Q2 2026 Geron Corp Earnings Call
Operator: Hello, welcome to the Geron Corporation Q2 2026 earnings call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to turn the call over to Dawn Schottlandt, SVP, Investor Relations and Corporate Affairs.
Operator: Hello, welcome to the Geron Corporation Q2 2026 earnings call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to turn the call over to Dawn Schottlandt, SVP, Investor Relations and Corporate Affairs.
Speaker #1: Hello, and welcome to the GERON CORP's second quarter 2026 earnings call. At this time, all participants are in a listen-only mode, after question-and-answer session.
Speaker #1: now like to turn the call raised. To withdraw your question, please SVP, investor relations and corporate affairs.
Speaker #2: Good morning, everyone. Welcome to Geron Corp's second quarter 2026 earnings conference call. Before we begin, please note that during the course of this presentation and question-and-answer session, we will be making forward-looking statements regarding future events, performance, plans, expectations, and other projections, including those related to our 2026 financial guidance, our current retail commercialization strategy, and related opportunities in the U.S.
Dawn Schottlandt: Good morning, everyone. Welcome to the Geron Corporation Q2 2026 Earnings Conference Call. Before we begin, please note that during the course of this presentation, and question and answer session, we will be making forward-looking statements regarding future events, performance, plans, expectations, and other projections, including those related to our 2026 financial guidance, our current Rytelo commercialization strategy and related opportunities in the US and the EU, the therapeutic potential of Rytelo, other anticipated clinical and commercial events, and related timelines, the sufficiency of our financial resources, and other statements that are not historical fact, which of course involves risks and uncertainties that could cause actual events, performance, and results to differ materially from those contained in these forward-looking statements.
Dawn Schottlandt: Good morning, everyone. Welcome to the Geron Corporation Q2 2026 Earnings Conference Call. Before we begin, please note that during the course of this presentation, and question and answer session, we will be making forward-looking statements regarding future events, performance, plans, expectations, and other projections, including those related to our 2026 financial guidance, our current RYTELO commercialization strategy and related opportunities in the US and the EU, the therapeutic potential of RYTELO, other anticipated clinical and commercial events, and related timelines, the sufficiency of our financial resources, and other statements that are not historical fact, which of course involves risks and uncertainties that could cause actual events, performance, and results to differ materially from those contained in these forward-looking statements.
Speaker #2: and the EU, the therapeutic potential of Rytello, other anticipated clinical and commercial events, and related timelines, the sufficiency of our financial resources, and other statements that are non-historical fact.
Speaker #2: Which, of course, involves risk and uncertainties that could cause actual events, performance, and results to different materially from those contained in these forward-looking statements.
Speaker #2: Therefore, I refer you to the risk and uncertainties described in today's earnings release and under the heading Risk Factors and GERON's most recent periodic report filed with the SEC, which identify important factors that could cause actual results to differ materially from those contained in these forward-looking statements, and feature updates to GERON's risk and uncertainties disclosures, including in its upcoming quarterly report on Form 10-Q.
Dawn Schottlandt: I refer you to the risks and uncertainties described in today's earnings release, and under the heading Risk Factors in Geron's most recent periodic report filed with the SEC, which identify important factors that could cause actual results to differ materially from those contained in these forward-looking statements and future updates to Geron's risks and uncertainties disclosures, including in its upcoming quarterly report on Form 10-Q. Geron undertakes no duty or obligation to update its forward-looking statements. Joining me on today's call are several members of Geron's management team. Harout Semerjian, Chief Executive Officer, Ahmed ElNawawi, our Chief Commercial Officer, Dr. Joseph Eid, Executive Vice President of Research and Development, and Chief Medical Officer, and Michelle Robertson, our Chief Financial Officer. I'll turn the call over to Harout to discuss Geron's progress and strategy.
Dawn Schottlandt: I refer you to the risks and uncertainties described in today's earnings release, and under the heading Risk Factors in Geron's most recent periodic report filed with the SEC, which identify important factors that could cause actual results to differ materially from those contained in these forward-looking statements and future updates to Geron's risks and uncertainties disclosures, including in its upcoming quarterly report on Form 10-Q. Geron undertakes no duty or obligation to update its forward-looking statements. Joining me on today's call are several members of Geron's management team. Harout Semerjian, Chief Executive Officer, Ahmed ElNawawi, our Chief Commercial Officer, Dr. Joseph Eid, Executive Vice President of Research and Development, and Chief Medical Officer, and Michelle Robertson, our Chief Financial Officer. I'll turn the call over to Harout to discuss Geron's progress and strategy.
Speaker #2: GERON undertakes no duty or obligation to update its forward-looking statements. Joining me on today's call are several members of GERON's management team: Harout Semerjian, Chief Executive Officer; Ahmed ElNawawi, our Chief Commercial Officer; Dr. Joseph Eid, Executive Vice President of Research and Development and Chief Medical Officer; and Michelle Robertson, our Chief Financial Officer.
Speaker #2: With that, I'll turn the call over to Harout to discuss Geron's progress and strategy.
Speaker #3: Thank you, Dawn, and good morning, everyone. Our second quarter results demonstrate the continued progress we are making and the momentum we are building as we execute our strategy outlined at the beginning of the year.
Harout Semerjian: Thank you, Dawn, good morning, everyone. Our Q2 results demonstrate the continued progress we are making, and the momentum we are building as we execute our strategy outlined at the beginning of the year. We delivered another quarter of net revenue growth, expanding Rytelo's reach to more eligible patients, strengthened the clinical evidence supporting Rytelo, continued investing in future growth opportunities, all while remaining financially disciplined. Let me start with our commercial performance. Q2 net revenue increased 17% year over year and 11% quarter over quarter to $57.5 million. Through the H1 2026, net revenue grew by approximately 24% compared to the same period a year ago, demonstrating sales momentum as our refocused commercial strategy gains traction. During the quarter, we continued to expand awareness and education among healthcare professionals, with a focus on identifying appropriate second-line patients.
Harout Semerjian: Thank you, Dawn, good morning, everyone. Our Q2 results demonstrate the continued progress we are making, and the momentum we are building as we execute our strategy outlined at the beginning of the year. We delivered another quarter of net revenue growth, expanding RYTELO's reach to more eligible patients, strengthened the clinical evidence supporting RYTELO, continued investing in future growth opportunities, all while remaining financially disciplined. Let me start with our commercial performance. Q2 net revenue increased 17% year over year and 11% RYTELO to $57.5 million. Through the H1 2026, net revenue grew by approximately 24% compared to the same period a year ago, demonstrating sales momentum as our refocused commercial strategy gains traction. During the quarter, we continued to expand awareness and education among healthcare professionals, with a focus on identifying appropriate second-line patients.
Speaker #3: We delivered another quarter of net revenue growth, expanding Rytello's reach to more eligible patients, strengthened the clinical evidence supporting Rytello, continued investing in future growth opportunities, all while remaining financially disciplined.
Speaker #3: Let me start with our commercial performance. Second-quarter net revenue increased 17% year over year, and 11% quarter over quarter, to $57.5 million. Through the first half of 2026, net revenue grew by approximately 24% compared to the same period a year ago, demonstrating sales momentum as our refocused commercial strategy gains traction.
Speaker #3: During the quarter, we continued to expand awareness and education among healthcare professionals, with a focus on identifying appropriate second-line patients. At EHA, we presented the first real-world evidence study of Rytelo in lower-risk MDS, with findings that were generally consistent with results from our Phase 3 iMERGE trial and further validated Rytelo's profile in a broader patient population.
