*Multiple Data Presentations at Upcoming AACR-NCI-EORTC, San Antonio Breast Cancer Symposium and ASH Meetings
ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops targeted anticancer products using its antibody expertise and Targeted Antibody Payload (TAP) technology, announced financial results for the three-month period ended September 30, 2009 – the first quarter of the Company’s 2010 fiscal year (1QFY10).
“In the next two months, we expect data from five clinical studies to be presented at major medical meetings – the results from the T-DM1 Phase II study that could support a registration filing in 2010 if the findings are compelling, updated clinical data with our IMGN901 compound in the treatment of both CD56-expressing solid tumors and multiple myeloma, and the first clinical findings with SAR3419 and BT-062,” commented Daniel Junius, President and Chief Executive Officer. “This activity reflects the substantial progress being made by us and our partners. It’s gratifying to see TAP compounds being developed and successfully advanced to fight so many different types of cancers. The presentation of clinical findings also expands interest in our pipeline and our technology by potential new partners.”
Mr. Junius continued, “A key focus for us is the prompt advancement of IMGN901 and other high potential programs in our proprietary pipeline. IMGN901 shows promise for the treatment of both solid and liquid tumors, and we’re developing it accordingly. In liquid tumors, we’re evaluating it first for multiple myeloma and are implementing a strategy designed to gain actionable clinical data both when it is administered as a single agent and when used as part of a combination regimen. For solid tumors, we’re using our Study 002 that’s currently underway to obtain key information, and expect to have our development plan for these cancers established in the first half of 2010.”
Recent Highlights
* Clinical findings from the trastuzumab-DM1 (T-DM1) Phase II trial have been accepted for presentation at the San Antonio Breast Cancer Symposium in December 2009. Roche has indicated that, if compelling, these data could enable a T-DM1 marketing application to be filed in 2010.
* Clinical findings with IMGN901 in the treatment of solid tumors have been accepted for presentation at the AACR-NCI-EORTC conference in November 2009, and clinical data with IMGN901, SAR3419 and BT-062 in the treatment of liquid tumors have been accepted for presentation at the American Society of Hematology meeting in December 2009.
* In 1QFY10, ImmunoGen received a $1 million upfront payment from Amgen Inc. in conjunction with its taking its first license to use ImmunoGen’s TAP technology. Companies actively developing at least one TAP compound now include: Amgen, Bayer HealthCare, Biogen Idec, Biotest, Genentech/Roche and sanofi-aventis as well as ImmunoGen.
* In 1QFY10, ImmunoGen earned a milestone payment from Bayer HealthCare with the achievement of an internal development milestone.
* The first preclinical findings with the Company’s second family of payload agents – the IGNs – will be presented at the AACR-NCI-EORTC conference in November.
Financial Results
ImmunoGen reported a net loss of $12.4 million, or $0.22 per basic and diluted share, for 1QFY10 compared to a net loss of $9.4 million, or $0.19 per basic and diluted share, for the same period last year.
Revenues were $3.1 million in 1QFY10, compared to $6.1 million for the same period last year. Revenues in 1QFY10 include $0.8 million of research and development support fees, compared to $3.2 million for the same period last year. The difference is primarily due to a reduction in the amount earned from sanofi-aventis with the conclusion of its committed funding obligations in calendar 2008. Revenues in 1QFY10 also include $1.8 million of license and milestone fees and $0.5 million of clinical material reimbursement, compared to $2.2 million and $0.7 million, respectively, for the same quarter last year.
Operating expenses in 1QFY10 were $15.8 million, compared to $15.5 million in the same period last year. Operating expenses in 1QFY10 include research and development expenses of $12.2 million and general and administrative expenses of $3.6 million, compared to $11.9 million and $3.7 million, respectively, for the same quarter last year.
Other income, net, consisting primarily of interest income, losses/gains recognized on forward contracts and losses realized on investments due to impairment, was $0.1 million in 1QFY10, compared to $16,000 for same period last year.
ImmunoGen had approximately $59.9 million in cash and marketable securities as of September 30, 2009, compared with $71.1 million as of June 30, 2009, and had no debt outstanding in either period. During the first three months of fiscal 2010, cash used in operations was $11.4 million, compared to $2.6 million during the same period in fiscal 2009. The increase in cash used was driven by the greater net loss, the timing of payment of company bonuses and a reduced amount of upfront payments received from partners compared to the same period last year. Capital expenditures were $0.6 million for the first three months of fiscal years 2010 and 2009.
UPDATE ON CLINICAL-STAGE ANTICANCER COMPOUNDS
Trastuzumab-DM1 (T-DM1)
T-DM1 consists of ImmunoGen’s DM1 cancer-cell killing agent linked to the HER2-binding antibody, trastuzumab. It is in global development by the Roche Group.
In its October 15, 2009 quarterly conference call, Roche provided projections on potential regulatory submissions in the US and EU for compounds currently in Phase II/III trials in its pipeline. The projections provided for T-DM1 for the treatment of HER2+ metastatic breast cancer were:
* Potential filing in 2010 for 3rd- and subsequent-line use1 based on Phase II study results.
* Potential filing in 2012 for predominately 2nd-line use2 based on the results of the Phase III trial underway.
* Potential filing after 2012 for 1st-line use. A Phase II trial is underway in this indication.
Findings from the Phase II study evaluating T-DM1 for 3rd- and subsequent-line use are scheduled to be presented at the San Antonio Breast Cancer Symposium on Saturday, December 12, 2009. Encouraging findings from an earlier Phase II study that included 3rd-line use were reported at a medical conference (ASCO) in May 2009.
In addition to the trials evaluating T-DM1 as a single agent, multiple early-stage clinical studies are now underway to assess it as part of different combination regimens, including use with approved chemotherapy agents (paclitaxel and docetaxel) and with other agents in Roche and Genentech’s development portfolio (pertuzumab and GDC-0941).
IMGN901
This TAP compound is wholly-owned by ImmunoGen and consists of the Company’s DM1 attached to its CD56-binding antibody, huN901, using an engineered linker.
IMGN901 is in development for the treatment of CD56+ solid tumors, which include small-cell lung cancer, Merkel cell carcinoma, ovarian and carcinoid/neuroendocrine tumors.
* Clinical findings from the Study 002 solid tumor trial will be presented at the AACR-NCI-EORTC international conference in November 2009.
* The Company expects to establish its solid tumor development plan for IMGN901 by the first half of 2010. This plan will be informed by findings in Study 002.
IMGN901 is also in development for the treatment of CD56+ multiple myeloma.
* Clinical findings from Study 003, which assesses IMGN901 as a single agent for multiple myeloma, will be presented at the American Society of Hematology (ASH) meeting in December 2009.
* Patient enrollment is underway in the Study 003 expansion phase.
* Patient enrollment in Study 005 is expected to begin in the fourth quarter of 2009. This study will assess IMGN901 used in combination with lenalidomide (Revlimid)/low dose dexamethasone.
SAR3419
SAR3419 consists of ImmunoGen’s DM4 cancer-cell killing agent linked to a CD19-binding antibody that was developed and humanized by ImmunoGen. SAR3419 is being developed for the treatment of non-Hodgkin’s lymphoma by sanofi-aventis.
* The first SAR3419 clinical findings will be presented in an oral presentation at the ASH meeting in December.
IMGN388, BT-062 and BIIB015
These are the most recent TAP compounds to enter clinical testing. IMGN388 is in development by ImmunoGen, while BT-062 and BIIB015 are in development by Biotest and Biogen Idec, respectively.
* The first BT-062 clinical findings will be reported at the ASH meeting in December.
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