Genexine, Inc. · KRX:095700
Genexine — Investor Presentation (January 2023)
30 slides from Genexine's investor presentation, January 2023
Slide 1: Saving Lives Through Innovation
Saving Lives Through Innovation Corporate Presentation January 2023 Copyright 2023. Genexine, Inc.
Slide 2: Disclaimer
Disclaimer This Presentation has been prepared by Genexine Inc.for the purpose of setting out certain confidential information in respect of Genexine’s business activities and strategy. References to this Presentation include any information which has been or may be supplied in writing or orally in
Slide 3: Overview: A New Era of Growth and Opportunity
Overview A New Era of Growth and Opportunity Corporate Highlights • Embracing a positive change in direction, leadership & shareholder value • Targeting product commercialization and global growth • Targeting launch of first commercial products in the next 12-24 months • Unlocking value with global
Slide 4: Investment Thesis
Investment Thesis 1. Focusing on Commercialization • Multiple late stage products are positioned for commercial launch in the next 12-24 months → 1st BLA submission expected in 2023 2. Global Expansion • To expand global drug development capabilities, leverage clinical data worldwide, gain access to
Slide 5: Investment Thesis: Commercialize key assets
Investment Thesis Priority 1 Commercialize key assets Key Product Launches drive 12-36 month value generation Expected Key Products poised to enter market Clinical Trial Market Launch Best-in-class GX-H9 Ph3 enrollment completed in China Long-acting growth hormone 2023 ~ 2025 Best-in-class Ph3 enrol
Slide 6: Investment Thesis: Global Expansion
Investment Thesis Priority 2 Global Expansion Rationale for expanding outside Korea? What does it bring us? To conduct clinical development GLOBALLY - Genexine must run global clinical trials with our products to maximize value and reach patients, worldwide. - Specifically, global expansion (initial
Slide 7: Investment Highlights: Management team
Investment Highlights Talented management team & experts in biopharma industry President & CEO President, R&D CFO Neil K. Warma Jungwon Woo Sung-June Hong Univ. of Toronto HBSc, Neuroscience Yonsei Univ. MBA SNU MS Pharmacology York Univ. MBA Vanderbilt Law School LLM Cornell Univ. PhD. Microbiology
Slide 8: Neil Warma: New CEO - Industry Leader
Investment Highlights Neil Warma: New CEO - Industry Leader 2019-2022 I-Mab: U.S. GM/CEO (public) - Global Immuno oncology company - Offices: Shanghai, Beijing, San Diego, Maryland, Hong Kong 2017-2019: CEO for 2 MD Anderson oncology spin-outs (private) - Led two oncology start-ups from MD Anderson
Slide 9: Investment Highlights: 6 month achievements
Investment Highlights: 6 month achievements Recent achievements have focused on executing value-adding clinical milestones 2022 May Jun Jul Aug Sep Oct Nov Dec GX-188E Ph 2 Ph 2 top line CSR (cervical cancer) completed results (ESMO) completion GX-188E Ph 2a (SCCHN) Ph 2a (SCCHN) (head and neck FPI
Slide 10: Phase to gear up shareholder's value
Investment Highlights Phase 1 ~ 3 to gear up shareholder’s value Globalization together with commercialization will fuel shareholder return • Additional commercial launches • Revenue generation • M&A • Dual listing Theoretical Valuation • Commercialize first products • Pipeline expansion • Open US s
Slide 11: Genexine's Pipeline
Genexine’s Pipeline • Deep pipeline with near term market launches
Slide 12: Robust & Prioritized Pipeline
Robust & Prioritized Pipeline Numerous Catalysts Candidate MOA Indication Preclinical Phase 1 Phase 2 Phase 3 Commercial Collaborator Prioritized Pipeline GX-E4 Long-acting erythropoietin CKD-induced anemia GX-H9 Long-acting human growth hormone Pediatric(adult) growth hormone deficiency Therapeutic
Slide 13: GX-188E DNA Vaccine for Cervical Cancer and SCCHN
GX-188E DNA Vaccine for Cervical Cancer and SCCHN First-in-Class Drug Candidate
Slide 14: Final Phase 2 result
Final Phase 2 result GX-188E Phase 2 data in advanced cervical cancer 1. Markedly improved the ORR versus Keytruda monotherapy: • PD-L1 positive (39% vs 12.2%), PD-L1 negative (29.0% vs 0%) 2. The mOS in patients with relapsed end-stage cervical cancer is ~6 months • With Keytruda monotherapy treatm
Slide 15: Final Phase 2 result (cont'd)
