On March 1, 2023 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported its recent progress in the business and reported financial results for the quarter and year ended December 31, 2022 (Press release, ImmunoGen, MAR 1, 2023, View Source [SID1234627945]).
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"We significantly advanced the business on multiple fronts over the last 12 months, most notably with the accelerated approval and launch of ELAHERE for patients with platinum-resistant ovarian cancer," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "We have seen broad and deep adoption of ELAHERE to date, with FRα testing, managed care coverage, and provider access all exceeding our expectations. Building upon this progress and in line with our goal of obtaining full approval for ELAHERE in the US and expanding into Europe, we will imminently reach the requisite number of PFS events in the confirmatory MIRASOL trial and expect to announce top-line data in the second quarter. In parallel, we are pursuing our broader development program in support of moving ELAHERE into platinum-sensitive disease and positioning ELAHERE as the combination agent of choice in ovarian cancer."
Enyedy continued, "Turning to our second pivotal program, pivekimab sunirine, we presented promising findings from our triplet expansion cohorts in AML in an oral presentation at ASH (Free ASH Whitepaper) in December, and continued enrollment in the pivotal CADENZA trial in frontline BPDCN with top-line data in de novo patients anticipated in 2024. We are also progressing our earlier-stage portfolio with the completion of dose escalation in the Phase 1 study of IMGC936, while also having dosed the first patient in our Phase 1 trial for IMGN151 in January. Combining our commitment to advance our pipeline of novel ADCs along with driving the commercial uptake of ELAHERE in the US, we are well positioned for another exciting and productive year."
RECENT PROGRESS
ELAHERE (mirvetuximab soravtansine-gynx)
Received US Food and Drug Administration (FDA) accelerated approval of ELAHERE for folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer (PROC) on November 14, 2022.
Generated $2.6 million in net sales for the fourth quarter of 2022.
ELAHERE monotherapy and in combination with bevacizumab included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines and compendium.
Clinical Pipeline
Published manuscript on the safety and efficacy of mirvetuximab in PROC in the SORAYA trial in the Journal of Clinical Oncology.
Published manuscript on the safety and efficacy of mirvetuximab in combination with bevacizumab in PROC in Gynecologic Oncology.
Completed enrollment in PICCOLO, a single-arm study of mirvetuximab monotherapy in FRα-high recurrent platinum-sensitive ovarian cancer (PSOC).
Presented data from expansion cohorts in the Phase 1b/2 study evaluating the pivekimab sunirine (pivekimab) triplet with Vidaza (azacitidine) and Venclexta (venetoclax) in relapsed/refractory (R/R) and initial data in frontline unfit acute myeloid leukemia (AML) in an oral presentation at the 2022 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December.
Progressed the pivotal Phase 2 CADENZA study of pivekimab sunirine (pivekimab) in frontline and relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Completed dose escalation in the Phase 1 study of IMGC936 in multiple solid tumor types and initiated expansion cohorts in triple-negative breast cancer (TNBC) and non-small cell lung cancer (NSCLC).
Enrolled the first patient in the Phase 1 study of IMGN151 in January 2023.
Corporate Development
Announced a global, multi-target license and option agreement granting Vertex Pharmaceuticals rights to conduct research using ImmunoGen’s ADC technology to discover novel targeted conditioning agents for use with gene editing in exchange for a $15 million upfront payment and up to $337 million in potential option exercise fees, development and commercial milestones, and tiered royalties on a per target basis.
Announced a clinical collaboration with Gilead to evaluate the safety and anti-leukemia activity of pivekimab in combination with magrolimab, a potential first-in-class CD47 inhibitor, in patients with R/R CD123-positive AML.
Appointed Michael Vasconcelles, MD, as Executive Vice President, Research, Development, and Medical Affairs, and Daniel Char, JD, as Senior Vice President and Chief Legal Officer.
ANTICIPATED UPCOMING EVENTS
Report top-line data for MIRASOL in the second quarter of 2023.
Submit the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ELAHERE in FRα-high PROC in the second half of 2023 to support potential approval and launch.
Submit the supplemental Biologics License Application (sBLA) to the FDA in the second half of 2023 to support the conversion of the accelerated approval of ELAHERE to a full approval.
Our partner, Huadong Medicine, to submit the biologics license application (BLA) to the National Medical Products Administration (NMPA) of China for ELAHERE in FRα-high PROC in the second half of 2023 to support potential approval and launch.
Present efficacy data from the SORAYA trial by sequence of treatment and final overall survival analysis at the Society of Gynecologic Oncology (SGO) 2023 Annual Meeting in March.
