Geron Corporation (GERN) Q3 2016 Earnings Report, Transcript and Summary

Good day, ladies and gentlemen and welcome to the Q3 2016 Geron Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] I would now like to introduce your host for today's conference Anna Krassowska. You may begin.

Thank you. Good afternoon, everyone, and thank you for joining us for Geron third quarter 2016 earnings call. With me this afternoon are Dr. John Scarlett, our President and Chief Executive Officer; and Olivia Bloom, our Executive Vice President of Finance and Chief Financial Officer. Today we issued a press release that reported results for the third quarter ended September 30, 2016. This release can be found on our website at www.geron.com. Today’s call is also being webcast live on our website and will be available for replay through December 3rd. Before we begin, please note that except for statements of historical fact, the statements during this conference call are forward-looking statements under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These include, without limitations, statements regarding, the timeline, milestones, prospects and plans for Imetelstat, including the timing and current of additional data reviews and the outcome of those reviews related to IMbark and IMerge, health authority and IRB approvals of a protocol amendment for IMbark, the therapeutic potential and safety of imetelstat Janssen's diversify patent coverage, potential payments under the Janssen collaboration agreement and financial and operating projections are requirements. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties include without limitation that imetelstat is safe and efficacious in IMbark and IMerge, whether IMbark and IMerge continue to proceed without any delays cause by health authority or IRB’s or any other factors one or both of the trials discontinued Janssen is able to timely collect the requisite data from IMbark and IMerge, imetelstat that will overcome clinical safety and efficacy technical, scientific manufacturing and regulatory challenges. Geron patterns maintain their validly and whether Geron will actually receive continuation milestone and royalty payment from Janssen. Additional information and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron’s periodic reports filed with the Securities and Exchange Commission under the heading Risk Factors, including Geron’s Quarterly Report on Form 10-Q for the quarter ending September 30, 2016. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements reflect future information events and circumstances. We’ll begin today's call with the summary of the 2016 third quarter operating results from Olivia, and then Chip will review recent events and discuss ongoing activities with the imetelstat clinical trials are being conducted by Janssen. Olivia?

Thanks, Anna. Good afternoon. For the third quarter of 2016, the Company reported a net loss of $3.6 million or $0.02 per share compared to net income for the third quarter of 2015 of $27.2 million or $0.17 per share. Net loss for the first nine months of 2016 was $21.1 million or $0.13 per share compared to net income for the first nine months of 2016 of $8.5 million or $0.05 per share. Revenues for the three and nine months ended September 30, 2016 were $5.1 million and $6.1 million, respectively, compared to $35.4 million and $36.2 million for the comparable 2015 periods. Revenues for the three and nine month periods ending September 30, 2016 included license fee revenue of $5 million which represents an upfront payment due under a license agreement with Janssen Pharmaceuticals, Inc., which is an affiliate of Johnson & Johnson that is separate from Janssen Biotech Inc., the entity that is collaborating with Geron on the imetelstat program and hematologic malignancies. Areas are focused for Janssen Pharmaceuticals include neurological and infectious diseases. The license agreement with Janssen Pharmaceuticals was signed and became affective in September 2016. The licenses grant certain rights to our specialized oligonucleotide backbone chemistry and novel amidates and exclude any rights to imetelstat for Telomerase Inhibition. Revenue recognition criteria for the upfront payment was met in September 2016. Revenues for the three and nine months ending September 30, 2015 included the four recognition of the $35 million upfront payment from Janssen Biotech as collaboration revenue upon the revenue recognition criteria related to the upfront payment being met in the third quarter of 2015. This upfront payment was received in December 2014 in connection with the effectiveness of the imetelstat collaboration agreement with Janssen Biotech. Total operating expenses for the three and nine months ended September 30, 2016 were $9 million and $27.9 million, respectively, compared to $8.3 million and $28.1 million for the comparable 2015 periods. Research and development expenses for the three and nine months ended September 30, 2016 were $4.3 million and $13.9 million, respectively, compared to $4.1 million and $13.8 million for the comparable 2015 periods. General and administrative expenses for the three and nine months ended September 30, 2016 were $4.7 million and $14 million, respectively, compared to $4.3 million and $12.9 million for the comparable 2015 periods. Year-to-date operating expenses for 2015 also included restructuring charges of $1.3 million in connection with the company’s organizational resizing announced in March 2015. The increase in research and development expenses for the three and nine month periods ending September 30, 2016, compared to the same periods in 2015, primarily reflected the net result of higher costs for Geron's proportionate share of clinical development expenses under the imetelstat collaboration with Janssen Biotech, partially offset by reduced personnel-related costs resulting from the March 2015 organizational resizing and lower costs for the manufacturing of imetelstat drug product. We expect overall research and development expenses to be higher in 2016 compared to 2015 as the clinical development of imetelstat continues in collaboration with Janssen Biotech. The increase in general and administrative expenses for the three and nine month periods ending September 30, 2016, compared to the same periods in 2015, primarily reflected higher non-cash stock-based compensation expense and an increased allocation of facilities and other overhead costs to general and administrative activities. We ended the third quarter of 2016 with $129.8 million in cash and investments; we have not incurred any impairment charges on our marketable securities portfolio. I will now turn the call over to Chip to review recent company events. Chip?

