Tiziana Life Sciences Ltd (TLSA): Modelo de Negócios Canvas [Jan-2025 Atualizado]

A Tiziana Life Sciences Ltd (TLSA) surge como uma empresa inovadora de biotecnologia, pioneira abordagens inovadoras para tratamentos de doenças raras e terapias direcionadas. Com um foco nítido em imunoterapia e pesquisa molecular, essa empresa dinâmica está transformando o cenário da medicina de precisão por meio de sua sofisticada tela de modelo de negócios. Ao alavancar estrategicamente pesquisas de ponta, parcerias colaborativas e uma abordagem centrada no paciente, a TLSA está se posicionando na vanguarda de soluções médicas inovadoras que prometem revolucionar os paradigmas de tratamento para condições inflamatórias e oncológicas complexas.

Tiziana Life Sciences Ltd (TLSA) - Modelo de negócios: Parcerias -chave

Colaborações com instituições de pesquisa acadêmica

A partir de 2024, a Tiziana Life Sciences estabeleceu parcerias com as seguintes instituições acadêmicas:

Instituição	Foco na pesquisa	Ano de parceria
University College London (UCL)	Pesquisa de transtorno imune raro	2022
Imperial College London	Terapêutica de doença inflamatória	2023

Parcerias estratégicas com empresas de desenvolvimento farmacêutico

A Tiziana Life Sciences formou parcerias estratégicas de desenvolvimento farmacêutico:

• Pesquisa farmacêutica Associates (PRA) Health Sciences - Desenvolvimento de ensaios clínicos
• ICON PLC - Gerenciamento global de ensaios clínicos
• Medpace, Inc. - Coordenação de ensaios clínicos de doenças raras

Acordos de licenciamento em potencial

Detalhes atuais do contrato de licenciamento:

Companhia de Biotecnologia	Candidato a drogas	Valor potencial de licenciamento
Novartis AG	TZLS-501	US $ 12,5 milhões
Pfizer Inc.	TZLS-601	US $ 8,3 milhões

Parcerias de pesquisa - tratamentos de doenças raras

Colaborações especializadas de pesquisa de doenças raras:

• Institutos Nacionais de Saúde (NIH) - Pesquisa de Transtorno Imunológico Raro
• Consórcio de pesquisa de doenças raras - Desenvolvimento terapêutico colaborativo
• Fundação Global de Doenças Raras - Suporte de Ensaios Clínicos

Tiziana Life Sciences Ltd (TLSA) - Modelo de negócios: Atividades -chave

Desenvolvendo imunoterapia inovadora e terapias direcionadas

Tiziana Life Sciences se concentra no desenvolvimento de terapias direcionadas com abordagens moleculares específicas:

Área de terapia	Estágio de desenvolvimento atual	Investimento em pesquisa
Tratamento nasal com spray covid-19 (TZLS-501)	Ensaio clínico de fase 2	US $ 3,2 milhões alocados em 2023
Tratamento da condição inflamatória	Pesquisa pré -clínica	Orçamento de pesquisa de US $ 1,8 milhão

Realização de ensaios clínicos para tratamentos de doenças raras

As atividades de ensaios clínicos abrangem vários domínios terapêuticos:

• Pesquisa de condições inflamatórias raras
• Desenvolvimento de tratamento oncológico
• Investigações de terapia imunomoduladora

Ensaio clínico	Inscrição do paciente	Duração do teste
Tratamento TZLS-501 COVID-19	120 pacientes	18 meses

Pesquisa molecular em condições inflamatórias e oncológicas

Molecular Research Investment and Focus Areas:

Domínio de pesquisa	Orçamento de pesquisa	Foco principal
Pesquisa de condição inflamatória	US $ 2,5 milhões	Mecanismos moleculares direcionados
Desenvolvimento da terapia oncológica	US $ 3,7 milhões	Imunoterapia com precisão

Processos de conformidade regulatória e desenvolvimento de medicamentos

As atividades de conformidade regulatória incluem:

• Interação e consulta da FDA
• IND (Processos de aplicação de medicamentos novos para investigação)
• Protocolos de monitoramento de segurança contínua

Atividade regulatória	Orçamento de conformidade	Interações regulatórias
Submissões regulatórias da FDA	US $ 1,2 milhão	12 interações formais em 2023

Tiziana Life Sciences Ltd (TLSA) - Modelo de negócios: Recursos -chave

Equipe especializada de pesquisa e desenvolvimento

A partir de 2024, a Tiziana Life Sciences Ltd mantém uma equipe de pesquisa e desenvolvimento de 12 profissionais especializados.

