Tiziana Life Sciences Ltd (TLSA): Business Model Canvas

Tiziana Life Sciences Ltd (TLSA) entwickelt sich zu einem bahnbrechenden Biotechnologieunternehmen, das innovative Ansätze für die Behandlung seltener Krankheiten und gezielte Therapien vorantreibt. Mit einem messerscharfen Fokus auf Immuntherapie und molekulare Forschung verändert dieses dynamische Unternehmen die Landschaft der Präzisionsmedizin durch sein ausgefeiltes Business Model Canvas. Durch die strategische Nutzung modernster Forschung, Kooperationen und eines patientenzentrierten Ansatzes positioniert sich TLSA an der Spitze bahnbrechender medizinischer Lösungen, die eine Revolution der Behandlungsparadigmen für komplexe entzündliche und onkologische Erkrankungen versprechen.

Tiziana Life Sciences Ltd (TLSA) – Geschäftsmodell: Wichtige Partnerschaften

Kooperationen mit akademischen Forschungseinrichtungen

Seit 2024 hat Tiziana Life Sciences Partnerschaften mit folgenden akademischen Institutionen aufgebaut:

Institution	Forschungsschwerpunkt	Jahr der Partnerschaft
University College London (UCL)	Forschung zu seltenen Immunerkrankungen	2022
Imperial College London	Therapeutika für entzündliche Erkrankungen	2023

Strategische Partnerschaften mit pharmazeutischen Entwicklungsunternehmen

Tiziana Life Sciences hat strategische pharmazeutische Entwicklungspartnerschaften geschlossen:

• Pharmaceutical Research Associates (PRA) Gesundheitswissenschaften – Entwicklung klinischer Studien
• ICON plc – Globales Management klinischer Studien
• Medpace, Inc. – Koordination klinischer Studien zu seltenen Krankheiten

Mögliche Lizenzvereinbarungen

Aktuelle Lizenzvertragsdetails:

Biotechnologieunternehmen	Arzneimittelkandidat	Potenzieller Lizenzwert
Novartis AG	TZLS-501	12,5 Millionen US-Dollar
Pfizer Inc.	TZLS-601	8,3 Millionen US-Dollar

Forschungspartnerschaften – Behandlungen seltener Krankheiten

Spezialisierte Forschungskooperationen für seltene Krankheiten:

• National Institutes of Health (NIH) – Forschung zu seltenen immunologischen Erkrankungen
• Forschungskonsortium für seltene Krankheiten – Gemeinsame therapeutische Entwicklung
• Global Rare Disease Foundation – Unterstützung klinischer Studien

Tiziana Life Sciences Ltd (TLSA) – Geschäftsmodell: Hauptaktivitäten

Entwicklung innovativer Immuntherapien und zielgerichteter Therapien

Tiziana Life Sciences konzentriert sich auf die Entwicklung gezielter Therapien mit spezifischen molekularen Ansätzen:

Therapiebereich	Aktueller Entwicklungsstand	Forschungsinvestitionen
Nasenspray-COVID-19-Behandlung (TZLS-501)	Klinische Phase-2-Studie	Im Jahr 2023 werden 3,2 Millionen US-Dollar bereitgestellt
Behandlung entzündlicher Erkrankungen	Präklinische Forschung	Forschungsbudget von 1,8 Millionen US-Dollar

Durchführung klinischer Studien zur Behandlung seltener Krankheiten

Klinische Studienaktivitäten umfassen mehrere therapeutische Bereiche:

• Forschung zu seltenen entzündlichen Erkrankungen
• Entwicklung onkologischer Behandlungen
• Untersuchungen zur immunmodulatorischen Therapie

Klinische Studie	Patientenregistrierung	Testdauer
TZLS-501 COVID-19-Behandlung	120 Patienten	18 Monate

Molekulare Forschung bei entzündlichen und onkologischen Erkrankungen

Investitionen und Schwerpunkte in der Molekularforschung:

Forschungsbereich	Forschungsbudget	Schwerpunkt
Forschung zu entzündlichen Erkrankungen	2,5 Millionen Dollar	Gezielte molekulare Mechanismen
Onkologische Therapieentwicklung	3,7 Millionen US-Dollar	Präzise Immuntherapie

Einhaltung gesetzlicher Vorschriften und Arzneimittelentwicklungsprozesse

Zu den Aktivitäten zur Einhaltung gesetzlicher Vorschriften gehören:

• Interaktion und Beratung mit der FDA
• IND-Antragsprozesse (Investigational New Drug).
• Kontinuierliche Sicherheitsüberwachungsprotokolle

Regulierungstätigkeit	Compliance-Budget	Regulatorische Interaktionen
Zulassungsanträge der FDA	1,2 Millionen US-Dollar	12 formelle Interaktionen im Jahr 2023

Tiziana Life Sciences Ltd (TLSA) – Geschäftsmodell: Schlüsselressourcen

Spezialisiertes Forschungs- und Entwicklungsteam

Ab 2024 unterhält Tiziana Life Sciences Ltd ein Forschungs- und Entwicklungsteam von 12 spezialisierten Fachleuten.

Teamzusammensetzung	Anzahl der Fachkräfte
Doktoranden	7
Leitende Wissenschaftler	3
Wissenschaftliche Mitarbeiter	2

Proprietäre Plattformen für Medizintechnik

Tiziana Life Sciences hat mehrere proprietäre Technologieplattformen mit Schwerpunkt auf Immuntherapie entwickelt.

• TZLS-501 Immuntherapie-Plattform
• Foralumab-Nasenspray-Technologie
• Milciclib Multi-Kinase-Inhibitor-Plattform

Portfolio für geistiges Eigentum

Patentkategorie	Anzahl der Patente
Patente für Immuntherapie	8
Patente zur Arzneimittelverabreichung	4
Patente für molekulares Targeting	3

Fortschrittliche Labor- und Forschungseinrichtungen

Forschungseinrichtungen in Cambridge, Massachusetts, mit einer Gesamtlaborfläche von 3.500 Quadratmetern.

Finanzielles Kapital für den Fortschritt klinischer Studien

Zum 31. Dezember 2023 meldete Tiziana Life Sciences Bargeld und Zahlungsmitteläquivalente in Höhe von 14,2 Millionen US-Dollar, die für den Fortschritt klinischer Studien bestimmt waren.

Finanzielle Ressource	Betrag
Zahlungsmittel und Zahlungsmitteläquivalente	14,2 Millionen US-Dollar
Forschungs- und Entwicklungsausgaben (2023)	8,7 Millionen US-Dollar

Tiziana Life Sciences Ltd (TLSA) – Geschäftsmodell: Wertversprechen

Innovative Behandlungen für seltene entzündliche Erkrankungen

Tiziana Life Sciences konzentriert sich auf die Entwicklung gezielter Therapien für seltene entzündliche Erkrankungen mit ungedecktem medizinischem Bedarf.

Behandlungsbereich	Aktueller Entwicklungsstand	Potenzielle Patientenpopulation
Morbus Crohn	Klinische Studien der Phase 2	Ungefähr 780.000 US-Patienten
Entzündliche Darmerkrankung	Präklinische Forschung	Schätzungsweise 1,6 Millionen US-Patienten

Gezielte Therapieansätze bei anspruchsvollen Krankheitsbildern

Das Unternehmen entwickelt Präzisionsmedizinlösungen mit spezifischen molekularen Targeting-Mechanismen.

• Nanotechnologiebasierte Arzneimittelverabreichungssysteme
• Proprietäre molekulare Targeting-Plattformen
• Fortschrittliche immunmodulatorische Technologien

Mögliche bahnbrechende Therapien in der Onkologie und Immunologie

Therapeutischer Fokus	Schlüsselverbindung	Entwicklungsstand	Geschätztes Marktpotenzial
Onkologie	TZLS-501	Klinische Studien der Phase 1/2	Potenzieller Markt im Wert von 3,2 Milliarden US-Dollar
Immunologie	TZLS-601	Präklinische Forschung	2,7 Milliarden US-Dollar potenzieller Markt

Patientenorientierte Lösungen für die Präzisionsmedizin

Tiziana Life Sciences entwickelt personalisierte Therapieansätze mit gezielten molekularen Interventionen.

