Merus Announces Second Quarter 2017 Financial Results and Highlights Recent Progress
(Thomson Reuters ONE) -
Merus Announces Second Quarter 2017 Financial Results and Highlights Recent
Progress
UTRECHT, The Netherlands, Sept. 19, 2017 (GLOBE NEWSWIRE) -- Merus
N.V. (NASDAQ:MRUS), a clinical-stage immuno-oncology company developing
innovative bispecific antibody therapeutics (Biclonics(®)), today announced
financial results for the second quarter ended June 30, 2017 and provided a
corporate and clinical update.
"Merus has had a productive year to date, marked by progress in our work with
Incyte and our other collaborators, the presentation at ASCO of positive Phase
1/2 data for our lead candidate MCLA-128 in the first of several indications,
and progress among a stable of very exciting Biclonics®-based bispecific
antibody therapy candidates toward and through the clinic," said Ton Logtenberg,
Ph.D., Chief Executive Officer of Merus. "We believe that the potential of
Merus' Biclonics® platform, which holds a number of key advantages over other
bispecific antibody approaches, has only just begun to reveal itself."
"The balance of the year holds a number of key anticipated milestones, including
initiating a Phase 2 trial of MCLA-128-based combinations in two metastatic
breast cancer (MBC) populations, a decision on development of MCLA-128 in
gastric, ovarian and endometrial cancers based on an expected data readout,
progression of dose escalation in the Phase 1 trial evaluating MCLA-117 in acute
myeloid leukemia (AML) under a Clinical Trial Authorization (CTA), filing of an
Investigational New Drug (IND) submission for MCLA-117, and filing of a CTA for
a first-in-human clinical trial of MCLA-158 in patients with colorectal cancer.
We also look forward to initiating an IND-enabling study for MCLA-145, a
bispecific antibody designed to bind to PD-L1 and to another undisclosed
immunomodulatory target, a program that is part of our collaboration with
Incyte," added Dr. Logtenberg.
Recent Clinical & Corporate Developments
* In Part 2 of the Phase 1/2 MCLA-128 study in solid tumors, treatment was
completed for a cohort of heavily pre-treated HER2+ MBC patients (n=11)
using MCLA-128 as a single agent which resulted in an overall clinical
benefit rate (defined as complete response plus partial response plus stable
disease lasting at least 12 weeks) of 64%. With single agent activity
established in MBC, the initiation of a Phase 2 clinical trial is
anticipated in the fourth quarter of 2017 described further below under
"Anticipated 2017 Milestones".
* Merus and Incyte Corporation (NASDAQ:INCY) have advanced the first candidate
from their global strategic research collaboration into an IND-enabling
study. MCLA-145 is designed to bind to PD-L1 and to a second undisclosed
immunomodulatory target to treat various solid tumors. Merus has full rights
to develop and commercialize MCLA-145 in the United States and Incyte is
responsible for its development and commercialization outside the United
States.
* Merus received a favorable ruling from the U.S. Court of Appeals for the
Federal Circuit which affirmed that Regeneron Pharmaceuticals engaged in
inequitable conduct during the patent prosecution of U.S. Patent No.
8,502,018, resulting in the patent's unenforceability.
Anticipated 2017 Milestones
* During the fourth quarter, Merus expects to initiate a Phase 2, open label,
multi-center international clinical trial to evaluate MCLA-128-based
combinations in two MBC populations: (1) confirmed HER2-positive MBC
patients (progressing on 2 to 4 anti-HER2 therapies, including TDM-1) who
will receive MCLA-128 in combination with trastuzumab with and without
chemotherapy, and (2) confirmed ER+/HER2-low MBC patients progressing on one
or more prior endocrine therapies and CDK4/6 inhibitors who will receive
MCLA-128 in combination with endocrine therapy. The trial is expected to
enroll approximately 120 patients in total with approximately 60 patients
targeted in each cohort.
* Merus is continuing its dose escalation of the Phase I clinical trial for
MCLA-117 in Europe and expects to submit an IND application to the U.S. Food
and Drug Administration in the fourth quarter of 2017.
* By the end of 2017, Merus expects to file a CTA for a first-in-human
clinical trial of MCLA-158 in patients with colorectal cancer.
Second Quarter 2017 Financial Results
Merus ended the second quarter of 2017 with cash and cash equivalents of ?215.8
million compared to ?56.9 million at December 31, 2016.
Total revenue for the three months ended June 30, 2017 was ?4.0 million compared
to ?1.1 million for the same period in 2016. Revenue is comprised primarily of
amortization of the Incyte upfront license payment, research funding and income
from grants on research projects.
Research and development costs for the three months ended June 30, 2017 were
?8.4 million compared to ?3.8 million for the same period in 2016. The increase
in research and development costs quarter over quarter, reflects higher
enrollment in our clinical trials and expansion of pre-clinical research efforts
to support our collaboration with Incyte.
