First Patient Enrolled in Phase 3 FORWARD I
Trial of Mirvetuximab Soravtansine
Continued Momentum in 2017 with Data Expected
from Pipeline Programs
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 reviewed recent highlights and reported financial results for
the six-month period and quarter ended December 31, 2016.
“In 2016, we strengthened ImmunoGen operationally and
financially with a focused strategy and disciplined execution,”
said Mark Enyedy, ImmunoGen’s president and chief executive
officer. “Building upon this momentum, we enter 2017 well
positioned to deliver on multiple clinical milestones. In January,
we advanced our lead program to Phase 3, dosing the first patient
in the FORWARD I study of mirvetuximab soravtansine in ovarian
cancer. At the Society of Gynecologic Oncology annual meeting next
month, we will present data from the mirvetuximab biopsy cohort,
followed by initial data in the second quarter from the
mirvetuximab combination regimens being evaluated in our FORWARD II
study. We are also excited about the potential of our
DNA-alkylating ADCs and expect to report the first data from the
Phase 1 study of IMGN779 for acute myeloid leukemia in mid-2017 and
to file an IND for IMGN632 in the third quarter.”
Recent highlights include:
Proprietary Portfolio
- First patient dosed in the Phase 3
FORWARD I registration trial of mirvetuximab soravtansine in
platinum-resistant ovarian cancer (January 2017);
- Publication of results of the
mirvetuximab soravtansine Phase 1 expansion cohort in the Journal
of Clinical Oncology (December 2016);
- Oral and poster presentations
highlighting preclinical data for IMGN632 at the American Society
of Hematology (ASH) Annual Meeting (December 2016), demonstrating
exceptional activity in acute myeloid leukemia (AML) models,
including those resistant to standard of care therapies, as well as
reduced toxicity to human marrow progenitor cells, compared to a
DNA-crosslinking payload while maintaining similar potency;
- Presentation of preclinical data at
Society for Immunotherapy of Cancer’s (SITC) 2016 conference
demonstrating the potential for enhanced activity when combining
mirvetuximab soravtansine with immune checkpoint inhibition
(November 2016).
Partner Programs
- Sanofi advancing isatuximab
(SAR650984), a CD38-targeting antibody, in combination with pom-dex
to a Phase 3 clinical trial in multiple myeloma (Q4 2016); and
- Novartis dosing the first patient with
HKT288, a CDH6-targeting ADC, in a Phase 1 clinical trial in
ovarian cancer and renal cell carcinoma (December 2016).
Upcoming anticipated events include:
- Activation of more than 100 sites in
North America and Western Europe to enable the rapid enrollment of
patients to the mirvetuximab soravtansine Phase 3 FORWARD I
trial;
- Presentation of:
- Expanded Phase 1 data from the biopsy
cohort for mirvetuximab soravtansine at the Society of Gynecologic
Oncology (SGO) annual meeting (March 2017);
- Nine posters highlighting ImmunoGen’s
technology and innovation in ADCs at the American Association for
Cancer Research (AACR) annual meeting (April 2017);
- Initial data from the Company’s Phase
1b/2 FORWARD II trial evaluating mirvetuximab soravtansine in
combination with Avastin®, carboplatin, Doxil® or Keytruda® (Q2
2017);
- Pooled data from over 100 ovarian
cancer patients treated in multiple mirvetuximab soravtansine Phase
1 cohorts and data from the Phase 1 steroid eye drop expansion
cohort (Q2 2017);
- Initial Phase 1 data for IMGN779, a
CD33-targeting ADC, for the treatment of AML (mid-2017), which will
be the first clinical data reported with an ADC using ImmunoGen’s
DNA-alkylating payload;
- Filing of an IND to initiate clinical
testing with IMGN632, a CD123-targeting ADC integrating a more
potent DNA-alkylating payload (Q3 2017).
Financial Results
As previously disclosed, effective January 1, 2017, ImmunoGen
transitioned to a fiscal year ending December 31. Revenues for the
six month transition period ended December 31, 2016 were $21.5
million, compared to $32.9 million for the six months ended
December 31, 2015. License and milestone fees for the current
period include a $5 million partner milestone payment achieved
compared to $8.6 million of amortization of upfront fees received
from Takeda and $8 million from partner milestone payments in
the prior period. Revenues in the current period include $12.9
million of non-cash royalty revenues, compared with $12.0 million
in non-cash royalty revenues and $0.2 million in cash royalty
revenues for the prior period. Revenues for the current period also
include $2.8 million of research and development support fees and
$0.7 million of clinical materials revenue, compared with $1.6
million and $2.3 million, respectively, in the prior period.
