Slide 1: 2024 Interim Akeso Corporate Presentation
2024 Interim Akeso Corporate Presentation 2024.08
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: Business Highlights
Akesobio Business Highlights OGRA?
Slide 4: Highlights of Akeso Pipeline Development Progress in 2024 H1
Highlights of Akeso Pipeline Development Progress in 2024 H1 1 blockbuster New Drug Marketing Authorization Ivonescimab (PD -1/VEGF) EGFR TKI progressor nsq-NSCLC Applications ( NDA ) approved by CDE 1 Penpulimab new Supplemental Indication Applications ( sNDA ) 3L Nasopharyngeal carcinoma for M
Slide 5: Two First-in-Class bispecific antibodies driving commercial growth
Two First-in-Class bispecific antibodies (cadonilimab and ivonescimab) driving commercial growth In 1H 2024, total product revenue of Akeso were ~ $132 million USD (RMB 939 million), +24 % over the same period last year The growth is mainly due to the marketing approval and sales growth of the compa
Slide 6: Cadonilimab included in 13 clinical treatment guidelines
Cadonilimab included in 13 clinical treatment guidelines, covering multiple indications • First recommendation in CSCO Cervical Cancer Guidelines (2022)(2023) • For recurrent and metastatic cervical cancer, the only recommendation of the National Health and Medical Commission's Guidelines for the Cl
Slide 7: Ivonescimab approved: reshaping the lung cancer treatment landscape
Ivonescimab approved: reshaping the lung cancer treatment landscape and efficiently achieving commercialization World First, Landscape Reshaping 5 Guidelines Recommendation + Expert Consensus Included in the first category recommendation of the Chinese Guidelines for the ‘Immunotherapy+ Anti-angio
Slide 8: Cadonilimab achieving success in first-line Cervical Cancer and expanding indications
Cadonilimab achieving success in first-line Cervical Cancer, and expanding into multiple additional indications Next generation IO cornerstone therapy: broad-spectrum, high-efficacy, low-toxicity, and differentiated Significant market opportunities and benefiting large patient populations … 23+ clin
Slide 9: Cadonilimab addressing unmet need in first-line Gastric Cancer
Cadonilimab addressing critical unmet need in first-line Gastric Cancer treatment Significant efficacy in the all comers and PD-L1 low-expression and negative population AK104-302(COMPASSION-15) AK104-201(COMPASSION-04) invited as one of the four official AACR press conference themes published in to
Slide 10: Cadonilimab addressing unmet need in first-line Cervical Cancer
Cadonilimab addressing critical unmet need in first-line Cervical Cancer treatment Significant efficacy in the entire population and PD-L1 low-expression and negative population AK104-303 (COMPASSION-16 ) 1L cervival cancer obtained strong positive results (AK104-303/Compassion-16) “Cadonilimab has
Slide 11: Ivonescimab achieves success in lung cancer and expands globally
Ivonescimab achieves success in lung cancer and expands in both Chinese and Global Markets New generation of IO cornerstone drugs: broad-spectrum, high-efficacy, low-toxicity, and differentiated Expand and enhance lung cancer markets, expand into additional tumor types, and upgrade existing SoC Cond
Slide 12: AK112-301 data released in ASCO for TKI-resistant patients
AK112-301 data released in ASCO, bringing new treatment options for TKI- resistant patients Top international medical journals Rated by OncoAlert as Published in JAMA (Journal of the American 2024 ASCO Lung Cancer Medical Association) Top 10 Impact Factor 120.7 Professor Zhang Li 2024 ASCO Oral Pres
Slide 13: World's first Ph III study showing superiority over Keytruda monotherapy
The world's first Ph III study showing superiority over Keytruda monotherapy - a better chemo-free option for 1L lung cancer patients AK112-303 obtained a decisive victory over Keytruda (AK112-303/HARMONi-2) Gaining wide attention from global media Ivonescimab vs Pembrolizumab First-line treatment f
Slide 14: Two I/O bispecifics as cornerstone therapeutics creating multiple combo options
