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spk10: Good morning. My name is Rob and I will be your conference operator today. At this time, I would like to welcome everyone to the Geron Corporation's first quarter 2023 earnings conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, again press the star one. Thank you. Erin Feingold, Vice President, Investor Relations and Corporate Communications. You may begin your conference.
spk07: Good morning, everyone. Welcome to the Geron Corporation first quarter 2023 earnings conference call. I am Erin Feingold, Geron's Vice President of Investor Relations and Corporate Communications. I'm joined today by the following members of Geron's management team. Dr. John Scarlett, Chairman and Chief Executive Officer. Olivia Bloom, Executive Vice President and Chief Financial Officer. Dr. Fay Feller, Executive Vice President and Chief Medical Officer. And Anil Kapoor, Executive Vice President of Corporate Strategy and Chief Commercial 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 therapeutic potential and potential regulatory approval of Immatel-STAT, 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 Jerron's quarterly report on Form 10-Q for the quarter ended March 31, 2023, which identifies important factors that could cause actual results to differ materially from those contained in the forward-looking statements. Jerron undertakes no duty or obligation to update our forward-looking statements. Please refer to the press release and slide deck for today's call under events in the investors and media section of our website at www.geron.com slash investors for our first quarter 2023 financial results, as well as business highlights. The agenda for today's conference call will be as follows. Chip will provide introductory remarks. Faye will give a regulatory update, discuss key data accepted for presentation at ASCO and EHA, and provide a medical affairs update. Neil will highlight our progress and launch planning and provide an overview of the lower-risk MDS commercial opportunity, including physician insights and perceptions. Olivia will review first quarter 2023 financial results and current capital resources, and Chip will provide concluding remarks before going to a Q&A session. With that, I will turn the call over to Chip.
spk12: Chip? Thanks, Erin. Good morning, everyone. Thanks for joining us today. At Geron, we aim to transform the treatment of heme malignancies, which we believe will provide a significant, compelling commercial value proposition. In the Telstat, our first-in-class telomerase inhibitor is poised to become a highly differentiated standard of care in lower-risk MDS and in relapsed refractory myelofibrosis. In lower-risk MDS, this is based on our eMERGE Phase III data, which showed an unprecedented durability of transfusion independence, as well as the breadth of that Ti benefit across major MDS subtypes, including both RS positive and RS negative patients. No other drug we know of today can match this level of durability in this patient population. Imatelstat's activity in RS negative patients is particularly noteworthy because there is no approved agent today specifically for this patient population which represents about 75% of the patient opportunity in lower-risk MDS. In fact, these RS-negative patients generally are harder to treat compared to RS-positive patients and therefore critically require new treatment options. Unlike the current treatment options, Imatelstat has a novel mechanism of action as a telomerase inhibitor that confers strong clinical and molecular evidence for disease modification, as well as a well-defined safety profile of on-target cytopenias, seen in some patients that have limited clinical consequences. Fay will further discuss these data, which are featured in two abstracts accepted for oral presentation at EHA. Fay will also highlight another accepted EHA abstract that is based on patient-reported outcome data from eMERGE Phase 3. This abstract illustrates that compared to placebo, in a Telstat treated patients were more likely to have sustained meaningful improvement in fatigue and experience such improvements more quickly. Based on these compelling phase three data, we're on track to submit our new drug application to the FDA next month. The submission will include a request for priority review. Our goal is to be ready for a commercial launch in early 2024. We're planning for the US commercial launch to ensure broad reimbursement for Imatelstat and deliver a seamless customer experience to all stakeholders. Under Anil's leadership, we're taking a deeply integrated and cross-functional approach to prepare our product, the market, and our organization for commercialization, which Neil will elaborate on later in the call. After lower-risk MDS, Geron also has a significant follow-on indication in JAK-I relapsed refractory MF patients that's anchored by the first and only Phase III study that has a primary endpoint of overall survival. If that study reads out positively, we expect Imatelstat to become a transformational standard of care for these MF patients who today have very limited treatment options. We believe Imatelstat can address significant unmet needs for lower-risk MDS and relapsed refractory MF patients, leading to a potential total addressable market opportunity, or TAM, in the U.S. and EU of greater than $7 billion in 2033. About half of that TAM, or approximately $3.5 billion, is attributable to the lower-risk MDS indication. From a financial perspective, we have over $400 million on the balance sheet as of the first quarter close, which gives us the financial wherewithal to operate the company through the end of the third quarter of 2025. As such, we believe we're positioned to launch Imatelstat and lower-risk MDS, uncompromised by financial restraints. while also supporting the rest of our malignant hematology program, including the expected readout of our phase three overall survival study in relapsed refractory MF. I believe our unprecedented clinical data today, driven by our differentiated mechanism of action and potential for disease modification, together with a clear regulatory pathway, solid financial resources, and a highly experienced team, represent a winning combination to bring Imatelstat to the market as a potentially transformational treatment for patients. With that, let me hand the call over to Faye Feller, our Chief Medical Officer. Faye?
