Merus (MRUS) FY 2025 Conference September 04, 2025 03:45 PM ET Company ParticipantsBill Lundberg - CEO, President & Executive DirectorConference Call ParticipantsBenjamin Burnett - AnalystBenjamin BurnettThank you guys for joining us for our next Fireside Chat. I'm happy to be here with Merus N.V., Dr. Sven Lundberg. My name is Ben Burnett, biotech analyst here at Wells Fargo, filling in for Eva Portillo-Verdejo. Thank you for being here.Bill LundbergGreat, thank you, Ben. Great to reconnect with you. We mi ...

Merus (MRUS) FY 2025 Conference September 04, 2025 03:45 PM ET Speaker0Thank you guys for joining us for our next Fireside Chat. I'm happy to be here with Merus N.V., Dr. Sven Lundberg. My name is Ben Burnett, biotech analyst here at Wells Fargo, filling in for Eva Portillo-Verdejo. Thank you for being here.Speaker1Great, thank you, Ben. Great to reconnect with you. We miss Eva today, but excited for her and her family, and really appreciate the relationship we are developing with Wells Fargo.Speaker0Great. ...

Core Insights - Merus N.V. announced promising clinical trial results for petosemtamab in combination with pembrolizumab, showing a 63% response rate among 43 evaluable patients and a 79% overall survival rate at 12 months in a phase 2 trial for PD-L1+ recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) [1][3][6] Clinical Trials and Efficacy - The ongoing LiGeR-HN1 and LiGeR-HN2 phase 3 trials are expected to be substantially enrolled by the end of 2025, with potential interim readouts in 2026 [4][5] - Initial clinical data for petosemtamab in metastatic colorectal cancer (mCRC) is anticipated in the second half of 2025 [2][8] Financial Overview - The company completed a public offering raising $345 million in gross proceeds, which, along with existing cash and marketable securities, is expected to fund operations at least into 2028 [17][18] - Total revenue for Q2 2025 increased by $1.5 million compared to Q2 2024, driven by collaboration revenues [19] - Research and development expenses for Q2 2025 rose by $44.8 million, primarily due to increased clinical trial support related to petosemtamab [20] Collaborations and Licensing - Merus has established collaborations with several companies, including Incyte, Eli Lilly, Gilead Sciences, and Biohaven, focusing on the development of bispecific antibodies and novel therapies [11][12][15][16] - The company has licensed BIZENGRI for commercialization in the U.S. for specific cancer types, enhancing its market presence [9] Cash Position and Runway - As of June 30, 2025, Merus reported $892 million in cash, cash equivalents, and marketable securities, providing a strong financial position to support ongoing and future clinical trials [18]

Core Insights - Merus N.V. announced the publication of the mechanism of action for petosemtamab, a bispecific antibody targeting EGFR and LGR5, in the journal "Cancers" [1][2] Company Overview - Merus is focused on developing innovative full-length human bispecific and trispecific antibody therapeutics, known as Multiclonics, which exhibit features similar to conventional human monoclonal antibodies [5] - Petosemtamab, also known as MCLA-158, is a low-fucose human full-length IgG1 antibody designed to target EGFR and LGR5, employing three independent mechanisms of action [6] Clinical Development - Petosemtamab has shown substantial clinical activity in recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC), with ongoing Phase 3 trials in both first-line and second/third-line settings [3][4] - A Phase 2 trial is currently evaluating petosemtamab in combination with standard chemotherapy for metastatic colon cancer (mCRC), with initial clinical data expected in the second half of 2025 [4] Mechanism of Action - Petosemtamab operates through three distinct mechanisms: blocking EGFR ligands, internalizing and degrading EGFR in LGR5+ cells, and activating the innate immune system via antibody-dependent cellular phagocytosis (ADCP) and enhanced antibody-dependent cellular cytotoxicity (ADCC) [2][6] Market Context - Head and neck squamous cell carcinoma (HNSCC) is the sixth most common cancer globally, with over 930,000 new cases and more than 465,000 deaths reported in 2020, and the incidence is expected to rise by 30% by 2030 [7]

Group 1: Clinical Trials and Updates - The ongoing phase 2 trial of petosemtamab in combination with pembrolizumab for first-line treatment of PD-L1+ recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) is set to present updated interim data at the 2025 ASCO Annual Meeting [1][3] - Merus is conducting two phase 3 trials (LiGeR-HN1 and LiGeR-HN2) for petosemtamab in HNSCC, with expectations for substantial enrollment by the end of 2025 [2][6] - An updated analysis of interim clinical data from the phase 2 trial will include results from a total of 45 patients, showcasing the drug's efficacy and safety [3][4] Group 2: Financial Performance - As of March 31, 2025, Merus reported $638 million in cash, cash equivalents, and marketable securities, which are expected to fund operations into 2028 [17] - Collaboration revenue for Q1 2025 increased by $18.6 million compared to Q1 2024, driven by commercial material revenue and higher deferred revenue amortization [18] - Research and development expenses rose by $41.5 million in Q1 2025 compared to the same period in 2024, primarily due to increased clinical trial support related to petosemtamab [19] Group 3: Regulatory Designations - The U.S. FDA granted Breakthrough Therapy designation to petosemtamab in combination with pembrolizumab for first-line treatment of adult patients with PD-L1 positive HNSCC [4] - A similar designation was granted for petosemtamab monotherapy for patients with recurrent or metastatic HNSCC who have progressed after prior treatments [4] Group 4: Collaborations and Partnerships - Merus has established collaborations with several companies, including Incyte, Eli Lilly, Gilead Sciences, and Biohaven, focusing on the development of bispecific antibodies and novel therapies [11][12][16] - The collaboration with Partner Therapeutics for the commercialization of BIZENGRI in the U.S. for NRG1+ cancer has been highlighted [9] Group 5: Product Pipeline - The company is also enrolling patients in a phase 2 trial for petosemtamab in metastatic colorectal cancer (mCRC), with initial clinical data expected in the second half of 2025 [8] - MCLA-129, another product under investigation, is in a phase 2 trial for EGFR mutant non-small cell lung cancer (NSCLC) [10]