Q1 2026 Rigel Pharmaceuticals Inc Earnings Call

May 5, 2026

Operator 2: Greetings, welcome to Rigel Pharmaceuticals' financial conference call for Q1 2026. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce our speaker, Raymond J. Furey, Rigel's Executive Vice President, General Counsel, and Corporate Secretary. Thank you. Mr. Furey, you may begin.

Operator: Greetings, welcome to Rigel Pharmaceuticals' Financial Conference Call for Q1 2026. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce our speaker, Ray Furey, Rigel's Executive Vice President, General Counsel, and Corporate Secretary. Thank you. Mr. Furey, you may begin.

Speaker #1: A brief question-and-answer session will follow the formal presentation. If anyone should require operative assistance during the conference, please press star zero on your telephone keypad.

Speaker #1: As a reminder, this conference is being recorded. It is now my pleasure to introduce our speaker, Ray Furey, Rigel's executive vice president, general counsel, and corporate secretary.

Speaker #1: Thank you. Mr. Furey, you may begin.

Speaker #2: Welcome to our first quarter 2026 financial results and business update conference call. The financial press release for the first quarter 2026 was issued a short while ago and can be viewed along with the slides for this presentation from the news and events section of our investor relations site on rigel.com.

Raymond J. Furey: Welcome to our Q1 2026 Financial Results Business Update Conference Call. The financial press release for Q1 2026 was issued a short while ago and can be viewed along with the slides for this presentation in the News & Events section of our investor relations site on rigel.com. As a reminder, during today's call, we may make forward-looking statements regarding our financial outlook and our plans and timing for regulatory product development. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. A description of these risks can be found in our most recent annual report, Form 10-K, for the year ended 31 December 2025, on file with the SEC, and subsequent filings with the SEC, including the Q1 quarterly report on Form 10-Q with the SEC.

Ray Furey: Welcome to our Q1 2026 financial results business update conference call. The financial press release for Q1 2026 was issued a short while ago and can be viewed along with the slides for this presentation in the News & Events section of our Investor Relations site on rigel.com. As a reminder, during today's call, we may make forward-looking statements regarding our financial outlook and our plans and timing for regulatory product development. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. A description of these risks can be found in our most recent annual report, Form 10-K, for the year ended 31 December 2025, on file with the SEC, and subsequent filings with the SEC, including the Q1 quarterly report on Form 10-Q with the SEC.

Speaker #2: As a reminder, during today's call, we may make forward-looking statements regarding our financial outlook and our plans and timing for regulatory product development. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted.

Speaker #2: A description of these risks can be found on our most recent annual report, Form 10-K for the year ended December 31st, 2025, on file with the SEC, and subsequent filings with the SEC, including the Q1 quarterly report on Form 10-Q with the SEC.

Speaker #2: Any forward-looking statements are made only as of today's date, and we undertake no obligation to update these forward-looking statements to reflect subsequent events or circumstances.

Raymond J. Furey: Any forward-looking statements are made only as of today's date, and we undertake no obligation to update these forward-looking statements to reflect subsequent events or circumstances. At this time, I'd like to turn the call over to our President and Chief Executive Officer, Raul Rodriguez. Raul.

Ray Furey: Any forward-looking statements are made only as of today's date, and we undertake no obligation to update these forward-looking statements to reflect subsequent events or circumstances. At this time, I'd like to turn the call over to our President and Chief Executive Officer, Raul Rodriguez. Raul.

Speaker #2: At this time, I'd like to turn the call over to our president and chief executive officer, Raul Rodriguez. Raul?

Speaker #3: Thank you, Ray, and thank you for joining us today. Also joining me on the call today are Dave Santos, our chief commercial officer; Lisa Rojkjaer, our chief medical officer; and Dean Schorno, our chief financial officer.

Raul Rodriguez: Thank you, Ray. Thank you for joining us today. Also joining me on the call today are David Santos, our Chief Commercial Officer, Lisa Rojkjaer, our Chief Medical Officer, and Dean Schorno, our Chief Financial Officer. Beginning on slide 4, I will review our Q1 performance, outline Rigel's growth strategy, and highlight the key strategic initiatives that positions us for continued growth. Rigel is in a solid position with a growing product portfolio, a solid financial foundation, and an advancing clinical pipeline. In Q1 2026, we generated net product sales of just under $55 million, representing a 26% growth compared to Q1 2025. As expected, the Q1 was impacted by seasonal factors, including reimbursement dynamics, patterns we have seen historically both within our business and across our industry. Encouragingly, we observed improving demand in March.

Raul Rodriguez: Thank you, Ray. Thank you for joining us today. Also joining me on the call today are Dave Santos, our Chief Commercial Officer, Lisa Rojkjaer, our Chief Medical Officer, and Dean Schorno, our Chief Financial Officer. Beginning on slide four, I will review our Q1 performance, outline Rigel's growth strategy, and highlight the key strategic initiatives that positions us for continued growth. Rigel is in a solid position with a growing product portfolio, a solid financial foundation, and an advancing clinical pipeline. In Q1 2026, we generated net product sales of just under $55 million, representing a 26% growth compared to Q1 2025. As expected, the Q1 was impacted by seasonal factors, including reimbursement dynamics, patterns we have seen historically both within our business and across our industry. Encouragingly, we observed improving demand in March.

Speaker #3: Beginning on slide four, I will review our first quarter performance, outline Rigel's growth strategy, and highlight the key strategic initiatives that position us for continued growth.

Speaker #3: Rigel is in a solid position with a growing product portfolio, a solid financial foundation, and an advancing clinical pipeline. In the first quarter of 2026, we generated net product sales of just under $55 million.

Speaker #3: Representing a 26% growth compared to the first quarter of 2025. As expected, the first quarter was impacted by seasonal factors, including reimbursement dynamics. Patterns we have seen historically both within our business and across our industry.

Speaker #3: Encouragingly, we observed improving demand in March. Similar to prior years, we expect to return to sequential growth starting in the second quarter, driven by improving demand trends.

Raul Rodriguez: Similar to prior years, we expect to return to sequential growth starting in Q2, driven by improving demand trends. As a result, we are maintaining our 2026 revenue guidance for total revenues of $275 to 290 million, including net product sales of $255 to 265 million. We also remain on track to achieve net income profitability in 2026, and we will continue to update you on our progress throughout the year. We're also very encouraged by the continued progress of our R289 program in lower-risk MDS, with data expected by year-end. In parallel, we are actively evaluating late-stage in-license or acquisition opportunities that would support potential launches between 2026 and 2028. Now, let me turn to our transformational growth strategy.

Speaker #3: As a result, we are maintaining our 2026 revenue guidance for total revenues of $275 to $290 million. Including net product sales of $255 to $265 million.

Speaker #3: We also remain on track to achieve net income profitability in 2026, and we will continue to update you on our progress throughout the year.

Speaker #3: We're also very encouraged by the continued progress of our R289 program in lower-risk MDS, with data expected by year-end. In parallel, we are actively evaluating late-stage in-license or acquisition opportunities that would support potential launches between 2026 and 2028.

Speaker #3: Now, let me turn to our transformational growth strategy. This strategy is guided has guided Rigel's evolution and is built on four core strategic objectives.

Raul Rodriguez: This strategy has guided Rigel's evolution and is built on four core strategic objectives: continued commercial execution, pipeline expansion through in-licensing or acquisition of late-stage assets, advancing our clinical development pipeline, and maintaining financial discipline. These four pillars form the foundation of Rigel's growth strategy. Today, I will walk you through how we have successfully executed this strategy since 2020 to build the company we are today and how we plan to continue driving growth going forward. Moving to slide 5. Back in 2020, Rigel was a single-product company with a limited development pipeline and negative operating cash flows. Today, as you look at our progress through 2025 and towards 2030, we are fundamentally a different company. We now have 3 commercial products, TAVALISSE, REZLIDHIA, and GAVRETO, approved across 4 indications.

Raul Rodriguez: This strategy has guided Rigel's evolution and is built on four core strategic objectives: continued commercial execution, pipeline expansion through in-licensing or acquisition of late-stage assets, advancing our clinical development pipeline, and maintaining financial discipline. These four pillars form the foundation of Rigel's growth strategy. Today, I will walk you through how we have successfully executed this strategy since 2020 to build the company we are today and how we plan to continue driving growth going forward. Moving to slide five. Back in 2020, Rigel was a single-product company with a limited development pipeline and negative operating cash flows. Today, as you look at our progress through 2025 and towards 2030, we are fundamentally a different company. We now have three commercial products, TAVALISSE, REZLIDHIA, and GAVRETO, approved across four indications.

