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1、I-Mab BiopharmaPioneering the Next-Generation of Immuno-OncologyJanuary 2023|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023DisclaimerThis presentation has been prepared by I-Mab(the“Company”)solely for information purpose.By viewing or accessing the information
2、 contained in this material,you hereby acknowledge andagree that no representations,warranties,or undertakings,express or implied,are made by the Company or any of its directors,shareholders,employees,agents,affiliates,advisors,orrepresentatives as to,and no reliance should be placed upon,the accura
3、cy,fairness,completeness,or correctness of the information or opinions presented or contained in this presentation.None of the Company or any of its directors,shareholders,employees,agents,affiliates,advisors,or representatives accept any responsibility whatsoever(in negligence or otherwise)for anyl
4、oss howsoever arising from any information presented or contained in this presentation or otherwise arising in connection with the presentation.The information presented or contained in thispresentation is subject to change without notice and its accuracy is not guaranteed.This presentation does not
5、 constitute an offer to sell or issue or an invitation or recommendation to purchase or subscribe for any securities of the Company for sale in the United States oranywhere else.No securities of the Company may be sold in the United States without registration with the United States Securities and E
6、xchange Commission(the“SEC”)or an exemptionfrom such registration pursuant to the Securities Act of 1933,as amended(the“Securities Act”)and the rules and regulations thereunder.No part of this presentation shall form the basis of orbe relied upon in connection with any contract or investment decisio
7、n in relation to any securities or otherwise.This presentation does not contain all relevant information relating to theCompany or its securities,particularly with respect to the risks and special considerations involved with an investment in the securities of the Company.Nothing contained in this p
8、resentationshall be relied upon as a promise or representation as to the past or future performance of the Company.Past performance does not guarantee or predict future performance.You acknowledgethat any assessment of the Company that may be made by you will be independent of this presentation and
9、that you will be solely responsible for your own assessment of the market and themarket position of the Company and that you will conduct your own analysis and be solely responsible for forming your own view of the potential future performance of the business of theCompany.Certain statements in this
10、 presentation,and other statements that the Company may make,are forward-looking statements within the meaning of Section 27A of the Securities Act and Section21E of the Securities Exchange Act of 1934,as amended.These statements reflect the Companys intent,beliefs,or current expectations about the
11、future.These statements can be recognizedby the use of words such as“expects,”“plans,”“will,”“estimates,”“projects,”“intends,”“anticipates,”“believes,”“confident,”“soon,”or words of similar meaning.These forward-lookingstatements are not guarantees of future performance and are based on a number of
12、assumptions about the Companys operations and other factors,many of which are beyond the Companyscontrol,and accordingly,actual results may differ materially from these forward-looking statements.The Company or any of its affiliates,advisers,or representatives has no obligation and doesnot undertake
13、 to revise forward-looking statements to reflect future events or circumstances.THE INFORMATION CONTAINED HEREIN IS HIGHLY CONFIDENTIAL AND IS BEING GIVEN SOLELY FOR YOUR INFORMATION AND ONLY FOR YOUR USE IN CONNECTION WITHTHIS PRESENTATION.THE INFORMATION CONTAINED HEREIN MAY NOT BE COPIED,REPRODUC
14、ED,REDISTRIBUTED,OR OTHERWISE DISCLOSED,IN WHOLE OR IN PART,TOANY OTHER PERSON IN ANY MANNER.Any forwarding,distribution,or reproduction of this presentation in whole or in part is unauthorized.By viewing,accessing,or participating in this presentation,you hereby acknowledge and agree to keep the co
15、ntents of this presentation and these materials confidential.You agree not toremove these materials,or any materials provided in connection herewith,from the conference room where such documents are provided.You agree further not to photograph,copy,orotherwise reproduce this presentation in any form
16、 or pass on this presentation to any other person for any purpose,during the presentation or while in the conference room.You must return thispresentation and all other materials provided in connection herewith to the Company upon completion of the presentation.By viewing,accessing,or participating
