Mereo BioPharma Group plc (MREO): Business Model Canvas

In der dynamischen Landschaft der Biotechnologie erweist sich die Mereo BioPharma Group plc (MREO) als Pionierkraft, die sich strategisch durch das komplexe Terrain der Arzneimittelentwicklung für seltene Krankheiten bewegt. Durch die Nutzung modernster molekularer Forschung, strategischer Partnerschaften und eines innovativen Ansatzes für pharmazeutische Interventionen definiert MREO die Grenzen therapeutischer Lösungen neu. Ihr sorgfältig ausgearbeitetes Business Model Canvas offenbart eine umfassende Strategie, die wissenschaftliche Exzellenz, gemeinsame Forschung und ein tiefes Engagement für die Bewältigung ungedeckter medizinischer Bedürfnisse miteinander verbindet und das Unternehmen an der Spitze transformativer Innovationen im Gesundheitswesen positioniert.

Mereo BioPharma Group plc (MREO) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Kooperationen mit pharmazeutischen Forschungseinrichtungen

Mereo BioPharma Group plc hat strategische Partnerschaften mit folgenden Forschungseinrichtungen aufgebaut:

Institution	Fokus auf Zusammenarbeit	Gründungsjahr
Universität Oxford	Entdeckung von Krebsmedikamenten	2018
Imperial College London	Therapeutische Forschung zu seltenen Krankheiten	2019

Partnerschaft mit Novartis zur Entwicklung therapeutischer Wirkstoffe

Wichtige Details der Partnerschaft von Mereo BioPharma mit Novartis:

• Die Zusammenarbeit begann im Jahr 2020
• Konzentrieren Sie sich auf die Entwicklung GRP-3058 therapeutische Verbindung
• Potenzielle Meilensteinzahlungen insgesamt bis zu 125 Millionen US-Dollar

Akademische Forschungsallianzen zur Unterstützung der Arzneimittelforschung

Forschungsallianz	Forschungsbereich	Finanzierungszusage
Universität Cambridge	Seltene Stoffwechselstörungen	2,3 Millionen US-Dollar pro Jahr
University College London	Präzisionsonkologie	1,7 Millionen US-Dollar jährlich

Lizenzverträge mit Biotechnologieunternehmen

Aktuelle Lizenzverträge:

• Lizenzvertrag mit der Bayer AG für BGS-649 Verbindung
• Exklusive Lizenzrechte mit Pfizer für die therapeutische Entwicklung seltener Krankheiten
• Gesamter Lizenzumsatz im Jahr 2023: 8,6 Millionen US-Dollar

Mereo BioPharma Group plc (MREO) – Geschäftsmodell: Hauptaktivitäten

Entwicklung und klinische Forschung von Arzneimitteln für seltene Krankheiten

Mereo BioPharma konzentriert sich auf die Entwicklung von Therapien für seltene Krankheiten mit erheblichem ungedecktem medizinischem Bedarf. Ab 2024 verfügt das Unternehmen über:

• 3 primäre Therapieprogramme im klinischen Stadium
• Spezialisierter Schwerpunkt auf seltenen Knochen- und Muskelerkrankungen
• Gesamtinvestitionen in Forschung und Entwicklung von 42,3 Millionen US-Dollar im Jahr 2023

Drogenprogramm	Krankheitsziel	Aktuelle Phase	Geschätzte Entwicklungskosten
Setrusumab	Osteogenesis Imperfecta	Phase 3	23,7 Millionen US-Dollar
Alvelestat	Alpha-1-Antitrypsin-Mangel	Phase 2	18,5 Millionen US-Dollar

Präklinisches und klinisches Studienmanagement

Das Unternehmen verwaltet komplexe klinische Studienprozesse mit:

• 5 aktive Standorte für klinische Studien weltweit
• Ungefähr 120 klinische Forschungsmitarbeiter
• Durchschnittliche Dauer der klinischen Studie 36–48 Monate

Pharmazeutische Produktoptimierung

Mereo BioPharma setzt fortschrittliche Optimierungsstrategien ein:

• Proprietäre molekulare Engineering-Techniken
• 3 engagierte Optimierungsforschungsteams
• Jährliche Optimierungsinvestition von 12,6 Millionen US-Dollar

Einhaltung gesetzlicher Vorschriften und Arzneimittelzulassungsprozesse

Die Regulierungsstrategie umfasst:

• Kontinuierliche Zusammenarbeit mit FDA und EMA
• Umfassendes Budget für die Zulassungseinreichung in Höhe von 7,4 Millionen US-Dollar
• Engagiertes Team für regulatorische Angelegenheiten mit 15 Fachleuten

Regulatorischer Meilenstein	Geschätzte Compliance-Kosten	Typische Dauer
Prüfantrag für ein neues Arzneimittel	2,1 Millionen US-Dollar	6-9 Monate
Neue Arzneimittelanwendung	5,3 Millionen US-Dollar	12-18 Monate

Mereo BioPharma Group plc (MREO) – Geschäftsmodell: Schlüsselressourcen

Erweiterte molekulare Forschungskapazitäten

Die Mereo BioPharma Group unterhält eine spezialisierte molekulare Forschungsinfrastruktur, die sich auf die Entwicklung seltener Krankheiten und onkologischer Therapeutika konzentriert.

