Merus Reports Q2 2024 Financials and Business Update

Merus N.V., a clinical-stage oncology company, recently announced its financial results for the second quarter of 2024 and provided a business update. The company, which specializes in developing innovative multispecific antibodies, showcased significant progress across its clinical programs.

Petosemtamab (MCLA-158), a bispecific antibody targeting EGFR and LGR5, demonstrated promising results in combination with pembrolizumab at the 2024 ASCO Annual Meeting. Among 24 evaluable patients with head and neck squamous cell carcinoma (HNSCC), a 67% response rate was observed. This data supports the continued development of petosemtamab, with plans to initiate a phase 3 trial (LiGeR-HN1) by the end of 2024. Furthermore, an ongoing phase 3 trial (LiGeR-HN2) is evaluating petosemtamab monotherapy in 2/3L HNSCC, with the first patient already dosed.

Merus also announced that petosemtamab has been granted Breakthrough Therapy Designation (BTD) by the FDA for the treatment of recurrent or metastatic HNSCC. This designation is expected to expedite the development and review process, potentially supporting accelerated approval based on overall response rates.

In colorectal cancer (mCRC), a phase 2 trial is enrolling patients to evaluate the combination of petosemtamab with FOLFIRI. This trial aims to assess the safety and preliminary antitumor activity of the combination in second-line treatment.

Zenocutuzumab (MCLA-128), another bispecific antibody targeting HER2 and HER3, is under priority review by the FDA for the treatment of NRG1+ non-small cell lung cancer (NSCLC) and pancreatic cancer (PDAC). The company is actively seeking a commercialization partnership to bring Zenocutuzumab to patients if approved.

MCLA-129, targeting EGFR and c-MET, is being evaluated in NSCLC with METex14 skipping mutations. At the 2024 ASCO meeting, Merus presented data indicating promising single-agent efficacy. In addition, a phase 2 trial is underway to investigate MCLA-129 in combination with chemotherapy in EGFR mutant NSCLC.

The company is also advancing MCLA-145, a bispecific antibody targeting CD137 and PD-L1. Interim clinical data presented at the 2024 ASCO meeting showed encouraging results for both monotherapy and combination therapy with pembrolizumab in advanced solid tumors.

On the corporate front, Merus completed a public offering, raising $460 million in gross proceeds. This funding is expected to support the company's operations into 2028. As of June 30, 2024, Merus reported cash, cash equivalents, and marketable securities totaling $846.4 million.

Merus has also been active in strategic collaborations. The company continues to work with Incyte Corporation on bispecific antibody programs, receiving milestone payments for accomplishments in early 2024. A research collaboration with Eli Lilly and Company is progressing well, focusing on the development of CD3-engaging bispecific antibody therapies. Additionally, a collaboration with Gilead Sciences aims to discover trispecific T-cell engagers, with Merus receiving significant upfront payments and equity investments.

Financially, Merus reported decreased collaboration revenue for the three and six months ended June 30, 2024, compared to the same periods in 2023. However, the company saw increased research and development expenses due to higher costs associated with clinical services, drug manufacturing, and collaboration agreements. General and administrative expenses also rose, driven by increased personnel costs and consulting expenses.

In summary, Merus N.V. is making significant strides in its clinical programs, supported by robust financial health and strategic partnerships. The company's innovative approaches in oncology hold promise for addressing unmet medical needs, with several key trials and regulatory milestones on the horizon.

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