Q1 2025 Geron Corp Earnings Call

Unknown Executive: recently approved for the treatment of certain patients with lower risk MDS, a disease with significant unmet needs. We believe that there is a large U.S.

With lower risk Mds.

Disease with significant unmet need.

We believe that there was a large U S market opportunity for <unk> in Q1 sales were not where we expect them to be.

Unknown Executive: market opportunity for Ritello and Q1 sales were not where we expect them to be. Q1 Ritello net revenues were $39.4 million, down $8 million from Q4, while demand in the 13-week period through the week ending March 28th was relatively flat at plus 1% versus the prior 13-week period. The lower quarter over quarter net revenue is due to the inventory drawdown among our distributors from Q4 into Q1.

Q1, <unk> net revenues were $39 4 million down 8 million from Q4, while demand in the 13 week period through the week ending March 28th was relatively flat at plus 1% versus the prior 13 weeks the law.

Lower quarter over quarter net revenue is due to the inventory draw down among our distributors from Q4 into Q1.

Michelle Robertson: Michelle will address this in greater detail in our financial update.

Michel will address this in greater detail in our financial update.

Speaker Change: Personally I stepped into this role because I'm excited by the opportunity to bring this important medicine to eligible patients in the health care community and together with this leadership team execute on this commercial opportunity and drive value for all involved.

Unknown Executive: Personally, I stepped into this role because I'm excited by the opportunity to bring this important medicine to eligible patients and the healthcare community, and together with this leadership team, execute on this commercial opportunity and drive value for all involved. Today we'll share key factors that we believe have influenced the recent soft performance, as well as specific enhancements we've made and continue to make to support U.S. commercial success. We expect our increased commercial investments to bolster uptake across a broader group of prescribers and drive long-term demand.

Speaker Change: Today, we will share key factors that we believe have influenced the recent soft performance as well as specific enhancements, we've made and continue to make to support U S commercial success.

Speaker Change: We expect our increased commercial investments to bolster uptake across a broader group of prescribers and drive long term demand.

Unknown Executive: Since our last earnings call, we've performed an in-depth analysis of our commercial efforts with the current market, and we're focused on three key strategies to invigorate sales growth. First, we are investing additional resources to increase brand awareness among the highest decile U.S. hematologists treating the greatest number of lower-risk MDS patients today. Second, we're refining our marketing and medical efforts to enhance prescribing clarity and competence with the use of Rytelo, articulating how and where to use it successfully as indicated in our approved label with the goal of supporting positive HCP and patient experiences and continued And third, we're implementing programs to expand U.S.

Speaker Change: Since our last earnings call, we performed an in depth analysis of our commercial efforts with the current market and were focused on three key strategies to invigorate sales growth.

Speaker Change: First we are investing additional resources to increase brand awareness among the highest decile U S. Hematologist treating the greatest number of lower risk Mds patients today.

Speaker Change: Second we're refining our marketing and medical efforts to enhance prescribing clarity and confidence with the use of right Hello, articulating, how and where to use it successfully as indicated in our approved label with the goal of supporting positive HCP and patient experiences and continued use.

Speaker Change: And third we're implementing programs to expand U S kols support and advocacy through our lines messaging education and through both commercial and medical affairs engagement efforts.

Unknown Executive: KOL support and advocacy through aligned messaging, education, and through both commercial and medical affairs engagement efforts.

Unknown Executive: Today, Jim and Jill will share further details of specific commercial and medical affairs actions to implement these three key strategies. This includes refined HCP target identification, expanded sales and medical field headcount, and the addition of newly created goals to highlight only a few. We're confident that by intensifying our focus on the strong execution of launch fundamentals, that we'll see performance trends moving in the right direction. and are encouraged by a few recent early performance indicators that we will share with you today.

Speaker Change: Today, Jim and Joe will share further details of specific commercial and medical affairs actions to implement these three key strategies.

Speaker Change: This includes refined HCP target identification expanded sales and medical field head count and the addition of newly created roles to highlight only a few.

Speaker Change: We're confident that by intensifying our focus on the strong execution of launch fundamentals that will see performance trends moving in the right direction and are encouraged by a few recent early performance indicators that we will share with you today.

Speaker Change: Success takes them organized team effort and we've invested with deliberate attention and urgency to reinvigorate this launch.

Unknown Executive: Success takes an organized team effort, and we've invested with deliberate attention and urgency to reinvigorate this loss.

Speaker Change: With our recent EU approval in March we are pursuing what we believe is a targeted disciplined path to make quite hello available to patients beyond the United States, while being fiscally responsible.

Unknown Executive: With our recent EU approval in March, we are pursuing what we believe is a targeted, disciplined path to make Ritello available to patients beyond the United States while being fiscally responsible. Our strategy is to work with experienced third parties to help minimize the investment needed outside of the United States, allowing our teams to focus on our top priority of driving our U.S. commercial efforts.

Speaker Change: Our strategy is to work with experienced third party to help minimize the investment needed outside of the United States, allowing our teams to focus on our top priority of driving our U S. Commercial efforts, we do not plan to commercialize in Europe or any other region outside of the United States independently.

Unknown Executive: We do not plan to commercialize in Europe or any other region outside of the United States independently.

Unknown Executive: We're also excited about our late stage clinical development program that could expand in Mattelstat for use more broadly within hematology and continue to fill unmet needs. Impact MF is our Phase 3 Pivotal Trial evaluating imetelstat in relapsed refractory myelofibrosis with an endpoint of overall survival.

Speaker Change: We're also excited about our late stage clinical development program that could expand in Mattel stat for use more broadly within the hematology and continue to fill unmet needs.

Speaker Change: Impact MF is our phase III pivotal trial evaluating <unk> in relapsed refractory myelofibrosis with an endpoint of overall survival.

Unknown Executive: If we're successful in this trial and Inmatelstat is approved in this setting, we believe that the opportunity exists to meaningfully expand and potentially double the commercial potential of Ritello.

Speaker Change: If we're successful in this trial and <unk> is approved in this setting we believe that the opportunity exists to meaningfully expand and potentially double the commercial potential of rights Hello.

Unknown Executive: Joe will provide an update on enrollment and potential near-term milestones, including the interim analysis that is anticipated in the second half of next week.

Speaker Change: Joe will provide an update on enrollment and potential near term milestones, including the interim analysis that is anticipated in the second half of next year.

Unknown Executive: Before turning the call over to Jim, I will also mention that our process to identify a permanent chief executive officer is ongoing. Our board is working with an experienced executive search firm to identify and evaluate candidates with strong commercial leadership in our industry.

Speaker Change: Before turning the call over to Jim I will also mention that our process to identify a permanent chief Executive officer is ongoing.

Speaker Change: Our board is working with an experienced executive search firm to identify and evaluate candidates with strong commercial leadership in our industry. We expect a decision to be made and announced within the next six months with that I'll hand, the call over to Jim to provide a U S commercial update.

Jim: We expect a decision to be made and announced within the next six With that, I'll hand the call over to Jim to provide a U.S. commercial. Thanks, Don, and good morning, everyone. Today, I will provide a commercial performance update and highlight key actions we have taken and are continuing to take to drive enhanced launch performance, as well as recent encouraging performance indicators that we are tracking. We believe Ritello is a highly effective novel treatment that fills a significant need in an underserved therapeutic area. We also believe that Ritello has a strong and differentiated product label, positive NCCN guidelines, and broad U.S.

Jim: Thanks, Don and good morning, everyone.

Jim: Today, I will provide a commercial performance update and highlight key actions, we have taken and are continuing to take to drive enhanced launch performance as well as recent encouraging performance indicators that we are attracting.

Jim: We believe right Tullow is a highly effective novel treatments that builds a significant need and then underserved therapeutic area.

Jim: We also believe that <unk> has a strong and differentiated product label Pago.

Jim: Positive BCN guideline and broad U S payer coverage.

Unknown Executive: payer coverage.

Jim: This is why we believe that we can reignite this launch with the plans that we are executing and maximized by TELUS potential in a market with considerable opportunity. On slide seven, we outline the estimated U.S. total addressable market for Ritello at approximately 15,400 lower risk MDS patients based upon the label and NCCN guidance. To date, most usage has been in the third line class setting. Youth in Later Lines often occurs until HCPs gain experience with a new therapeutic agent. There is significant opportunity for Ritella to expand use in earlier lines of treatment, including first line ESA ineligible and second line ESA relapsed refractory patient.

Jim: This is why we believe that we can reignite. This launch with the plans that we are executing and maximize <unk> potential in a market with considerable opportunity.

Jim: On slide seven we outline the estimated U S total addressable market for rice Palo at approximately 15400 lower risk Mds patients based upon the label and N CCN Garden bar.

Jim: Good day, most usage has been in the third line setting.

Jim: Use in later lines often occurs until hcp's gain experience with a new therapeutic agent.

Jim: There is significant opportunity for <unk> to expand use in <unk>.

Jim: Earlier lines of treatment, including first line Esa ineligible and second line Esa relapsed refractory patients.

