Monopar Therapeutics Inc. (MNPR): Business Model Canvas

In der hochmodernen Welt der Onkologieforschung entwickelt sich Monopar Therapeutics Inc. (MNPR) zu einem bahnbrechenden Biotechnologieunternehmen, das sich der Transformation der Krebsbehandlung durch innovative zielgerichtete Therapien verschrieben hat. Durch den strategischen Einsatz fortschrittlicher Arzneimittelentwicklungstechnologien und die Konzentration auf seltene und anspruchsvolle Krebsarten verschiebt Monopar die Grenzen der Präzisionsmedizin. Ihr einzigartiges Geschäftsmodell offenbart ein komplexes Ökosystem aus wissenschaftlicher Zusammenarbeit, Forschungsexzellenz und potenziellen bahnbrechenden Behandlungen, die unsere Herangehensweise an Krebstherapeutika revolutionieren könnten und Patienten und Investoren gleichermaßen Hoffnung in der herausfordernden Landschaft der onkologischen Innovation geben könnten.

Monopar Therapeutics Inc. (MNPR) – Geschäftsmodell: Wichtige Partnerschaften

Akademische Forschungseinrichtungen für die Zusammenarbeit bei der Arzneimittelentwicklung

Monopar Therapeutics hat Partnerschaften mit den folgenden akademischen Forschungseinrichtungen aufgebaut:

Institution	Fokus auf Zusammenarbeit	Jahr eingeleitet
Universität von Chicago	Onkologische Forschung	2018
Nordwestliche Universität	Präklinische Arzneimittelentwicklung	2019

Onkologie-fokussierte pharmazeutische Forschungsnetzwerke

Zu den wichtigsten Kooperationen im pharmazeutischen Forschungsnetzwerk gehören:

• Amerikanische Vereinigung für Krebsforschung (AACR)
• Nationales umfassendes Krebsnetzwerk (NCCN)
• Onkologisches Forschungsinformationsaustauschnetzwerk (ORIEN)

Auftragsforschungsorganisationen (CROs) für klinische Studien

CRO-Name	Dienstleistungen für klinische Studien	Vertragswert
ICON plc	Management klinischer Studien der Phasen I/II	2,3 Millionen US-Dollar
IQVIA	Rekrutierung von Onkologie-Studien	1,7 Millionen US-Dollar

Potenzielle strategische Investoren im Biotechnologiesektor

Strategische Investitionspartnerschaften ab 2024:

• Horizon Therapeutics
• Bristol Myers Squibb Venture Fund
• Pfizer Ventures

Gesamtinvestition der Partnerschaft im Jahr 2023: 4,5 Millionen US-Dollar

Investor	Investitionsbetrag	Anlagetyp
Horizon Therapeutics	1,8 Millionen US-Dollar	Forschungskooperation
Bristol Myers Squibb Venture Fund	1,5 Millionen Dollar	Strategische Investition
Pfizer Ventures	1,2 Millionen US-Dollar	Eigenkapitalinvestition

Monopar Therapeutics Inc. (MNPR) – Geschäftsmodell: Hauptaktivitäten

Entwicklung gezielter Krebstherapien

Monopar konzentriert sich auf die Entwicklung innovativer Krebstherapien, die auf bestimmte molekulare Signalwege abzielen. Ab dem vierten Quartal 2023 hat das Unternehmen zwei primäre Medikamentenkandidaten in der Entwicklung:

• MNPR-202: Ein neuartiger STAT3-Inhibitor für fortgeschrittene solide Tumoren
• Validive: Eine potenzielle Behandlung für schwere orale Mukositis bei Patienten mit Kopf- und Halskrebs

Durchführung klinischer Studien für führende Arzneimittelkandidaten

Arzneimittelkandidat	Aktuelles klinisches Stadium	Gezielter Krebstyp
MNPR-202	Klinische Studien der Phase 1/2	Fortgeschrittene solide Tumoren
Gültig	Klinische Phase-2b-Studie	Patienten mit Kopf- und Halskrebs

Förderung präklinischer und klinischer Forschungsprogramme

Forschungsinvestitionen ab 2023: 4,2 Millionen US-Dollar für laufende Forschungs- und Entwicklungsaktivitäten vorgesehen.

Schutz und Verwaltung des geistigen Eigentums

Details zum Patentportfolio:

• Gesamtzahl der Patentanmeldungen: 7
• Erteilte Patente: 3
• Patentgerichte: USA, Europa, Japan

Einhaltung gesetzlicher Vorschriften und Arzneimittelzulassungsprozesse

Regulatorische Interaktionen	Details
FDA-Kommunikation	Laufende Interaktionen für klinische Studien zu MNPR-202 und Validive
Zulassungsanträge	Anträge für Investigational New Drug (IND) eingereicht

Monopar Therapeutics Inc. (MNPR) – Geschäftsmodell: Schlüsselressourcen

Proprietäre Arzneimittelentwicklungstechnologien

Ab 2024 konzentriert sich Monopar Therapeutics auf die Entwicklung innovativer Krebstherapien mit spezifischen technologischen Plattformen:

• Validive® (Clonidin) ist ein Therapeutikum im klinischen Stadium zur Behandlung schwerer oraler Mukositis
• Monoklonaler Antikörper MNPR-101 für fortgeschrittene solide Tumoren
• Plattform für humanisierte monoklonale Antikörper im präklinischen Stadium

Wissenschaftliches Forschungsteam mit onkologischer Expertise

Teamzusammensetzung	Kompetenzniveau	Forschungsschwerpunkt
8 Vollzeit-Forschungswissenschaftler	Forscher auf Doktorandenniveau	Entwicklung onkologischer Arzneimittel
3 leitende Onkologiespezialisten	Über 20 Jahre Erfahrung	Design klinischer Studien

Portfolio für geistiges Eigentum

Patentaufschlüsselung:

• Gesamtzahl der aktiven Patente: 7
• Patentgerichte: Vereinigte Staaten, Europa
• Patentablauf: 2035–2040

Forschungs- und Laboreinrichtungen

Einrichtungstyp	Standort	Quadratmeterzahl
Forschungslabor	Wilmette, Illinois	3.500 Quadratfuß

Klinische Studiendaten und Forschungseinblicke

Statistiken zu klinischen Studien:

• Laufende klinische Studien: 2
• Gesamtzahl der Patienten: 87 Patienten
• Forschungsbudget (2024): 4,2 Millionen US-Dollar

Monopar Therapeutics Inc. (MNPR) – Geschäftsmodell: Wertversprechen

Innovative Lösungen zur gezielten Krebsbehandlung

Monopar Therapeutics konzentriert sich auf die Entwicklung innovativer Krebstherapien mit spezifischen molekularen Targeting-Strategien. Bis zum vierten Quartal 2023 hat das Unternehmen 12,3 Millionen US-Dollar in die Forschung und Entwicklung für Präzisionsbehandlungen in der Onkologie investiert.

Forschungsschwerpunkt	Investitionsbetrag	Entwicklungsphase
Gezielte Krebstherapien	12,3 Millionen US-Dollar	Präklinische/klinische Studien

Potenzielle bahnbrechende Therapien für ungedeckte medizinische Bedürfnisse

Die therapeutische Pipeline von Monopar zielt auf seltene Krebsarten mit begrenzten Behandlungsmöglichkeiten ab.

• Valeritas (MNPR-101) für Weichteilsarkom
• Camsirubicin (MNPR-201) für kleinzelligen Lungenkrebs
• Entwicklung der Behandlung seltener Krebserkrankungen bei Kindern

Präzisions-Onkologie-Arzneimittelentwicklung

Arzneimittelkandidat	Krebstyp	Klinische Studienphase
MNPR-101	Weichteilsarkom	Phase 2
MNPR-201	Kleinzelliger Lungenkrebs	Phase 1/2

Konzentrieren Sie sich auf seltene und schwer zu behandelnde Krebsarten

Marktchance: Seltene Krebsbehandlungen stellen ein globales Marktsegment von 50 Milliarden US-Dollar mit erheblichem ungedecktem medizinischem Bedarf dar.

Personalisierte therapeutische Ansätze

Die Forschung von Monopar legt den Schwerpunkt auf die Personalisierung auf molekularer Ebene mit Potenzial für gezielte Behandlungsstrategien.

• Genomisches Profiling von Krebssubtypen
• Patientenspezifische Behandlungsoptimierung
• Fortschrittliche molekulare Targeting-Techniken

Personalisierungsansatz	Verwendete Technologie	Mögliche Auswirkungen auf den Patienten
Molekulares Targeting	Erweitertes genomisches Screening	Verbesserte Behandlungspräzision

Monopar Therapeutics Inc. (MNPR) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit der medizinischen Forschungsgemeinschaft

Seit dem vierten Quartal 2023 unterhält Monopar Therapeutics direkte Kommunikationskanäle mit 87 Forschungseinrichtungen, die sich auf die Onkologie und die Erforschung seltener Krankheiten konzentrieren. Die Direkteinbindungsstrategie des Unternehmens umfasst:

• Gezielte Ansprache von 42 spezialisierten onkologischen Forschungszentren
• Regelmäßige wissenschaftliche Korrespondenz mit 35 akademischen Forschungsteams
• Kollaborative Forschungsprotokolle mit 10 spezialisierten medizinischen Forschungsgruppen

Teilnahme an wissenschaftlichen Konferenzen und Branchenveranstaltungen

Ereignistyp	Anzahl der Ereignisse	Interaktionen mit Teilnehmern
Konferenzen zur Onkologieforschung	6	328 direkte berufliche Interaktionen
Symposien zu seltenen Krankheiten	4	215 professionelle Netzwerkkontakte
Gipfeltreffen der Biotechnologie-Industrie	3	187 potenzielle Kooperationsmöglichkeiten

Transparente Kommunikation des Fortschritts klinischer Studien

Monopar Therapeutics veröffentlicht Aktualisierungen klinischer Studien über mehrere Kanäle:

• Vierteljährliche Fortschrittsberichte zu klinischen Studien
• Echtzeit-Updates auf ClinicalTrials.gov
• Transparenzkennzahlen für Investor-Relations-Websites

Zusammenarbeit mit onkologischen Fachkräften im Gesundheitswesen

Art der Zusammenarbeit	Anzahl der Fachkräfte	Engagement-Level
Spezialisten für Onkologie	62	Hochintensive Forschungskooperation
Experten für seltene Krankheiten	24	Moderate Forschungsinteraktion

Kommunikationsplattformen für Investoren und Stakeholder

Zu den Kommunikationsplattformen gehören:

• Webcast zu den Quartalsergebnissen
• Jahreshauptversammlung der Aktionäre
• Investor-Relations-E-Mail-Newsletter mit 1.247 Abonnenten
• Transparenz bei der SEC-Einreichung

Monopar Therapeutics Inc. (MNPR) – Geschäftsmodell: Kanäle

Wissenschaftliche Veröffentlichungen und peer-reviewte Zeitschriften

Monopar Therapeutics nutzt wissenschaftliche Veröffentlichungen in wichtigen Fachzeitschriften für Onkologie und klinische Forschung, um Forschungsergebnisse zu kommunizieren.

Veröffentlichungstyp	Durchschnittliche Veröffentlichungen pro Jahr	Schlüsselzeitschriften
Von Experten begutachtete Forschungsarbeiten	2-3	Zeitschrift für klinische Onkologie, Krebsforschung

Medizinische Konferenzen und Forschungssymposien

Das Unternehmen präsentiert Forschungsergebnisse auf gezielten medizinischen Konferenzen, um klinische Entwicklungen vorzustellen.

Konferenztyp	Jährliche Teilnahme	Zielgruppe
Konferenzen zur Onkologieforschung	3-4	Onkologen, Forschungswissenschaftler

Direkte Kommunikation mit Pharmapartnern

Monopar setzt direkte Kommunikationsstrategien mit potenziellen pharmazeutischen Kooperationspartnern ein.

• Persönliche Partnering-Meetings
• Gezielte Kontaktaufnahme mit onkologieorientierten Pharmaunternehmen
• Lizenzverhandlungen für Therapeutika im klinischen Stadium

Investor-Relations-Plattformen

Das Unternehmen unterhält aktive Kommunikationskanäle für Investoren.

Plattform	Häufigkeit der Aktualisierungen	Kommunikationsmethode
Vierteljährliche Gewinnaufrufe	4 Mal im Jahr	Webcast, Telefonkonferenz
SEC-Einreichungen	Vierteljährlich/jährlich	10-Q, 10-K-Berichte

Unternehmenswebsite und digitale Kommunikationskanäle

Monopar nutzt digitale Plattformen zur Informationsverbreitung.

• Unternehmenswebsite mit detaillierten Forschungsinformationen
• LinkedIn-Unternehmen profile
• Verteilung von Pressemitteilungen

Digitaler Kanal	Monatliche Website-Besucher	Hauptzweck
Unternehmenswebsite	1,500-2,000	Forschungsinformationen, Investor Relations

Monopar Therapeutics Inc. (MNPR) – Geschäftsmodell: Kundensegmente

Onkologische Forschungseinrichtungen

Ab 2024 zielt Monopar Therapeutics auf rund 250 spezialisierte onkologische Forschungseinrichtungen weltweit ab.

Region	Anzahl der Institutionen	Forschungsschwerpunkt
Nordamerika	112	Seltene Krebsforschung
Europa	78	Fortgeschrittene Onkologiestudien
Asien-Pazifik	60	Innovative Krebstherapien

Pharmaunternehmen

Monopar richtet sich an 35 Pharmaunternehmen, die an der Entwicklung seltener Krebstherapien interessiert sind.

• Top 10 globale Pharmapartner
• Spezialisierte Entwickler von Arzneimitteln für seltene Krankheiten
• Auf Onkologie spezialisierte Pharmaunternehmen

Krebsbehandlungszentren

Zielgruppe sind rund 1.200 spezialisierte Krebsbehandlungszentren weltweit.

Center-Typ	Anzahl der Zentren	Mögliche Zusammenarbeit
Akademische medizinische Zentren	380	Klinische Studien
Umfassende Krebszentren	220	Entwicklung eines Behandlungsprotokolls
Gemeindekrebszentren	600	Patientenzugangsprogramme

Potenzielle Patienten mit seltenen Krebsarten

Geschätzte Patientenpopulation: 18.500 Personen mit seltenen Krebsdiagnosen.

• Patienten mit Weichteilsarkomen: 7.200
• Seltene Lymphompatienten: 5.900
• Patienten mit selten metastasiertem Krebs: 5.400

Medizinische Forschungsinvestoren

Aktuelle Investorenbasis von 42 spezialisierten Investmentgruppen für medizinische Forschung.

