Voronoi, Inc. · KRX:310210
Voronoi — KIS Korea Investors Conference 2025
45 slides from Voronoi's conference presentation, Feb 17, 2025
Slide 1: IR BOOK
Creating Novel Therapeutics By People With Excellent Expertise In Drug Design IR BOOK February 2025
Slide 2: Disclaimer
Investor Relations 2025 Disclaimer The purpose of this document is to explain the research activities, management planning, and other matters of and pertaining to Voronoi, its affiliates, and related companies (hereinafter collectively referred to as the “Company”), to shareholders, investors, and a
Slide 3: Content
Creating Novel Therapeutics By People With Excellent Expertise In Drug Design CONTENT 1. VRN11. EGFR NSCLC Targeted Therapy 2. ORIC-114(VRN07). EGFR exon20 insertion NSCLC Targeted Therapy 3. VRN10. HER2+ Breast Cancer Targeted Therapy
Slide 4: VORONOI. Overview
Investor Relations 2025 VORONOI. Overview Company Overview Company Structure Establishment Feb 2015 (KOSDAQ IPO in Jun 2022) “Bio –Tech Cluster” Chief Executive Daekwon Kim, Hyuntae Kim Officer Boston SongDo Bldg S 18F, Songdogwahak-ro 32, Yeonsu-gu, Headquarters Incheon, Republic of Korea 21984 Med
Slide 5: VORONOI. Pipeline
Investor Relations 2025 VORONOI. Pipeline Clinical Phase Drug Company Indication Target Pre-clinical Phase 1 Phase 2 Phase 3 EGFR del19/C797S, EGFR L858R/C797S EGFR del19, EGFR L858R (Brainmetastasis) Non-small cell lung cancer VRN11 (NSCLC) EGFR uncommon(2L setting) EGFRdel19, L858R, uncommon EGFR
Slide 6: VORONOI. Milestone Guidance
Investor Relations 2025 VORONOI. Milestone Guidance 2025 1H 2025 2H 2026 1H 2026 2H VRN11 NSCLC Ph.1a/b Ph.2b/3 ASCO, update Ph.1 data AACR, Ph.1 initial data WCLC/ESMO, update Ph.1 data VRN07 NSCLC Ph.1b Ph.2b/3 (ORIC-114) Greater China right partnering Mid-26, Ph.1b initial data(combi-) Mid-25, Up
Slide 7: VRN11 EGFR NSCLC Targeted Therapy
Creating Novel Therapeutics By People With Excellent Expertise In Drug Design VRN11 EGFR NSCLC Targeted Therapy
Slide 8: VRN11. EGFR NSCLC Landscape
Investor Relations 2025 VRN11. EGFR NSCLC Landscape Of Osimertinib resistances, 30~50% are unknown EGFR del19, L858R, C797S mutations and SOC (including EGFR TKIs) refractory/resistant patients VRN11. recruiting heavily pre-treated patients Resistance mechanisms to Osimertinib in EGFR NSCLC1 Primary
Slide 9: VRN11. Potential First/Best-in-class Profile for EGFR NSCLC
Investor Relations 2025 VRN11. Potential First/Best-in-class Profile for EGFR NSCLC 1st Gen 2nd Gen 3rd Gen Gefitinib Afatinib Osimertinib VRN11 Off-target Minimal Off-target demonstrates exquisite selectivity Toxicities Toxicities superiority to competing drugs EGFR Minimal EGFR On-target Highly po
Slide 10: VRN11. Selectivity and Brain Permeability
Investor Relations 2025 VRN11. Selectivity and Brain Permeability ‘Selectivity’ drives better Safety margin “Efficacy↑ Adverse Event↓” High unmet needs for patients with brain metastases“high brain permeability, high marketability” Kinase Selectivity Brain Permeability(Kp,uu,brain/Rat)1 C co. cmpd B
Slide 11: VRN11. in-vivo efficacy
Investor Relations 2025 VRN11. in-vivo efficacy Efficacious in EGFR L858R/C797S as well as EGFR Del19. Also efficacy confirmed in intracranial model Comparison in subcutaneous model of Ba/F3(EGFR LC) Comparison in intracranial model of PC9(EGFR del19) Vehicle Vehicle Erlotinib (50 mpk) QD Osimertini
Slide 12: VRN11. Blood-Brain Barrier Permeability of EGFR Targeting Drugs
Investor Relations 2025 VRN11. Blood-Brain Barrier Permeability of EGFR Targeting Drugs Confirmed higher BBB permeability than other approved treatments VRN11 ph.1 trial includes patients with brain metastasis BBB Permeability of EGFR TKIs (Kp,uu, Brain/ Mouse, Rat)1,2 Phase 1 trial of VRN11 include
