Positive Top-Line Data from Pivotal SORAYA Trial of Mirvetuximab
Soravtansine in Ovarian Cancer; Detailed Results to be Presented in
Plenary Session at SGO in March
Mirvetuximab BLA On Track for Submission this Quarter
IMGN632 Triplet Data Demonstrating Manageable Safety Profile and
Encouraging Activity in AML Highlighted in Oral Presentation at ASH
2021; Top-Line Data from Pivotal CADENZA Trial of IMGN632 in BPDCN
Expected in H2 2022
Appointments of Chief Commercial Officer and Head of Medical
Affairs Support Transition to a Fully-Integrated Oncology
Company
Ended 2021 with over $475 Million of Cash on the Balance
Sheet, Extending Anticipated Cash Runway into 2024
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 and year ended December 31,
2021.
“2021 was a productive year for ImmunoGen, highlighted by
positive pivotal data for our lead program, advances across our
earlier-stage portfolio, and further strengthening our balance
sheet and management team,” said Mark Enyedy, ImmunoGen’s President
and Chief Executive Officer. “The top-line SORAYA data provide the
opportunity to establish mirvetuximab soravtansine as the new
standard of care for patients with FRα-positive platinum-resistant
ovarian cancer, and we look forward to presenting detailed results
from SORAYA during the plenary session at SGO next month.”
Enyedy continued, “We also formalized our plans to expand
mirvetuximab into platinum-sensitive disease as a monotherapy and
in combinations to serve a broader population of ovarian cancer
patients, presented promising initial data for IMGN632, now known
as pivekimab sunirine, in relapsed/refractory AML and frontline
BPDCN at ASH, continued dose-escalation for IMGC936, and submitted
the IND for IMGN151. Together with the appointment of key
leadership positions and an oversubscribed follow-on offering in
the fourth quarter, this progress positions us for success in 2022
and beyond. We have an exciting year ahead, with the potential
launch of our first product, top-line data for our second pivotal
program, advancement of our earlier-stage portfolio, and further
building our pipeline and research capabilities.”
RECENT PROGRESS
- Reported positive top-line data from SORAYA, a pivotal
single-arm study of mirvetuximab soravtansine (mirvetuximab) in
folate receptor alpha (FRα)-high platinum-resistant ovarian cancer
in patients previously treated with Avastin® (bevacizumab).
- Continued patient enrollment in the confirmatory MIRASOL
study.
- Initiated accrual in PICCOLO, a single-arm study of
mirvetuximab monotherapy in FRα-high recurrent platinum-sensitive
ovarian cancer.
- Aligned with the US Food and Drug Administration (FDA) on the
design for GLORIOSA, a randomized Phase 3 study of mirvetuximab in
combination with bevacizumab maintenance in FRα-high
platinum-sensitive ovarian cancer.
- Supported 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.
- Continued the pivotal Phase 2 CADENZA study of pivekimab
sunirine (pivekimab, formerly IMGN632) in frontline and
relapsed/refractory (R/R) blastic plasmacytoid dendritic cell
neoplasm (BPDCN).
- Presented initial data from the Phase 1b/2 study of pivekimab
in combination with Vidaza® (azacitidine) and Venclexta®
(venetoclax) in R/R acute myeloid leukemia (AML) in an oral
session, and initial frontline BPDCN data in a poster session, at
the 2021 American Society of Hematology (ASH) Annual Meeting.
- Opened an expansion cohort combining pivekimab, azacitidine,
and venetoclax in unfit relapsed AML.
- Advanced dose escalation in the Phase 1 study of IMGC936 in
multiple solid tumor types.
- Submitted the investigational new drug (IND) application for
IMGN151.
- Appointed Kristen Harrington-Smith as Chief Commercial Officer,
Mimi Huizinga, MD, MPH, FACP as Head of Medical Affairs, and Tracey
L. McCain, Esq. to the Board of Directors.
- Announced a global licensing agreement granting Eli Lilly and
Company (Lilly) exclusive rights to research, develop, and
commercialize ADCs directed to targets selected by Lilly based on
ImmunoGen’s novel camptothecin technology.
