Geron Corporation (GERN) Q3 2013 Earnings Report, Transcript and Summary

Good day, ladies and gentlemen, and welcome to the Geron Corporation Third Quarter 2013 Earnings Conference Call. [Operator Instructions] As a reminder, this call may be recorded. I would now like to introduce your host for today's conference Anna, Head of Investor Relations. Ma'am, you may begin.

Thank you, Samia. Good afternoon, everyone and thank you for joining us for the Third Quarter 2013 Geron's Earnings Call. With me today are Dr. John Scarlett, our President and Chief Executive Officer; Olivia Bloom, our Senior Vice President, Finance and Chief Financial Officer; and Craig Parker, Senior Vice President, Corporate Development. This afternoon, we issued a press release that reported results for the third quarter ended September 30, 2013. 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 until December 8. Before we begin, please note that except for statements of historical facts, 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 timelines, prospects and plans for imetelstat, including anticipated timelines for clinical study initiation, clinical results and data, the therapeutic potential and safety of imetelstat, and financial or operational projections or requirements, including spending guidance. These statements may involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. With respect to the ASH abstract, it includes only certain preliminary safety and efficacy data, selected and interpreted by the investigator. And at the ASH Annual Meeting, we expect that additional and updated data will be presented. Because the additional and updated data may be materially different from the preliminary data in the abstract, the preliminary data should be considered carefully and with caution. Additional information concerning factors that could cause actual results to differ materially from those in the forward-looking statements is contained in Geron's periodic reports filed with the Securities and Exchange Commission under the headings Management's Discussion and Analysis of Financial Conditions and Results of Operations, and Risk Factors, most importantly, Geron's quarterly report on Form 10-Q for the quarter ended September 30, 2013, which was filed today. 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 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. So we will begin today's call with a summary of the third quarter operating results from Olivia, and then Chip will review the recent events. Olivia?

Thanks, Anna. Good afternoon, everyone. For the third quarter of 2013, the company reported a net loss of $8.3 million, or $0.06 per share, compared to $16 million, or $0.13 per share, for the comparable 2012 period. Net loss for the first 9 months of 2013 was $29.1 million, or $0.23 per share, compared to $53 million, or $0.42 per share, for the comparable 2012 period. Revenues for the third quarter of 2013 were $181,000 compared to $636,000 for the comparable 2012 period. Revenues for the first 9 months of 2013 were $1.1 million compared to $2 million for the comparable 2012 period. The decrease in revenues for the 3-month and 9-month periods ending September 30, 2013, compared to the same periods in 2012, primarily reflects the recognition of a license payment from GE Healthcare in the third quarter of 2012, and termination of our license agreement with Asia Biotech Corporation in December 2012. The license agreement with GE Healthcare was transferred to Asterias Biotherapeutics, Inc. upon the closing of the divestiture of the stem cell assets. Total operating expenses for the third quarter of 2013 were $8.9 million, compared to $16.5 million for the comparable 2012 period. Research & development expenses for the third quarter of 2013 were $5.3 million, compared to $11.7 million for the comparable 2012 period. General and administrative expenses for the third quarter of 2013 were $3.5 million compared to $4.8 million for the comparable 2012 period. Operating expenses for the third quarter of 2013 also included restructuring charges of $116,000. Total operating expenses for the first 9 months of 2013 were $30.7 million compared to $55.3 million for the comparable 2012 period. Research and development expenses for the first 9 months of 2013 were $18.1 million compared to $39.6 million for the comparable 2012 period. General and administrative expenses for the first 9 months of 2013 were $11.6 million compared to $15.7 million for the comparable 2012 period. Operating expenses for the first 9 months of 2013 also included restructuring charges of $1 million. The decrease in research and development expenses for the 3-month and 9-month periods ending September 30, 2013, compared to the same period in 2012, primarily reflects reduced personnel-related costs resulting from recent restructurings, lower manufacturing cost for drug products, and reduced clinical trial expenses in connection with the wind down of the imetelstat trials in metastatic breast cancer and advanced non-small cell lung cancer and GRN1005 trials in patients with brain metastases. The decrease in general and administrative expenses for the 3-month and 9-month periods ending September 30, 2013, compared to the same periods in 2012, primarily reflects reduced personnel-related costs resulting from recent restructurings, lower costs for consulting services and reduced costs for legal services associated with the company's patent portfolio. The restructuring charges incurred in 2013 reflect costs associated with decisions in April to discontinue our discovery research programs and companion diagnostics programs based on telomere length, as well as close our research lab facility and reduce our workforce. Interest and other income for the third quarter of 2013 amounted to $699,000 compared to $140,000 for the comparable 2012 period. Interest and other income for the first 9 months of 2013 were $836,000 compared to $481,000 for the comparable 2012 period. The increase in interest and other income for the 3-month and 9-month periods ending September 30, 2013, compared to the same periods in 2012, primarily reflects a net gain on the sale of excess lab equipment related to the closure of our research lab facility, which was partially offset by a decline in interest income due to lower cash and investment balances in 2013. We ended the third quarter of 2013 with $60 million -- $67 million in cash and investments, and we have not incurred any impairment charges on our investment portfolio. I will now turn the call over to Chip.

