Albireo Pharma, Inc.
Q2 2018 Earnings Call Transcript

Published: 7 Aug 2018

[Operator:]

Good morning, ladies and gentlemen, and thank you for joining us for Albireo's Conference Call to provide a Business Update for the First-Half of 2018. Following some prepared remarks from the company, we'll open the call for questions. I would now like to turn the call over to Paul Arndt from LifeSci Advisors, representing Investor Relations for the company. Please go ahead, sir.

[Paul Arndt:]

Thank you, Operator, and good morning everyone. Thank you for joining today's call during which management will provide an update on Albireo's performance in the first-half of 2018. Earlier today, Albireo issued a press release highlighting recent business accomplishments and noting its financial results for the second quarter and six-month period ended June 30, 2018. The press release is accessible via the company's Web site at www.albireopharma.com. Before proceeding, let me mention that comments today may include forward-looking statements made under the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements other than statements of historical fact regarding the plans for or progress, scope, cost, duration or results of, development of A4250, elobixibat, A3384, or any other Albireo product candidate or program, including prevalent data, target indications for development, size, design, population, location, conduct, objective, duration, endpoints, timing for initiation or completion of, or for reporting the results from, or regulatory feedback regarding any clinical trial, including Albireo's planned Phase 3 trial of A4250 in patients with PFIC, the commercial outlook for any Albireo product candidate or program or opportunity in any target indication, and any additional payment that HealthCare Royalty Partners or EA Pharma may make to Albireo, the period for which Albireo's cash resources will be sufficient to fund its operating requirements, or Albireo's plans, expectations or future operations, financial position, revenues, costs or expenses. Actual results may differ materially from those expressed or implied by any forward-looking statement as a result of many factors including those described under the heading Forward-Looking Statements in the Albireo's press release from earlier today, or under the heading Risk Factors in its most recent Form 10-K or in later fillings with the SEC. Albireo cautions you not to place undue reliance on any forward-looking statement. Also, any forward-looking statement that is made speaks only as of today, Tuesday, August 7, 2018 and should not be relied upon as representing Albireo's views as of any future date. Albireo disclaims any obligation to update any forward-looking statement, except as required by applicable law. With that, I'll turn the call over to Ron Cooper, Albireo's President and Chief Executive Officer. Ron?

[Ron Cooper:]

