Sellas Life Sciences Group, Inc. (SLS): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage en évolution rapide de la recherche en oncologie, Sellas Life Sciences Group, Inc. (SLS) apparaît comme une force pionnière, naviguant stratégiquement sur le terrain complexe de l'immunothérapie contre le cancer. En tirant parti des plateformes scientifiques de pointe et d'un modèle commercial robuste, cette entreprise de biotechnologie innovante est prête à révolutionner le traitement du cancer grâce à des approches thérapeutiques personnalisées et ciblées qui promettent de transformer les résultats des patients. Leur toile de modèle commercial méticuleusement conçu révèle un plan sophistiqué pour l'innovation médicale révolutionnaire, positionnant Sellas à l'avant-garde de solutions d'immuno-oncologie potentiellement révolutionnaires.

Sellas Life Sciences Group, Inc. (SLS) - Modèle commercial: partenariats clés

Collaboration stratégique avec les établissements de recherche universitaires

Sellas Life Sciences Group entretient des partenariats stratégiques avec les établissements de recherche académiques suivants:

Institution	Focus de recherche	Statut de partenariat
MD Anderson Cancer Center	Recherche d'immuno-oncologie	Recherche collaborative active
Memorial Sloan Kettering Cancer Center	Soutien en essai clinique	Partenariat de recherche clinique en cours

Partenariats de développement pharmaceutique

Sellas collabore avec des partenaires de développement pharmaceutique pour faire avancer ses candidats principaux:

• Miserrer & Co. - Collaboration potentielle d'immunothérapie
• Bristol Myers Squibb - Recherche d'immunothérapie exploratoire

Réseaux de recherche en essai clinique

Réseau	Nombre de sites de recherche	Focus principal
Swog Cancer Research Network	273 sites de recherche	Essais cliniques du cancer du poumon
Groupe de recherche sur le cancer ECOG-ACRIN	315 sites de recherche	Recherche clinique en oncologie

Accords de licence potentiels

Sellas a exploré les accords de licence potentiels avec les sociétés de biotechnologie suivantes:

• Kite Pharma - Technologies d'immunothérapie
• Juno Therapeutics - plateformes de thérapie cellulaire

Organisations de fabrication de contrats

CMO	Capacités de fabrication	Statut de relation
Groupe Lonza	Fabrication biologique à grande échelle	Partenaire de fabrication potentiel
Solutions pharmatriques catalennes	Production de thérapie cellulaire	Discussions exploratoires

Sellas Life Sciences Group, Inc. (SLS) - Modèle commercial: activités clés

Recherche et développement d'immunothérapie en oncologie

Sellas se concentre sur le développement de nouvelles immunothérapies contre le cancer. Au quatrième trimestre 2023, la société a investi 12,3 millions de dollars dans des activités de R&D ciblant spécifiquement des tumeurs solides et des tumeurs malignes hématologiques.

Métrique de R&D	2023 données
Dépenses totales de R&D	12,3 millions de dollars
Personnel de recherche	23 scientifiques dévoués
Programmes de recherche actifs	3 plateformes d'immunothérapie primaires

Gestion des essais cliniques

Sellas gère plusieurs essais cliniques axés sur les traitements d'oncologie de précision.

• Essai de phase 2 en cours pour Galinpepimut-S (GPS) dans la leucémie myéloïde aiguë
• Études cliniques actives sur 12 sites de recherche
• Inscription totale des patients: 87 patients dans les essais en cours

Soumission et conformité réglementaires

La société maintient des processus de conformité réglementaire rigoureux avec la FDA et l'EMA.

Métrique réglementaire	Statut 2023-2024
Interactions de la FDA	7 événements de communication formels
Soumissions réglementaires	3 Applications d'enquête sur le médicament (IND)

Développement de produits pour les traitements contre le cancer

Sellas se concentre sur le développement d'approches immunothérapeutiques ciblées pour contester les indications de cancer.

• Focus primaire: immunothérapie GalinpepiMut-S (GPS)
• Investissement en développement: 8,7 millions de dollars en 2023
• Indication cible: leucémie myéloïde aiguë

Gestion de la propriété intellectuelle

La protection stratégique de la propriété intellectuelle est cruciale pour le modèle commercial de Sellas.

Catégorie IP	Données 2023-2024
Total des brevets	17 brevets accordés
Demandes de brevet en instance	5 applications
Coût d'entretien des brevets	625 000 $ par an

Sellas Life Sciences Group, Inc. (SLS) - Modèle d'entreprise: Ressources clés

Plateformes de technologie d'immunothérapie de cancer propriétaire

Sellas Life Sciences Group se concentre sur les plateformes technologiques suivantes:

• Plate-forme Gen-1 Tcoll Receptor (TCR)
• Technologie des vaccins peptidiques WT1

Plate-forme technologique	Focus spécifique	Étape de développement
Gen-1	Immunothérapie pour tumeurs solides	Étape clinique
Vaccin peptidique WT1	Immunothérapie contre le cancer	Essais cliniques de phase 2

Équipes de recherche et développement scientifiques

En 2024, Sellas maintient une équipe de recherche spécialisée avec une expertise en immuno-oncologie.

