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EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2015 - Q2
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Executives

Vincent Anzalone - IR Christopher Anzalone - CEO Bruce Given - COO Ken Myszkowski - CFO.

Analysts

Alethia Young - Deutsche Bank Michael Yee - RBC Capital Markets Ted Tenthoff - Piper Jaffray.

Operator

Ladies and gentlemen, welcome to the Arrowhead Research Fiscal 2015 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..

Vincent Anzalone Head of Investor Relations & Vice President

Thank you. Good afternoon, everyone. And thank you for joining us today to discuss Arrowhead's results for its fiscal 2015 second quarter ended March 31, 2015. With us today from management are President and CEO, Dr. Christopher Anzalone; Chief Operating Officer and Head of R&D, Dr. Bruce Given; 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 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 facts, including without limitation those with respect to Arrowhead's goals, plans and strategies, are forward-looking statements.

These include but are not limited to statements regarding the anticipated safety and/or efficacy of ARC-520, ARC-AAT, ARC-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 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-K 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 Dr. Christopher Anzalone, President and CEO of the company.

Chris?.

Christopher Anzalone Chief Executive Officer, President & Director

Thanks, Vince. Good afternoon, everyone, and thank you for joining us today. In review 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&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.

The portfolio includes the multiple patent families covering RNAi trigger design rules and modifications that we believe fall outside of key patterns controlled by competitors, combined with the chemistry portfolio constructed by Roche, we feel that we can work on any target an 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 improve instability once the risk is loaded, think of these and sophisticated RNAi activity enhancers.

Also included was an 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.

We 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 triggered structures and modifications as possible.

In order to tune each candidates and employee the optimum chemistries on a candidate by candidate basis. When these two frameworks are substantial in placed, a company shifts from developing the candidate it can make to developing the best possible drug for 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're currently testing the Novartis' chemistries to determine if they should be used in our most advance preclinical programs.

Our research in early development groups have also made some important advancement in DPC technology and in some of our preclinical programs. We published a paper describing our next generation DPC constructs, that use for proprietary mass in chemistries with increased stability and longer circulation times.

These constructs have the added benefits of allowing conjugation of the RNAi trigger directly to the DPC. All of these changes are designed to enable both subcutaneous administration and extra product 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 ARC-F12, our potential new drug candidate targeting factor 12 mediated diseases, such as hereditary angioedema and thromboembolic.

The studies we presented, demonstrate that ARC-F12 achieved deep dose dependent and durable knockdown of the target gene in rodent and primates studies.

In multiple dose primates studies with the IP administration once every four weeks approximately 90% knockdown was achieved after the first dose and even greater knockdown following the subsequent doses.

In a relevant mouse model of thromboembolism ARC-F12 showed a dramatic increase in exclusion times and appear to protect against thrombosis formations or clotting. ARC-F12 appeared to be generally well tolerated and no drug related changes in toxicity markers were observed in these animal studies.

We're in the process of conducting studies in additional models for hereditary angioedema or HAE to provide further data to decide if we will advance ARC-F12 as a clinical candidates and initiate IND enabling studies.

Patients with the 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 involved, frequent intravenous dosing of one to three times weekly and many patients do not response 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-1 antitrypsin deficiency or AATD.

We announced last week that we've completed the healthy volunteer portion or part A of the study and that we've been cleared by the data safety committee to do a transition 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 3 of the study.

AAT is an endogenous gene, so healthy volunteers with AAT -- without AATD produce functional AAT that can be easily measured with the simple blood draw. These early results suggest that in humans, we can knockdown endogenous genes that are expressed in the liver.

We've always been confident that this should 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 will be forward. We also made good progress in the clinical program for ARC-520 our candidate against chronic hepatitis B infection.

We have productive discussion 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 proceed with the HEP-R2004 clinical study within initial dose of 1 mg/kg.

We're pleased to be moving forward with that study here in U.S. and expect that it will generate valuable data about ARC-520s activity in a multi-dose setting. Thus our multiple dose Phase2B 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 to start 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 learned in clinical and non-clinical studies helped shape our strategy for the indication and much of what we are doing represents first for the field. of course this 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 programs since presenting early data at AASLD which I'm glad to add was notable because only single initial doses of ARC-520 elicited what we believe to be the first reliable import of significant S-antigen reduction in humans.

