Tiziana Life Sciences

What Tiziana Life Sciences does

Tiziana Life Sciences plc (NASDAQ: TLSA) is a clinical-stage biotechnology company developing intranasal immunomodulation therapies for neuroinflammatory and neurodegenerative diseases, incorporated in Bermuda with operational offices in Boston and London. The company's lead and only clinically advanced asset is intranasal foralumab (TZLS-401), the only fully human anti-CD3 monoclonal antibody in clinical development, which it positions as a non-invasive alternative to intravenous anti-CD3 delivery, stimulating T regulatory cells to dampen microglial activation and reduce neuroinflammation. The pipeline is anchored by Phase 2 programs in non-active Secondary Progressive Multiple Sclerosis (48-patient INFORM-MS trial with enrollment completed May 2026), Multiple System Atrophy (Phase 2a TILS-025 trial), and mild-to-moderate Alzheimer's Disease, supplemented by Expanded Access Programs, an ALS program accepted into the Healey MyMatch Program, and preclinical work in Long COVID and intracerebral hemorrhage.

The company generates no commercial revenue and operates as a research-driven biotech, conducting multicenter trials through partnerships with Brigham and Women's Hospital and Mass General Brigham under the scientific leadership of Dr. Howard Weiner, and drawing on NIH and ALS Association grant funding alongside periodic registered direct equity offerings. Insider ownership is concentrated, with Executive Chairman Gabriele Cerrone holding approximately 34.89% of issued shares and CEO Ivor Elrifi materially participating in recent raises. Patent protection on the foralumab composition, formulation, and indication space extends to 2040. Revenue mechanics are pre-commercial: future value creation depends on Phase 2/3 readouts (MS topline expected late Q3/early Q4 2026), potential licensing deals, and the planned spin-out of the second asset TZLS-501 (anti-IL-6 receptor mAb) into a separate publicly traded entity.

Name

Tiziana Life Sciences

Legal name

Tiziana Life Sciences plc

Website

https://tizianalifesciences.com

Company type

Public

Founded year

2013

Operating status

Operating

Headcount range

11–50 employees

Short description

Tiziana Life Sciences is a clinical-stage biotechnology company developing intranasal foralumab, the only fully human anti-CD3 monoclonal antibody in clinical development, for neuroinflammatory and neurodegenerative diseases including MS, Alzheimer's, MSA, and ALS.

Ownership category

akta.pro rank

Product category

Clinical-stage Biopharmaceuticals (Neuroimmunology)

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)

akta.pro primary industry

Monoclonal Antibody Therapeutics (mAbs) (HLAAAAAA)

akta.pro secondary industries

Neurology & CNS Specialty Pharmaceuticals (HLAIACAC), Immunology & Autoimmune Specialty Pharmaceuticals (HLAIACAB), Rare Immunology, Autoimmune & Autoinflammatory Therapies (HLAIAIAE)

Keywords

• Intranasal immunotherapy
• Monoclonal antibody therapy
• Neuroinflammatory disease treatment
• Biopharmaceutical drug development
• Clinical stage biotechnology

Headquarters

HQ city

London

HQ country

United Kingdom

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations

Revenue model

1. Biopharmaceutical Development: Pre-revenue clinical-stage biopharmaceutical company. Developing breakthrough therapies for neuroinflammatory and neurodegenerative diseases. No commercial products yet - all candidates are in clinical development stages.
2. Potential Future Licensing/Spinout - TZLS-501: Company announced plans to spin out its anti-IL-6 receptor monoclonal antibody TZLS-501 into a separate publicly traded company, citing increased industry interest exemplified by Novartis' recent acquisition of Tourmaline Bio. This represents potential future licensing or spinout revenue stream.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels4 records

Core offering

Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing intranasal foralumab (TZLS-401), the only fully human anti-CD3 monoclonal antibody in clinical development, for neuroinflammatory and neurodegenerative diseases including non-active Secondary Progressive Multiple Sclerosis, Multiple System Atrophy, Alzheimer's Disease, and ALS. The company also develops an anti-IL-6 receptor monoclonal antibody (TZLS-501) for lung diseases and is exploring milciclib in oncology.

