− Conference call at 8:00 am ET today –
- Following positive meeting with FDA,
Phase 3 FORWARD I study of mirvetuximab soravtansine in patients
with platinum-resistant ovarian cancer on track to begin before
year end.
- Mirvetuximab soravtansine plus Avastin®
combination regimen advanced to Phase 2 in FORWARD II trial.
- Phase 1 testing of IMGN779 – the first
ADC deploying an ImmunoGen DNA-alkylating payload – initiated in
patients with acute myeloid leukemia (AML).
- Recent appointment of Mark Enyedy as
President and CEO brings proven leadership and deep experience
building oncology businesses.
- Company ended fiscal year with
approximately $245 million in cash and is moving to reporting on
calendar-year basis.
ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today provided an update on the Company’s progress and reported
financial results for its fourth quarter and fiscal year ended June
30, 2016.
“With our lead candidate poised to enter Phase 3 and a portfolio
of well-differentiated programs advancing behind it, I am excited
to have joined the strong team managing ImmunoGen’s transition to a
fully-integrated biotech company,” stated Mark Enyedy, President
and CEO. “We will build upon ImmunoGen’s leadership position in
ADCs by focusing on four strategic priorities: complete development
and commercialize mirvetuximab soravtansine, accelerate our
earlier-stage portfolio, continue to drive innovation in ADCs for
the treatment of cancer, and support new and existing partnerships.
As we execute on these priorities, we will look to improve the
efficiency of our operations and more effectively manage our cash
position.”
Mr. Enyedy continued, “We made significant progress on these
priorities over the past three months, including meeting with the
FDA to review the path to registration for mirvetuximab
soravtansine and our proposed Phase 3 trial, FORWARD I. With the
benefit of the guidance provided by the agency, we are moving ahead
with the study as designed and expect to enroll our first patient
before year end. Following successful dose escalation, we have also
initiated a 35-patient, Phase 2 expansion cohort for mirvetuximab
soravtansine in combination with Avastin as part of our FORWARD II
trial. With the initiation of Phase 1 dose escalation for IMGN779
and the progression of IMGN632 into pre-IND testing, we continue to
advance our earlier-stage candidates deploying our new IGN payload
technology to broaden the range of ADC-treatable cancers. The
progress with our product candidates and those of our partners
demonstrates ImmunoGen’s continuing commitment to drive ADC
innovation to improve the lives of patients with cancer.”
Pipeline Updates
Mirvetuximab Soravtansine
Mirvetuximab soravtansine is a well-differentiated experimental
therapy for the treatment of ovarian cancer and potentially other
tumor types that express its target, folate receptor alpha (FRα).
This ADC is being evaluated in clinical trials as a single-agent
therapy for platinum-resistant ovarian cancer and in combination
regimens for both platinum-resistant and platinum-sensitive
disease.
Single-Agent Therapy
- Held Type B meeting with the U.S. Food
and Drug Administration (FDA) to review the path to registration
for mirvetuximab soravtansine and the proposed FORWARD I study
protocol. With the benefit of the agency’s guidance, ImmunoGen is
moving forward with initiating this Phase 3 trial as previously
outlined, including with the primary endpoint of progression-free
survival (PFS).
- Reported data from 46 patients with
FRα-positive platinum-resistant ovarian cancer at the American
Society of Clinical Oncology (ASCO) meeting in June. Mirvetuximab
soravtansine demonstrated robust single-agent activity in these
patients, with the greatest response rates and PFS reported in
patients with high or medium levels of FRα expression on their
tumors and who had received up to three prior regimens, the patient
population eligible for enrollment in FORWARD I.
Strategic Combination Regimens
- Initiated the 35-patient Phase 2
assessment in FORWARD II of mirvetuximab soravtansine in
combination with Avastin following successful completion of dose
finding.
- Continued enrollment in the FORWARD II
cohorts assessing the ADC used with pegylated liposomal doxorubicin
(PLD) and, separately, with carboplatin, with the cohort assessing
the combination with Keytruda® on track to open this summer.
