January 17, 2019
NKTR made a strong presentation at the recent JPM conference with a detailed focus on the company’s I/O pipeline and the upcoming May 29 PDUFA for NKTR-181.
NKTR-214 is poised to move into move pivotal studies over the course of 2019 including lung cancer, a major market opportunity. The company emphasized that NSCLC as the number one priority for the BMS collaboration on ‘214 and new Phase III trials in both 1L NSCLC and 2L/3L post-CPI NSCLC are set to begin in Q219. The next lung update from PIVOT-02 will come at ESMO (9/27-10/1, Barcelona) as the companies want to deliver more mature data than will be available for ASCO in May. This makes sense as I/O treatments should get better over time and we expect this will be a key focus for the long-term value of ‘214. Data presentations from other PIVOT-02 cohorts will be released throughout 2019, the next of which is the UC cohort at ASCO GU (Feb. 14-16). There will also be additional cohorts presented at tumor specific conferences and larger conferences such as AACR & ASCO.
NKTR-181’s PDUFA is set for May 29th and we expect the FDA to announce an AdCom in 1Q/2Q before the PDUFA. An AdCom makes a lot of sense as the FDA will want as much visibility as possible on ‘181 as it is potentially a significant tool to reduce opiate abuse. Anticipating an FDA approval, NKTR has formed a wholly-owned subsidiary to launch ‘181 and is currently in discussions with capital partners to support that launch. In our view, ‘181 will receive a timely FDA approval which will serve as a significant catalyst for the stock.
In 2019, NKTR/BMS will kick off the next wave of pivotal studies broadening out from the initial melanoma, RCC, and bladder settings into more trials in some of those tumor types but also in NSCLC, SCLC, TNBC, CRC, gastric cancer and sarcoma. In our view, ‘214 holds potential for significant value creation in 2019 as de-risking data continues to read out. NKTR’s broad pipeline is poised to deliver additional data readouts from both immunology and I/O in 2019. Data from NKTR-358 (partnered with LLY) with Phase Ib MAD in lupus underway and first in human data presentation expected at EULAR ’19 (6/12-15, Madrid) and the ‘262+‘214 combo (REVEAL) at ASCO-SITC (2/28-3/2, San Francisco) are first half events that will showcase NKTR’s growing pipeline. In our view, NKTR is poised to deliver significant catalysts in 2019 from both the FDA approval of ‘181 and more positive data from ‘214.