Rigel Pharmaceuticals, Inc. (RIGL) Q3 2017 Earnings Report, Transcript and Summary

Good afternoon, and welcome to Rigel Pharmaceutical's Financial Conference Call for the Third Quarter of 2017. All participants are in a listen-only mode. We will be facilitating a question-and-answer session at the end of today's conference [Operator Instructions]. I would like to remind you that this call is being recorded for replay purposes at Rigel's Web site [Operator Instructions]. And now, I would like to turn this conference call over to our first speaker, Dolly Vance, who is Rigel's Executive Vice President, Corporate Affairs and General Counsel.

Welcome to our financial results and business update conference call. The financial press release for the third quarter of 2017 was issued a short while ago and can be viewed in the News & Events section of our Investor Relations page of our website, www.rigel.com. Joining me on the call today from Rigel are Raul Rodriguez, our CEO; Ryan Maynard, our CFO; Anne-Marie Duliege, our Chief Medical Officer; and Eldon Mayer, our Chief Commercial Officer. As a reminder, during today's call, we may make forward-looking statements regarding our financial outlook and our plans and timing for regulatory and product development. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. A description of these risks can be found in our most recent quarterly report in Form 10-Q on file with the SEC. Any forward-looking statements are made only as of today's date, and we undertake no obligation to update these forward-looking statements to reflect subsequent events or circumstances. At this time, I would like to turn the call over to our CEO, Raul Rodriguez.

Thank you, Dolly. And welcome everyone. Thank you for your time this afternoon. This past quarter has been an exciting one as we worked to potentially bring our new therapeutic option to adult patients with chronic immune thrombocytopenia or ITP. During this call, we will recap our most recent achievements including our interactions with the FDA, discuss highlights of clinical data, discuss our commercial efforts to-date as well as give you an update on our financial position. Collectively these activities demonstrate why we are so positive about what you expect from Rigel in the next six to 12 months. On slide 8, a few years ago we made a substantial change to Rigel’s strategy to transition to a commercial stage company. This strategy was based on fostamatinib as an excellent foundation for this pivot. We conducted market research, had discussions with KOLs and ITP to establish the medical need, had discussions with the FDA on approval path and then planned our commercial efforts. We are now delivering on that strategy. We conducted a Phase 3 program in ITP and announced results late last year. We filed the US NDA for fostamatinib in ITP in April and it was accepted in June. We are now managing that NDA towards an approval and Anne-Marie will give us an update on this effort. We are also planning on commercializing fostamatinib in the U.S., Eldon will provide some background and an update on those activities. Our therapeutic areas of focus are immunology, hematology, oncology disorders and rare diseases. Immunology has a foundational expertise at Rigel. We use our understanding of the immune system and apply it to various therapeutic areas. And finally, we move various program via partnerships, an example fostamatinib in North American territories where we will put partnerships in place. On slide 9, here’s why we are so excited about the fostamatinib opportunity. The indications we are pursuing are attractive orphan indications with an efficient patient populations to make an impact that’s still addressable by a focused company. Each of these indications have significant unmet medical needs and are treated by products with limitations. In the case of IgA nephropathy or autoimmune hemolytic anemia, nothing has been approved. In ITP, only the TPO agents are approved and they have limitations according to KOLs and to patients with ITP. So why my fostamatinib contributed in various. First, it has a unique mechanism of action that my address the underlying autoimmune basis of these autoimmune diseases. This is different than any of the currently available agents. Second, we have shown an important patient benefit in ITP, in our Phase 3 studies our trials showed timely, a robust and an enduring benefit and platelet responses. Today, we will introduce to an additional measure of clinical benefit that is a clinically relevant platelet response. This clinically relevant platelet response was 43% in our studies. Anne-Marie will discuss this in a few minutes. In autoimmune hemolytic anemia, we have shown a 35% response rate in hemoglobin improvement in our Phase 2 study. In IgA nephropathy we have shown the trend towards improvement in proteinuria and an acceptable safety profile in the lower dose cohort of this trial. We hope to show even better results with the higher dose of fostamatinib in the second cohort which fully enrolled last quarter. Finally, we are excited about fostamatinib’s large safety database. We have a 5,000 patient year safety database in several autoimmune diseases with the observed adverse events being similar across these. This is the largest propulsive paradigm for addressing each of the most frequent adverse events while still allowing patients to continue to benefit from fostamatinib. The safety experience also helps tremendously in our regulatory discussions. On slide 10, a quick review of our four key accomplishments for this quarter. In September we had a teleconference with the FDA for our Mid-Cycle Communications Meeting which is a standard meeting built into the FDA’s review process. At that time the FDA confirmed that they were not planning to schedule an oncology drug advisory committee or ODAC meeting to publicly review our NDA submission. They also confirmed that they except to complete their review by April 17 of 2018 which is the date supplied by the FDA under the Prescription Drug User Fee Act also known as PDUFA. Anne-Marie will give us further details on these interactions as well as our regulatory plans in Europe. In October we announced top-line results from our stage 1 of our Phase 2 study of fostamatinib with the treatment of patients with one antibody autoimmune hemolytic anemia or AIHA. Stage 1 of the study which included 17 patients showed a response rate of 35% and met the pre-specified primary efficacy endpoint. In light of these results, we will begin enrolling stage two of the study which will have an identical study design and include 20 additional patients. We will also pursue discussions with the regulatory -- on the regulatory approval for the product in autoimmune hemolytic anemia. We also completed very successful fund-raise in October, which sets us up very well for executing on our plans. Ryan will give us further information on this. And finally, on launch preparations. We have made substantial progress in understanding the ITP opportunity as well as hiring the commercial organization to commercialize fostamatinib. However, Eldon will provide some insights into this in his presentation. So with that, let's try typewriting. Anne-Marie?

