2020 Annual Results Presentation
March 2021
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2 Agenda
1 Overview of Year 2020
2 Product Updates
3 Future Milestones and Catalysts
4 Financial Highlights
3 SECTION 1
Overview of Year 2020
2 Akeso at a glance
We are a clinical-stage biopharmaceutical company committed to in-house discovery, development and commercialization of first-in-class and best-in-class therapies
Visionary and experienced management team with proven track record of success
1 2 3 4
ACE(1) All In-House Developed Synergistic World-class GMP Innovative Products Collaborations Compliant - Fully Integrated R&D Manufacturing Facilities Platform • Cadonilimab • Co-development and (PD-1/CTLA-4, AK104) Commercialization of • Current: up to 23,500L - Bi-specific TETRABODY • AK112 (PD-1/VEGF) PD-1 with Sino in Zhongshan and
technology • AK117 (CD47) Biopharma Guangzhou • 20+ products in 8 • Penpulimab • Guangzhou: up to (PD-1, AK105) years 40,000L in total • AK119 (CD73) • 13 in clinical stage • Zhongshan Cuiheng: • Ebronucimab up to 40,000L capacity • 4 IND Enabling (PCSK9, AK102) • Out-licensing to Merck under construction • 6 Bi-specific programs • AK120 (IL-4R) (Quavonlimab, MK- • AK101 (IL-12/IL223) 1308, CTLA-4) • AK111 (IL-17) • AK127 (TIGIT) • Others 5 Note: (1) Akeso Comprehensive Exploration platform Major accomplishments since 2020 to March 2021
Achievements in Clinical Programs (1)
1 NDA 40+ clinical trials 2 FDA/NMPA 2,000+ patients submission filed in running breakthrough dosed therapy 4 registrational 9 trials in designation 126,000+ vials trials reached Pivotal/Phase III of drugs endpoints 2 FDA orphan manufactured 22 trials in drug designations 3 trials obtained Phase Ib/II registration trial 2 FDA fast track status 17 FDA/NMPA designations IND approvals 15 publications in conferences
6
Note: (1) As of March 2021 World-class GMP compliant manufacturing facilities
Major accomplishments since 2020 to March 2021
Further expansion of world-class GMP compliant manufacturing facility
Guangzhou Manufacturing Site Zhongshan Headquarter
20,000L 3,500L Phase I in operation in operation 20,000L in construction
Zhongshan Cuiheng Manufacturing Site 40,000L Phase I in construction 23,500L 83,500L In operation Total planned capacity
7 Major accomplishments since 2020 to March 2021
Achievements in Corporate Operations
FINANCIALS R&D ACCELERATION ORGANIZATION GROWTH CAPTIAL MARKETS
~HK$4.1 billion (1) R&D and clinical staff 901 employees (1) raised increase to 507 (1) employees 4 key senior hires ~RMB3.5 billion R&D: 243 (1) (1) cash position Clinical: 264 (1)
Listed on SEHK RMB768.6 million Mr. Shi Wenjun Dr. Jason Ni, Ph.D. spent in R&D SVP (Commercialization) SVP (Non-oncology, Included in: PV and clinical QC)
MSCI China Index Hang Seng Hong
Kong-Listed Dr. Xinfeng Zhang, Ph.D. Dr. Michael Chen, Ph.D. Biotech Index SVP (CMC, and MST) VP (BD) Stock Connect 100+ in commercial Southbound team 8
Note: (1) As of March 2021 SECTION 2
Product Updates
2 Akeso clinical pipeline landscape
Degree of PD1/LAG3 Oncology Innovation PD1 / PD1 / PD1/CD73 TIGIT VEGF CTLA4 TIGIT/TGFbeta
CD47 PD1 CD73
VEGFR2
Stage IND Enabling/ P1 P2 P2B P3 or NDA Submission IL17 IL12 / IL23
IL4R PCSK9
CD73 Immunology Degree of and Others Innovation Indication for treating COVID-19 10 Source: F&S
Cadonilimab (AK104) PD-1/CTLA-4 bispecific
11 1 Cadonilimab (PD-1/CTLA-4) – significant progress achieved in 2020
Steady progresses made in combo Exciting preliminary/interim results achieved in studies for large indications (1) various small indications (1)
• Completed patient enrolment • ORR = 66.2% • Obtained FDA fast track and orphan drug, • DCR = 94.4% Advanced NMPA breakthrough therapy • 6mth PFS rate = 67.1% 1L Gastric cervical • Data presented at 2020 China Immuno- cancer • Data presented at ASCO cancer Oncology Conference GI 2021 • Initiated registrational trial 3L NPC • ORR = 37.3% / 57.1% (PD-L1+)
• ORR = 56.3% (3) ≥ 2L • ORR = 24%, DCR = 88% Mesothelioma 1L HCC • DCR = 100% • Data presented at ESMO 2020
≥ 3L MSI-H • ORR = 100% with 2 CRs solid tumor
Neuro- endocrine • ORR = 75% with 1 CR carcinoma • Initiated trials in 2H 2020 1L NSCLC Indication A (2) • ORR = 50%, DCR = 100%
Further solidify our position as the most advanced PD-1 based bi-specific globally
Note 1: data on this page include the data presented in January corporate R&D day 12 2: data first presented in 2020 annual result presentation 3. Includes 2 SDs close to PR 1 Cadonilimab (PD-1/CTLA-4) – clinical development plan
Focusing on combo trials for large indications and mono trials for unmet medical needs for fast approval.
