Hello! And welcome to the Geron Corporation Second Quarter 2024 Earnings Call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. [Operator Instructions]. I would now like to turn the conference over to Aron Feingold, Vice President of Investor Relations and Corporate Communication. You may begin.

Good morning, everyone. Welcome to the Geron Corporation second quarter 2024 earnings conference call. I am Aron Feingold, Geron's Vice President of Investor Relations and Corporate Communication. I'm joined today by several members of Geron's management team. Dr. John Scarlett, Chairman and Chief Executive Officer; Dr. Andrew Grethlein, Executive Vice President and Chief Operating Officer; Dr. Faye Feller, Executive Vice President and Chief Medical Officer; and Michelle Robertson, Executive Vice President and Chief Financial Officer. On today's call, Chip will start off with introductory remarks on commercial execution and value creation. Andy will provide a commercial and operations update. Faye will speak to medical and clinical updates, Michelle will provide a financial review, and Chip will close with some final remarks. 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 launch, commercial opportunity, and therapeutic potential of RYTELO, anticipated clinical and commercial events and related timelines, the sufficiency of Geron's financial resources, and other statements that are not historical fact. Actual events or results could differ materially. Therefore, I refer you to the discussion under the heading, Risk Factors, in Geron's most recent periodic report filed with the SEC, 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. With that, I'll turn the call over to Chip. Chip?

Thanks Aron. Good morning, everyone. Thanks for joining us. It was just eight weeks ago that FDA approved RYTELO, our branded name for imetelstat, as the first and only telomerase, and it was just six weeks ago that RYTELO became commercially available in the U.S. With our strong commercial infrastructure in place at launch and the efficient mobilization of our field teams, we've seen encouraging early launch results. As of July 31, 60% of the top decile 1-4 accounts had been reached by our team across both community and academic settings. This has led to gratifying uptake. We estimate, again, as of July 31, that approximately 160 patients have received RYTELO, which is quite encouraging given the very early stage of this launch. The enthusiastic reception for RYTELO that we've seen within the hematology community reinforces the unmet needs for lower-risk MDS patients with symptomatic transfusion-dependent anemia. Many of our customers are passionate about getting access to RYTELO for their patients, and we've seen a strong push across the U.S. to add RYTELO to formularies, treatment pathways, and EMRs, including in the community setting. In addition, the MDS NCCN Guidelines were updated this July 25 to include RYTELO as a Category 1 and 2A treatment for lower-risk MDS patients. That is, RYTELO is now designated for use in both RS positive and RS negative first line ESA ineligible patients, as well as in both RS positive and RS negative second line patients, regardless of prior first line treatment. We believe that these favorable NCCN Guidelines have put RYTELO in a strong competitive position. During their portions of this call today, Andy and Faye will walk through how clinical, formulary and treatment pathway decision-making is guided by the NCCN Guidelines. With the introduction of RYTELO as a new therapeutic option, we're…

Thanks Chip. Good morning to everyone on the call. We have built a strong commercial infrastructure that has enabled us to activate the launch effectively. First, we are pleased with the early awareness of RYTELO among prescribers and payers. Based on our market research before FDA approval in May of 2024 of over 100 U.S. hematologists and oncologists, over 80% of those surveyed were aware of the imetelstat. One in three surveyed physicians indicated familiarity with the clinical data, and a majority of these physicians looked favorably on the efficacy profile and mechanism of action, which is especially important for first-in-class treatment. Payers are expressing high levels of interest and already have a strong understanding of the RYTELO U.S. prescribing information and IMerge Phase 3 clinical data. From an operational perspective, both dosage strengths of RYTELO, the 188 mg vial and 47 mg vials were available in our distribution channel for customers to order from specialty distributors as of June 27, 2024. Our distribution network is fully activated with our specialty distributor network actively supporting customer demand across hospitals and community oncology clinics. Across the contiguous 48 states, RYTELO is available to HCPs within 24 to 48 hours from our specialty distribution networks. We also believe that RYTELO's inclusion in the updated NCCN Guidelines has been important in spreading awareness among the prescriber community. The NCCN Guidelines are a highly regarded resource in clinical decision-making for prescribers as well as provide critical considerations from a formulary and treatment pathway development perspective. Generally, the top national payers and Medicare cover oncology medicines categorized as 1 or 2A treatment by NCCN Guidelines. Our patient access and affordability solutions are fully activated. Our patient hub is fully operational and supporting inquiries from HCPs and patients. Our J-code application was submitted in July 2024…

