Good morning everyone. Welcome to the Geron Corporation Third Quarter 2022 Conference Call. I’m Aron Feingold, Geron’s Vice President of Investor Relations and Corporate Communications. I’m joined today by the following members of Geron’s management team, Dr. John Scarlett, Chairman and Chief Executive Officer; Olivia Bloom, Executive Vice President of Finance and Chief Financial Officer and Treasurer; Dr. Faye Feller, Executive Vice President and Chief Medical Officer; and Anil Kapur, Executive Vice President of Corporate Strategy and Chief Commercial Officer. Before we begin, please note that during the course of this presentation and question-and-answer session, we will be making forward-looking statements regarding future events, performance, plans, expectations and other projections, including those relating to the therapeutic potential and potential regulatory approval of imetelstat, anticipated clinical and commercial events and related timelines, the sufficiency of Geron’s financial resources and other statements that are not historical facts. Actual events or results could differ materially. Therefore, I refer you to the discussion under the heading Risk Factors in Geron’s quarterly report on Form 10-Q for the quarter ended June 30, 2022, which identifies important factors that could cause actual results to differ materially from those contained in the forward-looking statements. Geron undertakes no duty or obligation to update our forward-looking statements. And now, I will turn the call over to CEO, Dr. Scarlett. Chip.

Thanks, Aaron. Good morning, everyone. Thanks for joining us today. Throughout the year, we have highlighted our vision for Geron, which is to become a leader in the treatment of hematologic malignancies. The strategic pathway to achieving this goal is defined by our expected journey to develop and commercialize imetelstat. Based on the imetelstat Phase 2 data and lower risk MDS, and in relapse and refractory myelofibrosis, we believe imetelstat has a highly differentiated compelling clinical profile. First, as a telomerase inhibitor, imetelstat has a unique mechanism of action that strikes at the very heart of these malignancies by targeting the malignant stem and progenitor cells that drives both lower risk MDS and JAKi relapsed and refractory MF. Second, the Phase 2 data also provided strong evidence for disease modification. At a molecular level, in both Phase 2 studies, we reported depletion of mutated and cytogenetically abnormal malignant cells that have been correlated with the direct clinical benefits of imetelstat, providing additional evidence of disease modification. Imetelstat is potential for disease modification not only differentiates it from other currently available therapies, but also directly addresses critical unmet needs in lower risk MDS and relapsed refractory MF, which we expect will provide a needed treatment option for patients with these diseases. Third, in both lower risk MDS and relapsed refractory MF patients treated with imetelstat, we saw unprecedented durability of clinical effects. For instance, Faye will describe an ASH abstract published today, in which we reported the approximately one-third of the 38 patients in our Phase 2 lower risk MDS study, who despite a median pretreatment transfusion burden of six RBC units for eight weeks experienced one year or more of transfusion independence. Similarly, in our Phase 2 relapsed refractory MF study, median overall survival for patients improved almost twice as…

Thank you Chip, John and good morning to everyone on the call. We at Geron are credibly excited that the top-line results of the IMerge Phase 3 study in lower risk MDS are just two months away. The clinical team has been actively preparing for the readout in accordance with industry best practices. The clinical cutoff for the top-line results occurred last month, which protocol is one year following the first dosing of the last patient randomized in the study. We have been continuing database cleaning activities on monitoring visits with our clinical sites in preparation for database lock, which is expected to occur before the end of the year. In early January 2023, we expect to deliver to Phase 3 IMerge top-line results, which will comprise a robust package of data that we believe will highlight the differentiating qualities of imetelstat. We anticipate sharing data on the primary endpoint of eight week transfusion independence, or TI, as well as key secondary endpoints of 24 week TI, and hematologic improvement-erythroid, or HIE, which is a composite measure of the percentage of patients who experienced an increase in hemoglobin and/or a reduction in their transfusion burden. We also plan to provide safety data in order to give a balanced benefit risk profile of imetelstat in lower risk MDS. As is typical for a Phase 3 trial, top-line results represent only a portion of the full clinical study readout. And we anticipate to present more comprehensive results at a future medical meeting. We expect the later additional data will include information on molecular indicators of disease modification, such as mutational burden reductions and an effect on cytogenetic abnormalities. The Phase 3 IMerge trial design matches many of the elements of Phase 2, including clinical site locations and investigators, patient population and enrollment…

