Good day, ladies and gentlemen and welcome to Geron’s Fourth Quarter and Year End 2018 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 maybe recorded. I would now like to introduce your host for today’s conference, Ms. Suzanne Messere, Head of Investor Relations. You may begin.

Thank you, Catherine, and good afternoon, everyone. Thank you for joining us for today’s conference call. I am joined today by Dr. John Scarlett, Geron’s Chairman and Chief Executive Officer; and Olivia Bloom, the Company’s Chief Financial Officer. After the market closed, we announced our fourth quarter and year end 2018 results via press release. It is available on our website under www.geron.com/investors. On the call today, management will discuss recent events, fourth quarter highlights, financial results, guidance and upcoming milestone before answering your questions. A live webcast of the call is also available on our website and will be archived for 30 days. Before we begin, please note that except for statements of historical fact, the statements during this conference call and question and answer are forward-looking statements made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These include, without limitation, statements regarding, the expectations, plans, timelines and prospects for the Imetelstat and Geron including without limitation that patients screening and enrollment for the Phase 3 portion of IMerge will begin by mid-year 2019, that IND and Imetelstat clinical development program will transfer to Geron by the end of the second and third quarters of 2019 respectively, that more mature data from the Phase 2 portion of IMerge will be available and submitted for presentation at a medical conference in 2019. That Geron will outline its decision regarding the potential for late-stage development of Imetelstat and relapsed/refractory myelofibrosis patients by the end of the third quarter of 2019, that the Company’s operating expenses will be between $65 million to $70 million in 2019 and other beliefs and plans, expectations and projections that are not historical facts constitute forward-looking statement. 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 risks and uncertainties related to timing of the transfer of the IND and Imetelstat clinical development program to Geron and the ability of Geron to commence the Phase 3 portion of IMerge by mid-year 2019 and to come to a decision regarding potential late-stage development in MF by the end of the third quarter of 2019. 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 SEC, under the heading Risk Factors, including Geron’s annual report on Form 10-K for the year ending December 31, 2018. 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. I will now turn the call over to Dr. John Scarlett, Geron’s Chairman and CEO. Chip?

Thanks, Suzanne. I would like to welcome everyone for our fourth quarter and year end 2018 conference call. On today’s call, Olivia will discuss fourth quarter and year end financials as well as 2019 projected guidance. I’ll then discuss our plan for 2019, which build on data announced at the ASH Annual Meeting last December. After that, we’ll open the call for questions. So, in 2018 after regaining the rights to Imetelstat, we put plans in place to advance Imetelstat development program towards potential approval and commercialization. Based on this plan, we expect 2019 to be a pivotal year for Geron. At a high level during 2019, we expect to complete the transfer of the imetelstat IND from Janssen to Geron, to begin the phase 3 trial in lower risk MDS and to evaluate potential late-stage development in myelofibrosis as well as evaluate other myeloid hematology-oncology indications for Imetelstat. To enable these activities this year we are recruiting a development team with robust hematology-oncology expertise. This began in mid-January with Israel Gutierrez who joined as Vice President of Pharmacovigilance and Safety. Israel has 20 years of experience in drug safety and medical affairs at Pharmacyclics, Exelixis, Genentech, Celgene and Permeon where he was a member of the hematology-oncology development teams. Israel’s responsibilities at Geron are to lead our clinical drug safety risk management and compliance efforts include product safety-related recommendations and decisions. At the end of January we announced that Aleksandra Rizo join the Company as Chief Medical Officer and as a member of the company's Executive Management Committee. Dr. Rizo will be responsible for directing Imetelstat’s clinical strategy including designing a product development plan for current and potential future indications. Functions under her oversight include clinical science, clinical operations, data management, biostatistics, clinical pharmacology, translational research and medical affairs.…

Thank you, Chip, and good afternoon, everyone. For the fourth quarter of 2018, we reported a net loss of $7.3 million or $0.04 per share, compared to $7.4 million or $0.05 per share for the comparable 2017 period. For 2018, we reported a net loss of $27 million or $0.15 per share compared to $27.9 million or $0.18 per share for 2017. Revenues for the fourth quarter of 2018 were $375,000 million compared to $191,000 for the comparable 2017 period. Revenues for 2018 and 2017 were each $1.1 million and included royalty and licensee fee revenues under various non-Imetelstat license agreements. We adopted a new revenue recognition accounting standard as of January 1, 2018 using the modified retrospective transition method. Revenue for 2018 is presented under the new accounting standard, but revenue for 2017 has not been adjusted and continues to be reported under accounting standards used historically. Therefore, there is a lack of comparability between the periods presented. However, we do not expect the adoption of the new revenue recognition accounting standard to have a material impact to our financial statements on an ongoing basis. Total operating expenses for the fourth quarter of 2018 were $10 million compared to $8 million for the comparable 2017 period. Total operating expenses for 2018 were $32.1 million compared to $30.2 million for 2017. Research and development expenses for the fourth quarter of 2018 were $5.1 million compared to $2.5 million for the comparable 2017 period. Research and development expenses for 2018 were $13.4 million compared to $11.0 million for 2017. The increase in research and development expenses for the fourth quarter and year-to-date 2018 periods compared to comparable 2017 periods. primarily reflects increases in Geron’s share of Imetelstat development costs under the former collaboration agreement with Janssen where our share increased from…

