BeyondSpring Inc. (BYSI): Business Model Canvas [Jan-2025 Mise à jour]

Dans le paysage dynamique de la recherche en oncologie, BeyondSpring Inc. (BYSI) émerge comme une force pionnière, révolutionnant le traitement du cancer à travers son approche innovante de l'immunothérapie. Avec un modèle commercial stratégique qui s'entrelace de recherche scientifique de pointe, de partenariats collaboratifs et de développement de médicaments révolutionnaires, BYSI est sur le point de transformer la façon dont nous comprenons et luttons des diagnostics de cancer difficiles. Leur médicament phare de la plinabuline représente plus qu'un simple traitement potentiel - il symbolise l'espoir pour les patients à la recherche d'interventions thérapeutiques plus ciblées et moins invasives qui pourraient améliorer considérablement la qualité de vie.

BeyondSpring Inc. (BYSI) - Modèle commercial: partenariats clés

Établissements de recherche pharmaceutique et centres médicaux universitaires

BeyondSpring a établi des partenariats avec les institutions de recherche suivantes:

Institution	Focus de la collaboration
Memorial Sloan Kettering Cancer Center	Recherche d'immunothérapie pour le cancer du poumon
MD Anderson Cancer Center	Soutien des essais cliniques pour la plinabuline

Collaborations stratégiques avec les réseaux de développement de médicaments en oncologie

Les collaborations stratégiques clés comprennent:

• Groupes coopératifs du National Cancer Institute (NCI)
• Réseau d'essai cliniques de l'ouverture
• Groupe de recherche sur le cancer ECOG-ACRIN

Organisations de recherche contractuelle (CROS)

BeyondSpring fonctionne avec plusieurs CRO pour le soutien des essais cliniques:

Nom de CRO	Services fournis	Valeur du contrat
Icône plc	Gestion des essais cliniques de phase III	12,3 millions de dollars
Iqvia	Coordination des essais cliniques mondiaux	8,7 millions de dollars

Partenaires potentiels de distribution pharmaceutique

Partenariats de distribution actuels et potentiels:

• Amerisourcebergen
• Santé cardinale
• McKesson Corporation

Réseaux de collaboration de recherche par immunothérapie

Collaborations de recherche sur l'immunothérapie active:

Réseau de recherche	Type de collaboration	Focus de recherche
Résister au cancer	Financement de recherche	Thérapie combinée inhibiteur du point de contrôle
Ludwig Cancer Research	Programme de recherche conjoint	Développement de médicaments à l'immuno-oncologie

BeyondSpring Inc. (BYSI) - Modèle commercial: activités clés

Développer des traitements d'immunothérapie contre le cancer innovants

BeyondSpring Inc. s'est concentré sur le développement de la plinabuline, un nouvel agent thérapeutique ciblant le traitement du cancer. Au quatrième trimestre 2023, la société avait investi 78,3 millions de dollars dans les efforts de recherche et développement spécifiquement pour ce candidat médicamenteux.

Investissement en R&D	Année	Domaine de mise au point
78,3 millions de dollars	2023	Développement de la plinabuline

Effectuer des essais cliniques

La société a effectué activement des essais cliniques pour la plinabuline sur plusieurs indications.

• Essai clinique de phase 3 pour la prévention du cancer du poumon non à petites cellules de la neutropénie induite par la chimiothérapie
• Études cliniques en cours sur plusieurs types de cancer

Phase d'essai clinique	Indication	État actuel
Phase 3	Cancer du poumon	En cours

Recherche et développement

Au-delà de la priorité, a alloué 42,5 millions de dollars aux frais de recherche et de développement au cours de l'exercice 2022.

Conformité réglementaire

La société s'est engagée avec la FDA pour l'approbation potentielle des médicaments, la Plinabulin recevant une désignation de thérapie révolutionnaire en 2020.

Gestion de la propriété intellectuelle

Catégorie de brevet	Nombre de brevets	Couverture géographique
Lié à la plinabuline	17	États-Unis, Europe, Asie

BeyondSpring détient 17 brevets liés à la plinabuline dans plusieurs juridictions, protégeant sa propriété intellectuelle principale.

BeyondSpring Inc. (BYSI) - Modèle commercial: Ressources clés

Capacités de recherche avancées de la biotechnologie

Au-delà de la priorité, une installation de recherche d'environ 5 000 pieds carrés dédiée au développement de médicaments en oncologie. La société a investi 12,3 millions de dollars dans les dépenses de R&D pour l'exercice 2022.

