Q1 2021 Deciphera Pharmaceuticals Inc Earnings Call

Good afternoon, everyone and welcome to this I feel pharmaceuticals first quarter of 2021 financial results Conference call.

Unknown Executive: Good afternoon, everyone, and welcome to Deciphera Pharmaceuticals' first quarter 2021 financial results conference call. Today's call has been recorded. At this time, I would like to hand the conference over to Jen Robertson, Vice President, Investor Relations. You may begin. Thank you, Tawanda.

Today's call is being recorded.

At this time I would like to him to conference over to Jim Robertson, Vice President's Investor Relations you may begin.

Thank you too Rhonda welcome and thank you for joining us today to discuss the Cyprus first quarter 2021 financial results I'm, John Robinson, Vice President Nestor relations at decipher up with me. This afternoon to discuss the financial results and provide a general corporate update or Steve harder, President and Chief Executive Officer.

Jennifer Larson: Welcome, and thank you for joining us today to discuss Deciphera's first quarter 2021 financial results. I'm Jen Robinson, Vice President of Investor Relations at Deciphera. With me this afternoon to discuss the financial results and provide a general corporate update are Steve Hoerter, President and Chief Executive Officer, Dan Martin, Chief Commercial Officer, Matt Sherman, Chief Medical Officer, and Tucker Kelly, Chief Financial Officer. Before we begin, I would like to remind you that any statements we make on this call that are not historical facts are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Yeah, Martin Cheap commercial officer, Matt Sherman, Chief Medical Officer, and Tucker Kelly Chief Financial Officer before we begin I would like to remind you that any statements that we make on this call that are not historical facts are forward looking statements, reflecting the current beliefs and expectations on management may pursue much the safe Harbor provisions.

The private security Litigation Reform Act of 1995.

Examples of forward looking statements made during this conference call include our expectations for our preclinical and clinical programs are commercialization of Kinloch and 2021 guidance forward looking statements made on this call involved substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward looking stay.

Jennifer Larson: Examples of forward-looking statements made during this conference call include our expectations for our pre-clinical and clinical programs, our commercialization of Kenloch, and 2021 guidance. Forward-looking statements made on this call involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statement. And we cannot assure you that our expectations will be achieved. Such risks and uncertainties include those set forth in our most recent quarterly report on Form 10-Q, as well as in our other SEC filings. We assume no obligation to update or revise any forward-looking statements.

Eight minutes.

And we cannot assure you that our expectations will be achieved such risks and uncertainties include those set forth in our most recent quarterly report on form 10-Q, as well as our other <unk> filings, we assume no obligation to update or revise any forward looking statements. Following this call a replay will be available on the company's website W. W. Dot net.

Unknown Executive: Following this call, a replay will be available on the company's website, www.decipher.com. I will now turn the call over to Steve Hoerter, President and Chief Executive Officer of Deciphera. Thank you, Jen.

Seifer Dot com.

Now turn the call over to Steve harder, President and Chief Executive Officer of decipher a steep.

Thank you Jim it's been an exciting start to the year 40 sofa as you build upon older. We accomplished in 2020 and execute in our strategic priorities across the portfolio from 2021, we.

Steven L. Hoerter: It's been an exciting start to the year for Deciphera as we build upon all that we accomplished in 2020 and execute on our strategic priorities across the portfolio for 2021. We continue to make great progress against the three areas of focus for Kinloch this year. They successfully launched Kinloch in the U.S., expanding the geographic reach of Kinloch by seeking regulatory approvals around the world, and moving Kinloch into earlier lines of therapy in GIST.

We continue to make great progress against the three areas of focus for 10 o'clock this year.

Absolutely Washington lock on the U S. Expanding the geographic reach you can walk by seeking regulatory approvals around the world and moving can log into earlier bowling just therapy and just.

Are successful loss of Kim lock on the U S demonstrates the significant on the medical need and fourth one just and the potential for Kim off to offer a meaningful difference for patients in the study.

Steven L. Hoerter: Our successful launch of Kenlock in the U.S. demonstrates the significant unmet medical need for this therapy and fourth-line gist and the potential for Kenlock to offer a meaningful difference for patients in this setting. In a few minutes, Dan Martin, our Chief Commercial Officer, will outline our success in quickly establishing Kenlock as the standard of care in its approved indication. Our rapid penetration of this market and the very positive perceptions of Kinloch by JustTreaters create a solid foundation for our potential future expansion into the second line setting.

In a few minutes <unk> commercial officer will outline Oh success and quickly establishing kinlaw cause the standard of care I mean, it's approved indication on.

Ah rapid penetration of this market and the very positive perceptions of Kinloss I, just treaters create a solid foundation for our potential future expansion into the second one seven.

And the first quarter, we made important progress on or go to expand the geographic Richardson walk on a partner in greater China design lab received approval for Kim on from both the China National Medical products administration and of the Hong Kong Department of Health.

Steven L. Hoerter: In the first quarter, we made important progress on our goal to expand the geographic reach of Kinloch. Our partner in Greater China, Xi Lab, received approval for Kinloch from both the China National Medical Products Administration and the Hong Kong Department of Health. An estimated 30,000 new patients are diagnosed with JIS in China each year, and we look forward to supporting Xi as they launch Kinloch in China later this quarter.

An estimated 30000, new patients are diagnosed with just and trying to each year and we look forward to supporting guy cause they launch can walk in China later this quarter.

We expect to receive approval for 10 lock from the European Medicines agency in the fourth quarter of this year, because we are weighted action from the email we are actively laying the groundwork for a commercial organisation in Europe and building an experienced and focus team that will allow us to quickly deliver can lots of patience and key markets once approved.

Steven L. Hoerter: We expect to receive approval for Kenlock from the European Medicines Agency in the fourth quarter of this year. As we await action from the EMA, we are actively laying the groundwork for our commercial organization in Europe and building an experienced and focused team that will allow us to quickly deliver Kenlock to patients in key markets once approved. As the first drug specifically designed to treat GIST, we believe Kenloch has the potential to fundamentally alter the treatment of this disease.

That's the first strike specifically designed to treat just we believe can lock has the potential to fundamentally ultra the treatment of this disease one of the key elements of our strategy to expand the use of can walk into earlier ones. The treatment as our ongoing phase three study intrigue and the second one seven.

Steven L. Hoerter: One of the key elements of our strategy to expand the use of Kenloch into earlier lines of treatment is our ongoing Phase III study, Intrigue, in the second-line setting. We expect to announce top line results for Entree in the fourth quarter of this year.

We expect to announce top one results for entry in the fourth quarter of this year.

And beyond the entry study, we're pursuing additional opportunities to benefit patients with just by evaluating the use of kinloch as a backbone of a treatment combination that seeks to address one of the potential mechanisms of resistance to kit inhibition reactivation of the map kind of pathway.

Steven L. Hoerter: And beyond the intrigue study, we are pursuing additional opportunities to benefit patients with GIST by evaluating the use of Kinloch as the backbone of a treatment combination that seeks to address one of the potential mechanisms of resistance to kit inhibition, reactivation of the MAP kinase pathway. Matt Sherman, our chief medical officer, will discuss in more detail later in the call our plan to initiate later this year a Phase 1B2 study of Kinloch in combination with Benimetinib, an approved MEK inhibitor.

That Sherman, our Chief Medical Officer will discuss in more detail later on the call or plan to initiate later this year a phase one b to study of Kinloch in combination with any med net and approved mechanism it or.

Finally, we remain very excited about are expanding pipeline of Chinese inhibitors beyond can lock throughout 2021, we expect to have significant clinical and regulatory updates. The we believe have the potential to create significant value for shareholders. As we continue to deliver on our mission of discovering developing in commercializing new medicine.

Steven L. Hoerter: Finally, we remain very excited about our expanding pipeline of kinase inhibitors beyond Kenley. Throughout 2021, we expect to have significant clinical and regulatory updates that we believe have the potential to create significant value for shareholders as we continue to deliver on our mission of discovering, developing, and commercializing new medicines for patients with cancer. I'll now turn the call over to Dan Martin, our Chief Commercial Officer, to discuss the U.S. Kenloch commercial results from Q1.

For patients with cancer.

I will now turn the call over to Dan Martin are cheap commercial officer to discuss the U S can lock commercial results from Q1 day.

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Thank you Steve Good afternoon today I'm pleased to report the results of our third full corner of Kinloch sales and to provide additional color regarding your expectations as we look ahead.

Daniel C. Martin: Thank you, Steve. Good afternoon. Today, I'm pleased to report the results of our third full quarter of Kinloch sales and to provide additional color regarding our expectations as we look ahead. We continue to be very pleased with the Kinloch launch, including a rapid penetration of the fourth line opportunity and the overwhelmingly positive response we have received from Just Treaters. In Q1, we achieved $20 million in total net product revenue, including $19.3 million in the U.S., bringing total launch-to-date U.S. net product revenue to $57.3 million.

We continue to be very pleased with the kinloch launch, including a rapid penetration on the fourth one opportunity and the overwhelmingly positive response, we received from just treaters and cute one we achieved $20 million in total net product revenue, including 19.3 million in the U S. Bringing total lunch today you ask me.

Product revenue to $57.3 million.

As we have share previously prior to launch our goals would rapidly establish can lock on the standard of care in our initial for fine indication.

