Tiziana Life Sciences Ltd · NASDAQ:TLSA
Tiziana Life Sciences — Investor Presentation (August 2020)
27 slides from Tiziana Life Sciences's investor presentation, August 2020
Slide 1: Corporate Presentation August 2020
An Innovative Platform in Oral, Nasal and Inhalation for Monoclonal Antibody Administration Proprietary inhalation delivery of anti-IL-6R mAb for COVID-19 treatment Advanced clinical programs in Crohn’s Disease, progressive Multiple Sclerosis, and Hepatocellular Carcinoma August 2020 Corporate Prese
Slide 2: Disclaimer and Forward Looking Statements
DISCLAIMER AND FORWARD LOOKING STATEMENTS 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
Slide 3: Key Members of Executive Team
KEY MEMBERS OF EXECUTIVE TEAM Kunwar Shailubhai PhD, Key Strengths of the MBA Gabriele Cerrone, MBA Executive Chairman Management Team CEO & CSO Executive Director • Successful track record in • Proven track record & experience in • Co-founder , EVP & CSO of Synergy financing biotechnology companies
Slide 4: Scientific Advisory Committee
SCIENTIFIC ADVISORY COMMITTEE Howard Weiner, MD Angelo Sangiovanni, MD Professor of Neurology at Harvard Med Adjunct Professor of Gastroenterology at the University of Milan Director and Founder of the Partners MS Center and Co-Director of the Ann Romney Center for Neurologic Diseases Leader
Slide 5: Investment Highlights
INVESTMENT HIGHLIGHTS Foralumab Oral Trial: FDA approved IND • Transformational platform technologies: Proprietary oral, nasal and inhaled formulation Phase 1 oral trial completed technologies to transform immunotherapies with Monoclonal Antibodies (‘mAbs’) currently Phase 2 oral in CD by Q3/Q4, 202
Slide 6: A Revolutionary Platform / The Large Market Opportunity
A REVOLUTIONARY PLATFORM THE LARGE MARKET OPPORTUNITY Market opportunity for SWITCH ANTIBODY ADMINSTRATION FROM INTRAVENOUS mAb therapeutics is TO ORAL, NASAL AND INHALED ROUTES greater than TODAY’S ANTIBODY ADMINISTRATION OPTIONS ARE MOSTLY I.V. $ 110 Antibodies (mAbs) reformulated for oral adminis
Slide 7: Development Pipeline
DEVELOPMENT PIPELINE PHASE 2 TO BEGIN Nasal Trial LEAD Pro-MS DISCOVERY PRE-CLINICAL IND PHASE 1 PHASE 2 PHASE 3 OPTIMIZATION Foralumab Intranasal formulation for Neurodegenerative disease PHASE 2 TO Nasal Administration Starting Phase 2 shortly BEGIN Oral trial in Enteric coated capsules Crohn’s Di
Slide 8: Oral, Nasal & Inhalation
ORAL ADMINISTRATION Successfully completed Phase 1 trial with orally administered Foralumab Phase 2 trial in Crohn’s Disease to start shortly P L A T F O R M T E C H O L O G I E S NASAL ADMINISTRATION Phase 1 trial completed for related neurodegenerative diseases such as Progressive Multiple Scleros
Slide 9: The Only Fully Human Anti-CD3 mAb in Clinical Trials
THE ONLY FULLY HUMAN ANTI-CD3 MAB IN CLINICAL TRIALS CD3-SPECIFIC MONOCLONAL ANTIBODIES IN CLINICAL DEVELOPMENT OKT3 CHAGLYCD3 NUVION HOKT3γ1(ALA- Oral and Nasal Administration MUROMONAB OTELIXIZUMAB VISILIZUMAB ALA) TEPLIZUMAB FORALUMAB Market Opportunities IgG2a IgG1 IgG2 IgG2 IgG1 *Agly *AA *AA *
Slide 10: Oral and Nasal Formulation Patents Pending
