Geron Corp (GERN) September 2026 Conference Transcript

Good afternoon, everyone. Thank you for joining the H.C. Wainwright 28th Annual Global Investment Conference. My name is Emily Bodner, and I'm an equity research analyst at H.C. Wainwright. I'll be doing a fireside chat with Harut Sumerjian, Chief Executive Officer, and Joseph Ede, Chief Medical Officer of Geron. Maybe for those who are newer to the Geron story, if you could start by walking us through your lead asset, Immatelstat, or brand name Ritello, which is approved for low-risk MDS. Maybe walk us through the mechanism of action, how it differs from other options on the market.

Yeah, thank you, Emily, and thank you for ACO Invite for this opportunity to share our exciting journey at Geron, which has been a few decades in the making. And finally, we are a commercial stage company over the last couple of years, launching the world's first telomase inhibitor, helping lower-risk MDS patients in the U.S. and hopefully around the world. This is a mechanism that's very unique. It's a Nobel Prize-winning mechanism that really targets the disease itself rather than just masking the symptoms. We've launched Ritello in July 2024, so now it's been about two years plus and growing. and and we're very excited about the the potential of the struggle but also about the the development that we're doing over the last couple of quarters as well in terms of growth yeah so as you mentioned Reds Hollow was approved about two years ago so how has the launch progressed since then how have you kind of overcome some of those early launch challenges and what is your confidence going into the end of 2026 and with your revenue guidance you've provided of 220 to 240 million yeah I mean we're we're confident in Ritello's potential but also its trajectory we have given guidance in the beginning of the year in the first day of JP Morgan conference in January about the overall outlook that we see for this year of a Ritello net revenue sales in 2026 of 220 to 240 million dollars and lately we have reiterated that and actually we've said that we think we're going to be somewhere between the midpoint to the higher end of that guidance, meaning $230 million to $240 million. We've been delivering three quarters of growth back-to-back, which is good. And we know we have more work to do, obviously, but we also like the trajectory that we're on.

So as you mentioned, second quarter was your record quarter since launch.

So what are some of the key marketing and Salesforce aspects that you're finding are working best, and what's given you confidence in achieving that higher end of the revenue guidance for the year yeah and maybe i'll give some some additional color from a commercial perspective and joe uh feel free to comment as well from a more medical perspective um it's been in it's been a very good journey over last you know several quarters where we've taken the learnings i mean we are a small biotech there is a reason why the large pharma start their pre-marketing activities you know two years three years in advance that that usually is the case and certainly I've done many of those when I was in large pharma of course when you're a you know more tiny biotech you know you kind of are getting to the finish line on fumes in many times so you don't have that luxury and then what you do is in the first year you're having to learn what's working what's now not what's key is to really pivot very rapidly in areas where we can further grow Ritello so on commercialization asset we're really focused on the second line patient population in low risk mds how do you know they're a second line patient population well they were on something else before now they're a second line so it's much simpler especially in a disease where 80 of the business is actually in the community that's where it's really on us to make the messaging much much simpler as we get more into the community setting which we have been doing the segmentation in terms of where we're focusing, the high-volume community accounts is somewhere where we're really now focused. We had to do some work, to be honest, on the academic medical centers over the last 18 months, 24 months, given that a lot of our trials were done ex-US. So we wanted to expand on the academic medical centers' experience on Ritello, which is something that Joe Kahn talked about. But also, that's not just enough to really win in the marketplace, especially in the community. That's where we've been really revamping and honing up our skill sets. And as you said, our last quarterly sales were in the $57.5 million net revenue, which is the highest it's ever been. So that's from a more commercialization perspective, but also, Joe, on the medical.

