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Nektar Therapeutics (NASDAQ:NKTR)

Q3 2010 Earnings Call

November 4, 2010 5:00 PM ET

Executives

Jennifer Ruddock – Investor Relations

Howard Robin – President and CEO

John Nicholson – Chief Financial Officer

Bharatt Chowrira – Chief Operations Officer

Dr. Lorianne Masuoka – Chief Medical Officer

Steve Doberstein – Chief Scientific Officer

Analysts

Ian Sanderson – Cowen and Company

Jonathan Aschoff – Brean Murray

John Sonnier – William Blair

Shiv Kapoor – Morgan Joseph

Bert Hazlett – BMO Capital Markets

Operator

Good day, ladies and gentlemen. Welcome to the Third Quarter 2010 Nektar Therapeutic Conference Call. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session. (Operator Instructions)

I would now like to turn the presentation over to your host for today’s call, Ms. Jennifer Ruddock. Ma’am, you may proceed.

Jennifer Ruddock

Thank you, Kristine. Good afternoon. And thank you for joining us for Nektar Therapeutic’s third quarter 2010 financial results call. With us today are Howard Robin, our President and CEO; John Nicholson, our Chief Financial Officer; Bharatt Chowrira, our Chief Operations Officer; Dr. Lorianne Masuoka, our Chief Medical Officer; and Steve Doberstein, our Chief Scientific Officer.

Before we get started, please note that in our presentation and in our response to questions today, we will make forward-looking statements that reflect our current views as to the value and potential of our technology platform, the progress and potential of our drug candidates, the timing of the start of clinical trials, the timing and potential for a partnership of NKTR-102, the economic potential under certain of our agreements, the market potential for certain of our drug candidates, our financial guidance for 2010 and other future events and opportunities related to the company.

These forward-looking statements involve significant risks and uncertainties that are detailed in Nektar’s reports and other filings with the SEC, including our Form 10-Q quarterly report filed with the SEC on July 28, 2010, our report on Form 8-K filed today and our Form 10-Q quarterly report filed today.

Actual events could differ materially from these forward looking statements. We assume no obligation to update any forward-looking statements as a result of new information or future events. A webcast of this call will be available for replay on the Investor Relations page of Nektar’s website at nektar.com.

With that, I will now hand the call over to our President and CEO, Howard Robin. Howard?

Howard Robin

Thank you, Jennifer. Thanks everyone for joining us today. 2010 continues to be an exceptional year for Nektar. We have made significant progress in advancing an impressive pipeline of high-value therapeutics, including mid to late stage development programs in oncology and pain.

Through continued productivity in R&D, Nektar’s pipeline has both expanded and matured significantly. We now have over 25 therapeutic programs in our pipeline from candidates and discovery to those preparing for Phase III. Each of our candidates is designed to address an important clinical need and a significant commercial opportunity. Under pinning all of these of accomplishments, is a powerful and validated polymer conjugate technology platform that continues to generate exciting new drug candidates.

Today I will review Nektar’s achievements in the last quarter and update you on NKTR-102, NKTR-105, NKTR-181 and selected partnered programs. John will review our financial results and guidance, and then we will take your questions.

Before I review the progress of our key programs, I’d like to comment briefly on the recently announced Amgen agreements. While the exact terms of this non-exclusive contract are confidential, we are exceptionally pleased with this agreement which was outlined in the 8-K filed this week.

We will receive $50 million and we will now make reasonable margins on any future orders from Amgen. As a result, we are increasing our year-end cash guidance to reflect the $50 million payment we will receive from Amgen. We now expect to end 2010 with a cash balance of approximately $315 million. Please note that this guidance does not include the potential cash from a Nektar-102 partnership.

Now more importantly, let’s talk about Nektar-102. As you know, we continue to be very excited about NKTR-102 and its compelling activity as a single agent in a number of tumor cells. We are currently in active negotiations to partner NKTR-102 and we expect to enter into a partnership around the end of this year.

We remain committed to entering into a collaboration that maximizes the value to share holders and brings Nektar-102 to physicians and patients as quickly as possible.

Chemotherapies represent a $12 billion global market and they’re use to works that of targeted agents, many of which need chemotherapies to work. As a class though, these agents typically have very short half lives and the Cmax related toxicities, which limit their utilities. It has long been hypothesized that if you can improve the PK profile of a chemotherapeutic agent, you can address limitations of the class and have a very potent anticancer drug.

With NKTR-102 we have successfully created a new topoisomerase I-inhibitor, with optimized PK properties, with the goal of increasing its efficacy and improving its tolerability.

