Q4 2020 Cara Therapeutics Inc Earnings Call

[music].

All participants are now in listen only mode. There will be a question and answer session of the N. Please be advised that this call is being recorded at the terrorists request I would now like the turn the call over to Cara team. Please proceed.

Good afternoon. This is Jack Hill, the <unk> Smith with Stern Investor Relations and welcome to Cara Therapeutics fourth quarter and full year 2020 financial results and update conference call. The news release became available just after four P. M. Today and can be found on our website at www Dot Cara.

The www Dot Cara Therapeutics dotcom.

Also listen to a live webcast and replay of today's call on the investors section of the website the.

Before we begin let me remind you that statements made on today's call regarding matters that are not historical facts are forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995. Examples of these forward looking statements include statements concerning the expected timing of the data readouts from the.

The company's ongoing clinical trials the potential of results of ongoing clinical trials timing of future regulatory and development milestones for the company's product candidates, including the company's projected timeline for FDA review and potential approval and commercial launch of course to the IV, but that's.

For the company's product candidate to the alternatives in the therapeutic areas of investigated and the company's expected cash reach because such statements are subject to risks and uncertainties actual results may differ materially from those expressed or implied by such forward looking statements right.

The risks are described more fully in carry therapeutics filings with the Securities and Exchange Commission, including the risk factors section of the company's most recently filed quarterly report on form 10-Q, and its other documents subsequently filed with or furnished to the securities and Exchange Commission all forward looking statements made.

In today's call speak only as of the day on which they were made Cara therapeutics undertakes no obligation to update such statements to reflect the events that occur or circumstances that exist. After the day on which they were made.

Participating on today's call are Dr. Derek Chalmers, Cara, President and CEO and care of Chief Financial Officer, Thomas Reilly I'll now turn the call over to Dr. Chalmers.

Thank you John and good afternoon, everybody and thanks for joining us on the call. This afternoon.

So despite the circumstances that we're all painfully aware of all of 'twenty 'twenty was certainly a significant and very productive year for cash.

Uh huh.

As we advance the late stage clinical development of our lead product candidate for silver for the treatment of providers across the range of patient populations all of them.

<unk> as we announced today and the recent acceptance and filing of our NDA brokers to the injection for the treatment of pruritus in hemodialysis patients.

That's N D E filing marks the truly significant milestone for our company and.

And most importantly for the large proportion of hemodialysis patients who suffer from this and tractable untreatable pruritus.

So detrimental to the quality of life.

And I'd like to thank the entire car T true.

Tirelessly to bring the first in class therapeutics from.

And has discovery through development to the completion of S. T E filing.

And we look forward to working with the F D. A.

Of the across the desk.

If granted priority review of the potential approval and commercial launch in the second half of this year.

Now with respect to pursue the injection commercial launch we were also very pleased to execute our strategic license agreement with the D. For Pharma, Inc. Q4 of last year for the commercialization of our pursuit of injection and U S dialysis clinics we.

Belief that the force established U S neurology sales force and productive relationships with U S. Dialysis organizations will provide the basis for increased launch momentum and the adoption after Susan injection in the U S market and I'll cover the details for that arrangement.

And a little debt.

Lastly, we also expanded our oral pursuit of the clinical development program with the initiation of the for phase III trial in patients suffering from neuropathic related pruritus.

Specifically in the town Heresthetic of patients.

Evaluating the ability to treat pruritus of of Neuropathic origin. In addition to our ongoing clinical development programs and systemic and dermatological chronic pruritus.

Further support the use of oral crusade of as a future of broad Antipruritic agent.

Building on this momentum on from 2020. In addition to protect you the approval on launch of pursuit of injection in the second half of 'twenty. One we expect major clinical data readouts on advancements throughout the upcoming year and on the call today I'll provide a brief update on each of our programs and what to the.

Expect throughout 2021.

Before I get to that let me remind you that good of the ongoing COVID-19 pandemic and in accordance with the Fda's updated guidance for conducting clinical trials.

We have implemented numerous clinical and operational measures to prioritize the health and safety of patients our employees and study investigators and to minimize potential disruptions to the ongoing clinical studies.