Thanks, Olivia. Good afternoon, everyone, and thank you for joining. I like to begin with a brief overview of the imetelstat abstracts that have been accepted for presentation at the American Society of Hematology or ASH Annual Meeting in December. As a reminder Janssen and Geron did not submit any abstract to ASH related to imetelstat clinical data this year. However as part of the translation research program for imetelstat Janssen has been sponsoring numerous preclinical studies to explore the effects of the imetelstat in other hematologic myeloid malignancies. There will be three non-clinical presentations at ASH which describe data from such ongoing work. The abstracts related to these presentations are available online on the ASH website and information regarding presentation times is also contained in a press release we issued this morning. In compliance with the embargo policies of ASH. On this call I will limit my comments to the topics for each of the abstract. First in an oral session Dr. Steve Lane from the University of Queensland, Australia will present data on the activity of the imetelstat in a non-clinical model of AML. Dr. Lane and his colleagues have been continuing their exploratory work to understand the potential clinical efficacy of the imetelstat in AML by using pre-clinical models derived from patient samples. Second during the post-recession scientists from the University of California and San Diego and Janssen R&D will present data from non-clinical models of chronic myeloid leukemia and blast crisis. This work provides further support for the potential impact of imetelstat on leukemia stem cells. Third scientists from The University of Bern in Switzerland in collaboration with clinical investigators of the prior Phase II study in patience with essential thrombocythemia and Geron will present a poster describing the Dynamics of Telomere Length in patients with ET who are treated with imetelstat. These data extend the clinical evidence that imetelstat that treatment in ET patients may suppress the neoplastic clones underlying the disease. Lastly a poster presentation will be available from the Janssen commercial team that reviews treatment patterns and outcomes of patients with myelofibrosis from United States medical claims databases. Although, this poster does not contain imetelstat data, it is relevant to the imetelstat program. The analyses support published observations by others that suggest that median overall survivals regularly reduced once patients with MF fail or discontinue ruxolitinib the only approved drug for MF today. These data further underscore the unmet medical need in MF in this patient population which is currently being tested in the ongoing imetelstat MF trial being conducted by Janssen. Next, I'd like to briefly summarize the outcomes of the planned internal data reviews conducted by Janssen during the third quarter and highlight the recent actions taken by them related to the two ongoing imetelstat studies IMbark and IMerge. I will start with IMbark. This Phase II trial was originally designed to evaluate two different dose levels of imetelstat in patients with Intermediate-2 or High risk myelofibrosis or have relapsed after treatment of the JAK inhibitor. The co-primary endpoints of IMbark which are spleen volume reduction and total symptoms respond will be assessed in a 24-week time point. As you'll recall, the first internal data review of IMbark was conducted as planned after 20 patients for each dosing arm had been followed for at least 12 weeks. Outcomes determined by Janssen from this first internal review included the following. First, the safety profile at both doses was consistent with prior clinical studies in imetelstat in hematologic malignancies and did not identify any new safety signals. Second, let me start with lower starting dose of 4.7 milligrams per kilogram did not show sufficient activity among the first 20 patients assessed the early 12-week point. Nor did the data suggest that additional time on drug would result in an adequate response 24 weeks. Thus the 4.7 milligrams per kilogram dosing arm did not warrant further investigation and it has been closed to further enrollment. Third, the higher starting dose of 9.4 milligrams per kilogram showed encouraging trends in efficacy among the first 20 patients and warranted further investigation with patients being allowed to continue to receive the imetelstat. However, because not enough patients in this trial met the predefined 