Q1 2020 Earnings Call

[music].

Good morning, everyone did oyster point pharma onset to study result in first quarter earnings conference call I will be your operator today. After presentation. There will be a question answer session. At this time I would like to surgical over to Mr. Daniel Walker.

The Companys Chief Financial Officer. Please go ahead.

Good morning, everyone and welcome. So we should point conference calls and Scott topline results for the phase three onset to clinical trial in patients with dry disease.

This morning, we issued to press releases, one covering topline results from the phase III onset to trial as well as the company's first quarter 2020 financial results for the three months ended March 30, Onest 2020 volt press releases as well as the onset to slide presentation and our form 10-Q that was filed with the FCC as morning Alright.

Bill on our website at Www Dot Oyster point Rx dotcom join us on our call today are Dr., Jeffrey now President and Chief Executive Officer of Oyster point Pharma and Johnson is Urenco, our chief commercial officer I will provide a brief overview of the Companys financial results for the quarter ended March 31 2020.

Following these remarks I will turn the call over to Dr. Jeffrey now to discuss the onset to phase three results. After Dr. knows prepared remarks, we'll then open up the line for questions.

This conference call contains forward looking statements regarding future events in the future performance levels to point Fourm forward. Looking statements include statements regarding oyster point is possible or assumed future results of operations expenses and financial position business strategies, and plans research development and commercial plans or expectations trends Mark.

And sizing competitive positioning our beliefs regarding our clinical trial outcomes, including secondary endpoint analysis predictions regarding product approvals or the FDA and our efforts to manage the impact of cold in 19 and industry environment and potential growth opportunities. Among other things. These statements are based upon information.

Able to the company today and it was your point assumes no obligation to update these statements that circumstances change future events and actual results could differ materially from those projected in the company's forward looking statements additional information regarding factors that could cause results to differ materially from our forward looking statements are described in greater detail on the company's press release issued.

This morning.

Now, we'll provide a brief overview of oyster 0.1st quarter 2020 financial results for three months ended March 30, Onest 2020, additional detailed our quarterly results can be found in our form 10-Q.

For the first quarter 2020, Oyster point pharma recorded a net loss of 16.5 million compared to a net loss of 3.8 million for the same period in 2019.

As of March 30, Onest 2020, cash and cash equivalents were 130.6 million compared to 139.1 million at the December 30, Onest 2019, we believe that the company's current cash and cash equivalents will be sufficient to fund our plant operations for at least 12 months from the issuance state of today's form 10-Q.

Research and development expenses for the first quarter 2020 were 11.3 million compared to $2.4 million for the same period in 2019 to increase in research and development expenses was primarily due to our advancing both seal one and reflected an increase in expenses related to see arrows in CMO, the 7.8 million and an increase in payroll on personnel related.

Expenses, including salaries bonuses benefits and stock based compensation expense of 1.1 million.

General and administrative expenses for the first quarter of 2020 were 5.6 million compared to 1.6 length of the same period in 2019 to increase in general and administrative expenses was primarily due to the expansion of our organization and reflected an increase in payroll and personal related expenses, including salaries and bonuses benefits and stock based compensation expense.

One 2 billion an increase in professional fees for legal accounting and outside services order operation as a public company of 1.8 million and an increase the marketing expenses of point to mine.

Now I'd like to turn the call over to Dr. Jeffrey now. Please go ahead.

Thank you Dan and thank you to everyone for joining us this morning.

Im hoping that everyone and their families are safe and healthy during this unique timing our lives.

I would like to take the opportunity to acknowledge the patients the eye care providers and staff that were involved in the onset to trial. The onset to study began enrollment in July of 2019 and completed in March of 2020, as the Corona virus pandemic began to impact the U.S. and the healthcare system in general in March.

We were fortunate and honored to work with such an amazing group of investigational centers in patients who continued to safely collect the clinical data needed to complete the treatment phase of this phase III study.

Those of you following along with the slide deck that we made available on our corporate web web site. Please refer to slide number four.