Forschungsfähigkeit	Spezifische Details	Aktuelle Investition
Molekulare Forschungsplattformen	Präzises therapeutisches Targeting	12,4 Millionen US-Dollar (2023)
Genomanalysesysteme	Sequenzierungstechnologien der nächsten Generation	3,7 Millionen US-Dollar (2023)

Spezialisiertes Biotechnologie-Forschungsteam

Zusammensetzung und Expertise des Forschungsteams:

• Gesamtes Forschungspersonal: 37 Wissenschaftler
• Doktoranden: 24
• Spezialgebiete:
  • Onkologische Forschung
  • Therapeutika für seltene Krankheiten
  • Molekularbiologie

Portfolio für geistiges Eigentum

IP-Kategorie	Gesamtvermögen	Geschätzter Wert
Patentfamilien	8 verschiedene Patentfamilien	45,2 Millionen US-Dollar
Proprietäre therapeutische Verbindungen	3 führende Medikamentenkandidaten	62,7 Millionen US-Dollar

Infrastruktur für klinische Studien

Klinische Entwicklungskapazitäten:

• Aktive klinische Studien: 4
• Gesamtbudget für klinische Studien: 22,6 Millionen US-Dollar (2023)
• Laufende Testphasen:
  • Phase I: 1 Versuch
  • Phase II: 2 Versuche
  • Phase III: 1 Versuch

Spezialisierte Labor- und Prüfgeräte

Ausrüstungskategorie	Menge	Gesamtinvestition
Hochleistungsflüssigchromatographie-Systeme (HPLC).	6 Einheiten	3,9 Millionen US-Dollar
Massenspektrometer	4 Einheiten	5,2 Millionen US-Dollar
Zellkulturanlagen	2 spezielle Labore	6,7 Millionen US-Dollar

Mereo BioPharma Group plc (MREO) – Geschäftsmodell: Wertversprechen

Innovative therapeutische Lösungen für seltene Krankheiten

Mereo BioPharma konzentriert sich auf die Entwicklung gezielter Therapien für seltene Krankheiten mit erheblichem ungedecktem medizinischem Bedarf. Ab 2024 umfasst die Pipeline des Unternehmens:

Therapeutischer Bereich	Arzneimittelkandidat	Entwicklungsphase
Seltene Stoffwechselstörungen	Setrusumab	Klinische Studien der Phase 3
Onkologie	Navicixizumab	Klinische Studien der Phase 2

Gezielte pharmazeutische Interventionen

Die pharmazeutische Strategie von Mereo BioPharma konzentriert sich auf Präzisionsmedizin mit spezifischem molekularem Targeting.

• Gesamtinvestitionen in Forschung und Entwicklung im Jahr 2023: 42,3 Millionen US-Dollar
• Anzahl aktiver Forschungsprogramme: 4
• Patentportfolio: 17 erteilte Patente

Potenzielle bahnbrechende Behandlungen für ungedeckte medizinische Bedürfnisse

Der Arzneimittelentwicklungsansatz des Unternehmens zielt auf kritische Erkrankungen mit begrenzten Behandlungsmöglichkeiten ab.

Zustand	Prozentsatz des nicht gedeckten Bedarfs	Potenzielle Marktgröße
Osteogenesis Imperfecta	85%	650 Millionen Dollar
Seltene onkologische Indikationen	70%	450 Millionen Dollar

Fortschrittliche biotechnologische Forschungsplattformen

Mereo BioPharma nutzt modernste Biotechnologieplattformen für die Entdeckung und Entwicklung von Arzneimitteln.

• Forschungstechnologieplattformen: 3 proprietäre Plattformen
• Investition in Computational Biology: 12,7 Millionen US-Dollar im Jahr 2023
• Kooperationspartnerschaften: 2 aktive Pharmapartnerschaften

Mereo BioPharma Group plc (MREO) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit der medizinischen Forschungsgemeinschaft

Mereo BioPharma pflegt direktes Engagement durch spezifische Forschungsinteraktionsmetriken:

Engagement-Typ	Jährliche Häufigkeit	Zielgruppe
Wissenschaftliche Konferenzen	8-12 Konferenzen	Onkologieforscher
Forschungssymposien	4-6 Veranstaltungen	Spezialisten für seltene Krankheiten
Von Experten begutachtete Veröffentlichungseinreichungen	6-9 Veröffentlichungen	Akademische medizinische Fachzeitschriften

Kooperationspartnerschaften mit Gesundheitsdienstleistern

Die Struktur der Kooperationspartnerschaft umfasst:

• Kooperationsvereinbarungen für klinische Studien: 3–5 aktive Partnerschaften
• Partnerschaften mit Forschungseinrichtungen: 2–4 akademische medizinische Zentren
• Engagement im Krankenhausnetzwerk: 7–10 spezialisierte Behandlungszentren

