Q2 2024 Rigel Pharmaceuticals Inc Earnings Call
Operator: Greetings and welcome to Rigel Pharmaceuticals' financial conference call for the second quarter of 2024. 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.
Unknown Executive: Greetings and welcome to Regel Pharmaceuticals' financial conference call for the second quarter, 2024. At this time, 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.
Greetings and welcome to Rigel Pharmaceuticals Financial conference call for the second quarter 2024.
Speaker Change: At this time all participants are in a listen only mode. A brief question and answer the answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone keypad.
Speaker Change: As a reminder, this conference is being recorded.
Operator: As a reminder, this conference is being recorded. 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.
Ray Fury: It is my pleasure to introduce our first speaker, Ray Fury, Rigel's Executive Vice President, General Counsel, and Corporate Secretary.
Ray Fury: It is now my pleasure to introduce our first speaker Ray Fury Rigel Executive Vice President General Counsel and corporate Secretary. Thank you. Mr. Ferry you may begin.
Ray Fury: Thank you, Mr. Fury. You may begin. Welcome to our second quarter of 2024 financial results in business update conference call. The financial press release for the second quarter of 2024 is issued a short while ago. It can be viewed along with the slides for this presentation in the News and Events section of our Investor Relations site on Rigel.com.
Raymond Furey: Welcome to our second quarter 2024 financial results and business update conference call. The financial press release for the second quarter of 2024 was issued a short while ago and can be viewed along with the slides for this presentation in the news and events section of our investor relations site on Rigel.com. As a reminder, during today's call, we may make forward-looking statements regarding our financial outlook and our plans and timing for regulatory and product development.
Speaker Change: Welcome to our second quarter 2024 international results.
Speaker Change: A conference call.
Speaker Change: The press release for the second quarter of 2024 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 vital Dot com.
Ray Fury: As a reminder, during today's call, we may make forward-looking statements regarding their financial outlook and our plans and timing for regulatory product development. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecast. A description of these risks can be found in our most recent annual report on phone 10-K through the year ended December 31, 2023, and subsequent fines with the SEC in footing quarter to quarter report on phone 10-K on file with the SEC.
Speaker Change: As a reminder, during today's call.
Speaker Change: May make forward looking statements regardless.
Speaker Change: And our plans and timing for regulatory and product development.
Raymond Furey: These statements are subject to risks and uncertainty that may cause actual results to differ from those for. A description of these risks can be found in our most recent annual report on Form 10-K for the year ended December 31, 2023, and subsequent filings with the SEC, including our Quarter 2 quarterly report on Form 10-Q on file with the SEC. Any forward-looking statements are made only as of today, and we undertake no obligation to update these forward-looking statements to reflect subsequent events or circumstances. At this time, I'd like to turn the call over to our President and Chief Executive Officer, Raul Rodriguez. Raul
Speaker Change: As are subject to risks and uncertainties.
Speaker Change: May cause actual results to differ from those forward.
Speaker Change: Okay.
Speaker Change: A description of these risks can be found in our most recent annual report on form 10.
Speaker Change: For the year ended December 31 2023.
Speaker Change: Subsequent filings with the SEC each.
Quarter to quarter to report on.
Speaker Change: Form 10-Q filed with the SEC.
Ray Fury: 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.
Speaker Change: 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.
Raul Rodriguez: Thank you, Ray, and thank you everyone for joining me today. Also with me today are Dave Santos, our Chief Commercial Officer; Lisa Rojkjaer, our Chief Medical Officer; and Dean Schorno, our Chief Financial Officer. Now beginning on slide four, I'm thrilled to introduce you to Gabretto, the latest addition to Rigel's product portfolio. Gabretto is an FDA-approved therapy for the treatment of red fusion positive metastatic non-small cell lung cancer and advanced or metastatic thyroid cancer that we acquired earlier this year. Gabretto has become commercially available from Rigel on June 27.
Raul Rodriguez: At this time, I'd like to turn the call over to a President and Chief Executive Officer, REL, Rodrigues REL.
Speaker Change: At this time I would like to turn the call over to our President and Chief Executive Officer Raul. Thank you.
Raul Rodriguez: Thank you, Ray, and thank you everyone for joining today.
Speaker Change: And thank you everyone for joining today also with me today are Dave Santos, our Chief commercial officer.
David Santos: Also, with me today are Dave Santos, our Chief Commercial Officer; Mr. Ray Care, our Chief Medical Officer; and the Chornal, our Chief Financial Officer. I'll be getting on slide for you.
Mr <unk>, our Chief Medical Officer, and Dean <unk>, our Chief Financial Officer.
Speaker Change: Now beginning on slide four.
Raul Rodriguez: I'm thrilled to introduce you to Gabredo, the latest addition to Rigel's product portfolio. Gabredo is an FDA-approved therapy for the treatment of red fusion-positive, metastatic, non-small cell lung cancer, and advanced or metastatic thyroid cancer. That we acquired earlier this year. Gabredo has become commercially available from Rigel on June 27. Our patient services, field teams, and distributors were diligently to ensure a smooth transition, enabling us to provide current and newly prescribed patients and their providers. This important treatment, without any interruption. The addition of Gabredo to our growing commercial portfolio, now made up of three products, supports top line growth and leverages our existing commercial and medical affairs expertise and capabilities.
Speaker Change: I'm thrilled to introduce you took out the latest edition to ride those product portfolio. Yes brother is an FDA approved therapy for the treatment of ret fusion positive metastatic non small cell lung cancer and advanced or metastatic thyroid cancer that we acquired earlier. This year <unk> has been commercially available from Rigel on June 20.
Raul Rodriguez: Our patient services, field teams, and distributors will work diligently to ensure a smooth transition, enabling us to provide current and newly prescribed patients and their providers this important treatment option without any interruption. The addition of Gavretto to our growing commercial portfolio, now made up of three products, supports top-line growth and leverages our existing commercial and medical affairs expertise and capabilities. Moving on to slide five.
Speaker Change: Our patient services field teams and distributors worked diligently to ensure a smooth transition, enabling us to provide current and newly prescribed patients and their providers. This important treatment option without any interruption.
Speaker Change: The addition of Red Oak to our growing commercial portfolio now made up of three products supporting top line growth and Leverages, our existing commercial and medical affairs expertise and capabilities.
Raul Rodriguez: Moving on to slide five. In the second quarter, we made meaningful progress towards growing the commercial side of our business. We had 33.5 million of net product sales during the quarter, and increased up 40% over 23.9 million of the second quarter of 2023. The continued report record performance of Tavalese and Resolidio, coupled with the addition of Gabredo, reflects our successful efforts to expand our pathology and oncology portfolio. We looked at growth, continued to grow our existing portfolio, and to expand it with new products in the future.
Speaker Change: Moving on to slide five.
Raul Rodriguez: In the second quarter, we made meaningful progress towards growing the commercial side of our business. We had $33.5 million in net product sales during the quarter, an increase of 40% over $23.9 million in the second quarter of 2023. The continued record performance of Tavalisse and Reslydia, coupled with the addition of Gabretto, reflects our successful efforts to expand our hematology and oncology portfolio. We look to continue to grow our existing portfolio and to expand it with new products in the future.
Speaker Change: Yes.
Speaker Change: In the second quarter, we made meaningful progress towards growing the commercial side of our business. We had $33 5 million of net product sales during the quarter, an increase of 40% over $23 9 million in the second quarter of 2023 to.
Speaker Change: The continued report record performance of tower lease Andres lithium coupled with the addition of get brittle reflects our successful efforts to expand our hematology and oncology portfolio.
Speaker Change: We look to grow continue to grow our existing important product portfolio and to expand it with new products in the future.
Raul Rodriguez: On the development side, our Iraq 1 and 4 inhibitor, R-289, continues to progress in a phase 1B trial in lower risk MDS, with enrollment of the fourth dose group, nearing completion. We remain on track to share preliminary data from this study by the end of this year. Our strategic collaborations with MD Anderson Cancer Center and Connect will enable us to explore Reslidia in a broad range of IDH-1 mutant cancers in a cost and timing-fishing manner. These programs continue to progress, and we're excited to share with you today that our first trial with MD Anderson, evaluating Reslidia in patients where the AML has been opened for enrollment.
Raul Rodriguez: On the development side, our IRAC1N4 inhibitor, R289, continues to progress in a Phase 1B trial in lower-risk FDS, with enrollment of the fourth dose group nearing completion. We remain on track to share preliminary data from this study by the end of this year. Our strategic collaborations with M.D. Anderson Cancer Center and CONNECT will enable us to explore reslydia in a broad range of IDH1 mutant cancers in a cost and time-efficient manner. These programs continue to progress, and we're excited to share with you today that our first trial with M.D. Anderson evaluating Reslydia in patients with AML has opened for enrollment.
On the development side, our Iraq, one and four inhibitor art to ignite continues to progress in our phase one b trial in lower risk Mds with enrollment of the fourth dose group nearing completion.
Speaker Change: We remain on track to share preliminary data from this study by the end of this year.
Speaker Change: Our strategic collaborations with M D. Anderson cancer Center, and connect will enable us to explore was linear and a broad range of body H, one mutant cancers in a cost and time efficient manner. These programs continue to progress and we're excited to share with you today, they're our first trial with MD Anderson evaluating <unk> in patients with AML.
Speaker Change: Has it been opened has opened for enrollment Lisa will share more details on this shortly.
Raul Rodriguez: Lisa will share more details on this shortly. In summary, the second quarter, we saw record sales of our commercial products, and combined with our cost-effective approach to clinical development, as well as continued financial discipline, we approached net income break-even. This is great progress.
Raul Rodriguez: Lisa will share more details on this shortly. In summary, in the second quarter, we saw record sales of our commercial products, and combined with our cost-effective approach to clinical development, as well as continued financial discipline, we approached net income break-evens. This is great progress. Now, with that, I'll turn the call over to Dave to provide a commercial update. Dave? Thanks, Ray.
Speaker Change: In summary, the second quarter in the second quarter, we saw record sales of our commercial products and combined with our cost effective approach to clinical development as well as continued financial discipline, we approach net income breakeven.
Speaker Change: This is great progress.
