Encouraging Data from FORWARD II Study of Mirvetuximab in
Combination with Avastin® in Recurrent Ovarian Cancer, Regardless
of Platinum Status, Presented at ASCO
Preclinical Data on Next Generation Anti-FRα ADC, IMGN151,
Demonstrating Enhanced Anti-Tumor Activity, Presented at AACR
Positive Opinion on Orphan Drug Designation for IMGN632 for
Treatment of BPDCN Adopted by EMA’s COMP
IND Application for Novel ADAM9-Targeting ADC, IMGC936, Accepted
by FDA
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, 2020.
“Despite the challenges of operating in a fully remote
environment due to the pandemic, our performance in the second
quarter was marked by sound execution and important data
presentations and regulatory milestones,” said Mark Enyedy,
ImmunoGen’s President and Chief Executive Officer. “In an oral
presentation at ASCO, we shared data demonstrating the potential of
mirvetuximab to serve as the combination agent of choice with
Avastin in recurrent ovarian cancer, with an overall response rate
in the platinum-resistant subset more than twice the response rate
observed with Avastin plus chemotherapy combinations in this
population and, in the platinum-sensitive subset, an overall
response rate higher than previously seen with platinum-based
doublets. We also presented preclinical data at AACR for IMGN151
that support development of this next generation ADC in a wide
array of FRα-positive tumor types. On the regulatory front, we were
pleased that EMA’s Committee for Orphan Medicinal Products adopted
a positive opinion to grant IMGN632 orphan drug designation for the
treatment of BPDCN and that FDA accepted the IND application for
IMGC936. Further, we strengthened our management team by welcoming
Stacy Coen as our Chief Business Officer and Susan Altschuller, PhD
as our Chief Financial Officer.”
Enyedy continued, “While we have maintained a high level of
productivity over the last quarter, the impact of COVID-19 has
slowed site activation and patient enrollment for SORAYA, which we
believe will result in a limited delay of six- to eight-weeks in
the readout of topline data. With conditions improving in Europe,
we expect to accelerate both SORAYA and MIRASOL over the remainder
of 2020 and continue to anticipate the BLA for mirvetuximab in the
second half of 2021. We also look forward to advancing our
monotherapy and combination cohorts for IMGN632 and initiating the
Phase 1 study of IMGC936 in partnership with MacroGenics. Finally,
we will provide mature data from our triplet cohort evaluating
mirvetuximab in combination with carboplatin and Avastin in
patients with recurrent, platinum-sensitive ovarian cancer at ESMO
in September and an update on our progress with IMGN632 at ASH in
December.”
RECENT PROGRESS
- Presented data from the FORWARD II study evaluating
mirvetuximab in combination with Avastin (bevacizumab) in recurrent
ovarian cancer, regardless of platinum status, in an oral
presentation at the virtual American Society of Clinical Oncology
(ASCO) Annual Meeting.
- Continued site activation and patient enrollment in the pivotal
SORAYA and confirmatory MIRASOL trials, with sites opening in
multiple countries in Europe during the quarter.
- Received positive opinion from the European Medicines Agency’s
(EMA) Committee for Orphan Medicinal Products (COMP) to grant
IMGN632 orphan drug designation for the treatment of blastic
plasmacytoid dendritic cell neoplasm (BPDCN).
- Advanced multiple cohorts with IMGN632, including monotherapy
expansion in BPDCN and minimal residual disease positive (MRD+)
acute myeloid leukemia (AML) following frontline induction therapy
and combinations with Vidaza® (azacitidine) and Venclexta®
(venetoclax) in relapsed/refractory AML patients.
- Received acceptance for an investigational new drug (IND)
application for IMGC936, a novel ADAM9-targeting ADC being
co-developed with MacroGenics, from the US Food and Drug
Administration (FDA).
- Presented compelling preclinical 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.
- Transitioned IMGN151 into preclinical development.
- Appointed Stacy Coen as Chief Business Officer and Susan
Altschuller, PhD as Chief Financial Officer.
ANTICIPATED UPCOMING EVENTS
- Present mature data from the FORWARD II platinum-sensitive
triplet cohort evaluating mirvetuximab in combination with
carboplatin and bevacizumab at the European Society for Medical
Oncology (ESMO) Congress in September.
- Support initiation of an investigator sponsored, randomized
trial comparing mirvetuximab plus carboplatin versus standard
platinum-based therapy in recurrent platinum-sensitive ovarian
cancer in the fourth quarter.