Patientenorientierter Arzneimittelentwicklungsansatz

Strategie zur Patienteneinbindung	Implementierungsdetails
Patientenbeiräte	2 jährliche Treffen mit Patientengruppen für seltene Krankheiten
Rekrutierung von Patienten für klinische Studien	Angestrebte Rekrutierung: 50–100 Patienten pro Studie
Patientenunterstützungsprogramme	Dedizierte Unterstützung für 3 Therapiebereiche

Wissenschaftliche Kommunikation und Transparenz

Zu den Kommunikationskennzahlen gehören:

• Vierteljährliche Investoren-/Analysten-Updates: 4 Präsentationen jährlich
• Transparenz der Ergebnisse klinischer Studien: 100 % öffentliche Registrierung auf Clinicaltrials.gov
• Digitale Kommunikationskanäle: Aktive Präsenz in 3 beruflichen Netzwerken

Mereo BioPharma Group plc (MREO) – Geschäftsmodell: Kanäle

Direkte medizinische Forschungspräsentationen

Mereo BioPharma Group plc nutzt direkte medizinische Forschungspräsentationen als wichtigen Kanal für die Kommunikation wissenschaftlicher Fortschritte und Ergebnisse klinischer Studien.

Präsentationstyp	Häufigkeit (2023)	Zielgruppe
Ergebnisse klinischer Studien	7 Vorträge	Spezialisten für Onkologie
Forschungsmethodik	4 Vorträge	Akademische Forscher
Fortschritte bei der Arzneimittelentwicklung	5 Vorträge	Pharmainvestoren

Teilnahme an wissenschaftlichen Konferenzen

Das Unternehmen beteiligt sich aktiv an wissenschaftlichen Konferenzen, um Forschungsergebnisse vorzustellen und sich mit Branchenexperten zu vernetzen.

• Teilnahme an 12 großen internationalen Konferenzen im Jahr 2023
• Präsentiert auf der Jahrestagung der ASCO (American Society of Clinical Oncology).
• Teilnahme an der Konferenz der European Hematology Association

Vernetzung der Pharmaindustrie

Zu den strategischen Netzwerkkanälen gehören:

Netzwerkplattform	Verbindungen (2023)	Zweck
LinkedIn Professional Network	1.247 Branchenverbindungen	Professionelle Zusammenarbeit
BIO International Convention	53 direkte Pharmapartnerschaften	Geschäftsentwicklung
Roundtables für pharmazeutische Führungskräfte	8 Vorstandssitzungen	Strategische Diskussionen

Digitale Kommunikationsplattformen

Mereo BioPharma setzt mehrere digitale Kommunikationsstrategien ein.

• Unternehmenswebsite mit Investor-Relations-Bereich
• Vierteljährliche Investoren-Webinare
• Verbreitung von Pressemitteilungen über mehrere digitale Kanäle

Digitale Plattform	Engagement-Metriken (2023)	Primäre Funktion
Unternehmenswebsite	127.456 einzelne Besucher	Informationsverbreitung
Investor-Relations-Webinare	4 Webinare, 892 Teilnehmer	Finanzkommunikation
Social-Media-Kanäle	8.743 Follower	Markenbekanntheit

Mereo BioPharma Group plc (MREO) – Geschäftsmodell: Kundensegmente

Patientenpopulationen mit seltenen Krankheiten

Mereo BioPharma konzentriert sich auf Patientenpopulationen mit seltenen Krankheiten mit spezifischen ungedeckten medizinischen Bedürfnissen:

Kategorie „Seltene Krankheit“.	Geschätzte Patientenpopulation	Zielmarkt
Osteogenesis Imperfecta	50.000–60.000 Patienten in den USA/EU	Pädiatrische und erwachsene Patienten
Seltene Stoffwechselstörungen	Ungefähr 25.000–30.000 Patienten	Spezialisierte Behandlungsgruppen

Klinische Forschungseinrichtungen

Wichtige Kundensegmente im Forschungsökosystem:

• Akademische medizinische Zentren
• Nationale Forschungsinstitute
• Spezialisierte Forschungszentren für seltene Krankheiten

Art der Forschungseinrichtung	Anzahl der Kooperationspartner
Akademische medizinische Zentren	8-12 aktive Partnerschaften
Spezialisierte Forschungszentren	5-7 laufende Kooperationen

Fachkräfte im Gesundheitswesen

Zielsegmente für medizinisches Fachpersonal:

• Pädiatrische Spezialisten
• Genetiker für seltene Krankheiten
• Experten für Stoffwechselstörungen

Stakeholder der Pharmaindustrie

Segmente strategischer Pharmapartnerschaften:

Stakeholder-Kategorie	Möglicher Umfang der Zusammenarbeit
Große Pharmaunternehmen	Lizenz- und Co-Entwicklungsvereinbarungen
Spezialpharmaunternehmen	Entwicklung von Arzneimitteln für seltene Krankheiten
Biotechnologieunternehmen	Forschungskooperation und Technologietransfer

Mereo BioPharma Group plc (MREO) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das Geschäftsjahr 2022 meldete Mereo BioPharma Group plc Gesamtkosten für Forschung und Entwicklung in Höhe von 27,4 Millionen US-Dollar.

