Geron Q2 2025 Earnings Report

Geron EPS Results

• Actual EPS: -$0.02
• Consensus EPS: -$0.03
• Beat/Miss: Beat by +$0.01
• One Year Ago EPS: -$0.10

Geron Revenue Results

• Actual Revenue: $49.04 million
• Expected Revenue: $47.30 million
• Beat/Miss: Beat by +$1.73 million
• YoY Revenue Growth: +5,455.60%

Geron Announcement Details

• Quarter: Q2 2025
• Date: 8/6/2025
• Time: Before Market Opens
• Conference Call Date: Wednesday, August 6, 2025
• Conference Call Time: 8:00AM ET

Geron (NASDAQ:GERN), a late-stage clinical biopharmaceutical company, focuses on the development and commercialization of therapeutics for myeloid hematologic malignancies. It develops imetelstat, a telomerase inhibitor that is in Phase 3 clinical trials, which inhibits the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies for the treatment of low or intermediate-1 risk myelodysplastic syndromes and intermediate-2 or high-risk myelofibrosis. The company was incorporated in 1990 and is headquartered in Foster City, California.

Geron Q2 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Rytello net revenues rose to $49 million in Q2, a 24% increase over Q1, driven by new patient starts with inventory maintained at the targeted 2–4 weeks.
• Positive Sentiment: US commercial efforts expanded with a 20% larger sales force and doubled medical affairs team, boosting brand awareness and HCP prescribing confidence as new hires are now deployed.
• Positive Sentiment: Favorable payer coverage now reaches approximately 90% of US lives under policies aligned with the FDA label and NCCN guidelines, up from 85% in Q1.
• Neutral Sentiment: Geron is pursuing a measured launch strategy in select EU4 markets in 2026, contingent on securing favorable pricing, HTA submissions, and distribution partnerships.
• Positive Sentiment: The IMPACT MF Phase III trial in myelofibrosis is over 95% enrolled and on track for year-end completion, with interim overall survival analysis expected in 2026.

Presentation

[Operator]

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 twenty twenty five Earnings Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session.

[Operator]

I would now like to turn the call over to David Bora, Head of Investor Relations. David, please go ahead.

[Dave Borah, SVP - IR & Corporate Strategy at Geron]

Good morning, everyone. Welcome to Geron Corporation's second quarter twenty twenty five 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 Rytello, 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.

[Dave Borah, SVP - IR & Corporate Strategy at Geron]

Sharon undertakes no duty or obligation to update our forward looking statements. With that, I'll turn the call over to Dawn Beer, Interim President and Chief Executive Officer.

[Dawn Bir, Interim President, CEO & Board of Directors Member at Geron]

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

[Dawn Bir, Interim President, CEO & Board of Directors Member at Geron]

Joseph Eid, our Executive Vice President of Research and Development. Our top priority remains the successful commercialization of Rytello in The United States. We are executing with precision across our enhanced and aligned commercial and medical affairs strategies established this past quarter. We see that they're beginning to translate into measurable results and believe that we have implemented the right strategies that will drive continued commercial success. Q2 RITELLO net revenues were $49,000,000 representing an increase of approximately 24% over the first quarter.

[Dawn Bir, Interim President, CEO & Board of Directors Member at Geron]

This was driven in part by increased demand from new patient starts. At the end of Q2, our inventory remained within our target range of two to four weeks. Last quarter, we outlined new strategic plans to bolster Rytello sales growth in The US. I'm happy to share that the team has been productively executing those strategies and very quickly implementing important initiatives. Today, Jim and Joe will provide an update highlighting these recent and significant advancements.

[Dawn Bir, Interim President, CEO & Board of Directors Member at Geron]

Our first priority is to increase brand awareness among the highest decile of US hematologists treating the greatest number of eligible lower risk MDS patients. We have seen an increase in Rytello awareness, both aided and unaided, among those physicians treating LR MDS patients. This is driven by Geron's wide reaching and aligned commercial and medical affairs educational efforts. Our second priority is to ensure that physicians are not only aware of Rytello, but have a comprehensive understanding of how and where to prescribe confidently and successfully. We're pleased that our HCP market research in Q2 indicated a higher willingness to prescribe Rytello in the first twelve months of a patient's therapy aligned with the approved label and NCCN guidelines.

