Company Expects Up to Eight TAP Compounds in Clinic in the
Coming Months
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 31, 2008--ImmunoGen, Inc.
(Nasdaq: IMGN), a biopharmaceutical company that develops targeted
anticancer therapeutics using its Tumor-Activated Prodrug (TAP)
technology, today announced financial results for the three-month
period ended December 31, 2007 - the second quarter of the Company's
2008 fiscal year.
"We made substantial progress with our internal and partnered
programs in 2007 and expect to build on this strong momentum in 2008
and beyond," commented Mitchel Sayare, Chairman and CEO. "Clinical
data were reported with four compounds in December 2007 alone, and we
expect new findings to be reported in 2008 for most, if not all, of
the compounds now in clinical testing. Additionally, we expect the
number of TAP compounds in the clinic to increase from five today to
as many as eight by this summer - we expect to file an IND for our
third TAP compound, IMGN388, by mid-year, and two of our collaborators
also are finalizing their IND submissions. We look forward to an
exciting year in 2008."
Financial Results
For the three-month period ended December 31, 2007, ImmunoGen
reported a net loss of $6.2 million, or $0.15 per basic and diluted
share, compared to a net loss of $3.0 million, or $0.07 per basic and
diluted share, for the same period last year.
Revenues for the three-month period ended December 31, 2007 were
$9.8 million, compared to $12.1 million for the same quarter last
year. The second quarter fiscal 2008 revenues include $3.7 million of
research and development support fees, compared to $6.6 million for
the same period last year. Research and development support fees
primarily represent funding earned pursuant to ImmunoGen's discovery,
development, and commercialization collaboration with sanofi-aventis
and, to a lesser extent, funding earned under the Company's
development and license agreements with other of its collaborative
partners. The fifth and final contract year with sanofi-aventis began
in September 2007. ImmunoGen expects lower research and development
support fees from sanofi-aventis over the course of this final
contract year versus fiscal 2007 as development activity is
transferred to sanofi-aventis. The second quarter fiscal 2008 revenues
also include $2.7 million of license and milestone fees, compared to
$3.4 million for the same quarter last year. Included in license and
milestone fees for the second quarter of fiscal 2008 was a
$1.0 million milestone related to the initiation of Phase I clinical
testing of SAR3419 by sanofi-aventis. The second quarter fiscal 2008
revenues also include $3.4 million of clinical material reimbursement,
compared to $2.1 million for the same quarter last year. ImmunoGen
manufactures clinical materials on behalf of its collaborators and
earns clinical material reimbursement revenue with the supply of these
materials to the collaborators. The higher clinical material
reimbursement revenue for the second quarter of fiscal 2008 compared
with the same period in the prior year was primarily due to timing of
batch acceptance by our collaborators, as well as to a higher overhead
rate.
Operating expenses for the three-month period ended December 31,
2007 were $16.7 million, compared to $15.9 million in the same period
last year. The operating expenses in the second quarter of fiscal 2008
include research and development expenses of $10.7 million, compared
to $11.8 million for the same quarter last year. The reduction in
research and development expenses for the quarter ended December 31,
2007 versus the prior-year period was driven primarily by a decrease
in antibody costs incurred during the current period and a decrease in
development costs related to the potential production of later-stage
materials incurred at contract manufacturing organizations. We
anticipate costs in both of these areas to increase over the balance
of the fiscal year. The cost of clinical materials reimbursed was $2.4
million in the quarter ended December 31, 2007, compared to
$1.6 million for the same quarter last year. A significant portion of
the DM1/DM4 included in clinical materials reimbursed during the
current and prior periods previously had been categorized as excess
inventory and written down to zero value. Second quarter fiscal 2008
operating expenses also include general and administrative expenses of
$3.5 million, compared to $2.6 million for the same quarter last year.
During the second quarter of fiscal 2008, the Company recognized $0.8
million of expense related to the rental of laboratory and office
space in Waltham, MA, that the Company plans to occupy in late March
2008, classifying such as general and administrative expense.
