Miragen Therapeutics, Inc. (NASDAQ:MGEN) Q3 2019 Earnings Conference Call - Final Transcript

Nov 07, 2019 • 04:30 pm ET

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Miragen Therapeutics, Inc. (NASDAQ:MGEN) Q3 2019 Earnings Conference Call - Final Transcript

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Presentation
Operator
Operator

Thank you for standing by. This is the conference operator. Welcome to the miRagen Therapeutics Third Quarter 2019 Earnings Conference Call. [Operator Instructions] And the conference is being recorded. [Operator Instructions]

I would now like to turn the conference over to Dan Ferry, Managing Director of LifeSci Advisors. Please go ahead.

Executive
Daniel Ferry

Thank you, and good afternoon, everyone. On the call today are miRagen's President and Chief Executive Officer, Bill Marshall; Chief Financial Officer, Jason Leverone; and Executive Vice President of Research and Development, Paul Rubin.

Before we begin, I would like to remind everyone that this conference call and webcast will contain forward-looking statements about the Company. These statements are subject to risks and uncertainties that could cause actual results to differ. Please note that these forward-looking statements reflect our opinions only as of the date of this call. We will not undertake an obligation to revise or publicly release the results of any revisions to these forward-looking statements in light of new information or future events. Factors that could cause actual results or outcomes to differ materially from those expressed in or implied by such forward-looking statements are discussed in greater detail in our most recent filings on Form 10-K and our other periodic reports on Forms 10-Q and 8-K filed with the SEC.

I would now like to turn the call over to Bill Marshall, President and Chief Executive Officer of miRagen. Bill?

Executive
William Stuart Marshall

Thanks, Dan. Good afternoon, everyone, and thank you for joining us for our corporate update call for the third quarter 2019. I'll provide updates for each of our three clinical stage product candidates before turning the call over to Jason to provide a review of our financial results for the quarter.

Starting with cobomarsen, which is currently being evaluated in three clinical trials for multiple indications including the SOLAR Phase II clinical trial for cutaneous T-cell lymphoma or CTCL. We've opened approximately 70% of the sites currently planned for the SOLAR clinical trial. The primary endpoint for the SOLAR trial is the objective response rate defined as a 50% or greater improvement in the severity of a patient's skin disease over the entire body with no evidence of disease progression in the blood, lymph nodes or viscera, maintained for at least four consecutive months. Progression-free survival is a secondary endpoint, and we plan to use patient-reported outcomes as additional secondary endpoints to monitor quality of life improvements.

Based on our discussions with the FDA, we believe that achieving the primary endpoint from the SOLAR trial could allow us to apply for accelerated approval of cobomarsen in CTCL in the United States. Today, we updated our guidance on when we expect to report primary endpoint data from this clinical trial from the first half of 2021 to the second half of 2021. Our decision to adjust our guidance today was based on longer-than-anticipated time to activate the number of sites to support our previous patient enrollment projections, resulting in slower-than-anticipated patient enrollment. While there are no guarantees,