Obi Pharma, Inc. · TPEX:4174
Obi Pharma — Investor Presentation (November 2021)
40 slides from Obi Pharma's investor presentation, Nov 11, 2021
Slide 1: OBI's Advancing & Expanding
OBI’s Advancing & Expanding Michael Chang PhD Chairman & CEO Nov 11, 2021
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes,’ ‘expects,’ ‘anticipates,’ ‘projects,’ ‘intends,’ ‘should,’ ‘seeks,’ ‘estimates,’ ‘future,’ or similar expressions or by discussion of,
Slide 3: OBI Pharma, Inc. (TPEx: 4174.TW)
OBI Pharma, Inc. (TPEx: 4174.TW) www.obipharma.com Founded: April 29, 2002 IPOon TPEx: March 23, 2015 Market Cap Nov 5, ’ 21: ~US$73M ~(NT$22B) Shanghai CHINA Fund Raised in 2013: ~US$50M (~NT$1.5B) ~US$207M (~NT$6.2B) Global HQ Fund Raised at IPO: Taipei San Diego TAIWAN USA Fund Raised in 2019: ~U
Slide 4: OBI Pharma Has Evolved Into an Oncology Company With a Diversified Portfolio of Novel Therapies
TARGETS: Globo H (+), SSEA-4 (+), AKR1C3 (+), and various other potential targets Vaccine mAb ADC Targeted Prodrug CAR T BiAb OBI Pharma Has Evolved Into an Oncology Company With a Diversified Portfolio of Novel Therapies mAb: monoclonal antibodies ADC: Antibody Drug Conjugates BiAb: Bi-specific ant
Slide 5: Agenda
Agenda Sustainable Product Lines’ Affiliated development and Progresses Enterprises new layout 5
Slide 6: OBI Pharma's Diverse Cancer Pipeline
OBI Pharma’s Diverse Cancer Pipeline PRODUCT TYPE TARGET CANCER PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 Adagloxad Simolenin Vaccine Globo H Breast (TNBC) Global Phase 3 TNBC Study OBI-888 mAb Globo H Multiple Cancers OBI-999 ADC Globo H Multiple Cancers OBI-3424 Prodrug AKR1C3 Multiple Cancers OBI-833
Slide 7: Adagloxad Simolenin (OBI-822)
Adagloxad Simolenin（OBI-822） First-in-Class Active Immunotherapy Stimulating Globo H Antibodies 7
Slide 8: Adagloxad Simolenin Global Phase III Trial
Adagloxad Simolenin Global Phase III Trial Design Population Objective ◼ Randomized ◼ Patients with High- ◼ Primary endpoint: Risk, Early-Stage ◼ Open-label IDFS (Invasive Globo H-Positive disease-free survival) ◼ Standard of care as Triple-Negative the control Breast Cancer Current progress ◆ Enrol
Slide 9: OBI-888
OBI-888 First-in-Class Monoclonal Antibody Targeting Tumor Expression of Globo H 9
Slide 10: OBI-888 Phase II Study, Cohort Expansion
OBI-888 Phase II Study, Cohort Expansion Pancreatic Gastric Esophageal Colorectal Basket Cancer Cancer Cancer Cancer Cohort* ⚫ OBI-888 monotherapy at 20 mg/kg weekly ⚫ Advanced cancer; no effective SOC available; measurable disease; ECOG 0-1 ⚫ Patient tumor sample must have an H score of Globo H ≥ 1
Slide 11: OBI-999
OBI-999 Antibody-Drug Conjugate (ADC)Targeting Tumor Expression of Globo H 11
Slide 12: OBI-999 Phase II Study, Cohort Expansion
