GERN - NASDAQ

Hello, and thank you for standing by. My name is Tiffany, and I will be your conference operator today. At this time, I would like to welcome everyone to the Geron Q2 2025 Earnings Call. [Operator Instructions] I would now like to turn the call over to David Borah, Head of Investor Relations. David, please go ahead.

Good morning, everyone. Welcome to Geron Corporation's Second 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, therapeutic potential of RYTELO, anticipated clinical and commercial events and related time lines, 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. With that, I'll turn the call over to Dawn Bir, Interim President and Chief Executive Officer.

Thank you, Dave, and good morning to everyone on the call. I'll begin on Slide 4. Earlier today, the company issued a press release announcing the appointment of Geron's new President and CEO, Harout Semerjian. He has joined today's call and will provide brief comments before we open the call for Q&A. I'm also joined by several members of our management team: Michelle Robertson, our Chief Financial Officer; Jim

Thanks, Dawn, and good morning, everyone. Today, I will provide a second quarter commercial performance and progress update. Quarter-over-quarter demand growth in the second quarter was 17% higher compared to the first quarter. These promising second quarter results were delivered by our cross-functional team that is executing our plan of action. I want to acknowledge the sales leadership team for focusing on leading their teams and delivering results, all while recruiting, hiring and training our expanded sales force. Our field teams are working together to transition accounts and relationships during this period of expansion and change. Looking forward, we expect the expanded team and planned initiatives to begin having an impact by year-end. In addition to the net revenue and demand growth metrics, we are pleased to provide updates across previously reported performance indicators on Slide 7. At the end of the second quarter, there were approximately 1,000 sites of care that have utilized RYTELO launched to date. This is an increase of approximately 400 new sites since the beginning of the year. Of the accounts that previously ordered, approximately 2/3 have reordered in the second quarter. The rolling 3-month claims data as of May 2025 estimates that approximately 30% of RYTELO new patient starts were in first and second lines. As HCPs gain clinical experience with RYTELO, we expect use in earlier lines to increase. Over time, we also expect our focus and execution on the commercial plan of action to support our efforts to increase use in earlier lines. We are encouraged by our recent market research that shows that when HCPs who treat lower-risk MDS are informed about RYTELO, the majority indicate that they will prescribe RYTELO. We believe that when HCPs are aware and informed, their likelihood to prescribe is strong. Therefore, we must execute our plan to increase awareness and educate HCPs on RYTELO's strong product differentiation so their intent to treat translates into actual treatment decisions with RYTELO. Payer access continues to strengthen with approximately 90% of U.S. covered lives now under favorable RYTELO medical coverage policies that are consistent with the FDA label and/or NCCN guidelines. This is an increase from 85% reported in the first quarter earnings call. We are pleased with this strong level of access, especially among top national payers. We remain focused on the successful commercialization of RYTELO in the U.S. On Slide 8, I will reinforce our commercial strategies and plan of action to drive continued growth. Our first priority is to increase RYTELO brand awareness by increasing our presence and share of voice across HCP targets to treat the majority of lower-risk MDS patients. Last quarter, we announced an expansion of our customer-facing teams by more than 20% to improve our reach and message delivery, especially for higher decile HCPs to treat the greatest number of RYTELO-eligible lower-risk MDS patients. I am pleased to report that almost all of the commercial new hires, including key account managers, oncology clinical educators and regional marketers are now trained and deployed in the field, and we expect to see their impact by the end of the year. The hiring process was highly competitive, and we added very experienced and accomplished individuals that we expect to make a strong team even stronger. Some level of disruption is expected as we expand and regions and territories change. Our sales colleagues have demonstrated strong teamwork and communication to make these transitions as efficient and least disruptive as possible. We are also making incremental investments in the second half of 2025 towards community-based educational and outreach initiatives. These initiatives are designed to drive broad reach and awareness, especially for community HCPs who treat fewer lower- risk MDS patients and may not see a Geron team member as often. Our second priority is to improve HCP prescribing confidence and clarity by reinforcing RYTELO's strong therapeutic profile and product differentiation, especially focusing on second-line post ESA or ESA ineligible patients to drive earlier use aligned with our approved label. We believe RYTELO is a highly effective novel treatment with a strong label, favorable NCCN guidelines and broad U.S. payer coverage. We are also making incremental investments in omnichannel initiatives designed to expand the reach of our key marketing messages for lower-risk MDS treaters and complement the messaging efforts of our sales team. Our third priority is to generate stronger KOL support and advocacy through engagement and education. Increased KOL advocacy is essential to building broader support and use of RYTELO given the limited number of U.S. clinical trial investigators and patients who participated in the Phase III IMerge trial. Our newly formed regional marketing team is hired and beginning to work with top KOLs in developing and executing peer-to-peer and community-focused education initiatives to support appropriate use for RYTELO. In summary, our second quarter performance results reflect the strong execution by our cross-functional teams. Our patient-centric team has the conviction to help make RYTELO accessible for treatment-eligible patients, and in doing so, deliver continued growth over the coming quarters and years. While we remain focused on U.S. launch performance, our three priorities in the EU remain HTA submissions, EAP programs and commercial distribution. Pending favorable pricing and reimbursement, we intend to take a measured approach to commercialization in select EU4 countries and do not plan to launch RYTELO in Europe independently. In the meantime, we maintain financial discipline in our investments for the planned EU4 launch. I will now turn the call over to Joe, who will provide a medical affairs and clinical development update.

