Tiziana Life Sciences Ltd · NASDAQ:TLSA
Tiziana Life Sciences — IPO Roadshow (August 2019)
30 slides from Tiziana Life Sciences's IPO roadshow presentation, Aug 6, 2019
Slide 1: An Innovative Platform in Oral and Nasal Antibody Administration
An Innovative Platform in Oral and Nasal Antibody Administration A Novel Approach for Treatment of Hepatocellular Carcinoma T L S A : T I L S : INVESTOR PRESENTATION A u g u s t 2 0 1 9
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: Free Writing Prospectus
FREE WRITING PROSPECTUS We have filed a registration statement (including a preliminary prospectus) with the SEC for the offering to which this presentation relates . The registration statement has not yet become effective . Before you invest, you should read the preliminary prospectus in the regist
Slide 4: Offering Summary
I SS U E R : T I ZI A NA L I FE SCI EN CE S, PL C Approximate Offering Size $10.0 Million of ADSs Listings/Symbols Nasdaq Global Market / TLSA and AIM / TLS Over - Allotment Option 1 5 % Use of Proceeds Advance the clinical development of Foralumab and Milciclib, and other research and development p
Slide 5: Investment Highlights
Innovative platform technology for oral and nasal formulations can transform the administration of Monoclonal Antibodies (‘mAbs’) Two de - risked assets in clinical evaluation that target the root causes of autoimmune/inflammatory diseases and cancer Milciclib has received ‘Orphan Drug Designation’
Slide 6: Leadership and Executive Team
□ Inventor of Oral Formulation of Foralumab □ Co - founder , EVP & CSO of Synergy Pharmaceuticals, NASDAQ: SGYP □ The pioneer of GC - C agonist technology inventor of TRULANCE approved for Chronic constipation and IBS - C □ VP, Callisto Pharmaceuticals LEADERSHIP AND EXECUTIVE TEAM Kunwar Shailubhai
Slide 7: Board of Directors and Scientific Advisory
Gabriele Cerrone Executive Chairman □ Proven track record & experience in financing biotechnology companies □ Founder and chairman of two biotech companies with market cap over $2 B □ Inhibitex sale $2.5 B □ Synergy / Trovagene / Gensignia / Rasna / Contravir / Siga Technologies □ MBA, Stern School
Slide 8: Platform Enables Oral and Nasal Antibody Administration
platform enables… □ Costly Infusion Center □ Poor patient compliance □ Higher toxicity □ Systemic treatment to affect whole body □ Infusion related side effects TODAY’S ANTIBODY ADMINISTRATION OPTIONS ARE MOSTLY I.V. Antibodies (mAbs) reformulated for oral administration Antibodies (mAbs) reformulat
Slide 9: The Multi Billion Dollar Market for Liver Diseases and Crohn's Disease
HEALTHY LIVER NON - ALCOHOLIC FATTY LIVER DISEASE NALFD 25 - 30% of Population C I RRH O S I S H E PATOCELLULAR CANCER amage Immune cells infiltration Foralumab (Anti - CD3) for NASH and Crohn’s Disease □ NASH global market ~ $35 B/year □ Crohn’s Disease market: $10B /year by 2025 □ Oral/nasal treat
Slide 10: Development Pipeline
DISCOVERY L E A D OPTIMIZATION PRE - CLINICAL I N D PHASE 1 PHASE 2 PHASE 3 DEVELOPMENT PIPELINE Intranasal formulation for Neurodegenerative disease Nasal Administration Enteric coated capsules for NASH Oral Administration Enteric coated capsules for Crohn’s disease Oral Administration Crohn’s dise
Slide 11: Platform Technologies
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 Sclerosis (Pro - MS): Top line data expected August 2019 ORAL ADMINISTRATION Phase 1 trial with enteric coated capsule formulation for oral administr
Slide 12: The Only Fully Human Anti-CD3 mAb
OKT3 M U R O M O N A B CHAGLYCD3 O T E L I X I Z U M A B NUVION V I S I L I Z U M A B HOKT3 1(ALA - ALA) TEPLIZUMAB NI - 0401 F O R A L U M A B I g G 2 a IgG1 * A g l y I g G 2 *AA I g G 2 *AA Chimeric & H u m an i z ed H u m an i z ed H u m an i z ed IgG1 *AE Fully Human Fully Mouse Approved by the
Slide 13: How Does Our Platform Technology Work?
