NKTR: Q3 transcript and highlights

This transcript is worth a read. CEO updates on the pipeline:

https://seekingalpha.com/article/4122039-nektar-therapeutics…

Pipeline:

[the following is taken directly from the transcript of yesterday’s earnings call so it is the direct quotes from the CEO]:

On today’s call we will review the many upcoming milestones for Nektar’s pipeline over the next 6 months, including our planned submission of an NDA for NKTR-181 and the continued advancement of our IO portfolio, including NKTR-214, NKTR-262 and NKTR-255. We will also update our financial guidance for the remainder of 2017.

NKTR-181

emerged not only as a critically important new potential medicine to treat patients with moderate to severe chronic pain, but also as an important building block in our nation’s effort to solve the opioid public health emergency and stem the tide of new opioid addiction

our data package for NKTR-181 includes an extensive amount of efficacy and safety data in over 2,100 patients and healthy subjects. This includes our 600-patient Phase 3 efficacy trial, our 2 human abuse potential studies, our 630-patient long-term safety and efficacy trial, as well as a wide range of PK and PD studies of therapeutic and super therapeutic doses of NKTR-181 in over 450 healthy volunteers

our Head of Regulatory, Carlo Di Fonzo, recently led discussions with the agency [the FDA] in a Type C meeting in October to discuss our plan to submit an NDA for NKTR-181 for the treatment of moderate to severe chronic low back pain in patients who are new to opioid therapy, also known as opioid-naive patients…as a result of their input we are planning to submit an NDA with the current extensive data package we have for NKTR-181

The staff [the FDA] indicated that a single efficacy trial for approval of a new molecular entity opioid to treat chronic pain will be a review issue and the NDA will also likely go to the advisory committee for discussion and recommendation. In the recent meeting the agency [the FDA] also confirmed that the overall safety database is adequate for an NDA submission.

The agency [the FDA] further confirmed that Nektar has an adequate human abuse potential assessment data package to support an abuse potential assessment review in the NDA, and that both the abuse potential package and the safety database appear to be adequate to warrant a discussion of a less than C2 schedule.

We are on track to submit the NDA in April of 2018.

As the first new full mu-opioid agonist molecule to be developed in over 50 years, NKTR-181’s unique inherent properties position the drug to not only help stem the rate of new addiction to conventional opioids, but also to reduce diversion of prescription pain medications for abuse. The comprehensive NKTR-181 data established the potency of its analgesia, its low abuse potential, its favorable safety and physical dependency profile, and the strength of its molecular structure, which can’t be tampered with, broken or converted into a rapid-acting euphorigenic opioid form. We’re also actively engaged in conversations with potential commercial partners for NKTR-181 so that this important new medicine can be made available to patients

The Immune-Oncology (I-O) Portfolio

including NKTR-214, NKTR-262 and NKTR-255

NKTR-214

very excited about the maturing data from the ongoing trial for NKTR-214 in combination with nivolumab. As a T-cell growth factor, NKTR-214 provides an important and singular new mechanism in immuno-oncology. NKTR-214 acts as a biased agonist on the IL-2 pathway to expand specific cancer-fighting T cells and natural killer cells directly in the tumor microenvironment in cancer patients. It also increases expression of PD-1 on these immune cells

positions NKTR-214 to provide clinical benefit to many patients who currently can’t respond or respond suboptimally to checkpoint inhibitors. Further, NKTR-214 can be administered on an antibody-like dosing schedule, with an exceptionally favorable tolerability profile in combination with a checkpoint inhibitor. There is simply no other IO cancer treatment of its kind in development.

PIVOT NKTR-214/nivolumab abstract contains highly compelling preliminary efficacy data for the first set of 16 melanoma and RCC patients in dose escalation, which had at least one post-baseline scan by the end of July

these early data that show strong response rates in the first set of patients are exciting and earned us an oral presentation at SITC. For Dr. Diab’s oral presentation on Saturday, November 11, he will present efficacy and safety data from the full 38 patients in the entire dose escalation portion of the PIVOT trial, including non-small cell lung cancer patients who are PD-L1 negative and have progressed on prior chemotherapy

We continue to be extremely pleased with how the data are maturing and how NKTR-214 is clearly emerging as a differentiated IO asset that has strong synergy with checkpoint inhibition, particularly in PD-L1-negative patients as an area of high unmet need in today’s treatment paradigm.

