Merus N.V. : Merus Announces Recent Corporate Developments and Financial Results for the First Quarter 2018


- Initiation of Phase 1, first-in-human clinical trial of MCLA-158 in patients with solid tumors -

- MCLA-128's unique mechanism of action published in the scientific journal Cancer Cell -

UTRECHT, The Netherlands, July 26, 2018 (GLOBE NEWSWIRE) --  Merus N.V. (Nasdaq:MRUS) ("Merus", "we", "our" or the "Company"), a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics (Biclonics®), today announced financial results for the first quarter ended March 31, 2018 and provided a corporate and clinical update.

"In May, we advanced MCLA-158, a Biclonics® designed to bind to cancer-initiating cells expressing Lgr5 and EGFR, into the clinic with the commencement of patient dosing in a Phase 1, first-in-human clinical trial in patients with solid tumors," said Ton Logtenberg, Ph.D., Chief Executive Officer of Merus. "Clinical trials for MCLA-128 and MCLA-117 are ongoing. Potential early activity data for MCLA-117 is expected in 2018, and we anticipate reporting data for MCLA-128 later this year."

Dr. Logtenberg continued, "Notably, the unique mechanism of action of MCLA-128 was recently published in the scientific journal Cancer Cell and highlighted the screening of a panel of more than 500 bispecific antibodies binding to the HER2/HER3 target pair in relevant functional assays. This unbiased functional screening led to the identification of development candidate MCLA-128, a bispecific antibody that employs a unique mechanism, DOCK & BLOCK®, for the selective and potent inhibition of the heregulin/HER3 tumor-signaling pathway. These results reinforce the potential of our functional screening process that allows for the discovery of unique biology driven by the bispecific antibody format." 

Recent Clinical & Corporate Developments

  • Patient Dosing Commenced in a Phase 1 Clinical Trial of MCLA-158 in Patients with Solid Tumors - Merus announced in May 2018 that the first patient was dosed in a Phase 1, first-in-human clinical trial of MCLA-158 in patients with solid tumors with an initial focus on metastatic colorectal cancer. The trial consists of two parts, a dose escalation and a dose expansion. The dose escalation part is intended to determine the appropriate dose of MCLA-158. The dose escalation and expansion parts of the trial will also examine the preliminary antitumor activity of single-agent MCLA-158. 
  • DOCK & BLOCK® Mechanism of Action (MOA) of MCLA-128 Published in Cancer Cell  -The MOA of MCLA-128, the Company's most-advanced Biclonics® candidate that binds to HER2 and HER3-expressing solid tumor cells and potently blocks the heregulin/HER3 tumor-signaling pathway, was published in the May 2018 edition of Cancer Cell titled, "Unbiased Combinatorial Screening Identifies a Bispecific IgG1 that Potently Inhibits HER3 Signaling via HER2-Guided Ligand Blockade." Using a structure function approach, Merus demonstrated that PB4188, the research candidate described in the paper, employs a unique mechanism to inhibit the growth of tumors by docking to HER2 and blocking ligand interaction with HER3, thereby preventing stabilization of the HER2:HER3 heterodimer and sustained signaling. MCLA-128, the development candidate of PB4188, is currently being studied in a Phase 2 combination trial in two metastatic breast cancer populations and a Phase 1/2 study evaluating single-agent activity for MCLA-128 in gastric, ovarian, endometrial and non-small cell lung cancer (NSCLC). 
  • Awarded Fees and Costs in Regeneron Patent Litigation - On June 25, 2018, in a decision which published on July 10, 2018, the United States District Court for the Southern District of New York granted Merus' motion for approximately $10.5 million of attorneys' fees, expert fees and costs, plus pre- and post-judgment interest, incurred by Merus in its defense of Regeneron Pharmaceutical Inc.'s suit initiated in March 2014. The District Court's decision recounts Regeneron's inequitable conduct before the United States Patent and Trademark Office while prosecuting the U.S. Patent No. 8,502,018 (the '018 patent), entitled "Methods of Modifying Eukaryotic Cells."

Anticipated 2018 Milestones

MCLA-128, an antibody-dependent cell-mediated cytotoxicity (ADCC) enhanced Biclonics® that binds to HER2 and HER3-expressing solid tumor cells 
The Phase 1/2 study evaluating single-agent activity for MCLA-128 in various solid tumor indications is ongoing and Merus expects to provide an update on the gastric cohort in the fourth quarter of 2018.

