Geron Corporation Price & Performance (GERN)

Therefore, I refer you to the discussion under the heading Risk Factors in Geron's most recent periodic report filed with the SEC which identifies important factors that could cause actual results to differ materially from those contained in the forward looking statements and our future updates to those risk factors. Geron undertakes no duty or obligation to update our forward looking statements. With that, I'll turn the call over to Chip. [indiscernible] Thanks, Aaron, and good morning to everyone on the call.

Thanks for joining us today. 2024 was a terrific year for Geron and for Ritello, our first in class telomeric inhibitor. Bartelho has a unique mechanism of action that represents a highly differentiated treatment with blockbuster potential in this high unmet need lower risk MDS population.

The FDA approved RITELLO in June of twenty twenty four for the including patients in the frontline who are ESA ineligible, second line ESA relapsed and refractory patients and third line plus patients regardless of RS status across lines of therapy. In addition, in August of twenty twenty four, Artello 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 RITELLO in lower risk MDS in Europe. Where the CHMP adopted a positive opinion in December. Recommending the approval of Ritello for the treatment of ESA ineligible and ESA relapsedrefractory, NANDAL5Q adult patients with transfusion dependent anemia due to lower risk MDS. The European Commission is expected to make a final decision on our right telo marketing authorization application in the first half Beyond lower risk MBS, our development efforts in myelofibrosis also continued to progress in 2024.

We have now achieved eighty percent enrollment in our pivotal Imetel Phase three IMPACT MF trial in JAKI relapsedrefractory myelosclerosis. Many of you will recall this is the first myelofibrosis Phase III trial with overall survival of [indiscernible] 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 RITELO commercial opportunity. We're proud of these robust 2024 Since launching in The U. S. Lower risk MDS market beginning at the June, we've seen positive uptake of Ritello 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 Ritello net product revenue.

Since product availability at the June 2024 and through year end, we achieved $76,500,000 in net product revenue, which exceeded [indiscernible] 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 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 Zeigler, our Chief Commercial Officer and Joe Ead, our EVP of R and D will discuss their Before I hand the call over to Jim, however, I want to reinforce our confidence in the potential commercial opportunity of Ritala. Which is supported by robust clinical and scientific evidence that Rite is a highly differentiated product. We believe that the compelling Phase three data along with the favorable FDA label and MCCN guidelines support RITELLO's establishment as a standard of care for high unmet 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?

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 Ritello in this high unmet need patient population. As described previously by Chip, we achieved $47,500,000 Ritello net product revenues in the fourth quarter twenty twenty four. This demand for RITELLO is supported by strong payer access. Payers responsible for approximately 80% of U. S. Covered lives have implemented medical coverage policies for Ritello 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, 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 three IMerge trial And our market research suggests the duration of treatment in commercial RITELO patients treated to date appears consistent with that observed in IMerge. However, with respect to new patient starts, we have observed flatness over the past few months specifically even though we see Ritelo being utilized across RS negative, and RS positive first line, ESA ineligible second line ESA relapsed refractory 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 and our FDA label, so that we are not niched to a third line treatment. We are particularly focusing on ESA relapsedrefractory RS negative patients where we believe RITEL is 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.

First, below the national level trend, 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. 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 Ritalo, in later lines and often difficult to treat patients And as we work to raise awareness and increase engagement, They will choose Brightello 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.

Don Wynne joined in October 2024 as Senior Vice President, Commercial Strategy and Operations. Prior to joining Geron, John 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.

Don brings a deep background in commercial analytics to Geron Geron. 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 country manager role.

Together, Don and Jim and their teams are working to improve insights, strategies and execution. We are also assessing other possible route causes for the flat revenue trend 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 Ricello in lower risk MDS, which I will speak to on the next slide. As shown on Slide eight in our earnings deck, we estimate that in 2025, the U. S. Ritello 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 eligible RS negative population, we're a RiceFellow is the only drug approved for ESA relapsedrefractory patients.

Assuming the duration of treatment observed in IMerge, and based on current net price, there is potential to achieve blockbuster status by treating approximately one third of The U. S. Ritalo 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 RITELLO. I will now turn the call over to Joe for a medical update. Joe?

Thank you, Jim.

And good morning, everyone.

