Tiziana Life Sciences Ltd · NASDAQ:TLSA
Tiziana Life Sciences — Investor Presentation (July 2025)
16 slides from Tiziana Life Sciences's investor presentation, July 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: Early Symptomatic & Moderate Alzheimer's Disease (AD)
Early Symptomatic & Moderate Alzheimer’s Disease (AD)
Slide 9: 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 10: 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 11: 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 12: Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Slide 13: 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 14: 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 15: Intranasal Foralumab Pipeline
Intranasal Foralumab Pipeline Expanded Preclinical IND Phase 1 Access Phase 2 Phase 3 Program Non-Active Secondary Expecting Progressive Multiple Topline Data Sclerosis Phase 2 Study Q1 2026 Alzheimer’s Disease (Mild) Expected 2H Phase 2 Study 2025 Start Enteric Coated Oral Capsules for Crohn’s Dise
Slide 16: 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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