12-week interim criteria to clear the dose adequate, new patient enrollment is being suspended while the 24-week data can be collected and analyzed. Janssen has informed us that as of today over 100 patients have been enrolled in IMbark across both dosing arms compared to over 90 patients that were enrolled and the enrollment suspension is announced in September. The reason for the increase in enrollment from over 90 to over 100 is because there were a number of patients who are already in screening for the trial and investigators were allowed to enroll those patients in 9.4 milligrams per kilogram dosing arm. Since the IMbark internal data review Janssen has submitted to health authorities for review implants a protocol amendment that includes allowing investigators to increase the dose of eligible patients in the 4.7 milligram per kilogram dosing arm to 9.4 milligrams per kilogram. Prior to being implemented this protocol amendment was also be reviewed and approved by each clinical sites institutional review board or ethics committee. Until that time investigators can continue to treat those patients with imetelstat using 4.7 milligram per kilogram does. By the end of the second quarter of 2017, Janssen plans to conduct a second internal data review for IMbark including patients who enrolled at 9.4 milligrams per kilogram starting dose and have been followed for at least 24 weeks. This timing also allows some of the more recently enrolled patients at the 9.4 milligrams per kilogram starting dose to reach the 24-week time point for inclusion in the second review. There are a number of possible outcomes following the second review. Enrollment in the 9.4 milligrams per kilogram dosing arm could be resumed a new dosing arm could be added or the trial could be closed. If enrollment resumes, the primary analysis is projected to occur after all patients claim to be approximately 100 patients enrolled and treated in the 9.4 milligrams per kilogram arm as a starting dose have been followed for at least 24 weeks. Therefore because the enrollment is currently suspended the timing of the primary analysis is uncertain. The separate analysis is planned for patients who enrolled in the 4.7 arm whether another dose was subsequently increased to 9.4 milligrams per kilogram. Moving on to IMerge. This study is a Phase II/III clinical trial evaluating imetelstat and patients with low or intermediate-1 risk myelodysplastic syndromes, or transfusion independence and have relapsed after or a refractory to treatment within erythropoiesis-stimulating agent. IMerge has two parts, one is the Phase II open-label single-arm design and up to 30 patients. Part 2 of the study is a Phase III randomizes placebo control of up to 170 patients. With Part 1 being fully enrolled no further patient enrollment occurring as originally design. The primary endpoint in IMerge is red blood cell transfusion independent independence for a consecutive 8-week period with 24 weeks red blood cell transfusion independence as key secondary endpoints. In the third quarter Janssen conducted an internal data review for IMerge from a subset of patients from Part 1. Based on this review Janssen determined that IMerge and safety and efficacy appears to be consistent with the data reported from the MDS patients in the Mayo Clinic pilot study we are encouraged by these preliminary data in the trial currently continues unmodified. Janssen plans to conduct a second internal review for IMerge by the end of the second quarter of 2017 including longer follow up for all Part 1 patients. We expect Janssen to assess the benefit risk profile imetelstat in Part 1 as well as data from imetelstat program as a whole. And regulatory review before deciding whether to move forward Part 2 of IMerge. If Janssen moves forward with Part 2 we expect the Phase III portion of the trial to be open for enrollment in 2017. We expect Janssen to submit data from Part 1 of IMerge to consider presentation in a Medical conference in the future. We in Janssen continue to be committed to advancing the development of the story novel drug. Before we open the call to questions, I will also note that our search and evaluation process to identify and evaluate oncology products, programs or companies for potential acquisition continues and we have not yet identified such again. Thanks very much for your attention. We would be pleased to answer questions in the time we have remaining. With that operator, let’s open the call to questions.