Thanks, Olivia. Good afternoon, everyone. Most of you are aware or have seen that the abstract selected for presentation at ASH were made available to the public this morning. Among these was an abstract submitted in August of 2013 by Dr. Ayalew Tefferi containing certain of his preliminary data from his ongoing investigator-sponsored trial of imetelstat in patients with myelofibrosis which is being conducted at Mayo Clinic. Data from the IST is maturing and evolving on an ongoing basis. We expect Dr. Tefferi's presentation of this abstract at the ASH Annual Meeting to include additional and updated safety and efficacy data from this study. The oral presentation is scheduled to occur during the session entitled Myeloproliferative Syndromes: Clinical: Novel Therapeutic Strategies, which will take place on Monday, December 9, 2013, at 4:45 p.m. Central Time. To comply with the strict embargo policy, stipulated by the American Society of Hematology and to afford Dr. Tefferi the opportunity to present his findings in an appropriate clinical form, we are not able to provide any commentary about these data before his oral presentation at ASH. For those of you on the call who are not as familiar with this study, Dr. Tefferi's IST was initiated to evaluate the safety and efficacy of imetelstat in patients with MF and to determine an appropriate dose and schedule for further evaluation. The trial is an open label study in patients with primary MF, post-essential thrombocythemia MF, and/or post-polycythemia vera MF. And these patients all have intermediate-2 or high-risk disease as defined DIPSS Plus. The primary endpoint is overall response rate, which is defined by the proportion of patients who are classified as responders, which means that they have achieved either a clinical improvement, or CI, a partial remission, or PR, or complete remission, or CR, consistent with the criteria of the 2013 IWG-MRT. Secondary endpoints include reduction of spleen size, improvement in anemia, inducement of red blood cell transfusion independence, safety and tolerability. In the initial cohort of patients in the IST, Cohort A, imetelstat was given once every 3 weeks. In the second cohort of patients, Cohort B, imetelstat was given weekly for 4 weeks, followed by 1 dose every 3 weeks. In addition to Cohorts A and B, Dr. Tefferi has informed us that enrollment has commenced in additional cohorts of patients with MF to evaluate the safety and efficacy of imetelstat using different dosing algorithms. Based on his experience with imetelstat in the initial patients with MF, Dr. Tefferi is also interested in evaluating imetelstat in different patient populations. As we previously disclosed, he's initiated enrollment of a cohort of patients with MF that has transformed into AML known as blast-phase MF. He's also commenced enrollment of a cohort of patients with certain subpopulation of MDS. Dr. Teferri has informed us that he has enrolled more than 50 patients across all of these cohorts since the IST was initiated in November 2012. We believe that diseases such as MF, and possibly AML and MDS, represent the greatest value-creating opportunity for Geron because many patients have significant unmet medical needs, and unlike existing therapies, we believe imetelstat has the potential to address the underlying neoplasm. We plan to move forward with further development of imetelstat in MF. Pending additional input from regulators, investigators and other experts, as well as further insight from the additional and updated safety and efficacy data to be presented at ASH, we expect to initiate a Geron-sponsored multi-center trial with imetelstat in the first half of 2014. In the first quarter of next year, we expect to give guidance regarding the key endpoints, scope, design and timing for this Geron-sponsored study in MF, as well as further elaboration on the development and registration plan for imetelstat in this indication. With that operator, let's open the call to questions, please.