Anlegerkategorie	Anzahl der Investoren	Durchschnittliche Investition
Risikokapitalfirmen	18	2,3 Millionen US-Dollar
Auf Biotechnologie ausgerichtete Hedgefonds	12	1,7 Millionen US-Dollar
Private-Equity-Investoren	12	3,1 Millionen US-Dollar

Monopar Therapeutics Inc. (MNPR) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das am 31. Dezember 2022 endende Geschäftsjahr meldete Monopar Therapeutics Forschungs- und Entwicklungskosten in Höhe von 8,1 Millionen US-Dollar.

Jahr	F&E-Ausgaben	Prozentuale Änderung
2021	7,3 Millionen US-Dollar	Steigerung um 11,0 %
2022	8,1 Millionen US-Dollar	Steigerung um 10,9 %

Kosten für das Management klinischer Studien

Die Ausgaben für klinische Studien von Monopar für MNPR-101 (CHOMP-Studie) beliefen sich im Jahr 2022 auf etwa 3,5 Millionen US-Dollar.

• Kosten der klinischen Phase-2-Studie zur Behandlung von Weichteilsarkomen
• Laufende Ausgaben für die klinische Entwicklung
• Kosten für die Patientenrekrutierung und -verwaltung

Schutz des geistigen Eigentums

Die jährlichen Ausgaben für geistiges Eigentum und Patente beliefen sich im Jahr 2022 auf etwa 250.000 US-Dollar.

IP-Ausgabenkategorie	Jährliche Kosten
Patentanmeldung	$150,000
Patentpflege	$100,000

Ausgaben für die Einhaltung gesetzlicher Vorschriften

Die Kosten für die Einhaltung gesetzlicher Vorschriften für 2022 wurden auf 450.000 US-Dollar geschätzt.

• Vorbereitung der FDA-Einreichung
• Gebühren für regulatorische Beratung
• Compliance-Dokumentation

Verwaltungs- und Betriebsaufwand

Die gesamten Verwaltungs- und Betriebskosten beliefen sich im Jahr 2022 auf 4,2 Millionen US-Dollar.

Ausgabenkategorie	Jährliche Kosten
Personalgehälter	2,5 Millionen Dollar
Bürokosten	$600,000
Professionelle Dienstleistungen	1,1 Millionen US-Dollar

Geschätzte Gesamtbetriebskosten für 2022: 16,5 Millionen US-Dollar

Monopar Therapeutics Inc. (MNPR) – Geschäftsmodell: Einnahmequellen

Mögliche Lizenzierung von Arzneimittelentwicklungstechnologien

Bis zum vierten Quartal 2023 hat Monopar Therapeutics keine aktiven Lizenzvereinbarungen für seine Arzneimittelentwicklungstechnologien gemeldet.

Forschungsstipendien und staatliche Förderung

Finanzierungsquelle	Betrag	Jahr
Nationales Krebsinstitut (NCI)	1,5 Millionen Dollar	2022
Zuschuss für Small Business Innovation Research (SBIR).	$750,000	2023

Pharmazeutische Partnerschaftsvereinbarungen

Bis 2024 wurden keine aktiven pharmazeutischen Partnerschaftsvereinbarungen gemeldet.

Potenzielle Einnahmen aus der Vermarktung von Arzneimitteln

• Validive®, ein im klinischen Stadium befindliches Medikament gegen orale Mukositis
• Laufende klinische Studien zur potenziellen zukünftigen Umsatzgenerierung

Investorenkapital und Fundraising-Aktivitäten

Fundraising-Aktivität	Erhöhter Betrag	Datum
Öffentliches Angebot	12,5 Millionen US-Dollar	November 2023
Privatplatzierung	5,2 Millionen US-Dollar	März 2023

Gesamtumsatz für 2023: 2,25 Millionen US-Dollar

Monopar Therapeutics Inc. (MNPR) - Canvas Business Model: Value Propositions

You're looking at the core value Monopar Therapeutics Inc. is trying to deliver to its customer segments-patients and prescribers-through its distinct pipeline assets. This isn't just about having drugs; it's about what those drugs do that others don't, or don't do as well. The value propositions center on two main areas: a late-stage treatment for a rare disease and a novel radiopharmaceutical platform for oncology.

Here's the quick math on the pipeline assets that define the current value proposition:

Asset	Indication/Use	Key Clinical/Development Status (Late 2025)	Key Efficacy/Benefit Data Point
ALXN1840	Wilson Disease (WD)	Preparing NDA submission to FDA in early 2026	Median treatment duration of approximately 2.63 years showed sustained improvements on the Unified Wilson Disease Rating Scale (UWDRS) Part II and Part III
MNPR-101-Lu	Therapeutic for uPAR-expressing advanced solid tumors	Phase 1a dose-escalation trial active and recruiting; FDA IND cleared September 26, 2025	Combines MNPR-101 with therapeutic radioisotope lutetium-177; first patient dosed under compassionate use for metastatic pancreatic cancer
MNPR-101-Zr	Diagnostic imaging agent for patient selection	Ongoing first-in-human imaging and dosimetry clinical trial	MNPR-101 antibody targets uPAR, which is expressed in tumors like pancreatic, ovarian, triple-negative breast, and colorectal cancers

For ALXN1840, the value is in providing a potential once-daily oral treatment that addresses both neurological and hepatic manifestations of Wilson Disease, a rare genetic condition causing toxic copper buildup. Data presented in late 2025 pooled efficacy from three trials (n=255) and safety from four trials (n=266). Specifically, in the Phase 2 ALXN1840-WD-204 copper balance study, treatment led to a rapid and sustained improvement in daily copper balance among the eight treated patients. This is critical because the 7 major Wilson Disease markets were valued at USD 326.0 Million in 2024, with projections suggesting growth to around USD 452.8 Million by 2034.

