Tiziana Life Sciences Ltd · NASDAQ:TLSA
Tiziana Life Sciences — Investor Presentation (August 2024)
24 slides from Tiziana Life Sciences's investor presentation, August 2024
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: 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. market for Intranasal foralumab Phase MS Clinical data and Experienced scientific neuroinflammatory and 2 study in non-active publication in PNAS1 advisory board and neurodegenerative Secondary Progressive management team that have anti-CD3 antibody treatment
Slide 4: Lead Asset: Intranasal Foralumab
Lead Asset: Intranasal Foralumab The only fully human anti-CD3 monoclonal antibody in clinical studies
Slide 5: 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 6: Foralumab: Intranasal 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 Creation and activation of Tregs 2 Binding CD3/TCR complex BBB Blood-Brain-Barrier Tregs will cross the blood Uptake T cell 3 brain barri
Slide 7: 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 8: Non-active Secondary Progressive Multiple Sclerosis (na-SPMS)
Non-active Secondary Progressive Multiple Sclerosis (na-SPMS)
Slide 9: 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 10: SPMS Development Program History and Next Steps
SPMS 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 COVID Trial Thir
Slide 11: EA1-6 Update: Reduction in Microglia Activation
EA1-6 Update: 5 Out of 6 Dosed Showing Reduction in Microglia Activation EA6 11
Slide 12: 6 Month Clinical Update Demonstrates Improvements or Stabilization in all Patients
6 Month Clinical Update Demonstrates Improvements or Stabilization in all Patients 70% of patients demonstrated improved fatigue scores EA6 EDSS Pyramidal score T25FW MFIS EA1 ↓ EA2 ↓ ↓ ↓ EA3 ↓ EA4 ↓ ↓ EA5 ↓ ↓ ↓ EA6 ↓ EA7 ↓ ↓ EA8 ↓ ↓ ↓ EA9 ↓ ↓ EA10 ↓ Denotes stabilization ↓ Denotes improvement 12
Slide 13: 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 14: Expanded Access Non-Active MS Program Summary
Expanded Access (EA) Non-Active MS Program Summary Patient Progress First Ten Patients • All patients received at least 6-months of treatment • Clinical improvements or stabilization was reported across the entire group • Median reduction of 36% in White Matter Z-scores • Fatigue scores as measured
Slide 15: Microglial Activation Dampened as Measured by White Matter Z-scores
Microglial Activation Dampened as Measured by White Matter Z-scores Data from Expanded Access program: Quantitative [F18]PBR06-PET data showed the dampening of microglial activation, an indicator of brain inflammation. Reductions of 28% to 48% were seen, indicating improvement in 5 out of 6 patients
Slide 16: Foralumab na-SPMS: Phase 2a Program Ongoing
Foralumab na-SPMS: Phase 2a Program Ongoing Design Endpoints Placebo-controlled PET Scan Multi-center Expanded Disability Status Scale (EDSS) Dose-ranging Multiple Sclerosis Functional Composite Established outcome measures 16
Slide 17: Phase 2a Study Design in na-SPMS: Double-Blind, Placebo-Controlled
Phase 2a Study Design in na-SPMS: Double-Blind, Placebo-Controlled Intranasal foralumab dosing (n=54); 18 patients per treatment arm Primary Endpoint Baseline at 3 Months of Each Cycle=3 Weeks / 4 cycles x3=12 weeks Screening Treatment Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 W
Slide 18: Alzheimer's Disease
Alzheimer’s Disease Amyloid-Related Imaging Abnormalities (ARIA) 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 regulatory T cells locally, that then mi
Slide 19: Second Publication in PNAS: Intranasal Foralumab for Alzheimer's Disease
Second Publication in Proceedings of National Academy of Sciences Intranasal Foralumab as a Potential for Treatment of Alzheimer's Disease Alzheimer’s disease (AD) is a neurodegenerative disease characterized by amyloid plaques, neurofibrillary tangles, and microglial activation. Therapies targeting
Slide 20: Alzheimer's Disease Program is Advancing and Equally Exciting
Alzheimer’s Disease Program is Advancing and Equally Exciting Phase 2 Alzheimer’s Disease IND cleared for trial to start in 2024 Letter to Proceed received for Phase 2 trial planned to start IND to conduct a Phase 2 study 2024 and will assess microglial of intranasal foralumab in activation as part
Slide 21: Preclinical Studies Suggest Possible Benefit in Preventing and Treating ARIA
Preclinical Studies Suggest Possible Benefit in Preventing and Treating Amyloid-Related Imaging Abnormalities (ARIA) Nasal anti-CD3 represents a novel therapeutic approach for treating ICH and potentially other types of acute brain injury https://www.linkedin.com/posts/saef-izzy-a8a484a5_aan2023-neu
Slide 22: 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 neuroinflammatory and neurodegenerative diseases Mechanism of action published in prestigious Proceeding
Slide 23: Tiziana Life Sciences Ltd. Management
Tiziana Life Sciences Ltd. Management Seasoned leaders at multiple biotechnology and pharmaceutical companies Ivor Elrifi, Chief Executive Officer was formerly the global head of the William Clementi, Pharm. D., FCP, Chief Development Keeren Shah, Chief Financial Officer Ms. Patent Group at Cooley s
Slide 24: US Headquarters (New York) and UK Headquarters (London)
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 7769 88 4020 info@tizianalifesciences.com
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