Nektar Therapeutics (NKTR) Q2 2019 Earnings Call Transcript

NKTR earnings call for the period ending June 30, 2019.

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Nektar Therapeutics (NASDAQ:NKTR)
Q2 2019 Earnings Call
Aug 8, 2019, 5:00 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good day, ladies and gentlemen, and welcome to the Nektar Therapeutics Q2 2019 Financial Results Conference Call. Later, we will conduct a question-and-answer session and instructions will be given at that time. [Operator Instructions]

I would now like to introduce your host for today's conference, Ms. Jennifer Ruddock, Head of Investor Relations. Ma'am, you may begin.

Jennifer Ruddock -- Senior Vice President of Investor Relations & Corporate Affairs

Thank you, Crystal. Good afternoon everyone and thank you for joining us today. With us are Howard Robin, our President and CEO; Gil Labrucherie, our Chief Financial Officer; Dr. Stephen Doberstein, our Head of R&D Dr. Jonathan Zalevsky, our Chief Scientific Officer and Dr. Mary Tagliaferri, our Chief Medical Officer.

On today's call, we expect to make forward-looking statements regarding our business, including clinical trial results, timing and plans for future clinical trials, timing and plans for future clinical data presentations at medical meetings, the therapeutic potential of our drug candidates, the effects of manufacturing processes and controls, outcomes and plans for health authority regulatory actions and decisions, financial guidance and certain other statements regarding the future of our business.

Because these forward-looking statements relate to the future, they are subject to inherent uncertainties and risks that are difficult to predict and many of which are outside of our control. Important risks and uncertainties are set forth in the Form 8-K filed today and the Form 10-Q that we filed on May 9, 2019, which is available at www.sec.gov. We undertake no obligation to update any of these forward-looking statements whether as a result of new information, future developments or otherwise.

A webcast of this call will be available on the IR page of Nektar's website at nektar.com. With that, I will turn the call over to Howard, Howard?

Howard W. Robin -- President and Chief Executive Officer

Good afternoon everyone and thank you for joining us on today's call. Today we'll review the quarterly results, provide several updates on our programs in the clinical pipeline, including a specific discussion on the Nektar 214 or the bempeg program and reiterate our financial guidance for 2019.

I'll start with several updates on our pipeline programs. First, NKTR-181, as we previously announced in late July. The FDA issued a General Advice Letter, which was sent to several sponsors including us. The letter stated that the FDA would be postponing product specific opioid analgesic advisory committee meetings, while they consider certain scientific and policy issues for the opioid class of pain treatments.

This includes the Advisory Committee meeting originally scheduled to review NKTR-181 on August 21st. We will work with the FDA as they continue to review of our NDA. We are hopeful based upon our interactions with the agency that the FDA will be able to reschedule the panel before the end of the year. They have told us that they would inform us as soon as they could, on the timeline for the new meeting and of course we're disappointed in the delay, but we understand the importance of the agency taking a comprehensive view as they address considerations for this class of drugs.

The FDA has been very cooperative in the development and review of NKTR-181 and we believe that NKTR-181 will be a step forward in an important building block to help address the opioid epidemic. Our NDA includes a 2,200 patients and healthy volunteer data package to support its profile. We invented this product with a specific objective of helping to address the opioid crisis that plagues our country. We look forward to a scientific discussion at the rescheduled Advisory Committee meeting and continued collaboration with the FDA team.

This past quarter we created a wholly owned subsidiary, Inheris which is preparing to launch NKTR-181 upon its potential approval. As we head to a potential approval. Our objective is to finalize the capital structure with one or more potential capital partners in order to support these activities. The goal is to introduce a different model in the pain space using a specialized medical liaison team and a small sales force. We are carefully gating our spending at each stage prior to potential FDA approval and commercial launch of NKTR-181.

We continue to be very excited about the future for this novel potential medicines. Next I'd like to provide a brief update on NKTR-358, our T regulatory IL-2 pathway candidate, which is advancing in the clinic for treatment of autoimmune conditions. We presented our first in-human single ascending dose study data that is passed June [Phonetic] Congress, which demonstrated the NKTR-358 selectively stimulates T regulatory cells in a dose-dependent fashion.

We plan to present additional data from this first trial at the American College of Rheumatology meeting later this year. The multiple ascending dose study in lupus patients is continuing and based on its completion later this year. Lilly has plans to initiate a Phase IIb [Phonetic] dose ranging lupus study early next year.

Lilly, is also planning to start new Phase Ib studies later this year. In two other auto-immune and inflammatory diseases. Lilly in Nektar very excited about NKTR-358 and its potential to become the first resolution therapeutic for multiple auto-immune and inflammatory indications. Moving on to NKTR-255, our IL-15 an agonist program, we are pleased to report that the IND for NKTR-255 were successfully filed with the FDA and we're initiating our first in inhuman clinical trials this quarter, in patients with either relapsed refractory non-Hodgkin's lymphoma or multiple myeloma.

The first study are designed to evaluate the safety and dose schedule of NKTR-255 as a monotherapy evaluate biomarkers into expand into combination with an antibody that works through an ADCC mechanism. As IL-15 strongly promotes the expansion, activation and survival of NK cells. We are excited about its potential to successfully combined with the ADCC mechanism. We recently entered into an agreement with Janssen and which they will study NKTR-255 in preclinical models, combined with therapies in their oncology portfolio, and we will contribute NKTR-255 and Janssen will be responsible for the cost of the studies.

In addition, we're also planning to initiate a clinical trial for NKTR-255 in combination with CD19 CAR-T cells in patients with diffuse large B-cell lymphoma. The study is based upon the compelling preclinical data that was generated by our collaborators at the Fred Hutchinson Cancer Center, which demonstrated that NKTR-255 could enhance the persistence of CAR-T cells, leading to more durable responses following CAR-T therapy in animal models.

We're planning a number of presentations for NKTR-255 at the upcoming ASH Conference later this year, including additional data with CAR-T therapy. Finally, our research collaboration with Gilead for NKK-255 is continuing nicely, they are evaluating NKTR-255 with various molecules and their portfolio in the area of virology, which is an entirely different application for this important mechanism.

So, we're very pleased with the advancement of our IL-15 program. Now, I'd like to discuss the bempeg program. As you know, last quarter, we extended the start time for registrational trials under the BMS collaboration by four months. In order for BMS to maintain exclusivity for the indications, indicated, included in those registrational trials.

We currently have four registrational trials ongoing. One in first-line melanoma, one in first-line cis and that was real urothelial cancer, one in first-line renal cell carcinoma and one in second-line relapsed non-small cell lung cancer.

