Hello and welcome to the Geron’s First Quarter 2025 Earnings Call. [Operator Instructions] I would now like to turn the conference over to Ron Maldiver, Investor Relations. You may begin.

Good morning everyone. Welcome to the Geron Corporation first 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 related to the launch, commercial opportunity, and therapeutic potential of RYTELO, 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 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.

Good morning. Thank you, Ron, and thank you all for joining us. I'll begin on Slide 4. I'm joined today by several members of Geron's management team, Michelle Robertson, our Chief Financial Officer; Jim Ziegler, our Chief Commercial Officer; and Dr. Joseph Eid, our Executive Vice President of Research and Development. Let's continue on the next slide. I'll begin by stating that RYTELO U.S. commercial launch success is our number one corporate priority. RYTELO is a first in class novel telomerase inhibitor recently approved for the treatment of certain patients with lower risk MDS, a disease with significant unmet need. We believe that there is a large U.S. market opportunity for RYTELO and Q1 sales were not where we expect them to be. Q1 RYTELO net revenues were 39.4 million, down 8 million from Q4, while demand in the 13-week period through the week ending March 28th was relatively flat at +1% versus the prior 13 weeks. The lower quarter-over-quarter net revenue is due to the inventory drawdown among our distributors from Q4 into Q1. Michelle will address this in greater detail in our financial update. Personally, I stepped into this role, because I'm excited by the opportunity to bring this important medicine to eligible patients in the healthcare community, and together with this leadership team, execute on this commercial opportunity and drive value for all involved. Today, we'll share key factors that we believe have influenced the recent soft performance, as well as specific enhancements we've made and continue to make to support U.S. commercial success. We expect our increased commercial investments to bolster uptake across a broader group of prescribers and drive long-term demand. Since our last earnings call, we've performed an in-depth analysis of our commercial efforts with the current market, and we're focused on 3 key…

Thanks Dawn, and good morning everyone. Today, I will provide a commercial performance update and highlight key actions we have taken and are continuing to take to drive enhanced launch performance, as well as recent encouraging performance indicators that we are tracking. We believe RYTELO is a highly effective novel treatment that fills a significant need in an underserved therapeutic area. We also believe that RYTELO has a strong and differentiated product label, positive NCCN guidelines, and broad U.S. payer coverage. This is why we believe that we can reignite this launch with the plans that we are executing and maximize RYTELO’s potential in a market with considerable opportunities. On Slide 7, we outlined the estimated U.S. total addressable market for RYTELO at approximately 15,400 lower risk MDS patients based upon the label and NCCN guidelines. Today, most usage has been in the third line plus setting. Use in later lines often occurs until HCPs gain experience with the new therapeutic agent. There is significant opportunity for RYTELO to expand use in earlier lines of treatment, including first line ESA-Ineligible, and second line ESA-relapsed refractory patients. In Europe, we estimate that the EU4 total addressable market for RYTELO is approximately 80% of the U.S. Later in this call, Joe will provide an update on our ongoing Phase III relapsed refractory myelofibrosis clinical trial IMPACT MS with a planned interim analysis expected in the second half of 2026. Early pre-commercial planning, including market and landscape assessment is now underway. Our preliminary estimate for the U.S. total addressable market is approximately 10,000 JAK inhibitor relapsed refractory myelofibrosis patients, and the EU4 total addressable market is approximately 9,000 JAK inhibitor relapsed refractory myelofibrosis patients. We will provide commercial planning updates as we approach key IMPACT MS clinical and regulatory milestones. Our top corporate…

