Q2 2021 Rigel Pharmaceuticals Inc Earnings Call

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Greetings and welcome to Rigel Pharmaceuticals Financial conference call for the second quarter 'twenty 'twenty 1.

Unknown Executive: Greetings, and welcome to Rigel Pharmaceuticals' financial conference call for the second quarter of 2021. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. When required, please press star zero on your telephone keypad.

At this time all participants are in a listen only mode.

A brief question and answer a Shaw for fall presentation.

Spent 1 require operator assistance. Please press star zero on your telephone keypad.

As a reminder, this conference is being recorded.

Unknown Executive: As a reminder, this conference is being recorded. It is now my pleasure to introduce our first speaker, Dolly Vance, who is Rigel's Executive Vice President, Corporate Affairs, and General Counsel. Thank you, Ms. Vance.

It is now my pleasure to introduce our first speaker Dolly Vance, who is Rigel executive Vice President Corporate Affairs and General Counsel. Thank you Ms. Vance you may begin.

Dolly Vance: You may begin. Welcome to our second quarter 2021 financial results and business update conference call. The financial press release for the second quarter was issued a short while ago and can be viewed, along with the accompanying slides for this presentation, in the News and Events section of our Investor Relations page on our website, www.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. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted.

Welcome to our second quarter, 2021 financial results and business update conference call.

The financial press release for the second quarter was issued a short while ago and can be viewed along with the accompanying slides for this presentation in the news and events section of our Investor Relations page on our website Www Dot Rigel Dot 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.

These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted.

A description of these risks can be found in our most recent annual report on form 10-K for the year ended December 31, 2020, and subsequent filings with the SEC, including our Q2 quarterly report on form 10-Q on file with the SEC.

Dolly Vance: A description of these risks can be found in our most recent annual report on Form 10-K for the year ended December 31, 2020, and subsequent filings with the SEC, including our Q2 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 would like to turn the call over to our CEO, Raul Rodriguez.

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

At this time I would like to turn the call over to our CEO Raul Rodriguez.

Thank you Dolly and thank you everyone for joining us on our second quarter 2021conference call on.

Dolly Vance: Thank you, Dolly, and thank you, everyone, for joining us at our second quarter 2021 conference. Also joining me today are Wolfgang Dummer, our Chief Medical Officer; Dave Santos, our Chief Commercial Officer; and Dean Schorno, our CFO.

Also joining me today are Wolfgang Dummer, our Chief Medical Officer.

Santos, our chief commercial officer.

And Dean <unk> our CFO.

Now beginning on slide 5.

Raul R. Rodriguez: Now beginning on slide five, during the second quarter, Rigel continued to make good progress across all of our key value drivers, as you see on this page. While some of the headwinds of the COVID pandemic have begun to subside, the opportunities to address the pandemic remain very real and very near term. We'll discuss this during our call. In ITP, we had very good growth relative to last year, as well as a substantial improvement over Q1, with a 38% increase in net sales. Dave and Dean will describe our net sales trend in more detail.

During the second quarter Rigel continued to make good progress across all of our key value drivers as you see on this page.

While some other headwinds of the pandemic began to subside the opportunity to address the pandemic remain very real and very near term.

We'll discuss this during our call.

In I T. P. We had very good growth relative to last year as well as a substantial improvement over Q1 with a 38% increase in net sales day.

David Dean will described our net sales trends in more detail.

Dave will also describe how we're increasing the size of our sales force to better address our he met him on customers and I T P and to prepare for the potential opportunity in warm autoimmune hemolytic anemia or AI a trip.

Raul R. Rodriguez: They will also describe how we're increasing the size of our sales force to better address our heme and heme on customers in ITP and to prepare for the potential opportunity in warm autoimmune hemolytic anemia or AIHA. We have made important progress in warm AIHA. We have now enrolled 80 of our targeted 90 patients in this trial, and we have added eight patients in the last three months. This enrollment progress puts us closer to our goal to be the first approved product for the treatment of warm AIHA, with the potential to capture a substantial share of this significant market opportunity.

We made important progress in warm AIA chip, we have now enrolled 80 of our targeted 90 patients in this trial, we added 8 patients in the last 3 months.

This enrollment progress puts us closer to our goal to be the first approved product for the treatment of warm AIA he with the potential to capture a substantial share of this significant market opportunity.

We have also made excellent progress in our Covid program with Foster Madness, which has the potential to provide a still much needed therapy for hospitalized COVID-19 patients.

Raul R. Rodriguez: We have also made excellent progress in our COVID program with Foster Med, which has the potential to provide a still much-needed therapy for hospitalized COVID patients. In Q2, we reported positive top-line results from our Phase 2 clinical trial, conducted in collaboration with NIH and Inova. Wolfgang will provide a brief overview of these exciting and potentially impactful results with an update on our other COVID clinical trials. In late May, we filed the EUA with the U.S. FDA and are awaiting their decision.

In Q2, we reported positive top line results from our phase II clinical trial conducted in collaboration with NIH and they know about.

Wolfgang will provide a brief overview of these exciting and potentially impactful results with an update on our other corporate for clinical trials.

In late May we filed the EUA with the U S. F D. A and are awaiting their decision R..1 phase III trial in hospitalized COVID-19 patients has enrolled very quickly reaching over 150 patients nearly half the targeted 308 patients and with a 90 pay.

Raul R. Rodriguez: Our own phase 3 trial in hospitalized COVID patients has enrolled very quickly, reaching over 150 patients, nearly half the targeted 318, and with 90 patients enrolling in just the last two months. We are delighted to be included in the NIH-sponsored ACTIV4 host tissue study in hospitalized patients with COVID-19 and see that the first patient has already enrolled. In our earlier programs, with our IRAP 1-4 program, we received FDA feedback on our low-risk MDS study and have incorporated it into our Phase 1-2 study protocol. We look forward to starting this with our R289, which is a prodrug of our RA35 molecule.

Enrolling in just the last 2 months.

We are delighted to be included in the NIH sponsored active for host tissue study in hospitalized patients with COVID-19, and see that the first patient has already enrolled.

On the earlier programs with our Iraq..1 for program. We have received FDA feedback on our low risk Mds study and have incorporated that into our phase 1.2 study protocol we.

We look forward to starting this with R. R 289, which is a prodrug of R. R. <unk> hundred 5 molecule.

With a rip 1 inhibitor program, we have 2 efforts moving forward with our partner Lilly.

Raul R. Rodriguez: With our RIP1 inhibitor program, we have two efforts moving forward with our partner Lilly. We are working on entering a phase two clinical study with R552, a systemic molecule. And we're also advancing our CNS penetrant molecule, which is in preclinical studies and has potential in indications such as Alzheimer's and ALS. In all, we had a very good quarter across all of our key value documents.

We are working on entering a phase II clinical study with our 505 to a systemic molecule.

And we're also advancing our CNS penetrant molecule, which is in preclinical studies and has potential in indications such as Alzheimer's and ALS.

You know we had a very good quarter across all of our key value drivers.

Raul R. Rodriguez: While we're still navigating through some of the COVID headwinds in some areas, we hope these will subside during the second half of the year. The opportunity to address what is a substantial need in COVID remains, and we are committed to the patients who are suffering and the clinicians who are treating them as well. Today, we'll start with Dave's discussion of our commercial progress and expansion, followed by Wolfgang's update on our clinical programs, and then Dean's financial update. Dave, to you.

Still navigating through some of the Covid headwinds in some areas. We hope we can these will subside during the second half of the year GAAP.

The opportunity to address what is a substantial need in COVID-19 remains and we are committed to the patients who are suffering and the clinicians who are treating them as well.

Today, we'll start with Dave's discussion on our commercial progress and expansion then followed by Wolfcamp update on our clinical programs and then deans financial up.

Dave for you.

Thank you Raul and good afternoon.

David A. Santos: Thank you, Raul, and good afternoon. I'm happy to say that I'm on the line from the road today as I attend our summer sales meeting. It has been terrific to be able to spend time in person with the highly talented members of our commercial team... And I can report they're all quite enthused about being together with one another and their customers. That will be the theme of my presentation this afternoon as our return to the field continues, and we're able to make an even greater impact on our customers and their... Before I begin, I would like to thank the entire commercial team for their commitment and hard work throughout the quarter to continue expanding our impact with Tavala.

I'm happy to say that I'm on the line from the relative today as I attend our summer sales meeting.

It has been terrific to be able to spend time in person with a highly talented members of our commercial team and I can report, they're all quite enthused about being together with 1 another and their customers GAAP.

That will be a theme of my presentation. This afternoon is our return to field continues and we're able to make an even greater impact on our customers and their patients.

Before I begin I would like to thank the entire commercial team for their commitment and hard work throughout the quarter to continue expanding our impact for <unk>.

David A. Santos: I am very proud of our return to growth in Q2. I would now like to move on to slide 7, where you will see that our FDA-approved indication is for adult patients with chronic immune thrombocytopenia, or CIT, who've had an insufficient response. Moving to slide 8, we produced Q2 net product sales of $17.1 million.

Im very proud of our return to growth in Q2.

I would now like to move on to slide 7.

Where you will see that our FDA approved indication.

As for adult patients with chronic immune thrombocytopenia R. C. ITT, who have had an insufficient response to a previous treatment.

Moving to slide 8.

We produced Q2 net product sales of $17.1 million.

David A. Santos: A 14% increase over the same quarter last year, we also achieved our highest quarterly volume to date of 1,905 bottles. While some of that bottle volume was a return to normal inventory levels in our distributors during, we were very happy. Positive Trends in Bottle Shift to Patients and Clinics as a Quarter Progresses The graph on the left depicts our quarterly bottles shipped to patients and clinics since 2019. So you can compare our 2021 demand volume to last year and 2020.

14% increase over the same quarter last year.

We also achieved our highest quarterly volume to date of 1900.5 bottles.

Some of that bottle volume was a return to normal inventory levels in our distributors during Q2.

We were very happy to see positive trends in bottles shipped to patients and clinics as a quarter progressed.

The graph on the left depicts our quarterly bottles shipped to patients and clinics since 2019.

So you can compare our 2021 demand volume to last year and 2019.

