Phase 3 FORWARD I Trial of Mirvetuximab
Soravtansine On Track to Begin before Year End
FORWARD II Trial Assessing Mirvetuximab
Soravtansine Combinations with Avastin®, Carboplatin, Doxil®, and
Keytruda® Ongoing
Strategic Review Completed to Strengthen
Underlying Business and Drive Long-term Growth
Conference Call to be Held at 8:00am ET
Today
ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today reported financial results and reviewed business highlights
for the three-month period ended September 30, 2016.
“During the last quarter, we strengthened our business and
better positioned ImmunoGen for long-term growth,” said Mark
Enyedy, president and chief executive officer of ImmunoGen. “We
prioritized our portfolio to focus on initiating Phase 3
development of and generating combination data with mirvetuximab
soravtansine, as well as accelerating our earlier-stage IGN
programs, IMGN779 and IMGN632. We look forward to starting our
registration-enabling trial for mirvetuximab soravtansine before
the end of the year and to an oral presentation for IMGN632 at ASH.
Together with our strong cash position, the steps we have
undertaken as part of our strategic review will enable us to fund
our operations through the FORWARD I interim analysis and into
mid-2018.”
Updates and anticipated events with the Company’s programs
include:
Mirvetuximab soravtansine
- The Phase 3 FORWARD I trial of
mirvetuximab soravtansine in platinum-resistant ovarian cancer is
on track to enroll the first patient before the end of the
year.
- Combination regimens with mirvetuximab
soravtansine in ovarian cancer are being evaluated in the Phase
1b/2 FORWARD II trial at sites in the U.S., Canada, and Europe.
Dosing was initiated with Keytruda® and continued with Doxil® in
patients with platinum-resistant disease and, separately, with
carboplatin in platinum-sensitive patients. Following successful
completion of dose escalation, a Phase 2 expansion cohort in
combination with Avastin® is ongoing. ImmunoGen expects to report
initial data from FORWARD II in 2017.
IMGN779 and IMGN632
- Preclinical data from the IMGN779 and
IMGN632 programs will be presented at the ASH Annual Meeting in
December, which will include an oral presentation for IMGN632.
- A Phase 1 trial of CD33-targeting
IMGN779 in acute myeloid leukemia (AML) is ongoing with the first
clinical data expected to be reported in 2017. IMGN779 is the first
ADC with ImmunoGen’s DNA-acting IGN technology to enter clinical
testing.
- ImmunoGen intends to submit an IND
application for and to initiate clinical testing of IMGN632 in
2017. IMGN632 is a CD123-targeting IGN ADC for the treatment of
hematological malignancies.
Financial Results
For the Company’s quarter ended September 30, 2016, ImmunoGen
reported a net loss of $44.7 million, or $0.51 per basic and
diluted share, compared to a net loss of $33.7 million, or
$0.39 per basic and diluted share, for the same quarter last
year.
Revenues for the quarter ended September 30, 2016 were $7.7
million, compared to $14.9 million for the quarter ended
September 30, 2015. License and milestone fees for the prior period
include $6 million from partner milestone payments compared to
no milestone payments received in the current period. Revenues in
the current period include $6.2 million of non-cash royalty
revenues, compared with $5.7 million in non-cash royalty revenues
for the prior period. Revenues for current period also include $1.4
million of research and development support fees and $46,000 of
clinical materials revenue, compared with $0.8 million and $2.3
million, respectively, in the prior period.
Operating expenses for the quarter ended September 30, 2016 were
$46.5 million, compared to $43.5 million for the quarter ended
September 30, 2015. Operating expenses in the current period
include research and development expenses of $32.9 million,
compared to $35.1 million in the prior period. This change is
primarily due to a decrease in third-party costs resulting from
activities performed in the prior period related to developing
assays to support pivotal development for mirvetuximab soravtansine
and decreased costs associated with manufacturing clinical
materials on behalf of our partners, partially offset by increased
personnel expenses driven principally by hiring over the prior
fiscal year. Operating expenses include general and administrative
expenses of $9.5 million in the current period, compared to
$8.3 million in the prior period. This increase is primarily
due to increased third-party service fees relating to the Company’s
strategic review announced on September 29, 2016. Operating
expenses in the current period correspondingly include a $4.1
million restructuring charge, which includes costs related to a 17%
workforce reduction and a $1 million impairment loss on leasehold
improvements related to leased office space that the Company will
not occupy and will seek to sublease. An additional $0.3 million
charge related to the restructuring is anticipated to be recorded
in the quarter ending December 31, 2016 when the Company will begin
to realize overall cost reductions related to the
restructuring.
