Geron Q4 2024 Earnings Call Transcript

Quartr
Provided by Quartr
February 26, 2025

There are 13 speakers on the call.

Operator

Hello, and welcome to the Geron Fourth Quarter and Full Year twenty twenty four 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. I would now like to turn the conference over to Erin Feingold, Vice President of Investor Relations and Corporate Communications. You may begin.

Speaker 1

Good morning, everyone. Welcome to the Geron Corporation fourth quarter and full year twenty twenty four earnings conference call. I am Erin Feingold, Geron's Vice President of Investor Relations and Corporate Communications. I'm joined today by several members of Geron's management team: Doctor. John Scarlett, Chairman and Chief Executive Officer Michelle Robertson, Executive Vice President and Chief Financial Officer Jim Zigler, Executive Vice President and Chief Commercial Officer Doctor.

Speaker 1

Joseph Eid, Executive Vice President, Research and Development and Doctor. Faye Suller, Executive Vice President and Chief Medical Officer. Before we begin, please note that during the course of this presentation and question and answer session, we will be making forward looking statements regarding future events, performance, plans, expectations and other projections, including those relating to the launch, commercial opportunity and therapeutic potential of Rytello, anticipated clinical and commercial events and related timelines, the sufficiency of Geron's financial resources and other statements that are not historical fact. 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.

Speaker 1

Geron undertakes no duty or obligation to update our forward looking statements. With that, I'll turn the call over to Chip. Chip?

Speaker 2

Thanks, Aaron, and good morning to everyone on the call. Thanks for joining us today. 2024 was a terrific year for Geron and for Rytello, our first in class telomerase inhibitor. Rytello has a unique mechanism of action that represents a highly differentiated treatment with blockbuster potential in this high unmet need lower risk MBS population. The FDA approved Rytello in June of twenty twenty four for the treatment of certain lower risk MBS patients, including patients in the front line who are ESA ineligible, second line ESA relapse and refractory patients, and third line plus patients regardless of RS status across lines of therapy.

Speaker 2

In addition, in August of twenty twenty four, Rytello received favorable placement in the MDS MCCN guidelines, including a category one treatment recommendation in second line RS positive and RS negative patients regardless of prior treatment. We've also been pleased with further validation for Rytello in lower risk MDS in Europe, where the CHMP adopted a positive opinion in December recommending the approval of Rytello for the treatment of ESA ineligible and ESA relapsedrefractory NONDEL5Q adult patients with transfusion dependent anemia due to lower risk MBS. The European Commission is expected to make a final decision on our Ryteller marketing authorization application in the first half of twenty twenty five. Beyond lower risk MDS, our development efforts in myelofibrosis also continue to progress in 2024. We have now achieved eighty percent enrollment in our pivotal Imetelstat Phase III IMPACT MF trial in JAKI relapsedrefractory myelofibrosis.

Speaker 2

Many of you will recall this is the first myelofibrosis Phase III trial with overall survival as the primary endpoint. This study assesses the potential to alter the course of myelofibrosis with Imetelstat. Based on our current enrollment rate and number of death rates, we expect the interim analysis may occur in the second half of twenty twenty six, while we expect the final analysis may occur in the second half of twenty twenty eight. We believe that if this trial is positive, Imetelstat could transform the treatment landscape for this high unmet need relapsedrefractory myelofibrosis patient population that has such additional survival today and, in doing so, to potentially double the Rytella commercial opportunity. We're proud of these robust 2024 accomplishments.

Speaker 2

Since launching in The U. S. Lower risk MDS market beginning at the June, we've seen positive uptake of Rytello. In the fourth quarter of twenty twenty four, our second full quarter on the market in The U. S, we achieved $47,500,000 in Rytello net product revenue.

Speaker 2

Since product availability at the June 2024 and through year end, we achieved $76,500,000 in net product revenue, which exceeded our internal expectations. From a financial perspective, we ended the year with a strong cash position of approximately $5.00 $3,000,000 which we expect will enable us to reach profitability without additional financing if our internal sales and operating expense expectations are met. However, despite achieving this revenue in the first two quarters of launch, we have observed flat revenue trends over the last few months. As many of you will recall, beginning a few months into launch, we changed our commercial and medical affairs leadership. Jim Ziegler, our Chief Commercial Officer and Joe Eid, our EVP of R and D, will discuss their assessments and actions in more detail later in this call.