Thanks, Faye. And thanks to everyone on the call for joining us today. Please refer to the press release we issued this morning, which is available on our website for detailed financial results. As of September 30, 2022, we had approximately $195 million in cash and marketable securities. This includes approximately $4 million in proceeds from warrant exercises that we received this quarter. Overall, operating expenses were higher for the three and nine-months ended September 30, 2022 compared to the prior period, which reflects increased activity across the company, as well as accounting for the recent settlement agreement related to the class action lawsuit. On the R&D side, the increase in expenses for the three and nine-month periods of 2022, compared with the same period in 2021, primarily reflects the net result of increased personnel related expenses for additional headcount and higher consulting costs related to preparation for top-line results and regulatory submissions in low risk MDS, which were partially offset by decreased manufacturing costs due to the timing of imetelstat manufacturing batches. On the G&A side, the increase expenses for the three and nine-month periods of 2022, compared to the same period in 2021, primarily reflects increased costs for commercial preparatory activities, higher personnel related expenses for additional headcount, and an accrual of approximately $7 million for our portion of the settlement for the class action lawsuit, which we expect will be paid in either shares of General common stock and or cash at our election, after final approval of the settlement by the court by the end of the first quarter of 2023. We continue to expect non-GAAP total operating expenses of up to $150 million for the full-year of 2022. Under current funding assumptions, we expect to have approximately $140 million in cash and marketable security at the time of the low risk MDS top-line results in early 2023. We also expect to have up to $171 million in additional funding available to us in 2023, which is comprised of approximately $121 million from potential exercises of currently outstanding warrants and an additional $50 million from potential debt drawdown under our current loan agreement upon the achievement of certain milestones, and capital requirements. Under current planning assumptions, we project our existing capital resources plus the projected future proceeds that I just outlined, will be sufficient to fund our estimated levels of operations, which includes stage gated activities for potential U.S. commercial launch of imetelstat to low risk MDS until the middle of 2024. With that, I will now turn the call over to Chip for closing remarks.

Thanks, Olivia. As I indicated at the start of this call, we are on a journey toward becoming a leader in the treatment of hematologic malignancies. On this journey, we expect to achieve very meaningful milestones, which we believe will not only move the company from clinical development toward commercialization, but also potentially change the treatment landscape for lower risk MDS and relapsed refractory MF. Thank you all for your interest in the company and support for our continuing activities. We will be glad to take your questions.

[Operator Instructions] And your first question comes from Kalpit Patel from B. Riley. Please go ahead.

Thanks for taking the question. So there was a positive announcement earlier this week from Bristol Myers Squibb regarding the COMMAND study, testing luspatercept in the frontline setting for MDS. I guess, what implications if any does this have on your potential path for imetelstat? I think your trial is enrolling patients who have received luspatercept before. So curious if you see or foresee any shift in how imetelstat may be used in the real world, assuming the Phase 3 is positive and then does it change anything from a regulatory perspective as well? Thank you.

[indiscernible] out, the imetelstat IMerge Phase 3 trial does include patients who are previously treated with luspatercept. We expect imetelstat to become part of the standard of care in low risk MDS and to be broadly adopted for the treatment of these patients with very high unmet medical need. I would also like to remind all of us that, we had multiple other patient subtypes that were eligible for this trial irrespective of their inside blood status. This included heavily transfusion burden ESA relapsed and refractory patients and also frontline ESA ineligible patients, given their high baseline serum EPO levels. As Chip and Faye said in their prepared remarks, we expect imetelstat to be highly differentiated, given our distinct mechanism of action that targets and kills the malignant stem and progenitor cells and allows for the ability to modify the disease and achieve continuous and highly durable transfusion independence rates. This data, which is reported in today's ASH abstracts, directly addresses significant unmet medical need in low-risk MDS, and we expect it to be very favorably received by the physician community. I also want to remind everyone that from a commercial perspective, the market for imetelstat is addressing is highly attractive and approximately three times larger than the patient group indicated under the current luspatercept level, which is limited to RS positive patients. We expect broader adoption and remain confident that what imetelstat is addressing is truly disease modifying and we expect broader option. So I will just stop here.

