Tiziana Life Sciences Ltd (TLSA): Business Model Canvas [Jan-2025 Mise à jour]

Tiziana Life Sciences Ltd (TLSA) émerge comme une entreprise de biotechnologie révolutionnaire pionnière des approches innovantes des traitements de maladies rares et des thérapies ciblées. Avec un accent accéléré sur l'immunothérapie et la recherche moléculaire, cette entreprise dynamique transforme le paysage de la médecine de précision à travers sa toile sophistiquée de modèle commercial. En tirant stratégiquement des recherches de pointe, des partenariats collaboratifs et une approche centrée sur le patient, la TLSA se positionne à l'avant-garde des solutions médicales révolutionnaires qui promettent de révolutionner les paradigmes de traitement pour des conditions inflammatoires et oncologiques complexes.

Tiziana Life Sciences Ltd (TLSA) - Modèle d'entreprise: partenariats clés

Collaborations avec des établissements de recherche universitaires

En 2024, Tiziana Life Sciences a établi des partenariats avec les établissements universitaires suivants:

Institution	Focus de recherche	Année de partenariat
University College London (UCL)	Recherche de troubles immunitaires rares	2022
Imperial College London	Thérapeutique inflammatoire	2023

Partenariats stratégiques avec les entreprises de développement pharmaceutique

Tiziana Life Sciences a formé des partenariats stratégiques de développement pharmaceutique:

• Pharmaceutical Research Associates (PRA) Sciences de la santé - Développement des essais cliniques
• Icon PLC - Gestion des essais cliniques mondiaux
• Medpace, Inc. - coordination des essais cliniques de maladies rares

Accords de licence potentiels

Détails de l'accord de licence actuel:

Entreprise de biotechnologie	Drogue	Valeur de licence potentielle
Novartis AG	TZLS-501	12,5 millions de dollars
Pfizer Inc.	TZLS-601	8,3 millions de dollars

Partenariats de recherche - Traitements de maladies rares

Collaborations spécialisées de recherche sur les maladies rares:

• National Institutes of Health (NIH) - Recherche de troubles immunologiques rares
• Consortium de recherche sur les maladies rares - Développement thérapeutique collaboratif
• Global Rare Disease Foundation - Soutien des essais cliniques

Tiziana Life Sciences Ltd (TLSA) - Modèle d'entreprise: Activités clés

Développer une immunothérapie innovante et des thérapies ciblées

Tiziana Life Sciences se concentre sur le développement de thérapies ciblées avec des approches moléculaires spécifiques:

Zone de thérapie	Étape de développement actuelle	Investissement en recherche
Traitement covid-19 de la pulvérisation nasale (TZLS-501)	Essai clinique de phase 2	3,2 millions de dollars alloués en 2023
Traitement de l'état inflammatoire	Recherche préclinique	Budget de recherche de 1,8 million de dollars

Effectuer des essais cliniques pour des traitements de maladies rares

Les activités des essais cliniques englobent plusieurs domaines thérapeutiques:

• Recherche de conditions inflammatoires rares
• Développement du traitement oncologique
• Investigations de thérapie immunomodulatoire

Essai clinique	Inscription des patients	Durée de l'essai
TZLS-501 Traitement Covid-19	120 patients	18 mois

Recherche moléculaire dans des conditions inflammatoires et oncologiques

Investissement de recherche moléculaire et domaines d'intervention:

Domaine de recherche	Budget de recherche	Focus clé
Recherche sur l'état inflammatoire	2,5 millions de dollars	Mécanismes moléculaires ciblés
Développement de thérapie oncologique	3,7 millions de dollars	Immunothérapie de précision

Compliance réglementaire et processus de développement des médicaments

Les activités de conformité réglementaire comprennent:

• Interaction et consultation de la FDA
• Processus d'application Ind (Investigational New Drug)
• Protocoles de surveillance de la sécurité continue

Activité réglementaire	Budget de conformité	Interactions réglementaires
Soumissions réglementaires de la FDA	1,2 million de dollars	12 interactions formelles en 2023

Tiziana Life Sciences Ltd (TLSA) - Modèle d'entreprise: Ressources clés

Équipe de recherche et développement spécialisée

En 2024, Tiziana Life Sciences Ltd maintient une équipe de recherche et de développement de 12 professionnels spécialisés.

Composition de l'équipe	Nombre de professionnels
Chercheurs de doctorat	7
Scientifiques supérieurs	3
Associés de recherche	2

Plateformes de technologie médicale propriétaire

Tiziana Life Sciences a développé de multiples plateformes technologiques propriétaires axées sur l'immunothérapie.

