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Correcting and Replacing Merus Announces Fourth Quarter and Full Year 2016 Financial Results and Corporate Developments In a release issued

Key Takeaway: Correcting and Replacing Merus Announces Fourth Quarter and Full Year 2016 Financial Results and Corporate Developments In a release issued April 28, 2017 by Merus N.V. (Nasdaq:MRUS) with the same headline, an error was made such that the figures for the three months ended Dece

Full Press Release Details

Correcting and Replacing Merus Announces Fourth Quarter and Full Year 2016 Financial Results and Corporate Developments
In a release issued April 28, 2017 by Merus N.V. (Nasdaq:MRUS) with the same headline, an error was made such that the figures for the three months ended
December 31, 2016 in the Consolidated Statement of Profit or Loss and Comprehensive Loss table were incorrect. The table has been updated, as have the corresponding numbers in the Fourth Quarter 2016 Financial Results
section. The corrected release follows:
Merus Announces Fourth Quarter and Full Year 2016 Financial Results and Corporate Developments
UTRECHT, The Netherlands, May 03, 2017 (GLOBE NEWSWIRE) Merus N.V. (Nasdaq:MRUS), a clinical-stage immuno-oncology company developing
innovative bispecific antibody therapeutics, today announced financial results for the fourth quarter and full year ended December 31, 2016 and provided a corporate and clinical update.
Last year was a transformative period for Merus marked by the signing of a global collaboration with Incyte, a deal that brings a world class
collaborator to Merus and significant strength to our balance sheet, and that we believe will significantly advance our proprietary candidates into and through the clinic, said Ton Logtenberg, Ph.D., Chief Executive Officer of Merus. We
anticipate that 2017 will be distinguished by several important data points for our wholly owned clinical-stage pipeline, beginning with the presentation of data from lead compound MCLA-128, an ADCC-enhanced
Biclonics that binds to HER2 and HER3, at the upcoming ASCO annual meeting. We expect to follow this by the clinical advancement of MCLA-117, with
initial phase 1 results in patients with AML expected in the second half of the year, then we anticipate submitting a Clinical Trial Application (CTA) for a planned Phase 1/2 clinical trial of MCLA-158 in
patients with colorectal cancer by year end.
Anticipated 2017 Milestones
Fourth Quarter 2016 Financial Results
in millions, except as indicated)
Total revenue for the three months ended December 31, 2016 was (0.4) million compared to
0.4 million for the same period in 2015. Revenue is comprised primarily of research funding, milestone payments and income from grants on research projects. Revenue for the three months ended December 31, 2016 was negative because
the Company reversed 0.7m of revenue that had been recognized in a prior period related to a government grant.
Research and development expenses
for the three months ended December 31, 2016 were 6.3 million compared to 4.8 million for the same period in 2015.
For the three months ended December 31, 2016, Merus reported a net loss of 31.9 million, or
(1.99) per share (basic and diluted), compared to a net loss of 6.6 million, or (0.77) per share (basic and diluted), for the same period in 2015. The net loss for the three months ended December 31, 2016 includes a non-cash charge of 19.2 million for the accounting impact of a financial derivative related to the obligation to deliver shares to Incyte in 2017.
Full Year 2016 Financial Results
except as indicated)
Total revenue for the full year 2016 was 2.7 million compared to 2.0 million for the full year 2015.
Revenue is comprised primarily of research funding, milestone payments and income from grants on research projects.
Research and development expenses for
the full year 2016 were 19.0 million compared to 16.4 million for the full year 2015.
For the full year 2016, Merus reported a loss
of 47.2 million, or (3.57) per share (basic and diluted), compared to a net loss of 23.2 million, or (3.95) per share (basic and diluted) for the full year in 2015. The loss for the full year 2016 includes a non-cash charge of 19.2 million for the accounting impact of a financial derivative related to the obligation to deliver shares to Incyte in 2017.
