Earnings Labs

Geron Corporation (GERN)

Q4 2017 Earnings Call· Mon, Mar 19, 2018

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Transcript

Operator

Operator

Good day, ladies and gentlemen and welcome to Geron’s Fourth Quarter and Full Year 2017 Earnings Conference Call. [Operator Instructions] Now I’d like to introduce your host for today’s conference Anna Krassowska, Head of Investor Relations. Please go ahead.

Anna Krassowska

Analyst

Thank you, James. Good morning, everyone, and thank you for joining us for the Geron fourth quarter and year end 2017 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. On Friday we issued a press release that reported results for the fourth quarter and year ended December 31, 2017. 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 April 20. 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 expectations; plans; timelines and prospects for imetelstat, including the continued development of imetelstat by Janssen through the IMbark and IMerge clinical trials, and data from the clinical trial suggest imetelstat is safe and effective, but Janssen will make a continuation decision and that Geron expects it to occur by the end of the third quarter of 2018, potential milestones and payments under the Janssen collaboration agreement and financial or operating projections or 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 whether imetelstat shows safety and efficacy in IMbark and IMerge, Janssen decides to continue developing imetelstat and provides a positive continuation decision and if so informs Geron by the end of the third quarter of 2018, the FDA or other help authorities or IRB’s or any other factors required that IMbark and/or IMerge be delayed or discontinued and Geron will actually receive continuation milestone and royalty payments from Janssen on the terms in the collaboration agreement. 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 Annual Report on Form 10-K for the year ending December 31, 2017. 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 to reflect future information events or circumstances. We will begin today’s call with a summary of the 2017 fourth quarter and annual operating results from Olivia, and then Chip will review ongoing activities of the imetelstat clinical trials being conducted by Janssen. Olivia?

Olivia Bloom

Analyst

Thanks Anna. Good afternoon. For the fourth quarter of 2017, we reported a net loss of $7.4 million or $0.05 per share, compared to $8.5 million, or $0.05 per share for the comparable 2016 period. For the year ended December 31, 2017 we reported a net loss of $27.9 million or $0.18 per share compared to $29.5 million or $0.19 per share for the comparable 2016 period. Revenues for the fourth quarter of 2017 were $191,000 compared to $94,000 for the comparable 2016 period. Revenues for the year ended December 31, 2017 were $1.1 million compared to $6.2 million for the comparable 2016 period. Revenues in 2016 included the full recognition of an upfront payment of $5 million from Janssen Pharmaceuticals Inc. under a license agreement that was signed in September 2016 for certain rights of specialized oligonucleotide backbone chemistry and novel amidates. Research and development expenses for the fourth quarter of 2017 were $2.5 million compared to $4.1 million for the comparable 2016 period. Research and development expenses for the year ended December 31, 2017 were $11 million compared to $18 million for the comparable 2016 period. The overall decrease in research and development expenses in 2017 compared to 2016 primarily is due to lower costs for our proportionate share of clinical development expenses under the imetelstat collaboration with Janssen Biotech Inc. and reduced personnel related costs. General and administrative expenses for the fourth quarter of 2017 were $5.5 million compared to $4.8 million for the comparable 2016 period. General and administrative expenses for the year ended December 31, 2017 were $19.3 million compared to $18.8 million for the comparable 2016 period. The overall increase in general and administrative expenses in 2017 compared to 2016 primarily is a net result of higher non-cash stock-based compensation expense and increase consulting…

John Scarlett

Analyst

Thanks Olivia. Good morning, everyone and thank you for joining. This morning I’ll start my remarks with a summary of the results from the latest internal data review conducted by Janssen on the IMbark, and an update on the projected timing of the protocol specified primary analysis for IMbark and the subsequent potential continuation decision from Janssen. I’ll then conclude with the status of the IMerge trial including a recap of the data that was recently presented at the American Society for Hematology or ASH Annual Meeting that was in last December. As a reminder, IMbark is a Phase 2 clinical trial designed to test two doses of imetelstat 9.4 milligrams per kilogram or 4.7 milligrams per kilogram administered every three weeks in intermediate-2 two or high-risk MF patients who are refractory-2 or have relapsed after treatment with the JAK inhibitor. The planned March 2018 data review was primarily conducted to enable a protocol amendment that will allow the long-term treatment and follow up of patients in the trial including for survival. And reviewing the data which was based on January 2018 data cut, the Collaboration’s Joint Steering Committee or JSC made the following observations. First, the safety profile was consistent with prior clinical trials of imetelstat in hematologic malignancies, and no new safety signals were identified. Second, outcome measures for efficacy including spleen volume responses and reductions in total symptom score remain consistent with the prior data reviews. Third, with a median follow up of approximately 19 months as of the January 2018 data cut, the median overall survival has not been reached in either dosing arm. Following the state of review, the JSC implemented a number of actions. First the trial is being officially closed to new patient enrollment. From the first enrolled patient in September of 2015…

Operator

Operator

[Operator Instructions] Our first question comes from Charles Duncan with Piper Jaffray. Your line is now open.

