Tiziana Life Sciences Ltd · NASDAQ:TLSA

Tiziana Life Sciences — IPO Roadshow (September 2018)

36 slides from Tiziana Life Sciences's IPO roadshow presentation, Sep 25, 2018

  1. Slide 1: Issuer Free Writing Prospectus

    Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Dated September 24 , 2018 Registration Statement No . 333 - 226368 Relating To Preliminary Prospectus dated September 24 , 2018 Free Writing Prospectus Tiziana Life Sciences plc – Investor Presentation This free writing prospectus relates to

  2. Slide 2: Tiziana Life Sciences Investor Presentation

    LSE:TILS Proprietary & Confidential © 2018 Tiziana Life Sciences plc LSE: TILS Kunwar Shailubhai, PhD, MBA | CEO & CSO | September 2018 Targeted Therapeutics for: • NASH & Liver Diseases • Hepatocellular Carcinoma • Thymic Carcinoma & Thymoma

  3. Slide 3: Disclaimer & Notice of Forward Looking Statements

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc 3 DISCLAIMER & NOTICE OF FORWARD LOOKING STATEMENTS This institutional presentation document has been prepared by Tiziana Life Sciences plc ("Tiziana”) for information purposes only in relation to the proposed placing of American Depositary

  4. Slide 4: Disclaimer & Notice of Forward Looking Statements

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc 4 DISCLAIMER & NOTICE OF FORWARD LOOKING STATEMENTS This presentation is directed at and is only being distributed (A) in member states of the European Economic Area ("EEA"), to persons who are "qualified investors" as defined under the Pro

  5. Slide 5: Background Story of the Company

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc 5 BACKGROUND STORY OF THE COMPANY • Founded in 2013 as a London Stock Exchange AIM - listed biotechnology company (LSE: TILS) • Focus on therapeutics and diagnostics for cancer and immune diseases • December 2014 : Licensed Foralumab, a ful

  6. Slide 6: Do It Again with Proven Business Strategy

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc 6 DO IT AGAIN WITH PROVEN BUSINESS STRATEGY □ Management Strategy 1. Focused primarily on liver diseases 2. Strong pipeline with range of candidates 3. Supported by world renowned academics through advisory board □ Proprietary technologies

  7. Slide 7: Leadership Team & Board of Directors

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc 7 LEADERSHIP TEAM & BOARD OF DIRECTORS MANAGEMENT BOARD Gabriele Cerrone Executive Chairman • Career as a executive in the banking and corporate finance sector and director of publicly listed companies • Kredietbank N.V., Citibank, Generale

  8. Slide 8: Scientific Advisory Board

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc 8 SCIENTIFIC ADVISORY BOARD SCIENCE ADVISORY Napoleone Ferrara MD • Inventor of Avastin® ($6.67Bn/ yr )*; 2010 Lasker Award • Senior Deputy Director Basic Sciences, Moores Cancer Center, UC San Diego • Distinguished Prof of Pathology, Schoo

  9. Slide 9: Focused on Liver Diseases

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc 9 FOCUSED ON LIVER DISEASES 25 - 30% of US Population Healthy Liver Non - Alcoholic Fatty Liver Disease NAFLD Generally asymptomatic Reversible Non - alcoholic Steatohepatitis NASH Cirrhosis 3 - 5% of popn 20% over 10 years ~20% of global p

  10. Slide 10: Major Achievements & Anticipated Near Term Milestones

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc 10 Foralumab (TZLS - 401) • Complete enteric coated capsule formulation and manufacture cGMP clinical supply 4Q 2018 • Submit IND for oral administration with Foralumab capsules 4Q 2018 • Initiate Phase 1 dosing in healthy volunteers with e

  11. Slide 11: Clinical Development Pipeline

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc 11 CLINICAL DEVELOPMENT PIPELINE Phase Iia trial ongoing Discovery Lead Optimisation Pre - Clinical IND Phase 1 Phase 2 Phase 3 NDA Foralumab TZLS - 401 Anti - CD3 mAb Milciclib TZLS - 201 CDK Inhibitor Phase I Intranasal formulation for Ne

