Q2 2020 Eyenovia Inc Earnings Call
Ladies and gentlemen, thank you for standing by and welcome to the I know will be a second quarter Twentytwenty earnings call. At this time, all participants are not listen only mode. After the speakers presentation. There will be a question and answer session to asked a question on that portion of the coal you Press star one well your telephone.
Please be advised of today's conference is being recorded if you're required any further assistance. Please press star in Seattle, and I'll hand, the conference over to your Speaker today Onyx Global. Please go ahead.
Good afternoon, and welcome to I know vs second quarter 2020 earnings conference call an audio webcast.
With me today are Dr. shiny entre lives I know, the as Chief Executive Officer, and Chief Medical Officer, John Gandolfo, I know he is chief financial Officer, and Michael Rowe I know he was vice president of commercial.
Earlier. This afternoon I know, we issued a press release announcing financial results for the three months ended June Thirtyth 2020.
We encourage everyone to read today's press release as well as I know he has quarterly report on form 10-Q.
Second quarter, 20, which will be filed with the FCC.
The company's press release and quarterly report will also be available and I know, there's web site at I know VR dotcom.
In addition, this conference call is being webcast to the company's website and will be archived there for future reference.
Please note that on today's call will be discussing.
Investigational products, which I've yet to receive Afghan tool.
Please also note that certain information discussed on the call today is covered under the Safe Harbor provisions of the provide private Securities Litigation Reform Act.
We caution listeners that during this call I know, there's management will be making forward looking statements.
Actual results could differ materially from those stated or implied by these forward looking statements due to risks and uncertainties associated with the company's business.
These forward looking statements are subject to a number of risks, including risks related to impacts of uncertainty related to covert 19.
Fluctuations in our financial results, particularly given market conditions.
And the potential economic impact of Koby 19.
Our need to raise additional money to fund operations for at least the next 12 months as a going concern.
Risks of our clinical trials, including but not limited to the cost design initiation enrollment, which could continue should be adversely impacted by covert 19, and resulting social distancing.
Timing Congress and was also such trials.
The potential impacts of covert 19, our supply chain.
The timing and our ability to submit applications for obtain and maintain regulatory approvals for our product candidates.
And potential advantages of our products out of candidates.
Our estimates regarding the potential market opportunity for our product candidates.
Great and degree of market acceptance and clinical utility of our product candidates.
Our ability to timely develop and implement anticipated manufacturing commercialization and marketing capabilities.
I tried to use for eggs existing product candidates.
Our ability to attract and retain key personnel.
Intellectual property risks and others detailed and unqualified by the cautionary statements contained and I know various press releases NFC SEC filings, including his 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 dislike broadcast August 12 2020.
No. The 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 said I would like to turn the call over to Dr. Shawnee onto alive.
Thank you Alex.
And welcome everyone to I know via second quarter 2020, <unk> earnings Conference call.
This past quarter, we were very pleased to continue advancing our strategic and clinical initiatives. Despite the ongoing cobiz 19 pandemic.
At the end of the second quarter, we successfully resumed recruitment of our phase three chaperone study for progressive myopia.
We look forward to swiftly completing in the ball enrollment.
And also maintaining patient safety during that process.
Over the past couple of years.
We have been very focused on our U.S. operation.
Building and executing on what is now one of the bulk advanced late stage clinical pipeline of the decline in the ophthalmic space.
We completed the Microsoft Phase three trial.
Initiated the micro paean shopper on phase three trial and now anticipate initiating the presbyopia phase three program in the coming month subject to any impacts of called 19.
More recently, we also turned our attention to global partnerships and alliances.
We're excited by the interest we're seeing in our technology and just recently took another step towards growing and monetizing some of our market opportunities outside the U.S. with our exclusive license agreement with Arctic vision, a China blade Ophthalmology company for the development and commercialization of Mike.
Grouping and micro line for the greater China, and South Korean markets.
This transaction has immediate financial benefit for I know via <unk>.
That makes us eligible to receive payments of up to 45.75 million with the potential to receive additional supply in royalty payments over the coming years.
With this agreement we believe we're well positioned when he comes to the Asian market and we're very excited to work alongside Arctic vision as we aim to unlock the major opportunities of myopia in presbyopia. These large market.
In the remaining month of 2020, we plan to submit our new drug application for Microsoft for pharmacological the dry assist.
And subject to any impact the probably the 19 to initiate our phase three visual studies for our micro mine programs for pharmacologic treatment for the up yet.
Before we discuss our clinical progress I would like to tend to pull over to Michael to highlight our agreement with Arctic vision Michael.