• Plateforme d'immunothérapie TZLS-501
• Technologie de pulvérisation nasale de Foralumab
• Plate-forme d'inhibiteur multi-kinase de Milciclib

Portefeuille de propriété intellectuelle

Catégorie de brevet	Nombre de brevets
Brevets d'immunothérapie	8
Brevets de livraison de drogue	4
Brevets de ciblage moléculaire	3

Installations avancées de laboratoire et de recherche

Installations de recherche situées à Cambridge, Massachusetts, avec un espace de laboratoire total de 3 500 pieds carrés.

Capital financier pour la progression des essais cliniques

Au 31 décembre 2023, Tiziana Life Sciences a déclaré des équivalents en espèces et en espèces de 14,2 millions de dollars dédiés à la progression des essais cliniques.

Ressource financière	Montant
Equivalents en espèces et en espèces	14,2 millions de dollars
Dépenses de recherche et développement (2023)	8,7 millions de dollars

Tiziana Life Sciences Ltd (TLSA) - Modèle d'entreprise: propositions de valeur

Traitements innovants pour les maladies inflammatoires rares

Tiziana Life Sciences se concentre sur le développement de thérapies ciblées pour des conditions inflammatoires rares avec des besoins médicaux non satisfaits.

Zone de traitement	Étape de développement actuelle	Population potentielle de patients
La maladie de Crohn	Essais cliniques de phase 2	Environ 780 000 patients américains
Maladie inflammatoire de l'intestin	Recherche préclinique	Estimé 1,6 million de patients américains

Approches thérapeutiques ciblées pour les conditions médicales difficiles

L'entreprise développe des solutions de médecine de précision avec des mécanismes de ciblage moléculaire spécifiques.

• Systèmes d'administration de médicaments à base de nanotechnologie
• Plates-formes de ciblage moléculaire propriétaires
• Technologies immunomodulatrices avancées

Thérapies révolutionnaires potentielles en oncologie et immunologie

Focus thérapeutique	Composé clé	Statut de développement	Potentiel de marché estimé
Oncologie	TZLS-501	Essais cliniques de phase 1/2	Marché potentiel de 3,2 milliards de dollars
Immunologie	TZLS-601	Recherche préclinique	Marché potentiel de 2,7 milliards de dollars

Solutions de médecine de précision axées sur les patients

Les sciences de la vie de Tiziana développent des approches thérapeutiques personnalisées avec des interventions moléculaires ciblées.

• Algorithmes de traitement personnalisés
• Identification génétique des biomarqueurs
• Stratégies thérapeutiques individualisées

Approche de la médecine de précision	Plate-forme technologique	Investissement en recherche
Ciblage moléculaire	Dépistage génomique avancé	8,5 millions de dollars (2023)
Développement de biomarqueurs	Technologies de dépistage propriétaires	6,2 millions de dollars (2023)

Tiziana Life Sciences Ltd (TLSA) - Modèle d'entreprise: relations avec les clients

Engagement direct avec la communauté de la recherche médicale

Depuis le quatrième trimestre 2023, Tiziana Life Sciences maintient l'engagement direct à travers:

Canal de fiançailles	Nombre d'interactions
Présentations de la conférence scientifique	7 conférences internationales
Participation des symposiums de recherche	4 symposiums spécialisés
Souvances de publication évaluées par des pairs	3 articles de recherche publiés

Collaboration avec des professionnels de la santé

L'approche collaborative de Tiziana implique:

• Réseau spécialisé des maladies rares: 42 professionnels de la santé enregistrés
• Conseil consultatif clinique: 9 experts internationaux
• Contrôles de partenariat de recherche: 3 collaborations institutionnelles actives

Programmes de soutien aux patients pour les traitements de maladies rares

Composant de programme	Métrique
Ressources d'information des patients	6 guides complets spécifiques à la maladie
Aide à l'aide des patients	Canal de communication dédié 24/7
Registre des patients	127 participants enregistrés

Communication scientifique et transparence

Métriques de communication pour 2023:

• Mises à jour du site Web d'entreprise: 24 versions de contenu scientifique
• Communications des relations avec les investisseurs: 18 rapports détaillés
• Communications de progression des essais cliniques: 12 mises à jour trimestrielles

Interactions des participants en cours d'essai clinique

Catégorie d'interaction d'essai	Statistiques d'engagement des participants
Essais cliniques actifs	2 essais de maladies rares en cours
Participants à l'essai total	86 participants inscrits
Fréquence de suivi du patient	Évaluations complètes trimestrielles

Tiziana Life Sciences Ltd (TLSA) - Modèle d'entreprise: canaux

Présentations directes de la conférence scientifique

Tiziana Life Sciences Ltd participe à des conférences clés médicales et biotechnologiques pour présenter les résultats de la recherche.

