Merus Reports Q1 2024 Financial Results and Business Update

Merus N.V., based in Utrecht, Netherlands, and Cambridge, Massachusetts, is a clinical-stage oncology company recognized for developing innovative full-length multispecific antibodies known as Biclonics® and Triclonics®. The company recently announced its financial results for the first quarter of 2024 and provided key business updates.

At the upcoming 2024 ASCO Annual Meeting, Merus plans to present initial interim clinical data on the safety and efficacy of petosemtamab, a bispecific antibody targeting EGFR and LGR5, in combination with pembrolizumab for the first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). This data could pave the way for a potential phase 3 trial. Additionally, Merus plans to initiate a phase 3 registration trial in mid-2024, comparing petosemtamab monotherapy to standard single-agent chemotherapy or cetuximab in previously treated HNSCC patients. 

Zenocutuzumab (Zeno), another promising therapeutic from Merus, has had its Biologics License Application (BLA) accepted for priority review by the U.S. Food and Drug Administration (FDA). This bispecific antibody targets HER2 and HER3 and is intended for patients with NRG1 fusion-positive non-small cell lung cancer (NSCLC) and pancreatic cancer (PDAC). If approved, Zeno would be the first targeted therapy available for patients with NRG1+ cancers. The company is also conducting translational work on potential biomarkers outside of NRG1+ cancers to explore further development opportunities for Zeno.

MCLA-129, an EGFR and c-MET targeting bispecific antibody, is currently being investigated in a phase 1/2 trial for NSCLC patients with c-MET exon 14 skipping mutations. Merus plans to expand this investigation to include combination therapy with chemotherapy in patients with EGFR mutant NSCLC in 2024.

Another candidate, MCLA-145, which targets CD137 and PD-L1, is being evaluated in a phase 1 trial as both monotherapy and in combination with pembrolizumab for solid tumors. Initial results from this trial are anticipated to be presented at ASCO 2024.

In the realm of research, Merus continues to showcase its technological advancements. At the 20th Annual PEGS Boston meeting, the company plans to present preclinical data demonstrating the compatibility and favorable pharmaceutical properties of its Biclonics® platform when conjugated with various linkers and payloads to create antibody-drug conjugates (ADClonics™). This platform holds potential for improved selectivity, internalization, and cancer cell killing activity.

Corporate developments at Merus are also notable. Effective May 7, 2024, Jason Haddock was appointed to the Board of Directors, bringing extensive experience from previous roles at companies such as Archer Dx, Array BioPharma, and Bristol-Myers Squibb.

Merus continues to foster significant collaborations to advance its research and development efforts. Its partnership with Incyte Corporation, established in 2017, focuses on the development of bispecific antibodies using Merus’ Biclonics® technology. This collaboration has recently achieved a milestone with the nomination of the fifth candidate, resulting in a $1 million payment expected in the second quarter of 2024.

Similarly, Merus’ collaboration with Eli Lilly and Company, initiated in 2021, aims to develop CD3-engaging T-cell redirecting bispecific antibody therapies. This partnership is progressing well with three ongoing programs in various stages of preclinical development.

In March 2024, Merus also entered a collaboration with Gilead Sciences to discover novel trispecific T-cell engagers using the Triclonics® platform. This agreement includes early-stage research activities led by Merus and an equity investment from Gilead amounting to $25 million, along with an upfront payment of $56 million.

Financially, Merus ended the first quarter of 2024 with $398.7 million in cash, cash equivalents, and marketable securities. The company expects these funds to support its operations into 2027. The first quarter saw a decrease in collaboration revenue to $7.9 million from $13.5 million in the previous year, primarily due to lower cost reimbursement revenue. Research and development expenses increased to $38.6 million, reflecting higher clinical and manufacturing costs, while general and administrative expenses rose slightly to $16.1 million. 

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