David Santos: Now, with that, I'll turn the call over to David to provide a commercial update.
Speaker Change: Now with that I'll turn the call over to David to provide a commercial update David Thanks Raul.
David Santos: David. Thanks, Raoul. Hi, echo Raoul's excitement to be able to bring Devredo to cancer patients as our third marketed target therapy in our commercial portfolio. The successful transition to Raoul was an important step, and we're pleased that we were able to make Devredo available earlier than anticipated. On the left side side, you see how our products have been contributed to our growth over the last 18 months, starting at $23.8 million at the beginning of 2023, to now $33.5 million in Q2 of 24. Pavelese and Reslidia contributed the majority of that growth, reaching a new high of $31.6 million in net product sales in Q2.
David Santos: Raul, I echo Raul's excitement to be able to bring Gabretto to cancer patients as our third marketed targeted therapy in our commercial portfolio. The successful transition to Rigel was an important step, and we're pleased that we were able to make Gabretto available earlier than anticipated.
David: Echo Raul, it's exciting to be able to bring that brand into cancer patients at our third marketed targeted therapy in our commercial portfolio.
David: The successful transition to Rigel was an important step and we're pleased that we were able to make a readily available earlier than anticipated.
David Santos: On the left side of slide 7, you see how our products have contributed to our growth over the last 18 months, starting at $23.8 million at the beginning of 2020 to now $33.5 million in Q2 of 2024. Pavlis and Reslydia contributed the majority of that growth, reaching a new high of $31.6 million in net product sales in Q2. The early Gevretto sales of nearly $2 million added incrementally to our strong portfolio group.
Speaker Change: On the left side of slide seven you see how our products having contributed to our growth over the last 18 months, starting at $23 $8 million at the beginning of 2023 and now $33 $5 million in Q2 of 'twenty four.
Speaker Change: Probably some rest linear contributed the majority of that growth, reaching a new high of $31.6 million in net product sales in Q2.
David Santos: The early Devredo sales of nearly $2 million added incrementally to our strong portfolio growth. The right side of the slide shows how we've generated robust portfolio revenue growth over the past three and a half years. We have grown each quarter's sales over the previous year, and that growth is significantly accelerating. Just a year ago, our total portfolio sales were just under $24 million in Q2, and we are now reporting $33.5 million in net product sales. That's nearly $10 million in incremental sales, representing 40% growth. We're on track to deliver a record year of net product sales in 2024 as our portfolio sales continue to expand in the second half.
Speaker Change: The early give rental sales of nearly $2 million added incrementally to our strong portfolio grids.
David Santos: The right side of the slide shows how we've generated robust portfolio revenue growth over the past three and a half years. We have grown each quarter's sales over the previous year, and that growth is significantly accelerated. Just a year ago, our total portfolio sales were just under $24 million in Q2, and we are now reporting $33.5 million in net product sales.
Speaker Change: The right side of the slide shows how we generated robust portfolio remedy granted over the past three and a half years.
Speaker Change: We have grown each quarter's sales over the previous year and that growth is significantly accelerating.
Speaker Change: Just a year ago, our total portfolio sales were just under $24 million in Q2, and we are now reporting $33 $5 billion of net product sales, that's nearly $10 million in incremental sales representing 40% growth.
David Santos: That's nearly $10 million in incremental sales representing 40% growth. We're on track to deliver a record year of net product sales in 2024 as our portfolio sales continue to expand in the second half. Our commercial team is focused on execution and driving continued momentum for the three products now in our portfolio. Moving to slide eight, I'll first discuss our performance for Tavalisse in a second.
Speaker Change: We're on track to deliver a record year of net product sales in 2024 as our portfolio sales continue to expand in the second half.
David Santos: Our commercial team is focused on execution and driving continued momentum for the three products now in our portfolio.
Speaker Change: Our commercial team is focused on execution and driving continued momentum for the three products now in our portfolio.
David Santos: Moving to slide 8, I'll first discuss our performance for Pavelese in the second quarter. On slide 9, you'll see our FDA-approved indication, which is for adult patients with chronic immune thrombocytopenia or CITP who had an insufficient response to a previous treatment. Moving to slide 10, I'm pleased to report another record-breaking quarterly performance for Pavelese. We generated $26.4 million in net product sales during the second quarter, a 24% increase from the first quarter, and 25% growth over the same period last year. This growth was driven by continued increases in demand. Tobiles achieved its seventh consecutive quarterly record high, with 2,672 bottles shipped to patients and clinics in Q2, representing 8% growth versus Q1 and an 18% increase over the same period last year.
Speaker Change: Moving to slide eight I'll first discuss our performance for top of lease in the second quarter.
David Santos: On slide 9, you'll see our FDA-approved indication, which is for adult patients with chronic immune thrombocytopenia, or CITP, who had an insufficient response to a previous treatment. Moving to slide 10, I'm pleased to report another record-breaking quarterly performance for Tamalea. We generated $26.4 million in net product sales during the second quarter, a 24% increase from the first quarter and 25% growth over the same period last year. This growth is driven by continued increases in demand.
Speaker Change: On slide nine you'll see our FDA approved indication, which is for adult patients with chronic immune thrombocytopenia or C. I T. P who had an insufficient response to a previous treatment.
Speaker Change: Moving to slide 10, I'm pleased to report another record breaking quarterly performance for <unk>, we generated $26 $4 million net product sales during the second quarter at 24% increase from the first quarter and 25% growth over the same period last.
Speaker Change: Yeah.
Speaker Change: This growth was driven by continued increases in demand.
David Santos: Tavalisse achieved its seventh consecutive quarterly record high with 2,672 bottles shipped to patients and clinics in Q2, representing 8% growth versus Q1 and an 18% increase over the same period last year. Slide 11 shows just how our bottle shift to patients and clinics has grown over the last 18 months. And it is depicted in bottles per day, so you can appreciate the acceleration in Q2. That growth from 38.8 bottles per day by 3 bottles per day to 41.8 represents our largest quarter-to-quarter increase in the last two years.
Speaker Change: <unk> achieved its seventh consecutive quarterly record high with 2600, 72 bottles shipped to patients and clinics in Q2, representing 8% growth versus Q1, and an 18% increase over the same period last year.
David Santos: Slide 11 shows just how our bottles shipped to patients and clinics have grown over the last 18 months, and it is depicted in bottles per day so you can appreciate the acceleration in Q2. That growth from 38.8 bottles per day by 3 bottles per day to 41.8 represents our largest quarter-to-quarter increase in the last two years. Even more importantly, we see our daily bottles grow each and every month during Q2. This accelerating growth has been driven by a continuous flow of new patient starts and strong carry over for refills. Overall, we believe this trend boasts very well for the second half of the year.
Speaker Change: Slide 11 shows just how our bottles shipped to patients and clinics have grown over the last 18 months and it is depicted in bottles per day. So you can appreciate the acceleration in Q2.
Speaker Change: That growth from 38.8 barrels per day by three bottles per day to 41.8 represents our largest quarter to quarter increase in the last two years.
David Santos: Even more importantly, we saw our daily bottles grow. Each and every month during Q2, this accelerating growth has been driven by a continuous flow of new patient starts and strong carryover from returns. Overall, we believe this trend bodes very well for the second half of the year. I want to thank the entire team for all their passion and commitment to continue to impact more CITP patients with topical. Moving to slide 12.
Speaker Change: Even more importantly, we see SAR daily bottles CRO.
Speaker Change: Each and every month during Q2 this accelerating growth has been driven by a continuous flow of new patient starts and strong carryover from refills.
Speaker Change: Overall, we believe this trend bodes very well for the second half of the year.
David Santos: I want to thank the entire team for all their passion and commitment to continue to impact more CITP patients with Tobiles.
Speaker Change: I want to thank the entire team for all their passion and commitment to continue to impact more Ti T. P patients with total lease.
David Santos: Moving to slide 12, now I'd like to take a few minutes to discuss our strong quarter growing REST Lydia sales. On slide 13, you'll see our FDA-approved indication for REST Lydia, which is for adult patients with relapsed or refractory acute myeloid leukemia with the susceptible IDH1 mutation as detected by an FDA-approved test. Moving to slide 14, we shipped 424 bottles of REST Lydia to patients and clinics in Q2, representing strong 30% growth versus Q1 of 2024, and again, more than doubling the demand generated in the same period a year ago. Total bottles sold of REST Lydia were 23 bottles less than our bottles shipped to patients and clinics as our distribution channel reduced inventory.
David Santos: Now I'd like to take a few minutes to discuss our strong quarter growing res Lidius. On slide 13, you'll see our FDA-approved indication for Reslydia, which is for adult patients with relapsed or refractory acute myeloid leukemia with the susceptible IDH1 mutation as detected by an FDA-approved test. Moving to slide 14, we shipped 424 bottles of Reslydia to patients and clinics in Q2, representing strong 30% growth versus Q1 of 2024 and again, more than doubling the demand generated in the same period a year ago.
Speaker Change: Moving to slide 12, now I'd like to take a few minutes to discuss our strong quarter growing rents linear sales.
Speaker Change: On slide 13, you'll see our FDA approved indication for Wrestlemania, which is for adult patients with relapsed or refractory acute myeloid leukemia with the susceptible IV H one mutation as detected by an FDA approved test.
Speaker Change: Moving to slide 14, we shipped 424 bottles of Rensselaer he had to patients and clinics in Q2, representing a strong 30% growth versus Q1 of 'twenty 'twenty, four and again more than doubling the demand generated in the same period a year ago.
David Santos: Total bottles sold of Reslydia were 23 bottles less than our bottles shipped to patients and clinics as our distribution channel reduced inventory. This resulted in $5.2 million in second quarter net product sales, doubling compared to a year ago.
Speaker Change: Total bottles sold in Brentwood, and yet were twenty-three bottles less than our bottles shipped to patients and clinics as our distribution channel reduced inventory. This resulted in $5 $2 million in second quarter net product sales doubling compared to a year ago.