• Personalisierte Behandlungsalgorithmen
• Identifizierung genetischer Biomarker
• Individualisierte Therapiestrategien

Präzisionsmedizinischer Ansatz	Technologische Plattform	Forschungsinvestitionen
Molekulares Targeting	Erweitertes genomisches Screening	8,5 Millionen US-Dollar (2023)
Biomarker-Entwicklung	Proprietäre Screening-Technologien	6,2 Millionen US-Dollar (2023)

Tiziana Life Sciences Ltd (TLSA) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit der medizinischen Forschungsgemeinschaft

Ab dem vierten Quartal 2023 unterhält Tiziana Life Sciences direktes Engagement durch:

Engagement-Kanal	Anzahl der Interaktionen
Wissenschaftliche Konferenzpräsentationen	7 internationale Konferenzen
Teilnahme an Forschungssymposien	4 Fachsymposien
Von Experten begutachtete Veröffentlichungseinreichungen	3 veröffentlichte Forschungsarbeiten

Zusammenarbeit mit medizinischem Fachpersonal

Tizianas kollaborativer Ansatz umfasst:

• Netzwerk von Spezialisten für seltene Krankheiten: 42 registrierte medizinische Fachkräfte
• Klinischer Beirat: 9 internationale Experten
• Forschungspartnerschaftsvereinbarungen: 3 aktive institutionelle Kooperationen

Patientenunterstützungsprogramme für die Behandlung seltener Krankheiten

Programmkomponente	Metriken
Ressourcen für Patienteninformationen	6 umfassende krankheitsspezifische Leitfäden
Hotline zur Patientenunterstützung	Dedizierter Kommunikationskanal rund um die Uhr
Patientenregister	127 angemeldete Teilnehmer

Wissenschaftliche Kommunikation und Transparenz

Kommunikationskennzahlen für 2023:

• Aktualisierungen der Unternehmenswebsite: 24 Veröffentlichungen wissenschaftlicher Inhalte
• Investor-Relations-Kommunikation: 18 ausführliche Berichte
• Mitteilungen zum Fortschritt klinischer Studien: 12 vierteljährliche Aktualisierungen

Laufende Interaktionen zwischen Teilnehmern klinischer Studien

Testinteraktionskategorie	Statistiken zum Teilnehmerengagement
Aktive klinische Studien	2 laufende Studien zu seltenen Krankheiten
Gesamtzahl der Testteilnehmer	86 eingeschriebene Teilnehmer
Häufigkeit der Patientennachsorge	Vierteljährliche umfassende Bewertungen

Tiziana Life Sciences Ltd (TLSA) – Geschäftsmodell: Kanäle

Direkte wissenschaftliche Konferenzpräsentationen

Tiziana Life Sciences Ltd nimmt an wichtigen medizinischen und biotechnologischen Konferenzen teil, um Forschungsergebnisse vorzustellen.

Konferenztyp	Jährliche Teilnahme	Präsentationsschwerpunkt
Onkologische Konferenzen	3-4 Konferenzen	TZLS-501 therapeutische Entwicklungen
Immunologie-Symposien	2-3 Konferenzen	Nanotechnologische Arzneimittelabgabe

Von Experten begutachtete medizinische Veröffentlichungen

Wissenschaftliche Publikationen dienen als wichtige Kommunikationskanäle für die Forschungsvalidierung.

• Durchschnittliche Veröffentlichungen pro Jahr: 2-3 Forschungsarbeiten
• Bevorzugte Zeitschriften: Nature Biotechnology, Cell, Journal of Immunology
• Kumulierte Zitate: Ungefähr 50–75 Zitate pro Jahr

Investor-Relations-Kommunikation

Tiziana pflegt über mehrere Plattformen eine transparente Kommunikation mit Investoren.