OBI-999 Phase II Study, Cohort Expansion Pancreatic Colorectal Basket Cancer Cancer Cohort* ⚫ OBI-999 monotherapy at 1.2 mg/kg on Day 1 of a 21-day cycle ⚫ Advanced cancer; no effective SOC available; measurable disease; ECOG 0-1 ⚫ Patient tumor sample must have an H score of Globo H ≥ 100 in an FDA
Slide 13: OBI-3424
OBI-3424 Small Molecule Prodrug Targeting Tumors Expressing the AKR1C3 Enzyme 13
Slide 14: OBI-3424 AKR1C3 H-score survey
OBI-3424 Survey of AKR1C3 levels in human normal and cancer tissues AKR1C3 IHC 400 300 H-score 200 100 0 Normal Normal HCC HCC Normal Gastric Normal Colon Liver Liver (stage I-IV)(stage III-IV) Stomach cancer Colon cancer TMA TMA (stage III-IV) TMA (stage III-IV) OBI-3424 Median 210Median 130 210 16
Slide 15: OBI-3424 Phase II Study, Cohort Expansion
OBI-3424 Phase II Study, Cohort Expansion Pancreatic Basket Cancer Cohort* ⚫ OBI-3424 monotherapy at 12 mg/m2 on Day 1 of a 21-day cycle ⚫ Advanced cancer; no effective SOC available; measurable disease; ECOG 0-1 ⚫ Patient tumor sample must have an H score of AKR1C3 ≥135 in an IHC Assay (NeoGenomics
Slide 16: OBI-833
OBI-833 New Generation Active Immunotherapy Stimulating Globo H Antibodies 16
Slide 17: OBI-833/821 Phase II Study (Non-small cell lung cancer)
OBI-833/821 Phase II Study (Non-small cell lung cancer) Design Population Objective ◼ Randomized ◼ Patients with Globo ◼ Primary endpoint: ◼ Open-label H-positive, inoperable, PFS (Progression- advanced or metastatic free survival) ◼ EGFR TKI therapy as NSCLC who have the control achieved PR or SD a
Slide 18: OBI-833/821 Phase II Investigator-Initiated Trial (Esophageal Cancer)
OBI-833/821 Phase II Investigator-Initiated Trial (Esophageal Cancer) Design Population Objective ◼ Randomized ◼ Patients with Globo ◼ Primary endpoint: H-positive, operable, ◼ Open-label RFS (Recurrence- locally advanced free survival) ◼ Standard of care as esophageal cancer the control who have hi
Slide 19: OBI-866
OBI-866 SSEA-4 targeting therapeutic cancer vaccine 19
Slide 20: OBI-866 Phase I Study
OBI-866 Phase I Study Design Population Objective ◼ Open-label ◼ Patients with advanced/ ◼ To evaluate safety, metastatic cancers of tolerability, the ovary, kidney, immunogenicity and brain, pancreas, preliminary efficacy breast or lung Current progress ◼ This phase 1 trial was started on Aug 25, 2
Slide 21: Agenda
Agenda Sustainable Product Lines’ Affiliated development and Progresses Enterprises new layout 21
Slide 22: OBI Pharma Affiliated Enterprises (2021) Equity investments
OBI Pharma Affiliated Enterprises(2021) Equity investments (%) OBI Pharma, Inc. ＊ OBI Pharma Obigen USA, Inc. Pharma, Inc. 100% 62% ＊ OBI Pharma Amaran Limited Biotech 100% 71% ＊ OBI 858 OBI Pharma AP Botulinun Australia Biosciences Toxin A Pty Ltd Inc. 100% 55% OBI Pharma (Shanghai) Limited CMC/CMO
Slide 23: AP Biosciences, Inc.
