Eyenovia Inc (EYEN) 2018 Q4 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Eyenovia Fourth Quarter and Full Year 2018 Earnings Conference Call.

(Operator Instructions) As a reminder, this conference call is being recorded.

I would now like to introduce your host for today's conference, Tram Bui, from The Ruth Group.

You may begin.

Good morning, and welcome to Eyenovia's Fourth Quarter and Full Year 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 3 months and full year ended December 31, 2018.

We encourage everyone to read today's press release as well as Eyenovia's annual report on Form 10-K, which we will file with the SEC in the next few days.

The company's annual report and press release will also be available on Eyenovia's website at eyenovia.com.

In addition, this conference call is being webcast through the company's website and will be archived there for future reference.

Please note that 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 are subject to risks -- to a number of risks, including risks related to fluctuations in our financial results; risks of our clinical trials, including, but not limited to, the design, initiation, timing, progress and results of such trials; the timing and our need and ability to submit applications for, and obtain and maintain regulatory approvals for, our product candidates, and to raise money, including in light of any government -- U.S. government shutdowns; our estimates regarding potential market opportunities for our product candidates; our ability to attract and retain key personnel; and other details in and 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, March 27, 2019.

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 may be required by applicable securities law.

With that, I would like to now turn the call over to Dr. Sean Ianchulev.

Thank you, Tram, and welcome, everyone, to Eyenovia's Fourth Quarter and Full Year 2018 Earnings Conference Call.

Throughout 2018, we worked diligently to advance our late-stage pipeline, comprised of MicroStat for mydriasis, MicroPine for progressive myopia, MicroProst for IOP lowering in glaucoma and MicroTears for red eye and itch relief and lubrication.

We also continued to validate the efficacy of our high-precision microdosing platform technology, which we call the Optejet.

And we were very excited to announce positive results from our first Phase III program, MicroStat for pharmacologic mydriasis.

The results from the MicroStat MIST-1 and MIST-2 trials confirmed that our fixed combination phenylephrine-tropicamide formulation met the primary efficacy outcome in both studies.

We believe that these studies help to further validate our microdose platform technology as well as demonstrate the potential of our technology to improve office efficiency.

In addition to our success with MicroStat, the FDA acceptance of our MicroPine IND application represents another milestone achievement, allowing us to initiate the Phase III trial this year.

We also expect to initiate a third Phase III program with MicroProst this year, which includes a single study with an expanded study population, including patients with chronic angle-closure glaucoma, open-angle glaucoma and ocular hypertension, representing what we believe is one of the broadest patient population in glaucoma drug development today.

Let me first highlight our MicroStat program and expand on our positive results from our Phase III MIST-1 and MIST-2 trials.

As you may remember, MicroStat for pharmacologic mydriasis or pupil dilation is an important estimated 80 million-plus office-based comprehensive and diabetic eye exams as well as the estimated 4 million mydriatic applications for ocular surgery in the United States alone this year.

Currently, the majority of eye care practices use dual installation of both phenylephrine and tropicamide, which can lead to dual overdose of those agents as well as increased downtime as those doses must be separated by several minutes in order to be effective.

At this time, there is no FDA-approved co-formulation of these drugs, and we aim to bring the first fixed dose phen-trop combination in the market.

The MIST-1 study was a U.S.-based, randomized, double-masked, superiority trial that enrolled 64 subjects.

In the study, both eyes of the subjects were treated on separate days with our MicroStat fixed combination formulation of phenylephrine 2.5% and tropicamide 1%.

In MIST-1, Eyenovia's own fixed combination, MicroStat, was compared against each component formulation of tropicamide and phenylephrine, respectively, using the Optejet.

The study met its primary efficacy outcome of mean pupil dilation at 35 minutes post-administration.

And the MicroStat group demonstrated a statistically and clinically superior mydriatic effect as compared to either component formulation.

