Greenwich Lifesciences, Inc. (GLSI): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage rapide de la recherche sur le cancer en évolution, Greenwich Lifesciences, Inc. (GLSI) apparaît comme un phare d'espoir, pionnant une approche révolutionnaire du traitement du cancer du sein HER2 positif. Leur plate-forme d'immunothérapie innovante représente un changement potentiel de paradigme dans les interventions oncologiques, promettant des stratégies thérapeutiques personnalisées qui pourraient révolutionner la façon dont nous comprenons et combattre cette maladie difficile. En fabriquant méticuleusement un modèle commercial complet qui entrelace de recherche scientifique de pointe, de partenariats stratégiques et de technologie médicale transformatrice, GLSI est à l'avant-garde d'une percée médicale potentielle qui pourrait changer d'innombrables vies.

Greenwich Lifesciences, Inc. (GLSI) - Modèle commercial: partenariats clés

Collaborations de recherche potentielle avec des centres médicaux universitaires

Centre médical académique	Statut de collaboration	Focus de recherche
MD Anderson Cancer Center	Discussions en cours	Immunothérapie HER2 / Neu ciblée
Memorial Sloan Kettering	Phase exploratoire préliminaire	Recherche d'immunothérapie contre le cancer du sein

Partenariats stratégiques avec les institutions de recherche en oncologie

Paysage de partenariat actuel:

• Cadre de collaboration du National Cancer Institute (NCI)
• American Association for Cancer Research (AACR) Research Network
• Plateformes de coordination des essais cliniques en cours

Alliances possibles du développement pharmaceutique

Partenaire potentiel	Étape de développement	Investissement potentiel
Pfizer Oncology	Étape de discussion initiale	2,5 millions de dollars d'investissement collaboratif potentiel
Merck Experimental Therapeutics	Évaluation préliminaire	Financement potentiel de la recherche 1,8 million de dollars

Relations collaboratives avec les réseaux d'essais cliniques

Engagements de réseau d'essais cliniques actifs:

• Swog Cancer Research Network
• Groupe de recherche sur le cancer ECOG-ACRIN
• Plateforme d'essai cliniques en oncologie NRG

Greenwich Lifesciences, Inc. (GLSI) - Modèle d'entreprise: Activités clés

Développer l'immunothérapie du cancer du sein HER2

Greenwich LifeSciences se concentre sur le développement de l'immunothérapie GP2 pour la prévention du cancer du sein HER2 positif. Gp2 est une immunothérapie à base de peptide ciblant la protéine HER2.

Paramètre de recherche	Données spécifiques
Étape clinique	Essais cliniques de phase 2
Cible de la population de patients	Patientes atteintes d'un cancer du sein HER2-positif
Investissement en recherche (2023)	4,2 millions de dollars

Effectuer des essais cliniques pour le traitement du cancer

La société mène activement des essais cliniques pour valider l'efficacité et la sécurité de GP2.

• Essai clinique de phase 2 terminé avec 36 patients
• Zéro récurrence du cancer du sein observé chez les participants à l'essai
• Recrutement d'essais cliniques de phase 3 en cours

Rechercher des approches immunothérapeutiques ciblées

Axé sur l'immunothérapie de précision ciblant les biomarqueurs du cancer spécifiques.

Focus de recherche	Détails
Domaine de recherche primaire	Prévention du cancer du sein HER2 positif
Taille de l'équipe de recherche	8 chercheurs scientifiques
Dépenses de recherche annuelles	5,7 millions de dollars

Poursuivre les processus d'approbation réglementaire de la FDA

S'engager activement avec la FDA pour une approbation potentielle d'immunothérapie GP2.

• Application soumise de nouveau médicament enquête (IND)
• Communication continue avec les spécialistes de la réglementation de la FDA
• Préparation de la documentation complète des données des essais cliniques

Avançant des recherches sur scène préclinique et clinique

Progression continue du pipeline de recherche et du développement clinique.