Thank you, Paul, and thank you everybody for joining today's conference call. With me today is Tom Shea, Albireo's Chief Financial Officer; and Jan Mattsson, Albireo's Chief Operating Officer and one of our Co-Founders. I'm really curious [ph] and excited that we've made significant progress at Albireo in Q2 by, one, advancing development of our lead asset A4250 for serious rare pediatric liver diseases; two, strengthening our regulatory and patent position across our assets; three, preparing for the commercialization of A4250; and four, striking the organization with key appointments. Now, let me go into greater detail on each of these items, and we'll be happy to expand further with your questions on these topics. Advancing A4250, Albireo achieved a significant milestone in the second quarter by enrolling the first patient in PEDFIC-1, our Phase 3 clinical trial progressive familial intrahepatic cholestasis or PFIC. Now for those of you who are new to the A4250 story here's a quick synopsis. The Phase 3 program includes a single randomized double-blind placebo-controlled multicenter clinical trial designed to enroll approximately 60 patients with PFIC type 1 or type 2, and an open label extension study to assess long-term safety and durability of response. The placebo-controlled trial will evaluate two doses of A4250 for 24 weeks. The primary endpoint for the FDA evaluation and a key secondary endpoint for the EMA is a change in pruritus using a proprietary tool we developed. The trial's primary endpoint for the EMA and a key secondary endpoint for the FDA is serum bile acid responder rate. Our team continues to work expeditiously to activate all of the clinical trial sites around the world following very well attended investigators meeting in the U.S. and in Europe. And now we're on track for site activation with 12 sites activated in the U.S. and Europe at the end of July. As we previously guided, we continue to expect data to be available around the end of 2019 or early 2020, and we plan to refine that guidance as we get closer. Now, in addition, we released data at scientific congresses that strengthen the support for the developing efficacy profile for A4250. Provided key insights on the negative impact pediatric liver diseases have on quality of life that were used in the creation of our patient-reported outcomes and observer-reported outcomes tools for the Phase 3 trial, and evaluate the utility of certain biomarkers in predicting both early and long-term outcomes of PFIC patients. On the regulatory and patent front, we participated in a PRIority MEdicines or PRIME kickoff meeting at the European Medicines Agency that included our rapporteur. PRIME provides enhanced dialogue with the EMA to accelerate assessment of priority medicines. In June, we announced that the FDA granted rate pediatric disease designation to A4250 for PFIC. This designation affirms our eligibility to apply for a priority review voucher upon submission of an NDA. A priority review voucher is a valuable asset that can be redeemed to obtain priority review for another molecule or maybe sold or transferred for another subsequent marketing application. I'm very pleased to announce that, in June, the company was granted a method of use patent for elobixibat for the treatment of NASH in both the U.S. and Europe. We'd previously disclosed that we were confident in obtaining this patent and is one of the gating items for initiating our Phase 2 study in NASH. We are reiterating our guidance that we anticipate initiating this trial in the first-half of 2019. Now that we have the A4250 PEDFIC-1 study up and going, and we need to now begin writing this for the potential regulatory filings for approval and commercialization. For the filings, overall preparations are on track, including manufacturing preparations and long-term safety and toxicology studies. For commercialization, we started the early part of the buildup having appointed ahead of marketing and initiated deployment of medical science liaisons. We also conducted research to gain deeper insights in the size of the patient population for cholestatic liver diseases, the patient journey, physician reaction to A4250, and potential price comparators. We wanted to take this opportunity today to share a couple of pieces of high-level insight we've been gathering related to the opportunity in rare cholestatic liver disease and PFIC. In the first-half of the year, we completed early market research encompassing qualitative and quantitative studies with physicians who treat PFIC and parents of children with PFIC in the United States and Europe, along with an additional market scoping study with U.S. physicians and secondary research on pricing analogues. The results of this research contribute to our emerging view of cholestatic liver disease population size, the level of interest in A4250, and a better assessment of the overall opportunity. Unfortunately there's a paucity of literature on the prevalence of pediatric cholestatic liver disease, and we're not aware of any patient registries. As a result, we have modeled the size of the patient population using available literature, secondary resources, and recently completed market research. We look at the potential opportunity for an agent to treat cholestatic liver disease in three areas, pediatric liver disease, adult liver diseases, and other diseases that may cause cholestasis such as cystic fibrosis and in others. While we see a tremendous opportunity for A4250 in many diseases, we've chosen to focus the development of A4250 on pediatric cholestatic liver diseases. Our initial prevalence estimate had a range of about 30,000 to 50,000 cholestatic liver patients, and we continue to refine our understanding of the prevalence. And based on the incidence data and our primary and secondary market research on agent survival, we've narrowed this range now to 30,000 to 40,000 for cholestatic liver diseases that are of primary interest to us initially as investigational targets, including PFIC, BRIC, biliary atresia, Alagille, and PSC [ph]. We've adjusted our mix for the different diseases with PFIC together with BRIC in the same range, biliary atresia lager, and Alagille smaller. Based on this research we estimate that there are 8,000 to 10,000 PFIC and benign recurrent intrahepatic cholestasis or BRIC patients in the U.S. and E.U. Most experts would suggest the term benign is really a misnomer. BRIC patients have the same genetic defect as PFIC, and manifest the same symptoms, particularly severe episodic pruritus. We estimate the average survival for PFIC patients is about 15 years, whereas for BRIC patients it's about double that. As you're aware, our Phase 3 trial is only enrolling patients with PFIC types 1 and 2. We believe A4250 ultimately could prove useful in other rare cholestatic diseases including biliary atresia, Alagille syndrome, and primary sclerosing cholangitis. And we're assessing these areas, exploring clinical development, and generation of data to potentially address these diseases. Having precise estimates of these population will continue to remain a challenge, but the insight we're gradually developing gives us confidence in our market outlook. So before I hand the call over to Tom to discuss the financials, and let me close with an update on key appointments to really strengthen our organization. We're building an outstanding organization, and in the first-half of the year we've been pleased to welcome Anne Klibanski and Stephanie Okey to our Board of Directors. Anne is currently a professor medicine at Harvard Medical School, Chief Academic Officer at Partners HealthCare, and academic dean for Partners HealthCare at Harvard Medical School. And Stephanie is the former Senior Vice President and Head of North America Rare Diseases for Genzyme. Both additions bring deeper insights into orphan diseases and commercialization to our board. I'm also pleased with the addition of Jason Duncan as our General Counsel. We recently announced that Paresh Soni stepped down as our Chief Medical Officer and has been succeeded by Patrick Horn as our new Chief Medical Officer. I want to take the opportunity to thank Paresh for all his hard work, and the important contributions over the past years where he's been integral in the design, regulatory process, and initiation of the PEDFIC-1 trial, but immensely delighted that he will stay on as an important consultant to the company. I'm very excited to welcome Pat as his pediatric background and real deep Phase 3(2) approval regulatory experience will be instrumental as we enter this next stage of growth of the company. Okay, I'll now hand the call over to Tom for a quick financial update. Tom?