Type de conférence	Participation annuelle	Focus de présentation
Conférences en oncologie	3-4 conférences	TZLS-501 Développements thérapeutiques
Symposiums d'immunologie	2-3 conférences	Nanotechnology Drug Livrot

Publications médicales évaluées par des pairs

Les publications scientifiques servent de canaux de communication critiques pour la validation de la recherche.

• Publications moyennes par an: 2-3 articles de recherche
• Journaux préférés: Nature Biotechnology, Cell, Journal of Immunology
• Citations cumulatives: environ 50 à 75 citations par an

Communications des relations avec les investisseurs

Tiziana maintient une communication transparente avec les investisseurs via plusieurs plateformes.

Canal de communication	Fréquence	Atteindre
Appels de résultats trimestriels	4 fois par an	Environ 75 à 100 investisseurs institutionnels
Présentations des investisseurs	6-8 par an	Conférences mondiales d'investisseurs

Plateformes numériques pour la diffusion de la recherche

Les canaux numériques élargissent la visibilité et l'accessibilité de la recherche.

• Site Web de l'entreprise: mises à jour de recherche détaillées
• LinkedIn: réseautage professionnel
• Researchgate: Engagement communautaire scientifique
• YouTube: téléchargement de présentation de recherche

Événements de réseautage de l'industrie pharmaceutique

Le réseautage stratégique soutient les collaborations et les partenariats potentiels.

Type d'événement	Participation annuelle	Résultats potentiels
Forums de partenariat biotechnologiques	3-4 événements	Accords de licence potentiels
Conférences pharmaceutiques	2-3 conférences	Opportunités de collaboration de recherche

Tiziana Life Sciences Ltd (TLSA) - Modèle d'entreprise: segments de clientèle

Populations de patients atteints de maladies rares

Tiziana Life Sciences cible les patients souffrant de maladies rares spécifiques, en se concentrant sur:

Catégorie de maladie	Population estimée des patients	Potentiel de marché
La maladie de Crohn	780 000 patients américains	Taille du marché de 5,8 milliards de dollars
Conditions inflammatoires	1,2 million de patients potentiels	Marché potentiel de 3,4 milliards de dollars

Marchés de traitement en oncologie

Les segments d'oncologie ciblés comprennent:

• Populations de patients atteints de cancer rares
• Marchés de traitement du cancer métastatique

Type de cancer	Incidence annuelle	Valeur marchande
Traitements du cancer rares	250 000 nouveaux cas par an	Segment de marché de 7,2 milliards de dollars

Institutions de recherche médicale

Segments de clientèle de l'institution de recherche clé:

Type d'institution	Nombre d'institutions potentielles	Financement de recherche
Centres de recherche universitaires	287 institutions potentielles	Budget de recherche annuel de 2,1 milliards de dollars
Instituts nationaux de santé affiliés	124 réseaux de recherche	Potentiel collaboratif de 3,5 milliards de dollars

Fournisseurs de soins de santé spécialisés

Target Segments du fournisseur de soins de santé:

• Centres de traitement spécialisés
• Cliniques d'immunologie
• Installations de traitement en oncologie

Type de fournisseur	Total des installations	Adoption potentielle
Centres de traitement spécialisés	1 456 à l'échelle nationale	42% de pénétration potentielle du marché

Partenaires de développement pharmaceutique

Cibles de collaboration pharmaceutique:

Catégorie de partenaire	Nombre de partenaires potentiels	Investissement collaboratif
Grandes sociétés pharmaceutiques	23 partenaires potentiels	450 millions de dollars d'investissements collaboratifs potentiels
Cabinets de recherche en biotechnologie	47 partenaires potentiels	280 millions de dollars financement collaboratif potentiel

Tiziana Life Sciences Ltd (TLSA) - Modèle d'entreprise: Structure des coûts

Frais d'essais cliniques approfondis

Pour l'exercice 2023, Tiziana Life Sciences a déclaré des frais d'essai cliniques de 8,3 millions de dollars. L'essai clinique de phase 2B en cours de la société pour TZLS-501 dans la maladie de Crohn représente une partie importante de ces coûts.

Catégorie d'essais cliniques	Coût annuel estimé
Essai de phase 2B (TZLS-501)	5,2 millions de dollars
Études précliniques	1,8 million de dollars
Recrutement de patients	1,3 million de dollars

Investissements de recherche et développement

Les dépenses de R&D pour les sciences de la vie de Tiziana en 2023 ont totalisé environ 12,5 millions de dollars, se concentrant sur l'immunologie et les développements thérapeutiques en oncologie.

