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Nektar (NKTR) Continues Charge Forward With ‘181 & ‘214 Leading The Way

Nektar

March 2, 2018

On the recent Q4 conference call, NKTR provided updates for both ‘181 and ‘214.  The company has had two positive pre-NDA meetings with the FDA over the last two months regarding ‘181.  One very important aspect discussed with the agency is a better abuse scheduling for ‘181 given its non-addictive properties than a Schedule 2 which is currently used for addictive opioids.  ‘181 will be filed for FDA approval in Q2 with a filing package that includes data from 2,100 patients.  NKTR is in active negotiations with potential partners for ‘181, given the excellent terms for both the BMS and Lilly deals, we expect the same for ‘181.  ‘214 is poised for very broad development with BMS now on board.  The first two registrational combo trials will be in front line melanoma and kidney cancer (RCC).  While BMS is going gang busters in ‘214 combo development, NKTR still retains control of ‘214 in combination with any other I/O drug candidates.  The company is clearly going to strike more ‘214 partnerships in 2018 as they believe it can be the backbone I/O drug for many different tumor types.  NKTR also reported that the ‘214 data reported at JP Morgan has improved again with the response rate in RCC up to 71%.

The company announced upcoming presentations at the following scientific congresses during the first half of 2018:

American Association for Cancer Research (AACR) Annual Meeting 2018, Chicago, IL:

Abstract 3755/Poster 5: Comprehensive antitumor immune activation by a novel TLR7/8 targeting agent NKTR-262 combined with CD122-biased immunostimulatory cytokine NKTR-214“, Kivimae, S., et al.

o    Session: Immunology: Immunomodulatory Agents and Interventions 1

o    Session Date and Time: Tuesday, April 17, 2018, 8:00 a.m. – 12:00 p.m. Central Time

o    Location: McCormick Place South, Exhibit Hall A, Poster Section 32

Abstract 2755/Poster 17: “NKTR-262: Prodrug pharmacokinetics in mice, rats, and dogs“, Lee, M., et al.

o    Session: Immunology: Immune Mechanisms Invoked by Therapies 1

o    Session Date and Time: Monday, April 16, 2018, 1:00 p.m. – 5:00 p.m. Central Time

o    Location: McCormick Place South, Exhibit Hall A, Poster Section 33

Abstract 123/Poster 13: “Enhanced anti-tumor activity of the combination of entinostat and NKTR-214 in renal and colon cancer tumor models“, Wang, L., et al.

o    Session: Tumor Biology: Role of the Innate Immune System in Tumorigenesis

o    Session Date and Time: Sunday, April 15, 2018, 1:00 p.m. – 5:00 p.m. Central Time

o    Location: McCormick Place South, Exhibit Hall A, Poster Section 5

Abstract 3566/Poster 4: “Enhanced expansion and tumor targeting of adoptively transferred T cells with NKTR-214“, Parisi, G., et al.

o    Session: Clinical Research: Adoptive Cell Therapy 3

o    Session Date and Time: Tuesday, April 17, 2018, 8:00 a.m. – 12:00 p.m. Central Time

o    Location: McCormick Place South, Exhibit Hall A, Poster Section 24

Antigen-Specific Immune Tolerance Drug Development Summit 2018, Boston, MA:

Preclinical Data Presentation: “NKTR-358: A Selective Regulatory T Cell Inducing Agent for the Treatment of Autoimmune and Inflammatory Diseases”

o    Presenter: Jonathan Zalevsky, Ph.D., Nektar Therapeutics

o    Date and Time: Wednesday, April 25, 2018, 4:20 p.m. Eastern Time
American Academy of Pain Medicine 34th Annual Meeting, Vancouver, BC:

Poster: “Efficacy, safety, and tolerability of NKTR-181 in patients with moderate to severe chronic low-back pain: A Phase 3 study”

o    Presenter: John Markman, M.D., University of Rochester Medical Center

o    Session: Poster Session 2

o    Date and Time: Friday, April 27, 2018, 6:00 p.m. Pacific Time

Poster: “Measuring withdrawal in a phase 3 study of a new analgesic, NKTR-181, in subjects with moderate-to-severe chronic low-back pain”

o    Presenter: Jack Henningfield, Ph.D., Pinney Associates

o    Session: Poster Session 2

o    Date: Friday, April 27, 2018, 6:00 p.m. Pacific Time
Treg Directed Therapy for Autoimmune Disorders Meeting, Boston, MA: 

Preclinical Data Presentation: “NKTR-358: An IL-2 Pathway Agonist that Selectively Expands and Activates Regulatory T cells for the Treatment of Allergy and Autoimmune Disease”

o    Presenter: Jonathan Zalevsky, Ph.D., Nektar Therapeutics

o    Session: Enhanced Treg-based therapy with the use of IL-2

o    Date and Time: Wednesday, May 23, 2018, 3:40 p.m. Eastern Time
3rd Annual Advances in Immuno-Oncology Congress, London, U.K.:

Presentation: “Accessing The Potential Of An Immunotherapeutic Agent”

o    Presenter: Jonathan Zalevsky, Ph.D., Nektar Therapeutics

o    Session: Translational Immuno-Oncology

o    Date and Time: Thursday, May 24, 2018, 5:40 p.m. London Time
College on Problems of Drug Dependence 80th Annual Scientific Meeting, San Diego, CA:

Oral Presentation: “Neuropharmacodynamic Profile of NKTR-181: Correlation to Low Abuse Potential”

o    Presenter: Laurie VanderVeen, Ph.D., Nektar Therapeutics

o    Session: Preclinical Opioid

o    Date and Time: Tuesday, June 12, 2018, 10:15 a.m. – 10:30 a.m. Pacific Time
Oral Presentation: “Assessment of Drug Abuse-Related Events with MADDERS in SUMMIT-07: A Phase-3 Study of NKTR-181 in Patients With Moderate to Severe Chronic Low-Back Pain”

o    Presenter: Ryan K. Lanier, Ph.D., Analgesic Solutions

o    Session: Pain

o    Date and Time: Wednesday, June 13, 2018, 1:30 p.m. – 1:45 p.m. Pacific Time

NKTR is poised for a strong 2018 with both ‘181 and ‘214 leading the charge forward.  The I/O pipeline is emerging with ‘262 being combined with ‘181 and even triplet therapy when adding Opdivo.  ‘181 has significant potential as non-addictive mu-opioid and the two recent pre-NDA meetings with the FDA, in our view, signal that the agency is anxious to approve ‘181 and showcase it as a much safer alternative to currently abused opioids.  In addition, a major partnership for ‘181 could be struck at any time, now or after it is filed for FDA approval in Q2.  NKTR’s management team continues to deliver on all cylinders.


NKTR is a BUY under 95 with a TARGET PRICE of 120.