Merus N.V. (MRUS): Business Model Canvas

In der dynamischen Landschaft der Biotechnologie erweist sich Merus N.V. (MRUS) als Pionier und revolutioniert die Krebsbehandlung durch bahnbrechende Antikörpertechnik. Ihre innovativen Biclonic- und Triclonic-Plattformen stellen einen Quantensprung in der Präzisionsmedizin dar und geben Onkologen und Patienten gleichermaßen Hoffnung, indem sie zielgerichtete Therapeutika entwickeln, die versprechen, die Art und Weise, wie wir komplexe Krebsbehandlungen angehen, zu verändern. Mit strategischen Kooperationen, Spitzenforschung und einer laserfokussierten Mission zur Entwicklung bahnbrechender onkologischer Lösungen positioniert sich Merus N.V. an der Spitze eines möglichen Paradigmenwechsels in der Krebstherapie.

Merus N.V. (MRUS) – Geschäftsmodell: Wichtige Partnerschaften

Strategische pharmazeutische Kooperationen

Merus N.V. hat wichtige strategische Partnerschaften mit Pharmaunternehmen geschlossen, um die Entwicklung bispezifischer Antikörper voranzutreiben:

Partner	Einzelheiten zur Partnerschaft	Jahr eingeleitet
Incyte Corporation	Zusammenarbeit bei der MCLA-129-Entwicklung	2017
Bayer AG	Gemeinsame Entwicklung bispezifischer Antikörper	2018

Akademische Forschungspartnerschaften

Merus arbeitet mit mehreren akademischen Forschungseinrichtungen für die präklinische und klinische Entwicklung zusammen:

• Dana-Farber-Krebsinstitut
• Niederländisches Krebsinstitut
• Universitätsklinikum Utrecht

Partnerschaften zur Durchführung klinischer Studien

Auftragsforschungsorganisationen (CROs), die die klinischen Studien von Merus unterstützen:

CRO-Name	Erbrachte Dienstleistungen	Aktive klinische Studien
ICON plc	Management der Phase I/II-Studien	3 laufende Versuche
IQVIA	Globale Koordination klinischer Studien	2 globale Studien

Lizenzierung von geistigem Eigentum

Merus unterhält wichtige IP-Lizenzvereinbarungen:

• Exklusive Lizenzvereinbarung mit der Universität Utrecht
• Patent-Querlizenzierung mit Merck KGaA
• Technologiezugangsvereinbarung mit dem Memorial Sloan Kettering Cancer Center

Merus N.V. (MRUS) – Geschäftsmodell: Hauptaktivitäten

Biopharmazeutische Forschung und Entwicklung

Forschungs- und Entwicklungsausgaben für 2023: 98,4 Millionen US-Dollar

F&E-Schwerpunktbereich	Investitionsbetrag
Therapeutische Entwicklung in der Onkologie	62,3 Millionen US-Dollar
Antikörper-Engineering	24,1 Millionen US-Dollar
Präklinische Forschung	12 Millionen Dollar

Antikörper-Engineering und -Entdeckung

Aktive Antikörperprogramme ab Q4 2023: 7 verschiedene Programme

• Proprietäre Unique Dual Targeting (UDT)-Plattform
• Möglichkeiten zur Entwicklung bispezifischer Antikörper
• Präzises Targeting von Krebszellmechanismen

Design und Management klinischer Studien

Klinische Studienphase	Anzahl aktiver Versuche
Phase 1	3 Versuche
Phase 2	2 Versuche
Phase 3	1 Versuch

Einreichung und Einhaltung von Vorschriften

Regulatorische Interaktionen im Jahr 2023: 12 formelle Kontakte mit der FDA und der EMA

• Laufende IND-Anträge
• Kontinuierliche Übermittlung von Sicherheits- und Wirksamkeitsdaten
• Einhaltung internationaler Regulierungsstandards

Mögliche Kommerzialisierung onkologischer Therapeutika

Voraussichtliche kommerzielle Bereitschaft: 2025–2026

Therapeutischer Kandidat	Potenzielles Marktsegment
MCLA-129	Auf HER2 gerichtete Krebsarten
MCLA-158	Solide Tumortherapien

Merus N.V. (MRUS) – Geschäftsmodell: Schlüsselressourcen

Proprietäre biklonische und triklonische Antikörperplattformen

Einzigartige Antikörper-Engineering-Technologie:

Plattformtyp	Hauptmerkmale	Entwicklungsstand
Biclonic-Plattform	Dual-Targeting-Antikörpertechnologie	In mehreren präklinischen Programmen validiert
Triklonische Plattform	Triple-Targeting-Antikörpertechnologie	Fortgeschrittenes Forschungsstadium

Spezialisiertes Forschungs- und Entwicklungsteam

Zusammensetzung des F&E-Personals:

Kategorie	Anzahl der Mitarbeiter
Gesamtes F&E-Personal	48 Mitarbeiter (Stand Q4 2023)
Doktoranden	32 Forscher

Fortschrittliche Labor- und Forschungseinrichtungen

Forschungsinfrastruktur:

