Nov 5, 2010
Executives
Wade Walke – Senior Director of Communications and Investor Relations Arthur Sands – President and CEO Brian Zambrowicz – EVP and Chief Scientific Officer Jeff Wade – EVP, Corporate Development and CFO
Analysts
Matthew Lowe – JP Morgan Phil Nadeau – Cowen & Co. David [ph] – Stifel Nicolaus
Presentation
Operator
Welcome to the Lexicon Pharmaceuticals Third Quarter 2010 Conference Call. (Operator Instructions) At this time, I would like to introduce your host for today’s call, Wade Walke, Senior Director of Communication and Investor Relation.
Please go ahead, Dr. Walke.
Wade Walke
Good morning. Welcome to Lexicon Pharmaceuticals third quarter 2010 conference call.
I am Wade Walke. With me today are; Dr.
Arthur Sands, Lexicon’s President and Chief Executive Officer; Dr. Brian Zambrowicz, Lexicon’s Executive Vice President and Chief Scientific Officer; and Jeff Wade, Lexicon’s Executive Vice President of Corporate Development and Chief Financial Officer.
We expect that you have seen a copy of our earnings press release was distributed this morning. During this call, we will review the information provided in the release, provide an update on our clinical programs, and then use the remainder of our time to answer your questions.
The call will begin with Dr. Sands, who will discuss our key accomplishment for the third quarter.
Dr. Zambrowicz will then discuss the status of our drug development programs, and Mr.
Wade will review of financial results for the third quarter and discuss our financial guidance for 2010. We will then open the call to your questions.
If you would like to review the slides for today’s call, please access the lexicon’s website at www.lexpharma.com. You will see link on the homepage for today’s webcast.
Before we begin, I’d like to state that we’ll be making forward-looking statements, including statements relating to Lexicon’s research and development of LX1031, LX1032, LX1033, LX2931, and LX4211, and the potential therapeutic and commercial potential of those drug candidates. This call may also contain forward-looking statements relating to Lexicon’s future operating results, financial arrangements, cash and investments, discovery and development of products, strategic alliances and intellectual property, various risks that may cause Lexicon’s actual results to differ materially from those expressed or implied in such forward-looking statements including uncertainties relating to the timing and results of clinical trials and preclinical studies of our drug candidates are dependent on strategic alliances and ability to enter into additional collaboration and license agreement.
The success and productivity of our drug discovery efforts, our ability to obtain patent protection for our discovery, limitations imposed by patents owned or controlled by third-party and the requirements of substantial funding to protect our drug discovery and development activity. For a list and description of the risks and uncertainties that we face, please see the report we have filed Securities and Exchange Commission.
I will now turn the call over to Dr. Sands.
Arthur Sands
Thank you, Wade, and thank you everyone for joining us this morning. Over the past quarter, we have continued to advance our strategy and our pipeline.
Our strategy, of course, to discover and develop drug to the [inaudible] of novel mechanisms of action. Looking at our pipeline then, we’ll spend most of our time on the leading edge of our pipeline, these four programs.
The first tier ones, LX4211 for Diabetes and LX1031 for Irritable Bowel Syndrome, we have achieved of course peripheral concept and they vetted our next stage of development, a very important stage where we are working to prepare for latent stage development, working on form and formulation and other important studies that will preface the next step for those two programs. So, we’ll be discussing those.
Also, the next two programs that are up for proof of concept results, a very important Phase here, LX1032 for Carcinoid Syndrome and LX2931for Rheumatoid Arthritis. So, these being the next major events, I think major milestones for the company, we’ll start with those and review the data we expect and the timing for those milestones.
So, with that brief introduction, I will turn it over to Brian Zambrowicz to discuss first LX2931.
Brian Zambrowicz
Thank you, Arthur. I’m going to start with LX2931 because it’s a program for which we’ll be painting our next major clinical readout.
LX2931 is a first in class sphingosine-1-phosphate lyase inhibitor for autoimmune disorders. It’s part of the pathway that’s become increased interest especially with the recent approval of FTY720 or Gilenya from Novartis for Multiple Sclerosis.
Gilenya is S1P receptor agonist. I want to make it clear that we had a different plan in the pathway.
We had an intracellular target called the S1T lyase, which functions as to irreversibly degrade the endogenous second messenger S1P. The importance of getting this point in the pathway is both our pre-clinic and clinical data so far suggest that there’s a lymphoid [inaudible] when hitting the lyase that may provide a potential safety benefit.
