Q3 2022 Aldeyra Therapeutics Inc Earnings Call

[music].

Yeah.

Ladies and gentlemen, thank you for standing by and welcome to the Alterra Therapeutics third quarter 2022 financial results conference call at.

This time all participants are in listen only mode. After the speaker's presentation, there will be a question and answer.

<unk>.

I would now like to hand over the conference to the company's interim Chief Financial Officer, Mr. Bruce Greenberg. Please go ahead Sir.

Good morning, everyone with me today is Dr. Todd Brady, our president and Chief Executive Officer.

This morning, we issued a press release reporting our financial results for the quarter ended September 32022, and recent corporate highlights a.

A copy of the press release is available on the investors and media section of our website at Www Dot El Dorado Dotcom.

Please note that this morning's conference call contains forward looking statements regarding future events and the future performance about there are forward looking.

Statements include but are not limited to statements regarding submission of potential new drug applications potential commercialization the anticipated timing of results from our clinical trials, our projected cash runway.

Possibly or assumed future results of operations expenses and financial position.

And potential growth opportunities.

These statements are based on the information available to us today and reflect our current views concerning future events. They are based on assumptions and subject to risks and uncertainties, including the development clinical regulatory plans or expectations for <unk> product candidates is systems based approaches.

The rest of the results from clinical trials or portions of clinical trials may not accurately predict the results or future trials for the same or different indications in Algeria is continuing review and quality control analysis of clinical data.

Yes.

As a result of the COVID-19, pandemic clinical site availability staffing and patient recruitment have been negatively affected and the time lines to complete our trials may be delayed out there assumes no obligation to update these statements as circumstances change future events future events and actual results could differ materially from those projected in our forward looking statements.

Including the current and potential future impact of the COVID-19 pandemic on our business results of operations and financial position.

Okay.

Additional information concerning factors that could cause results to differ materially from our forward looking statements are described in greater detail in our press release issued this morning and in our filings with the SEC.

I will now turn the call over to Dr. Brady.

Okay.

Thank you Bruce and good morning, everyone.

Today I'd like to share with you the progress we've made an.

And advancing our lead pre commercial product candidates.

<unk> lab, and ATX 21, 91 towards regulatory approval.

Individually these products have the potential to provide us with unique revenue streams, while together they represent an opportunity to build a formidable ocular franchise.

Encompassing both large and rare retinal diseases that are significantly underserved by currently available treatments.

Our success to date in developing where proxy lap an AVX 21, 91, and the commercial potential of both product candidates.

Serve as evidence of our <unk> position as a leader in the development of systems based therapies for diseases.

Characterized by inflammation.

Leading off with a proxy lap in September we had a successful pre NDA meeting with the U S food and drug administration.

Gaining alignment on the key aspects of the planned NDA submission.

In the fourth quarter of 2022, we plan to submit what we believe will be the most comprehensive regulatory package ever.

For a dry eye disease drug candidate.

With the results based on five adequate and well controlled completed clinical trials, we intend to submit the NDA with data.

For ocular dryness symptom score.

Ocular redness.

Jeremy our cast and schirmer test greater than or equal to 10 millimeter responder analysis.

The NDA efficacy package is expected to include activity ranging from within minutes of drug administration to up to 12 weeks of treatment.

Crossover and parallel group clinical trial designs.

And assessment in dry eye Chamber challenge and natural environment settings.

The NDA package will also include up to 12 months of approximately <unk> safety data.

As a reminder, <unk> has been studied in more than 2000 patients with no observed clinically significant safety concerns.

With the most commonly reported adverse events being mild and transient instillation site irritation.

Complementing our dry eye disease program. We're also advancing our proxy lab toward a potential supplemental NDA submission in allergic conjunctivitis.

Results from the invigorate, two allergen chamber trial, which could represent our final clinical trial over approximately <unk> in allergic conjunctivitis.

Our expected in 2023.

In October .

