MERUS ANNOUNCES SECOND QUARTER 2017 FINANCIAL RESULTS AND HIGHLIGHTS RECENT PROGRESS
UTRECHT, The Netherlands, Sept. 19, 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 second quarter ended June 30, 2017 and provided a corporate and clinical update.
“Merus has had a productive year to date, marked by progress in our work with Incyte and our other collaborators, the presentation at ASCO of positive Phase 1/2 data for our lead candidate MCLA-128 in the first of several indications, and progress among a stable of very exciting Biclonics®-based bispecific antibody therapy candidates toward and through the clinic,” said Ton Logtenberg, Ph.D., Chief Executive Officer of Merus. “We believe that the potential of Merus’ Biclonics® platform, which holds a number of key advantages over other bispecific antibody approaches, has only just begun to reveal itself.”
“The balance of the year holds a number of key anticipated milestones, including initiating a Phase 2 trial of MCLA-128-based combinations in two metastatic breast cancer (MBC) populations, a decision on development of MCLA-128 in gastric, ovarian and endometrial cancers based on an expected data readout, progression of dose escalation in the Phase 1 trial evaluating MCLA-117 in acute myeloid leukemia (AML) under a Clinical Trial Authorization (CTA), filing of an Investigational New Drug (IND) submission for MCLA-117, and filing of a CTA for a first-in-human clinical trial of MCLA-158 in patients with colorectal cancer. We also look forward to initiating an IND-enabling study for MCLA-145, a bispecific antibody designed to bind to PD-L1 and to another undisclosed immunomodulatory target, a program that is part of our collaboration with Incyte,” added Dr. Logtenberg.
Recent Clinical & Corporate Developments
In Part 2 of the Phase 1/2 MCLA-128 study in solid tumors, treatment was completed for a cohort of heavily pre-treated HER2+ MBC patients (n=11) using MCLA-128 as a single agent which resulted in an overall clinical benefit rate (defined as complete response plus partial response plus stable disease lasting at least 12 weeks) of 64%. With single agent activity established in MBC, the initiation of a Phase 2 clinical trial is anticipated in the fourth quarter of 2017 described further below under “Anticipated 2017 Milestones”.
Merus and Incyte Corporation (NASDAQ:INCY) have advanced the first candidate from their global strategic research collaboration into an IND-enabling study. MCLA-145 is designed to bind to PD-L1 and to a second undisclosed immunomodulatory target to treat various solid tumors. 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.
Merus received a favorable ruling from the U.S. Court of Appeals for the Federal Circuit which affirmed that Regeneron Pharmaceuticals engaged in inequitable conduct during the patent prosecution of U.S. Patent No. 8,502,018, resulting in the patent’s unenforceability.
Anticipated 2017 Milestones
During the fourth quarter, Merus expects to initiate a Phase 2, open label, multi-center international clinical trial to evaluate MCLA-128-based combinations in two MBC populations: (1) confirmed HER2-positive MBC patients (progressing on 2 to 4 anti-HER2 therapies, including TDM-1) who will receive MCLA-128 in combination with trastuzumab with and without chemotherapy, and (2) confirmed ER+/HER2-low MBC patients progressing on one or more prior endocrine therapies and CDK4/6 inhibitors who will receive MCLA-128 in combination with endocrine therapy. The trial is expected to enroll approximately 120 patients in total with approximately 60 patients targeted in each cohort.
Merus is continuing its dose escalation of the Phase I clinical trial for MCLA-117 in Europe and expects to submit an IND application to the U.S. Food and Drug Administration in the fourth quarter of 2017.
By the end of 2017, Merus expects to file a CTA for a first-in-human clinical trial of MCLA-158 in patients with colorectal cancer.
Second Quarter 2017 Financial Results
Merus ended the second quarter of 2017 with cash and cash equivalents of €215.8 million compared to €56.9 million at December 31, 2016.
Total revenue for the three months ended June 30, 2017 was €4.0 million compared to €1.1 million for the same period in 2016. Revenue is comprised primarily of 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 June 30, 2017 were €8.4 million compared to €3.8 million for the same period in 2016. The increase in research and development costs quarter over quarter, reflects higher enrollment in our clinical trials and expansion of pre-clinical research efforts to support our collaboration with Incyte.
For the three months ended June 30, 2017, Merus reported a net loss of €21.8 million, or a loss of €1.12 per basic and diluted share, compared to a net loss of €4.9 million, or a loss of €0.40 per basic and diluted share, for the same period in 2016. The net loss for the three months ended June 30, 2017 includes approximately €12.0 million of unrealized foreign currency losses and approximately €3.3 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.