ImmunoGen, Inc. (NASDAQ:IMGN) Q4 2019 Earnings Conference Call - Final Transcript

Feb 14, 2020 • 08:00 am ET

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ImmunoGen, Inc. (NASDAQ:IMGN) Q4 2019 Earnings Conference Call - Final Transcript

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Presentation
Operator
Operator

Good morning and welcome to ImmunoGens Fourth Quarter and Full Year 2019 Financial and Operating Results Conference Call. Today's conference is being recorded. At this time, I'd like to turn the call over to Courtney O'Konek, Senior Director of Corporate Communications and Investor Relations. Please go ahead.

Executive
Courtney O'Konek

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 fourth quarter and full Year 2019 financial results. This press release and 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 and Anna Berkenblit, our Chief Medical Officer. Theresa Wingrove, our Senior Vice President of Regulatory Affairs and Quality and Dave Foster, our Chief Accounting Officer will also join us for Q&A.

During today's call, we'll review key accomplishments for the business over the last 12 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.

Executive
Mark Enyedy

Thanks, Courtney. Good morning everyone and thank you for joining us today. In our comments this morning, Anna and I will recap our progress over the last 12 months and then highlight the milestones we anticipate for a productive year ahead. 2019 was a challenging year for us. As we reported in March, the Phase 3 study for our lead program Mirvetuximab did not meet the primary endpoint. Since then we have restructured the business to reduce our cost, prioritized our portfolio to focus on our most promising programs and worked closely with FDA to define an accelerated path to approval for Mirvetuximab in ovarian cancer. With the benefit of these steps we've emerged with strong prospects for ImmunoGen as we move into 2020. In particular, looking at the business today, the data we've generated from the Phase 3 study of Mirvetuximab give us a clear view of which patients benefit most from Mirvetuximab and how best to identify those patients. This in turn gives us confidence that our next studies with Mirvetuximab will produce positive outcomes.

To this end, we have aligned with FDA that a single-arm study in women with folate receptor alpha high platinum resistant ovarian cancer who have been previously treated with Avastin could support accelerated approval. We call this study SORAYA and expect to enroll the first patient this quarter with top-line data anticipated in mid 2021 followed by a BLA submission in the second half of 2021 and a potential approval in 2022. Beyond the first approval, we have ongoing studies to expand the potential indications for Mirvetuximab with additional data this year.

Our portfolio also includes three additional programs targeting a range of tumor types in both hematological malignancies and solid tumors, each