Nektar Therapeutics · NASDAQ:NKTR
Nektar Therapeutics — J.P. Morgan Healthcare Conference 2014
23 slides from Nektar Therapeutics's conference presentation, Jan 21, 2014
Slide 1: J.P. Morgan Healthcare Conference, January 14, 2014
Exhibit 99.1 January J.P. 2014 Howard President Morgan Healthcare 14, Robin & 2014 CEOConference
Slide 2: Forward-looking statements
This presentation potential. obligation Actual to update results includes forward-looking could forward-looking differ materially statements statements and as athese result regarding statements of newNektar’s information are subject technology or to otherwise. important platform, risks drug detailed
Slide 3: Nektar Well-Positioned with Proven Technology Platform and Drug Candidates
3Bayaer Nektar Well-Positioned Amikacin Phase REG1 Fovista™ BAX Filed NKTR-102 In Naloxegol Development Wholly-Owned Neuropathic Completed Candidates NKTR-181 Chronic Research Preclinical Programs NKTR-174 Nociceptive Could Phase US, 855 3/Filed 3 Generate Therapeutics: Fovista Enrollment Pain 3Canc
Slide 4: Naloxegol (NKTR-118): Once-Daily Oral Tablet to Treat Opioid-Induced Constipation
Naloxegol Potential NDA, scheduled) Nektar 4Photo of MAA eligible an to(NKTR-118): AZ be investigational andFirst responsible forNDS upOnce-Daily to: filings $175 for product accepted all million Oral development, candidate Tablet in in regulatory/launch US,toEU Treat regulatory andOpioid-Induced Ca
Slide 5: Opioid-Induced Constipation: High Unmet Need
*5(2009) Opioid-Induced High $14.8 Of majority 69 In 28—35 Approximately these Million theUnmet Billion $14.8 SOURCE:1.Million five Number ofPharmacology. Dysfunction: Approach. Patients prescribers 11-17.markets, Medical billion IMS40-50% Patients Constipation: of patients global Need there in(28-3
Slide 6: Naloxegol Positive Phase 3 Efficacy Results
6Source: Naloxegol Positive Achieved p=0.001 Proportion 29.4% 39.7% 44.4% High p=0.002 50% 31.4% 46.8% 48.7% Placebo KODIAC-04 45% Responder 29.3% 28.8% Chey Naloxegol Results p=0.021 p=0.014 Primary 40% (NKTR-118): of KODIAC-05 Responders et.35% from Rate al., Endpoint Placebo 30% DDW in Phase Pati
Slide 7: Naloxegol: Percent of Patients with SBM in First 24 Hours
7Source: Naloxegol: Percent 75% 36.9% 35.8 70.1% 5.9 Placebo 36.6% 37.2 Naloxegol 61.2% Hours 12.0 KODIAC-04 KODIAC-05 60%of Chey n=214 n=232 45% Patients 25mg Key p<0.001 et.30% Secondary al., n=214 n=232 with 15% DDW vs.SBM 0% placebo May Endpoint In 2013 FirstMet 24 Hours Median Time to First Pos
Slide 8: Naloxegol: Large, Positive Long-Term 52-Week Safety Study
8Naloxegol: Large, 534 270 Most 2adverse No Prospective ACG MACE reports patients common 2013; well-controlled, events, events of Positive Photo assessment –opioid naloxegol usual GI-related including outofResults care of withdrawal an270 534 52-week, of investigational 25 AEs major opioid patients
Slide 9: BAX 855 Longer-Acting Therapy for Hemophilia A
9BAX Longer-Acting ~150 Therapy BAX U.S. Nektar Up Significant Source: Baxter: Key Recombinate/ Pfizer $2B Advate® Kogenate® Bayer Helixate® toFactor CSL regulatory patients 855: 855 $84 entitled The Deutsche well-tolerated Behring is achieved million royalties VIII Clear designed Refacto/ ADVATE® t
Slide 10: Amikacin Inhale: Targeted Gram-Negative Pneumonia Therapy
Amikacin Bayer Targeted 65% IV SPA Primary Nektar 30% 22% 1Estimated 2010 10Gram-negative therapies in of U.S. average ventilated Phase place royalties ICU endpoint: delivery flat Inhale global pneumonias can’t 3for ex-U.S. royalty Program patients on Phase (BAY41-6551): Niederman market: of reach c
Slide 11: NKTR-102: Phase 3 BEACON Study in Previously Treated Patients
NKTR-102 11 Patients Previously Arm 1:1 Randomized Single Treatment Physician’s Primary Overall Secondary PFS Agreement BEACON FinalCBR A: topline Agent Survival with Endpoint ORR of study Endpoints treated with Passes Choice Arm survival metastatic NKTR-102 DoR FDA completed (OS) B: with Interim (T
Slide 12: NKTR-102 Glioma: Limited Data Exceeded Primary Endpoint
