UTRECHT, The Netherlands and CAMBRIDGE, Mass. — August 5, 2025 — Leads & Copy —
Merus N.V. (Nasdaq: MRUS) announced its second-quarter financial results and provided a business update. The company’s existing cash, cash equivalents, and marketable securities are expected to fund operations at least into 2028, including $345 million gross proceeds from a public offering.
According to Bill Lundberg, M.D., President and CEO of Merus, the company shared the efficacy of petosemtamab with pembrolizumab in first-line head and neck cancer at ASCO 2025. The response from clinicians and KOLs, continues to drive phase 3 site activation. The data enhances the likelihood of clinical success of petosemtamab and initial clinical data on mCRC is expected in the second half of 2025.
Key updates on product candidates:
Petosemtamab (MCLA-158: EGFR x LGR5 Biclonics®): Solid Tumors:
LiGeR-HN1 phase 3 trial in 1L recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC) and LiGeR-HN2 phase 3 trial in 2/3L r/m HNSCC enrolling – with both trials expected to be substantially enrolled by YE25 and potential top line interim readout for one or both trials in 2026; phase 2 trial in 1L, 2L and 3L+ metastatic colorectal cancer (mCRC) enrolling; mCRC initial clinical data planned for 2H25
Merus provided updated interim clinical data from the phase 2 trial of petosemtamab with pembrolizumab as 1L treatment for PD-L1+ (CPS≥1) r/m HNSCC at the 2025 American Society of Clinical Oncology® (ASCO®) Annual Meeting, demonstrating a 63% response rate among 43 evaluable patients and a 79% overall survival rate at 12 months.
LiGeR-HN1, a phase 3 trial evaluating the efficacy and safety of petosemtamab in combination with pembrolizumab in 1L PD-L1+ r/m HNSCC compared to pembrolizumab, and LiGeR-HN2, a phase 3 trial evaluating the efficacy and safety of petosemtamab in 2/3L HNSCC compared to standard of care, are enrolling and the trials are expected to be substantially enrolled by YE25.
In February 2025, the FDA granted Breakthrough Therapy designation (BTD) to petosemtamab with pembrolizumab for first-line treatment of adult patients with recurrent or metastatic programmed death-ligand 1 (PD-L1) positive HNSCC with combined positive score (CPS) ≥ 1. BTD was also granted for petosemtamab monotherapy for patients with recurrent or metastatic HNSCC whose disease has progressed following treatment with platinum based chemotherapy and an anti-programmed cell death receptor-1 (PD-1) or anti-programmed death ligand 1 (PD-L1) antibody.
Merus provided updated interim clinical data on petosemtamab monotherapy in 2L+ r/m HNSCC at the European Society for Medical Oncology Asia Congress, demonstrating a 36% response rate among 75 evaluable patients.
A phase 2 trial evaluating petosemtamab with standard chemotherapy in 1L and 2L mCRC, and as monotherapy in heavily pretreated (3L+) mCRC, is enrolling. Initial clinical data for petosemtamab in mCRC is expected in 2H25.
BIZENGRI® (zenocutuzumab-zbco: HER2 x HER3 Biclonics®):
Approved by FDA for adults with pancreatic adenocarcinoma or non–small cell lung cancer (NSCLC) that are advanced unresectable or metastatic and harbor a neuregulin 1 (NRG1) gene fusion who have disease progression on or after prior systemic therapy.
Merus has licensed to Partner Therapeutics, Inc. (PTx) the right to commercialize BIZENGRI® for the treatment of NRG1+ cancer in the U.S.
MCLA-129 (EGFR x c-MET Biclonics®): Solid Tumors
Investigation of MCLA-129 is ongoing in METex14 NSCLC; phase 2 trial in combination with chemotherapy in 2L+ EGFR mutant (EGFRm) NSCLC enrolling.
MCLA-129 is subject to a collaboration and license agreement with Betta Pharmaceuticals Co. Ltd. (Betta), which permits Betta to develop MCLA-129, and potentially commercialize exclusively in China, while Merus retains global rights outside of China.
Incyte Corporation:
Since 2017, Merus has been working with Incyte Corporation (Incyte) under a global collaboration and license agreement focused on the research, discovery and development of bispecific antibodies. During the second quarter of 2025, Merus received the milestone payment of $1 million for the candidate nomination of a discovery program.
Eli Lilly and Company:
In January 2021, Merus and Eli Lilly and Company (Lilly) announced a research collaboration and exclusive license agreement to develop up to three CD3-engaging T-cell re-directing bispecific antibody therapies. The collaboration is progressing well with two programs advancing through preclinical development.
Gilead Sciences:
In March 2024, Merus and Gilead Sciences announced a collaboration to discover novel antibody based trispecific T-cell engagers using Merus’ patented Triclonics® platform. The collaboration is progressing well with two programs advancing through preclinical development.
Ono Pharmaceutical:
In 2018, the Company granted Ono Pharmaceutical Co., Ltd. (Ono) an exclusive, worldwide, royalty-bearing license to research, test, make, use and market a limited number of bispecific antibody candidates.
Biohaven:
In January 2025, Merus and Biohaven announced a research collaboration and license agreement to co-develop three novel bispecific antibody drug conjugates (ADCs). Under the terms of the agreement, Biohaven is responsible for the preclinical ADC generation of three Merus bispecific antibodies under mutually agreed research plans.
Corporate Activities:
Completed public offering raising $345M gross proceeds.
As of June 30, 2025, Merus had $892 million cash, cash equivalents and marketable securities. Based on the Company’s current operating plan, the existing cash, cash equivalents and marketable securities are expected to fund Merus’ operations at least into 2028.
Second Quarter 2025 Financial Results:
Total revenue for the three months ended June 30, 2025 increased by $1.5 million as compared to the three months ended June 30, 2024, primarily as a result of increases in Incyte revenue of $1.5 million, PTx revenue of $0.5 million, and Gilead revenue of $0.1 million, partially offset by a decrease in Lilly revenue of $0.6 million.
Research and development (R&D) expense for the three months ended June 30, 2025 increased by $44.8 million as compared to the three months ended June 30, 2024.
General and administrative expense for the three months ended June 30, 2025 increased by $2.7 million as compared to the three months ended June 30, 2024.
Total revenue for the six months ended June 30, 2025 increased by $20.1 million as compared to the six months ended June 30, 2024.
Research and development expense for the six months ended June 30, 2025 increased by $86.3 million as compared to the six months ended June 30, 2024.
General and administrative expense for the six months ended June 30, 2025 increased by $8.7 million as compared to the six months ended June 30, 2024.
Investor and Media Inquiries: Sherri Spear Merus N.V. SVP Investor Relations and Strategic Communications 617-821-3246 s.spear@merus.nl Kathleen Farren Merus N.V. Director Investor Relations and Corporate Communications 617-230-4165 k.farren@merus.nl
Source: Merus N.V.
