Registration Study for Mirvetuximab Soravtansine in Ovarian
Cancer on Track to Start by Year-End
Full Data from the Phase 3 FORWARD I Trial and Initial FORWARD
II Triplet Data to be Presented at ESMO
Recommended Phase 2 Dose and Schedule for IMGN632 Determined;
Combination and MRD+ Protocol Filed
Updated 2019 Financial Guidance Provided
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 June 30, 2019.
“In the second quarter, we took important steps towards
finalizing the design of the registration study for mirvetuximab
soravtansine in folate receptor alpha (FRα)-high platinum-resistant
ovarian cancer, prioritizing our portfolio of earlier-stage product
candidates, and extending our cash runway with the completion of
our operational review,” said Mark Enyedy, ImmunoGen’s President
and Chief Executive Officer. “Over the back half of 2019, we plan
to meet with regulators regarding the final design of the
registration study for mirvetuximab with the goal of initiating
enrollment by end of year. Additionally, we look forward to
presenting the full FORWARD I data and initial FORWARD II triplet
data evaluating mirvetuximab in combination with carboplatin and
Avastin® (bevacizumab) at ESMO.”
Enyedy continued, “In parallel, we have determined a recommended
Phase 2 dose and schedule for IMGN632 and filed a protocol to
support combination studies, as well as evaluate single-agent
safety and efficacy in acute myeloid leukemia (AML) patients with
minimal residual disease (MRD+) following frontline induction
therapy. With the benefit of approximately $240 million on the
balance sheet and the completion of our operational review, we are
in a strong financial position to execute across our prioritized
portfolio.”
RECENT PROGRESS
- Presented mature data demonstrating significant anti-tumor
activity, as well as favorable safety and tolerability, from the
FORWARD II expansion cohort evaluating mirvetuximab in combination
with bevacizumab in patients with FRα-positive platinum-resistant
ovarian cancer at the American Society of Clinical Oncology (ASCO)
Annual Meeting in June.
- Accelerated enrollment in the FORWARD II mirvetuximab plus
bevacizumab combination cohort in ovarian cancer patients for whom
a non-platinum-based regimen would be an appropriate next
therapy.
- Determined the recommended Phase 2 dose and schedule for
IMGN632 and filed the protocol to initiate combination studies with
Vidaza® (azacitidine) and Venclexta® (venetoclax) in
relapsed/refractory AML patients and to evaluate IMGN632 in MRD+
patients following frontline induction therapy.
- Continued enrollment in the Phase 1 expansion study of IMGN632
in patients with blastic plasmacytoid dendritic cell neoplasm
(BPDCN).
- Advanced IND-enabling activities for IMGC936, a novel
ADAM9-targeting ADC in co-development with MacroGenics.
- Completed operational review expected to extend the Company’s
cash runway through the readout of the mirvetuximab pivotal study
in platinum-resistant ovarian cancer.
ANTICIPATED UPCOMING EVENTS
- Meet with the United States Food and Drug Administration (FDA)
and European Medicines Agency (EMA) in the second half of this year
to review the design of the next Phase 3 study of mirvetuximab
soravtansine.
- Complete enrollment in the FORWARD II mirvetuximab plus
bevacizumab combination cohort in the third quarter.
- Present full FORWARD I data (oral presentation) and initial
FORWARD II triplet data (poster presentation) at the European
Society for Medical Oncology (ESMO) Congress in late
September.
- Initiate the Phase 3 registration study of mirvetuximab as a
monotherapy for women with FRα-high, platinum-resistant ovarian
cancer by the end of this year.
- Commence enrollment in the IMGN632 combination and single-agent
MRD+ Phase 2 cohorts.
- Present preclinical combination and updated monotherapy data
for IMGN632 at the American Society of Hematology (ASH)
Congress.
FINANCIAL RESULTS
Revenues for the quarter ended June 30, 2019 were $15.5 million,
compared with $9.3 million for the quarter ended June 30, 2018.
Revenues in the second quarter of 2019 included $10.4 million in
non-cash royalty revenues, compared with $7.2 million for the
second quarter of 2018. License and milestone fees of $5.1 million
for the second quarter of 2019 included recognition and receipt of
a $5 million milestone pursuant to a license agreement with
Genentech, a member of the Roche Group, compared to $1.3 million of
upfront license fees recognized in the second quarter of 2018.
Revenues for the prior year period also included $0.4 million of
research and development (R&D) support fees and $0.3 million of
clinical materials revenue, compared with $0.1 million of similar
fees earned in the current period.
Operating expenses for the second quarter of 2019 were $56.6
million, compared with $48.0 million for the same quarter in 2018.
The increase was driven by a $19.3 million restructuring charge
recorded in the current period resulting from the operational
changes announced on June 27, 2019, which includes a one-time
severance charge, retention costs, and losses recorded on
laboratory equipment, compared to a $0.7 million charge recorded in
the second quarter of 2018 related to the decommissioning of the
Company’s Norwood facility. R&D expenses were $28.6 million in
the second quarter of 2019, compared with $38.7 million for the
second quarter of 2018. This decrease was primarily due to lower
personnel expenses driven by adjustments made in the current
quarter to bonus and stock compensation expense as a result of the
restructuring of the business, 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, and lower external
manufacturing costs. General and administrative expenses were flat
at $8.7 million in the second quarter of both 2019 and 2018.
