− Conference call at 8:00 am ET today will
include update on mirvetuximab soravtansine, the first folate
receptor α (FRα)-targeting antibody-drug conjugate (ADC), including
the design of the FORWARD I trial −
ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company
developing targeted cancer therapeutics using its proprietary ADC
technology, today reported financial results for the three-month
period ended March 31, 2016 – the third quarter of the Company’s
2016 fiscal year. ImmunoGen also provided an update on the
Company’s lead program, mirvetuximab soravtansine, and other wholly
owned clinical-stage product candidates.
“We are making important progress with our key product
programs,” commented Daniel Junius, President and CEO. “In early
June, expanded Phase 1 findings with mirvetuximab soravtansine will
be presented at ASCO. Based on these data, we are modifying the
design of our FORWARD I trial to be a Phase 3 study intended to
support full marketing approval. Patient enrollment is proceeding
well in our Phase 1b/2 FORWARD II trial that is assessing this
novel ADC in combination regimens, and patient dosing has begun in
Phase 1 testing of IMGN779, the first ADC utilizing one of our new
DNA-alkylating cancer-killing agents.”
Mr. Junius continued, “Our partners are also making progress.
Takeda has reported preclinical information on a GCC-targeting ADC
it is developing utilizing our DNA-alkylating technology, and
Novartis and Sanofi recently presented preclinical data on product
candidates with our maytansinoid technology. Phase 1 clinical data
with Bayer’s anetumab ravtansine and Sanofi’s SAR566658 are
scheduled for poster discussion at ASCO, with data also being
presented on Sanofi’s isatuximab.”
ImmunoGen Product Program Updates
Mirvetuximab soravtansine – First FRα-targeting ADC;
potential new treatment for FRα-positive ovarian cancer.
- Data will be presented at ASCO from a
46-patient Phase 1 expansion cohort assessing this ADC as
monotherapy for FRα-positive platinum-resistant ovarian cancer
(abstract #5567). This cohort was increased from 20 patients to
provide additional experience in the patient population to better
inform the design of ImmunoGen’s FORWARD I trial. The data
presented will be updated from the 20-patient data reported
previously and from that available at the time of abstract
submission.
- Based on the expanded findings,
ImmunoGen is modifying its FORWARD I trial from a two-stage, Phase
2 trial with response rate as the primary endpoint to a
single-stage, Phase 3 trial with progression-free survival as the
primary endpoint. Patients with FRα-positive (medium or high)
platinum-resistant ovarian cancer treated with up to three prior
regimens will be eligible for enrollment.
- Patient enrollment is ongoing in the
FORWARD II trial assessing mirvetuximab soravtansine in combination
regimens. A cohort is being added to assess this novel ADC in
combination with Merck’s anti-PD1, pembrolizumab.
IMGN779 – First-in-class CD33-targeting ADC utilizing a
DNA-alkylating cancer-killing agent from ImmunoGen’s new family
called IGNs.
- Patient enrollment has started in the
Phase 1 trial assessing this ADC for the treatment of acute myeloid
leukemia.
IMGN529 and coltuximab ravtansine – CD37- and
CD19-targeting, respectively, ADCs for diffuse large B-cell
lymphoma (DLBCL).
- Patient enrollment is expected to open
shortly in a Phase 2 trial assessing IMGN529 in combination with
rituximab and in 1H2017 for coltuximab ravtansine in a combination
regimen.
Update on Partner Programs
- Phase 1 findings with Sanofi’s
SAR566658 and Bayer’s anetumab ravtansine ADCs with ImmunoGen
technology have been accepted for poster discussion at ASCO, with
data also being presented on Sanofi’s isatuximab (SAR650984).
- ImmunoGen, Novartis, and Sanofi had
multiple ADC-related presentations at the American Association of
Cancer Research (AACR) annual meeting earlier this month. Those by
ImmunoGen scientists featured new, novel technologies while those
by Novartis and Sanofi related to cadherin6- and LAMP1-targeting
ADCs, respectively, utilizing ImmunoGen maytansinoid ADC
technology.
- Takeda reported data at a scientific
conference on a GCC-targeting ADC the company is developing
utilizing one of ImmunoGen’s new IGN agents.
Financial Results
For the Company’s quarter ended March 31, 2016 (3QFY2016),
ImmunoGen reported a net loss of $31.9 million, or $0.37 per basic
and diluted share, compared to a net loss of $21.6 million, or
$0.25 per basic and diluted share, for the same quarter last year
(3QFY2015).
Revenues for 3QFY2016 were $19.7 million, compared to
$11.4 million for 3QFY2015. The current period includes a $10
million milestone earned from Bayer with the advancement of
anetumab ravtansine into a Phase 2 clinical trial designed to
support product registration. License and milestone fees for the
prior year period include a $5 million milestone earned from
Novartis with its initiation of LOP628 Phase 1 clinical testing.