We are excited to be announcing today the positive outcome in our phase three onset to clinical trial, which has been designed to investigate or steel one nasal spray as a treatment for the signs and symptoms of dry eye disease.

The onset to study met its primary endpoint with both the 0.6 milligram per mill and the 1.2 milligram per mill doses of OTO, one achieving a statistically significant improvement in schirmer score as compared to control at day 28 or weak for.

This result also translated into a statistically significant improvement in the secondary endpoint of mean change from baseline and Schirmer score at week, four and both doses consistent with our data from the onset one trial.

Benefits were also seeing on a number of secondary endpoints in the 1.2 milligram per mill dose group, including the mean change from baseline on eye dryness score in the clinic environment at week, four and as early as we to.

Today's news is a major milestone for the Oyster point pharma team as we look toward the filing of our first NDA in the second half of 2020.

Please turn to slide five.

The design of the onset to study is summarized here on slide five.

As you will see the onset study is a multi center randomized double masked placebo controlled phase III trial, which we initiated in July of 2019.

758 subjects, who are at least 22 years of age with an eye care providers diagnosis of dry eye disease were randomized to receive either 0.6 milligrams per mill or 1.2 milligrams per barrel.

Or placebo twice daily for four weeks the primary criteria for enrollment was having an expertize schirmer score that was 10 millimeters or less at baseline.

The primary endpoint of this study is the percentage of subjects with a 10 millimeter a greater increase from baseline in schirmer score at week four.

The and Thats the tie Shimmers test is an objective measure of the amount of tier film produced over the course of a five minute time period by placing a strip into the lower laid margin.

He secondary endpoints include assessing eye dryness score within the clinic environment as well as the controlled adverse environment at week four additional secondary endpoints included.

Assessment of inferior corneal staining as well as I dryness score assessments in the clinic at week too and we want.

Please turn to slide six.

There are a number of important aspects of the oyster point clinical development program and the onset to clinical trial in general that are important to understand when interpreting the trial results.

Pivotal dry eye trials have been consistently designed with placebo running phases. This design element is not a part of this trial and has not been required in any of our clinical trials.

In the onset to study there are no eligibility requirements for dry eye dryness score and therefore subjects with a wide spectrum of symptom severity are included in this study population. So the wide spectrum of symptom severity are included in this study population.

We feel that the design of the onset to study will translate into clinical trial outcomes that generally reflect real world settings relevant to a broad population of dry eye patients.

The onset to outcomes will also ally allow eye care practitioners to translate the clinical trial result into practice and strategize how to use this product in their treatment armamentarium.

In this study we use the National Institute corneal Florentine grading scale and although this study is not designed to show a benefit in corneal staining due to the compounding factors of prepare cane use at multiple visits as well as the use of the controlled adverse environment.

We did see a staining benefit and the onset one trial and therefore will investigate staining in this trial.

Please turn to slide seven as you Steve from the study demographics. The treatment groups were well balanced with regards to baseline characteristics of Schirmer score and eye dryness score subject age and baseline eye dryness score represents a much healthier population than we typically see enrolled in dry eye clinical trials with an average baseline dry.

Hi, drawing a score of 58 millimeters.

The population is also consistent with dry eye disease epidemiology and at the population contains predominantly more females as compared to Bill's.

Baseline Schirmer score is consistent with baseline characteristics as seen from our previously completed on that one clinical trial.

Please turn to slide eight.

Here you see the primary endpoint, indicating statistically significant percentage of subjects, achieving a gain of 10 millimeters or more in both the 0.6 milligram per mill and 1.2 milligram per mill treatment groups as compared to placebo.

For the responder analysis of those subjects, gaining greater than or equal to 10 millimeters on Schirmer square a week for 44% of subjects in the 0.6 and 47% of subjects in the 1.2 milligram per mill treatment groups achieves the change from baseline and Schumer square at week, four as compared to 26% of subjects in the control group.

Please turn to slide nine.

This slide illustrates the consistent and reproducible data.

From both the onset won and onset two studies for this endpoint as you see from the comparison the control group has a higher responder percentage any onset to study supporting the fact that the baseline characteristics resemble that of a healthier population included in the onset to study as compared to onset one.