Speaker #3: Continued commercial execution, pipeline expansion through in-licensing or acquisition of late-stage assets, advancing our clinical development pipeline, and maintaining financial discipline. These four pillars form the foundation of Rigel's growth strategy.

Speaker #3: Today, I will walk you through how we have successfully executed this strategy since 2020 to build the company we are today and how we plan to continue driving growth going forward.

Speaker #3: Moving to slide five, back in 2020, Rigel was a single product company with a limited development pipeline and negative operating cash flows. Today, as you look at our progress through 2025 and towards 2030, we are fundamentally a different company.

Speaker #3: We now have three commercial products: Avelis, Resilia, and Gavreto, approved across four indications. R289 is advancing in lower-risk MDS, and this program has the potential to expand into large markets with significant unmet medical need.

Raul Rodriguez: R289 is advancing in lower-risk MDS, and this program has the potential to expand into large markets with significant unmet medical need. Importantly, we achieved profitability in Q3 2024, and through the end of 2025, we generated over $100 million in cash reflecting our financial discipline. We are operating from a position of financial strength, allowing us to fund our operations and continue advancing and expanding our pipeline. Moving to slide 6. Since emerging from the COVID pandemic, we have delivered strong net product sales growth, driven by solid commercial execution and successful portfolio expansion. We believe this is just the beginning. We see multiple opportunities for us to drive another phase of transformational revenue growth for Rigel.

Speaker #3: Importantly, we achieved profitability in the third quarter of 2024, and through the end of 2025, we generated over $100 million in cash, reflecting our financial discipline.

Speaker #3: We are operating from a position of financial strength, allowing us to fund our operations and continue advancing and expanding our pipeline. Moving to slide six, since emerging from the COVID pandemic, we have delivered strong net product sales growth driven by solid commercial execution and successful portfolio expansion.

Speaker #3: And we believe this is just the beginning. We see multiple opportunities for us to drive another phase of transformational revenue growth for Rigel. In addition to growth of our current products, we are also focusing on adding new assets through in-licensing or product acquisition, as well as advancing our internal pipeline, particularly R289 and lower-risk MDS, and other potential indications.

Raul Rodriguez: In addition to growth of our current products, we are also focusing on adding new assets through in-licensing or product acquisition, as well as advancing our internal pipeline, particularly R289 and lower-risk MDS and other potential indications. These programs potentially represent significant long-term opportunities that could expand our commercial portfolio in the 2030s and beyond, supporting sustained growth and long-term shareholder value. Before I hand the call over to Dave to review our commercial performance, let me briefly remind you of our approach to in-licensing and business development. On slide 8, you'll see that we're targeting differentiated assets in hematology, oncology, and related areas. You've seen us successfully integrate both REZLIDHIA and then GAVRETO into our portfolio in 2022 and 2024 respectively. Today, we are pursuing similar opportunities, potentially larger in scale, though, given Rigel's growth since those earlier transactions.

Speaker #3: These programs potentially represent significant long-term opportunities that could expand our commercial portfolio in the 2030s and beyond, supporting sustained growth and long-term shareholder value.

Speaker #3: Before I hand the call over to Dave to review our commercial performance, let me briefly remind you of our approach to in-licensing and business development.

Speaker #3: On slide eight, you'll see that we're targeting differentiated assets in hematology, oncology, and related areas. You've seen us successfully integrate both Resilia and then Gavreto into our portfolio in 2022 and 2024, respectively.

Speaker #3: Today, we are pursuing similar opportunities, potentially larger in scale, though, given Rigel's growth since those earlier transactions. We are focused on late-stage assets, with potential commercial launches in the next three years.

Raul Rodriguez: We are focused on late-stage assets with potential commercial launches in the next 3 years. By late stage, we mean assets that are NDA-ready for filing, or are already under review, or are already approved. Importantly, we prioritize opportunities where we can leverage our existing infrastructure to drive operational efficiencies, accelerate revenue contribution, and generate cash. With that, I'll turn the call over to Dave. Dave?

Speaker #3: By late stage, we mean assets that are NDA-ready for filing or are already under review or are already approved. Importantly, we prioritize opportunities where we can leverage our existing infrastructure to drive operational efficiencies, accelerate revenue contribution, and generate cash.

Speaker #3: With that, I'll turn the call over to Dave. Dave?

Speaker #4: Thank you, Raul. On slide 10, you'll see our three commercial products: Avelis, Gavreto, and Resilia. Moving to slide 11, we are pleased with the year-over-year growth in revenues in the first quarter of 2026, continuing our trend of growing each quarter sales over the previous year, as evidenced by this slide.

David Santos: Thank you, Raul. On slide 10, you'll see our three commercial products, TAVALISSE, GAVRETO, and REZLIDHIA. Moving to slide 11. We are pleased with the year-over-year growth in revenues in Q1 of 2026, continuing our trend of growing each quarter's sales over the previous year, as evidenced by this slide. In Q1 of 2026, we generated $54.9 million in US net product sales, an increase of $11.3 million over Q1 of 2025, representing a 26% increase year over year. Our Q1 net sales were impacted by typical Q1 reimbursement dynamics, such as resetting of deductibles, co-pays, and other access delays for Medicare patients with plan changes that took effect in January.

Dave Santos: Thank you, Raul. On slide 10, you'll see our three commercial products, TAVALISSE, GAVRETO, and REZLIDHIA. Moving to slide 11. We are pleased with the year-over-year growth in revenues in Q1 of 2026, continuing our trend of growing each quarter's sales over the previous year, as evidenced by this slide. In Q1 of 2026, we generated $54.9 million in US net product sales, an increase of $11.3 million over Q1 of 2025, representing a 26% increase year over year. Our Q1 net sales were impacted by typical Q1 reimbursement dynamics, such as resetting of deductibles, co-pays, and other access delays for Medicare patients with plan changes that took effect in January.

Speaker #4: In the first quarter of 2026, we generated $54.9 million in US net product sales. An increase of 11.3 million over Q1 of 2025, representing a 26% increase year over year.

Speaker #4: Our first quarter net sales were impacted by typical first-quarter reimbursement dynamics, such as resetting of deductibles, copays, and other access delays for Medicare patients with plan changes that took effect in January.

Speaker #4: Consistent with this pattern, our first quarter 2026 net product sales reflected the impact of these seasonal factors. Which primarily affected January and February volumes.

David Santos: Consistent with this pattern, our Q1 2026 net product sales reflected the impact of these seasonal factors, which primarily affected January and February volumes. We observed improving demand in March, which showed stronger volume across our product portfolio. Specifically on TAVALISSE, I am pleased to report another strong quarter in which we generated $37.3 million in net product sales, an increase of 31% compared to the Q1 2025. This growth was driven by both stronger demand and a favorable gross to net versus last year. As a reminder, in 2025, we experienced a one-time influx of patients due to the elimination of the coverage gap and improved affordability for Medicare patients. For GAVRETO, we delivered $9.6 million in net product sales, an increase of 7% compared to the Q1 2025.

Dave Santos: Consistent with this pattern, our Q1 2026 net product sales reflected the impact of these seasonal factors, which primarily affected January and February volumes. We observed improving demand in March, which showed stronger volume across our product portfolio. Specifically on TAVALISSE, I am pleased to report another strong quarter in which we generated $37.3 million in net product sales, an increase of 31% compared to the Q1 2025. This growth was driven by both stronger demand and a favorable gross to net versus last year. As a reminder, in 2025, we experienced a one-time influx of patients due to the elimination of the coverage gap and improved affordability for Medicare patients. For GAVRETO, we delivered $9.6 million in net product sales, an increase of 7% compared to the Q1 2025.

Speaker #4: We observed improving demand in March, which showed stronger volume across our product portfolio. Specifically, on Avelis, I'm pleased to report another strong quarter in which we generated $37.3 million in net product sales and increase of 31% compared to the first quarter of 2025.

Speaker #4: This growth was driven by both stronger demand and a favorable gross-to-net versus last year. As a reminder, in 2025, we experienced a one-time influx of patients due to the elimination of the coverage gap and improved affordability for Medicare patients.

Speaker #4: For Gavreto, we delivered $9.6 million in net product sales, an increase of 7% compared to the first quarter of 2025. Gavreto has become a stable, contributing product in our portfolio.

David Santos: Gavreto has become a stable, contributing product in our portfolio. For REZLIDHIA, we reported $8 million in net product sales, an increase of 31% compared to the prior year period. We saw continued building of breadth and depth in academic accounts and remain focused on growing use in the community. With new venetoclax-based therapy data showing superiority to intensive therapy in the frontline setting, we expect that REZLIDHIA's consistent efficacy in the post-venetoclax setting to become even more relevant and improve adoption in the community. Overall, we have begun 2026 with significant 26% growth versus Q1 of 2025. With our continued focus on TAVALISSE new patient starts and improved adoption of REZLIDHIA, particularly in the community, our commercial team looks forward to driving continued momentum for our products in 2026. My sincere thanks to the entire team for all their hard work.

