ImmunoGen: Announces Completion of Operational Review

Company Will Prioritize Continued Development of Mirvetuximab Soravtansine and a Select Portfolio of Earlier-Stage Candidates

Cash Runway Extended Through Readout of Mirvetuximab Soravtansine Pivotal Trial in Ovarian Cancer

Conference Call to be Held at 8 a.m. ET Today

ImmunoGen, Inc., (Nasdaq:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced the completion of an in-depth operational review designed to extend the Company’s cash runway and deliver on its commitment to develop next-generation ADCs to bring more good days to patients and generate increased value for shareholders. Based on the outcomes of this review, the Company will prioritize continued development of mirvetuximab and a select portfolio of three earlier-stage product candidates targeting solid tumors and hematological malignancies. The Company will end the current quarter with approximately $240 million on its balance sheet and expects this cash, together with expense reductions resulting from the operational changes announced today and anticipated cash receipts from partners, will fund operations through the release of top-line results from the upcoming mirvetuximab Phase 3 study in platinum-resistant ovarian cancer, which are expected in the first half of 2022.

The operational review commenced following the announcement that FORWARD I, ImmunoGen’s Phase 3 clinical trial evaluating mirvetuximab compared to chemotherapy in women with folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer, did not meet the primary endpoint. Data from FORWARD I did, however, demonstrate a consistent efficacy signal across a range of parameters in the pre-specified subset of patients with high FRα expression. Following consultation with the U.S. Food and Drug Administration (FDA), the Company will pursue a new Phase 3 study in this patient population.

In light of these developments and with the goal of extending the Company’s existing cash runway, ImmunoGen has established three strategic priorities for the business: execute a registration study for mirvetuximab in platinum-resistant ovarian cancer; advance a select portfolio of earlier-stage product candidates; and further strengthen its balance sheet through partnering. Consistent with these priorities, ImmunoGen will focus on the following core activities:

• Initiate the registration study for mirvetuximab as a monotherapy for women with FRα-high, platinum-resistant ovarian cancer by the end of this year;
• Complete enrollment and continue follow up in the ongoing FORWARD II mirvetuximab combination cohorts;
• Continue IMGN632 development in patients with relapsed acute myeloid leukemia (AML), blastic plasmacytoid dendritic cell neoplasm (BPDCN), and other CD123-positive hematologic malignancies in collaboration with Jazz Pharmaceuticals;
• Advance two additional assets that demonstrate ImmunoGen’s continued innovation in ADCs: IMGC936, which is in co-development with MacroGenics with an IND expected by the end of 2019; and the Company’s next generation anti-FRα ADC, which is expected to enter development in mid-2020; and
• Monetize its remaining portfolio and platform technologies through out-licensing transactions or asset sales.

Correspondingly, the Company will reduce ongoing expenses through the following portfolio prioritization and restructuring initiatives:

• Discontinue the development of IMGN779 in adults with relapsed/refractory CD33-positive AML;
• Suspend all other research activities;
• Reduce its workforce by approximately 220 employees, with a majority of these employees separating from the business by mid-July 2019; and
• Seek to sub-lease excess office and lab space.

Following a transition period, the savings generated by the restructuring are expected to reduce ImmunoGen’s quarterly expenses by more than 50%. As a result of the workforce reduction, the Company expects to record a one-time charge totaling approximately $16.4 million related to termination benefits and other related expenses. This charge is expected to be recorded in the quarter ending June 30, 2019, and the related cash payments will be substantially paid out by June 30, 2020. In addition, an anticipated charge of $3.7 million is expected to be incurred for retention benefits in the same time period. Updated 2019 financial guidance will be provided when ImmunoGen announces it second quarter operating results on August 2,2019.

CONFERENCE CALL INFORMATION

ImmunoGen will hold a conference call today at 8 a.m. ET to discuss these results. To access the live call by phone, dial 1-786-789-4797; the conference ID is 6921368. The call may also be accessed through the Investors section of the Company’s website, www.immunogen.com. Following the live webcast, a replay of the call will be available at the same location through July 9, 2019.

https://www.marketscreener.com/IMMUNOGEN-INC-9667/news/ImmunoGen-Announces-Completion-of-Operational-Review-28821868/