GERN - NASDAQ

Hello, and welcome to the Geron Corporation Third Quarter 2025 Earnings Call. [Operator Instructions] I would now like to turn the call over to Dawn Schottlandt, Senior Vice President, Investor Relations and Corporate Affairs. You may begin. 

Good morning, everyone. Welcome to the Geron Corporation Third Quarter 2025 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 relating to the launch, commercial opportunity, and therapeutic potential of VYTELLO, anticipated clinical and commercial events, and related timelines. The sufficiency of Geron's financial resources and other statements that are not historical facts. Actual events or results could differ materially.  Therefore, I refer you to the discussion under the heading Risk Factors in Geron's most recent periodic report filed with the SEC, which identifies important factors that could cause actual results to differ materially from those contained in the forward-looking statements and our future updates to those risk factors. Geron undertakes no duty or obligation to update our forward-looking statements.  Joining me on today's call are several members of Geron's management team: Harout Semerjian, Chief Executive Officer; Michelle Robertson, Chief Financial Officer; and Dr. Joseph Eid, Executive Vice President of Research and Development and Chief Medical Officer. Ahmed ElNawawi, our Chief Commercial Officer, will be introducing himself at the beginning of Q&A.  Before handing the call over to Harout Semerjian, I'd like to say I'm truly energized to join Geron. This is a company that can change the lives of patients with blood cancers. The work ahead of us is real, but in my 3 weeks here, my confidence in our ability to deliver has grown every day. With that, I'll turn the call over to Harout. 