Thank you Sean.
Yesterday, we announced our license agreement with Arctic Vision, a China based company focused on developing and commercializing innovative ophthalmic therapies in Asia.
This exclusive partnership for the development and commercialization of micro line and microphone in greater China, and South Korea significantly expands the market potential of our products into a region, where this estimated that there are hundreds of millions of myopic children.
Many of these children and parents and doctors already well aware of the published clinical evidence supporting the use of after paying to prevent their myopia from worsening.
Additionally, there are nearly as many adults between the ages of 40 and 60 in greater China, and South Korea, well May also benefit from a pharmaceutical alternative for the episodic treatment of age related presbyopia.
Under the terms of the agreement were eligible to receive payments of up to 45 point $75 billion with additional supply royalty payments that we estimate could reach into the tens of billions of dollars.
These payments are comprised of an upfront payment as well as additional payments payments are based on various development and regulatory milestones, including the initiation of clinical research and approvals in greater China, and South Korea as well as development costs. In addition, Arctic vision has agreed to purchase micro pine and micro line from I know via.
Or for products not supplied by us Arctic vision will pay us a mid single digit percentage royalty on net sales of such products subject subject to certain adjustments.
As part of this agreement I know via will pay send you pharmaceutical a mid double digit percentage of license and royalty payments received from Arctic vision and the net proceeds of our supplier products the Arctic vision.
These payments are part of our previously announced agreement with century pharmaceutical by which we reacquired the rights to these products in greater China and South Korea.
Overall, we believe that the Arctic vision transaction is a good example of our international distribution strategy.
And will help to further grow our commercial reach to address some of the largest progressive myopia and presbyopia markets in the world.
Importantly, this transaction also provides us with non dilutive capital, which could help to further support the execution of our objectives in the United States.
Now I would like to hand, the call back to Sean to provide an update on our ongoing clinical activities Sean.
Thanks, Michael we're thrilled to partner with Arctic vision, and we look forward to advancing our all U.S. activities now I would like to highlight our clinical programs in the U.S.
As well as such upon some recent data that our R&D team has generated to further support our off the jet dispenser.
Since we introduced the off the jet we have highlighted the many benefits of micro dozing therapeutic.
Including the ability to reduce the amount of preservative being delivered.
Our R&D team recently completed some research evaluating whether our off teacher dispenser.
Tim to lever preservative free medication.
We're happy to report that the Optigrid can be qualified for preservative free multi building.
Something which could lead to grade benefits and eliminate significant away associated with the single drop containers currently in use.
Where every drop delivered has to be package individually.
Separate plastic packaging.
To put this into perspective.
This equates to approximately 352 packages per year per patient for daily use medication and more than approximately 700 plastic below feel packages per patient here with twice daily use medication.
You can imagine the incredible weight.
And environmental footprint of this preservative free.
Single unit unit packaging.
We're very happy that the opposite has the potential to lead the way in eliminating waste and improving compliance as well as accuracy of on target topical delivery.
In addition in the context of public 19, pandemic, where the virus can be spread asymptomatic really it is tantamount to reduce the risk of contamination in the physician offices.
It is critical to reduce that risk when patients have seen today.
In a recent study published in the peer reviewed journal of the American Medical Association Jama Ophthalmology.
Investigator examining the potential of call the 19 to contaminate environmental surfaces of an ophthalmology or optometry examination room.
The study found that covered 19 with president or within a one meter diameter.
Around where the patients.
Yeah.
This study is just one example of the contamination risk that we need to be aware up and indeed this increased unmet need for the realty and contamination prevention across the nation has been top of mind for our clinical partners and key opinion leader.
That's a result this has generated significant interest with regard to the off digits.
Lets clinician struggle with the contamination and exposure risk related to the cross patient use of dilating drops.
While we medicine are we done not re use things like injection needle or thermometer tips across patients. This is unfortunately, not the case with hydro per bottle, whereas this time of the did bottles are routinely reuse not big jump between two or three patients.
But commonly across 40 to 50 patient.
It is a well established by third party clinical studies that the drop or bottle often touches the ocular surface and lead.
The patient after only a couple of uses potentially introducing bacterial contamination to the medication it fell out of the dropper.
One study publishing the peer reviewed journal medicine found that at home patient administered Eyedropper bottle, we're contaminated nearly 25% of the time.
And even eyedrops used by medical personnel were contaminated approximately 20% the time.
The second study publishing the journal of investigative Ophthalmology and digital science. Similarly combat approximately 23% of the open eyedropper tested positive.