Status Comm. Pivotal/ Drug Candidate Target Rights Mono / Combo Indication Phase Ia Phase Ib/II Phase III NDA Submitted
U.S. (Fast Track Designation, Mono 2L/3L cervical cancer Orphan Drug Designation) NMPA: (Breakthrough Therapy Mono 3L NPC Designation) 1L GC or Registrational +XELOX GEJ adenocarcinoma Trial +Lenvatinib 1L HCC
AK104 PD-1 / 1L NSCLC and 2L/3L Global +Anlotinib (Cadonilimab) CTLA-4 NSCLC (PD-(L)1 R/R)
+Chemo 1L NSCLC
+AK119 (CD73) Adv. solid tumors
+AK117 (CD47) Adv. solid tumors
+AK109 (VEGFR2) 2L GC
= Completed patient enrollment = In progress = Expected first patient in 1H 2021 = In planning
= Large indications = Registration trial = Global trial
13 1 Cadonilimab (PD-1/CTLA-4) – clinical data summary (Phase Ia)
Anti-tumor activity of Cadonilimab in Australia Phase Ia trial (N=55, 2mg-25mg/kg)
ORR=27.3% (15/55), DCR=60% (33/55) (ORR = 27.5% (14/51), DCR = 56.9% (29/51) at previous cutoff date in Nov 2020)
Data cutoff date: Mar 2021
14 1 Cadonilimab (PD-1/CTLA-4) – clinical data summary (cervical cancer)
Cadonilimab showed superior efficacy in cervical cancer in comparison to either PD-1 plus CTLA-4 combination therapy or PD-1 mono-treatment 72.7% 66.7% ORR DCR
53.8% 47.6% 36.4% 31.2% 23.1% 21.6% 20.0% 14.0% 14.3%
0.0%
Cadonilimab1 Balstilimab Balstilimab2 Pembrolizumab3 Pembrolizumab3 Nivolumab 3 + Nivolumab 1 + (AK104) +Zalifrelimab2 (PD-L1+) (PD-L1-) Ipilimumab 1 mg/kg4 Ipilimumab 3 mg/kg4 N=31 N=143 N=160 N=77 N=15 N=26 N=22
1. Data cutoff date: July 2020, 31 patients enroled with 21 patients evaluable for efficacy. The efficacy data as of today remain consistent with the data in July. 2. Presented at: 2020 ESMO Congress; September 20, 2020; virtual. Abstract LBA34. 3. Chung HC, et al,Journal of Clinical Oncology, 2019, 37, no.17, 1470-1478. 4. Results from CheckMate 358. Proffered Paper, Abstract 5630. ESMO 2019. * PST: Prior Systemic Therapy
Achievements in 2020 and plan for commercialization:
• FDA: orphan drug • Initiated NMPA: • Obtained manufacturing licenses, type registrational trial breakthrough therapy B+type C certificate (生产许可B和C证)
1H Aug Oct Jan Feb 2H 2020 2020 2020 2021 2021 2021
• FDA: fast track • Completed patient • Submit NDA 15 • Start to build enrollment for in China commercialization team 1 Cadonilimab (PD-1/CTLA-4) – clinical data summary (GC/GEJ)
1L Gastric Cancer or GEJ (71 evaluable patients)
ORR = 66.2%, DCR = 94.4%
Cadonilimab in combination with Chemo showed better efficacy and improved 6 month PFS rate in comparison to PD-1 plus chemo combination therapy Cadonilimab Cadonilimab Keynote-062 Checkmate-649 all dose level Tislelizumab+ 4mg/kg PD-L1(+) Pembro Nivo + + mXELOX Chemo + mXELOX + Chemo FOLFOX/XELOX (N=71) median follow-up (months) 4.9 11.4 15.4 22.6 12.1 (minimum) ORR 66.2% 68.8% 46.7% 48.6% 58.0% DCR 94.4% 93.8% 80.0% - - median PFS (months) NR 9.6 6.1 6.9 7.7
6-month PFS rate (%) 67.1% (1) 76.5% Not reported 53% /
Data cutoff date: Mar 2021 Source: Pembro: KEYNOTE-062 JAMA Oncol. Published online September 3, 2020 Nivo: Checkmate-649 Note 1: median follow-up for dose level > 4mg/kg less than 6 months. Therefore, 6-month PFS rate is not mature as of data cut. 16 1 Cadonilimab (PD-1/CTLA-4) – clinical data summary (HCC)