Speaker 2

Before I hand the call over to Jim, however, I want to reinforce our confidence in the potential commercial opportunity of Rytila, which is supported by robust clinical and scientific evidence that Rytila is a highly differentiated product. We believe that the compelling Phase III data, along with the favorable FDA label and MCCN guidelines, support Rytella's establishment as a standard of care for high end net need eligible lower risk MDS patients, particularly in the second line. Most importantly, many hematologists that we speak with have the same assessment. So, with that, I'll turn the call over to Jim for our commercial update. Jim?

Speaker 3

Thank you, Chip, and good morning, everyone. Today, I will address Q4 commercial performance and recent revenue trends, highlight our assessments and actions to focus on our key value drivers and thus help us realize the significant commercial opportunities we have with Rytello in this high unmet need patient population. As described previously by Chip, we achieved $47,500,000 in Rytello net product revenues in the fourth quarter twenty twenty four. This demand for Rytello was supported by strong payer access. Payers responsible for approximately eighty percent of The U.

Speaker 3

S. Covered lives have implemented medical coverage policies for Rytella that are consistent with the FDA label, clinical trials and or NCCN guidelines. New patient starts and duration of treatment are the key primary drivers of revenue. For duration of treatment, it is important to note that even the longest treated patients in the commercial setting are just sitting the median of approximately eight months observed in the Phase III IMerge trial. And our market research suggests the duration of treatment in commercial Rytella patients treated to date appears consistent with that observed in IMerge.

Speaker 3

However, with respect to new patient starts, we have observed flatness over the past few months. Specifically, even though we see Rytella being utilized across RS negative and RS positive first line ESA ineligible, second line ESA relapsedrefractory and third line plus patients, the majority of new patient starts have come from the third line plus patient segment with the second line new patient starts lower than our expectations. Our priority is to drive new patient starts across the breadth of population in our FDA label so that we are not niche to a third line treatment. We are particularly focusing on ESA relapsedrefractory RS negative patients where we believe Rytella's benefit are notably differentiated and where there is substantially unsatisfied patient population. There are other factors we are also addressing which we believe will help accelerate uptake in earlier line patients.

Speaker 3

First, below the national level trends, we see variability in regional, territory and account level performance. Some territories and accounts are performing very well and competing and winning at the local level. Other territories and accounts have opportunities for improvement where we are refocusing our support and sales training efforts. Second, we believe the lower risk MDS market is promotionally sensitive with time in front of the healthcare providers or HCPs being a key factor to changing their prescribing behaviors. We are taking steps to optimize our engagement with target HCPs.

Speaker 3

Joe will also highlight educational efforts by our medical affairs team to increase HCP awareness and education. We expect that as HCPs gain successful clinical experience with Rytello in later lines and often difficult to treat patients and as we work to raise awareness and increase engagement, they will choose Vitello in earlier lines of treatment. Third, as Chip mentioned earlier, our organization changed commercial and medical affairs leadership a few months into launch. We have a balanced sense of urgency and a thoughtful approach in implementing changes to quickly drive operational excellence and minimize launch disruption. We have augmented the team with experienced senior leadership to support these efforts.

Speaker 3

Don Wynne joined in October 2024 as Senior Vice President, Commercial Strategy and Operations. Prior to joining Geron, Dawn was at Gilead Sciences for almost twenty years and most recently served as Vice President, Commercial Operations where she led a team of approximately 150 people responsible for supporting The U. S. Business. Dawn brings a deep background in commercial analytics to Geron.

Speaker 3

Jim Hassard joined in November 2024 as Senior Vice President Sales and Marketing. He is another strong commercial leader with a thirty plus year successful track record. His prior experiences include roles as Chief Commercial Officer at two publicly traded biotech companies after spending most of his career at Amgen in senior sales and marketing leadership roles, including a country manager role. Together, Don and Jim and their teams are working to improve insights, strategies and execution. We are also assessing other possible root causes for the flat revenue trends and have implemented or are in the process of implementing several changes such as scaling up our analytics capabilities, refining our segmentation and targeting and improving our promotional and sales force effectiveness, which we believe will help us more fully capture the significant commercial opportunity for Rytello in lower risk MDS, which I will speak to on the next slide.