Thank you, Jim. I'd like to start by sharing several recent accomplishments from the medical affairs organization. Since our last earnings call, we've implemented steps to further support community awareness of RYTELO, develop HCP confidence in how and where to prescribe and generate KOL advocacy within the lower risk MDS HCP community. I'm happy to share that we are executing in our plan. We are growing our medical science liaison footprint to reach more accounts by aligning their territorial coverage with the anticipated expansion of our commercial field team. This effort should help us achieve more streamlined and coordinated account management. Our field team interacts with HCPs frequently and is aligned with our corporate strategy to reach and educate the lower risk MDS prescriber community and key opinion leaders. We've expanded the team with payer focused MSLs and bolstered leadership in both publication planning and [indiscernible]. In fact, we are in the process of doubling the size of our overall medical affairs team since our last earnings call. We have been focused on increasing executive engagement with key institutions and thought leaders to share our data, discuss research areas of interest, and collect insights to inform our strategy. We are pleased with the positive feedback we have been hearing in these meetings. Key opinion leaders are interested in RYTELO's unique mechanism of action and learning more about our data that suggests the potential for disease modification. As Jim noted, we are also focused on increasing HCP awareness of RYTELO, particularly in the community setting and in centers that did not participate in our Phase III pivotal trial, which enrolled the vast majority of patients outside of the United States. We are increasing our efforts to educate and inform the U.S. prescriber community and key thought leaders. We are also pleased…

Thank you Joe, and good morning everyone. For detailed results from the quarter, please refer to the press release we issued this morning, which is available on our website. As of March 31, 2025, we had approximately 457.5 million in cash, cash equivalents, restricted cash and marketable securities compared to 502.9 million as of December 31, 2024. Total net product revenue and total net revenue for the 3 months ended March 31, 2025 were 39.4 million. There were no products or net revenues in the first quarter of last year since RYTELO was approved by the FDA in June of 2024. As Dawn mentioned, Q1 RYTELO net revenues were down approximately $8 million from Q4, while demand in the 13-week period through the week ending March 28 was relatively flat versus the prior 13 weeks. The lower quarter-over-quarter net revenue is due to the inventory drawdown among our distributors from Q4 into Q1. As a reminder, revenue recognition occurs when specialty pharmacies, specialty distributors, and GPOs receive RYTELO. Gross to net was similar from Q4 to Q1 and did not significantly contribute to the quarter-over-quarter net revenue decline. As Jim mentioned, we are encouraged by sales trends since the end of Q1, as we had the highest month-over-month demand growth as of April 25 since last October, representing a 10% increase in the current 4-week period compared to the prior 4 weeks. Research and development expenses for the 3 months ended March 31, 2025 were 15.1 million compared to 29.4 million for the same period in 2024. The decrease was primarily due to lower clinical trial costs associated with the wind down of activity in our Phase III IMerge MDS study at the FDA approval of RYTELO in 2024, as well as manufacturing and quality costs that were capitalized in…

Thank you Michelle, and thank you all again for joining us today. We believe RYTELO is a differentiated product for the treatment of certain patients with lower risk MDS, a disease with high unmet need. The first quarter sales were modest by our expectations, and we don't believe this reflects the product's true commercial potential. I want to reiterate our top priority remains U.S. commercialization in making RYTELO part of the standard of care for eligible lower risk MDS patients. The Geron team is energized by this responsibility, and we believe that we've made and continue to make the appropriate investments to support the success of our U.S. commercial business. While it's still early, we're beginning to see a few promising performance indicators and are ready to make diligent and swift adjustments as needed to further improve upon our commercial execution. EU commercialization and access to imetelstat are significant Geron priorities. We are carefully balancing our desire to make this important medicine available to lower risk MDS patients in the EU with thoughtful and disciplined resourcing, allowing our team to focus on RYTELO's success here in the United States. And lastly, we're excited as we look towards the future. Our pivotal Phase III trial evaluating imetelstat in relapsed refractory MS patients with an overall survival endpoint, if successful and approved in this setting, could potentially double the commercial opportunity of RYTELO. We expect that the interim data analysis could occur as soon as the second half of 2026. We look forward to keeping you informed of our progress across all of these priorities and will now open the line for questions. Operator?

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

Hi, good morning. So, I'm hoping just with the inventory impacts potentially behind you, demand is improving in recent weeks and the increased number of commercial reps that you have out in the field and growing through Q3, can you help us understand how you're thinking about Q2 expectations and just the expected cadence for the year as to when these efforts can potentially lead to inflection in your view?

Hi Tara, it's Dawn Bir. Thank you so much for your question. Yes, we're excited about the future and the plans that we've put in place, so I'll allow Jim to address your question here.