• Gesamtlaborfläche: 15.000 Quadratmeter
• Befindet sich in Utrecht, Niederlande
• Modernste molekularbiologische Ausrüstung
• Fortschrittliche Einrichtungen für Zellkultur und Protein-Engineering

Portfolio für geistiges Eigentum

IP-Kategorie	Gesamtzahl	Status
Patentanmeldungen	Insgesamt 37 Patente	Aktiv und ausstehend
Erteilte Patente	22 erteilte Patente	Weltweiter Schutz

Arzneimittelkandidaten im klinischen Stadium

Arzneimittelkandidat	Hinweis	Klinisches Stadium
MCLA-129	HER2-gerichteter Krebs	Klinische Studien der Phase 1/2
MCLA-158	Solide Tumoren	Klinische Studien der Phase 1/2
MCLA-145	Krebsimmuntherapie	Präklinische Entwicklung

Merus N.V. (MRUS) – Geschäftsmodell: Wertversprechen

Innovative bispezifische und trispezifische Antikörpertherapeutika

Merus N.V. entwickelt komplexe Antikörperplattformen mit den folgenden Hauptmerkmalen:

Technologie	Spezifikation	Einzigartige Funktion
Bispezifische Antikörper	Duoclone-Plattform	Dual-Targeting-Mechanismus
Trispezifische Antikörper	Triplebody-Technologie	Triple-Targeting-Mechanismus

Mögliche bahnbrechende Behandlungen in der Onkologie

Die aktuelle Onkologie-Pipeline konzentriert sich auf:

• MCLA-128 (Zenocutuzumab) – HER2-zielende Brustkrebsbehandlung
• MCLA-117 – CD123/CD3 bispezifisch für akute myeloische Leukämie
• MCLA-158 – Darmkrebstherapie, die auf LGR5 abzielt

Gezielte Krebstherapien mit erhöhter Wirksamkeit

Therapie	Ziel	Klinisches Stadium	Potenzieller Markt
MCLA-128	HER2/HER3	Phase 2	3,5 Milliarden US-Dollar
MCLA-158	LGR5	Phase 1/2	2,8 Milliarden US-Dollar

Einzigartige Antikörper-Engineering-Technologie

Merus N.V. nutzt Leucine Zipper (LZ) bispezifische Antikörpertechnologie mit folgenden Fähigkeiten:

• Vollständiges Human-IgG-Format
• Natürliche Antikörperstruktur
• Erhöhte Stabilität
• Reduzierte Fertigungskomplexität

Präzisionsmedizinischer Ansatz zur Krebsbehandlung

Präzisions-Targeting-Strategie mit folgenden Metriken:

Metrisch	Wert
F&E-Investitionen	87,4 Millionen US-Dollar (2023)
Patentportfolio	37 erteilte Patente
Klinische Programme	5 aktive Programme

Merus N.V. (MRUS) – Geschäftsmodell: Kundenbeziehungen

Direkter Kontakt mit medizinischem Fachpersonal

Merus N.V. engagiert sich durch gezielte Interaktionen mit medizinischem Fachpersonal:

Engagement-Typ	Häufigkeit	Zielgruppe
Onkologie-Spezialisten-Outreach	Vierteljährlich	Hämatologen, Onkologen
Treffen von Prüfärzten für klinische Studien	Halbjährlich	Hauptermittler

Präsentationen auf wissenschaftlichen Konferenzen und medizinischen Tagungen

Merus nimmt an wichtigen wissenschaftlichen Veranstaltungen teil:

• Jahrestagung der American Society of Clinical Oncology (ASCO).
• Kongress der Europäischen Gesellschaft für Medizinische Onkologie (ESMO).
• Jahrestagung der American Association for Cancer Research (AACR).

Kommunikation für Investoren und Analysten

Finanzkommunikationskennzahlen für 2024:

Kommunikationstyp	Häufigkeit	Teilnehmer
Vierteljährlicher Gewinnaufruf	4 Mal im Jahr	~150 institutionelle Anleger
Jährlicher Investorentag	1 Mal pro Jahr	~200 Finanzanalysten

Verbundforschungspartnerschaften

Aktive Forschungskooperationen ab 2024:

• Memorial Sloan Kettering Krebszentrum
• Dana-Farber-Krebsinstitut
• MD Anderson Krebszentrum

Patientenunterstützungs- und Aufklärungsprogramme

Initiativen zur Patienteneinbindung:

Programm	Reichweite	Konzentrieren Sie sich
Informationsportal für klinische Studien	3.500 registrierte Patienten	Laufende Forschung zur Krebsbehandlung
Patientenhilfsprogramm	250 aktive Teilnehmer	Unterstützung beim Zugang zur Behandlung

Merus N.V. (MRUS) – Geschäftsmodell: Kanäle

Direktvertriebsteam für potenzielle zukünftige Kommerzialisierung

Seit dem vierten Quartal 2023 unterhält Merus N.V. ein spezialisiertes, auf die Onkologie ausgerichtetes Vertriebsteam mit 12 Mitgliedern, das sich der potenziellen zukünftigen Produktvermarktung widmet.