This relatively quiet period does not mean that we were ideal, to the contract we have been very busy and have learned a tremendous amount about ARC-520 and hepatitis B virus; here is 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 ARC-520 in nine chimpanzees chronically infected with hepatitis B. It has been going on for about a year and is nearing 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 ARC-520. We have generated a large amount of very exiting 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 ARC-520 may fit into a treatment strategy. The wealth of data, this chimp study and the single-dose Phase2A study have provided a very important insight 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 hypothesis and we have decided to test some of these new hypothesis in humans by adding three cohorts to the Phase2A study in Hong-Kong which remains blinded.

None of these employ doses greater than 4 mg/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 that flexible stance.

Unfortunately because of the new cohorts -- because one of the new cohorts is placebo controlled this will mean pushing back un-blinding of the entire study to next quarter rather than this quarter.

I appreciate that some will be disappointed, so we are changing guidance for release of the 3 mg/kg and 4 mg/kg results from second quarter to third quarter, but we did not anticipated expanding the Hong-Kong study when we set that guidance.

Our regulatory team and advisors agreed to un-blinding the study once all of the blind cohorts have run their course, is the prudent course of actions under these circumstances to maintain the integrity of the studies in the eyes of scientific community and the international regulatory authorities.

It is simply unwise and frankly uncommon in the pharmaceutical industry to un-blind cohort by cohort without a compelling reason to do so, such as our decision to un-blind the first two cohorts in preparation of an FDA filling.

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 Phase2A 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 7 cohorts of patients in a large Phase2A 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 scientist participate but also internationally recognized experts in this 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, Dr. Bruce Given.

Bruce?.

Bruce Given Chief Medical Scientist

Thank you, Chris, and good afternoon, everyone. As you heard from Chris our clinical development and regulatory teams have been very busy 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 HEP-ARC 2001 study of ARC-520.

As you recall this was a originally a single dose Phase2A 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 1 mg/kg and 2 mg/kg and as of our last quarterly conference call we had enrolled an additional two dose cohorts at 3 mg/kg and 4 mg/kg.

Observation periods are complete for these and the cohort remains blinded. We have since made protocol amendments to add three additional cohorts, two of which have received IRB approval to proceed and we expect a third to be approved as early as this month.

We have already enrolled and dosed 7 of 8 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 un-blinded the 1 mg/kg and 2 mg/kg cohorts last year in order to support an IND and other regulatory filings for multiple dose Phase2B studies. We expect to un-blind the entire Phase2A study which will include the 3 mg/kg and 4 mg/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 3 mg/kg and 4 mg/kg cohorts now and we would also like to be able to discuss those. However un-blinding cohort while other blinded cohorts are still running should only be done under limited circumstances such as for an FDA filing.

This is a marathon, and 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're committed to following GPC standards and regulatory norms in order to ensure as smooth a regulatory process as possible.

As Chris mentioned, we have already generated a great deal of information in the long-term chimps study and the now expanded Phase2A that we believe will prove important for HBV field. Once we're able to un-blind the entire Phase2A 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 and peer reviewed articles will emerge from the 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 Phase2B studies of ARC-520, we received clearance from FDA to proceed with the HEP-ARC 2004 study in the U.S. This is a randomized double blind, placebo controlled, multi-dose study of ARC-520 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 2:1 with eight patients receiving 1 mg/kg of ARC-520 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 2004 is to evaluate the depth of hepatitis-B surface antigen decline in response to multiple doses of ARC-520 compared to placebo. We intend to open three sites for enrollment. One site was opened for enrollment last week and patients screening has begun.

Site initiations for the other two are scheduled for the coming week after which they may begin recruiting and screening patients. As we have mentioned before, we still intend to proceed with additional core 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 publically 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-1 Antitrypsin deficiency which we short hand as AATD.

In just over two months we initiated a Phase 1 study, completed enrollment and dosing of three ascending dose cohorts and 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 applaud our clinical operations team for great execution and a successful start to this ground breaking 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 approvals to begin recruiting of Alpha-1 patients in the next week or so and we hope to add 3 to 5 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 ARC-AAT and the effects on circulating Alaph-1 Antitrypsin levels in patients with the disease.

The study plans enroll and dose cohorts of 6 participants each with participants randomized in a ratio of 2:1 active to placebo to receive a single intravenous injection of either ARC-AAT or placebo.

Dosing in patients with AATD will begin at 2.0 mg/kg of UNA and 1.0 mg/kg DPC, which was the highest dose used in Part A and then dose escalation will proceed according to protocol. The study evaluates participants grew 28 days following dosing with additional follow-up if needed every two weeks until AAT levels return to baseline.

