Patient Enrollment in FORWARD I Phase 3 Trial
of Mirvetuximab Soravtansine Completed Ahead of Schedule; On Track
for Top-Line Results in the First Half of 2019
Encouraging Data Reported from FORWARD II
Assessment of Mirvetuximab with Keytruda®; Additional Combination
Data to be Presented in 2018, including Mirvetuximab in Combination
with Avastin® at ASCO
IMGN779 and IMGN632 Advancing Through
Dose-Finding Evaluations with Data Expected in the Fourth Quarter;
FDA has Granted Orphan-drug Designation to IMGN779 for the
Treatment of Acute Myeloid Leukemia
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 operating results for
the quarter ended March 31, 2018.
“We have achieved a number of important milestones to start the
year, led by the advancement of mirvetuximab soravtansine,” said
Mark Enyedy, ImmunoGen’s president and chief executive officer.
“Our FORWARD I registration trial continues as planned following
the successful outcome of the pre-specified interim futility
analysis and the completion of enrollment in the trial earlier than
expected. This accelerated accrual reflects the significant
interest expressed by the oncology community in mirvetuximab and
the need for new treatments in platinum-resistant ovarian cancer.
In addition, as we look to expand the eligible patient population
for this program, we were also pleased to report encouraging data
for mirvetuximab in combination with Keytruda from our FORWARD II
trial at SGO in March and look forward to presenting additional
data from FORWARD II during 2018, with a poster presentation at
ASCO for the mirvetuximab and Avastin expansion cohort. Finally,
with our continued evolution towards a commercial-stage company, we
have strengthened our management team with the addition of Blaine
McKee as Chief Business Officer.”
Recent Progress
Mirvetuximab Soravtansine
- In April, ImmunoGen announced the
completion of patient enrollment two months ahead of schedule in
its Phase 3 FORWARD I trial. FORWARD I is designed to support full
approval of mirvetuximab as a single-agent therapy for
platinum-resistant ovarian cancer.
- In April, ImmunoGen successfully
completed a pre-specified interim analysis for futility after 80
progression-free survival (PFS) events in FORWARD I. The study will
continue as planned based on the recommendation of the Independent
Data Monitoring Committee and the Company is on-track to report
top-line results in first half of 2019.
- In March, ImmunoGen presented data from
the dose-escalation FORWARD II cohort evaluating mirvetuximab in
combination with Keytruda (pembrolizumab) at the Society of
Gynecologic Oncology (SGO) Annual Meeting, demonstrating
encouraging efficacy and favorable tolerability in patients with
platinum-resistant ovarian cancer. Notably, in the subset of eight
patients with medium or high levels of folate receptor alpha (FRα)
expression, the confirmed overall response rate (ORR) was 63
percent (95% CI 25, 92), with a median PFS of 8.6 months (95% CI
1.6, upper bound not yet reached), and duration of response of 36.1
weeks. Based on these data, ImmunoGen is enrolling an additional 35
patients with medium or high FRα expression levels in an expansion
cohort in the FORWARD II study and expects to present data from
this cohort later this year.
Early-Stage Pipeline – Novel IGN Compounds
- IMGN779 is a CD33-targeting ADC in a
Phase 1 dose-finding study in relapsed/refractory acute myeloid
leukemia (AML). Dose escalation is continuing with both biweekly
and weekly dosing schedules. The Food and Drug Administration (FDA)
has granted orphan-drug designation to IMGN779 for the treatment of
AML.
- IMGN632 is a CD123-targeting ADC in a
Phase 1 dose-finding study for AML and blastic plasmacytoid
dendritic cell neoplasm (BPDCN).
Research and Innovation
- In April, ImmunoGen presented three
posters at the American Association for Cancer Research (AACR)
Annual Meeting highlighting the Company’s ongoing innovation in
ADCs, including advancements to payloads and targets for enhanced
anti-tumor activity as well as insights into factors that determine
the clinical efficacy of ADCs.
