Geron Corporation (GERN) Q1 2016 Earnings Report, Transcript and Summary

Good day, ladies and gentlemen. And welcome to the Geron First Quarter 2016 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] As a reminder, this call may be recorded. I'd now like to introduce your host for today's conference Anna Krassowska, Head of Investor Relations. Please go ahead.

Thank you, Christie. Good afternoon, everyone. And thank you for joining us for the Geron first quarter 2016 earnings call. With me this afternoon are Dr. John Scarlett, our President and Chief Executive Officer; and Ms. Olivia Bloom, our Executive Vice President of Finance and Chief Financial Officer. Today we issued a press release that reported results for the first quarter ended March 31, 2016. This release can be found on our website at geron.com. Today’s call is also being webcast live on our website and will be available for replay through June 6. 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 potential payments under the Janssen collaboration agreement. The timeline, milestones, prospects and plans for imetelstat, including patient enrollment and planned internal data reviews and analysis, the therapeutic potential and safety of imetelstat, Geron desire to diversify 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 that Imetelstat is safe and efficacious in multiple indications, regulatory agencies permit the clinical trials to begin or continue to proceed, clinical trials can proceed without delays due to slow enrollment or other factors and Geron will receive continuation milestone and royalty payments 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 March 31, 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 to reflect future information, events or circumstances. We will begin today’s call with a summary of the 2016 first quarter operating results from Olivia, and then Chip will review recent events and discuss the ongoing activities with Imetelstat clinical trials being conducted by Janssen. Olivia?

Thanks, Anna. Good afternoon. For the first quarter of 2016, we reported operating revenues of $749,000 and operating expenses of $9.8 million compared to $537,000 and $10 million, respectively, for the comparable 2015 period. Net loss for the first quarter of 2016 was $8.8 million or $0.06 per share, compared to $9.3 million, or $0.06 per share, for the comparable 2015 period. Revenues for the first quarter of 2016 and 2015 included royalty and license fee revenues under various non-imetelstat related agreements. Interest and other income for the first quarter of 2016 was $256,000 compared to $149,000 for the comparable 2015 period. Research and development expenses for the first quarter of 2016 and 2015 were each $5.0 million. R&D expenses in 2016 primarily reflected the net result of higher costs for our proportionate share of clinical development expenses under the imetelstat collaboration with Janssen, partially offset by lower personnel related expenses as a result of the March 2015 organizational resizing. General and administrative expenses for the first quarter of 2016 were $4.8 million compared to $4.6 million for the comparable 2015 period. The increase in G&A expenses primarily reflects the net result of higher non-cash stock-based compensation expense, partially offset by lower personnel related costs due to the March 2015 organizational resizing. In the first quarter of 2015, restructuring cost related to the March 2015 organizational resizing were $406,000. All actions associated with this resizing were completed at the end of 2015. As a result, no corresponding restructuring costs were incurred in the first quarter of 2016. We ended the first quarter of 2016 with $141.9 million in cash and investments. I will now turn the call over to Chip to review current company events. Chip?

