2020 annual results presentation - akeso, inc

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March 2021

2020 Annual Results Presentation

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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 securities of Akeso, Inc. (the “Company”). This presentation does not constitute or contain an offer or invitation to sell, or any solicitation of any offer to subscribe for or purchase any securities in any jurisdiction in which the making of such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction or would not otherwise be in compliance with the laws and regulations of such jurisdiction, and neither this presentation nor anything contained herein shall form the basis of, or be relied upon in connection with, any contract or commitment whatsoever. 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Disclaimer

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Agenda

Product Updates2

Future Milestones and Catalysts3

Financial Highlights4

Overview of Year 20201

SECTION 1

Overview of Year 2020

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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

All In-House Developed Innovative Products

• Cadonilimab(PD-1/CTLA-4, AK104)

• AK112 (PD-1/VEGF)• AK117 (CD47)• Penpulimab

(PD-1, AK105)• AK119 (CD73)• Ebronucimab

(PCSK9, AK102)• AK120 (IL-4R)• AK101 (IL-12/IL223)• AK111 (IL-17)• AK127 (TIGIT)• Others

Note:(1) Akeso Comprehensive Exploration platform

ACE(1)

- Fully Integrated R&D Platform

- Bi-specific TETRABODY technology

• 20+ products in 8 years

• 13 in clinical stage • 4 IND Enabling • 6 Bi-specific programs

Synergistic Collaborations

• Co-development and Commercialization of PD-1 with Sino Biopharma

• Out-licensing to Merck (Quavonlimab, MK-1308, CTLA-4)

World-class GMP Compliant

Manufacturing Facilities

• Current: up to 23,500Lin Zhongshan and Guangzhou

• Guangzhou: up to 40,000L in total

• Zhongshan Cuiheng: up to 40,000L capacity under construction

1 2 3 4

6

40+ clinical trials in running

9 trials in Pivotal/Phase III

22 trials in Phase Ib/II

17 FDA/NMPA IND approvals

Major accomplishments since 2020 to March 2021

Achievements in Clinical Programs (1)

1 NDAsubmission filed

4 registrationaltrials reached endpoints

3 trials obtained registration trial status

2,000+ patientsdosed

126,000+ vials of drugsmanufactured

2 FDA/NMPA breakthrough therapy designation

2 FDA orphan drug designations

2 FDA fast track designations

15 publications in conferences

Note: (1) As of March 2021

https://www.google.com/url?sa=i&url=https://www.astellastrials.com/what-is-a-clinical-trial&psig=AOvVaw04Hv8OpJsl0T0qDhNFGpz0&ust=1616604385591000&source=images&cd=vfe&ved=0CAIQjRxqFwoTCJDqvofvxu8CFQAAAAAdAAAAABAX

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3,500Lin operation

40,000LPhase I in construction

20,000LPhase I in operation

20,000Lin construction

Zhongshan Headquarter

Zhongshan CuihengManufacturing Site

Guangzhou Manufacturing Site


Further expansion of world-class GMP compliant manufacturing facility

23,500LIn operation

83,500LTotal planned capacity

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Achievements in Corporate Operations

ORGANIZATION GROWTHFINANCIALSCAPTIAL MARKETS

R&D ACCELERATION

R&D and clinical staff increase to 507 (1)

employees R&D: 243 (1)

Clinical: 264 (1)

RMB768.6 million spent in R&D

901 employees (1)

4 key senior hires

100+ in commercial team

~HK$4.1 billion (1)

raised

~RMB3.5 billion (1) cash position

Listed on SEHK

Included in:

MSCI China Index Hang Seng Hong

Kong-ListedBiotech Index

Stock Connect Southbound

Note: (1) As of March 2021

Dr. Xinfeng Zhang, Ph.D.SVP (CMC, and MST)

Dr. Jason Ni, Ph.D.SVP (Non-oncology, PV and clinical QC)

Mr. Shi WenjunSVP (Commercialization)

Dr. Michael Chen, Ph.D.VP (BD)

SECTION 2

Product Updates

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Akeso clinical pipeline landscape

