Balance sheet strengthened with $120 million
upfront payment and an $80 million share purchase from Incyte
Corporation for global strategic research collaboration to discover
and develop bispecific antibodies
Merus N.V. (Nasdaq:MRUS), a clinical-stage immuno-oncology company
developing innovative bispecific antibody therapeutics
(Biclonics®), today announced financial results for the first
quarter ended March 31, 2017 and provided a corporate and
clinical update.
“The first quarter and recent period were marked
most notably by the announcement of Phase 1/2 clinical trial data
for our lead product candidate MCLA-128, an ADCC-enhanced
Biclonics® designed to bind to and block growth factor receptors
HER2 and HER3, which demonstrated single-agent anti-tumor activity
in a heavily pre-treated cohort of metastatic breast cancer (MBC)
patients,” said Ton Logtenberg, Ph.D., Chief Executive Officer of
Merus. “Given these encouraging results, we plan to initiate a
Phase 2 open-label, multicenter clinical trial of MCLA-128 in
HER2-positive MBC patients and in hormone
receptor-positive/HER2-low MBC patients in the fourth quarter of
2017.”
Dr. Logtenberg continued, “Also in the second
half of this year, we expect to reach important clinical and
regulatory milestones for two other Biclonics® therapeutic
candidates, MCLA-117 and MCLA-158. Biclonics® are designed to have
functionalities that compare favorably against other forms of
immunotherapeutics, such as conventional mAbs as well as their
combinations, and have the potential to be a more effective
treatment for cancer patients. With the Biclonics® therapeutic
candidates arising from this platform now emerging in the clinic,
we look forward to providing additional updates across our pipeline
in the coming quarters.”
Recent Developments
- At the 2017 American Society of Clinical Oncology (ASCO) in May
2017, Merus presented a poster entitled, “First in human phase 1/2
study of MCLA-128, a full length IgG1 bispecific antibody targeting
HER2 and HER3; final phase 1 data and preliminary activity in HER2+
metastatic breast cancer (MBC),” which detailed clinical results
from a Phase 1/2 clinical trial of MCLA-128 in solid tumors,
including final Phase 1 data in patients with HER2+ MBC. Part 1 of
the Phase 1/2 clinical trial showed that MCLA-128 was safe and
well-tolerated and established the Phase 2 recommended dose of
MCLA-128 in a cohort of 28 advanced solid tumor patients.In the
ongoing Part 2 of the study, treatment was completed for a cohort
of heavily pre-treated HER2+ MBC patients (n=11) using MCLA-128 as
a single agent. Overall, the clinical benefit rate (defined as
complete response plus partial response plus stable disease lasting
at least 12 weeks) among a total of 11 MBC patients was 64%.
Evaluation of MCLA-128 in other indications, including endometrial,
ovarian, and gastric cancers and NSCLC is ongoing.
- Shelley Margetson, Chief Operating Officer, will leave the
Company effective August 1, 2017. Ms. Margetson has
served in her current role since November 2016. She also served as
Executive Vice President and Chief Financial Officer of Merus from
2010 until 2016.
Anticipated 2017 Milestones
- With single agent activity established in MBC, the initiation
of a Phase 2, open label, multi-center international clinical trial
is anticipated in the fourth quarter of 2017 to evaluate
MCLA-128-based combinations in two MBC populations:
(1) confirmed HER2-positive MBC patients (progressing on 2-4
anti-HER2 therapies, including TDM-1) who will receive MCLA-128 in
combination plus 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 a total of 120 patients with 60 patients
targeted in each cohort.
- Decision to support further development path on MCLA-128 in
gastric cancer expected in the fourth quarter of 2017.
- During the second half of 2017, Merus expects to complete the
dose escalation phase of its Phase 1 clinical trial evaluating
MCLA-117 in patients with AML. The study is being conducted in
Europe under a Clinical Trial Application (CTA). An
Investigational New Drug application to the U.S. Food and Drug
Administration of MCLA-117 for the ongoing Phase 1 trial is planned
during the second half 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.
First Quarter 2017 Financial
Results
Merus ended the first quarter of 2017 with cash and
cash equivalents of €236.5 million. The increase in the
Company’s cash position from €56.9 million at
December 31, 2016 was the result of a $120 million
upfront payment and an $80 million share purchase by Incyte
Corporation (NASDAQ:INCY) (Incyte) under the terms of a global,
strategic research collaboration for the development of bispecific
antibodies utilizing Merus’ Biclonics® technology platform. In
connection with the collaboration, Incyte purchased
3.2 million common shares of Merus at $25 per share, for a
total equity investment of $80 million. The collaboration was
announced in December 2016 and became effective in January 2017
upon the closing of the share purchase by Incyte.
Total revenue for the three months ended
March 31, 2017 was €2.3 million compared to
€0.8 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 expenses for the three
months ended March 31, 2017 were €7.0 million compared to
€4.2 million for the same period in 2016.
For the three months ended March 31, 2017,
Merus reported a net loss of €21.3 million, or €(1.15) per
share (basic and diluted), compared to a net loss of
€5.5 million, or €(0.63) per share (basic and diluted), for
the same period in 2016. The net loss for the three months ended
March 31, 2017 includes a non-cash charge of
€10.7 million for the accounting impact of a financial
derivative related to the obligation to deliver shares to Incyte in
2017.
