Nasdaq GlobeNewswire

Merus Announces Third Quarter 2017 Financial Results and Clinical Highlights

Del

UTRECHT, The Netherlands, Nov.  30, 2017  (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq:MRUS), a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics (Biclonics®), today announced financial results for the third quarter ended September 30, 2017 and provided a clinical update.

"Merus continues to make meaningful advances with both our proprietary pipeline, led by MCLA-128, and our various collaboration programs," said Ton Logtenberg, Ph.D., Chief Executive Officer of Merus. "We look forward to several milestones over the balance of the year, including our plan to initiate a Phase 2 clinical trial of MCLA-128 in combination with other therapies in HER2 positive and ER+/HER2 low metastatic breast cancer and plan to file a Clinical Trial Application ("CTA") for a first-in-human clinical trial of MCLA-158 in patients with colorectal cancer. Our Phase 1/2 clinical trial evaluating single agent activity for MCLA-128 in gastric, ovarian, endometrial and non-small cell lung (NSCL) cancers is ongoing and we anticipate defining the clinical plan for MCLA-128 for additional solid tumors in early 2018. Also in 2018, we intend to continue to advance MCLA-117 in the clinic for acute myeloid leukemia (AML) and progress MCLA-145, being developed in collaboration with Incyte."

"We are committed to unlocking the full potential of our Biclonics®-based bispecific antibody platform, and we anticipate 2018 will be an important year for advancing multiple programs in the clinic," added Dr. Logtenberg.

Upcoming Milestones

MCLA-128, an enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) Biclonics ® that binds to HER2 and HER3-expressing solid tumor cells

Merus intends to initiate a Phase 2 clinical trial of MCLA-128 in combination with other therapies in HER2 positive and ER+/HER2 low metastatic breast cancer by the end of 2017. In early 2018, Merus expects to formulate its clinical development plans in gastric, ovarian, endometrial and NSCL cancers based on a data readout from its ongoing Phase 1/2 clinical trial.

MCLA-117, a Biclonics ® that binds to CD3 and CLEC12A

Merus is continuing its dose escalation of the Phase 1 clinical trial for MCLA-117 in Europe, and expects to submit an Investigational New Drug application to the U.S. Food and Drug Administration in the first half of 2018.

MCLA-158, an ADCC-enhanced Biclonics ® designed to bind to cancer stem cells expressing Lgr5 and EGFR

Merus expects to file a CTA for a first-in-human clinical trial of MCLA-158 in patients with colorectal cancer by the end of 2017.

MCLA-145, a Biclonics ® designed to bind to PD-L1 and a second non-disclosed immunomodulatory target

Merus and Incyte are conducting an IND-enabling study for MCLA-145, the first drug candidate co-developed under their global research collaboration. Merus has full rights to develop and commercialize MCLA-145 in the United States and Incyte is responsible for its development and commercialization outside the United States.

Third Quarter 2017 Financial Results

Merus ended the third quarter of 2017 with cash and cash equivalents of €202.4 million compared to €56.9 million at December 31, 2016.

Total revenue for the three months ended September 30, 2017 was €3.5 million compared to €1.2 million for the same period in 2016. Revenue is comprised primarily of cost reimbursements, amortization of the Incyte upfront license payment, research funding and income from grants on research projects.

Research and development costs for the three months ended September 30, 2017 were €8.0 million compared to €4.1 million for the same period in 2016. The increase in research and development costs reflects higher enrollment in our clinical trials and expansion of research efforts to support our internal programs and collaboration with Incyte.

For the three months ended September 30, 2017, Merus reported a net loss of €15.7 million, or a loss of €0.81 per basic and diluted share, compared to a net loss of €4.9 million, or a loss of €0.31 per basic and diluted share, for the same period in 2016. The net loss for the three months ended September 30, 2017 includes approximately €5.5 million of foreign currency losses and approximately €2.7 million of non-cash, share option expenses.

Financial Outlook

Based on current operating plans, Merus expects that its current cash and cash equivalents balance will be sufficient to fund its research and development programs and operations well into 2019.

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 studies to have similar features as conventional 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 Europe in gastric, ovarian, endometrial and non-small cell lung cancers. Merus' second most advanced 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, as well as MCLA-145, which is designed to bind to PD-L1 and a non-disclosed second immunomodulatory target and is being developed in collaboration with Incyte Corporation. 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 statements regarding the timing of initiating the Phase 2 combination clinical trial of MCLA-128 and defining the clinical development plan for MCLA-128 in additional solid tumors, clinical development plans for MCLA-117, the timing of filing a Clinical Trial Application for MCLA-158 for a clinical trial in patients with colorectal cancer, the progress of developing MCLA-145 with Incyte, 2018 being an important period for advancing multiple clinical programs, each statement under "Upcoming Milestones," and the sufficiency of our cash and cash equivalents.

