Geron at Stifel 2025 Healthcare Conference: Strategic Adjustments for Rytelo

On Tuesday, 11 November 2025, Geron Corporation (NASDAQ:GERN) presented at the Stifel 2025 Healthcare Conference, unveiling strategic plans to overcome challenges in the commercialization of its drug, Rytelo. The company highlighted both hurdles and opportunities, focusing on shifting Rytelo's use to earlier treatment lines while managing cash prudently.

Key Takeaways

• Geron aims to reposition Rytelo for earlier use in treatment settings, particularly second-line therapy.
• The company is implementing a "surround sound approach" to increase physician awareness and engagement.
• Geron anticipates coexistence with luspatercept as a second-line therapy option.
• No specific sales guidance for 2026 was provided, but growth is expected.
• Ex-U.S. commercialization involves a phased approach with potential partnerships.

Financial Results

• Rytelo's net revenue stalled at nearly $50 million, with growth anticipated in 2026.
• Geron is exercising financial prudence by decreasing investment levels.
• The company is focusing on strategic initiatives to drive future sales.

Operational Updates

• Geron is shifting Rytelo's use from later-line to earlier-line settings, emphasizing second-line therapy.
• The company is enhancing physician education and patient management strategies.
• A "surround sound approach" is being employed to boost customer engagement and account management.
• Recent efforts have expanded Geron's reach to approximately 1,150 accounts.

Future Outlook

• Geron targets 2026 as a growth year, driven by strategic initiatives and an evolving treatment landscape.
• The company expects Rytelo to coexist with luspatercept in treatment pathways.
• Ex-U.S. plans include phased commercialization and potential partnerships, focusing on "no regret moves."

Q&A Highlights

• Geron addressed the implications of luspatercept's front-line approval on treatment dynamics.
• The company expects to benefit from Bristol Myers Squibb's first-line investments as guidelines evolve.
• Rytelo remains the only drug effective in heavily transfused patients, according to Geron.

For more detailed insights, readers are encouraged to refer to the full transcript provided below.

Full transcript - Stifel 2025 Healthcare Conference:

Stephen Willie, Senior Biotech Analyst, Stifel: All right, we're going to go ahead and get started. I'm Stephen Willie, one of the senior biotech analysts here at Stifel. I'm glad to have with us here for the next discussion Geron. I have Harout Semerjian, who is the new CEO of Geron as of a few months ago, and Joseph Eid, who runs up the R&D effort and has a lot of experience in the hematology space. Harout, I think most folks are pretty familiar with the Geron story, but maybe you can just kind of start us off with some introductory comments about the company, the asset, and then we'll just jump into Q&A.

Harout Semerjian, CEO, Geron: Absolutely. Thank you to Stifel for this opportunity and for you, Steve, as well to really share why we're excited at Geron as a company. I started today, actually, is my third month anniversary. I'm quite excited to be the new CEO of Geron, really working on imetelstat and helping more and more patients in the relapse, in the lower-risk MDS patient population. We're a hematology company. We're actually a commercial-stage hematology company with an approved asset in the marketplace as of last summer, which is the first approved telomerase inhibitor called imetelstat, and the commercial name is Rytelo. We have launched in the US. We have an approval in Europe. Now we're getting into our second year of launch and finding our feet under us.

We're quite excited about that, Steve, and excited to talk more about as this half an hour unfolds.

Stephen Willie, Senior Biotech Analyst, Stifel: Yes, as you just mentioned, you've been in the CEO seat now for only three months. Maybe you can just kind of tell us a little bit about yourself. What attracted you specifically to the Geron story and just how your prior experience aligns with what this company now needs to accomplish over the near term and over the longer term?

Harout Semerjian, CEO, Geron: Sure. I've been three months here, but I've been more than 30 years, 32 years actually in the space, in the biopharma space, 20 years plus of that was in oncology, hematology. I grew up in the Novartis oncology world under David Epstein. We were launching one new drug after the other. I worked and lived across the U.S., Europe, and international markets. Not every launch was great. At one head, I was the global brand lead for Gleevec when imatinib was the poster child of a targeted therapy and really learned a lot over the years. I came through commercial, but then transitioned over the last few years into a biotech mode as well. What really I love about Geron, that's what attracted me, is, well, we have a drug that works. That's important because ultimately in oncology, you want to make sure that you see that efficacy.