David A. Santos: You will see that our demand from patients and clinics has grown in every quarter versus the prior year. In Q2, we delivered 6% sequential growth over Q1 and 12% year-over-year growth compared to Q2 of 2020. We are very encouraged by this upward momentum and demand and believe it will continue to grow as clinics reopen and we can increase our in-person engagements with customers. Why we believe that is depicted in slide nine. On the left side, you will see the progression of our Salesforce interaction through the first two quarters of this year. The blue bars represent the virtual interaction, and the orange bars are the in-person interactions.

You will see that our demand for patients and clinics has grown in every quarter versus the prior year.

In Q2, we delivered 6% sequential growth over Q1, and 12% year over year growth compared to Q2 of 2020.

We are very encouraged by this upward momentum in demand and believe it will continue to grow as clinics reopen and we can increase our in person engagements with customers.

And why we believe that is depicted in slide 9.

On the left side, you'll see the progression of our sales force interactions through the first 2 quarters of this year.

The blue bars represent the virtual interactions and the orange bars are in person interactions.

David A. Santos: We've grown overall interactions significantly throughout, and the biggest driver for this is the increase in in-person interactions, where we nearly tripled the number compared to Q1. In fact, as you can see from the dark blue line, our percentage of in-person calls has grown significantly. And in Q2, it was great that half of our interactions were in person.

We have grown overall interactions significantly throughout this year.

And the biggest driver for this is the increase in in person interactions in Q2, where we nearly tripled the number compared to Q1.

In fact as you can see from the dark Blue line, our percentage of in person calls has grown significantly since Q1 and in Q2. It was great to see that half of our interactions were in person.

Importantly, we have significantly accelerated our in person interactions without seeing any significant reduction in virtual interactions.

David A. Santos: We have significantly accelerated our in-person interactions without seeing any significant reduction in virtual meetings. Our team is doing a great job leveraging every opportunity available to make in-person sales calls, hold live speaker programs, and attend live conferences, where they can see their customers. All of these interactions are contributing to broader reach among clinicians and the resulting stronger demand for Katava, building on this trend and as shown on slide 10. We made the strategic decision in Q2 to expand the size of our commercial activities, to extend our reach to more customers and accelerate awareness among prescribers, particularly as we have more opportunities to see them in person.

Our team is doing a great job leveraging every opportunity available to meet in person sales calls hold live speaker programs and attend live conferences, where they can see their customers.

All of these interactions are contributing to broader reach among clinicians and the resulting stronger demand for <unk>.

To build on this trend and as shown on slide 10, we made the strategic decision in Q2 to expand the size of our commercial organization to extend our reach to more customers and accelerate awareness among prescribers, particularly as we have more opportunity.

To see them in person.

We are expanding 40% from 39 to 55 territories.

David A. Santos: We are expanding 40% from 39 to 55 territories, giving us the capacity to call on the majority of prescribers who treat and reducing travel time for our customers, allowing them to call on their customers more frequently through market research. The Efficacy Messages We Have Developed With Tavit, But with our previous sales force size, as well as the constraints caused by the pandemic, we were not able to reach as many clinicians as we had hoped. We believe that our sales force expansion will significantly improve. Get Top of Mind for Clinicians, see a patient; they're ready to start or switch therapies for IBS.

Giving us the capacity to call on the majority of prescribers, who treat ITT and reduced travel time for our team, allowing them to call out on their customers more frequently.

Through market research, we continue to see physicians respond positively to the efficacy messages, we have developed with copper-leaf, but with our previous sales force size as well as the constraints caused by the pandemic, we were not able to reach as many clinicians as we had hoped to.

We believe that our sales force expansion will significantly improve the awareness and get probably top of mind for clinicians when they see a patient they are ready to start for switch therapies for IPP.

You will see on the bottom of the slide that we've already made strong progress in recruiting and hiring our new team members and we expect that all territories will be operational by the end of next month.

David A. Santos: You will see on the bottom of the slide that we've already made strong progress in recruiting, And we expect that all territories will be operational by the end of the year. And lastly, on slide 11, I wanted to highlight the outstanding needs, For more information, visit www.fema.gov, particularly in earlier lives.

And lastly on slide 11, I wanted to highlight the outstanding tools, we have for our sales force to spread our efficacy message, particularly in earlier lines.

First on the left and as you may recall, we have been actively promoting our post hoc analysis highlighting high response rates in earlier lines.

David A. Santos: First, on the left, and as you may recall, we have been actively promoting our post-hoc analysis, highlighting high response rates in earlier lives. We expect that as our teams make more calls in person, the awareness and memorability of this data will continue. Secondly, an important point, we will be implementing well-researched and effective messaging based on our five-year data showing meaningful platelet..., that are highly durable over time. In fact, 70% of patients sustained clinical benefit over time to platelet counts of 30,000 or higher, and this was seen in some patients beyond four years.

We expect that R. As our teams make more calls in person the awareness and memorabilia of this data will continue to increase.

Secondly, and importantly, we will be implementing well researched and effective messaging based on our 5 year data showing meaningful platelet increases that are highly durable over time.

In fact, 70% of patients sustained clinical benefit over time to platelet counts of 30000 or higher and this was seen for some patients beyond for years.

We believe this will augment our existing efficacy messages nicely in.

David A. Santos: We believe this will augment our existing efficacy messages, and we look forward to seeing more and more clinicians respond with new patients on top. In summary, we are seeing demand for Tavalees increase as we see more customers with our compelling effort by implementing our expansion with talented and experienced sales team members and equipping them with even more powerful messaging on the efficacy of tavelin. We are well-poised to accelerate growth as we move into the fall and final. Thanks for your attention, and I will now turn the call over to Wolfgang. Thank you, Dave.

And look forward to seeing more and more clinicians respond with new patients on top of a lease.

In summary, we are seeing demand for <unk> increase as we see more customers with our compelling efficacy messages.

By implementing our expansion with talented and experienced sales team members and equipping them with even more powerful messaging on the efficacy of total lease we are well poised to accelerate growth as we move into the fall and final quarter of the year.

Thanks for your attention and I will now turn the call over to Wolfgang Wolfgang.

Yeah.

Thank you Dave.

Let me start with warm autoimmune hemolytic anemia.

Wolfgang Dummer: Let me start with warm autoimmune hemolytic anemia. Slide 13 gives you a brief update on our ongoing Phase 3 study. Despite some continued disruptions due to COVID-19, we continue to steadily randomize patients into the trial. As Raul mentioned, as of today, we have 80 patients randomized out of our target of approximately 90. Fifty-three of those patients have already reached 24 weeks, and the vast majority of those have rolled over into the extension study as well.

Slide 13 gives you a brief update on our ongoing phase III study despite.

Despite some continued disruption due to COVID-19, we continue to stay steady randomized patients into the trial.

As Rob mentioned us up today, we have 80 patients randomized over our target of approximately 90.

53 of those patients have already reached 24 weeks and the vast majority of those have rolled over into the extension study as well.

As we are in the final stages of enrollment we all looking forward to the upcoming people total 24 week data readout.

Wolfgang Dummer: As we are in the final stages of enrollment, we are looking forward to the upcoming pivotal 24-week data readout. With no therapies near FDA approval, a significant unmet medical need remains, and the opportunity is large. Dr. Matnip is in the advanced stages of Phase 3 development and would be the first to market in this indication. And as a reminder, Dr. Matnip has FDA FosTrack as well as Orphan Drug designation. Let's now switch gears to our COVID program for Foster Martin. Slide 15.

With no therapies, new FDA approval on a significant unmet medical need remains and the opportunity is large.

Using the advanced stages of phase III development and would be the first to market in this indication and as a reminder, close to math depends if the pulse trick Israelis orphan drug designation.

Let's now switch gears to our Covid program for force them out.

Slide 15.

Wolfgang Dummer: A little over a year ago, we began to explore the potential of fostamatinib as a treatment for COVID-19. It started with external research from the University of Amsterdam, as well as MIT and Harvard, which provided compelling experimental evidence that fostamatinib might be beneficial in COVID-19 disease. That has raised a strong interest by external clinical institutions, such as the NIH, NHLBI, and the Imperial College of London, to take Fostermatinib into COVID-19 patients.

A little over a year ago, we began to explore the potential of post imatinib as a treatment for COVID-19.

It started with external research from the University of Amsterdam, as well as M. I T in hulbert, which provided compelling experimental evidence that both of them up on it but it might be beneficial if COVID-19 disease.

They've had 3 strong interest by external clinically juice us such as the NIH and H N V. I N. The Imperial College of London to take force them into COVID-19 patients.

We shouldn't get shared with US a positive outcome from the NIH sponsored phase 2 in April based on the data we have filed for an emergency use authorization made me, which is currently under review.

Wolfgang Dummer: We've shared with you the positive outcome from the NIH-sponsored Phase 2 in April. Based on that data, we filed for an emergency use authorization in late May, which is currently under review. We also have a Rigel-sponsored Phase III study ongoing, which is progressing well. An update on that later.

Also have a rigel sponsored phase III study ongoing which is progressing well on update on debt later and on top of debt. The NIH has chosen post them up as 1 arm in a large randomized phase III trial called equity for to provide additional data on post them on and severe hospitalized patients.

Wolfgang Dummer: And on top of that, the NIH has chosen fostamatinib as one arm in a large, randomized Phase III trial called ACTIV-4 to provide additional data on fostamatinib in severe hospitalized patients. As we can all see, with new virus variants evolving and vaccination rates plateauing, there remains a clear need for options to treat COVID-19 disease and improve outcomes in hospitalization. Slide 16, shows you the various patient population covered by our clinical program.

As we can all see with the new virus variants evolving and vaccination rates plateauing, there remains a clear need for options to treat COVID-19 disease and improve outcomes for hospitalized patients.

Slide 16.

Shows you the various patient population covered with our clinical program.

Wolfgang Dummer: The recent data from the NIH included patients with a 5, 6, or 7 rating on the widely used 8-point ordinal scale, which are the most severe patients. That is of special interest because these patients are presumably the hardest to treat.

The recent data from the NIH included patients with a 5.6 or so I've been reading on the widely used 8 point ordinal scale, which are the most severe patients.

