Geron Corp (GERN) 2012 Q3 法說會逐字稿

Good day, ladies and gentlemen, and welcome to your Q3 2012 Geron Earnings Conference Call. My name is Delu, and I will be your operator today. (Operator Instructions) As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Ms. Anna Krassowska, Head of Investor Relations. Please proceed, ma'am.

Thank you, Delu. Good afternoon, everyone, and thank you for joining us today for the Geron Third Quarter Earnings Call. With me on the call this afternoon are Dr. John Scarlett, President and Chief Executive Officer; Graham Cooper, Executive Vice President-Finance and Chief Financial Officer; and Dr. Steve Kelsey, Executive Vice President and Head of R&D, and Chief Medical Officer.

We will begin the call with a summary of the operating results for the quarter and nine months ended September 30, 2012. Our agenda then includes an update on our clinical programs from Chip Scarlett. Following that update, we will be pleased to take your questions. Today's call is being webcast live on Geron's website at www.geron.com, and will be available for replay until November 30.

I would like to remind listeners that except for statements of historical fact, the statements in this conference call are forward-looking statements under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These include, without limitation, statements regarding the timelines and plans for Geron's research and product candidates, including anticipated timelines for clinical trial enrollment, clinical trial results and data, and therapeutic potential of Geron's product candidates, financial or operational projections or requirements including spending guidance and the estimate of 2012 year-end cash and investment balance, and the potential divestiture of Geron's stem cell program. These statements involve risks and uncertainties that can cause actual statements to differ materially from those in such forward-looking statements.

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, including Exhibit 99.1 to Geron's current report on Form 8-K filed on October 9, 2012. Undue reliance should not be placed on forward-looking statements which speak only as of the date that 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. I will now hand over to Graham Cooper, our CFO, to cover the third quarter financial results.

Thank you, Anna, and good afternoon. For the third quarter of 2012, Geron reported a net loss of $16 million, or $0.13 per share compared to $19 million, or $0.16 per share for the comparable 2011 period. Net loss for the first nine months of 2012 was $53 million, or $0.42 per share compared to $65 million, or $0.52 per share for the comparable 2011 period.

Revenues were $636,000 in the third quarter of 2012 compared to $220,000 for the third quarter of 2011. Revenues for the first nine months of 2012 were approximately $2 million compared to $2.2 million for the comparable 2011 period.

Revenues for the third quarter and first nine months of 2012 and 2011 included funding from a collaboration agreement as well as royalty and licensing revenues under various agreements.

Total operating expenses for the third quarter of 2012 were $16.5 million compared to $20.2 million for the third quarter of 2011. Total operating expenses for the first nine months of 2012 were $55.3 million compared to $67.9 million for the comparable 2011 period.

R&D expenses for the 2012 third quarter was $11.7 million compared to $16.3 million during the same period in 2011. R&D expenses for the first nine months of 2012 were $36.9 million -- sorry, $39.6 million compared to $49.6 million for the comparable 2011 period.

Decrease in R&D expenses for the three- and nine-month periods ended September 30, 2012 compared to the same period in 2011, primarily reflected lower expenses for personnel-related costs and scientific supplies resulting from the discontinuation of Geron's stem cell program.

G&A expenses for the third quarter of 2012 were $4.8 million compared to $3.8 million during the same period in 2011. G&A expenses for the first nine months of 2012 were $15.7 million compared to $18.3 million for the comparable 2011 period.

The increase in G&A expenses for the third quarter of 2012 compared to the same period in 2011 primarily reflected higher legal and consulting fees associated with the Company's IP portfolio and stem cell divestiture efforts. The decrease in G&A expenses for the first nine months of the year compared to the same period in 2011 primarily reflected a decline in personnel-related expenses associated with a management transition in the prior year, and lower non-cash stock-based compensation expense.

Non-cash operating expenses, which primarily included stock-based compensation and expense for stock issued for services were approximately $2 million and $6.4 million for the third quarter and year-to-date 2012 period compared to $3.7 million and $19.3 million for the comparable 2011 period.