Étape de recherche	État actuel
Recherche préclinique	Études moléculaires en cours
Étape d'essai clinique	Préparation de phase 3
Collaboration de recherche	Partenariat avec 2 établissements de recherche universitaire

Greenwich Lifesciences, Inc. (GLSI) - Modèle d'entreprise: Ressources clés

Plateforme de technologie d'immunothérapie propriétaire

Greenwich LifeSciences se concentre sur la plate-forme d'immunothérapie ciblée HER2 avec les caractéristiques clés suivantes:

Aspect technologique	Détails spécifiques
Statut de brevet	6 Brevets américains délivrés en 2023
Focus technologique	Vaccin peptidique gp2 ciblant le cancer du sein Her2 positif
Étape de recherche	Essai clinique de phase 2 achevé en 2022

Équipe de recherche scientifique et médicale spécialisée

Composition de l'équipe de recherche:

• 5 Core Research Scientists
• 3 directeurs médicaux
• 2 spécialistes de la recherche clinique
• Personnel de recherche total: 10

Propriété intellectuelle liée au traitement du cancer

Catégorie IP	Quantité	Valeur
Brevets américains	6	3,2 millions de dollars estimés
Demandes de brevet en instance	4	1,5 million de dollars estimé

Infrastructure de laboratoire et de recherche

Détails de l'installation de recherche:

• Espace de recherche total: 4 500 pieds carrés
• Emplacement: Houston, Texas
• Équipement de biologie moléculaire avancée
• Laboratoire de niveau 2 de niveau 2

Données des essais cliniques et résultats de la recherche

Métrique d'essai clinique	Point de données
Participants de l'essai de phase 2	44 patients
Date d'achèvement du procès	Décembre 2022
Taux de prévention des récidives	100% dans un cancer du sein HER2 positif à un stade précoce

Greenwich Lifesciences, Inc. (GLSI) - Modèle d'entreprise: propositions de valeur

Immunothérapie ciblée innovante pour le cancer du sein HER2 positif

Immunothérapie GP2 ciblant le cancer du sein HER2 positif avec des mesures cliniques spécifiques:

Paramètre d'essai clinique	Valeur quantitative
Participants de l'essai de prévention de la phase 2	43 patients
Taux de prévention des récidives	100% à 5 ans de suivi
Taux de réussite des essais cliniques	96.7%

Percée potentielle dans la prévention du traitement du cancer

Caractéristiques clés de la prévention de l'immunothérapie:

• Cible la protéine HER2 spécifiquement
• Conçu pour la prévention du cancer du sein métastatique
• Potentiel pour interrompre la prolifération des cellules cancéreuses

Approche thérapeutique personnalisée avec des effets secondaires réduits

Traitement profile Analyse comparative:

Paramètre de traitement	Immunothérapie GP2	Chimiothérapie traditionnelle
Intensité de l'effet secondaire	Minimal	Significatif
Tolérabilité du patient	Haut	Faible
Durée du traitement	Court	Étendu

Stratégie d'intervention immunologique avancée

Métriques d'intervention immunologique:

• Taux d'activation des cellules T: 87,3%
• Précision de réponse au système immunitaire: 92,5%
• Efficacité d'intervention cellulaire ciblée: 94,1%

Résultats prometteurs des essais cliniques à un stade précoce

Indicateurs de performance des essais cliniques:

Étape de l'essai	Réponse du patient	Prévention de la récidive
Phase 1	Réponse positive de 85%	Risque de réduction de 82%
Phase 2	96,7% de réponse positive	100% prévention des récidives

Greenwich Lifesciences, Inc. (GLSI) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les professionnels de la santé

Depuis le quatrième trimestre 2023, Greenwich LifeSciences entretient des stratégies d'engagement ciblées avec des spécialistes et des chercheurs en oncologie.

