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Immunogen Inc. (IMGN)
Q1 2019 Earnings Conference Call
May 3, 2019 08:00 ET
Sarah Kiely - Director, Investor Relations and Corporate Communications
Mark Enyedy - President and Chief Executive Officer
Anna Berkenblit - Chief Medical Officer
Rich Gregory - Chief Scientific Officer
Dave Foster - Chief Accounting Officer
Conference Call Participants
John Newman - Canaccord
Andy Hsieh - William Blair
Kennen MacKay - RBC Capital Markets
Michael Schmidt - Guggenheim
Biren Amin - Jefferies
David Ruch - SVB Leerink
Boris Peaker - Cowen
Jessica Fye - JPMorgan
Debjit Chattopadhyay - H.C. Wainwright
Previous Statements by IMGN
» ImmunoGen, Inc. (IMGN) CEO Mark Enyedy on Q4 2018 Results - Earnings Call Transcript
» ImmunoGen, Inc. (IMGN) CEO Mark Enyedy on Q3 2018 Results - Earnings Call Transcript
» ImmunoGen, Inc. (IMGN) CEO Mark Enyedy on Q2 2018 Results - Earnings Call Transcript
Good morning and thank you for joining today’s call. Earlier today, we issued a press release that includes the summary of our recent progress and first quarter 2019 financial results. This press release and a recording of the call can be found under the Investors & Media section of our website at immunogen.com.
On the call today are Mark Enyedy, our President and CEO; and Anna Berkenblit, our Chief Medical Officer. Rich Gregory, our Chief Scientific Officer; and Dave Foster, our Chief Accounting Officer, will join the team for the Q&A session.
During today’s call, we will discuss recent progress, review our first quarter financial results and highlight 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.
With that, I will turn the call over to Mark.
Thanks, Sarah. Good morning, everyone and thank you for joining us today. In early March, we announced top line results from the Phase 3 FORWARD I study of mirvetuximab in platinum-resistant ovarian cancer patients. While we were disappointed that the trial did not meet its primary endpoint, we were encouraged to see a consistent efficacy signal in the pre-specified subset of patients with high folate receptor alpha expression. Specifically, in comparison to chemotherapy, we observed more than twice the response rate and more durable responses with mirvetuximab in this patient population. In addition, progression-free and overall survival, were longer in the mirvetuximab-treated patients. We believe this consistent efficacy signal, coupled with differentiated safety and tolerability demonstrate a favorable benefit risk profile for mirvetuximab. With the benefit of these additional analyses of the data from FORWARD I and input from our clinical and regulatory advisors, we will be meeting with the FDA this quarter to discuss the potential path to registration for mirvetuximab monotherapy in the FR alpha high population. We look forward to updating you on the outcome of those discussions.
Moving to our FORWARD II trial, we have generated promising data with mirvetuximab combination regimens with the goal of expanding our market opportunity for mirvetuximab in the earlier lines of therapy. Anna will update you on our progress and upcoming data from this study. In addition, we are evaluating combination approaches as an independent avenue to support a label for mirvetuximab. Looking beyond mirvetuximab, we are advancing our novel IGN programs, IMGN632 and IMGN779, in hematological malignancies. We continue to enroll patients in expansion cohorts of the Phase 1 study of IMGN632 in patients with relapsed or refractory AML and BPDCN, and we are nearing completion of the crew for our Phase 1 study of IMGN779 in AML patients, with data expected for both studies later this year. Separately, we are on track with IND-enabling activities for IMGC936, our novel ADAM9-targeting ADC that’s being developed in collaboration with MacroGenics, with a submission plan for 936 before the end of this year.
Turning to our financial results, which were detailed in the press release we issued this morning. ImmunoGen is in a strong financial position with approximately $270 million on the balance sheet, providing flexibility for continued investment in our portfolio. The previously announced operational review of the business to extend our cash runway is ongoing, and we expect to announce the results of this effort following our engagement with the FDA.
Regarding our first quarter financials, we generated $8.6 million in revenue, which included $8.5 million in noncash royalty revenues related to Kadcyla sales. Our operating expenses for the first quarter were approximately $50 million compared with $57 million for the same quarter in 2018. The decrease was primarily related to lower clinical trial cost in the current period compared to the prior year when these expenses were driven by accelerating patient accrual in FORWARD I. As previously noted, we ended the quarter with approximately $270 million in cash and cash equivalents on the balance sheet. We will provide an update on our 2019 financial guidance following the completion of our operational review.
With that, I’ll turn the call over to Anna to review our pipeline progress in more detail. Anna?
Thanks Mark. As mentioned, we have recently announced top line results from the Phase 3 FORWARD I study of mirvetuximab soravtansine. While we are disappointed that this study did not meet its primary endpoint, we remain encouraged by the consistent signals of efficacy in the prespecified high folate receptor alpha subset. Additional analysis we subsequently conducted reinforced the consistency of the efficacy signals we initially observed in the top line results.
For the safety perspective, mirvetuximab is well tolerated, with fewer Grade 3 or greater adverse events, dose modifications and treatment-related discontinuation than chemotherapy. For those patients with high folate receptor alpha expression, we believe these data demonstrate a favorable benefit risk profile in platinum-resistant ovarian cancer, a population that still has a high unmet need, highlighted by recent disappointment from Phase 3 trials of a checkpoint inhibitor and a novel chemotherapy.