Slide 1: 2021 Annual Results Presentation
2021 Annual Results Presentation March 2022 1
Slide 2: Disclaimer
Disclaimer This presentation has been delivered to interested parties for information purposes only and upon the express understanding that such parties will use it only for the purposes set forth above, and it is not intended to form the basis of any investment decision or any decision to purchase
Slide 3: Agenda and presenters
Dr. Michelle Xia Chairwoman,President,CEO =e 2021 Overview Mr.Wenjun Shi MBA,SVP_ Head of Commercialization Cadonilimab Commercialization Preparation Dr. Michelle Xia Chairwoman,President,CEO Clinical Program Updates Mr.Michael Xi MBA, M.S. CFO Financial Highlights ¥. Dr. Michelle Xia Chairwoman,Pre
Slide 4: 2021 Overview
pS N Akesobio 2021 Overview
Slide 5: Who We Are
Who We Are Leading Next-Gen Immuno-Oncology with Supreme Bispecific Antibodies We focus on innovative therapeutic antibodies for Oncology & Immunology, and continue to make progress in the development/commercialization of biological drugs, to defend human health with innovative science. 2012 Founded
Slide 6: Significant Progresses Achieved in 2021
Significant Progresses Achieved in 2021* Marched into commercialization stage with Penpulimab approved and Cadonilimab incoming 1st 4 15 15 20 Commercial BLA/NDA Clinical Late stage Product Submitted Trials Data readout Assets* +: New addition in 2021 Anniko®(Penpulimab) Cadonilimab: 6 in Phase II
Slide 7: Transforming Into Biopharma With Major Products To Market
Transforming Into Biopharma With Major Products To Market 安尼可 ® Anniko (Penpulimab) 开坦尼 ® (Cadonilimab) Sales in 2021 NDA ~RMB212M Approval Aug 2021 Benefited ~17K patients Penpulimab manufactured and shipped from First PD-1 Based BsAb Drug to the Market Zhongshan on Aug 23, 2021 More BLA/NDA Submit
Slide 8: Cadonilimab Commercialization Preparation
yp N Akesobio Cadonilimab Commercialization Preparation
Slide 9: Highly Experienced Commercialization Team
Highly Experienced Commercialization Team 500+ Dedicated Sales Force (and Growing) From Top local Biopharma with Track Records of Success Team members with experiences launching lots of oncology Wenjun Shi drugs, many of which became blockbuster drugs in Oncology MBA/SVP (Commercialization) area 25+
Slide 10: Established Broad and Ubiquitous Coverage and Accessibility
Established Broad and Ubiquitous Coverage and Accessibility Broad and Deep Commercial Footprint throughout China Commmercial Team Headcounts ~800 512 Build Up Multi Level Coverage 37 2020 2021 2022E Collaboration With Distribution Channel and Insurances to Improve Accessibility& Affordability Distri
Slide 11: Leading Bispecific Brand Pioneering the Era of I/O 2.0
Leading Bispecific Brand Pioneering the Era of I/O 2.0 Strong KOL Support and KOL Engagement Paving the Way for a Successful Launch in China Leading Brand Perception with High Quality KOL Engagement 吴小华 教授 中国抗癌协会妇科肿瘤专业委员会主任委员 “PD-1/CTLA-4卡度尼利“高效低毒”的特点将帮助临床实现更多药 物联用可能，突破联用药物数量的“天花板”.” 沈 琳 教授 中国抗癌协会胃癌
Slide 12: Well Prepared for New Product Launch With Comprehensive Commercial Infrastructure
