Annual Report for Investor Conference

Transcription

1 Annual Report for Investor Conference 19 th July, 2016 Nien-Yi Chen, Ph.D., Vice President

2 Safe Harbor Notice 2 The statements and contents included in this presentation that are not historical in nature are forward-looking statements. These forwardlooking statements, which may include statements regarding our future results of operations, performance, financial condition, development or marketing of our products or business prospects, are subject to risks and uncertainties and are based on our current expectations. Actual results may differ materially from those expressed or implied in these forward-looking statements for a variety of reasons. Please be cautioned not to place undue reliance on these forward-looking statements which are based on information currently available. Our forward-looking statements at this time does not create any duty of disclosure beyond that which is imposed by law, and we expressly disclaim any obligation to publicly update or revise any forecasts or forward-looking statements, whether as a result of new information, future events or otherwise.

3 Fountain Biopharma Inc. A Member of Microbio Group 3 Established in Taiwan in December Publicly quoted on the Taiwan Stock Exchange. Specialized in therapeutic mab for treating Allergic diseases, Cancers and Autoimmune diseases. Global drug development strategy The benchmark highlights Bio-tech company in Taiwan in 2015

4 Fountain s Core Platform 4 Human Antibody Platform Preclinical Ability Clinical Experience Allergy Manufacturing Process Development Core platform Oncology Analytical Method Auto-immune diseases Animal Facility Infectious diseases

5 5 Core Technology (1/3) Fully Human Antibody Libraries Well Selection of large scale of antigens > clones Beads Cancer cell Presentation of the 3D structure of antigen Naturally presented antigen Discover novel therapeutic target > clones Artificial cell Decrease non-targeted binding Nature antigen Animal Rule out non-targeted binding in whole body Discover novel therapeutic target To date, validated antibodies against more than 12 targets.

6 Core Technology (2/3) IgE-Related Platform Technology 6 IgE Knowledge Therapeutics for Allergic Diseases Specialized Assay Platform Anti-CemX Antibody Anti-IgE Antibody Unique Animal Model Many Others

7 Core Technology (3/3) Manufacturing Process Development 7 Cell Line Development Clone and Process Screening Formulation Development upto 6 g/l Upstream Process Development Product Analysis Quality Control Downstream Process Development Robust Process, High Product Quality, High Productivity

8 AAALAC Accredited Animal Center Full Accreditation Granted 8 ISO Accredited Lab SPF Facility Novel Platform Cancer (xenograft/orthotopic/metastasis) PBMC/SCID-hIgE Rheumatoid Arthritis Graft-versus-host disease Customized

9 Risk Balanced Product Pipelines 9 Name Type Target Indications Stage FB825 Humanized IgG1 CemX Segment Atopic Dermatitis Allergic Rhinitis US Phase I Completed FB317 Humanized IgG1 (Omalizumab) IgE Fc Allergic Asthma Chronic Urticaria CFDA IND reviewing FB704A Human IgG1 IL-6 Rheumatoid Arthritis Cytokine Strom Cancers Preclinical CMC/TOX in US FB121 Humanized IgG4 (Ibalizumab) CD4 HIV Infection Preclinical MCB Ready Balanced with high risk innovative pipelines and low risk biosimilars

10 Core Products 10 FB825 Long-lasting medication for IgE-related allergic diseases US phase I trial competed, approaching to phase II trial Patent secured in 12 countries covering antibody, epitope, and vaccine application. Funded 50 million NTD by MOEA FB704A Multiple indications with huge market Funded 40 million NTD by MOEA Executing Scale-up manufacturing and GLP toxicology studies in US

11 FB825 Anti-CemX Antibody Long-lasting Treatment for IgE-related Allergic Diseases

12 12 New Generation Antibody for Allergic Disease FB825 (IgE-B-cell depletion) Omalizumab (IgE neutralization) Sources: Allergens: dust mite, pollen, etc. Allergen DC MHCII TCR T H B mige PC Result A large number of inflammatory substances cause allergic reactions MC Histamine; serine proteases; leukotrienes; prostaglandins; cytokines; chemokines MC IgE FceRI

13 13 FB825 Targets to the Unique CemX Epitope on mige B Cells Free IgE mige Anti-IgE Omalizumab Anti-CemX FB825 By binding to the unique CemX segment, FB825 is not sensitive to IgE level as the result no limitation in patient selection.

