BLA for Mirvetuximab Soravtansine Monotherapy in Ovarian Cancer
Accepted by FDA with Priority Review; PDUFA Date Set for November
28, 2022
Completed enrollment in the Confirmatory MIRASOL Study
Presented Additional Efficacy and Safety Data for Mirvetuximab
Monotherapy at ASCO; Poster Highlighting Updated SORAYA Data
Selected for Best of ASCO® Program
Announced Multi-Year Collaboration with Oxford BioTherapeutics
to Research and Develop Novel ADCs
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, 2022.
“With the BLA for MIRV accepted and receiving Priority Review
designation from FDA, we have taken a significant step closer to
bringing this important new therapy to ovarian cancer patients this
year,” said Mark Enyedy, ImmunoGen’s President and Chief Executive
Officer, “We are pleased with the positive reception our data
received at ASCO and are focused on building our commercial and
medical infrastructure to support a successful launch to establish
MIRV as the new standard of care for patients with folate receptor
alpha positive disease.”
Enyedy continued, “We have also completed accrual in MIRASOL and
expect to report data from this confirmatory study early next year.
In support of moving MIRV into broader patient populations, we are
expanding our development program and are in the process of
initiating the GLORIOSA and Trial 0420 studies. Turning to our
second pivotal program, PVEK, we expect to report preliminary
efficacy data from our pivotal CADENZA study in BPDCN this year and
plan to present initial data from our triplet expansion cohort in
AML at ASH. We have had a productive first half of the year, and
with key regulatory and clinical milestones anticipated before
year-end, we are well positioned to create meaningful value for
both patients and shareholders.”
RECENT PROGRESS
- Announced that the U.S. Food and Drug Administration (FDA)
accepted and filed the Biologics License Application (BLA) for
mirvetuximab soravtansine (mirvetuximab) monotherapy in patients
with folate receptor alpha (FRα)-high platinum-resistant ovarian
cancer who have been previously treated with one to three prior
systemic treatments with Priority Review designation.
- Completed enrollment in the confirmatory MIRASOL study.
- Presented additional efficacy data from the pivotal SORAYA
study and an integrated safety summary of single-agent mirvetuximab
across multiple studies enrolling almost 500 patients with
FRα-positive recurrent ovarian cancer at the 2022 American Society
of Clinical Oncology (ASCO) Annual Meeting in June.
- Advanced accrual in PICCOLO, a single-arm study of mirvetuximab
monotherapy in FRα-high recurrent 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.
- Progressed the pivotal Phase 2 CADENZA study of pivekimab
sunirine (pivekimab) in frontline and relapsed/refractory (R/R)
blastic plasmacytoid dendritic cell neoplasm (BPDCN).
- Continued enrollment in expansion cohorts in the Phase 1b/2
study evaluating pivekimab, Vidaza® (azacitidine), and Venclexta®
(venetoclax) in both R/R and frontline unfit acute myeloid leukemia
(AML) patients.
- Advanced dose escalation and opened additional sites in the
Phase 1 study of IMGC936 in multiple solid tumor types.
- Progressed the generation of supplemental chemistry,
manufacturing, and controls (CMC) information for submission to the
FDA to support the investigational new drug (IND) application for
IMGN151.
- Announced a multi-year collaboration to research novel,
first-in-class ADCs with Oxford BioTherapeutics (OBT) utilizing
ImmunoGen's proprietary linker-payload technology directed to novel
targets identified via OBT's proprietary OGAP® discovery
platform.
ANTICIPATED UPCOMING EVENTS
- Potential FDA approval of mirvetuximab as a monotherapy in
patients with FRα-high platinum-resistant ovarian cancer by the
Prescription Drug User Fee Act (PDUFA) action date of November 28,
2022.
- Generate top-line data for MIRASOL in early 2023.
- Enroll the first patients in two combination studies for
mirvetuximab in platinum-sensitive ovarian cancer: 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; and GLORIOSA, a randomized Phase 3 trial
of mirvetuximab in combination with bevacizumab maintenance in
FRα-high recurrent second-line platinum-sensitive ovarian
cancer.
- Present additional data from the mirvetuximab program at the
2022 European Society for Medical Oncology (ESMO) Congress and the
2022 Annual Global Meeting of the International Gynecologic Cancer
Society (IGCS) in September.
- Report preliminary efficacy data from the pivotal CADENZA study
of pivekimab in BPDCN before year-end.
- Present pivekimab efficacy data for genetic sub-types of AML at
the Society of Hematologic Oncology (SOHO) in September, and
initial data from frontline and R/R AML expansion cohorts combining
pivekimab, azacitidine, and venetoclax at the 2022 American Society
of Hematology (ASH) Annual Meeting in December.
- Complete dose-escalation in the Phase 1 study evaluating
IMGC936, with initial data anticipated before year-end.
- Begin enrollment in the Phase 1 study of IMGN151 following the
submission of supplemental CMC information to the FDA.