Thanks, Olivia, good afternoon everyone and thanks for joining. I’ll begin with comments on the two large global imetelstat clinical studies that are being conducted by Janssen; the first study referred to as IMbark is a Phase 2 clinical trial in approximately 200 patients with the intermediate two and high risk mylofibrosis or MF, who are relapsed after or are refractory to treatment with one or more JAK-inhibitor's. The first patient in this study was dosed in September 2015. In the IMbark study, patients are initially assigned to receive one of two dozen regimens either 9.4 milligrams per kilogram or 4.7 milligrams per kilogram administered every three weeks. An internal review is planned by Janssen after approximately 20 patients in each of these two dozen arms has been followed for at least 12 weeks, in order to assess the initial safety and efficacy of each of the dosing arms. Based on current enrollment projections, we continue to expect Janssen to conduct its internal data review in the second half of 2016. During this internal review, patient enrollment will continue. Potential outcomes from this internal review include the following; if both doses show adequate activity and an acceptable safety profile, we expect Janssen to continue with enrollment in both arms until approximately 100 patients per dosing arm have been enrolled. If one of the doses does not show adequate activity or have acceptable safety, we expect that Janssen may stop enrollment in that arm. In the event that both arms do not have adequate activity or acceptable safety, we expect Janssen may select an alternative dose based on exposure response, efficacy and safety analysis. There are no pre-determined study stopping rules in the protocol based on the results from this internal review. However, one or more findings related to safety or lack of efficacy could result in stopping of the study. As a reminder, I note that the co-primary efficacy endpoints in this study are spleen response rate and symptom response rate. These rates are calculated based on the proportion of patients who achieve a greater than or equal to 35% reduction in spleen volume and a greater than 50% reduction in total symptom score at the week 24 visit. Given the internal reviews occurring after only a total of 40 patients have been treated for 12 weeks, this is such an early look at the preliminary data in the IMbark trial, there are no plans to publicly disclose the results of this internal review. However, we will disclose any significant change to the design in the study. After approximately 200 patients have been enrolled in either completed 24 weeks of treatment or dropped out prior to the 24 week visit in the IMbark study, we expect Janssen to perform a data cut in the second half of 2017, and thereafter to initiate the protocol specified primary analysis. The time for this primary analysis may vary based on numerous factors including the pace of patient enrollment in the study. Following completion of the protocol specified primary analysis of IMbark, Janssen must provide a decision whether they want to maintain their license rights under the collaboration agreement and continued development of imetelstat. The second study being conducted by Janssen referred to as IMerge is a Phase 2/3 clinical trial in approximately 200 patients with low and intermediate-1 risk myelodysplastic syndromes or MDS, who are relapsed after or are refractory treatment with an erythropoiesis stimulating agent or ESA. The first patient was dosed in January of this year. We expect the open label Phase 2 data from up to 30 patients in part one of IMerge will be available in the second half of 2016 for Janssen to conduct an internal review. During this internal review, no new patients will be enrolled into the study. The data from this internal review must support a positive assessment of the benefit risk profile of imetelstat in this patient population before proceeding to part two of the study, which would be a Phase 3 randomized placebo-controlled trial. The timing for this internal review is based on current enrollment projections for IMerge and as is the case for the internal review of the IMbark study, there are no plans to publicly disclose these preliminary data from the internal review. However, we will disclose if the study proceeds to part two with dosing of the first patient or any significant changes to study design. Janssen has reported to us that enrollment in both IMbark and IMerge continue to be on track. As of late April, a total of more than 110 sites are active cross multiple countries and continents in the two studies. We’re very encouraged by the caliber of investigators participating in the studies and feedback from them has been positive. Next, I’d like to acknowledge several recent imetelstat publications and scientific presentations. In March, clinical data were pre-published online in the Blood Cancer Journal that describes safety and efficacy results from patients with type of MDS, known as refractory anemia with ringed sideroblasts or MDS-RARS. And these were patients who were enrolled and treated with imetelstat, as part of the Mayo Clinic pilot study. These data were previously presented last December at the American Society of Hematology 2015 annual meeting and included nine patients enrolled in the study cohort, classified as having either by IPSS intermediate-1 or intermediate-2 risk disease. Six of nine or 67% of patients had prior treatment with ESA's. Three of the eight or 38% of the patients who were dependent on red blood cell transfusions at the study entry became transfusion independent, defined as not requiring transfusions release date weeks. The median duration of transfusion independence was 28 weeks. In April of this year, at the annual meeting of the American Association for Cancer Research or AACR there were two poster presentations describing imetelstat nonclinical data authored by Janssen scientists and academic collaborators. The first poster presentation reported positive results from in vitro imetelstat treatment of cell lines taken from patients with acute myeloid leukemia or AML, in combination with hypomethylating agents that are currently used for the treatment of AML. Previously presented data of mouse xenografts in human AML treated with imetelstat in combination with the chemotherapeutic agent showed similar results. These two studies together extend the rationale for the potential use of imetelstat in additional hematologic myeloid malignancies, such AML. The second poster presentation authored by one of the investigators of the completed ET study, together with Janssen scientists, described results from non-clinical studies that provide further evidence that imetelstat potential on-target mechanism of telomerase inhibition underlies the reduction in platelets observed in previously conducted imetelstat clinical trials. The non-clinical in translational research studies represented by these poster presentations at AACR highlight the wide-ranging work Janssen is conducting on behalf of imetelstat. We’re pleased of the level of commitments that Janssen has demonstrated imetelstat across all aspects of our collaboration. Before I close my prepared remarks, I'd like to provide a brief status update on our business development activities. As we've indicated since announcing our collaboration with Janssen, we’ve conducted a rigorous and comprehensive process to identify and evaluate the potential acquisition of new oncology products, programs or companies that we believe could potentially diversify our business, as well as to leverage the potential cash stream that could come from the successful development and commercialization of imetelstat. An ideal acquisition candidate would be a company that would possess either a platform technology or capability with outstanding signs behind it, which could be used to develop a pipeline of preclinical or early clinical stage products that we believe could improve shareholder value on a risk adjusted basis. We continue to conduct such a search and evaluation process, but are uncertain as to whether we will be able to identify and make such an acquisition. Well, thank you all for listening. I'd be pleased to answer questions in the time we have remaining. So with that operator, please open the call to questions.

