Q1 2025 Rigel Pharmaceuticals Inc Earnings Call

In a listen only mode. A brief question and answer session will follow the formal presentation.

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It is now my pleasure to introduce our first speaker.

Ferry: <unk> theory, Rigel Executive Vice President General Counsel and corporate Secretary. Thank you. Mr. Ferry you may begin.

Greetings and welcome to Rigel Pharmaceuticals financial conference call for the first quarter 2025.

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.

Ferry: Welcome to our first quarter 2025 financial results and business update conference call. Our financial press release for the first quarter 2025 was issued a short while ago and can be viewed along with the slides for this presentation and the news and events section of our Investor Relations site on <unk> Dot com.

Speaker Change: It is now my pleasure to introduce our first speaker, Ray Furey, Rigel's Executive Vice President, General Counsel, and Corporate Secretary. Thank you, Mr. Furey, you may begin.

Lisa Rojkjaer: 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 being currently evaluated in the clinic, is the oral pro-drug that is rapidly converted to R835 in the gut. As I mentioned, R289 has both FDA Fast-Track and Orphan Drug designations, giving the molecule an expedited regulatory pathway, potential priority review, and seven years of market exclusivity upon approval. Both of these designations underscore the agency's interest in this rare disease and their willingness to collaborate with Rigel in the development of R289.

Ferry: As a reminder, during today's call we may make forward looking statements regarding our financial outlook.

Ferry: Our plans and timing for regulatory and 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 on Form 10-K for the year ended December 31, 2024 and subsea.

Speaker Change: Welcome to our first quarter 2025 financial results and business update conference call. The financial press release for the first quarter 2025 was issued a short while ago and can be viewed along with the slides for this presentation in the news and event section of our investor relationship site on Raul.com.

Ferry: <unk> filings with the SEC.

Ferry: Our quarter, one quarterly report on Form 10-Q on file with the SEC.

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

Ferry: 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 would like to turn the call over to our President and Chief Executive Officer Rahul countries.

Lisa Rojkjaer: In addition, R289 has thus far demonstrated a promising preliminary clinical profile in a Phase 1b study. The initial dose escalation data that were recently presented at the ASH annual meeting demonstrated promising preliminary safety and clinical activity in elderly, heavily pretreated patients with relapsed or refractory lower risk MDS.

Speaker Change: A description of these risks can be found in our most recent annual report on form 10K for the year end of December 31st, 2024, and subsequent findings with the SEC, including our quarter one, order report on form 10Q on file of the SEC.

Rahul countries: Thank you Ray and thank you everyone for joining today also with US today are David Santos, our Chief commercial officer.

Rahul countries: So ROIC here, our chief Medical Officer, and ensure our Chief financial Officer.

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

Rahul countries: Beginning on slide four we will provide an overview of rifles business and our results for the first quarter of 2025.

Lisa Rojkjaer: On slide 15, we outline 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. Aside from transfusions, initial therapies include erythropoiesis stimulating agents, or ESAs, if patients are eligible, and loose powder sets. A metal stat was also approved last year for ESA failure, high transfusion burden, lower risk MDS. With 8-week transfusion independence rates approaching 40% with Lispatercept and Imetelstat, many patients require an alternative treatment option.

Rahul countries: Yes.

Rahul countries: I want to start the call today by highlighting our strong start to the year today for the first quarter of 2025, we reported year over year net product sales growth of 68% from our expanding commercial portfolio.

Speaker Change: At this time, I would like to turn the call over to a president and she would take the voucher Raul Rodriguez, Raul.

Speaker Change: Thank you, Ray, and thank you everyone for joining today. Also with us today are Dave Santos, our Chief Commercial Officer, Lisa Rojkjaer, our Chief Medical Officer, and Dean Schorno, our Chief Financial Officer.

Rahul countries: In addition, we increased collaboration revenue from our ex U S marketing partners.

Rahul countries: With total revenue of $53 3 million for the quarter and continued financial discipline, we were able to generate $11 4 million and net income this quarter.

Speaker Change: Now, beginning on slide four, we will provide an overview of Raul's business and our results for the first quarter of 2025.

Speaker Change: I want to start the call today by highlighting our strong start to the year. Today for the first quarter of 2025, we reported year-over-year net product sales growth of 68% from our expanding commercial portfolio.

Rahul countries: Now this is a time when the general business environment is challenging, especially for the biotech market, but highlights the robustness of our corporate strategy and consequent sea. Consequently, our unique position.

Roger: Roger always a growing profitable company with important clinical opportunities at hand that we are able to fund ourselves.

Speaker Change: In addition, we increased collaboration revenue from our XUS marketing partners With total revenue of 53.3 million for the quarter and continued financial discipline, we were able to generate 11.4 million in net income this quarter

Speaker Change: On this call the team will provide you with greater details on our position and this quarter's results.

Lisa Rojkjaer: Although hypomethylating agents, or HMAs, are approved, the percentage of patients achieving transfusion independence is low.

Speaker Change: Dave will provide an overview update on the strength of our growing commercial business that now includes three commercial products. After the acquisition of our latest product that Brito.

Speaker Change: Now, this is the time when the general business environment is challenging, especially for the biotech market. But highlights the robustness of our corporate strategy and consequently our unique position.

Lisa Rojkjaer: Therefore, there's a high unmet need for safe, effective treatment options following failure of approved therapies, particularly for previously treated transfusion-dependent patients.

Speaker Change: Lisa will provide updates on the advancement of our development pipeline, including our 289, our novel and selective dual Iraq, one and four inhibitor.

Lisa Rojkjaer: On slide 16, you'll see the design of our ongoing open-label dose-escalation, dose-expansion Phase 1b study in relapsed refractory lower-risk MDS patients with either symptomatic anemia or transfusion-dependent. Primary endpoints are safety and selection of the recommended phase 2 dose. And secondary endpoints include transfusion independence, hemologic improvement, response rates, and PK. Enrollment is ongoing into dose level 6 in the dose escalation part of the study, evaluating a dose of 500 mg twice daily. Once enrollment of this cohort is complete, the plan is to select two doses to be compared head-to-head in the dose expansion part of the study to optimize selection of the recommended phase 2 dose for further evaluation.

Speaker Change: Rigel is a growing, profitable company with important clinical opportunities at hand that we are able to fund ourselves.

Speaker Change: Our 2009 is currently being evaluated in a phase <unk> clinical study in patients with relapsed or refractory lower risk Mds. She will also highlight our plans to expand or Lewis sitting there in a planned initial with the planned initiation of a phase II study in recurrent glioma.

Speaker Change: On this call, the team will provide you with greater details on our position and this quarter's results.

Speaker Change: They will provide an overview update on the strength of our growing commercial business that now includes three commercial products after the acquisition of our latest product,

Speaker Change: Beyond these rigel that development programs. We also remain committed to evaluating new opportunities to expand our hematology and oncology portfolio through business development as.

Speaker Change: Lisa will provide updates on the Advancement of our Development Pipeline, including R289, our novel and selective dual direct one and for interpreter.

Speaker Change: As we did with words, Lydia and get Red Oak.

Lisa: R2-9 is currently being evaluated in a Phase I B clinical study and patients with relapse or refractory lower risk MDS. She will also highlight our plans to expand Uludas Idnib in a planned initiation of a Phase II study in recurrent glioma.

Speaker Change: In 2025, we will continue to focus on commercial growth, while maintaining the financial discipline that has contributed to the results today and updates today.

Speaker Change: We continue to anticipate total we.

Speaker Change: We continue to anticipate 2025 total revenue of $200 million to $210 million and to report net positive net income for the full year 2025, while advancing and expanding our development pipeline.

Lisa Rojkjaer: In addition, once the recommended phase 2 dose has been determined, an exploratory cohort of first-line lower-risk MDS patients will be opened to evaluate R289 at that dose in an earlier line of therapy.

Lisa: Beyond these Rigel development programs, we also remain committed to evaluating new opportunities to expand our hematology and oncology portfolio through business development as we do with

Speaker Change: This is a testament to the strength of our business and the execution of our corporate strategy to grow our hematology and oncology business.

Lisa Rojkjaer: Initial data from the study was presented at ASH in late 2024. On slide 17, you'll see the initial safety data that was presented. To put the safety data into context, this was an elderly, heavily pretreated patient population with a median age of 76, more than 70% of whom had received either loose powder cept or an HMA. Almost three-quarters had a high transfusion burden, meaning they frequently received red cell transfusions before they enrolled in the study. In this population, R289 was generally well-tolerated with low-grade nausea, diarrhea, fatigue, chills, and pruritus being most frequently reported overall. Nausea and diarrhea were also two of the most frequently reported related adverse events that are indicated in the table on the slide.

Lisa: In 2025, we will continue to focus on commercial growth while maintaining that financial discipline that has contributed to the results today and updates today.

Speaker Change: Now before I turn the call over to Dave I want to take a moment to discuss our rent Colliers one inhibitor program that is partnered with Lilly.

Lisa: We've considered to anticipate 2025 total revenue of 200 to 210 million and to report positive net income for the full year 2025 while advancing and expanding our development pipeline.

Dave Brito: Last week, we notified literally that we will not exercise our right to share in future development expenses for our new sorts of known previously as rifles are 552.

Dave Brito: This incremental development cost sharing which we believe could be substantial and near term credit resulted in slightly higher royalty rates for rigel unmet cheap on future net sales.

Lisa: This is a testament to the strength of our business and the execution of our corporate strategy to grow our hematology and oncology business

Speaker Change: Now, before I turn the call over to Dave, I want to take a moment to discuss our rib caillous one inhibitor program that is partnered with Lily.

Dave Brito: While we continue to be very excited about the potential of book under certain we can we have concluded that it is optimal for us to invest our own and our own internal pipeline assets, such as our 289 and it'll get us and them.

Speaker Change: Last week, we notified Lily that we will not exercise our right to share in future development expenses for our

Lisa Rojkjaer: Overall, the most frequently reported grade 3 or 4 adverse events were anemia, decreased platelet count, pneumonia, and increased ALT, occurring in only two patients each. So thus far, what we're not seeing is a high incidence of cytopenias and infections, which is encouraging.

Dave Brito: Dean will tell you a bit more about the financial impact of this in his remarks.

Speaker Change: This incremental development cost share, which we believe could be substantial and near-term, could have resulted in slightly higher royalty rates for Rigel on future net sales.

Dave Brito: With that I'll turn the call over to Dave to provide a commercial update.

Dave Brito: Thank you Ralph.

Dave Brito: On slide six you'll see our three commercial products top of lease give red oak and risks lithium.

Speaker Change: While we continue to be very excited about the potential of Oc under certain, we have concluded that it is optimal for us to invest our own and our own internal pipeline assets, such as R289 and Oludis in them.

Lisa Rojkjaer: On slide 18, we show the preliminary efficacy data. The swimmer plot shows each patient and the red cell transfusions by dose group, starting with the lowest dose group, 250 mg daily, on top. For the IWG 2018 criteria, the transfusion history for each patient was collected for 16 weeks prior to R289 administration to establish the baseline transfusion frequency for each patient, shown to the left of Day 0, which is indicated by the red arrow. 18 patients were valuable for efficacy, meaning that they had received one or more R289 doses and had at least one efficacy assessment.

Dave Brito: Turning to slide seven we are pleased with the strong year over year growth in revenues in the first quarter of 2025.

Dave Brito: You can see how our quarterly and annual sales of increase since 2021 in the chart.