Material culture, indicating that the bacteria were coming from the handling of the drop of by user or from touching the I only 40 eyelashes with patient.
Now, while eyedropper protruding tip and low velocity drip.
Prone to touched the lids and the conjunctiva risking potential contamination.
Do you hope to just as a non contact protrusion the delivery to as well as non gravity driven horizontal prayed dispensation, which is designed for remote spray degree of delivery. So it did not surprising that the object could be a perfect solution for the pulse called reality to reduce the risk of contamination while also.
The reducing waste from single use packaging.
I'm also pleased to say that much of the interesting we opted to us it's come about because of Microsoft and we're working very hard to submit our and blow by the end of this year, two megan's vical products available to clinics.
Once and patients as soon as possible.
Let me address our recent clinical progress in the USA.
Despite the ethanol it is of probably bank loan in the second quarter. We've continued to advance our best in class late stage therapeutic pipeline.
We were pleased to announce in June that we had resumed recruitment in our phase three chaperone study for progressive myopia, among nearly all of our clinical site.
Who we have worked closely with to ensure patients and clinical safety, which remains our top priority.
Our phase three chaperone cities randomized double Mark clinical trial set to enroll more than 400 children between 312 years of age which is examining the safety and efficacy of our proprietary utrophin topical micro formulation.
Delivered in the off digit dispenser for the reduction of progressive myopia.
Subject randomized to receive treatment with either of two microplane concentration or a placebo and the primary efficacy endpoint is the change in refractive effort. However from baseline to 36 month.
Throughout the clinical polls, we continue to follow up we'd and monitor whole previously enroll chapter on patient.
Tele medicine, and remote monitoring processes and I'm very pleased to report that all patients who were previously randomize all of them to treatment have continued to progress.
Uneventfully in this study.
We're now working with our clinical site to advance total enrollment and believe that we're on track to swiftly complete enrollment.
Of course this continues to depend on the improvement of the called it pandemic and we're constantly working to ensure.
We create the safest possible environment for our everybody who will participate in our clinical trial.
As I mentioned in conjunction with our recent R&D tests around the up the Jed.
We are continuing to develop our ending April microstar pharmacologic mud dry acid.
As you remember my Chris that which we plan on marketing under the brand name Mccombie.
He is our novel combination formulation of phenylephrine and tropical lite.
These two drugs are often used together in the approximately 18 million diagnostic eye exam, and 4 million cataract surgeries performed each year in the U.S. along.
Based on our two positive mix one in mid two phase three trials.
We're working towards submitting our Indiana application to the U.S.M.D.A. by the end of 2020.
If approved Microsoft it would be our first commercial product introducing physicians and patients.
Through our high precision optics dispenser and priming the market for all future therapeutic.
Finally.
We remain excited about our phase three you're ready micro line program for the pharmacologic treatment of presbyopia.
Could be up here, which is the non preventable age related hardening of the ocular land.
Which causes the gradual loss of the eyes ability to focus on nearby object effect an estimated.
130 million people in the U.S.
Thats why was a very significant portion of those over 40 in China.
We anticipate initiating the vision, one and the vision of what could studies this year and hope to enroll bulk trials rapidly the size and availability of this patient population is relatively easy to target.
Though of course this will be dependent on the call that 19 situation.
With that said I would like to now I'll turn the call over to John to discuss the financial results.
Thank you Sean now I would like to review our financial results for the three months ended June Thirtyth 2020.
For the second quarter of 2020, we reported a net loss of approximately $5 million, a 25 cents per share and this compares to a net loss of approximately $5.3 million were 44 cents per share for the second quarter 2019.
Research and development expenses totaled approximately $2.9 million for the second quarter of 2020, and this compares to approximately $3.6 million for the same period in 2019, a decrease of 18.3%.
For the second quarter of 2020.
General and administrative expenses were approximately $2.1 million compared with approximately $1.8 million for the second quarter of 2019, an increase of 16.3%.
Total operating expenses for the second quarter of 2020 were approximately $5 million compared to total operating expenses of approximately $5.4 million for the same period in 2019.
This represents a decrease of 6.7%.
Operating expenses include approximately $633000 of noncash stock compensation expense.
As of June Thirtyth 2020.
Bunnies cash balance was approximately $10.2 million.
We anticipate the current cash resources the upfront payment received from our agreement with the Arctic vision as well those proceeds received from recent warrant exercises for provides the company with sufficient capital through at least the end of the first quarter of 2021.
That concludes our financial statements.
I'd like to hand, the call back over to show office and closing remarks.
