− Conference Call Today at 8:00 am ET −
- Both ImmunoGen’s FORWARD I and FORWARD
II clinical trials are open for patient enrollment. FORWARD I is
designed to support an Accelerated Approval pathway for lead
program mirvetuximab soravtansine and FORWARD II assesses this
first-in-class folate receptor α (FRα)-targeting antibody-drug
conjugate (ADC) in multiple combination regimens.
- Bayer has initiated a Phase 2 study
designed to support registration of anetumab ravtansine, its
mesothelin-targeting ADC. Anetumab ravtansine is the second partner
ADC – after Roche’s Kadcyla® – with ImmunoGen technology to advance
into potential registration testing. Roche expects findings from
its KRISTINE neoadjuvant trial in 2016, a potential new use for
Kadcyla.
ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that
develops targeted anticancer therapeutics using its proprietary ADC
technology, today reported financial results for the three-month
period ended December 31, 2015 – the second quarter of the
Company’s 2016 fiscal year. ImmunoGen also provided an update on
product programs and reiterated its 2016 fiscal year guidance.
“ImmunoGen is off to a strong start for 2016, with multiple
clinical trial initiations underway,” commented Daniel Junius,
President and CEO. “Of particular importance is the opening of our
FORWARD I trial assessing mirvetuximab soravtansine as single-agent
therapy for pretreated FRα-positive ovarian cancer, which we
believe is the fastest path to registration for this promising ADC.
We expect several presentations of mirvetuximab soravtansine
clinical data in 2016, including mature results from the 40-patient
FRα-positive ovarian cancer Phase 1 cohort.”
Mr. Junius continued, “Our partners also are making meaningful
progress. Of particular note is Bayer’s initiation of a Phase 2
trial designed to support registration of its anetumab ravtansine
product candidate. Roche expects data to be reported from its trial
assessing Kadcyla in the neoadjuvant setting this year and – if
positive – to bring these to regulatory authorities for potential
filing in 2016. A third partner compound is on track to advance
into registration testing later this year.”
Update on Wholly Owned Product Programs
Mirvetuximab soravtansine – First FRα-targeting ADC is a
potential new treatment for ovarian cancer and other FRα-positive
solid tumors.
- Assessments as single-agent therapy for
pretreated FRα-positive ovarian cancer:
- Updated Phase 1 findings were presented
at the AACR-NCI-EORTC meeting in November for the dataset reported
at ASCO in May (abstracts #C47 and #5518, respectively). These
included that 35% (7/20) of patients with FRα-positive
platinum-resistant disease treated had a confirmed objective
response, with most (6/7) responders on mirvetuximab soravtansine
for 6 months or longer. This compares with ImmunoGen’s target
response rate of 30% or more to advance the ADC as monotherapy.
Most of the patients and all of the responders had high or medium
FRα levels on their tumors.
- Patient enrollment is open for the
Company's FORWARD I Phase 2 trial, which is designed to support an
Accelerated Approval pathway for mirvetuximab soravtansine. FORWARD
I is being conducted in partnership with the GOG Foundation, Inc.
To qualify for enrollment, patients must have ovarian cancer with
high or medium FRα expression that was previously treated with 3 or
4 regimens.
-
- Patient enrollment was completed in
4Q2015 in the 20-patient Phase 1 expansion cohort requiring
biopsies. The Company intends to present initial biomarker data
from this assessment at a medical meeting in 2Q2016 in addition to
reporting mature data from the 40-patient Phase 1 cohort in this
disease at the meeting.
- Assessments as combination therapy for
FRα-positive ovarian cancer:
- Encouraging preclinical data with a
range of combination regimens were presented at the AACR-NCI-EORTC
meeting (abstract C170).
- In December, patient dosing began in
the Phase 1b/2 trial, FORWARD II, assessing mirvetuximab
soravtansine in combination with approved anticancer agents.
- Assessments for the treatment of other
FRα-positive cancers:
- In 4Q2015, patient enrollment was
completed in the 20-patient Phase 1 expansion cohort assessing the
ADC for FRα-positive relapsed/refractory endometrial cancer. The
Company expects to report findings from this assessment in
2H2016.
- Additional cancer types are being
evaluated for FRα expression preclinically.
IMGN529 and coltuximab ravtansine – CD37- and
CD19-targeting, respectively, ADCs for diffuse large B-cell
lymphoma (DLBCL) and potentially other B-cell malignancies.
- Preclinical findings of strong synergy
for IMGN529 used in combination with rituximab were reported at ASH
(abstract #1548) in December.
- Patient enrollment in a Phase 2 trial
assessing IMGN529 in combination with rituximab is expected to
begin early this year. Enrollment in a Phase 2 trial assessing
coltuximab ravtansine in a different combination regimen is
expected to begin in 2H2016.
IMGN779 – First CD33-targeting ADC utilizing an IGN
cancer-killing agent. IGNs are a new class of DNA-acting agents
invented by ImmunoGen.
- Mechanism of action data were reported
at ASH (abstract #1366).
- ImmunoGen is preparing to initiate
Phase 1 testing of IMGN779 for the treatment of acute myeloid
leukemia in 1H2016.
Update on Partner Programs
Nine companies are advancing ADCs with ImmunoGen technology.
