Q1 2021 Concert Pharmaceuticals Inc Earnings Call

May 4, 2021

[music].

Good day and thank you for standing by welcome to the concert Pharmaceuticals first quarter 2021 financial results conference call. At this time all participants are another thing all of the mode. After the speaker's presentation. There will be a question and answer session to ask the question. During the session you want any of the press star one on your telephone.

One did you acquire any further assistance. Please press star Zero I would now like to hand, the conference over to your speaker today Justine Koenigsberg. Please go ahead.

Good morning, and welcome to concert Pharmaceuticals, first quarter 2021, Investor update our prepared comments today will be brief so we can jump right into the Q&A portion of the call Roger Tung, our CEO will provide the C T.

Five for three key highlights and then Marc Becker, our CFO Who'll walk you through the first quarter financials. We will then be joined by Nancy Stuart Our Chief operating Officer, and Jim Cassella, Our Chief Development Officer for the Q&A portion of the call.

As a reminder, today's discussion will include forward looking statements about our future expectations plans and prospects. These statements are subject to risks and uncertainties that may cause actual results to differ materially from those projected.

A description of these risks can be found in our most recent 10-Q filed with the SEC.

The forward looking statements speak only as of today's date and we assume no obligation to update any forward looking statements made on today's call with that I would now like to turn the call over to Roger.

Could you the students will.

We're committed to advancing the <unk> 543 through the phase III program and the two speed filing our NDA in early 2023.

We're very happy with the outcome.

Efficacy and safety profile of <unk> 543 has shown those for <unk>.

Based on the competitive data we've seen to date continue to believe that it may be best in class treatment for alopecia or Rialto currently in development.

Pleased with the overall progress of the <unk> 543 program, which is advancing as planned.

We're on track to initiate thrive 82 for a second phase III trial this quarter as projected.

The study will enroll approximately 440 patients with moderate to severe alopecia Rialto and as similar to try the one in design the phase.

His III data for expected next year.

As a reminder of robust clinical results, which have been presented to the number of medical meetings, including most recently data from our open label long term extension study showed that the GTP 543 treatment may change or improves here re growth beyond 52 weeks.

We plan to present, an update on the ongoing long term extension study during the second JAK inhibitors drug development summit from July 1st.

Additionally, looking at our Salt Twitchy analysis in the Phase two study, which is the primary efficacy endpoints can of our phase III trials, we saw statistically significant differences from placebo for the <unk> 543, eight milligram and 12 milligram twice daily cohorts of 24 weeks.

Specifically, 42% of patients treated with 12 milligrams of CTV 543 twice daily achieved an absolute salt score of less than or equal to 20.

And the eight milligram cohort 26 per cent of patients achieved an absolute salt score of less than or equal to 20 day.

Results for clinically meaningful.

Based on the data presented to date from interest response for trials. We believe core findings represent the most robust efficacy results of any compound being developed to treat alopecia area of it.

A recent epidemiological assessment of alopecia Areata day in the U S indicates that between 700001 6 million patients currently have the disease with upwards of 40 percentage of those patients suffering skull pair of loss of 50% or greater.

Becoming increasingly widely recognized the alopecia areata is an important medical condition with no approved treatment and in many patients exert significant emotional and psychological impact, including depression of or anxiety and is associated with other comorbid autoimmune conditions.

Theres, an enormous need for an FDA approved treatment and we're proud the concert was one of the first in the industry to take notice of this important disease by advancing CGP $5 43.

We continue to push forward its development with the goal to file our NDA in early 2023.

For the immediate future, we intend to invest for resources in advancing the <unk> 43.

Patients with alopecia area other have waited a long time for an effective treatment for it.

Developing something that we believe will be clinically meaningful to patients and expect to continue to be a major force in the field.

Let me pause here and turn the call over to Mark.

Thank you Roger as I review, our first quarter 2021 financial results. Please reference the financial tables found in today's press release.

Research and development expenses were $18 5 million during the first quarter of 2021 compared to $14 million during the same period in 2020 the.

The Q1 'twenty, one increase was primarily related to the ongoing the <unk> $5 43 phase III thrive a clinical program.

