− Conference Call Today at 8:00 am ET −
- Level of target expression on patient
tumors may have a marked impact on response to mirvetuximab
soravtansine, ImmunoGen’s novel folate receptor α (FRα)-targeting
antibody-drug conjugate (ADC); data to be reported at
AACR-NCI-EORTC in November.
- Patient enrollment completed in Phase 1
ovarian cancer cohort that ImmunoGen plans to discuss with
regulators in 2016. Company on track to initiate trials designed to
potentially support an Accelerated Approval pathway (FORWARD I) and
market expansion (FORWARD II) for mirvetuximab soravtansine.
- Broader pipeline progress includes
advancement of another ImmunoGen ADC and three partner ADCs to
IND/clinical testing.
ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that
develops targeted anticancer therapeutics using its ADC technology,
today reported financial results for the three-month period ended
September 30, 2015 – the first quarter of the Company’s 2016 fiscal
year. ImmunoGen also provided an update on product programs and
reiterated its guidance for its 2016 fiscal year.
“We believe mirvetuximab soravtansine has the potential to make
an important difference for many patients with FRα-positive cancers
and look forward to the upcoming data presentations at
AACR-NCI-EORTC,” commented Daniel Junius, President and CEO. “Of
particular note are the findings suggesting that the level of FRα
expression on patient tumors has a marked impact on response to
mirvetuximab soravtansine. As noted in the abstract that became
public yesterday, the response rate was 53% for the patients
reported at ASCO and 80% in the subset with the highest expression
– about half of the 22 patients treated. Updated response data,
including duration, for these patients will be reported at
AACR-NCI-EORTC.”
Mr. Junius continued, “We are successfully executing on all of
our product programs – completing enrollment in the 40-patient
ovarian cancer Phase 1 expansion cohort well ahead of plan, moving
forward with combination strategies for our two ADCs for B-cell
malignancies, and submitting the IND for our fourth wholly owned
program, IMGN779, to the FDA on schedule. There also has been
notable progress by a number of our partners.”
Updates on Product Programs
Mirvetuximab soravtansine (formerly IMGN853) – for
FRα-positive cancers including ovarian cancer.
- Data
presentations at the upcoming AACR-NCI-EORTC conference will
feature:
- Findings from an analysis of the
relationship between level of FRα expression on patient tumor cells
and response to treatment with mirvetuximab soravtansine (abstract
C47). This analysis indicates patients with higher levels of target
expression on their tumors are more likely to respond to treatment
with mirvetuximab soravtansine. The findings helped inform that
FORWARD I would enroll patients with medium or high levels of
expression, with stratification by expression level.
- Preclinical evaluation of mirvetuximab
soravtansine combination therapy (abstract C170) provides findings
on mirvetuximab soravtansine used in combination with bevacizumab
(Avastin®) and the other agents to be assessed in FORWARD II.
- Clinical
progress: patient enrollment completed – ahead of plan – in
the Phase 1 40-patient expansion cohort assessing mirvetuximab
soravtansine monotherapy for FRα-positive platinum-resistant
ovarian cancer. Patient enrollment is also ahead of plan in the
20-patient ovarian cancer cohort examining biomarkers using
biopsies taken before and on treatment, and is progressing in the
endometrial cancer expansion cohort. Data presentation for each of
these cohorts is targeted for 2Q2016. Cohorts for additional types
of FRα-positive cancers are expected to be added to this Phase 1
trial.
- Phase 2
testing: ImmunoGen remains on track to initiate its FORWARD
I and FORWARD II trials by year end. FORWARD I evaluates
mirvetuximab soravtansine used alone to treat patients with
FRα-positive ovarian cancer previously treated with 3-4 regimens
and could potentially support an Accelerated Approval pathway.
FORWARD II assesses doublet combinations of mirvetuximab
soravtansine and bevacizumab (Avastin®), carboplatin, and pegylated
liposomal doxorubicin (Doxil®) in less pretreated FRα-positive
ovarian cancer.
IMGN529 and coltuximab ravtansine (formerly
SAR3419) – for diffuse large B-cell lymphoma (DLBCL) and
potentially other B-cell malignancies.
- Data
presentations at upcoming ASH conference: preclinical
findings with each compound used in combination with approved
anticancer therapies.
- Clinical
progress, Phase 2 testing: maximum tolerated dose identified
in single agent, Phase 1 assessment of IMGN529 for B-cell
non-Hodgkin lymphoma. Company on track to start Phase 2 assessments
of IMGN529 and of coltuximab ravtansine in combination regimens by
the end of 2015 and in 2016, respectively.
IMGN779 – CD33-targeting ADC for acute myeloid leukemia
and myelodysplastic syndrome; utilizes the first of ImmunoGen's new
DNA-acting payload agents.
- Data
presentation at upcoming ASH conference: mechanism of action
findings.
- Clinical
progress: IND submitted to FDA; on track for initiation of
patient dosing in early 2016.
Partner compounds – Recent highlights include:
- Promising single-agent activity in
recurrent mesothelioma from a Phase 1b trial was reported with
Bayer’s anetumab ravtansine (BAY 94-9343) at the 16th World
Conference on Lung Cancer.
- Eli Lilly and Company advanced its
FGFR3-targeting ADC, LY3076226, into clinical testing in September,
triggering a milestone payment to ImmunoGen. Additionally,
ImmunoGen earned a milestone payment from Amgen with its
advancement of a new ADC.
- Patient dosing began with Sanofi’s
LAMP1-targeting ADC, SAR428926, in October, also triggering a
milestone payment to ImmunoGen.