1L Hepatocellular Carcinoma (HCC) – 16 evaluable patients for antitumor activity (i.e. with the opportunity to be followed for at least 2 scans) with 30 patients already enrolled
Close to PR
ORR / CR benchmarking 100.0% ORR 88.0% 73.6% DCR 56.3%
43.8% 36.0% 27.3% 20.3%
AK104+Lenvatinib Pembrolizuma+Lenvatinib Atezolizumab+Bevacizumab Sintilimab+Bevacizumab N=16 N=100 N=326 N=364
Source: 1. Presented at: 2020 ASCO Congress. Board #127 2. N Engl J Med 2020;382:1894-905. DOI: 10.1056/NEJMoa1915745 3. Presented at: 2020 ESMO Congress. https://doi.org/10.1016/j.annonc.2020.10.134 17 4. Data cutoff date: Jan 26, 2021 1 Cadonilimab (PD-1/CTLA-4) – clinical data summary (NPC)
3L NPC (17 evaluable patients)
ORR, % PD-L1+ 57.1%
33.3% PD-L1+ 28.2% 25.9% PD-L1+ 20.5% 20.5% 21.7%
Cadonilimaba Nivolumab Pembrolizumab Toripalimab Camrelizumab (N=17, 7 for PD-L1+) (N=258b) (N=27c) (N=190d) (N=66e)
Cadonilimab's ORR rate for NPC were better than Nivolumab, Pembrolizumab, Toripalimab and Camrelizumab a Date cutoff date: March 25, 2021 b Nivolumab: J Clin Oncol 2018 May 10;36(14):1412-1418 c Pembrolizumab: Keynote 028, Hsu C 2017 J Clin Onco 35:4050-4056 18 d Toripalimab: POLARIS-02 2020 ASCO, 48 pts were PD-L1 positive and 134 pts were PD-L1 negative e Carrelizumab: CAPTAIN 2020 ESMO 1 Cadonilimab (PD-1/CTLA-4) – clinical data summary (Indication A)
Indication A – 8 evaluable late stage patients
ORR = 50% (4/8), DCR = 100% (8/8)
Data cutoff date: Mar 2021
19 AK112 PD-1/VEGF bispecific
20 2 AK112 (PD-1/VEGF) – clinical development plan
We are executing a global clinical development strategy for AK112. Started Phase I trial for the treatment of advanced solid tumors in Australia in October 2019. Status Drug Comm. Phase Pivotal/ NDA Candidate Target Rights Mono / Combo Indication Phase Ia Ib/II Phase III Submitted 1L NSCLC/ +Chemo EGFR-TKI failure NSCLC
+Chemo 1L ES-SCLC PD-1 / AK112 Global VEGF Mono 1L NSCLC
Mono Gynecological tumors
Mono Adv. solid tumors
+AK117 (CD47) Adv. solid tumors
= In progress = In planning = Global trial = Large indications
Progress achieved in 2020: Obtained NMPA approval to initiate Phase Ib trial for advanced solid tumors in China Initiated multiple Phase Ib/II studies Phase Ia data was presented at 2020 China Immuno-Oncology Conference
21 2 AK112 (PD-1/VEGF) – safety data (Phase Ia)
. As of 19 March 2021, 41 subjects were enrolled in 6 cohorts: 0.3mg/kg (n=1), 1mg/kg (n=3), 3mg/kg (n=3), 10mg/kg (n=13), 20mg/kg Q2W (n=18), 30mg/kg Q2W (n=3). . Of all 41 subjects, no DLT occurred. New cutoff date: Mar 2021 IMmotion151 AK112 AK112 mRCC 1 Categories All dose levels 20 mg/kg Q2W (Atezo 1200 mg + Bev (N = 41) (N = 18) 15mg/kg Q3W) TRAE 26 (63.4%) 10 (55.6%) 91% ≥ Grade 3 TRAE 8 (19.5%) 3 (16.7%) 40% Drug-related SAE 1 (2.4%) 0 Not reported TRAEs leading to 2 (4.9%) 1 (5.6%) 5% discontinuation TRAE：treatment-related adverse event; Atezo: Atezolizumab; Bev: Bevacizumab; RCC: renal cell carcinoma Previous cutoff date: Jan 2021 AK112 IMmotion151 Categories All dose levels mRCC 1 (N = 29) (Atezo 1200 mg + Bev 15mg/kg Q3W) TRAE 16 (55.2%) 91% ≥ Grade 3 TRAE 3 (10.3%) 40% Drug-related SAE 1 (3.4%) Not reported TRAEs leading to 2 (6.9%) 5% discontinuation
AK112 demonstrates better safety profile as compared with Atezolizumab (PD-L1)+Bevacizumab (VEGF) combination therapy
