Obi Pharma, Inc. · TPEX:4174
Obi Pharma — Investor Presentation (December 2023)
47 slides from Obi Pharma's investor presentation, Dec 6, 2023
Slide 1: Renewal and Growth
Renewal and Growth 2023 Investors' Meeting December 6, 2023
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation contains certain forward-looking statements. These forward-looking statements may bze 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 Opening Financial Discovery Clinical Closing Remarks Overview Development Remarks 3 December 6, 2023
Slide 4: Opening Remarks
01 Opening Remarks Chief Executive Officer Heidi Wang, Ph.D. 4 December 6, 2023
Slide 5: OBI Pharma: Renewal and Growth
OBI Pharma: Renewal and Growth Pipeline Our People Culture & Corporate Responsibility 5 December 6, 2023
Slide 6: OBI Pharma – Building the Pipeline of the Future
OBI Pharma – Building the Pipeline of the Future TARGETS Globo H, SSEA4, AKR1C3, TROP2, Nectin4, HER2 and other potential targets. Targeted Vaccine Prodrug ADC BsADC 6 December 6, 2023 mAb: monoclonal antibodies ADC: Antibody Drug Conjugates BsAb: Bi-specific antibodies BsADC: Bi-specific ADC
Slide 7: Broad Oncology Pipeline with Renewed Focus on ADC
Broad Oncology Pipeline with Renewed Focus on ADC PRODUCT TYPE TARGET CANCER DISCOVERY PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 Breast Adagloxad Vaccine Globo H (TNBC) Global Phase 3 TNBC Study Simolenin NSCLC OBI-833 Vaccine Globo H Multiple OBI-3424 Prodrug AKR1C3 Cancers Multiple OBI-866 Vaccine SSEA
Slide 8: ADC: A Novel Targeted Therapy
ADC: A Novel Targeted Therapy Linker Tumor Cell Normal Cell Drug 8 December 6, 2023
Slide 9: ADCs – the Paradigm Shifts in Cancer Therapy
ADCs – the Paradigm Shifts in Cancer Therapy More ADCs entered the clinic than $ 36B 150+deals + 400% immune checkpoint Global ADC market in 2018-2023 growth in total deal inhibitors in targeted worth 40% in preclinical value of ADC from H1 20231 by 20292 stage3 2017-20223 1 World ADC conference 202
Slide 10: Two Distinct Platforms– Plug & Play
Two Distinct Platforms– Plug & Play Cystine-Based ADC Platform Proprietary ADC Platform OBI-992 OBI-902, OBI-904, OBI-905 • Differentiated Topoisomerase I inhibitor hydrophilic linker (TOP1i) payload • Optimized DAR4 TOP1i payload • Cysteine conjugation • Proprietary enzyme technology( ) • Site-spec
Slide 11: Proprietary ADC Platform – designable
Proprietary ADC Platform – designable Potential First-in-Class & Best-in-Class ADCs OBI Next Generation ADC Technology Proprietary Site-specific For Better Enzyme conjugation any mAbs efficacy Lower Consistent Novel linker Plug & Play toxicity quality A “designable” ADC Site-specific Homogeneous ADC
Slide 12: Comprehensive Worldwide Patent Coverage
Comprehensive Worldwide Patent Coverage Russia Canada Europe China United States Korea Japan Israel Malaysia Taiwan India Philippines Thailand Singapore Brazil Chile ADC South Africa Australia Argentina New Zealand Granted Pending AKR1C3 Globo series 0 20 40 60 80 100 120 140 160 180 1. The provided
Slide 13: Experienced Drug Developers
Experienced Drug Developers Industry Experience Education Newly Established Director and Above (n=18) 81%(125/155) ◼ Biostatistics Group have advanced degrees Total ◼ Development Teams & Champions 355+ years 43 Ph.D./ MD/ Pharm.D. ◼ Project Management Average Office 19+ years 82 M.S/ M.A. 13 Decembe
Slide 14: Our Culture
Our Culture 14 December 6, 2023
Slide 15: Developing ESG as OBI's DNA: Environmental
Developing ESG as OBI's DNA Environmental In 2023, Sep 2023 In 2022, energy preliminary Moved into TBIP, an saved by 12% CO2 greenhouse environmentally vs. 2021. gas inventory friendly green completed. building 15 December 6, 2023
Slide 16: Developing ESG as OBI's DNA: Social