Harout Semerjian: At EHA, we presented the first real-world evidence study of RYTELO in low-risk MDS, with findings that were generally consistent with results from our phase III IMerge trial and further validated RYTELO's profile in a broader patient population. As for operating expenses, we continued to make prudent investment decisions while delivering top-line growth. In H1 2026, our total operating expenses decreased by 4% compared to the same period a year ago, while net revenue increased 24%. With $327 million of cash on hand at the end of Q2, our balance sheet is strong and provides us with the flexibility to continue investing in our commercial business, advance our science, and evaluate opportunistic innovation. As part of that strategy, we recently welcomed Chinmaya Rath as our Chief Business Officer. Chinmaya brings deep business development experience and a proven track record of identifying and executing strategic growth opportunities.
Harout Semerjian: At EHA, we presented the first real-world evidence study of RYTELO in low-risk MDS, with findings that were generally consistent with results from our phase III IMerge trial and further validated RYTELO's profile in a broader patient population. As for operating expenses, we continued to make prudent investment decisions while delivering top-line growth. In H1 2026, our total operating expenses decreased by 4% compared to the same period a year ago, while net revenue increased 24%. With $327 million of cash on hand at the end of Q2, our balance sheet is strong and provides us with the flexibility to continue investing in our commercial business, advance our science, and evaluate opportunistic innovation. As part of that strategy, we recently welcomed Chinmaya Rath as our Chief Business Officer. Chinmaya brings deep business development experience and a proven track record of identifying and executing strategic growth opportunities.
Speaker #3: As for operating expenses, we continued to make prudent investment decisions while delivering top-line growth. In the first half of 2026, our total operating expenses decreased by 4% compared to the same period a year ago, while net revenue increased 24%.
Speaker #3: With $327 million of cash on hand at the end of Q2, our balance sheet is strong and provides us with the flexibility to continue investing in our commercial business, advance our science, and evaluate opportunistic innovation.
Speaker #3: As part of that strategy, we recently welcomed Jemiah Rath as our Chief Business Officer. Jemiah brings deep business development experience and a proven track record of identifying and executing strategic growth opportunities.
Speaker #3: His appointment reflects our commitment to maximizing the value of our current portfolio and building a leading hematology company. Beyond our U.S. focus, we recognize the significant unmet need for patients with low-risk MDS in Europe and beyond, and are exploring gated commercial strategies to bring Rytello to appropriate patients, while maintaining pricing integrity in the U.S.
Harout Semerjian: His appointment reflects our commitment to maximizing the value of our current portfolio and building a leading hematology company. Beyond our US focus, we recognize the significant unmet need for patients with low-risk MDS in Europe and beyond, and are exploring gated commercial strategies to bring RYTELO to appropriate patients while maintaining pricing integrity in the US. We expect to share our European commercialization plans before year-end, as previously stated. Turning to our phase III IMpactMF trial in relapsed/refractory myelofibrosis. Over H1 2026, we have proactively engaged with regulatory authorities and external experts to ensure the interim analysis design is adequate to support registration, should the DMC recommend unblinding for positive efficacy. As such, we are evaluating a modification to the event threshold for the interim analysis. At this time, our projected timelines remain unchanged. We will communicate any changes to these projections as appropriate.
Harout Semerjian: His appointment reflects our commitment to maximizing the value of our current portfolio and building a leading hematology company. Beyond our US focus, we recognize the significant unmet need for patients with low-risk MDS in Europe and beyond, and are exploring gated commercial strategies to bring RYTELO to appropriate patients while maintaining pricing integrity in the US. We expect to share our European commercialization plans before year-end, as previously stated. Turning to our phase III IMpactMF trial in relapsed/refractory myelofibrosis. Over H1 2026, we have proactively engaged with regulatory authorities and external experts to ensure the interim analysis design is adequate to support registration, should the DMC recommend unblinding for positive efficacy. As such, we are evaluating a modification to the event threshold for the interim analysis. At this time, our projected timelines remain unchanged. We will communicate any changes to these projections as appropriate.
Speaker #3: We expect to share our European commercialization plans before year-end, as previously stated. Turning to our Phase III impact MF trial in Relapse Refractory Myelofibrosis, over the first half of 2026, we have proactively engaged with regulatory authorities and external experts to ensure the internal analysis design is adequate to support registration, should the DMC recommend unblinding for positive efficacy.
Speaker #3: As such, we're evaluating a modification to the event threshold for the interim analysis, at this time our projected timelines remain unchanged, we will communicate any changes to these projections as appropriate.
Speaker #3: As we look to the second half of the year, we remain focused on executing across each of our strategic priorities including growing Rytello demand.
Harout Semerjian: As we look to the H2 of the year, we remain focused on executing across each of our strategic priorities, including growing RYTELO demand. Based on our solid net revenue performance in the H1 of the year, we anticipate coming in at the mid to high end of our full year 2026 RYTELO net product revenue guidance range of $220 to 240 million. We continue to expect total operating expenses for 2026 in the range of $230 to 240 million. We are confident in our team, strategy, and operating model, and encouraged by the momentum we have generated through the H1 of the year. Most importantly, we are committed to reaching more eligible patients with low-risk MDS and making a meaningful difference in their lives. With that, I will turn it over to ElNawawi to provide more detail on RYTELO's commercial performance and our execution.
Harout Semerjian: As we look to the H2 of the year, we remain focused on executing across each of our strategic priorities, including growing RYTELO demand. Based on our solid net revenue performance in the H1 of the year, we anticipate coming in at the mid to high end of our full year 2026 RYTELO net product revenue guidance range of $220 to 240 million. We continue to expect total operating expenses for 2026 in the range of $230 to 240 million. We are confident in our team, strategy, and operating model, and encouraged by the momentum we have generated through the H1 of the year. Most importantly, we are committed to reaching more eligible patients with low-risk MDS and making a meaningful difference in their lives. With that, I will turn it over to ElNawawi to provide more detail on RYTELO's commercial performance and our execution.
Speaker #3: Based on our solid net revenue performance in the first half of the year, we anticipate coming in at the mid to high end of our full year 2026 Rytello net product revenue guidance range of $220 to $240 million.
Speaker #3: We continue to expect total operating expenses for 2026 in the range of $230 to $240 million. We're confident in our team strategy and operating model, and encouraged by the momentum we have generated through the first half of the year.
Speaker #3: Most importantly, we're committed to reaching more eligible patients with low-risk MDS and making a meaningful difference in their lives. With that, I'll turn it over to Nawawi to provide more detail on Rytello's commercial performance and our execution.
Speaker #4: Thank you, Harout. We delivered solid Rytelo net revenue growth in the second quarter, marking our third straight quarter of demand growth. We continued to execute on our commercial strategy to build sustainable growth and long-term value.
Ahmed ElNawawi: Thank you, Harout. We delivered solid RYTELO net revenue growth in Q2, marking our third straight quarter of demand growth, and continued to execute on our commercial strategy to build sustainable growth and long-term value. In Q2, we achieved 5% demand growth for RYTELO compared to the Q1 of this year, and an 8% increase in prescribing accounts, expanding our footprint to approximately 1,575 accounts since launch. First and second-line patient starts on a rolling 12-month basis was 34%. These results reflect the steady execution of our refocused commercial strategy. As awareness continues to grow, more appropriate RYTELO patients are being identified earlier in their treatment journey. We believe the second line, lower-risk MDS setting, represents a significant opportunity to bring RYTELO to more patients, where we estimate there to be around 8,000 eligible patients in the US.
