ImmunoGen Reports Recent Progress and First Quarter 2017 Operating Results
Phase 3 FORWARD I Trial of Mirvetuximab Soravtansine Activated in
Data at AACR and SGO Annual Meetings Highlight Patient Selection Strategy for FORWARD I and Breadth of ADC Expertise
Mirvetuximab Soravtansine Safety and Efficacy Data to be Presented at ASCO Annual Meeting
Conference Call to be Held at
"We have started 2017 with significant progress towards our strategic
priorities of advancing our portfolio, supporting our partners, and
driving continued innovation in ADCs," said
Treated the first patient in FORWARD I and expanded the study to more
than 40 sites in
North Americaand Europe;
Presented expanded Phase 1 data from the biopsy cohort for
mirvetuximab soravtansine at the
Society for Gynecologic Oncology(SGO) Annual Meeting on Women's Cancer demonstrating that archival tumor tissue can reliably identify patients with folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer and supporting the patient selection strategy for FORWARD I; and
Delivered nine presentations at the
American Association for Cancer Research(AACR) Annual Meeting demonstrating improvements to ImmunoGen's payload and linker technologies and highlighting data with novel ADCs directed to a range of tumor targets.
- Bayer completed enrollment in a registration-enabling Phase 2 study for anetumab ravtansine in mesothelioma; and
- Takeda initiated preclinical development with the first ADC using ImmunoGen's IGN platform directed to a solid tumor.
ImmunoGen will report data on mirvetuximab soravtansine in poster
presentations at the 2017
Location: Hall A
- Title: Mirvetuximab soravtansine (IMGN853), a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in platinum-resistant epithelial ovarian cancer (EOC) patients (pts): Activity and safety analyses in phase I pooled expansion cohorts. (Abstract No.: 5547, Poster Board No.: 369)
- Title: Safety findings from FORWARD II: A phase 1b study evaluating the folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC) mirvetuximab soravtansine (IMGN853) in combination with bevacizumab, carboplatin, pegylated liposomal doxorubicin (PLD), or pembrolizumab in patients (pts) with ovarian cancer. (Abstract No.: 5553, Poster Board No.: 375)
- Title: FORWARD I (GOG 3011): A randomized phase 3 study to evaluate the safety and efficacy of mirvetuximab soravtansine (IMGN853) versus chemotherapy in adults with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian cancer (EOC), primary peritoneal cancer, or primary fallopian tube cancer. (Abstract No.: TPS5607, Poster Board No.: 425b)
Additional Upcoming Events
- ImmunoGen expects to present initial Phase 1 data for IMGN779, a CD33-targeting ADC, for the treatment of acute myeloid leukemia in mid-2017. These will be the first clinical data reported with an ADC using ImmunoGen's DNA-alkylating payload.
- The Company anticipates filing an investigational new drug (IND) application in the third quarter of 2017 to support clinical testing with IMGN632, a CD123-targeting ADC integrating a more potent DNA-alkylating payload intended to treat a range of hematological malignancies.
- ImmunoGen also anticipates advancing the first development candidate under its collaboration with CytomX into preclinical development in 2017.
Revenues for the quarter ended
Operating expenses for the first quarter of 2017 were
ImmunoGen reported a net loss of
ImmunoGen had approximately
ImmunoGen's financial guidance for 2017 remains unchanged from that
$70 millionand $75 million, which includes $28 millionof expected upfront and milestone fees from partners;
Operating expenses between
$175 millionand $180 million; and
Cash and cash equivalents at
December 31, 2017between $35 millionand $40 million.
ImmunoGen expects that its current cash plus expected cash revenues from partners and collaborators will enable the Company to fund operations into the second quarter of 2018.
Conference Call Information
ImmunoGen will hold a conference call today at
ImmunoGen is a clinical-stage biotechnology company that develops targeted cancer therapeutics using its proprietary ADC technology. ImmunoGen's lead product candidate, mirvetuximab soravtansine, is in a Phase 3 trial for FRα-positive platinum-resistant ovarian cancer, and is in Phase 1b/2 testing in combination regimens for earlier-stage disease. ImmunoGen's ADC technology is used in Roche's marketed product, Kadcyla®, in three other clinical-stage ImmunoGen product candidates, and in programs in development by partners Amgen, Bayer, Biotest, CytomX, Lilly, Novartis, Sanofi and Takeda. More information about the Company can be found at www.immunogen.com.
Kadcyla® is a registered trademark of
This press release includes forward-looking statements based on
management's current expectations. These statements include, but are not
limited to, ImmunoGen's expectations related to: the Company's revenues,
operating expenses, net loss, cash used in operations and capital
expenditures for the twelve months ending
SELECTED FINANCIAL INFORMATION
(in thousands, except per share amounts)
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||126,568||$||159,964|
|LIABILITIES AND SHAREHOLDERS' DEFICIT|
|Long-term portion of deferred revenue and other long-term liabilities||290,484||295,938|
|Total liabilities and shareholders' deficit||$||163,321||$||198,864|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended|
|License and milestone fees||$||18,730||$||10,077|
|Non-cash royalty revenue||7,613||7,380|
|Research and development support||1,665||1,059|
|Clinical materials revenue||678||1,198|
|Research and development||33,070||36,094|
|General and administrative||8,119||11,235|
|Total operating expenses||41,575||47,329|
|Loss from operations||(12,889)||(27,615)|
|Non-cash interest expense on liability related to sale of future royalty & convertible bonds||(3,575)||(4,972)|
|Interest expense on convertible bonds||(1,125)||-|
|Other income, net||249||659|
|Net loss per common share, basic and diluted||$||(0.20)||$||(0.37)|
|Weighted average common shares outstanding, basic and diluted||87,160||87,035|
View source version on businesswire.com: http://www.businesswire.com/news/home/20170505005126/en/
FTI Consulting, Inc.
Robert Stanislaro, 212-850-5657
News Provided by Acquire Media