Thank you, Raul. As always I want to thank my colleagues for their ongoing hard work and dedication in support of our NDA submission. It has been very gratifying that we have been able to responsive the FDA’s questions. We will continue to work closely with the agency and remain hopeful that providing FDA approval we'll be able to bring this few drugs to a patient population with unmet treatment needs. As we've noted before, the NDA included data from our fifth preclinical program, two pivotal studies 047 and 048 as well as a continuing long term open label extension study 049. Overall, patients who responded fostamatinib had a timely robust and sustained response to treatments. The fifty preclinical programs confirm that fostamatinib has a consistent and predictable safety profile alignment with a large safety database. As shown on Slide 12, Rigel focused on fostamatinib through chronic ITP because there was a significant unmet medical need. There are approximately 65,000 patients with chronic ITP in the U.S. and it qualified as an orphan disease. ITP is a rare autoimmune condition. ITP arises from various disease mechanisms of platelet destruction and in some cases insufficient platelet production. The pathophysiology of ITP is complex and many factors that contribute to the disease may differ from patient to patient making this a clinically heterogeneous disease. This disease is characterized by an increase risk of bleeding often with -- bleeding. However at times at results such as GI or brain hemorrhage can be more senior and possibly cells. Treatment options exist but they’re limited after with side effects and the response can vein over time. There is no treatment that specifically prevents platelet destruction. Sick time is the key figure in the immune system destruction of ITP. That’s why fostamatinib and stick inhibitor with the unique mechanisms of actions it's a particular interest. Moving to Slide 13 you can see that there were two similar Phase 3 trials followed by an open-label extension. -- was allowed at week four and patients with no response had the option to switch to the long term extension study as of week twelve. Slide 14 provides the main base sign characteristics of patients in the Phase 3 program. This is a patient station population typical of ITP, middle aged female patients, but these are patients with the senior form of ITP. As shown by the median duration of ITP prior to study entry of 8.5 years but some patients had decades of ITP disease prior to entry. Multiple prior ITP treatment and finally very low platelet count at baseline with a median of 16,000. I now want to review with you how we are evaluating efficacy in this disease as shown on Slide 15. First, the stable response rate is defined in the protocol which has at least four out of six biweekly platelet counts greater than 50,000 per micro liter in absence of rescue medication during weeks 14 to 24. This was agreed upon with the FDA and corresponds to the high bar in terms of platelet count. In further analysis we looked at the ASH guidelines which highlight the importance of maintaining platelet counts greater than 30,000. Hence in collaboration with our advisors KUP leaders we investigated a more overall clinically relevant response. We looked at patients with a platelet count during the first 12 weeks of treatment of greater than 50,000 per microliter in the absence of rescue medication and the duration of response is defined by not dropping below 30,000 at two consecutive visits. We call this a clinically relevant platelet response. The response was consistent between the two randomized controlled studies and the open label extension study. On Slide 16 on the left panel is the primary efficacy end point from study 047 and 048. The treatment effect is a stable response of 18%. On the right panel we now see that the response rate of patients who cross from placebo to fostamatinib in study 049 is 23% similar to that observed in studies 047 and 048. Slide 17 reminds us that responses on fostamatinib are durable. 82% of the stable responders maintained response for at least one year and response duration of more than two years have now been observed. The key point is that the platelets' response is long lasting, in fact the medium duration of response has now been reached and is as of now exceeds this 28 months. Looking at the serious adverse events of bleeding on Slide 18 in the two people trials we've seen how the response, that this response is clinically relevant. Indeed there were no such serious adverse events of bleeding among the stable responders during the control portion of the study as compared to the non-responders and the placebo patients. Now we move on to Slide 19, the most recent post doc analysis that we have completed for the ICP-12, as mentioned earlier this analysis looks at the overall clinical benefit and the potential clinical utility of fostamatinib in ICP which may have direct bearing on the commercial potential. I will remind you that choosing our defined clinically relevant platelet response as stated on Slide 15 and again here on Slide 19 we found that 43% of the fostamatinib treated subject and 14% of the placebo treated subjects met this criteria. The median duration of response for fostamatinib patients was greater than 28 months using the April 2017 data cut off submitted to the FDA for the 120 day safety object. Slide 20 shows a median platelet count over time for patients who had a fostamatinib clinically relevant response in green versus the fostamatinib non-responders in blue and the placebo patients in orange. The immediately response for the 43 subjects -- with a vigorous response showing was robust and enduring compared to the non-respondents and the placebo patients. On slide 21 you can see that 60% of the quickly responders do so within two weeks and 80% within eight weeks. This is important because doctors treated with fostamatinib patients will know quite rapidly whether the patients find benefit from fostamatinib or not, and certainly why we discuss. As a reminder, on the next line, I just would like to do a quick review of the adverse events for the pivotal trial. You see that most of the adverse events were mild or moderate. And they were mostly conceived adverse events in the placebo group compared to the fostamatinib treatment. This is because the bleeding events were less frequent in the fostamatinib ARM. The most frequent adverse events observed were diarrhea, hypertension and [synthetic] enzyme elevation. So in conclusion of our summary of the fostamatinib program in ITP, the type of the clinical data across ITP and a larger message of slightly database support a favorable beneficiary profile for patients exposed to fostamatinib. In responder ITP patients treatment with fostamatinib result in higher outcome, fewer bleeding events and manageable safety implications. For non responding patients any safety events are evenly manageable in routine people practice and the risk is immediate to a duration of up to 12 weeks. If approved by the FDA fostamatinib may be an important introduction by blocking disruption and generating the clinically relevant response in patients with chronic or persistent ITP. Slide 24 shows a quick overview of the U.S. regulatory interactions to-date. The open designation was granted in August 2015. We submitted an NDA earlier this year and this NDA was accepted for review by the FDA. We are also provided a 120 day safety update. The Mid-Cycle Communication, during this Mid-Cycle Communication we have reconfirmed that no advisory committee meeting was planned and overall there was no showstopper in our interaction and our responses to questions from the FDA. And finally we expect the PDUFA date by -- of April 2018 which remains unchanged. In addition we had one special triazole and two clinical starts which went well. In regards to filing with the European authorities on slide 25, we believe that we have data that also merits the submission of the marketing authorization application or MAA to the EMEA. We have requested National Scientist Advice Meeting in Spain, the UK and the Netherlands and a meeting date has been set up with the UK. This concludes my ITP review, and I will now move on to discuss our autoimmune hemolytic anemia program. Autoimmune hemolytic anemia or AIHA is due to the presence of warm antibodies that react with protein antigen on the surface of red blood cells above temperature. The disruption of red blood cells leads to reduce oxygen generally to the issue resulting in fatigue and dyspnea when exercising. In some patients the symptoms can be more severe with dyspnea addressed and varying degrees of fatigue. In rare cases of the most severe anemia the critical syndrome may become less threatening. It is an ultra rare disease with approximately 40,000 adult patients in the US. Similarities of treatment used with ITP exists with steroid, rituximab, other monoclonal agents and splenectomy beign available but in fact there are new medical treatment that are specifically approved for autoimmune hemolytic anemia. So there are similar reasons to study in autoimmune hemolytic anemia. One, the unique mechanism of action which addresses occur of autoimmune hemolytic anemia. The clear treatment effect in ITP is an indicator of the value of second addition to treat autoimmune disease such as hemolytic anemia. This is still an objective in cone to change the hemoglobin. And finally we benefit again from this large safety database of more than 5,000 patients years primarily in RA and ITP. Slide 21 -- 27 summarizes the design and the results so far. The design of the study is -- obviously two study is an open-label two-stage study. The primary endpoint is the response rate in the first 12 weeks without the need for rescue therapy. And the response defined as a hemoglobin of at least 10 gram per deciliter and at least 2 gram per deciliter increase from baseline. On the top-line 12 week basis the Phase 2 achieved a pre-specified primary efficacy endpoint for stage 1. The patient population on slide 28 is also characteristics of the general patient population with autoimmune hemolytic anemia, mostly middle age women and of course they had a low hemoglobin as sign of the anemia. On slide 29 we will review the hemoglobin response in stage 1 of this trial. 17 patients had at least one baseline hemoglobin measurement. We observed a response rate of 35% six out of 17 on fostamatinib. Four patients responded during the 12 week evaluation period and on the preliminary basis an additional two patients met the response criteria in the extension study after 12 weeks of dosing. Two of the 17 patients withdrew early from the study due to non-safety related reasons and will be replaced for study protocol. For the verification and the comprehensive analysis of the patients data will continue and will be presented in the near future. In terms of safety profile on slide three, there was no new adverse events in the program. Three patients with serious adverse events all assessed had no treatment related by the investigator. One patient recovered and continued on treatment, two patients had serious adverse events resulting in fatalities in both cases these patients were [indiscernible] due to [indiscernible] and in one of them also due to CLM. One patient had skin necrosis with infection and another patient an elderly gentleman had pneumonia. So in summary on Slide 31 six out of 17 patients approximately 25% of patients had a response to subjects which respond during the extension period of the study. There was no new safety signal and no drug related serious adverse events. Two patients dropped out and will be replaced through protocol and we've achieved the primary endpoint successfully. In terms of next step we're now planning to enroll in stage 2 of the trial of an additional 20 patients total. The orphan drug designation application is in progress and we're working on our regulatory strategy to define an optimal path to approval. Now would like to pass you to Eldon for a look at commercial activity, Eldon.