AP Biosciences, Inc. Developing antibody and protein drugs with an integrated technology platform designed by ourselves. 23
Slide 24: APBio bispecific antibody development timeline
APBio bispecific antibody development timeline PRODUCT Format Application 2021 2022 2023 2024 2025 2026 2027 2028 Development Partner Innovent Bi-functional wet AMD (macular degeneration) PII PIII IBI302 DME (Diabetic Macular Edema) (efficacy) (pivotal) Biologics Fc fusion (world-wide) Bi-specific T
Slide 25: AP203 (PD-L1 x CD137 Bispecific Antibody)
AP203 (PD-L1 x CD137 Bispecific Antibody) - killing PD-L1-expressing cancer cells through localized activation of T cells Mechanism of Action Indications Clinical Study Design For PD-L1-dependent activation For PD-L1-expressing locally, A multi-center, open, single- of CD137 on cytotoxic & advanced
Slide 26: AP505 (PD-L1 x VEGF Bispecific Antibody)
AP505 (PD-L1 x VEGF Bispecific Antibody) - activates T cells while inhibiting angiogenesis with one single antibody Mechanism of Action Indications Clinical Study Design To activate T cells through For locally, advanced or A multi-center, open, single- blocking of PD-1/L1, and to metastatic non-smal
Slide 27: Amaran Biotech
Amaran Biotech A contract manufacturing company established in 2010 to provide quality solutions in drug process development, analytical services and cGMP manufacturing of high- value biopharmaceuticals. 27
Slide 28: Business Plan - Milestones
Business Plan - Milestones 2013-2017 2018-2021 2022-2025 2025-2026 First Phase Second Phase Third Phase Fourth Phase DS Plant Set-up Inj Plant Set-up Inj Plant CDMO Inj Plant Expansion 1. API facility 3. Purification Suite for 5. Robotic Fill Finish Facility 6. 2nd Fill Line Protein and Natural Prod
Slide 29: Specialty Biopharma CDMO
Specialty Biopharma CDMO Biopharmaceutical Substance and Natural Product Enzymatic Carbohydrate Synthesis, Small-molecular-protein Conjugation, Isolation, Purification, Lyophilization Vaccine Adjuvant High quality plant-derived immunological adjuvant Analytical Testing for Product Release and Stabil
Slide 30: Adjuvant Business Potential Partnership with Croda
Adjuvant Business Potential Partnership with Croda Market Adjuvant QS-21 Global Marketing Technology Purification Penetration Process Global Sales Development Team Croda International; Funded 1925 FTSE100; 4,300 employees in 37 countries Revenue 2020: £ 1.39B (+0.9% Y/Y) 2018 2021 2023 2025 2018 Col
Slide 31: Obigen Pharma, Inc.
Obigen Pharma, Inc. Novel botulinum toxin for cosmetic and medical applications 31
Slide 32: OBI-858 Product Executive Summary
OBI-858 Product Executive Summary OBI-858 : Best-in-class Botulinum Type A toxin Product Plant Construction Phase I Clinical Study ▪ Drug substance and product located in Taiwan Hsinchu ▪ OBI-858-001 is a single injection, open label, dose biomedical park and Tainan science park escalation study ▪ A
Slide 33: OBI-858 Product Development Strategy
OBI-858 Product Development Strategy Short-Term Mid-Term Long-Term Cosmetics ◆ Glabellar Lines ◆ Migraine ◆ Liquid formulation ◆ Calf Reduction ◆ Cervical dystonia ◆ Room temperature ◆ Upper limb spasticity storage ◇ Frown Line ◇ Blepharoptosis ◇ Instillation dosage form ◇ Crow feet ◇ Hyperhidrosis
Slide 34: Agenda
Agenda Sustainable Product Lines’ Affiliated development and Progresses Enterprises new layout 34
Slide 35: OBI Innovation Base Sustainable development
OBI創新基地 OBI Innovation Base Sustainable development ★Research and develop ★Development second-generation OBI創新基地 of new targets products Bispecific Antibody Antibody Drug Conjugate 35
Slide 36: COVID-19
© covip-19 OB! ea R= = PHARMA jai Me
Slide 37: CAR-T
CAR-T https://askhematologist.com/car-t-cell-therapy/ 37
Slide 38: Proof of concept (in vitro results)
Proof of concept (in vitro results) Cell-1 (GH High) (GHHigh) Cell-3cytotoxicity Cell-5 (GH Low) NCI-N87 cytotoxicity MCF-7 SK-OV3 cytotoxicity 100 100 100 Cytotoxicity (%) Cytotoxicity (%) Cytotoxicity (%) 80 80 80 60 60 60 40 40 40 20 20 20 0 0 0 1 1 1 1 1 1 1 0: 5: 1: 2: 5 : 10 : 2 0: 1 :1 1 1 1
Slide 39: CAR-T cells in tumor model
CAR-T cells in tumor model Ctrl T cell CAR-T Ctrl T cell CAR-T 1st tumor cells Day 44 2nd tumor cells T or CAR T cells Day 57 1st tumor ASID002_pL5w.Puro cells 2nd tumor cells 2E6 T cells 6 2x10 T cell iv 10 12 Luminescence (Photons/sec) CtrlstT 1 tumor ctrl 10 11 2C2 CAR-T 1st tumor: Ctrl -T PBS 10
Slide 40: Thank You
Thank You www.obipharma.com