spk03: Thank you, Chip, and good morning to everyone on the call. First, as Chip mentioned, we expect to submit the new drug application in lower-risk MDS to the FDA next month. I'm deeply impressed by and appreciative of the tremendous teamwork of the preclinical, regulatory, clinical, and CMC teams to prepare the MDA. Next, We are very pleased that all of our submitted abstracts have been accepted at the upcoming ASCO and EHA Annual Meeting. The abstract for Emerge Phase III Top Line Results was accepted for oral presentation at ASCO on June 2nd and will be available on the ASCO website on May 25. The abstracts for EHA describe longer follow-up data on durability of transfusion independence, further evidence of potential disease modification, and favorable patient-reported outcomes in imetelstat-treated lower-risk MDS patients in eMERGE Phase 3. The abstracts were posted online this morning on the eHA website, and I will be covering their contents in my remarks. The first abstract, which was accepted for oral presentation at eHA, described not only the top-line results from eMERGE Phase 3 that were released in January of this year, but also new data, including an update to the rate of one-year transfusion independence. Specifically, with three months of additional follow-up, 21 of the 118 Imatelstat-treated patients versus one of 60 placebo-treated patients achieved one-year TI, representing 63.6% of 24-week TI Imatelstat responders. As stated in the abstract, the continuous TI for one year and longer represents substantial relief from transfusion-associated complications for this lower-risk MDS patient population. In addition, this abstract describes new data on the correlations of reductions in variant allele frequency, or VAS, to longer TI duration in imetelstat-treated patients. I'll discuss these data with the next abstract. This second abstract also was accepted for an oral presentation at EHA and provides further evidence of the disease-modifying activity observed in eMERGE Phase III with imetelstat. Of the 178 patients enrolled in eMERGE Phase 3, 22% of imetelstat-treated patients and 21.7% of placebo-treated patients had baseline cytogenetic abnormalities. A cytogenetic response, which is defined by either a reduction or complete disappearance of abnormal cytogenetic clones characteristic for MDS, was observed in 34.6% of imetelstat-treated patients versus 15.4%. of placebo-treated patients. Imatelstat-treated patients achieving 8-week TI, 24-week TI, and 1-year TI had VAF reductions of at least 50% that were statistically significantly greater compared to placebo for SF3B1, TET2, and DNM T3A mutations. Importantly, greater VAF reductions in SF3B1 mutation for Imatelstat-treated patients were correlated at a highly statistically significant level with increases in hemoglobin and longer TI duration. The AFSHC concludes that these data, taken together with robust rates of TI that are continuous and durable for imetelstat-treated patients, may indicate improvement of the ineffective erythropoiesis characteristic of low-risk MDS and suggest imetelstat may alter the underlying biology of disease in these patients. Moving along to the third abstract, which will be a poster presentation at EHA. Patients with low-risk MDS and anemia typically experience severe fatigue that negatively impacts overall functioning in daily life. Further, fatigue can also be commonly reported as a side effect of currently available treatments. In eMERGE Phase 3, an exploratory analysis of patient-reported fatigue was conducted using the FACET Fatigue Score, a validated 13-item patient questionnaire to measure the rate of deterioration or improvement of fatigue during treatment with imetelstat or placebo. Based on this analysis, imetelstat did not worsen the rate of deterioration in fatigue, and impressively, patients treated with imetelstat had greater clinically meaningful sustained improvement in fatigue compared to placebo. An improvement in