Slide 1: OBI Pharma: Innovation and Optimism
OBI Pharma Innovation and Optimism Annual Shareholders' Meeting June 17, 2024
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 discussio
Slide 3: Agenda
01 Introduction Innovation in ADC Platform Agenda 02 Discovery 03 Powerhouse TROP2 ADC Globo H Active Immunotherapy 04 05 Phase 1/2 Study Global Phase III Study 06 Financial Planning 07 CEO Closing Remarks 3 June 2024
Slide 4: 01 Introduction
01 Introduction Chief Executive Officer Heidi Wang, Ph.D. 4 June 2024
Slide 5: OBI Transformation
OBI Transformation • Evolved the Culture The OBI today is NOT the same as - Expand into global markets the OBI of yesteryears. - Explore out-licensing opportunities - Brought positive energy - Eliminated silos - Instilled a sense of urgency • P.O.P. - Pipeline & Platforms: re-building for near-term
Slide 6: Back to Basics – Pipeline & Platforms
Back to Basics – Pipeline & Platforms Innovation, Goal Setting Prioritization Inclusion, Integrity • Build and foster OBI • Set clear • Sharpen focus Innovation goals • Strengthen intellectual property • Emphasize • Terminate unproductive quality assets • Seek diversity of ideas • Put resources on t
Slide 7: Back to Basics – Organization
Back to Basics – Organization Quality Management Newly Established Training System (QMS) • Biostatistics & Data • Competitive advantage Management Group • Evolve company culture • Commitment to safety, • Development Teams & quality, compliance Champions • Strengthen technical • Efficiency and cost s
Slide 8: Back to Basics – People
Back to Basics – People Discovery Team Industry Experience Engagement n=~90 • Conduct 1:1 with every Employees (n=~163) employee Talent is the engine that Director and Above (n=21) • Enhance communication: drives OBI innovation. Director and Above (n=21) foster an open-door policy >90% have advanced
Slide 9: Building beyond Globo H Vaccines: Targets & Modalities
Building beyond Globo H Vaccines TARGETS & MODALITIES Globo H, TROP2, Nectin-4, HER2, AKR1C3 and other potential targets Therapeutic Targeted Vaccine Prodrug ADC BsADC Antibody Drug Conjugates Bispecific ADC 9 June 2024
Slide 10: 02 Innovation in Discovery
02 Innovation in Discovery Chief Scientific Officer Ming-Tain Lai, Ph.D. 10 June 2024
Slide 11: Broad Oncology Pipeline with a Focus on ADC
Broad Oncology Pipeline with a Focus on ADC MODALITY/ RECRUITING COMPOUND TARGET TUMOR TYPE DISCOVERY P1 P2 P3 PLATFORM REGION(S) Adagloxad Asia, AUS, EUR, Vaccine Globo H Breast (TNBC) Simolenin S. Africa, SA, USA OBI-833 Vaccine Globo H Lung (NSCLC) Taiwan Liver (HCC) OBI-3424 Prodrug AKR1C3 China
Slide 12: Innovation Engine Drives Drug Discovery
Innovation Engine Drives Drug Discovery From DNA to IND: streamline the path for faster delivery GMP production OBI-992 FDA Linker ADC Safe to payload mAb DSI DS & DP proceed IND Master IND cell bank filing Lead clone & candidate selection Cell line development DNA Linker payload development GLP tox
Slide 13: Deep Glycan Expertise Drives Innovation
Deep Glycan Expertise Drives Innovation Therapeutic vaccine ADC Antibody development via GlycOBITM powered by EndoSymeOBITM (OBI-822, OBI-833) (OBI-902, OBI-904) Globo H TROP2, Nectin-4, and others Enzyme Synthesis ▪ Cooperate with Academia Sinica ▪ Antibody enzymatic engineering ▪ EndoSymeOBITM: du
Slide 14: EndoSymeOBI: One-pot glycan engineering made possible
EndoSymeOBI One-pot glycan engineering made possible EndoSymeOBITM Publications Patent: Dual Functions ▪ US 11203645B2, 2019. Cleavage ▪ TW 202035444A, 2019. One-Pot ▪ PCT/US2023/074849, 2023. ▪ TW 112136209, 2023 Glycan Engineering Conjugation Paper: ▪ JACS Au, DOI: 10.1021/jacsau, 2024. 14 June 20
Slide 15: Leveraging State-of-the-Art Technology to Identify New Targets
Leveraging State-of-the-Art Technology to Identify New Targets Disease Transcriptomic Protein Database 3D organoid characterization analysis interaction Validation of potential cancer targets 15 June 2024
Slide 16: 03 ADC Platform Powerhouse
03 ADC Platform Powerhouse Director, Medicinal Chemistry David Teng-Yi Huang, Ph.D. 16 June 2024
Slide 17: Proprietary Glycan Site-Specific ADC Platform
Proprietary Glycan Site-Specific ADC Platform • PCT/US2023/074849, 2023 • Novel Linker-payload, US provisional application, 2023 Antibody Glycan Engineering Technology • Poster presentation AACR, San Diego US, Apr. 2024. Fuc Novel Linker-Payload Technology Linker N297 NH GlcNAc Sugars payload Payloa
Slide 18: Potential Best-in-Class ADCs with GlycOBI
Potential Best-in-Class ADCs with GlycOBI GlycOBI DAR8 ADC Breast Cancer – JIMT-1 Herceptin-resistant CDX model Superior in vivo antitumor activity TGI (%) vs Enhertu® 3 mg/kg Single dose Vehicle HER2 63% Enhertu® ADC 153% HER2 GlycOBI ADC GlycOBI DAR4 ADC Colorectal Cancer – DLD-1 CDX model Superio
