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
Based on single
agent activity in the MCLA-128 Phase 1/2 clinical trial, Phase 2
combination clinical trials planned to initiate in second half of
2017 for MCLA-128 in two metastatic breast cancer populations:
HER2-positive patients and hormone receptor-positive/HER2-low
patients
Conference call
and webcast to be held today at 4:30 pm ET
UTRECHT, The Netherlands, July 11,
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 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.