Executive Vice President of Research & Development Thank you, Jim. I'd like to start with a general update of the medical affairs organization and highlight several important accomplishments from last quarter. During our last call, I mentioned the actions we are taking to enhance community awareness of RYTELO, improve HCP confidence in how and where to prescribe and bolster KOL advocacy within the lower-risk MDS HCP community. Both initiatives are being successfully implemented, and we are receiving positive feedback across the board from our external stakeholders. We have doubled the size of our overall medical affairs team. We expanded the team to concentrate on payer-focused MSLs and restructured our publication planning and health economics outcomes research processes. We have a more streamlined and coordinated account management process, which is more efficiently aligned between our medical science liaisons and commercial field teams. We are focusing on increasing HCP awareness of RYTELO, particularly in the community setting and in academic centers that were not part of the Phase III pivotal trial. We are increasing our efforts to educate and inform the U.S. prescriber community and key thought leaders. Subsequently, we are seeing deeper involvement with high-priority HCPs and MSLs and a broadening support of RYTELO within the MDS community. Switching now to the IMpactMF Phase III trial in relapsed/refractory myelofibrosis. The study is now over 95% enrolled, and we expect to complete enrollment before the end of the year. As a reminder, this is the first MF trial where overall survival is the primary endpoint. Therefore, the time line for interim and final analysis are tied to the number of death events. Based on current assumptions of death events, we expect the interim analysis to occur in the second half of 2026 and a final analysis in the second half of 2028. We will monitor the death events as the trial advances and make any changes to our assumptions on that basis. As we highlighted on our last call, we are very excited about the potential to expand imetelstat in this indication. We have several presentations at the most recent American Society of Clinical Oncology Annual Meeting and at the European Hematology Association Annual Congress, showcasing our progress with the myelofibrosis program and underscoring our confidence in telomerase inhibition as potentially transformative new mechanism of therapeutic action. We also had a handful of presentations highlighting new analysis on how RYTELO has the potential to deliver meaningful benefit across a range of low-risk MDS patients. Having a strong presence at venues like ASCO and EHA is an important priority for Geron's medical affairs strategy, and we were extremely pleased with the multitude of opportunities to highlight the incredible work the company is doing. We also plan to have a strong presence at ASH. With that, I'll hand the call to Michelle to review our Q2 financial results.

Thank you, Joe, and good morning, everyone. For detailed results from the second quarter, please refer to the press release we issued this morning, which is available on our website. As of June 30, 2025, we had approximately $433 million in cash and marketable securities compared to $503 million as of December 31, 2024. Total net product revenue and total net revenue for the 3 months ended June 30, 2025, were $49 million. As RYTELO was approved by the FDA in June of 2024, there was only approximately $780,000 of net product revenue in Q2 of 2024. Gross to net remained in the mid-teens percent from Q1 to Q2 within the range of previous guidance. The increase in RYTELO net revenues from Q1 to Q2 was driven by increased demand from new patient starts. As of June 30, 2025, our inventory was within our target range of 2 to 4 weeks. Research and development expenses for the 3 months ended June 30, 2025, were $22 million compared to $31 million for the same period in 2024. The change was primarily due to lower clinical trial costs associated with the decrease of activity in our IMerge MDS study after FDA approval of RYTELO in 2024 as well as manufacturing and quality costs that were capitalized in the current period now that RYTELO is approved versus being expensed in the prior period. Selling, general and administrative expenses for the 3 months ended June 30, 2025, were $39 million, roughly unchanged from the same period last year. For fiscal year 2025, we still expect our total operating expenses to be in the range of approximately $270 million to $285 million. This includes expenses associated with our continued investment in our RYTELO commercialization strategy, investment in commercial supply redundancies and post-marketing commitments as well as preparations to launch RYTELO in selected EU countries in 2026. Overall, we believe that Geron remains in a strong financial position to achieve our corporate objectives with access to additional debt funding through our Pharmakon loan agreement. With that, I'm pleased to welcome Harout, who will provide brief remarks before opening the call for Q&A.