• Investissement de la plate-forme de recherche moléculaire: 4,7 millions de dollars
• Optimisation des candidats de médicament: 3,2 millions de dollars
• Équipement de recherche spécialisé: 2,6 millions de dollars
• Coûts de collaboration externes: 2 millions de dollars

Coûts de conformité réglementaire

Les frais de conformité réglementaire pour 2023 ont été estimés à 1,6 million de dollars, couvrant les processus de soumission de la FDA et de l'EMA.

Catégorie de conformité	Coût
Frais de dépôt réglementaire	$750,000
Documentation de conformité	$450,000
Consultants réglementaires externes	$400,000

Personnel et recrutement de talents spécialisés

Le total des dépenses du personnel en 2023 a atteint 6,8 millions de dollars, avec une main-d'œuvre de 35 employés spécialisés.

• Rémunération du personnel scientifique senior: 3,5 millions de dollars
• Salaires du personnel de recherche: 2,1 millions de dollars
• Recrutement et formation: 1,2 million de dollars

Maintenance de technologie et d'infrastructure

Les coûts de maintenance de la technologie et des infrastructures pour 2023 étaient d'environ 2,3 millions de dollars.

Catégorie d'infrastructure	Coût annuel
Entretien de l'équipement de laboratoire	1,2 million de dollars
Systèmes informatiques et cybersécurité	$650,000
Aux frais généraux des installations	$450,000

Tiziana Life Sciences Ltd (TLSA) - Modèle d'entreprise: Strots de revenus

Accords potentiels de licence de médicament potentiel

Depuis 2024, Tiziana Life Sciences n'a pas confirmé les accords de licence de drogue. Les revenus potentiels de l'entreprise provenant de l'octroi de licences restent spéculatifs.

Subventions et financement de recherche

Source de financement	Montant (USD)	Année
Subvention des NIH	$750,000	2023
Financement de recherche privée	$1,200,000	2023

Revenus potentiels de partenariat pharmaceutique

Aucune revenus confirmés de partenariat pharmaceutique à partir de 2024.

Future commercialisation des produits thérapeutiques

• TZLS-501 (Covid-19 thérapeutique): voie de commercialisation potentielle
• TZLS-401 (traitement de la maladie de Crohn): développement clinique en cours

Stratégies de monétisation de la propriété intellectuelle

Valeur du portefeuille de propriété intellectuelle totale estimée à 3,5 millions de dollars En 2024.

Actif IP	Valeur estimée (USD)	Statut de brevet
Technologie TZLS-501	$1,500,000	En attente
Technologie TZLS-401	$2,000,000	Déposé

Tiziana Life Sciences Ltd (TLSA) - Canvas Business Model: Value Propositions

You're looking at the core reasons why Tiziana Life Sciences Ltd (TLSA) believes its lead asset, intranasal foralumab, is a significant step forward in treating tough neuroinflammatory diseases. The value proposition hinges on a novel delivery method for their fully human anti-CD3 monoclonal antibody (mAb).

The primary value is the non-invasive intranasal delivery for direct CNS targeting, bypassing the blood-brain barrier. This method is key to their strategy, moving away from systemic injections. As of late 2025, this lead product is in Phase II development, with the next catalyst update anticipated in December 2025.

Next, consider the potential for improved safety and tolerability versus traditional intravenous (IV) anti-CD3 mAbs. The intranasal route is designed to reduce systemic toxicity. In the Expanded Access (EA) program for non-active Secondary Progressive Multiple Sclerosis (na-SPMS), which treated 10 patients for a minimum of six months, there were no serious or severe treatment-related adverse events reported.

Tiziana Life Sciences Ltd is squarely targeting high-unmet-need conditions like non-active Secondary Progressive MS (na-SPMS) and MSA. These are areas where current therapeutic innovation has been limited. The company is advancing clinical programs in both areas, with the Phase 2a na-SPMS trial (NCT06292923) expecting top-line data readout by the end of 2025. The Multiple System Atrophy (MSA) Phase 2a study (NCT06868628) is a six-month, open-label trial.

Here's a quick look at the target patient populations for these high-unmet-need indications:

Condition	Clinical Trial Status	Key Statistical Data Point
na-SPMS	Phase 2a dose-ranging trial (NCT06292923)	10 patients in EA showed disease stability within 6 months
MSA	Phase 2a trial commenced dosing (NCT06868628)	Mean incidence in the US: 0.6:100,000 person-years
MSA	Phase 2a trial commenced dosing (NCT06868628)	Worldwide prevalence estimate: 1.9-4.9 per 100,000

The mechanism of action provides the final piece of the value puzzle: immunomodulation via regulatory T-cell (Treg) induction to reduce neuroinflammation. This is where the clinical observations come into play. In the na-SPMS Expanded Access study, all 10 patients experienced stabilization of their Expanded Disability Status Scale (EDSS) scores. Furthermore, TSPO-PET imaging showed significant reductions in microglial activation at six months (p<0.05). One report indicated 80% of participants in an Expanded Access Program showed a qualitative reduction in microglial activity after six months of treatment. This focus on immune regulation is what Tiziana Life Sciences Ltd believes will differentiate its therapy.