2931 is an oral agent and we have preclinical data that there’s potential for this agent not only in arthritis, but also in other autoimmune disorders such as multiple sclerosis and transplantation. In addition, it’s generally thought that if you can show a benefit in patients with Rheumatoid Arthritis that suggest that there may be benefits in other autoimmune indication.
For 2931, one of the models, animal models that we really like was rat arthritis model that we ran. We like the model because we think it is very similar to the Phase 2A trial, where the Phase 2A trial is going into patients who are failing on methotrexate.
And in our arthritis model in rats, on the left you can see that with methotrexate alone, when we began treatment after the animals had reached the half maximal inflammatory response, methotrexate alone was not able to block the further inflammatory response. However, on the right, when methotrexate was given in combination with LX2931, it blocked the further progression of the disease model, and this does give us support for the concept that these two agents together maybe quite beneficial in a patient population failing on methotrexate.
So, our Phase 2A study for LX2931 is double blind placebo-controlled. And we’re – as I already mentioned, examining patients in combination with methotrexate.
You may recall that initially the size of the study was 120 patients. However, we did expand to 208 patients and in spite of that expansion, we enrolled very rapidly.
This is a large indication with many patients available. We ran a study in 46 centers in both the United States and Eastern Europe, testing three doses of LX2931; 70, 110 and 150 milligrams all given months per day.
It was a 12 weeks study, treatment period with a primary efficacy end point ACR20 every 12 – standard for an RA trial and multiple secondary end points including ACR50 1070 as well as DAF 28. All measured at the explore rate in 12 of dosing.
We do anticipate both receiving and reporting on the results of the study by yearend. Moving on to the Carcinoid Syndrome Trial, LX1032, as you may recall is a peripherally acting serotonin synthesis inhibitor.
It does inhibit the rate limiting enzyme for the production of serotonin, and serotonin is known to be a key mediator of the GI side effects of Carcinoid Syndrome. So, it drives both the diarrhea and GI cramping and discomfort that those patients feel.
In addition, there’s growing pre-clinical data that would suggest potential anti-tumor effects blocking serotonin synthesis. These patients also suffer overtime from right-sided cardiovascular issues that are also thought to be driven by serotonin.
So, there’s potential then for not only affecting the symptoms of Carcinoid Syndrome, but also potentially the tumor and cardiovascular side effects as well. We do have fast track status granted by the FDA and [inaudible] investigation by EMEA.
And with that, I want to move on to the description of the Phase 2A study. As you may recall we have two Phase 2A study.
It’s running – one is in Europe. It’s an open label study, where with every patient – we are dose escalating until we achieve a clinical benefit.
I’ll focus on the U.S. study because we believe we’ll be obtaining results for this study sooner.
The Phase 2A study in the U.S. consists of two parts.
The first part is double blind placebo-controlled dose escalation study. During this portion of the study, we’re looking at four separate cohorts of patients, and each cohort is a cohort of four with three on actives LX1032 and one patient on placebo, and we dose over 28 days and look for a benefit as far as affecting the GI symptoms of the Carcinoid Syndrome.
And then we move on to a separate cohort and dose escalates. We move through four cohorts starting on 150 milligrams given three times a day and going up to a high dose of 500 milligrams given three times a day.
After we complete that dose finding part of the study, we move on to an expansion cohort that consists of eight patients with six on active LX1032 and one on placebo. Then I’ll update you on the U.S.
study. We have completed enrollment of the dose escalation portion of the study and we are now in the process of moving on to the expansion cohort and we expect to commence that portion during this quarter.
Now, in the large indications like RA, as I already described as well as in our previous IBS study for LX1031, enrollment has been very rapid and efficient. In Carcinoid Syndrome, there is a low number of patients and that in combination with the fact that there are multiple competing trials has slowed our patient enrollment.
But as I have described, we’re moving into the final stages of this U.S. study.
In addition, the EU study is continuing. For both studies, we’re implanting a 24-week open label [ph] extension protocol.
It will allow us to continue to collect safety and efficacy data for the LX1032 compound. We do anticipate the results of Phase 2A study in the first quarter of 2011.
Moving on to the LX1033 program. Again, to remind you this is a locally acting serotonin synthesis inhibitor for IBS.