Thank you, Anne-Marie. Today I'd like to review several aspects of our launch preparation and in particular some details on how we view the adult chronic ITP market. As Raul mentioned this is part of our company's transition from pure research and development to bringing at first product to market. In our many initiatives thus far our commercial team has spent a significant amount of time making sure we have a good understanding of the ITP market, consider our approach to commercialization is correct I'd like to share a few of those insights with you. In addition I'd like to describe the commercial team we've been building to support the launch as well as some key activities we've been working on to prepare to enter the market. What I'll cover at a future time are some more specific topics such as pricing and market access. First I'd like to review the ITP patient landscape according to our analysis. On this Slide you can see there're approximately 65,000 adult patients with chronic ITP in the US which of course qualifies it as an orphan disease, and in a given year approximately 50% of these patients or 32,500 are estimated to be actively treated but it's important to keep in mind that if these patients are followed for a longer period of time the proportion of them that are treated would increase significantly. For the remaining half of the 65,000 patients we estimate that 23% of those or 15,100 are treated with steroids during the year, the remaining 27% of those patients or 17,400 are steroid refractory and receive any of the current available treatment such as rituximab, [indiscernible] agents, splenectomy etc, and this represents the addressable market for fostamatinib. As part of our market analysis we analyze the claims records of approximately 6,000 adult chronic ITP patients over a five year period and we're able to see how most ITP patients typically progress through the various lines of therapy, this is shown on Slide 35. As a general comment it’s important to note that because the chronic ITP population is a heterogeneous disease it's difficult for a clinician to predict which patient might respond to a given treatment if any. And therefore, many different therapies are used and the sequencing of treatment is highly variable. So given all of that it’s actually not surprising how fragmented this market actually is and that no single treatment dominates any one therapy. It’s also important to understand that patients frequent cycle on and off of various available treatments and in addition steroids are frequently used concurrently with all of these treatments, although this kind of steroid uses is not shown on the slide. Moving on to the next slide, another important area we’ve learned about is a result of our analysis and market research thus far with the unmet treatment need that exists for this market. First, we were able to confirm that among most physicians treating ITP the primary pathogenesis of adult chronic ITP is thought to be immune system play the destruction as Anne-Marie mentioned. And yet this disease pathway is not specifically addressed by any currently available treatment. Additionally, there are a number of other areas that physicians have expressed that unmet need including a high rate of additional treatment utilized after splenectomy and rituximab, a high rate of fluctuation in platelet levels that exist over the course of currently available treatment and some safety concerns that exist with these treatments. Over the course of our preparation for launch -- excuse me, our course of preparation for the launch goes well beyond market analysis. Our commercial team has been very busy with launch preparation and on this slide you can see just a few examples of our key initiatives. I am pleased to say that we are well on track to being ready for launch in Q2 of next year. And lastly on slide 38 you will see an overview of the structure of the commercial team that’s been building. I am pleased to report that we have been successful with identifying and hiring a team with extensive industry and launch experience in both rare diseases and in large markets, and in small as well as large companies. We plan to build a seasoned sales team with a strong background in hematology, oncology and oral oncolytics, and we’ve already hired all of our key leadership including a National Sales Director. We are very excited about the opportunities to bring fostamatinib to market which we believe can make a difference in lots of patients with ITP that need other treatment options over what is currently available. And I am confident that with Rigel management and this team we will be able to do that successfully. Now, I will turn the call over to Ryan for a financial update.