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 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.

Merus N.V.
Unaudited Condensed Consolidated Statement of Financial Position
(after appropriation of result for the period)
 
     
  September 30,
2017
 
December 31,
2016  
  (euros in thousands)
Non-current assets    
Property, plant and equipment   1,008   648
Intangible assets   328   374
Restricted cash   -    167
Other assets   123   109
    1,459   1,298
     
Current assets    
Financial asset   -    11,847
Trade receivables and other current assets   4,062   2,248
Cash and cash equivalents   202,424   56,917
    206,486   71,012
Total assets   207,945   72,310
     
Shareholders' equity    
Issued and paid-in capital   1,747   1,448
Share premium account   213,551   139,878
Accumulated loss   (155,553)   (107,295)
Total equity   59,745   34,031
Non-current liabilities    
Borrowings   -    319
Deferred revenue, net of current portion   131,903   30,206
Current liabilities    
Borrowings   -    167
Trade payables   2,837   2,298
Taxes and social security liabilities   242   29
Deferred revenue   7,052   1,610
Other liabilities and accruals   6,166   3,650
    16,297   7,754
Total liabilities   148,200   38,279
Total equity and liabilities   207,945   72,310
     

 

Unaudited Condensed Consolidated Statement of Profit or Loss and Comprehensive Loss
 
         
  Three months ended
September 30,
 
Nine months ended
September 30,
 
  (euros in thousands, except per share data) 
  2017  2016  2017  2016 
Revenue   3,471    1,182    9,784    3,127 
Research and development costs   (8,040)   (4,074)   (23,075)   (11,924)
Management and administration costs   (3,634)   (546)   (11,432)   (1,560)
Other expenses   (2,180)   (1,522)   (6,588)   (4,977)
Total operating expenses   (13,854)   (6,142)   (41,095)   (18,461)
Operating result   (10,383)   (4,960)   (31,311)   (15,334)
Finance income   254    25    864    74 
Finance costs   (5,519)   (10)   (28,215)   (21)
Total finance (expense) / income   (5,265)   15    (27,351)   53 
Result before taxation   (15,648)   (4,945)   (58,662)   (15,281)
Income tax expense   (64)   -    (181)   - 
Result after taxation   (15,712)   (4,945)   (58,843)   (15,281)
Other comprehensive income        
Exchange differences on the translation of foreign operations   33    3    51    3 
Total other comprehensive income for the period   33    3    51    3 
Total comprehensive loss for the period   (15,679)   (4,942)   (58,792)   (15,278)
Basic (and diluted) loss per share   (0.81)   (0.31)   (3.08)   (1.24)
Weighted average shares outstanding        
Basic (and diluted)   19,402,667    16,085,851    19,120,081    12,293,405

Contacts:

Media:

Eliza Schleifstein
+1 973 361 1546
eliza@argotpartners.com

Investors:

Kimberly Minarovich
+1 646 368 8014
kimberly@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 Nasdaq GlobeNewswire

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

+1 212 401 8700http://www.nasdaqomx.com

NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.

Følg saker fra Nasdaq GlobeNewswire

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

Siste saker fra Nasdaq GlobeNewswire

WillScot Announces Closing of Warrant Exchange Offer11.12.2018 22:05Pressemelding

BALTIMORE, Dec. 11, 2018 (GLOBE NEWSWIRE) -- WillScot Corporation (“WillScot”) (NASDAQ: WSC), the specialty rental services market leader providing innovative modular space and portable storage solutions across North America, today announced the closing of its previously announced exchange offer (the “Exchange Offer”) relating to certain outstanding warrants issued in 2015 (the “Warrants”). Under the terms of the Exchange Offer, each Warrant holder had the opportunity to receive 0.18182 shares of WillScot Class A Common Stock, par value $0.0001 per share (“Common Stock”), for each Warrant tendered by the holder and exchanged pursuant to the Exchange Offer. As of the closing of the Exchange Offer on December 11, 2018, 45,131,827 outstanding Warrants were properly tendered and not withdrawn in the Exchange Offer. 45,031,827 of the Warrants tendered were public warrants, representing approximately 89% of the public warrants, and approximately 100,000 Warrants tendered were private warrant

DoubleVerify and InMobi Unite to Combat Mobile App Fraud11.12.2018 18:02Pressemelding