Please turn to slide 10.

Illustrated in this slide the secondary endpoint of mean change from baseline and Schirmer score at week four.

As with the categorical primary endpoint statistical significance was achieved in both 0.6 and 1.2 milligram per mill treatment groups as compared to placebo subjects in the 0.6 milligram per mill treatment group had a mean increase of schirmer score.

Of 11 millimeters, while subjects in the 1.2 milligram per mill treatment group had a mean mean increase and schirmer score of 11.2 millimeters as compared to a mean change of 5.9 and the control group.

Please turn to slide 11.

This slide again demonstrates the consistent and reproducible data as compared to the onset one study for the mean change in Schirmer score endpoint.

As you can see from the comparison the control group is higher with regards to the mean change in Schumer score in the onset to study consistent with what we see with the categorical endpoint.

Please turn to slide 12.

The secondary endpoint of mean change from baseline that I joined a score a second temper mill treatment group and although there was a directionally significant in the wouldn't six milligram per mill.

Treatment group as compared to placebo is not statistically significant subjects in the 1.2 milligram per mill treatment group had an average reduction in dry eye dryness score of minus 22.5 millimeters as compared to a minus 15 point.

Eight millimeters in the control group.

Please turn to slide 13.

In this slide we see the comparison in the onset one trial, where there was statistically significant improvement in the 0.6 milligram per mill dose group and not in the 1.2 milligram per DAU mill dose script and onset to where we have balance baseline characteristics, we see a clear dose response with.

Two milligram per mill dose group performing better than the low dose.

Please turn to slide 14.

The secondary endpoint of mean change from baseline and I drawing a score assessed in the clinic environment at week to was statistically significant in both the 0.6 and 1.2 milligram per mill treatment as compared to control subjects in the 0.6 milligram per mill treatment group had an average reduction in drop I.

Turning to score of minus 16.5 millimeters, while subjects in the 1.2 milligram per mill treatment group had an average reduction in eye dryness score of minus 17.9 millimeters as compared to a mean change of minus 12.8 millimeters and the placebo group.

We believe that this highlights the early benefit of OTO, one nasal spray on symptoms and will be important for patients that are seeking relief from the irritation and discomfort associated with dry eye disease.

Please turn to slide 15.

Here, we see the secondary endpoint of mean change from baseline and I joined the score assessed in the clinic environment at week one.

Although there was a directional benefit at week one in both doses neither dose was statistically significant.

Please turn to slide 16.

This slide summarizes the improvement in symptom scores overtime in the onset to clinical trial, where we see a consistent increase in the magnitude of effect in the 1.2 milligram per mill dose group overtime discontinued therapy.

Please turn to slide 17.

The secondary endpoint of mean change from baseline in eye dryness score assessed in the controlled adverse environment that week for was not statistically significant and either the 0.6 or 1.2 milligram per mill treatment groups as compared to control.

As you will see the sample size of the endpoint was impacted by two main factors that affected the analysis and reduced sample size significantly.

The Corona virus pandemic impacted a number of sites, who did not feel comfortable putting their staff endorsed subjects into the controlled adverse environment chamber as the pandemic was unfolding.

In addition, a number of subjects in each group were asymptomatic and therefore did not meet the criteria for treatment for the full two hours while in the chamber.

We were in contact with FDA prior to database lock in were instructed not to change our statistical analysis plan due to the Corona virus pandemic at that time since I'm asking the database we have discussed with the agency how to address this endpoint and we will do so in the context of the NDA submission.

Please turn to slide 18.

We do feel however that this rich dataset is useful and highlighting the benefits of post deal one nasal spray for patients.

Slide illustrates the symptom score assessment before the subjects enter the controlled adverse environment as you see subjects in the 1.2 milligram per mill treatment group had a statistically significant reduction in eye dryness score of minus 19.3 millimeters as compared to a mean change of my.

Minus 14.7 millimeters in the placebo group.

