Initial Data from FORWARD II Expansion Cohort
of Mirvetuximab Soravtansine with KEYTRUDA® Reported at ESMO
Phase 1 Data for IMGN779 and IMGN632 to be
Presented in Oral Sessions at ASH
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 September 30, 2018.
“With the completion of enrollment in FORWARD I, we have
initiated the activities required to support a BLA filing and
launch mirvetuximab soravtansine in ovarian cancer. Over the last
three months, we have completed the product validation runs for
drug substance, put in place operational metrics and resources to
ensure timely assessment of the primary endpoint for the study, and
moved ahead with pre-launch commercial planning,” said Mark Enyedy,
ImmunoGen’s President and Chief Executive Officer. “In parallel, we
continued to execute across the remainder of the business,
including presentation of initial data from the FORWARD II KEYTRUDA
combination at ESMO, accelerating accrual in the FORWARD II triplet
cohort, and advancing our next ADC into preclinical development in
collaboration with MacroGenics. Looking ahead to the fourth quarter
and the coming year, with a strong cash runway, we are
well-positioned to deliver on our strategic priorities and look
forward to oral presentations for our novel IGN assets, IMGN779 and
IMGN632, at ASH in December and to announcing top-line results from
FORWARD I during the first half of 2019.”
PIPELINE PROGRESS AND PARTNER-RELATED UPDATES
- Favorable tolerability and encouraging
anti-tumor activity data from the FORWARD II expansion cohort of
mirvetuximab soravtansine in combination with Merck’s anti-PD-1
therapy, KEYTRUDA® (pembrolizumab), in patients with
platinum-resistant ovarian cancer were presented at the 2018
European Society for Medical Oncology (ESMO) Congress in October.
The goal of the combination is to prolong clinical benefit of the
ADC in later-line patients through concomitant activation of the
immune system.
- The Food and Drug Administration (FDA)
has granted orphan-drug designation to IMGN632 for the treatment of
acute myeloid leukemia (AML).
- ImmunoGen and MacroGenics advanced the
IMGC936 (ADAM9-targeting ADC) program into IND-enabling activities.
ADAM9-positive tumor types include non-small cell lung,
triple-negative breast, gastric, and pancreatic cancers.
- ImmunoGen presented preclinical data
related to an epithelial cell adhesion molecule (EpCAM)-targeting
Probody drug conjugate (PDC) at the European Antibody Congress in
October. The EpCAM-targeting PDC integrates the PROBODY™ technology
developed by CytomX, which enables the selection of targets
previously thought to be incompatible with ADC development due to
high normal tissue expression.
- Roche announced in October that the
Phase 3 KATHERINE study met its primary endpoint showing that
KADCYLA® (trastuzumab emtansine) as a single agent significantly
reduced the risk of disease recurrence or death (invasive
disease-free survival, iDFS) compared to HERCEPTIN® (trastuzumab)
as an adjuvant treatment in people with HER2-positive early breast
cancer who have residual disease present following neoadjuvant
treatment.
ANTICIPATED UPCOMING EVENTS
- Oral presentation of data from IMGN779
Phase 1 dose finding study at the 2018 American Society of
Hematology (ASH) Annual Meeting;
- Oral presentation of initial data from
IMGN632 Phase 1 dose finding study at the 2018 ASH Annual Meeting
and preclinical poster sessions related to IMGN632;
- Complete enrollment in the FORWARD II
cohort assessing a triplet combination of mirvetuximab plus
carboplatin and AVASTIN® (bevacizumab) in patients with recurrent
platinum-sensitive ovarian before the end of 2018, and report
initial data in mid-2019;
- Initiate a new expansion cohort in the
FORWARD II study to evaluate mirvetuximab plus AVASTIN in patients
with recurrent ovarian cancer in 1Q 2019; and
- Report top-line results from Phase 3
FORWARD I trial of mirvetuximab soravtansine in 1H 2019.
FINANCIAL RESULTSRevenues for the quarter ended September
30, 2018 were $10.9 million, compared with $8.5 million for the
quarter ended September 30, 2017. License and milestone fees of
$0.7 million for the third quarter of 2018 included recognition of
a $0.5 million milestone pursuant to a license agreement with
Fusion Pharmaceuticals. Revenues in the third quarter of 2018
included $8.4 million in non-cash royalty revenues, compared with
$6.5 million for the same quarter in 2017. Revenues for the third
quarter of 2018 also included $0.4 million of research and
development (R&D) support fees and $1.4 million of clinical
materials revenue, compared with $0.7 million and $1.2 million,
respectively, for the same quarter in 2017.
Operating expenses for the third quarter of 2018 were $56.5
million, compared with $39.6 million for the same quarter in 2017.