Report on the primary endpoint for PICCOLO before the end of 2023.
Complete enrollment of the efficacy evaluable cohort of de novo BPDCN patients in the pivotal phase 2 CADENZA study by the end of 2023.
Initiate the combination cohort of pivekimab with magrolimab in R/R AML in collaboration with Gilead in the second half of 2023.
Report dose escalation data in Phase 1 trial of IMGC936 and initial experience in expansion cohorts in the second quarter of 2023.
FINANCIAL RESULTS
Total revenues were $41.2 million for the quarter ended December 31, 2022 compared to $28.0 million for the quarter ended December 31, 2021, and $108.8 million for the year ended December 31, 2022 compared to $69.9 million for the year ended December 31, 2021. The increase in the quarter ended December 31, 2022 was primarily driven by one-time milestone payments achieved pursuant to the Company’s license and collaboration agreements with Huadong Medicine and Viridian Therapeutics. In addition to greater partner milestones achieved, the increase for the current year was driven by one-time license fees received pursuant to agreements executed with Eli Lilly and Magenta Therapeutics in 2022, as well as greater amortization in 2022 of the $40.0 million upfront fee previously received pursuant to the Company’s collaboration agreement with Huadong Medicine. The Company also recorded $2.6 million in net product revenue from sales of ELAHERE for the quarter and year ended December 31, 2022.
Research and development expenses rose to $58.5 million for the quarter ended December 31, 2022 compared to $49.0 million for the quarter ended December 31, 2021, and $213.4 million for the year ended December 31, 2022 compared to $151.1 million for the year ended December 31, 2021. The increases in both periods were driven by greater personnel and temporary staffing costs, external manufacturing costs, and third-party service fees, including medical affairs’ activities in support of the US commercial launch of ELAHERE in the fourth quarter of 2022, as well as greater clinical trial expenses. Additionally, research and development expenses for the year ended December 31, 2022 included $8.9 million of research costs to expand our ADC pipeline, inclusive of a one-time $7.5 million upfront fee paid to Oxford BioTherapeutics.
Selling, general and administrative expenses were $42.1 million for the quarter ended December 31, 2022 compared to $13.6 million for the quarter ended December 31, 2021, and $116.1 million for the year ended December 31, 2022 compared to $43.8 million for the year ended December 31, 2021. The increases in both periods were due primarily to building our commercial infrastructure and capabilities, including personnel-related costs and sales and marketing activities in support of the US launch of ELAHERE in the fourth quarter of 2022.
Net loss for the fourth quarter of 2022 was $59.0 million, or $0.23 per diluted share, compared to net loss of $37.2 million, or $0.17 per diluted share, for the fourth quarter of 2021. Net loss for the year ended December 31, 2022 was $222.9 million, or $0.88 per diluted share, compared to a net loss of $139.3 million, or $0.68 per diluted share, for the year ended December 31, 2021.
ImmunoGen had $275.1 million in cash and cash equivalents as of December 31, 2022, compared with $478.8 million as of December 31, 2021. Cash used in operations was $229.8 million for the year ended December 31, 2022 compared with $169.4 million for the year ended December 31, 2021. Capital expenditures were $1.4 million in each of the years ended December 31, 2022 and 2021.
During the quarter ended December 31, 2022, the Company sold 5.2 million shares of its common stock through its At-the-Market facility, generating net proceeds to the Company of $25.6 million.
FINANCIAL GUIDANCE
For 2023, ImmunoGen expects:
revenues, excluding product revenue from ELAHERE, between $30 million and $35 million; and
operating expenses between $310 million and $320 million.
ImmunoGen expects to provide ELAHERE product revenue guidance later this year.
Excluding anticipated ELAHERE and collaboration revenue, our level of cash and cash equivalents as of December 31, 2022, alone is not sufficient to meet our current operating plans through March 1, 2024. With the addition of forecasted ELAHERE product revenue and milestone payments under existing collaboration agreements, we expect these amounts combined with existing cash and cash equivalents will fund operations for more than 12 months from the date of this release. The Company intends to raise additional funds through equity, debt, or other financings.
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, please register here. A dial-in and unique PIN will be provided to join the call. 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.
ABOUT ELAHERE (MIRVETUXIMAB SORAVTANSINE-GYNX)
ELAHERE (mirvetuximab soravtansine-gynx) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells.
ELAHERE is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test.
This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Eye problems are common with ELAHERE and can be severe. ELAHERE also can cause severe or life-threatening inflammation of the lungs that may lead to death and patients may develop nerve problems called peripheral neuropathy during treatment. Please see full Prescribing Information, including Boxed Warning, and Medication Guide for ELAHERE.