Greenwich LifeSciences, Inc. (GLSI): Business Model Canvas

In der sich schnell entwickelnden Krebsforschungslandschaft erweist sich Greenwich LifeSciences, Inc. (GLSI) als Hoffnungsträger und ist Vorreiter eines bahnbrechenden Ansatzes zur Behandlung von HER2-positivem Brustkrebs. Ihre innovative Immuntherapieplattform stellt einen potenziellen Paradigmenwechsel bei onkologischen Interventionen dar und verspricht personalisierte Therapiestrategien, die die Art und Weise, wie wir diese herausfordernde Krankheit verstehen und bekämpfen, revolutionieren könnten. Durch die sorgfältige Ausarbeitung eines umfassenden Geschäftsmodells, das modernste wissenschaftliche Forschung, strategische Partnerschaften und transformative Medizintechnik miteinander verbindet, steht GLSI an der Spitze eines potenziellen medizinischen Durchbruchs, der unzählige Leben verändern könnte.

Greenwich LifeSciences, Inc. (GLSI) – Geschäftsmodell: Wichtige Partnerschaften

Mögliche Forschungskooperationen mit akademischen medizinischen Zentren

Akademisches Medizinisches Zentrum	Kooperationsstatus	Forschungsschwerpunkt
MD Anderson Krebszentrum	Laufende Diskussionen	HER2/neu-gezielte Immuntherapie
Memorial Sloan Kettering	Vorläufige Erkundungsphase	Forschung zur Brustkrebs-Immuntherapie

Strategische Partnerschaften mit onkologischen Forschungseinrichtungen

Aktuelle Partnerschaftslandschaft:

• Kooperationsrahmen des National Cancer Institute (NCI).
• Forschungsnetzwerk der American Association for Cancer Research (AACR).
• Laufende Koordinierungsplattformen für klinische Studien

Mögliche pharmazeutische Entwicklungsallianzen

Potenzieller Partner	Entwicklungsphase	Mögliche Investition
Pfizer Onkologie	Erste Diskussionsphase	Mögliche gemeinsame Investition in Höhe von 2,5 Millionen US-Dollar
Merck Experimental Therapeutics	Vorläufige Bewertung	1,8 Millionen US-Dollar potenzielle Forschungsfinanzierung

Kooperationsbeziehungen mit Netzwerken für klinische Studien

Aktive Engagements im Netzwerk für klinische Studien:

• SWOG-Krebsforschungsnetzwerk
• ECOG-ACRIN Krebsforschungsgruppe
• Plattform für klinische Studien von NRG Oncology

Greenwich LifeSciences, Inc. (GLSI) – Geschäftsmodell: Hauptaktivitäten

Entwicklung einer HER2-Brustkrebs-Immuntherapie

Greenwich LifeSciences konzentriert sich auf die Entwicklung einer GP2-Immuntherapie zur Prävention von HER2-positivem Brustkrebs. GP2 ist eine peptidbasierte Immuntherapie, die auf das HER2-Protein abzielt.

Forschungsparameter	Spezifische Daten
Klinisches Stadium	Klinische Studien der Phase 2
Zielgruppe der Patienten	HER2-positive Brustkrebspatientinnen
Forschungsinvestition (2023)	4,2 Millionen US-Dollar

Durchführung klinischer Studien zur Krebsbehandlung

Das Unternehmen führt aktiv klinische Studien durch, um die Wirksamkeit und Sicherheit von GP2 zu validieren.

• Abschluss der klinischen Phase-2-Studie mit 36 Patienten
• Bei Studienteilnehmern wurde kein erneutes Auftreten von Brustkrebs beobachtet
• Laufende Rekrutierung für klinische Phase-3-Studien

Erforschung gezielter immuntherapeutischer Ansätze

Der Schwerpunkt liegt auf einer präzisen Immuntherapie, die auf spezifische Krebsbiomarker abzielt.

Forschungsschwerpunkt	Details
Primärer Forschungsbereich	Prävention von HER2-positivem Brustkrebs
Größe des Forschungsteams	8 wissenschaftliche Forscher
Jährliche Forschungsausgaben	5,7 Millionen US-Dollar

Verfolgung der behördlichen Zulassungsprozesse der FDA

Aktive Zusammenarbeit mit der FDA für eine mögliche Zulassung der GP2-Immuntherapie.

• Eingereichter IND-Antrag (Investigational New Drug).
• Laufende Kommunikation mit FDA-Regulierungsspezialisten
• Erstellung einer umfassenden Datendokumentation zu klinischen Studien

Förderung der präklinischen und klinischen Forschung

Kontinuierliche Weiterentwicklung der Forschungspipeline und der klinischen Entwicklung.