Speaker 3

As shown on Slide eight in our earnings deck, we estimate that in 2025, the U. S. Rytello total addressable lower risk MDS patient population is approximately fifteen thousand four hundred patients and includes patients recommended in the NCCN guidelines. This includes approximately three thousand four hundred first line ESA ineligible patients, approximately seven thousand six hundred second line and four thousand four hundred third line plus patients with approximately seventy five percent of patients with RS negative and twenty five percent of patients with RS positive status. As I mentioned, our efforts are particularly focused on the eligible RS negative population where Ryceli is the only drug approved for ESA relapsedrefractory patients.

Speaker 3

Assuming the duration of treatment observed in IMerge and based on the current net price, there is potential to achieve blockbuster status by treating approximately one third of The U. S. Right fellow total addressable patients. I want to thank our dedicated commercial team and the cost functional teams at Geron for their hard work to ensure that treatment eligible patients have broad and timely access to Rytello. I will now turn the call over to Joe for a medical update.

Speaker 3

Joe?

Speaker 4

Thank you, Jim. And good morning, everyone. As Jim mentioned, we are excited about the opportunity to bring Rypella, an innovative and first in class drug, to as many eligible patients as possible. I joined GRAN in November. And working with the medical and commercial teams, we have now identified areas for improvement.

Speaker 4

Similar to Jim's approach in the commercial organization, we are continuing to build and enhance our medical organization. As a first in class drug with a unique mechanism of action, Rycala requires a steady flow of data to raise awareness and manage knowledge and data gaps at launch. To that end, we have actively prioritized our publication strategy and are targeting key medical congresses to reach the medical community to help increase awareness. Together with commercial, we are also investing in market development and KOL engagement, which is particularly important in this launch given that 70% of the Phase III IMerge investigators were ex U. S.

Speaker 4

At ASH in December, new analyses from IMerge Phase III were presented that are a good example of our proactive approach to bring data to the medical community to increase awareness, address potential knowledge gaps, and educate on key data that provide insights to physicians on how they can use Rytello in their clinical practice. The KOL engagement at ASH was robust and encouraging, and the data presented there reinforce Rytella's potential as a standard of care second line treatment for lower risk MDS patients regardless of prior therapy. In addition, the feedback we received at ASH has informed our plan to refresh our clinical development plan with the goal of generating data that will expand the application of Rytello in MDS and other potential indications and support our scientific engagements. I expect our market development activities, data generation and publication activities to make a positive impact as they continue to roll out. Before I turn the call over to Faye, as a hematologist who has treated MDS patients for many years, I'd like to share my excitement for Rytello.

Speaker 4

I believe Rytello is truly an innovative drug with a unique mechanism of action that will change how MDS patients are treated and managed. I will now turn the call over to Fei for clinical update. Faye?

Speaker 5

Thank you, Joe. And good morning, everyone. Today, I will provide an update on our ongoing myelofibrosis development programs. First, I will speak to our Phase three IMPACT MS clinical trial, the first with overall survival as the primary endpoint. We have conviction in this first of its kind trial based on significant Imhotel Fab clinical experience in

Speaker 4

myelofibrosis, starting

Speaker 5

with a pilot study out of Mayo Clinic, which was eventually published in the New England Journal of Medicine and was the basis for our phase two EMBARK study. In EMBARK, we enrolled participants with JAK inhibitor relapsedrefractory myelofibrosis to evaluate the efficacy and safety of two dose regimens of imetelstat, with overall survival as a key secondary endpoint. We found that the median overall survival in the nine point four milligram per kilogram arm compared favorably to historical controls, which are around eleven to sixteen months. To further validate the OI signal, we conducted a real world data study to compare best available therapy of closely matched patients in the Moffitt Cancer Center's database to the nine point four milligram per milligram in the Telestat arm in Embark. In this analysis, we found that leading over survival more than doubled versus those from best available therapy.

Speaker 5

This gave us the confidence to design a phase three trial, IMPACT MS, with an OS primary endpoint and two to one randomization, imetelstat to best available therapy. As Chip mentioned, this trial is now eighty percent enrolled. Based on the enrollment rate and death rates, we now expect the interim analysis from this study in the second half of twenty twenty six, and the final analysis in the second half of twenty twenty eight. This trial was designed to confirm the strong OS signal observed in the phase two study. And if the redoubt positively would be a paradigm shift and transformational for patients with JAK inhibitor relapsedrefractory myelofibrosis, who have limited treatment options and dismal survival.

