Tiziana Life Sciences Ltd · NASDAQ:TLSA
Tiziana Life Sciences — Investor Presentation (October 2022)
28 slides from Tiziana Life Sciences's investor presentation, Oct 25, 2022
Slide 1: Enabling Breakthrough Immunomodulation Approaches to Enhance the Functionality of Treg-Based Therapies
Enabling Breakthrough Immunomodulation Approaches to Enhance the Functionality of Treg - Based Therapies NASDAQ: TLSAx
Slide 2: Disclaimer and Forward-Looking Statement
Tiziana Life Sciences Overview | June 2022 2 Disclaimer and Forward - Looking Statement The content of this presentation has been prepared for the purpose of providing general information about, and an overview o f, the Company and its business. It is not intended to be a complete review of all matt
Slide 3: Investment Highlights
Tiziana Life Sciences Overview | June 2022 3 Investment Highlights Source: 1 Lu et al. Journal of Biomedical Science (2020) 27:1 Innovative, clinically - validated, drug delivery platform based on immunomodulating approaches Recent clinical data support the MOA Global IP protection of antibody formu
Slide 4: Antibody Administration: Switching From IV and SC To Oral, Nasal And Inhaled Routes
Tiziana Life Sciences Overview | June 2022 4 Antibody Administration: Switching From IV and SC To Oral, Nasal And Inhaled Routes for Immunomodulating Therapies A Revolutionary Platform Benefits of non - systemic dosing • Improved patient compliance • Local activity instead of systemic distribution;
Slide 5: Positive Data From Five Clinical Studies Completed: Our Pipeline
Tiziana Life Sciences Overview | June 2022 5 Positive Data From Five Clinical Studies Completed Our P i p eline Subject PC IND Phase 1/IAP Phase 2 Phase 3 FORALUMAB Fully human anti - CD3 mAb Intranasal Oral Subcutaneous ANTI IL - 6 RECEPTOR Fully human mAb Inhalation Oral Progressive Multiple Scler
Slide 6: Lead Asset: Foralumab
Lead Asset: Foralumab The only fully human anti - CD3 monoclonal antibody in clinical studies Non - FC binding anti - CD3 antibody mutations expected to have improved safety profile
Slide 7: Foralumab is the Only Fully Human Anti-CD3 mAb in Clinical Trials
Tiziana Life Sciences Overview | June 2022 7 OKT3 Mu r omonab * IgG2a ChAglyCD 3 Otelixizumab IgG1 N297/A (Ala - Ala) hOKT3 γ1 Teplizumab IgG2 L234/A, L235A Nuvion Visilizumab IgG2 L234/A, V237/A Foralumab IgG1 L234/A, V335E Fully M urine Chimeri c & Humani z e d Humanized Humanized Fully Human Adap
Slide 8: Our Therapeutic Approach: Enhance Treg Production and Functionality
Tiziana Life Sciences Overview | June 2022 8 Our Therapeutic Approach Tregs Production and Enhance their Functionality Foralumab Facilitates Locally Targeted Immunomodulation to Improve Augment Tregs production Enhance Tregs Functionality Foralumab intranasal administration to facilitate local activ
Slide 9: Foralumab Mechanism of Action
Uptake Binding Signaling LAP induction IL - 10 TGF - b Tr1 CD8+ Treg Inhibition Effector T cell CD4 + FoxP3 + (Treg) CD4 + FoxP3 - FoxP3 induction Dendritic Cell Intranasal or Oral Foralumab Nasal or Gut Lumen gd T cell IL - 10 CD4 + LAP + (Th3) Anti - CD 3 mAb CD 3 /TCR complex Cytokines The bindin
Slide 10: First Validation That Intranasally Administered Foralumab is Well-Tolerated
Tiziana Life Sciences Overview | June 2022 10 The First Validation That Intran asally Administered Foralumab is Well - tolerated and the Treatment Provides Clinical Benefits Results: Biomarkers measured via cytokines and C - reactive proteins Cohort Lung CT Scan Cytokine IL - 6 C - Reactive Protein
Slide 11: Precision Biosciences Licensing Collaboration Validates Our Technology
Tiziana Life Sciences Overview | June 2022 11 Upfront payments • Multiple payments commensurate with meeting specified successful milestones • Royalties • Additional royalty options for subsequently developed CAR - T products • Precision to be responsible for the development, commercialization and c
Slide 12: Intranasal Foralumab for Treatment of Neurodegenerative Diseases (Multiple Sclerosis)
Tiziana Life Sciences Overview | June 2022 12 LifeSci Venture Partners Provides active guidance and differentiated support to enhance portfolio companies’ probability of success Intranasal F oralumab for Treatment of Neurodegenerative Diseases (Multiple Sclerosis) Intranasal Local action with improv
Slide 13: An Innovative Approach to Penetrate the Blood Brain Barrier Intranasally
Tiziana Life Sciences Overview | June 2022 13 An Innovative Approach to Penetrate the Blood Brain Barrier (BBB) Intranasally - Administered Foralumab for Neurodegenerative Diseases
Slide 14: Intranasally Administered Foralumab in SPMS Patient: 6-Month Treatment Data
Tiziana Life Sciences Overview | June 2022 14 Intranasally Administered Foralumab in SPMS Patient: 6 - Month Treatment Data * These biomarkers are known to be associated with multiple sclerosis pathogenesis and progression Two patients were dosed with intranasal foralumab M - W - F for two weeks wit