We do see that efficacy, especially in lower-risk MDS. We have a patient population that is quite desolate. Second-line, lower-risk MDS patient population, they really do not have many new options. That is very important. I would say we can identify those patients in three questions or less. That is also very important for a smaller biotech, that we do not really have to spend millions and millions identifying those patients. Last but not least, we actually have a very healthy cash balance that we can get things done, especially nowadays in this market. That is quite important. We have a commercial asset that has great efficacy data. We have a patient population that we can identify and help. We have the means to do that. I am like, where do I sign up? That is why I am here.

Stephen Willie, Senior Biotech Analyst, Stifel: All right. That was good context. Rytelo growth stalled out just a couple of quarters into launch. I guess I'm going to ask you what you think has been kind of largely responsible for driving that disconnect. I mean, this kind of went from some of the best phase 3 data that we had ever really seen and a really difficult to treat lower-risk MDS patient population, and then fast forward to a launch trajectory which didn't necessarily seem to reflect that. As you came into the company, what do you think was responsible for that disconnect between the value proposition of the drug per the data and then the sales performance?

Harout Semerjian, CEO, Geron: Yeah, I agree with you, Steve. I mean, the data with Rytelo is really some of the most robust we've seen and an NCCN guideline, which is even better than the indication. That is really very, very important. It's not typical in a new launch that usually you get, especially in oncology, hematology, that the first batch of patients that physicians put on are really the toughest to treat, third line plus, fourth line plus. They don't have any other options. They'll say, OK, let's try this new kid on the block, this new approved drug. Let's try it on. That part actually happens all the time across oncology, hematology. Typically, what you want to do after that is get over that third line, fourth line plus and really move into earlier lines.

I think this is kind of where there has been the discrepancy between market expectations and what really was happening. That is kind of where you see the sales. We kind of stalled. I mean, we stalled at the almost $50 million net revenue, but still we want to see the growth continuing to happen in line with what we believe it can. These are thousands of patients who we can help. That base business has to rise. I would say a few things which we already know. One is this trial was predominantly done ex U.S. So 90% plus of the trial has been ex U.S. A lot of the physicians in the U.S., a lot of the hematologists, did not really have a lot of clinical experience at the launch.

This is kind of where typically companies do a lot of this work beforehand in terms of getting that clinical experience. We are doing that now to ensure that there is a robust IST plan in place. A lot of the hematologists in the U.S. are really able to work with Rytelo to answer different clinical questions that they have in mind. There are certain things that you wish you can always go back in history and do. I have also seen a lot of biotechs, they really work on fumes until they get to their first approval. What we are here for is to really make sure that we turbocharge that growth. Obviously, it is easier said than done. These things do take time. That is where we are committed to do what we need to do and bringing in the folks who have actually done this before.

With the money that we have, we can actually do something about that. That's kind of our focus. We think we identify some of the reasons, and we're putting the course corrections for it so we can continue to see growth in 2026.

Stephen Willie, Senior Biotech Analyst, Stifel: How would you characterize, I guess, that kind of ease of fix with respect to shifting Rytelo utilization from this later line/experimental setting into the patient population, I guess, that was more defined by the study itself and is defined by the treatment guidelines, the NCCN guidelines?

Harout Semerjian, CEO, Geron: Absolutely. I mean, our trial has been in the second line plus setting, predominantly second line. In the real world, we're seeing most patients are being put third line, fourth line, fifth line. That is the intention, to really move upstream. Changing physicians' behaviors is not a light switch. It does take time to do that. What we are seeing is there is a clear difference between physicians who actually used Rytelo and what they tell us about their experience versus physicians who have not used Rytelo and what they tell us about their experience or their perceived experience. Physicians who've actually used Rytelo, they have a very positive effect of that in terms of what's the efficacy that they get through, especially if they know how to manage the patient population. This is an active patient population group.