Okay. And one question on the IMerge readout that is coming up in January. What level of detail should we expect on some of the secondary endpoints maybe the one year TI rate and some of the other endpoints there?

I think you should expect the secondary endpoints would include of course the 24 week TI and obviously all of the safety data as well as the primary endpoint. Faye, any other comments?

But add HIE as well.

Okay. So we shouldn't see any one year TI rates there in the Phase 3 readout?

Not sure.

Okay. Alright. Thanks for taking the questions.

Your next question comes from Steve Willey from Stifel. Please go ahead.

Yes, good morning. Thanks for taking the question. I guess, maybe just following up on the top-line disclosure in January, I was just curious if we should expect to see any specific efficacy data within certain subgroups of interest and I guess the subgroups would be those patients who have a very high transfusion burden at baseline, maybe have serum EPO levels of greater than 500. Is that something that you think will be saved for a future presentation or is that something that we could see in a top-line press release, just kind of giving the importance of that from a competitive differentiation perspective?

Thanks for your question. I will take that. Yes, we will have subgroup analysis at the time of TLR. We will provide additional data, of course at a major medical meeting subsequently.

Okay that is good to know. And then maybe just a question on improved MF. I guess when you look across the competitive landscape, it kind of seems like there is an effort to combine various agents with rocks that actually address some of the anemia that is caused by rocks. And just curious, just given I think in the Phase 2 IMbark study, there was a bit of an anemia signal from imetelstat. How do you just think about the notion of potentially exacerbating the toxicity that is across the competitive landscape trying to be -?

Faye, do you want to comment about that study?

Sure. The IMproveMF study is as I say are combination study in frontline patients ruxolitinib and imetelstat. And the primary objective of that study will be to assess the safety profile of the combination therapy, including any potential cytotoxicity and cytopenia that is the main objectives.

We are not 100% sure, what we are going to see and that is why it is really a safety study, as opposed to primarily an efficacy study. We will obviously look for efficacy signals and, of course, the paradox here is that we know that we have in the Phase 2 data, certainly very strong, immuno responses, positive immuno responses. And so I think, we will just have to see how it works out, but I think would be - the real focus of this is indeed getting a safety look.

Okay. And then just lastly, I guess on IMpactMF, congrats on getting a lot of the sites opened. How should we think about the manner in which you are going to be communicating enrollment milestones or is that something that you will not be providing? And I guess I'm just thinking about whether or not we hear as to half of the patients have been enrolled or just various milestones like that?

Yes. Historically, Steve, we have communicated when we hit 50% enrollment, we will probably do that with this study as well. Of course, I would want to remind everybody that because this is an overall survival study, and it is really event driven, the specifics of the enrollment kinetics, while they are certainly linked to that, you can't have events unless people are enrolled. At the same time, we are not on a hard schedule of events where enrollment completely dictates when results come. So we still currently expect the interim analysis in 2024.

Okay that is helpful. Thanks for taking the questions.

Thanks Steve.

Your next question comes from Gil Blum from Needham & Company. Please go ahead.

Hi everyone and good morning and thanks for taking our questions as well. So make a quick one on the world presentation, the long-term follow-up of the merger kind of struck me that some of the details your provided there looked a lot like what you saw in MF regarding the reduction of specific clones. So maybe a longer term thought is there then a reason to consider making an overall survival outcome study and MDS at some point? Thank you.

Sorry, just to make sure we understood the question, we were having a little bit of trouble hearing you. Could you just - so overall survival. Obviously, you I think you were trying to relate the question about overall survival in long-term follow up of MDS, did I get that right?

Yes, that is correct, because the results will look a lot like what you saw in myelofibrosis on a molecular level.

Yes. Fe do you want to comment on that?

Sure. Thanks for confirming. So, overall survival and addition to progression free survival are both secondary endpoints on the Myelodysplastic Syndrome study EMERGE. So we will be looking closely at that.

Okay, excellent. And as for the combination studies in AML, preliminarily you are going to first look at the single agent activity and then add combinations on top of it. But how do you see that kind of the evolving landscape?