Thank you, Eldon. The successful financing that we completed last month has put us in a good financial position. The 65.3 million that we actually received from the stock offering basically doubled our cash position and allowed us to extend our run rate comfortably into 2019 including the potential launch cost for fostamatinib. Any upfront amounts received from successfully partnering outrights to fostamatinib in Europe or Asia would add to this run rate. It’s important to note that during this calendar year we have already invested over 8 million in launch preparation cost. This amount is expected to ramp in ‘18 as we look to a potential commercial in the second quarter of 2018. Now, on some of our financial results from Q3. We reported revenues from collaboration of 900,000 in the third quarter of 2017 which related to a payment received from a license agreement with a third-party. Revenues from collaborations of 3.8 million in the third quarter of 2016 represented the remaining amortization of the upfront received from Bristol-Myers Squibb. We reported to costs and expenses of 18.8 million in the third quarter of 2017 compared to 26.5 million for the same period in 2016, this decrease in cost and expenses was the result of the reduction in workforce undertaken at September of '16 and the completion of the pivotal Phase 3 clinical trials on ITP. Now this decrease was partially offset by the increase in costs related to the preparation for the potential launch of fostamatinib in ITP that I just mentioned earlier. As a final note I'd like to point out that the Rigel finance organization has been very focused on building the appropriate system and infrastructure including people to support the potential launch of fostamatinib. The team is very excited to support this phase in our transformation. Back to you Raul.

