Encouraging Efficacy Signal Observed in Pre-Specified Subset of
Patients in Phase 3 FORWARD I Study; Company to Meet with
Regulators this Quarter to Discuss Potential Path Forward for
Mirvetuximab Soravtansine Monotherapy
FORWARD II Trial with Mirvetuximab Combinations Continues to
Enroll, with Mature Data from Avastin® Expansion Cohort to be
Presented at ASCO
Operational Review Underway with Goal of Extending Cash
Position
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
financial results for the quarter ended March 31, 2019.
“Following the readout of the top-line results from FORWARD I,
we have undertaken a comprehensive analysis of the data and see a
consistent efficacy signal across a range of parameters in the
pre-specified subset of ovarian cancer patients with high folate
receptor alpha (FRα) expression. Specifically, in comparison to
chemotherapy, we have observed higher response rates, more durable
responses, and longer progression-free and overall survival in
patients with high FRα expression treated with mirvetuximab,” said
Mark Enyedy, ImmunoGen’s President and Chief Executive Officer.
“With the benefit of this analysis and input from our clinical and
regulatory advisors, we will be meeting with the FDA this quarter
to discuss a potential path to registration for mirvetuximab as a
monotherapy.”
Enyedy continued, “In parallel, our FORWARD II combination trial
continues to enroll patients and we look forward to presenting
mature data for mirvetuximab in combination with Avastin in
platinum-resistant ovarian cancer patients at ASCO. In addition, we
ended the quarter with $270 million on the balance sheet and are
conducting an operational review to enable us to extend our cash
runway and execute against our goal of delivering more good days to
people with cancer.”
RECENT PROGRESS
Mirvetuximab Soravtansine
- Top-line results announced from the
Phase 3 FORWARD I study of mirvetuximab soravtansine in
FRα-positive, platinum-resistant ovarian cancer; data from the
pre-specified subset of patients with high FRα expression suggest a
favorable benefit-risk profile in this population.
- Enrollment initiated for FORWARD II
Avastin® (bevacizumab) cohort in ovarian cancer patients for whom a
non-platinum-based regimen would be an appropriate next therapy;
this “platinum agnostic” population will include patients
progressing after PARP inhibitor maintenance therapy, who represent
an increasing share of the market.
IGN Programs, Early-Stage Pipeline, and Research
- Enrollment continues in expansion
cohorts of a Phase 1 study of IMGN632 in patients with relapsed or
refractory adult acute myeloid leukemia (AML) and blastic
plasmacytoid dendritic cell neoplasm (BPDCN); study expanded to
Europe.
- Enrollment nearing completion for Phase
1 study of IMGN779 in AML patients.
- IND-enabling activities on track for
IMGC936, a novel ADAM9-targeting ADC being developed in
collaboration with MacroGenics.
- Eleven posters presented at the
American Association of Cancer Research (AACR) Annual Meeting in
March demonstrating continued innovation from the Company’s
research platform.
Operational Updates
- Sale of residual rights to receive
royalty payments on commercial sales of Kadcyla® (ado-trastuzumab
emtansine) to the Ontario Municipal Employees Retirement System
(OMERS), the defined benefit pension plan for municipal employees
in the Province of Ontario, Canada, completed for $65 million.
- Operational review of the business
underway with the objective of extending the Company’s cash
runway.
ANTICIPATED UPCOMING EVENTS
- Meet with the U.S. Food and Drug
Administration (FDA) in Q2 to discuss a potential path to
registration for mirvetuximab soravtansine as a monotherapy for the
treatment of platinum-resistant ovarian cancer patients with high
FRα expression; the Company also plans to engage with the European
Medicines Agency (EMA) around conditional marketing
authorization;
- Present mature data from the FORWARD II
expansion cohort evaluating mirvetuximab in combination with
Avastin in patients with platinum-resistant ovarian cancer at the
American Society of Clinical Oncology (ASCO) Annual Meeting;
additional data from an investigator-sponsored study evaluating
mirvetuximab in combination with gemcitabine will also be
presented;
- Present full FORWARD I data and initial
FORWARD II triplet data at a medical meeting later this year;
- Present updated IMGN632 data with
additional AML and BPDCN patients, and establish the recommended
Phase 2 dose and schedule; initiate IMGN632 combination
studies;
- Establish IMGN779 recommended Phase 2
dose and schedule; and
- Submit an IND for IMGC936 before the
end of 2019.
FINANCIAL RESULTSRevenues for the quarter ended March 31,
2019 were $8.6 million, compared with $19.8 million for the quarter
ended March 31, 2018. Revenues in the first quarter of 2019
included $8.5 million in non-cash royalty revenues, compared with
$7.2 million for the first quarter of 2018. Revenues for the prior
year period also included $11.5 million of recognized upfront
license and milestone fees previously received from partners, $0.4
million of research and development (R&D) support fees, and
$0.7 million of clinical materials revenue, compared with $0.1
million of similar fees earned in the current period.