Initially, the goal of our combination studies and AML is evolving into and has been actually always treated with combination therapy and multiple approaches, especially in the frontline setting. As we investigate the safety of the combination therapy in the telomere study, combining with either venetoclax or Azacitidine in addition to the safety of course, be looking for any preliminary signal of efficacy. Yes, and there is a clear need for a novel mechanism of action that works differently than the currently available therapies in AML, and especially in relapsed refractory AML.

Okay, thank you for the clarification and thanks for taking our questions.

Sure.

Your next question comes from Joel Beatty from Baird. Please go ahead.

Good morning and thanks for taking the questions. The first one is on the Phase 3 MDS trial EMERGE. Could you discuss the DSMB review that have taken place throughout the study and recently and anything learned about safety there?

The thing is requested, we have an independent data monitoring committee in place for the study who reviewed the unblinded safety data. And to-date they have continued to recommend the study proceed as indicated they meet on a regular basis.

Great. And then maybe a question on - Yes, terrific. Thank you. A question on the COMMAND study, whenever we get more data from BMS, could you discuss what data points you would be curious to look for?

I can take that question first, Joel, and obviously, Faye can add on to it. So one of the more important things in low-risk MDS especially for patients who are predominantly anemic is continuous and highly-durable transfusion independent states. In all our market research, from clinical scientific forums and discussions with our advisors, this remains a high unmet medical need and there is significant dissatisfaction in this market being expressed with agents that have been currently approved and have existed for the armamentarium for physicians to treat this disease. So we would look for the quality of data, the durability of TI in various subgroups and adoption is dependent on all of those things. But I also want to restate one more time, we target the malignant stem and progenitor cells. Imetelstat has the ability to modify the disease and what we are seeing in our Phase 2 data is highly encouraging in terms of continuous and durable transcription independence in high transmission burden patients. So the value proposition for Imetelstat should be very, very strong. But obviously, we would be curious to see what happens in the frontline settings. Faye, anything to add on your side?

I would add to that that I would be interested to see not only anemia improvement and improvement in hemoglobin, but the amount of transfusion burden reduction especially as you mentioned on a continuous basis in that study.

Great. Thank you.

Thanks Joel.

Your next question comes from Vernon Bernardino from H.C. Wainwright. Please go ahead.

Good morning, everyone, and thanks for taking my question. Thanks also for the update on the Phase 3 IMpactMF trial. It looks like that is making good progress. I'm curious about the IMproveMF Phase 1 trial in frontline myelofibrosis. I think, if I remember correctly, the study has been conducted in three sites. Just wondering how enrollment is progressing in that study. And then also, Faye, you mentioned the presentation of IMproveMF Part 1 or some of the data at ASH. Just wondering as far as the optimization of those in Part 1 of the study with ruxolitinib, what are your expectations as to how long those patients would be on ruxolitinib and then in the Phase 2 part, what if patients are not able to tolerate at least 12 weeks of ruxolitinib, how that study may be conducted and completed? Thank you.

Sure. Thanks for your question. I will start with the first one first regarding the enrollment. You are correct that we have our plan for three sites to be open. Currently, two of those are open, as this is a dose escalation study, we are proceeding with enrollment as expected at the various dose levels. And the next question was regarding ruxolitinib and how long we anticipate patients to stay on ruxolitinib. And I think that is one of the questions that the trial will answer and intends to answer of how long a combination therapy could be tolerated and whether there are options for a single agent treatment as well.

Okay. Just to follow-up then what kind of preliminary data might we expect in 2023 from IMproveMF?

We anticipate preliminary safety data.

Yes. I think, it is mostly related to safety. Obviously, if we see interesting efficacy signals, we will probably talk about that this is an early phase study. So we can do that. But we will have to see how it works out. It is an open question of whether the two drugs will be able to be combined. And we have great hope and then obviously, where does the dose go and so it is a dose finding study, as Faye just said, that is a critical element of it as we escalate dose.

Okay, thank you for taking my question. I’m very interested in the front line possibilities imetelstat MF thank you.

Thanks Vernon.

There are no further questions at this time. I will turn the call back over to Aron Feingold for closing remarks.

Thanks so much, everyone for joining us today and for your questions. We really appreciate you taking the time to dial-in and participate. Be well everyone. Thank you.

This concludes today’s conference call. You may now disconnect.