Q3 2020 Concert Pharmaceuticals Inc Earnings Call

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Good morning, and welcome to concert Pharmaceuticals, third quarter 2020 Investor update.

Joining me this morning with prepared remarks are Roger today are president and CEO, Jim could sell out our Chief development Officer, and Mark Becker our CFO.

We will also be joined by Nancy Stuart Our Chief operating officer for the Q and a portion of the call.

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

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 FTC.

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.

Thank you Justine good morning.

On improving patient care with what we hope will be one of the first and potentially the best FDA approved treatment for alopecia Areata.

Let me turn now to our second clinical program seats.

CTP 692 for the juncture treatment of schizophrenia.

Im very pleased to report that despite coherent related disruptions and trial recruitment across the industry in September we successfully completed enrollment in the CTP 692 phase two trial.

Well ahead of the year end timeline, we projected spring after the Pandemics outbreak.

Right, a signifying that we believe that bringing an FDA approved medicine to patients with Alipay Shariati will help them thrive in potentially overcome the burden of the disease that patients experience on many aspects of daily life.

This unmet need for a treatment for Alipay Shariati is one reason why CTP 543 is designated in the FDA breakthrough therapy, and we are excited to be embarking on the phase three pivotal program.

23 positioning CTP 543 could potentially be one of the first FDA approved treatments for Alipay shariati.

We are very motivated and excited with the initiation of this phase three program to bring this new potential treatment to the Alipay shariati patient community.

In the realm of medical meetings and publications, we continue to engage with the treatment community about CTP 543, and needed progress and the treatment of allocation areata.

Error, whereby patients will have access to effective treatments.

Our efforts to support Al appreciate Areata awareness through the month of September which is its designated awareness month have also helped to put a spotlight on that on the disease and our work to develop a new treatment.

These efforts along with new findings as described in the paper I just mentioned continued to strengthen our involvement in the allocation Arianna community and show our commitment communicating about allocation Ariana as a serious medical condition.

Let me wrap up with a brief overview of our progress with CTP 692, our candidate for adjunctive treatment of schizophrenia.

For the phase two trial of CTP 672 in schizophrenia, our team rapidly developed and implemented strategies to minimize disruption in recruiting and enrolling patients in the trial.

I'm very pleased to say that enrollment is now complete we randomized 325 patients into the trial across 25 sites in the U.S.

CTP 692 represents an entirely new approach to potentially treat schizophrenia.

Disease that continues to have significant unmet needs for many patients.

As we continue our phase two trial of CPP 692 for schizophrenia and conduct our phase III trial CTV 543 in alopecia Areata.

General and administrative expenses were four 5 million during Q3 2020 compared to four $7 million for the same period in 2019.

Q3, 20 decrease is attributable to lower legal and professional fees.

Our net loss for Q3, 2020 was $18 $9 million or 60 cents per share compared to a net loss of $17.2 million or 72 per share during the same period in 2019.

Finally, we ended the third quarter of 2020 with $124.2 million in cash cash equivalents and investments.

Under our current operating plan, we continue to expect our cash to fund the company into the second half of 2021.

The team is executed well across both our programs and we are well positioned to advance the pipeline in 2021.

In the asphalt 20 primary endpoint, we were able to do that Howard and based on the phase two studies that we have conducted to date.

So so again, we're very well powered there.

90% or better range in terms of the data disclosures, there's no interim analysis plan for the studies.

But thrive a one our first study that we've initiated.

We'll report out.

Incomplete before the second study because there's going to be a lag between thrive a one and thrive age too. So we havent discussed in full details the disclosure of data, but they are more than likely will be reported out separately.

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It's free for the treatment of hair loss, including Alope Sherry auto.

Thank you that's helpful.

Sure you're welcome.

And our next question coming from you Wanna pay some Batman Uhm J P. M security shall I missed my Austin.

Hi, Thanks for taking the the questions a couple on C. T. P. 543. So so first of all can you know regarding the the ongoing Covid pandemic can you talk about mitigating factors you built into the study protocol for thrive to Minimise enrollment in trial conduct interruptions for example.

Program.

Anxiety and depression and of course, we know from the literature as well as our recent publication that appeared in the journal of investigative dermatology, where we were.

With some of the K wells in this space investigated through survey the burden of illness, and LTC ATA and we know that through that survey.

In guiding depression, and SEKCO social aspects of LTC area are prevalent in the population.

Great helpful and if I can just squeeze in a quick one on six nine too.

For the phase two population any comments on expectations for the number of prior and psychotic medicines. The patients will have been treated with and the study.

Sign a phase III program and bring our phase two data to the FDA in in phase two meeting. So once we have our data all wrapped up and.

Safety and efficacy data we will.

Plan on having an end of phase two meeting as soon as we can with the FDA.

Great. Thank you and then just one more quick one in terms of the data that was reported at.

There is a lot of consistency in the.

Demographics and baseline characteristics of of all our phase two studies and I think the shape of the curves for the two studies that looked that we showed for the 12 milligram dosing group look remarkably consistent and similar and then as we go into the open label extension study the highlight.

Of of that efficacy data was that it was it was stable or even improving as we showed with the 2003 data set more clearly so I think there was a lot of consistency there between the the the basic effects that we saw in the phase two studies as well as the consistency of those effects.

Married into the allele and now outwards up to another six months of dosing beyond the 24 week initial period.

Great. Thanks, appreciate the color and I'll hop back in the queue.

Sure. Thank you.

Thank you and our final question is from.

Sales at Mizuho. Your line is now open.

Good morning, and thanks for taking my question just two questions. The first one you guys you find 43.

Given the evolving competitive.

Okay great.

Would you share with your high level thinking about pricing.

I know, it's a couple of years down the road.

Thank you.

Helping to model out the.

The forecast and then secondarily, our CTP 692, Jim would you couldn't minders work.

And I'm not showing any further questions at this time I would like to turn the call back over to Justin Smith for closing remarks.

Thank you we'd like to thank everyone for joining us this morning, and we look forward to keeping you updated on all of our pipeline progress.

Those interested we will be participating at the Stifel and Jefferies healthcare conferences later this month and we hope we'll have the opportunity to meet with many of you. There. This concludes today's call. Thank you.

And Joe Linda Okay. So thank you for it go station you may now disconnect.

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