That is especially interest because these patients on presumably the hardest to treat.

The newly initiated exit for whose tissue phase III study cabos, a similar patient population.

Wolfgang Dummer: The newly initiated ACTIV-4 host tissue phase 3 study covers a similar patient population. The Imperial College London study in our Phase 3 clinical trial will include milder patients with scores in the 3, 4, and 5 range and will investigate if fostamatinib can prevent progression of mild patients to severe disease. So these clinical trials are evaluating post-traumatic outcomes in a wide range of COVID-19 patient populations. Let me remind you of the key takeaways from the recently completed Phase 2 NIH study on slide 17. The study enrolled 59 patients, randomized one-to-one to post-traumatic plus standard of care versus placebo plus standard of care.

The Imperial College of London study in our Phase III clinical trial will include milder patients with schools and the 3.4 and pay for each and will investigate it forced them up and it can prevent the progression of my other patients with severe disease.

So these clinical trials or are you about evaluating post them up given the wide range of COVID-19 patient populations.

Let me remind you of the key takeaways from the recently completed phase 2 in each study on slide 17.

The study enrolled 259 patients randomized 1 to 1 to post Imatinib plus standard of care versus placebo plus standard of care.

Wolfgang Dummer: The primary endpoint was safety, as measured by the incidence of serious adverse events. To fully appreciate the primary outcome, you need to remember that the first question in the study was, is it safe to add fostamatinib on top of standard of care, such as dexamethasone and remdesivir? Given Foster Matanib's favorable safety profile, the hypothesis was that the rate of serious AEs in both groups would be about the same or similar, and that would have met the safety goals already.

The primary endpoint was safety as measured by the incidence of serious adverse events.

To fully appreciate the primary outcome you need to remember that the first Christian. This study was is it safe to air force them up on top of standard of care such as submit the zone, England designate.

Moving post them up nibs favorable safety profile. The hypothesis was that the rate of serious ease in both groups would be about the same or similar and which would have met the safety goes already.

Wolfgang Dummer: However, the incidence of SAEs turned out to be cut in half in the Foster Matanib group compared to standard of care alone. Given that several of the SAEs in the standard of care group were COVID-relevant hypoxemia events, this improved safety outcome is already a good surrogate for efficacy. There were three deaths in this trial, and all three occurred in the standard of care alone group. There were no deaths in the post-

The incidents of east turned out to be cut in half in the post them up on the group compared to standard of care alone.

Given that several of us so using the standard of care group for Covid.

<unk> really been type of excuse me the bins.

Improved safety outcome is already a good surrogate for efficacy.

There were 3 deaths in the trial all 3 occurred in the standard of care alone group. They were no debt in the post them ethnic group.

Wolfgang Dummer: It is also worth noting that there were four patients, two in each arm, who entered the study intubated and on mechanical ventilation. The two patients in the placebo group both died, while the two patients on ventilation in the fostamatinib group could be extubated and survived. That is quite remarkable given the high likelihood of death once a patient needs to be intubated and mechanically ventilated.

It is also worth noting that there were for patients to each arm, who entered the study intubated and on mechanical ventilation.

The 2 patients in the placebo group both deceased while the 2 patients on being police on the post Imatinib group could be debated and survived.

That is quite remarkable given the high likelihood of debt once a patient needs to be integrated and mechanically ventilated.

There were multiple other.

Secondary efficacy endpoints in the study and I can tell you that they are all consistently favoring post imatinib such as improvement in ordering the scale. These on oxygen as well as number of days in the intensive care unit.

Wolfgang Dummer: There were multiple other secondary efficacy endpoints in the study, and I can tell you that they are all consistently favoring fostamatinib, such as improvement on the ordinal scale, days on oxygen, as well as number of days in the intensive care unit. And finally, the clinical findings were also consistent with improvement in objective lab measures, such as mitosis, seroactive protein, ferritin, or D-dimer. We see quite beautiful improvements in these biomarkers, which are well accepted as relevant to indicate inflammation and blood clotting in COVID-19 patients. And as I said, all these effects are in addition to remdesivir and dexamethasone, which is remarkable. On slide 18.

And finally, the clinical findings were also consistent with improvement in objective measures such as mitosis C reactive protein farrington with D dimer.

We see quite beautiful improvements in these biomarkers, which are well accepted as relevant to indicate inflammation and blood clothing in COVID-19 patients.

As I said all these effects or in addition to her and desert view into the commits us film which is remarkable.

On slide 18.

You see.

More detail on our right to late Phase III study.

Studying include hospitalized.

Patients with mild disease, who have certain risk factors to develop more severe disease.

If positive this trial could be the basis for potential label expansion for post imatinib to treat patients with COVID-19.

The study is conducted at approximately 30 sites in the U S and South America, where Covid continues to be a big issue.

The study is enrolling rapidly and as of now we have over 150 patients enrolled.

We currently expect to complete enrollment before the end of the year.

Wolfgang Dummer: You see more detail on our right-to-lead phase three. The study includes hospitalized patients with mild disease who have certain risk factors to develop more severe diseases. If positive, this trial could be the basis for potential label extensions for fosfamatinib to treat patients with COVID-19. The study is conducted at approximately 30 sites in the U.S. and South America, where COVID continues to be a big issue. The study is enrolling rapidly, and as of now, we have over 150 patients enrolled. We currently expect to complete enrollment before the end of the year.

On Slide 19, you can see on the overview of the NIH.

In H E for trial as we announced in late June post Imatinib.

For this study.

The trial is evaluating for different treatments, including first time I've met in hospitalized patients with COVID-19. The patient population is similar to the NIH phase II study that I showed you earlier and will enroll approximately 300 patients each for them.

The Master protocol is designed to be flexible to allow for stoping and adding of new therapies based on pre planned futility analysis in each arm.

The trial will be run it's more than 50 sites and is currently recruiting patients first patients treated was announced by the NIH on July 22nd.

So in summary on slide 20, we.

Wolfgang Dummer: On slide 19, you can see an overview of the NIH ACTIV-4 trial. As we announced in late June, Fostermatinib was selected for this study. The trial is evaluating four different treatments, including fostamatinib, in hospitalized patients with COVID-19.

We have completed an H phase III study with a day that having been submitted to a peer reviewed journal Rachel.

Rachel submitted an EUA in late May and we are awaiting a decision from FDA.

Oh, a phase III study continues to enroll patients and has already over 150 patients enrolled to date.

NIH active for whose tissue study has started and us recruiting patients.

And the Imperial College of London, Mendes investigator sponsored Phase II study is ongoing and his enrolled about 125 patients so for.

Wolfgang Dummer: The patient population is similar to the NIH Phase 2 study that I showed you earlier and will enroll approximately 300 patients in each form. The master protocol is designed to be flexible to allow for stopping and adding new therapies based on pre-planned utility analysis in each arm. The trial will be run at more than 50 sites and is currently recruiting patients. The first patient treated was announced by the NIH on July 22nd.

These studies will generate a lot more day, either which will be incredibly vulnerable for exploring post imatinib in influenza or other non COVID-19 related acute respiratory distress syndrome.

Yeah.

So now, let's turn to our pipeline programs area come on for it in group 1.

Slide 22.

The IraQ1 in for pathways, all promising targets in inflammation, driven all the immune diseases as well as certain team on conditions like low risk Mds.

Wolfgang Dummer: So, in summary, on slide 20... We have the completed NIH Phase 2 study, with the data having been submitted to a peer-reviewed journal. Rigel submitted an EUA in late May, and we are awaiting a decision from FDA. Our Phase III study continues to enroll patients and has already enrolled over 150 patients to date. The NIH ACTIV-4 host tissue study has started and is recruiting patients, and the Imperial College of London MADIS investigator-sponsored Phase II study is ongoing and has enrolled about 125 patients so far.

R E..3 5 is a dual inhibitor of both IraQ1 in for.

Rich in preclinical study showed more complete suppression of information compared to selective inhibitor with Iraq for on me.

As discussed previously we believe Iraq, 1 for pathways or ideal targets for treatment of low risk Mds interest cost information on the bone marrow that leaves kaboom route efficiency inside opinion.

Slide 23.

With our 835, we have generated initial proof of concept data with them Lps challenge in healthy human volunteers.

Profound inhibition of Lps induced inflammatory cytokine production such as IL 6 TNF Alpha IL 8.

Wolfgang Dummer: These studies will generate a lot more data, which will be incredibly valuable for exploring the benefits of somatinib in influenza or other non-COVID related acute respiratory distress syndrome. So now, let's turn to our pipeline programs, IREC 1.4 and RIP 1. Slide 22.

Moreover, a R E..3 5 was well tolerated in the single ascending dose and multiple ascending dose study.

For the linear PK profile.

Proportional exposure.

Slide 24.

In order to improve oral bioavailability and clinically exposure levels, we utilized our previous expertise with total knees and created a prodrug or a 3.5 cold or 2 weird mine.

Wolfgang Dummer: The IREC-1 and IV pathways are promising targets in inflammation-driven autoimmune diseases, as well as certain heme-onc conditions like low-risk MDS. R835 is a dual inhibitor of both IRAC1 and 4, which in preclinical studies showed more complete suppression of inflammation compared to a selective inhibitor of IRAG4 only. As discussed previously, we believe the IRAC1-4 pathways are ideal targets for treatment of low-risk MDS, which is caused by inflammation in the bone marrow that leads to bone marrow deficiency and cytopenia.

We have now completed.

Ascending dose and multiple ascending dose phase 1 studies with the new molecule.

As expected our 289 was well tolerated in healthy volunteers and the PK PD target plasma drug exposure levels and safety results were comparable to our phase 1 results with R. E..3 5.

We presented the data to the FDA in a pre IND package and received good feedback on our proposed phase 1 study design for low risk Mds.

So what's next.

Incorporating the FDA feedback into our clinical development program and plan to move into the clinic with this phase 1.2 study in low risk Mds.

Wolfgang Dummer: Slide 23. With R835 we have generated initial proof of concept data with an LPS challenge in healthy human volunteers. There was profound inhibition of LPS-induced inflammatory cytokine production, such as IL-6, TNF-alpha, or IL-8. Moreover, R835 was well tolerated in the single ascending dose and multiple ascending dose study and had a linear PK profile and post-proportional exposure.

