Q3 2026 Geron Earnings Conference Call - GERON CORP

Hello, and welcome to the Geron Corporation Third Quarter 2026 Earnings Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star-1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to turn the call over to Dawn Shotland, SVP, Investor Relations and Corporate Affairs. You may begin. Good morning, everyone. Welcome to the Geron Corporation third quarter 2026 earnings conference call. Before we begin, please note that during the course of this presentation and question and answer session, we will be making forward-looking statements regarding future events, performance, plans, expectations, and other projections, including those related to our 2026 financial guidance, our current Ritello commercialization strategy, and related opportunities in the U.S. and the EU, the therapeutic potential of Ritella, other anticipated clinical and commercial events and related timelines, the sufficiency of our financial resources, and other statements are not historical fact, which of course involves risk and uncertainties that could cause actual events, performance, and results to differ materially from those contained in these forward-looking statements. Therefore, I refer you to the risk and uncertainty described in today's earnings release and other heading risk factors in Jeremy's most recent periodic report filed with the FCC, to identify important factors that could cause actual results to differ materially from those contained in these forward-looking statements and feature updates to Geron's risk and uncertainties disclosures, including in its upcoming quarterly report on Form 10-Q. Geron undertakes no duty or obligations to update its forward-thinking statements. Joining me on today's call are several members of Geronís management team, Haruth Samarjian, Chief Executive Officer, Ahmed El-Nawawi, our Chief Commercial Officer, Dr. Joseph Ede, Executive Vice President, Research and Development, and Chief Medical Officer, and Michelle Robertson, our Chief Financial Officer. With that, I'll turn it over to Harut to discuss JRM's progress in the third quarter. Thank you, Dawn, and good morning, everyone. We continue to execute our strategy to build a leading hematology company. We are delivering consistent Rytello demand growth, reinforcing our confidence in the low-risk MDS US commercial opportunity and Rytellos growth trajectory over the next several years. We also initiated a gated commercial launch in targeted European markets that gives us the optionality to scale up Rytelos availability through partnerships. week, we announced the discontinuation of the IMPACT-MS trial evaluating imetostat and relapsed endorefractory myelofibrosis following a recommendation by the independent DMC. We believe this is the right course of action for patients and for Gerald. In the third quarter, we continued to see increased prescribing from community practices leading to a quarter-over-quarter demand growth of 10% and net revenue growth of 5%, or $60.1 million. This represents a 27% increase in net revenue year-over year. This performance keeps us on track to achieve the mid-to-high end of our full-year 2026 net revenue guidance range of $220 million to $240 million and reinforces our confidence that Ritello has a long growth runway in the U.S. This year, we started executing our ex-U.S.-go-to-market commercial strategy, focused on addressing unmet patient needs and broadening access to Riteello while prioritizing U.S. price integrity. Recent developments, including the exclusion of orphan drugs like Ritello from the CMS GLOBE model, gives us the opportunity to serve more patients globally. We initiated a gated commercial launch to make Ritellow available in targeted European markets, beginning with Germany, where Riteallow is expected to be commercially available model by the end of this year. In Europe, our approach enables us to retain strategic control of pricing without having to establish full infrastructure in each market or commit to a large upfront investment. This hybrid model also allows us to remain flexible and open to partnership opportunities. To support our global reach, we recently increased our engagement and presentations at multiple international medical meetings and were encouraged by the interest from hematologists in key markets. We will continue to explore opportunities in other geographies where we believe we can help address the significant unmet need of low-risk MDS patients. As we continue to strengthen our operations, another area of focus for us is financial discipline, where our investments are intentional and targeted. Our operating expenses were down 9% year-to-date compared to the prior year, reflecting our continued focus on operational efficiency. This discipline is enabling us to update our full-year 2026 total operating expense guidance range from 220 million to 230 million dollars with 339 million dollars of cash on hand we have a strong balance sheet to fund our current operations which gives us flexibility to pursue business development opportunities with that i'll turn it over to nawawi to provide more detail on Rytelo's commercial performance and our execution. Thank you, Harout. We are pleased to report our fourth consecutive quarter of demand growth for Rytel, reinforcing the need for this drug and its potential long-term value as a preferred treatment in second-line low-risk MDS. In the third quarter, we achieved a 10% demand growth for Rytello compared to the second quarter of this year, an 8% increase in prescribing accounts, predominantly from community practices, expanding our footprint to more than 1,700 accounts since launch, with first and second line patient starts on a rolling 12-month basis at 36%. We believe that Rytallo has the potential to deliver consistent quarter-over-quarter growth for years to come, driven in large part by continued adoption in the community setting where there are still thousands of patients that can benefit from Rytellum. Our focus is on