[Operator Instructions] Our first question is from the line of Chad Messer with Needham. Your line is open.

Hi, this is Esther in for Chad. Thanks for taking my question. My first one is about the AML study, I guess looking ahead would you be studying imetelstat combination with hypomethylating agents or do you – is there any other trial design that you have in mind so far?

You know Esther, it’s a good question. So we’ve reported in the past that although monotherapy with imetelstat, single agent therapy has showing antileukemic effects, we've also reported previously that we believe that in such an explosive disease as AML that it would be necessary to use imetelstat in combination with some form of additional therapy, whether it would be a hypomethylating agent, which is sort of pointed to by this particular poster or whether it would be a different type of chemotherapy, certainly is not yet been determined. But we would expect that it would be in some form of the combination study.

Okay. And then, I have another question on the other assets that you are looking at. Are you still looking in oncology or hematology or have you brought in your search outside of that?

No, we’re still focused on oncology in general with if you will sort of a preference if there was a hematologic oncology focus, that would be ideal for us. Obviously we remain in what I call the regulatory flow if you will by being part of the collaboration with Janssen, so we learned quite a bit about how regulators are thinking about hematologic malignancies and drugs in that space, and of course we also see all the competitive work that's going on. So I think that, that makes a lot of sense. Broadly speaking, oncology remains the business of the company. So we haven't broadened it beyond that to the state at least.

Okay. Thank you.

Thank you. Our next question is from Charles Duncan of Piper Jaffray. Your line is open.

Hi, this is Jordan Santucci on for Charles Duncan. Congratulations on the progress this quarter. So looking to these 2/3 IMerge designs, how do you think the design from part one will kind of help and form the efficacy and safety dynamics that will take you into part two of the trial?

I’m really sorry, if you could ask the question again, we were having a lot of trouble hearing the actual question, sorry.

Can you hear me now?

Yeah, that’s better, thanks.

So looking at the trial designs for the Phase 2/3 IMerge study, how do you think those escalation portion part one will help in forming the efficacy and safety dynamics to proceed into part two of the trail?

Right, well I think that it’s like everything else, let me just give a quick background to it of course. Part of the challenge with MDS, which again we’ve talked about in the past, is that we had a relatively small cohort in Dr. Tefferi’s study, it was only nine patients as I recall. And we saw some pretty healthy responses which I recapped in the top – in the conference call script today, but we didn't really get very much in the way of dosing information, and I think before one would dive into a big Phase 3 study with multiple, several hundred patients, he would want to reconfirm that you were seeing the type of activity that Dr. Tefferi saw, but in a broader sense, and also that the dosing seem to be appropriate. So I think generally speaking, that's that goal and once we have some confidence that would come out of the part one, then we would presumably be in a position to go towards part two.

That’s very helpful. Thank you.