[Dawn Bir, Interim President, CEO & Board of Directors Member at Geron]

And our third priority is to expand US KOL support and advocacy through aligned messaging, education, and engagement efforts. By expanding our commercial sales force and customer facing roles by over 20% and doubling the size of our medical affairs organization, we believe that we're on track to achieve the KOL support warranted by Rytello's unique mechanism of action and differentiated therapeutic profile. Our new hires have completed training and are now deployed to educate and inform key accounts and HCPs. We expect to begin seeing their impact by year end. Jim will provide additional details on Rytello performance during the quarter.

[Dawn Bir, Interim President, CEO & Board of Directors Member at Geron]

While still early in our execution, we're happy with how our sharpened commercial strategy and focus is showing early signs of success. We continue to keep a close eye on demand and sales trajectories and expect to make any necessary adjustments to ensure Rytello is being adequately and appropriately prescribed. Turning now to our European strategy. We continue activities to support launch in select EU markets next year. Jim and Joe will provide additional details later during this call.

[Dawn Bir, Interim President, CEO & Board of Directors Member at Geron]

We are pleased with the recent enrollment momentum in the Phase three IMPACT MF trial and expect enrollment to be completed by year end. Today, Joe will provide more details on this trial, including recently presented data at several medical meetings. Lastly, in early March, I stepped into the role of interim president and CEO on request of the board of directors to lead the company at a critical time during the search for a new CEO. In less than six months, we quickly pivoted, resetting the path of the organization. We are confident that the important work that was done over the last two quarters now positions Geron for future success.

[Dawn Bir, Interim President, CEO & Board of Directors Member at Geron]

On behalf of Geron's board of directors, I'm extremely pleased to welcome and to announce the appointment of Harout Semerjian as Geron's new president and CEO. Harout is a seasoned commercial leader who brings more than thirty years of experience and focus within hematology and oncology and a vast network of deep relationships with important physicians and thought leaders in this space. I believe that Harout will complement Jeron's seasoned leadership team while leveraging his experience to drive shareholder value. I'll remain invested in and committed to Jeron's success as a member of the board of directors. I'll now turn the call over to Jim for a commercial update.

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

Thanks, Don, 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.

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

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 seven. At the end of the second quarter, there were approximately 1,000 sites of care that have utilized Rytello launched to date. This is an increase of approximately 400 new sites since the beginning of the year.

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

Of the accounts that previously ordered, approximately two thirds have reordered in the second quarter. The rolling three month claims data as of May 2025 estimates that approximately thirty percent of Rytello new patient starts were in first and second lines. As HCPs gain clinical experience with Rytello, 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 launch. We are encouraged by our recent market research that shows that when HCPs who treat lower risk MDS are informed about Rytello, the majority indicate that they will prescribe Rytello.

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

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 Rytella's strong product differentiation so their intent to treat translates into actual treatment decisions with Rytella. Payer access continues to strengthen with approximately ninety percent of US covered lives now under favorable Rytello medical coverage policies that are consistent with the FDA label and or NCCN guidelines. This is an increase from eighty five percent reported in the first quarter earnings call. We are pleased with this strong level of access, especially among top national payers.

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

We remain focused on the successful commercialization of Rytello in The US. On slide eight, I will reinforce our commercial strategy and plan of action to drive continued growth. Our first priority is to increase VITELLO 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 Vitello eligible lower risk MDS patients. I am pleased to report that almost all of the commercial new hires, including the 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.

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

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 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.

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

Our second priority is to improve HCP prescribing confidence and clarity by reinforcing Rytella'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 Rytello is a highly effective novel treatment with a strong label, favorable NCCN guidelines, and broad US payer coverage. We are also making incremental investments in omnichannel initiatives designed to expand the reach of our key marketing messages for lower risk MBS traders 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 Rytello given the limited number of US clinical trial investigators and patients who participated in the phase three IMerge trial.