Degree of Innovation

P1 P2 P2B P3 or NDA

Degree of Innovation

Source: F&S

IND Enabling/Submission

Immunology and Others

Stage

Oncology

IL12 / IL23

IL17

IL4R

PD1 / CTLA4

VEGFR2

PD1

CD73

PCSK9

PD1 / VEGF

Indication for treating COVID-19

CD73CD47

PD1/LAG3PD1/CD73

TIGIT/TGFbetaTIGIT

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Cadonilimab (AK104)PD-1/CTLA-4 bispecific

12Note 1: data on this page include the data presented in January corporate R&D day 2: data first presented in 2020 annual result presentation3. Includes 2 SDs close to PR

Cadonilimab (PD-1/CTLA-4) – significant progress achieved in 20201

Further solidify our position as the most advanced PD-1 based bi-specific globally

Exciting preliminary/interim results achieved in various small indications (1)

Steady progresses made in combo studies for large indications (1)

• Completed patient enrolment• Obtained FDA fast track and orphan drug,

NMPA breakthrough therapy• Data presented at 2020 China Immuno-

Oncology Conference

• Initiated registrational trial• ORR = 37.3% / 57.1% (PD-L1+)

• ORR = 24%, DCR = 88%• Data presented at ESMO 2020

• ORR = 100% with 2 CRs

• ORR = 75% with 1 CR

Advanced cervicalcancer

3L NPC

≥ 2L Mesothelioma

≥ 3L MSI-H solid tumor

Neuro-endocrine carcinoma

• ORR = 50%, DCR = 100%Indication A (2)

• ORR = 66.2%• DCR = 94.4%• 6mth PFS rate = 67.1%• Data presented at ASCO

GI 2021

1L Gastric cancer

• ORR = 56.3% (3)

• DCR = 100%1L HCC

• Initiated trials in 2H 20201L NSCLC

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Cadonilimab (PD-1/CTLA-4) – clinical development plan1

Focusing on combo trials for large indications and mono trials for unmet medical needs for fast approval.

Drug Candidate TargetComm. Rights Mono / Combo Indication

Status

Phase Ia Phase Ib/IIPivotal/Phase III NDA Submitted

AK104(Cadonilimab)

PD-1 / CTLA-4 Global

Mono 2L/3L cervical cancer

Mono 3L NPC

+XELOX 1L GC orGEJ adenocarcinoma

+Lenvatinib 1L HCC

+Anlotinib 1L NSCLC and 2L/3L NSCLC (PD-(L)1 R/R)

+Chemo 1L NSCLC

+AK119 (CD73) Adv. solid tumors


+AK109 (VEGFR2) 2L GC

RegistrationalTrial

U.S. (Fast Track Designation, Orphan Drug Designation)NMPA: (Breakthrough Therapy Designation)

= In planning= In progress = Completed patient enrollment = Expected first patient in 1H 2021

= Registration trial= Large indications = Global trial

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Cadonilimab (PD-1/CTLA-4) – clinical data summary (Phase Ia)1

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

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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

Cadonilimab (PD-1/CTLA-4) – clinical data summary (cervical cancer)1

Cadonilimab showed superior efficacy in cervical cancer in comparison to either PD-1 plus CTLA-4 combination therapy or PD-1 mono-treatment

Achievements in 2020 and plan for commercialization:

1H 2020

• Initiated registrational trial

Oct 2020

NMPA: breakthrough therapy

Feb 2021

• FDA: orphan drug• Obtained manufacturing licenses, type

B+type C certificate (生产许可B和C证)

Aug 2020

• FDA: fast track• Start to build

commercialization team

Jan 2021

• Completed patient enrollment for in China

2H 2021

• Submit NDA

47.6%

21.6%14.0% 14.3%

0.0%

23.1%

36.4%

66.7%

31.2%

20.0%

53.8%

72.7%ORR DCR

Cadonilimab1

(AK104)Balstilimab

+Zalifrelimab2Balstilimab2 Pembrolizumab3

(PD-L1+)Pembrolizumab3

(PD-L1-)Nivolumab 3 +

Ipilimumab 1 mg/kg4Nivolumab 1 +

Ipilimumab 3 mg/kg4

N=31 N=143 N=160 N=77 N=15 N=26 N=22

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1L Gastric Cancer or GEJ (71 evaluable patients)

