Astrazeneca Plc · LSE:AZN

Astrazeneca — Q3 2015 Earnings Presentation

107 slides from Astrazeneca's earnings presentation, Nov 5, 2015

1. Slide 1: Clinical Trials Appendix Q3 2015 Update

   Clinical Trials Appendix Q3 2015 Update

2. Slide 2: Information about AstraZeneca clinical studies and clinicaltrials.gov

   The following information about AstraZeneca clinical studies in Phases I-IV has been created with selected information from clinicaltrials.gov to facilitate understanding of key aspects of our clinical programmes and is correct to the best of our knowledge as of 30 September 2015, unless otherwise s

3. Slide 3: List of abbreviations

   List of abbreviations AEs Adverse Events LCM Lifecycle Management Q3W Every Three Weeks ASA Acetylsalicylic Acid LPD Last Patient Dosed Q4W Every Four Weeks BiD Twice Daily MAD Multiple Ascending Dose Study Q8W Every Eight Weeks CE Clinically Evaluable MDI Metered Dose Inhaler QD Once Daily cMITT Cl

4. Slide 4: Movement since Q2 2015 update

   Movement since Q2 2015 update New to Phase I New to Phase II New to Pivotal Study New to Registration NMEs NMEs NMEs AZD9977 AZD5069+durvalumab# PT003 Count as MCR diabetic kidney disease CXCR2+PD-L1 SCCHN COPD single MEDI9447 AZD9150#+durvalumab# project CD73 solid tumours STAT3+PD-L1 SCCHN AZD7594

5. Slide 5: Q3 New Molecular Entity (NME) Pipeline

   Q3 New Molecular Entity (NME)1 Pipeline RIA CVMD Oncology Infection, Neuroscience, Gastrointestinal 1 Includes significant fixed dose combination projects, and parallel indications that are in a separate therapeutic area (See LCM chart for other parallel indications and oncology combination projects

6. Slide 6: Q3 Lifecycle Management (LCM) Pipeline

   Q3 Lifecycle Management (LCM)1 Pipeline RIA CVMD Oncology Infection, Neuroscience, Gastrointestinal 1 Includes significant LCM projects and parallel indications for assets in Phase III or beyond. Excludes LCM projects already launched in a major market # Partnered; ¶ Registrational Phase II/III stud

7. Slide 7: 14-16 NME & LCM submissions 2015-2017

   2015-2017: durvalumab + 14-16 NME & LCM submissions tremelimumab 2L SCCHN durvalumab 2L SCCHN durvalumab + tremelimumab 3L NSCLC durvalumab stage III NSCLC AZD9291 (EGFR T790) 1L NSCLC LCM submission Lynparza pancreatic cancer opportunities Faslodex Lynparza 1L metastatic breast cancer 1L BRCAm ovar

8. Slide 8: Immuno-oncology Major trials I

   Immuno-oncology Major trials I Tumour type Line of therapy Treme Combo Durva (CTLA-4 mAb) durva + treme (PD-L1 mAb) Mesothelioma Second line DETERMINE Phase II NSCLC Adjuvant ADJUVANT Phase III Stage III un-resectable PACIFIC Phase III First line MYSTIC MYSTIC Phase III (PFS) Phase III (PFS) NEPTUNE

9. Slide 9: Immuno-oncology Major trials II

   Immuno-oncology Major trials II Tumour type Line of Treme Combo Durva Combo OX40 CD73 Combo durva TLR7/8 therapy (CTLA-4 mAb) durva + treme (PD-L1 mAb) durva + OX40 + CD73 SCCHN Second line EAGLE EAGLE Phase III Phase III PD-L1- CONDOR CONDOR CONDOR Phase II Phase II HAWK PD-L1+ Phase II Gastric Sec

10. Slide 10: Lifecycle management (new uses of existing medicines)

    AstraZeneca Lifecycle management (new uses of existing medicines)

11. Slide 11: Symbicort (ICS/LABA) Mild asthma

    Lifecycle management Late-stage development Symbicort (ICS/LABA) Early development - IMED Early development - MedImmune Mild asthma Patient population Study phase Number of patients Design Endpoints Status Patients in need of GINA step Phase III N = 3,750 • Arm 1: Symbicort Turbuhaler 160/4.5 μg 'as

12. Slide 12: Eklira/Tudorza (LAMA) COPD

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

13. Slide 13: Duaklir (LAMA/LABA) COPD

    Lifecycle management Late-stage development Duaklir (LAMA/LABA) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Patient population Study phase Number of patients Design Endpoints Status Patients with moderate to Phase IV N = 268 • Arm 1: Aclidinium

14. Slide 14: Brilinta/Brilique Cardiovascular

    Lifecycle management Late-stage development Brilinta/Brilique (ADP receptor antagonist) Early development - IMED Early development - MedImmune Cardiovascular Patient population Study phase Number of patients Design Endpoints Status Patients with prior MI Phase III N = 21,000 • Arm 1: Ticagrelor 90 m

15. Slide 15: Epanova Hypertriglyceridaemia

    Lifecycle management Late-stage development Epanova (omega-3 carboxylic acids) Early development - IMED Early development - MedImmune Hypertriglyceridaemia Patient population Study phase Number of patients Design Endpoints Status Type 2 DiM Phase II N = 80 • Arm 1: Epanova 4g QD • Reduction in liver

16. Slide 16: Epanova Hypertriglyceridaemia

    Lifecycle management Late-stage development Epanova (omega-3 carboxylic acids) Early development - IMED Early development - MedImmune Hypertriglyceridaemia Patient population Study phase Number of patients Design Endpoints Status Severe hyper-triglyceridaemia Phase III N = 162 • Arm 1: Epanova 2g QD

17. Slide 17: Onglyza Type 2 Diabetes

    Lifecycle management Late-stage development Onglyza (DPP-4 inhibitor) Early development - IMED Early development - MedImmune Type 2 Diabetes Patient population Study phase Number of patients Design Endpoints Status Type 2 diabetes mellitus Phase III N = 444 • Arm 1: Onglyza 5 mg QD +insulin or Ongly

18. Slide 18: Farxiga/Forxiga Diabetes

    Lifecycle management Late-stage development Farxiga/Forxiga (SGLT-2 inhibitor) Early development - IMED Early development - MedImmune Diabetes Patient population Study phase Number of patients Design Endpoints Status Type 2 diabetes Phase III/IV N = 17276 • Arm 1: Forxiga 10 mg QD + standard of care

19. Slide 19: Farxiga/Forxiga Diabetes

    Lifecycle management Late-stage development Farxiga/Forxiga (SGLT-2 inhibitor) Early development - IMED Early development - MedImmune Diabetes Patient population Study phase Number of patients Design Endpoints Status Type 1 diabetes mellitus Phase III N = 768 • Arm 1: Forxiga 5 mg QD 52 weeks + insu

20. Slide 20: Saxagliptin/dapagliflozin Diabetes

    Lifecycle management Late-stage development Saxagliptin/dapagliflozin (DPP-4/SGLT-2 inhibitors) Early development - IMED Early development - MedImmune Diabetes Patient population Study phase Number of patients Design Endpoints Status Type 2 diabetes mellitus Phase III N = 280 • Arm 1: Saxa 5mg + Dap

21. Slide 21: Bydureon Type 2 Diabetes

    Lifecycle management Late-stage development Bydureon (GLP-1 receptor agonist) Early development - IMED Early development - MedImmune Type 2 Diabetes Patient population Study phase Number of patients Design Endpoints Status Type 2 diabetes Phase III N = 375 • Arm 1: Bydureon BiD SC (autoinjector) • C

22. Slide 22: Bydureon Type 2 Diabetes

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

23. Slide 23: Faslodex Breast cancer - metastatic

    Lifecycle management Late-stage development Faslodex (oestrogen receptor antagonist) Early development - IMED Early development - MedImmune Breast cancer - metastatic Patient population Study phase Number of patients Design Endpoints Status Postmenopausal women with Phase III N ~450 • Arm 1: Faslode

24. Slide 24: Lynparza Ovarian cancer and other solid tumours

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

25. Slide 25: Lynparza Solid tumours

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

26. Slide 26: Nexium, Linaclotide Gastrointestinal

    Lifecycle management Late-stage development Early development – IMED Nexium, Linaclotide Early development - MedImmune Gastrointestinal Compound Patient population Study phase Number of patients Design Endpoints Status Nexium Seriously ill patients Phase III N = 300 • Arm 1: Nexium 40 mg bid intermi

27. Slide 27: Late-stage development

    AstraZeneca Late-stage development

28. Slide 28: Lesinurad Gout

    Lifecycle management Late-stage development Early development – IMED Lesinurad (SURI, URAT1 inhibitor) Early development - MedImmune Gout Patient population Study phase Number of patients Design Endpoints Status Gout previously enrolled in Phase II N = 87 • lesinurad 200, 400, or 600 mg QD • Assess

29. Slide 29: Brodalumab Psoriasis & psoriatic arthritis

    Lifecycle management Late-stage development Brodalumab (IL-17R mAb) Early development - IMED Early development - MedImmune Psoriasis & psoriatic arthritis Patient population Study phase Number of patients Design Endpoints Status Moderate to severe plaque Phase III N = 661 • Arm 1: 210 mg brodalumab

30. Slide 30: PT003 (LABA/LAMA) COPD

    Lifecycle management Late-stage development PT003 (LABA/LAMA) Early development - IMED Early development - MedImmune COPD Patient population Study phase Number of patients Design Endpoints Status Moderate to severe COPD Phase IIIb N = 150 Treatment ( 5- to 6- week Treatment Period) Percentage of dev

31. Slide 31: PT003 (LABA/LAMA) COPD

    Lifecycle management Late-stage development PT003 (LABA/LAMA) Early development - IMED Early development - MedImmune COPD Patient population Study phase Number of patients Design (G = Glycopyrronium, F = Formoterol fumarate) Endpoints Status Moderate to severe COPD Phase IIIb N = 40 Treatments ( 8-w

32. Slide 32: PT009 (ICS/LABA) COPD & Asthma

    Lifecycle management Late-stage development PT009 (ICS/LABA) Early development - IMED Early development - MedImmune COPD & Asthma Patient population Study phase Number of patients Design (G = Glycopyrronium, F = Formoterol fumarate) Endpoints Status Moderate to severe COPD Phase II N = 180 • BFF MDI

33. Slide 33: PT010 (LABA/LAMA/ICS) COPD & Asthma

    Lifecycle management Late-stage development PT010 (LABA/LAMA/ICS) Early development - IMED Early development - MedImmune COPD & Asthma Patient population Study phase Number of patients Design Endpoints Status Adult mild to moderate Phase II N = 150 • Arm 1: BD MDI 320 μg BiD • Change from baseline i

34. Slide 34: PT010 (LABA/LAMA/ICS) COPD & Asthma

    Lifecycle management Late-stage development PT010 (LABA/LAMA/ICS) Early development - IMED Early development - MedImmune COPD & Asthma Patient population Study phase Number of patients Design Endpoints Status Intermittent asthma/mild to Phase II N = 200 Treatment (18-week Treatment Period) Peak chan

35. Slide 35: PT010 (LABA/LAMA/ICS) COPD & Asthma

    Lifecycle management Late-stage development PT010 (LABA/LAMA/ICS) Early development - IMED Early development - MedImmune COPD & Asthma Patient population Study phase Number of patients Design Endpoints Status Moderate to very severe COPD Phase III N = 500 Treatments ( 52-week Treatment Period) Bone

36. Slide 36: PT010 (LABA/LAMA/ICS) COPD & Asthma

    Lifecycle management Late-stage development PT010 (LABA/LAMA/ICS) Early development - IMED Early development - MedImmune COPD & Asthma Patient population Study phase Number of patients Design Endpoints Status Japanese healthy volunteers Phase I N = 24 Treatment (4-day Treatment Period) • Overall saf

37. Slide 37: Benralizumab Asthma

    Lifecycle management Late-stage development Benralizumab (IL-5R mAb) Early development - IMED Early development - MedImmune Asthma Patient population Study phase Number of patients Design Endpoints Status Severe asthma, inadequately Phase III N = 1026 HD + ~200 • Arm 1: 30 mg Q8w SC • Annual asthma

38. Slide 38: Benralizumab Asthma

    Lifecycle management Late-stage development Benralizumab (IL-5R mAb) Early development - IMED Early development - MedImmune Asthma Patient population Study phase Number of patients Design Endpoints Status Asthmatic with FEV1 (50-90% Phase III N = 200 • Arm 1: 30 mg Q4w SC • Pulmonary function (FEV1

39. Slide 39: Benralizumab COPD

    Lifecycle management Late-stage development Benralizumab (IL-5R mAb) Early development - IMED Early development - MedImmune COPD Patient population Study phase Number of patients Design Endpoints Status Moderate to very severe Phase III N = 2,168 • Arm 1: 10 mg Q8w SC • Rate of COPD exacerbation •

40. Slide 40: Tralokinumab Asthma

    Lifecycle management Late-stage development Tralokinumab (IL-13 mAb) Early development - IMED Early development - MedImmune Asthma Patient population Study phase Number of patients Design Endpoints Status Adults with uncontrolled Phase III N = 1,140 Cohort 1: Primary: • FPD: Q3 14 severe asthma STRA

41. Slide 41: Tralokinumab Idiopathic Pulmonary Fibrosis

    Lifecycle management Late-stage development Tralokinumab (IL-13 mAb) Early development - IMED Early development - MedImmune Idiopathic Pulmonary Fibrosis (IPF) Patient population Study phase Number of patients Design Endpoints Status Adults with Idiopathic Phase II N = 176 • Arm 1: Tralokinumab high

42. Slide 42: Tralokinumab Atopic dermatitis

    Lifecycle management Late-stage development Tralokinumab (IL-13 mAb) Early development - IMED Early development - MedImmune Atopic dermatitis Patient population Study phase Number of patients Design Endpoints Status Adults with atopic dermatitis Phase II N = 204 • Arm 1: Tralokinumab dose 45mg SC •

43. Slide 43: Anifrolumab Systemic Lupus Erythematosus

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

44. Slide 44: Roxadustat Chronic Kidney Disease

    Lifecycle management Late-stage development Roxadustat (HIF-PHI) Early development - IMED Early development - MedImmune Chronic Kidney Disease (CKD) Patient population Study phase Number of patients Design Endpoints Status Anaemia in Chronic Kidney Phase III ANDES N = 600 • Arm 1: Roxadustat Haemogl

45. Slide 45: AZD9291 NSCLC

    Lifecycle management Late-stage development AZD9291 (Highly selective, irreversible EGFR TKI) Early development - IMED Early development - MedImmune Non-small cell lung cancer (NSCLC) Patient population Study phase Number of patients Design Endpoints Status Advanced EGFRm NSCLC TKI Phase III N = 410

46. Slide 46: AZD9291 NSCLC

    Lifecycle management Late-stage development AZD9291 (Highly selective, irreversible EGFR TKI) Early development - IMED Early development - MedImmune Non-small cell lung cancer (NSCLC) Patient population Study phase Number of patients Design Endpoints Status Adjuvant EGFRm NSCLC, Phase III N = 700 •

47. Slide 47: Tremelimumab Mesothelioma

    Lifecycle management Late-stage development Tremelimumab (CTLA-4 mAb) Early development - IMED Early development - MedImmune Mesothelioma Patient population Study phase Number of patients Design Endpoints Status Patients with unresectable Phase II N = 564 • Arm 1: Tremelimumab IV • Overall survival

48. Slide 48: Durvalumab NSCLC

    Lifecycle management Late-stage development Durvalumab (MEDI4736; PD-L1 mAb) Early development - IMED Early development - MedImmune Non-small cell lung cancer (NSCLC) Patient population Study phase Number of patients Design Endpoints Status Adjuvant NSCLC patients Phase III N = 1,100 • Arm 1: MEDI47

49. Slide 49: Durvalumab SCCHN and other solid tumours

    Lifecycle management Late-stage development Durvalumab (MEDI4736; PD-L1 mAb) Early development - IMED Early development - MedImmune SCCHN and other solid tumours Patient population Study phase Number of patients Design Endpoints Status SCCHN Phase II N = 112 • Single-arm: MEDI4736 IVQ2W • ORR • FPD:

50. Slide 50: Durvalumab + tremelimumab Solid tumours

    Lifecycle management Late-stage development Durvalumab (MEDI4736; PD-L1 mAb) Early development - IMED Early development - MedImmune + tremelimumab (CTLA-4 mAb) Solid tumours Patient population Study phase Number of patients Design Endpoints Status Stage IIIB-IV 3L NSCLC Phase III N = 900 Substudy A

51. Slide 51: Durvalumab + tremelimumab Solid tumours

    Lifecycle management Late-stage development Durvalumab (MEDI4736; PD-L1 mAb) Early development - IMED Early development - MedImmune + tremelimumab (CTLA-4 mAb) Solid tumours Patient population Study phase Number of patients Design Endpoints Status SCCHN 2L Phase III N = 720 • Arm 1: MEDI4736 + treme

52. Slide 52: Cediranib Ovarian cancer

    Lifecycle management Late-stage development Cediranib (VEGF inhibitor) Early development - IMED Early development - MedImmune Ovarian cancer Patient population Study phase Number of patients Design Endpoints Status Patients with platinum- Phase III N = 486 • Arm 1: Placebo • Progression Free Surviva

53. Slide 53: Moxetumomab pasudotox Haematological malignancies

    Lifecycle management Late-stage development Moxetumomab pasudotox (CD22 mAb) Early development - IMED Early development - MedImmune Haematological malignancies Patient population Study phase Number of patients Design Endpoints Status Adults with relapsed or Phase III N = 77 • Multicentre, single-arm

54. Slide 54: Selumetinib (AZD6244) Solid tumours

    Lifecycle management Late-stage development Selumetinib (AZD6244) (MEK-inhibitor) Early development - IMED Early development - MedImmune Solid tumours Patient population Study phase Number of patients Design Endpoints Status 2L KRASm positive NSCLC Phase III N = 634 • Arm 1: Selumetinib 75mg BiD + d

55. Slide 55: CAZ-AVI Serious infections

    Lifecycle management Late-stage development CAZ-AVI (BLI/cephalosporin SBI) Early development - IMED Early development - MedImmune Serious infections Patient population Study phase Number of patients Design Endpoints Status Hospitalised adults with Phase III N = 563 • Arm 1: CAZ-AVI 2000/500mg IV pl

56. Slide 56: AZD3293 Alzheimer's disease

    Lifecycle management Late-stage development AZD3293 (BACE inhibitor) Early development - IMED Early development - MedImmune Alzheimer’s disease Patient population Study phase Number of patients Design Endpoints Status Alzheimer’s disease patients Phase II/III N = 2,202 • Arm 1: AZD3293 20 mg once da

57. Slide 57: Early development - IMED

    AstraZeneca Early development - IMED

58. Slide 58: AZD7594 Asthma/COPD

    Lifecycle management Late-stage development AZD7594 (inhaled SGRM) Early development - IMED Early development - MedImmune Asthma/COPD Patient population Study phase Number of patients Design Endpoints Status Patients with mild to moderate Phase II N = 48 Sequence 1 • Forced expiratory volume in one

59. Slide 59: AZD7624 COPD

    Lifecycle management Late-stage development AZD7624 (p38 inhibitor) Early development - IMED Early development - MedImmune COPD Patient population Study phase Number of patients Design Endpoints Status Healthy subjects Phase I N = 48 SAD • Safety and tolerability following inhaled • FPD: Q1 13 • Fiv

60. Slide 60: AZD7986 COPD

    Lifecycle management Late-stage development AZD7986 (DPP1 inhibitor) Early development - IMED Early development - MedImmune COPD Patient population Study phase Number of patients Design Endpoints Status Healthy subjects Phase I N = 152 Part 1 (SAD) • Safety and tolerability and PK following • FPD: Q

61. Slide 61: AZD8999 Asthma/COPD

    Lifecycle management Late-stage development AZD8999 (MABA1) Early development - IMED Early development - MedImmune Asthma/COPD Patient population Study phase Number of patients Design Endpoints Status Part 1: Mild Asthmatic Phase I N (Part 1) = 17 Part 1 Part 1 Endpoints: Part 1 SAD study with 6 dos

62. Slide 62: AZD8871 Asthma/COPD

    Lifecycle management Late-stage development AZD8871 (MABA2) Early development - IMED Early development - MedImmune Asthma/COPD Patient population Study phase Number of patients Design Endpoints Status Part 1: Mild Asthmatic Phase I N (Part 1) = 16 Part 1 Part 1 Endpoints: Part 1 SAD study with 6 pla

63. Slide 63: RDEA3170 Gout and hyperuricemia development programme

    Lifecycle management Late-stage development RDEA3170 (SURI, URAT1 inhibitor) Early development - IMED Early development - MedImmune Gout and hyperuricemia development programme Patient population Study phase Number of patients Design Endpoints Status Monotherapy study in Phase II N = 160 • Arm A: Pl

64. Slide 64: RDEA3170 Gout and hyperuricemia

    Lifecycle management Late-stage development RDEA3170 (SURI, URAT1 inhibitor) Early development - IMED Early development - MedImmune Gout and hyperuricemia Patient population Study phase Number of patients Design Endpoints Status Combination therapy study Phase II N = 40 • Arm A: Placebo • To assess

65. Slide 65: AZD9977 Diabetic kidney disease

    Lifecycle management Late-stage development AZD9977 (mineralocorticoid receptor modulator) Early development - IMED Early development - MedImmune Diabetic kidney disease Patient population Study phase Number of patients Design Endpoints Status Healthy subjects Phase I N = up to 88 Part A: Single Asc

66. Slide 66: AZD4901 Phase II clinical development programme

    Lifecycle management Late-stage development AZD4901 (NK3 Receptor Antagonist) Early development - IMED Early development - MedImmune Phase II clinical development programme Patient population Study phase Number of patients Design Endpoints Status Polycystic ovary syndrome Phase IIa N = 56 • Arm 1: A

67. Slide 67: AZD1775 Solid tumours, ovarian and NSCLC

    Lifecycle management Late-stage development AZD1775 (WEE-1) Early development - IMED Early development - MedImmune Solid tumours, ovarian cancer and non-small cell lung cancer Patient population Study phase Number of patients Design Endpoints Status p53 mutant advanced solid Phase I/II N = 132 • Mon

68. Slide 68: Savolitinib (AZD6094) Papillary renal cell and other cancers

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

69. Slide 69: AZD2014 Breast and squamous NSCLC cancer

    Lifecycle management Late-stage development AZD2014 (TORC 1/2) Early development - IMED Early development - MedImmune Breast and squamous NSCLC cancer Patient population Study phase Number of patients Design Endpoints Status 2nd line ER+ metastatic breast Phase II N = 316 • Arm 1: Fulvestrant • Prog

70. Slide 70: AZD3759 Lung cancer with metastases

    Lifecycle management Late-stage development AZD3759 (EGFRm BBB) Early development - IMED Early development - MedImmune Lung cancer with lung and/or brain metastases Patient population Study phase Number of patients Design Endpoints Status EGFRm+ NSCLC Phase I N = 47 • MAD • Safety and tolerability •

71. Slide 71: AZD4547 (FGFR) Solid tumours

    Lifecycle management Late-stage development AZD4547 (FGFR) Early development - IMED Early development - MedImmune Solid tumours Patient population Study phase Number of patients Design Endpoints Status Stage IIIB-IV NSCLC patients Phase II/III Lung N = 318 (AZD4547 5-Arm study based on biomarker exp

72. Slide 72: AZD4547 (FGFR) Solid tumours

    Lifecycle management Late-stage development AZD4547 (FGFR) Early development - IMED Early development - MedImmune Solid tumours Patient population Study phase Number of patients Design Endpoints Status Advanced cancer who have Phase I N = 94 • Part A: Ascending oral doses of AZD4547 to define maximu

73. Slide 73: AZD9496 (SERD) Breast cancer

    Lifecycle management Late-stage development AZD9496 (SERD) Early development - IMED Early development - MedImmune Breast cancer Patient population Study phase Number of patients Design Endpoints Status ER+ Breast Cancer Phase I N ~150 • This is a Phase I open label multicentre study of AZD9496 • Pri

74. Slide 74: AZD5312 (ISIS-AR) Solid tumours

    Lifecycle management Late-stage development AZD5312 (ISIS-AR) Early development - IMED Early development - MedImmune Solid tumours Patient population Study phase Number of patients Design Endpoints Status Advanced solid tumours with Phase I N = 90 Part A: Dose escalation • Part A: MTD and Recommende

75. Slide 75: AZD5363 (AKT) Solid tumours

    Lifecycle management Late-stage development AZD5363 (AKT) Early development - IMED Early development - MedImmune Solid tumours Patient population Study phase Number of patients Design Endpoints Status ER+ breast cancer receiving Phase IIb N = 100 • Arm 1: AZD5363 + paclitaxel • Progression Free surv

76. Slide 76: AZD6738 (ATR) Solid tumours

    Lifecycle management Late-stage development AZD6738 (ATR) Early development - IMED Early development - MedImmune Solid tumours Patient population Study phase Number of patients Design Endpoints Status Solid tumours Phase I N = 160 • Arm 1: AZD6738 + carboplatin • Safety and tolerability • FPD: Q4 14

77. Slide 77: AZD8186 (PI3Kb/d) Solid tumours

    Lifecycle management Late-stage development AZD8186 (PI3Kb/d) Early development - IMED Early development - MedImmune Solid tumours Patient population Study phase Number of patients Design Endpoints Status Advanced Phase I N = 96 • Part A: AZD8186 monotherapy in ascending intermittent doses in • Part

78. Slide 78: AZD8835 Solid tumours

    Lifecycle management Late-stage development AZD8835 (PI3Kα/δ inhibitor) Early development - IMED Early development - MedImmune Solid tumours Patient population Study phase Number of patients Design Endpoints Status Women with estrogen receptor Phase I N = 100 • Part A: AZD8835 single agent dose esca

79. Slide 79: AZD9150 (STAT3) Haematological malignancies

    Lifecycle management Late-stage development AZD9150 (STAT3) Early development - IMED Early development - MedImmune Haematological malignancies Patient population Study phase Number of patients Design Endpoints Status SCCHN Phase Ib/II N = 147 Dose Escalation advanced solid malignancies • Safety/Effi

80. Slide 80: ATM-AVI Infections

    Lifecycle management Late-stage development ATM-AVI Early development - IMED Early development - MedImmune Infections Compound Patient population Study phase Number of patients Design Endpoints Status ATM-AVI Healthy volunteers Phase I • randomized, double-blind, 3-part study in • Safety/tolerabilit

81. Slide 81: AZD8108 (NMDA) Phase I programme

    Lifecycle management Late-stage development AZD8108 (NMDA) Early development - IMED Early development - MedImmune Phase I clinical development programme Patient population Study phase Number of patients Design Endpoints Status Healthy volunteers Phase I N = 40 • Randomized, double-blind, placebo-con

82. Slide 82: AZD3241 (MPO) Multiple System Atrophy

    Lifecycle management Late-stage development AZD3241 (MPO) Early development - IMED Early development - MedImmune Multiple System Atrophy Patient population Study phase Number of patients Design Endpoints Status Healthy subjects Phase I N = 46 • Active ArmS: SAD • AEs, labs, vital signs, ECGs • Study

83. Slide 83: Early development - MedImmune

    MedImmune Early development - MedImmune

84. Slide 84: MEDI7836 (IL-13 mAb) Asthma

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

85. Slide 85: MEDI9929 (TSLP mAb) Asthma

    Lifecycle management Late-stage development MEDI9929 (TSLP mAb) Early development - IMED Early development - MedImmune Asthma Patient population Study phase Number of patients Design Endpoints Status Adult subjects with Phase II N = 552 • Arm 1: Placebo • Reduction in the annualized asthma • FPD: Q2

86. Slide 86: MEDI5872 (B7RP-1 mAb) SLE

    Lifecycle management Late-stage development MEDI5872 (B7RP-1 mAb) Early development - IMED Early development - MedImmune Systemic Lupus Erythematosus (SLE) Patient population Study phase Number of patients Design Endpoints Status SLE and lupus related Phase I N = 40 Dose escalation study: • Safety a

87. Slide 87: Mavrilimumab Rheumatoid arthritis

    Lifecycle management Late-stage development Mavrilimumab (GMCSF mAb) Early development - IMED Early development - MedImmune Rheumatoid arthritis (RA) Patient population Study phase Number of patients Design Endpoints Status RA patients who have failed 1 Phase II N = 138 • Arm 1: Mavrilimumab SC • AC

88. Slide 88: Other biologics Inflammation

    Lifecycle management Late-stage development Other biologics Early development - IMED Early development - MedImmune Inflammation Compound Patient population Study phase Number of patients Design Endpoints Status Anti-α4β7 Moderate to severe Phase II N = 359 • Arm 1: MEDI7183 dose level 1, SC • Remiss

89. Slide 89: Other biologics Autoimmunity

    Lifecycle management Late-stage development Other biologics Early development - IMED Early development - MedImmune Autoimmunity Compound Patient population Study phase Number of patients Design Endpoints Status Anti-CD19 mAb Adults with Phase II/III N = 212 (est.) • Arm 1: MEDI-551500mg IV • Primary

90. Slide 90: Other biologics Cardiovascular & metabolic disease

    Lifecycle management Late-stage development Other biologics Early development - IMED Early development - MedImmune Cardiovascular & metabolic disease Compound Patient population Study phase Number of patients Design Endpoints Status rhLCAT Adults with stable Phase I N = 16 • SAD IV • Safety • Comple

91. Slide 91: Durvalumab + Iressa NSCLC

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

92. Slide 92: Other biologics Immuno-oncology

    Lifecycle management Late-stage development Other biologics Early development - IMED Early development - MedImmune Immuno-oncology Compound Patient population Study phase Number of patients Design Endpoints Status PD-L1 Solid tumours Phase I/II N = 918 • Dose Escalation: 5 cohorts at Q2W and 1 • Saf

93. Slide 93: Durvalumab + Tafinlar/Mekinist Melanoma

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

94. Slide 94: Durvalumab + tremelimumab Solid tumours

    Lifecycle management Late-stage development Durvalumab (MEDI4736; PD-L1 mAb) Early development - IMED Early development - MedImmune + tremelimumab (CTLA-4 mAb) Solid tumours Patient population Study phase Number of patients Design Endpoints Status NSCLC Phase Ib N = 388 • Dose Escalation: minimum 5

95. Slide 95: MEDI0562 (OX40 agonist) Advanced malignancies

    Lifecycle management Late-stage development MEDI0562 (OX40 agonist) Early development - IMED Early development - MedImmune Advanced malignancies Patient population Study phase Number of patients Design Endpoints Status Advanced malignancies Phase I N = 50 Dose-escalation phase • Safety • FPD: Q1 15

96. Slide 96: MEDI6383 + durvalumab Advanced malignancies

    Lifecycle management Late-stage development MEDI6383 (OX40 agonist) + durvalumab Early development - IMED Early development - MedImmune (MEDI4736; PD-L1 mAb) Advanced malignancies Patient population Study phase Number of patients Design Endpoints Status Advanced malignancies Phase I N = 212 Dose-esc

97. Slide 97: MEDI0680 + durvalumab Advanced malignancies

    Lifecycle management Late-stage development MEDI0680 (PD-1 mAb) + durvalumab (MEDI4736) Early development - IMED Early development - MedImmune Advanced malignancies Patient population Study phase Number of patients Design Endpoints Status Advanced malignancies Phase I N = 150 Dose-escalation phase •

98. Slide 98: MEDI0562 (OX40 agonist) Advanced malignancies

    Lifecycle management Late-stage development MEDI0562 (OX40 agonist) Early development - IMED Early development - MedImmune Advanced malignancies Patient population Study phase Number of patients Design Endpoints Status Advanced malignancies Phase I N = 50 Dose-escalation phase • Safety • FPD: Q1 15

99. Slide 99: MEDI9447 + Durvalumab Advanced malignancies

    Lifecycle management Late-stage development MEDI9447 (CD73 mAb) + Durvalumab Early development - IMED Early development - MedImmune (MEDI4736; PD-L1 mAb) Advanced malignancies Patient population Study phase Number of patients Design Endpoints Status Advanced malignancies Phase I N = 132 Dose-escalat

100. Slide 100: MEDI1873 (GITR agonist) Solid tumours

     Lifecycle management Late-stage development MEDI1873 (GITR agonist) Early development - IMED Early development - MedImmune Solid tumours Patient population Study phase Number of patients Design Endpoints Status Adult subjects with select Phase I N = 42 Dose-escalation phase • Safety • FPD: Q4 15 adv

101. Slide 101: MEDI9197 (TLR7/8 agonist) Solid tumours

     Lifecycle management Late-stage development MEDI9197 (TLR7/8 agonist) Early development - IMED Early development - MedImmune Solid tumours Patient population Study phase Number of patients Design Endpoints Status Advanced solid tumour Phase I N = 45 Dose-escalation phase • Safety • FPD: Q4 15 malign

102. Slide 102: MEDI-551 (CD19 mAb) Haematological malignancies

     Lifecycle management Late-stage development MEDI-551 (CD19 mAb) Early development - IMED Early development - MedImmune Haematological malignancies Patient population Study phase Number of patients Design Endpoints Status Adults with relapsed or Phase II N = 170 • Arm 1: MEDI-551 dose level 1 and ICE

103. Slide 103: Other biologics Solid tumours

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

104. Slide 104: Other biologics Solid tumours

     Lifecycle management Late-stage development Other biologics Early development - IMED Early development - MedImmune Solid tumours Compound Patient population Study phase Number of patients Design Endpoints Status Anti-CEA BiTE Adults with Phase I N = 51 max • Dose-escalation (3+3), IV • MTD and safet

105. Slide 105: Other biologics Infections

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

106. Slide 106: Vaccine biologics Influenza vaccines

     Lifecycle management Late-stage development Vaccine biologics Early development - IMED Early development - MedImmune Influenza vaccines Compound Patient population Study phase Number of patients Design Endpoints Status MEDI3250 Children 2 to 6 years Phase III N = 100 • Open-label • Safety and tolera

107. Slide 107: MEDI1814 (amyloid beta mAb) Alzheimer's disease

     Lifecycle management Late-stage development MEDI1814 (amyloid beta mAb) Early development - IMED Early development - MedImmune Alzheimer’s disease Patient population Study phase Number of patients Design Endpoints Status Alzheimer’s disease & healthy Phase I N = 121 • SAD & MAD • Safety, tolerabilit

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