Over the past several months, we and BMS have been working together on our development program of registrational trials of bempeg and nivo and various tumor types and indications in a highly complex and changing competitive landscape for the anti-PD-L1 class.

As both companies have stated BMS and Nektar have been encouraged by data in a number of tumor types from PIVOT-02, our Phase 1,2 study of the doublet of bempeg and nivo. At the recent ASCO 2019 Meeting, we reported an update from the first-line melanoma cohort in PIVOT-O2 that showed an improvement in complete response rates and deepening of responses for patients who responded to the doublet therapy a clear benefit for these patients.

We recently announced that these compelling data led to a breakthrough designation from the FDA. Notwithstanding this extremely positive development, we like you still have lingering questions about the softening in response rates that we observed in PIVOT.

In particular, if you remember back when we presented data at ASCO in 2018, many of you asked us about the softening in response rates, which in the first and second Fleming cohorts in melanoma and what could be the underlying cause of this variance. As more patient data have matured and become available over the past six-months, we've continued to analyze all of the PIVOT cohorts closely and an effort to understand whether there was a root cause to this observation or whether it was a result of normal variability.

Now, let me tell you what we've learned. As we've been working to finalize the manufacturing process and increased production capacity, in order to supply a large scale clinical program and validate commercial scale manufacturing, we established all of the compendium methods that are expected in accordance with normal GMP guidance.

In addition, we created new product specific assays to views for quality control in this scaled manufacturing process. With these new assays, we conducted a thorough characterization of all of the 22 lots of bempeg produced to date including all of those, which currently supply and will supply our current and future registrational studies, the characterization work from these new assays revealed that two of the earliest production batches of bempeg were different than the other 20 batches produced. These two early manufacturing lots are known as lots 2 and 5, and at the time of their production bidding -- beginning in 2016, it was early on, in the manufacturing campaign and these lots were within the manufacturing controls and release specifications.

As such, we did not detect any meaningful variability upon their release. Various early production batches of bempeg were sequentially distributed in PIVOT-02 lots 1, 2, 3 and 5. As more clinical data matured and became available in PIVOT-02 and once we have identified the outlier variances of lots 2 and 5. We then had the basis to start analyzing any potential differences between data from patients that started treatment with lots of 1 and 3 as compared to lots 2 and 5. We found notable correlations in several cohorts with evidence of an improved clinical benefit in patients who started treatment with lots 1 and 3 as compared to patients who started treatment with lots 2 and 5.

We have identified the cause of the physical differences between these lots, which we now know stemmed from a single sub-optimal batch of in-process intermediate that was used to produce only these 2 lots, lots 2 and 5 of the 22 lots we've made to-date. The issue was restricted only to the single batch of intermediate used in lots 2 and 5 and importantly our recently developed product assay show that fortunately the rest of the bempeg batches that have been produced have characterization profiles comparable to lots of 1 and 3. Lot 2 had already been fully used in PIVOT and lot 5 was almost fully utilized in PIVOT and propel. No material from lot 2 or 5 is currently being used in any of the ongoing clinical trials and this material has not been used at all in any of the ongoing registrational trials.

As a result of this discovery, we have developed a comprehensive control strategy to limit variances in raw materials, intermediates and the final product in our manufacturing and this is being validated for commercial-scale manufacturing. This has been submitted to an accepted by FDA in collaboration with BMS. The new assays and control strategy is also allow us to build new IP around the product.

In addition, as we were scaling up manufacturing, we also changed the structure of our CMC organization in terms of leadership and alignment of skills in activities. Supply chain and manufacturing are now being run with new leadership under Kevin Brodbeck who has successfully led our manufacturing activities for other programs with partners from development through commercialization and Biologics Process Sciences is now reporting to our Chief Scientific Officer, Dr. Jonathan Zalevsky as his team has deep subject matter in this area.

I'll now turn the call to Steve Doberstein to comment on some additional detail with respect to the clinical differences based on the drug lots we observed in PIVOT. As notable as these correlations are to us and BMS , they of course cannot be used to determine causality [Phonetic]. These clinical differences between lots were also shared with the FDA as part of the review of our control strategy. Steve?

Stephen K. Doberstein -- Chief Research & Development Officer

Thank you, Howard. First, I'd like to outline how we analyze differences in the clinical performance between the lots. The majority of patients in PIVOT-02 rotated through different lots beyond cycle 3 of their treatment. So we focused our analysis on clinical differences based on the starting lots, that a patient received. As of mid-May. Approximately half of the patients in PIVOT began treatment with lots 1 and 3 and half began treatment with lots 2 and 5.

We looked at differences in safety, first scan response and best objective response rate including complete response rate. In a particular cohorts of first-line melanoma, first line renal cell carcinoma and first line urothelial carcinoma. We saw a correlation between improved clinical benefit and those patients who received lots 1 or 3 for their first dose as compared to those who received lots 2 or 5 for their first dose.

This trend of improved clinical benefit was maintained even when analyzing these metrics by patient demographics, baseline disease criteria or investigator sites. Given that the usage of the sub-optimal in-process intermediate was limited to only lots 2 and 5, we combined the data for patients initially dosed with either lots 2 or 5 together and we combined the data for patients who started within trend lots 1 or 3 together. First, let's start with safety. We observed no meaningful differences in safety between lots 1 and 3 and lots 2 and 5. Although some minor differences were observed in a directional trend toward more reported AEs did occur with lots 1 and 3.

Overall the safety profile of the doublet continues to be well tolerated and is consistent with our prior data presentations. Starting now with the first-line melanoma cohort. As you'll recall, the best objective response rate as reported to ASCO 2019 for efficacy of valuable patients was 53% with a complete response rate of 34%.

In addition, 42% of patients who achieved 100% reduction in their target lesions. All 10 patients who are on treatment at the time of ASCO 2019 remain on treatment today or have achieved maximal clinical benefit in the study.

As Howard stated these data recently led to a breakthrough designation in first-line melanoma. Notably, when you analyze this cohorts by combined lots for the 16 patients who started on lots 1 and 3, the response rate at first scan was 56%. The response rate at 1st scan for the 22 patients who started on lots 2 and 5 was only 18%.

The best objective response rate for lots 1 and 3 was 75% with a complete response rate of 44%, for lots 2 and 5 the best objective response rate was 36% with a complete response rate of only 27%. As you'd imagine these response differences also lead to an improvement in PFS seen between the lots. You'll recall that the overall patient population was at a median 12.7 month follow-up, at ASCO 2019 and the median PFS was at a minimum of 12.7 months.