Speaker 5

We are also sponsoring the Phase one IMPROVE NET clinical trial, from which we presented the first result at ASH, suggesting tolerability of Imetelstat combined with resolitinib as first line treatment in patients with myelofibrosis. We presented data from part one of the study showing that imetelstat was well tolerated with no dose limiting toxicities reported at any imetelstat dose level within the first twenty eight days of cycle one. The PK profiles of the metelstat and raflutinib in the study were consistent with previous monotherapy studies. Importantly, preliminary results showed variant allele frequency reductions in driver mutations associated with MS across all four dose cohorts. Additionally, patients treated with the metallostat nine point four milligram per kilogram experienced stable hematology values over time.

Speaker 5

And metallostat nine point four milligram per kilogram every four weeks was selected for dose confirmation and expansion. And we are actively enrolling patients in this part two of the study. Initial results from part two are expected in 2026. I look forward to continuing to keep you updated on our clinical development progress. And with that, I'll turn the call over to Michelle for a financial update.

Speaker 5

Michelle?

Speaker 6

Thanks, Faye, and good morning, everyone. For detailed Q4 and full year twenty twenty four financial results, please refer to the press release we issued this morning, which is available on our website. As of 12/31/2024, we had approximately $502,900,000 in cash, cash equivalents, restricted cash and marketable securities. Total product revenue, net for the three and twelve months ended 12/31/2024, was $47,500,000 and $76,500,000 respectively. There was no product revenue in the prior year period given that Rytello was approved by the FDA in June 2024.

Speaker 6

Total net revenue for the three and twelve months ended 12/31/2024, was $47,500,000 and $77,000,000 respectively, compared to $23,000 and $237,000 for the same period in 2023. Total net revenue includes license fees and royalties in addition to any net product revenue. Total operating expenses for the three and twelve months ended 12/31/2024, were $67,600,000 and $250,700,000 respectively compared to $54,300,000 and $194,200,000 for the same period in 2023. Cost of goods sold was approximately $783,000 and $1,300,000 for the three and twelve months ended 12/31/2024, respectively, which consisted of costs to manufacture and distribute Rytello compared to no cost of goods sold in the prior year period. Research and development expenses for the three and twelve months ended 12/31/2024, were $23,400,000 and $103,700,000 respectively and $32,900,000 and $125,000,000 for the same period in 2023.

Speaker 6

The decrease is primarily due to manufacturing and quality costs that were capitalized in the current period due to FDA approval of Rytello compared to being expensed in the prior period. The decrease is partially offset by an increase in personnel expenses related to increased headcount and incentive and stock based compensation expense recognized for the vesting of performance based stock options upon FDA approval of Rytello. Selling, general and administrative expenses for the three and twelve months ended 12/31/2024, were $43,400,000 and $145,700,000 respectively and $21,400,000 and $69,100,000 for the same period in 2023. The increase in general administration expenses in 2024 as compared to 2023 primarily reflects an increase in personnel expenses related to increased headcount to support the commercial launch of Rytaylo in The U. S.

Speaker 6

And stock based compensation expense recognized upon FDA approval of Rytaylo due to the vesting of performance based stock options. For fiscal year twenty twenty five, we expect total operating expenses to be in the range of approximately $270,000,000 to $285,000,000 which includes noncash items such as stock based compensation expense, amortization of debt discounts and issuance costs and depreciation and amortization. We expect to reach profitability without additional financing if our current internal sales and operating expense expectations are met. Based on our current operating plans and assumptions, we believe that our existing cash, cash equivalents and marketable securities, together with anticipated net revenues from U. S.

Speaker 6

Sales of Rytello, will be sufficient to fund our projected operating requirements

Speaker 2

for the foreseeable future. I will now turn the call back over to Chip. Chip? Thanks, Michelle. To close, we're very pleased with our accomplishments in 2024 in which we secured US regulatory approval for Rytello and lower risk MDS and commercially launched the product in June.

Speaker 2

We're confident that the strategic and leadership changes we put in place early in the launch combined with our differentiated product and the high end net need lower risk MDS population, will position us to increase our growth trajectory as these investments start translating to results. We also progressed to The U. S. Regulatory review process for imetelstat and lower risk MDS, which positions us to receive EU approval in the first half of twenty twenty five and potentially launch in select EU countries in 2026. Also, in 2026, we expect key readouts from our MF clinical programs with an expected interim analysis from Phase III impact MF in the second half of twenty twenty six as well as the primary analysis from Phase I improved MF in the same year.