We expect R&D expenses to increase as we initiate our second phase III trial for <unk> 543 of this month.

General and administrative expenses were $5 5 million during Q1, 'twenty, one compared to $4 7 million for the same period in 2020.

The Q1 'twenty, one increase is attributable to higher external professional service expenses and noncash stock based compensation.

Net loss for Q1, 'twenty, one was $22 7 million for 67 per share compared to a net loss of $20 5 million or <unk> 70 per share during the same period in 2020.

Finally, we ended the first quarter of 2021 with $111 8 million in cash cash equivalents and investments.

Under our current operating plan, we expect our cash cash equivalents and investments to fund the company through 2021. This concludes our prepared remarks, and we would be happy to address any questions.

Thank you as a reminder to ask a question you want any of the press star one on your telephone to withdraw your question first of the pound key please standby, while we compile the Q&A roster.

Our first question comes from one of your Raycroft with Jefferies. Your line is now open.

Hi, Good morning, everyone. Thanks for taking my questions first one that I wanted to ask on it is just with recruitment for the first 543 phase III.

Particularly on top of COVID-19, just if you can provide any more specifics on how it's going and how is site activation is going from the U S of internationally.

Yeah.

Sure Hi, Marty this is Jim So a great question, we are doing very well the.

The trial is ongoing we have our U S and Canadian sites are all doing very well and we brought on the European side. So I think given the experience we had last year running trials on their COVID-19, we learned a lot we have a.

<unk> team that has now experienced under these conditions.

I think things are going according to plan.

And just as a reminder, we are.

Going to be kicking off our second phase III study as planned and this quarter.

Got it and just of the.

The structure, sorry, I apologize I dropped off the call.

Alright.

Yeah. First question was just on the first phase III and how enrollment is going for that one and I guess your comments, Jim as a follow up I'm just wondering for the second.

<unk> phase III as you get that started what the strategy is there for activating sites and die.

Enrolling patients internationally, if theres any more specifics for you guys can dimension on that.

Yeah, no. It look at the very competitive space out there right now and we have our sites selected.

Things are progressing very nicely.

We have.

Good data that drives our our enrollment and we also have an ongoing open label extension study, which has been very very useful in our recruitment activities because patients know that.

Even though we have placebo controlled trials that we were able we are able to flip people into the open label extension study, where they will go on active treatment. So I think we've optimized all of our trial designs and our program to really facilitate enrollment into the program. So running these trials simultaneously.

We don't believe is going to be any issue.

Got it Okay and also wanted to ask a question about cash runway and financing strategy over the next 12 to 18 months. Just wondering if you guys could talk about scenarios like milestone payments from partners or potentially how the trial delay could impact your decisions going forward.

Mark can you take that.

Sure Yes. Thanks, Marty So look we're of late stage company now we're in phase III, We've got the second phase III about to kick off and so.

No doubt, we will we'll have to bring in capital there is the capital need.

And so we do have cash for the end of this year, and we're always assessing dilutive and non dilutive opportunities.

We also have an ATM out there so we're exploring all of those options as we speak.

Got it Okay and last quick question just on the DDI studies that are being conducted alongside the phase III as part of the normal NBA packaging and labeling support just wondering if you can comment on the progress with those.

Sure Jim again, so yeah those are the.

Of those theyre going to be studies that will will support the NDA things are moving very nicely there.

We have a great early development team.

In our clinical team and and those studies are progressing very nicely. We will have a number of those that will support the NDA and we are on track to have all of those completed by the time we file.

Great. Okay. Thank you for taking my questions.

Sure thing.

Thank you. Our next question comes from Jason Butler with JMP Securities. Your line is now open.

Hi, Thanks for taking the questions.

First first one just a quick one on the second.

Phase III trial, you're about to start can you I know you said that Roger they were similar can you just remind us of any.

The meaningful differences in the trial design and then also can you talk about the overlap in an essentially an enrollment sites between the two studies.

Well I'll start and then kick of kick it over to Jim Thanks, very much for the question Jason.

So the the endpoints will be the same for the two studies the second one will be smaller.

