Full Year 2020 Aldeyra Therapeutics Inc Earnings Call
Uh huh.
[music].
Good morning, and welcome to the Aldara Therapeutics full year 'twenty 'twenty financial results conference call. After the Speakers' remarks, there will be a question and answer session. If you'd like to ask a question during that time simply price Star then the number one on your telephone keypad to withdraw your question press the pound key at this time.
I would like to turn the call over to Mr. Joshua Reed the company's Chief Financial Officer. Please go ahead Sir.
Thank you and good morning, everyone on the call with me is Dr. Todd Brady, President and Chief Executive Officer Dr.
Dr. Todd Brady will begin with an overview of our recent highlights and expected upcoming clinical milestones.
I will discuss our full year 2020 financial results and then we'll take your questions.
Please note that this morning's conference call contains forward looking statements regarding future events and the future performance of Aldara.
Forward looking statements include statements regarding the timing of planned clinical trial initiations of there is possible or assumed future results of operations expenses and financial position business strategies, and plans research development and commercial plans or expectations trends market sizing competitive position.
Industry environment and potential growth opportunities among other things.
These statements are based upon the information available to the company today.
As a result of the COVID-19, pandemic clinical site availability staffing and patient recruitment have been negatively affected and the timeline to complete our clinical trials may be delayed.
Are there assumes no obligation to update these statements as circumstances change.
<unk> events and actual results could differ materially from those projected in the company's forward looking statements, including the current and potential future impact of the COVID-19 pandemic on our business results of operations and financial position.
Additional information concerning factors that could cause results to differ materially from our forward looking statements are described in greater detail in the company's press release issued this morning containing financial results for the year ended December 31, 2020, and the company's filings with the SEC.
And with that I'll turn the call over to Dr. Todd Brady, our president and Chief Executive Officer.
Thank you Joshua and good morning, everyone.
Our year end call is an opportunity to share with you the progress we've made.
At advancing our lead clinical programs and equally important the.
Our strategic vision for Aldara as we move to the next stage in our development.
Over the past several quarters, we have focused on three primary objectives.
First advanced Approx lap into two phase III trials in a clinically relevant sign of dry eye disease ocular redness.
<unk> the statistically significant symptom improvement we achieved in previous phase two and phase III trials.
And positioning our compound as a novel rapidly acting potential first line therapy.
Second complete enrollment in our pivotal phase III invigorate trial in allergic conjunctivitis.
Facilitating the advancement of our proxy lap as the first novel entrant for this disease in decades.
And third.
Began to explore the therapeutic potential of our retinal and systemic disease assets highlighted by <unk> 21, 91, and AVX six to nine.
I am pleased to report that we have succeeded on all fronts.
In February we finalized the design of our phase III tranquility trial of approximately <unk> for the treatment of dry eye disease.
As we have previously announced the trial is expected to enroll approximately 150 patients per arm.
The primary endpoint of tranquility is ocular redness over 90 minutes in a dry eye chamber.
With tier rasp levels, Schirmer test and dry eye symptoms as secondary endpoints.
The protocol will replicate the two day dosing paradigm dry eye challenge design and enrollment criteria of the run in cohort.
Although on a relatively small number of dry eye disease patients in the run in cohort <unk> achieved statistical significance in ocular redness as well as all assessed symptoms in the chamber.
Symptom improvement was observed after a single day of dosing.
And in the dry eye chamber as soon as five minutes after a single dose.
Likewise improvement in redness also occurred within red within minutes following dosing.
<unk> was observed to act prophylactic, Lee, preventing exacerbation of signs and symptoms as well as therapeutically, reducing signs and symptoms following dosing in the middle of the dry eye chamber exposure.
Tranquility and the confirmatory phase III tranquility to trial are on schedule to begin enrollment in the first half of this year with top line results expected in the second half of the year.
Based on demonstrated symptom control in clinical trials and differentiated mechanisms of action <unk> has the potential to provide first line ocular symptom control for dry eye disease patients.
There is no dry eye disease therapy today that acts rapidly.
And health care providers at times must persuade patients to remain on therapy for weeks, even as little or no benefit is experienced.