Daniel C. Martin: As we have shared previously, prior to launch, our goals were to rapidly establish Kinloch as the standard of care in our initial fourth-line indication while building clinical experience and positive product perceptions among a broad prescriber base in advance of a potential launch into the larger second-line opportunity. Thanks to the continuing efforts of our cross-functional teams to navigate the unprecedented challenges of the COVID-19 pandemic, we have continued to make excellent progress toward these goals. Our recent market research indicates that commercial execution was again a strong point in Q1.

While building clinical experience in positive product perceptions I'm on the broad prescriber base in advance of a potential launch into the larger second line opportunity.

Thanks for the continuing efforts of our cross functional teams to navigate the unprecedented challenges at the COVID-19 pandemic, we've continued to make excellent progress toward these goals.

A recent market research indicates that commercial execution was again, a strong point and if you want.

Despite the continuing need to operate largely through a virtual model our sales and marketing teams maintained high levels of prescriber reach frequency and share voice and grew on prescriber base to over 400 prescribers from more than 350 institutions since lunch.

Daniel C. Martin: Despite the continuing need to operate largely through a virtual model, our sales and marketing teams maintained high levels of prescriber reach, frequency, and share of voice and grew our prescriber base to over 400 prescribers from more than 350 institutions since launch. Additionally, despite having limited opportunities for in-person meetings, our sales team has established an excellent reputation among GIST-treating physicians. In a recent blinded survey, GIST prescribers cited the Decipher sales team as best-in-class among companies in the GIST market and ranked the team first across every performance metric evaluator. Our market research also shows that this continued strong execution has had a clear impact.

Despite having limited opportunities for in person meetings. Our sales team is establish an excellent reputation among just treating physicians and a recent blinded survey just prescriber cited the decipher sales team as best in class among companies on but just market and ranked the team first across every performance metrics evaluated.

Market Research also shows that this continued strong execution has had a clear impact kinloch awareness and familiarity of them prescribers treating fourth line just remained extremely high and just treaters again reported very positive perceptions of <unk> clinical attribute.

Daniel C. Martin: Kinloch awareness and familiarity among prescribers treating fourth-line GIST remained extremely high, and GIST treaters again reported very positive perceptions of Kinloch's clinical attributes. In a recent survey, nearly 90% of all GIST prescribers and 100% of physicians who have prescribed Kinloch agreed that Kinloch is the standard of care in fourth-line GIST. Furthermore, among physicians who initiated a fourth-line GIST treatment within the prior 90 days, nearly all prescribed Kenlon.

In a recent survey nearly 90 per cent of all just treaters and 100 per cent of physicians, who are prescribed kinloch agreed that can lock as the standard of care in fourth one just.

Further among physicians, who initiated it for fun just treatment within the prior 90 days nearly all had prescribed cannot.

In addition to the strong performance of our sales and marketing teams or market access team continued to deliver broad patient access to can lock and key you want.

Daniel C. Martin: In addition to the strong performance of our sales and marketing teams, our market access team continued to deliver broad patient access to Kinloch and Q1. Payor coverage for Kinloch remained very positive, with policies aligned to our FDA label. During the quarter, the percentage of patients that received free drugs under our patient assistance program, or PAP, was at the low end of our estimated range of 20 to 30 percent.

Pay your coverage for Kinloch remained very positive with policies are lying to her F. C a label.

During the quarter the percentage of patients that receive free drug under our patient assistance program work half was at the low end of our estimated range of 20 to 30 per cent.

Prior to launch data from the Invictus study gave us confidence that kinloch had the potential to transform the treatment of advanced just now early data from our fourth line launch is providing insight into how can lock is benefiting patients on the real world setting.

Daniel C. Martin: Prior to launch, data from the INVICTUS study gave us confidence that Kinloch had the potential to transform the treatment of advanced GIST. Now, early data from our fourth-line launch is providing insight into how Kinloch is benefiting patients in the real-world setting. Though it's still early days, and the data are still maturing, the real-world persistency that we see for patients who have received Kinloch since launch is similar to what we saw in the Invictus study, consistent with our pre-launch expectations.

No. It's still early days and the data are still maturing the real world persistency that we see for patients who have received can lock since launch is similar to what we saw on invictus studying consistent with our prelaunch expectations.

Ultimately based on data from my clinical trials, we would expect the average time on therapy to be somewhat longer than the median due to the impact of long responders.

However, it will take time for this day to to mature and it's still too early to know how this trend will play out in the real world settings.

Daniel C. Martin: Ultimately, based on data from our clinical trials, we would expect the average time on therapy to be somewhat longer than the median due to the impact of long responders. However, it will take time for this data to mature, and it's still too early to know how this trend will play out in the real world setting.

In terms of broader market dynamics, we may now be seeing more clearly the impact of the pandemic is having an oncology and specifically and just <unk>.

Data from my Q V. A show that the pandemic has had a persistent negative impact on oncology diagnosis visit since Q2 of last year and I Q V. A project that this impact is likely to continue on to come in months.

Daniel C. Martin: In terms of broader market dynamics, we may now be seeing more clearly the impact that the pandemic is having on oncology and specifically in jails. Data from IQVIA show that the pandemic has had a persistent negative impact on oncology diagnosis visits since Q2 of last year, and IQVIA projects that this impact is likely to continue in the coming months. Further, a recent analysis of claims data for earlier-line GIST patients showed a decline in new patient volume over the past year of approximately 10%.

Further a recent analysis of claims data for earlier line just patients showed a decline in new patient volume over the past year have approximately 10 per cent.

This trying to something that we will continue to assess as it could impact the volume of patients progressing to four find treatment this year.

These data on a consistent with our discussions with just thought leaders, who indicate that patient volume and referral patterns have been inconsistent during the pandemic.

Given kinloss rapid penetration of the fourth line opportunity as well as the uncertainty impact that the pandemic may continue to have in the near term, we expect the opportunity for growth to be limited until we were able to expand to the second line setting pending positive data from intrigue and subsequent approval.

Daniel C. Martin: This trend is something that we will continue to assess as it could impact the volume of patients progressing to fourth-line treatment this year. These data are consistent with our discussions with thought leaders who indicate that patient volume and referral patterns have been inconsistent during the pandemic.

As we've discussed we believe the opportunity for Kinloch is substantially larger on the second line compared to our initial fourth line indication.

Daniel C. Martin: Given Kinloch's rapid penetration of the fourth line opportunity, as well as the uncertain impact that the pandemic may continue to have in the near term, we expect the opportunity for growth to be limited until we are able to expand into the second line setting pending positive data from intrigue and subsequent approval. As we have discussed, we believe the opportunity for Kinloch is substantially larger in the second line compared to our initial fourth line indication.

This is driven by a larger estimated incident patient population as well as the fact that patients may experience increased clinical benefit and longer time on therapy, when they receive kinloch earlier in the course of disease.

As we share it previously we believe the distribution of patients on the second line, it's weighted more heavily towards the community setting.

When compared to four find patients.

With this in mind, we are extremely pleased to see that while academic prescribers made up the majority of our earliest adopters. We've also made tremendous progress in the community.

Daniel C. Martin: This is driven by a larger estimated incident patient population, as well as the fact that patients may experience increased clinical benefit and longer time on therapy when they receive Kinloch earlier in their course of disease. As we have shared previously, we believe the distribution of patients in the second line is weighted more heavily toward the community setting when compared to fourth-line patients.

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More than half of Kinloch treated patients and 70 per cent of new prescribers came from the community setting.

We believe our diverse prescriber base across both academic and community settings on the awareness. He positive perceptions. We have established among just triggers more broadly positions us extremely well for a potential future second line launch.

Matthew L. Sherman: With this in mind, we are extremely pleased to see that while academic prescribers made up the majority of our earliest adopters, we have also made tremendous progress in the community. In Q1, we estimate that more than half of Kinloch's treated patients and 70% of new prescribers came from the community setting. We believe our diverse prescriber base across both academic and community settings and the awareness and positive product perceptions we have established among GIST treaters more broadly positions us extremely well for a potential future second-line launch.

Moving forward our focus on the U S will continue to be on optimizing our fourth line business wallet same time, initiating our launch preparations for a potential approval and the second line.

Can luck has already found.

Can luck has already had a profound impact on the treatment of advanced yes, and we were extremely motivated by the potential opportunity to help patients even earlier in the course of disease. When they may benefit most I will now turn on the call over to Matt Sherman to discuss the progress of are clinical programs Matt.

Thank you Dan Steve mentioned remain focused on demonstrating too much profile cause a best in class pull up scripts from kitten inhibitor vanilla ongoing free free true so the compared to on 222 submitted from patients with a second one just.

Matthew L. Sherman: Moving forward, our focus in the U.S. will continue to be on optimizing our fourth-line business while, at the same time, initiating our launch preparations for a potential approval in the second line. Kinloch has already found, Ken Luck has already had a profound impact on the treatment of advanced, And we are extremely motivated by the potential opportunity to help patients even earlier in their course of disease when they may benefit most. I will now turn the call over to Matt Sherman to discuss the progress of our clinical programs. Matt?

This on the progress of the intrigues study, we expect to know it's tough one day that in fourth quarter of this year.

We remain very optimistic book potential for too long to demonstrate superiority over Susan <unk> basically storm results from a phase one study.

For too much for the medium progression pieces liable with 10.7 months from second long patients.

We believe that to demonstrate clinically meaningful goodness isn't in free.

We'll need to show two to three months increase in PSS relative to be expected pieces for the submit this form of approximately six months.

Finally, we believe that the exceptional results from this is three and took the study showing a medium psf's from 6.3 months for 20, plus just patients receiving kinloch strongly supports the likelihood of success and intrigue.