Dave Santos: Gavreto has become a stable, contributing product in our portfolio. For REZLIDHIA, we reported $8 million in net product sales, an increase of 31% compared to the prior year period. We saw continued building of breadth and depth in academic accounts and remain focused on growing use in the community. With new venetoclax-based therapy data showing superiority to intensive therapy in the frontline setting, we expect that REZLIDHIA's consistent efficacy in the post-venetoclax setting to become even more relevant and improve adoption in the community. Overall, we have begun 2026 with significant 26% growth versus Q1 of 2025. With our continued focus on TAVALISSE new patient starts and improved adoption of REZLIDHIA, particularly in the community, our commercial team looks forward to driving continued momentum for our products in 2026. My sincere thanks to the entire team for all their hard work.

Speaker #4: And for Resilia, we reported $8 million in net product sales, an increase of 31% compared to the prior year period. We saw continued building of breadth and depth in academic accounts, and remain focused on growing use in the community.

Speaker #4: With new Venetoclax-based therapy data, showing superiority to intensive therapy in the frontline setting, we expect that Resilia's consistent efficacy in the post-Venetoclax setting to become even more relevant and improve adoption in the community.

Speaker #4: Overall, we have begun 2026 with significant 26% growth versus Q1 of 2025. With our continued focus on Avelis new patient starts and improved adoption of Resilia, particularly in the community, our commercial team looks forward to driving continued momentum for our products in 2026.

Speaker #4: My sincere thanks to the entire team, for all their hard work. Moving to slide 12, we generated $3.9 million in revenues from collaborations in the first quarter.

David Santos: Moving to slide 12, we generated $3.9 million in revenues from collaborations in Q1, driven by the availability of TAVALISSE in global markets. TAVALISSE is commercially available in Europe under the brand name TAVLESSE, in Japan and South Korea and Asia, and in Canada and Israel via our partners, Grifols, Kissei, and Medison Pharma. In addition, our partners continue to pursue regulatory approvals for TAVALISSE in new markets. We continue to work on expanding access to our products in markets outside of the US. For REZLIDHIA in 2024, we expanded our relationship with Kissei to include several countries in Asia for all potential indications, and we entered into an exclusive license agreement with Dr. Reddy's Laboratories for all potential indications throughout Dr. Reddy's Laboratories' territories. These partners are now in the process of advancing REZLIDHIA in preparation for future potential regulatory submissions.

Dave Santos: Moving to slide 12, we generated $3.9 million in revenues from collaborations in Q1, driven by the availability of TAVALISSE in global markets. TAVALISSE is commercially available in Europe under the brand name TAVLESSE, in Japan and South Korea and Asia, and in Canada and Israel via our partners, Grifols, Kissei, and Medison Pharma. In addition, our partners continue to pursue regulatory approvals for TAVALISSE in new markets. We continue to work on expanding access to our products in markets outside of the US. For REZLIDHIA in 2024, we expanded our relationship with Kissei to include several countries in Asia for all potential indications, and we entered into an exclusive license agreement with Dr. Reddy's Laboratories for all potential indications throughout Dr. Reddy's Laboratories' territories. These partners are now in the process of advancing REZLIDHIA in preparation for future potential regulatory submissions.

Speaker #4: Driven by the availability of Avelis in global markets, Avelis is commercially available in Europe under the brand name Tavles, in Japan and South Korea and Asia, and in Canada and Israel via our partners Gripple, Kise, and Medison.

Speaker #4: In addition, our partners continue to pursue regulatory approvals for Avelis in new markets, and we continue to work on expanding access to our products in markets outside of the U.S. for Resilia in 2024.

Speaker #4: We expanded our relationship with Kise to include several countries in Asia for all potential indications. And we entered into an exclusive license agreement with Dr. Reddy's for all potential indications throughout Dr. Reddy's territories.

Speaker #4: These partners are now in the process of advancing Resilia in preparation for future potentially potential regulatory submissions. We are pleased that access to our products is expanding outside the US.

David Santos: We are pleased that access to our products is expanding outside the US. With that, I'll now pass the call over to Lisa to provide an update on our development pipeline. Lisa?

Dave Santos: We are pleased that access to our products is expanding outside the US. With that, I'll now pass the call over to Lisa to provide an update on our development pipeline. Lisa?

Speaker #4: And with that, I'll now pass the call over to Lisa to provide an update on our development pipeline. Lisa?

Speaker #5: Thanks, Dave. I will now provide an update on our progress over the first quarter and plans for the remainder of the year. I'm on slide 14.

Lisa Rojkjaer: Thanks, Dave. I will now provide an update on our progress over the Q1 and plans for the remainder of the year. I'm on slide 14. Our hematology and oncology pipeline focus is the clinical development of R289, our potent and selective dual IRAK1 and IRAK4 inhibitor in lower-risk myelodysplastic syndrome, or MDS, and the expansion of olutasidenib beyond relapsed or refractory IDH1-mutated AML in collaboration with academic partners. Our Phase 1b study of R289 in patients with relapsed or refractory lower risk MDS is progressing well. Shortly, I'll provide an update on the study as well as our planned next steps for R289. As far as olutasidenib development is concerned, our strategic collaborations continue to advance into additional therapeutic areas. MD Anderson is evaluating olutasidenib in several IDH1 mutation positive indications, including AML, MDS, and CMML.

Speaker #5: Our hematology and oncology pipeline focus is the clinical development of R289, our potent and selective dual IRAC1 and IRAC4 inhibitor in lower-risk myelodysplastic syndrome, or MDS, and the expansion of elutosignet beyond relapsed to refractory IDH1-mutated AML in collaboration with academic partners.

Speaker #5: Our phase 1B study of R289 in patients with relapsed to refractory lower-risk MDS is progressing well. Shortly, I'll provide an update on the study as well as our planned next steps for R289.

Speaker #5: As far as elutosignet development is concerned, our strategic collaborations continue to advance into additional therapeutic areas. MD Anderson is evaluating elutosignet in several IDH1-mutation-positive indications, including AML, MDS, and CMML.

Speaker #5: In addition, elutosignet is also being evaluated as a maintenance therapy and as a co-targeted therapy in AML. The five MD Anderson studies are active and enrolling.

Lisa Rojkjaer: In addition, olutasidenib is also being evaluated as a maintenance therapy and as a co-targeted therapy in AML. The five MD Anderson studies are active and enrolling. CONNECT's Phase 2 TarGeT-D study evaluating olutasidenib in combination with temozolomide, followed by olutasidenib monotherapy as maintenance treatment in newly diagnosed pediatric and young adult patients with IDH1 mutation positive High-Grade Glioma is also active and enrolling patients. Lastly, we're partnering with the National Institutes of Health and National Cancer Institute's MyeloMatch Precision Medicine Trial Initiative. The planned study will evaluate olutasidenib in first-line IDH1-mutated AML and MDS. We're excited about olutasidenib's potential to provide a new treatment option in these underserved patient populations and look forward to seeing the data that these studies generate in the future. Now I will discuss R289, our novel dual IRAK1 and IRAK4 inhibitor. I'm on slide 16.

Speaker #5: Connex phase 2 target D study evaluating elutosignet in combination with temozolomide followed by elutosignet monotherapy as maintenance treatment in newly diagnosed pediatric and young adult patients with IDH1-mutation-positive high-grade glioma is also active and enrolling patients.

Speaker #5: Lastly, we're partnering with the National Institutes of Health and National Cancer Institutes' Myelomatch Precision Medicine trial initiative. The planned study will evaluate elutosignet in first-line IDH1-mutated AML and MDS.

Speaker #5: We're excited about elutosignet's potential to provide a new treatment option in these underserved patient populations, and look forward to seeing the data that these studies generate in the future.

Speaker #5: Now I will discuss R289, our novel dual IRAC1 and IRAC4 inhibitor. I'm on slide 16. I'd like to remind you about the treatment landscape for lower-risk MDS.