Slide 13: VRN11. Ph1 design reflecting superior safety profile
Investor Relations 2025 VRN11. Ph1 design reflecting superior safety profile Superior safety margin compared to Osimertinib, enabling x5-10 folds dose escalation without major AEs. Superior antitumor effect expected from low dose than Osimertinib Ph1 dose escalation plan Safety Margin 5~12 folds +80
Slide 14: VRN11. Phase 1a (Dose escalation) ongoing
Investor Relations 2025 VRN11. Phase 1a(Dose escalation) ongoing Ph1a in progress on SOC resistant/refractory patients Mostly with Del19, L858R mutation or unknown drivers Phase 1a Highlights Dose Escalation, ongoing(up to N ~103) +80mg Key Eligibility 480 mg +80mg ✓ EGFR mutated NSCLC such as Del19
Slide 15: VRN11. Unmet needs for SOC resistant/refractory patients
Investor Relations 2025 VRN11. Unmet needs for SOC (including EGFR TKIs) resistant/refractory patients Lack of efficacy and safety in EGFR TKI resistant/refractory patients make it difficult to explore 1L settings SOC resistant/refractory patient trial indirect comparison EGFR common mutation(2L+) T
Slide 16: VRN11. EGFR NSCLC 1L treatment potentials
Investor Relations 2025 VRN11. EGFR NSCLC 1L treatment potentials EGFR NSCLC 1L treatment potentials 2L to 1L treatment option examples Osimertinib(EGFR) VRN11 1L settings 2L(AURA) 1L(FLAURA) Ph. 1a heavily pretreated pts (2L+) ph.1/2 2013.03~ ph.1/2 2013.03~ enrolling naïve patients Previous treatm
Slide 17: VRN11. EGFR 1L treatment efficacy and safety
Investor Relations 2025 VRN11. EGFR 1L treatment efficacy and safety EGFR common/uncommon mutation NSCLC naïve patients trial indirect comparison Uncommon mutation(1L) Common mutation(1L) Trial LUX-Lung2,3,61,2 KCSG-LU15-093 FLAURA4 MARIPOSA5 Brand name Gilotrif Tagrisso Iressa, Tarceva Tagrisso Tag
Slide 18: VRN11. Comparison of PFS of targeted therapies
Investor Relations 2025 VRN11. Comparison of PFS of targeted therapies Comparison of PFS of targeted therapies(ALK) Comparison of PFS of targeted therapies(EGFR) 1st gen 1st gen 3rd gen ALK Gefitinib 3rd gen Crizotinib Lorlatinib EGFR Erlotinib Osimertinib mPFS 10.9m 60.2m~NR mPFS 9.7m 18.9m BBB per
Slide 19: VRN11. Next planned Steps
Investor Relations 2025 VRN11. Next planned Steps 2025 2026(F) 2027(F) Ph 1b EGFR C797S(+BM) Dose expansion EGFR uncommon(+BM) cohorts EGFR common(+BM) 2L Strategy Ph 2 EGFR C797S, post 1L 3rd TKI Accelerated approval EGFR common, uncommon, 2L cohorts EGFR BM/LM, post 1L 3rd TKI Ph.1a Dose Ph 1b EGF
Slide 20: VRN11. EGFR NSCLC Market size
Investor Relations 2025 VRN11. EGFR NSCLC Market size PFS improvement EGFR NSCLC Market Analysis may grow Each EGFR mutation specific differentiation market additionally Annual EGFR TKI sales EGFR Del19, L858R USD 14.2bn(2032 expected) Uncommon “Best-in-class Drug” PFS 10m+α Exquisite selectivity an
Slide 21: VRN11. ALK vs EGFR
Investor Relations 2025 VRN11. ALK vs EGFR Market Cap 1.1bn USD 6.1bn USD (Jan 31, 2025) Addressable EGFR(~30-40% of NSCLC) ALK(~3-5% of NSCLC) Market 3rd gen, Lorlatinib 4th gen, NVL-655 3rd gen, Osimertinib 4th gen, VRN11* Common(D,L) 18.9m PFS NR(64.3 to NR)1 PFS Uncommon 9.8m2 Compound mutant Co
Slide 22: VRN11 Appendix
VRN11 Appendix
Slide 23: Reinterpretation of IC50 data
Investor Relations 2025 Reinterpretation of IC50 data PK drives antitumor effects Cell viability(%) 100 Pharmacokinetics (PK) and antitumor effect 50 Ctrough,ss,free Drug Log (concentration) Drug concentrations at concentrations IC50 steady state post 24hr Cell viability(%) Efficacy Drug PFS 100 IC5