Additionally, we are continuing to explore indications in the Ria on immune disease, such as Palmoplantar post to most of us hidradenitis Suppurativa and others. So.

So we are very excited about our progress with the Iraq.

Slide 25.

We also wanted to update you on our new research collaboration with MD Anderson Cancer Research Institute with the goal to evaluate or 2 at 9 and R. E..3 5 in cell cultures, and animal models of Indias and chronic my other moments citic leukemia.

This translational research will add further to the body of data generated to date for Iraq program.

They're very excited to be working with Dr. Dere move go see them on the Arris team at M. D. Anderson.

Wolfgang Dummer: In order to improve oral bioavailability and clinical exposure levels, we utilized our previous expertise with Tavalis and created a prodrug of R835 called R289. We have now completed single ascending dose and multiple ascending dose phase one studies with the new molecule. As expected, R289 was well-tolerated in healthy volunteers, and the PK, PD, target plasma drug exposure levels, and safety results were comparable to our Phase I results with R835. We presented the data to the FDA in a pre-IND package and received good feedback on our proposed Phase I study design for low-risk MDAs. So what's next?

And there are is.

If they are recognized leaders in human hematologic cancer research and we look forward to exploring opportunities for clinical collaborations Israel.

I will conclude with slide 26.

Another very important value driver for Rigel is our reported and he'd be the program that we have partnered with Lilly.

The first candidates arc 552 is an oral systemic inflammatory.

Inflammatory conditions.

We're working closely with Lilly on planning for the first phase III study on all the new indications.

In addition, his rigel, we or working on selecting 1 inhibitor candidate that can cross the blood brain barrier.

Lilly will lead.

Lead the clinical development of the brain penetrating reported an EBIT does in CNS diseases.

We're very excited about the broad potential for reported and he'd be loose in numerous soldier indications and Lilly is the ideal partner to have with the huge expertise in developing therapies for autoimmune and CNS diseases.

Wolfgang Dummer: We are incorporating the FDA feedback into our clinical development program and plan to move into the clinic with the Phase I and II studies in low-risk MDAs. Additionally, we are continuing to explore indications in rare autoimmune diseases, such as palmoplantar pustulosis, hidradenitis superativa, and others. So we are very excited about our progress with IRAC. Slide 25.

With that for a like to turn to Dean for finance update.

Okay.

Thank you Wolfgang I'm on slide 28 for the second quarter of 2021, we shipped 1905 bottles to our specialty distributors, resulting in $22.1 million of gross product sales 1693 of those bottles were shipped to patients and clinics while 90.

<unk> hundred 61 bottles remained in our distribution channels at the end of the quarter.

Wolfgang Dummer: We also wanted to update you on a new research collaboration with the MD Anderson Cancer Research Institute with the goal to evaluate R289 and R835 in cell cultures and animal models of MDS in chronic myelomonocytic leukemia. This translational research will add further to the body of data generated to date for our IRAC program. We're very excited to be working with Dr. Guillermo Garcia-Manero's team at MD Anderson, and they are recognized leaders in hematologic cancer research.

We reported net product sales from Pablo <unk> of $17.1 million, a 14% increase compared to the second quarter of 2020.

Our net product sales from Tabriz for recorded net of estimated discounts charge backs rebates returns co pay assistance and other allowances of $5 million on.

Gross to net adjustment was approximately 22.6% of gross product sales.

Before we move on for net product sales, let me review our expectations for the third quarter of 2021.

Wolfgang Dummer: And we look forward to exploring opportunities for clinical collaborations as well. I'll conclude with slide 26. Another very important value driver for Rigel is our RIP-1 inhibitor program that we have partnered with Lilly. The first candidate, R552, is an oral systemic RIP-1 inhibitor, an inflammatory group.

Expect to see continued growth in the third quarter and bottle shipped for patients and clinics similar to what we saw on the second quarter.

Once our sales force expansion is completed towards the end of the third quarter and assuming that access to physicians and patients continues to expand we expect to see an acceleration of sales on the fourth quarter.

Incrementally we currently expect our gross to net adjustment to be approximately 23% for 24% in the third quarter of 2021.

Wolfgang Dummer: We're working closely with Lilly on planning for the first phase two study in an autoimmune indication. In addition, here at Rigel, we are working on selecting a RIP1 inhibitor candidate that can cross the blood-brain barrier. Lilly will then lead the clinical development of brain-penetrating RIPon inhibitors in CNS disease.

Moving on to the next slide in addition to net product sales Rigel contract revenues from collaborations were $3.7 million for the 3 months ended June 30th 2021, which consisted of revenues recognized from our deferred revenues of $3.3 million from our license agreement with Lilly.

Dean L. Schorno: We're very excited about the broad potential for RIP-1 inhibitors in numerous large indications, and Lilly is the ideal partner to have with their huge expertise in developing therapies for all immune and CNS diseases. With that, I'd like to turn to Dean for a finance update. Thank you, Wolfgang. I'm on slide 28.

$400000 related to the performance of certain research and development services pursuant to our collaboration with grip holds.

Government contract revenues of $5.5 million was related to income we recognized pursuant to our agreement with the U S Department of defense for our ongoing phase III clinical trial of fast Imatinib and COVID-19.

Dean L. Schorno: For the second quarter of 2021, we shipped 1,905 bottles to our specialty distributors, resulting in $22.1 million in gross product sales. 1,693 of those bottles were shipped to patients and clinics, while 961 bottles remained in our distribution channels at the end of the quarter. We reported net product sales and top release of $17.1 million, a 14% increase compared to the second quarter of 2020. Our net product sales and tabloids were recorded net of estimated discounts, chargebacks, rebates, returns, copay assistance, and other allowances of $5 million. Our gross to net adjustment was approximately 22.6% of gross product sales.

Moving on to costs and expenses our cost of product sales was approximately $129000 for the second quarter of 2021.

Total costs and expenses were $39.3 million in the second quarter of 2021 versus $33.4 million in the second quarter of 2020.

The net increase in cost was primarily due to increases in personnel related costs stock based compensation expense and research and development costs related to our various ongoing clinical studies.

Given our sales force expansion and certain preparations for potential E way, we expect total costs and expenses for the remainder of the year to increase.

As we gain clarity on the timing of a potential EUA approval will provide appropriate updates.

Finally, we ended the quarter with cash cash equivalents and short term investments of $153.4 million.

With that I'd like to turn the call back over to ROE Roe.

Dean L. Schorno: Before we move on from net product sales, let me review our expectations for the third quarter of 2021. We expect to see continued growth in the third quarter in bottles shipped to patients and clinics, similar to what we saw in the second quarter. Once our Salesforce expansion is completed towards the end of the third quarter, and assuming that access to physicians and patients continues to expand, we expect to see an acceleration of sales in the fourth quarter.

Thank you Dean.

I am very proud of the progress in the last quarter and we have some exciting milestones that we're working towards in the second half of the year.

T P. We look forward to accelerating our in person interaction with our expanded sales team and reaching more prescribers as the clinics opened for patients.

He's interactions provide the opportunity to educate on earlier line use and as Dave pointed out on the durability of our products keeping top elites top of mind as clinicians help patients make decisions about starting new therapies.

I think we expect to complete enrollment in our phase III clinical trial later this year, we are getting close.

Dean L. Schorno: Incrementally, we currently expect our growth to net adjustment to be approximately 23% or 24% in the third quarter of 2021. Moving on to the next slide, in addition to net product sales, Rigel's contract revenues from collaborations were $3.7 million for the three-month end of June 30, 2021, which consisted of revenues recognized from our deferred revenues of $3.3 million from our license agreement with Lilly and $400,000 related to the performance of certain research and development services pursuant to our collaboration with Griffin. Government contract revenues of $5.5 million were related to income we recognized pursuant to our Moving on to costs and expenses, our cost of product sales was approximately $129,000 for the second quarter of 2021.

<unk> has the potential to meaningfully improve care in this rare disease and to provide a new therapy for patients suffering from warm AIA true currently there are no approved therapies for this indication.

Moving gradually be opportunity to be first to market and a leader in the space.

And COVID-19 cost met them has the potential to address some of the most damaging complications of this disease. We look forward to a decision on our EUA application and completing enrollment of our phase III clinical trials, which as we mentioned is enrolling rapidly. We are very encouraged by our results to date and are working diligently.

It brings us therapy to patients.

In addition to our programs with total lease or post Imatinib. We are excited about the potential of our earlier stage programs Iraq went for and reported.

We look forward to supporting Lilly and the development of our Rip 1 program as we advance our 552 into phase II trials, and we select the brain penetrating candidate for our CNS indications.

Our own our wholly on Iraq for molecule R..289 has tremendous potential and he Marc and auto immune diseases and we are currently planning on the first of these trials in low risk Mds.

Dean L. Schorno: Total costs and expenses were $39.3 million in the second quarter of 2021 versus $33.4 million in the second quarter of 2020. The net increase in costs was primarily due to increases in personnel-related costs, stock-based compensation expense, and research and development costs related to our various ongoing clinical studies. Given our Salesforce expansion and certain preparations for potential EUA, we expect total costs and expenses for the remainder of the year to increase. As we gain clarity on the timing of a potential EUA approval, we'll provide appropriate updates. Finally, we ended the quarter with cash, cash equivalents, and short-term investments of $153.4 million.

We have numerous exciting milestones to look forward to including some in the very near future.

With that let's open up the call to your questions.

Thank you at this time, we'll be conducting a question and answer session if.

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1 moment, please while we poll for questions.

Our first question today is from Yigal <unk> of Citigroup. Please proceed with your question.

Alright, great. Thank you very much for taking the questions and hi, Raul and team I'm.

Raul R. Rodriguez: With that, I'd like to turn the call back over to Raul. Thank you, Dean. I am very proud of the progress in the last quarter, and we have some exciting milestones that we're working towards in the second half of the year. In ITP, we look forward to accelerating our in-person interaction with our expanded sales and reaching more prescribers as the clinic becomes open to patients. These interactions provide the opportunity to educate on earlier line use and, as Dave pointed out, on the important durability of our products, keeping Tavelis top of mind as clinicians help patients make decisions about starting new therapy.