accelerating that adoption through targeted personal and non-personal engagements that reinforce Rytello's differentiated clinical efficacy in second-line low-risk MDS patients while continuously educating hem-oncs on dosing and management of cytopenias. Rytello's unique mode of action as a first-in-class telomerase inhibitor, its broad label and position in NCCN guidelines provide a strong foundation to drive durable long-term growth. Turning to our efforts in Europe, we're taking a gated operational approach where we drive regulatory engagement and local reimbursement process to ensure Rytello reaches the appropriate patients at a price that reflects its unique value. Our model allows us to broaden Rytellos access with a staged upfront investment while preserving flexibility for the future. We have already initiated our launch in Europe and plan to make Rytallo commercially available in Germany by the end of the year, with France to follow in 2027. We're encouraged by the interest we're seeing across markets, supported by investigator experience with imitalistat, and the significant unmet need in low-risk MDS. I now turn it over to Joe to discuss our medical and scientific engagement efforts. Thanks, Nawawi. Last week, we announced our decision to discontinue the Phase III IMPACT-MS trial, evaluating imetalstat and JAK inhibitor relapse refractory myelofibrosis. This decision was based on a recommendation from the Independent Data Monitoring Committee informing us that the trial was unlikely to meet its primary endpoint of overall survival. Importantly, there were no new safety signals observed in the trial that changed the known safety profiles of imetelstat. We are committed to unblinding the data, conducting a detailed analysis of this rich data set, and sharing findings at an upcoming medical meeting that may help inform future research. We are deeply grateful to the patients and families, as well as the investigators and clinical teams whose dedication made this research possible. Turning to low-risk MDS, this quarter we presented at leading hematology meetings, both global and regional, further communicating the growing body of evidence supporting Vitello's differentiated profile, including evidence of disease-modifying activity. Just as importantly, these meetings created meaningful opportunities to engage directly with the medical community, exchange insights, and deepen scientific dialogue around the evolving treatment of low-risk MDS. At SOHO, we continue to build strong momentum through impactful data presentations, sponsored dedication and broad KOL engagement powered by a coordinated full-team approach. Our low-risk MDS real-world evidence poster showed meaningful hemoglobin improvement within the TELSTAT despite short treatment duration and later line use in U.S. community oncology practice in the immediate post-launch period. This marked the second real-word evidence presentation this year, adding to the growing body of evidence that reinforces findings from our Phase III I-MERS trial and the safety, efficacy, and tolerability profile of Ritello. Additional data presented at the 88th Annual Meeting of the Japanese Society of Hematology and the 2026 Annual Meeting for the German, Austrian, and Swiss Societies for Hematography and Medical Oncology further highlighted the durable clinical outcomes observed within and expanded the growing body of evidence supporting its differentiated profile. Across the presentations, Phase III I-MERGE findings and real-world experience reinforced durability and clinical relevance of treatment outcomes, including findings suggesting that treatment-emergent cytopenias may reflect an on-target effect associated with meaningful clinical outcomes, such as hemoglobin improvement and transfusion independence in low-risk MDS. Importantly, the presentations also demonstrated growing scientific interest and investigator experience with Imatel-STAT outside the U.S. as we continue to deepen engagement with the global hematology community. Beyond Congress presentations, we continue strengthen the scientific foundation of Ritello through two manuscripts published in peer-reviewed journals, further expanding the body of evidence supporting Imetelstat's role in low-risk MBS and its potential to address significant unmet need. Looking ahead, the 68th ASH annual meeting in December will provide another opportunity to build on this body of evidence with new data across low-risk MBS and other hematological diseases that will further inform our understanding of Ritello's clinical potential. Our six accepted abstracts at ASH reinforce the clinical and biological evidence of Ritello, and we look forward to sharing additional details later today. Our progress has been recognized beyond the medical community. We are honored to have been nominated for the Pre-Dallium USA Award for Best Product for Orphan-Aware Diseases. This recognition represents decades of pioneering work in telomerase inhibition and, most importantly, a sustained commitment to addressing significant unmet needs for people living with low-risk MDS. It is a meaningful acknowledgement of the science behind Ritello and the potential to translate that science into better outcomes for patients. I'll now hand it over to Michelle to walk through the financials. Thank you, Joe, and good morning, everyone. For more detailed results from the third quarter, please refer to the press release we issued this morning, which is available on our website. Our third quarter financial results highlight the progress we are making on our commercial strategy and operational excellence. We are in a strong financial position with a balance sheet that enables targeted and disciplined investments into further growth opportunities, including business development. In the third quarter, total net product revenue for the three-month-ended September 30th, 2026 was $60.1 million compared to $47.2 million in Q3 of 2025. Gross-to-net deductions decreased to 19.3% for the three months ended September 