Thanks, Andy. And thanks to everyone for joining our call today. As Chip mentioned, on July 25, the NCCN published updated MDS treatment guidelines, including RYTELO for the treatment of symptomatic anemia in patients with lower risk MDS. We believe that RYTELO's placement in the updated NCCN Guidelines reflects the strength of our Phase 3 data, which showed the clinical benefit of imetelstat regardless of ring sideroblast status or serum EPO level, as well as the favorable U.S. prescribing information, where RYTELO is indicated broadly across RS positive and RS negative patients who are both ESA ineligible and ESA relapsed/refractory. The MDS NCCN Guidelines characterize lower-risk MDS patients without the del(5q) abnormality and with symptomatic anemia on the basis of ring sideroblast status and serum EPO levels without specifying red blood cell transfusion burden. Overall, and as shown in the purple comment boxes on the far right of this slide, these updated MDS NCCN treatment guidelines include RYTELO as a Category 2A treatment for both RS positive and RS negative first-line ESA ineligible patients and as a Category 1 treatment for both RS positive and RS negative second-line patients, regardless of first-line therapy. Diving into these guidelines in more detail. On the left side of the slide is a schematic representing the NCCN Guidelines for the treatment of RS positive patients. For ESA ineligible patients who have serum EPO levels greater than 500 mU/mL, imetelstat is included as a Category 2A first-line treatment. For RS positive ESA eligible patients with serum EPO levels 500 mU/mL and below, imetelstat is included as a Category 1 treatment second-line after luspatercept. Additionally, as shown in the 2-plus line at the bottom of the schematic, imetelstat is included as a Category 1 treatment for later lines of therapy after ESA or luspatercept treatment in…

Thanks, Faye. Good morning, everyone. For detailed Q2, 2024 financials please refer to the press release we issued this morning, which is available on our website. Now let me bring your attention to a few highlights from the quarter. As of June 30, 2024, the company had approximately $430 million in cash, cash equivalents, and marketable securities, total product revenue net for the three and six months ended June 30, 2024, was approximately $780,000. RYTELO became available for prescribers to order from specialty distributors as of June 27, 2024. Total revenues for the three and six months ending June 30 were $882,000 and $1.2 million, compared to $29,000 and $50,000 for the same period in 2023. The increase in revenue is due to product revenue from U.S. sales of RYTELO that commenced in June 2024. Total operating expenses for the three and six months ended June 30 were $70.2 million and $126.7 million, compared to $52 million and $92.1 million for the same period in 2023. Cost of goods sold was approximately $17,000 for the three and six months ended June 30, which consisted of cost to manufacture and distribute RYTELO. R&D expenses for the three months and six months ended June 30, 2024, were $30.8 million and $60.2 million, respectively, and $35.5 million and $62.7 million for the same period in 2023. Our clinical development costs for IMerge Phase 3 have decreased as we move into the long-term follow-up stage. Selling, general and administrative expenses for the three and six months ended June 30, 2024, with $39.4 million and $66.5 million, respectively, and $16.5 million and $29.4 million for the same period in 2023. The increase in selling, general and administrative expenses primarily reflects higher commercial launch expenses, increases in headcount, and stock-based compensation, recognized due to the vesting of performance-based stock options upon FDA approval of RYTELO. As of June 30, 2024, we had 220 full-time employees. We plan to grow to a total of approximately 230 to 260 employees by year-end 2024. Our projected full-year 2024 operating expenses are expected to be between $270 million and $280 million, which is unchanged from our prior guidance. Based on our current operating plans and assumptions, we believe that our existing cash, cash equivalents, and marketable securities, together with our projected revenues from U.S. sales of RYTELO, will be sufficient to fund our projected operating requirements into the second quarter of 2026. I will now turn the call back over to Chip.

