Merus Announces Fourth Quarter and Full Year 2016 Financial Results and Corporate Developments
(Thomson Reuters ONE) -
UTRECHT, The Netherlands, April 28, 2017 (GLOBE NEWSWIRE) -- Merus N.V.
(Nasdaq:MRUS), a clinical-stage immuno-oncology company developing innovative
bispecific antibody therapeutics, today announced financial results for the
fourth quarter and full year ended December 31, 2016 and provided a corporate
and clinical update.
"Last year was a transformative period for Merus marked by the signing of a
global collaboration with Incyte, a deal that brings a world class collaborator
to Merus and significant strength to our balance sheet, and that we believe will
significantly advance our proprietary candidates into and through the clinic,"
said Ton Logtenberg, Ph.D., Chief Executive Officer of Merus. "We anticipate
that 2017 will be distinguished by several important data points for our wholly
owned clinical-stage pipeline, beginning with the presentation of data from lead
compound MCLA-128, an ADCC-enhanced Biclonics® that binds to HER2 and HER3, at
the upcoming ASCO annual meeting. We expect to follow this by the clinical
advancement of MCLA-117, with initial phase 1 results in patients with AML
expected in the second half of the year, then we anticipate submitting a
Clinical Trial Application (CTA) for a planned Phase 1/2 clinical trial of MCLA-
158 in patients with colorectal cancer by year end."
Recent Developments
* In March 2017, Merus announced that it was named BioCapital Europe Company
of the Year for 2017. The Company of the Year Award is given to the
organization that has undergone the most substantial transformation in the
previous year and has experienced a breakthrough with respect to its
technology, clinical development, partnering, IPO and/or M&A activities.
* In January 2017, Merus and the Institute for Research in Biomedicine (IRB)
Barcelona, a research center devoted to understanding fundamental questions
about human health and disease, entered into a research collaboration to
jointly develop novel agents that target the tumor microenvironment. The
research collaboration will combine Merus' Biclonics® technology platform
for the discovery and development of therapeutic bispecific antibodies and
IRB's unique cell and animal models to evaluate therapeutic targeting of
stromal cells that support tumor growth and metastasis.
* In December 2016, Merus and Incyte (NASDAQ:INCY) announced a global,
strategic collaboration agreement focused on the research, discovery and
development of bispecific antibodies utilizing Merus' proprietary Biclonics®
technology platform. The agreement grants Incyte certain exclusive rights
for up to eleven bispecific antibody research programs, including two of
Merus' current preclinical immuno-oncology discovery programs. Under the
terms of the collaboration, which closed in January 2017, Incyte paid Merus
an upfront payment of $120 million and purchased 3.2 million common shares
of Merus at $25 per share, for a total equity investment of $80 million.
For one current preclinical program, Merus will retain all rights to develop
and commercialize an approved product in the United States. Merus also has
the option to co-fund development of product candidates arising from two
other programs. For the other eight programs, Merus is eligible to receive
potential development, regulatory and sales milestone payments of up to $350
million per program, for an aggregate milestone opportunity of approximately
$2.8 billion if all milestones are achieved across all eight programs in all
territories, in addition to tiered royalties ranging from 6 to 10 percent on
global sales.
* In November 2016, Merus received favorable rulings for its European patent
EP 2147594 B1 by the Opposition Division of the European Patent Office and
by the Trial Board of the Japanese Patent Office for its Japanese
counterpart JP 5749161. Both patents cover Merus' genetically-modified mice
and their use to produce common light chain human monoclonal antibodies.
* In November 2016, Merus was awarded a grant of ?0.5 million from EUREKA
Eurostars with Aquila BioMedical Ltd. to jointly develop immunological
assays supporting the selection of potent bispecific antibodies that
positively modulate tumor immunity with superior potency and lower toxicity
compared to existing drugs.
Anticipated 2017 Milestones
* Clinical data on MCLA-128 will be presented at the 2017 ASCO Annual Meeting
taking place on June 2-6, 2017 in Chicago. The abstract is entitled, "First
in human phase 1/2 study of MCLA-128, a full length IgG1 bispecific antibody
targeting HER2and HER3; final phase 1 data and preliminary activity in HER2+
metastatic breast cancer (mBC)."
* An Investigational New Drug application to the U.S. Food and Drug
Administration of MCLA-117 for a Phase 1 trial is planned during the second
half of 2017.
* During the second half of 2017, Merus expects to report topline data from
its Part 2 of Phase 1/2 monotherapy trial of MCLA-128 in patients with solid
tumors in multiple indications.
* During the second half of 2017, Merus expects to report interim results from
its Phase 1 clinical trial evaluating MCLA-117 in patients with AML.
* By the end of 2017, Merus expects to file a CTA for a planned Phase 1/2
clinical trial of MCLA-158 in patients with colorectal cancer.