Revenues in 3QFY2016 include $7.4 million of non-cash royalty
revenues, compared with $5.1 million in cash royalty revenues for
the prior year period. Revenues for 3QFY2016 also include
$1.2 million of clinical materials revenue and $1.1 million of
research and development support fees, compared with $0.7 million
and $0.5 million, respectively, in the prior year period.
Operating expenses in 3QFY2016 were $47.3 million, compared
to $32.7 million in 3QFY2015. Operating expenses in 3QFY2016
include research and development expenses of $36.1 million,
compared to $25.7 million in 3QFY2015. 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
$11.2 million in 3QFY2016, compared to $7 million in
3QFY2015. This increase is primarily due to a non-cash stock
compensation charge resulting from the CEO transition, as well as
increased personnel expenses and professional services.
ImmunoGen had approximately $182.9 million in cash and cash
equivalents as of March 31, 2016, compared with $278.1 million as
of June 30, 2015, and had no debt outstanding in either
period. Cash used in operations was $91.6 million in the first nine
months of FY2016, compared with $26.8 million in the same
period in FY2015. The prior year period benefited from $25 million
in upfront payments received including $20 million in connection
with the execution of the right-to-test agreement with Takeda in
March 2015, as well as lower operating expenses. Capital
expenditures were $8.6 million and $4.5 million for the first nine
months of FY2016 and FY2015, respectively.
Financial Guidance for Fiscal Year 2016
ImmunoGen has updated its guidance for its fiscal year ending
June 30, 2016. Expected revenues are now projected to be between
$60 million and $70 million, compared with previous guidance of
between $70 million and $80 million. The change is primarily due to
changes in the expected timing of partner events and is mainly
non-cash. Operating expenses are now projected to be between $180
million and $185 million, compared with previous guidance of
between $175 million and $180 million. The change is primarily
related to greater clinical trial costs and non-cash stock
compensation charges. The Company’s guidance for its net loss is
now expected to be between $135 million and $140 million, compared
to its previous estimate of $120 million and $125 million with most
of this change being non-cash related.
ImmunoGen now projects cash and cash equivalents at June 30,
2016 to be between $155 million and $160 million, compared to
previous guidance of $165 million to $170 million. This change
reflects the cash impact of less partner upfront and milestone
payments. The Company’s guidance for cash used in operations is now
projected to be between $110 million and $115 million, which had
previously been $100 million and $105 million. The Company’s
guidance for capital expenditures remains unchanged, which is
between $13 million and $15 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
913-312-0936; the conference ID is 7099318. 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 May 13, 2016.
About ImmunoGen, Inc.
ImmunoGen is a clinical-stage biotechnology company that
develops targeted anticancer therapeutics using its proprietary ADC
technology. The Company’s lead product candidate, mirvetuximab
soravtansine, has demonstrated encouraging activity and
tolerability in early clinical testing for folate receptor
α-positive ovarian cancer and is progressing to advanced clinical
testing. ImmunoGen's ADC technology is used in Roche's marketed
product, Kadcyla®, and in programs in development by partners
Amgen, Bayer, Biotest, CytomX, Lilly, Novartis, Sanofi and Takeda.
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.
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) March
31, June 30, 2016 2015 ASSETS Cash
and cash equivalents $ 182,913 $ 278,109 Other assets 39,434
35,714 Total assets $ 222,347 $ 313,823
LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities $
39,830 $ 35,810 Long-term portion of deferred revenue and other
long-term liabilities 223,660 242,909 Shareholders' equity
(41,143) 35,104 Total liabilities and shareholders'
equity $ 222,347 $ 313,823
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
Three Months Ended Nine Months Ended March 31,
March 31, 2016 2015
2016 2015
Revenues: License and milestone fees $ 10,077 $ 5,078 $ 26,839 $
52,729 Royalty revenue - 5,099 195 13,890 Non-cash royalty revenue
7,380 - 19,355 - Clinical materials revenue 1,198 718 3,526 4,171
Research and development support 1,059 532 2,679
2,140 Total revenues 19,714 11,427 52,594
72,930 Expenses: Research and development 36,094 25,666
109,425 81,331 General and administrative 11,235
7,000 27,618 20,967 Total operating expenses 47,329
32,666 137,043 102,298 Loss from operations (27,615)
(21,239) (84,449) (29,368) Non-cash interest expense on
liability related to sale of future royalty (4,972) - (15,174) -
Other income (loss), net 659 (379) 728 (897)
Net loss $ (31,928) $ (21,618) $ (98,895) $ (30,265)
Net
loss per common share, basic and diluted $ (0.37)
$ (0.25) $ (1.14) $
(0.35) Weighted average common shares
outstanding, diluted 87,035 86,080
86,948 85,962
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version on businesswire.com: http://www.businesswire.com/news/home/20160429005132/en/
ImmunoGen, Inc.For Investors:Carol Hausner,
781-895-0600info@immunogen.comorFor Media:Michael Lampe,
484-575-5040michael@scientpr.com
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