Because we will have enough patients who of will have been exposed to CGP $5 43 to produce what we believe will be of quite robust safety database.

And it will also be more there will be more sites in Europe for the second study and the Jim do you want to comment further.

No that's basically right I mean, we we have picked centers that.

We will meet our enrollment criteria. So in some cases, we have high enrolling centers that are capable of participating in more than one study and the other cases, we have the center is just the responsible for one study. So I think part of that process of selecting our centers is really.

Geared towards being able to run both studies efficiently.

As Roger said, we are taking opportunities to run.

Runs of more European centers for the second phase III trial as you know.

Theres not a lot of going on in Europe. At this time, so there's a lot of fresh patients there.

Great.

Helpful. And then second question for me just can you give us.

Any update on the the.

P Tab review of the 659 pattern I think you'd said last quarter that there was the potential for a for a post grant review in mid May is that still possible.

And then what would be the next steps following that thanks.

Sure. So pizza hut is currently reviewing the the P. G R.

Petition that insight had filed against the 659 patents.

Dave They filed the initial petition and we have responded to it there's been.

Traditional back in force on that.

We expect that they should have the decision on whether or not to initiate a piece of your review.

Around the middle of this month, so if the do decides to initiate that review our expectation is that it will be.

Conductors, Inc completed within the calendar year of the initiation of that time.

We believe that we have good arguments for why the.

The argument petition by.

Insight is.

A really non powered so our hope is that it will not be instituted.

Even if it is we think that that's the strong patent the.

Will survive any challenges.

Okay, great helpful. Thanks for taking the questions.

Great. Thanks.

Thank you. Our next question comes from Esther Hong with Dan. Your line is now open.

Hi, Good morning, two questions from the first can you speak about the competitor treatments in development for.

For Alopecia Areata and then second separately regarding additional pipeline opportunities can you speak about any clinical or preclinical results for <unk> five for three and other therapeutic areas. Thanks.

Hi, Esther so I'll take the first crack at that and it's true.

Jim wants to follow up the welcome his thoughts on that.

The only the <unk>.

On the entities, which currently are in development that have any clinical data associated with them are very sick and.

A good citizen of.

The the data for.

For those has been available for for a while.

Most recent release has been by by Lilly earlier this year I think.

Might actually the P. This months they had released phase III data on <unk>.

And the.

The data that they have indicates that there is statistically significant responses at the salt 20 score.

But we feel that based on the data that we've seen across multiple phase two studies with TTP 543.

540, threes results called for more robust than they are sitting there.

Both of the two milligram and the four milligram.

Joe strength.

So specifically what.

What really indicators is in that the pre the a one in the AA two studies.

They were seeing between 33 and 35% or so.

All of 'twenty response at the at.

At the four milligram level and between 19 and 22% of response of the two milligram level and those are both the 36 weeks.

In contrast, our responses.

The 24 weeks so it's significant.

And instantly earlier timeframe.

Or eight milligram and 12 milligram twice daily doses.

26, 42% of responses respectively.

So I'll just leave it at that.

For rootless citizen of Oh, we are awaiting the O E.

The readout from their phase two three study and so we don't have the appropriate late stage comparison there yet.

Great that's very helpful.

And then just the additional pipeline opportunities and you know of C. T P. Five for three beyond autoimmune disorder.

Right, so clearly with the E check.

Jack one two and chip to a profile of activity of <unk> 543 is expected to be.

Active in additional disease states beyond the alopecia Areata as you noted.

We have really focused our efforts to date on the treatment of alopecia or you're out of it. So we don't have from.

Additional disease state information to share at this time.

We have spent quite a bit of time looking at follow on indications.

The indications for 543 and it's identified.

A very short list of indications, which would be of high interest to us as we go forward, but true for.

For for competitive reasons, we're really not.

When you talk about those at the present time.

Okay got it. Thank you so helpful.

Yes, Thanks history.

Thank you as a reminder to ask the question you will need to press star one on your telephone.

Our next question comes from TSA Yang with Mizuho Securities. Your line is now open.