Lisa Rojkjaer: I'd like to remind you about the treatment landscape for lower risk MDS. MDS is a clonal disorder of hematopoietic stem cells leading to dysplasia and ineffective hematopoiesis. The main consequences for patients are anemia and transfusion dependence, which adversely impact their quality of life. In addition, infections, iron overload from transfusions, and subsequent organ dysfunction all negatively impact the patient. Therapies used in the upfront setting include erythropoiesis-stimulating agents, or ESAs, if patients are eligible, or luspatercept. Luspatercept and imetelstat are also approved for ESA-failure, transfusion-dependent lower risk MDS patients. Finally, hypomethylating agents, or HMAs, are also approved. However, the percentage of patients achieving transfusion independence is low. With 8-week transfusion independence rates approaching 40% with luspatercept and imetelstat, there is still a need for safe, effective therapies for previously treated transfusion-dependent lower risk MDS patients that are relapsed, refractory to, or ineligible for ESAs.

Speaker #5: MDS is a clonal disorder of hematopoietic stem cells leading to dysplasia and ineffective hematopoiesis. The main consequences for patients are anemia and transfusion dependence, which adversely impact their quality of life.

Speaker #5: In addition, infections, iron overload from transfusions, and subsequent organ dysfunction all negatively impact the patient. Therapies used in the upfront setting include erythropoiesis-stimulating agents, or ESAs, if patients are eligible, or loose powder set.

Speaker #5: Loose powder set in a metal stat are also approved for ESA failure transfusion-dependent lower-risk MDS patients. Finally, hypomethylating agents, or HMAs, are also approved, however the percentage of patients achieving transfusion independence is low.

Speaker #5: With eight-week transfusion independence rates approaching 40% with loose powder set in a metal stat, there is still a need for safe, effective therapies for previously treated transfusion-dependent lower-risk MDS patients that are relapsed, refractory to, or ineligible for ESAs.

Speaker #5: On slide 17 is the value proposition of R289 in lower-risk MDS, which we believe can address the unmet need, particularly for transfusion-dependent patients. There are about 12,000 previously treated lower-risk MDS patients in the US who could benefit from a novel therapy like R289.

Lisa Rojkjaer: On slide 17 is the value proposition of R289 in lower risk MDS, which we believe can address the unmet need, particularly for transfusion-dependent patients. There are about 12,000 previously treated lower risk MDS patients in the US that could benefit from a novel therapy like R289. Dysregulation of inflammatory signaling is key to the pathogenesis of lower risk MDS, IRAK1 and 4 mediate this process. Blocking both IRAK1 and 4 may suppress marrow inflammation and leukemic stem and progenitor cell function and restore normal hematopoiesis. R835, the active moiety of R289, blocks Toll-like receptor and IL-1 receptor signaling in vitro and was active in various preclinical models of inflammation. Clinical proof of concept of this anti-inflammatory effects came from a healthy volunteer study in which R835 markedly suppressed LPS-induced cytokine release compared to placebo.

Speaker #5: This regulation of inflammatory signaling is key to the pathogenesis of lower-risk MDS, and IRAK1 and 4 mediate this process. Blocking both IRAK1 and 4 may suppress marrow inflammation and leukemic stem and progenitor cell function, and restore normal hematopoiesis.

Speaker #5: R835, the active moiety of R289, blocks toll-like receptor and IL-1 receptor signaling in vitro, and was active in various preclinical models of inflammation. Clinical proof of concept of this anti-inflammatory effect came from a healthy volunteer study in which R835 markedly suppressed LPS-induced cytokine release compared to placebo.

Speaker #5: As a reminder, R289, which is currently being evaluated in the clinic, is the oral prodrug that is rapidly converted to R835 in the gut.

Lisa Rojkjaer: As a reminder, R289, which is currently being evaluated in the clinic, is the oral prodrug that is rapidly converted to R835 in the gut. From the FDA, R289 has both Fast Track designation for the treatment of patients with previously treated transfusion-dependent lower-risk MDS and Orphan Drug designation for MDS. Both designations underscore the agency's interest in this rare disease, the unmet need of the patient population, and the agency's willingness to collaborate with Rigel in the development of R289. R289 has thus far demonstrated a promising clinical profile with both encouraging preliminary safety and efficacy in our Phase Ib study, which was presented at ASH this past December. Now on slide 18, you can see the design of our multicenter open label Phase Ib study in patients with relapsed/refractory lower-risk MDS.

Speaker #5: From the FDA, R289 has both fast-track designation for the treatment of patients with previously treated transfusion-dependent lower-risk MDS and orphan drug designation for MDS.

Speaker #5: Both designations underscore the agency's interest in this rare disease: the unmet need of the patient population and the agency's willingness to collaborate with Rigel in the development of R289.

Speaker #5: R289 has thus far demonstrated a promising clinical profile, with both encouraging preliminary safety and efficacy in our Phase 1b study, which was presented at ASH this past December.

Speaker #5: Now on slide 18, you can see the design of our multi-center open-label phase 1B study in patients with relapsed refractory lower-risk MDS. The phase 1B study evaluates the safety, tolerability, PK, or pharmacokinetics, and preliminary efficacy of R289 in patients with lower-risk MDS and is also designed to select a dose for future studies.

Lisa Rojkjaer: The Phase 1b study evaluates the safety, tolerability, PK, or pharmacokinetics, and preliminary efficacy of R289 in patients with lower-risk MDS and is also designed to select a dose for future studies. The dose escalation phase evaluated 6 different R289 dosing regimens that are administered once or twice daily using a modified 3 plus 3 design. In the dose expansion part of the study, which is currently enrolling, up to 40 transfusion-dependent relapsed/refractory lower-risk MDS patients are being randomized to receive R289 doses of either 500 milligrams once or twice daily in order to select the recommended Phase 2 dose for future clinical studies. On slide 19, you'll see highlights from the dose escalation phase data that were presented at the ASH meeting in December.

Speaker #5: The dose escalation phase evaluated six different R289 dosing regimens that are administered once or twice daily using a modified 3+3 design. In the dose expansion part of the study, which is currently enrolling, up to 40 transfusion-dependent relapsed refractory lower-risk MDS patients are being randomized to receive R289 doses of either 500 milligrams once or twice daily in order to select the recommended phase 2 dose for future clinical studies.

Speaker #5: On slide 19, you'll see highlights from the dose escalation phase data that were presented at the ASH meeting in December. I encourage you to review the corporate presentation in the investor section of our website, which includes the full dataset.

Lisa Rojkjaer: I encourage you to review the corporate presentation in the investor section of our website, which includes the full data set. 33 patients were enrolled. The median age was 75, and the median number of prior therapies was 3, with around 70% of the patients having received prior luspatercept and HMAs. In addition, the majority of the patients had a high baseline transfusion burden. This elderly, heavily pretreated patient population is truly representative of the low-risk MDS patient population with the highest unmet medical need. Overall, R289 was generally well-tolerated with a low incidence of grade 3 or 4 cytopenias and infections. There was 1 dose-limiting toxicity reported, a grade 3/4 AST, ALT increase of 750 milligram daily dose level and no evidence of dose-dependent toxicity across the other dose groups.

Speaker #5: 33 patients were enrolled, the median age was 75, and the median number of prior therapies was 3, with around 70% of the patients having received prior loose powder set and HMAs.

Speaker #5: In addition, the majority of the patients had a high baseline transfusion burden. This elderly, heavily pretreated patient population is truly representative of the low-risk MDS patient population with the highest unmet medical need.

Speaker #5: Overall, R289 was generally well tolerated, with a low incidence of grade 3 or 4 cytopenias and infections. There was one dose-limiting toxicity reported—a grade 3/4 AST/ALT increase—at the 750 milligram daily dose level, and no evidence of dose-dependent toxicity across the other dose groups.

Speaker #5: The swimmer plot you see shows an overview of transfusion events by dose group, starting with the lowest dose group, 250 milligrams daily at the top.

Lisa Rojkjaer: The swimmer plot you see shows an overview of transfusion events by dose group, starting with the lowest dose group, 250 mg daily at the top. Red cell transfusions occurring over 16 weeks prior to start of R289 are shown to the left of the colored bars, establishing the baseline transfusion frequency for each patient. Of 18 evaluable patients receiving doses of 500 mg daily or higher, 6 patients or 33% achieved red cell transfusion independence or RBCTI lasting for 8 weeks or longer. In 4 patients, RBCTI lasted for more than 16 weeks, and for 3 patients for more than 6 months. The median duration of RBCTI was around 23 weeks, ranging from 9 weeks to more than 24 months. Also, the median time to onset of RBCTI was about 2 months.

Speaker #5: Red cell transfusions occurring over 16 weeks prior to the start of R289 are shown to the left of the colored bars, establishing the baseline transfusion frequency for each patient.

Speaker #5: Of 18 evaluable patients receiving doses of 500 milligrams daily or higher, six patients, or 33%, achieved red cell transfusion independence, or RBCTI, lasting for eight weeks or longer.

