ImmunoGen, Inc. (NASDAQ:IMGN) Q2 2020 Earnings Conference Call - Final Transcript
Jul 31, 2020 • 08:00 am ET
Good morning, and welcome to ImmunoGen's Second Quarter 2020 Financial and Operating Results Conference Call. Today's conference is being recorded.
I'd like to turn the call over to Courtney O'Konek, Senior Director of Corporate Communications and Investor Relations. Please go ahead.
Good morning, and thank you for joining today's call. Earlier today, we issued a press release that includes a summary of our recent progress and second quarter 2020 financial results. This press release and a web stream of this call can be found under the Investors & Media section of our website at immunogen.com.
With me today are Mark Enyedy, our President and CEO; Anna Berkenblit, our Chief Medical Officer; and Susan Altschuller, our Chief Financial Officer.
During today's call, we will review key accomplishments for the business over the last three months, our financial results and upcoming milestones. During the discussion, we will use forward-looking statements, and our actual results may differ materially from such statements. Descriptions of the risks and uncertainties associated with an investment in ImmunoGen are included in our SEC filings.
And with that, I'll turn the call over to Mark.
Thanks, Courtney. Good morning, everyone. And thank you for joining us today. Despite the challenges of operating in the COVID-19 environment, our performance in the second quarter was marked by sound execution, key data presentations and important regulatory milestones. Our highest priority for the business is the completion of the pivotal studies from mirvetuximab and we are actively enrolling patients in both SORAYA and MIRASOL. Like other companies, however, we experienced slower-than-anticipated site initiation for these studies during the second quarter.
With conditions improving, particularly in Europe, we estimate a limited six week to eight week delay in reporting top line results for SORAYA, and now expect a readout to be in Q3 2021 versus our previous guidance of mid-2021. That said, given that large portions of BLA are already complete, we continue to anticipate filing for accelerated approval of mirvetuximab in the second half of 2021. With an earlier start and longer lead time, MIRASOL remains on track for both top line data and submission of a supplemental BLA.
Beyond the initial approval for mirvetuximab, we are considering multiple options for label expansion. To this end, we presented encouraging data from the FORWARD II Avastin expansion cohort in a virtual oral presentation at ASCO. These data demonstrate the potential of mirvetuximab to serve as the combination agent of choice regardless of platinum status and thereby meet the needs of a broader patient population within recurrent ovarian cancer.
Moving to our earlier stage programs, we are pleased to share with you this morning that EMA's Committee for Orphan Medicinal Products has adopted a positive opinion to grant IMGN632 orphan drug designation for the treatment of BPDCN and then FDA has accepted the IND application for our first-in-class ADAM9-Targeting ADC, IMGC936, which we are co-developing with MacroGenics. I thank Scott Koenig and the entire MacroGenics team for their partnership in delivering the IND. This is a