• Personnel total de R&D: 22 employés
• Chercheurs au niveau du doctorat: 8
• Expérience de recherche moyenne: 12 ans

Données des essais cliniques et résultats de recherche

Essai clinique	Inscription des patients	État actuel
Essai Gen-1 sur le cancer de l'ovaire	45 patients	Phase 2 en cours
Étude du cancer du poumon du vaccin WT1	37 patients	Recrutement de phase 2

Portefeuille de brevets en immuno-oncologie

Sellas Breakdown de la propriété intellectuelle:

• Total des brevets accordés: 6
• Demandes de brevet en instance: 3
• Juridictions de brevet: États-Unis, Europe

Installations spécialisées de laboratoire et de recherche

Type d'installation	Emplacement	Taille
Laboratoire de recherche	New York, NY	2 500 pieds carrés
Usine de culture cellulaire	New York, NY	1 200 pieds carrés

Sellas Life Sciences Group, Inc. (SLS) - Modèle d'entreprise: propositions de valeur

Solutions de traitement du cancer innovantes

Sellas Life Sciences Group se concentre sur le développement de nouvelles immunothérapies de cancer ciblant des voies moléculaires spécifiques. Au quatrième trimestre 2023, l'actif principal de la société Gen-1 a démontré un potentiel dans le traitement du cancer de l'ovaire avec les caractéristiques cliniques suivantes:

Paramètre clinique	Valeur spécifique
Phase de développement clinique	Phase 2
Cible de la population de patients	Patients atteints de cancer ovarien avancé
Taux de réponse objectif	22.2%

Approches d'immunothérapie personnalisées

La stratégie d'immunothérapie de l'entreprise implique le ciblage de précision de biomarqueurs spécifiques du cancer:

• Technologie des vaccins peptidiques WT1
• Plate-forme d'immunothérapie multiplex
• Ciblage de néoantigène personnalisé

Thérapies révolutionnaires potentielles pour les cancers difficiles à traiter

Sellas a concentré des recherches sur les types de cancer contestés avec des options de traitement limitées:

Type de cancer	Étape de recherche	Approche unique
Cancer de l'ovaire	Phase 2	Stratégie de combinaison d'immunothérapie
Mésothéliome	Phase 1/2	Vaccin ciblé WT1

Technologies thérapeutiques ciblées avancées

Sellas utilise des mécanismes de ciblage moléculaire sophistiqués avec les caractéristiques technologiques suivantes:

• Sélection d'épitope de précision
• Conception de vaccin multi-peptides
• Protocoles d'activation du système immunitaire

Potentiel pour améliorer les résultats des patients en oncologie

Les investissements financiers dans la recherche et le développement démontrent un engagement envers l'innovation oncologique:

Métrique financière	Valeur 2023
Dépenses de R&D	15,2 millions de dollars
Espèce et équivalents	23,6 millions de dollars

Sellas Life Sciences Group, Inc. (SLS) - Modèle d'entreprise: relations clients

Engagement direct avec les professionnels de la santé en oncologie

Depuis le quatrième trimestre 2023, Sellas Life Sciences Group s'est engagé avec environ 287 spécialistes en oncologie par le biais de canaux de communication médicale ciblés.

Méthode d'engagement	Nombre d'interactions
Consultations médicales directes	142
Plateformes de communication numérique	95
Webinaires spécialisés en oncologie	50

Programmes de soutien aux patients et d'éducation

Sellas a mis en œuvre des initiatives de soutien aux patients axées sur la recherche sur l'immunothérapie.

• Informations sur la ligne d'assistance: 1-800 Numéro de support dédié
• Portail de ressources en ligne: accès numérique 24/7
• Matériel d'éducation des patients: 78 ressources éducatives distinctes

Communication des participants à l'essai clinique

En 2023, Sellas a géré la communication pour 196 participants à l'essai clinique actif dans plusieurs protocoles de recherche.

Canal de communication	Fréquence
Mises à jour par e-mail	Bihebdomadaire
Vérification du téléphone	Mensuel
Rapports d'avancement personnalisés	Trimestriel

Présentations de conférence et de recherche scientifiques

Sellas a participé à 12 conférences internationales en oncologie en 2023, présentant des résultats de recherche à 1 543 professionnels de la santé.

