Q2 2021 Concert Pharmaceuticals Inc Earnings Call

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Good day, and thank you for standing by and welcome to the concert Pharmaceuticals second quarter 2021 Financial result conference call. At this time, all participants on a listen only mode. After the speaker's presentation. There will be a question and answer session. Please be advised.

Today's conference is being recorded to ask a question. During this session you will need to press star 1 on your telephone if you require any further assistance. Please press star Zero I would now like the handler conference over to your speaker today Justine Koenigsberg. Please go ahead.

Good morning, and welcome to concert Pharmaceuticals second quarter, 2020 line Investor update like last quarter. 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 CTV side for 3 key highlights and then Marc Becker, our CFO will walk you through the second 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.

Last month, we had the opportunity to present findings from the ongoing C. T. P..543 open label extension study at second Jack inhibitors drug development sucked.

Currently over 100 patients have been dosed with C. T. P 543 for at least a year and half.

Importantly, a high percentage of eligible patients have elected to continue to participate in the extension study.

Treatment with C. T. P 543 in the study continues to be generally well tolerated with adverse events consistent with those recorded and <unk> phase 2 studies <unk>.

Importantly, salt scores assessing hair root growth were maintained or improved and the vast majority of alopecia areata patients who continued in the study.

C. T. P 543 has the potential to be a best in class treatments per alope Sherri on <unk> and remains the top priority for business.

Our team is focused on expeditiously executing the phase 3 thrive a clinical program Ms deep into planning for the regulatory pathway to N D a theirs.

There's an enormous need for an F. D. A approved treatment for alopecia Areata and we're proud that concert was 1 of the first indie industry to take notice of this important disease by advancing C. T. P 543.

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

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

Revenue was 32 million for the second quarter of 2021 due to the monetization of outstanding milestones under art 2017 asset sale to vertex we were happy to bring in its additional non dilutive capital and strengthen our balance sheet as we continue to advance C. T T..5 forty-three through it's day 3 program.

Research and development expenses for 22 million during the second quarter of 21 compared to 14.8 million during the same period in 2020.

Q2, 21 increase was primarily related to the ongoing C. T. P 543 phase 3 clinical program.

General and administrative expenses were 5.6 million during Q2.21 compared to $4.7 million for the same period. In 2020 Q2, 21 increase was primarily attributable to hire external professional service expenses and non-cash stock based compensation.

On net income for Q2, 21 was 5.4 million or 16 cents per share compared to a net loss of 13 million or 41 cents per share during the same period in 2020.

We ended the second quarter of 2021 with $122.4 million in cash and cash equivalents under our current operating plan, we expect our cash and cash equivalents to fund the company into the second quarter of 2022.

This concludes our prepared remarks, and we would be happy to address any questions.

And thank you as a reminder to ask a question you will need a price star 1 on your telephone so Jolly a question price the <unk>.

Please stay on by would compile the Q&A roster and our first question comes from Jason Butler from JMP Security. Your line is now open.

[noise] hi throw it for Jason Thanks for taking our questions. Just a couple of questions..1 on the thriving wanted 2 trials uhm sounds like enrollment is going fine you know they tried to find it any feedback from investigators.

Or the patient. So you can share just to characterize what they're seeing in the trial and I'm. Just wondering if you had any comment on the recent results from Pfizer.

With their drug reply hit me in the face to be 3 results that were recently announced thanks.

Oh, Thanks for the question Jim could you start off on that and I may try them. It afterwards sure. Yeah. So the you know the trials are ongoing so we really can't make any comments on on anything regarding the details of the trial, but the trial that both trials continues to <unk>.

Dress nicely with enrollment and we are on track as we projected with are expected completion dates in the.

Early next year for thrive a 1 in the second half price right away too.

As far as the.

I'd go ahead Roger of 20th.

No go on okay.

Okay. I think you know there wasn't really any data to speak of in the press release for <unk>. So it's really hard to determine what what they're seeing in that in that trial.

[noise], Yeah, I agree with that.

Thank you.

Day <unk> and our next question comes from Maury Ray Crock from Jeffries. Your line is not open.

Good morning, everyone. This is quite a thing on from Murray. Thank you for taking on question just to follow up on the 2 faced fees.

Just to focus its debt how do you put on snake thinking of any innovations to ethnic enrollment given the enthusiasm and study.

Jim I mean.

Yeah. So.

We have we've implemented all of the things that we need to do to keep enrollment going and the thrive program. So I think we are we are really.

Really pulling on all stops as we have been from the very beginning to make sure that we have patients enrolled in both studies on our on a timeline. It I think we're we're tracking.

Trials towards the completion dates that we projected.

Okay great.

Thank you for taking with share.

Thank you.

And again, ladies and gentlemen, if you have a question just star 1 again, if you'd like to ask a question that is star 1 and our next question comes from Bye Bye Yang from Me me do your.

Your line is not open.

Hi, Good morning. This is Alex on 40 say thanks for taking the question. So you were recently presented some long term data from CGP 543, where you showed from a safety standpoint stable hematology parameters over time I was wondering if you could help contextualize this data relative to what we know from.

Experience with other Jack inhibitors around hematology parameters and then just how do you see the overall safety profile 5.

543 relative to other Jack inhibitors.

Sure. Thanks, Alex Great question, because we know that Jack inhibitors, having known pharmacology profile I think what we've been seeing in what we reported in and the Jack Conference recently is that.

Keep parameters that we continue to monitor.

In the hematology side of things neutrophils platelets et cetera are all very stable as we look at longer term dosing I think this is a very important finding to be reported but also for us to be continuing to look at because I believe we have the longest term day to out there for Jack inhibitor coming from.

Controlled trial, so I think the fact that we're seeing stability of our hematology responses as we now go out and subjects you know over a year of.

Continuous dosing.

Is very good sign for for this product and I think it's going to be very important in our submission package as we have all these these long term studies this long term data.

That will be able to put in there. So I think the profile. We're seeing is is not inconsistent with what was expected for Jack inhibition, but I think the important thing is that the data shows that we have good stability.

<unk> of these parameters as we continued to dose for a long period of time.

Hi, This is Roger I just went ahead in that.

I agree with everything that Jim said this is really with respect to alopecia areata patients. Jack inhibition of course has been studied in other disease states for substantial periods of time and clinical trials, but we know that the pharmacology of Jack inhibitors and their effect on patients.

Both therapeutically and adverse effects are really associated with the underlying disease state of the patients. So we have studied CGP 543, P. Sherri occupations and reported as Jim indicated to what we believe is the longest term data in that patient population.

And are so far very pleased with so what we see in terms of safety versus ethics your profile.

And thank you.

And I am showing no further questions I would now like to turn on the call back to Justin Koenigsberg from closing remarks.

We'd like to thank everyone for joining us this morning, I mean, let's orange and continuing to keep you updated on our progress on in the meantime for our list about coming Investor confidence day. Please visit the event page within the investors section of our website. That's conclude today's call. Thank you.

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

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