However, the previously completed phase III Invigorate trial was the subject of a presentation. The American Academy of Optometry 2022 annual meeting.

Moving to our clinical development programs targeting diseases in the back of the eye of several planned milestones are approaching for AVX 21 91 hour.

Our pre commercial product candidate for rare retinal disease.

AVX 21, 91, as the first sterile non compounded formulation of methotrexate designed to meet the unique requirements of <unk> administration.

It is intended to be vitreous compatible and optimized for excipient composition viscosity density Tonicity ph active ingredient concentration and volume of administration.

Importantly, the volume of administration is less than that have compounded methotrexate potentially resulting in an improved safety profile.

Although compounded methotrexate is injected into the vitreous today.

<unk> 21, 91, if approved would represent the first GMP manufactured methotrexate drug product for <unk> administration.

Our AVX 21, 91 platform is targeting three indications all of which have received U S. FDA orphan drug designation.

Primary Vitreoretinal lymphoma is a rare aggressive and fatal cancer that is diagnosed in approximately 3% to 600 patients in the United States States per year.

Proliferative vitriol retinopathy or PBR, the sight threatening condition and a leading cause of failure of retinol re attachment surgery that affects approximately 4000 patients in the U S per year.

And retinitis Pigmentosa.

Group of rare genetic eye diseases characterized by cell death and loss of vision.

Affecting an estimated 82000 individuals in the United States and approximately one in 4000 people.

Worldwide.

We have scheduled a pre NDA meeting with the FDA in the fourth quarter of 2022 to discuss AVX 21, 91 for the treatment of primary Vitreoretinal lymphoma.

Pending the results of the pre NDA meeting NDA submission may occur as soon as the end of 2022.

For <unk> this quarter, we announced that AVX 21, 91 met the primary endpoint in part one of the Phase III Guard trial.

<unk> 21, 91 was statistically superior to historical control for the prevention of retinal detachment due to <unk> over six months.

With a P value of 0.0 to four.

Although not statistically powered for secondary or exploratory endpoints. The results of the guard trial demonstrated numerical superiority of <unk> 21, 91 over routine surgical care and reducing every SaaS of dichotomous endpoint of ocular disease.

With an overall P value of 0.047.

The most common adverse event associated with AVX 21, 91 treatment was punctate keratitis.

Well known side effect of intra vitriol methotrexate that was most commonly mild in severity.

Across all other treatment emergent adverse events occurring in at least 10% of patients.

And either treatment arm relative to patients treated with routine surgical care AVX 21, 91 treated patients had numerically fewer side effects with an overall P value of 0.000 too.

We plan to discuss the completion of clinical development for PBR in a type C meeting with the FDA in the first half of 2023.

We also expect to announce phase III clinical trial results of AVX 21, 91 in retinitis Pigmentosa in the first half of next year.

<unk> patients are expected to be enrolled in the trial with half receiving monthly <unk> injections and the other half receiving twice monthly <unk> injections.

Over a period of three months.

Turning to <unk> 629, our oral RASK modulator platform targeting systemic inflammatory disease, we remain on track to report top line results of this year.

From a phase II clinical trial in acute alcoholic hepatitis.

In addition by year end, we also plan to initiate phase II clinical trials in Sjogren Larsson syndrome.

And minimal change disease.

Topline results of the phase II clinical trial in chronic cough are anticipated in the first half.

Of 2023.

Now I'll turn the call over to Bruce for the financial review.

Bruce.

Thanks Todd.

Cash cash equivalents in marketable securities.

As of September 32020 to $185 3 million.

Based on our current operating plan, we believe that existing cash cash equivalents in marketable securities will be sufficient to fund currently projected operating expenses through the end of 2023, including NDA submissions and initial commercialization of both for <unk> and <unk> 21, 91, if approved and continued.

Early and late stage development of <unk> product candidates and ocular and systemic immune mediated diseases.