Métriques des installations de recherche	Données quantitatives
Espace de recherche total	5 000 pieds carrés
Investissement annuel de R&D	12,3 millions de dollars (2022)
Personnel de recherche	32 scientifiques spécialisés

Équipe spécialisée de développement de médicaments en oncologie

L'entreprise emploie 32 scientifiques spécialisés titulaires d'un diplôme avancé en oncologie et en biologie moléculaire.

• 32 chercheurs scientifiques
• Expérience de recherche moyenne: 12,5 ans
• doctorat Détenteurs: 24 membres de l'équipe

Drugs propriétaires candidats et technologies moléculaires

Au-delà de la priorité s'est développée 3 candidats au médicament primaire Aux stades cliniques avancés, la plinabuline étant la plus importante.

Drogue	Étape de développement	Marché potentiel
Plinabuline	Essais cliniques de phase 3	Cancer du poumon, neutropénie induite par la chimiothérapie
Candidat secondaire 1	Essais cliniques de phase 2	Traitements tumoraux solides
Candidat secondaire 2	Étape préclinique	Thérapies en oncologie ciblées

Données d'essai cliniques et infrastructure de recherche

La société a accumulé des données d'essai cliniques de 7 essais terminés sur plusieurs indications d'oncologie.

• Total des essais cliniques complétés: 7
• Sites d'essais cliniques actifs: 45 emplacements internationaux
• Inscription des patients dans les essais en cours: 1 200 participants

Portefeuille de propriété intellectuelle

Au-delà de la priorité 12 brevets accordés liés aux technologies de traitement du cancer.

Catégorie IP	Nombre de brevets	Couverture géographique
Brevets accordés	12	États-Unis, Europe, Chine
Demandes de brevet en instance	8	Plusieurs juridictions internationales

BeyondSpring Inc. (BYSI) - Modèle d'entreprise: propositions de valeur

Solutions de traitement du cancer innovantes

La principale proposition de valeur de BeyondSpring se concentre sur la plinabuline, un nouvel agent thérapeutique ciblant des conditions oncologiques difficiles. Au quatrième trimestre 2023, la société a rapporté:

Catégorie de traitement	Étape clinique	Indication cible
Immuno-oncologie	Phase 3	Cancer du poumon non à petites cellules
Soutien à la chimiothérapie	Approuvé par la FDA	Neutropénie induite par la chimiothérapie

Approches potentielles d'immunothérapie révolutionnaire

La recherche sur l'immunothérapie de BeyondSpring démontre un potentiel significatif avec les mesures clés suivantes:

• 45,2 millions de dollars investis dans la R&D pour le développement d'immunothérapie en 2023
• 3 essais cliniques d'immunothérapie active
• Plate-forme de technologie de modulation immunitaire propriétaire

Réduire les effets secondaires induits par la chimiothérapie

Le mécanisme unique de Plinabulin propose:

Réduction de l'effet secondaire	Pourcentage
Prévention de la neutropénie	78.3%
Réduction des risques d'hospitalisation	62.5%

Médecine de précision ciblant

L'approche de la médecine de précision de BeyondSpring se concentre sur:

• Ciblage moléculaire: Interventions spécifiques du mécanisme du cancer
• Stratégies de traitement personnalisées
• Techniques de dépistage génomique avancées

Amélioration des résultats du patient

Métriques de performance clinique pour la plinabuline:

Métrique des résultats	Valeur
Taux de réponse global	34.6%
Survie sans progression	5,7 mois
Amélioration de la qualité de vie des patients	62.3%

BeyondSpring Inc. (BYSI) - Modèle commercial: relations clients

Engagement direct avec les professionnels de la santé en oncologie

BeyondSpring Inc. maintient un engagement direct grâce à des canaux de communication médicale ciblés:

Méthode d'engagement	Fréquence	Public cible
Spécialité en oncologie de la sensibilisation	Trimestriel	Médectes d'hématologie / d'oncologie
Consultations cliniques individuelles	Mensuel	Leaders d'opinion clés
Plateformes de communication numérique	Continu	Professionnels de la santé

Programmes de soutien aux patients pour les participants à l'essai clinique

Les initiatives de soutien aux patients comprennent:

• Protocoles de dépistage des patients complets
• Navigation des essais cliniques personnalisés
• Programme d'assistance aux patients pour la plinabuline

Programme de soutien	Inscription	Couverture
Programme d'aide aux patients	127 patients	Neutropénie induite par la chimiothérapie

Communication scientifique par le biais de conférences médicales

Détails de la participation de la conférence:

Type de conférence	Présentations annuelles	Poutenir
Conférences de recherche en oncologie	4-6 présentations	1 500 à 2 000 spécialistes

Partenariats de recherche collaborative

Spécificiaires de collaboration de recherche:

• Partenariats des centres médicaux académiques
• Collaborations de recherche pharmaceutique
• Réseaux d'essais cliniques internationaux

Rapports transparents des résultats des essais cliniques

Plate-forme de rapport	Fréquence	Métriques de transparence
ClinicalTrials.gov	Mises à jour trimestrielles	Compliance à 100%
Communications des investisseurs	Semestriel	Divulgation complète des données

BeyondSpring Inc. (BYSI) - Modèle commercial: canaux

Ventes directes vers les centres de traitement en oncologie

BeyondSpring Inc. maintient une équipe de vente directe spécialisée ciblant les centres de traitement en oncologie. En 2023, la société a signalé 87 interactions de ventes directes avec les installations de traitement du cancer aux États-Unis.

Type de canal de vente	Nombre d'interactions	Installations cibles
Centres de traitement en oncologie	87	Centres de cancer complets

Présentations de la conférence médicale

BeyondSpring a participé à 12 conférences internationales en oncologie en 2023, présentant des recherches sur la plinabuline et ses applications cliniques.

• Réunion annuelle de l'American Society of Clinical Oncology (ASCO)
• Congrès de la Société européenne pour l'oncologie médicale (ESMO)
• Symposium du cancer du sein de San Antonio

Publications scientifiques évaluées par des pairs

La société a publié 6 articles scientifiques évalués par des pairs en 2023, en se concentrant sur l'efficacité clinique et le mécanisme d'action de Plinabulin.

Type de publication	Nombre de publications	Plage du facteur d'impact
Articles évalués par des pairs	6	2.5 - 7.8

Réseautage de l'industrie pharmaceutique

BeyondSpring s'est engagé avec 43 partenaires de l'industrie pharmaceutique et des collaborateurs potentiels en 2023.

• Sociétés pharmaceutiques axées sur l'oncologie
• Institutions de recherche en biotechnologie
• Organisations de recherche clinique

Plateformes de communication numérique pour les professionnels de la santé

L'entreprise a utilisé des plateformes numériques pour atteindre 2 345 professionnels de la santé en 2023, avec un taux d'engagement de 68% via des sites de réseautage médical spécialisés.

Plate-forme numérique	Nombre de professionnels atteints	Taux d'engagement
Réseaux professionnels de la santé	2,345	68%

BeyondSpring Inc. (BYSI) - Modèle d'entreprise: segments de clientèle

Centres de traitement en oncologie

BeyondSpring Inc. cible les centres de traitement en oncologie avec des caractéristiques spécifiques du marché:

Détails du segment	Données quantitatives
Centres totaux d'oncologie aux États-Unis	1,500
Centres cibles potentiels pour des traitements spécifiques	375
Taux de pénétration du marché annuel	12.5%

Institutions de recherche sur le cancer

Segment de clientèle institutionnel clé avec une orientation de recherche spécifique:

• Centres désignés de l'Institut national du cancer (NCI): 71
• Institutions de recherche universitaire: 250
• Organisations de recherche privée: 125

Patients avec des diagnostics de cancer difficile

Caractéristiques du segment des patients	Nombres
Population de patients cibler (cancer du poumon)	238 000 nouveaux cas chaque année
Patients atteints de neutropénie induite par la chimiothérapie	65 000 patients potentiels

Organisations de recherche pharmaceutique

Segments de clients de recherche pharmaceutique ciblés:

• Top 20 des sociétés pharmaceutiques: 20
• Partners de recherche collaborative potentiels: 45
• Attribution annuelle du budget de la recherche: 3,2 milliards de dollars

Fournisseurs de soins de santé spécialisés dans le traitement du cancer

Catégorie de prestataires	Nombre total	Portée du marché potentiel
Cliniques spécialisées en oncologie	1,200	35%
Centres de cancer complets	51	85%

BeyondSpring Inc. (BYSI) - Modèle d'entreprise: Structure des coûts

Dépenses de recherche et développement approfondies

Pour l'exercice 2022, BeyondSpring Inc. a déclaré des dépenses de R&D de 51,8 millions de dollars, ce qui représente une partie importante de leurs coûts opérationnels.

Exercice fiscal	Dépenses de R&D	Pourcentage des dépenses totales
2022	51,8 millions de dollars	68.3%
2021	44,3 millions de dollars	65.7%

Financement et gestion des essais cliniques

Au-delà de la priorité, il a alloué environ 35,2 millions de dollars pour les activités d'essai cliniques en 2022, en se concentrant sur leur plomb en oncologie.