Other income, consisting primarily of interest income, was $0.7
million in the three-month period ended December 31, 2007, compared to
$0.8 million for the same period last year.
ImmunoGen had approximately $48.7 million in cash and marketable
securities as of December 31, 2007, compared with $59.7 million as of
June 30, 2007, and had no debt outstanding in either period. During
the first six months of fiscal 2008, cash used in operations was $6.9
million, compared to $7.9 million during the same period last year.
Capital expenditures were $5.3 million for the first half of fiscal
2008, compared to $0.9 million for the same period last year. Capital
expenditures for the current period include $2.8 million for
improvement of the Company's capabilities at its manufacturing plant
in Norwood, MA.
Updated Financial Guidance
The Company is updating its guidance for its 2008 fiscal year.
ImmunoGen now expects its net loss to be between $28-31 million,
compared to previous guidance of $30-$33 million, and cash used in
operations to be between $14-17 million, compared with previous
guidance of $30-33 million. The Company expects capital expenditures
to be between $20-21 million, compared with previous guidance of $8-9
million for its 2008 fiscal year. These expectations include a $12
million increase in anticipated capital expenditures related to
leasehold improvements for the facility the Company will be occupying
in Waltham, MA, and a corresponding $12 million decrease in expected
cash used in operations related to funding of these leasehold
improvements by the Waltham landlord.
"This updated guidance reflects an increase in our anticipated
revenue and cash inflow related primarily to additional partner
activity that is now expected to occur during this fiscal year,"
commented Daniel Junius, Executive Vice President and CFO.
"Additionally, our expected expenses have been reduced because of
lower-than-anticipated spending in certain areas and because some
expenses previously expected to occur during our 2008 fiscal year are
now anticipated to occur in fiscal 2009 instead. Also, our expected
fiscal 2008 expenses include nearly $2 million in non-cash expenses
associated with our relocation to Waltham."
ImmunoGen Product Candidates and Expectations for 2008
IMGN242 (huC242-DM4)
Enrollment is ongoing in both the Phase I and Phase II trials
evaluating the TAP compound IMGN242 for the treatment of
relapsed/refractory CanAg-expressing cancer (all cancers and gastric
cancers, respectively).
-- In 2008, the Company expects to report whether the Phase II
study in gastric cancer met the criteria for its expansion.
The Company also expects to report the first clinical findings
from this study.
-- In 2008, the Company expects to report the final results from
the Phase I study.
IMGN901 (huN901-DM1)
Findings from the Phase I trial (Study 003) evaluating the TAP
compound IMGN901 for the treatment of relapsed/refractory
CD56-expressing multiple myeloma were reported in December 2007 at the
annual meeting of the American Society of Hematology (ASH). Among the
findings reported were that two patients who received IMGN901 at one
of the higher doses evaluated to date had an objective response - one
patient had a minimal objective response and remained on IMGN901 for
45 weeks, and a second patient was responding to treatment and had
achieved a minimal objective response at the time of the data cutoff
for the ASH meeting. Both of these patients previously had been
treated with multiple other therapies.
-- In 2008, the Company expects to complete the three ongoing
IMGN901 trials (Studies 001, 002, 003) and to report the final
results.
-- In 2008, the Company expects to outline its development plans
for IMGN901.
-- Assuming the continued development of IMGN901 for multiple
myeloma is warranted, the Company expects to start the next
multiple myeloma trial by the end of 2008.
IMGN388
In December 2007, ImmunoGen licensed the exclusive right to
develop and commercialize a TAP compound to a novel target using an
integrin-targeting antibody developed by Centocor. The target for this
compound occurs on cancer cells, and can also be found on endothelial
cells that are engaged in forming new blood vessels. The process of
angiogenesis is a prerequisite for tumor growth.
-- The Company expects to file an Investigational New Drug (IND)
application for IMGN388 in the second quarter of 2008 and to
initiate clinical testing of the compound during 2008.
