Geron Corporation Q1 FY2026 earnings call

• Progress on 2026 strategic priorities, including growing Ritello's commercial execution and advancing European commercial and pricing strategy. - Strengthened leadership team by welcoming new Chief Legal Officer and Corporate Secretary and two new board members. - Focused on three key initiatives for Ritello U.S. growth: commercial engagement, medical affairs research partnerships, and exploring European commercial strategy. - Reported strong Ritello commercial performance with 6% quarter-over-quarter demand growth and 12% increase in fee in prescribing accounts. - Engaged in medical meetings, expanded research partnerships, and achieved inclusion of self-test in NCCS chemotherapy order template. - Phase III IMPACT MF trial fully enrolled and projected to reach interim analysis in the back half of 2026.

RightOwl's first quarter net revenue was $51.8 million, an increase of 31% year-over-year and 8% quarter-over-quarter, placing us on track to achieve our 2026 net revenue guidance of $220 million to $240 million. Total operating expenses for the first quarter were $50.4 million, down about 9% year over year, and we are on track to achieve our 2026 total operating expenses of $230 million to $240 million.

We are reiterating our 2026 financial guidance. We expect Ritello net revenue to be $220 million to $240 million, with a greater portion of growth anticipated in the back half of the year. Our total operating expense guidance is $230 million to $240 million.

Statements that are not historical facts involve risks and uncertainties that could cause actual events, performance, and results to differ materially from those contained in forward-looking statements, referring to the risk and infirmities described in the earnings release and under the heading Risk Factors in GERON's most recent periodic report filed with the SEC.

Q: Hi. Good morning. So I have a question on MF. You know, I know we've been hearing this theme that physicians are very data sensitive in terms of awareness. So I was wondering if you had any updated thoughts on how you'll communicate the MF interim analysis this year. Like, would you consider giving any numbers in that release at all? And then with that, I'm also wondering if you think that the interim outcome could have any read through to potential uptake of Ritello and MDS.

A: This trial, as you know, is fully enrolled, and we do project that we will do our interim analysis in the back half of this year, so that's still on track. Typically, we think there are, you know, the DMC would meet, and we obviously were blinded, and we continue to want to stay blinded, depending on the outcomes, obviously, but the highest likelihood, at least from a planning perspective, we see is that they tell us, you know, keep on going. And if they tell us anything else, then all these material, obviously, that would improve communication to the market accordingly. But Joe, do you want to add anything? Yeah. Good morning, Tara. I think your question is how do physicians react to it? The second is disease or indication where you do have a proof of concept and an overall survival at that. So it definitely will have an effect, a positive effect, because Our message at MDS is that this is a disease-modifying agent, and having this proof of concept in phase three with overall survival in MMS would definitely enhance and augment that awareness and that value of the test set in the hematology clinic.

Q: Good morning, and congrats on the progress. Just a quick one from us. As it relates to European markets, you guys said you may have conducted some market research. Just sounding, you know, listening to your messaging, it kind of sounds like you're considering moving forward on your own. Is this fair, or is this still a question mark?

A: Yeah, good morning, Gail. Yeah, in line with what we have said is we want to explore all options to bring Ritello to patients in Europe. As you know, the European opportunity from a patient numbers perspective can be in line with U.S. opportunities, so it's quite significant from a patient numbers perspective. Of course, the second part of that is pricing, which is a very key inflection point for us. That needs work, and that's kind of the work that we're doing. If you think about options for a company like us, it's really three different areas. One is the classical built-up model. The second on the other end is a full partnership with another pharma. We are not doing the first, to be clear. That's not where we're pursuing a very big classical build-up. That's really not for us. Partnerships are always an option. But also what we are seeing in the marketplace deal is an emergence of new models and new partners in Europe that can complement what we're doing, because there are a lot of companies, US-based biotechs, that are having to put their thinking cap on and see how they can serve European patients. Many of them are choosing not to do anything about it, which we think is unfortunate for patients and for the mission. But at the same time, we want to make sure that we're doing It's thoughtful work. So we're pursuing all these different opportunities, Gail, and before the end of the year, there will be a lot of data markets in terms of where we land and what we think is the optimal way to bring Dritello commercially to the XCS market.

Q: As a follow-up, will there be real-world data from MFTelSTAT and low-risk MDS patients presented sometime this year?