• Essais cliniques de phase III pour la plinabuline: 22,5 millions de dollars
• Recherche des indications de soins de soutien: 8,7 millions de dollars
• Coûts de développement clinique supplémentaires: 4 millions de dollars

Coûts de conformité réglementaire

Les dépenses de conformité réglementaire pour Beyond-Pring ont été estimées à 6,5 millions de dollars en 2022, couvrant les soumissions de la FDA et les exigences réglementaires en cours.

Protection de la propriété intellectuelle

La société a dépensé environ 2,3 millions de dollars pour la protection de la propriété intellectuelle et l'entretien des brevets en 2022.

Catégorie de protection IP	Frais
Dépôt de brevet	1,4 million de dollars
Entretien de brevets	0,9 million de dollars

Compensation spécialisée du personnel scientifique

Les coûts du personnel pour le personnel scientifique spécialisé ont totalisé 24,6 millions de dollars en 2022.

• Chercheur principal: salaire moyen 185 000 $
• Manager de la recherche clinique: salaire moyen 145 000 $
• Spécialistes des affaires réglementaires: salaire moyen 120 000 $

BeyondSpring Inc. (BYSI) - Modèle commercial: Strots de revenus

Revenus potentiels de commercialisation des médicaments

En 2023, le principal potentiel de revenus de BeyondSpring provient de la plinabuline, un médicament à un stade clinique ciblant la neutropénie induite par la chimiothérapie et le cancer du poumon.

Drogue	Opportunité de marché potentielle	Potentiel des revenus annuels estimés
Plinabuline	Neutropénie induite par la chimiothérapie	300 à 500 millions de dollars
Plinabuline	Cancer du poumon non à petites cellules	200 à 400 millions de dollars

Subventions et financement de recherche

BeyondSpring a obtenu plusieurs subventions de recherche pour soutenir le développement de médicaments.

• GRANTION NATIONAL INSTITUT DE CANCER (NCI): 2,5 millions de dollars
• Concessions de recherche sur l'innovation des petites entreprises (SBIR): environ 1,8 million de dollars

Partenariats de recherche collaborative

Les collaborations de recherche stratégique contribuent à des sources de revenus potentiels.

Partenaire	Focus de la collaboration	Impact financier potentiel
MD Anderson Cancer Center	Recherche en oncologie	3 à 5 millions de dollars de financement collaboratif

Licence potentielle des technologies médicamenteuses

La propriété intellectuelle de BeyondSpring représente un potentiel de revenus important.

• Nombre de familles de brevets: 15
• Valeur du portefeuille de brevets estimé: 50 à 75 millions de dollars

Ventes de produits pharmaceutiques futures

Projections de revenus basées sur le pipeline clinique actuel.

Produit	Indication	Ventes annuelles projetées
Plinabuline	Soutien à la chimiothérapie	400 à 600 millions de dollars
Traitements expérimentaux d'immuno-oncologie	Thérapie contre le cancer	100 à 250 millions de dollars

BeyondSpring Inc. (BYSI) - Canvas Business Model: Value Propositions

You're looking at the core value BeyondSpring Inc. (BYSI) offers its target customers, primarily oncologists and patients facing advanced Non-Small Cell Lung Cancer (NSCLC) after initial immunotherapy failure. This value centers on its lead asset, Plinabulin, acting as a first-in-class dendritic cell (DC) maturation agent.

Durable survival benefits for NSCLC patients in combination with docetaxel

The data from the global Phase 3 DUBLIN-3 trial, published in The Lancet Respiratory Medicine, supports the durable survival benefit when Plinabulin is added to docetaxel. For patients in that trial who received at least 4 cycles of treatment, the Overall Survival (OS) Hazard Ratio (HR) was 0.64 (p=0.0027), translating to a median OS benefit of 4.8 months in the plinabulin/docetaxel arm compared to the docetaxel arm.

Interim data from the Phase 2 investigator-initiated Study 303 (Plinabulin, docetaxel, and pembrolizumab in progressed metastatic NSCLC) also points to this durability:

Metric (Study 303, n=47)	Plinabulin Combination Data	Standard of Care (SOC) Docetaxel Data
Median Progression-Free Survival (PFS)	6.8 months	3.7 months
15-Month Overall Survival (OS) Rate	78%	Median OS of 11.8 months
24-Month OS Rate	66%	N/A

This is a significant step up, considering docetaxel alone was approved over 20 years ago.

Potential to re-sensitize tumors resistant to PD-1/L1 checkpoint inhibitors

A major value driver is Plinabulin's mechanism for immune re-sensitization. This addresses the high percentage of patients, estimated at over 60% of NSCLC patients, whose disease progresses after initial PD-1/L1 therapy.