Additional analysis demonstrated that 94% of the eyes achieved 6-millimeter or greater pupil dilation at 35 minutes post-administration compared with 78% and 1.6% for the tropicamide-only and phenylephrine-only groups, respectively.

We also found that at 20 minutes, 57% of the MicroStat-treated eyes achieved 6-millimeter dilation or greater compared to only 38% of the tropicamide-treated eyes and 0% of the phenylephrine-treated eyes.

Our MIST-2 study was a second confirmatory Phase III trial designed for superiority of MicroStat versus controlled placebo solution, and it enrolled 70 subjects.

In the second trial, both eyes of the subjects were treated on separate days with our MicroStat formulation compared against a placebo solution.

Both of which were administered using the Optejet dispenser.

The study's primary efficacy outcome was the same as in MIST-1 study, and MicroStat demonstrated that it was clinically and statistically superior to placebo in terms of mydriatic effect.

Additional analysis of the data demonstrated that in the MicroStat group, 90% of the eyes achieved 6-millimeter or greater pupil dilation and 68% of the eyes achieved 7-millimeter or more pupil dilation at 35 minutes after administration.

We're very pleased with the outcomes of both Phase III trials, which not only demonstrated a robust mydriatic effect from MicroStat, but also that MicroStat was well-tolerated by all subjects.

We believe that this is the first time in a Phase III FDA registration program that drugs have been delivered to the ocular surface using a microdose delivery system, representing, in our opinion, a major step forward as we seek to transform the field of ophthalmology and provide physicians and patients with smarter and more precise technology to improve delivery efficacy and compliance.

With the 2 required registrational studies complete, we have now turned our focus to preparing the registration and stability manufacturing lot for MicroStat, which are required parts of our planned new drug application.

Once we complete these steps, we expect to file a complete NDA package with the FDA in 2020.

Turning now to our first-in-class, back-of-the-eye program, MicroPine.

We were very excited to receive FDA acceptance of our investigational new drug application to initiate our Phase III CHAPERONE study to reduce the progression of myopia in children.

Currently, there are no FDA-approved therapies to treat myopic progression.

A pathologic process of unchecked sclera-retinal axial elongation, which can lead to progressive nearsightedness, decreased vision and, in advanced cases, retinal detachment and retinal atrophy.

We believe that our proprietary microdose formulation of atropine holds the potential to be the first FDA-approved treatment for myopic progression.

And our development of atropine is supported by a growing body of evidence, generated from the ATOM1, ATOM2, more recently, the LAMP studies, which were conducted by collaborative academic groups.

These studies have successfully demonstrated that low-dose atropine has the potential to slow myopia progression by up to 60% to 70%.

With the acceptance of our IND in hand, we plan to initiate our CHAPERONE study in 2019.

The single study, which we'll confirm through our discussions with the FDA will be a U.S.-based, multicenter, randomized, double-masked trial that would enroll more than 400 children and adolescents.

Participants in the study will be equally randomized to receive treatment of either 2 MicroPine treatment concentrations or a placebo arm.

The third Phase III trial we're preparing, an IND application for MicroProst for the lowering of intraocular pressure or IOP.

Last year, we published positive results from our ancillary Phase II Eyenovia PG21 study, which examined the effect of microdose latanoprost on IOP lowering.

This study demonstrated that a single administration of a microdose latanoprost using our Optejet technology achieved 29% IOP lowering from baseline, which is consistent with the 26% seen in other studies using conventional eye drop latanoprost.

After presenting these results at recent medical meetings and further discussions with the FDA, we have recently announced that we would expand the MicroProst study population to include not only patients with chronic angle closure glaucoma, but also open angle glaucoma and ocular hypertension patients.

This expansion could allow MicroProst to additionally access approximately 4 million people in the United States, who are currently being treated for elevated IOP.

In addition to broadening the patient population, we have also streamlined the clinical program to just a single Phase III registration study of approximately 250 patients.