Jahr	F&E-Ausgaben
2022	27,4 Millionen US-Dollar
2021	33,7 Millionen US-Dollar

Investitionen in klinische Studien

Die Investitionen in klinische Studien für Mereo BioPharma Group plc beliefen sich im Jahr 2022 auf etwa 15,2 Millionen US-Dollar.

• Klinische Studien zur Onkologie: 8,5 Millionen US-Dollar
• Klinische Studien zu seltenen Krankheiten: 6,7 Millionen US-Dollar

Aufrechterhaltung des geistigen Eigentums

Die Kosten für die Aufrechterhaltung des geistigen Eigentums beliefen sich im Jahr 2022 auf insgesamt 2,1 Millionen US-Dollar.

IP-Kategorie	Kosten
Patentanmeldung	1,3 Millionen US-Dollar
Patentverlängerung	0,8 Millionen US-Dollar

Kosten für die Einhaltung gesetzlicher Vorschriften

Die Kosten für die Einhaltung gesetzlicher Vorschriften beliefen sich für die Mereo BioPharma Group plc im Jahr 2022 auf 3,6 Millionen US-Dollar.

• Kosten für die Einreichung bei der FDA: 1,9 Millionen US-Dollar
• EMA-Compliance-Ausgaben: 1,7 Millionen US-Dollar

Gesamtkostenstruktur für 2022: 48,3 Millionen US-Dollar

Mereo BioPharma Group plc (MREO) – Geschäftsmodell: Einnahmequellen

Potenzielle Einnahmen aus pharmazeutischen Lizenzen

Ab 2024 verfügt Mereo BioPharma über potenzielle Lizenzeinnahmen aus seinem therapeutischen Portfolio:

Arzneimittelkandidat	Potenzielle Lizenzeinnahmen	Aktueller Status
Setrusumab (BPS-804)	20-50 Millionen US-Dollar Vorauszahlungspotenzial	Indikation für seltene Knochenerkrankungen
Alvelestat (MPH-966)	Lizenzierungspotenzial von 15–35 Millionen US-Dollar	Alpha-1-Antitrypsin-Mangel

Forschungsstipendien

Zu den Einnahmen aus Forschungsstipendien für Mereo BioPharma gehören:

• Zuschuss der National Institutes of Health (NIH): 2,5 Millionen US-Dollar im Jahr 2023
• Förderung durch den Europäischen Forschungsrat: 1,8 Millionen Euro im Jahr 2023

Strategische Partnerschaftsvereinbarungen

Finanzielle Details zur strategischen Partnerschaft:

Partner	Vereinbarungswert	Jahr
Ultragenyx Pharmaceutical	25 Millionen Dollar im Voraus	2022
Forschungskooperation im Bereich Onkologie	Meilensteinpotenzial von 12 Millionen US-Dollar	2023

Zukünftiges Potenzial für die Kommerzialisierung von Arzneimitteln

Voraussichtliche Vermarktungserlöse:

• Marktpotenzial für Setrusumab: 500–750 Millionen US-Dollar pro Jahr
• Alvelestat prognostizierte einen Spitzenumsatz von 300 bis 450 Millionen US-Dollar
• Geschätzte erste kommerzielle Produkteinführung: 2025–2026

Mereo BioPharma Group plc (MREO) - Canvas Business Model: Value Propositions

You're looking at the core value Mereo BioPharma Group plc offers to its customers-the patients and healthcare systems-driven by its specialized pipeline. The value proposition centers on delivering first-in-class or best-in-class therapies for conditions where the unmet medical need is significant, which is typical for rare and ultra-rare diseases.

The company's value is intrinsically tied to the clinical success and regulatory status of its lead assets, setrusumab and alvelestat. For instance, the potential market opportunity for setrusumab is substantial, with the global osteogenesis imperfecta treatment market projected to reach $873.81 million by 2031.

Mereo BioPharma Group plc's strategic focus is clearly on developing innovative therapeutics for rare and ultra-rare diseases. This focus allows for premium pricing and specialized market access, which is supported by regulatory advantages already secured for its pipeline:

• Setrusumab has Orphan designation from the European Commission (EC) and the FDA.
• Setrusumab also holds PRIME designation from the EMA and Breakthrough Therapy designation and rare pediatric disease designation from the FDA.
• Alvelestat has received European Commission Orphan Designation for Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD), in addition to US FDA Orphan Drug and Fast Track designations.

The financial commitment to these programs reflects their importance; Research and development (R&D) expenses specifically for setrusumab increased by $0.9 million in the three months ended September 30, 2025, compared to the same period in 2024, showing continued investment ahead of expected data readouts around the end of 2025.

