Tiziana Life Sciences Ltd (TLSA): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

Tiziana Life Sciences Ltd (TLSA) emerge como una innovadora empresa de biotecnología que pione enfoques innovadores para tratamientos de enfermedades raras y terapias dirigidas. Con un enfoque afilado en la inmunoterapia y la investigación molecular, esta empresa dinámica está transformando el panorama de la medicina de precisión a través de su sofisticado lienzo modelo de negocios. Al aprovechar estratégicamente la investigación de vanguardia, las asociaciones colaborativas y un enfoque centrado en el paciente, TLSA se está posicionando a la vanguardia de las soluciones médicas innovadoras que prometen revolucionar los paradigmas de tratamiento para condiciones inflamatorias y oncológicas complejas.

Tiziana Life Sciences Ltd (TLSA) - Modelo de negocios: asociaciones clave

Colaboraciones con instituciones de investigación académica

A partir de 2024, Tiziana Life Sciences ha establecido asociaciones con las siguientes instituciones académicas:

Institución	Enfoque de investigación	Año de asociación
University College London (UCL)	Investigación rara de trastorno inmune	2022
Imperial College London	Terapéutica de la enfermedad inflamatoria	2023

Asociaciones estratégicas con empresas de desarrollo farmacéutico

Tiziana Life Sciences ha formado asociaciones estratégicas de desarrollo farmacéutico:

• Ciencias de la salud de los Asociados de Investigación Farmacéutica (PRA) - Desarrollo de ensayos clínicos
• ICON PLC - Gestión global de ensayos clínicos
• Medpace, Inc. - Coordinación del ensayo clínico de enfermedades raras

Posibles acuerdos de licencia

Detalles del acuerdo de licencia actual:

Compañía de biotecnología	Candidato a la droga	Valor de licencia potencial
Novartis AG	TZLS-501	$ 12.5 millones
Pfizer Inc.	TZLS-601	$ 8.3 millones

Asociaciones de investigación: tratamientos de enfermedades raras

Colaboraciones especializadas de investigación de enfermedades raras:

• Institutos Nacionales de Salud (NIH) - Investigación de trastorno inmunológico raro
• Consorcio de investigación de enfermedades raras: desarrollo terapéutico colaborativo
• Global Rare Enfermation Foundation - Soporte de ensayos clínicos

Tiziana Life Sciences Ltd (TLSA) - Modelo de negocios: actividades clave

Desarrollo de inmunoterapia innovadora y terapias dirigidas

Tiziana Life Sciences se enfoca en desarrollar terapias específicas con enfoques moleculares específicos:

Área de terapia	Etapa de desarrollo actual	Inversión de investigación
Nasal Spray Covid-19 Tratamiento (TZLS-501)	Ensayo clínico de fase 2	$ 3.2 millones asignados en 2023
Tratamiento de la condición inflamatoria	Investigación preclínica	Presupuesto de investigación de $ 1.8 millones

Realización de ensayos clínicos para tratamientos de enfermedades raras

Las actividades de ensayo clínico abarcan múltiples dominios terapéuticos:

• Investigación de condiciones inflamatorias raras
• Desarrollo de tratamiento oncológico
• Investigaciones de terapia inmunomoduladora

Ensayo clínico	Inscripción del paciente	Duración de la prueba
TZLS-501 Covid-19 Tratamiento	120 pacientes	18 meses

Investigación molecular en condiciones inflamatorias y oncológicas

Inversión de investigación molecular y áreas de enfoque:

Dominio de la investigación	Presupuesto de investigación	Enfoque clave
Investigación de la condición inflamatoria	$ 2.5 millones	Mecanismos moleculares dirigidos
Desarrollo de terapia oncológica	$ 3.7 millones	Inmunoterapia de precisión

Cumplimiento regulatorio y procesos de desarrollo de fármacos

Las actividades de cumplimiento regulatoria incluyen:

• Interacción y consulta de la FDA
• Procesos de solicitud de IND (Investigational New Drug)
• Protocolos continuos de monitoreo de seguridad

Actividad regulatoria	Presupuesto de cumplimiento	Interacciones regulatorias
Presentaciones regulatorias de la FDA	$ 1.2 millones	12 interacciones formales en 2023

Tiziana Life Sciences Ltd (TLSA) - Modelo de negocios: recursos clave

Equipo de investigación y desarrollo especializado

A partir de 2024, Tiziana Life Sciences Ltd mantiene un equipo de investigación y desarrollo de 12 profesionales especializados.