Well Prepared for New Product Launch With Comprehensive Commercial Infrastructure Established Central Market Access Medical Affairs • NDA submitted to NMPA in 2021 • ~100 Post market clinical studies ongoing • NRDL negotiation: pharmaco economics or in planning (IIT,RWS etc.) covering more study on
Slide 13: Huge and Deep Market Potential for Cadonilimab
Huge and Deep Market Potential for Cadonilimab First Mover Advantage and Strong Barrier to Entry Huge Addressable Patient Pool for Backed By Superior Efficacy and Safety Commercialization Submitted NDA to NMPA in Sept 2021 as monotherapy Demonstrated great efficacy for large indications, treatme
Slide 14: World-class GMP Facilities Ready to Support Large Scale Commercialization
World-class GMP Facilities Ready to Support Large Scale Commercialization and R&D Plans Guangzhou Manufacturing Site Zhongshan Manufacturing Site 23,500L In Operation ＞160,000L Total planned capacity 20,000L Stage I in operation 60,000L Stage II & III under construction Guangzhou 40,000L Stage II &
Slide 15: Solid Progress with Clinical Focus to Ensure Continuous Success
Solid Progress with Clinical Focus to Ensure Continuous Success PD1/LAG3 Oncology Focus on developing PD1 / PD1/CD73 FIC or BIC assets with VEGF TIGIT/TGFβ CD73 CD47 targets of huge market Claudin18.2/CD47 TIGIT PD1/CTLA4 potential Ivonescimab Cadonilimab NGF CTLA-4 普特利(PD-1) 安尼可 PD1 Anniko® 30+ inn
Slide 16: Powerful Combo Platform Using Bispecific as Next-Gen I/O Backbone
Powerful Combo Platform Using Bispecific as Next-Gen I/O Backbone Well-positioned to Deliver on Combo TIGIT TIGIT Strategy for Next Generation I/O therapy (AK127) (AK127) • The FIC bsAb Cadonilimab（AK104） and Ivonescimab (AK112) have the potential to become the backbone of future combinational thera
Slide 17: Combo Strategy Targeting Broader Indications with Huge Market Potential
Combo Strategy Targeting Broader Indications with Huge Market Potential & Unmet Medical Needs Expanding our Coverage Potential for Major Cancer Indications Lung Stomach Liver Gynecology(1) Colorectum Breast Thyroid LATE STAGE(2) AK112+Chemo AK104+XELOX AK105+Anlotinib AK104+Chemo AK105+Anlotinib AK1
Slide 18: 1st Product Marketed and More to Expect in the Future
1st Product Marketed and More to Expect in the Future Strong R&D with Clinical Focus and Efficient Execution to Ensure Continuous Success 18 18
Slide 19: Clinical Program Updates
yp N Akesobio Clinical Program Updates
Slide 20: Cadonilimab
Cadonilimab Potential FIC PD-1/ CTLA-4 BsAb NDA submitted to China NMPA in Sep 2021 20
Slide 21: Cadonilimab (AK104, PD-1/CTLA-4) Clinical Development Plan
Cadonilimab (AK104, PD-1/CTLA-4) Clinical Development Plan Progress achieved in 2021 Submitted NDA for 2L/3L cervical cancer under priority review, and currently in final review Started Phase III study of locally advanced cervical cancer and 1L cervical cancer Started Phase III study for 1L GC
Slide 22: AK104 Clinical Efficacy Data (2L/3L r/m Cervical Cancer)
AK104(PD-1/CTLA-4) – Clinical Efficacy Data (2L/3L r/m Cervical Cancer) AK104 demonstrated superior anti-tumor activity in cervical cancer regardless PD-L1 expression in comparison to either PD-1 plus CTLA-4 combo or PD-1 monotherapy 33.0% All comer ORR CR mOS (month) 17.5 25.6% 12.0 12.8 12.0 14.0%