Thank you, Michelle, and good morning, everyone. I'm thrilled to be joining Geron at this pivotal time as we accelerate RYTELO's promise to lower-risk MDS patients in need of new options. Over the last period, I was deeply impressed by the Geron team's commitment to the mission at hand from the Board of Directors to the management and team at large. I look forward to connecting with our analysts and shareholders soon after my onboarding. Thank you. And with that, we will open the call for questions. Operator?

[Operator Instructions] Your first question comes from the line Tara Bancroft with TD Cowen.

Congrats on a great quarter, and we also want to offer a very warm welcome to Harout. Great to see you. So my question is, if you can offer maybe how many active patients are now receiving RYTELO? And I understand that 30% of new patients have been in the front and the second line, but I'm curious how much of that 17% increase in demand during Q2 was from true second-line or frontline patients just to get an idea of any nearer-term new messaging and outreach impacts that you're seeing.

It's Jim

Okay. Yes. No, that makes sense. And so of that 17% increase in demand, you don't necessarily have that data for how many of those specifically are second line or frontline patients, just to confirm that?

Not accurate data. We have good projections, and that's why we do some of the market research and again, the syndicated data, which I shared on the call. Right now, the market sizing reports that we get suggest that first and second-line use is approximately 30%.

Your next question comes from the line of Peter Lawson with Barclays.

Jim, maybe just on the back of Tara's question, just how sustainable is that 17% quarter-over-quarter demand growth? And I have a follow-up.

Sure. Peter, we focus on our business drivers. The business drivers are new patient starts by line of therapy and duration of treatment. And as you know, for a product that's often approved in the relapsed/refractory setting, physicians tend to use it in later lines. As they gain confidence, they move it to earlier lines. And that's what I would suggest the market research data has shown us that over the past couple of quarters, the intent to prescribe is high, and we're seeing positive trends over the past few quarters of physicians using RYTELO more in the first and second line. And I just reported that it was 30% approximately in this last survey.

Got you. Is there any additional data points around this kind of KOL scientific advisory strategy like how many new KOLs were added into the efficacy group or other data points you can share with us?

Sure. Maybe I'll take the first part and then invite Joe to ask as well. So KOLs are critical to our strategy. Given the limited number of KOLs that participated in the trial, we have a very concerted and appropriate effort against the KOLs. So as an example, we've taken some incremental budget, and we're increasing our KOL engagement, speaker programs, initiatives at large conferences and congresses and efforts like peer-to-peer programs. We funded that, and they will be executed throughout the course of the year and into next year. And that's where we're placing a lot of our KOL efforts. Joe?

Executive Vice President of Research & Development Thanks, Jim. And Peter, to give you a little bit more of the color, we obviously are engaging with scientific leaders of all backgrounds and stature. So we have different tiering, if you will, where the engagement is also tailored to their interest, their needs and our interest. And in that case, we have speakers, we have advisory meetings. We have publications. We have study designs and feedback that we collect insights from these various thought leaders. And that allows us, one, to manage our strategy well to respond to their needs and their patients' need, but also allows us to set our clinical development strategy, our medical performance and make sure that we are responding to the needs and enhancing knowledge and awareness in the community at all levels with the community docs and academic physicians. And that's how we approach this from a medical point of view and clinical development.

Your next question comes from the line of Faisal Khurshid with Leerink Partners.

Allow me also to kind of extend my best wishes to Dawn and also welcome to Harout. So Jim, thank you for that overview of the commercial plan of action. Could I ask you to sort of comment on like diagnosing? Like what do you think was the biggest issue that held back the launch in like 4Q and 1Q? And then consequentially, which of the strategies that you've employed in 2Q do you think had the biggest impact in the quarter and then going forward through the year as well?