30th, 2026, compared to 21.6% for same period in 2025. For the remainder of 2026 we continue to expect gross-to net to be in the low to mid-20s. Research and development expenses for the 3 months ended in September 30, 2026 were $12.7 million compared to $21.1 million in expenses for same-period in 2025 The decrease in research and development expenses was a result of lower headcount costs from the workforce reduction in December 2025 and lower clinical chemistry manufacturing and controls costs. For the remainder of 2026, we expect continued investment in CMC and our clinical post-marketing commitments offset by lower employee costs. Due to wind down activities, we do not expect any significant decrease in spending on our MF program in 2026. Selling general and administrative expenses for the three months ended September 30, 2026 with $35.7 million compared to $39 million for the same period in 2025. This decrease was primarily due to lower general and administrative personnel related expenses as a result of the workforce reduction in December 2025. Total operating expenses excluding COGS for the three months ended September 30th, 2026 were $48.3 million compared to $60.1 million for the same period in 2025. As of September 30, 2026, we had approximately $339 million in cash, cash equivalents, restricted cash, and marketable securities compared to 327 million as of June 30, 2026. we are committed to maintaining our financial discipline and are well positioned to fund growth from our current operations we are reiterating our 2026 right hello net revenue guidance with the expectation we will come in at the mid to high end of the 220 million to 240 million dollar range reflecting consistent quarter over quarter net revenue growth throughout the year. We are lowering our total operating expense guidance from $230 million to $240 million to the range of $220 million to 230 million. This reduction reflects our ability to drive continued operational excellence while also making strategic investments into Ritello and future growth opportunities. With $339 million in cash, we are well positioned to execute on our financial and strategic priorities through the remainder of the year. With that, I'll turn the call back to Harouk for closing remarks. Thanks, Michelle. Ritello has grown for four consecutive quarters, placing us on track to achieve our 2026 net revenue guidance and maximize our long-term growth potential. Beyond Riteello, our financial strength gives us the flexibility to explore business development opportunities to build a leading hematology company operator we're now ready to start the q a session thank you as a reminder to ask a question please press star 1 1 on your telephone and wait for your name to be announced to withdraw your question please press star 1 1 again please stand by while we compile the q and a roster And our first question comes from Tara Brancroft of TD Cal, and your line is open. Hi, good morning. Thanks for taking the questions. So it's great to see the reduced OPEX guidance this year. It all makes sense. But I'm wondering how we should think about OPEC expectations really going forward, especially the MS phase three not factored in, if there are any savings from that, maybe you could tell us also what you plan to put that towards in terms of future pipeline or any thoughts regarding that. That would be great. Thank you so much. Yeah. Thank you, Tara. Maybe that's a question Michelle can address. Yeah. Thanks, Tara, so yes, we reduced our FX for 2026. So, yes, we reduced our OPEX for 2026. What I would say about the go-forward investments, we'll continue to be very disciplined in our capital allocation. You will see some increases next year as our Europe strategy matures, as well as a post-marketing commitment in clinical trials. So although the remainder of the OPECs will be steady, we will see increases for those two material items. Okay, great, thanks. Thank you. And our next question comes from Gil Plume of Needham. Your line is open. Good morning, and congrats on the progress here. So definitely seeing consistent growth quarter over quarter, kind of in the single digits. Anything could cause a rate change or change in the rate of uptake that would be more of an acceleration? And is this something we should expect, or should we continue to see this kind of like consistent growth over time? And I have a follow-up. Thank you. Thank you, Gil. As we have communicated multiple quarters ago, the way we look at Ritello's growth, if we do things well is it will deliver consistent growth quarter over quarter and we're very pleased today to announce the fourth quarter of that strategy in action where we continue every quarter to increase demand to increase sales to increase penetration the first line second line market uh patient segments and to reduce opex uh and and we believe that that's a winning strategy on the long term um you know that's that's kind of where where we are uh you know i know sometimes people ask us what is the exact inflection point you know and we continue to maintain this is a growth quarter over quarter if we do this well and we do believe that there are thousands of more patients who can benefit from right level for many years to come to come that's why we do see the long-term you know uh perspective of right yellow growth uh you're quite good but But the curve of the growth is really what we're pleased with, and we think that this is something that we can continue to grow. I hope that that answers your question, and I think you had a follow-up. Yeah, that was helpful. And just given the financial discipline here and a pretty meaningful cash position, you guys mentioned BD a couple of times. Is there a specific character product that you're looking for? Is this likely a heme-onc acid? I mean, any guidelines that you can give us to what you're thinking of? Thank you. Sure. Yeah, no, I mean – so, you know, if you step back and look at where we are as a company, you know, we have a very healthy base