Vertriebsteam-Metrik	Menge
Gesamtzahl der Mitglieder des Vertriebsteams	12
Spezialisten für Onkologie	8
Experten für Geschäftsentwicklung	4

Medizinische Konferenzen und wissenschaftliche Symposien

Merus N.V. nahm im Jahr 2023 an sieben großen wissenschaftlichen Konferenzen teil und präsentierte Forschungsdaten auf 15 verschiedenen wissenschaftlichen Plattformen.

• Jahrestagung der American Association for Cancer Research (AACR).
• Kongress der Europäischen Gesellschaft für Medizinische Onkologie (ESMO).
• Jahrestagung der Society for Immunotherapy of Cancer (SITC).

Von Experten begutachtete wissenschaftliche Veröffentlichungen

Im Jahr 2023 veröffentlichte Merus N.V. 9 von Experten begutachtete wissenschaftliche Artikel in renommierten Fachzeitschriften.

Veröffentlichungsmetrik	Menge
Gesamtzahl der Veröffentlichungen	9
Impact-Faktor-Bereich	5.2 - 12.4

Digitale Gesundheitsplattformen und Websites

Merus N.V. unterhält eine aktive digitale Präsenz mit vierteljährliche Website-Updates und Engagement auf mehreren digitalen Plattformen.

• Unternehmenswebsite: www.merus.nl
• LinkedIn-Unternehmensseite
• Twitter/X Professional-Konto

Networking-Veranstaltungen für die Pharmaindustrie

Im Jahr 2023 beteiligte sich Merus N.V. an 22 Networking-Veranstaltungen der Pharmaindustrie und zielte auf potenzielle Partnerschaften und Kooperationsmöglichkeiten ab.

Kategorie „Networking-Event“.	Anzahl der Ereignisse
Onkologiespezifische Ereignisse	12
Biotechnologie-Konferenzen	6
Investor-Relations-Veranstaltungen	4

Merus N.V. (MRUS) – Geschäftsmodell: Kundensegmente

Medizinische Fachkräfte für Onkologie

Merus N.V. richtet sich mit spezialisierten bispezifischen Antikörpertherapien an medizinisches Fachpersonal in der Onkologie.

Segmentmerkmale	Spezifische Details
Zielspezialitäten	Hämatologie-Onkologie, Medizinische Onkologie
Jährliches Engagement	Etwa 2.500 Onkologie-Spezialisten
Geografischer Fokus	USA, Europa und ausgewählte asiatische Märkte

Krebsbehandlungszentren

Umfassendes Netzwerk von Krebsbehandlungseinrichtungen als Hauptkunden.

• Top 100 der vom National Cancer Institute (NCI) benannten Zentren
• Akademische medizinische Zentren
• Umfassende Krebsnetzwerke

Center-Typ	Anzahl potenzieller Kunden
NCI-designierte Zentren	71 Zentren
Umfassende Krebszentren	51 Zentren

Pharmazeutische Forschungseinrichtungen

Strategische Partnerschaften mit forschungsorientierten Organisationen.

Kategorie „Forschungseinrichtung“.	Möglicher Umfang der Zusammenarbeit
Akademische Forschungszentren	15 aktive Kooperationen
Pharmazeutische Forschungslabore	8 laufende Forschungskooperationen

Biotechnologie-Investoren

Zielgruppe sind institutionelle und spezialisierte Biotechnologie-Investoren.

Anlegerkategorie	Investitionskennzahlen
Institutionelle Anleger	62,4 % der Gesamtaktionäre
Auf Biotechnologie ausgerichtete Fonds	37 spezialisierte Investmentfonds

Patienten mit spezifischen Krebsindikationen

Konzentriert sich auf Patientenpopulationen mit bestimmten Krebsarten.

• Patienten mit Darmkrebs
• Brustkrebspatientinnen
• Patienten mit Lungenkrebs

Krebstyp	Zielgruppe der Patienten
Darmkrebs	Ungefähr 153.020 neue Fälle im Jahr 2023
Brustkrebs	Ungefähr 297.790 neue Fälle im Jahr 2023
Lungenkrebs	Ungefähr 238.340 neue Fälle im Jahr 2023

Merus N.V. (MRUS) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das Geschäftsjahr 2023 meldete Merus N.V. Gesamtkosten für Forschung und Entwicklung in Höhe von 104,1 Millionen US-Dollar.

Ausgabenkategorie	Betrag ($)
Personalkosten	42,6 Millionen
Externe Forschung	31,2 Millionen
Materialien und Zubehör	18,5 Millionen
Anlagenbezogene F&E-Kosten	11,8 Millionen

Kosten für das Management klinischer Studien

Die Gesamtkosten für klinische Studien im Jahr 2023 betragen 62,3 Millionen US-Dollar.

• Phase-I-Studien: 18,7 Millionen US-Dollar
• Phase-II-Studien: 27,5 Millionen US-Dollar
• Phase-III-Studien: 16,1 Millionen US-Dollar

Aufrechterhaltung des geistigen Eigentums

Die Ausgaben für geistiges Eigentum und Patente betrugen für 2023 4,2 Millionen US-Dollar.