When you break out those patients who started on lot 1 and 3, median PFS can't yet be estimated because there are too few events of progressive disease. However, for patients who started on lots 2 and 5 median PFS is estimated at 5.2 months and is reflected in the minimum median PFS of 12.7 months for the overall cohort.

Notably 41% of the 22 patients who started on lots 2 and 5 experienced progressive disease at first scan. In the first-line urothelial cancer cohort. We now have 37 patients valuable for efficacy by investigator and we plan to present these data for this cohort at a future medical meeting, since we first presented our urothelial cancer data at ASCO GU unfortunately 80% of new patient enrollments started treatments on lots 2 and 5.

Currently the best ORR for the entire cohort is 38% with a complete response rate of 14%. There are still 13 patients with treatment ongoing in this cohort of these five have experienced complete responses and an additional five more patients could see further deepening of response. There are also four patients were being treated beyond progression. When you analyze these data by lots, for the 12 patients who started on lots 1 and 3 response at first scan was 42%.

The response at first scan of the 25 patients who started on lots 2 and 5 was 32%. For patients who started on lots 1 and 3, the best objective response rate was 50% with a complete response rate of 42%. For patients who started on lot 2 and 5 the best objective response rate was only 32% and none of these patients had a complete response. These response differences also led to an improvement in PFS for patients who started on lots 1 and 3. PFS for the urothelial cohort is quite immature. It can be estimated at 4.1 months for the entire cohort, but when you examined by starting lot, for patients who started on lots 1 and 3, median PFS can be estimated at 5.5 months and for patients who started on lots 2 and 5 median PFS is estimated at only 3.5 months.

In the first line renal cell carcinoma cohort. We currently have 49 patients valuable for efficacy by investigator. Currently the best ORR for the whole cohort is 35% with a complete response rate of 4%, 11 patients remain on treatment in the RCC cohort.

When you examine clinical performance by lot for the 25 patients who started on lots 1 and 3, the response at first scan was 20%. For the 24 patients who started on lots 2 in 5, the response first scan was only 4%. The best objective response rate was 40% for patients starting on lots 1 and 3 as compared to a best objective response rate of 29% for lots 2 and 5.

Median PFS is quite immature for the whole cohort, but is estimated at 7.6 months. When you analyze by lots for this cohort median PFS for patients who started on lot 1 and 3 was only -- was 11.2 months and median PFS for patients who started on lot 2 and 5 was only 5.5 months.

In first-line non-small cell lung cancer. When we examine the first scan depth of tumor reduction split by lots. There is some early evidence that the 16 patients who started on lots 1 and 3 are experiencing a greater reduction in their target lesions than the 13 patients who started on lots 2 and 5. However, the data are very immature in this cohort and will continue to monitor whether this trend continues as data mature and as more patients are enrolled.

In other cohorts in PIVOT beyond the ones I've just described. We did observe some clinical differences between patients who started on different lots. However, the differences were not as notable as they were in the other first-line settings.

As of the May 17, data cut, we did not meet the Fleming thresholds for the response rates for relapsed or refractory settings in PIVOT-02 and this has made it more difficult to discern any differences in these cohorts. However, there are similarities, for example in the cohorts of second and third line non-small cell lung cancer, the few responses we observed were in patients who started on lots 1 and 3. In the second line I-O naive RCC cohort over half the patients who started on lots 2 and 5 had progressive disease at first scan as compared to only 16% who started on lots 1 and 3.

Before I hand the call back to Howard, I'd like to briefly comment on plan data presentations for the rest of the year. First, in melanoma. Despite the differences between patients who started treatment with lot 2 and 5 in PIVOT-02. We're pleased with the ongoing deepening of responses we've reported in the first-line melanoma cohort, we and BMS have submitted an abstract to present updated 18-month follow-up data at the 2019 SITC meeting.

Second in triple-negative breast cancer. We have submitted an abstract to the upcoming CRI quadruple meeting for this cohort, we intend to hold a webcast with a leading breast cancer expert to review these data during that meeting.

Third, RCC. We are planning to submit these data from this cohort for possible presentation at ESMO IO in December. Fourth, non-small cell lung cancer. In January, of this year at the time of the JP Morgan Conference. We had 10 patients valuable for efficacy with varying PD L1 status across all three of our first-line non-small cell lung cancer PD L1 expression sub-cohorts enrollment has been slower than we anticipated in these cohorts. And there are a number of patients who were enrolled more recently in the second and third quarters.

Overall, the early data we are observing in these few patients in the first-line non-small cell lung cancer sub cohorts support the bempeg mechanism of action and its potential benefit in the below 50% PD L1 expressers and in the PD L1 negative baseline patients, as you know we've reported that effect in other tumor types as well.

In the greater than 50% PD L1 expression sub-cohort we haven't seen the same benefit, and we're trying to understand this observation in light of the manufacturing issue. As I just stated, when we examine the depth of tumor reduction by lots. There is some early evidence that patients may be benefiting more when started on lots 1 and 3.

We're enrolling additional patients in the first-line non-small cell lung cancer cohorts, and those patients are starting treatment with bempeg lots that are not lots 2 and 5. As a result of the current immaturity of the data and the desire to continue to enroll more first-line non-small cell lung cancer patients we withdrew our accepted abstract for the upcoming ESMO meeting, we plan to present these first-line non-small cell lung cancer cohorts once the data are more mature.

As you'll recall, our PROPEL study was designed to be a dose finding Phase 1 trial to evaluate pembrolizumab in combination with bempeg in non-small cell lung cancer and other tumor types. As Howard stated earlier lot 5 was almost fully utilized in PROPEL. Now that patients are starting on different bempeg loss and PROPEL, we plan to focus on enrolling first-line non-small cell lung patients into PROPEL, and we're also evaluating different dose levels of bempeg in non-small cell lung cancer to ensure dose optimization. This will allow us to generate important data in first-line non-small cell lung cancer with the pembro and bempeg doublet.

With respect to additional trials starting with other collaborators and bempeg, Pfizer and Nektar have finalized the Phase 1b/2 study and had a neck cancer and castration-resistant prostate cancer. The study will be initiating imminently and we'll evaluate various doublet and triplet combination with bempeg and Pfizer and Merck Serono's anti-PD-L1 patient avelumab, Pfizer's PARP inhibitor talazoparib and Pfizer and Astellas' enzalutamide. We're very excited to work with Pfizer on this because of the opportunity in these two solid tumor settings for bempeg particularly in patients that with PD L1 negative tumors.

With that, I'll turn the call back over to Howard. Thank you.

