Merus Announces Second Quarter 2016 Financial Results and Reviews Recent Clinical Progress and Corporate Developments
(Thomson Reuters ONE) -
UTRECHT, The Netherlands, Aug. 08, 2016 (GLOBE NEWSWIRE) -- Merus N.V.
(Nasdaq:MRUS), a clinical-stage immuno-oncology company developing innovative
bispecific antibody therapeutics, today announced financial results for the
second quarter ended June 30, 2016 and provided a review of recent
accomplishments and clinical development plans.
"We ended the second quarter with ?71.1 million of cash and cash equivalents,
which provides us with the funding to achieve several development milestones,"
said Ton Logtenberg, PhD, Chief Executive Officer of Merus. "We look forward to
reporting on the progress of our lead HER2 x HER3 bispecific candidate, MCLA-
128, our CLEC12A x CD3 bispecific candidate, MCLA-117, as well as our earlier
stage pipeline."
Recent Clinical Developments
* Announced that the first patient has been dosed in a Phase 1/2 clinical
trial evaluating Merus' second Biclonics® therapeutic candidate, MCLA-117,
in patients with acute myeloid leukemia (AML).
* Presented interim Phase 1/2 clinical data in a poster presentation at the
American Association for Cancer Research (AACR) 2016 Annual Meeting
demonstrating a favorable safety profile and early signs of anti-tumor
activity of MCLA-128 in patients with advanced solid tumors.
Upcoming Milestones
* By the end of 2016, Merus expects to report interim results from Part 2 of a
Phase 1/2 clinical trial of MCLA-128 in breast cancer.
* Also by the end of 2016, Merus expects to file an Investigational New Drug
application with the U.S. Food and Drug Administration for a Phase 1/2 trial
of MCLA-128.
* During the second half of 2017, Merus expects to report topline data from
its Phase 1/2 monotherapy trial of MCLA-128 in patients with solid tumors in
multiple indications.
* By the end of 2017, Merus expects to report interim results from Part 1 of
its Phase 1/2 clinical trial evaluating MCLA-117 in patients with AML.
Corporate Highlights
* Closed a successful initial public offering in May which raised net proceeds
to Merus, after deducting underwriting discounts and commissions and
offering expenses, of $53.3 million.
* Issued three patents related to the generation of bispecific antibodies and
high-throughput functional screening methods of large collections of
bispecific antibodies.
* Formed a strategic collaboration with Institut Gustave Roussy, a leading
Comprehensive Cancer Centre in Europe, to jointly develop bispecific
antibodies for therapeutic immuno-oncology applications.
* Announced the closing of a commercial multi-product license for Probiogen's
Glymaxx © ADCC Enhancement technology.
* Appointed Mr. Gregory Perry to the Supervisory Board as well as Chair of the
Audit Committee.
* Incorporated Merus US, Inc and opened a new office in Cambridge,
Massachusetts, USA.
Second Quarter 2016 Financial Results
(Euros in millions)
Total revenue for the three months ended June 30, 2016 was ?1.1 million compared
to ?1.2 million for the same period in 2015. Revenue is comprised primarily of
research funding and income from grants on research projects.
Research and development expenses for the three months ended June 30, 2016 were
?3.9 million compared to ?3.8 million for the same period in 2015. Research and
development costs are comprised primarily of R&D headcount and other costs
related to the development of Merus' two lead bispecific antibody candidates,
MCLA-128 and MCLA-117, as well as manufacturing costs related to MCLA-158.
For the three months ended June 30, 2016, Merus reported a net loss of ?(4.9)
million, or ?(0.40) per basic and diluted share, compared to a net loss of
?(5.6) million, or ?(1.25) per basic and diluted share, for the same period in
2015.
Merus ended the quarter with cash and cash equivalents of ?71.1 million.