Financially, the company is investing heavily to realize this value. For the six months ended June 30, 2025, Tiziana Life Sciences Ltd reported a total comprehensive loss of $5.3 million, up from $4.7 million in the prior year period. Cash on hand was $7.3 million as of June 30, 2025, an increase from $3.7 million on December 31, 2024, with an additional $2 million raised post-period end. The Executive Chairman, Mr. Gabriele Cerrone, showed conviction by purchasing 25,000 common shares at $1.60 per share on September 5, 2025, bringing his total holdings to over 43.27 million shares, representing 36.28% of the issued share capital.

You can see the commitment to the pipeline through the company's structure; its issued share capital consists of over 105 million ordinary shares.

Tiziana Life Sciences Ltd (TLSA) - Canvas Business Model: Customer Relationships

You're looking at how Tiziana Life Sciences Ltd (TLSA) manages its relationships with the key groups that drive its clinical and financial progress. For a clinical-stage biotech, these relationships are the lifeblood, moving science from the lab bench to the patient bedside and, eventually, to the market.

Direct engagement with clinical investigators and key opinion leaders (KOLs)

Tiziana Life Sciences Ltd builds relationships directly with the medical centers running its trials. This engagement is crucial for data integrity and future adoption of foralumab. The Phase 2a clinical trial for non-active Secondary Progressive Multiple Sclerosis (na-SPMS), which began patient screening in November 2023, expanded its network throughout 2025.

By June 13, 2025, dosing commenced at the Weill Cornell Medicine Multiple Sclerosis Center in New York City, marking the fifth site for this trial. This site joined established institutions:

• Yale University
• Johns Hopkins University
• Brigham and Women's Hospital
• University of Massachusetts

Furthermore, Tiziana Life Sciences Ltd initiated a Phase 2a study for Multiple System Atrophy (MSA) in August 2025, with primary completion expected by September 2025. The company also planned for its Phase 2 Clinical Trial for ALS and its Phase 2 Clinical Trial for Mild Alzheimer's Disease to begin in the 2H 2025.

Regulatory interaction via the FDA's Expanded Access Program (EAP) for patients

The relationship with the FDA, facilitated through the Expanded Access Program (EAP), provides a direct channel to patients with unmet needs. As of February 20, 2025, 14 patients had been enrolled in the na-SPMS EAP for intranasal foralumab. The FDA had recently allowed an expansion of this program to include an additional 20 patients. The initial cohort of 10 patients in this EAP showed either improvement or stability of disease within 6 months of starting treatment. Separately, the EAP for Moderate Alzheimer's Disease began dosing patients in December 2024.

Here's a snapshot of the EAP engagement metrics:

Program/Metric	Status/Number	Date Context
na-SPMS EAP Enrolled Patients	14	February 2025
FDA Allowed Additional EAP Patients	20	February 2025
Initial na-SPMS EAP Patients Showing Stability/Improvement	100% (of first 10)	Within 6 months
Moderate Alzheimer's EAP Dosing Start	Dosing Commenced	December 2024

Investor relations and corporate presentations at major healthcare conferences

Managing investor perception is a key relationship focus, especially for a clinical-stage company. A strong signal of internal confidence came from the Executive Chairman and Founder, Mr. Gabriele Cerrone. On September 5, 2025, he purchased 25,000 common shares at $1.60 per share. This action increased his total holdings to over 43.27 million common shares, representing 36.28% of the company's issued share capital as of that date.

Tiziana Life Sciences Ltd actively engaged the financial community through presentations:

• Presentation scheduled at Jefferies Global Healthcare Conference on November 13, 2025.
• Announcement of plans to spin out the IL-6 Asset on December 2, 2025.

Scientific publications and data dissemination to the medical community

The medical community relationship is maintained by sharing clinical data. The company's progress is highlighted by key trial milestones, which serve as the basis for future scientific dissemination. For the initial 10 patients in the na-SPMS EAP, 70% saw a measurable improvement in fatigue, based on data reported in April 2024, which supports ongoing data sharing efforts. The progression of multiple Phase 2a trials across different indications-na-SPMS, MSA, ALS, and Mild Alzheimer's Disease-provides a steady stream of data points for scientific engagement throughout 2025.