David Santos: This resulted in $5.2 million in second quarter net product sales, doubling compared to a year ago. Moving to slide 15, I'm happy to report that since we set out to expand awareness in the community, we have seen a nice uptick in community debate. In fact, in Q2, the community segment represented about a quarter of our overall demand bottles. This clearly demonstrates how this segment can be an important incremental contributor to our overall grip. Since leukemia treaters in the community are comfortable using Venetoclax-based regimens in the front line setting, the Res Lydia post-Venetoclax-stata is particularly meaningful to them.
David Santos: Moving to slide 15, I'm happy to report that since we set out to expand awareness in the community, we have seen a nice uptick in community demand. In fact, in Q2, the community segment represented about a quarter of our overall demand volume. This clearly demonstrates how this segment can be an important incremental contributor to our overall growth. Since leukemia treaters in the community are comfortable using venetoclax-based regimens in the frontline setting, the Reslydia post-venetoclax data is particularly meaningful to them.
Speaker Change: Moving to slide 15, I'm happy to report that since we set out to expand awareness in the community we have seen a nice uptick in community demand.
Speaker Change: In fact in Q2, the community segment represented about a quarter of our overall demand box.
Speaker Change: This clearly demonstrates how this segment can be an important incremental contributor to our overall growth.
Speaker Change: Since leukemia treaters in the community are comfortable using Vanadic class based regimens in the frontline setting there is linear post venetic plaques data is particularly meaningful to them.
David Santos: Overall, we still have a significant opportunity to increase awareness and adoption of REST Lydia across both segments of our business, and we look forward to doing exactly that in the remainder of the year.
David Santos: Overall, we still have a significant opportunity to increase awareness and adoption of Reslydia across both segments of our business, and we look forward to doing exactly that during the remainder of the year. Moving to slide 16, we are so pleased to have completed the NDA transfer of Gevretto to our portfolio. And we are now on our journey to impact even more cancer patients with our third approved targeted therapy. On slide 17, I'll begin by reviewing the FDA-approved indications for Devretto, which include the treatment of adult patients with metastatic, Rett fusion-positive, non-small cell lung cancer, as well as adult and pediatric patients 12 years of age and older with advanced Rett fusion positive thyroid cancer who require systemic therapy and who are radioactive iodide refractory.
Speaker Change: Overall, we still have a significant opportunity to increase awareness and adoption of Wrestlemania across both segments of our business and we look forward to doing exactly that in the remainder of the year.
David Santos: Moving to slide 16, we are so pleased to have completed the NDA transfer of Gabretto to our portfolio. and we are now on our journey to impact even more cancer patients with our third approved targeted therapy. On slide 17, I'll begin by reviewing the FDA-approved indications for DevReno, which includes the treatment of adult patients with metastatic, RET-fusion positive non-small cell lung cancer, as well as adult and pediatric patients 12 years of age and older with advanced RET-fusion positive thyroid cancer who require systemic therapy and who are radioactive iodide refractory. First, I wanted to provide an update on how well the entire Rigel team executed a comprehensive and well-thought-out transition plan.
Speaker Change: Moving to slide 16, we are so pleased to have completed the N D. A transfer of GAAP rent owed to our portfolio. So we are now on our journey to impact EBIT more cancer patients with our third approved targeted therapy.
Speaker Change: On slide 17, I'll begin by reviewing the FDA approved indications for game right now which include the treatment of adult patients with metastatic ret fusion positive non small cell lung cancer as well as adult and pediatric patients 12 years of age and older with advanced Ret fusion positive thyroid cancer, who.
Speaker Change: Requires systemic therapy, and who are radioactive iodine refractory.
David Santos: First, I wanted to provide an update on how well the entire Rigel team executed a comprehensive and well-thought-out transition plan. Slide 18 shows how we were fully ready upon the June 24th NDA transfer to provide both patients and HCPs with all the support needed to help transition patients to Rigel's distribution network and patient services. In terms of patient services, our Rigel OneCare and Copay websites were up and running within two hours of the NDA transfer, and we have now successfully transferred patients to our patient assistance program and Copay.
Speaker Change: First I wanted to provide an update on how well the entire rigel team executing a comprehensive and well thought out transition plan.
David Santos: Slide 18 shows how we were fully ready upon the June 24th NDA transfer to provide both patients and HCPs with all the support needed to help transition patients to Rigel's distribution network and patient services. In terms of patient services, our Rigel One Care and co-pay websites were up and running within two hours of NDA transfer, and we have now successfully transferred patients to our patient assistance program and co-pay program. To further support patients in HCPs, our DevReno and DevReno HCP websites were also up and running within two hours after NDA transfer, and we had updated Rigel-abled prescribing information, dosing and administration guides, distribution information, and co-pay assistance materials ready for the field to use on that day.
Speaker Change: Slide 18 shows how we were fully ready upon the June 24th NDA transfer to provide both patients in hcp's with all the support needed to help transition patients to rifles distribution network and patient services.
Speaker Change: In terms of patient services are rigel, one care and co pay websites were up and running within two hours of NDA transfer and we have now successfully transferred patients to our patient assistance program and co pay program.
David Santos: To further support patients and HCPs, our Givretto and Givretto HCP websites were also up and running within two hours after NDA transit, and we had updated, RIGA-labeled prescribing information, dosing and administration guides, distribution information, and co-pay assistance materials ready for the field to use on that day. They quickly contacted a prioritized list of key accounts, enabling the identification of additional Gibretto patients and prescribers.
Speaker Change: To further support patient that Hcp's argued Reno and get Reno H C. P. Websites were also up and running within two hours. After NDA transfer and we had updated Roger labeled prescribing information dosing and administration guidance distribution information and co pay assistance material.
Speaker Change: Ready for the field to use on that day.
David Santos: And lastly, our field teams across commercial and medical were trained and ready to deliver the VReno availability message directly to their customers to support a successful transition of patients. They quickly contacted a prioritized list of key accounts, enabling the identification of additional DevReno patients and prescribers.
Speaker Change: And lastly, our field teams across commercial and medical were trained and ready to deliver the bran availability message directly to their customers to support the successful transition of patients.
Speaker Change: They quaintly contacted a prioritized list of key accounts, enabling the identification of additional get brito patients and prescribers.
David Santos: Moving to slide 19, I'm incredibly grateful to the entire cross-functional team that worked so closely together over four months with the successful transition. Because of their collective efforts, DevReno officially became commercially available for Rigel on June 27th, and we are extremely proud that our first 3PL shipments went out that day. DevReno was stocked in our distribution channel on June 28th, ahead of our target date of July 1st. Our goal was to ensure both current patients taking DevReno and those newly prescribed continued to have access to DevReno without interruption, and the prescribers can feel confident knowing that their patients can continue getting the therapy they need.
David Santos: Moving to slide 19, I'm incredibly grateful to the entire cross-functional team that worked so closely together over four months with Genentech and Blueprint to ensure the successful transition. Because of their collective efforts, Gevretto officially became commercially available from Rigel on June 27th, and we are extremely proud that our first 3PL shipments went out that day. Giverna was stocked in our distribution channel on June 28th, ahead of our target date of July 1st.
Speaker Change: Moving to slide 19, I'm incredibly grateful to the entire cross functional team that worked so closely together over four months with the Genentech and blueprint teams to ensure the successful transition because of their collective efforts get Reno officially became commercially available from Rachel on June 12.
Speaker Change: Seven and we are extremely proud that our first three PL shipments went out that day.
Speaker Change: <unk> Rana with Stockton, our distribution channel on June 28 ahead of our target date of July one.
David Santos: Our goal was to ensure that both current patients taking Gevretto and those newly prescribed continue to have access to Gevretto without interruption, and that prescribers can feel confident knowing that their patients can continue getting the therapy they need. So far, our teams have more than delivered on that promise, and we applaud them for their exemplary commitment to patient care. And finally, moving to slide 20, you'll see the two sizes of Rigel-labeled bottles that we now have available.
Speaker Change: Our goal was to ensure both current patients taking your bread aisle and those newly prescribed continued to have access to get red oak without interruption and the prescribers can feel confident knowing that their patients can continue getting the therapy they need.
David Santos: So far, our teams have more than delivered on that promise, and we applaud them for their exemplary commitment to patients.
Speaker Change: So far our teams have more than delivered on that promise and we applaud them for their exemplary commission commitment to patients.
David Santos: And finally, moving to slide 20, you'll see the two sizes of Rigel-abled bottles that we now have available. DevReno is available in bottles of either 60 or 90 capsules. And for reporting purposes, we will report the total number of 60 count equivalent bottles as we move forward, which are the number of 60 count bottles sold added to one and a half times the number of 90 capsules. also. And to wrap up, since we exceeded our goal, and Rigel Label product was available earlier than anticipated, in the very last week of the second quarter, we shipped 228 60-count equivalent bottles of Geberetto to initially stock our distribution channel.
Speaker Change: And finally moving to slide 20, you'll see the two sizes of Rigel labeled bottles that we now have a bill.
David Santos: Governo is available in bottles of either 60 or 90 caps. For reporting purposes, we will report the total number of 60-count equivalent bottles as we move forward, which is the number of 60-count bottles sold added to one and a half times the number of 90-count bottles.
Speaker Change: Go Reno is available in bottles of either 60, or 90 capsules and for reporting purposes. We were report the total number of 60 count equivalent bottles as we move forward, which are the number of 60 count bottles sold added to one and a half times the number of 90 count so.
David Santos: And to wrap up, since we exceeded our goal and the ride-to-label product was available earlier than anticipated, in the very last week of the second quarter, we shipped 228 60-calc equivalent bottles of Gevretto to initially stock our distribution channel. This, again, was an outstanding result of flawless execution working with our distribution network to ensure they had completely winded down their existing inventory of product and were fully ready to order, receive, and ship Rigel-labeled give-readys.
Speaker Change: And to wrap up since we exceeded our goal and Roger labeled product wasn't available earlier than anticipated in the very last week of the second quarter. We shipped 228 60 count equivalent bottles of gab read out to initially stock our distribution channel.
David Santos: This, again, was an outstanding result of flawless execution, working with our distribution network to ensure they had completely winded down their existing inventory of product, and we're fully ready to order, receive, and ship Rigel Label to Geberetto. Because of these early shipments to stock our network in June, we have already recorded $1.9 million in net Geberetto revenue. Overall, the Geberetto transition has gone very smoothly, and Rigel Label to Geberetto bottles are now being shipped to patients and clinics each day as planned, just a bit ahead of schedule. Again, I want to express our gratitude to the entire Rigel transition team for working together as one to exceed our goal of ensuring both current and newly prescribed patients continue to have access to Geberetto without interruption.