Data cutoff date: March 19, 2021 22 Note: 1. Brian I Rini, Lancet,2019 2 AK112 (PD-1/VEGF) – efficacy data (Phase Ia)
Anti-tumor activity of AK112 in Phase Ia trial (N=25, 3-30mg/kg)
ORR = 24.0% (6/25), DCR = 72.4% (18/25) (ORR = 23.5% (4/17), DCR = 64.7% (11/17) at previous cutoff date in Jan 2021)
Data cutoff date: March 19, 2021 23 2 AK112 (PD-1/VEGF) – efficacy data (Indication B)
Indication B – late stage cancer patients
ORR = 42.9% (3/7), DCR = 85.7% (6/7)
Based on reported data, ORR in other existing therapies is in the range of ~15-25% for this indication
Data cutoff date: March 19, 2021 24 AK117 CD47 antibody
25 3 AK117 (CD47) – clinical development plan
AK117 is a potential best-in-class anti-CD47 mAB with eliminated hemagglutination effect
Status Drug Comm. Pivotal/ NDA Candidate Target Rights Mono/Combo Indication Phase Ia Phase Ib/II Phase III Submitted +AK104 Adv. solid tumors (PD-1/CTLA-4) Solid tumor/ Mono lymphoma
AK117 CD47 Global +azacitidine MDS
+azacitidine AML
+AK112 Adv. solid tumors (PD-1/VEGF)
= In Progress = Expected first patient in 1H 2021 = In planning = Global trial
Progress achieved in 2020: Advanced solid tumors/lymphoma Initiated trials for solid tumor/lymphoma Completed 0.3, 1, 3, 10, 20 and 30mg/kg QW dose escalation cohorts without need of a priming dose No significant effect on hemoglobin and reticulocytes observed up to 30mg/kg QW Expected to commence enrollment of 45 mg/kg QW (MAD) cohort in April 2021 In the process of starting AK117 + AK104 combo in advanced solid tumors
26 3 AK117 (CD47) – no significant reductions in hemoglobin (Hb)
AK117 Hu5F9 Hb % change from baseline by dose level Hb change with 1 mg/kg priming dose
Source: Branimir I Sikic, et al. 2018 ASCO
AK117 does not require administration of a priming dose AK117 at up to 30 mg/kg, inclusive, does not cause significant reduction in hemoglobin levels In comparison, an approximately 20% reduction in hemoglobin levels was observed with a 1 mg/kg priming dose of Hu5F9
27 3 AK117 (CD47) – maximal T-cell receptor occupancy at 3mg/kg QW
AK117 Receptor Occupancy of T Cell CD47
AK117 demonstrated dose dependent increase in CD47 RO on peripheral T cells.
AK117 achieved consistent maximal saturation of CD47 on peripheral T cells after just 2 doses at 3mg/kg QW.
In comparison, maximal Lemzoparlimab Receptor Occupancy of T Cell CD47 saturation of CD47 on peripheral T cells was achieved at 20 and 30 mg/kg QW for Lemzoparlimab.
28 Source: Berlin J, et al. 2020 SITC Penpulimab (AK105) PD-1 antibody
29 4 Penpulimab (PD-1) – significant progress achieved
11 NDANDA submittedsubmitted forfor 3L3L R/RR/R cHLcHL
(1) MultipleMultiple trialstrials reachedreached endpointendpoint(1) 3L NPC: • ORR = 29.7%, DCR = 49.5% PD-1 • Obtained FDA fast track, orphan drug and breakthrough therapy designation AK105 • Plan for NDA submission 1L SQ NSCLC: • IDMC recommended NDA submission based on interim analysis results
Steady progresses made in combo studies with Anlotinib for various indications (1)
1L HCC: • ORR = 31.0%, DCR = 82.8%, Data presented at ASCO GI 2020 2L ES-SCLC: ORR = 57.1%, DCR = 76.2% Initiated studies for NSCLC, SCLC, ESCC, UC, GC/GEJ, HNC, thyroid cancer, mesothelioma, thymic cancer, NET and etc.