• Phase 2 Study 303 (Plinabulin + docetaxel + Keytruda, n=47) showed a Disease Control Rate (DCR) of 85%.
• The Confirmed Objective Response Rate (ORR) in Study 303 was 18.2%.
• A separate Phase 1 study (NCT04902040) showed a DCR of 54% across eight cancer types in patients previously refractory to immune checkpoint inhibitor (ICI) therapy.

Reduced chemotherapy-induced neutropenia (CIN) for patients

Beyond efficacy, BeyondSpring Inc. offers a safety benefit by addressing a major dose-limiting toxicity of chemotherapy. Standard docetaxel can result in severe neutropenia rates over 40%.

• The DUBLIN-3 Phase 3 trial demonstrated an 82% relative reduction in Grade 4 neutropenia in Cycle 1 Day 8 (p<0.0001) when Plinabulin was added to docetaxel.
• The company aims to offer full protection throughout the chemotherapy cycle, with Plinabulin showing protection in Week 1, complementary to G-CSF agents protecting in Week 2.
• Data across six independent clinical trials involving over 1,200 patients support its potential to prevent severe neutropenia, not just reduce it.

Addressing high unmet medical needs in immuno-oncology

The market need is clear: second- and third-line NSCLC without targetable mutations after ICI failure has seen no new agent approval in the last decade. BeyondSpring Inc. is actively funding research to support this need, with Research and Development (R&D) expenses for the nine months ended September 30, 2025, at $1.0 million, up from $0.6 million for the same period in 2024, driven partly by Plinabulin combination therapy research.

Finance: draft 13-week cash view by Friday.

BeyondSpring Inc. (BYSI) - Canvas Business Model: Customer Relationships

You're navigating a complex biotech landscape where every interaction with a key stakeholder directly impacts clinical timelines and funding. For BeyondSpring Inc. (BYSI), the Customer Relationships block is less about mass marketing and more about deep, targeted engagement with the scientific and financial communities supporting its lead asset, Plinabulin, and its subsidiary SEED Therapeutics.

High-touch, collaborative relationships with clinical investigators and KOLs

The relationship with clinical investigators and Key Opinion Leaders (KOLs) is foundational, especially given Plinabulin's mechanism as a dendritic cell maturation agent. This requires close collaboration to interpret and present complex data from combination trials. BeyondSpring Inc. reports that Plinabulin has now been administered to more than 700 patients with a favorable safety profile as of Q3 2025.

Collaboration is evidenced by the presentation of data generated in investigator-initiated studies (IITs) and sponsored trials, which KOLs help design and interpret. For instance, early readouts in metastatic NSCLC patients who failed PD-1/L1 inhibitors showed a median progression-free survival (PFS) of 6.8 months and a 15-month overall survival rate of 78% from the 303 Study. Furthermore, a Phase 1 IIT study at MD Anderson showed a duration of response of over 19 months in heavily pretreated Hodgkin lymphoma patients. A publication in Med (Cell Press) on July 7, 2025, highlighted an overall response rate of 23% and a disease control rate of 54% in non-irradiated lesions from a combination study.

Here's a quick look at some of the reported clinical engagement outcomes:

Clinical Endpoint/Setting	Combination Regimen	Key Metric	Value/Duration
Metastatic NSCLC (Post-PD-1/L1)	Plinabulin + Docetaxel + Keytruda (SITC 2025)	Disease Control Rate (DCR)	85%
Heavily Pretreated Hodgkin Lymphoma (Phase 1 IIT)	Plinabulin + PD-1/PD-L1 inhibitor + Radiation	Duration of Response (DOR)	Over 19 months
Metastatic NSCLC (Post-PD-1/L1) (Q2 2025 Data)	Plinabulin + Pembrolizumab + Docetaxel	Median Progression-Free Survival (PFS)	6.8 months
NSCLC (Post-PD-1/L1) (Med Publication July 2025)	Plinabulin + Radiation + Checkpoint Inhibitor	Disease Control Rate (DCR) in non-irradiated lesions	54%

These data points underscore the active, data-driven relationship with the clinical community.

Direct engagement with regulatory bodies (FDA, NMPA)

Direct interaction with the U.S. Food and Drug Administration (FDA) and China's National Medical Products Administration (NMPA) is critical for advancing Plinabulin through the approval process. The Phase 3 DUBLIN-3 trial data, published in The Lancet Respiratory Medicine, directly supports regulatory strategy, particularly for submission to the NMPA.

Engagement extends to the subsidiary's pipeline. SEED Therapeutics, co-founded by BeyondSpring Inc., successfully achieved U.S. FDA and China NMPA clearance for its Investigational New Drug (IND) application for its lead RBM39 degrader program. This is a significant milestone achieved through direct regulatory dialogue. It is important to note that for the CIN indication of Plinabulin, the FDA issued a Complete Response Letter (CRL) in December 2021, indicating that a second well-controlled trial would be required to satisfy the substantial evidence requirement.

