Nektar Therapeutics · NASDAQ:NKTR

Nektar Therapeutics — Technical Presentation (February 2023)

20 slides from Nektar Therapeutics's technical presentation, Feb 23, 2023

  1. Slide 1: Phase 2 ISLAND Study of REZPEG in SLE Topline Data Results

    Phase 2 ISLAND Study of REZPEG in SLE Topline Data Results February 23, 2023

  2. Slide 2: Forward-looking statements

    This presentation includes forward - looking statements regarding Nektar’s proprietary drug candidates, the timing of the start and conclusion of ongoing or planned clinical trials, the timing and outcome of regulatory decisions, unaudited year - end cash and investments and sufficiency of working c

  3. Slide 3: REZPEG Phase 2 ISLAND Study Schematic

    REZPEG Phase 2 ISLAND Study Schematic Treatment Follow - up Endpoints Primary • Percent who achieve a ≥4 - point reduction in SLEDAI index 2000 score Secondary • Percent who achieve SRI - 4 response • Percent who achieve BICLA response • Percent who achieve LLDAS • Characterize PK Randomization 1:1

  4. Slide 4: Prespecified criteria for secondary clinical endpoints

    • Primary endpoint (SLEDAI - 2K) was not chosen as critical success factor • No drug has been approved in lupus on SLEDAI - 2K • SRI - 4 endpoint used as basis for approval in 2011 • BICLA endpoint used as basis for approval in 2021 • Each dose level considered independently • Criteria: • SRI - 4: 1

  5. Slide 5: Definitions of SRI-4, BICLA, SLEDAI and LLDAS

    SRI - 4 (S ystemic Lupus Erythematosus Responder Index) 1 • SLEDAI: > 4 - point reduction from baseline • PGA: No worsening • BILAG: No worsening BICLA (British Isles Lupus Assessment Group - based Composite Lupus Assessment) 1 • SLEDAI: No worsening from baseline • PGA: No Worsening • BILAG: Improv

  6. Slide 6: ISLAND Phase 2 Protocol: Definition of Study Populations

    • Modified ITT: Randomized and received at least one dose of study medication • Modified ITT and BICLA Evaluable: Randomized, received at least one dose of study medication and had 1 BILAG A and/or 2 BILAG B at baseline • Per Protocol Population: All randomized patients who do not commit an Importan

  7. Slide 7: Study Populations

    ISLAND Phase 2 Study: Study Populations n (%) Placebo (n=74) REZPEG 300mcg (n=74) REZPEG 900mcg (n=70) REZPEG 1800mcg (n=73) REZPEG All Doses (n=217) Total (n=291) Modified Intent to Treat (mITT) 74 (100%) 74 (100%) 70 (100%) 73 (100%) 217 (100%) 291 (100%) Per Protocol (PP) 57 (77.0%) 58 (78.4%) 55

  8. Slide 8: Baseline Demographics

    Demographic Placebo (n=74) REZPEG 300mcg (n=74) REZPEG 900mcg (n=70) REZPEG 1800mcg (n=73) Age (yrs) 42 40 41 40 Female (%) 91% 93% 91% 93% BMI (kg/m 2 ) 27 26 26 27 Race (%) White 62% 60% 64% 67% Asian 22% 27% 20% 21% Black/African American 7% 8% 6% 4% Geographical Region (%)* Latin America 27% 27%

  9. Slide 9: REZPEG Country Enrollment

    Country, n Placebo (n=74) REZPEG 300mcg (n=74) REZPEG 900mcg (n=70) REZPEG 1800mcg (n=73) Total (n=291) Argentina 8 12 11 13 44 United States 9 14 9 11 43 India 10 12 8 8 38 Ukraine 10 8 7 10 35 Mexico 12 8 9 7 36 Japan 4 6 3 6 19 Poland 0 5 7 4 16 Puerto Rico 7 1 5 3 16 Romania 6 4 2 2 14 Other* 8

  10. Slide 10: Baseline Disease Characteristics

    10 Disease Characteristic Placebo (n=74) REZPEG 300mcg (n=74) REZPEG 900mcg (n=70) REZPEG 1800mcg (n=73) SLEDAI 2K Mean Score 9.9 9.7 9.1 9.9 SLEDAI - 2K < 10 42% 39% 59% 47% ≥ 10 58% 61% 41% 53% Mucocutaneous Involvement (Yes) 99% 99% 94% 100% Musculoskeletal Involvement (Yes) 97% 97% 96% 97% Renal

  11. Slide 11: Treatment Discontinuations

    11 Event, n (%) Placebo (n=74) REZPEG 300 mcg (n=74) REZPEG 900 mcg (n=70) REZPEG 1800 mcg (n=73) Discontinued 9 (12.2%) 18 (24.3%) 13 (18.6%) 29 (39.7%) Adverse Event 0 1 (1.4%) 6 (8.6%)** 10 (13.7%) Death 0 0 1 (1.4%) 0 Lack of Efficacy 0 2 (2.7%) 1 (1.4%) 0 Physician Decision 0 0 0 1 (1.4%) Withd

  12. Slide 12: Adverse Events Summary

    Event, n (%) Placebo (n=74) REZPEG 300 mcg (n=74) REZPEG 900 mcg (n=70) REZPEG 1800 mcg (n=73) Subjects with ≥1 Treatment Emergent Adverse Events (AEs) 21 (28.4%) 26 (35.1%) 29 (41.4%) 36 (49.3%) Treatment Emergent AEs occurring in ≥5% of subjects Any infections and infestations 22 (29.7%) 21 (28.4%

  13. Slide 13: PK/PD Observations

    • PK is approximately dose proportional over 300 to 1800mcg range and exposure levels are consistent with prior studies • Activated Treg increases observed in dose dependent manner consistent with prior studies • No changes to Tcon (CD4 and CD8) cells and consistent with prior studies • NK cell incr

  14. Slide 14: SLEDAI-2K: Primary Endpoint at Week 24

    50% 45% 40% 35% 30% 25% 20% 15% 10% 5% 0% p = 0.06 13.9% ∆ mITT PP 47.3% p = 0.309 8.8% ∆ 38.6% 33.3% 34.5% 32.7% 29.7% 29.7% 27.4% Placebo (n=74) (n=57) REZPEG 300mcg (n=74) (n=58) REZPEG 900mcg (n=70) (n=55) REZPEG 1800mcg (n=73) (n=52) SLEDAI - 2K: Primary Endpoint (mITT and PP) at Week 24 14 mIT

  15. Slide 15: BICLA Clinical Secondary Endpoint at Week 24

    >16% ∆ was achieved 32.2% 20.0% 35.4% 37.0% 24.4% 30.0% 30% 0% 10% 20% 40% 50% 60% Placebo (n=60) (n=48) REZPEG 300mcg (n=59) (n=46) REZPEG 900mcg (n=56) (n=44) REZPEG 1800mcg (n=60) (n=41) mITT PP 19.1% ∆ 54.5% 16.4% ∆ 46.4% 15 BICLA Clinical Secondary Endpoint at Week 24 19.2% of patients enrolled

  16. Slide 16: SRI-4 Clinical Endpoint at Week 24

    0% 5% 10% 50% 45% 40% 35% 30% 25% 20% 15% Placebo (n=74) (n=57) REZPEG 300mcg (n=74) (n=58) mITT PP 33.3% 34.5% 29.7% 29.7% 14.9% ∆ 47.3% 8.9% ∆ 38.6% 32.7% 27.4% REZPEG 900mcg (n=70) (n=55) REZPEG 1800mcg (n=73) (n=52) SRI - 4 Clinical Endpoint at Week 24 16 mITT: modified intent - to - treat; PP:

  17. Slide 17: Prespecified Criteria and REZPEG 900mcg Results

    • Primary endpoint (SLEDAI - 2K) was not chosen as critical success factor • No drug has been approved in lupus on SLEDAI - 2K • SRI - 4 endpoint used as basis for approval in 2011 • BICLA endpoint used as basis for approval in 2021 • Each dose level considered independently • Criteria: • SRI - 4: 1

  18. Slide 18: LLDAS Clinical Endpoint for mITT Population

    18 LLDAS Clinical Endpoint at 24 Weeks for mITT Population 0% 5% 35% 30% 25% 20% 15% mITT analysis was a 10% Placebo (n=74) (n=57) REZPEG 300mcg (n=74) (n=58) mITT PP 17.2% 15.8% 14.9% 13.5% 15.1% ∆ 30.9% 12.2% ∆ 25.7% 19.2% 16.4% REZPEG 900mcg (n=70) (n=55) REZPEG 1800mcg (n=73) (n=52) mITT: modifi

  19. Slide 19: Activity of 900 mcg on Multiple Endpoints at Week 24

    12.2% 8.8% 16.4% 12.8% 15.2% 9.2% 14.5% 36.4% 0% 5% 10% 15% 35% 30% 25% 20% 40% LLDAS (n=70) SRI - 4 (n=70) BICLA (n=56) BILAG Joints SLEDAI Joints (n=61) (n=67) SLEDAI Arthritis & Rash Remission (n=70) BILAG Skin (n=57) CLASI - 50 (n=11) Demonstrated Activity of 900 mcg on multiple endpoints in mIT

  20. Slide 20: Q&A Session

    Q&A Session NEW PATHWAYS TO SMARTER MEDICINE”

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