Submitted BLA for Mirvetuximab Soravtansine Monotherapy to FDA
Under Accelerated Approval Pathway; Commercial Preparations
Underway
Presented Results from Positive Pivotal SORAYA Trial of
Mirvetuximab Soravtansine in Ovarian Cancer in Plenary Session at
SGO Annual Meeting; Additional Efficacy and Safety Data to be
Highlighted at ASCO
Top-Line Data from Confirmatory MIRASOL Trial Now Expected in
Early 2023 Based on Recent Reforecast of Projected PFS Events
Progressing Second Pivotal Program, Pivekimab Sunirine, with
Top-Line Data in BPDCN Anticipated Before Year-End; Enrollment
Ongoing in Phase 1b/2 Expansion Triplet Cohorts in AML
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 March 31, 2022.
“Following the presentation of the results from our positive
pivotal SORAYA trial at SGO, we were pleased to submit the BLA to
support the accelerated approval of mirvetuximab monotherapy in
FRα-high platinum-resistant ovarian cancer. We requested Priority
Review for the BLA and look forward to acceptance towards the end
of May and a PDUFA date on the application later this year,” said
Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. “In
preparation for potential commercialization, we have significantly
ramped our launch readiness activities, with a focus on increasing
mirvetuximab and FRα awareness among prescribers.”
Enyedy continued, “The broader mirvetuximab program is also
advancing nicely, with accrual accelerating in MIRASOL following
the release of the SORAYA results in late November, enrollment
continuing in PICCOLO, and initiation of our GLORIOSA and Trial
0420 combination studies anticipated by mid-year. Based upon a
reforecast generated in conjunction with the recent pre-specified
interim futility analysis for MIRASOL, we now expect to reach the
requisite number of PFS events in the fourth quarter and will
report top-line data from MIRASOL in early 2023. Turning to our
second pivotal program, pivekimab, with the recommended phase 2
dose for the triplet in combination with azacitidine and venetoclax
determined, we have moved forward with expansion cohorts in both
frontline and relapsed AML patients and are on track to report
preliminary efficacy data from our pivotal CADENZA study in BPDCN
before year-end. Regarding our earlier-stage programs,
dose-escalation continues in the Phase 1 trial of IMGC936 in
multiple solid tumors and the activities to generate the CMC
information needed for our IND for IMGN151 are on track. With a
strong start and intense focus on execution, we are well positioned
to deliver on our near-term objectives and transform ImmunoGen into
a fully-integrated oncology company this year.”
RECENT PROGRESS
- Submitted the biologics license application (BLA) under the
accelerated approval pathway to the US Food and Drug Administration
(FDA) for mirvetuximab soravtansine (mirvetuximab) monotherapy in
patients with folate receptor alpha (FRα)-high platinum-resistant
ovarian cancer who have been previously treated with 1 to 3 prior
systemic treatments.
- Presented results from the pivotal SORAYA trial of
mirvetuximab, demonstrating impressive anti-tumor activity and
durability of response, together with a differentiated safety
profile, at the Society of Gynecologic Oncology (SGO) 2022 Annual
Meeting.
- Continued enrollment in the confirmatory MIRASOL study and
recently completed a pre-specified interim futility analysis with a
recommendation from the Independent Data Monitoring Committee for
MIRASOL to proceed without modification.
- 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, formerly IMGN632) in frontline and
relapsed/refractory (R/R) blastic plasmacytoid dendritic cell
neoplasm (BPDCN).
- Initiated expansion cohorts in the Phase 1b/2 study evaluating
pivekimab, Vidaza® (azacitidine), and Venclexta® (venetoclax) in
both relapsed 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 to the FDA to support
the investigational new drug (IND) application for IMGN151.
- 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 in exchange for up to
$1.7 billion in potential exercise fees and milestone
payments.
ANTICIPATED UPCOMING EVENTS
- Potential for BLA acceptance by FDA under the accelerated
approval pathway for mirvetuximab as a monotherapy in patients with
FRα-high platinum-resistant ovarian cancer who have been previously
treated with 1 to 3 prior systemic treatments.
- Present additional efficacy and safety analyses from the
mirvetuximab program at the American Society of Clinical Oncology
(ASCO) Annual Meeting in June.