Speaker Change: This again was an outstanding result of flawless execution working with our distribution network to ensure they had completely winding down their existing inventory of product and we're fully ready to order receive and ship rigel labeled give red.
David Santos: Because of these early shipments to stock our network in June, we have already recorded $1.9 million in net Gevretto revenue. Overall, the Gevretto transition has gone very smoothly, and Rigel-labeled Gevretto bottles are now being shipped to patients and clinics each day as planned, just a bit ahead of schedule. Again, I want to express our gratitude to the entire Rigel transition team for working together as one to exceed our goal of ensuring both current and newly prescribed patients continue to have access to Gabretto without interruption. I look forward to updating you next quarter, and I'll now turn the call over to Lisa to provide an update on our development programs.
Speaker Change: Because of these early shipments to stock our network in June we have already recorded $1.9 billion in net give retro revenue.
Speaker Change: Overall, the game Red Oak transition has gone very smoothly and rigel labeled goodbread bottles are now being shipped to patients and clinics each day as plant just a bit ahead of schedule.
Speaker Change: Again, I want to express our gratitude to the entire rigel transition team for working together as one to exceed our goal of ensuring both current and newly prescribed patients continue to have access to get better without interruption.
Lisa Rojkjaer: I look forward to updating you next quarter, and I'll now turn the call over to Lisa to provide an update on our development programs. Lisa?
Speaker Change: I look forward to updating you next quarter and I'll now turn the call over to Lisa to provide an update on our development programs visa.
Lisa Rojkjaer: Thanks, Dave.
Lisa: Thanks, Dave.
Lisa Rojkjaer: Moving to slide 22, we outline our strategy to continue expanding our hematology and oncology pipeline. First, we're focused on advancing our IDH-1 inhibitor, eluticidinib, into new clinical indications. We believe eluticidinib has potential in several cancers where mutated IDH-1 plays a role, such as additional AML segments, myelodysplastic syndrome, or MDS, and glioma, either as modacerity or in combination. To further evaluate eluticidinib in these indications, we've entered into strategic development collaborations with the MD Anderson Cancer Center and the Connect Cancer Consortium. We are also advancing our R289, our novel Iraq-14 inhibitor, in patients with lower risk MDS.
David Santos: Moving to slide 22, we outline our strategy to continue expanding our hematology and oncology pipeline. First, we're focused on advancing our IDH1 inhibitor, elutacidinib, into new clinical indications. We believe lutecidinib has potential in several cancers where mutated IDH1 plays a role, such as additional AML segments, myelodysplastic syndrome, or MDS, and glioma, either as monotherapy or in combination.
Lisa: Moving to slide 22, we outline our strategy to continue expanding our hematology and oncology pipeline.
Lisa: First we're focused on advancing our I D. H, one inhibitor alyssa sudden it into new clinical indications, we believe lets just sit and it has potential in several cancers, where mutated I D. H one plays a role such as additional AML segments, Myelodysplastic syndrome, or Mds and glioma.
Speaker Change: Hi, there as monotherapy or in combination.
David Santos: To further evaluate lutecidinib in these indications, we have entered into strategic development collaborations with the MD Anderson Cancer Center and the Connect Cancer Consortium. We are also advancing R-289, our novel IRAC1-4 inhibitor, in patients with lower-risk MDS. Enrollment continues to progress in our Phase 1b trial, and we expect to have preliminary data from the first part of this trial later this year. We also remain focused on evaluating potential opportunities to in-license or acquire products that would be a strategic fit for our portfolio.
Lisa Rojkjaer: The role that continues to progress in our phase-1B trial, and we suspect to have preliminary data from the first part of this trial later this year. We also remain focused on evaluating potential opportunities to enlighten or acquire products that would be a strategic sit for our portfolio. We're looking for differentiated products in hematology, oncology, or related areas. Products that are late stage, possibly with registration data, soon to have registration data, or more advanced, and products that can leverage our hematology oncology infrastructure. As demonstrated with our acquisitions of eluticidinib and pro-setinib, our goal is to continue to find assets that align with our organization, pipeline, and ability to execute.
Lisa Rojkjaer: We're looking for differentiated products in hematology, oncology, or related areas; products that are late stage, possibly with registrational data, soon to have registrational data, or more advanced, and products that can leverage our hematology-oncology infrastructure. As demonstrated with our acquisitions of Alutacitinib and Pralacitinib, our goal is to continue to find assets that align with our organization's pipeline and ability to execute on them.
Lisa Rojkjaer: To start off on slide 23, we're very pleased to have a development collaboration with the MD Anderson Cancer Center, internationally renowned for cancer care and academic research, to advance eluticidinib more broadly into AML, MDS, and beyond. Through this partnership, Alutasynib will be evaluated in combination with other agents and newly diagnosed IDH-1 mutated AML patients for the first time, as well as in other myeloid disorders. We also plan to evaluate Alutasynib as a monotherapy in lower risk MDS and CCUS, a condition associated with an increased risk of developing MDS and its close transplant maintenance therapy. That's four clinical trials on the horizon, with up to $15 million paid over five years.
Lisa Rojkjaer: To start off, on slide 23, we're very pleased to have a development collaboration with the MD Anderson Cancer Center, internationally renowned for cancer care and academic research, to advance elutacidin more broadly into AML, MDS, and beyond. Through this partnership, elutucidinib will be evaluated in combination with other agents and newly diagnosed IDH1-mutated AML patients for the first time, as well as in other myeloid We also plan to evaluate elutucidinib as a monotherapy in lower-risk MDS and CCUS, a condition associated with an increased risk of developing MDS, and as post-transplant maintenance therapy. That's four clinical trials on the horizon, with up to $15 million paid over five years. We expect these trials to position us to conduct a subsequent registrational trial or clinical trial.
Lisa: Attrition with the MD Anderson cancer Center internationally renowned for cancer care in academic research to advance the Lucas Sydney more broadly into AML Mds and beyond.
Lisa: Through this partnership allude to sit in that will be evaluated in combination with other agents and newly diagnosed I D. H, one mutated AML patients for the first time as well as in other myeloid disorders.
Lisa: We also plan to evaluate a looser sitting up as a monotherapy in lower risk Mds and Cc U S. A condition associated with an increased risk of developing Mds and its post transplant maintenance therapy.
Speaker Change: That's four clinical trials on the horizon with up to $15 million paid over five years.
Lisa Rojkjaer: We expect these trials to position us to conduct a subsequent registration trial or trials. And I'm excited to share that, as Raul mentioned, the first trial under our research collaboration is now open for enrollment.
Lisa: We expect these trials to position us to conduct a subsequent registrational trial or trials.
Lisa Rojkjaer: I'm excited to share that, as Raul mentioned, the first trial under our research collaboration is now open for enrollment. On slide 24, you'll see that this is a Phase 1b open-label trial that will evaluate the safety and efficacy of a triplet combination regimen of IV or oral dacitabine, phenetoclax, and elutacidinib in patients with IDH1-mutated AML. The focus of the Phase 1B part will be to find a recommended combination dose of docidabine and venetoclax that can be given in combination with eluticidinib to AML patients in Phase 2.
Lisa: And I'm excited to share that as Rahul mentioned, the first trial under our research collaboration is now open for enrollment.
Lisa Rojkjaer: On slide 24, you'll see that this is a Phase 1B open label trial that will evaluate the safety and efficacy of a triple combination regimen of ID or oral decidabene, venetoclax, and alutasynib in patients with IDH-1 mutated AML. The focus of the phase 1B part will be to find a recommended combination dose of decidabene and venetoclax that can be given in combination with alutasynib to AML patients in phase 2. The primary objective in phase 2 is to determine the complete remission rate in newly diagnosed and relapsed refractory patients. As this study will include an oral formulation of decidabene, it has the potential to lead to an all-oral AML combination regimen, which would be an exciting development for patients that are ineligible for intensive chemotherapy.
Rahul: On slide 24, you'll see that this is a phase one be open label trial that will evaluate the safety and efficacy of a triplet combination regimen of IV or oral decitabine, another clocks and dilutive Sydney and patients with I D. H, one mutated AML.
Rahul: The focus of the phase one b part will be to find the recommended combination dose of decitabine and vanilla box that can be given in combination with the looser Sydney to AML patients in phase II the.
Lisa Rojkjaer: The primary objective in phase 2 is to determine the complete remission rate in newly diagnosed and relapsed refractory patients. As this study will include an oral formulation of difidabine, it has the potential to lead to an all-oral AML combination regimen, which would be an exciting development for patients that are ineligible for intensive chemotherapy.
Lisa: The primary objective in phase two is to determine the complete remission rate in newly diagnosed and relapsed refractory patients.
Lisa Rojkjaer: We and MD Anderson are very excited to kick off this trial and look forward to sharing updates as the study progresses.
Lisa Rojkjaer: We and MD Anderson are very excited to kick off this trial and look forward to sharing updates as the study progresses. Moving to slide 25, another important development collaboration we have is with the Connect Consortium to conduct a phase 2 trial in patients with IDH1 mutated glioma. Gliomas account for around 30% of CNS tumors in children, adolescents, and young adults, with approximately one-third of these being high-grade gliomas, translating to approximately 800 to 1,000 new cases each year in the U.S. High-grade gliomas are a leading cause of cancer-related deaths in adolescents and young adults. Despite available therapies, the 5-year survival rate for this population is less than 10%. IDH1 mutations are found in up to 36% of high-grade gliomas in adolescents and young adults.
Lisa Rojkjaer: Moving to slide 25, another important development collaboration we have is with the Kinect Consortium to conduct a Phase 2 trial in patients with IDH-1 mutated glioma. Gliomas account for around 30% of CNS tumors in children, adolescents, and young adults, with approximately one-third of these being high-grade gliomas, translating to approximately 800 to 1,000 new cases each year in the U.S. High-grade gliomas are a leading cause of cancer-related deaths in adolescents and young adults. Despite available therapies, the five-year survival of this population is less than 10%. IDH-1 mutations are found in up to 36% of high-grade gliomas in adolescents and young adults.