Speaker #5: In four patients, RBCTI lasted for more than 16 weeks, and for three patients, for more than six months. The median duration of RBCTI was around 23 weeks, ranging from nine weeks to more than 24 months.

Speaker #5: Also, the median time to onset of RBCTI was about two months. While this is a small dataset, we're encouraged by these results given the highly refractory nature of these patients.

Lisa Rojkjaer: While this is a small data set, we're encouraged by these results given the highly refractory nature of these patients. In summary, R289 was generally well-tolerated with an encouraging safety profile and promising preliminary efficacy in an elderly, heavily pretreated transfusion-dependent lower-risk MDS patient population. The next steps for our R289 clinical development program are on slide 20. We plan to complete enrollment of the dose expansion phase of the study and select the recommended Phase 2 dose for future studies in the H2 of this year. We anticipate sharing an update on the study, including top-line data from the dose expansion phase by the end of 2026.

Speaker #5: In summary, R289 was generally well tolerated, with an encouraging safety profile and promising preliminary efficacy in an elderly, heavily pretreated, transfusion-dependent, lower-risk MDS patient population.

Speaker #5: The next steps for our R289 clinical development program are on slide 20. We plan to complete enrollment of the dose expansion phase of the study and select the recommended phase 2 dose for future studies in the second half of this year.

Speaker #5: We anticipate sharing an update on the study, including top-line data from the dose expansion phase, by the end of 2026. Once the recommended Phase 2 dose has been selected, we will evaluate R289 in a cohort of less heavily pretreated patients who are relapsed refractory to, or ineligible for, ESAs in the same study.

Lisa Rojkjaer: Once the recommended Phase 2 dose has been selected, we will evaluate R289 in a cohort of less heavily pretreated patients who are relapsed/refractory to or ineligible for ESAs in the same study. Upon completion of the Phase 1b study, we plan to follow up with the FDA to discuss a potential registration study, which we'll potentially initiate in 2027. With its mechanism of action, we believe that R289 has potential in other indications where the pro-inflammatory cascade plays a role, and we'll provide more details as our plans progress. Now I'll pass the call to Dean to discuss our results for the quarter. Dean?

Speaker #5: Upon completion of the Phase 1B study, we plan to follow up with the FDA to discuss a potential registration study, which will potentially initiate in 2027.

Speaker #5: With its mechanism of action, we believe that R289 has potential in other indications where the pro-inflammatory cascade plays a role, and we'll provide more details as our plans progress.

Speaker #5: Now I'll pass the call to Dean to discuss our results for the quarter. Dean?

Speaker #6: Thank you, Lisa. I'm on slide 22. We reported net product sales of 54.9 million dollars for the first quarter, a growth of 26% year over year, including tobolise net product sales of 37.3 million dollars, a growth of 31% year over year.

Dean Schorno: Thank you, Lisa. I'm on slide 22. We reported net product sales of $54.9 million for Q1, a growth of 26% year over year, including TAVALISSE net product sales of $37.3 million, a growth of 31% year over year. Lastly, we reported GAVRETO net product sales of $9.6 million, a growth of 7% year over year. Lastly, we reported REZLIDHIA net product sales of $8 million, a growth of 31% year over year. Our net product sales were recorded net of estimated discounts, charge-backs, rebates, returns, co-pay assistance, and other allowances of $20.5 million.

Speaker #6: Gavretto net product sales of 9.6 million dollars, a growth of 7% year over year, lastly, we reported Reslidia net product sales of 8 million dollars, a growth of 31% year over year, our net product sales were recorded net of estimated discounts chargebacks, rebates, returns, copay assistance, and other allowances of 20.5 million dollars.

Speaker #6: We also reported 3.9 million dollars in contract revenues for the first quarter, primarily consisting of 1.8 million dollars of revenue from Griffols related to earned royalties, 1.8 million dollars of revenues from Keysave related to the delivery of drug supplies, and 300,000 dollars of revenue from Medison related to delivery of drug supply and earned royalties.

Dean Schorno: We also reported $3.9 million in contract revenues for Q1, primarily consisting of $1.8 million of revenue from Grifols related to earned royalties, $1.8 million of revenues from Kissei related to the delivery of drug supplies, and $300,000 of revenue from Medison related to delivery of drug supply and earned royalties. This brings our total revenue for Q1 to $58.8 million. Moving to slide 23. For Q1 of 2026, our cost of product sales was approximately $4.6 million. Total costs and expenses were $46.9 million compared to $40.6 million for the same period of 2025.

Speaker #6: This brings our total revenue for the first quarter to 58.8 million dollars. Moving to slide 23. For the first quarter of 2026, our cost of product sales was approximately 4.6 million dollars.

Speaker #6: Total cost and expenses were 46.9 million dollars, compared to 40.6 million dollars for the same period of 2025. The increase in cost and expenses was primarily due to increased research and development costs, driven by the timing of clinical activities related to R289, as well as increased commercial-related expenses and personnel-related costs.

Dean Schorno: The increase in cost and expenses was primarily due to increased research and development costs driven by the timing of clinical activities related to R289, as well as increased commercial-related expenses and personnel-related costs. Income before income taxes was $11.7 million. We reported net income of $8.7 million for Q1 compared to net income of $11.4 million in the same period in 2025. We ended the quarter with cash equivalents, and short-term investments of $146.7 million compared to $155 million as of the end of 2025. Turning to our financial outlook for 2026. We continue to expect total revenue in the range of approximately $275 to 290 million.

Speaker #6: Income before income taxes was 11.7 million dollars. We reported net income of 8.7 million dollars for the first quarter, compared to net income of 11.4 million dollars in the same period in 2025.

Speaker #6: We ended the quarter with cash, cash equivalents, and short-term investments of 146.7 million dollars, compared to 155 million dollars as of the end of 2025.

Speaker #6: Turning to our financial outlook for 2026, we continue to expect total revenue in the range of approximately 275 to 290 million dollars. This includes our expectation of approximately 255 to 265 million dollars in net product sales and 20 to 25 million dollars of contract revenues.

Dean Schorno: This includes our expectation of approximately $255 to 265 million in net product sales and $20 to 25 million of contract revenues. We also anticipate reporting positive net income for the full year while funding existing and new clinical development opportunities. Before I turn the call back over to Raul, I'd like to also describe two recent updates. In mid-April, we received notification from Lilly that they will terminate the collaboration with Rigel, which included the development of ocadusertib, previously R552, the RIPK1 asset that was being evaluated in a phase 2 study in adult patients with moderately to severely active rheumatoid arthritis. The termination will become effective on 15 June 2026. As a reminder, the CNS portion of the collaboration was previously terminated in November 2025.

Speaker #6: We also anticipate reporting positive net income for the full year, while funding existing and new clinical development opportunities. Before I turn the call back over to Raul, I'd like to also describe two recent updates.

Speaker #6: In mid-April, we received notification from Lily that they will terminate the collaboration with Rigel which included the development of OCAD assertive, previously R552, the RIP K1 asset that was being evaluated in phase 2 study in adult patients with moderately to severely active rheumatoid arthritis.

Speaker #6: The termination will become effective on June 15, 2026. As a reminder, the CNS portion of the collaboration was previously terminated in November 2025.

Speaker #6: We expect to regain rights to the program upon termination. Let me remind you that our revenue guidance does not include any assumed revenues from the Lilly collaboration.

Dean Schorno: We expect to regain rights to the program upon termination. Let me remind you that our revenue guidance does not include any assumed revenues from Lilly collaboration. In addition, the termination does not impact our ability to finance our operations. Earlier today, we restructured our debt agreement with MidCap Financial to replace our existing term loan credit facility with a revolving credit facility. Rigel repaid the remaining outstanding term loan balance of $40 million and now has a revolving credit facility for $40 million with an option to increase it to $60 million subject to customary conditions. We've drawn down $8 million on the new revolving credit facility. We believe this agreement provides us with a cost-efficient source of flexible financing into the future. With that, I'd like to turn the call back over to Raul. Raul?

Speaker #6: In addition, the termination does not impact our ability to finance our operations. Finally, earlier today, we restructured our debt agreement with Midcap Financial to replace our existing term loan credit facility with a revolving credit facility.

Speaker #6: Rigel repaid the remaining outstanding term loan balance of $40 million and now has a revolving credit facility for $40 million, with an option to increase it to $60 million, subject to customary conditions.

Speaker #6: We've drawn down 8 million dollars on the new revolving credit facility. We believe this agreement provides us with a cost-efficient source of flexible financing into the future.

Speaker #6: With that, I'd like to turn the call back over to Raul. Raul?