Slide 23: AK104 Preliminary Efficacy Data (Phase II, 1L GC/GEJ)
AK104(PD-1/CTLA-4） – Preliminary Efficacy Data (Phase II, 1L GC/GEJ) AK104 demonstrated superior efficacy and improved OS, regardless of PD-L1 expression status in 1L GC/GEJ 17.4 17.3 mOS (m) mOS 17.3m for all comers, 14.7 13.8 13.1 12.5 11.1-12.3 17.4m for CPS>1 subgroup, compared to 13.8m of Niv
Slide 24: AK104 Clinical Efficacy Data (Phase II, 1L HCC)
AK104(PD-1/CTLA-4) – Clinical Efficacy Data (Phase II, 1L HCC) AK104 in combination with Lenvatinib showed promising efficacy in 1L HCC 6-month OS rate 12-month OS rate 94.1% 83.6% 84.8% 81.0% 67.2% 67.5% AK104+ IMbrave 150 Keynote 524 ORIENT-32** AK104+ IMbrave 150 Keynote 524 ORIENT-32** Lenvatini
Slide 25: Ivonescimab
Ivonescimab Potential FIC PD-1/ VEGF BsAb Leading clinical development progress (Phase III) 25
Slide 26: AK112(PD-1/VEGF) Clinical Development Plan
AK112(PD-1/VEGF) – Clinical Development Plan Progress achieved in 2021 Initiated Phase III trials for NSCLC Initiated combo trials with CD47, Chemo, PARPi, and Cadonilimab for various indications Phase Ia dose escalation data presented at ASCO 2021, 1L EGFRwt NSCLC data presented at CSCO 2021
Slide 27: AK112(PD-1/VEGF) Safety Data Summary
AK112(PD-1/VEGF) – Safety Data Summary Risk of hemorrhage with AK112 declined significantly compared to Bevacizumab AK112±chemo Bevacizumab3 Solid tumors1 Sq-NSCLC2 Preferred Terms Solid tumors Sq-NSCLC (N=342) (N=77) All grades ≥ Grade 3 All grades ≥ Grade 3 All grades ≥ Grade 3 All grades ≥ Grade
Slide 28: AK112 Preliminary Clinical Efficacy Data (mono, PD-L1(+) NSCLC)
AK112(PD-1/VEGF) – Preliminary Clinical Efficacy Data (mono study, Phase II, PD-L1(+) NSCLC) AK112 monotherapy demonstrated potentially superior anti-tumor activities in comparison to Pembrolizumab (SOC) in PD-L1(+) NSCLC PD-L1 TPS≥1% ORR DCR PD-L1 TPS: 1%-49% ORR DCR 100.0% 100.0% 84.6% 65.9% 63.3%
Slide 29: AK112 Preliminary Efficacy Data (EGFR-TKI failed NSCLC)
AK112(PD-1/VEGF) – Preliminary Efficacy Data (Phase II, EGFR-TKI failed NSCLC) Preliminary data of AK112 + chemo combo display promising anti-tumor activities in EGFRm-TKI failed NSCLC ORR: AK112 + Chemo (68.4%) vs Sintili + Beva + Chemo (43.9%) vs Chemo (25.2%) EGFRm-TKI failed NSCLC Phase III stud
Slide 30: AK112 Preliminary Efficacy Data (PD-(L)1 failed NSCLC)
AK112(PD-1/VEGF) – Preliminary Efficacy Data (Phase II, PD-(L)1 failed NSCLC) Preliminary data of AK112 + chemo display promising anti-tumor activities in PD-(L)1 failed NSCLC ORR 40.0% Both non-squamous & squamous NSCLC 23.5% AK112 Pembrolizumab +Docetaxel +Docetaxel (N=20) (N=34) DCR 80.0% 76.5% 1
Slide 31: Ligufalimab
Ligufalimab CD47 Leading clinical development progress (Phase Ib/II) 31
Slide 32: AK117(CD47) Clinical Development Plan
AK117(CD47) – Clinical Development Plan Progress achieved in 2021 AK117+Azacitidine in MDS and AML ongoing Expedite trials of AK117 in combination with AK104±Chemo or AK112±Chemo in adv. solid tumor Confirmatory phase III trial of AK117+Azacitidine in HR MDS is in planning Status Mono / Combo
Slide 33: AK117(CD47) Safety Data