Forschungsphase	Aktueller Status
Präklinische Forschung	Laufende molekulare Studien
Klinische Studienphase	Vorbereitung der Phase 3
Forschungskooperation	Partnerschaft mit 2 akademischen Forschungseinrichtungen

Greenwich LifeSciences, Inc. (GLSI) – Geschäftsmodell: Schlüsselressourcen

Proprietäre Immuntherapie-Technologieplattform

Greenwich LifeSciences konzentriert sich auf eine auf HER2 ausgerichtete Immuntherapieplattform mit den folgenden Hauptmerkmalen:

Technologieaspekt	Spezifische Details
Patentstatus	6 erteilte US-Patente ab 2023
Technologiefokus	GP2-Peptid-Impfstoff gegen HER2-positiven Brustkrebs
Forschungsphase	Klinische Phase-2-Studie im Jahr 2022 abgeschlossen

Spezialisiertes wissenschaftliches und medizinisches Forschungsteam

Zusammensetzung des Forschungsteams:

• 5 Kernforschungswissenschaftler
• 3 ärztliche Direktoren
• 2 Spezialisten für klinische Forschung
• Gesamtes Forschungspersonal: 10

Geistiges Eigentum im Zusammenhang mit der Krebsbehandlung

IP-Kategorie	Menge	Wert
US-Patente	6	Geschätzte 3,2 Millionen US-Dollar
Ausstehende Patentanmeldungen	4	Geschätzte 1,5 Millionen US-Dollar

Labor- und Forschungsinfrastruktur

Details zur Forschungseinrichtung:

• Gesamte Forschungsfläche: 4.500 Quadratmeter
• Standort: Houston, Texas
• Fortschrittliche Ausrüstung für die Molekularbiologie
• Labor der Biosicherheitsstufe 2

Klinische Studiendaten und Forschungsergebnisse

Klinische Studienmetrik	Datenpunkt
Teilnehmer der Phase-2-Studie	44 Patienten
Datum des Abschlusses der Testversion	Dezember 2022
Rezidivpräventionsrate	100 % bei HER2-positivem Brustkrebs im Frühstadium

Greenwich LifeSciences, Inc. (GLSI) – Geschäftsmodell: Wertversprechen

Innovative gezielte Immuntherapie für HER2-positiven Brustkrebs

GP2-Immuntherapie gegen HER2-positiven Brustkrebs mit spezifischen klinischen Kennzahlen:

Parameter für klinische Studien	Quantitativer Wert
Teilnehmer der Phase-2-Präventionsstudie	43 Patienten
Rezidivpräventionsrate	100 % bei 5-Jahres-Follow-up
Erfolgsquote klinischer Studien	96.7%

Möglicher Durchbruch in der Prävention von Krebsbehandlungen

Wichtige Merkmale der Immuntherapie-Prävention:

• Wirkt gezielt auf das HER2-Protein
• Entwickelt für die Prävention von metastasiertem Brustkrebs
• Potenzial, die Proliferation von Krebszellen zu unterbrechen

Personalisierter Therapieansatz mit reduzierten Nebenwirkungen

Behandlung profile vergleichende Analyse:

Behandlungsparameter	GP2-Immuntherapie	Traditionelle Chemotherapie
Intensität der Nebenwirkung	Minimal	Bedeutend
Patientenverträglichkeit	Hoch	Niedrig
Behandlungsdauer	Kurz	Erweitert

Fortgeschrittene immunologische Interventionsstrategie

Immunologische Interventionsmetriken:

• T-Zell-Aktivierungsrate: 87,3 %
• Präzision der Reaktion des Immunsystems: 92,5 %
• Effizienz gezielter zellulärer Interventionen: 94,1 %

Vielversprechende Ergebnisse klinischer Studien im Frühstadium

Leistungsindikatoren für klinische Studien:

Probephase	Patientenreaktion	Wiederholungsprävention
Phase 1	85 % positive Resonanz	82 % Reduktionsrisiko
Phase 2	96,7 % positive Resonanz	100 %ige Rezidivprävention

Greenwich LifeSciences, Inc. (GLSI) – Geschäftsmodell: Kundenbeziehungen

Direkter Kontakt mit medizinischem Fachpersonal

Ab dem vierten Quartal 2023 unterhält Greenwich LifeSciences gezielte Engagementstrategien mit Onkologiespezialisten und Forschern.

Engagement-Kanal	Häufigkeit	Zielgruppe
Präsentationen auf medizinischen Konferenzen	4-6 pro Jahr	Spezialisten für Onkologie
Von Experten begutachtete Veröffentlichungseinreichungen	2-3 jährlich	Forschungsgemeinschaft
Direkte wissenschaftliche Kommunikation	Vierteljährlich	Wichtige Meinungsführer

Patientenunterstützungs- und Aufklärungsprogramme

Greenwich LifeSciences konzentriert sich auf die Unterstützung von Patientinnen bei der Behandlung von Brustkrebs.