patient-reported fatigue has not been previously reported with any other treatment for lower-risk MDF. Also, the median time to achievement of sustained meaningful improvement in fatigue was shorter for metelstat versus placebo. Finally, in the metelstat-treated patients, a significantly higher proportion of responders had sustained meaningful improvement in fatigue scores versus non-responders, consistent across 8- and 24-week TI and HIE. This association was not observed in placebo-treated patients. These data provide additional evidence for the multifactorial clinical benefit of Imatelstat treatment. Lastly, two Imatelstat abstracts submitted by Jaron collaborators have been accepted for presentation at IHA. The first, which will be presented in an oral presentation, covers a translational analysis from a subset of lower-risk MDS patients from eMERGE Phase II. The abstract concludes that low inflammatory features At baseline, an induction of an adaptive immune profile by Imatelstat are associated with TI response, suggesting that immune cell remodeling could contribute to hematopoietic activity of Imatelstat treatment. The second, which will be a poster presentation, features Imatelstat preclinical data in MS, in which the authors demonstrate that Imatelstat reduces H-TERD expression and telomere length and targets JAK-STAT signaling. particularly in CalR-mutated cells. According to the AFTRAC conclusion, the data proposed that CalR-mutated clones are highly vulnerable to imital stack treatment. Next, I will discuss our pivotal Phase III impact MF study, which is designed to enroll approximately 320 patients with myelofibrosis that is relapsed refractory to JAK inhibitor. Our Garon Clinical Operations team has been conducting on-site visits to clinical trial sites around the globe, and we consistently hear significant enthusiasm from investigators around IMPACT-MS, specifically as the first and only Phase III MF trial with overall survival as the primary endpoint. Additionally, we've been increasing our engagement with patient advocacy groups in the myelofibrosis space, who have also expressed excitement around the potential to extend survival in this JAK inhibitor relapse refractory population. Lastly, the eMERGE Phase III readout in lower-risk MDS has also spurred an additional wave of support about the potential of imetelstat in myelofibrosis. Under our current planning assumptions, we continue to project the interim analysis for IMPACT-MS to occur in 2024. Of course, because these analyses are event-driven and it is uncertain whether actual rates for enrollment and events will reflect current planning assumptions, the interim analysis may occur at a different time than currently expected. In addition to engaging in a strong scientific exchange related to Metelstat at ASCO and EHA, our teams are planning to have significant on-site presence to interact directly with the medical community. We have exhibit space at ASCO offering MDS disease state information and medical resources for our clinical trials to oncologists and other attendees. our medical affairs team is also participating in conferences such as those organized by the Oncology Nursing Society, Society of Hematologic Oncology, Association of Managed Care Pharmacy, and the American Society of Hematology to support and connect with a broad array of professionals who touch the lives of patients with lower risk MDS and myelofibrosis. I am very pleased that we have completed the initial hiring of the medical affairs field team. which includes senior field medical liaisons and oncology clinical educators. Experienced scientists and dedicated clinicians will be interacting with the medical community as ambassadors to champion the unmet needs of patients with lower risk MDS and MS. Their efforts are an important piece of our broad launch preparedness planning, which Anil will cover in his remarks, as well as providing an overview of the Immatel-Statt market opportunity.