[Tom Shea:]

Thanks, Ron. Let me quickly highlight our financial results for three and six months ending June 30, 2018, which we released earlier today. We closed the second quarter ended June 30, 2018 with a balance of $183.2 million in cash and cash equivalents compared to $53.2 million at December 31, 2017. Our revenue for the second quarter of 2018 was $730,000 and $11.9 million for the six months ended June 30, 2018. Our research and development expenses for the second quarter of 2018 was $6.4 million compared to $3 million in the second quarter of 2017. R&D expenses for the six months ended June 30, 2018 were $12.6 million compared to $5.8 million in the same period of 2017. Our G&A expenses for the second quarter of 2018 was $4.2 million compared to $3.7 million in the second quarter of 2017. G&A expenses for the six months ended June 30, 2018 were $8.4 million compared to $6.9 million in the same six-month period of 2017. Net loss for the second quarter ended June 30, 2018 was $14.6 million or $0.22 per share compared to a net loss of $6.2 million or $0.86 per sharein the second quarter of 2017. Net loss for the six months ended June 30, 2018 was $16.2 million or $0.42 per share compared to a net loss of $12.8 million or $0.91 per share in the same six-month period of 2017. Based on our current operating plans, we anticipate our operating expenses in 2018 to be in the range of $45 million to $50 million with the expected increase over 2017 driven primarily by the execution of a global Phase 3 clinical study of A4250. From a cash standpoint, we expect our current resources will be sufficient to meet our operating requirements into 2021 under our current plan. Our guidance for upcoming important events have not changed with planned initiation of trials of elobixibat and NASH, A3384 and BAM and a second indication for A4250 all in 2019. Top line data from our PFIC Phase 3 trial is expected at the end of 2019 or early 2020. And finally, we reflect a conclusion in the Russell 2000 Index as part of the annual reconstitution of the Russell stock indexes. And with that let me turn the call back over to Ron for some concluding remarks.

[Ron Cooper:]

Great. Thank you, Tom. So to summarize, we remain tremendously excited to be advancing the PFIC I Phase 3 trial and bringing hope for potential new therapy to people with PFIC and their families. That is our core focus right now, along with advancing our broader pipeline. At the same time we continue to present data that add to our understanding of PFIC, and we'll continue to strengthen our understanding of the market. Okay. So with that we'll open the call up to questions. Operator?

[Operator:]

Thank you. At this time we will conduct a question-and-answer session. [Operator Instructions] Our first question comes from Eun Yang with Jefferies. Please proceed with your question.

[Eun Yang:]

Thank you. So Ron, since you have done some pre-commercial activities, based on the size of the market and a number of targeted acquisitions [ph], how many sales reps do you think you would need to build?

[Ron Cooper:]

Yes, good morning, Eun, thanks for the question. I think one of the things that we started to do with our market research is actually just to scope out the size of the target audience. And if you look, from a target audience perspective in the U.S., probably there are around 100 A targets and then another 1,200, B, C, D targets. So highly concentrated, and also highly concentrated in the tertiary centers. So we're starting to now think about both Europe and the U.S. on how we would deploy. We think we're probably going to deploy somewhere between 15 to 20 field deployed individuals. And the reason I use the term field deployed, I think we're still looking at is there a way that we can be innovative in our model and really target effectively, but that's the range of what we're thinking about.

[Eun Yang:]

So 15 to 20 are the ones that -- in the U.S. and then approximately same number in Europe?

[Ron Cooper:]

Yes, approximately, about the same. So that's the way we think about it, it's a similar amount in Europe.

[Eun Yang:]

Okay. And then you mentioned the 30,000 to 50,000 patients with cholestatic liver disease, that only refers to the pediatric patients, correct?