Unknown Executive: In Europe, we estimate that the EU4 total addressable market for Ritello is approximately 80% of the US.

Jim: In Europe, we estimate that the EU for total addressable market for <unk> is approximately 80% of the U S.

Jim: Later in this call Joe will provide an update on our ongoing phase III relapse refractory myelofibrosis clinical trial impact.

Unknown Executive: Later in this call, Jill will provide an update on our ongoing phase three relapsed refractory myelofibrosis clinical trial, IMPACT-MS, with a planned interim analysis expected in the second half of 2020. Early pre-commercial planning, including market and landscape assessment, is now underway. Our preliminary estimate for the U.S. total addressable market is approximately 10,000 JAK inhibitor relapse refractory myelofibrosis patients. And the EU4 total addressable market is approximately 9000 JAK inhibitor relapse refractory myelofibrosis.

Jim: With a planned interim analysis expected in the second half of 2026.

Jim: Early pre commercial planning, including market and landscape assessment is now underway.

Jim: Our preliminary estimate for the U S. Total addressable market is approximately 10000 JAK inhibitor relapse refractory myelofibrosis patients.

Jim: For total addressable market is approximately 9000, JAK inhibitor relapsed refractory myelofibrosis patients.

Unknown Executive: We will provide commercial planning updates as we approach key impact MS clinical and regulatory milestones.

Jim: We will provide the commercial planning updates as we approach key impact from a clinical and regulatory milestones.

Jim: Our top corporate priority is the successful commercialization of <unk> in the U S.

Jim: Our top corporate priority is the successful commercialization of Ritello in the U.S. On slide 8, I will highlight our strategies, plan of action, and thoughtful investments to support this priority. First, we are working to improve Ritello brand awareness, and we have invested in our team to better reach, inform, and educate healthcare providers, especially community-based patients. Our strategy is to increase our brand awareness through greater presence and share of voice within our HCP targets.

Jim: On slide eight I will highlight our strategy plan of action and thoughtful investments to support this priority.

Jim: First we are working to improve right Hello brand awareness and we have invested in our team to better reach inform and educate health care providers, especially community base HCP.

Jim: Our strategy is to increase our brand awareness through greater presence and share of voice within our HCP targets.

Jim: We treat the majority of lower risk MDS. We believe that the sales team is the most effective and efficient way to reach our target HCP audience with an aligned message and one of the most powerful communication forces we can employ to make an impact quickly. We are increasing our customer-facing teams by more than 20%, which is designed to improve our reach and message delivery, especially for higher-decile HTPs who treat the greatest number of Ritello-eligible, lower-risk MDS patients. This expansion includes adding not only additional key account managers, but also oncology clinical educators and a newly created field-based regional market.

Jim: Treat the majority of lower risk Mds patients.

Jim: We believe that the sales team is the most effective and efficient way to reach our target HCP audience within aligned message and one of the most powerful communication forces, we can employ to make an impact quickly.

Jim: We are increasing our customer facing teams by more than 20%, which is designed to improve our reach and message delivery.

Jim: Firstly for higher decile HCP to treat the greatest number of REIT eligible lower risk Mds patients.

Jim: This expansion includes adding not only additional key account managers, but also oncology clinical educators in a newly created field based regional marketing team.

Jim: Recruiting and hiring is underway. We plan to have the new hires on board and in the field beginning in early Q3 and expect to see their impact later this year. In addition to the field team expansion, we are also pursuing community-based educational and outreach initiatives, such as speaker programs, webinars, and digital campaigns designed to drive broad reach and awareness, especially for lower-decile community HCPs to treat fewer lower-risk MDS patients and may not see a key account manager as often.

Jim: Recruiting and hiring is underway.

Jim: We plan to have the new hires onboard and in the field beginning in early Q3 and expect to see their impact later this year.

Jim: In addition to the field team expansion. We are also pursuing community based education and outreach initiatives, such as speaker programs Webinars and digital campaigns designed to drive broad reach and awareness.

Jim: Before lower decile community HCP.

Jim: You were lower risk Mds patients and may not be a key account manager as often.

Jim: Second, we are working to increase HCP prescribing competence through clinical experience and patient success stories. We believe there is an opportunity to reinforce Rytel's strong therapeutic profile and product differentiation, especially focusing on the second-line post-ESA or ESA-ineligible patients to drive earlier use aligned with our approved label. Our strategy is to increase HCP prescribing competence and clarity through education and strong messages that reinforce Ritellus product differentiation through the expanded field team, especially targeting our higher volume, lower risk MDS treats. We are also enhancing our omnichannel initiatives, including social and digital campaigns in an effort to expand the reach of our key marketing messages, especially for our lower volume, community based, lower risk MDS treaters, and complement the messaging efforts of our sales.

Jim: Second we are working to increase HCP prescribing confidence.

Jim: Clinical experience and patient success stories.

Jim: We believe there is an opportunity to reinforce vitale with strong therapeutic profile and product differentiation, especially focusing on the second line post Esa or Esa ineligible patients to drive earlier use align with our approved label.

Jim: Our strategy is to increase HCP prescribing confidence and clarity through education and strong messages that reinforce <unk> product differentiation through the expanded field team, especially targeting our higher volume lower risk Mds treaters.

We are also enhancing our omnichannel initiatives, including social and digital campaign in an effort to expand the reach of our key marketing messages, especially for a lower volume community base lower risk Mds treaters and complement the messaging efforts of our sales team.

Jim: Our commercial and medical affairs teams are also addressing and educating HCPs on appropriate cytopenia management to increase HCP prescribing competence.

Jim: Our commercial and medical affairs teams are also addressing and educating.

Jim: <unk> is an appropriate cytopenia management to increase HCP prescribing confidence and Joe will highlight key considerations on Cytopenia management and expectations later during his section.

Jim: And Joe will highlight key considerations on cytopenia management and expectations later during his session. Third, we are working to generate stronger KOL support and advocacy across the U.S. We believe that increased KOL advocacy is essential to building broader support and use of Ritello given the limited number of U.S. clinical trial investigators and patients who participated in IMER. Our strategy is to strengthen U.S. AOL advocacy through education and engagement supporting our launch success, and we have made investments to do so. To support the commercial team's engagement with KOL, we have further expanded our commercial team headcount, creating a new field-based regional market.

Jim: Third we are working to generate stronger kols support and advocacy across the U S.

Jim: We believe that increased kols advocacy is essential to building broader support and use of Brighthouse given the limited number of U S clinical trial investigators and patients who participated in armor.

Jim: Our strategy is to strengthen U S kols advocacy through education and engagement supporting our launch success and we have made investments to do so.

Jim: To support the commercial team's engagement with Kols, we have further expanded our commercial team head count, creating a new field based regional marketing team.

Jim: Their responsibilities are to cultivate and develop stronger pale well relationship and support of advancing patient care and lower risk MDS. The regional marketing team identifies opportunity and data needs to further support product differentiation with KOL input and validation. Based on these opportunities and needs, the clinical and medical affairs team independently prioritizes data generation opportunities to enhance Rytel's clinical share of voice with increased publications and presentations at Congress. The regional marketing team will work with top KOLs in peer-to-peer educational initiatives like speaker programs, executive engagement, and community-focused educational initiatives. We are excited about the potential of this newly created team to strengthen our relationship with the top KOLs.

Jim: Their responsibilities are to cultivate and develop stronger relationships in support of advancing patient care and lower risk Mds.

Jim: The regional marketing team identifies opportunity and data needs to further support product differentiation with kols and put and validation.

Jim: Based on these opportunities and need the clinical and medical affairs team independently prioritizes data generation opportunities to enhance <unk> clinical share of voice with increased publications and presentations at Congresses.

Jim: The regional marketing team will work with top Kols and peer to peer educational initiatives like speaker programs executive engagement and community focused educational initiatives.

Jim: We are excited about the potential of this newly created team.

Jim: Strengthen our relationship with the top Kols.

Jim: Turning to slide nine we have refined and continue to refine our accounts in Asia.

Jim: Turning to slide nine, we have refined and continue to refine our account and HCP targeting, which we believe will allow us to reach physicians treating the majority of lower risk MDS patients. We estimate that approximately 6,308 HP currently treat approximately 80% of lower risk MDS patients in the United States. We further estimate that approximately 1,300 HCPs treat approximately 50% of the currently diagnosed lower risk MDS. These data provide good insights into where Ricello-eligible patients are being treated, and these ACPs are our commercial focus for personal and non-personal promotional efforts. Our refined targeting effort is designed to help us effectively reach, engage, and educate HCPs treating the majority of currently diagnosed ritello-eligible lower-risk MDS patients.

Jim: <unk> targeting which we believe will allow us to reach physicians treating the majority of lower risk Mds patients.

Jim: We estimate that approximately 6300 HCP currently treat approximately 80% of lower risk Mds patients in the United States.

Jim: We further estimate that approximately 1300 HCP treat approximately 50% of the currently diagnosed lower risk Mds patients.

Jim: These data provide good insight into where Reits Hello eligible patients are being treated and these HCP, our commercial focus for our personal and non personal promotional efforts.