Thank you. [Operator Instructions] And our first question comes from the line of Roy Buchanan from Janney Montgomery. Your line is open.

Hi, great. Thanks for taking the question. My first question actually something John just had discussing that IMerge evaluation by Janssen that should happen in 2Q, you mentioned regulatory review can you describe precisely what that means is that the prior review of the clinical whole imetelstat is that something else?

We plan to submit information as you would expect to regulators I think that's what that implies.

Okay. So we're going to wait for that feedback to come back from the FDA…

I don't think we will make any comments further about any regulatory matters Roy.

Okay. Right so my next question is and I think maybe the last quarter that you mentioned our presentation at ask but I haven't found yet might speak to this but the patient population for IMbark how do we think about or maybe help us think about the relapsed refractory population so about 50 of the Mayo mylofibrosis patients were prior JAK patient. Can you kind of help us maybe point in the right direction, how to think of the relapsed refractory population, how to think of their potential outcomes.

Yes, happy to do so. So the relapsed refractory population as we've described on previous calls and presentations Roy is as far as I know and as far as I think we've been able to identify this is the only time this patient populations been really fully addressed. So these are not just JAK in the IMbark study these patients are not just patients who have been previously exposed to or treated with a JAK inhibitor. But actually there are patients who have - who are actually did not respond initially to JAK inhibitor that's obviously the refractory and or their patients who have had deterioration or progression of their symptoms of both symptoms and spleen volumes while on a JAK inhibitor. So this is quite a severely ill population and I think that it represents a more ill population than any that we've studied previously and that as far as I know we've been studying by other drugs in the space in the field.

Okay. Great. Last question that you mentioned from Janssen the drugs treated population. Does that population at all or…

Yes. It does actually I mean within the confines of not being a clinical - natural clinical study. It was a study of claims databases. It was pretty interesting. I mean you can read the poster and we're not going to go into it and doubt. But they recapitulated sort of whether there was or was not a survival benefit associated with drugs treatment. And then they also calculated a mean survival in patients who had actually discontinued treatment with drugs. I mean we don't know exactly why that presumably because they were no longer responding and it was very substantial difference. So I think that it really did a nice job of recapitulating how quite there will be patients are.

Okay. Great that's helpful. Thanks. And last question it’ll be quick one. The CML poster presentation that you mentioned abstract and I think this is going to be like getting blood from a stone, but they have - at the end a strong rationale for trial any comment on the potential for a CML trial?

So I don't think we're ready to talk about CML or really any of the other indications that we've been chatting about. I will say that one of the benefits potentially or at least one of the rationale for studying imetelstat in hematologic myeloid malignancies are that many of these if not all of them of these types of malignancies appear to be associated with highly proliferative neoplastic clonal populations. And so one is tempted at least to think that there may be some opportunity beyond in multiple different hem malignancies beyond those that we've studied and we've talked about that in the past. But whether or not there's anything specific that’s going to come out of for example this program or this abstract or any others. We're certainly not prepared to articulate anything beyond the studies that we started today.

Okay great. And sorry last one. Do you anything planned at ASH this year Investor event.

We don't have an Investor event planned this year.

Okay, great. Thank you.

