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.”
Recent Developments
- In March 2017, Merus announced that it was named BioCapital Europe Company of 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.
- In 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.
- In 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 Incyte certain 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, Incyte paid Merus an upfront payment of $120 million and purchased 3.2 million common shares of Merus at $25 per 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 million per program, for an aggregate milestone opportunity of approximately $2.8 billion if 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.
- In November 2016, Merus received favorable rulings for its European patent EP 2147594 B1 by the Opposition Division of the European Patent Office and by the Trial Board of the Japanese Patent Office for its Japanese counterpart JP 5749161. Both patents cover Merus’ genetically-modified mice and their use to produce common light chain human monoclonal antibodies.
- In 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, 2017 in 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 Phase 1 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 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
(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 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.
