Q4 2020 Deciphera Pharmaceuticals Inc Earnings Call

Good afternoon, everyone and welcome to the cipher Pharmaceuticals fourth quarter on full year 2020 financial results Conference call. Today's call is being recorded at this time I'd like to turn the call over to Jen Robinson, Vice President Investor Relations Jan.

Unknown Executive: Good afternoon, everyone, and welcome to Decipher Pharmaceutical's fourth quarter and full year 2020 Financial Results Conference call. Today's call is being recorded. At this time, I'd like to turn the call over to Jen Robinson, Vice President, Investor Relations.

Jennifer Larson: Welcome and thank you for joining us today to discuss Deciphera's fourth quarter and full year 2020 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.

Welcome and thank you for joining us today to discuss the Cyprus fourth quarter and full year 2020 financial results on <unk>.

Jen Robinson, Vice President Investor Relations at Syros with me. This afternoon to discuss the financial results and provide a general corporate update are Steve Herbert 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 examples of forward looking statements made during this conference call.

Jennifer Larson: Examples of forward-looking statements made during this conference call include our expectations for our preclinical and clinical programs, our Commercialization of Kinloch, 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 annual report on Form 10-K, as well as in our other SEC documents. We assume no obligation to update or revise any forward-looking statements.

Include our expectations for our preclinical and clinical programs, our commercialization of <unk> and 'twenty 'twenty one 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 statements and we cannot assure you that our expectations will be achieved such risks and uncertainties include those set forth on our most recent annual report on form 10-K, as well as our other SEC documents.

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 Ww dot <unk> dot com with that I will now turn the call over to Steve Herbert President and Chief Executive Officer of decipher steep.

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

Steven L. Hoerter: Thank you, Jim. Good afternoon, everyone, and thank you for joining us on today's call. The fourth quarter capped a landmark year for Deciphera, in which we launched our first medicine, Kenlock, reported encouraging data from the product candidates in our pipeline, and filed the IND for a new product candidate entering the clinic this year. This progress would have been impressive in any year, but I'm particularly proud of our team for accomplishing all this in the midst of the ongoing COVID-19 pandemic. The team here at Deciphera adapted quickly, and as a result of their hard work, dedication, and patient focus, we achieved the ambitious goals we outlined at the beginning of 2020.

Thank you Jim Good afternoon, everyone and thank you for joining us on today's call the fourth quarter caps, a landmark year for the site growth and which we launched our first medicine Kinloss reported encouraging data from the product candidates on our pipeline and filed the IND for a new product candidates entering the clinic this year.

This progress would have been impressive in any year, but I'm, particularly proud of our team for accomplishing all of this in the midst of the ongoing COVID-19 pandemic.

Team here at decipher adapted quickly and as a result of their hard work dedication and patient focus we achieve the ambitious goals, we outlined at the beginning of 2020.

Steven L. Hoerter: This work positions us well for 2021 as we seek to expand the opportunity with Kenlock and set the stage for our next wave of growth. For Kinloch, we have three specific priorities for 2021. First, we are continuing to execute on the successful launch of KenLock for the treatment of patients with fourth-line gastrointestinal stromal tumors, or GISTs, in the United States. Kinloch has the potential to change the treatment of advanced JIS, and we have made great progress delivering this important new medicine to eligible patients in the fourth-line setting.

This work positions us well for 2021, as we seek to expand the opportunity with Kimball and set the stage for our next wave of growth.

For Kinlaw, we have three specific priorities in 2021.

First we are continuing to execute on the successful launch of kinlaw for the treatment of patients with fourth line gastrointestinal stromal tumors or just in the United States.

<unk> has the potential to change the treatment of advanced <unk> and we have made great progress in delivering this important new medicine to eligible patients in the fourth line setting.

Steven L. Hoerter: Dan Martin, our Chief Commercial Officer, will share the commercial highlights from the fourth quarter in a few minutes. Second, we are committed to expanding the geographic reach for ChemLock, and we are rapidly advancing our efforts on this front. This past summer, we received regulatory approval for Kenlock in Canada and Australia and selected distribution partners who are responsible for commercializing Kenlock in these territories.

San Martin our Chief commercial officer will share the commercial highlights from the fourth quarter in a few minutes.

Second we are committed to expanding the geographic reach for Kenmore, and we are rapidly advancing our efforts on this front. This past summer we received regulatory approval for Ken Lock in Canada, and Australia and selected distribution partners, who are responsible for commercializing <unk> in these territories.