We believe that this trial will include one of the broadest patient populations in glaucoma drug development to-date, with the potential to have one of the widest indications of any commercially available IOP-lowering therapies, including chronic angle closure glaucoma, which currently has no FDA-approved therapy.

Finally, we have also refined our fourth program, MicroTears.

After conducting further research, we believe that developing MicroTears as an ocular decongestant and antipruritic to address red eye, itching and ocular lubrication will enable us to differentiate it as an OTC product.

We believe that this updated formulation of MicroTears will be able to address the issues facing current OTC tear products by reducing the medication rebound effect, lowering preservative exposure and be significantly easier to administer by consumers.

As we continue to develop the program towards an OTC monograph registration with the FDA this year, we're considering commercializing MicroTears through our direct sales to optometrists using a specialty pharmacy network or SPN.

An SPN can simplify the traditional prescribing process by allowing a single specialty pharmacy to handle the sale and distribution of products to consumers and optometric practices.

From our research -- the recent market research, we currently believe that this will be the best commercialization path as the recent [portion] of the optometry business is very important, and the majority of doctors we surveyed indicated an interest in selling MicroTears.

We're also considering commercializing MicroStat and potentially other products in the same way.

Now before I hand the call over to John to review the financials, I would like to briefly discuss future opportunities in the ophthalmology space that our technology platform may be well suited for.

One such ocular disorder is presbyopia, which is a nonpreventable, age-related hardening of the lens that causes the gradual loss of the eyes' ability to focus actively on nearby objects.

It is prevalent, a vision-correction issue affecting nearly 113 million Americans.

Most people experience some degree of presbyopia after the age of 40.

And currently, we estimate that nearly 1/3 of presbyopia sufferers are unmanaged.

Interestingly, between the onset of presbyopia around 40 years of age and the age of 50 to 55, patients are most likely to respond to treatment.

This subset represents approximately 20 million people in the United States who could potentially benefit from a prescription drug treatment.

To our knowledge, current treatment options for presbyopia are exclusively device-based, ranging from reading glasses to refractive lens exchange.

However, Eyenovia has the potential to offer a highly differentiated value proposition in presbyopia.

Our high-precision microdosing technology, combined with pilocarpine, could provide a short-term improvement in vision in patients lasting approximately 3 to 4 hours while addressing the issue of brow-ache, normally associated with microdose pilocarpine.

While this would not be a permanent replacement for device-based modalities, such as reading glasses or contacts, our microdosing technology could allow patients to forgo such devices for several hours.

We believe that this could be an interesting development opportunity for us going forward.

With that, I would like to turn the call over to John to discuss our financial results.

Thank you, Sean.

Once again, thank you all for joining us this morning.

First, let me start with our 3 months ended December 31, 2018 results.

For the fourth quarter of 2018, we reported a net loss of approximately $6.2 million or $0.60 per share compared to a net loss of $2.2 million or $0.84 per share for the fourth quarter of 2017.

Research and development expenses totaled approximately $4.1 million for the fourth quarter of 2018 compared to approximately $1.7 million for the same period in 2017, an increase of 144%.

This increase is the result of increased clinical study and drug formulation expenses associated with our Phase III MicroStat study as well as additional expenses incurred in connection with the continuing advancement of our MicroPine and MicroProst programs, which Sean alluded to in his remarks.

For the fourth quarter of 2018, general and administrative expenses were approximately $2.1 million compared with approximately $500,000 for the fourth quarter of 2017, an increase of 335%.

This increase was the result of increased headcount and personnel-related expenses between the 2 periods as well as public company-related expenses, including legal, accounting and other professional fees from the company's initial public offering in January of 2018.

Total operating expenses for the fourth quarter of 2018 were approximately $6.2 million compared to a total operating expenses of approximately $2.2 million for the same period in 2017, an increase of 186%.

And now I'd like to review the results for the year ended December 31, 2018.

For the full year ended December 31, 2018, we reported a net loss of approximately $17.3 million or $1.82 per share.