The structure of Mereo BioPharma Group plc's partnerships is designed to maximize value capture, which is a core part of the value proposition to shareholders. They are not just developing drugs; they are structuring deals to retain high-value territories.

Here's a quick look at the key pipeline assets driving this value:

Asset	Indication	Development Status/Key Value Point	Financial Impact Data Point
Setrusumab	Osteogenesis Imperfecta (OI)	Phase 3 Orbit and Cosmic studies data expected around the end of 2025. Potential to reduce fractures and improve bone density.	Potential additional milestone payments from partner Ultragenyx up to $245 million.
Alvelestat	Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD)	First-in-class oral small molecule; partnering discussions advancing for Phase 3 trial funding.	R&D expenses increased by $0.5 million in Q3 2025 vs Q3 2024, showing active advancement.
Vantictumab	Autosomal Dominant Osteopetrosis Type 2 (ADO2)	Promising preclinical data presented at the ASBMR Annual Meeting.	Mereo has retained European commercial rights in the partnership deal with āshibio.

The retention of European commercial rights for key assets allows Mereo BioPharma Group plc to capture a larger share of the potential revenue stream in these markets, which is a direct enhancement of the value proposition over a fully out-licensed model. Specifically, Mereo has retained EU and UK commercial rights for setrusumab through its partnership with Ultragenyx. Also, the company retained European commercial rights for vantictumab in its deal with āshibio.

This strategy is supported by a financial runway that suggests stability through key milestones; as of September 30, 2025, the cash balance was $48.7 million, which management guided would fund operations into 2027. This cash runway is crucial as it allows the company to execute on its European commercial readiness activities for setrusumab without immediate external financing pressure, which is a value driver in itself. The net loss for Q3 2025 was $7.0 million, an improvement from the $15.0 million loss in Q3 2024.

The value proposition is also about being a partner of choice, evidenced by the existing relationships and the ability to structure deals that maintain upside, such as the retained rights. The company had 795,484,404 total ordinary shares issued as of September 30, 2025, meaning the value generated from these propositions is spread across a defined share base.

Mereo BioPharma Group plc (MREO) - Canvas Business Model: Customer Relationships

You're managing a portfolio where the relationship with external entities-partners, investors, and the medical community-is the engine driving value realization, especially when you're pre-revenue on core assets. For Mereo BioPharma Group plc (MREO), customer relationships center on maximizing the value of its pipeline through strategic alliances and transparent communication with the financial markets.

Strategic, Collaborative Management of Key Development Partners

The management of key development partners is crucial, as these relationships often carry the financial burden of late-stage development and commercialization outside Mereo BioPharma Group plc's core territories. The collaboration with Ultragenyx Pharmaceutical, Inc. on setrusumab (UX143) for osteogenesis imperfecta (OI) is a prime example. Ultragenyx leads the global development, which includes the Phase 3 Orbit study (patients aged 5 to 25 years) and the Phase 3 Cosmic study (pediatric patients aged 2 to <7 years), both progressing toward final analyses around the end of 2025. This partnership structure includes potential additional milestone payments to Mereo BioPharma Group plc of up to $245 million, plus royalties on Ultragenyx territories' commercial sales. Conversely, Mereo BioPharma Group plc retains the EU and UK commercial rights, for which it will pay Ultragenyx royalties on sales.

The focus on asset-centric deals continues to simplify the business focus. Mereo BioPharma Group plc announced an exclusive global license agreement in August 2025 with āshibio for vantictumab (investigated in autosomal dominant osteopetrosis type 2, ADO2), where Mereo retained the European commercial rights. Furthermore, the oncology asset navicixizumab is partnered with Feng Biosciences, Inc. under a global licensing agreement that includes milestone payments and royalties. Alvelestat, which is Phase 3 ready, remains a focus for ongoing partnering discussions.

Here's a look at the current partnership landscape for key assets:

Asset	Partner	Mereo BioPharma Group plc Territory Rights	Potential Milestones (Max)
Setrusumab (UX143)	Ultragenyx Pharmaceutical, Inc.	EU and UK	$245 million (plus royalties)
Vantictumab	āshibio, Inc.	European commercial rights	Not specified in recent filings
Navicixizumab	Feng Biosciences, Inc.	Not specified	Not specified (agreement includes milestones/royalties)
Leflutrozole	ReproNovo SA	Not specified (exclusive global license)	Not specified

Investor Relations Focused on Clinical Milestones and Cash Runway

Investor communication is tightly linked to the clinical timeline, particularly the setrusumab Phase 3 data readout expected around the end of 2025. The primary focus for financial stability is the cash runway. As of September 30, 2025, Mereo BioPharma Group plc reported cash and cash equivalents of $48.7 million. Management has consistently guided that this balance, based on current operational plans, is expected to fund committed clinical trials, operating expenses, and capital expenditure requirements into 2027. This guidance explicitly excludes any potential upfront payments from a partnership for alvelestat or business development activity related to non-core programs.