Speaker Change: Dean will tell you a bit more about the financial impact of this and his remarks Now with that, I'll turn the call over to Dave to provide a commercial update.

Dave Brito: We have credit each quarter sales over the previous year and that growth continues in.

Dave Brito: In the first quarter of 2024, we reported $26 million and now for the first quarter of 2025, we generated $43 $6 billion, representing a 68% increase.

Dave: Thank you, Raul. On slide 6, you'll see our three commercial products,

Dave: Fimming to slide 7, we are pleased with the strong, year-over-year growth in revenues in the first quarter of 2025.

Dave Brito: Our year over year growth was driven by the addition of GAAP rent owed to our portfolio last year as well as growth in both top of lease and rest Lydia.

Dave: You can see how our quarterly and annual sales have increased since 2021 in the chart.

Lisa Rojkjaer: Red blood cell transfusion independence lasting eight weeks or longer was achieved by three patients, one receiving 500 mg daily and two receiving 750 mg daily. Red blood cell transfusion independence lasted for more than 6 months in 2 patients, and 1 patient also achieved a marrow complete response. The median duration of transfusion independence was 29 weeks. In addition, one high transfusion burden patient receiving 500 milligrams daily achieved a minor HIE response with a 64% reduction in red cell transfusions compared to baseline. Looking at PK, we noticed that at R289 doses of 500 milligrams once daily and higher, R835 plasma concentrations reached or exceeded those correlating with 50% or 90% LPS-induced cytokine inhibition that was previously observed in healthy volunteers.

Dave: We have grown each quarter sales over the previous year and that growth continues.

Dave Brito: Our commercial team has been dedicated to execution driving continued momentum fotopoulos, raising awareness forget brown, who after a successful transition into our portfolio.

Dave: In the first quarter of 2024, we reported $26 million, and now for the first quarter of 2025, we generated $43.6 million, representing a 68% increase.

Dave Brito: And improving both institutional and community demand Forest Lydia.

Dave Brito: My sincere thanks to the entire team for all their hard work.

Dave: Our year-over-year growth was driven by the addition of Devreto to our portfolio last year, as well as growth in both Tobalice and Restlidia.

Dave Brito: Slide eight shows a summary of our commercial performance byproduct.

Dave Brito: First on top of lease I'm pleased to report another strong quarter in which we generated $28 $5 million and net product sales an increase of 35% compared to the first quarter of 2024.

Dave: Our commercial team has been dedicated to execution, driving continued momentum for Tobalice, raising awareness for Devreto after a successful transition into our portfolio, and improving both institutional and community demand for Estlidia.

Dave Brito: This growth was driven by continued strong patient demand with another consecutive quarterly record high.

Dave: Myson, see your thanks to the entire team for all their hard work.

Dave Brito: Okay, Brito, we delivered $9 million and net product sales in Q1.

Dave: Flight 8 shows the summary of our commercial performance by product.

Dave Brito: As a reminder, <unk> became commercially available from Rachel in late June 2024.

Lisa Rojkjaer: And what's interesting is that at these doses, i.e. 500 and 750 milligrams once daily, 40% or 4 out of 10 valuable transfusion-dependent patients achieve transfusion independence.

Dave: First on Tavillice, I'm pleased to report another strong quarter in which we generated $28.5 million in net product sales, an increase of 35% compared to the first quarter of 2024.

Dave Brito: And lastly for risks Lithia, we reported $6 1 million and net product sales, an increase of 25% compared to the prior year period.

Dave: This growth was driven by continued strong patient demand, with another consecutive quarterly record high.

Lisa Rojkjaer: Moving to slide 19, you see the summary of the responding patients. A few things to highlight here. The majority of responding patients were high transfusion burden at baseline and had received a variety of prior therapies, including Lispatercept, isomethylating agents, and even some experimental therapies. Both patients achieving durable transfusion independence lasting more than six months, patients four and ten, were high transfusion burden at baseline and had received HMAs. Beneath the table, we see the hemoglobin levels over time for the three patients that became transfusion-free. Although patient 10 in the middle eventually lost their response following a drug interruption and dose reduction, on the background of transfusion independence, peak hemoglobin increases ranging from 2.3 to 5.6 grams per deciliter compared to baseline were observed, indicating that R289 has the potential to correct anemia, providing support for its evaluation earlier in treatment.

Dave Brito: Moving to slide nine I'll provide more color on our commercial performance.

Dave: For Gavretto, we delivered $9 million in net product sales in Keywood. As a reminder, Gavretto became commercially available from Rigel in late June 2024.

Dave Brito: I believe it continues to grow steadily as the foundation of our portfolio.

Dave Brito: Insistently, hitting new record quarterly high patient demand.

Dave Brito: That steady growth has been driven by new patient starting on top of weeks each quarter and the subsequent increased carryover that's generated.

Dave: And lastly, for Res Lydia, we reported $6.1 million in that product sales, an increase of 25% compared to the prior year period.

Dave Brito: We expect this trend to continue throughout 2025.

Dave: Moving to Slide 9, I'll provide more color on our commercial performance.

Dave Brito: In addition in the first quarter, we completed a successful streamlining of our distribution network to improve efficiency and be consistent across the entire portfolio.

Dave Brito: <unk> continued to grow nicely under our ownership.

Dave: That steady growth has been driven by new patients starting on top of a lease each quarter and the subsequent increased carryover that's generated.

Dave Brito: In the first quarter of 2025, the third full quarter of that Red oak being in the portfolio, we generated $9 million in revenue approximately 15% year over year growth compared to the first quarter of 2024.

We expect this trend to continue throughout 2025.

Lisa Rojkjaer: In summary, the initial data is encouraging, showing R289 is generally well-tolerated with promising signs of preliminary activity in heavily pretreated transfusion-dependent patients.

Dave: In addition, in the first quarter, we completed a successful streamlining of our distribution network to improve efficiency and be consistent across the entire portfolio.

Dave Brito: Recorded by the previous owner of the product.

Dave Brito: On a sequential basis, we saw 11% revenue growth versus Q4 of 2024, driven by additional carryover from existing patients as well as new patients.

Lisa Rojkjaer: We look forward to sharing additional data from the study in the second half of this year.

Gavretto continued to grow nicely under our ownership.

Lisa Rojkjaer: Now we'll shift focus to elutucidinib, our IDH1 inhibitor.

Dave: In the first quarter of 2025, the third full quarter of Devredo being in the portfolio, we generated $9 million in revenue, approximately 15% year-over-year growth, compared to the first quarter of 2024, as reported by the previous owner of the product.

Dave Brito: The seamless transition into our portfolio as provided a solid platform for growth that we will continue to build on.

Lisa Rojkjaer: Beginning on slide 21, glioma is an area that is incredibly challenging where there's not been much advancement in therapeutic options. Diffuse gliomas are the most common primary brain tumor in adults, affecting approximately 20,000 in the U.S. each year. IDH1 mutations occur in about 70% of patients with grade 2 and 3 glioma, and are found in up to almost 35% of adolescent and young adult patients. Unfortunately, most of disease recurs and there is no standard of care therapy for relapsed patients. The recent approval of voracidinib, an IDH1 and 2 inhibitor, in grade 2 low-grade gliomas has highlighted the potential for IDH inhibitors in glioma.

Dave Brito: We're confident we can continue to grow caporetto as we begin more targeted efforts on expanding our base of prescribers, particularly since the use of ret inhibitors in non small cell lung cancer.

Dave: On a sequential basis, we saw 11% revenue growth versus Q4 of 2024 driven by additional carry-over from existing patients as well as new patients.

Dave Brito: Can you expand in the frontline setting.

Dave Brito: System with the updated guidelines I discussed last quarter.

Dave Brito: Overall, we believe that ret inhibitor use will continue to grow beyond 2025, and give rental will grow in turn.

Dave: The seamless transition into our portfolio has provided a solid platform for growth that we will continue to build on.

Dave: We are confident we can continue to grow vibrato as we begin more targeted efforts on expanding our base of prescribers.

Dave Brito: Well Ross linear we continue to drive new patient starts as we raise awareness for the product and especially as clinicians become more aware of <unk> efficacy in post phonetic lacks patients.

Lisa Rojkjaer: Eleuticidinib was previously evaluated in the Phase 1B2 study in 26 patients, which was previously published in the journal Neuro-Oncology. Two patients with high-grade glioma achieved partial responses and both with enhancing tumors. And 10 patients achieved stable disease, for a disease control rate of 48%. This clinical proof of concept supports further evaluation of lutecidinib and glioma.

Dave Brito: They believe that activity is clinically meaningful as these patients are very difficult to treat with other therapies.

Dave: Overall, we believe that Retinhibitor Use will continue to grow beyond 2025 and give Retin will grow in turn.

Dave Brito: We are also focused on educating health care professionals on the benefits of patients remaining on therapy.

Dave: For Res Lydia, we continue to drive new patients' starts as we raise awareness for the product, and especially as clinicians become more aware of Res Lydia's efficacy in post-finetaclax patients.

Dave Brito: Insistent with data that was presented at the Ash meeting in December.

Lisa Rojkjaer: Moving to slide 22, we outline our development approach in glioma.

Dave Brito: The analysis showed that while some patients with mutant 90, H, one relapsed or refractory AML achieve responses very quickly sometimes within one to two months of treatment.

Lisa Rojkjaer: Last year, we entered a collaboration with the global neuro-oncology consortium, CONNECT. In CONNECT's TARGET trial, a molecularly guided phase 2 umbrella clinical trial for high-grade glioma, the Rigel-sponsored arm of the study, TARGET-D, will evaluate a post-radiotherapy maintenance regimen of elutocidinib in combination with temozolomide, followed by elutocidinib monotherapy in newly diagnosed patients between 12 and 39 years of age with IDH1 mutation-positive high-grade glioma. This study is open for enrollment.

Dave: They believe that activity is clinically meaningful, as these patients are very difficult to treat with other therapies.

Dave Brito: For patients, who continued treatment with breasts linear require up to six months to achieve CR CRH and even up to 10 months for an overall response.

Dave: We are also focused on educating healthcare professionals on the benefits of patients remaining on therapy.

Dave Brito: This data supports the prescribing information that suggest treating patients for at least six months to allow time for clinical response in patients without disease progression or unacceptable toxicity.

Dave: Consistent with data that was presented at the ash meeting in December .

Dave: The analysis showed that while some patients with mutant IDH1 relapse to refractory AML, achieve responses very quickly, sometimes within one to two months of treatment.

Dave Brito: We believe we still have a significant opportunity to grow whereas <unk> is used in mute 90, H, one relapsed or refractory acute myeloid leukemia, and we are focused on building on the scientific data currently available in this important population of AML pictures.

Lisa Rojkjaer: In addition, we're on track to initiate a Phase II clinical study in recurrent glioma later this year. We think this is an important opportunity as there is a significant unmet need in this patient population. We, along with Connect, are excited about elutacidin's potential to provide a much-needed new treatment option to this underserved patient population, and we look forward to the data generation from the Connect study in addition to our planned study in recurrent glioma.

Dave: This data supports the prescribing information that suggests treating patients for at least six months to allow time for clinical response in patients without disease progression or unacceptable toxicities.

Dave Brito: Finally, moving to slide 10, we continue to work on expanding access to our products in markets outside of the U S.

Dave Brito: <unk> is commercially available in Japan in Europe under the brand name to have less and in Canada, and Israel via our partners, He say cripples and Medisoft.