Hi, good morning, and thanks for taking my question I'm just a question on the mm Jack Channel wondering if you could comment a bit of how you think about the safety of JAK inhibitors in channel versus C. T. P 543.

The recent developments around safety in the space.

When you think about the differentiation on the.

Among the key.

Some pounds versus a potential class effect.

Hi, Jason Thanks for the question.

So with respect to JAK inhibitors, it's clear that there are both class effects associated with JAK inhibitors to date.

There appear to be the class class effects and there are also idiosyncratic effects with the individual compounds as you.

One would expect to see with small molecule inhibitors that may be related to either off target effects or differences in terms of the Roche.

Relative inhibition of different jacks debt.

The deferred for molecule to molecule.

We think the FTA is clearly trying to understand the relative similar cheese and differences and we have seen now a couple of.

A couple of from Paducah dates that have been pushed back so the net ski can get additional information and better assess those aspects.

We think with respect to.

JAKKS there well first of all of their there are numerous checks that are.

JAK inhibitors that are approved now across multiple indications and it's clear that day.

The great utility and it will continue to be used in the future the specifics around the classes and the the individual compounds.

<unk> will be addressed.

Over the course of the next.

Probably half of year is FTA assesses its information and of <unk>.

Of course individual compounds will be assessed over time as their day to becomes.

Clarified in a larger population.

Of our view is that this will largely be the case by case.

Situation of where the.

Safety and efficacy profiles of compounds in the individual disease States will.

It will be addressed and assessed by play F T H.

One of the of the.

Facts of LNP share reata is debt.

Some of the mechanisms of action of of treatment of other disease states of other inflammatory disease states are not as effective in alopecia areata as they are in for instance.

Rheumatoid arthritis.

So the other.

The the choices of compounds that will be effective in alopecia areata and for the foreseeable future will be be fairly limited.

Check inhibitors have shown the greatest efficacy to date that im aware of in the treatment of alopecia Areata.

Versus.

The other modalities and so its our expectation that.

The risk benefit profile will skew favorably for the use of JAK inhibitors.

And of course, as we've discussed before with respect to <unk> 543. So.

We've been very happy with the overall safety profile of the compound and are developing a quite substantial safety database with long term exposure to 543 that will be able to price provide the FTA at the time of our NDA submission.

Oh, Thank you very helpful.

Thank you I'm not showing any further questions at this time.

I would now like to turn the call back over to Justin current expect for closing remarks.

Thank you joelle and we'd like to thank everyone for joining us. This morning, and we look forward to keeping everybody updated on our progress for a list of upcoming Investor conferences. Please visit the events page within the Investor section of our website. This concludes today's call. Thank you.

This concludes today's conference call. Thank you for purchase and you may now disconnect.

[music].

If you acquire any further assistance. Please press star Zero I would now like to hand, the conference over to your speaker of today.

Koenigsberg. Please go ahead.

Yeah.

Good morning, and welcome to concert Pharmaceuticals, first quarter 2021 investor update our prepared comments today will be brief so we can jump right into the Q&A portion of the call Roger Tung, our CEO will provide the C. T P. Five for three key highlight.

And then Marc Becker, our CFO Who'll walk you through the first quarter financials. We will then be joined by Nancy Stuart Our Chief operating Officer, and Jim Cassella, Our Chief Development Officer for the Q&A portion of the call.

As a reminder, today's discussion will include forward looking statements about our future expectations plans and prospects.

The statements are subject to risks and uncertainties that may cause actual results to differ materially from those projected debt.

Scripps one of these risks can be found in our most recent 10-Q filed with the SEC any forward looking statements speak only as of today's date and we assume no obligation to update any forward looking statements made on today's call with that I would now like to turn the call over to Roger.

Could you the steam.

We're committed to advancing the <unk> 543 through the phase III program and it's the spade filing our NDA in early 2023.

We're very happy with the ask the efficacy and safety profile of TTP 543 has shown the thus far and based on the competitive data. We've seen to date continue to believe that it may be best in class of treatment for alopecia or Rialto currently in development.

We're pleased with the overall progress of the <unk> 543 program, which is advancing as planned.

We're on track to initiate thrive <unk> two our second phase III trial. This quarter is projected at.

