Arrowhead Pharmaceuticals - Earnings Call - Q2 2015

Transcript

Speaker 0

Ladies and gentlemen, welcome to the Arrowhead Research Fiscal twenty fifteen Second Quarter Financial Results Conference Call. Throughout today's recorded presentation, all participants will be in a listen only mode. After the presentation, there will be an opportunity to ask questions. I will now hand the conference call over to Vincent Anzalone, Vice President of Investor Relations for Arrowhead. Please go ahead, Vince.

Speaker 1

Thank you. Good afternoon, everyone, and thank you for joining us today to discuss Arrowhead's results for its fiscal twenty fifteen second quarter ended March 3135. With us today from management are President and CEO, Doctor. Christopher Anz alone Chief Operating Officer and Head of R and D, Doctor. Bruce Gibbon and Chief Financial Officer, Ken Myszkowski.

Management will provide a brief overview of the quarter and will then open up the call to your questions. Before we begin, I would like to remind you that comments comments made during today's call may contain certain forward looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements other than statements of historical fact, including without limitation, those with respect to Arrowhead's goals, plans and strategies are forward looking statements. Include, but are not limited to statements regarding anticipated safety and or efficacy of ARK-five twenty, ARK AAT, ARK F12 and our other programs as well as anticipated timing for study enrollment and completion and the potential for regulatory and commercial success. They represent management's management's current expectations and are inherently uncertain.

Thus, actual results may differ materially. Arrowhead undertakes no duty to update any of the forward looking statements discussed on today's call. You should refer to the discussions under Risk Factors in Arrowhead's Annual Report on Form 10 ks and the company's quarterly reports on Form 10 Q for additional matters to be considered in this regard. With that said, I'd like to turn the call over to Doctor. Christopher Anzalone, President and CEO of the company.

Chris?

Speaker 2

Thanks, Vince. Good afternoon everyone and thank you for joining us today. In a view of the previous quarter and period since our last call, we are very pleased with the progress we've made on several fronts. I will cover a few of the highlights now and then turn the call over to Bruce Given, our Chief Operating Officer and Head of R and D to discuss our clinical programs in more detail. During the quarter, we acquired Novartis' entire RNAi business.

This portfolio of assets represents almost a decade of work by Novartis and gives us some important new capabilities. Portfolio includes multiple patent families covering RNAi trigger design rules and modifications that we believe fall outside of key patents controlled by competitors. Combined with the chemistry portfolio constructed by Roche, we feel that we can work on any target and indication. In addition, Novartis discovered novel intercellular targeting ligands that can enhance the activity of some RNAi triggers by targeting the RNA induced silencing complex or risk more effectively and improving stability once risk is loaded. Think of these as sophisticated RNAi activity enhancers.

Also included was assignment of Novartis' license from Alnylam Pharmaceuticals granting Arrowhead access to Alnylam intellectual property excluding delivery IP for 30 gene targets already chosen by Novartis. And lastly, a pipeline of three candidates that were in active development and went through the rigorous Novartis vetting process. View this acquisition then as the addition of new tools to our already substantial RNAi toolbox and this feeds into our broad two pronged philosophy. First, we want to have the freedom to address any target and indication from an IP standpoint. Second, we want to have access to as many RNAi trigger structures and modifications as possible in order to tune each candidate and employ the optimum chemistries on a candidate by candidate basis.

When these two frameworks are substantially in place, a company shifts from developing the candidate it can make to developing the best possible drug patients. That is where I believe we are and the Novartis acquisition contributes to this. We've already been working to integrate these assets into our development operation and in fact we are currently testing the Novartis chemistries to determine if they should be used in our most advanced preclinical programs. Our research and early development groups have also made some important advancements in DPC technology We published a paper describing our next generation DPC constructs that use proprietary masking chemistries with increased stability and longer circulation times. These constructs have the added benefits of allowing conjugation of the RNAi triggered directly to the DPC.

All of these changes are designed to enable both subcutaneous administration and extrahepatic delivery, which would dramatically expand the universe of diseases that may be addressed by DPC enabled RNAi therapeutics. Last week, we also presented preclinical data at the TIDES conference on ARKF12, our potential new drug candidate targeting Factor XII mediated diseases such as hereditary angioedema and thrombosis. The studies we presented demonstrated that ARKF12 achieved deep dose dependent and durable knockdown of the target gene in rodent and primate studies. In multiple dose primate studies with IV administration, once every four weeks approximately 90% knockdown was achieved after the first dose and even greater knockdown following subsequent doses. In a relevant mouse model of thromboembolism, ARKF12 showed a dramatic increase in occlusion times and appeared to protect against thrombus formation or clotting.