Thank you very much Ryan. Needless to say this progress is very exciting at Rigel, our team has accomplished significant milestones this year in executing on our strategy and this being the final call, financial call of the year let me recap some of those. We filed our first NDA as a company for fostamatinib in ITP. We managed the regulatory interactions with the FDA successfully. We demonstrated a broader clinical utility to fostamatinib in hemolytic anemia and we made substantial progress in preparing for the product launch next year, and thanks to you we have the capital to accomplish this. In all it's been a excellent year for Rigel. We are confident that we will continue to make substantial progress on our strategy in the coming year and it should be even more monumental. So with that I'll turn it over to, call over to questions.

Thank you [Operator Instructions]. Our first question comes from Eun Yang from Jefferies.

Question on fostmatinib in autoimmune hemolytic anemia. So you are moving into say into extension court, are you expecting to start the Phase 2 trial with additional 20 patients by end of this year.

Thank you, Eun. There maybe one or two patients that may come off before the end of the year depending on what's happening at the end of the existing cycles that occurs interim role in the trial, but more importantly in order to involve the majority of patients in cohort two we will open new sites and that will start next year.

I see, do you think you need this additional 20 patients from stage two in order to maybe the FDA to talk about to discuss [indiscernible].

No, we intend to go and talk to the FDA once we have completed stage one and looked at all the data in detail.

Okay, that would be first quarter next year?

First half of next year but possibly [indiscernible] first half of next year.

And then also you submitted a [indiscernible] or abstract for ASH on this data, so if it's not accepted then would you provide us with the data by year end?

I think I’ll give this as well. I think our plan would be to publish that at another presentation perhaps the EHA meeting in Europe or another venue where we would have a broad audience like that.