Cadonilimab (PD-1/CTLA-4) – clinical data summary (GC/GEJ)1

Cadonilimab in combination with Chemo showed better efficacy and improved 6 month PFS ratein comparison to PD-1 plus chemo combination therapy

ORR = 66.2%, DCR = 94.4%

Cadonilimaball dose level+ mXELOX

(N=71)

Cadonilimab4mg/kg

+ mXELOX

Tislelizumab+ Chemo

Keynote-062PD-L1(+) Pembro

+ Chemo

Checkmate-649Nivo +

FOLFOX/XELOX

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 2021Source: Pembro: KEYNOTE-062 JAMA Oncol. Published online September 3, 2020 Nivo: Checkmate-649Note 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.

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Cadonilimab (PD-1/CTLA-4) – clinical data summary (HCC)1

Source: 1. Presented at: 2020 ASCO Congress. Board #1272. N Engl J Med 2020;382:1894-905. DOI: 10.1056/NEJMoa19157453. Presented at: 2020 ESMO Congress. https://doi.org/10.1016/j.annonc.2020.10.1344. Data cutoff date: Jan 26, 2021

Close to PR

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

43.8% 36.0% 27.3% 20.3%

100.0%88.0%

73.6%

AK104+Lenvatinib Pembrolizuma+Lenvatinib Atezolizumab+Bevacizumab Sintilimab+Bevacizumab

ORR

DCR

N=16 N=100 N=326 N=364

56.3%

ORR / CR benchmarking

https://doi.org/10.1016/j.annonc.2020.10.134

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Cadonilimab (PD-1/CTLA-4) – clinical data summary (NPC)1

3L NPC (17 evaluable patients)

33.3%

57.1%

20.5%

25.9%

20.5% 21.7%

28.2%

ORR, %

Pembrolizumab(N=27c)

Camrelizumab(N=66e)

Nivolumab(N=258b)

Cadonilimaba

(N=17, 7 for PD-L1+)

PD-L1+

PD-L1+PD-L1+

Cadonilimab's ORR rate for NPC were better than Nivolumab, Pembrolizumab, Toripalimab andCamrelizumab

a Date cutoff date: March 25, 2021b Nivolumab: J Clin Oncol 2018 May 10;36(14):1412-1418c Pembrolizumab: Keynote 028, Hsu C 2017 J Clin Onco 35:4050-4056d Toripalimab: POLARIS-02 2020 ASCO, 48 pts were PD-L1 positive and 134 pts were PD-L1 negative e Carrelizumab: CAPTAIN 2020 ESMO

Toripalimab(N=190d)

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Cadonilimab (PD-1/CTLA-4) – clinical data summary (Indication A)1

Indication A – 8 evaluable late stage patients

ORR = 50% (4/8), DCR = 100% (8/8)

Data cutoff date: Mar 2021

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AK112PD-1/VEGF bispecific

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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.

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Drug Candidate Target

Comm. Rights Mono / Combo Indication

Status

Phase IaPhase Ib/II

Pivotal/Phase III

NDA Submitted

AK112 PD-1 /VEGF Global

+Chemo1L NSCLC/

EGFR-TKI failure NSCLC

+Chemo 1L ES-SCLC

Mono 1L NSCLC

Mono Gynecological tumors

Mono Adv. solid tumors


= In planning = Global trial= In progress

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

= Large indications

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2

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.

CategoriesAK112

All dose levels(N = 41)

AK112 20 mg/kg Q2W

(N = 18)

IMmotion151mRCC 1

(Atezo 1200 mg + Bev 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 reportedTRAEs leading to discontinuation 2 (4.9%) 1 (5.6%) 5%

AK112 (PD-1/VEGF) – safety data (Phase Ia)

TRAE：treatment-related adverse event; Atezo: Atezolizumab; Bev: Bevacizumab; RCC: renal cell carcinoma

Data cutoff date: March 19, 2021Note: 1. Brian I Rini, Lancet,2019

AK112 demonstrates better safety profile as compared with Atezolizumab (PD-L1)+Bevacizumab (VEGF) combination therapy