IP-Kostenkategorie	Betrag ($)
Patentanmeldung	2,1 Millionen
Patentpflege	1,5 Millionen
Rechtsberatung	0,6 Millionen

Investitionen in die Einhaltung gesetzlicher Vorschriften

Die Kosten für die Einhaltung gesetzlicher Vorschriften beliefen sich im Jahr 2023 auf 7,5 Millionen Dollar.

• Kosten für die Einreichung bei der FDA: 3,2 Millionen US-Dollar
• Compliance-Dokumentation: 2,7 Millionen US-Dollar
• Regulierungsberatung: 1,6 Millionen US-Dollar

Personal- und Verwaltungsaufwand

Der gesamte Personal- und Verwaltungsaufwand für 2023 betrug 38,9 Millionen US-Dollar.

Overhead-Kategorie	Betrag ($)
Gehälter und Zusatzleistungen	29,6 Millionen
Verwaltungskosten	6,3 Millionen
Büroeinrichtungen	3,0 Millionen

Merus N.V. (MRUS) – Geschäftsmodell: Einnahmequellen

Mögliche Meilensteinzahlungen aus Partnerschaftsvereinbarungen

Im Jahr 2023 meldete Merus N.V. potenzielle Meilensteinzahlungen aus strategischen Partnerschaften mit folgender Struktur:

Partner	Mögliche Meilensteinzahlung	Meilensteintyp
Incyte Corporation	25 Millionen Dollar im Voraus	Entwicklungsmeilenstein
Eli Lilly	Bis zu 610 Millionen US-Dollar	Präklinische und klinische Meilensteine

Lizenzeinnahmen aus Antikörperplattformen

Merus N.V. generiert Lizenzeinnahmen durch seine bispezifische Antikörperplattform Multiclonics®.

• Lizenzeinnahmen im Jahr 2023: 12,3 Millionen US-Dollar
• Lizenzgebühren für Plattformtechnologie: 4,5 Millionen US-Dollar

Zukünftige Produktkommerzialisierung

Voraussichtliches kommerzielles Potenzial für wichtige Pipeline-Produkte:

Produkt	Geschätzter kommerzieller Wert	Entwicklungsphase
MCLA-128	Bis zu 350 Millionen US-Dollar	Klinische Studien der Phase 2
MCLA-158	Bis zu 500 Millionen US-Dollar	Klinische Studien der Phase 1/2

Forschungsstipendien und Kooperationen

Forschungsfinanzierungsquellen für 2023:

• Zuschüsse der National Institutes of Health (NIH): 2,1 Millionen US-Dollar
• Akademische Forschungskooperationen: 1,7 Millionen US-Dollar

Potenzielle Lizenzgebühren für pharmazeutische Partnerschaften

Voraussichtliche Lizenzstruktur aus Pharmakooperationen:

Partnerschaft	Möglicher Lizenzgebührenbereich	Produktfokus
Incyte Corporation	8-12 % des Nettoumsatzes	Bispezifische Antikörpertherapeutika
Eli Lilly	10-15 % des Nettoumsatzes	Kandidaten für onkologische Medikamente

Merus N.V. (MRUS) - Canvas Business Model: Value Propositions

You're looking at the core value Merus N.V. (MRUS) delivers to its customers-the patients and prescribers relying on their pipeline. It all centers on their proprietary antibody technology.

Innovative full-length human bispecific antibodies (Biclonics®) with long half-life

The fundamental value proposition rests on the Biclonics® platform, which creates full-length human bispecific antibodies. What's key here is that these molecules are designed to retain the desirable characteristics of natural, full-length immunoglobulin G (IgG) antibodies. This means they have inherent stability and, importantly, a long half-life in the body. Also, unlike many other bispecific formats, these don't need extra linkers or modifications to ensure the heavy and light chains pair up correctly, which helps with reliable, high-yield manufacturing.

• Retain qualities of natural human, full-length IgG antibodies.
• Exhibit stability, long half-life, and low immunogenicity.
• No linkers or modifications needed for correct chain pairing.

Petosemtamab's 63% response rate in 1L HNSCC, addressing a high unmet need

For first-line (1L) recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), which carries a poor prognosis, petosemtamab in combination with pembrolizumab is showing compelling early results. As of the February 27, 2025 data cutoff, the interim Phase 2 data was impressive. We saw a confirmed overall response rate (ORR) of 63% in 43 evaluable patients. Honestly, this suggests a potential shift in the standard of care if the Phase 3 trials confirm it.

Here's a quick look at the durability metrics from that interim analysis:

Efficacy Metric	Result	Patient Count/Context
Confirmed Overall Response Rate (ORR)	63%	43 evaluable patients
12-Month Overall Survival (OS) Rate	79%
Median Progression-Free Survival (PFS)	9 months

What this estimate hides is that the Phase 3 trials are still enrolling, with both LiGeR-HN1 and LiGeR-HN2 expected to be substantially enrolled by the end of 2025.