Matthew L. Sherman: Thank you, Dan. As Steve mentioned, we remain focused on demonstrating Kinloch's profile as a best-in-class broad-spectrum kit inhibitor in our ongoing phase 3 intrigue study comparing Kinloch to 2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2- We remain very optimistic about the potential for Kinloch to demonstrate superiority over Supnit-Nip based on the strong results of the Phase I study, where Kinloch showed a median progression-free survival of 10.7 months in second-line patients.

We are excited to announce today, our plans to initiate the phase wouldn't be too. So that you can log in combination with many <unk> and improved neck inhibitor to address one of the potential assistance mechanisms on just.

Despite the business at the can lock and other approved kittens <unk> provide so many just patients resistance remain for some this can challenge we have lost the other <unk> pathway ambition might increase responses interest patients.

Go with a new study is to see whether we can deep at the input long initial responses, but combining brought kitten edition from two months with an addition on the map <unk> pathway using a <unk>.

First one amendment has proven to be effective and stabilize from disease progression, most just patients, but less than 10 per cent of patients experienced complete regression.

Just want somebody comes on that mood resistance. After clearing secondary mutations most often didn't care for that kind of pathway can be reactivated increasing kitten expression.

Matthew L. Sherman: We believe that to demonstrate clinically meaningful benefit and intrigue, we will need to show a two to three month increase in PFS relative to the expected PFS for the student arm of approximately six months. Finally, we believe that the exceptional results of the Phase 3 Invictus Study, showing a median PFS of 6.3 months in fourth-line plus chest patients receiving Kinloch, strongly support the likelihood of success and intrigue. We are excited to announce today our plans to initiate a Phase 1B2 study of Kinloch in combination with BiniMetNib, an improved MEK inhibitor, to address one of the potential resistance mechanisms in jets.

These patients experienced progressive disease, but no longer response to that mood treatment.

Herpes won't be too clinical study the supported by exciting preclinical day that there was recently published on line the molecular cancer therapeutics as well as preclinical day. The present your T. C. M. C. I C. C. R meeting in 2018, showing the treatment Kinloch in combination with Nick inhibitors set.

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In addition can want demonstrated superior accuracy, two and that combination nothing hitters.

Matthew L. Sherman: Despite the benefit that Kinloch and other approved kit inhibitors provide for many chest patients, resistance remains a significant challenge, and we have long thought about how dual pathway inhibition might increase responses in chest patients. The goal of the new study is to see whether we can deepen and prolong initial responses by combining broad-kit inhibition from Kinloch with inhibition of the MAP kinase pathway using an MEK inhibitor. First-line imatinib has proven to be effective in stabilizing disease progression in most GIST patients, but less than 10% of patients experience complete regression. This often becomes imatinib resistant after acquiring secondary mutations, most often in kit, or the map kinase pathway can be reactivated, increasing kit expression.

Kinloss American Hamburger combination who's better than the Imatinib neck inhibitor combination and inhibiting sofa, even after removal of drugs.

One major advantage of using Qinghua, that's a combination partner with a second hit other over in that mood <unk> treatment did not results in the generation of resistance from mutations in preclinical studies.

We expect to initiate a phase won't be too who can legal study from the coming months to evaluate the safety that's gonna see in pharmacokinetics of Kinloch in combination with getting <unk> from patients witches.

Progressed on at least on that mood for hurting tolerant to amendment.

The study will pieces for the business collation, please and an expansion things.

But this escalation phase will follow the three plus three study design low.

Rotations with against just with nothing personally treated with Kinloch.

Matthew L. Sherman: These patients experience progressive disease that no longer responds to conventional treatment. Our Phase 1B2 clinical study is supported by exciting preclinical data that was recently published online in Molecular Cancer Therapeutics, as well as preclinical data presented at the EORTC, NCI, AACR meeting in 2018, showing that treatment with Kinloch, in combination with MEK inhibitors, effectively induced and enhanced apoptotic responses and prevented growth of resistant colonies in just cell lines In addition, Kinloch demonstrated superior efficacy to imatinib in combination with MEK inhibitors. The Kinloch MEK inhibitor combination was better than the Imatinib MEK inhibitor combination in inhibiting cell growth even after removal of the drugs.

The expansion phase of single coolest study to evaluate from <unk>.

Of the recommended please to just hope the combination with a co-worker patients who have progressed on for intolerance of single agent on that day.

We were focused on exploring the full potential of what we believe is can works best in class cute profile to benefit patients with just and believe that this combination therapy could give just patients from new treatment option that provides enhanced clinical benefit compared to kiss inhibition pulled up.

In addition to a clinical activities, where her security will on how robust publication presentation strategy.

There have been a number of recent publications highlighted businesses can log into just treatment landscape bill.

Building on the interpretation doses question day them presented last year from a phase one study is Kmart I'm pleased to announce the reporters present information just escalation data from the C. Three six or seven to them. He poster at the American Society is closed oncology per ask those annual meetings in June.

Matthew L. Sherman: One major advantage of using Kinloch as a combination partner with a MEK inhibitor over imatinib is that Kinloch treatment did not result in the generation of resistance mutations in preclinical studies. We expect to initiate a Phase 1B2 open-label study in the coming months to evaluate the safety, efficacy, and pharmacokinetics of Kimlox in combination with binning Matnib in patients with GIST who have progressed on at least Matnib or are intolerant to a Matnib. The study will consist of a dis-escalation phase and an expansion phase.

We are also making great progress and or other ongoing pipeline programs. Let me start with her best since we will be providing updated data from this program ask of this year.

The desk on it as a potential first in class selective inhibitor tied to countries.

We presented highly encourage you can play tumor activity for both the endometrial cancer. He unplugging resistant ovarian cancer cohorts from the phase one day to study in combination with Tucker Texel last year.

Matthew L. Sherman: The GIST escalation phase will follow a 3 plus 3 study design and will enroll patients with advanced GIST who have not been previously treated with KINLOCK. The expansion phase is a single cohort study to evaluate the efficacy and safety of the recommended phase 2 dose of the combination in a cohort of patients who have progressed on or are intolerant to single-agent implants. We are focused on exploring the full potential of what we believe is Kenloch's best-in-class KIT profile to benefit patients with JIS and believe that this combination therapy could give JIS patients a new treatment option that provides enhanced clinical benefit compared to KIT inhibition alone. In addition to our clinical activities, we are executing well on our robust publication presentation strategy. There have been a number of recent publications highlighting the use of Kinloch in the GIST treatment landscape.

Focusing on the endometrial cancer total work, we have completed or target enrollment of 33 patients in part to the study and we're excited to present updated data from the score but the upcoming <unk>.

We priestly reported and encouraging objected responds frightens heavily pretreated code work with a median of for part of the lines of treatment.

Further formula from now enable us to present progression free survival for these patients.

The regard to the training landscape range of neutral cancer or a limited options of the Paclitaxel and Carboplatin first mindset.

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Expected activity from penciled total retreated two little ones with a neutral cancer patients is a response rate from 10 to 20 per cent.

P F S as three to four months.

This was recently reinforced by the day the presented as a society doesn't can watch it on called your S. T O from T. Milk 77563 studies in patients with advanced endometrial cancer, who progressed after only one foreign regimen, which compared with that pay per Elizabeth to physicians choice of chemotherapy that'd be the week would test.

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Chemotherapy arm should confirm responds free 15%.

Matthew L. Sherman: Building on the intrapatient dose escalation data we presented last year from the Phase 1 study at Kenlark, I'm pleased to announce that we plan to present intrapatient dose escalation data from the Phase 3 Invictus study in an e-poster at the American Society of Clinical Oncology, or ASCO, annual meeting in June. We're also making great progress in our other ongoing pipeline programs. Let me start with Robasta Kni

<unk> 3.8 months, which is consistent with the rest mutations the limited activity of Sue agent Purple text will re treatment.

Neutral cancer.

In addition, we remain on transfers that up to the results from the ongoing saves one too.

Study the best combination would pass a text book an appointment resistant ovarian cancer cohort from the third quarter of the year.

We're focused on driving this program flow with them sufficiently as possible and we expect to finalize potential pivotal development plan forward to have submitted in combination with total taxes in the coming months.

Matthew L. Sherman: We will be providing updated data from this program at ASCO this year. Radacinib is our potential first-in-class selective inhibitor of the TIE2 kinase. We presented highly encouraging anti-tumor activity for both the endometrial cancer and platinum-resistant ovarian cancer cohorts from the Phase 1b2 study in combination with Paclitaxel last year. Focusing on the Endometrial Cancer Cohort, we have completed our target enrollment of 33 patients in Part 2 of the study, and we are excited to present updated data from this cohort at the upcoming ASCO annual meeting.

The other two programs without price mine's insult to the harbour potential best in class and picketers. Joseph one are from development for the treatment of tennis and you'll be on time so tumor.

M D. C. C 31, 16 on potential first and classic book on you some <unk> from development for the treatment of moving the rest rest Kansas remain on true.

First insulting of this year, we expect for zone updated day, though from ongoing stays one to study from patients with T. G. C. T from the third quarter and finalize the pivotal development plan for this program and the second half.

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31, 16, we're excited to initiate the person using study this quarter.

We look forward to the continued purpose of these programs you choose which has the potential to make a meaningful difference from the ones on patients fulfill current on the medical needs.

Matthew L. Sherman: We briefly reported an encouraging objective response rate in this heavily pre-treated cohort with a median of four prior lines of treatment, and further follow-up will now enable us to present progression-free survival for these patients. In regard to the treatment landscape for endometrial cancer, there are limited options after paclitaxel and carboplatin in the first line setting, and levatinib and pendrolizumab in the second line setting. The expected activity for paclitaxel retreatment in later lines of endometrial cancer patients is a response rate of 10 to 20% and a PFS of three to four months.