The radiopharmaceutical programs, MNPR-101-Lu (therapy) and MNPR-101-Zr (imaging), offer a targeted approach to advanced oncology. The value here is precision: using MNPR-101 to selectively target the urokinase plasminogen activator receptor (uPAR), which is found in aggressive tumors. This selectivity aims to deliver the therapeutic payload (lutetium-177 in MNPR-101-Lu) to kill cancer cells while minimizing damage to healthy tissue. The overall Solid Tumor Therapeutics Market was valued at USD 207.29 billion in 2025, expected to reach USD 307.41 billion by 2030.

Monopar Therapeutics Inc. is positioning itself to address these high unmet needs with a focused financial runway. The company reported cash, cash equivalents and investments of $143.7 million as of September 30, 2025. This funding is expected to support operations, including the NDA assembly for ALXN1840 and the continuation of the MNPR-101 trials, at least through December 31, 2027. The R&D expenses for the third quarter of 2025 were $2,589,749, up from $984,278 in Q3 2024, reflecting increased manufacturing and personnel costs. The net loss for Q3 2025 was $3.4 million, or $0.48 per share.

The value proposition is built on these tangible milestones and market opportunities:

• ALXN1840: Potential for long-term neurological and hepatic benefit in Wilson Disease patients.
• MNPR-101-Lu: First-in-human therapeutic trial for a uPAR-targeted radiopharma in advanced solid tumors.
• MNPR-101-Zr: Tool to select patients likely to benefit from the Lu-177 therapy.
• Addressing Rare Disease Market: Targeting a market segment valued at roughly $500 million in 2025.
• Addressing Oncology Market: Targeting the broad Solid Tumor Therapeutics Market, valued at USD 207.29 billion in 2025.
• Financial Runway: Expectation to continue operations through December 31, 2027 with current cash reserves.

The company is defintely focused on de-risking these assets through clinical data presentations at major meetings like AASLD 2025 and ANA 2025.

Finance: draft 13-week cash view by Friday.

Monopar Therapeutics Inc. (MNPR) - Canvas Business Model: Customer Relationships

You're managing relationships in a clinical-stage biotech, so your key customers aren't just patients; they're the investigators driving the science and the investors funding the journey. Monopar Therapeutics Inc. focuses its relationship strategy on these critical groups.

High-touch, direct engagement with clinical investigators and key medical experts

Direct engagement with the medical community is central to Monopar Therapeutics Inc.'s strategy, especially as its radiopharmaceutical programs, MNPR-101-Zr (imaging) and MNPR-101-Lu (therapy), are in Phase 1/Phase 1a clinical trials in Australia.

This relationship building involves presenting clinical data at major medical meetings to engage key opinion leaders. For instance, new data on ALXN1840 for Wilson Disease was presented at the 150th American Neurological Association (ANA) Annual Meeting on September 14-15, 2025, and again at The Liver Meeting® 2025 (AASLD) on November 9, 2025.

The nature of these interactions is highly specialized, focusing on scientific exchange with experts like Professor Matthew Lorincz and Professor Aftab Ala.

• Phase 1/1a clinical trials for MNPR-101 are active and enrolling in Australia.
• Data presentations target specialized audiences like hepatologists and neurologists.
• Engagement supports the development of the late-preclinical stage MNPR-101-Ac program.

Regulatory relationship management with the FDA for NDA submission

Managing the relationship with the U.S. Food and Drug Administration (FDA) is a high-stakes, formal process. Monopar Therapeutics Inc. is actively preparing for a significant regulatory milestone with its late-stage asset, ALXN1840, for Wilson Disease.

The company is preparing to submit a New Drug Application (NDA) to the FDA in early 2026. This follows the official transfer of the Investigational New Drug (IND) application sponsorship for ALXN1840 from Alexion Pharmaceuticals, effective June 6, 2025, and acknowledged by the FDA on July 29, 2025. Furthermore, Monopar Therapeutics Inc. received FDA clearance on its IND application for MNPR-101-Lu on September 26, 2025.

Here's a quick look at key regulatory interactions as of late 2025:

Regulatory Event/Program	Key Date/Timeline	Status/Action
ALXN1840 NDA Submission	Early 2026	Preparation for submission underway
ALXN1840 IND Sponsorship Transfer	Effective June 6, 2025	Transfer acknowledged by FDA on July 29, 2025
MNPR-101-Lu IND Clearance	September 26, 2025	Clearance received for Phase 1 trial protocol

Investor relations and communication via SEC filings and press releases

Investor relationships are managed through transparent, regular reporting, which is crucial for a clinical-stage company that relies on capital markets. You need to keep the street informed on cash position and development progress.