Net loss for the three months ended September 32022 was $14 6 million or <unk> 25 per share compared with a net loss of $15 8 million or $27 27 per share for the comparable period of 2021.

Losses have primarily resulted from the cost of clinical trials and research and development programs as well as from general and administrative expenses.

Research and development expenses for the three months ended September 32022 were $11 5 million compared with $12 9 million for the same period in 2021.

The decrease of $1 4 million is primarily related to a decrease in external clinical development costs offset by increases in our external preclinical development costs drug product manufacturing expenditures personnel cost and consulting expenditures.

Yeah.

General and administrative expenses for the three months ended September 32022 were $3 2 million compared with $2 5 million for the same period in 2021.

The increase of <unk> 7 million was primarily related to higher personnel costs and consulting expenditures.

Total operating expenses for the three months ended September 32022 were $14 8 million compared with total operating expenses of $15 4 million for the same period in 2021.

Now, let me turn the call back to Dr. Brady for closing remarks.

Thank you Bruce.

The remainder of 2022.

Are shaping up to be an exciting catalyst rich period for Aldara.

Mark by two planned NDA submissions and multiple data readouts with two late stage candidates in anterior ocular and rare retinal diseases, representing potential revenue streams in 2023.

And our clinical stage, RASK modulator platform and systemic immune mediated diseases.

There is pipeline represents an innovative opportunity to positively affect patient care and both large and rare diseases.

With that we'll be happy to take your questions operator.

Thank you.

I'd like to ask a question. Please press star followed by one on your telephone keypad.

Any reason you wouldn't actually makes that question. Please press star followed by two again to ask a question. Please press star followed by one as a reminder, if you are using a speaker phone. Please remember to pick up your handset before asking your question.

Our first question today comes from the line of Yigal local Marvin.

From Citi. Please go ahead. Your line is now open.

Hi, This is carly on for Yigal. Thank you so much for taking our questions.

Can you elaborate on what still needs to happen before submitting the <unk> NDA by the end of the year, which components of the filing still need to be completed and we're also curious if at any point you had considered a rolling NDA, our or was that not really an option with that division.

Hey.

Okay.

Good morning, <unk> and thanks for your question.

Our bias to what needs to be completed prior to the submission of the <unk> NDA is.

Very little.

That NDA submission process.

From our end is well underway, we are reiterating our guidance that that NDA will be submitted.

During this quarter.

A rolling NDA is typically reserved for.

At rare and or fatal diseases, where lack of therapy is.

Part of the unmet medical need I don't think that typically would apply for.

Dry eye disease, although I will say that dry eye disease is persistently disturbing.

And as a society I think we can do more to address diseases like dry eye disease, which arent necessarily fatal, but do affect tens of millions of people.

On a daily basis and are responsible for a significant amount of <unk>.

Economic costs as a result.

Okay got it that's helpful and then for the AVX six to nine data in acute alcoholic hepatitis later this year can.

Can you just talk about what you want to see there to establish proof of concept to continue the program.

Is this a situation where you sort of have a clearer idea of what is needed or do you need to see the data and then make an assessment after seeing it.

Well, we certainly want to see the data.

Before deciding what to do next.

Couple of comments about.

Alcoholic hepatitis is this.

<unk> is a disease, which really hasnt been addressed that.

That pharmacologically.

By the drug industry. The irony is it affects many millions of people and the unmet need is considerable.

There is no drug approved for alcoholic hepatitis in terms of RASK modulation that mechanism is particularly appropriate.

Two alcoholic hepatitis when we consume alcohol.

Alcohol is metabolized to Iraq, particularly acetaldehyde.

Which is reactive immunogenic, it's toxic pro inflammatory.

Our RASK modulator platform, including AVX six to nine.

In theory would reduce acetaldehyde.

Levels and thereby prevent some of the toxicity that we see following chronic.

Exposure to ethanol in terms of the trial itself, we're assessing both symptoms and signs after acute alcohol exposure.