What is most approach impressive about this statistically significant reduction symptom score is that the last dose of owes deal one nasal spray was administered to the subject the evening before as the protocol for the chamber specifies with holding morning treatment a timeframe that could have represented as long as 15 to 18.

Hours prior to the symptom assessment.

We believe that this illustrates the durability of the symptom reduction effect seen with OTO, one nasal spray.

Please turn to slide 19.

This line graph represents mean eye dryness score in the controlled adverse environment for the full two hours the subject our place in this low humidity, hi airflow environment.

As illustrated in the graph the 1.2 milligram per mill dose group shows at persistent and significant separation from placebo that continues to flatten and separate overtime.

We believe that this data illustrates the ability of OTO, one nasal spray to resist environmental change in this and burst and this adverse environment.

This chamber simulates conditions, such as one would experience and an airplane or forced air heating environment that exacerbate symptoms in many patients with dry eye disease.

Turning to slide 20.

In fear of corneal floor seen standing in this study was assessed using the National Eye Institute foreseen, stating scale.

Although this study was not designed to assess corneal foreseen staining due to the regular administration of prepare Kane for and that's the tie shimmers testing and the potential confounding caused by the controlled adverse environment results indicate a directional benefit favoring the 0.6 milligram per mill dose group on infill.

Earlier and nasal standing although there was no statistical benefit in any of the corneal regions.

Let's turn to slide 21.

[noise] as illustrated by this slide although not statistically significant there wasn't directional benefit and all foreseen corneal staining region favoring the 1.2 milligram per mill dose group.

Please turn to slide 22.

In summary, the primary endpoint of categorical change in Schirmer score was statistically significant in both dose groups as we're a number of secondary endpoints in the 1.2 milligram per mill dose group.

As stated in earlier slides, we will be discussing the secondary endpoint of need change in eye dryness score and the controlled adverse environment at the time of the submission of the NDA.

Please turn to slide 23.

We believe that the onset to trial data with support from the results of the previously completed onset one study well supported indication of signs and symptoms with clinically meaningful data that will be useful to the patient and the eyecare practitioner.

In the 1.2 milligram per mill dose group, we see a statistically significant increase in natural tier film as compared to control.

In stimulating the production of natural tear film, we see a statistically significant improvement in symptoms as early as we too with increasing magnitude of effect at week four.

We believe the unique mechanism of action for OTN, one nasal spray will help establish this product as an important treatment in the armamentarium of the eye care professionals.

Please turn to slide 24.

This slide illustrates a summary of adverse events in the onset to study.

Although we see a higher number of subjects in the treatment group experienced an adverse event. These events are primarily driven by the most common adverse event of sneezing.

There were no serious adverse events related to the study drug.

There were a similar number of ocular adverse events across all treatment groups.

The number of subjects with treatment emergent adverse events, leading could this continuation across all treatment groups was less than 3% any treatment group.

Treatment related adverse events, leading to study discontinuation that were related to study drug are less than or equal to 2% in both of the treatment groups.

Please turn to slide 25.

The most common adverse event with sneezing, followed by call nasal one throat irritation were reported in less than 15% of subjects in each dose group. This is consistent with the data from the onset one clinical trial with no newly identified safety signal.

Greater than 99% of events were considered mild importantly, because oh seal one nasal spray spares. The ocular surface. There were no events of burning are staying on the ocular surface. There were no no reports of serious adverse events related to nasal spray administration.

Please turn to slide number 26.

This slide summarizes data collected from each administration from the nasal spray patient administration diary.

In agreement with the adverse event data the most common adverse events experienced in the treatment group was sneezing, which was mild in severity in more than 99% of subjects.

Approximately 50% of all nasal spray administration were associated with sneezing.

The majority of subjects experience zero to two sneezes at administrations, where sneezing was noted sneezing was transient where the majority of sneeze occurring within the first minute following administration.

Please turn to slide 27.

As you will see here since August 2018, we have enrolled her started four clinical studies that encompass the Oh steel one dry eye disease clinical development program.

In January we released the results from the Mystic study investigating 84 days of twice daily dosing of OTO, one nasal spray.

