Nektar Therapeutics · NASDAQ:NKTR
Nektar Therapeutics — 2017 JP Morgan Healthcare Conference
28 slides from Nektar Therapeutics's conference presentation, Jan 10, 2017
Slide 1: 2017 JP Morgan Healthcare Conference
2017 JP Morgan Healthcare Conference Howard W. Robin President & CEO January 10, 2017
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, future availability of clinical trial data, and royalty and milestone re
Slide 3: Building a Biopharmaceutical Growth Company
Building a Biopharmaceutical Growth Company Wholly-Owned Research & Revenue Drivers Integrated R&D, Scale-Up Development Pipeline Partnered Portfolio and Manufacturing Capabilities Immuno-Oncology NKTR-214 Multiple Tumor Types Combination Trials $375-450M NKTR-255 Annual Revenue IL-15 By 2021 R&D Ce
Slide 4: Revenue from Partnered Programs Supports Growth of Nektar
Revenue from Partnered Programs Supports Growth of Nektar $375 - 450M Annual Revenue By 2021 PEGPH20 (Halozyme) Amikacin Inhale (Bayer) Cipro DPI (Bayer) Milestone Potential Royalty And Onzeald (EU only) (Daiichi Sankyo) (Shire) (AstraZeneca) 2017 2019 2021 Does not include US revenue for Onzeald. C
Slide 5: NKTR-181: A Novel Opioid Poised to Transform the Chronic Pain Market
NKTR-181: A Novel Opioid Poised to Transform the Chronic Pain Market $20 Billion+ Global Chronic Pain NKTR-181 brings unique properties Therapy Market to the treatment of chronic pain: Slow rate of entry into CNS designed to Antidepressants Antiepileptics $1.5B $3.6B reduce euphoria and resulting
Slide 6: NKTR-181 Development Strategy
NKTR-181 Development Strategy Q1 2017 Q2 2017 Q3 2017 Initiate Partnering Discuss early NDA filing based Efficacy Study Ongoing in Opioid-naïve Patients with Discussions upon efficacy and HAL trial results Chronic Low Back Pain Q2 2017 Topline Data 2H 2017 March 2017 Long-term (52-wk) safety study I
Slide 7: The Immunity Cycle and Multiple Points of Intervention for I-O Therapies
The Immunity Cycle and Multiple Points of Intervention for I-O Therapies 4. Trafficking of T cells to tumor 3. Priming and 5. Infiltration activation of T cells into tumors 2. Cancer antigen 6. Recognition presentation of cancer cells by T cells 7. Killing of 1. Release of cancer cells cancer cell a
Slide 8: Nektar's Immuno-Oncology Strategy to Create Therapies that Cover the Immunity Cycle
Nektar’s Immuno-Oncology Strategy to Create Therapies that Cover the Immunity Cycle 4. Trafficking of T cells to tumor (CTLs) 3. Priming and 5. Infiltration of T activation cells into tumors Target as (APCs & T cells) (CTLs, endothelial cells) many steps as Therapies possible in the need to be cycle
Slide 9: Nektar's Immuno-Oncology Strategy to Create Therapies that Cover the Immunity Cycle
Nektar’s Immuno-Oncology Strategy to Create Therapies that Cover the Immunity Cycle 4. Trafficking of T cells to tumor (CTLs) NKTR-214 (CD122 Agonist) 3. Priming and Prime, Proliferate, Activate & activation Increase Tumor-Infiltrating 5.cells Infiltration of T into tumors Target as (APCs & T cells)
Slide 10: IL-2 is Master Growth Factor for T Cells and NK Cells
IL-2 is Master Growth Factor for T Cells and Natural Killer (NK) Cells Native IL-2 has pleiotropic effects on the IL-2 immune response rhIL-2 protein therapy (aldesleukin) requires high and frequent dosing b CTLs Tregs ab in ICU which results in CD8+ T-Cells CD4+ Regulatory T-Cells severe side
Slide 11: NKTR-214: Biasing Action to CD122 to Stimulate T-Cell Production
NKTR-214: Biasing Action to CD 122, or IL-2R Beta, to Stimulate T-Cell Production Biases signaling to favor the CD122 Receptor (IL- NKTR-214 2Rβγ complex) Eliminates over-activation of IL-2 pathway that results in serious safety b CTLs Tregs ab issues CD8+ T-Cells CD4+ Regulatory T-Cells and N
Slide 12: NKTR-214 Selectively Grows T Cells, NK Cells in Tumor Microenvironment
NKTR-214 Selectively Grows T Cells, NK Cells Tumor Microenvironment in Cancer Patients Analysis of T cell Populations in Tumor NKTR-214 drives immune activation in the tumor • Increase in total T cells, NK 440 and CD8 T cells 0 29.8 • No increase in Tregs 330 0 • Increase in PD-1 positive CD8 T ce
Slide 13: BMS and Nektar Clinical Collaboration for NKTR-214 and Opdivo
BMS and Nektar Clinical Collaboration for NKTR-214 and Opdivo® • BMS is global leader in immuno-oncology • BMS and Nektar collaborating exclusively on anti-PD1 and IL- 2-based mechanisms • Companies to conduct Phase 1/2 development of NKTR-214 and Opdivo in eight or more cancer indications • BMS and
Slide 14: PIVOT Program: NKTR-214 plus Opdivo with Eight Expansion Cohorts Planned
PIVOT Program: NKTR-214 plus Opdivo® with Eight Expansion Cohorts Planned PIVOT-02 PIVOT-04 Phase 1 Dose Escalation Phase 2 Expansion Cohorts (on label indications) Q2 2017 N= 20-30 Melanoma 1st line, N=28 Melanoma 1st line Melanoma 2nd line I-O relapsed, N=26 Renal Cell Carcinoma Renal Cell Carcino
Slide 15: NKTR-214 Provides A Central Mechanism to Combine with Multiple Modalities
NKTR-214 Provides A Central Mechanism to Combine with Multiple Modalities in Immuno-Oncology Checkpoint Inhibitors Vaccines Cell Therapies (TIL therapy, ECT) NKTR-214: T Cell Growth Factor Small Molecules (TLR Agonist, other targets) 15
Slide 16: NKTR-214: Additional Development Programs in 2017
NKTR-214: Additional Development Programs in 2017 Initiate triplet combination trial of NKTR-214 with anti-PD-1 and anti-CTLA-4 agents Checkpoint Inhibitors Initiate IST in Sarcoma with NKTR-214 and Opdivo® at Memorial Sloan Kettering and MD Anderson Initiate Phase 1 trial of NKTR-214 and anti-PD-L1
Slide 17: Nektar's Immuno-Oncology Strategy to Create Therapies That Cover the Immunity Cycle
Nektar’s Immuno-Oncology Strategy to Create Therapies That Cover the Immunity Cycle 4. Trafficking of T cells to tumor (CTLs) NKTR-214 (CD122 Agonist) 3. Priming and Prime, Proliferate, Activate & activation Increase Tumor-Infiltrating 5.cells Infiltration of T into tumors Target as (APCs & T cells)
Slide 18: NKTR-255: Stimulates Memory T Cell and NK Cell Activation
NKTR-255: Stimulates Memory T Cell and NK Cell Activation IL-15 delivers T-cell survival signal, promotes CD8 memory cell formation and activates Natural Killer (NK) cells with NKTR-255 is first minimal CD4 activity potential medicine to • Short half-life of native IL-15 access the IL-15 requires
Slide 19: NKTR-255 Induces Sustained Signaling and Cell Proliferation In Vivo
NKTR-255 Induces Sustained Signaling and Cell Proliferation In Vivo IL-15 NKTR-255 Single dose of NKTR-255 sustains NK and CD8 cell activation and proliferation for more than 3 days Effect of NKTR-255 also observed on both effector memory and central memory CD8 cells Mice received a single i.v.
Slide 20: Nektar's Immuno-Oncology Strategy to Create Therapies that Cover the Immunity Cycle
Nektar’s Immuno-Oncology Strategy to Create Therapies that Cover the Immunity Cycle 4. Trafficking of T cells to tumor (CTLs) NKTR-214 (CD122 Agonist) 3. Priming and Prime, Proliferate, Activate & activation Increase Tumor-Infiltrating 5.cells Infiltration of T into tumors Target as (APCs & T cells)
Slide 21: NKTR-262: Adding a Unique Intratumoral TLR Agonist to Nektar's I-O Portfolio
NKTR-262: Adding a Unique Intratumoral TLR Agonist to Nektar’s Immuno-Oncology Portfolio M1 Dendritic TLR agonists activate innate Macrophage Cell immunity, myeloid cell response and increase tumor antigen presentation NKTR-262 • Creates tumor-suppressing micro- activates environment by mimicking
Slide 22: Complete Regression and Abscopal Effect with Combination of NKTR-262 and NKTR-214
Complete Regression and Abscopal Effect with Combination of NKTR-262 and NKTR-214 Primary (injected) CT-26 Colon Tumor Dosing Primary (injected) Tumor 1000 SEM ) NKTR-262 Vehicle NKTR-214 3 T u m o r V o lu m e (m m 500 Secondary (non-injected) Tumor D0 D9 D 18 NKTR-214 NKTR-262 NKTR-262 + NKTR-21
Slide 23: Auto-Immune Disease is Characterized by Imbalance of T-Reg Cells to T-Effector Cells
Auto-Immune Disease is Characterized by Imbalance of T-Reg Cells to T-Effector Cells • Current auto-immune disease therapies work Pathological overpopulation of by suppressing overall Beneficial effector T cell antigen-specific immune system function (self-reactive) population effector T cells – Tre
Slide 24: NKTR-358: Growing the Body's Own Population of T-Reg Cells
NKTR-358: Growing the Body’s Own Population of T-Reg Cells to Treat Auto-Immune Disease What if you could grow the body’s own population of T- reg cells and directly treat the underlying disease pathology? Restore balance and normalize T-reg cell and T- effector cell function 24
Slide 25: NKTR-358 is Selective for Enhancing T-Reg Proliferation in Non-Human Primates
NKTR-358 is Selective for Enhancing of T-Reg Proliferation and Activation in Non-Human Primates Fold Change in Treg and Teff T-Reg Activation Markers Treg Teff Dosing Dosing • Single dose NKTR-358 produced greater Treg expansion than repeat low-dose IL-2 • In mice, NKTR-358 treatment promotes >30-fo
Slide 26: NKTR-358 Suppresses Antigen-Driven Inflammation in Preclinical Model
NKTR-358 Suppresses Antigen-Driven Inflammation in Preclinical Model of Cutaneous Hypersensitivity Sensitization (KLH flank) Elicitation in ear (with KLH) Measure ear swelling Day 0 Day 5 Cutaneous Hypersensitivity Response 16 (m m , m e a n S E M ) 14 12 V e h ic le 10 N K T R - 3 5 8 , 0 .0 0 3
Slide 27: NKTR-358: Phase 1 Clinical Development in Lupus and GVHD
NKTR-358: Phase 1 Clinical Development in Lupus and GVHD Q1-Q3 2017 Q3 2017 Phase 1 Initiate Phase 1b Single Ascending Dose Trial in Multiple Ascending Dose Trial in Healthy Subjects Lupus (SLE) Patients Single SQ Dose of NKTR-358 Multiple SQ Doses of NKTR-358 (n ~50) (n ~50) • 3:1 randomization vs.
Slide 28: 2017 Anticipated Milestones
2017 Anticipated Milestones First Half of 2017: • Topline data from second Cipro DPI Phase 3 efficacy trial in bronchiectasis (Partner Bayer) • CHMP opinion regarding conditional market authorization for ONZEALD in Europe (Partner Daiichi Sankyo)(March) • Topline data from NKTR-181 Phase 3 efficac
Nektar Therapeutics — 2017 JP Morgan Healthcare Conference on 6ix