Interest and other income for the third quarter of 2012 amounted to $140,000 compared to $237,000 for the comparable 2011 period. Interest and other income for the first nine months of 2012 was $481,000 compared to $820,000 for the comparable 2011 period. A decline in interest and other income primarily reflected a decrease in cash and investment balance. The Company has not incurred any impairment charges on its investment portfolio.

We ended the quarter with approximately $107 million in cash and investments. We have given guidance of cash spend of approximately $65 million for 2012, and we continue to support that estimate. Therefore, we expect to have expect to have approximately $90 million in cash and investments at the end of the year.

With that, I would like to now hand the call over to Chip, to provide a brief update on our clinical development programs for imetelstat and GRN1005.

Thanks, Graham. Good afternoon, everyone, and to all the participants on the call from the Northeast, thank you for making the effort to join this call. We wish all of you well over the next days and weeks.

As you are aware, we announced last month that on the basis of an unplanned interim analysis, we discontinued our randomized Phase 2 study of the imetelstat in metastatic HER2-negative breast cancer. The study in non-small cell lung cancer is continuing, but because the prespecified criteria for success was not met in the overall analysis, we have no plans to conduct a Phase 3 study of imetelstat in non-small cell lung cancer.

Additional subgroup analyses that were called for in the protocol are ongoing, and we expect to publish the results of those analyses in a scientific forum at a later date.

Despite the disappointing data from the two solid tumor studies that we announced last month, our plans for further development of imetelstat in hematologic malignancies have not been adversely impacted. We still believe that telomerase is a relative target in hematologic tumors, and that imetelstat is an active inhibitor of that target. The hypotheses that we are testing in our hematologic malignancy studies remain valid because they are largely independent of those tests in the solid tumor program.

Specifically with regard to the imetelstat program in hematologic malignancies, an abstract reporting, the results of our Phase 2 study of imetelstat in ET has been selected for an oral presentation at the annual meeting of the American Society of Hematology, to be held this year in Atlanta. The presentation will be made in the session entitled Myeloproliferative Neoplasms - Novel Therapies, which is scheduled to take place on Sunday, December 9.

We are also continuing to develop our peptide drug conjugate, GRN1005 for use in brain metastases. A poster reporting interim efficacy and safety results from our GRABM-B trial of GRN1005 in patients with brain metastases from metastatic breast cancer will be presented at the San Antonio Breast Cancer Symposium on the evening of Thursday, December 6. This study continues to enroll with top line results expected from the completed study in the second quarter of 2013.

The GRABM-L study in patients with brain metastases from non-small cell lung cancer is enrolling slower than we had originally anticipated, primarily due to medical practice patterns that dictate the use of other chemotherapies in patients with progressive extracranial disease. Due to the enrollment challenges, we are currently reassessing whether to continue this study, and if it continues, the timeline for reporting top line data. So, this covers the update on our clinical programs today.

As Graham reported, we had $107 million in cash and investments at the end of the third quarter, and we expect to end the year with approximately $90 million. We clearly need to ensure that we make the most of that resource and are therefore currently engaged in a review of all of our programs to determine how we can maximize their value in the most cost-effective manner possible. Once we have completed that review, which we intend to do before the end of this year, we will communicate the details to you.

I would also like to give you an update on several recent additions to our management team and to our Board of Directors. In September, Dr. Andrew Grethlein joined the Company as Executive Vice President of Technical Operations. Andy oversees Geron's manufacturing and quality functions. He joins us from Inspiration Biopharmaceuticals, where he was chief operating officer, and prior to that he was at Ipsen as a senior vice president of biotechnology and the portfolio management team leader for hematology.

Also in September, Dr. Susan Molineaux and Mr. Dan Bradbury joined our Board of Directors. Susan has substantial experience as an oncology drug developer, particularly in translating cutting edge biology in the clinically relevant oncology drugs. She cofounded Proteolix and was responsible for leading the development of carfilzomib, which is now marketed as Krypolis by Onyx for the treatment of multiple myeloma.

Dan Bradbury was the CEO of Amylin from 2007 until the company was acquired earlier this year, and played a significant role in that company's success for the better part of two decades. Dan brings extensive executive leadership experience to our board based on his career of nearly 30 years in the biopharmaceutical industry.

With these additions, we continue to invest in the future of Geron. I believe the depth and experience of our management team and our board is second to none for a company of our size in this industry, and I look forward to working with them to build a successful oncology development program at Geron.