Oyster points US clinical development program consist of the then bioavailability study as well as the onset lawn and onset two studies.

With these positive results from the onset to study we're on track to submitted an NDA application to the FDA in the second half of 2020.

We believe that the unique mechanism of action for owes tier one nasal spray will help establish this product as an important treatment for the eye care professionals.

Please turn to slide 28.

Dry eye disease is a chronic progressive disorder of the ocular surface characterized by a loss of tear film homeostasis.

This loss of homeostasis, resulting in increased evaporation and or decrease pure volume over the over time ultimately leads to irritation inflammation and damage to the okcular surface dry eye disease that complex and multifactorial disease that is difficult to treat effectively.

The novel mechanism of action of Osteo, one nasal spray stimulates the trigeminal parasympathetic pathway to produce natural tear film using the corner GIC receptor agonist for Rana Clint.

Please turn to slide 29.

Currently there is no substitute for the Bodys own natural tear film natural tear film consist of a complex mixture of thousands of compounds with beneficial components, including growth factors anti inflammatory compounds lubricating at hydrating components and is inherently anti microbial in nature.

Oh seal one provides therapy to the ocular surface that we believe will provide an early and sustain symptomatic relief, while treating the underlying disruption of tier film homeostasis.

Now I'd like to turn the call over to Oyster points, Chief Commercial Officer, Johnston's Urenco John Please go ahead.

Thank you Jeff Please turn to slide 30.

There was a significant unmet need in the treatment of dry eye disease.

Just in the U.S. alone over.

Pretty million adults are acted.

18 million less than half of these adults have been diagnosed and only 2 million are currently treated with a therapeutic over 7 million people try the currently available therapeutic options.

The majority of current treatments target the inflammatory component of try and take some time to see a therapeutic effect.

In addition, many of these options are I dropped which may have tolerability issues that can lead to poor compliance.

Please turn to slide 31.

Let's take a look at our commercial commercialization plan in anticipation that FDA approval and let's see alone. We are planning to launch I don't see a one in Q4 2021.

Commercial strategy focuses on three key areas.

Direct promotion to eye care professionals.

Educating both prescribers and patients and enabling instant access to this important therapy for dry eye disease.

We plan to hire a competitively size specialty sales force of between 150, and 200 reps, we believe we'll be able to target greater than 80% of the dry eye disease, Prescriber base, which includes optometrists and ophthalmologists.

We believe the Salesforce of this size will also be able to support the commercialization of additional eckler therapies in the future.

The therapeutic try at market has historically been quite responsive to direct to consumer promotion education.

We will invest an extensive education and focused marketing campaigns to both guy care community and to patients leveraging our novel Emo way and then it'll spray.

Third very important pillar of our commercial strategy focuses on enabling patient access to oversee a one.

We plan on contracting for broad payer coverage, which will allow for comprehensive pharmacy distribution of we'll see a wise.

We also plan and providing mission support services throughout the patient access and reimbursement process.

Outside North America, we will consider partnerships for international commercialization.

Please turn to slide 32.

We believe that with our data and the novel approach to treating dry eye disease, Oh see a one nasal spray has a very compelling therapeutic profile.

A convenient be I'd dosing delivered in a preservative free nasal spray.

A novel them away that stimulates the bodys own ability to produce natural tiers and restore to your thumb homeostasis.

Demonstrated in multiple clinical trials to rapidly improve the signs and symptoms of dry eye disease.

Improvement into your production was demonstrated in the majority and abroad population of dry eye patients.

And as always see a ones novel route of administration spares. The occupants surface. There was no okcular burning or staying in the most common side effect was transients sneezing.

I will now turn over the call to the operator to open the line for questions.

As a reminder, you have any questions at this time. Please press star in the number one and you touched on telephone. If your question has been answered that he wants to move yourself from the Q.

The best compound key.

My first question comes from the line on Tyler's Endearingly piping and moving your line is open.

Hey, guys. Good good morning, and congratulations to the positive data set and being the first company to hit both signs and symptoms two pivotal studies I guess since you guys have had a lot more time to analyze this data and the totality of the dataset than we have you just put the demand.

