CORRECTING and REPLACING -- Merus Announces Fourth Quarter and Full Year 2016 Financial Results and Corporate Developments
In a release issued
Merus Announces Fourth Quarter and Full Year 2016 Financial Results and Corporate Developments
"Last year was a transformative period for Merus marked by the signing of a global collaboration with
March 2017, Merus announced that it was named BioCapital Europe Companyof the Year for 2017. The Company of the Year Award is given to the organization that has undergone the most substantial transformation in the previous year and has experienced a breakthrough with respect to its technology, clinical development, partnering, IPO and/or M&A activities.
January 2017, Merus and the Institute for Research in Biomedicine (IRB) Barcelona, a research center devoted to understanding fundamental questions about human health and disease, entered into a research collaboration to jointly develop novel agents that target the tumor microenvironment. The research collaboration will combine Merus’ Biclonics® technology platform for the discovery and development of therapeutic bispecific antibodies and IRB’s unique cell and animal models to evaluate therapeutic targeting of stromal cells that support tumor growth and metastasis.
December 2016, Merus and Incyte(NASDAQ:INCY) announced a global, strategic collaboration agreement focused on the research, discovery and development of bispecific antibodies utilizing Merus’ proprietary Biclonics® technology platform. The agreement grants Incytecertain exclusive rights for up to eleven bispecific antibody research programs, including two of Merus’ current preclinical immuno-oncology discovery programs. Under the terms of the collaboration, which closed in January 2017, Incytepaid Merus an upfront payment of $120 millionand purchased 3.2 million common shares of Merus at $25per share, for a total equity investment of $80 million. For one current preclinical program, Merus will retain all rights to develop and commercialize an approved product in the United States. Merus also has the option to co-fund development of product candidates arising from two other programs. For the other eight programs, Merus is eligible to receive potential development, regulatory and sales milestone payments of up to $350 millionper program, for an aggregate milestone opportunity of approximately $2.8 billionif all milestones are achieved across all eight programs in all territories, in addition to tiered royalties ranging from 6 to 10 percent on global sales.
November 2016, Merus received favorable rulings for its European patent EP 2147594 B1 by the Opposition Division of the European Patent Officeand by the Trial Board of the Japanese Patent Officefor its Japanese counterpart JP 5749161. Both patents cover Merus’ genetically-modified mice and their use to produce common light chain human monoclonal antibodies.
November 2016, Merus was awarded a grant of €0.5 million from EUREKA Eurostars with Aquila BioMedical Ltd.to jointly develop immunological assays supporting the selection of potent bispecific antibodies that positively modulate tumor immunity with superior potency and lower toxicity compared to existing drugs.
Anticipated 2017 Milestones
- Clinical data on MCLA-128 will be presented at the 2017 ASCO Annual Meeting taking place on
June 2-6, 2017in Chicago. The abstract is entitled, “First in human phase 1/2 study of MCLA-128, a full length IgG1 bispecific antibody targeting HER2and HER3; final phase 1 data and preliminary activity in HER2+ metastatic breast cancer (mBC).”
- An Investigational New Drug application to the U.S. Food and
Drug Administration of MCLA-117 for a Phase1 trial is planned during the second half of 2017.
- During the second half of 2017, Merus expects to report topline data from its Part 2 of Phase 1/2 monotherapy trial of MCLA-128 in patients with solid tumors in multiple indications.
- During the second half of 2017, Merus expects to report interim results from its Phase 1 clinical trial evaluating MCLA-117 in patients with AML.
- By the end of 2017, Merus expects to file a CTA for a planned Phase 1/2 clinical trial of MCLA-158 in patients with colorectal cancer.
Fourth Quarter 2016 Financial Results
(Euros in millions, except as indicated)
Total revenue for the three months ended
Research and development expenses for the three months ended
For the three months ended
Full Year 2016 Financial Results
(Euros in millions, 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
Merus ended the 2016 full year with cash and cash equivalents of €56.9 million. On
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.
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 being evaluated in a Phase 1/2 clinical trial in
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
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
These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 20-F filed with the
|Consolidated Statement of Financial Position|
|December 31, 2016||December 31, 2015|
|(euros in thousands, unaudited)|
|Property, plant and equipment||648||325|
|Trade and other receivables||2,357||1,665|
|Cash and cash equivalents||56,917||32,851|
|Issued and paid‑in capital||1,448||775|
|Share premium account||139,878||90,909|
|Taxes and social security liabilities||29||142|
|Other liabilities and accruals||3,650||3,365|
|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)|
|Research and development costs||(6,268||)||(4,844||)||(18,991||)||(16,350||)|
|Management and administration costs||(3,123||)||(368||)||(4,258||)||(768||)|
|Total operating expenses||(11,930||)||(7,047||)||(30,391||)||(25,016||)|
|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||)|
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