ImmunoGen Reports Recent Progress and 2018 Operating Results
Top-Line Data from Phase 3 FORWARD I Mirvetuximab Soravtansine Study on Track for First Half of 2019
Encouraging Clinical Data from Novel IGN Pipeline Highlighted in Two Oral Presentations at ASH 2018
Sale of Kadcyla® Royalty Tail for
Conference Call to be Held at
“We generated significant momentum in the business during 2018, led by
the completion of enrollment in FORWARD I, our registration study for
mirvetuximab soravtansine in platinum-resistant ovarian cancer; the
publication of combination data in over 100 patients to support label
expansion; and the advancement of our earlier-stage portfolio,” said
- Validation runs were successfully completed and commercial drug product is now in inventory.
- The Premarket Approval (PMA) submission for the folate receptor alpha companion diagnostic was initiated.
- Patient enrollment completed ahead of schedule in the FORWARD II triplet combination cohort evaluating mirvetuximab plus carboplatin and Avastin® (bevacizumab) in patients with recurrent platinum-sensitive ovarian cancer.
Initial safety and preliminary anti-tumor activity from the FORWARD II
expansion cohort assessing mirvetuximab in combination with Merck’s
anti-PD-1 therapy, Keytruda® (pembrolizumab), were
presented at the
European Society for Medical Oncology( ESMO) 2018 Congressin October. Data from this cohort confirm the activity of mirvetuximab in heavily pretreated platinum-resistant ovarian cancer, with a trend toward longer duration of response with the combination than would be expected for mirvetuximab monotherapy. Maturing data from this cohort will guide further development of this novel combination.
IGN Programs and Early-Stage Pipeline
- Both IGN programs received Orphan Drug Designation in acute myeloid leukemia (AML).
Encouraging initial data from the Phase 1 study of IMGN632 in patients
with relapsed or refractory adult AML and blastic plasmacytoid
dendritic cell neoplasm (BPDCN) were presented at the
American Society of Hematology(ASH) Annual Meeting in December. IMGN632 displayed anti-leukemia activity across all dose levels tested and a tolerable safety profile at doses up to 0.3 mg/kg. Enrollment in expansion cohorts is ongoing to identify the recommended Phase 2 dose and schedule for both AML and BPDCN.
- Updated data from the IMGN779 Phase 1 dose finding study in AML patients were also presented at ASH. These data show that IMGN779 continues to display a tolerable safety profile with repeat dosing across a wide range of doses on the two schedules explored in patients with relapsed AML, with anti-leukemia activity seen in both schedules. Enrollment is ongoing to identify the recommended Phase 2 dose and schedule.
IND-enabling activities were initiated during the quarter for IMGC936,
a novel ADAM9-targeting ADC being developed in collaboration with
Multiple abstracts highlighting platform innovations were submitted
for presentation at the 2019 Annual Meeting of the
American Association for Cancer Research.
- Commercial planning and launch readiness activities for mirvetuximab have been initiated to support a potential launch in 2020.
Earlier this month, ImmunoGen announced the 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, for $65 million.
ANTICIPATED 2019 EVENTS
- Report top-line results from Phase 3 FORWARD I trial of mirvetuximab in platinum-resistant ovarian cancer in the first half of 2019, followed by full FORWARD I data presentation at a medical meeting;
- Assuming a positive readout of FORWARD I, submit Biologics License Application (BLA) and Marketing Authorization Application (MAA) for mirvetuximab for the treatment of women with platinum-resistant ovarian cancer in 2H 2019;
- Enroll FORWARD II Avastin cohort in platinum-agnostic ovarian cancer;
- Present initial FORWARD II triplet and mature doublet expansion cohort data;
- 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 for combination studies in AML; and
- Submit an IND for IMGC936 before the end of 2019.
Revenues for the year ended
Operating expenses for 2018 were
ImmunoGen reported a net loss of
For 2019, ImmunoGen expects:
cash and cash equivalents at
December 31, 2019to be between $135 million and $140 million;
$40 million and $45 million; and
operating expenses between
$265 and $270 million.
ImmunoGen expects that its current cash combined with the expected cash receipts from partners and collaborators will enable the Company to fund its operations at least a year beyond the release of top-line results from the Phase 3 FORWARD I trial, which are expected in the first half of 2019.
CONFERENCE CALL INFORMATION
ImmunoGen will hold a conference call today at
ImmunoGen is developing the next generation of antibody-drug conjugates (ADCs) to improve outcomes for cancer patients. By generating targeted therapies with enhanced anti-tumor activity and favorable tolerability profiles, we aim to disrupt the progression of cancer and offer our patients more good days. We call this our commitment to “target a better now.” Our lead product candidate, mirvetuximab soravtansine, is in a Phase 3 study for folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer, and in Phase 1b/2 testing in combination regimens. Our novel IGN candidates for hematologic malignancies, IMGN779 and IMGN632, are in Phase 1 studies.
Learn more about who we are, what we do, and how we do it at www.immunogen.com.
This press release includes forward-looking statements based on management's current expectations. These statements include, but are not limited to, ImmunoGen's expectations related to: the Company's revenues and operating expenses for the twelve months ending
|SELECTED FINANCIAL INFORMATION
(in thousands, except per share amounts)
|CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$||262,252||$||267,107|
|LIABILITIES AND SHAREHOLDERS' DEFICIT|
|Current portion of deferred revenue||$||317||$||1,405|
|Other current liabilities||69,743||54,365|
|Long-term portion of deferred revenue||80,485||93,752|
|Other long-term liabilities||133,264||163,049|
|Shareholders' equity (deficit)||11,942||(17,895||)|
|Total liabilities and shareholders' equity (deficit)||$||295,751||$||294,676|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
|Three Months Ended
|License and milestone fees||$||1,747||$||29,580||$||15,280||$||79,469|
|Non-cash royalty revenue||9,651||7,587||32,524||28,142|
|Research and development support||218||452||1,377||3,482|
|Clinical materials revenue||2,170||1,829||4,635||4,354|
|Research and development||43,111||39,843||173,886||139,739|
|General and administrative||9,722||9,048||36,716||33,911|
|Total operating expenses||53,239||49,284||214,295||174,429|
|Loss from operations||(39,453||)||(9,836||)||(160,479||)||(58,982||)|
|Non-cash interest expense on liability related to sale of future royalty & convertible bonds||(2,428||)||(3,221||)||(10,631||)||(13,682||)|
|Non-cash debt conversion expense||-||(724||)||-||(22,915||)|
|Interest expense on convertible bonds||(25||)||(28||)||(95||)||(3,040||)|
|Other income, net||1,077||691||3,332||2,607|
|Net loss per common share, basic and diluted||$||(0.28||)||$||(0.11||)||$||(1.20||)||$||(0.98||)|
|Weighted average common shares outstanding, diluted||147,287||124,583||139,946||98,068|
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