spk09: Anil? Thank you, Faye, and good morning, everyone. As Chip mentioned, we believe Geron has a highly compelling commercial value proposition with the potential for Imitelstat to become part of the standard of care in low-risk MDS and MS. My comments today will focus on low-risk MDS, our first indication, given the proximity of potential commercial launch. At a future meeting, I'll discuss the market dynamics and significant potential for Imitelstat in MS. First, I would like to commend the tremendous effort across Geron as we prepare for a successful US commercial launch of Imitelstat. As Chip mentioned, our goal is to prepare Imitelstat, the low-risk MDS market, and Geron is an organization so that we can deliver a seamless customer experience to all stakeholders while ensuring broad reimbursement for the drug. This slide 18, for those who are not on the webcast, provides a high-level overview of our launch preparedness progress across many teams and functions within Jera. I'd like to highlight the progress being made across each of the preparation pillars as we continue to target commercial launch readiness in early 2024. First, with regards to preparing IMITEL Start for Launch, in addition to our regulatory submissions and trademark activities, We continue to build out a comprehensive and integrated clinical and economic value proposition messaging that conclusively outlines Immetelstat's benefits across key stakeholders. We also continue to make progress in our manufacturing and distribution readiness, including on our long lead time supply chain activities, state licensing and third party logistic efforts in order to facilitate efficient distribution of Immetelstat and smooth flow through the U.S. healthcare system. Second, with regards to preparing the market, we have extensive efforts ongoing to generate market insights from providers, patient, and payer perspectives that are informing our U.S. market access and commercial channel strategies as detailed in this slide's middle pillar. Third, we have built out the majority of the commercial organization and are continuing to build out the infrastructure and enterprise-wide functional capabilities. We plan to hire our sales force in a stage-gated manner aligned to our PDUFA date. As I mentioned, to inform our launch strategy and execution, we have a significant effort ongoing to deeply understand the U.S. low-risk MDS market. Over the next few slides, I'll share some recent insights from this research, which we believe support Geron's strong commercial value proposition. First, I would like to address the low-risk MDS patient experience. Low-risk MDS, as many of you know, is predominantly a disease of the elderly. Patients typically present with anemia and many experience no symptoms in the early stage of the disease. Over time, the disease continues to progress and the majority of patients develop symptomatic anemia. Supportive care, primarily red blood cell transfusions, remains an important component of patient's treatment, but exposes patients to insufficient correction of anemia and other risks, including alloimmunization and organ iron overload. Erythropoiesis stimulating agents remain the first-line treatment of choice in lower-risk MDS, with lenalidomide and hypomethylating agents, or HMAs, being used in some patients as well. There is a significant unmet need for new therapeutics in this setting, as patients typically fail frontline treatments, become dependent on frequent red blood cell transfusions, have poor quality of life, heightened risk of transformation to acute myeloid leukemia, and shortened survival. Most patients with low-risk MDS and symptomatic anemia receive ESA treatment. However, not all patients respond to or are eligible for ESA. Even among responders, responses typically last between 18 to 24 months. There also remains very high unmet need in frontline patients who are ESA ineligible given their high baseline serum EPO levels. Treatment options are limited for patients who have failed or are ineligible for ESA and may include HMAs and Luspadicept, which is approved for ring side aeroglass positive patients. RS negative patients represent approximately 75% of all lower-risk MDS patients, and treatment options in this setting do not offer evidence of durable and continuous transfusion independence. Therefore, we believe this market in ESA relapsed refractory and ESA ineligible lower-risk MDS patients is under-saturated and ripe for innovation with the new, innovative, and durable treatments that will be able to be broadly used across MDS subtypes. We see a substantial and compelling commercial opportunity for Imatel-STAT as depicted across the key segments in the red boxes on this slide. This next slide highlights the key attributes of Imatel-STAT phase three I-MERGE trial that resonated most strongly with community and academic hematologists. Specifically, with regards to efficacy, physicians perceived a strong totality of clinical benefit and meaningful durability of response. This was attributable to compelling TI rates across RS subtypes, sustained reduction of RBC units, and continuous rise in hemoglobin levels. Further, 16 and 24 week TI data was regarded as more robust than current standards of care. With regards to safety, physicians perceive the AE profile as predictable with manageable cytopenias. Given the familiarity of the adverse event profile with transient cytopenias, physicians expect to use imetelstat in their low-risk MDS patients across both community and academic settings. Our market research also indicates that hematologists perceive imetelstat's benefit-risk profile provides a compelling treatment option across RS subtypes and in high-transfusion burden patients. In additional interviews with over 30 hematologists from U.S. and key European markets, physicians communicated that Imetelstat would be strongly preferred treatment of choice for RS negative ESA relapse refractory low-risk MDS patients, regardless of the level of transfusion burden, with enthusiasm for efficacy improvements observed from clinical studies, as well as dissatisfaction with current treatments. In the ESA relapsed refractory RS positive segment, hematologists considered the reported durability of imetelstat's transfusion independence to be compelling and would provide significant improvement in long-term response over other options. Furthermore, physicians noted that gaining more clinical experience with the drug may increase conviction to prescribe imetelstat ahead of currently available options. Lastly, Clinicians stated that Imitelstat's efficacy profile was significantly differentiated in high-transfusion burden patients, which further bolsters their opinion that Imitelstat may be a compelling option over currently approved therapies. We also conducted market research with 50 practicing hematologists in the U.S. recently. Our goal was to understand how they would use Imitelstat if available as compared to other potential future therapies. We asked them about future treatment paradigm across key patient segments, second-line patients who may receive ESAs in the frontline setting, second-line patients who may receive lispadicept in the frontline setting, and frontline patients who are ESA ineligible due to serum EPO levels being greater than 500. Their responses indicate strong enthusiasm for imital stat to be integrated in the low-risk treatment upon potential approval. Imatelstat is expected to become a new standard of care in second-line lower-risk MDS and an important new treatment option. I look forward to continuing to provide updates on the commercial activity and market insights throughout the year. Now, I'll turn the call over to Olivia for a financial update. Olivia?