Thanks a lot Roy. Thanks for your interest.

Thank you. And our next question comes from the line of Alex Schwartz from Stifel. Your line is open.

Hi, Chip and team. Congrats on a continued progress.

Thanks.

Just two questions, if I may. How the interim analysis of the 2Q mylofibrosis in MDS. We communicate to us will be in a press release similar to like September interim analysis or [indiscernible] are you kind of someone captive to your partner's wishes if you could elaborate on any of that that would excellent.

Great, question. It gets my usual answer it depends. We've always said Alex is that if there were changes made in the program and/or any of the studies that we would then report on those changes. The change that was made to the dosing arms and IMbark in the MF study clearly qualified for that. So that's why we - and have a press release and actually a conference call surrounding that and at the same time it seemed churlish not to note that the MDS study was continuing unchanged. I think it is highly likely that there will be some information available especially from the MDS study since we have effectively finished and we will have pretty much fulsome data on the part one. I think it would not be unreasonable to expect that we would have some information around that. But we're not promising anything specificity. So that's pretty much what I would say today. If there are changes in the program then we will make an announcement and we're pretty quickly disclosed that those kinds of things.

Yes. Absolutely. Well the additional color definitely helps. The other question I had is congrats on the upcoming ASH presentations. You've produced some interesting preclinical data, imetelstat in AML, when can we expect to see clinical development in that indication as much as you can talk about it and what might be some relevant competitive therapies or where do you kind of see it fitting into the treatment landscape?

Yes. That’s a great question. Thanks. Well, first of all I think both we and Janssen have always been intrigued by the potential in AML. Although, Dr. Tefferi never actually - as far as I recall never actually presented the results is extremely early, single-agent activity and we've always said that there was anti-leukemic activity that was observed in those patients and you'll recall that those were patients with the last phase of MF which is a particularly difficult secondary form of AML to treat and most of those patients die very quickly unfortunately. So we did see anti-leukemic activity and we've also stated before that it would be necessary in our and I believe also Janssen’s view to actually treat patients with combination therapy. With regard to other therapies, I think all I can say about that is that and with regard to sort of where you might aim. I think our biggest challenge which is a common challenge in the treatment of AML is that many of the existing therapies do have significant erythropoiesis associated with them. If you look at the hypomethylating agents there's no question about that, right. And they're quite toxic and so on one hand one would like you probably going to need to do some form of induction therapy, because imetelstat takes a little bit longer to get going and get acting at least in other indications. But with regard to the exact type of drugs and or the exact nature of those combinations drugs that's actually under consideration at the moment. I don't really have anything to announce or give you any specifics around AML, but I can tell you it continues to remain very interested.

Okay. Very good. Congrats on the quarter.

Thank you very much.

Thank you. And our next question comes from the line of Charles Duncan from Piper Jaffray. Your line is open.

Good afternoon. This is Sarah on for Charles. So glad to hear the progress from you guys today. I have two questions. First one, can you help us to understand why it might take 24 weeks to show an impact from imetelstat and its mechanism in MF?

Sure. I would remind everyone that the standard length of time in most studies of MF even amongst the JAK inhibitors is actually most of the primary endpoint or 24 weeks. That was COMFORT-1, the ruxolitinib. COMFORT-1 which was the initial study used to support an approval was actually had a primary analysis at 24 weeks. I don't believe we've ever seen 12-week data actually from that study or any other studies for that matter that I'm aware of JAK inhibitors. COMFORT-2, the second study was as I recall a 48-week time point. So these diseases and other studies done by other manufacturers with other JAK inhibitors in this space have all required fairly lengthy periods of time before they read them out. And I think that's not so much of a reflection necessarily of the mechanism of action, but I think it's actually a reflection of the fact that these patients develop most of their anatomic abnormalities including bone marrow fibrosis, including this fundamentally and many of the phony changes that you see in other changes you see as a result of MF over some period of time and just getting reversal does take a fairly lengthy period of time. So I think it's better safe than sorry. And we don't actually - this is an experiment in patients with IMbark is to a more severely ill patient population. So we don't really know exactly how long that would take, so 24 weeks seems to be a very reasonable timeframe based on prior experiences with other drugs.

