Adlai Nortye Group Ltd. · NASDAQ:ANL
Adlai Nortye — Investor Presentation (September 2026)
43 slides from Adlai Nortye's investor presentation, September 2026
Slide 1: Corporate Presentation
NASDAQ: ANL Corporate Presentation September 2026 1
Slide 2: Disclaimer
Disclaimer This presentation has been prepared by Adlai Nortye Group Ltd. (the “Company”) for informational purposes only and does not constitute an offer to sell or the solicitation of an offer to buy any securities. This presentation contains forward-looking statements within the meaning of the Pr
Slide 3: A clinical-stage biotechnology company targeting cancer from multiple angles
A clinical-stage biotechnology company targeting cancer from multiple angles 3 Three 2 Two 1 One 1 One Mission. To transform Lead Oncology Innovative Next-Generation deadly cancer into a chronic and Assets. RAS Modalities. IO. eventually curable disease. Advancing first-in-class and potential R&D an
Slide 4: Oncology Therapeutics Clinical Pipeline
Oncology Therapeutics Clinical Pipeline Product MOA Indication Discovery Phase 1a Phase 1b Phase 2 Phase 3 Upcoming Milestone Worldwide Rights pan- RAS-addicted Ph1 dose escalation data AN9025 RAS(ON) Ex-China1 inhibitor tumors readout in 1H27 CEACAM5- CEACAM5 enriched RAS- Ph1 dose escalation data
Slide 5: Multiple Opportunities to Address Large Unmet Need in RAS-Addicted Cancer
Multiple Opportunities to Address Large Unmet Need in RAS-Addicted Cancer RAS Mutations Drive Oncogenic Signaling • Mutations of the RAS gene (KRAS, PDAC NSCLC CRC HRAS, or NRAS) impair normal GTP hydrolysis, favoring the GTP-bound ”on” Pancreatic Ductal Adenocarcinoma Non-Small Cell Lung Carcinoma
Slide 6: AN9025: Oral Small-Molecule Pan-RAS(ON) Inhibitor
AN9025 Oral Small-Molecule Pan-RAS(ON) Inhibitor 6
Slide 7: AN9025: Potential Best-in-Class Pan-RAS(ON) Inhibitor
AN9025: Potential Best-in-Class Pan-RAS(ON) Inhibitor AN9025 was designed by our in-house R&D team to address a broad range of RAS mutations across multiple tumor types Improved in vitro potency Increased in vivo efficacy compared to RMC-6236 compared to RMC-6236 • ≈30x increase in biochemical poten
Slide 8: Higher CypA Binding Affinity & Slower Dissociation
Higher CypA Binding Affinity & Slower Dissociation CypA Kinetic Analysis of Binding to CypA on Octet Binary Affinity AN9025 RMC-6236 AN9025 AN9025 KD1 KD1 = 3.2 nM KD1 (nM) 3.2 12.4 nm Binary Complex ka (1/[M*S]) 1.6 x 105 2.8 x 105 KRAS (GMPPNP-bound) kdis (1/s) 5.0 x 10-4 3.4 x 10-3 RMC-6236 Tri-c
Slide 9: Stronger RAS(ON) Binding Affinity & Slower Dissociation
Stronger RAS(ON) Binding Affinity & Slower Dissociation Kinetic Analysis of Binding to RAS(ON) Mutant AN9025 RMC-6236 (GMPPNP-bound KRASG12D) RAS(ON) Protein KD (nM) ka (1/[M*S]) kdis (1/s) KD (nM) ka (1/[M*S]) kdis (1/s) KRASG12D 8.8 4.9 x 105 4.3 x 10-3 24.8 5.4 x 105 1.3 x 10-2 AN9025 KD2 = 8.8 n
Slide 10: Significantly Higher Potency with Comparable Sensitivity Profile