I'm curious what the F. D. A receptivity has been to the EUA discussions based on your favorable phase 2 data in the 60 patient trial as well as the the ongoing phase III, that's enrolling 300 patients because obviously those enrollment figures are several orders of magnitude less than the phase III enrollment for the trials that <unk>.

Part of the E ways for the mrna vaccine so just curious.

How are you thinking about that discrepancy. Thank you.

Yeah, Hello, I'll, let Wolfgang comment on F. D. A reaction on expectations and I'll also add some color commentary after that okay.

Yeah, so interest and Christian.

Raul R. Rodriguez: In AIHA, we expect to complete enrollment in our phase three clinical trial later this year. We are getting close. Fosomatinib has the potential to meaningfully improve care in this rare disease and to provide a new therapy for patients suffering from warm AIHA. Currently, there are no approved therapies for this indication, giving Rigel the opportunity to be first to market and a leader in the space. In COVID-19, tostumatum has the potential to address some of the most damaging complications of this disease.

We have booked very closely with the FDA and you know inquired whether it makes sense to submit a new 8 day day. They did they did come debt. So we did submit the E R.

I can't exactly tell you.

How the FDA is currently thinking because we are not getting constant updates from them. So I can only give you my my personal opinion.

You are correct. Other UAE approved drugs had much larger sample sizes. So all data sets us relatively small with 60 patients, but its double blind placebo controlled and for safety as well as the clinical efficacy data look from a permanent victoza standpoint.

Raul R. Rodriguez: We look forward to a decision on our EUA application and completing enrollment in our Phase 3 clinical trial, which, as we mentioned, is enrolling rapidly. We are very encouraged by our results to date and are working diligently to bring this therapy to patients. In addition to our programs with Tavalisse or Foster Magnum, we are excited about the potential of our earlier stage programs, Irak-1-4 and RIP-1.

Very very strong and very favorably if you if you do your homework and look at some of the some of the endpoints, Inc. And compare the effect sizes with some of the U E approved compounds to post them up on it but it does look very favorable but in essence, you Christian does remain.

Raul R. Rodriguez: We look forward to supporting Lilly in the development of our RIP-1 program as we advance R552 into phase two trials, and we select the brain-penetrating candidate for our CNS indication. Our wholly owned IRAC4 molecule, R289, has tremendous potential in hemalk and autoimmune diseases. And we are currently planning the first of these trials in low-risk MDS. We have numerous exciting milestones to look forward to, including some in the very near future. With that, let's open up the call to your questions. Thank you.

On a review issue at this point.

Okay.

Yeah.

The EUA is intended to be that other emergency use and that are temporary until or your own larger data comes forward and that is coming in the not too distant future. So I think this is appropriate for our U a type of review.

Again, it doesn't mean, we'll get a yes or or certainty, we'll get a dull as yet but it is still being reviewed by the FDA.

Okay. Thanks for Al and then I just had a bit of a housekeeping.

Well.

I have a housekeeping if I could just throw in another question I had a bit of a housekeeping question regarding the phase 2.

Operator: At this time, we'll be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue.

Icl's Slash madis trial.

I just noticed that in your prior slides the eligibility for that trial was points 3 and for on the 8 point ordinal scale, but I got I think they had shifted did it not a debt in today's slides the madis trial shows eligibility spanning points for and 5 on the 8 point ordinates ordinal scale.

Operator: 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 button. One moment, please, while we pull for questions. Our first question today is from Yigal Nochomovitz of Citigroup. Please proceed with your question. Hi, great, thank you very much for taking the questions, and hi Raul and team. I'm curious what the FDA receptivity has been to the EUA discussions based on your favorable phase 2 data in the 60 patient trial, as well as the ongoing phase 3 that's enrolling 200 patients, because obviously those enrollment figures are several orders of magnitude less than the phase 3 enrollment for the trials that supported the EUAs for the mRNA vaccine. So just curious, you know, how you're thinking about that discrepancy.

So.

Correctly was there a change on the enrollment criteria for this 1.

I'll, let Brooks gang answer that but I think it's the <unk>.

Answer is clear go ahead growth yeah. It gets a very sharp observation.

The answer is no there was no change in enrollment criteria that that type of thing, but it's it's a little bit up on auto fixed on this scale because the B pillar College of London uses a slightly different scale.

We used to think it equally on the site, but now it.

It has shifted 1 but simply due to the useful for slightly different scaled that they're using.

I see this as an accurate accurate representation.

Okay got it and then just the last question I had on the the IraQ1 for what is the thinking behind the need to do a prodrug formulation of <unk> 5 vs versus not.

Yigal Dov Nochomovitz: Thank you. I'll let Wolfgang comment on FDA reaction expectations, and I'll also add some color commentary after that.

Wolfgang Dummer: Yeah, interesting question. We have worked very closely with the FDA and inquired whether it made sense to submit an EUA. They did welcome that, so we did submit the EUA. I cannot exactly tell you how the FDA is currently thinking because we're not getting constant updates from them, so I can only give you my personal opinion. A.

Sure Okay.

Yeah, So and he knows me, which we've shown you a low 3.5 which is a great molecule we'd be hit the preclinical experiments done with 835 as well as the phase 1 healthy human volunteers, but it turns out that our 2.8 and 9 which is cleaved and then.

Even though the results in the release of 835 is much better bioavailability and and endless variability in patients. So it's much it's it it's clearly.

Wolfgang Dummer: Other EUA-approved drugs had much larger sample sizes, so our data set is relatively small with 60 patients, but it's double-blind and placebo-controlled, and the safety as well as the clinical efficacy data look, from an effect size standpoint, very, very strong and very favorable. And if you do your homework and look at some of the endpoints and compare the effect sizes with some of the EUA-approved compounds, Foster-Martin does look But, in essence, your question does remain a review issue at this point.

Our beta beta compounds to administer 835 to the patient to get the active metabolite is still 8.5 so the data that we have generated would be they'd prefer for students are still relevant but it's a it's a rocket administer a drug administration advantage for them to 8.9.

Henry we're waiting to hear also from the from the FDA on the 2.8 non Didnt there were and agreement that are giving us the green light to proceed with this low risk Mds study with 2 at night.

Got it thank you Raul and team.

Raul R. Rodriguez: Okay, guys. The EUA is intended to be that, an emergency use, and a temporary measure until your own larger data comes forward. And that is coming in the not-too-distant future.

Thank you.

The next question is from Chris Raymond of Piper Sandler. Please proceed with your question.

Hi, This is no coke, Nebraska on for Chris Congrats on the quarter on thanks for taking our question I guess, maybe 1 on Uncap Elyse. So we're starting to hear more about potential commercial headlines now with the Doctor variant for gang I guess for your catalyst growth expectations throughout the remainder of the year does that take into account any.

Raul R. Rodriguez: So I think this is appropriate for an EUA type of review. Again, doesn't mean we'll get a yes or certainly we'll get a no as yet, but it's still being reviewed by the FDA. Okay, thanks Raul. And then I just had a bit of a house...

Potential COVID-19 impact or is it start too early on that front.

Thank you Nicole I'll ask Dave to comment on that.

Hi, Nicole this is Dave.

Yigal Dov Nochomovitz: I had a bit of a housekeeping question, if I could just throw in another question, I had a bit of a housekeeping question regarding the Phase 2 ICL slash MADIS trial. I just noticed that on your prior slides, the eligibility for that trial was points three and four on the eight-point ordinal scale, but I think it shifted. Did it not?

From our standpoint to Covid.

Covid delta various kind of affecting our ability moving forward.

Yeah.

I think we've been at least a very through.

Through the very rough storm of 2020, when things were locked down and.

It was very difficult to go anywhere.

As you know.

When you compare that to kind of where we are at now where yes, you do have a delta there yet but.

Yigal Dov Nochomovitz: That in today's slides, the MADIS trial shows eligibility spanning points four and five on that eight-point ordinal scale. So am I correct? Was there a change in the enrollment criteria for this one?

Things arent locked down people are continuing to get out we believe it can't get any worse than what it had been in 2020, particularly before the vaccinations for out there and so we do think that we have.

Wolfgang Dummer: I'll let Wolfgang answer that, but I think the answer is clear. Go ahead, Wolfgang. Yeah, it's a very, very sharp observation. The answer is no; there was no change in enrollment criteria; they're just the same. But it's a little bit of an artifact on the scale because the Imperial College of London uses a slightly different scale. And we used to think it was the equivalent of five, but now it has shifted by one, but this is simply due to the use of a slightly different scale that they're using. I think this is an accurate reference.

Great opportunity ahead of us to increase the noise level out there with total lease.

It is an unknown still obviously in terms of how much everything will open up but if the last quarter is any kind of a marker for that we did see a lot more in person interactions and we were able to make more impact for calls.

Both are in.

In sales calls and speaker programs in particular, and even seeing people at conferences and by the way.

Cash this year is a hybrid model.

Wolfgang Dummer: Okay, got it. And then just the last question I had on Rx14, what is the thinking behind the need to do a pro-drug formulation of R835 versus not? Okay. Yeah, so, as you know, we've shown you a lot of data about 835, which is a great molecule. We had preclinical experiments done with 835, as well as phase one healthy human volunteers. But it turns out that 289, which is cleaved and then, you know, results in the release of 835, has much better bioavailability and less variability in patients.

We'll be at least at this point a live conference in December for Ash, which I think is part of our planning as well we want to be prepared for that so I hope that I hope that helps.

Yeah, Yeah, that's definitely helpful.

And then it goes on.

1 other thing.

The folks we're bringing on in this expansion because as I told you we're already on our way with the expansion of the folks that we've already hired or who have accepted offers we have an average of 14 years of HELOC experience, which I think is going to help us a lot in in seeing.

Clinicians either virtually or live.

And you have to remember with our previous sales force size of 39.

When we brought people on they usually we're ending up calling on more customers than they used to in their previous or bigger geographies other than they used to in their previous roles at.

Wolfgang Dummer: So it's clearly a better compound to administer 835 to the patient. The active metabolite is still 835, so all the data that we have generated with 835 are still relevant. But it's a drug administration advantage for 289.