ARKF12 appeared to be generally well tolerated and no drug related changes in toxicity markers were observed in these animal studies. We are in the process of conducting studies in additional models for hereditary angioedema or HAE to provide further data to decide if we will advance ARKF12 as a clinical candidate and initiate IND enabling studies. Patients with a rare genetic disorder HAE can experience recurrent and dangerous acute inflammatory attacks in multiple tissues with attacks of laryngeal edema being particularly serious and potentially fatal. Currently approved prophylactic treatments targeted toward HAE involve frequent intravenous dosing of one to 3x weekly and many patients do not respond adequately. So we believe there is a great opportunity to develop an improved therapeutic that may only require dosing every four or six weeks.

Turning to our clinical programs. In February of this year, we began dosing ARC AAT, our clinical candidate for the treatment of liver disease associated with alpha-one antitrypsin deficiency or AATD. We announced last week that we had completed the healthy volunteer portion or Part A of the study and that we had been cleared by the Data Safety Committee to transition the study into Part B, which will be conducted in patients with AATD. This transition was triggered when a predefined knockdown target was achieved in Cohort three of the study. AAT is an endogenous gene, so healthy volunteers with AAT without AATD produce functional AAT that can be easily measured with a simple blood draw.

These early results suggest that in humans we can knock down endogenous genes expressed in the liver. We have always been confident that this would be the case, but now we have clinical data to support it. This is very exciting and I believe another important validation for our underlying technology platform that may have far reaching implications as we continue to expand our pipeline. The planning and execution of the study by our clinical development team has been outstanding to date and they are now working to get the patient portion of the study moving forward. We also made good progress in the clinical program for ARK-five twenty, our candidate against chronic hepatitis B infection.

We had productive discussions with the FDA on our plans for a multi dose study and received some valuable feedback about the program that has been incorporated into our plans for The U. S. As well as Europe and Asia. In April, we gained clearance from the FDA to proceed with the HEPARC-two thousand and four clinical study with an initial dose of one mg per kg. We are pleased to be moving forward with that study here in The U.

S. And expect that it will generate valuable data about ARK520's activity in a multi dose setting. Thus our multiple dose Phase 2b studies remain on track and we expect to begin dosing patients in The U. S. This quarter.

We also believe that we may begin receiving approvals international studies this quarter with dosing likely beginning in the summer. As we've said in the past, we are true pioneers in HBV. Everything we learn in clinical and non clinical studies help shape our strategy for the indication and much of what we are doing represents first for the field. Of course, is extremely helpful to us, but it also introduces real questions relating to communication strategy in light of competitive considerations. We have been fairly quiet about the program since presenting early data at AASLD, which I might add was notable because only single initial doses of ARK-five twenty elicited what we believe to be the first reliable report of significant S antigen reduction humans.

This relatively quiet period does not mean that we were idle. To the contrary, we have been very busy and have learned a tremendous amount about ARK520 and hepatitis B virus. Here's what we are prepared to disclose at this time. For the first time we can report that we have been conducting a long term study of ARK-five twenty in nine chimpanzees chronically infected with hepatitis B. It has been going on for about a year completion.

We believe this to be the largest and longest study ever conducted in chronically infected chimpanzees and certainly the most exhaustive study to date with ARK-five twenty. We have generated a large amount of very exciting data and we are not yet finished. I believe this study will advance the entire field of HBV and it has been very important in advancing our understanding of how ARK-five twenty may fit into a treatment strategy. The wealth of data, the CHIMP study and the single dose Phase 2a study have provided very important insights into the drug and disease some of which challenge current dogma. To date we have not spoken publicly about any of this CHIMP data.

These studies have led to new hypotheses and we decided to test some of these new hypotheses in humans by adding three cohorts to the Phase 2a study in Hong Kong, which remains blinded. None of these employ doses greater than four mgs per kg and two are open label while the third is a double blind placebo controlled cohort. These are important groups and we are very excited about completing them. We have said repeatedly in the past that this program would be iterative in nature and that we would follow the data. This is an example of flexible stance.

