UTRECHT, The Netherlands, Nov. 30, 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 third quarter ended September 30, 2017 and provided a clinical update.
“Merus continues to make meaningful advances with both our proprietary pipeline, led by MCLA-128, and our
various collaboration programs,” said Ton Logtenberg, Ph.D., Chief Executive Officer of Merus. “We look forward to several
milestones over the balance of the year, including our plan to initiate a Phase 2 clinical trial of MCLA-128 in combination with
other therapies in HER2 positive and ER+/HER2 low metastatic breast cancer and plan to file a Clinical Trial Application (“CTA”)
for a first-in-human clinical trial of MCLA-158 in patients with colorectal cancer. Our Phase 1/2 clinical trial evaluating single
agent activity for MCLA-128 in gastric, ovarian, endometrial and non-small cell lung (NSCL) cancers is ongoing and we anticipate
defining the clinical plan for MCLA-128 for additional solid tumors in early 2018. Also in 2018, we intend to continue to advance
MCLA-117 in the clinic for acute myeloid leukemia (AML) and progress MCLA-145, being developed in collaboration with Incyte.”
“We are committed to unlocking the full potential of our Biclonics®-based bispecific antibody
platform, and we anticipate 2018 will be an important year for advancing multiple programs in the clinic,” added
Dr. Logtenberg.
Upcoming Milestones
MCLA-128, an enhanced antibody-dependent cell-mediated cytotoxicity (ADCC)
Biclonics® that binds to HER2 and HER3-expressing solid tumor cells
Merus intends to initiate a Phase 2 clinical trial of MCLA-128 in combination with other therapies in HER2
positive and ER+/HER2 low metastatic breast cancer by the end of 2017. In early 2018, Merus expects to formulate its clinical
development plans in gastric, ovarian, endometrial and NSCL cancers based on a data readout from its ongoing Phase 1/2 clinical
trial.
MCLA-117, a Biclonics® that binds to CD3 and
CLEC12A
Merus is continuing its dose escalation of the Phase 1 clinical trial for MCLA-117 in Europe, and expects to
submit an Investigational New Drug application to the U.S. Food and Drug Administration in the first half of 2018.
MCLA-158, an ADCC-enhanced Biclonics® designed to bind to
cancer stem cells expressing Lgr5 and EGFR
Merus expects to file a CTA for a first-in-human clinical trial of MCLA-158 in patients with colorectal cancer
by the end of 2017.
MCLA-145, a Biclonics® designed to bind to PD-L1 and a second
non-disclosed immunomodulatory target
Merus and Incyte are conducting an IND-enabling study for MCLA-145, the first drug candidate co-developed under
their global research collaboration. 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.
Third Quarter 2017 Financial Results
Merus ended the third quarter of 2017 with cash and cash equivalents of €202.4 million compared to
€56.9 million at December 31, 2016.
Total revenue for the three months ended September 30, 2017 was €3.5 million compared to
€1.2 million for the same period in 2016. Revenue is comprised primarily of cost reimbursements, 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 September 30, 2017 were €8.0 million
compared to €4.1 million for the same period in 2016. The increase in research and development costs reflects higher
enrollment in our clinical trials and expansion of research efforts to support our internal programs and collaboration with
Incyte.
For the three months ended September 30, 2017, Merus reported a net loss of €15.7 million, or a loss
of €0.81 per basic and diluted share, compared to a net loss of €4.9 million, or a loss of €0.31 per basic and diluted share,
for the same period in 2016. The net loss for the three months ended September 30, 2017 includes approximately
€5.5 million of foreign currency losses and approximately €2.7 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’ most advanced bispecific antibody
candidate, MCLA-128, is being evaluated in a Phase 2 combination trial 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 most advanced 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, which is designed to bind to PD-L1 and a non-disclosed second
immunomodulatory target and 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 timing of initiating the Phase 2
combination clinical trial of MCLA-128 and defining the clinical development plan for MCLA-128 in additional solid tumors, clinical
development plans for MCLA-117, the timing of filing a Clinical Trial Application for MCLA-158 for a clinical trial in patients
with colorectal cancer, the progress of developing MCLA-145 with Incyte, 2018 being an important period for advancing multiple
clinical programs, each statement under “Upcoming Milestones,” and the sufficiency of our cash and cash equivalents.