Thanks, Michelle. To close, we're encouraged by our early commercial launch performance and the feedback we're receiving from customers and payers. We're pleased with our strong execution to-date, but also recognize that we're still in the very early stages of our U.S. launch, with many more patients to serve and many more customers to engage. We have conviction that RYTELO can become part of the standard of care for eligible patients in this high-end need, lower-risk MDS treatment paradigm and bring differentiated benefits to patients. And in addition to our launch in lower-risk MDS, we're also advancing our imetelstat development program in myelofibrosis, which, having positive outcomes from the trials, we believe will contribute significantly to the commercial value proposition for RYTELO in the future. Thank you. And we'll now open the line to questions. Operator.

Thank you. [Operator Instructions]. Thank you. Your first question comes from the line of Tara Bancroft with TD Cowen. Your line is open.

Hi, good morning, and thanks for taking the questions. So, I guess to start, I would love to get a better sense of expectations for the year and what you are targeting. And for that, I know you're probably not providing revenue guidance, but I think it would be helpful to know whether a couple of things, whether you think a J-code could be finalized potentially before January, and other metrics, like how soon you think the field team will hit 100% of the target prescriber base? Thanks.

Thanks a lot, Tara. Appreciate the questions, which you're quite correct. We have limited ability to answer six weeks into the launch. I think we're really, really happy with where we've ended up in such a short period of time, and think that that is – we hope that that's a harbinger of performance as we continue on. I think the J-code, I think we're guiding to the first quarter, because we are honestly not a 100% sure when it will come. History suggests that there is some variability at the end, but we gave that guidance, and I think we'll stick by it for the moment. As we get a little bit closer, we may or may not have more information, but as of the moment, I think we would still stick to the earlier part of the year. I think with regard to metrics on the Salesforce, wow, the Salesforce is completely engaged, as you can imagine. I don't actually have any predictions available to any of us on that, but I do know that they are as – what's the best word for it? They are as enthusiastic and as hardworking a group of both CAMs, not only the kick-out managers, but also the folks responsible for trade and channel and for all of the various activities involved in a sophisticated commercial launch. I think it's probably all we can say today, but thanks for the question. Look forward to seeing this all evolve over the remainder of the year.

Great. Thank you so much.

Your next question comes from the line of Carter Gould with Barclays. Your line is open.

Good morning. Congrats to Chip and team on the early days here. Appreciating that it's early, how would you, I guess that initial 160 patients. Would you characterize that sort of as a bolus or potentially something more sustainable? Again, I appreciate it's early, but would you sort of – you have a sense that these patients were sort of identified by clinicians ahead of the launch or sort of more spontaneous use? And then on the patent term extension side of things, my understanding as I recall, I think sort of USPTO has, I think, statutorily has like 14 months to respond to your extension. Is that correct? And is that a fair characterization of the timeline we should expect to hear back on this front? Thank you.