New cutoff date: Mar 2021

Previous cutoff date: Jan 2021

CategoriesAK112

All dose levels(N = 29)

IMmotion151mRCC 1

(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 reportedTRAEs leading to discontinuation 2 (6.9%) 5%

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2

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

AK112 (PD-1/VEGF) – efficacy data (Phase Ia)

Anti-tumor activity of AK112 in Phase Ia trial (N=25, 3-30mg/kg)

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Indication B – late stage cancer patients

2

ORR = 42.9% (3/7), DCR = 85.7% (6/7)

Data cutoff date: March 19, 2021

AK112 (PD-1/VEGF) – efficacy data (Indication B)

Based on reported data, ORR in other existing therapies is in the range of ~15-25% for this indication

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AK117CD47 antibody

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AK117 (CD47) – clinical development plan

Drug Candidate Target

Comm. Rights Mono/Combo Indication

Status

Phase Ia Phase Ib/IIPivotal/Phase III

NDA Submitted

AK117 CD47 Global

+AK104 (PD-1/CTLA-4)

Adv. solid tumors

Mono Solid tumor/lymphoma

+azacitidine MDS

+azacitidine AML

+AK112 (PD-1/VEGF)

Adv. solid tumors

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= In planning= Expected first patient in 1H 2021 = Global trial= In Progress

AK117 is a potential best-in-class anti-CD47 mAB with eliminated hemagglutination effect

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

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AK117Hb % change from baseline by dose level

Hu5F9Hb change with 1 mg/kg priming dose

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

Source: Branimir I Sikic, et al. 2018 ASCO

AK117 (CD47) – no significant reductions in hemoglobin (Hb)

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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 saturation of CD47 on peripheral T cells was achieved at 20 and 30 mg/kg QW for Lemzoparlimab.

Source: Berlin J, et al. 2020 SITC

3 AK117 (CD47) – maximal T-cell receptor occupancy at 3mg/kg QW

Lemzoparlimab Receptor Occupancy of T Cell CD47

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Penpulimab (AK105)PD-1 antibody

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Penpulimab demonstrates potential best-in-class safety profile, and clinically similar or superior to approved anti-PD-1 agents, and ready for global development

Note 1: data on this page include those presented in January corporate R&D day

Penpulimab (PD-1) – significant progress achieved4

PD-1AK105

1 NDA submitted for 3L R/R cHL

Multiple trials reached endpoint(1)

3L NPC: • ORR = 29.7%, DCR = 49.5%• Obtained FDA fast track, orphan drug and

breakthrough therapy designation• Plan for NDA submission

1L SQ NSCLC: • IDMC recommended NDA submission based on

interim analysis results

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.

Steady progresses made in combo studies with Anlotinibfor various indications (1)

Multiple trials reached endpoint (1)

1 NDA submitted for 3L R/R cHL

https://www.google.com/url?sa=i&url=https://www.astellastrials.com/what-is-a-clinical-trial&psig=AOvVaw04Hv8OpJsl0T0qDhNFGpz0&ust=1616604385591000&source=images&cd=vfe&ved=0CAIQjRxqFwoTCJDqvofvxu8CFQAAAAAdAAAAABAX

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Drug Candidate Target Comm.

Rights Mono/Combo IndicationStatus

Phase Ia Phase Ib/II Pivotal/Phase III

NDA Submitted

AK105 PD-1 Global

Mono 3L R/R cHL

Mono ≥3L NPC

+Chemo 1L sq-NSCLC

+Anlotinib 1L nsq-NSCLC

+Anlotinib 1L HCC

+Anlotinib 2L GC

+Chemo 1L nsq-NSCLC

+Anlotinib dMMR

+AnlotinibNSCLC, SCLC, HNC, thyroid cancer, mesothelioma and

thymic cancer

+AnlotinibESCC, UC, GC/GEJ,

cholangiocarcinoma, neuroendocrine tumor (NET)

+Chemo +/- Anlotinib 1L NPC

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

4

= Registration trial= Large indications

RegistrationalTrial

= In progress= Completed

U.S. (Breakthrough Therapy Designation, Fast Track Designation, Orphan Drug Designation)