Thanks, Olivia. That’s great segue to our 2019 objective. Our first objective in 2019 is the transition of the Imetelstat program back to Geron. We’re on track for the IND transfer to take place by the end of the second quarter and for the transfer of the majority of the program by the end of the third quarter of 2019. We expect transfer of the manufacturing activities to be completed by the end of the third quarter of 2020. We’re diligently managing the transfer of the IND in order to enable the start of enrolment of the Phase 3 trial and lower-risk MDS by mid year. In order for us to complete the transfer we need to obtain clinical, regulatory, biometric and safety information from Janssen to create our own data basis in monitoring systems. In addition, Janssen needs to transfer all regulatory filings as well as preclinical CMC and vendor information. We’re also preparing clinical supplies and readying our internal processes and systems to ensure compliance study conduct for both of the ongoing Imetelstat Phase 2 clinical trials. Once the IND transfer has been completed, our next 2019 objective is to commence screening and enrolment for the Phase 3 clinical trial for Imetelstat and lower-risk MDS by mid-year. Data from the Phase 2 portion IMerge that were reported at ASH in December support our decision to move forward to the Phase 3. The ASH presentation December reported results from 38 patients enrolled in the Phase 2 portion of IMerge. All 38 eight patients were transfusion dependent with low or Intermediate-1 risk, non-del(5q) MDS who had relapsed or refractory to prior treatment within erythropoiesis stimulating agent and who were naïve to treatment with a hypomethylating agents or lenalidomide. The baseline – sorry, the median baseline transfusion burden was eight units…

Thank you. [Operator Instructions] Our first question comes from Chad Messer with Needham & Company. Your line is open.

Thanks. Good evening, and appreciate you taking my questions. Just a couple from me. First, on this more mature MDS data, you mentioned median transfusion independence wasn't reached and you kind a called out maybe we could get that. Wondering if you could discuss what -- what you think a good readout on that would be, and also anything else to look for in that more mature dataset? Any kind of subsets or any other analyses that we might keep our eye open for?

Sure. Thanks Chad. Well, I think first of all, the form of the analysis will be very similar to that which we did -- which was presented at ASH. That's pretty much a quite a comprehensive evaluation of any drug being developed in lower-risk MDS, I don’t think we’re going to really change from that. It will also offer the opportunity to do a comparison as in particular patients who were involved in the second cohort, who were enrolled in the second cohort continue to mature into the window of time that we expect to see potential efficacy outcomes. So, I think the main thing to be looking for are really of the efficacy outcomes which include not only median transfusion independence et cetera, but also eight-week TI, 24-week TI, HIE and other classical measurements. Of course, there will be an update on safety as well.

Okay. Thanks to that. And then, you talked about potentially exploring other indications, wondering if it were possible for you to expand on that a bit more. I know in the past Chip, we’ve discussed AML as a possibility on that list. Just allow me to hear thoughts on that or for any other particular myeloid malignancies for Imetelstat?

Sure. Well, as you know, we’ve actually seen activity in all of the myeloid hema-malignancies that have been studied. Although to more or less degree according to the size of the study et cetera, so we obviously presented ET and those results were in the back-to-back paper from Dr. Tefferi on MF in the drill in 2015. We’ve just talked about MDS and further follow on MF. So the other big indication that remains is, as we say, Chad, its AML. AML is a complex disease. It’s frankly difficult to treat. And so we will be doing some work for sure in assessing where a drug like Imetelstat with its mechanism of action might best be positioned within the treatment paradigm for AML. I don’t think we’re ready to discuss that yet or discuss the type of studies if any that might occur. But I think there is sufficient number of preclinical studies and other indications, as well as this sort of broad-brush activity in kissing-cousin myeloid hema-malignancies to sort of justify a deeper dive on that. I don’t really have a whole lot more to say about that. But I’d like to emphasize for everyone listening on the call that even though this is – that’s exciting and its interesting and potentially the value, really the first job of this team and our company is to get our Phase 3 lower-risk MDS clinical trial and up and running and then evaluating the potential MS strategy. Once we’ve achieved that we can turn our attention to these potential other Imetelstat indications and potentially other product candidates actually.

Great. Thanks for that, and absolutely understand what your job one is. We just had plenty of times since the ASH to discuss some of those other things. So I appreciate you getting down on the weave with me a little bit. Thanks.

Okay.

Thank you. And our next question comes from Julian Harrison with BTIG. Your line is open.

