Phase 3 FORWARD I Trial of Mirvetuximab
Soravtansine Activated in North America and Europe
Data at AACR and SGO Annual Meetings Highlight
Patient Selection Strategy for FORWARD I and Breadth of ADC
Expertise
Mirvetuximab Soravtansine Safety and Efficacy
Data to be Presented at ASCO Annual Meeting
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 quarter ended March 31,
2017.
“We have started 2017 with significant progress towards our
strategic priorities of advancing our portfolio, supporting our
partners, and driving continued innovation in ADCs,” said Mark
Enyedy, ImmunoGen’s president and chief executive officer.
“Following enrollment of our first patient in FORWARD I in January,
we have since expanded the study to include additional centers in
North America and Europe, and expect to activate more than 100
sites in these geographies before the end of the year. We presented
data at the SGO Annual Meeting supporting our patient selection
strategy for FORWARD I and delivered nine presentations at the AACR
Annual Meeting highlighting novel ADCs and enhancements to our
platform technologies. For the remainder of the year, we look
forward to a number of additional milestones, including sharing new
efficacy and safety data for mirvetuximab soravtansine at ASCO and
filing an IND for our CD123-targeting ADC, IMGN632, in the third
quarter.”
Recent Highlights
Proprietary Portfolio
- Treated the first patient in FORWARD I
and expanded the study to more than 40 sites in North America and
Europe;
- Presented expanded Phase 1 data from
the biopsy cohort for mirvetuximab soravtansine at the Society for
Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer
demonstrating that archival tumor tissue can reliably identify
patients with folate receptor alpha (FRα)-positive
platinum-resistant ovarian cancer and supporting the patient
selection strategy for FORWARD I; and
- Delivered nine presentations at the
American Association for Cancer Research (AACR) Annual Meeting
demonstrating improvements to ImmunoGen’s payload and linker
technologies and highlighting data with novel ADCs directed to a
range of tumor targets.
Partner Programs
- Bayer completed enrollment in a
registration-enabling Phase 2 study for anetumab ravtansine in
mesothelioma; and
- Takeda initiated preclinical
development with the first ADC using ImmunoGen’s IGN platform
directed to a solid tumor.
ASCO Presentations
ImmunoGen will report data on mirvetuximab soravtansine in
poster presentations at the 2017 American Society of Clinical
Oncology (ASCO) Annual Meeting on June 3, 2017:
Gynecologic Cancer: General Poster SessionLocation: Hall
ASaturday, June 3, 2017, 1:15 p.m. – 4:45 p.m. CDT
- Title: Mirvetuximab soravtansine
(IMGN853), a folate receptor alpha (FRα)-targeting antibody-drug
conjugate (ADC), in platinum-resistant epithelial ovarian cancer
(EOC) patients (pts): Activity and safety analyses in phase I
pooled expansion cohorts. (Abstract No.: 5547, Poster Board No.:
369)
- Title: Safety findings from FORWARD II:
A phase 1b study evaluating the folate receptor alpha
(FRα)-targeting antibody-drug conjugate (ADC) mirvetuximab
soravtansine (IMGN853) in combination with bevacizumab,
carboplatin, pegylated liposomal doxorubicin (PLD), or
pembrolizumab in patients (pts) with ovarian cancer. (Abstract No.:
5553, Poster Board No.: 375)
- Title: FORWARD I (GOG 3011): A
randomized phase 3 study to evaluate the safety and efficacy of
mirvetuximab soravtansine (IMGN853) versus chemotherapy in adults
with folate receptor alpha (FRα)-positive, platinum-resistant
epithelial ovarian cancer (EOC), primary peritoneal cancer, or
primary fallopian tube cancer. (Abstract No.: TPS5607, Poster Board
No.: 425b)
Additional Upcoming Events
- ImmunoGen expects to present initial
Phase 1 data for IMGN779, a CD33-targeting ADC, for the treatment
of acute myeloid leukemia in mid-2017. These will be the first
clinical data reported with an ADC using ImmunoGen's DNA-alkylating
payload.
- The Company anticipates filing an
investigational new drug (IND) application in the third quarter of
2017 to support clinical testing with IMGN632, a CD123-targeting
ADC integrating a more potent DNA-alkylating payload intended to
treat a range of hematological malignancies.
- ImmunoGen also anticipates advancing
the first development candidate under its collaboration with CytomX
into preclinical development in 2017.