Howard W. Robin -- President and Chief Executive Officer

Thank you. Of course, we are very disappointed that the discovery of this historical problem [Technical Issues]

Operator -- President and Chief Executive Officer

Ladies and gentlemen, please standby.

Howard W. Robin -- President and Chief Executive Officer

Sorry.

Operator -- President and Chief Executive Officer

Pardon me. You may proceed.

Howard W. Robin -- President and Chief Executive Officer

Sorry, we got cut off for a moment. Thanks, Steve. Of course, look, we're disappointed to have discovered this historical problem with these early manufacturing lots, but we believe we've identified and develop solutions to these issues and we now believe we have the right drug product to support the registrational trials. We and BMS are working together to ensure consistent and comprehensive quality control has implemented for commercial-scale manufacturing for bempeg.

Nektar and BMS have also been in regular dialog over the past few weeks regarding the development program. BMS has communicated to us that they remain very committed to the bempeg development program, particularly in light of the recent breakthrough designation in melanoma and the tremendous opportunity for both companies.

They are highly committed to the ongoing registrational trials in first-line melanoma, first line urothelial cancer and first line renal cell carcinoma, as well as our new expansion cohort of second-line non-small cell lung cancer patients in PIVOT.

Additional trials with BMS are under discussion and being planned where it makes sense based upon support PIVOT data or existing standard of care in a tumor setting, we and BMS plan to focus on 5 or 6 key registrational trials that will clearly demonstrate the clinical benefit of bempeg and nivo.

Certain other trials in indications, we may do in partnership with other collaborators. As part of this, we will be carefully evaluating the timing and allocation of our resources as we finalize details of the overall bempeg program. We are in a very fortunate position with a strong balance sheet. However, we're going to be prudent in our capital allocation plans and the objective of getting bempeg approved as quickly as possible and advancing our pipeline with the resources on hand.

And with that, I'll hand the call over to Gil to review our financial guidance for 2019.

Gil M. Labrucherie -- Senior Vice President and Chief Financial Officer

Thank you, Howard, and good afternoon everyone. Today we issued our financial results press release for the quarter ended June 30, 2019. I will briefly review our updated 2019 financial guidance. Starting with our cash position, we anticipate in 2019 with at least $1.5 billion of cash and investments.

Our full-year GAAP revenue guidance remains between $100 million to $110 million. For GAAP expense guidance, we now anticipate 2019 GAAP R&D expense will range between $475 million and $500 million , which includes approximately $80 million of non-cash depreciation and stock compensation expense.

G&A expense for 2019 is still projected to be between $110 million and $120 million which includes approximately $35 million of non-cash depreciation and stock compensation expense. We continue to invest in activities necessary to support regulatory approval of NKTR-181 and as Howard discussed earlier we are carefully staging our investment and commercial readiness for NKTR-181 as we approach a potential approval later this year.

And with that I will open the call for questions. Operator?


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Questions and Answers:

Operator

Thank you. [Operator Instructions] And our first question comes from Chris Shibutani from Cowen. Your line is open.

Chris Shibutani -- Cowen & Co. -- Analyst

Great, thank you very much. A lot of information packed in there. Fair amount to digest. Just trying to figure out what the right sequence of questions and I'm sure many of my colleagues will follow as well, but to make clear, you said that your analysis was that it was the initial dose from the lots that were problematic that were associated with the differences in response rates and clinical response that you were measuring. Mechanistically, can you explain why that would be the case.

My second question relates to the Bristol collaboration. You had previously disclosed that the timeline had been extended to the end of September to make commitments. Is that still the case, and now firm that whatever programs get extended or commenced by the end of September that will be the time point at which you would then proceed to making decisions potentially with other collaborators. Thanks very much.

Stephen K. Doberstein -- Chief Research & Development Officer

Yeah. Thanks, Chris. This is Steve. With respect to at the analysis that we did one of the things that confluence [Phonetic] analysis, it makes it very difficult. Is that, as we indicated patients go after the first couple of doses, patients tend to rotate on and off different batches, we don't -- it's not like one patient gets the same batch all the way through their treatment. And so what that means is that it's actually quite a bit more difficult to see the kinds of correlations that we've seen here.

So, I think rather than being a mechanistic explanation, although there may be an underlying biological mechanism for it. I think it's more likely that we see the correlations simply because that the numbers of patients that are pure patients that have only seen one particular batch throughout their treatment course diminishes over time quite rapidly. And by the time you get to about the third dose almost everybody has gotten multiple batches at that period -- at that point in time.

Howard W. Robin -- President and Chief Executive Officer

This is Howard, let me answer your question about -- on BMS. Look clearly as you develop the program that has this type of magnitude, you have to look very carefully at the landscape. And the landscape for PD-1 agents has clearly evolved and changed and we're looking at that carefully with BMS seeing where it makes most sense to develop nivo and bempeg. And in addition, clearly, we had to delay here because of these manufacturing lots that we recently correlated with clinical data and to that end, I'm not going to be very specific on whether it's a September date or in October date or this month date. I think that probably isn't terribly relevant right now, what I said was that together, we have three trials, three registrational trials, very large trials already running, we are planning on doing a number of additional trials and to the extent that we evaluate the landscape and determine that it isn't worth pursuing a specific indication then Nektar will be free to pursue that with other agents.

And whether, whether that's a definitive cut off by the end of September, that's probably not terribly relevant, I can tell you that those types of decisions will be made in the very, very near future. And we'll be announcing our plan to move forward.

Chris Shibutani -- Cowen & Co. -- Analyst

And then, sorry, can I just ask, is there a way, the difference in the batches 2 and 5 to translate that over to some of the characteristic of the final drug product. Would you say that the shortcomings in batches 2 and 5 were related to decreased potency. Is there some change in the deep regulation rate that would have made some0 question bio-availability [Indecipherable]. Can you link the two together at all?

Jonathan Zalevsky -- Chief Scientific Officer

Hey, Chris. Can you hear me. This is Jonathan Zalevsky.

Chris Shibutani -- Cowen & Co. -- Analyst

Yeah. Hey, Jon.

Jonathan Zalevsky -- Chief Scientific Officer

Yeah, hey, there. Yeah. So what we have done is we have looked at the kind of physical differences between the different batches and as you remember, we published a model that described how receptor bias and receptor occupancy arises from bempeg the drug. This was in our plus publication a few years ago. So, we were able to use that model and we did identify that the characteristics of these batches 2 and 5 would make them less effective at occupying the receptor the same way as we reported in that paper and so they would arise less buyers. That's one of the things that we've learned.

Chris Shibutani -- Cowen & Co. -- Analyst

Okay, thanks. I'll get back in the queue, I am sure plenty of other related questions. Thank you.