Sure.

Thank you. Our next question is from Roy Buchanan of Janney Montgomery. Your line is open.

Hi, thanks for taking the questions. Had one kind of spread on by the data that was presented by Janssen at AACR for AML, just curious, if you look at the telomerase levels in the cells, just curious if there was any work ongoing either by you guys or them for potential companion diagnostic, any thoughts around that?

Well, companion diagnostics are always something that I think anybody in the drug development business today would love to have, but there was also a – it’s a lot of, there's a lot of complications there. I'm not sure where for a variety of different reasons including both competitive and also scientific reasons, I'm not sure we’re quite prepared to talk about it in any detail. All I can say is that we would love to have the ability to consistently measure both expression levels and an activity levels of telomerase and do correlations with some of the results from some of these big studies. But as of today, I don't think we've taken any decisions per se on whether or not there would or would not be a companion diagnostic developed. That will probably really require a very careful dissection of how we feel the state of the essay is in an actual clinical setting and correlating those results to actual clinical results. So sort of stay tuned, but at the moment I don't think we have anything to further to disclose or discuss.

Okay. That makes sense. And then, I think we’ve probably discussed this before, but whatever you can say about maybe a potential value range for the asset or company that you’re looking to buy or in-license and if you could discuss a little bit what that would from you guys in terms of maybe financing in the future, I know you guys have a hefty cash balance, but what do you need to do and how do you look at financing that?

Yeah, it’s pretty hard to talk about it until you have a – until you actually have something that you want to acquire or transact a company, you want to transact with. So I think in general, we probably defer any discussions of what types of financing or what the price range would be et cetera, it's really premature. So it's a, you know it's really always, this always ends up as you know on a case-by-case basis with taking into account risk-benefit issues for everything from pricing to other type of financing you do, so that's just a plateway [ph] of saying don't know yet, so probably can't comment on it further.

Okay. It makes sense. Thank you.

Sure.

Thank you. Our next question is from Tahel Noel of Stifel. Your line is open.

Hi, good afternoon. It’s Tahel Noel for Tom Shrader from Stifel. Thank you for taking my question. So I would like to know, do you see the potential to earn any imetelstat related milestones this year? And if so, what would the timing look like?

The milestones for the most part relate to a variety of different development, and ultimately commercialization related things. And I think we don't – I don't anticipate that this year there would be any particular milestone that would be triggered, beyond that I don't think we're in a position to make too many other comments about such things.

Thank you for that. And I have an additional question regarding your AML data that was presented at AACR. So do you see the drug fitting into the AML landscape? Would the dosing need to be very different used by patient that can’t handle the conventional seven plus three regimen, or do you expect that drug would be used after seven plus three in patients that could handle the side effects?

Well it’s a great question, and I don't think we're in a position yet to really disclose exactly how we would see the drug being fit into the current AML treatment paradigm. What I can say is that the way that I think we think of imetelstat, here at Geron having many years of experience with it, is that it’s the kind of drug that does not have immediate action. There is a certain degree of – there is a certain degree of lag time just because of – assuming it's all working by the telomerase mechanism, which we believe would be the case. There is a certain amount of time that it takes before the drug really comes on board and has its effect. So that's one of the problems with AML, as you know. This can be an extraordinarily explosive disease with blast crisis and patients really unfortunately progress extremely rapidly. So that's the reason that I think we believe the combination therapy is necessary. But exactly how that would fit in probably requires both some additional work, you know potentially even in the laboratory to help us understand some of these dynamics, and of course some exploratory work in the clinic. So as of right now, unfortunately I don't have any better answer for you – to you, but thanks for the questions.

Thank you very much.

Sure.

Thank you. Our next question is from Thomas Yip of FBR & Company. Your line is open.

Hey guys, thank you for taking my questions. It looks like, you guys are just moving forward, until the internal reviews for the two trials in the second half of this year. First question that I have is related to the enrollment sites that you said, you have 110 sites activated as of April so far, just wondering if that is for both IMbark and IMerge? And if so, what percentage does that represent of total plant site that you have?