A: Yeah, maybe I'll hand it over to Joe to address that. Yeah, we have a slew of research, investigator-sponsored research, including real-world data that will be presented at the upcoming meetings in the second half of this year, as we have been saying. Some of it will include the real-world utilization and the apps and the how it's playing out in the weak role. And the early, you know, indication that we have mentioned in the past is that the data reflects the I-merge data, you know, data from a responses as well as.

Q: Good morning. So I think you've talked about this 1L2L share, and it's been pretty stable in the 30% range. Maybe you could talk to us about the tactics you're using to increase adoption in the earlier line population, and when you think we could start to see those educational efforts flowing through to changes in actual prescribing patterns in a more meaningful way.

A: Yes, good morning, Corinne. I think if I heard you right, your question was about the first line, second line share of patients versus later. Okay, good, yes. So what we are committing today, Corinne, is the share of our organization, the first line, second line versus the later line is 33% this quarter with a 12-month look back. As you remember, last quarter it was at 30% with a 12-month So we continue to make progress in getting more and more of our patients in the first line and second line. And that's how we see our performance going forward is continuous growth, progress, continuous growth, quarter over quarter. And that's the strategy we're pursuing, iterating our guidance for the outlying between $240 million.

Q: Hi, good morning. Thanks for taking the questions. In terms of the 6% increase of demand in this quarter, what's your confidence in the sustainability of that for future quarters in 2026? And were there any seasonality changes impacts or other factors that you can specifically point to that helped increase demand in the first quarter?

A: Yeah, thank you, Emily. Yeah, look, I mean, we're pleased with where we are in Q1. Where we have landed is in line with our expectations in terms of both offline growth, but also on the investment side. And our plan is to continue to grow over quarter. That's the strategy we're pursuing regardless of seasonality, different things that will happen every year, we know that. But at the same time, we do expect a gradual and continuous growth quarter over quarter. This is one where we have communicated that we have a guidance for the year in terms of the top line. And we have also communicated that we think growth would be more accelerated in the second half of the year, purely by the fact that we have done significant surgeries in Q4 and Q1. And a lot of these programs do need time to take into action. And we want to continue to fuel this growth quarter over quarter. It's not that we don't see it as like a total transformation inflection point between one day to the other. This is a story for us of continued growth quarter over quarter. We do believe that the potential is tremendous in this low-risk MDS area, and we look forward to serving more patients and something for the better.

Q: Yeah, good morning. Thanks for taking the questions. Just curious about the data you're seeing on the treatment duration and persistency fronts. I know that you've been in the market now, I guess, messaging the correlation between cytopenias and clinical benefit. Has that driven any measurable improvement in patient persistency over the last four to five months? And then to have a follow-up.

A: Yeah, what we see in the real world is really quite close to what we've seen in iMERGE data. In terms of patients, average duration of patients staying on therapy, on Ritello, what we are pursuing is more patients in the first line, second line. And that would obviously increase the persistency of patients on treatment, right? So this quarter, we're up to 33%. last quarter with a full month look back, well, that's 34%. So, you know, we want to see that number continuously and gradually grow. But within the line, at this point, what we see is really in line with what iMerge has shown us in terms of, you know, average duration of patients on therapy.

Q: And then I just guess, you know, with the business approaching breakeven and presumably some level of confidence into achieving profitability, at least on a non-GAAP basis before the end of this year. Just curious how active some of the peripheral BD efforts might be right now and just whether or not there's a specific stage of development that you're looking for in an asset and whether you think there's both the appetite and bandwidth to potentially execute on a transaction. before the end of this year.

A: Yeah, thanks, Steve. So, I mean, ultimately, our main focus is on growing Ritello, especially in the U.S. for the time being, exploring, you know, ways to bring Ritello to XGS patients as well. We continue to do that. We have a healthy cash position with even more discipline from a financial perspective to ensure that we're executing per plan, but doing it in a financial discipline manner. And that provides us with, you know, a lot of different optionality in terms of, you know, wanting to do deals, not having to do deals. You know, staying opportunistic, looking at where else can we build our company in terms of what our long-term aspiration of building engagement policy, you know, a company that's consistent and sustainable. So that's ultimately where we want to go. So we do have optionality. It's purely for us to comment on, will we do a deal or not? We're always, you know, in the market looking for opportunities, but our, you know, very focused efforts are now on execution, making sure that price have a goal in line with our expectations. And really by focusing on those 8,000 patients in BS, in the second line, which we believe we can really help more and more of them as the quarters come.