As Jim mentioned, we are excited about the opportunity to bring Ritalo an innovative and first in class drug to as many eligible patients as possible. I joined Yaron in November and working with the medical and commercial teams we have now identified areas for improvement. 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, Lykala 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 three iMerge investigators were Ex U. S. At ASH in December, new analyses from IMerge Phase three 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 provides insights to physicians on how they can use Ritalo in their clinical practice.

The KOL engagement at ASH was robust, and encouraging and the data presented there reinforced Rytellus 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 plans to refresh our clinical development plan with the goal of generating data, that will expand the application of Ritalo in MDS and other potential indications, and support our scientific engagement. 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 Ritalo. I believe RITELLO 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 Faye for clinical update. Faye?

Thank you, Joe, and good morning, everyone. Today, I will provide an update on our ongoing myelofibrosis development program. First, I will speak to our Phase three EMPHASMS clinical trial. The first with overall survival as primary endpoint. We have conviction in this first of its kind trial based on significant MS HealthLabs clinical experience in myelthilbosis.

Starting 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 II ENBARQ study.

In ENBARK, we enrolled participants 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 OS signal, we conducted a real world data study to compare best available therapy of closely matched patients in the Moffett Cancer Center's database to the nine point four milligrams per kilogram in the Telstat arm in ENBARK.

In this analysis, we found that leading over survival more than doubled versus those from best available therapy. This gave us the confidence to design a Phase three trial in PACT MS with an OS primary endpoint. And two: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 the second half of twenty twenty six and the biennial 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 it's a readout positively it would be a paradigm shift and transformational for patients with JAK inhibitor relapsedrefractory myelofibrosis. Who have limited treatment options We are also sponsoring the Phase I IMPROVEMS clinical trial. From which we presented the first result at ASH suggesting tolerability of Imetelstat combined with refolitinib as first line treatment in patients with myelofibrosis. We presented data from Part one of the study showing that ImmemHealth was well tolerated. With no dose limiting toxicities reported at any Impostat dose level within the first twenty eight days of cycle one. The PK profiles of the mithelstat and arsolitinib in the study were consistent with previous monotherapy studies. Importantly, preliminary results showed varied allele frequency reductions in driver mutations associated with a mass across all four dose cohorts.

Additionally, patients treated with enetelstat nine point four milligram experienced stable hematology values over time. And Metoclastat nine point four milligrams per kilogram every four weeks were 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 And with that, I'll turn the call over to Michele for a financial update. Michelle?

Thanks, Faye, and good morning, everyone.

For detailed Q4 and full year 2024 financial results, please refer to the press release we issued this morning is available on our website. As of 12/31/2024, we had approximately $5.00 $2,900,000 in cash, cash equivalents restricted cash and marketable securities.

Total product revenue net for the three and twelve months ended 12/31/2024 with $47,500,000 and $76,500,000 respectively.

There was no product revenue in the prior year period given that Ritello was approved by the FDA in June 2024. Total net revenue for the three and twelve months ended December 3124, with $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 Total operating expenses for the three and twelve months were $67,600,000 and $250,700,000 respectively compared to $54300000.0194200000.0 dollars for the same period in 2023.

Cost of goods sold was approximately $73,000 and $1,300,000 for the three and twelve months ended 12/31/2024 respectively, which consisted of costs to manufacture and distribute Ritello compared to no cost of goods sold in the prior year periods. Research and development expenses for the three and twelve months ended December 3124 were $23400000.0103700000.0 dollars respectively and $32,900,000.0125000000 dollars for the same period in 2023.

The decrease is primarily due to manufacturing and quality costs due to FDA approval of Ritello compared to being expensed in the prior period.

The decrease is partially offset by an increase in personnel expenses related to increased headcount incentive and stock based compensation expense recognized for the vesting of performance based stock options upon FDA approval of Ritello.

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 and administration expenses in 2024 as compared to '23, primarily reflects an increase in personnel expenses related to increased headcount to support the commercial launch of Ritalin in The U. S. And stock based compensation expense recognized upon FDA approval of Ritalo due to divesting 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 non cash 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. Sales of Ritello, will be sufficient to fund our projected operating requirements 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 U. S. Regulatory approval for Ritello and lower risk MDS, and commercially launched the product in June. We're confident that the strategic and leadership changes we put in place early in the launch combined with our differentiated product and high unmet 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 process for Imetelstat in lower risk MDS, which positions us to receive EU approval in the first half of twenty twenty five and potentially launch and select EU countries in 2026.