We have, as Arthur mentioned, previously achieved proof of concept in our Phase 2A study for LX1031 and patients with both diarrhea predominant and mixed IBS. We’re currently focusing on improving on the dose regimen, both lowering the dose and lowering the dose frequency.
With that in mind, we’ve been testing a couple of alternative formulations of LX1031, including a new polymer formulation as well as a nano particle formulation. In addition to that, we have been bringing forward a backup compound LX1033 for which we anticipate filing IND [ph] in December.
This is again a locally acting compound, very similar to LX1031. However, we think it may allow us to overcome some of the dosing issues that I’ve described because of the fact that it’s tenfold greater and potency in a biochemical assay against tryptophan hyrdoxylase target.
In addition, it has improved apparent solubility compared to LX1031. We would anticipate beginning the Phase 1 study that compound in the first quarter of 2011 and we do have the biomarker urinary 5-HIAA that can help guide us in determining whether we have made improvements in our dosing regimen.
Final program I wanted to update you on is LX4211 our dual SGLT2, SGLT1 inhibitor for the treatment of Type 2 Diabetes. We do believe this is potential best in class agent, if not clearly a first in class agent because of its still [ph] mechanism of action.
It is a once daily oral agent. Our Phase 2A trial results were very robust.
We saw large and rapid improvements in the control of blood glucose and that result into impressive HgA1c reductions over only four weeks of treatment. In addition, there were favorable trends in other metabolic and cardiovascular parameters including weight loss and triglyceride reduction as well as improvements in blood pressure.
Unlike the SGLT2 selective compounds, our dual inhibitor triggers what we believe are additional mechanisms due to inhibition of SGLT1 and we have shown trends of increase GLP-1levels and likely, there is other beneficial peptide being released from the gastrointestinal track, which may explain our enhanced glycemic control and very strong hemoglobin A1c effects. Just to remind you a little bit on our Phase 2A results.
I think the most significant observation was our effect on hemoglobin A1c. Of course, the effects are hemoglobin A1c reductions are the primary end points for Type 2 Diabetes trial.
We did get a very robust effect at four weeks with the 0.76% reduction in our high dose arm relative to placebo. We really are eager in our Phase 2B study to build upon this data.
A review of the historical data suggests that four-week hemoglobin in A1c reductions are approximately 50% of what you may expect at week 12. Then as we move forward then, we do want to see in the more definitive 12-week study what our HgA1c effects will be.
In addition, I think very unique to our compound and one of the things that we think is triggered by the SGLT1 inhibition of our compound, we did see a trend of increase in GLP-1 levels in both our dose arms relative to placebo. In graph, we have on the Y axis the total GLP-1 levels and on the X axis is the time and hours.
With the red arrows indicating the meals; breakfast, lunch, dinner and the bedtime snack. It’s typical that after a meal, you will get elevations in GLP-1.
They’re triggered by those meals. But what’s part apparent is that in both our dose arms, we have further elevations in GLP-1 levels over those observed in the placebo arm.
So, with these data in mind, we really thought it was essential that we rethink our PK/PD bioequivalence study and the information we want to glean from it. As you may recall, all of our studies to date has been done with a liquid formulation of LX4211 and in Phase 2B, we are desirous to move to a solid oral dose form.
With that in mind and our PK/PD study, we’re not only interested in looking at systemic exposure in PK and resulting effects on SGLT2 based on urinary glucose excretion, but we thought it was very important to modify the study to look at the mechanistic effects of what we think are due to SGLT1 inhibition. With that in mind, we also decided to measure GLP-1 levels as well as post-prandial or post-meal glucose levels in the blood and glucagons measures after each daily meal.
We have completed the dosing portion of this study, and we anticipate receiving the data from the study in December of this year with that data and the mechanistic results being reported in January of 2011. This information will guide us to identify the final tablet strength that we’ll want to be using in our Phase 2B study.
In addition, we’ve been doing further work on our Phase 2B planning. What we anticipate is a very robust study.
The doses set we plan to investigate would our two doses that we use in Phase 2A, so 150 and 300 milligrams of LX4211, each given once daily. But in addition to that, we want to explore a lower dose as well as a higher dose to make sure that we are maximizing the benefits that LX4211 compound.
In addition, we decided to incorporate an active comparator arm and for this active comparator, we’ve chosen saxagliptin or Januvia, a DPP-4 inhibitor and there are really two reasons for having this as a comparator arm. First of all, it’s the fastest growing second line agent that for adding on the metformin therapy.