spk05: Thanks, Anil, and thanks to everyone on the call for joining us today. please refer to the press release we issued this morning, which is available on our website for detailed financial results. As expected and in line with our financial guidance, there was an increase in operating expenses for the first quarter of 2023 compared to the same period in 2022. The increase in R&D expenses for the first quarter of 2023 compared to the same period in 2022 primarily reflects higher clinical trial costs for increased activity for both Phase III trials and the Phase I trial and frontline MF, increased personnel-related costs for additional headcount, and higher consulting costs to support regulatory submissions. These higher costs were partially offset by lower Immatelstat manufacturing expenses due to the timing of batches. The increase in general and administrative expenses for the first quarter of 2023 compared to the same period in 2022, primarily reflects higher personnel-related expenses for additional headcount and increased costs for new commercial preparatory activities. Turning to our financial resources, as of March 31, 2023, we had approximately $409.2 million in cash and marketable securities. This balance reflects the receipt of $213.3 million in net cash proceeds from an underwritten public offering completed in January 2023, and approximately $59.8 million in proceeds for warrant exercises in the first quarter of 2023. Based on our current operating plans and our expectations regarding the timing of the submission and potential acceptance and approval of our planned NDA by the FDA for imitaliset and low-risk MDFs, and the subsequent potential U.S. commercial launch in the first half of 2024, we believe that our existing financial resources will be sufficient to fund our projected operating requirements through the end of the third quarter of 2025. We continue to expect non-GAAP total operating expenses up to $210 million for the full year of 2023. The fiscal year 2023 financial guidance reflects regulatory submissions in 2023, ongoing clinical trials, eMERGE Phase 3, ImpactMF, ImproveMF, and IMPRESS, as well as preclinical studies in lymphoid malignancies and discovery research for a next-generation telomerase inhibitor, manufacturing commercial inventory of imetelstat, preparations for potential U.S. commercial launch of Imatelsat and low-risk MDS, projected increases in headcount, and interest payments on outstanding debt. The fiscal year 2023 financial guidance is based on a set of assumptions. If those assumptions are updated later in the year due to changes in our plans, including in response to potential revised timing of FDA approval and U.S. commercial launch of Imatelsat and low-risk MDS, then we plan to update guidance at that time. With that, I will now hand the call back to Chip for closing remarks. Chip?
spk12: Thanks, Olivia. Well, I hope everyone can see the remarkable opportunities associated with Immatelstat and its profile for patients and shareholders. To finally bring Immatelstat to this precipice of potential commercialization, after many years of an incredibly dedicated effort from one of the most experienced and committed teams, I've had the pleasure to work with over a long career in this industry, is a source of great honor and deep satisfaction. I appreciate all of our employees' continued dedication and collaboration, as well as the strong support of our shareholders, many of whom have believed in this drug and the company for literally decades. Thank you. So, operator, with that, let's open the call to Q&A.
spk10: At this time, I would like to remind everyone, in order to ask a question, press star, then the number one on your telephone keypad. We'll pause for just a moment to compile the Q&A roster. And your first question comes from a line of Stephen Woolley from Stifel. Your line is open.
spk01: Yeah, good morning. Thanks for taking the questions. Just curious how much incremental follow-up will the ASCO and EHA presentations include relative to the three additional months that are included in the EHA abstract today? And then I guess second to that, does the updated one-year TI data in today's abstract now include a mature numerator in terms of the valuable number of patients out to 12 months, or should we expect that number to kind of trend up a little bit more as TI achieving patients across that 12-month threshold. And then I just have a quick follow-up.