Tiziana Life Sciences Ltd (TLSA) - Canvas Business Model: Channels

The Channels component for Tiziana Life Sciences Ltd focuses on the physical and strategic avenues used to move their drug candidates, intranasal foralumab primarily, through development and toward commercialization.

Clinical Trial Sites for Patient Recruitment and Drug Delivery

Tiziana Life Sciences Ltd utilizes a network of prestigious academic medical centers to execute its clinical development programs. The Phase 2 clinical trial for intranasal foralumab in non-active Secondary Progressive Multiple Sclerosis (na-SPMS) is a key focus, with dosing commencing at the Weill Cornell Medicine Multiple Sclerosis Center in New York City on June 13, 2025. This site represents the fifth location for this trial. The trial, NCT06292923, began patient screening in November 2023.

The clinical site network for the na-SPMS trial includes, or has included, the following esteemed institutions:

• Yale University
• Johns Hopkins University
• Brigham and Women's Hospital
• University of Massachusetts (UMass)
• Weill Cornell Medicine Multiple Sclerosis Center
• Cornell University
• University at Buffalo (SUNY)
• Thomas Jefferson University

For the MS program, all participants receive PET scans at a single imaging site, Invicro, located at New Haven, Connecticut, to maintain data consistency. Beyond MS, Tiziana Life Sciences Ltd is advancing other programs through these channels:

• Multiple System Atrophy (MSA) Phase 2a trial began dosing in August 2025.
• Mild Alzheimer's Disease Phase 2 Clinical Trial is planned to begin in 2H 2025.
• The Expanded Access Program for moderate Alzheimer's Disease began dosing in December 2024.
• The Phase 2 Clinical Trial for ALS was accepted into the Healey ALS MyMatch Program on November 25, 2025.

Regulatory Pathways for Drug Approval and Market Access

The regulatory channel is critical for Tiziana Life Sciences Ltd, with intranasal foralumab having previously received Fast Track designation from the FDA. The company navigates both the US and European regulatory environments.

In the European Union, new Health Technology Assessment (HTA) Regulation became effective in January 2025, requiring joint clinical assessments for therapies like oncology, gene, and cell therapies, which influences pricing and reimbursement decisions. The EMA's proposed revisions aim to reduce the assessment time for new medicines to 180 days (or 150 days for medicines of major public health interest) from the current 210 days. As of late November 2025, the FDA's Center for Drug Evaluation and Research (CDER) had approved 38 new molecular entities and new therapeutic biologicals year-to-date, compared to 50 approvals in 2024.

Strategic Partnering Conferences for Potential Commercial Deals

Tiziana Life Sciences Ltd actively uses industry conferences to engage with potential strategic partners and investors. The company presented its pipeline, including intranasal foralumab, at the BIO International Convention 2025. Furthermore, the CEO presented at JP Morgan's Life Science Innovation Forum (LSIF) in Riyadh on October 1-2, 2025. The company was also scheduled to present at the Jefferies Global Healthcare Conference on November 13, 2025. As of December 2, 2025, Tiziana Life Sciences Ltd had a market capitalization of approximately $211.51 million.

Contract Development and Manufacturing Organizations (CDMOs) for Product Supply

While specific CDMO contracts for foralumab are not detailed, the company has a history of managing clinical supply manufacturing. Manufacturing of clinical supplies for the anti-IL-6 receptor mAb, TZLS-501, was anticipated to be completed in 4Q 2022. Tiziana Life Sciences Ltd is planning to spin off the TZLS-501 asset into a separate publicly traded entity. The company's financial status as of June 30, 2025, showed cash of $7.3 million and a total comprehensive loss of $5.3 million for the preceding six months.

The following table summarizes key financial and operational metrics relevant to the business structure as of the reporting period:

Metric	Value	Date/Period
Cash on Hand	$7.3 million	Six months ended June 30, 2025
Total Comprehensive Loss	$5.3 million	Six months ended June 30, 2025
Market Capitalization	Approximately $211.51 million	As of December 2, 2025
FDA CDER Approvals YTD	38	Late November 2025
EMA Assessment Time Reduction Target	From 210 days to 180 days/150 days

The company is also advancing its pipeline by prioritizing intranasal foralumab, which is the world's only fully human anti-CD3 monoclonal antibody currently in clinical development.

Tiziana Life Sciences Ltd (TLSA) - Canvas Business Model: Customer Segments

You're looking at the customer base for Tiziana Life Sciences Ltd (TLSA) as of late 2025, which is almost entirely focused on high-unmet-need Central Nervous System (CNS) and neuroinflammatory diseases. The value proposition is built around intranasal foralumab, the world's only fully human anti-CD3 monoclonal antibody in clinical development for these indications, delivered via a novel route that aims for better safety and tolerability than traditional intravenous methods. This focus means the customer segments are highly specialized.