Before opening the call up to Q&A, I'd also like to provide a brief update regarding the potential divestiture of the stem cell program. As you may have seen, on October 18, BioTime issued an open letter to Geron's stockholders regarding our stem cell programs. In the letter, BioTime outlined a proposal for a series of transactions in which Geron would transfer its stem cell assets to a BioTime subsidiary. In exchange, Geron's shareholders would receive an ownership interest in that subsidiary, warrants to purchase shares in BioTime, and a potential mechanism to increase their ownership of the BioTime subsidiary through a future rights offering.

The transactions that BioTime has proposed are complex. We are currently working with BioTime in consultation with our legal and financial advisers to learn additional important details relating to their proposal in order to adequately assess its feasibility and desirability for our stockholders in the context of other potential outcomes for the divestiture of our stem cell business.

So, that concludes my remarks for the moment. Operator let's open the call to questions, please.

Thank you. (Operator Instructions) And the first question comes from the line of Ryan Martins, Lazard Capital. Please go ahead.

Hi, thanks for taking the questions. So, maybe the first question just on the, you know it's going to be at ASH, can you talk about how many patients we may see data on here? I know there is ET and there is also like PV patients, if we are going to see some data also on the PV patients. Maybe we can start with that and have other follow-ups.

Steve Kelsey will --

Yes, we have to wait. We'll wait until the abstract goes live before disclosing the number of patients, and there will be no data on patients with PV (inaudible).

Okay. And what is the last update in terms of enrollment that you had provided?

We haven't provided any information on that.

Okay. And just on the -- thinking about Phase 3, provided obviously the data, the data indicated plans for a Phase 3. Is this Phase 3 going to be a combo study or could it be a monotherapy, and what are your considerations with that? Because obviously with all the other agents available, and just wanted to get your thoughts on that.

Well, we've never disclosed any plans to move into Phase 3 in essential thrombocythemia. We've used the study as a catalyst to broaden the imetelstat program in hematologic malignancies, and we'll be disclosing our plans for moving forward in hematologic malignancies in the near future, but we will not be announcing plans to move into Phase 3 in essential thrombocythemia.

Okay. And just on the JAK2 mutation levels, I know you had mentioned you will assessing this. Is this going to be assessed initially when patients enter the study and then at 12 months, the certain time periods at which --

All of the patients have JAK2 allele burden measured prior to starting imetelstat, and it's then the protocol calls for repeat measurements at quarterly intervals.

Okay. And then maybe just a couple of questions on 1005 and I'll jump in the queue. On the intracranial responses that are being measured here, where does the FDA stand in terms of intracranial responses as an endpoint?

They have never had cause to opine with regards to the status of intracranial responses as an approvable endpoint. The two drugs that have been developed for brain metastases in the last decade have not used intracranial response as an endpoint. So, if a company has approached the FDA with questions about intracranial response rate as an approvable endpoint, that data has never been made public.

Okay. And then maybe one final one. Can you talk about the (inaudible) distribution of 1005 to the brain, was the result systemically?

I don't have very good information for you about the relative concentrations in tissues outside the brain versus inside the brain in humans. What I can tell you is that the doses and schedule that we're using in the Phase 2 program, the concentrations of 1005 inside the brain, and particularly in tumors inside the brain, is in double-digit micromolar concentrations, which is way in excess of what is required for antitumor activity.

Okay, thanks.

Thank you. The next question comes from the line of Brian Klein from Stifel Nicolaus. Please go ahead, sir.

Great. Thanks for taking my questions. Steve, maybe a first one for you. Can you maybe give us a hypothesis as to why you think imetelstat was unsuccessful in the solid tumor trials?

Well, let me give you two completely separate hypotheses, because I think it's important to distinguish what we did in breast cancer from what we did in lung cancer. In breast cancer we combined imetelstat with paclitaxel, and what we found was that the overlapping hematologic toxicity of imetelstat with paclitaxel resulted in a required reduction in the dose of paclitaxel.

The study was designed deliberately such that dose modification to paclitaxel were performed in accordance with the package insert, with a product label, and so the -- unfortunately, the additional hematologic toxicity of imetelstat resulted in too much of a reduction in the paclitaxel dose in that arm. And we believe that's why patients in the imetelstat arm had a shorter progression-free survival than in the comparator arm.