Charles Duncan

Analyst

So had a couple of questions, I’ll try to be quick. First of all with regards IMbark protocol amendment to allow patients to remain on drug following the primary efficacy analysis. Chip, I’m wondering if you could provide us a little bit more color. Is that really driven by some blinded clinical observations or you see it just as good practice. And can you provide any color on the number of patients that remain on drug out of the roughly 100 enrolled?

John Scarlett

Analyst

Well, first of all the amendment to continue to follow patients predominantly for survival is really mostly based on the - couple of things I’d say. First of all, it’s technically required because we were at the end of the specified treatment period in the original IMbark protocol that was begun quite a few years ago now. So in order to continue to follow patients, we just needed to amend the protocol get approved through ethics committees and so forth. So that’s really I would say the principal driver. And obviously the reason we wanted to do that is because we still have not seen median survival reached in either of the arms or either the original arms in the study. So we’d like to continue at least through that point of time. So that really dictates the protocol amendment predominantly one of timing. Sorry the second question that you had was?

Charles Duncan

Analyst

You probably can’t answer this, but in terms of the number of patients that remain on drug, do you have any information on that that you can provide?

John Scarlett

Analyst

No, we’ve not been giving those numbers as we’ve gone along and I think we’re going to continue to not to do so.

Charles Duncan

Analyst

And then you did nice job summarizing some recent reviews of what happens to patients post JAK inhibitors and what to expect there at least historically. And I guess I’m wondering when you consider the patient population of MF patients that have been on the JAK inhibitors in the trial, do you think that the sample is reflective of the broader patient population and if so could you help us understand are they all Jakafi post, Jakafi patients. Or are there some of the patients who been on JAK inhibitors in clinical trials other than Jakafi.

John Scarlett

Analyst

So, I do think that this population was quite similar to the broader patient population that comes from a couple of observations. First of all we had really no specified exact type of JAK inhibitor that was previously the patient’s had to have been previously exposed to. Obviously the vast majority of them were exposed to Jakafi itself to ruxolitinib, but we certainly had modest numbers of patients who had been exposed to other potential JAK inhibitors. I would call out particularly momelotinib, fedratinib, and pacritinib, I’m not sure the exact numbers. I would say probably the majority just because of when the timing of the study was momelotinib but there have been as far as I recall at least small numbers of pretty much - all of the investigational agents at one-time or another after patients had failed them. But the vast majority were actually - clearly post Jakafi or ruxolitinib.

Charles Duncan

Analyst

And last question is hopping over to IMerge. The update - I guess I’m wondering when would you anticipate a next update and could this perhaps be at or before Janssen continuation decision?

John Scarlett

Analyst

I think it’s unlikely - this is my own opinion and we haven’t - I don’t have a specific reason for saying it. But I think it unlikely that we’ll be giving any specific information between now and then. Obviously, we try to hold most of our data for scientific meetings and we’re still ways away from the typical meeting where this would go which would be ASH the end of the year. But I don’t really know, I mean we haven’t really discussed these precise plans for either publications of topline or revelation of topline data or for that matter other possible abstracts. So I don’t really know right now, I wouldn’t be holding my breath. So I think that this data is maturing very nicely and so let’s wait and see.

Operator

Operator

Our next question comes from Chad Messer with Needham and Company. Your line is now open.

Chad Messer

Analyst · Needham and Company. Your line is now open.

So for IMbark, it seems like the promise here is a drug for JAK failures that has potentially a good survival benefit, but perhaps not as much efficacy on some of the traditional efficacy parameters like spleen volume. Is that fair characterization of what the data telling us so far and if so does that make mechanistic sense?

John Scarlett

Analyst · Needham and Company. Your line is now open.

So it’s a very interesting and good question. I think one of the things that we pointed out in the past and I would point out again, is that when most people think about spleen volume response rates and for that matter, Total Symptoms Score reductions, they really hearken back to the original rather I thought impressive data shown by ruxolitinib in frontline patients and in fact not only in frontline patients but really the first patients to ever be exposed to JAK inhibitor in anyway shape or form. And you’ll recall that there was a fair amount of variability even there. The FCR in COMFORT-I which was the U.S.-based study was 42% in patients who were treated with ruxolitinib frontline remember again frontline. In COMFORT-II the European study that same basic population of patients, the FCR was 29%. And then I think the other thing to look at than is to say all right, well if we’re not in frontline which we are definitely not in frontline. We are in patients who are at the far end of the other part of that - of the spectrum. If you look at some of the - for example the momelotinib data not necessarily with regard to momelotinib but even with regard to the best available therapy arms, right. So in SIMPLIFY-2 the best available therapy are included 88% of those patients got ruxolitinib. Now these are patients who are second line exposed. And there they only had a 5.8% spleen volume reduction by the typical methodology. PERSIST-2 showed - had about half of the patients roughly had ruxolitinib treatment in their BAT arm and that was only 3%. So my point is really that when you take second line patients or in our case truly relapse refractory patients, I think looking at spleen volume response rates and trying to judge those against first time ever exposed to JAK patients very early on relatively early on in their treatment paradigm, I think you can be misled. So that’s why we’ve actually ended up looking predominantly at survival which is the ultimate outcome that everybody cares about. So I personally believe that patients would not be staying on drug if they were not getting benefit and I also think that if we are able to confirm significant survival benefit in these patients who really have no other alternatives that this will be potentially a very useful drug. How that plays out in a regulatory process and so forth, I’m not a 100% sure nobody is. But I do think that we should not overlook the relative value of other measures beyond spleen volume response. And especially in drugs that are not really designed specifically to reduce the products of the disease that are thought to be related to spleen volume increase.

