Top-Line Data from Pivotal SORAYA Trial Evaluating Mirvetuximab
Soravtansine in Platinum-Resistant Ovarian Cancer on Track for
Release this Quarter
IMGN632 AML Combination Data to be Highlighted at ASH Annual
Meeting
PICCOLO, Single-Arm Study of Mirvetuximab in Platinum-Sensitive
Ovarian Cancer, Open for Enrollment
Earlier-Stage Pipeline Continues to Progress
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 September 30, 2021.
"We look forward to announcing top-line data from our pivotal
SORAYA trial this quarter, including data on the primary endpoint
of overall response rate and key secondary endpoint of duration of
response. With positive data, we will move quickly to complete the
BLA, with the goal of submitting the filing in the first quarter of
2022," said Mark Enyedy, ImmunoGen's President and Chief Executive
Officer. "In addition to SORAYA, we continue to advance a broad
program to establish mirvetuximab as the standard of care for
patients with FRα-positive ovarian cancer. Our confirmatory MIRASOL
trial is enrolling at over 160 sites in 18 countries in North
America, Europe, Asia, and Australia, and we have initiated the
PICCOLO trial, which could support label expansion in recurrent
platinum-sensitive ovarian cancer. Beyond mirvetuximab monotherapy,
the first patients have been enrolled in the large
investigator-sponsored studies evaluating mirvetuximab combined
with carboplatin in both the neoadjuvant and recurrent
platinum-sensitive settings to support our objective of making
mirvetuximab the combination agent of choice in ovarian cancer, and
we look forward to sharing our label-enabling combination strategy
early next year."
Enyedy continued, "In addition, our IMGN632, IMGC936, and
IMGN151 programs are advancing as planned. We anticipate presenting
data on IMGN632 in AML at ASH in December, have escalated dosing in
multiple solid tumors with our ADAM-9 targeting ADC, IMGC936, and
expect to file the IND for IMGN151, our next-generation
FRα-targeting ADC, by year-end. As we close out 2021, we remain
focused on execution and look forward to transforming ImmunoGen
into a fully integrated oncology company with the potential for
commercial launch next year."
RECENT PROGRESS
- Further enrolled patients in the confirmatory MIRASOL study for
mirvetuximab.
- Initiated PICCOLO, a single-arm study of mirvetuximab
monotherapy in high folate receptor alpha (FRα) recurrent
platinum-sensitive ovarian cancer.
- Enrolled the first patients in the investigator-sponsored
trials of mirvetuximab plus carboplatin in a single-arm study in
the neoadjuvant setting and a randomized study in patients with
recurrent platinum-sensitive ovarian cancer.
- Advanced accrual in the pivotal 801 Phase 2 study, now known as
CADENZA, 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.
- Appointed Helen M. Thackray, MD, to the Board of
Directors.
ANTICIPATED UPCOMING EVENTS
- Release top-line data from the pivotal SORAYA study this
quarter, with the goal of submitting the biologics license
application (BLA) in the first quarter of 2022 to support potential
accelerated approval in 2022.
- Present initial AML combination data for IMGN632 at the 2021
American Society of Hematology (ASH) Annual Meeting in
December.
- Submit the IND application for IMGN151 by the end of 2021.
- Complete dose-escalation in the Phase 1 study evaluating
IMGC936, with initial data anticipated in 2022.
- Generate top-line data for the confirmatory MIRASOL study in
the third quarter of 2022.
FINANCIAL RESULTS
Revenues for the quarter ended September 30, 2021 were $9.2
million, compared with $18.2 million for the quarter ended
September 30, 2020. This decrease was driven by a reduction in
non-cash royalty revenue due to the completion of the first tranche
of payments under the 2015 transaction covering the sale of
Kadcyla® royalties. Revenues for the quarter ended September 30,
2021 also included recognition of an anticipated $2.5 million
partner development milestone fee.
Operating expenses for the third quarter of 2021 were $43.4
million, compared with $34.9 million for the same quarter in 2020.
Research and development expenses rose to $33.1 million for the
third quarter of 2021, compared with $24.7 million for the third
quarter of 2020, driven by increases in clinical trial expenses,
personnel and temporary staffing costs, and third-party service
fees in support of commercial readiness. General and administrative
expenses were essentially flat at $10.3 million and $10.2 million
for the third quarters of 2021 and 2020, respectively.