Thank you John we believed that our recent success is continue to not only demonstrate our commitment to our mission.
But also to further validate our therapeutic approach.
Hello license agreement with Arctic vision for the development and commercialization of micro PNNT Microturbine.
In greater China, South Korea expands our commercial potential well beyond the United States.
And demonstrate the tremendous interest for our technology.
As we look ahead, we plan to submit our first then da from Microsoft by the end of 2020 and subject to any impact of copied 19 initiate our phase three vision trials for micro line.
We appreciate all the support from our team clinical partners and shareholders and a very excited to continue executing on our mission.
That concludes our prepared remarks, we would now like to open the call two questions operator.
Thank you NFL reminder, ladies and gentlemen to ask a question you will need to press star one on your telephone to withdraw your question press the pound or hash key.
Please standby lovely compiled acuity roster.
Our first question, Matt Kaplan with Ladenburg Thalmann. Please go ahead.
Hi, good afternoon, guys. Thanks for taking questions.
Just wanted to.
Get a little bit of an update on the micro stat and da process I think you've mentioned before that.
Let me step there has been stability studies.
For the product have those been at all.
Impacted by the Cobi 19, pandemic and could that have a have a impact on on the timing.
Matt Good question and thank you.
He answered the quick after is not materially we Oh, we are still tracking and were very thankful that thats the case.
Because it could have been.
But our partners and also our internal team has the foresight to prepare and execute a during this.
I am dynamic and I think a at this point were tracking well, we'd the plants to submit the NDA by the end of this year and we hope that doesn't change.
Okay very good and then.
With respect that where are you and what are your thoughts in terms in terms of commercializing micro stat and preparation for commercialization, yes, yes.
Yes, you could potentially get approval by kind of middle of next year on this call it.
Yeah, and I will I will turn back to Michael I think he would be able to give you the most.
Formed out there I won't say just as we mentioned in our earlier discussion.
We have seen enormous interest in our technology from the community from the.
Clinicians.
Who in this post college reality I understand the need for a much.
More fair all friendly delivery and the dispenser seems to provide as you as it would discuss some of the characteristics of the off the agenda, such an inherent you need to design for remote delivery and won't touch delivery. So we've seen a lot of interest in bound by clinical sites, particularly the ones that are in our study.
That would like to have that today in order to provide better care and and so we are really on it.
The team, we want to make sure everything possible to get this into the Kansas patient the clinicians.
And patients as soon as possible because because of coffee, we realized the unmet need has even increase and the reality such that we're feeding on a product that can really help in this respect so we definitely want to get it all the nears the clinician personally I want to kick in my own practice.
This too I might patient, but Michael yes lease a comment on the direct them to commercialization.
Yeah, My pleasure Madden and good to speak with you one thing that Sean was alluding to is we just finished their second round of market research on mid calm the interesting thing was prior to co bid.
Doctors were reusing these eyedropper bottles across 20 or 30 patients each and now in a post hope is world there either limiting that to whatever number they see during that day or they're going to go to a single use which is going to be much more expensive and why that's important to consider is that one of the things we were doing from a strategic.
Good point of view is we wanted to eliminate they cost difference between our new technology and what a the doctors were currently using and that May turn out that because of co bid what they're currently using this actually going to become more expensive and while we certainly wouldn't take advantage of that it does give us the possibility.
Of having more more ways that we can move around with price than we thought before so that's one of the positives that come out of this in terms of actually selling the price of the product. We're expecting we're looking forward to a launch.
Third quarter ended the third quarter next year, we're going to start small probably with about a dozen key account people who will be located where the biggest accounts are in that would just be your group practices that see lots of patients.
And we'll start there and we'll move out from there the nice thing about a product like this was it does it require sample drops or other things either that you see what the traditional ophthalmic pharmaceutical product. So it's the kind of thing where you can go in doing introduction make sure that people know how to use the product.
Set them up on ordering and then you can move onto the next office and not have to service that all that often.
I'm, sorry thing else I can answer for you.
That's great that's very helpful.
Good and just another couple of questions if I if I might.
Congratulations on the Arctic deal looks.
Good I guess a question maybe for John with a with a 45.75 million.
In upfront and other milestones at how should we think about that in terms of extending your cash runway or is that kind of incorporated into your guidance that you you provided in terms of first quarter 21.
Yeah. So very good question so.
As we previously stated we will require additional capital to to execute our strategy over the short term as well as long term. So the recently announced Arctic vision transaction as well as some other strategic transactions that were.
Pursuing.
Similar in structure to the transaction.