Great. Hi, Tara. Good morning. In terms of Q1, thanks for acknowledging that inventory played a factor and explains the difference between revenues and underlying demand, which grew at about 1% Q1 over Q4. A lot of the changes that we are making and will make will start to have an impact now and going forward. Your specific question around the reps. We're adding the reps. We anticipate they will be in the field beginning in Q3, so we'll see their impact later this year. But a couple of the promising data points that we acknowledged on the call were the increase of approximately 300 new ordering sites Q1 over Q4, the 10% increase in growth of April over March; so, what we anticipate is continued momentum building into Q2 and sustaining throughout the year through 2025.

Okay, thanks so much.

The next question comes from Greg Harrison with Scotiabank. Your line is open.

Good morning. This is Teresa Vitale on for Greg Harrison. Thanks for taking our question. Just curious if you can comment on your commercial efforts to drive the assessment of efficacy for patients on this luspatercept to an earlier stage in order to help promote switching to RYTELO, and maybe what are KOL citing as their reasoning behind. Any hesitation in switching patients from standard of care and prescribing RYTELO and earlier lines of therapy.

Teresa good morning and thank you for your question. I think maybe to address your question, we'll start first with Jim, but I think Joe could provide a great perspective from the medical affairs point of view. So I'll let Jim kick this off.

Let's talk first about perceptions, behaviors, and results. We do something called ATU market research, awareness, trial, utilization. And it all begins with awareness. What we see in the market research is that when physicians are aware of RYTELO's product profile, they view it favorably compared to those that don't understand it, and that holds for both efficacy as well as cytopenia management. In our most recent ATU, we saw a nice shift of cytopenia management, especially among those that have used RYTELO being viewed as much more manageable than those that haven't used it. In terms of efficacy, one of the nice data points that we saw in the most market -- most recent market research is that the perceptions around second line RS negative has definitely shifted and increased as a source of product differentiation. The reason why I bring this up is first to acknowledge the messages delivered by the field force are resonating with the physicians. We expect to see those perceptions to translate into changes in behavior. The data point that I shared on the call, which is very positive, is that in the most recent data we had about 20% utilization in 1st and 2nd line, which is an increase over the previous results. These are all leading indicators for sustained growth, and I want to again acknowledge our customer facing teams, both the CAMs as well as the oncology clinical educators for delivering the message, because as we highlighted earlier, when the message is delivered there is impact.

Yeah, maybe to compliment Jim's answer, you specifically asked [indiscernible] luspatercept. Obviously, as we know in the IMerge study there was limited number of patients who had received luspatercept, given that it was in the early days of its approval. However, we did have subsequent trials that did include patients who have received luspatercept and we presented data at ASH last December that showed the activity of imetelstat, post CSA, post luspatercept, heavy transfusion burden, mutation burden, all these patients responded in a similar manner. There will be obviously more patients from the real world data that we are collecting that will be providing additional information about that specific topic. In terms of hesitancy, as Jim has mentioned and I reemphasize, physicians who are using imetelstat have experienced the positive benefit of this on their patients, and that is encouraging. The efficacy is somewhat unparalleled in the space where we're seeing robust hemoglobin rises and patients' quality of life improving.

The next question comes from Peter Lawson of Barclays. Your line is open.

Great. Thank you so much. Jim maybe you could walk through the inventory issue, was that due to a distributor kind of stocking in 4Q or just the dynamics there that we should be thinking about as the inventory been burnt through and do you think that's corrected?

Thanks, Peter. First, I want to acknowledge that there are several factors that contributed to the higher inventory first. Prior to the holidays, we were on a growth trend and so many of our SPs and SDs were using history to project the future going forward. So, as the trend started to flatten the inventory increased. Second factor, as we talked about before, was some level of seasonality that affected our product as well as other products in our category. And then the third thing is perhaps there was some anticipation of pricing or reimbursement issues, which is not specific to RYTELO, but that's all buy and build products. So, while the inventory was probably at the higher end, the range towards the end of the year, we did start to draw down that inventory, and that explains the difference between the drop in net revenues, yet the 1% increase in demand. Thanks for the question Peter.

Great. And you think that kind of stabilized kind of issues, I guess slower than expected pull through, and stocking, you think that's in a good spot for 2Q?

