Mirvetuximab Soravtansine Granted Fast Track
Designation by FDA
Encouraging Combination Data Reported from
FORWARD II Expansion Cohort of Mirvetuximab with Avastin®; Initial
Data from Expansion Cohort in Combination with Keytruda® to be
Presented at ESMO
$163 Million Net Proceeds from Public Offering
Extends Cash Runway
Conference Call to be Held at 8:00 a.m. 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 progress in the business and reported
operating results for the quarter ended June 30, 2018.
“During the second quarter, we made significant progress with
mirvetuximab soravtansine, highlighted by FDA Fast Track
designation for the treatment of platinum-resistant ovarian cancer,
and completion of enrollment in our FORWARD I registration study,
which positions us well to report top-line data in the first half
of 2019,” said Mark Enyedy, ImmunoGen’s President and Chief
Executive Officer. “In addition, we expanded the growing body of
clinical data supporting mirvetuximab’s potential to treat a
broader population of women with ovarian cancer in combination with
other agents. Data from our FORWARD II Avastin and carboplatin
cohorts show encouraging clinical activity and tolerability, and
support the triplet combination currently in clinical testing. We
look forward to presenting additional data for mirvetuximab and
Keytruda during 2018 with a poster presentation
at ESMO that will describe the initial findings from this
expansion cohort. Looking at our earlier-stage pipeline of novel
IGN ADCs for hematological malignancies, we expect to report data
from our Phase 1 trials of IMGN779 and IMGN632 in the fourth
quarter. Finally, we strengthened our financial position with an
upsized and oversubscribed public offering that generated $163
million in net proceeds and extends our cash runway at least a year
beyond the Phase 3 readout of FORWARD I.”
CLINICAL PROGRESS
- In June, the Company received U.S. Food
and Drug Administration (FDA) Fast Track designation for
mirvetuximab soravtansine for the treatment of patients with medium
to high folate receptor alpha (FRα)-positive platinum-resistant
ovarian cancer who received at least one, but no more than three
prior systemic treatment regimens, and for whom single-agent
chemotherapy is appropriate as the next line of therapy. This
designation is intended to facilitate the development and expedite
the review of drugs to treat serious and life-threatening
conditions.
- In June, the Company presented
encouraging data from the FORWARD II expansion cohort evaluating
mirvetuximab in combination with bevacizumab (Avastin) at the
American Society of Clinical Oncology (ASCO) Annual Meeting, which
demonstrated anti-tumor activity with durable responses and
favorable tolerability in patients with platinum-resistant ovarian
cancer.
- In May, the Company reported updated
data from the FORWARD II dose-escalation cohort evaluating
mirvetuximab in combination with carboplatin in patients with
recurrent platinum-sensitive ovarian cancer, demonstrating a
favorable safety profile along with an increased response rate and
more durable benefit after longer-term follow up.
- The findings from the carboplatin and
Avastin doublets support the ongoing FORWARD II cohort assessing a
triplet combination of mirvetuximab plus carboplatin and Avastin in
patients with recurrent platinum-sensitive ovarian.
- In April, the Company announced it
completed patient enrollment ahead of schedule in its FORWARD I
Phase 3 trial.
RECENTLY COMPLETED PUBLIC OFFERING
- In June, ImmunoGen completed a public
offering of its common stock raising total net proceeds of
approximately $163 million, after deducting underwriting discounts
and offering expenses.
PARTNER UPDATES
- In May, Takeda enrolled the first
patient in its Phase 1 clinical trial of TAK-164, an ADC
integrating ImmunoGen’s IGN payload, in patients with
gastrointestinal cancers, which triggered a milestone payment to
ImmunoGen.