And this compares to a net loss of approximately $5.1 million or $2.19 per share for 2017.

R&D expenses increased 191% to approximately $11.1 million in 2018 compared to approximately $3.8 million in the prior year.

This increase was the result of the continuing advancement of our 4 drug development programs throughout 2018 as well as the development cost of our Optejet dispenser system.

For the full year of 2018, G&A expenses increased 366% to approximately $6.1 million versus approximately $1.3 million for the full year of 2017, due largely to increased headcount, legal expenses and public company-related expenses.

Total operating expenses increased 236% to approximately $17.3 million in 2018 compared to $5.1 million for the full year of 2017.

As of December 31, 2018, the company's cash balance was approximately $19.7 million.

And this includes the $3.4 million in gross proceeds, excluding underwriting discounts, commissions and offering-related expenses that we raised in the follow-on public offering in December of 2018.

This concludes our prepared financial statement remarks.

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

Thank you, John.

Before we open the call to questions, I would like to thank our highly motivated team as well as our shareholders who helped us make 2018 a success.

We look forward to continuing to execute on our clinical initiatives this year, including the initiation of our Phase III programs for MicroPine and MicroProst as well as the OTC monograph registration of MicroTears.

We remain confident that we are well positioned to leverage our novel platform technology to not only deliver on our 4 main programs, but also potentially reform the treatment of front- and back-of-the-eye diseases.

With that, that concludes our prepared remarks, and we'd now like to open the call to questions.

Operator?

(Operator Instructions) Our first question comes from Matt Kaplan with Ladenburg Thalmann.

I just wanted to start off with MicroStat in terms of what are the next steps necessary to complete the NDA filing?

You mentioned some registration lots, manufacturing lots.

How long will it take to complete those?

And when do you expect to be able to file the NDA for the MicroStat program?

Well, that's great.

I know we talked about that earlier.

Now that we have the positive results in hand, we have initiated the registration lots.

And we need to get the stability readout on that, which is pretty sequential and very least time to process of 9 to 12 months.

And then we expect, based on that, we will have obviously the clinical study report and data ready from the clinical trials.

We expect to file the NDA in early 2020.

So basically, there is a little bit of wait time, partially because we wanted to see the positive results of our clinical studies before we initiated some major spend on the registration batch activities.

Okay, that's helpful.

It makes sense.

And just turning to MicroProst and the study design that you're detailing in terms of 1 study that will provide you potentially broad approval in the space, including CACG patients.

Can you help us understand how it's only 1 study that you're going to need for -- to facilitate approval rather than 2 in this setting?

Right.

Again, as you recall, Matt, we actually did a very similar thing with MicroPine.

Our initial plan was 2 registrational studies.

And then we were able to leverage a lot of existing information from the collaborative groups in MicroPine.

And actually, the FDA was really understanding.

And there is a lot of level 1 evidence in that program.

And we were able to proceed with a much more efficient path.

And it's great to see that the FDA have a sense of urgency when it comes to groundbreaking innovations.

Very similar construct is at play here where we were able to leverage a lot of information and data on -- in chronic angle closure that's in the peer review and existing data from the microdosing that we have.

And the trial design, Matt, is about the same.

We're really not changing the points.

It's a 3-month primary endpoint, and it is still with an active control against timolol.

So again, the trial design is not materially different from before.

But again, it will be a single registration trial that we have for MicroProst.

Then we just expanded it to a mixed population to include now not only the chronic angle closure patients, but the open angle and ocular hypertension.

Because we believe when we looked at the evidence and the data, that they behave very similarly in terms of IOP lowering effects from existing academic studies and data that we have.

So we were very positive.

We also felt and we were encouraged by our advisers who felt that our technology is really transformative.

And why should it be limited to a single smaller population and really not be made available to the larger population?

One thing that we're seeing, it's very interesting, too, is a glaucoma specialist who actually treats patients with glaucoma.