At an oncology company. So this really helps us to really be able as I said to see more customers and see them more frequently and hopefully be familiar with those customers, even with the new people coming in.

Yeah.

Wolfgang Dummer: And we were waiting to hear also from the FDA on 289, and there was an agreement that gave us the green light to proceed with this low-risk MDS study with 289. Got it. Thank you, Raul. Thank you, Yigal. The next question is from Chris Raymond of Piper Sandler. Please proceed with your question. Hi, this is Nicole Gabreski on behalf of Chris.

Okay. That's very helpful. Thank you.

And then maybe just a quick second question on your ongoing Covid studies I just wanted.

Wanted to ask if patients are being screened for viral strain and I guess I'm just kind of curious if there might be any differences in response to post imatinib treatment that could be dependent on current strain I'm, just especially now with the Doctor day, becoming dominant so any any thoughts or color here would be great.

Nicole Gabreski: Congratulations on the quarter and thanks for taking our questions. I guess maybe one on capillaries. So we're starting to hear more about potential commercial headwinds now with the Delta variant surging. I guess for your capillary growth expectations throughout the remainder of the year, does that take into account any potential COVID impacts? Or is it still too early on that?

Sure Wolfgang if you would comment on debt.

Yes. The answer is no there is no a screening for the for Varian It's lane.

But I.

I would I would be optimistic that the mechanism of action for close to him up in COVID-19 is independent of the stream because the public.

David A. Santos: Thank you, Nicole. I'll ask Dave to comment on that. Hi Nicole, this is Dave.

Physiology continues to be respiratory distress and respiratory problems. In these patients is really the is the tendency to get blood clothing in any launch missiles as well as into the smaller vessels, which leads to the renal failure and to other organ damage in.

David A. Santos: From a standpoint of the COVID Delta variant kind of affecting our ability to move forward, you know, I think we've been at least through the very rough storm of 2020, when things were locked down, and it was very difficult to go anywhere, as you know, and when you compare that to kind of where we are now, where, yes, you do have a Delta variant, but things aren't locked down, people are continuing to get out, And so we do think that we have a great opportunity ahead of us to increase the noise level out. It is still an unknown, obviously, in terms of how much everything will open up, but if the last quarter is any kind of marker for that, we did see a lot more in-person interaction. And we were able to make more impactful calls both...

And those and those should be inhibited with both of them us independent on what kind of variance we are dealing with.

Okay. Okay very helpful. Thank you very much.

Thank you Nicole.

The next question is from Gary mapping of BMO capital markets. Please proceed with your question.

Hi, This is Oh Wow I'm filling in for Gary Nachman. Thanks for taking my question. So my first question for Teva lease.

COVID-19.

Has there been any more progress with potential partners or discussions with regulatory authorities for ex U us in terms of Covid.

And secondly.

How do you view the opportunity now, especially with the increase.

And hospitalizations from the Doctor Darren Thanks.

Maybe I'll take a stab at the first of those Wolfgang you take us.

David A. Santos: Sales Calls and Speaker Programs, in particular. And by the way, you know, ASH this year is a hybrid model, but there will be, at least at this point, a live conference in December for ASH, which, you know, I think is part of our planning as well. We want to be prepared for that, so I hope that helps. Yeah, yeah, that's definitely helpful. I just want to add one more thing. The folks we are bringing on in this expansion because, as I told you, we're already on our way with the expansion.

Later on.

The U S. The opportunity is substantial as you may imagine I think for more advanced in the U in the U S simply because we've been on the market we've been we're well known entity here.

Where we have a significant safety database with our product here in the us and that's been our maintenance first focus but the opportunity with our partners exist and we're certainly discussing it with them and would move forward in those other territories as well to provide the product for you.

The us Fortunately is a the regulatory authorities move rather quickly relative to other countries. So it is the first priority for us.

David A. Santos: Of the folks that we've already hired or who've accepted offers, we have an average of 14 years of HEMOC experience, which I think is going to help us a lot in seeing clinicians either virtually or live. And you have to remember, with our previous sales force size of 39, when we brought people on, they usually ended up calling on more customers than they used to in their previous roles at an oncology company or bigger geographies than they used to in their previous roles at an oncology company.

Okay.

Hum on Covid you felt on the are you.

It can pull us Christian was around to increasing hospitalizations ER, yes. Indeed.

There was a concern there was concerns depending on on.

We look at it.

We thought maybe maybe the case numbers go down on it turns out to be.

A new variant, which is really a compatriot it turns out that only certain areas in the United States have very high vaccination rates for a while other areas have very small vaccination rates and this is where the cases go up I E.

David A. Santos: So this really helps us to be able, as I said, to see more customers and see them more frequently and, hopefully, become familiar with those customers, even with their current roles. Okay, that's very helpful. Thank you, and then maybe just a quick second question on your ongoing COVID studies. I just wanted to ask if patients are being screened for viral strain, and I guess I'm just kind of curious if there might be any differences in response to fostamatinib treatment that could be dependent on COVID strain, just especially now with the Delta variant becoming dominant. So any thoughts or color would be great.

I firmly believe that the issue is.

It's going to continue to stick around for quite a while.

With us today with Covid.

Current and nobody can predict for certain people that comes off the day.

We have already heard about it on the ovarian to in South America. So so I believe for them.

Continued need for for something that treats the disease effectively they'll be here for some of the.

Vaccinations now, but a lot of people on what vaccinated and studio kick in and they need they need to treatments and there'll be hoped we were going to be able to provide debt.

Yeah.

Thanks for thanks for the color.

Thank you.

The next question is from you on Yang of Jefferies. Please proceed with your question.

Hi, This is Alan on for you and I have 2 questions. Please number 1 on for way how would it be reasonable to assume enrollment completion by around net.

Wolfgang Dummer: Sure. Wolfgang, if you would please comment on that. Yeah, the answer is no; there is no screening for the variant at baseline. But I would be optimistic that the mechanism of action for fostamartinib in COVID-19 is independent of the strain because the pathophysiology continues to be respiratory distress and respiratory problems in this patient as well as a tendency to get blood clotting in larger vessels as well as in smaller vessels, which leads to renal failure and to other organ damage.

For Q 'twenty, 1 based on the most recent enrollment rates are around 2 to 3 patients per month.

Oh, I could take a step at that.

You know, it's hard to project and in the past we've had months, where we had more than 2 to 3 a month in months, where you have less than 2 to 3 a month and it really is.

Dependent on on a lots of things mainly COVID-19.

Kevin.

And so it's hard to project exactly when it will.

Wolfgang Dummer: And those should be inhibited with fostamartinib independent of what kind of variant we are dealing with. Okay, also very helpful. Thank you very much. Thank you, Duke Hall.

We'll enroll but we think later this year is the answer.

Keep in mind for.

Following many of our sites we have sites in the U S and we have sites in Europe. The preponderance are European and I do note that in Europe. The there's a higher vaccination rates now than in the US. So we're confident that that will help us in terms of recruitment in terms of patients going out there and seeing their doctors more frequently so it's.

Operator: The next question is from Gary Mappin of VMO Capital Markets. Please proceed with your question. Hi, this is Evan Kwa, filling in for Gary Nachman.

Well, it's hard to predict exactly the months, but we do know it's in the not too distant future. We only have approximately 10 more patients to go it's just not that many.

Evan Kwa: Thanks for taking my question. So my first question for Tavilis at COVID-19 is, has there been any more progress with potential partners or, you know, discussions with regulatory authorities for XUS in terms of COVID? And secondly, how do you view the opportunity now, especially with the increased number of hospitalizations from the Delta variant. Thanks. Maybe I'll take a stab at the first of those, Wolfgang, and you take the latter

Got it thank you and for the second question for Phase III and COVID-19.

Could you please provide a more defined timeline for on day to read out before it on your.

Year end 'twenty, 1 it looks like it took about 7 months to enroll 60% for vacation. So so we're probably expecting accelerated enrollment.

So how many percent such as site something activated so far.

Yeah, I think on the Covid side, we've actually enrolled very quickly in the last 2 months I think we've enrolled 90 patients that's about a patient on a half a day.

Raul R. Rodriguez: Outside the U.S., the opportunity is substantial, as you may imagine. I think we're more advanced in the U.S. simply because we've been on the market longer. We've been, we're a well-known entity here, where we have a significant safety database for our product here in the U.S., and that's been our main and first focus, but the opportunity with our partners exists, and we're certainly discussing it with them, and would move forward in those other territories, as well, to provide the product. The U.S., fortunately, regulatory authorities move rather quickly relative to other countries, so it is the first priority for us.

And so we started slowly.

When you initially started but there's been a real acceleration, particularly as we've gone to Latin America, Brazil and Argentina.

And as you May know, though the pandemic is raging in those countries. Unfortunately for them.

It has helped enrollment tremendously, though in terms of contributing patients to those U S sites as well and so we expect to have enrollment completed that's working on said by the end of this calendar year exactly the months is again, a little bit difficult to say because we don't know the trajectory of the pandemic kind of in reverse.

Of what I said earlier on on day IHA.

But it's certainly not subsiding in the countries, we're in Brazil, and Argentina in particular and in the U S. If anything it's increasingly on the short term.

Wolfgang Dummer: [inaudible] The second part of the question was around increasing hospitalizations. Yes, indeed. You know, there was a concern that was depending on, Now you look at it; we thought maybe the case numbers would go down. Now it turns out we have a new variant, which is very contagious. It turns out that only certain areas in the United States have very high vaccination rates, while other areas have very low vaccination rates, and this is where the cases go up.

And we think that will continue to maintain that very brisk rate of enrollment 19, now 2 months and we have 150 patients to go. So it gives you some estimate of that.

Got it.

If I may ask 1 more question. Please.

So it looks like a lot of that patient me coming from for South America aren't.

Are they spending.

With the standard of care in this country difference.

For the U S and how is how.

How are you thinking about how that would affect your results. Thank you.

I'll, let Alex what what's going on the comment, but I will make a comment other many other products that have.

Wolfgang Dummer: I firmly believe that the issue is going to continue to stick around for quite a while with the Delta variant, and nobody can predict with certainty what will come after that. We have already heard about the Lambda variant in South America, so I believe there is a continued need for something that treats the disease effectively, even though we have vaccinations now, but a lot of people are not vaccinated and still get sick, and they need treatment, and we hope we're going to be able to provide that.