Nektar and Bristol are continuing to enroll patients in the expansion cohorts in the Phase 2 stage of the PIVOT trial across multiple tumor indications. Enrollment is proceeding rapidly, with approximately 50 patients already dosed in the expansion. At SITC we will provide more insight on these expansion cohorts and discuss how our data from the dose escalation phase of the study is shaping our planning for the future development of NKTR-214, including potential registrational trials of NKTR-214 with nivolumab or other checkpoint inhibitors. [This is important because NKTR-214 can potentially be combined with MANY other I-O therapies which can potentially lead to many collaborations where NKTR has the possibility to get a piece of many therapies for I-O]

[on the last point:]In addition to the PIVOT trial, we are also conducting the PROPEL trial, which is designed to show that NKTR-214 is also synergistic with other checkpoint inhibitors TECENTRIQ and KEYTRUDA.

Based on its mechanism as a T-cell growth factor we believe that NKTR-214 could be combined with many other agents beyond checkpoint inhibition, as well. For example, at ASCO earlier this year we showed that after NKTR-214 treatment we observed an increase in ICOS-positive CD8 T cells, suggesting NKTR-214 plus an ICOS agonist could be a rational combination.

Another example that we’ve mentioned in the past is the work we have underway with Takeda in liquid and solid tumors with 5 separate Takeda clinical compounds. We expect to have our initial preclinical data from these combinations before the end of this year.

NKTR-262 and NKTR-255, their other I-O druggist development

The portfolio also includes NKTR-262, a TLR agonist, and NKTR-255, an IL-15 candidate which can stimulate both NK cells and memory T cells.

The preclinical data for the 214/262 combination are particularly compelling. We are on track to file the IND for the combination trial of NKTR-262 and NKTR-214 by the end of this year in order to dose our first patients in early 2018. As a novel small molecule TLR agonist, NKTR-262 was designed specifically to be administered with NKTR-214, and, most importantly, would give Nektar our first wholly owned combination regimen in IO.

a quick note on the progress of NKTR-358 with our new partner Lilly. This morning Nektar and Lilly presented very strong proof-of-concept preclinical data for NKTR-358 at the 2017 American College of Rheumatology Annual Meeting in San Diego.

NKTR-358 is advancing through the Phase 1 single ascending dose escalation trial in healthy volunteers

first Phase 1 study evaluates safety, tolerability, and mechanism-based immunological biomarkers associated with the pharmacodynamics of single subcutaneous doses of NKTR-358. Lilly and Nektar are planning to start the Phase 1b trial, which will be multiple ascending dose-escalation studies of NKTR-358, in early 2018. The Phase 1b trial will include evaluation of NKTR-358 in both healthy volunteers and patients with lupus.

[Chris here. Well, there you have the overview and update of NKTR’s pipeline. As you can see, the I-O pipeline is advancing and showing good promise. There are several partnerships. I am particularly excited about NKTR-214 which can potentially be combined with many different drugs/therapies in the I-O space. In addition, NKTR-181 has the potential to be a real blockbuster for pain and there seems to be a lot of support for it because if the nation’s several addition problem with pain medications.]

Chris

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after being up more than 10% yesteday, it looks like NKTR will be up another 10% today…

after being up more than 10% yesteday, it looks like NKTR will be up another 10% today…
Geez!! I cannot help but set up a pilot position.

Alex

Chris, you first brought NKTR to the board back in September. I know it was your smallest position but congratulations on the amazing 140% return in 3 months!

Finally got around to doing some reading myself, then I take a look the the stock price and woah what an increase.

214 seems amazing and I like the potential multiple shots on goal/partnerships it has.
The PIVOT phase 1/2 study (combo with BMS’ opdivo) is due to complete in June 2018 but initial results were out. Obviously a small study but amazingly they’ve got some complete responses (best response possible = no sign of cancer) in a median time of 1.7 months. Wow that’s fast!

Phase 2 - they’re recruiting 350 patients so results in June will be interesting.

NKTR 181 - latest study is a with the primary focus on safety over a year. Taking 638 patients with moderate to severe lower back pain and having them take the drug for 52 weeks. End point for data is this month, but the study won’t complete until March 2018.

Very very exciting drugs, both the 181 and 214. I guess the next catalyst is 181 approval by the FDA and/or NKTR announcing a partnership for 181.

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