And I'm pleased to say that due to the entire cara team's continuous dedication and hard work.

We remain on track to day to meet our main clinical and regulatory goals for the year and continue to enroll patients across ongoing oral chris's of trials.

So getting to the programs starting with our lead program for pursuit of the injection.

And hemodialysis patients with the <unk> associated pruritus as a reminder, this is the patient population, where there is significant unmet need.

With approximately 40 to 50 per cent per cent of patients.

The moderate to severe pruritus with no therapies currently approved in the U S or in Europe.

We believe pursuit of of injection has the potential to fundamentally change the treatment paradigm for these patients.

With the NDA for Christy is on injection that is filed we remain focused along with our U S licensing part of the for pharma on preparation for an anticipated U S. Commercial launch as early as the second half of this year.

As a reminder, under the terms of the feed for license agreement.

<unk> received an upfront payment of $150 million composed of $100 million in cash and $50 million in equity purchase upon U S approval arrows eligible to receive a further $50 million of equity purchase and there is potential U S commercial sales milestones of up.

The $240 million.

By far we will have the exclusive rights to commercialize the pursuit of injection and non Fresenius medical care.

North America dialysis clinics in the U S.

Under our current 60% V for 40% profit sharing arrangement.

And that's based on profit from net non Fresenius medical care clinic sales.

Recall from our original Cara.

Beat for Fresenius license agreement that we executed in 2018, we Havent established 50, 50 profit split arrangement and Fresenius clinics already in place for the U S.

Overall, we see this as an ideal agreement, which allows us the both leverage the force established commercial infrastructure and capabilities on.

<unk> retained commercial upside from a profit sharing arrangement.

Transition of both medical affairs, and commercial launch activities to the the Fourteens have progressed well since we executed that agreement over the last two quarters and we're well prepared for a potential for silver injection U S launch as the.

As of the second half of this year.

Moving on to our pipeline programs focused on oral pursue the.

Let's start with our program in pre dialysis decay of D patients with moderate to severe pruritus. We have previously reported positive top line results from our 12 week phase two trial evaluating the safety and efficacy of three tablet strengths of oral pursuit of a two 5.5 in one.

Milligram once daily.

Based on that data, we identified the one milligram one milligram tablet strength of oral pursue the as the dose level to take forward into phase III.

To that end, we will be conducting on entities two meeting with the FDA in Q2 of this year, which will enable our projected pivotal phase III trial initiation in the second half of 2021.

Moving on to atopic dermatitis, and our ongoing care phase two dose ranging trial in Q2 of 2020, we completed the planned interim unblinded conditional power of assessment.

After approximately 50% of the originally targeted.

The number of completed the designated 12 week treatment period.

Based on the independent data monitoring committee's recommendation and to maintain a conservative statistical power on it. The main end points, we increased the target trial size by approximately 28%.

In Q4 of last year, we announced the trial was fully enrolled on approximately 400 patients and we currently expect to read out top line data in the first half of this year.

Finally, with the goal of further establishing the broad antipruritic applicability of pursuit of that across patient populations. We recently announced the initiation of the phase II proof of concept trial for.

For the treatment of moderate to severe pruritus in patients suffering from Natasha kind of static or N P.

The nerve disorder characterized by chronic pruritus of the upper to the Meadowbank.

It's estimated the chronic pruritus of up to 30% of the United States population and about 8% of these patients suffers suffer from some form of neuropathic edge, including N P.

There is currently no well defined treatment for N P and conventional treatments such as anti Histamines and topical steroids are largely unaffected. So the remains of significant opportunity for oral pursue the as a novel therapeutic approach for these patients.

So overall our progress in 2020 has laid the foundation for a transformative year ahead at Cara, we very much look forward to the projected approval on commercial launch of pursuit of the injection on the second half of 2021.

Topline data readout from our care phase two trial of oral pursue the in atopic dermatitis in the first half of 'twenty, one initiation of our phase III registration trials for oral <unk> in stage three to five pre dialysis <unk> patients in the second half of this year as well as continued program.

