Immuneonco Biopharmaceuticals (shanghai) Inc Class H · HKEX:1541
Immuneonco Biopharmaceuticals (shanghai) Inc Class H — H1 2025 Earnings Presentation
57 slides from Immuneonco Biopharmaceuticals (shanghai) Inc Class H's earnings presentation, August 2025
Slide 1: Corporate Presentation
Corporate Presentation August 2025
Slide 2: Disclaimer
Disclaimer THIS DOCUMENT OR THE INFORMATION CONTAINED HEREIN IS NOT INTENDED TO AND DOES NOT CONSTITUTE ANY OFFER OR INVITATION, SOLICITATION, COMMITMENT OR ADVERTISEMENT OF ANY OFFER FOR SUBSCRIPTION, PURHCASE OR SALE OF ANY SECURITIES, NOR SHALL ANY PART OF THIS DOCUMENT FORM THE BASIS OF OR BE RE
Slide 3: H1 2025 Highlights and Upcoming Milestones
H1 2025 Highlights and Upcoming Milestones • ASCO 2025 poster: in combination with AZA in 1L CMML(PhII) and combination with tislelizumab in anti-PD-1 failed R/R cHL(PhII): updating Timdarpacept mPFS to 17.8M and 14.7M respectively Upcoming Milestones （IMM01） • Ph III trials are advancing for 1L CMM
Slide 4: Table of Contents
Table of Contents Section 1 Company Overview 5 Section 2 Major Oncology Programs 10 Section 3 Non-Oncology Programs 32 Appendix Our Approach 49 3
Slide 5: Company Overview
SECTION 1 Company Overview
Slide 6: Key Milestones
Key Milestones • 30 issued patents • Steady team with 10+ years coordination • 31 pending patent applications • 31 IND approvals from the NMPA and the FDA • 12 ongoing clinical programs 2015-2020 2021-2022 2023 2024 2025 • 2015: ImmuneOnco was incorporated in the PRC IMM01: IMM01: IMM2510+ IMM27M in
Slide 7: Integrated proprietary R&D platform
Integrated proprietary R&D platform Efficiently Conduct Screening Optimize Molecule Structure Cost-effectively Manufacture Next-generation Innovative and Druggability Analysis Design High-quality Drug In-house Oncology Therapies Target Selection and High-throughput CMC and IND-enabling Validation Dr
Slide 8: Comprehensive Pipeline Covering Oncology and non-Oncology Therapeutic Areas
Comprehensive Pipeline Covering Oncology and non-Oncology Therapeutic Areas IND/IND- Phase III/ Commercia Program (1) Target (Modality) Indication(s) Discovery Preclinical Phase Ia/I Phase Ib/II Partners Current Status / Upcoming Milestone Enabling Pivotal l Rights IMM01 （timdarpacept） CD47 IMM01 +
Slide 9: Three Strategic Product Matrices Support Future Growth
Three Strategic Product Matrices Support Future Growth We have matured proprietary R&D platform and comprehensive innovation pipeline portfolio • Differentiated molecule design to achieve optimal safety and efficacy balance • Several Phase II study results were selected for oral presentation at ASCO
Slide 10: Major Oncology Programs
SECTION 2 Major Oncology Programs
Slide 11: Overview and Competitive Advantage of IMM01 (Timdarpacept)
Timdarpacept (IMM01) Overview and Competitive Advantage of IMM01(Timdarpacept) In Vivo Efficacy of IMM01 is Dependent on Effective Fc Function (HL-60 xenograft model) IMM01 Full activation of macrophages SIRPα Blocking “Don’t eat me” IMM01 IMM01M domain signal via interrupting CD47 CD47-SIRPα intera
Slide 12: Timdarpacept (IMM01) - Outstanding Ph II Clinical Trial Data
Timdarpacept（IMM01）- Outstanding Ph II Clinical Trial Data • The Phase II clinical data for the three indications listed below are impressive, having gained oral presentations at top international academic conferences • We have received phase III clinical approvals for the three indications in China
Slide 13: Timdarpacept (IMM01) + Azacitidine in 1L HR-MDS (Phase II)
Timdarpacept (IMM01) + Azacitidine in 1L HR-MDS (Phase II) There are two major guidelines recommending the treatment of myelodysplastic syndromes (MDS): 1. The Chinese Guidelines for the Diagnosis and Treatment of Myelodysplastic Syndromes (2019 Edition), formulated by the Chinese Medical Associatio