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) |
|
|
|
|
|
September 30,
2017 |
December 31,
2016 |
|
(euros in
thousands) |
Non-current assets |
|
|
Property, plant and equipment |
1,008 |
648 |
Intangible assets |
328 |
374 |
Restricted cash |
— |
167 |
Other assets |
123 |
109 |
|
1,459 |
1,298 |
|
|
|
Current assets |
|
|
Financial asset |
— |
11,847 |
Trade receivables and other current assets |
4,062 |
2,248 |
Cash and cash equivalents |
202,424 |
56,917 |
|
206,486 |
71,012 |
Total assets |
207,945 |
72,310 |
|
|
|
Shareholders’ equity |
|
|
Issued and paid-in capital |
1,747 |
1,448 |
Share premium account |
213,551 |
139,878 |
Accumulated loss |
(155,553) |
(107,295) |
Total equity |
59,745 |
34,031 |
Non-current liabilities |
|
|
Borrowings |
— |
319 |
Deferred revenue, net of current portion |
131,903 |
30,206 |
Current liabilities |
|
|
Borrowings |
— |
167 |
Trade payables |
2,837 |
2,298 |
Taxes and social security liabilities |
242 |
29 |
Deferred revenue |
7,052 |
1,610 |
Other liabilities and accruals |
6,166 |
3,650 |
|
16,297 |
7,754 |
Total liabilities |
148,200 |
38,279 |
Total equity and liabilities |
207,945 |
72,310 |
|
|
|
Unaudited Condensed Consolidated Statement of
Profit or Loss and Comprehensive Loss |
|
|
|
|
|
|
|
Three
months ended
September 30, |
Nine
months ended
September 30, |
|
(euros
in thousands, except per share data) |
|
2017 |
2016 |
2017 |
2016 |
Revenue |
3,471 |
1,182 |
9,784 |
3,127 |
Research and development costs |
(8,040) |
(4,074) |
(23,075) |
(11,924) |
Management and administration costs |
(3,634) |
(546) |
(11,432) |
(1,560) |
Other expenses |
(2,180) |
(1,522) |
(6,588) |
(4,977) |
Total operating expenses |
(13,854) |
(6,142) |
(41,095) |
(18,461) |
Operating result |
(10,383) |
(4,960) |
(31,311) |
(15,334) |
Finance income |
254 |
25 |
864 |
74 |
Finance costs |
(5,519) |
(10) |
(28,215) |
(21) |
Total finance (expense) / income |
(5,265) |
15 |
(27,351) |
53 |
Result before taxation |
(15,648) |
(4,945) |
(58,662) |
(15,281) |
Income tax expense |
(64) |
— |
(181) |
— |
Result after taxation |
(15,712) |
(4,945) |
(58,843) |
(15,281) |
Other comprehensive income |
|
|
|
|
Exchange differences on the translation of foreign operations |
33 |
3 |
51 |
3 |
Total other comprehensive income for the period |
33 |
3 |
51 |
3 |
Total comprehensive loss for the period |
(15,679) |
(4,942) |
(58,792) |
(15,278) |
Basic (and diluted) loss per share |
(0.81) |
(0.31) |
(3.08) |
(1.24) |
Weighted average shares outstanding |
|
|
|
|
Basic (and diluted) |
19,402,667 |
16,085,851 |
19,120,081 |
12,293,405 |
|
|
|
|
|
Contacts:
Media:
Eliza Schleifstein
+1 973 361 1546
eliza@argotpartners.com
Investors:
Kimberly Minarovich
+1 646 368 8014
kimberly@argotpartners.com