Jim: Our refined targeting effort is designed to help us effectively reach engage and educate hcp's treating the majority are currently diagnosed right, although eligible lower risk Mds patients.

Jim: Turning to slide 10, we believe these recently implemented an ongoing commercial actions will drive increased product demand over time, while early we are pleased to see modest improvement in several leading commercial performance indicators.

Jim: Turning to slide 10, we believe these recently implemented and ongoing commercial actions will drive increased product demand over time. While early, we are pleased to see modest improvements in several leading commercial performance indicators. As of April 2025, approximately 900 sites of care have utilized Ripello. This is an increase of almost 300 new sites since the end of Q4. Of the accounts that previously ordered, approximately two-thirds have reordered in Q1. Demand grew approximately 10% in the current four-week period ending April 25 compared to the prior four-week period. This represents the highest month-over-month growth since October 2024.

Jim: As of April 2025, approximately 900 sites of care have utilized <unk>. Hello. This is an increase of almost 300 new sites since the end of Q4 of <unk>.

Jim: The accounts that previously ordered approximately two thirds every ordered in Q1.

Jim: Demand grew approximately 10% and the current four week period, ending April 25, compared to the prior four week period.

Jim: This represents the highest month over month growth since October 2024.

Jim: The rolling three month market claims data as of February 2025 estimates that approximately 25% of <unk> new patient starts were in the first and second line.

Jim: The rolling three-month market claims data as of February 2025 estimates that approximately 25% of Ritello new patient starts were in the first and second line. We expect to see an increase in second line use as HCPs gain more experience with Ritello and become more comfortable prescribing it in earlier settings. Our recent market research evaluating intention to treat suggests physicians intend to use Ritalo and earlier lines of therapy. Payor access continues to strengthen, with approximately 85% of U.S. covered lives now under favorable Rite-Halo medical coverage policies that are consistent with the FDA label and or NCCN guidance.

Jim: We expect to see an increase in second line use as Acp's gained more experience with bright yellow and become more comfortable prescribing it in earlier settings.

Jim: Our recent market research evaluating intention to treat suggests physicians tend to use right tallow and earlier lines of therapy.

Jim: Payer access continues to strengthen with approximately 85% of U S covered lives now under favorable rights Hello medical coverage policies that are consistent with the FDA label and <unk> guidelines.

Jim: I want to acknowledge the cross-functional team, and especially the sales team, who are executing the plan to deliver on these leading performance indicators and demonstrating strong patient's interest.

Jim: I want to acknowledge the cross functional team and especially the sales team who are executing the plan to deliver on these leading performance indicators and demonstrating strong patient centricity.

Jim: Turning to the EU, we outlined key considerations that our launch planning on slide 11.

Unknown Executive: Turning to the EU, we outlined key considerations in our launch planning on slide 11. We have assembled a small, experienced team to focus on EU4 launch preparation.

Jim: We have assembled a small experienced team to focus on EU for launch preparation.

Unknown Executive: We anticipate commercialization in select EU4 countries starting in 2026, pending favorable reimbursement and completion of critical launch activities. Commercial success in FQS markets is dependent on strong reimbursement and favorable price We are engaging established third party partners across commercial, market access, medical affairs, ATOR, and distribution to prepare for successful commercialization. We also expect to maintain financial discipline in investing for the EU4 launch, with further expansion pending strong reimbursement.

Jim: We anticipate commercialization and select EU four countries, starting in 2026 pending favorable reimbursement and completion of critical launch activities.

Jim: Commercial success in ex U S market is dependent on strong reimbursement and favorable pricing.

Jim: We are engaging established third party partners across commercial market access medical affairs, AQR and distribution to prepare for successful commercialization.

Jim: We also expect to maintain financial discipline and investing for the EU for launch with further expansion pending strong reimbursement.

Jim: We will provide future EU launch planning update as we progress towards commercialization.

Unknown Executive: We will provide future EU launch planning updates as we progress towards commercialization.

Jim: In summary, we have implemented and continue to implement actions specifically designed to enhance <unk> sales performance. We remain confident in the long term potential of brighthouse as a differentiated therapeutic for eligible patients with lower risk Mds.

Unknown Executive: In summary, we have implemented and continue to implement actions specifically designed to enhance U.S. sales performance.

Unknown Executive: We remain confident in the long-term potential of Ritello as a differentiated therapeutic for eligible patients with lower risk MDS. We are aligned on the opportunity and responsibility in front of us, and we are all in on driving success of Rice-Halo.

Jim: We are aligned on the opportunity and responsibility in front of us and we are all in on driving success of REIT tallow.

Joe: I will now turn the call over to Joe Eade, who will provide a medical affairs and clinical development update. Thank you, Jim. I'd like to start by sharing several recent accomplishments from the Medical Affairs Organization. Since our last earnings call, we've implemented steps to further support community awareness of white callow, develop HCP confidence in how and where to prescribe and generate KOL advocacy within the lower risk MDS HCP community. I'm happy to share that we are executing in our We are growing our medical science liaison footprint to reach more accounts by aligning their territorial coverage with the anticipated expansion of our commercial field.

Joe: I will now turn the call over to Joe <unk>, who will provide a medical affairs and clinical development update.

Joe: Thank you Jim.

Speaker Change: I'd like to start by sharing several recent accomplishments from the medical Affairs organization.

Speaker Change: Since our last earnings call, we've implemented steps to further support community awareness of tallow.

Speaker Change: Develop HCP confidence in how and where to prescribe and generated kols advocacy within the lower risk Mds HCP community.

Speaker Change: I'm happy to share that we are executing on our plan.

Speaker Change: Growing our medical science liaison footprint to reach more accounts by aligning their territorial coverage with the anticipated expansion of our commercial field team.

Joe: This effort should help us achieve more streamlined and coordinated account Our field team interacts with HCPs frequently and is aligned with our corporate strategy to reach and educate the lower-risk MDS prescriber community and key opinion leaders. We've expanded the team with payer-focused MSLs and both served leadership in both publication planning and HE awards. In fact, we are in the process of doubling the size of our overall medical affairs team since our last earnings. We have been focused on increasing executive engagement with key institutions and thought leaders to share our data, discuss research areas of interest, and collect insights to inform our strategy.

Speaker Change: This effort should help us achieve more streamline and coordinated account management.

Speaker Change: Our field team interacts with Hcp's frequently.

Speaker Change: Is aligned with our corporate strategy to reach and educate the lower risk Mds prescriber community and key opinion leaders, we've expanded the team with sales focused nsls and bolstered leadership in both publication planning and <unk>. In fact, we are in the process of doubling the size of our overall medical affairs team since I.

Speaker Change: Our last earnings call.

Speaker Change: We have been focused on increasing executive engagement with key institutions and thought leaders to share all the data <unk>.

Speaker Change: Discuss research areas of interest and collect insights to inform our strategy we.

Joe: We are pleased with the positive feedback we have been hearing in these Key opinion leaders are interested in Rytel's unique mechanism of action and learning more about our data that suggests the potential for disease modification. As Jim noted, we are also focused on increasing HCP awareness of white gallop, particularly in the community setting and in centers that did not participate in our phase three pivotal trial, which enrolled the vast majority of patients outside of the United States. We are increasing our efforts to educate and inform the U.S. prescriber community and key thought leaders. We are also pleased with the positive feedback received from many physicians who have shared their positive experience with Ritalin's efficacy, especially in those hard-to-treat, lower-risk MDS patients who are not served well with other approved therapies.

Speaker Change: We are pleased with the positive feedback we have been hearing in these meetings.

Speaker Change: Key opinion leaders are interested in <unk> unique mechanism of action and learning more about our data that suggests the potential for disease modification.

Jim: As Jim noted.

Speaker Change: I'll also focus on increasing HCP awareness of <unk>, particularly.

Speaker Change: Particularly in the community setting and incentives that did not participate in our phase III pivotal trial, which enrolled the vast majority of patients outside of the United States.

Speaker Change: We are increasing our efforts to educate and inform the U S prescribing community and key thought leaders.

Speaker Change: We're also pleased with the positive feedback received from many physicians who have shared their positive experience with tellers efficacy, especially in those hard to treat lower risk Mds patients.

Speaker Change: Not served well with other approved therapies.

Joe: We are also pleased to hear their feedback regarding their experience with Rytelo's safety profile, which has generally been that Rytelo has a manageable safety profile, including the management of cytopenia, which are considered on target or unsurprising, given the drug's unique mechanism of action. In addition, we have received positive feedback of patients' experiences regarding fatigue where other approved therapies can fall short. Our clinical experience with the Metal Spat aligns with what we observed in the preclinical data. An exploratory analysis of the Phase III iMERGE data showed that the exposure to a methostat correlated both qualitatively and quantitatively with reduction in mutation .

Speaker Change: We are also pleased to hear their feedback regarding their experience with the <unk> safety profile, which has generally been that tullow has a manageable safety profile, including the management of Cytopenia, which are considered on target or.

Speaker Change: Unsurprising, given the drugs unique mechanism of action.