You have got to manage the first couple of cycles as well until you get to that efficacy. The challenge we have is you have much more patients, much more physicians who have not used Rytelo than the ones who have used Rytelo. Our focus is to really make sure that the awareness is there about Rytelo, the efficacy of it, how do you manage those patients, how do you start your first patients, and really making sure that that awareness is there, the efficacy is there, the first experiences go well. Because once physicians get that and we put them in the camp of, OK, I get it, then we believe that can give us the depth of experiences or depth of prescriptions that really is needed. Currently, we are getting the breadth of accounts.

In the last quarter, we reported yet another 150 accounts who have used Rytelo for the first time to make the total at around 1,150 accounts. What we need is to continue to drive that, but also to get to a depth of prescriptions. That can only happen by first positive experiences, which we're focusing on.

Stephen Willie, Senior Biotech Analyst, Stifel: How do you think about moving the needle then on duration of therapy? I guess there is probably a component to that that is managing patients and physicians through those initial few cycles where there tends to be this response-driven cytopenia in some cases. There is also the part of this that is, OK, these are third, fourth, fifth line patients who are just going to progress a lot more quickly than they would otherwise if they were a pure second line population. What kind of visibility do you have right now into what duration of therapy looks like? Do you think that just kind of takes care of itself as the drug moves up into earlier lines, or do you still feel like there needs to be more active management around the first few cycles of hematological toxicity?

Harout Semerjian, CEO, Geron: Yeah, I'll answer part of it and then maybe Joe can comment on the patient profiles itself. What we are seeing in the real world is a very similar duration of therapy to our iMerge, our phase three, with the caveat that in iMerge, it was predominantly second line patient population. So the median duration was around eight months. In the real world, we're mostly seeing third line, fourth line patients. You can't compare. It's apples and oranges. Wherever we're seeing second line patients in the real world, it will be in line with the iMerge. What we're seeing is much more third line, fourth line, which would be shorter duration. To your other part of the question regarding the patient journey, Joe, if you want to comment on that as a trained hematologist.

Joseph Eid, Head of R&D, Geron: Yeah, Steve, if you recall the presentation at ASH where we presented Rytelo in different settings, we demonstrated that Rytelo works in all settings: first line, second line, third line, pre, post, ESAs, EPO high, EPO low, high transfusion burden. The one group that showed the weakest, if you will, was the post-HMA. There is a reason, because HMAs are more like a nuclear bomb going in the bone marrow where nothing grows after HMAs. When you are going past the second line, typically those patients are exposed to HMAs. That is where you see that reduction in durability because those patients do not have stem cells that can recover because of the HMA exposure. Now, the one thing that happened recently that is a positive, there has been recognition of the value of Rytelo in the earlier lines. The guidelines have been updated to move HMAs behind Rytelo in the guideline.

That was done over the last few weeks.

Stephen Willie, Senior Biotech Analyst, Stifel: OK. We'll see, I guess, what kind of impact that has on duration of therapy. I guess to your point, I mean, being used behind an HMA doesn't seem to make a whole lot of sense, just given that they give you comparatively less efficacy with worse hematological toxicity.

Harout Semerjian, CEO, Geron: That's the thing. I mean, the drug is good. It's just not magic. I mean, that's where we really want to educate the market to use it in the appropriate setting. And that's really, in our view, is the second line setting.

Stephen Willie, Senior Biotech Analyst, Stifel: OK. What kind of granularity do you have around data that kind of speaks to the type of patient that is being prescribed Rytelo? Is it skewed towards RS negative? Is it skewed towards RS positive? Is it skewed towards the higher transfusion burden patients, which I know do not have a whole lot of treatment options? Do you have that level of granularity on the real world data thus far? What does it say?

Harout Semerjian, CEO, Geron: Yeah, we're seeing patients more in the late lines, in the third line plus. We don't see any specific subpopulation where it's being used. To Joe's point, I mean, we work across different subpopulations, especially in the second line. That's our focus area as well, to really make sure that understanding is there, that awareness is there, where physicians can help patients the maximum with Rytelo, especially in the community where 80% of lower-risk MDS patients go for treatment. Those are the busiest physicians. They would see a case of MDS, but they might see a lung cancer, a prostate cancer.

There is a very important role that we have to play in terms of a very targeted, focused education to really ensure that the second line patients are being given the opportunity of Rytelo and not just the, "I've run out of other options. Let's try this new drug" kind of approach.