ImmunoGen had approximately $196.0 million in cash and cash
equivalents as of September 30, 2016, compared with $245.0 million
as of June 30, 2016, and had $100.0 million of
convertible debt outstanding in each period. Cash used in
operations was $48.6 million for the quarter ended September 30,
2016, compared with $31.4 million for the quarter ended
September 20, 2015. Capital expenditures were $0.4 million and $3.4
million for the quarter ended September 30, 2016 and 2015,
respectively.
Financial Guidance
As previously disclosed, ImmunoGen is transitioning to a fiscal
year ending December 31, effective January 1, 2017. ImmunoGen has
updated its financial guidance for the six months ending December
31, 2016. Expected revenues are now projected to be between
$25 million and $30 million, compared with previous guidance
of between $40 million and $45 million; operating expenses are now
projected to be between $90 million and $95 million, compared with
previous guidance of $95 million and $100 million; the
Company’s guidance for its net loss is now expected to be between
$70 million and $75 million, compared to its previous estimate of
$55 million and $60 million.
ImmunoGen now projects cash and marketable securities at
December 31, 2016 to be between $165 million and $170 million,
compared to previous guidance of $170 million and
$175 million. The Company’s guidance for cash used in
operations is now projected to be between $70 million and $75
million, which had previously been between $65 million and $70
million. The Company’s guidance for capital expenditures remains
unchanged, which is between $2 million and $5 million.
Conference Call Information
ImmunoGen is holding a conference call today at 8:00 am ET to
discuss these results. To access the live call by phone, dial
913-312-0710; the conference ID is 4316729. The call also may be
accessed through the Investors section of the Company's website,
www.immunogen.com. Following the live webcast, a replay of the call
will be available at the same location through November 11,
2016.
About ImmunoGen, Inc.
ImmunoGen is a clinical-stage biotechnology company that
develops targeted cancer therapeutics using its proprietary ADC
technology. ImmunoGen's lead product candidate, mirvetuximab
soravtansine, is being advanced to a Phase 3 trial for FRα-positive
platinum-resistant ovarian cancer, and is in Phase 1b/2
testing in combination regimens for earlier-stage disease.
ImmunoGen's ADC technology is used in Roche's marketed product,
Kadcyla®, in three other clinical-stage ImmunoGen product
candidates, and in programs in development by partners Amgen,
Bayer, Biotest, CytomX, Lilly, Novartis, Sanofi and Takeda. More
information about the Company can be found at
www.immunogen.com.
Avastin®, Doxil®, Keytruda® and Kadcyla® are registered
trademarks of their respective owners.
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 revenues, operating expenses, net loss, cash used in
operations and capital expenditures for the six months ending
December 31, 2016; its cash and marketable securities as of
December 31, 2016; 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, 2016 and other reports filed with the Securities and
Exchange Commission.
-Financials Follow-
IMMUNOGEN, INC.
SELECTED FINANCIAL INFORMATION (in thousands,
except per share amounts) CONDENSED CONSOLIDATED
BALANCE SHEETS (Unaudited) September 30,
June 30, 2016 2016 ASSETS
Cash and cash equivalents $ 196,000 $ 245,026 Other assets
35,348 34,214 Total assets $ 231,348
$ 279,240 LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities $ 56,225 $ 60,439 Long-term portion of
deferred revenue and other long-term liabilities 297,661 301,105
Shareholders' equity (122,538 ) (82,304 )
Total liabilities and shareholders' equity $ 231,348 $
279,240
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS (Unaudited) Three Months
Ended September 30, 2016
2015 Revenues: License and milestone fees $ 76 $
6,070 Non-cash royalty revenue 6,184 5,684 Research and development
support 1,354 772 Clinical materials revenue 46
2,325 Total revenues 7,660
14,851 Expenses: Research and development
32,909 35,132 General and administrative 9,459 8,329 Restructuring
charge 4,130 - Total operating
expenses 46,498 43,461 Loss from
operations (38,838 ) (28,610 ) Non-cash interest expense on
liability related to sale of future royalty & convertible bonds
(5,018 ) (5,143 ) Interest expense on convertible bonds (1,150 ) -
Other income, net 275 13 Net
loss $ (44,731 ) $ (33,740 )
Net loss per common share,
basic and diluted $ (0.51 ) $
(0.39 ) Weighted average common
shares outstanding, basic and diluted 87,102
86,838
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version on businesswire.com: http://www.businesswire.com/news/home/20161028005068/en/
For InvestorsImmunoGen, Inc.Sarah Kiely,
781-895-0600sarah.kiely@immunogen.comorFor MediaImmunoGen, Inc.Amy
Reilly, 781-895-0138amy.reilly@immunogen.comorFTI Consulting
Inc.Robert Stanislaro,
212-850-5657Robert.Stanislaro@fticonsulting.com
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