RIGL May 5, 2026

Rigel Pharmaceuticals Q1 2026 Earnings Call - 26% Sales Growth and R289 Pipeline Progress Offset by Lilly Deal Termination

Summary

Rigel Pharmaceuticals delivered a strong start to 2026, with Q1 net product sales jumping 26% to $54.9 million. The growth was led by a 31% surge in TAVALISSE and a matching 31% rise in REZLIDHIA, partially offset by the typical seasonal headwinds of January and February. Management maintained its full-year revenue guidance of $275 million to $290 million and reaffirmed its path to full-year net income profitability. The commercial engine remains solid, with the company strategically pivoting its sales focus toward high-growth assets while letting GAVRETO stabilize at a steady $9.6 million per quarter.

Beyond the core business, Rigel is actively reshaping its portfolio and financing structure. The company terminated its collaboration with Eli Lilly for the RIPK1 inhibitor, a move that returns the asset to Rigel but signals a strategic retreat from immunology to double down on its hematology and oncology core. Meanwhile, the clinical pipeline remains the primary growth catalyst, with the R289 program in lower-risk MDS showing promising early efficacy and safety data. With top-line data expected by year-end, Rigel is positioning itself for a potential registration study in 2027, all while maintaining a fortress balance sheet and pursuing strategic in-licensing opportunities to fuel long-term expansion.

Key Takeaways

  • Q1 2026 net product sales reached $54.9 million, a 26% year-over-year increase, driven by strong commercial execution across the product portfolio.
  • TAVALISSE sales surged 31% to $37.3 million, benefiting from favorable gross-to-net dynamics and sustained demand despite seasonal reimbursement headwinds.
  • REZLIDHIA sales grew 31% to $8.0 million, with management highlighting a strategic push to improve community adoption through post-venetoclax efficacy data.
  • GAVRETO sales stabilized at $9.6 million, up 7% year-over-year, reflecting a mature product in a targeted RET-inhibitor market.
  • Management maintained full-year 2026 revenue guidance of $275 million to $290 million, including net product sales of $255 million to $265 million.
  • Rigel reported Q1 net income of $8.7 million, contributing to a full-year net income profitability target while funding pipeline advancements.
  • The R289 program in lower-risk MDS showed promising early results, with 33% of evaluable patients achieving transfusion independence lasting 8 weeks or longer.
  • Rigel terminated its collaboration with Eli Lilly for the RIPK1 inhibitor (ocadusertib), effectively returning the asset to Rigel as the company pivots away from immunology.
  • Management is actively pursuing late-stage in-licensing or acquisition opportunities in hematology and oncology to complement the existing commercial portfolio.
  • Rigel restructured its debt by replacing a $40 million term loan with a revolving credit facility, drawing down $8 million to maintain financial flexibility.

Full Transcript

Operator: Greetings. Welcome to Rigel Pharmaceuticals Financial Conference call for the first quarter 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 0 on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce our speaker, Ray Fury, Rigel’s Executive Vice President, General Counsel, and Corporate Secretary. Thank you. Mr. Fury, you may begin.

Ray Fury, Executive Vice President, General Counsel, and Corporate Secretary, Rigel Pharmaceuticals: Welcome to our first quarter 2026 financial results 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 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 December 31st and 2025 on file with the SEC and subsequent filings with the SEC, including the Q1 quarterly report on Form 10-Q with the SEC.

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.

Raul Rodriguez, President and Chief Executive Officer, Rigel Pharmaceuticals: 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. Beginning on slide 4, I will review our first quarter 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 the first quarter of 2026, we generated net product sales of just under $55 million, 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. 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. As a result, we are maintaining our 2026 revenue guidance for total revenues of $275 million-$290 million, including net product sales of $255 million-$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.

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 three commercial products, Camelys, REZLIDHIA, 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. 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. 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.

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 in 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 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.

We are focused on late-stage assets with potential commercial launches in the next three 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?

Dave Santos, Chief Commercial Officer, Rigel Pharmaceuticals: 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 the first quarter of 2026, continuing our trend of growing each quarter’s sales over the previous year, as evidenced by this slide. In the first quarter of 2026, we generated $54.9 million in U.S. net product sales, an increase of $11.3 million over Q1 of 2025, representing a 26% increase year-over-year. Our first quarter net sales were impacted by typical first quarter reimbursement dynamics, such as resetting of deductibles, co-pays, and other access delays for Medicare patients with plan changes that took effect in January.

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

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.

Moving to slide 12, we generated $3.9 million in revenues from collaborations in the 1st quarter, 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. In addition, our partners continued to pursue regulatory approvals for TAVALISSE in new markets. We continue to work on expanding access to our products in markets outside of the U.S. 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 for all potential indications throughout Dr. Reddy’s territories. These partners are now in the process of advancing REZLIDHIA in preparation for future potential regulatory submissions.

We are pleased that access to our products is expanding outside the U.S. With that, I’ll now pass the call over to Lisa to provide an update on our development pipeline. Lisa?

Lisa Rojkjaer, Chief Medical Officer, Rigel Pharmaceuticals: Thanks, Dave. I’ll now provide an update on our progress over the 1st quarter 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 I-B 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.

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 II 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.

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.

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 U.S. 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 effect came from a healthy volunteer study in which R835 markedly suppressed LPS-induced cytokine release compared to placebo.

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 I-B study, which was presented at ASH this past December. Now on slide 18, you can see the design of our multicenter open-label phase I-B study in patients with relapsed/refractory lower-risk MDS.

