Compelling Final Data from FORWARD II Study Combining
Mirvetuximab Soravtansine with Avastin® in Recurrent Ovarian
Cancer, Regardless of Platinum Status, Presented at ASCO
Top-line Data from Pivotal SORAYA Trial on Track for Q4
Continued Progress in Ongoing MIRASOL, IMGN632, and IMGC936
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, 2021.
"With top-line data from our pivotal SORAYA trial on track for
release in Q4, we have accelerated preparations for the BLA
submission and commercial launch of mirvetuximab. In parallel, we
continue to generate data that support mirvetuximab as the
combination agent of choice for ovarian cancer patients," said Mark
Enyedy, ImmunoGen's President and Chief Executive Officer. "At
ASCO, we presented final data from our mirvetuximab plus Avastin®
doublet, showing compelling and durable anti-tumor activity, with a
64% ORR, 11.8 month mDOR, and 10.6 month mPFS in patients with high
FRα recurrent ovarian cancer, regardless of platinum status. We
believe these data are highly encouraging, particularly given
outcomes with available therapies in this setting. As we continue
to accrue our confirmatory MIRASOL trial, we are working to
establish mirvetuximab as the new standard of care in patients with
high FRα ovarian cancer, who comprise roughly 40% of the market. To
this end, this quarter we are initiating PICCOLO, a single-arm
study of mirvetuximab monotherapy in recurrent platinum-sensitive
ovarian cancer to support label expansion."
Enyedy added, "Beyond mirvetuximab, our IMGN632, IMGC936, and
IMGN151 programs are progressing as anticipated. Patient accrual
continues in our IMGN632 trials in BPDCN and AML, with data from
our AML cohort expected at ASH next quarter. Our dose-escalation
study of IMGC936 is enrolling in multiple solid tumor types and we
are on track to file the IND for IMGN151 by year-end. With a focus
on execution towards key inflection points, we look forward to
transforming ImmunoGen into a fully integrated oncology company
with the potential for two innovative ADCs on the market in
- Presented final data from the FORWARD II study evaluating
mirvetuximab in combination with Avastin® (bevacizumab) in patients
with medium and high folate receptor alpha (FRα)-expressing
recurrent ovarian cancer for whom a non-platinum based combination
regimen is appropriate at the 2021 American Society of Clinical
Oncology (ASCO) Virtual Annual Meeting.
- Completed accrual in the pivotal SORAYA study and further
enrolled patients in the confirmatory MIRASOL study for
- Supported enrollment of investigator-sponsored trials of
mirvetuximab plus carboplatin in a single-arm study in the
neoadjuvant setting and in a randomized study in patients with
recurrent platinum-sensitive ovarian cancer.
- Advanced accrual in the pivotal 801 Phase 2 study of IMGN632 in
frontline and relapsed/refractory (R/R) blastic plasmacytoid
dendritic cell neoplasm (BPDCN).
- Continued patient enrollment in the 802 Phase 1b/2 study of
IMGN632 in combination with Vidaza® (azacitidine) and Venclexta®
(venetoclax) in R/R acute myeloid leukemia (AML) patients and as a
monotherapy in minimal residual disease positive (MRD+) AML.
- Escalated dosing in the Phase 1 study of IMGC936 in multiple
solid tumor types.
- Progressed activities to support an investigational new drug
(IND) application for IMGN151.
ANTICIPATED UPCOMING EVENTS
- Release top-line data from the pivotal SORAYA study in the
fourth quarter of 2021 and submit the biologics license application
(BLA) in the first quarter of 2022 to support potential accelerated
approval in 2022.
- Generate top-line data for the confirmatory MIRASOL study in
the third quarter of 2022.
- Enroll the first patient in PICCOLO, a single-arm study of
mirvetuximab monotherapy in high FRα recurrent platinum-sensitive
ovarian cancer, in the third quarter of 2021, designed to support
potential label expansion.
- Present initial AML combination data for IMGN632 at the 2021
American Society of Hematology (ASH) Annual Meeting in December
- Complete dose-escalation in the Phase 1 study evaluating
IMGC936, with initial data anticipated in early 2022.