Significantly Higher Potency with Comparable Sensitivity Profile AN9025 demonstrates ~100-fold more potent inhibition of AN9025 shares a similar RAS mutant sensitivity pattern cell proliferation than RMC-6236 across RAS mutant cell lines as that of RMC-6236 [ i.e. G12X > G13X ≈ Q61X > WT ] IC50 (pM)
Slide 11: Deep Tumor Regression & Sustained Anti-Tumor Effect
Deep Tumor Regression & Sustained Anti-Tumor Effect HPAC model (KRAS-G12D) Vehicle (p.o., QD) AN9025 (0.1 mg/kg, p.o., QD) AN9025 (0.04 mg/kg, p.o., QD) RMC-6236 (25 mg/kg, p.o., QD) RMC-6236 (10 mg/kg, p.o., QD) Days: AN9025 RMC-6236 • AN9025 demonstrated comparable HPAC CTG1 (IC50, nM) 0.056 9.4 a
Slide 12: More Durable RAS Inhibition In Vivo by PK-PD Analysis
More Durable RAS Inhibition In Vivo by PK-PD Analysis PK–PD correlation was evaluated in a HPAC xenograft model after 7 AN9025 RMC-6236 days of continuous oral dosing and compared to PK after the first dose Post-Treatment PK/PD Profile (144~192 hr) 0.04 mg/kg, 0.1 mg/kg, 0.2 mg/kg, 10 mg/kg, 25 mg/k
Slide 13: More Prolonged Anti-Tumor Effect in KP-4 CDX Model
More Prolonged Anti-Tumor Effect in KP-4 CDX Model 2500 Anti-Tumor Tumor volume (mm3) 2000 Effect AN9025 RMC-6236 RMC-9805 1500 1000 Dose (mg/kg) 0.1 0.2 25 100 500 RTV1 (%) on day 0 81.0% 25.7% of best tumor 41.6% 26.6% 120 regression (D14) (D14) Body weight change (%) 110 RTV1 (%) on Day 42 58.2%
Slide 14: Overall Favorable PK Properties
Overall Favorable PK Properties The PK simulation model demonstrated good concordance with observed TK data at Day 28 from 4-week GLP toxicology studies in rats and dogs Mouse Rat Dog Monkey Dose (mpk) 0.25 0.03 0.005 0.1 AN9025 Rat MTD Blood Concentration Profile T1/2 (h) 39 21 49 18 IV Vdss (L/Kg)
Slide 15: Therapeutic Index and Human PK Simulation
Therapeutic Index and Human PK Simulation AN9025 RMC-6236 Human Human Species Mouse Rat Mouse5 Rat5 (60kg)4 (60kg)6 TSC1 (nM) 6.9 8.2 2.45 145 350 88 MED1 Dose 0.0022 1.8 0.030 0.058 8.6 48 (mpk) (0.13mg) (105mg) AUC 167 198 61 3,480 8,400 2,160 (nM*hr) Cmax 9.8 12 2.8 468 1,040 195 (nM) MTD2 Dose 0
Slide 16: Intermittent Dosing Achieves Comparable Tumor Regression
Intermittent Dosing Achieves Comparable Tumor Regression AN9025 demonstrated comparable tumor regression in mouse CDX models with intermittent dosing relative to QD dosing with slightly improved tolerability on intermittent regimen Dose RTV1 BW change2 (mg/kg) (Day 28) (%, Day 28) Vehicle 9.9 (Day 2
Slide 17: Widening of AN9025 Therapeutic Window with Intermittent Dosing
Widening of AN9025 Therapeutic Window with Intermittent Dosing MED1 MTD2 Dosing TSC1 Species Dose Weekly AUC Cmax Dose AUC Cmax TI3 Regimen (nM) (mpk) (nM*hr) (nM) (mpk) (nM*hr) (nM) QD 6.2 0.028 1,050 8.8 0.2 1,390 72 7.3 Mouse BIW 5.8 0.09 983 22 . . . . QW 4.6 0.14 792 34 . . . . 378 QD 7.4 0.053
Slide 18: AN9025 Global Phase I Multi-Regional Clinical Trial in U.S. and China