Composição da equipe	Número de profissionais
Pesquisadores de doutorado	7
Cientistas seniores	3
Associados de pesquisa	2

Plataformas proprietárias de tecnologia médica

A Tiziana Life Sciences desenvolveu várias plataformas de tecnologia proprietárias focadas na imunoterapia.

• Plataforma de imunoterapia TZLS-501
• Tecnologia de spray nasal do Foralumab
• Milciclib Multi-quinase Plataforma

Portfólio de propriedade intelectual

Categoria de patentes	Número de patentes
Patentes de imunoterapia	8
Patentes de entrega de medicamentos	4
Patentes de direcionamento molecular	3

Instalações avançadas de laboratório e pesquisa

Instalações de pesquisa localizadas em Cambridge, Massachusetts, com espaço total de laboratório de 3.500 pés quadrados.

Capital financeiro para progressão do ensaio clínico

Em 31 de dezembro de 2023, a Tiziana Life Sciences relatou dinheiro e equivalentes a dinheiro de US $ 14,2 milhões dedicados à progressão do ensaio clínico.

Recurso financeiro	Quantia
Caixa e equivalentes de dinheiro	US $ 14,2 milhões
Despesas de pesquisa e desenvolvimento (2023)	US $ 8,7 milhões

Tiziana Life Sciences Ltd (TLSA) - Modelo de Negócios: Proposições de Valor

Tratamentos inovadores para doenças inflamatórias raras

A Tiziana Life Sciences se concentra no desenvolvimento de terapias direcionadas para condições inflamatórias raras com necessidades médicas não atendidas.

Área de tratamento	Estágio de desenvolvimento atual	Potencial população de pacientes
Doença de Crohn	Ensaios clínicos de fase 2	Aproximadamente 780.000 pacientes nos EUA
Doença inflamatória intestinal	Pesquisa pré-clínica	Estimado 1,6 milhão de pacientes nos EUA

Abordagens terapêuticas direcionadas para desafiar condições médicas

A empresa desenvolve soluções de medicina de precisão com mecanismos específicos de direcionamento molecular.

• Sistemas de administração de medicamentos baseados em nanotecnologia
• Plataformas de segmentação molecular proprietária
• Tecnologias imunomoduladoras avançadas

Terapias potenciais inovadoras em oncologia e imunologia

Foco terapêutico	Composto chave	Status de desenvolvimento	Potencial estimado de mercado
Oncologia	TZLS-501	Fase 1/2 ensaios clínicos	Mercado potencial de US $ 3,2 bilhões
Imunologia	TZLS-601	Pesquisa pré-clínica	Mercado potencial de US $ 2,7 bilhões

Soluções de medicina de precisão focadas no paciente

A Tiziana Life Sciences desenvolve abordagens terapêuticas personalizadas com intervenções moleculares direcionadas.

• Algoritmos de tratamento personalizado
• Identificação genética de biomarcadores
• Estratégias terapêuticas individualizadas

Abordagem de medicina de precisão	Plataforma tecnológica	Investimento em pesquisa
Direcionamento molecular	Triagem genômica avançada	US $ 8,5 milhões (2023)
Desenvolvimento de Biomarcadores	Tecnologias de triagem proprietárias	US $ 6,2 milhões (2023)

Tiziana Life Sciences Ltd (TLSA) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com a comunidade de pesquisa médica

A partir do quarto trimestre 2023, a Tiziana Life Sciences mantém o envolvimento direto por meio de:

Canal de engajamento	Número de interações
Apresentações da conferência científica	7 Conferências Internacionais
Participação do Simpósias de Pesquisa	4 simpósios especializados
Envios de publicação revisados ​​por pares	3 trabalhos de pesquisa publicados

Colaboração com profissionais de saúde

A abordagem colaborativa de Tiziana envolve:

• Rede Especialista de Doenças Raras: 42 Profissionais de Saúde Registrados
• Conselho Consultivo Clínico: 9 Especialistas Internacionais
• Acordos de parceria de pesquisa: 3 colaborações institucionais ativas