Ahmed ElNawawi: Thank you, Harout. We delivered solid RYTELO net revenue growth in Q2, marking our third straight quarter of demand growth, and continued to execute on our commercial strategy to build sustainable growth and long-term value. In Q2, we achieved 5% demand growth for RYTELO compared to the Q1 of this year, and an 8% increase in prescribing accounts, expanding our footprint to approximately 1,575 accounts since launch. First and second-line patient starts on a rolling 12-month basis was 34%. These results reflect the steady execution of our refocused commercial strategy. As awareness continues to grow, more appropriate RYTELO patients are being identified earlier in their treatment journey. We believe the second line, lower-risk MDS setting, represents a significant opportunity to bring RYTELO to more patients, where we estimate there to be around 8,000 eligible patients in the US.
Speaker #4: In the second quarter, we achieved 5% demand growth for Rytelo compared to the first quarter of this year, and an 8% increase in prescribing accounts, expanding our footprint to approximately 1,575 accounts since launch.
Speaker #4: First and second-line patient starts on a rolling 12-month basis was 34%. These results reflect the steady execution of our refocused commercial strategy. As awareness continues to grow, more appropriate Rytello patients are being identified earlier in their treatment journey.
Speaker #4: We believe the second-line lower-risk MDS setting represents a significant opportunity to bring Rytello to more patients. Where we estimate there to be around 8,000 eligible patients in the U.S.
Speaker #4: Our commercial strategy remains focused on initiatives that we believe will drive long-term adoption of Rytelo. We’re prioritizing high-volume community treatment centers, identifying appropriate patients earlier in their treatment journey, strengthening account management, and using targeted omnichannel engagement to deliver consistent, evidence-based messaging across healthcare professionals’ preferred channels.
Ahmed ElNawawi: Our commercial strategy remains focused on initiatives that we believe will drive long-term adoption of RYTELO. We are prioritizing high-volume community treatment centers, identifying appropriate patients earlier in their treatment journey, strengthening account management, and using targeted omni-channel engagement to deliver consistent evidence-based messaging across healthcare professionals' preferred channels. These efforts continue to increase awareness, build HCP confidence in RYTELO, and support its positioning as the standard of care in the second-line setting. In addition to our strategy, strong fundamentals, including RYTELO's broad label, NCCN treatment guidelines, growing real-world evidence, and data from the IMerge trial provide a solid foundation for continued adoption in low-risk MDS. As physicians' experience and awareness continue to build, we believe we are well-positioned to accelerate demand growth and bring RYTELO to more eligible lower-risk MDS patients. I now turn this over to Joe to discuss our medical and scientific engagement efforts.
Ahmed ElNawawi: Our commercial strategy remains focused on initiatives that we believe will drive long-term adoption of RYTELO. We are prioritizing high-volume community treatment centers, identifying appropriate patients earlier in their treatment journey, strengthening account management, and using targeted omni-channel engagement to deliver consistent evidence-based messaging across healthcare professionals' preferred channels. These efforts continue to increase awareness, build HCP confidence in RYTELO, and support its positioning as the standard of care in the second-line setting. In addition to our strategy, strong fundamentals, including RYTELO's broad label, NCCN treatment guidelines, growing real-world evidence, and data from the IMerge trial provide a solid foundation for continued adoption in low-risk MDS. As physicians' experience and awareness continue to build, we believe we are well-positioned to accelerate demand growth and bring RYTELO to more eligible lower-risk MDS patients. I now turn this over to Joe to discuss our medical and scientific engagement efforts.
Speaker #4: These efforts continue to increase awareness, build HCP confidence in Rytelo, and support its positioning as the standard of care in the second-line setting. In addition to our strategy, strong fundamentals—including Rytelo's broad label, NCCN treatment guidelines, growing real-world evidence, and data from the iMERGE trial—provide a solid foundation for continued adoption in low-risk MDS.
Speaker #4: As physicians experience an awareness continue to build, we believe we are well-positioned to accelerate demand growth and bring Rytello to more eligible lower-risk MDS patients.
Speaker #4: Joe to discuss our medical and scientific engagement efforts.
Speaker #2: Thanks, Nawawi. Scientific engagement and evidence generation remain central to how we support HCP's caring for patients with lower-risk MDS. Building on the data
Joseph Eid: Thanks, Nawawi. Scientific engagement and evidence generation remain central to how we support HCPs caring for patients with lower-risk MDS. Building on the data presented at ASH 2025, anecdotally, we're seeing a consistent increase in awareness of RYTELO and in meaningful scientific dialogue as physicians continue to incorporate emerging data into clinical practice. There is good understanding of the findings suggesting that treatment-emergent cytopenias are consistent with on-target activity and what those insights may mean for patient management within the approved indication. We're also seeing increased interest from leading academic centers in collaborating through investigator-sponsored studies and real-world evidence initiatives. During Q2, this continued dialogue was evident at both ASCO and EHA, where we had the opportunity to share new data and engage directly with the global hematology community.
Joseph Eid: Thanks, ElNawawi. Scientific engagement and evidence generation remain central to how we support HCPs caring for patients with lower-risk MDS. Building on the data presented at ASH 2025, anecdotally, we're seeing a consistent increase in awareness of RYTELO and in meaningful scientific dialogue as physicians continue to incorporate emerging data into clinical practice. There is good understanding of the findings suggesting that treatment-emergent cytopenias are consistent with on-target activity and what those insights may mean for patient management within the approved indication. We're also seeing increased interest from leading academic centers in collaborating through investigator-sponsored studies and real-world evidence initiatives. During Q2, this continued dialogue was evident at both ASCO and EHA, where we had the opportunity to share new data and engage directly with the global hematology community.
Speaker #2: clinical practice. There's good understanding of the findings suggesting that treatment emergent cytopenias are consistent with on-target activity and what those I now turn this over to insights may mean for patient management within the approved indication.
Speaker #2: We're also seeing an increased interest from leading academic centers in collaborating through investigator-sponsored studies and real-world evidence initiatives. During the second quarter, this continued dialogue was evident at both ASCO and EHA where we had the opportunity to share new data and engage directly with the global hematology community.
Speaker #2: We were encouraged by the level of interest and the quality of discussions which reflected growing engagement with Rytello and our broader investigator-sponsored efforts. At EHA, we presented the first real-world evidence study evaluating Rytello in patients with lower-risk MDS.
Joseph Eid: We were encouraged by the level of interest and the quality of discussions, which reflected growing engagement with RYTELO and our broader investigator-sponsored efforts. At EHA, we presented the first real-world evidence study evaluating RYTELO in patients with lower-risk MDS. The investigator-sponsored study, conducted in collaboration with Moffitt Cancer Center, is a two-part retrospective and prospective study designed to evaluate the safety and clinical efficacy of RYTELO in advanced, heavily transfusion-dependent patients with lower-risk MDS, including patients with extensive prior therapies and after luspatercept failure. The data highlighted at EHA was from the retrospective portion of the study. The findings were encouraging and generally consistent with the phase III IMerge trial, reinforcing the safety, efficacy, and tolerability profile of RYTELO in a broader, real-world patient population.