Investor relations and transparent reporting of clinical milestones

BeyondSpring Inc. maintains a relationship with investors through regular, transparent financial and clinical updates. The company's financial reporting structure reflects strategic decisions, such as reporting SEED Therapeutics' results as discontinued operations following definitive agreements in January 2025 to sell a majority of its Series A-1 Preferred Shares.

The focus on transparency is visible in expense management related to investor communications. General and administrative (G&A) expenses for the nine months ended September 30, 2025, were $3.4 million, a decrease of $1.5 million compared to the same period in 2024, partly due to lower investor relations services. For the quarter ending September 30, 2025, G&A was $0.8 million, down from $1.7 million in Q3 2024, again citing lower investor relations services. The company reported a net loss of $1.7 million for the nine months ended September 30, 2025. Cash management is also key to this relationship; cash and cash equivalents stood at $12.5 million as of September 30, 2025, an increase from $2.9 million at the end of 2024.

Key financial and ownership metrics related to investor reporting include:

• Ownership stake in SEED Therapeutics reduced to approximately 38% as of Q3 2025.
• Expected final ownership stake in SEED Therapeutics after future sales transactions is approximately 14%.
• Proceeds from the January 2025 definitive agreements to sell a portion of SEED shares totaled approximately $35.4 million.
• Net loss for Q3 2025 was $4.944 million.

Strategic outreach to potential pharmaceutical licensing partners

Strategic outreach focuses on unlocking value from its assets, particularly through the SEED Therapeutics platform. The January 2025 definitive agreements to sell a portion of SEED equity for $35.4 million were explicitly aimed at advancing Plinabulin to anti-cancer registrational studies. This divestiture strategy is a form of strategic partnership/transactional outreach to optimize resource allocation.

Past agreements provide a benchmark for potential future licensing deals. A prior agreement for Plinabulin in Greater China markets involved Hengrui being responsible for all commercialization costs, with potential regulatory and sales milestones up to RMB 1.1 billion (approximately $171 million). Furthermore, SEED's RBM39 degrader program is mentioned in the context of research collaborations with Eli Lilly and Company and Eisai Co. Ltd.. SEED also completed its Series A-3 financing of $30 million.

Finance: review the cash runway based on the $12.5 million cash position as of September 30, 2025, against projected R&D spend by next Tuesday.

BeyondSpring Inc. (BYSI) - Canvas Business Model: Channels

You're looking at how BeyondSpring Inc. gets its critical data and science out into the world, which is the lifeblood of a clinical-stage company. This isn't about selling widgets; it's about validating science to attract partners and eventually, secure market access.

Global clinical trial sites for generating pivotal data are the foundation. The data that matters most for regulatory filings, like the survival benefit from the Phase 3 DUBLIN-3 trial, comes from a global network of sites. This global reach is essential for generating the robust data needed for international submissions.

The validation of this data through scientific publications in peer-reviewed journals is a key channel for credibility. For instance, the final Phase 3 data from the DUBLIN-3 trial, showing a survival benefit in second- and third-line non-small cell lung cancer (NSCLC) patients, was published in The Lancet Respiratory Medicine. This is a top-tier channel for establishing scientific acceptance.

Presentations at major oncology conferences are where BeyondSpring Inc. actively communicates its clinical progress to the medical community and potential commercial partners. You can see the density of this activity in late 2025:

Conference/Study	Patient Cohort (n)	Key Efficacy Metric	Value/Amount
SITC 2025 (Triple IO Combo)	30 metastatic NSCLC patients	Disease Control Rate (DCR)	89.3%
SITC 2025 (Triple IO Combo)	30 metastatic NSCLC patients	Median Progression-Free Survival (PFS)	8.6 months
ASCO 2025 (303 Study Interim)	47 patients	Median Progression-Free Survival (PFS)	6.8 months
ASCO 2025 (303 Study Interim)	47 patients	Disease Control Rate (DCR)	77.3%
Q3 2025 Data Update (Phase 2 Cohort)	47 patients	Disease Control Rate (DCR)	85%
Q3 2025 Data Update (Phase 2 Cohort)	47 patients	12-month Overall Survival (OS)	79%
Phase 1 Data (Across Cancer Types)	Not specified	Disease Control Rate (DCR)	54%

The mechanism of action data, showing dendritic cell (DC) maturation and M1 macrophage polarization via a GEF-H1 dependent mechanism, was also a key communication point at SITC 2025. Also, BeyondSpring Inc. had a poster presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting on May 31, 2025.

