Pivotal SORAYA Trial Initiated for Mirvetuximab Soravtansine in
Platinum-Resistant Ovarian Cancer
Data from FORWARD II Avastin® Expansion Cohort in
Platinum-Agnostic Ovarian Cancer Selected for Oral Presentation at
ASCO
Pre-Clinical Data on Next Generation Anti-FRα ADC to be
Presented at AACR
Operational Plans Remain on Track amid COVID-19 Pandemic
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, 2020.
“During the last quarter, we moved forward with our registration
studies for mirvetuximab and advanced our portfolio of
earlier-stage candidates, while adapting to meet the evolving
challenges of the COVID-19 pandemic,” said Mark Enyedy, ImmunoGen’s
President and Chief Executive Officer. “Our lead program remains on
track with the initiation of our pivotal SORAYA trial and patient
enrollment in our confirmatory MIRASOL trial progressing as
anticipated. In parallel, we continue to follow our FORWARD II
combination cohorts and we are pleased to have initial data from
our Avastin expansion cohort in platinum-agnostic ovarian cancer
selected for a virtual oral presentation at ASCO in May.
IND-enabling activities for IMGC936, our novel ADAM9-targeting ADC,
continue on plan with an IND submission anticipated by the end of
this quarter and we look forward to presenting pre-clinical data on
IMGN151, our next generation anti-FRα ADC being investigated in
tumors with a broad range of FRα expression, at the virtual AACR
Annual Meeting in June.”
Enyedy added, “Having generated approximately $98M in net
proceeds through a follow-on offering in January, we are in a
strong financial position with our anticipated cash runway extended
well into 2022. Drawing on the organizational resilience built over
the last year, our team has risen to the challenge of COVID-19 to
ensure that we can meet the needs of our patients around the globe.
We have put in place business continuity plans to allow us to
operate effectively in a virtual working environment, actively
monitor our progress in our key studies, and rapidly adapt in
response to new developments. Through these efforts, we seek to
maintain the momentum we have generated in the business throughout
2020.”
RECENT PROGRESS
- Initiated SORAYA, a new single-arm study in platinum-resistant
ovarian cancer for women previously treated with Avastin®
(bevacizumab), which is designed to support accelerated approval
for mirvetuximab.
- Continued to open sites and enroll patients in confirmatory
Phase 3 MIRASOL trial.
- Advanced multiple cohorts with IMGN632, including monotherapy
expansion in blastic plasmacytoid dendritic cell neoplasm (BPDCN)
and minimal residual disease positive (MRD+) acute myeloid
leukemeia (AML) following frontline induction therapy and
combinations with Vidaza® (azacitidine) and Venclexta® (venetoclax)
in relapsed/refractory AML patients.
- Progressed investigational new drug (IND)-enabling activities
for IMGC936, a novel ADAM9-targeting ADC in co-development with
MacroGenics.
- Raised $97.7 million in net proceeds in a follow-on offering in
January.
- Activated business continuity plans in the context of
COVID-19.
ANTICIPATED UPCOMING EVENTS
- Continue patient enrollment in pivotal SORAYA and confirmatory
MIRASOL trials.
- Support initiation of an additional platinum-sensitive
investigator sponsored trial evaluating mirvetuximab in combination
with carboplatin in over 100 patients.
- Present initial data from the FORWARD II platinum-agnostic
doublet cohort evaluating mirvetuximab in combination with
bevacizumab in an oral presentation at the virtual American Society
of Clinical Oncology (ASCO) Annual Meeting in May.
- Present pre-clinical data evaluating our next generation
anti-folate receptor alpha (FRα) ADC, IMGN151, in ovarian cancer
and other tumor types in a poster at the virtual American
Association for Cancer Research (AACR) Annual Meeting in June.
- Present updated data from the FORWARD II platinum-sensitive
triplet cohort evaluating mirvetuximab in combination with
carboplatin and bevacizumab in the fall.
- Continue enrollment in IMGN632 monotherapy and combination
cohorts.
- File IND for IMGC936 at the end of Q2.
- Transition IMGN151 into pre-clinical development.
FINANCIAL RESULTS
Revenues for the quarter ended March 31, 2020 were $13.3
million, compared with $8.6 million for the quarter ended March 31,
2019, which consisted primarily of non-cash royalty revenues.
Operating expenses for the first quarter of 2020 were $37.1
million, compared with $50.2 million for the same quarter in 2019.