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

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 Rytello. 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 Rytello accessible for treatment eligible patients and in doing so, delivered continued growth over the coming quarters and years. While we remain focused on US 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 EU four countries and do not plan to launch Rytello in Europe independently.

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

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.

[Joseph Eid, EVP - Research & Development at Geron]

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 RITELLO, improve HCP confidence in how and where to prescribe and bolster KOL advocacy within the lower risk MDS HCP community. Those 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.

[Joseph Eid, EVP - Research & Development at Geron]

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 Rightello, 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.

[Joseph Eid, EVP - Research & Development at Geron]

Prescriber community and key thought leaders. Subsequently, we are seeing deeper involvement with high priority HCPs and MSLs and a broadening support of Rytella within the MDS community. Switching now to the IMPACT MF Phase III trial in relapsed refractory myelofibrosis. The study is now over ninety five percent 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.

[Joseph Eid, EVP - Research & Development at Geron]

Therefore, the timeline 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 2026 and a final analysis in the 2028. We will monitor the depth 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.

[Joseph Eid, EVP - Research & Development at Geron]

We also had a handful of presentations highlighting new analyses on how Rytello 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 are 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 Michel to review our Q2 financial results.

[Michelle Robertson, EVP, CFO & Treasurer at Geron]

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 06/30/2025, we had approximately $433,000,000 in cash and marketable securities compared to $5.00 $3,000,000 as of 12/31/2024. Total net product revenue and total net revenue for the three months ended 06/30/2025 were $49,000,000 As Rytella was approved by the FDA in June 2024, there was only approximately $780,000 of net product revenue in 2024. Gross to net remained in the mid teens percent from Q1 to Q2 within the range of previous guidance.

[Michelle Robertson, EVP, CFO & Treasurer at Geron]

The increase in Rytello net revenues from Q1 to Q2 was driven by increased demand from new patient starts. As of 06/30/2025, our inventory was within our target range of two to four weeks. Research and development expenses for the three months ended 06/30/2025 were $22,000,000 compared to $31,000,000 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 RITELLO in 2024, as well as manufacturing and quality costs that were capitalized in the current period now that RITELLO is approved versus being expensed in the prior period. Selling, general and administrative expenses for the three months ended 06/30/2025 were $39,000,000 roughly unchanged from the same period last year.

[Michelle Robertson, EVP, CFO & Treasurer at Geron]

For fiscal year twenty twenty five, we still expect our total operating expenses to be in the range of approximately $270,000,000 to $285,000,000 This includes expenses associated with our continued investment in our Rytello commercialization strategy, investment in commercial supply redundancies and post marketing commitments, as well as preparations to launch Rytello in selected EU countries in 2026. Overall, we believe that Geron remains in a strong financial position to achieve our corporate objective with access to additional debt funding through our Pharmacon loan agreement. With that, I'm pleased to welcome Harout, who will provide brief remarks before opening the call for Q and A.

[Harout Semerjian, President, CEO & Board of Directors Member at Geron]

Thank you, Michelle, and good morning, everyone. I'm thrilled to be joining Geron at this pivotal time as we accelerate Rydellos 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.

[Harout Semerjian, President, CEO & Board of Directors Member at Geron]

And with that, we will open the call for questions. Operator?

[Operator]

Your first question comes from the line of Tara Bancroft with TD Cowen. Please go ahead.

[Tara Bancroft, Director & Senior Analyst - Biotech Equity Research at TD Cowen]

Hi, good morning and congrats on a great quarter. And we also want to offer a very warm welcome to Harut. Great to see you. So my question is, if you can offer maybe how many active patients are now receiving Rytello? And I understand that thirty percent 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? Thanks so much.

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

Hi, Tara. Good morning. It's Jim Ziegler here. As you know, in the buy and bill market, we don't get perfect data, so we rely upon different methodologies to assess new patient starts. This could include market sizing reports from syndicated agencies, our specialty pharmacy, as well as patient chart audits.