Final Phase 2 result (cont’d) GX-188E Encouraging results compared with SoC ▪ Efficacy: Patients with relapsed end-stage cervical cancer show improved efficacy (ORR/mOS) compared with currently approved therapies ▪ Safety: Safety and tolerance equivalent to Keytruda monotherapy * Accelerated approva
Slide 16: GX-188E DNA Vaccine for Cervical Cancer and SCCHN
GX-188E DNA Vaccine for Cervical Cancer and SCCHN Therapeutic DNA Vaccine against HPV-based diseases ⚫ Therapeutic DNA Vaccine for HPV genotypes 16 & 18 (responsible for 70% of cervical cancer) ⚫ Rationally designed DNA vaccine to enhance HPV 16/18, E6- and E7-specific CD8 + T cell responses ⚫ Elect
Slide 17: Expected Global Clinical Development Plan
GX-188E DNA Vaccine for Cervical Cancer and SCCHN Expected Global Clinical Development Plan 2022 2023 2024 2025 2026 2027 Category 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q Clinical Study (Phase 2 in KR) Phase 2 in KR Cervical Cancer (n=60) (top-line completed) Primary
Slide 18: GX-I7 Long-acting Interleukin 7 (efineptakin alfa)
GX-I7 Long-acting Interleukin 7 (efineptakin alfa) First-in-Class T-cell amplifier
Slide 19: GX-I7 Long-acting Interleukin 7 T-cell amplifier
GX-I7 Long-acting Interleukin 7 T-cell amplifier First-in-class with significant potential in multiple cancers Work in Combination with CPI Combinations to Overcome Wide Range of Indications CAR-T Combinations Maintain the Good Safety Profile in Combinations Chemo/Radiation Combinations Copyright 20
Slide 20: PoC by dose: Promising Efficacy & Safety in mTNBC
GX-I7 Long-acting Interleukin 7 T-cell amplifier PoC by dose: Promising Efficacy & Safety in mTNBC ALC ** 12000 GX-I7+Keytruda VS Keytruda (mTNBC Patients) A b s o lu te ly m p h o c y te c o u n t s (/m m ) 3 6000 * 5000 GX-I7 (Genexine) KEYTRUDA (MSD) 4000 * 3000 ≥ 2L Keynote-899 [Keynote-086] [Ke
Slide 21: GX-H9 Long-acting Growth Hormone for Pediatric and Adult GHD
GX-H9 Long-acting Growth Hormone for Pediatric and Adult GHD Best-in-Class Drug Candidate with dosing advantage and strong growth data
Slide 22: GX-H9 Long-acting Growth Hormone: Phase 3 ongoing in China
GX-H9 Long-acting Growth Hormone Phase 3 on-going in China Current marketed products Genexine GX-H9 Daily (365 treatments/year) Weekly (52 times/year} Growth data comparison, 1yr vs 2yr average growth aHV at 1st and 2nd year by doses Switching to GX-H9 at 1 year 16 Mean (SD) Annualized Height Veloci
Slide 23: GX-H9 Long-acting Growth Hormone: Business Structure
GX-H9 Long-acting Growth Hormone Business Structure Early stage development Global development Global market Ph3 in China (on going) • China (excl. HK, Macau, Taiwan) L/O • Strategic alliance with Jumpcan • BLA submission expected 1H ‘24 Pharmaceuticals for co-promotion in China • BLA Approval expec
Slide 24: GX-E4 Long-acting erythropoietin
GX-E4 Long-acting erythropoietin Long-acting EPO with superior sustainability, efficacy, safety and price competitiveness
Slide 25: GX-E4 Long-acting EPO for CKD-induced anemia
GX-E4 Long-acting EPO for CKD-induced anemia Phase 3 completed, BLA submissions upcoming EPO (Erythropoietin) Competitiveness Anemia treatment Long-acting EPO drug with superior sustainability, 1st Gen 2nd Gen 3rd Gen efficacy, safety and price competitiveness 3 shots/wk 1 shot/wk Bi-weekly/monthly
Slide 26: Business Focus and Upcoming Milestones
Business Focus and Upcoming Milestones
Slide 27: Investment Asset
Investment Asset Providing revenue & access to global markets • Value increase through L/O (upfront, milestone, royalty) together with Strategic Investment • Sharing of clinical data → Faster time to Market → Reduce R&D costs Asia/EU/MENA Greater China North & South America Genexine • Commercialize
Slide 28: Globalization
Globalization Footprint in 3-4 years Globalization combined with clinical development capability Global Footprint Financial Strength • Multiple locations focused on • Revenue Generating global drug development • Strong Cash Balance • Listed on two stock exchanges • Tremendous growth in Valuation U.S
Slide 29: Five Investment Rationales
Five Investment Rationales Poised for growth and value generation 1. Pursuing a global path to drug development • Enabling it to leverage global markets, technology & capital 2. In a position to commercialize over the next 2 ~3 years • First product to be commercialized with solid platform technolog
Slide 30: Copyright 2023. Genexine, Inc.
Copyright 2023. Genexine, Inc.