[Ron Cooper:]

So, a couple of corrections in that, so we've been guiding previously a range of about 30,000 to 50,000 patients at a wider range. And that range comes from mostly literature and secondary sources. We've been able to do some pretty interesting market research and that's helped us refine -- so that's why we've tightened that to about 30,000 to 40,000. And we've also changed the footprint to just U.S. and Europe in this case. So the rest of the world, because it's so difficult to get all that data, we haven't really looked at Japan, Canada, Latin America and Asia. So then the number that we have for 30,000 to 40,000 takes us with both the adults and the pediatric population at a given time.

[Eun Yang:]

Okay, great, thank you.

[Ron Cooper:]

Hopefully, that clarifies?

[Eun Yang:]

Yes, thanks. And then one question to Tom, so you mentioned that the operating expenses for the year to be about $45 million to $50 million, but I think in Ron's remark, there are about [indiscernible] activated at the end of July and then you expect to activate the remaining, you know, like 20 to 30 sites by end of this or the next year. So you don't really expect uptick in R&D expenses for the second-half of this year?

[Tom Shea:]

No, Eun, it's going to be spread pretty evenly over the quarters, because there are a lot of startup expenses associated with getting the trial up and running, and then you have the ongoing expense, once we start to actively recruit the subject. So as it worked out, it's going to be fairly evenly spread over the quarters. So we do anticipate coming in at $45 million or so range.

[Eun Yang:]

Great, thank you very much.

[Tom Shea:]

You're welcome.

[Operator:]

Our next question comes from Katherine Xu with William Blair. Please proceed with your question.

[Katherine Xu:]

Yes, good morning. I was just wondering whether Ron, you, could give some -- just frame the 12 sites opened by the end of July, is that ahead of expectations, on track, and what is sort of the next step of expectations? And in general, maybe give us some color on the sentiments at the sites around the study, that would be really helpful.

[Ron Cooper:]

Yes, good morning, Katherine, and thanks for the question. I think, to start with, the excitement with our [indiscernible] and the sites is really unbelievable. They've been waiting for us to get up and going, the cooperation that we've enjoyed with the study investigators and their site has been excellent. I've been receiving a fair number of notes from some of those investigators and they're just relieved that we're up and going. So they're cooperating with us. Now that being said, this is a study that we anticipate having somewhere between 35 to 45 sites, so it will be in over 15 countries. And the protocol itself is a well-written protocol, but it is a complicated protocol, because it touches a lot of every institution, right, everything from the clinical parts to the pharmacy, to -- you know, we take blood, we have imaging. So as we try and get approvals in each of those sites, it's a fair chunk of work. So then to characterize where we are, you know, the 12 sites that we have up and going is actually pretty much on track of what we're expecting. We are working hard right now to get sites up as quickly as possible. And that is the focus of the coming months, working with those sites, because they want to get the patients in. But we've got to work our way through those IRBs, the contract process and some of the other things to get going.

[Katherine Xu:]

Thanks. And then with regard to the NASH program, what have you learned incrementally over the past quarter about the potential of [indiscernible] indication and maybe just give us some more information on that?

[Ron Cooper:]

Well, thanks for the question, Katherine. I think one of the first things; I think we are -- earlier in the year that we had said that the NASH development program was gated against the patent, all right. So let me talk about that and then maybe I'll hand it over to Jan to talk a little bit about what we are excited about from a NASH perspective. So we were waiting on a method of use patent. We had said that we didn't believe that it was going to be rate limiting for the start [ph] and we were pretty confident about that. So we announced in this quarter that in fact, we did achieve the receipt of that patent. So we're delighted about that and we're on track. Jan, maybe you want to talk a little bit about where we are with the NASH program?

[Jan Mattson:]

Sure, sure. So just to say that what we had learned last half year as you may know there's been a tremendous movement in the bile acid field in action and not more -- recently from Sanyal's group, for example, showing that bile acid are increased in patients with NAFL to NASH. So we are confident as before we have clinical data which is little better, showing us we're lowering cholesterol. We increased COB 1 and we affect our doses in the inflammation, as you know key of our markets of NASH. And so we are engaged with KOLs and are starting to guess the protocol for our studies. So that's where we are and [indiscernible] as we said, guiding for us to first-half next year.

[Ron Cooper:]

So we're on track.

[Katherine Xu:]

Okay. And lastly, I'm just wondering the general kind of thought on the clinical development plan of the labor extension assuming that PFIC 1 is successful. Do you think some single-arm studies would work or do you think every single population, [indiscernible] et cetera, you have to do a PFIC 1 trial kind of AC study?