spk12: Okay. Hi, Steve. It's Chip. Thanks. Steve, just a clarification on the first question. You were looking for, I think the way I interpreted it is a question about what will be presented at ASCO and EHA was how much incremental follow-up would be represented by those ultimate presentations, and would they be any different from what are in the abstracts? Was that the question?
spk01: Yeah, correct. So presumably you have an additional three months follow-up relative to the top-line cut per today's EI abstract. I'm just curious if the actual presentations themselves will have a later cut-off date with more follow-up.
spk12: Yeah. Faye will answer both of these in a second. And the second question was just the updated one-year TI. TI, just whether or not you have a mature new trainer. Is that relatively mature? Yeah. Faye? Faye?
spk03: Sure. Thanks for the question, Steve. Excuse me. The three-month follow-up that we cite in the abstract will be consistent with what we present during the presentation at EHAS. We don't anticipate any additional follow-up. And that's because at this time, or at that time, the one-year TI data is mature, and we don't anticipate any additional one-year TI patients. Additionally, just to say that the earlier 8- and 24-week TI responders are mature as well.
spk01: Okay. And then just on the VAF reductions that you guys are describing in the abstract data today, Do you see a differential effect at all as a function of baseline risk status, whether a patient is low or intermediate? And I guess I'm just trying to think about how this data could potentially impact the much higher risk of leukemic transformation that is typically associated with an intermediate risk patient.
spk03: Thanks for the question. We will present additional characteristics about baseline. with relation to mutation reduction during the presentation.
spk01: Okay. And if I could squeeze in just one quick more for Anil, actually. Sure. Just on the market research slide, you know, I guess I'm curious about your thoughts regarding it looks to be about one-third of prescribers that are suggesting frontline use of lispatacept in ESA ineligible patients. And then another 30% of prescribers suggesting they'd either resequence lispatacept or use an ESA and second-line lispatacept-experienced patients. Just curious about how you're thinking about that data, just given that there's, to my knowledge, no clinical data to support any of this utilization.
spk09: We could not agree more, Steve. I think this is all about future anticipated evolution within the market. I think what's very clear to us, to your point, is that there is very high unmet need, and it is showing clear dissatisfaction with current therapies. In the ESA ineligible patients, obviously the COMMANDS trial did not recruit patients with a baseline EPO level greater than 500. The data from iMERGE is very supportive, and we would expect IMITEL to start to be well positioned within that marketplace. And I think the entire frontline space is going to be likely a mix of ESAs, potentially some Luspatacept use. And in terms of sequencing after the first line, I think that's also dependent pretty heavily on how Imatel stat would position itself within the market upon being available. I think right now these are still fluid, and we would expect over the next year, year and a half to fully understand the evolved low-risk MDS market space.
spk16: All right. Thanks for taking the question, guys. Thanks, Steve.
spk10: And your next question comes from the line of Kalpit Patel from B. Reilly. Your line is open.
spk13: Yeah. Hey, good morning. Thanks for taking the question. Maybe one more on that market survey. The data in the second column, were these results under the assumption that Reblazil secures frontline utilization in both RS-positive and RS-negative patients, or was this just assuming usage for Reblazil in frontline is only in RS-positive patients?
spk09: We assumed the broadest possible label for Luspatacept, again, based on publicly available information. And that is how we are even seeing the space for ourselves at this point of time. Obviously, we do not know the full commands data, the subgroups, and their regulatory interactions. But our expectation is, and this research specifically culprit to your question, was based on full approval of Revlozel across both the indications as a stimuli to the physicians.
spk13: Okay, and was this survey conducted before the commands abstract data were out last month, or was it after that data?
spk09: We conducted this survey very, very recently. We conducted this survey with all publicly available information, and we obviously are aware of the data sets from EHA. that are available in the public domain. So I'll just leave it at that, Calvin. Okay, okay.
spk13: And then I had one last question on the cytopenias for imitalistac. Do we have a sense of what proportion of low-risk MDS patients have underlying severe cytopenias, you know, before they start therapy? And did you exclude those types of patients in the eMERGE study?
