Immuneonco Biopharmaceuticals (shanghai) Inc Class H · HKEX:1541
Immuneonco Biopharmaceuticals (shanghai) Inc Class H — Investor Presentation (March 2025)
51 slides from Immuneonco Biopharmaceuticals (shanghai) Inc Class H's investor presentation, March 2025
Slide 1: Corporate Presentation
Corporate Presentation March 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: Table of Contents
Table of Contents Section 1 Company Overview 4 Section 2 Major Oncology Programs 9 Section 3 Non-Oncology Programs 30 Section 4 Financial Highlights 43 Appendix Our Approach 45 3
Slide 4: Company Overview
SECTION 1 Company Overview
Slide 5: Key Milestones
Key Milestones • 30 issued patents • Steady team with 10+ years coordination • 26 pending patent applications • 30 IND approvals from the NMPA and the FDA • 11 ongoing clinical programs 2015-2020 2021 2022 2023 2024 • 2015: ImmuneOnco was IMM01: incorporated in the PRC IMM01: IMM01: IMM2510+ IMM27M
Slide 6: 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 7: 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 8: 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 9: Major Oncology Programs
SECTION 2 Major Oncology Programs
Slide 10: Overview and Competitive Advantage of IMM01 (Timdarpacept)
IMM01(timdarpacept) 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 interac
Slide 11: Phase I Clinical Trial Results of IMM01 Monotherapy
IMM01(timdarpacept) Phase I Clinical Trial Results of IMM01 Monotherapy One of the only two companies to have observed CR in monotherapy clinical trials with a well tolerated safety profile Potent Antitumor Activity and Encouraging Preliminary Clinical Efficacy Response Observed in Patients Treated
Slide 12: Phase I Clinical Trial Results of IMM01 Monotherapy: Safety
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 13: IMM01 + Tislelizumab: Phase II Efficacy in R/R cHL
IMM01 (timdarpacept) + Tislelizumab (PD-1 mAb) Phase II Efficacy in Prior Anti-PD-1 Failed R/R cHL Best Percentage Change from Baseline in Target Lesion Duration of Treatment and Response Best Overall Response R/R cHL Received approval from the NMPA for the protocol of the Phase III clinical n (%) (
Slide 14: IMM01 + Tislelizumab: Superior Efficacy in Anti-PD-1 Failed R/R cHL
IMM01 (timdarpacept) + Tislelizumab (PD-1 mAb) Phase II: Superior Efficacy in Anti-PD-1 Failed R/R cHL Timdarpacept Favezelimab Tifcemalimab (SIRPα-Fc) + (Anti-LAG-3) + (Anti-BTLA) + Tislelizumab (PD-1) Pembrolizumab 1 Toripalimab (PD-1) 2 N 33 34 34 ORR 69.7% 29% 35.3% CR 24.2% 9% 0% Phase III of t
Slide 15: IMM01 + Azacitidine in 1L CMML (Phase II)
IMM01 (timdarpacept) + Azacitidine in 1L CMML ( Phase II ) Best Percent Change from Baseline in the Blast Cells in the Bone Marrow Duration of Treatment and Response Best Overall 1L CMML ≥4 months ≥6 months Response, n (%) (N=22) (N=16) (N=13) 16 14 11 ORR (72.7%) (87.5%) (84.6%) Phase III study of
Slide 16: IMM01 + Azacitidine in 1L CMML: Comparison
IMM01 (timdarpacept) + Azacitidine in 1L CMML Comparison in Treating 1L CMML Response of Major Clinical Studies in CMML 85% • As indicated by the graph, the ORR and CR rates range from ORR CR 37% to 54% and 8% to 18% respectively in major clinical trials of azacitidine in CMML based on historical da
Slide 17: IMM01 + Azacitidine in 1L MDS (Phase II)
IMM01 (timdarpacept) + Azacitidine in 1L MDS (Phase II) Best Percentage Change from Baseline in the Blast Cells in the Bone Marrow (%) Duration of Treatment and Response Best Overall 1L MDS ≥4 months ≥6 months Response (N=51) (N=34) (N=29) Phase III study of IMM01 in combination with azacitidine in