HOW DOES OUR PLATFORM TECHNOLOGY WORK? NOVEL APPROACH FOR SITE-TARGETED IMMUNOMODULATION Ww, N v = Gut Lumen PANETH CELL M CELL ee a Coe INTESTINAL EPITHELIAL ©) CELLS ei We van emit 1 iti H Mesenteric ' Dendritic cells lymph node ! y's. . ' ™~S&’ Treg cell H NKT cells Nice r ' induction Macrophages
Slide 14: Oral and Nasal Formulation Patents Pending
a g Patent covers nd other mAbs ANTI - CD 3 ANTIBODY FORMULATIONS Applicant(s): Tiziana Life Sciences PLC Inventor(s): SHAILUBHAI, Kunwar US Non - Provisional Patent Application No.:62/380,652, filed August 29, 2016 PCT Application PCT/US2017/049211, filed, Aug 29, 2017 Patent estate □ In - licensed
Slide 15: Oral Anti-CD3 in Ulcerative Colitis Key Findings
□ Determined the immunologic effects and safety of orally delivered anti - CD 3 antibody in patients with moderate - to - severe ulcerative colitis (UC) □ Six subjects received oral OKT 3 * Boden, E. K., Canavan, J. B., Moran, C. J., McCann, K., Dunn, W. A., Farraye, F. A., Ananthakrishnan, A. N., Y
Slide 16: Foralumab Phase 2a Study in NASH
OKT3, a murine mAb, was withdrawn from the market due to severe side effect s Foralumab is a fully human anti - CD3 mAb with minimal side effects STUDY DESIGN S A FE T Y I MM U N O L O G I C A L EFFICACY BIOMARKERS □ 36 subjects with NASH and type II diabetes □ Randomized, single - blinded, placebo
Slide 17: Foralumab Is Functionally Equivalent to OKT3
KEY FINDINGS 1. Foralumab is as potent as OKT3 2. Treatment is effective in humanized mice studies 3. Mechanism of action is via activation of Tregs that systemically circulate to elicit targeted immunomodulation FORALUMAB IS FUNCTIONALLY EQUIVALENT TO OKT3 Oral Treatment prevents skin xenograft rej
Slide 18: Potential to Treat Type I Diabetes
KEY FINDINGS 1. Teplizumab (humanized OKT3), administered intravenously, significantly slowed progression to clinical Type 1 diabetes, with a median delay in the diagnosis of diabetes of 2 years 2. At the end of the trial, 57% of subjects treated with Teplizumab showed slowed progression to developm
Slide 19: Progress and Recent Events: NEJM Article
PROGRESS AND RECENT EVENTS 1 July 2019 Independent Third - Party Article in NewEngland JournalofMedicine reports on Intravenous Treatment with a Humanized Anti - CD3 mAb showing delays in progression of Type 1 Diabetes A recently published study in The New England Journal of Medicine titled,“An Anti
Slide 20: Progress and Recent Events: Milciclib Phase 2a Data
PROGRESS AND RECENT EVENTS 22 July 2019 Tiziana Reports Phase 2a Clinical Data with Milciclib Monotherapy in Sorafenib - refractory or - intolerant patients with unresectable or metastatic Hepatocellular Carcinoma 20 □ Milciclib was well tolerated and no drug related deaths were reported □ 28 out of
Slide 21: A Pan-CDK Inhibitor for Hepatocellular Carcinoma and Solid Tumors
A PAN - CDK INHIBITOR FOR TREATMENT OF HEPATOCELLULAR CARCINOMA AND SOLID TUMORS Source: Petrick et.al. J. Clin. Onc 34 (15) (2016) pg 1787 - 1795 Incidence of HCC is steadily increasing in males and females and subpopulations in US 21