Unfortunately, because of the new cohorts because one of the new cohorts is placebo controlled, this will mean pushing back unblinding of the entire study to next quarter rather than this quarter. I appreciate that some will be disappointed that we are changing guidance for release of the three and four mg per kg results from second to third quarter, but we did not anticipate expanding the Hong Kong study when we set that guidance. Our regulatory team and advisers agreed that unblinding the study once all the blinded cohorts have run their course is the prudent course of action under these circumstances to maintain the integrity of the studies in the eyes of the scientific community and the international regulatory authorities. It is simply unwise and frankly uncommon in the pharmaceutical industry to unblind cohort by cohort without a compelling reason to do so, such as our decision to unblind the first two cohorts in preparation of an FDA filing. I strongly believe that our long term Chimp study will be considered seminal HBV work and it has enabled us to build a more complete Phase IIa study in humans.

This is all great news for the field and for the company. So a one quarter delay in data release is a small price to pay when we are focused on creating durable long term value. We will have a tremendous amount of data to report between the seven cohorts of patients in the enlarged Phase 2a and a greater than one year study of nine chronically infected chimps. Because of the quantity and importance of these data, we will have an Analyst Day next quarter to present the findings in detail. We plan on having not only our scientists participate, but also internationally recognized experts in the field.

It will be an important event for us and I also believe it will be an important event for the entire HBV field. With that overview, I would now like to turn the call over to our COO and Head of Development, Doctor. Bruce Gibbon. Bruce?

Speaker 3

Thank you, Chris, and good afternoon, everyone. As you heard from Chris, our clinical development and regulatory teams have recently and are doing a great work designing and managing our clinical studies. Chris touched on this, but I would like to talk for a moment about the HEPARC-two thousand and one study of ARK-five twenty. As you recall, this was a single dose Phase 2a study in e antigen negative chronic HBV patients at two sites in Hong Kong. We previously reported initial results from the first two dose cohorts at one and two mgs per kg.

And as of our last quarterly conference call, we had enrolled an additional two dose cohorts at three and four mgs per kg. Observation periods are complete for these and the cohorts remain blinded. We have since made protocol amendments to add three additional cohorts, two of which have received IRB approval to proceed and we expect the third to be approved as early as this month. We have already enrolled and dosed seven of eight patients in the first new cohort and hope to dose the last patient shortly. The second additional cohort is recruiting patients now.

Similarly, we expect the third new cohort to enroll at a good pace once IRB approval is achieved. As you know, we unblinded the one and two mgkg cohorts last year in order to support an IND and other regulatory filings for multiple dose Phase 2b studies. We expect to unblind the entire Phase 2a study, which will include the three and four mgs per kg cohorts as well as the additional blinded cohort next quarter. We understand that many of you would like us to disclose data from the three and four mg per kg cohorts now and we would also like to be able to discuss those. However, unblinding cohorts while other blinded cohorts are still running should only be done under limited circumstances such as for an FDA filing.

This is a marathon not a sprint and we need to ensure the long term integrity of the program and the studies that may ultimately support regulatory approval. We are committed to following GCP standards and regulatory norms in order to ensure as smoother regulatory process as possible. As Chris mentioned, we have already generated a great deal of information in the long term Chimp study and the now expanded Phase 2a that we believe will prove important for the HBV field. Once we are able to unblind the entire Phase 2a next quarter, we will have an in-depth Analyst Day to discuss these data alongside the long term Chimp data. We expect to host internationally recognized KOLs as part of this event.

Given the scope of the data, we believe that several important presentations articles will emerge from these studies in addition to what is reported at the Analyst Day. This will be an exciting time for us, so stay tuned. Turning to the multiple dose Phase 2b studies of ARK-five twenty, we received clearance from the FDA to proceed with the HepARC2004 study in The U. S. This is a randomized double blind placebo controlled multi dose study of ARK-five twenty administered intravenously to patients with chronic immune active HBV infection maintained on entecavir or tenofovir.

The study is planned to enroll up to eight patients who will be randomized at a ratio of two to one with eight patients receiving one mg per kg of ARK520 and four receiving placebo. Each patient will receive three total doses once every four weeks. Patients will be followed through day 147. The primary objective of 2,000 the depth of hepatitis B surface antigen decline in response to multiple doses of ARK-five twenty compared to placebo. We intend to open three sites for enrollment.