spk03: Thanks for the question, Cal. It's a fail answer. With respect to lower-risk MDS patients, by the nature of the fact that they're lower-risk, it means that they don't have severe cytopenias in general. I can't provide you with an exact number, but I know that it's very few. We did have neutrophil and platelet requirements for entry into the study.
spk09: And, Kalpa, just to add on all the real-world literature that we have, essentially corroborates what Faye pointed out in terms of the baseline characteristics of these patients do not typically indicate severe cytopenic risk.
spk13: Okay. That's very helpful. Thank you very much.
spk16: Thanks, Cal.
spk10: And your next question comes from a line of Joel Beattie from Baird. Your line is open.
spk15: Thanks for the update and for taking the questions. This one is on the cash guidance through the end of Q3 2025. Does this include revenue from Immatelsa sales in MDS, and also does it include potential cash received from the exercise of additional warrants?
spk02: Hi, Joel. It's Olivia. So, the guidance includes sales from or revenues from product sales for Immatelsa and low-risk MDS. It does not include of future cash proceeds that could be from more exercises.
spk15: Great. Thank you. A question on could you just discuss launch preparation and kind of the timing that you see the next steps of getting ready for that launch and where you're currently at?
spk09: So Joel, I'll take the question first and others can add on as well. So our anticipation is with regulatory filing in June of 2024 as we stated. We would expect to launch Imitel start in first half of 2024, depending upon the PDUFA that gets assigned to our application. We obviously are preparing for a successful launch with all the various aspects that are indicated across the buckets. And the most important things for us to highlight continue to be a integrated, comprehensive, clinical and economic summary, which is really important and very extensive interactions with all set of stakeholders as we bring this drug to the market. And from an organizational perspective, we are preparing ourselves and all our enterprise entity functions to be able to successfully commercialize Imitelstat. And really grateful for the team that's been assembled with very, very high talent and high operational experience. So continue to provide updates, you know, over the next six months and the year as we go through on our launch prep activities. Is there any question that I didn't answer, Joe, that we can take away?
spk15: That's helpful. Thank you.
spk11: And your next question comes from a line of Gil Blum from Needham and Company.
spk10: Your line is open.
spk14: Hey, good morning, everyone, and thanks for taking our questions. So first one for Anil. Just to put the cash position in perspective, do you think it enables sales expansion on increased demand if needed?
spk09: So our – and I'll ask Olivier to comment as well. We obviously have our internal projections on the forecast. and we believe that we are in a very strong position as we speak through 2025 and with two years for uptake in this market. This data gel is pretty unprecedented in low-risk MDS. The unmet need remains very high. It has been validated again and again by physicians, so we expect faster adoption within this marketplace, which should obviously any opinions from your side.
spk04: Bill, I'm just curious. Are you asking the question to ensure that we have enough inventory on hand in case the demand spikes and that we have the cash to be able to manufacture that inventory? Is that the basis of the question?
spk14: The question is more of whether you have flexibility to increase your sales exposure, i.e. more reps or centers if there is demand.
spk09: Yeah. So we, uh, so Joel, even on that, uh, sorry, uh, Jill on that, um, question as well, we are planning for a national coverage at launch, uh, in the U S, um, uh, across all of our key centers, we expect to be share of voice competitive from day one. And we are also planning obviously for our second indication. in myelofibrosis, which is expected to produce results in either 24 or 25, depending upon, you know, the data as it matures for events. And our expectation is we'll be fully scaled for the first indication, and we will be appropriately present for the second indication as well. And those are all part of our long-term planning assumption. So hopefully that answers that aspect of the question as well.
spk14: Okay. And, Anil, if I still have you, so I know you touched on this, but how does, in your survey, how does Luspatacept after Luspatacept make sense?
spk09: I think I did my best to answer that question before. I take all these surveys as directional surveys. I think what is very clear is it's likely to be an unnatural choice. I think as we all know, when new effective treatments which are highly differentiated with newer mechanisms become available, I think physicians start to do what's best for their patients and tailor regimens appropriately. We would expect a similar dynamic. When I look at that research, I come back heavily encouraged. as to the clear preference for imital start across the second line settings, irrespective of what happens in the frontline. And a very clear indication that the frontline ESA ineligible patients remain high, high unmet need and a preference for new agents in that setting as well. And our data set Our value proposition that we would communicate would highlight each and every one of these activities, and we would expect it to be extremely well adopted at a fast pace within the marketplace. So we are encouraged, but there is a lot more to come, and I think this space will evolve and expand.