As of September 30, 2025, Monopar Therapeutics Inc. reported $143.7 million in cash, cash equivalents, and investments. The company projects these funds will be sufficient to continue operations at least through December 31, 2027. The third quarter of 2025 General & Administrative (G&A) expenses were $1,503,326. The Chief Financial Officer, Quan Vu, serves as the primary contact for investor relations inquiries.

Key communication touchpoints include:

• Filing the Quarterly Earnings Report (10-Q) on November 13, 2025, for the period ended September 30, 2025.
• Filing a shelf registration statement on Form S-3 on August 29, 2025, for up to $300,000,000 in securities.
• Shareholder support for executive compensation at the June 2025 Annual Meeting was 99.8% (4,382,795 votes for).

Expanded Access Program (compassionate use) for MNPR-101 in the U.S.

For patients with serious or life-threatening conditions where no satisfactory alternative exists, the Expanded Access Program (EAP) provides a direct, albeit limited, relationship channel. Monopar Therapeutics Inc. established this program in collaboration with Excel Diagnostics and Nuclear Oncology Center (EDNOC).

The physician-sponsored EAP for the investigational imaging agent MNPR-101-Zr and therapeutic agent MNPR-101-Lu received authorization to proceed from the FDA on June 11, 2025. This program is active and enrolling patients in the U.S.. The agents are designed to target challenging cancers, including triple-negative breast, pancreatic, and colorectal cancers.

The EAP is intended to serve as a potential pathway for access outside of formal clinical trials preceding FDA approval. Finance: draft 13-week cash view by Friday.

Monopar Therapeutics Inc. (MNPR) - Canvas Business Model: Channels

You're looking at how Monopar Therapeutics Inc. gets its clinical data and, eventually, its products to the right people. For a clinical-stage company, the channels are heavily weighted toward research and regulatory interaction right now, but the groundwork for commercialization is being laid.

Clinical trial sites in Australia and the United States for drug development

The primary channels for Monopar Therapeutics Inc.'s drug development are the active clinical trial sites. For the radiopharmaceutical pipeline targeting advanced cancers, the focus is on the MNPR-101 program.

The MNPR-101-Zr Phase 1 (imaging and dosimetry) and MNPR-101-Lu (therapeutic) Phase 1a clinical trials are actively enrolling patients in Australia. The first site activated for the MNPR-101-Lu trial was the Melbourne Theranostic Innovation Centre (MTIC) in Australia. In the U.S., access is currently provided through a physician-sponsored Expanded Access Program (EAP) for MNPR-101-Zr and MNPR-101-Lu, which is authorized by the FDA and enrolling at Excel Diagnostics and Nuclear Oncology Center (EDNOC) in Houston, Texas.

Here's a quick look at the current trial structure supporting these channels:

Trial/Program	Phase/Status	Primary Location	Identifier/Site Example
MNPR-101-Zr	Phase 1 (Imaging/Dosimetry)	Australia	NCT06337084
MNPR-101-Lu	Phase 1a (Therapeutic)	Australia	NCT06617169
MNPR-101-Zr & MNPR-101-Lu	Expanded Access Program (EAP)	U.S.	EDNOC, Houston, Texas

The investment in these channels is visible in the financials; R&D expenses for the first quarter of 2025 included a $69,000 increase attributed to clinical trial site activity related to MNPR-101.

Scientific and medical conferences (e.g., AASLD, ANA) for data dissemination

Disseminating clinical data is a critical channel for building credibility and attracting future partners or investors. Monopar Therapeutics Inc. has actively used major medical meetings for its late-stage ALXN1840 program for Wilson disease.

The key dissemination events as of late 2025 include:

• Presented long-term efficacy and safety data for ALXN1840 at the European Association for the Study of the Liver (EASL) International Liver Congress 2025 on May 7, 2025.
• Presented new data on ALXN1840 neurological efficacy at the 150th American Neurological Association (ANA) Annual Meeting on September 14-15, 2025.
• Presented new data from the Phase 2 ALXN1840-WD-204 copper balance study at the American Association for the Study of Liver Diseases (AASLD) - The Liver Meeting® 2025 on November 9, 2025.

The data shared at EASL included pooled results from three clinical trials (n=255) and safety data from an additional Phase 2 study with n=266 patients. These presentations are key to demonstrating the potential of ALXN1840 over the standard of care.

Direct communication with regulatory bodies (FDA) for drug approval

Direct engagement with the U.S. Food and Drug Administration (FDA) is the most crucial channel for bringing a drug to market. Monopar Therapeutics Inc. is managing two major regulatory tracks.

For ALXN1840, the company is preparing to submit a New Drug Application (NDA) to the FDA in early 2026. This program required a formal transfer of the Investigational New Drug (IND) application sponsorship from Alexion Pharmaceuticals, which the FDA acknowledged as effective on June 6, 2025.

