The oncology drug development landscape is competitive and requires innovation and clinical validation. In this space, companies leveraging novel platform technologies to create differentiated therapies stand out. With its focus on Biclonics and Multiclonics bispecific and multispecific antibodies, Merus (I have a strong inclination towards high-growth companies, often treading in sectors poised for exponential expansion. My expertise lies in understanding and investing in disruptive technologies and forwar ...

CONTACT: 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. IR/Corp Comms 617-230-4165 k.farren@merus.nl About Merus Merus is an oncology company developing innovative full-length human bispecific and trispecific antibody therapeutics, referred to as Multiclonics. Multiclonics are manufactured using industry standard processes and have been observed in preclinical and clinical studies to have seve ...

Core Viewpoint - Merus N.V. reported a quarterly loss of $0.41 per share, significantly better than the Zacks Consensus Estimate of a loss of $0.95, marking an earnings surprise of 56.84% [1] - The company generated revenues of $9.14 million for the quarter, missing the Zacks Consensus Estimate by 22.35%, but showing a year-over-year increase from $8.94 million [2] Financial Performance - The company has surpassed consensus EPS estimates two times over the last four quarters [2] - Merus shares have increased by approximately 8.3% since the beginning of the year, outperforming the S&P 500's gain of 1.3% [3] Future Outlook - The earnings outlook for Merus is uncertain, with current consensus EPS estimates of -$1.08 on revenues of $8.04 million for the upcoming quarter and -$4.18 on revenues of $54.05 million for the current fiscal year [7] - The estimate revisions trend for Merus is currently unfavorable, resulting in a Zacks Rank 4 (Sell), indicating expected underperformance in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Merus belongs, is currently ranked in the top 28% of over 250 Zacks industries, suggesting a favorable industry outlook [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Merus's stock performance [5]

Core Insights - Merus N.V. reported financial results for Q4 and the full year, highlighting its focus on innovative oncology treatments, particularly petosemtamab [1][22] - The company received two Breakthrough Therapy designations from the FDA for petosemtamab, indicating its potential to significantly improve treatment outcomes for certain cancers [2][9] Financial Performance - Collaboration revenue for 2024 decreased by $7.8 million compared to 2023, primarily due to declines in revenue from Lilly and Incyte, offset by increases from Gilead [22][24] - Research and development expenses increased by $84.7 million in 2024, mainly due to higher external clinical services and drug manufacturing costs [24] - General and administrative expenses rose by $23.0 million, driven by increased personnel costs and consultancy expenses [25] Clinical Development - Petosemtamab is undergoing multiple clinical trials, including phase 3 trials for r/m HNSCC and mCRC, with substantial enrollment expected by the end of 2025 [3][7] - Interim clinical data showed a 67% response rate for petosemtamab in combination with pembrolizumab in r/m HNSCC [5] - The company plans to provide updated clinical data for petosemtamab in the first half of 2025 [2][10] Cash Position - As of December 31, 2024, Merus had $724.0 million in cash, cash equivalents, and marketable securities, expected to fund operations into 2028 [21] Collaborations - Merus has established collaborations with several companies, including Incyte, Eli Lilly, Gilead, and Biohaven, focusing on the development of bispecific antibodies and novel therapies [16][17][20]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) c ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-37773 MERUS N.V. (Exact name of Registrant as specified in its Charter) The Netherlands Not Applicable (State or other jurisdiction ...

Core Insights - The U.S. FDA has granted Breakthrough Therapy designation (BTD) to petosemtamab in combination with pembrolizumab for first-line treatment of adult patients with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma (HNSCC) with CPS ≥ 1 [1][4] - This is the second BTD designation for petosemtamab, following the initial BTD and Fast Track designations for patients whose disease progressed after platinum-based chemotherapy and anti-PD-1 therapy [2] Clinical Data and Trials - The BTD is supported by updated data from an ongoing phase 1/2 trial showing a 67% response rate among 24 evaluable patients with PD-L1 positive r/m HNSCC [3] - Merus plans to conduct two phase 3 trials: LiGeR-HN1 will evaluate petosemtamab with pembrolizumab versus pembrolizumab alone, while LiGeR-HN2 will compare petosemtamab to standard therapies in patients who have progressed after anti-PD-1 and platinum therapies [5][6] Company Commitment and Future Plans - The company believes that the second BTD validates petosemtamab's potential to become a new standard of care for r/m HNSCC and emphasizes its commitment to accelerate development [4] - With the BTD, Merus aims to engage in expedited discussions with the FDA towards a potential Biologics License Application (BLA) submission [4] Background on HNSCC - HNSCC is a significant global health issue, with over 930,000 new cases and 465,000 deaths reported in 2020, and the incidence is expected to rise by 30% by 2030 [7][8] - The disease is associated with risk factors such as tobacco use, alcohol consumption, and HPV infections [7] About Petosemtamab - Petosemtamab is a Biclonics low-fucose human IgG1 antibody targeting EGFR and LGR5, designed to inhibit EGFR signaling and enhance immune-mediated cytotoxicity [9] About Merus N.V. - Merus is a clinical-stage oncology company focused on developing innovative bispecific and trispecific antibody therapeutics, known as Multiclonics, which have shown promising features in preclinical and clinical studies [10]

Core Viewpoint - Merus N.V. is a clinical-stage oncology company focused on developing innovative multispecific antibodies, with a presentation scheduled at Citi's 2025 Virtual Oncology Leadership Summit [1]. Company Overview - Merus N.V. specializes in full-length human bispecific and trispecific antibody therapeutics, known as Multiclonics® [3]. - The company utilizes industry-standard processes for manufacturing Multiclonics®, which have demonstrated characteristics similar to conventional human monoclonal antibodies, including long half-life and low immunogenicity in preclinical and clinical studies [3]. Event Details - Bill Lundberg, M.D., President and CEO of Merus, will present at the summit on February 20, 2025, at 9:00 a.m. ET [1]. - The presentation will be available via webcast on the company's Investors page, with an archived version accessible for a limited time post-event [2].