Lisa Rojkjaer: Based on results from a phase 1B clinical trial where Alutasynib was evaluated in patients with relapsed or refractory IDH-1 mutated glioma, we believe that Alutasynib has potential in this indication, and Alutasynib will be included in Kinect's target D trial, a molecularly guided phase 2 umbrella clinical trial for high-grade glioma. The goal of this study is to determine whether the combination of Alutasynib and Temizolamide followed by Alutasynib monotherapy can prolong the progression-free survival of patients diagnosed with an IDH-1 mutated high-grade glioma when given after radiotherapy. We anticipate that this trial will be activated in the second half of this year.
Lisa Rojkjaer: Based on results from a Phase 1b clinical trial where elutacidinib was evaluated in patients with relapsed or refractory IDH1-mutated glioma, we believe that elutacidinib has potential in this indication, and it will be included in CONNECT's TARGET-D trial, a molecularly guided Phase 2 umbrella clinical trial for high-grade glioma The goal of this study is to determine whether the combination of elutucicidinib and temozolomide, followed by elutucicidinib monotherapy, can prolong progression-free survival in patients diagnosed with an IDH1-mutated high-grade glioma when given after radiotherapy.
Lisa: To 90, H, one mutated high grade glioma when given after radiotherapy.
Lisa Rojkjaer: We anticipate that this trial will be initiated in the second half of this year. We, along with Connect, are excited about elutacidinib's potential to provide a much-needed new treatment option to this underserved patient population. Next, I'd like to update you on progress from our own clinical development program in lower-risk MDS with our novel dual IRAC1-4 inhibitor, R289. Lower-risk MDS is another area of high unmet needs in a primarily elderly patient population facing progressive cytopenias, particularly anemia, resulting in transfusion dependency, an increased risk of infections, and a risk of progression to acute leukemia. Treatment options for these mostly transfusion-dependent patients are limited.
Lisa: We anticipate that this trial will be activated in the second half of this year.
Lisa Rojkjaer: We, along with Kinect, are excited about a lucidness potential to provide a much-nated new treatment option to this underserved patient population.
Speaker Change: We along with connect are excited about it we just didn't have the potential to provide a much needed new treatment option to this underserved patient population.
Lisa Rojkjaer: Next, I'd like to update you on progress from our own clinical development program in lower-risk MDS, with our novel dual IRAK-4 inhibitor, R289. Lower-risk MDS is another area of high unmet needs, and a primarily elderly patient population faced in progressive cytopenias, particularly anemia, resulting in transfusion dependency and increased risk of infections, and a risk of progression to acute leukemia. Treatment options for these mostly transfusion-dependent patients are limited. In second and later lines of therapy, durable responses are difficult to attain, and toxicity becomes more of an issue. We believe that R289 has the potential to address the unmet needs in this patient population by targeting inflammatory signaling.
Lisa: Next I'd like to update you on progress from our own clinical development program in lower risk Mds with our novel dual Iraq, one four inhibitor are 289.
Lisa: Lower risk Mds is another area of high unmet need and are primarily elderly patient population facing progressive cytopenia, particularly anemia, resulting in transfusion dependency and increased risk of infections and the risk of progression to acute leukemia.
Lisa: Treatment options for these mostly transfusion dependent patients are limited.
Lisa Rojkjaer: In second and later lines of therapy, durable responses are difficult to attain, and toxicity becomes more of an issue. We believe that R289 has the potential to address the unmet needs in this patient population by targeting inflammatory signaling. Dysregulation of the immune and inflammatory signaling pathways is associated with MDS. Chronic stimulation of both the Toll-like and IL-1 receptor pathways involving IRAC-1 and IRAC-4 leads to a pro-inflammatory marrow environment and cytopenia.
Lisa: Second and later lines of therapy durable responses are difficult to attain and toxicity becomes more of an issue.
Lisa: We believe that our 289 has the potential to address the unmet needs in this patient population by targeting inflammatory signaling.
Lisa Rojkjaer: This regulation of the immune and inflammatory signaling pathways is associated with MDS, with chronic stimulation of both the Toll-like and IL-1 receptor pathways, involving IRAK-1 and IRAK-4, leading to a pro-inflammatory marrow environment and cytopenias. Iraq-1 and 4 activation independent of this pathway may also lead to persistent inhibition of somatoquatic cell differentiation. Co-targeting both Iraq-1 and 4 may fully suppress inflammation and restore hematopoiesis in MDS. Clinically, Iraq-4 inhibitors in MDS and AML have thus far only shown modest activity, supporting this concept. In preclinical and healthy volunteer studies, R835, a dual Iraq-1-4 inhibitor, suppressed pro-inflammatory cytokine production.
Lisa Rojkjaer: Irak 1 and 4 activation independent of this pathway may also lead to persistent inhibition of hematopoietic cell differentiation; co-targeting both IRAC1 and IV may fully suppress inflammation and restore hematopoiesis in MDS. However, clinically, IRAC4 inhibitors in MDS and AML have thus far only shown modest activity supporting this concept. In preclinical and healthy volunteer studies, R835, a dual IRAC1-4 inhibitor, suppressed pro-inflammatory cytokine production. R-289 is an oral prodrug that is rapidly converted to R-835 in the gut and is now being evaluated in lower-risk MDS.
Lisa Rojkjaer: R289 is an oral pro-drug that is rapidly converted to R835 in the gut that is now being evaluated in lower risk MDS. R27 shows the design of our ongoing open-label phase-1-B study of R289 in patients with relapsed or fractured lower risk MDS, which has a dose escalation phase with standard 3 plus 3 design and a dose expansion cohort for confirmatory safety. The primary endpoints for this trial are safety and selection of the recommended dose for expansion, and secondary endpoints include response rates and PK. Based on emerging data from the study, we've recently included two additional cohorts with twice-daily dosing regimens for a total now of five dose levels.
Lisa Rojkjaer: Slide 27 shows the design of our ongoing open-label Phase 1b study of R289 in patients with relapsed refractory lower-risk MDS, which has a dose escalation phase with a standard 3 plus 3 design and a dose expansion cohort for confirmatory safety. The primary endpoints for this trial are safety and selection of the recommended dose for expansion, and secondary endpoints include response rates and PK. Based on emerging data from the study, we recently included two additional cohorts with twice daily dosing regimens for a total now of five dose levels.
Lisa Rojkjaer: Study continues to progress well, and enrollment in the fourth dose level of 250 milligrams twice daily is nearing completion. We anticipate that we will present preliminary data from the first part of this trial later this year.
Lisa Rojkjaer: The study continues to progress well, and enrollment in the fourth dose level of 250 mg twice daily is nearing completion. We anticipate that we will present preliminary data from the first part of this trial later this year. Lastly, on slide 28, our RIBK1 inhibitor programs are progressing well with our partner Lilly. RibK1 is implicated in a broad range of inflammatory cellular processes and plays a key role in tumor necrosis factor signaling. Ocaducertibs, our non-CNS penetrant RibPay1 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.
Lisa Rojkjaer: Lastly, on 528, our rib K1 inhibitor programs are progressing well with our partner, Lily. Rib K1 is implicated in a broad range of inflammatory cellular processes and plays a key role in tumor necrosis factor signaling. Obeducer tips are non-CMS penetrant rib K1 inhibitor previously referred to as R552. It is currently being studied in an adaptive phase 2A2B clinical trial and up to 380 patients with active moderate to severe rheumatoid arthritis. Case 2A enrollment of approximately 100 patients is advancing well, with preliminary analysis of the phase 2A results anticipated within the first half of 2025. Our pre-clinical CNS-penetrant RIPK-1 inhibitor program is also progressing toward lead candidate nomination.
Lisa: Lastly, on slide 28, our Red K, one inhibitor programs are progressing well with our partner Lilly.
Lisa: K one is implicated in a broad range of inflammatory cellular processes and plays a key role in tumor necrosis factor signaling.
Speaker Change: Oh can do searches are non CNS penetrant repay one inhibitor previously referred to as our five five to <unk>.
Lisa: Currently being studied in an adaptive phase two way to be clinical trial and up to 380 patients with active moderate to severe rheumatoid arthritis.
Lisa Rojkjaer: Phase 2A enrollment of approximately 100 patients is advancing well, with preliminary analysis of the Phase 2A results anticipated within the first half of 2025. Additionally, our preclinical CNS penetrant RIPK1 inhibitor program is also progressing toward lead candidate nomination. We're excited about the progress of our programs and their broad potential in rheumatoid arthritis and other immune and CNS diseases. Now, I'll pass the call to Dean to discuss our financial results for the quarter.
Speaker Change: I used to I enrollments of approximately 100 patients is advancing well with preliminary analysis of the phase Iia results anticipated within the first half of 'twenty or 'twenty five.
Lisa: Our preclinical CNS penetrant repay one inhibitor program is also progressing towards lead candidate nomination.
Lisa Rojkjaer: We're excited about the progress of our programs and their broad potential in rheumatoid arthritis and other immune and CNS diseases.
Lisa: We're excited about the progress of our programs and their broad potential in rheumatoid arthritis, and other immune and CNS diseases.
Dean Schorno: Now, I'll pass the call to Dean to discuss our financial results for the quarter.
Dean Schorno: Thank you, Lisa. I'm on slide number 30. During the second quarter, we shipped 2,722 bottles of tablilis to our specialty distributors. Additionally, 2,672 bottles of tablilis were shipped to patients and clinics, while 50 bottles increased the levels remaining in our distribution channels at the end of the quarter. During the second quarter, we shipped 401 bottles of Rosalidia to our specialty distributor. 424 bottles of Virzolinia were shipped to patients and clinics, while 23 bottles decreased the levels remaining on our distribution shelves at the end of the quarter. In the last week of the second quarter, we shipped 220 bottles of Gavretto to our specialty distributors. As Dave mentioned, Gavretto is available in 60-count and 90-count bottles.
Speaker Change: Now I'll pass the call the team to discuss our financial results for the quarter.