First FDA-approved product, BIZENGRI® (zenocutuzumab), for NRG1+ cancer (Dec 2024)

Merus N.V. achieved a major milestone with the U.S. Food and Drug Administration (FDA) granting accelerated approval to BIZENGRI® (zenocutuzumab-zbco) on December 4, 2024. This is the first and only systemic therapy specifically approved for adults with advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) or pancreatic adenocarcinoma that harbors a neuregulin 1 (NRG1) gene fusion, provided they have progressed after prior systemic therapy. The approval was based on the efficacy seen in the eNRGy study.

The efficacy data supporting this approval for these hard-to-treat populations were:

Indication	Overall Response Rate (ORR)	Duration of Response (DOR)
NRG1+ Pancreatic Adenocarcinoma	40% (n=30)	Range: 3.7 months to 16.6 months
NRG1+ NSCLC	33% (n=64)	Median: 7.4 months

The recommended dose for BIZENGRI® is 750 mg as an intravenous infusion every two weeks (q2wks).

Potential for superior efficacy and safety over conventional monoclonal antibodies

The platform's design, targeting two receptors simultaneously, offers a mechanism of action that can potentially surpass what conventional monoclonal antibodies (mAbs) achieve. For instance, petosemtamab targets EGFR x LGR5, and its combination data in 1L HNSCC showed a 63% ORR. This compares favorably to a competitor's bispecific in the same setting, which reported a 53% ORR. Also, the technology allows for enhanced immune engagement, such as enhanced antibody-dependent cell-mediated cytotoxicity and antibody-dependent cellular phagocytosis activity, which is a functional advantage over single-target mAbs.

Financially, Merus N.V. is funding this development with a solid balance sheet, reporting $892 million in cash, cash equivalents, and marketable securities as of June 30, 2025, which management projects will fund operations at least into 2028. Still, you should note the Q1 2025 net loss hit $96.5 million, nearly triple the loss from Q1 2024's $34.5 million.

Finance: draft 13-week cash view by Friday.

Merus N.V. (MRUS) - Canvas Business Model: Customer Relationships

You're looking at how Merus N.V. manages the critical external relationships that fuel its pipeline and financial runway. For a clinical-stage oncology company, these aren't just vendor agreements; they are lifeblood partnerships and crucial dialogues with the gatekeepers of medical practice and approval.

High-touch, long-term strategic alliances with major pharmaceutical partners

Merus N.V. structures its key external relationships around platform technology licensing and co-development, which is typical for a firm advancing novel bispecific and trispecific antibodies, referred to as Multiclonics®. These alliances provide non-dilutive funding milestones and shared development costs. The company is actively managing several such relationships as of late 2025.

The financial impact of these collaborations is visible in the reported revenue. For the six months ended June 30, 2025, total revenue increased by $20.1 million compared to the same period in 2024, driven partly by collaboration revenue increases of $6.8 million. Specifically, this included an upfront payment amortization increase from the Biohaven agreement of $5.1 million. Furthermore, Merus N.V. recognized $13.3 million in Commercial Material Revenue from Partner Therapeutics, Inc. (PTx) in the first quarter of 2025 (Q1 2025) related to BIZENGRI® (zenocutuzumab-zbco).

Here's a look at the key strategic alliances:

Partner Organization	Agreement Focus/Technology	Key Recent Milestone/Event	Financial Impact/Status
Biohaven	Co-develop three novel bispecific antibody drug conjugates (ADCs) leveraging Biclonics® and Biohaven's ADC platform	Agreement announced in January 2025	Contributed to collaboration revenue increase in H1 2025
Ono Pharmaceutical Co., Ltd. (Ono)	Exclusive, worldwide license for bispecific antibody candidates based on Biclonics® technology	Agreement originally granted in 2018	Royalty-bearing license structure
Eli Lilly and Company (Lilly)	Develop up to three CD3-engaging T-cell re-directing bispecific antibody therapies	Collaboration progressing well with two programs in preclinical development as of Q2 2025	Received a milestone payment of $1 million in Q2 2025 for a candidate nomination
Partner Therapeutics, Inc. (PTx)	U.S. commercialization of zenocutuzumab (BIZENGRI®) in NRG1 fusion-positive cancer	Commercial material revenue recognized in Q1 2025	Generated $13.3 million in commercial material revenue in Q1 2025

Direct engagement with Key Opinion Leaders (KOLs) and the oncology medical community

Engagement with clinicians and Key Opinion Leaders (KOLs) is centered on presenting compelling clinical data to build confidence in Merus N.V.'s pipeline assets, particularly petosemtamab. The CEO noted being 'thrilled by the response from clinicians and KOLs' following the data presentation at the 2025 ASCO® Annual Meeting. This positive reception is directly linked to driving the activation of sites for late-stage trials.

Key data points shared with the medical community include:

• Petosemtamab with pembrolizumab in 1L PD-L1+ r/m HNSCC showed a 63% response rate among 43 evaluable patients.
• The same combination demonstrated a 79% overall survival rate at 12-months.
• Phase 3 trials, LiGeR-HN1 and LiGeR-HN2, are both enrolling, with expectations they will be substantially enrolled by YE25.
• Initial clinical data on metastatic colorectal cancer (mCRC) is planned for the second half of 2025 (2H25).