17、in this presentation,you agreeto be bound by the foregoing limitations.Any failure to comply with these restrictions may constitute a violation of applicable securities laws.2Bringing Transformational Medicines to Patients through InnovationInnovationIntegrityResilienceOUR VALUESOUR MISSION34Company
18、 OverviewPipeline Highlights-5 Value Driver Clinical Assets Investment HighlightsFuture Outlook|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023I-Mabs Remarkable Journey Driven by Innovation and Global Ambition520162018202020222025IPO and listing on NasdaqJumpcan
19、 commercial partnership on eftansomatropin alfaCompany founded2 BLAs expectedAbbVie global partnership on CD47 antibody9clinical assets(5prioritized key assets)10pre-clinical assetsMore BD deals5-6 INDs expectedEstablishment of the US HQSeries A$58 millionSeries B$120 million Series C$227 million$52
20、3 million private placement4clinical assets6pre-clinical assets2017201920212023Expected cash position end of 2022$500M|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023I-Mab:Global Innovative Biotech Company6Maryland-Global HQ Global clinical development Clinical
21、operations in multiple sites across the U.S.San Diego Research center focusing on translational medicineI-Mab Hangzhou GMP manufacturing facility Current Capacity:3 x 2,000LBeijing Clinical operations RegulatoryHong Kong Capital marketLishui GSP companyGuangzhou Clinical operationsShanghai-Global HQ
22、 Global corporate operations Discovery powerhouse Clinical development|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023Global Talents and Leadership761%60%Diverse and Experienced Global TalentsAdvanced Degrees70%Female Employees70%R&D PersonnelGlobal ExperienceIn
23、ternationally renowned oncologist and leading authority in hepatobiliary cancersLed or participated in 50+global oncology clinical trials,incl.KEYNOTE-224,REACH-2,ClarIDHyFormer Professor of Medicine at Harvard Medical School,Director of Liver Cancer Research at Massachusetts General Hospital Cancer
24、 Center,CSO at Jiahui HealthPublished 300+papers in scientific journalsAndrew Zhu,MD,PhDPresident,Acting CEOWeimin Tang,PhDChief Business OfficerWorked at Pfizer,Bristol-Myers Squibb,Sanofi,and Johnson&Johnson15+years of pharma/biotech experience with excellent track record of successful global BDUn
25、ique combination of global and China BD with a deep understanding of each marketplaceFormer acting CEO of Hengrui Therapeutics,the US branch of Hengrui PharmaceuticalsJingwu Zang,MD,PhDFounder,Chairman20+year academic career in Immunology research in US,EU and China with 160+papers in scientific jou
26、rnalsProfessor in Immunology,Baylor College of MedicineUS-licensed physician with extensive clinical trial experienceProfessor and directorship in Chinese Academy of Sciences.Director of Shanghai Institute of ImmunologySenior executive positions at global and China pharma companies,SVP(GSK),Presiden
27、t(Simcere)John Hayslip,MDChief Medical OfficerRichard Yeh,MBAChief Operating Officer,Interim CFOIsaac Meng,MDChief Quality Officer,Head of R&D OperationsClaire Xu,MD,PhDU.S.Site HeadJerry Wang,PhDChief Scientific Officer|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation Januar
28、y 2023Global Innovation and R&D Capabilities8Note:1.Achievements accumulated during their careersDeep Immunology ExpertiseLed by principal scientists with decades of research and drug discovery expertise in pharma R&D and extensive research in immune regulatory pathways200+publications1by in-house e
29、xperts in high-impact journals,incl.Science,Nature Medicine,Nature Immunology,JCI,PNAS,Immunity12 novel drug molecules have advanced into the clinicGlobal Clinical DevelopmentLed by world-renowned oncologists with an excellent track record in developing innovative oncology drugs1,including pembroliz
30、umab,ramucirumab,Ivosidenib,atezolizumab+bevacizumab300+medical science publications1by in-house experts,incl.NEJM,Lancet,JAMA,Lancet Oncology,Journal of Clinical Oncology,Cancer Discovery14 trials conducted in China,8 trials conducted in the US,involving more than 1,000 patients worldwide by I-MabF
31、ull Research and Development CapabilitiesDiscoveryNon-ClinicalTranslational MedicineClinical ResearchClinical OperationsSafety&QAQuantitativeSciencePMOAchievements since 2016:2 assetsfrom Phase 2 to Near-BLA1 in oncology,1 for pediatric indication3 assetsfrom Discovery to End of Phase 22 in oncology
32、,1 for autoimmune indication2 assetsfrom Phase 1 to Phase 21 in oncology,1 for autoimmune indication7 assetsfrom Discovery to Phase 14 in oncology,2 for autoimmune indication and 1 for Alzheimers disease|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023Innovation