Operator

Thank you. Our next question comes from Jessica Fye from JPMorgan. Your line is open.

Jessica Fye -- JP Morgan Chase & Co. -- Analyst

Great. Good afternoon and thanks for taking my questions. From a development plan standpoint, you mentioned that you and Bristol plan to focus on 5 or 6 key registrational trials and you outlined for the beginning of the call between first-line melanoma first line since notably you see second-line non-small cell in first line renal. Can you help us think about what other settings , those one to 2 other registrational trials might be in

Howard W. Robin -- President and Chief Executive Officer

Sure. Jessica, I think, look, obviously we're evaluating how we want to proceed forward in first-line non-small cell lung cancer. And like I said, we are -- we're already running those trials in the PROPEL study with pembro, but we are certainly evaluating whether BMS and Nektar want to move forward in that area. And I know they have a high level of interest in that and there might be one or two other trials. We look at in bladder cancer in melanoma. I think there's a number of possibilities, let's just say this, if we get, if we, and I believe we will have six major registrational trials running in six different indications with BMS. I do believe that's a good way to develop and focus development of net of bempeg and I would expect that that's where we wind up clearly at this point, running 20 trials is probably not the right thing to do in terms of, in terms of how we use our resources. But I think if we, if we identify and I know we will 5 or 6 very relevant very significant registrational trials. I would expect that we can bring bempeg and nivo to a very, very good result and that's our plan to go forward.

Jessica Fye -- JP Morgan Chase & Co. -- Analyst

Okay, got it. And Howard, just kind of following up on that, in your quote, in the press release, I think you mentioned the potential for the doublet of bempeg and nivo. I just wanted to confirm is that to say that there maybe be less interest now in exploring that I-O doublet in combination with chemo TKI's et cetera.

Howard W. Robin -- President and Chief Executive Officer

I'm going to let Mary cover where we're going with that. Hold on. Thank you.

Mary Tagliaferri -- Chief Medical Officer

Yeah. Hi Jess, it's Mary. We are continuing to evaluate our options with the doublet and other agents both chemotherapy and TKI and so we'll keep you posted on the additional development and results in those studies. Thanks.

Jessica Fye -- JP Morgan Chase & Co. -- Analyst

Okay, great. And maybe just a last one, just to make sure I understand with the potentially registrational non-small cell expansion cohort in those patients who progressed on PD-1 plus chemo. Do you anticipate updating that data or presenting that data along the way or should we only expect to hear the results from that study once it's mature. I think it's been estimated its being kind of like a second half 2020 event?

Mary Tagliaferri -- Chief Medical Officer

Yeah, thanks for the question, Jess. Yes, we are anticipating in the second half of 2020. We also believe we should have data from the first line since ineligible bladder cancer study in the second half of 2020 as well as some early data from the Phase III in melanoma that same time frame?

Howard W. Robin -- President and Chief Executive Officer

And Jessica, I think as we, as we move forward in the PROPEL study studying non-small cell lung cancer in combination with pembro we'll be reporting on that as well.

Jessica Fye -- JP Morgan Chase & Co. -- Analyst

Great. Thank you.

Operator

Thank you. Our next question comes from Tyler Van Buren from Piper Jaffray. Your line is open.

Tyler Van Buren -- Piper Jaffray -- Analyst

Hey guys, good afternoon. Thanks for taking the questions. The first one is a point of clarification for the breakthrough therapy status in melanoma. Can you confirm if that was based on the 53 or 34 [Phonetic] unless that order was presented at ASCO or if they were aware of what was going on here with the manufacturing and if it was based on that 75. The higher 75 response rate?

Stephen K. Doberstein -- Chief Research & Development Officer

Yeah. Tyler, this is Steve. The breakthrough status is based on the entire dataset that was presented as it was presented at ASCO 2019. So while the agency is aware of the difference in the response rates between the batches that we talked about that the breakthrough status is based on the entire data set altogether.

Tyler Martin Van Buren -- Piper Jaffray Companies -- Analyst

Okay, that's helpful.

Howard W. Robin -- President and Chief Executive Officer

And then, and just -- and just to add to that, that was after -- that breakthrough designation came after the entire control strategy and data was presented to the FDA regarding these cohort differences.

Tyler Martin Van Buren -- Piper Jaffray Companies -- Analyst

OK, that's helpful. And when you are talking about first-line long in the breakdown of PD-L1 greater than 50 below 50 and negative and the differences there. You said, I think it's less than 50 PD-L1 expression status and negative that the data supports the mechanism of action of bempeg plus nivo. So can you just expand upon what you observed there in those cohorts that supports the MOA [Phonetic]

Stephen K. Doberstein -- Chief Research & Development Officer

Yeah, what I mean by that, Tyler, is that, when we look at -- while the data are immature as we indicated during the talk. But when we look at first scan reductions in tumor size in those, in those patients, in those cohorts. We see, I think what I would characterize is promising results that do support that there is added efficacy between bempeg plus nivo overall we would expect from checkpoint alone.

Tyler Martin Van Buren -- Piper Jaffray Companies -- Analyst

Got it. Okay and then just to follow-up on the pivotal trials before that are ongoing. Can you confirm the order in the second half of next year is based upon current enrollment of bladder, melanoma and [Indecipherable] if I recall that might have been the order last time we spoke, and then also in melanoma. I think you guys said it was an early data look, is that still not going to be the median progression-free survival endpoint for potential approval and as a follow-up, do you still have that interim overall response rate look at six-months prior to that as well.

Stephen K. Doberstein -- Chief Research & Development Officer

Yeah. So look, it's a little bit too early. I think to handicap the specific order of finish of those trials. They're all still enrolling obviously, the big one is melanoma and that I think is the one that is being operationalized by by BMS. I'll let Mary speak to the specifics of how that data are going to roll-out with respect to ORR analysis and things like that.

Mary Tagliaferri -- Chief Medical Officer

Yeah, hi, Tyler, this is Mary. Yes. We expect the first data to readouts for the Phase III melanoma trial in the second half of 2020.

Tyler Martin Van Buren -- Piper Jaffray Companies -- Analyst

Okay. Thanks for taking the questions.

Operator

Thank you. Our next question comes from Paul Choi from Goldman Sachs. Your line is open.

Paul Choi -- Goldman Sachs Group Inc. -- Analyst

Hi, thank you everyone. Good afternoon and thanks for taking our questions. If you could maybe just go focus on the, your comments with regards to the long study. And you highlighted that you are seeing differences and the -- are some benefit in the PD-L1 negatives on the PD-L1 low patients versus the PD-L1 high expressers. Is there any plan maybe to accelerate the enrollment in those, those patient subgroups and could that represent potentially your fastest avenue of developments in lung here or in terms of advancing dataset out to the public domain and when could that possibly happen if the enrollment there is is happening a little faster.