FINANCIAL RESULTS Total revenues were $14.2 million for
the quarter ended June 30, 2022 compared to $16.9 million for the
quarter ended June 30, 2021. The decrease was driven by lower
non-cash royalty revenue due to the completion of the first tranche
of payments under the 2015 KADCYLA® royalty agreement in the second
quarter of 2021, partially offset by greater license and milestone
fee revenue driven by the recognition of $6.9 million of fees
previously received and deferred pursuant to the Company’s
collaboration agreement with Huadong Medicine.
Operating expenses for the quarter ended June 30, 2022 were
$75.2 million, compared with $44.3 million for the same quarter in
2021. Research and development expenses rose to $51.4 million for
the quarter ended June 30, 2022 compared to $34.6 million for the
quarter ended June 30, 2021, driven by increases in clinical trial
costs, personnel and temporary staffing costs, and research
expenses to further build our ADC pipeline, which includes a $7.5
million upfront fee paid to Oxford BioTherapeutics. Selling,
general and administrative expenses increased to $23.8 million for
the quarter ended June 30, 2022 compared to $9.7 million for the
quarter ended June 30, 2021, due primarily to building commercial
capabilities, including the hiring of personnel, in anticipation of
a potential U.S. launch of mirvetuximab in the fourth quarter of
2022.
Net loss for the second quarter of 2022 was $62.0 million, or
$0.24 per basic and diluted share, compared to a net loss of $30.7
million, or $0.15 per basic and diluted share, for the second
quarter of 2021. Weighted average shares outstanding increased to
253.3 million for the 2022 period from 199.9 million in the prior
year.
ImmunoGen had $373.9 million in cash and cash equivalents as of
June 30, 2022, compared with $478.8 million as of December 31,
2021. Cash used in operations was $105.4 million for the first six
months of 2022, compared with cash used in operations of $88.5
million for the same period in 2021, with the current period
benefiting from a $13.0 million upfront license payment received
from Lilly. Capital expenditures were $0.5 million and $0.9 million
for the first six months of 2022 and 2021, respectively.
FINANCIAL GUIDANCE ImmunoGen’s financial guidance for
2022 remains unchanged; the Company continues to expect:
- 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 reflect 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, please register here. A dial-in and
unique PIN will be provided to join the call. 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. 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 outcome of the FDA’s review of the
Company’s BLA for mirvetuximab, the commercial launch of
mirvetuximab, the enrollment of patients in Trial 0420, the
GLORIOSA Phase 3 trial, and the expansion cohorts combining
pivekimab, azacitidine, and venetoclax in frontline and relapsed
AML, the completion of the dose-escalation Phase 1 study evaluating
IMGC936 and the dosing 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 additional data from the
mirvetuximab program, pivekimab efficacy data for genetic sub-types
of AML, top-line data for the MIRASOL study, top-line data from the
CADENZA study, initial data from the frontline and relapsed AML
expansion cohorts, and initial data from the Phase 1
dose-escalation study evaluating IMGC936; 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 February
28, 2022, 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)
June 30,
December 31,
2022
2021
ASSETS Cash and cash equivalents $
373,874
$
478,750
Other assets
48,421
47,015
Total assets $
422,295
$
525,765
LIABILITIES AND SHAREHOLDERS' EQUITY Current portion
of deferred revenue $
15,636
$
44,351
Other current liabilities
71,435
56,594
Long-term portion of deferred revenue
43,611
47,717
Other long-term liabilities
41,782
51,517
Shareholders' equity
249,831
325,586
Total liabilities and shareholders' equity $
422,295
$
525,765
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (Unaudited)
Three Months Ended
Six Months Ended
June 30,
June 30,
2022
2021
2022
2021
Revenues: License and milestone fees $
6,973
$
252
$
37,865
$
409
Non-cash royalty revenue
7,116
16,690
13,544
32,235
Research and development support
73
6
831
10
Total revenues
14,162
16,948
52,240
32,654
Expenses: Research and development
51,422
34,589
95,704
69,002
Selling, general and administrative
23,793
9,728
40,441
19,937
Total operating expenses
75,215
44,317
136,145
88,939
Loss from operations
(61,053
)
(27,369
)
(83,905
)
(56,285
)
Non-cash interest expense on liability related to sale of
future royalty & convertible bonds
(1,078
)
(3,557
)
(2,327
)
(8,201
)
Interest expense on convertible bonds
-
(23
)
-
(47
)
Other income (loss), net
110
208
66
(259
)
Net loss $
(62,021
)
$
(30,741
)
$
(86,166
)
$
(64,792
)
Basic and diluted net loss per common share $
(0.24
)
$
(0.15
)
$
(0.34
)
$
(0.32
)
Basic and diluted weighted average common shares
outstanding
253,336
199,890
253,263
199,365
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220729005054/en/
INVESTOR RELATIONS CONTACT ImmunoGen Anabel Chan
781-895-0600 anabel.chan@immunogen.com
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
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