ORAL AND NASAL FORMULATION PATENTS PENDING Nasal administration of Foralumab Patent covers Foralumab and other mAbs Proof-of-concept demonstrated in ANTI-CD 3 ANTIBODY FORMULATIONS GRANTED Applicant(s): Tiziana Life Sciences PLC animal studies Inventor(s): SHAILUBHAI, Kunwar Phase 1 study for ne
Slide 11: Phase 1 Clinical Data with Nasally Administered Foralumab
PHASE 1 CLINICAL DATA WITH NASALLY ADMINISTERED FORALUMAB Phase 1 trial conducted at Brigham and Women’s Hospital completed July 2019 Dose-ranging, double-blind, placebo-controlled study in healthy subjects Foralumab was administered nasally at 10, 50 and 250 µg per day, consecutively for 5 da
Slide 12: Phase 1 Clinical Data with Orally Administered Foralumab
PHASE 1 CLINICAL DATA WITH ORALLY ADMINISTERED FORALUMAB Phase 1 trial conducted at Brigham and Women’s Hospital completed December 2019 Single ascending dose, double-blind, placebo-controlled study in healthy subjects Foralumab administered at 1.25, 2.5 and 5.0 mg/dose as stabilized powder fo
Slide 13: Oral Anti-CD3 Concept Validated in Ulcerative Colitis
THE CONCEPT FOR ORAL ADMINISTRATION WITH ANTI-CD3 MAB IS VALIDATED WITH CLINICAL DATA IN ULCERATIVE COLITIS Conducted by Dr. Scott Snapper at Harvard Medical School Determined the immunologic effects and safety of orally delivered anti-CD3 antibody in patients with moderate-to-severe ulcerative
Slide 14: Proof-of-Concept in NASH Patients
PROOF-OF-CONCEPT IN NASH PATIENTS ORAL TREATMENT WITH MURINE ANTI-CD3 (OKT3) EFFECTIVE IN A PHASE 2 TRIAL WITH NASH1 STUDY DESIGN SAFETY IMMUNOLOGICAL EFFICACY BIOMARKERS 36 subjects with NASH and Well tolerated by all Increases in Treg markers Positive trends, some of type II diabetes patie
Slide 15: Patent Application Filed for Anti-IL-6R mAbs for COVID-19
PATENT APPLICATION FILED FOR COMPOSITION AND METHOD OF USE OF ANTI-IL- 6R MONOCLONAL ANTIBODIES FOR TREATMENT OF COVID-19 Applicant: Tiziana Life Sciences PLC • Excessive levels of circulating IL6 is the major cause of COVID-19 progression. Thus depletion of circulating IL6 is an attractive approach
Slide 16: Therapeutic Options During Progression of COVID-19
THERAPEUTIC OPTIONS DURING PROGRESSION OF COVID-19 Antiviral Treatment Anti-inflammatory Treatment Hyperinflammation in lungs Death Viral Infection Progression of COVID-19 Viral Proliferation Cytokine Storm (IL-6 & TNF-α) Lung damage Time Course Our patent covers the inhalation delivery anti-IL-6R m
Slide 17: HCC Is a Complex and Heterogenous Cancer
HCC is a complex and heterogenous cancer associated with multiple etiological factors A PAN-CDK INHIBITOR FOR TREATMENT NASH OF HEPATOCELLULAR CARCINOMA AND SOLID TUMORS Newer treatment approach with broad-spectrum action is needed to address heterogeneity of HCC 17 17
Slide 18: Small Molecule Pan-CDK Inhibitor
SMALL MOLECULE PAN-CDK INHIBITOR • Complex heterogeneity in HCC due to multiple etiological agents; Need for broad-spectrum approach • Orally-bioavailable small molecule with potent anti-tumor activity in a wide range of animal models Inhibitor of kinases associated with cancer cell growth includi
Slide 19: Clinical Data from Milciclib
