- Positive Phase III results with trastuzumab emtansine (T-DM1) were presented in a plenary session at ASCO in June; Roche intends to use these data to apply in 2012 for marketing approval of the compound for the use evaluated.
- ImmunoGen expects up to three additional partner compounds to begin pivotal testing in late 2013.
ImmunoGen advanced its third wholly owned product candidate into
clinical testing in
July 2012and remains on track to submit an IND for its fourth compound by mid-2013.
- Recent public stock offering further strengthens ImmunoGen's balance sheet, enhancing the Company's ability to aggressively fund advancement of its proprietary product candidates.
"We believe the trastuzumab emtansine clinical data reported at ASCO
convey the transformational potential of our TAP technology," commented
Product Pipeline Update
Lead compound trastuzumab emtansine, in development globally by Roche:
Most advanced indication — Positive results from Roche's first
trastuzumab emtansine Phase III trial, EMILIA, were presented at
American Society of Clinical Oncology(ASCO) annual meeting in the plenary session. EMILIA assessed trastuzumab emtansine in patients with HER2+ metastatic breast cancer (BC) who previously had been treated with Herceptin® (trastuzumab) and with a taxane. Roche expects to apply in 2012 for marketing approval of trastuzumab emtansine for this use in the US and Europe.
First-line for HER2+ metastatic BC — Patient enrollment has
completed in the Phase III trial, MARIANNE, evaluating trastuzumab
emtansine for this use. Roche expects to use this trial to apply
in 2014 for marketing approval of trastuzumab emtansine for the
first-line treatment of this cancer in the US and
- For early stage HER2+ BC — In early June, Roche outlined its plans to initiate three more trastuzumab emtansine registration trials in 2013, evaluating the compound for neoadjuvant use, for adjuvant use and to treat residual invasive disease following surgery. It anticipates having pathological complete response (pCR) data from the neoadjuvant trial during 2015.
- Most advanced indication — Positive results from Roche's first trastuzumab emtansine Phase III trial, EMILIA, were presented at the 2012
IMGN901, ImmunoGen's lead wholly owned compound:
For first-line treatment of small-cell lung cancer (SCLC) —
Patient enrollment is ongoing in the NORTH Phase II trial, with 28
sites now open. The Company expects to be able to use this trial
to make the decisions necessary to advance IMGN901 into pivotal
Additionally, ImmunoGen expects to report clinical findings on the IMGN901 dose established for use in combination with etoposide/carboplatin at the
ChicagoMultidisciplinary Symposium in Thoracic Oncology in early September. The patient population for this Phase I evaluation was not limited to first-line SCLC.
- For relapsed multiple myeloma — The Company expects to report findings from the Phase I trial assessing IMGN901 used in combination with Revlimid® (lenalidomide)/ dexamethasone at a medical conference in late 2012.
- For first-line treatment of small-cell lung cancer (SCLC) — Patient enrollment is ongoing in the NORTH Phase II trial, with 28 sites now open. The Company expects to be able to use this trial to make the decisions necessary to advance IMGN901 into pivotal testing.
IMGN853, ImmunoGen's wholly owned folate receptor α (FOLR)-targeting
TAP compound, began clinical testing in
June 2012. Its Phase I trial is designed to first define IMGN853's maximum tolerated dose and dose-limiting toxicity and then to evaluate it to treat specific types of FOLR-overexpressing cancers. ImmunoGen expects to be able to use this trial to make the decisions necessary to advance IMGN853 into pivotal testing.
IMGN529, ImmunoGen's wholly owned TAP compound for the treatment of
CD37+ hematologic malignancies, entered clinical testing in
April 2012for the treatment of previously treated non-Hodgkin's lymphoma. The Company expects to report the first clinical data with IMGN529 in 2013.
Other clinical-stage compounds — In addition to trastuzumab emtansine,
seven other compounds are in clinical testing through ImmunoGen's
- The Company expects up to three of these compounds to advance into pivotal testing by late 2013.
SAR3419— Encouraging Phase I data were reported with SAR3419at ASCO. ImmunoGen believes the first Phase II data with this CD19-targeting TAP compound could be presented at a medical meeting in late 2012.
Fiscal Year 2012 Financial Results
For the Company's fiscal year ended
Revenues in FY2012 were
Operating expenses in FY2012 were
Other (expense) income, net, was
Cash used in operations was
ImmunoGen had approximately
Financial Guidance for FY 2013
ImmunoGen expects its net loss for its fiscal year ending
"Roche, Sanofi and the rest of our partners are making tangible progress
with compounds that can generate meaningful revenue to ImmunoGen,"
Conference Call Information
ImmunoGen is holding a conference call today at
Herceptin® is a registered trademark of
Revlimid® is a registered trademark of Celgene Corporation.
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||$||160,938||$||191,206|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Long-term portion of deferred revenue and other long-term liabilities||80,164||63,106|
|Total liabilities and shareholders' equity||$||180,308||$||217,641|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended||Fiscal Year Ended|
|Research and development support||$||1,184||$||1,566||$||4,517||$||7,256|
|License and milestone fees||950||2,859||9,161||6,393|
|Clinical materials revenue||818||2,080||2,679||5,656|
|Research and development||19,539||18,261||69,192||63,453|
|General and administrative||5,726||4,438||20,422||16,040|
|Total operating expenses||25,265||22,699||89,614||79,493|
|Loss from operations||(22,313||)||(16,194||)||(73,257||)||(60,188||)|
|Other (expense) income, net||(101||)||44||(62||)||1,914|
|Net loss per common share, basic and diluted||$||(0.29||)||$||(0.23||)||$||(0.95||)||$||(0.85||)|
|Weighted average common shares outstanding, basic and diluted||77,416||71,315||76,814||68,919|
Executive Director, Investor Relations and Corporate Communications
The Yates Network
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