Nektar-102 was specifically designed to have an extended half life that can also achieve greater penetration into tumors. So the agent can have maximum impact on continuously dividing cancer cells. NKTR-102 was also designed to be efficacious with a lower Cmax, which reduces the Cmax related toxicities.

The positive efficacy data that is continuing to emerge for NKTR-102 in the breast and ovarian cancer settings highlights the drug significant potential to provide great benefits to cancer patients. We have seen these highly promising results for NKTR-102 in some very difficult to treat cancer cells.

NKTR-102 is currently in multiple clinical trials, including the expanded Phase II trials in women with platinum-resistant ovarian cancer that have had prior Doxil treatments, a Phase II trial in women with metastatic breast cancer, and two additional studies in the colorectal cancer setting, as a single agent and as part of the combination regimen.

Earlier this year as you will recall, impressive results for NKTR-102 from our ovarian cancer study were presented by Dr. Vergote at the old gynaecologic oncology session at ASCO.

I’m pleased to tell you today that we’ve also been invited by a prestigious oncology journal to submit the final data from the 71 patients in the original Phase II study with a targeted publication date in the first half of 2011. The data from our ovarian cancer studies indicate that NKTR-102 is a highly active agent with a good tolerability profile in heavily pre-treated chemo-resistant patients, a population for which there is no good standard of care today.

The sad fact about ovarian cancer is that although most women respond well initially, the platinum based therapies in almost every case platinum therapies stop working and women eventually become resistant and refractory to these agents. The more platinum-resistant the patient become, the less likely they are to respond to any other therapies.

Among patients consider platinum-refractory expected response rates are close to zero. 71% of the patients in the NKTR-102 study had progressed within three months of their last platinum dose and were clearly platinum-resistant. And almost half of the patients were actually platinum-refractory, which means they did not achieve any benefit from their last platinum-regimen.

In addition, none of these patients had a good quality response to a prior platinum base regimen. Impressively, about half of these women had a clinical benefit from treatment with NKTR-102.

We also observed in exceptionally high response rate among women who failed Doxil therapy, which is currently the most widely used treatment for platinum-resistant ovarian cancer. This is important as there are no reasonable affective therapies for these women whose disease has not responded well to either platinum or Doxil.

A high objective response rate in this population of (inaudible) chemo-resistant patients led to the expansion of our Phase II study to enroll 50 more platinum-resistant patients for failed prior Doxil. This expansion is designed to give us the option to pursue an accelerated approval for NKTR-102.

As I’ve said before, approval by the FDA prior to completion of phase three is uncommon. However, we think it is important to pursue this option, given the extraordinarily high response rates seen among these patients for which there are no other viable therapies.

The enrollment of the Phase II expansion arm is proceeding well and received a high level of investigator support. Of course, we’re also planning Phase III trials for NKTR-102 concurrent with our partnering discussions.

Now let’s spend a few minutes on NKTR-102 in breast and colorectal cancers. The study of NKTR-102 in metastatic breast cancer enrolled a total of 70 patients. Approximately 85% of these patients had prior anthracycline and taxane based therapies, with or without capecitabine, which is the most widely used front-line treatment in metastatic setting.

Some patients that have undergone AT or ATC regimens initially respond to their next regimen, but the great challenge in breast cancer is that tumors tend to rapidly develop resistance. As a result, there is an urgent need for new agents with a differentiated mechanism of action in this tumor setting. NKTR-102 has the potential to become the first topoisomerase I-inhibitor used to treat metastatic breast cancer.

In June, we released preliminary data from 66 patients in our 70 patient Phase II study, showing confirmed and unconfirmed responses of 18% for the Q-14 day regimen and 24% for the Q-21 day regimen.

Current results from this ongoing trial are showing even greater activity for NKTR-102 than what we were seeing earlier in the summer and we will be announcing very important findings from this study at the upcoming San Antonio Breast Cancer Symposium in December.

In the colorectal cancer setting, our Phase II clinical trial continues to progress. The randomized 174 patient study is evaluating NKTR-102 against Irinotecan in second line colorectal patients, whose tumors have the K-RAS gene mutation. As you know, we are also enrolling our Phase I study of NKTR-102 in combination with 5FU-leucovorin. Both of these studies are designed to support our ultimate goal of replacing Irinotecan whereever it is used in colorectal cancer.