I'm also pleased to report that enrollment has been completed and the phase III invigorate trial.
A two way randomized crossover trial assessing the safety and efficacy of Approx, he'll app compared to vehicle and subjects with allergic conjunctivitis.
Patients undergo three and a half hours of continuous allergen exposure in an allergen chamber with dosing administered five minutes before and 90 minutes after chamber entry.
The primary endpoint is statistical significance in ocular itching on a nine point scale.
On a majority of 11 time points between 110 and 210 minutes in the Chamber top line results from Invigorate are expected in the first half of this year.
Progress in our lead retinal program also remains on track.
Completion of enrollment of part one of the Phase III Guard trial of AVX 21, 91 for the prevention of Proliferative, Victoria Retinopathy or PBR.
As expected is expected by the end of this year.
<unk> is a serious sight threatening retinal disease with no approved treatment.
Ex 21, 91 has been granted orphan drug status and fast track designation from the FDA for the prevention of PBR.
With regard to our systemic disease programs. We continue to expect top line results from our phase two clinical trials of <unk> six to nine the first orally available rasp inhibitor by the end of the year.
The phase two trials follow a successful phase one clinical trial of <unk> six to nine which demonstrated statistically lower rasp levels in drug treated subjects relative to controls.
And no treatment related adverse events at any dose tested.
As part of our longer term clinical development strategy. We're also readying new compounds for retinal on systemic disease.
The lead molecules of which could be in the clinic as early as next year.
A strong and well capitalized balance sheet is obviously an important asset in our industry.
With the completion in January of our underwritten public offering which raised gross proceeds of nearly $75 million for Aldara. We began 2021 in great shape financially.
We believe our current cash will be sufficient to fund our anticipated operating expenses and execute on our current operating plans through the end of 2023.
We were gratified by the strong support from the existing and new institutional investors.
That participated in the offering.
With that I'll turn the call back over to Joshua to review our financial results for 2020.
Okay.
Thank you Todd.
As Todd noted in January we announced the closing of an underwritten public offering of $7 million 868421 shares of common stock at a price of $9 50 per share.
The offering included $1 26315 shares representing the full exercise of the underwriters option to purchase additional shares and generated gross proceeds of $74 $7 million and net proceeds of approximately $70 million after deducting <unk>.
<unk> discounts commissions and estimated expenses.
Cash and cash equivalents as of December 31, 2020 were $77 $9 million based on our current operating plan and including the net proceeds from the underwritten public offering completed in January 2021, we believe that existing cash and cash equivalents will be sufficient.
To fund currently anticipated operating expenses through the end of 2023, including the completion of the phase III tranquility and tranquility two trials in dry eye disease. The completion of the phase III invigorate trial in allergic conjunctivitis. The phase two clinical trials of <unk> 629 in psoriasis.
Atopic asthma, and COVID-19, and the completion of part one of the adaptive phase III Guard trial.
And PBR.
Turning now to our full year financial results.
Research and development expenses were $24 $7 million for the full year 2020, compared with $44 $4 million for the full year 2019.
The decrease of $19 $7 million in R&D expenses, primarily reflected a reduction in clinical research and development expenditures, partially offset by an increase in non cash compensation costs related to a portion of the contingent acquisition milestone.
Acquired in process research and development expenses were $1 8 million for full year 2020, compared with $6 6 million for full year 2019.
The $4 $8 million decrease is related to lower in process research and development expenses associated with the 2019 acquisition of Helio vision.
General and administrative expenses were $10 million for full year 2020, compared with $12 2 million for the full year 2019.
The decrease of $2 $2 million on G&A expenses, primarily reflected lower personnel costs legal costs public company costs related to continuing compliance with the Sarbanes Oxley Act of 2002 and miscellaneous administrative costs.
The net loss for full year, 2020, with $37 6 million or $1 11 per share compared with a net loss of $60 8 million or.
Or $2 24 per share for full year 2019.
With that I will turn the call back to Todd for closing comments.
Operator, I think we'd like to open the line for questions at this point.
As a reminder to ask a question simply press star one on your telephone keypad.
Question will come from the line of Yigal <unk> with Citigroup. Please go ahead.