With regards to the non-small cell lung cancer study, I don't think we have formally declared that that study has failed, per se. What we have disclosed are two things -- firstly, that the overall analysis fails to meet the prespecified criteria for success, and that we would be unlikely, on the basis of the data we currently have, to be moving directly into a Phase 3 study. But as Chip has pointed out, firstly, there as a modest improvement in progression-free survival in the overall analysis and there are prespecified subgroup analyses ongoing, which are all based on different hypotheses.

The ones that we've talked about, I think, publicly in the past, one is the combination with bevacizumab, and also some of the biologic characteristics of the tumor which might predispose to sensitivity to imetelstat.

Great. Thanks. And maybe a question for Graham. Given your reevaluation of the ongoing clinical programs at Geron, can you give us a sense of where you expect R&D spend to go over the next, let's say six months?

Sure. Well, Brian, as you know, as Chip referenced on the call, we're going through a strategic review right now, so it would be premature to give guidance for 2013 or even the first part of 2013. I do expect that our burn rate will be going down in 2013, relative to 2012, but we'll provide guidance once we get through this process that we're undertaking.

Great, thanks. And then, lastly, for Chip, a question on BioTime and the stem cell program. I know that you can't really comment specifically, but the assets, the stem cell assets that you have have sort of been on the market for about a year or so. Can you give us a sense of how discussions have gone over the past year and if the BioTime open letter is sort of your first offer that you've received, or if there has been other potential parties that have been interested?

You know, Brian, I'm really sorry, but this area of confidentiality and a confidential process, I would just get in a whole heap of trouble if I made any comments about that. I'm sorry.

Okay. Thanks a lot.

Thank you. The next question is from the line of Karen Jay from JPMorgan. Please go ahead, ma'am.

Hi. Good afternoon, and thanks for taking our questions. This is Karen Jay for (inaudible). I just had a couple questions on 1005 first, for the brain cancer trial, with brain mets. The data at San Antonio, can you give us a little more color as to whether or not it will be efficacy-related for the first patients that were enrolled, or will it be mostly safety?

No, the focus of our presentation at San Antonio will be on efficacy.

Okay, thank you. And correct me if I'm wrong, I think that trial started really last December and you're maintaining your guidance. So, are you -- can you confirm that you are very close to fully enrolling the trial?

We cannot confirm that we're close to fully enrolling the trial, because at this stage it's not entirely clear what full enrollment of the trial actually means. We are certainly very close to enrolling the first tranche of patients in the study, which is why we chose to submit an abstract to San Antonio. But there is sort of a rolling series of questions, and I don't think we're close to being fully enrolled in that study. We still remain well on track to what we said we would do, which is have the top line data from the final, the sort of final top line results by middle of next year.

Okay. And then just on the 1005 trial with the lung cancer patients. Are you considering, instead of stopping the trial, changing the design to include other chemotherapeutic regimens?

We are considering a number of options and we actually have organized a meeting which will take place in the next few weeks, from which we will be able to make informed decisions in partnership with our lead investigators and advisers. So, I'll keep my (inaudible) until we've actually figured out what we're going to do.

Okay, thank you.

Thank you. The next question comes from the line of George Saboke from MLVN Company. Please go ahead, sir.

Hi. Thank you, and good afternoon. I have a question about the way the trials are running and regarding the measurement, or pre-measurement, as it were, of telomere length. It seems that some variability in the telomere length may influence the outcome of various patients in the trials that could influence the final results. I'm wondering what you learned about that and how that might be influencing the design for imetelstat.

So, George, just to frame your question, I think you are alluding to the fact that we have previously disclosed but one of the subgroup analyses in the lung cancer study and the breast cancer study was the analysis of outcome by preexisting telomere length -- tumor telomere length?

Yes.

And so if I understand your question correctly, you're asking about the robustness with which we can actually measure that?

That's part of the question, yeah.

Okay.

And is it -- I presume every patient gets measured?