Anticipated Upcoming Events
- Report updated data from the FORWARD II
mirvetuximab plus Avastin (bevacizumab) combination expansion
cohort in approximately 50 patients at the American Society of
Clinical Oncology (ASCO) Annual Meeting;
- Anticipate partner Takeda to begin
clinical testing of TAK-164 in 2Q 2018;
- Report initial findings from the
FORWARD II mirvetuximab plus pembrolizumab combination expansion
cohort in 35 patients in the second half of the year;
- Report additional data from IMGN779
Phase 1 dose finding study in 4Q 2018 and identify the recommended
Phase 2 dose before the end of the year;
- Report initial data from IMGN632 Phase
1 dose finding study in 4Q 2018; and
- Advance ADAM9 program into IND-enabling
activities before year-end.
Financial Results
Revenues for the quarter ended March 31, 2018 were $19.8
million, compared to $28.5 million for the quarter ended March 31,
2017. License and milestone fees of $11.5 million for the first
quarter of 2018 included $10.9 million and $0.5 million of
recognized upfront fees previously received from Takeda and
Debiopharm, respectively, compared to recognition of $12.7 million
of a non-cash fee related to the Company’s license agreement with
CytomX and $6 million in partner milestone payments received in the
first quarter of 2017. Revenues in the first quarter of 2018
included $7.2 million in non-cash royalty revenues, compared with
$7.6 million for the same quarter in 2017, reflecting a change in
accounting standards for recognizing royalty revenue. Revenues for
the first quarter of 2018 also included $0.4 million of research
and development (R&D) support fees and $0.7 million of clinical
materials revenue, compared with $1.5 million and $0.7 million,
respectively, for the same quarter in 2017.
Operating expenses, including R&D and G&A expenses, for
the first quarter of 2018 were $56.6 million, compared to $41.4
million for the same quarter in 2017. R&D expenses for the
first quarter of 2018 increased to $44.8 million, compared to $32.9
million for the first quarter of 2017, primarily due to increased
clinical trial and drug supply costs driven largely by the
accelerated timing of completing patient enrollment in the FORWARD
I Phase 3 clinical trial. General and administrative expenses
increased in the first quarter of 2018 to $10.0 million, compared
to $8.1 million in the same quarter of 2017, primarily due to
increased third-party service fees and stock-based compensation.
Operating expenses for the first quarter of 2018 also included a
$1.7 million restructuring charge due to the workforce reduction
related to the decommissioning of our Norwood facility as
previously announced by the Company, compared to a $0.4 million
charge in the same quarter of 2017 related to losses recorded on
leased office space in Waltham.
ImmunoGen reported a net loss of $38.6 million, or $0.30 per
basic and diluted share, for the first quarter of 2018, compared to
a net loss of $17.3 million, or $0.20 per basic and diluted share,
for the same quarter last year.
ImmunoGen had $218.4 million in cash and cash equivalents as of
March 31, 2018, compared with $267.1 million as of December 31,
2017, and had $2.1 million of convertible debt outstanding in each
period. Cash used in operations was $50.0 million for the first
quarter of 2018, compared with $33.0 million for the first quarter
of 2017. Capital expenditures were $1.0 million and $0.4 million
for the first quarter of 2018 and 2017, respectively.
Financial Guidance
ImmunoGen has updated its operating expenses guidance for 2018.
ImmunoGen now expects:
- operating expenses between
$200 million and $205 million.
Guidance for revenues and cash remains unchanged:
- revenues between $60 million and
$65 million; and
- cash and cash equivalents at December
31, 2018 between $115 million and $120 million.
ImmunoGen expects that its current cash combined with the
expected cash revenues from partners and collaborators will enable
the Company to fund its operations into the fourth quarter of
2019.