And we know latanoprost and prostaglandin are really the first-line treatment for glaucoma across the board and are equally used for patients with chronic angle closure and open angle glaucoma.

And we know that one of the major problems with them, in addition to hyperemia is periorbitopathy, sunken globe.

It is because of the overdosing that happens of the drug to the periorbital with the eye drops that it melts the fats.

And most of the patients actually experience orbital -- sunken orbits and orbital pathology, which are a significant cosmetic problem to them.

So we felt that given the microdosing and the fact that we reduced by 80-plus less percent the dose of the drug, in particular, with the high precision of delivering it directly to the cornea versus where other topical treatments with eye drop delivery to a neck -- to the neck side of the conjunctiva.

We really wanted to -- if we see that benefit, we wanted to really not limit it to a chronic angle closure patient when the rest of the population can have a significant impact.

And the other part with the compliance and the smart monitoring, these are really game-changing, I think, achievements if we have smart micro therapy on the market.

And so when we looked at that, we realized these benefits ought to be made available to the larger glaucoma population unless there was a really significant rationale to the contrary.

So working with the FDA, we feel that we have a very good plan forward, which would really be for IOP lowering across the spectrum of the glaucoma population.

Okay.

That's very helpful.

And then last question, in terms of just timing for -- you mentioned you're going to start the MicroPine and MicroProst Phase III programs later this year.

Any more granularity you can give us on the potential timing for that?

Yes.

I think my team is really hard at work to expedite this.

I would say we have a stronger sense of urgency to really go with the MicroPine first.

And we've had some remarkable formulation success and in the piezo qualification process, too, for our formulation.

So I have a feeling, although don't hold me to that, that MicroPine may be the first one out the gate with an FPI in -- hopefully, in the coming months.

And then MicroProst, partially because with MicroProst, we really wanted to nail down the design.

We didn't want to push with the chronic angle closure indication just to launch quickly to check the box when we had a tremendous opportunity to make a design change that can be really impactful to patients and the company.

So now that we really have redesigned slightly the program, again, we're putting it back on the fast track.

And hopefully, shortly thereafter, maybe H2 of this year, we're going to initiate the MicroProst program, which is a fairly fast-track one, as you know.

With the open angle glaucoma and ocular hypertension now being a significant part of the population, we believe that would really expedite enrollment projections.

It would be easier to enroll in the study.

And also we're enrolling and doing a single study.

So we think a lot of those benefits will be captured.

And even if we start a few months later on the MicroProst, the overall program delivery and the NDA time line will really not shift very much at all because of the other optimizations that we've been able to do.

Our next question comes from Jonathan Aschoff with National Securities.

Okay, and I'll move on to the next question.

The next question comes from Scott Henry with Roth Capital.

I've just got a couple of questions.

Perhaps I'll -- just a quick follow-up on the MicroProst.

Do you still expect to file that product by the end of 2021?

Yes.

Scott, yes, I think our expectation when we looked at the operational aspects of the clinical trial enrollment, if we don't have any intervening circumstances, again, we feel very confident about enrollment projections in the glaucoma space.

I mean, this is where we've been doing trials for decades.

With the additional wrinkle that we do have the chronic angle closure population, which has a little bit less of experience.

But now the trial is not pivoted around that, it's a part of that equation.

So yes, I think when we looked at the projections, we feel comfortable with that time line.

Okay, great.

And I apologize, I missed some of the opening remarks if any of my questions are redundant.

Second question, could you talk about the ability to partner or monetize any of the assets or indications during the next kind of 12 to 18 months?

Yes.

Scott, you're asking a very insightful question.

Again, as you've heard from the first part of the call, my team is already planning on how to commercialize that.

And obviously, we have found a very, I think, efficient path through the SPN, which would really, I think, in many ways, reduce the huge commercial burden of building a sales force.

And we're kind of lucky with the first 2 products because those products are really nonprescription.

