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Merus Announces Financial Results for the Third Quarter 2019 and Provides Business Update

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UTRECHT, The Netherlands and CAMBRIDGE, Mass., Nov. 12, 2019 (GLOBE NEWSWIRE) -- Merus N.V. (NASDAQ:MRUS) ("Merus", "we", "our" or the "Company"), a clinical-stage company developing innovative, full-length bispecific antibodies (Biclonics®), today announced financial results for the third quarter ended September 30, 2019 and provided a business update.

"We are very encouraged by the recently reported early responses in patients treated with MCLA-128 whose tumor cells harbor an NRG1 fusion, a rare oncogenic driver, and believe the data offer further clinical validation of our Biclonics® platform," said Ton Logtenberg, Ph.D., President and Chief Executive Officer of Merus. "We remain focused on our plans to identify and recruit patients who may be amenable to MCLA-128 therapy, and to execute on all of our pipeline programs. We expect to provide additional meaningful clinical program updates in 2020." 

Clinical Programs and Business Update:

MCLA-128 (HER3 x HER2 Biclonics®): Early clinical activity presented in patients with pancreatic and lung cancers harboring NRG1 fusions; more mature data expected to be presented at a medical conference by end of 2020

On October 27, 2019, investigators from the Memorial Sloan Kettering Cancer Center presented early clinical activity of MCLA-128 ("zenocutuzumab", "zeno") in three patients with cancers harboring NRG1 fusions; Merus also disclosed information on six additional patients with cancers harboring an NRG1 fusion treated with MCLA-128.  

Of the aggregate nine NRG1 fusion patients who have been treated with MCLA-128 across the clinical trial and early access program, three were diagnosed with pancreatic ductal adenocarcinoma cancer (PDAC) and six with non-small cell lung cancer (NSCLC). All patients had previously progressed through standard of care and were identified through various diagnostic methods and investigator sites.  

  • Three patients (two PDAC, one NSCLC) treated with MCLA-128 with data presented by Memorial Sloan Kettering investigators responded with significant tumor shrinkage and symptomatic improvement and all currently remain on drug.  As of October 27, 2019: 
    • Two patients (one PDAC, one NSCLC) showed a partial response by RECIST 1.1 criteria.
    • One PDAC patient showed a stable disease by RECIST 1.1 criteria.
    • The two PDAC patients had been on treatment for greater than 7 months and the NSCLC patient for approximately 5 months; each remain on treatment.
  • Six additional patients with NRG1 fusions (one PDAC and five NSCLC) treated with MCLA-128 included:
    • One NSCLC patient had a stable disease with duration of 7 months before discontinuing due to poor adherence to treatment protocol (unrelated any adverse event or lack of efficacy).
    • One PDAC patient with a very advanced stage of disease was treated while in hospice care. MCLA-128 treatment was used as a last resort. The drug could not be delivered as intended and the patient passed away due to severe complications of the underlying disease prior to a first tumor evaluation.
    • Two NSCLC patients were in an advanced, rapidly progressive disease stage entering into MCLA-128 treatment and rapidly progressed.
    • Two NSCLC patients were recently enrolled and are too early on MCLA-128 treatment to be evaluated.

Merus plans to report on interim data from patients whose cancer cells harbor NRG1 fusions at a medical conference by the end of 2020, when more mature data, better characterization of the patient population and activity of MCLA-128 in a larger set of patients are expected to be available. Details of the eNRGy trial evaluating MCLA-128 in patients with NRG1 fusions, including current trial sites, can be found at ClinicalTrials.gov and Merus' trial website at nrg1.com.

MCLA-128 (HER3 x HER2 Biclonics®): Phase 2 Metastatic Breast Cancer interim analysis reported

In the Phase 2 Metastatic Breast Cancer trial, in patients enrolled as of August 31, 2019, Merus conducted an unplanned interim efficacy analysis with a data cut-off of October 23, 2019.  The company expects to present mature results, including the primary endpoint of clinical benefit rate at 24 weeks for both cohorts at a medical conference in 2020. Following the planned completion of the Phase 2 Metastatic Breast Cancer Trial, Merus will only advance development in metastatic breast cancer or gastric cancer with a collaborator. Merus intends to focus MCLA-128 program efforts on the eNRGy trial going forward.

MCLA-117 (CLEC12A x CD3 Biclonics®): Expect to present initial Phase 1 data at a medical conference 1H 2020  

Merus remains on track to present initial data at a medical conference in the first half of 2020.  In July 2019, Merus amended the MCLA-117 protocol to allow for the exploration of higher doses. The Phase 1 trial initiated at a low dose level based on the potent nature of T-cell engagers. Preliminary anti-tumor activity was reported in December 2018 and dose escalation for the Phase 1 clinical trial for MCLA-117 continues.