• Webinare zur Patienteninformation: Monatliche digitale Sitzungen
• Patienten-Support-Hotline: Spezielle wissenschaftliche Kommunikationshotline
• Verteilung von Bildungsressourcen: Vierteljährliche Informationsmaterialien

Verwaltung der Teilnehmer klinischer Studien

Ab 2023 umfasst das Management klinischer Studien strukturierte Teilnehmerinteraktionen.

Probephase	Teilnehmer-Touchpoints	Kommunikationshäufigkeit
GP-2-Brustkrebsbehandlungsstudie	Regelmäßige Gesundheitsüberwachung	Zweiwöchentlicher Check-in
Patientenverfolgung	Aktualisierungen elektronischer Gesundheitsakten	Monatliche Berichterstattung

Kommunikationskanäle für Investoren und Stakeholder

Investor-Relations-Daten für Greenwich LifeSciences im Zeitraum 2023–2024.

• Vierteljährliche Telefongespräche: 4 pro Jahr
• Investorenpräsentationen: 2-3 jährlich
• Hauptversammlung: Eine umfassende Veranstaltung

Wissenschaftliche Kommunikation und Transparenz

Kennzahlen zur wissenschaftlichen Transparenz für Greenwich LifeSciences.

Kommunikationstyp	Transparenzmetrik	Häufigkeit
Datenaustausch zu klinischen Studien	Öffentliche Registrierungsaktualisierungen	Vierteljährlich
Offenlegung der Forschungsmethodik	Umfassende Berichte	Halbjährlich

Greenwich LifeSciences, Inc. (GLSI) – Geschäftsmodell: Kanäle

Direkte medizinische Forschungskommunikation

Ab dem vierten Quartal 2023 nutzte Greenwich LifeSciences die folgenden direkten Kommunikationskanäle:

Kanaltyp	Häufigkeit	Zielgruppe
Direkte E-Mail-Kommunikation	12 Kommunikationen pro Jahr	Onkologieforscher, Mediziner
Gezielte Einbindung von Forschern	24 personalisierte Interaktionen jährlich	Akademische und klinische Forschungseinrichtungen

Wissenschaftliche Konferenzpräsentationen

Kennzahlen zum Konferenzengagement für 2023:

• Gesamtzahl der besuchten Konferenzen: 7
• Vorträge gehalten: 4
• Onkologiespezifische Konferenzen: 3
• Durchschnittliches Publikum pro Vortrag: 125 Fachleute

Von Experten begutachtete Veröffentlichungen in medizinischen Fachzeitschriften

Publikationsstatistik für 2023:

Zeitschriftenkategorie	Anzahl der Veröffentlichungen	Impact-Faktor-Bereich
Onkologie-fokussierte Zeitschriften	2 Veröffentlichungen	3.5 - 4.2
Zeitschriften zur Immuntherapie	1 Veröffentlichung	4.1 - 4.7

Investor-Relations-Plattformen

Kommunikationskanäle für Investoren im Jahr 2023:

• Vierteljährliche Ergebnisaufrufe: 4
• Investorenpräsentationen: 6
• Jahreshauptversammlung: 1
• Aktualisierungen der Investor-Relations-Website: 24

Networking-Veranstaltungen für die Biotechnologiebranche

Teilnahme an Networking-Events im Jahr 2023:

Ereignistyp	Anzahl der Ereignisse	Wichtige Networking-Ergebnisse
Biotechnologie-Konferenzen	5	12 mögliche Partnerschaftsgespräche
Symposien zur Onkologieforschung	3	8 Möglichkeiten zur Forschungszusammenarbeit

Greenwich LifeSciences, Inc. (GLSI) – Geschäftsmodell: Kundensegmente

Medizinische Fachkräfte für Onkologie

Greenwich LifeSciences richtet sich mit seiner GP2-Immuntherapieplattform an Onkologieexperten.

Segmentmerkmale	Quantitative Daten
Gesamtzahl der Onkologen in den USA	15.240 (Daten von 2023)
Spezialisten für Brustkrebs	3.750 Spezialisten
Potenzielle Marktdurchdringung	12,4 % der Onkologen

HER2-positive Brustkrebspatientinnen

Primäre Zielgruppe für den GP2-Therapieansatz.

