ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that
develops targeted antibody-based anticancer products using its
antibody expertise and Targeted Antibody Payload (TAP) technology,
today reported financial results for the three-month period ended
December 31, 2010 – the second quarter of the Company’s 2011 fiscal
year (2QFY2011).
“We expect significant progress across a number of programs
during 2011,” said Daniel Junius, President and CEO. “New clinical
data are expected to be reported for multiple product candidates,
including IMGN901, T-DM1, and SAR3419, and several TAP compounds
are anticipated to advance into Phase II testing later this year.
We plan to disclose the first details on our lead preclinical
compounds – IMGN529 and IMGN853 – at a scientific conference in
early 2011 and to submit their INDs in mid-2011 and early 2012,
respectively. Three additional partner compounds are on track to
enter the clinic in 2011. We also continue to expand our technology
portfolio and expect to discuss additional enhancements later this
year.”
ImmunoGen Product Candidates – Highlights
IMGN901 (lorvotuzumab mertansine) – in clinical testing for
treatment of CD56+ solid tumors and multiple myeloma (MM).
- Reported encouraging initial clinical
data for IMGN901 used in combination with lenalidomide (Revlimid®)
and dexamethasone to treat relapsed MM at ASH. Additionally,
presented updated clinical data for IMGN901 used as a single agent
to treat this disease.
- Initiated a Phase I/II trial to assess
IMGN901, used in combination with carboplatin plus etoposide, for
the first-line treatment of small-cell lung cancer (SCLC).
- Determined that IMGN901 is best
assessed in Merkel cell carcinoma (MCC) in a pivotal trial when
administered first line in combination with carboplatin plus
etoposide. The Company plans to use the dose identified in the
dose-finding phase of the first-line combination trial in SCLC for
assessment of IMGN901 in MCC.
- IMGN901 has received orphan drug
designation for MM in the US and a favorable opinion from the EMA
for this designation in Europe. The compound already has orphan
drug designation for SCLC and MCC in the US and Europe.
IMGN388 – in clinical testing for treatment of solid tumors
- Reported updated clinical data from the
dose-finding assessment of administration of IMGN388 every three
weeks, which are supportive of evaluating a more frequent dosing
schedule.
- The Company expects to report data from
a more frequent dosing schedule in 2H2011.
IMGN529 – in preclinical development for types of liquid
tumors
- The Company expects to disclose
information related to this compound, including preclinical data,
at a scientific conference in 2Q2011.
- ImmunoGen plans to submit an IND for
this TAP compound in mid-2011.
IMGN853 – in preclinical development for ovarian and other
epithelial cancers
- Reported data on its target, folate
receptor 1, at a scientific conference in November.
- The Company expects to disclose
preclinical data and other information related to this compound at
a scientific conference in 2Q2011.
- ImmunoGen intends to submit an IND for
this TAP compound in early 2012.
Partner Product Candidates – Highlights
Trastuzumab-DM1 (T-DM1) – in global development by Roche for the
treatment of HER2+ breast cancer (BC), including two Phase III
trials for metastatic disease and a Phase II trial in the
adjuvant/neoadjuvant setting.
- Announced the Phase II clinical data
for T-DM1 used in combination with pertuzumab in the first-line
treatment of advanced HER2+ BC presented in December.
- Roche expects progression-free survival
(PFS) data from the Phase II trial assessing T-DM1 compared with
Herceptin plus docetaxel for first-line treatment of advanced HER2+
BC in 3Q2011.
SAR3419, SAR650984, and SAR566658 – in development by
sanofi-aventis from a previous research collaboration with
ImmunoGen.
- Sanofi-aventis expects to report new
SAR3419 Phase I clinical data in 2Q2011 and to begin Phase II
evaluation on this TAP compound in 2H2011. Trials assessing SAR3419
in combination with other anticancer agents are also expected to be
initiated in 2011.
- SAR650984 and SAR566658 continue in
Phase I clinical testing.
BT-062 – in development by Biotest
- Updated Phase I clinical data in
multiple myeloma and promising preclinical data in solid tumors
were reported at international conferences in 4Q2010.
BIIB015 – in development by Biogen Idec
- Currently in Phase I testing, BIIB015
is among the oncology assets Biogen Idec expects to spin off or
sell.
ImmunoGen expects 2-3 additional TAP compounds to enter the
clinic in 2011 through the Company’s collaborative partners.
Financial Results
ImmunoGen reported a net loss of $14.2 million, or $0.21
per basic and diluted share, for 2QFY2011 as compared to a net loss
of $13.0 million, or $0.23 per basic and diluted share, for
the same period last year.
Revenues were $4.2 million for 2QFY2011, as compared to
$3.1 million for the same period last year. Revenues in
2QFY2011 include $2.0 million of research and development
support fees and $1.3 million of clinical material
reimbursement, compared to $1.3 million and $1.0 million,
respectively, for the same quarter last year. Revenues in 2QFY2011
also include $0.9 million of license and milestone fees, compared
to $0.8 million for the same quarter last year.
Operating expenses for 2QFY2011 were $19.7 million, compared to
$16.1 million in the same period last year. Operating expenses in
2QFY2011 include research and development expenses of
$16.0 million, compared to $12.2 million in 2QFY2010. The
increase in the current period is primarily due to greater
investment being made in the Company’s development of its
proprietary product candidates, including costs associated with the
enrollment of more patients in clinical trials and the advancement
of IMGN529 and IMGN853 toward IND filing. The operating expenses
also include general and administrative expenses of
$3.7 million in 2QFY11, compared to $3.9 million in
2QFY2010.