Hi, Todd and team thanks for taking my questions.
Could you just expand a little bit on the rationale for choosing ocular redness as the primary endpoint in shrink quilty gives them obviously.
Brian cohort Rasp junior levels was the primary endpoint and then related to that if you could explain the rationale around choosing opt into readiness is a secondary endpoint not a primary invigorate. Thank you.
Hey, Paul Good morning, and thanks for the excellent question.
We have a bit of an embarrassment of riches when it comes to <unk> in terms of objective signs of dry eye disease that we can select.
For approval.
In the running cohort, we had activity in ocular redness and Schirmer test and in Ross as you know all any of those three could be used as a pivotal endpoint.
For the tranquility trial we.
We selected ocular redness for a couple of reasons. One is the data are very strong we achieved statistical significance.
In a relatively small number of patients I think 23 total and are running cohort.
The second reason is that this is the second time, we've demonstrated activity in ocular redness ocular redness was also achieved in the phase two allergen chamber trials and as you know allergy is closely related to that dry eye disease and I think.
Third and most important reason redness was selected is debt there is a considerable commercial advantage to having ocular redness in the label of the drug ocular redness is the only sign that patients care about and therefore, it's probably.
The most important signs to the vast majority of physicians that treat this disease. Many physicians as we've announced previously have complained that patients are concerned about ocular redness and thus a drug that can improve ocular <unk>.
This, especially a drug that can improve ocular redness quickly.
Could be.
A quite advantageous and therefore beneficial.
To patient care.
Your question about the selection of ocular redness as a secondary endpoint in the allergy trial is a really good one.
For approval and allergic conjunctivitis ocular itching is generally the only end point that has used that is the primary symptom.
Allergic conjunctivitis.
Ocular redness is also the primary spine of allergic conjunctivitis, but it's not required for approval and therefore, we've designated ocular redness as a key secondary endpoint for invigorate.
I do think based on my prior comments about ocular redness that there is considerable commercial advantage.
Having ocular redness and the allergy label as well.
All of us are concerned when our eyes appear red.
Amelioration of redness.
It does add to patient care.
Thank you that's Super Super helpful.
One other question could you provide us a little bit more detail with respect to the enrollment criteria for the COVID-19 trial or are these patients hospitalized.
Hospitalized severe moderate mild can you just help us understand the requirements there.
Of course.
Covid enrollment criteria are.
Centered around patients with moderate disease. These days and many of those patients are not hospitalized.
So we anticipate a mix of hospitalized and outpatient.
Populations for <unk>.
The Covid trial on my guess is based on the way things are going and the current status of Covid treatment care most of the patients will be treated as outpatients.
Okay. Thank you very much Todd.
Thanks Nicole.
Your next question comes from the line of Louise Chen with Cantor Fitzgerald. Please go ahead.
Hi, congratulations on all the progress this quarter and thanks for taking my questions. So first question I had was back on the tranquility trial, just curious if you've had a chance to speak to the FDA about your primary endpoint and what they might think of that and then secondly, the dry disease market is getting crowded with many different companies developing different Matt.
<unk> for dry eye disease, and just curious if your product is approved where do you expect it to fit into the treatment paradigm and then last question I have for you is just how should we think about operating expenses for 2021. Thank you.
Yes.
Louise Good morning, and thank you for the question I'll address the first two questions and turn on a third over to Joshua to address the financials.
Yes.
The type C meeting, we held with the FDA in the middle of last year was designed specifically to clarify the agency's position on our potential primary endpoints for tranquility.
You can rest assure that we clarified with the agency that readiness can be used as a primary endpoint. Other companies have used redness as a primary endpoint at least as redness relief to.
Two on objective sign of dry eye disease. So we're quite comfortable debt our readiness will be acceptable in our case as you know the agency also clarified that RAF.
The target of approximately <unk>, an AVX 69 can be used as an objective sign on dry disease and as you also know Schirmer test is also a possible.
On all three of those will be assessed in the tranquility trial with redness.
The primary endpoint.
One of my favorite topics is where does where approx elapsed fit.
In the treatment paradigm.