Core Viewpoint - Merus N.V. is a clinical-stage oncology company focused on developing innovative multispecific antibodies, with a presentation scheduled at Citi's 2025 Virtual Oncology Leadership Summit [1]. Group 1: Company Overview - Merus N.V. specializes in full-length human bispecific and trispecific antibody therapeutics, known as Multiclonics® [3]. - The company utilizes industry-standard processes for manufacturing Multiclonics®, which exhibit characteristics similar to conventional human monoclonal antibodies, including long half-life and low immunogenicity [3]. Group 2: Event Details - Bill Lundberg, M.D., President and CEO of Merus, will present at the summit on February 20, 2025, at 9:00 a.m. ET [1]. - The presentation will be available via webcast on the company's Investors page, with an archived version accessible for a limited time post-event [2].

Core Insights - Merus N.V. announced the publication of results from the eNRGy trial for Bizengri (zenocutuzumab), the first treatment for adults with advanced unresectable or metastatic pancreatic adenocarcinoma or non-small cell lung cancer (NSCLC) harboring NRG1 gene fusion [1][2][3] Company Overview - Merus is a clinical-stage oncology company focused on developing innovative full-length multispecific antibodies, known as Biclonics and Triclonics [1][29] - The company has made significant progress in its clinical pipeline, emphasizing the importance of its proprietary Biclonics antibody technologies [2] Clinical Trial Results - The eNRGy trial included 204 patients across 12 tumor types, demonstrating durable efficacy of Bizengri in advanced NRG1+ cancers, particularly in NSCLC and pancreatic adenocarcinoma, with a favorable safety profile [3][21] - The trial's main outcome measures were overall response rate (ORR) and duration of response (DOR), assessed by independent central review [21] Treatment Indications - Bizengri is indicated for adults with advanced unresectable or metastatic pancreatic adenocarcinoma or NSCLC with NRG1 gene fusion who have disease progression after prior systemic therapy [5][20] - The treatment received accelerated approval based on ORR and DOR, with continued approval contingent upon further verification of clinical benefit [5] Licensing Agreement - In December, Merus entered into an exclusive licensing agreement with Partner Therapeutics, Inc. for the commercialization of zenocutuzumab in the U.S. [4] Safety and Efficacy - The publication highlights the safety and efficacy of Bizengri, with serious adverse reactions reported in 23% of patients with NRG1+ pancreatic adenocarcinoma and 25% in NRG1+ NSCLC [15][17] - Common adverse reactions included increased alanine aminotransferase (51%), diarrhea (36%), and fatigue (21%) among pancreatic adenocarcinoma patients [16] Mechanism of Action - Bizengri is a bispecific antibody that inhibits HER2:HER3 dimerization and prevents NRG1 binding to HER3, leading to decreased cell proliferation and signaling through the PI3K-AKT-mTOR pathway [20] Patient Demographics - In the NRG1+ pancreatic adenocarcinoma group, the median age was 49 years, with 43% female and 87% White [22] - In the NRG1+ NSCLC group, the median age was 64 years, with 64% female and 56% Asian [23]

Collaboration Overview - Biohaven Ltd and Merus N V announced a research collaboration and license agreement to co-develop three novel bispecific antibody drug conjugates (ADCs) leveraging Merus' Biclonics technology platform and Biohaven's next-generation ADC conjugation and payload platform technologies [1] - The collaboration aims to rapidly advance bispecific antibody candidate ADCs based on the Merus Biclonics platform, combining Merus' validated Biclonics technology with Biohaven's innovative ADC technologies [4][6] Agreement Terms - Biohaven is responsible for the preclinical ADC generation of three Merus bispecific antibodies under mutually agreed research plans [3] - The agreement includes two Merus bispecific programs generated using the Biclonics platform and one program under preclinical research by Merus [3] - Merus will receive an upfront payment and license fee at ADC candidate nomination of the first program, with Merus assuming the preclinical bispecific antibody generation cost and Biohaven assuming the preclinical ADC generation cost [5] - Upon mutual agreement to advance each program, the parties plan to share further development and commercialization costs [5] Technology and Expertise - Merus' Biclonics technology has been validated by the recent FDA approval of Bizengri and continued clinical success with petosemtamab [4][6] - Biohaven brings expertise in ADC research and development, along with a broad range of linker/payload and conjugation technologies [4][6] - The collaboration aims to generate new and differentiated bispecific therapies with greater potency and selectivity over currently available monoclonal ADC approaches [4][6] Company Background - Merus is a clinical-stage oncology company developing innovative full-length human bispecific and trispecific antibody therapeutics, referred to as Multiclonics [9] - Biohaven is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology [10] Contact Information - Merus Investor and Media Inquiries: Sherri Spear, SVP Investor Relations and Strategic Communications, 617-821-3246, s spear@merus nl; Kathleen Farren, Assoc Director IR/Corp Comms, 617-230-4165, k farren@merus nl [12] - Biohaven Investor and Media Inquiries: Jennifer Porcelli, Vice President, Investor Relations, jennifer porcelli@biohavenpharma com, +1 (201) 248-0741; Mike Beyer, Sam Brown Inc, mikebeyer@sambrown com, +1 (312) 961-2502 [12]