Kommunikationskanal	Häufigkeit	Reichweite
Vierteljährliche Gewinnaufrufe	4 Mal im Jahr	Ungefähr 75-100 institutionelle Anleger
Investorenpräsentationen	6-8 jährlich	Globale Investorenkonferenzen

Digitale Plattformen zur Forschungsverbreitung

Digitale Kanäle erhöhen die Sichtbarkeit und Zugänglichkeit der Forschung.

• Unternehmenswebsite: Detaillierte Forschungsaktualisierungen
• LinkedIn: Professionelles Networking
• ResearchGate: Engagement der wissenschaftlichen Gemeinschaft
• YouTube: Uploads von Forschungspräsentationen

Networking-Veranstaltungen für die Pharmaindustrie

Strategische Vernetzung unterstützt potenzielle Kooperationen und Partnerschaften.

Ereignistyp	Jährliche Teilnahme	Mögliche Ergebnisse
Biotech-Partnerschaftsforen	3-4 Veranstaltungen	Mögliche Lizenzvereinbarungen
Pharmazeutische Konferenzen	2-3 Konferenzen	Möglichkeiten der Forschungszusammenarbeit

Tiziana Life Sciences Ltd (TLSA) – Geschäftsmodell: Kundensegmente

Patientenpopulationen mit seltenen Krankheiten

Tiziana Life Sciences richtet sich an Patienten mit bestimmten seltenen Krankheiten und konzentriert sich auf:

Krankheitskategorie	Geschätzte Patientenpopulation	Marktpotenzial
Morbus Crohn	780.000 US-Patienten	Marktgröße: 5,8 Milliarden US-Dollar
Entzündliche Erkrankungen	1,2 Millionen potenzielle Patienten	Potenzieller Markt im Wert von 3,4 Milliarden US-Dollar

Märkte für onkologische Behandlungen

Zu den gezielten Onkologiesegmenten gehören:

• Seltene Krebspatientenpopulationen
• Märkte für die Behandlung von metastasiertem Krebs

Krebstyp	Jährliche Inzidenz	Marktwert
Seltene Krebsbehandlungen	250.000 neue Fälle jährlich	Marktsegment von 7,2 Milliarden US-Dollar

Medizinische Forschungseinrichtungen

Wichtige Kundensegmente von Forschungseinrichtungen:

Institutionstyp	Anzahl potenzieller Institutionen	Forschungsförderung
Akademische Forschungszentren	287 potenzielle Institutionen	Jährliches Forschungsbudget von 2,1 Milliarden US-Dollar
Angeschlossen an die National Institutes of Health	124 Forschungsnetzwerke	3,5 Milliarden US-Dollar Kooperationspotenzial

Spezialisierte Gesundheitsdienstleister

Zielsegmente von Gesundheitsdienstleistern:

• Spezialisierte Behandlungszentren
• Kliniken für Immunologie
• Onkologische Behandlungseinrichtungen

Anbietertyp	Gesamtausstattung	Mögliche Adoption
Spezialisierte Behandlungszentren	bundesweit 1.456	42 % potenzielle Marktdurchdringung

Pharmazeutische Entwicklungspartner

Ziele der pharmazeutischen Zusammenarbeit:

Partnerkategorie	Anzahl potenzieller Partner	Kollaborative Investition
Große Pharmaunternehmen	23 potenzielle Partner	Mögliche gemeinsame Investitionen in Höhe von 450 Millionen US-Dollar
Biotechnologie-Forschungsunternehmen	47 potenzielle Partner	280 Millionen US-Dollar potenzielle Gemeinschaftsfinanzierung

Tiziana Life Sciences Ltd (TLSA) – Geschäftsmodell: Kostenstruktur

Umfangreiche Kosten für klinische Studien

Für das Geschäftsjahr 2023 meldete Tiziana Life Sciences Ausgaben für klinische Studien in Höhe von 8,3 Millionen US-Dollar. Die laufende klinische Phase-2b-Studie des Unternehmens für TZLS-501 bei Morbus Crohn macht einen erheblichen Teil dieser Kosten aus.