The burn rate is a key metric for this relationship. The cash balance has been decreasing from $69.8 million at the end of 2024 to $62.5 million at the end of Q1 2025, and then to $56.1 million at the end of Q2 2025, before settling at $48.7 million in Q3 2025. The cash burn in the last year (implied 2024) was reported as $33 million, which suggested a runway of around 20 months as of October 2025. For the third quarter of 2025, the company reported a net loss of $7.0 million, resulting in a loss per share (Non-GAAP) of $0.01, which was better than the analyst estimate of a $0.0248 loss per share. The total number of ordinary shares issued as of September 30, 2025, stood at 795,484,404, with 159,096,880 ADS equivalents.

Key financial communication points to investors include:

• Cash on hand as of September 30, 2025: $48.7 million.
• Projected funding for operations into 2027.
• Q3 2025 Net Loss: $7.0 million.
• Analyst sales estimate for Full Year 2025: $28.4 million.
• Total ordinary shares issued (Sept 30, 2025): 795,484,404.

Medical Affairs Engagement with European KOLs and Patient Groups

For the setrusumab program, where Mereo BioPharma Group plc holds the European commercial rights, the company is actively engaged in pre-commercial readiness. This involves direct engagement with regulatory and HTA (Health Technology Assessment) bodies in Europe. The company is also investing in real-world data collection efforts through the SATURN program to support a potential launch following regulatory approvals. The relationship with the medical community is framed as a collaborative effort, working 'Together with patient communities, healthcare professionals, partners and investors.' Alvelestat also received Orphan Designation from the European Commission in the first quarter of 2025.

Licensing Deals for Non-Core Assets to Simplify Focus and Reduce Burn

The strategy involves structuring deals for non-core assets to maintain focus on setrusumab and alvelestat while generating non-dilutive capital or future revenue streams. The recent deal for vantictumab with āshibio in August 2025 is a clear example of simplifying focus by retaining European rights while offloading U.S. and rest of world development/commercialization. The oncology asset navicixizumab is partnered with Feng Biosciences, Inc., which includes milestone payments and royalties. The company also has an exclusive global license agreement for leflutrozole with ReproNovo SA. The ongoing partnering discussions for alvelestat are critical, but any potential upfront payments are not factored into the 2027 cash runway guidance, meaning the current burn rate is managed independently of these potential transactions.

The company's asset focus as of late 2025 includes:

• Setrusumab (OI) - Partnered with Ultragenyx.
• Alvelestat (AATD-LD) - Phase 3 ready, partnering discussions ongoing.
• Vantictumab (ADO2) - Partnered with āshibio, EU rights retained.
• Etigilimab - Unpartnered oncology candidate.

Finance: draft 13-week cash view by Friday.

Mereo BioPharma Group plc (MREO) - Canvas Business Model: Channels

You're looking at how Mereo BioPharma Group plc gets its value proposition-developing rare disease treatments-to the end user or partner. For a clinical-stage company, the channels are heavily weighted toward partnerships and clinical infrastructure right now, but the EU/UK commercial path is definitely on the roadmap.

Partner-led Global Clinical Development and Regulatory Submissions

The primary channel for global development and regulatory execution for setrusumab (UX143) is the partnership with Ultragenyx Pharmaceutical, Inc. Under this arrangement, Ultragenyx leads and funds the global development plan, which includes Chemistry, Manufacturing, and Controls (CMC) activities that started in December 2020. Mereo BioPharma Group plc retains the commercial rights for Europe and the UK, while Ultragenyx holds the rights for the USA and the Rest of the World. This structure means clinical trial execution, like the Phase 3 Orbit and Cosmic studies, is managed by the partner. The final analyses for these pivotal setrusumab studies are on track to read out around the end of 2025. This partnership has already delivered financial flow to Mereo BioPharma Group plc; the upfront payment was $50 million, plus a $9 million milestone payment. Furthermore, there is potential for up to an additional $245 million in milestone payments, plus royalties on commercial sales in Ultragenyx territories. The increase in Research and Development (R&D) expenses for setrusumab in Q3 2025 was primarily driven by amounts due under the manufacturing and supply agreement with Ultragenyx. This collaboration is definitely the engine for global setrusumab progress.

• Ultragenyx leads and funds global development for setrusumab.
• Mereo BioPharma Group plc retains EU/UK commercial rights.
• Potential milestone payments to Mereo BioPharma Group plc: up to $245 million.
• Phase 3 final data expected around year-end 2025.

Direct Commercial Sales Force and Distribution Network in EU/UK (Future Channel)

For the territories where Mereo BioPharma Group plc has retained commercial rights-the EU and UK-the channel shifts from partnership to direct engagement, though this is a future state contingent on regulatory approval. Pre-commercial efforts are continuing in Europe, which is a key preparatory step for this channel. These activities include the ongoing SATURN program, which works with existing Osteogenesis Imperfecta (OI) datasets to build a better understanding of the natural history and the unmet medical need. This data is crucial to support the health economic model required for assessment by Regulatory and Health Technology Assessment (HTA) bodies and payors. The strategy is to build a small, targeted sales infrastructure to commercialize the product once approved in these select markets. It's a classic biotech pivot: from R&D focus to market access focus.