Net loss for the third quarter of 2021 was $37.3 million, or
$0.18 per basic and diluted share, compared to a net loss of $22.4
million, or $0.13 per basic and diluted share, for the third
quarter of 2020. Weighted average shares outstanding increased to
204.8 million for the 2021 period from 174.5 million in the prior
year.
ImmunoGen had $245.8 million in cash and cash equivalents as of
September 30, 2021, compared with $293.9 million as of December 31,
2020, and had $2.1 million of convertible debt outstanding as of
December 31, 2020. There was no convertible debt outstanding as of
September 30, 2021. Cash used in operations was $123.5 million for
the first nine months of 2021, compared with cash used in
operations of $87.2 million for the same period in 2020. Capital
expenditures were $(1.1) million for the first nine months of 2021,
compared with net proceeds from the sale of equipment of $0.6
million for the first nine months of 2020.
During the quarter ended September 30, 2021, the Company sold
2.2 million shares of its common stock through its At-the-Market
(ATM) facility, generating gross proceeds to the Company of
approximately $13 million. In August 2021, the Company entered into
a Securities Purchase Agreement pursuant to which the Company
agreed to sell to an investor a warrant to purchase up to an
aggregate of 5,434,782 shares of the Company's common stock for a
nominal value, generating additional gross proceeds of
approximately $30 million.
FINANCIAL GUIDANCE
ImmunoGen has updated its financial guidance for 2021 and now
expects:
- revenues between $65 million and $75 million;
- operating expenses between $190 million and $200 million;
and
- cash and cash equivalents at December 31, 2021 to be between
$190 million and $200 million.
ImmunoGen expects that its current cash will fund operations
into the fourth quarter 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 1587202. 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.
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.
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
Company's revenues and operating expenses for 2021 and its cash and
cash equivalents as of December 31, 2021; how long its current cash
is expected to fund operations; the occurrence, timing, and outcome
of potential preclinical, clinical, and regulatory events related
to, and the potential benefits of, the Company's product candidates
including the submission of the Company's IND to the FDA for
IMGN151, the submission of the Company's BLA to the FDA for
mirvetuximab, and the launch of two ADCs next year; and the timing
and presentation of preclinical and clinical data on the Company's
product candidates, including the release of top-line data from the
pivotal SORAYA study in the fourth quarter of 2021 and the
confirmatory MIRASOL study in the third quarter of 2022. 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 timing and outcome of the Company's anticipated
interactions with regulatory authorities; obtaining, maintaining,
and protecting the Company's intellectual property; 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)
September 30, December 31,
2021
2020
ASSETS Cash and cash equivalents $
245,761
$
293,856
Other assets
51,042
61,216
Total assets $
296,803
$
355,072
LIABILITIES AND SHAREHOLDERS' EQUITY Current portion
of deferred revenue $
53,526
$
29,249
Other current liabilities
58,259
93,074
Long-term portion of deferred revenue
52,479
80,860
Other long-term liabilities
55,446
62,319
Shareholders' equity
77,093
89,570
Total liabilities and shareholders' equity $
296,803
$
355,072
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (Unaudited) Three Months Ended Nine
Months Ended September 30, September 30,
2021
2020
2021
2020
Revenues: Non-cash royalty revenue $
6,533
$
18,087
$
38,768
$
45,159
License and milestone fees
2,677
97
3,086
1,325
Research and development support
-
5
10
17
Total revenues
9,210
18,189
41,864
46,501
Expenses: Research and development
33,147
24,685
102,149
75,014
General and administrative
10,297
10,231
30,234
28,862
Restructuring charge
-
-
-
1,524
Total operating expenses
43,444
34,916
132,383
105,400
Loss from operations
(34,234
)
(16,727
)
(90,519
)
(58,899
)
Non-cash interest expense on liability related to sale of
future royalty & convertible bonds
(2,751
)
(5,645
)
(10,952
)
(17,428
)
Interest expense on convertible bonds
-
(24
)
(47
)
(71
)
Other (loss) income, net
(354
)
22
(613
)
638
Net loss $
(37,339
)
$
(22,374
)
$
(102,131
)
$
(75,760
)
Basic and diluted net loss per common share $
(0.18
)
$
(0.13
)
$
(0.51
)
$
(0.44
)
Basic and diluted weighted average common shares
outstanding
204,844
174,508
201,212
172,215
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211029005032/en/
INVESTOR RELATIONS AND MEDIA CONTACTS 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 Mar 2024 to Apr 2024
ImmunoGen (NASDAQ:IMGN)
Historical Stock Chart
From Apr 2023 to Apr 2024