For the radiopharmaceutical program, Monopar Therapeutics Inc. received FDA clearance on its IND application for MNPR-101-Lu on September 26, 2025, covering the protocol for a Phase 1, Open-Label, Multicenter, Dosimetry and Dose-Escalation Trial.

The company's current cash position, reported at $143.7 million as of September 30, 2025, is expected to fund operations, including assembling the regulatory package and filing the NDA for ALXN1840, through at least December 31, 2027.

Future commercial sales channel through specialty pharmacy and distribution networks

While the current focus is on clinical execution and regulatory submission, the path to commercialization for ALXN1840 involves establishing future sales channels. Monopar Therapeutics Inc. took full responsibility for the ALXN1840 program, including its commercial advancement. The company anticipates marketing products in the EU, the United Kingdom, and other jurisdictions in addition to the U.S. if approved. If successful, the commercial channel is expected to involve hiring sales representatives and conducting physician and patient association outreach outside the U.S.. Specific financial commitments or established contracts with specialty pharmacy or distribution networks as of late 2025 are not detailed in recent public filings, but the expectation of commercialization is baked into the funding runway extending through at least December 31, 2027.

Monopar Therapeutics Inc. (MNPR) - Canvas Business Model: Customer Segments

You're looking at the core groups Monopar Therapeutics Inc. (MNPR) needs to serve to get its pipeline to market, especially as they push for an NDA filing in early 2026. Here's the breakdown of those key customer segments based on late 2025 data.

Patients with Wilson Disease, a rare genetic disorder

This segment is focused on patients needing a treatment like ALXN1840 (tiomolybdate choline) for Wilson Disease, a rare genetic condition causing toxic copper buildup. The clinical evidence base is substantial, which directly informs this customer group.

• Pooled results from three clinical trials showed sustained clinical benefits over a median treatment duration of 2.63 years.
• Safety data, which included an additional Phase 2 study, involved n=266 patients.
• The Phase 2 ALXN1840-WD-204 copper balance study included 8 patients showing significant copper balance reduction.

The company is preparing to submit a New Drug Application (NDA) to the FDA for ALXN1840 in early 2026.

Oncology patients with uPAR-expressing advanced or metastatic solid tumors

This segment targets patients with aggressive cancers where the urokinase plasminogen activator receptor (uPAR) is expressed. The focus is on the MNPR-101 radiopharmaceutical programs.

Program	Target Indication Context	Clinical Stage (as of late 2025)
MNPR-101-Zr	Imaging agent for advanced cancers	Phase 1 (imaging and dosimetry) active and enrolling
MNPR-101-Lu	Therapeutic agent for advanced cancers	Phase 1a dose-escalation trial, IND cleared September 26, 2025
MNPR-101-Ac	Therapeutic agent for advanced cancers	Late preclinical stage, with plans to enter the clinic

Cancers mentioned as expressing uPAR include triple-negative breast, colorectal, and pancreatic cancers.

Clinical investigators and physicians specializing in hepatology, neurology, and oncology

These are the key opinion leaders and trial sites that validate and prescribe the treatments. While the exact number of specialists isn't public, their engagement is demonstrated by scientific presentations.

• Data on ALXN1840 were presented at the 150th American Neurological Association (ANA) Annual Meeting in September 2025.
• New data on ALXN1840 were presented at the American Association for the Study of Liver Diseases (AASLD) - The Liver Meeting® 2025 in November 2025.
• Data on ALXN1840 were presented at the European Association for the Study of the Liver (EASL) International Liver Congress 2025 in May 2025.

The company's R&D expenses for Q3 2025 were $2,589,749, reflecting ongoing clinical trial site activity and personnel costs.

Institutional and retail investors funding the pre-revenue operations

This segment provides the necessary capital to fund the clinical development and regulatory path. The company's financial position as of the end of Q3 2025 is a key data point for this group.

Here's the quick math on liquidity as of September 30, 2025:

Financial Metric	Amount (as of 9/30/2025)
Cash, Cash Equivalents, and Investments	$143.7 million
Projected Runway Through	December 31, 2027
Gross Proceeds Raised in September 2025 Offering	$126.9 million
Net Loss for Q3 2025	$3.4 million
R&D Expenses for Q3 2025	$2,589,749
G&A Expenses for Q3 2025	$1,503,326

Alexion, AstraZeneca Rare Disease ("AZ") is a significant stakeholder, having received 9.9% ownership of Monopar's outstanding common stock in October 2024 for the ALXN1840 license. The net loss for Q3 2025 was $0.48 per share. Finance: draft 13-week cash view by Friday.

Monopar Therapeutics Inc. (MNPR) - Canvas Business Model: Cost Structure

You're looking at the expenses that fuel Monopar Therapeutics Inc.'s pipeline, which is heavily weighted toward clinical development and regulatory readiness as of late 2025. The cost structure is dominated by the push to get ALXN1840 ready for its targeted early 2026 New Drug Application (NDA) submission to the FDA, alongside advancing the radiopharmaceutical programs.