I will now from call us to talk on shelving Chief Financial Officer to review the financial results Tucker.

Thanks, Matt I'd like to be the highlights from our first quarter financial results total revenue for the first quarter was 25.2, <unk>, which includes 20 million in net Kotick revenue COVID-19.3 of which was from sales in the U S.

The gross Jeanette adjusted the first quarter was in line, whether annualize estimate approximately 15 per cent.

Collaboration revenue 5.2 million included a 5 million dollar development bastone under a license agreement zilog triggered by the regulatory approvals Kinloch in China in March.

One side begins to first of all I can look in greater China, we will receive royalties based on annual net sales levels that range from the low tie T.

Matthew L. Sherman: This was recently reinforced by the data presented at the Society of Gynecologic Oncology, or SGL, from Keynote 775, a Phase 3 study in patients with advanced endometrial cancer who progressed after only one prior regimen, which compared atatinib pembrolizumab to physicians' choice of chemotherapy of either taclotaxil or doxorubicin. The chemotherapy arms showed a confirmed response rate of 15% and a PFS of 3.8 months, which is consistent with our expectations of limited activity of single-aging peclotaxel retreatment in endometrial cancer.

In addition, we are eligible for up to 135 million in commercial milestones based on achievement of certain annual sales of Kinloch in greater China as well as additional development Boston.

Cost of sales for the three months ended March 31st 2021 was your material as the majority of the manufacturing costs related to Kinloss sales winford prior to F. D. A approval and thus will recorded as on do you expense.

As we have said previously we expect the cost of sales will remain the material to at least this year and would not expect cost of sales to be significant until the initial prelaunch inventories depleted an additional inventory is manufactured and sold.

Matthew L. Sherman: In addition, we remain on track to present updated results from the ongoing Phase 1-2 Study of Ribacinib in combination with papotaxel in the platinum-resistant ovarian cancer cohort in the third quarter of the year. We are focused on driving this program forward as efficiently as possible, and we expect to finalize a potential pivotal development plan for ribasamib in combination with peptotaxel in the coming months. The other two programs in our pipeline have been felt to knit together are a potential best-in-class inhibitor, CSF1R, in development for the treatment of tenosynovial gynosal tumors, and DCC3116, a potential first-in-class bulk kinase inhibitor, in development for the treatment of mutant RAS-RAF cancers, remain on track.

Total operating expenses from 86.4 million in the first quarter of 2021 compared to total operating expenses of $75.3 million in the same period in 2020.

Research and development expenses in the first quarter, where 55.7 million compared to 51.4 million in the same period, 2020, and selling general and administrative expenses in the first quarter over 30.7 million compared to 23.99 in the same period last year.

We continue to expect that are operating expenses will increase modestly this year as we invest in the development of our clinical pipeline execute on the commercial launch it kinloch in the U S and prepare for potential commercial launch in Europe.

We ended the first quarter on a strong financial position and remain well capitalized with cash cash equivalents and marketable securities of approximately 502, nine which you know expect will be sufficient to fund of operations into the first half of 2023.

Matthew L. Sherman: For Insultinib, this year, we expect to present updated data from the ongoing Phase 1 and 2 studies in patients with TGCT in the third quarter and finalize the pivotal development plan for this program in the second half. DCC 3116.

That I'll now trying to call back over to see.

Thanks Tucker from proud of the work our team is done on the first quarter of this year to sustain the momentum we built in 2020 as we continue to establish kinlaw because the standard of care for fourth one just we were excited to expand its range to patients and prescribers around the world with both the recent approval on China in our pending approval in Europe. Later this year as we realize the transformational potential.

Thomas Patrick Kelly: We are excited to initiate the first in-human study this quarter. We look forward to the continued progress of these programs, each of which has the potential to make a meaningful difference in the lives of patients and fulfill current unmet medical needs. I will now turn the call over to Tucker Kelly, our Chief Financial Officer, to review the financial results.

<unk> for patients with Fort mind, just we look forward to announcing topline results from entry in Q4 and unlocking the potential for can lock and the second 120 21 is also expected to bring significant updates across the balance of our pipeline, including the dosing of our first patient on the phase one study of decency 31, 16 as well as new.

Thomas Patrick Kelly: Thanks, Matt. I'd like to review the highlights from our first quarter financial results. Total revenue for the first quarter was $25.2 million, which included $20 million in net product revenue at Kinloch, $19.3 million of which was from sales in the U.S. The growth to net adjustment for the first quarter was in line with our annualized estimate of approximately 15%. Collaboration revenue of $5.2 million included a $5 million development milestone under our license agreement with Xilab, triggered by the regulatory approval of Kinloch in China in March. OneSide begins to commercialize Kinloch in Greater China.

Data and potential pivotal development plans for both of them Sultanate, Andrew <unk>.

Put that operator, I'd like to open the call for to you on it.

Thank you, ladies and gentlemen to ask the question you would need to press Star then one on your telephone.

[noise] to withdraw your question press the pound cake.

That next star one to ask the question.

Please stay on by well I'll be compiled the county roster.

Our first question comes from a line of Jessica five with J P. Morgan July on is open.

Hi, This is Daniel quite Jessica Thanks for taking a question. First question is you have stated in your prepared remarks that it will take time for data on duration of treatment to make sure with the product out in the market for almost a year. When do you expect to have better insight on the average time off on therapy and when you talk.

Thomas Patrick Kelly: We will receive royalties based on annual net sales levels that range from the low to the high teens. In addition, we are eligible for up to $135 million in commercial milestones based on achievement of certain annual sales of Kinloch in Greater China, as well as additional development. The cost of sales for the three months ended March 31, 2021, was immaterial as the majority of the manufacturing costs related to Kinloch sales were incurred prior to FDA approval and thus were recorded as R&D expenses.

About persistency similar to Invictus can you elaborate for us and provide some more detail.

Yeah, Daniel Thanks for the question. So it's like a set of questions day and would you like to take those.

Sure absolutely so with respect to uhm persistency looking similar to what we saw on and picked us when we map the persistence occur that's emerging for patients you receive can lock since launch it looks quite similar to the cap on Meyer care for.

Thomas Patrick Kelly: As we have said previously, we expect the cost of sales to remain immaterial through at least this year and would not expect the cost of sales to be significant until the initial pre-launch inventory is depleted and additional inventory is manufactured and sold. Total operating expenses were $86.4 million in the first quarter of 2021 compared to total operating expenses of $75.3 million in the same period in 2020. Research and Development Expenses in the first quarter were $55.7 million compared to $51.4 million in the same period last year. And Selling, General, and Administrative Expenses in the first quarter were $30.7 million compared to $23.9 million in the same period last year.

PFS from Invictus, So what we think that day sort of a good guide for kind of what we're seeing in the persistency day to thus far.

And then the the comment about it it'll take time to develop that was more about the average as opposed to sort of per cent of pay per cent of patients on therapy at different time points. On these early days. So the average of course won't be impacted by a potential out long tail long long responders.

And the persistence current and given that we're only as you say about a year and to launch give or take we're just not there yet you know if you think about the clinical data from phase one on trial. For example, it took you know multiple years to sort of fully developed those are on responder. So that was why I said you know if we look at the data.

Steven L. Hoerter: We continue to expect that our operating expenses will increase modestly this year as we invest in the development of our clinical pipeline, execute on the commercial launch of Kinloch in the U.S., and prepare for a potential commercial launch in Europe. We ended the first quarter in a strong financial position and remained well capitalized with cash, cash equivalents, and marketable securities of approximately $500 million. What you now expect will be sufficient to fund our operations into the first half of 2023. And with that, I'll now turn the call back over to Steve. Thanks, Tucker.

From clinical trial today, we would expect the average to be somewhat longer than the median but it'll just take us some time for that day to to mature.

Got it and then Uhm I know that you have said the next lake of meaningful grudge will come from sales and second line, but should think about this roughly 20 million quarterly run it and to go on that's a good run right to use going forward for a day you at sports <unk> opportunity or is that on potential for that to change that's the impact of COVID-19.

Lessons going forward.

Steven L. Hoerter: I'm proud of the work our team has done in the first quarter of this year to sustain the momentum we built in 2020. As we continue to establish Kenlock as the standard of care for fourth-line GIST, we are excited to expand its reach to patients and prescribers around the world with both the recent approval in China and our pending approval in Europe later this year. As we realize the transformational potential Kenlock has for patients with fourth-line GIST, we look forward to announcing top-line results from Intrigue in Q4 and unlocking the potential for Kenlock in the second quarter.

And you'll see if it's a it's a good question I think as Dan mentioned in his prepared remarks, we do see day that both in claims as well as from third party providers that suggests that there has been and is an ongoing impact from from the pandemic and I think it's just inherently uncertain as to how that's on false for us with Ken locked during the course of this year.

I'm Gonna stay on mentioned you know our view is that we'll see limited growth as a result of the contacts uhm here going forward as we get to the read out of intrigue on the second line and potential approval that would come subsequent to that.

Okay and last one the P. R states that the cost of sales will not be significant until initial prelaunch inventories depleted an additional inventories manufactured installed do you have an estimate on when you buy stuff that England true.

Steven L. Hoerter: 2021 is also expected to bring significant updates across the balance of our pipeline, including the dosing of our first patient and the phase one study of GCC 3116, as well as new data and potential pivotal development plans for both encelfinib and ribacinib. With that, Operator, I'd like to open the call for Q&A. Thank you. Ladies and gentlemen, to ask a question, you will need to press star and then one on your telephone. To withdraw your question, press the pound key.