But you will find that setted by November 22nd, correct?

That’s correct. And we do have an oral presentation on the ITP data at ASH. So we will inform and the rest of our -- the community in terms of if we do have leg breaker or not.

Okay. The last question is on the partnership for first line ITP for the US. I think on the last call you mentioned that perhaps the progress on the NDA in the US may be important particularly a deal for a substantial amount of money. So should we expect any kind of partnership that still to be expected for the PDUFA date?

I think the U.S. approval would be an important milestone just in terms of validation and in de-risking for an ex-US partnership, partnerships, plural. And so I think that’s an important step. We would like and we are engaging with companies already ahead of that so that they are well prepared to go into deeper discussions after that PDUFA date. We are hopefully closing something not that part to the future beyond that. But it’s an important step as you can imagine.

Your next question is from Anupam Rama with JP Morgan. Your line is open.

Thanks for taking our question. This is [Casa] filling in for Anupam this evening. Given that fostamatinib represents a novel mechanism of action for the treatment of ITP in a sense addressing a disease from the opposite side to TPOs but how should we be thinking about the potential for a combination use? Do you have any plans to study fosta in combination use?

Our most important objective was to establish the role of fostamatinib in itself as a potential treatment for patient. Down the road we extend that physicians might be interested in looking at this combination even on a case-by-case basis for some of their patients, or potentially as part of an investing responsive trials. We have not defined that yet but we are not excluding that for the future. It will make sense from a mechanistic perspective but it was important to us to understand, establish and clear the role of fostamatinib on its own prior to being potentially as part of the combination.

Our next question comes from Do Kim from BMO Capital. Your line is open.

Hi, thanks for taking my question. This is Alex on for Do. Wanted to know a little bit more color around label negotiation with the FDA and what you think the chances are around label for fostamatinib?

Yes, so we are going to initiate our discussion with the FDA shortly on label negotiation. We are asking for broad label which is justified by the circle with approval we’re defined where patients with Phase 1 treatment without specifying which treatment or the number of previously treatment before and this is what we have requested. So we will see. At this point, the FDA has not given an indication otherwise, but it will be too early to say that.

And with the new clinically relevant platelet response most of the physicians they talk to, how do they view this end point with respect to other endpoints that we've seen, stable response and intermittent response.

They certainly value it as more clinically relevant endpoint, as I indicated during the presentation the stable response rate is the one defined by the FDA as high bar and similar to what has been used to approve [indiscernible]. But based on the guidelines and based most importantly on the clinical experience of the physicians we do not need to see consistently platelet counts of 50,000 rather an increase in platelet count to 30,000 and above and most importantly a reduction in bleeding episodes is what matters for physicians and of course for the patients as well.

Thanks and just one more question to how variable is the time to response from patient to patient that you see in ITP and also the similar time to response that you see in AIHA patients.

As indicated the response is pretty rated, 60% of the responders will respond within two weeks. Approximately 80% of the responders within eight weeks, and the totality of the responders by week 12. And we seem to see approximately the same rate in autoimmune hemolytic anemia although two additional responders responded after 12 weeks.

Thanks for taking my questions and congrats on the progress.

Our next question is from Joe Pantginis from H.C. Wainwright, your line is open.

I following up obviously you said you're about to begin your label negotiations besides that can you maybe give a little punch list about what might be outstanding, for example are there any facility inspections that still need to occur.

So just to be clear we don't know when the label, we don't have a clear sense of the label negotiations that is our next upcoming step that is obviously scheduled prior to our [indiscernible].

And any additional things that might be required like facilities?

Well, it's a very good question we have not had any facility inspections at yet, that might be required or sometimes I'm told they're not required so it's a bit variable in that sense.

And then just wanted to go back to AIHA for a second, do you have any more color with regards to the timelines of enrolling the second stage.

Not really, we're working on this we're waiting to open new sites and actually new countries and we will have a better idea of what to anticipate by early next year.

Great, thanks a lot.

Thank you, Joe.

I now would like to turn the call back over to Mr. Raul Rodriguez for closing remarks.

Well thank you for your time, we appreciate your questions and your interest, it's been a very exciting year at Rigel. We will continue to give you regular updates on the regulatory and commercial milestones and on our pipeline. And as always thank you for your support we greatly appreciate it. Good afternoon.

Ladies and gentlemen thank you for participating in today's conference, this does conclude the program, you may all disconnect.