Stephen K. Doberstein -- Chief Research & Development Officer

Look, the biggest need in that indication of course is in those patients who are PD-L1 negative at baseline and in those patients that are PD-L1 to 49%. So that's exactly the area in which we think we get most benefit. And as we are doing throughout the rest of the program, that's where we're focusing our most accelerated efforts I think we'll continue to divide those in those subgroups as we study one both with nivo and with pembro in the context of the PROPEL study.

Paul Choi -- Goldman Sachs Group Inc. -- Analyst

Okay. And then, just on the PROPEL study. Can you maybe, just confirm for us. I think you said lot 5 was not used, but in terms of the go forward here have any other patient has been exposed to some of the questionable lots? And I guess, can you just confirm for us, I guess with the plan patient enrollments if there are any on any currently enrolled, patients who were exposed to some of the earlier lots?

Stephen K. Doberstein -- Chief Research & Development Officer

So, let me take the first part of that question first. What we meant to communicate is that in PROPEL all of the initial patients has received only lot 5. So that confounds the early set of patients that were in that trial, quite a bit. Now, there are still patients on all of our studies who received some level of lot 2 and 5.

Paul Choi -- Goldman Sachs Group Inc. -- Analyst

Okay. Thank you for that.

Operator

Thank you. Our next question comes from Difei Yang from Mizuho. Your line is open.

Alex Lim -- Mizuho Securities -- Analyst

Hey, good afternoon guys. This is Alex on for Difei. Just a clarification question for me. In your four ongoing registrational trials. Can you just confirm that you mentioned earlier no patients were treated with the affect of batches. Is that correct?

Howard W. Robin -- President and Chief Executive Officer

That is correct. We -- as Steve said earlier lot 2 was few fully utilized and lot 5 was partially utilized. And so none of the patients in any of the registrational trials have ever received lot 2 or 5 and in terms of the PROPEL study. Just to further clarify and what Steve was mentioning before as the PROPEL study moves forward, it will obviously not have lot 2 or 5 involved with it.

Alex Lim -- Mizuho Securities -- Analyst

Okay. Thank you.

Operator

Thank you. Our next question comes from Bert Hazlett from BTIG. Your line is open.

Robert C. Hazlett -- BTIG -- Analyst

Thank you. Like to kind of take a step back and ask maybe more generally about the relationship with BMS and it maybe I'm hearing this incorrectly, but I'd love for you to verify it is the agreement under consideration for renegotiation or there clawbacks or there are potential material reconsideration clearly the prioritization appears to be different but somewhat, but I'd love for you to characterize the specifics with BMS at this point, if you can?

Howard W. Robin -- President and Chief Executive Officer

Sure. Well, first of all, there are no clawbacks, there is no renegotiation. The fact is that at this point, we will be moving forward with 5 or 6 major registrational trials, albeit we're not moving forward with 18. I think everybody understands that by now, but there are no clawbacks. There is no effect there on terms or conditions and to the extent that BMS chooses not to move forward in a particular indication, then we are free to work with other companies in that indication and that will be, we will be dealing with that and ascertaining that very, very shortly, and I realize I said earlier, whether I can't promise that that's going to be September, it's going to be October. But in the very, very near future, we will have an absolute plan that we bring forward with BMS. So that everybody understands exactly where we're working on.

We've already defined four of those programs, the most likely be two more and we will communicate that with everybody. But there are no clawbacks there is no provision for changing anything. The contract is working as it should. And to the extent that BMS does not want to move forward in any specific areas than those are ours to do what we want with.

Robert C. Hazlett -- BTIG -- Analyst

Okay, thank you very much for that. And then with regard to your PROPEL. Can you just maybe a little bit more clarity, is there is there a kind of a restart being contemplated in a certain way, how do you -- how are you thinking about that data with lot 5 in PROPEL and what can you do with that data and really how are you moving forward with that study?

Howard W. Robin -- President and Chief Executive Officer

Yeah, I wouldn't, I wouldn't call it a restart of Propel, I think we unfortunately lot 5 was used in all the PROPEL patients and we are now using other lots which are comparable to lots 1 and 3 and we will be moving forward and PROPEL particularly in first-line non-small cell lung cancer in combination with pembro and as data emerges from that study, we will share with everybody so we are refocusing it but I wouldn't say we're restarting it.

Robert C. Hazlett -- BTIG -- Analyst

Okay. And I just ancillary question. I know the molecules are related, but 2, 1, 4, 3, 5, 8 is there any reason to think that potential similar circumstances have going on with the manufacturer of 358 or have you looked into that at all.

Jonathan Zalevsky -- Chief Scientific Officer

Hey Bert. This is Jay-Z, no this manufacturing issue was solely and exclusively related to bempeg it does not impact any of the other molecules that we manufacture either ourselves or any of our partner of collaboration.

Robert C. Hazlett -- BTIG -- Analyst

Okay, thank you.

Operator

Thank you. Our next question comes from Andy Hsieh from William Blair. Your line is open.

Andy T. Hsieh -- William Blair & Company -- Analyst

Great, thanks for taking my question. I'm trying to piece together the exact mechanism. It seems like patients who will receive treatment from lots 2 and 5, the response rate and durability atleast that you look like they just received Opdivo alone. So in terms of -- Jay-Z, I think you mentioned about the differences in receptor, occupancy is it, is it a problem with the primary sequence, is it primary -- is it problem with the peculation. And in terms of that did you guys get a chance to look at bio-marker, data, to kind of correlate to be -- to lost 2 and 5 issues and really see a difference, not only in the occupancy, but also biomarkers specifically priming of the T-cells and everything, you guys have been looking at.

Jonathan Zalevsky -- Chief Scientific Officer

Yeah, hey, Andy, this is JZ. So yes, we did look at a number of these. And let me kind of summarize some of those. So let's start off with the pharmacodynamic. So we did look at the pharmacodynamics between the different lots and between the different patients of course in PIVOT and I will say that we did not observe specific pharmacodynamic differences between the lots. But we do have to remember, there are some limitations and the main one being that we only collect and on treatment biopsy at week three. So basically, at the end of that first cycle, so we don't know if other time points would have shown us other kinds of differences.