We hope to complete the Phase 1 study by the end of 2015. While I have presented a healthy amount of work for our clinical team we're also starting to design the Phase 2 multiple dose study of ARC-AAT and some of the Phase2B combination studies of ARC-520, so stay tuned for more details about our plans later this year.

With that, I would like to turn the call over to Ken Myszkowski, Arrowhead's Chief Financial Officer.

Ken?.

Ken Myszkowski

Thanks Bruce and good afternoon everyone. As we reported today, our net loss for the three months ended March 31, 2015 was 28.7 million or $0.51 per share based on 55.7 million weighted average shares outstanding.

This compares with a net loss of 14 million or $0.31 per share based on 44.3 million weighted average shares outstanding for the three months ended March 31, 2014. Net cash used in operating activities during the second fiscal quarter was 16.4 million compared with 7.7 million in the prior year period and 24.2 million in the first fiscal quarter.

Cash used in operating activities during the quarter of 16.4 million primarily composed of research and development cost, mostly program cost for ARC-520 and program cost for ARC-AAT, as well as R&D salary and wages and related discovery research cost.

Total operating expenses for the three months ended March 31, 2015 were 29.7 million compared with 11.3 million for the three month ended in March 31, 2014.

The increase in the operating expenses compared to the year ago period are heavily influenced by a non-cash charge of 10.1 million 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 cost which increased 3.2 million during the period mostly related to ARC-520 as well as higher clinical cost which increased 1.2 million. Clinical costs have increased as we incur startup cost from our CRO related to the planned ARC-520 Phase2B studies.

We also incurred cost for our second clinical candidate ARC-AAT of about 2.9 million, while ARC-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 2014 is consistent with the drivers of the change in operating expenses, aside from the 10.1 million for acquired in process R&D cost. The consideration provided to the acquisition of the Novartis assets was cash and stock.

25 million of stock was issued during the fiscal period and 7 million in cash was paid during the fiscal period. $3 million was paid in April of 2015. Turning to our balance sheet, at March 31 2015, including investments in fixed income securities, our cash and investments balance was 128.4 million, a decrease of 16.9 million from December 31, 2014.

Our cash in investments at September 30, 2014 were 177.3 million. Our common shares outstanding at March 31, 2015 were $59.4 million which increased from 54.7 million at September 30, 2014 primarily due to the issuance of 3.3 million shares for the Novartis acquisition. Also at March 31, 2015 there were 15,652 shares of preferred stock outstanding.

These preferred shares are convertible into 2.7 million shares of the common stock. Common shares outstanding, including the conversion of our preferred shares would be 62.1 million. With that brief overview, I’ll turn the call back to Chris..

Christopher Anzalone Chief Executive Officer, President & Director

Thanks Ken. During our last conference call we set out the list of goals for calendar 2015. We are measuring our execution versus those goals and our investors should do the same. We've 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 presented data from the long term chimp study and the ARC-520 clinical program at a special Analyst Day in next quarter. I'll now like to open the call for questions.

Operator?.

Operator

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

Alethia Young

Hi, guys. Thanks for taking my questions. The first one, I guess, is with your update that you provided on the three new cohorts. Is it possible to give us a little bit more color around what are the hypotheses that you are studying there? As well like with the chimps, the nine new chimps, just a little more color around what is going on there as well.

And then I have some follow-ups..

Bruce Given Chief Medical Scientist

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 -- our plan is to give out a lot of information during the Analyst Day, we would 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 and I don't know Chris if you want to elaborate on that but..

Christopher Anzalone Chief Executive Officer, President & Director

No I think it's exactly right. We are as we said really excited about those new cohorts, I think it rounds out that Phase2A study nicely and the chimp study has been very exciting.

We look forward to providing the live information during that day and it really is frankly far too much information to disclose any other way, but having a pretty indebt Analyst Day. So stay tuned that will be some time next quarter and I think it's an important day for us..

Alethia Young

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

Christopher Anzalone Chief Executive Officer, President & Director

We haven't said that..

Alethia Young

Okay then moving on to maybe AAT. 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 pre-clinical data suggested around how this correlates with what you are seeing in patients, so we can kind of get a read through maybe where you might see an application of dose again in patients?.

Christopher Anzalone Chief Executive Officer, President & Director

We of course didn't know what the dose would be. This was crossover point, I guess was internally -- there probably would have been as many people at this doses for the next dose maybe. So, somewhere sort of in that range, we thought where there was a pretty good chance we've cross over. 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 and 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.