Recent highlights include:
- Patient dosing has begun in Bayer’s
global Phase 2 clinical trial designed to support registration of
its mesothelin-targeting ADC, anetumab ravtansine. This event
triggers a milestone payment to ImmunoGen that will be reflected in
the Company’s 3QFY2016 financial results.
- Roche expects data from its KRISTINE
trial assessing Kadcyla in the neoadjuvant setting for early
HER2-positive breast cancer to be reported this year and, if
positive, to bring these to regulatory authorities for potential
filing in 2016.
- In December, Takeda took its
first license for the exclusive right to develop ADCs to an
undisclosed target using ImmunoGen technology.
- Also in December, CytomX announced it
is advancing a novel anticancer agent targeting CD166 using its
ProbodyTM technology and ImmunoGen's ADC technology under a
strategic collaboration established between the companies in early
2014.
Financial Results
For the Company’s quarter ended December 31, 2015 (2QFY2016),
ImmunoGen reported a net loss of $(33.2) million, or $(0.38) per
basic and diluted share, compared to net income of
$13.6 million, or $0.16 per basic and diluted share, for the
same quarter last year (2QFY2015).
Revenues for 2QFY2016 were $18.0 million, compared to
$48.3 million for 2QFY2015. The current period includes $8.6
million of amortization of upfront fees previously received from
Takeda and the prior year period includes $41.4 million of
amortization of upfront fees previously received from Novartis and
Lilly. The fees are recognized in their respective quarters due to
the partner taking one or more licenses in the quarter. License and
milestone fees for 2QFY2016 also include a $2 million milestone
earned from Sanofi with the advancement of SAR428926 into clinical
testing. Revenues in 2QFY2016 include $6.3 million of non-cash
royalty revenues and $0.2 million of cash royalty revenues on Roche
sales of Kadcyla for the three-months ended September 30, 2015,
compared with $4.6 million in cash royalty revenues for the prior
year period.
Operating expenses in 2QFY2016 were $46.3 million, compared
to $34.5 million in 2QFY2015. Operating expenses in 2QFY2016
include research and development expenses of $38.2 million,
compared to $27.6 million in 2QFY2015. 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
$8.1 million in 2QFY2016, compared to $6.9 million in
2QFY2015. This increase is primarily due to increased personnel
expenses and professional services.
ImmunoGen had approximately $212.3 million in cash and cash
equivalents as of December 31, 2015, compared with $278.1 million
as of June 30, 2015, and had no debt outstanding in either
period. Cash used in operations was $63.0 million in the first six
months of FY2016, compared with $34.4 million in the same
period in FY2015. Capital expenditures were $7.6 million and $2.6
million for the first six 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 cash equivalents 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
913-312-0836; the conference ID is 5851737. 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 February 12,
2016.
About ImmunoGen, Inc.
ImmunoGen is a clinical-stage biotechnology company that
develops targeted anticancer therapeutics with its proprietary 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. A number of
major healthcare companies have licensed rights to use ImmunoGen's
ADC technology to develop novel anticancer therapies; it is used in
Roche's marketed product, Kadcyla®. More information about the
Company can be found at www.immunogen.com.
Kadcyla® is a registered trademark of Genentech, a member of the
Roche Group.
ProbodyTM is a trademark of CytomX Therapeutics, Inc.
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.
-Financials Follow-
IMMUNOGEN, INC.
SELECTED FINANCIAL
INFORMATION (in thousands, except per share amounts)
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited) December 31, June 30,
2015 2015 ASSETS
Cash and cash equivalents $ 212,283 $ 278,109 Other assets
39,297 35,714 Total assets $ 251,580
$ 313,823 LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities $ 43,900 $ 35,810 Long-term portion of
deferred revenue and other long-term liabilities 224,366 242,909
Shareholders' equity (16,686 ) 35,104
Total liabilities and shareholders' equity $ 251,580 $
313,823
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS (Unaudited) Three Months
Ended Six Months Ended December 31, December
31, 2015 2014
2015 2014
Revenues: License and milestone fees $ 10,692 $ 41,417 $ 16,762 $
47,651 Royalty revenue 195 4,625 195 8,791 Non-cash royalty revenue
6,291 - 11,975 - Research and development support 848 832 1,620
1,608 Clinical materials revenue 3 1,426
2,328 3,453 Total
revenues 18,029 48,300 32,880
61,503 Expenses: Research and
development 38,199 27,647 73,331 55,665 General and administrative
8,054 6,872 16,383
13,967 Total operating expenses 46,253
34,519 89,714 69,632
(Loss) income from operations (28,224 ) 13,781 (56,834 )
(8,129 ) Non-cash interest expense on liability related to
sale of future royalty (5,059 ) - (10,202 ) - Other income (loss),
net 56 (146 ) 69 (518 )
Net (loss) income $ (33,227 ) $ 13,635 $ (66,967 ) $
(8,647 )
Net (loss) income per common share, basic and
diluted $ (0.38 ) $ 0.16
$ (0.77 ) $ (0.10
) Weighted average common shares
outstanding, diluted 86,970
86,665 86,904
85,904
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160129005112/en/
For Investors:ImmunoGen, Inc.Carol Hausner,
781-895-0600info@immunogen.comorFor Media:For ImmunoGen,
Inc.Michael Lampe,
484-575-5040michael@michaellampeconsulting.com
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