33、in 3 Generations“Hot Tumor”“Cold Tumor”1DifferentiatedMonoclonal AntibodiesNovelBi-specific Antibodies4-1BB platformCD3 platform3Tech-Enabled“Super”Antibodies,Immune AdjuvantsPhase 2/3 and Near BLAPhase 1 or IND-Enabling StageTumor targetingImmune activationImmune ActivationProbody for local activat
34、ionmRNA encoded antibodyImmuneAdjuvantAlphabody for cell penetrationPre-clinical Stage29TJ-IA15TJ-IA18IFN|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023First Wave of Differentiated Drug CandidatesDifferentiated Monoclonal Antibodies1Efineptakin AlfaTJ107Plonmar
35、limabTJM2UliledlimabTJD5LemzoparlimabTJC41L MDS Phase 3 trial initiatedSolid tumor in Phase 2Pivotal trial expectedin 2023Phase 2Phase 2Potentially 1stCD47 product in ChinaGlobal frontrunner CD73 antibodyPotentially 1stCD73 antibody in ChinaNovel long-acting recombinant human interleukin-7GM-CSF ant
36、ibodyHematologic malignanciesSolid tumorsNSCLC,SolidtumorsGlioblastoma,TNBC,HNCCRS(COVID-19)DevelopmentPhaseIndicationsProduct Positioning10TJ210Phase 1Novel C5aR antibodySolid TumorsEftansomatropin AlfaTJ101FelzartamabTJ2023L BLA in preparation 2L Phase 3 near completionDifferentiated CD38 Antibody
37、3L MM2L MMPhase 3 completion 2023Differentiated long-acting growth hormonePGHDPrioritized assets|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023MoleculeTumorT CellMacrophageNK CellDifferentiated PropertiesGivastomig(TJ-CD4B)Claudin18.24-1BBGastricPancreaticTJ-L1
38、4BPD-L14-1BBPD-1 resistantTJ-C64BClaudin 64-1BBOvarianTJ-L1IFPD-L1IFNIFNIFNPD-1 resistantTJ-M0021undisclosedComplementary to CD47 therapyTJ-Bs011undisclosedundisclosedundisclosedImmune adjuvantas a combo partner TJ-Bs02undisclosed4-1BBOvarianTJ-Bs03PD-L1undisclosedPD-1 resistantSecond Wave of Next-G
39、eneration Drug MoleculesNovel Bi-specificAntibodies2Hot TumorCold Tumor11Note:1.Novel biologicsValue driver assetPhasePhase 1Phase 1|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023Third Wave Innovative Drugs Enabled by Transformative TechnologiesTech-Enabled“Sup
40、er”AntibodiesImmune Adjuvants3TJ-IA15TJ-IA18IFNProbodymRNA Encoded AntibodyImmune adjuvantas pro-drugAlphabody12mRNA TechnologyIn-body antibody production by encoded mRNAAlphabody TechnologyIntracellular targeting by cell penetrating alphabodyMasking TechnologyTumor conditional activation by pro-ant
41、ibodyArtificial Intelligence TechnologyAntibody discovery accelerated by AI|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023I-Mabs Unique and Proven Value Creation Model From Innovation to Value Creation13R&D EngineInnovationDifferentiated Monoclonal Antibodies1N
42、ovel Bi-specific Antibodies2Tech-Enabled“Super”Antibodies3Competitive advantages in immuno-oncologyInnovation in 3generationsGlobal PartnershipsValue Realization Clinical validation Global out-licensing dealsNew CD47 AntibodiesGlobal DealsExpected potential new partnershipsUliledlimabGivastomig(TJ-C
43、D4B)Commercial Partnerships Fast-to-market in China Maximize commercial valueValue RealizationEftansomatropin AlfaChina MarketExpected potential new partnershipsFelzartamabLemzoparlimab|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023Business Development Capabili
44、ties1Future milestone payments up to$1.295BGlobal PartnershipsCommercial PartnershipsPARTNERSHIPS14$1.5B total deal value15 deals$345M total deal value5 dealsIncl.the landmark deal with AbbVieIncl.the landmark deal with JumpcanUpfront received$200MFuture milestone payments up to$280MUpfront received
45、$35M+Royalties+Shared profits+RoyaltiesNote 1:Refers to the aggregate value for the relevant deals that the Company entered into on a cumulative basis.For details of each relevant deal,please refer to the disclosure filed or furnished by the Company with the SEC.|Pioneering the Next-Generation of Im
46、muno-Oncology|Corporate Presentation January 2023Global Partnerships and Deals15CollaborationIn-licensingCo-developmentOut-licensing|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023Global Achievements and Value Creation to Date1Validated Innovation,Proven Busines
47、s Model,Strong FundamentalsINNOVATION ENGINE3+Years20$1.8BGLOBAL PIPELINEVALUE CREATIONFirst-in-classBest-in-class5-6New INDs3GenerationsNext-gen new assets Expected to enter clinic 2023-2025Differentiated mAbNovel bi-specific BsAbTech-enabled“super”AbFocus on biologics in immuno-oncology9clinical10
48、pre-clinicalInnovative assets5 value driversAs pipeline focus2 BLAsExpected in 2023-2025$1.5B$345MGlobal partnerships169Clinical AssetsCommercial partnershipsUp to$1.59BExpected future milestone paymentsIncl.5 prioritized value drivers2 near-BLAs+2 global frontrunners+1 novel bi-specificBD transacti
