Merus Reports Q3 2024 Financial Results and Business Update

Merus N.V., a clinical-stage oncology company specializing in the development of innovative multispecific antibodies, released its financial results for the third quarter and provided a comprehensive business update.

The company highlighted significant progress in its phase 3 registrational trials, particularly focusing on petosemtamab. These trials involve evaluating petosemtamab in combination with pembrolizumab for first-line treatment and as a monotherapy for second/third-line recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). Merus has announced that these studies are actively enrolling patients, marking a critical step forward in cancer treatment without chemotherapy.

Dr. Bill Lundberg, President and CEO, expressed optimism about the operational strides and the potential of petosemtamab as a pioneering chemo-free treatment for HNSCC patients. He emphasized the anticipation of presenting detailed data on the efficacy, duration, and safety of petosemtamab monotherapy at the upcoming ESMO® Asia Congress in December.

Petosemtamab, categorized under the designation MCLA-158, is being investigated across multiple trials. The LiGeR-HN1 phase 3 trial, which targets first-line HNSCC in combination with pembrolizumab, and the LiGeR-HN2 phase 3 trial, focusing on second/third-line HNSCC as a monotherapy, are actively enrolling participants. Additionally, a phase 2 trial is underway for second-line metastatic colorectal cancer (mCRC).

In the third quarter, Merus dosed its first patient in the LiGeR-HN1 trial. This trial evaluates the combination of petosemtamab and pembrolizumab against pembrolizumab alone in first-line HNSCC patients with PD-L1 expression. Notably, interim results from the American Society of Clinical Oncology® (ASCO) Annual Meeting demonstrated a 67% response rate among evaluable patients, showcasing the potential efficacy of this combination therapy.

Further insights came from the American Association of Cancer Research® (AACR®) Annual Meeting, where Merus reported a 37% response rate in patients receiving petosemtamab monotherapy for second-line HNSCC. The company plans to present updated efficacy and safety data at ESMO® Asia in December, reflecting ongoing efforts to fine-tune dosing strategies.

Merus also initiated a phase 2 trial evaluating petosemtamab with standard chemotherapy for second-line mCRC. This trial signifies the expanding scope of petosemtamab's application in solid tumor treatments.

Another highlight involves Zenocutuzumab (Zeno), a bispecific antibody for treating NRG1 fusion-positive cancers. The U.S. FDA has accepted a Biologics License Application (BLA) for Zeno, granting it priority review status. This development underscores Merus' commitment to advancing treatment options for patients with non-small cell lung cancer (NSCLC) and pancreatic cancer (PDAC).

MCLA-129, another candidate targeting EGFR and c-MET, is under investigation for METex14 NSCLC. The phase 2 trial involves cohorts receiving MCLA-129 with various chemotherapy agents. Merus maintains a collaboration with Betta Pharmaceuticals for developing and potentially commercializing MCLA-129 in China, while retaining global rights outside China.

The company's phase 1 trial of MCLA-145 in combination with pembrolizumab continues, demonstrating ongoing exploration of novel therapeutic combinations.

Merus' strategic collaborations play a crucial role in its research and development efforts. Partnerships with Incyte Corporation, Eli Lilly and Company, Gilead Sciences, and Ono Pharmaceutical enable the advancement of bispecific antibody technologies, potentially leading to significant milestones and future revenue streams.

Financially, Merus reported a robust cash position, with $782.9 million in cash, cash equivalents, and marketable securities as of September 30, 2024. The company anticipates that its current financial resources will support operations into 2028, reflecting a strong runway for continued innovation and development.

In summary, Merus N.V. is making significant strides in developing novel antibody therapies for cancer treatment, supported by robust clinical trials, strategic collaborations, and a solid financial foundation. The upcoming data presentations and ongoing trials underscore Merus' commitment to advancing oncology therapeutics and potentially transforming cancer care.