On May 3, 2019 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported financial results for the quarter ended March 31, 2019 (Press release, ImmunoGen, MAY 3, 2019, View Source [SID1234535656]).
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"Following the readout of the top-line results from FORWARD I, we have undertaken a comprehensive analysis of the data and see a consistent efficacy signal across a range of parameters in the pre-specified subset of ovarian cancer patients with high folate receptor alpha (FRα) expression. Specifically, in comparison to chemotherapy, we have observed higher response rates, more durable responses, and longer progression-free and overall survival in patients with high FRα expression treated with mirvetuximab," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "With the benefit of this analysis and input from our clinical and regulatory advisors, we will be meeting with the FDA this quarter to discuss a potential path to registration for mirvetuximab as a monotherapy."
Enyedy continued, "In parallel, our FORWARD II combination trial continues to enroll patients and we look forward to presenting mature data for mirvetuximab in combination with Avastin in platinum-resistant ovarian cancer patients at ASCO (Free ASCO Whitepaper). In addition, we ended the quarter with $270 million on the balance sheet and are conducting an operational review to enable us to extend our cash runway and execute against our goal of delivering more good days to people with cancer."
RECENT PROGRESS
Mirvetuximab Soravtansine
Top-line results announced from the Phase 3 FORWARD I study of mirvetuximab soravtansine in FRα-positive, platinum-resistant ovarian cancer; data from the pre-specified subset of patients with high FRα expression suggest a favorable benefit-risk profile in this population.
Enrollment initiated for FORWARD II Avastin (bevacizumab) cohort in ovarian cancer patients for whom a non-platinum-based regimen would be an appropriate next therapy; this "platinum agnostic" population will include patients progressing after PARP inhibitor maintenance therapy, who represent an increasing share of the market.
IGN Programs, Early-Stage Pipeline, and Research
Enrollment continues in expansion cohorts of a Phase 1 study of IMGN632 in patients with relapsed or refractory adult acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN); study expanded to Europe.
Enrollment nearing completion for Phase 1 study of IMGN779 in AML patients.
IND-enabling activities on track for IMGC936, a novel ADAM9-targeting ADC being developed in collaboration with MacroGenics.
Eleven posters presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in March demonstrating continued innovation from the Company’s research platform.
Operational Updates
Sale of residual rights to receive royalty payments on commercial sales of Kadcyla (ado-trastuzumab emtansine) to the Ontario Municipal Employees Retirement System (OMERS), the defined benefit pension plan for municipal employees in the Province of Ontario, Canada, completed for $65 million.
Operational review of the business underway with the objective of extending the Company’s cash runway.
ANTICIPATED UPCOMING EVENTS
Meet with the U.S. Food and Drug Administration (FDA) in Q2 to discuss a potential path to registration for mirvetuximab soravtansine as a monotherapy for the treatment of platinum-resistant ovarian cancer patients with high FRα expression; the Company also plans to engage with the European Medicines Agency (EMA) around conditional marketing authorization;
Present mature data from the FORWARD II expansion cohort evaluating mirvetuximab in combination with Avastin in patients with platinum-resistant ovarian cancer at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting; additional data from an investigator-sponsored study evaluating mirvetuximab in combination with gemcitabine will also be presented;
Present full FORWARD I data and initial FORWARD II triplet data at a medical meeting later this year;
Present updated IMGN632 data with additional AML and BPDCN patients, and establish the recommended Phase 2 dose and schedule; initiate IMGN632 combination studies;
Establish IMGN779 recommended Phase 2 dose and schedule; and
Submit an IND for IMGC936 before the end of 2019.
FINANCIAL RESULTS
Revenues for the quarter ended March 31, 2019 were $8.6 million, compared with $19.8 million for the quarter ended March 31, 2018. Revenues in the first quarter of 2019 included $8.5 million in non-cash royalty revenues, compared with $7.2 million for the first quarter of 2018. Revenues for the prior year period also included $11.5 million of recognized upfront license and milestone fees previously received from partners, $0.4 million of research and development (R&D) support fees, and $0.7 million of clinical materials revenue, compared with $0.1 million of similar fees earned in the current period.
Operating expenses for the first quarter of 2019 were $50.2 million, compared with $56.6 million for the same quarter in 2018. The decrease was driven by R&D expenses, which were $38.9 million in the first quarter of 2019, compared with $44.8 million for the first quarter of 2018. This decrease was primarily due to lower clinical trial costs in the current period, driven by patient enrollment in the FORWARD I Phase 3 clinical trial during the prior year period. General and administrative expenses in the first quarter of 2019 were $10.8 million, compared to $10.0 million in the first quarter of 2018, primarily due to increased personnel costs driven by greater stock-based compensation and severance expense, partially offset by decreased third-party service fees. Operating expenses for the first quarter of 2019 also included a $0.6 million restructuring charge related to a loss recorded on leased office space, compared to a $1.7 million charge recorded in the first quarter of 2018 related to the decommissioning of the Company’s Norwood facility.
ImmunoGen reported a net loss of $43.8 million, or $0.30 per basic and diluted share, for the first quarter of 2019, compared with a net loss of $38.6 million, or $0.30 per basic and diluted share, for the same quarter last year. Weighted average shares outstanding increased to 147.8 million from 130.6 million in those quarters.
ImmunoGen had $270.4 million in cash and cash equivalents as of March 31, 2019, compared with $262.3 million as of December 31, 2018, and had $2.1 million of convertible debt outstanding in each period. Cash provided by operations was $10.2 million for the first quarter of 2019, compared with cash used in operations of $(50.0) million for the first quarter of 2018. The current period benefited from $65.2 million of net proceeds generated from the sale of the Company’s residual rights to Kadcyla royalties in January 2019. Capital expenditures were $2.1 million and $1.0 million for the first quarter of 2019 and 2018, respectively.
FINANCIAL GUIDANCE
ImmunoGen will provide an update on the Company’s 2019 financial guidance following the completion of the operational review.
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 323-994-2093; the conference ID is 8980567. The call may also be accessed through the Investors and Media 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 May 17, 2019.