Tiumbio Co., Ltd. · KRX:321550
Tiumbio — Investor Presentation (January 2024)
29 slides from Tiumbio's investor presentation, Jan 26, 2024
Slide 1: Developing groundbreaking therapeutics for patients with rare and incurable diseases
We are dedicated to developing groundbreaking therapeutics for patients with rare and incurable diseases
Slide 2: Disclaimer
Through our research and development efforts, we aim to provide hope, happiness, and a better life for underprivileged patients by developing treatments. DISCLAIMER No offer or Solicitation regarding Securities This document is for the sole purpose of providing Tiumbio Co., Ltd(“The Company”) inform
Slide 3: Chapter I. Core Competency
Chapter I. Core Competency INVESTOR RELATIONS 2024
Slide 4: TiumBio at a Glance
TiumBio at a Glance Focused on developing breakthrough therapies for rare/incurable diseases Specialized in Successful history of developing Novel drugs discovery system the rare disease area of FDA approved drug AFSTYLA® Discovery Team X 2↑ X 2.9↑
Slide 5: TiumBio's R&D Team Has a Proven Track Record
TiumBio’s R&D Team Has a Proven Track Record “AFSTYLA” List of FDA-approved K-drugs* *Excluding biosimilars and generics 2016.05 2018. 11 Temixys 2014. 06 Innovative hemophilia treatment 2018. 11 Celltrion Sivextro with improved drug durability and Nabota Antiviral Dong-A ST stability with a differe
Slide 6: Experienced Leadership
Experienced Leadership Founder & CEO Jung-hoon Kim Hun-taek Kim In-young Song Joon-sik Moon Head of clinical & Ph.D., MBA Ph.D. (Immunology) M.D. (Medicine) business dev. Career Achievement Jae-won Choi Sun-mi Kim Hae-sung Shin Ph.D. Ph.D. (Immunology) Clinical trial dev. (Medicinal Chemistry) Educa
Slide 7: Discovery Technologies & Systems
Discovery Technologies & Systems TGF-β / VEGF dual inhibitor GnRH antagonist
Slide 8: Remarkable Achievements
Remarkable Achievements Ti Continuous out-licensing deals and R&D collaborations paewon License-Out Pipeline: TU2670 Indication: Endometriosis Partner: Daewon (Korea) Territory: Korea i BeiGene Partnership Pipeline: TU2218 Indication: Solid tumor. Partner: BeiGene (China) Deal: Clinical trial collab
Slide 9: TiumBio's Robust Pipeline
TiumBio’s Robust Pipeline Pipelines indication Discovery 전임상 Phase I Phase II Phase III Partner Endometriosis/ • Ph 2a (Europe, Endometriosis) TU2670 Uterine • Ph 1 (China, Endometriosis) fibroids • Ph 2a (Korea, Uterine fibroids) Clinical TU2218 Solid tumor • Ph 1b (selected as a KDDF* project) • C
Slide 10: Chapter II. Clinical Stage Pipeline
Chapter II. Clinical Stage Pipeline INVESTOR RELATIONS 2024
Slide 11: Merigolix (TU2670) | Unmet Medical Needs
Oral GnRH Antagonist Merigolix (TU2670) | (1) Unmet Medical Needs Endometriosis / Dynamic Changes in the A Game Changer with a New MoA Conventional Treatment Endometriosis Drug Market • Endometrial tissue growth outside the uterus and associated pelvic pain, dyspareunia, and infertility Comparison o
Slide 12: Merigolix (TU2670) | Competitive Edge
Oral GnRH Antagonist Merigolix (TU2670) | (2) Competitive Edge On-Market Competitors Best-in-Class ‘TU2670’ Elagolix Relugolix Hormone control at an appropriate level Regimen 150mg (QD) 200mg (BID) 40mg (QD) through optimal dose selection -4.9% BMD loss (6M) -0.32% -2.61% 120 (GnRH Agonist : -4.4%)
Slide 13: Merigolix (TU2670) | Clinical Study Data
Oral GnRH Antagonist Merigolix (TU2670) | (3) Clinical Study Data Low dose & High efficacy: E2 Suppression↑ Safety Ph 2a Status & Data Release Timeline Source : Company Data Top-line results from the study May-June, 2024 Clinical study report (CSR) August, 2024
Slide 14: Merigolix (TU2670) | Licensing Deal & Indication Expansion Potential
Oral GnRH Antagonist Merigolix (TU2670) | (4) Licensing Deal & Indication Expansion Potential Rising interest in oral GnRH antagonists & Growth potential Relugolix: Sumitomo acquired Myovant for $2.9 B (completed in March, 2023, 100% ownership) Treatment trend Source: Market research reports (Endome
Slide 15: TU2218 | Unmet Needs for Anticancer Drugs
