Slide 1: OBI's Advancing & Expanding
OBI’s Advancing & Expanding Michael Chang PhD Chairman & CEO Oct 12, 2022
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. (4174.TWO)
OBI Pharma, Inc. (4174.TWO) www.obipharma.com Founded: April 29, 2002 IPOon TPEx: March 23, 2015 Market Cap Jun 30, ’ 22: ~US$547M ~(NT$16.4B) Shanghai CHINA Fund Raised in 2013: ~US$50M (~NT$1.5B) San Diego Global HQ USA ~US$207M (~NT$6.2B) Fund Raised at IPO: Taipei Fund Raised in 2022: ~US$105M (
Slide 4: Experienced Global Management Team
Experienced Global Management Team Michael Chang, PhD Kevin Poulos Chief Chairman & CEO Commercial Officer Wayne Saville, MD Frank Chen Chief Medical Officer Chief Financial Officer Ming-Tain Lai, PhD Mitch Che Chief Scientific Officer Chief Operating Officer David Hallinan, PhD VP Regulatory Affair
Slide 5: OBI Pharma Has Evolved Into an Oncology Company With a Diversified Portfolio of Novel Therapies
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 Targeted Vaccine Prodrug ADC mAb BiAb CAR T mAb: monoclonal antibodies ADC: Antibody Drug Conjugates BiAb: Bi-specific ant
Slide 6: Agenda
Agenda 1 Product Line’s Progress 2 OBI Towards Sustainability 3 Affiliated Enterprises 6
Slide 7: OBI Pharma's First-in-Class Cancer Pipeline
OBI Pharma’s First-in-Class Cancer Pipeline Stage of Development PRODUCT TYPE TARGET CANCER PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 Adagloxad Vaccine Globo H Breast (TNBC) Global Phase 3 TNBC Study Simolenin OBI-999 ADC Globo H Multiple Cancers OBI-3424 Prodrug AKR1C3 Multiple Cancers OBI-833 Vaccine G
Slide 8: Adagloxad Simolenin (OBI-822)
Adagloxad Simolenin（OBI-822） A First-in-Class Active Immunotherapy Stimulating Production of Anti-Globo H Antibodies 8
Slide 9: Adagloxad Simolenin Global Phase III Trial
Adagloxad Simolenin Global Phase III Trial Design Population ◼ Randomized ◼ Patients with high-risk, early-stage ◼ Open-label Globo H-positive triple negative ◼ Standard of care as the control breast cancer Objective Current progress ◼ Enrolling sites ： ◼ Primary endpoint: USA, Taiwan, Hong Kong, Au
Slide 10: OBI-999
OBI-999 An Antibody-Drug Conjugate (ADC) Targeting Globo H-Positive Cancers 10
Slide 11: OBI-999 Phase II Study, Cohort Expansion
OBI-999 Phase II Study, Cohort Expansion Design ◼ OBI-999 monotherapy at 1.2 mg/kg on Day 1 of a 21-day cycle ◼ Patient ′s tumor sample must have an H score of Globo H ≥ 100 in an FDA IDE-approved assay (NeoGenomics) Cohort ◼ Pancreatic Cancer, Colorectal Cancer, Basket Cohort* OBI-999 Sites ◼ Phase
Slide 12: OBI-3424
OBI-3424 A Small-Molecule Prodrug Targeting Cancers Expressing the AKR1C3 Enzyme 12
Slide 13: OBI-3424 Phase II Study, Cohort Expansion
OBI-3424 Phase II Study, Cohort Expansion Design ◼ OBI-3424 monotherapy at 12 mg/m2 on Day 1 of a 21-day cycle ◼ Patient ′s tumor sample must have an H score of AKR1C3 ≥ 100 in an IHC Assay (NeoGenomics) ◼ Pancreatic Cancer, Basket Cohort* Sites OBI-999 ◼ Phase II Study Centers：5 sites in the US • *
Slide 14: OBI-3424 Phase 2 T-ALL Study sponsored by SWOG ongoing
OBI-3424 Phase 2 T-ALL Study sponsored by SWOG ongoing Clinicaltrials.gov A Phase II Study of AKR1C3-Activated Prodrug OBI-3424 (OBI-3424) in Patients With Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL) NCT04315324 14
Slide 15: OBI-833
OBI-833 A New Generation Active Immunotherapy Stimulating Production of Anti-Globo H Antibodies 15