business in Rytello in the U.S. that's growing every quarter, and we've reiterated our, you mean, mid to high level of our guidance of $230 to $240 million, right? So that's from a U.S. perspective. We're also today, you know, very excited to share that we're surgically, you know, the work that has happened ex-U.S., especially in Europe, over the last several months, especially on the pricing side, puts us in a very good position to actually make the Ritello available in a commercial setting, starting with Germany before end of the year, and then rolling into other countries such as France next year while maintaining optionality of partnership which is really a win-win strategy that doesn't you know put us in a situation where we have to shell out a lot of from we do it in a very very you know specific way now coming to BD this also allows especially now with the MF overhang behind us obviously we're going to be looking into that very rich database and truly understand what are some of the trends in myelofibrosis. But given that that's really, it never was really part of our, you know, base strategy, at least not in the last couple of years. It was always treated as an upside. But now we're in a good situation to really pursue BD opportunities. So we have a winning team in the U.S. from a commercialization perspective. What would make the most sense is really to bring in another asset to put it in the bag of that team that's shown its ability to grow Ritello and to get into other, you know, hematology, oncology assets. As you know 80 percent of this business is actually in the community so it can really be any asset in hematogy or oncology that is predominantly a community disease. That's as a first, you now, kind of bullseye and then we would keep the right to be opportunistic beyond that, given that our approach of being very selective, targeted where we invest, and really drive value through that has now, you know, been taking life over the last four quarters, I would say, and we do believe we can do that, you know, with other assets. We're not competing with a Pfizer or a Novartis with, you know, needing assets with $2 billion, $3 billion peak sales, assets that have a few million potential peak sales is plenty for us. And then we can pursue a string of pearls approach with that over the next several years. So that's what we're excited about, not just for the base business, but also where we can go with BD. Does that help answer the question, Gil? Yes, very helpful, and thank you for taking our questions. Of course. Thank you. And as a reminder, if you have a question, please press star 1-1. Our next question comes from Steven Willey of Stiefel. Your line is open. Yeah, good morning. Thanks for taking the questions. Maybe just a quick housekeeping question for Michelle. Any notable changes to inventory during the quarter? And then I just have a follow-up. No, Steve, you just remain within our two-to-four guidance that we've shared in the past two- to-four weeks. And then just curious about how you're thinking about the opportunities here in Europe. I know that you're initially entering kind of a very limited number of markets, but can you maybe speak to any differences in how the disease might be managed there just relative to the U.S.? I guess when I look at Roblazol, you know, they're generating, I think, less than 20% of their sales ex-US, which I'm sure is partially pricing-based, but would perhaps suggest some differences in terms of how the disease is managed. Sure. Maybe I'll start off, and then we can supplement as well. Look, I mean, from a patient perspective, you know, it's really the same size of number of patients that we have in the S. You know, in the US, we've said about 8,000 patients would be eligible for that second-line patient population. And then, as you know European average age is even older. So, you, you it's at least that number of patient from a macro perspective overall. the reason obviously we're choosing Germany to go with I mean that is the country where you have a meaningful path for innovation in a you know a healthy pricing point in line with the innovation that we can bring now what would you want to add on top of that additional reasons to believe sure and a couple of points maybe see this you refer to that as a BMS it's not they've gone through several price iterations because of their closer label and multiple indications. We are a single indication drug with an alternate designation which does give us high scoring especially in Germany's reimbursement perspective. Plus the market is not as diversified in terms of treatment options in Europe compared to the US where in the US we see a much higher use of HMAs in second and third line which does not reflect what the European market so we see a bit of differences and primary test yeah and and just to be also address the revolutions point you made Steve I mean there is if you probably know that that is most European markets it is restricted to RS positive and I mean typically larger pharma you know has to think about their portfolio role especially protecting larger you know products like you know they're they're PD1s, we don't have that hindrance in the overweight. So we have a, you know, label that we can pursue, especially in an RS-negative patient population, orphan designation, HMAs are not as entrenched in Europe, older population. And as you know the clinical trial we had, iMERGE, was predominantly European, you think of a trial. So there's significant advocacy as well from the medical community wanting to see a Vitello available for that patient. All right. Very helpful. Congratulations on achieving profitability. Thanks. Thank you. I show no further questions at this time. I'd like to turn it back to Harut Samerjan for closing remarks. Thank you to everyone joining our call today. We look forward to updating you on the progress in the next several quarters thank you this concludes today's conference call thank you for participating and you may now disconnect