Two I/O bispecifics as cornerstone therapeutics, creating multiple combo options to treat a large number of tumor indications Two-pronged approach, advancing in parallel Continuous and productive internal innovation + extensive external collabration Accelerate internal innovation and combination • A
Slide 15: Ligufalimab (CD47) enters Phase III registrational trial
Ligufalimab (CD47) enters Phase III registrational trial, advancing globally for hematological tumors and solid tumors simultaneously Expanding addressable tumor types by creating combination therapies with bispecific backbones Solid tumors: The world's first Phase III Hematological tumors: Global m
Slide 16: Pulocimab (VEGFR2) enters Phase III registration trial
Pulocimab (VEGFR2) enters Phase III registration trial, combined with cadonilimab, developing in large IO-resistant indication Expanding addressable tumor types by creating combination therapies with bispecific backbones AK109 + AK104 + chemotherapy 2L gastric cancer that progressed on IO therapy Th
Slide 17: Ebdarokimab and Ebronucimab NDA under final review
Ebdarokimab and Ebronucimab NDA under final review Ebdarokimab (AK101, IL-12/IL- Ebronucimab (AK102, PCSK9) 23) NDA under final review NDA under final review Submitted in Aug. 2023 Submitted in Jun. 2023 Indications: Indication: • Primary hypercholesterolemia and mixed Moderate to severe plaque psor
Slide 18: Gumokimab Phase III reached endpoints, Manfidokimab Phase III underway
Gumokimab (IL-17) pivotal Phase III trial reached endpoints, Manfidokimab (IL-4Rα) pivotal Phase III trial is underway Gumokimab (AK111, IL-17) Manfidokimab (AK120, IL-4Rα) Psoriasis Focusing on clinical needs and complementing the advantages of Ebdarokimab Atopic dermatitis • The pivotal Phase III
Slide 19: Deep pipeline of potential First-in-Class and Best-in-Class products
Deep pipeline of potential First-in-Class and Best-in-Class in- house developed products pipeline Oncology Trispecific ILT2/IL HER-3 PD-1/VEGF 4 T4/CSF CD47 Antibody 1R ADC marketed products Claudin TIGIT/ 18.2/ CD73 CD47 TGF-β Ligufalimab Bispecific PD-1/CTLA-4 ADC-2 ADC-2 Drebuxelimab IL- PD-1/ VE
Slide 20: Expand collaboration with SUMMIT to accelerate development and commercialization
Expand collaboration with SUMMIT to accelerate development, registration and commercialization in various regions around the world On June 3rd 2024 , Akeso and SUMMIT signed an amended license agreement to expand the licensed territory of ivonescimab • Akeso will receive an upfront and milestone pay
Slide 21: Core Product Clinical Progress
Core Product Clinical Progress
Slide 22: Cadonilimab's major readout, R&D progress, regulatory affairs and milestones
Cadonilimab’s major readout, R&D progress, regulatory affairs and milestones AK104-201 1L GC, PhII AK104-216 COMPASSION-15/ AK104-303 AK109-201 1L CC, PhIII Intermediate HCC, PhII AK104-302 PD-(L)1 resistant GC, PhII 1L GC, PhIII Data Readout Q1 2024 Q2 2024 Q3 2024 Q4 2024 R&D, FPI AK104-307 1L PD-
Slide 23: COMPASSION-15: cadonilimab + XELOX 1L G/GEJ
Cadonilimab (COMPASSION-15) potential new treatment in Gastric Cancers COMPASSION-15: cadonilimab +XELOX 1L G/GEJ （N=610） Brings safer and more efficacious IO therapy to Reshape a New Pattern of All comers of GC Treatment of 1L GC (regardless of PD-L1 expression/status) Significant survival benefit
Slide 24: COMPASSION-15 primary endpoint: OS results
COMPASSION-15 primary endpoint: OS results showed cadonilimab + chemo decreased death risk by 38% vs chemo risk of death risk of risk of decreased death death 38% decreased decreased 44% 30% • Cadonilimab plus chemo group demonstrates long-term survival benefits: 12-month OS rate of cadonilimab plus
Slide 25: Historic data: No OS benefit observed with PD-L1 negative or low expression
Historic data: No OS benefit observed with PD-L1 negative (CPS<1) or low expression (CPS<5) in CM649 and KN859 trials OS subgroup analysis by PD-L1 CPS in KN859 OS subgroup analysis by PD-L1 CPS in CM 649 25 Lancet. 2021;398(10294):27-40.; 2023ESMO VP1-2023.