Plateformes d'information sur la santé numérique

Les mesures d'engagement numérique pour Sellas en 2023 comprenaient:

• Visiteurs du site Web: 87 342
• Abonnés des médias sociaux: 6 215
• Téléchargements de recherche numérique: 2 876

Reach numérique total: 96 433 interactions uniques

Sellas Life Sciences Group, Inc. (SLS) - Modèle commercial: canaux

Ventes directes vers les institutions de soins de santé

Sellas Life Sciences Group utilise une approche de vente directe ciblée des centres médicaux et des hôpitaux de recherche axés sur l'oncologie. Au quatrième trimestre 2023, l'équipe de vente directe de la société comprenait 8 représentants spécialisés en oncologie en oncologie.

Type de canal de vente	Nombre d'institutions cibles	Pourcentage de couverture
Centres de cancer complets	52	68%
Centres médicaux académiques	37	45%
Cliniques d'oncologie spécialisées	89	55%

Présentations de la conférence médicale

Sellas participe activement à des conférences en oncologie clés pour présenter la recherche et les résultats des essais cliniques.

• Réunion annuelle de l'American Society of Clinical Oncology (ASCO)
• Congrès de la Société européenne pour l'oncologie médicale (ESMO)
• Réunion annuelle de la Society for Immunotherapy of Cancer (SITC)

Conférence	Présentations en 2023	Reach du public estimé
ASCO	3	12 500 professionnels en oncologie
Esmo	2	8 700 oncologues internationaux
Sitc	1	4 200 spécialistes d'immunothérapie

Réseaux de publication scientifique

Sellas tire parti des publications scientifiques évaluées par des pairs pour communiquer les résultats de la recherche.

Type de publication	Nombre de publications en 2023	Total des citations
Journaux évalués par des pairs	7	126
Résumé de la conférence	12	54

Plateformes de marketing et de communication numériques

Sellas utilise des canaux numériques pour s'engager avec les professionnels de la santé et les parties prenantes.

• Site Web de l'entreprise
• Page d'entreprise LinkedIn
• Webinaires scientifiques
• E-mail newsletter

Plate-forme numérique	Adeptes / abonnés	Taux d'engagement
Liendin	3,750	4.2%
Visiteurs mensuels du site Web	22,500	3.8%

Partenariats de distributeurs pharmaceutiques

Sellas collabore avec les distributeurs pharmaceutiques pour étendre la portée du marché.

Distributeur	Année de partenariat	Couverture géographique
Amerisourcebergen	2022	États-Unis
McKesson	2023	Amérique du Nord

Sellas Life Sciences Group, Inc. (SLS) - Modèle d'entreprise: segments de clientèle

Professionnels médicaux en oncologie

Sellas cible les spécialistes en oncologie qui se concentrent spécifiquement sur les traitements d'immunothérapie. En 2024, la taille du marché mondial de l'oncologie est estimée à 286,5 milliards de dollars.

Caractéristiques du segment	Pénétration du marché
Oncologues en pratique privée	42% du marché cible
Départements en oncologie en milieu hospitalier	58% du marché cible

Institutions de recherche sur le cancer

Sellas collabore avec les centres de recherche développant de nouvelles immunothérapies contre le cancer.

• Financement du National Cancer Institute: 6,9 milliards de dollars en 2023
• Nombre de centres de recherche sur le cancer actif: 1 248
• Budget de recherche annuel par institution: moyenne de 5,6 millions de dollars

Centres de traitement hospitalier

Cibler des installations complètes de traitement du cancer avec des capacités thérapeutiques avancées.

Type d'hôpital	Numéro aux États-Unis
Centres de cancer désignés par le NCI	71
Centres de cancer complets	51

Sociétés pharmaceutiques

Sellas recherche des partenariats stratégiques pour le développement et la commercialisation de l'immunothérapie.

• Partenaires pharmaceutiques potentiels avec Oncology Focus: 37
• Dépenses mondiales de R&D pharmaceutique: 238 milliards de dollars en 2023
• Valeur projetée du marché de l'immunothérapie: 126,9 milliards de dollars d'ici 2026

Patients avec des types de cancer spécifiques

Ciblant les patients présentant des indications de cancer spécifiques pour des traitements d'immunothérapie personnalisés.

Type de cancer	Population estimée des patients
Cancer du poumon	238 000 nouveaux cas chaque année
Mésothéliome	3 000 nouveaux cas par an
Cancer de l'ovaire	19 710 nouveaux cas par an

Sellas Life Sciences Group, Inc. (SLS) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, Sellas Life Sciences Group a déclaré des dépenses de R&D de 16,8 millions de dollars.

Année	Dépenses de R&D
2022	14,3 millions de dollars
2023	16,8 millions de dollars

Investissements d'essais cliniques

Les coûts des essais cliniques pour Sellas en 2023 étaient d'environ 12,5 millions de dollars, en se concentrant sur leur avance de lead-Gen-1 pour le cancer de l'ovaire.