Conference Call InformationImmunoGen will hold a
conference call today at 8:00 am ET to discuss these results. To
access the live call by phone, dial 719-325-4799; the conference ID
is 2070974. The call may also be accessed through the Investors
section of the Company’s website, www.immunogen.com. Following the
live webcast, a replay of the call will be available at the same
location through May 18, 2018.
About ImmunoGen, Inc.ImmunoGen is a clinical-stage
biotechnology company that develops targeted cancer therapeutics
using its proprietary ADC technology. The Company’s lead product
candidate, mirvetuximab soravtansine, is in the Phase 3 FORWARD I
trial for FRα-positive platinum-resistant ovarian cancer, and is in
the Phase 1b/2 FORWARD II trial in combination regimens for
earlier-stage disease. ImmunoGen has three additional
clinical-stage product candidates, two of which are being developed
in collaboration with Jazz Pharmaceuticals. ImmunoGen's ADC
technology is also used in Roche's marketed product, Kadcyla®, and
in programs in development by Amgen, Bayer, Biotest, CytomX,
Debiopharm, Lilly, Novartis, Sanofi and Takeda. More information
about the Company can be found at www.immunogen.com.
Keytruda®, Avastin®, and Kadcyla® are registered trademarks of
their respective owners.
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, operating expenses, net loss, cash used in
operations and capital expenditures for the twelve months ending
December 31, 2018; its cash and marketable securities as of
December 31, 2018; the occurrence, timing and outcome of potential
pre-clinical, clinical and regulatory events related to the
Company's and its collaboration partners' product programs; and the
presentation of preclinical and clinical data on the Company’s and
collaboration partners’ 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 and the Company's collaboration partners'
research 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; ImmunoGen's
ability to financially support its product programs; ImmunoGen's
dependence on collaborative partners; industry merger and
acquisition activity; and other factors more fully described in
ImmunoGen’s Annual Report on Form 10-K for the year ended December
31, 2017 and other reports filed with the Securities and Exchange
Commission.
Financials Follow
IMMUNOGEN, INC. SELECTED FINANCIAL INFORMATION
(in thousands, except per share amounts)
CONDENSED CONSOLIDATED
BALANCE SHEETS (Unaudited) March 31,
December 31, 2018 2017 ASSETS Cash and
cash equivalents $ 218,383 $ 267,107 Other assets
46,582 27,569 Total assets $
264,965 $ 294,676 LIABILITIES
AND SHAREHOLDERS' DEFICIT Current portion of deferred
revenue $ 611 $ 1,405 Other current liabilities 65,616 54,365
Long-term portion of deferred revenue 81,522 93,752 Other long-term
liabilities 153,527 163,049 Shareholders' deficit
(36,311 ) (17,895 ) Total liabilities and
shareholders' deficit $ 264,965 $ 294,676
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (Unaudited) Three Months Ended
March 31, 2018 2017 Revenues: License
and milestone fees $ 11,540 $ 18,730 Non-cash royalty revenue 7,190
7,613 Research and development support 383 1,478 Clinical materials
revenue 702 678
Total revenues 19,815 28,499
Expenses: Research and development 44,831 32,888
General and administrative 9,995 8,119 Restructuring charge
1,731 386 Total operating
expenses 56,557 41,393
Loss from operations (36,742 ) (12,894 ) Non-cash
interest expense on liability related to sale of future royalty
& convertible bonds (3,046 ) (3,575 ) Interest expense on
convertible bonds (24 ) (1,125 ) Other income, net
1,199 249 Net loss $
(38,613 ) $ (17,345 )
Net loss per common share,
basic and diluted $ (0.30 )
$ (0.20 ) Weighted
average common shares outstanding, basic and diluted
130,619 87,160
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180504005074/en/
ImmunoGen, Inc.For InvestorsSarah Kiely,
781-895-0600sarah.kiely@immunogen.comorFor MediaCourtney
O’Konek, 781-895-0158courtney.okonek@immunogen.comorFTI Consulting,
Inc.Robert Stanislaro,
212-850-5657robert.stanislaro@fticonsulting.com
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