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
WALTHAM, Mass.--(BUSINESS WIRE)--
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-
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IMMUNOGEN, INC.
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SELECTED FINANCIAL INFORMATION
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(in thousands, except per share amounts)
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CONDENSED CONSOLIDATED BALANCE SHEETS
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(Unaudited)
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September 30,
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June 30,
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2016
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2016
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ASSETS
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Cash and cash equivalents
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$
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196,000
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$
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245,026
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Other assets
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35,348
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34,214
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Total assets
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$
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231,348
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$
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279,240
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LIABILITIES AND SHAREHOLDERS' EQUITY
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Current liabilities
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$
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56,225
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$
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60,439
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Long-term portion of deferred revenue and other long-term liabilities
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297,661
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301,105
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Shareholders' equity
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(122,538
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)
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(82,304
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Total liabilities and shareholders' equity
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$
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231,348
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$
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279,240
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
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(Unaudited)
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Three Months Ended
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September 30,
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2016
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2015
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Revenues:
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License and milestone fees
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$
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76
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$
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6,070
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Non-cash royalty revenue
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6,184
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5,684
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Research and development support
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1,354
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772
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Clinical materials revenue
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46
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2,325
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Total revenues
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7,660
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14,851
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Expenses:
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Research and development
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32,909
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35,132
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General and administrative
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9,459
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8,329
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Restructuring charge
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4,130
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-
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Total operating expenses
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46,498
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43,461
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Loss from operations
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(38,838
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)
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(28,610
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)
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Non-cash interest expense on liability related to sale of future
royalty & convertible bonds
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(5,018
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)
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(5,143
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)
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Interest expense on convertible bonds
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(1,150
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)
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-
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Other income, net
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275
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13
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Net loss
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$
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(44,731
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$
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(33,740
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Net loss per common share, basic and diluted
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$
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(0.51
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)
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$
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(0.39
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)
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Weighted average common shares outstanding, basic and diluted
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87,102
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|
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86,838
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View source version on businesswire.com: http://www.businesswire.com/news/home/20161028005068/en/
For Investors
ImmunoGen, Inc.
Sarah Kiely, 781-895-0600
sarah.kiely@immunogen.com
or
For
Media
ImmunoGen, Inc.
Amy Reilly, 781-895-0138
amy.reilly@immunogen.com
or
FTI
Consulting Inc.
Robert Stanislaro, 212-850-5657
Robert.Stanislaro@fticonsulting.com
Source: ImmunoGen, Inc.
News Provided by Acquire Media