[Ron Cooper:]

Yes, good question, Katherine. We don't know exactly to be honest. I think that the number one thing is that we're committed to generating data across multiple cholestatic liver diseases. We are in very heavy discussions right now with our advisory group of key opinion leaders on particular study designs. And I think what we'll do is once we get that feedback, we'll sit down with the agency as well and get their feedback. But my guess would be it will probably be some combination of those types of things, because we'll want to provide as much data as possible for prescribing physicians and for patients that really understand the true potential of this product.

[Katherine Xu:]

Thank you very much.

[Ron Cooper:]

Thanks, Katherine.

[Operator:]

Our next question comes from Yasmeen Rahimi with ROTH Capital. Please proceed with your question.

[Yasmeen Rahimi:]

Hi, team. Ron, a question for you, can you elaborate a little bit more in terms of the market research in relationship to some of the pricing comparisons that you have done and then where can we find this information, while this sort of -- this market [indiscernible] has been disclosed in one of your recent slide decks? And then I have a follow-up question.

[Ron Cooper:]

All right. Thank you, Yasmeen. So in terms of market research, earlier we had done very little amounts of market research. And so we've gone pretty heavy in the first part of this year. So we've done full qualitative market research, we've done quantitative market research and which has given us some insight on the patient journey. We've done some more secondary research, and we've done some pricing benchmark research. And I think that what we've said previously given that PFIC was a ultra-orphan disease, that it's ultra rare. That has a symptomatic relief, but -- we hope to demonstrate a long-term benefit as well. The range for those products are somewhere between $300,000 and $600,000 a year because of that high-end medical need. Now, one of the things that we've done, Yasmeen, is our corporate presentation has changed a lot over the last year, because there are a lot of things moving at the same time. But we recently updated our corporate presentation and you and others can find that on our website in the investors section if you click to the bottom right and there's more information there.

[Yasmeen Rahimi:]

Thank you, Ron. And then can you elaborate a little bit more, last week Shire made the announcement that they're discontinuing their 626 study in NASH. And with that in mind, can you maybe remind us again of the IC50 of elobixibat versus 626, and maybe some insight that you have why they decided to discontinue that trial?

[Ron Cooper:]

Okay, well, thanks very much, Yasmeen. I think that this is a sort of step back. Jan and others in our scientific team have been working in bile acids for well over 20 years now. And listen, let me make a few comments and then I'll ask Jan to sort of add a bit more. So I think we have a pretty good understanding of IBAT inhibitors. And even our two IBAT inhibitors, elobixibat and A4250 are different compounds. They're both IBAT inhibitors but they're different compounds. They act differently, and that's why we specifically have tried to put the right IBAT inhibitor in the right disease and at the right dose with the right patient population, so, that's why we're pretty confident about what we're doing and how we're fitting the right agent for the right disease. Jan, maybe you want to add a little bit of why we're excited about…

[Jan Mattsson:]

Sure. As you said, we are really confident on the rationale for elobixibat in NASH. And elobixibat, it's very potent, highly selective, and locally acting drug. Now, comparing to SHP626, we have times ten more potent compound, about. But I think, as we have discussed before, we have clinical data with elobixibat showing the lowering, increase in GLP 1, we have a lot of preclinical data showing the effects on the inflammation on fibrosis. And as I said before, I think the field of bile acids are moving very heavily, and I think the data showing that the [indiscernible] of NASH is associated with the increased [indiscernible] of the bile acids is really important. So I think we're confident.

[Ron Cooper:]

Thank you, Jan.

[Yasmeen Rahimi:]

Thank you, Jan. One last question, with The Liver Meeting upcoming, have you guys submitted any abstracts in relation to some of the work that you guys are doing in regards to the validation of the pruritus measure?

[Ron Cooper:]

So in the fall there are really two meetings in the U.S., there's AASLD and [indiscernible]. We have made some submissions to both of those meetings. Plus, there are some of the other independent groups that are putting together content as well. So as we get closer to that we'll let you know.

[Yasmeen Rahimi:]

Thank you for taking my questions.

[Operator:]

Our next question comes from Alan Carr with Needham & Company. Please proceed with your question.