Joseph Eid: We were encouraged by the level of interest and the quality of discussions, which reflected growing engagement with RYTELO and our broader investigator-sponsored efforts. At EHA, we presented the first real-world evidence study evaluating RYTELO in patients with lower-risk MDS. The investigator-sponsored study, conducted in collaboration with Moffitt Cancer Center, is a two-part retrospective and prospective study designed to evaluate the safety and clinical efficacy of RYTELO in advanced, heavily transfusion-dependent patients with lower-risk MDS, including patients with extensive prior therapies and after luspatercept failure. The data highlighted at EHA was from the retrospective portion of the study. The findings were encouraging and generally consistent with the phase III IMerge trial, reinforcing the safety, efficacy, and tolerability profile of RYTELO in a broader, real-world patient population.
Speaker #2: The investigator-sponsored study conducted in collaboration with Moffitt Cancer Center is a two-part retrospective and prospective study designed to evaluate the safety and clinical efficacy of Rytello in advanced, heavily transfusion-dependent patients with lower-risk MDS, including patients with extensive prior therapies and after loospirocepts failure.
Speaker #2: The data highlighted at EHA was from the retrospective portion of the study, the findings were encouraging and generally consistent with the Phase III iMERGE trial reinforcing the safety, efficacy, and tolerability profile of Rytello in a broader real-world patient population.
Speaker #2: The data also showed a trend toward optimal management of cytopenias and improved responses when Rytelo was used within the first three lines of therapy.
Joseph Eid: The data also showed a trend toward optimal management of cytopenias and improved responses when RYTELO was used within the first three lines of therapy. Real-world evidence is an important complement to clinical trial data, helping us better understand how therapies perform in routine clinical practice. These findings add to the growing body of evidence for supporting the use of RYTELO as a preferred second-line treatment option following prior therapy for lower-risk MDS and significant transfusion burden. We expect the prospective portion to provide additional insights, which we look forward to sharing at a future scientific meeting. Beyond our efforts in lower-risk MDS, additional presentations at ASCO and EHA highlighted progress across our myelofibrosis program, including an updated overall survival analysis from the phase II IMbark trial compared with real-world data.
Joseph Eid: The data also showed a trend toward optimal management of cytopenias and improved responses when RYTELO was used within the first three lines of therapy. Real-world evidence is an important complement to clinical trial data, helping us better understand how therapies perform in routine clinical practice. These findings add to the growing body of evidence for supporting the use of RYTELO as a preferred second-line treatment option following prior therapy for lower-risk MDS and significant transfusion burden. We expect the prospective portion to provide additional insights, which we look forward to sharing at a future scientific meeting. Beyond our efforts in lower-risk MDS, additional presentations at ASCO and EHA highlighted progress across our myelofibrosis program, including an updated overall survival analysis from the phase II IMbark trial compared with real-world data.
Speaker #2: Real-world evidence is an important complement to clinical trial data, helping us better understand how therapies perform in routine clinical practice. These findings add to the growing body of evidence for supporting the use of Rytello as a preferred second-line treatment option following prior therapy for lower-risk MDS and significant transfusion burden.
Speaker #2: We expect the prospective portion to provide additional insights which we look forward to sharing at a future scientific meeting. Beyond our efforts in lower-risk MDS, additional presentations at ASCO and EHA highlighted progress across our myelofibrosis program, including an updated overall survival analysis from the Phase II EMBARQ trial compared with real-world data.
Speaker #2: These findings, together with the totality of evidence generated across our clinical program, continue to support the potential of Hematostat in myelofibrosis and reinforce our confidence in overall survival as the appropriate endpoint for our Phase III IMpactMF trial.
Joseph Eid: These findings, together with the totality of evidence generated across our clinical program, continue to support the potential of imetelstat in myelofibrosis and reinforce our confidence in overall survival as the appropriate endpoint for our phase III IMpactMF trial. It is critical to maintain ongoing dialogue with regulatory authorities when conducting registrational trials. As IMpactMF approaches the one-year anniversary of enrollment completion, we have proactively engaged with the regulatory authorities over H1 2026 to ensure the interim analysis can support registration if the DMC recommends unblinding the trial for positive efficacy. As such, we are evaluating a modification to the event threshold for the interim analysis to ensure an appropriate evaluation of imetelstat's benefit/risk profile while we remain blinded to the treatment assignment. At this time, our projected timelines remain unchanged.
Joseph Eid: These findings, together with the totality of evidence generated across our clinical program, continue to support the potential of imetelstat in myelofibrosis and reinforce our confidence in overall survival as the appropriate endpoint for our phase III IMpactMF trial. It is critical to maintain ongoing dialogue with regulatory authorities when conducting registrational trials. As IMpactMF approaches the one-year anniversary of enrollment completion, we have proactively engaged with the regulatory authorities over H1 2026 to ensure the interim analysis can support registration if the DMC recommends unblinding the trial for positive efficacy. As such, we are evaluating a modification to the event threshold for the interim analysis to ensure an appropriate evaluation of imetelstat's benefit/risk profile while we remain blinded to the treatment assignment. At this time, our projected timelines remain unchanged.
Speaker #2: It is critical to maintain ongoing dialogue with regulatory authorities when conducting registrational trials. And as impact MF approaches the one-year anniversary of enrollment completion, we have proactively engaged with the regulatory authorities over the first half of 2026 to ensure the interim analysis can support registration if the DMC recommends unblinding the trial for positive efficacy.
Speaker #2: As such, we are evaluating a modification to the event threshold for the interim analysis to ensure an appropriate evaluation of hematostat benefit-risk profile while we remain blinded to the treatment assignment.
Speaker #2: At this time, our projected timelines remain unchanged, our base case remains progression to the final overall survival analysis in the second half of 2028, while an earlier positive outcome at the interim analysis would represent an upside scenario.
Joseph Eid: Our base case remains progression to the final overall survival analysis in H2 2028, while an earlier positive outcome at the interim analysis would represent an upside scenario. We will communicate any changes to these projections as appropriate. As a final note, the upcoming fall congress season, including SOHO and ASH, will provide additional opportunities to share data, engage with the hematology community, and continue building on the scientific momentum we've established this year. I'll now hand it over to Michelle to walk through financials.
Joseph Eid: Our base case remains progression to the final overall survival analysis in H2 2028, while an earlier positive outcome at the interim analysis would represent an upside scenario. We will communicate any changes to these projections as appropriate. As a final note, the upcoming fall congress season, including SOHO and ASH, will provide additional opportunities to share data, engage with the hematology community, and continue building on the scientific momentum we've established this year. I'll now hand it over to Michelle to walk through financials.
Speaker #2: We will communicate any changes to these projections as appropriate. As a final note, the upcoming full congress season including Soho and ASH will provide additional opportunities to share data, engage with the hematology community, and continue building on the scientific momentum we've established this year.
Speaker #2: I'll now hand it over to Michelle to walk through financials.
Speaker #3: Thank you, Joe. And good morning, everyone. For more detailed results from the second quarter, please refer to the press release we issued this morning, which is available on our website.
Michelle Robertson: Thank you, Joe, and good morning, everyone. For more detailed results from Q2, please refer to the press release we issued this morning, which is available on our website. Our H1 financial results, including 24% net revenue growth compared to the same period in 2025, along with a 4% decrease in total operating expenses compared to the same period in 2025, underscore the progress we are making on our operational execution while maintaining financial discipline. We are in a strong financial position and have the resources to deliver on our 2026 financial guidance while advancing the strategic priorities that will drive durable value creation for both patients and our shareholders.