= Completed patient enrollment

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Sintilimab(N=75b)

Camrelizumab(N=66b)

Tislelizumab(N=65b)

Pembrolizumab(N=210d)

Nivolumab(N=258b)

Penpulimab(N=85a)

Penpulimab (PD-1) – efficacy profile (cHL)4

a: Data cutoff date: Nov 8, 2020b: All efficacy results were obtained from their respective package insertc: Based on Kaplan-Meier estimated: Chen R, Zinzani PL, etc. Blood. Oct 2019

89.4%

82.4%

85.9%87.0%

Sintilimab(N=75b)

Camrelizumab(N=66b)

Tislelizumab(N=65b)

Penpulimab(N=85a)

72.1%62.7% 68.1% 71.6%

ORR, %

6m DOR, % 12m PFS, %

Penpulimab's ORR and CR rate for cHL were better than most of the approved PD-1 agents

89.4%78.7% 77.3% 76.9% 71.9% 69.0% 47.1%

28.0% 31.8%

61.5%

27.6%

14.0%

CR, %

Sintilimab(N=75b)

Camrelizumab(N=66b)

Tislelizumab(N=65b)

Pembrolizumab(N=210d)

Nivolumab(N=258b)

Penpulimab(N=85a)

Sintilimab(N=75b)

Camrelizumab(N=66b)

Tislelizumab(N=65b)

Penpulimab(N=85a)

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29.7%

20.5%

25.9%

20.5%

28.2%

a Date cutoff date : Feb 3 2021, Including 1 confirmed complete response, 32 confirmed partial responseb Nivolumab: J Clin Oncol 2018 May 10;36(14):1412-1418c Pembrolizumab: Keynote 028, Hsu C 2017 J Clin Onco 35:4050-4056d Toripalimab: POLARIS-02 2020 ASCO, 48 pts were PD-L1 positive and 134 pts were PD-L1 negative e Carrelizumab: CAPTAIN 2020 ESMO

Penpulimab (PD-1) – efficacy profile (NPC)4

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

Pembrolizumab(N=27c)

Camrelizumab(N=66e)

Nivolumab(N=258b)

Penpulimab(N=85a)

Toripalimab(N=190d)

ORR, %

PD-L1(+)

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1L Advanced Hepatocellular Carcinoma (HCC) – 29 evaluable patients with 31 patients already enrolled

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

Penpulimab (PD-1) – clinical data summary (HCC) 4

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.

ORR = 31.0%; DCR: 82.8%

Data published in ASCO GI 2021

Notes: Data cutoff date: Nov 13, 2020(1): Imbraveav150 Finn, RS.NEJM 2020: 382;

Best Overall RECIST ResponsePD PR SD

ResponsePenpulimab +

AnlotinibN=31

Atezolizumab +Bevacizuma1

(Imbrave 150 )N=329

ORR, % 31.0 27.3

DCR, % 82.8 74

6-m OS % 93.2 84.8

6-m PFS % 63.2 54.5

Penpulimab + Anlotinib

N=31

Atezolizumab +Bevacizumab1

(Imbrave 150 )N=329

TRAE 90.3% /TRAE（≥ Grade 3） 16.1% 61.1%

SAE 12.9% 38.0%TRAE leading todiscontinuation 9.7% 7.0%

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57.1%

40.0%

18.7%

11.9% 13.0%

Penpulimab (PD-1) – clinical data summary (ES-SCLC)

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

4

Penpulimab in combination with Anlotinib showed better efficacy in comparison to PD-1 inhibitors orAnlotinib monotherapy

Source: Pembro: KEYNOTE-158. Nivo：CHECKMATE-032

2L ES-SCLC (21 patients enrolled in Penpulimab + Anlotinib group)c

ORR benchmarking

Penpulimab+Anlotinib(N=21) a

Penpulimab+Anlotinib

(Pts w/ refractory, N=15) b

Pembrolizumab (N=107)

Nivolumab (N=109)

Anlotinib(N=23)

ORR = 57.1%, DCR = 76.2%

36

Penpulimab (PD-1) – clinical data summary (nsq-NSCLC)

1L nsq-NSCLC (21 evaluable patients with 26 patients already enrolled in Penpulimab + Anlotinib group)

Data cutoff date: Jan 13, 2021

4

ORR = 57.1%, DCR = 90.4%

Penpulimab in combination with Anlotinib showed better efficacy in comparison to PD-1 plus chemo combination therapy

Source: Pembro: KEYNOTE-189 . published at ascopubs.org/journal/jco on March 9, 2020.

Placebo+ Chemo (N=206)

Pembro + Chemo (N=410)

Penpulimab+Anlotinib(N=21)

ORR 19.4% 48.0% 57.1% (12/21)

37

AK119CD73 antibody

38

AK119 (CD73) – clinical development plan

Our development of AK119 is aimed at the treatment of COVID-19 and solid tumors.

5




NDA Submitted

AK119 CD73 Global

Mono COVID-19

Mono Solid tumors


Solid tumors

= In progress = Global trial

Progress achieved in 2020:COVID-19 Completed phase Ia program Phase Ib study in COVID-19 patients in progressSolid tumors Initiated Phase I study of AK119 in combination with AK104 in advanced solid tumors

39

AK109VEGFR-2 antibody

40




NDA Submitted

AK109 VEGFR-2 GlobalMono Adv. solid tumors


2L GC

AK109 (VEGFR-2) – clinical development plan9

= 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

41

Total (N = 11)

8mg/kg Q2W (N = 3)

12mg/kg Q2W (N = 3)

15mg/kg Q3W (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 todiscontinuation 0 0 0 0

Data cutoff date: Feb 23, 2021

AK109 (VEGFR-2) – efficacy and safety profile (Phase Ia)9

ORR = 20% (2/10), DCR = 90% (9/10)

The efficacy and safety profile of AK109 is promising and well-tolerated

42

Ebronucimab (AK102)PCSK9 antibody

43

We have initiated four Phase II trials in patients for various indications in China

Ebronucimab (PCSK9) – clinical development plan6




NDA Submitted

AK102 PCSK9 Global

AK102 / Placebo+ Statin / Ezetimibe Hypercholesterolemia

AK102/ Placebo+ Statin / Ezetimibe HeFH

AK102/ Placebo+ Statin / Ezetimibe HoFH

= In planning= In progress = Completed patient enrollment

Progress achieved in 2020:Hypercholesterolemia Completed Phase II patient enrollment in Feb 2021 Started Phase III safety studiesHeterozygous 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

44

AK120IL-4R antibody

45

7 AK120 (Anti-IL-4R) – clinical development plan




NDA Submitted

AK120 IL-4R Global

Mono Moderate-to-severeatopic dermatitis

Mono Moderate-to-severeasthma

Mono Eosinophilic esophagitis

= In planning= In progress

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 2021Moderate to severe asthma Expected to initiate Phase II for asthma in 2H 2021Eosinophilic esophagitis Expected to initiate Phase II for eosinophilic esophagitis in 2H 2021

= Global trial

46

7 AK120 (Anti-IL-4R) – clinical data summary

EASI 50

AK120

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

Blinded data: Data presented include 10 patients, 8 of which were treated with AK120, 2 of which were treated with placebo

Dupilumab study M4A and M4B: 51 patients treated with dupilumab

Preliminary data from AK120 in Atopic Dermatitis patients

• AK120 is safe and well tolerated. • At week 4，AK120 significantly increases EASI 50. • Preliminary data suggest AK120 is comparable with Dupilumab.

30.0%

85.7%

38.0%

53.0%

71.0%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

75 mg 150 mg 75 mg 150 mg 300 mg

Dupilumab

47

Ebdarokimab (AK101)IL-12/IL-23

48




NDA Submitted

AK101 IL-12/IL-23 Global

Mono Moderate-to-severepsoriasis

Mono Moderate-to-severe ulcerative colitis

Ebdarokimab (IL-12/IL-23) – clinical development plan7

= In planning= In progress

Progress achieved in 2020:Moderate to severe psoriasis Two Phase IIb dose-ranging studies completed patient enrollmentModerate to severe ulcerative colitis (UC) Phase Ib in progress

Future plan in 2021:Moderate to severe psoriasis Expected to initiate Phase III in 2H 2021Moderate 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


49

AK111IL-17A antibody

50

Drug Candidate Target Comm. Rights Mono/Combo Indication

Status

Phase Ia Phase Ib/II Pivotal/Phase III NDA Submitted

AK111 IL-17 Global

Mono Moderate-to-severepsoriasis

Mono Ankylosing spondylitis

AK111 (IL-17) – clinical development plan8

= 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 2021Ankylosing spondylitis Expect to achieve FPI in 1H 2021


51

22.2%

55.6%

33.3%44.4%

12.8%

28.6%

0%

20%

40%

60%

80%

100%

75mg 150mg 300mg 450mg 150mg 300mg

88.9% 88.9%100.0% 100.0%

71.6%81.6%

0%

20%

40%

60%

80%

100%

75mg 150mg 300mg 450mg 150mg 300mg

AK111 (IL-17) – clinical data summary8

PASI 75 PASI 100

AK111

• 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 levelData cutoff date: Mar 8, 2021

AK111

AK111 Secukinumab

Future Milestones and Catalysts

SECTION 3

53

Future milestones and catalysts in 2021

Clinical programs

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)

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

54

Future milestones and catalysts in 2021

Commercialization and Business Development

Commercialization of Penpulimab with CTTQ

Build experienced and strong commercialization team in preparation for the 2022 commercialization of Cadonilimab (AK104, PD-1/CTLA-4)

Actively explore value-accretive strategic partnerships both in China and globally

Manufacturing

Start commercial production of Penpulimab in manufacturing facility in Zhongshan

Start official GMP operation of manufacturing facility in Guangzhou

Further development of manufacturing facility in Guangzhou to increase additional capacity of 8,000L, bringing total capacity to up to 31,500L

SECTION 4

Financial Highlights

56

Operating results

As of December 31,

RMB in millions 2020 2019

Revenue – 70.8

Other income 123.5 50.2

R&D expenses (768.6) (308.4)

Administrative expenses (253.0) (55.4)

Total comprehensive loss (1,552.5) (348.6)

Added:

Fair value changes on preferred shares 412.4 97.4

Share award expenses 347.1 –

Listing expenses 45.5 12.9

Adjusted total comprehensive loss* (747.5) (238.2)

* Adjusted total comprehensive loss represents the lossexcluding the effect brought by fair value changes, listingexpenses and share award expenses.

• Revenue in 2019 represents milestone receipt from our out-licensed product AK107 (MK1308) to Merck.

• Other income mainly consists of interest income and government subsidies for R&D activities.

Revenue1

The increase was mainly due to the increased employee salaries and benefits including share award expenses, and listing expenses.

Administrative expenses3

Such loss represents an non-cash and non-recurring fair value changes on preferred shares.

Fair value changes on preferred shares4

1

3

4

R&D expenses2

The increase of RMB460.2million was mainly due to (i) clinical trial advancement and additional clinical trials for drug candidates; and (ii) increase in R&D headcount and employee salaries and benefits.

2 …

…………

…

57

As at December 31,


Non-current assets 854.8 417.0

Current assets 3,001.3 1,256.0

Current liabilities 170.0 119.8

Net current assets 2,831.4 1,136.2

Non-current liabilities 235.8 1,337.5

Net assets 3,450.4 215.7

As of December 31,


Net cash used in operating activities (617.8) (219.6)

Net cash used in investing activities (555.7) (127.9)

Net cash from financing activities 2,878.3 1,230.2

Cash and cash equivalents 2,684.5 1,186.0

Financial Position

Cash Flow Statement

Balance sheet and cash flow statement

1

2

• The current assets include cash and cash equivalents of RMB2,684.5millions and other current assets of RMB426.8millions.

• The increase in cash and cash equivalents was primarily due to the IPO proceeds.

Current assets1

Capital expenditure2

The increase of RMB427.8million was mainly due to progress made in the construction of Guangzhou facility to enhance development capabilities and expand business operations.

2020 annual results presentation - akeso, inc

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