We do Peter, thanks. Yes.

Great. Okay, thank you. And then on the -- I think you mentioned like 1300 high priority HCPs, how many are currently covered by the field team? How frequently do they call and kind of where do you want that metric to be in the second half of this year?

Peter, we're not going to get the specifics, but certainly by increasing our field reps by 20%, which I previously stated that our field was 50%, we increased it to 60%, at least amongst the key account manager. That allows us to go deeper and with more frequency to our higher decile position. So in terms of the 1300, they are definitely on the target list and there are some more above and beyond that on the target list as well.

The next question comes from Gil Blum with Needham and Company. Your line is open.

Good morning everyone and thanks for taking our questions. So, maybe just one specific to treating physicians here. You mentioned the kind of feedback you've been receiving. Have there been any specific push-backs of physicians who are less interested and I have a follow on?

Going back to the market research, what I would say is for those specifically that were -- have not used RYTELO or not necessarily educated by our key account managers, some of the often cited barriers are cytopenias are not having patients. However, that number dramatically changes when you talk about those physicians that have treated and or know about RYTELO. So, we believe that continued reach frequency, delivery of strong messages, especially to our targeted accounts will start to change those dynamics. But what I would key in on is the fact that physicians that have used it and are aware of RYTELO have a much more favorable view of the product profile and the utilization patterns.

If I may add, actually we've had several engagements with physicians who have not used RYTELO, and the main reason that they haven't used it as Jim said, is they're not aware of the full potential or they have heard about the cytopenia. In those conversations we've had with many of those type of physicians. When we do discuss the mechanism of action and that the cytopenias are actually on target due to the mechanism of action, the whole attitude shifts and the potential for a disease modification drug for these patients does impact the physicians' thinking and potential utilization in their clinics.

So just to hone in on that message, would you say the main barrier -- energy barrier here is just to get physicians to start treating? Is that fair?

One second, Jim. When Reblozyl was launched, there was this so-called apathy among physicians converting from ESAs to luspatercept. To this day, we see patients in particular in the community setting on ESAs, even with high EPO levels over 500, all patients who have failed ESAs, that's been the pattern for 20 plus years in the clinics, and that's the reason for many of those barriers that we are seeing initially in luspatercept journey and some of that we're seeing for the imetelstat as well. Go ahead Jim.

Nothing to add. Thanks, Joe.

Quick one for Michelle. I see OpEx guidance has not changed even though you guys seem to be investing more in your sales-force. Is this going to continue or should we expect maybe a shifting more towards investment and G&A?

Yeah, thanks. We had said previously that we had some levers to pull, to maintain our OpEx guidance, particularly around some of our investment in inventory and manufacturing redundancy, and so we're going to be looking at all of that, but right now we have included all of the additional investment in commercial and medical, and we do not have to change our guidance.

The next question comes from Stephen Willey of Stifel. Your line is open.

Yeah, good morning. Thanks for taking the questions. Joe, I guess you talked about 900 accounts having ordered to date. Can you talk to, I guess, where those accounts fit within those prescribing buckets that you talked about, are these accounts mostly in that top decile representing 50% of diagnosed patients? And then how does that 900 split out between academic and community?

Stephen, thanks for the question. The majority of those accounts represented by the 900 are in fact on our target list. However, there are some that are not on our target list. In terms of the general split, it's reflective of the underlying dynamics, which is approximately one-third in the academic centers and two-thirds in the community. And what we expect going forward is that with increased personal and non-personal promotions and a focus on KOLs that we actually grow both simultaneously, but our focus is both. We are focused on both the academic as well as the community. Thanks for the question, Stephen.

Okay, and then can you also just comment in terms of what you're seeing with respect to luspatercept utilization in the frontline setting both in terms of RS positive and RS negative and do you have any sense that these patients are subsequently stepping through an ESA as a second line option, or is it just too early into the luspatercept frontline launch to have any real clarity here.