MCLA-117, a Biclonics® that binds to CD3 and CLEC12A 
Merus is continuing dose escalation in the Phase 1 clinical trial of MCLA-117 in Europe and the U.S. Safety and potential early activity data is expected in the second half of 2018.

MCLA-158, an ADCC-enhanced Biclonics® designed to bind to cancer stem cells expressing Lgr5 and EGFR 
Recruitment for the Phase 1 clinical trial of MCLA-158 in patients with solid tumors is ongoing. The trial is being conducted in Europe and the U.S.

MCLA-145, a Biclonics® designed to bind to PD-L1 and a second undisclosed immunomodulatory target 
MCLA-145, the first drug candidate co-developed under the Merus and Incyte global research collaboration, continues to progress in IND-enabling studies. Merus has full rights to develop and commercialize MCLA-145 in the U.S. and Incyte is responsible for its development and commercialization outside the U.S.

First Quarter 2018 Financial Results

Merus ended the first quarter of 2018 with cash, cash equivalents and investments of €220.1 million compared to €190.8 million at December 31, 2017, the increase primarily being the result of the closing of a $55.8 million (€44.8 million) private placement of 3.1 million common shares completed in February 2018.

Total revenue for the three months ended March 31, 2018 was €9.9 million compared to €3.9 million for the same period in 2017. Revenue for the three months ended March 31, 2017 has been restated for the adoption of IFRS 15, a new accounting standard related to revenue recognition. Under IFRS 15, Merus reduced the period that it amortizes revenue for the upfront license payment received from Incyte from 21 years to 9 years which resulted in €1.6 million of additional revenue for the three months ended March 31, 2017. Revenue is comprised primarily of the amortization of upfront license payments from Merus' collaboration agreements and collaboration income related to cost reimbursements and research milestones for performance of research and development services under the respective agreements.

The increase in revenue for the period is attributable to €1.9 million of amortization of upfront license payments, €1.6 million of collaboration income for expense reimbursements and €2.5 million for research milestones earned under Merus' agreement with Ono Pharmaceuticals.  

Research and development costs for the three months ended March 31, 2018 were €10.3 million compared to €7.0 million for the same period in 2017. The increase in research and development costs reflects higher enrollment in Merus' clinical trials, expansion of research efforts to support its internal programs and collaborations and additional manufacturing expenses.

Management and administration costs for the three months ended March 31, 2018 were €2.9 million compared to €4.2 million for the same period in 2017. The decrease relates primarily to lower share-based compensation expenses.  

Other expenses for the three months ended March 31, 2018 were €2.7 million compared to €1.8 million for the same period in 2017. The increase in other expenses was the result of higher consulting, accounting and professional fees.

For the three months ended March 31, 2018, Merus recorded a net loss of €8.4 million, or €(0.40) per share (basic and diluted), compared to a net loss of €19.7 million, or €(1.06) per share (basic and diluted), for the same period in 2017. The net loss for the three months ended March 31, 2017 included 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.

Financial Outlook

Based on the Company's current operating plan, Merus expects that its existing cash, cash equivalents and investments will be sufficient to fund its operations through the end of 2020.

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 and clinical studies to have several of the same features of conventional human 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 gastric, ovarian, endometrial and non-small cell lung cancers. Additional pipeline programs include MCLA-117, which is currently being studied in a Phase 1 clinical trial in patients with acute myeloid leukemia, and MCLA-158, a Biclonics® being studied in a Phase 1 clinical trial in patients with solid tumors with an initial focus on metastatic colorectal cancer. Through its collaboration with Incyte Corporation, Merus is also developing a preclinical bispecific antibody designed to bind to PD-L1 and a non-disclosed second immunomodulatory target. For additional information, please visit Merus' website,

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 the formulation of clinical development plans and clinical development of our bispecific antibody candidates, anticipated clinical data points for 2018, the timing of expected patient recruitment and dosing, presentations, clinical data announcements, and the advancement of the Phase 2 combination trial for MCLA-128, the potential of our functional screening process, each statement under "Anticipated Milestones," the sufficiency of our cash, cash equivalents and investments, and the design and treatment potential of our bispecific antibody candidates including MCLA-128, MCLA-117, MCLA-158 and MCLA-145.

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 30, 2018, 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.