ANTICIPATED UPCOMING EVENTS
- Present full SORAYA data during the plenary session at the
Society of Gynecologic Oncology (SGO) Annual Meeting in March.
- Submit the biologics license application (BLA) to the FDA for
mirvetuximab in FRα-high platinum-resistant ovarian cancer in the
first quarter of 2022 to support potential accelerated approval and
launch.
- Generate top-line data for the confirmatory MIRASOL study in
the third quarter of 2022.
- Initiate GLORIOSA, a randomized Phase 3 trial of mirvetuximab
in combination with bevacizumab maintenance in FRα-high
platinum-sensitive ovarian cancer, in the second quarter of
2022.
- Initiate Trial 0420, a single-arm Phase 2 trial of mirvetuximab
in combination with carboplatin followed by mirvetuximab
continuation in FRα-low, medium, and high patients with
platinum-sensitive ovarian cancer, in the second quarter of
2022.
- Report top-line data from the pivotal CADENZA study of
pivekimab in BPDCN in the second half of 2022.
- Initiate expansion cohort combining pivekimab, azacitidine, and
venetoclax in frontline AML.
- Complete dose-escalation in the Phase 1 study evaluating
IMGC936, with initial data anticipated in 2022.
- Begin enrollment in the Phase 1 study of IMGN151 following
submission of chemistry, manufacturing, and controls (CMC)
information to the FDA.
FINANCIAL RESULTS
Total revenues were $28.0 million for the quarter ended December
31, 2021 compared to $85.8 million for the quarter ended December
31, 2020, and $69.9 million for the year ended December 31, 2021
compared to $132.3 million for the year ended December 31, 2020.
The decrease in both periods was driven by the recognition of a
$60.5 million upfront fee received under the Company’s
collaboration agreement with Jazz Pharmaceuticals during the
quarter and year ended December 31, 2020 and a reduction in
non-cash royalty revenue in 2021 due to the completion of the first
tranche of payments under the 2015 Kadcyla® royalties agreement.
Partially offsetting these decreases, during the quarter and year
ended December 31, 2021, the Company recognized $14.6 million of
the $40.0 million upfront fee previously received pursuant to the
Company’s collaboration agreement with Huadong Medicine.
Research and development expenses rose to $49.0 million for the
quarter ended December 31, 2021 compared to $39.6 million for the
quarter ended December 31, 2020, and $151.1 million for the year
ended December 31, 2021 compared to $114.6 million for the year
ended December 31, 2020. The increases in both periods were driven
by greater clinical trial expenses, personnel and temporary
staffing costs, external manufacturing costs, and third-party
service fees in support of commercial readiness.
General and administrative expenses were $13.6 million for the
quarter ended December 31, 2021 compared to $9.7 million for the
quarter ended December 31, 2020, and $43.8 million for the year
ended December 31, 2021 compared to $38.6 million for the year
ended December 31, 2020. The increases in both periods were driven
by higher professional fees and personnel expenses, including
greater non-cash stock compensation expense.
Net loss for the fourth quarter of 2021 was $(37.2) million, or
$(0.17) per diluted share, compared to net income of $31.4 million,
or $0.16 per diluted share, for the fourth quarter of 2020. Net
loss for the year ended December 31, 2021 was $(139.3) million, or
$(0.68) per diluted share, compared to a net loss of $(44.4)
million, or $(0.25) per diluted share, for the year ended December
31, 2020.
ImmunoGen had $478.8 million in cash and cash equivalents as of
December 31, 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
December 31, 2021. Cash used in operations was $169.4 million for
the year ended December 31, 2021 compared with $78.6 million for
the year ended December 31, 2020, with the prior year benefitting
from a $40 million upfront license payment received from Huadong
Medicine and lower operating expenses for the year as discussed
above. Capital expenditures were $(1.4) million for year ended
December 31, 2021, compared with $0.5 million of net proceeds from
the sale of equipment in the year ended December 31, 2020.
