Astrazeneca Plc · LSE:AZN

Astrazeneca — Q3 2016 Earnings Presentation

101 slides from Astrazeneca's earnings presentation, 2016

1. Slide 1: Clinical trials appendix: Year-To-Date and Q3 2016 Results update

   Clinical trials appendix Year-To-Date and Q3 2016 Results update

2. Slide 2: Information about AstraZeneca clinical trials in Phases I-IV

   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 30 September 20

3. Slide 3: List of abbreviations

   List of abbreviations AE Adverse Event LCM Life-Cycle Management Q2W Quaque (every) Two Weeks AUC Area Under Curve LPCD Last Patient Commenced Dosing Q3W Quaque (every) Three Weeks BID Bis In Die (two times a day) MAD Multiple Ascending Dose Q4W Quaque (every) Four Weeks CE Clinically Evaluable MDI

4. Slide 4: Movement since the last update

   Movement since the last update New to Phase I New to Phase II New to Pivotal Study New to Registration NMEs NMEs NMEs AZD4831 MEDI0382 ZS-9 [US] resubmission5 Myeloperoxidase Inhibitor GLP-1/glucagon diabetes/obesity potassium binder hyperkalaemia MEDI7734 MEDI5872# ILT7 myositis B7RP-1 mAb primary

5. Slide 5: New Molecular Entity (NME) Pipeline

   New Molecular Entity (NME)1 Pipeline Oncology Cardiovascular and metabolic disease Respiratory Other 1 Includes significant fixed-dose combination projects, and parallel indications that are in a separate therapy area (See LCM chart for other parallel indications and oncology combination projects) #

6. Slide 6: Lifecycle Management (LCM) Pipeline

   Lifecycle Management (LCM)1 Pipeline Oncology Cardiovascular and metabolic disease Respiratory Other 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

7. Slide 7: Approved medicines

   AstraZeneca Approved medicines

8. Slide 8: Lynparza (PARP inhibitor) Ovarian cancer and other solid tumours

   Approved medicines Late-stage development Lynparza (PARP inhibitor) Early development - IMED Early development - MedImmune Ovarian cancer and other solid tumours Trial phase Patient population Number of patients Design Endpoints Status Phase III PSR BRCAm ovarian cancer N = 264 • Arm 1: Lynparza tab

9. Slide 9: Lynparza (PARP inhibitor) Solid tumours

   Approved medicines Late-stage development Lynparza (PARP inhibitor) Early development - IMED Early development - MedImmune Solid tumours Trial phase Patient population Number of patients Design Endpoints Status Phase III BRCAm metastatic breast N = 310 • Arm 1: Lynparza 300mg BiD, continuous to prog

10. Slide 10: Tagrisso Non-small cell lung cancer

    Approved medicines Late-stage development Tagrisso (Highly-selective, irreversible EGFR TKI) Early development - IMED Early development - MedImmune Non-small cell lung cancer (NSCLC) Trial phase Patient population Number of patients Design Endpoints Status Phase III Advanced EGFRm NSCLC N = 410 • Ar

11. Slide 11: Tagrisso Non-small cell lung cancer

    Approved medicines Late-stage development Tagrisso (Highly-selective, irreversible EGFR TKI) Early development - IMED Early development - MedImmune Non-small cell lung cancer (NSCLC) Trial phase Patient population Number of patients Design Endpoints Status Phase Ib Advanced EGFRm NSCLC TKI N ~90 • A

12. Slide 12: Brilinta (ADP receptor antagonist) Cardiovascular

    Approved medicines Late-stage development Brilinta (ADP receptor antagonist) Early development - IMED Early development - MedImmune Cardiovascular Trial phase Patient population Number of patients Design Endpoints (primary) Status Phase III Patients with type-2 diabetes N = 19,000 • Arm 1: Brilinta

13. Slide 13: Farxiga (SGLT2 inhibitor) Type-2 diabetes

    Approved medicines Late-stage development Farxiga (SGLT2 inhibitor) Early development - IMED Early development - MedImmune Type-2 diabetes Trial phase Patient population Number of patients Design Endpoints Status Phase IV Japanese patients with type-2 N = 266 • Arm 1: Farxiga 5mg • Change from basel

14. Slide 14: Onglyza (DPP-4 inhibitor) Type-2 diabetes

    Approved medicines Late-stage development Onglyza (DPP-4 inhibitor) Early development - IMED Early development - MedImmune Type-2 diabetes Trial phase Patient population Number of patients Design Endpoints Status Phase III Type-2 diabetes N = 444 • Arm 1: Onglyza 5mg QD + insulin with or without met

15. Slide 15: Qtern Type-2 diabetes

    Approved medicines Late-stage development Qtern (saxagliptin/dapagliflozin) (DPP-4/SGLT2 inhibitor) Early development - IMED Early development - MedImmune Type-2 diabetes Trial phase Patient population Number of patients Design Endpoints Status Phase III Type-2 diabetes N = 420 • Arm 1: Saxagliptin

16. Slide 16: Bydureon (GLP-1 receptor agonist) Type-2 diabetes

    Approved medicines Late-stage development Bydureon (GLP-1 receptor agonist) Early development - IMED Early development - MedImmune Type-2 diabetes Trial phase Patient population Number of patients Design Endpoints Status Phase IV Type-2 diabetes N = 14,000 • Arm 1: Bydureon once weekly 2mg SC • Time

17. Slide 17: Epanova Hypertriglyceridaemia

    Approved medicines Late-stage development Epanova (omega-3 carboxylic acids) Early development - IMED Early development - MedImmune Hypertriglyceridaemia Trial phase Patient population Number of patients Design Endpoints Status Phase III Japanese patients with N = 375 • Epanova 2g and 4g vs. Placebo

18. Slide 18: Epanova Hypertriglyceridaemia

    Approved medicines Late-stage development Epanova (omega-3 carboxylic acids) Early development - IMED Early development - MedImmune Hypertriglyceridaemia Trial phase Patient population Number of patients Design Endpoints Status Phase I Healthy subjects N = 40 Part A • Arm 1: D1400147 4g • Rate and e

19. Slide 19: Symbicort (ICS/LABA) Mild asthma

    Approved medicines Late-stage development Symbicort (ICS/LABA) Early development - IMED Early development - MedImmune Mild asthma Trial phase Patient population Number of patients Design Endpoints Status Phase III Patients in need of GINA N = 3,850 • Arm 1: Symbicort Turbuhaler 160/4.5 μg 'as needed

20. Slide 20: Eklira/Tudorza (LAMA) COPD

    Approved medicines Late-stage development Eklira/Tudorza (LAMA) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Trial phase Patient population Number of patients Design Endpoints Status Phase IV Patients with COPD N = 224 • Arm 1: Aclidinium bromid

21. Slide 21: Duaklir (LAMA/LABA) COPD

    Approved medicines Late-stage development Duaklir (LAMA/LABA) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Trial phase Patient population Number of patients Design Endpoints Status Phase IIb Patients with N = 120 • Arm 1: Aclidinium/formoterol F

22. Slide 22: Bevespi Aerosphere (LAMA/LABA) COPD

    Approved medicines Late-stage development Bevespi Aerosphere (LAMA/LABA) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Trial phase Patient population Number of patients Design Endpoints Status Phase III Moderate to very severe N = 2,103 Treatment

23. Slide 23: Bevespi Aerosphere (LAMA/LABA) COPD

    Approved medicines Late-stage development Bevespi Aerosphere (LAMA/LABA) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Trial phase Patient population Number of patients Design Endpoints Status Phase IIIb Moderate to severe COPD N = 150 Treatment

24. Slide 24: Bevespi Aerosphere (LAMA/LABA) COPD

    Approved medicines Late-stage development Bevespi Aerosphere (LAMA/LABA) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Trial phase Patient population Number of patients Design (G = glycopyrronium, F = formoterol fumarate) Endpoints Status Phase I

25. Slide 25: Daliresp/Daxas (oral PDE4 inhibitor) COPD

    Approved medicines Late-stage development Daliresp/Daxas (oral PDE4 inhibitor) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Trial phase Patient population Number of patients Design Endpoints Status Phase IV COPD N = 2,354 • 52W, randomised, DB w

26. Slide 26: Late-stage pipeline

    AstraZeneca Late-stage pipeline

27. Slide 27: Durvalumab (MEDI4736; PD-L1 mAb) NSCLC

    Approved medicines Late-stage development Durvalumab (MEDI4736; PD-L1 mAb) Early development - IMED Early development - MedImmune Non-small cell lung cancer (NSCLC) Trial phase Patient population Number of patients Design Endpoints Status Phase III Adjuvant NSCLC patients N = 1,100 • Arm 1: MEDI4736

28. Slide 28: Durvalumab HNSCC and other solid tumours

    Approved medicines Late-stage development Durvalumab (MEDI4736; PD-L1 mAb) Early development - IMED Early development - MedImmune Squamous Cell Carcinoma of the Head & Neck (HNSCC) and other solid tumours Trial phase Patient population Number of patients Design Endpoints Status Phase II HNSCC N = 11

29. Slide 29: Durvalumab + tremelimumab Solid tumours

    Approved medicines Late-stage development Durvalumab (MEDI4736; PD-L1 mAb) Early development - IMED Early development - MedImmune + tremelimumab (CTLA-4 mAb) Solid tumours Trial phase Patient population Number of patients Design Endpoints Status Phase III Stage IIIB-IV 3L NSCLC N = 480 • Arm 1: durv

30. Slide 30: Durvalumab + tremelimumab Solid tumours

    Approved medicines Late-stage development Durvalumab (MEDI4736; PD-L1 mAb) Early development - IMED Early development - MedImmune + tremelimumab (CTLA-4 mAb) Solid tumours Trial phase Patient population Number of patients Design Endpoints Status Phase II HNSCC N = 240 • Arm 1: durvalumab • ORR • FPD

31. Slide 31: Acalabrutinib (ACP-196) Blood cancers

    Approved medicines Late-stage development Acalabrutinib (ACP-196) Early development - IMED Early development - MedImmune Blood cancers Trial phase Patient population Number of patients Design Endpoint(s) Status Phase III Relapsed/refractory CLL, high N = 500 • Arm A: acalabrutinib • PFS FPD: Q4 2015

32. Slide 32: Acalabrutinib (ACP-196) Blood cancers

    Approved medicines Late-stage development Acalabrutinib (ACP-196) Early development - IMED Early development - MedImmune Blood cancers Trial phase Patient population Number of patients Design Endpoint(s) Status Phase I/II Hematological Malignancies N=187 Acalabrutinib + pembrolizumab • Safety FPD: Q

33. Slide 33: Acalabrutinib (ACP-196) Solid tumours

    Approved medicines Late-stage development Acalabrutinib (ACP-196) Early development - IMED Early development - MedImmune Solid tumours Trial phase Patient population Number of patients Design Endpoint(s) Status Phase II ≥ 2L advanced or metastatic N = 78 • Arm A: pembrolizumab • ORR FPD: Q2 2015 ACE

34. Slide 34: Moxetumomab pasudotox (CD22 mAb) Blood cancers

    Approved medicines Late-stage development Moxetumomab pasudotox (CD22 mAb) Early development - IMED Early development - MedImmune Blood cancers Trial phase Patient population Number of patients Design Endpoints Status Phase III Adults with relapsed or N = 77 • Multicentre, single-arm, open-label tri

35. Slide 35: Selumetinib (AZD6244) Solid tumours

    Approved medicines Late-stage development Selumetinib (AZD6244) (MEK-inhibitor) Early development - IMED Early development - MedImmune Solid tumours Trial phase Patient population Number of patients Design Endpoints Status Phase III Differentiated thyroid cancer N = 304 • Arm 1: Selumetinib 75mg BiD

36. Slide 36: Roxadustat (HIF-PHI) CKD/ESRD

    Approved medicines Late-stage development Roxadustat (HIF-PHI) Early development - IMED Early development - MedImmune Chronic Kidney Disease/End Stage Renal Disease (CKD/ESRD) Trial phase Patient population Number of patients Design Endpoints Status Phase III ANDES Anaemia in CKD patients not N = 60

37. Slide 37: Roxadustat (HIF-PHI) CKD/ESRD

    Approved medicines Late-stage development Roxadustat (HIF-PHI) Early development - IMED Early development - MedImmune Chronic Kidney Disease/End Stage Renal Disease (CKD/ESRD) Trial phase Patient population Number of patients Design Endpoints Status Phase III HIMALAYAS Anaemia in newly initiated N =

38. Slide 38: Benralizumab (IL-5R mAb) Severe, uncontrolled asthma

    Approved medicines Late-stage development Benralizumab (IL-5R mAb) Early development - IMED Early development - MedImmune Severe, uncontrolled asthma Trial phase Patient population Number of patients Design Endpoints Status Phase III Severe, uncontrolled asthma, N = 1,026 HD + ~200 • Arm 1: 30mg Q8w

39. Slide 39: Benralizumab (IL-5R mAb) Severe, uncontrolled asthma

    Approved medicines Late-stage development Benralizumab (IL-5R mAb) Early development - IMED Early development - MedImmune Severe, uncontrolled asthma Trial phase Patient population Number of patients Design Endpoints Status Phase III Asthmatic with FEV1 (50-90% N = 200 • Arm 1: 30mg Q4W SC • Pulmona

40. Slide 40: Benralizumab (IL-5R mAb) Severe, uncontrolled asthma

    Approved medicines Late-stage development Benralizumab (IL-5R mAb) Early development - IMED Early development - MedImmune Severe, uncontrolled asthma Trial phase Patient population Number of patients Design Endpoints Status Phase III Severe asthma N = 230 • Arm1: 30mg Q4W SC • Onset and maintenance

41. Slide 41: Benralizumab (IL-5R mAb) COPD

    Approved medicines Late-stage development Benralizumab (IL-5R mAb) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Trial phase Patient population Number of patients Design Endpoints Status Phase III Moderate to very severe N = 2,168 • Arm 1: 10mg Q

42. Slide 42: Tralokinumab (IL-13 mAb) Severe, uncontrolled asthma

    Approved medicines Late-stage development Tralokinumab (IL-13 mAb) Early development - IMED Early development - MedImmune Severe, uncontrolled asthma Trial phase Patient population Number of patients Design Endpoints Status Phase III Adults with severe, N = 1,140 Cohort 1: Primary: • FPD: Q3 2014 ST

43. Slide 43: PT010 (LAMA/LABA/ICS) COPD & Asthma

    Approved medicines Late-stage development PT010 (LAMA/LABA/ICS) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) & Asthma Trial phase Patient population Number of patients Design Endpoints Status Phase III Moderate to very severe N = 500 Treatments

44. Slide 44: PT010 (LAMA/LABA/ICS) COPD & Asthma

    Approved medicines Late-stage development PT010 (LAMA/LABA/ICS) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) & Asthma Trial phase Patient population Number of patients Design Endpoints Status Phase II Adult mild to moderate N = 150 • Arm 1: BD M

45. Slide 45: PT010 (LAMA/LABA/ICS) COPD & Asthma

    Approved medicines Late-stage development PT010 (LAMA/LABA/ICS) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) & Asthma Trial phase Patient population Number of patients Design Endpoints Status Phase I Healthy subjects N = 60 • Arm 1: BGF MDI 320/

46. Slide 46: Anifrolumab Systemic Lupus Erythematosus

    Approved medicines Late-stage development Anifrolumab (type I IFN receptor mAb) Early development - IMED Early development - MedImmune Systemic Lupus Erythematosus (SLE) Trial phase Patient population Number of patients Design Endpoints Status Phase III Moderate to severe SLE N = 450 • Arm 1: 300mg

47. Slide 47: Anifrolumab Lupus Nephritis

    Approved medicines Late-stage development Anifrolumab (type I IFN receptor mAb) Early development - IMED Early development - MedImmune Lupus Nephritis (LN) Trial phase Patient population Number of patients Design Endpoints Status Phase II Active Proliferative LN (TULIP- N = 150 • Arm 1: 900 mg IV Q4

48. Slide 48: AZD3293 (BACE inhibitor) Alzheimer's disease

    Approved medicines Late-stage development AZD3293 (BACE inhibitor) Early development - IMED Early development - MedImmune Alzheimer’s disease Trial phase Patient population Number of patients Design Endpoints Status Phase III Early Alzheimer’s disease N = 2,202 • Arm 1: AZD3293 20mg once daily • Cha

49. Slide 49: Acalabrutinib (ACP-196) Rheumatoid Arthritis

    Approved medicines Late-stage development Acalabrutinib (ACP-196) Early development - IMED Early development - MedImmune Rheumatoid Arthritis Trial phase Patient population Number of patients Design Endpoint(s) Status Phase II Rheumatoid Arthritis N=31 • Arm A: Acalabrutinib + methotrexate Disease A

50. Slide 50: Early development - IMED

    AstraZeneca Early development - IMED

51. Slide 51: AZD0156 (ATM) Solid tumours

    Approved medicines Late-stage development AZD0156 (ATM) Early development - IMED Early development - MedImmune Solid tumours Trial phase Patient population Number of patients Design Endpoints Status Phase I Solid tumours N = 130 • Arm 1: AZD0156 + Lynparza • Safety, tolerability, pharmacokinetics •

52. Slide 52: AZD1775 (WEE-1)

    Approved medicines Late-stage development AZD1775 (WEE-1) Early development - IMED Early development - MedImmune Ovarian cancer, triple-negative breast cancer, Non-Small Cell Lung Cancer (NSCLC) Trial phase Patient population Number of patients Design Endpoints Status Phase II p53 mutant PSR ovarian

53. Slide 53: Vistusertib (AZD2014) (TORC 1/2)

    Approved medicines Late-stage development Vistusertib (AZD2014) (TORC 1/2) Early development - IMED Early development - MedImmune Breast and squamous Non-Small Cell Lung Cancer (NSCLC) Trial phase Patient population Number of patients Design Endpoints Status Phase IIa Relapsed or refractory N = 40 O

54. Slide 54: AZD2811 (AURN) Solid tumours

    Approved medicines Late-stage development AZD2811 (AURN) Early development - IMED Early development - MedImmune Solid tumours Trial phase Patient population Number of patients Design Endpoints Status Phase I Solid tumours N = 72 • Arm 1: AZD2811 dose escalation • Safety and tolerability • FPD: Q4 20

55. Slide 55: AZD3759 (EGFRm BBB)

    Approved medicines Late-stage development AZD3759 (EGFRm BBB) Early development - IMED Early development - MedImmune Non-Small Cell Lung Cancer (NSCLC) with lung and/or brain metastases Trial phase Patient population Number of patients Design Endpoints Status Phase I EGFRm+ NSCLC N = 47 • MAD • Safe

56. Slide 56: AZD4547 (FGFR) Solid tumours

    Approved medicines Late-stage development AZD4547 (FGFR) Early development - IMED Early development - MedImmune Solid tumours Trial phase Patient population Number of patients Design Endpoints Status Phase II Female ER+ breast cancer N = 40 • Part A: AZD4547 in ascending multiple doses in combinatio

57. Slide 57: AZD4635 (A2AR) Solid tumours and NSCLC

    Approved medicines Late-stage development AZD4635 (A2AR) Early development - IMED Early development - MedImmune Solid tumours and Non-Small Cell Lung Cancer (NSCLC) Trial phase Patient population Number of patients Design Endpoints Status Phase I Phase Ia: patients with N = 36 (estimated) • Phase 1a

58. Slide 58: AZD5069 (CXCR2) Solid tumours

    Approved medicines Late-stage development AZD5069 (CXCR2) Early development - IMED Early development - MedImmune Solid tumours Trial phase Patient population Number of patients Design Endpoints Status Phase Ib/II Squamous Cell Carcinoma of N = 147 Dose Escalation advanced solid and blood cancers • S

59. Slide 59: AZD5363 (AKT) Solid tumours

    Approved medicines Late-stage development AZD5363 (AKT) Early development - IMED Early development - MedImmune Solid tumours Trial phase Patient population Number of patients Design Endpoints Status Phase IIb ER+ breast cancer receiving N = 100 • Arm 1: AZD5363 + paclitaxel • PFS • FPD: Q1 2014 1st

60. Slide 60: Savolitinib (AZD6094) (MET)

    Approved medicines Late-stage development Savolitinib (AZD6094) (MET) Early development - IMED Early development - MedImmune Papillary renal cell and other cancers Trial phase Patient population Number of patients Design Endpoints Status Phase II Papillary renal cell cancer N = 90 • Single arm trial

61. Slide 61: AZD6738 (ATR) Solid tumours

    Approved medicines Late-stage development AZD6738 (ATR) Early development - IMED Early development - MedImmune Solid tumours Trial phase Patient population Number of patients Design Endpoints Status Phase I Solid tumours N = 160 • Arm 1: AZD6738 + carboplatin • Safety and tolerability • FPD: Q4 2014

62. Slide 62: AZD8186 (PI3Kb/d) Solid tumours

    Approved medicines Late-stage development AZD8186 (PI3Kb/d) Early development - IMED Early development - MedImmune Solid tumours Trial phase Patient population Number of patients Design Endpoints Status Phase I Advanced Castrate Resistant N = 153 • Part A: AZD8186 monotherapy in ascending intermitte

63. Slide 63: AZD9150 (STAT3) Solid tumours and blood cancers

    Approved medicines Late-stage development AZD9150 (STAT3) Early development - IMED Early development - MedImmune Solid tumours and blood cancers Trial phase Patient population Number of patients Design Endpoints Status Phase Ib/II Squamous Cell Carcinoma of N = 147 Dose Escalation advanced solid and

64. Slide 64: AZD9496 (SERD) Breast cancer

    Approved medicines Late-stage development AZD9496 (SERD) Early development - IMED Early development - MedImmune Breast cancer Trial phase Patient population Number of patients Design Endpoints Status Phase I ER+ Breast Cancer N ~ 150 • This is a Phase I open label multicentre trial of AZD9496 • Prim

65. Slide 65: AZD4076 (anti-miR 103/107) NASH

    Approved medicines Late-stage development AZD4076 (anti-miR 103/107) Early development - IMED Early development - MedImmune Non-alcoholic steatohepatitis (NASH) Trial phase Patient population Number of patients Design Endpoints Status Phase I Healthy subjects N = 40 SAD trial (one trial site in US)

66. Slide 66: AZD4831 Cardiovascular disease

    Approved medicines Late-stage development AZD4831 Early development - IMED Early development - MedImmune Cardiovascular disease Trial phase Patient population Number of patients Design Endpoints Status Phase I Healthy subjects N = 96 SMAD trial (one trial site in Germany) • Safety and tolerability •

67. Slide 67: AZD5718 Cardiovascular disease

    Approved medicines Late-stage development AZD5718 Early development - IMED Early development - MedImmune Cardiovascular disease Trial phase Patient population Number of patients Design Endpoints Status Phase I Healthy subjects N = 96 SMAD trial (one trial site in UK) • Safety and tolerability • FPD:

68. Slide 68: Abediterol (AZD0548) (LABA) Asthma

    Approved medicines Late-stage development Abediterol (AZD0548) (LABA) Early development - IMED Early development - MedImmune Asthma Trial phase Patient population Number of patients Design Endpoints Status Phase II Patients With N = 36 Single-dose 6-way crossover to investigate ultra-low doses of Pr

69. Slide 69: AZD1419 (TLR9 agonist) Asthma

    Approved medicines Late-stage development AZD1419 (TLR9 agonist) Early development - IMED Early development - MedImmune Asthma Trial phase Patient population Number of patients Design Endpoints Status Phase IIa Adults with eosinophilic, N = 70 • Arm 1: AZD1419, once-weekly adaptive dosing (4mg, 1mg,

70. Slide 70: AZD7594 (inhaled SGRM) Asthma/COPD

    Approved medicines Late-stage development AZD7594 (inhaled SGRM) Early development - IMED Early development - MedImmune Asthma/Chronic Obstructive Pulmonary Disease (COPD) Trial phase Patient population Number of patients Design Endpoints Status Phase II Patients with mild to moderate N = 48 A rando

71. Slide 71: AZD7986 (DPP1 inhibitor) COPD

    Approved medicines Late-stage development AZD7986 (DPP1 inhibitor) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Trial phase Patient population Number of patients Design Endpoints Status Phase I Healthy subjects N = 152 Part 1 (SAD) • Safety and

72. Slide 72: AZD8871 (MABA2) COPD

    Approved medicines Late-stage development AZD8871 (MABA2) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Trial phase Patient population Number of patients Design Endpoints Status Phase I Part 1: Mild N (Part 1) = 16 Part 1 Part 1 Endpoints: Part 1

73. Slide 73: AZD9567 (oSGRM) Respiratory

    Approved medicines Late-stage development AZD9567 (oSGRM) Early development - IMED Early development - MedImmune Respiratory Trial phase Patient population Number of patients Design Endpoints Status Phase I Healthy subjects N = 72 SAD trial with 6 dose levels - 2 μg, 10 μg, 40 μg, 100 μg, • A Phase

74. Slide 74: Verinurad Gout and hyperuricemia programme

    Approved medicines Late-stage development Verinurad (RDEA3170 - SURI, URAT1 inhibitor) Early development - IMED Early development - MedImmune Gout and hyperuricemia development programme Trial phase Patient population Number of patients Design Endpoints Status Phase II Combination therapy trial N =

75. Slide 75: AZD3241 (MPO) Multiple System Atrophy

    Approved medicines Late-stage development AZD3241 (MPO) Early development - IMED Early development - MedImmune Multiple System Atrophy (MSA) Trial phase Patient population Number of patients Design Endpoints Status Phase II Parkinson’s disease patients N = 24 • Arm 1: AZD3241 600mg BID for 8 weeks •

76. Slide 76: AZD8108 (NMDA) Phase I programme

    Approved medicines Late-stage development AZD8108 (NMDA) Early development - IMED Early development - MedImmune Phase I clinical development programme Trial phase Patient population Number of patients Design Endpoints Status Phase I Healthy subjects N = 40 • Randomised, double-blind, placebo-control

77. Slide 77: Early development - MedImmune

    MedImmune Early development - MedImmune

78. Slide 78: Durvalumab (MEDI4736; PD-L1 mAb) Immuno-oncology

    Approved medicines Late-stage development Durvalumab (MEDI4736; PD-L1 mAb) Early development - IMED Early development - MedImmune Immuno-oncology Trial phase Compound Patient population Number of patients Design Endpoints Status Phase I/II PD-L1 (durvalumab) Solid tumours N = 1,014 • Dose Escalation

79. Slide 79: Durvalumab + tremelimumab Solid and hematologic tumours

    Durvalumab (MEDI4736; PD-L1 mAb) Approved medicines Late-stage development Early development - IMED + tremelimumab (CTLA-4 mAb) Early development - MedImmune Solid and hematologic tumours Trial phase Patient population Number of patients Design Endpoints Status Phase Ib/II Gastric or GEJ N = 236 • A

80. Slide 80: Durvalumab + Iressa (gefitinib) NSCLC

    Approved medicines Late-stage development Durvalumab (MEDI4736; PD-L1 mAb) Early development - IMED Early development - MedImmune + Iressa (gefitinib) Non-small cell lung cancer (NSCLC) Trial phase Patient population Number of patients Design Endpoints Status Phase I NSCLC N = 36 Escalation phase •

81. Slide 81: Durvalumab + MEDI0680 (PD-1 mAb) Advanced cancers

    Approved medicines Late-stage development Durvalumab (MEDI4736) + MEDI0680 (PD-1 mAb) Early development - IMED Early development - MedImmune Advanced cancers Trial phase Patient population Number of patients Design Endpoints Status Phase I Advanced malignancies N = 150 Dose-escalation phase • Safety

82. Slide 82: Durvalumab + Tafinlar/Mekinist Melanoma

    Approved medicines Late-stage development Durvalumab (MEDI4736; PD-L1 mAb) + Tafinlar Early development - IMED Early development - MedImmune (dabrafenib)/ Mekinist (trametinib) Melanoma Trial phase Patient population Number of patients Design Endpoints Status Phase I/II Metastatic or unresectable N

83. Slide 83: MEDI0562 (OX40 mAb) Advanced cancers

    Approved medicines Late-stage development MEDI0562 (OX40 mAb) Early development - IMED Early development - MedImmune MEDI0562 (OX40 mAb) + durvalumab (MEDI4736; PD-L1) or tremelimumab (CTLA-4 mAb) Advanced cancers Trial phase Patient population Number of patients Design Endpoints Status Phase I Adva

84. Slide 84: Inebilizumab (MEDI-551, CD19 mAb) Blood cancers

    Approved medicines Late-stage development Inebilizumab (MEDI-551, CD19 mAb) Early development - IMED Early development - MedImmune Blood cancers Trial phase Patient population Number of patients Design Endpoints Status Phase II Adults with relapsed or N = 170 • Arm 1: MEDI-551 dose level 1 and ICE/D

85. Slide 85: MEDI1873 (GITR agonist) Solid tumours

    Approved medicines Late-stage development MEDI1873 (GITR agonist) Early development - IMED Early development - MedImmune Solid tumours Trial phase Patient population Number of patients Design Endpoints Status Phase I Adult subjects with select N = 42 Dose-escalation phase • Safety • FPD: Q4 2015 adv

86. Slide 86: MEDI4276 (HER2 ADC mAb) Advanced cancers

    Approved medicines Late-stage development MEDI4276 (HER2 ADC mAb) Early development - IMED Early development - MedImmune Advanced cancers Trial phase Patient population Number of patients Design Endpoints Status Phase I Advanced HER2+ metastatic Dose escalation • First-time-in-human Phase 1, multi-c

87. Slide 87: MEDI9197 (TLR7/8 agonist) Solid tumours

    Approved medicines Late-stage development MEDI9197 (TLR7/8 agonist) Early development - IMED Early development - MedImmune Solid tumours Trial phase Patient population Number of patients Design Endpoints Status Phase I Advanced solid tumour N = 43 Dose-escalation phase • Safety • FPD: Q4 2015 malign

88. Slide 88: MEDI9447 (CD73 mAb) + durvalumab Advanced cancers

    Approved medicines Late-stage development MEDI9447 (CD73 mAb) + durvalumab Early development - IMED Early development - MedImmune (MEDI4736; PD-L1 mAb) Advanced cancers Trial phase Patient population Number of patients Design Endpoints Status Phase I Advanced malignancies N = 188 Dose-escalation pha

89. Slide 89: Other biologics Solid tumours

    Approved medicines Late-stage development Other biologics Early development - IMED Early development - MedImmune Solid tumours Trial phase Compound Patient population Number of patients Design Endpoints Status Phase I/II Anti-IGF ligand mAb Patients with HR+ N = 176 • Arm 1: MEDI-573 IV and Aromatas

90. Slide 90: Biologics Cardiovascular & metabolic disease

    Approved medicines Late-stage development Biologics Early development - IMED Early development - MedImmune Cardiovascular & metabolic disease Trial phase Compound Patient population Number of patients Design Endpoints Status Phase IIa rhLCAT Adults with stable N = 56 • SAD in stable CAD patients • S

91. Slide 91: MEDI7836 (IL-13 mAb) Asthma

    Approved medicines Late-stage development MEDI7836 (IL-13 mAb) Early development - IMED Early development - MedImmune Asthma Trial phase Patient population Number of patients Design Endpoints Status Phase I Healthy subjects N = 32 • Arm 1: 30mg MEDI7836 (n = 6) or placebo (n = 2) as a single • Safet

92. Slide 92: MEDI9929 tezepelumab (TSLP mAb) Asthma

    Approved medicines Late-stage development MEDI9929 tezepelumab (TSLP mAb) Early development - IMED Early development - MedImmune Asthma Trial phase Patient population Number of patients Design Endpoints Status Phase II Adult subjects with inadequately N = 552 • Arm 1: Placebo • Reduction in the annu

93. Slide 93: MEDI0700 - AMG 570 Systemic Lupus Erythematosus

    Approved medicines Late-stage development MEDI0700 - AMG 570 (Anti-B7RP-1 mAb/BAFF) Early development - IMED Early development - MedImmune Systemic Lupus Erythematosus (SLE) Trial phase Patient population Number of patients Design Endpoints Status Phase Ia Healthy Subjects N = 40 Single Ascending Do

94. Slide 94: MEDI1814 (amyloid beta mAb) Alzheimer's disease

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95. Slide 95: MEDI5872 - AMG 557 (B7RP-1 mAb) SLE

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96. Slide 96: MEDI7352 (NGF TNF Bispecific) Osteoarthritis pain

    Approved medicines Late-stage development MEDI7352 (NGF TNF Bispecific) Early development - IMED Early development - MedImmune Osteoarthritis pain Number of Trial phase Compound Patient population Design Endpoints Status patients Phase I MEDI7352 (NGF TNF Painful osteoarthritis of the N = 160 • SAD

97. Slide 97: MEDI9314 (IL-4Ra mAb) Atopic Dermatitis

    Approved medicines Late-stage development MEDI9314 (IL-4Ra mAb) Early development - IMED Early development - MedImmune Atopic Dermatitis Trial phase Patient population Number of patients Design Endpoints Status Phase I Healthy subjects N = 44 • Arm 1: 45mg MEDI9314 (n = 4) or placebo (n = 2) as a si

98. Slide 98: Other biologics Autoimmunity

    Approved medicines Late-stage development Other biologics Early development - IMED Early development - MedImmune Autoimmunity Trial phase Compound Patient population Number of patients Design Endpoints Status Phase II/III Inebilizumab Adults with N = 212 (estimated) • Arm 1: MEDI-551 500mg IV • Prim

99. Slide 99: Other biologics Infections

    Approved medicines Late-stage development Other biologics Early development - IMED Early development - MedImmune Infections Trial phase Compound Patient population Number of patients Design Endpoints Status Phase II Anti-Staph AT Intubated ICU N = 462 • Placebo-controlled, single-dose, dose-ranging

100. Slide 100: Other biologics Infections

     Approved medicines Late-stage development Other biologics Early development - IMED Early development - MedImmune Infections Trial phase Compound Patient population Number of patients Design Endpoints Status Phase Ib/IIa Anti-influenza A Adults N = 160 • Randomised, partial double-blind, single dose,

101. Slide 101: Clinical trials appendix: Year-To-Date and Q3 2016 Results update

     Clinical trials appendix Year-To-Date and Q3 2016 Results update

AstraZeneca — Q3 2016 Earnings Presentation on 6ix