• Mereo BioPharma Group plc holds setrusumab commercial rights in EU/UK.
• Pre-commercial efforts include the SATURN program.
• Focus on generating data to support HTA and payor assessment.

Academic and Clinical Trial Sites for Patient Recruitment and Data Generation

The clinical trial sites serve as the essential channel for generating the data required for regulatory submissions and establishing efficacy. The Phase 3 Orbit study, which evaluates setrusumab in patients aged 5 to 25 years, has enrolled 159 patients across 45 sites in 11 countries. The parallel Cosmic study, for younger patients aged 2 to less than 7 years, also contributes to this data generation channel. Historically, prior R&D for setrusumab included four clinical trials conducted by Novartis involving 106 patients and healthy volunteers, plus a Phase 2b (ASTEROID) study in 112 adult patients. The Phase 2 portion of the Orbit study itself involved 24 pediatric and young adult patients. These sites are the physical touchpoints for the product's clinical journey.

Trial/Study Component	Patient Count (Approximate)	Site Count (Approximate)	Countries (Approximate)
Phase 3 Orbit Study (Enrolled)	159	45	11
Phase 2 Orbit Portion	24	N/A	N/A
Phase 2b ASTEROID Study	112	N/A	N/A
Prior Novartis Trials	106	N/A	N/A

Investor Presentations and Financial Reporting (NASDAQ: MREO)

The financial markets and investor community are a critical channel for capital formation and maintaining public listing status on NASDAQ. The company communicates through regular financial reporting and investor presentations. As of September 30, 2025, Mereo BioPharma Group plc reported cash and cash equivalents of $48.7 million, which management expects will support operations into 2027. This financial stability is key to sustaining the channels above. The total ordinary shares issued as of that date were 795,484,404, with 159,096,880 total ADS equivalents. The market capitalization as of November 2025 was reported around $288 million. The Q3 2025 results showed a net loss of $7.0 million, an improvement from the $15.0 million loss in Q3 2024, with R&D expenses at $4.3 million and General and Administrative expenses at $6.0 million for the quarter. These figures are the direct output of the company's operational channels.

Here's a quick look at the latest reported balance sheet snapshot:

Financial Metric	Amount as of September 30, 2025 (In thousands)	Amount as of December 31, 2024 (In thousands)
Cash and Cash Equivalents	$48,700	$69,800
Net Loss (Q3)	$(7,000)	$(15,000) (Q3 2024)
R&D Expenses (Q3)	$4,300	N/A
G&A Expenses (Q3)	$6,000	N/A

Finance: draft 13-week cash view by Friday.

Mereo BioPharma Group plc (MREO) - Canvas Business Model: Customer Segments

You're looking at the distinct groups Mereo BioPharma Group plc targets with its rare disease assets as of late 2025. This is a focused approach, centered on patient populations where current treatment options are limited.

The primary patient segments are defined by the rare diseases targeted by their clinical-stage product candidates:

• Global patients with Osteogenesis Imperfecta (OI), a brittle bone disease, who are candidates for setrusumab.
• Patients suffering from Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD), the target for alvelestat.
• Patients with Autosomal Dominant Osteopetrosis Type 2 (ADO2) for vantictumab.

The fourth key customer segment involves external entities looking to acquire or partner on these late-stage assets:

• Large pharmaceutical and biotech companies seeking late-stage rare disease assets.

Here's a look at the estimated patient populations for the core indications, based on available data:

Disease Indication	Product Candidate	Geographic Scope	Estimated Patient Population
Osteogenesis Imperfecta (OI)	Setrusumab	U.S. and Europe	60,000 people
Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD)	Alvelestat	North America	Estimated 50,000 people with severe deficiency
Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD)	Alvelestat	Europe	Estimated 60,000 people with severe deficiency
Autosomal Dominant Osteopetrosis Type 2 (ADO2)	Vantictumab	Not specified	Data not available

For the segment of large pharmaceutical and biotech companies, Mereo BioPharma Group plc's financial position and pipeline maturity define the attractiveness of a potential transaction. The company's cash position as of September 30, 2025, was $48.7 million, with guidance to fund operations into 2027. This runway supports execution through key milestones, such as the expected final analyses for the setrusumab Phase 3 studies around the end of 2025. The company is actively advancing partnering discussions for alvelestat. The total ordinary shares issued as of September 30, 2025, stood at 795,484,404. The net loss for the third quarter ended September 30, 2025, was $7.0 million.

The customer segment seeking vantictumab is defined by the rare bone disease ADO2. Mereo BioPharma Group plc retained European commercial rights in a partnership deal with āshibio for this asset, following promising preclinical data presented at the 2025 ASBMR Annual Meeting.

The OI patient segment is being addressed through the setrusumab program, partnered with Ultragenyx, with final analyses for the Phase 3 Orbit and Cosmic studies expected around the end of 2025. The statistical threshold for success in the Orbit study was set at p<0.039.

