Tiziana Life Sciences Ltd · NASDAQ:TLSA
Tiziana Life Sciences — Investor Presentation (September 2023)
24 slides from Tiziana Life Sciences's investor presentation, September 2023
Slide 1: Intranasal Anti-CD3 mAb Therapy to Enable Breakthroughs in Neuroinflammatory Disease
Intranasal Anti-CD3 mAb Therapy to Enable Breakthroughs in Neuroinflammatory Disease
Slide 2: Disclaimer and Forward-Looking Statement
Disclaimer and Forward-Looking Statement The content of this presentation has been prepared for the purpose of providing general information about, and an overview of, the Company and its business. It is not intended to be a complete review of all matters concerning the Company and nor has it been i
Slide 3: Investment Highlights
Investment Highlights Targeting the U.S. Lead program is in Validated MOA works MS Clinical data and Experienced scientific market for non-active SPMS across various publication in PNAS1 advisory board and neuroinflammatory neuroinflammatory management team that anti-CD3 antibody IND cleared and “ma
Slide 4: Lead Asset is Intranasal Foralumab
Lead Asset is Intranasal Foralumab Multiple administration routes of a proven systemic anti-inflammatory, patent protected until 2040 THERAPEUTIC AREA PRECLINICAL IND PHASE 1 PHASE 2 PHASE 3 COMMENTS Phase 2a expected to begin Non-active SPMS* 3Q 2023 IND clearance received 3Q Alzheimer’s 2023 FORAL
Slide 5: Lead Asset: Intranasal Foralumab
Lead Asset: Intranasal Foralumab The only fully human anti-CD3 monoclonal antibody in clinical studies
Slide 6: 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 7: Foralumab: Mechanism of Action
1 Intranasal Single dose Foralumab: Mechanism of Action Foralumab 1 Patient inhales the antibody intranasally 2 Binding of foralumab to the T-cell receptor complex 2 Binding CD3/TCR complex BBB Blood-Brain-Barrier 3 Creation and activation of Tregs Uptake T cell 3 4 Tregs will cross the blood brain
Slide 8: Publication in PNAS Characterized the Anti-Inflammatory Properties of Foralumab
Publication in Proceedings of National Academy of Sciences Characterized the Anti-Inflammatory Properties of Foralumab in MS and COVID-19 Patients Illustrates that the immunological basis of the mechanism of action for intranasal foralumab is based on increasing production of naïve-like T cells and
Slide 9: Foralumab: Clinical Proof of Concept for Intranasal Delivery in COVID-19
Foralumab: Clinical Proof of Concept for Intranasal Delivery First Demonstrated in Mild-to-Moderate COVID-19 CT Scan of Patients’ Lungs The First Validation That Intranasally Administered Foralumab is Well-tolerated and the Treatment Provides Clinical Benefits Foralumab treatment + Patient reported
Slide 10: Non-active Secondary Progressive Multiple Sclerosis (na-SPMS)
Fully Human Anti-CD3 mAb Non-active Secondary Progressive Multiple Sclerosis (na-SPMS)
Slide 11: Secondary Progressive Multiple Sclerosis Represents an Attractive Market
Secondary Progressive Multiple Sclerosis Represents an Attractive Market Approximately 25% of Relapsing Patients are treated with disease- Remitting MS (RRMS) patients are modifying standard of care for RRMS estimated to progress to SPMS* before running out of options Secondary Progressive Multiple
Slide 12: SPMS Development Program History and Next Steps
SPMS Development Program History and Next Steps Gathering 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 COVID T
Slide 13: EA1-6 Update: Reduction in Microglia Activation
EA1-6 Update: 5 out of 6 Dosed Showing Reduction in Microglia Activation EA6 13
Slide 14: Clinical Update on Patient EA2
Clinical Update on Patient EA2 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 abl
Slide 15: Expanded Access Non-Active MS Program Expanded
Expanded Access (EA) Non-Active MS Program Expanded to 6 Total na-SPMS Patients with the Aim of Enrolling a Total of 10 Patient Progress EA3 THROUGH EA6 EA7 THROUGH EA10 (4 patients) (additional 4 patients) All patients enrolled and received 6-month dose 3-month PET scans completed (3 of 4 with lowe
Slide 16: Foralumab Next Steps in na-SPMS: Phase 2a Plan and Read-Out Timing
Foralumab Next Steps in na-SPMS: Phase 2a Plan and Read-Out Timing First investigator meeting to start Q3 2023 and first patient to be enrolled Q4 2023 Design Endpoints Placebo-controlled PET Scan Multi-center Expanded Disability Status Scale (EDSS) Dose-ranging Improvement in Timed 25-Foot Walk Tes
Slide 17: Phase 2a Study Design in SPMS: Double-Blind, Placebo-Controlled
Phase 2a Study Design in SPMS: Double-Blind, Placebo-Controlled Intranasal foralumab dosing (n=54); 18 patients per treatment arm Primary Baseline Endpoints at 3 Each Cycle=3 Weeks / 4 cycles x3=12 weeks Screening Months Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Week 10 Week 11
Slide 18: Alzheimer's, ALS, Long COVID and Other Potential CNS-related Indications
Other Potential CNS-related Indications (Alzheimer’s, ALS, Long COVID and Intracerebral Hemorrhage) Intranasal anti-CD3 provides a unique approach for treating progressive neurologic diseases by modulating microglial cells. The intranasal route of immunotherapy has minimal toxicity and induces regul
Slide 19: Second PNAS Publication Validates Intranasal Foralumab MoA
Second Publication in Proceedings of National Academy of Sciences now Validates Intranasal Foralumab MoA for Treatment of Alzheimer's Disease Alzheimer’s disease (AD) is a neurodegenerative disease characterized by amyloid plaques, neurofibrillary tangles, and microglial activation. Therapies target
Slide 20: Alzheimer's Disease Program is Advancing
Alzheimer’s Disease Program is Advancing and Equally Exciting Start Phase 2 program in 1H of 2024 Letter to Proceed received for IND to conduct a Phase 2 study of intranasal foralumab in Alzheimer’s disease patients Phase 2 trial to assess microglial activation after 3 months of treatment of mild-to
Slide 21: Intranasal Foralumab in Amyotrophic Lateral Sclerosis (ALS)
Intranasal Foralumab in Amyotrophic Lateral Sclerosis (ALS) ALS patients have limited therapeutic options and a high unmet need In September 2022, a Lawrence & Isabel Barnett Drug Development Program Grant was awarded to the Ann We have now seen the potential of Romney Center for Neurologic Diseases
Slide 22: Tiziana Life Sciences Ltd. Management
Tiziana Life Sciences Ltd. Management Seasoned leaders at multiple biotechnology and pharmaceutical companies Gabriele Cerrone, Founder, Executive Chairman and Acting Matthew W. Davis, M.D., Chief Medical Officer and Chief Chief Executive Officer has founded ten biotechnology companies in Operating
Slide 23: In Summary…
In Summary… An exciting and innovative platform focused in areas of high unmet need, with significant momentum ahead Novel, fully human anti-CD3 intranasal mAb for potential treatment of multiple inflammatory diseases Mechanism of action validated in prestigious Proceedings of National Academy of Sc
Slide 24: US and UK Headquarters
US Headquarters (Pennsylvania) Tiziana Life Science Ltd. 601 New Britain Road Building 100, Suite 102 Doylestown PA 18901 UK Headquarters (London) Tiziana Life Sciences plc 14-15 Conduit Street London W1D 2XJ Investors: +44 7769 88 4020 info@tizianalifesciences.com
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