For dry eye disease as I mentioned in my prepared remarks, one of the major issues if not the major issue in dry eye treatment today is that the available therapies do not work quickly.
<unk> and Restasis, often take weeks to months.
For patients to feel better.
In 2019, and paper was published indicating that the median discontinuation times four is I had written restasis are between one and three months.
There is nothing more challenging for a health care provider than having to convince patients to stay on drug when there is no perceived benefit to the patient.
And that is precisely what is happening in the dry eye therapeutic landscape today.
<unk>, therefore is a true paradigm shift and solves many of the problems that I've just described because the drug acts rapidly that is within minutes as was demonstrated not only in the run in cohort of tranquility, but also.
<unk> and the phase two allergen chamber trial.
<unk> offers.
A manner of treating the disease rapidly in theory patients could present to a health care provider.
A dose of Approx that could be administered in the office of the health care provider and assuming the patient has a red eye and is currently experiencing dry eye symptoms, which is often the case for patients that present to health care providers.
Patient could in theory feel and look better before leaving the.
The healthcare Provider's office.
For all of these reasons, we believe that <unk> represents a first line therapy in summary.
The key advantage is rapid onset and we believe rapid onset fall the primary problem with dry disease therapy today.
Josh do you want to talk about the financials.
Of course.
Thanks for the question Louise.
With our planned activity in 2021, including tranquility tranquility to invigorate advancing our systemic program <unk> six to nine and development in <unk> 'twenty 191.
You should expect our spend particularly in R&D to increase versus 2021.
As far as timing goes as you know that can be a bit variable, but I would anticipate that our spend would increase quarter over quarter as the year progresses.
Okay. Thank you very much.
Thanks Louise.
Your next question comes from the line of Kelly <unk> with Jefferies. Please go ahead.
Thank you for taking my question and congrats on the great progress.
Question, two BLA filing is expected by this year and called on.
On slide on net conjunctivitis beyond top line data on what other things.
And they're willing to work on getting the package ready. That's my first question and the second question is how.
How should we think about our marketplace on day two alcohol indication.
Do you see from IV area, where you can actually do promotion ASO approach on that given that a day.
Sure I, just im working on that.
And that means I want the option and also now also Shannon I called one primary endpoint. Thank you.
Kelly and good morning, good to hear your voice and thank you for the questions.
So there are many aspects of a successful the new drug application submission.
Which you allude to.
Only one of them or is your efficacy trials.
Obviously, we're very optimistic about invigorate.
And we're very optimistic.
About a tranquility based on the phase III trials in allergy and the running cohort of tranquility not to mention the prior trials in dry eye disease that have demonstrated.
Activity of approximately <unk> incentives inside the other components of NDA submission concern.
<unk> study safety studies are a requirement for NDA submissions.
In addition to safety studies is the magnitude of the safety database, which is really a summation of all the patients that have been exposed to drug throughout the clinical program from the beginning starting in phase one.
We have now over 1100 patients that have been exposed to a approx a lap at concentrations higher than two 5%, which is our concentration we intend to take forward or are taking forward.
And at dosing frequencies that exceed the dosing frequencies that we are currently using we have experienced or observed no.
Safety events, which typically concern the visual acuity.
<unk>.
Slit lamp exam of the front of the eye.
Intra ocular pressure and adverse events.
It's remarkable that so many subjects in clinical trials.
Have been exposed to drug and we have no reports of clinically relevant safety issues. The third aspect of NDA submission concerns chemists.
Chemistry manufacturing and controls and there the FDA is primarily concerned with the cash.
With the.
Manufacturing process the commercial process.
On the stability of the commercial batch and Im happy to say that we believe we're in very good shape with regard to all those <unk>.
Standards as they relate to CMC. The only thing I'll add is that the safety trial for dry eye disease is ongoing.
The FDA requires debt for NDA submission, we have a certain number of patients with six months of exposure to drug and we believe that we're on track to reach that milestone.
By the end of this year.
Kelly.
Regarding your second question in terms of other opportunities for approximate App I think one of the benefits of being in immunology company is debt.
It products in the immune mediating space have broad applicability. Many if not most diseases have some inflammatory component to them and therefore, the potential applications for drugs that are active immunologically.