MCLA-158 (Lgr5 x EGFR Biclonics®): Initial safety data from Phase 1 trial expected at end of 2019, further guidance in 2020 

The dose escalation of the Phase 1 clinical trial of MCLA-158 in patients with solid tumors is progressing as planned. Emerging data for the Phase 1 trial, which will include safety and information around the recommended Phase 2 dose, is expected at the end of 2019. Merus plans to provide further guidance on the program in 2020. 

MCLA-145 (CD137 x PD-L1 Biclonics®): Phase 1 clinical trial progressing as planned

The Phase 1, open-label, single-agent clinical trial of MCLA-145 is ongoing and consists of dose escalation followed by dose expansion. Preclinical data has demonstrated that MCLA-145 has the potential to overcome known side effects of CD137 agonists currently in development. Merus is developing MCLA-145 as part of a collaboration with Incyte signed in December 2016 to potentially develop and commercialize up to 11 bispecific and monospecific antibodies from the Merus Biclonics® platform.

MCLA-129 (EGFR x c-MET Biclonics®): Pre-clinical data presented at medical conference October 2019  

On October 29, 2019, Merus presented pre-clinical data for the first time at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics.  MCLA-129 is an antibody-dependent cell-mediated cytotoxicity ("ADCC") -enhanced Biclonics® that inhibits the EGFR and c-MET signaling pathways in solid tumors. Preclinical data has shown that MCLA-129 reverses resistance to tyrosine kinase resistant non-small cell lung cancer (NSCLC) cell lines resulting in tumor growth inhibition in xenograft models of NSCLC. MCLA-129 is being developed in collaboration with Betta Pharmaceuticals ("Betta"), and is currently in IND-enabling studies.  Under the collaboration entered into in December 2018, Merus granted an exclusive license to Betta to develop and commercialize MCLA-129 in China and Merus has retained all rights outside of China.

Third Quarter 2019 Financial Results

Total revenue for the three months ended September 30, 2019 was €8.1 million compared to €6.5 million for the same period in 2018. Revenue is comprised primarily of the amortization of upfront license payments, R&D cost reimbursements, milestone payments for performance of R&D, and manufacturing services under our various collaboration agreements. The €1.6 million increase in revenue for the three months ended September 30, 2019 was primarily attributable to milestone revenue related to our license agreement with Ono.

Research and development costs for the three months ended September 30, 2019 were €12.8 million compared to €11.9 million for the same period in 2018. The increase in research and development costs reflects an increase in personnel-related costs and higher preclinical research and development-related costs.

Management and administration costs for the three months ended September 30, 2019 were €2.9 million compared to €2.7 million for the same period in 2018. The increase relates primarily to higher personnel-related expenses.

Other expenses for the three months ended September 30, 2019 were €4.4 million compared to €3.9 million for the same period in 2018. The increase in other expenses was the result of higher consulting, accounting and professional fees as well as higher facilities-related expenses.

For the three months ended September 30, 2019, Merus reported a net loss of €8.3 million, or €0.35 net loss per share (basic and diluted), compared to a net loss of €10.7 million, or €0.47 net loss per share (basic and diluted), for the same period in 2018. The net loss for the three months ended September 30, 2019 includes €3.1 million of foreign currency gains as compared to €0.9 million of foreign currency gains in the same period in 2018.

Merus ended the third quarter of 2019 with cash, cash equivalents and investments of €168.1 million compared to €205.5 million at December 31, 2018. The decrease was primarily the result of cash used in operations and purchases of property, plant and equipment, effects of exchange rate changes and interest received.

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 into 2022. The Company's outlook has been updated given the recent equity financing in November 2019 which provided gross proceeds of $79.2 million.


Unaudited Condensed Consolidated Statement of Financial Position

  September 30,
  December 31,
  2019    2018 
  (euros in thousands)
Non-current assets      
Property, plant and equipment, net 3,422     2,420  
Lease right-of-use assets 5,843     -  
Intangible assets, net 2,304     2,445  
Non-current investments 10,609     16,945  
Other assets 942     1,075  
  23,120     22,885  
       
Current assets      
Trade and other receivables 9,218     7,032  
Current investments 34,045     44,855  
Cash and cash equivalents 123,480     143,747  
  166,743     195,634  
Total assets 189,863     218,519  
       
Shareholders' equity      
Common share capital 2,107     2,102  
Common share premium 264,892     264,854  
Accumulated loss (196,624 )   (175,085 )
Total shareholders' equity 70,375     91,871  
       
Non-current liabilities      
Deferred revenue, net of current portion 85,361     97,675  
Other liabilities 4,463     -  
  89,824     97,675  
       
Current liabilities      
Trade payables 2,452     3,819  
Taxes and social security liabilities 183     256  
Deferred revenue 17,163     16,934
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