NKTR-102 12 Glioma Limited 6-Week 50% As Mature Preliminary ofofJanuary PFS patients is PFS data one Exceeded data and of and 2014, of25% achieved OS provided the limited data two most was Primary patients survival to needed stable deadly bybeStanford Endpoint submitted disease to still cancers inre
Slide 13: NKTR-102 Anti-Tumor Synergy with PARP Inhibitor in BRCA1 Deficient Model
Anti-Tumor 13 BRCA1 All Combination MX-1 2000 Vehicle nKTR-102 Treatment 1/10animals tumor 1500 Breast NKTR-102 Deficient start 1000 10 free tumor-free Synergy treatment Cancer mg/kg PARP-X 10/10 500+0Model of i.v., PARP-X tumor 0by very NKTR-102 7qdx21 q7dx4 14 14in well free days 21 mice, PARP-X N
Slide 14: NKTR-181: New Molecule for Chronic Pain
Global Antidepressants Opioids NSAIDs/COX-2s Chronic New NKTR-181: NKTR-181 Reduce Long-acting Properties Received Source: 14 Opioid Chronic abuse drowsiness respiratory IMS $12.6B pain back Fast inherent designed profile Molecule MIDAS; market pain liability Track Pain Antiepileptics $5.9B Osteoart
Slide 15: NKTR-181 Enters the Brain Slowly to Reduce Euphoria
15 Minutes Oxycodone 11 NKTR-181 Plasma 2.9 Pupil Reduced Source: equilibration Hours Constriction to Concentration 2)Euphoria CNS Nektar Enters siteEquilibration2 Equilibration1 equilibration 1) the and Therapeutics, Brain Low Abuse Slowly half-life); Kharash Liability to Reduce half-life) et. of a
Slide 16: NKTR-181 Enriched Enrollment Randomized Withdrawal Design
716 Screening NKTR-181 Enriched 6of Enrollment 40% Average 6.8 Only 3.9 Baseline Titration 5 Significantly Randomization (46% 3% 4 Decrease reduction3 from21-day 3.7 patients Withdrawal couldReduced Double-blind screening) All not PatientsDesign Pain titrate Scores n=213 Period (EERW)During to effec
Slide 17: NKTR-181 Did Not Show Rebound with Placebo Arm
176 5 4reduction 7Enriched NKTR-181 4.0 Placebo 3.9 4.1 6.8 (46% Screening 3Arm Enrollment Titration 3.7 Didfrom Not 21-day Withdrawal screening) Rebound Double-blind Design Period (EERW)Period Placebo-controlled Period
Slide 18: Reasons for EERW Design With NKTR-181
Reasons 18 EERW With pain Subjects NKTR-181 This WOMAC Pain Source: scores. reduction scores typical design Leber for were pain collected drop-out provided Lack opioids, allowed not adopted and at subscale time of optimal Davis, Placebo rate strong patients inof tothe israndomization for continue st
Slide 19: NKTR-181: Next Steps Following FDA Guidance
Nextrequirement 19 Guidance Highly Track First Parallel No NKTR-181 Recommend Phase Step Status productive design from for 3iscontinued study NKTR-181: clearly suitable FDA to initial use can and anEERW be development for analgesic meeting Key started pivotal Pain for this registration with with reg
Slide 20: Proposed Phase 3 Pivotal Study Design in Osteoarthritis Pain
Proposed 20 Blinded 12 Patients Randomized Primary Placebo NKTR-181 WOMAC Change Eliminate Endpoint Specific Pain Interim Week scores futility from Titration with Endpoint: scale Treatment agreed Parallel continued Pain collected 1:1 osteoarthritis Baseline designed analysis Subscale toto Design by
Slide 21: Acute Pain Programs: NKTR-192
Acute 21 Phase NKTR-192 sedation Injectable metabolism and partial 1Pain Multiple-Ascending and formulation mu-opioid Programs demonstrated dizzinessagonist of andNKTR-192 significant noDose molecules reports Study and to of be euphoria for rapid explored NKTR-192 analgesic or in elevated preclinica
Slide 22: NKTR-171: First Peripherally-Restricted Sodium Channel Blocker for Neuropathic Pain
First 22 Gabapentinoids Peripherally-restricted pNKTR-171: = Source: Global $100M Lyrica® Cymbalta® gabapentin Off-label otentSubjects analgesia Sales Opioids Datamonitor, $1,200M antidepressants antiepileptics $600M ofDosed Neuropathic widely $400M with $2,100M In low Jan sodium $200M used Phase 20
Slide 23: Nektar Catalysts 2014 and Beyond
Nektar Ended NOTE: FDA Mar. BAX Cipro Regado 2nd Ph NKTR-102 Amikacin NKTR-171 2017 NDA Planned Fovista US Potential NKTR-181 3Approval & Ph Interim/ Data 10-11, Amikacin Panel Filling 855 Inhale EU 2013 Catalysts 3Partnered Planned Ph REG1 US Start Approval Potential Inhale NKTR-181 2016 3in Ph2 Ph
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