- Submit the IND application for IMGN151 by the end of 2021.
Revenues for the quarter ended June 30, 2021 were $16.9 million,
compared with $15.0 million for the quarter ended June 30, 2020,
which consisted primarily of non-cash royalty revenues.
Operating expenses for the second quarter of 2021 were $44.3
million, compared with $33.4 million for the same quarter in 2020.
The increase was largely driven by research and development
expenses, which were $34.6 million for the second quarter of 2021,
compared with $22.9 million for the second quarter of 2020. This
increase was due to greater clinical trial expenses driven by costs
related to the MIRASOL, SORAYA, and IMGC936 studies, greater
personnel and temporary staffing costs, and higher external
manufacturing costs and third-party service fees in support of
commercial readiness. General and administrative expenses for the
second quarter of 2021 were $9.7 million, compared to $9.8 million
for the second quarter of 2020.
Net loss for the second quarter of 2021 was $30.7 million, or
$0.15 per basic and diluted share, compared to a net loss of $24.3
million, or $0.14 per basic and diluted share, for the second
quarter of 2020. Weighted average shares outstanding increased to
199.9 million for the 2021 period from 174.4 million in the prior
ImmunoGen had $239.5 million in cash and cash equivalents as of
June 30, 2021, compared with $293.9 million as of December 31,
2020, and had $1.1 million of convertible debt outstanding as of
June 30, 2021, compared with $2.1 million as of December 31, 2020.
Cash used in operations was $88.5 million for the first six months
of 2021, compared with cash used in operations of $56.5 million for
the same period in 2020. Capital expenditures were $(0.9) million
for the first six months of 2021, compared with net proceeds from
the sale of equipment of $1.4 million for the first six months of
ImmunoGen's financial guidance for 2021 remains unchanged:
- revenues between $65 million and $75 million;
- operating expenses between $200 million and $210 million;
- cash and cash equivalents at December 31, 2021 to be between
$140 million and $150 million.
ImmunoGen expects that its current cash will fund operations
into the second 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 (877)
621-5803; the conference ID is 1789134. The call may also be
accessed through the Investors and Media section of the Company's
website, www.immunogen.com. Following the call, a replay will be
available at the same location.
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
Avastin®, Vidaza®, and Venclexta® are registered trademarks of
their respective owners.
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, 2021; its cash and cash equivalents as of
December 31, 2021; how long its current cash will fund operations,
the occurrence, timing, and outcome of potential preclinical,
clinical, and regulatory events related to the Company's product
candidates; and the presentation of preclinical and clinical data
on 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
outcome of the Company's preclinical 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; the Company's ability to financially support its product
programs; risks and uncertainties associated with the scale and
duration of the COVID-19 pandemic and the resulting impact on
ImmunoGen's industry and business; and other factors as set forth
in the Company's Annual Report on Form 10-K filed with the
Securities and Exchange Commission on March 1, 2021, 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) June
30, December 31,
ASSETS Cash and cash equivalents $
Total assets $
LIABILITIES AND SHAREHOLDERS' EQUITY Current portion
of deferred revenue $
Other current liabilities
Long-term portion of deferred revenue
Other long-term liabilities
Total liabilities and shareholders' equity $
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (Unaudited) Three Months Ended Six
Months Ended June 30, June 30,
Revenues: Non-cash royalty revenue $
License and milestone fees
Research and development support
Expenses: Research and development
General and administrative
Total operating expenses
Loss from operations
Non-cash interest expense on liability related to sale of
future royalty & convertible bonds
Interest expense on convertible bonds
Other income (loss), net
Net loss $
Basic and diluted net loss per common share $
Basic and diluted weighted average common shares
version on businesswire.com: https://www.businesswire.com/news/home/20210730005064/en/
INVESTOR RELATIONS AND MEDIA CONTACTS ImmunoGen Courtney
O'Konek 781-895-0600 firstname.lastname@example.org OR FTI
Consulting Robert Stanislaro 212-850-5657
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