The increase was driven by R&D expenses, which were $47.2
million in the third quarter of 2018, compared with $31.7 million
for the third quarter of 2017. This increase was primarily due to
higher antibody and cytotoxic manufacturing costs in support of
commercial validation runs for mirvetuximab soravtansine, along
with higher clinical trial costs related to the FORWARD II
combination assessments and, to a lesser extent, expenses resulting
from stock-based compensation. General and administrative expenses
in the third quarter of 2018 were $8.3 million, compared to $7.9
million in the same quarter of 2017. Operating expenses for the
third quarter of 2018 also included a $0.9 million restructuring
charge due to the workforce reduction related to the previously
announced decommissioning of the Company’s Norwood facility.
ImmunoGen reported a net loss of $46.8 million, or $0.32 per
basic and diluted share, for the third quarter of 2018, compared
with a net loss of $56.7 million, or $0.61 per basic and diluted
share, for the same quarter last year. Weighted average shares
outstanding increased to 147.2 million from 93 million in those
quarters.
ImmunoGen had $303.2 million in cash and cash equivalents as of
September 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 $125.1 million for the first
nine months of 2018, compared with cash provided from operations of
$37.1 million for the same period in 2017. The prior period
benefited from a $30 million paid-up license fee received from
Sanofi, a $75 million upfront payment received from Jazz
Pharmaceuticals, and a $25 million upfront payment received from
Debiopharm. Capital expenditures were $4.2 million and $0.8 million
for the nine months ended September 30, 2018 and 2017,
respectively.
FINANCIAL GUIDANCEImmunoGen has updated its cash and
revenue guidance for 2018. ImmunoGen now expects:
- cash and cash equivalents at December
31, 2018 to be between $250 million and $255 million;
and
- revenues between $50 million and $55
million.
Guidance for operating expenses remains unchanged:
- operating expenses between $215 and
$220 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 323-794-2423; the conference ID
is 8582527. 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 November 16, 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.
KEYTRUDA® is a registered trademark of Merck Sharp &
Dohme Corp., a subsidiary of Merck & Co.,
Inc., Kenilworth, NJ, USA. KADCYLA®, HERCEPTIN®, and AVASTIN®
are registered trademarks of Genentech, a member of the Roche
Group. PROBODY™ is a trademark of CytomX Therapeutics, Inc.
FORWARD-LOOKING STATEMENTSThis 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.
ImmunoGen, Inc. Reports Financial Results for Quarter and
Nine Months Ended September 30, 2018
IMMUNOGEN, INC.
SELECTED FINANCIAL INFORMATION (in thousands,
except per share amounts) CONDENSED CONSOLIDATED
BALANCE SHEETS (Unaudited) September 30,
December 31, 2018 2017 ASSETS Cash and
cash equivalents $ 303,205 $ 267,107 Other assets 36,659
27,569 Total assets $ 339,864 $
294,676 LIABILITIES AND SHAREHOLDERS' EQUITY
(DEFICIT) Current portion of deferred revenue $ 1,713 $
1,405 Other current liabilities 68,657 54,365 Long-term portion of
deferred revenue 80,592 93,752 Other long-term liabilities 142,014
163,049 Shareholders' equity (deficit) 46,888
(17,895 ) Total liabilities and shareholders' equity
(deficit) $ 339,864 $ 294,676
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited) Three Months Ended Nine Months
Ended September 30, September 30, 2018
2017 2018
2017 Revenues: License and milestone fees $ 672 $ 79
$ 13,533 $ 49,889 Non-cash royalty revenue 8,441 6,503 22,873
20,555 Research and development support 388 650 1,159 3,030
Clinical materials revenue 1,427 1,248
2,465 2,525 Total revenues
10,928 8,480 40,030
75,999 Expenses: Research and development
47,243 31,689 130,775 99,896 General and administrative 8,347 7,908
26,994 24,863 Restructuring charge 870 -
3,287 386 Total operating
expenses 56,460 39,597 161,056
125,145 Loss from operations (45,532 )
(31,117 ) (121,026 ) (49,146 ) Non-cash debt conversion
expense - (22,191 ) - (22,191 ) Non-cash interest expense on
liability related to sale of future royalty & convertible bonds
(2,546 ) (3,385 ) (8,203 ) (10,461 ) Interest expense on
convertible bonds (23 ) (762 ) (70 ) (3,012 ) Other income (loss),
net 1,294 773 2,255
1,916 Net loss $ (46,807 ) $ (56,682 ) $
(127,044 ) $ (82,894 )
Net loss per common share, basic
and diluted $ (0.32 ) $
(0.61 ) $ (0.92 ) $
(0.93 ) Weighted average common
shares outstanding, diluted 147,220
93,001 137,472
89,133
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version on businesswire.com: https://www.businesswire.com/news/home/20181102005091/en/
INVESTOR RELATIONS CONTACTImmunoGen, Inc.Sarah Kiely,
781-895-0600sarah.kiely@immunogen.comorMEDIA CONTACTCourtney
O’Konek, 781-895-0600courtney.okonek@immunogen.comorTHRUST
Strategic CommunicationsChelcie Lister,
910-777-3049chelcie@thrustsc.comorFTI ConsultingRobert Stanislaro,
212-850-5657robert.stanislaro@fticonsulting.com
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