14 Advantages of FB Items FB825 Omalizumab Target CemX on mige B Cells IgE Fc Mechanism of Action Depleting mige B Cells Neutralizing IgE Limitation in Patient No limitation IgE < 1500IU/ml Treatment Interval 12 weeks or more 2-4 weeks Safety Less likely to induce Anaphylaxis Warring for inducing Anaphylaxis Treatment Outcome Disease Modifying Symptom Relieving

15 Patent Status of FB825 Territory Status Patent No. Australia Granted B2 Bazile Office Action China Granted ZL Hong Kong Granted HK Macau Granted J/ EU Office Action India Office Action Indonesia Granted W Israel Granted Japan Granted Korea Granted Malaysia Office Action Mexico Approval Process Russia Granted Singapore Granted South Africa Granted 2012/09640 Thailand Office Action USA Granted IP protection for both CemX epitope and FB825 US B2

16 FB825 Phase Ia Study Design 16 A Phase 1, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of singleascending intravenous doses of FB825 Additional assessments with serum concentration of FB825, total IgE, and presence of anti-drug-antibody up to 140 days (Days 5, 14, 29, 85, 140). Cohort F E D C B A IV mg/kg (4: 3) Active: Placebo IV 0.03 mg/kg (4: 3) IV 0.3 mg/kg (7: 3) IV 1.5 mg/kg (7: 3) IV 5 mg/kg (7: 3) IV 10 mg/kg (7: 3)

17 FB825 is Safe and Well-tolerated 17 There were no deaths or TEAEs that led to early discontinuation. All TEAEs resolved by the end of the study. No significant difference in the incidence of AE between FB825 and placebo

18 FB825 Showed Excellent PK Profiles 18 Cohort T 1/2 (days) Mean ±SD 1.5 mg/kg ± mg/kg ± mg/kg ±3.16

19 Total IgE was 50% Reduced by Single Dose of FB Potentially 3 months per Dose

20 20 FB825 Therapy May Reduce 66% - 83% Cost of Current Treatment Annual Cost of current treatment Annual Cost of FB825 treatment US dollar % Reduced Dose level Twice monthly Once monthly Once every 3 months 150 mg/dose 300 mg/dose $15,384 $7,692 $2, %, 66.7% $28,368 $14,184 $4, %, 66.0% Assumption: $541 for 150 mg dose, $100 per doctor s office visit

21 Pharmaco-Economics of FB Better PD profile with potential quarterly dosing Product Target Company Status Dosing Maintenance Anti-CemX mige Fountain Phase I 12 w Mono Therapy Omalizumab IgE Roche/Novartis Approved 2-4w Ligelizumab IgE Novartis Phase II 2-4w Dupilumab IL-4Ra Regeneron/Sanofi Phase III 1-4w Market Penetration Mepolizumab IL5 GSK Approved 4 w Lebrikizumab IL13 Roche Phase III 4 w 21

22 Potential Global Market of FB Global market of allergic diseases exceeds 26 billion USD Product Target Indication Potential Market In 2020 (mus$) Omalizumab IgE Asthma, Urticaria 3,000 Dupilumab IL-4Ra Atopic Dermatitis 746 Mepolizumab IL5 Asthma 1,161 Lebrikizumab IL13 Asthma, COPD 308 Source: Adapted from DataMonitor, BioPharma Dive,