Slide 26: Cadonilimab reached primary endpoints in all comers in 1L Cervical Cancer
Cadonilimab reached primary endpoints and demonstrated significant survival benefits in all comers in 1L Cervical Cancer AK104-303 (COMPASSION-16）1L CC statistically significant results (AK104-303/Compassion-16) Among ITT population, cadonilimab reached primary endpoints of cadonilimab+chemo±bev v
Slide 27: Ivonescimab's major readout, R&D progress, regulatory affairs and milestones
Ivonescimab’s major readout, R&D progress, regulatory affairs and milestones AK112-206 CRC AK112-201sqNSCLC AK112-301 / HARMONi-A AK112-303 / HARMONi-2 AK117-203 TNBC AK112-201&202 NSCLC AK112-205 NSCLC AK117-202 BTC with brain metastasis AK117-201 HNSCC neoadjuvant Data Readout Q1 2024 Q2 2024 Q3 2
Slide 28: AK112-303 results to be published at 2024 WCLC
AK112-303 results to be published at 2024 WCLC, The potential best 1L chemo-free therapy AK112-303 / HARMONi-2 : ivonescimab versus pembrolizumab in 1L PD-L1(+) NSCLC (N=398) The success of the HARMONi-2 study also highlights the great value of the synergistic effect of ivonescimab’s MOA of “immuno-
Slide 29: AK112-301 results published at 2024 ASCO
AK112-301 results published at 2024 ASCO AK112-301 / HARMONi-A: ivonescimab + chemo EGFR-TKI resistant nsq-NSCLC (N=322) The results of HARMONi-A study was reported at the world's top oncology academic annual meeting, published in international authoritative journals, and promoting the approval of t
Slide 30: Phase II data of ivonescimab for BTC presented at 2024 ASCO
Phase II data of ivonescimab for BTC were presented at 2024 ASCO, Phase III trial has been initiated ivonescimab + chemo 1L advanced BTC (N=22) Currently, the first-line treatment for A potential better treatment option for advanced BTC is PD-(L)1 combined first-line treatment of advanced biliary wi
Slide 31: Ivonescimab + AK117 Phase III trial initiated
Ivonescimab + AK117 Phase III trial initiated, Phase II results to be published at 2024 ESMO Ivonescimab has shown positive results in Phase II clinical trials for multiple indications PhIII trial initiated ivonescimab + AK117 Global 1st PhIII clinical trial of AK117+IO 1L PD-L1(+) HNSCC combination
Slide 32: Financial Highlights
EX Akesobio Financial Highlights
Slide 33: 2024H1 Financial Highlights
2024H1 Financial Highlights RMB Million 2024H1 2023H1 2022H1 Revenue 1024.74 3676.86 163.14 2024H1, Revenue was RMB1.02billion Net product sales 939.43 757.87 163.14 Net product sales ~RMB 939million, YoY License income1 85.32 2,918.99 - +24.0% increase compared to RMB758 million in 2023H1 Cost
Slide 34: Strong growth of operating income, operating loss continue to narrow
Strong growth of operating income, operating loss continue to narrow Product sales increased strongly Net operating loss* continued to narrow 单位:百万RMB RMB million 单位:百万RMB RMB million 939 -329 758 -452 163 2022H1 2023H1 2024H1 -692 2022H1 2023H1 2024H1 2022H1 2023H1 2024H1 2022H1 2023H1 2024H1 *=net
Slide 35: Akeso Investment Thesis
; LN Akeso Investment Thesis Akesobio + Recently approved ivonescimab is the world’s best-in-class I/O therapy for the treatment of lung cancer, and expected to be SOC for certain types of lung cancer treatment in the near future + Akeso oncology program is anchored by two commercially available bis
Slide 36: Q&A Contact Us
Q&A CONTACT US: ir@akesobio.com