In addition, it does act by prolonging the activity of GLP-1. This will be a 12-week study, very definitive study and as I mentioned, it’s a robust study.
We anticipate about 400 to 450 patients in the study. I think quite clearly having the 12-week HgA1c effect in this large number of patients as well as the active comparator arm will leave little doubt of the magnitude of our HgA1c effects relative to known agents.
To summary then, we do have several very important upcoming milestones for our programs. For LX2931, we do anticipate reporting on our Phase 2A results in Rheumatoid Arthritis by yearend.
For LX1032, we will be moving onto the expansion phase of the U.S. study and we anticipate our Phase 2A results in the first quarter of 2011.
For LX1031, as I described, we’re completing our formulation work for LX1031 and at the same time, we’re moving along LX1033, and we’ll be lending our Phase 1 trial of that compound in the first half of 2011 using the biomarker information to define our best agent for moving forward in IBS. And finally for LX4211, we will be getting our results of our PK/PD mechanistic study by yearend and we’ll be reporting out the next study in the early 2011 with commencement of the Phase 2B study anticipated in the second quarter of 2011.
With that update, I’ll now turn it over to Jeff Wade.
Jeff Wade
Thank you, Brian. I will provide a brief financial update.
As indicated in our press release today, we had revenues from the 2010 third quarter of $0.8 million, a decrease of 63% from $2.1 million for the prior year period. The decrease was primarily due to reduced revenues under our alliances with Taconic Farms and Bristol-Myers Squibb.
For the nine months ended September 30th, 2010, our revenues decreased 61% to $3 million from $9 million for the prior year period. Our research and development expenses for the 2010 third quarter increased slightly by 4% to $20.1 million from $19.3 million for prior year period.
With the nine months ended September 30th, 2010, our R&D expenses decreased slightly by 2% to $61.4 million from $62.4 million for the prior year period. Our general and administrative expenses for the 2010 third quarter were $4.9 million, an increase of 8% from $4.6 million for the prior year period, primarily attributable to higher salaries and benefit.
For the nine months ended September 30th, 2010, our G&A expenses increased 4% to $15.5 million from $15 million for the prior year period. Our net loss for the three months ended September 30th, 2010, was $27.5 million of $0.08 per share compared to a net loss of $19.1 million or $0.14 per share in the prior year period.
Net loss for the nine months ended September 30th, 2010, was $78.8 million or $0.27 per share, compared to a net loss of $60.8 million or $0.44 per share for the prior year period. For the three and nine months ended September 30th, 2010, net loss included non-cash stock-based compensation expense of $1.3 million and $4 million respectively.
For the three and nine months ended September 30th, 2009, that net loss included non-cash of stock-based compensation expense of $1.3 million and $4.1 million respectively. Let me turn to our cash and investments.
As of September 30th, 2010, we had $231 million in cash and investments as compared to $255.8 million of net cash and investments as of June 30th, 2010, and $125.1 million as of December 31, 2009. Now, let’s turn to our forward looking financial guidance for 2010.
We are on track to achieve our yearend guidance. Our contractual revenues from existing agreements for 2010 should be in the range of $4 million to 5 million as we have previously discussed.
As we have previously communicated while we are in conversations with pharmaceutical companies about potential collaborations or alliances, we have not included forecasted revenues from those potential arrangements in our guidance. We do believe that our protected pipeline will provide Lexicon with attractive opportunities for future alliances.
We expect operating expenses for 2010 to be in the range of $100 to 105 million, which is narrowed from our previous guidance of $100 to 110 million. Non-cash expenses will be approximately $10 million of this total and including $5 million in stock-based compensation and $5 million in depreciation and amortization.
Taking into account cash received under existing contractual relationships only, we expect our 2010 net cash yield operations to be in the range of $85 to $90 million, which is down from our previous guidance of $90 to 95 million. Finally, as we discussed in our last earnings call, we exercised a restructured purchase option under our drug development financing collaboration with Symphony Icon Holdings and acquired all the equity of the Symphony Icon, Inc., thereby reacquiring all rights to LX1031, 1032 and 1033 and the other direct programs subject to the collaboration.
As part of this commitment, we and Symphony agreed to revise terms under which we paid Symphony Icon Holdings $10 million cash payment upon closing and agreed to make certain additional deferred and contingent payments. We acquired the $4.4 million of cash held by Symphony Icon at the time of acquisition, so our net cash outflow for the acquisition during the quarter was $5.6 million.