49、ons Incl.2 landmark dealsTotal deal valueCash runway$252MPayments received+RoyaltiesNote 1:Refers to the aggregate value for the relevant deals that the Company entered into on a cumulative basis.For details of each relevant deal,please refer to the disclosure filed or furnished by the Company with
50、the SEC.|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023Our Commitment to Environmental,Social,and Governance(ESG)Achieved the Highest Newly-Initiated Rating among China-based Biotech CompaniesA commitment to philanthropic giving which can help build stronger co
51、mmunities.PhilanthropyPeopleCreate a diverse and inclusive culture by promoting gender equity,and supporting employees personal and career development.PatientsDeliver novel products in immuno-oncology to bring transformational medicines to patients through innovation.17|Pioneering the Next-Generatio
52、n of Immuno-Oncology|Corporate Presentation January 2023Leading the Future as a Global Innovator2021 Company of the Year2020 Deal of the Year BioCentury,BayHelix2021 Excellent EmployerT+EmployerTop 10 China Biotech to WatchFiercePharma2020 China Healthcare New Power Top Other Awards50 Smartest Compa
53、nies 2020MIT Technology Review2021 Top 50 Enterprises of Technology PowerTech Power2021 Entrepreneur of the YearEY2020 Best Value Healthcare CompaniesSina Medical2021 Executive of the YearScrip Awards2021 Top 10 Innovative BiologicsChina Health Industry SummitTop 10 Innovative TherapiesSina MedicalC
54、CS Top 50 CompaniesBarrons,Caijing and Tiger SecuritiesTop 10 New IPOThe Hong Kong Institute ofChartered SecretariesTop 50 Listed Company Leaders Global Founders SummitBest Overseas IPO AwardPharmaDJInnovation Top 100E-Healthcare Executive 2020 Future StarsShanghai United Media Group2021 Leading DEI
55、 X Inclusion AwardsHeroTop 10 Immuno-Oncology Startups of 2019GEN2022 Honored CompaniesTop Rankings in 5 CategoriesInstitutional Investor1819Company OverviewPipeline Highlights-5 Value Driver Clinical AssetsFelzartamab-Phase 3,Near BLAEftansomatropin Alfa-Phase 3,Near BLALemzoparlimab-Phase 3Uliledl
56、imab-Pivotal Trial Planned in 2023Givastomig-Phase 1Investment HighlightsFuture Outlook|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023Pre-clinicalFelzartamab3L,2L MM BLA 2023-2025 expectedPotential commercial partnershipEftansomatropin AlfaPGHD BLA 2023-2025 ex
57、pectedActive partnership w/JumpcanLemzoparlimab1L MDS Phase 3 2023Active partnership w/AbbVieUliledlimabNSCLC pivotal 2023 expectedPotential global partnershipGivastomigGastric,pancreatic cancersPotential global partnershipEfineptakin AlfaTNBC Phase 2,CAR-T in discussionPotential commercial partners
58、hipTJ-L14BPD-1 resistant cancersPotential global partnershipTJ-L1IFPD-L1 x IFN-a for PD-1 resistant cancersIND 2023 expectedTJ-C64BClaudin6 x 4-1BB for ovarian cancerIND 2023 expectedTJ-M002Monoclonal antibodyIND 2023 expectedTJ-Bs01Cytokine immune adjuvantIND 2024 expectedTJ-210C5aR mAbPhase 1,Onco
59、logy indicationsNear BLA Phase 1 Phase 2/Phase 3 Prioritized assetsPotential partnerships being exploredPlonmarlimabGM-CSF antibodyCRS Phase 2 in COVID-19TJ-Bs02Bispecific antibodyIND 2024 expectedTJ-Bs03Cytokine immune adjuvant IND 2024 expected205 Prioritized Assets:2Near-BLAs+2Global Frontrunners
60、+1Novel Bispecific21Company OverviewPipeline Highlights-5 Value Driver Clinical Assets Felzartamab-Phase 3,Near BLAA differentiated CD38 antibodyInvestment HighlightsFuture Outlook|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023More Convenient and SaferHighlight
61、s3L MM BLA package readyBind to CD38 overexpressed tumor cells,pathogenic CD38-positive B cells/plasma cells,killing its mediator by inducing antibody-dependent cytotoxicity(ADCC)and antibody-dependent phagocytosis(ADCP)3L MM 2L MM Pipeline AssetsPhase 1Phase 2Phase 3/Near-BLA BLA Commercial Partner
62、shipFelzartamabPotential commercial partnership in ChinaNear-BLABenefits in elderly patients Shorter infusion time(0.5 2 Hours)Lower infusion reaction rate Convenient and good efficacyFelzartamabA Differentiated CD38 Antibody22|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation
63、 January 2023I-Mab HangzhouLocal Manufacturing of I-Mabs AssetsBetter market accessBetter affordabilityHybrid commercialization model to maximize the valueExploring other potential disease areas Current Capacity3 x 2,000LOther Potential Commercial OpportunitiesCommercial CapacityUp to 9 x 6,000L by
64、2024I-Mab Hangzhou refers to I-Mab Biopharma(Hangzhou)Limited,an unconsolidated investee of the CompanyFelzartamabPotentially the First Locally Manufactured CD38 Antibody23|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023Newly diagnosed MM:20,000rrMM patients for
65、 2L/3L:100,000Multiple myeloma as significant unmet needs in China1CD38 MabsStageDaratumumabApprovedFelzartamabPhase 3/Near-BLAIsatuximabPhase 3/Near-BLA 2-3%annual growthPotentially the first locally manufactured CD38 antibodyProduct advantages:shorter infusion time,good safetyPotential benefits in