The two to response into context with the already approved agents overstay systems Hydro, perhaps both on the Schirmer score and eye Dryness and then also maybe just touch on onset of action as well.

Yes, great. Thanks, Tyler and good morning.

I would say one one way to look at this study is.

We alluded to earlier in the slides. This study really addresses a broad population of patients and because of that baseline characteristic of eye dryness score and the protocol, allowing patients from zero to 100 enter this study we really think that.

This trial consist of mild moderate severe patients and we did not enrich the study to just enrolled the moderate to severe dry eye population. So.

I think the important thing to take away is that we see consistent and reproducible results.

From the onset one and onset two trials, we don't see a difference in the patient populations between the more severe patients and the more mild patients. So we really have strives to try and design our clinical trials to have a real world applicability and enroll a population of patients that's more.

Ken to those they're going to walk through the clinic on a daily basis. We think this will also also translate into.

Real World outcomes, there will be similar to our clinical trial. So we see early increase and tear film production.

With as you see there statistically significant improvements as compared to control and on the eye dryness symptom side, we see in a statistically significant outcome at week four but I think what's most impressive as if you look at slide 16, and you see that progression from week, one two week to week four.

Where we see a continued improvement overtime with this product.

Great Thanks, Joe and John do.

Hopeful overview on commercialization strategy, but I guess my second question is just.

Thought on commercial current thoughts and commercialization versus engaging someone would book.

Infrastructure liquidity Bill.

Yes, I think its Tyler we do plan to hire in house, our specialty sales force.

We feel that would be.

Supportive of of the data that we want to bring to the eye care professionals the prescribers.

And also if good support other commercialization efforts for other ocular therapies that we will bring in the future. So we know where the prescribers are based on the history of Zohydro, Restasis and others and and we will have a competitively size salesforce that's in house to be able to target.

Optometry and ophthalmology.

Helpful. Thank you.

HM.

Thank you know next question comes in the line can catch 20 with Cowen and company. Your line is open.

Hey, guys my congratulations as well looks fantastic just wanted to ask John in terms of commercialization Kings talk about the current treatment success and failure rate.

He said 7 million a try but just to give folks in us some sense of.

The success or failure that decides on Restasis have and then also wondering in terms of potentially at some point combination use any any reason why there would be limitations and using it together restasis has yet to go generic but if it does it would I would imagine it would be cheap and yours would be Brent maybe there would be the ability to use it together.

Just wanted to get your thoughts and then lastly.

The FDA has used different criteria different endpoints for both restasis inside Dre and there's been some moving around just the evolution of thought at the FDA in terms of the different endpoints vis-a-vis the ones that you use thank you.

Great Great. Thank you for your question in regards to the number of patients that have tried the current therapeutic options.

As we know that the current therapeutic options tend to target the inflammatory component of dry and do it takes some time to work.

You know.

Some some as long as three to six months. So you can imagine a lot of patients have tried on the given up on some of those therapies.

Since the 7 million over time.

That that group that number has built.

As well because were sparing yonkers surface to current therapeutic options, our eye drops and they do cost some burning in stinging inpatient do give up on them due to those side effects as well. So we do feel that there is a group of patients that are looking for other options and I think even from a payer pursue.

Back to whether commercial and Medicare there have been many patients that have tried and failed so even if a generic restasis does come onto the market you know and we would have to step through a generic restasis. There are many patients that would qualify to move right into OCIO, one as a therapeutic option.

I'll, let Jeff comments on some of the F.D.A. questions that you had there on endpoints.

Yes, thanks, Ken So I think.

When it comes to combination therapy.

Do you think one of the benefits of this product because of the novel mechanism of action is that it will allow the clinicians both optimum optometrists and ophthalmologists to really think about how they want to use that in the entire scope of treatment options that they have at their disposal and so.

So I do think that they will think about how to use this product with other therapies I think they will think about how to use this product with other devices that may exist on the market, but because this product is novel and basically the way in which we're delivering treatment, which I think is often lost that we're not putting anything on to the.