Criteria for advancement typically involve.

Achievement of either a symptom or a side.

So that the drug can be studied in a larger.

Trial, a variety of trial designs that are under consideration, but as you point out currently I think we need to see the data when you speak with the key opinion leaders in this space.

We need to gauge the level of excitement for moving forward given the data and then make a decision and we will update the street accordingly, along those lines.

Okay, great. Thank you for taking our questions.

My pleasure.

Thank you.

The next question today comes from the line of Marc Goodman from SBB Securities. Please go ahead. Your line is now open.

Todd how are you thinking about crux of laptops in the commercialization of the product and just the market that it would be entering and how that market's evolved over the past year. We've had some new products that have entered over the past couple of years and just your thoughts on what.

The differentiation.

What those products did with those products didn't do thanks.

Mark that's an excellent quest.

A question and as I like to say on these calls consistent with your experience in this.

Face.

Something we've been thinking about a lot recently in terms of commercialization of our proxy lap and positioning of our proxy lap is how the dry eye landscape is changing.

On one hand, dry eye remains a tremendous unmet medical need.

Literally affecting tens of millions of people in the United States alone.

<unk> said for many years and continue to believe that the current therapeutic options for dry disease or <unk>.

Inadequate as perceived by both healthcare providers and patients.

As we look towards 2023.

We have a variety of potential new entrants.

In the dry disease space.

We have a novel oil like product for my <unk> gland dysfunction, whereas an NDA has been submitted we have yet another version of cyclosporin, where an NDA has been submitted.

We have an approach to treat.

<unk> on the eyelid.

We have a recently approved.

Product fits a nasal spray for the treatment of dry eye disease.

Amongst all of those products. However, all Dara is the only novel drug and by novel drug I mean, new chemical entity.

New target and most importantly.

<unk> Eyedrops, all Dara as the only company that has consistently demonstrated activity.

On an acute basis that is as I said in my prepared comments.

Within minutes.

So I think.

<unk> is well positioned.

Moving into the market space that.

I just described and what.

One of the things you can expect to see from Alterra in terms of our commercialization and positioning.

Texas on that rapid onset.

Especially as it relates to symptomatic improvement, which correlates not only.

With with symptoms, particularly in our chamber trials, but also.

The 10 millimeter responder analysis in Schirmer test.

Another indicator of symptomatic improvement.

Thank you.

The next question today comes from the line of Justin Kim from Oppenheimer. Please go ahead. Your line is now open.

Hi, good morning, Kelvin and team thanks for taking the questions maybe just two from us.

You think about the upcoming pre NDA meeting for PCL, what sort of the broad topics in <unk> outcome.

We're looking to cover.

That agreement.

And then secondly, just as a follow up to a prior question was curious whether it's a safety study for <unk> has yet been met from a requirement standpoint, and sort of how that has been tracking.

Hi, Justin.

<unk>.

I think typically for pre NDA meetings.

Main objective is to.

Avoid any sort of.

Misunderstanding.

Between the sponsor and the agency in terms of what is required for submission in particular efficacy and safety data.

Obviously those questions about the adequacy of the package in terms of efficacy and safety are first and foremost.

Other questions often involve what can we submit at the time of the submission versus what can we submit at the 120 day update which occurs post submission and typically for.

And the FDA broadly across all divisions will accept.

Certain things at the time of the first submission and other things at the time of the 120 update and Thats something that we would intend to clarify as we did with the <unk> App pre NDA meeting.

Given that methotrexate is the standard of care.

In ocular lymphoma.

Given our discussions with the agency at previously on ocular lymphoma, the material aspects of which we have already disclosed.

I don't expect a vigorous discussion on the utility of methotrexate to treat lymphoma, rather I think the pre NDA meeting will be focused on process and structure and to some extent that content.

Your second question the safety trial for <unk>. Thank you for asking as I've said before on these calls.