Speaker Change: We believe we still have a significant opportunity to grow as Lidia's use in mutant IDH1 relapse or refractory acute myeloid leukemia, and we are focused on building on the scientific data currently available in this important population of AML pinchers.

Lisa Rojkjaer: On slide 23, you'll see another important collaboration, our strategic alliance with the MD Anderson Cancer Center to advance elutacidin more broadly into AML, MDS, and beyond. All four studies included in this collaboration are open for enrollment and we look forward to sharing updates from this collaboration in the future.

Dave Brito: In addition, our partners continue to pursue regulatory approvals for <unk> in new markets late last year, not therapeutics announced it had received regulatory approval for <unk> in Mexico and in January He say announced regulatory approval for <unk> in the Republic of Korea.

Speaker Change: Finally, living to slide 10, we continue to work on expanding access to our products in markets outside of the US.

Raul Rodriguez: turning to our partnered program. On slide 25, as Raul mentioned, we're very excited about the Lilly collaboration for Okadusertib and the CNS Penetrant Program. The RIFK1 inhibitor programs are progressing well with our partner Lily, and we're very pleased with the program's potential. RIKK1 is implicated in a broad range of inflammatory cellular processes and plays a key role in TNF signaling. Ocaducertibs, the non-CNS penetrant RIKK1 inhibitor, previously referred to as R552, is currently being studied in an adaptive Phase 2a, 2b clinical trial in up to 380 patients with active moderate to severe rheumatoid arthritis. Phase 2a enrollment is advancing well.

Speaker Change: Tobalese is commercially available in Japan, in Europe under the brand name Tavles, and in Canada and Israel, VR Partners, Kisei, Griffels, and Medeson.

For us its linear in 2024, we expanded our relationship with <unk> to include Japan, The Republic of Korea, and Taiwan for all potential indications and we entered into an exclusive license agreement with Doctor Readies for all potential indications throughout Doctor Readies territory.

Speaker Change: In addition, our partners continue to pursue regulatory approvals for Tobalice in new markets.

Speaker Change: Late last year, NYT therapeutic announced it had received regulatory approval for Tava-Lease in Mexico, and in January , Kise announced regulatory approval for Tava-Lease in the Republic of Korea.

Dave Brito: Which includes Latin America and other territories.

Dave Brito: We are pleased that access to our products is expanding outside the U S and we continue to explore other opportunities for partnerships outside the U S to bring our partner our products to other patients and markets around the globe.

Speaker Change: For Res Lydia, in 2024, we expanded our relationship with Kisei to include Japan.

Speaker Change: The Republic of Korea and Taiwan for all potential indications and we entered into an exclusive license agreement with Dr. Reddys for all potential indications throughout Dr. Reddys territory, which includes Latin America and other territories.

Dave Brito: I will now pass the call over to Lisa to provide an update on our development pipeline Lisa.

Raul Rodriguez: The preclinical CNS penetrant RIPK1 inhibitor program is also progressing toward lead candidate nomination.

Lisa: Thanks, Dave I'll now provide an overview of our pipeline progress and plans for the remainder of the year.

Raul Rodriguez: Moving to slide 26, we outlined several upcoming milestones for our development programs in 2025. For our ongoing R289 program and lower-risk MDS, we expect to complete the dose escalation part of the Phase 1b study. We then plan to initiate the dose expansion phase later this year. Also, during the year, we plan to seek health authority input on the registrational path for R289. And we're anticipating presenting updated dose escalation data in the second half of the year. Then, for lutasidinib, we plan to initiate a Phase II clinical study in recurrent glioma by year-end. We'll provide you with more details about that study later this year.

Lisa: On slide 12 from our development pipeline, we are particularly excited by the progress in the clinical development of our 289, our novel dual Iraq, one direct four inhibitor and lower risk Myelodysplastic syndrome, or Mds and Duluth is sudden mutant I D. H one rig currently OMA.

Speaker Change: We are pleased that access to our products is expanding outside the U.S., and we continue to explore other opportunities for partnerships outside the U.S. to bring our products to other patients and markets around the globe.

Speaker Change: I will now pass a call over to Lisa to provide an update on our development pipeline. Lisa?

Lisa: With our 289, our phase <unk> study in patients with relapsed refractory lower risk Mds is progressing well and we're currently enrolling dose level six we look forward to providing updated data from this study in the second half of this year.

Lisa: Next days, I'll now provide an overview of our pipeline progress and plans for the remainder of the year.

I'm on slide 12.

Speaker Change: From our development pipeline, we're particularly excited by the progress in the clinical development of R289. Our novel dual IRAC-1 and IRAC-4 inhibitor in lower risk milder dysplastic syndrome, or MDS, and eluticinib mutant IDH-1 recurrent glioma.

Lisa: From a regulatory perspective, the granting of both fast track designation for the treatment of patients with previously treated in transfusion dependent lower risk Mds and orphan drug designation for Mds is an acknowledgment by the FDA of both the unmet medical need of the lower risk Mds patient population and the potential of Archie.

Raul Rodriguez: In addition, we'll continue to support the four M.D. Anderson studies and the Connect We're excited about the potential of our development programs and look forward to providing updates in the future.

Speaker Change: Beginning with R289, our Phase 1B study in patients with relapsed refractory lower risk MDS is progressing well and we're currently enrolling dose level 6. We look forward to providing updated data from this study in the second half of this year.

Dean Schorno: Now we'll pass the call to Dean to discuss our financial results for the quarter. Dean? Thank you, Lisa. I'm on slide number 28. We reported net product sales of $43.6 million for the first quarter, growth of 68% year over year, including Tavolis net product sales of $28.5 million, a growth of 35% year over year. Gavretto net product sales of $9 million.

Lisa: Not.

Lisa: Furthermore, as part of Rigel sponsored development programs and alongside our partners MD Anderson and the connects cancer consortium.

Lisa: Just sitting there that's being evaluated in new indications, we believe will interest sitting up has potential in several cancers, where mutated I D. H one plays a role such as glioma. Additionally, in all segments and Mds, either as monotherapy or in combination.

Speaker Change: From a regulatory perspective, the granting of both fast track designation for the treatment of patients was previously treated transfusion-dependent lower risk MDS and orphan drug designation for MDS.

Speaker Change: It's an acknowledgement by the FDA of both the unmet medical need of the lower risk MDS patient population and the potential of R289.

Dean Schorno: As a reminder, Gavretto became available for Rigel in June of 2024. And we reported Resilidia net product sales of $6.1 million, a growth of 25% year over year. Our net product sales from Tavolis, Gabaretto, and Roselidia were recorded net of estimated discounts, chargebacks, rebates, returns, copay assistance, and other allowances of $16.6 million. As anticipated, we saw a sequential decrease in net product sales from the fourth quarter of 2024. Consistent with our remarks on our fourth quarter earnings call and what we've seen in past first quarters, our revenues were impacted by a drawdown in inventory levels across our distribution channels.

Lisa: We expect to initiate a rigel sponsored phase two study to evaluate the looser sitting there that we're currently on that later this year.

Lisa: In addition, all forward clinical trials under our MD Anderson collaboration are now open for enrollment as is the target <unk> study evaluating the combination of electricity was 10 months old alive as maintenance therapy in adolescents and young adults with I D. H, one mutated high grade glioma.

Speaker Change: We believe elitistinab has potential in several cancers where mutated IDH1 plays a role, such as guilloma, additional AML segments, and MDF, either as monotherapy or in combination.

Consistent with our strategy and evidenced by our acquisitions of the looser sitting that and proud setting that we remain focused on evaluating potential opportunities to expand our portfolio by in licensing or acquiring products that would be a strategic fit for hematology and oncology focus.

Speaker Change: We expect to initiate a Rigel sponsor's Phase II study to evaluate the Lucicinibin recurrent

Speaker Change: In addition, all four clinical trials under our MD Anderson collaboration are now open for enrollment.

Dean Schorno: We also reported $9.8 million in contract revenues from our collaborators for the first quarter. Primarily driven by contributions from Riffles, TSA, which included the $3 million milestone payment, and MediSign, bringing our total revenues for the first quarter to $53.3 million.

Speaker Change: As is the connect target D study evaluating the combination of eluticidness with temizolamide as maintenance therapy and adolescents and young adults with IDH1 mutated hygric glioma.

Lisa: Now I'll spend a few moments on our 289 program.

Lisa: I'm now on slide 14, which presents an overview of the value proposition of our 289 in lower risk Mds.

Speaker Change: Consistent with strategy and evidence by our acquisitions of eluticid and proud set in them, we remain focused on evaluating potential opportunities to expand our portfolio by in licensing or acquiring products that would be a strategic set for our hematology and oncology focus.

Lisa: There are about 12000 previously treated lower risk Mds patients in the U S. With recent development efforts and lower risk Mds, focusing primarily on first line therapies, there's a high unmet need for next line therapies, particularly for previously treated transfusion dependent patients.

Dean Schorno: Finally, I'd like to take a moment to discuss the reporting impact from our notification to Lilly that we will not exercise our opt-in right related to the development and commercialization of OCAD Dissertive for the treatment of non-CNS diseases. As a result of this notification, in the second quarter, we expect to recognize approximately $40 million in collaboration revenue. This is non-cash and related to the release of the remaining cost share liability currently on our balance sheet. Under the terms of our collaboration agreement, Roger will continue to be entitled to receive milestone and tiered royalty payments of future net sales.

Now we'll spend a few moments on our R289 program.

Lisa: This regulation of inflammatory signaling is key to the pathogenesis of lower risk Mds and Iraq, one in four mediate this process.

Speaker Change: I'm now on slide 14, which presents an overview of the value proposition of R289 and lower risk MDS.

Speaker Change: There are about 12,000 previously treated lower risk MDS patients in the U.S.

Lisa: Looking both Iraq, one in four may suppress Maryland, inflammation, and leukemic stem and progenitor cell function and restore hematopoiesis.

Speaker Change: With recent development efforts in lower risk MDS focusing primarily on first-line therapies, there's a high unmet need for next-line therapies, particularly for previously treated transfusion-dependent patients.

Lisa: Our 835, the active moiety of article eight nine flux toll like receptor and IL one receptor signaling in vitro and was active in various preclinical models of inflammation.

Dean Schorno: Moving on to the next slide, endowment income statement and cost and expense. Our cost of product sales were approximately $4.4 million for the first quarter of 2025. Total cost and expenses were $40.6 million compared to $36.5 million for the same period of 2024. The increase in costs and expenses was mainly due to increased personnel-related costs and higher R&D costs driven by the timing of clinical activities related to R289 and lutecidinib. In addition, cost of product sales increased driven by increased product sales, higher royalties, and amortization of intangible assets. These increases were partially offset by decreased stock-based compensation expense.

Speaker Change: This regulation of inflammatory signaling is key to the pathogenesis of lower risk MDS and IRAC-1 and 4, mediate this process.

Lisa: Cynical proof of concept that this anti inflammatory effects came from a healthy volunteer study in which Ari three fives markedly suppressed L. P. S induced cytokine release compared to placebo.

Speaker Change: Blocking both Ira Q1 and 4 may suppress marrow inflammation and the chemics stem and progenitor cell function and restore metal pleases.

Lisa: As a reminder, our 289, which is being currently evaluated in the clinic is the oral pro drug that is rapidly converted to our 835 in the gut.

Speaker Change: R-835, the active moiety of R-289, flux, toll-like receptor, an IL-1 receptor signaling, and vitro, and was active in various preclinical models of inflammation.

