On November 2, 2018 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported operating results for the quarter ended September 30, 2018 (Press release, ImmunoGen, NOV 2, 2018, View Source [SID1234530623]).

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"With the completion of enrollment in FORWARD I, we have initiated the activities required to support a BLA filing and launch mirvetuximab soravtansine in ovarian cancer. Over the last three months, we have completed the product validation runs for drug substance, put in place operational metrics and resources to ensure timely assessment of the primary endpoint for the study, and moved ahead with pre-launch commercial planning," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "In parallel, we continued to execute across the remainder of the business, including presentation of initial data from the FORWARD II KEYTRUDA combination at ESMO (Free ESMO Whitepaper), accelerating accrual in the FORWARD II triplet cohort, and advancing our next ADC into preclinical development in collaboration with MacroGenics. Looking ahead to the fourth quarter and the coming year, with a strong cash runway, we are well-positioned to deliver on our strategic priorities and look forward to oral presentations for our novel IGN assets, IMGN779 and IMGN632, at ASH (Free ASH Whitepaper) in December and to announcing top-line results from FORWARD I during the first half of 2019."

PIPELINE PROGRESS AND PARTNER-RELATED UPDATES

Favorable tolerability and encouraging anti-tumor activity data from the FORWARD II expansion cohort of mirvetuximab soravtansine in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with platinum-resistant ovarian cancer were presented at the 2018 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in October. The goal of the combination is to prolong clinical benefit of the ADC in later-line patients through concomitant activation of the immune system.
The Food and Drug Administration (FDA) has granted orphan-drug designation to IMGN632 for the treatment of acute myeloid leukemia (AML).
ImmunoGen and MacroGenics advanced the IMGC936 (ADAM9-targeting ADC) program into IND-enabling activities. ADAM9-positive tumor types include non-small cell lung, triple-negative breast, gastric, and pancreatic cancers.
ImmunoGen presented preclinical data related to an epithelial cell adhesion molecule (EpCAM)-targeting Probody drug conjugate (PDC) at the European Antibody Congress in October. The EpCAM-targeting PDC integrates the PROBODY technology developed by CytomX, which enables the selection of targets previously thought to be incompatible with ADC development due to high normal tissue expression.
Roche announced in October that the Phase 3 KATHERINE study met its primary endpoint showing that KADCYLA (trastuzumab emtansine) as a single agent significantly reduced the risk of disease recurrence or death (invasive disease-free survival, iDFS) compared to HERCEPTIN (trastuzumab) as an adjuvant treatment in people with HER2-positive early breast cancer who have residual disease present following neoadjuvant treatment.
ANTICIPATED UPCOMING EVENTS

Oral presentation of data from IMGN779 Phase 1 dose finding study at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting;
Oral presentation of initial data from IMGN632 Phase 1 dose finding study at the 2018 ASH (Free ASH Whitepaper) Annual Meeting and preclinical poster sessions related to IMGN632;
Complete enrollment in the FORWARD II cohort assessing a triplet combination of mirvetuximab plus carboplatin and AVASTIN (bevacizumab) in patients with recurrent platinum-sensitive ovarian before the end of 2018, and report initial data in mid-2019;
Initiate a new expansion cohort in the FORWARD II study to evaluate mirvetuximab plus AVASTIN in patients with recurrent ovarian cancer in 1Q 2019; and
Report top-line results from Phase 3 FORWARD I trial of mirvetuximab soravtansine in 1H 2019.
FINANCIAL RESULTS
Revenues for the quarter ended September 30, 2018 were $10.9 million, compared with $8.5 million for the quarter ended September 30, 2017. License and milestone fees of $0.7 million for the third quarter of 2018 included recognition of a $0.5 million milestone pursuant to a license agreement with Fusion Pharmaceuticals. Revenues in the third quarter of 2018 included $8.4 million in non-cash royalty revenues, compared with $6.5 million for the same quarter in 2017. Revenues for the third quarter of 2018 also included $0.4 million of research and development (R&D) support fees and $1.4 million of clinical materials revenue, compared with $0.7 million and $1.2 million, respectively, for the same quarter in 2017.

Operating expenses for the third quarter of 2018 were $56.5 million, compared with $39.6 million for the same quarter in 2017. The increase was driven by R&D expenses, which were $47.2 million in the third quarter of 2018, compared with $31.7 million for the third quarter of 2017. This increase was primarily due to higher antibody and cytotoxic manufacturing costs in support of commercial validation runs for mirvetuximab soravtansine, along with higher clinical trial costs related to the FORWARD II combination assessments and, to a lesser extent, expenses resulting from stock-based compensation. General and administrative expenses in the third quarter of 2018 were $8.3 million, compared to $7.9 million in the same quarter of 2017. Operating expenses for the third quarter of 2018 also included a $0.9 million restructuring charge due to the workforce reduction related to the previously announced decommissioning of the Company’s Norwood facility.

ImmunoGen reported a net loss of $46.8 million, or $0.32 per basic and diluted share, for the third quarter of 2018, compared with a net loss of $56.7 million, or $0.61 per basic and diluted share, for the same quarter last year. Weighted average shares outstanding increased to 147.2 million from 93 million in those quarters.

ImmunoGen had $303.2 million in cash and cash equivalents as of September 30, 2018, compared with $267.1 million as of December 31, 2017, and had $2.1 million of convertible debt outstanding in each period. Cash used in operations was $125.1 million for the first nine months of 2018, compared with cash provided from operations of $37.1 million for the same period in 2017. The prior period benefited from a $30 million paid-up license fee received from Sanofi, a $75 million upfront payment received from Jazz Pharmaceuticals, and a $25 million upfront payment received from Debiopharm. Capital expenditures were $4.2 million and $0.8 million for the nine months ended September 30, 2018 and 2017, respectively.

FINANCIAL GUIDANCE
ImmunoGen has updated its cash and revenue guidance for 2018. ImmunoGen now expects:

cash and cash equivalents at December 31, 2018 to be between $250 million and $255 million; and
revenues between $50 million and $55 million.
Guidance for operating expenses remains unchanged:

operating expenses between $215 and $220 million.
ImmunoGen expects that its current cash combined with the expected cash revenues from partners and collaborators will enable the Company to fund its operations at least a year beyond the top-line results from the Phase 3 FORWARD I trial, which are expected in the first half of 2019.

CONFERENCE CALL INFORMATION
ImmunoGen will hold a conference call today at 8:00 am ET to discuss these results. To access the live call by phone, dial 323-794-2423; the conference ID is 8582527. 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 November 16, 2018.