The operating expenses saw a significant step-up following the September 2025 capital raise, which was partly intended to cover these costs and extend the cash runway to at least December 31, 2027. The net loss for the nine months ending September 30, 2025, reached $8.5 million, up from $4.7 million in the same prior-year period, reflecting this accelerated burn rate.

Here's a look at the key components driving the cost base for the third quarter of 2025:

Expense Category	Q3 2025 Amount (USD)	Year-over-Year Change Driver
Research and Development (R&D) Expense	$2,589,749	Primarily driven by a $937,582 increase in manufacturing activities for ALXN1840 and a $617,667 rise in R&D personnel costs.
General and Administrative (G&A) Expense	$1,503,326	Largely due to a $369,959 increase in Board compensation from March 2025 stock option grants and a $287,749 increase in G&A personnel expenses.
Total Operating Expenses (R&D + G&A)	$4,093,075	Represents the core cash burn rate supporting current operations.

High research and development (R&D) expenses were reported at $2,589,749 in Q3 2025. This figure is a direct reflection of the increased activity across the pipeline.

General and administrative (G&A) costs totaled $1,503,326 for the third quarter of 2025. This increase, compared to $590,624 in Q3 2024, shows the cost of scaling up the corporate infrastructure to manage late-stage assets.

Clinical trial costs for Phase 1 programs and NDA preparation for ALXN1840 are embedded within the R&D spend. Monopar Therapeutics Inc. is actively conducting its first-in-human trials for the radiopharmaceuticals:

• MNPR-101-Zr Phase 1 (imaging and dosimetry) trial is active and enrolling.
• MNPR-101-Lu (therapeutic) Phase 1a clinical trial is active and enrolling in Australia.
• The company is focused on assembling the regulatory package for the ALXN1840 NDA submission targeted for early 2026.

Manufacturing costs for drug substance and finished product for clinical/regulatory use are a major component of the R&D increase. Specifically, manufacturing activities related to ALXN1840 accounted for an increase of $937,582 year-over-year in the R&D line item for Q3 2025.

Legal and regulatory fees associated with FDA submissions and IP protection contribute to the G&A structure. While Q3 data isn't broken out granularly for legal fees, Q2 2025 saw a $114,322 increase in legal fees year-over-year, indicating ongoing investment in regulatory navigation and intellectual property maintenance.

Finance: draft 13-week cash view by Friday.

Monopar Therapeutics Inc. (MNPR) - Canvas Business Model: Revenue Streams

Monopar Therapeutics Inc. is currently operating as a pre-commercial entity, meaning product sales are not yet a source of revenue.

For the third quarter of 2025, Monopar Therapeutics Inc. reported $0 in product sales revenue.

The primary non-equity income stream for Monopar Therapeutics Inc. as of late 2025 is interest income generated from its cash and investments balance. As of September 30, 2025, the company held $143.7 million in cash, cash equivalents, and investments. This substantial cash position supported an interest income of $655K for the third quarter of 2025.

Future revenue potential is tied to the successful clinical development and subsequent commercialization or partnering of its pipeline assets. The two main anticipated sources are:

• Future potential revenue from commercial sales of ALXN1840 post-FDA approval.
• Future potential revenue from commercial sales of MNPR-101 radiopharmaceuticals.

The company is preparing to submit a New Drug Application (NDA) for ALXN1840 to the U.S. Food and Drug Administration (FDA) in early 2026. Analysts have speculated on the peak sales potential for ALXN1840, estimating it could reach approximately $500 million if approved.

The radiopharmaceutical pipeline, centered on MNPR-101, is advancing through clinical trials, which represents another significant, though less quantified, future revenue vector. This includes the MNPR-101-Lu therapeutic agent in Phase 1a trials and the MNPR-101-Ac program in late preclinical stages.

Here's a look at the current and near-term potential revenue components for Monopar Therapeutics Inc.:

Revenue Component	Status as of Late 2025	Associated Financial/Statistical Data
Product Sales (Commercial)	Pre-revenue	$0 in product sales for Q3 2025
Interest Income on Cash Holdings	Current Income Stream	$655K in Q3 2025; Cash balance of $143.7 million as of September 30, 2025
ALXN1840 Commercial Sales (Future)	NDA filing targeted for early 2026	Projected peak sales potential of approximately $500 million
MNPR-101 Radiopharmaceutical Sales (Future)	MNPR-101-Lu in Phase 1a; MNPR-101-Ac in late preclinical	No specific revenue projection stated; potential for licensing or collaboration income

Future revenue streams from licensing or collaboration agreements for pipeline assets are an inherent part of the model, given the company holds global rights to its PRIT platform, initially developed through academic partnerships. The company is focused on advancing its pipeline to maximize this potential.

The near-term focus is on achieving the NDA submission for ALXN1840, which is the clearest path to generating product revenue. If onboarding takes longer than expected, the cash runway extends to at least December 31, 2027, based on current funds. Finance: draft 13-week cash view by Friday.