FINANCIAL GUIDANCE
For 2022, ImmunoGen expects:
- revenues between $75 million and $85 million;
- operating expenses between $285 million and $295 million;
and
- cash and cash equivalents at December 31, 2022, to be between
$245 million and $255 million.
Given the range in timing for potential approval, revenue
guidance does not yet include potential product sales from
mirvetuximab.
ImmunoGen expects that its current cash, combined with
anticipated product and collaboration revenues, will fund
operations into 2024.
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 5566069. 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.
Avastin®, Vidaza®, Venclexta®, and Kadcyla® are registered
trademarks of their respective owners.
FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. These
statements include, but are not limited to, ImmunoGen’s
expectations related to: the Company’s revenues and operating
expenses for 2022 and its cash and cash equivalents as of December
31, 2022; the Company’s anticipated cash runway; 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, but not limited to: the
submission of the Company’s BLA to the FDA for mirvetuximab, the
potential accelerated approval and commercial launch of
mirvetuximab, the initiation of Trial 0420, the GLORIOSA Phase 3
trial, the expansion cohort combining pivekimab, azacitidine, and
venetoclax in frontline AML, the completion of the dose-escalation
Phase 1 study evaluating IMGC936 and the enrollment of patients in
a Phase 1 study for IMGN151; the timing and presentation of
preclinical and clinical data on the Company’s product candidates,
including full SORAYA data, top-line data for the MIRASOL study,
top-line data from the CADENZA study, and initial data from the
Phase 1 dose-escalation study evaluating IMGNC936; and the
Company’s business and product development strategies. 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, including
that the FDA may determine that our BLA for mirvetuximab does not
meet the conditions for accelerated approval; 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. The forward-looking statements
in this press release speak only as of the date of this press
release. We undertake no obligation to update any forward-looking
statement, whether as a result of new information, future
developments or otherwise, except as may be required by applicable
law.
IMMUNOGEN, INC. SELECTED FINANCIAL INFORMATION (in
thousands, except per share amounts) CONDENSED
CONSOLIDATED BALANCE SHEETS (Unaudited)
December 31, December 31,
2021
2020
ASSETS Cash and cash equivalents $
478,750
$
293,856
Other assets
47,015
61,216
Total assets $
525,765
$
355,072
LIABILITIES AND SHAREHOLDERS' EQUITY Current portion
of deferred revenue $
44,351
$
29,249
Other current liabilities
56,594
93,074
Long-term portion of deferred revenue
47,717
80,860
Other long-term liabilities
51,517
62,319
Shareholders' equity
325,586
89,570
Total liabilities and shareholders' equity $
525,765
$
355,072
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (Unaudited) Three Months Ended Year
Ended December 31, December 31,
2021
2020
2021
2020
Revenues: License and milestone fees $
19,564
$
62,417
$
22,650
$
63,742
Non-cash royalty revenue
8,040
23,370
46,808
68,529
Research and development support
388
11
398
28
Total revenues
27,992
85,798
69,856
132,299
Expenses: Research and development
48,968
39,578
151,117
114,592
General and administrative
13,578
9,738
43,812
38,600
Restructuring charge
-
(37
)
-
1,487
Total operating expenses
62,546
49,279
194,929
154,679
(Loss) income from operations
(34,554
)
36,519
(125,073
)
(22,380
)
Non-cash interest expense on liability related to sale of
future royalty & convertible bonds
(2,151
)
(5,679
)
(13,103
)
(23,107
)
Interest expense on convertible bonds
-
(24
)
(47
)
(95
)
Other (loss) income, net
(467
)
572
(1,080
)
1,210
Net (loss) income $
(37,172
)
$
31,388
$
(139,303
)
$
(44,372
)
Net (loss) income per common share - basic $
(0.17
)
$
0.17
$
(0.68
)
$
(0.25
)
Net (loss) income per common share - diluted $
(0.17
)
$
0.16
$
(0.68
)
$
(0.25
)
Shares used in computation of per share amounts -
basic
215,830
188,681
206,147
176,153
Shares used in computation of per share amounts -
diluted
215,830
191,089
206,147
176,153
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220225005018/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
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