Slide 22: Small Molecule Pan-CDK Inhibitor
SMALL MOLECULE PAN - CDK INHIBITOR □ Orally - bioavailable small molecule with potent anti - tumor activity in a wide range of animal models □ Inhibitor of kinases associated with cancer cell growth including CDK1, CDK2, CDK4 CDK5, CDK7 and src - family kinases □ Inhibits signaling pathways for hepa
Slide 23: Clinical Data from Milciclib Phase 2a Trial in HCC
Trial design: Oral administration (100 mg/day). Total patients 30 to be enrolled. Duration 6 months Primary end point: safety Secondary end points: PFS, ORR & TTP Exploratory: AFP and miRNA profiling Compassionate use: Upon request of patients with EC approval Trial complete: Data from 28 out of 31
Slide 24: Thymic Carcinoma and Thymoma Updates
THYMIC CARCINOMA AND THYMOMA UPDATES □ Two Phase 2 trials with Milciclib in US, Italy and France o Trial 006: Thymic carcinoma and Thymoma mixed population (72 patients) o Trial 007: Thymic carcinoma and Thymoma mixed population (30 patients ) □ Rare cancers with very few cases: Orphan Disease Indic
Slide 25: Milciclib Overcomes Drug Resistance
MILCICLIB OVERCOMES DRUG RESISTANCE KEY FINDINGS 1. Milciclib well - tolerated with manageable side effects with refractory solid tumors 2. Oral treatment in combination with gemcitabine demonstrated clinical activity in patients who were non - responder to existing chemotherapeutic drugs 3. Recomme
Slide 26: TZLS-501 Fully Human Anti-IL-6R mAb
TZ L S - 5 0 1 Fully human anti - interleukin - 6 receptor (IL - 6R) monoclonal antibody (mAb) to treat inflammatory disease GROWTH OPPORTUNUITY PRECLINICAL PIPELINE A FULLY HUMAN ANTI IL - 6 RECEPTOR MAB MECHANISM INDICATIONS OPPORTUNITY COMPETITIVE EDGE IP/OWNERSHIP □ Interleukin - 6 (IL - 6) is a
Slide 27: Intellectual Property Portfolio
INTELLECTUAL PROPERTY PORTFOLIO T Z L S - 4 0 1 T T Z L S - 2 0 1 FAMILY SUBJECT PRIORITY STATUS EXPIRES JURISDICTION Methods of Use (Autoimmune or Inflammatory diseases and disorders) 2004 Issued 2025 Australia, Canada, China, Hong Kong, Israel, Japan, Mexico, Norway, Singapore, South Africa, Ukrai
Slide 28: Catalysts
C A T A L Y S T S GROWTH OBJECTIVES PRODUCT ACTION/OBJECTIVE DATE Report Phase 1 Nasal Dosing in Healthy Volunteers (Safety, Tolerability and Biomarkers of Immunomodulation) August 2019 Initiate Phase 1 Oral Dosing of Foralumab in Healthy Volunteers 2H 2019 Report Top Line Safety, Efficacy and Explo
Slide 29: Financing Objectives and Planned Use of Proceeds
F I N A N C I N G OBJECTIVES PLANNED USE OF PROCEEDS OBJECTVE CAPITAL ALLOCATION Milciclib Program Advance the Clinical Development – Commence Phase 2b Clinical Trial ~$4.0 Million Foralumab Program Complete Phase 1 Oral Administration Clinical Trial - Healthy Volunteers Commence Phase 2 Nasal Admin
Slide 30: Contact Us
An Innovative Platform in Oral and Nasal Antibody Administration A Novel Approach for Treatment of Hepatocellular Carcinoma CONTACT US US Headquarters Tiziana Life Sciences Inc 420 Lexington Avenue Suite 2525 New York, NY 10170 Research and Development Center Tiziana Life Sciences Inc Pennsylvania B