Full Mirvetuximab Soravtansine Phase 3 FORWARD I and Initial
Phase 1b FORWARD II Triplet Data Presented at ESMO
Phase 3 MIRASOL Trial for Mirvetuximab in Ovarian Cancer on
Track to Start by Year-End
Updated IMGN632 AML and BPDCN Monotherapy Data Accepted as Oral
Presentation at ASH
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 September 30, 2019.
“The FORWARD I analyses presented at ESMO have provided us with
valuable insights into the patients who benefit most from
mirvetuximab,” said Mark Enyedy, ImmunoGen’s President and Chief
Executive Officer. “We have since met with FDA to review these data
and the design of MIRASOL, the Phase 3 study of mirvetuximab for
platinum-resistant ovarian cancer patients whose tumors express
high levels of folate receptor alpha. We anticipate enrolling our
first patient before year-end and, on the strength of the data we
have generated in the program, believe we have increased the
likelihood of a positive outcome with this next study.”
Enyedy added, “IMGN632 continues to make encouraging progress in
the clinic, with the initiation of combination studies in
relapsed/refractory AML patients and monotherapy expansion into
relapsed ALL and MRD+ AML patients following frontline induction
therapy. We exit the year with significant momentum across our
portfolio with an oral presentation for IMGN632 at ASH, ongoing
studies for mirvetuximab combination regimens, advances in our
early-stage pipeline, and a strong financial position to execute
against our strategic priorities.”
RECENT PROGRESS
- Presented full data and additional exploratory analyses from
the Phase 3 FORWARD I study evaluating mirvetuximab compared to
chemotherapy in women with folate receptor alpha (FRα)-positive,
platinum-resistant ovarian cancer at the European Society for
Medical Oncology (ESMO) Congress.
- Presented initial safety and overall response data from the
Phase 1b FORWARD II triplet cohort evaluating mirvetuximab in
combination with carboplatin and Avastin® (bevacizumab) in patients
with recurrent, platinum-sensitive ovarian cancer at ESMO.
- Met with the United States Food and Drug Administration (FDA)
to review the design of MIRASOL, the Phase 3 study evaluating
mirvetuximab as monotherapy for women with FRα-high,
platinum-resistant ovarian cancer.
- Completed enrollment in the FORWARD II mirvetuximab plus
bevacizumab combination cohort in “platinum agnostic” ovarian
cancer patients for whom a non-platinum-based regimen would be an
appropriate next therapy.
- For IMGN632 monotherapy, continued enrollment in the Phase 1
expansion cohorts in patients with acute myeloid leukemia (AML) and
blastic plasmacytoid dendritic cell neoplasm (BPDCN), opened an
expansion cohort now enrolling patients with relapsed acute
lymphocytic leukemia (ALL), and initiated a study in minimal
residual disease positive (MRD+) AML patients following frontline
induction therapy.
- For IMGN632 combination therapy, initiated studies with Vidaza®
(azacitidine) and Venclexta® (venetoclax) in relapsed/refractory
unfit AML patients.
- Advanced investigational new drug (IND)-enabling activities for
IMGC936, a novel ADAM9-targeting ADC in co-development with
MacroGenics.
ANTICIPATED UPCOMING EVENTS
- Initiate MIRASOL by year-end.
- Present preclinical combination data (poster presentation) and
updated clinical monotherapy data (oral presentation) for IMGN632
with additional patients enrolled in AML and BPDCN expansion
cohorts at the American Society of Hematology (ASH) Annual Meeting
in December.
- Continue enrollment in IMGN632 combination and single-agent
BPDCN, relapsed AML, MRD+ AML, and relapsed ALL expansion
cohorts.
- IND filing for IMGC936 in the first half of 2020.
- Present initial data from FORWARD II platinum agnostic and
updated triplet combination studies in mid-2020.
- Transition next generation anti-FRα ADC, IMGN151, to
pre-clinical development in mid-2020.
FINANCIAL RESULTS Revenues for the quarter ended
September 30, 2019 were $13.3 million, compared with $10.9 million
for the quarter ended September 30, 2018. Revenues in the third
quarter of 2019 included $13.2 million in non-cash royalty
revenues, compared with $8.4 million for the third quarter of 2018.
Revenues for the prior year period also included $0.7 million of
license and milestone fees, inclusive of a $0.5 million milestone
pursuant to a license agreement with Fusion Pharmaceuticals, $0.4
million of research and development (R&D) support fees, and
$1.4 million of clinical materials revenue, compared with $0.1
million of similar fees earned in the current period.
Operating expenses for the third quarter of 2019 were $31.2
million, compared with $56.5 million for the same quarter in 2018.