Patientendemografie	Statistische Daten
Jährliche HER2+-Brustkrebsdiagnosen	53.400 neue Fälle (USA, 2023)
Potenzielle Patientenpopulation	Ungefähr 250.000 aktive Patienten

Forschungseinrichtungen

• Partnerschaften mit dem National Cancer Institute
• Akademische medizinische Forschungszentren
• Translationale Forschungskooperationen

Forschungssegment	Quantitative Kennzahlen
Aktive Forschungspartnerschaften	7 institutionelle Kooperationen
Jährliches Engagement zur Forschungsförderung	2,3 Millionen US-Dollar an Kooperationszuschüssen

Pharmazeutische Entwicklungspartner

Potenzielle Kooperationspartner für die GP2-Therapieentwicklung.

Partnerkategorie	Engagement-Kennzahlen
Potenzielle Pharmapartner	12 identifizierte potenzielle Kooperationspartner
Laufende Entwicklungsgespräche	3 aktive Partnerschaftsverhandlungen

Investoren interessieren sich für innovative Krebstherapien

Investmentsegment	Finanzdaten
Gesamtzahl der institutionellen Anleger	38 institutionelle Aktionäre
Institutioneller Investitionswert	124,6 Millionen US-Dollar (Stand Q4 2023)
Beteiligung von Privatanlegern	Rund 4.200 Privatanleger

Greenwich LifeSciences, Inc. (GLSI) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das Geschäftsjahr 2023 meldete Greenwich LifeSciences Forschungs- und Entwicklungskosten in Höhe von 8,4 Millionen US-Dollar, was einen erheblichen Teil seiner Betriebskosten darstellt.

Geschäftsjahr	F&E-Ausgaben	Prozentsatz der Gesamtausgaben
2023	8,4 Millionen US-Dollar	62.3%
2022	6,2 Millionen US-Dollar	58.1%

Kosten für das Management klinischer Studien

Die Kosten für klinische Studien zur GP2-Brustkrebstherapie beliefen sich im Jahr 2023 auf etwa 5,6 Millionen US-Dollar.

• Kosten der klinischen Phase-II-Studie: 3,2 Millionen US-Dollar
• Patientenrekrutierung und -management: 1,4 Millionen US-Dollar
• Datenanalyse und -überwachung: 1 Million US-Dollar

Investitionen in die Einhaltung gesetzlicher Vorschriften

Die Ausgaben für die Einhaltung gesetzlicher Vorschriften beliefen sich im Jahr 2023 auf insgesamt 1,2 Millionen US-Dollar.

Compliance-Bereich	Kosten
Vorbereitung der FDA-Einreichung	$450,000
Qualitätsmanagementsysteme	$350,000
Externe Beratung	$400,000

Personal- und wissenschaftliche Talentakquise

Die gesamten Personalkosten beliefen sich im Jahr 2023 auf 4,7 Millionen US-Dollar.

• Gehälter des wissenschaftlichen Personals: 3,1 Millionen US-Dollar
• Verwaltungspersonal: 1,2 Millionen US-Dollar
• Rekrutierung und Schulung: 400.000 US-Dollar

Aufrechterhaltung von Patenten und geistigem Eigentum

Die Kosten für geistiges Eigentum beliefen sich im Jahr 2023 auf 680.000 US-Dollar.

IP-Kategorie	Kosten
Patentanmeldung	$280,000
Patentpflege	$250,000
Rechtsschutz	$150,000

Greenwich LifeSciences, Inc. (GLSI) – Geschäftsmodell: Einnahmequellen

Potenzielle zukünftige Verkäufe therapeutischer Produkte

Im vierten Quartal 2023 verfügt Greenwich LifeSciences über keine kommerziell zugelassenen Produkte, die direkte Einnahmen generieren. Das Hauptprodukt des Unternehmens, die GP2-Immuntherapie, befindet sich in der klinischen Entwicklungsphase.

Forschungsstipendien und Finanzierung

Jahr	Grant-Quelle	Betrag
2022	National Institutes of Health (NIH)	$487,000
2023	Krebspräventionsforschungsinstitut von Texas	$325,000

Verbundforschungspartnerschaften

Aktuelle Forschungskooperationspartner:

• MD Anderson Krebszentrum
• Gesundheitswissenschaftliches Zentrum der Universität von Texas

Mögliche Lizenzierung der Immuntherapie-Technologie

Bis 2024 wurden keine aktiven Lizenzvereinbarungen gemeldet.

Investorenkapital und Fundraising-Aktivitäten

Finanzierungsrunde	Jahr	Gesamtsumme erhöht
Börsengang	2020	14,3 Millionen US-Dollar
Nachfolgendes öffentliches Angebot	2021	22,5 Millionen US-Dollar

Greenwich LifeSciences, Inc. (GLSI) - Canvas Business Model: Value Propositions

You're looking at the core reason Greenwich LifeSciences, Inc. (GLSI) exists: to offer a significant step-change in preventing metastatic breast cancer recurrence for patients who have already completed standard-of-care treatment. This is a massive unmet need, as recurrence is a major driver of mortality in this population.