The total of the upfront payment and all deferred and contingent payments will not exceed the $90 million exercised price applicable under the terms in the purchase option that were in effect before the restructured agreements were signed. Importantly, this arrangement increases Lexicon’s financial flexibility in that the deferred payment and the contingent payments may be paid in cash, common stock or combination of cash and common stock in our discretion provided that at least 50% of any payment made on or prior to July 30th, 2012 will be paid in common stock and no more than 50% of any payment made after that date will be paid in common stock.
We will be accounting for the Symphony Icon acquisition as business combination, which will involve recording the fair value of the assets acquired along with the fair value of the associate liabilities on our balance sheet. I will now turn the call back to Arthur.
Arthur Sands
Thank you, Jeff. We can now take questions.
Question-and-Answer Session
Operator
(Operator instructions). Your first question comes from the line of Cory Kasimov with JP Morgan.
Matthew Lowe – JP Morgan
Hi, there. It’s actually for Matt Lower in for Cory today.
Just a couple of things. Firstly, just wondering if you could just update us on your thoughts from the potential tying of partnership for 4211 and you may be thinking the four, the stuff for the Phase 2B trial once the study is underway or perhaps waiting until you have the Phase 2B data, and then I have a quick follow-up.
Jeff Wade
So, while we are continuing to talk to potential partners on this program, we are proceeding with plans to initiate the Phase 2B study. And based on the unique dual mechanism inhibition of SGLT1 and SGLT2 and the additional mechanistic data, we have a great deal of confidence that we can build on that Phase 2A data especially as it relates to HgA1c, which is the primary end point for diabetes trial.
So, we think it believes that this program warrants that we do what’s necessary to maximize the value for this program which will involve progressing along with the planned program as well as considering potential partnership discussions along the way.
Matthew Lowe – JP Morgan
Okay. And then my follow-up question is just for the bridging work for 4211.
Will you, in January, when we hear about the results of that study, will you be prepared to talk about the [inaudible] findings at that time or will we need to wait for that?
Brian Zambrowicz
I think one of the things we’re trying to do is continue to build on the differentiation in mechanism. So, not only as I mentioned we’re measuring GLP-1.
But this time, we’ll be measuring both total and active GLP-1. Also, one of the things what we’re doing in the study is we included a high glycemic index diet and we’re tracking post-prandial glucose control and glucagons as well as insulin.
So, this can allow us to again obtain additional mechanistic data because GLP-1 effect would be expected to improve post-prandial and post-senile [ph] glucose control.
Arthur Sands
So, we are currently planning to report on that in January.
Matthew Lowe – JP Morgan
Okay. That’s great, thank you.
Operator
Your next question comes from the line of Phil Nadeau with Cowen & Company.
Phil Nadeau – Cowen & Co.
Good morning. Thanks for taking my questions.
My first question is on LX1032. I’m sorry if you mentioned this in your prepared remarks, I missed it.
But after you get the data from both the U.S. and European Phase 2 studies; is the plan to still move right into a pivotal trial?
Brian Zambrowicz
Yes, Phil, that is the plan. So that will require, of course, a discussion with the FDA and European authorities.
But that was what we outlined at our pre-IND meeting with them and we’re going to foresee it along those lines.
Phil Nadeau – Cowen & Co.
Thank you.
Brian Zambrowicz
And I think actually the discussion could take place really after we have the results of the U.S. trial, at least in the United States.
We’re very [inaudible] asked about that opportunity. By the way, we had a good interaction with investigators at the recent North American Neuroendocrine Tumor Society Meeting or NANETS in the United States and there, we did we highlight both trials for investigators and since the – I’d say good investigator enthusiasm for the mechanism on the compound.
Phil Nadeau – Cowen & Co.
And what has to happen now in the beginning of enrollment of the expansion cohort. Is it something [ph] that has to happen or is it just kind of logistic details.
Brian Zambrowicz
It’s really logistical at this point. We have completed the enrollment on the dose escalation cohort, the last one and we started aligning patients for the expansion phase.
Arthur Sands
And one of the nice things is that we have set ourselves up with long-term talks, so that we – we’re pretty well setup to be able to move in to those type of studies.
Phil Nadeau – Cowen & Co.
Okay, great. Thanks for taking my questions.
Brian Zambrowicz
Sure.