The study will enroll approximately 440 patients with moderate to severe alopecia area out of.

And as similar to try a one in design the phase.

MS III data for expected next year.

As a reminder of robust clinical results, which have been presented and the number of medical meetings, including most recently data from our open label long term extension study showed that <unk> 543 treatment maintains or improves here re growth beyond 52 weeks.

We plan to present, an update on the ongoing long term extension study during the second JAK inhibitors drug development summit from July one.

Additionally, looking at our Salt Twitchy analysis in the Phase II study, which is the primary efficacy endpoint in our phase III trials, we saw statistically significant differences from placebo for the CGP 543, eight milligram and 12 milligram twice daily cohort at 24 weeks.

Specifically, 42% of patients treated with 12 milligrams of <unk> 5000, <unk> twice daily achieved an absolute salt score of less than or equal to 20.

And the eight milligram cohort 26 percentage of patients achieved an absolute salt score of less than or equal to 20 <unk>.

These results for clinically meaningful.

Based on the data presented to date from interest Responser trials.

The leap or findings represent the most robust efficacy results of any compound being developed to treat alopecia areata.

A recent epidemiological assessment of alopecia Areata day in the U S indicates that between 700001 6 million patients currently have the disease with upwards of 40% of those patients suffering skull pair of loss of 50% or greater.

It's becoming increasingly widely recognized that I'll. Appreciate the reality is an important medical condition with no approved treatment and in many patients exert significant emotional and psychological impact, including the compression of Orange <unk> and is associated with other comorbid autoimmune conditions.

The enormous need for an FDA approved treatment and we're proud the concert was one of the first in the industry to take notice of this important disease by advancing <unk> 543.

We continue to push forward its development with the goal to file our NDA in early 2023.

For the immediate future, we intend to invest our resources in advancing CGP flow 43 per.

Patients with alopecia area other have waited a long time for an effective treatment for it.

All the things something that we believe will be clinically meaningful to patients and expect to continue to be a major force from the field.

Let me pause here and turn the call over to Mark.

Thank you Roger as I review, our first quarter 2021 financial results. Please reference the financial tables found in today's press release.

<unk> and development expenses were $18 5 million during the first quarter of 2021 compared to $14 million during the same period in 2020 for.

The Q1 'twenty, one increase was primarily related to the ongoing the <unk> 543 phase III thrive a clinical program.

We expect R&D expenses to increase as we initiate our second phase III trial for <unk> 543 of this month.

General and administrative expenses were $5 5 million during Q1, 'twenty, one compared to $4 7 million for the same period in 2020.

The Q1 'twenty, one increase is attributable to higher external professional service expenses and noncash stock based compensation.

Net loss for Q1, 'twenty, one was $22 7 million for 67 per share compared to a net loss of $20 5 million or <unk> 70 per share during the same period in 2020.

Finally, we ended the first quarter of 2021 with $111 8 million of cash cash equivalents and investments.

Thank you as a reminder to ask a question you will need the press star one on your telephone to withdraw your question press the pound key please standby, while we compile the Q&A roster.

The first question comes from Maury Raycroft of Jefferies. Your line is now open.

Hi, Good morning, everyone. Thanks for taking my questions first one that I wanted to ask that is just with recruitment for the first five three phase III.

Particularly on top of the COVID-19 just if you can provide any more specifics on how it's going and how is site activation is going in the U S and internationally.

Yeah.

Sure Hi, Marty this is Jim.

So great question, we are doing very well the.

The trial is ongoing we have our U S and Canadian sites are all doing very well and we brought on the European side. So I think given the <unk>.

<unk>, we had last year running trials on their COVID-19. We've learned a lot we have a great team that has now experienced under these conditions. So I think things are going according to plan.

And just as a reminder, we are.

Going to be kicking off our second phase III study as planned and this quarter.

Got it and just the the.

The structure, sorry, I apologize I dropped off the call.

Alright.

Yes first question was just on the.

The first phase III and how enrollment is going for that one and I guess your comments, Jim as a follow up I'm just wondering for the second.

<unk> phase III as you get that started what the strategy is there for activating sites and die.