AN9025 Global Phase I Multi-Regional Clinical Trial in U.S. and China Part 1: Dose-Escalation1 Primary Endpoints Secondary Endpoints AT + mCRM with EWOC • DLTs • PK • DoR Part 1B Intermittent QW Dose-Escalation • Safety • ORR • PFS • Tolerability • DCR Part 1A … Continuous QD Dose-Escalation … 1B5,
Slide 19: Summary of AN9025 Program
Summary of AN9025 Program AN9025’s preclinical profile demonstrates best-in-class attributes among pan-RAS(ON) inhibitors: CypA Binding Affinity: Exhibited ~4-fold stronger binding to Anti-Tumor Effect: Induced deep tumor regression, superior and cyclophilin A (CypA) than daraxonrasib, driven by
Slide 20: AN4035: Novel CEACAM5 Pan-RAS(ON) Inhibitor ADC
AN4035 Novel CEACAM5 Pan-RAS(ON) Inhibitor ADC 20
Slide 21: Addressing the Limitations of Pan-RAS(ON) Inhibitors with ADC Technology
Addressing the Limitations of Pan-RAS(ON) Inhibitors with ADC Technology Limitations of current Pan-RAS(ON) inhibitors due to systemic exposure Skin toxicities GI toxicities Combination limitations Our Solution Deliver pan-RAS inhibition selectively to tumors using antibody-drug conjugate (ADC) tech
Slide 22: RASiCA: Our Proprietary RAS Inhibitor Conjugated Antibody Platform
RASiCATM: Our Proprietary RAS Inhibitor Conjugated Antibody Platform Our RASiCA platform was designed to overcome two major challenges: 1. ADC field: limited diversity of payload classes leading to cross-resistance, which then limits treatment sequencing for ADCs1,2 2. RAS inhibitor field: on-target
Slide 23: RASiCA: Our Proprietary RAS Inhibitor Conjugated Antibodies Platform
RASiCATM: Our Proprietary RAS Inhibitor Conjugated Antibodies Platform Our RASiCA platform was designed to overcome two major challenges: 1. ADC field: limited diversity of payload classes leading to cross-resistance, which then limits treatment sequencing for ADCs1,2 2. RAS inhibitor field: on-targ
Slide 24: Payload Is a Proprietary Highly Potent Pan-RAS(ON) Inhibitor
Payload Is a Proprietary Highly Potent Pan-RAS(ON) Inhibitor Our proprietary payload demonstrated nanomolar cytotoxic Binding Our RMC- potency against various tumor cell lines in vitro Affinity Payload 6236 Payload 72h CTG RAS mutation Indication Cell Line type IC50 (nM) Imax (%) KD1 Binary (CypA) K
Slide 25: Overview of AN4035 Molecular Structure and Stability
Overview of AN4035 Molecular Structure and Stability AN4035 has a stable conjugator Human plasma Compound LC-MS DAR incubation time Day 0 8.04 AN4035 Day 7 7.85 AN4035 has a stable linker-payload Plasma Plasma Payload Release (%) Compound incubation time Human Mouse Rat Monkey Day 0 <0.05 <0.05 0.02
Slide 26: CEACAM5 as a Compelling Target for Pan-RAS(ON) Inhibitor-Based ADC
CEACAM5 as a Compelling Target for Pan-RAS(ON) Inhibitor-Based ADC RAS-Mutant Cancer–Enriched, Skin-Sparing Expression1 Clinically-Validated ADC Target Without Gastrointestinal Dose-Limiting Toxicity • Meaningful efficacy in RASmut-prevalent cancers including NSCLC & CRC • Minimal / manageable on-ta
Slide 27: Superior Target-Mediated Intracellular Payload Retention