Thank you, Dawn, and good morning, everyone. I'm very excited to be hosting my first earnings call as CEO of Geron. On this call, we will provide a commercial overview, an update on medical affairs and our pipeline, and end with an overview of our financials. Three months ago, I joined Geron because I saw a company with real promise, a differentiated product that is effective, and it addresses a high unmet need in lower-risk MDS.  Over these past months, I've been deeply impressed by the strength and dedication of our organization. The culture here is patient-focused and resilient, giving me conviction that with improved alignment, we can build an execution-oriented organization that brings the promise of RYTELO to more lower-risk MDS patients.  Let me share 4 reasons that support our belief. First, RYTELO is a compelling drug. It has demonstrated meaningful efficacy in lower-risk MDS, and it is differentiated in its mechanism of action and clinical profile.  Second, lower-risk MDS is an area of high unmet need with few, if any, potential treatments being studied in the clinic that can provide the differentiation that RYTELO can as a telomerase inhibitor. There is a clear opportunity for RYTELO to be an important therapeutic option in lower-risk MDS.  Third, there is an opportunity to accelerate growth with the right strategy and improved execution. And fourth, the company is well capitalized. We have a strong cash position, which we believe is sufficient to support the robust commercial and medical affairs engagement needed to increase RYTELO utilization.  Now, let me provide you with an overview of our Q3 commercial performance. Net product revenue was $47.2 million for the third quarter. During the quarter, demand for RYTELO was down 3% compared to last quarter. New patient starts in the first and second line increased to 36% compared to 30% in Q2.  However, new patient starts did not offset the discontinuations we saw from patients using RYTELO in later lines. It is clear we have work to do on establishing RYTELO as a second-line therapy in eligible patients with low-risk MDS and educating HCPs on treatment management. Prescribing accounts increased by 15% in the quarter, with approximately 150 new ordering accounts added in Q3, expanding our footprint to 1,150 accounts.  Lastly, we completed the first shipment of RYTELO to Germany under a named patient early access program. We're preparing for the planned commercialization of RYTELO in select EU markets in 2026. Q3 was an important quarter for us as we took stock of what we need to do to ensure RYTELO reaches more patients.  We're assessing both internally across people, processes, messaging, and overall effectiveness, and externally with our customers to amplify partnerships and ensure the appropriate usage of RYTELO. We recently announced the addition of Ahmed ElNawawi as our new Chief Commercial Officer.  ElNawawi is an experienced commercial leader with an established track record of launching multiple global oncology products and leading commercial teams in both biotech and pharma. He brings a wealth of expertise to Geron to execute a strong commercial strategy to support RYTELO's growth.  With the recently announced additions to the executive leadership team, along with existing team members, we can realign to accelerate momentum and grow RYTELO. I'm confident we can realize the full value of RYTELO and build a bright future for Geron.  We believe Geron and RYTELO can be transformational in the lower-risk MDS space with improved execution. We have already identified 4 initial actions to step up our execution and support future revenue growth.  First, we need to substantially increase awareness for RYTELO among U.S. HCPs through a comprehensive, well-coordinated account plan. Our market research is clearly telling us that education is key to increasing usage in the appropriate patients. This is especially critical when an HCP prescribes RYTELO to the first few patients. Our field-based commercial and medical colleagues have sharpened their approach to customer engagement aimed at educating HCPs on how to use RYTELO, identifying the appropriate patients to start therapy, expanding reach into the community, sites improving conversions and retention, and effectively managing patients on therapy. We believe, over time, this push to increase awareness for RYTELO will grow our U.S. prescriber base and drive sales in the U.S. Second, we need to significantly and consistently increase our in-person and digital presence in hematology forums. We are just starting to do this through expanded relationships with U.S. KOLs and increased engagement with key patient advocacy groups. A good example of this would be Geron's efforts at this year's Society of Hematologic Oncology Conference in September in Houston. At the conclusion of this conference, we noticed a surge in engagement from physicians who participated in our multiple advisory boards and other engagement activities, with a positive change in Geron's external perception. We received anecdotal feedback that more physicians are beginning to shift their thinking on RYTELO, not just as a third or fourth line option, but as a therapy worth considering earlier. That shift won't happen overnight. But as we continue these efforts throughout 2026, we expect to see an impact on RYTELO utilization. Lastly, we're excited to expand our IST program with U.S. clinical sites and HCPs to address additional key medical questions about potential uses of imetelstat and the benefits of telomerase inhibition. The IMerge trial predominantly enrolled sites in Europe. We have work to do to collaborate with U.S. HCPs and give them opportunities for additional research with imetelstat. These initial initiatives are just the beginning as we expect to identify additional opportunities to improve execution in the near term. It is important to recognize that the pull-through of the improved execution to revenue growth will take time. As for the additional utility of RYTELO, we recently completed enrollment in our IMpactTMF Phase III clinical trial evaluating imetelstat in relapsed/refractory myelofibrosis. We currently project the interim analysis to occur in the second half of 2026, with the final analysis projected in the second half of 2028. Our base case is for the trial to run to the final analysis, as is the case for the majority of trials with overall survival as the primary endpoint. Should we see an opportunity to help patients with data from the interim analysis, we will be ready to explore the next steps rapidly. Success in myelofibrosis could double our addressable patient population. Finally, before handing it over to Joe, I want to reiterate my optimism in Geron's future. Our priorities are clear. We are working to maximize the impact of RYTELO for patients today while advancing our first-in-class telomerase inhibitor to benefit more people tomorrow. With that, I'll now hand the call to Joe to review clinical and medical affairs progress.