They're more office-based sales.

And there are some streamlined efficiencies of how you can do that, particularly in today's day and age where most practices get really integrated into multispecialty networks and practices of doctors, not a single physician practice.

So it's easier to really tap that.

But that being said, it really allows us to also explore now that we have a clear commitment with the data from the MicroStat studies.

And we know now that we have a linear path to going forward.

For this, we want to see how the -- we're exploring potential partnerships on the commercialization front with people who already -- with companies who already have feet on the ground.

And then I think as the other programs materialize and we launch them with MicroPine and MicroProst, again, we are very much starting to explore licensing opportunities.

Now with that being said, I do want to also acknowledge the fact that we're very cautious of how we explore those.

As you see, we are operating very efficiently as a team and as a company to deliver that.

But we are cautious because we don't want to fragment the portfolio across different partnerships that may be haphazard and, ultimately, not aligned with the overall strategic path of the company.

So a lot of that will be happening over the next 6 to 12 months.

And again, now that we are in that stage where these programs are in late-stage and the Phase III studies are being initiated, I think it becomes a much more concrete discussion with strategics when we have that at hand.

Okay, great.

Final question, could you talk a little bit about what we should think about for OpEx on a quarterly basis in 2019?

Or -- and you may not want to give guidance, but at least relative to kind of the $6.2 million we saw in fourth quarter '18, should it continue at that rate or maybe decline a little bit off that rate or go up?

Just any color would be great.

Yes, I could go through with that.

It's actually a good question because the G&A in the fourth quarter did include some nonrecurring expenses.

And they were associated with the professional fees, associated with the capital raise that we did in the fourth quarter as well as legal and professional and filing fees associated with the shelf registration statement that the company filed at the end of last year.

So the way we look at it is we do expect G&A to come down from the fourth quarter 2018 levels where they were about $2 million.

We think that for the year, they'll be closer to a total of $6.2 million to $6.4 million for the entire year.

And then on the R&D expense guide, based upon the programs that we have in place and the current time lines, we think -- we'll probably looking at about $15 million to $15.5 million of total R&D expenses for 2019.

The next question is from Jonathan Aschoff with National Securities.

I had an awful connection last time, so it's really hard for me to know what you covered.

It kept going in and out for minutes at a time.

But I was wondering, what kind of benefit do you think you need to show in myopia to change the treatment paradigm given that there are a few nonpharmaceutical options: vision training, specialized contacts or eyeglass lenses?

Yes.

Well, Jon, I'm glad you made it, and hopefully, the connection is better.

Again, it's one of the privileges of doing that program and having been developing other programs.

I mean, for example, with LUCENTIS where you do a completely new molecular entity in a new space.

This is actually a new space categorically.

I mean, there's nothing really to speak of that's been approved in myopic progression.

I personally think that would be one of the biggest spaces in ophthalmology going forward because it's the back-of-the-eye opportunity with something that now we understand and we have an urgency to correct.

That being said, one of the privileges of doing development in myopic progressions is that we have some phenomenal landmark studies that are randomized, controlled trials, done by collaborative groups over 3. And now we have even 5-year data.

And those trials are extremely consistent in their outcomes.

The ATOM1 study, the ATOM2 study.

More recently, there were results from the LAMP study.

And it really strikes me when I read them as a clinician of how consistent that effect comes through.

So again, as we design our own programs, we are not operating in a vacuum, and also, we are not even operating with surrogate Phase I, Phase II data that normally you get to do.

And we have very, very good data points from those trials that can help us design, power and estimate the outcomes.

Our studies will have pretty much the same clinical outcomes and primary outcomes as those studies.

It will be refractive change over time, which is really one of the problems here as the eyeball becomes stretched and longer and the elongation happens, patients go from a refractive state of minus 1, minus 2 to minus 5, minus 8, minus 15.

So slowing change over the period of the study, and the primary period would be the key.