I mean, there are two dynamics. Internally, we obviously focused post-launch on the academic centers to make sure that hands-on experience, mechanism of action, understanding, management of patients in particular when it comes to the cytopenia, which were all of these were new for a new class of drug. And as we evolved that, you know, pillar, we shifted to the, you know, community docs and from CME and small, you know, regional hematology meetings to make sure that Ritello is at the podium and in, you know, presentations. The other dynamic, which is external, is NCCN guideline has been updated twice since the launch of Ritello, positioning Ritello as a second line. But there's also dynamic change in the treatment paradigm for MDS. Lusparacet having moved from the second line to first line is also creating a positive support for the Vitello uptake because post-LUSPA serum and EPO usually is elevated, so ESA is not an option. And, you know, in the community, it's still a split between ESA and LUSPA. But as, you know, LUSPA takes precedent, you will have more patients that come straight into, you know, be treated with imitalsat. There's also a potential for LUSPA to move into non-transfused patients with the element study, obviously, being conducted. So all of these dynamics with the NCCN guideline and our, you know, support for the physician awareness and understanding are helpful to understand the disease, the metastatrol in improving the disease and taking its place in MDS treatment.

Yeah, that's great. And you mentioned kind of your focus on moving more into the second line setting.

Maybe just comment on where you currently are penetration-wise in the first and second line setting and how do you kind of reasonably expect that to grow in the coming quarters or years yeah we've been updating the market on multiple you know kpis in terms of leading indicators you know beyond just the sales to really show some of the dynamics of those curves one of them being the percentage of our sales coming from the first line second line setting in patients versus the late line setting and that has been growing consistently one two percent the The last number has been 34% of our business is coming from the first-line, second-line patient population with a 12-month look back, which is very good to see. That's kind of what we want to see that happening. And that's a very important indicator because, you know, iMERGE trial has been predominantly a second-line patient population. Our indication is in the second-line population. The NCCN guidelines support us in the second-line population. We do understand the dynamics that in the beginning, when you have a new therapy that's launched, a lot of the physicians will use it for the more needy patients. So later lines, that happens in pretty much every oncology asset that I've worked on. The key is to really move rapidly from there into where we've been studied, where we've been used, and that dynamic, we're seeing it more and more, which is really nice. And I would say the last piece of that as well is we have commented that in Q2, in the Q2 earnings call, our last quarter's earnings, predominantly our growth has been from the community as well, which shows that, you know, a lot of the education and the partnership that we've done with academic medical centers, now moving more into the community setting where the vast majority of the patients are, that's where we're starting to go. So we do expect that number as well to grow over time yeah maybe with the increase in accounts how has the mix been between kind of new accounts versus new patients or existing accounts within those settings that you're already in yeah and that's why we've been giving also you know quarterly updates on the number of new accounts coming online and that's that's been growing between 100 to 200 accounts every quarter of folks who have never ordered you know right hello before and are ordering right for the first time and that is a very important metric especially the first couple of years of the life cycle of Ritello we do imagine that that over time will come down in terms of the breadth and then what becomes more and more important is the depth so that we can get more and more patients from the same accounts especially the high volume accounts that's where you know Joe's team and now always team both have been very focused on the educational piece across our physician base. Why? Because we're really leaning in into what a good patient looks like, who can benefit the most, and why it's important to be proactive in terms of managing some of the cytopenias that they will see in the beginning. Why is that important? Based on the ASH data that we have released. So the whole story is coming together, but we got to be relentless in our communications and make it as simple as possible, especially as we move into the community setting, because the average time that those, you know, physicians have is very, very limited. And they see very different, you know, types of cancer patients, you know, from a lung cancer patient in the morning to a prostate cancer at noon and, you know, a low-risk MDS patient in the evening. So we really want to make sure that we're really part of that conversation rather than, you know, keeping the high-end science, you know, in our academic medical centers. And whoever else is needed, it's always there. but we also have very, very punchy and effective messaging so that they can treat the patients that they see in the way that they see it in the time that they have. That's what we're doing.

How do you characterize the addressable patient population in the U.S. currently, where Rytel is approved, and what could the peak opportunity look like from here?