Slide 16: OBI-833/821 Phase II Study (Non-small cell lung cancer)
OBI-833/821 Phase II Study (Non-small cell lung cancer) Design Population ◼ Randomized ◼ Patients with Globo H-positive, ◼ Open-label inoperable, advanced or metastatic ◼ EGFR TKI therapy as the control NSCLC who have achieved PR or SD after first-line EGFR TKI therapy Objective Current progress ◼ P
Slide 17: OBI-833/821 Phase II Investigator-Initiated Trial (Esophageal Cancer)
OBI-833/821 Phase II Investigator-Initiated Trial (Esophageal Cancer) Design Population ◼ Randomized ◼ Patients with Globo H-positive, ◼ Open-label operable, locally advanced ◼ Standard of care as the control esophageal cancer who have high risk for recurrence after surgery Objective Current progres
Slide 18: OBI-866
OBI-866 SSEA-4 targeting therapeutic cancer vaccine 18
Slide 19: OBI-866 Phase I Study
OBI-866 Phase I Study Design Population ◼ Open-label ◼ Patients with advanced/ metastatic cancers of the ovary, kidney, brain, pancreas, breast or lung Objective Current progress ◼ This phase 1 trial was started on Aug ◼ To evaluate safety, tolerability, 25, 2020 and is actively enrolling immunogeni
Slide 20: Agenda
Agenda 1 Product Line’s Progress 2 OBI Towards Sustainability 3 Affiliated Enterprises 20
Slide 21: OBI Towards Sustainability
OBI Towards Sustainability New generation Antibody Drug Cell Therapy COVID-19 vaccine Conjugate (ADC) OBI創新基地 21
Slide 22: BCVax
BCVax Second generation Recombinant subunit protein vaccine against SARS-CoV-2 22
Slide 23: BCVax
BCVax Antigen: Delta-S protein Adjuvant: ISCOM ◼ Improved from OBI-821 adjuvant ◼ Trimer, as natural form ◼ Nanoparticle format ◼ More stable for storage and transport ◼ Strong immunogenicity to induce antibody and T cell responses Induces high titer anti-S protein IgG and T cell response 23
Slide 24: Features of BCVax
Features of BCVax Protein-based vaccine is considered very safe Capable to induce immunity against multiple variants ◼ Including Alpha, Beta, Gamma, Delta, and Omicron ◼ As a booster can be further enhance the neutralization activity ISCOM as adjuvant to enhance immune response ◼ High IgG titers and
Slide 25: Development status
Development status Design Phase I is planned Toxicology to conduct in TW GMP production To file IND study SEP~ 2022 AUG OCT DEC 25
Slide 26: OBI TROP2 ADC
OBI TROP2 ADC New target TROP2 ADC 26
Slide 27: ADC Success Depends on Optimization of Each Component
ADC Success Depends on Optimization of Each Component TROP2 Antibody：licensed-in from Biosion, Inc. in Dec 2021 Linker Noval Antibody ◼ Stable in plasma ◼ Internalized by cell ◼ Tumor specific ◼ Drug release inside the cell ◼ Unaltered target bindingaffinity Drug ◼ High potency payload ◼ TOP1 inhibi
Slide 28: OBI TROP2 ADC vs. Trodelvy
OBI TROP 2 ADC vs. Trodelvy™ OBI TROP2 mAb Sacituzumab Binding affinity (KD) +++ +++ Exposure (AUC) +++ ++ Pharmacokinetics Clearance +++ ++ Half-life +++ ++ OBI TROP2-ADC Trodelvy™ Linker stability +++ + Cytotoxicity of payload +++ ++ Resistance to payload ++ +++ Adverse side effects of payload ++
Slide 29: OBI TROP2 ADC Development Timeline
OBI TROP 2 ADC Development Timeline Animal IND Phase I/II Kickoff GLP GMP DS/DP PD/PK Submission Study Toxicology production studies 2022 2023 2024 29
Slide 30: Cell Therapy
Cell Therapy 30
Slide 31: In vivo efficacy and persistence in N87 gastric cancer model