Stephen Willie, Senior Biotech Analyst, Stifel: So you're thinking about, I guess, the messaging and the resourcing of this drug in a way that is agnostic to any one specific patient subgroup?

Harout Semerjian, CEO, Geron: Exactly. I mean, we know the data that in our case, especially in RS negative, more difficult patient population, we work even better. Sometimes the messaging becomes a bit more complicated when you want to go and have a two-minute conversation with a community hematologist. Everything is on the table at this point in terms of refinement of messaging, refinement of targeting, really making sure that, yes, technically it's accurate, but we do not want to lose time in bringing some of these things to the marketplace. Because to the point Joe made, we really work across different subgroups. Our data is quite robust and quite durable.

We really want to make sure that physicians understand that what we're really trying to position is in that second line setting where iMerge data was and where the NCCN guidelines are even more helpful now as they're getting updated.

Stephen Willie, Senior Biotech Analyst, Stifel: You talked about how community prescribers drive most of the prescription volume in this setting. What does uptake look like right now, just between community and academic? Do you see any tangible differences in either the breadth or depth of Rytelo prescribing from either subgroup at this point?

Harout Semerjian, CEO, Geron: We do get patients from both subgroups. It is not a 20/80, where 20 would be the AMCs and 80% would be in the community. It is more, call it half-half at this point. We have work to do on both physician groups with differentials in terms of what we are doing. On the community side, there is a lot of education, especially for the first patient starts. That is really a focus area. With the academic medical doctors, it is really more making sure that we have the right clinical programs in place and the partnerships, especially through the surge of ISDs that we are doing, to make sure that they have a certain number of patients on drug and they can actually share some of that discussion with their communities.

We have seen that in an anecdotal way at the SohO Conference this year, where this was one of my first conferences that I attended. The team has been working with these hematologists at MD Anderson for the last multiple months. It was really a positive experience for me, although anecdotal, it's one or two kind of. Really seeing some of these hematologists who haven't necessarily put patients before to say, "OK, I'll co-chair your event. I'll put a few patients to make sure that I get some of that experience." They were reporting their positive experience, especially two of the patients that were reported were post-luspatercept with a significant positive outlook for the patients.

These are all the onesies and twosies anecdotally, but it really shows we're on the right track in terms of really expanding our partnership, both on the academic medical centers and on the community, with a differential so that we can solve their issues and make sure that Rytelo fits within their arsenal of treatments.

Stephen Willie, Senior Biotech Analyst, Stifel: OK. Do you think that luspatercept label expansion into the front line setting has had just any impact in terms of patient dynamics and how they're now flowing from front line into some of these later lines? Because if I look at the COMMANDS data, if I'm an RS positive patient, I'm going to have a median duration of response that's two plus years, three years. And if I've started on luspatercept back in October of 2023, when the drug was approved in front line, I may not become a second line patient until October of 2026. Do you get a sense that this flow of patient kinetics from earlier lines to later lines has kind of changed as a result of luspatercept now being used in the front line setting?

Harout Semerjian, CEO, Geron: Joe, do you want to?

Joseph Eid, Head of R&D, Geron: You're thinking about it the right way, yes, Steve. That shift in treatment of luspatercept from second to first line is going to create that space where those patients now we know do not respond to ESA post-luspatercept. With the recent NCCN guideline update moving us right behind luspatercept, it is going to make those patients essentially eligible to get the best drug that will work for them. If anything, that move is a positive because Bristol Myers Squibb now is investing in launching that first line. We are going to reap that benefit over time.

Harout Semerjian, CEO, Geron: We do really see us coexisting with luspatercept, which is great news for patients because now they will have a novel first-line therapy, and then we come right after as a second-line therapy. There is a coexistence that can happen. That is good news for the patients. Of course, it really helps us as well to really make sure that there are additional patients. To your point, that can take some time given the front-line market dynamics and longer durations that can happen. At the same time, it is not like luspatercept is curing patients. Unfortunately, all these patients, the vast majority of these patients, will progress. What do you do? You give them ESA? Do not think so. You nuke them with HMA?

Why wouldn't you use Rytelo, which is really smack where we've had our data, and it shows a very durable transfusion independence in that patient population as a second line.