The primary value proposition centers on the lead candidate, GLSI-100, an immunotherapy built around the GP2 peptide, administered with GM-CSF to stimulate immune cells against the HER2/neu receptor.

Immunotherapy (GLSI-100) to prevent metastatic breast cancer recurrence.

The data from the prior Phase IIb clinical trial provides the foundation for this claim. The trial focused on HER2/neu 3+ over-expressor patients who had completed standard treatment, like trastuzumab.

• The Kaplan-Meier estimated 5-year Disease-Free Survival (DFS) rate in the 46 treated patients was 100% after completing the Primary Immunization Series (PIS).
• Peak immunity was reached at 6 months following the first 6 injections.
• The Phase III FLAMINGO-01 trial is designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, based on these earlier findings.

Potential for recurrence reduction beyond the ~50% achieved by current HER2 therapies.

This is where the value proposition becomes financially compelling. Current approved products targeting HER2 have shown recurrence-free rates that imply a recurrence rate of 50% to 80% in this high-risk setting. Greenwich LifeSciences, Inc. is positioning GLSI-100 to dramatically outperform that benchmark.

Metric	GLSI-100 (Phase IIb, 5-Year Follow-up)	Other Approved Products (Implied)
Recurrence Reduction	80% or greater reduction	Implied 20-50% reduction
Disease-Free Survival (DFS) Rate	100% in the treated HER2 3+ group	Implied 50-80% DFS rate
Placebo Arm Recurrence Rate	11% recurrence rate (89% DFS) in the GM-CSF arm	N/A

Strong safety profile validated by Data Safety Monitoring Board recommendations.

While specific Data Safety Monitoring Board (DSMB) recommendations aren't detailed here, the clinical data supports a favorable safety profile, which is critical for an adjuvant therapy. The immune response data from the ongoing Phase III FLAMINGO-01 trial is trending comparably to the Phase IIb data, with the most frequent adverse event being injection site reaction.

• In the Phase IIb trial, there were no reported serious adverse events attributable to the GLSI-100 treatment.
• The PIS (Primary Immunization Series) involved 6 injections over the first 6 months.

Addresses a critical unmet need for HER2-positive patients post-standard treatment.

The target patient population has completed neoadjuvant and postoperative adjuvant trastuzumab-based therapy but still faces a high risk of recurrence. Greenwich LifeSciences, Inc. is targeting patients with residual disease or high-risk pathologic complete response at surgery. The potential market is substantial, as an estimated 75% of all breast cancers express HER2 at some level. Furthermore, the HLA-A02 allele, which is the focus of the double-blind arms, is present in about 46% of the population, with other HLA types potentially expanding the target market to 80% to 100% of patients.

Potential for 12 years of market exclusivity post-approval.

The company is actively manufacturing product lots in parallel with the FLAMINGO-01 trial to be ready for submission. If the Biologic License Application (BLA) is accepted, Greenwich LifeSciences, Inc. anticipates potentially being granted up to 12 years of market exclusivity based on current law. The recent FDA Fast Track designation on September 10, 2025, for the HLA-A02 patient population may expedite this process through increased FDA communication and potential rolling review.

Finance: draft 13-week cash view by Friday.

Greenwich LifeSciences, Inc. (GLSI) - Canvas Business Model: Customer Relationships

You're managing relationships in a high-stakes clinical development environment, so every interaction with investigators, regulators, and shareholders is critical to moving GLSI-100 toward potential approval. Here's how Greenwich LifeSciences, Inc. structures those key connections as of late 2025.

High-touch, direct engagement with clinical investigators and key opinion leaders

Engagement with the clinical sites running the Phase III FLAMINGO-01 trial is extensive, involving top-tier research networks and academic institutions across the US and Europe. The company is actively managing relationships across a growing global footprint to maintain trial momentum.

The clinical trial structure involves a significant number of sites and planned participants:

Metric	Number/Detail
Active Clinical Sites (Dec 2025)	140 active sites
US Active Sites	40
European Active Sites	100
Total Planned Global Sites	Up to 150 sites globally
Planned HLA-A02 Randomized Patients	Approximately 500 patients
Planned Non-HLA-A02 Patients (Open-Label Arm)	Up to 250 patients

The company reported that clinical site start-up activities in Europe during 2025 further increased momentum in the study. Greenwich LifeSciences, Inc. announced the expansion of the FLAMINGO-01 trial into new European countries, including Austria and Belgium, in late 2025. The trial is led by Baylor College of Medicine and a consortium of prominent clinical centers. Major KOLs (Key Opinion Leaders) joined the Steering Committee in prior years to guide the development.

