Tiziana Life Sciences Ltd · NASDAQ:TLSA
Tiziana Life Sciences — Investor Presentation (March 2025)
20 slides from Tiziana Life Sciences's investor presentation, March 2025
Slide 1: Intranasal Anti-CD3 mAb Therapy to Enable Breakthroughs in Neuroinflammatory and Neurodegenerative Diseases
Intranasal Anti-CD3 mAb Therapy to Enable Breakthroughs in Neuroinflammatory and Neurodegenerative Diseases
Slide 2: Foralumab is the Only Fully Human Anti-CD3 mAb in Clinical Trials
Foralumab is the Only Fully Human Anti-CD3 mAb in Clinical Trials Approved and Investigational CD3-specific Monoclonal Antibodies OKT3 Teplizumab†† Otelixizumab Foralumab Muromonab† IgG2a IgG1 IgG2 IgG1 Fully Murine Chimeric & Humanized Humanized Fully Human † Approved by the FDA for solid organ tra
Slide 3: 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 4: Foralumab Development Program History and Next Steps
Foralumab Development Program History and Next Steps Gathered safety & efficacy evidence via Expanded Access Program before advancing to Phase 2a Phase 1 27 healthy volunteers 10ug, 50ug, or 250ug studied Desired immune effects of nasal foralumab occur at the 50ug dose No safety concerns Proof Of Co
Slide 5: Intranasal Foralumab Reduces Neuroinflammation
Intranasal Foralumab Reduces Neuroinflammation EA6 5
Slide 6: Non-active Secondary Progressive Multiple Sclerosis (na-SPMS)
Non-active Secondary Progressive Multiple Sclerosis (na-SPMS)
Slide 7: Non-Active Secondary Progressive Multiple Sclerosis is an Attractive Market
Non-Active Secondary Progressive Multiple Sclerosis is an Attractive Market Patients are treated with approved Approximately 25% of Relapsing disease-modifying therapies (DMTs) Remitting MS (RRMS) patients are as standard of care for Active-SPMS estimated to progress to SPMS* But there are currently
Slide 8: Improvement or Stabilization in all na-SPMS Expanded Access Patients
Improvement or Stabilization in all na-SPMS Expanded Access Patients First Ten Patients • All patients received at least 6-months of treatment • Clinical improvements or stabilization was reported across the entire group • Improvements measured by Fatigue scores (MFIS), T25FW, EDSS, and Pyramidal Sc
Slide 9: Patient EA2 Clinical Snapshot
Patient EA2 Clinical Snapshot 2018 – 2021 2022 2023 Enrolled in the intranasal foralumab Expanded EA2 returned to work and has been working Patient’s non-active SPMS disability progressed Access Program (EAP) in January 2022 since January, now full-time EDSS worsened from 3.5 to 6.0 despite EA2 able
Slide 10: 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 11: Early Symptomatic & Moderate Alzheimer's Disease (AD)
Early Symptomatic & Moderate Alzheimer’s Disease (AD)
Slide 12: 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 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 H1
Slide 16: ALS: Phase 2a Study Design
ALS: Phase 2a Study Design: Intranasal Foralumab Dosing (n=20); Randomized, Open Label, Reader Blinded, Parallel Group 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 Wee
Slide 17: 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 End of 2025 Alzheimer’s Disease (Mild) Expected 1H Phase 2 Study 2025 Start Enteric Coated Oral Capsules for Crohn’s
Slide 18: Semaglutide & Anti-CD3 Combination Study
Semaglutite & Anti-CD3 Combination Study
Slide 19: Nasal Anti-CD3 Enhances Semaglutide-Mediated Liver Homeostasis In DIO Mice
Nasal Anti-CD3 Enhances Semaglutide-Mediated Liver Homeostasis In DIO Mice DIO model: early MAFLD development Start 2 weeks aCD3 (3x/wk) then combined with daily Semaglutide (Sema) LD or HD for 4 weeks 3-5 mice per group PBS= Placebo, HFD= High Fat Diet, LD= Low Dose, HD= High Dose, Sema= Semaglutid
Slide 20: 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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