Speaker Change: In addition, we have received positive feedback of patient experiences, we've done and fatigue.

Speaker Change: Other approved therapies can fall short.

Speaker Change: Our clinical experience within adult that aligns with what we observed in the preclinical data.

Speaker Change: An exploratory analysis of the phase II emerge data showed that the exposure to Intelsat.

Speaker Change: Correlated both qualitatively and quantitatively with reduction in mutation burden.

Joe: In other words, we observed a decrease in the number and type of mutation. This exploratory analysis showed that long and durable responders tended to have a strong correlation with mutation burden reduction.

Speaker Change: In other words.

Speaker Change: We observed a decrease in the number and type of mutations.

Speaker Change: This exploratory analysis showed that long and durable responders.

Speaker Change: To have a strong correlation with mutation burden reduction.

Joe: We believe that these correlations illustrate the unique mechanism of action of the Natal Looking ahead, we are excited about the upcoming American Society of Clinical Oncology and European Hematology Association annual meetings this June. We have a robust plan in place at these key medical conferences to engage with many of our investigators and thought leaders, and we plan on holding strategic advisory board meetings to discuss our plans and to inform our strategy. We look forward to reconnecting with many of our stakeholders in Chicago and Milan. Additionally, to build on the momentum from these conferences, we plan to continue actively sharing our progress at key venues and in key journals in order to further increase support from the medical and scientific community.

Speaker Change: We believe that this correlation to illustrate the unique mechanism of action of <unk>.

Speaker Change: Looking ahead, we are excited about the upcoming American society of clinical oncology and European Hematology Association annual meeting this June.

Speaker Change: We have a robust plan in place at these key medical conferences to engage with many of our investigators and thought leaders and we plan on holding strategic advisory board meetings to discuss our claims and to inform our strategies.

Speaker Change: We look forward to reconnecting with many of our stakeholders in Chicago and Milan next month.

Speaker Change: Additionally.

Speaker Change: Build on the momentum from these conferences, we plan to continue actively sharing our progress and key venues and in key journals in order to further increase support from the medical and scientific communities.

Joe: We continue to receive in the Telstat research interest from investigators and given its unique mechanism of action, there is eagerness to evaluate in the Telstat in new settings as well as new indications. As Don and Jim mentioned, our focus and top priority remains U.S. commercialization, and we intend to be disciplined in how we deploy our resources. In the EU, we are working closely with the commercial team, and we intend to stand up and access programs to provide ritalin to eligible patients with low risk and intermediate 1 MDS.

Speaker Change: We continue to receive in the Tulsa research interests from investigators.

Speaker Change: And given its unique mechanism of action there is eagerness to evaluate in the Tel set in new settings, as well as new indications.

Speaker Change: As Don and Jim mentioned, our focus and top priority remains U S commercialization and we intend to be disciplined in how we deploy our resources.

Speaker Change: In the EU, we are working closely with the commercial team and we intend to stand up and access programs can provide great talent to eligible patients with low risk and intermediate one mds.

Joe: I'd also like to provide an update on our IMPACT-MF Phase III trial in relapsed refractory myelofibrosis and discuss why we're excited about expanding in the telstat in this indication. As you know, we basically impact NF phase 3 trial on our single arm phase 2 trial in the same JAK inhibitor relapse refractory myelofibrosis population. In that trial, we saw a strong signal regarding prolonged survival and decreased bone marrow fibrosis after treatment, suggesting the potential for disease modification. First, we observed a prolongation of survival of almost threefold when compared with a historical cohort. Second, we observed decreased bone marrow fibrosis or complete reversal after treatment with the Natal These significant observations gave us confidence in pursuing the registrational study in relapsed refractory myelocytosis.

Speaker Change: I'd also like to provide an update on our impact MF phase III trial in relapsed refractory myelofibrosis and discuss why we are excited about extending and eutelsat in this indication.

Speaker Change: As you know we base the impact MF phase III trial on our single arm phase II trial in the same JAK inhibitor relapsed refractory myelofibrosis population.

Speaker Change: In that trial.

Speaker Change: So a strong signal regarding prolonged survival and decreased bone marrow fibrosis after treatment, suggesting the potential for disease modification.

Speaker Change: We observed a prolongation of survival of almost three fold when compared with the historical cohort.

Speaker Change: Second we observe decrease bone marrow fibrosis or complete reversal after treatment with an Intel step.

Speaker Change: This significant observations gave us confidence in pursuing the Registrational study in relapsed refractory myelofibrosis.

Joe: Our confidence also stems from the unique mechanism of action within the Taos Panomeres are repetitive 5'-3' DNA sequences at the end of chromosomes and serve as protective caps that can help maintain the stability and integrity of these chromosomes. Thelomerase is an enzyme that maintains telomere length in rapidly dividing cells. Thelomerase is upregulated in more than 90% of cancers, including myelodysplastic syndrome, NMF, and leads to cells dividing uncontrollably without reaching the Hayflick limit, thereby evading a full Rytel is the first and only telomerase inhibitor approved by FDA for certain lower-risk MDS patients and is being evaluated in relapsed refractory myelofibrosis in a Phase III ongoing trial.

Speaker Change: Our confidence also stems from the unique mechanism of action of <unk>.

Speaker Change: Suddenly is a repetitive lifetime.

Speaker Change: Key prime DNA sequences at the end of chromosomes and served as protective cabs that can help maintain the stability and integrity achieved chromosome.

Speaker Change: <unk> is an enzyme that maintains telomere length.

And rapidly dividing cells.

Speaker Change: <unk> is up regulated in more than 90% of cancers, including Myelodysplastic syndrome, NMS and leads to cell divide uncontrollably without reaching the hayslip limit, thereby exclusives.

Speaker Change: It produces.

Speaker Change: <unk> is the first and only telomerase inhibitor approved by FDA for certain lower risk Mds patients and is being evaluated in relapsed refractory myelofibrosis in the phase III ongoing trials.

Speaker Change: We are very encouraged with the continued interest and the impact in this phase III trial, which is currently approximately 85% enrolled and expected to be on track to complete enrollment.

Joe: We are very encouraged with the continued interest in the IMPACT-MFA-3 trial, which is currently approximately 85% enrolled and expected to be on track to complete enrollment. Based on current assumptions of death events, we expect the interim analysis to read out in the second half of 2020. It is important to remember that the OS primary endpoint is event-driven, and the timeline for interim and final analyses are tied to the number of deaths.

Speaker Change: Based on current assumptions of death events, we expect the interim analysis to readout in the second half of 2026. It is important to remember the primary endpoint is event driven and the timelines for interim and final analyses are tied to the number of death events.

Joe: The IMPACT-MF Phase 3 trial is designed with a 2-to-1 randomization, and the number of patients on the INITEL-STAT arm are double the number of patients on the best available therapy In addition to this Phase 3 trial, we also have the IMPROVE-MF Phase 1 trial, which is a front-line myelofibrosis study of the metastat in combination with JAKA. This trial completed the dose escalation. We were encouraged to be able to dose roxolitinib and imetelclaz at the maximum intended doses of each without observed MTD. We also observed fewer cytopenias than seen in the IMERG trial. The second stage of the study is enrolling now, and we are seeing excitement from the investigator community for this combination and its potential for patients with MS. This is a great opportunity for patients with unmet need and for GERON continued growth.

Speaker Change: The impact of <unk> Phase III trial is designed with a two to one randomization and the number of patients on the in the post that on our double the number of patients on the best available therapy arm.

Speaker Change: In addition to this phase III trial, we also have the improve MFS phase one trial, which is a frontline myelofibrosis study of <unk> in combination with JAK inhibitors.

Speaker Change: This trial completed the dose escalation stage.

Speaker Change: We were encouraged to be able to dose rux, so listen nib, and Intelsat and the maximum intended doses of each without observed in TD.

Speaker Change: We also observed fewer site opinions than seen in the emerge trial.

Speaker Change: The second stage of the study is enrolling now and we are seeing excitement from the investigator community for this combination and the potential for patients with MF.

Speaker Change: This is a great opportunity for patients with unmet need and <unk> continued growth.

Joe: We believe that this is an important opportunity to investigate whether a MATELS test might be able to benefit additional patients with unmet needs.

Speaker Change: We believe that this is an important opportunity to investigate whether in the delta might be able to benefit additional patients with unmet need.

Michelle Robertson: I'll now pass the call to Michelle to review our Q1 financial results. Thank you, Joe, and good morning, everyone. For detailed results from the quarter, please refer to the press release we issued this morning, which is available on our website. As of March 31st, 2025, we had approximately $457.5 million in cash, cash equivalents, restricted cash, and marketable securities, compared to $502.9 million as of December 31st, 2025. Total Net Product Revenue and Total Net Revenue for the three months ended March 31, 2025 were $39.5 million. There were no product or net revenues in the first quarter of last year since Ray Keller was approved by the FDA in June of 2020.

Speaker Change: I'll now pass the call to Michelle to review, our Q1 financial results.

Michelle: Thank you Joe and good morning, everyone. The details of the results for the quarter. Please refer to the press release, we issued this morning, which is available on our website.