Operating expenses for the first quarter of 2019 were $50.2
million, compared with $56.6 million for the same quarter in 2018.
The decrease was driven by R&D expenses, which were $38.9
million in the first quarter of 2019, compared with $44.8 million
for the first quarter of 2018. This decrease was primarily due to
lower clinical trial costs in the current period, driven by patient
enrollment in the FORWARD I Phase 3 clinical trial during the prior
year period. General and administrative expenses in the first
quarter of 2019 were $10.8 million, compared to $10.0 million in
the first quarter of 2018, primarily due to increased personnel
costs driven by greater stock-based compensation and severance
expense, partially offset by decreased third-party service fees.
Operating expenses for the first quarter of 2019 also included a
$0.6 million restructuring charge related to a loss recorded on
leased office space, compared to a $1.7 million charge recorded in
the first quarter of 2018 related to the decommissioning of the
Company’s Norwood facility.
ImmunoGen reported a net loss of $43.8 million, or $0.30 per
basic and diluted share, for the first quarter of 2019, compared
with a net loss of $38.6 million, or $0.30 per basic and diluted
share, for the same quarter last year. Weighted average shares
outstanding increased to 147.8 million from 130.6 million in those
quarters.
ImmunoGen had $270.4 million in cash and cash equivalents as of
March 31, 2019, compared with $262.3 million as of December 31,
2018, and had $2.1 million of convertible debt outstanding in each
period. Cash provided by operations was $10.2 million for the first
quarter of 2019, compared with cash used in operations of $(50.0)
million for the first quarter of 2018. The current period benefited
from $65.2 million of net proceeds generated from the sale of the
Company’s residual rights to Kadcyla royalties in January 2019.
Capital expenditures were $2.1 million and $1.0 million for the
first quarter of 2019 and 2018, respectively.
FINANCIAL GUIDANCEImmunoGen will provide an update on the
Company’s 2019 financial guidance following the completion of the
operational review.
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 323-994-2093; the conference ID
is 8980567. The call may also be accessed through the Investors and
Media 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 17, 2019.
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.” The
Company has built a productive platform generating a broad pipeline
of ADCs targeting solid tumors and hematologic malignancies.
Learn more about who we are, what we do, and how we do it at
www.immunogen.com.
Kadcyla® and Avastin® are registered trademarks of
Genentech, a member of the Roche Group.
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 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, 2018 and other reports filed with
the Securities and Exchange Commission.
IMMUNOGEN, INC. SELECTED FINANCIAL
INFORMATION(in thousands, except per share amounts)
CONDENSED CONSOLIDATED BALANCE
SHEETS (Unaudited) March 31,2019
December 31,2018 ASSETS Cash and cash
equivalents $ 270,396 $ 262,252 Other assets 53,529
33,129 Total assets $ 323,925 $ 295,381
LIABILITIES AND SHAREHOLDERS' (DEFICIT) EQUITY
Current portion of deferred revenue $ 317 $ 317 Other current
liabilities 61,109 70,343 Long-term portion of deferred revenue
145,693 80,485 Other long-term liabilities 144,410 133,264
Shareholders' (deficit) equity (27,604 ) 10,972
Total liabilities and shareholders' (deficit) equity
$ 323,925 $ 295,381
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
Three Months EndedMarch 31, 2019
2018 Revenues: Non-cash royalty revenue $ 8,488 $
7,190 License and milestone fees 79 11,540 Research and development
support 17 383 Clinical materials revenue -
702 Total revenues 8,584 19,815
Expenses: Research and development 38,893 44,831
General and administrative 10,778 9,995 Restructuring charge
559 1,731 Total operating expenses
50,230 56,557 Loss from
operations (41,646 ) (36,742 ) Non-cash interest expense on
liability related to sale of future royalty & convertible bonds
(3,432 ) (3,046 ) Interest expense on convertible bonds (24 ) (24 )
Other income, net 1,351 1,199
Net loss $ (43,751 ) $ (38,613 )
Net loss per common
share, basic and diluted $ (0.30 )
$ (0.30 ) Weighted average common
shares outstanding, basic and diluted 147,813
130,619
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version on businesswire.com: https://www.businesswire.com/news/home/20190503005035/en/
INVESTOR RELATIONS CONTACTSarah
Kiely781-895-0600sarah.kiely@immunogen.comMEDIA
CONTACTCourtney
O’Konek781-895-0600courtney.okonek@immunogen.comORFTI
ConsultingRobert
Stanislaro212-850-5657robert.stanislaro@fticonsulting.com
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