Thanks. That’s helpful. Look forward to those results. And then second question, so I noticed there is an ASH abstract with data from imetelstat and essential thrombocythemia or you see the increase in our [indiscernible] with decreased drive mutation burden. Is that new data this year and does that support what we think the mechanism of this drug is?

Well to take the latter first, yes, I think it does strongly support it. Again I don't want to go into great detail about the specifics of the data in the abstract. But I'll just simply say that at a high level certainly telomere length is often been thought to be you know associated with you know shorter telomere length is often been thought to be associated with very rapidly dividing ligament cells and we know that there were a variety of different things in the past that have been you know talked about in the New England Journal paper and so on. In ET patients that when they had strong clinical responses. There was also a decrease in mutational burden in the blood and so forth. Now this extends some of those observations specifically to tumor length which is probably we think closely associated with the mechanism of action of the drug. So overall I think that this was an important additional observation made in a group of patients - from patient materials and patients themselves who have been followed for off a long period of time on the drug and who have very well characterized clinical observations. So I applaud Gabriela Baerlocher and her colleagues who have continue to really get the most of this patient data set and really understanding even further that how the drug probably works which is all associated with suppression of malignant progenitor cell clones.

Great. Thanks for taking the question.

Thank you.

Thank you. And our next question comes from the line of [indiscernible]. Your line is open.

Thank you for taking my question. I just wanted to clarify for the IMbark study the primary analysis will be based on 100 patient or 200 patients receive imetelstat for 24 weeks?

Yes, so it’s now a 100 patients in the 9.4 milligram per kilogram arm. Since we dropped the enrollment - stopped enrollment in the 4.7 milligram per kilogram arm, obviously you had a pick a number of patients in the regional number patients in the 9.4 was expected to be 100. So that’s the number of that is current being expected for the primary analysis.

So but the trial will only enroll 100 patients with the lower dose dropped or…

No, they are will have been however many patients that were already enrolled in the lower dose arm well they won’t stop they continue on and then all of the new patients that while there were a number of patients that were in screening and we’ve set those patients were put on to 9.4. Now enrollment today is expanded in the 9.4 arm and so we don’t know today whether I will get to a 100 patients in that arm. If the study as we started it would be the expectation we would get there if it’s not restarted and something else is done they we won’t.

I see. So if it is the enrollment restart and then you will enroll a total of 100 patients for the 9.4 dose plus whatever number of patients already in the 4.7 dose is that…

That’s correct was one minor additional comment. The 100 patients for the primary analysis is actually those patients were started 100 patient were started on 9.4 as the starting drugs. So the patient who get changed to 9.4 from 4.7 they don’t count for that 100. Just - all the more confusing.

It's good. So I understand it now. So the lower dose, patients started with lower dose just keep their once the amendment is completed they will receive higher dose. But they are not included in a primary analysis.

That's right. There will be a separate analysis for the low dose patients or patients that started at low dose and went to a higher dose.

Got it. That's very helpful. Thank you.

Sure.

Thank you. And our next question comes from the line of Thomas Yip from FBR & Company. Your line is open.

Hi, everyone. Good afternoon. Thank you for taking my questions. I guess first just want to learn more about IMbark specifically regarding the protocol amendment in progress. What should we expect to be the main focus of the review, will it be more weighted on safety or more weighted on efficacy.

There's a good question. I usually resolutely don’t try to predict what regulatory authorities or health authorities will focus on. We obviously are giving them all the necessary information. I certainly if I understood your question right which was what will they focus on now. Olivia shaking her head at me and saying I may have misunderstood your question maybe you could restate your question.