Investors and analysts often forget that it's not just about efficacy.

For NDA submission, it's also about safety and.

CMC.

I think in this case regarding the safety trial.

We're very well positioned.

The FDA guidance in dry eye disease is very clear as it relates to safety trials.

300 drug treated subjects must complete six weeks of treatment.

And approximately 100 drug treated subjects must complete 12 months of treatment.

Our safety trial is.

Moving along nicely I think it's safe to assume.

At the.

That trial is practically complete otherwise we wouldn't be guiding our submission this.

This quarter all in all I think our package is robust I think it's in excellent shape and I look forward to the submission.

Okay.

Okay. Thanks, so much and looking forward to the update later this year.

Thank you.

As a reminder, if you would like to ask a question. Please press star followed by one on your telephone keypad.

The next question today comes from the line of Kelly <unk> from Jefferies. Please go ahead. Your line is now open.

Hi, This is strong on the floor as Kelly thanks for taking a couple of questions.

I have a question on the new candidates for <unk> modulation.

Give us more color on this new candidate and what are the improvements upon with <unk> lab in six to nine.

What are the indications that you will pursue thank you.

Hi, Sean good morning, and thanks for asking about our systemic platform.

Like Austin, we get lots of questions about for proxy lap and lots of questions about AVX.

191, because those two.

Compounds are the subjects of NDA that are near term.

Potential near term revenue generators for our company.

But really the core of our development pipeline as RASK modulation as it relates to retinal and systemic disease.

As you know <unk> nine which is at the vanguard of that.

Effort is.

Involved in clinical trials for alcoholic hepatitis and in chronic cough.

Soon sjogren Larsson syndrome and.

Soon minimal change disease, we hope.

Other related molecules that are RASK modulators, and we have a whole platform of brass modulators.

We'll be in the clinic and we hope as soon as next year or soon thereafter for the treatment of other.

Autoimmune and inflammatory diseases, where RASK are elevated I think what's so interesting about out there.

Is that we seem to be the leader in RASK modulation that we are aware no. Other company is working on modulating rasp RASK represents a novel pharmacological target.

He is one of if not the only.

Pharmaceutical target in biotech biotech today that is not a protein.

RASK for small molecules, we aim to affect not just one but many different small molecules that comprise the family of RASK.

RASK are broadly inflammatory.

And are involved in a large number of diseases. So this is a true novel platform with novel drugs novel targets and really a novel pharmacology that has broad implications for not only a variety of diseases with.

Unmet medical need, but also our understanding of how inflammation.

Occurs in evolves.

Within the body potentially leading to new insights.

Further on down the road.

Thank you very much.

Thanks Scott.

Thank you.

The next question today comes from the line of Yale Jen from Laidlaw and co. Please go ahead. Your line is now open.

Good morning, and thanks for taking the questions.

Follow up for all of the earlier question regarding <unk> in acute alcoholic alcoholic hepatitis.

Regarding the.

Endpoints and.

What do you what sort of anticipation you'll may have on this.

These data release.

Hi, Good morning, Alan Thanks for the question.

Well as I mentioned, we have a variety of endpoints associated with symptoms that as Hell sub.

Subjects feel.

After consuming.

What I would characterize as a large amount of alcohol.

As well as signs.

The scientists would include objective measures of.

And Toxication.

And metabolic profiling I mentioned acetaldehyde, obviously that is one.

The cytokines and <unk>.

There are a variety of.

Tests that can be performed on individuals.

After alcohol administration, we're familiar with some of them appropriate reception tests Romberg test how many steps can you walk in a straight line how long can you balance on one foot and so forth. So I think that we'll be able to present the street with a very interesting collection.

<unk>.

Endpoints.

We'll have to see exactly how the drug performs in an acute setting obviously in the real world No one.

Makes up one day and decides to drink a lot of alcohol in endeavour drinks again I think.