Speaker #7: Thank you, Dean. Moving on to slide 24. To wrap up, our key priorities for the remainder of 2026 are clear. Continue to grow our commercial business, pursue in-license opportunities to further expand our portfolio, advance our development pipeline with the focus on R289 in lower-risk MDS and potentially other indications, and maintain financial discipline, as we work to deliver yet another year of top-line growth and positive net income.

Raul Rodriguez: Thank you, Dean. Moving on to slide 24. To wrap up, our key priorities for the remainder of 2026 are clear. Continue to grow our commercial business, pursue in-license opportunities to further expand our portfolio, advance our development pipeline with a focus on R289 in lower risk MDS and potentially other indications, and maintain financial discipline as we work to deliver yet another year of top line growth and positive net income. We are proud of the transformational growth that Rigel has achieved over the past several years. We're excited to continue executing on our four strategic objectives to drive long-term value creation in the years ahead. With that, I would like to turn the call over to your questions. Operator, we are ready.

Speaker #7: We are proud of the transformational growth that Rigel has achieved over the past several years, and we're excited to continue executing on our four strategic objectives to drive long-term value creation in the years ahead.

Speaker #7: With that, I would like to turn the call over to your questions, and Operator, we are ready.

Speaker #8: Thank you. If you would like to ask a question, please press star one on your telephone keypad. A confirmation call will indicate your line is in the question queue.

Operator 2: Thank you. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys. One moment please while we pull for a question. Our first question comes from the line of Yigal Nochomovitz with Citigroup. Please proceed with your question.

Operator: Thank you. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys. One moment please while we pull for a question. Our first question comes from the line of Yigal Nochomovitz with Citigroup. Please proceed with your question.

Speaker #8: You may press star two to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys.

Speaker #8: One moment, please, while we pull for questions. Our first question comes from the line of Yigal Nechomovitz with Citigroup. Please proceed with your question.

Speaker #5: Hi, this is Caroline on for Yigal. Thanks for taking our question, and congrats on the quarter. Can you please talk about your plans for the RIPK1 inhibitor now, and maybe comment on Lilly's rationale for terminating the agreement?

[Analyst] (Citigroup): Hi, this is Caroline on for Yigal. Thanks for taking our question, and congrats on the quarter. Can you please talk about your plans for the RIPK1 inhibitor now, and maybe comment on Lilly's rationale for terminating the agreement? Thanks.

Speaker #5: Thanks.

Speaker #7: Sure. Thank you. I could answer that question. And thank you for asking that because it gives me a chance to thank our colleagues at Lily for the collaborative spirit and diligence that they showed throughout our collaboration.

Raul Rodriguez: Sure. Thank you. I could answer that question. And thank you for asking that 'cause it gives me a chance to thank our colleagues at Lilly for the collaborative spirit and diligence that they showed throughout our collaboration. We put it though in the framework of what Rigel is and how it fits within Rigel. Rigel is a hematology/oncology-focused company. We have a growing commercial business. We are profitable, and we have a pipeline in hematology/oncology with tremendous opportunities. We did this deal with RIPK1 inhibitors with Lilly because the primary focus of RIPK1 inhibitors is in immunology and CNS diseases. Those we felt were best suited to a larger pharma company like Lilly that had interest in those areas and the resources to explore the opportunity there.

Speaker #7: We put the collaborator—let me put it, though, in the framework of what Rigel is and how it fits within Rigel. Rigel is a hematology-oncology-focused company.

Speaker #7: We have a growing commercial business. We are profitable, and we have a pipeline in hematology-oncology with tremendous opportunities. We did this deal with RIP Kinase with Lilly because the primary focus of RIP Kinase is in immunology and CNS diseases.

Speaker #7: And those we felt were best suited to a larger pharma company like Lily that had interest in those areas, and the resources to explore the opportunity there.

Speaker #7: For us, though, it was really a financial upside that this provided, and really not a strategic focus of ours. So it suited us well in terms of having a partnership.

Raul Rodriguez: For us, though, it was really a financial upside that this provided and really not a strategic focus of ours. It suited us well in terms of having a partnership. That was the rationale. Now getting it back, I think, we'll assess what to do as a next step. It's not a key focus of this company, and we'll decide what we do as a next step going forward in the near future. Again, thank you for the partnership that and our colleagues at Lilly over these years.

Speaker #7: That was the rationale. Now, getting it back, I think we're—we'll assess what to do as a next step; it's not of key focus of this company.

Speaker #7: And we'll decide what we do as a next step going forward in the near future. But again, thank you for the partnership with our colleagues at Lilly over these years.

Speaker #5: Thanks.

[Analyst] (Citigroup): Thanks.

Speaker #8: Thank you. Our next question comes from the line of Joe Panginis with HC Wainwright. Please proceed with your question.

Operator 2: Thank you. Our next question comes from the line of Joseph Pantginis with H.C. Wainwright & Co. Please proceed with your question.

Operator: Thank you. Our next question comes from the line of Joseph Pantginis with H.C. Wainwright & Co. Please proceed with your question.

Speaker #9: Everybody, good afternoon. Thanks for taking the question. So first, I just wanted to check on your agility comment. Obviously, the blocking and tackling continues with the academic centers, but with regard to growing the community centers, obviously, it's educating them in the post-vent setting, as you described.

Joseph Pantginis: Everybody, good afternoon. Thanks for taking the question. First, I just wanted to check on your REZLIDHIA comment. Obviously, the blocking and tackling continues with the academic centers. With regard to growing the community centers, obviously, it's educating them in the post-venetoclax setting as you described. Are there any other drivers or key factors that I don't want to call it rate-limiting steps, but things that you feel need additional work?

Joe Pantginis: Everybody, good afternoon. Thanks for taking the question. First, I just wanted to check on your REZLIDHIA comment. Obviously, the blocking and tackling continues with the academic centers. With regard to growing the community centers, obviously, it's educating them in the post-venetoclax setting as you described. Are there any other drivers or key factors that I don't want to call it rate-limiting steps, but things that you feel need additional work?

Speaker #9: Are they—are there any other drivers or key factors that are—I don't want to call it rate-limiting steps, but things that you feel need additional work?

Speaker #7: I think you've got it there, Joe. This is Dave, by the way. Sorry. I just wanted to reiterate that the post-vent setting is really important to community clinicians because that is their standard of care.

David Santos: I think, you've got it there, Joe. This is Dave, by the way. Sorry.

Dave Santos: I think, you've got it there, Joe. This is Dave, by the way. Sorry.

Joseph Pantginis: Hi, David.

Joe Pantginis: Hi, David.

David Santos: I just wanted to reiterate that the post-ven setting is really important to community clinicians because that is their standard of care in the front-line setting. Helping them to become aware of our data in the post-venetoclax setting is compelling to them. That's number one. I do think, you know, in terms of challenges in the community, you'll have to recognize that community physicians do not treat AML every day. In fact, they don't see IDH1 mutated AML very often. At all, even less than the AML they see because IDH1 is a subset of that. Force of habit is to go to something they know. As you know, the other agent in the class has been out for a long time.

Dave Santos: I just wanted to reiterate that the post-ven setting is really important to community clinicians because that is their standard of care in the front-line setting. Helping them to become aware of our data in the post-venetoclax setting is compelling to them. That's number one. I do think, you know, in terms of challenges in the community, you'll have to recognize that community physicians do not treat AML every day. In fact, they don't see IDH1 mutated AML very often. At all, even less than the AML they see because IDH1 is a subset of that. Force of habit is to go to something they know. As you know, the other agent in the class has been out for a long time.

Speaker #7: In the frontline setting, and so helping them to become aware of our data in the post-venetoclax setting is compelling to them. So that's number one.

Speaker #7: I do think in terms of challenges in the community, you'll have to recognize that community physicians do not treat AML every day. And in fact, they don't see IDH1 mutated AML very often.

Speaker #7: And so at all, even less than the AML they see because IDH1 is a subset of that. And so force of habit is to go to something they know.

Speaker #7: And as you know, the other agent in the class has been out for a long time. And so it is a force of habit that we need to overcome.

David Santos: It is a force of habit that we need to overcome. The key is getting the right message to them at the right time, and that's when they have an IDH1 applicable patient. That's what we've spent a lot of time trying to figure out. How do we help our field team get to accounts, community accounts in particular, at the right time with that message? We've done a lot of work around that, not only using diagnostic data, but even, like, combing through medical data, patient journey data, to really understand when that patient may occur. That's what we provide our field with, that's what they target with, and that's when they go and deliver the appropriate REZLIDHIA message. Those are the challenges we face, but, you know, like you said, it's really simple.

