Astrazeneca Plc · LSE:AZN

Astrazeneca — Q1 2018 Earnings Presentation

113 slides from Astrazeneca's earnings presentation, 2018

1. Slide 1: Clinical trials appendix Q1 2018 Results update

   Clinical trials appendix Q1 2018 Results update

2. Slide 2: About the clinical trials information

   The following information about AstraZeneca clinical trials in Phases I-IV has been created with selected information from https://clinicaltrials.gov to facilitate understanding of key aspects of ongoing clinical programmes and is correct to the best of the Company’s knowledge as of 31 March 2018, u

3. Slide 3: List of abbreviations

   List of abbreviations AE Adverse Event LCM Lifecycle Management PD Pharmacodynamics AUC Area Under Curve LPCD Last Patient Commenced Dosing Q2W Quaque (every) Two Weeks BID Bis In Die (two times a day) MAD Multiple Ascending Dose Q3W Quaque (every) Three Weeks CE Clinically Evaluable MDI Metered-Dos

4. Slide 4: Table of contents

   Table of contents slide Early development - IMED (AstraZeneca Research & Early Development) Movement since Q4 2017 results announcement Oncology Q1 2018 New Molecular Entity (NME) pipeline CVRM Q1 2018 Lifecycle Management (LCM) pipeline Respiratory Other Approved medicines Oncology Cardiovascular,

5. Slide 5: Movement since Q4 2017 update

   Movement since Q4 2017 update New to Phase I New to Phase II New to Pivotal Study New to Registration NMEs NMEs Additional indications NMEs AZD9977 Imfinzi + Lynparza BAYOU roxadustat# moxetumomab# PLAIT [US] 1 MCR CV disease PD-L1 mAb + PARP inhibitor 1st-line unresectable HIFPH anaemia in myelodys

6. Slide 6: Q1 2018 New Molecular Entity (NME) Pipeline

   Q1 2018 New Molecular Entity (NME)1 Pipeline Phase I Phase II Phase III 31 New Molecular Entities 21 New Molecular Entities 8 New Molecular Entities Small molecule Large molecule Small molecule Large molecule Small molecule Large molecule AZD0156 AZD4831 MEDI0562# adavosertib# (AZD1775)+chemotherapy

7. Slide 7: Q1 2018 Lifecycle Management (LCM) Pipeline

   Q1 2018 Lifecycle Management (LCM)1 Pipeline 1 Includes significant LCM projects and parallel indications for assets in P3 or beyond. Excludes LCM projects already launched in a major market # Partnered and/or in collaboration; ¶ Registrational P2/3 study Oncology Cardiovascular, Renal & Metabolism

8. Slide 8: Q1 2018 Lifecycle Management (LCM) Pipeline

   Q1 2018 Lifecycle Management (LCM)1 Pipeline 1 Includes significant LCM projects and parallel indications for assets in P3 or beyond. Excludes LCM projects already launched in a major market # Partnered and/or in collaboration; ¶ Registrational P2/3 study Oncology Cardiovascular, Renal & Metabolism

9. Slide 9: Approved medicines

   AstraZeneca Approved medicines

10. Slide 10: Lynparza: ovarian cancer and other cancers

    Approved medicines Oncology Late-stage development Lynparza (PARP inhibitor) Early development - IMED Early development - MedImmune Ovarian cancer and other cancers Trial Population Patients Design Endpoints Status CVRM Phase III Platinum-sensitive recurrent 295 • Arm 1: Lynparza tablets 300mg BID a

11. Slide 11: Lynparza: breast cancer and other cancers

    Approved medicines Oncology Late-stage development Lynparza (PARP inhibitor) Early development - IMED Early development - MedImmune Breast cancer and other cancers Trial Population Patients Design Endpoints Status CVRM Phase III BRCAm metastatic breast 302 • Arm 1: Lynparza 300mg BiD, continuous to

12. Slide 12: Tagrisso: non-small cell lung cancer

    Approved medicines Oncology Late-stage development Tagrisso (Highly-selective, irreversible EGFRi) Early development - IMED Early development - MedImmune Non-small cell lung cancer (NSCLC) Trial Population Patients Design Endpoints Status CVRM Phase III Advanced EGFRm NSCLC 410 • Arm 1: Tagrisso 80m

13. Slide 13: Tagrisso: non-small cell lung cancer

    Approved medicines Oncology Late-stage development Tagrisso (Highly-selective, irreversible EGFRi) Early development - IMED Early development - MedImmune Non-small cell lung cancer (NSCLC) Trial Population Patients Design Endpoints Status CVRM Phase Ib Advanced EGFRm TKI failure 308 • Arm 1: Tagriss

14. Slide 14: Imfinzi: non-small cell lung cancer

    Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune Non-small cell lung cancer (NSCLC) Trial Population Patients Design Endpoints Status CVRM Phase III Adjuvant NSCLC patients 1,100 • Arm 1: Imfinzi mg/kg IV Q4W x 12m • Primar

15. Slide 15: Imfinzi: other cancers

    Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune Other cancers Trial Population Patients Design Endpoints Status CVRM Phase I Solid tumours 108 • Dose Escalation: N=36, three cohorts receiving Treatment A • Safety and Toler

16. Slide 16: Imfinzi + tremelimumab: NSCLC and other cancers

    Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune + tremelimumab (CTLA-4 mAb) Non-small cell lung cancer (NSCLC) and other cancers CVRM Trial Population Patients Design Endpoints Status Phase III Stage IIIB-IV 3L NSCLC 480 •

17. Slide 17: Imfinzi + tremelimumab: other cancers

    Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune + tremelimumab (CTLA-4 mAb) Other cancers CVRM Trial Population Patients Design Endpoints Status Phase III Advanced Solid Malignancies 1,200 • Arm 1: Imfinzi • Primary endpoi

18. Slide 18: Calquence: blood cancers

    Approved medicines Oncology Late-stage development Calquence (BTK inhibitor) Early development - IMED Early development - MedImmune Blood cancers Trial Population Patients Design Endpoint(s) Status CVRM Phase III Relapsed/refractory chronic 533 • Arm A: Calquence • Primary endpoint: PFS • FPCD: Q2 2

19. Slide 19: Calquence: blood cancers

    Approved medicines Oncology Late-stage development Calquence (BTK inhibitor) Early development - IMED Early development - MedImmune Blood cancers Trial Population Patients Design Endpoint(s) Status CVRM Phase I/II B-Cell Malignancies 126 Dose escalation and expansion trial of the combination of • Sa

20. Slide 20: Calquence: blood cancers

    Approved medicines Oncology Late-stage development Calquence (BTK inhibitor) Early development - IMED Early development - MedImmune Blood cancers Trial Population Patients Design Endpoint(s) Status CVRM Phase I Japanese Adults with 28 • Calquence monotherapy • Safety • FPCD: Q2 2017 Advanced B-cell

21. Slide 21: Calquence: other cancers

    Approved medicines Oncology Late-stage development Calquence (BTK inhibitor) Early development - IMED Early development - MedImmune Other cancers Trial Population Patients Design Endpoint(s) Status CVRM Phase II ≥ 2L advanced or metastatic 74 • Arm A: pembrolizumab • ORR • FPCD: Q2 2015 ACE-ST-006 H

22. Slide 22: Brilinta: cardiovascular risk reduction

    Approved medicines Oncology Late-stage development Brilinta (ADP receptor antagonist) Early development - IMED Early development - MedImmune Cardiovascular risk reduction Trial Population Patients Design Endpoints (primary) Status CVRM Phase III Patients with type-2 diabetes 19,000 • Arm 1: Brilinta

23. Slide 23: Farxiga: diabetes

    Approved medicines Oncology Late-stage development Farxiga (SGLT2 inhibitor) Early development - IMED Early development - MedImmune Diabetes Trial Population Patients Design Endpoints Status CVRM Phase III/IV Type-2 diabetes 17,160 • Arm 1: Farxiga 10mg QD + SoC therapy QD • Primary endpoint: Time t

24. Slide 24: Farxiga: diabetes / cardiovascular risk reduction

    Approved medicines Oncology Late-stage development Farxiga (SGLT2 inhibitor) Early development - IMED Early development - MedImmune Diabetes / cardiovascular risk reduction Trial Population Patients Design Endpoints Status CVRM Phase III Patients With Chronic Heart 4,500 • Arm 1: Farxiga 10mg or 5 m

25. Slide 25: Qtern: type-2 diabetes

    Approved medicines Oncology Late-stage development Qtern (saxagliptin/dapagliflozin) (DPP-4/SGLT2 inhibitor) Early development - IMED Early development - MedImmune Type-2 diabetes Trial Population Patients Design Endpoints Status CVRM Phase III Type-2 diabetes 420 • Arm 1: saxagliptin 5mg + dapaglif

26. Slide 26: Bydureon: type-2 diabetes

    Approved medicines Oncology Late-stage development Bydureon (GLP-1 receptor agonist) Early development - IMED Early development - MedImmune Type-2 diabetes Trial Population Patients Design Endpoints Status CVRM Phase IV Type-2 diabetes 14,742 • Arm 1: Bydureon once weekly 2mg SC • Primary endpoint:

27. Slide 27: Epanova: hypertriglyceridaemia

    Approved medicines Oncology Late-stage development Epanova (omega-3 carboxylic acids) Early development - IMED Early development - MedImmune Hypertriglyceridaemia Trial Population Patients Design Endpoints Status CVRM Phase III Patients with 13,000 • Arm 1: Epanova 4g QD + statin • Primary endpoint:

28. Slide 28: Lokelma: hyperkalaemia

    Approved medicines Oncology Late-stage development Lokelma (ZS-9, sodium zirconium cyclosilicate) Early development - IMED Early development - MedImmune Hyperkalaemia Trial Phase II Population Hyperkalaemia and moderate chronic kidney disease (CKD) Patients 90 Design • Arm 1: Escalating TID doses (0

29. Slide 29: Lokelma: hyperkalaemia

    Approved medicines Oncology Late-stage development Lokelma (ZS-9, sodium zirconium cyclosilicate) Early development - IMED Early development - MedImmune Hyperkalaemia Trial Population Patients Design Endpoints Status CVRM Phase I Healthy Subjects 22 Arm 1: Open-label ZS 5g QD for 4 days • Primary en

30. Slide 30: Eklira/Tudorza: COPD

    Approved medicines Oncology Late-stage development Eklira/Tudorza (LAMA) Early development - IMED Early development - MedImmune Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVRM Phase IV Patients with COPD 224 • Arm 1: Eklira/Tudorza 400μg • Primary

31. Slide 31: Eklira/Tudorza: COPD

    Approved medicines Oncology Late-stage development Eklira/Tudorza (LAMA) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Trial Population Number of patients Design Endpoints Status CVRM Phase I Healthy Chinese 18 Open-label, 2-period ascending dose

32. Slide 32: Duaklir Genuair: COPD

    Approved medicines Oncology Late-stage development Duaklir Genuair (LAMA/LABA) Early development - IMED Early development - MedImmune Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVRM Phase IIb Patients with moderate COPD 120 • Arm 1: Duaklir Genuair

33. Slide 33: Duaklir Genuair: COPD

    Approved medicines Oncology Late-stage development Duaklir Genuair (LAMA/LABA) Early development - IMED Early development - MedImmune Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVRM Phase IIa Chinese patients with stable 20 • Single and multiple tw

34. Slide 34: Bevespi Aerosphere: COPD

    Approved medicines Oncology Late-stage development Bevespi Aerosphere (LAMA/LABA) Early development - IMED Early development - MedImmune Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVRM Phase III Moderate to very severe 2,103 Treatment (24-week Trea

35. Slide 35: Bevespi Aerosphere: COPD

    Approved medicines Oncology Late-stage development Bevespi Aerosphere (LAMA/LABA) Early development - IMED Early development - MedImmune Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design (G = glycopyrronium, F = formoterol fumarate) Endpoints Status CVRM Phase III Moderat

36. Slide 36: Daliresp/Daxas: COPD

    Approved medicines Oncology Late-stage development Daliresp/Daxas (oral PDE4 inhibitor) Early development - IMED Early development - MedImmune Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVRM Phase IV COPD 2,354 • 52W, randomised, DB with Daliresp 5

37. Slide 37: Fasenra: severe, uncontrolled asthma

    Approved medicines Oncology Late-stage development Fasenra (IL-5R mAb) Early development - IMED Early development - MedImmune Severe, uncontrolled asthma Trial Population Patients Design Endpoints Status CVRM Phase III Severe, uncontrolled asthma, 1,026 HD + ~200 MD • Arm 1: 30mg Q8w SC • Primary en

38. Slide 38: Fasenra: severe, uncontrolled asthma

    Approved medicines Oncology Late-stage development Fasenra (IL-5R mAb) Early development - IMED Early development - MedImmune Severe, uncontrolled asthma Trial Population Patients Design Endpoints Status CVRM Phase III Asthmatic with FEV1 (50-90% 200 • Arm 1: 30mg Q4W SC • Primary endpoint: Pulmonar

39. Slide 39: Fasenra: severe, uncontrolled asthma

    Approved medicines Oncology Late-stage development Fasenra (IL-5R mAb) Early development - IMED Early development - MedImmune Severe, uncontrolled asthma Trial Population Patients Design Endpoints Status CVRM Phase III Severe asthma 230 • Arm 1: 30mg Q4W SC • Primary endpoint: Onset and • FPCD: Q4 2

40. Slide 40: Fasenra: COPD

    Approved medicines Oncology Late-stage development Fasenra (IL-5R mAb) Early development - IMED Early development - MedImmune Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVRM Phase III Moderate to very severe 2,168 • Arm 1: 10mg Q8W SC • Primary end

41. Slide 41: Fasenra: nasal polyposis

    Approved medicines Oncology Late-stage development Fasenra (IL-5R mAb) Early development - IMED Early development - MedImmune Nasal Polyposis Trial Population Patients Design Endpoints Status CVRM Phase III Patients with severe bilateral 400 • Arm 1: 30mg Q8W SC • Primary endpoint: Effect of Fasenra

42. Slide 42: Calquence: rheumatoid arthritis

    Approved medicines Oncology Late-stage development Calquence (BTK inhibitor) Early development - IMED Early development - MedImmune Rheumatoid arthritis Trial Population Patients Design Endpoint(s) Status CVRM Phase II Rheumatoid Arthritis 31 • Arm A: Calquence + methotrexate Disease Activity Score

43. Slide 43: Late-stage pipeline

    AstraZeneca Late-stage pipeline

44. Slide 44: Moxetumomab pasudotox: blood cancer

    Approved medicines Oncology Late-stage development Moxetumomab pasudotox (CD22 mAb) Early development - IMED Early development - MedImmune Blood cancer Trial Population Patients Design Endpoints Status CVRM Phase III Adults with relapsed or 77 • Multicentre, single-arm, open-label Phase III trial •

45. Slide 45: Selumetinib: thyroid cancer and other cancers

    Approved medicines Oncology Late-stage development Selumetinib (MEK inhibitor) Early development - IMED Early development - MedImmune Thyroid cancer and other cancers Trial Population Patients Design Endpoints Status CVRM Phase III Differentiated thyroid cancer 304 • Arm 1: selumetinib 75mg BiD 5 we

46. Slide 46: Savolitinib: papillary renal cell and other cancers

    Approved medicines Oncology Late-stage development Savolitinib (MET inhibitor) Early development - IMED Early development - MedImmune Papillary renal cell and other cancers Trial Population Patients Design Endpoints Status CVRM Phase III MET-Driven, Papillary renal 180 • Arm 1: savolitinib 600mg QD

47. Slide 47: Cediranib: ovarian cancer

    Approved medicines Oncology Late-stage development Cediranib (VEGF receptor inhibitor) Early development - IMED Early development - MedImmune Ovarian cancer Trial Population Patients Design Endpoints Status CVRM Phase IIb Platinum resistant recurrent 100 • Cediranib 30 mg + Lynparza 200 mg bd • ORR

48. Slide 48: Roxadustat: anaemia

    Approved medicines Oncology Late-stage development Roxadustat (HIF-PHI inhibitor) Early development - IMED Early development - MedImmune Anaemia Trial Population Patients Design Endpoints Status CVRM Phase III ANDES Anaemia in CKD patients not 900 • Arm 1: roxadustat Primary endpoint: Haemoglobin re

49. Slide 49: Roxadustat: anaemia

    Approved medicines Oncology Late-stage development Roxadustat (HIF-PHI inhibitor) Early development - IMED Early development - MedImmune Anaemia Trial Population Patients Design Endpoints Status CVRM Phase III HIMALAYAS Anaemia in newly initiated 750 • Arm 1: roxadustat Primary endpoint: Haemoglobin

50. Slide 50: PT010: COPD

    Approved medicines Oncology Late-stage development PT010 (LAMA/LABA/ICS) Early development - IMED Early development - MedImmune Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVRM Phase III Moderate to very severe 500 Treatments (52-week Treatment Peri

51. Slide 51: Tezepelumab: severe, uncontrolled asthma

    Approved medicines Oncology Late-stage development Tezepelumab (TSLP mAb) Early development - IMED Early development - MedImmune Severe, uncontrolled asthma Trial Population Patients Design Endpoints Status CVRM Phase III Severe asthma 1,060 • Arm 1: tezepelumab SC • Primary endpoint: Annual asthma

52. Slide 52: Anifrolumab: SLE / lupus nephritis

    Approved medicines Oncology Late-stage development Anifrolumab (type I IFN receptor mAb) Early development - IMED Early development - MedImmune Systemic lupus erythematosus (SLE) / Lupus nephritis (LN) Trial Population Patients Design Endpoints Status CVRM Phase III Moderate to severe SLE 450 • Arm

53. Slide 53: Lanabecestat: Alzheimer's disease

    Approved medicines Oncology Late-stage development Lanabecestat (BACE inhibitor) Early development - IMED Early development - MedImmune Alzheimer’s disease Trial Population Patients Design Endpoints Status CVRM Phase III Early Alzheimer’s disease 2,218 • Arm 1: lanabecestat 20mg once daily • Primary

54. Slide 54: Early development - IMED

    AstraZeneca Early development - IMED (AstraZeneca Research and Early Development)

55. Slide 55: Capivasertib (AZD5363): cancer

    Approved medicines Oncology Late-stage development Capivasertib (AZD5363, AKT inhibitor) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Breast and gynaecological 12-24 per arm (Parts E AZD5363 400mg BD 4 days on 3 days off

56. Slide 56: Vistusertib: cancer

    Approved medicines Oncology Late-stage development Vistusertib (mTORC1/2 inhibitor) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase II 2L oestrogen-receptor positive 316 • Arm 1: Faslodex • Primary endpoint: PFS • FPCD: Q2 20

57. Slide 57: AZD0156: cancer

    Approved medicines Oncology Late-stage development AZD0156 (ATM inhibitor) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Solid tumours 130 • Arm 1: AZD0156 + Lynparza • Safety, tolerability, PK and efficacy • FPCD: Q4 201

58. Slide 58: AZD1390: cancer

    Approved medicines Oncology Late-stage development AZD1390 (ATM inhibitor, blood brain barrier) Early development - IMED Early development - MedImmune Cancer Trial Population Subjects Design Endpoints Status CVRM Phase I Healthy Volunteers 8 • Positron-Emission Tomography (PET) Study • Brain distrib

59. Slide 59: AZD1775: ovarian, breast, lung cancer

    Approved medicines Oncology Late-stage development AZD1775 (WEE-1 inhibitor) Early development - IMED Early development - MedImmune Ovarian cancer, triple-negative breast cancer, small cell lung cancer (SCLC) Trial Population Patients Design Endpoints Status CVRM Phase II Platinum-resistant (PR) 97

60. Slide 60: AZD1775: ovarian, breast, lung cancer

    Approved medicines Oncology Late-stage development AZD1775 (WEE-1 inhibitor) Early development - IMED Early development - MedImmune Ovarian cancer, triple-negative breast cancer, small cell lung cancer (SCLC) Trial Population Patients Design Endpoints Status CVRM Phase I Advanced solid tumours 24 Op

61. Slide 61: AZD2811: cancer

    Approved medicines Oncology Late-stage development AZD2811 (aurora kinase B inhibitor) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Solid tumours 72 • Arm 1: AZD2811 dose escalation • Safety and tolerability • FPCD: Q4 2

62. Slide 62: AZD4547: cancer

    Approved medicines Oncology Late-stage development AZD4547 (FGFR inhibitor) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase II Female ER+ breast cancer 40 • Part A: AZD4547 in ascending multiple doses in combination • Part A:

63. Slide 63: AZD4573: cancer

    Approved medicines Oncology Late-stage development AZD4573 (CDK9 inhibitor) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Relapsed/refractory 42 Dose Escalation in relapsed/refractory haematological • Primary-Safety/PK; s

64. Slide 64: AZD4635: cancer

    Approved medicines Oncology Late-stage development AZD4635 (A2AR inhibitor) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Phase Ia: patients with 36 (estimated) • Phase 1a: dose escalation to determine the Maximum Primary

65. Slide 65: AZD4785: cancer

    Approved medicines Oncology Late-stage development AZD4785 (KRAS antisense oligonucleotide) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Phase Ia: patients with 30 (estimated) • Phase Ia: dose escalation to determine the

66. Slide 66: AZD5069: cancer

    Approved medicines Oncology Late-stage development AZD5069 (CXCR2 antagonist) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase Ib/II Squamous Cell Carcinoma of 465 Dose Escalation advanced solid and blood cancers • Safety/Effi

67. Slide 67: AZD5153: cancer

    Approved medicines Oncology Late-stage development AZD5153 (BRD4 inhibitor) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I/Ib Relapsed/refractory solid 54 Dose Escalation advanced solid and lymphomas • Primary-Safety/ seco

68. Slide 68: AZD5991: cancer

    Approved medicines Oncology Late-stage development AZD5991 (MCL1 inhibitor) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Relapsed/refractory 30 Dose Escalation in relapsed/refractory haematological • Primary-Safety/ seco

69. Slide 69: AZD6738: cancer

    Approved medicines Oncology Late-stage development AZD6738 (ATR inhibitor) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Solid tumours 160 • Arm 1: AZD6738 + carboplatin • Safety and tolerability • FPCD: Q4 2014 • Arm 2:

70. Slide 70: AZD8186: cancer

    Approved medicines Oncology Late-stage development AZD8186 (PI3Kb/d inhibitor) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Advanced Castrate Resistant 153 • Part A: AZD8186 monotherapy in ascending intermittent doses •

71. Slide 71: AZD9150: cancer

    Approved medicines Oncology Late-stage development AZD9150 (STAT3 inhibitor) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase Ib/II Squamous Cell Carcinoma of 405 Dose Escalation advanced solid and blood cancers • Safety/Effic

72. Slide 72: AZD9496: breast cancer

    Approved medicines Oncology Late-stage development AZD9496 (selective estrogen receptor degrader) Early development - IMED Early development - MedImmune Breast cancer Trial Population Patients Design Endpoints Status CVRM Phase I ER+ Breast Cancer ~50 • This is an open label randomised multicentre p

73. Slide 73: Verinurad: chronic kidney disease

    Approved medicines Oncology Late-stage development Verinurad (RDEA3170, URAT1 inhibitor) Early development - IMED Early development - MedImmune Chronic kidney disease Trial Population Patients Design Endpoints Status CVRM Phase II CKD patients with 60 • Arm A: verinurad 9 mg and febuxostat 80 mg To

74. Slide 74: AZD4831 & AZD5718: cardiovascular disease

    Approved medicines Oncology Late-stage development AZD4831 & AZD5718 Early development - IMED Early development - MedImmune Cardiovascular disease Trial Population Patients Design Endpoints Status CVRM AZD4831 (MPO) Healthy subjects ~96 SAD trial (one trial site in Germany) • Safety and tolerability

75. Slide 75: AZD8601: cardiovascular disease

    Approved medicines Oncology Late-stage development AZD8601 (VEGF-A) Early development - IMED Early development - MedImmune Cardiovascular disease Trial Population Patients Design Endpoints Status CVRM Phase I Type 2 diabetic patients ~60 SAD trial (one trial site in Germany) • Safety and tolerabilit

76. Slide 76: AZD9977: heart failure

    Approved medicines Oncology Late-stage development AZD9977 Early development - IMED Early development - MedImmune Heart Failure with preserved Ejection Fraction Trial Population Patients Design Endpoints Status CVRM Phase I Healthy subjects 27 MAD Primary: • FPCD: Q1 2018 • Safety and tolerability N

77. Slide 77: Abediterol: asthma

    Approved medicines Oncology Late-stage development Abediterol (AZD0548, LABA) Early development - IMED Early development - MedImmune Asthma Trial Population Patients Design Endpoints Status CVRM Phase I Patients With Asthma on 12 A randomised, single-blind, placebo-controlled study to assess • To as

78. Slide 78: AZD1419: asthma

    Approved medicines Oncology Late-stage development AZD1419 (TLR9 agonist) Early development - IMED Early development - MedImmune Asthma Trial Population Patients Design Endpoints Status CVRM Phase IIa Adults with eosinophilic, 81 • Arm 1: AZD1419, once-weekly adaptive dosing (4mg, 1mg, • Time to los

79. Slide 79: AZD5634: cystic fibrosis

    Approved medicines Oncology Late-stage development AZD5634 (epithelial NaC inhibitor) Early development - IMED Early development - MedImmune Cystic fibrosis Trial Population Patients Design Endpoints Status CVRM Phase I Healthy subjects Part A: 57 SAD. Primary Endpoint • FPCD: Q1 2016 Part B: 6 A Ph

80. Slide 80: AZD7594: asthma/COPD

    Approved medicines Oncology Late-stage development AZD7594 (inhaled SGRM) Early development - IMED Early development - MedImmune Asthma/chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVRM Phase II Patients with mild to moderate 48 A randomised, double

81. Slide 81: AZD7594: asthma/COPD

    Approved medicines Oncology Late-stage development AZD7594 (inhaled SGRM) Early development - IMED Early development - MedImmune Asthma/chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVRM Phase I Healthy subjects 18 A randomised open label three-way cr

82. Slide 82: AZD8871: COPD

    Approved medicines Oncology Late-stage development AZD8871 (MABA2) Early development - IMED Early development - MedImmune Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVRM Phase IIa Moderate to severe COPD 42 Comprises 3 treatment periods of 14 days

83. Slide 83: AZD9567: respiratory

    Approved medicines Oncology Late-stage development AZD9567 (oSGRM) Early development - IMED Early development - MedImmune Respiratory Trial Population Patients Design Endpoints Status CVRM Phase I Healthy subjects 71 MAD trial with a total of 6 dose levels of AZD9567: 10 mg, 20mg, Primary Endpoint:

84. Slide 84: AZD0284: plaque psoriasis

    Approved medicines Oncology Late-stage development AZD0284 (RORγ inverse agonist) Early development - IMED Early development - MedImmune Plaque psoriasis vulgaris Trial Population Patients Design Endpoints Status CVRM Phase I Healthy subjects 80 Part 1 (SAD) • Safety and tolerability and PK followin

85. Slide 85: Early development - MedImmune

    MedImmune Early development - MedImmune Research & Early Development

86. Slide 86: Imfinzi: cancer

    Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune Cancer Trial Compound Population Patients Design Endpoints Status CVRM Phase I/II Imfinzi Solid tumours 1,022 • Dose Escalation: 5 cohorts at Q2W and 1 cohort at Q3W • Safety

87. Slide 87: Imfinzi + tremelimumab: cancer

    Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune + tremelimumab (CTLA-4 mAb) Cancer CVRM Trial Population Patients Design Endpoints Status Phase Ib/II Gastric or GEJ 236 • Arm A: Imfinzi + tremelimumab 2L • Primary endpoint

88. Slide 88: Imfinzi + Iressa: NSCLC

    Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune + Iressa (gefitinib) Non-small cell lung cancer (NSCLC) CVRM Trial Population Patients Design Endpoints Status Phase I NSCLC 56 Escalation phase Primary endpoints: • FPCD: Q2

89. Slide 89: Imfinzi + MEDI0680: cancer

    Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune + MEDI0680 (PD-1 mAb) Cancer CVRM Trial Population Patients Design Endpoints Status Phase I Advanced malignancies 96 Dose-escalation phase Primary endpoints: • FPCD: Q2 2014

90. Slide 90: Imfinzi + dabrafenib / trametinib: melanoma

    Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) + dabrafenib Early development - IMED Early development - MedImmune (BRAF inhibitor) / trametinib (MEK inhibitor) Melanoma CVRM Trial Population Patients Design Endpoints Status Phase I/II Metastatic or unresectable 68 Dose Escal

91. Slide 91: Imfinzi + oleclumab: cancer

    Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) + Early development - IMED Early development - MedImmune oleclumab (MEDI9447, CD73 mAb) Cancer CVRM Trial Population Patients Design Endpoints Status Phase I Advanced malignancies 188 Dose-escalation phase Primary endpoints: • FP

92. Slide 92: Imfinzi + monalizumab: cancer

    Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune + monalizumab (NKG2a mAb) Cancer CVRM Trial Population Patients Design Endpoints Status Phase I Advanced solid tumours 280 Escalation phase Primary endpoints: • FPCD: Q2 2016

93. Slide 93: MEDI0457 + Imfinzi: SCCHN

    Approved medicines Oncology Late-stage development MEDI0457 Early development - IMED Early development - MedImmune + Imfinzi (PD-L1 mAb) Squamous cell carcinoma of the Head and Neck (SCCHN) CVRM Trial Population Patients Design Endpoints Status Phase Ib/IIa Human papillomavirus (HPV) 50 Multi-centre

94. Slide 94: MEDI0562: cancer

    Approved medicines Oncology Late-stage development MEDI0562 (OX40 mAb) Early development - IMED Early development - MedImmune MEDI0562 (OX40 mAb) + Imfinzi (PD-L1 mAb) or tremelimumab (CTLA-4 mAb) CVRM Cancer Trial Population Patients Design Endpoints Status Respiratory Phase I Advanced malignancies

95. Slide 95: MEDI1873: cancer

    Approved medicines Oncology Late-stage development MEDI1873 (GITR agonist) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Adult subjects with select 51 Dose-escalation phase Primary endpoints: • FPCD: Q4 2015 advanced soli

96. Slide 96: MEDI2228: cancer

    Approved medicines Oncology Late-stage development MEDI2228 Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Relapsed/Refractory Multiple 129 First-time-in-human Phase 1, multi-centre, open-label, single-arm, Primary endpoin

97. Slide 97: MEDI3726: cancer

    Approved medicines Oncology Late-stage development MEDI3726 (PSMA antibody drug conjugate) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I/Ib Subjects with metastatic 224 Open-label, Dose-escalation and Dose-expansion Prima

98. Slide 98: MEDI4276: cancer

    Approved medicines Oncology Late-stage development MEDI4276 (HER2 ADC mAb) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Advanced HER2+ metastatic Dose escalation • First-time-in-human Phase 1, multi-centre, open-label, s

99. Slide 99: MEDI5083 + Imfinzi: cancer

    Approved medicines Oncology Late-stage development MEDI5083 + Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Advanced Solid Tumours 204 Dose-escalation phase Primary endpoints: • FPCD: Q1 2017 • Part 1:

100. Slide 100: MEDI7247: cancer

     Approved medicines Oncology Late-stage development MEDI7247 (PBD ADC mAb) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Relapsed/Refractory 228 First-time-in-human Phase 1, multi-centre, open-label, single-arm, • Primary

101. Slide 101: MEDI9197: cancer

     Approved medicines Oncology Late-stage development MEDI9197 (TLR7/8 agonist) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Advanced solid tumour 135 Dose-escalation phase Primary endpoints: • FPCD: Q4 2015 malignancies re

102. Slide 102: MEDI0382: diabetes

     Approved medicines Oncology Late-stage development MEDI0382 (GLP-1-glucagon agonist) Early development - IMED Early development - MedImmune Diabetes Trial Population Patients Design Endpoints Status CVRM Phase I Healthy adult subjects 64 • SAD SC administration • Safety profile in terms of adverse e

103. Slide 103: MEDI0382: diabetes

     Approved medicines Oncology Late-stage development MEDI0382 (GLP-1-glucagon agonist) Early development - IMED Early development - MedImmune Diabetes Trial Population Patients Design Endpoints Status CVRM Phase I Healthy adult subjects 22 • Open label, one sequence, cross-over • Effect of MEDI0382 on

104. Slide 104: MEDI7219: diabetes

     Approved medicines Oncology Late-stage development MEDI7219 Early development - IMED Early development - MedImmune Diabetes Trial Population Patients Design Endpoints Status CVRM Phase I Healthy Volunteers 106 • 4 part study • Safety and tolerability • FPCD: Q1 2018 • Part A : SAD • Pharmacokinetics

105. Slide 105: Biologics: cardiovascular & metabolic diseases

     Approved medicines Oncology Late-stage development Biologics Early development - IMED Early development - MedImmune Cardiovascular & metabolic diseases Trial Compound Population Patients Design Endpoints Status CVRM Phase IIa rhLCAT Adults with stable 56 • SAD in stable CAD patients • Safety profile

106. Slide 106: MEDI3506: COPD

     Approved medicines Oncology Late-stage development MEDI3506 (IL-33 mAb) Early development - IMED Early development - MedImmune COPD Trial Population Patients Design Endpoints Status CVRM Phase I (Combined SAD / SAD: Healthy subjects with SAD: 56 SAD: • Safety and tolerability • FPCD: Q2 2017 MAD) mi

107. Slide 107: MEDI7836: asthma

     Approved medicines Oncology Late-stage development MEDI7836 (IL-13 mAb) Early development - IMED Early development - MedImmune Asthma Trial Population Patients Design Endpoints Status CVRM Phase I Healthy subjects 32 • Arm 1: 30mg MEDI7836 (6) or placebo (2) as a single • Safety and tolerability • F

108. Slide 108: MEDI0700: systemic lupus erythematosus

     Approved medicines Oncology Late-stage development MEDI0700 - AMG 570 (Anti-B7RP-1 mAb/BAFF) Early development - IMED Early development - MedImmune Systemic lupus erythematosus (SLE) Trial Population Patients Design Endpoints Status CVRM Phase Ia Healthy subjects 48 Single Ascending Dose • Safety an

109. Slide 109: MEDI1814: Alzheimer's disease

     Approved medicines Oncology Late-stage development MEDI1814 (amyloid beta mAb) Early development - IMED Early development - MedImmune Alzheimer’s disease Trial Population Patients Design Endpoints Status CVRM Phase I Alzheimer’s disease & healthy 121 • SAD & MAD • Safety, tolerability • FPCD: Q2 201

110. Slide 110: MEDI5872: systemic lupus erythematosus

     Approved medicines Oncology Late-stage development MEDI5872 - AMG 557 (B7RP-1 mAb) Early development - IMED Early development - MedImmune Systemic lupus erythematosus (SLE) Trial Population Patients Design Endpoints Status CVRM Phase IIa Primary Sjögren's syndrome 42 • Arm 1: MEDI5872 210mg SC QW fo

111. Slide 111: MEDI7352: osteoarthritis pain

     Approved medicines Oncology Late-stage development MEDI7352 (NGF TNF bispecific) Early development - IMED Early development - MedImmune Osteoarthritis pain Trial Population Patients Design Endpoints Status CVRM Phase I Painful osteoarthritis of the knee 160 • SAD & MAD • Safety, tolerability, PK, PD

112. Slide 112: Other biologics: infections

     Approved medicines Oncology Late-stage development Other biologics Early development - IMED Early development - MedImmune Infections Trial Compound Population Patients Design Endpoints Status CVRM Phase II Anti-Staph AT Intubated ICU 285 • Placebo-controlled, single-dose, dose-ranging • Efficacy and

113. Slide 113: Clinical trials appendix Q1 2018 Results update

     Clinical trials appendix Q1 2018 Results update

AstraZeneca — Q1 2018 Earnings Presentation on 6ix