Most individuals that suffer from I'll call. It hepatitis had been shrinking for many many years.

And how the drug performs in those settings, I think would need to be assessed.

And different types of clinical trials.

Okay great.

Very helpful and maybe just one more quick questions.

I recall that.

Children allow some disease.

You have wait back has a topical drug.

And showed very promising outcomes.

And what do you think that impact on the current six to nine developments.

Kinda indication, which you're going to start early next year later this year.

Right yes.

Earlier, you've been around long enough to remember our previous clinical developments in Sjogren Larsson syndrome.

For those of you that don't know.

Many many years ago, a approx of App was developed not only as an eye drop but also as a dermatologic formulation.

Does that we applied in a couple of clinical trials to patients with Sjogren Larsson syndrome, Sjogren Larsson syndrome is an interesting condition as it relates to RASK, because it's an inborn error metabolism.

We're rasp are not sufficiently metabolized.

Metabolized, resulting in high level, particularly fatty aldehydes.

As a result patients suffer from a severe skin disease called <unk>, which is a fancy way of saying scaly.

She has claimed.

Ken.

Additionally, that patients suffer from neurological compromise spasticity cognitive deficits and so forth that increases gradually over time.

With <unk>, we saw activity in the skin at the same time, we began generating the positive data in dry eye disease, and allergic conjunctivitis and decided to advance or approximate app as a molecule.

Dry eye disease, and allergic conjunctivitis, and then move the treatment of Sjogren Larsson syndrome to a systemic treatment.

Why systemic well a systemic treatment could in theory affect both the skin and the neurologic compromised characteristics.

<unk> Larsson syndrome.

As a result, we are thrilled with the potential of <unk> 69, which is administered orally.

69 by binding and sequestering the fatty aldehydes.

<unk> make a difference broadly.

Sjogren Larsson syndrome.

Patients. This trial will initially assess both skin and neurological outcomes.

Particularly as they relate to a variety of biomarkers, including the Saudi aldehydes and fatty alcohols in other markers of Sjogren Larsson syndrome, Neurologically, which have been fairly well characterized in the past for a variety of reasons.

Not only that proof of concept evidenced by the approximate <unk>.

We're excited about <unk>, the potential and sugar Larsson syndrome.

Okay, great. Thanks, a lot.

That's all in the all the progress.

Thank you Yale.

Thank you.

The next question today comes from the line of Catherine Novak from Jones Research. Please go ahead. Your line is now open.

Hi, Martin Todd Thanks for taking my questions.

Curious about any further clarity on when in 2023, we can expect invigorate two data I understand there's a seasonality component when conducting this trial and then once you have the data package in hand, what what are the steps in terms of.

What will you be able to file.

Catherine and good morning.

Youre, absolutely right about the seasonality component.

In allergic conjunctivitis.

Allergic conjunctivitis is a very common disease, it probably affects something like one third of the world.

Typically we think of allergy being caused by histamine also anti Histamines, which we can now buy over the counter.

Don't work and about a third of the patients.

So there is considerable unmet need that's the good news the bad news from a clinical trial standpoint is you can't test and allergic conjunctivitis during pollen season, and the reason for that is if theres pollen in the air that.

That will confound, the pollen were using and the allergen chamber, So allergen chamber trials need to be performed mostly during the winter.

When there is no policy no ambient pollen.

A hint to the answer to your question is.

<unk> expect that invigorate two will be enrolling significantly.

After the end of this upcoming winter that is as we enter spring and summer.

Our expectation is that enrollment and invigorate two would be largely complete which probably tells you something about the timing of the data for invigorate too as I mentioned in my prepared comments allergic conjunctivitis would be the subject of a supplemental NDA supplemental <unk>.

<unk> are filed or submitted after the.

First NDA is approved.

Given that we're submitting.

For dry eye disease and this quarter.

And a standard FDA review, one could expect a supplemental NDA going in for allergic conjunctivitis towards the end of.

Of next year.