Slide 24: Simulation of cancer cure rate, PFS (EGFR Del19)
Investor Relations 2025 Simulation of cancer cure rate, PFS(EGFR Del19) Persistercancer cells lead to bypass or acquired resistance mechanism, resulting in shorter mPFS Ctrough/IC50 - Cancer cure rate relationship Ctrough/IC50 - PFS relationship 60 100 Ctrough,ss/IC50 ratio Osimertinib QD 80mg(CNS)
Slide 25: Persister Cancer Cell, Treatment Resistance and PFS
Investor Relations 2025 Persister Cancer Cell, Treatment Resistance and PFS H3255 S.C model H3255 S.C model Simulation of cancer cure rate 800 EGFR L858 CDX SC model H3255 S.C model 100 Monitoring H3255 S.C model Tumor Volume (mm ) Tumor Volume (mm ) Vehicle 3 80 3 H3255 S.C model 800 600 H3255 S.C
Slide 26: Ctrough/IC50-mPFS relationship (EGFR)
Investor Relations 2025 Ctrough/IC50- mPFS relationship (EGFR) NSCLC EGFR case EGFR TKIs PFS(1st line) 70 70 EGFR IC50(nM) 100 Ctrough,ss/IC50 ratio Month X Ctrough,ss,free IC50(nM) 35 35 10 ✓ Target Engagement 1 EGFR Del19 EGFR L858R EGFR 0 0 uncommon Osimertinib Osimertinib Osimertinib VRN11 VRN11
Slide 27: Ctrough/IC50-mPFS relationship (ALK)
Investor Relations 2025 Ctrough/IC50- mPFS relationship (ALK) NSCLC ALK case ALK TKIs PFS(1st line) 70 70 ALK fusion IC50(nM) 100 Ctrough,ss/IC50 X Ctrough,ss,free Month IC50(nM) 10 35 35 ✓ Target Engagement 1 crizotinib brigatinib alectinib lorlatinib 0 0 Crizotinib Brigatinib Alectinib Lorlatinib
Slide 28: ORIC-114 (VRN07) EGFR exon20 insertion NSCLC Targeted Therapy
Creating Novel Therapeutics By People With Excellent Expertise In Drug Design ORIC-114(VRN07) EGFR exon20 insertion NSCLC Targeted Therapy
Slide 29: VRN07 (ORIC-114). aiming 1st/2nd line Approval for EGFR Exon20 Ins. NSCLC
Investor Relations 2025 VRN07(ORIC-114). aiming 1st/2nd line Approval for EGFR Exon20 Ins. NSCLC VRN07(ORIC-114) aiming Second-line Approval for EGFR Exon20 Ins. NSCLC 1 Complete Response(CR) in heavily treated patients 2 2L setting potential for Amivantamab failed/resistant patients 3 Brain activit
Slide 30: VRN07 (ORIC-114). EGFR exon20 inhibitor Competitive Landscape
Investor Relations 2025 VRN07(ORIC-114). EGFR exon20 inhibitor Competitive Landscape ORIC-114 is the only EGFR exon 20 inhibitor to demonstrate a confirmed complete systemic response and confirmed complete CNS response Source: ORIC company overview January 2025 VORONOI _ 30
Slide 31: VRN07 (ORIC-114). First Clinical Evidence of Efficacy in Active Brain Metastasis
Investor Relations 2025 VRN07(ORIC-114). First Clinical Evidence of Efficacy in Patients with Active Brain Metastasis Active brain metastases – Unprecedented among EGFR targeted therapies Limitations of exciting EGFR targeted therapy VRN07(ORIC-114). the first case of CR observed in patient with act
Slide 32: VRN07 (ORIC-114). Molecular Response in NSCLC patients
Investor Relations 2025 VRN07(ORIC-114). Molecular Response in NSCLC patients Ph.1b , ctDNA ORIC-114 achieved >75% molecular depletion in mutant EGFR by week 4 in 67%(18/27) Source: ENA2024 VORONOI _ 32
Slide 33: VRN07 (ORIC-114). First-line Treatment Potential
Investor Relations 2025 VRN07(ORIC-114). First-line Treatment Potential Initiation of expansion cohorts for treatment-naïve patients (2024.04) Clinical Collaboration with Johnson & Johnson(2025.01) • ORIC-114 plus SC amivantamab to be evaluated in 1L NSCLC with EGFR exon 20 Additionally, the company
Slide 34: VRN07 (ORIC-114). Planned Next Steps and Potential Registrational Paths
Investor Relations 2025 VRN07(ORIC-114). Planned Next Steps and Potential Registrational Path(s) in EGFR exon20 insertion NSCLC patients 2025 2026 2027+ 2L NSCLC Strategy Phase 1b • EGFR exon 20 inhibitor-naïve Cohorts • HER2 exon 20 EGFR exon 20, naïve to prior exon 20 Multiple Potential Potential