One site was opened for enrollment last week and patient screening has begun. Site initiation for the other two is scheduled for the coming weeks after which they may begin recruiting and screening patients. As we have mentioned before, we still intend to proceed with additional international multi dose trials. We have incorporated the FDA recommendations, which were constructed and cost bearing to the program overall into our international regulatory findings, which have been submitted during the last couple of months. We are working diligently with regulators in select European and Asian countries now and we intend to provide an update publicly after we have been cleared to proceed.

We have also made great progress in a very short amount of time on our second clinical candidate, Arc AAT against liver disease associated with alpha-one antitrypsin deficiency, which we shorthand as AATD. In just over two months, we initiated a Phase one study completed enrollment and dosing of three ascending dose cohorts in healthy volunteers, collected follow-up data, surpassed predefined knockdown targets and have received Data Safety Committee approval and transition into patients with AATD. I want to applaud our clinical operations team for great execution and a successful start to this groundbreaking study. We plan to conduct Part B of the study, which will recruit patients with PIZZ genotype AATD in Australia and potentially other geographies. The site in Australia is on schedule to gain ethics approval to begin recruiting of alpha-one patients in the next week or so and we hope to add three to five additional sites going forward.

The protocol for Part B is essentially the same as Part A. It's a placebo controlled double blind single dose escalation study to evaluate the safety, tolerability and pharmacokinetics of ARK AT and the effect on circulating alpha-one antitrypsin levels in patients with the disease. The study plans to enroll in dose cohorts of six participants each with participants randomized in a ratio of two to one active to placebo to receive a single intravenous injection of either RKAT or placebo. Dosing in patients with AATD will begin at two point zero mg per kg of UNA and one point zero mg per kg DPC, which was the highest dose used in Part A and then dose escalation will proceed according to the protocol. The study evaluates participants for twenty eight days following dosing with additional follow-up if needed every two weeks until AAT levels return to baseline.

We hope to complete the Phase one study by the end of twenty fifteen. While I have presented a healthy amount of work for our clinical team, we are also starting to design the Phase two multiple dose study of ARK AAT and some of the Phase 2b combination studies of ARK-five twenty. So stay tuned for more details about our plans later this year. With that, I'd like to turn the call over to Ken Myszkowski, Arrowhead's Chief Financial Officer. Ken?

Thanks, Bruce, and

Speaker 4

good afternoon, everyone. As we reported today, our net loss for the three months ended March 3135 was $28,700,000 or $0.51 per share based on 55,700,000.0 weighted average shares outstanding. This compares with a net loss of $14,000,000 or $0.31 per share based on 44,300,000.0 weighted average shares outstanding for the three months ended March 3134. Net cash used in operating activities during the second fiscal quarter were $16,400,000 compared with $7,700,000 in the prior year period and $24,200,000 in the first fiscal quarter. Cash used in operating activities during the quarter of $16,400,000 were primarily composed of research and development costs, mostly program costs for ARK-five 20 and program costs for ARK AAT, as well as R and D salary and wages and related discovery research costs.

Total operating expenses expenses for the three months ended March 3135 were $29,700,000 compared with $11,300,000 for the three months ended March 3134. The increase in operating expenses compared to the year ago period are heavily influenced by a non cash charge of $10,100,000 for acquired in process research and development costs, a component of the accounting related to the Novartis acquisition. Additionally, there were higher research and development expenses, primarily drug manufacturing costs, which increased $3,200,000 during the period, mostly related to ARK-five twenty as well as higher clinical costs, which increased $1,200,000 Clinical costs have increased as we incur start up costs from our CRO related to the planned ARK-five 20 Phase 2b studies. We also incurred costs for our second clinical candidate ARK AAT of about $2,900,000 while ARK AAT clinical trial costs in the comparable period were minimal. The primary drivers of the change in cash used in operating activities as compared to fiscal twenty fourteen is consistent with the drivers of the change in operating expenses aside from the $10,100,000 acquired in process R and D cost.

The consideration provided for the acquisition of the Novartis assets was cash and stock. Dollars 25,000,000 of stock was issued during the fiscal period and $7,000,000 in cash was paid during the fiscal period. Dollars 3,000,000 was paid in April 2015. Turning to our balance sheet. At March 3135, including investments fixed income securities, our cash and investments balance was $128,400,000 a decrease of $16,900,000 from December 3134.

Our cash and investments at September 3034 were $177,300,000 Our common shares outstanding at March 3135 were $59,400,000 which increased from $54,700,000 at September 3034, primarily due to the issuance of 3,300,000.0 shares for the Novartis acquisition. Also at March 3135, there were 15,652 shares of preferred stock outstanding. These preferred shares are convertible into 2,700,000.0 shares of common stock. Common shares outstanding including the conversion of our preferred shares would be 62,100,000.0. With that brief overview, I'll turn the call back to Chris.