I, just with the current and hopefully a potential future source of non dilutive capital. So so we're continuing to pursue these strategic transactions and we're optimistic.
To the extent that we need to raise equity capital.
We'll be opportunistic and we'll look to do it in the most efficient way possible in order to diminish minimize any dilution.
But in terms of the impact of the Arctic vision deal.
As we mentioned in our 8-K, the upfront payment was $4 million. So that balanced set of milestones are expected to come over the next four to five years. So.
It will definitely help us significantly over the long term capital needs, but we'll continue to to have a shorter term need for capital as we look to execute our strategy.
Okay. That's very helpful and last question for Sean.
And Mike Line program, you mentioned that you are continuing on chart track to launch the phase three vision trials. This year do you intend to run those both vision trials in parallel or will they be Montana.
Yes. Good question I don't think I can give you a clear answer on that were evaluating almost daily the standards of all the clinical signs.
Because as we move forward, we're going to move we that trial very fast and efficient.
We're going to have a very few science and this trials, we hope to enroll within less than a month.
And we hope to have result, literally within the following one or two month.
So we're talking three to six month to complete bulk enrollment and get the phase three results of bulk trials.
Ginger cloud because the VP of operations. She has a lot of experience and you have them all just base and.
She executed beautifully on the missed one and missed two trials as you remember those were done in a few months.
So we're going to really do what's best for the patient safety in this environment at the same time, what makes more sense I can get very quickly, but regardless of which way we go whether its a.
Slightly sequential or fully sequential or completely in parallel.
Those who will be very cost base studies.
Great great well, thanks again, congrats on progress.
Thank you Matt.
Thank you. Our next question is some new Tan with H.C. Wainwright. Please go ahead.
Hi, This is blared Colin on for you just a couple of questions from us.
Could you comment on the CB the speed of enrollment for the chaperone trial that you've seen in July August. So far are you are all sites enrolling now and have you added any new site.
Yeah pretty much all of the sites are up and running or your final stages of activation.
You know, we decided and we give them that guidance before they were not going to update.
Periodically on how many patients are in the study.
I think what's probably more relevant and meaningful ways that we expect the over the next nine months or so too.
Hopefully completing enrollment and again I'm, saying that with all the caveats today that if we see a second wave or a third wave or I really exacerbation, particularly in certain geographies, where we have clinical site.
We obviously have to do we'll try to patients and parlor clinical partners. So I.
I think we are doing very well and internally, we're tracking with or even better than what we thought we would be doing at this time.
After we realize where we are we'd call bid.
But at the same time, we're holding our breath, because we really.
Don't want to be in another situation in a few months, where we have to discontinue again the machine. The ginger has put in in the enrollment of machine and really the clinical operations is running so smoking ban it sofa phase.
We're still looking to and they're all very fast and also initiate into same time window into same breadth, while doing the NDA submission.
Execute on the two phase three footprint the up yet and again, let's not forget I know obviously, the the company. We only 30 people. So so yeah, I think where we're doing very well and were very happy where we are we chapter on.
Okay, Great and then in regards to Arctic vision deal do you expect to receive any milestones before the end of 2021.
Ah, Yes, we do.
Well the end of 2020 or 2021, what was the question.
Both.
Well, we expect to receive before the end of 2020, so would answer both questions.
We do expect to receive a milestone before that.
Okay, Great. That's it from me thank you.
Thank you short.
Thank you. Our next question is from Michael very sick with National Securities. Please go ahead.
Hi, Thank you.
[laughter] wasn't my question, but I just want to pull off on this last one.
Is there any way you can sort of.
Talk about.
What these milestones are the ones the closest ones and how much money we're talking about.
Or no.
So were were prohibited contractually to get into details like that and disclosed publicly.
I can tell you that no nature, the nature of the milestones or or typical but what you would see with other.
Drug licensing type deals regarding you know approvals regulatory oriented approvals and things along those lines.
In addition, this stuff this transaction does allow us to get reimbursed for some of the development expenses as well.
But I.
Unfortunately, I just can't give you details per mile stones.
No it totally understandable.
Omnis any V deal.
I noticed that doesn't.
Fall micro stuff, which is your most advanced Juan.
Were they not interested in that are too well, let me put a different way do you have other.
Into national.
Thoughts about Microsoft.
Mike.
Yeah, Yeah, Yeah, let me take that if you look at the market opportunity in these countries the opportunity for.
Myopia control with micro pine and even presbyopia with micro line is so far and away larger.
Especially the larger than United States.
Just because of the population and the number of children another impacted that those with the two places they wanted to go to first.