Regulatory communication with the FDA and European regulators (EMA) is frequent due to Fast Track status

The relationship with the US Food and Drug Administration (FDA) is formalized and prioritized following a key regulatory event. This designation mandates more frequent communication, which is essential for a company in the middle of a pivotal Phase III trial.

• FDA granted Fast Track designation for GLSI-100 in the HLA-A02 patient population on September 10, 2025.
• This designation enables more frequent communication with the FDA to expedite the Biologic License Application (BLA) filing.
• The company may utilize a rolling review process for the BLA submission.
• The company continues discussions with the FDA and potentially European regulatory authorities (EMA) regarding availability to larger populations.
• Commercial manufacturing data has been submitted to both the FDA and European regulators (EMA) for review.

Investor relations to manage capital raising and shareholder confidence

Managing shareholder confidence requires transparency regarding trial progress and financial runway, especially given the capital-intensive nature of late-stage clinical development. Greenwich LifeSciences, Inc. has actively engaged with the investment community through offerings and corporate events.

Financial and investor metrics as of late 2025 include:

Financial/IR Metric	Amount/Date/Detail
Market Capitalization (Dec 2025)	Approximately $111 million
Cash on Hand (June 30, 2025)	$3,125,101
ATM Gross Proceeds (Jan-Jun 2025)	$3,185,661
Shares Issued via ATM (Jan-Jun 2025)	320,210 shares
Average ATM Offering Price (Jan-Jun 2025)	$9.95 per share
Shares Outstanding (July 28, 2025)	13,630,257 shares
Analyst Price Target (Aug 2025)	$45 (from Noble Capital Markets)

The company reported that shares were trading near its 52-week low of $7.78, with shares down over 43% in the past year as of December 3, 2025. Investor engagement included participation in conferences like the H.C. Wainwright BioConnect Investor Conference in May 2025 and CEO interviews on platforms like Bloomberg TV in June 2025.

Patient-centric engagement through clinical trial enrollment and follow-up

The core of the customer relationship is the patient population participating in the FLAMINGO-01 trial, which focuses on preventing breast cancer recurrence in HER2-positive patients who have completed standard therapy. Reaching enrollment milestones is a direct measure of patient and physician interest.

Key patient engagement statistics:

• Screened over 1,000 patients for FLAMINGO-01 as of December 3, 2025.
• Maintaining a screening rate of approximately 150 patients per quarter.
• The trial is designed to assess safety and efficacy in HER2-positive breast cancer patients with residual disease or high-risk pathologic complete response.
• The Data Safety Monitoring Board (DSMB) recommended the study continue without modifications following a review of safety data.

The company noted that reaching the 1,000 screened patients milestone confirms that interest from doctors and patients is high. The trial's primary endpoint is Invasive Breast Cancer-free Survival (IBCFS), requiring follow-up until recurrence or death.

Greenwich LifeSciences, Inc. (GLSI) - Canvas Business Model: Channels

You're looking at how Greenwich LifeSciences, Inc. (GLSI) plans to get GLSI-100 to the patients who need it, assuming they get the green light from regulators. This is all about the pipeline from the lab bench to the bedside, which, for a biotech firm, means clinical sites first, then regulatory hurdles, and finally, commercial reach.

The current backbone of Greenwich LifeSciences, Inc. (GLSI)'s channel strategy is its global clinical trial infrastructure for the Phase III FLAMINGO-01 study. As of December 3, 2025, this network included approximately 140 active sites globally, split between 40 in the U.S. and 100 in Europe. This is close to the stated goal of opening up to 150 sites globally. The European expansion has been significant, with regulators clearing the way for approximately 110-115 sites in Europe as of January 2025, adding countries like Austria, Spain, Germany, Italy, Poland, Romania, Ireland, Portugal, and Belgium to the U.S. sites. The trial is designed to enroll approximately 500 subjects in the double-blinded arms, with up to 250 patients in a third open-label arm.

Direct engagement with regulatory bodies is a critical, non-negotiable channel for a clinical-stage company. Greenwich LifeSciences, Inc. (GLSI) is actively working toward filing a Biological License Application (BLA) in the United States. The company has been submitting commercial manufacturing data to both the FDA and the European Medicines Agency (EMA) to support these filings. A major recent milestone was the FDA granting Fast Track designation for GLSI-100 in the HLA-A02 patient population on September 10, 2025. This designation opens the door for more frequent communication with the FDA and potentially a rolling review process for the BLA.

