ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that
develops targeted anticancer products using its antibody expertise
and Targeted Antibody Payload (TAP) technology, today announced
financial results for the three-month period ended December 31,
2009 – the second quarter of the Company’s 2010 fiscal year
(2QFY10).
“This past quarter was possibly ImmunoGen’s most significant to
date,” commented Daniel Junius, President and CEO. “The positive
clinical data reported with T-DM1 at the San Antonio Breast Cancer
Symposium in December and with our IMGN901 compound at
AACR-NCI-EORTC conference in November demonstrate the power of our
TAP technology to make a real difference for patients with solid
tumor cancers. We look forward to Genentech* discussing the T-DM1
data with the FDA, and to their evaluating next steps. We’re also
pleased with the progress Genentech and Roche are making to expand
the pivotal testing of T-DM1 into earlier stages of HER2-expressing
breast cancer. The findings with IMGN901 support expanding its
assessment for CD56-expressing solid tumors, and we’re now
exploring the initiation of IMGN901 pivotal testing in 2011.”
Mr. Junius continued, “Favorable results also were reported with
TAP compounds for the treatment of liquid tumors. The IMGN901
clinical data presented at the ASH meeting in December support
further evaluation of this compound for use as a single agent to
treat multiple myeloma and also its evaluation as part of a
combination regimen, both of which we’re pursuing. The initial
findings reported with SAR3419 and BT-062 in the treatment of
non-Hodgkin’s lymphoma and multiple myeloma, respectively, also
were highly encouraging.”
Clinical Pipeline Highlights
Trastuzumab-DM1 (T-DM1)
- For 3rd-line1 treatment of HER2+
metastatic breast cancer (MBC) – Positive clinical data were
reported in December from the Phase II trial evaluating T-DM1 for
this use, and Genentech noted its plans to discuss the data with
the FDA. This is consistent with previous statements made by
Genentech, which had said that if the findings from this trial were
compelling, it would discuss an earlier approval pathway with the
FDA. Additional data from this study are expected to be presented
at an upcoming medical meeting.
- For 2nd-line2 treatment of HER2+
MBC – Patient enrollment is on track in the Phase III trial
(EMILIA) evaluating T-DM1 for this use.
- For 1st-line treatment of HER2+
MBC – Patient enrollment has been completed in the Phase II trial
evaluating T-DM1 for this use, interim data from this trial are
expected to be submitted for presentation at a medical meeting this
year, and a 1st-line Phase III trial is targeted to begin
mid-2010.
IMGN901
- For treatment of CD56+ solid
tumors – The maximum tolerated dose (MTD) was established in the
Phase I trial evaluating IMGN901 for the treatment of CD56+ solid
tumors, and encouraging clinical data from this study were reported
at a medical meeting in November 2009. The expansion phase of this
study, which is underway, focuses on evaluating IMGN901 in cancers
of particular interest – small-cell lung cancer, Merkel cell
carcinoma, and ovarian cancer. The Company expects to report its
development plan for IMGN901 in solid tumors in 1H2010.
- For treatment of CD56+ multiple
myeloma (MM) – The MTD also has been established in the Phase I
trial evaluating IMGN901 as a single agent for heavily pretreated
MM, and encouraging clinical data were reported at a medical
meeting in December 2009. Patient dosing is underway in the
expansion phase of this trial, which evaluates the compound in less
heavily pretreated patients. Patient recruitment also is underway
in a Phase I trial evaluating IMGN901 for MM when used in
combination with lenalidomide (Revlimid®) and dexamethasone.
SAR3419
- For treatment of CD19+
relapsed/refractory non-Hodgkin’s lymphoma – Encouraging findings
were reported at a medical meeting in December 2009 from a Phase I
trial evaluating SAR3419 when dosed every three weeks. A weekly
dosing study also is underway. ImmunoGen expects SAR3419 to advance
into Phase II in 2H2010.
BT-062
- For treatment of multiple
myeloma – Favorable clinical data were reported at a medical
meeting in December 2009 from a Phase I trial evaluating BT-062
when dosed every three weeks. A clinical trial that explores a more
frequent dosing regimen has been filed with the FDA.
IMGN388, BIIB015
- For treatment of different types
of solid tumors – Abstracts with the first clinical findings with
these compounds were submitted to the American Society of Clinical
Oncology (ASCO) for presentation at the annual meeting in
2Q2010.