Superior Target-Mediated Intracellular Payload Retention ADC drugs Media (10 μg/mL) Cell supernatant conc. Lysis buffer Co-culture 20 min, 2, 4, Cancer Cell 24, 48 h Cell lysate PBS wash payload conc. HPAC cancer cell AN4035 (10 μg/mL) Isotype-payload (10 μg/mL) CEACAM5C (10 μg/mL) Incubation Cell s
Slide 28: Potent Cytotoxicity and Robust Bystander Effect in RAS-Addicted Cancer Cell Models
Potent Cytotoxicity and Robust Bystander Effect in RAS-Addicted Cancer Cell Models AN4035 showed superior bystander killing effect compared to 6-day CTG CEACAM5 TopoI-based ADC CEACAM5 RAS Cancer Cell Line mRNA mutation AN4035 Isotype ADC Type nTPM type SK-CO-1 (CEACAM5 pos) : SW480-Luc (CEACAM5 neg
Slide 29: Robust Anti-Tumor Activity Across CDX Models
Robust Anti-Tumor Activity Across CDX Models HPACKRAS G12D model (PDAC, CEACAM5 mRNA 714) Body weight change (%) CTG1 Single Dose ΔRTV2 Tumor volume (mm3) Compound (IC50, nM) (mg/kg) (%, Day 25) 3 -78% AN4035 0.1 10 -85% AN4035 demonstrated durable tumor regression with a single-dose of 3 mg/kg Days
Slide 30: Enhanced Target-Mediated Tumor Retention, with Improved Tumor Selectivity
Enhanced Target-Mediated Tumor Retention, with Improved Tumor Selectivity Free payload concentrations in tumor, normal tissues and blood after Free payload concentrations in tumor, normal tissues and blood after a a 7-day continuous dosing of the payload alone at 1 mg/kg, PO single dose of AN4035 at
Slide 31: Compelling Anti-Tumor Activity in Single-Mouse PDX Trials
Compelling Anti-Tumor Activity in Single-Mouse PDX Trials AN4035 10mpk QW demonstrated compelling tumor regression in mouse PDX trials1 Indication CR PR SD PD ORR DCR CRC 1 8 2 0 82% 100% PDAC 0 6 0 1 86% 86% NSCLC 3 1 0 4 50% 50% Total 4 15 2 5 73% 81% H-score2 (membrane) H-score2 (cytoplasm) mRNA
Slide 32: Favorable PK and Tolerability in Monkeys
Favorable PK and Tolerability in Monkeys AN4035 showed an antibody-like PK profile, AN4035 achieved high exposure with good tolerability comparable to CEACAM5 mAb in mice1 (no skin or GI toxicities) in monkey1,2 HNSTD has not been reached at 30 mpk C0 AUC T1/2 C0 AUC T1/2 Compound Dose Compound Dose
Slide 33: AN4035 Global Phase I Multi-Regional Clinical Trial in Australia, U.S. and China
AN4035 Global Phase I Multi-Regional Clinical Trial in Australia, U.S. and China Part 1: Dose-Escalation AT + BOIN Part 1B Primary Endpoints Secondary Endpoints AN4035 + Cetuximab • DLT • PK Dose-Escalation • MTD • ORR Part 1A AN4035 Monotherapy • Safety • DCR … Dose-Escalation • Tolerability • PFS
Slide 34: Summary of AN4035 Program
Summary of AN4035 Program AN4035 is a first-in-class CEACAM5-targeting ADC armed with a highly potent pan-RAS(ON) inhibitor payload: Stability & Pharmacokinetics: Favorable thermal and plasma Tumor Regression: Robust anti-tumor activity with deep regression in stability with desirable pharmacoki
Slide 35: AN8025: Potential First-in-Class, Multi-Functional T Cell/APC Modulator