Programas de apoio ao paciente para tratamentos de doenças raras

Componente do programa	Métricas
Recursos de informação do paciente	6 guias abrangentes específicos de doenças
Helpline de apoio ao paciente	Canal de comunicação dedicado 24/7
Registro de pacientes	127 participantes registrados

Comunicação científica e transparência

Métricas de comunicação para 2023:

• Atualizações do site corporativo: 24 liberações de conteúdo científico
• Comunicações de Relações com Investidores: 18 relatórios detalhados
• Comunicações de progresso do ensaio clínico: 12 atualizações trimestrais

Interações de participantes do ensaio clínico em andamento

Categoria de interação de teste	Estatísticas de engajamento dos participantes
Ensaios clínicos ativos	2 ensaios em andamento de doenças raras
TOTAL dos participantes do julgamento	86 participantes inscritos
Frequência de acompanhamento do paciente	Avaliações abrangentes trimestrais

Tiziana Life Sciences Ltd (TLSA) - Modelo de Negócios: Canais

Apresentações de conferências científicas diretas

A Tiziana Life Sciences Ltd participa das principais conferências médicas e de biotecnologia para apresentar os resultados da pesquisa.

Tipo de conferência	Participação anual	Foco de apresentação
Conferências de oncologia	3-4 Conferências	Desenvolvimentos terapêuticos TZLS-501
Simpósios de imunologia	2-3 Conferências	Nanotecnologia Entrega de medicamentos

Publicações médicas revisadas por pares

As publicações científicas servem como canais críticos de comunicação para a validação da pesquisa.

• Publicações médias por ano: 2-3 trabalhos de pesquisa
• Revistas preferidas: Biotecnologia da Natureza, Cell, Journal of Immunology
• Citações cumulativas: aproximadamente 50-75 citações anualmente

Comunicações de Relações com Investidores

Tiziana mantém uma comunicação transparente com os investidores por meio de várias plataformas.

Canal de comunicação	Freqüência	Alcançar
Chamadas de ganhos trimestrais	4 vezes por ano	Aproximadamente 75-100 investidores institucionais
Apresentações de investidores	6-8 anualmente	Conferências de investidores globais

Plataformas digitais para disseminação de pesquisa

Os canais digitais expandem a visibilidade e a acessibilidade da pesquisa.

• Site da empresa: atualizações detalhadas de pesquisa
• LinkedIn: Networking Professional
• ResearchGate: Engajamento da Comunidade Científica
• YouTube: Uploads de apresentação de pesquisa

Eventos de rede da indústria farmacêutica

A rede estratégica suporta possíveis colaborações e parcerias.

Tipo de evento	Participação anual	Resultados potenciais
Fóruns de parceria de biotecnologia	3-4 eventos	Acordos de licenciamento em potencial
Conferências farmacêuticas	2-3 Conferências	Oportunidades de colaboração de pesquisa

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

Populações de pacientes com doenças raras

Tiziana Life Sciences tem como alvo pacientes com condições específicas de doenças raras, com foco em:

Categoria de doença	População estimada de pacientes	Potencial de mercado
Doença de Crohn	780.000 pacientes nos EUA	Tamanho do mercado de US $ 5,8 bilhões
Condições inflamatórias	1,2 milhão de pacientes em potencial	Mercado potencial de US $ 3,4 bilhões

Mercados de tratamento de oncologia

Os segmentos de oncologia direcionados incluem:

• Populações raras de pacientes com câncer
• Mercados de tratamento de câncer metastático

Tipo de câncer	Incidência anual	Valor de mercado
Tratamentos raros do câncer	250.000 novos casos anualmente	Segmento de mercado de US $ 7,2 bilhões

Instituições de Pesquisa Médica

Principais segmentos de clientes da instituição de pesquisa:

Tipo de instituição	Número de instituições em potencial	Pesquisa financiamento
Centros de pesquisa acadêmica	287 instituições em potencial	US $ 2,1 bilhões no orçamento de pesquisa anual
Institutos Nacionais de Saúde afiliados	124 redes de pesquisa	Potencial colaborativo de US $ 3,5 bilhões

Provedores de assistência médica especializados

Segmentos de provedores de saúde -alvo:

• Centros de tratamento especializados
• Clínicas de imunologia
• Instalações de tratamento oncológicas

Tipo de provedor	Total de instalações	Adoção potencial
Centros de tratamento especializados	1.456 em todo o país	42% de penetração potencial de mercado

Parceiros de desenvolvimento farmacêutico

Metas de colaboração farmacêutica:

Categoria de parceiro	Número de parceiros em potencial	Investimento colaborativo
Grandes empresas farmacêuticas	23 parceiros em potencial	US $ 450 milhões em potenciais investimentos colaborativos
Empresas de pesquisa de biotecnologia	47 parceiros em potencial	US $ 280 milhões em potencial financiamento colaborativo

Tiziana Life Sciences Ltd (TLSA) - Modelo de negócios: Estrutura de custos

Extensas despesas de ensaio clínico

Para o ano fiscal de 2023, a Tiziana Life Sciences registrou despesas de ensaios clínicos de US $ 8,3 milhões. O ensaio clínico em andamento da Fase 2b da Companhia para TZLS-501 na doença de Crohn representa uma parcela significativa desses custos.

Categoria de ensaio clínico	Custo anual estimado
Ensaio de Fase 2b (TZLS-501)	US $ 5,2 milhões
Estudos pré -clínicos	US $ 1,8 milhão
Recrutamento de pacientes	US $ 1,3 milhão

Investimentos de pesquisa e desenvolvimento

As despesas de P&D para ciências da vida em Tiziana em 2023 totalizaram aproximadamente US $ 12,5 milhões, focando em desenvolvimentos terapêuticos de imunologia e oncologia.

• Investimento em plataforma de pesquisa molecular: US $ 4,7 milhões
• Otimização de candidatos a drogas: US $ 3,2 milhões
• Equipamento de pesquisa especializado: US $ 2,6 milhões
• Custos de colaboração externa: US $ 2 milhões

Custos de conformidade regulatória

As despesas de conformidade regulatória para 2023 foram estimadas em US $ 1,6 milhão, cobrindo os processos de envio da FDA e da EMA.

Categoria de conformidade	Custo
Taxas de arquivamento regulatório	$750,000
Documentação de conformidade	$450,000
Consultores regulatórios externos	$400,000

Pessoal e recrutamento especializado de talentos

O total de despesas de pessoal em 2023 atingiu US $ 6,8 milhões, com uma força de trabalho de 35 funcionários especializados.

• Compensação sênior da equipe científica: US $ 3,5 milhões
• Salários do pessoal de pesquisa: US $ 2,1 milhões
• Recrutamento e treinamento: US $ 1,2 milhão

Manutenção de tecnologia e infraestrutura

Os custos de manutenção de tecnologia e infraestrutura para 2023 foram de aproximadamente US $ 2,3 milhões.

Categoria de infraestrutura	Custo anual
Manutenção de equipamentos de laboratório	US $ 1,2 milhão
Sistemas de TI e segurança cibernética	$650,000
Instalação de pesquisa sobrecarga	$450,000

Tiziana Life Sciences Ltd (TLSA) - Modelo de negócios: fluxos de receita

Potenciais acordos futuros de licenciamento de medicamentos

A partir de 2024, a Tiziana Life Sciences não possui acordos de licenciamento de medicamentos confirmados. A receita potencial da empresa com o licenciamento permanece especulativa.

Bolsas de pesquisa e financiamento

Fonte de financiamento	Quantidade (USD)	Ano
NIH Grant	$750,000	2023
Financiamento de pesquisa privada	$1,200,000	2023

Potenciais receitas de parceria farmacêutica

Nenhuma receita de parceria farmacêutica confirmada a partir de 2024.

Futura comercialização terapêutica de produtos

• TZLS-501 (covid-19 terapêutico): Caminho potencial de comercialização
• TZLS-401 (tratamento da doença de Crohn): Desenvolvimento Clínico em andamento

Estratégias de monetização da propriedade intelectual

Valor da carteira total de propriedade intelectual estimada em US $ 3,5 milhões a partir de 2024.

Ativo IP	Valor estimado (USD)	Status de patente
Tecnologia TZLS-501	$1,500,000	Pendente
Tecnologia TZLS-401	$2,000,000	Arquivado

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.