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

Based upon that, we estimate our number of new patient starts. So if you use some simple math because, we we don't have that data, of the 1,000 plus, accounts that have prescribed Rytella today, and, two thirds of them have reordered in this previous quarter, you know the minimum threshold is gonna be, 600 plus, patients. So we use methodologies, but we don't report it specifically because it's not perfect data.

[Tara Bancroft, Director & Senior Analyst - Biotech Equity Research at TD Cowen]

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

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

Not 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%.

[Tara Bancroft, Director & Senior Analyst - Biotech Equity Research at TD Cowen]

Okay. Great. Yeah. Thank you so much.

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

Thanks, Karen.

[Operator]

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

[Peter Lawson, MD - US Biotech Equity Analyst at Barclays Capital]

Great. Thanks so much. Thanks for all the updates. 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.

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

Sure. Peter, you know, 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 into earlier lines.

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

And that's what I would suggest that 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 Rytello more in the first and second line. And I just reported that it was thirty percent, approximately in this last survey.

[Peter Lawson, MD - US Biotech Equity Analyst at Barclays Capital]

Got you. Thank 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?

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

Sure. Maybe I'll take the first part and then invite Joe to ask as well. So KOLs are critical to our strategy. You know, given the limited number of KOLs that participated in the trial, we have a very concerted and appropriate effort against the KOL. 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.

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

We funded that, and they will be executed, throughout the course of the year and into next year. And that's where, you know, we're placing a lot of our KOL efforts. Joe?

[Joseph Eid, EVP - Research & Development at Geron]

Yeah. Thanks thanks, Jim.

[Joseph Eid, EVP - Research & Development at Geron]

And and, Peter, to give you a little bit more of the color, we we obviously are engaging with scientific leaders of all, you know, backgrounds and and stature. So we have, you know, different tiering, if you will, where the engagement is is also tailored to their interest, their needs, and our our interest. And in that case, we have, you know, speakers, and we have advisory meetings. We have publications. We have study designs and and and feedback that we collect, insights from these, various thought leaders.

[Joseph Eid, EVP - Research & Development at Geron]

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, you know, 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 And that's how we approach this from a medical point of view and clinical development.

[Peter Lawson, MD - US Biotech Equity Analyst at Barclays Capital]

Great. Thank you so much.

[Operator]

Your next question comes from the line of Faisal Hirshed with Leerink Partners. Please go ahead.

[Faisal Khurshid, Senior Research Analyst - Emerging Immunology at Leerink Partners]

Great. Thanks for taking the question. Allow me also to kind of extend my best wishes to Don, and also welcome to Haroot. So Jim, thank you for that overview of the commercial plan of action. Could I ask you to sort of comment on like diagnosing?

[Faisal Khurshid, Senior Research Analyst - Emerging Immunology at Leerink Partners]

Like what do you think was the biggest issue that held back the launch in like 4Q and 1Q? And then consequentially, which of these 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?

[Dawn Bir, Interim President, CEO & Board of Directors Member at Geron]

Hi, Faisal. This is Dawn. I'll jump in real quickly and then turn it over to Jim. So, you know, as I entered the role, we quickly pivoted and identified strategies that we really believe are gonna make a difference in the long term. Number one, of course, is increasing awareness of our product.

[Dawn Bir, Interim President, CEO & Board of Directors Member at Geron]

Number two is ensuring that there's real comfort and clarity in prescribing. And number three, it's it's really engaging that KOL audience and gaining their 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 q two 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 we expect to see long term consistent growth.

[Dawn Bir, Interim President, CEO & Board of Directors Member at Geron]

And I'll turn it over to Jim to provide additional comments.

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

Thanks, Don. Just to build on, Don'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.

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

That gives us confidence, and we're start 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 a 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 in the end of next year. So, that gives me tremendous confidence that we can execute and we can deliver the results that we all expect.

[Faisal Khurshid, Senior Research Analyst - Emerging Immunology at Leerink Partners]

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 front line and second line increasing nicely quarter over quarter. Do you have visibility on seeing that play out in duration of therapy quite yet?