On ongoing phase II trials, and liver disease patients and N P patients and we will be bringing updates on the progress across all of these programs in the coming quarters.

So with that I'll now turn over to Tom the detailed the financial results for the quarter and for the full year of Tom.

Thank you Derek.

As a reminder of the full financial results for the fourth quarter and full year 2020 can be found in our press release issued today after the market closed.

For the fourth quarter of 2020, we reported net income of $78 9 million for $1 60 per basic share.

And $1 59 per diluted share.

Compared to a net loss of $28 6 million for 61 cents per basic and diluted share for the same quarter of 2019.

In the fourth quarter of 2020, we recognized revenue of $112 1 million.

Of which $111 6 million.

Related to the 'twenty 'twenty license agreement with fee for.

0.5 million related to the license agreement with the for Fresenius.

This compares to $4 5 million of license and milestone revenue during the fourth quarter of 2019.

Which related to the license agreement with these free for Fresenius.

Research and development expenses were $27 1 million in the fourth quarter of 2020.

Compared to $29 9 million in the same period of 2019.

The lower R&D expenses in 2020 were principally due to a net decrease in costs associated with clinical trials and travel costs.

Firstly offset by a $2 5 million milestone payment made in connection with the license agreement with interest.

Increase in payroll and related costs and increases in stock compensation expense.

General and administrative expenses were $6 seven in the fourth quarter of 2020.

Compared to $4 6 million in the same period of 2019.

The higher G&A expenses in 2020 were principally due to increases in payroll and related costs.

Commercial costs and insurance costs.

Other income was zero point for millions in the fourth quarter of 'twenty 'twenty compared to $1 2 million in the same period of 2019.

The decrease in other income was primarily due to a decrease in interest income, resulting from a lower yield on our portfolio of investments in the 2020 period.

Now turning to the full year 2020 of financial results.

For the full year ended December 31, 2020, we.

We reported a net income of $8 4 million or <unk> 18 per basic and diluted share.

Compared to a net loss of $106 4 million.

Our $2 from 49 per basic and diluted share for 2019.

Revenues for the year ended December 31.

2020, $135 1 million as compared to $19 9 million in 2019.

We recognized $134 4 million of license and milestone revenue for the year ended December 31 2020.

Of which of $111 6 million related to the 2020 license agreement with V for.

$22 3 million related to the license agreement with the for Fresenius.

And the <unk> 6 million related to achievement of milestone related to our license agreement with CK D pharmaceutical.

We recognized $19 7 million of license and milestone revenue for the year ended December 31 2019.

Which related to the license agreement with fee for Fresenius.

Research and development expenses were $107 9 million for the full year ended 2020.

Compared to a $113 8 million for the full year ended in 2019 for.

The lower R&D expenses in 2020 were principally due to a net decrease in clinical trial costs.

Lower payments made to in tariffs.

The decrease in travel costs.

The offset by increases in stock compensation expense.

Payroll and related costs and cost of kind of clinical compounds sales.

General and administrative expenses were $21 8 million for the full year ended December 31, 2020, compared to $17 7 million for the full year ended December 31 2019 the.

The increase in 2020 was primarily due to increase in commercial costs insurance costs per.

The rolling related costs, and partially offset by a decrease in consulting costs.

Other income was $2 3 million for the full year ended 2020.

Compared to $4 5 million for the full year ended 2019.

The decrease in 2020 was primarily due to a decrease in interest income, resulting from a lower yield on our lower average balance of our portfolio of investments in 2020.

As of December 31st 2020, our cash cash.

Cash equivalents and marketable securities totaled $251 5 million.

Compared to $218 2 million at the end of 2019.

The increase in the balance resulted primarily from of $38 4 million from the sale of common stock on the license agreement with the for.

Partially offset by $5 5 million of cash used in operating activities, which includes the $111 6 million of cash received under the VI V for agreement, which was recorded as license and milestone revenue.

Turning to our financial guidance.

Just on the projected costs for our clinical development plans and timing expectations.