Lisa: As I mentioned, our 289 has both FDA fast track and orphan drug designations, giving the molecule an expedited regulatory pathway potential priority review and seven years of market exclusivity upon approval.

Speaker Change: Clinical proof of concept of this anti-inflammatory effect came from a healthy volunteer study in which RA-35s markedly suppressed LPSMD cytokine release compared to placebo.

Dean Schorno: We reported net income of $11.4 million for the first quarter compared to a net loss of $8.2 million in the same period in 2024. We ended the quarter with cash, cash equivalents, and short-term investments of $77.1 million, similar to the $77.3 million as of the end of 2024.

Lisa: These designations underscore the agencies interested in this rare disease and their willingness to collaborate with fragile and the development of our two late night.

Speaker Change: As a reminder, R289, which is being currently evaluated in the clinic, is the oral pro-drug that is rapidly converted to R835 in the gut.

Lisa: In addition, our 289 has thus far have demonstrated a promising preliminary clinical profile in a phase one study.

Speaker Change: As I mentioned, R289 has both FDA fast-track and orphan drug designations, giving the molecule an expedited regulatory pathway, potential priority review, and seven years of market exclusivity upon approval.

Lisa: Initial dose escalation data that were recently presented at the Ash annual meeting demonstrated promising preliminary safety and clinical activity and elderly heavily pretreated patients with relapsed or refractory lower risk Mds.

Dean Schorno: Before I discuss our financial outlook for 2025, I wanted to spend a moment discussing potential tariffs to Rigel as a result of global trade tensions. Roger uses a group of typical third-party contract manufacturers for API and finished goods manufacturing, some of which are located outside the U.S. Given the uncertainty, we're not prepared to provide an expected impact of potential tariffs today. We do expect any impact to be modest, and note that our IP is domiciled in the U.S.

Speaker Change: Both of these designations underscore the agency's interest in the rare disease and their willingness to collaborate with Rigel in the development of R289.

Lisa: On slide 15, we outline the treatment landscape for the lower risk Mds.

Speaker Change: In addition, R289 has thus far demonstrated a promising preliminary clinical profile in a Phase-1D study.

Lisa: And the answer is a clonal disorder of hematopoietic stem cells, leading to dysplasia, and then affected a lot of polices.

Lisa: The main consequences for patients, our anemia, and transfusion dependence, which adversely impact the quality of life.

Speaker Change: The initial dose escalation data that were recently presented at the ASHA annual meeting demonstrated promising preliminary safety and clinical activity and elderly, heavily pre-treated patients with relapsed or refractory lower risk MDF.

Dean Schorno: Turning to our financial outlook for 2025, we continue to anticipate total revenue in the range of approximately $200 to $210 million. This includes our unchanged expectation of approximately $185 to $192 million in net product sales and $15 to $18 million of contract revenues from collaboration. In addition, we continue to anticipate reporting positive net income for the full year of 2025, while funding existing and new clinical development programs. Please note that our 2025 revenue guidance excludes the approximately $40 million in non-cash collaboration revenue that's expected to be recognized in the second quarter related to our Lilly Agreement.

Lisa: In addition infections iron overload from transfusions, and subsequent Oregon dysfunction, all negatively impacts the patient.

Lisa: Aside from transfusions initial therapies include erythropoiesis stimulating agents or Esa is patients are eligible and this pattern or sets of metals that was also approved last year for Esa failure high transfusion burden lower risk Mds.

Speaker Change: On slide 15, we outline the treatment landscape for lower risk MDS.

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

Lisa: With the eight week transfusion independence rates approaching 40%, which was patterson and the metals that many patients require an alternative treatment option.

Speaker Change: In addition, infections, iron overload from transfusions, and subsequent organ dysfunction, all negatively

Lisa: Although hyperventilating agents or hma's or approved the percentage of patients achieving transfusion independence is low there.

Speaker Change: Aside from transfusions, initial therapies include erythropolisis, stimulating agents, or ESAs, the patients are eligible, and this pattern sets. A metal stout was also approved last year for ESA failure, high transfusion burden, lower risk MDS.

Dean Schorno: To wrap up my section, we look forward to continued financial discipline for the remainder of 2025 and beyond.

Lisa: Therefore, there is a high unmet need for safe effective treatment options. Following failure of approved therapies, particularly for previously treated transfusion dependent patients.

Raul Rodriguez: With that, I'd like to turn the call back over to Raul.

Raul Rodriguez: Raul? Thank you, Dean. Moving on to slide 30, we made significant strides over the past three years to expand our commercial portfolio via licensing or acquiring assets that fit our commercial capabilities and portfolio focus. We have a proven track record of delivering top-line growth, as evidenced by the 32% compound annual growth rate, or CAGR, in revenue growth from 2021 to 2024. This revenue growth enables us to fund our business and our strategic priorities, including to continue expanding our hematology and oncology business. and we're confident in our expectation of approximately $185 to $192 million in net product sales.

Lisa: On slide 16, you'll see the design of our ongoing open label dose escalation dose expansion phase <unk> study in relapsed refractory lower risk Mds patients with either symptomatic anemia or transfusion dependence.

Speaker Change: With 8-week transfusion and dependence rates approaching 40% with whose patriceft in the metal stat, many patients require an alternative treatment option.

Speaker Change: Although hyper-methylating agents or HMAs are approved, the percentage of patients achieving transfusion independence is low.

Lisa: Primary endpoints are safety and selection of the recommended phase two dose and secondary endpoints include transfusion independence hematologic improvement response rates and P. K.

Speaker Change: Therefore, there's a high unmet need for safe, effective treatment options following failure of approved therapies, particularly for previously treated transfusion dependent patients.

Lisa: Enrollment is ongoing in two dose level six in the dose escalation part of the studies evaluating a dose of 500 milligrams twice daily.

Speaker Change: On slide 16, you'll see the design of our ongoing open-label dose escalation, dose expansion SAES-1B study, and relapse refractory lower-risk MDF patients with either symptomatic anemia or transfusion dependence.

Lisa: Once enrollment in this cohort is complete the plan is to select two doses to be compared head to head in the dose expansion part of the study to optimize selection of the recommended phase two dose for further evaluation.

Raul Rodriguez: Turning to slide 31. For the remainder of 2025, our priorities are clear. Grow our commercial business. advance our development pipeline, identify new pipeline opportunities, and continue to maintain financial discipline. We anticipate growing our net product sales in 2025 by approximately 30% year over year. We remain focused on advancing our Phase 1B clinical study, evaluating R289 for the treatment of patients with lower-risk MDS. And we are on track to publish updated data at a medical meeting late this year and initiate the dose expansion phase of this study by year-end. For Oluvizitinib, we plan to initiate a new, RIGEL-sponsored Phase II study in recurring glioma while continuing to support our strategic collaborations with both MD Anderson and the CONNECT organization.

Speaker Change: Primary endpoints are safety and selection of the recommended phase two dose and secondary endpoints include transfusion and dependence, hemrologic improvement, response rates, and PK.

Lisa: In addition, once the recommended phase two dose has been determined an exploratory cohort of first line lower risk Mds patients will be opened to evaluate our 289 at that dose in an earlier line of therapy.

Speaker Change: Enrollment is ongoing into dose level 6 in the dose escalation part of the study, evaluating a dose of 500 milligrams twice daily.

Lisa: Initial data from the study was presented at Ash in late 2024.

Speaker Change: Once enrollment of this cohort is complete, the plan is to select two doses to be compared head-to-head in the dose expansion part of the study to optimize selection of the recommended phase two dose for further evaluation.

Lisa: On slide 17, you'll see the initial safety data that was presented.

Lisa: The safety data into context. This was an elderly heavily pretreated patient population with a median age of 76 more than 70% of whom have received either this powder stuff or in HMA.

Speaker Change: In addition, once the recommended phase 2 dose has been determined, an exploratory cohort of first-line lower risk MDS patient will be opened to evaluate R289 at that dose in an earlier line of therapy.

Almost three quarters had a high transfusion burden, meaning they frequently received red cell transfusions before they enrolled in the study.

Raul Rodriguez: With our anticipated strong revenue growth, financial discipline in 2025, we will continue to invest in our development programs, but also expect to report positive net income for the full year. Finally, on slide 32, our successful execution of our corporate strategy has resulted in Rigel being uniquely positioned in building a leading hematology and oncology business in a profitable and sustainable manner.

Speaker Change: Initial data from the study was presented at Ash in late 2024.

Lisa: In this population are 289 was generally well tolerated with low grade nausea, diarrhea, fatigue, chills and pruritus being most frequently reported overall.

Speaker Change: To put the safety data into context. This was an elderly heavily pre treated patient population with a median age of 76 more than 70% of schools have received either loose powder subs for an HMA.

Lisa: Nausea, and diarrhea were also two of the most frequently reported related adverse events that are indicated in the table on the slide.

Speaker Change: Almost three quarters had a high transfusion burden, meaning they frequently received red cell transfusions before they enrolled in the study.

Lisa: Overall, the most frequently reported grade three or four adverse events, where anemia decreased platelet count pneumonia and increased L. T.

Raul Rodriguez: And with that, I'd like to thank you for your interest, and we will now open the call to your questions.

Speaker Change: In this population are 289 was generally well tolerated with low grade nausea, diarrhea, fatigue, chill and pruritus being most frequently reported overall.

Operator: Operator. Thank you. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. Please press star 2 if you would like to remove your question from the line. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start button. Once again, to ask a question, press star 1 on your telephone keypad. Stand by while we pull.

Lisa: And only two patients each.

Lisa: So thus far but we're not seeing is the high incidents of cytopenia send infections, which is encouraging.

Speaker Change: Nausea, and diarrhea were also two of the most frequently reported related adverse events that are indicated in the table on the slide.

Lisa: On slide 18, we show the preliminary efficacy data swim.

Lisa: A swimmer plot shows each patient and the red cell transfusions by dose group, starting with the lowest dose group 250 milligrams daily on top.

Speaker Change: Overall, the most frequently reported grade three or four adverse events, where anemia decreased platelet count pneumonia and increased L. T occurring in only two patients each.

Lisa: I thought we achieved 2018 criteria the transfusion history for each patient was collected for 16 weeks prior to our 289 administration to establish the baseline transfusion frequency for each patient shown to the left of days zero, which is indicated by the Red Arrow.

Speaker Change: So thus far we're not seeing is the high incidents cytopenia skin infections, which is encouraging.

Kalpit Patel: And now our first question comes. Kalpit Patel with B. Reilly Securities, please. Yeah. Hey, good afternoon and thanks for taking the question. I had one on the Target D program that you have ongoing in high-grade glioma. I guess you have two different plans here for glioma. You have that study running and then you also have the planned company-sponsored Phase II trial and recurrent glioma. Can you help us clarify the objectives and perhaps the design differences between the two? And longer term, what signals do you want to see in the Target D program to justify moving forward in one program or the other?

Speaker Change: On slide 18, we show the preliminary efficacy data the.

Speaker Change: The swimmer plot shows each patient and the red cell transfusions by dose group, starting with the lowest dose group 250 milligrams daily on top.

Lisa: 18 patients were evaluable for efficacy, meaning that they had received one or more of our 289 doses and had at least one efficacy assessment.

Speaker Change: The idea we achieved 2018 criteria the transfusion history for each patient was collected for 16 weeks prior to our 289 administration to establish the baseline transfusion frequency for each patient shown to the left a day zero, which is indicated by the Red Arrow.