Financial Results
Revenues for the quarter ended March 31, 2017 were $28.5
million, compared to $19.7 million for the quarter ended March 31,
2016. License and milestone fees for the first quarter of 2017
included $6 million in partner milestone payments and $12.7 million
in amortization of a non-cash fee related to the Company’s license
agreement with CytomX, compared with $10 million from partner
milestone payments in the same quarter in 2016. Revenues in the
first quarter of 2017 included $7.6 million in non-cash royalty
revenues, compared with $7.4 million in non-cash royalty revenues
for the same quarter in 2016. Revenues for the first quarter of
2017 also included $1.5 million of research and development
(R&D) support fees and $0.7 million of clinical materials
revenue, compared with $1.1 million and $1.2 million, respectively,
for the same quarter in 2016.
Operating expenses for the first quarter of 2017 were $41.4
million, compared to $47.3 million for the same quarter in 2016.
Operating expenses in the first quarter of 2017 include R&D
expenses of $32.9 million, compared to $36.1 million for the same
quarter in 2016. This change is primarily due to a workforce
reduction resulting from the strategic review in September 2016, as
well as decreased costs associated with manufacturing clinical
materials on behalf of ImmunoGen’s partners. Partially offsetting
these decreases, clinical trial costs increased in the first
quarter of 2017 driven primarily by studies of mirvetuximab
soravtansine. Operating expenses include general and administrative
expenses of $8.1 million in the first quarter of 2017, compared to
$11.2 million in the same quarter in 2016. This decrease is
primarily due to a non-cash stock compensation charge in the first
quarter of 2016 resulting from the CEO transition, as well as
decreased personnel expenses in the first quarter of 2017.
ImmunoGen reported a net loss of $17.3 million, or $0.20 per
basic and diluted share, for the first quarter of 2017 compared to
a net loss of $31.9 million, or $0.37 per basic and diluted share,
for the same quarter last year.
ImmunoGen had approximately $126.6 million in cash and cash
equivalents as of March 31, 2017, compared with $160.0 million as
of December 31, 2016, and had $100.0 million of convertible debt
outstanding in each period. Cash used in operations was $33.0
million for the first quarter of 2017, compared with $26.1 million
for the first quarter of 2016. Capital expenditures were $0.4
million and $3.5 million for the quarters ended March 31, 2017 and
2016, respectively.
Financial Guidance
ImmunoGen’s financial guidance for 2017 remains unchanged from
that issued in February 2017. ImmunoGen expects:
- Revenues between $70 million and $75
million, which includes $28 million of expected upfront and
milestone fees from partners;
- Operating expenses between $175 million
and $180 million; and
- Cash and cash equivalents 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 will hold a conference call today at 8:00 am ET to
discuss these results. To access the live call by phone, dial
719-325-2452; the conference ID is 5957421. 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 May 19, 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.
Kadcyla® is a registered trademark of Genentech, a member of the
Roche Group.
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.
SELECTED FINANCIAL INFORMATION
(in thousands, except per share
amounts)
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited) March 31, December 31,
2017 2016 ASSETS Cash and cash equivalents $
126,568 $ 159,964 Other assets 36,753 38,900
Total assets $ 163,321 $ 198,864 LIABILITIES AND
SHAREHOLDERS' DEFICIT Current liabilities $ 40,367 $ 55,776
Long-term portion of deferred revenue and other long-term
liabilities 290,484 295,938 Shareholders' deficit (167,530)
(152,850) Total liabilities and shareholders' deficit
$ 163,321 $ 198,864
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS (Unaudited) Three Months
Ended March 31, 2017 2016
Revenues: License and milestone fees $ 18,730 $ 10,077
Non-cash royalty revenue 7,613 7,380 Research and development
support 1,665 1,059 Clinical materials revenue 678
1,198 Total revenues 28,686 19,714
Expenses: Research and development 33,070 36,094 General and
administrative 8,119 11,235 Restructuring charge 386
- Total operating expenses 41,575 47,329
Loss from operations (12,889) (27,615) Non-cash
interest expense on liability related to sale of future royalty
& convertible bonds (3,575) (4,972) Interest expense on
convertible bonds (1,125) - Other income, net 249 659
Net loss $ (17,340) $ (31,928)
Net loss per common
share, basic and diluted $ (0.20) $
(0.37) Weighted average common shares
outstanding, basic and diluted 87,160
87,035
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version on businesswire.com: http://www.businesswire.com/news/home/20170505005126/en/
For InvestorsThrust IRMonique Allaire,
617-895-9511monique@thrustir.comorFor MediaFTI Consulting,
Inc.Robert Stanislaro,
212-850-5657robert.stanislaro@fticonsulting.com
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