Operator

Operator

Our next question comes from Alex Schwartz with Stifel. Your line is now of open.

Alex Schwartz

Analyst · Stifel. Your line is now of open.

So the first question I had, can you talk more about the 4.7 mg/kg arm and if these patients remained on that dose the entire time or was the proposed Janssen protocol moment accepted and at what months did these patients crossover to higher dosing?

John Scarlett

Analyst · Stifel. Your line is now of open.

So there are patients who remained in 4.7 milligram per kilogram arm and did not crossover to the 9.4. I don’t think we’ve ever actually given any specifics around that, but it was and I’m trying to remember exactly when we implemented those protocol changes.

Olivia Bloom

Analyst · Stifel. Your line is now of open.

It was in October 2016, that’s when we did that first - Janssen did the first data review and it was at that time determined that the low dose arm, the 4.7 mg/kg didn’t warrant further investigation. So, patient enrollment in that arm was closed, a protocol amendment was processed at that time giving the investigators the option, whether to leave their 4.7 patients on that arm or they could dose escalate to 9.4 that was based on investigator choice.

John Scarlett

Analyst · Stifel. Your line is now of open.

So that was at the end of - towards the end of 2016 and that’s when some patients a dose escalated up to 9.4. But there were a meaningful number of patients who remained on 4.7. So did that answer your question?

Alex Schwartz

Analyst · Stifel. Your line is now of open.

Yes, it did. Thank you. And then a second question I had, kind of given the unmet need in MF patients after Jakafi and your OS data to-date and maybe a more permissive FDA. Any sense that you need to run a Phase 3 trial and what size might that be? Or rather the Phase 2 data that you have today and maybe 100 patients may be sufficient for FDA filing? Kind of any thoughts around that?

John Scarlett

Analyst · Stifel. Your line is now of open.

Well obviously, anything that I would say would be highly speculative. We’re still in the midst of a lot of development here. I’ll give you some general thoughts Alex about that. The first one is that I would say that, and you actually you actually prefaced the question with - some interesting prefaces, one of them was a more permissive FDA. I don’t know if that’s true or not, but I would say the following. Historically as I think everyone on the call probably knows, you need a control arm in order to make a correct and an appropriate scientific assessment of overall survival because you can be surprised by relative changes in patient populations and so forth. And so that’s historically been the regulatory standard would be to present OS data in the context of a control arm. We don’t have a control arm here, so that’s why we’ve been using historical data and have kind of upended the data - the literature in order to look for that. I don’t - I will say this, I think that you can make broad generalizations as we have here about what we’re seeing and how it compares to the literature which is now fairly consistent 14 to 16 months appears to be the median OS for patients in a number of different follow up studies carefully done in academic centers in terms of median OS after failing or coming off of JAK inhibitors and predominantly ruxolitinib. So you can judge we haven’t - as you also prefaced we haven’t reached the median OS yet. How that will play out regulatorily will demand really some careful thought around the world and also probably some level of interaction with experts. At the moment, I don’t think we’re prepared to say what our plans are with regard to that whether there will be an NDA filed, whether there will - how that will actually go forward. We wouldn’t want to be getting out ahead of some of those discussions and we still kind of need to reach meeting OS, in order to really know where we are. So that’s where I would say, - things stand today.

Operator

Operator

Our next question comes from Philip Lee with Mangrove Partners. Your line is now open.

Philip Lee

Analyst · Mangrove Partners. Your line is now open.

I have two quick questions. The first is, when you enrolled the IMbark trial were there any minimum platelet counts necessary for the patient to enroll or is there any information you can give us regarding their platelet accounts?

John Scarlett

Analyst · Mangrove Partners. Your line is now open.

Yes, we required at least 75,000 platelets.

Philip Lee

Analyst · Mangrove Partners. Your line is now open.

And my second question is, if you could give us any additional data regarding the ECOG Status? And how that’s stratified between 0, 1 and 2 at baseline for people enrolled in IMbark?

John Scarlett

Analyst · Mangrove Partners. Your line is now open.

We have not released that. That would be part of a publication, that’s usually not something that’s focused on as much in this field. So even though, I appreciate your interest in the subject. So we haven’t really given that.

Operator

Operator

Thank you. This concludes our question-and-answer session for today. So I’d like to turn the conference back over to Anna Krassowska.

Anna Krassowska

Analyst

Thank you everyone for joining us this morning. I just wanted to make a note that we will be attending the Needham Healthcare Conference next week on March 27. So maybe we’ll see some of you there and we will be giving a webcast presentation. So, thank you all.

Operator

Operator

Thank you. Ladies and gentlemen that does conclude today’s conference. Thank you very much for your participation. You may all disconnect. Have a wonderful day.