Exploring Additional Opportunities
- Through ImmunoGen’s collaboration with
the National Comprehensive Cancer Network (NCCN), grants were
awarded for clinical assessment of mirvetuximab soravtansine in
combination with gemcitabine and as a treatment of triple negative
breast cancer as well as for preclinical studies on mechanisms of
resistance, sensitivity, and biomarkers.
IMGN779 / IMGN632
IMGN779 and IMGN632 deploy ImmunoGen’s new ultra-potent,
DNA-acting payload agents that alkylate DNA without crosslinking
it. In preclinical studies, these agents have been found to avoid
the sustained toxicity seen with DNA-crosslinking agents.
- Initiated Phase 1 clinical testing of
IMGN779, a CD33-targeting ADC, for the treatment of AML. Initial
clinical data from this trial are expected to be presented in
2017.
- Advanced CD123-targeting IMGN632 into
IND-enabling testing. The first preclinical findings with this
novel ADC were presented at the European Hematology Association
annual meeting, with additional data on its distinctive activity
and tolerability expected to be presented in late 2016.
IMGN529
IMGN529 deploys ImmunoGen’s validated maytansinoid payload
technology and recently gained orphan drug status in diffuse large
B-cell lymphoma (DLBCL).
- Initiated Phase 2 clinical testing of
IMGN529 used in combination with Rituxan® for patients with B-cell
malignancies including DLBCL based on marked synergy in preclinical
testing.
Fiscal Year 2016 Financial Results
ImmunoGen’s fiscal year 2016 ended June 30, 2016. The Company is
moving to reporting on a calendar year basis, effective January 1,
2017.
For the Company’s fiscal year ended June 30, 2016 (FY2016),
ImmunoGen reported a net loss of $143.7 million, or $1.65 per basic
and diluted share, compared to a net loss of $60.7 million, or
$0.71 per basic and diluted share, for its fiscal year ended June
30, 2015 (FY2015). For the quarter ending June 30, 2016, ImmunoGen
reported a net loss of $44.8 million, or $0.51 per basic and
diluted share, compared to a net loss of $30.5 million, or
$0.35 per basic and diluted share, for the same quarter in
FY2015.
Revenues in FY2016 were $60.0 million, compared to
$85.5 million in FY2015, with the decrease principally due to
reduced non-cash revenue from the amortization of upfront fees.
FY2016 revenues include $26.9 million of license and milestone fees
compared to $57.8 million in FY2015. The current period
includes less revenue from the amortization of previously-received
upfront fees than the prior period, $8.6 million and $41.4 million,
respectively, and more revenue from partner milestone payments,
$18.0 million and $14.0 million, respectively. Revenues in FY2016
also include $25.5 million of royalty revenues, all but $200,000 of
which was non-cash, compared with $19.4 million for FY2015, of
which $5.5 million was non-cash and $13.9 million was cash.
Revenues for FY2016 also include $4.0 million of research and
development support fees and $3.6 million of clinical
materials revenue, compared with $2.8 million and $5.5 million,
respectively, in such fees for FY2015. The changes reflect
variations in the level of research support and the number of
batches of clinical materials produced and released to partners on
a year-to-year basis.
Operating expenses in FY2016 were $183.8 million, compared
to $140.0 million in FY2015, with the increase principally due to
costs associated with ImmunoGen advancing mirvetuximab soravtansine
and other innovative, wholly-owned product candidates. Research and
development expenses were $146.9 million in FY2016, compared to
$111.8 million in FY2015. The increase in FY2016 is primarily
due to increased clinical trial costs, particularly related to
mirvetuximab soravtansine, to greater third-party costs related to
ImmunoGen product program advancement, and to increased personnel
expenses, principally due to hiring in the first three quarters of
FY2016. General and administrative expenses were $36.9 million
in FY2016, compared to $28.2 million in FY2015. This increase
is primarily due to increased personnel expenses, particularly
higher non-cash stock compensation costs which include a
substantial charge resulting from the CEO transition, and to a
lesser extent, increased third-party service fees.