Okay. Thanks Carter. So with regard to the initial uptake and demand and the question of a bolus, you only know a bolus for sure when you see it in the rear view mirror, right. I mean, if the trend line continues, it's not a bolus. If it slacks a bit at some point, I guess you would say it is a bolus. All I can say Carter is, we did not in our own thinking model, we’re in a bolus. I think we've been pretty consistent about that and how we've said it. So it's a little hard to know exactly where this will go from here. We do think this is all very indicative of a strong degree of organic demand that really reflects all of the great things that really happened starting with the ODAC, which seems like a million years ago, but it wasn't. And then we got, of course, an excellent, very clean label. And then with the NCCN guidelines that really placed this as a forefront of potential standard of care in this space, I think all we can say is we're just seeing a tremendous amount of interest on the part of HCPs, on the part of accounts. And whether this is going to reflect a bolus or not, we don't really know, but I don't think that's something that we've anticipated given the bill and by – the buying bill nature of the mechanics around all of it. With regard to the PTE, I wish it was 14 months, that would be great. I don't know if it's statutorily there or not, I guess it is. But when we've spoken to our IP council and others, we're seeing anywhere from three to five years for the PTO to really get back with definitive, yes, you can apply it to this patent, you can apply it to that patent, etc. So I would not be holding my breath on that. It's out of our hands. We've done everything we can to make these applications, but the historical performance has been pretty slow.

Understood. Thank you.

Your next question comes from the line of Stephen Willey of Stifel. Your line is open.

Yeah. Good morning. Thanks for taking the question and congrats on the progress. I appreciate some of the early metrics here, but just curious, of the 160 patients that have started therapy, can you comment as to how many of those patients are actually paying per drug? Is there a yet to be worked out reimbursement process for some of these patients?

I think I'm going to let probably either Andy or Michelle take that. I have a few comments, but they may be in a better position to answer that question. Andy, do you have any thoughts about that?

I think its way early Chip to know. Although what we do know is that we haven't had any issues with any of the submissions that have been made to-date. These patients have just gone through their first cycle.

Yeah. I mean, I guess I would add that, again, as Andy said, we haven't received any pushback. We have a hub set up, a reimbursement process. Even with the temporary J-code, customers are pushing this through formularies and so reimbursement has not been an issue so far.

Steve, I guess the only other comment I would have, which may or may not be helpful in this regard, remember everyone, this is predominantly a Medicare population. And while we don't have as fine insight into the exact breakdowns of where reimbursement is coming from, we know that the majority of it is PHS. And that's historically not had a lot of pushback, as long as you have the NCCN guidelines where they are today for us in Category 1, Category 2A. So again, the early days, we may be able to give a little bit more insight into this, but I think the current situation as we see it, bodes well for the future.

Understood. And again, I guess, understanding that it's early, but do you have any early information on just whether or not you are seeing patients who are newly starting RYTELO being switched off of other salvaged therapy? And I guess in your conversation with physicians, is that a dynamic that you expect to play out as the launch proceeds?

Yeah, I'll take that. And then I'll invite my colleagues to make any additional comments, if any. Look, I think we just naturally expect some of these patients will be, as you said, patients from the third line if you will, or second or third line for sure. That would be natural in the availability of a new agent and so forth. But we don't really have a way to characterize that. Our information that comes to us on individual patient data is very limited, extremely limited, if any at all. We're really seeing the demand from accounts flowing into the specialty distributors and occasionally to a specialty pharmacy. And that's what we're really able to infer and figure out the dynamics on. I'm not sure when and exactly how much fine tooth detail we're going to get on individual patients. I think that's going to take some more anecdotal information and eventually perhaps even some studies or whatever. I don't want to promise anything here. Of course, we're deeply interested in knowing the answers to all of that. But six weeks in, I can tell you right now Steve, we're just not really 100% sure exactly the circumstances of these patients and exactly the buckets as it were, that they are coming out of. We're just grateful that they are there.

Understood. And then maybe just one quick question for Faye. Can you just remind us what the DLT window in the IMproveMF trial is? And for a patient who progresses on frontline rocks, are the next-gen jack inhibitors allowed in best available therapy?

Hi. So, the first question is about IMproveMF, correct?

Correct.

DLT window, I’m not – the cycle length is 28 days, and the DLT window is one cycle length. And the next question was about MYF3001 or is whether next-gen...

Whether the next-gen jack inhibitors are allowable therapy in the best available therapy control arm.

No. There are no jack inhibitors allowed on the BAP arm.

Okay. Thank you very much for taking the questions.

Thanks Steve.