Stephen Willie, Senior Biotech Analyst, Stifel: It seems like luspatercept has become fairly institutionalized as front line therapy in RS-positive patients, where the data, I think, is very good versus EPO, but.

Joseph Eid, Head of R&D, Geron: Their label is RS positive and negative. To your point, they work best in RS positive, less so in the RS negative.

Stephen Willie, Senior Biotech Analyst, Stifel: And so I guess my question was going to be, what are you hearing from physicians? Because I think the feedback that we've gotten thus far has been fairly mixed regarding Lispatercept as a front line treatment option for RS negative patients. Are you hearing something similar?

Joseph Eid, Head of R&D, Geron: Yes. I mean, remember, the Medalist study excluded RS negative. It was exclusively in RS positive. That's a second line plus study. The command had a fraction of the RS negative, 35%, as opposed to epidemiologically 60 plus percent RS negative. The label was broad, RS positive and negative. And physicians use it in that setting, regardless of the RS status. But realistically, those patients do not do as well. And that's why we are actually seeing some first line patients getting Imitelset because of the value of Imitelset in that first line RS negative group. But for the community docs and the generalists who don't discriminate or don't even test for the RS status, those patients don't do as well and as durable response. So they end up essentially in the second line quickly.

Stephen Willie, Senior Biotech Analyst, Stifel: What's your sense in terms of how physicians are making treatment decisions on the basis of baseline transfusion burden?

Harout Semerjian, CEO, Geron: Yeah.

Stephen Willie, Senior Biotech Analyst, Stifel: Right. You brought up Medalist, right? They excluded RS negative patients. They also enrolled close to 50% of patients who were high transfusion burden at baseline, for which that drug had no effect. If physicians are not discriminating between RS status as kind of a nodal decision for prescribing therapy, are they doing the same for transfusion burden as well?

Joseph Eid, Head of R&D, Geron: Yeah. I mean, again, physicians are creatures of habit and ease of practice. And if you recall, the NCCN guideline after Medalist recommended Lispatercept in RS negative group as well, although they had excluded that group. And the reason of the committee position at that point was, well, those patients don't have good options, so why not? So as far as those patients who are heavily transfused, the only drug today that is on the market that works is Rytelo. And it doesn't mean that our drug doesn't work in the low transfusion burden. It works better in that low transfusion burden because those are healthier. And the difference is mechanistic. Our drug doesn't just stimulate cells to exit the bone marrow, either from an erythropoietin receptor point of view or maturation acceleration. It actually cleans the marrow out of the ineffective hematopoietic cells, the mutated cancerous cells.

And that's a transition we see in the first two cycles, where we do see the cytopenia that does not actually cause bleeding or infection because those are ineffective cells to begin with. And you have recovery of healthier hematopoietic cells. And that's what ends up being behind the durable responses that you see with Rytelo and no other drugs.

Stephen Willie, Senior Biotech Analyst, Stifel: OK. So maybe just kind of wrapping all this stuff up, right? So I know in addressing some of these questions, you kind of talked a little bit about the strategic initiatives that you put into place. But where are we, I guess, in terms of the implementation of these initiatives? And when do you expect to start to see some of these efforts begin to pull through on the top line?

Joseph Eid, Head of R&D, Geron: Yeah. So last quarter, we have announced that we have increased our customer engagement boots on the ground between the field force, between the MSLs. So that's one area. And on top of that, ensuring that we have additional connectivity, especially on the awareness campaigns. Where we're really surging now is making sure that the entire team works together on the account management model. Because it's one thing to have more boots on the ground. It's another thing to really have that coordinated effort. And that's kind of where we're revisiting a lot of the KPIs in terms of the incentive plans, in terms of the connectivity of the entire team. And on top of that, we're layering the non-personal promotion, a lot of digital surge, a lot of advisory boards, really trying to make sure that we're connecting with the marketplace.

That is kind of what we're calling it, our surround sound approach. That is really needed to ensure that the benefit of Rytelo really resonates across the world. As you've heard from Joe, mechanistically, we have a very unique mechanism that is quite needed in this patient population. We also have a drug that needs to be actively managed in terms of the cytopenias. That is OK. There are multiple different oncology drugs that we've launched positively that do need that active management. We are not shying away from it because it is actually an on-target effect. We want to make sure that we're educating the market, having those first right responses in the right patient population so we can create the depth that we believe is going to happen. A lot of these are starting now. From a growth perspective, we think 2026 is our growth year.