AK117(CD47) – Safety Data As second-generation CD47 antibody，AK117 showed favorably safety profile AK117≥20mg/kg (TEAE) Solid Tumor/Lymphoma Hu5F9≥20mg/kg（TRAE） 20mg/kg 30mg/kg 45mg/kg Total Hemagglutination 41% (12/29) 0 0 0 0 Anemia 66% (19/29) 33%（3/9） 11%（1/9） 11%（1/9） 18% (5/27) Thrombocytopeni
Slide 34: AK117(CD47) Preliminary Efficacy Results
AK117(CD47) – Preliminary Efficacy Results AK117 preliminary data showed encouraging safety and efficacy data in combo therapies Phase Ib/II study in higher-risk MDS and 1L unfit AML As of March 4, 2022, 26 MDS and 34 AML patients have been treated by AK117. SAFETY No DLT reported No TRAE leadin
Slide 35: AK117 Observed PR in Solid Tumors in Combination with Cadonilimab
AK117(CD47) - Observed PR in Solid Tumors in Combination with Cadonilimab Preliminary data in combo therapies showed responses in adv. solid tumors Esophageal adenocarcinoma Pancreatic neuroendocrine tumor Cervical Cancer (with neuroendocrine differentiation, (G 3) (SCC, PD-L1 TPS 20%） Ki67: 80%, PD
Slide 36: Other Products- Clinical Development
Other Products- Clinical Development AK119 AK109 AK127 AK115 Anti-CD73 Anti-VEGFR2 TIGIT NGF • AK119 on healthy • AK109 • AK127 + AK112 • AK115 obtained volunteers (Phase Ia) monotherapy on advanced solid IND approval from completed in 2021 advanced solid tumors IND submitted CDE for the tumors (Pha
Slide 37: Other Products- Clinical Development
Other Products- Clinical Development AK102 AK101 AK111 AK120 Anti-PCSK9 Anti-IL-12/IL-23 Anti-IL-17 Anti-IL-4R Hypercholesterolemia Moderate-to-severe Moderate-to-severe psoriasis Moderate-to-severe atopic • Initiated Phase III trial psoriasis • Completed Phase II patient dermatitis in 2021 • Phase
Slide 38: Financial Highlights
ySN Akesobio Financial Highlights
Slide 39: Sales and Income
Sales and Income Product sales and licensing income RMB mm 340.2 • Product sales: RMB211.6 million related to our newly approved 安尼可 128.6 ® (Penpulimab) starting in late August, 2021, which has brought benefits to around 17,000 patients across the country 211.6 • Licensing fee income: RMB128.6 mill
Slide 40: R&D – Consistently Productive Over The Years
R&D – Consistently Productive Over The Years 1 NDA approved RMB mm 1,123.0 4 NDA/BLA submitted NDA/BLA submitted 1 15 Registration/pivotal trials ongoing Registration/pivotal trials ongoing 9 768.6 Total trials ongoing 27 37 Total trials ongoing IND cleared 13 37 IND cleared Programs advanced into c
Slide 41: 2022 Milestones & Future Catalysts
2022 Milestones & Future Catalysts 41
Slide 42: 2022 Catalysts
2022 Catalysts • Commercialization of Cadonilimab COMMERCIAL • Cadonilimab (PD-1/CTLA-4) approved in 2L/3L cervical cancer & • Penpulimab (PD-1) approved in 1L SQ-NSCLC REGULATORY • Penpulimab (PD-1) approved in 3L NPC Complete patient enrollment for multiple Phase III / Registration trials and poss
Slide 43: 2022 Catalysts (Cont'd)
2022 Catalysts (Cont’d) Advancing the drug candidates into the Phase III / Registration stage • Ligufalimab (CD47) • Pulocimab (VEGFR2) • Gumokimab (IL-17) INNOVATION & CLINICAL Advancing the potentially First-in-class drug candidates into the clinical stage • AK131 (PD-1/CD73) • AK129 (PD-1/LAG-3)
Slide 44: Q&A
PN Akesobio Q&A Contact us: https://www.akesobio.com ir@akesobio.com