Dave Santos: It is a force of habit that we need to overcome. The key is getting the right message to them at the right time, and that's when they have an IDH1 applicable patient. That's what we've spent a lot of time trying to figure out. How do we help our field team get to accounts, community accounts in particular, at the right time with that message? We've done a lot of work around that, not only using diagnostic data, but even, like, combing through medical data, patient journey data, to really understand when that patient may occur. That's what we provide our field with, that's what they target with, and that's when they go and deliver the appropriate REZLIDHIA message. Those are the challenges we face, but, you know, like you said, it's really simple.

Speaker #7: And the key is getting the right message to them at the right time. And that's when they have an IDH1 applicable patient. And that's what we've spent a lot of time trying to figure out: how do we help our field team get to accounts, community accounts in particular, at the right time with that message?

Speaker #7: And we've done a lot of work around that, not only using diagnostic data but even combing through medical data, patient journey data, to really understand when that patient may occur.

Speaker #7: So that's what we provide our field with. That's what they target with, and that's when they go and deliver the appropriate resolute message. So those are the challenges we face.

Speaker #7: But like you said, it's really simple. If you can get them the compelling message at the right time when they're treating an IDH1 patient, the data itself is very compelling, and can hopefully get them to use resolute.

David Santos: If you can get them the compelling message at the right time when they're treating an IDH1 patient, the data itself is very compelling and can hopefully get them to use REZLIDHIA.

Dave Santos: If you can get them the compelling message at the right time when they're treating an IDH1 patient, the data itself is very compelling and can hopefully get them to use REZLIDHIA.

Speaker #9: That's very helpful. Thank you very much. And maybe on our 289, and obviously, this is looking forward into the future a little bit. So it's encouraging and nice that we're seeing rapid and rapid expansion into the dose expansion study, no pun intended again, looking to get the RP2D and as we look towards data later this year, presumably Ash, I'll say, what would you consider or how would you portray to the street what would be the important benchmarks or signals you would want to see to then be able to go to the FDA for a potential registrational study design?

Joseph Pantginis: That's very helpful. Thank you very much. Maybe on R289, obviously, this is looking forward into the future a little bit. It's encouraging and nice that we're seeing rapid and rapid expansion into the dose expansion study, no pun intended again, looking to get the RP2D. As we look towards data later this year, presumably ASH, I'll say, you know, what would you consider or how would you portray to the street what would be the important benchmarks or signals you would want to see to then be able to go to the FDA for a potential registrational study design?

Joe Pantginis: That's very helpful. Thank you very much. Maybe on R289, obviously, this is looking forward into the future a little bit. It's encouraging and nice that we're seeing rapid and rapid expansion into the dose expansion study, no pun intended again, looking to get the RP2D. As we look towards data later this year, presumably ASH, I'll say, you know, what would you consider or how would you portray to the street what would be the important benchmarks or signals you would want to see to then be able to go to the FDA for a potential registrational study design?

Speaker #7: Can you say a few comments, Lisa, and I can add a comment after?

Raul Rodriguez: Lisa, go ahead. If you would comment, Lisa, and I can add a comment after.

Speaker #4: Okay, sure. Thanks for the question, Joe. I think it's an excellent question. I think that when you look at the current approved therapies, these are approved in patients that are transfusion-dependent, either post-DSA or DSA naive.

Lisa Rojkjaer: Okay, sure. Thanks for the question, Joe. I think it's an excellent question. I think that, you know, when you look at the current approved therapies, these are approved in patients that are transfusion-dependent, either post-ESA or ESA-naive. We see that, you know, the 8-week RBCTI rates are only around 38% to 40%. Now, we are enrolling a population of much more heavily pre-treated. We've got patients that have received prior imetelstat, luspatercept, and HMAs. Thus far, we're very pleased with the activity that we're seeing.

Speaker #4: And we see that the RB eight-week RBCTI rates are only around 38 to 40 percent. Now, we are enrolling a population of much more heavily pretreated.

Speaker #4: We've got patients that have received prior imetostat loose powder sept and HMAs. And thus far, we're very pleased with the activity that we're seeing.

Speaker #4: So I think that when we consider the difference in the patient population, I think if we can see more—if we see consistent safety is what we've seen thus far, and additional evidence of activity, I think we're going to be really pleased with that.

Lisa Rojkjaer: I think that when we consider the difference in the patient populations, I think, you know, if we can see more, if we see consistent safety is what we've seen thus far and, you know, additional evidence of activity, I think we're gonna be really pleased with that. In addition, you may recall that we saw data showing that R289 also improves anemia in the patients in our study, which is not always a given. We were very pleased with that as well.

Speaker #4: In addition, you may recall that we saw data showing that our 289 also improves anemia in the patients in our study, which is not always a given.

Speaker #4: So we were very pleased with that as well.

Speaker #7: So if I should say, I think there's several places we could slot in with this product. And there are very large segments across the board.

Raul Rodriguez: And Joe, if I should say, I think, there's several places we could slot in with this product. There are very large segments across the board. I think it's exciting to have a novel agent that's completely different than what's out there. I think that's a very important feature. An oral agent, easy to take on a more chronically basis. I think one of several positions within that landscape that Lisa discussed, I think would be transformational for us. We'll wait to see the data, the early data being, as Lisa said, very encouraging. We look to see that in much larger numbers at the end of this year, so we can make that final assessment as to how to pursue.

Speaker #7: I think it's exciting to have a novel agent that's completely different than what's out there. I think that's a very important feature—an oral agent, easy to take on a more chronic basis.

Speaker #7: And I think one of several positions within that landscape that Lisa discussed, I think, would be transformational for us. And we'll wait to see the data.

Speaker #7: The early data being as Lisa said, very encouraging, but we look to see that in much larger numbers at the end of this year.

Speaker #7: So we can make that final assessment as to how to proceed.

Speaker #9: Great. Appreciate the color.

Joseph Pantginis: Great. Appreciate the color.

Joe Pantginis: Great. Appreciate the color.

Speaker #10: Thank you. Our next question comes from the line of Kristen Kluska with Cantor Fitzgerald. Please proceed with your question.

Operator 2: Thank you. Our next question comes from the line of Kristen Kluska with Cantor Fitzgerald. Please proceed with your question.

Operator: Thank you. Our next question comes from the line of Kristen Kluska with Cantor Fitzgerald. Please proceed with your question.

Speaker #11: Hi. This is Ayan on Kristen's line. Thank you for taking my question. On our 289, what do you see as an acceptable safety profile here?

[Analyst] (Cantor Fitzgerald): Hi, this is Aya on Kristen's line. Thank you for taking our question. On R289, what do you see as an acceptable safety profile here, and how will that play into the dose selection for the phase 2?

Ayan Hussein: Hi, this is Aya on Kristen's line. Thank you for taking our question. On R289, what do you see as an acceptable safety profile here, and how will that play into the dose selection for the phase 2?

Speaker #11: And how will that play into the dose selection for the Phase 2?

Speaker #7: Lisa?

Raul Rodriguez: Lisa?

Speaker #4: Yeah. Thanks for the question. I think that what we're seeing thus far is very encouraging compared to the currently approved agents. And by that, I mean we're with an elderly patient population median age of 75, heavily pretreated.

Lisa Rojkjaer: Yeah. Thanks, thanks for the question. I think that what we're seeing thus far is very encouraging compared to the currently approved agents. By that I mean we're with an elderly patient population, median age of 75, heavily pre-treated. We're seeing a very low incidence of cytopenias and infections. I think, also, as Raul mentioned, in combination with the fact that we have an oral agent, I think this is very encouraging. We're very pleased with that, and we hope that we continue to see that as we enroll more patients into the study.

Speaker #4: We're seeing a very low incidence of cytopenias and infections. And I think also, as Israel mentioned, in combination with the fact that we have an oral agent, I think this is very encouraging.

Speaker #4: So we're very pleased with that. And we hope that we continue to see that as we enroll more patients into the study.

Speaker #7: Thank you for the question.

Raul Rodriguez: Thank you for the.

Speaker #10: Thank you. Our next question comes from the line of Farzan Aki with Jefferies. Please proceed with your question.

[Analyst] (Cantor Fitzgerald): Thank you.

Ayan Hussein: Thank you.

Operator 2: Thank you. Our next question comes from the line of Farzin Haque, with Jefferies. Please proceed with your question.

Operator: Thank you. Our next question comes from the line of Farzin Haque, with Jefferies. Please proceed with your question.

Speaker #12: Hi, this is Amin On for Farzan. Thank you for taking our questions. A couple of questions from us. For Gavrita revenue, it seems like it's plateauing in one queue.