Slide 14: Timdarpacept (IMM01) + Azacitidine in 1L CMML (Phase II)
Timdarpacept (IMM01) + Azacitidine in 1L CMML ( Phase II ) • The options for treating CMML are very limited, apart from the approval of HMAs for MDS (only a small number of CMML patients have been included in the pivotal studies for MDS). • Over the past 20 years, regulatory agencies have not approv
Slide 15: Timdarpacept (IMM01) + Tislelizumab in Anti-PD-1 Failed R/R cHL
Timdarpacept (IMM01) + Tislelizumab (PD-1 mAb) in Anti-PD-1 Failed R/R cHL (Phase II) • Anti-PD-1 Failed R/R cHL: there is currently no standard treatment available, neither domestically nor internationally, and treatment options are limited. Clinicians rely on chemotherapy based on their experience
Slide 16: Strong Potentials of CD47-based Therapies
Strong Potentials of CD47-based Therapies Timdarpacept holds a leading position globally in the progress of clinical trial for blood tumors and has been approved for combination with IMM2510 in Phase Ib/II clinical trials for solid tumors. The clinical trial is set to commence soon. Global Incidence
Slide 17: Amulirafusp alfa (IMM0306) (CD47×CD20)
Amulirafusp alfa (IMM0306 ) (CD47×CD20) 1st CD47 and CD20 Dual-targeting Bispecific to Enter into the Clinical Stage Globally Overview Mechanism of Action IMM0306 Molecule Structure Full macrophage activation IgG4 CD47 mAb SIRPα-D1 SIRPα “Don’t eat me” blocked “Eat me” signal inactive Improved ADCP
Slide 18: Amulirafusp alfa (IMM0306) in Combination with Lenalidomide
Amulirafusp alfa (IMM0306 ) in Combination with Lenalidomide • The Phase II data of amulirafusp alfa in combination with lenalidomide in relapsed and refractory follicular lymphoma showed excellent CRR and ORR Best Percentage Change from Baseline in Target Lesion in Phase II IMM0306+LEN R/R FL VS R/
Slide 19: Palverafusp alfa (IMM2510) (VEGF × PD-L1)
Palverafusp alfa(IMM2510) (VEGF × PD-L1) A bsAb with the mAb-Trap Structure Targeting VEGF and PD-L1 IMM2510 - Target Introduction and Molecule Structure IMM2510 binds multiple VEGF receptor ligands Avastin binding to various VEGFs IMM2510 binding to various VEGFs 5 IMM2510 Molecule Structure VEGF-A
Slide 20: IMM2510 targets largest market in oncology: NSCLC
Palverafusp alfa(IMM2510) (VEGF × PD-L1) IMM2510 targets largest market in oncology: NSCLC 2024 Sales of PD-(L)1 Inhibitors2 • NSCLC is the largest market opportunity for Keytruda® Keytruda, accounting for ~ 1/3 of sales (pembrolizumab) $4.1B Opdivo® (nivolumab) • PD-(L)1 inhibitors are estimated to
Slide 21: PD-(L)1xVEGF Bispecifics Outperform Pembrolizumab
Palverafusp alfa(IMM2510) (VEGF × PD-L1) PD-(L)1xVEGF Bispecifics Outperform Pembrolizumab Ivonescimab: HARMONi-2 Trial1 BNT327: TNBC Trial2 PFS Time (months) In the Phase III HARMONi-2 trial, ivonescimab showed clinically meaningful improvement over pembrolizumab in BNT327 drove clinical benefit ir
Slide 22: Key Competitor Landscape
Palverafusp alfa(IMM2510) (VEGF × PD-L1) Key Competitor Landscape IMM2510 PM8002 AK112 SSGJ-707 (ImmuneOnco / Instil (BioNTech) (Akeso / Summit) ( 3SBio/ Pfizer） Bio) VEGF-A, VEGF-B, VEGF binding VEGF-A VEGF-A VEGF-A PlGF PD-1 or PD-L1 PD-L1 PD-L1 PD-1 PD-1 ADCC Enhanced ADCC None None None VEGR1-D2
Slide 23: IMM2510 demonstrates cooperative binding to PD-L1 in vitro
Palverafusp alfa(IMM2510) (VEGF × PD-L1) IMM2510 demonstrates cooperative binding to PD-L1 in vitro Presence of VEGF enhances PD-1 Binding of IMM2510 and benchmark antibody to CHO-PDL1 signaling inhibition by IMM2510 and CHO-PD1 cells, respectively, is enhanced with VEGF Bioactivity to block PD-1/PD
Slide 24: IMM2510 + chemo in 1L NSCLC