Merus ended the 2016 full year with cash and cash equivalents of 56.9 million. On January 23, 2017, the Company closed its global strategic
research collaboration with Incyte Corporation, which included an upfront payment of $120 million and the purchase by Incyte of 3.2 million of Merus common shares for $80 million.
MCLA-128 is designed to block HER3/heregulin dependent tumor growth and survival as well as enhance immune-mediated killing of tumors. MCLA-128 employs a dock and
block mechanism in which the mode of HER2 receptor binding orientates the HER3 binding arm to effectively block oncogenic signaling through the HER2:HER3 heterodimer even under high heregulin concentrations. In addition, MCLA-128 is engineered for enhanced ADCC in order to recruit and activate immune effector cells to directly kill the tumor.
MCLA-117 is a Biclonics that is 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.
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.
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 being
evaluated in a Phase 1/2 clinical trial in Europe as a potential treatment for HER2-expressing solid tumors. 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, and Biclonics designed to bind to various combinations of immunomodulatory molecules,
including PD-1 and PD-L1.
Forward Looking Statement
Except for the historical information set forth herein, this press release contains predictions, estimates and other forward-looking statements, including
without limitation statements regarding: the impact of our collaboration with Incyte on the clinical development of our bispecific antibody candidates, anticipated clinical data points for 2017, the timing of presentations, clinical data
announcements, and regulatory filings, the potential payments under our collaboration agreement with Incyte, each statement under Anticipated Milestones, and the treatment potential of our bispecific antibody candidates.
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 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 bispecific antibody candidates under our collaboration with Incyte or Incyte may fail to perform adequately under our
collaboration; and our reliance on third parties to manufacture our product candidates, which may delay, prevent or impair our development and commercialization efforts.
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.
Consolidated Statement of Financial Position
December 31, 2016 December 31, 2015
(euros in thousands, unaudited)
Non-current assets
Property, plant and equipment 648 325
Intangible assets 374 435
Restricted cash 167 218
1,189 978
Current assets
Financial asset 11,847
Trade and other receivables 2,357 1,665
Cash and cash equivalents 56,917 32,851
71,120 34,516
Total assets 72,310 35,494
Shareholders equity
Issued and paid-in capital 1,448 775
Share premium account 139,878 90,909
Accumulated loss (107,295 ) (63,382 )
Total equity 34,031 28,302
Non-current liabilities
Borrowings 319 486
Deferred revenue 30,206 390
Current liabilities
Borrowings 167 167
Trade payables 2,298 2,419
Taxes and social security liabilities 29 142
Deferred revenue 1,610 223
Other liabilities and accruals 3,650 3,365
7,754 6,316
Total liabilities 38,280 7,192
Total equity and liabilities 72,310 35,494
Consolidated Statement of Profit or Loss and Comprehensive Loss
Three months ended Year ended
December 31, 2016 December 31, 2015 December 31, 2016 December 31, 2015
(euros in thousands, except per share data, unaudited)
Revenue (408 ) 373 2,719 1,977
Research and development costs (6,268 ) (4,844 ) (18,991 ) (16,350 )
Management and administration costs (3,123 ) (368 ) (4,258 ) (768 )
Other expenses (2,539 ) (1,835 ) (7,142 ) (7,898 )
Total operating expenses (11,930 ) (7,047 ) (30,391 ) (25,016 )
Operating result (12,338 ) (6,674 ) (27,672 ) (23,039 )
Finance income 14 36 88 50
Finance costs (19,623 ) (8 ) (19,644 ) (195 )
Total finance income (expenses) (19,609 ) 28 (19,556 ) (145 )
Result before tax (31,947 ) (6,646 ) (47,228 ) (23,184 )
Income tax expense
Result after taxation (31,947 ) (6,646 ) (47,228 ) (23,184 )
Exchange differences from translation of foreign operations 5 8
Other comprehensive income 5 8
Total comprehensive loss (31,942 ) (6,646 ) (47,220 ) (23,184 )
Basic (and diluted) loss per share (1.99 ) (0.77 ) (3.57 ) (3.95 )
Last updated: Apr 28, 2017