Yeah, we haven't given any guidance on the peak opportunity, but at the same time, I think there's a few different metrics out there in terms of showing the size of what can be. One is the size of the business in low-risk MDS. I mean, we know that there is another therapy, right, with Luspatricep that's around, you know, $2.5 billion and growing, you know, only in low-risk MDS. Obviously, they have the first-line set, you know, indication and the second line. But, you know, usually a drug is not used in both indications, right? So if you're moving more and more in the first-line indication, that opens the opportunity for us in the second line. but it is a significant patient population so that's really something that is you know out there and important and if we are you know true to our guidance of 230 to 40 million dollars of net revenue this year that would be in this full second year of launch that's the kind of uh you know revenue coming in and we haven't even scratched the surface of all the you know additional markets where we can where we can serve more and more patients right i mean we have right tello worldwide rights we haven't done any deal uh and that's another area for us from a geographical growth perspective and the third i would say is the shape of the curve there are certain therapies that have very rapid uptake especially if a single mutation or some sort of a companion diagnostic where you can identify the patient and put them on typically what we've seen is a fast uptake of this but then you know more of a gradual um you know stability of that curve while in hematology assets in areas such as in mds what we've seen is growth over time and we do believe that the curve over here would probably be more of a mimicking continuous growth quarter over quarter and do that for a you know long period of time so we're very excited about the potential of Ritello in low-risk MDS, where with the launch in the U.S., we're already breaking a lot of that more small company or small net revenue aspect, where we see a lot of other companies sometimes get stuck in that $70 million to $80 million or $100 million. We're already blown through that. And why not be a product that is in line with a loose-patricep within our indication, obviously. So that can still be a significant revenue generating outcome, especially that we're only getting started.

And as you mentioned, you do have approval in ex-US markets. What have you kind of communicated about timing for expanding ex-US and what are some of the options that you're looking at?

Yeah, I mean, basically we're guided by the mission of, you know, Ritello needs to be everywhere helping patients. We don't necessarily need to be everywhere, you know, across the world. And that's important because we've all, especially in our executive leadership team, we have a lot of folks who have actually launched assets around the world. So we know how to do that. At the same time, we want to also make sure that we're doing the right thing for the patients and also for the company. What we have said is that we're looking at all different options. What we are not going to be doing is doing the classical put 60 people in Germany and 50 people in France. And that's really not for us. but at the same time in the world of mfn and other you know kind of market forces that are reshaping the way how launches happen in the world and launch sequencing i think everybody is having to relearn that that perspective it's not like somebody has mastered it because you know there's an mfn and then you hear about globe and guard and then you hear about certain things that will be in and certain things that will be out what is important is that we're prepared for all these different permutations of it and what we have committed is before end of year that we come back to the market with a you know ex-us strategy particularly a european strategy so meanwhile we're having those conversations and making sure that we are in a good place with the payer component because from a advocacy perspective we actually have even more advocacy ex-us than we had in the u.s initially why because our trials were predominantly european trials so we have a lot of those KOLs who would love to see Ritello helping their patients, and that's something we're going to capitalize on, but we also want to do it in a way that makes sense for the company, for patients as well. So stay tuned.

Maybe moving on to your myelofibrosis program, you have an interim OS readout coming in the second half of the year for your IMPACT-MF trial.

So maybe talk to us about that study a bit. what are what are the kind of expectations for the interim readout and is there anything you can share kind of on what would be considered positive yeah so this trial as we have mentioned has completed enrollment last september it's a large study 327 patients in a relapse refractory to jack inhibitor population with imitelstat versus best available therapy that trial started in 2020 and is continuing to obviously is ongoing in terms of treating patients that are still on study and had an interim analysis planned as part of the design. What we have shared at the last earnings call is the discussion that we have proactively started with the regulators both in Europe and in the U.S. to make sure that, you know, any interim analysis that is triggered leads to a positive outcome, meaning that the regulators would accept the parameters in 26, given the changes in the treatment paradigm for MF, as well as the changes in FDA personnel, policymaking, et cetera. We want to make sure that before we trigger an interim analysis and be unblinded that we have an alignment so the projection that we have laid out before as of now continue to be the same if there's any you know outcome from the discussion with the regulator that will alter that you know projection we will we will let the market know all right um and assuming the interim if if it was not positive and the trial continued to full analysis what's kind of your confidence level in the final analysis being positive based on the embark trial results you had i mean the os endpoint you know projection and confidence you know are still based on the same science that hasn't changed um you know the uh the base case for us has has been going to the final analysis given that typically for overall survival trials you know interim analysis are a high bar to hit and you know that's how you know it's a matter of science and data and events.