Speaker 2

Lastly, we believe we're in a strong financial position, thanks to the non equity financings executed in November of twenty twenty four and the commercial opportunity of Raikelho in The U. S, which we believe position us to reach profitability without additional financing assuming we meet our operating expense and revenue expectations. While it is clear that we still have work to do to present Rytella as a strong treatment option in the patient populations where the needs are greatest and the potential patient benefits are clear, I and my colleagues are confident that refining our sales strategies and execution, investing further in our medical affairs functions, and continuing to increase awareness and engagement with HCPs and patients will will allow us to meet our goal of Rytello becoming a highly valued standard of care across treatment eligible, lower risk MDS patients. We will now open the line to questions. Operator?

Operator

Thank you. Your first question comes from Peter Lawson of Barclays. Your line is open.

Speaker 7

Great. Thanks. Thanks for the update. Maybe first question would just be around how we think about revenues, your commentary around flat revenues over the last few months, whether you're seeing any week over week growth. And I've seen that comment kind of captures January and February.

Speaker 7

And then the other component would just be around how we think about 1Q revenues themselves, whether that's flat or growing versus 4Q? And then anything you can tell us around revenues and costs as we think about 2025? Thank you so much.

Speaker 2

Thanks, Peter. Appreciate the question. So Jim will take this question, which obviously relate to both prior revenues and also for you had some questions about potential future revenues in the first quarter. So Jim?

Speaker 3

Good morning, Peter. So our revenues week over week have had some variability, but what I would say is our four and eight week rolling averages underscore the flatness that I characterized on the call. And that flatness continued into the prior week leading up to this call. So it may be a little bit too early to make a full call on Q1 revenues, but I would characterize and reinforce what we said on the earnings call that the past couple of months had been relatively flat week over week in the four and eight week averages.

Speaker 7

And anything you can say around this kind of costs or even revenues for 2025?

Speaker 3

Michel?

Speaker 6

I'm sorry, I didn't hear the question.

Speaker 7

Yes. Just any guidance you can provide around revenues for 2025 or indeed costs for 2025? Just kind of marrying up your comment around getting to profitability.

Speaker 6

Right. Yes. I mean, we have said that we're not providing guidance on the revenue just yet. We have always said that we wanted three or four quarters under our belt. And I think that just remains consistent with how we're going to talk about guidance for revenue.

Speaker 6

On the OpEx, we feel pretty good about our two seventy to two eighty five. We've got levers that we can pull, as well as stage gating expenses. So we'll manage that as the quarters go on. And right now, we have no changes to our forecast, our internal forecast around profitability.

Speaker 7

Got you. Okay. Thank you, Matt.

Speaker 2

Thanks, Peter.

Operator

The next question comes from Tara Bancroft with TD Cowen. Your line is open.

Speaker 8

Hi. Excuse me. Good morning and thanks for taking the question. So I was hoping you could give us maybe some more detail on the seasonality or patterns in general, not only that you're seeing with Rytella, but it appears to be impacting MDS as a whole with Luspatercept II. So I'm curious to get your thoughts on what's happening at a higher level in this indication.

Speaker 8

And then separately, maybe, Tim, if you could tell us more about the expected cadence of growth this year that we could see with your implemented changes that you suggested? Thanks so much.

Speaker 3

Sure. Thanks, Harry. Good morning.

Speaker 4

Sorry, Chip.

Speaker 6

No, go ahead.

Speaker 4

I had

Speaker 2

a detail on the seasonality and expected CapEx.

Speaker 3

Great. So we have started or we saw some seasonality beginning around the holidays, Thanksgiving more specifically. And there is some hesitancy in the market to start some of these products that require in our case some monitoring. So there was a little bit of a delay. I agree with you that as we've looked at other products in this market and ran correlations between our trends and others, there was a very high correlation.

Speaker 3

So it didn't just affect Rytello, it affected a primary product that's used in the space as well. In terms of the expected cadence, it's really driven off of our business driver, right? We characterize, the most important business driver for us is new patient starts. As you know, with launch products often start in later line, third line plus which we characterize on this call as seeing, that's where the majority of our use was even though we saw earlier line, second line, first line use. So, it really depends on our effectiveness in driving market share not just in third line plus but in earlier line second line and first line opportunities.