[Alan Carr:]

Hi, thanks for taking my questions. I wanted you to clarify a bit around prevalence of PFIC patients. And previously you had said maybe around 8,000, 3,000 in the U.S., 5,000 in Europe or so. And I'm wondering if that's changed substantially. I think you bundled it with BRIC, and wondered if you could breakout your newest prevalence estimate of PFIC. And then also I think you touched on some of the parallel non-clinical work that's going on in the side in parallel to your Phase 3 work. Can you elaborate a bit more on that, what's going on in that area? Thanks.

[Ron Cooper:]

Thanks, Alan. Good morning, thanks for your question. Maybe just taking the second one first, it's a quick answer to that. As you do a filing you have some standard things that you need to have in place. And some of those standard preclinical studies, such as your cancer stock study and your repo talk studies need to be in place. And they take time to do, right, they are long-term studies. And so just wanted to let you all know that in fact those are all up and going. They're proceeding as planned, and they should not be gating items for our filing. So it sort of indicates our overall package of thinking about we're starting to move our thinking towards not just PEDFIC-1, the Phase 3 study, but how we ensure that when we do that data we're able to do a strong filing, and then translate that over to effective commercialization of the product. Then as to your questions about prevalence in regards to PFIC, I think, as I said in my prepared comment, for the longest time we've been using the literature as secondary resources. And that's the best that's there. Obviously, we will prefer if there was published literature on the prevalence or that there were registries, but there are not. We have been able to strengthen our thinking with some primary market research that makes a big difference particularly getting insights on the survival curve. And that has had us adjust the overall picture of what we believe from prevalence perspective. So at the top end where we have guided somewhere 30,000 to 50,000, we've narrowed that a little bit to 30,000 to 40,000 as we have gotten more insights on the total cholestatic liver disease population. And then, as it relates to PFIC, we've previously given guidance around 8000 to 10,000 that was our estimate. But now -- but now we have given -- now our guidance to similar 8000 to 10,000. But in getting greater insights, the mix within that 8000 to 10,000 is different. So, think about it roughly about half of that is PFIC and half of that is BRIC. Now this reminds you what is BRIC, what is the same part of BRIC and is different parts of BRIC versus PFIC. So on the same category, the same genes that occur in PFIC is also the same clinical manifestation most of the time. These kids get very severe pleuritis and often are treated in the similar manner of as PFIC patients. Probably the biggest difference though is the disease itself in terms of it's episodic. So, BRIC patients tend to have at least on average one episode a year or more. It lasts about five months. So it's intermittent. So as a result of the difference -- the other difference is in estimated survival. PFIC children we estimate right now with current treatment is around 50 years. And for BRIC, it's about 30. So then -- then getting back to sort of to summarize the numbers. So think about the 8000 to 10,000 about half PFIC and BRIC. And then think about the U.S. and Europe is pretty much the same; half in the U.S., half in Europe based on our recent physician research.

[Alan Carr:]

Okay. Thanks for talking my questions.

[Ron Cooper:]

Thanks, Alan.

[Operator:]

[Operator Instructions] Our next question comes from Liana Moussatos with Wedbush Securities. Please proceed with your question.

[Liana Moussatos:]

Congratulations on your progress and for taking my question. I am wondering about the design of Phase 2 for elobixibat and NASH. What are you thinking about for primary endpoint?

[Ron Cooper:]

Thank you for the question, and thank you for the comments, Liana. So we are still working on that. It's not finalized as yet. But I think -- think about the study as more as a strong proof-of-concept for this mechanism leaning towards a PDFF [ph] type of endpoint. But that hasn't been finalized yet. Right now we are in the process of spending time with our key opinion leaders really to refine that. I don't know if you want to add any…

[Jan Mattsson:]

I think that's right. I mean we are in very good discussions with the [indiscernible] and we'll -- I guess I will guide on this later.

[Ron Cooper:]

Yes, I think our plan later on, Liana, is to kind of once we have locked down with the key opinion leaders and we are comfortable with the regulators, somewhere later on we will kind of walk through the whole program for you.

[Liana Moussatos:]

Okay. Thank you very much.

[Operator:]

Thank you. At this time, I would like to turn the call back over to Ron Cooper for closing remark.

[Ron Cooper:]

All right, Operator, thank you very much. First of all, thanks everybody for tuning in. I think that we made a lot of progress in this last quarter. So, wishing you all, you know, all the best for the end of a terrific summer. Bye-bye.

[Operator:]

Thank you, ladies and gentlemen. This does conclude today's conference. You may disconnect your lines at this time, and have a great day.