Lisa: Red blood cell transfusion independence, lasting eight weeks or longer was achieved by three patients one receiving 500 milligrams daily and to receiving 750 milligrams daily.

Lisa: Red blood cell transfusion independents left for more than six months and two patients and one patient also achieved a marrow complete response.

Speaker Change: 18 patients were evaluable for efficacy, meaning that they had received one or more or 289 doses and had at least one efficacy assessment.

Lisa: The median duration of transfusion independence was 29 weeks.

Speaker Change: Red blood cell transfusion independence, lasting eight weeks or longer was achieved by three patients one receiving 500 milligrams daily to receiving 750 milligrams daily.

Lisa: In addition, one high transfusion burden patients receiving 500 milligrams daily achieved a minor ache hi, E response, with a 64% reduction in red cell transfusions compared to baseline.

Raul Rodriguez: I'll ask Lisa to take a shot at it.

Lisa Rojkjaer: And also, I think, you know, this is a start that there's two different studies here, two different patient populations. The Target D program, which, you know, we're delighted. It's an umbrella study that was already underway, which allows us to add our product to that one. So logistically, facilitates the start and initiation of that study. It's a bit different a population than what we're contemplating in our own clinical study.

Speaker Change: Red blood cell transfusion independents lasts for more than six months and two patients and one patient also achieved a marrow complete response.

Lisa: Looking at PK, we noticed that our 289 doses of 500 milligrams once daily and higher or 835 plasma concentrations reached or exceeded those correlating with 50% or 90% L.

Speaker Change: The median duration of transfusion independence was 29 weeks.

Speaker Change: In addition, one high transfusion burden patients receiving 500 milligrams daily achieved a minor ache hi, E response, with a 64% reduction in red cell transfusions compared to baseline.

Lisa: L. P. S induced cytokine inhibition that was previously observed in healthy volunteers.

Lisa: And what's interesting is that at these doses I E 500, and 750 milligrams once daily 40% or four out of 10, Evaluable transfusion dependent patients achieved transfusion independence.

Lisa Rojkjaer: Maybe you can give us a bit more color, Lisa. Yeah, sure. Thanks for the question, Kalpit. So yeah, as Raul mentioned, we're supporting this, the CONNECT umbrella study. Our arm is looking at the combination of, as I mentioned, elutocidinib with temozolomide as maintenance. So in the maintenance setting, so these will be targeting patients that are post-surgery and radiotherapy. So it's temozolomide, elutocidinib for one year, followed by one more year of elutocidinib monotherapy maintenance. And this is going to be focused on patients with grade three astrocytoma. So looking for an impact on progression-free survival. We're happy to be, you know, working with CONNECT on this one.

Speaker Change: Looking at PK, we noticed that there are 289 doses of 500 milligrams once daily and higher or 835 plasma concentrations reached or exceeded those correlating with 50% or 90% L.

Lisa: Moving to slide 19, you can see the summary of the responding patients a few things to highlight here.

Speaker Change: L. P. S induced cytokine inhibition that was previously observed in healthy volunteers.

Lisa: The majority of responding patients were high transfusion burden at baseline and had received a variety of prior therapies, including with status up I can methylated agents and even some experimental therapies.

Speaker Change: And what's interesting is that at these doses I E 500, and 750 milligrams once daily 40% or four out of 10, Evaluable transfusion dependent patients achieved transfusion independence.

Lisa: Both patients achieving durable transfusion independence lasting more than six months patients four and 10 were high transfusion burden at baseline and had received hma's.

Speaker Change: Moving to slide 19, you can see the summary of the responding patients.

Speaker Change: Things to highlight here.

Lisa: Beneath the table, we see the hemoglobin levels over time for the three patients that became transfusion free.

Speaker Change: The majority of responding patients were high transfusion burden at baseline and had received a variety of prior therapies, including with patterns that I put methylated agents and even some experimental therapies.

Lisa Rojkjaer: It's a unique population. These are adolescents and young adults. We're looking to kind of help expand that site, the sites also, because they're a pediatric organization, potentially into more adult sites. And we think it complements our strategy nicely with our plans to go into recurrent glioma.

Lisa: Although patient 10 in the Middle eventually lost their response following a drug interruption in dose reduction on the background and transfusion independence peak hemoglobin increases ranging from 2.3 to 5.6 grams per deciliter compared to baseline were observed indicating that our 289 has the potential to correct.

Speaker Change: Both patients achieving durable transfusion independence lasting more than six months patients four and 10 were high transfusion burden at baseline and have received hma's.

Raul Rodriguez: Now, we're not discussing any of the details about our plans yet, but we will be sharing more about that later on in the year. Okay, wonderful.

Speaker Change: Beneath the table, we see the hemoglobin levels over time for the three patients that became transfusion free.

Lisa: Anemia, providing support for its evaluation earlier in treatment.

Lisa: In summary, the initial data is encouraging showing our 289 is generally well tolerated with promising signs of preliminary activity in heavily pretreated transfusion dependent patients. We look forward to sharing additional data from this study in the second half of this year.

Speaker Change: Although a patient 10 in the middle eventually lost the response following a drug interruption in dose reduction on the background and transfusion independence pink hemoglobin increases ranging from 2.3 to five six grams per deciliter compared to baseline were observed indicating that our 289 has the potential to correct.

Raul Rodriguez: And then one quick question on the, the patent litigation that that you resolved with, with an OROP or Cablese. I guess, are there any other ANDA filers that investors need to be aware of? No, there's no undeciders that we are aware of. Okay, perfect.

Lisa: Now, let's shift focus to allude to Sydney are I D. H one inhibitor.

Speaker Change: Anemia, providing support for its evaluation earlier in treatment.

Lisa: Beginning on slide 21, Glioma is an area that is incredibly challenging where there's not been much advancement in therapeutic options.

Kalpit Patel: Thank you very much for getting the question. Thank you, Kalpit.

Speaker Change: In summary, the initial data is encouraging showing our 289 is generally well tolerated with promising signs of preliminary activity in heavily pretreated and transfusion dependent patients.

Joe Pantginis: And your next question comes from Joe Pantginis with...

The physical elements of the most common primary brain tumor in adults affecting approximately 20000 in the U S. Each year.

Joe Pantginis: Wainwright Hi guys, good afternoon, thanks for taking the question. So first, when you're looking at your product sales, and it's nice to see your core revenue from Tavalees continuing to expand, Govretto increased, you saw a little bit of increase from Rez Lydia, a little bit down from Tavalee. So I guess any commentary with regard to typical first quarter resets. Are you seeing what you expected? And what I'm getting at here is, you know, the turbulence in the environment right now, and yeah, I'll put in quotes, drama around people trying to understand what might be happening with regard to Medicare changes.

Speaker Change: We look forward to sharing additional data from this study in the second half of this year.

Lisa: D H one mutations occur in about 70% of patients with grade two and three fully OMA and founded up to almost 35% of the adolescent and young adult patients.

Speaker Change: Now, let's shift focus to Alicia Sydney, our I D H one inhibitor.

Speaker Change: Beginning on slide 21, we all know is an area that is incredibly challenging where theres not been much advancement in therapeutic options.

Lisa: Fortunately most of disease recurrence and there's no standard of care therapies for relapsed patients.

Lisa: The recent approval enforced sitting up in I D. H, one and two inhibitor and grade two low grade gliomas as highlighted the potential for I D H inhibitors in glioma.

Speaker Change: Physically almonds are the most common primary brain tumor in adults affecting approximately 20000 in the U S. Each year.

Speaker Change: D H one mutations occur in about 70% of patients with grade two and three and they're founded up to almost 35% the adolescent and young adult patients.

Lisa: Alyssa setting up was previously evaluated in a phase <unk> study in 26 patients, which was previously published in the journal Neuro oncology.

Speaker Change: Unfortunately, most of disease recurrence and there is no standard of care therapies for relapsed patients.

Lisa: Two patients with high grade Gliomas achieved partial responses and both within Hudson tumors, and 10 patients achieved stable disease for a disease control rate of 48%.

Joe Pantginis: Yeah, why don't you, Dave, maybe you can comment and I know Dean has a comment on that as well. Sure. Thanks for the question, Joe. Actually, you know, for Q1, we're quite pleased with our progress on all three brands. We grew demand for all three brands. And so I think we're right where we want to be, which is why, you know, we're sticking with our guidance. And I think, you know, our signs for Q1, obviously, we, we did go into it, kind of, prepared for the changes, particularly with respect to the Inflation Reduction Act. And I think we did a really, the team did a terrific job making sure that patients understood the changes and all of the factors that would enable them to have medications in at the end of the day to continue to grow.

Speaker Change: The recent approval of course sitting up in I D. H, one and two inhibitor and grade two low grade gliomas as highlighted the potential for I D H inhibitors in glioma.

Lisa: This clinical proof of concept supports further evaluation of allude to sit and they've been glioma.

Speaker Change: Alicia sitting up was previously evaluated in the phase one two study in 26 patients, which was previously published in the journal of Neuro oncology.

Lisa: Moving to slide 22, we outline our development approach simply on that.

Lisa: Last year, we entered a collaboration with the global Neuro oncology consortium connect.

Speaker Change: Two patients with high grade glioma achieved partial responses and both with Hudson tumors.

Lisa: And connects target trial, a molecularly guy that phase II umbrella clinical trial for high grade glioma.

Speaker Change: 10 patients achieved stable disease for a disease control rate of 48%.

Lisa: I just sponsored arm of the study target D will evaluate a post radiotherapy maintenance regimen of Alicia sitting up in combination with <unk>, followed by a looser sit in that monotherapy in newly diagnosed patients between 12, and 39 years of age with IV H, one mutation positive high grade.

Speaker Change: This clinical proof of concept supports further evaluation of allude to sit and they've been glioma.

Speaker Change: Moving to slide 22, we outline our development approach simply on that.

Speaker Change: Last year, we entered a collaboration with the global Neuro oncology consortium connect.

Speaker Change: And connects target trial Molecularly Guy that's phase two umbrella clinical trial for high grade glioma.

Lisa: Uh huh.

Lisa: This study is open for enrollment.

Lisa: In addition, we're on track to initiate a phase II clinical study in recurrent Liana later this year.

Speaker Change: I just sponsored arm of the study target D will evaluate a post radiotherapy maintenance regimen of Alicia sitting up in combination with <unk>, followed by a looser sit in that monotherapy in newly diagnosed patients between 12, and 39 years of age with IV H, one mutation positives I agree.

Lisa: We think this is an important opportunity as there is a significant unmet need in this patient population.

Dean Schorno: Yeah, I think Dave has that right. So we're pleased with the demand side of the equation. And we did see the expected drawdown in inventory, resulting in still a 68% year-over-year growth. So a strong quarter for us.

Lisa: We along with connect are excited about Elisa cydnus potential to provide a much needed new treatment option to this underserved patient population and we look forward to the data generation from the connect study. In addition to our planned study in recurrent glioma.

Speaker Change: Sure.

Speaker Change: This study is open for enrollment.

Speaker Change: In addition, we are on track to initiate a phase two clinical study in recurrent Liana later this year.

Joe Pantginis: Right, thanks for the info. Thank you, Joe.

Lisa: On slide 23, you'll see another important collaborations our strategic alliance with the MD Anderson cancer Center to advance a leukocyte more broadly into a M. L. M D S and beyond.