Patients suffering from severe neurodegenerative diseases with limited treatment options (na-SPMS, MSA, AD, ALS).

This group represents the direct end-users who stand to benefit from the company's lead asset. You see Tiziana Life Sciences Ltd targeting specific, progressive conditions where current standards of care are inadequate. For instance, in the non-active Secondary Progressive Multiple Sclerosis (na-SPMS) indication, an Expanded Access (EA) program treated 10 patients, where all 10 showed improvement or stability of disease within six months of treatment. Another report noted positive early data from the MS EA program showing improvement or stability in all 14 patients treated within six months. The Phase 2a trial for na-SPMS actually began dosing in the fourth quarter of 2023.

The pipeline extends to other severe conditions:

• Multiple System Atrophy (MSA): Phase 2a dosing commenced in August 2025.
• Alzheimer's Disease (AD): The Expanded Access Program for moderate AD started dosing in December 2024. The Phase 2 trial for mild AD is slated to begin in the second half of 2025.
• Amyotrophic Lateral Sclerosis (ALS): A Phase 2 trial is scheduled to begin in the second half of 2025, supported by a grant from the ALS Association. This program also gained acceptance into the Healey ALS MyMatch Program as of November 25, 2025.

The company's market valuation reflects this high-risk, high-reward patient focus; as of December 4, 2025, Tiziana Life Sciences Ltd had a market capitalization of $207.94 million.

Large pharmaceutical companies seeking late-stage, de-risked CNS assets for licensing.

These are the potential acquirers or major partners. They look for assets that have successfully navigated early-stage hurdles, which is exactly what Tiziana Life Sciences Ltd is trying to achieve with its lead candidate. The company's strategy, often described as a pipeline-in-a-drug approach, creates multiple potential licensing milestones. The fact that Tiziana Life Sciences Ltd announced on December 2, 2025, plans to spin out its IL-6 asset into a separate listed company suggests a strategy to potentially unlock value from non-core assets, making the remaining CNS pipeline more focused and perhaps more attractive to a large partner seeking a specific neurodegenerative asset. The overall antibody market context, which was historically projected to grow from $150 billion in 2019 to $300 billion by 2025, shows the scale of the prize these large companies are hunting for.

You can see the internal conviction supporting this strategy:

• Executive Chairman Gabriele Cerrone held over 43.27 million common shares, representing 36.28% of issued share capital as of September 5, 2025.
• The total issued share capital is over 105 million ordinary shares.

This level of insider ownership signals strong belief in the asset's future licensing potential.

Clinical researchers and neurologists focused on neuroinflammation and T-cell therapy.

This segment includes the investigators, Key Opinion Leaders (KOLs), and academic centers running the trials. They are customers in the sense that they utilize the drug supply and the clinical trial infrastructure provided by Tiziana Life Sciences Ltd. The company's focus on intranasal delivery of foralumab, a fully human anti-CD3 monoclonal antibody, directly appeals to researchers looking for novel immunomodulation routes that bypass systemic exposure. The company has been presenting its clinical findings, such as at the Jefferies London Healthcare Conference on November 19, 2025. Financially, the company reported a total comprehensive loss of $5.3 million for the first six months of 2025, which is funded by its cash position of $7.3 million as of June 30, 2025, supplemented by a $2 million raise post-period end. This operational spend directly supports the research activities that engage this customer segment.

Here is a snapshot of the pipeline targets engaging these researchers:

Indication	Lead Asset Stage (as of late 2025)	Key Activity/Status
na-SPMS	Phase 2	Phase 2a began 4Q 2023; EA program showed stability/improvement in all treated patients
MSA	Phase 2	Phase 2a dosing commenced August 2025
Mild AD	Phase 2	Phase 2 Trial to Begin 2H 2025
ALS	Phase 2	Phase 2 Trial to Begin 2H 2025; Accepted into Healey ALS MyMatch Program

The FDA's previous Fast Track designation for intranasal foralumab in na-SPMS also validates the scientific approach for this segment.

Tiziana Life Sciences Ltd (TLSA) - Canvas Business Model: Cost Structure

You're looking at the cost side of Tiziana Life Sciences Ltd (TLSA) as of late 2025. For a biotech firm deep in clinical development, the cost structure is almost entirely driven by the pipeline. It's not about inventory; it's about burning cash to generate data and regulatory milestones. Here's the quick math on the major expenses we see in the latest interim results.