Ocular surface, we're stimulating tear film and so to be able to get these results by stimulating natural tear film and putting a.

Healthy components onto the ocular surface, we think will be important in the context of all of the other dry eye treatments that are out there from an endpoint perspective, you know I do think that the FDA.

Has been open to a lot of different endpoints, what I would say here is when we began this development program, we have consistently using the same endpoint over and over again.

We think that I dryness score.

In that it's been used for the approval of other products was an important symptom.

Endpoint and then on the Schirmer score I think one other things that is also important here is.

There really are no other products out there that give the clinician a repeatedly and reproducible.

Assessment of a biomarker to see how patients are doing but also to see.

How patients will do in a schirmer score is a very simple test every ophthalmologists and optometrists knows how to deliver that test and we feel we're going to be able to provide.

Clinical data to the optometry and ophthalmology community that we will be predictive based on this biomarker, but these are endpoints that are clinically meaningful and so if you look across the landscape of endpoints that can be used in dry eye trials.

I think these are really important which is how much tier film or we're putting on the ocular surface and then what's the impact to the patient from a symptomatic perspective.

Great. Thanks, so much congratulations again.

Thank you.

Our next question comes on the line up Omnicom Ramaala JP Morgan Your line is helpful.

Hey, guys and this is test on the call. This morning, earning power on a congrats as well from us on their results.

Maybe I first line Oh, we think data you you saw here on yes are you going to be filing. Both those days are you are you thinking about this filing the higher downish. How are you thinking about that and then I have a follow up.

Sure I think that's a great question.

You know with 48 hours or so of being able to digest. The data there's still a lot of data that we need to assess and I think we'll be able to start to look got.

Subset analyses and some of the other planned analyses that are not a part of the topline data. In addition, as we compile our integrated summary of efficacy from both the onset one in onset to program I do think that that combine dataset will also allow us to see things that maybe.

Each of the two studies themselves are not able to.

Illustrate and so.

As we learn more we'll be able to give some more guidance, but I think as of today.

Just based on the onset to study, we do see clinically meaningful improvements in symptom score and we do see a slightly higher improvement in those schirmer scores, but.

I don't think that we're ready to make a final decision as of today.

Okay. That's helpful. And then maybe you may have touched on this I missed on for Jeff I just.

Any other color you wish to playing out I'm sort of the higher perceive outperformance that restocking.

And I'm sorry Q.

Relative to kind of kind of maybe we work we were thinking coming into their trialing and how should we is youre talking about that in the context on kind of the baseline patients enrolled her on T. can.

Yeah, No that's a great question so.

We do see a higher.

Score across the board for that placebo group, whether beyond Schirmer score whether it be.

Symptoms.

And as compared to our on site. One study. So I think what this does illustrate is a healthier patient population than we had been rolled before.

I think if you were look at the numbers you see about 175 patients of that 758 population are actually below 40 on it I dryness at the time that they enter the study. So these are not patients that would have been entered into other dry eye clinical trials and we see a consistent effect across.

All of these groups, whether they're on the milder and to the spectrum or the more severe end to the spectrum. So.

One of the important things.

As a takeaway from this study is I think it's a real world study.

For all the reasons that I listed in that first a set of slides and it's going to be very translatable to everyday practice.

These are patients that walk through the door are they in some cases have a milder form of the disease and we really think that because of the novel mechanism of action of Bosio. One this product really is applicable to the patients all across the spectrum. So when we look at the data I think it's even more impressive, especially on the symptom score.

To be able to see this type of an effect in a patient population that's much more healthy than we've seen in the past.

Great. Thanks, so much time, taking a question.

Thanks.

Thank you on our next question comes in the line of patches Donlins all with lifestyle capital. Your line is open.

Hey, congrats on the data and thanks for taking my questions and apologies in advance if theres some redundancy Eric's I actually got disconnected at the beginning of the cure.

So on the traditional symptoms endpoint.

Or are you guys its significance there and this wasn't a consistent with the C endpoint or.

Does it.