Speaker 3

And our expectation is that as we increase our share of voice, our reach and frequency and together with medical affairs increase the education and awareness, we hope to see, you know, greater impact and use across all lines of therapy. But it's not going to happen overnight. Share voice and increasing the prescribing behaviors will take some time.

Speaker 8

Okay, great. Thanks so much.

Operator

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

Speaker 2

Hey guys, on the trends

Speaker 9

that you've been seeing lately, could you comment on like how much of that was impact on new patient starts as opposed to like discontinuations or dose modifications and holidays? I guess the reason for the question is, like even if you're starting mostly in third line patients, right, like shouldn't you be kind of like adding patients at a consistent rate? And I guess like people are also wondering like the duration of therapy should still be longer than like the time you've been in the market in third line as well or is that not the way to think about it?

Speaker 3

Jim? Hi, Fossil. Good morning. No, I think the way you're thinking about it is exactly right. The primary drivers are new patient starts and duration of treatment.

Speaker 3

What I said on the call is that duration of treatment at this point was so early and that we're only approaching, you know, the median duration of treatment in IMERG about right now. That does not appear to be an issue based upon our own market research and KOL. As you know, there isn't perfect data that we can, you know, cite, the only, you know, data that we triangulate around. But right now at this point, we don't believe that duration of treatment is inconsistent with that seen in IMERG. And so, we have seen some softness and it's related to new patient starts.

Speaker 3

I think the way to characterize it is, you know, we saw uptake and unmet need and the treatment was really with some of these early adopters who believe who understood and believed in the product. And it's our obligation to really increase the region frequency, the share of voice amongst the majority of physicians who have yet to treat patients with Rytella.

Speaker 9

Got it. Thank you. And then in terms of like the inflection or potential inflection this year, you guys have visibility that you should be kind of like at a bottom on new patient growth now. And then like how confident are you that like the new sales strategy will cause an inflection and what kind of timing would should we expect on that?

Speaker 3

That's a great question. I wouldn't characterize it as an inflection. I think others characterized it in the past as a bolus. What we're looking for is steady growth, a steady growth in third line leading to earlier lines, second line and first line. So what we anticipate is that with great execution, great targeting, great messaging that as we increase our share of voice and awareness with these positions that we would see uptake across the board.

Speaker 3

Inflections are often associated with new indications, unique publications, things along those lines. So, right now, this is pure execution in order to increase market share and to begin to increase the adoption if you will across all lines of treatment.

Speaker 9

Got it. Thank you.

Speaker 2

Thanks, Hudson.

Operator

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

Speaker 9

Hi, good morning. Thanks for taking the question. What feedback are you getting from KOLs and other providers around why they're not using Ripello as much in earlier lines of therapy? And are there any differences based on studying as far as academic versus community? It sounds like from your comments just now that, the bulk of it may be in academic.

Speaker 3

Thanks, Greg. I think the first message that I would share with you is that our MD and our KOL feedback that have used Right Fellow very simply can be summarized as Right Fellow works. And we see that in our market research and our one on one engagements with the KOLs. I think the biggest opportunity for us is to really increase the region frequency, our education and awareness and share of voice especially as you point out with the community. I'll just give you a very simple, you know, mathematic equation.

Speaker 3

So, if you think about the fifteen thousand four hundred patients that we characterize as treatment eligible and you divide that by the number of MDS treating physicians in The U. S. It only leads to a couple of patients on average that each one of these physicians have. So it's really important for us to make sure that we get out to as many of these physicians in a cost effective way through our sales team, our medical affairs team and our non personal efforts to really increase the share of voice.

Speaker 7

Great. That's helpful. Thanks again.

Speaker 3

Thank you, Greg.

Operator

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

Speaker 10

Yes, good morning. Thanks for taking the questions. Can you guys maybe just comment a little bit on the patient mix that you've been seeing over the last couple of months, specifically in the second line setting, both with respect to RS status and prior therapy. And I guess, is it safe to say that given the majority of new patient starts are occurring in third line plus patients, does that imply that Rytella is primarily being sequenced post HMAs?

Speaker 2

Jim, you want to take that?

Speaker 3

Yes. Thanks, Steven. So, we haven't disclosed exact numbers. But what I could tell you is like most product launches, we're seeing higher use in later lines. But I would underscore that we're seeing utilization in both second line and first line as you point out.