Steven L. Hoerter: And China, our partner Xi Lab, filed the NDA for Kinloch last summer and has guided us to a potential approval in the first half of this year. And finally, we received validation from the European Medicines Agency, or EMA, for the marketing authorization application for Kinloch in fourth-line GIS, setting us up for a potential EMA approval in the second half of 2021. As we continue our efforts to bring KenLock to patients in Europe and around the world, we are very excited to announce today the appointment of Margarida Duarte, Senior Vice President, Head of International Relations, at KenLock.

In China, our partners on lab filed the NDA for Ken lot last summer and have guided to a potential approval in the first half of this year.

And finally, we received validation from the European Medicines agency or EMA for marketing authorization application for Kinlaw in fourth line gist setting us up for a potential PMA approval in the second half of 2021.

As we continue our efforts to bring him lots of patients in Europe and around the world. We are very excited to announce today the appointment of Margarita Duarte as senior Vice President head of international.

Steven L. Hoerter: Margarida joins us from Alnylam Pharmaceuticals, where she most recently was vice president of commercial for Canada, Europe, the Middle East, and Africa. She was responsible for a number of important, successful new product launches at Al-Nasr and brings to Deciphera over 15 years of experience in the global pharmaceutical industry with expertise in commercializing innovative products in the EU and worldwide. I know that her deep commercial and operational expertise will be an incredible asset to Deciphera, and I look forward to working with Margarida as we continue our mission to deliver important new medicines to patients.

Margarita joins us from now on Island Pharmaceuticals, where she most recently was vice president of commercial for Canada, Europe, Middle East and Africa.

She was responsible for a number of important and successful new product launches that on idle and brings to the site for over 15 years of experience on the global pharmaceutical industry with expertise in commercializing innovative products in the EU and internationally.

I know that are deep commercial and operational expertise will be an incredible asset to the site for us and I look forward to working with Margarita as we continue our mission to deliver important new medicines to patients.

Steven L. Hoerter: The third focus for KENLOCK is expanding into earlier lines of therapy and GIST. In particular, we see a significant opportunity for KENLOCK to offer benefit to patients in the larger second-line GIST population. In the fourth quarter, we completed enrollment in our Pivotal Phase III Intrigues study in the second line and are on track for a top-line data readout in the second half of this year. Behind Kenloch, we have a robust, maturing pipeline of wholly owned programs.

The third focus for Ken lock is expanding into earlier lines of therapy and Jess in particular, we see significant opportunity for kinlaw offer benefit to patients and the larger second line Gist population.

In the fourth quarter, we completed enrollment in our pivotal phase III intrigue study in the second line and are on track for a top line data readout in the second half of this year.

Behind Ken Mark we have a robust maturing pipeline of wholly owned programs. During the course of this year, we expect the potential of this pipeline to come into sharper focus.

Steven L. Hoerter: During the course of this year, we expect the potential of this pipeline to come into sharper focus. On the call today, Matt Sherman, our Chief Medical Officer, will highlight recent progress from the Vimseltenib and Rivastinib programs, which have both demonstrated strong initial clinical data in their respective potential indications. We expect to share additional data for both programs throughout the year, as well as updates on potential pivotal developments. Matt will also provide more details on the newest addition to our clinical pipeline, DCC 3116, including the Phase I study design and the preclinical data package that supports the potential for 3116.

On the call today, Matt Sherman, our Chief Medical Officer.

Highlight recent progress from the Vim, Seltzer nib and robust in our programs, which have both demonstrated strong initial clinical data in their respective potential indications, we expect to share additional data for both programs throughout the year as well as updates on potential pivotal development plans, Matt will also provide more details around the newest edition.

Turning to our clinical pipeline DCC 31, 16, including the Phase one study design and the preclinical data package to support the potential for 31 16.

Steven L. Hoerter: As a novel, potential first-in-class ulc kinase inhibitor, we believe DCC3116 has the potential to benefit the large group of patients with mutant RAS and RAF cancer. I'll now turn the call over to Dan Martin, our Chief Commercial Officer, to discuss the results for the second full quarter of Kenlock Commercial Sales.

As a novel potential first in class <unk> kinase inhibitor. We believe DCC 31, 2016 has the potential to benefit the large group of patients with mutant Ras <unk> cancers.

I'll now turn the call over to Dan Martin, Our Chief commercial officer to discuss the results for the second full quarter of Kinlaw commercial sales Dan.