Palverafusp alfa (IMM2510) (VEGF × PD-L1) + chemo in 1L NSCLC IMM2510 development strategy prioritizes 1L NSCLC • We have reported initial preliminary data recently: the ORR is 62% (13/21); notably, in patients with squamous NSCLC, the ORR reached 80% (8/10). The majority of efficacy evaluable patie
Slide 25: Preliminary Efficacy Data is Comparable to Competitors
Palverafusp alfa (IMM2510) (VEGF × PD-L1) + chemo in 1L NSCLC Preliminary Efficacy Data is Comparable to Competitors Palverafusp alfa (IMM2510)1 lvonescimab2 SSGJ-7073 1L Non-sq 1L squamous 1L Non-sq 1L squamous 1L Non-sq 1L squamous Phase Phase II Phase II Phase II Data publishing July 2025, Compan
Slide 26: IMM2510 Monotherapy efficacy evaluable NSCLC patients
Palverafusp alfa (IMM2510) (VEGF × PD-L1) Monotherapy 13 efficacy evaluable NSCLC patients Late-line, heavily pretreated patients (squamous and non-squamous), data cut off date Dec 24,2024 • 23.1% ORR • 62% of patients with tumor shrinkage TPS: NA • Responses in patients TPS: NA with low (≤ 5%) PD-L
Slide 27: IMM2510 Compares Favorably to Competitor Monotherapy Phase I Datasets
Palverafusp alfa (IMM2510) (VEGF × PD-L1) Monotherapy IMM2510 Compares Favorably to Competitor Monotherapy Phase I Datasets in NSCLC IMM25101 Ivonescimab2 BNT3273 BNT3273 EGFR/ALK/ROS EGFR/ALK Population All-comers EGFR mutant wild-type wild-type Indication NSCLC NSCLC NSCLC NSCLC Dose 3-20 mg/kg Q2
Slide 28: IMM2510 safety comparable to other PD-(L)1xVEGF bispecifics
Palverafusp alfa(IMM2510) (VEGF × PD-L1) Monotherapy IMM2510 safety comparable to other PD-(L)1xVEGF bispecifics BNT327 IMM2510 Ivonescimab Category Phase Ia Phase I3 Phase Ia (n=51)1 (n=80) 2 (n=150) TRAEs 74.5% 77.5% 92.7% TRAEs ≥grade 3 27.5% 22.5% 22.7% Serious TRAEs 5.9% N/R 11.3% TRAEs leading
Slide 29: Global Collaboration Developing One Owned Patent Family
Palverafusp alfa (IMM2510)(VEGF × PD-L1) Global Collaboration Developing One Owned Patent Family 1 issued patent in each of the U.S. and Japan; On August 1, 2024, we reached a license and collaboration agreement 1 issued patent in the PRC with Axion Bio, Inc. (a wholly-owned subsidiary of Instil Bio
Slide 30: Tazlestobart (IMM27M) (CTLA-4 ADCC+)
Tazlestobart (IMM27M)(CTLA-4 ADCC+) A CTLA-4 mAb with Enhanced ADCC Activity IMM27M - Mechanism of Action and Limitations of Approved Stronger In Vivo Antitumor Effects and Preliminary Ph1 data Molecule Efficacy Study in Colon Cancer (MC38) Syngeneic Mouse Model IMM27M Molecule Structure Blocking th
Slide 31: IMM2520 (CD47×PD-L1)
IMM2520 (CD47×PD-L1) Overview Mechanism of Action A CD47 and PD-L1 dual-targeting Full activation of IMM2520 macrophages bispecific molecule for the treatment of SIRPα-D1 solid tumors FcγR CD47 IMM2520 “Don’t eat me” blocked “Eat me” signal activated Anti-PD-L1 Unique structure to avoid RBC binding
Slide 32: Non-Oncology Programs
SECTION 3 Non-Oncology Programs
Slide 33: Amulirafusp alfa (IMM0306) (CD47xCD20/mAb-Trap)
Amulirafusp alfa(IMM0306) (CD47xCD20/mAb-Trap) B-cell depletion was observed in IMM0306 clinical studies, presents a strong potential in the treatments of autoimmune diseases A study conducted by Dr. Georg Schett at the University of Erlangen- Mechanism of Action Nuremberg showed that deep depletion
Slide 34: IMM0306 - Potential in Autoimmune Diseases
Amulirafusp alfa (IMM0306) (CD47xCD20/mAb-Trap)- Potential in Autoimmune Diseases Dual Targeting of CD20 and CD47 Enhances Cell Lineage Coverage, Improving Therapeutic Potential In vitro analysis of SLE patient blood revealed: • CD47: High expression across B-cell subtypes (including plasmablasts),
Slide 35: IMM0306 - Potential in Autoimmune Diseases: IND Approved and Planned