Partnership brings mobile app fraud prevention to advertisers globally NEW YORK, Dec. 11, 2018 (GLOBE NEWSWIRE) -- DoubleVerify ("DV"), the leading independent provider of marketing measurement software and analytics, today announced a partnership with InMobi, a global provider of enterprise platforms for marketers. As part of the partnership, DoubleVerify will provide always-on fraud filtering and measurement for mobile in-app advertising campaigns across the InMobi Exchange globally. The integration with InMobi covers pre-bid targeting for all InMobi Exchange impressions within the leading mobile in-app platform, as well as monitoring of post-bid fraud activity, such as spoofing – enabling InMobi to continuously refine the quality of its mobile ad inventory. “DV’s partnership with InMobi demonstrates our commitment to provide consistent, comprehensive quality coverage for global brand advertisers,” said Matt McLaughlin, COO at DoubleVerify. “With ad spend increasingly concentrated in

Claroty Announces Major Enhancements to Market-Leading Industrial Cybersecurity Platform11.12.2018 15:00Pressemelding

Groundbreaking multispectral data acquisition and network segmentation capabilities provide deeper OT network visibility and reduce risk for industrial enterprises and critical infrastructure providers NEW YORK, Dec. 11, 2018 (GLOBE NEWSWIRE) -- Claroty, the leader in operational technology (OT) network protection, today announced several significant enhancements to its award-winning Continuous Threat Detection product and technology integrations with several leading industrial automation, network infrastructure and cybersecurity providers. Already the industry’s most complete industrial control systems (ICS) cybersecurity platform, this release incorporates new functionality to provide even more “extreme” visibility into ICS networks and help industrial enterprises decrease the risk of a cyberattack. The latest release of Claroty Continuous Threat Detection provides a large number of significant enhancements including: Virtual Zones and OT Network Segmentation – an innovative approach

INN Launches Battery Metals Channel11.12.2018 15:00Pressemelding

The new battery metals channel is designed to educate investors with original content and expert insight on the growing battery metals industry. VANCOUVER, British Columbia, Dec. 11, 2018 (GLOBE NEWSWIRE) -- Investing News Network (INN) announces the launch of its battery metals channel. Responding to the growth and evolution of the battery metals market, this channel will host news, educational content and expert opinions on the lithium, cobalt, graphite, vanadium and manganese market segments. “INN has been a trusted source of information on the lithium, cobalt, graphite, vanadium and manganese markets for nearly a decade, and is excited to bring these sectors together under the battery metals umbrella,” said Nick Smith, CEO and publisher at INN. “Through connections with experts, our leading team of experienced writers creates original, insightful content on battery metals. INN educates investors in the industry by providing information they may never have access to on their own,” S

Galimedix Therapeutics Appoints Industry Veteran, Hermann Russ, M.D., Ph.D., Chief Scientific Officer11.12.2018 14:30Pressemelding

KENSINGTON, Md. and SHORASHIM, Israel, Dec. 11, 2018 (GLOBE NEWSWIRE) -- Galimedix Therapeutics, which is developing new solutions for ophthalmic and neurodegenerative diseases, announced the appointment of Hermann Russ, M.D., Ph.D., as its chief scientific officer, effective December 1, 2018. Dr. Russ invented the use of the company’s lead molecule GAL-101/MRZ-99030 for the treatment of degenerative diseases of the retina, including glaucoma and dry macular degeneration. He is also co-inventor of the so-called “trigger effect” of GAL-101/MRZ-99030 and GAL-102/MRZ 14042, which is a unique reverse prion-like self-propagation mechanism of action important for the company’s eye drop and oral treatment regimens. “We are gratified that Dr. Russ is joining the Galimedix management team, as his knowledge in the field, as well as intimate experience with the compound, have already proven instrumental in the development of our company to date,” commented Andrew Pearlman, Ph.D., CEO of Galimedix

Farmako: Cannabis distributor to become gateway to Europe11.12.2018 10:00Pressemelding

Company is first to apply for a licence in the United Kingdom AAA-Team pushes to become gateway to Europe Company first to apply for distribution licences in UK Support of Canadian LP to obtain EU-GMP Focus on research and development FRANKFURT, Germany, Dec. 11, 2018 (GLOBE NEWSWIRE) -- The Frankfurt-based pharmaceutical company Farmako is a research-based pharmaceutical company that distributes medical cannabis. The company is active in all European markets that have created a legal basis for cannabinoid therapies. It is the first company for medical Cannabis pursue distribution licences in multiple European countries. Fort hat, it will rely on EU-GMP certified suppliers. The German market for medical cannabis is estimated at 19.1 million euros in 2018 and at 200 million Euros by 2019. For 2028, experts expect a market volume for medical cannabis of 7.8 billion euros in Germany, an increase by a factor of 400. The number of patients for cannabinoid therapies in Germany has grown from

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom