Nektar Therapeutics · NASDAQ:NKTR
Nektar Therapeutics — J.P. Morgan 2015 Healthcare Conference
27 slides from Nektar Therapeutics's conference presentation, Jan 13, 2015
Slide 1: J.P. Morgan 2015 Healthcare Conference
J.P. Morgan 2015 Healthcare Conference Howard Robin President & CEO January 13, 2015
Slide 2: Forward-looking statements
This presentation includes forward-looking statements regarding Nektar’s technology platform, drug candidates, clinical and regulatory objectives, market opportunity estimates, and royalty and milestone payment potential. Actual results could differ materially and these statements are subject to imp
Slide 3: Building a Growth-Oriented Biopharmaceutical Company
Building a Growth-Oriented Biopharmaceutical Company Efficient R&D Robust Pipeline Proven Commercial & Organization & of Drug Technology Filed Products Manufacturing Candidates Platform Capabilities 2 key products 6 clinical stage 425 employees Creates new approved or filed drug candidates worldwide
Slide 4: Movantik (naloxegol) Tablets: First Once-Daily Oral Tablet to Treat OIC
Movantik™ (naloxegol) Tablets: First Once-Daily Oral Tablet to Treat Opioid-Induced Constipation FDA approval on September 16, 2014 • Decontrol process near completion • AstraZeneca planning U.S. launch in late Q1 / early Q2 2015 www.movantik.com • Treat adult patients with chronic, non-cancer pai
Slide 5: PAMORA Target the Underlying Cause of OIC
Peripherally-Acting Mu-Opioid Receptor Antagonists (PAMORA) Target the Underlying Cause of OIC Opioid PAMORA mu-opioid receptor mu-opioid receptor Opioids effective for PAMORA targets analgesia also act on mu-opioid receptors receptors in the GI tract throughout GI tract causing dysmotility to direc
Slide 6: Phase 3 Data Published in New England Journal of Medicine
Phase 3 Data Published in New England Journal of Medicine (NEJM) 25 mg naloxegol dose met primary endpoint of responder rate 25 mg naloxegol dose also met all secondary endpoints 5.9 Hours 75% 12.0 Hours 70.1% with SBM In First 24 Hours 60% 61.2% Percent of Patients 35.8 37.2 45% Hours Hours 30% 36.
Slide 7: U.S. OIC Patient Population
U.S. OIC Patient Population 38M Chronic, Non-Cancer Pain Patients on Opioid Regimens 38M chronic, non-cancer pain U.S. Opioid Prescribers patients taking opioids in the by Specialty U.S. • A common side effect is constipation • At least half do not benefit Pain Primary Care Specialists from existi
Slide 8: AstraZeneca Commercial Launch in U.S.
AstraZeneca Commercial Launch in U.S. Commercial launch planned for late Q1 2015 / early Q2 2015 www.movantik.com Direct-to-consumer efforts will be employed to reach the high number of patients in need of relief Significant personal selling efforts will be deployed to the universe of prescrib
Slide 9: NKTR-102: A New Topoisomerase I-Inhibitor
NKTR-102: A New Topoisomerase I-Inhibitor NKTR-102 is a novel topoisomerase I inhibitor with an optimized PK profile • 50-day half-life allows continuous tumor exposure • Enhanced Permeability and Retention (EPR) effect results in high tumor concentrations • Molecule designed to reduce peak exposu
Slide 10: NKTR-102: New Mechanism of Action to Treat Metastatic Breast Cancer
NKTR-102: New Mechanism of Action to Treat Metastatic Breast Cancer Annual Treatments in US and EU-5:1 62,000 38,000 26,000 Second Line Third Line Fourth Line Most capecitabine Halaven Halaven Common Abraxane® gemcitabine capecitabine Halaven® capecitabine gemcitabine Mechanism: gemcitabine vinorelb
Slide 11: NKTR-102: Completing Phase 3 Pivotal BEACON Study
NKTR-102: Completing Phase 3 Pivotal BEACON Study Primary Endpoint Randomized 1:1 Patients with Arm A: Single Agent NKTR-102 Overall Survival (OS) metastatic breast cancer Secondary Endpoints Previously treated with A/T/C Arm B: Treatment of PFS CBR (n=852) Physician’s Choice (TPC) ORR DoR
Slide 12: NKTR-102: Beyond Breast Cancer
NKTR-102: Beyond Breast Cancer Glioblastoma • IST Phase 2 Study Complete • 15% ORR in Avastin-refractory patients Non-small Cell Lung Cancer • IST Phase 2 Study Ongoing Pediatric Tumors • Pediatric Oncology Division and Pediatric ODAC interest in Ewing’s Sarcoma, High-Grade Glioma & Neuroblast
Slide 13: Anti-Tumor Synergy of NKTR-102 with Clovis' Rucaparib
Anti-Tumor Synergy of NKTR-102 in Combination with Clovis’ Rucaparib Presented at 2014 EORTC MX-1 Breast Cancer Model BRCA1 Deficient All animals tumor-free by 14 days following treatment with NKTR-102 in combination with rucaparib Combination treatment very well tolerated with no body weight lo
Slide 14: BAX 855: Longer-Acting ADVATE for Hemophilia A
BAX 855: Longer-Acting ADVATE® for Hemophilia A BAX 855 is designed to expand Baxter’s leadership position as a longer-acting therapy based upon ADVATE, the gold standard Projected Growth in Factor VIII Market All Factor VIII Products treatment for hemophilia A 8.0 $7.6B BAX 855 achieved target
Slide 15: Nektar-Bayer Anti-Infective Programs in Phase 3
Nektar-Bayer Anti-Infective Programs in Phase 3 Both products granted Qualified Infectious Disease Product (QIDP) Designation from FDA • Eligible for fast-track, priority review, and 5-year extension of market exclusivity Drug-device products designed to target antibacterial therapy deep into th
Slide 16: NKTR-181: New Opioid Molecule for Chronic Pain Entering Phase 3
NKTR-181: New Opioid Molecule for Chronic Pain Entering Phase 3 NKTR-181 designed to target Global Chronic Pain Therapy Market chronic pain market with a novel opioid: Antidepressants Antiepileptics $1.5B Slow rate of entry into CNS $3.6B designed to reduce abuse liability Opioids $12.6B Plasma
Slide 17: NKTR-181 Enters the Brain Slowly
Human Studies Demonstrate that NKTR-181 Enters the Brain Slowly Oxycodone NKTR-181 Plasma to CNS Equilibration1 Plasma to CNS Equilibration2 Plasma Concentration Plasma Concentration Pupil Constriction Pupil Constriction 2.9 Hours Plasma Drug 11 Minutes Concentration Pupil Constriction Slow brain en
Slide 18: Clinical Results for NKTR-181 To-Date
Clinical Results for NKTR-181 To-Date Demonstrated slow rate of entry into the CNS as shown by pupillometry Magnitude of pupil constriction consistent with efficacious doses of long-acting opioids Results of Phase 2 EERW efficacy study • During titration phase, 40% reduction in pain scores wit
Slide 19: First Phase 3 EERW Study in Chronic Lower Back Pain
First Phase 3 EERW Study in Patients with Chronic Lower Back Pain 2 – 7 weeks 21 days 12 weeks Including ≥ 1 week at stable dose PLACEBO (n=208) 100 200 300 400 Baseline Patient 1:1 Randomization Screening NKTR-181 BID (mg) NKTR-181 (n=208) Adequate and Sustained Primary Key Secondary Patients w/ Pa
Slide 20: First Phase 3 EERW Study in Chronic Lower Back Pain
First Phase 3 EERW Study in Patients with Chronic Lower Back Pain 2 – 7 weeks 21 days 12 weeks Including ≥ 1 week at stable dose PLACEBO (n=208) 100 200 300 400 Baseline Patient 1:1 Randomization Screening NKTR-181 BID (mg) NKTR-181 (n=208) Adequate and Sustained Primary Key Secondary Patients w/ Pa
Slide 21: NKTR-181: Additional Studies in Phase 3 Program
NKTR-181: Additional Studies in Phase 3 Program Second efficacy study in opioid-experienced patients with chronic low back pain A long-term (52-week) safety study Human abuse liability (HAL) program to support abuse deterrent labeling and less restrictive scheduling 21
Slide 22: IL-2 Receptor is an Attractive Cancer Target
IL-2 Receptor is an Attractive Cancer Target but Has Pleiotropic Opposing Effects IL-2 IL-2 βγ CTLs Tregs αβγ IL-2R CD8+ Memory T-Cells CD4+ Regulatory T-Cells Stimulates Immune Suppresses Response to Kill Immune Response Structure of the human IL-2/Rαβγ Tumor Cells quaternary signaling complex.1 1.
Slide 23: NKTR-214: Receptor Selective Positive Effects on Tumor Killing Cells
NKTR-214: Receptor Selective – Positive Effects on Tumor Killing Cells NKTR-214 NKTR-214 βγ CTLs Tregs αβγ IL-2R CD8+ Memory T-Cells CD4+ Regulatory T-Cells Stimulates Immune Suppresses Response to Kill Immune Response Polymer blocks IL-2/IL-2Rα interaction Tumor Cells Lower and less frequent dosi
Slide 24: NKTR-214 in Combination with Anti-CTLA-4
NKTR-214 in Combination with Anti-CTLA-4: Long-term Immunity in Mouse Model Following Multiple Tumor Rechallenges TREATMENT PERIOD NO ADDITIONAL TREATMENT Control 2nd Tumor Implant into CR Mice 3rd Tumor Implant into Tumor Free Mice Treated 44% Complete Responses (CR) Anti-CTLA-4 + NKTR-214* Rechall
Slide 25: Nektar R&D Pipeline
Nektar R&D Pipeline Program Preclinical Phase 1 Phase 2 Phase 3 Filed Approved MOVANTIK™(naloxegol) (OIC) FDA/EU Approved Late-Stage / Filed BAX 855 (Hemophilia A) BLA Filed December 2014 NKTR-102 (Breast Cancer) Phase 3 Topline Data in Q1 2015 Amikacin Inhale (Ventilator Pneumonia) Ciprofloxacin DP
Slide 26: 2015 Milestones
2015 Milestones Ended 2014 with $262.8M cash February Start of enrollment for Phase 3 study of NKTR-181 March Topline data for Phase 3 BEACON study of NKTR-102 U.S. commercial launch of MOVANTIK™ Q1 / Q2 ($100 million milestone to Nektar) EU commercial launch of MOVENTIG® Q2 ($40 million milestone t
Slide 27: J.P. Morgan 2015 Healthcare Conference
J.P. Morgan 2015 Healthcare Conference Howard Robin President & CEO January 13, 2015
Nektar Therapeutics — J.P. Morgan 2015 Healthcare Conference on 6ix