On July 30, 2021 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that recent progress in the business and reported financial results for the quarter ended June 30, 2021 (Press release, ImmunoGen, JUL 30, 2021, View Source [SID1234585468]).
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"With top-line data from our pivotal SORAYA trial on track for release in Q4, we have accelerated preparations for the BLA submission and commercial launch of mirvetuximab. In parallel, we continue to generate data that support mirvetuximab as the combination agent of choice for ovarian cancer patients," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "At ASCO (Free ASCO Whitepaper), we presented final data from our mirvetuximab plus Avastin doublet, showing compelling and durable anti-tumor activity, with a 64% ORR, 11.8 month mDOR, and 10.6 month mPFS in patients with high FRα recurrent ovarian cancer, regardless of platinum status. We believe these data are highly encouraging, particularly given outcomes with available therapies in this setting. As we continue to accrue our confirmatory MIRASOL trial, we are working to establish mirvetuximab as the new standard of care in patients with high FRα ovarian cancer, who comprise roughly 40% of the market. To this end, this quarter we are initiating PICCOLO, a single-arm study of mirvetuximab monotherapy in recurrent platinum-sensitive ovarian cancer to support label expansion."
Enyedy added, "Beyond mirvetuximab, our IMGN632, IMGC936, and IMGN151 programs are progressing as anticipated. Patient accrual continues in our IMGN632 trials in BPDCN and AML, with data from our AML cohort expected at ASH (Free ASH Whitepaper) next quarter. Our dose-escalation study of IMGC936 is enrolling in multiple solid tumor types and we are on track to file the IND for IMGN151 by year-end. With a focus on execution towards key inflection points, we look forward to transforming ImmunoGen into a fully integrated oncology company with the potential for two innovative ADCs on the market in 2022."
RECENT PROGRESS
Presented final data from the FORWARD II study evaluating mirvetuximab in combination with Avastin (bevacizumab) in patients with medium and high folate receptor alpha (FRα)-expressing recurrent ovarian cancer for whom a non-platinum based combination regimen is appropriate at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Annual Meeting.
Completed accrual in the pivotal SORAYA study and further enrolled patients in the confirmatory MIRASOL study for mirvetuximab.
Supported enrollment of investigator-sponsored trials of mirvetuximab plus carboplatin in a single-arm study in the neoadjuvant setting and in a randomized study in patients with recurrent platinum-sensitive ovarian cancer.
Advanced accrual in the pivotal 801 Phase 2 study of IMGN632 in frontline and relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Continued patient enrollment in the 802 Phase 1b/2 study of IMGN632 in combination with Vidaza (azacitidine) and Venclexta (venetoclax) in R/R acute myeloid leukemia (AML) patients and as a monotherapy in minimal residual disease positive (MRD+) AML.
Escalated dosing in the Phase 1 study of IMGC936 in multiple solid tumor types.
Progressed activities to support an investigational new drug (IND) application for IMGN151.
ANTICIPATED UPCOMING EVENTS
Release top-line data from the pivotal SORAYA study in the fourth quarter of 2021 and submit the biologics license application (BLA) in the first quarter of 2022 to support potential accelerated approval in 2022.
Generate top-line data for the confirmatory MIRASOL study in the third quarter of 2022.
Enroll the first patient in PICCOLO, a single-arm study of mirvetuximab monotherapy in high FRα recurrent platinum-sensitive ovarian cancer, in the third quarter of 2021, designed to support potential label expansion.
Present initial AML combination data for IMGN632 at the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2021.
Complete dose-escalation in the Phase 1 study evaluating IMGC936, with initial data anticipated in early 2022.
Submit the IND application for IMGN151 by the end of 2021.
FINANCIAL RESULTS
Revenues for the quarter ended June 30, 2021 were $16.9 million, compared with $15.0 million for the quarter ended June 30, 2020, which consisted primarily of non-cash royalty revenues.
Operating expenses for the second quarter of 2021 were $44.3 million, compared with $33.4 million for the same quarter in 2020. The increase was largely driven by research and development expenses, which were $34.6 million for the second quarter of 2021, compared with $22.9 million for the second quarter of 2020. This increase was due to greater clinical trial expenses driven by costs related to the MIRASOL, SORAYA, and IMGC936 studies, greater personnel and temporary staffing costs, and higher external manufacturing costs and third-party service fees in support of commercial readiness. General and administrative expenses for the second quarter of 2021 were $9.7 million, compared to $9.8 million for the second quarter of 2020.
Net loss for the second quarter of 2021 was $30.7 million, or $0.15 per basic and diluted share, compared to a net loss of $24.3 million, or $0.14 per basic and diluted share, for the second quarter of 2020. Weighted average shares outstanding increased to 199.9 million for the 2021 period from 174.4 million in the prior year.
ImmunoGen had $239.5 million in cash and cash equivalents as of June 30, 2021, compared with $293.9 million as of December 31, 2020, and had $1.1 million of convertible debt outstanding as of June 30, 2021, compared with $2.1 million as of December 31, 2020. Cash used in operations was $88.5 million for the first six months of 2021, compared with cash used in operations of $56.5 million for the same period in 2020. Capital expenditures were $(0.9) million for the first six months of 2021, compared with net proceeds from the sale of equipment of $1.4 million for the first six months of 2020.
FINANCIAL GUIDANCE
ImmunoGen’s financial guidance for 2021 remains unchanged:
revenues between $65 million and $75 million;
operating expenses between $200 million and $210 million; and
cash and cash equivalents at December 31, 2021 to be between $140 million and $150 million.
ImmunoGen expects that its current cash will fund operations into the second 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 1789134. The call may also be accessed through the Investors and Media section of the Company’s website, www.immunogen.com. Following the call, a replay will be available at the same location.