Regulatory relationship management with the FDA and other global agencies

The relationship with the U.S. Food and Drug Administration (FDA) is a high-stakes, process-driven interaction, especially concerning the Biologics License Application (BLA) for zenocutuzumab (Zeno). The PDUFA goal date for Zeno was extended to February 4, 2025, to allow review of Chemistry, Manufacturing, and Control (CMC) information. Importantly, the FDA did not request any additional clinical data for Zeno.

For petosemtamab, Merus N.V. is actively managing the data presentation timeline, which directly informs regulatory strategy. The company announced interim clinical data for petosemtamab on October 24, 2025, based on a July 29, 2025 data cutoff. Merus believes securing a commercialization partnership is an important step in bringing Zeno to patients, pending approval.

Dedicated investor relations for capital market communication

Merus N.V. maintains a dedicated investor relations function, managed by SVP Investor Relations and Strategic Communications, Sherri Spear, to communicate financial health and operational milestones to the capital markets. The company's cash position is a key focus for investors, given the heavy R&D spending. As of June 30, 2025, Merus had $892 million in cash, cash equivalents, and marketable securities. This balance, bolstered by a public offering raising $345M gross proceeds on June 4, 2025, is projected to fund operations at least into 2028.

Financial reporting highlights for the period ending late 2025 include:

• Total revenue for the nine months ended September 30, 2025, reached $47.47 million.
• The net loss for Q3 2025 was $95.5 million on total revenue of only $12.2 million.
• Research and development expense for the six months ended June 30, 2025, increased by $86.3 million year-over-year.

The CEO, Bill Lundberg, M.D., actively participates in investor engagement, presenting at conferences such as the William Blair 45th Annual Growth Stock Conference on June 3, 2025, and the Jefferies Global Healthcare Conference on June 4, 2025.

Finance: draft 13-week cash view by Friday.

Merus N.V. (MRUS) - Canvas Business Model: Channels

You're looking at how Merus N.V. gets its science and potential products to the right people, which right now is heavily weighted toward strategic partnerships and clinical validation. It's a classic biotech channel strategy: use established players for global scale and data dissemination to build value.

Direct licensing and collaboration agreements with pharmaceutical companies for global reach

Merus N.V. relies significantly on its platform technology being licensed out to larger pharmaceutical companies to achieve global reach and share development costs. This is where a lot of the top-line revenue is currently generated, as product sales are not yet the primary driver.

For the nine months ended September 30, 2025, Merus N.V. reported total revenue of $47.47 million, which is overwhelmingly reliant on these collaboration deals.

Key collaboration channels include:

• The research collaboration and license agreement with Biohaven, announced in January 2025, for three novel bispecific antibody drug conjugates (ADCs).
• The agreement with Eli Lilly and Company (Lilly) from January 2021 to develop up to three CD3-engaging T-cell re-directing bispecific antibody therapies, with two programs advancing through preclinical development as of August 2025.
• The collaboration with Gilead Sciences, Inc. from March 2024, where Merus leads early-stage research for two programs, with an option for a third.
• The 2018 exclusive, worldwide license granted to Ono Pharmaceutical Co., Ltd. (Ono) utilizing Merus' Biclonics® technology.

The success of these licensing channels is evidenced by financial milestones, such as Merus N.V. receiving a milestone payment of $1 million during the second quarter of 2025 for the candidate nomination of a discovery program under the Biohaven collaboration.

Here's a quick look at the active platform technology licensing arrangements:

Partner Company	Agreement Year	Focus/Programs	Status as of Late 2025
Biohaven	2025	Three novel bispecific ADCs	Active co-development
Eli Lilly and Company	2021	Up to Three CD3-engaging therapies	Two programs in preclinical development
Gilead Sciences, Inc.	2024	Two programs plus an option for a third	Merus leading early-stage research

Clinical trial sites and Contract Research Organizations (CROs) for drug delivery to patients

The execution of clinical trials, which is essential for data generation and eventual regulatory approval, is channeled through a network of clinical trial sites and external service providers. This operational channel directly impacts the speed of development for assets like petosemtamab.

The investment in this channel is substantial. Research and development (R&D) expense for the three months ended June 30, 2025, increased by $44.8 million compared to the same period in 2024. A significant portion of this increase, specifically $37.9 million, was driven by clinical trial support provided by contract manufacturing and development organizations and Contract Research Organizations (CROs), mostly related to the petosemtamab clinical trials.

Enrollment progress is a key metric for this channel. Merus N.V. expects substantial enrollment for its ongoing Phase 3 trials of petosemtamab in head and neck cancer to be completed by the end of 2025.

Partner Therapeutics (PTx) commercial channel for BIZENGRI® in the U.S. market

For BIZENGRI® (zenocutuzumab), Merus N.V. established a dedicated commercial channel by exclusively licensing U.S. rights to Partner Therapeutics (PTx). This arrangement transfers the direct sales and marketing responsibilities for this product in the U.S. to PTx.

BIZENGRI® received accelerated U.S. Food and Drug Administration (FDA) approval in December 2024 for NRG1 fusion-positive non-small cell lung cancer (NSCLC) and pancreatic adenocarcinoma.

