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 31, 2016 |
|
December 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 31, 2016 |
|
December 31, 2015 |
|
December 31, 2016 |
|
December 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@argotpartners.com
Investors:
Kimberly Minarovich
+1 646 368 8014
kimberly@argotpartners.com