From Microsoft that which is really based upon a number of exams. It's not that the product is not attractive. It's just not for them and the same league as the epidemic of myopia.
Okay.
Going back to them off milestones remark upon the marker line and I know, there's not much you can talk about.
Oh, the milestones based on your progress.
Here.
Thank you Wes.
They are you still on the progress in Asia.
The primary primarily based upon Asia.
About progress going to those drugs in Asia.
I think John we'd probably say, though some of the development ones are based upon our actions here.
Oh, Yeah, Yeah, I was only talking about the license fee milestones correct right.
Yes, so both.
Okay.
Thank you.
I know, it's big market for her and have you had talks with anyone in Europe about this as well.
Yeah. So let me answer this again as we've spoken before and we've been very clear I know via was really busy and we were very focused on the U.S.. We wanted to first things first get our pipeline here because this is where our biggest opportunity is for now and only recently.
Almost six to nine months ago, we really started investing and spending time on partnering and licensing and in fact, I probably think it's fair to say that after we reported the positive phase three results of micro stuff, which is now going to be mid Colombia.
The we saw tremendous pike.
Inbound interest.
So it was hoping that it actually was very distracting for small company to really see through that so I think one of the first product of that is our deal with Arctic vision I think John mentioned earlier.
That we're working right now and we're spending a lot more efforts, especially with Michael.
I think the BD effort.
And we probably would see more and more in that respect as we should as our programs mature and as we come in we have to phase three trials underway here, we're going to start turning our attention to other markets like Asia, obviously for Europe, it's even easier for us because I know via.
All of the markets in Europe, there and they're really we'd be in our scope. So I think where you're going to see a lot more hopefully we can never predict when and how and who but were very diligent in terms of selecting partners, particularly in Asia.
Well, we have seen a lot of interest from a from a different entities, but oh, let's let me say that we are as we said extremely happy that we're cooperating with Arctic vision.
Because they came out on top in terms of expertise and and partnership you want to select the right partners in that market and so where we think we have the right partners that came through all of our diligent process.
And we are going to start doing a lot more of that and feeding through that inbound interest.
In collaborating and licensing with us.
Great.
You guys have been very good from our clients.
It's been great. So thank you appreciate it.
Thanks.
Thank you and I mean, mango, ladies and gentlemen, if you have that question just press star one to getting next year.
Our next question is some land gassy with stock Dock partners. Please go ahead. Thank you very much had a couple of quick questions for you guys.
First is on the phase three vision state from Micrel line, how long should that take to complete.
So so again just to be clear I'm, sorry, if if oh, we may have confuse you. It's actually a phase three study not a phase two study.
But it's the vision, one and vision two studies <unk>, yeah. So so their vision wanting vision to two trials identical and and they're part of the same phase three program.
And if it's a program that were where if you look at it for because I don't want to get we already talked a little bit about sequential parallel, let's not talk about that again, but if you think about it as the whole program because you need to complete the whole thing the problem, we hope to initiate that program.
This year by the entity here and we hope to complete that program, we take three results from the entire program.
Probably sometime in May the next year. So it's an extremely fast paced program. These are trials that we expect to enroll quickly and we expect to complete quickly and again I'm still saying that with all the caveat that we're planning.
Reality, where we're not having any reserve agents and we don't having a pandemic resurgence and closure of sites and everything else but.
Again, we have readiness and I think the team has executed before multiple times, and we know exactly which side how quickly and we've already gotten feedback we have the protocol ready and we hope to initiate that probably because it's a really phenomenal opportunities for the first time treating crespi, albeit with a with a pharmacology.
Yes to eliminate the hardware the spectacle that people use.
It's a groundbreaking approach and we've seen that by far off the charts response in our market research that Michael has conducted so so this is coming soon it's coming fast and furious hopefully.
Well noted on a trip over with some extra nowadays we called it the situation and we'll keep you updated great in terms of the cash.
You mentioned that should last through I believe the first quarter of 2021, both what you exited the quarter within the Arctic fishing upfront $4 million does that.
Projection of Q1 21 not include any cash you may receive from any.
Yes, no licensing agreements with companies.
Between now and the ended the year and I was wondering if you could comment given the advantages of optics yet.
And the fact that there are several ophthalmic companies out there that would probably benefit from being able to incorporate got the jet has a delivery system for their own pharmacological agent could it be possible. In addition to seen some of your drug licensing that.
There may be interest in companies as opposed to countries licensing you're off to jet technology to incorporate has a drug delivery capability.