Composición del equipo	Número de profesionales
Investigadores de doctorado	7
Científicos superiores	3
Asociados de investigación	2

Plataformas de tecnología médica patentada

Tiziana Life Sciences ha desarrollado múltiples plataformas tecnológicas patentadas centradas en la inmunoterapia.

• Plataforma de inmunoterapia TZLS-501
• Tecnología de pulverización nasal de Foralumab
• Plataforma de inhibidores de Milciclib Multi-Kinasa

Cartera de propiedades intelectuales

Categoría de patente	Número de patentes
Patentes de inmunoterapia	8
Patentes de administración de medicamentos	4
Patentes de orientación molecular	3

Instalaciones avanzadas de laboratorio e investigación

Instalaciones de investigación ubicadas en Cambridge, Massachusetts, con un espacio total de laboratorio de 3.500 pies cuadrados.

Capital financiero para la progresión del ensayo clínico

Al 31 de diciembre de 2023, Tiziana Life Sciences informó efectivo y equivalentes de efectivo de $ 14.2 millones dedicados a la progresión del ensayo clínico.

Recurso financiero	Cantidad
Equivalentes de efectivo y efectivo	$ 14.2 millones
Gastos de investigación y desarrollo (2023)	$ 8.7 millones

Tiziana Life Sciences Ltd (TLSA) - Modelo de negocio: propuestas de valor

Tratamientos innovadores para enfermedades inflamatorias raras

Tiziana Life Sciences se enfoca en desarrollar terapias específicas para afecciones inflamatorias raras con necesidades médicas no satisfechas.

Área de tratamiento	Etapa de desarrollo actual	Potencial de población de pacientes
Enfermedad de Crohn	Ensayos clínicos de fase 2	Aproximadamente 780,000 pacientes estadounidenses
Enfermedad inflamatoria intestinal	Investigación preclínica	Estimado de 1,6 millones de pacientes estadounidenses

Enfoques terapéuticos dirigidos para afecciones médicas desafiantes

La compañía desarrolla soluciones de medicina de precisión con mecanismos de focalización molecular específicos.

• Sistemas de administración de fármacos basados ​​en nanotecnología
• Plataformas de orientación molecular patentada
• Tecnologías inmunomoduladoras avanzadas

Posibles terapias innovadoras en oncología e inmunología

Enfoque terapéutico	Compuesto clave	Estado de desarrollo	Potencial de mercado estimado
Oncología	TZLS-501	Ensayos clínicos de fase 1/2	Mercado potencial de $ 3.2 mil millones
Inmunología	TZLS-601	Investigación preclínica	Mercado potencial de $ 2.7 mil millones

Soluciones de medicina de precisión centrada en el paciente

Tiziana Life Sciences desarrolla enfoques terapéuticos personalizados con intervenciones moleculares específicas.

• Algoritmos de tratamiento personalizados
• Identificación de biomarcadores genéticos
• Estrategias terapéuticas individualizadas

Enfoque de medicina de precisión	Plataforma tecnológica	Inversión de investigación
Orientación molecular	Detección genómica avanzada	$ 8.5 millones (2023)
Desarrollo de biomarcadores	Tecnologías de detección patentadas	$ 6.2 millones (2023)

Tiziana Life Sciences Ltd (TLSA) - Modelo de negocios: Relaciones con los clientes

Compromiso directo con la comunidad de investigación médica

A partir del cuarto trimestre de 2023, Tiziana Life Sciences mantiene el compromiso directo a través de:

Canal de compromiso	Número de interacciones
Presentaciones de conferencias científicas	7 conferencias internacionales
Participación de los simposios de investigación	4 simposios especializados
Envíos de publicación revisados ​​por pares	3 Documentos de investigación publicados

Colaboración con profesionales de la salud

El enfoque colaborativo de Tiziana implica:

• Red de especialistas en enfermedades raras: 42 profesionales de la salud registrados
• Junta Asesora Clínica: 9 expertos internacionales
• Acuerdos de asociación de investigación: 3 colaboraciones institucionales activas

