Geron Corp (GERN) November 10, 2026 Conference Transcript

We're going to go ahead and get started. I'm Stephen Willey, one of the senior biotech analysts here at Stifel, and glad to have with us. From Geron, we have CEO Harut Submersion, and we have Joseph Ede, who heads up the R&D effort at the company. We're just going to have kind of a casual discussion. If anyone has a question, feel free to raise your hand. We'll get you acknowledged and hopefully get your question answered. Harut, Joseph, thanks so much for coming today. And any opening comments you'd like to make before we jump into Q&A?

Yeah, well, thank you, Steve, and thank you to Steve Hall for the opportunity to present our story. Our story continues to emerge as a commercial company. Now, last week, we have reported our fourth quarter of back-to-back growth. We're quite excited that our net revenue has now cracked the $60 million for the quarter. So that's an internal milestone we were very happy to see, all while being financially disciplined as well as we execute on our plan. And make sure that we set up ourselves not just for short-term growth, but also long-term growth. So, you know, from that side, Steve, you know, our U.S. business is on a very good trajectory, stabilized in terms of growth. We've demonstrated, you know, account growth. We've demonstrated the right patience mix. I'm sure we're going to get into that. So overall, that's good. And then on top of that, we've also given some additional color in terms of how we're thinking and executing on our XUS strategy, starting with Germany as well. So overall, you know, healthy growth and I'm sure we're going to get into that.

Okay. We can just jump right into Rytelo. Focus on low-risk MDS specifically. So I know you've been in this seat now for, what, 12 or 15 months or so. Where do you think you've made the most commercial progress? And where do you think there's still significant improvements to be made? And I guess what are the strategies right now that you're emphasizing in an effort to try to drive uptake?

Yeah, no. So I've been in the role since August 2025. So it's coming up to a year and a half almost. I mean, if you think about the arc of our strategy, in the beginning, it was really about like, what would it take for us to grow? And Ritello in the U.S. That was really our first focus area. And we had to start from a point where we actually simplified our operations in the U.S., and that resulted in the rift that we had announced in December 2025. And since then, we haven't really missed a beat in terms of going rapidly for a reset in our way of how we actually engage with the marketplace, starting with our academic medical centers, but really keeping an eye on the ball on the community-based physicians, because 80% of low-risk MDS continues to be treated in the community. This is the disease of the elderly and of the community. So when we really engaged with the academic medical centers, given that in the U.S., we didn't really have a lot of advocates. They weren't part of the iMerge program. And so we really expanded our ability to engage with that patient, with that medical expert population. And now with our more revised strategy in the community, focusing on the high volume accounts, focusing on a simplified message, really focused on the second line patient population. We're very happy to say that in the last couple of quarters, we've been reporting now that predominantly our growth is coming from the community. So I think that transition from first resetting the company in a way that it makes it very actionable to the academic medical centers, the engagement in the U.S., which happened now after the launch, but it did happen. Third, really making sure that we're shifting towards the community and how we engage with them. I think that's kind of what's really fueling our growth, and we were able to demonstrate that over the last four quarters now, back to back, with not just the top line growth, demand growth, expansion of the number of accounts ordering Ritello, and then the patient population that's coming from first line, second line, rather than just the late line patients, which we were getting. in the beginning.

Okay. So I know sales are kind of ultimately the barometer of progress here. But, like, what are some of the kind of the key commercialization metrics that you're focusing on internally in an effort to really kind of gauge, you know, how some of these strategic initiatives and messaging has been resonating with prescribers?

Yeah, I mean, sales obviously is the ultimate barometer, but it's a, you know, lagging indicator in some ways, right? That's why we give additional color in terms of where that's coming from, starting from, you know, saying that predominantly our growth is coming from the community. Obviously, that's an important area in our opinion because, you know, it is an indicator that that 80% of the patient population that is in the community, we're making head weights around that. That's why we have qualitatively as well mentioned this year or in the last quarter that we see Vitella grow for many years to come because of the fact that we're able to now make inroads on the community setting. So that's one. And then the second is, well, how much is our expansion of accounts that are ordering Ritello? And now we've reached 1,700 accounts, which is a very important aspect because, you know, every quarter we're growing another, you know, call it 100 to 200 accounts, new accounts that have never ordered Ritello before and now are ordering Ritello. It doesn't mean every account, 1,700, are all active all the time. It just means that that pool is continuously expanding over time, which is really great. And then the third one is, which type of patients are we getting? In oncology, hematology, as you know, Steve, a lot of the first wave of patients you get are really the tough-to-treat patient populations. Patients who've been on multiple different therapies, haven't really been able to get benefit or relapsed after a while, and now physicians are trying them on this new kid on the block. So that happens in the beginning, but you can't really bet on that. You really want to see the business move into the indications that we're approved on, which is in the second line patient population. So that's why one of the early indicators as well that we give is how much of our business is coming from that first line, second line. And that number has continuously increased. Currently, it stands at 36%. So more than one third of our patient population is coming from that first line, second line. And that has been growing 1% to 2% point every quarter with a 12-month look-back KPI.

