Merus Announces Financial Results for the Third Quarter 2019 and Provides 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
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
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
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
MCLA-129 (EGFR x c-MET Biclonics®): Pre-clinical data presented at medical conference October 2019
Third 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 third quarter of 2019 with cash, cash equivalents and investments of €168.1 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 2022. The Company’s outlook has been updated given the recent equity financing in
Unaudited Condensed Consolidated Statement of Financial Position
|(euros in thousands)|
|Property, plant and equipment, net||3,422||2,420|
|Lease right-of-use assets||5,843||-|
|Intangible assets, net||2,304||2,445|
|Trade and other receivables||9,218||7,032|
|Cash and cash equivalents||123,480||143,747|
|Common share capital||2,107||2,102|
|Common share premium||264,892||264,854|
|Total shareholders’ equity||70,375||91,871|
|Deferred revenue, net of current portion||85,361||97,675|
|Taxes and social security liabilities||183||256|
|Other liabilities and accruals||9,866||7,964|
|Total shareholders’ equity and liabilities||189,863||218,519|
Unaudited Condensed Consolidated Statement of Operations
|Three months ended||Nine months ended|
|September 30,||September 30,|
|(euros in thousands, except per share data)|
|Research and development costs||(12,814||)||(11,896||)||(33,169||)||(34,717||)|
|Management and administration costs||(2,852||)||(2,658||)||(7,907||)||(8,149||)|
|Total operating expenses||(20,026||)||(18,503||)||(53,183||)||(52,798||)|
|Other income (expense)||3,586||1,366||5,389||6,310|
|Result before taxation||(8,325||)||(10,623||)||(26,398||)||(23,510||)|
|Income tax expense||1||(67||)||(119||)||(206||)|
|Result after taxation||(8,324||)||(10,690||)||(26,517||)||(23,716||)|
|Other comprehensive income|
|Exchange differences from the translation of foreign operations||64||5||70||26|
|Total other comprehensive income for the period||64||5||70||26|
|Total comprehensive loss for the period||(8,260||)||(10,685||)||(26,447||)||(23,690||)|
|Loss per share - basic and diluted *||(0.35||)||(0.47||)||(1.13||)||(1.07||)|
|Weighted average shares outstanding - basic and diluted *||23,402,887||22,687,034||23,388,036||22,105,524|
*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.
Merus is a clinical-stage immuno-oncology company developing innovative full-length human bispecific antibody therapeutics, referred to as Biclonics®. Biclonics® 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, please visit Merus’ website, www.merus.nl and https://twitter.com/MerusNV.
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 belief regarding the early clinical data and its impact on the clinical validation of our Biclonics® platform, our plans to identify and recruit patients who may be amenable to MCLA-128 therapy and to execute on all of our pipeline programs, our clinical development plans for MCLA-128 including plans to only advance development in metastatic breast cancer or gastric cancer with a collaborator, the intent to focus MCLA-128 program efforts on the eNRGy trial going forward, the timing of clinical trial results, the sufficiency of our cash, cash equivalents and investments, the design, execution and progress of our clinical trials and technology, the content and timing of potential milestones described in this press release, the timing of updates, guidance and information of clinical trials, their future enrollment, and data readouts for our product candidates, including future availability of more mature data, better characterization of the patient population and activity of MCLA-128 in a larger set of patients, the design and treatment potential of our bispecific antibody candidates, the amendment and continued dose escalation of MCLA-117, its impact on Merus’ plans to explore higher dosing and to present initial data at a medical conference in the first half of 2020, the dose escalation of the Phase 1 clinical trial of MCLA-158 and its progress as planned, Merus’ plan to report at the end of 2019 emerging data for the Phase 1 trial, including safety and information around the recommended Phase 2 dose, Merus’ plans to provide further guidance on the program in 2020, 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 currently in development, 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
Biclonics® is a registered trademark of
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Source: Merus N.V.