Clinical Pipeline Expansion
- ImmunoGen expects two additional
compounds to advance into clinical testing in 2010 through the
Company’s collaboration with sanofi-aventis.
Financial Results
ImmunoGen reported a net loss of $13.0 million, or $0.23 per
basic and diluted share, for 2QFY10 compared to a net loss of $7.1
million, or $0.14 per basic and diluted share, for the same period
last year.
Revenues were $3.1 million in 2QFY10, compared to $9.3 million
for the same period last year. Revenues in 2QFY10 include $1.3
million of research and development support fees, compared to $2.3
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 the second
quarter of ImmunoGen's 2009 fiscal year. Revenues in 2QFY10 also
include $0.8 million of license and milestone fees and $1.0 million
of clinical material reimbursement, compared to $4.8 million and
$2.3 million, respectively, for the same quarter last year. The
prior year period included a $4 million payment earned with
the achievement of a clinical milestone by a partner.
Operating expenses in 2QFY10 were $16.1 million, compared to
$16.4 million in the same period last year. Operating expenses in
2QFY10 include research and development expenses of $12.2 million
and general and administrative expenses of $3.9 million, compared
to $12.9 million and $3.5 million, respectively, for the same
quarter last year.
ImmunoGen had approximately $52.4 million in cash and marketable
securities as of December 31, 2009, compared with $71.1
million as of June 30, 2009, and had no debt outstanding in
either period. During the first six months of fiscal 2010, cash
used in operations was $20.3 million, compared to $0.4 million
during the same period last year. The increase in cash used was
driven by the greater net loss, the timing of payment of incentive
compensation, and a reduced amount of upfront payments received
from partners compared to the same period last year. Capital
expenditures were $0.9 million for the first six months of fiscal
year 2010 compared to $1.0 million for the same period in fiscal
2009.
Financial Guidance
ImmunoGen expects its net loss for its fiscal year ending June
30, 2010 to be between $53-56 million, compared to previous
guidance of $44-47 million. The Company expects its cash used in
operations to be between $38-41 million, compared to previous
guidance of $32-35 million. Capital expenditures are anticipated to
be between $1-2 million, unchanged from previous guidance. Cash and
marketable securities at June 30, 2010 are anticipated to be
between $33-35 million, compared to previous guidance of
$38-40 million.
“Our updated guidance reflects changes in the expected timing of
certain milestone payments and expenses,” commented Gregory Perry,
Senior Vice President and Chief Financial Officer. “While we
continue to closely manage our expenses, we’re accelerating certain
investments in IMGN901 clinical supplies – moving them forward into
our 2010 fiscal year – to ensure that the availability of materials
doesn’t become limiting to the aggressive clinical program we’re
implementing.”
Mr. Perry continued, “Driven principally by data from our and
our partners’ clinical trials, we’re seeing substantially greater
interest in our TAP technology and proprietary product programs. We
continue to expect that business development can be a source of
non-dilutive financing for ImmunoGen in 2010.”
About ImmunoGen’s Targeted Antibody Payload (TAP)
Technology
We use tumor-targeting manufactured antibodies to deliver one of
our highly potent cell-killing agents specifically to cancer cells
to kill tumors while avoiding the damage to healthy tissue seen
with untargeted therapies.
Our cell-killing agents (e.g., DM1, DM4) are 1,000 – 10,000-fold
more potent than traditional chemotherapy drugs and are designed
for attachment to antibodies using one of our engineered linkers.
Our linkers keep the cell-killing agent attached to the antibody
while it is traveling through the bloodstream to the tumor sites
and control the agent’s release and activation once inside a cancer
cell.
We use our cell-killing agents and linkers with our own
antibodies to create compounds for our own product pipeline. We
also outlicense our technology.
About the Pipeline Compounds Discussed
T-DM1 consists of our DM1 cell-killing agent attached to
Genentech’s HER2-targeting antibody, trastuzumab, and was created
under a technology license between the companies. T-DM1 is in
global development by Genentech and Roche.
IMGN901 consists of our DM1 attached to our CD56-targeting
antibody. It is wholly owned by ImmunoGen and is a potential
treatment for CD56+ cancers, including small-cell lung cancer,
Merkel cell carcinoma, ovarian cancer, carcinoid/neuroendocrine
tumors, and multiple myeloma.