CLINICAL DATA FROM MILCICLIB PHASE 2A TRIAL IN SORAFENIB-RESISTANT HCC PATIENTS Trial design: Oral administration (100 mg/day, consecutive 4 days a week in a 4-week cycle). Total patients 30 to be enrolled. Duration 6 months Primary end point: safety Secondary end points: PFS, ORR & TTP Exploratory:
Slide 20: StemPrinter Genomic Signature Platform
P L A T F O R M T E C H O L O G I E S • Superior assay based on a stemness signature genes for early prediction of Best-in-class genomic signature for ER+/HER2- recurrence of breast cancer prognosis of early and late recurrence of ER+/HER2- breast cancer patients in early • Side-by-side comparison s
Slide 21: Two Posters Presented at ASCO
TWO POSTERS PRESENTED AT ASCO 1. Comparison of StemPrintER, a Novel Biology-based Genomic Predictor of Distant Recurrence in Breast Cancer, with Oncotype DX in the TransATAC cohort, shows that StemPrintER: • Significantly (p<0.0001) stratifies high vs. low risk groups when adjusted for clinical para
Slide 22: Intellectual Property Portfolio
INTELLECTUAL PROPERTY PORTFOLIO FAMILY SUBJECT PRIORITY STATUS EXPIRES JURISDICTION Australia, Canada, China, Hong Kong, Israel, Japan, Mexico, Norway, Singapore, South Africa, Ukraine, Armenia, Austria, Azerbaijan, Belgium, Belarus, Switzerland, Germany, Methods of Use (Autoimmune or Inflammatory d
Slide 23: Upcoming Catalysts: Growth Objectives
UPCOMING CATALYSTS GROWTH OBJECTIVES TARGET PRODUCT ACTION/OBJECTIVE DATE Foralumab Phase 2 trial with orally administered Foralumab in Crohn’s Q3/Q4, 2021 Disease patients anticipated completion - INITIATION OF THE STUDY (Q3, 2020) - INTERIM ANALYSIS OF CLINICAL DATA (Q1, 20121) Foralumab Phase 2 t
Slide 24: Capital Structure
CAPITAL STRUCTURE FINANCING OBJECTIVES TILS Ordinary TLSA ADS Shares • Issued share capital 190,559,823 95,279,912 • Warrants (WAEP: £1.23) 2,413,268 1,206,634 • Options (WAEP: £0.37) 18,279,403 9,139,702 _ _ _ 211,252,494 105,626,248 Fully Diluted Shares *Information prepared as of 5 August 2020. 1
Slide 25: Contact Us
CONTACT US US Headquarters Tiziana Therapeutics Inc Pennsylvania Biotechnology Center of Bucks County 3805 Old Easton RD Doylestown, PA 18902-8400 An Innovative Platform in Oral, Nasal and Inhalation for Monoclonal Antibody Administration UK Headquarters Tiziana Life Sciences plc Differentiated Trea
Slide 26: Clinical Data Suggest Milciclib Overcomes Gemcitabine Resistance
CLINICAL DATA SUGGEST MILCICLIB OVERCOMES GEMCITABINE RESISTANCE PATIENTS RAPIDLY ACQUIRE RESISTANCE TOWARDS CHEMOTHERAPIES Phase 1 Dose-Escalation Study of Milciclib in Combination with Gemcitabine in Patients with KEY FINDINGS FROM PHASE 1 STUDY Refractory Solid Tumors* 1. Milciclib well-tolerated
Slide 27: How Does Our Platform Technology Work?
HOW DOES OUR PLATFORM TECHNOLOGY WORK? NOVEL APPROACH FOR SITE-TARGETED IMMUNOMODULATION Gut Lumen PANETH CELL M CELL INTESTINAL EPITHELIAL CELLS Intraepithelial Lamina Propria Lymphoid lymphocytes follicle Dendritic cells Mesenteric lymph node Treg cell NKT cells induction Macrophages Site-targeted
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