[Operator Instructions] Our first question comes from Charles Duncan of Piper Jaffray.

I wanted to -- I know that you're not going to able to say much about the data than anything that you've already said. But I am wondering if you have a perspective on the types of patients enrolled in the study; high and intermediate-2 risk myelofibrosis patients. If you will, are these garden-variety patients, or were they specifically selected by the investigators for this study?

You're right. We're not going to able to comment on anything. The ASH embargo is really straightforward. We're not able to make any commentary on the subject of the abstract which this question -- your question implies. I would just simply say that there -- as we said before, they're DIPSS intermediate-2 and high risk, but beyond that, we're not able to say anything. Sorry.

Okay. I understand, Chip. The other question I have, which is maybe a more global question, is regarding the IWG criteria. And that is, do you know if there's a way to modify the way that you look at CR, PR, and focus just on bone marrow peripheral blood morphology for patients and forget about clinical improvement? Or do you have to consider that, and was that an important consideration in these data?

Well, I'm not going to talk about the considerations in these data, but what I can say is that the IWG criteria for myelofibrosis is pretty clear. It's quite clear that CRs and PRs are intended to signify a disease modification and to achieve a CR, PR, clearly, you have to achieve other components of the response, the remission beyond pure bone marrow morphology, et cetera. So these are found in the blood paper in 2013 and include resolution of symptoms, spleen and liver not being palpable, and so forth. So I would just refer everyone to that paper.

Our next question comes from Cory Kasimov of JPMorgan. Matthew J. Lowe - JP Morgan Chase & Co, Research Division: It's actually Matthew Lowe in for Cory today. I guess just wondering if you could comment, from a more theoretical standpoint, that -- I mean, is it possible that symptom improvement with the drug could lag the bone marrow and blood effects and maybe presented at a later point in time? Do you see that as something which is feasible?

Well, from a theoretical perspective, as you quite rightly pointed out, not commenting on any data contained within the abstract. The -- I think that if you see -- look, the goal is obviously having meaningful disease modification, and as far as we know, the symptoms are associated with cytokines that come from, presumably, from the underlying malignant progenitor cell neoplasm. So theoretically, one should expect, I would think, to see changes in all of these different criteria that make up the response criteria, the IWG response criteria, at some point. The exact nature of how long it takes and so forth may be both individualized, and also, I don't think that we can make any further comments about that without breaking the embargo. But I would just simply say that, theoretically, one should expect to see things. If you get the underlying neoplasm headed in the right direction, I would expect most of these criteria to head in the right direction. Matthew J. Lowe - JP Morgan Chase & Co, Research Division: Okay. And then just as a quick follow-up. With the responses that are referred to in the abstract this morning, I mean, I guess, what is the definition of those responses? Are they according to the criteria that you mentioned? Or are they just kind of referring to responses specifically to do with the bone marrow and the blood?

I think I'm going to have to let you read the abstract for yourself and interpret it that way. I'm not going to be able to make any comments about that, sorry.

Our next question comes from Brian Klein of Stifel. Brian Klein - Stifel, Nicolaus & Co., Inc., Research Division: Just a couple of financial questions. On the quarter, it looks like you spent a little over $5 million on R&D, just wondering if you can provide some color on where that spend is going beyond just supporting the IST program?

This is Olivia. So I would say that R&D expense, as we've noted in the Q, so I would definitely point you there first, is comprised of a number of categories, and those include, not only direct external costs that are in support of our clinical program for imetelstat, but also personnel-related expenses, as well as other R&D cost that would reflect maintenance, the building depreciation and other costs. Brian Klein - Stifel, Nicolaus & Co., Inc., Research Division: Okay. If that's the case, how much of that is actually going to direct imetelstat development, if you could provide a number?

So just the external imetelstat clinical program costs are approximately $1.9 million, of the $5 million. And I would point -- which is approximately 36%. So I would point you to the MD&A in the Q that has a table that would give you the specifics of the clinical program costs, as well as the personnel-related and other R&D expenses that I just mentioned. Brian Klein - Stifel, Nicolaus & Co., Inc., Research Division: Great. And then just 1 follow up here. I know you haven't fully fleshed out the proposed Phase II program for imetelstat, but could you give us maybe a range of what you might expect a Phase II program to cost?