Amulirafusp alfa (IMM0306) (CD47xCD20/mAb-Trap)- Potential in Autoimmune Diseases IND Approved in China IND planned in US & China Systemic lupus Subcutaneous formulation erythematosus (SLE) China: Phase II Phase Ib US: Phase II Neuromyelitis optica Multiple sclerosis (MS) spectrum disorder (NMOSD) C
Slide 36: Global SLE, MS, LN, MG and NMOSD Populations
Amulirafusp alfa (IMM0306) (CD47xCD20/mAb-Trap)- Potential in Autoimmune Diseases Global SLE Population Global MS Population 7.8 Million 1 2.8 Million 2 Global LN Population Global MG Population 2.7 Million 3 1.09 Million 4 Global NMOSD Population 0.17 Million 5 1. Frost & Sullivan, global SLE popul
Slide 37: IMM0306 SLE Phase Ib Trial Design
Amulirafusp alfa(IMM0306) (CD47xCD20/mAb-Trap) SLE Phase Ib Trial Design Screening Primary Treatment Period Extension Treatment Period Follow-up 4W W1-W24 W25-W48 W49-W52 IMM0306 0.8 mg/kg 8 patients DLT observation IMM0306 1.2 mg/kg and SRC 11 patients Phase Ib assessment IMCM0306 1.6 mg/kg Trial b
Slide 38: IMM0306 Shows Rapid, Dose-Dependent SLEDAI-2K Improvement
Amulirafusp alfa (IMM0306) Shows Rapid, Dose-Dependent SLEDAI-2K Improvement Proportion of patients with ≥ 4 points reduction from baseline in SLEDAI-2K score No worsening in PGA scores The percentage of patients with a reduction in SLEDAI-2000 by ≥4 was 87.5% (7/8) in the 1.2 mg/kg cohort Data cut-
Slide 39: IMM0306 - Arthritis, Rash, Alopecia and Vasculitis are Improved
Amulirafusp alfa(IMM0306)- Situation of Arthritis, Rash, Alopecia and Vasculitis are Improved Data cut-off date July 1, 2025. 39
Slide 40: IMM0306 - Sustained B-cell Depletion with Immune Reconstitution
Amulirafusp alfa(IMM0306)- Efficient and Sustained B-cell Depletion with Immune Reconstitution Observed 4 patients showed a trend of immune reconstitution from W12 0.8mg/kg 1.2mg/kg In Patients 5, 6, 8, and 9, B-lineage cells rebounded between Weeks 12 and 24. Notably, the reconstituted B-cell pool
Slide 41: IMM0306 Shows Best-in-disease Potential in SLE
Amulirafusp alfa(IMM0306)- Shows Best-in-disease Potential in SLE Amulirafusp alfa Mosunetuzumab2 Telitacicept3 Belimumab4 (IMM0306) Target CD47xCD20 CD3xCD20 BLyS, APRIL BLyS 87.5% 66.7% 77.8% 46.5% ≥4 points reduction from (7/8) (4/6) (49/63) (127/273) baseline in patients Week4-20 1 Week52 Week48
Slide 42: IMM0306 - Global Deals in the Area
Amulirafusp alfa(IMM0306)(CD47xCD20/mAb-Trap) – Global Deals in the Area Since 2024, the global business development of innovative BsAb and TsAb in the autoimmune field has been booming Product Licenser Licensee Upfront and milestone payment Time Clinical trial progress DR-0201 Dren Bio Sanofi Upfro
Slide 43: Timdarpacept (IMM01) Has Strong Potentials in treating atherosclerosis
Timdarpacept (IMM01) Has Strong Potentials in treating atherosclerosis Our CD47-targeted IMM01 presents a strong potential in treating atherosclerosis CD47 is highly expressed in human atherosclerotic plaque By blocking the CD47 signal, macrophages can phagocytose the atherosclerotic plaque in rat v
Slide 44: IMM01 Animal Study Results in Atherosclerosis
) Timdarpacept (IMM01) – Animal study Results Demonstrated Strong Potential in Treating Atherosclerosis Representative gross pictures of the left common carotid artery Statistically analysis of the results from HE staining (n=5-8/group) Red arrow: hemorrhage site statistically analysis of the result
Slide 45: IMC-003 (IMM72, ActRIIA/Fc-fusion) Preclinical Results
30 RVSP(mmHg) 20 *** *** *** *** *** 10 IMC-003 (IMM72, ActRIIA/Fc-fusion) 0 +V le e 72 3m ) 0m ) ) 1m ) g (1 /kg kg g cl c IM 2-M g/k /k hi hi g/ Preclinical Results g 7 2 mg Ve e 0 al ( ( (1 T -L m C -H pt M or e 7 M M terc M N 2 M G IM IM 1 Compared to Sotatercept, IMC-003 has stronger G ta T+ T+