Well, okay. So, firstly, when we started the study, we did pre-specify in the protocol that we would be looking at outcome by pre-study tumor telomere length, but we did not mandate that every patient who wished to enroll in the study submit a tumor sample. So, it turns out, as is traditional for these types of studies, that just over half of the patients in the lung cancer study had tissue for evaluation, and around two-thirds of the breast cancer patients had tissue for evaluation. So, that's the first sort of cut of the data.

The second thing is the method by which telomere length is traditionally measured. We were the first people to turn that assay into something that could be performed on formalin-fixed paraffin-embedded tumor tissue. Plenty of people have measured telomere length by a variety of techniques, but we actually turned the -- we set up a PCR-based assay that can measure it on formalin-fixed paraffin-embedded tissue. And, again, we presented that at the AACR earlier this year.

The assay, as a research grade assay, is reasonably robust. The coefficient of variation for the measurement of any individual patient's telomere length is probably 10% to 15% in either direction. And, of course, that will result -- for any given cutoff of telomere length will result in a misclassification of 10% to 15% of the patients. But we will -- we'll finish up the analyses and we'll be presenting the data to scientific meetings probably sometime next year.

And is the data that is a mean of the telomere length? I imagine among tumors (inaudible) --

Yes, it is. It's essentially an average of the length of all of the telomeres in all of the tumor cells that appear in the section that we're provided with.

I see, okay. You said that the data would be presented sometime next year?

Well, we haven't actually, to be honest, haven't actually decided when we're going to choose which meeting we're going to target. But it will almost certainly be sometime next year.

Yeah, I think that will be a very important piece of information. Next question regards the 1005. You're looking at obviously brain mets. What about moving -- now that the lung cancer trial might be a little bit in question, depending on how the outcome of the meeting coming up that you mentioned in a week or two. In that meeting, will you also consider, or at other meetings consider moving into other brain indications, glioma, for example?

Yes, we have had a number of ongoing discussions about moving the 1005 program into primary brain tumors. As you know, one of the Phase 1 studies with 1005 was performed in primary brain tumors. I think we've previously disclosed that we've had an ongoing dialogue with a number of people regarding moving that program into primary brain tumors. But the focus of our attention and the priority internally within Geron has hitherto been the brain metastases program.

And in that regard, moving into other indications, I imagine, Chip, it's going to be part of the discussion when you review the strategic review of all the programs. I mean, if you're talking about a strategic review, like I said, all the programs, you could, the spectrum of outcome could be keeping everything going as it is versus changing everything that's going on. Can you talk a little bit more about what the criteria might be for the strategic review? I know you probably won't be able to say very much more about it.

Sure. I mean, it's exactly what you would expect. We're looking at the opportunities from ultimately a commercial perspective and where the greatest opportunities lie, what the cost of development is, and what the cost to get the key investable milestones are. And then arraying that against our cost basis, our existing cost basis and a cost basis going forward. And the idea is to maximize our opportunity while minimizing our spend. And that's a well-trod path in our business. It's one that most companies go through at some point as their plans get informed by results and various opportunities. And so that's exactly what we're doing. And as soon as we have clarity around that, especially in light of the results that we announced on the solid tumor studies, we will come back to everybody and let you know exactly how we see the direction changing, if at all, and what we anticipate investing in. And what we would hope the appropriate -- not only the appropriate outcomes, but sort of the timing for those outcomes and the timing of the spend. (Inaudible).

(Inaudible) assets that might be available for in-licensing is on the table as well, right?

Well, everything is on the table, but I think at the moment we still see -- in general, we see we have a lot of opportunities with our existing assets that we've already invested substantially in. We have a lot of insight and knowledge, and we have an established set of programs. So, I think the first order of priority is to prioritize what we have and to make certain that we can get there with the existing cash.

Okay, thank you very much, Chip.

Thank you. The next question is from the line of Tony Richter, individual investor. Please go ahead.

Yes. Thank you for the opportunity, and I'm going to approach my remarks with kind of a disclaimer, and that is that I'm just a civilian investor. I've been an investor ever since it was $6 a share, basically about four years ago, and thus far I have accumulated 10,000 shares, which candidly I'm holding for my grandson's educational trust.

But there's a number of issues, again as a layperson, that I don't understand, and I wish that it could be clarified in lay terms via the website or what-have-you, and that is that your recent, I guess, joint venture, whatever you want to call it, about a couple of weeks ago, I think, was a Texas operation. Am I making myself clear on this?