Slide 19: Next Generation ADC Platform
Next Generation ADC Platform Glycan-based ✓ Glycan conjugation site ✓ Novel linker-payload Traditional Cysteine-based ✓ Homogeneous drug-to-antibody ratio (DAR) ✓ Improve therapeutic window MMAE Platform DXd Platform Therapeutic Probability 92 discontinued window ADCs* of success *mAbs,15(1).https:/
Slide 20: GlycOBI Plug-&-Play Platform: unlimited possibilities
GlycOBI Plug-&-Play Platform: unlimited possibilities DAR4 OBI-902 (TROP2) Bispecific DAR8 Dual Payload OBI-904 (Nectin-4) 20 June 2024
Slide 21: GlycOBI Platform Fuels Partnerships
GlycOBI Platform Fuels Partnerships In-house product development “An Ideal Match” Powered by Collaborative Technology development platform licensing 21 June 2024
Slide 22: 04 TROP2 ADC Phase 1/2 Study
04 TROP2 ADC Phase 1/2 Study Director, Development Team Wan-Fen Li, Ph.D. 22 June 2024
Slide 23: Benefits and Limitations of Leading TROP2 ADCs
Benefits and Limitations of Leading TROP2 ADCs Trodelvy® Dato-DXd A new TROP2 ADC Developer should have: • BLA submitted ▪ Improved stability Development • 2021: FDA fully approved • FDA action date ▪ Wider therapeutic window Status (Breast) target Q4 2024/ Q1 2025 ▪ Optimal dosing • Breast ▪ New in
Slide 24: OBI-992: Potential Best-in-Class TROP2 ADC by Innovative Design
OBI-992: Potential Best-in-Class TROP2 ADC by Innovative Design Linker ◼ Stable in circulation Cleavable ◼ Water soluble Linker ◼ Payload release in tumor cell Antibody* ◼ Different binding site TROP2 Antibody ◼ Better binding affinity and specificity Payload ◼ Overcome resistance Exatecan ◼ Better
Slide 25: OBI-992: Compelling Preclinical Results in Lung Cancer Model
OBI-992: Compelling Preclinical Results in Lung Cancer Model Compared to Trodelvy® and Dato-DXd Benchmark ADCs: • Trodelvy® • Poster presentation AACR, San Diego US, Apr. 2024. • Dato-DXd Better in vivo antitumor activity Higher potential to overcome drug resistance in drug efflux transporter-expres
Slide 26: Strategic Planning to Improve Probability of Technical and Regulatory Successes
Strategic Planning to Improve Probability of Technical and Regulatory Successes First-patient-enrolled Phase 2 Cohort Expansion US FDA June 11th 2024 ▪ Proof-of-concept Safe to proceed ▪ Determine an optimal dose January 2nd 2024 Phase 1 Dose Escalation ▪ Explore potential indications ▪ Advanced sol
Slide 27: 05 Globo H Active Immunotherapy Global Phase III Study
05 Globo H Active Immunotherapy Global Phase 3 Study Director, Development Team Elena Chen, M.D. 27 June 2024
Slide 28: Triple-Negative Breast Cancer (TNBC) is a Cancer with 3 HIGHS
Triple-Negative Breast Cancer (TNBC) is a Cancer with 3 HIGHS TNBC tumors are high grade, aggressive tumors with a high rate of distant metastasis and high mortality Epidemiology Prevalence • Breast cancer ranked 4th in • 33% BRCA 1-2 mutation the top 10 causes of death.* • Younger women (< 50 years
Slide 29: ADASIM: Novel Globo H Active Immunotherapy
ADASIM: Novel Globo H Active Immunotherapy OBI-822 OBI-821 Adagloxad simolenin (ADASIM) is comprised of a synthetic It is administered with OBI-821—a tumor antigen, Globo H, conjugated to a hemocyanin saponin-based immune adjuvant purified carrier protein (KLH) derived from the keyhole limpet from Q
Slide 30: ADASIM: Global Phase 3 Study
ADASIM: Global Phase 3 Study ◼ 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 *SOC: standard of ca
Slide 31: 06 Financial Planning
06 Financial Planning Director, Finance Colin Kao, CPA 31 June 2024
Slide 32: 2024H2 Outlook
2024H2 Outlook GLORIA Phase III Globo H Vaccine 2nd interim analysis 992-001 P1 trial-in-progress (US and Taiwan) Execute GlycOBI ADC platform out-licensing strategy Build strong intellectual property position for assets and platforms Next generation ADC development & comprehensive product life cycl
Slide 33: Financial Outlook
Financial Outlook Increase cashflow • Fundraising in 2024 H2 • Explore business collaboration opportunities as soon as assets and/or platforms reach their key milestones • Provide fee-for-service and out-licensing models for technology platforms Cost saving measures • Terminate trials with limited t
Slide 34: 07 CEO Closing Remarks
07 CEO Closing Remarks Chief Executive Officer Heidi Wang, Ph.D. 34 June 2024
Slide 35: OBI Pharma – Pipeline & ADC
OBI Pharma – Focused Investment on People, Pipeline, & ADC Platforms Pipeline & Operation Innovation ADC Strategy & Optimism Platforms • 822-011 • Provide new treatment • Expand in global • 992-001 options for patients in markets • TROP2 ADC need • Drive out-licensing • Nectin-4 ADC opportunities •
Slide 36: Q&A
Q&A Contact Us： Info@obipharma.com 36 June 2024