Enrolling patients internationally, if theres any more specifics for you guys can mention on that.

Yeah No look.

At the very competitive space out there right now and we have our sites selected things are progressing very nicely.

We have.

Good data that drives our our enrollment and we also have an ongoing open label extension study, which has been very very useful and our recruitment activities because patients know that even though we have placebo controlled trials that we were able we are able to.

The flip people into the open label extension study, where they will go on active treatment. So I think we've optimized all of our trial designs and our program to really facilitate enrollment into the program. So running these trials simultaneously. We don't believe is going to be any issue.

Mark can you take that.

Sure Yes. Thanks, Marty So look we're of late stage company now we're in phase III, We've got the second phase III about to kick off and so.

No doubt, we will we will have to bring in capital areas of capital need.

And so we do of cash through the end of this year, and we're always assessing dilutive and non dilutive opportunities.

We also have an ATM out there so we're exploring all of those options as we speak.

Sure Jim again, so yeah those.

Of those theyre going to be studies that will will support the NDA things are moving very nicely there.

We have a great early development team.

Great. Okay. Thank you for taking my questions.

Sure thing.

Thank you. Our next question comes from Jason Butler with JMP Securities. Your line is now open.

Hi, Thanks for taking the question.

The first first one just a quick one on the second.

Phase III trial, you're about to start can you.

And then you said that Roger they were similar can you just remind us of any.

Meaningful differences in the trial design and then also can you talk about the overlap in an essentially an enrollment sites between the two studies.

Well I'll start and then kick of kick it over to Jim Thanks, very much for the question Jason.

So the endpoints will be the same for the two studies the second one will be smaller.

Because we will have enough patients who will have will have been exposed to <unk> 43 to produce what we believe will be a quite robust safety database and it will also be more.

There will be more sites in Europe for the second study and the Jim do you want to comment further.

Yeah, No that's basically right.

We have picked centers that.

We will meet our enrollment criteria. So in some cases, we have high enrolling centers that are capable of participating in more than one study and the other cases, we have the.

Of the centers just responsible for one study so I think part of that process of selecting our centers is really geared towards being able to run both studies efficiently.

And as Roger said, we are taking opportunities to.

Run some more European centers for the second phase III trial as you know the.

Theres not a lot of going on in Europe. At this time, so there's a lot of fresh patients there.

Great.

Helpful. And then second question for me just can you give us any update on the the.

P Tab review of the $6 nine pattern I think you had said last quarter that there was the potential for a for a post grant review in mid May is that still possible.

And then what would be the next steps following that thanks.

Sure. So pizza hut is currently reviewing the the PCR.

A petition that insight had filed against the 659 patents.

They've they filed the initial petition and we have responded to it there's been.

Additional back in force on that.

We expect that they should have the decision on whether or not to initiate a P. G of our review.

Around the middle of this month, so if the.

<unk> decides to initiate the review our expectation is that it will be.

Conductors, Inc completed within the calendar year of the initiation of that time.

We believe that we have good arguments for why the.

The argument petition by.

Insight is.

A really non powered so our hope is that it will not be instituted but even if it is we think that that's the strong patent the.

Surviving the challenges.

Okay, great helpful. Thanks for taking the questions.

Great. Thanks.

Thank you. Our next question comes from Esther Hong with band back. Your line is now open.

Hi, Good morning, two questions from the first can you speak about the competitor treatments in development.

For Alopecia Areata and then second separately regarding additional pipeline opportunities can you speak about any clinical or preclinical results for Cte high for three and other.

Other therapeutic areas. Thanks.

Hi, Alastair so I'll take the first crack at that and.

Jim wants to follow up the welcome his thoughts on that.

So the only.

The only entities, which currently are in development that have any clinical data associated with them are very sick and.

The citizens.

The the data.

For those who has been available for for a while.

Most recent release has been by by Lilly earlier this year I think.

Might actually the P. This months they had released phase III data on <unk>.

And the.

The data that they have indicates that there is statistically significant responses at the salt 20 score.

But we.

We feel that based on the data that we've seen across our multiple phase two studies with <unk> 543.