66、 elderly MM patients60%70%80%90%Diagnostic rate of MM0%20%40%60%Penetration rate of CD38 mabNote:1.Globocan,HLT report,EvaluatePharmaFelzartamabWell Positioned for Rapidly Growing China Market2425Company OverviewPipeline Highlights-5 Value Driver Clinical Assets Eftansomatropin Alfa-Phase 3,Near BLA
67、A differentiated long-acting growth hormoneInvestment HighlightsFuture Outlook|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023RegionAsset Long-Acting TechnologyNo ChemicalModificationPotential Safety AdvantageChinaEftansomatropin alfaHyFcPure Protein FormatChina
68、Jintrolong(GenSci)Chemical linkers PEGChinaPEG-rhGH(ANKEBIO)Chemical linkers PEGChinaACP-011(Visen)Chemical linkers TransConhGHIgD hingeN-terminal CH2 from IgDC-terminal of CH2&entire CH3 from IgG4Advanced Hy-Fc technology Natural long-acting GH protein Proven hyFc long-acting technology Potentially
69、 safer for long term usageEftansomatropin AlfaA Differentiated Long-Acting Growth Hormone26|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023PGHD Pipeline AssetsPhase 1Phase 2Phase 3 BLA Commercial PartnershipEftansomatropin Alfa$35M received$280M expectedRoyaltie
70、s/50:50 profit splitWeekly vs.DailyValidated in a Controlled Trial1Ph 2 Primary Endpoint AchievedNote:1.ESPE Abstracts(2016)86 RFC8.aHV annualized height velocityImproved patient complianceAuto-Injector under developmentWeekly&biweekly sc.injections Eftansomatropin AlfaPhase 3 Data Readout Expected
71、in 202327|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023Rapidly Growing Growth Hormone Market in ChinaChina Growth Hormone MarketShort-acting GHRMB 5.2BRMB 13.2BSource:Frost&Sullivan,CITIC Research11%89%2020RMB 0.6BLong-acting GH203037%63%RMB 22.5B28|Pioneering
72、 the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023Jumpcan-$315M Strategic Commercial Partnership1,700+TertiaryHospitals3,700+Secondary Hospitals18,000Primary&Community Hospitals220ChildrensHospitals600566.SHLeader in ChinaPediatric Medicines3,000+medical representatives and
73、retail specialistsCovering 23,000+hospitals in 30provinces and cities3.4MPGHD patients in China215%-25%Potential Market SharePotential Peak Sales of RMB 3-5B1Product advantagesCommercial advantagesBringing together the innovation of a global biotech and Chinas leading player in pediatric medicinesNo
74、te:1.I-Mab estimates;2.Frost&Sullivan2930Company OverviewPipeline Highlights-5 Value Driver Clinical Assets Lemzoparlimab-Phase 3A highly differentiated CD47 antibodyInvestment Highlights&Expected CatalystsFuture Outlook|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation Januar
75、y 2023Differentiation by DesignUnderlying Mechanism for DifferentiationLemzoparlimab RBC binding(cause for severe anemia)High Anti-tumor Activity024681 01 051 061 071 081 09I g G (1 0 m g/k g)T J C 4 (1 0 m g/k g)5 F 9 (1 0 m g/k g)2 A 1 (1 0 m g/k g)D a y s p o s t t r e a t me n tL u mi n e s c e
76、n c e i n t e n s i t yIgGTJC45F92A1Minimal RBC binding due to glycosylationLowRBCBindingPotent anti-tumor activityLemzoparlimabA Highly Differentiated CD47 Antibody31|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023LemzoparlimabPhase 3 Ready and Potentially the
77、First CD47 Antibody Drug in China1L MDS Ph3 trial approvedAML Solid tumorsPipeline AssetsPhase 1Phase 2Phase 3 BLALemzoparlimabClinical Data Summary DifferentiationNo priming dose requiredPromising anti-tumor activity Less RBC-mediated“sink effect”Compelling safety profileExpected drug safety withou
78、t priming dose regimen based on 200 patients treated so farEncouraging efficacy signals from multiple clinical trials,including in solid tumors,NHL and MDSPositive clinical efficacy was observed in a Phase 2 trial of lemzoparlimab in combination with AZA in 1L HR-MDS32|Pioneering the Next-Generation
79、 of Immuno-Oncology|Corporate Presentation January 2023LemzoparlimabWell-Tolerated Safety Profile without Priming Dose Regimen200+patients treated,including different combinations in solid tumors,NHL,AML,and MDS MTD not reached in any dose regimenMild(grade 1 or 2)TRAE in solid tumor and NHL Good sa
80、fety profile of monotherapy or combination with azacitidine in AML/MDS Source:1.ESMO 2022 poster presentation;2.Du X et al.Efficacy,safety and pharmacokinetics of subcutaneous azacitidine in Chinese patients with higher risk myelodysplastic syndromes:Results from a multicenter,single-arm,open-label
81、phase 2 study.Asia-Pac J Clin Oncol.2018;14(3):270-278Overall Safety Data SummaryPhase 2 Clinical Trial of Lemzoparlimab in Combination with AZA(n=53)Most commonly reported treatment-emergent adverse events(TEAEs)within all grades and in grade 3 were hematological eventsGrade 3/4 anemia was 39.6%.No