The phase I-B 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 II 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. I encourage you to review the corporate presentation in the investor section of our website, which includes the full dataset. 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 at 750 mg daily dose level, and no evidence of dose-dependent toxicity across the other dose groups. 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 milligrams 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. 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 II dose for future studies in the second half 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. Once the recommended phase II 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 I-B 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?

Dean Schorno, Chief Financial Officer, Rigel Pharmaceuticals: Thank you, Lisa. I’m on slide 22. We reported net product sales of $54.9 million for the first quarter, a growth of 26% year-over-year, including TAVALISSE net product sales of $37.3 million, a growth of 31% year-over-year. 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, chargebacks, rebates, returns, co-pay assistance, and other allowances of $20.5 million.

We also reported $3.9 million in contract revenues for the first quarter, primarily consisting of $1.8 million of revenue from Grifols related to earned royalties, $1.8 million of revenues from GISAID 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 the first quarter to $58.8 million. Moving to slide 23. For the first quarter 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.

The increase in costs 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 the first quarter 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 million-$290 million.

This includes our expectation of approximately $255 million-$265 million in net product sales and $20 million-$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 II study in adult patients with moderately to severely active rheumatoid arthritis. The termination will become effective on June 15, 2026. As a reminder, the CNS portion of the collaboration was previously terminated in November 2025.

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. 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. I’d like to turn the call back over to Raul. Raul?

Raul Rodriguez, President and Chief Executive Officer, Rigel Pharmaceuticals: 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. 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 4 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.

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 questions. Our first question comes from the line of Yigal Nochomovitz with Citigroup. Please proceed with your question.

Caroline, 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.

Raul Rodriguez, President and Chief Executive Officer, Rigel Pharmaceuticals: 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. 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. 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 with Lilly because the primary focus of RIPK1 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.

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 at our colleagues at Lilly over these years.

Caroline, Analyst, Citigroup: Thanks.

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

Joseph Pantginis, Analyst, H.C. Wainwright: Hey, 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, but with regard to growing the community centers, obviously it’s educating them in the post-ven setting, as you described. Are there any other drivers or key factors that are, I don’t wanna call it rate-limiting steps, but things that you feel need additional work?

Dave Santos, Chief Commercial Officer, Rigel Pharmaceuticals: I think, you’ve got it there, Joe. This is Dave, by the way. Sorry.

Joseph Pantginis, Analyst, H.C. Wainwright: Hi, Dave.

Dave Santos, Chief Commercial Officer, Rigel Pharmaceuticals: 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.

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.

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.

Joseph Pantginis, Analyst, H.C. Wainwright: That’s very helpful. Thank you very much. Maybe on R289, 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. 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?

Raul Rodriguez, President and Chief Executive Officer, Rigel Pharmaceuticals: Lisa, go ahead. If you would comment, Lisa, and I can add a comment after.

Lisa Rojkjaer, Chief Medical Officer, Rigel Pharmaceuticals: Okay, sure. Thanks for the question, Joseph. I think it’s a 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%-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.

I think that when we consider the difference in the patient populations, I think, you know, 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.

Raul Rodriguez, President and Chief Executive Officer, Rigel Pharmaceuticals: 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 proceed.

Joseph Pantginis, Analyst, H.C. Wainwright: Great. Appreciate the color.

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

Aya, Analyst, Cantor Fitzgerald: Hi, this is Aya on Kristen’s line. Thank you for taking her 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 II?

Raul Rodriguez, President and Chief Executive Officer, Rigel Pharmaceuticals: Lisa?

Lisa Rojkjaer, Chief Medical Officer, Rigel Pharmaceuticals: 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.

Raul Rodriguez, President and Chief Executive Officer, Rigel Pharmaceuticals: Thank you for the question.

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

Amin, Analyst, Jefferies: Hi, this is Amin on for Farzin. Thank you for taking our questions. A couple of questions from us. For GAVRETO revenue, it seems like that it’s plateauing in one Q. 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? I have a follow-up for R289.

Dave Santos, Chief Commercial Officer, Rigel Pharmaceuticals: If you wanna answer the GAVRETO revenue plateau in any color?

Yeah, listen, Amin, I’m sorry. I know you’re on for Farzin, but I didn’t catch your name. I’m sorry.

Amin, Analyst, Jefferies: That’s correct. Amin.

Dave Santos, Chief Commercial Officer, Rigel Pharmaceuticals: Okay. Sorry, Amin. 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.

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, some of our growth was 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.

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, that’s what we are doing with TAVALISSE and REZLIDHIA.

Amin, Analyst, Jefferies: Okay. Thank you.

Raul Rodriguez, President and Chief Executive Officer, Rigel Pharmaceuticals: Steve, do you have a 289 question as well?

Amin, 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?

Lisa Rojkjaer, Chief Medical Officer, Rigel Pharmaceuticals: 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.

Raul Rodriguez, President and Chief Executive Officer, Rigel Pharmaceuticals: 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 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.

Amin, Analyst, Jefferies: Okay, thanks.

Operator: Thank you.

Raul Rodriguez, President and Chief Executive Officer, Rigel Pharmaceuticals: Thank you.

Operator: If there are no further questions at this time, I’d like to turn the floor back over to Mr. Raul Rodriguez for closing comments.

Raul Rodriguez, President and Chief Executive Officer, Rigel Pharmaceuticals: 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 off 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.

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