Thanks for the question. We do have that data. We've looked at it from a claims perspective. We haven't necessarily showed it, but I think what I could say is that we are seeing growth in the first line with luspatercept based upon the command data, and if that happens and continues to grow, we're expecting duration of treatment fairly consistent with their study. In terms of switch, we can't promote specifically post luspatercept, our labeled indication is ESA relapsed refractory or ESA ineligible. However, the NCCA guidelines is a bit broader.

The next question comes from Emily Bodnar with HC Wainwright. Your line is open.

Hi, good morning. Thanks for giving the questions. I'm curious for physicians who have used RYTELO and who are not reordering, which I believe you said was about one-third of them. Are there any particular reasons that you've heard for why? And maybe if you can comment on this continuation to date, kind of reasonings for those and if that's kind of in line with your clinical data expectations?

Yeah, thanks, Emily. So, in terms of dose eruptions, discontinuation based upon our patient chart audits and some of our market research, it appears largely that the commercial experience is reflective of the percentages seen in IMerge in our clinical trials. And what was the other part of the question?

For the one-third of HCPs, you commented did not reorder RYTELO, if you can provide any reasoning that you're hearing for that.

Nothing specific at this point. It could just be simply dose interruption due to cytopenia. As you know, in this buy and build market we don't get perfect patient level data. So, what we do is market research, patient chart audits, and we triangulate those insights and those insights seem to be consistent with IMerge. There aren't any new surprises in any of the data and market research.

Okay. And lastly, if you can comment on the improved MS data that [indiscernible], what differences should we be expecting versus the presentation at ASH?

Yeah, we have started the second cohort which is the established doses, which are the maximum tolerated doses of both drugs, which was a good surprise if you will, and there were less cytopenia seen in that cohort of patients. So, we are expanding and we're adding additional JAK inhibitors to the combination.

The next question comes from Kalpit Patel with B. Riley Securities. Your line is open.

Hey, thanks for taking the questions. Maybe first on the inventory part of this, Michelle I think you previously communicated that the distributors were maintaining 2 to 4 weeks of inventory in the channel. So, what's the day supply today, I guess, or at the end of first quarter. And then I have a follow up.

Sure, thanks, Kalpit. Yeah, so at the end of Q4, as we mentioned, it was on the higher side, so it was on the higher end of the 3.5 week and as of the end of Q1, it was on the lower end of [indiscernible] weeks.

Okay, makes sense. And then, at this point in the launch, are your new patients starts consistently exceeding the discontinuation, or are you starting to see some of those early patients who received imetelstat start to roll off and offset the new starts?

We don't have perfect data on this, again we use patient chart audits and mark to research in the buy and build market, the data isn't, at a patient-specific level, but I could tell you and generally speaking, if 80% of the patients that I described in the previous quarter were third line plus, the duration of treatment for subsequent lines of therapy tend to be shorter than what we often quote as the median 7.8 months, so your math is correct as they roll off, new patients starts have to fill the funnel and continue to drive. The promising data that I share on this call is that, based upon the most recent new patients starts number 25%, approximately 25%, and we're in 1st and 2nd lines. So, the earlier we move up in lines of therapy, we generally expect longer duration of treatment.

Okay, and then one financial question, you reported 19.8 million net loss for the quarter and had about 45 million in cash burn. Maybe walk us through what drove that incremental 25 million in outflow; was this, any capital changes or inventory build or something else?

Well Q1 cash burn is always higher due to payouts of bonuses and some early investment, yes, on the inventory side. That was front --

Got it, thank you.

The next question comes from Faisal Khurshid with Leerink Partners. Your line is open.

Hey guys, thanks for taking the question. I just want to ask about this 10% demand increase that you've seen in April. Could you comment on, sort of how sustainable you see that increase to be going forward and also like how reliably do you expect that it translate into like true revenue growth?

Thanks Faisal. It's a great question. It's one data point. It's a promising data point April over March. What I can tell you is that from a sales-force perspective in market research, delivering the right message to the right physician is leading to success. We saw the changes in perceptions that I described earlier. We're seeing at least this one data point of April over March growth. The key for all of us is to sustain that growth and build the momentum going forward. Our expectation is that as a team that we return to growth, based upon strong execution.

Got it, thanks.

That is all the time we have for questions. This concludes today's conference call. Thank you for joining. You may now disconnect.