Yes, go ahead. I think with ViaGen.

Yes, right. What is that? Why is that? What do you hope to achieve and accomplish, etc. Because I went to their website and I gather that they're, if I may, looking to promote the company in terms of shareholders, or whatever. Again, I feel awkward here, but I really would like to know straight answers as to what's going on and why it's going on, and what the end result is hoped to be.

Yes. So, I think what you're referring to is ViaGen, and --

Yes, sir.

And we made no announcements regarding ViaGen, but you will see an update in the 10-Q that we will be filing shortly. So, without making further comment about what's going on at ViaGen, just direct you to that filing, which will be in the next few days.

Well, again, that goes back to my original point, in that you're talking 10-Q, you're talking as per SEC regulations, etc., and if I may, isn't there some way, shape or form that this could be boiled down to simple laymen's terms?

Yes. I appreciate your point of view. This is something that is particular to being a public company, and we have to provide disclosure on the same basis to everybody at the same time. We haven't given any more disclosure on the ViaGen situation, and sorry we can't go into any further detail here. But you will see some further discussion of it in the 10-Q, and the 10-Q will be available at sec.gov.

And the reference to providing information, again, my shares are held through Chase, and I guess their holding company or what-have-you, how can I personally, and Anna knows my e-mail address, how can I personally get on the hit list? I mean, when everything went upside down about a month or so ago in terms of discontinuing the study, it was noted that the shareholders had been advised, or a letter to shareholders, or whichever. I didn't receive anything and I don't know what the process is. Perhaps I should talk to Chase and my broker, but isn't there, again, a simple way for me and individual investors to get time-sensitive information when it's announced?

This is Anna. Yes, we can add your e-mail address to our e-mail distribution list and you'll receive press releases in real time. When it comes to our quarterly reports that are filed with the SEC, you can sign up for an alert on our website, and then you'll get an e-mail immediately, as soon as our SEC filings are filed, and then you'll know everything in real time. Offline send me an e-mail and I'll make sure your e-mail address is added to our list, and give you instructions on how to sign up for these other alerts.

Well, you sent me an e-mail previously, Anna, and you sent me -- a couple sessions ago, and you sent me an annual report. And I called you, left a message in reference to this, what we were just discussing, this whatever is going on with this Texas operation. There was no acknowledgement, and I really would appreciate it if you or a member of your staff could correspond with me on that and any other investor who is seeking information as a shareholder.

Of course, we'll be certain to do that. Thank you very much.

One other point --

No, go ahead.

Excuse me. Okay. I don't -- I'm going to ask a question which again, as a layperson, I've got to -- as a shareholder I've got to ask. What is your relationship with Seeking Alpha?

We have no relationship whatsoever with Seeking Alpha.

So, you're not a pay-to-play kind of an operation or whatever?

Not at all. As far as I understand it, they're -- individuals submit articles, we have absolutely nothing to do with any of them. We find out about them exactly at the same time you do, or anyone else. So, it's a completely independent function which we have nothing to do with.

And is there any hope of having an open annual shareholders' meeting in person?

We are considering how to best address the questions that individuals, as you put it, civilian investors, have. That is under some discussion and I hope to have some things to talk about at some point in the future. But, yes, the answer is that is being -- there are a variety of different initiatives underway to help address some of the questions and types of comments that you have had today.

I really appreciate this opportunity. I don't mean to be critical. I don't mean to be negative, but, again, lastly, you're dealing [with as many stock as such], and I think there's a lot of us out there who really would like to see you succeed and have these questions as laypeople.

Understood. We are keenly aware of that, so thank you very much. And thank you for your comments today.

Thank you.

Thank you. Ladies and gentlemen, that concludes your question-and-answer session today. I would now like to turn the call over to Dr. John Scarlett for closing remarks.

Thanks, everyone, for joining us on the call today. We look forward to providing future updates as our plans develop. And, again, to those in the Northeast, our best wishes and thoughts are with you. Thanks. Bye-bye.

Thank you for your participation in today's conference. This concludes the presentation. You may now disconnect. Enjoy the rest of your day. Thank you.