Michelle: As of March 31, 2025, we had approximately $457 5 million in cash cash equivalents restricted cash and marketable securities compared to $502 9 million as of December 31, 2024.

Michelle: Total net product revenue and total net revenue for the three months ended March 31, 2025 were $39 4 million.

Michelle: No products are net revenues in the first quarter of last year, considering Palo was approved by the FDA in June of 2024.

Michelle Robertson: As Dawn mentioned, Q1 Ritello Net Revenues were down approximately $8 million from Q4, while demand in the 13-week period through the week ending March 28th was relatively flat versus the prior 13-week period. The lower quarter-over-quarter net revenue is due to the inventory drawdown among our distributors from Q4 into Q1. As a reminder, revenue recognition occurs when specialty pharmacies, specialty distributors, and GPOs receive right-to-buy. Growth to net was similar from Q4 to Q1 and did not significantly contribute to the quarter-over-quarter net revenue. As Jim mentioned, we are encouraged by sales trends since the end of Q1, as we had the highest month-over-month demand growth as of April 25th since last October, representing a 10% increase in the current four-week period compared to the prior four-week period.

Michelle: I've gone mentioned Q1, <unk> net revenues were down approximately $8 million from Q4, while demand in the 13 week period through the week ending March 28 was relatively flat versus the prior 13 week, but.

Michelle: The lower quarter over quarter net revenue is due to the inventory drawdown among our distributors from Q4 into Q1.

Michelle: As a reminder, revenue recognition occurs and specialty pharmacies are stocking distributors and <unk> received breakout growth.

Michelle: Gross to net with similar from Q4 to Q1 and did not significantly contribute to the quarter over quarter net revenue decline.

Michelle: As Jim mentioned, we are encouraged by sales from the end of Q1 as we had the highest month over month demand growth as of April 25th since last October representing a 10% increase in the current four week period compared to the prior four weeks.

Michelle Robertson: Research and Development Expenses for the three months ended March 31st, 2025 were $15.1 million compared to $29.4 million for the same period in 2024. The decrease was primarily due to lower clinical trial costs associated with the wind down of activity in our Phase 3 iMERGE MDS study at the FDA approval of Ritello in 2024, as well as manufacturing and quality costs that were capitalized in the current period now that Ritello has been approved versus being expensed in the prior year period prior to commercial. Selling General and Administrative Expenses for the three months ended March 31, 2025 were $40 million compared to $27.1 million for the same period last year.

Michelle: Research and development expenses for the three months ended March 31, 225 were $15 1 million compared to $29 4 million for the same period in 2024.

Michelle: The decrease was primarily due to lower clinical trial costs associated with the wind down of activity in our phase III emerge Mds study after the FDA approval of <unk> in 2024.

Michelle: As well as manufacturing and quality costs that were capitalized in the current period now that right Tallo has been approved versus being expensed in the prior year period prior to commercialization.

Michelle: General and administrative expenses for the three months ended March 31, 2025, or $40 million compared to $27 1 million for the same period last year. The increase was primarily due to higher personnel expenses related to additional headcount to support the commercialization of a breakout in the U S.

Michelle Robertson: The increase is primarily due to higher personnel expenses related to additional headcount to support the commercialization of Ritello in the U.S. For fiscal year 2025, we still expect our total operating expenses to be in the range of approximately $270 million to $280 million. This includes expenses associated with our continued investment in our Ritello commercialization strategy, investment in commercial supply redundancies, post-marketing commitments, as well as initial preparations to launch Ritello in selected EU countries in 2026, including the HTA evaluation.

Michelle: For fiscal year 2025, we still expect our total operating expenses to be in the range of approximately $270 million to $2 85. This includes expenses associated with our continued investment in our Reits Hello commercialization strategy investment in commercial supplier redundancies.

Michelle: <unk> marketing commitments as well as initial preparations for launch right Tallow and selected EU countries in 2026, including the HCA evaluation process.

Michelle Robertson: We will be able to provide additional details as we approach the planned launch next year, but the initial work associated with launch preparation in the EU is budgeted into our long-term Overall, we are confident that Geron remains in a strong financial position as we continue to integrate commercial strategy refinements outlined by Dawn and Jim, as well as monitor our sales trajectory.

Michelle: We will be able to provide additional details as we approach the clinic launch next year, but the initial work associated with launch preparations.

Michelle: <unk> is budgeted into our long term plans.

Michelle: Overall, we are confident that Iran remains in a strong financial position as we continue to integrate commercial strategy refinements outlined by Tom and Jim as well as monitor our sales trajectory, we will evaluate our timeline for achieving profitability.

Michelle Robertson: We will evaluate our timeline for achieving profit. As a reminder, we have access to additional funding under our debt agreement with Pharmacon.

Michelle: As a reminder, we have access to additional funding under our debt agreement with pharma com if needed.

Unknown Executive: With that, I'll turn it back to Dawn.

Tom: I'll turn it back to Tom.

Unknown Executive: Thank you, Michelle. And thank you all again for joining us today. We believe Ritelo is a differentiated product for the treatment of certain patients with lower risk MDS, a disease with high MND. The first quarter sales were modest by our expectations, and we don't believe this reflects the product's true commercial potential. I want to reiterate our top priority remains U.S. commercialization in making Ritello part of the standard of care for eligible lower risk MDS patients. The Geron team is energized by this responsibility, and we believe that we've made and continue to make the appropriate investments to support the success of our U.S.

Tom: Thank you Michelle and thank you all again for joining US today, we believe <unk> is a differentiated product for the treatment of certain patients with lower risk Mds.

Speaker Change: A disease with high unmet need.

Speaker Change: The first quarter sales were modest by our expectations and we don't believe this reflects the product's true commercial potential.

Speaker Change: Want to reiterate our top priority remains U S commercialization and making mitel low part of the standard of care for eligible lower risk Mds patients. The geron team is energized by this responsibility and we believe that we've made and continue to make the appropriate investments to support the success.

Speaker Change: <unk> of our U S commercial business.

Unknown Executive: commercial business. While it's still early, we're beginning to see a few promising performance indicators and are ready to make diligent and swift adjustments as needed to further improve upon our commercial EU commercialization and access to Immatelstat are significant Geron priorities. We are carefully balancing our desire to make this important medicine available to lower-risk MDS patients in the EU with thoughtful and disciplined resourcing, allowing our team to focus on Ritello's success here in the United States.

Speaker Change: It's still early we're beginning to see a few promising performance indicators and are ready to make diligent and swift adjustments as needed to further improve upon our commercial execution.

Speaker Change: EU commercialization and access to in the towns that are significant tear on priorities. We are carefully balancing our desire to make this important medicine available to lower risk Mds patients in the EU.

Speaker Change: With thoughtful and disciplined resourcing, allowing our team to focus on vitello success here in the United States.

Unknown Executive: And lastly, we're excited as we look towards the future. Our Pivotal Phase 3 trial evaluating Imitelstat in relapsed refractory MS patients with an overall survival and If successful and approved in this setting, could potentially double the commercial opportunity of Rytelo.

Speaker Change: And lastly, we're excited as we look towards the future our.

Speaker Change: Our pivotal phase III trial evaluating <unk> in relapsed refractory MF patients with an overall survival endpoint if successful and approved in this setting could potentially double the commercial opportunity of REIT Tello we.

Unknown Executive: We expect that the interim data analysis could occur as soon as the second half of 2026. We look forward to keeping you informed of our progress across all of these priorities, and we'll now open the line for questions.

Speaker Change: We expect that the interim data analysis could occur as soon as the second half of 2026.

Speaker Change: We look forward to keeping you informed of our progress across all of these priorities and we will now open the line for questions operator.

Operator: Operator. Thank you.

Speaker Change: Thank you if you would like to ask a question. Please press star one on your telephone keypad. If you would like to withdraw your question simply press Star One again please.

Operator: If you would like to ask a question, please do so now. Press star one on your telephone. If you would like to withdraw your question, simply press star 1.

Operator: Please ensure you are not on speakerphone and that your phone is not on mute when called upon. Thank you.

Speaker Change: Please ensure you are not on speakerphone and that your phone is not on mute when called upon thank you.

Speaker Change: Your first question comes from Tara Bancroft with TD Cowen Your line is open.

Tara Bancroft: Your first question comes from Tara Bancroft with TD Cowan. Your line is open. Hi, good morning. So I'm hoping, you know, just with the inventory impacts essentially behind you, demand is improving in recent weeks and an increased number of commercial reps that you have out in the field and and growing through Q3.

Tara Bancroft: Hi, good morning so.

Speaker Change: I'm, hoping you know.

Speaker Change: Just with the inventory impact essentially behind you demand is improving in recent weeks and an increased number of commercial reps that you have out in the field and growing through Q3 can you can you help us understand how you're thinking about Q2 expectations and just the expected cadence for the year as to when these efforts can.

Tara Bancroft: Can you can you help us understand how you're thinking about Q2 expectations and just the expected cadence for the year as to when these efforts can potentially lead to inflection in your view? Thanks.