Dean Schorno: Thank you, Lisa. I'm on slide number 30. During the second quarter, we ship 2,722 bottles of tablets to our specialty distributors. 2,672 bottles of tablets were shipped to patients at clinics, while 50 bottles increased the levels remaining in our distribution channels at the end of the quarter. During the second quarter, we ship 401 bottles of Resolidia to our specialty distributors. 424 bottles of resolidia were shipped to patients at clinics, while 23 bottles decreased the levels remaining in our distribution channels at the end of the quarter. In the last week of the second quarter, we ship 220 bottles of Redo specialty distributors.
Speaker Change: Thank you Lisa I'm on slide number 30 during the second quarter, we shipped 2722 bottles of Tom we're used to our specialty distributors 2000, and 672 bottles of probably were shipped to patients at clinics.
Speaker Change: The bond was increase the levels remaining in our distribution channels, which ended the quarter.
Dean Schorno: As Dave mentioned, Redo is available in 60-count and 90-count bottles. For reporting purposes, we'll report the number of 60-count equivalent bottles. We reported net product sales from top of the list of $26.4 million in the second quarter, both of 24% compared to $21.3 million in the same period in 2023. We reported net product sales of Resolidia, a $5.2 million in the second quarter, a growth of 102% compared to $2.6 million in the same period in 2023. And finally, we reported net product sales from Get Redo at $1.9 million in the second quarter. Our net product sales from top of the list, Resolidia and Get Redo will recorded net investment discounts, chargebacks, rebates, returns, copay assistance, and other allowances of $15.5 million.
Dean Schorno: For reporting purposes, we'll report the number of 60-count equivalent bottles. We reported net product sales and top lease of $26.4 million in the second quarter, a growth of 24% compared to $21.3 million in the same period last year. We reported net product sales of Reslydia of $5.2 million in the second quarter, a growth of 102% compared to $2.6 million in the same period last year. And finally, we reported net product sales from GetRed at $1.9 million in the second quarter.
Dean Schorno: For the second quarter of 2024, our gross net adjustment for Tavuiz, Spesslitti, and Gabretto was approximately 34%, 23%, and 23% of gross product sales, respectively. Before we move on to Net Product Sales, let me review our expectations for the third quarter. We're pleased with the strength of our business and expect to see continued strength in our year-over-year Net Product Sales growth rate. For the third quarter, we expect our gross net adjustment for Tavolis, Resolene, and Gavretto to be approximately 35%, 23%, and 26% of gross product sales per step. Moving on to the next slide.
Dean Schorno: For the second quarter of 2024, our growth in net adjustment for top of the list, Resolidia and Get Redo was approximately 34%, 23% and 23% of gross product sales respectively.
Dean Schorno: Before we move on from net product sales, let me review our expectations for the third quarter. We're pleased with the strength of our business and expect to see continued strength in our year-over-year net product sales growth rate. For the third quarter, we expect our growth in net adjustment for top of the list, Resolidia and Get Redo to be approximately 35%, 23% and 26% of gross product sales respectively.
Dean Schorno: Under the next slide, in addition to net product sales, our contract revenues from collaborations were $3.4 million in the second quarter. Contract revenues from collaborations consisted of $2.2 million from TSA, $1.1 million from GRIFFELS, and $100,000 from Betaside.
Dean Schorno: In addition to net product sales, our contract revenues from collaborations were $3.4 million in the second quarter. These revenues consisted of $2.2 million from Kise, $1.1 million from Griffles, and $100,000 from MediSign. Moving on to cost and expenses, our cost of product sales was approximately $2.8 million for the second quarter of 2024. Total cost and expenses were $36.4 million, compared to $32.2 million in the same period for 2020, an increase in cost and expenses.
Dean Schorno: Moving on to cost and expenses, our cost of product sales was approximately $2.8 million for the second quarter of 2024. Total cost of expenses were $36.4 million compared to $32.2 million in the same period for 2020. 2003. Increase in cost and expenses, partly due to higher cost of product sales, driven primarily by higher amortization, ventangibles, and royalties. Increased personnel-related costs, and increased research and development costs due to the progress of our clinical activities, including our R289 IRAC-14 inhibitor program. We ended according to cash, cash equivalents, and short-term investments of $49.1 million. We looked to maintain our focus and discipline financial approach in the future.
Speaker Change: Moving on to cost and expenses our cost of product sales was approximately $2 $8 million for the second quarter of 2024 total costs and expenses were $36 4 million compared to $32 $2 million in the same period for 2023.
Speaker Change: The increase in costs and expenses, partly due to higher cost of product sales driven primarily by higher amortization of intangibles and royalties increased personnel related costs and increased research and development costs due to the progress of our clinical activities, including our our 289, Iraq <unk> four inhibitor.
Dean Schorno: Partly due to higher costs of product sales driven primarily by higher amortization of intangibles and royalties, increased personnel-related costs, and increased research and development costs due to the progress of our clinical activities, including our R289-IRAC1-4 inhibitor program. We ended the quarter with cash, cash equivalents, and short-term investments of $49.1 million. We look to maintain our focused and disciplined financial approach into the future. With that, I'd like to turn the call back over to Raul. Thank you, Dean.
Speaker Change: Program.
Rob Rowe: We ended the quarter with cash cash equivalents and short term investments of $49 $1 million, we look to maintain our focused and disciplined financial approach into the future with that I'd like to turn the call back over to Rob Rowe. Thank you Dean to conclude this this was a very good quarter for Rigel, we made significant progress with <unk>.
Raul Rodriguez: With that, I'd like to turn the call back over to Raul. Raul.
Raul Rodriguez: Thank you, Dean. To conclude, this was a very good quarter for Rachel. We make significant progress across all areas of our hematology and oncology business, including commercial product sales and portfolio, our development pipeline, and our financial position.
Raul Rodriguez: To conclude, this was a very good quarter for Rigel. We made significant progress across all areas of our hematology oncology business, including commercial product sales and portfolio, our development pipeline, and our financial position. For each of these areas, I will summarize the quarter and share our outlook.
Rob Rowe: All areas of our hematology oncology business, including commercial product sales and portfolio.
Rob Rowe: Our development pipeline and our financial position.
Raul Rodriguez: For each of these areas, I will summarize the quarter and share our outlook. First, we are delighted with the growth of our commercial business. We achieve record sales for both TavaLis and Rizlidium, and we added a third product, Gavirino, to our commercial portfolio. As we look at it to the second half of 2024, we are focused on continually this sales momentum, positioning us for meaningful growth on the top line. We will also continue to evaluate additional in-licensing deals and acquisitions as we did with Rizlidium and Gavirino, both great acquisitions to Rizl's product portfolio that utilize our sales and medical affairs organizations and expertise.
Rob Rowe: For each of these areas I will summarize the quarter assure I will share our outlook.
Raul Rodriguez: First, we are delighted with the growth of our commercial business. We achieved record sales for both Tavalisse and Rizzolidia. And we added a third product, Gabaretto, to our commercial portfolio. As we look into the second half of 2024, we are focused on continuing this sales momentum, positioning us for meaningful growth on the top line. We will also continue to evaluate additional licensing deals and acquisitions, as we did with Resilien and Cabrero, both great acquisitions to Rigel's product portfolio that utilize our sales and medical affairs organizations and expertise.
Rob Rowe: First we are delighted with the growth of our commercial business, we achieved record sales for both top of Lisa Edwards with you and we added a third product to our commercial portfolio.
Raul Rodriguez: Our development pipeline continues to progress with our 289 in lower risk MDS. We expect to generate preliminary data from our Phase 1B trial by the end of the year.
Raul Rodriguez: Our development pipeline continues to progress with R289 and lower-risk MDS, and we expect to generate preliminary data for our Phase 1B trial by the end of the year. We are also tremendously excited about opening for enrollment the first trial with our strategic collaborator, MD Anderson Cancer Center, to generate additional data on olacutinib in patients with AML. We look forward to initiating additional olacutinib clinical trials with our strategic collaborators and evaluating other opportunities for expanding the development of all our products.
Raul Rodriguez: We are also tremendously excited about that we have open our for enrollment the first trial with our strategic collaborator, MD Anderson Cancer Center, to generate additional data on all the suit and patients with AML. We look forward to activating additional all the suit and clinical trials with our strategic collaborators and to evaluate other opportunities for expanding the development of all our products.
Raul Rodriguez: Finally, financial discipline remains key to our corporate strategy. As our top line grows, we are approaching financial break-even. This enables us to reinvest in our business, advance current and new pipeline programs, and pursue opportunities to expand our portfolio.
Raul Rodriguez: Finally, financial discipline remains key to our corporate strategy. As our top line grows, we are approaching financial breakeven, which enables us to reinvest in our business, advance current and new pipeline programs, and pursue opportunities to expand our portfolio. With that, I thank you for your interest in our progress in the second quarter, and we will now open the call to your questions.
Raul Rodriguez: With that, I thank you for your interest in our progress in the second quarter, and we will now open the call to your questions.
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Operator: 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. You may press star 2 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 start key. Our first question comes from Yigal Nochomovitz with Citi. Please state your question.
Unknown Executive: For participants using speaker equipment, it may be necessary to pick up your handset before pressing a star key.
Yigal Nochomovitz: Our first question comes from Yigal, the Chumovitz, with city. Please state your question. Hi, great. Thank you for taking the question. I just had a few on the Iraq one for dose escalation. You mentioned that you added those levels four and five twice daily dosing, and there was some emerging data that led to those new cohorts. Could you expand a bit on the reasons for those new cohorts? Great.
Yigal Nochomovitz: Hi, great. Thank you for taking the questions. I just had a few. On the IRAC-1.4 dose escalation, you mentioned that you added dose levels 4 and 5 twice daily dosing, and there was some emerging data that led to those new cohorts. Could you expand a bit on the reasons for those new cohorts?
Lisa Rojkjaer: Yeah, thanks. Go ahead, Lisa.
Lisa Rojkjaer: Thank you. Thanks for the question. Yeah, I mean, as you know, the focus for the study is really to be able to determine the optimal dose for phase two expansion, and it's based, you know, we're evaluating safety, PK, preliminary efficacy, and we want to be sure that we thoroughly explore all potential combinations.