The decrease was driven by R&D expenses, which were $21.0
million in the third quarter of 2019 compared with $47.2 million
for the third quarter of 2018. 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 and third-party research expenses and lower
facility-related allocations; a decrease in clinical trial expenses
in the current period driven by greater activity in the FORWARD I
Phase 3 clinical trial during the prior year period; and lower
external manufacturing costs driven by activity to support
commercial validation of mirvetuximab in the prior year period.
General and administrative expenses in the third quarter of 2019
were $9.2 million, compared to $8.3 million in the third quarter of
2018, primarily due to a higher allocation of facility-related
expenses for excess laboratory and office space resulting from the
recent restructuring. Operating expenses for the third quarter of
2019 also included a $1.0 million charge related primarily to
retention costs resulting from the restructuring, compared to a
$0.9 million charge recorded in the third quarter of 2018 related
to the decommissioning of the Company’s Norwood facility.
ImmunoGen reported a net loss of $21.8 million, or $0.15 per
basic and diluted share, for the third quarter of 2019, compared
with a net loss of $46.8 million, or $0.32 per basic and diluted
share, for the same quarter last year. Weighted average shares
outstanding increased to 148.5 million from 147.2 million in those
quarters.
ImmunoGen had $204.5 million in cash and cash equivalents as of
September 30, 2019, compared with $262.3 million as of December 31,
2018, and had $2.1 million of convertible debt outstanding in each
period. Cash used in operations was $55.8 million for the first
nine months of 2019, compared with cash used in operations of
$125.1 million for the same period in 2018. The current 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. Capital expenditures were $2.8
million and $4.2 million for the first nine months of 2019 and
2018, respectively.
FINANCIAL GUIDANCE ImmunoGen has updated its financial
guidance for 2019 as follows:
- revenues between $65 million and $70 million;
- operating expenses between $170 million and $175 million;
and
- cash and cash equivalents at December 31, 2019, between $170
million and $175 million.
Revenue guidance has been updated to reflect recognition of
deferred revenue under our Jazz Pharmaceuticals collaboration
related to IMGN779, which was discontinued as part of ImmunoGen’s
portfolio prioritization exercise in June of this year. ImmunoGen
expects that its current cash, together with expense reductions
resulting from the operational changes previously announced and
anticipated cash receipts from partners, will fund operations
through the release of top-line results from MIRASOL, which are
expected in the first 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 8865657. 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: the Company’s revenues and
operating expenses for the twelve months ending December 31, 2019;
its cash and marketable securities as of December 31, 2019; the
occurrence, timing, and outcome of potential pre-clinical,
clinical, and regulatory events related to the Company’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 the Company’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;
and other factors more fully described in ImmunoGen’s Annual Report
on Form 10-K for the year ended December 31, 2018 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)
September 30, December 31,
2019
2018
ASSETS Cash and cash equivalents
$
204,491
$
262,252
Other assets
49,645
33,129
Total assets
$
254,136
$
295,381
LIABILITIES AND SHAREHOLDERS' (DEFICIT) EQUITY
Current portion of deferred revenue
$
14,817
$
317
Other current liabilities
73,357
70,343
Long-term portion of deferred revenue
131,035
80,485
Other long-term liabilities
121,152
133,264
Shareholders' (deficit) equity
(86,225
)
10,972
Total liabilities and shareholders' (deficit) equity
$
254,136
$
295,381
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (Unaudited) Three Months Ended Nine
Months Ended September 30, September 30,
2019
2018
2019
2018
Revenues: Non-cash royalty revenue
$
13,202
$
8,441
$
32,102
$
22,873
License and milestone fees
79
672
5,237
13,533
Research and development support
-
388
68
1,159
Clinical materials revenue
-
1,427
-
2,465
Total revenues
13,281
10,928
37,407
40,030
Expenses: Research and development
21,015
47,243
88,467
130,775
General and administrative
9,208
8,347
28,686
26,994
Restructuring charge
1,020
870
20,921
3,287
Total operating expenses
31,243
56,460
138,074
161,056
Loss from operations
(17,962
)
(45,532
)
(100,667
)
(121,026
)
Non-cash interest expense on liability related to sale of
future royalty & convertible bonds
(4,275
)
(2,546
)
(11,525
)
(8,203
)
Interest expense on convertible bonds
(24
)
(23
)
(71
)
(70
)
Other income (loss), net
511
1,294
3,316
2,255
Net loss
$
(21,750
)
$
(46,807
)
$
(108,947
)
$
(127,044
)
Basic and diluted net loss per common share
$
(0.15
)
$
(0.32
)
$
(0.74
)
$
(0.92
)
Basic and diluted weighted average common shares
outstanding
148,479
147,220
148,143
137,472
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191101005080/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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