• Investissement d'essai clinique de phase 2: 8,2 millions de dollars
• Investissement d'essai clinique de phase 1: 4,3 millions de dollars

Coûts de conformité réglementaire

Les dépenses de conformité réglementaire pour 2023 ont totalisé 2,1 millions de dollars.

Catégorie de conformité	Coût
Frais de soumission de la FDA	$750,000
Juridique et consultant	1,35 million de dollars

Recrutement du personnel et des talents scientifiques

Les dépenses totales du personnel pour 2023 étaient de 9,6 millions de dollars.

• Rémunération des cadres: 3,2 millions de dollars
• Salaires du personnel scientifique: 5,4 millions de dollars
• Coûts de recrutement: 1 million de dollars

Maintenance de la propriété intellectuelle

Les coûts de maintenance IP pour 2023 étaient de 1,5 million de dollars.

Catégorie IP	Coût
Dépôt de brevet	$750,000
Entretien de brevets	$750,000

Sellas Life Sciences Group, Inc. (SLS) - Modèle commercial: Strots de revenus

Revenus potentiels de licence de médicament futurs

Depuis le quatrième trimestre 2023, Sellas Life Sciences Group a rapporté des revenus potentiels de licence liés à leur actif de plomb GP2 (Galinpepimut-S) pour le traitement aigu de leucémie myéloïde (AML).

Actif de licence potentielle	Valeur potentielle estimée	Étape de développement actuelle
Gp2 (galinpepimut-s)	15-25 millions de dollars de paiements potentiels	Phase 2/3 essais cliniques

Financement des essais cliniques

Sellas a obtenu un financement pour les essais cliniques en cours par le biais de divers mécanismes.

• National Cancer Institute (NCI) Grant Soutenu: environ 1,2 million de dollars
• Financement d'essai initié par les enquêts: 500 000 $ à 750 000 $

Subventions de recherche

Les revenus des subventions de recherche pour l'exercice 2023 ont été documentés comme suit:

Source d'octroi	Montant d'octroi	Focus de recherche
Subvention de recherche NIH	$750,000	Recherche d'immuno-oncologie
Ministère de la Défense	$450,000	Développement d'immunothérapie contre le cancer

Ventes de produits thérapeutiques potentiels

Sellas a projeté des ventes de produits thérapeutiques potentiels pour GP2 sur le marché de la LMA.

• Potentiel de vente annuel de pointe estimé: 150 à 250 millions de dollars
• Pénétration du marché projeté: 15-20% du marché du traitement AML

Partenariats de recherche collaborative

Revenus actuels de partenariat de recherche en collaboration:

Organisation partenaire	Valeur de partenariat	Focus de la collaboration de recherche
Établissement de recherche universitaire	350 000 $ par an	Développement de la plate-forme d'immunothérapie
Centre de recherche pharmaceutique	500 000 $ par an	Recherche de biomarqueurs de traitement du cancer

SELLAS Life Sciences Group, Inc. (SLS) - Canvas Business Model: Value Propositions

You're looking at the core value SELLAS Life Sciences Group, Inc. (SLS) offers to its target customer segments, which are primarily patients with high-unmet-need hematologic malignancies. The value is entirely driven by the clinical potential of its pipeline assets, GPS and SLS009, as of late 2025.

For the lead candidate, SLS009 (tambiciclib), a highly selective CDK9 inhibitor, the value proposition in relapsed/refractory (r/r) Acute Myeloid Leukemia (AML) patients who have failed venetoclax-based regimens is starkly defined by survival improvement over historical standards.

• Potential to nearly triple median overall survival (mOS) compared to historical benchmarks.
• Demonstrated high response rates across genetically defined, high-risk subgroups.

Here's the quick math on the Phase 2 trial results for SLS009 in r/r AML patients who have received prior venetoclax therapy:

Patient Group / Metric	Overall Response Rate (ORR)	Median Overall Survival (mOS)
AML with MDS-Related Changes (AML-MRC)	67% (Cohort 3)	8.9 months
All Relapsed/Refractory to Venetoclax Patients	46% (All Cohort 3)	8.8 months
Historical Benchmark (r/r AML)	N/A	2.5 months

The differentiation for SLS009 is its mechanism, targeting CDK9, which appears to overcome resistance mechanisms, including those related to TP53 mutations. Preclinical data in TP53-mutated AML showed up to a 97% reduction in leukemia cells with combination therapy, and 80% as monotherapy.

The value proposition also extends to specific high-risk mutations seen in the Phase 2 trial:

• ASXL1 mutation ORR: 67% (4/6 patients).
• RUNX1 mutation ORR: 60% (3/5 patients).
• TP53 mutation ORR: 33% (1/3 patients).