Slide 18: IMM01 + Azacitidine: Comparison of Safety Results
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 19: IMM2510: A bsAb with the mAb-Trap Structure Targeting VEGF and PD-L1
IMM2510 (palverafusp alfa) (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 5 IMM2510 Molecule Structure VEG
Slide 20: IMM2510 Achieved Complete Blockade of Circulating VEGF-A
IMM2510 (palverafusp alfa) (VEGF × PD-L1) IMM2510 at Doses of 3.0 mg/kg or Greater, Achieved Complete Blockade of Circulating VEGF-A PD Analysis Free VEGFA in serum after low Free VEGFA in serum after dosage of IMM2510 treatment high dosage of IMM2510 treatment 400 IMM2510 Low dose 0.007mg/kg (n=1)
Slide 21: IMM2510 Key Competitor Landscape
IMM2510 (palverafusp alfa) (VEGF × PD-L1) Key Competitor Landscape IMM2510 PM8002 AK112 VEGF binding VEGF-A, VEGF-B, PlGF VEGF-A VEGF-A PD-1 or PD-L1 PD-L1 PD-L1 PD-1 ADCC Enhanced ADCC None None VEGR1-D2 PD-L1 IgG1 Fc with Enhanced ADCC 21
Slide 22: IMM2510 Phase Ia: Efficacy Summary in advanced solid tumors
IMM2510 (palverafusp alfa) (VEGF × PD-L1) Phase Ia: Efficacy Summary in advanced solid tumors Duration of Treatment and Response Best Percentage Change from Baseline in Target Lesion • As of Dec 21, 2023 (CSR report date) ORR 12.0% (3 PR), DCR 40.0% (3 PR+7 SD), based on 25 evaluable patients in pha
Slide 23: IMM2510: Global Collaboration Developing One Owned Patent Family
IMM2510 (palverafusp alfa) (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 Bi
Slide 24: IMM2510 Anticipated Catalysts in 2025
IMM2510 (palverafusp alfa) (VEGF × PD-L1) Anticipated Catalysts in 2025 Dec 2024 1H 2025 2H 2025 • Phase Ib/II trial of • Speed up the enrollment of 1L • Initial clinical data from Phase Ib/II trial IMM2510+ NSCLC patients in Phase Ib/II of IMM2510+chemotherapy in 1L chemotherapy in trial of IMM2510
Slide 25: IMM27M (tazlestobart) (CTLA-4 ADCC+)
IMM27M (tazlestobart) (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 t
Slide 26: IMM0306 (amulirafusp alfa) (CD47×CD20)
IMM0306 (amulirafusp alfa) (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 a
Slide 27: IMM0306: First CD47 and CD20 Dual-targeting Bispecific in Clinic
IMM0306 (amulirafusp alfa) (CD47×CD20) 1st CD47 and CD20 Dual-targeting Bispecific to Enter the Clinical Stage Globally Best Percentage Change from Baseline in Target Lesion in Phase Ib Duration of Treatment and Response in Phase Ib IMM0306 + Lenalidomide Phase Ib Developing In-house and Own its IP
Slide 28: 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 29: IMM2520 Preclinical Results and Clinical Development Plan
IMM2520 (CD47×PD-L1) Preclinical Results Market Opportunities and Clinical Development Plan Efficacy Study in Colon Cancer (CT26) Mouse Model (1) Opportunities A huge market potential for IMM2520 ✓ A wide range of cancer indications with high macrophage infiltration Tumor Volume (mm3) ✓ Only about 1
Slide 30: Non-Oncology Programs
SECTION 3 Non-Oncology Programs
Slide 31: IMM0306: Strong Potential in Treating Autoimmune Diseases
IMM0306 (amulirafusp alfa) (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 depletio
Slide 32: IMM0306: Peripheral B Cell Depletion
IMM0306 (amulirafusp alfa) (CD47xCD20/mAb-Trap) Peripheral B cell depletion by IMM0306 was Stronger B cell depletion capacity observed in a wide range of clinical dose than rituximab B cell depletion B cell absolute count cell/l 400 02002-500 g/kg 300 03009-800 g/kg 03010-800 g/kg 200 03011-1200