Other income (expense), net, was $1.3 million in 2QFY2011,
compared to $(19,000) for the same period last year. Included in
other income in the current period 2QFY2011 is $1.2 million of
federal grant funding the Company was awarded in 2QFY2011 under the
Patient Protection and Affordable Care Act of 2010 to develop new
anticancer therapies. The Company had received $1.1 million of this
amount as of December 31, 2010.
ImmunoGen had approximately $128.5 million in cash and
marketable securities as of December 31, 2010, compared with $110.3
million as of June 30, 2010, and had no debt outstanding in
either period. Cash provided by operations was $18.4 million
in the first six months of the Company’s 2011 fiscal year,
comparing with $20.3 million of cash used in operations during the
same period in fiscal 2010. This $38.7 million difference is driven
principally by the $45 million upfront payment received from
Novartis in 2QFY2011 with the establishment of a technology access
collaboration between the companies. Capital expenditures were $0.9
million for the first six months of both fiscal years 2011 and
2010.
Financial Guidance
ImmunoGen expects its net loss for its fiscal year ending June
30, 2011 to be between $60-64 million, its cash used in operations
to be between $0-4 million, and its capital expenditures to be
between $2-3 million – all unchanged from previous guidance. Cash
and marketable securities at June 30, 2011 are anticipated to
be between $106-110 million, also unchanged from previous
guidance.
“We’re focused on developing novel anticancer compounds and
aggressively advancing them to value-inflection points, while using
business development as a source of non-dilutive financing,” said
Gregory Perry, Senior Vice President and CFO.
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics using
the Company's expertise in tumor biology, monoclonal antibodies and
potent cancer-cell killing agents. The Company's TAP technology
uses monoclonal antibodies to deliver one of ImmunoGen's
proprietary cancer-cell killing agents specifically to tumor cells.
There are currently seven TAP compounds in the clinic, with a
wealth of clinical data reported with the technology. ImmunoGen’s
collaborative partners include Amgen, Bayer Schering Pharma, Biogen
Idec, Biotest, Genentech (a member of the Roche Group), Novartis,
and sanofi-aventis. The most advanced compound using ImmunoGen's
TAP technology, trastuzumab-DM1 (T-DM1), is in Phase III testing
through the Company's collaboration with Genentech. More
information about ImmunoGen can be found at www.immunogen.com.
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 2011 fiscal year; its cash and marketable
securities as of June 30, 2011; the occurrence, timing and outcome
of potential pre-clinical, clinical and regulatory events related
to the Company's and its collaboration partners' product programs;
and the presentation of preclinical and clinical data on the
Company’s and collaboration partners’ product candidates. For these
statements, ImmunoGen claims the protection of the safe harbor for
forward-looking statements provided by the Private Securities
Litigation Reform Act of 1995. Various factors could cause
ImmunoGen's actual results to differ materially from those
discussed or implied in the forward-looking statements, and you are
cautioned not to place undue reliance on these forward-looking
statements, which are current only as of the date of this release.
Factors that could cause future results to differ materially from
such expectations include, but are not limited to: the timing and
outcome of ImmunoGen's and the Company's collaboration partners'
research and clinical development processes; the difficulties
inherent in the development of novel pharmaceuticals, including
uncertainties as to the timing, expense and results of preclinical
studies, clinical trials and regulatory processes; ImmunoGen's
ability to financially support its product programs; ImmunoGen's
dependence on collaborative partners; industry merger and
acquisition activity; and other factors more fully described in
ImmunoGen's Annual Report on Form 10-K for the fiscal year ended
June 30, 2010 and other reports filed with the Securities and
Exchange Commission.
IMMUNOGEN, INC. SELECTED FINANCIAL INFORMATION (in
thousands, except per share amounts)
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited) December 31, June 30,
2010
2010 ASSETS Cash, cash equivalents and marketable
securities $ 128,486 $ 110,298 Other assets 25,319
26,910 Total assets $ 153,805 $ 137,208
LIABILITIES AND SHAREHOLDERS' EQUITY Current
liabilities $ 10,738 $ 13,822 Long-term portion of deferred revenue
and other long-term liabilities 64,890 21,338 Shareholders' equity
78,177 102,048 Total liabilities
and shareholders' equity $ 153,805 $ 137,208
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (Unaudited) Three Months Ended Six
Months Ended December 31, December 31,
2010 2009 2010 2009
Revenues: Research and development support $ 2,005 $ 1,283 $
3,500 $ 2,065 License and milestone fees 866 827 2,676 2,658
Clinical materials reimbursement 1,307 998
1,413 1,484 Total
revenues 4,178 3,108 7,589
6,207 Expenses: Research and
development 16,004 12,211 29,429 24,399 General and administrative
3,688 3,886 7,052
7,478 Total operating expenses 19,692
16,097 36,481 31,877
Loss from operations (15,514 ) (12,989 ) (28,892 ) (25,670 )
Other income (expense), net
1,281 (19 ) 1,771 125
Loss before taxes (14,233 ) (13,008 ) (27,121 )
(25,545 ) (Benefit)/provision for income taxes -
- - (162 ) Net
loss $ (14,233 ) $ (13,008 ) $ (27,121 ) $ (25,383 )
Net
loss per common share, basic and diluted $ (0.21
) $ (0.23 ) $ (0.40
) $ (0.44 ) Average
common shares outstanding, basic and diluted
67,965 57,156
67,961 57,094
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