GlobeNewswire

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

Del

- 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, 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 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,
2018  
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.

Contacts:

Investors:
Kimberly Minarovich 
+1 646-368-8014
kimberly@argotpartners.com

Media:
David Rosen 
+1 212-600-1902
david.rosen@argotpartners.com




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

GlobeNewswire
GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://globenewswire.com

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

Magna Announces Fourth Quarter and 2018 Results and Raises Quarterly Cash Dividend by 11%22.2.2019 11:00:00Pressemelding

Fourth Quarter 2018 Highlights Record fourth quarter sales of $10.1 billion up 5% from the fourth quarter of 2017 Cash from operations of $1.6 billion Returned $585 million to shareholders through share repurchases and dividends Raised quarterly cash dividend by 11% to $0.365 per share Full Year 2018 Highlights Record sales of $40.8 billion, up 12% from 2017 Record diluted earnings per share of $6.61, an increase of 13% Record cash from operations of $3.7 billion Returned approximately $2.3 billion to shareholders through share repurchases and dividends AURORA, Ontario, Feb. 22, 2019 (GLOBE NEWSWIRE) -- Magna International Inc. (TSX: MG; NYSE: MGA) today reported financial results for the fourth quarter and year ended December 31, 2018. THREE MONTHS ENDED DECEMBER 31, YEAR ENDED DECEMBER 31, 2018 2017 (2) 2018 2017 (2) Reported Sales $ 10,137 $ 9,684 $ 40,827 $ 36,588 Income from operations before income taxes $ 607 $ 765 $ 2,951 $ 2,985 Net income attributable to Magna International I

IMImobile announces integration of WhatsApp Business solution into its enterprise cloud communications platform IMIconnect22.2.2019 10:37:00Pressemelding

The WhatsApp Business solution will be made available across its enterprise cloud communications platform IMIconnect allowing businesses to launch business-to-consumer communications on WhatsApp LONDON, Feb. 22, 2019 (GLOBE NEWSWIRE) -- Global cloud communications software and solutions provider IMImobile PLC, today announced the integration of the WhatsApp Business solution into its enterprise cloud communications platform IMIconnect. The WhatsApp Business solution enables businesses to connect with over 1.5 billion users in a simple, reliable, and private way across 180 countries worldwide. As a WhatsApp Business solution provider, the IMIconnect platform will enable enterprises to seamlessly integrate the WhatsApp Business solution into their customer communications strategies, and drive engagement through intelligent and context-aware messaging. “We are excited to announce the integration of the WhatsApp Business solution today in our IMIconnect platform. We understand that today’s

Nordic Innovators Cloudstreet and Domos Partner to Deliver an End-to-End, Application-Aware 5G Experience to the Home22.2.2019 09:00:00Pressemelding

Cloudstreet’s carrier-grade API and Network Slicing platform with Domos’ Machine Learning Solution for home networks delivers intelligent connectivity out of the box Barcelona, Spain., Feb. 22, 2019 (GLOBE NEWSWIRE) -- Finland’s Cloudstreet, the US-patented Network Slicing Company, and Norway’s Domos, a leader in Machine Learning technologies for the smart home, are pleased to announce that they have teamed up to create the industry’s first end-to-end, intelligent application and context-aware network slicing solution for home networks. The solution will be on display February 25-28 at the Mobile World Congress in Barcelona in Hall 5, stand 5C41. A perfect example of MWC’s aspirational theme, “Intelligent Connectivity”, the solution closes the loop on delivering a 5G experience to fixed wireless home networks. The combined technologies solve two key, last-mile problems that have plagued mobile-enabled home networks: 1) How to build application-awareness into the network without comprom

General Electric Company: Doc re. GE Files Form 8-K22.2.2019 08:00:00Pressemelding

FAIRFIELD, Conn., Feb. 22, 2019 (GLOBE NEWSWIRE) -- Company General Electric Company ISIN US3696041033 Symbol London: GEC | Paris: GNE Headline Doc re: GE files Form 8-K February 21, 2019 On February 21, 2019, General Electric Company (the "Company") filed a Form 8-K with the U.S. Securities and Exchange Commission ("SEC"), which has been submitted to RNS. It is also available on the SEC's website at http://www.sec.gov and on the Company's website at https://www.ge.com/investor-relations/events-reports. http://www.rns-pdf.londonstockexchange.com/rns/8048Q_1-2019-2-21.pdf CONTACT: GE Jennifer Erickson +001 646 682 5620 jennifer.erickson@ge.com This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit

Northland Power Reports Full Year and Fourth Quarter 2018 Results22.2.2019 02:52:00Pressemelding

Results Reflect Successful Growth Strategy with Free Cash Flow per Share Up 30% and Adjusted EBITDA Up 17% TORONTO, Feb. 21, 2019 (GLOBE NEWSWIRE) -- Northland Power Inc. (“Northland” or the “Company”) (TSX: NPI) today reported financial results for the three months and year ended December 31, 2018. “2018 was a significant year for Northland. We continued to operate safely and efficiently, achieving strong growth in free cash flow and adjusted EBITDA,” said Mike Crawley, President and Chief Executive Officer of Northland. “Construction of Deutsche Bucht project remains on time and on budget, and we also remain well-positioned for continued growth. Our expansion into Asia has gained further traction, with the first of the three Hai Long offshore wind projects securing all approvals and permits. The next step for this 300 MW project will be executing its PPA.” Highlights: 2018 Financial Results Sales increased 13% from $1.4 billion in 2017 to $1.6 billion and gross profit increased 17% t

NexusTours appoints Sham Ganiwalla as Business Development Director for Europe and Middle East21.2.2019 18:25:00Pressemelding

CANCUN, Mexico, Feb. 21, 2019 (GLOBE NEWSWIRE) -- NexusTours is pleased to announce that Sham Ganiwalla has joined the company as Business Development Director for the Europe and Middle Eastern markets. With a career spanning many years in tourism working for companies such as Tourico Holidays and Hotelbeds, Sham has extensive knowledge about different areas of the business, from product and marketing, to performance management and customer service. Reporting to Nadia Younes, Commercial Director Europe & MEAPAC, Sham will bring value to the development of Nexus' projects across the region. Rubén Gutiérrez, President Destination Services of Sunwing, commented, “The addition of Sham, will allow us to accelerate our commercial expansion in Europe and MEAPAC. We know that there are many travel partners that will value our expansion and positioning as regional leaders in destinations across America, our quality of service as “local experts”, as well as the ease of obtaining reservations thr