Faisal, this is Dawn. I'll jump in real quickly and then turn it over to Jim. So as I entered the role, we quickly pivoted and identified strategies that we really believe are going to make a difference in the long term. Number one, of course, is increasing awareness of our product. Number two is ensuring that there's real comfort and clarity in prescribing. And number three, it's really engaging that KOL audience and gaining their support and their advocacy. And so that quick pivot happened in March, and we're really pleased with what we're seeing today and really focused on moving forward. And so Q2 was really encouraging. We expect that the efforts that are in place today will really play out over the next couple of quarters, and we expect to see long-term consistent growth. And I'll turn it over to Jim to provide additional comments.

Thanks, Dawn. Just to build on Dawn's point and to share my confidence and enthusiasm going forward. On brand awareness, we conduct a lot of market research. What I can share with you is that when physicians are educated and informed about our product profile, there's a statistically significant difference in the brand perceptions along efficacy, safety, MOA. When physicians understand our product profile, their intention to prescribe is high. That gives us confidence. And we're starting to see that play out in some of the early data and the trends as we get hyper focused on our strategy and the execution. Just to note on execution, all credit to our customer-facing teams, the existing team, executing the existing plan of action delivered the results that we just reported in the second quarter. The impact of the incremental sales team as well as the incremental investments will play out by the end of the year and end of next year. So that gives me tremendous confidence that we can execute and we can deliver the results that we all expect.

Got it. And can I ask a follow-up on duration of therapy? Because I know you've kind of said in the past that it was sort of tracking a little bit below where you'd like to see it. And now you're seeing the kind of proportion of utilization in frontline and second line increasing nicely quarter-over-quarter. Do you have visibility on seeing that play out in duration of therapy quite yet? Or is that something that you sort of need to gather more data on?

Thanks. It's similar to my previous answer in the buy and bill, we don't get perfect physician and therefore, patient level data. So again, we use different market research methodologies, SP data and our patient chart audits to assess that. I'll state what is intuitive and obvious, but I think it's helpful. In our IMerge trial, we reported that the duration of treatment was 7.8 months. As you know, when physicians start a new therapy approved in the relapsed/refractory setting, they tend to start it in later lines. As you go from first to second, third line plus, not only does the number of patients generally decrease, but the duration of treatment or the duration of response tends to decrease. So remember, right now, the majority of our patients are third line plus. But as I reported, we're starting to slowly move into the earlier lines as physicians gain confidence with RYTELO.

Your next question comes from the line of Stephen Willey with Stifel.

Let me also extend a warm welcome to Harout. Just curious, maybe, Jim, if there's anything that you can qualitatively say about early 3Q demand trends. I know you provided some color here on early second quarter trends on the last call. Just wondering if there's anything that you can say here that maybe dovetails with some of the improvement in metrics that you're seeing.

Sure. Thanks for the question. So as you know, claims data is available weekly to syndicated audience. We rely primarily on our own internal sales data. And what we see in both sources of data is that there can be some week-to-week fluctuations, which is why we focus primarily on trends, rolling 4-week, rolling 8-week and increasingly rolling 13-week averages. Without sharing confidential information on the early trends, we have cautious optimism that we will continue to drive demand and execution going forward.

Okay. And then maybe just a quick question on myelofibrosis and enrollment. Has there been anything just rate limiting on the screen failure front? I guess if I look at ClinicalTrials.gov, I mean, you've got 200-plus sites that are open and activated. I think over the last 12 months, you've maybe enrolled about 80 patients or 25% of the trial. So is there a rate-limiting factor here in terms of just your ability to recruit patients into the study?

Executive Vice President of Research & Development I mean at this juncture, obviously, there are no further obstacles. Usually, you see a hockey stick shape of enrollment where most of the difficulties are seen in the beginning when you're opening sites, when staff are being trained, that's why you see the highest level of screen fail. But as you progress in the study, and we are now at the tail end of that study, you see awareness of the protocol, the nuance of the inclusion/ exclusion. So you see a drop in the screen failures. And we're seeing enrollment that is very strong to the point that we are very confident that this study will complete enrollment by year-end.

Your next question comes from the line of Gil Blum with Needham.

Let me also add my congratulations and love to Harout. So we kind of got up this question a little bit, but is there any anecdotes you can provide about the type of physicians that are currently prescribing RYTELO in earlier lines? Any particular features there, where they are, what their experience is like?

Sure. I can provide some anecdotal information. So consistent with our label, we get some utilization in the ESA in eligible patients. We also get earlier line use when physicians have prescribed and have had patient success previously in later lines of therapy. Joe, do you want to add anything?