Also in 2026, we expect key readouts from our MF clinical programs with an expected interim analysis from Phase three IMPACT MF. In the second half of twenty twenty six as well as the primary analysis from Phase one IMPRIVMF in the same year. Lastly, we believe we're in a strong financial position, thanks to the non and the commercial opportunity of Ritello in The U. S, which we believe position us to reach profitability without additional financing assume we meet our operating expense and revenue expectations. [indiscernible] While it is clear that we still have work to do to present RITEELO as a strong treatment option, in the patient populations where the need to 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 allow us to meet our goal of Ritello becoming a highly valued standard of care. Across treatment eligible low risk MDS patients. We will now open the line to questions. Operator?

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

Great. 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.

You're seeing any week over week growth And I've seen that comment and it captures January and February 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? You so much. Thanks, Peter. Appreciate the question. So Jim will take this question. Which obviously relates to both prior revenues and also for had some questions about potential future revenues in the first quarter. So Jim? Good morning, Peter.

So our revenues week over week have had some variability 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 have been relatively flat, week over week in the four and eight week averages. And if you can say around, it's kind of costs or even revenues for 2025?

Michelle?

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

Yes, just any guidance you can provide? Around revenues for 2025 or indeed cost for 2025? Just kind of marrying up your comment around again to profitability.

Right. Yes. I mean, we're we have said, that we're not providing guidance on the revenue just yet.

Have always said that we wanted three or four quarters under our belt.

And I think that that just remains [indiscernible] we feel pretty good about our $270,000,000 to $285,000,000 We've got levers that we can pull as well as stage gating expenses. So we'll manage that as the as the quarters go on. And right now, we have no changes to our forecast, our internal forecast. Around profitability. Got you. Okay. Thank you, Sumit.

Thanks, Peter. The next question comes from Tara Bancroft with TD Cowen.

Your line is open. Hi. Good morning and thanks for taking the question. 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 Ritello, but it appears to be impacting MDS as a whole with luspatercept two. So I'm curious to get your thoughts on on what's happening at a higher level in this indication. And then separately, maybe, Jim, 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. [indiscernible] Sorry, Chip.

No, go ahead. So, detail on the seasonality and expected cadence. Great.

So we had 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. So it didn't just affect Ritello, 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? Characterize the most important business driver for us is new patient starts. [indiscernible] 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 line and first line opportunities. Our expectation is that as we increase our share of voice, our reach in frequency and together with Matterport Bears increase the education and awareness, We hope to see greater impact and use across all lines of therapy.

But it's not going to happen overnight. Share of voice and increasing the prescribing behaviors will take some time.

Okay, great. Thanks so much.

We next question comes from Faisal Persis with Leerink Partners.

Your line is open.

Hey guys, on the trends 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 in holidays? I guess the reason for the question is even if you're starting most 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 the time you've been in the market in third line as well or is that not the way to think about it? [indiscernible] Hi, Faiza. Good morning. I think the way you're thinking about it is exactly right. The primary drivers are new patient starts and duration of treatment. What I said on the call is that duration of treatment at this point, while still early in that we're only approaching the median duration of treatments in iMerge about right now. That does not appear to be an issue based upon our own market research in KOL. As you know, there isn't perfect data that we can cite only data that we triangulate around. But right now at this point, we don't believe that duration of treatment is [indiscernible] With vaccine and iMerge.

So we have seen some softness and it's related to new patient starts. I think the way to characterize it is We saw uptake in 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 reach and frequency the share of voice amongst majority of physicians who have yet to treat patients with Rital.

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

I wouldn't characterize it as an inflection. I think others characterize it in the past as a bolus. What we're looking for is steady growth. 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 physicians that we would see uptake across the board. 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.

Got it. Thank you. The next question comes from Greg Harrison with Scotiabank.

Your line is open.

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

I think the first message that I would share with you is that our MD and our KOL feedback that have used Ritalo very simply can be summarized as Ritello works.

And we see that in our market research, in our one on one engagements with the KOLs. Think the biggest opportunity for us is to really increase the reach and frequency our education and awareness and share of voice especially as you point out with the community, just give you a very simple mathematical equation. So if you think about the 15,400 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.

Great. That's helpful. Thanks again. Thank you, Greg.

The next question comes from Stephen Wiley of Stifel.

Your line is open.

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 it safe to say that given the majority of new patient starts are occurring in the third line plus patients should that imply that Ritalo is primarily being sequenced post HMAs.

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. We have an opportunity to really sharpen our product differentiation, especially in the RS negative patient population, which many physicians will acknowledge that 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.