spk12: Hey, Gil, it's Chip. So I'll add the obvious since I'm a physician. There's no accounting for taste sometimes, especially early in a early in the evolution of a market undergoing change. But I would really echo what Anil said. And this actually, I would make comments from some of the other questioners on the call. I think we see this very much as the glass very more than half full here. We're focused, of course, on our own drug, and we were very encouraged by these findings. The nuances of how all of these different preferences get expressed today, I think, and Neil put it beautifully, it'll evolve as both more data, as guidelines, as other elements in the commercial space really evolve. It'll all evolve. But we were very encouraged by these perceptions of value that really were exhibited by the surveyed physicians.
spk03: Okay. I'll add just one more quick comment that I think these, you know, maybe unexpected treatment patterns that result from the survey, really what they're speaking to is the unmet need in this patient population and the lack of therapeutic options so that, you know, providers are just like, I'll give them what I have. Even if I tried it before, I'll try it again. Yep.
spk16: It happens.
spk14: okay and thanks for the question maybe maybe our last one on on cytogenetics here i feel first of all a lot of this data is very consistent with what you saw in the face to emerge i remember you put a pretty significant data analysis on that and i have a question that i had back then still have which is is there is there any diagnostic potential here for for patients um you know for mds patients even even early on when they're just diagnosed. Not that you need to do this because your study is already working in the general population, but if you could predict who has a higher chance of being a responder.
spk03: Thanks for the question. I think one of the, you know, distinguishing characteristics of Imatelstat is that, obviously, as a telomerase inhibitor, it, you know, can benefit a broad range of subtypes, cytogenetic types, mutation types. So I don't anticipate that we will ever see a selectivity toward any cytogenetic signal or a mutational signal. And I think that's one of our – that's a characteristic of the, you know, inherent nature of telomerase inhibition and the target that Imatel-STAT focuses on.
spk16: Okay. That's fair. All right. Thank you. Thanks, Gil.
spk10: And your next question comes from a line of Corrine Jenkins from Goldman Sachs. Your line is open.
spk00: Hey, good morning, everyone. A couple questions from us. It looks like the address will market you lead out, which is about $3.5 billion in low-risk MDS, assumes a price point of about $25,000 per month. Is that roughly the price you're planning to launch with? And I'm curious what underpins that particular expectation and if you've had any conversations with PEARS to date on how they think about that.
spk09: So, Corinne, I'll take that question. So, first, we have extensive interaction with PEARS both in the U.S. and Europe over the last few years and continue to strengthen those interactions. In low-risk MDS, the best analog for us to consider are the currently approved drugs. I'll specifically point out to Luspatacept. And for low-risk MDS, I think it's publicly known that the average dose is now pretty much at the highest end of their approved label. And when we look at price points, obviously that is one anchor. But importantly for us, We continue to focus on our value proposition, both clinical, economic, and even through the PRO data, which is highly, highly differentiating. And we would expect favorable pricing for our drug at launch. And within oncology, these price points, as you mentioned, are pretty much the norm. And our expectation is favorable pricing, you know, as we bring out our data and our evidence within the space.
spk00: Thanks. And then maybe another one from us, just how are you thinking as you approach the U.S. launch about ex-U.S. commercialization plans and when should we expect to get more color on filing timelines and whether you plan to go it alone or through a partnership?
spk09: So our guidance for European filing still remains the same, which is in the second half of this year. We are taking appropriate steps to engage with pairs, which is pretty mandatory, especially in the key markets today. Our expectation is to make a final decision around European commercialization strategy in the second half of the year. And obviously, we'll provide guidance at that point in time.
spk11: Thanks.
spk10: And that is all the time we have for questions. I will now turn the call back over to Ms. Erin Feingold for some final closing remarks.
spk06: Thanks, everyone, so much for joining us today during this very, very exciting time for Geron. We look forward to continuing to keep you up to date. Have a great day.
spk10: This concludes today's conference call. Thank you for your participation. You may now disconnect.
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