Your next question comes from the line of Corinne Johnson with Goldman Sachs. Your line is open.

Hey, good morning, guys. Maybe if you could just help us think directionally about the trajectory of new patient growth from here, probably through like the early launch period. Do you anticipate that kind of the new patients coming on therapy will come at a relatively steady clip, that it could be more lumpy or that it would accelerate over time? And maybe precedent would be helpful as you think about the answer there. And then in terms of just target engagement, you mentioned obviously 60% of the top decile accounts. I guess how many patients on average are like from a range, are these accounts treating, and of that what portion would be eligible for RYTELO? Thanks.

I'll take the first one, which is the directionality, and as you said, the smoothness versus the lumpiness. I mean, I'm going to say the obvious, Corinne, so forgive me. This is only the second new product launch in the last, what, 12 years in low-risk MDS or maybe there's been a few others that they have been very modest launches. And so all we really – we don't have a lot to go on on this and six weeks isn't very much. I will say that maybe something that might be helpful is that we haven't seen a particularly, so far in all of six weeks, we haven't seen a particularly lumpy accretion of patients. It's been pretty steady, but it's hard to do a trend line based on that. Maybe then next time we talk, we'll have a better feel for that. But I don't see any particular reason other than just natural variation as things go on, that we would expect anything different than what we've seen to-date, but don't really know. In terms of target engagement, just a couple of comments about this. These accounts are a very wide variety of accounts. So some accounts are large hospital systems. Some accounts are individual practitioners, everything in between you can imagine. The top deciles tend to be larger aggregator accounts, many, many physicians. So I don't have an exact number of physicians, but I'm not sure how helpful it would be, because it is such a wide variety. What we do know is that we've had really good traction getting in. We've had excellent traction speaking to these accounts in person, and the number of accounts touched and reached and including the vast majority in person is growing every day. So Andy, again, I don't know if you have any insight into this, but I will invite any help we can give Corrine here.

Nope. I think that's it Chip. Yeah, I mean, account activation is accelerating, we believe that, so we're pretty pleased so far. And the top deciles, we obviously modeled based on flow of prior treatments when they went for that launch. But I don't know that it's more proportionality. I don't think we can give patient numbers per account right now.

Okay. Thank you.

Your next question comes from the line of Gil Blum with Needham & Company. Your line is open.

Hey, good morning everyone and thanks for including our questions. So I know this is very early, but is there any information you can provide about the split of these patients that were dose RS positive, RS negative, front line, second line, whichever information you have. Thank you.

Yeah. Thanks, Gil. Thanks for the question. We don't have it. It's not the kind of information that would come in at this moment in time. We get, this is pretty much demand information that we're able to give you. This is the number of vials going out the door. And what we eventually, I think we will try very hard to get that. We're as interested as anybody in the nuances of, again, which buckets these patients are coming out. But as of today, no, we don't have that, and it will take some tweaking of our information sources and how we get that over the next several, I would think many quarters perhaps, to actually get a really accurate view on that. But as of today, we just don't know.

Thanks Jeff. That's very helpful.

Sure.

And another question and then a kind of related one. How long do you think it would take until you start getting feedback from treating physicians as it relates to any challenges they are having at giving the drug or any other kind of bottlenecks? Thank you.

Yeah. Thanks. Well, I think that boils down to the people that we have deployed in the field. Again, I didn't invite Andy to comment about that, because if you remember that slide that he showed, we've got a really varied group of people out in the field, and I feel quite good about that. But Andy, you might want to just run through sort of how we get feedback.

Sure. Yeah. I mean, we have several channels obviously, but I think our med affairs team that's in the field and our Medical Affairs Hub, which is fully active, is right now probably the main source of flow of certainly information requests. I think its way early to start getting specific feedback. Again, given that we're only six weeks in, most of these patients are just through a single cycle of treatment. But we have seen a strong, and I think a strong volume of med info requests across a range of different areas, from efficacy and safety to dosing and reactions to the prescribing information. So I think that bodes well that physicians are interested and becoming more and more educated about treating with RYTELO.

