Slide 1: OBI Pharma, Inc. Global Innovator in Immuno-Oncology
OBI Pharma, Inc. Global Innovator in Immuno-Oncology and Targeted Cancer Therapies Advancing in the Clinic! QIC CEO Week 2023
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: Agenda
Agenda 1 2 3 4 Company Globo H AKR1C3 Key Introduction Science Science Milestones Leadership Leadership and Inflection Points Novel I-O Novel Pipeline Pro-drug 3
Slide 4: OBI Pharma, Inc. (TPEx: 4174.TWO)
OBI Pharma, Inc. (TPEx: 4174.TWO) www.obipharma.com Founded: April 29, 2002 Shanghai CHINA IPO on TPEx: March 23, 2015 Global HQ Market Cap 20 Apr, ’23: ~US$ 660M (~NT$ 19.8B) Taipei TAIWAN San Diego Fund Raised at IPO: ~US$ 200M (~NT$ 6.2B) USA Hong Kong Net Cash on Hand: ~US$ 90M CHINA Employees:
Slide 5: Experienced Global Management Team
Experienced Global Management Team Yen Yun, MD, PhD Kevin Poulos Chairman & CEO Chief Commercial Officer Wayne Saville, MD Frank Chen Chief Medical Officer Chief Financial Officer Ming-Tain Lai, PhD Mitch Che Chief Science Officer Chief Operating Officer David Hallinan, PhD VP Regulatory Affairs 5
Slide 6: Agenda
Agenda 1 2 3 4 Company Globo H AKR1C3 Key Introduction Science Science Milestones Leadership Leadership and Inflection Points Novel I-O Novel Pipeline Pro-drug 6
Slide 7: Functions of Glycosphingolipids (GSLs)
Functions of Glycosphingolipids (GSLs) A B C D Including and Several receptors Crosslinking of Interacting with glycans excluding can be directly several GSLs can or with proteins on other proteins from regulated by GSLs induce signaling cells, contributing to cell- microdomains present in the cell
Slide 8: Glycans, Glycosphingolipids and Cancer
Glycans, Glycosphingolipids and Cancer • Glycans and glycosphingolipids (GSLs) play a crucial role in tumor progression Globo Series GSLs β3 • Aberrant glycosylation is a hallmark of Ceramide cancer cells SSEA-3 • GSLs are glycans conjugated to a lipid α2 (ceramide) core Ceramide Globo H • Globo ser
Slide 9: Potential Roles of Globo H in Immunosuppression, Angiogenesis, and Cancer Cell Survival Signaling
Potential Roles of Globo H in Immunosuppression, Angiogenesis, and Cancer Cell Survival Signaling Lymphocytes Promotes Promotes Angiogenesis2 Immunosuppression1 Notch 1 Ub Endothelial Cells Ub Ca2+ TRAX Degradation Promotes Tumor Tumor Shedding of Survival Signaling3 Globo H Ceramide Kinase Kinase
Slide 10: High Globo H Expression in Common Cancers
High Globo H Expression in Common Cancers Globo H IHC H-score of various tumor tissues Prevalenc # Evaluable e at Cancer 300 Specimens H-score ≥100 250 NSCLC (adeno) 45 49% Ovarian 118 33% 200 Pancreatic 139 32% H-score Gastric 133 26% 150 Colon 191 21% 100 NSCLC (SCC) 28 18% Cervical (adeno) 20 15%
Slide 11: Globo H expression associates with poor survival in gastric cancer
Globo H expression associates with poor survival in gastric cancer Disease specific survival (DSS) Overall survival (OS) 11 AACR 2022 Poster #6138
Slide 12: High Globo H expression correlates with higher levels of PD-L1 protein in cancer cells
High Globo H expression correlates with higher levels of PD-L1 protein in cancer cells Renal Cell TKI-resistant Gastric Cancer Gastric Cancer Breast cancer Carcinoma NSCLC 12 AACR 2022 Poster #6138
Slide 13: OBI Pharma's Innovative Cancer Pipeline
OBI Pharma’s Innovative Cancer Pipeline Stage of Development PRODUCT TYPE TARGET CANCER DISCOVERY PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 Adagloxad Breast Global Phase 3 TNBC Study Vaccine Globo H Simolenin (TNBC) Multiple OBI-999 ADC Globo H Cancers Multiple OBI-833 Vaccine Globo H Cancers Multiple OB
