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]

PART I — FINANCIAL INFORMATION [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Merus N.V. as of March 31, 2025, and for the three-month periods ended March 31, 2025 and 2024 [Condensed Consolidated Financial Statements](index=6&type=section&id=Condensed%20Consolidated%20Financial%20Statements) The financial statements reveal a decrease in total assets to $730.9 million as of March 31, 2025, from $782.7 million at the end of 2024 Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $197,199 | $293,294 | | Total current assets | $522,272 | $569,072 | | Total assets | $730,922 | $782,693 | | **Liabilities & Equity** | | | | Total current liabilities | $89,130 | $87,076 | | Total liabilities | $134,803 | $134,766 | | Total shareholders' equity | $596,119 | $647,927 | Condensed Consolidated Statements of Operations (in thousands) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Total revenue | $26,488 | $7,889 | | Research and development | $80,116 | $38,584 | | General and administrative | $22,112 | $16,114 | | Operating loss | $(75,740) | $(46,809) | | Net loss | $(96,474) | $(34,456) | | Net loss per share (basic and diluted) | $(1.40) | $(0.59) | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(96,461) | $(44,388) | | Net cash provided by (used in) investing activities | $(8,715) | $(12,079) | | Net cash provided by financing activities | $6,743 | $30,156 | | Net decrease in cash | $(96,135) | $(26,089) | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the basis of the financial statements, confirming the company's ability to continue as a going concern - The company operates as a single reportable segment focused on the discovery and development of innovative therapeutics. The Chief Operating Decision Maker (CODM) evaluates performance based on expenses by segment and operating earnings[33](index=33&type=chunk) - Management evaluated conditions and events and did not identify substantial doubt about the Company's ability to continue as a going concern within one year from the date the financial statements were issued[32](index=32&type=chunk) Collaboration Revenue Breakdown (Q1 2025, in thousands) | Collaborator | Upfront Payments | Reimbursement Revenue | Total Q1 2025 Revenue | | :--- | :--- | :--- | :--- | | Incyte | $4,135 | $723 | $4,858 | | Lilly | $166 | $4 | $170 | | Gilead | $2,359 | $0 | $2,359 | | PTx | $260 | $379 | $639 | | Biohaven | $5,122 | $0 | $5,122 | | **Total Collaboration Revenue** | **$12,042** | **$1,106** | **$13,148** | - In Q1 2025, the company recognized **$13.3 million** in commercial material revenue and **$9,000** in royalty revenue from its license agreement with Partner Therapeutics (PTx) for zenocutuzumab[67](index=67&type=chunk)[91](index=91&type=chunk) - The company is engaged in patent litigation. It filed a complaint against Xencor, Inc. for patent infringement in August 2024. Separately, Xencor filed petitions for inter partes review (IPR) against two of Merus's U.S. patents in February 2025[47](index=47&type=chunk)[48](index=48&type=chunk)[341](index=341&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial performance, highlighting a significant year-over-year revenue increase to $26.5 million in Q1 2025 [Overview and Clinical Programs](index=28&type=section&id=Overview%20and%20Clinical%20Programs) Merus is a clinical-stage oncology company using its proprietary Biclonics® and Triclonics® platforms to develop multispecific antibody therapeutics - The FDA has granted accelerated approval for **BIZENGRI® (zenocutuzumab-zbco)** for adults with advanced NRG1 gene fusion positive pancreatic or non-small cell lung cancer (NSCLC)[103](index=103&type=chunk)[114](index=114&type=chunk) - **Petosemtamab (MCLA-158)** is advancing in two Phase 3 registrational trials for HNSCC (LiGeR-HN1 and LiGeR-HN2) and a Phase 2 trial for mCRC, with initial mCRC data expected in the second half of 2025[108](index=108&type=chunk)[113](index=113&type=chunk) - **MCLA-129** is being investigated in a Phase 1/2 trial for METex14 NSCLC and in combination with chemotherapy for 2L+ EGFR mutant NSCLC[117](index=117&type=chunk)[118](index=118&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) For Q1 2025, total revenue increased by $18.6 million year-over-year to $26.5 million, driven by commercial material revenue and new collaborations Comparison of Operating Results (in millions) | Account | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Total Revenue | $26.5 | $7.9 | $18.6 | | Research and Development Expense | $80.1 | $38.6 | $41.5 | | General and Administrative Expense | $22.1 | $16.1 | $6.0 | | Operating Loss | $(75.7) | $(46.8) | $(28.9) | | Total Other Income (Loss), Net | $(18.9) | $13.5 | $(32.4) | | Net Loss | $(96.5) | $(34.5) | $(62.0) | - The increase in R&D expense was primarily driven by a **$35.6 million** rise in clinical trial support from contract manufacturing and research organizations, mostly related to the petosemtamab clinical trials[126](index=126&type=chunk) - The significant negative change in 'Other Income (Loss), Net' was primarily due to a **$24.3 million** foreign exchange loss in Q1 2025, compared to an **$8.6 million** gain in Q1 2024[128](index=128&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, Merus held $638.2 million in cash, cash equivalents, and marketable securities - As of March 31, 2025, the company had **$638.2 million** in cash, cash equivalents, and marketable securities[133](index=133&type=chunk) - Based on the current operating plan, the company expects its existing cash and investments will be sufficient to fund operations into **2028**[140](index=140&type=chunk) Summary of Cash Flows (in millions) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(96.5) | $(44.4) | | Net cash provided by (used in) investing activities | $(8.7) | $(12.1) | | Net cash provided by financing activities | $6.7 | $30.2 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company identifies its main market risks as changes in interest rates, foreign exchange rates, and inflation - The primary market risk is foreign currency exchange risk between the U.S. dollar and the euro, as a significant portion of operating costs are denominated in euros[147](index=147&type=chunk) - A hypothetical **15% weakening** of the U.S. dollar against the euro would have increased the net loss for Q1 2025 by approximately **$15.2 million**[147](index=147&type=chunk) - Interest rate risk is considered minimal due to the short-term nature of the company's investment portfolio, which primarily consists of investments with maturities of less than 24 months[146](index=146&type=chunk) [Item 4. Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Based on an evaluation conducted by management, the company's disclosure controls and procedures were deemed effective as of March 31, 2025 - Management, including the principal executive officer and principal financial officer, concluded that the company's disclosure controls and procedures were effective as of March 31, 2025[150](index=150&type=chunk) - There were no material changes in the company's internal control over financial reporting during the quarter ended March 31, 2025[151](index=151&type=chunk) PART II — OTHER INFORMATION [Item 1. Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) This section states that the company is not currently a party to any material legal proceedings, referring to Note 6 for details - The company refers to Note 6, "Commitments and Contingencies," for information on legal proceedings. Note 6 details a patent infringement lawsuit Merus filed against Xencor, Inc. and a related inter partes review (IPR) petition filed by Xencor, as well as a patent opposition proceeding with Kymab Limited[152](index=152&type=chunk)[47](index=47&type=chunk)[49](index=49&type=chunk) [Item 1A. Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) This section provides an extensive overview of the risks facing the company, including financial losses, dependence on candidates, and IP risks [Risks Related to Our Business and Industry](index=40&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Industry) This subsection outlines fundamental business risks, emphasizing the company's history of significant net losses and the need for future funding - The company has incurred significant losses since inception, with an accumulated deficit of **$1,064.9 million** as of March 31, 2025, and expects to incur losses for the foreseeable future[154](index=154&type=chunk) - The company will require substantial additional funding to complete the development of its antibody candidates. While existing cash is expected to fund operations into **2028**, this estimate is based on assumptions that may prove wrong[159](index=159&type=chunk)[160](index=160&type=chunk) - The business heavily depends on the success of its antibody candidates, which require significant further development, regulatory approval, and commercialization efforts[163](index=163&type=chunk) [Risks Related to the Development and Clinical Testing of Our Antibody Candidates](index=47&type=section&id=Risks%20Related%20to%20the%20Development%20and%20Clinical%20Testing%20of%20Our%20Antibody%20Candidates) This subsection details the inherent risks of drug development, including lengthy, expensive, and uncertain clinical trials with potential for adverse side effects - Clinical drug development is a lengthy, expensive