So shall we don't I just talked on other than that we we don't expect it to be material. This year and that as we move forward, we'll be able to provide updated guidance on on what the cause might look like in terms of what will be.

Selling inventories it was not capitalize the time on approval.

Great again, thank you very much for taking my question.

Thank you.

Our next question comes from Atlanta, Chris Raymond with Pakistan Atlantis, Okay.

Hey, Thanks for taking the questions just to help me understand the math a little bit I I think I heard you guys say that there's more than 400 prescribers this quarter and I and I think by by my math, that's about a 15 per cent prescriber growth quarter on quarter.

Unknown Executive: Again, that's star number one to ask the question. Please stand by while we compile the Q&A roster. Our first question comes from the line of Jessica Fye with J.P. Morgan. Your line is open. Hi, this is Daniel for Jessica.

And I remember the last quarter, you guys mentioned that the percentage of docs. It had multiple patients on therapy would go pretty low.

And I think I hear what you're saying with respect of COVID-19, but maybe just if you can maybe first of all just square that if if you've got a 15 per cent prescriber growth how does that square with you know with with flat quarter to quarter revenue and maybe can you talk about any sort of dynamics with respect to like uhm free drug.

Daniel L. Flynn: Thanks for taking our questions. The first question is: you have stated in your prepared remark that it will take time for data on duration of treatment to mature. With the product now in the market for almost a year, when do you expect to have better insight on the average time on therapy? And when you talk about persistency, similar to Invictus, can you elaborate for us and provide some more detail? Yeah, Daniel, thanks for the question. It's a good set of questions. Dan, would you like to take these?

Or anything like that that might be also impacting the revenue number of things.

Yeah. Thanks for the set of questions Chris stand would you like to take those.

Yeah, absolutely. Thanks, Thanks for the question, Chris Yeah. So the key insight here that keeping to keep in mind is that uhm not all prescribers contribute patience. Each corner. This is a rare you know cancer on the fourth one setting and so we can see new prescribe a growth since launch but.

Daniel C. Martin: Sure, absolutely. So, with respect to persistency looking similar to what we saw in Invictus, when we map the persistency curve that's emerging for patients who've received Kinloch since launch, it looks quite similar to the Kaplan-Meier curve for PFS from Invictus. So, we think that's a sort of a good guide for kind of what we're seeing in the persistency data thus far. And then, the comment about it will take time to develop, which was more about the average as opposed to sort of percent of patients on therapy at different time points in these early days.

That doesn't mean that every one of those prescribers and therefore every one that's contributing to that 50 per cent growth. You mentioned is contributing patients on any given corner. We've said previously that especially once you get on the community setting you know cause. This is may only see for fine just patient.

Every 12 to 18 months. So it's just it's really <unk> and that's really the driver I think hopefully that helps squared the math a little bit for Ya.

Daniel C. Martin: So, the average, of course, will be impacted by a potential long tail and the Persistency Curve. And given that we're only, as you say, about a year into launch, give or take, we're just not there yet. You know, if you think about the clinical data from phase one trials, for example, it took, you know, multiple years to sort of fully develop those long responders. So that was why I said, you know, if we look at the data from clinical trials today, we would expect the average to be somewhat longer than the median, but it'll just take us some time for that data to mature.

Well, yeah. It does but I guess you know just the inference that the fourth line just market opportunity is $80 million I guess that you know.

Seems to also sort of.

Raised some questions like I said I'm getting from some investors how was it.

That size, if we lower I think then then the the patient numbers that we've gotten and I know you mentioned COVID-19, but.

If you have any current sort of sense of patient started getting treated what what.

What what is what is happening with these folks sorry for the.

Kind of dumb question, there, but yeah.

Daniel C. Martin: And then I know that you have said the next leg of meaningful growth will come from SELF and Second Line, but should we think about this roughly 20 million quarterly run in the U.S. as a good run rate to use going forward for the U.S. sport line opportunity, or is there a potential for that to change as the impact of COVID lessens going forward? Yeah, Daniel, and Steve, it's a good question. And I think, as Dan mentioned in his prepared remarks, we do see data, both in claims as well as from third-party providers that suggest that there has been and is an ongoing impact from the pandemic.

No. It's a it's a good question so I think a couple of.

Important things to keep in mind.

<unk> sure previously that you know, it's it's important to us support can recognize on when you use a persistency curve.

Uhm that really reflects the amount of patience on therapy at any given time point and when you use an average.

Number you plug that average isn't it tends to overestimate the number of active patience in the early days of launch. So I don't know if that is you know a delta and how you've built your model, but what I can say is that given all of the day that you know we share previously and this call in a prior calls.

Steven L. Hoerter: And I think it's just inherently uncertain as to how that unfolds for us with Kenlock during the course of this year. You know, as Dan mentioned, our view is that we'll see limited growth as a result of the context here going forward as we get to the readout of intrigue in the second line and potential approval that would come subsequent to that. And lastly, the PR states that the cost of sales will not be significant until the initial pre-launch inventory is depleted, and additional inventory is manufactured and sold.

I think we've got a great job rapidly penetrating the opportunity.

The response from the physician spoke academic and community has been overwhelmingly positive and go ahead and get set up great for the larger opportunity and second line pending approval.

Okay. Thank you.

Thank you.

Your next question comes from the land E on yeah.

Inc, but jeffries fell on his.

Okay.

Steven L. Hoerter: Do you have an estimate of when you'll exhaust that inventory? So we don't, other than that we don't expect it to be material this year and that as we move forward, we'll be able to provide updated guidance on what the COGS might look like in terms of what will be selling inventory that was not capitalized at the time of.

Thank you so uhm laziest honey and trained to study patient on your room until like a complaint. It at the end of November last share. So I'm Gonna ask you a couple of questions. There one.

I just yeah, I'll use too comfortable with who you are P. F. S assumption from you can move it around six months and a second question is.

Unknown Executive: Again, thank you very much for taking my questions. Our next question comes from the line of Chris Raymond with Piper Sandler. Your line is open.

Ask you E P.

<unk> I haven't been occurring in line with your expectations.

Christopher Joseph Raymond: Hey, thanks for taking the questions. Just help me understand the math a little bit. I think I heard you guys say that there are more than 400 prescribers this quarter. And I think, by my math, that's about 15% prescriber growth quarter on quarter. And I remember last quarter you guys mentioned that the percentage of docs that had multiple patients on therapy was still pretty low. And I think I hear what you're saying with respect to COVID, but maybe just if you can, maybe first of all, just square that.

Yeah, I tell you on a C. So I'll I'll be happy to take those questions. So I think with respect to the first question about what we'd expect to see from suits that I've thought of you with that hasn't changed has been talked about on prior calls we would expect based on the pivotal study for suits and and what they're <unk>, which is on the switch on label that a PFS of 546 months.

Uhm, we would expect to see a PFS in present day, the present day environment of something on the range of six months and that's very consistent with the feedback that referred but historically and also to this day from from Salt Lakers. So we're very comfortable with what we'd expect to see from switch on it as you know from our phase one experience in our second line cohort from the phase one we've seen really compelling data.

Christopher Joseph Raymond: If you've got a 15% prescriber growth, how does that square with, um, you know, with flat quarter-to-quarter revenue? And maybe you can talk about any sort of dynamics with respect to free drugs or anything like that that might be also impacting revenue.

<unk> in that cohort with a medium TFS of 10.7 months and of course, you know invictus. So we think the totality of the day to me political day to regenerate. It so far with can lock Uhm is is is very positive and and confidence on the potential furniture and give you a positive study remains unchanged uhm in terms of.

Daniel C. Martin: Yeah, thanks for the set of questions, Chris. Dan, would you like to take those? Yeah, absolutely. Thanks.

<unk> of events, we haven't commented in terms of what the the pace of events, we would expect to be I would just note that when we we first design. The study on loaded the information on clinical trials Dot Gov. We had expected at that time that that we would get to the primary endpoint of the study in June of this year and of course, the number of things have changed.

Daniel C. Martin: Yeah, so the key insight here, the key thing to keep in mind, is that not all prescribers contribute patients each quarter. This is a rare cancer in the fourth line setting. And so we can see new prescriber growth since launch, but that doesn't mean that every one of those prescribers, and therefore every one that's contributing to that 15% growth you mentioned, is contributing patients in any given quarter. We've said previously that, especially once you get out in the community setting, physicians may only see a fourth-line GIST patient every 12 to 18 months. So it's just, it's really rare, and that's really the driver, I think. Hopefully, that helps square the math a little bit for you. Well, it's...

Along the way in terms of number of subjects on the study and also you know the environment in which we're operating but we don't view the refinement of our guidance on queue for in terms of the top line read out as being Beverly a substantive sort of change.

Thank you and then a question on the opinion that made the combo study. So as you mentioned a second line how are you.

Alrighty can cost they live on that's a perfect so by adding Penny, Matt Knabe close to madness.

You know considering.

Unknown Executive: Well, yeah, it does. But I guess, you know, just the inference that the fourth line gross market opportunity is $80 million. I guess that, you know, seems to also sort of... Raise some questions that I guess I'm getting from some investors, how is it that you get a sizably lower number than the patient numbers that we've gotten. And you mentioned COVID, but if you have any sort of sense of whether patients are getting treated, what is it, what is it, what is it happening with these folks? I'm sorry for the... Kind of a dumb question there, but yeah.