The activity and safety profile of NKTR-102 has surpassed our expectations time after time in multiple studies involving different tumor types. We’ve had unusually high activity with NKTR-102 in our Phase I study in solid tumors. In fact, it was noted by Dr. [Von Hoff], our Phase I investigator, that NKTR-102 is the most highly active agent he had studied in all of the 318 Phase I studies, he’s conducted at his center.

Then we achieved high response rates with NKTR-102 in the most difficult-to-treat populations, in platinum-resistant ovarian cancer. Now, we are seeing compelling results emerging from NKTR-102 in metastatic breast cancer. It is clear that NKTR-102 is a highly active anticancer agent and has the potential to be developed in multiple tumor settings.

NKTR-105, a novel antimitotic polymer conjugate is our next clinical stage oncology compound. We are conducting a Phase I study of NKTR-105 in advanced solid tumors. We expect to complete the dose escalation portion of the study in the coming weeks as we are at or very near the recommended Phase II depths.

We will then be expanding the number of patients at this dose to better inform our Phase II studies, which we plan to initiate in the second half of 2011. At the highest dose levels in the Phase I studies for NKTR-105, we continue to demonstrate that NKTR-105 has a markedly reduced Cmax and a significantly prolonged half-life of approximately 20 days, as compared to docetaxel’s half life of about four days, allowing us to provide continuous exposure of drug to tumor in a typical three-week cycle.

What we have accomplished with NKTR-102 and NKTR-105 could be achieved with the widest range of small molecule chemotherapeutics and Nektar is developing a portfolio of new anticancer candidates that leverage our polymer conjugate technology’s. We look forward to sharing more about these programs as we move towards I&D stage.

Now, moving onto our next exciting drug candidate, which is an area of pain, NKTR-181. This new opioid molecule is gaining significant visibility within the pain community, from both researchers and practitioners alike. While opioid analgesics clearly represent the gold standard in pain control, existing opioids pose significant safety risks. Their misuse, abuse and safety risks have been cited as serious public health issues by the FDA and the medical community.

NKTR-181 is the first opioid analgesic candidate with a novel molecular structure that is specifically engineered to address the safety risks and abuse liability of the opioid class of pain killers. The unique chemical structure of NKTR-181 results in a significantly reduced rate of entry into the brain.

In our preclinical models, this slower rate of entry mitigates the physiological basis for addictive behavior by reducing euphoria. In addition, the slower rate of entry also reduces side effects, such as sedation and respiratory depression commonly associated with common opioids.

Nektar scientists recently presented pre-clinical data for NKTR-181 at two prestigious pain conferences. An oral presentation at the Frontiers of Pain research meeting and a poster presentation at the 2010 annual American Society of Anesthesiologist meeting. We look forward to presenting additional data for NKTR-181 at the Meeting of Society of Neuroscience in mid-November.

As the data emerged for NKTR-181, we are increasingly excited about its potential to address a serious need for analgesic that offers physicians a solution to provide potent pain relief to patients, without the serious risks associated with the opioid class. According to the American Pain Society, approximately 105 million Americans or 36% of adults, suffer from chronic pains.

The U.S. opioid market alone is a $10 billion market. We believe NKTR-181 is well positioned to dramatically advance the field of pain management and to target this large and growing market. We are completing IND enabling studies for NKTR-181 and expect to be initiating our first human studies in the first quarter of 2011. Our Phase I developing program will include endpoint of efficacy as well as patients.

Now, I’d like to discuss two other pain candidates in preclinical development, NKTR-171 and NKTR-194. NKTR-171 is being developed to treat neuropathic pain, while eliminating adverse CNS related side effects such as sedation, dizziness and seizures that are found with current therapies. NKTR-194 is an opioid that is entirely excluded from the CNS and is prefereably acting. It’s being developed to treat mild-to-moderate pain, potentially taking the place of NSAID and COX-2 inhibitors.

Finally, I’d like to give a quick update on NKTR-118. As we said on our last call, AstraZeneca is currently preparing for the Phase III trials, which should start in early 2011. To remind you, the AZ collaboration includes both worldwide rights to both NKTR-118 and 119. And Nektar has the potential to receive upto $1.3 billion in milestone payments for these programs as well as significant double-digit royalties on product sales.

As we look towards 2011, Nektar is well positioned for continued success. I truly believe we have done a remarkable job in building our portfolio, with more than 25 drug candidates in our pipeline ranging from discovery to those preparing for Phase III clinical trials. Furthermore, each of our products addresses a significant clinical need and represents a major commercial opportunity.