Slide 35: VRN07 (ORIC-114). EGFR exon20 insertion 1st/2nd treatment
Investor Relations 2025 VRN07(ORIC-114). EGFR exon20 insertion. 1st/ 2nd treatment EGFR exon20 insertion NSCLC trials indirect comparison EGFR exon20 insertion(1L) EGFR exon20 insertion(2L) Trial PAPILLON1 FAVOUR2 CHRYSALIS3 WU-KONG64 FAVOUR2 Brand name Rybrevant+Chemotherapy - Rybrevant - - Amivant
Slide 36: VRN10. HER2+ Breast Cancer Targeted Therapy
Creating Novel Therapeutics By People With Excellent Expertise In Drug Design VRN10. HER2+ Breast Cancer Targeted Therapy
Slide 37: VRN10. HER2 positive Breast Cancer Treatment Guideline
Investor Relations 2025 VRN10. HER2 positive Breast Cancer Treatment Guideline VRN10 to overcome limitations of existing treatment options Trastuzumab+ Tucatinib+ Standard 1L Pertuzumab+ 2L T-dxd(Enhertu) 3L+ Trastuzumab+ of Care Docetaxel Capecitabine mPFS 28.8 months Results of mPFS 18.5 months mP
Slide 38: VRN10. HER2 positive Breast Cancer Treatment Guideline (Expected)
Investor Relations 2025 VRN10. HER2 positive Breast Cancer Treatment Guideline (Expected) 1L SOC Enhertu shifts treatment paradigm Yet VRN10 may be able to address several opportunities Standard 1L T-dxd(Enhertu) 1L+ What is Standard of care after 1st line treatment? of Care Destiny-Breast09 trial U
Slide 39: VRN10. HER2 positive TKI. Competitive Landscape
Investor Relations 2025 VRN10. HER2 positive TKI. Competitive Landscape VRN10 Zongertinib Neratinib ZN-A-1041 Tucatinib HER2 selectivity over EGFR +++ +++ - + +++ Potency to resistant mutants +++ +++ + + Intracranial efficacy +++ - - +++ + Binding mode Covalent Covalent Covalent Non-covalent Non-cov
Slide 40: VRN10. Preclinical in-vitro: Selectivity
Investor Relations 2025 VRN10. Preclinical in-vitro : Selectivity Exquisite selectivity over EGFR(HER1), expecting lower diarrhea and skin rash than approved HER2 drugs Highly selective & potent to HER2 Potent HER2 inhibitor with wider selectivity over EGFR VRN10 S(10)=0.01 Tucatinib VRN10 Neratinib
Slide 41: VRN10. Preclinical in-vivo: Brain metastasis
Investor Relations 2025 VRN10. Preclinical in-vivo: Brain metastasis VRN10, Superior efficacy on HER2 positive intracranial(IC) xenograft model Current SOCs BT474 (HER2+ breast;Tucatinib) BT474 (HER2+ breast; T-dxd) BT474 (HER2+ breast; T+T+C) *TTC group 3/6 mice were dead = 4x of approved dose VRN1
Slide 42: VRN10. Preclinical: GSH reactivity
Investor Relations 2025 VRN10. Preclinical : GSH reactivity Exposed to high chronic tox risk when intaking covalent inhibitor long term as it unwantedly binds to endogeneousdetox substance GSH Albeit covalent inhibitor, VRN10 has low risk of idiopathic chronic tox (i.e. liver tox, heme tox) Less GSH
Slide 43: VRN10. The first-in-human clinical study
Investor Relations 2025 VRN10. The first-in-human clinical study Combination trial to be explored in ph1b Phase 1 clinical trial design (up to N ~72) Ph.1a Dose escalation(Monotherapy) Ph.1b Dose expansion Dose 6 pts Monotherapy Dose 5 pts Dose 4 pts Dose 3 Combination therapy with Antibody drug Dos
Slide 44: VRN10. HER2-positive Breast Cancer Market Landscape
Investor Relations 2025 VRN10. HER2-positive Breast Cancer Market Landscape Trastuzumab+ Tucatinib+ Standard 1L Pertuzumab+ 2L T-dxd(Enhertu) 3L+ Trastuzumab+ of Care Docetaxel Capecitabine Drug name Trastuzumab Pertuzumab T-dxd Tucatinib ZN-A-1041 (Brand name) (Hercepin) (Perjeta) (Enhertu) (Tukysa
Slide 45: Thank You
Creating Novel Therapeutics By People With Excellent Expertise In Drug Design Thank You