Penpulimab demonstrates potential best-in-class safety profile, and clinically similar or superior to approved anti-PD-1 agents, and ready for global development
30
Note 1: data on this page include those presented in January corporate R&D day 4 Penpulimab (PD-1) – clinical development plan
Focusing on combo trials with Chemo or Anlotinib for large indications, combined with monotherapy trials for niche indications for rapid approval
Status Drug Comm. Target Mono/Combo Indication Pivotal/ NDA Candidate Rights Phase Ia Phase Ib/II Phase III Submitted
Mono 3L R/R cHL U.S. (Breakthrough Therapy Designation, Fast Track Mono ≥3L NPC Designation, Orphan Drug Designation) +Chemo 1L sq-NSCLC
+Anlotinib 1L nsq-NSCLC
Registrational +Anlotinib 1L HCC Trial +Anlotinib 1L GC AK105 PD-1 Global +Chemo 1L nsq-NSCLC
+Anlotinib dMMR NSCLC, SCLC, HNC, thyroid +Anlotinib cancer, mesothelioma and thymic cancer ESCC, UC, GC/GEJ, +Anlotinib cholangiocarcinoma, neuroendocrine tumor (NET) +Chemo +/- Anlotinib 1L NPC
= Completed = Completed patient enrollment = In progress = Large indications = Registration trial
31 4 Penpulimab (PD-1) – efficacy profile (cHL)
ORR, % CR, % 61.5% 89.4% 78.7% 77.3% 76.9% 47.1% 71.9% 69.0% 31.8% 28.0% 27.6%
14.0%
Penpulimab Sintilimab Camrelizumab Tislelizumab Pembrolizumab Nivolumab Penpulimab Sintilimab Camrelizumab Tislelizumab Pembrolizumab Nivolumab (N=85a) (N=75b) (N=66b) (N=65b) (N=210d) (N=258b) (N=85a) (N=75b) (N=66b) (N=65b) (N=210d) (N=258b)
6m DOR, % 12m PFS, %
89.4% 72.1% 68.1% 71.6% 87.0% 62.7% 85.9%
82.4%
Penpulimab Sintilimab Camrelizumab Tislelizumab Penpulimab Sintilimab Camrelizumab Tislelizumab (N=85a) (N=75b) (N=66b) (N=65b) (N=85a) (N=75b) (N=66b) (N=65b)
Penpulimab's ORR and CR rate for cHL were better than most of the approved PD-1 agents
a: Data cutoff date: Nov 8, 2020 b: All efficacy results were obtained from their respective package insert c: Based on Kaplan-Meier estimate d: Chen R, Zinzani PL, etc. Blood. Oct 2019 32 4 Penpulimab (PD-1) – efficacy profile (NPC)
ORR, %
29.7% PD-L1(+) 28.2% 25.9%
20.5% 20.5%
Penpulimab Nivolumab Pembrolizumab Toripalimab Camrelizumab (N=85a) (N=258b) (N=27c) (N=190d) (N=66e)
For NPC, Penpulimab‘s ORR was better than most of the approved PD-1 agents. Our NPC trial received FDA fast track, orphan drug and breakthrough therapy designation a Date cutoff date : Feb 3 2021, Including 1 confirmed complete response, 32 confirmed partial response b Nivolumab: J Clin Oncol 2018 May 10;36(14):1412-1418 c Pembrolizumab: Keynote 028, Hsu C 2017 J Clin Onco 35:4050-4056 d Toripalimab: POLARIS-02 2020 ASCO, 48 pts were PD-L1 positive and 134 pts were PD-L1 negative e Carrelizumab: CAPTAIN 2020 ESMO
33
4 Penpulimab (PD-1) – clinical data summary (HCC)
Data published in ASCO GI 2021 1L Advanced Hepatocellular Carcinoma (HCC) – 29 evaluable patients with 31 patients already enrolled
Best Overall RECIST Response PD PR SD ORR = 31.0%; DCR: 82.8%
Penpulimab (PD-1) in combination with Anlotinib had a manageable safety profile and encouraging anti- tumor activities as first-line therapy in patients with advanced HCC
Atezolizumab Atezolizumab Penpulimab + Penpulimab + +Bevacizuma1 +Bevacizumab1 Response Anlotinib Anlotinib (Imbrave 150 ) (Imbrave 150 ) N=31 N=31 N=329 N=329 ORR, % 31.0 27.3 TRAE 90.3% /
DCR, % 82.8 74 TRAE（≥ Grade 3） 16.1% 61.1% SAE 6-m OS % 93.2 84.8 12.9% 38.0% TRAE leading to 9.7% 7.0% 6-m PFS % 63.2 54.5 discontinuation . Evaluation of penpulimab (200 mg iv q3w) in combination with higher dose of anlotinib (10 mg qd day1-14, q3w) in a phase 3 study for first-line HCC versus sorafenib (NCT04344158) is currently underway.