We expect that our current cash cash equivalents and marketable securities as of December 31, 2020 will be sufficient to fund our operations into 2023, 19, net accounting for any potential milestones or potential product revenue under existing collaborations.

I will now turn the call back over to the operator for Q&A.

At this time I would like to remind everyone in order to ask your question you May Press Star then the number one on your telephone keypad.

Again, Thats star one on your telephone keypad, we'll pause for just a moment to compile the Q&A roster.

Your first question comes from the line of David and Selim from Piper Sandler Your line is open.

Okay.

Mr. David and Selim Youre line is open.

Yeah.

We can we can move on it's all of US David has the problem there maybe solves that we go back for them.

Your next question comes from the lineup Annabel Sammy from Stifel.

Your line is open.

Hey, everyone. This is abbott's on on for Ann go today, a couple of questions from us.

Firstly with the NDA for NDA filing for <unk> two the accepted in February when do you expect to know whether the drug is granted priority review.

And secondly are you able to provide an update on progress made by the for on site. The Apple reimbursement discussions and does the fact that there are numerous renal drug seeking to that conclusion make these discussions any more difficult.

Okay High average thanks for that yes. So.

On.

On the first question on the NDA. So so we had confirmation from the FDA last week electronically that the NDA was accepted and filed but within that confirmation for filing.

On the FDA also indicated that the official filing later.

We're still in process. So so that was in process, we have not yet received that letter.

And therefore, we don't yet have the information on priority review R&D day so.

We expect that letter to arrive soon.

But the FDA and the FDA, there's no there's no prediction on timing yet.

Unfortunately.

On the reimbursement.

Question of course, you're aware of the two.

The doctor of reimbursement is not discretionary.

Qualifies for to adapt for reimbursement by meeting the criteria that are legislatively defined.

And the ESR the legislation, so where the class one.

N D a.

After.

January 2020, and we're going to be used in the dialysis setting. So so that we're very confident upon and we are of good team at Cara, who continues to lead our interactions with CMS and discussions not only related to the dapper.

Reimbursement beyond the Doc on now we started to include our partner there and those discussions on there.

It will help us to one and two as we progress.

The discussions but to DARPA is.

It's something we qualify for and we will be applying for that.

After we get approval of course of injection.

And does the sort of desire for many companies to be included into that sort of.

Complicate those discussions of our timelines.

Well I don't think so that's the way the legislation was defined was the encourage innovation for hemodialysis patients and of those companies compounds meet those criteria for an innovative.

The compound for the treatment of hemodialysis patients than the wood Dale we.

Qualifies which of that.

Got it.

Okay Avatar.

Thank you Derek.

Thanks for your call.

Your next question comes from the line of Christopher Howerton from Jefferies. Your line is open.

Hi, everyone. This is Brian <unk> on for Chris Your sort of to your question. The first one is if you could speak a little bit about the dosing decisions and the CK the.

And neuropathic pain studies and whether this corresponds set of differences of disease severity.

Specifically.

We're interested in what led to your decision to choose two milligrams versus one milligrams twice daily on the neuropathic pain study the <unk>.

Second question would be around if there is any relevant differences on the characteristics of underlying biology results for <unk>.

The the DNA of the population.

What the key supportive evidence of gives you confidence for success.

Thanks, so much.

Yes, Thanks, Brian.

The dosing question is actually really related to PK.

Availability of the drug.

So for the CCAR the study's oral studies as you know Chris of as eliminated almost entirely.

Via the kidney and so we looked at the PK.

Exposures and specifically stage three to five TKD patients to define what tablet strength and.

On frequency of dosing would match the Auc's, we know we're highly efficacious from our IV studies.

And that's why we come up with the dose of one mill of <unk>.

<unk> D for the CK D patients when we missed the atopic derm there.

Those patients of course of normal kidney function and so.

And again, we looked at the PK in normal individuals on to match that.

Desired AUC.

There.

We needed to get the twice a day dosing at the one milligram level so that the that.

That was the rationale really on those two studies on the Natalya Parenthetically, we really view of the essence of proof of concept trial.

And we know, particularly in preclinical models looking at neuropathy pain.