Lisa Rojkjaer: Thank you. Thanks for the question. Yeah, I mean, as you know, the focus of this study is really to be able to determine the optimal dose for phase two expansion. And it's based on, you know, we're evaluating safety, PK, preliminary efficacy, and we want to be sure that we thoroughly explore all potential combinations. So in terms of the options in terms of once daily and twice daily dosing, you'll hopefully be seeing the data at the end of the year.
Lisa Rojkjaer: So, in terms of the or options in terms of once daily and twice daily dosing. So you'll be hopefully seeing the data at the end of the year.
Rob Rowe: Seeing the data at the end of the year.
Unknown Executive: Okay, thanks.
Yigal Nochomovitz: Okay, thanks. And then for the MD Anderson collaboration, I noticed that several years ago, actually, also through MD Anderson, there was an investigator-sponsored study, it was featured at ASCO, with ibucidinib, metoclax, and azacitidine, which showed around a 67% response rate. Just curious, you know, just broadly speaking with this study, what is the goal in terms of what you want to see to be competitive with this triple combination, you know, both in the newly diagnosed and relapsed refractory once you get that far?
Speaker Change: Okay. Thanks, and then for the MD Anderson collaboration I noticed that several years ago actually also through M. D. Anderson. There was an investigator sponsored study was featured at <unk> with I was sitting at a meta clocks and Ava side of Dean.
Unknown Executive: And then for the MD Anderson collaboration, I noticed that several years ago actually also through MD Anderson, there was an investigator-sponsored study. It was featured at ASCO with I was sitting at Metaclacks in Avis, Ida Dean, which showed around a 67% response rate. Just curious, you know, just broadly speaking with this study, what is the goal in terms of what you want to see to be competitive with this triple combination, you know, both in the newly diagnosed and relapsed refractory once you get that far? Yeah, again, thanks to the question. Well, as you know, you know, eluticinib and eluticinib are different combinations.
Rob Rowe: Which showed around a 67%.
Speaker Change: Response rate just curious just broadly speaking with this this study what is the goal in terms of what you want to see to be competitive with this triple combination.
Speaker Change: You know both in the newly diagnosed and relapsed refractory once you get get that far.
Lisa Rojkjaer: Yeah, again, thanks for the question. Well, as you know, elutacidinib and evosidinib are different combinations. Elutacidinib is also a selective IDH1 inhibitor that has a different size and potentially different binding properties than evosidinib, and so we're evaluating it in its own right. I mean, we're encouraged by the preliminary data that have been presented before, but, you know, we also have seen potentially higher efficacy in some of the patient populations in our HEIM-101 studies.
Speaker Change: Yeah again, thanks for the question.
Alicia: As you know you know Alicia and elicit Navarre different combinations.
Lisa Rojkjaer: Eluticinib is also a selective IDH-1 inhibitor that has a different size and potentially different binding properties than Eluticinib. And so we're evaluating it in its own right. I mean, we're encouraged by the preliminary data that have been presented before, but you know, we also have seen potentially higher efficacy in some of the patient populations in our HEM 101 studies. So we'd like to continue to evaluate eluticinib also in this setting, and also particularly, you know, potentially with an oral decidabene regimen.
Speaker Change: It is also.
Speaker Change: Selected by the H one.
Speaker Change: Inhibitor that has a different size and potentially different binding properties than the name of fitness and.
Speaker Change: So we're evaluating it in its own right I mean, we're encouraged by the preliminary data that have been presented before us.
Speaker Change: We also have seen.
Lisa Rojkjaer: And so we'd like to continue to evaluate elutacidinib also in this setting and also, particularly, you know, potentially with an oral dacitabine regimen, as I mentioned, that could lead to a novel oral triplet therapy, which would be really nice to have for, you know, particularly these elderly patients that are not eligible for intensive therapy.
Lisa Rojkjaer: As I mentioned, that could lead to a novel oral triplet therapy, which would be really, you know, nice to have for, you know, particularly these elderly patients that are not eligible for intensive therapies.
Unknown Executive: Okay, thanks. And then just one more on the commercial picture.
Yigal Nochomovitz: Okay, thanks. And then just one more on the commercial picture. I'm just curious, Dean and Raul, is there a point where you guys, now that you have a, you know, fairly established commercial portfolio, is there a point where you would be, and you're getting to break even, which is great, is there a point where you would start to feel comfortable with providing some sort of revenue guidance for the company in the coming years?
Raul Rodriguez: I just curious, Dean and Role, are you planning it? Now that you have a fairly established commercial portfolio, is there a point where you'd be, and you're getting to break even, which is great? Is there a point where you would start to feel comfortable with providing some sort of a revenue guidance for the company in the coming years? Thanks.
Raul Rodriguez: Thanks for the question. You know, the business is solidifying, and there are a couple new additions to the business, while Lydia and Gabriela really contributed tremendously. Again, new product launches, so it's a little more difficult to forecast those. But I think giving guidance is something we evaluate on a regular basis and will continue to do so. And in the future, I certainly see us doing it. But I can't be specific in terms of the timing.
Raul Rodriguez: Thanks for the question. You know, we, the business is solidifying, and a couple of new additions to the business for as linear and Gabretto, really contributed tremendously.
Raul Rodriguez: Again, new product launches, so it's a little more difficult to forecast those. But I think, I think giving guidance is something we evaluate on a regular basis, and we'll continue to do so. And in the future, I certainly see us doing it. I can't be specific on terms of the time you know.
Raul Rodriguez: Okay, thank you. Now, one thing you mentioned there that I think is important to highlight is that really, we're at a point where we're reaching financial break even, that is net income break even or close to it. That's a really great achievement for the business. It allows us to, in the future, generate cash. And that cash, we hope to deploy to generating additional clinical trials for Aluda and R289 in particular, where we see great opportunities.
Raul Rodriguez: Okay, thank you. Now, one thing you mentioned there that I think is important to highlight is that really, we're at a point where we're reaching financial break even, that is, net income break even or close to it. That's a really great achievement for the business. It allows us to, in the future, generate cash. And that cash, we hope to deploy to generating additional clinical trials for ELUDA and R289 in particular, where we see great opportunities, and we'd like to share that with you in the future, but not that distant future.
Raul Rodriguez: And we'd like to share that with you in our investor-based, in the future. But not that distant in the future. Thanks, Rol.
Kristen Kluska: Thank you, and our next question comes from Kristen Kluska with Cantor. Please.
Operator: Thank you. And our next question comes from Kristen Kluska with Kantor. Please state your question.
David Santos: Hi, good afternoon. Congrats on a great quarter here. So, for Tavillese, you know, quarter over quarter, you continue to attribute some of the growth to new patients' starts. So, can you give us a sense of what the key drivers for these new patients' starts? Are there patients that aren't responding to other treatments? Is it physicians or treating some patients to Tavillese getting comfortable prescribing others? And are you seeing earlier line usage in that mix as well?
Kristen Kluska: Hi, good afternoon. Congratulations on a great quarter here. So for Tavalese, you know, quarter over quarter, you continue to attribute some of the growth to new patient starts. So can you give us a sense of what the key drivers are for these new patient starts? Are they patients that aren't responding to other treatments? Is it that physicians are treating some patients with Tavalese and getting comfortable prescribing others? And are you seeing earlier line usage in that mix as well?
David Santos: Dave, would you take a look? Sure, Kristen, thanks for the question. As we talked about last quarter, I didn't give you the numbers, but clearly I said that our new patients' starts were increasing. And, you know, on a quarterly basis, if you look at the slides from last quarter, and, you know, that is what we're focused on. We are focused on growing both our breadth of prescribers; in other words, folks who still, after all these years, haven't tried Tavillese yet, yet they see ITP patients, and then secondly, are depth within prescribers. And I think if you look at our business, we're getting both, you know, new prescribers still make up a pretty significant number of our new patients' starts.
David Santos: Kristen, thanks for the question. As we talked about last quarter, I didn't give you the numbers, but clearly, I showed that our new patient starts were increasing on a quarterly basis if you look at the slides from last quarter. That is what we're focused on. We are focused on growing both our breadth of prescribers, in other words, folks who, after all these years, haven't tried Tavalese yet, yet they see ITP patients, and then, secondly, our depth within prescribers. And I think if you look at our business, we're getting both.
David Santos: You know, new prescribers still make up a pretty significant number of our new patient starts. And in terms of line-of-therapy, the second part of your question, I shared that a couple quarters ago about how we, in our ROC data, are getting more earlier line patients. We continue to look at that. It's a subset of patients that are out there, but it continues to look very good for earlier-line patients. So I think what you're seeing is a combination of both of these things.
David Santos: And in terms of line of therapy, the second part of your question, I shared that a couple quarters ago about how we, in our Roth data, we're getting more earlier line patients. We continue to look at that. It's a subset of patients that are out there, but it continues to look very good for earlier line patients. So I think what you're seeing is both of these things. New patients keep coming in. Their carryover keeps coming in months after month, quarter after quarter, and our sales keep growing. And that's what we're going to continue doing. And I can tell you, you know, now been here for four years.
Kristen Kluska: New patients keep coming in, their carryover keeps coming in month after month, quarter after quarter, and our sales keep growing. And I can tell you, I've now been here for four years. This is something we've been focused on, especially during the last couple of years. And I think that's when you've seen our growth, particularly post-COVID timeframe.
David Santos: This is something we've been focused on, especially during the last couple of years. And I think that's when you've seen our program, particularly post the COVID timeframe. Okay, thanks for that.
Raul Rodriguez: Okay, thanks for that. And then you've clearly built a sales force that can work on all three drugs. But how should we think about how you're going to balance financial discipline with potential new indications or strategies? Should we expect more deals similar to what you did with Pharma and Blueprint that are more sparing to the balance sheet initially and give you time to really generate sales there? Thanks again.
David Santos: And then you've clearly built a sales force that can work on all three drugs.
Speaker Change: Clearly built a sales force that can work on all three drugs, but how should we think about how you're going to balance financial discipline with potential new indications or strategy should we expect more deals similar to what you did with form a blueprint that are more sparing to the balance sheet. Initially and gives you time to.