Our broad.
Allergic conjunctivitis and dry disease as you know Kelly are probably.
If not certainly the two largest anterior segment and inflammatory diseases.
But there are other diseases, we've announced trials previously in anterior uveitis.
<unk> there are scleritis there are many other diseases.
It involves inflammation of the anterior segment and I think like the use of corticosteroids.
The potential for broadly acting drugs like for approximate app.
Is is considerable our plan currently however is to focus on dry eye disease.
And allergic conjunctivitis, but as you alluded to.
The potential application of approximately <unk> down the road is significant.
Thank you very much for the color congrats again.
Thanks Kelly.
Your next question comes from the line of Justin Kim with Oppenheimer. Please go ahead.
Hi, good morning, Thanks for taking the question.
Maybe just one on quality.
Quality when you think about the size and scope of the studies could you share any thoughts on how you think about the powering for the primary on the key secondary endpoint.
Yes happy to Justin.
We take statistical powering very seriously.
Our company policy is to power at 90%.
Which is generally the most conservative threshold debt to biotech companies use.
We're enrolling clinical trials.
There are several different ways to power as you know we pick the most conservative.
Threshold for powering to get to 90% and the powering is all based on ocular redness.
And the tranquility run in cohort.
On the differences between groups were approximately <unk> two units, we used slightly less than that difference to power. The main cohort of tranquility I'll also comment briefly on powering for RASK I believe or we believe at this point that.
The powering for redness includes powering for wrap that is we should be at 90% power to detect differences in RASK based on the data from the run in cohort. So those two endpoints I believe are well covered in terms of powering.
Got it thanks.
Maybe then just as we think about the patient population in dry eye disease.
Yes.
Which endpoints may have more or less variability sort of inter patient I mean is it.
There's some color you could offer us there based on sales.
The study that you did in the measurements that you were taken in the unearned portion.
So really interesting question, Justin because variability in dry eye disease as everyone knows is considerable.
And the variability among the endpoints.
Specifically is considerable.
We are hoping that RASK.
Provide a very objective measure.
Disease severity, although the assay for Ross is somewhat complex tiers must be extracted.
Frozen shift to a central lab and on.
Analysis must be performed and so forth.
Requiring much more time than the standard that dry disease assessments.
Readiness, we believe we have controlled for by including a central reader.
For the Tranquility studies.
<unk> is assessed with digital photography.
Such that light levels, Hugh color intensity saturation contrast et cetera.
Our all rigorously controlled.
And then as I mentioned those digital photographs are read by a central reader. So we're hoping that the variability that we see with some dry eye endpoints will be limited.
By the controls that we've outlined for for ocular redness.
Got it got it.
Our final question.
Could you just expand for us a little bit on the phase III Invigorate study endpoint and how we should think about sort of the hurdle rate with respect to maybe the regulatory hurdle as well as maybe the commercial hurdle there.
The FDA stance on allergic conjunctivitis is interesting in debt, they're particularly interested in assessing the onset and duration.
On a therapy.
An allergic conjunctivitis, the allergen chamber is particularly well suited to assess onset and duration because patients are continuously exposed to allergan over three five hours a.
On the particular primary endpoint as I mentioned in my prepared remarks.
Is the achievement of statistical significance between drug and vehicle over a majority or I should say at a majority of time points in a pre specified range.
As you can see on our corporate deck, we specified a range that in phase two with.
With highly statistically significant between drug and vehicle.
Within that range, the FDA will be looking not only for the achievement of a majority of endpoints are time points, but also.
The onset of the drug and how long the drug acts within that range based on the phase II data, we would expect the onset to be the first time point and the duration to be the last time point.
But that is sort of the rubric that the FDA is using to assess the drug.
Got it thanks, so much.
Thanks, Kevin.
Your next question comes from the line of Matthew Cross with Alliance Global Partners. Please go ahead.
Hey, guys good morning, and congrats on another quarter of progress.
A couple of housekeeping questions from me today.
