Merus Announces Financial Results for the Full Year 2018 and Provides Business Update
“2018 was an exciting year for Merus with several developments that have helped to advance our leadership position in bispecific antibodies,” said Ton Logtenberg, Ph.D., President, Chief Executive Officer and Principal Financial Officer of Merus. “We have continued to make significant progress in our clinical programs and further advances in our R&D platform. Looking ahead, 2019 will be an important year as we anticipate reaching several clinical milestones in our programs, including a trial initiation in MCLA-145, first clinical data for MCLA-117 and MCLA-158, and Phase 2 data for MCLA-128.”
Clinical Programs and Business Update:
MCLA-128: 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 and gastric cancer (“GC”) cohorts, with the GC cohort enrollment now complete. In
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: 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: 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.
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Importantly, preclinical data showed MCLA-158 activity in >60% of patient tumor organoids (15/24) regardless of RAS mutational status, which indicates that MCLA-158 has the potential to be the first targeted colorectal cancer (“CRC”) treatment to block growth of tumors with RAS mutations (present in ~50% of all CRC patients).
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: Expected to enter clinical trials 2Q 2019 in collaboration with
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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.
Collaborations in
Following the collaboration with
In preclinical studies, MCLA-129 showed a significant reduction in tumor volume for EGFR inhibitor resistant lung cancer models lacking immune cells. Additionally, in cell lines that co-express both EGFR and c-MET, MCLA-129 effectively induced tumor cell lysis at low antibody concentrations. Because its Dock & Block® and ADCC mechanism of action is based on the co-expression of EGFR and c-MET, it is expected to have less toxicity compared to agents targeting EGFR alone.
This latest deal is representative of the strategic collaborations Merus plans to continue to seek in order to leverage collaborators’ investment, particularly in Chemistry, Manufacturing and Controls (CMC) and IND-enabling studies, to advance more programs from Merus’ rich preclinical pipeline into the clinic.
MCLA-129 is a Biclonics® binding to EGFR and c-MET for the treatment of solid tumors. EGFR is an important oncogenic driver in many cancers. The upregulation of c-MET signaling has been associated with resistance to EGFR inhibition. MCLA-129 has two distinct mechanisms of action. First, Merus’ Dock & Block® mechanism of action blocks the signaling of EGFR as well as c-MET, with the potential to inhibit tumor growth and survival. Second, MCLA-129 utilizes GlymaxX® ADCC-enhancement technology designed for greater cell-killing potential.
2018 court rulings and global litigation settlement
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In
New U.S. headquarters planned for Q2 2019 opening
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Fourth Quarter 2018 Financial Results
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Full Year 2018 Financial Results
Merus ended 2018 with cash, cash equivalents and investments of €205.5 million compared to €190.8 million at
Total revenue for the year ended
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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 the second quarter of 2021.
About
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. For additional information on the company and programs, 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 sufficiency of our cash, cash equivalents and investments, our ability to produce differentiated, best-in-class bispecific antibody programs, the importance of 2019 for our company, including the content and timing of potential milestones described in this press release, the timing of updates, guidance, information, clinical trials and data readouts for our product candidates, the design and treatment potential of our bispecific antibody candidates, clinical study designs, our options and timing for potential combination trials for MCLA-128 in rational therapeutic combinations in the GC/GEJ cancer patient population, the potential contributions of MCLA-117’s full length IgG format with a silenced constant region to safety and predictability, preclinical data for MCLA-158, which indicates its potential to be the first targeted CRC treatment to block growth of tumors with RAS mutations, 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 potential for MCLA-145 to be first-in-class, our ability to use Betta’s regulatory filings and early stage clinical trial materials for potential ex-China development of MCLA-129, MCLA-129 toxicity compared to agents targeting EGFR alone, the potential of our current collaborations and our ability to engage in any future strategic collaborations to leverage collaborators’ investment, particularly in CMC and IND-enabling studies, to advance more programs from our rich preclinical pipeline into the clinic, and the opening of our U.S. headquarters and its value to our business and ability to secure a permanent footprint in