Unaudited Consolidated Statement of Financial Position

  March 31,
December 31,
2017 Restated*  
  (euros in thousands)
Non-current assets          
Property, plant and equipment   1,139       1,168  
Intangible assets   297       312  
Non-current investments   15,758       7,060  
Other assets   137       129  
    17,331       8,669  
Current assets          
Taxes and social security assets   924       -  
Trade and other receivables   11,473       4,413  
Current investments   39,869       34,043  
Cash and cash equivalents   164,492       149,678  
    216,758       188,134  
Total assets   234,089       196,803  
Shareholders' equity          
Issued and paid-in capital   2,036       1,749  
Share premium account   258,109       213,618  
Accumulated loss   (164,778 )     (158,775 )
Total equity   95,367       56,592  
Non-current liabilities          
Deferred revenue   109,736       112,551  
Current liabilities          
Trade payables   5,221       2,855  
Taxes and social security liabilities   240       243  
Deferred revenue   17,286       15,935  
Other liabilities and accruals   6,239       8,627  
    28,986       27,660  
Total liabilities   138,722       140,211  
Total equity and liabilities   234,089       196,803  

*Accumulated loss and deferred revenue (current and non-current) have been restated for the impact of the adoption of IFRS 15, an accounting standard related to revenue recognition, by decreasing accumulated loss and net deferred revenue by a total of €8.7 million at December 31, 2017.

Unaudited Consolidated Statement of Profit or Loss and Comprehensive Loss

   Three months ended March 31,
  2018     2017 Restated**
  (euros in thousands, except per
share data)
Revenue 9,921       3,884  
Research and development costs (10,298 )   (7,007 )
Management and administration costs (2,852 )   (4,202 )
Other expenses (2,686 )   (1,843 )
Total operating expenses (15,836 )   (13,052 )
Operating result (5,915 )   (9,168 )
Finance income 340     190  
Finance costs (2,806 )   (10,734 )
Net finance expense (2,466 )   (10,544 )
Result before tax (8,381 )   (19,712 )
Income tax expense (52 )   (11  )
Result after taxation (8,433 )   (19,723 )
Exchange differences from translation of foreign operations (15 )   5  
Other comprehensive (loss) / income for the period (15 )   5  
Total comprehensive loss for the period (8,448 )   (19,718 )
Basic (and diluted) loss per share (0.40 )   (1.06 )
Basic (and diluted) 20,984,663     18,555,775  

** Revenue for the three months ended March 31, 2017 has been restated to reflect additional revenue of €1.6 million, or €0.09 per share, related to the amortization of the up-front license payment received from Incyte due to the impact of the adoption of IFRS 15, an accounting standard related to revenue recognition.


Kimberly Minarovich 
+1 646-368-8014

David Rosen 
+1 212-600-1902

This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Merus N.V. via Globenewswire

Om GlobeNewswire

One Liberty Plaza - 165 Broadway
NY 10006 New York

GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Følg saker fra GlobeNewswire

Registrer deg med din epostadresse under for å få de nyeste sakene fra GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra GlobeNewswire

Appian Named A Leader in Digital Process Automation for Deep Deployments Report by Independent Research Firm19.6.2019 16:28:00 CESTPressemelding

RESTON, Va, June 19, 2019 (GLOBE NEWSWIRE) -- Appian (NASDAQ: APPN) today announced it has been named a leader in “The Forrester Wave™: Software For Digital Process Automation For Deep Deployments, Q2 2019” report (“DPA Deep”). In Forrester’s four market segments for rapid application development, DPA Deep platforms “excel at the high end of process complexity but may also be the right solution to meet the needs for a wide-deployment, low-code standard” in an organization. In Forrester’s evaluation, Appian tied for the top score in the Current Offering category (including criteria for user experience development tools; process and flow design; digital decisioning, and robotic process automation). Appian also received among the second-highest scores in the Strategy category (including criteria like vision and strategy, commercial model, partners and training, community, and marketplace). The report notes that “Appian is a low-code vendor that thrives in complex process environments.” Th

Seaborn Networks announces new IP & Ethernet Services for Brazil and U.S. market19.6.2019 14:30:00 CESTPressemelding

BOSTON, June 19, 2019 (GLOBE NEWSWIRE) -- Seaborn Networks (“Seaborn”), a leading developer-owner-operator of subsea fiber optic cable systems, today announced that it will be delivering industry leading performance with new IP Service offerings comprising of diverse Ethernet Service and IP Service solutions addressing the market’s demand for rapidly deployed and highly stable global Ethernet & IP based needs between North and South America. IP Service offerings will include IP Transit, Remote Peering, Cloud Connect and Enterprise DIA solutions. Seaborn’s IP Services are offered under a minimal commitment with the ability to utilize additional bandwidth on a pay-as-you-use basis. Seaborn’s Ethernet Service offerings include E-Line, E-LAN and E-Tree capabilities with options for protected service depending on the Class of Service (CoS) selected. Industry leading SLA’s are provided on all IP and Ethernet services. “In today’s fast paced, highly complex communications environment, busines