For the three months ended June 30, 2017, Merus reported a net loss of
?21.8 million, or a loss of ?1.12 per basic and diluted share, compared to a net
loss of ?4.9 million, or a loss of ?0.40 per basic and diluted share, for the
same period in 2016. The net loss for the three months ended June 30, 2017
includes approximately ?12.0 million of unrealized foreign currency losses and
approximately ?3.3 million of non-cash, share option expenses.
Financial Outlook
Based on current operating plans, Merus expects that its current cash and cash
equivalents balance will be sufficient to fund its research and development
programs and operations well into 2019.
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®, which are based on the full-length IgG format, are manufactured
using industry standard processes and have been observed in preclinical studies
to have similar features as conventional monoclonal antibodies, such as long
half-life and low immunogenicity. Merus' lead bispecific antibody candidate,
MCLA-128, is expected to begin a Phase 2 combination trial in the second half of
2017 in two metastatic breast cancer populations. MCLA-128 is also being
evaluated in a Phase 1/2 clinical trial in Europe in gastric, ovarian,
endometrial and non-small cell lung cancers. 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, as well as
MCLA-145 designed to bind to PD-L1 and a non-disclosed second immunomodulatory
target, which is being developed in collaboration with Incyte Corporation. For
additional information, please visit Merus' website, www.merus.nl.
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 potential of our Biclonics® platform, the timing of initiating the
Phase 2 combination trial of MCLA-128 in MBC patients, the treatment potential
of our Biclonics® candidates, and key anticipated milestones, including each
statement under "Anticipated 2017 Milestones."
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 Biclonics® and bispecific antibody candidates; potential delays in regulatory
approval, which would impact our 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 Biclonics® or bispecific antibody candidates under
our collaboration with Incyte or Incyte may fail to perform adequately under our
collaboration; 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
may be found invalid, unenforceable, circumvented by competitors and our patent
applications may be found not to comply with the rules and regulations of
patentability; we may fail to prevail in existing and potential lawsuits for
infringement of third-party intellectual property; and our registered or
unregistered trademarks or trade names may be challenged, infringed,
circumvented or declared generic or determined to be infringing on other marks.
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.
Merus N.V.
Unaudited Condensed Consolidated Statement of Financial Position
(after appropriation of result for the period)
June 30, December 31,
2017 2016
------------------------------
(euros in thousands)
Non-current assets
Property, plant and equipment 1,057 648
Intangible assets 343 374
Restricted cash - 167
Other assets 109 109
------------------------------
1,509 1,298
Current assets
Financial asset - 11,847
Taxes and social security receivables 2,024 -
Trade receivables and other current assets 4,308 2,248
Cash and cash equivalents 215,788 56,917
------------------------------
221,120 71,012
------------------------------
Total assets 223,629 72,310
------------ ---------------
Shareholders' equity
Issued and paid-in capital 1,746 1,448
Share premium account 213,541 139,878
Accumulated loss (142,529 ) (107,295 )
------------------------------
Total equity 72,758 34,031
Non-current liabilities
Borrowings - 319
Deferred revenue, net of current portion 133,666 30,206
Current liabilities
Borrowings - 167
Trade payables 3,971 2,298
Taxes and social security liabilities 748 29
Deferred revenue 7,052 1,610
Other liabilities and accruals 5,434 3,650
------------------------------
17,205 7,754
------------------------------
Total liabilities 150,871 38,279
------------------------------
Total equity and liabilities 223,629 72,310
------------------------------
Unaudited Condensed Consolidated Statement of Profit or Loss and Comprehensive
Loss
Three months ended Six months ended
June 30, June 30,
(euros in thousands, except per share data)
2017 2016 2017 2016
Revenue 4,027 1,098 6,313 1,945
Research and (8,420 ) (3,822 ) (15,427 ) (8,028 )
development costs
Management and (3,492 ) (496 ) (7,694 ) (1,014 )
administration costs
Other expenses (2,277 ) (1,664 ) (4,120 ) (3,277 )
Total operating (14,189 ) (5,982 ) (27,241 ) (12,319 )
expenses
Operating result (10,162 ) (4,884 ) (20,928 ) (10,374 )
Finance income 420 23 610 56
Finance costs (11,962 ) (13 ) (22,696 ) (18 )
Total finance (11,542 ) 10 (22,086 ) 38
(expense) / income
Result before (21,704 ) (4,874 ) (43,014 ) (10,336 )
taxation
Income tax expense (107 ) - (118 ) -
Result after (21,811 ) (4,874 ) (43,132 ) (10,336 )
taxation
Other comprehensive
income
Exchange
differences on the 13 - 18 3
translation of
foreign operations
Total other
comprehensive income 13 - 18 3
for the period
Total comprehensive (21,798 ) (4,874 ) (43,114 ) (10,333 )
loss for the period
Basic (and diluted) (1.12 ) (0.40 ) (2.27 ) (1.00 )
loss per share
Weighted average
shares outstanding
Basic (and diluted) 19,392,495 12,133,195 18,976,446 10,365,753
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: 19.09.2017 - 22:05 Uhr
Sprache: Deutsch
News-ID 560519
Anzahl Zeichen: 18627
contact information:
Town:
Utrecht
Kategorie:
Business News
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