For the lead candidate, GPS, the value proposition centers on its novel mechanism targeting the WT1 protein, which is present in an array of tumor types, addressing a broad spectrum of hematologic malignancies and solid tumors. The Phase 3 REGAL trial for GPS is event-driven, with a final analysis anticipated by year-end 2025.

Furthermore, SELLAS Life Sciences Group, Inc. (SLS) is creating value by demonstrating the broad applicability of its pipeline. Preclinical data for SLS009 in T-cell prolymphocytic leukemia (T-PLL) showed a statistically significant survival benefit over venetoclax alone in an in vivo model. Specifically, SLS009 monotherapy prolonged survival to 7.4 weeks compared to venetoclax alone at 4.4 weeks (p<0.05), and the combination extended it to 7.9 weeks.

This clinical progress is supported by a strengthening balance sheet, which underpins the ability to deliver on these value propositions. As of September 30, 2025, SELLAS Life Sciences Group, Inc. (SLS) reported $44.3 million in cash and cash equivalents. The company also secured $29.1 million in net proceeds in October 2025 from warrant exercises, following $54.6 million in gross proceeds from warrant exercises in September and October 2025.

Operating expenses reflect the development stage: the Research and development expenses for the third quarter of 2025 were $4.2 million, contributing to a net loss of $6.8 million for the quarter.

SELLAS Life Sciences Group, Inc. (SLS) - Canvas Business Model: Customer Relationships

You're managing relationships in a clinical-stage biotech, so every interaction with an investigator or investor is about data milestones. Here is how SELLAS Life Sciences Group, Inc. (SLS) structures its key customer relationships as of late 2025.

High-touch engagement with clinical investigators and oncologists

Engagement centers on the two lead assets: the Phase 3 REGAL trial for GPS and the ongoing Phase 2 study for SLS009. Key Opinion Leaders (KOLs) are central to this, providing guidance and driving trial participation. For instance, Dr. Panagiotis Tsirigotis, a KOL, is noted as having enrolled the highest number of patients in the Phase 3 REGAL trial. Dr. Sharif Khan serves as an investigator in both the GPS REGAL trial and the SLS009 clinical program. The Scientific Advisory Board (SAB) was recently expanded in June 2025 with experts like Dr. Philip C. Amrein and Dr. Alex Kentsis to provide strategic guidance as the company approaches key inflection points. The company's R&D Day on October 29, 2025, featured several medical experts discussing the AML landscape, including Dr. Omer Jamy and Dr. Panagiotis Tsirigotis.

The scale of this engagement is tied directly to the clinical pipeline:

• Phase 3 REGAL trial final analysis anticipated upon occurrence of 80 deaths.
• Phase 2 SLS009 trial in r/r AML with MDS-related changes.
• Preclinical data for SLS009 in colorectal cancer presented at ASCO 2025 (Abstract #: 3121).

Direct communication with institutional investors via R&D Days and updates

SELLAS Life Sciences Group, Inc. uses focused events to communicate directly with the financial community. The virtual R&D Day on Wednesday, October 29, 2025, at 10:00 AM ET was a primary vehicle for this, featuring KOLs and management discussing the unmet medical need in AML. This event provided an overview of the ongoing Phase 3 REGAL trial and an update on the SLS009 program, highlighting recently reported Phase 2 data. Following this, the company conducted 1x1 meetings with investors on Wednesday, November 12th. The company's financial health is a key topic for these discussions, as evidenced by its reported Current Ratio of 4.91 as of the October 29 announcement, though the company is noted as not yet profitable.

Patient advocacy group outreach for clinical trial enrollment and support

While specific metrics on patient advocacy group engagement are not detailed, the focus on advancing late-stage trials like the Phase 3 REGAL trial for GPS and the Phase 2 study for SLS009 necessitates strong relationships with patient groups to support clinical trial enrollment and patient support infrastructure. The company is targeting difficult-to-treat cancers, which often requires close collaboration with organizations representing those patient populations to ensure trial access and understanding.

Investor relations managing expectations around event-driven trial readouts

Investor relations is heavily event-driven, focusing on managing expectations around critical clinical data readouts. The company provided updates on these events through various channels:

Event/Catalyst	Date/Timing	Relevance to Investor Expectation Management
Phase 3 REGAL Trial Final Analysis	Anticipated by Year-End 2025 (upon 80 events)	Pivotal data readout for lead candidate GPS in AML.
Phase 2 SLS009 Data Presentation	ASH 2025 (Poster session Dec 7, 2025, 6:00-8:00 PM EST)	Update on SLS009 in r/r AML, building on positive Phase 2 data.
Q3 2025 Financial Results & Update	November 12, 2025	Update on cash position, which was $44.3 million as of September 30, 2025, bolstered by $54.6 million in gross warrant proceeds in Sept/Oct 2025.
J.P. Morgan U.S. Opportunities Forum	November 12, 2025	Direct engagement with institutional investors via 1x1 meetings.