And while we didn't see some of those pharmacodynamic differences as I mentioned, are mathematical modeling did indicate that based on some of these physical differences, we would expect a really different profile of receptor occupancy, particularly the bias around the [Indecipherable] beta gamma receptors. And you can't really get into some of the structural things that we found is a proprietary and as I mentioned, they've even led to some new intellectual property. But what we do know is that relationship with the clinical data that Steve presented is something that's very notable and we have very, very high confidence that what happened in JMP 2 and 5 those two lots really is not happening anymore with moved well beyond that with our control strategy that we are implementing into the commercial manufacturing.

Andy T. Hsieh -- William Blair & Company -- Analyst

Great. Okay. And is it consistent. I didn't have time to kind of look overall be different histologies but is it, is it consistent and is it true that it seems like bempeg and in-dose cohorts did not actually contribute to any meaningful efficacy that, is that kind of a true statement based on your observations?

Unidentified Speaker

Yeah. So based on our analysis of the data. Yeah. Patients that started lots 2 and 5 they looked more like nivo monotherapy would look. That's exactly right. That's what the data is indicating.

Andy T. Hsieh -- William Blair & Company -- Analyst

Okay. And so do you mind reminding me kind of mentioned about a Fleming analysis in the non-small cell lung cancer. I I didn't really quite get that do you might, kind of reminding me with what's going on there?

Mary Tagliaferri -- Chief Medical Officer

Yes. So obviously to look at the Fleming, we have to have fully enrolled cohorts and we haven't yet fully enrolled to0 the maximum number of patients to analyze the Fleming, so once we do that we will find a conference to present those data and that was specifically the reason why when we spoke to the investigator who submitted the abstract to ESMO she did not want to present the data as we don't have a complete dataset. And the data are too immature at this time to analyze the Fleming.

Andy T. Hsieh -- William Blair & Company -- Analyst

Oh, got it, OK. Now, I get it. Thank you. Thank you very much and yeah -- OK, got it. Cool. Thank you very much for answering all my questions.

Operator

Thank you. Our next question comes from David Steinberg from Jefferies. Your line is open.

David Steinberg -- Jefferies & Company Inc. -- Analyst

Thanks very much. I know the clear focus of the call today is on bempeg in oncology. But given the unusual General Advice Letter you got from the FDA a couple of weeks ago, the delay for the Adcom and your comments at the top of the call. I just had two questions on 181. The first regard your NDA filing. So I know that the letter you got from the FDA was only four weeks away from the PDUFA date. So, could you comment by that time usually there is labeling discussions going on. Could you comment as to whether you actually engaged in some level of label discussions. And secondly, were all the manufacturing sites cleared.

And then the second question relates to the JV. I think you said you're seeking equity partners. Do we assume that the equity partners will sign up assuming FDA approval or if you get FDA approval and you don't get all the equity partners you want will the company underwrite at least part of the JV on its own. Thanks.

Stephen K. Doberstein -- Chief Research & Development Officer

Okay, thanks. Well, look, you first -- your first question was very insightful. And the answer is yes, we are having labeling discussions with the agency regarding NKTR-181 and they continue to review the NDA and we're still hopeful that we, we have an Adcom and a result by the end of the year. There are no manufacturing issues, no CMC issues. We've been fully reviewed there has been nothing that's come up there. So I don't see that as an issue in terms of financing. Look, I think you can imagine that you're not going to have capital partners put in significant capital prior to at a minimum, an Adcom or approval. But I think everybody recognizes how important this drug is, in going toward solving the opioid crisis. It is a major component of solving the opioid crisis for our country. And I think everybody recognizes it. I think the FDA hopefully recognize it and I think at some point capital will be accessible, but I clearly think that we're going to have to at least have an Adcom first before, before anybody commits. I'm not, terribly concerned about that I think will make that happen.

We've set up an important subsidiary in Harris with a, with a great management team who is absolutely focused on making this, bringing this drug to market in a very, very important way and like I said, like I said, it's very encouraging that we are continuing labeling discussions with the agency.

David Steinberg -- Jefferies & Company Inc. -- Analyst

Great, thanks.

Operator

Thank you. Our next question comes from George Farmer from BMO Capital Markets. Your line is open.

George Farmer -- BMO Capital Markets Equity Research -- Analyst

Hi, thanks for taking my questions. So given that the enrollment in non-small cell lung cancer is going slowly and it seems like a lot of the patients in your trial as well as in the urothelial cancer trial got these batches 2 and 5. What gives you confidence that you're registrational trials will be positive in those two indications.

Stephen K. Doberstein -- Chief Research & Development Officer

Well, look in non-small cell lung cancer, we haven't yet talked about our registrational trial pathway there. So stay tuned, I think as that data emerges and is -- as it continues to evolve, will be able to say more about that. I think when we look across the totality of the bladder cancer dataset. And in particular, the number of deep responses that we see and the duration of those responses. I think we feel pretty good about our bladder cancer performance against the standard of care in the landscape right now.

George Farmer -- BMO Capital Markets Equity Research -- Analyst

All right, but sorry, is in the second line trial in lung cancer, one of the four trials is in that going to be used for registration?

Mary Tagliaferri -- Chief Medical Officer

Yeah, hi, this is Mary. Yeah. Just two things, one, when we look at bladder cancer, even when you look at the pool data, we still have a complete response rate that is twice as good as what you'd see with pembro or atezolizumab and then even when you look at our lots 1 and 3, you really see the half the patients responded and 42% of them actually had complete responses. So we do have tremendous confidence in our mechanism of action and in the bladder cancer study and we look forward to the outcome of that. Now, with respect to the second-line non-small cell lung cancer at ASCO 2018. We did have Dr. Scott get injured go through three different cases, two of which were responders and the third one, which was having very meaningful clinical response and these were in patients who had previously been treated with IO agents and what was unique about that patient population is they also had responses to their initial I-O treatment. And so we modified that second line I-O refractory patient population, so that these patients could not have had primary refractory disease they could only have relapsed disease, meaning that they had 120 days of stable disease or better in order to come on to the trial and I can let JZ mechanistically explain why we feel that there is a rationale for that.

Jonathan Zalevsky -- Chief Scientific Officer

Yeah, thanks. Thanks, Mary. Yeah, the one thing that I'll add is, so remember like just as the key biomarker component, especially when you consider the urothelial carcinoma, remember that we showed a very high frequency at PD-L1 conversion in that population, which is why, of course, that is a PD-L1 negative readout kind of a study. We provided that mechanistically. And the key was that, that was data that we showed with the entire cohort of patients. So even though we are noting the sort of differences between lots and we're applying that to a registration strategy. We still believe that there is enough confidence from the data that we have that progressing into the registrational program we have a good opportunity to be successful.