- Generate top-line data for MIRASOL in early 2023.
- Initiate two combination studies for mirvetuximab in
platinum-sensitive ovarian cancer by mid-2022: 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 Avastin® (bevacizumab)
maintenance in FRα-high patients.
- Report preliminary efficacy data from the pivotal CADENZA study
of pivekimab in BPDCN before year-end.
- Present initial data from frontline and relapsed 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 $38.1 million for the quarter ended March
31, 2022 compared to $15.7 million for the quarter ended March 31,
2021. The increase was driven by the recognition of $21.6 million
of fees previously received and deferred pursuant to the Company’s
collaboration agreement with Huadong Medicine and the recognition
of $9.2 million of a $13.0 million upfront payment received
pursuant to the Company’s license agreement with Lilly in the first
quarter of 2022. Partially offsetting these increases, non-cash
royalty revenue decreased $9.1 million due to the completion of the
first tranche of payments under the 2015 KADCYLA® royalty agreement
in the second quarter of 2021.
Operating expenses for the quarter ended March 31, 2022 were
$60.9 million, compared with $44.6 million for the same quarter in
2021. Research and development expenses rose to $44.3 million for
the quarter ended March 31, 2022 compared to $34.4 million for the
quarter ended March 31, 2021, driven by increases in personnel and
temporary staffing costs, regulatory filing fees, third-party
service fees, and external manufacturing costs in support of
commercial readiness. Selling, general and administrative expenses
increased to $16.6 million for the quarter ended March 31, 2022
compared to $10.2 million for the quarter ended March 31, 2021, due
primarily to building commercial capabilities, including the hiring
of personnel, in anticipation of a potential US launch of
mirvetuximab in the second half of 2022.
Net loss for the first quarter of 2022 was $24.1 million, or
$0.10 per basic and diluted share, compared to a net loss of $34.1
million, or $0.17 per basic and diluted share, for the first
quarter of 2021. Weighted average shares outstanding increased to
253.3 million for the 2022 period from 198.8 million in the prior
year.
ImmunoGen had $437.7 million in cash and cash equivalents as of
March 31, 2022, compared with $478.8 million as of December 31,
2021. Cash used in operations was $41.4 million for the first three
months of 2022, compared with cash used in operations of $44.6
million for the same period in 2021, with the current period
benefitting from a $13.0 million upfront license payment received
from Lilly. Capital expenditures were $0.3 million and $0.9 million
for the first three 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 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 5444669. 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
accelerated approval of the Company’s BLA to the FDA for
mirvetuximab, the 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 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 safety and
efficacy data from SORAYA, 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 is not
complete and acceptable for filing or 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) March
31, December 31,
2022
2021
ASSETS Cash and cash equivalents $
437,661
$
478,750
Other assets
44,048
47,015
Total assets $
481,709
$
525,765
LIABILITIES AND SHAREHOLDERS' EQUITY Current portion
of deferred revenue $
23,417
$
44,351
Other current liabilities
60,701
56,594
Long-term portion of deferred revenue
46,694
47,717
Other long-term liabilities
44,429
51,517
Shareholders' equity
306,468
325,586
Total liabilities and shareholders' equity $
481,709
$
525,765
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (Unaudited) Three Months Ended
March 31,
2022
2021
Revenues: License and milestone fees $
30,892
$
157
Non-cash royalty revenue
6,428
15,545
Research and development support
758
4
Total revenues
38,078
15,706
Expenses: Research and development
44,282
34,413
Selling, general and administrative
16,648
10,209
Total operating expenses
60,930
44,622
Loss from operations
(22,852
)
(28,916
)
Non-cash interest expense on liability related to sale of
future royalty & convertible bonds
(1,249
)
(4,644
)
Interest expense on convertible bonds
-
(24
)
Other loss, net
(44
)
(467
)
Net loss $
(24,145
)
$
(34,051
)
Basic and diluted net loss per common share $
(0.10
)
$
(0.17
)
Basic and diluted weighted average common shares
outstanding
253,263
198,835
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version on businesswire.com: https://www.businesswire.com/news/home/20220506005068/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
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