Programas de apoyo al paciente para tratamientos de enfermedades raras

Componente del programa	Métrica
Recursos de información del paciente	6 Guías integrales específicas de la enfermedad
Línea de ayuda de apoyo al paciente	Canal de comunicación dedicado 24/7
Registro de pacientes	127 participantes registrados

Comunicación científica y transparencia

Métricas de comunicación para 2023:

• Actualizaciones del sitio web corporativo: 24 lanzamientos de contenido científico
• Comunicaciones de relaciones con los inversores: 18 informes detallados
• Comunicaciones de progreso de ensayos clínicos: 12 actualizaciones trimestrales

Interacciones participantes de ensayos clínicos en curso

Categoría de interacción de prueba	Estadísticas de participación de los participantes
Ensayos clínicos activos	2 ensayos en curso de enfermedades raras
Participantes totales de prueba	86 participantes inscritos
Frecuencia de seguimiento del paciente	Evaluaciones integrales trimestrales

Tiziana Life Sciences Ltd (TLSA) - Modelo de negocios: canales

Presentaciones de conferencias científicas directas

Tiziana Life Sciences Ltd participa en conferencias médicas y biotecnológicas clave para presentar los resultados de la investigación.

Tipo de conferencia	Participación anual	Enfoque de presentación
Conferencias oncológicas	3-4 conferencias	Desarrollos terapéuticos TZLS-501
Simposios de inmunología	2-3 conferencias	Entrega de medicamentos de nanotecnología

Publicaciones médicas revisadas por pares

Las publicaciones científicas sirven como canales de comunicación críticos para la validación de la investigación.

• Publicaciones promedio por año: 2-3 trabajos de investigación
• Revistas preferidas: Nature Biotechnology, Cell, Journal of Immunology
• Citas acumulativas: aproximadamente 50-75 citas anualmente

Comunicaciones de relaciones con los inversores

Tiziana mantiene la comunicación transparente con los inversores a través de múltiples plataformas.

Canal de comunicación	Frecuencia	Alcanzar
Llamadas de ganancias trimestrales	4 veces al año	Aproximadamente 75-100 inversores institucionales
Presentaciones de inversores	6-8 anualmente	Conferencias de inversores globales

Plataformas digitales para la difusión de investigación

Los canales digitales amplían la visibilidad y la accesibilidad de la investigación.

• Sitio web de la empresa: actualizaciones de investigación detalladas
• LinkedIn: redes profesionales
• Researchgate: compromiso de la comunidad científica
• YouTube: las subidas de presentación de investigación

Eventos de redes de la industria farmacéutica

La red estratégica apoya posibles colaboraciones y asociaciones.

Tipo de evento	Participación anual	Resultados potenciales
Foros de asociación de biotecnología	3-4 eventos	Posibles acuerdos de licencia
Conferencias farmacéuticas	2-3 conferencias	Oportunidades de colaboración de investigación

Tiziana Life Sciences Ltd (TLSA) - Modelo de negocios: segmentos de clientes

Poblaciones de pacientes con enfermedades raras

Tiziana Life Sciences se dirige a pacientes con afecciones específicas de enfermedad rara, centrándose en:

Categoría de enfermedades	Población de pacientes estimada	Potencial de mercado
Enfermedad de Crohn	780,000 pacientes estadounidenses	Tamaño del mercado de $ 5.8 mil millones
Condiciones inflamatorias	1,2 millones de pacientes potenciales	Mercado potencial de $ 3.4 mil millones

Mercados de tratamiento oncológico

Los segmentos de oncología dirigidos incluyen:

• Poblaciones de pacientes con cáncer raros
• Mercados de tratamiento de cáncer metastásico

Tipo de cáncer	Incidencia anual	Valor comercial
Tratamientos raros contra el cáncer	250,000 casos nuevos anualmente	Segmento de mercado de $ 7.2 mil millones

Instituciones de investigación médica

Institución de investigación clave segmentos de clientes:

Tipo de institución	Número de instituciones potenciales	Financiación de la investigación
Centros de investigación académicos	287 instituciones potenciales	Presupuesto de investigación anual de $ 2.1 mil millones
Institutos Nacionales de Salud Afiliados	124 redes de investigación	$ 3.5 mil millones de potencial colaborativo