Hi. Julian on for Tom. Thanks for taking my questions. First off, just curious how we should be thinking about Imetelstat for myelofibrosis in the context of the Fedratinib NDA acceptance earlier this week?

Sure. Well, first of all, we kind of know about Fedratinib about what you do from reading publications et cetera and understanding some of its past history as well as some of the more recent data. I think the way I would put it is that it's a very – it’s a JAK inhibitor, very different mechanism of action. Most of the emphasis has been as you would expect on spleen volume reduction, total symptom score, presumably being driven by changes in cytokines associated with inhibition of the JAK-STAT pathway. So I think it’s probably best compared to Ruxolitinib. The only other thing I can say that I gleaned in reading those papers and I don't have any other inside information of any nature as to what in the submission et cetera, is to say that the -- I think that Imetelstat potential survival advantage still looks extremely attractive. And I think that there will likely be very different potential uses of these various products based on the different mechanisms of action. But beyond that until we see deeper into how the agency deals with it and perhaps any additional information coming out, I don’t think I had to lot more to say about that.

Okay. Got it. Thanks. That’s helpful. And for my last question, regarding the Phase 3 portion of IMerge, should we expect an interim readout? And if so when might that occur assuming enrolment starts by midyear?

Yes. Thank. No. I don't think you should expect an interim readout. We have a lot of confidence based on a couple of different elements of this – of the design of this study. And I’d kind of comment about that. The data from the Phase 2 which we just described is really awfully strong from our perspective. The phase 3 trial we use the same patient population, same efficacy endpoint and same dosing regimens of Phase 2. And it has a Phase 3 design, it’s based on interactions of Phase 3 regulators. So I don’t think we feel the need right now to do an interim analysis to check for how things are tracking or any of the usual reasons that one would do in interim analysis. So that’s not in our plan as it stands today.

Okay, great. Thanks very much.

Sure.

Thank you. And our next question comes from George Zavoico with B. Riley FBR. Your line is open.

Hi, everyone. Thanks for the update and everything. I have a question about Luspatercept, because it's possible that by the time your trial starts or soon maybe halfway through or partway through, Luspatercept might be approved and marketed. How do you see that perhaps interfering, if you will, in any way, with the conduct and execution of your Phase 3 trial?

George, as far I know, the Luspatercept -- I don’t think we expect Luspatercept approvals before we would start our Phase 3. I’m not even sure to be honest with you when or if the NDA’s been filed. I don’t think it’s been filed yet, but…

April 2019.

April 2019 is when it's been announced, I guess, that Celgene plans to file it. So I don't think that will interfere with our study, though presumably while reviewing both of the enrolments Luspatercept, even if it gets a very quick review et cetera, should not -- I would not expect it to be available during the bulk of that enrolment. I think secondarily the more important thing is that, at least so far from what we can see, the two drugs really are -- I don't know where they're aimed. I'm not going to speak for Celgene in that regard. But they seem to have a different profile. Obviously, they’ve a very different mechanisms of action, and I think our perspective is that the patient who we've certainly gotten plenty of in our phase 2 and expect plenty of in our phase 3, which will be higher transfusion burdened patients -- remember we had on average eight units per eight weeks of transfusion, pre-treatment transfusion burden, compared to a lower number, five, for Luspatercept Medalist trial. Clearly we're probably going to end up with a somewhat different patient population. So -- and by the way, on the other side, Luspatercept clinical, the safety profile was benign, and so I wouldn't be surprised to see clinicians being more interested in Luspatercept earlier, and maybe the patients who are more difficult to treat, we may end up getting those. Whatever the case may be, I see the two drugs -- we've always seen the two drugs sharing the market, and I don't see anything different to suggest that that won't be true in the future. I think we will have enthusiastic investigator support and patient support of phase 3.

Okay. That's great to hear. That's great to hear. And finally, for the IND, you mentioned about manufacturing. Is JAK inhibitor from Imetelstat and [indiscernible] pass over, too, or do you have to still make the stuff for -- make it for the phase 3 trial?

Yes, no, we have drug ready to go, obviously. The Imetelstat supply chain has been cranking away, and we do -- we are able to access drug made at Janssen. But we will need to bring that supply chain fully back under our control as part of the transition, and that's actually -- and then we have to make drug beyond that to support future uses and perhaps. So I think that the point to the story is that that's got a longer tail on the transition than some of the purely clinical and regulatory items. And that was always contemplated in the agreement that we had with Janssen, so this is really just a reflection of what we anticipated in the event that Janssen did not continue development. And that's pretty much going according to plan.

Okay. Thanks very much, Chip and Olivia.

And thanks, George, for participating. I appreciate it.

Thank you. And I'm showing no further questions at this time. I'd like to turn the call back to Dr. Scarlett for any closing remarks.

Thanks, everybody, for joining us today. And we look forward to sharing the achievement of several objectives throughout the coming year with you. Thanks a lot, and have a good day. Bye.

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