Speaker 3

We have an opportunity to really sharpen our product differentiation especially in the RS negative patient population which many physicians will acknowledge that you know second line RS negative is one of the areas of high unmet need. I don't know that our messaging has been as specific as it could be and that's one of the things that we're refining with our segmentation targeting and messaging going forward. So we are seeing utilization across both RS positive and especially RS negative. I think we can have a greater uptake in RS negative given that that's about 75% of the underlying status.

Speaker 10

Okay. And then can you also maybe speak to some of the data that you're now contemplating generating to build on the value proposition of the product profile?

Speaker 3

Maybe I'll turn that to Joe. Joe, when said.

Speaker 4

Can you repeat the question please?

Speaker 10

Yes. Just wondering what data you're now contemplating generating to build on the value proposition of Ritella?

Speaker 4

Yes. I mean, so the first thing, we have to look at the existing data from the Phase III program, the IMerge, and respond to questions from physicians about the full spectrum of the benefit for patients from this drug. We are also looking at advancing within the knee MDS different lines of treatment, whether it's in the first line or sequencing or combination. So those are potential ideas that we are pursuing and we have investigators who are interested in collaborating with us. Beyond MDS, there's obviously the ongoing myelofibrosis Phase three program, where we're treating patients who are in the relapsedrefractory setting.

Speaker 4

But in parallel, we also have a first line in combination with the JAK inhibitor study that is also in the second part of that development. Beyond that, there are obviously many different areas that the mechanism of action is applicable that we are also looking at collaborating with investigators to advance right talent development.

Speaker 10

Okay. And then maybe just last question. I guess, is what is happening in The U. S, just given the flatness and the trajectory of new patient starts? And I know you're not looking to commercialize in Europe until 2026, but does that now kind of change the cadence of perhaps expansion plans outside of The U.

Speaker 10

S? Do you need to get The U. S. On track and kind of growing in a new patient start direction before you embark on anything outside The United States?

Speaker 2

Yes. Steve, it's Chip. I think that it would be very easy for us to put our hands on our hearts and say our number one, two and three focus is on The U. S, The U. S.

Speaker 2

Getting The U. S. On track, the patient starts on track, appropriate utilization throughout the areas of high unmet need. And we are absolutely taking care to look at a variety of different options and to start some of the pre work for Europe. But I think it would be very, very easy to say that our 90 plus percent of our focus is on The U.

Speaker 2

S. Right now.

Speaker 10

All right. Thanks for taking the questions.

Speaker 2

Thanks, Steve.

Operator

The next question comes from Ellie Bodnar with H. C. Wainwright. Your line is open.

Speaker 11

Hi, good morning. Thanks for taking the questions. I guess on the first one, in terms of new patient starts, are you mainly seeing prescribers who have already used Rytello kind of re prescribe it to new patients or is it mostly coming from new prescribers and new centers? And then maybe if you could comment a bit on what factors are contributing to the slower enrollment in myelofibrosis and potential for any guidance on when you expect to reach full enrollment? Thank you.

Speaker 2

Okay. So Jim, why don't you comment about the new patient starts and cadence there with various prescribers and then we'll ask Faye to comment on the enrollment.

Speaker 3

Great. Thank you. On new patient starts we're seeing, repeat prescriptions amongst the early adopters largely at many of the academic medical centers. In the community, it's a little bit more diffuse so there we're seeing more breadth than depth. But over time, as with other product launches, I accept that both breadth and depth will continue to grow especially as physicians gain clinical experience and success with Rytella.

Speaker 2

Thanks, Tim. And Faye, could you make a comment on sort of the gluances you see it for enrollment and how you I sort of judge that today. And Emily, if you want to refine that question for Faye, please feel free to do so.

Speaker 5

Sure. Thanks, Emily. We're talking about the enrollment in MYF 3,001 in, the Phase three, right? Right. In that study?

Speaker 5

Yeah. Okay. Just to be sure. So the, enrollment in the the phase three studies is proceeding along well and has been, you know, steadily and as expected. Is there

Speaker 11

Okay. Any, like, timeline you can provide for when you expect to complete enrollment?

Speaker 5

I don't think we've released that publicly, but I'll remind you also that, you know, the, interim analysis and and the final analysis projected dates are not dependent necessarily on the enrollment timing, but more on the event dates. So we can reach those, milestones without necessarily enrollment being closed.