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 collaborations or our collaborators may fail to perform adequately under our collaborations; 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 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
| Unaudited Consolidated Statement of Financial Position | |||||
| December 31, | December 31, | ||||
| 2018 | 2017 Restated* | ||||
| (euros in thousands) | |||||
| Non-current assets | |||||
| Property, plant and equipment, net | 2,420 | 1,168 | |||
| Intangible assets, net | 2,445 | 312 | |||
| Non-current investments | 16,945 | 7,060 | |||
| Other assets | 1,075 | 129 | |||
| 22,885 | 8,669 | ||||
| Current assets | |||||
| Trade and other receivables | 7,032 | 4,413 | |||
| Current investments | 44,855 | 34,043 | |||
| Cash and cash equivalents | 143,747 | 149,678 | |||
| 195,634 | 188,134 | ||||
| Total assets | 218,519 | 196,803 | |||
| Shareholders’ equity | |||||
| Issued and paid-in capital | 2,102 | 1,749 | |||
| Share premium account | 264,854 | 213,618 | |||
| Accumulated loss | (175,085 | ) | (158,775 | ) | |
| Total shareholders’ equity | 91,871 | 56,592 | |||
| Non-current liabilities | |||||
| Deferred revenue, net of current portion | 97,675 | 112,551 | |||
| Current liabilities | |||||
| Trade payables | 3,819 | 2,855 | |||
| Taxes and social security liabilities | 256 | 243 | |||
| Deferred revenue | 16,934 | 15,935 | |||
| Other liabilities and accruals | 7,964 | 8,627 | |||
| 28,973 | 27,660 | ||||
| Total liabilities | 126,648 | 140,211 | |||
| Total shareholders’equity and liabilities | 218,519 | 196,803 | |||
| * | Accumulated loss and deferred revenue (current and non-current) have been restated for the impact of the retrospective effects 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 | Year ended | ||||||||||
| December 31, | December 31, | ||||||||||
| 2018 | 2017 Restated** | 2018 | 2017 Restated** | ||||||||
| (euros in thousands, except per share data) | |||||||||||
| Revenue | 8,470 | 6,070 | 31,448 | 21,915 | |||||||
| Research and development costs | (12,023 | ) | (11,050 | ) | (46,740 | ) | (34,125 | ) | |||
| Management and administration costs | (2,246 | ) | (2,265 | ) | (10,395 | ) | (13,697 | ) | |||
| Other expenses | (3,228 | ) | (2,807 | ) | (13,160 | ) | (9,395 | ) | |||
| Total operating expenses | (17,497 | ) | (16,122 | ) | (70,295 | ) | (57,217 | ) | |||
| Operating result | (9,027 | ) | (10,052 | ) | (38,847 | ) | (35,302 | ) | |||
| Finance income | 1,529 | 248 | 7,843 | 1,112 | |||||||
| Finance cost | - | (2,120 | ) | (4 | ) | (30,335 | ) | ||||
| Other income | 7,095 | - | 7,095 | - | |||||||
| Other income (expense) | 8,624 | (1,872 | ) | 14,934 | (29,223 | ) | |||||
| Result before taxation | (403 | ) | (11,924 | ) | (23,913 | ) | (64,525 | ) | |||
| Income tax expense | (150 | ) | (68 | ) | (356 | ) | (249 | ) | |||
| Result after taxation | (553 | ) | (11,992 | ) | (24,269 | ) | (64,774 | ) | |||
| Other comprehensive income | |||||||||||
| Exchange differences from the translation of foreign operations | 8 | 38 | 34 | 89 | |||||||
| Total other comprehensive income for the period | 8 | 38 | 34 | 89 | |||||||
| Total comprehensive loss for the period | (545 | ) | (11,954 | ) | (24,235 | ) | (64,685 | ) | |||
| Loss per share - basic and diluted* | (0.02 | ) | (0.62 | ) | (1.09 | ) | (3.37 | ) | |||
| Weighted average shares outstanding - basic and diluted* | 22,824,397 | 19,423,027 | 22,286,720 | 19,196,440 | |||||||
| * | 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. | |
| ** | Revenue for the three and twelve months ended December 31, 2017 has been restated to reflect additional revenue of €2.3 million, or €0.11 per share, and €8.3 million, or €0.43 per share, respectively, related to the amortization of the upfront license payment received from Incyte due to the impact of the retrospective effects of the adoption of IFRS 15, an accounting standard related to revenue recognition. |
Investor and Media Inquiries:Jillian Connell Merus N.V. Investor Relations and Corporate Communications 617-955-4716 j.connell@merus.nl
Source: Merus N.V.