I mean that was - primarily my point is that they have the data so far for both final dose imetelstat, so in the process of approving the patients in the low dose arm to be given a high dose in the future. Would they be look at, I assume they will look at data from both doses but would they be focused primarily on the safety off those two doses or the efficacy of those two doses.

Yes. Thomas they will, I think everyone whether you were a sponsor or a regulator. I think that you would look at the same things which are fundamentally is there a meaningful difference in safety or risk profile or risk benefit profile in one arm versus another, we obviously made the conclusion that there was a difference in the low dose and that the efficacy was not adequate and that's by definition a change in the risk benefit profile. And I guess we've stated our point of view which is are advancing the state of their point of view that by offering an amendment to increase patients to the 9.4 that they feel comfortable that patients who would move from 4.7 to 9.4 would enjoy at least as good if not better presumably a better benefit risk profile than at the 4.7. I think beyond that it's pretty hard to read everybody's mind but I think all of that will be taken into consideration. Janssen certainly out by offering us that amendment, I think made it clear to their point of view and I would confirm whether is to say is that that would be a reasonable thing for people to do - to go to the higher dose.

Sure. That makes sense. Thanks for the explanation. And also following the protocol amendment I mean I know you can read their minds. But is it possible for them to recommend other dose that is other than 4.7 milligram or 9.4 milligram.

Who is them in this case?

I'm guessing mostly, you mentioned regulatory agencies. I am assuming the FDA and perhaps BMA?

Well usually in protocol amendments one puts forward a protocol amendment and if it's agreed upon it goes forward if not there's a conversation of some nature. And I suppose it's entirely possible within that conversation that they could say they would not be comfortable with that. But clearly the sponsor in this case who said that they are and usually the sponsor has the most data and so might you have to justify it or what have you. But that would be the general gist of things would be kind of makes sense. We don't have - I mean let me be very clear, we don't have. We have very, very limited data in MF or for that matter really most diseases, but in MF in particular any of the malignancies at lower doses intermediate between 4.7 and 9.4 other than the MDS which is obviously 7.5. But in MF the majority of our information is at these two doses now. So it would be - it's possible someone could ask for information or speculate on what might happen, but it would be hard for us to know our priority. So I think we’ve made our best. We've put our best going forward for the 9.4.

Sure. That’s reasonable. One final question, can you please remind us what should we expect at the second internal review of both IMbark and IMerge trials that’s expected in the second quarter 2017?

Well, with regard to IMerge, the MDS study, the design of that study is that there is a Part 1 which was the open label sort of lead in if you will hoping to recapitulate some of the types of responses seen in the open label study that I and Tefferi conducted in a much smaller number of patients. And so we should be in a position or Janssen should be in a position to determine at some point after seeing the results from the Part 1 whether or not proceed to Part 2 which as you may recall is already part of the protocol and it’s a randomized placebo-controlled study of imetelstat in MDS and it’s intended to be a Phase III study. So at some point there will have to be some decisions made whether to proceed or not that. With regard to IMbark, we've commented that there are a couple of different things that could happen. The first one is that the study could be restarted at 9.4 milligrams per kilogram and continued on this and we talked about in the previous discussion with Ling. That would go presumably to 100 for the primary analysis, a 100 with started on 9.4 in total. Another possibility is that arm could be dropped I guess another could be substituted it's possible, but it could be dropped or the study - that trial could be stopped altogether. Those are kind of the things that we've laid out and I think that after this interim analysis is one our interim review I think we should be in a position to hopefully make some of those decisions.

Okay. Sounds good. Thanks again for the clarification and looking forward to hearing more from imetelstat.

Okay. Thanks a lot. I appreciate your time and appreciate your interest.

Thank you. And that concludes today’s question-and-answer session. I would like to turn the call back over to Dr. John Scarlett for closing remarks.

I'd just like to thank everyone for joining and following the Company. We look forward to communicating future results in future conference calls. Everybody have a good day. Thanks.

Ladies and gentlemen, thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone have a great day.