Collaboration Product Candidates
Currently, three TAP compounds and one naked antibody compound are
in clinical testing through ImmunoGen's collaborations with other
companies.
-- The Company expects up to two additional TAP compounds to
advance into clinical testing by mid-2008 through its
collaborations with other companies.
Trastuzumab-DM1 (T-DM1)
This TAP compound is in development by Genentech for the treatment
of HER2-positive metastatic breast cancer (MBC). T-DM1 comprises
ImmunoGen's DM1 cell-killing agent linked to Genentech's anti-HER2
antibody, trastuzumab. In July 2007 Genentech initiated a Phase II
study of T-DM1 in HER2-positive MBC patients whose cancer had
progressed on HER2-directed therapy.
Updated Phase I findings were reported at the Annual San Antonio
Breast Cancer Symposium (SABCS) in December 2007. In the study, T-DM1
was administered once every three weeks to patients with HER2-positive
MBC that had progressed on treatment with a chemotherapy regimen that
included Herceptin(R) (trastuzumab). At the SABCS, the study
investigators reported that 12 of the 15 patients treated with T-DM1
at the maximum tolerated dose had either a partial response (PR) or
stable disease (SD). Four of the five PRs reported were ongoing at the
time of the data cutoff for the SABCS (August 31, 2007), and the
longest had been ongoing for over 11 months. Five of the SDs reported
also were ongoing after 130 to 260 days.
In January 2008, Genentech disclosed that Roche has opted in on
the ex-USA development and commercialization of T-DM1.
AVE9633
AVE9633, along with AVE1642 and SAR3419, were initially developed
by ImmunoGen and licensed to sanofi-aventis from the Company's
preclinical pipeline as part of a broader collaboration. AVE9633, a
TAP compound, is in development for the treatment of acute myeloid
leukemia (AML).
Clinical findings were reported at the 2007 ASH annual meeting
from a Phase I trial evaluating AVE9633 when administered on Days 1
and 8 of a 28-day cycle to patients with relapsed/refractory AML.
Evidence of biological activity was reported in seven of the seventeen
patients enrolled in the study. As would be expected in a
dose-escalation trial, the objective responses reported occurred among
the higher doses evaluated.
A Phase I study has been initiated by sanofi-aventis that
evaluates AVE9633 for relapsed/refractory AML when administered on
Days 1, 4, and 7 of a 28-day cycle.
AVE1642
This naked antibody compound is designed to make cancer cells more
susceptible to killing by chemotherapeutic agents by blocking a
pathway used by cancer cells to survive exposure to such agents.
Clinical findings were reported at the 2007 ASH annual meeting from a
Phase I study designed to determine the dose of AVE1642 to be tested
in combination with chemotherapeutic agents. AVE1642 is now undergoing
Phase I clinical evaluation in combination with Velcade(R) for the
treatment of relapsed/refractory multiple myeloma, and in combination
with Taxotere(R) for the treatment of solid tumors.
SAR3419
This TAP compound advanced into Phase I testing for the treatment
of non-Hodgkin's lymphoma in October 2007. It comprises ImmunoGen's
CD19-targeting antibody and DM4 cell-killing agent.
Webcast Information
A conference call is scheduled for today, January 31, 2008, at
4:30 pm ET. The call will include management's discussion of financial
results and provide an update on ImmunoGen. The live call can be
accessed by dialing 913-981-4900 or heard through the Investor
Information section on ImmunoGen's website, www.immunogen.com.
Following the live webcast, a replay of the call will be available on
this website through February 7, 2008.