Speaker 2

Thanks, Ken. During our last conference call, we set out a list of goals for calendar twenty fifteen. We are measuring our execution versus those goals and our investors should do the same. We have already achieved three of the goals and are on schedule to reach several more. We still have a lot of work to do, but we believe the achievement of these goals among others will help to build long term value for our shareholders.

There is a lot of exciting work going on at Arrowhead and the next several months are shaping up to be quite active indeed. We look forward to keeping you up to date on our progress and presenting data from the long term Chimp study and the ARK-five twenty clinical program at a special Analyst Day next quarter. I would now like to open the call up for questions. Operator?

Speaker 0

Thank you. Our first question comes from Alethia Young with Deutsche Bank. Your line is open.

Speaker 5

Hey, guys. Thanks for taking my questions. The first one I guess is with your update that you provided on three new cohorts, Is it possible to give us a little bit more color around maybe what are the hypotheses that you're studying there? And then as well like with the chimps just kind of nine new chimps just a little bit more color And I have some follow ups.

Speaker 3

I think we'd like to hold that for when we do the Analyst Day, Alethia. As we sort of implied in the presentation, there are competitively sensitive items here. And while we are going to give a our plan is to give a lot of information during the Analyst Day, we'd like to probably hold it for that last quarter. Otherwise, we would have gone ahead and said here during the presentation what was included in those cohorts. I don't know Chris if you want to elaborate on that, but

Speaker 2

No, think that's exactly right. We are as we said really excited about those new cohorts. I think it rounds out that Phase 2a study nicely. And the Chim study has been very exciting. We look forward to providing a lot of information during that day.

It really is frankly far too much information to I think to disclose any other way, but having a pretty in-depth Analyst Day. So stay tuned. That will be sometime next quarter. And I think that I think it's an important day

Speaker 3

for us.

Speaker 5

So have you guys said if it's single or multiple doses that you're going to be studying in the next cohorts?

Speaker 2

We haven't said that.

Speaker 5

Okay. Okay. Well then moving on to maybe AAT. Just it seems like you got to your dose maybe a little bit earlier than what my expectations were at least. And then maybe can you give us what the preclinical data suggested around how this correlates with what you're seeing in patients so that we can kind of get a read through maybe on where you might see an application goes again in patients?

Speaker 3

Yes. We of course didn't know what the dose would be. This was this crossover point I guess was internally there probably would have been as many people at this doses for the next dose maybe. So it's somewhere sort of in that range we thought there was a pretty good chance we'd crossover. But in truth this is now our second product in the clinic.

So we're starting to feel maybe that we see more of a clear trend to our animal data. But I think we felt the need to be cautious internally in over interpreting the animal data. But this feels like as we have said before that there seems to be a lot of similarity between humans and primates in sort of the dose responses that we see. The of course when it comes to a primate that's basically a normal gene and when we come to the patients that we're going to be dealing with disease genes. But I would say this was in the ballpark of where we were hoping to start seeing knock down and but it was hard to predict that we were going to actually see the knock down to cause us to go ahead and convert the patients here.

Speaker 5

Okay. And just sorry back to ARK-five twenty, your Analyst Day are you expecting 3Q or 4Q for that?

Speaker 2

Next quarter, third quarter.

Speaker 5

All right. Great. Thanks.

Speaker 2

Sure.

Speaker 0

Our next question comes from Yang with Jefferies. Your line is now open. Hi. This is Carmen on for Eun. Thanks for taking the question.

So for the multi dose study in 05/20 starting at one milligram, are you going to need to see the data there before moving into the two milligram cohort?

Speaker 3

So what the FDA wants to see is they want to see the data from this one mg per kg U. S. Study. They want to see the final study report from the Hong Kong HipARC 2001 study. And now we can say what the preclinical study they're interested They saw the interim data from the Chimp work and as you might imagine they found that pretty interesting and they want to see the report from that as well.

So they want to see all that to and that's the data package they're looking for to deal with the partial clinical hold.

Speaker 2

And also keep in mind that that's not that we don't expect that to be a limiting factor for our ex U. S. Studies. And we believe that we should be able to move reasonably quickly in Europe and Asia with those studies.