Daniel C. Martin: Thank you, Steve. Good afternoon. Today I'm pleased to report the results of our second full quarter of Kinloch sales and to provide some color regarding our expectations as we look ahead. We continue to be extremely pleased with the Kinloch launch and with our rapid penetration of the Fourth Line operation. In Q4, we achieved $19.5 million in total net product revenue, including $18.5 million in the U.S., which equates to 26% quarter-over-quarter growth and brings total launch-to-date U.S. net product revenue to $38 million. Prior to the U.S. launch of Kinloch, we identified two primary... The first was to rapidly establish Kinloch as the clear standard of care in fourth-line care.

Thank you, Steve and good afternoon today I am pleased to report the results of our second full quarter of <unk> sales and to provide some color regarding our expectations as we look ahead.

We continue to be extremely pleased with the can lock launch and with our rapid penetration on the fourth line opportunity in Q4, we achieved $19 5 million and total net product revenue, including $18 5 million in the U S, which equates to 26% quarter over quarter growth and brings total loss.

Year to date U S net product revenue to $38 million.

Prior to the U S launch of Kinloch, we identified two primary goals. The first was to rapidly establish <unk> as the clear standard of care in fourth line Gist.

Daniel C. Martin: The second was to leverage our approved indication to build a strong foundation for a potential second line launch by establishing a broad and diverse prescriber base and by achieving positive product perceptions among Kinloch users. Based on our strong launch results and multiple key performance, we believe we have made tremendous progress toward these goals since launch. Our recent market research indicates that during Q4, our sales and marketing teams achieved the highest prescriber reach and product share of voice among all companies in the GIST market.

What's the leverage our approved indications to build a strong foundation for a potential second line launch by establishing a broad and diverse prescriber base and by achieving positive product perception among <unk> users.

Based on our strong launch results and multiple key performance metrics. We believe we have made tremendous progress toward these goals since launch.

Our recent market research indicates that during Q4, our sales and marketing teams achieved the highest prescriber reach and product share of voice among all companies in the jet market.

Daniel C. Martin: In addition, this research showed that despite the challenges of the pandemic, we have rapidly increased awareness of Kinloch over the last two quarters. In fact, among physicians treating late-line GIST patients, awareness of Kinloch was similar to that of established products that have been approved for the treatment of GIST for many years. Our commercialization efforts resulted in rapid update by a broad and diverse prescriber population. We estimate that from launch through Q4, over 350 prescribers from more than 300 institutions have prescribed Kinloch. During Q4, as expected, slightly more than half of both new and total prescribers came from the community setting.

In addition, this research shows that despite the challenges of the pandemic, we have rapidly increased awareness of kinloch over the last two quarters in fact, among physicians treating late line gist patients awareness of Kinloch with similar to that of established products that have been approved for the treatment of <unk> for many years.

Our commercialization efforts resulted in rapid uptake by a broad and diverse subscriber base, we estimate that from launch through Q4 over 350 prescribers for more than 300 institutions are prescribed cannot.

During Q4 as expected slightly more than half of both new and total prescribers came from the community setting.

Daniel C. Martin: Conversely, slightly more than half of total patients treated during the quarter came from the academic setting, which highlights the fact that the number of patients per physician is higher in the academic setting, consistent with our pre-launch understanding. To date, nearly all of our highest priority accounts and physicians, irrespective of practice setting, have either prescribed Kinloch or have identified patients for future Kinloch treatment when those patients progress to the fourth line. And importantly, our market research indicates that prescribers have had very favorable experiences with Kinloch, with users citing both positive product perceptions and high fourth-line patient share.

Conversely.

More than half of total patients treated during the quarter came from the academic setting which highlights. The fact that the number of patients per physician is higher in the academic setting consistent with our prelaunch understanding.

To date, nearly all of our highest priority accounts and physicians irrespective of practice setting have either prescribed kinloch or have identified patients for future kinloch treatment when those patients progressed to the fourth line.

And importantly, our market research indicates that prescribers have had very favorable experiences with kinloch with user siding growth positive product perceptions, and hi fourth line patient share.

Daniel C. Martin: Additionally, our market access team continued to deliver broad patient access to Kinloch in Q4. Payor coverage for Kinloch has remained very strong, with policies aligned to our FDA label. As expected, the percentage of patients that received free drugs under our Patient Assistance Program, or PAP, was slightly higher in Q4 due to the increased affordability challenges that commonly impact Medicare patients late in the year, but it still fell within our 20-30% estimated range. As previously communicated, our PAP percentage in Q1 may be impacted by the Medicare Part D benefit reset that occurs at the beginning of the year, which requires patients to pay for their deductible and their portion of the coverage gap before reaching the catastrophic coverage tier.