process with uncertain outcomes, and failure can occur at any time. Early positive results are not predictive of later-stage success[184](index=184&type=chunk) - Antibody candidates may cause serious or undesirable side effects, which could delay or prevent marketing approval. Adverse reactions have been observed in trials for zenocutuzumab, petosemtamab, and MCLA-129[198](index=198&type=chunk)[199](index=199&type=chunk)[200](index=200&type=chunk) - **BIZENGRI®** received accelerated approval, which is contingent upon verification of clinical benefit in confirmatory trials. Failure to do so, or to comply with post-marketing requirements, could lead the FDA to withdraw the approval[228](index=228&type=chunk)[230](index=230&type=chunk) [Risks Related to Commercialization of Our Antibody Candidates](index=58&type=section&id=Risks%20Related%20to%20Commercialization%20of%20Our%20Antibody%20Candidates) This subsection addresses the challenges of bringing products to market, including intense competition and the need for market acceptance and reimbursement - The biopharmaceutical industry is highly competitive, and competitors may develop safer, more effective, or less expensive products more rapidly[279](index=279&type=chunk)[280](index=280&type=chunk) - Successful commercialization depends on adequate coverage and reimbursement from government and private payors, which is uncertain and subject to increasing pricing pressures[289](index=289&type=chunk) - The company has limited marketing, sales, and distribution infrastructure and relies on its licensee, PTx, for the U.S. commercialization of **BIZENGRI®**. It may not be successful in building these capabilities for other candidates[298](index=298&type=chunk)[300](index=300&type=chunk) [Risks Related to Our Dependence on Third Parties](index=68&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) The company's business model is heavily reliant on third parties for clinical trials, manufacturing, and strategic collaborations - The company relies on third-party CROs to conduct clinical trials and CMOs to manufacture antibody candidates. Failure by these parties to perform their duties or meet regulatory standards could delay or halt development[307](index=307&type=chunk)[333](index=333&type=chunk) - Key collaborations with Incyte, Lilly, Gilead, Biohaven, and PTx are critical. The company is dependent on these partners for development and commercialization activities, and termination or underperformance by a partner would adversely affect the business[313](index=313&type=chunk)[319](index=319&type=chunk)[323](index=323&type=chunk) [Risks Related to Intellectual Property and Information Technology](index=78&type=section&id=Risks%20Related%20to%20Intellectual%20Property%20and%20Information%20Technology) This subsection highlights significant IP and IT risks, including challenges to patents, infringement claims, and vulnerability to cyberattacks - The company's success depends on protecting its intellectual property, but patents may be challenged, narrowed, or invalidated. For example, Xencor has filed IPR petitions challenging two of the company's U.S. patents[339](index=339&type=chunk)[341](index=341&type=chunk)[342](index=342&type=chunk) - The company may be required to litigate to defend its patents or against claims that it infringes third-party IP, which is costly and time-consuming. The company has filed a patent infringement lawsuit against Xencor[348](index=348&type=chunk)[358](index=358&type=chunk) - Information technology systems are vulnerable to security breaches and cyberattacks, which could lead to the loss of trade secrets, disruption of clinical trials, and significant financial and reputational harm[385](index=385&type=chunk)[386](index=386&type=chunk) [Risks Related to Employee Matters and Managing Growth](index=86&type=section&id=Risks%20Related%20to%20Employee%20Matters%20and%20Managing%20Growth) The company's future success is dependent on its ability to retain key senior management and scientific personnel and to recruit additional qualified staff - Success depends on retaining key personnel. The loss of senior leaders could delay R&D activities. Competition for qualified personnel is intense[388](index=388&type=chunk) - Recent senior management changes, including the departures of the CBO, CMO, and CDO, and the appointments of a new CMO and CPO, require orderly transitions to avoid business disruption[389](index=389&type=chunk) [Risks Related to Our Common Shares](index=87&type=section&id=Risks%20Related%20to%20Our%20Common%20Shares) This subsection details risks for investors in the company's common shares, including price volatility, anti-takeover provisions, and tax consequences - The