82、te:This patient cohort had more severe clinical conditions at baseline.74%of patients had grade 3 anemia,51%had grade 3 thrombocytopenia,and 45%had grade 3 neutropenia at baselineInfusion-related reactions were reported in 5 patients(9.4%);all were grade 1/2TEAEs leading to treatment discontinuation
83、 occurred in 6 patients(11.3%)33|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023LemzoparlimabPreliminary Efficacy Signals Observed in Multiple Clinical Trials 2022 2021 2022202020202020Dose range 1 mg/kg to 30 mg/kg in patients with advanced,refractory solid tum
84、ors1 PR and 3 SD in higher dose cohorts patients who received and failed prior treatments,e.g.nivolumab and ipilimumab Mono-therapy for solid tumors Combo w/rituximab for NHL 7 efficacy evaluable patients(r/r NHL,5 FL,1 DLBCL,1 MCL)who progressed on various previous treatmentsORR 71%,CRR 57%,DCR 100
85、%,median time to initial response 50 days,response duration 61-236 daysCombo w/AZA for MDS Newly diagnosed MDS patients treated with lemzoparlimab(30 mg/kg)plus AZA For patients who began treatments 6 months(n=15),ORR 87%,CRR 40%.For patients who began treatment 4 months(n=29),ORR 86%,CRR 31%Registr
86、ational trial approved by China CDE to start in 2023Combo w/AZA for MDS For patients with TP53 mutation(n=4),ORR 100%,CRR 50%Increased CALR expression in blasts and higher immune infiltrates was probably associated with better clinical response,including patients harboring TP53 mutations3435Company
87、OverviewPipeline Highlights-5 Value Driver Clinical Assets Uliledlimab-Pivotal Trial Planned in 2023A global frontrunner CD73 antibody with best-in-class potentialInvestment HighlightsFuture Outlook|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023UliledlimabA Hig
88、hly Differentiated CD73 Antibody Without the“Hook Effect”RegionCD73 AntibodyNo Hook EffectComplete Enzymatic InhibitionClinical Biomarker StrategyUS/ChinaUliledlimabUS/ChinaOleclumab(AZN)Complete CD73 Inhibition without the“Hook Effect”Unique Intra-Dimer Binding Mode 10-610-410-2100102020406080100An
89、tibody conc.(g/ml)%of enzyme activityComparatorUliledlimabControl36|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023UliledlimabA Global Frontrunner with Best-in-Class PotentialPivotal trial in NSCLC Other solid tumors Pipeline AssetsPhase 1Phase 2Phase 3 BLA Glob
90、al Partnership UliledlimabPotential global partnershipOverall Clinical Data Summary Encouraging Efficacy Observed in Ph 1 Trial1Clinical data based on 150+cancer patients in monotherapy and combination with PD-(L)1 therapyExpected favorable PK/PD profile with no“hook effect”Safe and well tolerated u
91、p to 30 mg/kg.No DLT observedEncouraging efficacy Ph 2 signals in NSCLC patientsClinical response correlated with tumor CD73 expression1 CR&2 PRs(ORR=23%),and 3 SDs(DCR=46%)in 13 efficacy-evaluable patients One CR:PD-(L)1 na ve patient with ovarian cancerTwo PR:Both NSCLC patients,one patient who fa
92、iled nivolumab and the other who had no prior PD-(L)1 treatmentThree SD:Two patients failed PD-(L)1 treatmentNote 1:Data presented at ASCO 202137|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023UliledlimabRobust Response in Patients with CD73highExpression in Pha
93、se 2 Study of NSCLC47patients60 patientsAll patients(n=19)1Patients with CD73high expression(35%)(n=7)Patients with CD73low expression(50%in CD73highNSCLC patients,indicating a correlation between clinical response and CD73highexpression Safe and well tolerated up to 30 mg/kg No DLT observed Encoura
94、ging efficacy signals observed in untreated NSCLC Clinical response correlated with CD73highexpression 7/18 patients(39%)had CD73highexpression19patients38|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023UliledlimabNew Data Readout in 2023,Pivotal Clinical Trial
95、and CDx Development Plans Data readout in 70 NSCLC patients(ORR 1H2023,PFS potentially 2H/2023).Expectto see the same trend of clinical response in CD73highStage IV NSCLC patientsA standardized companion diagnostic kit under development in collaboration with WuXi Diagnostics to be employed in the pi
96、votal clinical trial in 2023Plan to initiate a pivotal trial of uliledlimab in combination with a PD-1 antibody in CD73high Stage IV NSCLC in 2023,using CD73 as a biomarker for patient selection39Ongoing global partnership discussion with the new phase 2 clinical data and clinical development plan 4
97、0Company OverviewPipeline Highlights-5 Value Driver Clinical Assets Givastomig-Phase 1A novel Claudin18.2 x 4-1BB bi-specific antibody for GI cancersInvestment HighlightsFuture Outlook|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023Claudin18.2 as an Effective Tu