Fourth Quarter 2016 Financial Results
(Euros in millions, except as indicated)
Total revenue for the three months ended December 31, 2016 was ?1.1 million
compared to ?0.4 million for the same period in 2015. Revenue is comprised
primarily of research funding, milestone payments and income from grants on
research projects.
Research and development expenses for the three months ended December 31, 2016
were ?7.5 million compared to ?4.8 million for the same period in 2015.
For the three months ended December 31, 2016, Merus reported a net loss of ?30.7
million, or ?(1.91) per share (basic and diluted), compared to a net loss of
?6.6 million, or ?(0.77) per share (basic and diluted), for the same period in
2015. The net loss for the three months ended December 31, 2016 includes a non-
cash charge of ?19.2 million for the accounting impact of a financial derivative
related to the obligation to deliver shares to Incyte in 2017.
Full Year 2016 Financial Results
(Euros in millions, except as indicated)
Total revenue for the full year 2016 was ?2.7 million compared to ?2.0 million
for the full year 2015. Revenue is comprised primarily of research funding,
milestone payments and income from grants on research projects.
Research and development expenses for the full year 2016 were ?19.0 million
compared to ?16.4 million for the full year 2015.
For the full year 2016, Merus reported a loss of ?47.2 million, or ?(3.57) per
share (basic and diluted), compared to a net loss of ?23.2 million, or ?(3.95)
per share (basic and diluted) for the full year in 2015. The loss for the full
year 2016 includes a non-cash charge of ?19.2 million for the accounting impact
of a financial derivative related to the obligation to deliver shares to Incyte
in 2017.
Merus ended the 2016 full year with cash and cash equivalents of ?56.9 million.
On January 23, 2017, the Company closed its global strategic research
collaboration with Incyte Corporation, which included an upfront payment of $120
million and the purchase by Incyte of 3.2 million of Merus' common shares for
$80 million.
About MCLA-128
MCLA-128 is designed to block HER3/heregulin dependent tumor growth and survival
as well as enhance immune-mediated killing of tumors. MCLA-128 employs a 'dock
and block' mechanism in which the mode of HER2 receptor binding orientates the
HER3 binding arm to effectively block oncogenic signaling through the HER2:HER3
heterodimer even under high heregulin concentrations. In addition, MCLA-128 is
engineered for enhanced ADCC in order to recruit and activate immune effector
cells to directly kill the tumor.
About MCLA-117
MCLA-117 is a Biclonics® that is designed to bind to CD3 expressed by T-cells
and CLEC12A expressed by acute myeloid leukemia (AML) tumor cells and stem
cells. In preclinical studies, MCLA-117 has been shown to recruit and activate
the immune system's own T-cells to kill AML tumor cells and stem cells.
About MCLA-158
MCLA-158 is an ADCC-enhanced Biclonics® being developed for the treatment of
colorectal cancer and other solid tumors. MCLA-158 is designed to bind to Lgr5
and EGFR expressing cancer stem cells, block growth and survival pathways and
enhance the recruitment of immune effector cells to directly kill cancer stem
cells that persist in solid tumors causing relapse and metastasis.
About Merus N.V.
Merus is a clinical-stage immuno-oncology company developing innovative full
length human bispecific antibody therapeutics, referred to as Biclonics®.
Biclonics® are based on the full-length IgG format, are manufactured using
industry standard processes and have been observed in preclinical studies to
have several of the same features of conventional monoclonal antibodies, such as
long half-life and low immunogenicity. Merus' lead bispecific antibody
candidate, MCLA-128, is being evaluated in a Phase 1/2 clinical trial in Europe
as a potential treatment for HER2-expressing solid tumors. Merus' second
bispecific antibody candidate, MCLA-117, is being developed in a Phase 1
clinical trial in patients with acute myeloid leukemia. The Company also has a
pipeline of proprietary bispecific antibody candidates in preclinical
development, including MCLA-158, which is designed to bind to cancer stem cells
and is being developed as a potential treatment for colorectal cancer and other
solid tumors, and Biclonics® designed to bind to various combinations of
immunomodulatory molecules, including PD-1 and PD-L1.
Forward Looking Statement
Except for the historical information set forth herein, this press release
contains predictions, estimates and other forward-looking statements, including
without limitation statements regarding: the impact of our collaboration with
Incyte on the clinical development of our bispecific antibody candidates,
anticipated clinical data points for 2017, the timing of presentations, clinical
data announcements, and regulatory filings, the potential payments under our
collaboration agreement with Incyte, each statement under "Anticipated
Milestones," and the treatment potential of our bispecific antibody candidates.
These forward-looking statements are based on management's current expectations.