Operator: Another reminder to the audience, to ask a question at this time, press star 1 on your telephone keypad. You can press star 2 to remove yourself from the question.

Speaker Change: We think this is an important opportunity as there is a significant unmet need in this patient population.

Speaker Change: We along with connect are excited about Elisa cydnus potential to provide a much needed new treatment option to this underserved patient population and we look forward to the data generation from the Kinect study. In addition to our planned study in recurrent glioma.

Farzin Haque: And your next question comes from Farzin Haque with Jeffries Police. Hi, thank you for taking my question. I had a couple. I guess I'll start with R289.

Lisa: Four studies included in this collaboration are open for enrollment and we look forward to sharing updates from this collaboration in the future.

Lisa: Turning to our partnered program.

Lisa Rojkjaer: Are you saying more on how you're setting expectations for the split doses that you're exploring post-ASH, like with the dose level 5 and 6? And then, just to clarify, for advancing to the recommended phase 2 dose, would you need regulatory feedback on dose escalation data?

Lisa: On slide 25, as Rahul mentioned, we're very excited about the Lilly collaboration for OCA do searches on the CNS Penetrant program.

Speaker Change: On slide 23, you'll see another important collaborations our strategic alliance with the MD Anderson cancer Center to advance a leukocyte more broadly into AML Mds and beyond.

Lisa: The risk K, one inhibitor programs are progressing well with our partner Lilly and we're very pleased with the program's potential.

Speaker Change: All four studies included in this collaboration are open for enrollment and we look forward to sharing updates from this collaboration in the future.

Lisa Rojkjaer: Yeah, I'll let Lisa to comment on that. Yeah, thank you for the question. So in terms of, we don't really have any expectations. I'm not sure I understand the question. We have switched, I'll provide an answer and you can tell me if I've answered it satisfactorily. We switched some time ago from once daily to twice daily dosing because we thought that biologically it makes more sense to maintain a tonic suppression of inflammation as opposed to having this once daily like peak and trough and peak and trough in terms of that from that aspect. And that's why we switched to explore the BID dosing.

Lisa: Rick K, one is implicated in a broad range of inflammatory cellular processes and plays a key role in TNF signaling.

Turning to our partnered program.

Lisa: Okay do searches the non CNS penetrant repay one inhibitor previously referred to as the RFID type. Two is currently being studied in an adaptive phase two a two b clinical trial and up to 380 patients with active moderate to severe rheumatoid arthritis phase.

Speaker Change: On slide 25, as Rahul mentioned, we're very excited about the Lilly collaboration for OCA do searches on the CNS Penetrant program.

Speaker Change: The rip kinase one inhibitor programs are progressing well with our partner Lilly and we're very pleased with the program's potential.

Lisa: Plays to a enrollment is advancing well.

Speaker Change: With a K one is implicated in a broad range of inflammatory cellular processes and plays a key role in CNS signaling.

Lisa: The preclinical CNS penetrant Rip K one inhibitor program is also progressing towards lead candidate nomination.

Speaker Change: Oh could do searches the non CNS penetrant repay one inhibitor previously referred to as the RFID type. Two is currently being studied in the adaptive phase two a two b clinical trial and up to 380 patients with active moderate to severe rheumatoid arthritis.

Lisa: Moving to slide 26, we outlined several upcoming milestones for our development programs in 2025.

Lisa: For our ongoing are 289 program in lower risk Mds, we expect to complete the dose escalation part of the phase <unk> study.

Lisa Rojkjaer: You know, we're progressing up. We had some preliminary data on the 250 BID. We've now completed enrollment of the 500-250 and now into the 500 BID.

Speaker Change: Phase two enrollment is advancing well.

Lisa: We then plan to initiate the dose expansion phase later this year.

The preclinical CNS penetrant <unk> PD one inhibitor program is also progressing towards lead candidate nomination.

Lisa Rojkjaer: So as I mentioned, we're going to be updating data at ASH. Share that with you later on this year. I think we'll share some PK data as well that I think will contribute to what I mentioned in terms of it may be better to kind of have that more. prolonged exposure, as opposed to the up and down.

Lisa: Also during the year, we plan to seek health authority input on the Registrational path for our two late night.

Speaker Change: Moving to slide 26, we outlined several upcoming milestones for development programs in 2025 four.

Lisa: And we're anticipating presenting updated dose escalation data in the second half of the year.

Lisa: And then for Luca sitting up we plan to initiate a phase II clinical study in recurrent glioma by year end, we'll provide you with more details about that study later this year.

Speaker Change: For our ongoing are 289 program in lower risk Mds, we expect to complete the dose escalation part of the phase <unk> study.

Speaker Change: We then plan to initiate the dose expansion phase later this year.

Lisa: In addition, we'll continue to support the four M D. Anderson studies and the Kinect study.

Lisa Rojkjaer: With respect to the, you mentioned the alignment or how to select the doses. So as you're aware, the FDA has encouraged companies now to align with Project Optimist to ensure more robust dose selection early before advancing into phase two. So consistent with that, we will be seeking input from the FDA, aligning with them on the two doses for comparison in the dose escalation part of the study, and we'll be doing that mid-year.

Speaker Change: Also during the year, we plan to seek health authority input on the Registrational path for our two late night.

Lisa: We're excited about the potential of our development programs and look forward to providing updates in the future.

Speaker Change: And we're anticipating presenting updated dose escalation data in the second half of the year.

Dan: Now I will pass the call to Dan to discuss our financial results for the quarter.

Speaker Change: And then for Luca sitting up we plan to initiate a phase II clinical study in recurrent glioma by year end, we'll provide you with more details about that study later this year.

Lisa: Yes.

Lisa: I'm on slide number 28, we reported net product sales of $43 $6 million for the first quarter growth of 68% year over year, including top of we used net product sales of $28 $5 million a growth of 35% year over year got Redrow net product sales of 9 million.

Speaker Change: In addition, we'll continue to support the four M D. Anderson studies and the Kinect study.

Speaker Change: We're excited about the potential of our development programs and look forward to providing updates in the future.

Raul Rodriguez: And then for a follow-up on the earlier question on the ANDA filing, so ANORA is one example and they cannot enter the market, I think it mentioned prior to 2Q32, but if there are additional ANDA filers in the future, could they have an earlier market entry or is that 2Q32 pretty much? Yeah, you can get secondhand defilers, and they would need to, they would need to defeat the patents, which in order to enter the market earlier than the current last list of patents, which would July 27, 2032, but there's a possibility of an underfiler, but once there's one entrant already where there's a settlement, it's a disincentive to second filers and tertiary filers, but it is technically possible.

Now I will pass the call to Dan to discuss our financial results for the quarter.

Lisa: As a reminder, that router became available from Rigel in June of 2024.

Dan: Thank you Richard I'm on Slide number 28, we reported net product sales of $43 $6 million for the first quarter growth of 68% year over year, including top of weak net product sales of $28 $5 million or growth of 35% year over year got redrow net product sales.

And we reported Roes median net product sales of $6 $1 million a growth of 25% year over year.

Our net product sales from <unk> got rather than Rosemary yet where we're at.

Lisa: Accorded net of estimated discounts charge backs rebates returns co pay assistance and other allowances of 16, four and $6 million.

Dan: With $9 million as a reminder, Jeb Ryder became available Rigel in June of 2024.

Lisa: As anticipated we saw a sequential decrease in net product sales from the fourth quarter of 2024.

Dan: We reported net product sales of $6 1 million a growth of 25% year over year.

Lisa: With our remarks on our fourth quarter earnings calls and what we've seen in past first quarters. Our revenues were impacted by a drawdown in inventory levels across our distribution channels.

Dan: Our net product sales from probably east cam rather than Rosemary.

Dan: Net of estimated discounts charge backs rebates returns co pay assistance and other allowances of $16 $6 million.

Lisa: We also reported $9 $8 million in contract revenues from our collaborators at the first quarter.

Lisa: I mean, it really driven by contributions from referrals to say, which included the $3 million milestone payment and medicine, bringing our total revenues for the first quarter to $53 $3 million.

Dan: As anticipated we saw a sequential decrease in net product sales from the fourth quarter of 2024, consistent with our remarks on our fourth quarter earnings call and what we've seen in past first quarters. Our revenues were impacted by a drawdown in inventory levels across our distribution channels.

Raul Rodriguez: But we haven't seen this yet. No, we have not, we have not, you know, there's no, we have no notice of a second file. Thank you. Thank you, Farzin. Thank you.

Lisa: Finally, I'd like to take a moment to discuss the reporting impact Martin notification to limited and we will not exercise their opt in right related to the development and commercialization of brokerage assertive for the treatment of non CNS diseases.

Dan: Also reported $9 $8 million in contract revenues from our collaborators for the first quarter.

Operator: And there are no further questions at this time.

Dan: Really driven by a contribution of false to say, which included the $3 million milestone payment and medicine, bringing our total revenues for the first quarter to $53 $3 million.

Raul Rodriguez: I would like to turn the floor back over to Mr. Raul Rodriguez for closing comments. Thank you. I'd like to thank everyone for joining us on the call today. You know, it was the start of a very strong year. First quarter was an excellent quarter for us. We're very happy with what we were able to accomplish in this quarter. It sets us up very well for a very strong calendar year. And so for that, I'd like to thank you for your continued interest at Rigel.

Lisa: As a result of this notification from the second quarter, we expect to recognize approximately $40 million in collaboration revenue.

Lisa: This is noncash and related to the release of the remaining caution or liability currently on our balance sheet.

Dan: Finally, I'd like to take a moment to discuss the reporting impact Martin notification to Lilly and we will not exercise their opt in right related to the development and commercialization of <unk> for the treatment of non CNS diseases.

Under the terms of our collaboration agreement Roger will continue to be entitled to receive milestone and tiered royalty payments on future net sales.

Lisa: Moving onto the next slide and down the income statement in cost and expenses.

Dan: As a result of this notification from the second quarter, we expect to recognize approximately $40 million in collaboration revenue.

Raul Rodriguez: I'd like to also thank our employees and for their commitment to Rigel and our values, particularly our commitment to improving the lives of patients. We will keep you updated on future calls as the year progresses. And with that, have a good day. Thank you.

Lisa: Cost of product sales were approximately $4.4 million from first quarter of 2025.

Dan: This is noncash and related to the release of the remaining cost share liability currently on our balance sheet.

Lisa: Costs and expenses were $46 million compared to $36 $5 million for the same period of 2024.

Dan: Under the terms of our collaboration agreement Roger will continue to be entitled to receive milestone and tiered royalty payments on future net sales.

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

Lisa: The increase in costs and expenses was mainly due to increased personnel related costs and higher R&D costs, driven by retirement of critical activities.

Dan: Moving onto the next slide and down the income statement in costs and expenses.

Lisa: To Archer at nine and we're just sitting there.

Dan: Cost of product sales were approximately $4 $4 million for the first quarter of 2025.

Lisa: In addition cost of product sales increase driven by increased product sales higher royalties and amortization of intangible assets. These increases were partially offset by decreased stock based compensation expense.

Dan: Total costs and expenses were $46 million compared to $36 $5 million for the same period of 2024.

Dan: The increase in cost and expenses was mainly due to increased personnel related costs and higher R&D costs, driven by the timing of clinical activities.

Lisa: We reported net income of $11 $4 million for the first quarter compared to a net loss of $8 $2 million in the same period in 2024.

Dan: Orange retinoid.