Differentiator

Problem solved

Functional benefit

Products and services

• Intranasal Foralumab (TZLS-401) Intranasal Foralumab (TZLS-401) is the only fully human anti-CD3 monoclonal antibody in clinical development, delivered via Tiziana's proprietary intranasal platform to stimulate T regulatory cells and reduce neuroinflammation. It is being developed for non-active Secondary Progressive Multiple Sclerosis, Multiple System Atrophy, Alzheimer's Disease, ALS, Long COVID, and other neuroinflammatory indications. Patents covering composition, formulation, and indications are protected through 2040.
• Anti-IL-6 Receptor Monoclonal Antibody (TZLS-501) Anti-IL-6 Receptor Monoclonal Antibody (TZLS-501) is a fully human monoclonal antibody targeting the receptor for IL-6, being developed as a potential treatment for lung diseases and being positioned for spinout into a separate publicly traded company.
• Milciclib Milciclib is being explored by Tiziana in a combination study with gemcitabine in NSCLC subjects with associated pan-KRAS-positive mutations.

Quantifiable outcome

• 83% of patients (5 of 6) showed reduction in microglial PET signal after 3 and 6 months of treatment
• +4 more outcomes

Named customers3 records

Segments2 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Three partnerships are on record, tiered supporting and core.

• Yale UniversitysupportingStrategic or Co-development Partner · 16 April 2026Collaborated with Yale University researchers on preclinical data for Long COVID study. Research demonstrated that intranasal foralumab reduced neuroinflammation and improved cognitive function in mouse model of Long COVID.
• Brigham and Women's HospitalcoreStrategic or Co-development Partner · 25 November 2025Primary research partner conducting multiple clinical trials including Phase 2a na-SPMS trial (INFORM-MS), Phase 2 MSA trial (TILS-025), and Expanded Access Programs for Alzheimer's disease. Led by Dr. Howard Weiner and Dr. Tanuja Chitnis. Founded by researchers with decades of experience in neuroinflammatory diseases.
• Mass General BrighamcoreStrategic or Co-development Partner · 25 November 2025Major healthcare system overseeing clinical trial sites. Phase 2 ALS trial accepted into Healey ALS MyMatch Program at Mass General Brigham. Multiple hospitals within network serve as clinical trial sites.

Scale indicators8 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Anavex Life Sciences: Small-cap clinical-stage biotech focused on neurodegenerative diseases including Alzheimer's and Rett syndrome. Directly comparable to Tiziana in size, stage, indication overlap, and pre-revenue clinical development model.
• BioXcel Therapeutics: Clinical-stage biotech developing neuroinflammation and immunology therapies. Comparable in immunomodulation mechanism, small-cap clinical structure, and CNS indication focus.
• Prothena Corporation: Clinical-stage biotech developing monoclonal antibody therapies for neurodegenerative diseases including Parkinson's and Alzheimer's. Comparable in biologics platform, neuro focus, and pipeline-driven small-cap profile.
• Sage Therapeutics: CNS-focused biotech developing therapies for neurological disorders including multiple sclerosis. Comparable in neuro-focused pipeline, monoclonal antibody/biologics development, and small-cap clinical-stage structure.
• Voyager Therapeutics: Clinical-stage biotech developing gene therapy and antibody therapeutics for neurological diseases including Alzheimer's and ALS. Comparable in CNS indication focus and clinical-stage development model.
• Cassava Sciences: Clinical-stage biotech developing simufilam for Alzheimer's disease. Closely comparable in market cap, single-asset narrative, Phase 2/3 readout catalysts, and small-cap neurodegenerative focus.
• Denali Therapeutics: Clinical-stage biotech developing therapeutics for neurodegenerative diseases including Parkinson's, Alzheimer's, and ALS. Comparable in neuroimmunology pipeline, biologics approach, and multi-indication strategy.
• AC Immune SA: Clinical-stage biotech developing therapeutics and diagnostics for neurodegenerative diseases. Comparable in anti-amyloid and neuroinflammation focus, biologics platform, and partnership-driven clinical development model.
• Atara Biotherapeutics: Clinical-stage biotech developing T-cell and monoclonal antibody immunotherapies. Comparable in biologics platform, immunomodulation mechanism, and MS/neuro indications.
• Annexon, Inc. Clinical-stage biotech developing complement-mediated neuroinflammation therapeutics for neurodegenerative diseases. Directly comparable in neuroinflammatory mechanism, Phase 2 stage, and indication overlap (MS, ALS, Alzheimer's).

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xtwitter.com/tizianals
• LinkedInlinkedin.com/company/tiziana-life-sciences
• Facebookfacebook.com/tizianalifesciences

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds6 records

Investors2 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments1 record

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Tiziana Life Sciences