So first off can you remind us how much lead time, you would expect between the initiation and completion of tranquility bought one versus two I guess given the overlap in design would you anticipate the vs will start and more or less in lockstep for the first and second half of this year or is there any kind of intermediary step between these two studies, we should be considering as we're thinking about timeline.
For the year.
And then the second one I had was kind of similarly for pretty ex six to nine in these three different indications being studied in phase twos is there anything you can say about the pacing of enrollment between these three are any of them kind of clearly advancing more quickly more slowly.
Or may readout more quickly this year.
By virtue of the endpoints that you're examining just trying to get a better sense of how these may complete throughout the remainder of the year and distinguish themselves from one another.
Yes.
Thanks, Matt good morning.
The difference between tranquility, one and tranquility to in terms of protocol is zero.
The intent is to replicate tranquility, one with trade quality too.
There is an intentional stagger in timing between tranquility, one and tranquility to the reason for the stagger is that we want to have some time to analyze the results.
Tranquility, one prior to database lock of tranquility too.
This allows us if need be to adjust the statistical analysis plan. Accordingly, I do not expect any significant changes in analysis between train quality, one and tranquility too, but the stagger is there as a conservative measure just to make sure.
<unk> debt no changes are are needed.
Regarding the phase III trials for six to nine too early to say in terms of timing I would say the trials for psoriasis and asthma and COVID-19 are more or less in locked step at this point, but the exact timing of the rig.
<unk> for all three of those phase II trials will depend on enrollment and how that enrollment is affected.
By Covid and other factors over the summer.
Got it I appreciate the insight on both of those Tom.
Thanks, again, our pleasure Matt.
Your next question comes from the line of Julian Harrison with BTG. Please go ahead.
Hi, good morning, Congrats on all the recent progress and thank you for taking my questions first I'm wondering how we should be thinking about the read through from your upcoming allergic conjunctivitis data to the tranquility trials keeping in mind, both her and chamber settings beyond.
Involving different conditions I'll deal with significant overlap are there any other nuances or differences worth highlighting here between trials, especially pertaining to the redness data you're collecting a niche.
Per usual Julien an excellent point about the read through between the allergen Chamber trial, and the dry eye Chamber trial.
I do think there is read through and in our tranquility run in data released slide deck, we had a slide that <unk>.
Included all four symptom ensign readouts across the allergen chamber on the dry eye chamber.
A trial.
Point of that slide is that whether its a dry eye chamber or an allergen chamber and whether its symptoms or redness for approx of lab seems to behave the same way that is activity within minutes.
So I do think that there is read through between invigorate and that tranquility, both our challenge studies.
Both are using a chamber and both are enrolling a population of patients that do have some pathophysiological overlap as I mentioned in my answer to <unk> question. There is about a 50% overlap between dry eye patients.
Allergic conjunctivitis patients specifically about half the patients that complaint of itching, which is the symptom of allergy also complain of dryness and about half the patients that complaint of dryness also complaint of itching and there are many other overlaps between these two patient populations, including pollen pollen.
<unk>, obviously exacerbates allergy, but it's also probably the key exacerbate or on.
Of dry eye disease and to make matters worse as you know Julien the therapies for allergy, including anti Histamines nature, I dryer and at least one of the therapies for dry eye disease seems to induce ocular itching.
The key symptom of allergy, so I would say not only do the trials themselves invigorating tranquility have overlap in terms of protocol and methods, but also the patient population.
Is is overlapping in terms of of anterior segment inflammatory the pathophysiology and to boot approx lap seems to behave the same way in terms of improving symptoms and signs are rapidly in these chambers.
Got it okay. Thanks, Todd that's helpful. And then sorry, if I missed it on the Vitreoretinal lymphoma program I'm wondering when we should expect an update on the path forward are you still anticipating the possibility to file an NDA without the need for any clinical trials.
The answer is potentially I think you will hear more from out there on our planned path forward with lymphoma and other retinal diseases that can be treated with AVX 21 91.
Shortly.
Okay, great. Thanks very much.
Your next question comes from the line of Esther Hong with Baron Berg. Please go ahead.
Hi, good morning.
As the program former proxy that moves forward.
Can you speak about the commercial strategy.
For Apache lab that will potentially be approved for both dry eye disease and.