Maybe just talk a bit about the competitive landscape in relapsed refractory myelofibrosis. Assuming Immetal set where to get approved, what could the market look like in the post-JAC setting?

I mean, at this juncture, there's a lot of, obviously, MF noise in the market from acquisitions, new mechanism of action. A lot of that is interesting, but as of now, Now, the only drug that has a potential for approval in the next, you know, 48 months, I'm sorry, 24 months, is in the Telstab. You know, the other aspect of our IMF program is the combination, combination with the JAK inhibitor, because we believe that the relapse refractory monotherapy, you know, is dependent on impact. But a lot of the patients are being kept on JAK inhibitor because there's a rebound once you take a patient off JAK. So that data will be complementary to the impact as well.

Yeah, and in the phase two, we've seen almost a tripling of the survival signal, right? I mean, that's why we have, you know, started this large phase three trial in this relapsed refractory patient population with an overall survival primary endpoint. It's been six years in the making, which for a small biotech, that's a big undertaking but you know now it's fully enrolled it's been almost a year we're aligning with the fda just in case you know even with that higher bar in the interim it hits let's make sure that we have the conversations before we're unblinded rather than having those uphill battles no one wants to do that um and and as joe said you know for us from a planning perspective you know we think a lot of these trials will continue to go and mature they will need more the time to mature and meanwhile we we want to grow our base business we want to be prepared for myelofibrosis but we also have you know 300 million plus uh of cash on our balance sheet um and the idea is that you know we put that also to use so you know eight weeks ago we've hired our first chief business officer we're also getting you know ourselves ready and starting to imagine as we get our base business in a good shape with hundreds of millions of dollars coming you know this year we grow our business to where it's 230 to 240 million net revenue we have reiterated our opex guidance of 230 and 240 million so it doesn't take a genius that we're kind of starting to get to that point where we have optionality to do you know more as well so that's kind of what is exciting about our our journey uh emily that you know a lot of our base business, helping those folks, and saying that there's about 8,000 of them in the U.S., low-risk MDS in the second-line setting. Many people, to be honest, tell us, well, there are more low-risk MDS patients, and we agree. We wanted to have a conservative number, because even with a conservative number, with our pricing, it just shows what the possibility can be as a base business, and then you have our cash, and then you have now that we're going in the right direction. All this are really seeds for us to plan for making a hematology oncology company for many, many years to come. Today with Ritello and tomorrow beyond that as well.

Perfect. Yeah, I think that leads well into my last question. So maybe just sum up for us some of the upcoming catalysts that investors should be looking out for into the end of next year.

Yeah, I mean, a lot of what it is, is quarterly building up our business quarter over quarter. That's important, especially in the U.S. Finding new ways where we can, you know, bring Ritello's benefit to patients around the world. That's also something very important. Being ready for myelofibrosis, right? I mean, you start these trials years ago, and we started in 2020. And then, you know, you hope for the best, right? So it's fully enrolled now. So a lot of the heavy lifting that our clinical team did over the last, you know, six years, now it changed into more of the follow-up, making sure that the cleanup of the data happens. There's a lot of, you know, chasing ground that happens for all these different sites, making sure that we're having a very clean database over there. But also now with the BD kind of lens to say, OK, how would we do diligence? How would we, you know, pay for some of these things? And really making sure that we're having those conversations so that at any given time we have the optionality to really implement a long-term growth strategy, but really move carefully from the base to beyond that as well and continue to communicate to the marketplace. I think this team has shown that we're able to do that and we will continue to do that. So multiple different levers from large phase threes that we'll be breeding out, but also as a company, putting it in a good shape that with that, without that, we're able to build on Ritello's base business today and beyond.

Perfect. Thank you very much, Ruth. Thank you, Joseph. Thanks, everyone who's been listening in. Hope everyone has a great rest of their day.

Thank you very much, Emily.