Thank you, Harout. On today's call, I will highlight our upcoming presence at ASH, medical affairs actions we have taken to improve RYTELO execution, including events at SOHO and investigator-sponsored research. And then I'll provide an update on our Phase III clinical trial in relapsed/refractory myelofibrosis. First, we had 5 abstracts accepted for ASH. The data feature a new clinical and translational analysis of imetelstat across lower-risk myelodysplastic syndrome and myelofibrosis. Two abstracts, including an oral presentation, will feature new analyses from the Phase III IMerge trial. The oral presentation offers insight into how early cytopenias observed with imetelstat are on target pharmacological effects and may be associated with treatment response, offering valuable context for interpreting treatment patterns and managing patient outcomes. This data will help us educate HCPs to better understand, anticipate, and manage these effects, helping to ensure patients are appropriately maintained on therapy. The other IMerge abstract highlights a 42-month landmark analysis of long-term outcomes from the trial. While the analysis was not prespecified, the totality of the data and the results of the landmark analysis suggest a favorable trend for imetelstat in overall survival, progression-free survival, and time to progression to AML compared to placebo. Both abstracts highlight the value of the unique mechanism of action of RYTELO in lower-risk MDS disease and its management. There will also be 3 additional posters, including data from the EMbark and IMproveMF trials in MF and the investigator-sponsored trial, IMpress, in high-risk MDS and AML. We plan to continue our medical engagement at ASH. We are planning an advocacy forum that is designed to bring together patient advocacy organizations and professional societies to raise awareness and provide education on lower-risk MDS and the use of RYTELO as a treatment option. This is the first event of this nature hosted by Geron. In addition, we are planning to engage with an increasing number of hematologists at ASH, both in one-on-one and group settings. These engagements help us convey new data to physicians as well as collect insights that can help refine our strategy. Our presence at ASH will build upon the primary medical affairs efforts taken this quarter that focus on 4 strategic initiatives: community site penetration, initiation of ISTs, awareness and education ramp-up, and KOL and advocacy alignment. We strongly recognize that in order for RYTELO to be successful, we need to be successful in the community setting, where approximately 80% of lower-risk MDS patients are treated. Last quarter, we described how we are focusing on increasing HCP awareness of RYTELO, particularly in the community setting, as well as academic centers that were not part of the Phase III pivotal trial.  Our team has been actively engaged with these sites directly at an important medical meeting. The expansion of our medical affairs field team has allowed us to refine our targeting model, better prioritize mid-disile physicians, and improve awareness among community sites. We continue to intensify our messaging via webinars and peer-to-peer educational efforts.  In our most recent awareness trial utilization tracking, we observed positive shifts in physician understanding of RYTELO's efficacy in terms of robust and durable hemoglobin response and appreciation of cytopenias being on target based on RYTELO's unique mechanism of action.  In parallel, we continue to support several investigator-sponsored trials exploring imetelstat in diverse hematological settings, including combination regimens and earlier line use, as well as real-world evidence. We expect that these independent studies will help build external validation and broaden the clinical and real-world evidence base for imetelstat. We observed high interest in investigating imetelstat in preclinical, clinical, and real-world evidence settings. We received a good number of proposals, and we decided to fund a number of these proposals that we expect to commence generating data in 2026.  We are also actively engaging with KOLs and advocacy groups to broaden the reach of RYTELO's data narrative. Our goal is to help key opinion leaders become ambassadors, reinforcing that RYTELO can be considered alongside existing therapies in earlier lines rather than a drug of last resort. These efforts are starting to yield early results. Post-engagement surveys suggest that physicians who initially expressed reservations about cytopenia now report a better understanding of the mechanism of action, dose adjustment strategies, and monitoring protocols.  Our data confirmed that physicians who have used RYTELO in practice view its profile more favorably than those who have not. As many of you know, the Annual Society of Hematologic Oncology meeting was a major touch point this quarter. Our team presented real-world case studies, translational biomarker data, and longer-term follow-up from earlier treated patients. The reception was constructive. Among key opinion leaders, we are seeing a growing perspective that RYTELO deserves a position as the #2 option for eligible patients with lower-risk MDS after standard CSA therapy, especially in certain high-risk subpopulations.  This is supported by the recently updated NCCN guidelines that now recommend RYTELO as a treatment for use in low-risk MDS patients with serum EPO over 500 ahead of HMAs. A central theme during the SOHO meeting was how RYTELO's use fits with luspatercept. We made the case that RYTELO and luspatercept can be complementary rather than mutually exclusive, i.e., that RYTELO does not need to displace luspatercept, which can be used sequentially or in stratified patient segments based on its approved label and NCCN guidelines.  This narrative struck a chord, and we believe it could help ease some of the challenges in physicians' minds.  On the clinical front, I am pleased to report that our IMpactMF trial is now fully enrolled with 320 patients from 26 countries. This is a Phase III trial in relapsed/refractory myelofibrosis and is the first MF clinical trial with overall survival as the primary endpoint. We expect to have an interim analysis in the second half of 2026 and the final analysis in the second half of 2028, subject, of course, to achieving the specified number of death events.  With a high bar set for the interim analysis, we are planning for the trial to conclude at its final analysis. This is typical for a trial with the primary endpoint of OS.  To close, our medical affairs and R&D teams remain fully aligned with our commercial team. Our combined efforts are focused on evidence generation, physician engagement, and data dissemination to support broader adoption of RYTELO in lower-risk MDS. I'll now turn the call over to Michelle to go over our Q3 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. As of September 30, 2025, we had approximately $420 million in cash and marketable securities compared to $503 million as of December 31, 2024. Total net revenue for the 3 months ended September 30, 2025, was $47 million compared to $28 million in Q3 of 2024. Gross to net increased from Q2 to Q3 due to increases in the Medicaid mix rate, fees from new GPO contracts, and returns from several customers where their supply of RYTELO had reached its expiration date.  As of September 30, 2025, ending inventory at distributors was on the high end of our range of 2 to 4 weeks. Research and development expenses for the 3 months ended September 30, 2025, were $21 million compared to $20 million for the same period in 2024. The change was primarily due to increased CMC and personnel-related expenses. Selling, general, and administrative expenses for the 3 months ended September 30, 2025, were $39 million compared to $36 million in Q3 last year.  The change was due to an increase in sales and marketing headcount and additional investments in marketing programs. For fiscal year 2025, we expect our total operating expenses to be between $250 million and $260 million, below our previously announced guidance of $270 million to $285 million. We continue to focus on efficiencies and prudently manage our spend while continuing to prioritize investments in our RYTELO commercialization strategy, commercial supply redundancies, and post-marketing commitments, as well as preparations to launch RYTELO in selected EU countries in 2026.  Overall, with our current cash and marketable securities and anticipated net revenues from expected U.S. sales of RYTELO, we believe that Geron remains in a strong financial position to fund projected operating expenses for the foreseeable future. I'll now turn the call back to Harout for closing remarks. 