We have a successful track record of forming high-value partnerships that provide significant up-front payment in milestones, while maintaining significant economic ownership in our programs. More importantly, we have created a powerful and validated technology platform that continues to generate promising large and small molecule therapeutic agents.

With that, I’d like to turn the call over to John for review of the third quarter financials.

John Nicholson

Thank you, Howard and good afternoon everyone. We ended the third quarter with $303.3 million in cash. Revenue in the third quarter increased to $37.9 million as compared to $10.2 million the same quarter a year ago. This increase was primarily related to the amortization this year of $100 million to $125 million payment we received from Astra Zeneca late last year.

As we’ve said on past calls, the amortization of this payment is expected to be completed by year-end in conjunction with the completion of the technology transfer to AstraZeneca for manufacturing of NKTR-118. Research and developing expenses in third quarter 2010 increased by 20% to $27.7 million versus $23 million in the third quarter 2009.

This increase represents higher R&D spend related to advancing our clinical and preclinical development programs. Because of this increase in R&D expense, total operating costs and expenses in third quarter were $44.2 million as compared to $39.1 million in the third quarter a year ago.

Now, onto guidance for the year. We still anticipate revenues of between $155 million and $160 million including the amortization I just mentioned of approximately $100 million on the upfront payment of $125 million received from AstraZeneca in 2009. R&D expense for 2010 is still estimated to be between $110 million and $115 million, an increase over the $195 million spent in 2009.

Development expense for 2010 include a continuing investment into our Phase I clinical study of NKTR-105 and Phase I and II of the NKTR-102 in ovarian, breast and colorectal cancers. In addition, these expenses include the extension of Phase II trials for NKTR-102 and ovarian cancer and the manufacture of NKTR-102 Phase III clinical supply. Our research expenses also include preclinical studies in new pain and oncology content as well as a continued activity necessary to bring NKTR-181 into human studies.

G&A expense for 2010 is still estimated to be approximately $41 million essentially consistent with 2009 levels. Included in this amount is approximately [$30] million in non-cash items consisting mainly of depreciation and stock compensation expense.

Capital expenditure for ongoing operations is still expected to be $10 million for 2010, also is expected (inaudible) which were projected to be approximately $25 million proceeded on budget and according to schedule for Nektar’s new Mission Bay research and development center in San Francisco.

As we had said previously we anticipate moving into this facility by the end of this year. As a reminder under the terms of lease, we will not pay any rent for this facility until August 2013.

As Howard mentioned our year-end cash (inaudible) increased by $50 million in light of the recently signed agreement that Amgen announced this week. The cash at year end is now expected to be approximately $315 million. However, please note that this anticipated year-end cash balance does not include any potential payments related to NKTR-102 partnership.

With that I will now open the call to questions. Operator?

Question-and-Answer Session

Operator

Thank you, sir. (Operator Instructions) Our first question comes from the line of Ian Sanderson from Cowen and Company.

Ian Sanderson – Cowen and Company

Can you hear me?

Jennifer Ruddock

Yeah. We can hear you, Ian. Go ahead.

Ian Sanderson – Cowen and Company

Okay. Thanks. So, can you talk a little bit about the animal model that was used to demonstrate modulation of the rate at which NKTR-101 crosses the blood brain barrier? And I don’t know if you know whether that has been replicated in human studies, and this seems like a very interesting finding and I am just trying to figure out how powerful the validation of the animal study is?

Steve Doberstein

Hi. This is Steve Doberstein. So, those animal studies that measured the rate of crossing of the blood brain barrier are all commonly performed in rats. They’re pretty standard studies that are very well validated and very well correlated with other animal studies. There haven’t been any human clinical studies with NKTR-101 yet, so it’s not possible for us to comment on how well that’s going to correlate.

Ian Sanderson – Cowen and Company

Okay. And if I could also ask, Howard, I may have missed this at the beginning of the call, but did you give an update on the colorectal cancer studies of 102?

Howard Robin

No, Ian. What we said was that the studies are ongoing. We are continuing our Phase II study comparing NKTR-102 over to Irinotecan and the KRAS gene mutation population. And we’ve also started a study in combination with 5-FU/leucovorin and we don’t have any data yet on those studies to give out.

Ian Sanderson – Cowen and Company

Okay. And then finally, just if you could give us a quick snapshot of what milestones we should be looking for, or what may be announced by AstraZeneca on NKTR-118, NKTR-119 in 2011?

Howard Robin

Well, you know, I can’t speak for them at this point. I can tell you that we’ve said that we expect the Phase III trials to start in early 2011. I can’t give you a specific date, that’s actually up to AstraZeneca. And I imagine when those trial start, we’ll issue some announcement on that, but beyond that, that’s all I can tell you at this point under the contract.