[Faisal Khurshid, Senior Research Analyst - Emerging Immunology at Leerink Partners]

Or is that something that, you sort of need to, like, gather more data on?

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

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.

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

In our IMerge trial, we reported that the duration of treatment was seven point eight 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 Brightcalo.

[Faisal Khurshid, Senior Research Analyst - Emerging Immunology at Leerink Partners]

Thank you for taking the questions.

[Operator]

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

[Stephen Willey, Managing Director at Stifel Institutional]

Yes, good morning. Thanks for taking the questions. And let me also extend a warm welcome to Harut. 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.

[Stephen Willey, Managing Director at Stifel Institutional]

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.

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

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, you know, four week, rolling eight week, and increasingly, thirteen week averages.

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

Without sharing, you know, confidential information on on the early trends, we have conscious optimism that we will continue to drive demand and execution, going forward.

[Stephen Willey, Managing Director at Stifel Institutional]

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 clintrials.gov, mean, you've got 200 plus sites that are open activated. I think over the last twelve months, you've maybe enrolled about eighty patients or twenty five percent of the trial.

[Stephen Willey, Managing Director at Stifel Institutional]

So is there a rate limiting factor here in terms of just your ability to accrue patients into this study?

[Joseph Eid, EVP - Research & Development at Geron]

I mean, at at this at this juncture, obviously, there are no 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 are being trained, that's why you see the highest level of screen fail. But as you progress in this study, and we are now at the tail end of that study, you see, you know, awareness of the protocol, the, the nuance of the inclusion exclusion. So you see a drop in the screen failures.

[Joseph Eid, EVP - Research & Development at Geron]

And, we're seeing, you know, enrollment that is, you know, very strong to the point that we are very confident that this study will complete enrollment by year end.

[Stephen Willey, Managing Director at Stifel Institutional]

Alright. Thanks for taking the questions.

[Operator]

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

[Gil Blum, Senior Biotech Analyst at Needham & Company]

Good morning, everyone. And, let me also add my congratulations and love to Harut. So we kind of got at this question a little bit, but is there any anecdotes you can provide about the type of physicians that are currently prescribing Ratel in earlier lines? Any particular features there, you know, where they are, what their experience is like? Thank you.

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

Sure. I can provide some anecdotal information. So, consistent with our label, we get some utilization in the ESA ineligible, 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 wanna add anything? Yeah. I mean,

[Joseph Eid, EVP - Research & Development at Geron]

if I understood your question, I mean, we're seeing prescribers in the community and in the academic centers, and and we're seeing that awareness, improvement over time. And, you know, I I've said that on prior calls. Brightelo 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. And 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're seeing to, increase the prescription but also the setting in terms of line of setting that these patients are being treated with Ritalin.

[Gil Blum, Senior Biotech Analyst at Needham & Company]

Thank you for taking my question. Maybe a quick follow on. When you don't see retention, is there any you know, explanation that you're receiving from those centers, or, you know, they just kinda fall off? Thank you.

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

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, you know, potentially, real world data going forward. So, we're putting a a significant effort to make sure that once we have a patient, that they have the best chance for, outcomes and patient success.

[Operator]

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

[Emily Bodnar, Biotech Equity Research Analyst at H.C. Wainwright & Co.]

Hi.

[Emily Bodnar, Biotech Equity Research Analyst at H.C. Wainwright & Co.]

Good morning. Thanks for taking the questions, and I'll also send my welcome to Herou. 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 Rytello for those third line use cases? Thank you.

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

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, you know, 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, relapse refractory patients regardless of second line plus. In terms of data, you know, the the most common used, treatment out there is and remains ESA. Of course, luspatercept continues to grow, especially in first line with the command data.

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

But regardless, we think we have a highly differentiated product, which, again, consistent with label. We're gonna compete for that ESA ineligible patient in first line and then the ESA relapsedrefractory patient because we we believe we have a highly differentiated product. And, again, as market research says suggests, when physicians understand our product profile, their intention to prescribe is I, and it's our obligation to make sure that we pull that through in our execution. Thanks, Emily.