On AC thanks.
Good morning.
The commercial strategy is something that we've.
Historically thought a lot about as you pointed out.
As her proxy lap nears NDA submission and he commercial and go to market strategy is particularly important.
As I mentioned previous answers, we believe that for practical App is well positioned.
In the market today, given that as I mentioned, the current therapies take a long time to work and reprocess a lab seems to work.
Quickly on.
A question, we often get is is <unk> going to be marketed or launched by Aldara.
Thank the good news is debt we have considerable optionality around a go it alone launch versus a partnered launch on.
On one hand, many of the health care providers that prescribed dry disease therapies are spread across the continuum of patient care from optometrist and nurse practitioners to general ophthalmologists to general practitioners to anterior segment ophthalmologist. So there is a.
The wide prescriber base that probably is best served by a large company with a significant commercial footprint on the other hand.
Small ophthalmology companies have and are launching.
Anterior segment drugs on their own so it's certainly feasible debt aldara could do so.
As well I believe that based on what other companies are currently executing on the standard sales force for a front of the eye launch is in the range of 1% to 300 sales Representatives, which again is feasible for small companies in summer.
I think debt, we have many options as it relates to to launching reprocess a lab regarding retina I do think that retina is something a small company not only can do but maybe even should too because the prescribing base for rare retinal diseases.
<unk> is very limited.
In not only our <unk> case that probably other companies cases that are working on rare retinal diseases that physicians that prescribe. These drugs are the ones running the clinical trials and so that prescriber base is very familiar to the company.
Okay.
That's very helpful. Thanks.
Thanks Esther.
Your next question comes from the line of Edwin Zhang with H C. Wainwright. Please go ahead.
Okay.
Thanks for taking my question congrats on the.
Recent progress.
So quick one on pdx six to nine.
Primary compound for your systemic strategy.
Can you briefly talk about the trial design of the Phase two study in Florida assets. For example, the primary endpoints on the size of the study. Thank you.
But thanks for the question Edwin and I, particularly thrilled to talk about <unk> six to nine because I think.
It represents a transformative event for our company as we have previously been focused primarily on anterior segment ocular disease any ex six to nine represents a transition.
From ocular disease to systemic disease as you know.
The number of systemic diseases that relate to immunology is considerably larger.
The number of diseases in the eye debt.
Our immunologically based.
And thus we are particularly thrilled.
With the launch of the Phase III trials for <unk> 69, there is a systematic.
Well thought out approach to testing <unk> hundred nine as you know there are different kinds of inflammation.
In particular, they sit on a continuum between allergy and autoimmune disease.
Different kinds of cytokines different cytokine profile.
And other pro.
Pro inflammatory mediators exist along the continuum and our idea is to assess the activity of <unk> 69 in both camps.
And thus we are able to guide the future development of 609 in phase two b clinical testing next year.
I'm happy to comment on all of the trials generally in terms of protocol.
For asthma and psoriasis and Covid. These are all phase Iia proof of concept trials.
In the case of the asthma and Covid. These would be controlled trials in the case of psoriasis.
Single arm trial, the numbers of patients in each trial is between 10 and.
30 patients the idea is that by the time the results are available for each of the trials, we're able to assess the biomarker response.
AVX six to nine there are no primary endpoints because these are proof of concept studies, obviously safety and adverse events will be a key metric, but really our focus as I mentioned is on the biomarker activity.
Effected by <unk> 629 in particular, we're looking specifically at cytokine profiles and rasp levels. We have other biomarker assessments specific to certain of those trials, but in general I think.
The Street will have a very good understanding of the kind of cytokine profiles effected by AVX 600 on bi.
By the time, the three phase III readout at some point this year.
Very helpful. Thank you.
Our pleasure Edwin.
Your next question comes from the line of <unk> <unk> with Jones trading. Please go ahead.
Hi, good morning on thanks for taking my question I think you mentioned that some new molecules into the clinic next year could you give more color on the mechanism of these compounds will also be based on the rash.
And for these molecules what indications might be of interest. Thank you.
Thanks per car and if this is an excellent.
Transition to the future of Alterra.