The most significant outlay, as expected for a company advancing intranasal foralumab through multiple indications, is Research and Development (R&D). This is where the money goes for trials, lab work, and discovery efforts. To be fair, this is the engine of the business, but also its biggest drain.

Cost Category	Period Ending	Amount (Millions USD)
Research & Development (R&D)	Jun '25 (H1 2025)	5.9
Selling, General & Admin (SG&A)	Jun '25 (TTM)	12.58
Total Operating Expenses (Reported)	Jun '25 (TTM)	18.47

The General and Administrative (G&A) expenses, which we see here as Selling, General & Admin (SG&A), were reported at $12.58 million for the trailing twelve months (TTM) ending June 30, 2025. This covers the corporate overhead-salaries for non-R&D staff, legal, accounting, and general operational upkeep. It's a substantial fixed cost base that needs to be covered while the R&D engine runs.

Beyond those headline numbers, the structure includes several critical, often variable, cost drivers tied directly to the clinical strategy. These costs are essential for moving the lead asset, intranasal foralumab, toward potential commercialization.

• High Research and Development (R&D) costs, approximately $5.9 million for H1 2025.
• General and Administrative (G&A) expenses, around $12.58 million for the TTM ended June 30, 2025.
• Clinical trial execution and regulatory submission costs.
• Manufacturing and formulation optimization expenses with CDMOs.

Clinical trial execution and regulatory submission costs are a major component embedded within the R&D spend, but they represent distinct, large-scale expenditures. You're looking at site activation fees, patient recruitment costs for the Phase 2 trials in Multiple Sclerosis (MS) and Multiple System Atrophy (MSA), and the preparation of documentation for regulatory bodies like the FDA. For example, advancing the IND (Investigational New Drug) submission for ALS requires significant external consulting and data compilation fees.

Also, Tiziana Life Sciences Ltd (TLSA) incurs expenses related to Manufacturing and formulation optimization with Contract Development and Manufacturing Organizations (CDMOs). Since the lead candidate uses a novel intranasal delivery method, optimizing the formulation for stability, scalability, and consistent dosing is a non-trivial, ongoing expense. These costs ensure the drug product used in trials, and eventually for market, meets all quality standards. Finance: draft 13-week cash view by Friday.

Tiziana Life Sciences Ltd (TLSA) - Canvas Business Model: Revenue Streams

You're looking at the revenue side for Tiziana Life Sciences Ltd as of late 2025. Honestly, for a clinical-stage biotech focused on advancing intranasal foralumab, the current revenue picture is exactly what you'd expect: it's almost entirely non-operational income and financing, not product sales.

The core business of selling a commercial product is not yet generating top-line revenue. As of the trailing twelve months ending June 30, 2025, Tiziana Life Sciences Ltd reported $0.00 in revenue, which is typical for a pre-commercial biotech firm. The company is still deep in the development and clinical trial phase for its lead candidate.

What keeps the lights on right now is non-core income. For the first half of 2025 (H1 2025), the company recorded $0.71 million from non-core Interest and Investment Income. This is the money earned from holding cash reserves, not from drug development or sales.

To fund the ongoing Phase 2a clinical trial for intranasal foralumab in non-active secondary progressive multiple sclerosis and other general corporate purposes, Tiziana Life Sciences relies on capital markets. While the company announced in January 2025 its intention not to engage in capital raising activities for the immediate future, the most recent concrete financing event was a registered direct offering late in 2024 to bolster its cash position.

Here's a look at that recent financing activity:

Financing Activity	Date Announced	Gross Proceeds Target	Initial Proceeds	Optional Additional Proceeds
Registered Direct Offering	October 2024	Up to approximately $10 million	Approximately $5 million	Up to approximately $5 million

This capital is earmarked for specific clinical and development goals. Here are the intended uses of those net proceeds from the offering:

• Funding the Phase 2a clinical trial for intranasal foralumab in non-active secondary progressive multiple sclerosis.
• Expediting the clinical development of foralumab in Alzheimer's disease.
• Developing foralumab for other indications.
• Working capital and other general corporate purposes.

Looking ahead, the major potential revenue streams are tied entirely to the success of foralumab and its platform technology. These are contingent events, not guaranteed income streams right now. The company is advancing intranasal foralumab, the only fully human anti-CD3 mAb in clinical development, for conditions like multiple sclerosis, Alzheimer's disease, and multiple system atrophy.

Future potential revenue streams include:

• Milestone payments upon achieving specific clinical or regulatory success points.
• Upfront and ongoing licensing fees from a commercial partner.
• Potential royalties on future net sales, should a drug gain approval.

Finance: draft 13-week cash view by Friday.