Operator
Your next question comes from the line of Steven Willy with Stifel Nicolaus.
David [ph] – Stifel Nicolaus
Hi. This is David.
My question, just wondering on the 1033 front with respect to the follow-on IBS, how much of that is related to excitement around this improved potency and how much of it is related to maybe some reformulation challenges on the current molecule side.
Brian Zambrowicz
I’ll comment on that. I think we all want to necessarily put all our eggs in one basket so to speak.
So that in case our formulation changes are not sufficient, we think that 1033 gives us the clear additional potential compound. But it’s just on a physical chemical properties and potency to give us the improvements that we’re looking for.
David [ph] – Stifel Nicolaus
Good. And you’re thinking about maybe how this program moves forward with respect to business development perspective, is it safe to assume that probably 1033 and 1031 are attached to hit now?
Brian Zambrowicz
Yes. I think it’s safe to say that both being locally acting agents in the gastrointestinal tract that that’s likely, will likely the case.
David [ph] – Stifel Nicolaus
And then …
Brian Zambrowicz
And I think – go ahead.
David [ph] – Stifel Nicolaus
I’m sorry, go ahead.
Brian Zambrowicz
I was just going to say I think we’re really eager to identify the right candidate for moving forward because there has been a high level of enthusiasm for the mechanism as well as for the fact that we have this objective biomarker for the first time in the indication.
David [ph] – Stifel Nicolaus
And any giving thoughts just to how large a pivotal Carcinoid trial may need to be and maybe just give in some of the challenges around patient enrollment right now. How do you think about internally trying to drum up, I guess, some of the interest around the compound?
You obviously said that you were at a medical conference recently and kind of highlight in the program to investigate. But is that something that you plan to really focus on here in the coming year?
Arthur Sands
Yes, absolutely. There’s a high interest level in the compound among investigators.
And it being really the first new small molecule to enter the scene that is directly on mechanism for this tumor type both in terms of symptom control and potentially growth. So, in terms – the first part of your question and terribly half of the conversation with the FDA, we really can’t say, but our guess would be under a 100 as the ballpark.
So, this is not a large study that would be required. Of course, again, it’s dependent on the discussion with the FDA and the ultimate determination of what kind of end points we ultimately go after, et cetera and the timing.
Brian Zambrowicz
I was just going to the same thing as far as size. You can look at other physical trials for Carcinoid agents, even studies for on tumor progression and then a small 89 patient, some of that is going to spend exactly what the FDA or EMEA desire to see.
One of the things that I would hope is if and when we get the results of our study, if their positive, they’ll be a lot more incentive for patients to get into the trial because they know they’ll be a getting a benefit. The other thing I’d say is that there may be even more clarity to the need to deal with some of the symptom issues based on the recent Evorolimus data, where Novartis demonstrated an ant-tumor benefit and if these patients are living longer, they’re just going to continue to have to deal with the side effects.
In addition, the cardio vascular problems are going to become even more as after data and that’s directly where our agents hits.
David [ph] – Stifel Nicolaus
And then just one more question on 2931. You talked about RA being a pretty good surrogate of efficacy and other autoimmune disorders.
Can you maybe talk about what other syndications you’re contemplating now and whether or not you would choose to maybe keep those in-house, if you decide to out license the RA program?
Arthur Sands
Well, there’s several. Inflammatory Bowel Disease and Crohn’s Disease is one we’re looking at closely, number one.
We’ve also discuss Psoriasis in the past, where that is typically been an indication that is seen as another important surrogate for other applications later applications, which could also include transplantation. So, now that’s sort of in order, not necessarily in order of difficulty.
Transplantation is probably the most difficult. So, those are something that we have actually developed summary [ph] plans around.
I think we’re eager to see the results and then decide how to foresee it. Another very rational approach based on results would be just to [inaudible] and totally focus on that and of course; this is part of them that has garnered high partnership interest as a small molecule in RA.
So, we have – I think we’ll have a lot of options on the table, of course, that’s all pending the results.
David [ph] – Stifel Nicolaus
Great, thanks.
Arthur Sands
Thank you.
Operator
(Operator instructions). There are no further questions at this time.
Arthur Sands
Well, I’d like to thank everyone for participating given the number of important upcoming program milestones which Brian summarized. I’m sure that we will be updating you on several of these between now and the next conference call.
So, again, thank you for participating. Bye bye.
Operator
This concludes today’s conference call. You may now disconnect.
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