That's kind of where the hope is. At the same time, we're also saying that these things do take time. I mean, we're just starting now to really make sure that we build on what we have and all the learnings that we've seen over last year. But we're very confident, given the drug profile, given the patient unmet medical need. Even the NCCN guidelines, they're getting updated. And it's always in a place where it puts Rytelo in even a better situation. All these things. And given that we do have the cash to really make sure that we fund this surge, we believe 2026 is a year of growth for us. So. And if I can add, Steve, the upcoming ASH, we submitted five abstracts. Five were accepted. I will point out to two iMerge publications and presentation. One is on the cytopenia correlating with response.

And again, that's mechanistic. It's on target. It's proven. And now we're seeing that the patients who do have cytopenia have the association with the most robust and durable response. The other one is a long-term follow-up, where we do have now, for the first time ever in an MDS second plus population, second line plus population, proof that this drug improves survival, PFS, conversion to leukemia, et cetera. No other class of drug has done that. So those are, again, going to be impetus for better awareness and valuation of Rytelo in the clinical practice.

Stephen Willie, Senior Biotech Analyst, Stifel: Is there a regulatory conversation to be had around maybe getting some of that longer-term data on a product label?

Joseph Eid, Head of R&D, Geron: Those are, if it's not predefined in the protocols.

Stephen Willie, Senior Biotech Analyst, Stifel: Those are all exploratory analyses.

Joseph Eid, Head of R&D, Geron: I mean, the timing was not predefined.

Stephen Willie, Senior Biotech Analyst, Stifel: Got it.

Joseph Eid, Head of R&D, Geron: The analysis had been done per prior agreements. But this timing was different.

Stephen Willie, Senior Biotech Analyst, Stifel: OK. Maybe just a couple of questions here to finish up. So you talked about 2026 being, I think, maybe a growth year. What's your philosophy around giving guidance for sales in '26?

Harout Semerjian, CEO, Geron: Yeah. We haven't given guidance on the sales side yet. But that's something we would definitely entertain going forward as we get more confidence in terms of where we are in our efforts. We have given guidance on the investment level. This year, we have dropped it a bit. And that's really because we want to be more prudent with our cash and make sure that we really last that as long as we can. And rather than doing 10 things, we'd rather do five things very well. So that's something we're looking at, Steve. And stay tuned.

Stephen Willie, Senior Biotech Analyst, Stifel: OK. And then maybe just lastly, what are your ex-U.S. commercialization plans? I think you've recently started talking about maybe launching in Germany under a named patient program. Just kind of bigger picture, what do you want Europe to look like for Geron?

Joseph Eid, Head of R&D, Geron: Yeah. We do have a European approval. I mean, obviously, that's more that excludes the pricing piece because that needs to happen on a country-by-country basis. So the auspice that we're working with is that Rytelo needs to be everywhere helping patients. We don't necessarily need to be everywhere given that we are a small US biotech. So there are certain things that are like no regret moves, such as investing in the HTA conversations across key European countries, regardless of if we do it ourselves or if we partner. That work needs to happen. So we're doing a lot of the no regret moves in terms of both identifying the number of patients per country, ensuring that we have the right expanded access programs, the right HTA conversations. And as we do that, we're also open to conversations.

We will see what is the best way to serve those patients across Europe. I would also say international markets as well, given that we have the U.S. FDA approval that also opens markets in international countries as well.

Stephen Willie, Senior Biotech Analyst, Stifel: And presumably being able to, I guess, write and re-accelerate the launch here in the US would probably have some implications on partnership economics.

Joseph Eid, Head of R&D, Geron: Well, that's the best way you can optimize partnerships ex US is by doing well in the US, which is kind of where our focus is at this point.

Stephen Willie, Senior Biotech Analyst, Stifel: All right. If there are no questions from the audience, Greg, do you have a question?

Greg, Unidentified: I don't.

Stephen Willie, Senior Biotech Analyst, Stifel: OK. Thank you. Haroot, Joe, thanks for the time. Really appreciate it.

Harout Semerjian, CEO, Geron: Thank you very much.

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