[Analyst] (Jefferies): Hi, this is Amin on for Farzin. Thank you for taking our questions. A couple questions from us. For GAVRETO revenue, it seems like that it's plateauing in Q1. What has been the feedback from the sales team and prescribers? Any color on new patient starts versus switches? What's the persistence rate so far? Then I have a follow-up for R289.

Amin Daneshbodi: Hi, this is Amin on for Farzin. Thank you for taking our questions. A couple questions from us. For GAVRETO revenue, it seems like that it's plateauing in Q1. What has been the feedback from the sales team and prescribers? Any color on new patient starts versus switches? What's the persistence rate so far? Then I have a follow-up for R289.

Speaker #12: What has been the feedback from the sales team and prescribers? Any color on new patient starts versus switches? And what's the persistence rate so far?

Speaker #12: And then I have a follow-up for 289.

Speaker #7: If you want to try to answer there, Gavrita Revenue plateau in any color?

Raul Rodriguez: If you wanna answer the GAVRETO revenue plateau with any color?

Speaker #4: Yeah. Was it Amin? I'm sorry. I know you're on for Farzan, but I didn't catch your name. I'm sorry.

David Santos: Yeah, was it Amin? I'm sorry. I know you're on for Farzin, I didn't catch your name. I'm sorry.

Dave Santos: Yeah, was it Amin? I'm sorry. I know you're on for Farzin, I didn't catch your name. I'm sorry.

Speaker #12: That's correct. Amin.

[Analyst] (Jefferies): That's correct, Amin.

Amin Daneshbodi: That's correct, Amin.

Speaker #4: Okay. Sorry, Amin. Yeah. We don't on the calls generally provide details on specific new patient starts or persistency trends. But I'll just say it this way.

David Santos: Okay. Sorry, Amin. Yeah, we don't on the calls, generally provide details on specific new patient starts or persistency trends. I'll just say it this way. What we got in GAVRETO was an asset that you have a very targeted market with high awareness of using a targeted agent, and particularly over the last couple years, especially in lung cancer. There's been a large amount of data out there to clinicians that really reinforce the use of a targeted agent in lung cancer, and that's across EGFR or certainly in RET, where it's shown in the NCCN guidelines that you should be using these. These patients are routinely tested much more so in the academic setting in the community.

Dave Santos: Okay. Sorry, Amin. Yeah, we don't on the calls, generally provide details on specific new patient starts or persistency trends. I'll just say it this way. What we got in GAVRETO was an asset that you have a very targeted market with high awareness of using a targeted agent, and particularly over the last couple years, especially in lung cancer. There's been a large amount of data out there to clinicians that really reinforce the use of a targeted agent in lung cancer, and that's across EGFR or certainly in RET, where it's shown in the NCCN guidelines that you should be using these. These patients are routinely tested much more so in the academic setting in the community.

Speaker #4: What we got in Gavrita was an asset that you have a very targeted market with high awareness of using a targeted agent and particularly over the last couple of years, especially in lung cancer.

Speaker #4: There's been a large amount of data out there to clinicians that really reinforce the use of a targeted agent in lung cancer and that across EGFR or certainly in RET.

Speaker #4: Where it's shown in the NCCN guidelines that you should be using these. So these patients are routinely tested much more so in the academic setting and the community.

Speaker #4: But when they do that, clinicians generally know that there are two available RET inhibitors, and they choose either Gavreta or the other available RET inhibitor.

David Santos: When they do that, clinicians generally know that there are two available RET inhibitors, and they choose either GAVRETO or the other available RET inhibitor. You know, it's been our experience that just keeping the awareness out there for RET and the availability of GAVRETO has helped to ensure our share in that marketplace. I think what you're seeing is, you're right, we saw growth last year, but you have to understand, a significant part of our growth was having a full year versus a half a year of sales. What you're seeing now is a product that's, you know, producing on the order of $10 million a quarter, which I think is a great thing for us.

Dave Santos: When they do that, clinicians generally know that there are two available RET inhibitors, and they choose either GAVRETO or the other available RET inhibitor. You know, it's been our experience that just keeping the awareness out there for RET and the availability of GAVRETO has helped to ensure our share in that marketplace. I think what you're seeing is, you're right, we saw growth last year, but you have to understand, a significant part of our growth was having a full year versus a half a year of sales. What you're seeing now is a product that's, you know, producing on the order of $10 million a quarter, which I think is a great thing for us.

Speaker #4: And it's been our experience that just keeping the awareness out there for RET and the availability of Gavrita has helped to ensure our share in that marketplace.

Speaker #4: So I think what you're seeing is you're right. We saw a growth last year, but you have to understand some of our growth was or a significant part of our growth was having a full year versus a half a year of sales.

Speaker #4: And what you're seeing now is a product that's producing on the order of $10 million a quarter, which I think is a great thing for us.

Speaker #4: But we also want to make sure that we're not expending too much effort to try to grow incrementally on that when we have better opportunities, particularly with resilience ce and tolerance.

David Santos: We also wanna make sure that we're not expending too much effort to try to grow incrementally on that when we have better opportunities, particularly with REZLIDHIA and TAVALISSE. We're focused on the areas that we can grow, excuse me, incremental revenue the most, and that's what we are doing with TAVALISSE and REZLIDHIA.

Dave Santos: We also wanna make sure that we're not expending too much effort to try to grow incrementally on that when we have better opportunities, particularly with REZLIDHIA and TAVALISSE. We're focused on the areas that we can grow, excuse me, incremental revenue the most, and that's what we are doing with TAVALISSE and REZLIDHIA.

Speaker #4: So we're focused on the areas that we can grow, excuse me, incremental revenue the most, and that's what we are doing with tolerance and resilience.

Speaker #7: Thanks, David. You had a 289 question as well?

[Analyst] (Jefferies): That's great. Thank you.

Amin Daneshbodi: That's great. Thank you.

Raul Rodriguez: You have a 289 question as well?

Speaker #12: Yes. For 289, just quickly, are there specific well, if you can actually comment on the patient baseline profile being enrolled right now relative to dose escalation cohorts?

[Analyst] (Jefferies): Yes. For R289, just quickly, Well, if you can actually comment on the patient baseline profile being enrolled right now relative to dose escalation cohorts.

Amin Daneshbodi: Yes. For R289, just quickly, Well, if you can actually comment on the patient baseline profile being enrolled right now relative to dose escalation cohorts.

Speaker #4: So as I mentioned, we anticipate providing an update on the study at the end of the year. So those results will hopefully we'll be able to do that.

Lisa Rojkjaer: As I mentioned, we anticipate providing an update on the study at the end of the year. Those results will, you know, hopefully we'll be able to do that, and those results will be available later.

Speaker #4: And those results will be available later.

Speaker #7: Yeah, we really can't comment so much on the study that's currently enrolling. The expansion—what we can say is that the earlier study, the dose escalation phase, was elderly, heavily pretreated, highly refractory types of patients.

Raul Rodriguez: Yeah. We really can't comment so much on the study that's currently enrolling the expansion. What we can say is that the earlier study, the dose escalation phase, was elderly, heavily pre-treated, highly refractory type of patients. Whether that evolves or not, now that we have some data out there showing that it may have some benefit, is something we don't know yet and haven't shared.

Speaker #7: Whether that evolves or not, now that we have some data out there showing that it may have some benefit, is something we don't know yet and haven't shared.

Speaker #12: Okay. Thanks.

[Analyst] (Jefferies): Okay, thanks.

Amin Daneshbodi: Okay, thanks.

Speaker #10: Thank you.

Operator 2: Thank you.

Operator: Thank you.

Speaker #4: Thank you.

Raul Rodriguez: Thank you.

Speaker #10: Is there no further questions at this time? I'd like to turn the floor back over to Mr. Raul Rodriguez for a closing comment.

Operator 2: I have no further questions at this time. I'd like to turn the floor back over to Mr. Raul Rodriguez for closing comments.

Operator: I have no further questions at this time. I'd like to turn the floor back over to Mr. Raul Rodriguez for closing comments.

Speaker #7: Thank you so much for that. I appreciate all the questions. And for your continued interest in Rigel and what we're doing. Before we leave, I'd also like to thank our employees for their dedication and commitment.

Raul Rodriguez: Thank you so much for that. I appreciate all the questions, and for your continued interest in Rigel and what we're doing. Before we leave, I'd also like to thank our employees for their dedication and commitment, 2026 is up to a solid start. We're pleased with the progress we've made across the businesses, and we look forward to updating you on future calls. Thank you very much. Have a good evening.

Speaker #7: 2026 is up to a solid start. We're pleased with the progress we've made across the businesses. And we look forward to updating you on future calls.

Speaker #7: So thank you very much. Have a good evening.

Operator 2: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Operator: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.