The decrease was driven by R&D expenses, which were $27.4
million for the first quarter of 2020 compared with $38.9 million
for the first quarter of 2019. This decrease was primarily due to
lower expenses resulting from the restructuring of the business at
the end of the second quarter of 2019, including decreases in
personnel, facility, and third-party research expenses. Partially
offsetting these decreases, clinical trial expenses increased in
the current quarter driven by costs related to the Company’s
MIRASOL, SORAYA, and IMGN632 combination therapy studies. General
and administrative expenses for the first quarter of 2020 decreased
to $8.9 million compared to $10.8 million for the first quarter of
2019 primarily due to lower personnel expenses resulting from the
restructuring, partially offset by a higher allocation of
facility-related expenses for excess laboratory and office space.
Operating expenses for the first quarter of 2020 also included a
$0.8 million restructuring charge related to retention costs,
compared to a $0.6 million charge recorded in the first quarter of
2019 related to a loss recorded on leased office space.
Net loss for the first quarter of 2020 was $29.1 million, or
$0.17 per basic and diluted share, compared to a net loss of $43.8
million, or $0.30 per basic and diluted share, for the first
quarter of 2019. Weighted average shares outstanding increased to
166.9 million from 147.8 million in the prior year.
In January 2020, pursuant to a public offering, the Company sold
an aggregate of 24.5 million shares of its common stock, with net
proceeds to the Company of $97.7 million, after deducting
underwriting discounts and offering expenses.
ImmunoGen had $247.3 million in cash and cash equivalents as of
March 31, 2020, compared with $176.2 million as of December 31,
2019, and had $2.1 million of convertible debt outstanding in each
period. Cash used in operations was $(28.3) million for the quarter
ended March 31, 2020, compared with cash provided by operations of
$10.2 million for the quarter ended March 31, 2019. The prior year
period benefited from $65.2 million of net proceeds generated from
the sale of the Company’s residual rights to Kadcyla®
(ado-trastuzumab emtasine) royalties in January 2019. Net proceeds
from the sale of equipment were $1.4 million for the first quarter
of 2020 compared with capital expenditures of $(2.1) million for
the first quarter of 2019.
FINANCIAL GUIDANCE
ImmunoGen’s financial guidance for 2020 remains unchanged:
- revenues between $60 million and $65 million;
- operating expenses between $165 million and $170 million;
and
- cash and cash equivalents at December 31, 2020 to be between
$170 million and $175 million.
ImmunoGen expects that its current cash and anticipated cash
receipts from partners 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 7796220. The call may also be
accessed through the Investors and Media section of 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 based on
management's current expectations. These statements include, but
are not limited to, ImmunoGen’s expectations related to:
ImmunoGen’s revenues and operating expenses for the twelve months
ending December 31, 2020; ImmunoGen’s cash and marketable
securities as of December 31, 2020; how long ImmunoGen’s cash and
anticipated cash receipts from partners will fund operations; the
occurrence, timing, and outcome of potential pre-clinical,
clinical, and regulatory events related to ImmunoGen’s product
candidates; and the presentation of pre-clinical 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 ImmunoGen’s clinical development processes; the
difficulties inherent in the development of novel pharmaceuticals,
including uncertainties as to the timing, expense, and results of
pre-clinical 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 resulting impact on ImmunoGen’s industry
and business; and other factors more fully described in ImmunoGen’s
Annual Report on Form 10-K for the year ended December 31, 2019 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) March
31, December 31,
2020
2019
ASSETS Cash and cash equivalents
$
247,299
$
176,225
Other assets
51,510
59,037
Total assets
$
298,809
$
235,262
LIABILITIES AND SHAREHOLDERS' DEFICIT Current portion
of deferred revenue
$
123
$
309
Other current liabilities
85,383
77,101
Long-term portion of deferred revenue
127,387
127,123
Other long-term liabilities
90,019
106,850
Shareholders' deficit
(4,103
)
(76,121
)
Total liabilities and shareholders' deficit
$
298,809
$
235,262
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (Unaudited) Three Months Ended
March 31,
2020
2019
Revenues: Non-cash royalty revenue
12,997
8,488
License and milestone fees
$
283
$
79
Research and development support
7
17
Total revenues
13,287
8,584
Expenses: Research and development
27,408
38,893
General and administrative
8,864
10,778
Restructuring charge
825
559
Total operating expenses
37,097
50,230
Loss from operations
(23,810
)
(41,646
)
Non-cash interest expense on liability related to sale of
future royalty & convertible bonds
(5,702
)
(3,432
)
Interest expense on convertible bonds
(24
)
(24
)
Other income, net
448
1,351
Net loss
$
(29,088
)
$
(43,751
)
Basic and diluted net loss per common share
$
(0.17
)
$
(0.30
)
Basic and diluted weighted average common shares
outstanding
166,947
147,813
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version on businesswire.com: https://www.businesswire.com/news/home/20200501005053/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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