And it's been very well demonstrated that in those trials, the delta that some of them demonstrated with a low-dose atropine is well over 60%.

And that's nontrivial.

I mean, to impact an outcome of 60% or more is really phenomenal.

And we think maybe with our high-precision delivery and compliance, enhancement features of our technology, which are unprecedented, we may even stand a chance for better.

So yes, from that perspective, it's good that we have that information from the collaborative groups to inform our own trial design.

Okay.

So you would think that perhaps being noninferior with your administration advantages, do you think that would be enough?

Oh, no, no.

Absolutely not.

We're not -- these are not -- this is not going to be a noninferiority study, Jonathan.

This will be a superiority over controlled.

So as I mentioned, we will have 3 arms.

Two arms will be 2 different microdose active treatment versus controlled, which will be placebo.

So we will be shooting for superiority.

And that's what anybody would have to do in that space.

Okay.

Is there anything else likely to be late-stage or even on the market before MicroPine?

Yes.

So if you look at our portfolio, we have MicroStat.

No, no.

I mean, in myopia?

Oh, in myopia.

So there is a company that's running -- that has an atropine-based formulation in standard conventional eyedropper.

And that company is -- I think, they launched their study -- they're the first one really to explore that.

That was about 12 months ago.

So they're really -- they initiated their Phase III program earlier.

I don't know how the enrollment is going there.

But I also am aware that there is a lot of -- now because of the interesting data from the collaborative groups, everybody is gearing up, and there's a lot of interest in that space.

But again, from the other company that's already initiated a program, I'm not aware of anybody else running a Phase III study.

And I think we will be at least a fast follower, if not, with a, what I believe, will be a very superior delivery technology, which is essential when it comes to our younger patients.

I think they have a hard time putting eyedrops, and we'll provide them with a very compelling alternative and a microdose on top of that.

Okay.

But no chance of there being an arm with atropine, not given by your device, correct?

No, no.

We don't need that, and we don't plan that.

Our next question comes from Yi Chen with H.C. Wainwright.

Could you provide some color regarding the time frame that the microdosing pilocarpine is going to enter clinical study for presbyopia?

And when it enters clinical study, is it going to be a Phase II study instead of a Phase III?

Right.

Okay, that was a good question.

Let me answer it.

So we have, internally, achieved some very significant formulation success with our own pilocarpine formulation for microdosing.

Because as you know, a lot of the things have to be made, and our formulation has to be married to our piezo qualification process.

And surprisingly, we achieved some dramatic success for pilo.

And pilo was something we really explored conceptually when we did a gap analysis of where this technology really fit, where is the best beachfront and where is the biggest impact we can make for patients with that technology.

And in fact, more recently, there was -- there are trials with pilocarpine of other companies that are realizing the potential transformative resurrection of that therapeutic in terms of presbyopia.

And I believe, actually, Allergan is rushing forward with a Phase III now study on pilocarpine.

There is a lot of information on pilocarpine in Phase II data and documentation of its effect.

The issue has been tolerability and delivery, partially because of the overdose topical treatment.

So this is an example where I know we have a program on the shelf that can go directly into Phase III based on all of the data that we have and can be really acutely positioned to enter in the very, very desirable presbyopia market.

Now that being said, we're very much fully engaged with all of our other programs.

And I think somebody asked the question earlier about partnership.

That is an ideal program for us to work over the next 12 months to really partner.

Because I think that we are in really good shape in our pipeline and portfolio with our 4 existing programs.

But this is where Eyenovia can partner this groundbreaking technology and formulation to really bring one of the first topical treatments for presbyopia, which we know is a huge market.

So yes, I think that program can go into high gear at any point.

I think we are really looking forward to working with potential strategics to partner it given everything else that we have internally.

Thank you.

And this does conclude today's question-and-answer session.

Ladies and gentlemen, thank you for participating in today's conference.

This does conclude today's program, and you may all disconnect.

Everyone, have a wonderful day.