Oral Immuno-oncology therapy TU2218 | (1) Unmet Needs for Anticancer Drugs Immunotherapy (anti-PD-1) Immunotherapy Market Unmet Needs by Cancer Type 26% 74% 담도암 180K • (BTC) 9% 91% • 대장암 390K (CRC) 13% 87% 위암 110K 면역항암제 반응환자 (GC) 면역항암제 불응/비대상환자 *Datamonitor2028 WW incidence report&Globaldata2028 WW
Slide 16: TU2218 | Combination Advantages
Oral Immuno-oncology therapy TU2218 | (2) Combination Advantages TU2218 Dual Inhibitor VEGF TGF-β/R1 TU2218 VEGF/R2 ※ Combination therapies with PD-1/PD-L1 inhibitors FDA-approved novel drug list Chemotherapy VEGF Inhibitor T-cell Activation Targeted Therapy PD-1/PD-L1 Combination partner (Cancer ty
Slide 17: TU2218 | Synergistic Effect with ICIs
Oral Immuno-oncology therapy TU2218 | (3) Synergistic Effect with ICIs TU2218 + Anti PD-1 TU2218 + Anti CTLA4 8000 Vehicle Anti-PD-1 8000 Vehicle Vehicle TU2218 6000 Anti-PD-1 Anti-PD-1 (mm 3)(mm ) 3 TU2218+Anti-PD-1 mAb TU2218 TU2218 6000 TU2218+Anti-PD-1 mAb TU2218+Anti-PD-1 mAb Volume 4000 Volume
Slide 18: TU2218 | Clinical Study Data (Phase 1a)
Oral Immuno-oncology therapy TU2218 | (4) Clinical Study Data (Phase 1a) Pharmacokinetics (PK) of TU2218 Pharmacodynamics (PD) of TU2218 -27.0% -23.7% -41.9% -45.8% -39.7% -47.8% Total(Cohort 1-6) p-value<0.001 (Paired T Test) Dose Starting dose for PD Marker (n=20) Disease No. of Mean change from b
Slide 19: TU2218 | Clinical Development Plan
Oral Immuno-oncology therapy TU2218 | (5) Clinical Development Plan Rationale for Cancer Type 2023 2024 Dose finding / Safety run-in Expansion cohorts / POC study TU2218 + pembrolizumab (Keytruda) Phase 1b Phase 2a Stage 1 Stage 2 BTC cohort STC cohort N**= 22 N***= 40 RP2DC CRC cohort CRC cohort
Slide 20: TU7710 | Unmet Needs in Hemophilia
Hemophilia Treatment Factor VII Fusion Protein TU7710| (1) Unmet Needs in Hemophilia Hemophilia Hemophilia Treatment Market Competition 2.0 2.0 2.0 1.9 2.3 1.8 2.2 2.0 1.5 1.7 7.0 7.5 6.0 6.2 6.5
Slide 21: TU7710 | Competitive Edge
Hemophilia Treatment Factor VII Fusion Protein TU7710| (2) Competitive Edge Longer half-life Improved safety Improved bleeding control (up to 6~7x longer than Novoseven) (Lower immunogenicity than Novoseven) (ng/mL) 106 (ng/mL) G1 TU7710 1.5 mg/kg (n=5) G2 TU7710 3.0 mg/kg (n=5) antigen 105 G3 TU771
Slide 22: TU7710 | Clinical Dev. & Registration Plan
Hemophilia Treatment Factor VII Fusion Protein TU7710| (3) Clinical Dev. & Registration Plan Clinical Program 2023 2024 2025 2026 2027 2028 2029 2030 Korea Hemophilia Phase 1 N = up to 40 / Healthy males, Phase 1a study to evaluate the safety, tolerability, and pharmacokinetics of TU7710 following s
Slide 23: Key Milestones in 2024
Key Milestones in 2024 TU2670 Ph 2a in EU TU2218 Ph1b Combination trial TU7710 Hemophilia Top-line data release Top-line data release Ph1a in Korea Top-line data release TU7710 Hemophilia TU7710 Hemophilia Initiation of Phase 2a Ph1b in EU Ph1b in EU clinical trials IND submission IND approval for T
Slide 24: Chapter III. Value Creation
Chapter III. Value Creation INVESTOR RELATIONS 2024
Slide 25: Value Creation | Protium Science, a TiumBio Company
Value Creation | (1) Protium Science, a TiumBio Company A CDAO company specializing in process development and material characterization Yongho Ahn Chang-Hwan Kim Ick-Hyun Cho CEO Executive VP Executive VP Corporate Operation Process Development Services AnalyticalServices • (Former) Head of CDObusi
Slide 26: Value Creation | SK Plasma
Value Creation | (2) SK Plasma Become a global blood products company and push forward an IPO in 2026 Blood Products Business New NRDO Business (Car-T therapy company, “Synergy area” Pre-IPO equityinvestment)
Slide 27: Value Creation | Long-term Growth Potential
Value Creation | Long-term Growth Potential
Slide 28: Appendix
Appendix Key Information Consolidated Financial Information (4Q23) (in KRW millions) ◆ Foundation: 06 December, 2016 ◆ Listing: 22 November, 2019 (KOSDAQ) ◆ Business area: Novel drug R&D 9,118 57 ◆ Subsidiary: Protium Science, Initium Therapeutics 34,758 32,753 ◆ No. of employees: 54 (R&D: 40, G&A:
Slide 29: Thank You
Thank You IR Contact: ir@tiumbio.com +82 31-600-1530 +82 31-600-1532