Hoping for a little color on the relative importance symptoms and obviously the versus D and kind of how those early regulatory discussions have been shaping up as to.

Whether this aspect that affects labeling and I guess beyond that were there any study design differences that accounted for these results just given that that will I know you as measured at week three versus week or an honest that too.

And then I've a follow up as well.

Sure.

So I think.

The best way to answer overall, and it's common theme that youve heard throughout the study is patient population is healthier than we've been rolled in the past overall.

Certainly think that that probably had some thing to do with.

The results that we've seen both in the clinic as well as in the controlled adverse environment was unfortunate.

That we.

Had an impact to the controlled adverse environment due to the cobot 19 pandemic, but we do think that and feel that vary.

Lucky that we were able to finishing enrollment with what we think overall is minimal impact.

To the study and so when you look at the the Ssi data you will see Theres a significant impact to the patient population that was able to be evaluated that being said, what we were hoping for in the CE is really to illustrates just how powerful this drug is.

In multiple environments and when you look at the data, although we didnt hit that.

Plain estimate if you look at the totality of the data in a controlled adverse environment, we do see that there's a protective benefit with that especially that high dose group versus.

Control.

In the context of.

The real world and feedback that we have from our advisors.

They look at the controlled adverse environment does.

More of an interesting endpoint and they really put more weight into that clinic eye dryness, because that's really what patients are going to experience on a on a daily basis. So we wouldn't expect.

The clinicians to be putting their clinical patients into a CE, but these are the types of environments that people and encounter when they're on planes when they're in forced hot air environment. So I think it's between the healthier population and the loss of sample size from the Corona.

This impact we saw a directional benefit certainly not as big as what we saw and beyond that one.

Study.

But having the powered to show those very small.

Improvements, we just did not have in this study unfortunately.

Got it that's helpful. And then where you guys able to collect any data then onset to on patient satisfaction kind of outside of yes or to understand that more qualitatively how patients are using the product profile and kind of overall satisfaction with yours and protect.

People are they perhaps preferences for an internet or versus an eye drop.

Yeah.

Yeah. Thanks, that's a great question. So we didnt formally collect data in onset to although we have market research data that does.

Indicate that patients that are currently on branded therapeutic products for dry eye disease.

Would consider switching over to the nasal spray.

About 90% of surveyed patient said that if the product is available today. They would take the nasal spray I think the way that we look at the product is.

There are patients out there in the world that certainly 100% for patients will not like to take a nasal spray, but we do think that the product profile is going to be well accepted if you look at our study design, you'll see patients did not dropout or the study due to.

Adverse events associated with the nasal spray at any appreciable rate and we see in our market research that as compared to eyedrops.

The nasal spray route of administration is preferred by most patients and so I think we all know the patient compliance issues that come along with delivering something to the okcular surface.

There are many patients that just can't deliver the drug adequately to the ocular surface and there's also patient populations out there such as patients that were contact lenses, where this becomes problematic and we think that this nasal route of administration bypass as many of those challenges.

Great. Thank you and congrats again.

Thank you.

And once again, ladies and gentlemen, you see I've a question at this time, Please press star and the number one.

I'm not showing any further questions I'll now turn the call back over to management for closing remarks.

Thank you operator.

I'd like to thank everybody for joining the call today, our original vision for owes deal one nasal spray to treat the signs and symptoms of dry eye disease was to develop a transformative treatment to address the large unmet medical need for patients by our hypothesis of restoring tier film homeostasis in that.

Actual to your production.

We've produced positive efficacy results on multiple endpoint to signs and symptoms in several randomized controlled trials, we designed our trials to address a broader real world population, which we believe will allow I practitioners to translate to clinical results into practice and strategize how to use this product in their practice.

We feel that this is one of the reasons that patients do not often persist with current dry eye therapies as the benefits seen in the clinical trials do not translate to the broader dry eye population I'd like to thank everyone for joining us today, and I wish and hope that your and your family stay safe and healthy.

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Ladies and gentlemen that does conclude the program you may now disconnect.

Appreciate that.

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