Raul Rodriguez: But how should we think about how you're going to balance financial discipline with potential new indications or strategies? Should we expect more deals similar to what you did with form of blueprint that are more sparing to the balance sheet? Initially, and give you time to really generate the sales there. Thanks again. Olivia, let me thank you, Chris. I appreciate the question. You know, these two products have really contributed tremendously to our portfolio. And their effect is that it would be provide incremental sales. But importantly, because they leverage the current existing organization, a good deal of the sales post cost of goods does drop down to the bottom line once the product is in our portfolio and fully launched.
Speaker Change: Really generate the cells there thanks again.
Raul Rodriguez: Well, let me thank you, Kristen. I appreciate the question. You know, these two products have really contributed tremendously to our portfolio, and their effect is that they provide incremental sales. But importantly, because they leverage the current existing organization, a good deal of the sales post cost of goods does drop down to the bottom line once the product is in our portfolio and fully launched. And that's a tremendous value in terms of the financial impact they have. So we look to continue to do additional deals going forward. I can't give you specific timeframes for a deal, other than to say it will be in HEMOC.
Olivia: Olivia thank.
Speaker Change: Thank you Richard I appreciate the question.
Speaker Change: These two products have really contributed tremendously to our portfolio and they are effective.
Speaker Change: That would be provided incremental sales, but importantly, because they leverage the current existing organization a good deal of the of the sales post cost of goods does dropdown to the bottom line. Once the product is in our portfolio and it's fully launched and that's a tremendous value in terms of the financial impact they have.
Raul Rodriguez: And that's a tremendous value in terms of the financial impact they have. So we look to continue to do additional deals going forward. I can't give you specific timeframes for a deal other than to say it will be in Hemlock. That's what we're focused on. It'll be a product that leverages our current capabilities. And it'll be a product that will be near term onto the market, because that's where we get the most value. Not like these two products. And I think we are constantly evaluating out there what is available and where we can use our capabilities to add value to products that we may bring in later.
Speaker Change: So we look to continue to do additional deals going forward I can't give you a specific time frames for a deal other than to say it will be in hemo. That's what we're focused on it'll be a product that leverages, our current capabilities and it'll be a product that will be near term onto the market because that's where we get the most valuable looked like these two products.
Raul Rodriguez: That's what we're focused on. It'll be a product that leverages our current capabilities, and it'll be a product that will be released near term into the market because that's where we get the most value, a lot like these two products. And I think we are constantly evaluating what is available and where we can use our capabilities to add value to products that we may bring in later. So I think, you know, they provide tremendous growth opportunities. Incremental to that will be in the longer, longer term as we do additional trials in other areas.
Speaker Change: And I think we are constantly evaluating out there what is available and and where we can use our capabilities to add value to products that we may bring in later, so I think they provide tremendous growth opportunities incremental to that will be in the longer longer term as we do additional trials in other areas.
Raul Rodriguez: So I think, you know, they provide tremendous growth opportunity. Incremental to that will be in the longer, longer term as we do additional trials in other areas. We hope to have the same organization sell our 289 or other indications for Reslidia and AML, MDS, and other areas.
Speaker Change: We hope to have the same organization. So our two week nine or other indications for Reds video and AR in AML.
Speaker Change: M L M D S in other areas.
David Santos: I just want to add that through this time, we've also focused efforts both in the community and institutional segments, so we've got different teams out there. But I just want to point this out because I think your question is a really good one, Carly.
David Santos: Raul. Sorry, I just find out that, you know, through this time we've also, you know, focused efforts both in the community and institutional segments, so we've got, you know, different teams out there.
David Santos: But I just want to point out, because I think your questions are really good ones, Kristen. 20 months ago, we had one product; 20 months ago, we had one product. And so for the last year and a half that we've had two, and we've really learned a lot about managing a couple of different products in the portfolio. And I think we put all of that to great use in these last four months. I mean, over four months, they just learned about this less than five months ago. And here we are booking sales in June. And what we think is a very strong transition with our third product.
David Santos: 20 months ago, we had just one product. And so for the last year and a half, we've had two, and we've really learned a lot about managing a couple of different products in the portfolio. I think we have put all of that to great use in these last four months. I mean, over four months, they just learned about this less than five months ago. And here we are, booking sales in June and what we think is a very strong transition with our third product. So I think our team, what I wanna really talk about here is just...
David Santos: So I think our team, what I want to really talk about here is just our team's ability to execute on different priorities, has really, really matured and solidified over time.
David Santos: And so that's why we have confidence that we can bring in even a more complex product portfolio that our team will execute on.
Unknown Executive: Thanks so much.
Unknown Executive: And a reminder to the audience, please press star one on your phone to cure for a question. To remove yourself from the queue, press star two.
Operator: Thank you, Chris. And a reminder to the audience- Star One.
Operator: Thank you. Thank you all for a great day. Thank you. Our next question comes from Farzin Haque, with Jeff...
Farzin Haque: Our next question comes from Farson Hach with Jeffries. Please state your question. There's a storm on these coasts.
Operator: There's a storm on the East Coast.
Operator: We'll move on to the next question, and our next question comes from Joe Pantginis with HC Wainwright. Please state your question.
Unknown Executive: We'll move on to the next question.
Joe Pancinus: And our next question comes from Joe Pancinus with HC Wainwright. Please state your question. Everybody, good afternoon. Thanks, taking the question. And yeah, it's coming down real hard right now. So some breaking news that I want to ask about and the impact on a loose sitnip. So before the market closed today, the FDA approved a Boris sitnip for glioma. So I wanted to ask with regard to, you know, the potential impact on your study plans as well as potential differentiation.
Joe Pantginis: Everybody, good afternoon. Thanks for taking the question. And yeah, it's coming down real hard right now. Some breaking news that I want to ask about and the impact on elucidinib. So before the market closed today, the FDA approved voracidinib for glioma. So I wanted to ask with regard to, you know, the potential impact on your study plans, as well as potential differentiation.
Lisa Rojkjaer: Sure, I'll ask Alisa and maybe Dave to comment on a bad question. Yeah, thanks for the question, Joe. So yeah, so Boris and, as you mentioned, got approved in patients with grade two glioma, as in patients that have only received surgery. As you know, for a sitnip, it would say dual IDH-1, 2 inhibitor. They've positioned it currently, you know, very early in treatment.
Raul Rodriguez: Sure, I'll ask Lisa and maybe Dave to comment on that question.
Lisa Rojkjaer: Yeah, thanks for the question, Joe. So, Voracidinib, as you mentioned, got approved in patients with grade 2 glioma, as in patients that, you know, that have only received surgery. As you know, Voracidinib is a dual IDH1-2 inhibitor. They've positioned it currently, you know, very early in treatment. We are already, through our collaboration with Connect, we have an ongoing, now it's going to be a global study, positioned in the maintenance setting following radiotherapy.
Lisa Rojkjaer: We are already, with our, through our collaboration with Connect, we have an ongoing now. It's going to be a global study positioned in the maintenance setting, following radio therapy. So patients would have received surgery, radiation, and then they're going to receive telemedicine combination with the loose sitnip for a year, and then a second year looking at a PFS primary endpoint. And aside from that, we're also looking at other potential settings, potentially a bit later in line than the boards in it. So, from our perspective, it hasn't really interfered with our evaluation.
Lisa Rojkjaer: So patients would have received surgery, radiation, and then they're going to receive Temozolomide in combination with Eluticidinib for a year, and then a second year looking at a PFS primary endpoint. And besides that, we're also looking at other potential settings.
Unknown Executive: Unknown Executive, Farzin Haque, Nalin Tejavibulya, Rigel Pharmaceuticals Inc
Unknown Executive: And I would just say... Go ahead; sorry.
Raul Rodriguez: I would just say, Joe, that, you know, BoricidNymphs' data and BoricidNymphs' approval are really great for us. I mean, it proves that IDH plays a key role in gliomas, and these are very difficult to treat patients and tumors. And you know, this is exactly why the World Health Organization changed to, you know, when you look at grade three and grade four gliomas, you know, IDH mutations are key to that.
David Santos: I would just say, Joe, that Boris Hiddim's data and Boris Hiddim's approval are really great for us. I mean, it proves that IDH plays a key role in gliomas, and these are very difficult-to-treat patients and tumors. And, you know, this is exactly why the World Health Organization changed to, you know, when you look at grade 3 and grade 4 gliomas, you know, IDH mutations are key to that. And I think this is proof in principle that IDH inhibitors work, and that's why we're really excited about having Illudis Inhibitor in our portfolio. And needless to say, Joe, I think there are opportunities.
Raul Rodriguez: And I think this is proof in principle that IDH inhibitors work, and that's why we're really excited about to have Elizabeth Arn in our portfolio.
Raul Rodriguez: And needless to say, Joe, I think there are opportunities beyond the more significant approval and label that I think we're exploring, and there are obviously differences between that molecule and our molecule that I think, you know, as we explore that further, we'll highlight for you.
Raul Rodriguez: And, needless to say, Joe, I think there's opportunities beyond the BoricidNymph approval and labels that I think we're exploring, and there are obviously differences between that molecule and our molecule that I think, you know, we, as we explore that further, will highlight for you. Great.
Unknown Executive: Thank you, guys. Thank you.
Unknown Executive: And there are no further questions at this time.
Operator: 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.
Raul Rodriguez: I would like to turn the floor back over to Mr. Raul Rodriguez for closing comments. Well, thank you, everyone. In closing, I'd like to thank you for joining us on this call and for your continued interest in Rajul and our progress. And as always, I'd like to thank our employees for their continued commitment to improving the lives of patients. As every single day counts, and every single day, we have to make their lives better as well. So, thank you for that, and look forward to updating you on our future progress on other calls.
Raul Rodriguez: Well, thank you, everyone. In closing, I'd like to thank you for joining us on this call and for your continued interest in Rigel and our progress. And, as always, I'd like to thank our employees for their continued commitment to improving the lives of patients, as every single day counts, and every single day, we have to make their lives better as well. So, thank you for that, and look forward to updating you on our future progress on other calls. Have a great day, everyone!
Unknown Executive: Have a great day, everyone.
Operator: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
Unknown Executive: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your part-