[Operator]

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

[Greg Harrison, Director - Biotechnology at Scotiabank]

Hey, good morning. Thanks for taking the question. Wanted to ask how you're thinking about the EU commercialization strategy, if there are specific attributes you're maybe looking for in a in a partner and and if you could also comment on the the potential timing of an agreement that you may announce.

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

Great questions. Thanks, Greg. So I think maybe some context is helpful right up front. Only about half of the products approved in The US wind up commercializing ex US. Fundamentally, the the biggest barrier is often, the reimbursable, rate that is achieved ex US.

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

We're really no different. So our number one 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 efforts. 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.

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

What I wanna reinforce is we are maintaining financial discipline in our investments. We're not building out ahead. We're gonna 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 EU for 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.

[Greg Harrison, Director - Biotechnology at Scotiabank]

That's helpful. Thanks.

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

Thanks, Scott.

[Operator]

Your next question comes from the line of Corrine Johnson with GS. Please go ahead.

[Corinne Johnson, Vice President at Goldman Sachs]

Thanks. Maybe a couple from us. You mentioned that thirty percent of the patients were second and first line in May. I was wondering if you can contextualize for us where that came from, maybe, like, the the prior time that you 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.

[Corinne Johnson, Vice President at Goldman Sachs]

But I'm curious what leading metrics you're following to kind of understand how, that recalibration is is translating to improve demand. Thanks.

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

Sure. Hi, Karine. Thanks. The source for this is outlined in the slide itself. So what we're using is, the same source.

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

It's IQVIA claims data, based upon a rolling three month, average. I will remind, everyone that, there's a lag in this data. So, we we just got the, latest data, which is met, recently, which is how that number was calculated. So we used the same methodology, the same partner to assess the, trends over time. In terms of the field force, I'm really excited about the

[Operator]

Ladies and gentlemen, this is the operator.

[Dave Borah, SVP - IR & Corporate Strategy at Geron]

Hi, Karine. Can you hear us?

[Jim Ziegler, EVP & Chief Commercial Officer at Geron]

Operator, can you

[Corinne Johnson, Vice President at Goldman Sachs]

hear us? Yeah. We just got you back.

[Dave Borah, SVP - IR & Corporate Strategy at Geron]

Hi, Corinne. Can you hear us?

[Operator]

Is the operator. We can hear you, David.

[Dave Borah, SVP - IR & Corporate Strategy at Geron]

Okay. Great. I don't know why I lost you. So, anyways, the the Salesforce metrics that we look at, obviously, are a sales performance, at the regional and territory level. We look at, obviously, execution metrics like reach and frequency and calls on top targets and positions. Hello?

[Operator]

Yes, thanks. That concludes our question and answer session. I will now turn the call back over to David Bora for closing remarks.

[Dave Borah, SVP - IR & Corporate Strategy at Geron]

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

[Operator]

Ladies and gentlemen, this concludes today's call. Thank you all for joining. You may now disconnect.

Participants

Executives

• Dave Borah, SVP - IR & Corporate Strategy
• Dawn Bir, Interim President, CEO & Board of Directors Member
• Jim Ziegler, EVP & Chief Commercial Officer
• Joseph Eid, EVP - Research & Development
• Michelle Robertson, EVP, CFO & Treasurer
• Harout Semerjian, President, CEO & Board of Directors Member

Analysts

• Tara Bancroft, Director & Senior Analyst - Biotech Equity Research at TD Cowen
• Peter Lawson, MD - US Biotech Equity Analyst at Barclays Capital
• Faisal Khurshid, Senior Research Analyst - Emerging Immunology at Leerink Partners
• Stephen Willey, Managing Director at Stifel Institutional
• Gil Blum, Senior Biotech Analyst at Needham & Company
• Emily Bodnar, Biotech Equity Research Analyst at H.C. Wainwright & Co.
• Greg Harrison, Director - Biotechnology at Scotiabank
• Corinne Johnson, Vice President at Goldman Sachs