Okay. So with respect to that growth that you're seeing in utilization within the front and second line settings specifically, where do you think this number can trend to over the next, you know, 12 to 24 months? Do you have any sense of the duration of therapy delta that you're able to capture kind of on a per patient basis by shifting use from third line plus to that first and second line setting?

Yeah, maybe I'll add some thoughts on that. And then, Joe, maybe you can add on the real world evidence as well. I mean, you know, in a perfect world, all our patients should be coming in a second line setting, right? Because that's kind of where our indication is. Unfortunately, that's not, you know, how real world works. We don't see it for us. We don't see it for Luspa or anything else as well. However, what we do see is there's a significant opportunity. In our estimates, there are about 8,000 patients in the U.S. who can benefit from Ritello in the second line setting only. And we're far, you know, from that number, which gives you a sense of the opportunity that we see in hand, you know, quarter over quarter growth, especially now that we're making inroads in the community setting. And the more we get second line patients, what we're seeing is the duration of response, you know, mimicking more and more the iMerge trial patients, which were around that 7.8 to 8-month period. Obviously, the first cohort of patients we got were in the later line patients, which typically are shorter than that eight months. But we also had recently some real-world evidence as well. Joe, if you want to expand on that.

Yeah, I mean, we had two publications in the summer and the fall showing that in the real world evidence, especially post-launch, the patients were more advanced and sicker, yet in terms of duration on therapy, they mimic in a lot of ways the IMERG study despite being a sicker population. But maybe part of your question, Stephen, is also the fact that the dynamic in the field of MDS is also evolving to loose by moving into first line, and that's pushing ESA from that first line spot. Knowing also that post-LUSPA, your CMA-EPO, increases to the point of becoming resistant to ESA. So that creates also more space for Immetelstat to grow into that second-line business, given that the HMAs now, according to practice as well as NCCN guideline, is positioned behind Immetelstat.

Okay. Maybe just going back to the kind of… Account question, the 1700 accounts. How does growth in that number attribute out like over the last, say, like three, six months, right? So if I wanted to kind of understand demand growth as a function of either breadth, i.e. account expansion or depth, more prescribing within the accounts that you have penetrated, how would that Demand growth attribute out between breadth and depth.

Yeah, I mean, it's going to be a combination of both for some time. I mean, that's kind of where I know the data junkies would like to identify every single one of them by itself. On the short term, it really doesn't matter. You need both to grow, and that's going to be part of our consistency of growth is in the beginning, we're going to take it from breadth and depth, whichever comes. That's great. What is important is that that physician ends up identifying the right patient, who is the second-line patient, and puts them on Ritello, identifies what are they going to see, understand how to manage cytopenia. Cytopenia is something that pretty much every hematologist knows how to manage, as long as they know that that's what they need to anticipate in the first cycle or the second cycle. And then how to go through it, why it's worth it. The data at ASH, last ASH, we've shown that this is an on-target effect. And really make sure that they're helping the patient get there. Because once they do that, then they're going to be seeing that long-term durable responses that we've seen in iMerge. Without that, they're going to see the side effect first without seeing the efficacy. And what we want to do is make sure that we're managing the patient so they get to the seat of the efficacy. Because the whole point is once they see the efficacy in their first patient, chances are they're going to use it in the second patient and the third patient. There is no lack of patience in this disease area. So that's why you need more accounts to use it for the first time with this new educational support manner that we're giving rather than just saying good luck to you. And that's kind of really, really important for us. And we monitor that, like, where are those patients starting for the first time? Have we visited them? So we have a lot of robust analytics behind it that we use to really guide our efforts there. But then, of course, you're going to have some of those, especially the larger volume accounts that we've been targeting in the last six to nine months, community-wise, seeing some of that repeat as well. So I would say for the next, you know, several quarters, it's probably going to be a combination of both, and that is totally fine with us. Once we get to a place where it's really mature, then that's where we would, you know, further slice and dice. But at this point, we have tremendous opportunity in both levers from that side.