I like <unk> can share potentially increase the side effects on what are what are you aiming to cheap.

Thank you too thanks for your <unk>, it's Steve I'll I'll take that and then May I. Please feel free to chime in as well. They were really excited about the day to that we've generated that now isn't that set in his prepared remarks has has been published showing the real synergy between Ken lock and <unk> generally so our goal given the fact that.

Can lock is now established as mono therapy as the standard of care on the fourth one uhm, we hope and expect that will certainly be the case went intrigued resolved in Q4 of this year or did you move to it against the drug as monotherapy into an earlier line of treatment based on a tree, but our goal on this disease with can lock is really to maximize the potential clinical benefit for patients.

Unknown Executive: No, it's a good question. So I think there are a couple important things to keep in mind. We've shared previously that, you know, it's important to use, and it's important to recognize that when you use a persistency curve, that really reflects the amount of patients on therapy at any given time point. And when you use an average number, you plug that average in, that tends to overestimate the number of active patients in the early days of launch.

We think based on the preclinical day to regenerated. If we followed that science that there is a real potential for us to potentially uhm deepened and prolong responses that we see with the combination relative to monitor therapy can lock and we certainly have some indication of the potential for that based on on day to that's that's already been Jenner.

Unknown Executive: So I don't know if that is, you know, a delta in how you've built your model, but what I can say is that given all of the data that we've shared previously on this call and in prior calls, we think we've done a great job rapidly penetrating the opportunity. The response from physicians, both academic and community, has been overwhelmingly positive, and I think it sets up great for the larger opportunity in second-line pending approval. Thank you. Our next question comes from the line of Eun Yang with Jeffries. The line is open.

But the Mad at anything else, you would add to that commentary in terms of the potential for them that combination.

Yeah no. Thanks, you for the questions here and also just ahead and we feel very excited about the combination your combination therapy in oncology tends to be a very good way of increasing responses and increasing the durability from those responses and based on the pre coupal date of that that would be quite later today and that's available uhm, we feel that the <unk> pretty much.

Eun Kyung Yang: Thank you. So, the Phase III Intrigue Study patient enrollment was completed at the end of November last year. So, I want to ask you a couple of questions there. One, I just want to ask you if you are still comfortable with your PFS assumption for sunitinib at around six months? And the second question is, I want to ask you if PFS events have been in line with your expectations. Hi Eunice, Steve.

We'll make a do some supports the combination of the <unk> <unk>.

Uhm.

Can work in terms of safety.

We send me another kinloch is a very good safety profile based on what's on the label as well as what we've heard from investigators and we'll be starting know forgive me with this escalation studying cover the issue with getting that <unk> can feel that and there will be able to monitor and manage any if this happens with may occur.

So question, it's almost specifically what additional P. F F. A benefactor did a meaningful.

Steven L. Hoerter: So I'd be happy to take those questions. So with respect to the first question about what we'd expect to see from SUTINT, our view of that hasn't changed. As we've talked about on prior calls, we would expect based on the pivotal study for SUTINT and what they're in, which is in the SUTINT label, that a PFS of 5.6 months would expect to see a PFS in present day, in the present day environment, of something in the range of six months. And that's very consistent with the feedback that we've heard historically and also to this day from thought leaders.

Please show on that cost 11 months to pay a price to leave town riprap neighbour law on the second line.

Yeah, Yeah, and I think that they put simply we we think there may be an opportunity to continue to raise the bar. So we're certainly not satisfied with the with 10.7 months.

And we'll see the day to some intrigue amount of therapy coming up here in Q4, but to the extent there was an opportunity isn't that outlined through a combination of first with Ken lock is really the backbone of that combination to drive better PFS on a longer response for patients. That's certainly something that we're interested in for sure.

Steven L. Hoerter: So we're very comfortable with what we'd expect to see from SUTINT. And as you know, from our phase one experience in our second line cohort from phase one, we've seen really compelling data in that cohort with a median PFS of 10.7 months. And, of course, you know, INVICTUS.

Thank you.

Thank you.

Next question comes from the line of Michael Schmidt, We Guggenheim Your line is okay.

Hi, guys. Thanks for taking my questions I had a few more on the entry study interest on the refined guidance for data on now on the fourth quarter I guess it has to be on a change in the event rate relative to your initial expectations or perhaps the censoring right.

Steven L. Hoerter: So we think the totality of the data, I mean, clinical data we've generated so far with Kenlock is very positive, and our confidence and the potential for intrigue to be a positive study remain unchanged. In terms of the accumulation of events, we haven't commented in terms of what the pace of events we would expect to be. I would just note that when we first designed the study and loaded the information into clinicaltrials.gov, we had expected at that time that we would get to the primary endpoint of the study in June of this year.

Yeah, Michael let's see thanks for the question you know we haven't disclosed as you know the event right. When we expect the events too you know to to fully accrue uhm and the timing for that but I you know as I said earlier in response to an earlier question the refinement to queue for certainly within the range of what we do.

Steven L. Hoerter: You know, of course, a number of things have changed along the way in terms of the number of subjects in the study and also, you know, the environment in which we're operating. But we don't view the refinement of our guidance to Q4 in terms of the top line readout as being really a substantive sort of change.

Got it you previously this was the second half. So we're just now in a position where we can narrow that down a little bit better which was the reason that we made the incremental disclosure today.

Perfect. Thanks, and then a question we've been getting from investors around you know how <unk> and can perform different me depending on the type of kept mutations I think specific pay next on throw it can causing mutations askington has asking sean to to perform relatively well I guess.

Unknown Executive: And then a question on the BinimedNib combo study. So, as you mentioned, in the second line, you are already seeing close delivery of PFS. So, by adding BinimedNib, post-MedNib, considering, you know, likely potential, potentially increased side effects, what are you aiming to achieve? Thank you. Yeah, thanks, Eun. It's Steve.

Could you remind us how to prep net performs an X on 13 14, Texas specific please what I can assist you with and perhaps what percentage of second mine just patients have exclusively S on back and forth invitation.

Steven L. Hoerter: I'll take that, And then, Matt, please feel free to chime in as well. I mean, we're really excited about the data that we've generated that, now, as Matt said in his prepared remarks, has been published, showing the real synergy between Kenlock and MEK inhibitors generally. So our goal, given the fact that Kenlock is now established as monotherapy as the standard of care on the fourth line, we hope and expect that will certainly be the case when Intrigue reads out in Q4 of this year and as we move to advance the drug as monotherapy into an earlier line of treatment based on Intrigue.

Yeah. Thanks for the question on Michael So I'll start off and then I'll turn it over to Matt I mean, I think as you know as we've talked about previously when we design. This drug uhm specifically for just the goal was to design a broad spectrum inhibitor and we think we've now very convincingly demonstrated that can lock is in fact, a broad spectrum inhibitor based on the strength of the data from from Invictus and also.

The date of the other generated in the phase one and we're looking forward of course to the the report other than tree care later this year, but <unk>, what what additional color commentary would you also in terms of nutritional background on the second one.

Steven L. Hoerter: But our goal in this disease with Kenlock is really to maximize the potential clinical benefit for patients. And we think, based on the preclinical data we've generated, if we follow that science, that there is a real potential for us to potentially deepen and prolong responses that we see with the combination relative to monotherapy Kenlock. And we certainly have some indication of the potential for that based on data that's already been generated. But Matt, anything else you would add to that commentary in terms of the potential for the MEK combination? Yeah, no, thanks, Eun, for the questions here.

Yeah, I think we could also just point to the very strong results be in Victor study and force mind patients had really those the patience with primary characterized by the most who would you maybe so they're mutational the burden and that's what we should and a presentation last year and yet despite that broadhead, you're moving of uhm.

<unk> and the first one just patient population, we had the outstanding results of the payment for the PFS as well as.

Clinical meaningful increases over on survival. So we can just the reinforcing the blood activity reported against the Muslim kept the mutations.

Matthew L. Sherman: And also, just to add, I mean, we feel very excited about the combination. Combination therapy and oncology tend to be a very effective way of increasing responses and increasing the durability of those responses. And based on the preclinical data that we highlighted today and that is available, we feel that the biological mechanism supports the combination of an MEK inhibitor with Kinloch. In terms of safety, you know, we certainly know that Kinloch has a very, you know, good safety profile, based on what's in the label as well as what we've heard from investigators.

Okay, Thanks, and interest on the <unk> combination strategy. If that's something that is you know to be pursued strictly in the post imatinib setting is that a combination that could perhaps take on <unk> first can I just on the road.

Yeah. Michael is a good question I think you know Matt can touch on this as well, but you know as he noted in his prepared remarks uhm, we've seen in in a preclinical setting you know the potential for the combination of Mac with Ken lock to be superior to that isn't that net plus I can help it or so you know because you can lock of course is I'd say.

Steven L. Hoerter: And we'll be starting off by dealing with the fusculation study in combination with getting that in, and feel that, you know, we'll be able to monitor and manage any adverse events that may occur. The question is more specifically what additional PFS benefits would be meaningful if you showed about close to 11 months of PFS with reproductive loan on the second line. Yeah, you know, I think, put simply, we think there may be an opportunity to continue to raise the bar.

A much better job on a mountain it brought it to preventing additional mutations and kit from emerging. So we do think that that combination has potential our initial step of course with this study is to generate the date on once we get two doses of the two drugs that can be combined but then get generating data and the second line and will of course have a very contemporary Aeneas <unk>.