Michelle Robertson: Thank you, Joe, and good morning, everyone. For more detailed results from Q2, please refer to the press release we issued this morning, which is available on our website. Our H1 financial results, including 24% net revenue growth compared to the same period in 2025, along with a 4% decrease in total operating expenses compared to the same period in 2025, underscore the progress we are making on our operational execution while maintaining financial discipline. We are in a strong financial position and have the resources to deliver on our 2026 financial guidance while advancing the strategic priorities that will drive durable value creation for both patients and our shareholders.
Speaker #3: Our first half financial results including 24% net revenue growth compared to the same period in 2025, along with a 4% decrease in total operating expenses, compared to the same period in 2025, underscore the progress we are making on our operational execution while maintaining financial discipline.
Speaker #3: We are in a strong financial position and have the resources to deliver on our 2026 financial guidance while advancing the strategic priorities that will drive durable value creation for both patients and our shareholders.
Speaker #3: In the second quarter, total net revenue for the three months ended June 30, 2026, was $57.5 million, compared to $49 million in Q2 2025.
Michelle Robertson: In Q2, total net revenue for the three months ending 30 June 2026 was $57.5 million, compared to $49 million in Q2 2025. Gross to net deductions increased to 20.7% for the three months ending 30 June 2026, compared to 15.3% for the same period in 2025. For the remainder of 2026, we continue to expect gross to net to be in the low to mid-20s. Research and development expenses for the three months ending 30 June 2026 were $22 million, compared to $21.7 million in expenses for the same period in 2025. The increase in research and development expenses was a result of investments in CMC and was partially offset by lower headcount costs from the workforce reduction in December 2025.
Michelle Robertson: In Q2, total net revenue for the three months ending 30 June 2026 was $57.5 million, compared to $49 million in Q2 2025. Gross to net deductions increased to 20.7% for the three months ending 30 June 2026, compared to 15.3% for the same period in 2025. For the remainder of 2026, we continue to expect gross to net to be in the low to mid-20s. Research and development expenses for the three months ending 30 June 2026 were $22 million, compared to $21.7 million in expenses for the same period in 2025. The increase in research and development expenses was a result of investments in CMC and was partially offset by lower headcount costs from the workforce reduction in December 2025.
Speaker #3: Gross-to-net deductions increased to 20.7% for the three months ended June 30, 2026, compared to 15.3% for the same period in 2025. For the remainder of 2026, we continue to expect gross-to-net to be in the low to mid-20s.
Speaker #3: Research and development expenses for the three months ended June 30th, 2026, were $22 million compared to $21.7 million in expenses for the same period in 2025.
Speaker #3: The increase in research and development expenses was a result of investments in CMC and was partially offset by lower headcount costs from the workforce reduction in December of 2025.
Speaker #3: For 2026, we expect continued investment in CMC and in our clinical development programs with lower employee costs driven by the decrease in headcount as a result of the workforce reduction in 2025.
Michelle Robertson: For 2026, we expect continued investment in CMC and in our clinical development programs with lower employee costs driven by the decrease in headcount as a result of the workforce reduction in 2025. Selling, general, and administrative expenses for the three months ending 30 June 2026 were $38.9 million, compared to $38.6 million for the same period in 2025. This change was primarily due to higher marketing expenses, partially offset by lower general and administrative personnel-related expenses as a result of the workforce reduction in December 2025. For 2026, we expect continued investment in our RYTELO commercialization strategy and flat G&A spend. Total operating expenses, excluding cost of goods sold for the three months ending 30 June 2026, were $60.7 million, compared to $60.3 million for the same period in 2025.
Michelle Robertson: For 2026, we expect continued investment in CMC and in our clinical development programs with lower employee costs driven by the decrease in headcount as a result of the workforce reduction in 2025. Selling, general, and administrative expenses for the three months ending 30 June 2026 were $38.9 million, compared to $38.6 million for the same period in 2025. This change was primarily due to higher marketing expenses, partially offset by lower general and administrative personnel-related expenses as a result of the workforce reduction in December 2025. For 2026, we expect continued investment in our RYTELO commercialization strategy and flat G&A spend. Total operating expenses, excluding cost of goods sold for the three months ending 30 June 2026, were $60.7 million, compared to $60.3 million for the same period in 2025.
Speaker #3: Selling, general, and administrative expenses for the three months ended June 30, 2026, were $38.9 million, compared to $38.6 million for the same period in 2025.
Speaker #3: This change was primarily due to higher marketing expenses partially offset by lower general and administrative personnel-related expenses as a result of the workforce reduction in December, 2025.
Speaker #3: For 2026, we expect continued investment in our Rytello commercialization strategy and flat GNA spend. Total operating expenses excluding cost of goods sold for the three months ended June 30th, 2026, were $60.7 million, compared to $60.3 million for the same period in 2025.
Speaker #3: Continued investments in commercial strategy and CMC were partially offset by lower headcount costs from the workforce reduction in December 2025. As of June 30, 2026, we had approximately $327 million in cash, cash equivalents, restricted cash, and marketable securities, compared to $341 million as of March 31, 2026.
Michelle Robertson: Continued investments in commercial strategy and CMC were partially offset by lower headcount costs from the workforce reduction in December 2025. As of 30 June 2026, we had approximately $327 million in cash equivalents, restricted cash, and marketable securities, compared to $341 million as of 31 March 2026. We are committed to maintaining our financial discipline and are well-positioned to fund growth from our current operations. Based on our solid performance and execution to date, we expect to come in at the mid to high end of our 2026 RYTELO net revenue guidance of $220 million to $240 million, reflecting consistent quarter-over-quarter net revenue growth throughout the year. Our total operating expense guidance of $230 million to $240 million reflects investment to accelerate RYTELO growth while maintaining operating expense discipline. We are well capitalized and on track to deliver on our strategic and financial priorities for the year.
Michelle Robertson: Continued investments in commercial strategy and CMC were partially offset by lower headcount costs from the workforce reduction in December 2025. As of 30 June 2026, we had approximately $327 million in cash equivalents, restricted cash, and marketable securities, compared to $341 million as of 31 March 2026. We are committed to maintaining our financial discipline and are well-positioned to fund growth from our current operations. Based on our solid performance and execution to date, we expect to come in at the mid to high end of our 2026 RYTELO net revenue guidance of $220 million to $240 million, reflecting consistent quarter-over-quarter net revenue growth throughout the year. Our total operating expense guidance of $230 million to $240 million reflects investment to accelerate RYTELO growth while maintaining operating expense discipline. We are well capitalized and on track to deliver on our strategic and financial priorities for the year.
Speaker #3: We are committed to maintaining our financial discipline and our well-positioned to fund growth from our current operations. Based on our solid performance and execution to date, we expect to come in at the mid to high end of our 2026 Rytello net revenue guidance of $220 million to $240 million, reflecting consistent quarter-over-quarter net revenue growth throughout the year.
Speaker #3: Our total operating expense guidance of $230 million to $240 million reflects investment to accelerate Rytelo growth while maintaining operating expense discipline. We are well capitalized and on track to deliver on our strategic and financial priorities for the year.
Speaker #3: With that, I'll turn the call back to Harout for closing remarks.
Michelle Robertson: With that, I'll turn the call back to Harout for closing remarks.
Michelle Robertson: With that, I'll turn the call back to Harout for closing remarks.
Speaker #2: Thanks, Michelle. As you've heard today, we've made meaningful progress through the first half of the year in advancing the strategy we outlined at the beginning of 2026.
