On May 6, 2022 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, 2022 (Press release, ImmunoGen, MAY 6, 2022, View Source [SID1234613758]).
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"Following the presentation of the results from our positive pivotal SORAYA trial at SGO, we were pleased to submit the BLA to support the accelerated approval of mirvetuximab monotherapy in FRα-high platinum-resistant ovarian cancer. We requested Priority Review for the BLA and look forward to acceptance towards the end of May and a PDUFA date on the application later this year," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "In preparation for potential commercialization, we have significantly ramped our launch readiness activities, with a focus on increasing mirvetuximab and FRα awareness among prescribers."
Enyedy continued, "The broader mirvetuximab program is also advancing nicely, with accrual accelerating in MIRASOL following the release of the SORAYA results in late November, enrollment continuing in PICCOLO, and initiation of our GLORIOSA and Trial 0420 combination studies anticipated by mid-year. Based upon a reforecast generated in conjunction with the recent pre-specified interim futility analysis for MIRASOL, we now expect to reach the requisite number of PFS events in the fourth quarter and will report top-line data from MIRASOL in early 2023. Turning to our second pivotal program, pivekimab, with the recommended phase 2 dose for the triplet in combination with azacitidine and venetoclax determined, we have moved forward with expansion cohorts in both frontline and relapsed AML patients and are on track to report preliminary efficacy data from our pivotal CADENZA study in BPDCN before year-end. Regarding our earlier-stage programs, dose-escalation continues in the Phase 1 trial of IMGC936 in multiple solid tumors and the activities to generate the CMC information needed for our IND for IMGN151 are on track. With a strong start and intense focus on execution, we are well positioned to deliver on our near-term objectives and transform ImmunoGen into a fully-integrated oncology company this year."
RECENT PROGRESS
Submitted the biologics license application (BLA) under the accelerated approval pathway to the US Food and Drug Administration (FDA) for mirvetuximab soravtansine (mirvetuximab) monotherapy in patients with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with 1 to 3 prior systemic treatments.
Presented results from the pivotal SORAYA trial of mirvetuximab, demonstrating impressive anti-tumor activity and durability of response, together with a differentiated safety profile, at the Society of Gynecologic Oncology (SGO) 2022 Annual Meeting.
Continued enrollment in the confirmatory MIRASOL study and recently completed a pre-specified interim futility analysis with a recommendation from the Independent Data Monitoring Committee for MIRASOL to proceed without modification.
Advanced accrual in PICCOLO, a single-arm study of mirvetuximab monotherapy in FRα-high recurrent platinum-sensitive ovarian cancer.
Supported investigator-sponsored trials of mirvetuximab plus carboplatin in a single-arm study in the neoadjuvant setting and a randomized study in patients with recurrent platinum-sensitive ovarian cancer.
Progressed the pivotal Phase 2 CADENZA study of pivekimab sunirine (pivekimab, formerly IMGN632) in frontline and relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Initiated expansion cohorts in the Phase 1b/2 study evaluating pivekimab, Vidaza (azacitidine), and Venclexta (venetoclax) in both relapsed and frontline unfit acute myeloid leukemia (AML) patients.
Advanced dose escalation and opened additional sites in the Phase 1 study of IMGC936 in multiple solid tumor types.
Progressed the generation of supplemental chemistry, manufacturing, and controls (CMC) information to the FDA to support the investigational new drug (IND) application for IMGN151.
Announced a global licensing agreement granting Eli Lilly and Company (Lilly) exclusive rights to research, develop, and commercialize ADCs directed to targets selected by Lilly based on ImmunoGen’s novel camptothecin technology in exchange for up to $1.7 billion in potential exercise fees and milestone payments.
ANTICIPATED UPCOMING EVENTS
Potential for BLA acceptance by FDA under the accelerated approval pathway for mirvetuximab as a monotherapy in patients with FRα-high platinum-resistant ovarian cancer who have been previously treated with 1 to 3 prior systemic treatments.
Present additional efficacy and safety analyses from the mirvetuximab program at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June.
Generate top-line data for MIRASOL in early 2023.
Initiate two combination studies for mirvetuximab in platinum-sensitive ovarian cancer by mid-2022: Trial 0420, a single-arm Phase 2 trial of mirvetuximab in combination with carboplatin followed by mirvetuximab continuation in FRα-low, medium, and high patients; and GLORIOSA, a randomized Phase 3 trial of mirvetuximab in combination with Avastin (bevacizumab) maintenance in FRα-high patients.
Report preliminary efficacy data from the pivotal CADENZA study of pivekimab in BPDCN before year-end.
Present initial data from frontline and relapsed AML expansion cohorts combining pivekimab, azacitidine, and venetoclax at the 2022 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December.
Complete dose-escalation in the Phase 1 study evaluating IMGC936, with initial data anticipated before year-end.
Begin enrollment in the Phase 1 study of IMGN151 following the submission of supplemental CMC information to the FDA.
FINANCIAL RESULTS
Total revenues were $38.1 million for the quarter ended March 31, 2022 compared to $15.7 million for the quarter ended March 31, 2021. The increase was driven by the recognition of $21.6 million of fees previously received and deferred pursuant to the Company’s collaboration agreement with Huadong Medicine and the recognition of $9.2 million of a $13.0 million upfront payment received pursuant to the Company’s license agreement with Lilly in the first quarter of 2022. Partially offsetting these increases, non-cash royalty revenue decreased $9.1 million due to the completion of the first tranche of payments under the 2015 KADCYLA royalty agreement in the second quarter of 2021.
Operating expenses for the quarter ended March 31, 2022 were $60.9 million, compared with $44.6 million for the same quarter in 2021. Research and development expenses rose to $44.3 million for the quarter ended March 31, 2022 compared to $34.4 million for the quarter ended March 31, 2021, driven by increases in personnel and temporary staffing costs, regulatory filing fees, third-party service fees, and external manufacturing costs in support of commercial readiness. Selling, general and administrative expenses increased to $16.6 million for the quarter ended March 31, 2022 compared to $10.2 million for the quarter ended March 31, 2021, due primarily to building commercial capabilities, including the hiring of personnel, in anticipation of a potential US launch of mirvetuximab in the second half of 2022.
Net loss for the first quarter of 2022 was $24.1 million, or $0.10 per basic and diluted share, compared to a net loss of $34.1 million, or $0.17 per basic and diluted share, for the first quarter of 2021. Weighted average shares outstanding increased to 253.3 million for the 2022 period from 198.8 million in the prior year.
ImmunoGen had $437.7 million in cash and cash equivalents as of March 31, 2022, compared with $478.8 million as of December 31, 2021. Cash used in operations was $41.4 million for the first three months of 2022, compared with cash used in operations of $44.6 million for the same period in 2021, with the current period benefitting from a $13.0 million upfront license payment received from Lilly. Capital expenditures were $0.3 million and $0.9 million for the first three months of 2022 and 2021, respectively.
FINANCIAL GUIDANCE
ImmunoGen’s financial guidance for 2022 remains unchanged; the Company continues to expect:
revenues between $75 million and $85 million;
operating expenses between $285 million and $295 million; and
cash and cash equivalents at December 31, 2022 to be between $245 million and $255 million.
Given the range in timing for potential approval, revenue guidance does not yet include potential product sales from mirvetuximab.
ImmunoGen expects that its current cash, combined with anticipated product and collaboration revenues, will fund operations into 2024.
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 5444669. 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.