February 22, 2017
By Mark Terry, BioSpace.com Breaking News Staff
Waltham, Mass.-based ImmunoGen held its quarterly earnings report on Friday, February 17. ImmunoGen is shifting from a June-to-June fiscal year to a December-to-December. As a result, this report marked the end of the two-quarter transition period.
The company reported $13.8 million in revenue in the quarter ending December 2016, down 23 percent from the same quarter in 2015. Income from operations in the quarter ending December 2016 was a loss of $28.6 million, compared to a loss of $28.2 million in the same quarter in 2015.
“In 2016, we strengthened ImmunoGen operationally and financially with a focused strategy and disciplined execution,” said Mark Enyedy, ImmunoGen’s president and chief executive officer, in a statement. “Building upon this momentum, we entered 2017 well positioned to deliver on multiple clinical milestones. In January, we advanced our lead program to Phase III, dosing the first patient in the FORWARD I study of mirvetuximab soravtansine in ovarian cancaer. At the Society of Gynecologic Oncology annual meeting next month, we will present data from the mirvetuximab biopsy cohort, followed by initial data in the second quarter from the mirvetuximab combination regimens being evaluated in our FORWARD II study. We are also excited about the potential of our DNA-alkylating ADCs and expect to report the first data from the Phase I study of IMGN779 for acute myeloid leukemia in mid-2017 and to file an IND for IMGN632 in the third quarter.”
At the conference call, the company’s chief medical officer, Anna Berkenblit, gave a little more granularity on the FORWARD II trial that is testing mirvetuximab soravtansine in combination with Avastin, carboplatin, Doxil, or Keytruda. “At this point,” she said, “we have been able to give the highest dose of mirvetuximab soravtansine, which is 6 milligrams per kilogram—identical to the monotherapy dose—in combination with each of the highest dose for each of the combination agents—and those are the monotherapy doses that are typically used in ovarian cancer.”
The company indicates it hopes to have $35 million to $40 million in cash by the end of this year, although that doesn’t include any potential deals. Brian Orelli, writing for The Motley Fool, notes, “Hopefully the nest egg will be larger—because that’s not enough to get the company through a 2020 readout of FORWARD I.”
ImmunoGen’s update indicates it’s projecting an approval of mirvetuximab soravtansine in ovarian cancer by 2020. Phase Ib/II trial data from FORWARD II is expected in this year’s second quarter. The company also expects to release pooled data from over 100 ovarian cancer patients receiving the drug in several Phase I trials. Orelli writes, “Positive data from those trials should give investors confidence that the FORWARD I trial will turn out positive. Further back in the pipeline, IMGN779 is set to report data from a Phase I clinical trial in patients with acute myeloid leukemia in mid-2017. And ImmunoGen plans to get FDA approval to start clinical trials on a new drug candidate, IMGN632, in the third quarter.”
At the conference call, the company’s chief financial officer, Dave Johnston, said, “In looking at our portfolio, we decided that, while we are enthusiastic about our DLBCL compounds, we have to focus. And, in deciding to focus on mirvetuximab and the AML products, we chose to monetize the DLBCL assets and conversations are under way right now.”