- Present updated data from the IMGN632 monotherapy BPDCN
expansion and progress on the AML monotherapy and combination
cohorts at the American Society of Hematology (ASH) Annual Meeting
in December.
- Initiate Phase 1 trial for IMGC936 in ADAM-9 positive solid
tumors including non-small cell lung, pancreatic, gastric, and
triple negative breast cancer in the fourth quarter.
FINANCIAL RESULTS
Revenues for the quarter ended June 30, 2020 were $15.0 million,
compared with $15.5 million for the quarter ended June 30, 2019.
Revenues in the second quarter of 2020 included $14.1 million in
non-cash royalty revenues, compared with $10.4 million for the
second quarter of 2019. License and milestone fees of $5.1 million
for the second quarter of 2019 included recognition and receipt of
a $5 million partner milestone, compared to $0.9 million of upfront
license fees recognized in the second quarter of 2020.
Operating expenses for the second quarter of 2020 were $33.4
million, compared with $56.6 million for the same quarter in 2019.
The decrease was primarily driven by a $19.3 million restructuring
charge recorded in the prior period. Operating expenses for the
current period included a $0.7 million restructuring charge related
to retention costs. R&D expenses were $22.9 million in the
second quarter of 2020, compared with $28.6 million for the second
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 second quarter of 2020 increased to $9.8 million
compared to $8.7 million for the second quarter of 2019, primarily
due to increased professional fees and a higher allocation of
facility-related expenses for excess laboratory and office space,
partially offset by lower personnel expenses.
Net loss for the second quarter of 2020 was $24.3 million, or
$0.14 per basic and diluted share, compared to a net loss of $43.4
million, or $0.29 per basic and diluted share, for the second
quarter of 2019. Weighted average shares outstanding increased to
174.4 million from 148.1 million in the prior year.
ImmunoGen had $219.5 million in cash and cash equivalents as of
June 30, 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 $56.5 million for the first six
months of 2020, compared with cash used in operations of $20.8
million for the same period in 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
emtansine) royalties in January 2019. Net proceeds from the sale of
equipment were $1.4 million for the first six months of 2020
compared with capital expenditures of $(2.4) million for the same
period in 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 is preparing for potential accelerated approval for
mirvetuximab in platinum-resistant ovarian cancer and is planning
for increased investment in 2021 related to manufacturing in
support of commercial launch. With the addition of these
investments, the Company expects that its current cash and
anticipated cash receipts from partners will fund operations into
the second 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 4388395. 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; the length of time that
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)
June 30,
December 31,
2020
2019
ASSETS Cash and cash equivalents $
219,506
$
176,225
Other assets
50,222
59,037
Total assets $
269,728
$
235,262
LIABILITIES AND SHAREHOLDERS' DEFICIT Current portion
of deferred revenue $
80
$
309
Other current liabilities
90,799
77,101
Long-term portion of deferred revenue
126,535
127,123
Other long-term liabilities
76,837
106,850
Shareholders' deficit
(24,523
)
(76,121
)
Total liabilities and shareholders' deficit $
269,728
$
235,262
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (Unaudited)
Three Months Ended
Six Months Ended
June 30,
June 30,
2020
2019
2020
2019
Revenues: Non-cash royalty revenue $
14,075
$
10,412
$
27,072
$
18,900
License and milestone fees
945
5,079
1,228
5,158
Research and development support
5
51
12
68
Total revenues
15,025
15,542
28,312
24,126
Expenses: Research and development
22,921
28,559
50,329
67,452
General and administrative
9,767
8,700
18,631
19,478
Restructuring charge
699
19,342
1,524
19,901
Total operating expenses
33,387
56,601
70,484
106,831
Loss from operations
(18,362
)
(41,059
)
(42,172
)
(82,705
)
Non-cash interest expense on liability related to sale of
future royalty & convertible bonds
(6,081
)
(3,818
)
(11,783
)
(7,250
)
Interest expense on convertible bonds
(23
)
(23
)
(47
)
(47
)
Other income, net
168
1,454
616
2,805
Net loss $
(24,298
)
$
(43,446
)
$
(53,386
)
$
(87,197
)
Basic and diluted net loss per common share $
(0.14
)
$
(0.29
)
$
(0.31
)
$
(0.59
)
Basic and diluted weighted average common shares
outstanding
174,354
148,129
171,055
147,972
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version on businesswire.com: https://www.businesswire.com/news/home/20200731005080/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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