Developing ESG as OBI's DNA Social The welfare and vacation Certified by the The average training policies are Ministry of Education: hours per employee in OBI is a much better than 2022 was required by the Labor Standards Act. sports enterprise. 14.22 hours. Social welfare activities ▲ Supports pat
Slide 17: Developing ESG as OBI's DNA: Governance
Developing ESG as OBI's DNA Governance Ranked 2nd A diversified, among the national ISO/IEC 27001 professional and "Top 5000" Certified for independent board biotechnology Information Security Average attendance companies in 2023 rate in 2022: 94% 17 December 6, 2023
Slide 18: Financial Overview
02 Financial Overview Head of Finance Colin Kao 18 December 6, 2023
Slide 19: OBI Pharma, Inc. (4174.TWO)
OBI Pharma, Inc. (4174.TWO) www.obipharma.com Taipei TAIWAN Founded April 29, 2002 IPO on TPEx March 23, 2015 Market Cap ~US$ 613M (Nov. 30, 2023) Fund Raised at IPO ~US$ 200M Fund Raised in 2019 ~US$ 65M Melbourne San Diego Fund Raised in 2022 ~US$ 102M AUSTRALIA USA Cash on Hand ~US$ 61M (Nov. 30,
Slide 20: Discovery
03 Discovery Chief Scientific Officer Ming-Tain Lai, Ph.D. 20 December 6, 2023
Slide 21: Antibody-Drug-Conjugates (ADC)
Antibody-Drug-Conjugates (ADC) 21 December 6, 2023
Slide 22: ADC: Novel Target Therapy
ADC: Novel Target Therapy Tumor Cell Normal Cell 22 December 6, 2023
Slide 23: The Mechanism of Action of ADC after Entering Bloodstream
The Mechanism of Action of ADC after Entering Bloodstream ADC in blood circulation ADC binds to target antigen ADC-antigen complex internalized Into cancer cells Cancer cells killed 23 December 6, 2023
Slide 24: ADC Format Enables the Flexibility to Develop Novel Pipelines
ADC Format Enables the Flexibility to Develop Novel Pipelines Linker Antibody ◼ Stable in plasma ◼ Internalized by cell ◼ Tumor specific ◼ Drug release inside ◼ Unaltered target the cell binding affinity Drug ◼ High potency payload ◼ TOP1 inhibitor ◼ DNA strand breaks TROP2抗體：2021年12月自博奧信公司(Biosion,
Slide 25: ADC: The Focus of OBI Drug Development
ADC: The Focus of OBI Drug Development TROP2: Two Platforms Nectin4 & HER2: Bispecific ADC: Cys-conjugation platform GlycOBI™ platform GlycOBI™ platform OBI-992 OBI-904 GlycOBI™ platform GlycOBI™ platform OBI-902 OBI-905 TROP2: Tumor-associated calcium signal transducer. 25 December 6, 2023 Nectin4:
Slide 26: Unmet needs drive instant uptake of new ADCs
Unmet needs drive instant uptake of new ADCs TROP2 (Trodelvy ) ® Nectin4 (Padcev ) ® HER2 (Enhertu ) ® USD 1.29B USD 0.84B USD 2.78B 2023(Forecast) 2023(Forecast) 2023(Forecast) USD 0.76B USD 0.56B USD 1.61B 2022 2022 2022 Approved in 2020 Approved in 2020 Approved in 2019 26 December 6, 2023 • Sour
Slide 27: OBI-992: TROP2-Targeting ADC
OBI-992 TROP2-Targeting ADC 27 December 6, 2023
Slide 28: OBI-992: TROP2-targeting ADC with potent payload
OBI-992: TROP2-targeting ADC with potent payload Hydrophilic & cleavable peptide linker TOP1 inhibitor OBI-992 is designed to be the Best-in-Class 28 December 6, 2023
Slide 29: OBI-992 has a better in vitro profile than Trodelvy or Dato-DXd
OBI-992 has a better in vitro profile than Trodelvy® or Dato-DXd OBI-992 Trodelvy® * Dato-DXd** Binding affinity +++ ++ + Specificity to tumor antigen +++ +++ ++ Serum stability +++ + ++ Exposure +++ + ++ Pharmacokinetics Clearance +++ + ++ Half-life +++ + ++ Payload potency +++ + ++ Payload cell pe
Slide 30: OBI-992 has a better in vivo profile than Trodelvy or Dato-DXd
OBI-992 has a better in vivo profile than Trodelvy® or Dato-DXd OBI-992 Trodelvy® Dato-DXd NSCLC 100% 39% 87% CDX Pancreatic 100% 54% 85% animal models* Gastric 100% NA 96% PDX NSCLC 100% NA 80% animal model* Gastric 100% NA 85% Efficacy in drug resistance models* 100% 33% 42% PK/PD models (drug rel
Slide 31: OBI-992: IND Submitted to FDA
OBI-992: IND Submitted to FDA 31 December 6, 2023
Slide 32: OBI-902 and OBI-905
OBI-902 TROP2-Targeting ADC OBI-905 HER2-Targeting ADC 32 December 6, 2023