Slide 46: IMC-011 (IMM91, pro/latent GDF-8 mAb)
IMC-011 (IMM91, pro/latent GDF-8 mAb) IMC-011 shows excellent binding Scholar Rock’s Apitegromab (SRK-015) has demonstrated druggability and blocking activity Binding to latent GDF-8 • SRK-015: A fully human antibody that 2.5 binds to both pro- and latent myostatin 2.0 IMC-011 1.5 Emugrobart/mIgG1 •
Slide 47: Innovative Molecule Matrix Targeting ActRIIA/B
Innovative Molecule Matrix Targeting ActRIIA/B In CB17-SCID mouse model, our candidates showed significant increase in muscle mass after once-weekly administration for 5 weeks Candidate B’s efficacy was superior to competitorX and Candidate A’s efficacy was better than competitorX comparable to bima
Slide 48: MOA of ActRII mAb
MOA of ActRII mAb ActRII biology in reducing fat mass while preserving muscle mass ActRII biology in muscle tissue ActRII biology in adipose tissue Signaling via ActRII receptors inhibits muscle growth and promotes Activin signaling via ActRII receptors directly promotes lipid storage, atrophy. acti
Slide 49: Our Approach
ee DAS FE 46. 0) Ef + Veer al \ rayne LITLE UIC ICO Our Approach
Slide 50: Breaking Drug Resistance and Broaden Benefit
Breaking Drug Resistance and Broaden Benefit Research Has Shown PD-1/PD-L1 Inhibitors Are Only Expected to be Effective in Hot Tumors, Corresponding to its Limited Monotherapy Response Rates, The Activation of Innate Immune Cells is Able to Attract T Cells into Tumor Microenvironment, Turning Cold T
Slide 51: Scientifically and structurally differentiated molecule design based on DbD concept
Scientifically and structurally differentiated molecule design based on our “drug-by-design (DbD)” concept to achieve potent efficacy and favorable safety Mechanism of Action in the CD47-SIRPα Signaling Pathway Guided by the DbD concept, our differentiated molecule design tackles scientific barriers
Slide 52: Overview and Competitive Advantage of IMM01 (Timdarpacept)
Overview and Competitive Advantage of IMM01 (Timdarpacept) Overview Competitive Advantage of IMM01 Monotherapy - Safety Human RBC Binding Analysis of IMM01 350 Mean Fluorescence Intensity Donor Characteristics (n=100) 300 Male (n=62) First SIRPα-Fc fusion protein to enter 250 Female (n=38) the clini
Slide 53: Challenges for CD47-Targeted Drug Development
Challenges for CD47-Targeted Drug Development CD47 Antibody • Target affinity is too high • Severe “antigen-sink” • Much higher clinical dose (30-45mg/kg) • SAEs are inevitable Efficacy Safety 53
Slide 54: Magrolimab Has Very High Target Affinity and RBC Binding Activity
Magrolimab Has Very High Target Affinity and RBC Binding Activity Target affinity assay Without priming dose With priming dose (1mpk, 3mpk) Concerns Magrolimab Receptor Occupancy (RO) IMM01 Receptor Occupancy (RO) Concerns Receptor Occupancy of IMM01 PBMC • Bind to RBC, leading to hemolysis 60 • Too
Slide 55: Phase I Clinical Trial Results of IMM01 Monotherapy
IMM01(timdarpacept) Phase I Clinical Trial Results of IMM01 Monotherapy Safety Results The impact on hemoglobin or platelet is transient and insignificant following the administration of IMM01. HGB Changes Following Single-dose and Cycle 1 by Cohort Majority of TRAE is grade 1 and 2 150 145 50μg/kg
Slide 56: IMM01 (timdarpacept) + Azacitidine: Safety Comparison
IMM01 (timdarpacept) + Azacitidine Comparison: Safety results Magrolimab + AZA vs AZA alone MDS Ib AZA-001 MRCT Magrolimab + AZA (N=95) AZA alone (N=175) TRAE All grades, N(%) ≥Grade 3, N(%) All grades, N(%) ≥Grade 3, N(%) Compared to the trial of AZA alone, significant Anemia 49 (51.6%) 45 (47.4%)
Slide 57: Thank you!
Thank you!
ImmuneOnco Biopharmaceuticals (Shanghai) — H1 2025 Earnings Presentation on 6ix