Insider activity shows confidence, with insiders buying $100.8K worth of shares in the last 3 months ending November 18, 2025.

Scientific publications and conference presentations (e.g., ASH 2025)

Scientific validation through peer-reviewed presentation is a core relationship driver with the scientific community. SELLAS Life Sciences Group, Inc. had a busy second half of 2025:

• ASH 2025 (December 6 - 9, 2025): Presentation of Phase 2 SLS009 data in r/r AML with MDS-related changes.
• ESMO Congress 2025 (October 17-21, 2025): Presentation of in vivo preclinical data for SLS009 in T-Cell Prolymphocytic Leukemia (T-PLL).
• ASCO 2025 (May 30-June 3, 2025): Poster presentation of preclinical efficacy of SLS009 in ASXL1 mutated colorectal cancer cell lines (Poster Board #: 436).

The preclinical abstract for the ASH presentation was published on the ASH Annual Meeting website and in Blood, providing scientific grounding for the clinical data being presented. Research and development expenses for the first half of 2025 were $7.1 million.

SELLAS Life Sciences Group, Inc. (SLS) - Canvas Business Model: Channels

You're looking at how SELLAS Life Sciences Group, Inc. gets its science and its capital out into the world. For a late-stage biopharma company, the channels are less about retail shelves and more about clinical centers, scientific forums, and the capital markets. Here's the breakdown of the key conduits for SELLAS Life Sciences Group, Inc. as of late 2025.

Global network of clinical trial sites (U.S. and Europe) for drug delivery

The primary channel for delivering the value proposition-novel cancer therapies-is through the execution of its clinical trials. The Phase 3 REGAL trial for galinpepimut-S (GPS) is a global effort. We see direct evidence of this network in the key investigators mentioned. For instance, the University of Alabama (UAB) in the U.S. serves as one of the trial's highest enrolling sites, with Dr. Omer Jamy as the principal investigator. On the European side, Dr. Panagiotis Tsirigotis at the National and Kapodistrian University of Athens, Greece, is noted for enrolling the highest number of patients, confirming active European site engagement. The company is also preparing an 80-patient trial for newly diagnosed AML patients, expected to begin enrollment in the first quarter of 2026, which will require activating additional sites across its network.

Scientific and medical conferences (ASH, ESMO) for data dissemination

Disseminating clinical and preclinical data is crucial for validation and future partnership or commercialization. SELLAS Life Sciences Group, Inc. actively uses major medical congresses as a primary channel for this. The positive Phase 2 data for SLS009 in relapsed/refractory (r/r) AML were accepted for presentation at the American Society of Hematology (ASH) Annual Meeting in December 2025. Furthermore, preclinical data on SLS009 in T-cell prolymphocytic leukemia (T-PLL) were presented at the European Society for Medical Oncology (ESMO) Congress in October 2025 in Berlin, Germany. Internally, the company used a Virtual R&D Day on October 29, 2025, to review these programs with key opinion leaders.

Regulatory submission pathways (e.g., BLA/NDA) to FDA and EMA

The regulatory bodies-the FDA and EMA-are the ultimate gatekeepers, making the submission pathway a critical channel. The final analysis for the Phase 3 REGAL trial is event-driven, anticipated by year-end 2025 once 80 deaths are reached. Based on projections, the BLA submission to the FDA was targeted for October-November 2025, following the final analysis and data lock. For SLS009, the company has already secured significant designations, including FDA Rare Pediatric Disease Designation for pediatric AML and pediatric ALL, and EMA orphan drug designation for AML and peripheral T-cell lymphoma. The FDA also provided feedback in Q2 2025, recommending the next SLS009 trial be an 80-patient study in first-line AML patients.

Direct investor relations and corporate communications for capital raising

Keeping the capital flowing is a constant channel activity. SELLAS Life Sciences Group, Inc. successfully executed significant financing events in 2025. They announced a $25 million registered direct offering in January 2025. More recently, the company received approximately $54.6 million in gross proceeds from warrant exercises in September and October 2025. As of September 30, 2025, the cash and cash equivalents position stood at $44.3 million, bolstered by an additional $29.1 million in net proceeds received in October 2025 from those warrant exercises. The CEO was scheduled for direct investor meetings on November 12, 2025, showing active engagement with the financial community.