Harout Semerjian: Thanks, Michelle. As you've heard today, we've made meaningful progress through the H1 of the year in advancing the strategy we outlined at the beginning of 2026. With a patient-focused and performance-driven Geron team, we are poised to deliver strong commercial execution, continued scientific engagement, and disciplined financial management. We're entering the H2 of 2026 with confidence in our strategy, our team, and the opportunities ahead. The focus is on expanding RYTELO's reach to more eligible patients in the US, expanding access to RYTELO in other geographies, advancing our phase III IMpactMF program, and evaluating opportunistic innovation that supports our long-term vision of building Geron into a leading hematology company. Operator, we're now ready to start the Q&A session.
Harout Semerjian: Thanks, Michelle. As you've heard today, we've made meaningful progress through the H1 of the year in advancing the strategy we outlined at the beginning of 2026. With a patient-focused and performance-driven Geron team, we are poised to deliver strong commercial execution, continued scientific engagement, and disciplined financial management. We're entering the H2 of 2026 with confidence in our strategy, our team, and the opportunities ahead. The focus is on expanding RYTELO's reach to more eligible patients in the US, expanding access to RYTELO in other geographies, advancing our phase III IMpactMF program, and evaluating opportunistic innovation that supports our long-term vision of building Geron into a leading hematology company. Operator, we're now ready to start the Q&A session.
Speaker #2: With a patient-focused and performance-driven Geron team, we are poised to deliver strong commercial execution, continued scientific engagement, and disciplined financial management. We're entering the second half of 2026 with confidence in our strategy, our team, and the opportunities ahead.
Speaker #2: The focus is on expanding Rytello's reach to more eligible patients in the US, expanding access to Rytello in other geographies, advancing our phase three impact MF program, and evaluating opportunistic innovation that supports our long-term vision of building GERON into a leading hematology company.
Speaker #2: Operator, we're now ready to start the Q&A session.
Speaker #1: Thank you. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again.
Operator: Thank you. As a reminder, to ask a question, please press *11 on your telephone and wait for your name to be announced. To withdraw your question, please press *11 again. Please stand by while we compile the Q&A roster. Our first question comes from Tara Bancroft of TD Cowen. Your line is open.
Operator: Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from Tara Bancroft of TD Cowen. Your line is open.
Speaker #1: Please stand by while we compile the Q&A roster. And our first question comes from Tara Bancroft of TD Callan. Your line is open.
Speaker #4: Hi, good morning. It's a great quarter. Really happy to see it. So I guess, you know, my question is, is going forward, you know, looking back on last year, it looked like seasonality.
Tara Bancroft: Hi. Good morning. It's a great quarter. Really happy to see it. I guess my question is, going forward, looking back on last year, it looked like seasonality. It did coincide with some major changes that you guys had at the company that you mentioned. I'm curious if you have any thoughts on how seasonality may impact the rest of this year, but potentially be offset by these efforts that you've got into inflecting in H2. Thanks so much.
Tara Bancroft: Hi. Good morning. It's a great quarter. Really happy to see it. I guess my question is, going forward, looking back on last year, it looked like seasonality. It did coincide with some major changes that you guys had at the company that you mentioned. I'm curious if you have any thoughts on how seasonality may impact the rest of this year, but potentially be offset by these efforts that you've got into inflecting in H2. Thanks so much.
Speaker #4: It did coincide with some major changes that you guys had at the company that you mentioned. So I'm curious if you have any thoughts on how seasonality may impact the rest of this year, but potentially be offset by these efforts that you've got into inflecting in the back half of the year.
Speaker #4: Thanks so much.
Speaker #3: Thank you, Tara. And good to hear from you. Yeah, we are very excited about this quarter, obviously. 57.5 million of net revenue sales, 17% gross year-over-year, 11% gross quarter-over-quarter, is something that, you know, as a team, we're very happy about.
Harout Semerjian: Thank you, Tara, and good to hear from you. We are very excited about this quarter, obviously. $57.5 million of net revenue sales, 17% growth year over year, 11% growth quarter over quarter is something that, as a team, we're very happy about. Of course, seasonality and other things have played a role, we really don't see that. Our finance teams, the commercial teams have really been very disciplined in terms of how we can anticipate some of these things. Maybe, Michelle, if you want to tackle some of that question, that would be great.
Harout Semerjian: Thank you, Tara, and good to hear from you. We are very excited about this quarter, obviously. $57.5 million of net revenue sales, 17% growth year over year, 11% growth quarter over quarter is something that, as a team, we're very happy about. Of course, seasonality and other things have played a role, we really don't see that. Our finance teams, the commercial teams have really been very disciplined in terms of how we can anticipate some of these things. Maybe, Michelle, if you want to tackle some of that question, that would be great.
Speaker #3: Of course, seasonality and other things have played a role, but we really don't see that. You know, our finance teams, the commercial teams have been very disciplined in terms of how we can anticipate some of these things, but maybe Michelle, if you want to tackle some of that question, that would be great.
Speaker #4: Yeah. I mean, Tara, we continue to manage our inventory within our range of two to four weeks. And as I've guided that, we're very comfortable with a gross to net projection and low to mid-20s.
Michelle Robertson: Tara, we continue to manage our inventory within our range of two to four weeks. As I've guided that we're very comfortable with a gross to net projection in low to mid-20s. We don't expect any significant spikes or decreases in H2. As Harout mentioned, we're looking for consistent growth quarter over quarter, we expect to be on the higher end of our revenue guidance.
Michelle Robertson: Tara, we continue to manage our inventory within our range of two to four weeks. As I've guided that we're very comfortable with a gross to net projection in low to mid-20s. We don't expect any significant spikes or decreases in H2. As Harout mentioned, we're looking for consistent growth quarter over quarter, we expect to be on the higher end of our revenue guidance.
Speaker #4: So we don't expect any significant spikes or decreases in the back half of the year, as Harout mentioned. We're looking for consistent gross quarter-over-quarter.
Speaker #4: And we expect to be on the higher end of our revenue guidance. Wonderful. Okay. Thank you guys.
Tara Bancroft: Wonderful. Okay. Thank you, guys.
Tara Bancroft: Wonderful. Okay. Thank you, guys.
Speaker #3: Thank you.
Harout Semerjian: Thank you.
Harout Semerjian: Thank you.
Speaker #1: Thank you. And our next question comes from Emily Bodner of HC Wainwright. Your line is open.
Operator: Thank you. Our next question comes from Emily Bodnar of H.C. Wainwright. Your line is open.
Operator: Thank you. Our next question comes from Emily Bodnar of H.C. Wainwright. Your line is open.
Speaker #5: Hi, good morning. Thanks for taking the questions and congrats on the quarter as well. Maybe as you're kind of growing your ordering accounts for Rytello, are you seeing increased reordering from existing accounts, or is gross kind of mainly coming from the new accounts?
Emily Bodnar: Hi, good morning. Thanks for taking the questions and congrats on the quarter as well. Maybe as you're kind of growing your ordering accounts for RYTELO, are you seeing increased reordering from existing accounts, or is growth kind of mainly coming from the new accounts? Secondly, as you're kind of seeing more of an increase into first-line, second-line patients compared to third-line patients, are you also seeing an increase in persistence and time on therapy with that as well? Thank you.
Emily Bodnar: Hi, good morning. Thanks for taking the questions and congrats on the quarter as well. Maybe as you're kind of growing your ordering accounts for RYTELO, are you seeing increased reordering from existing accounts, or is growth kind of mainly coming from the new accounts? Secondly, as you're kind of seeing more of an increase into first-line, second-line patients compared to third-line patients, are you also seeing an increase in persistence and time on therapy with that as well? Thank you.
