On November 1, 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 September 30, 2019 (Press release, ImmunoGen, NOV 1, 2019, View Source [SID1234550171]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"The FORWARD I analyses presented at ESMO (Free ESMO Whitepaper) have provided us with valuable insights into the patients who benefit most from mirvetuximab," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "We have since met with FDA to review these data and the design of MIRASOL, the Phase 3 study of mirvetuximab for platinum-resistant ovarian cancer patients whose tumors express high levels of folate receptor alpha. We anticipate enrolling our first patient before year-end and, on the strength of the data we have generated in the program, believe we have increased the likelihood of a positive outcome with this next study."
Enyedy added, "IMGN632 continues to make encouraging progress in the clinic, with the initiation of combination studies in relapsed/refractory AML patients and monotherapy expansion into relapsed ALL and MRD+ AML patients following frontline induction therapy. We exit the year with significant momentum across our portfolio with an oral presentation for IMGN632 at ASH (Free ASH Whitepaper), ongoing studies for mirvetuximab combination regimens, advances in our early-stage pipeline, and a strong financial position to execute against our strategic priorities."
RECENT PROGRESS
Presented full data and additional exploratory analyses from the Phase 3 FORWARD I study evaluating mirvetuximab compared to chemotherapy in women with folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.
Presented initial safety and overall response data from the Phase 1b FORWARD II triplet cohort evaluating mirvetuximab in combination with carboplatin and Avastin (bevacizumab) in patients with recurrent, platinum-sensitive ovarian cancer at ESMO (Free ESMO Whitepaper).
Met with the United States Food and Drug Administration (FDA) to review the design of MIRASOL, the Phase 3 study evaluating mirvetuximab as monotherapy for women with FRα-high, platinum-resistant ovarian cancer.
Completed enrollment in the FORWARD II mirvetuximab plus bevacizumab combination cohort in "platinum agnostic" ovarian cancer patients for whom a non-platinum-based regimen would be an appropriate next therapy.
For IMGN632 monotherapy, continued enrollment in the Phase 1 expansion cohorts in patients with acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN), opened an expansion cohort now enrolling patients with relapsed acute lymphocytic leukemia (ALL), and initiated a study in minimal residual disease positive (MRD+) AML patients following frontline induction therapy.
For IMGN632 combination therapy, initiated studies with Vidaza (azacitidine) and Venclexta (venetoclax) in relapsed/refractory unfit AML patients.
Advanced investigational new drug (IND)-enabling activities for IMGC936, a novel ADAM9-targeting ADC in co-development with MacroGenics.
ANTICIPATED UPCOMING EVENTS
Initiate MIRASOL by year-end.
Present preclinical combination data (poster presentation) and updated clinical monotherapy data (oral presentation) for IMGN632 with additional patients enrolled in AML and BPDCN expansion cohorts at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December.
Continue enrollment in IMGN632 combination and single-agent BPDCN, relapsed AML, MRD+ AML, and relapsed ALL expansion cohorts.
IND filing for IMGC936 in the first half of 2020.
Present initial data from FORWARD II platinum agnostic and updated triplet combination studies in mid-2020.
Transition next generation anti-FRα ADC, IMGN151, to pre-clinical development in mid-2020.
FINANCIAL RESULTS
Revenues for the quarter ended September 30, 2019 were $13.3 million, compared with $10.9 million for the quarter ended September 30, 2018. Revenues in the third quarter of 2019 included $13.2 million in non-cash royalty revenues, compared with $8.4 million for the third quarter of 2018. Revenues for the prior year period also included $0.7 million of license and milestone fees, inclusive of a $0.5 million milestone pursuant to a license agreement with Fusion Pharmaceuticals, $0.4 million of research and development (R&D) support fees, and $1.4 million of clinical materials revenue, compared with $0.1 million of similar fees earned in the current period.
Operating expenses for the third quarter of 2019 were $31.2 million, compared with $56.5 million for the same quarter in 2018. The decrease was driven by R&D expenses, which were $21.0 million in the third quarter of 2019 compared with $47.2 million for the third quarter of 2018. This decrease was primarily due to: lower expenses resulting from the restructuring of the business at the end of the second quarter of 2019, including decreases in personnel and third-party research expenses and lower facility-related allocations; a decrease in clinical trial expenses in the current period driven by greater activity in the FORWARD I Phase 3 clinical trial during the prior year period; and lower external manufacturing costs driven by activity to support commercial validation of mirvetuximab in the prior year period. General and administrative expenses in the third quarter of 2019 were $9.2 million, compared to $8.3 million in the third quarter of 2018, primarily due to a higher allocation of facility-related expenses for excess laboratory and office space resulting from the recent restructuring. Operating expenses for the third quarter of 2019 also included a $1.0 million charge related primarily to retention costs resulting from the restructuring, compared to a $0.9 million charge recorded in the third quarter of 2018 related to the decommissioning of the Company’s Norwood facility.
ImmunoGen reported a net loss of $21.8 million, or $0.15 per basic and diluted share, for the third quarter of 2019, compared with a net loss of $46.8 million, or $0.32 per basic and diluted share, for the same quarter last year. Weighted average shares outstanding increased to 148.5 million from 147.2 million in those quarters.
ImmunoGen had $204.5 million in cash and cash equivalents as of September 30, 2019, compared with $262.3 million as of December 31, 2018, and had $2.1 million of convertible debt outstanding in each period. Cash used in operations was $55.8 million for the first nine months of 2019, compared with cash used in operations of $125.1 million for the same period in 2018. The current period benefited from $65.2 million of net proceeds generated from the sale of the Company’s residual rights to Kadcyla (ado-trastuzumab emtasine) royalties in January 2019. Capital expenditures were $2.8 million and $4.2 million for the first nine months of 2019 and 2018, respectively.
FINANCIAL GUIDANCE
ImmunoGen has updated its financial guidance for 2019 as follows:
revenues between $65 million and $70 million;
operating expenses between $170 million and $175 million; and
cash and cash equivalents at December 31, 2019, between $170 million and $175 million.
Revenue guidance has been updated to reflect recognition of deferred revenue under our Jazz Pharmaceuticals collaboration related to IMGN779, which was discontinued as part of ImmunoGen’s portfolio prioritization exercise in June of this year. ImmunoGen expects that its current cash, together with expense reductions resulting from the operational changes previously announced and anticipated cash receipts from partners, will fund operations through the release of top-line results from MIRASOL, which are expected in the first half of 2022.
CONFERENCE CALL INFORMATION
ImmunoGen will hold a conference call today at 8:00 a.m. ET to discuss these results. To access the live call by phone, dial (877) 621-5803; the conference ID is 8865657. The call may also be accessed through the Investors and Media section of immunogen.com. Following the call, a replay will be available at the same location.