Thank you, Michelle. In closing, I want to reinforce 3 key takeaways from this call. Number one, shifting physician behavior and building a brand in hematology takes time.  The urgency across our organization is understood, and we're fully committed to the patients who are depending on us. Number two, improving alignment and generating momentum, is our focus. And lastly, RYTELO is a drug that works. With the right execution, we believe it can be positioned for long-term success. We appreciate your support. Before we begin our Q&A, I'd like to hand it over to Nawawi, our new CCO, to say a few words introducing himself. Nawawi?

Thank you, Harout. Let me start by saying thank you for the opportunity to be part of that Geron team. I am halfway through my third week, and what I have seen through my one-on-ones and team meetings with the entire commercial organization is that we are deeply committed to patients. We have a drug, RYTELLO, that has the potential to address an unmet need in low-risk MDS patients. With improved alignment and our focus on driving operational excellence, I am confident we can grow revenue by delivering RYTELO to eligible patients.

Thank you, Nawawi. Operator, we're ready for Q&A.

[Operator Instructions]

Your first question comes from Tara Bancroft with TD Cowen. So I have one very quick one and then a real one. So the first one is just being, if you can perhaps, Michelle, give us a little bit more insight into the current gross to net that you mentioned increased this quarter. Wondering if the previous mid-teens range still applies or if we should amend that. And then, so demand being down 3% this quarter, it's nearly flat. But I'm curious to hear more about what drove that. I know you stated that discontinuities in later lines are a big factor, but I'm curious to hear if there were other headwinds that you can speak of this quarter that you observed, like reluctance to reorder or seasonality, but basically, looking for any outlook on those for Q4 that may perhaps be reversing?

Tara, thanks. Yes. So I believe that the mid- to high teens are still applicable for the forecast. What we did 1 year in, it's reasonable to review your launch assumptions, check the channel mix. And in our case, we had an increase in the Medicaid channel mix. So we've increased our reserves for those rebates. And going forward, that will kind of moderate itself. We did have some returns. So we also looked at our rate of returns and trued that up and adjusted that and increased that moderately. And then we did expand our GPO contract business. So we had some additional fees this quarter, and we'll see those going forward also. But we still feel confident that we'll be in the mid- to high teens going forward.