Of course when it comes to a primate that's basically a normal gene and when we come to the patients they're going to be dealing with diseased genes, but I'd say this was in the ballpark of where we're hoping to start seeing that down and but it was hard to predict that we're going to actually see the knockdown to causes to go ahead and convert the patients here..

Alethia Young

Back to ARC-520, your analyst day, are you expecting 3Q or 4Q for that?.

Christopher Anzalone Chief Executive Officer, President & Director

Its next quarter, third quarter..

Operator

Our next question comes from Eun Yang with Jefferies. Your line is now open..

Unidentified Analyst

Hi this is [indiscernible] for Yang, thanks for taking the question.

So for the multi-dose study and 520 is turning out 1 mg, are you going to meet see the data there before moving in to the 2 mg cohort?.

Ken Myszkowski

So what the FDA wants to see, is they want to see, is they want to see the data from this 1 mg/kg U.S.

study, they want to see the final study report from the Hong Kong HEP-ARC 2001 study and now we can say what the preclinical study they're interested in, they saw the interim data from the chimp work and as you might imagine they found that pretty interesting and then they want to see the report from that as well.

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

Christopher Anzalone Chief Executive Officer, President & Director

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

Operator

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

Michael Yee

A couple quick ones. If you wanted to dose with interferon, do you need to start that in Phase1A or had you already gotten permission for that? Or can you do that? And is that where I think we are going in the three cohorts? I guess, is the first question..

Christopher Anzalone Chief Executive Officer, President & Director

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 just as we have really been able to dose with NUCs we think, we got to be able to dose with interferon which is also standard for care in Hepatitis-B.

So it is not our thinking that we’d have to go back to Phase 1 to study that combination before we could study it clinically in Phase2B. But we'll have to wait and see whether the regulators agree with us. So, that's our perspective and we met with the lot of investigators at EASL and that was their perspective as well..

Michael Yee

Okay. 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 ARC-520, because I think that is certainly a regiment we would all be interested in looking at from a safety perspective with one dose.

But you are not implying at all but you are going that way?.

Bruce Given Chief Medical Scientist

Mike, we have to get regulatory approval to do any study involving ARC-520, I'm just saying 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..

Michael Yee

Okay. I guess to follow-up with that, in the attempt to move to Phase2B with multiple doses, you laid out some of the stuff you are thinking about to do that in the U.S. In Europe, it does, or I guess O-U.S. it does seem a little more straightforward as you just commented.

I guess, what do you think the gating factors are to starting that, whether that be in Hong Kong or other regions? How would are we thinking about timing there, to get multiple dose started outside the U.S.?.

Bruce Given Chief Medical Scientist

Well it’s 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 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 take that as guidance, because guidance would imply more certainty then I can give any time I’m dealing with regulatory reviews, but it feels sensibly possible. .

Christopher Anzalone Chief Executive Officer, President & Director

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..

Michael Yee

Okay. Last question, sorry to come back to it, but coming back full circle.

In the additional cohorts, this has to all do with the Phase2A, correct? This is all single dose stuff, correct?.

Bruce Given Chief Medical Scientist

Yes. This is the Hong-Kong study, this is the 2001 study we are talking about we have added three cohorts to that study. .

Christopher Anzalone Chief Executive Officer, President & Director

We haven't said if it's one or multiple doses, however..

Michael Yee

I see. Okay, thank you..

Operator

[Operator Instructions] Our next question comes from Ted Tenthoff with Piper Jaffray. Your line is open. .

Ted Tenthoff

Thank you very much. Just a little bit more clarity.

Should we expect data from both 3 mg/kg and 4 mg/kg cohort and also these new three cohorts next quarter and that is what you will be reporting at the R&D day?.

Christopher Anzalone Chief Executive Officer, President & Director

Yes.

So expect that and also expect the long term or at least some of the long term chimp data we're going to have an awful lot of data and we need to figure out how we're going to communicate that and when we are 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 in next quarter..

Bruce Given Chief Medical Scientist

How it is Ted. I mean there is always that tension between what you can do and not lose your ability to present it 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 is always that tension I'm sure you are well aware of that..

Ted Tenthoff

Good enough. Thanks, guys. Looking forward to the R&D day..

Christopher Anzalone Chief Executive Officer, President & Director

Okay. Thank you..

Operator

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

Christopher Anzalone Chief Executive Officer, President & Director

Well. Thank you everyone for your attention and we look forward to seeing you next quarter..

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