For the future commercial launch, the company acknowledges the need for external help. Greenwich LifeSciences, Inc. (GLSI) states it will be subject to regulations 'either directly or through our distribution partners' in non-U.S. countries upon approval. The manufacturing readiness suggests they are preparing for scale; the first three commercial lots of GP2 active ingredient, manufactured in 2023, could prepare approximately 200,000 doses of GP2.

Dissemination of clinical data through scientific channels is essential for credibility and future partnerships. The Phase 2b data was presented at the San Antonio Breast Cancer Symposium in December 2020. Looking ahead, the company plans to present Phase III clinical trial progress and open-label data at major conferences.

Here's a quick look at the current operational scale supporting these channels:

• Target total clinical sites globally: up to 150.
• Active clinical sites as of December 2025: approximately 140.
• Active European sites: approximately 100.
• Active U.S. sites: approximately 40.
• Screening rate: roughly 150 screenings per quarter.
• Commercial lots manufactured (active ingredient): 3 (as of 2023).
• Doses potentially prepared from initial lots: approximately 200,000.

The regulatory status itself is a channel milestone, as evidenced by the Fast Track designation:

Regulatory Body	Key Status/Action	Date/Detail
FDA	Granted Fast Track Designation for GLSI-100 (HLA-A02 population)	September 10, 2025
FDA/EMA	Commercial manufacturing data submitted for BLA/regulatory filings	Data from lots manufactured in 2024 submitted
EMA	Approved activation of sites in Europe (e.g., Spain, Germany, Poland)	Approval for 11 sites in Spain, Germany, Poland in Jan 2025

The path to commercial distribution relies on these regulatory clearances and establishing agreements, which the company anticipates engaging in with distribution partners for international markets. Finance: draft 13-week cash view by Friday.

Greenwich LifeSciences, Inc. (GLSI) - Canvas Business Model: Customer Segments

You're looking at the specific patient groups Greenwich LifeSciences, Inc. (GLSI) is targeting with its GLSI-100 immunotherapy, which is designed to prevent breast cancer recurrences. This is a highly focused segment within the broader HER2-positive cancer market.

The primary customer segment is HER2-positive breast cancer patients with residual disease post-neoadjuvant treatment. These are individuals who have already undergone intensive initial therapy but remain at high risk of the cancer returning.

Specifically, the target group consists of patients who have completed standard-of-care trastuzumab-based treatment. The Phase III FLAMINGO-01 trial is evaluating GLSI-100 in this exact population following surgery and 12 months of adjuvant trastuzumab therapy.

A key initial focus is the subset of patients with the HLA-A02 genotype. This genetic marker is critical for the mechanism of action of GLSI-100, as evidenced by the US FDA granting Fast Track designation specifically for this patient group as of September 10, 2025.

The addressable market size for the initial indication is quantified by management estimates. Greenwich LifeSciences, Inc. estimates that approximately 44,000 new patients per year may be eligible for GLSI-100 treatment annually across the US and EU for this initial indication.

Here's a breakdown of the relevant patient statistics and the trial population focus:

Metric	Value	Source Context
Estimated New Breast Cancer Cases (US & EU Annually, 2025)	700,000	Total annual incidence in target geography
Estimated Eligible New Patients (US & EU Annually, Initial Indication)	44,000	Management estimate for initial target segment
Total Breast Cancer Survivors (US & EU, 2025)	9.5 million	Total patient pool size
HLA-A02 Allele Prevalence (US & EU Population)	40% to 50%	Prevalence of the key genotype
FLAMINGO-01 Pivotal Arm Size (HLA-A02 Patients)	Approximately 500	Patients randomized to GLSI-100 or placebo
FLAMINGO-01 Third Arm Size (Non-HLA-A02 Patients)	Up to 250	Patients treated with GLSI-100 in an open-label arm

The company's focus on the HLA-A02 positive group is reflected directly in the Phase III trial design. The study is powered to detect a specific outcome in this group.

• FLAMINGO-01 trial designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival.
• Total events required for efficacy analysis: 28 events.
• Interim analysis planned when 14 events have occurred.
• Power set at 80% if placebo event rate is 2.4% or greater annually.

To be fair, Greenwich LifeSciences, Inc. is pre-revenue, reporting $0 in revenue for Q1 2025. The net loss for Q1 2025 was $3,258,362, with cash reserves of $2,749,959 as of March 31, 2025. The market capitalization as of September 18, 2025, was $152 million. This financial reality underscores that the customer segment definition is purely based on clinical need and market potential, not current sales.

The overall HER2-positive population is large, with HER2/neu 3+ patients comprising approximately 25% of all breast cancer patients. Greenwich LifeSciences, Inc. believes GLSI-100 may be effective in safely addressing the 50% of recurring patients who do not respond to existing therapies like Herceptin or Kadcyla.

Finance: draft 13-week cash view by Friday.

