Merus Announces Financial Results for the First Quarter 2019 and Provides Business Update
“We had continued momentum in the first quarter following an active 2018,” said Ton Logtenberg, Ph.D., President, Chief Executive Officer and Principal Financial Officer of Merus. “This past month we announced the first patient treated in our fourth clinical program, MCLA-145, and presented promising pre-clinical data for the program at AACR. Merus is rapidly maturing; we are now a team of over 100 employees globally, committed to the execution of our clinical trials and the expansion of our technology. We remain on track to meet our expected milestones, and anticipate news across multiple programs by the end of 2019.”
Clinical Programs and Business Update:
MCLA-128 (HER3 x HER2 Biclonics®): Phase 2 metastatic breast cancer cohort update planned for 2H 2019
The Phase 2 clinical trial evaluating MCLA-128 in combination treatments in two metastatic breast cancer (“MBC”) populations continues to enroll patients in the U.S. and
The single agent Phase 1/2 trial in solid tumors is ongoing in the non-small-cell lung cancer (“NSCLC”) and gastric cancer and gastroesophageal junction cancer (“GC/GEJ”) cohorts, with the GC/GEJ cohort enrollment completed. In the NSCLC cohort, an update is expected in the second half of 2019. In the gastric cancer patient population, as a next step Merus intends to explore collaboration options for potential trials in rational therapeutic combinations.
MCLA-128 is an antibody-dependent cell-mediated cytotoxicity (“ADCC”) -enhanced Biclonics® that inhibits the heregulin/HER3 tumor-signaling pathway in solid tumors. MCLA-128 is believed to work with HER2-targeted therapies and to overcome the resistance of tumor cells using two mechanisms: blocking growth and survival pathways to stop tumor expansion and recruitment and enhancement of immune effector cells to eliminate the tumor.
MCLA-117 (CLEC12A x CD3 Biclonics®): Initial data from Phase 1 trial expected 2H 2019
The Phase 1 clinical trial for MCLA-117 is progressing and preliminary anti-tumor activity has been observed. Dose escalation continues steadily and carefully in order to establish the optimal therapeutic window. Merus anticipates initial data for the Phase 1 trial in the second half of 2019 and plans to provide further guidance on the program upon announcement of the maximum tolerated dose.
MCLA-117 is a Biclonics® that binds with relative low affinity to CD3, a component of the T cell receptor present on all T cells, and relative high affinity to CLEC12A, a cell surface molecule present on acute myeloid leukemia (“AML”) tumor cells and AML stem cells. MCLA-117 has been shown in preclinical studies to recruit and activate T-cells to kill CLEC12A-expressing malignant cells which may prevent recurrence of the tumor, while sparing hematopoietic stem cells. MCLA-117 has a full-length IgG format with a silenced constant region, which Merus believes may contribute to safety and attractive dosing schedules for patients.
MCLA-158 (Lgr5 x EGFR Biclonics®): Emerging data from Phase 1 trial expected at end of 2019
The dose escalation of the Phase 1 clinical trial of MCLA-158 in patients with solid tumors is ongoing. Emerging data for the Phase 1 trial is expected at the end of 2019.
MCLA-158 is an ADCC-enhanced Biclonics® that binds to cancer initiating cells expressing Lgr5 and EGFR. MCLA-158 has two different mechanisms of action. The first entails blocking of growth and survival pathways in cancer initiating cells. The second exploits the recruitment and enhancement of immune effector cells to directly kill cancer initiating cells that persist in solid tumors and can cause relapse and metastasis.
MCLA-145 (CD137 x PD-L1 Biclonics®): First patient treated in Phase 1 clinical trial
Merus is developing MCLA-145 as part of a collaboration entered into with
MCLA-145 is a Biclonics® T-cell agonist that has been observed to bind to human PD-L1 and CD137 in preclinical models. Discovered through an unbiased functional screening of multiple immunomodulatory target combinations, the differentiated profile of MCLA-145 derives from its potential to attract T cells into solid tumors, potently activate immune effector cells in the context of the tumor microenvironment and simultaneously block inhibitory signals in the same immune cell population.
Expanding Merus platform technology and next generation capabilities
The Company continues to explore and identify potential novel target combinations and cutting edge technologies to advance its next generation of multi-specific antibodies. Adding to existing capabilities, Merus has developed its new proprietary Triclonics™ technology. Triclonics™ employ a common light chain for unforced, natural pairing with three distinct VH regions, and is capable of simultaneously binding three different targets or epitopes with the potential for generating new biology and modes of action.
Merus U.S. office opened
First Quarter 2019 Financial Results
Total revenue for the three months ended
Research and development costs for the three months ended
Management and administration costs for the three months ended
Other expenses for the three months ended
For the three months ended
Merus ended the first quarter of 2019 with cash, cash equivalents and investments of €195.3 million compared to €205.5 million at
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 the second quarter of 2021.
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 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 is currently 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
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 sufficiency of our cash, cash equivalents and investments, our rapid maturation of the Company, the design and execution of our clinical trials and technology, the content and timing of potential milestones described in this press release, the timing of updates, guidance, information, clinical trials, their enrollment, and data readouts for our product candidates, the design and treatment potential of our bispecific antibody candidates, our exploration of collaboration options for potential combination trials in rational therapeutic combinations with MCLA-128 for gastric cancer, the potential contributions of MCLA-117’s full length IgG format with a silenced constant region to safety and an attractive dosing schedule, preclinical data for MCLA-158, which indicates its potential to be a leading targeted CRC treatment to block growth of tumors with RAS mutations and to block metastasis, the characteristics and immunostimulatory profile of MCLA-145, and this profile having a potential of MCLA-145 to overcome known side effects of CD137 agonists, the continuing collaboration with
These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 20-F filed with the
Unaudited Condensed Consolidated Statement of Financial Position
|March 31,||December 31,|
|(euros in thousands)|
|Property, plant and equipment, net||2,512||2,420|
|Lease right-of-use assets||2,596||-|
|Intangible assets, net||2,398||2,445|
|Taxes and social security assets||675||-|
|Trade and other receivables||8,282||7,032|
|Cash and cash equivalents||139,705||143,747|
|Issued and paid-in capital||2,104||2,102|
|Share premium account||264,877||264,854|
|Total shareholders’ equity||86,967||91,871|
|Deferred revenue, net of current portion||93,853||97,675|
|Taxes and social security liabilities||69||256|
|Other liabilities and accruals||8,787||7,964|
|Total shareholders’equity and liabilities||212,403||218,519|
Unaudited Condensed Consolidated Statement of Profit or Loss and Comprehensive Loss
|(euros in thousands, except per share data)|
|Research and development costs||(10,371||)||(10,298||)|
|Management and administration costs||(1,936||)||(2,852||)|
|Total operating expenses||(16,311||)||(15,836||)|
|Other income (expense)||2,471||(2,466||)|
|Result before taxation||(6,138||)||(8,381||)|
|Income tax expense||(66||)||(52||)|
|Result after taxation||(6,204||)||(8,433||)|
|Other comprehensive income|
|Exchange differences from the translation of foreign operations||23||(15||)|
|Total other comprehensive income for the period||23||(15||)|
|Total comprehensive loss for the period||(6,181||)||(8,448||)|
|Loss per share - basic and diluted*||(0.26||)||(0.40||)|
|Weighted average shares outstanding - basic and diluted*||23,373,054||20,984,663|
|*||For the periods included in these financial statements, share options were excluded from the diluted loss per share calculation as the Company was in a loss position in each period presented above. As a result, basic and diluted loss per share are equal.|
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Source: Merus N.V.