Concert Pharmaceuticals, Inc. (NASDAQ:CNCE) Q3 2019 Earnings Conference Call - Final Transcript

Nov 07, 2019 • 08:30 am ET


Concert Pharmaceuticals, Inc. (NASDAQ:CNCE) Q3 2019 Earnings Conference Call - Final Transcript


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Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the Third Quarter Update Call. [Operator Instructions] As a reminder, this conference call may be recorded.

I would now like to turn the conference over to Ms. Justine Koenigsberg, Senior Vice President of Corporate Communications and Investor Relations. Ma'am, please go ahead.

Justine E. Koenigsberg

Thank you. Good morning, and welcome to Concert Pharmaceuticals' Third Quarter 2019 Investor Update. Joining me this morning with prepared remarks are Roger Tung, our President and CEO, Jim Cassella, our Chief Development Officer, and Marc Becker, our CFO. We will also be joined by Nancy Stuart, our Chief Operating 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 risk factors can also 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.

Roger D. Tung

Thank you, Justin, and good morning.

In 2019, we have accomplished important progress in our pipeline, with strong results generated with both our proprietary candidates, CTP-543 for moderate-to-severe alopecia areata and CTP-692 for adjunctive treatment of schizophrenia.

We've been actively presenting both of these clinical programs at scientific and medical meetings this year and we're very pleased with the enthusiasm shown for both candidates results and their potential to address an important unmet needs for chronic diseases.

For CTP-543, we believe the Phase 2 results have set a new benchmark for clinical efficacy in the treatment of alopecia areata. In a moment, Jim will recap the results presented at EADV last month. With our Phase 2 results, we've identified two doses of CTP-543 with promising efficacy and tolerability profiles, both of which may be suitable for assessment in future trials. We also see some advantages of the higher dose, including faster onset and greater magnitude of effects. The program is progressing nicely, and we expect to advance CTP-543 into Phase 3 testing in 2020.

As a reminder, we are also conducting two-dose regimen studies, evaluating twice-daily versus once-daily dosing. Both of these studies are fully enrolled, increasing our patient database and helping us to define the characteristics of these doses and dose regimens of CTP-543. These data will be very helpful as we meet with FDA in an end of Phase 2 meeting next year.

As a reminder, we filed a notice of appeal with Federal Circuit Court challenging the PTAB's decision on the patentability of our CTP-543 composition-of-matter patents. In addition, we are actively pursuing other IP protection for CTP-543, including a pending application that's supported by an impressive Phase 2 results and several more applications in preparation. We hope to have more to say on this