Operating expenses for the six month transition period ended
December 31, 2016 were $89.0 million, compared to $89.7 million for
the six months ended December 31, 2015. Operating expenses in the
current period include research and development expenses of
$66.6 million, compared to $73.3 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 to
support pivotal development for mirvetuximab soravtansine,
decreased costs associated with manufacturing clinical materials on
behalf of our partners, and decreased cytotoxic and antibody costs
due to timing of supply requirements. Operating expenses include
general and administrative expenses of $18.0 million in the
current period, compared to $16.4 million in the prior period.
This increase is primarily due to $2.4 million of one-time
third-party service fees incurred relating to the Company’s
strategic review and resulting restructuring activities, partially
offset by lower salaries and related expenses and lower
administrative expenses. Operating expenses in the current period
correspondingly include a $4.4 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.
ImmunoGen reported a net loss of $78.9 million, or $0.91 per
basic and diluted share, for the Company’s six month fiscal year
transition period ended December 31, 2016 compared to a net loss of
$67.0 million, or $0.77 per basic and diluted share, for the
same period last year.
ImmunoGen had approximately $160.0 million in cash and cash
equivalents as of December 31, 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 $83.7 million for the six months ended December 31,
2016, compared with $65.5 million for the six months ended
December 31, 2015. Capital expenditures were $1.4 million and $5.1
million for the six months ended December 31, 2016 and 2015,
respectively.
Financial Guidance
For 2017, ImmunoGen expects:
- revenues between $70 million and
$75 million, which includes $28 million of expected upfront and
milestone fees from our partners;
- operating expenses between
$175 million and $180 million; and
- cash and marketable securities at
December 31, 2017 between $35 million and
$40 million.
ImmunoGen expects that its current cash plus expected cash
revenues from partners and collaborators will enable the Company to
fund operations into the second quarter of 2018.
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
719-457-2627; the conference ID is 4132697. The call may also 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 March 3, 2017.
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 in 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 twelve months ending
December 31, 2017; its cash and marketable securities as of
December 31, 2017; 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. Reports Financial Results for Quarter and
Six Months Ended December 31, 2016
IMMUNOGEN, INC. SELECTED FINANCIAL INFORMATION
(in thousands, except per share amounts) CONDENSED
CONSOLIDATED BALANCE SHEETS (Unaudited)
December 31, June 30, 2016 2016 ASSETS
Cash and cash equivalents $ 159,964 $ 245,026 Other assets
38,900 34,214 Total assets $ 198,864 $ 279,240
LIABILITIES AND SHAREHOLDERS' DEFICIT Current
liabilities $ 55,776 $ 60,439 Long-term portion of deferred revenue
and other long-term liabilities 295,938 301,105 Shareholders'
deficit (152,850) (82,304) Total liabilities
and shareholders' deficit $ 198,864 $ 279,240
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited) Three Months Ended Six Months
Ended December 31, December 31, 2016
2015 2016
2015 Revenues: License and milestone fees $
5,076 $ 10,692 $ 5,152 $ 16,762 Royalty revenue - 195 - 195
Non-cash royalty revenue 6,710 6,291 12,894 11,975 Research and
development support 1,427 848 2,781 1,620 Clinical materials
revenue 633 3 679 2,328 Total revenues
13,846 18,029 21,506 32,880 Expenses: Research and
development 33,657 38,199 66,566 73,331 General and administrative
8,536 8,054 17,995 16,383 Restructuring charge 301 -
4,431 - Total operating expenses 42,494 46,253
88,992 89,714 Loss from operations (28,648) (28,224)
(67,486) (56,834) Non-cash interest expense on liability
related to sale of future royalty & convertible bonds (3,647)
(5,059) (8,665) (10,202) Interest expense on convertible bonds
(1,099) - (2,249) - Other (loss) income, net (758) 56
(483) 69 Net loss $ (34,152) $ (33,227) $ (78,883) $
(66,967)
Net loss per common share, basic and diluted
$ (0.39) $ (0.38) $
(0.91) $ (0.77) Weighted
average common shares outstanding, diluted 87,102
86,970 87,102 86,904
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version on businesswire.com: http://www.businesswire.com/news/home/20170217005091/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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