On different modality, but actually same.

In terms of <unk>.

Peripheral nerve transmission via the DRG that we require slightly higher drug dosage, Inc. And those neuropathic type models and so that was that was partially the rationale behind cushion up the does that when we look at neuropathic related pruritus and also.

The proof of concept trial.

We'd rather use the higher dose and see what level of efficacy we can achieve their single dose.

And as you know we've dosed the drove up to 10 milligrams a day orally with no safety concerns so it's well within the range we've used.

We've used before and then you're kind of you're.

Second kind of 30000 per question on mechanism.

We've indicated a few times I think.

When we look at the mechanism for cursive are actually related to activation of Kappa receptors directly on the C fibers and the in the.

Epidermis.

And during most of the relay the pruritus.

That mechanism is really agnostic to the initiating pathology, so whether that of CK D end organ disease, and we know the cytokine profile there and it certainly different in the dermatological inflammatory state that really shouldn't make a difference based on our mechanism of action to efficacy and that.

It's certainly something we've seen in preclinical models of various you know that the.

Allergies.

These two debt drove all of the with the.

The transgenic.

Models associated with for example, atopic dermatitis and showing good efficacy and those.

Validated predictive models. So so we have high confidence in the mechanism there.

Should really be agnostic to the initiating the initiating pathophysiology, but we don't the good news Brian is we don't have too long to wait to actually get the answer on that incorrectly so net.

Thats upcoming and we're looking forward to that.

Great. That's helpful. Thank you. Thanks.

Thanks, Brian.

Your next question comes from the line of Jason J Barry for.

From Bank of America. Your line is open.

Hi, guys.

For taking my questions.

Yes, I guess Derek.

Kind of curious to get your thoughts.

And Jones update on parts of the bulbs kind of coming out of the tobacco.

Guiding to I think of 40 or 50% year over year decline in revenue.

Just how investors should be thinking about sort of drugs coming out of this with apples phase, where there's maybe a better price point.

Just kind of trying to reconcile that versus the current consensus where there's growth on year, three and year for of the launch, but just wondering how to think about that price reset time on that.

<unk> talked about in the past the and then.

Second question is just curious about.

Thinking about the parts of the Bill of launched a little bit more closely wondering if you of any perspective on why the.

For the uptake was low with large dialysis organizations versus small dialysis organizations.

Is there a concern amongst the <unk>. The once you start using the medications, it's difficult to kind of pull back on the copay component of this could be simple in that the LDL typically absorbed so wondering if you can comment on most of the dynamics as we start to think about the commercial here. Thanks.

Yeah. Thanks, Thanks, Jason I mean, I think the first thing to say right upfront that you're well aware of Jason the that parts of the visit.

Entirely different class here and directed at of an entirely different issue.

Associated with dialysis patients for which there are existing alternatives already out there, including non Jess on drugs since the par. So I think that has a lot to do with the point, you're raising on revenue decline as the availability of of.

A number of alternatives out there that are quite frankly, much cheaper than price a bit was that will not be the case with pursuit of as you know of breakthrough drugs really going on in the first drove the approved for for <unk> Pruritus and there are no tenants of sort of applications certainly nothing we've seen various day.

There's been an RCT in that patient population, so I think it's.

Quite a bit of apples and oranges there in terms of <unk>.

In terms of the price of those.

Change post the DARPA.

Yes.

Your question related to the use of L.

L deals versus the more mid.

The mid size and independent.

Dialysis organizations.

Again, I think per se, but it might be.

The Saturday has specific issues related to those.

Can't really speak to the smaller organizations, we don't really have their view, but as you know we've worked for us with Fresenius now.

For a couple of years and we know the enthusiasm that.

The if we laid and the need for this.

The therapeutic for their patients and as you know, they're all striving as part of the assessment on reimbursement to improve patient standard of care.

And they see this as the huge unmet need in the very keen.

Get involved in.

Moving the drug along so.

That doesn't answer the question to the independents and the differentiation there with parts of it but we know from our experience with the large.

All of this organization they are very keen to get and with Crisil.