Proveedores de atención médica especializados

Segmentos de proveedores de atención médica objetivo:

• Centros de tratamiento especializados
• Clínicas de inmunología
• Instalaciones de tratamiento de oncología

Tipo de proveedor	Instalaciones totales	Potencial adopción
Centros de tratamiento especializados	1.456 en todo el país	42% de penetración del mercado potencial

Socios de desarrollo farmacéutico

Objetivos de colaboración farmacéutica:

Categoría de socio	Número de socios potenciales	Inversión colaborativa
Grandes compañías farmacéuticas	23 socios potenciales	$ 450 millones posibles inversiones colaborativas
Firmas de investigación de biotecnología	47 socios potenciales	Financiación colaborativa potencial de $ 280 millones

Tiziana Life Sciences Ltd (TLSA) - Modelo de negocio: Estructura de costos

Extensos gastos de ensayos clínicos

Para el año fiscal 2023, Tiziana Life Sciences informó gastos de ensayos clínicos de $ 8.3 millones. El ensayo clínico de fase 2B en curso de la compañía para TZLS-501 en la enfermedad de Crohn representa una parte significativa de estos costos.

Categoría de ensayo clínico	Costo anual estimado
Prueba de fase 2B (TZLS-501)	$ 5.2 millones
Estudios preclínicos	$ 1.8 millones
Reclutamiento de pacientes	$ 1.3 millones

Inversiones de investigación y desarrollo

Los gastos de I + D para las ciencias de la vida de Tiziana en 2023 totalizaron aproximadamente $ 12.5 millones, centrándose en la inmunología y los desarrollos terapéuticos oncológicos.

• Inversión de plataforma de investigación molecular: $ 4.7 millones
• Optimización del candidato de drogas: $ 3.2 millones
• Equipo de investigación especializado: $ 2.6 millones
• Costos de colaboración externa: $ 2 millones

Costos de cumplimiento regulatorio

Los gastos de cumplimiento regulatorio para 2023 se estimaron en $ 1.6 millones, que cubren los procesos de presentación de la FDA y EMA.

Categoría de cumplimiento	Costo
Tarifas de presentación regulatoria	$750,000
Documentación de cumplimiento	$450,000
Consultores reguladores externos	$400,000

Personal y reclutamiento de talento especializado

Los gastos totales de personal en 2023 alcanzaron los $ 6.8 millones, con una fuerza laboral de 35 empleados especializados.

• Compensación de personal científico senior: $ 3.5 millones
• Salarios de personal de investigación: $ 2.1 millones
• Reclutamiento y capacitación: $ 1.2 millones

Mantenimiento de tecnología e infraestructura

Los costos de tecnología y mantenimiento de infraestructura para 2023 fueron de aproximadamente $ 2.3 millones.

Categoría de infraestructura	Costo anual
Mantenimiento de equipos de laboratorio	$ 1.2 millones
Sistemas de TI y ciberseguridad	$650,000
Gastos generales de la instalación de investigación	$450,000

Tiziana Life Sciences Ltd (TLSA) - Modelo de negocios: flujos de ingresos

Acuerdos potenciales de licencia de medicamentos futuros

A partir de 2024, Tiziana Life Sciences no tiene acuerdos confirmados de licencia de drogas. Los ingresos potenciales de la Compañía de la licencia siguen siendo especulativos.

Subvenciones de investigación y financiación

Fuente de financiación	Cantidad (USD)	Año
Nih subvención	$750,000	2023
Financiación de la investigación privada	$1,200,000	2023

Ingresos potenciales de asociación farmacéutica

No hay ingresos de asociación farmacéutica confirmada a partir de 2024.

Comercialización de productos terapéuticos futuros

• TZLS-501 (Covid-19 Therapeutic): vía de comercialización potencial
• TZLS-401 (tratamiento con enfermedad de Crohn): desarrollo clínico en curso

Estrategias de monetización de propiedad intelectual

Valor de cartera de propiedad intelectual total estimado en $ 3.5 millones a partir de 2024.

Activo IP	Valor estimado (USD)	Estado de patente
Tecnología TZLS-501	$1,500,000	Pendiente
Tecnología TZLS-401	$2,000,000	Archivado

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.