Lisa: We ended the quarter with cash cash equivalents and short term investments of $77 $1 million similar to the $77 $3 million as of the end of 2024.

Yeah.

Dan: In addition cost of product sales increase driven by increased product sales and higher royalties and amortization of intangible assets. These increases were partially offset by decreased stock based compensation expense we.

Lisa: Before I discuss our financial outlook for 2025, I want to spend a moment discussing potential terrorists to rigel as a result of global trade tensions.

Dan: We reported net income of $11 $4 million for the first quarter compared to a net loss of $8 $2 million in the same period in 2024.

Lisa: Roger uses a group of typical third party contract manufacturers for API and finished goods manufacturing some of which are located outside the U S. Given the uncertainty we're not prepared to provide an expected impact of potential tariffs today we.

Dan: <unk> ended the quarter with cash cash equivalents and short term investments of $77 $1 million similar to the $77 $3 million as of the end of 2024.

Lisa: We do expect any impact to be modest.

Dan: Before I discuss our financial outlook for 2025, I want to spend a moment discussing potential terrorists to rigel as a result of global trade tensions.

Lisa: It appears domiciled in the U S.

Lisa: Turning to our financial outlook for 2025, we continue to anticipate total revenue in the range of approximately $200 million to $210 million. This includes our unchanged expectation of approximately $185 million to $192 million and net product sales and $15 million to $18 million of contract revenues.

Dan: Roger uses a group of typical third party contract manufacturers for API and finished goods manufacturing some of which are located outside the U S. Given the uncertainty we're not prepared to provide an expected impact of potential tariffs today.

Dan: We do expect any impact to be modest.

Lisa: From collaborations.

Lisa: In addition, we continue to anticipate reporting positive net income for year of 2025, while funding existing and new clinical development programs.

Dan: It appears domiciled in the U S.

Dan: Turning to our financial outlook for 2025, we continue to anticipate total revenue in the range of approximately $200 million to $210 million. This includes our unchanged expectation of approximately $185 million to $192 million in net products sales and $15 million to $18 million of contract revenues.

Lisa: Note that our 2025 revenue guidance excuse me approximately $40 million in noncash collaboration revenue is expected to be recognized in the second quarter trauma, we'd ramp up.

Dan: Collaborations.

Speaker Change: Wrap up my section, we look forward to continued financial discipline for the remainder of 2025 M yard Rick I'd like to turn the call back over to Ralph.

Dan: In addition, we continue to anticipate reporting positive net income for the full year of 2025, while funding existing and new clinical development programs.

Speaker Change: Thank you Dean moving onto slide 30, we've made significant strides over the past three years to expand our commercial portfolio.

Dan: Note that our 2025 revenue guidance excuse me approximately $40 million in noncash collaboration revenue is expected to be recognized in the second quarter.

Speaker Change: Sensing or acquiring assets that fit our commercial capabilities and portfolio of focus.

Speaker Change: We have a proven track record of delivering top line growth as evidenced by the 32% compound annual growth rate of cargo and revenue growth from 2021 to 'twenty 'twenty four.

Dan: To wrap up my section, we look forward to continued financial discipline for the remainder of 2025 and beyond with that I'd like to turn the call back over to Ralph.

Speaker Change: This revenue growth enables us to fund our business and our strategic priorities, including to continue expanding our hematology and oncology business.

Ralph: Thank you Dean moving onto slide 30, we made significant strides over the past three years to expand our commercial portfolio.

Speaker Change: Sensing or acquiring assets that fit our commercial capabilities and portfolio of focus.

Speaker Change: And we're confident in our expectation of approximately 185 to 192 million and net product sales this year.

Speaker Change: We have a proven track record of delivering top line growth as evidenced by the 32% compound annual growth rate and.

Speaker Change: Turning to slide 31.

For the remainder of 2025, our priorities are clear grow our commercial business.

Speaker Change: And revenue growth from 2021 to 'twenty 'twenty four.

Speaker Change: Dance, our development pipeline identified new pipeline opportunities and continue to maintain financial discipline.

Speaker Change: This revenue growth enables us to fund our business and our strategic priorities, including to continue expanding our hematology and oncology business and.

Speaker Change: We anticipate growing our net product sales in 2025 by approximately 30% year over year.

Speaker Change: And we're confident in our expectation of approximately $185 million to $192 million and net product sales this year.

Speaker Change: We remain focused on advancing our phase <unk> clinical study evaluating our two ignoring for the treatment of patients with lower risk Mds and we are on track to publish updated data at a medical meeting later this year and the initiated a dose expansion phase of this study by year end.

Speaker Change: Turning to slide 31.

Speaker Change: For the remainder of 2025, our priorities are clear grow our commercial business.

Speaker Change: Advance our development pipeline identified new pipeline opportunities and continue to maintain financial discipline.

Speaker Change: For the visit we plan to initiate a new Rogers sponsored phase II study in recurrent glioma, while continuing to support our strategic collaborations with both MD Anderson interconnect organization.

Speaker Change: We anticipate growing our net product sales in 2025 by approximately 30% year over year.

Speaker Change: We remain focused on advancing our phase <unk> clinical study evaluating arc to ignore and for the treatment of patients with lower risk Mds and we are on track to publish updated data at a medical meeting later this year and initiating the dose expansion phase of this study by year end.

Speaker Change: With our anticipated strong revenue growth financial discipline in 2025, we will continue to invest in our development programs, but also expect to report positive net income for the full year.

Speaker Change: Finally on slide 32, our successful execution of our corporate strategy has resulted and Raj will be uniquely positioned and building, a leading hematology and oncology business.

Speaker Change: For those who does it and that we plan to initiate a new rigel sponsored phase II study in recurrent glioma, while continuing to support our strategic collaborations with both MD Anderson interconnect organization.

Speaker Change: <unk> and sustainable manner.

Speaker Change: With our anticipated strong revenue growth financial discipline in 2025, we will continue to invest in our development programs, but also expect to report positive net income for the full year.

Speaker Change: And with that I'd like to thank you for your interest and we will now open the call to your questions.

Speaker Change:

Speaker Change: Yes.

Speaker Change: If you would.

Speaker Change: To ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate that your line is in the question queue you.

Speaker Change: Finally on slide 32, our successful execution of our corporate strategy has resulted in rigel being uniquely positioned in building, a leading hematology and oncology business unit.

Speaker Change: You May press Star two if you would like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys. Once again to ask a question press star one on your telephone keypad.

Speaker Change: <unk> and sustainable manner.

Speaker Change: And with that I'd like to thank you for your interest and we will now open the culture questions.

Speaker Change: Operator.

Speaker Change: Thank you.

Speaker Change: Stand by while we poll for questions.

Speaker Change: I'd like to ask a question. Please press star one on your telephone keypad.

Speaker Change: For me the tone will indicate that your line is in the question queue.

Speaker Change: And our first question comes from cockpit Patel with B Riley Securities. Please state your question.

Speaker Change: You May press Star two if you would like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys. Once again to ask a question press star one on your telephone keypad.

Cockpit Patel: Yeah, Hey, good afternoon, and thanks for taking the question.

Cockpit Patel: I had one on the the target the.

Cockpit Patel: Program that you have ongoing and high grade glioma.

Speaker Change: Stand by while we poll for questions.

Cockpit Patel: I guess you have two different plans here for like we all might you have that study running and then you also have the.

Speaker Change: And our first question comes from cockpit Patel with B Riley Securities. Please state your question.

Cockpit Patel: Planned company sponsored phase III trial, we correctly Omar can.

Cockpit Patel: Yeah, Hey, good afternoon, and thanks for taking the question.

Cockpit Patel: Can you help us clarify the objective then perhaps the design differences between the two and longer term you know what.

Speaker Change: I had one on B.

Cockpit Patel: The target D.

Cockpit Patel: Program that you have ongoing and high grade glioma.

Mark: Mark do you want to see in the target deep program.

Cockpit Patel: Testify moving forward in <unk>.

Cockpit Patel: I guess you you have two different plans here for glioma you have that study running and then you also have the.

Cockpit Patel: One program or the other.

Speaker Change: I'll ask Lisa to take a shot at it and then also I think you know that this is a start then there's two different studies are two different patient populations.

Cockpit Patel: Planned company sponsored phase III trial in recurrent glioma.

Cockpit Patel: Can you help us clarify the objective than perhaps the design differences between the two and longer term you know what what signal do you want to see in the target deep program.

Speaker Change: The target deep program, which innerwear, we're delighted itself umbrella study that was already underway, which allows us and our product to about one so logistically a facilitator to start with initiation of that study.

Cockpit Patel: To justify moving forward.

Cockpit Patel: In one program or the other.

Speaker Change: It's a bit different population than what we're contemplating in our own clinical study.

Cockpit Patel: I'll ask Lisa to take a shot at it and then also I think you know that you did this at the start that there's two different studies are two different patient populations.

Speaker Change: More color yes.

Speaker Change: Yeah sure. Thanks for the question.

Speaker Change: So yeah, it's real.

Cockpit Patel: The target deep program, which are in a world where I'm delighted himself umbrella studied that was already underway, which allows us to add our products about one so logistically.

Speaker Change: Lou mentioned, we're supporting this the connect umbrella study our arm is looking at the combination of as I mentioned, the looser sitting up was 10 months old or might as maintenance. So in the maintenance setting. So these will be targeting patients that are post surgery and radiotherapy. So it's kind of as a reminder, Lucas.

Cockpit Patel: Facilitate stuff starting to initiation of that study its a bit different population than what we're contemplating in our own clinical study.

Cockpit Patel: And more colors.

Speaker Change: For one year, followed by one more year of allude to sit in the monotherapy maintenance.

Cockpit Patel: Sure. Thanks for the question so yeah.

Yeah, Rahul mentioned, we're supporting this the connect umbrella study our arm is looking at the combination of.

And this is going to be focused on on patients with grade three astrocytoma, so looking for and impact on progression free survival, we're happy to be working with connect on this one it's a unique population. These are adolescents and young adults are we're looking to.

Cockpit Patel: The looser Sydney was coming solely mine as maintenance so in the maintenance setting. So these would be targeting patients that are post surgery and radiotherapy.

Cockpit Patel: So it depends a little idle interested in them for one year, followed by one more year of allude to sit in the monotherapy maintenance and this is going to be focused on on patients with with grade three astrocytoma. So looking for an impact on progression free survival, where.

Speaker Change: Kind of helps expand that site at the sites also because there are pediatric organization potentially into or adult sites and we think it complements our strategy nicely with our plans to go into recurrent glioma.

Speaker Change: Now were not discussing any of the details about our plans yet, but we will be sharing more about that later on in the year.

Cockpit Patel: Happy to be working with connect on this one it's a unique population. These are adolescents and young adults were.

Cockpit Patel: We're looking to kind of helps expand that site at the sites also because there are pediatric organization potentially into or adult sites and we think it complements our strategy nicely with our plans to go into recurrent glioma.

Speaker Change: Okay Wonderful and then one quick question on B B.

Speaker Change: The patent litigation that you resolved with a with an offer I believe.

Speaker Change: I guess are there any other anti filers that.

Speaker Change: Customers need to be aware of.

Cockpit Patel: Now were not discussing any of the details about our plans yet, but we will be sharing more about that later on in the year.

Speaker Change: No Theres no other fighters and we were aware of.

Talbott: Okay perfect. Thank you very much for taking the question. Thank you talbott.

Speaker Change: Yeah.

