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OBI Pharma, Inc OBI Pharma, Inc. Global Innovator in Immuno-Oncology and Targeted Cancer Therapies Advancing in the Clinic! Tillman Pearce, MD. Chief Medical Officer 39th Annual J.P. Morgan Healthcare Virtual Conference January 11th, 2021 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, among other things, strategy, goals, plans, or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this presentation, among others: 1. Pricing and product initiatives of competitors 2. Legislative and regulatory developments and economic conditions 3. Delay or inability in obtaining regulatory approvals or bringing products to market 4. Fluctuations in currency exchange rates and general financial market conditions 5. Uncertainties in the discovery, development, or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side effects of pipeline or marketed products 6. Increased government pricing pressures 7. Interruptions in production 8. Loss of or inability to obtain adequate protection for intellectual property rights 9. Litigation 10. Loss of key executives or other employees 11. Adverse publicity and news coverage OBI Pharma cautions that this foregoing list of factors is not exhaustive. There may also be other risks that management is unable to predict at this time that may cause actual results to differ materially from those in forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. OBI undertakes no obligation to update publicly or revise any forward-looking statements. Any statements regarding earnings growth is not a profit forecast and should not be interpreted to mean that OBI’s earnings or earnings per share for this year or any subsequent period will necessarily match or exceed published earnings or earnings per share forecasts of OBI Pharma, Inc. 2 Agenda 1 2 3 4 Company Globo Series AKR1C3 Key Introduction Science Science Milestones Leadership Leadership and Inflection Globo H Points Novel I-O Novel Pipeline Pro-drug 3 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 Jan. 8, ’21: ~US$910M (~NT$25.5 B) Taipei TAIWAN San Diego Fund Raised at IPO: ~US$200M (~NT$6.2B) USA Hong Kong Net Cash on Hand: ~US$100M CHINA Employees: 115 Melbourne AUSTRALIA 4 OBI data on file Experienced Global Management Team Michael Chang, PhD Kevin Poulos Chairman & CEO Chief Commercial Officer Amy Huang Frank Chen CEO OBI Pharma China Chief Financial Officer Tillman Pearce, MD Mitch Che Chief Medical Officer Chief Operating Officer Ming-Tain Lai, PhD David Hallinan, PhD Chief Science Officer VP Regulatory Affairs 5 OBI Pharma Has Evolved Into an Oncology Company With a Diversified Portfolio of Novel Therapies TARGETS: Globo H (+), SSEA-4 (+), AKR1C3 (+) Tumors Vaccine mAb ADC Targeted BiAb Prodrug CAR T 6 mAb: monoclonal antibodies ADC: Antibody Drug Conjugates BiAb: Bi-specific antibodies CAR-T: Chimeric Antigen Receptor T cell Agenda 1 2 3 4 Company Globo Series AKR1C3 Key Introduction Science Science Milestones Leadership Leadership and Inflection Globo H Points Novel I-O Novel Pipeline Pro-drug 7 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 across the cell recognition and membrane membrane adhesion 8 Zhang T, et al. Front Immunol. 2019 Jan 29;10:90. doi: 10.3389/fimmu.2019.00090. eCollection 2019. 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 series is a unique class of GSLs α3 involved in early embryogenesis and Ceramide tumor development SSEA-4 Glc Gal Fuc GalNAc Sialic Acid 9 OBI data on file Potential Roles of Globo H in Immunosuppression, Angiogenesis, and Cancer Cell Survival Signaling Lymphocytes Promotes Promotes Angiogenesis2 1 Immunosuppression Notch 1 Ub Endothelial Cells Ub Ca2+ TRAX Degradation Promotes Tumor Survival Signaling3 Tumor Shedding of Globo H Ceramide Kinase Kinase Tumor Cells Kinase Tumor Survival 1Tsai YC, et al. J Cancer Sci Ther 2013;5:264-270 2Cheng JY, et al. Cancer Res 2014;74:6856-6686 10 3Chuang PK, et al. PNAS 2019;116:3518-3523 High Globo H Expression in Common Cancers Globo H IHC H-score of various tumor tissues # Prevalence # Evaluable Cancer H-score at H-score 300 Specimens ≥100 ≥100 250 Pancreatic 72 36 50.0% 200 Esophageal 64 11 17.2% e r o c 150 Gastric 73 18 24.7% s H 100 Breast 131 17 13.0% 50 Lung 77 8 10.4% Colon 75 12 16.0% 0 Pancreatic Esophageal Gastric Breast Lung Colon Liver OBI’s Globo H Expression Assay (NeoGenomics) IDE-Approved by FDA 11 Resections + TMAs + 822-001 Samples. TMA: tissue microarray. Red