ANTICIPATED UPCOMING EVENTS
- Report initial findings from the
FORWARD II expansion cohort of mirvetuximab in combination with
pembrolizumab (Keytruda) for 35 patients with medium or high FRα
expression at the European Society for Medical Oncology (ESMO) 2018
Congress in October;
- Report additional data from IMGN779
Phase 1 dose finding study in 4Q 2018;
- Report initial data from IMGN632 Phase
1 dose finding study in 4Q 2018;
- Advance ADAM9 ADC program into
IND-enabling activities before year-end; and
- Report top-line results from Phase 3
FORWARD I trial of mirvetuximab in 1H 2019.
FINANCIAL RESULTSRevenues for the quarter ended June 30,
2018 were $9.3 million, compared with $39 million for the quarter
ended June 30, 2017. License and milestone fees of $1.3 million for
the second quarter of 2018 included $1 million and $0.3 million of
recognized upfront fees previously received from Novartis and
Fusion, respectively, compared to recognition of a $30 million
paid-up license fee received from Sanofi and a $1 million Phase 1
milestone received from CytomX for the same quarter in 2017. The
Company also received a $5 million milestone from Takeda during the
second quarter of 2018 related to the start of Phase 1 testing of
TAK-164, which was recorded as of January 1, 2018 as part of the
transition to the new revenue recognition rules and is therefore
not reflected in revenue in the current period.
Revenues in the second quarter of 2018 included $7.2 million in
non-cash royalty revenues, compared with $6.4 million for the same
quarter in 2017. Revenues for the second quarter of 2018 also
included $0.4 million of research and development (R&D) support
fees and $0.3 million of clinical materials revenue, compared with
$0.9 million and $0.6 million, respectively, for the same quarter
in 2017.
Operating expenses for the second quarter of 2018 were $48
million, compared with $44.2 million for the same quarter in 2017.
The increase was driven by R&D expenses, which increased to
$38.7 million in the second quarter of 2018, compared with $35.3
million for the second quarter of 2017. This increase was primarily
due to higher clinical trial costs driven largely by continued
advancement of the FORWARD I Phase 3 clinical trial and, to a
lesser extent, personnel expenses resulting from expanded headcount
and stock-based compensation. General and administrative expenses
decreased in the second quarter of 2018 to $8.7 million, compared
to $8.8 million in the same quarter of 2017. Operating expenses for
the second quarter of 2018 also included a $0.7 million
restructuring charge due to the workforce reduction related to the
decommissioning of our Norwood facility as previously announced by
the Company.
ImmunoGen reported a net loss of $41.6 million, or $0.31 per
basic and diluted share, for the second quarter of 2018, compared
with a net loss of $8.9 million, or $0.10 per basic and diluted
share, for the same quarter last year.
In June 2018, pursuant to a public offering, the Company sold an
aggregate of 15.8 million shares of its common stock, with net
proceeds to the Company of $162.5 million, after deducting
underwriting discounts and offering expenses.
ImmunoGen had $345.1 million in cash and cash equivalents as of
June 30, 2018, compared with $267.1 million as of December 31,
2017, and had $2.1 million of convertible debt outstanding in each
period. Cash used in operations was $85.3 million for the first six
months of 2018, compared with $8.9 million for the same period in
2017. The prior period benefited from $55 million of fees received
from Sanofi and Debiopharm. Capital expenditures were $2.1 million
and $0.8 million for the six months ended June 30, 2018 and 2017,
respectively.
FINANCIAL GUIDANCEImmunoGen has updated its cash and
operating expenses guidance for 2018. ImmunoGen now expects:
- cash and cash equivalents at December
31, 2018 between $265 million and $270 million; and
- operating expenses between $215 million
and $220 million.
Guidance for revenue remains unchanged:
- revenues between $60 million and $65
million.
ImmunoGen expects that its current cash combined with the
expected cash revenues from partners and collaborators will enable
the Company to fund its operations at least a year beyond the
top-line results from the Phase 3 FORWARD I trial, which are
expected in the first half of 2019.