Speaker Change: Okay Wonderful and then one quick question on B B.

Speaker Change: And your next question comes from Joe Pan Janus with H C. Wainwright. Please state your question.

Cockpit Patel: The patent litigation that we resolved with the <unk>.

<unk> I believe.

Hey, guys. Good afternoon. Thanks for taking the question. So first when Youre looking at your your product sales and it's nice to see you know your core revenue from <unk> continuing to expand.

Cockpit Patel: I guess are there any other anti filers that.

Cockpit Patel: Investors need to be aware of.

Cockpit Patel: No theres no identified or something we were aware of.

Cockpit Patel: Okay perfect. Thank you very much for taking the questions. Thank.

Speaker Change:

Speaker Change: Cavetto increased you saw some a little bit of increase or.

Kelvin: Thank you Kelvin.

Speaker Change: And your next question comes from Joe Pan Janus with H C. Wainwright. Please state your question.

Speaker Change: From raws, Lydia little bit down from tablet. So I guess any commentary with regard to typical first quarter resets are you seeing what you expected and what I'm getting at here is you know the turbulence in the environment right now and yeah I'll put in quotes drama around people trying to understand what.

Joe Pan: Hey, guys. Good afternoon. Thanks for taking the question. So first when Youre looking at your your product sales and it's nice to see.

Speaker Change: Your core revenue from <unk> continuing to expand.

Joe Pan:

Joe Pan: Cabrito increased you saw some a little bit of increase or.

Speaker Change: Might be happening with regard to Medicare changes as well.

Dave Brito: Yeah I wanted to ask Dave maybe you can comment and I don't think it has a comment on that as well.

Joe Pan: From raws, Lydia little bit down from tablet. So I guess any commentary with regard to typical first quarter resets are you seeing what you expected and what I'm getting at here is you know the turbulence in the environment right now and yeah I'll put in quotes drama around people trying to understand what.

Dave Brito: Sure. Thanks for the question Joe actually you know for Q1 were quite pleased with our progress on all three brands. We grew demand for all three brands and so I think we're right, where we want to be which is why you know where.

Joe Pan: It might be happening with regard to Medicare changes as well.

Dave Brito: Sticking with our guidance and I think you know.

Joe Pan: Yeah, one of the day, but maybe you can comment and I don't think it has a comment on that as well.

Dave Brito: Our signs for Q1, obviously, we we did go into it.

Joe Pan: Sure. Thanks for the question Joe actually you know for Q1, we were quite pleased with our progress on all three brands. We grew demand for all three brands and so I think we're right where we want to be which is why we are.

Dave Brito:

Dave Brito: Right.

Dave Brito: Prepared food.

Dave Brito: For.

Dave Brito: The changes, particularly with respect to the inflation reduction Act and I think we did a really the team did a terrific job, making sure that patients understood.

Joe Pan: Sticking with our guidance.

Joe Pan: I think you.

Dave Brito: The changes and all.

Joe Pan: Our signs for Q1, obviously, we we did go into it kind of.

Dave Brito: All of the factors that would enable them to have medications in at the beginning of the year and I think we pulled that through quite successfully and our demand continue to grow.

Joe Pan: Prepared.

Joe Pan: For.

Joe Pan: The change is particularly with respect to the inflation Protection Act.

Speaker Change: Yeah, I think they they've had that right. So that we're pleased with the demand side of the equation and we did see the expected drawdown in inventory, resulting in still a 68% year over year growth, So a strong quarter for us.

Joe Pan: And I think we did a really the team did a terrific job, making sure the patients understood.

Joe Pan: The changes and.

Joe Pan: All of the factors that would enable them to have medications in at the beginning of the year and I think we pulled that through quite successfully and our demand continue to grow.

Dave Brito: Right. Thanks for the info.

Joe: Thank you Joe.

Speaker Change: Another reminder, to the audience to ask a question at this time press Star one on your telephone keypad you can press star two terms of yourself from a question for you.

Speaker Change: Yeah, I think David has that right. So we're pleased with the demand side of the equation and we did see do you expect to draw down in inventory, resulting in still a 68% year over year growth, So a strong quarter for us.

Joe: And your next question comes from Zain Hawk with Jefferies. Please state your question.

Zain Hawk: Hi, Thank you for taking my question I had a couple I guess I'll start with a 289 anything more on how you're setting expectations, but the split doses that you're exploring for staff like with that dose level five ethics.

Joe Pan: Right. Thanks for the info.

Speaker Change: Thank you Joe.

Speaker Change: Another reminder, to the audience to ask a question at this time press Star one on your telephone keypad, you can press star two to remove yourself from the question queue.

Speaker Change: And then just to clarify for advancing to the recommended phase two dose would you need regulatory feedback on dose escalation dataset.

Speaker Change: And your next question comes from far Zane Hawk with Jefferies. Please state your question.

Yeah, I'll, let Lisa to comment on that yeah. Thank you for the question. So in terms of we don't really have any expectations I am not sure I understand.

Speaker Change: Hi, Thank you for taking my question I had a couple I guess I'll start with the 289 have you seen more on how you're sitting expectations, but the split doses that you're exploring post ash like with that dose level five and six.

Speaker Change: A question, we have switched I'll I'll I'll provide an answer and you can tell me if I if I've answered it satisfactorily.

Speaker Change: And then just to clarify for advancing to the recommended phase two dose would you need regulatory feedback on dose escalation dataset.

Speaker Change: We switched some time ago from once daily to twice daily dosing, because we thought that biologically it makes more sense to maintain a tonic suppression of inflammation as opposed to having you know this once daily like peaks and troughs and peaks and troughs in terms of that.

Speaker Change: Yeah, I'll, let ask Lisa to comment on that yeah. Thank you for the question. So in terms of we don't really have any expectations I am not sure I understand.

Speaker Change: The question, we have switched I'll I'll I'll provide an answer and you can tell me if I sort of answered satisfactorily.

Speaker Change: From that aspect and that's why we switched to explore the b I D dosing.

We switched some time ago from once daily to twice daily dosing, because we thought that biologically it makes more sense to maintain a tonic suppression of inflammation as opposed to having this once daily like peak and troughs and peaks and troughs in terms of.

Speaker Change:

Speaker Change: You know, where we're progressing up we had some preliminary data on the 250 B I D.

Speaker Change: Now completed enrollment of the 500 to suspend them now into the 500 B I D. So as I mentioned, we're going to be you know updating data at ash and share that with you later on this year.

Speaker Change: From that aspect and that's why we switched to explore the b I D dosing.

I think we'll share some PK data as well that I think will.

Speaker Change: Contributed to what I mentioned in terms of that may be better to kind of have that thought more.

Speaker Change: We're progressing up and we had some preliminary data on the two <unk> B I D.

Speaker Change: We've now completed enrollment of the 502 sits band and now into the 500 B I D. So as I mentioned, we're going to be updating our data at ash share that with you later on this year I think you know well.

Speaker Change: Prolonged exposure as opposed to the the up and down.

Speaker Change: With respect to the you mentioned the alignment or how did you select the doses. So as you are aware the FDA has encouraged companies now to align with project Optimus to ensure more robust dose selection early before advancing into phase two so.

Speaker Change: Sure some PK data as well that I think will.

Speaker Change: Contribute to what I mentioned in terms of that may be better to kind of Todd that that more.

Speaker Change: Consistent with that we will be seeking input from the FDA aligning with them on the two doses for comparison in the.

Speaker Change: Prolonged exposure as opposed to the the up and down.

Speaker Change: With respect to the you mentioned the alignment.

Speaker Change: The dose escalation part of the study and we'll be doing that Smith here.

Speaker Change: Select the doses. So as you are aware the FDA has encouraged companies now to align with project Optimus to insure more robust dose selection early before advancing into phase two so consistent with that.

Speaker Change: Got it that makes sense and then for a follow up on the earlier question on the NDA filing for an order is one example, and they cannot enter the market I think I've mentioned prior to Q2, but if there are additional NDA filings in the future could they haven't eylea market entry or is that to Q2 pretty much when you should see it.

Speaker Change: We will be seeking input from the FDA aligning with them on the two doses for comparison.

Speaker Change: No country.

Speaker Change: The dose escalation part of the study and we'll be doing that mid tier.

Speaker Change: Yeah, you can get secondhand refiners.

Speaker Change: And they would need to they would need to feed the patents.

Got it that makes sense and then for a follow up on the earlier question on the NDA filing for an order is one example, and they cannot entered the market I think had mentioned practice to Q2, but if there are additional NDA filings in the future could they haven't eylea market entry or Easter to Q2 pretty much when you should stand.

Speaker Change: Which is in order to hedge the markers.

Speaker Change: And the current masters to pop which would be.

Speaker Change: July.

27, 2022 23 to.

Speaker Change: But there's a possibility of an undefined or put webster's one entrant.

Speaker Change: Country.

Speaker Change: You can get secondhand refiners and they would need to they would need to feed the patents.

Speaker Change: Already we're just sentiment, it's a disincentive to second fighters and tertiary fibers, but it is technically possible.

Speaker Change: Yeah.

Speaker Change: In order to enter the markers earlier.

Speaker Change: There could be a second filer.

Speaker Change: The current fastest path.

Speaker Change: Got it makes what we haven't seen that.

Speaker Change: Pete.

Speaker Change: No we have not we have not you know there's no we have no eh.

Speaker Change: July.

Speaker Change: 27, 2022 23 to one.

Speaker Change: Notice of a second finer.

Speaker Change: There's a possibility of another refiner put webster's one entrant.

Speaker Change: Got it thank.

Speaker Change: Thank you.

Speaker Change: Sure.

Speaker Change: Thank you person.

Speaker Change: Already where does the settlement, it's a disincentive to second fighters and tertiary fighters, but it is technically possible.

Speaker Change: Thank you and there are no further questions at this time I would like to turn the floor back over to Mr. Raul Rodriguez for closing comments. Thank you.

Speaker Change: There could be a second partner.

Speaker Change: Got it it makes us think we haven't seen.

Speaker Change: Thank you.

Speaker Change: I'd like to thank everyone for joining us on the call today.

Speaker Change: No we have not we have not.

Speaker Change: There's no we have no.

Speaker Change: It was the start of a very strong.

Speaker Change: Notice of a second filers.

Speaker Change: First quarter was an excellent quarter for us we're very happy with what we were able to accomplish for this quarter. It sets us up very well for a very strong calendar year and so for that I'd like to thank you for your continued interest in Rigel I'd like to also thank our employees for their commitment to Roger Almond, our values, particularly our commitment to <unk>.

Speaker Change: Okay.

Speaker Change: Thank you.

Speaker Change: Sure.

Speaker Change: Thank you person.

Speaker Change: Thank you and there are no further questions at this time I would like to turn the floor back over to Mr. Raul Rodriguez for closing comments. Thank you.

Speaker Change: Thank you.

Speaker Change: I'd like to thank everyone for joining us on the call today.

Speaker Change: Proving the lives of patients we will keep you updated on future calls as the year progresses and would that have a good day.

Speaker Change: The start of a very strong first.

Speaker Change: First quarter was an excellent quarter for us we're very happy with what we were able to accomplish in this quarter. It sets us up very well for a very strong calendar year and so for that I'd like to thank you for your continued interest in Rigel I'd like to also thank our employees for their commitment to Roger Almond, our values, particularly our commitment to <unk>.

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

Moving the lives of patients and we'll keep you updated on future calls as the year progresses and with that have a good day.

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