These statements are neither promises nor guarantees, but involve known and
unknown risks, uncertainties and other important factors that may cause our
actual results, performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by the forward-
looking statements, including, but not limited to, the following: our need for
additional funding, which may not be available and which may require us to
restrict our operations or require us to relinquish rights to our technologies
or bispecific antibody candidates; potential delays in regulatory approval,
which would impact the ability to commercialize our product candidates and
affect our ability to generate revenue; the lengthy and expensive process of
clinical drug development, which has an uncertain outcome; the unpredictable
nature of our early stage development efforts for marketable drugs; potential
delays in enrollment of patients, which could affect the receipt of necessary
regulatory approvals; our reliance on third parties to conduct our clinical
trials and the potential for those third parties to not perform satisfactorily;
we may not identify suitable bispecific antibody candidates under our
collaboration with Incyte or Incyte may fail to perform adequately under our
collaboration; and our reliance on third parties to manufacture our product
candidates, which may delay, prevent or impair our development and
commercialization efforts.
These and other important factors discussed under the caption "Risk Factors" in
our Annual Report on Form 20-F filed with the Securities and Exchange
Commission, or SEC, on April 28, 2017, and our other reports filed with the SEC
could cause actual results to differ materially from those indicated by the
forward-looking statements made in this press release. Any such forward-looking
statements represent management's estimates as of the date of this press
release. While we may elect to update such forward-looking statements at some
point in the future, we disclaim any obligation to do so, even if subsequent
events cause our views to change, except as required under applicable law. These
forward-looking statements should not be relied upon as representing our views
as of any date subsequent to the date of this press release.
Consolidated Statement of Financial Position
December December
31, 2016 31, 2015
----------------- -----------------
(euros in thousands, unaudited)
Non-current assets
Property, plant and equipment 648 325
Intangible assets 374 435
Restricted cash 167 218
----------------- -----------------
1,189 978
Current assets
Financial asset 11,847 -
Trade and other receivables 2,357 1,665
Cash and cash equivalents 56,917 32,851
----------------- -----------------
71,120 34,516
----------------- -----------------
Total assets 72,310 35,494
----------------- -----------------
Shareholders' equity
Issued and paid-in capital 1,448 775
Share premium account 139,878 90,909
Accumulated loss (107,295 ) (63,382 )
----------------- -----------------
Total equity 34,031 28,302
Non-current liabilities
Borrowings 319 486
Deferred revenue 30,206 390
Current liabilities
Borrowings 167 167
Trade payables 2,298 2,419
Taxes and social security liabilities 29 142
Deferred revenue 1,610 223
Other liabilities and accruals 3,650 3,365
----------------- -----------------
7,754 6,316
----------------- -----------------
Total liabilities 38,280 7,192
----------------- -----------------
Total equity and liabilities 72,310 35,494
----------------- -----------------
Consolidated Statement of Profit or Loss and Comprehensive Loss
Three months ended Year ended
-------------- ------------- -------------- --------------
December December December December
31, 2016 31, 2015 31, 2016 31, 2015
-------------- ------------- -------------- --------------
(euros in thousands, except per share data, unaudited)
Revenue 1,115 373 2,719 1,977
Research and
development costs (7,485 ) (4,844 ) (18,991 ) (16,350 )
Management and
administration
costs (3,858 ) (368 ) (4,258 ) (768 )
Other expenses (1,079 ) (1,835 ) (7,142 ) (7,898 )
-------------- ------------- -------------- --------------
Total operating
expenses (12,422 ) (7,047 ) (30,391 ) (25,016 )
-------------- ------------- -------------- --------------
Operating result (11,307 ) (6,674 ) (27,672 ) (23,039 )
Finance income 74 36 88 50
Finance costs (19,457 ) (8 ) (19,644 ) (195 )
-------------- ------------- -------------- --------------
Total finance
income (expenses) (19,383 ) 28 (19,556 ) (145 )
-------------- ------------- -------------- --------------
Result before tax (30,691 ) (6,646 ) (47,228 ) (23,184 )
Income tax expense - - - -
-------------- ------------- -------------- --------------
Result after
taxation (30,691 ) (6,646 ) (47,228 ) (23,184 )
Exchange
differences from
translation of
foreign operations 8 - 8 -
-------------- ------------- -------------- --------------
Other
comprehensive
income 8 - 8 -
-------------- ------------- -------------- --------------
Total
comprehensive loss
(30,683 ) (6,646 ) (47,220 ) (23,184 )
-------------- ------------- -------------- --------------
Basic (and
diluted) loss per
share (1.91 ) (0.77 ) (3.57 ) (3.95 )
-------------- ------------- -------------- --------------
Contacts:
Media:
Eliza Schleifstein
+1 973 361 1546
eliza(at)argotpartners.com
Investors:
Kimberly Minarovich
+1 646 368 8014
kimberly(at)argotpartners.com
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Merus N.V. via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 28.04.2017 - 23:13 Uhr
Sprache: Deutsch
News-ID 539193
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contact information:
Town:
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Kategorie:
Business News
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