ImmunoGen had approximately $245.0 million in cash and cash
equivalents and $100.0 million of convertible debt outstanding
as of June 30, 2016, compared with $278.1 million of cash and cash
equivalents and no debt on June 30, 2015. Cash used in
operations was $124.5 million in FY2016, compared with $55.3
million in FY2015. Capital expenditures were $10.4 million and $7.4
million for FY2016 and FY2015, respectively.
Financial Guidance
ImmunoGen is transitioning to a fiscal year ending December 31,
effective January 1, 2017. For the six months ending December 31,
2016, ImmunoGen expects: revenues to be between $40 million
and $45 million; operating expenses to be between $95 million
and $100 million; net loss to be between $55 million and $60
million; cash used in operations to be between $65 million and
$70 million; and capital expenditures to be between $2 million
and $5 million. Cash and marketable securities at December 31,
2016 are anticipated to be between $170 million and
$175 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
913-312-1463; the conference ID is 3243361. 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 August 18, 2016.
About ImmunoGen, Inc.
ImmunoGen is a clinical-stage biotechnology company that
develops targeted cancer therapeutics using its proprietary ADC
technology. ImmunoGen’s lead product candidate, mirvetuximab
soravtansine, is being advanced to a Phase 3 trial for FRα-positive
platinum-resistant ovarian cancer, and is in Phase 1b/2
testing in combination regimens for earlier-stage disease.
ImmunoGen’s ADC technology is used in Roche's marketed product,
Kadcyla®, in three other clinical-stage ImmunoGen product
candidates, and in programs in development by partners Amgen,
Bayer, Biotest, CytomX, Lilly, Novartis, Sanofi and Takeda.
Avastin®, Kadcyla®, Keytruda®, and Rituxan® 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 six months ending
December 31, 2016; its cash and marketable securities as of
December 31, 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) June 30, June 30,
2016 2015 ASSETS Cash and
cash equivalents $ 245,026 $ 278,109 Other assets 42,059
35,714 Total assets $ 287,085 $
313,823 LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities $ 60,277 $ 35,810 Long-term portion of deferred
revenue and other long-term liabilities 307,950 242,909
Shareholders' equity (81,142 ) 35,104
Total liabilities and shareholders' equity $ 287,085 $
313,823
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS (Unaudited) Three Months
Ended Fiscal Year Ended June 30, June 30,
2016 2015
2016 2015
Revenues: License and milestone fees $ 76 $ 5,086 $ 26,915 $
57,815 Non-cash royalty revenue 5,944 5,461 25,299 5,461 Royalty
revenue - - 195 13,890 Research and development support 1,335 708
4,014 2,848 Clinical materials revenue 53
1,356 3,579 5,527 Total revenues
7,408 12,611 60,002 85,541
Expenses: Research and development 37,490 30,437 146,915
111,768 General and administrative 9,298 7,261
36,916 28,228 Total operating expenses
46,788 37,698 183,831 139,996
Loss from operations (39,380 ) (25,087 ) (123,829 )
(54,455 ) Non-cash interest expense on liability related to
sale of future royalty & convertible bonds (4,956 ) (5,436 )
(20,130 ) (5,436 ) Other (expense) income, net (424 )
49 304 (848 ) Net loss $ (44,760 ) $ (30,474 )
$ (143,655 ) $ (60,739 )
Net loss per common share, basic
and diluted $ (0.51 ) $
(0.35 ) $ (1.65 ) $
(0.71 ) Weighted average common
shares outstanding, diluted 87,062
86,269 86,976
86,038
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version on businesswire.com: http://www.businesswire.com/news/home/20160804005174/en/
For Investors:ImmunoGen, Inc.Carol Hausner,
781-895-0600info@immunogen.comorFor Media:Michael Lampe,
484-575-5040michael@scientpr.com
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