This press release includes forward-looking statements based on
management's current expectations. The statements include, but are not
limited to, the statements that ImmunoGen: expects to build on strong
momentum in 2008 and beyond; expects new clinical findings to be
reported during 2008 for most, if not all, of the compounds now in the
clinic; expects the number of TAP compounds in the clinic to increase
from five today to as many as eight by this summer; expects to file an
IND application for IMGN388 in the second quarter of 2008; expects to
initiate clinical testing with IMGN388 in the summer of 2008; expects
up to two additional TAP compounds to advance into clinical testing by
mid-2008 through its collaborations with other companies; expects its
net loss to be between $28-31 million and the cash used in operations
to be between $14-17 million; expects capital expenditures to be
between $20-21 million; expects additional partner activity to occur
during this fiscal year; expects to report the final results from the
IMGN242 Phase I study in 2008; expects to report the first findings
from the IMGN242 Phase II study in gastric cancer in 2008 and whether
this study met the criteria for its expansion; expects to complete the
three ongoing IMGN901 trials (Studies 001, 002, 003) in 2008 and to
report the final results; expects to outline in 2008 its development
plans for IMGN901; and, assuming continued development of IMGN901 for
multiple myeloma is warranted, the Company expects to start the next
IMGN901 multiple myeloma trial by the end of 2008. 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; the
difficulties inherent in the development of novel pharmaceuticals,
including uncertainties as to the timing, expense and results of
preclinical studies and clinical trials; ImmunoGen's ability to
financially support its product programs; ImmunoGen's dependence on
collaborative partners; and other factors more fully described in
ImmunoGen's Annual Report on Form 10-K for the fiscal year ended June
30, 2007 and other reports filed with the Securities and Exchange
Commission.
Herceptin(R) is a registered trademark of Genentech, Inc.
Velcade(R) is a registered trademark of Millennium
Pharmaceuticals, Inc.
Taxotere(R) is a registered trademark of sanofi-aventis.
-Financials Follow-
IMMUNOGEN, INC.
----------------------------------------------------------------------
SELECTED FINANCIAL INFORMATION
(in thousands, except per share amounts)
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
December 31, June 30,
2007 2007
------------- ----------
ASSETS
Cash and marketable securities $48,658 $59,700
Other assets 31,115 20,721
------------- ----------
Total assets $79,773 $80,421
============= ==========
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities $13,364 $14,288
Long-term portion of deferred revenue and
other long-term liabilities 13,272 7,732
Shareholders' equity 53,137 58,401
------------- ----------
Total liabilities and shareholders'
equity $79,773 $80,421
============= ==========
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Six Months Ended
Ended
December 31, December 31,
----------------- ------------------
2007 2006 2007 2006
----------------- ------------------
Revenues:
Research and development support $ 3,672 $ 6,593 $ 8,145 $ 12,100
License and milestone fees 2,680 3,428 6,868 4,834
Clinical materials reimbursement 3,399 2,051 6,163 2,908
------- ------- ------- --------
Total revenues 9,751 12,072 21,176 19,842
------- ------- ------- --------
Expenses:
Cost of clinical materials
reimbursed 2,426 1,588 4,155 2,235
Research and development 10,732 11,768 19,837 23,184
General and administrative 3,527 2,566 5,951 5,363
-------- -------- -------- ---------
Total operating expenses 16,685 15,922 29,943 30,782
-------- -------- -------- ---------
Loss from operations (6,934) (3,850) (8,767) (10,940)
Other income, net 727 815 1,540 1,662
-------- -------- -------- ---------
Loss before taxes (6,207) (3,035) (7,227) (9,278)
Income tax expense 5 9 17 20
-------- -------- -------- ---------
Net loss $(6,212) $(3,044) $(7,244) $ (9,298)
======== ======== ======== =========
Net loss per common share, basic
and diluted $ (0.15) $ (0.07) $ (0.17) $ (0.22)
======== ======== ======== =========
Average common shares outstanding,
basic and diluted 42,700 41,571 42,558 41,526
======== ======== ======== =========
CONTACT:
Investors
ImmunoGen, Inc.
Carol Hausner, 617-995-2500
Executive Director, Investor Relations
and Corporate Communications
info@immunogen.com
Media:
KMorrisPR
Kathryn Morris, 845-635-9828
Kathryn@kmorrispr.com
