Tiziana Life Sciences Ltd · NASDAQ:TLSA
Tiziana Life Sciences — Investor Presentation (September 2025)
18 slides from Tiziana Life Sciences's investor presentation, September 2025
Slide 1: Intranasal Fully Human Anti-CD3 mAb (Foralumab) Therapy
Intranasal Fully Human Anti-CD3 mAb (“FORALUMAB”) Therapy to Enable Breakthroughs in Neuroinflammatory and Neurodegenerative Diseases
Slide 2: Foralumab: Mechanism of Action
1 Foralumab: Intranasal Single dose Mechanism of Action1,2 Foralumab Patient inhales the antibody intranasally Binding of foralumab to the T-cell receptor complex in cervical lymph node Tregs are then created 2 Binding CD3/TCR complex BBB and activated Blood-Brain-Barrier Uptake T cell 3 These creat
Slide 3: Non-active Secondary Progressive Multiple Sclerosis (na-SPMS)
Non-active Secondary Progressive Multiple Sclerosis (na-SPMS)
Slide 4: Non-Active Secondary Progressive Multiple Sclerosis is an Attractive Market
Non-Active Secondary Progressive Multiple Sclerosis is an Attractive Market Approximately 25% of There are currently no effective Relapsing Remitting MS treatments for (RRMS) patients are estimated Non-Active (non-relapsing) SPMS to progress to SPMS* Secondary Progressive Multiple Global Multiple Sc
Slide 5: Intranasal Foralumab Reduces Neuroinflammation
Intranasal Foralumab Reduces Neuroinflammation EA6 5
Slide 6: Improvement or Stabilization in all na-SPMS Expanded Access Patients
Improvement or Stabilization in all na-SPMS Expanded Access Patients • Clinical improvements or stabilization was reported across the entire group, as measured by Fatigue scores (MFIS), T25FW, EDSS, or Pyramidal Scores • Fatigue scores improved in 7/10 patients • TSPO-PET shows significant reduction
Slide 7: Non-Active Secondary Progressive MS: Phase 2a Study Design
Non-Active Secondary Progressive MS: Phase 2a Study Design: Intranasal Foralumab Dosing (n=54); Double-Blind, Placebo-Controlled, 18 Patients Per Treatment Arm Primary Endpoint Baseline at 3 Months of Each Cycle = 3 Weeks / 4 cycles x 3 = 12 weeks Screening Treatment Week 1 Week 2 Week 3 Week 4 Week
Slide 8: Multiple System Atrophy (MSA)
Multiple System Atrophy (MSA)
Slide 9: Multiple System Atrophy (MSA) Phase 2a Clinical Trial
Multiple System Atrophy (MSA) Phase 2a Clinical Trial MSA is a rapidly progressive neurological disorder. It is caused by degeneration or atrophy (shrinking) of nerve cells in several (or multiple) areas of the brain. Classified as Orphan FDA Approved IND Q3 disease by the FDA 2025 No FDA approved F
Slide 10: Early Symptomatic & Moderate Alzheimer's Disease (AD)
Early Symptomatic & Moderate Alzheimer’s Disease (AD)
Slide 11: Alzheimer's Disease Program is Advancing and Equally Exciting
Alzheimer’s Disease Program is Advancing and Equally Exciting Awarded $4 Million Grant from National Institutes of Health (NIH), National Institute on Aging to Study Anti-CD3 in Alzheimer’s Disease Letter to Proceed received for IND to conduct a Phase 2 study of intranasal foralumab in Alzheimer’s d
Slide 12: Moderate Alzheimer's Disease Expanded Access Study
Moderate Alzheimer’s Disease Expanded Access Study • 78-Year-Old Moderate Alzheimer’s patient treated for 3 months with intranasal foralumab • PET Scan shows significant reduction of microglia activity following 3 months of treatment • Data presented at AD/PD in April 2025 • Data Published in the Jo
Slide 13: Early Symptomatic Alzheimer's Disease: Phase 2a Study Design
Early Symptomatic Alzheimer’s Disease: Phase 2a Study Design: Intranasal Foralumab Dosing (n=32); Double-Blind, Placebo-Controlled, 2 Clinical Sites Treatment Arms Per Site: 6 x 50mcg, 6 x 100mcg, 4 x Placebo. Primary Endpoint at 3 Months of Baseline Each Cycle = 3 Weeks / 4 cycles x 3 = 12 Week rea
Slide 14: Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Slide 15: ALS Phase 2 Study Supported by The ALS Association
ALS Phase 2 Study Supported by The ALS Association Grant Awarded from The ALS Association to Study Intranasal Foralumab in ALS patients in a 20 Patient, Dose Ranging, Phase 2 Clinical Trial Global Market size of $790m IND Filed March 2025 CARG of 5.8% from 2024-2030 Phase 2 trial planned to start H2
Slide 16: ALS: Phase 2a Study Design
ALS: Phase 2a Study Design: Intranasal Foralumab Dosing (n=20); Randomized, Placebo Controlled Trial Primary Endpoint Baseline Each Cycle = 3 Weeks / 4 cycles x 6 = 24 week readout at 6 Months of Screening Treatment Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Week 10 Week 11 Week
Slide 17: Intranasal Foralumab Pipeline
Intranasal Foralumab Pipeline Expanded Preclinical IND Phase 1 Access Phase 2 Phase 3 Program Non-Active Secondary Expecting Topline Progressive Multiple Data Sclerosis Phase 2 Study Q1 2026 Multiple System Atrophy Began dosing Aug (MSA) Phase 2 Study 2025 Alzheimer’s Disease (Mild) Expected 2H 2025
Slide 18: US and UK Headquarters Contact Details
US Headquarters (New York) Tiziana Life Science Ltd. 420 Lexington Avenue, Suite 2525 New York, NY 10170 UK Headquarters (London) Tiziana Life Sciences plc 14-15 Conduit Street London W1D 2XJ Investors: +44 (0)207 495 2379 info@tizianalifesciences.com
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