− Conference Call Today at 8:00 am ET−
- Profit reported for quarter, driven by partner activity; Company reiterates previous financial guidance for fiscal year.
- Numerous events expected in 2015 with ImmunoGen and partner product programs.
"We believe the potential of ImmunoGen as a product company will become
more clearly established in 2015, driven by achievements with our most
advanced compounds, IMGN853 and IMGN529," commented
ImmunoGen Wholly Owned Product Candidates
IMGN853 - This ADC is currently in initial (Phase 1b) efficacy testing for the treatment of folate receptor α (FRα)-positive platinum-resistant ovarian cancer and relapsed/refractory endometrial cancer. It is being assessed as a single agent, administered once every three weeks at its recommended Phase 2 dose (RP2D).
The Company is targeting the annual meeting of the
American Society of Clinical Oncology(ASCO) in 2Q2015 for presentation of IMGN853 clinical findings to date.
- ImmunoGen expects to initiate Phase 2 testing in FRα-positive ovarian cancer or endometrial cancer, or both, in 2H2015, pursuing, as appropriate, potential accelerated registration pathways.
- ImmunoGen plans to initiate in 2015 assessment of IMGN853 in combination regimens for the treatment of patients with FRα-positive ovarian cancer.
IMGN529 - This CD37-targeting ADC is a potential new treatment for
diffuse large B-cell lymphoma (DLBCL) and other B-cell malignancies. It
is in dose-finding assessment in patients with non-Hodgkin lymphoma
(NHL), with encouraging evidence of activity in patients with
relapsed/refractory DLBCL presented at the
- The Company expects the RP2D of IMGN529 to be established in 1H2015 and to begin disease-specific testing with IMGN529 in mid-2015.
- ImmunoGen intends to assess IMGN529 specifically for the treatment of DLBCL and of chronic lymphocytic leukemia (CLL).
- The Company plans to report new IMGN529 clinical data at a medical conference in 2H2015.
IMGN289 - This ADC is a potential new treatment for EGFR-positive cancers, which include many head and neck, lung, breast, stomach and esophageal cancers.
- Phase I dose finding is ongoing.
IMGN779 - This CD33-targeting ADC is a potential new treatment for acute myeloid leukemia. It utilizes one of ImmunoGen's new DNA-acting payload agents.
- Data showing IMGN779 is highly active in preclinical models of AML with FLT3-ITD mutations were reported at ASH.
- ImmunoGen expects to submit the Investigational New Drug (IND) application for IMGN779 in 2H2015.
Technology innovations - The Company expects to report information
related to the ongoing expansion of its state-of-the-art technology
portfolio at the
Roche's Kadcyla (ado-trastuzumab emtansine), which uses ImmunoGen's ADC
technology, is the only ADC with full
Sales - Roche reported global Kadcyla sales of
165 million CHFfor its quarter ending December 31, 2014, comprising 69 million CHFin the US and 96 million CHFinternationally. ImmunoGen receives and recognizes royalties on Kadcyla sales in the quarter after the quarter in which Roche records the sales.
- Roche expects the readout from its GATSBY trial in 2015, and - if positive - to apply for marketing approval of Kadcyla for the second-line treatment of advanced HER2-positive gastric cancer.
Roche also expects the data from its
MARIANNEtrial to be presented in 2015; it intends to discuss these data with appropriate regulatory authorities.
- Roche has expanded its Kadcyla clinical program to include assessment for non-small cell lung cancer (NSCLC), starting a Phase 2 trial in late 2014 assessing Kadcyla for second-line/later treatment of advanced HER2-positive NSCLC.
- Patient enrollment continues in the three Phase 3 trials assessing Kadcyla for early stage HER2-positive breast cancer - for neoadjuvant use (KRISTINE), adjuvant use (KAITLIN) and residual invasive disease (KATHERINE).
Other leading companies are advancing clinical-stage compounds that use
ImmunoGen technology - Amgen,
Encouraging Phase 2 data were reported at ASH for Sanofi's
SAR650984and Biotest's indatuximab ravtansine (BT-062). ImmunoGen has an opt-in right with Biotest for the US.
- In January, Novartis advanced its cKit-targeting ADC, LOP628, into clinical testing, triggering a $5 million cash milestone payment to ImmunoGen that will be reflected in the Company's 3QFY2015 financial results.
In 2015, ImmunoGen expects:
- 2-3 partner compounds to advance to IND submission and/or clinical testing in addition to LOP628.
- A number of clinical data presentations on partner compounds.
For the Company's quarter ended
Revenues for 2QFY2015 were
Revenues in 2QFY2015 include
Operating expenses in 2QFY2015 were
ImmunoGen had approximately
Financial Guidance for Fiscal Year 2015
ImmunoGen's financial guidance remains unchanged from that issued in
"Our financial results this quarter reflect our business model of
investing in the development of our own product candidates designed to
make a meaningful difference for patients with cancer, and utilizing
partnerships to help fund these programs," commented
Conference Call Information
ImmunoGen is holding a conference call today at
Kadcyla® is a registered trademark of
This press release includes forward-looking statements based on
management's current expectations. These statements include, but are not
limited to, ImmunoGen's expectations related to: the Company's revenues,
operating expenses, net loss, cash used in operations and capital
expenditures in its 2015 fiscal year; its cash and marketable securities
|SELECTED FINANCIAL INFORMATION|
|(in thousands, except per share amounts)|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||106,604||$||142,261|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Long-term portion of deferred revenue and other long-term liabilities||31,427||68,365|
|Total liabilities and shareholders' equity||$||128,540||$||165,318|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended||Six Months Ended|
|License and milestone fees||$||41,417||$||25,678||$||47,651||$||38,845|
|Research and development support||832||1,922||1,608||3,912|
|Clinical materials revenue||1,426||125||3,453||133|
|Research and development||27,647||20,862||55,665||42,891|
|General and administrative||6,872||5,447||13,967||11,973|
|Total operating expenses||34,519||26,309||69,632||54,864|
|Income (loss) from operations||13,781||3,751||(8,129||)||(7,586||)|
|Other income, net||(146||)||62||(518||)||172|
|Net income (loss)||$||13,635||$||3,813||$||(8,647||)||$||(7,414||)|
|Net income (loss) per common share, basic and diluted||$||0.16||$||0.04||$||(0.10||)||$||(0.09||)|
|Weighted average common shares outstanding, diluted||86,665||87,276||85,904||85,221|
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