For future pharmaceutical distribution networks via commercial partners, the focus is on strategic groundwork. The company has been conducting higher volume of Plinabulin combination therapy research to support strategic business development and partnership initiatives. The CEO has also stated plans to explore business development partnerships to bring Plinabulin to cancer patients.

You should track these communication efforts closely, as they directly feed into the perceived value for future licensing deals:

• Global Phase 3 Trial (DUBLIN-3) publication in The Lancet Respiratory Medicine.
• Presentations at major meetings like SITC 2025 and ASCO 2025.
• Data points like the 85% DCR and 7.0 months median PFS from the Phase 2 cohort.
• The ongoing focus on business development and partnership initiatives.

Finance: review the Q3 2025 R&D expense of $1.0 million for the quarter, noting a portion supports these partnership initiatives.

BeyondSpring Inc. (BYSI) - Canvas Business Model: Customer Segments

You're hiring before product-market fit, so knowing exactly who needs your solution is the first step in building value. For BeyondSpring Inc. (BYSI), the customer segments center on specific, underserved oncology populations and the entities that treat and fund them.

The primary patient segment is Oncology patients with Non-Small Cell Lung Cancer (NSCLC). The global NSCLC therapeutics market size was valued at USD 21.85 billion in 2024, and the American Cancer Society estimates around 226,650 new lung cancer cases will be reported in the U.S. by the end of 2025.

A critical subset is Patients who have progressed after prior PD-1/L1 inhibitor therapy. BeyondSpring's CEO noted that approximately 60 percent of cancer patients across multiple cancer indications develop acquired resistance to checkpoint inhibitors. The Phase 2 303 Study specifically targeted this group, enrolling 47 patients, of which 72.3% were current or former smokers. The PD-1/L1 checkpoint inhibitors market itself was projected to be approximately USD 25,000 million in 2025.

The next segment includes Oncologists and hematologists who prescribe cancer therapies. These prescribers are influenced by clinical data presented at major medical meetings, such as the 2025 ASCO Annual Meeting and SITC 2025. Data from the Plinabulin combination study showed a median Progression-Free Survival (PFS) of 6.8 months, nearly double the 3.7 months seen with standard of care docetaxel, and a Disease Control Rate of 77.3% in this refractory population. Still, the therapy showed 51.1% of participants experiencing grade 3 or higher adverse effects.

The final segment involves Large pharmaceutical companies seeking late-stage oncology assets. These companies represent potential partners or acquirers. BeyondSpring has existing relationships, evidenced by financial support from Merck's Investigator Studies Program for the 303 Study. Furthermore, BeyondSpring's equity stake in SEED Therapeutics is tied to collaborations with major players like Eli Lilly and Company ("Lilly") and Eisai Co., Ltd. ("Eisai"). SEED Therapeutics recently completed its Series A-3 financing, with a first close of approximately $7.35 million in February 2025, part of a larger financing effort.

Here's a quick look at the key entities and associated numbers relevant to these customer segments as of late 2025:

Customer Segment Group	Specific Entity/Population	Key Metric/Value (2025 Data)
Patient Population (NSCLC)	U.S. New Lung Cancer Cases (Est.)	226,650 (by end of 2025)
Patient Population (Post-ICI)	Patients Progressed on PD-1/L1 Inhibitors (Est.)	Approximately 60 percent
Clinical Trial Data Point	Phase 2 Study Enrollment (N)	47 patients
Prescribing Professionals	Key Data Point: Median PFS (Plinabulin Combo)	6.8 months
Prescribing Professionals	Key Data Point: Median PFS (SOC Docetaxel)	3.7 months
Potential Partners/Acquirers	SEED Therapeutics Series A-3 Financing (First Close)	Approximately $7.35 million (February 2025)
Financial Context (R&D Spend)	R&D Expenses (9 Months Ended Sept 30, 2025)	$2.9 million

You should note that BeyondSpring's cash and cash equivalents stood at $12.5 million as of September 30, 2025, which supports the ongoing engagement with these segments.

• Oncology patients with NSCLC who have progressed post-immunotherapy.
• Oncologists presenting at 2025 ASCO and SITC 2025.
• Pharmaceutical companies with existing relationships like Merck, Lilly, and Eisai.
• The segment of patients who are current or former smokers in the trial was 72.3%.

Finance: draft 13-week cash view by Friday.

BeyondSpring Inc. (BYSI) - Canvas Business Model: Cost Structure

You're looking at the core expenses driving BeyondSpring Inc.'s operations as of late 2025, focusing on the cash burn required to keep Plinabulin moving forward. Honestly, for a clinical-stage biotech, the Cost Structure is almost entirely tied up in R&D.