Slide 14: Adagloxad Simolenin
Adagloxad Simolenin First-in-Class Active Immunotherapy Stimulating anti-Globo H Antibodies 14 14
Slide 15: Adagloxad Simolenin (A-S): Globo H Vaccine
Adagloxad Simolenin (A-S): Globo H Vaccine Adagloxad simolenin is comprised of a synthetic tumor It is administered with OBI-821—a saponin- antigen, Globo H, conjugated to a hemocyanin carrier based immune adjuvant purified from protein (KLH) derived from the keyhole limpet Quillaja saponaria tree b
Slide 16: MOA of Therapeutic Vaccine Adagloxad Simolenin
MOA of Therapeutic Vaccine Adagloxad Simolenin • Globo H antigen is phagocytosed by the dendritic cell which processes it and transports it to the lymph node where they present the antigen to immature CD8+ T cells, activating them so that they can migrate to the tumor • The dendritic cells also acti
Slide 17: Adagloxad Simolenin Phase 2 Metastatic Breast Cancer study published in JITC
Adagloxad Simolenin Int’l Phase 2 Metastatic Breast Cancer study published in JITC Peer reviewed journal 17 Huang et al. J Immunother Ca 2020;8:e000342
Slide 18: Learnings From Adagloxad Simolenin Phase II Trial in MBC
Learnings From Adagloxad Simolenin Phase II Trial in Patients with Metastatic Breast Cancer (MBC) Higher Globo H tumor Higher anti-Globo H Patients receiving Next study: expression correlated IgG levels correlated full treatment Homogenous, e.g., with improved PFS with improved PFS had improved PFS
Slide 19: Phase 3 Randomized Study of Adagloxad Simolenin in TNBC
Phase 3, Randomized, Open-Label Study of the Anti-Globo H Vaccine Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients with High-Risk, Early-Stage Globo H-Positive Triple-Negative Breast Cancer 19 Clinicaltrials.gov. Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuva
Slide 20: Globo H Expression in Triple Negative Breast Cancer
Globo H Expression in Triple Negative Breast Cancer GH+ tumor Stroma Capillary GH+ tumor GH+ TILs Fat GH- tumor White 57-year-old female with infiltrating ductal carcinoma White 59-year-old female with papillary carcinoma H-score = 300 H-score = 185 GH expression level was assessed, and results are
Slide 21: Phase 3 TNBC Study Design
Phase 3 TNBC Study Design R A OBI-822/OBI-821 + SOC N S D F U Tissue Globo H O O L R M 1:1 G submission 2 weeks analysis I Treatment Period 2 Years L E Z N = 668 O W Follow-Up 3 Years R for Globo H A (150 centers: 2-year recruitment) (H score ≥15) - Y T U Approx. 40% I P O N SOC Key Eligibility Crit
Slide 22: Phase 3 TNBC Study Objectives
Phase 3 TNBC Study Objectives Primary Objective Exploratory Objectives • To determine the effect of adagloxad simolenin • To explore the association between the (AS) treatment on improving IDFS in the study anti-Globo H antibody response to AS and IDFS population and OS Secondary Objectives • To eva
Slide 23: The GLORIA Study
The GLORIA Study: A Phase 3, Randomized, Open-Label Study of the Anti-Globo H Vaccine Adagloxad Simolenin/OBI-821 in the Adjuvant Treatment of Patients With High-Risk, Early-Stage, Globo H—Positive, Triple-Negative Breast Cancer
Slide 24: Adagloxad Simolenin Global Phase 3 Trial Investigator Site Locations
Adagloxad Simolenin Global Phase 3 Trial Investigator Site Locations Russia Poland Spain EU Ukraine China Korea USA Taiwan Mexico Hong Kong Brazil Australia Peru S. Africa Enrolling sites 24 OBI data on file
Slide 25: OBI-833
OBI-833 Cancer Vaccine Targeting Tumor Expression of Globo H 25
Slide 26: OBI-833