Yes, So let me start with your last question and then jump can answer the person, but I like how your threading the needle on your logic, which is perfect and obviously to Ken I mean, we can make every pretty much every topical drug that currently has over doles, then and called the side effects and inaccurately delivered and all that all the benefits we've talked about we can make.
That better.
I think we don't have unfortunately, you know from all a g., we don't have the same vibrant space of strategic.
And established companies as we have you don't call energy and other space, but we do have some and actually I've been very successfully at selling technologists with them before and what we've seen as I mentioned in the recent months, especially after the phase three data, especially <unk>. Shortly after we reprioritize our pipeline and we made it laser focused on micro.
Pain.
For for a huge market multibillion dollar opportunity in the U.S. for progressive myopia, which will be the first half a topical treatment of a backup the eye disease. I mean, I was the involved into developing a blue scented, we're still injecting drugs in the eyes with patients and here, we can impact the back of the I progressive myopia with collateral retinal healing games.
And pathology, which is almost as we called the epidemic behind the pandemic and again I think people are waking up and we've seen tremendous interest in that of course.
We're very cautious does a very core assets for us.
We are not going to obviously part with them easily it has to be the right opportunity the right deal.
And everything is going through real discussions and review internally with the board and support so.
Yes, if the opportunity on the right opportunity comes a we definitely.
You know, we will consider it but right now the transaction on hand is the Arctic vision and we're very happy about that because it was not ever a milestone that was expected or we ever talked about.
We still have all of our milestone.
Or can be barring the cookie jar, we'd all the end the aid the phase three trials and everything else. This was an additional.
Good news and it happened pretty far because the teams were very motivated and we'll see what happens but for US obviously, we want to make sure.
That a if we consider some partnerships either on our programs or other programs, they're not distracting from our core mission of executing on our clinical trial. So everything we'll have to be thought out operationally strategically and financially.
And as I said, we've just started focusing on that now that we've lowered into pipeline and and and we were executing very smoothly from internal perspective, and we hope you guys. You will see more of that and we hope we'll see more of that too.
As a as this up to jet technology becomes hopefully one day standard of care.
Because like I said I would not imagine why would anybody and use the rotary phone today, when we have mobile phones I'm sure there, it's somewhere or rotary phone that somebody would you.
I think hopefully in the future I would not want to see why would anybody use an eyedropper when you have in oxy jet defensive.
Yeah, My rotary phone is avocado colored and still things on the wall on what I was wondering lastly is could you discuss because you guys have a great sense of what's going on in the market with other companies on the competitive position for the couple of other companies that are working on atrophied in progressive.
Myopia.
Yeah, I mean, basically I think there a couple that a private companies, they're all using the same eyedropper paradigm and just the or a modification aren't a formulation of atrophy.
They like US have realized probably ahead of everybody else the big opportunity of Progressive myopia. This is a huge market.
This is a huge unmet need.
Because it's our kids that are losing their site, it's our kids that a good getting myopic in Asia. This is 80% of the kids and in some countries like timeline right now 80% of all children are on occupancy today.
So we have an amazing opportunity to inflect the therapeutic index for the treatment of this disease in some of the studies, we've seen almost 70% reduction.
Reduction of progression in progressive might be so I think it's it's no wonder that multiple players are going there now I can tell you with the Eyedropper. We've seen a studies have shown that half of the time patient needs. There I hand, the cannot put it in and these are adult patients.
If the adult patient there I and the cannot put in an eye drops think about what that number useful for pediatric patients and more importantly, what we've seen in our clinical study of micro can we the chaperone that now almost 90% or more of the patients of the actual kids are self administering that.
Just like they are using that iPhone and they love it that parents are not putting the hydro.
So again that just highlights that when it comes down to options in the future. If you could have a number of companies out there I cannot see why would anybody using eyedropper. When you have an off the jet dispenser, particularly in that population and where are you, giving a micro dose of atrophy in which is an ongoing nurturing drug with defense.
Nick absorption why would you want to have any systemic absorption of a topical treatment. When you can meaning mines that we microscope. So we're looking to a very good.
I think outlook in horizon.
For Cottrill pain, and we think when there are multiple players there it will come down to delivery.
Just close with the comment that one of the consequences of this tragic pandemic may be an increase in incidence of the disease, just because of the much greater amount of time that children are spending indoors looking it either I phones are computers, and not being outdoors and the Sunshine.
So it's unfortunately may increase the incident.
Yes, that's right.
And let me just Tonight, we talked about it during our last call.
What you're saying has actually been quantified in epidemiologic studies.