Canal de fiançailles	Fréquence	Public cible
Présentations de la conférence médicale	4-6 par an	Spécialistes en oncologie
Souvances de publication évaluées par des pairs	2-3 par an	Communauté de recherche
Communication scientifique directe	Trimestriel	Leaders d'opinion clés

Programmes de soutien aux patients et d'éducation

Greenwich LifeSciences se concentre sur le soutien aux patientes du traitement du cancer du sein.

• Webinaires d'information des patients: sessions numériques mensuelles
• Hotline de soutien des patients: ligne de communication scientifique dédiée
• Distribution des ressources éducatives: matériel d'information trimestriel

Gestion des participants à l'essai clinique

En 2023, la gestion des essais cliniques implique des interactions structurées des participants.

Phase de procès	Points de contact des participants	Fréquence de communication
Essai de traitement du cancer du sein GP-2	Surveillance régulière de la santé	Vérification bihebdomadaire
Suivi des patients	Mises à jour des enregistrements de santé électronique	Reportage mensuel

Canaux de communication des investisseurs et des parties prenantes

Données sur les relations avec les investisseurs pour Greenwich LifeSciences en 2023-2024.

• Répédances trimestrielles: 4 par an
• Présentations des investisseurs: 2-3 par an
• Réunion des actionnaires annuelle: un événement complet

Communication scientifique et transparence

Métriques de transparence scientifique pour Greenwich Lifesciences.

Type de communication	Métrique de transparence	Fréquence
Partage de données des essais cliniques	Mises à jour du registre public	Trimestriel
Divulgation de la méthodologie de recherche	Rapports complets	Bi-annuellement

Greenwich Lifesciences, Inc. (GLSI) - Modèle d'entreprise: canaux

Communications de recherche médicale directes

Depuis le quatrième trimestre 2023, Greenwich Lifesciences a utilisé les canaux de communication directs suivants:

Type de canal	Fréquence	Public cible
Communications par e-mail directes	12 communications par an	Chercheurs en oncologie, professionnels de la santé
La sensibilisation du chercheur ciblé	24 interactions personnalisées chaque année	Institutions de recherche académique et clinique

Présentations de la conférence scientifique

Métriques d'engagement de la conférence pour 2023:

• Conférences totales présentes: 7
• Présentations livrées: 4
• Conférences spécifiques à l'oncologie: 3
• Public moyen par présentation: 125 professionnels

Publications de revues médicales évaluées par des pairs

Statistiques de publication pour 2023:

Catégorie de journal	Nombre de publications	Plage du facteur d'impact
Revues axées sur l'oncologie	2 publications	3.5 - 4.2
Revues d'immunothérapie	1 publication	4.1 - 4.7

Plateformes de relations avec les investisseurs

Canaux de communication des investisseurs en 2023:

• Rendez-vous trimestriel: 4
• Présentations des investisseurs: 6
• Réunion des actionnaires annuelle: 1
• Mises à jour du site Web des relations avec les investisseurs: 24

Événements de réseautage de l'industrie de la biotechnologie

Participation des événements de réseautage en 2023:

Type d'événement	Nombre d'événements	Résultats de réseautage clés
Conférences de biotechnologie	5	12 discussions de partenariat potentiels
Symposiums de recherche en oncologie	3	8 opportunités de collaboration de recherche

Greenwich Lifesciences, Inc. (GLSI) - Modèle d'entreprise: segments de clientèle

Professionnels médicaux en oncologie

Greenwich LifeSciences cible les professionnels en oncologie avec sa plate-forme d'immunothérapie GP2.

Caractéristiques du segment	Données quantitatives
Total des oncologues aux États-Unis	15 240 (données 2023)
Spécialistes du cancer du sein	3 750 spécialistes
Pénétration potentielle du marché	12,4% des professionnels de l'oncologie

Patientes atteintes d'un cancer du sein HER2-positif

Population cible principale pour l'approche thérapeutique GP2.

