ImmunoGen, Inc. Reports Second Quarter Fiscal Year 2013 Financial Results and Provides Quarterly Update
Trastuzumab emtansine (T-DM1) marketing applications are under
review in the US and
Europe; US application has priority review status with a PDUFA date of February 26, 2013.
- In 2013, ImmunoGen expects to report clinical findings with its three lead wholly owned compounds and to advance its fourth compound, IMGN289, into clinical testing.
- Clinical findings also are expected to be reported for multiple partner compounds, with next compound on track to advance into pivotal testing in 2013.
"We expect 2013 to be a very important year for ImmunoGen," commented
Product Pipeline Update
Lead compound with ImmunoGen's TAP technology, T-DM1, is in global
development by Roche:
The T-DM1 marketing applications for treatment of people with
HER2+, unresectable locally advanced or metastatic breast cancer
who have received prior treatment with Herceptin® (trastuzumab)and a taxane are under review in the US and
Europe. Roche has noted that the US submission has been granted priority review status by the FDAwith a PDUFA goal date of February 26, 2013. Roche also expects European approval of T-DM1 in 2013.
- Roche expects to report data from its Ph III trial, MARIANNE, evaluating T-DM1 for first-line treatment of HER+ metastatic breast cancer in early 2014 and to apply for marketing approval for this use in 2014.
- Roche intends to initiate registration trials in 2013 evaluating T-DM1 in three early stage HER2+ breast cancer settings — adjuvant, neoadjuvant, and residual invasive disease.
- Roche is currently evaluating T-DM1 for the treatment of advanced HER2+ gastric cancer and expects to submit for approval for this use in 2015.
- The T-DM1 marketing applications for treatment of people with HER2+, unresectable locally advanced or metastatic breast cancer who have received prior treatment with Herceptin® (trastuzumab)and a taxane are under review in the US and
IMGN901, wholly owned ImmunoGen TAP compound for CD56+ cancers:
- Small-cell lung cancer (SCLC) — The Company remains on track to have the data readout from the first stage of its Simon two-stage NORTH Phase II trial in the second half of 2013 — a readout designed to inform certain development decisions to be made by the Company. ImmunoGen expects to complete patient enrollment for the full trial in 2013, which would enable these findings to be reported in 2014. NORTH evaluates IMGN901 for the first-line treatment of SCLC used in combination with etoposide/carboplatin.
- Multiple myeloma — IMGN901 showed activity in both Revlimid® (lenalidomide)-naïve and -refractory disease in a Phase I trial assessing it used in combination with Revlimid and dexamethasone presented at the ASH annual meeting in December.
IMGN853, ImmunoGen TAP compound for folate receptor α
- The Company expects the first clinical data with this TAP compound to be reported at a medical conference in mid-2013.
- IMGN853 is a potential treatment for prevalent types of ovarian and non-small cell lung cancers, as well as for other FOL+ solid tumors.
IMGN529, ImmunoGen TAP compound for CD37+ hematological malignancies:
- IMGN529 is in Phase I testing for the treatment of non-Hodgkin's lymphoma, and the Company expects the first clinical data to be reported at a medical conference in late 2013.
- IMGN529 employs ImmunoGen's TAP technology with an antibody that also has anticancer properties.
IMGN289, ImmunoGen TAP compound for EGFR-overexpressing solid tumors:
- IMGN289 is expected to be the next wholly owned ImmunoGen compound to advance into clinical testing. The Company expects to submit its IND in mid-2013 and to begin clinical testing in 2H 2013.
- ImmunoGen expects to present data on the preclinical efficacy and tolerability of IMGN289 at a scientific meeting in 2Q 2013.
In addition to T-DM1, seven other compounds are in clinical testing
through ImmunoGen's partnerships:
- Clinical data are expected to be reported with a number of these compounds in 2013.
- A partner compound is projected to advance into pivotal testing in 2013.
Financial Results and Guidance
ImmunoGen reported a net loss of
Revenues for 2Q FY2013 were
Operating expenses for 2Q FY2013 were
ImmunoGen had approximately
ImmunoGen's financial guidance remains unchanged from that issued in
"The expected approval and launch of T-DM1 will be an important
milestone in ImmunoGen's history," commented
Conference Call Information
ImmunoGen is holding a conference call today at
Herceptin® 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 net loss,
cash used in operations and capital expenditures in its 2013 fiscal
year; its cash and marketable securities as of
|SELECTED FINANCIAL INFORMATION|
|(in thousands, except per share amounts)|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
Cash and cash equivalents
|LIABILITIES AND SHAREHOLDERS' EQUITY|
Long-term portion of deferred revenue and other long-term liabilities
Total liabilities and shareholders' equity
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
Three Months Ended
Six Months Ended
Research and development support
License and milestone fees
Clinical materials reimbursement
Research and development
General and administrative
Total operating expenses
|Loss from operations||(24,508||)||(12,776||)||(49,756||)||(32,242||)|
Other income, net
|Net loss per common share, basic and diluted||$||(0.29||)||$||(0.17||)||$||(0.59||)||$||(0.42||)|
|Weighted average common shares outstanding, basic and diluted||84,147||76,523||83,748||76,443|
Executive Director, Investor Relations
and Corporate Communications
The Yates Network
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