bar: median score. OBI Data on File. Globo H scientific posters presented at 2020 AACR Globo H Ceramide enhances cancer cell survival Tzer-Min Kuo1, Yi-Chien Tsai1, Chin-Chan Lee1, and Jiann-Shiun Lai1 2934 1OBI Pharma, Inc., Taipei, Taiwan INTRODUCTION Enhanced colony formation activity in GHCer-treated lung cancer cells without Upregulation of IL-8, FGF2 and MCP-1 in GHCer-treated lung cancer cells MAPK inhibitor reduced effects of GHCer on cytokine production upregulation of cell proliferation • Glycans and glycosphingolipids Figure 1. Glycosphingolipids and Globo Series (GSLs) play a crucial role in tumor progression1,2 • Aberrant glycosylation is a hallmark of cancer cells3 • GSLs are glycans conjugated to 4 Sialic acid a lipid (ceramide) core Figure 8. MAPK inhibitor (PD98059) reduced GHCer activity on upregulation of cytokine production and cell Including and excluding Several receptors can be Crosslinking of several Interacting with glycans proteins from directly regulated by GSLs can induce or with proteins on other viabilit y. (A) Cell viability (B) IL-8 and (C) FGF2. A549 cells were treated with with or without 80 μM of GHCer for 72h • Globo series is a unique class microdomains GSLs present in the signaling across cells, contributing to cell membrane the membrane cell-cell recognition after being treated with 60 μM PD98059 for 1 hour. Levels of soluble protein of IL-8 and FGF2 were measured by ELISA. and adhesion of GSLs involved in early After removing GHCer, cells were further treated with erlotinib (40 μM) for 16h, whose cell viability were measured by embryogenesis and tumor MTS assay. Each experiment was repeated twice, and similar results were obtained. *P < 0.05 development 5 Figure 1 SUMMARY Globo H Plays an Essential Role in Tumor Survival • Globo-H (GH) ceramide (GHCer) enhanced B16F10 melanoma tumor growth in mice. • Globo H, a GSL, is a glycan isolated from the breast Figure 2. Globo H Plays an Essential Role in Tumor Survival • GHCer increased the GH levels on cell surface in lung cancer A549 and breast cancer cancer cell line MCF-7 that is MDA-MB-231 cells. overexpressed on a variety Figure 6. Decreased growth inhibition of GHCer–treated A549 cell with erlotinib treatment. (A) Erlotinib effects on cell of epithelial cell tumors such growth inhibition study. A549 cells were treated with various concentrations of erlotinib and cultured for 16 h. Cell viabilities • GHCer-treated MDA-MB-231 and A549 cells showed an upregulated colony formation as colon, ovarian, gastric, Figure 4. GHCer-treated cell shows an upregulated colony formation activit y. (A) GHCer increased GH levels on the were measured by MTS assay. (B) A549 cell was treated with GHCer for 72h. After removing GHCer, the expression of GH activity. surface of A549 and MDA-MB-231 cells. FACS analysis of GH was performed in 72h GHCer-treated cells using mAbVK9. (B) was determined by flow cytometry with mAb VK9 at the indicated times. (C) GHCer reduced growth inhibition by erlotinib. pancreatic, lung, prostate, and Slight reduction of cell viability in A549 and MDA-MB-231 cells by GHCer. MTS assay was performed in indicated cells at 72h A549 cell was treated with GHCer for 72h. After removing GHCer, cell viability was determined in A549 cells after erlotinib • GHCer-treated lung cancer cells showed an upregulated erlotinib resistance-related IL-8 and 6 breast cancers and has limited GHCer treatment (0, 20, 40, or 80 μM). Results depict mean ± SD of more than three independent experiments. (C) A549 treatment for 16h. Anti-GH antibody suppressed GHCer-induced cell (D) viability enhancement and production of (E) IL-8 and FGF2 cytokine production. expression in normal tissues7 and (D) MDA-MB-231 cells were treated without or with GHCer (80 μM) for 72h and assayed for their ability to proliferate (F) FGF2. A549 cells were treated with either 130 μM anti-Globo-H antibody or 80 μM GHCer or combination of both for and form colonies in soft agar for 20 days (left panel). Colonies were subsequently stained with p-iodonitrotetrazolium violet 72h. Experiment was repeated twice, and similar results were obtained. For (A) and (C), results depict mean ± SD of more than • Cell viability was significantly enhanced in GHCer-treated cells during erlotinib challenge. • Experimental data suggest (1mg/mL), and colonies larger than 6.1 μm (A549 cell) or 30.3 μm (MDA-MB-231 cell) were counted (right panel).
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