Notes: Data cutoff date: Nov 13, 2020 34 (1): Imbraveav150 Finn, RS.NEJM 2020: 382; 4 Penpulimab (PD-1) – clinical data summary (ES-SCLC)
2L ES-SCLC (21 patients enrolled in Penpulimab + Anlotinib group)c ORR benchmarking 57.1% ORR = 57.1%, DCR = 76.2%
40.0%
18.7% 11.9% 13.0%
Penpulimab Penpulimab Pembrolizumab Nivolumab Anlotinib +Anlotinib +Anlotinib (N=107) (N=109) (N=23) (N=21) a (Pts w/ refractory, N=15) b
Penpulimab in combination with Anlotinib showed better efficacy in comparison to PD-1 inhibitors or Anlotinib monotherapy
Source: Pembro: KEYNOTE-158. Nivo：CHECKMATE-032 Notes: a. Unconfirmed ORR (11/21, 1 CR and 10 PR); Confirmed ORR (9/21, 1 CR and 8 PR), responders remained in response with DoR ranging from 1.5+ to 6.1+ months; b. The confirmed ORR in patients with refractory disease (relapsed within 3 months after first-line treatment) (6/15); c. Data cutoff date: Mar 1, 2021
35 4 Penpulimab (PD-1) – clinical data summary (nsq-NSCLC)
1L nsq-NSCLC (21 evaluable patients with 26 patients already enrolled in Penpulimab + Anlotinib group)
ORR = 57.1%, DCR = 90.4%
Penpulimab in combination with Anlotinib showed better efficacy in comparison to PD-1 plus chemo combination therapy
Placebo+ Chemo Pembro + Chemo Penpulimab+Anlotinib (N=206) (N=410) (N=21)
ORR 19.4% 48.0% 57.1% (12/21)
Source: Pembro: KEYNOTE-189 . published at ascopubs.org/journal/jco on March 9, 2020. 36 Data cutoff date: Jan 13, 2021 AK119 CD73 antibody
37 5 AK119 (CD73) – clinical development plan
Our development of AK119 is aimed at the treatment of COVID-19 and solid tumors.
Status Drug Comm. Target Mono/Combo Indication Pivotal/ NDA Candidate Rights Phase Ia Phase Ib/II Phase III Submitted
Mono COVID-19
AK119 CD73 Global Mono Solid tumors
+AK104 Solid tumors (PD-1/CTLA-4)
= In progress = Global trial
Progress achieved in 2020: COVID-19 Completed phase Ia program Phase Ib study in COVID-19 patients in progress Solid tumors Initiated Phase I study of AK119 in combination with AK104 in advanced solid tumors
38 AK109 VEGFR-2 antibody
39 9 AK109 (VEGFR-2) – clinical development plan
Status Drug Comm. Target Mono/Combo Indication Candidate Rights Pivotal/ NDA Phase Ia Phase Ib/II Phase III Submitted
Mono Adv. solid tumors AK109 VEGFR-2 Global +AK104 2L GC (PD-1/CTLA-4)
= In progress = Expected first patient in 1H 2021
Progress achieved in 2020: Advanced solid tumors Completed dose escalation in Phase Ia
Future plan in 2021: Gastric cancer Plan to initiate combo studies with AK104 in 1H 2021
40 9 AK109 (VEGFR-2) – efficacy and safety profile (Phase Ia)
ORR = 20% (2/10), DCR = 90% (9/10)
Total 8mg/kg Q2W 12mg/kg Q2W 15mg/kg Q3W
(N = 11) (N = 3) (N = 3) (N = 3) TRAE 13 (92.9) 2 (66.7) 3 (100.0) 3 (100.0) TRAE (≥ Grade 3） 1 (7.1) 0 1 (33.3) 0 TRSAE 1 (7.1) 0 0 1 (33.3) TRAE leading to 0 0 0 0 discontinuation
The efficacy and safety profile of AK109 is promising and well-tolerated
Data cutoff date: Feb 23, 2021 41 Ebronucimab (AK102) PCSK9 antibody
42 6 Ebronucimab (PCSK9) – clinical development plan
We have initiated four Phase II trials in patients for various indications in China
Status Drug Comm. Target Mono/Combo Indication Pivotal/ NDA Candidate Rights Phase Ia Phase Ib/II Phase III Submitted AK102 / Placebo+ Hypercholesterolemia Statin / Ezetimibe AK102/ Placebo+ HeFH AK102 PCSK9 Global Statin / Ezetimibe AK102/ Placebo+ HoFH Statin / Ezetimibe
= Completed patient enrollment = In progress = In planning
Progress achieved in 2020: Hypercholesterolemia Completed Phase II patient enrollment in Feb 2021 Started Phase III safety studies Heterozygous Familial Hypercholesterolemia (HeFH) Enrolled the first patient in Phase II trial for HeFH Future plan in 2021: Hypercholesterolemia Expect to start Phase III efficacy studies in 2H 2021
43 AK120 IL-4R antibody
44 7 AK120 (Anti-IL-4R) – clinical development plan