Ian Sanderson – Cowen and Company

Okay. Thank you.

Operator

Our next question comes from the line of Jonathan Aschoff from Brean Murray.

Jonathan Aschoff – Brean Murray

Hi, guys. Thanks for the questions. I have four. Did I miss the Phase I timings for NKTR-105 or did you not stay that?

Howard Robin

Well we said we were very close to the maximum tolerated dose and we will be starting Phase II in the middle of next year. We will be announcing the Phase I results either later this year or early next year.

Jonathan Aschoff – Brean Murray

Okay. I was wondering what kind of efficacy are you initially looking for with 181 in the clinic?

Howard Robin

Well let me turn that question over to Dr. Masuoka can answer.

Lorianne Masuoka

So for the 181 program, the key objective of the initial set of studies is to demonstrate equal analgesia with the reference opiate compounds. So those are basically represented by very straightforward pain studies.

Another very big goal for us it’s also to demonstrate a superior safety profile of course. So we’ll be looking at the kinds of things that one normally would expect to see with regard to adverse effects that you would normally expect to see with opioids and we’ll be looking to see how NKTR-181 compares against that profile.

Jonathan Aschoff – Brean Murray

Okay. And what other opiates would be most helpful to have, as an alternative to 181 and have you run into any technical barriers trying to modify those other opiates compared to the time you had on the modification 181?

Howard Robin

Well, we haven’t said specifically which opiate it is, and there could also be various flavors of opioids. So while we haven’t identified the specific opioid, I think this technology could be applied to a number of different opioids. Steve would you like to comment on that further?

Steve Doberstein

Yeah. I’d be happy to. So the CNS exclusion technology that we’ve been talking about that underlines NKTR-181 works across a very broad set of molecular scaffold. And that certainly includes all of the clinically significant opioids. So, you can imagine that gives us an array of molecules to work with.

We’ve talked about NKTR-181, we’ve talked about NKTR-194 and we, of course, continue to assess what are the real clinical differentiators that one could find, that might allow us to apply the technology to even other opioids on top of that. So, stay tuned. We continue to look at that. It’s really more of a question of what’s the real clinical differentiators for those molecules, and how would they fit into the portfolio.

Jonathan Aschoff – Brean Murray

Okay. And then outside of 171, can you help us understand the opportunity beyond that, kind of a within an outside neuropathic pain with non-opioid drugs that have higher efficacy, but have a lot of CNS-driven toxicity? Therefore they would kind of seriously benefit from a CNS exclusion?

Lorianne Masuoka

Yeah. I’ll take that one. This is Lorianne. So, clearly that program is specifically geared towards polymer conjugation of a product that would be best suited to treating neuropathic pain. Now having said that, there are a myriad of opportunities for treating peripherally based disease states, in which one of the downsides of currently available therapy are the CNS side effects.

And, so in those cases, clearly NKTR technology could be greatly applied to producing superior new therapeutics. We are entertaining quite a number of those ideas and some of those are part of our early preclinical pipeline.

Jonathan Ashcroft – Green Murray

Okay. Thanks a lot.

Operator

And our next question comes with a line of John Sonnier from William Blair.

John Sonnier – William Blair

Thanks for taking the question and Howard congrats on a lot of progress over there. Just a couple of questions on NKTR-102. It sounds like things continue to go very well there. Your guidance has been to do a transaction strategically this year. You’re well-capitalized, why don’t you just hang on? Hang on for another six months or a year if the data is coming in strong?

Howard Robin

Well, I think this. Good question. But I think there’s a great desire to see these programs move rapidly. NKTR-102 for ovarian cancer is ready now for Phase III. And what we don’t want to do is delay that another six or nine or ten months.

The other thing you should realize though, is that while the data is coming and we can’t share it with you, of course. Publicly, the companies that we are negotiating with and that are completing their diligence get to see all the data. So they’re right up-to-date with the data that we have today. So they already understand what the data looks like completely in breast cancer and ovarian cancer.

And even the data, we have so far in colorectal cancer. So that is made fully available to them. So a combination of the fact that they already know exactly we are, together with the fact that I’d like to see this progress rapidly in terms of moving ovarian cancer into Phase III, is a good reason not to wait.