Okay. So I know you're labeled for frontline use in high serum EPO patients who are ESA-ineligible, presumably also Lispaterceptin eligible. Do you see any frontline use happening in non-ES high, non-serum EPO high patients? Like, are some of these frontline patients presenting with just such high transfusion burden that, you know, a prescriber knows off the bat, was Patricep's not going to work here and ESA's not going to work here?

Yeah, maybe, Joe, you want to comment on that since you have covered it.

Yeah, anecdotally, Steve, what we've seen and what we've heard from prominent KOLs is that for the RS-negative population, for example, some of them are actually shifting to a direct first-line utilization for imitelstab, understanding that loose paracept is not as effective in the RS-negative group. Same with the ESAs. And, you know, some patients come in with a high transfusion burden as well, and those also do not benefit from ESAs or LUSPA as much. So those are the two groups, RS negative being a large one, actually. So we're seeing some of that as well. Okay.

Interesting. Maybe just kind of last U.S. focus commercial question. What level of granularity do you have just on kind of like the phenotype of what a second-line patient looks like? You know, do you know if this is skewed towards RS negativity? Do you know if these are patients who have primarily seen Lispatercept in the front line? What is that typical second-line patient that you're gaining traction in look like?

Yeah, I mean, more and more we're seeing patients who come off from LUSPA, and then they need another alternative. That's kind of where the market has evolved in a way where we like the fact that LUSPA has better data than the ESA in the frontline setting. That's great for patients, and to be honest, great for us as well, because ultimately, what are they going to go on afterwards? And on top of that, as you know, the recent NCCN guidelines that put us as a very clear preferred second-line agent ahead of HMAs, that's one area that we've been also focusing on is doctor really making sure that you expose your patient to Ritello before you try to nuke their bone marrow with an HMA. That option will always be there for you in the future, and that's important. So that kind of sequence in terms of more and more exposure in LUSPA for the first line, and then moving into the second line, in line with the update with the NCCN guidance as well, that's kind of what we're seeing more and more happening.

As LUSPA is displacing ESH in the first line. We're seeing two dynamics. Either patients are not tolerating LUSPA, fatigue being a major factor there, and serum EPO going up post-EMA, which makes them ineligible to ESA. So as LUSPA gains more ground, that also creates more space for mental health.

Okay. I know that there had been a lot of discussion regarding... How are you going to go about trying to commercialize Europe? I think the drug's been approved there now for about a year and a half. You just announced you're going to be pursuing kind of this gated launch strategy, I think Germany before year end, and then maybe France at some point next year. Can you just kind of give us a kind of a quick overview of What that process is going to look like structurally, right? How many folks are you going to need to have on the ground there in order to effectively launch this thing? And what should the expected impact to SG&A look like?