Speaker #5: And then secondly, as you're kind of seeing more of an increase into first-line, second-line patients compared to third-line patients, are you also seeing an increase in persistence and time-out therapy with that as well?
Speaker #5: Thank you.
Speaker #3: Yeah. Thank you, Emily. I'll open it up, and then I'll hand it to Nawabi for additional color. Our growth is really coming from both.
Harout Semerjian: Yeah. Thank you, Emily. I'll open it up and then I'll hand it to Nawawi for additional color. Our growth is really coming from both. One of the things which we're quite happy about is our growth is now predominantly driven by the community accounts, which is really where the further growth will happen and the further penetration would happen. Nawawi, do you want to give some additional color on that?
Harout Semerjian: Yeah. Thank you, Emily. I'll open it up and then I'll hand it to ElNawawi for additional color. Our growth is really coming from both. One of the things which we're quite happy about is our growth is now predominantly driven by the community accounts, which is really where the further growth will happen and the further penetration would happen. ElNawawi, do you want to give some additional color on that?
Speaker #3: One of the things which we're quite happy about is our growth is now predominantly driven by the community accounts, which is really where, you know, the further growth will happen.
Speaker #3: And the further penetration would happen. But Nawabi, do you want to give some additional color on that?
Speaker #6: Yeah, thank you, Emily, for the question. The growth is coming from both, as Harout mentioned. We do expect, as our strategy continues to be executed successfully, that the breadth will be playing a smaller component in the second half of the year, and the depth is becoming a more focused metric that we are focused on.
Ahmed ElNawawi: Yeah. Thank you, Emily, for the question. The growth is coming from both, as Harout mentioned. We do expect as our strategy continues to be executed successfully, that the breadth will be playing a smaller component in the H2 of the year, and the depth is becoming a more focused metric that we are focused on. It was very encouraging to see that the community accounts, especially the high-tier community accounts, are responding well to our messages, and that is playing a bigger role in our book of business. Duration of therapy is something that we don't have a good metric to track. We don't see it either going up or down because we don't really have a decent denominator, if you will, that allows us to measure that.
Ahmed ElNawawi: Yeah. Thank you, Emily, for the question. The growth is coming from both, as Harout mentioned. We do expect as our strategy continues to be executed successfully, that the breadth will be playing a smaller component in the H2 of the year, and the depth is becoming a more focused metric that we are focused on. It was very encouraging to see that the community accounts, especially the high-tier community accounts, are responding well to our messages, and that is playing a bigger role in our book of business. Duration of therapy is something that we don't have a good metric to track. We don't see it either going up or down because we don't really have a decent denominator, if you will, that allows us to measure that.
Speaker #6: And it was very encouraging to see that the community accounts, especially the high-tier community accounts, are responding well to our messages, and that is playing a bigger role in our book of business.
Speaker #6: Duration of therapy is something that we don't have a good metric to track. We don't see either going up or down because we don't really have a decent denominator, if you will, that allows us to measure that.
Speaker #3: Thank you, Nawabi.
Harout Semerjian: Thank you, Nawawi.
Harout Semerjian: Thank you,ElNawawi.
Speaker #5: Thank you.
Emily Bodnar: Thank you.
Emily Bodnar: Thank you.
Speaker #1: Thank you. And as a reminder, if you have a question, please press star one-one. And our next question comes from Stephen Willey of Stifel.
Operator: Thank you. As a reminder, if you have a question, please press * one one. Our next question comes from Stephen Willey of Stifel. Your line is open.
Operator: Thank you. As a reminder, if you have a question, please press star one one. Our next question comes from Stephen Willey of Stifel. Your line is open.
Speaker #1: Your line is open.
Speaker #7: Yeah, good morning. Thanks for taking the questions and congrats on the progress. So it sounds like you are in discussion with FDA around potentially modifying the event threshold for the interim.
Stephen Willey: Yeah, good morning. Thanks for taking the questions and congrats on the progress. It sounds like you are in discussion with FDA around potentially modifying the event threshold for the interim. Just curious if there's been any contemplation of altering the threshold for the final OS analysis as well. Thanks.
Stephen Willey: Yeah, good morning. Thanks for taking the questions and congrats on the progress. It sounds like you are in discussion with FDA around potentially modifying the event threshold for the interim. Just curious if there's been any contemplation of altering the threshold for the final OS analysis as well. Thanks.
Speaker #7: Just curious if there's been any contemplation of altering the threshold for the final OS analysis as well. Thanks.
Speaker #3: Thanks, Steve, and thanks for the question. Maybe a couple of words from me before turning it to Joe. You know, we've always maintained that—from our planning purposes—we think that these trials, which have overall survival as the primary endpoint, need time to mature.
Harout Semerjian: Thanks, Steve. Thanks for the question. Maybe a couple of words from me before turning it to Joe. We've always maintained that from our planning purposes, we think that these trials, which are overall survival primary endpoint, need time to mature. That's why our base planning is always for it to go the full length, with the caveat that there is an interim analysis that is built into the trial design, which is very appropriate in our opinion. We want to make sure that those interims are very well and consistent with the regulators, given that these trials have taken many years to be fully enrolled. That's why we are having those conversations on the interim.
Harout Semerjian: Thanks, Steve. Thanks for the question. Maybe a couple of words from me before turning it to Joe. We've always maintained that from our planning purposes, we think that these trials, which are overall survival primary endpoint, need time to mature. That's why our base planning is always for it to go the full length, with the caveat that there is an interim analysis that is built into the trial design, which is very appropriate in our opinion. We want to make sure that those interims are very well and consistent with the regulators, given that these trials have taken many years to be fully enrolled. That's why we are having those conversations on the interim.
Speaker #3: That's why our base planning is always for it to go the full length, with the caveat that there is an interim analysis that is built into the trial design, which is very appropriate in our opinion. We want to make sure that those interims are very well aligned and consistent with the regulators, given that these trials have taken many, many years to be fully enrolled.
Speaker #3: So that's why we are having those conversations on the interim. It doesn't change that design of the trial, but that's one where you know, we're engaging with the regulators at this point, predominantly around the interim rather than the, you know, full design of the trial.
Harout Semerjian: It doesn't change the design of the trial, that's one where we're engaging with the regulators at this point, predominantly around the interim rather than the full design of the trial. We do believe the trial is a very appropriate trial for a patient population and for what we're trying to show over here. Joe, anything else you want to add?
Harout Semerjian: It doesn't change the design of the trial, that's one where we're engaging with the regulators at this point, predominantly around the interim rather than the full design of the trial. We do believe the trial is a very appropriate trial for a patient population and for what we're trying to show over here. Joe, anything else you want to add?
Speaker #3: We do believe the trial is a very appropriate trial for a patient population and for what we're trying to show over here. Joe, anything else you want to add?
Speaker #2: Yeah. I mean, we're making sure that there's alignment on the interim analysis, whether it's the threshold, you know, given that the trial started in the early 2020s and FDA changes standard of care changes.
Joseph Eid: Yeah. We are making sure that there is alignment on the interim analysis, whether it is the threshold, given that the trial started in the early 2020s and FDA changes, standard of care changes, so that is appropriate. As far as the final analysis, the OS primary endpoint as well as the timing are not changing.
Joseph Eid: Yeah. We are making sure that there is alignment on the interim analysis, whether it is the threshold, given that the trial started in the early 2020s and FDA changes, standard of care changes, so that is appropriate. As far as the final analysis, the OS primary endpoint as well as the timing are not changing.