Mary Tagliaferri -- Chief Medical Officer

Yeah, and George and just closing this conversation. The two responders that we did see started on lots 1 and 3 again providing the confidence that will see efficacy in this patient population.

George Farmer -- BMO Capital Markets Equity Research -- Analyst

Okay. And then at SITC when you present the melanoma data. Are we going to see the whole intent to treat population or are you going to break out the patients based on a lot of drug that was received?

Mary Tagliaferri -- Chief Medical Officer

Yeah. So we haven't prepared the presentation yet, but obviously we've always shown pool data and we have the opportunity, an agreement with BMS to show the data by first slot that's been received. So we do have that possibility and we shared with you today. The response rate at first scan as well as the best overall response so far in that population. Again I just want to emphasize that our breakthrough therapy designation was based on the pooled data between lots 1 and 3 and lots 2 in 5 and the FDA we're fully aware of these differences that we've seen between lots when they reviewed the BTT document.

George Farmer -- BMO Capital Markets Equity Research -- Analyst

Okay. Great. And one more quick question in the REVEAL trial with NKTR-262 -- agonist which batch was used in that study?

Unidentified Speaker

Hey George, this JV that we used batch for in that study, which is OK, not a about that was used in PIVOT, but from a characterization point of view badge 4 resembles lots 1 and 3 or batches 1 and 3 from PIVOT

George Farmer -- BMO Capital Markets Equity Research -- Analyst

Okay, great. Thanks very much.

Operator

Thank you. [Operator Instructions] And our next question comes from Daina Graybosch from SVB Leerink. Your line is open.

Daina Michelle Graybosch -- SVB Leerink LLC -- Analyst

Hi, thank you for the questions, the first one on TNBC and the CRI could we interpret from your comments on the potential registration trials as well as breaking down the lots that you did not see a promising efficacy signal in the syndication?

Mary Tagliaferri -- Chief Medical Officer

Yeah, hi, since we're presenting data at the quadruple meeting in September. We didn't go through all of the data presentation but we look forward to sharing those data with you in Paris at the CRI quadruple meeting in September .

Daina Michelle Graybosch -- SVB Leerink LLC -- Analyst

Great. And then a question on follow-up for JV, you talked about the mathematical modeling to compare the lots. Have you had the opportunity to do any pre-clinical experiments lab experiments to validate that and then all your previous preclinical work, do we know what lots. Those were done with?

Jonathan Zalevsky -- Chief Scientific Officer

Yeah, hey, Daina, this is JZ. So, as we mentioned, we did discuss the control strategy with the FDA and so there was a lot of data that was necessary in order for that discussion, because we had to present to the FDA, all the things that our findings, I can't get into the details of that though, because as I mentioned earlier that's proprietary to our molecule and to our company and it's even led to some new intellectual property that we filed. So I can get into some of those details, but to your other question, then in terms of the batches used for the earlier preclinical studies, including our own publications. Yeah. So, as we've described what we observed in lots 2 and 5 was historical really an outlier compared to all of the other batches we identified where we didn't see those kind of differences. So the material that we use, even in our early research early discovery campaigns, it was material that was more representative of lots 1 and 3.

Daina Michelle Graybosch -- SVB Leerink LLC -- Analyst

Got it. And then one last question. Which lots did you use in the single agent dose escalation data? Was that anything from these problematic lots?

Jonathan Zalevsky -- Chief Scientific Officer

Yeah, this is JZ again. Yeah, it was a lot, one that was used in the single agent in the Excel monotherapy trial and also the dose escalation part of PIVOT 2 that also used lot 1.

Daina Michelle Graybosch -- SVB Leerink LLC -- Analyst

Actually one more question. This is a huge investment, both you and BMS have in all these registration trials, would you consider repeating any of the cohorts to get a sample and any of these ongoing registration trials quicker that was clean with good lots?

Stephen K. Doberstein -- Chief Research & Development Officer

Well, I don't. Yeah, no, I don't, I don't think that's the plan. I think we believe that we've identified the root cause can never prove causality, but we believe we understand what's happened and we already have, as I said three registrational trials running. We know the lots that are going into the clinic now for all the registrational trials look like lot 1 and lot 3 and as I said, no one in the registrational trials ever received lot 2 or 5.

So there, there is no reason to slow things down. And as you know, the landscape is also dramatically changing in a rapid basis kind of rapid way in the field of immuno-oncology. So slowing things down to do additional homework, so to speak. I don't think is particularly attractive here and I don't think there's really any need for it. We have some very, very clear results in a number of these studies. Look at melanoma for example, here you have breakthrough status in first-line melanoma, which is a pretty significant accomplishment. So we're going to, we're going to move ahead with these studies in a registrational trial setting and get bempeg to market as quickly as we can.

Daina Michelle Graybosch -- SVB Leerink LLC -- Analyst

Okay. Thank you.

Operator

Thank you. And I am showing no further questions from our phone lines and I'd like to turn the conference back over to Howard Robin for any closing remarks.

Howard W. Robin -- President and Chief Executive Officer

Well, thank you. Thank you for joining us today. Everyone I know you'll have some more questions at a later date. There was a lot of information provided, but we're happy to set up one on one meetings and discuss this with you in more depth, if you need to understand it better. And I want to thank all of our employees who I know are working very diligently on all the task that way ahead of them. So thank you for joining us this afternoon.

Operator

[Operator Closing Remarks]

Duration: 72 minutes

Call participants:

Jennifer Ruddock -- Senior Vice President of Investor Relations & Corporate Affairs

Howard W. Robin -- President and Chief Executive Officer

Stephen K. Doberstein -- Chief Research & Development Officer

Gil M. Labrucherie -- Senior Vice President and Chief Financial Officer

Jonathan Zalevsky -- Chief Scientific Officer

Mary Tagliaferri -- Chief Medical Officer

Unidentified Speaker

Chris Shibutani -- Cowen & Co. -- Analyst

Jessica Fye -- JP Morgan Chase & Co. -- Analyst

Tyler Van Buren -- Piper Jaffray -- Analyst

Tyler Martin Van Buren -- Piper Jaffray Companies -- Analyst

Paul Choi -- Goldman Sachs Group Inc. -- Analyst

Alex Lim -- Mizuho Securities -- Analyst

Robert C. Hazlett -- BTIG -- Analyst

Andy T. Hsieh -- William Blair & Company -- Analyst

David Steinberg -- Jefferies & Company Inc. -- Analyst

George Farmer -- BMO Capital Markets Equity Research -- Analyst

Daina Michelle Graybosch -- SVB Leerink LLC -- Analyst

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