Slide 33: Propriotary ADC Platform: OBI-902 and OBI-905
Propriotary ADC Platform: OBI-902 and OBI-905 33 December 6, 2023
Slide 34: ADCs have better profiles than competitors
ADCs have better profiles than competitors TROP2 ADCs OBI-902 Dato-DXd Serum stability +++ + Off-target toxicity (neutrophil) + +++ Off-target FcγR mediated toxicity + +++ In vivo efficacy (TNBC CDX model)* 100 % 66 % HER2 ADCs OBI-905 Enhertu® Serum stability +++ + Off-target toxicity (neutrophil)
Slide 35: Leveraging AI to accelerate drug development
Leveraging AI to accelerate drug development Incorporating Artificial intelligence / Machine learning into OBI’s Discovery and Development Plans 35 December 6, 2023 Image adapted from https://pixexid.com/image/a-person-standing-on-a-mountain-67boxri9
Slide 36: Clinical Development
04 Clinical Development Vice President, Medical Chen-En Tsai, M.D., Ph.D. 36 December 6, 2023
Slide 37: Ongoing Clinical Trials
Ongoing Clinical Trials PRODUCT TYPE TARGET CANCER DISCOVERY PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 Breast Adagloxad Vaccine Globo H (TNBC) Global Phase 3 TNBC Study Simolenin OBI-833 Vaccine Globo H NSCLC ADC Multiple OBI-999 Globo H (ThioBridge™ conjugation) Cancers Multiple OBI-866 Vaccine SSEA4 Ca
Slide 38: Adagloxad Simolenin (OBI-822)
Adagloxad Simolenin （OBI-822） A First-in-Class Active Immunotherapy Stimulating Production of Anti-Globo H Antibodies OBI-822: Globo H covalently linked to keyhole limpet hemocyanin (KLH) 38 December 6, 2023
Slide 39: Adagloxad Simolenin Global Phase III Trial
Adagloxad Simolenin Global Phase III Trial ◼ Randomized, open-label ◼ Patients with high-risk, ◼ Primary endpoint: ◼ Ada Sim + SOC* as study early-stage Globo H- Design Objective IDFS (invasive Population treatment positive triple negative disease-free survival) ◼ SOC as control breast cancer Curren
Slide 40: GLORIA: more than 50% patients enrolled
GLORIA: more than 50% patients enrolled Target: 668 patients in 2025 140 With impact from Covid-19 125 120 and Russia-Ukraine War, *Projection 100 more sites were added to 104 help boost patient enrollment. 83 Subjects 80 Sites 60 48 40 43 20 0 2019 2020 2021 2022 2023 2025 Years *data cut-off: Oct
Slide 41: GLORIA: First Interim Analysis (Futility Only)
GLORIA: First Interim Analysis (Futility Only) Go No Go 75/187 = 40% 1st Interim primary Information Fraction endpoint analysis events* * Primary endpoint event: cancer recurrence or death 41 December 6, 2023
Slide 42: Procedure of Interim Futility Analysis
Procedure of Interim Futility Analysis: Based on interim analysis results, DSMB will recommend that – the study proceed as currently designed OR – the study be discontinued due to futility Interim analysis time point is reached Go Independent DSMB makes biostatisticians analyze the recommendation da
Slide 43: OBI-833
OBI-833 A New-Generation Active Immunotherapy Stimulating Production of Anti-Globo H Antibodies OBI-833: Globo H covalently linked to diphtheria toxin 43 December 6, 2023
Slide 44: OBI-833/821 Phase II Study (Non-Small Cell Lung Cancer)
OBI-833/821 Phase II Study (Non-Small Cell Lung Cancer) ◼ Randomized, open-label ◼ Primary endpoint: PFS Design ◼ OBI-833/821 + EGFR TKI as study Objective treatment (progression-free survival) ◼ EGFR TKI as control Population Current progress ◼ EGFR TKI changed from erlotinib to afatinib to Non-sma
Slide 45: Closing Remarks
05 Closing Remarks Chief Executive Officer Heidi Wang, Ph.D. 45 December 6, 2023
Slide 46: OBI Pharma Focused Investment in Pipeline of the Future
OBI Pharma Focused Investment in Pipeline of the Future & an Emphasis on Near Term Phase III GLORIA Study Phase III 2 Distinct ADC 1 Team GLORIA Platforms & Renewal & Study a strong ADC Growth pipeline 46 December 6, 2023
Slide 47: Thank You
Thank You ※ 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. 47 December 6, 2023