Speaker 11

Got it. Okay. Thank you.

Operator

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

Speaker 3

open. Yeah. Hey, good morning and thanks for taking the questions. Maybe first on the flattening over the past few months, can you comment on exactly which month you started to see flattening? Was it the beginning of this year or was it the beginning of fourth quarter last year?

Speaker 3

Hi, Calvin. This is Jim here. I would say based upon the rolling for an eight week, we started to see right, let's call it around the holidays, Thanksgiving holiday going forward. We do see as you know in the weekly data a lot of variability which is why we incur more to the four and the eight week rolling averages. Got it.

Speaker 3

And, I appreciate the color here into the more usage, in the third line setting. But I'm curious to hear if there are any other specific subgroups of patients that are more heavily targeted by doctors. For example, is this mostly used in high transfusion burden

Speaker 4

patients?

Speaker 3

We don't have perfect data on that. So, a lot of it is gathered through market research. But as you know, based upon our indication statement, we stay consistent with that. As physicians gain experience, they have the ability to use physician discretion, medical justification in areas that may go beyond the label. Got it.

Speaker 3

Okay. And then one last one from me. You know, I think we've had that slide in your deck saying that, you know, there are 15,000 plus patients eligible, potential $1,000,000,000 plus in net revenue. Do you still stand by that $1,000,000,000 plus number? Yes.

Speaker 3

The bottom line is for physicians that have used Ritello and based upon our KOL feedback as well as market research, Rykdal works. It's that simple. It's our obligation and opportunity to help educate and increase awareness with a much broader group of physicians across the country, but we absolutely do believe in it. I think our opportunity is to also drive market development and KOL development as Joe highlighted. There's a significant opportunity for us to increase the awareness, therefore leading to initial trial.

Speaker 3

Initial trial will lead to reinforced success and broader use. It will just take a little bit of time. Okay, great. Thank you very much for taking the questions.

Speaker 2

Thanks, Kyle. Thank you.

Operator

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

Speaker 12

Good morning, everyone, and thanks for taking our question. So, we noted that the financial OpEx guidance remains unchanged. Maybe just as

Speaker 3

a strategic

Speaker 12

question, given you guys plan on investing more in outreach here, doesn't this affect your estimates as it relates to operational expenses for 2025? Thanks.

Speaker 3

Hi, Jim here. Potentially, right, if we kept the spend exactly the same and increased our non personal spend it would, but the way we've managed our budget is to reallocate based upon opportunities and directed our send by shifting funds within.

Speaker 12

All right.

Speaker 2

And maybe other thoughts on that. Sorry, I just want to make sure.

Speaker 4

I'm sorry.

Speaker 3

I didn't Go ahead with your second.

Speaker 2

Yeah. So, the question was related to the OpEx unchanged and Jim gave the commentary, that we were reallocating within various portions of our budget there. I didn't know if you had any other comment on our OpEx unchanged going forward.

Speaker 6

Yes. I mean, Gil, I guess what I can say is we had already accounted for in our budget for 2025 additional investments in medical affairs and some other programs that, that we didn't get to in 2024. So, we've got flexibility. Okay.

Speaker 12

And maybe as a follow on here, I know maybe this question was addressed previously, but just to better understand, people who go on Ritalo seem to stay on Ritalo at least up until what we would have expected from the IMerge Phase three.

Speaker 3

So, it's just

Speaker 12

convincing physicians that they should give it a try, is this where the problem is? Thanks.

Speaker 3

Yes, I'd actually expand upon that. You know, we have a lot of early adopters that we've seen prescribed and gained that success. There's a lot more patients and physicians that have not used Rytello. So, it's really us increasing the education, the awareness and driving that initial clinical experience. That's really where the opportunity is on new patients starts.

Speaker 3

It's continuing to drive the breadth and the breadth obviously leading to depth over time.

Speaker 12

All right. Thanks for taking our questions.

Speaker 2

Thanks, Phil.

Operator

This concludes the question and answer session. I'll turn the call to Erin Feingold for closing remarks.

Speaker 1

Thank you so much for joining us today. We appreciate your interest in Geron and look forward to keeping you updated.

Operator

This concludes today's conference call. Thank you for joining. You may now disconnect.

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Earnings Conference Call
Geron Q4 2024
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