Steven L. Hoerter: So we're certainly not satisfied with 10.7 months, you know, and we'll see the data from Intrigue as monotherapy coming up here in Q4. But to the extent there's an opportunity, as Matt outlined, through a combination approach with Kenlock is really the backbone of that combination to drive better PFS and a longer response for patients. That's certainly something that we're interested in pursuing. Thank you. Thank you. Our next question comes from the line of Michael Schmidt with Guggenheim. Your line is open.

Parison with the intrigued day does that report that later this year as monotherapy really to understand what the incremental benefit maybe of adding that can help it or to kinloss in that setting.

Great. Thank you.

Thank you on next question comes from the line and ran Benjamin JMP Security. Your line is okay.

Hey, good afternoon, guys. Thanks for taking the questions and congrats from a quarter, maybe just focusing on the China approval can you provide any sort of color as to how we should be thinking about the launch or you know how so I lapses preparing for the launch how big their sales force could be I guess I'm, just trying to get an idea as to.

Michael Werner Schmidt: Hey guys, thanks for taking my questions. I had a few more on the intrigue study, just on the refined guidance for data now in the fourth quarter. I guess, has there been a change in the event rate relative to your initial expectations or perhaps the censoring rate? Yeah, Michael, it's Steve.

How we should be thinking about the trajectory is it more kind of like how things are going here in the U S. As what you would expect there or should we be thinking more along how things are going in the rest of the world or some mix of the two and maybe just an accounting one for Tucker's Tucker do we expect the royalty revenues to come in in the second quarter.

Steven L. Hoerter: Thanks for the question. We haven't disclosed, as you know, the event rate or when we expect the events to fully accrue and the timing for that. But I, you know, as I said earlier, in response to an earlier question, the refinement to Q4 is certainly within the range of what we guided you previously, which was the second half. So we're just now in a position where we can narrow that down a little bit better, which is the reason that we made the incremental disclosure today. Perfect, thanks.

This year is there a one quarter delay thanks.

<unk>.

Yeah ready to see so I'll I'll take the first part of that and then turn it over to Tucker. So we know it's design lab has disclose with respect to just in China, which is that there are 30000, new patients each year in China with just so it's of course, a sizeable population in sizeable opportunity I think when it comes to a drug like Kinloch, which <unk>.

Michael Werner Schmidt: And then a question we've been getting from investors around, you know, how Zutin can perform differently depending on the type of kit mutations. I think specifically in Exxon 1340 mutations, Zutin has been shown to perform relatively well. I guess, could you remind us how RepredNet performs in Exxon 1340 mutations specifically, relative to Zutin, and perhaps what percent of second-line just patients have exclusively Exxon 1340 mutations? Yeah, thanks for the question, Michael. So I'll start off, and then I'll turn it over to Matt.

<unk> plans to launch here later than quarter to <unk> I think the launch trajectory on ultimate opportunity really depends upon the ability of <unk> to access the full opportunity and for the patients with just in China broadly speaking to have access to a motivated medicine I know that's something that good size with a focus on on me having provided any additional.

Color or refinement in terms of what to expect in terms of ramp of can lock it with the trying to watch.

And when it's Tucker just to take the second part of your question, we would expect when they make a sale on their end and and have for patients be prescribed can liked it. We would then recognize the royalty revenue I think so I hasn't yet guy to do exactly when they expect to be in market with the drug. So we just have to wait and see from there.

Steven L. Hoerter: I mean, I think, as you know, as we've talked about previously, when we designed this drug specifically for GIST, the goal was to design a broad-spectrum inhibitor. And we think we've now very convincingly demonstrated that Kinloch is, in fact, a broad-spectrum inhibitor based on the strength of the data from Invictus and also the data that we generated in Phase 1. And we're looking forward, of course, to the report from Intrigue here later this year.

Specific to their lunchtime, but otherwise you would expect it to be when they're making sales on there.

Got it and then maybe just as a quick follow up I saw the two rabassa <unk> update one on the second quarter. It <unk>. Another one in the third M. I am I missing. The Carboplatin study is are we expecting an update from that at some point.

Matthew L. Sherman: Matt, what additional color commentary would you offer in terms of the mutational background for the second line? I think we could also just point to the very strong results of the INVICTA study in fourth-line patients. And really, those are the patients who are probably characterized by the most heterogeneity of their mutational burden, and that's what we showed in the presentation last year. And yet, despite that broad heterogeneity of mutations in the fourth line just patient population, we had outstanding results of the benefit of PFS, as well as a clinically meaningful increase in overall survival.

Yeah. Thanks for the question right, what do you want to check that in terms of the day to flow coming from the road asking a pleasure.

Yeah. So is uhm, yeah sure I like to appear we're <unk>. We're continuing you know with a combination of her best it in combination with the Paclitaxel with the highlights this year for both the endometrial cancer cover in the appointment Justin ovarian cancer cohort, but we also have a combination study income an issue with her.

Matthew L. Sherman: So again, just reinforcing the broad activity of reprinting it against multiple kit mutations. Okay, thanks. And then just on the binimatinib combination strategy, is that something that is, you know, to be pursued strictly in the post-imatinib setting, or is that a combination that could perhaps take on imatinib and first-line gist down the road? Yeah, Michael, it's a good question. And I think, you know, Matt can touch on this as well. But, you know, as he noted in his prepared remarks, we've seen in a preclinical setting the potential for the combination of MEK with Kenlock to be superior to that of a MATINIT plus an MEK inhibitor.

Platinum and that's currently being studied and patience with uhm appointment sensitive but for instance that we haven't provided an update yet Mr. When will be the updating from those data.

Okay I just wanted to make sure. It was it was continue to move on it thanks very much guys.

Thank you.

As a reminder, ladies and gentlemen that star one to ask the question.

Our next question from from the lineup Peter Lawson with Barclays. Your line is open.

Great. Thanks for the for the update on the cash runway Tucker that was extended was there a reason why.

Yeah check on it looks you may be on mute Tucker.

<unk> Yep, sorry, Peter It's Tucker absolutely every quarter, we look at our operating expenses Uhm and historical and update our forecast going forward. So no. There there really wasn't a significant change by any means it's in in our assumptions underlying it we just have a little bit more history to look at and and better abilities trying to forecast the cash one way.

Matthew L. Sherman: So, you know, because Kenlock, of course, does a much better job than MATINIT would at preventing additional mutations in kit from emerging. So we do think that that combination has potential. Our initial step, of course, with this study, is to generate data once we get to doses of the two drugs that can be combined, but then generating data in the second line. And we'll, of course, have a very contemporaneous comparison with the intrigue data that reports out later this year as monotherapy, really to understand what the incremental benefit may be of adding MEK inhibitor to Kenlock in that setting. Great, thank you. Thank you. Our next question comes from the line of Ren Benjamin of JMP Security. Hey, good afternoon, guys.

And in this case, we're able to push it out into the first half of 2023.

Thank you and then just on the I guess the real world settings can look just the deterioration of treatment and you'll see.

Or anything you can <unk>.

<unk>.

Yeah, Thanks, Peter Day, and do you want to comment on that.

Sure Uhm <unk> is it.

So Peter I, just want to make sure I I answer your your question in my prepared remarks, I just laid out that we are starting to see that persistent to cover emerge in it and it's looking.

Reni John Benjamin: Thanks for taking the questions and congratulations on the quarter. Maybe just focusing on the China approval, can you provide any sort of color as to how we should be thinking about the launch or, you know, how Scilabs is preparing for the launch, and how big their sales force could be? And I guess I'm just trying to get an idea as to how we should be thinking about the trajectory. Is it more like how things are going here in the U.S. are what you would expect there, or should we be thinking more along how things are going in the rest of the world?

Similar to the K M curve for PFS from Invictus was there something specific that I could provide more color on yeah.

I guess I, probably addresses day. It was just kind of trying to work out if it was.

Longer or shorter than what you've seen in the trial, but it it sounds like it's similar.

Mmm, yes.

Steven L. Hoerter: https://www.youtube.com Thanks.

Gotcha, and then you know and and just said no sorry, Peter and just to note right. You. We always get asked about average vs. Median it's just too early to know about whether the average will be longer than the median we would we would expect it to be somewhat longer based on data that we've seen in.

Thomas Patrick Kelly: Yeah, Ren, it's Steve. So I'll take the first part of that and then turn it over to Tucker. So, you know, we know what Xi Lab has disclosed with respect to JIFS in China, which is that there are 30,000 new patients each year in China with JIFS. So it's, of course, a sizable population and a sizable opportunity. I think when it comes to a drug like Kinloch, which, you know, Xi, as they've guided to, plans to launch here later in quarter two, I think the launch trajectory and ultimate opportunity really depend upon the ability of Xi to access, you know, the full opportunity and for the patients with JIFS in China, broadly speaking, to have access to an innovative medicine.

Clinical trials, but that's something that will continue to let the day to make sure to help inform.

Thank you and then just I guess another question around the the MC inhibited so it sounds like it.

<unk> <unk>.

Just your ability, but it I mean is there any chance that day and says over a response rate or that's sounds like that's rule it out.

Thank you.

Our next question comes from them on a Robyn Canuck what choice security Your line is open.

Thomas Patrick Kelly: I know that's something that Xi is really focused on, but they haven't provided any additional color or refinement in terms of what to expect in terms of the ramp-up of Kinloch with the Chinese law. And Ren, it's Tucker. Just to take the second part of your question, we would expect when they make a sale on their end and have patients being prescribed Kinloch, that we would then recognize the royalty revenue. I think Xi hasn't yet guided exactly when they expect to be in the market with the drug. So we just have to wait and see the specifics of their launch timing. But otherwise, we would expect it to be when they start making sales on that. I got it.