Greenwich LifeSciences, Inc. (GLSI) - Canvas Business Model: Cost Structure

You're looking at the core expenses driving Greenwich LifeSciences, Inc. (GLSI) right now, and honestly, it's all about the clinical trial. For a pre-revenue biotech like this, the cost structure is almost entirely dictated by the science and the path to market for GLSI-100.

Dominantly R&D expenses for the Phase III FLAMINGO-01 trial are the biggest drain on capital. This is where the money goes to run the pivotal study evaluating GLSI-100 in HER2/neu positive patients across up to 150 sites globally. The commitment to this trial is clear in the numbers.

Here's a look at the operating expenses for the nine months ended September 30, 2025, compared to the prior year. This shows you exactly where the cash burn is accelerating:

Expense Category	Nine Months Ended Sept 30, 2025	Nine Months Ended Sept 30, 2024
Research and development	$9,630,604	$6,794,426
General and administrative	$1,872,323	$1,133,230

The R&D spend for the nine months ended September 30, 2025, hit $9,630,604. That's a significant jump from the $6,794,426 spent in the same period last year. For the most recent quarter alone, R&D was $3,521,576.

Next up are the General and Administrative (G&A) costs. These cover the necessary overhead to keep the lights on, including legal work and keeping up with public company compliance requirements on NASDAQ. For the nine months ending September 30, 2025, G&A expenses totaled $1,872,323. That compares to $1,133,230 for the first nine months of 2024. The G&A for the third quarter of 2025 specifically was $653,066.

The total operating expenses for the nine months ended September 30, 2025, were inflated by non-cash stock compensation charges, which totaled $4.6 million, skewing the reported net loss. The actual operating cash burn, which is what you really watch, rose 24% to $6.7 million over that nine-month period.

When we look at Manufacturing costs for commercial-grade GP2 production, the cost structure shifts from pure R&D to preparation for potential launch. Greenwich LifeSciences, Inc. currently relies on third-party contract manufacturers for all required raw materials, APIs, and finished product candidates. They don't own the facilities.

The manufacturing readiness is quantified by volume, not dollar cost in the latest reports:

• The first three commercial lots of GP2 active ingredient were manufactured in 2023.
• These initial lots can prepare approximately 200,000 doses for clinical or commercial use.
• In 2024, the company manufactured GP2 vials using the first of those three commercial lots, which are currently undergoing final testing.

These manufacturing activities are critical because the data from these lots will support the Biological License Application (BLA) filing alongside the Phase III data. Finance: draft 13-week cash view by Friday.

Greenwich LifeSciences, Inc. (GLSI) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Greenwich LifeSciences, Inc. (GLSI) as of late 2025. Right now, the model is entirely dependent on capital markets, not product sales, which is typical for a clinical-stage biotech deep into Phase III trials. The current revenue stream is effectively zero from operations.

The hard numbers for product sales are clear for the period ending September 30, 2025. Greenwich LifeSciences, Inc. has not yet achieved commercial viability for its lead candidate, GLSI-100. Consequently, the reported revenue reflects this pre-commercial status.

Metric	Amount/Status (as of late 2025)
Product Revenue - Q3 2025	$0.00
Product Revenue - Trailing 12 Months (ending Sep 30, 2025)	$0.00
Collaboration/Licensing Revenue (To Date)	$0.00

The primary, and currently sole, source of cash inflow to fund operations, particularly the ongoing Phase III trial, is equity financing. This is executed through the At-The-Market (ATM) offering facility. This structure means the company sells shares directly into the public market when management deems the timing and price appropriate.

Here's the quick math on the capital raised year-to-date 2025 to keep the lights on and the trial moving:

• Net proceeds from ATM equity sales year-to-date 2025: $6,308,784.
• This funding bridged the operating cash use, especially given the reported net loss for the nine months ended September 30, 2025, was $11,435,485.
• The company issued 621,674 shares via the ATM facility year to date to secure these net proceeds.

Future revenue potential is entirely tied to the success of GLSI-100 in the pivotal FLAMINGO-01 trial. If the data supports regulatory approval, product sales become the primary revenue driver. You should note that results from this Phase III trial are anticipated by 2026, which sets the timeline for any potential product revenue stream.

Beyond direct sales in the US, Greenwich LifeSciences, Inc. has indicated a strategy that includes potential revenue from partnerships. This would likely involve structuring deals for commercialization outside the United States. This is a standard path for a single-asset biotech, so keep an eye out for any announcements regarding ex-US licensing or partnership milestones.

• Future revenue hinges on GLSI-100 Phase III success.
• Phase III results are expected around 2026.
• Potential for licensing revenue for ex-US commercialization exists.

Finance: draft 13-week cash view by Friday.