R applied have applied Hep C D UA approvals or have done trials, primarily outside of the us in terms of this pandemic, which I think bodes well for us, but maybe Wolfgang do you want to comment in terms of standard of care U S purses.

I'll say Latin America.

Yeah, I would say.

Tony.

So it takes America zone. As you know is is widely used in debt is cheapened available everywhere in the world and that is also widely used in Latin America, where we are conducting a study maybe there might be some misuse of the rim desert view, which is not as widely Ah.

Evan Kwa: Thanks for the call, Ed. Thank you. The next question is from Eun Yang of Jefferies. Please proceed with your question.

Nalin Tejavibulya: Hi, this is Nalin speaking on behalf of Yoon. I have two questions, please. Number one, for Weiha, would it be reasonable to assume enrollment completion by around mid-year for Q21 based on the most recent enrollment rates of around two to three patients per month?

Available and stuff.

In South America, but we are so Mr. Edifying for debt. So we shouldn't have an.

On imbalance are in.

In all treatment arms, where with all of the room designee of patients on 1 arm and all of the multi room.

On the other all know there's gonna be equal percentages also you know if you. If you look at the Standalone room day debuted the EDA in hospitalized patients.

Raul R. Rodriguez: I could take a step at that. You know, it's hard to project. And in the past, we've had months where we had more than two to three cases a month and months where we had less than two to three cases a month. And it really is dependent on lots of things, mainly COVID-driven. And so it's hard to project exactly when it will enroll, but we think later this year is the answer. Keep in mind the following.

It's really you know the.

Fixed.

Modest at best I I computed the Pik modest so I didn't I do not really believe that a patient getting a M. Disabuse us as most getting when D. C Bureau is the ease of dramatically is a dramatically different patients and I'm very little concern.

Hum about this potential issue.

Thank you very much.

Thank you.

The next question is from Christian <unk> of Cantor Fitzgerald. Please proceed with your question.

Raul R. Rodriguez: Many of our sites; we have sites in the US, and we have sites in Europe, although the preponderance are European. And I do note that in Europe, there are higher vaccination rates now than in the U.S., so we're confident that that will help in terms of recruitment, in terms of patients going out there and seeing their doctors more frequently. So while it's hard to predict exactly the months, but we do know it's in the not-too-distant future. We only have approximately 10 more patients to go. It's just not that many.

Hi, good afternoon, everyone. Thanks for taking the questions. So the first is on top of a lease you've collected a lot of post hoc analysis data outside of just the earlier line response rate, but also I I S. T. H you showed a nice correlation with platelet counts along with reduced bleeding events and rescue therapy, and then I know on the.

Past, you've also had some data about the side effect profile lessening over time. So I just wanted to ask collectively have you as you've conducted more of this work along with the trial and some of your new marketing efforts. How do you believe that this is going to help you achieve not just earlier line usage, but also prolonged pieces.

Nalin Tejavibulya: Thank you. And for the second question, for phase three in COVID-19, could you please provide a more defined timeline for data readout before year end 21? It looks like it took about seven months to enroll 50% of the patients, so we're probably expecting accelerated enrollment. So how many percent of the sites have been activated so far?

Well and you know talk specifically about these new sales reps into new territories, and especially since they'll be going out with this message for the first time versus when you initially launched.

Absolutely Thanks, Chris and thank you for the question that's a very good 1 I'll let us.

Day to comment on that in terms of his thinking in terms of the various day doesn't he outlined today for you and.

Raul R. Rodriguez: Yeah, I think on the COVID side, we've actually enrolled very quickly. In the last two months, I think we've enrolled 90 patients. That's about one patient and a half a day.

You know the debt.

The new reps and what theyre going to us as the lead item as they introduce themselves to conditions Inc.

Raul R. Rodriguez: And so, we started slowly when we initially started, but there's been a real acceleration, particularly as we've gone to Latin America, Brazil, and Argentina. And as you may know, the pandemic is raging in those countries, unfortunately, for them. It has helped enrollment tremendously, though, in terms of contributing patients to those sites and the U.S. sites as well. And so, we expect to have enrollment completed, as Wolfgang said, by the end of this calendar year.

Yeah, Thanks for the message.

Question Kristen.

I think it is a great 1 because it is exactly why we are expanding and it's exactly.

What we've seen in our research as we talk to clinicians in different forums, both advisory boards as well as in.

In our more traditional market research and so the things that really appeals to them. Our R mechanism because it is different it goes right to.

Cause of low platelets in patients and of course for safety and efficacy and what we've really kind of focused on now is how do we make that efficacy message stronger and as he said our post hoc analysis on the early line data is you know.

Raul R. Rodriguez: Exactly how long the month is, again, a little bit difficult to say, because we don't know the trajectory of the pandemic, kind of in reverse of what I said earlier on AIHA. But it's certainly not subsiding in the countries we're in, Brazil and Argentina, in particular. And in the U.S., if anything, it's increasing in the short term. And we think that we'll continue to maintain that very brisk rate of enrollment, 90 in two months, and we have 150 patients to go. So, it gives you some estimate of that.

While it has been out since the beginning of 2020.

As you heard we're just not able to reach as many questions as we'd like and once they hear that data. They are they are quite surprised at our efficacy rates are response rates for that high in the earlier lines, but then now we're able to add this kind of durable benefit for.

For the majority of patients either getting over 50000, platelet level or getting over 30000, which many of them think it's clinically meaningful and when you. When you add that piece on there that 70% of patients can reach that clinically clinically meaningful level of 30000 and have a durable benefit over.

Nalin Tejavibulya: And if I may ask one more question, please. So it looks like a lot of the patients may come from South America. Are there standards? Would the standards of care in those countries be different in the U.S., and how are you thinking about how that would affect the results? I'm going to ask Wolfgang DeKalb.

It really does ring true and so what we're doing is we're using both of these tools the BCH publication as well as his 5 year efficacy and safety analysis to really.

Raul R. Rodriguez: I'll ask Wolfgang to comment, but I will make a comment. Many other products that are being used, have been applied for, have received EUA approvals, have done trials primarily outside of the U.S. in terms of this pandemic, which I think, you know, bodes well for us. But maybe, Wolfgang, do you want to comment in terms of the standard of care in the U.S. versus, say, Latin America? Yeah, I would say, The only, so dexamethasone, as you know, is widely used and that is cheap and available everywhere in the world.

Get out they're strong.

In terms of when they see a patient that they want to start.

Steroids or switch.

They really have an opportunity with total lease end.

We hear it over and over again.

The docks.

When they hear about it.

Try it and they have a good experience I mean this drug is a a safe dragged on used.

A lot in other areas.

Very safe and in a very effective.

I. It was it was funny, we were just talking about it at a meeting today I guess, it's it's a drug that is easy for them to give to just give it twice a day and they are they can watch their patients continue to build their platelet counts and have durable responses over time, that's exactly what the new reps are going to do it we're going to have them trained and.

Raul R. Rodriguez: And that is also widely used in Latin America, where we're conducting our study. Maybe there might be some less use of remdesivir, which is not as widely available in that. South America, but we are stratifying for that, so we shouldn't have an imbalance in our treatment arms where all of the remdesivir patients are in one arm and all of the not remdesivir patients are in the other arm. No, there's going to be equal percentages.

On this area and they're gonna be kind of re launching what we've had before with the early I find data and we just trained our entire sales force on that.

No.

The 5 year efficacy and safety analysis with the durable benefit and we think that message will ring true when it's out there and it's going to be in our speaker programs are everything that we're doing to get the message out there.

Raul R. Rodriguez: Also, you know, if you look at the standalone remdesivir data in hospitalized patients, the effect is really modest at best. I consider the effect modest at best, so I do not really believe that a patient getting remdesivir versus not getting remdesivir is a dramatically different patient, so I'm very little concerned about this potential issue.

Great. Thank you and just a quick follow up on that can you talk a little bit more about the new 16 territories and specifically what criteria.

Choosing these I think it says in the slides that some of these are smaller territory. So how are you thinking about things like competitive positioning.

Wolfgang Dummer: Thank you very much. Thank you. The next question is from Kristen Kluska of Cantor Fitzgerald. Please proceed with your question.

Sure.

We chose the 16 territories.

Kristen Brianne Kluska: Hi, good afternoon, everyone. Thanks for taking the questions. So the first is Tavalese. You've collected a lot of post-hoc analysis data outside of just the earlier line response rates, but also at ISTH, you showed a nice correlation with platelet counts along with reduced bleeding events and rescue therapy. And then, in the past, you've also had some data about the side effect profile lessening over time. So I just wanted to ask collectively, as you've conducted more of this work, along with the trial and some of your new marketing efforts, how do you believe that this is going to help you achieve not just earlier line usage but also prolonged...

Based on the number of prescribers that a territory as well as the opportunities in terms of CIP TP claims that are there in that territory. So it's a mix of potential as well as for prescribers and we balance all of the territories across 55 asbestos, we kit, but it makes it much more.

Uh huh.

Many of our territories that were existing before of the 39 were just simply very large geographies that was difficult to get that frequency.

That you would like to have on some of the key prescribers in the territory and so what we've done is we've reduced the size of some of these large geographies.

Pretty dramatically with this increase in size of the sales force I hope that makes sense.

David A. Santos: new sales reps in the new territories, especially since they'll

Yes, thanks I appreciate that.

David A. Santos: I will be going out with this message for the first time.

The next question is for Joe Pat Guinness of H C. Wainwright. Please proceed with your question.

David A. Santos: Time versus when you initially launched.

David A. Santos: Initially launched. Absolutely. Kristen, thank you for the question. That's a very good one. I'll ask Dave to comment on that in terms of his thinking, in terms of the various data that he outlined today for you, and, you know, the new reps and what they're going to use as a lead item as they introduce themselves to clinicians. Dave?

Hey, guys. Good afternoon, I have 2 quick I guess logistical questions on Covid and then 1 on I T. P. So on the Covid front I was just curious regarding active for and when you look at the ordinal scale and I guess, a little bit of a difference if it's different or is it just a wording difference with regard to the primary endpoint.