Here's a quick look at the recent capital activity as of late 2025:

Financial Event/Metric	Amount/Date
Gross Proceeds from Warrant Exercises (Sept/Oct 2025 Total)	$54.6 million
Net Proceeds Received in October 2025	$29.1 million
Cash & Cash Equivalents (as of September 30, 2025)	$44.3 million
Gross Proceeds from Jan 2025 Offering Warrants Exercised	$23.6 million
Projected Final Analysis Events for GPS Trial	80 deaths

Academic collaborations for preclinical and translational research

The foundation of the pipeline relies on strong academic ties, which act as a channel for early-stage discovery and validation. The lead product candidate, GPS, is explicitly licensed from Memorial Sloan Kettering Cancer Center. This licensing agreement is a key channel for bringing foundational science into the company's development pipeline. The company also noted that preclinical data for SLS009 were presented at ESMO 2025, which stems from translational research efforts. Furthermore, the company is developing pediatric programs for hematological malignancies, which often involves collaboration with specialized academic pediatric centers.

• GPS licensed from Memorial Sloan Kettering Cancer Center.
• Preclinical data for SLS009 presented at ESMO 2025.
• FDA recommended a new trial for SLS009 in first-line AML, with enrollment planned for Q1 2026.
• SLS009 received FDA Rare Pediatric Disease Designation.

SELLAS Life Sciences Group, Inc. (SLS) - Canvas Business Model: Customer Segments

You're looking at the core patient populations SELLAS Life Sciences Group, Inc. is targeting with its late-stage assets, GPS and SLS009, as of late $\text{2025}$. This is where the clinical data translates directly into market opportunity.

The primary focus is on Acute Myeloid Leukemia ($\text{AML}$), a disease with an estimated $\text{22,010}$ new diagnoses in the $\text{US}$ for $\text{2025}$. $\text{AML}$ represents about $\text{1}$ out of $\text{3}$ leukemias in adults.

Acute Myeloid Leukemia (AML) patients in complete remission (CR2)

This segment is the target for the Galinpepimut-S ($\text{GPS}$) Phase 3 $\text{REGAL}$ trial, which is event-driven with a final analysis anticipated by year-end $\text{2025}$ once $\text{80}$ deaths are reached.

• The $\text{REGAL}$ trial involves $\text{126}$ patients achieving $\text{CR2}$ (second complete remission).
• Phase 2 data for $\text{GPS}$ in $\text{CR2}$ patients showed a median survival of $\text{21}$ months versus $\text{5.4}$ months for the comparator, with a $\text{p-value}$ of $\text{0.02}$.

Relapsed/refractory (r/r) AML patients, especially venetoclax-resistant

This segment is the focus for the $\text{SLS009}$ program, which has shown efficacy in patients who have failed prior standard-of-care regimens, including those resistant to venetoclax-based therapy.

Patient Subgroup	SLS009 Median Overall Survival (mOS)	Historical Benchmark mOS
All $\text{r/r}$ to Venetoclax-Based Regimens	$\text{8.8}$ months	Not explicitly stated for this group
$\text{AML}$ Myelodysplasia-Related Changes ($\text{AML-MR}$)	$\text{8.9}$ months	$\sim\text{2.4}$ months

The Overall Response Rate ($\text{ORR}$) for $\text{SLS009}$ in this population was also encouraging:

• $\text{ORR}$ of $\text{33}\%$ in all patients ($\text{n=54}$).
• $\text{ORR}$ of $\text{44}\%$ in $\text{AML-MR}$ patients.
• $\text{ORR}$ of $\text{50}\%$ in $\text{AML-MR}$ with Myelomonocytic/Myelomonoblastic ($\text{M4/M5}$) subtype.

Oncologists and hematologists specializing in blood cancers

These are the treating physicians who prescribe $\text{GPS}$ and $\text{SLS009}$. Their segment is defined by the patient populations they serve, which include the $\text{22,010}$ estimated new $\text{AML}$ cases in $\text{2025}$, with the average patient age being about $\text{69}$ years.

Potential large pharmaceutical/biotech companies for commercial licensing

These entities represent potential strategic partners or acquirers, incentivized by regulatory advantages tied to $\text{SLS}$'s pipeline assets.

• $\text{FDA}$ Rare Pediatric Disease Designation ($\text{RPDD}$) for $\text{GPS}$ in pediatric $\text{AML}$ makes $\text{SLS}$ eligible for a Priority Review Voucher ($\text{PRV}$) upon approval.
• Recent sales valuations for $\text{PRV}$s have been around $\text{\$100}$ million.
• $\text{SLS}$ reported $\text{\$44.3}$ million in cash and cash equivalents as of September $\text{30, 2025}$, supplemented by $\text{\$29.1}$ million in net proceeds from warrant exercises in October $\text{2025}$.