And use the drug and of.

Of course, the database is related to credit.

Prevalence of pruritus within their within their patients.

Okay, great. Thanks, so much for the.

You're still on sites.

Great. Thanks, Jason Thanks for the questions.

Again, I would like to remind everyone in order to ask your question Press Star then the number one on your telephone keypad again Thats star one on your telephone keypad.

Your next question comes from the lineup of Joseph Stringer from Needham <unk> Company. Your line is open.

Hi, everyone. Thanks for taking my questions.

I was wondering if you could detail.

And the.

We're all for sleep.

For atopic dermatitis.

You see that will begin to the current.

Treatment paradigm and then.

The follow up for for the upcoming Phase II readout.

Is that fair.

Think about comparisons to some of the phase two.

The data from the oral JAK in terms of.

And our S reduction and also.

For a person on Egypt.

Of response rates. Thank you.

Great. Thanks, Thanks, Joe and congrats on the the new possession of Needham.

Yeah. So so.

When we think about atopic dermatitis.

Of course pruritus is the defining symptom for the disorder.

And the and that level of pruritus high level of pruritus.

Our cards really regardless of the degree of pathophysiology there so.

We can recruit and have done.

In our clinical trials patients with very high levels of pruritus is the only qualifying this moderate to severe whether they have mild to moderate pathology associated with the retail the dermatitis R&D moderate to severe pathology. So so this is a triangle the symptom across the whole spectrum of atopic.

Dermatitis todays therapeutics for the mild to moderate.

Really confined to topical medications.

On the medication has been developed in the topics that are beyond top of the goals of course, we have to pitch them accretive does that IL four IL 13.

Biologic and we of the JAK inhibitors as you indicate coming through are really targeting the moderate to severe pathology, that's there of niche.

The where they're going to be reimbursed and thats, where dermatologist of most likely be willing to use those.

And the accommodate the associated safe.

Safety risks that are going to ensue from both biologics and particularly jacks.

Those molecules coming through are really focused on about 20% roughly of the U S. Atopic dermatitis population pursue of on the other hand, we see positioned as being broadly applicable from mild to severe pathology, so much broader applicability than frankly, we see.

Particularly on the mild to moderate population is being a candidate for first line therapy. There maybe after some topical usage or in combination with the topical in the moderate to severe range again, I think it could be mono therapy for those patients.

Also.

Theoretically combined with any other modalities biologics for JAKKS.

For the more severe.

And as you know and we've talked about a number of times of there's there's no active metabolites for this drug is excreted whole via the kidney.

Theres no potential for drug drug interaction, we can see the Houston combinations with any other classes of medications so that type of we see it.

Being positioned as a much broader applicability potential fresh length of RFP for the whole of the a D a pop.

Populations and then getting to the <unk> readout, yes, we will be I think.

We've discussed this before the.

You know on the dermatological situation.

Certainly dogma had the Derm division at a four point responder analysis would be the appropriate.

Registration endpoint and we're certainly looking at that as one of our major endpoints and the atopic Derm trial on as you know we designed our interim analysis focused on the four point as well as I mean in our S change from baseline. So so we are looking at that readout in terms of.

Level of the response.

I think the.

I think the peg <unk> is in the 40% responder rate some of the jacks are a little higher but really only at the very highest dosages for those compounds. The may creep into the 50%. So a win for us is the.

Separation from placebo.

That's our primary aim here.

And again this is going to of entirely different profiles, so we'd like to see a nice appropriate biological window here, but again, we're looking for orally available.

Well tolerated.

The medication, which is really.

Something that as you well know dermatologists are looking towards is the desire of profile for that patient population, so efficacy, but with improved safety is going to be the profile of that is going to win against <unk>.

Particularly jacks that are coming through for the moderate to severe population.

The does that help position, where we see this.

Joe.

Yeah, that's great. Thanks for the detail.

Thanks for the question.

Your next question comes from the line of David <unk> from Piper Sandler Your line is open.

Thanks, and sorry for my audio issues earlier, thanks for fitting me in.