One of our core strategies is to continue to develop new molecules.
As part of pipeline progression I see many biotech companies and the focus is on.
A single asset or a series of assets with very little behind the initial pipeline, we do not intend strategically.
Strategically to focus on a certain number of assets and those assets only instead, we intend to develop.
Almost evergreen source of new compounds.
The answer to your question about Ross is yes.
These compounds are rasp inhibitors, there is a large chemical composition space.
Available to us regarding rasp inhibition as you know we seem to be the only company focused on Ross.
And we have developed what we believe to be truly foundational compositional structures.
Around the rasp inhibition and thus have what we believe is a considerable the freedom to operate I am particularly excited about these new compounds. Many of them are from a RAF inhibition standpoint, more potent than were proxy lap and <unk>.
Two nine others have specific advantages as they relate to PK.
Blood brain barrier penetration.
Metabolism.
Dosing formulation solubility et cetera. So we've had we've undergone specific efforts to not only discover new rasp inhibitors.
But.
Prioritize new molecules for advancement as I mentioned, we anticipate being in the clinic with <unk>.
A compound one compounded leased.
Next year and those compounds will be targeted to.
Retina and or systemic diseases.
Our final question will come from the line of Yale Jen with Laidlaw <unk> Company. Please go ahead.
Good morning, Todd and add my congrats on the progress.
Uh huh.
First question is.
Regarding the invigorate.
Trial, just talk from our investors.
It is a nice point scale each for the current study.
Remember correctly the prior study was full points.
Skill.
Could you provide some color for the differences.
Yes, good morning Yale.
And thanks for the question, it's just a matter of semantics.
It's the same scale.
The reason, it's a nine point scale is because it's a zero to a core scale with half unit and permits.
So if you add up zero to four and you include <unk>, five and $1 five et cetera.
Youll get nine points. It's the same scale, it's sometimes called a four point scale on sometimes called the nine point scale, but in the end, but we're talking about precisely the same thing.
Okay, Great. That's very helpful and maybe one more question here, which is for 'twenty one.
91.
Could you reiterate what is the study design at this moment and what's the endpoint you anticipate.
For the first part of the study.
Okay.
Right Youre speaking Gayle of PBR.
Yes, yes.
Yes.
Yes, yes. The guard trial is designed to assess retinal detachment rates over six months of therapy and compare retinal detachment rates.
Of standard of care, which is essentially <unk>.
Monitoring.
Those of AVX 21, 91 <unk> injections.
The problem with <unk> is retinal detachment.
Retinal detachment occurred.
Urgent surgeons can replace the retina.
But then there is scoring behind the retina that's P VR.
And that scarring.
Leads to two issues one is loss of sight and two is.
Further retinal detachments scar growth the retina is pushed back off.
The.
Hi.
And that's why the FDA has agreed that retinal detachment.
Rates are the.
The proportion of patients with retinal detachment can be used as a primary endpoint to compare standard of care and <unk> The guard trial.
We expect to be enrolled this year because its a six months follow up.
Results from that trial would be expected next year and of course once those results come in we'll visit with the FDA again talk about next steps.
Maybe one more question one more question here, which is the is the study a placebo controlled or are you all look.
Paired with historical.
Natus.
The control is standard of care.
Patients are randomized one to one to either receive this series of AVX 21, 91 injections or standard of care and as I mentioned standard of care means monitoring.
The standard of care today is to repair the retina and not to treat PV or there is no treatment other than.
AVX 21, 91, that's used today for.
For PBR. So thus standard of care is essentially repair of the retinal detachment and monitoring.
Okay, great. Thanks, a lot I appreciate it and congrats thank you Yale.
At this time I will turn the call back over to Dr. Todd Brady for any closing remarks.
Well, thank you operator.
A number of virtual events coming up.
Including a presentation this afternoon.
The OIS dry eye innovation showcase and next Tuesday at the Oppenheimer annual Healthcare conference.
As always we look forward to connecting with you.
And keeping you updated on our progress.
Ladies and gentlemen that will conclude today's call. Thank you all for joining and you may now disconnect.
Yes.
[music].
Okay.
Okay.
[music].
Okay.