In vivo efficacy and persistence in N87 gastric cancer model 1st N87 tumor 1st N87 tumor injection cells injection 2nd N87 tumor nd Ctrl-T/ CAR-T 2 N87 ASID002_pL5w.Puro 2E6tumor T cells injection T cell injection injection cells injection Ctrl T Luminescence (Photons/sec) 10 12 2C2 CAR-T Ctrl-T CAR
Slide 32: Advantage of OBI Globo H CAR-T
Advantage of OBI Globo H CAR-T Unique and novel target for cancer therapy Efficacy dose close to clinical therapeutic zone Persistence for persistent tumor killing Safe for tumor specific targeting Memory for immune organ homing 32
Slide 33: CAR T Development Timeline
CAR T Development Timeline Tech Transfer to Laboratory Scale GMP Facility/ IND GMP Clinical Process/ Enabling Scale Production Analytical Tech Manufacturing Transfer Pre-IND and Pre-clinical 2022 2023 IND Filing 33
Slide 34: Agenda
Agenda 1 Product Line’s Progress 2 OBI Towards Sustainability 3 Affiliated Enterprises 34
Slide 35: OBI Pharma Affiliated Enterprises (2022) Equity investments
OBI Pharma Affiliated Enterprises (2022) Equity investments OBI Pharma, Inc. AP Amaran Obigen Odeon OBI Pharma OBI Pharma OBI Pharma Biosciences Biotech Pharma, Inc. Therapeutics Australia USA, Inc. Limited Inc. OBI 858 (Cayman) Pty Ltd Bi-specifics CMC/CMO Botulinun Toxin A Limited 100% 100% 100% 4
Slide 36: AP Biosciences, Inc.
AP Biosciences, Inc. 36
Slide 37: APBio Bispecific Antibody Development Timeline
APBio Bispecific Antibody Development Timeline PRODUCT Format Application 2021 2022 2023 2024 2025 2026 2027 2028 Development Partner Innovent Biologics Bi-functional Fc wet AMD (macular degeneration) PII PIII IBI302 DME (Diabetic Macular Edema) (efficacy) (pivotal) (world-wide) fusion Bi-specific T
Slide 38: 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 For PD-L1-dependent activation of CD137 on cytotoxic & memory T cells in the tumor microenvironment, and to bridge the activated T cells to the cancer cells f
Slide 39: 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 To activate T cells through blocking of PD-1/L1, and to promote lymphocyte infiltration into the tumor through inhibition of VEGF pathway, to enhance tumor toxic ef
Slide 40: Obigen Pharma, Inc.
Obigen Pharma, Inc. 40
Slide 41: OBI-858 Product Executive Summary
OBI-858 Product Executive Summary OBI-858 : Best-in-class Botulinum Type A toxin Product Plant ◼ Drug substance and product located in Taiwan ◆ Plant design will meet CDC and cGMP Construction Hsinchu biomedical park and Tainan science park regulations ◼ A State-of-the-art PIC/s cGMP facility with h
Slide 42: OBI-858 Product Development Strategy
OBI-858 Product Development Strategy Short-Term Mid-Term Long-Term ◆ Migraine ◆ Liquid formulation ◆ Glabellar Lines ◆ Cervical dystonia ◆ Room temperature ◆ Calf Reduction storage ◆ Upper limb spasticity ◇ Frown Lines ◇ Crow ′s feet ◇ Instillation dosage form ◇ Blepharoptosis ◇ Facial Slimming ◇ Lo
Slide 43: Amaran Biotech
Amaran Biotech 43
Slide 44: Fully Automatic Robotic Aseptic Filling Line
Fully Automatic Robotic Aseptic Filling Line Gloveless Robotic Isolator Single Use Consumable Vial, Pre-filled Syringe and Cartridge Inert Air Replacement High Filling Accuracy Integrate with Lyophilizer Low Product Loss 44
Slide 45: Thank You
Thank You www.obipharma.com ※ New drug development requires long process, vast investments and with no guarantee in success which may pose investment risks. The investors are advised to exercise caution and conduct thorough evaluation.