Speaker Change: Potentially lead to an inflection in your view thanks.

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

Speaker Change: Thanks, Tara it's dawn Bir. Thank you so much for your question, Yes, we're excited about the future and the plans that we've put in place two I'll allow Jim to address your question here, Great Hi, Gerry good morning.

Jim: Great.

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

Speaker Change: In terms of Q1, thanks for acknowledging that.

Speaker Change: Inventory played a factor in explaining the difference between revenues and underlying demand, which grew at about 1% Q1 over Q4.

Speaker Change: A lot of the changes that we're making and we'll make we'll start to have an impact.

Speaker Change: Now and going forward your specific question around the reps.

Speaker Change: Adding the reps, we anticipate they will be in the field beginning in Q3. So we will see their impact later this year, but a couple of the promising data points that we acknowledged on the call were the increase of approximately 300, new ordering sites Q1 over Q4.

Speaker Change: 10% increasing growth.

Speaker Change: April over March.

Jim: So what we anticipate is continued momentum building into Q2 and sustaining throughout the year through 2025.

Speaker Change: What we anticipate is continued momentum building into Q2 and sustaining throughout the.

Speaker Change: The year through 2025, thank you.

Tara Bancroft: Thank you. Okay, thanks so much.

Speaker Change: Okay. Thanks, so much.

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

Greg Harrison: Next question comes from Greg Harrison with Scotiabank. Your line is open. Good morning, this is Teresa Vitelli. I'm for Greg Harrison. Thanks for taking our question.

Speaker Change: Good morning, turning to my tally on for Greg Harrison and thanks for taking our question.

Teresa Vitelli: I'm just curious if you can comment on your commercial efforts to drive the assessment of efficacy for patients on these patterns set to an earlier stage in order to help promote switching to Rytelo? And maybe what are KOL citing as their reasoning behind any hesitation in switching patients from standard of care? And prescribing Rytelo and earlier lines of therapy. Thank you. Therese, good morning. And thank you for your question.

Speaker Change: I'm just curious if you can comment on your commercial efforts to do what drives the assessment of efficacy for patients on these patterns that to an earlier stage in order to help.

Promote switching to write Hello.

Speaker Change: And maybe what our kols, citing as their reasoning behind on any hesitation in switching patients from standard of care and prescribing right Rachel though in earlier lines of therapy.

Speaker Change: No.

Speaker Change: Theresa Good morning, and thank you for your question I think maybe to address your question, we'll start first with Jim, but I think Joe could provide a great perspective from the medical affairs point of view, So I'll, let I'll, let Jim take this sure let's talk first about.

Jim: I think maybe to address your question, we'll start first with Jim. But I think Joe could provide a great perspective from the medical affairs point of view. So I'll let I'll let Jim take this off. Sure. Let's talk first about perceptions, behaviors and results. We do something called ATU market research awareness, trial utilization. And it all begins with awareness. What we see in the market research is that when physicians are aware of Rytello's product profile, they view it favorably compared to those that don't understand it. And that holds for both efficacy as well as cytopenia management.

Speaker Change: Perceptions behaviors and results, we do something called Apu market research awareness trial utilization and it all begins with the awareness what we see in the market research is that when physicians are aware of <unk> product profile, they view favorably compared to those that.

Speaker Change: I don't understand it and that holds for both efficacy as well as the Cytopenia management and our most recent <unk>, we saw a nice share.

Jim: In our most recent ATU, we saw a nice shift of cytopenia management, especially among those that have used Rytello being viewed as much more manageable than those that haven't used it. In terms of efficacy, one of the nice data points that we saw in the most market, most recent market research, is that the perceptions around second line RS negative has definitely shifted and increased as a source of product differentiation. The reason why I bring this up is first to acknowledge the messages delivered by the field force are resonating with the physicians. We expect to see those perceptions to translate into changes in behavior.

Speaker Change: Cytopenia management.

Speaker Change: Especially among those that have huge right.

Speaker Change: <unk> viewed as much more manageable and those that haven't used it in terms of efficacy one of the nice data points that we saw in the most market. Most recent market research is that the perceptions around second line Rs negative has definitely shifted and increased as a source of product.

Speaker Change: <unk> the reason why I bring this up is first we acknowledge the messages delivered by the field force are resonating with the physicians, we expect to see those perceptions to translate into changes in behavior. The data point that I shared on the call which is very positive is that in the most recent data.

Jim: The data point that I shared on the call, which is very positive, is that in the most recent data, we had about 20% utilization in first and second line, which is an increase over the previous results. These are all leading indicators for sustained growth. And I want to again acknowledge our customer facing teams, both the CAMs as well as the oncology clinical educators, for delivering the message because, as we highlighted earlier, when the message is delivered, there is impact.

Speaker Change: We had about 20% utilization in first and second line, which is an increase over the previous.

Speaker Change: Our results. These are all leading indicators for sustained.

Speaker Change: Sustained growth.

Speaker Change: Want to again acknowledge our customer facing teams both the cans as well as the oncology clinical educators for delivering the message because as we highlighted earlier when the messages delivered there is impact.

Joe: And next, gentlemen, I got to go. Maybe to complement Jim's answer, you specifically asked about the post-Lispatercept. Obviously, as we know, in the iMERGE study, there was a limited number of patients who had received Lispatercept, given that it was in the early days of its approval. However, we did have subsequent trials that did include patients who had received Lispatercept. And we presented data at ASH last December that showed the activity of Imitalstat, post-CSA, post-Lispa, heavy transfusion burden, mutation burden. All these patients responded in a similar manner. There will be, obviously, more patients, you know, from the real-world data that we are collecting that will be providing additional information about that specific topic.

Speaker Change: And ladies and gentlemen.

Speaker Change: Okay.

Speaker Change: Maybe to complement Jim's answer your specific at the postman status up obviously.

Speaker Change: As we know in the emerge study that was limited.

Speaker Change: <unk> of patients who had received was Patterson given that it was in the early days of its own.

Speaker Change: Approval.

Speaker Change: However, we did have.

Speaker Change: Subsequent trials that did include.

Speaker Change: Patients who have received the status and we presented data at Ash last December that showed the activity of <unk> plus.

Speaker Change: <unk> post new Spa.

Speaker Change: Have a transfusion burden mutation burden.

Speaker Change: All these patients who responded.

Speaker Change: A similar manner.

Speaker Change: There will be obviously more patients.

Speaker Change: From the real World.

Speaker Change: Data that we are conducting that we'll be providing additional information about the specific topic in terms of hesitancy as Jim has mentioned and I reemphasize physicians, who are using an adult.

Joe: In terms of hesitancy, as Jim has mentioned and I reemphasized, physicians who are using Imitalstat have experienced the positive benefit of this on their patients. And that is encouraging. And the efficacy is somewhat unparalleled in this space, where we are seeing robust hemoglobin rises and patients' quality of life improving.

Speaker Change: Hedge.

Speaker Change: <unk> the positive benefit of this.

Speaker Change: This on their patients and that is encouraging.

Speaker Change: The efficacy is.

Speaker Change: What unparalleled in this space, where we are seeing robust hemoglobin advisors and patient quality of life and improving.

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

Peter Lawson: Lawson of Barclays. Your line is Great. Thank you so much, Gil.

Speaker Change: Great. Thank you so much.

Speaker Change: Jim.

Peter Lawson: If you could walk through the inventory issue, was that due to a distributor kind of stocking in 4Q, just the dynamics there that we should be thinking about as the inventory been burned through and do you think that's correct? Thanks Peter.

Speaker Change: Maybe you could walk through the inventory.

Speaker Change: Sue.

Speaker Change: Was that due to distribute to kind of stocking <unk> dynamics that we should be thinking about as it was.

Speaker Change: Inventory being burnt through and do you think thats correct.

Peter Lawson: Thanks Peter.

Peter Lawson: First I want to acknowledge that there are several factors that contributed to the higher inventory. First, prior to the holidays we were on a growth trend and so many of our SPs and SDs were using history to project the future going forward. So as the trend started to flatten the inventory increased. Second factor, as we talked about before, was some level of seasonality that affected our products as well as other products in our category. And then the third thing is perhaps there was some anticipation of pricing or reimbursement issues, which is not specific to Vitello, but affects all buy and build products.

Peter Lawson: Firstly I wanted to acknowledge that there are several factors that contributed to the higher inventory first our priority is the holidays, we run our growth trend and so many of our SP and SD <unk> for use in history to project their future going forward, so as that trend started to flatten.

Peter Lawson: Inventory increased second factor as we've talked about before with some level of seasonality that affected our product as well as other products in our category and then the third thing is perhaps there was some anticipation of <unk>.

Peter Lawson: Rising or reimbursement issues, which is not.

Peter Lawson: Specific to vitello, but FX, all buy and bill products.

Peter Lawson: So while the inventory was probably at the higher end of the range towards the end of the year, we did start to draw down that inventory and that explains the difference between the drop in net revenues, yet the 1% increase in demand. Thanks for the question, Peter.

Peter Lawson: While the.

Peter Lawson: Inventory was probably at the higher end.