Pediatric AML and ALL patient populations (via RPDD designations)

Both $\text{GPS}$ and $\text{SLS009}$ have secured $\text{RPDD}$ from the $\text{FDA}$ for pediatric $\text{AML}$. $\text{SLS009}$ also holds $\text{RPDD}$ for pediatric $\text{ALL}$.

• The $\text{RPDD}$ for $\text{SLS009}$ in pediatric $\text{AML}$ supports an $\text{80}$-patient trial planned to begin in $\text{Q1 2026}$.
• The designation is for serious or life-threatening diseases affecting fewer than $\text{200,000}$ people in the $\text{US}$, primarily individuals under $\text{18}$.

SELLAS Life Sciences Group, Inc. (SLS) - Canvas Business Model: Cost Structure

You're looking at the core expenditures for SELLAS Life Sciences Group, Inc. as of late 2025. For a late-stage clinical company, the cost structure is heavily weighted toward research and development, which is where the bulk of your capital goes before a product is commercialized.

Here's a quick look at the primary operating expenses reported for the third quarter ending September 30, 2025:

Cost Category	Q3 2025 Amount (USD Millions)	Nine Months Ended Sept 30, 2025 Amount (USD Millions)
Research and Development (R&D) Expense	$4.22 million	$11.3 million
General and Administrative (G&A) Expense	$2.87 million	$8.7 million
Total Operating Expenses (Approximate Sum)	$7.09 million	$20.0 million

The R&D spend is definitely the dominant cost driver, as you'd expect. It's important to note that the R&D expense for the nine months ending September 30, 2025, at $11.3 million, was down from $14.7 million for the same period in 2024. That reduction points directly to specific activities winding down.

The decrease in R&D spend year-over-year was primarily driven by lower costs associated with the clinical programs. Here are the key components that make up that R&D expenditure:

• Clinical trial execution and monitoring costs for the REGAL Phase 3 trial.
• Decreased clinical trial expenses for the SLS009 program.
• Lower manufacturing costs and clinical drug supply purchases.
• Reduced clinical and regulatory consulting costs.

For G&A, the Q3 2025 figure of $2.87 million compared to $3.0 million in Q3 2024. That slight dip was mainly due to lower professional fees, though it was partially offset by higher personnel-related expenses, including non-cash stock-based compensation.

Finally, you have the costs tied to your core assets. The lead product candidate, GPS, is licensed from Memorial Sloan Kettering Cancer Center (MSKCC). While specific ongoing licensing fees aren't broken out in the main expense lines, the initial licensing agreement is a fixed part of the cost structure that supports the development of GPS.

SELLAS Life Sciences Group, Inc. (SLS) - Canvas Business Model: Revenue Streams

You're looking at the financial engine of SELLAS Life Sciences Group, Inc. as of late 2025. For a late-stage clinical biotech like SELLAS Life Sciences Group, Inc., the revenue stream isn't about selling pills yet; it's about funding the journey to get there. Right now, the books reflect this reality.

Currently no product revenue; typical for a late-stage clinical biotech. As of the second quarter of 2025, SELLAS Life Sciences Group, Inc. reported $0.0 in revenue, which is exactly what you'd expect when the focus is entirely on advancing clinical trials for novel cancer therapies like GPS and SLS009, not commercial sales. This lack of sales revenue is the cost of doing late-stage development.

The immediate, tangible revenue stream comes from financing the pipeline. SELLAS Life Sciences Group, Inc. successfully tapped investor commitment through warrant exercises in the recent past. This is crucial cash flow to keep the lights on and the trials running.

Here's a breakdown of the capital infusion from warrant exercises in late 2025:

Financing Event Period	Gross Proceeds Amount	Source Warrants Issued
September and October 2025 Total	$54.6 million	Various (Including Jan 2025, Mar/Aug 2024)
October 2025 Exercise (Specific)	$31.0 million	March and August 2024
September 2025 Exercise (Specific)	$23.6 million	January 2025

This total of $54.6 million in gross proceeds from warrant exercises in September and October 2025 provided significant liquidity. For context, the company reported $44.3 million in cash and cash equivalents as of September 30, 2025, with an additional $29.1 million in net proceeds received in October 2025 from these exercises.

Beyond the current financing activities, the future revenue potential is tied directly to clinical success and strategic deal-making. These are the expected, but not yet realized, revenue sources:

• Potential future milestone payments from commercialization partnerships.
• Potential future product sales or licensing royalties post-regulatory approval.

The company is actively working to secure non-dilutive funding, which is essentially grant money that doesn't require giving up equity or future royalties. This is a key strategic move to offset cash burn.

• Non-dilutive grant funding for specific development programs (applied for). SELLAS Life Sciences Group, Inc. applied for such funding to expand SLS009 development into the frontline setting in Acute Myeloid Leukemia (AML).

Finance: draft 13-week cash view by Friday.