Yeah, no, good question. So, yeah, we're very excited about our translation of our ex-US strategy into action, you know? So if you think about, you know, any typical US biotech that has global rights for its assets, what do they, you know, do? It's either, you know, full-on partnership from day one. It's like, good luck, you know, you deal with it. Or, you know, some of the larger ones, like they've gone on and established their own operations in France, Germany, and all these companies. We have read that from the get-go said that we don't want to be doing our own operations in every major company. I mean, that's just not for us. At the same time, we have significant knowledge, expertise, and connectivity with European markets, especially in our management team, myself included, but not only me, multiple people in our executive leadership team has that. So we're pursuing a hybrid model in between. And what do I mean by hybrid is ultimately what really matters in Europe. The, you know, identifying the patients that we can help and the premium that we can command for the innovation that we're bringing to the marketplace. And the second bucket is probably the one that is the most important because the first bucket, I mean, we, you know, we have a lot of these physicians who are part of iMerge. We have a lot of connectivity with the physicians in Europe. We have a lot of goodwill with them. But we need to make sure that the pricing piece is done right. So that's why we have focused in the last year, like in 2026, on making sure we're advancing the pricing dossiers. Because to negotiate any of these pricing with the payers, you really need to build a whole value dossier that comes before that. And that takes about a good 9 to 12 months. So why would we not do that in anticipation of a potential pricing engagement? A lot of companies were not doing that because of MFM. And I get it. You know, the last thing we want to do is also, you know, impact negatively our value proposition in the U.S. At the same time, MFN, you know, was going to get clarified with time. And that's why, you know, we've chosen a gated commercialization strategy to say, let's advance the, you know, the pricing component. And then we see if it doesn't work, then we can, you know, pull the plug, no harm, no foul. But in a way, what has happened recently is as we advanced our, you know, preparations, and then we get, you know, more clarity on the MFN in terms of, as an example, orphan drug status is exempt. Well, we have one of those. So that means we're exempt. Okay, we have to worry about the normal business, you know, aspects of things. So that's why we are in a position where last week we have announced that we're going to be in a position before end of the year to actually do a commercial sale in Germany. And that would mean that there will be a visible price. It will be the pre-AMNOG negotiated price, but it usually gives you a good perspective of how we look at value. And we'll do that in Germany. And we're doing all this while maintaining our flexibility to do partnerships from a commercialization perspective. That's not off the table. But what we're not doing is just sitting and waiting and not, you know, leveraging fully the value that we can develop in Europe by pursuing a premium pricing strategy in line with the innovation that we're making.

Okay. Yeah, I know Germany is pretty unique, right, in the sense that you can price freely, right? You then have to... Kind of go through this benefit assessment with AMNOG and ICWIG, but I think there's also kind of a little bit of a carve out that exists in Germany as well, whereby if you do have orphan drug designation, which is what you have, and again, correct me if I'm wrong, right? But it seems that if you're if your sales are below this 30 million euro threshold. Then you're kind of insulated from that benefit assessment. Is that the right way to think about it?

Mostly. I mean, they do have, you know, we always say they have a path to pay for innovation, especially in, you know, orphan diseases, areas where there is a need for that innovation to happen. And we fall, you know, according to our assessment, in line with that. So that's why we've chosen Germany. One is it's a very good European market to start with, but also Germany is a reference country from a pricing perspective for other markets as well. So as we have our aspiration to make Ritello available everywhere, what we've always maintained is we don't need to be everywhere in the world. Ritello needs to be everywhere in the world helping patients. And for that to happen, we're preparing the infrastructure for that vision to be translated into reality, starting with simple things such as how would you even sell? How would you expense? How would you ship drugs? So a lot of work that, you know, is very normal for larger pharmaceutical companies, you know, I mean, these are some of the things that we had to put in place in a very cost-effective manner while reducing our OPEX this year by another $10 million, right? I mean, that's the part where, you know, you look at it and you say, yes, will there be some more SG&A next year? Probably. But we've also demonstrated our financial discipline in terms of if something goes up, something has to come down. Our top 10 list is always top 10. It's not 15. So if something is more important, we've got to kind of park certain things on one side. So that discipline that we've demonstrated over the last four quarters will continue. It's something that we do while expanding the opportunity for patients to benefit more from Ritello around the world.

You talked about the familiarity you have on an executive level with the way things work in Europe. Maybe you can speak to the differences. Of how low-risk MDS is actually treated in Europe versus the U.S. and why those differences might actually also be a little bit of a tailwind for you guys.

Yeah. Joe, do you want to tackle that?

Yeah, let's start, Stephen, by the fact that iMerge patients were mainly recruited in Europe. So we have hands-on experience and advocacy from the KOL. Germany tends to be similar to the U.S. in the sense that it's a distributed patient population between private practice as well as academic centers. France is more of a centers of excellence, hematology driven. So those are the two opposing models in Europe, and some countries fall in either of these models. It's an aging population. The population of Europe is, you know, in line, if not bigger than the U.S., so there's also a market size that is significant in Europe as well. There's also another aspect of the intervention is earlier in Europe. So you have patients in the weight NC in America, where in Europe the early intervention is adopted as well. Okay. So you have patients in healthier stage coming into first, second, and third line.

And last piece I'll complement is like HMA utilization as well as lower in MDS. You know, the practice of just buying it in bulk across different diseases, that's not, you know, typically a thing in Germany. So there's a few different things that we can really, you know, look at and say, well, this is going to be worth it.

Okay, so I know you provided revenue guidance for this year kind of early.

First day of JP Morgan, yep. In 26.