There are now seven companies with novel anticancer compounds in
the clinic utilizing ImmunoGen’s technology: Amgen, Bayer, Biotest,
Genentech/Roche, Lilly, Novartis and Sanofi. Companies advancing
earlier-stage ADCs include CytomX and Takeda.
Financial Results
For the Company’s quarter ended September 30, 2015 (1QFY2016),
ImmunoGen reported a net loss of $33.7 million, or $0.39 per basic
and diluted share, compared to a net loss of $22.3 million, or
$0.26 per basic and diluted share, for the same quarter last year
(1QFY2015).
Revenues for 1QFY2016 were $14.9 million, compared to
$13.2 million for 1QFY2015. They include $6.1 million of
license and milestone fees, comprised principally of a $5 million
milestone earned from Lilly and a $1 million milestone earned from
Amgen with the advancement by each of an ADC with ImmunoGen
technology. Revenues also include $5.7 million of non-cash
royalties on Roche sales of Kadcyla for the three-months ended June
30, 2015. Additionally, revenues for 1QFY2016 include
$2.3 million of clinical materials revenue and $0.8 million of
research and development support fees. The level of research
support and the number of batches of clinical materials produced
and released to partners varies on a quarter-to-quarter basis.
Operating expenses in 1QFY2016 were $43.5 million, compared
to $35.1 million in 1QFY2015. Operating expenses in 1QFY2016
include research and development expenses of $35.1 million,
compared to $28.0 million in 1QFY2015. This change is
primarily due to increased third-party costs related to the
advancement of our wholly owned product candidates, increased
clinical trial costs, primarily related to our expansion of the
mirvetuximab soravtansine development program, and increased
personnel expenses, principally due to recent hiring. Operating
expenses include general and administrative expenses of
$8.3 million in 1QFY2016, compared to $7.1 million in
1QFY2015. This increase is primarily due to increased personnel
expenses and professional services.
ImmunoGen had approximately $247.8 million in cash and cash
equivalents as of September 30, 2015, compared with $278.1 million
as of June 30, 2015, and had no debt outstanding in either
period. Cash used in operations was $31.4 million in the first
three months of FY2016, compared with $18.9 million in the
same period in FY2015. Capital expenditures were $3.4 million and
$1.7 million for the first three months of FY2016 and FY2015,
respectively.
Financial Guidance for Fiscal Year 2016
ImmunoGen’s financial guidance remains unchanged from that
issued in July 2015. ImmunoGen expects: its revenues to be between
$70 million and $80 million; its operating expenses to be
between $175 million and $180 million; its net loss to be
between $120 million and $125 million; its cash used in operations
to be between $100 million and $105 million; and its
capital expenditures to be between $13 million and
$15 million. Cash and marketable securities at June 30, 2016
are anticipated to be between $165 million and
$170 million.
Conference Call Information
ImmunoGen is holding a conference call today at 8:00 am ET to
discuss these results. To access the live call by phone, dial
913-905-3226; the conference ID is 9613638. The call also may 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 November 10,
2015.
About ImmunoGen, Inc.
ImmunoGen is a clinical-stage biotechnology company that
develops targeted anticancer therapeutics with its proprietary
antibody-drug conjugate (ADC) technology. The Company’s lead
product candidate, mirvetuximab soravtansine, is a potential
treatment for folate receptor α-positive ovarian cancers and other
solid tumors. Leading healthcare companies have licensed rights to
use ImmunoGen’s technology to develop novel anticancer therapies,
and Roche’s marketed product, Kadcyla®, utilizes ImmunoGen’s ADC
technology. More information about the Company can be found at
www.immunogen.com.
Avastin®, Doxil®, and Kadcyla® are registered trademarks of
their 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 in its 2016 fiscal year; its
cash and marketable securities as of June 30, 2016; 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
fiscal year ended June 30, 2015 and other reports filed with
the Securities and Exchange Commission.
SELECTED FINANCIAL
INFORMATION (in thousands, except per share amounts)
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited) September 30,
June 30,
2015
2015
ASSETS Cash and cash equivalents $ 247,843 $ 278,109 Other
assets 37,741 35,714 Total
assets $ 285,584 $ 313,823 LIABILITIES AND
SHAREHOLDERS' EQUITY Current liabilities $ 35,948 $ 35,810
Long-term portion of deferred revenue and other long-term
liabilities 238,027 242,909 Shareholders' equity 11,609
35,104 Total liabilities and
shareholders' equity $ 285,584 $ 313,823
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (Unaudited) Three Months Ended
September 30, 2015 2014
Revenues: License and milestone fees $ 6,070 $ 6,234 Royalty
revenue - 4,166 Non-cash royalty revenue 5,684 - Research and
development support 772 776 Clinical materials revenue 2,325
2,027 Total revenues 14,851
13,203 Expenses: Research and
development 35,132 28,018 General and administrative 8,329
7,095 Total operating expenses
43,461 35,113 Loss from operations
(28,610 ) (21,910 ) Non-cash interest expense on liability
related to sale of future royalty (5,143 ) - Other income
(expense), net 13 (372 ) Net loss $
(33,740 ) $ (22,282 )
Net loss per common share, basic
and diluted $ (0.39 ) $
(0.26 ) Weighted average common
shares outstanding, basic and diluted 86,838
85,872
View source
version on businesswire.com: http://www.businesswire.com/news/home/20151027005256/en/
ImmunoGen, Inc.Carol Hausner, 781-895-0600info@immunogen.com
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