CONFERENCE CALL INFORMATIONImmunoGen will hold a
conference call today at 8:00 am ET to discuss these results. To
access the live call by phone, dial 719-785-1753; the conference ID
is 2275763. The call may also be accessed through the Investors
section of the Company’s website, www.immunogen.com. Following the
webcast, a replay of the call will be available at the same
location through August 10, 2018.
ABOUT IMMUNOGENImmunoGen is developing the next
generation of antibody-drug conjugates (ADCs) to improve outcomes
for cancer patients. By generating targeted therapies with enhanced
anti-tumor activity and favorable tolerability profiles, we aim to
disrupt the progression of cancer and offer our patients more good
days. We call this our commitment to “target a better now.” Our
lead product candidate, mirvetuximab soravtansine, is in a Phase 3
study for folate receptor alpha (FRα)-positive platinum-resistant
ovarian cancer, and in Phase 1b/2 testing in combination regimens.
Our novel IGN candidates for hematologic malignancies, IMGN779 and
IMGN632, are in Phase 1 studies. Learn more about who we are, what
we do, and how we do it at www.immunogen.com.
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 and operating expenses for the twelve months
ending December 31, 2018; its cash and marketable securities
as of December 31, 2018; 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 year
ended December 31, 2017 and other reports filed with
the Securities and Exchange Commission.
Avastin® and Keytruda® are registered trademarks of their
respective owners.
ImmunoGen, Inc. Reports Financial Results for Quarter and
Six Months Ended June 30, 2018
IMMUNOGEN, INC. SELECTED FINANCIAL
INFORMATION (in thousands, except per share amounts)
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited) June 30, December 31,
2018 2017 ASSETS Cash and cash equivalents $
345,058 $ 267,107 Other assets 36,026 27,569
Total assets $ 381,084 $ 294,676
LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT) Current
portion of deferred revenue $ 1,020 $ 1,405 Other current
liabilities 62,328 54,365 Long-term portion of deferred revenue
80,751 93,752 Other long-term liabilities 147,795 163,049
Shareholders' equity (deficit) 89,190 (17,895
) Total liabilities and shareholders' equity (deficit) $
381,084 $ 294,676
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
Three Months Ended Six Months Ended June 30,
June 30, 2018 2017 2018
2017 Revenues: License and milestone fees $ 1,321 $
31,080 $ 12,861 $ 49,810 Non-cash royalty revenue 7,242 6,439
14,432 14,052 Research and development support 388 902 771 2,380
Clinical materials revenue 336 599
1,038 1,277 Total revenues 9,287
39,020 29,102 67,519 Expenses:
Research and development 38,701 35,319 83,532 68,207 General and
administrative 8,652 8,836 18,647 16,955 Restructuring charge
686 - 2,417 386
Total operating expenses 48,039
44,155 104,596 85,548 Loss from
operations (38,752 ) (5,135 ) (75,494 ) (18,029 ) Non-cash
interest expense on liability related to sale of future royalty
& convertible bonds (2,611 ) (3,501 ) (5,657 ) (7,076 )
Interest expense on convertible bonds (23 ) (1,125 ) (47 ) (2,250 )
Other (loss) income, net (238 ) 894 961
1,143 Net loss $ (41,624 ) $ (8,867 ) $ (80,237 ) $
(26,212 )
Net loss per common share, basic and
diluted $ (0.31 ) $ (0.10
) $ (0.61 ) $ (0.30
) Weighted average common shares
outstanding, diluted 134,384
87,174 132,512
87,167
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version on businesswire.com: https://www.businesswire.com/news/home/20180727005046/en/
INVESTOR RELATIONS CONTACTImmunoGen, Inc.Sarah Kiely,
781-895-0600sarah.kiely@immunogen.comorMEDIA CONTACTCourtney
O’Konek, 781-895-0600courtney.okonek@immunogen.comorFTI
ConsultingRobert Stanislaro,
212-850-5657robert.stanislaro@fticonsulting.com
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