We believe that 500 threes results for more robust than there are certain of.

At the two milligram and the four milligram.

Joe strength.

So specifically what some.

What really indicators is in that the pre the a one and two studies.

They were seeing between 33 and 35%.

20 response at the.

At the four milligram level and between 19 and 22% response of the.

Two milligram level and those are both the 36 weeks.

In contrast, our responses and measured at 24 weeks so it's significant.

Instantly earlier timeframe.

And Ed or eight milligram and 12 milligram twice daily doses.

26, and 42% per of responses respectively.

So I'll just leave it at that.

For.

Rootless sit in the hall.

We are awaiting the call.

The readout from their phase two three study.

So we don't have the.

Procreate late stage comparison, there yet.

Great that's very helpful.

And then just the additional pipeline opportunities.

End of <unk> five for <unk> beyond autoimmune disorder.

Alright, so clearly with the E jet.

Jack one two and tick too.

Profile of activity of <unk> 43 is expected to be active in additional disease states beyond the alopecia Areata as you noted.

We have really focused our efforts to date on the treatment of alopecia or you're out of it. So we do have some.

The additional disease state information to share at this time.

We have spent quite a bit of time looking at kind of follow on indications.

Indications for five three and it's identified.

Short list of indications, which would be of high interest to us as we go forward, but true.

For for competitive reasons, we're really not.

When you talk about those at the present time.

Okay got it. Thank you so helpful.

Yes, Thanks history.

Thank you as a reminder to ask the question you wont need the press star one on your telephone.

Our next question comes from TSA Yang with Mizuho Securities. Your line is now open.

Hi, good morning, and thanks for taking my question.

Just a question on the.

Jack Channel wondering if you could comment a bit of how you think about the safety of JAK inhibitors in general versus <unk> 43.

The recent developments around safety in the space.

Do you think about the differentiation.

Among these compounds versus a potential class effect.

Hi, Jason Thanks.

Thanks for the question.

So with respect to JAK inhibitors, it's clear that there are both a class effect associated with JAK inhibitors to date.

There appear to be the class class effects and there are also idiosyncratic effects with the individual compounds as one would expect to see with small molecule inhibitors.

May be related to either off target effects.

The differences in terms of the.

Relative inhibition of different jacks debt.

The deferred from molecule to molecule.

We think Thats FTA is clearly trying to understand the relative similar cheese and differences and we have seen now a couple of.

A couple of from Paducah dates that have been pushed back.

So the <unk> can get additional information better assess those aspects.

We think with respect to Hum.

JAKKS there well first of all of their there are numerous checks that are.

JAK inhibitors that are approved now across multiple indications and it's clear that day.

Have great utility and it will continue to be used in the future the specifics around the classes and the the.

The individual compounds I think will be addressed.

Over the course of the next.

Probably half of the year as FTA and sensitive information and.

And of course individual compounds will be assessed over time as their day to becomes.

Clarified in a larger population.

Our view is that this will largely be the case by case.

Situation of where the.

Safety and efficacy profiles of compounds in the individual disease States will.

It will be addressed and assessed by the FTA.

One of the the.

Facts of alopecia reata is debt.

Some of the mechanisms of action of of treatment of other disease states of other inflammatory disease states are not as effective in alopecia areata as they are in for instance.

The rheumatoid arthritis.

So the.

The choices of compounds that will be effective in alopecia order for the foreseeable future will be fairly limited.

<unk> inhibitors have shown the greatest efficacy to date that im aware of in the treatment of alopecia Areata.

Versus.

Other modalities and so it's our expectation at.

The risk benefit profile will skew favorably for the use of JAK inhibitors.

And of course, as we've discussed before with respect to <unk> 543 itself.

We've been very happy with the overall safety profile of the compound and are developing a quite substantial safety database with long term exposure to $5 43 that will be able to price provides the FTA at the time of our NDA submission.

Oh, Thank you very helpful.

Thank you I'm not showing any further questions at this time.

I'd now like to turn the call back over to Justine current expect for closing remarks.

This concludes today's conference call. Thank you for purchase and you may now disconnect.

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