Peter Lawson: The range towards the end of the year, we did start to draw down that inventory and that explains the difference between the drop in net revenues yet the 1% increase in demand. Thanks for the question Peter.

Peter Lawson: Great.

Speaker Change: Great and do you think that's kind of stabilized and kind of issues with I guess slowed in the next 50 pull through.

Peter Lawson: And you think that kind of stabilized and kind of issues with, I guess, slow than expected pull through and stocking, do you think that's in a good spot for 2Q? We do, Peter. Thanks. Yes. Great, okay, thank you.

Peter Lawson: And in store can do you think that's in a good spot for <unk>.

Peter Lawson: We do Peter Thanks.

Peter Lawson: Yes.

Peter Lawson: Great. Okay. Thank you and then.

Peter Lawson: And then on of the, there's like, I think you mentioned like 1,300 high priority HCPs. How many are currently covered by the field team? And how frequently do they call and kind of where do you want that metric to be? in the second half of this year.

Speaker Change: The like I think you mentioned 1300 high priority Hcp's.

Peter Lawson: Many are currently covered by the <unk> team and.

Speaker Change: How frequently do they call them.

Peter Lawson: Where do you want the metric to be.

Speaker Change: In the second half of this year.

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

Speaker Change: Peter we're not going to give the specifics, but certainly by an increase in our field reps by 20%, which I previously stated that our field was 50, we increased it to 60 at least amongst the key account manager that allows us to go deeper and with more frequency to our higher decile.

Speaker Change: <unk> position. So in terms of the 1300 they are definitely on the target list and there are some more.

Speaker Change: Above and beyond that on the target list as well.

Unknown Executive: For more information visit www.FEMA.gov Questions?

Speaker Change: The next question comes from <unk> Gill with Needham <unk> Company. Your line is open.

Unknown Executive: Your line is open.

Unknown Executive: Good morning, everyone. And thanks for taking our questions. So maybe just one specific to treating physicians here. You mentioned the kind of feedback you've been receiving. Have there been any specific pushbacks of, you know, physicians who were less interested and have a follow on? Going back to the market research, what I would say is for those specifically that have not used Ritello or not necessarily educated by our key account managers, some of the often cited barriers are cytopenias or not having patients. However, that number dramatically changes when you talk about those physicians that have treated and or know about Ritello.

Gill: Good morning, everyone and thanks for taking our questions. So.

Speaker Change: Let me just one specific too.

Speaker Change: Treating physicians here.

Speaker Change: You mentioned the kind of feedback you've been receiving have there been any specific pushback physicians who were less interested.

Speaker Change: A follow on.

Speaker Change: Going back to the market research what I would say is for those specifically that were.

Speaker Change: Not you have not used <unk> or not necessarily.

Speaker Change: <unk> by our key account managers some of the often sided.

Speaker Change: Barriers are cytopenia are not having patients however that number dramatically changes when you talked about those physicians that have treated and or know about right. Tyler. So we believe that continued reach frequency delivery of strong messages, especially to our.

Jim: So we believe that continued reach frequency, delivery of strong messages, especially to our targeted accounts will start to change those dynamics. But what I would key in on is the fact that physicians that have used it and are aware of Ritello have a much more favorable view of the product profile and the utilization pattern. Just to hone in on that. Sorry, go ahead.

Speaker Change: Targeted accounts will start to change those dynamics.

Speaker Change: Kian on us.

Speaker Change: The fact that <unk>.

Speaker Change: Missions that have used it and are aware.

Speaker Change: <unk> has a must have a much more favorable view of the product profile and the utilization patterns.

Speaker Change: Just to hone in on.

Speaker Change: I'm sorry go ahead, if I may.

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

Speaker Change: Yes, if I may add actually we've had several engagements with physicians who have not used right Hello.

Speaker Change: And the main reason that they have accused it as Jim said is they are not aware of the full potential or they have heard about the cytopenia.

Speaker Change: And those conversations we've had with many of those type of physicians when we do discuss the mechanism of action and then decide opinions.

Speaker Change: Actually on target due to the mechanism of action.

Speaker Change: The whole attitude shifts and the potential for disease modification drug for these patients.

Speaker Change: It does impact the physician thinking and potential.

Speaker Change: Utilization in their clinics.

Jim: So just to hone in on that message, would you say the main barrier, you know, energy barrier here is just to get physicians to start treating? Is that fair? I mean, yeah, you have to work to One second, Jim.

Speaker Change: So just to hone in on that message would you say the main barrier energy barrier here is just to get physicians to start treating.

Speaker Change: Fair.

Speaker Change: Yes.

Speaker Change: Yes.

Speaker Change: One second Jim.

Joe: I mean, when REBLUZA was launched, there was this so-called apathy among physicians converting from ESAs to spatter sets. To this day, we see patients, in particular in the community setting, on ESAs, even with high EPO levels, over 500, or patients who have failed ESAs. That's been, you know, the pattern for 20 plus years in the clinics. And that's the reason for many of those barriers that we are seeing initially in the spatter set, you know, journey. And some of that we're seeing for the Imitel set as well. Go ahead, Jim.

Speaker Change: When <unk> was launched there was this so called apathy among physicians converting from Esa to Patterson.

Speaker Change: To this day, we see patients and.

Particularly in the community setting.

Speaker Change: Assay, even with high Epo levels over 500 patients who have failed Esa.

Speaker Change: Ben.

Speaker Change: Pattern for 20 plus years.

Speaker Change: In the clinic and that's that's the reason for many of those barriers that we are seeing.

Speaker Change: And initially and then looked better said.

Speaker Change: Bernie and some of that we're seeing for the Intelsat themselves go ahead Jim.

Jim: And that's India. Thanks, Joe.

Speaker Change: Nothing to add thanks, Jeff.

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

Speaker Change: Quick one for Michelle.

Speaker Change: Let's see Opex guidance has not changed even though you guys are seem to be investing more in your sales force.

Speaker Change: As this is going to continue or should we expect.

Speaker Change: Maybe a shifting more towards.

Speaker Change: The investment in G&A. Thank you.

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

Speaker Change: Yeah. Thanks.

Speaker Change: You had said previously that we have some levers to pull to maintain our opex guidance.

Speaker Change: Particularly around some of our investment in inventory manufacturing redundancy and so we're going to be looking at all of that but right now we.

Speaker Change: Have included all of the additional investment in commercial and medical.

Speaker Change: And we do not have to change our guidance.

Stephen Willey: For more information visit www.FEMA.gov The next question comes from Stephen Willey of Your line is open. Yeah, good morning. Thanks for taking the questions. Steve, I guess you talked about 900 accounts having order to date. Can you talk to, I guess, where those accounts fit? Prescribing buckets that she talked about are these accounts desal.

Speaker Change: The next.

Speaker Change: <unk> question comes from Stephen Willey of Stifel. Your line is open.

Stephen Willey: Yes, good morning, thanks for taking the questions.

Stephen Willey: I guess you talked about 900 accounts, having ordered to date can you.

Stephen Willey: Talk to I guess, where those accounts fit within.

Stephen Willey: Those prescribing buckets that you've talked about are these accounts, mostly in the top decile, representing 50% of diagnosed patients.

Stephen Willey: And then how does that 900 split out between academic and community.

Jim: And then how does that nine Stephen, thanks for the question. The majority of those accounts represented by the 900 are in fact on our target list. However, there are some that are not on our target list. In terms of the general split, it's reflective of the underlying dynamics, which is approximately 1 3rd in the academic centers and 2 3rds in the community. And what we expect going forward is that with increased personal and non-personal promotions and a focus on KOLs, that we actually grow both simultaneously. But our focus is both. We are focused on both the academic as well as the community.

Stephen Willey: Stephen Thanks for the question.

Stephen Willey: The majority of those accounts represented by the 900 are in fact on our target list. However, there are some that are not on our target list in terms of the.

Stephen Willey: General split it's reflective of the underlying dynamics, which is approximately one third in the academic centers and two thirds in the community and what we expect going forward is that with increased personal and non personal promotion and a focus on kols that we actually grow.

Stephen Willey: <unk> simultaneously, but our focus is both we are focused on both the academic as well as the community. Thanks for the question Stephen.

Jim: Thanks for the question. and then. Can you also just comment in terms of what you're seeing with respect to this PatterSept utilization in the frontline setting, both in terms of RS positive Do you have any sense if these patients are... Ruin ESA as a second line option, or is it just too early into the, was Patterson.

Stephen Willey: Okay and then.

Speaker Change: Could you also just comment in terms of what Youre seeing with respect to Patterson utilization in the frontline setting.

Stephen Willey: Terms of Rs positive and Rs negative.

Stephen Willey: Do you have any sense of these patients are subsequently stepping through an Esa as a second line option or is it just too early into the.

Stephen Willey: Those products are frontline launch to have any real clarity here.

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

Stephen Willey: Thanks for the question, we do have that data we've looked at it from a claims perspective, we haven't necessarily showed it but I think what I could say is that we are seeing growth in the first one with new spatter set based upon the command data.