Additionally, our market access team continued to deliver broad patient access to Ken lock in Q4 payer coverage for Kinloch has remained very strong with policies aligned to our FDA label as.

As expected the percentage of patients that received free drug under our patient assistance program or pop was slightly higher than Q4 due to the increased affordability challenges that commonly impact Medicare patients late in the year, but fell within our 20% to 30% estimated range.

As previously communicated our <unk> percentage in Q1 may be impacted by the Medicare part D benefit reset that occurs at the beginning of the year, which.

Which requires patients to pay for their deductible and their portion of the coverage gap before reaching the catastrophic coverage here.

Daniel C. Martin: We continue to expect our PAP percentage to be in the 20-30% range on average over the course of the year. Looking forward, we anticipate that our next phase of significant growth will come with our expansion into second-line GIST, pending positive data from Intrigue and subsequent improvements. Until then, we anticipate that future quarter-over-quarter growth will moderate and be determined largely by how patient persistency develops in the real world setting. In the near term, our focus will be on working with existing academic and community prescribers to optimize the identification of appropriate patients for Kinloch, while continuing our efforts to gradually expand our prescriber footprint.

We continue to expect our pap percentage to be in the 20% to 30% range on average over the course of the year.

Looking forward, we anticipate that our next phase of significant growth will come with our expansion into second line gist pending positive data from intrigue and subsequent approval.

Until then we anticipate that future quarter over quarter growth will moderate and be determined largely by how patient persistency develops on the real world setting.

In the near term our focus will be on working with existing academic and community prescribers to optimize identification of appropriate patients for Kim Locke, while continuing our efforts to gradually expand our prescriber footprint.

Daniel C. Martin: Finally, as we look ahead to the intrigue readout later this year and to a potential second line approval, we remain extremely optimistic about the potential for Kinloch to continue to transform the treatment of GIST. We believe high awareness of Kinloch and positive product perceptions, coupled with a broad prescriber base across both academic and community settings, has established a strong foundation for a successful launch in the second line setting, pending approval. Feedback from GIST treaters, including GIST thought leaders, continues to give us confidence that Kenlock has the potential to establish a new standard of care in second-line GIST. Given the larger patient population in second line and what we expect to be increased persistency, a second line approval represents a truly transformative opportunity for Kinloch and, most importantly, for patients with GIST.

Finally, as we look ahead to the intrigue readout later this year and to a potential second line approval, we remain extremely optimistic about the potential for kinlaw to continue to transform the treatment of Gist, We believe high awareness of Ken lock and positive product perceptions, coupled with a broad prescriber base across both academic and community settings.

<unk> has established a strong foundation for a successful launch on the second line setting pending approval.

Feedback from Gist treaters, including just thought leaders continues to give us confidence that <unk> has the potential to establish a new standard of care in second line Gist.

Given the larger patient population in second line Gist and what we expect to be increased persistency. A second line approval represents a truly transformative opportunity for Kinloch and most importantly for patients with just I will now turn the call over to Matt to discuss the progress of our clinical programs Matt.

Daniel C. Martin: I will now turn the call over to Matt to discuss the progress of our clinical programs. Thank you, Dan. We continue to make great strides across our growing pipeline of novel switch-control kinase inhibitors. Let me start with Kinloch.

Thank you Dan.

We continue to make great strides across our growing pipeline of novel switch control kinase inhibitors.

Start with Kumar.

Matthew L. Sherman: At the end of last year, we completed enrollment in our Phase III Intrigue Study investigating kidnapping patients with second-line GIST and remain confident in the likelihood of success in this pivotal study. The preclinical profile of Kinloch demonstrates that it broadly inhibits kit mutations that drive the disease across all lines of therapy. In addition, we have a strong clinical data package, not only with the exceptional results from the Phase III Infectious Study in fourth-line plus patients but also the compelling results in the Phase I study, showing that clinical efficacy continues to improve in patients with second-line through fourth-line plus chest.

At the end of last year, we completed enrollment in our phase III intrigue study investigating to margin patients with second line Gist.

I'm confident in the likelihood of success in this pivotal study.

The preclinical profile of Kinloch demonstrates that broadly inhibits kit mutations that drive the disease across all lines of therapy.

In addition, we have a strong clinical data package.

With the exceptional results from the Phase III Invictus study in fourth line plus patients, but also the compelling results on the phase one study showing the clinical efficacy continues to improve on patients with second line through fourth line plus chips.