Tara, thanks for the questions. Yes, I mean, you'll see basically what we're doing a lot. There's a lot of resetting and making sure that we have a strong base going forward. Regarding your question about the demand side, I mean, it is at 3%. That's the accurate number. I agree with you. It's flattish, given that our base number of patients where we are, a few patients can make a difference one way or the other. So keeping that in mind, what we're seeing is that we are getting new patients, but the discontinuation of patients who existed or who came in on the brand, they're really later-line patients. And unfortunately, those patients are much more beaten up, and they don't stay on therapy for very long. So what we really want to make sure that we are doing is we're getting the right patients upfront in the early setting, and that's going to happen by really driving the education, the brand awareness and the additional actions we're taking beyond just sending in a rep, that's where we believe that by doing the surround sound, that can drive the right patients to start on therapy. And that's where we're saying we have work to do on that part, so that's the focus area that we have.

The next question comes from Stephen Willey with Stifel.

I guess you talked about the growth in ordering accounts, I think, 15% sequentially. Do we know anything about just the breadth of prescribing at this point and how many of those ordering accounts have either already written the script and/or are new to the brand? And I just have a follow-up.

Yes. Steve, thanks for the question. Yes, I mean we're pleased to see the continuous increase in the number of new accounts coming on board. So another 150 accounts have ordered RYTELO in this quarter versus last quarter. So that puts us this year to more than 500 new accounts ordering RYTELO versus last year. So the breadth of folks getting on board, we're pleased with that. I think the work we have is making sure the depth is there and the right patients are the ones who are being put, namely, earlier lines of patients. So repeat business was about 80% of accounts that have reordered in the last quarter. So we're pleased with that. So I think that's not our bigger challenge where we want to focus on is getting the breadth of patients, especially having the first patients, especially in the community, to really have a right start, we call it. So basically, get the right patient on, know how to manage effectively the first few patients, especially in the community setting. And that we believe will lead to a depth of prescription, which can really be helpful for patients. So that's some of our focus areas. The breadth of accounts is actually going in the right direction in terms of additional accounts over time, coming on board with RYTELO.

And then, do you have any idea what the average duration of therapy looks like at this point? I know you're talking about use primarily occurring in these later-line patients. I know the label calls for 6 cycles, I guess, at a minimum. I'm just curious what you're seeing, if anything, on the duration of therapy side.

Yes. Thank you, Steve. What we have said is that in the real world, we're seeing that the therapy duration is in line with IMerge in a similar patient population. So, keeping in mind that in IMerge, there were predominantly more second-line patients. And in the real world, there are more third, fourth, and fifth-line patients. That's where the difference is happening. So that's where we want to make sure that we continue to encourage physicians to use RYTELO in earlier lines of therapy to really mimic what we're seeing in IMerge and beyond because currently, it's apples to oranges and IMerge is most second line and in real world, it's more third, fourth line, which is shorter than that 8 months that we've seen in IMerge.

The next question comes from Corinne Johnson with Goldman Sachs.

This is Anubham on behalf of Corinne. Can you talk about the revised operating expense guidance for the year? Where are you finding the savings or the efficiencies in the budget? And what should we expect with respect to the OpEx cadence for the next year?

Yes. Thanks. So I mean, we're not giving guidance just yet for the 2026 full-year spend. But for 2025, in the past, I have mentioned that we have levers to pull, particularly around some of our CMC investment. And we've also slowed down just some of the infrastructure, organizational infrastructure investments related to IT systems, and we were able to pull in our full year OpEx this year to the $250 million to $260 million. So we feel pretty confident in those numbers.

The next question comes from Emily Bodnar with H.C. Wainwright.

I had one on your sales force. I believe a few quarters ago, you mentioned that you would have the sales force fully hired by the third quarter. So I'm curious if that's been completed. And also any commentary you can give on what metrics you're using to evaluate the sales force, and their impact on demand generation? And also, if you can give an update on your EU partner search, if that's still ongoing.