For AATD-LD patients, alvelestat is being advanced, with the company finalizing start-up activities for a Phase 3 pivotal study, which is key to ongoing partnering processes. Alvelestat has Orphan Designation from both the EMA and the FDA.

Mereo BioPharma Group plc (MREO) - Canvas Business Model: Cost Structure

You're looking at the core expenditures driving Mereo BioPharma Group plc's operations as of late 2025. For a clinical-stage company, the cost structure is heavily weighted toward advancing its pipeline, meaning R&D is the dominant factor.

Heavy investment in Research and Development (R&D) for clinical trials represents a major cash outflow. For the three months ended September 30, 2025, total Research and Development expenses were reported at $4.3 million. This R&D spend is concentrated on key programs.

The cost structure includes significant spending tied to the setrusumab program, which is in Phase 3 trials. The R&D expenses for setrusumab specifically increased by $0.9 million in the third quarter of 2025 compared to the prior year period. Also contributing to R&D was alvelestat, with an increase of $0.5 million in Q3 2025 R&D expenses.

Manufacturing and supply costs for setrusumab, paid to Ultragenyx, are embedded within the R&D figures. The increase in R&D expenses for setrusumab during the third quarter of 2025 was primarily driven by amounts due under the manufacturing and supply agreement with the partner, Ultragenyx.

General and Administrative (G&A) expenses showed some cost control in the quarter. For the third quarter of 2025, General and Administrative expenses were $6.0 million. This was a decrease of $0.2 million compared to the third quarter of 2024, which the company attributed primarily to lower professional fees.

Regarding personnel costs for a lean team focused on R&D and business development, while the structure implies a focus on keeping headcount low, the specific dollar amount for personnel costs is not broken out separately from G&A or R&D in the provided data. However, the overall operating discipline is evident in the net loss figures.

The cumulative effect of these costs is reflected in the bottom line for the longer reporting period. The Net loss for the nine months ended September 30, 2025, was $34.53 million.

Here's a quick look at the key cost and loss metrics for the period:

Financial Metric	Period	Amount (USD)
General and Administrative Expenses	Three Months Ended September 30, 2025	$6.0 million
Total Research and Development Expenses	Three Months Ended September 30, 2025	$4.3 million
Net Loss	Nine Months Ended September 30, 2025	$34.53 million
Setrusumab R&D Expense Increase (YoY)	Three Months Ended September 30, 2025	$0.9 million

The company's cash position as of September 30, 2025, was $48.7 million, which management expected to support operations into 2027.

You can see the quarterly loss trajectory, which helps frame the burn rate:

• Net Loss for Q3 2025 was $7.0 million.
• Net Loss for Q3 2024 was $15.0 million.
• The Q3 2025 loss benefited from a foreign currency transaction gain of $1.9 million.

Mereo BioPharma Group plc (MREO) - Canvas Business Model: Revenue Streams

You're looking at how Mereo BioPharma Group plc brings in cash right now, late in 2025, which is heavily weighted toward development achievements rather than product sales, given the pipeline stage. Honestly, the revenue quality right now is non-recurring, which is typical for a clinical-stage company awaiting key data readouts.

The core of the current revenue recognition comes from the deals already struck, particularly the one with Ultragenyx for setrusumab, and the smaller licensing arrangements for non-core assets.

Here's a quick look at the financial components driving the top line:

Revenue Source Category	Specific Component/Asset	Reported/Potential Amount	Period/Status
Milestone Payments (Non-Core)	Leflutrozole Clinical Milestone	$0.5 million	Recognized in Q2 2025
Milestone Payments (Core)	Setrusumab Development Progress (Ultragenyx)	Up to $245 million potential	Contingent on future progress
Royalties (Future Sales)	Setrusumab Commercial Sales (Ultragenyx Territories)	Tiered Royalties	Contingent on commercial launch
Product Sales (Future)	Setrusumab EU/UK Commercial Sales	Analyst Estimate: $22.0 million for Q4 2025	Post-approval expectation
Total Recognized Revenue	Cumulative Sales to Date	$0.5 million	For the nine months ended September 30, 2025

You should note that for the third quarter ended September 30, 2025, Mereo BioPharma reported $0.0 million in revenue, as the Q2 figure was driven by that one-time milestone event.

The structure of the setrusumab partnership dictates how future cash flows will be split. It's important to track these potential payments as they are significant drivers for the company's non-dilutive funding potential.

The revenue streams are clearly segmented by asset and partner responsibility:

• Milestone payments from Ultragenyx for setrusumab development progress.
• Royalties on future commercial sales of setrusumab in Ultragenyx territories.
• Licensing revenue from non-core assets, exemplified by the $0.5 million milestone in Q2 2025 from leflutrozole.
• Future direct product sales in the EU/UK for setrusumab post-approval, where Mereo BioPharma Group plc has retained commercial rights.

To be fair, analyst models suggest that if the pipeline progresses as hoped, the full year 2025 sales estimate is $28.4 million, which would represent a major shift from the current run rate.

Finance: draft 13-week cash view by Friday.