So wanted to dig more deeply into the the atopic Derm study and just first question is just remind us about.

The extent to which patients are not allowed to be on any background medications whether their topical.

Stomach and just talk about that as part of the the inclusion exclusion criteria and then and then secondly to the extent that you have favorable data and that you do move into phase.

The phase three.

Just talk through debt.

The same topic, whether you expect youre going to have to include patients with some form.

The background medications as of as a form of sort of of real world design.

You will.

And then secondly, just more broadly on the phase III program in atopic derm.

Is it safe to assume that's going to be sort of two identically designed phase.

<unk> phase III trials of you're going to have to do more of long term safety work and just help us understand just sort of the rough contours of what do you think youre going to need to do there.

Yeah. Thanks, Thanks, David.

Yes.

I'm glad you're back on back on the line.

So in terms of the phase III design.

I'm hesitant to go too far into that as you know we haven't yet had the an end of phase two of them are waiting on.

Ah readout from our from our dose ranging trial. We have studied the thank you bet on prepare for that and we do see the normal.

The phase III program for chronic used drug and we are planning to simultaneous U S trials.

I can't tell you the ultimate size of those because I need my phase two data to.

If you look at effect size, there, but that's that's our thoughts on exposures that would be in line with the ICA ICH guidelines for chronic use medications.

That's the point we're not.

Again, I don't want to get into problems and not to do something.

Thanks for the action with the FDA.

At this point, we're not planning on on extensive.

Ah trials, including Covid.

Co administration of other medications and that might be something that comes up particularly with topical but at this point, we're not particularly planning on that.

And then I guess the easier.

Question for for you.

Your first the answer for your first question on on the Phase two design, yet, we wash and have washed.

These patients out of all medications.

As an entry criteria into the phase III trials. So that's really is the pure.

You know monotherapy trial.

With no no influence of background medications there.

And if anyone.

Debt to systemic.

Systemic risks you there they would be.

It would be dropped for.

The from the efficacy calculation for that trial, so that is going to be of pure <unk>.

Trial with no co medications there for the patient.

Okay, great. Thank you.

Thanks, David.

Your next question comes from the line of Ben Shim from Canaccord. Your line is open.

Hi, Thanks for taking my questions and for all of the details.

On the clinical development.

I just had a quick question.

Maybe you may not be able to answer this but what is your sense of.

Vaccine uptake amongst <unk>.

While center employees personnel and maybe perspectives.

Of course Super trial patients or even currently enrolled ones I'm just wondering if.

The increase supply of is expected to come on board over the next.

A few weeks.

Could be a tailwind for your expectations on enrollment.

Thanks, Dan.

Thank you right on your assumption that I'm not sure I can answer that question for you.

Not even sure we've looked at that.

The one metric.

Clinical trial size, so I really don't know what the the.

<unk> seen an uptick is at this point on our trials that may be something we learn at the end of the day for our ongoing trials, but I really don't have any data on non metric right now.

Okay.

Maybe a question for Tom.

Looking forward to commercialization.

What level of visibility what we have.

On the underlying IV for soup of sales, both U S and ex U S sites on us.

Standard we're going to be seeing profit share of revenue reported in the top line I'm, just wondering if theres going to the other.

From a tour of data available.

Sure. Thanks, Brent so.

Five for we'll be recognizing the topline revenue on their side for net sales will be recorded on their books, so there'll be visibility on that end and correspondingly.

Base of the profit share that we received back that will be recognized as revenue on our end.

So there'll be visibility into the revenue is based off of that mechanism.

Okay, great. Thank you very much youre welcome.

From.

Again for anyone who wants to ask questions. You May Press Star then the number one on your telephone keypad.

There are no more questions at this time, turning the call back over to Dr. Derek Chalmers.

Okay. Thank you. Thank you everybody for participating in the call today and also again like to thank the Cara team on.

Our study investigators and all of the patients.

Continue to participate in our ongoing clinical trials and we look forward to updating you again.

Thank you very much and have a good night.

Ladies and gentlemen. This concludes today's call. Thank you again for your participation you may now disconnect have a great day.

[music].

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