  12. Slide 12: Clinical Development Pipeline: Foralumab

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc CLINICAL DEVELOPMENT PIPELINE Foralumab: A fully human anti - CD3 mAb licensed from Novimmune • Phase 1 trials in NASH and Crohn’s Disease with an enteric coated capsule formulation for oral administration • Phase 1 trial in neurodegenerati

  13. Slide 13: Blockbuster antibody drugs and Foralumab opportunity

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc 13 • #1 : Humira (Adalimumab): Humira topped the global prescription - drug list and had annual revenue growth of 14.6% to reach global revenue of USD 18.43 billion. • #4 : Rituxan (Rituximab, MabThera ) : Rituxan held 4 th position in the

  14. Slide 14: Novimmune Partnerships and In-licensed mAbs

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc 14 DECEMBER 2017 • Championed the monoclonal and bispecific antibody generation platforms designed to streamline the identification, production and characterization of fully - human antibodies • Novimmune partnered with Genentech to develop

  15. Slide 15: Foralumab: The Only Fully Human Anti-CD3 mAb

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc 15 F ORALU M A B – THE ONLY FULLY HUM A N ANTI - CD3 MAB CD3 - specific monoclonal antibodies in clinical development 1 T cell Modulation NASH T1D GVHD IBD MS Lupus Psoriasis RA OK T 3 M u r o m o n ab I g G2 a F u ll y M o u s e N I - 0 40

  16. Slide 16: Howard Weiner - Key Opinion Leader

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc 16 HOWARD WEINER - TOP TIER KEY OPINION LEADER IN MS AND AUTOIMMUNE DISEASES • Director of Multiple Sclerosis Program, Department of Neurology, Brigham and Women’s Hospital ( BWH ). • Robert L Kroc Professor of Neurology, Harvard Medical Sc

  17. Slide 17: Oral Murine Anti-CD3 Effective in Phase II NASH Trial

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc 17 ORAL TREATMENT WITH MURINE ANTI - CD3 (OKT3) EFFECTIVE IN A PHASE II TRIAL WITH NASH 1 Safety • No treatment - related adverse events • Well tolerated • No change in CD3+ lymphocyte count • Normal blood chemistry and blood cell counts Im

  18. Slide 18: Key Publication of Pre-Clinical Efficacy

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc 18 • Foralumab is as potent as OKT3 • Oral treatment with Foralumab is effective in animal studies • Mechanism of action is via activation of T regs that systemically circulate to elicit targeted immunomodulation Oral Treatment with Foralum

  19. Slide 19: How Does Orally Administered Foralumab Work?

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc 19 HOW DOES ORALLY ADMINISTERED FORALUMAB WORK? Paneth cell Dendritic cells M cell Intestinal epithelial cells Lymphoid follicle Mesenteric lymph node T reg cell induction Site - targeted Immunomodulation Lamina Propria Foralumab Gut lumen

  20. Slide 20: Patent on Oral Administration Antibody Formulations

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc 20 Patent on Oral administration ANTI - CD 3 ANTIBODY FORMULATIONS US Non - Provisional Patent Application No.: 62 / 380,652 , filed August 29 , 2017 PCT Application PCT/US 2017 / 049211 , filed, Aug 29 , 2017 Claims • Composition of matter

  21. Slide 21: Clinical Development Pipeline: Milciclib

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc CLINICAL DEVELOPMENT PIPELINE Milciclib: A pan - inhibitor of CDKs, TRKs and Src kinase • Phase IIa trial in HCC with Milciclib (Italy, Greece & Israel) • Phase IIb trial with combination of Milciclib and Sorafenib (Italy, Greece, Spain and

  22. Slide 22: Milciclib, a Small Molecular Pan-Inhibitor of CDKs

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc 22 MILCICLIB, A SMALL MOLECULAR PAN - INHIBITOR OF CDKS • A novel small molecule with potent anti - tumor activity in a wide range of animal models with remarkably low toxicity • Inhibitor of a wide range of kinases associated with cancer c

  23. Slide 23: Milciclib Inhibits miR221/222 to Suppress HCC Tumor Growth in Mice

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc 23 Impressive milciclib effect, with clear reduction in the number and volume of lesions observed after treatment MR images, control vs. milciclib treated mice, pre - /post - treatment 30 mg/kg/day 10 days treatment % tumor growth, pre - /p