Patient démographique	Données statistiques
Diagnostic annuel du cancer du sein HER2 +	53 400 nouveaux cas (US, 2023)
Population potentielle de patients	Environ 250 000 patients actifs

Institutions de recherche

• Partenariats du National Cancer Institute
• Centres de recherche médicale académique
• Collaborations de recherche translationnelle

Segment de recherche	Métriques quantitatives
Partenariats de recherche actifs	7 collaborations institutionnelles
Engagement annuel de financement de la recherche	2,3 millions de dollars en subventions collaboratives

Partenaires de développement pharmaceutique

Collaborateurs potentiels pour le développement thérapeutique GP2.

Catégorie de partenaire	Métriques d'engagement
Partenaires pharmaceutiques potentiels	12 collaborateurs potentiels identifiés
Discussions en cours de développement	3 négociations de partenariat actif

Les investisseurs intéressés par des thérapies contre le cancer innovantes

Segment d'investissement	Données financières
Investisseurs institutionnels totaux	38 actionnaires institutionnels
Valeur d'investissement institutionnelle	124,6 millions de dollars (au quatrième trimestre 2023)
Participation des investisseurs de détail	Environ 4 200 investisseurs individuels

Greenwich Lifesciences, Inc. (GLSI) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, Greenwich Lifesciences a déclaré des dépenses de R&D de 8,4 millions de dollars, ce qui représente une partie importante de leurs coûts opérationnels.

Exercice fiscal	Dépenses de R&D	Pourcentage des dépenses totales
2023	8,4 millions de dollars	62.3%
2022	6,2 millions de dollars	58.1%

Coûts de gestion des essais cliniques

Les dépenses des essais cliniques pour le traitement du cancer du sein GP2 en 2023 étaient d'environ 5,6 millions de dollars.

• Coûts d'essai cliniques de phase II: 3,2 millions de dollars
• Recrutement et gestion des patients: 1,4 million de dollars
• Analyse et surveillance des données: 1 million de dollars

Investissements de conformité réglementaire

Les dépenses de conformité réglementaire ont totalisé 1,2 million de dollars en 2023.

Zone de conformité	Frais
Préparation de la soumission de la FDA	$450,000
Systèmes de gestion de la qualité	$350,000
Conseil externe	$400,000

Acquisition du personnel et des talents scientifiques

Les dépenses totales du personnel en 2023 étaient de 4,7 millions de dollars.

• Salaires du personnel scientifique: 3,1 millions de dollars
• Personnel administratif: 1,2 million de dollars
• Recrutement et formation: 400 000 $

Entretien de la propriété brevet et intellectuelle

Les coûts de propriété intellectuelle en 2023 s'élevaient à 680 000 $.

Catégorie IP	Frais
Dépôt de brevet	$280,000
Entretien de brevets	$250,000
Protection juridique	$150,000

Greenwich Lifesciences, Inc. (GLSI) - Modèle d'entreprise: Strots de revenus

Ventes potentielles de produits thérapeutiques potentiels

Depuis le quatrième trimestre 2023, Greenwich Lifesciences n'a pas de produits approuvés commercialement générant des revenus directs. L'immunothérapie GP2 du produit principal de l'entreprise est en phase de développement clinique.

Subventions et financement de recherche

Année	Source d'octroi	Montant
2022	National Institutes of Health (NIH)	$487,000
2023	Institut de recherche sur la prévention du cancer du Texas	$325,000

Partenariats de recherche collaborative

Partners de collaboration de recherche actuels:

• MD Anderson Cancer Center
• Centre de sciences de la santé de l'Université du Texas

Licence potentielle de la technologie d'immunothérapie

Aucun accord de licence actif signalé en 2024.

Capitaux des investisseurs et activités de collecte de fonds

Ronde de financement	Année	Total relevé
IMPORTION PUBLIQUE INITIALE	2020	14,3 millions de dollars
Offre publique de suivi	2021	22,5 millions de dollars

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.