Slide 33: CD47 contributes to pathogenesis of lupus nephritis
IMM0306 (amulirafusp alfa) (CD47xCD20/mAb-Trap) CD47 contributes to pathogenesis of lupus nephritis Knockout of CD47 reduces IgG levels and improves lupus nephritis CD47 knockout in Faslpr LN disease model resulted in remission of glomerular base membrane thickening and significantly reduced autoant
Slide 34: IMM0306 Potential Global Development Plan
IMM0306 (amulirafusp alfa) (CD47xCD20/mAb-Trap) Potential Global Development Plan 2H2024 2025 2026 2027 PhIb for moderate to severe SLE SLE PhII for moderate to severe SLE US IND expected in 2H 2025 PhIb NMOSD PhIII LN PhII China US 34
Slide 35: Booming Global Business Development of BsAb and TsAb in Autoimmune Field
IMM0306 (amulirafusp alfa) (CD47xCD20/mAb-Trap） 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 Upfront payment of $600 millio
Slide 36: IMM01 Strong Potential in Treating Atherosclerosis
IMM01(timdarpacept) 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 vessel Shrinkage of atherosclerotic plaque was obser
Slide 37: 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/ g 7 2 mg Preclinical Results 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 G ta T+ T+ Compared to Sotatercept, IMC-003 has stronger
Slide 38: IMC-003: Pulmonary Arterial Hypertension Market Potential
IMC-003 (IMM72, ActRIIA/Fc-fusion) Pulmonary Arterial Hypertension (PAH) Market Potential Sotatercept is the only approved drug that can reverse The global PAH market size reached USD 7.3 billion in 2022 disease progression and is expected to hit around USD 12.18 billion by 2032 STELLAR: sotatercept
Slide 39: IMC-010 (IMM7220): GLP-1 and ActRIIA Bispecific
IMC-010 (IMM7220, GLP-1x ActRIIA Fc-fusion protein) A Bispecific molecule Targeting GLP-1 and ActRIIA with Global First-in-Class Potential GLP-1 peptide Activity Engineering ActRIIA (ECD) Binding to 293T-GLP1R Blocking the interaction of ActivinA/ActRIIs on 293T-WT-pCAGA12-EGFP 100 IMC-010 1500 IgG4
Slide 40: 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 41: ActRII biology in reducing fat mass while preserving muscle mass
IMC-010 (IMM7220, GLP-1x ActRIIA Fc-fusion protein) 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 pro
Slide 42: Obesity market and future therapies
IMC-010 (IMM7220, GLP-1x ActRIIA Fc-fusion protein) Obesity market and future therapies • Obesity market was valued at $140.3 billion in 2023 and would reach to $351.8 billion in 2033. • Future therapies required adipose mass reducing but lean mass preserving. Lean mass Future Current Therapies Weig
Slide 43: Financial Highlights
SECTION 4 Financial Highlights
Slide 44: Financial Highlights
Financial Highlights Our cash position increased to 752.1 million mainly due to the cash inflow of Out-licensing (RMB106.9mm) and the Placing (RMB212.3mm) (RMB million) (RMB million) (RMB million) 80 74.1 400 367.6 800 752.1 70 350 700 608.6 60 300 600 50 250 500 40 200 400 30 150 128.0 300 20 100 2
Slide 45: Our Approach
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Slide 46: 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 47: Scientifically and structurally differentiated molecule design based on our drug-by-design 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 48: 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 49: 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 49
Slide 50: 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 51: Thank you!
Thank you!
ImmuneOnco Biopharmaceuticals (Shanghai) — Investor Presentation (March 2025) on 6ix