Standard Lithium Announces Positive Preliminary Economic Assessment and Upgrading of Mineral Resource at Its Southern Arkansas Lithium Brine Project19.6.2019 09:00:00 CESTPressemelding

VANCOUVER, British Columbia, June 19, 2019 (GLOBE NEWSWIRE) -- Standard Lithium Ltd. (“Standard Lithium” or the “Company”) (TSXV: SLL) (OTCQX: STLHF) (FRA: S5L), is pleased to announce the results of a Preliminary Economic Assessment (PEA) of its 150,000 acre project in the south-central region of Arkansas, USA (the “Property”). The PEA considers the production of battery-quality lithium carbonate through a phased build-out to a total 20,900 tonnes per annum (tpa) from the contemplated joint venture with Lanxess Corp. (see press release dated November 12, 2018) at their three-operating bromine-processing plants. The PEA also includes the reclassification of the existing mineral resource to an Indicated category. The PEA was prepared by Advisian, the consulting arm of WorleyParsons Canada Services Ltd (Worley), a world-leading integrated engineering firm with extensive experience in the design and construction of chemical plants and lithium brine processing projects around the globe. Ke

Data Privacy and Governance Solution Now Cloud-based18.6.2019 18:34:00 CESTPressemelding

HIPAAT Privacy eSuite adds support for Consent as a Service, enabling consumers to have direct control over their personal information NAPLES, FL and TORONTO, ON, June 18, 2019 (GLOBE NEWSWIRE) -- HIPAAT Inc. (HIPAAT), a leading provider of consent management, privacy-based access control and auditing solutions, today announced the release of version 6.0 of its consent engine, Privacy eSuite (PeS). The new version supports consumers’ ability to have direct control over their personal information privacy preferences. Those preferences may be recorded and managed, and – most importantly – consulted prior to their information being collected, used or disclosed. V6.0 improvements include support for HL7 Fast Health Interoperability Resources (FHIR) R4 for managing privacy policies and consent directives, RESTful interfaces for consent decisions and override requests, OAuth 2.0 protection for APIs as resources, and Open ID Connect and OAuth 2.0 for authenticating users and providing user pe

Boom Supersonic Partners with Prometheus Fuels to Supply Carbon Neutral Fuel for XB-1, its Mach-2.2 Demonstrator Aircraft18.6.2019 17:00:00 CESTPressemelding

Prometheus Fuels extracts CO2 from the air, creating hydrocarbon fuel with zero impact on greenhouse gas levels DENVER, June 18, 2019 (GLOBE NEWSWIRE) -- Boom Supersonic, the Colorado company building history’s fastest supersonic airliner, today announced a unique partnership with Prometheus Fuels. Prometheus will supply fuel during the flight test program of XB-1, Boom’s Mach-2.2 demonstrator aircraft. Boom plans to use Prometheus fuel to power XB-1 in the world’s first supersonic flight using carbon-neutral fuel. Through a process called direct air carbon capture, Prometheus removes carbon dioxide (CO2) from the air and uses clean electricity to transform it into gasoline, diesel, and jet fuel. The electricity used in this process comes from renewable sources such as solar and wind, so there are no net carbon emissions from using the fuel. “Boom is committed to making supersonic travel environmentally sustainable—we want society to enjoy the benefits of faster flight for generations

Parallels® Remote Application Server 17 Brings Simplicity and Scalability to End User Computing for Microsoft RDS, VDI and DaaS with Time-Saving Innovations18.6.2019 15:01:00 CESTPressemelding

BELLEVUE, Wash., June 18, 2019 (GLOBE NEWSWIRE) -- Today Parallels released version 17 of Parallels® Remote Application Server (Parallels RAS, which simplifies end user computing for service providers (SPs) and enterprises. Parallels RAS 17 enables faster launch of applications by using artificial intelligence (AI), provides additional security features such as integration with Google Authenticator, and debuts a web-based helpdesk console to more easily manage Microsoft Remote Desktop Services (RDS), virtual desktop infrastructure (VDI) and desktop as a service (DaaS) infrastructure. Parallels RAS 17 is an all-in-one solution that empowers end users to consume business applications faster, reliably, and with the ability to scale within a single cloud or multiple clouds. SPs and enterprises can benefit from the Parallels RAS investment in improved management and deployment components. These provide new methods to control DaaS, VDI and Microsoft RDS, such as a new REST