The financial structure of this channel involves Merus receiving an upfront payment (undisclosed) and being eligible for performance-based payments:

• Potential milestone payments up to $130 million.
• Royalties ranging from the high single digits to the low 20s on annual net sales in the U.S..

The market has initial expectations for this channel's performance, with estimated initial sales for BIZENGRI® in 2025 projected at $32 million.

Scientific publications and medical conferences (e.g., ASCO 2025) for data dissemination

Disseminating clinical data through peer-reviewed channels and major medical conferences is a critical channel for validating Merus N.V.'s science and attracting future partners or investors. The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting served as a major channel for presenting interim data on petosemtamab in combination with pembrolizumab for first-line head and neck squamous cell carcinoma (HNSCC).

The data presented, which was based on a February 27, 2025 data cutoff, involved 45 patients treated, with 43 in the efficacy evaluable population. The key efficacy metrics shared through this channel were:

The clinical performance data from the ASCO 2025 presentation:

Endpoint	Result (N=43 Evaluable Patients)
Confirmed Overall Response Rate (ORR)	63% (27/43)
Median Progression-Free Survival (PFS)	9 months (95% CI: 5.2-12.9)
12-Month Overall Survival (OS) Rate	79% (30/43 censored)

The company held a conference call and webcast on May 22, 2025, at 5:30 p.m. ET to discuss the full ASCO data set.

Merus N.V. (MRUS) - Canvas Business Model: Customer Segments

You're looking at the key groups Merus N.V. serves, which are primarily defined by the clinical stage and specific biomarker of their oncology assets as of late 2025. It's a mix of big pharma money and very specific patient populations.

The largest external customer segment involves the large global pharmaceutical and biotechnology companies that partner with Merus N.V. to access their proprietary antibody platforms like Biclonics® and Triclonics®. These relationships are financially significant, as evidenced by the recent acquisition announcement.

Partner/Transaction	Date of Major Update/Agreement	Financial Implication/Status
Genmab A/S (Acquisition)	September/November 2025	Transaction value approximately $8.0 billion in an all-cash deal.
Biohaven Ltd.	January 2025	Collaboration to co-develop three novel bispecific ADC programs; Merus receives upfront payment and license fee at ADC candidate nomination.
Gilead Sciences	March 2024	Upfront payment of $56 million plus $25 million equity investment for two to three preclinical research programs.
Eli Lilly and Company	January 2021	Agreement for up to three CD3-engaging T-cell re-directing bispecific antibody therapies.

Merus N.V.'s internal financial health, which supports engaging these partners, shows a strong balance sheet as of mid-2025. Cash, cash equivalents, and marketable securities were $892 million as of June 30, 2025, expected to fund operations at least into 2028. Collaboration revenue for the three months ended March 31, 2025, increased by $18.6 million compared to the same period in 2024.

The primary patient segments are defined by the indications for their lead candidates, petosemtamab and Bizengri® (zenocutuzumab).

For petosemtamab (EGFR x LGR5 Biclonics®), the focus is on oncology patients with solid tumors, specifically Head and Neck Squamous Cell Carcinoma (HNSCC). Merus N.V. has two Phase 3 trials enrolling, LiGeR-HN1 (1L r/m HNSCC) and LiGeR-HN2 (2/3L r/m HNSCC), both expected to be substantially enrolled by year-end 2025.

• 1L PD-L1+ r/m HNSCC Phase 2 data (combination with pembrolizumab, data cutoff Feb 27, 2025): 43 evaluable patients showed a 63% response rate and a 79% overall survival rate at 12-months.
• 2L+ r/m HNSCC monotherapy Phase 2 data (ESMO Asia Congress): 36% response rate among 75 evaluable patients.
• The Phase 2 HNSCC trial enrolled 45 patients with a median age of 64 years (range 23-80).

The second critical patient group is patients with rare cancers like NRG1 fusion-positive pancreatic or lung cancer, treated with Bizengri® (zenocutuzumab). This drug received FDA approval for advanced unresectable or metastatic NRG1+ pancreatic adenocarcinoma or NSCLC.

• The eNRGy study reviewed results from 204 patients with 12 tumor types.
• Specifically, the trial included 30 patients with NRG1+ pancreatic adenocarcinoma and 64 patients with NRG1+ NSCLC.
• Across a retrospective analysis of 25,203 solid tumor patients, the overall frequency of NRG1 fusions was 0.2% (49 patients).
• In lung cancer patients from that analysis, the frequency was 0.29% (36 fusions out of 12,458 patients).

The final segment, oncologists and clinical investigators participating in trials, are essential for generating the data that supports the value proposition. The clinical trial support expense for Merus N.V. in Q1 2025 increased by $35.6 million compared to Q1 2024, largely related to petosemtamab trials.

Merus N.V. (MRUS) - Canvas Business Model: Cost Structure

The cost structure for Merus N.V. is heavily weighted toward the front end of drug development, which is typical for a clinical-stage immuno-oncology company. You see this capital intensity reflected in the massive operating losses required to advance their pipeline, such as the $95.52 million net loss reported for the third quarter ended September 30, 2025.