Executive Vice President of Research & Development Yes. I mean, if I understood your question, I mean, we're seeing prescribers in the community and in the academic centers. And we're seeing that awareness improvement over time. And I've said that on prior calls, RYTELO is definitely a different class. It affects the disease, not just the symptoms. And we see the highest response from a hemoglobin point of view in the MDS therapeutic arena. So all of these are attributes that physicians and patients are obviously appreciating. And the more awareness and experience they have, the more progression we'll see to increase the prescription, but also the setting in terms of line of setting that these patients are being treated with RYTELO.

Maybe a quick follow-on. When you don't see retention, is there any explanation that you're receiving from those centers or they just kind of fall off?

Market research would suggest that some of the discontinuations might be from cytopenias, but we see that as an opportunity to further educate physicians. And then I guess what we're most excited about is some of our data generation efforts to really help educate these physicians with our own internal data as well as potentially real-world data going forward. So we're putting a significant effort to make sure that once we have a patient that they have the best chance for outcomes and patient success.

Your next question comes from the line of Emily Bodnar with H.C. Wainwright.

I'll also extend my welcome to Harout. I guess along the line of questioning with the first-line, second-line usage, I'm curious what you think is kind of a realistic split that you can get to with first-line, second-line usage first, third line? And if you have any, I guess, additional data you can discuss with what physicians are typically using ahead of RYTELO for those third-line use cases?

Sure. If I give you our expectation and percentages around first and second line, I'd be in danger of giving guidance. So what I would say is that consistent with products approved in the later line, it is our intent and our objective to make sure that consistent with label, we have appropriate use in first-line ESA ineligible patient population as well as ESA relapsed/refractory patients regardless of second line plus. In terms of data, the most common used treatment out there -- remains ESA. Of course, luspatercept continues to grow, especially in first line with the COMMAND data. But regardless, we think we have a highly differentiated product, which, again, consistent with label. We're going to compete for that ESA ineligible patient in first line and then the ESA relapsed/refractory patient because we believe we have a highly differentiated product. And again, as market research suggests, when physicians understand our product profile, their intention to prescribe is high, and it's our obligation to make sure that we pull that through in our execution.

Your next question comes from the line of Greg Harrison with Scotiabank.

I wanted to ask how you're thinking about the EU commercialization strategy? And if there are specific attributes you're may be looking for in a partner? And if you could also comment on the potential timing of an agreement that you may announce.

Great questions. Thanks, Greg. So I think maybe some context is helpful right upfront. Only about half of the products approved in the U.S. wind up commercializing ex U.S. Fundamentally, the biggest barrier is often the reimbursable rate that is achieved ex U.S. We're really no different. So our #1 commercial priority is to make sure we secure the highest possible reimbursable rate. And as you know, in Europe, it's a country-by-country and negotiating effort. So that's our top priority across the board. In terms of partners, we have engaged a number of different partners on every front, including HTA, EAP and distribution. In terms of commercialization itself, what I want to reinforce is we are maintaining financial discipline in our investments. We're not building out ahead. We're going to make sure that we have strong reimbursement in the countries that matter most. And we're engaged with a partner right now that could potentially help us commercialize in the EU4 and in additional countries and regions should we get that favorable reimbursement. And that's where we're spending all of our commercial effort right now, which is getting strong reimbursement.

Your next question comes from the line of Corinne Johnson with Goldman Sachs.

Maybe a couple from us. You mentioned that 30% of the patients were second and first line in May. I was wondering if you could contextualize for us where that came from, maybe like the prior time that you ran those metrics. And then I know you're recalibrating the sales team and you expect that to really start flowing through by year-end. But I'm curious what leading metrics you're following to kind of understand how that recalibration is translating to improved demand?

Corinne, thanks. The source for this is outlined in the slide itself. So what we're using is the same source. It's IQVIA claims data based upon a rolling 3-month average. I will remind everyone that there's a lag in this data. So we just got the latest data, which is met recently, which is how that number was calculated. So we use the same methodology, the same partner to assess the trends over time. In terms of the field force, I'm really excited about the -- okay. Great. I don't know where I lost you. So anyway, the sales force metrics that we look at, obviously, are sales performance at the regional and territory level. We look at, obviously, execution metrics like reach and frequency and calls on top targets and physicians.

That concludes our question-and-answer session. I will now turn the call back over to David Borah for closing remarks.

I'd like to thank everybody for their time and attention today, and we look forward to meeting with you all soon. Thank you.