John Sonnier – William Blair

That’s a great answer. Lorianne, talk a little bit about the filing strategy on this Phase II extension study with 102. I think Doxil was approved in the resistance setting -- what I believe less than 120 patients. Talk about what your data set looks like when you get ready to file and what you’re actually asking for. Is it going to be Doxil failures? Is it going to be resistance and refractory patient’s? How broad a claim are you going to ask for?

Lorianne Masuoka

So, I think just, generally speaking, I can’t really -- for competitive reasons I can’t tell you exactly what all the details are of our regulatory strategy. But what I can say generally and if you remember back to the data that we presented at ASCO, there was a really good rate of response to NKTR-102 in patients who were not only platinum-resistant but also had failed prior Doxil.

And while Doxil is approved for use in the platinum-resistant setting, as is topotecan, there really aren’t any good agents that have good efficacy in the setting of patients who are platinum-resistant but who’ve also failed Doxil, i.e. in this double chemoresistant population.

In general the FDA could consider, as an area of unmet medical needs, a patient population that you’ve specifically identified for whom there is no good current therapy. And a lot of what we are doing with the expansion specifically addresses, what we think the FDA will be looking for in terms of that specific population.

John Sonnier – William Blair

Okay. That’s helpful. Thanks so much.

Operator

(Operator Instructions) We have a question from the line of Shiv Kapoor from Morgan Joseph

Shiv Kapoor – Morgan Joseph

Thanks for taking my question. I’ve got a question on the NKTR-105. What are your expectations for Phase I data? Have you seen any signs of efficacy? And any ideas yet on Phase II design?

Howard Robin

I’m going to let Lorianne answer that question for you.

Lorianne Masuoka

Yeah. Just to remind everyone the design of the Phase I study for NKTR-105 is what’s called a classic three plus three design. So basically patients are enrolled in groups of three. And as you see good tolerability you then dose-escalate to some degree.

And due to regulatory requirements, we actually had to start that trial at a very, very low dose level. And so what we’ve been able to find so far, is that the drug has been extremely well tolerated, with regard to the usual kinds of things that you expect to see with (inaudible). So we are getting very close to identifying the recommended Phase II dose.

We’ve also announced today that we will be expanding the trial to include an additional number of patients at that dose level. Because we had to start at very low dose levels, there were quite a few patients who were enrolled at that very, very low dose. So what we want to do is get a number of patients that are in a more active range, such as what we are testing now, that will help us decide what to do with regard to our Phase II and what indications will be best suited for this product.

Shiv Kapoor - Morgan Joseph & Co

Great. Thanks a lot. What about Phase II design?

Operator

We have a question from the line of Bert Hazlett from BMO Capital Markets.

Bert Hazlett – BMO Capital Markets

Hi, thanks. It’s Jim Tumbrink for Bert. Thanks for taking the question. Howard, I know you said the publication of the ovarian cancer data -- I think in the first half of 2011 -- is that going to be including some of the extension data? Or is that going to be more complete data from what we saw at ASCO? And then secondly, just an update on Inhale Amikacin? Thanks.

Howard Robin

Yeah. Look. I think the data that you’ll see in that publication are essentially the finalized ASCO data. The finalized trial data. It won’t be the expansion data. Lorianne, would you like to comment on that further?

Lorianne Masuoka

No. That’s right. Given the timing of the partnership negotiations and discussions, what we will be publishing are the final results from the 71 patients that are in the original study. Obviously, the expansion group is ongoing at this time and is likely -- the data from that is likely to be released in collaboration with the partner.

Howard Robin

With regard to the Inhaled Amikacin program, it is moving forward. We are producing devices for buyer. The decision was made that we would not start that study until we had the final commercial device manufactured and engineered and indeed we’ve done that. We are in the process now of actually producing devices and I expect that buyer will start that study in the first portion of 2011.

Lorianne Masuoka

I’m sorry. We actually or I actually missed part of Shiv’s part question which related to the Phase II design for NKTR-105. So in general, I think you’ve seen the kind of Phase II studies that we designed. And to some degree, the specifics around the design will be determined by which indication we ultimately pursue for that product.

Operator

And we have no further questions. I would now like to turn the call over to Mr. Howard Robin.

Howard Robin

Well, thank you for joining us today. We at Nektar are committed to developing and discovering innovative and important new therapeutics and we have a track record of execution against our goals that speaks well to our future success. I continue to be exceptionally proud of Nektar’s employees and their achievements and I am very excited about our future. So stay tuned. We’ll talk to you again. Thank you. Good afternoon.

Operator

Ladies and gentlemen, we thank you for your participation in today’s conference. This concludes the presentation. You may now disconnect and have a great day.

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