98、mor EngagerA Clinically Validated Target for GI Cancers41Selective Tumor ExpressionOn-Target Tissue ExpressionClinical Efficacy vs.SafetyGastric CancerPancreatic CancerEsophagus AdenocarcinomaOnly expressed in stomach and not in other normal tissues40-80%50-80%20-70%|Pioneering the Next-Generation o
99、f Immuno-Oncology|Corporate Presentation January 20234-1BB as an Effective Immune Cell ActivatorIf Systemic/Liver Toxicity Can be Managed 42Good efficacy Dose-dependent liver toxicity(MTD 0.1 mg/kg)Direct cross-linking by FabBinding affinity KD=22 nMPoor efficacy Better safety(no DLT up to 10 mg/kg)
100、Weak cross-linking by FcRBinding affinity KD=69 nMGivastomigStrong potencyGood safetyStrong cross-linking by tumor engagementBinding affinity KD=9.8 nMLocalized immune activation in tumor microenvironmentMinimized systemic toxicity,e.g.liver and immune-related toxicityMinimal Systemic ToxicityStrong
101、 anti-tumor activityPeripheryTumorConditional Activation|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023Differentiated Immunologic Properties of GivastomigClaudin18.2 as a Tumor Engager and 4-1BB as a Conditional T Cell Activator43Molecular DesignKey Target Drug
102、 PropertiesMore potent Claudin18.2 mAb More potent(than zolbetuximab)tumor engager Target broader patient population because it covers tumors of high and low Claudin18.2 expression4-1BB by conditional activation only at tumor site More effective local T cell activation Avoid systemic immune toxicity
103、 and liver toxicity4-1BB scFvClaudin18.2 Potent Claudin18.2 mAb Reduced target mediated toxicity Minimal FcR-mediated 4-1BB clustering Potent intra-tumor 4-1BB agonism CLDN18.2 dependent 4-1BB activation|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023Superior In
104、 Vivo Efficacy of Givastomig44Givastomig showed better efficacy than combo or mono-therapyMice with complete regression were protected against tumor re-challenge,indicating the induction of anti-tumor memory response by givastomig treatmentStrong Tumor Growth Inhibition545760636669727578818405001000
105、1500Tum or Volum e m m3D ays after 1st challengeNaive TG m iceT J-C D 4BT u m o r R e c h a lle n g eLong-lasting Anti-Tumor Response03691215182124273033363942454851010002000300040005000Tum or Volum e m m3D ays after 1st challengehIgGT J-C D 4BC 18.2 m Ab4-1B B m A b(2/7 tum or free)C om bo(1/7 tum
106、or free)Zolbetuximabtu m o r c h a lle n g eB IW *6 d o s e s(6/7 tum or free)Equimolar:mAb 3 mpk;biAb 4 mpkhu4-1BB TG mice(n=7)MC38-huCLDN18.2MC38-huCLDN18.2Re-challengeTIL analysisGivastomigGivastomig|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023Gastric canc
107、er Pancreatic cancerPipeline AssetsPhase 1Phase 2Phase 3/Near-BLA BLA Global PartnershipGivastomigPotential global partnershipGivastomig(Claudin18.2 x 4-1BB)Conditional 4-1BB Agonist with Strong Potency and Reduced Systemic Toxicity45Future Development PlanPhase 1 in the U.S.and ChinaRP2D to be dete
108、rmined based on PK and biomarker dataCLDN18.2 IHC assay for patient selection is developing in parallelPotential to explore development as monotherapy in R/R indicationsPotential global partnership FDA orphan-drug designation Dose-escalation:3 mg/kg to 15 mg/kg(currently at 12 mg/kg)Good drug safety
109、 to date;no DLT observed PR and SD signals observed at 5 mg/kg and 8 mg/kg.The study is ongoing More data and RP2D expected in 2023|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023GivastomigDifferentiated Molecular Design with Early Efficacy Signal 46Robust CMC M
110、anufacturabilityMolecular DifferentiationEncouraging Early Monotherapy Efficacy for Refractory CancerStronger binding affinity across different levels of CLDN18.2 expressionUnique conditional 4-1BB activation for a balanced safety and efficacy advantageLong-lasting immune memory response for superio
111、r anti-tumor activity at tumor siteUS FDA granted Orphan Drug Designation in March 2022Well tolerated without MTD defining toxicities to date,12 and 15 mg/kg enrollingPR and SD signals observed in givastomig monotherapy across different dose levelsRP2D to be determined based on PK and biomarker data
112、CLDN18.2 IHC assay for patient selection is developing in parallelPotential to explore development as monotherapy in R/R indicationsA stable cell line with a good titerRobust CMC process developed and scaled up to 500L,3 batches completed47Company OverviewPipeline Highlights-5 Value Driver Clinical
113、Assets Investment HighlightsFuture Outlook|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023Investment Highlights48ValidatedInnovationInnovativePipelineLandmarkBD DealsStrong CashPositionInnovative pipeline with FIC and BIC potentialEarly-stage assets for global p
114、artnerships Late-stage assets for China commercial partnershipsPartnership deal value$1.8BPayments received$252M2Near-term BLAsfelzatamab&eftansomatropin alfa2Global frontrunners in Ph 2/3 lemzoparlimab&uliledlimab4newcomers:Givastomig&TJ-L14Bin Ph 1,2new INDs in 2023CD47 partnership with AbbVie$200
