ImmunoGen Reports First Quarter Fiscal Year 2016 Financial Results and Provides Corporate Update
− Conference Call Today at
- Level of target expression on patient tumors may have a marked impact on response to mirvetuximab soravtansine, ImmunoGen's novel folate receptor α (FRα)-targeting antibody-drug conjugate (ADC); data to be reported at AACR-NCI-EORTC in November.
- Patient enrollment completed in Phase 1 ovarian cancer cohort that ImmunoGen plans to discuss with regulators in 2016. Company on track to initiate trials designed to potentially support an Accelerated Approval pathway (FORWARD I) and market expansion (FORWARD II) for mirvetuximab soravtansine.
- Broader pipeline progress includes advancement of another ImmunoGen ADC and three partner ADCs to IND/clinical testing.
"We believe mirvetuximab soravtansine has the potential to make an
important difference for many patients with FRα-positive cancers and
look forward to the upcoming data presentations at AACR-NCI-EORTC,"
Updates on Product Programs
Mirvetuximab soravtansine (formerly IMGN853) - for FRα-positive cancers including ovarian cancer.
Data presentations at the upcoming
AACR-NCI-EORTC conference will feature:
- Findings from an analysis of the relationship between level of FRα expression on patient tumor cells and response to treatment with mirvetuximab soravtansine (abstract C47). This analysis indicates patients with higher levels of target expression on their tumors are more likely to respond to treatment with mirvetuximab soravtansine. The findings helped inform that FORWARD I would enroll patients with medium or high levels of expression, with stratification by expression level.
- Preclinical evaluation of mirvetuximab soravtansine combination therapy (abstract C170) provides findings on mirvetuximab soravtansine used in combination with bevacizumab (Avastin®) and the other agents to be assessed in FORWARD II.
- Clinical progress: patient enrollment completed - ahead of plan - in the Phase 1 40-patient expansion cohort assessing mirvetuximab soravtansine monotherapy for FRα-positive platinum-resistant ovarian cancer. Patient enrollment is also ahead of plan in the 20-patient ovarian cancer cohort examining biomarkers using biopsies taken before and on treatment, and is progressing in the endometrial cancer expansion cohort. Data presentation for each of these cohorts is targeted for 2Q2016. Cohorts for additional types of FRα-positive cancers are expected to be added to this Phase 1 trial.
- Phase 2 testing: ImmunoGen remains on track to initiate its FORWARD I and FORWARD II trials by year end. FORWARD I evaluates mirvetuximab soravtansine used alone to treat patients with FRα-positive ovarian cancer previously treated with 3-4 regimens and could potentially support an Accelerated Approval pathway. FORWARD II assesses doublet combinations of mirvetuximab soravtansine and bevacizumab (Avastin®), carboplatin, and pegylated liposomal doxorubicin (Doxil®) in less pretreated FRα-positive ovarian cancer.
IMGN529 and coltuximab ravtansine (formerly
- Data presentations at upcoming ASH conference: preclinical findings with each compound used in combination with approved anticancer therapies.
- Clinical progress, Phase 2 testing: maximum tolerated dose identified in single agent, Phase 1 assessment of IMGN529 for B-cell non-Hodgkin lymphoma. Company on track to start Phase 2 assessments of IMGN529 and of coltuximab ravtansine in combination regimens by the end of 2015 and in 2016, respectively.
IMGN779 - CD33-targeting ADC for acute myeloid leukemia and myelodysplastic syndrome; utilizes the first of ImmunoGen's new DNA-acting payload agents.
- Data presentation at upcoming ASH conference: mechanism of action findings.
Clinical progress: IND submitted to
FDA; on track for initiation of patient dosing in early 2016.
Partner compounds - Recent highlights include:
Promising single-agent activity in recurrent mesothelioma from a Phase
1b trial was reported with Bayer's anetumab ravtansine (BAY 94-9343)
at the 16th
World Conference on Lung Cancer.
- Eli Lilly and Company advanced its FGFR3-targeting ADC, LY3076226, into clinical testing in September, triggering a milestone payment to ImmunoGen. Additionally, ImmunoGen earned a milestone payment from Amgen with its advancement of a new ADC.
Patient dosing began with Sanofi's LAMP1-targeting ADC,
SAR428926, in October, also triggering a milestone payment to ImmunoGen.
There are now seven companies with novel anticancer compounds in the
clinic utilizing ImmunoGen's technology: Amgen, Bayer, Biotest,
For the Company's quarter ended
Revenues for 1QFY2016 were
Operating expenses in 1QFY2016 were
ImmunoGen had approximately
Financial Guidance for Fiscal Year 2016
ImmunoGen's financial guidance remains unchanged from that issued in
Conference Call Information
ImmunoGen is holding a conference call today at
ImmunoGen is a clinical-stage biotechnology company that develops targeted anticancer therapeutics with its proprietary antibody-drug conjugate (ADC) technology. The Company's lead product candidate, mirvetuximab soravtansine, is a potential treatment for folate receptor α-positive ovarian cancers and other solid tumors. Leading healthcare companies have licensed rights to use ImmunoGen's technology to develop novel anticancer therapies, and Roche's marketed product, Kadcyla®, utilizes ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.
Avastin®, Doxil®, and Kadcyla® are registered trademarks of their owners.
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 in its 2016 fiscal year; its cash and marketable securities
|SELECTED FINANCIAL INFORMATION|
|(in thousands, except per share amounts)|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||247,843||$||278,109|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Long-term portion of deferred revenue and other long-term liabilities||238,027||242,909|
|Total liabilities and shareholders' equity||$||285,584||$||313,823|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended|
|License and milestone fees||$||6,070||$||6,234|
|Non-cash royalty revenue||5,684||-|
|Research and development support||772||776|
|Clinical materials revenue||2,325||2,027|
|Research and development||35,132||28,018|
|General and administrative||8,329||7,095|
|Total operating expenses||43,461||35,113|
|Loss from operations||(28,610||)||(21,910||)|
|Non-cash interest expense on liability related to sale of future royalty||(5,143||)||-|
|Other income (expense), net||13||(372||)|
|Net loss per common share, basic and diluted||$||(0.39||)||$||(0.26||)|
|Weighted average common shares outstanding, basic and diluted||86,838||85,872|
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