company's share price is highly volatile and subject to fluctuation from factors like clinical trial results, regulatory decisions, and market conditions[407](index=407&type=chunk) - Anti-takeover provisions under Dutch law and in the company's articles of association may deter acquisition bids or prevent changes in the board of directors[392](index=392&type=chunk)[394](index=394&type=chunk) - The company may be classified as a Passive Foreign Investment Company (PFIC) for U.S. federal income tax purposes, which could result in adverse tax consequences for U.S. investors[402](index=402&type=chunk) - As a Dutch company, it may be difficult for U.S. shareholders to enforce judgments from U.S. courts against the company in the Netherlands[400](index=400&type=chunk) [Item 5. Other Information](index=95&type=section&id=Item%205.%20Other%20Information) This section discloses that on March 20, 2025, Peter B. Silverman established a Rule 10b5-1 trading plan for the potential sale of common shares - On March 20, 2025, Peter B. Silverman, the Company's Chief Operating Officer and General Counsel, adopted a Rule 10b5-1 trading plan for the sale of up to **117,500** common shares until June 19, 2026[424](index=424&type=chunk) [Item 6. Exhibits](index=95&type=section&id=Item%206.%20Exhibits) This section provides a list of the exhibits filed as part of the Quarterly Report on Form 10-Q, including key agreements and certifications - The report includes several exhibits, notably the License Agreement with Partner Therapeutics, Inc. dated November 27, 2024, and certifications by the CEO and CFO pursuant to Sarbanes-Oxley Act Sections 302 and 906[426](index=426&type=chunk)

The market expects Merus N.V. (MRUS) to deliver a year-over-year decline in earnings on lower revenues when it reports results for the quarter ended March 2025. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss ...

Core Insights - Merus N.V. announced the acceptance of an abstract for the presentation of interim clinical data on petosemtamab in combination with pembrolizumab for the treatment of PD-L1+ recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) at the 2025 ASCO Annual Meeting [1][2] - The presentation will include data from a phase 2 trial involving 45 patients, showcasing early clinical efficacy and safety data [2][3] - The company believes petosemtamab has the potential to be a first and best-in-class treatment for r/m HNSCC, demonstrating substantial clinical activity superior to historical controls across multiple efficacy endpoints [3] Company Overview - Merus N.V. is focused on developing innovative full-length multispecific antibodies and antibody drug conjugates, referred to as Biclonics, Triclonics, and ADClonics [1][10] - Petosemtamab (MCLA-158) is a Biclonics low-fucose human full-length IgG1 antibody targeting EGFR and LGR5, designed to exhibit multiple mechanisms of action [6] - The company is conducting a phase 3 trial (LiGeR-HN1) to evaluate the safety and efficacy of petosemtamab in combination with pembrolizumab compared to pembrolizumab alone in r/m HNSCC patients [9] Industry Context - HNSCC is the sixth most common cancer globally, with over 930,000 new cases and more than 465,000 deaths reported in 2020 [8] - The incidence of HNSCC is expected to rise by 30%, surpassing 1 million new cases annually by 2030, indicating a growing need for effective treatment options [8]

Group 1 - The oncology drug development landscape is highly competitive, necessitating innovation and clinical validation [1] - Companies that utilize novel platform technologies to develop differentiated therapies are more likely to succeed in this space [1] - Merus focuses on Biclonics and Multiclonics bispecific and multispecific antibodies, positioning itself as a key player in the oncology sector [1] Group 2 - The emphasis on high-growth companies indicates a trend towards sectors that are expected to experience exponential expansion [1] - There is a strong belief in the potential of innovation to generate substantial returns in the investment landscape [1]

Core Viewpoint - Merus N.V. is set to participate in the 24th Annual Needham Virtual Healthcare Conference, highlighting its focus on innovative oncology treatments [1]. Company Overview - Merus is an oncology company specializing in the development of full-length human bispecific and trispecific antibody therapeutics, known as Multiclonics [3]. - Multiclonics are produced using industry-standard processes and 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 engage in a fireside chat at the conference on April 8, 2025, at 8:45 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. 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]