David A. Santos: Thanks for the question, Kristen. I think it is a great one because it's exactly why we are expanding and it's exactly what we've seen in our research as we talk to clinicians in different forms, both in advisory boards as well as in more traditional market research. And so the things that really appeal to them are our mechanism because it is different. It goes right to the cause of low platelets in patients.

When you talk about active for in your slides here, it's you know between 5 and 7.

But the end point says you know requiring supplemental oxygen by day 28, whereas something like active 5 has a primary endpoint of survival without ventilation at day 28, even though you're really covering the the 3 numbers. There I was just curious if there's differences.

Yeah Wolfgang.

If you would take that out you could also add in.

David A. Santos: And, of course, safety and efficacy. And what we've really kind of focused on now is how do we make that efficacy message stronger? And as you said, our post-hoc analysis on the early line data is, you know, while it has been out since the beginning of 2020, we, as you heard, we're just not able to reach as many clinicians as we'd like. And once they hear that data, they are quite surprised that our efficacy rates, our response rates are that high in the earlier lines.

Yeah, So when I see the population is a similar to NIH you all correct, it's not identical because the active for isn't isn't using debt or do you know scale is the inclusion criteria. They have other criteria like us.

You can reopen.

Spirits, where you're familiar and things like that but in essence. These all patients that are hospitalized and they need they need to oxygen supplementation. So they are quite similar.

To your point regarding the.

David A. Santos: But now we're able to add this kind of durable benefit for the majority of patients, either getting over 50,000 platelet levels or getting over 30,000, which many of them think is clinically meaningful. And when you add that piece on there, that 70% of patients can reach that clinically meaningful level of 30,000 and have a durable benefit over time, it really does ring true. And so what we're doing is we're using both of these tools, the BGH publication as well as this five-year efficacy and safety analysis, to really, you know, get out there strong in terms of, you know, when they see a patient that they want to start on post-steroids or switch, they really have an opportunity with Tavalese.

Oxygen endpoint are indeed, our debt is 1 that's not always been used but it has been used increasingly in these NIH studies and also by the other thing therefore, they have selected us as an endpoint that they think is is reliable clean measurable us.

It seemed to Tus and is a clinically meaningful but.

Comments or or appropriate in our current got it got it and then with regard to the your phase III. Obviously, you said its U S and South America. I was just curious can you provide any sort of approximate proportion between the 2 regions of enrolled patients.

Yeah the majority.

I can share with you right now is coming from South Americas are just simply due to the into them too.

David A. Santos: And, you know, we hear it over and over again that doctors, you know, when they hear about it, they try it, and they have a good experience. I mean, this drug is a safe drug that has been used a lot in other areas and is very safe and, in ITP, very effective. And so it was funny; we were just talking about it at a meeting today. I guess it's a drug that is easy for them to give.

Oh for disease in these areas, but we do get you do get patients from our U S sites as well.

Got it got it and then my T. P question I get it still might be a little early to ask this but it's very nice to hear about the sales force expansion as well as the increased face to face meeting. So that's very good to hear I guess I would ask again might be too early do you have any anecdotes or feedback to share from the field.

Kristen Brianne Kluska: They just give it twice a day, and they can watch their patients continue to build their platelet counts and have durable responses over time. So that's exactly what the new reps are going to do. We're going to have them trained in this area, and they're going to be kind of relaunching what we had before with the early lifeline data. And we just trained our entire sales force on the five-year efficacy and safety analysis with the durable benefit, and we think that message will ring true when it's out there.

Now with regard to physician or nurse practitioner nurse receptivity to the earlier stage data.

Hey, do you want to take a stab at us.

Sure.

Actually it's a timely question because I am here with the team and we're just kind of going through some of these.

All items that I've talked to you about and they were talking about how when they are able to get in front of a dock and present, the message and really get.

Get that out there in front of them they are enthusiastic about it and.

David A. Santos: And it's going to be in our speaker programs, everything that we're doing to get the message out there. Great, thank you. And just a quick follow-up on that. Can you talk a little bit more about the new 16 territories and specifically what criteria went into choosing these? I think it says in the slides that some of these are smaller territories. So how are you thinking about things like competitive positioning?

We see this over and over in our research forums as well you know docs have really no.

Issues with profit leaks when they look at the data. That's there it's really just as I said on the last call. It's an issue of habit and they just need to have probably us top of mind when they see Ah I.

Ah patients that they are ready to start to switch and that's what we're doing as you know there are 24000 patients out there post steroids and if you just even match in a fraction of them at any given time.

David A. Santos: Now we chose the 16 territories based on the number of prescribers in a territory as well as the opportunities in terms of CIT. So it's a mix of potential as well as prescribers, and we balanced all of the territories across the 55 as best as we could, but it makes it much more interesting; many of our territories that were existing before the 39 were just simply very large geographies. It was difficult to get that frequency that you would like to have with some of the key prescribers in the territory, and so what we've done is we've reduced the size of some of these large geographies pretty dramatically with this increase in the size of the sales force.

Ready to start or switched therapies.

Not to mention all the patients who are watchful waiting.

Good cycle in and out it's a lot of opportunity out there and so we just need to be out there more with the Massachusetts stays top of mind. So when the clinician sees that patient they are ready to pull the trigger with totally so I really believe in that and that's why we did expand our sales force and we are getting good feedback on those.

Efficacy messages.

Got it guys. Thanks for the feedback.

Thank you Joe.

That's all the time, we have for questions today, I would like to turn on the floor back over to Mr. Raul Rodriguez for closing comments.

Thank you everyone. Thank you for those questions very much appreciate it.

David A. Santos: I hope that makes sense. Yes, thanks. Appreciate that. The next question is from Joe Pantginis of HC Wainwright. Please proceed with your question. Hey, guys. Good afternoon.

I'd like to just take that you take the opportunity to thank all our employees are this has been a challenging time for all of us and they've done an incredible job and are exploring the potential for the use of post imatinib Televisa AIA chain.

Joseph Pantginis: I have two quick, I guess, logistical questions on COVID and then one on ITP. So, on the COVID front, I was just curious regarding ACTIV-4 and when you look at the ordinal scale, and I guess a little bit of a difference, if it's different, or is it just a wording difference with regard to the primary endpoint? So, when you talk about ACTIV-4 in your slides here, it's, you know, between 5 and 7, but the endpoint says, you know, requiring supplemental oxygen by day 28, whereas something like ACTIV-5 has a primary endpoint of survival without ventilation at day 28, even though you're really covering the three numbers there. I was just curious if there were any differences. Yeah, looking up, if you would take that, I could also add in.

Our COVID-19 and and allowing or educating doctors about the use of the I T. P. All of that work are difficult to do during these conditions, but they persevere than that and I'd like to thank them for that I think we've made very good progress this past quarter and we have some incredible milestones coming in the short term debt.

We will reveal the utility of our product for that and so I'd like to do it with that thank you for your participation on interest in Rigel, and we certainly look forward to giving you further updates in the near term picture.

Yeah.

Okay.

[music].

Wolfgang Dummer: Yeah, so when I say the population is similar to NIH, you are correct, it's not identical, because the ACTIV-4 isn't using that ordinal scale as the inclusion criteria. They have other criteria like a certain degree of respiratory failure and things like that. But in essence, these are patients that are hospitalized, and they need oxygen supplementation, so they're quite similar. To your point regarding the oxygen endpoint, indeed, that is one that hasn't always been used, but it has been used increasingly in these NIH studies and also by others, and therefore, they have selected this as an endpoint that they think is reliably measurable, is sensitive, and is clinically meaningful.

Wolfgang Dummer: But your comments are appropriate. Got it, got it. And then, with regard to your Phase 3, obviously you said it was the U.S. and South America. I was just curious, could you provide any sort of approximate proportion between the two regions?

Wolfgang Dummer: of Enrolled Patients. Yeah, the majority I can share with you right now are coming from South America, just simply due to the incidence of the disease in these areas, but we do get patients from our U.S. sites as well. Got it, got it.

Joseph Pantginis: And then my ITP question: it still might be a little early to ask this, but it's very nice to hear about the Salesforce expansion as well as the increased face-to-face meetings. So that's very good to hear. I guess I would ask, again, maybe it might be too early. Do you have any anecdotes or feedback to share from the field now with regard to physician or nurse practitioner or nurse receptivity to the earlier stage data? Dave, would you like to take a stab at this?

David A. Santos: Sure. Actually, it's a timely question because I am here with the team and we're just kind of going through, you know, some of these promotional items that I've talked to you about. And they were talking about how when they are able to get in front of a doctor and present the message and really, you know, get that out there in front of them, they are enthusiastic about it. And again, we see this over and over in research forums as well. You know, doctors really have no issues with Tavalese when they look at the data that's there. It's really just, as I said on the last call, it's an issue of habit.

David A. Santos: And they just need to have Tavalese top of mind when they see a patient that they're ready to start a switch. And that's what we're doing. As you know, there are 24,000 patients out there post-steroids. And if you just even imagine a fraction of them at any given time ready to start or switch therapies, not to mention all the patients who are waiting and who could cycle in and out, there is a lot of opportunity out there. And so we just need to be out there more with the message so it stays top of mind. So when the clinician sees that patient, they're ready to pull the trigger on Tavalese.

David A. Santos: So I really believe in that Sales Force, and we are getting good feedback on those efforts. Got it guys, thanks for the feedback. Thank you, Joe. That's all the time we have for questions today.

Operator: I would like to turn the floor back over to Mr. Raul Rodriguez for closing comments. Thank you, everyone. Thank you for those questions. Very much appreciated. I'd like to just take the opportunity to thank our employees. This has been a challenging time for all of us, and they've done an incredible job exploring the potential for the use of fostered matinib, tavalis, and AIHA in COVID and allowing or educating doctors about the use in ITP.

[music].

Operator: All of that work is difficult to do under these conditions, but they persevered in that, and I'd like to thank them for that. I think we've made very good progress this past quarter, and we have some incredible milestones coming in the short term that I think will reveal the utility of our product for that. And so, with that, thank you for your participation and interest in Rigel, and we certainly look forward to giving you further updates in the near term. Take care.

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