Got it that's very helpful.

And then just one final question on six to nine.

Curious, how youre thinking about prioritizing multiple development programs and then.

The alcoholic hepatitis data useful we're informing future indications in Shouldnt Morrison or mcd.

Okay.

Well.

Alcoholic hepatitis as I mentioned, it's interesting because the.

<unk> disease is largely the function of a RASK.

That we generate when we metabolized alcohol activity, either symptomatically or an assign an alcoholic hepatitis, which suggests to me at least target engagement.

It is important for every condition we're testing.

With 609 and soon to be testing with analogs of <unk>.

609.

A question about program prioritization is also interesting.

We have a little bit of embarrassment of riches.

As I mentioned previously are involved in a large number of dizzy.

Diseases characterized by inflammation most diseases are characterized.

By inflammation to some degree and so I think we as a biotech need to think carefully.

About.

Resources and.

And time constraints, when we're selecting indications our indication selection process from the very beginning.

Has it been systematic.

Because RASK modulation is a new approach a new pharmacology.

Quite keen to.

Establish exactly how these drugs are working what kinds of inflammatory diseases like optimally respond to rasp inhibition, our current programs and alcoholic hepatitis and SLS and minimal change disease, and chronic cough or an extension of that systematic.

<unk>.

To define.

Our our pharmacology and activities.

I would expect that will read out the data from.

Said trials, we'll make a decision about how to advance <unk> 69 in particular the good news is we have backup molecules at analogs and brothers and sisters of AVX 69 that will be able to allocate to other diseases, where we think.

The therapeutic index is sufficient sufficient for advancement.

Got it that's very helpful. Thanks, so much for taking my question.

Thanks Catherine.

Thank you.

The next question today comes from the line of Thomas Shrader BTG. Please go ahead. Your line is now open.

Hey, Good morning, Todd This is Tom on for Tom Tom.

So regarding the PV or could you provide some additional color on which patients will be considered low hanging fruit and what do you need to broaden its use and also is there like a subset of patients that are at high risk for their first surgery.

I saw and good morning.

DVR spans.

A.

Large range of potential patients and the guard trial, we enrolled two different types of patients one with recurrent retinal detachments.

So called Reg <unk> retinal detachments that more or less occur spontaneously. The first time. The other group of patients was so called open globe.

Injury patients.

Those patients.

That suffered trauma to the eye are at high risk for.

PBR, if theres, a retinal detachment associated with that trauma.

Okay.

Within the Reg Metagenesis detachment group.

Risk of PBR increases dramatically with the number of recurrent detachment there are other risk factors as well.

But in the guard trial, we essentially enrolled all comers.

In the <unk> group, where PBR was present at the data as we presented in card were compelling.

And the safety data from guard were particularly compelling those safety data will be highlighted.

Not only for <unk>, but also for the lymphoma.

NDA submission I think all at all.

The market for PBR is exciting there is no approved drug we have orphan designation, we have fast track designation it'll be interesting to see commercially how the drug is used.

Approved.

<unk> could be used in a broad array of patients even patients.

In theory that have had recurrent retinal detachments without PBR.

More or less as a preventative in fact, our orphan designation is for the prevention of PBR.

Eager to see how AVX 21, 91, if approved is adopted clinically.

With regard to PBR.

Great. Thanks for the color.

Thank you Simon.

Thank you.

There are no additional questions waiting at this time, so I'd like to pass the conference back over to Tom Brady for any closing remarks.

Thank you.

For your time this morning and as always.

We look forward to keeping you updated on our progress as we continue to endeavor to improve the lives of patients with.

With significant unmet medical need.

This concludes today's conference call. Thank you all for your participation you may now disconnect your lines.

Yeah.

Okay.

Okay.

Okay.

Sure.

Yes.

Yeah.

Yeah.

Yes.

Okay.

Okay.

Yes.

Yeah.

Good morning.

Great.

Okay.