AN8025 Potential First-in-Class, Multi-Functional T Cell/APC Modulator 35
Slide 36: AN8025 Mechanism of Action
AN8025 Mechanism of Action T-cell reactivation Immature APC AN8025 APC activation Immune checkpoint PD-L1 blockade LAG3v Tumor cell Mature APC αPD-L1 “Signal 2” activation PD-1 CD28 CTLA4 CD86v T-cell CTLA-4 blockade AN8025 is a tri-specific antibody that acts as an APC and T-cell Activation modulat
Slide 37: AN8025 Binding and Target Interaction
AN8025 Binding and Target Interaction Biochemical binding of AN8025 to its molecular targets hCTLA4 hCD28 hPD-L1 Samples KD (M) Samples KD (M) Samples KD (M) IgG4 isotype NA IgG4 isotype NA IgG4 isotype NA AN8025 5.63 x 10-9 AN8025 1.02 x 10-8 AN8025 1.86 x 10-9 αPD-L1 NA αPD-L1 NA αPD-L1 1.42 x 10-
Slide 38: AN8025 Induces Superior T-Cell Responses
AN8025 Induces Superior T-Cell Responses AN8025 drives stronger T-cell activation than AN8025 reinvigorates exhausted T cells for efficient tumor cell killing αPD-L1 or αPD-(L)1 combinations Primary T-CHO-PD-L1 assay 1×10 3 Primary T-CHO-PD-L1 assay Exhausted T cells 8×10 2 hIgG4 αPD-L1 Exhausted T
Slide 39: AN8025 Promotes T-Cell Activation in a PD-L1 Dependent Manner
AN8025 Promotes T-Cell Activation in a PD-L1 Dependent Manner AN8025 RKO AN8025+10nM αPD-L1 1.6 H460 Cell line hPD-L1 MFI EC50 (nM) AN8025+100nM αPD-L1 MDA-MB-231 T cell activation(IL2-Luc) 1.5 N87 RKO (PD-L1 high) 40,333 0.08 Enhanced 1.4 LOVO T-cell HEK293 H460 (PD-L1 Med) 24,909 0.202 1.3 activat
Slide 40: AN8025 Enhances Both the Quantity and Functionality of APCs
AN8025 Enhances Both the Quantity and Functionality of APCs APC Quantity1 Human monocytes hIgG4 αPD-L1 AN8025 hLAG3-Fc APC Quality THP1-CCL4 THP1-CD80 1×10 3 hlgG4 hIgG4 THP1-CCL4 THP1-CD80 5×10 3 hlgG4 hIgG4 αPD- L1 αPD-L1 αPD- L1 αPD-L1 AN8025 AN8025 8×10 2 AN8025 AN8025 LAG3-Fc LAG3-Fc 4×10 3 LAG
Slide 41: AN8025 Exhibits Potent Anti-Tumor Activity In Vivo
AN8025 Exhibits Potent Anti-Tumor Activity In Vivo Vehicle αPD-L1 αPDL1+CD86v+LAG3v AN8025 TMV TGI TMV TGI CR Group p-value Group p-value (mm3) (%) (mm3) (%) (%) Vehicle 264 ± 26 Vehicle 987±110 AN8025 187±82 90 40 <0.001 AN8025, 10 mg/kg 58 ± 9 125 <0.001 αPD-L1 401±126 66 10 0.001 AN8025, 2 mg/kg
Slide 42: Favorable PK and Safety Profiles in Non-Human Primates
Favorable PK and Safety Profiles in Non-Human Primates Monkey IL-2 Monkey IL-6 600 1×10 4 100 Monkey IL-2 Monkey IL-6 AN8025 30mpk 80 AN8025 100mpk 400 AN8025 300mpk 60 pg/mL pg/mL 1×10 3 40 ug*mL-1 200 20 0 0 1×10 2 0 6 12 18 24 0 10 20 30 Time (h) Time (h) Monkey TNFα 60 Monkey TNF-a F 300mpk 1×10
Slide 43: Summary of AN8025 Program
Summary of AN8025 Program AN8025 is a potential first-in-class, next-generation cancer immunotherapy with a multi-mechanistic mode of action: T-Cell Activation: Drove robust T-cell activation in a PD-L1– APC Enhancement: Enhanced both the quantity and functional quality of dependent manner. anti
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