Well, because there are many details and many variations within a particular trial design and scope, it would be difficult for me to even probably give you a range without being potentially inaccurate. So I would want to just refrain until we have that design and scope, as Chip identified, which will be in the first quarter of next year.

Our next question comes from Ryan Martins of Lazard Capital Markets.

Just wanted to ask, you said that Dr. Tefferi's going to have another additional cohort of patients that he's going to enroll. Do you have an idea of what dosing schedule he's considering for that cohort?

We're not commenting today on any of the additional cohorts other than the identification of the blast-phase MF patients and the other MDS cohorts. So we're really not commenting any further today on that. So I'm not going to be able to make too many comments about that, Ryan, sorry.

Okay. Just -- I don't know if you can talk about this, but on the complete responses -- complete remissions in the abstract, it was not clear, from reading it, if they had met the minimum 12-week duration. Was that the case or not?

I think you're going to have to read the abstract again for yourself and put that through the -- because I'm just not going to able to comment on the abstract as we've said a couple of times on the call, sorry.

Okay. And in terms of prior reporting of the data, we had seen some elevations of liver function tests, alkaline phosphatase, low-grade. There was no mention of any of these in the abstract. Is this something that was not seen, or is this something that we just have to wait for the presentation in order to find out?

I think I invite you to come to the ASH abstract presentation. I don't know if that will be part of it or not, but we certainly can't comment today.

Our next question comes from George Zavoico of MLV & Co. George B. Zavoico - MLV & Co LLC, Research Division: One question I have about -- that maybe you can, maybe you can't, answer it is whether you or Tefferi are looking to see if there's a correlation between response and telomere length in that study? Or are you just going to reveal that at ASH?

Yes. I think that, again, that's clearly within the 4 corners of the study, and I would point you back to the abstract in that regard. Sorry, George. George B. Zavoico - MLV & Co LLC, Research Division: Okay. Not a problem, I understand. And regarding -- and the other trial you have ongoing, since we can't talk about myelofibrosis, of course. What's going on with the essential thrombocytopenia -- thrombocythemia program? Those patients are still on trial, many of them, aren't they? And do you expect to update us at all on the progress of those patients in the near future?

I would expect to do that through an abstract presented at an appropriate scientific meeting, which is the usual way we do it and most companies do. It is still ongoing and I have nothing to report today. But it is still ongoing.

Our next question comes from Charles Duncan of Piper Jaffray.

This is Roy in for Charles. A couple more broad questions, I guess. The first one, I just want to know if you guys have any initiatives that you can discuss to potentially improve the dosing convenience of imetelstat?

We don't have anything that we discuss today. Thank you for asking, but we don't have anything we can discuss today.

Okay. And could you discuss possibly -- I guess, I'm not really familiar with this, but generally, the importance of splices on mutations in this space. If you could...

Yes, unfortunately that is covered within the 4 corners of the abstract, and that's a part of the embargo. So I think you'll have to wait for additional information once the embargo is off.

And our final question comes from Ryan Martins of Lazard Capital Markets.

Chip, I was just going through the Q, there's a mention there about other company verifying information generated by the investigator. Is it -- can you confirm at this point if the information that's in the abstract as released has been verified by the company?

Sorry, same answer. Can't comment. Embargo, et cetera, on anything to do with the abstract. So I'm sorry, Ryan.

And we do have a question from Billy Teran[ph] of CBT Enterprises[ph].

This question might be naive, but is there a relationship between success rate and blood type, or don't you check them at all?

I'm unfamiliar with any correlation between different blood types and either the occurrence or the history of myelofibrosis, Billy. So I don't know of any relationship there or with any relationship between blood type and the type of response one would get in general in this disease.

Let me ask you a question. Shouldn't we look at it?

I think we're going to not comment about that all. I appreciate your interest in it, but at the moment, that's not one of the criteria that are utilized in any of the IWG criteria, and we pretty much stick to them in general. It's something that we've commented on previously and wouldn't be commenting on it today.

Thank you. And at this time, I'd like to turn the call back to management for any further remarks.

Thanks very much. Sorry we're under the embargo and can't answer more questions. But we would be -- we look forward to seeing people at ASH. Thank you very much.

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