Hey, guys. This is hold on for Robyn.

Yes. Please go ahead.

Oh. Thank you so much for taking my question.

So barring the impact of COVID-19 per can lock do you see any additional lever to enhance uptake in force line.

What kind of feedback have you been getting from doctors, especially around safety and this is in relation honestly do the second line program that's ongoing.

Can you remind us about safety concerns mm around sutent and if you're hearing anything about down dosing regimen, that's used and did you get on what setting.

Reni John Benjamin: And then maybe just as a quick follow-up, I saw the two ribacinib updates at ASCO, one in the second quarter and another in the third. Am I missing the carboplatin study? Are we expecting an update on that at some point? Yeah, thanks for the question, Ren. Matt, do you want to take that in terms of data flow coming from the Rabacinet program? Yeah, so as you know, as you highlight, we're going to, we're continuing, you know, with the combination of herbacidin in combination with paclitaxel with the highlights this year for both the endometrial cancer cohort and the platinum-resistant ovarian cancer cohort. But we also have a combination study in combination with carboplatinin, and that's currently being studied in patients with platinin-sensitive ovarian cancer.

Yeah, I grew up with Steve So I'll I'll take that question and and Peter if you're still listening will come back to your question I think we were having a mute issue, but I'm gonna come back to the question that you asked as well so with respect to search engine, how it's used in real world settings, Yes, I mean, <unk>, they're very consistent feedback from here from investigators in from physicians, who.

To use this drug is that it is common for the the the drive to the dose reduced as a result of Tolerability challenges. So that is something that'd be understand is a fairly common occurrence.

And are you getting any type of feedback around cannot say.

<unk> that you'd think he'd get friends from like it sent sought in your day.

Clinical setting.

We we hear on with respect to cannot very consistent feedback that's consistent with with our our label and the clinical experience and get the drug as well tolerated uhm and and there.

Matthew L. Sherman: We haven't provided an update yet. This is when we'll be updating the data. Okay, I just wanted to make sure it was continuing to move forward. Thanks very much, guys. Thank you. As a reminder, ladies and gentlemen, that's star number one to ask the question. Our next question comes from the line of Peter Lawson with Barclays. Your line is open.

Yeah, I think physicians do it that way, especially relative to other options that are available to them and to their patients. So with just so I think the drugs that you just being a well tolerated effective option for patients.

Peter Richard Lawson: Great. Thanks for the update. Just on the cash runway, Tucker, that was extended out. Was there a reason why?

Alright, and one more question Alright. Thank me for the day to read out from the faith to Thailand for quite a what can you tell us about what do we do.

Unknown Executive: That was extended out. Was there a reason why?

Thomas Patrick Kelly: Yeah, Tucker, it looks like you may be on mute, Tucker. Oh, apologies. Yep. Sorry, Peter. It's Tucker.

Do we see topline day that whether it's <unk> met the appoint or not.

Are more detail than that or should we expect more detailed presentation <unk> medical conference maker.

Thomas Patrick Kelly: Absolutely. Every quarter, we look at our operating expenses and historical data and update our forecast going forward. So, no, there really wasn't a significant change by any means in our assumptions underlying it. We just have a little bit more history to look at and a better ability to try and forecast the cash runway. And in this case, we're able to push it out into the first half of 2020.

Like just the top line.

I think it's fair to expect that we'll have a relatively fulsome, yeah topline readout similar to what we did for the Invictus study when we reported out those data. So we will seek to provide relevant information on the on the primary endpoint at the study a new as well as the teller ability profile of the drug based on the experience in the interest study.

Peter Richard Lawson: And then just on the, I guess, the real world setting for Kinloch, just the duration of treatment you're seeing. It's the same thing. Yeah, thanks, Peter. Dan, do you want to comment on this? Sure. So Peter, I just want to make sure I answer your question. In my prepared remarks, I just laid out that we are starting to see that persistency curve emerge and it's looking, similar to the KM curve for PFS from Invictus. Was there something specific that I could provide more color on? Yeah, I guess that probably addresses it. I was just kind of trying to work out if it was...

Okay, great. Thank you so much.

Great. Thanks, and then I just wanted to come back to your to your question that you asked <unk> with respect to the Mexican Hebeler combination and whether we might expect to see more to herself, killing or more of a set aside all response with that combination vs side simply prolongation of those thoughts on that I wanted to ask if you would like to.

Address that based on the preclinical data that we've generated and what's been published on now on long just today.

Daniel C. Martin: Longer or shorter than what you've seen in the trial, but it sounds like it's similar.

Sure Yeah, no. Thanks, very important to recognize that there was a pilot study that was done let me spell that for you I just wanted to study at Memorial Sloan Kettering, but there was presented and ask her last year was a combination of the matinee within the net minutes. So based on the same preclinical rationale that we've discussed today. The it was I figured the day it was able to show that was.

Unknown Executive: And just to note, sorry Peter, and just to note, right, we always get asked about average versus median. It's just too early to know about whether the average will be longer than the median. We would expect it to be somewhat longer based on data that we've seen in clinical trials, but that's something that we'll continue to let the data mature to help inform.

Covered both 40 patients from objected responds free of 60 per cent that compares very favorably circle activity of about 50 per cent for single agent on that the progression free survival from that combination.

Peter Richard Lawson: Gotcha, thank you. And then just, I guess, another question about the MEK inhibitor.

Unknown Executive: It sounds like it enhances durability, but is there any chance that it enhances overall response rate, or does that sound like that's ruled out?

It was $29 nine months again greater than the reported PFS, forcing religion on that day 2.9 months and you'll grow survivor had not been reached from a combination studies that was presented to again that gives us some you know.

Unknown Executive: Thank you. Our next question comes from the line of Robin Karnakis with Truro Securities. Your line is open.

Robin Karnakis: Hey guys, this is Kaplan for Robin.

Well the evidence and from your early data to support the combination of the day with a recruitment.

Unknown Executive: Thank you so much for taking my question. So, barring the impact of COVID for Kinloch, do you see any additional levers to enhance uptake in fourth line? What sort of feedback have you been getting from doctors, especially around safety? And this is in relation also to the second line program that's ongoing. Can you remind us about the safety concerns around Sutent and if you're hearing anything about a down-dosing regimen that's used in the real world setting? Hi Steve.

On this <unk>.

Thank you.

I'm showing no further questions in the queue.

I would now like to turn the call that go with the C for clothes on remarks.

Great I'd just like to thank all of you for joining us for today's call and thank you for your continued support of decipher we look forward to keeping you updated on our progress throughout the rest of 2021 I Hope you all have a great evening. Thank you.

Steven L. Hoerter: So I'll take that question. And Peter, if you're still listening, we'll come back to your question. I think we were having a mute issue.

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.

Steven L. Hoerter: But I want to come back to the question that you asked as well. So with respect to Sutent and how it's used in a real world setting, yes, I mean, our very consistent feedback that we hear from investigators and from physicians who use this drug is that it is common for the drug to be dosed reduced as a result of tolerability challenges. So that is something that we understand is a fairly common occurrence.

[music].

Steven L. Hoerter: And are you hearing any sort of feedback around Kinloch safety in the real world that is different from what you saw in the clinical settings? We hear, with respect to Kinloch, very consistent feedback that's consistent with our label and the clinical experience and that the drug is well tolerated. And I think physicians view it that way, especially relative to other options that are available to them and to their patients.

Unknown Executive: So I think the drug is viewed as being a well tolerated, effective option for patients. Great. And one more question, if I may.

Steven L. Hoerter: For the data readout from the phase three trial and fourth quarter, what can you tell us about what to expect? Do we see top-line data, whether it met the end point or not, or more detail than that? Or should we expect more detailed presentations at a medical conference later with just the top line?

Steven L. Hoerter: I think it's fair to expect that we'll have a relatively fulsome top-line readout, similar to what we did for the Invictus study when we reported out those data. So we'll seek to provide relevant information on the primary endpoint of the study, as well as the tolerability profile of the drug based on the experience in the intrigue study. Okay, great. Thank you so much.

Peter Richard Lawson: And then I just wanted to come back, Peter, to your question that you asked with respect to the MEK inhibitor combination and whether we might expect to see, you know, more tumor cell killing or more of a cytocidal response with that combination versus simply a prolongation of response. And Matt, I wanted to ask you if you would like to address that based on the preclinical data that we've generated and what's been published online just today.

Peter Richard Lawson: Sure, yeah, I think it's very important to recognize that there was a pilot study that was done; it was an investigative response study at Memorial Sloan-Kettering that was presented at ASCO last year. It was a combination of imatinib and lupinimatinib, so based on the same preclinical rationale that we've discussed today, the investigator there was able to show, in a cohort of about 40 patients, an objective response rate of 68%, and that compares very favorably to the historical activity of about 50% for single-agent imatinib. The progression-free survival from that combination was 29.9 months, again, greater than the reported PFS for single-agent imatinib of 18.9 months, and overall survival has not been reached in the combination study that was presented.

Matthew L. Sherman: So, again, it gives us some, you know, real-world evidence and some, you know, early data to support the combination of imatinib with lupinimatinib in this planned study. Thank you. I'm showing no further questions in the queue. I would now like to turn the call back over to Steve for closing remarks. Great. I'd just like to thank all of you for joining us on today's call and thank you for your continued support of Decipher.

Matthew L. Sherman: We look forward to keeping you updated on our progress throughout the rest of 2021. I hope you all have a great evening. Thank you. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

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