OBI-833 OBI-833 + the saponin adjuvant OBI-821 is a therapeutic vaccine targeting Globo H ceramide in a variety of epithelial tumors Innovative Glycoprotein Saponin adjuvant OBI-821 Linker Globo H CRM-197 + OBI-833 OBI-821 Comprises a fully synthetic tumor antigen (Globo H) Induces humoral and cell-
Slide 27: Encouraging Phase 1 NSCLC cohort expansion results
Encouraging Phase 1 NSCLC cohort expansion results • OBI-833 demonstrated a favorable safety profile. • OBI-833 elicited a beneficial immune response in NSCLC patients and rendered some TKI-treated patients durable stable disease status. • The median progression-free survival was 38.1 weeks. • 11 of
Slide 28: OBI-833 P1 study published at ESMO
OBI-833 P1 study published at ESMO 28 ESMO 2020
Slide 29: OBI-999
OBI-999 Antibody-Drug Conjugate (ADC) Targeting Tumor Expression of Globo H 29
Slide 30: OBI-999 Targeting Tumor-Specific Globo H
OBI-999 Targeting Tumor-Specific Globo H Proprietary Novel Site-Specific Improved Homogeneity vs Adcetris Linker Technology ThioBridge® OBI-999 Adcetris 100 100 80 80 60 60 % % 40 40 20 20 0 0 0 1 2 3 4 5 6 7 8 0 1 2 3 4 5 6 7 8 DAR Species DAR Species Maintains the stability of the antibody and a c
Slide 31: OBI-999 Strong Anti-Tumor Effects in Cancer Models
OBI-999 Strong Anti-Tumor Effects in 4 Cancer Models CANCER TUMOR MODEL TREATMENT ANTI-TUMOR EFFECT AT TYPE DURATION TOP DOSE Pancreatic HPAC QW x 4 Tumor Free Tumor Free Gastric NCI-N87 QW x 4 (achieved at both 3 and 10 mg/kg) Lung PDX LU-01-0266 QW x 4 Tumor Free Breast MCF7 QW x 6 or Q3W x 2 Tumo
Slide 32: OBI-999 Strong tumor growth inhibition in NCI-N87 Gastric xenograft
OBI-999 Strong tumor growth inhibition in NCI-N87 Gastric carcinoma xenograft N C I- N 8 7 x e n o g r a f t ( A B 6 7 8 3 5 ) Globo H expression: 57%. 2000 V e h ic le ( Q W X 4 ,IP + IV ) O B I- 9 9 9 , 1 m g /k g ( Q W x 4 , IV ) O B I- 9 9 9 , 3 m g /k g ( Q W x 4 , IV ) 1500 O B I- 9 9 9 , 1 0
Slide 33: OBI-999 Strong tumor growth inhibition in HPAC pancreatic xenograft
100 OBI-999 Strong tumor growth inhibition in -7 1 HPAC pancreatic cancer xenograft model 6 Days 9 12 16 HPAC xenograft (OBI-20180927) 3000 Globo H expression: 97%. Vehicle OBI-999 1mpk, IV, QWKx4 2500 OBI-999 3mpk, IV, QWKx4 Tumor volume (mm3) OBI-999 10mpk, IV, QWKx4 OBI-999 at 3 mg/kg: 2000 TGI 3
Slide 34: Initiation Phase 2 portion of study November 2021
Initiation Phase 2 portion of study November 2021 ⚫ Subject number: 3+3 design, up to 30 (sequential enrollment); ⚫ Treatment cycle: 21-day cycle up to 35 cycles (approximately 2 years); ⚫ SRC: review safety and PK data after each cohort completes the 1st cycle. ⚫ Patient tumor sample must have an H
Slide 35: First-in-Human Study of OBI-999 (ASCO 2022)
OBI First-in- Human Study of OBI-999, a Globo H-Targeting Antibody-Drug Conjugate, SHARMA in Patients With Advanced Solid Tumors Apostolia Maria Tsimberidou*, Henry Hiep Vo?, Jennifer Beck, Chi-Sheng Shia?, Pei Hsu2, Tillman E. Pearce? 3029 ASCO 2022 O of | a The Uni f Tex n, TX, USA; 2081 Pharma ln
Slide 36: OBI-999 and Keytruda combo synergy poster at AACR 2023
OBI-999 and Keytruda combo synergy poster at AACR 2023 36 AACR 2023 Poster #5946
Slide 37: OBI-999 and pembrolizumab synergistic antitumor effect in four cancer models
Combination of OBI‐999 and pembrolizumab showed synergistic antitumor effect in four cancer models (breast, gastric, lung, colon) various cell‐derived xenograft models 37 AACR 2023 Poster #5946
Slide 38: Agenda
Agenda 1 2 3 4 Company Globo H AKR1C3 Key Introduction Science Science Milestones Leadership Leadership and Inflection Points Novel I-O Novel Pipeline Pro-drug 38
Slide 39: OBI-3424