Okay. And then can you also maybe speak to some of the data that you're now contemplating generating to build on on the value proposition of of the product profile? Maybe I'll turn that to Joe. [indiscernible] Can you repeat the question please?

Yes, just wondering what data you're now contemplating generating to build on the on the value proposition of Ritello.

Yes. I mean, so the first thing we have to look at the exist Phase three program, the iMerge, And respond to questions from physicians about the full spectrum of the benefit for patients from this drug. Are also looking at advancing within the miMDS 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 III program. Where we're treating pay patients who are in the relapse refractory setting 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 white talent development.

Okay.

And then maybe just last question. I guess is what is happening in The U. S. Just given the flatness in 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. S. Do you need to get The U. S. On track and kind of growing in in a new patient start direction before you embark on anything outside The United States?

Yes. Steve, it's Chip.

I think that it would be very easy for us to our hands on our hearts and say our number one, two and three focus is on The U. S. Getting The U. S. On track, if patient starts on track, appropriate appropriate utilization throughout the throughout the areas of high unmet needs. And we are absolutely taking care to look at a variety of different options and start some of the prework For your I think it would be very, very easy to say that 90 plus percent of our focus is on The U. S. Right now. All right.

For taking the questions. Thanks, Steve.

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

Your line is open. Hi, good morning. Thanks for taking the questions. I guess on to the first one, in terms of new patient starts, are you mainly seeing prescribers who have already used Rite Hello kind of represcribe it to new patients or is it mostly coming from new prescribers and new centers? And then maybe maybe 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.

Okay. So Jim, why don't you comment about the new patient starts and and cadence there with various prescribers and then we'll ask Faye to comment on the [indiscernible] 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 diffused, so there we're seeing more breadth than depth. But over time, as with other product launches, I expect that both breadth and depth will continue to Geron, especially as positioned gain clinical experience and success with Ritalo. [indiscernible] And Faye, could you make a comment on sort of the good news as you see it [indiscernible] And how you sort of judge that today. And Emily, if you want to refine that question for Faye, please feel free to do so.

Sure.

We're talking about the enrollment in MYF-three thousand and one in the Phase three, right? [indiscernible] Yeah. Okay. Just to be sure.

So the enrollment in the Phase three study is proceeding along well and has been steadily and as expected Is there any like, timeline you can provide to when you expect to complete enrollment?

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

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

Your line is open.

Hey, good morning and thanks for taking the question. 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? Hi, Calvi. This is Jim here. I would say based upon the rolling four and 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 incurred more to the four and the eight week rolling averages.

Got it. 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 subgroups of patients that are more heavily targeted by doctors For example, is this mostly used in high transfusion burden patients?

We don't have perfect data on that. So 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. Okay. And then one last one for me. I think we've had that slide in your deck saying that 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. The bottom line is for physicians that have used RITECL and based upon our KOL feedback as well as market research, Ritello 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, initial trial will lead to reinforced success in broader use. It just take a little bit of time. Okay, got it. Thank you very much for taking the questions.

Thanks, Kyle. Thank you.

The next question comes from Gil Blum with Needham.

Your line is open.

Good morning, everyone, and thanks for taking our question. So we noted that the financial OpEx guidance remains unchanged. Maybe just as a strategic question, given you guys plan on investing more in outreach here. Doesn't this affect your estimates as it relates to operational expenses? 2025?

Hi, it's Tim 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 shift in funds within. [indiscernible] Sorry, I just want to make sure. I'm sorry, I didn't Go ahead with your second. Yes. So the question was related to the OpEx unchanged and Jim gave the commentary that we were reallocating within various Any other comment on our our OpEx and change going forward?

Yes. I mean, Joe, 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.

And maybe as a follow on here, I know maybe this addressed previously, but Just to better understand, people who go on Ritello seem to stay on Ritello, at least up until what we would have expected from the emerge phase three.

So it's just convincing physicians that they should give it a try. Is is this where the problem is? Thanks. Yes, I'd actually expand upon that. We have a lot of early adopters that we've seen prescribed and gain that success. There's a lot more patients and physicians that have not used Vitello. 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 patient starts. It's continuing to drive the breadth and the breadth obviously leading to depth over time. All right.

Thanks for taking our questions. Thanks, Joe.

This concludes the question and answer session.

I'll turn the call to Geron Feingold for closing remarks.

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

This concludes today's conference call.