  24. Slide 24: Milciclib and Sorafenib May Have Synergistic Effect

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc 24 MILCICLIB AND SORAFENIB MAY HAVE SYNERGISTIC EFFECT Synergistic effect on HCC with sorafenib expected Chronic Inflammation / dysregulation of cell cycle Cell cycle regulators Normal Liver MTK PI - 3K Akt VEGF PDGF miRNA 122 miRNA 221 miR

  25. Slide 25: Key Findings

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc 25 Key Findings • Milciclib was well - tolerated with manageable side effects in patients with refractory solid tumors • Oral treatment with milciclib in combination with gemcitabine demonstrated clinical activity in patients who were non -

  26. Slide 26: Milciclib Met Primary Endpoint in Two Phase II Trials

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc 26 Tiziana Life Sciences Announces that Milciclib Met its Primary Endpoint in Two Phase II Clinical Trials in Patients with Thymic Carcinoma and Thymoma November 23, 2017 With long - term safety and efficacy profile, Milciclib could potenti

  27. Slide 27: Thymic Carcinoma and Thymoma Updates

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc 27 THYMIC CARCINOMA AND THYMOMA UPDATES • Two phase II trials with Milciclib in US, Italy and France - Trial 006: Thymic carcinoma and Thymoma mixed population (72 patients) - Trial 007: Thymic carcinoma and Thymoma mixed population (30 pat

  28. Slide 28: Two Phase Trials Demonstrated Clinical Activity and Safety of Milciclib

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc 28 TWO PHASE 2 TRIALS DEMONSTRATED CLINICAL ACTIVITY AND SAFETY OF MILCICLIB IN THYMIC CARCINOMA AND THYMOMA PATIENTS ~50% of patients had PFS at 7 months and 30% had PFS at 12 months ~50% of patients had OS at 24 months and 30% had OS at 3

  29. Slide 29: Long Term Safety of Milciclib

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc 29 LONG TERM SAFETY OF MILCICLIB • Five patients from the - 006 study and two patients from the - 007 study have continued on the Milciclib regimen with good clinical response and safety • Some patients have been taking Milciclib since 2012

  30. Slide 30: Interim Analysis Data from Milciclib Trial in Sorafenib-Resistant HCC

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc 30 INTERIM ANALYSIS DATA FROM MILCICLIB PHASE 2 TRIAL IN SORAFENIB - RESISTANT HCC PATIENTS • Why interim analysis: Since this was the first exposure of Milciclib in HCC patients with, it was important to ensure safety of patient with under

  31. Slide 31: Milciclib Clinical Program

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc 31 MILCICLIB CLINICAL PROGRAM Encouraging clinical data warrant further evaluation in HCC Current focus Completed trials Indication Phase Dose N Outcome Advanced metastasis Solid tumors 1 45 - 80 mg/m 2 / day + gemcitabine at 1000mg/m 2 16

  32. Slide 32: Preclinical Pipeline

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc PRECLINICAL PIPELINE TZLS - 501, a fully human anti - IL6 receptor mAb , a preclinical candidate Not budgeted. • Multiple Myeloma • Rheumatoid Arthritis

  33. Slide 33: Fully Human Anti-IL-6R Monoclonal Antibody

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc 33 DECEMBER 2017 TZLS - 501 Fully human anti - interleukin - 6 receptor (IL - 6R) monoclonal antibody ( mAb ) Mechanism Indications Opportunity Competitive Edge IP/Ownership • Interleukin - 6 (IL - 6) is a potent cytokine regulating cell gr

  34. Slide 34: IP Portfolio

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc IP PORTFOLIO

  35. Slide 35: Intellectual Property Portfolio

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc 35 INTELLECTUAL PROPERTY PORTFOLIO Family Subject Priority StatusExpires Jurisdiction Issued/ Pending Methods of Use (In combination with anti-IL- 6/IL-6R antibodies) 2011 Pending 2032 US Formulations and dosing regimen 2016 Pending 2037 US

  36. Slide 36: Near Term Milestones and Use of Proceeds

    Proprietary & Confidential © 2017 Tiziana Life Sciences plc 36 NEAR TERM MILESTONES AND USE OF PROCEEDS The anticipated proceeds of the proposed offering will be used to accomplish the following in 2019 • Foralumab (TZLS - 401) – Complete two, Phase 1 trials with oral and nasal administration of for

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