23 FB825 Anti-CemX humanized antibody Indication Advantages Over Current Product Potential Market Competitive Edge Atopic dermatitis IgE-related allergy Larger patient pools, not interfered by serum IgE Pharmaco-economics, potential quarterly dosing or longer 20-30% population have allergic conditions. Global market of allergic diseases exceeds 26 billion USD Patent protection covers target and antibody Replace current IgE related therapeutics Status US FDA Phase I 23

24 FB704A Anti-IL6 The First Fully-human Anti-IL6 antibody in Asia with Multiple Indications

25 IL6 is A Promising Drug Target 25 Multiple Indications Mechanism of Action Cancers Multiple Myeloma EV71 Virus Cytokine Strom Dengue Virus Prostate Cancer Influenza Virus Castleman's Disease FB704A CAR-T Cachexia Rheumatoid Arthritis Systemic Lupus Erythematosus Juvenile Idiopathic Arthritis Ankylosing Spondylitis Autoimmune 25

26 FB704A is More Effective than Benchmark in Inhibition of Inflammation 26 HUVAC cells Human PBMC Fibroblast-like synoviocytes (RA-FLS) Tocilizumab FB704A Isotype Control 26

27 Patent Status of FB704A 27 Territory Application Status Taiwan Granted in Sep China Office Action European Office Action USA Granted in Jan Israeli Office Action Indian Office Action Russian Office Action Korea Office Action Japan Office Action Canada Submitted Australia Submitted 27

28 Summary of Toxicology Studies 28 FB704A is well-tolerated in cynomolgus monkeys Species/ Strain Method of Administration Doses (mg/kg) Gender and No. per Group Observed Maximum Nonlethal Dose (mg/kg) Approximate Lethal Dose (mg/kg) Noteworthy Findings Testing Facility Single-Dose Toxicity Cynomolgus Monkeys IV 0, 1, 10, 100 1M, 1F 100 >100 FB704A was welltolerated in all cynomolgus monkeys at IV doses of 3 dosing groups and the NOAEL was considered to be 100 mg/kg. PharmaLegacy Laboratories, Inc. Other Toxicity Studies Cynomolgus Monkeys IM 200 µg /monkey Serum from the 3 animals from terminal blood draws were collected, pooled and subjected to purification. Charles River Laboratories

29 Potential Global Market of FB704A 29 Category Potential Market (billion US$) Anti-TNFa 30.0 Rheumatoid Arthritis 15.1 Castlemen s disease 0.7 CAR-T 15.0 Adapted from: Decision Resources, IMS, and EvaluatePharma

30 Deals of Anti-IL6 Antibody 30 Company Product Stage Licensor Upfront m$ Milestones Alder Biopharma ALD-518 Phase IIa BMS UCB CDP6038 Phase II R-Pharma N/A N/A Medimmune (AZ) MEDI5117 Pre-IND WuXi JV N/A Eleven Biotherapeutics EBI-031 IND Roche

31 FB704A Anti-IL6 human Antibody Indication Advantages Over Current Product Potential Market Competitive Edge Rheumatoid Arthritis Cancers Cytokine storm Fully human antibody with lower immunogenicity Target to ligand results better safety profile Superior efficacy and half-life over current treatments Global market of TNFa related diseases exceeds 30 billion USD Benefit for anti-tnfa non-responders (30%) Expended markets with multiple indications Status Preclinical study (CMC & Tox) 31

32 Prospect 32 Being a world leading company in developing long lasting treatment for IgE related allergic diseases. Securing market value with multiple applications of anti-il6 antibody Providing safe, efficient, convenient, and affordable solutions for patients globally.

33 Acknowledgment 33 Academia Sinica, Taiwan Dr. Tse-Wen Chang Dr. Han-Chung Wu Taiwan University Hospital Dr. Chia-Yu Chu Fountain Team And many others

34 Thank you very much For further inquiry please contact Wayne Tan at NienYi Chen at