Dominant Research and Development (R&D) expenses, totaling $0.328 billion for the twelve months trailing (TTM) ending September 30, 2025, represent the single largest outflow of capital. This figure reflects a 71.42% year-over-year increase, showing the acceleration of late-stage trial activity.

High costs for clinical trial support, including CROs (Contract Research Organizations) and contract manufacturing, are the primary driver behind the R&D surge. For instance, the R&D expense for the six months ended June 30, 2025, saw an increase of $86.3 million year-over-year, with $73.7 million of that increase specifically tied to clinical trial support from contract manufacturing and development organizations and CROs, mostly related to the petosemtamab clinical trials. Similarly, the Q2 2025 R&D increase of $44.8 million included $37.9 million attributed to these external clinical service providers.

Significant General and Administrative (G&A) expenses are also a major component, primarily driven by personnel costs. For the three months ended March 31, 2025, G&A expenses rose by $6.0 million compared to the prior year, with personnel related expenses, including share-based compensation, accounting for $5.3 million of that increase. Legal fees also contribute to this overhead; for the three months ended June 30, 2025, legal expenses were up by $0.6 million year-over-year as part of the overall G&A increase of $2.7 million.

Intellectual property maintenance and patent prosecution costs are necessary expenditures to protect the proprietary Biclonics® platform and pipeline assets. While these costs fluctuate, they are a persistent part of the G&A structure. For example, in the second quarter of 2025, there was a decrease in intellectual property and license expenses of $0.3 million offsetting other G&A increases.

Here's a quick look at how some of these key expense drivers compared in recent periods:

Expense Category	Period Ending	Reported Amount (USD)
Total Research and Development Expense (TTM)	September 30, 2025	$328 million
Increase in Clinical Trial Support (6M)	June 30, 2025	$73.7 million
Total General and Administrative Expense (Q1 2025)	March 31, 2025	$22.1 million
Personnel/Share-Based Comp Impact on G&A (Q1 2025)	Three Months Ended March 31, 2025	$5.3 million
Net Loss (Q3 2025)	September 30, 2025	$95.52 million

You can see the R&D burn is the main event, but the operational overhead is also climbing as the company scales its team and legal/administrative footprint to support global trials. The cost structure is fundamentally about funding the clinical advancement of petosemtamab.

• R&D expenses are the dominant cost driver.
• Clinical trial support from CROs/CMOs is the largest R&D sub-component.
• Personnel costs, including share-based compensation, drive G&A increases.
• Legal fees and IP maintenance are ongoing administrative costs.

Finance: draft 13-week cash view by Friday.

Merus N.V. (MRUS) - Canvas Business Model: Revenue Streams

You're looking at the top-line figures for Merus N.V. (MRUS) as of late 2025, focusing on where the money actually comes from. It's heavily weighted toward partnerships, which is typical for a clinical-stage biotech.

Collaboration revenue is the bedrock here, stemming from upfront payments, milestone achievements, and research funding reimbursements under existing agreements. For the three months ended March 31, 2025, collaboration revenue saw a significant jump, increasing by $18.6 million compared to the same period in 2024. This increase was partly attributed to higher deferred revenue amortization during that quarter.

A key component of the recent revenue recognition is the commercial material revenue tied to the BIZENGRI® partnership with Partner Therapeutics (PTx). You saw $13.3 million recognized specifically from commercial material revenue in the first quarter of 2025. This same figure of $13.3 million was reported as commercial material revenue sold to PTx for the six months ended June 30, 2025.

Deferred revenue amortization reflects the recognition of those upfront payments received in prior years from partners like Gilead and Incyte. As of June 30, 2025, Merus N.V. reported total deferred revenue of $64.5 million. This balance is spread across agreements, with $53.9 million primarily related to the Gilead collaboration agreement and $10.6 million from the Incyte agreement. The amortization schedule for these is based on progress toward development milestones for the respective programs. For example, the Gilead revenue increase for the six months ended June 30, 2025, was driven by upfront payment amortization of $0.1 million.

Overall, the top line shows significant growth driven by these non-product sales revenue sources. Total revenue for the nine months ended September 30, 2025, reached $47.47 million. This compares to $26.99 million for the same nine-month period in 2024.

Here's a quick look at the reported revenue components near the reporting date:

• Total revenue (Nine Months Ended September 30, 2025): $47.47 million.
• Revenue (Q3 2025): $12.15 million.
• Commercial Material Revenue (Q1 2025): $13.3 million.
• Cash, cash equivalents, and marketable securities (March 31, 2025): $638 million.

The structure of this revenue stream is best seen by breaking down the known components that contribute to the overall collaboration revenue:

Revenue Component	Period	Amount (USD)
Total Revenue	Nine Months Ended September 30, 2025	$47.47 million
Commercial Material Revenue (PTx)	Three Months Ended March 31, 2025	$13.3 million
Collaboration Revenue Increase vs. Prior Year	Three Months Ended March 31, 2025	$18.6 million
Total Deferred Revenue Balance	As of June 30, 2025	$64.5 million

Finance: draft 13-week cash view by Friday.