Thank you, Emily. Good question. So yes, we have reported last quarter that we have hired our field force. And I would say our customer engagement folks, because it was beyond just the commercial people; we also doubled our MSLs in the field. So both have been done in the last quarter. The training has happened over the summertime. And now we do have an effective customer engagement folks, both on the commercial side and also on the medical side. Where the focus has now been is not just on the number of bodies that we have, but on the effectiveness of all the customer-facing folks, and then with the head office people, to really be effective, to be outcomes-focused rather than activity-focused. So there is quite a bit of work happening in the background on the operational excellence type, and that's where I'm very excited with Nawawi coming on board and together with the rest of the ELT, that we really drive the appropriate uptake of RYTELO in the right patients. So that's regarding the sales force and the execution piece. Regarding the EU, we remain excited. I mean, we do have an approval in the EU, which really sets us apart, and we're very excited about that. We want to make sure that we're good stewards of our investments. That's where the focus at this point of our own internal efforts are on the U.S., obviously, for 2 reasons: the U.S. being the largest market, but also the fact that IMerge has had much more robust uses in Europe rather than in the U.S. So from our own efforts, we're focusing on the U.S., but then also making sure that we're having the dialogue with appropriate potential partners in Europe and beyond. The whole idea is that RYTELO, we believe, needs to be everywhere, helping patients across the world. We don't need to be everywhere as a Geron ourselves. So those conversations are happening as we speak. But we want to make sure that it's the right people, it's the right timing. We are always having the patient in mind. So we're pleased to start seeing that we have our first named patient sales happening in Germany, but we will make sure that it's really the appropriate setup whatever we come up with, especially now that we have half of the ALT is new and there's a reset that we're doing internally and ensuring that we have the appropriate conversations given how much collective partnership opportunities we have across the world. So stay tuned on that. That's ongoing, and we will update the market as we have new updates.

[Operator Instructions] Your next question comes from Faisal Khurshid with Leerink Partners.

Just wanted to ask if you could characterize your level of confidence that you figured out what the issues are and that you truly believe that awareness is the main lever to pull here. And then also, if you have any updated views on the timeline to see a return to growth here based on your efforts and expanded field force?

Yes. Thank you, Faisal. I mean, look, we will not be here if we don't have confidence. I mean, we have very high confidence. I personally have high confidence, and every leader who is here has high confidence, be it newly joined or folks who've been here and who really believe in RYTELO. So confidence is definitely there. It's a prerequisite, but that's not enough, Faisal. Positive thinking is not where we're going. We really are focused on the execution of key areas such as brand awareness. I mean, that's one of the prerequisites, in my opinion, at least, that we want to make sure that more and more hematologists, when asked, do you know RYTELO in lower-risk MDS. The answer is yes. We want to make sure that physicians know how to use it, be it in academic centers or be it in the community. That's why we're really increasing our search on the ISTs because having hands-on experience with a drug like RYTELO by our U.S. hematologists is an important aspect of what we do. At the same time, on the community level, we want to make sure that our community physicians who are dealing with all kinds of different hematology and oncology situations and lower-risk MDS might not be the largest pool of patients they have, but they are able to effectively select the right patients and put them on the right therapy, manage the first couple of cycles of the adverse events so that they can get to the efficacy that we've seen in IMerge and others. So from a confidence perspective, Faisal, we definitely have the confidence. But beyond the confidence, we do believe we have the right identification of the diagnosis and some of the key programs that are now in place, and we look forward to continuing to update the market on that. At the same time, we are saying that these things do take time. I mean, it just is. And there is nothing wrong with that. It does take time. So we want to be also very open in terms of these are not light switch moments. We have the cash, we have the people, we have the plans, and we look forward to updating you as we start expanding our demand.

And then, do you have a timeline that you're willing to kind of guide the Street? I don't know when we should expect growth.

No, we're saying at this point, this is a 2026 growth story, Faisal. And we are not giving any guidance at this point on our top line, but we look forward to that being something that we plan to tackle in the near future. So we're assessing at this point. But we think now we've put our heads down, get to work. And in 2026, this is a growth story over there. But we're not giving any specific guidelines in terms of is it's going to start growing on March 31 or April 15. That's not what we're saying. But we are very confident about the trajectory. And as you're seeing, I mean, this has been a very important quarter to really level set many of the things that we need to do to ensure that we're doing the right things and then over time, growing the demand appropriately.