Status Drug Comm. Target Mono/Combo Indication Pivotal/ NDA Candidate Rights Phase Ia Phase Ib/II Phase III Submitted Moderate-to-severe Mono atopic dermatitis
Moderate-to-severe AK120 IL-4R Global Mono asthma
Mono Eosinophilic esophagitis
= In progress = In planning = Global trial
Progress achieved in 2020: Moderate to severe atopic dermatitis Started Phase I dose-ranging studies to evaluate AK120 optimal dose and dosing schedule FDA IND granted in Dec 2020
Future plan in 2021: Moderate to severe atopic dermatitis Expected to initiate Phase II in 2H 2021 Moderate to severe asthma Expected to initiate Phase II for asthma in 2H 2021 Eosinophilic esophagitis Expected to initiate Phase II for eosinophilic esophagitis in 2H 2021 45 7 AK120 (Anti-IL-4R) – clinical data summary
EASI 50 Preliminary data from AK120 in Atopic Dermatitis patients
90% 85.7%
80% 71.0% 70% Blinded data: Data presented include 60% 53.0% 10 patients, 8 of which were treated 50% with AK120, 2 of which were treated 38.0% with placebo 40% 30.0% 30% Dupilumab study M4A and M4B: 51 patients treated with dupilumab 20%
10%
0% 75 mg 150 mg 75 mg 150 mg 300 mg
AK120 Dupilumab
• AK120 is safe and well tolerated. • At week 4，AK120 significantly increases EASI 50. • Preliminary data suggest AK120 is comparable with Dupilumab.
Ssource: Beck LA, Thaçi D, Hamilton JD, Graham NM, Bieber T, Rocklin R, Ming JE, Ren H, Kao R, Simpson E, Ardeleanu M, Weinstein SP, Pirozzi G, Guttman-Yassky E, Suárez-Fariñas M, Hager MD, Stahl N, Yancopoulos GD, Radin AR. Dupilumab treatment in adults with moderate-to-severe atopic dermatitis. N Engl J Med. 2014 Jul 10;371(2):130-9. doi: 10.1056/NEJMoa1314768. PMID: 25006719. Data cutoff date: Mar 10, 2021
46 Ebdarokimab (AK101) IL-12/IL-23
47 7 Ebdarokimab (IL-12/IL-23) – clinical development plan
Status Drug Comm. Target Mono/Combo Indication Pivotal/ NDA Candidate Rights Phase Ia Phase Ib/II Phase III Submitted
Moderate-to-severe Mono psoriasis AK101 IL-12/IL-23 Global Moderate-to-severe Mono ulcerative colitis
= Completed patient enrollment = In progress = In planning
Progress achieved in 2020: Moderate to severe psoriasis Two Phase IIb dose-ranging studies completed patient enrollment Moderate to severe ulcerative colitis (UC) Phase Ib in progress
Future plan in 2021: Moderate to severe psoriasis Expected to initiate Phase III in 2H 2021 Moderate to severe ulcerative colitis (UC) Expect to have data readout for Phase Ib for UC in 2H 2021 Expected to initiate Phase II in 2H 2021
48 AK111 IL-17A antibody
49 8 AK111 (IL-17) – clinical development plan
Status Drug Target Comm. Rights Mono/Combo Indication Candidate Pivotal/ Phase Ia Phase Ib/II NDA Submitted Phase III
Moderate-to-severe Mono psoriasis AK111 IL-17 Global Ankylosing Mono spondylitis
= Completed patient enrollment = Expected first patient in 1H 2021
Progress achieved in 2020: Moderate-to-severe psoriasis Received IND approval Phase Ib/II dose-ranging study completed patient enrollment
Future plan in 2021: Moderate-to-severe psoriasis Expect to initiate Phase II/III in 2H 2021 Ankylosing spondylitis Expect to achieve FPI in 1H 2021
50 8 AK111 (IL-17) – clinical data summary
PASI 75 PASI 100
100% 100.0% 100.0% 88.9% 88.9% 81.6% 100% 80% 71.6% 80%
60% 60% 55.6% 44.4% 40% 33.3% 40% 28.6% 22.2% 20% 20% 12.8%
0% 0% 75mg 150mg 300mg 450mg 150mg 300mg 75mg 150mg 300mg 450mg 150mg 300mg
AK111 AK111 AK111 Secukinumab
• AK111 is safe and well tolerated. • At week 12, AK111 significantly increased PASI 75, and PASI 100，and the efficacy was maintained after 12 weeks when the scheduled treatment was ended. • Preliminary data suggest AK111 is comparable with Secukinumab
Source: Langley RG, Elewski BE, Lebwohl M, Reich K, Griffiths CE, Papp K, Puig L, Nakagawa H, Spelman L, Sigurgeirsson B, Rivas E, Tsai TF, Wasel N, Tyring S, Salko T, Hampele I, Notter M, Karpov A, Helou S, Papavassilis C; ERASURE Study Group; FIXTURE Study Group. Secukinumab in plaque psoriasis--results of two phase 3 trials. N Engl J Med. 2014 Jul 24;371(4):326-38. doi: 10.1056/NEJMoa1314258. Epub 2014 Jul 9. PMID: 25007392. Note: AK111, n=9 for each dose level, Secukinumab: n= 245 for each dose level Data cutoff date: Mar 8, 2021