Speaker 0

Okay. Great. Thank you so much.

Speaker 2

Welcome.

Speaker 0

Our next question comes from Michael Yee with RBC Capital Markets. Your line is now open.

Speaker 6

Thanks. Good afternoon. A couple of quick ones. If you wanted to dose with interferon, you do need to start that in Phase 1a? Or had you already gotten permission for that?

Or can you do that? And is that where I think we're going here in the three cohorts? I guess is the first question.

Speaker 3

Well, we're certainly not implying that the three cohorts have interferon in them. So that's not anything that we're implying. But to come back to your question, we of course won't know until we get a regulatory read, but our belief is that just as we have really been able to dose with NUCs, we think we ought to be able to dose with interferon, which is also standard of care in hepatitis B. So it is not our thinking that we'd have to go back to Phase one to study that combination before we could study it clinically in Phase 2b. But we'll have to wait and see whether the regulators agree with us.

But that's our perspective and we met with a lot of investigators at EASL and that was Aaron's perspective as well.

Speaker 6

Okay. So just to be clear, it is a standard approved drug. So it's not like you need to go back to ask permission for that to dose together with ARK-five twenty because I think that that's certainly a regimen we'd all be interested in looking at from a safety perspective with one dose. But you're not implying at all that you're going that way. Just want to

Speaker 3

Well, yes, Michael, we have to get regulatory approval to do any study involving ARK-five twenty. I'm just saying that that we believe that the regulatory authorities at least in certain geographies especially are going to be likely to allow us to dose on top of interferon just as we believe that they're going to be comfortable with us dosing on top of NUCs.

Speaker 6

Okay. Guess the follow-up with that in the attempt to move to Phase 2b with multiple doses, you laid out some of the stuff you're thinking about to do that in The U. S. In Europe, does or I guess OUS, it does seem a little bit straightforward as you just commented. I guess what do you think the sort of gating factors are to starting that whether that be in Hong Kong or other regions?

How are we thinking about timing there to get a multiple dose started outside The U. S?

Speaker 3

Well, it's always a little hard to say because we're still in the regulatory process. So it's easier to answer that question when you've got your regulatory regulatory green light like we have with the FDA for The U. S. Study. We certainly have the sense that assuming we don't come up with any surprises chances are pretty good that we will start dosing over the summer.

But I don't want you to take that as guidance because guidance would imply more certainty than I can give any time I'm dealing with regulatory reviews. But it feels sensibly possible.

Speaker 2

And importantly as Bruce said, we are in that regulatory process right now. We're having those discussions. So as we said in the prepared remarks, we believe that this quarter we could start to see approvals to begin some of those studies.

Speaker 6

Okay. And then last question, sorry to come back to it the full circle. In the additional cohorts, cohorts, this has to all do with the Phase IIa correct? This is all single dose stuff correct?

Speaker 3

Yes. This is the Hong Kong study. This is the 2,001 study we're talking about. We have added three cohorts to that study.

Speaker 2

Haven't said if it's one or multiple doses however.

Speaker 6

I see. Okay. Thank you.

Speaker 4

Yes. Thank you.

Speaker 0

Our next question comes from Ted Tenthoff with Piper Jaffray. Line is now Great.

Speaker 4

Thank you very much. Just a little bit more clarity. So should we expect data from both three and four mg per kg cohort and also these new three cohorts next quarter and that's what you'll be reporting at the R and D Day?

Speaker 2

Yes. So expect that and also expect the long term or at least some of the long term Chimp data. We're going have an awful lot of data and we need to figure out how we're going to communicate that and when we're going to communicate that. But there will be an awful lot of data that we'll be going over from all of those during the Analyst Day next quarter.

Speaker 3

You know how it is Ted. I mean there's always that tension between what you can do and not lose your ability to prevent it present at big international meetings like AASLD and EASL and to not be prevented from publishing while giving investors enough to really understand the basics of what's in the data. So that's a tension that all of us in the industry face and we'll do our best to give as much information as we can without giving so much that we're precluded from scientific publication and presentation of the data. There's always that tension. I'm sure you're well aware of that.

Speaker 4

Good enough. All right. Thanks guys. We'll go forward to the R and D Day. Okay.

Great. Thank you.

Speaker 0

Thank you. I'm showing no further questions. I would now like to turn the call back to Chris Anzalone for closing remarks.

Speaker 2

I will thank you everyone for your attention and we look forward to seeing you next quarter.