About MCLA-128
MCLA-128 is an ADCC-enhanced Biclonics® that binds to HER2- and HER3- expressing
solid tumor cells. MCLA-128 is designed to overcome the inherent and acquired
resistance of tumor cells to HER2-targeted therapies using two mechanisms: 1)
blocking growth and survival pathways to stop tumor expansion while preventing
tumor cells escaping through activation of the HER3/heregulin pathway and 2)
recruitment and enhancement of 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 as a potential
treatment for 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
This press release contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. All statements contained in
this press release that do not relate to matters of historical fact should be
considered forward-looking statements, including without limitation statements
regarding the sufficiency of our cash and cash equivalents for advancing our
therapeutic candidates, the timing of results from our clinical trials and of
regulatory filings, each statement under "Upcoming Milestones," and the
treatment potential for 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: we have
incurred significant losses, are not currently profitable and may never become
profitable; our need for additional funding, which may not be available and
which may require us to restrict out 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 unproven
approach to therapeutic intervention of our Biclonics® technology; potential
difficulties in validating and developing companion diagnostics, which could
harm our development strategy; our limited operating history; economic,
political, regulatory and other risks involved with international operations;
exchange rate fluctuations or abandonment of the euro currency; 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 adverse public reaction to the use of cancer immunotherapies;
potential delays in enrollment of patients, which could affect the receipt of
necessary regulatory approvals; our potential exposure to costly and damaging
liability claims; post-marketing restrictions or withdrawal from the market;
failure to obtain marketing approval internationally; compliance with
environmental, health, and safety laws and regulations; anti-kickback, fraud,
abuse, and other healthcare laws and regulations exposing us to potential
criminal sanctions; recently enacted or future legislation; failure to compete
successfully against other drug companies; potential competition from other drug
companies if we fail to obtain orphan drug designation or maintain orphan drug
exclusivity for our products; the possibility that governmental authorities and
health insurers may not establish adequate reimbursement levels and pricing
policies to support our products; the potential failure of our product
candidates to be accepted on the market by the medical community; our lack of
experience selling, marketing and distributing products and our lack of internal
capability to do so; potential competition from biosimilars; our reliance on
third parties to conduct our clinical trials and the potential for those third
parties to not perform satisfactorily; our reliance on third parties to
manufacture our product candidates, which may delay, prevent or impair our
development and commercialization efforts; protection of our proprietary
technology; our patents being found invalid or unenforceable; potential lawsuits
for infringement of third-party intellectual property; adequate protection of
our trademarks; our potential failure to obtain extensions of the terms of
patents covering our products; potential difficulties protecting our
intellectual property rights in certain jurisdictions; changes in United States
patent law; protection of the confidentiality of our trade secrets; claims
asserting that we or our employees misappropriated a third-party's intellectual
property or otherwise claiming ownership of what we regard as our intellectual
property; compliance with patent regulations; potential system failures; our
ability to attract and retain key personnel; managing our growth could result in
difficulties; the price of our common stock may fluctuate substantially; certain
of our shareholders and members of our management board own a majority of our
outstanding shares and exercise significant control over us; a significant
portion of our total outstanding shares are eligible to be sold into the market;
provisions of our Articles of Association or Dutch corporate law might deter
favorable acquisition bids for us or prevent a beneficial change of control; we
may lose our foreign private issuer status and incur significant expenses as a
result; and unfavorable or lacking analyst research or reports might cause the
price of our common shares to decline.
These and other important factors discussed under the caption "Risk Factors" in
our final prospectus filed with the Securities and Exchange Commission, or SEC,
on May 20, 2016 relating to our Registration Statement on Form F-1, 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. 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.
Merus N.V.
Unaudited Condensed Consolidated Statement of Financial Position
(after appropriation of result for the period)
June December
30, 2016 31, 2015
(euros in thousands)
Non-current assets
Property, plant and equipment 428 325
Intangible assets 404 435
Restricted cash 195 218
Total non-current assets 1,027 978
Current assets
Trade and other receivables 1,440 1,665
Cash and cash equivalents 71,149 32,851
Total current assets 72,589 34,516
Total assets 73,616 35,494
Shareholders' equity
Issued and paid-in capital 1,448 775
Share premium account 139,981 90,909
Accumulated loss (73,067 ) (63,382 )
Total equity 68,362 28,302
Non-current liabilities
Borrowings 417 486
Deferred revenue 279 390
Current liabilities
Borrowings 167 167
Trade payables 1,711 2,419
Taxes and social security liabilities 65 142
Deferred revenue 223 223
Other liabilities and accruals 2,392 3,365
Total current liabilities 4,558 6,316
Total liabilities 5,254 7,192
Total equity and liabilities 73,616 35,494
Merus N.V.
Unaudited Condensed Consolidated Statement of Profit or Loss and Comprehensive
Loss
Three month period ended
June 30,
2016 2015
(euros in thousands, except per
share data)
Revenue 1,098 1,157
Research and development costs (3,945 ) (3,786 )
Management and administration (373 ) (149 )
costs
Other expenses (1,664 ) (2,775 )
Total operating expenses (5,982 ) (6,710 )
Operating result (4,884 ) (5,553 )
Finance income 23 1
Finance costs (13 ) (11 )
Total finance income / 10 (10 )
(expenses)
Result before tax (4,874 ) (5,563 )
Income tax expense - -
Result after taxation (4,874 ) (5,563 )
Other comprehensive income
Exchange differences on the translation of - -
foreign operations
Total other comprehensive loss (4,874 ) (5,563 )
for the period
Total comprehensive loss for the (4,874 ) (5,563 )
period
Basic (and diluted) loss per (0.40 ) (1.25 )
share
Contacts:
Merus N.V.
Shelley Margetson - s.margetson(at)merus.nl
+31 (0)30 253 8800
Argot Partners
Eliza Schleifstein - eliza(at)argotpartners.com
1-917-763-8106
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(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Merus N.V. via GlobeNewswire
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