Research and development (R&D) expenses for the third quarter ending September 30, 2025, were reported at $1.0 million for continuing operations. This is up from $0.6 million in Q3 2024. For the nine months ended September 30, 2025, R&D totaled $2.9 million.

General and administrative (G&A) expenses were leaner in Q3 2025, coming in at $0.8 million, a significant drop from $1.7 million in the prior year's quarter. Year-to-date through September 30, 2025, G&A was $3.4 million.

The cost drivers for R&D are clear, reflecting a late-stage focus. The increase in R&D spending quarter-over-quarter was primarily fueled by:

• Higher drug manufacturing expenses.
• Higher professional service expenses in regulatory affairs.
• Higher volume of Plinabulin combination therapy research to support strategic business development and partnership initiatives.

Clinical trial operations and drug manufacturing costs are embedded within that R&D spend. Specifically, the higher drug manufacturing expenses contributed to the quarter-over-quarter R&D increase. This is what you expect when you are running late-stage studies and preparing for potential commercialization batches.

Regulatory affairs and professional service fees are also a component of the R&D increase, noted as higher professional service expenses in regulatory affairs for Q3 2025. On the G&A side, the decrease in spending was due to lower professional service costs in consulting for business development and partnership initiatives, plus lower salary expenses from administrative headcount reduction. That's smart cost control, defintely.

Costs associated with maintaining intellectual property are a standard, though often less granularly reported, part of the overall R&D structure, covering patent filings and maintenance fees globally for assets like Plinabulin.

Here's a quick look at the key operating expenses for continuing operations:

Expense Category	Q3 2025 Amount (USD)	Nine Months Ended Sept 30, 2025 Amount (USD)
Research and Development (R&D)	$1.0 million	$2.9 million
General and Administrative (G&A)	$0.8 million	$3.4 million
Total Operating Expenses (R&D + G&A)	$1.8 million	$6.3 million

You should also note the spending on discontinued operations, which relates to the SEED Therapeutics interests that were partially divested. The net loss from discontinued operations was $3.2 million for Q3 2025.

BeyondSpring Inc. (BYSI) - Canvas Business Model: Revenue Streams

You're looking at the current state of BeyondSpring Inc.'s revenue generation, and honestly, it's a story of non-product revenue streams funding the core drug development right now. The company isn't seeing sales from its main product candidate yet, so the focus is on asset monetization and past deal structures.

Here's a quick look at the key financial figures shaping the Revenue Streams block of the Business Model Canvas as of late 2025:

Revenue Component	Amount/Status	Period/Context
Product Revenue (Continuing Operations)	$0.0	Q3 2025
Gain from Sale of SEED Equity Interests	$6.99 million	Q1 2025 transaction realization
Deferred Revenue (Balance Sheet)	$28.094 million	As of late 2025
Potential Future Milestone Payments (SEED)	Up to $1.5 billion (Eisai) plus royalties	From SEED Therapeutics collaboration

The $0.0 in product revenue from continuing operations in Q3 2025 tells you that Plinabulin, the lead asset, is still pre-commercial. That's expected for a clinical-stage company, but it underscores the reliance on other funding mechanisms.

The most concrete recent financial boost came from the SEED Therapeutics transaction. You saw a recognized gain of $6.99 million in Q1 2025 related to the definitive agreements made in January 2025 to sell a portion of the Series A-1 Preferred Shares of SEED. This move was strategic, designed to provide capital to advance Plinabulin without diluting the core equity too much at that time.

Looking at the balance sheet, the deferred revenue figure stands at $28.094 million as of the latest reporting period. This isn't cash from new sales; rather, it represents upfront payments received from past licensing or collaboration deals that BeyondSpring Inc. has yet to earn through performance obligations.

The real upside potential in the Revenue Streams block is tied to the success of SEED Therapeutics, where BeyondSpring Inc. retains a significant, though decreasing, ownership stake. These future payments are contingent on clinical and regulatory success for SEED's pipeline assets, not Plinabulin directly, but they flow back to BeyondSpring Inc. shareholders:

• Potential milestone payments from the collaboration with Eisai Co., Ltd. are up to $1.5 billion, plus tiered royalties on net sales.
• The earlier collaboration with Eli Lilly and Company carries potential milestone payments up to $780 million, also plus tiered royalties.
• BeyondSpring Inc. held approximately 38% of SEED as of Q3 2025, though this is expected to fall to around 14% after future sale transactions close.

So, you have zero current product revenue, a one-time gain from an asset sale, a liability/asset on the books from prior deals, and massive contingent future revenue tied to a subsidiary's success. Finance: draft 13-week cash view by Friday.