SAR3419 consists of our DM4 attached to a CD19-targeting
antibody developed by ImmunoGen. We licensed SAR3419 to
sanofi-aventis as part of a broader collaboration and it is in
development by sanofi-aventis.
BT-062 consists of our DM4 attached to Biotest’s CD138-targeting
antibody. It is in development by Biotest. ImmunoGen has certain
opt-in rights to this compound.
IMGN388 consists of our DM4 attached to an integrin-targeting
antibody developed by Centocor. It is in development by ImmunoGen.
Centocor has certain opt-in rights to this compound.
BIIB015 consists of our DM4 attached to Biogen Idec’s
Cripto-targeting antibody. It is in development by Biogen Idec.
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics using
its expertise in cancer biology, monoclonal antibodies and the
creation and attachment of potent cancer-cell killing agents. The
Company’s TAP technology uses antibodies to deliver one of
ImmunoGen’s cancer-cell killing agents specifically to tumor
targets. In addition to the Company’s product pipeline, compounds
utilizing the TAP technology are in clinical testing through
ImmunoGen’s collaborations with Genentech, sanofi-aventis, Biogen
Idec and Biotest. The most advanced compound, T-DM1, is in
Phase III testing being conducted by Genentech and Roche.
Other ImmunoGen collaborative partners include Bayer HealthCare and
Amgen. More information about ImmunoGen can be found at
www.immunogen.com.
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 2010 fiscal year; its cash and marketable
securities as of June 30, 2010; the advancement of trastuzumab-DM1
(T-DM1) including the occurrence and timing of potential regulatory
submissions; the Company’s and its collaboration partners’ clinical
trial activity and presentation of clinical data; and the Company’s
partnering activities. 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 outcome of ImmunoGen’s research and clinical
development processes; the outcome of ImmunoGen’s collaboration
partners’ research and clinical development processes as well as
the research processes of potential collaboration partners; 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, 2009 and other reports filed with the Securities and
Exchange Commission.
* Genentech is a wholly owned member of the Roche Group.
1 Patients must have had prior treatment with at least two lines
of anti-HER2 therapy in the metastatic setting, and must have
received an anthracycline, a taxane, trastuzumab, lapatinib and
capecitabine in the neoadjuvant, adjuvant, locally advanced or
metastatic setting.
2 Patients must have received prior treatment that included both
a taxane (alone or in combination with another agent) and
trastuzumab in the adjuvant, locally advanced or metastatic
setting.
Revlimid® is a registered trademark of Celgene Corporation.
- Financials Follow -
IMMUNOGEN, INC. SELECTED FINANCIAL INFORMATION (in
thousands, except per share amounts)
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited) December 31, June 30,
2009 2009 ASSETS Cash, cash equivalents and
marketable securities $ 52,433 $ 71,125 Other assets 28,104
29,579 Total assets $ 80,537 $ 100,704
LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities $
11,575 $ 11,128 Long-term portion of deferred revenue and other
long-term liabilities 22,643 22,719 Shareholders' equity
46,319 66,857 Total liabilities and shareholders'
equity $ 80,537 $ 100,704
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (Unaudited) Three
Months Ended Six Months Ended December 31,
December 31, 2009 2008
2009 2008 Revenues: License and
milestone fees $ 827 $ 4,766 $ 2,658 $ 6,989 Clinical materials
reimbursement 998 2,285 1,484 2,981 Research and development
support 1,283 2,283 2,065 5,490
Total revenues 3,108 9,334 6,207
15,460 Expenses: Research and development 12,211 12,888
24,399 24,748 General and administrative 3,886 3,521
7,478 7,199 Total operating expenses
16,097 16,409 31,877 31,947 Loss from
operations (12,989) (7,075) (25,670) (16,487) Other
(loss)/income, net (19) (129) 125 (113)
Loss before taxes (13,008) (7,204) (25,545) (16,600)
(Benefit)/provision for income taxes - (101)
(162) (100) Net loss $ (13,008) $ (7,103) $ (25,383)
$ (16,500)
Net loss per common share, basic and
diluted $ (0.23) $ (0.14) $
(0.44) $ (0.32) Average
common shares outstanding, basic and diluted
57,156 50,822 57,094
50,802
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