ImmunoGen reported a net loss of $43.4 million, or $0.29 per
basic and diluted share, for the second quarter of 2019, compared
with a net loss of $41.6 million, or $0.31 per basic and diluted
share, for the same quarter last year. Weighted average shares
outstanding increased to 148.1 million from 134.4 million in those
quarters.
ImmunoGen had $239.8 million in cash and cash equivalents as of
June 30, 2019, compared with $262.3 million as of December 31,
2018, and had $2.1 million of convertible debt outstanding in each
period. Cash used in operations was $20.8 million for the first six
months of 2019, compared with cash used in operations of $85.3
million for the same period in 2018. The current period benefited
from $65.2 million of net proceeds generated from the sale of the
Company’s residual rights to Kadcyla® (ado-trastuzumab emtasine)
royalties in January 2019. Capital expenditures were $2.4 million
and $2.1 million for the first six months of 2019 and 2018,
respectively.
FINANCIAL GUIDANCE
Following the completion of its operational review in June 2019,
ImmunoGen has updated its financial guidance for 2019 as
follows:
- revenues between $40 million and $45 million;
- operating expenses between $175 million and $180 million;
and
- cash and cash equivalents at December 31, 2019, between $165
million and $170 million.
ImmunoGen expects that its current cash, together with expense
reductions resulting from the operational changes previously
announced and anticipated cash receipts from partners, will fund
operations through the release of top-line results from the
upcoming mirvetuximab Phase 3 study in platinum-resistant ovarian
cancer, which are expected in the first half of 2022.
CONFERENCE CALL INFORMATION
ImmunoGen will hold a conference call today at 8:00 a.m. ET to
discuss these results. To access the live call by phone, dial
+1-323-794-2093; the conference ID is 9100112. The call may also be
accessed through the Investors and Media section of the Company’s
website at www.immunogen.com.
ABOUT IMMUNOGEN
ImmunoGen 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.”
Learn more about who we are, what we do, and how we do it at
www.immunogen.com.
Avastin®, Vidaza®, Venclexta®, and Kadcyla® are registered
trademarks of their respective owners.
FORWARD-LOOKING STATEMENTS
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
occurrence, timing, and outcome of potential pre-clinical,
clinical, and regulatory events related to the Company’s 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 results of communications with FDA, risks and
uncertainties related to the execution of the restructuring of the
Company’s operations, the Company’s ability to control future
spending to enable it to fund its remaining operations through the
release of top-line results from the upcoming mirvetuximab pivotal
study, as well as the risks and uncertainties inherent in the
Company’s development programs, including clinical studies and
regulatory processes, their timings and results. A review of these
risks can be found 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.
SELECTED FINANCIAL
INFORMATION
(in thousands, except per
share amounts)
CONDENSED CONSOLIDATED BALANCE
SHEETS
(Unaudited)
June 30,
December 31,
2019
2018
ASSETS Cash and cash equivalents
$
239,825
$
262,252
Other assets
47,844
33,129
Total assets
$
287,669
$
295,381
LIABILITIES AND SHAREHOLDERS' (DEFICIT) EQUITY
Current portion of deferred revenue
$
317
$
317
Other current liabilities
74,299
70,343
Long-term portion of deferred revenue
145,614
80,485
Other long-term liabilities
135,613
133,264
Shareholders' (deficit) equity
(68,174
)
10,972
Total liabilities and shareholders' (deficit) equity
$
287,669
$
295,381
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended
Six Months Ended
June 30,
June 30,
2019
2018
2019
2018
Revenues: Non-cash
royalty revenue
$
10,412
$
7,242
$
18,900
$
14,432
License and milestone fees
5,079
1,321
5,158
12,861
Research and development support
51
388
68
771
Clinical materials revenue
-
336
-
1,038
Total revenues
15,542
9,287
24,126
29,102
Expenses: Research
and development
28,559
38,701
67,452
83,532
General and administrative
8,700
8,652
19,478
18,647
Restructuring charge
19,342
686
19,901
2,417
Total operating expenses
56,601
48,039
106,831
104,596
Loss from operations
(41,059
)
(38,752
)
(82,705
)
(75,494
)
Non-cash interest expense on liability
related to sale of future royalty & convertible bonds
(3,818
)
(2,611
)
(7,250
)
(5,657
)
Interest expense on convertible bonds
(23
)
(23
)
(47
)
(47
)
Other income (loss), net
1,454
(238
)
2,805
961
Net loss
$
(43,446
)
$
(41,624
)
$
(87,197
)
$
(80,237
)
Basic and dilued net loss per common
share
$
(0.29
)
$
(0.31
)
$
(0.59
)
$
(0.61
)
Basic
and diluted weighted average common shares outstanding
148,129
134,384
147,972
132,512
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190802005046/en/
INVESTOR RELATIONS AND MEDIA ImmunoGen Courtney O’Konek
781-895-0600 courtney.okonek@immunogen.com
OR
FTI Consulting Robert Stanislaro 212-850-5657
robert.stanislaro@fticonsulting.com
ImmunoGen (NASDAQ:IMGN)
Historical Stock Chart
From Jun 2024 to Jul 2024
ImmunoGen (NASDAQ:IMGN)
Historical Stock Chart
From Jul 2023 to Jul 2024