Slide 15: Assessment of Inhibition of Microglial Activation by PET Imaging
Tiziana Life Sciences Overview | June 2022 15 Assessment of Inhibition of Microglial Activation by PET Imaging Following Treatment with Nasally Administered Foralumab in First SPMS Patient
Slide 16: Graph Depicting Microglial Activation PET Signal in Different Brain Regions
Tiziana Life Sciences Overview | June 2022 16 Graph Depicting Microglial Activation PET Signal in Different Regions of the Brain at Various Time Points
Slide 17: Intranasally Administered Foralumab in SPMS Patient: Second Patient Data
Tiziana Life Sciences Overview | June 2022 17 Intranasally Administered Foralumab in SPMS Patient: 6 - Month Treatment Data *Percent reduction is based on changes from baseline in SUVR - 1, a surrogate index for PET binding potential. SUVR=Standardized U ptake Value Ratio, calculated with reference
Slide 18: Other Potential CNS-related Indications (Alzheimer's and ALS)
Tiziana Life Sciences Overview | June 2022 18 LifeSci Venture Partners Provides active guidance and differentiated support to enhance portfolio companies’ probability of success Other Potential CNS - related Indications (Alzheimer’s and ALS) Intranasal anti - CD3 provides a unique approach for treat
Slide 19: Proof-of-Concept Demonstrated in Alzheimer's Disease
Tiziana Life Sciences Overview | June 2022 19 Study Presented at the Alzheimer’s Association International Conference® (AAIC®) Proof - of - Concept Demonstrated in Alzheimer’s Disease In this study animal models of Alzheimer’s disease (AD) demonstrated that microglia activity was restored and cognit
Slide 20: IND for Intranasal Foralumab in Alzheimer's Planned Submission Q2/Q3 2023
Tiziana Life Sciences Overview | June 2022 20 IND for Intranasal Foralumab in Alzheimer’s Planned Submission Q2/Q3 2023 Receive an affirmative written response from the FDA on a Pre - Investigational New Drug Application (PIND) Submit an Investigational New Drug Application (IND) to conduct a Phase
Slide 21: Intranasal Foralumab in Amyotrophic Lateral Sclerosis (ALS)
Tiziana Life Sciences Overview | June 2022 21 Intranasal Foralumab in Amyotrophic Lateral Sclerosis (ALS) • In September, a Lawrence & Isabel Barnett Drug Development Program Grant was awarded to the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital (BWH) by the ALS Associati
Slide 22: Oral Foralumab for Inflammatory Bowel Diseases (Crohn's Disease)
Tiziana Life Sciences Overview | June 2022 22 LifeSci Venture Partners Provides active guidance and differentiated support to enhance portfolio companies’ probability of success Oral Foralumab for Inflammatory Bowel Diseases (Crohn’s Disease) Oral capsules Foralumab , a fully human anti - CD3 mAb
Slide 23: Orally-Administered Foralumab in Phase 1a Trial in Healthy Volunteers
Tiziana Life Sciences Overview | June 2022 23 Orally - Administered Foralumab in Phase 1a Trial in Healthy Volunteers Clinical results Single ascending dose, double - blind, placebo - controlled study in healthy subjects Foralumab administered at 1.25, 2.5 and 5.0 mg/dose in enteric - coated capsule
Slide 24: Phase 1B Study Design in Crohn's Disease
Tiziana Life Sciences Overview | June 2022 24 Oral Foralumab Dosing (n=8) Phase 1B Study Design in Crohn’s Disease Primary Endpoints Safety Tolerability Clinical and immune signal responses 2 nd Review by Safety Monitoring Committee Dosing period 2.5mg daily One week break Follow up period Day 0 N=6
Slide 25: Validated Proof of Concept for Oral Administration of OKT3 in Ulcerative Colitis
Tiziana Life Sciences Overview | June 2022 25 * Boden, E. K., Canavan, J. B., Moran, C. J., McCann, K., Dunn, W. A., Farraye, F. A., Ananthakrishnan, A. N., Yajnik, V., Gandhi, R., Nguyen, D. D., Bhan, Aantibodies. K., Weiner, H. L., Korzenik, J. R., Snapper, S. B. Immunologic alterations associated
Slide 26: Oral Milciclib for NSCLC
Tiziana Life Sciences Overview | June 2022 26 LifeSci Venture Partners Provides active guidance and differentiated support to enhance portfolio companies’ probability of success Oral Milciclib for NSCLC Broad - spectrum inhibitory activities of milciclib on CDKs are favorable Milciclib CDK 5 CDK2 CD
Slide 27: Phase 2 Study of Milciclib + Gemcitabine in Refractory Solid Tumors
Tiziana Life Sciences Overview | June 2022 27 Phase 1 Study of Milciclib + Gemcitabine in Refractory Solid Tumors Trial Design 16 Patients with refractory solid tumors Treated with oral milciclib at three dose levels (45, 60, and 80 mg/m 2 /day) With a fixed dose of IV gemcitabine (1000 mg/m 2 /day)
Slide 28: Contact Us
US Headquarters (Pennsylvania) Tiziana Life Science Ltd. 601 New Britain Road Building 100, Suite 102 Doylestown PA 1890 1 UK Headquarters (London) Tiziana Life Sciences plc 55 Park Lane London W1K 1NA +44 7769 88 4020 hmalik@tizianalifesciences.com Contact Us
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