51 SECTION 3
Future Milestones and Catalysts
3 Future milestones and catalysts in 2021
Receive NDA approval for Penpulimab (PD-1) in 3L R/R cHL File NDA for Cadonilimab (PD-1/CTLA-4) in 2L/3L cervical cancer File NDA for Penpulimab (PD-1) in >=3L NPC File NDA for Penpulimab (PD-1) in combination with chemotherapy for 1L sq-NSCLC Start Phase III/Pivotal trials for: Cadonilimab (PD-1/CTLA-4, AK104) Penpulimab (PD-1, AK105) AK101 (IL-12/IL-23) AK102 (PCSK9) Clinical programs Start Phase II trials for: Cadonilimab (PD-1/CTLA-4, AK104) Penpulimab (PD-1, AK105) AK112 (PD-1/VEGF) AK117 (CD47) AK119 (CD73) AK109 (VEGFR-2) AK111 (IL-17) AK120 (IL-4R) Advance AK127 (TIGIT) into clinical stage
53 Future milestones and catalysts in 2021
Commercialization of Penpulimab with CTTQ
Commercialization Build experienced and strong commercialization team in preparation and Business for the 2022 commercialization of Cadonilimab (AK104, PD-1/CTLA-4) Development Actively explore value-accretive strategic partnerships both in China and globally
Start commercial production of Penpulimab in manufacturing facility in Zhongshan
Start official GMP operation of manufacturing facility in Guangzhou Manufacturing Further development of manufacturing facility in Guangzhou to increase additional capacity of 8,000L, bringing total capacity to up to 31,500L
54 SECTION 4
Financial Highlights Operating results
As of December 31, 1 Revenue
RMB in millions 2020 2019 • Revenue in 2019 represents milestone receipt from our out-licensed product AK107 (MK1308) to Merck.
• Other income mainly consists of interest income and 1 Revenue – 70.8 government subsidies for R&D activities.
Other income 123.5 50.2
2 R&D expenses 2 R&D expenses (768.6) (308.4) … The increase of RMB460.2million was mainly due to (i) Administrative clinical trial advancement and additional clinical trials 3 (253.0) (55.4) expenses for drug candidates; and (ii) increase in R&D headcount … and employee salaries and… benefits. Total comprehensive loss (1,552.5) (348.6)
Added: 3 Administrative expenses Fair value changes on 4 412.4 97.4 preferred shares The increase was mainly due to the increased employee salaries and benefits including share award expenses, Share award expenses 347.1 – and listing expenses. Listing expenses 45.5 12.9
Adjusted total (747.5) (238.2) comprehensive loss* 4 Fair value changes on preferred shares
Such loss represents an non-cash and non-recurring fair * Adjusted total comprehensive loss represents the loss value changes on preferred shares. excluding the effect brought by fair value changes, listing expenses and share award expenses.
56 Balance sheet and cash flow statement
Financial Position
As at December 31, RMB in millions 2020 2019 1 Current assets
Non-current assets 854.8 417.0 • The current assets include cash and cash equivalents of RMB2,684.5millions and other current assets of 1 Current assets 3,001.3 1,256.0 RMB426.8millions.
Current liabilities 170.0 119.8 • The increase in cash and cash equivalents was primarily due to the IPO proceeds. Net current assets 2,831.4 1,136.2
Non-current liabilities 235.8 1,337.5
Net assets 3,450.4 215.7
Cash Flow Statement
As of December 31, RMB in millions 2020 2019 2 Capital expenditure
Net cash used in operating activities (617.8) (219.6) The increase of RMB427.8million was mainly due to progress made in the construction of Guangzhou facility 2 Net cash used in investing activities (555.7) (127.9) to enhance development capabilities and expand business operations. Net cash from financing activities 2,878.3 1,230.2
Cash and cash equivalents 2,684.5 1,186.0
57 Q&A
3