Speaker #2: So that's, you know, appropriate as far as the final analysis, you know, the OS primary endpoint as well as the timing are not changing.
Speaker #7: All right. Thanks for taking the question.
Stephen Willey: All right. Thanks for taking the question.
Stephen Willey: All right. Thanks for taking the question.
Speaker #1: Thank you. And as a reminder, if you do have a question, please press star 11. One moment for our next question. And our next question comes from Gil Blum of Needham.
Operator: Thank you. As a reminder, if you do have a question, please press * one one. One moment for our next question. Our next question comes from Gil Blum of Needham. Your line is open.
Operator: Thank you. As a reminder, if you do have a question, please press star one one. One moment for our next question. Our next question comes from Gil Blum of Needham. Your line is open.
Speaker #1: Your line is open.
Speaker #8: Hey, guys. Congrats on the quarter. This is Jonathan on for Gil. Just a quick question here around the EU commercial strategy. I know you guys mentioned that you guys are thinking about pricing dynamics, obviously, as you think about a potential EU strategy.
[Analyst] (Needham): Hey, guys. Congrats on the quarter. This is Jonathan on for Gil. Just a quick question here around the EU commercial strategy. I know you guys mentioned that you guys are thinking about pricing dynamics, obviously, as you think about a potential EU strategy. I just wanted to clarify that, with MFN concerns, this would mean countries that don't have visible net prices. Also, just wanted to see if potential paths forward include potential partnerships. Thanks.
[Analyst] (Needham): Hey, guys. Congrats on the quarter. This is Jonathan on for Gil. Just a quick question here around the EU commercial strategy. I know you guys mentioned that you guys are thinking about pricing dynamics, obviously, as you think about a potential EU strategy. I just wanted to clarify that, with MFN concerns, this would mean countries that don't have visible net prices. Also, just wanted to see if potential paths forward include potential partnerships. Thanks.
Speaker #8: I just wanted to clarify that with MFN concerns, this would mean countries that don't have visible net prices, also just wanted to see if potential paths forward continue or, sorry, potential paths forward include potential partnerships.
Speaker #8: Thanks.
Speaker #3: Thank you, Jonathan, for the question, for the two questions. Yeah, look, I mean, our vision is to have Rytello help as many patients as possible in the US and XUS.
Harout Semerjian: Thank you, Jonathan, for the two questions. Look, our vision is to have RYTELO help as many patients as possible in the US and ex-US. As we have mentioned before, we believe there is as much opportunity in terms of patient numbers in Europe as there is in the US, and that is in the thousands. That is something which we want to actively pursue and see what are the optimal ways of helping those patients. As you know, predominantly, our trials have actually been conducted in Europe, so there is a lot of advocacy, a lot of medical experts who have hands-on experience in Europe, and we're engaging with them. We're engaging with the payers as well. We understand the MFN dynamic, and that's something we're monitoring very closely. The MFN itself is actually evolving as well.
Harout Semerjian: Thank you, Jonathan, for the two questions. Look, our vision is to have RYTELO help as many patients as possible in the US and ex-US. As we have mentioned before, we believe there is as much opportunity in terms of patient numbers in Europe as there is in the US, and that is in the thousands. That is something which we want to actively pursue and see what are the optimal ways of helping those patients. As you know, predominantly, our trials have actually been conducted in Europe, so there is a lot of advocacy, a lot of medical experts who have hands-on experience in Europe, and we're engaging with them. We're engaging with the payers as well. We understand the MFN dynamic, and that's something we're monitoring very closely. The MFN itself is actually evolving as well.
Speaker #3: As we have mentioned before, we believe there's as much opportunity in terms of patient numbers in Europe as there is in the US. And that is in the thousands.
Speaker #3: So that is something which we want to actively pursue and see what are the optimal ways of helping those patients. As you know, predominantly our trials have actually been conducted in Europe.
Speaker #3: So, there is a lot of advocacy, a lot of medical experts who have hands-on experience, and we're engaging with them. We're engaging with the payers as well.
Speaker #3: We understand the MFN dynamic, and that's something we're monitoring it very closely. The MFN itself is actually, you know, evolving as well. We're waiting for more updates on the Golden Guard models and once we have those, we'll have a, you know, more further look into that.
Harout Semerjian: We're waiting for more updates on the gold standard models, and once we have those, we'll have a further look into that. The fact remains that there are thousands of patients who can really help, and that's why we've said we want to actively pursue a strategy in Europe. It can include or exclude partnership conversations as well, Jonathan. I think in the world of MFN, everybody's learning how to launch therapies and bring it to more patients outside. We believe that this is one where, given that the rules are evolving, we believe that we can have those conversations and come up with an update to the market back before end of the year, as we previously mentioned, on what would be an optimized strategy ex-US, in particular Europe, in particular some of the major countries like Germany and France. Does that answer your question?
Harout Semerjian: We're waiting for more updates on the gold standard models, and once we have those, we'll have a further look into that. The fact remains that there are thousands of patients who can really help, and that's why we've said we want to actively pursue a strategy in Europe. It can include or exclude partnership conversations as well, Jonathan. I think in the world of MFN, everybody's learning how to launch therapies and bring it to more patients outside. We believe that this is one where, given that the rules are evolving, we believe that we can have those conversations and come up with an update to the market back before end of the year, as we previously mentioned, on what would be an optimized strategy ex-US, in particular Europe, in particular some of the major countries like Germany and France. Does that answer your question?
Speaker #3: But the fact remains that there are thousands of patients who can really help, and that's why we've said we want to, you know, actively pursue a strategy in Europe.
Speaker #3: And it can include or exclude partnership conversations as well, Jonathan. I think in the world of MFN, everybody's learning how to, you know, launch therapies and bring it to more patients outside.
Speaker #3: So we believe that this is one where given that the rules are evolving, we believe that we can have those conversations and come up with an update to the market back before end of the year as we've previously mentioned.
Speaker #3: On what would be an optimized strategy XUS in particular Europe, in particular some of the major countries like Germany and France. Does that answer your question?
Speaker #8: Yeah, appreciate it. Thank you.
[Analyst] (Needham): Appreciate it. Thank you.
[Analyst] (Needham): Appreciate it. Thank you.
Speaker #3: Thank you.
Harout Semerjian: Thank you.
Harout Semerjian: Thank you.
Speaker #1: Thank you. I show no further questions at this time. I'd like to turn it back to Harut Samerjian for closing remarks.
Operator: Thank you. I show no further questions at this time. I'd like to turn it back to Harout Semerjian for closing remarks.
Operator: Thank you. I show no further questions at this time. I'd like to turn it back to Harout Semerjian for closing remarks.
Speaker #3: Thank you, everyone, for joining our call today. We look forward to updating you on our progress in the next quarters. And I'm sure we're going to have a lot of one-on-ones as well.
Harout Semerjian: Thank you everyone for joining our call today. We look forward to updating you on our progress in the next quarters, and I'm sure we're going to have a lot of one-on-ones as well. Looking forward to that. Thank you.
Harout Semerjian: Thank you everyone for joining our call today. We look forward to updating you on our progress in the next quarters, and I'm sure we're going to have a lot of one-on-ones as well. Looking forward to that. Thank you.
Speaker #3: So looking forward to that. Thank you.
Operator: This concludes today's conference call. Thank you for participating, and you may now disconnect.
Operator: This concludes today's conference call. Thank you for participating, and you may now disconnect.