Stephen Willey: And if that happens.

Stephen Willey: And continues to grow we're expecting.

Stephen Willey: Duration of treatment fairly consistent with their study.

Stephen Willey: In terms of.

Stephen Willey: Which we can't promote specifically post loose powder step our labeled indication is.

Stephen Willey: Esa relapsed refractory or Esa ineligible, however, the NCC guidelines a bit broader.

Speaker Change: The next question comes from Emily partner with H C. Wainwright Your line is open.

Emily Bodnar: The next question comes from Emily Bodnar with HC Wainwright. Your line is open. Hi, thanks for the questions. I'm curious for physicians who have used Drytello and who are not reordering, which I believe you said was about one third of them. Are there any particular reasons that you've heard for why? And maybe if you can comment on this continuation to date, kind of reasonings for those and if that's kind of in line with your clinical data. Yep, thanks, Emily. So in terms of dose interruptions, discontinuation, based upon our patient chart audits and some of our market research, it appears largely that the commercial experience is reflective of the percentages seen in IMERG in our clinical trials.

Speaker Change: Hi, good morning, Thanks for taking my questions.

Speaker Change: I'm curious for physicians, who have used right tullow and who are not reorder rate, which I believe you said it was about one third of them are.

Speaker Change: Are there any particular reason.

Speaker Change: <unk> heard for <unk> and <unk>.

Speaker Change: Maybe if you can comment on discontinuation today.

Speaker Change: Kind of reasoning for that is and if that's kind of in line with your political data expectations.

Speaker Change: Yes, thanks, Emily so in terms of dose interruptions discontinuation based upon our patient chart audits and some of our market research. It appears largely that the commercial experience is reflective of the.

Speaker Change: Percentage is seen in emerge in our clinical trials.

Speaker Change: <unk>.

Jim: And what was the other part of the question? For the one-third of HCPs who you commented did not reorder by TELO, if you can provide any reasoning that you're hearing for that. Nothing specific at this point. It could just be simply a dose interruption due to a cytopenia. As you know, in this buy and bill market, we don't get perfect patient-level data. So what we do is market research, patient chart audits, and we triangulate those insights. And those insights seem to be consistent with iMERGE. There aren't any new surprises in any of the data in market research.

Speaker Change: And what was the other part of the question.

Speaker Change: For the one third of it.

Speaker Change: Looking into your commentary.

Speaker Change: Not reorder color you can provide any reasoning that youre hearing for that.

Speaker Change: Nothing specific at this point it could just be simply dose interruption due to a cytopenia as you know and this buy and bill market, we don't get perfect patient level data. So what we do is market research patient chart audits and we triangulate those insights and those insights scene.

Speaker Change: Be consistent with our emerge there arent any new surprises in any of the data and market research.

Jim: Thank you.

Speaker Change: Okay.

Joe: And lastly, if you can comment on the improved MS data that you're going to have at ASCO, what differences should we be expecting versus the presentation at ASH? I mean, we have. Yeah, we have, you know, started the second cohort, which is the established doses, which are the maximum tolerated doses of both drugs, which was a good surprise, if you will. And there were less cytopenia seen in that, you know, cohort of patients. So we are expanding and we're adding. Additional JAK inhibitors to the combination.

Speaker Change: And then lastly, if you can comment on the improve enough data that you're going to have that also what differences should we be expecting risks presentation at ash.

Speaker Change: Okay.

Speaker Change: I mean, we had.

Speaker Change: So again, we have.

Speaker Change: Yeah.

Speaker Change: Started the second cohort, which is the established doses which are the.

Speaker Change: The maximum tolerated dose of both drugs, which was.

Speaker Change: A good surprise if you will.

Speaker Change: And there were less cytopenia seen in that.

Speaker Change: Cohort of patients. So we are expanding and we are adding.

Speaker Change: Additional JAK inhibitors to the combinations.

Kalpit Patel: The next question comes from Kalpit Patel with B Raleigh. Your line is open. Yes, hey, thanks for taking the question.

Accountants Vitale: The next question comes from Accountants Vitale with B Riley Securities. Your line is open.

Accountant Vitale: Yes, hey, thanks for taking the question.

Michelle Robertson: Maybe first on the inventory part of this. Michelle, I think you previously communicated that, you know, the, the distributors were maintaining two to four weeks of inventory in a channel. So what's what's the day supply today, I guess, or at the end of first quarter? And then I have a follow Sure, thanks, Kalpit. Yeah, so the at the end of Q4, as we mentioned, it was on the higher side. So it was on the higher end of the three and a half week. And as of the end of Q1, it was on the lower end of two, two plus two and a half.

Accountant Vitale: Maybe first on the inventory part of this.

Speaker Change: Michelle I think you previously communicated that.

Accountant Vitale: B.

Accountant Vitale: Distributors were maintaining two to four weeks of inventory in the channel.

Speaker Change: So what's the data supplied today, I guess or at the end of first quarter.

Accountant Vitale: And then I have a follow up.

Speaker Change: Sure. Thanks, Kyle yes so.

Speaker Change: At the end of Q4, as we mentioned it was on the higher side. So it was on the higher end of the three and a half week.

Speaker Change: And as of the end of Q1.

Speaker Change: It was on the lower end of two two plus two and a half weeks.

Jim: Okay, okay, makes sense. And then, at this point in the launch, are you are your new patient starts consistently exceeding the discontinuations? Or are you starting to see some of those early patients who received in a telestat start to roll off and offset the new start? We don't have perfect data on this. Again, we use patient chart audits and marker research. In the buy and bill market, the data isn't at a patient-specific level. But I can tell you, and generally speaking, if 80% of the patients that I described in the previous quarter were third-line plus, the duration of treatment for subsequent lines of therapy tend to be shorter than what we often quote as the median 7.8 months.

Speaker Change: Okay, Okay makes sense.

Speaker Change: Then.

Speaker Change: At this point in the launch.

Speaker Change: Are your new patient starts.

Speaker Change: Distantly exceeding the discontinuation.

Speaker Change: Or are you starting to see some of those early patients who received <unk> start to roll off and off net.

Speaker Change: The new starts.

Speaker Change: We don't have perfect data on this again, we use patient chart audits and Mark to research in the buy and Bill market the day.

Speaker Change: Data is at.

At a patient specific level, but I can tell you and generally speaking.

Speaker Change: If 80% of the patients that I described in the previous quarter, where third line plus the duration of treatment for subsequent lines of therapy tend to be shorter than what we often quote as the median seven eight months. So your math is correct as they roll off.

Jim: So your math is correct as they roll off. New patient starts after fill the funnel and continue to drive. The promising data that I shared on this call is that, you know, based on most recent new patient starts number 25%, approximately 25%, and we're in first and second line.

Speaker Change: New patient starts out to build the funnel and continue to drive the promising data that I shared on this call is that.

Speaker Change: Based upon the most recent new patient starts number 25% approximately 25% and we're in first and second line. So the earlier we move.

Jim: So the earlier we move up in lines of therapy, we generally expect longer duration of treatment.

Speaker Change: And lines of therapy, we generally expect longer duration of treatment.

Michelle Robertson: Okay, and then one one financial question. You reported 19.8 million net loss for the quarter and had about 45 million in cash burn. Maybe walk us through what drove that incremental 25 million in outflow. Was this any capital changes or inventory build or Um, well, Q1 cash burn is always higher due to payouts of bonuses and some early investment. Yes, on the inventory side. That was from, you know, from the. Got it.

Speaker Change: Okay, and then one financial question.

Speaker Change: We reported $19 8 million net loss for the quarter end.

Speaker Change: About $45 million in cash burn.

Speaker Change: Maybe walk us through what drove that incremental 25 million outflow was this capital changes or inventory build or something else.

Speaker Change: Q1 cash burn is always higher due to payout of bonuses.

Speaker Change: Bonuses.

Speaker Change: And some early investment, yes on the inventory side.

Speaker Change: That was front.

Speaker Change: Sure.

Speaker Change: Yes.

Speaker Change: Got it thank you.

Unknown Executive: Thank you.

Faisal Khurshid: The next question.

Alex: The next question comes from Alex <unk> with Leerink Partners. Your line is open.

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

Alex: Hey, guys. Thank you for taking the question just wanted to ask about this 10% demand increase that you've seen in April could you comment on sort.

Alex: Sort of how sustainable you see that increase to be going forward and also like how reliably do you expect that to translate into like true revenue growth.

Speaker Change: Thanks, Paul So that's a great question. It's one data point, it's a promising data point April over March what I can tell you is that.

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

Alex: From a salesforce.

Speaker Change: Perspective and market research.

Speaker Change: Delivering the right message to the.

Speaker Change: Physicians is leading to success, we saw the changes and perceptions that I described earlier, we're seeing at least this one data point of April over March growth.

Speaker Change: The key for all of US is to sustain that growth and build the momentum going forward. Our expectation is that as the team that we returned to growth based upon strong execution.

Speaker Change: Got it thanks.

Unknown Executive: Thanks.

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

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

Speaker Change: Okay.

Speaker Change: [noise].