I'm guessing you're going to provide guidance in probably a similar manner for next year. Would that guidance not include or not contemplate anything Europe-related, or would you just kind of pin that guidance to U.S. only?

Yeah, we're finalizing our plan, Steve, in terms of, you know, when do we provide guidance and all that good stuff. We did provide it this year for the first time in the beginning of January, and we've stayed consistent after that in terms of reporting on our execution versus that guidance. And, you know, we continue to be on the net revenue mid to high end of that guidance while we continue to reduce our OPEX as well. And, yeah, we'll see. I mean, we'll probably provide guidance at one point as well. And because we do see growth opportunity for Ritello for many years to go. So we're quite excited about that. While on the OPEX side, you know, we have a pretty, you know, decent team in place. Yes, there will be certain things, ups and downs, but generally speaking, we're in good shape from an OPEX perspective. So, yeah, stay tuned on that.

Thank you. I know you discontinued the Phase III

impact MF trial a few weeks ago. I don't think there's any need to relitigate any of that, but can you just now speak

to, you know, how you're thinking about the development of IMITELSTAT and additional indications going forward?

Yeah, I would say, look, I mean, it's, you know, that was unfortunate when, you know, every time we have a phase three that that's negative or is not going to show demonstrable efficacy. That's not a good day. At the same time, I'd rather know now rather than in another couple of years and another 15, 20 million dollars in. And in some ways, it makes our story even, you know, more focused than before. So, grow the base business, look at expanding XUS for Ritello, not necessarily for the company, and then BD. So, what really that shifts for us is two things. One is continue a lot of those IST conversations that we're having, and we're presenting some of those ideas at ASH in a few weeks on Ritello itself. But then really take a look at as well, how can we supplement Britello and build a company, you know, beyond that as well in pursuit of deals as well. So that becomes more of a, you know, in the limelight.

Yeah, the BD side of it is interesting, right? Because I would imagine you now probably can. Look at things with a lot more clarity with that in the rearview mirror. What's the level of urgency within the company on the BD side? And I guess, how would you maybe just broadly characterize the opportunities that you're looking at right now?

Yeah, I mean, you know, the way we characterize it is we're hungry, but not desperate, right? So we have a base business that's going to grow. You know, this year, $230 to $40 million in terms of net revenue. And we're saying we see growth over multiple years. That's a pretty good starting point. Our financial discipline regard in a way where we put ourselves where we don't need cash in the foreseeable future. We can fund our operations. There's a lot of goodwill of folks who kind of look at our platform and say, okay, you have a growing platform. That's good. And then, you know, we hired our CBO. Now it's been a couple of months, very active, hit the ground running. We're retooling ourselves that way so that we can actually do diligence and things of that nature. And really, you know, for us, what would make sense is something which is more, you know, advanced stage or even commercial stage. You know, we build a very, you know, effective, you know, team in the marketplace in terms of community based. So it can be a hematology asset, it can be an oncology asset, because they're all community based, right? In the community, there is really no difference. And, you know, can we put another product in the same bag of those reps who are doing well on Ritello and also something else as well. So this is something that we're starting now, and we're going to be increasing our focus on that. In some ways, it's much clearer than we've ever had before.

Okay. Maybe just last question. I know you just flipped the P&L to profitability this past quarter.

Does that make it philosophically a little bit harder to

do a near-term transaction, which might, you know, reset that model a little bit in terms of path to profitability? Or is the ability to provide investors with kind of the... answer to the what's next question. Is that more important?

I would say the latter, Steve. I mean, for us, as we internally joke about it, we celebrate it for two minutes. After 30 years of, you know, turning it into a profitability, that's a good thing. But to be honest, that's not our super main, you know, focus. Our focus is on building a company, you know, leveraging Ritello in MDS, you know, providing additional opportunities, XUS, and monetizing that. And then focusing on BD as well. And for the operations, we're in good shape from a cash perspective. But of course, building a company as well takes some dough about that. So that's our focus area. But we definitely see a path to profitability, as we've demonstrated. It can happen. And next year, if we follow the logic of continuous growth while on the OPEX side, kind of being efficient and lean and mean, as we've demonstrated, we believe we're on the right track on the short term. And then with BD, that would be the health of the company on the longer term.

I know we're a few minutes over time, but Harut, Joseph, really appreciate it. Thank you, guys.

Thank you. Thank you very much. Appreciate it. Thank you.