We haven’t actually given the specific number of sites that we're getting towards the end, and I think we’re really happy about that. To answer your first question, Thomas, yes that reflects the total number of sites for both studies. I actually don't know if there are – the exact number of sites that have both studies active there, but as far as I know it's really small. So these are somewhat different populations of investigators. And so I think this is – we’re getting towards the end at least of putting additional sites on as far as I know.

Okay, I mean that’s fair enough. You know, as you guys are approaching you know, kind of like the internal data review, so one would assume that patients are kind of ramping up to your target number already. I guess my next question looks forward a little bit, is regarding Janssen decision after, and IMbark [indiscernible], which I guess that could arrive in late 2017 to early 2018, can you remind us what the options are at that point, and what would be some key factors into your decision making process?

So I think you're asking, if I understood the question, I think you’re asking about once Janssen makes a continuation decision, which would be based on the primary analysis of the MS study, that the – that then we would have a opt-in, and I'll give you sort of the top line answer, and if you would like more I’m going to refer it this to Olivia.

Sure.

Who may want to take another crack at it, but basically what happens, the way it works is that once we get a continuation decision, we also get a full package of information that sort of summarizes all of the necessary information for us to be able to make some financial decisions because that’s effectively what happens. If we elect to fund – co-fund going forward, it’s 20% of the development effort for the US, which by the way usually means both US and European studies would not for example include studies in China or Japan, which have less utility in US based filings. We would cover 20% of that and we would also – and we would also cover 20% of the selling effort in the United States, which really kind of translates to sales reps, and we could either satisfy that requirement for that 20% by actually providing 20% of the sales reps or by simply paying for 20% of the Janssen sales reps. The reason that one would consider taking on these cost is because this would also, there would be some, a slight change in the milestones, but more importantly this would in effect buy up the royalty rate in a meaningful way. So it does come down to sort of what you think the financial benefits would be at that time based on the information that we have and we would take that under advisement. Do that answer your question, if not maybe we can take another crack at it.

Yeah, I mean that pretty much aligns what your key thinking process is, and it’s a good option to have. Thanks for taking my questions and looking forward to next quarter’s call.

Thank you very much, Thomas.

Thank you. Our next question is from Charles Duncan of Piper Jaffray. Your line is open.

Hi, this is Jordan again. Thank you for taking my second question. So, relative to your previous comments on the call about imetelstat telo [ph] mechanism and aggressive characteristics of the AML, why did you select AML over other hematologic imitation for pre-clinical studies? Was it new – other combination new agent that increased your confidence for imetelstat to demonstrate some sort of preclinical efficacy, as well as the rationale there? Thank you.

Alright. So, I think the best way to put it is that if you look across the myeloid hematologic malignancies, there are sort of what I would – I mean there's obviously, polycythemia vera and essential thromocytemia, we actually did a very beautiful study in ET. Those are somewhat less severe diseases at least from a survival perspective. And as you know, we’ve elected at least not to go forward with ET commercially for a variety of reasons. Then there is MF and the MDS, both of which are very serious diseases and all of those disorders can transform in a certain percentage of the population. So for example around 20% of the MF and 20% roughly of the MDS patients actually transformed to AML, and they’ve transformed to a particularly difficult to treat variant version of that, which we would call secondary or the second secondary AML, which has dreadful survival characteristics, so it’s really a natural for one in studying the myeloid hematologic malignancies to sort of go downstream and look at AML, and AML is a terrible disease. I think we all know that have relatively limited drug treatments and is quite a significant unmet medical need. So I think that’s the best way to look at it. And so it’s both the commercial and also a scientific and also a medical rationale for it.

Thank you. That’s very helpful.

Okay.

Thank you. And that does conclude our Q&A session for today. I would now like to turn the call back over to Dr. John Scarlett for any further remarks.

Well, thank you all very much for participating. Wish you all a good quarter, and listen or hear from many of you next quarter. Thank you, bye bye.

Ladies and gentlemen, thank you for participating in today’s conference. This does conclude today’s program. You may all disconnect. Everyone have a great day.