OBI-3424 Small Molecule Prodrug Targeting Tumors Expressing the AKR1C3 Enzyme 39
Slide 40: The Prodrug OBI-3424 Is Converted to Active Drug in AKR1C3 Expressing Tumor Cells
The Prodrug OBI-3424 Is Converted to Active Drug in AKR1C3 Expressing Tumor Cells 40 Poster # 387 ASCO2020 Virtual Annual Meeting
Slide 41: AKR1C3 Prevalence in Cancer Types
AKR1C3 Prevalence in 10 Cancer Types Prevalence of H-score ≥135 400 AKR1C3 IHC H-score 300 200 135 100 0 ng r al ca r nx r G ac C m cC A P nC A A er r C on r c r as r A A ng A C so gu C ea A or Ov ary o C B ic C A e L u ce e Li ive e e v en m HC TM or ri TM N olo TM Lu M al ia TM TM ag TM C ha SC C
Slide 42: OBI-3424 strong anti-tumor activity against Liver, Pancreatic, Gastric and Lung cancers
OBI-3434 also demonstrated strong anti-tumor activity against Liver, Pancreatic, Gastric and Lung cancers Liver Cancer Pancreatic Cancer Lung Cancer Gastric Cancer ASCO 2020 Poster #387 AACR 2021 Poster #1220
Slide 43: OBI-3424-001: Study Schematic and Current Status
OBI-3424-001: Study Schematic and Current Status Phase 1 Dose-Escalation Phase Phase 2 Expansion Phase Completed Ongoing OBI-3424 (1.0 mg/m2 to 14.0 mg/m2) Stage 1 Stage 2 administered by IV infusion on Days 1 and 8 of each 21-day cycle or Day 1 of Pancreatic Pancreatic Considered each 21-day cycle.
Slide 44: Safety, Pharmacokinetics, and Clinical Activity of OBI-3424 Phase 1 (ASCO 2022)
re) BI Safety, Pharmacokinetics, and Clinical Activity of OBI-3424, an AKR1C3 Activated Prodrug, in Patients —_ With Advanced or Metastatic Solid Tumors: A Phase 1 Dose-Escalation Study Pei Hsu®, Tillman E, Pearce* aria Tsimberidou’, Claire F. Verschr: Henry Hiep Vo!, Jennifer Beck?, Chi-Sheng PHARM
Slide 45: OBI-3424 and pembrolizumab combo in multiple cancers
OBI-3424 and pembrolizumab combo in multiple cancers AACR 2022. Poster #6111.
Slide 46: Significant Reduction in Leukemia Bone Marrow Infiltration With OBI-3424 in PDX Model
Significant Reduction in Leukemia Bone Marrow Infiltration With OBI-3424 in PDX Model (T-ALL 31) Control OBI-3424 “OBI-3424 is one of the most Group Group effective drugs we have ever %huCD45+ in the PB tested against T-ALL in over 12 years of evaluating drugs at Significant the Children’s Cancer In
Slide 47: OBI-3424 Phase 2 T-ALL Study sponsored by SWOG ongoing
OBI-3424 Phase 2 T-ALL Study sponsored by SWOG ongoing ClinicalTrials.gov Identifier: NCT04315324. A Phase II Study of AKR1C3-Activated Prodrug OBI-3424 (OBI-3424) in Patients With Relapsed/Refractory T-Cell Acute 47 Lymphoblastic Leukemia (T-ALL)
Slide 48: Agenda
Agenda 1 2 3 4 Company Globo H AKR1C3 Key Introduction Science Science Milestones Leadership Leadership and Inflection Points Novel I-O Novel Pipeline Pro-drug 48
Slide 49: Projected Clinical Data in 2023-25
Projected Clinical Data in 2023-25 1st-in-class Oncology products Adagloxad Enrollment Simolenin Global Phase 3 TNBC Study Ends Globo H Vx 2021 2022 2023 2024 2025 OBI-999 Phase 2 Phase 2 Phase 1 Globo H ADC (Stage 1) (Stage 2) OBI-3424 Phase 2 Phase 2 AKR1C3 Phase 1 (Stage 1) (Stage 2) small molecu
Slide 50: OBI Partnering Strategy
OBI Partnering Strategy Innovative Cancer Portfolio Solidify commercial licensing and/or scientific study collaborations to maximize our portfolio value • Regional or Global Licensing • Commercial partnerships • R & D combination study collaborations • Strategic alliances Globo Series / Globo H Immu
Slide 51: Thank You
Thank You For further information please contact: THANK YOU! Celeste Chuang, DPhil Sr Manager, Business Development cchuang@obipharma.com http://www.obipharma.com/ 51