115、M+$1.295B+royaltiesEftansomatropin alfa partnership with Jumpcan$35M+$280M+royalties/shared profitsExpected end of 2022 cash on hand$500MCash runway extending beyond 3yearsPotential new deals:uliledlimab,givastomig,felzartamab,lemzoparlimabPotential new deals+cash flow from existing deals|Pioneering
116、 the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023Ph 1&INDPh 3 ReadyPivotal in 2023Near BLAFelzartamab&EftansomatropPhase 3 data readout Eftansomatropin alfa in 2H2023Felzartamab end 2023Potential commercial partnership for Felzartamab49Expected Catalysts in 2023 Lemzoparlim
117、abUliledlimabFelzartamab&EftansomatropinAlfaLemzoparlimabGivastomig&NewcomersPhase 3 trial 1L HR-MDS trial to be initiatedParallel clinical trials ongoingPotential commercial partnership Phase 2 data readout Uliledlimab/ToripalimabNSCLC Ph 2 positive data update in 2H2023Pivotal trialUliledlimab/PD-
118、1 mAb in CD73highStage IV NSCLC in 2023Potential global partnership Phase 1 data readout Givastomig GC Phase 1 data update(PR and SD observed)Potential global partnership for GivastomigTwo new INDs in 2023|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023Strong Fi
119、nancial PositionCash Runway Extending Beyond 3 years50Strong Cash PositionExpected cash position at the end of 2022$500MEstimated cash runway to fund key business operations for more than three yearsReducing Burn RateIncreasing Cash InflowCommitted to operational efficiencies with well-controlled bu
120、dgetTarget cash burn rate$120M in 2023Expected milestone payments from the existing partnership dealsPotential income from new BD deals|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023Strengthened Fundamentals:2022 vs.2020Advanced Pipeline,More BD Deals and Reven
121、ue,Strong Cash PositionNote:1.Market cap after IPO vs.as of 12/30/22;Cash position after IPO in 2020 vs.Expected cash position at end of 2022 51BD Partnership Value($MM)120 1,930 After IPO in 2020End of 202253233After IPO in 20202022Maturing Clinical Pipeline79Ph 3Ph 2Ph 1Market Cap vs.Cash Position
122、1($MM)800350290500After IPO in 20202022Market CapCash Position|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023Felzartamab,Ph 3 on track;BLA submission expectedEftansomatropin alfa,Ph 3 data readout 2023,BLA submission expectedLemzoparlimab,Ph 3 for 1L MDS,parall
123、el studies Uliledlimab,Ph 2 data readout expected in 2023Givastomig,Ph 1 data readout with PR and SD,Ph 2 expected in 2023Focusing on 5 value driver assetsPCAOB issues resolvedand de-listing risk mitigated(auditor switch to be activated if necessary)Corporate restructuring plan for further mitigatio
124、n of geopolitical risksMitigating risks that impacted I-Mabs mkt capOptimized workforce Streamlined business model and projectsSignificantly reduced cash burn rate in 2022 with more reduction in 2023Potential new partnership dealsRe-positioning and extending cash runway 52Prioritizing Pipeline,Mitig
125、ating Risks&Extending Cash RunwayRe-positioned in 2022 to Deliver Critical Value,Mitigate Risks and Preserve Cash|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023Risks&Negative Impact Largely Mitigated2023 Presents a Significant Opportunity for Investors53Geopoli
126、tical&ADR de-listing risksCOVID-Zero policy in ChinaInterest rate hikes in the U.S.Safety concerns on CD47 target 1234PCAOB issue resolved-complete access to audit firms in ChinaChina shifted to reopening and more friendly policies expectedCapital markets are regaining confidence in undervalued grow
127、th stocksMagrolimab trial suspensions liftedLemzoparlimab positive Ph 2 safety and efficacy data.Ph 3 trial approvedEfficacy of CD73 antibody as a drug class 5Reported new uliledlimab Ph 2 data-robust clinical response rate in CD73highStage IV NSCLC patients54Company OverviewPipeline Highlights-5 Va
128、lue Driver Clinical Assets Investment HighlightsFuture Outlook|Pioneering the Next-Generation of Immuno-Oncology|Corporate Presentation January 2023Commercial PartnershipsGlobal PartnershipsNext Wave of Pipeline AssetsBi-specific antibodiesImmune AdjuvantsOther novel molecules2-3 FelzartamabEftansom
129、atropin Alfa3L,2L MM BLAPGHD BLA(Jumpcan partnership)LemzoparlimabUliledlimabGivastomig1L MDS Ph 3 2023New CD47 mab progressing(AbbVie)Ph 2 data readout and pivotal 2023RP2D andPh 2 2023PoC or Ph 3 expected2 BLAs expected5-6 New INDs or Ph 1 expectedContinued and Focused Value Creation 2023-2025Potential New Deals2 Potential Deals2 Potential Deals55IMabBiopharmai-mab56BeijingSan DiegoMaryland(Global HQ)I-Mab HangzhouHong KongShanghai(Global HQ)LishuiGuangzhouBringing Transformational Medicines to Patients Through Innovation