Kategorie „Klinische Studie“.	Geschätzte jährliche Kosten
Phase-2b-Studie (TZLS-501)	5,2 Millionen US-Dollar
Präklinische Studien	1,8 Millionen US-Dollar
Patientenrekrutierung	1,3 Millionen US-Dollar

Forschungs- und Entwicklungsinvestitionen

Die F&E-Ausgaben für Tiziana Life Sciences beliefen sich im Jahr 2023 auf rund 12,5 Millionen US-Dollar und konzentrierten sich auf therapeutische Entwicklungen in den Bereichen Immunologie und Onkologie.

• Investition in die molekulare Forschungsplattform: 4,7 Millionen US-Dollar
• Optimierung von Medikamentenkandidaten: 3,2 Millionen US-Dollar
• Spezialisierte Forschungsausrüstung: 2,6 Millionen US-Dollar
• Kosten für externe Zusammenarbeit: 2 Millionen US-Dollar

Kosten für die Einhaltung gesetzlicher Vorschriften

Die Kosten für die Einhaltung gesetzlicher Vorschriften für 2023 wurden auf 1,6 Millionen US-Dollar geschätzt und decken die Einreichungsprozesse bei der FDA und der EMA ab.

Compliance-Kategorie	Kosten
Zulassungsgebühren	$750,000
Compliance-Dokumentation	$450,000
Externe Regulierungsberater	$400,000

Personal- und Fachkräfterekrutierung

Die gesamten Personalkosten erreichten im Jahr 2023 6,8 Millionen US-Dollar bei einer Belegschaft von 35 spezialisierten Mitarbeitern.

• Vergütung für leitende wissenschaftliche Mitarbeiter: 3,5 Millionen US-Dollar
• Gehälter für Forschungspersonal: 2,1 Millionen US-Dollar
• Rekrutierung und Schulung: 1,2 Millionen US-Dollar

Wartung von Technologie und Infrastruktur

Die Wartungskosten für Technologie und Infrastruktur beliefen sich im Jahr 2023 auf etwa 2,3 Millionen US-Dollar.

Kategorie „Infrastruktur“.	Jährliche Kosten
Wartung von Laborgeräten	1,2 Millionen US-Dollar
IT-Systeme und Cybersicherheit	$650,000
Overhead der Forschungseinrichtung	$450,000

Tiziana Life Sciences Ltd (TLSA) – Geschäftsmodell: Einnahmequellen

Mögliche zukünftige Arzneimittellizenzvereinbarungen

Bis zum Jahr 2024 verfügt Tiziana Life Sciences über keine bestätigten Arzneimittellizenzvereinbarungen. Die potenziellen Einnahmen des Unternehmens aus der Lizenzierung bleiben spekulativ.

Forschungsstipendien und Finanzierung

Finanzierungsquelle	Betrag (USD)	Jahr
NIH-Stipendium	$750,000	2023
Private Forschungsförderung	$1,200,000	2023

Potenzielle Einnahmen aus pharmazeutischen Partnerschaften

Bis 2024 gibt es keine bestätigten Einnahmen aus pharmazeutischen Partnerschaften.

Zukünftige Kommerzialisierung therapeutischer Produkte

• TZLS-501 (COVID-19-Therapeutikum): Möglicher Kommerzialisierungsweg
• TZLS-401 (Behandlung von Morbus Crohn): Laufende klinische Entwicklung

Monetarisierungsstrategien für geistiges Eigentum

Der Gesamtwert des geistigen Eigentumsportfolios wird auf geschätzt 3,5 Millionen Dollar ab 2024.

IP-Asset	Geschätzter Wert (USD)	Patentstatus
TZLS-501-Technologie	$1,500,000	Ausstehend
TZLS-401-Technologie	$2,000,000	Abgelegt

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.