All right. Thanks for taking our questions and congrats on the launch.

Thank you.

Your next question comes from the line of Kalpit Patel with B. Reilly Securities. Your line is open.

Yeah. Hey, good morning and thanks for taking the question. For the launch, I guess, do you have an early estimate or early sense of what the growth net adjustments would be for third quarter and how you anticipate that to shift over time, maybe into fourth quarter or early 2025?

I appreciate your question. I think Michelle's probably the best person to answer that question. Michelle?

Yeah. Thanks, Kalpit. I mean, we obviously only had one week for the June close and our growth to net calculation, so. I mean, it's a pretty straightforward growth to net breakdown of components. I mean, because it is a primary Medicare population. So we know the PHS is going to be one of our largest deductions in the growth to net. But I would say it's too early for us to really be comfortable and we need more data as the July sales close out and as well as the rest of the quarter, but we'll have a pretty good sense after a full quarter worth of sales.

Okay. Okay and as a follow-up, how are you viewing the current sell side consensus estimates for RYTELO in the second half of this year under your current launch projections?

Michelle, [Multiple Speakers]

So, I would say from a consensus perspective, as I mentioned before, I think that we need to sort of sit down with you guys and go through some of the assumptions, because they are definitely mixed among the different models and sort of mixed versus our internal models. And I think it's a lot on the annual cost per patient. There's a lot of variance between the models there, so which I think is probably contributing to that, would be duration of therapy and penetration is pretty varied. So, I think that we'll look to give guidance on that post this earnings call.

Okay. And then one last one on the NCCN guidelines. I guess, were there any surprises based on where imetelstat is positioned in all the different subgroups of the treatment algorithm? And do your internal estimates of the percentage of lower MDS patients that could be treated with RYTELO change based on this position?

Yeah, I'll take that one. And then if Faye listens in and has anything else to contribute, I'd encourage her to do it. It's a great question, Kal. So first of all, I think if you go back to, all the way back to top line results, you know what, close to a year and a half to two years ago, we identified at that point in time a couple of really big pockets of value here. The first one was of course, that we thought that we were effective regardless of our status, and so in both, the RS positive and the RS negative. Second of all, we did have enough patients, although not a ton of luspatercept patients previously treated. And as we used to say, that was a highlight of the previous year's ASH that we saw some really good results there. So we thought that previously treated luspatercept patients who were not doing as well as physicians would likely be important. We thought that the high transfusion burden patients would be very attractive. And then we also identified that it looks like the patients who had serum EPO levels greater than 500, that is the officially the ESA and eligible patients had done pretty well. And so, we actually saw from our Phase 3 results, pretty much the makings of where we ended up today. What I can say is the label, which of course did have some transfusion burden requirements on it, as you would expect based on the clinical trial, that didn't actually translate over to the NCCN guidelines, which is interesting, frequently is not the case in as NCCN looks at treatment algorithms, if you will. And then all the other pockets really are completely there. So, I have to say, I don't think we – what the pleasant surprise was, that there were no unpleasant surprises. I think we just got a wonderful NCCN guideline affirmation of what we've always seen as the value in these various different areas. So, I don't think that – I think it's pretty much what we were hoping for and what we had always imagined. So Faye, I don't know if you have any other comments about it. Great question though.

Well, yeah. Chip, I think you put it well. I think the only surprise was the pleasant one. We received everything that we were asking for and their strong Category 1 and 2A guidelines and a strong reflection of the data of the clinical trial. So, all-in-all, a good result.

Okay. Thanks very much for taking the questions.

You bet. Thanks Kalpit.

This concludes the question-and-answer session. I'll turn the call to Erin for closing remarks.

Thank you so much for joining us today. We appreciate your interest in Geron and look forward to keeping you updated during this very exciting time for our company. Goodbye.

This concludes today's conference call. We thank you for joining. You may now disconnect your lines.