charge of our own development and market opportunity, that's for us is U.S.

and Europe and here it’s a huge market because it’s a back-of-the-eye disease one of the very few back-of-the-eye disease is that we can treat with the tropical treatment and at the same time it’s a market opportunity as we mentioned that bigger in terms of addressable population, bigger than all of glaucoma and wet macular degeneration combined.

So there's a lot for us to do and that's why we are motivated to accelerate our development here and in parallel we are also pushing the envelope forward in Asia with Senju, and hopefully very soon in the coming calls we'll have more to update you in that respect..

Unidentified Analyst

Okay. Thank you for taking the questions..

Sean Ianchulev

Always a pleasure..

Operator

[Operator Instructions] Our next question comes from [Indiscernible]. Your line is now open..

Unidentified Analyst

Hi. Sean. Thank you for taking the questions. This Kartik on for Yee [ph].

So I wanted to understand that how many more patients would be enrolled in each Phase III trial and when exactly will MicroPine and MicroProst Phase III trial you reported?.

Sean Ianchulev

Okay. So in the Phase III trials from MicroProst, as we've said before we're conducting two Phase III programs in MicroProst in chronic-angle closure glaucoma, again an indication where we don't have anything that's currently approved. And those would be about 250 patients per trial that we conservatively estimated. We're going to file the IND.

We're hoping to file the IND as we've said before for MicroStat and MicroProst this year and MicroPine next year. And again, for MicroProst the trial we hope to enroll, the estimates are about 12 months or so and then from there on the primary end point is three months.

So again MicroProst is a fairly fast-paced program in terms of endpoints because they're only three months endpoint, and again six months follow-up, total follow-up for the patient. And from there on we're going to file the NDAs.

For MicroPine, again we're hoping to initiate and we've said before we're going to initiate the study in the first half of 2019. My team is working on prioritizing and potentially accelerating that further. And if we're planning about the 12 month enrollment then you tack [ph] to about three year follow-up of that – of those patients.

And you're going to find that we'll be looking afterwards to file the NDA within a few months.

So the MicroPine is a little bit further out and that's what we like our portfolio and pipeline, because we have the big crown jewel of a big opportunity which is biotech type of economics here without the kind of binary new molecular entity risk is MicroPine and we're initiating that Phase III, but in the meantime while MicroPine is going forward with this longer endpoint we have the more near term programs [ph] coming in with MicroProst and even more near term with MicroStat and MicroTears which we hope to produce results of the Phase III for MicroStat.

We hope to have those results in Q1 of 2019 and what's really good about it is that with results in 2019 in the first half of 2019 maybe the first quarter of 2019 for MicroStat that really validates the whole technology platform in the Phase III program and there is nothing different about our technology and microdroplet delivery from MicroProst to any of the other indication.

So from there on everybody can connect the dots, but at the same time MicroStat will do that. We're then looking at the first half of 2019 having MicroTears which doesn't require Phase III studies or any clinical studies. It’s a artificial tier over the counter. We hope to have that ready by the middle of 2019.

So, we have a lot of work in and the team is really busy right now because their near term opportunities which are immediate and also ground breaking, because we currently we can really transform the way pharmacologic dilation is done in the office and we can really transform how people receive a dry eye treatment without official tears and we know that about $2.5 billion market currently that all use this fairly generic standard conventional artificial tears.

And then follow-on to more the later programs with MicroProst and then MicroPine. So it’s a really nice cadence of milestones and nice cadence of opportunities and unlocking the commercial potential of that technology..

Unidentified Analyst

Awesome.

And how much do you estimate that each trial will cost?.

John Gandolfo Secretary

I don't think that we broken down a per trial basis. When we look at it basically our cash burn in the second quarter was roughly $3 million.

As we start getting involved in these Phase III trials we expected to increase on a quarterly basis to roughly $4 million or $4 million plus on average at the end of 2019, but we haven't broken down the total cost per each trial publicly..

Unidentified Analyst

Okay. No problem.

And what was the side effect observed in Eyenovia's PG1 study compared to conventional eyedrops?.

Sean Ianchulev

Yes. So there was an acute study where we looked at the two-day effect. So in the context of that I mean nothing surprising. We actually didn't any average events reported. The technology was very well tolerated which is exactly what we saw in our earlier Phase II studies in mydriasis.

The goal here was more to evaluate the Phase III device going forward before we put into the Phase III studies and also to confirm self-administration, efficacy and high precision delivery and we're very happy with delivery efficacy, I mean, we're little bit surprise that and actually how well it did because as you look at eyedropper as we mentioned studies have shown that less than half of the time patients delivered adults precisely and if you look at some other studies the efficacy drops off even below 30%.

So to see something in the 80% to 90% plus efficacy we are very excited about this and we think that it’s really a paradigm shift and frankly its about time, we have smarter technology to deliver therapeutics to the eyes and what we've been having for the last 100 years..

Unidentified Analyst

Right.

And lastly how much cost of savings can microdose product achieve? And part of the savings you transfer to patients or end users?.

Sean Ianchulev

Yes. Again, we're focusing on – I mean, with our programs here, we're focusing on delivering superior therapeutic and we're focusing on improving the health economic equation more than just total dose delivered.

Because right now you can deliver – patients are delivering two to three drops and they're running out of their drops half way through the month periods and they're not getting the efficacy. So in fact there is a lot of waste that's happening and a lot of effectiveness that is missed.

And in fact we see now our studies in ophthalmology's efficacy, but we all know that the effectiveness in the real world where patients are just getting the drops and not getting the same training as in the clinical studies and they are not getting the same monitoring, the real drop, the real world effectiveness is very different.

So I think that the way our team is looking at that and actually with Michael coming on board we're going to look at that even in a more sophisticated way. He's not just looking at a volume metric reduction of medication.

We're looking at all the benefits that come with microdose and that means unlocking new indication, going into where we haven't been before such as chronic-angle closure, such as myopia where we can achieve things that we couldn't achieve of what's possible.

Then also we're looking at reducing the side effect of drug to the eye which we know dramatically important when it comes to compliance. So that has an economic factor to us and to our society and our patients and physicians, so there is a lot more to the health economics argument here than a pure volumetric medication dispensation..

Unidentified Analyst

All right. Thank you so much. Well done, Sean and best of luck moving forward..

Sean Ianchulev

Thank you..

Operator

This time I'm showing no further questions. Ladies and gentlemen thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone have a great day..

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