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, 2017 |
December 31, 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
June 30, |
|
Six months ended
June 30, |
|
|
(euros in thousands, except per share
data) |
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
|
|
|
Revenue |
|
4,027 |
|
|
1,098 |
|
|
6,313 |
|
|
1,945 |
|
Research
and development costs |
|
(8,420 |
) |
|
(3,822 |
) |
|
(15,427 |
) |
|
(8,028 |
) |
Management and administration costs |
|
(3,492 |
) |
|
(496 |
) |
|
(7,694 |
) |
|
(1,014 |
) |
Other
expenses |
|
(2,277 |
) |
|
(1,664 |
) |
|
(4,120 |
) |
|
(3,277 |
) |
Total operating expenses |
|
(14,189 |
) |
|
(5,982 |
) |
|
(27,241 |
) |
|
(12,319 |
) |
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 (expense) / income |
|
(11,542 |
) |
|
10 |
|
|
(22,086 |
) |
|
38 |
|
Result before taxation |
|
(21,704 |
) |
|
(4,874 |
) |
|
(43,014 |
) |
|
(10,336 |
) |
Income
tax expense |
|
(107 |
) |
|
- |
|
|
(118 |
) |
|
- |
|
Result after taxation |
|
(21,811 |
) |
|
(4,874 |
) |
|
(43,132 |
) |
|
(10,336 |
) |
Other comprehensive income |
|
|
|
|
|
|
|
|
Exchange differences on the translation of foreign operations |
|
13 |
|
|
- |
|
|
18 |
|
|
3 |
|
Total other comprehensive income for the
period |
|
13 |
|
|
- |
|
|
18 |
|
|
3 |
|
Total comprehensive loss for the period |
|
(21,798 |
) |
|
(4,874 |
) |
|
(43,114 |
) |
|
(10,333 |
) |
Basic (and diluted) loss per share |
|
(1.12 |
) |
|
(0.40 |
) |
|
(2.27 |
) |
|
(1.00 |
) |
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
1546eliza@argotpartners.com
Investors:Kimberly Minarovich +1 646 368
8014kimberly@argotpartners.com
Incyte (NASDAQ:INCY)
Historical Stock Chart
From Aug 2024 to Sep 2024
Incyte (NASDAQ:INCY)
Historical Stock Chart
From Sep 2023 to Sep 2024