Which have shown through the last few years, how much an extra additional hour of staying in front of a computer screen actually increases your progressive myopia read anything the 20% plus.
Now imagine how many additional hours kids, including my own spend in front of the computers to date doing remote learning. So so we're going to see that again. That's come then it's going to make the epidemic of progressive may help yes.
Usually escalated.
So we're already seeing doubling and tripling of that rate over the last few decades, we're gonna see something even more if the remote home based learning for six which is a great solution to the problems. We haven't disclosed today at the same time, it's gonna have the unfortunate byproduct.
Complicating progressive myopia, and that's why we think we need to get this product to patients and and particularly to kids and their patient and their.
Parents early because once you progress we progressive myopia you can Mel.
On progress once your eyeball stretches and your Claritin retina stretches and you cannot go back and now.
Shrink it back to where it should so so it's a it's an important thing to keep in mind and I think it's an important disease and we we're really happy to execute very fast here to get this as quickly as possible.
It's one of our topmost priority and again not for US only you ask the I think somebody asked about Arctic vision why are they doing dilating drops well because you need to do I think the much more important and a much bigger markets is the biggest unmet need now have a major global epidemic, particularly in China and Asia full progressive myopia.
And that's why you're going to spend your your capital and attention at least at the beginning.
Great. Thanks, so much.
You're welcome.
Thank you and we have a follow up from Michael Gresik with National Securities. Please go ahead.
Yeah [laughter].
Obviously for prescription drugs.
Isn't that are prove.
They still have to do trials with.
You are up to chip.
Because it's a different delivery system.
What about and this is a licensing.
A question what about over the camera drones to they have to go through some sort of trial sort of thing if they want to adopt fuel technology as opposed to drop is well have a february.
Yeah. So everything is different against every indication is different.
But it's a very far outpaced validation and clinical process. Because you don't have to go through phase one phase two.
Literally for him established product, whether it's a pretty prescription product, it's a very simple.
Development path.
And and this really is a great advantage of this technology.
My Codells and for over the counter like artificial tears and we've talked about artificial tears.
Before and some other it's actually even simpler easier and I think where for us what that means for us we really need to schedule, our prioritize preorder season prioritize our schedule at the same time, we need to tackle the biggest opportunities and the biggest unmet needs first I think for.
All of the omni each and onto redness medications and dry eye over the counter it's a perfect use case for the LT jet.
But right now we're focusing on the bigger unmet needs of course is this technologies into cans of a big strategic and they can literally invest in car, allowing 20 program to take the market and really differentiates goes over the counter it's completely on differentiated.
And it's begging for a differentiated product of course in that case. It can go much fostering parallel but for US up we have now three programs very high value.
We're very conveys the blade focus on them and and you know after a weak.
Come to the end of that runway and we were satisfied of where we are and we can redirect to some others, we'll do that but for a small company. Even three late stage programs I don't think there are many other develop them all energy.
Got a publicly traded companies doing that.
Right.
Finally, sorry about this but this is one of those out of the ballpark questions.
Are there other drugs that are not ophthalmologic, but.
Who will be.
Deliberate through the yard.
Have you thought about.
Right.
Yes, I I think we have and there are.
And again.
We have some efforts initially in turn all that.
Our also in a early stages and potentially we're looking at opportunities there too.
Given that some of those that would also be in the scope of a in the area of proprietary information or intellectual property.
I would not want to comment on that but again, you could deliver and the up the jet technology could also be is not necessarily for the.
You know you can do for potentially in the Miliband, the tympanic membrane or in the year. So there's a lot of application.
Of what we're doing which is the micro array print technology, where inkjet printing micro droplet seen a very precise stream on a surface and one can really.
Come up with a lot of applications and we're thinking about that as we grow the intellectual property and all that happens that we have so many patents now in ophthalmology and we're starting even beyond so very good question something were thinking about more on the R&D side, but I appreciate.
Regardless.
Great. Thank you very much again.
Sure.
Thank you and this concludes our key any sounds like today I would like to turn the call back to Sean you ancillary Funky finally lot.
Yes.
I think a enough that today I think it was a very productive tall and very interesting questions I want to thank everybody.
First thing late the Fivethirty out here on the East coast and thank you for a bearing without getting all this detailed update a lot it's happening at I know via with multiple phase three programs.
Now collaboration multiple market and we call next time, when we reconvened out for the next earnings call, we'll have more details and a further progress to report so for everybody. Please stay safe and thank you for tracking with us.
And with that ladies and gentlemen, we thank you for participating in today's program you may now disconnect.
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