Conference Call Details
Merus will hold a conference call to provide a
mid-year update and discuss its financial results today,
July 11, 2017 at 4:30 p.m. ET. To listen to the conference
call, dial (646) 722-4972 (domestic); international callers dial
(866) 978-9968 (international) and provide the passcode 98331903.
In addition, the presentation will be webcast live, and may be
accessed for up to 90 days following the call, by visiting the
“Investors” section of the Company’s website, www.merus.nl. An
accompanying slide presentation also can be accessed via the
“Investors” section of the website.
About MCLA-128
MCLA-128 is an ADCC-enhanced Biclonics® designed to
block HER3/heregulin-dependent tumor growth and survival as well as
effectively recruit immune cells to attack tumor cells. MCLA-128
employs a ‘dock and block’ mechanism in which the HER2 receptor
binding orientates the HER3 binding arm to effectively block
oncogenic signaling through the HER2:HER3 heterodimer even under
high heregulin concentrations.
About MCLA-117
MCLA-117 is an Fc-silenced Biclonics® 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.
Through Fc-silencing, MCLA-117 avoids binding to Fc receptors
present on macrophages and other blood cells that could result in
toxicity.
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 expected to begin
a Phase 2 clinical 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.
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 timing of initiating the Phase 2 clinical
trial of MCLA-128 in MBC patients, the timing for meeting clinical
and regulatory milestones for MCLA-117 and MCLA-158, the treatment
potential of our Biclonic® candidates, including their ability to
treat cancer, the effectiveness of Ms. Margetson’s departure
from Merus, and 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 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 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; our ability
to protect 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; 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) |
|
|
March 31, |
December 31, |
|
2017 |
|
2016 |
|
|
(euros in thousands) |
Non-current
assets |
|
|
Property, plant and
equipment |
758 |
|
648 |
|
Intangible assets |
358 |
|
374 |
|
Restricted cash |
— |
|
167 |
|
|
1,116 |
|
1,189 |
|
Current
assets |
|
|
Financial asset |
— |
|
11,847 |
|
Taxes and social
security assets |
1,082 |
|
— |
|
Trade and other
receivables |
2,190 |
|
2,357 |
|
Cash and cash
equivalents |
236,512 |
|
56,917 |
|
|
239,784 |
|
71,120 |
|
Total
assets |
240,900 |
|
72,310 |
|
Shareholders’
equity |
|
|
Issued and paid-in
capital |
1,745 |
|
1,448 |
|
Share premium
account |
213,523 |
|
139,878 |
|
Accumulated loss |
(123,985 |
) |
(107,295 |
) |
Total equity |
91,283 |
|
34,031 |
|
Non-current
liabilities |
|
|
Borrowings |
— |
|
319 |
|
Deferred revenue |
135,529 |
|
30,206 |
|
Current
liabilities |
|
|
Borrowings |
— |
|
167 |
|
Trade payables |
4,275 |
|
2,298 |
|
Taxes and social
security liabilities |
203 |
|
29 |
|
Deferred revenue |
6,943 |
|
1,610 |
|
Other liabilities and
accruals |
2,667 |
|
3,650 |
|
|
14,088 |
|
7,754 |
|
Total
liabilities |
149,617 |
|
38,280 |
|
Total equity
and liabilities |
240,900 |
|
72,310 |
|
Unaudited Condensed Consolidated Statement of
Profit or Loss and Comprehensive Loss |
|
|
Three month period ended |
|
March 31, |
|
2017 |
|
2016 |
|
|
(euros in thousands, except per share
data) |
Revenue |
2,286 |
|
847 |
|
Research and
development costs |
(7,007 |
) |
(4,206 |
) |
Management and
administration costs |
(4,202 |
) |
(518 |
) |
Other expenses |
(1,843 |
) |
(1,613 |
) |
Total operating
expenses |
(13,052 |
) |
(6,337 |
) |
Operating
result |
(10,766 |
) |
(5,490 |
) |
Finance income |
190 |
|
33 |
|
Finance costs |
(10,734 |
) |
(5 |
) |
Total finance
income / (expenses) |
(10,544 |
) |
28 |
|
Result before
tax |
(21,310 |
) |
(5,462 |
) |
Income tax expense |
(11 |
) |
— |
|
Result after
taxation |
(21,321 |
) |
(5,462 |
) |
Other
comprehensive income |
|
|
Exchange differences on
the translation of foreign operations |
5 |
|
3 |
|
Total other
comprehensive loss for the period |
5 |
|
3 |
|
Total
comprehensive loss for the period |
(21,316 |
) |
(5,459 |
) |
Basic (and
diluted) loss per share* |
(1.15 |
) |
(0.63 |
) |
* For the periods included in these
financial statements, the share options are not included in the
diluted loss per share calculation as the Company was loss-making
in all these periods. Due to the anti-dilutive nature of the
outstanding options, basic and diluted loss per share is equal.
Basic and diluted loss per share as of March 31, 2016 was
adjusted to conform to the current period presentation.
Contacts:
Media:
Eliza Schleifstein
+1 973 361 1546
eliza@argotpartners.com
Investors:
Kimberly Minarovich
+1 646 368 8014
kimberly@argotpartners.com
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