Matthew L. Sherman: We believe that Kinloch may provide significant benefits to GIST patients in the second-line setting and look forward to reporting top-line data from the INTRIGUE study, which we project to read out in the second half of this year. Turning to Vimseltamide, our potent and selective inhibitor of CSF1R, which is in development for the treatment of tenosynovial giant cell tumor, or TGCT. Patients with TGCT experience a significant disease burden and commonly report multiple symptoms, including pain, limited function, swelling, and stiffness.

We believe that <unk> may provide significant benefits just patients in the second line setting and we look forward to reporting topline data from the <unk>, which we project to read out on the second half of this year.

Turning to do sell to noon hour per.

<unk> selective inhibitor.

Just one or in development for the treatment of tendency mobile giant cell tumor or <unk>.

Patients with TCT experienced significant disease burden and commonly reported multiple symptoms, including seen limited function swelling and stiffness.

Matthew L. Sherman: The only approved systemic therapy for patients with TTCP is texidartanib, which has a boxed warning and is subject to a REMS program due to hepatitoxicity, an adverse event that is thought to be an off-target effect. We believe that Dimfeltinib has the potential to be best in class and to fulfill the unmet medical need for an effective and well-tolerated treatment for patients with TGCT At the Connective Tissue Oncology Society meeting last year, we presented encouraging preliminary results from the ongoing Phase 1-2 study of imsteltenib in patients with TGCT.

The only approved systemic therapy for patients with <unk> T is Texas Garten, which has a box warning and is subject to a rems program due to the hotel.

Total toxicity.

Adverse event that is thought to be an off target effect.

We believe that <unk> has the potential to be best in class and to fulfill the unmet medical need for them effective and well tolerated treatment for patients with <unk>.

At the connective tissue oncology Society meeting last year, we presented encouraging preliminary results from the ongoing phase <unk> study on <unk> in patients with <unk> the.

Matthew L. Sherman: The trial is progressing well, and we look forward to sharing additional data updates from the study and are planning to finalize and unveil our pivotal development plans later this year. Turning to ribacinib, our potentially first-in-class, potent, and selective inhibitor of the TIE2 kinase.

<unk> is progressing well and we look forward to sharing additional data updates from the study and are planning to finalize and unveil our pivotal development plans later this year.

Turning to ADESA.

Our potentially first in class potent and selective inhibitor of the <unk>.

Matthew L. Sherman: We are very encouraged by the initial clinical data we presented last year from both the endometrial and platinum-resistant ovarian cancer cohorts in our Phase 1B-2 study in combination with Paclitax. We have reached full enrollment for these cohorts and are continuing to enroll patients in stage one of the carcinocercoma and inflammatory breast cancer cohorts. In the other Phase 1B2 study, in combination with carboplatin, enrollment in Part 2, Stage 1 of the platinum-sensitive ovarian cancer cohort has been completed, and efficacy and safety evaluation are ongoing.

We are very encouraged by the initial clinical data, we presented last year from both the endometrial and platinum resistant ovarian cancer cohorts in our phase <unk> study in combination with Paclitaxel.

We have reached full enrollment for these cohorts and are continuing to enroll patients with stage, one with the carcinosarcoma and inflammatory breast cancer cohorts.

And the other phase <unk> study in combination with Carboplatin enrollment in part two stage, one, but the platinum sensitive ovarian cancer cohort has been completed.

And safety evaluation is ongoing.

Matthew L. Sherman: For endometrial cancer, there are limited treatment options after Paclitaxel and carboplatin in the first-line setting and Pembrolizumab and Levatin in the second-line setting. Beyond second line, treatment is very heterogeneous and generally offers patients a progression-free survival benefit of only three to four months with objective response rates of just 10 to 20%. At ASCO last year, we presented encouraging data in 21 patients from the Phase 1B2 study, where we saw a confirmed and unconfirmed response rate of 39% and a clinical benefit rate at eight weeks of 72%.

For endometrial cancer, there are limited treatment options after paclitaxel Carboplatin in first line <unk>.

Timber listen that and was that in the second line study.

Beyond second line treatment is very heterogeneous and Germany office patients on progression free survival benefit of only three to four months with objective response rates, but just 10% to 20%.

It has to last year, we presented encouraging data in 21 patients from the phase <unk> study.

Are we sort of confirmed and unconfirmed response rate of 39% and a clinical benefit rate at eight weeks of 72%.

Matthew L. Sherman: All of the patients enrolled in this study had received prior paclitaxel therapy, and nearly 60% had received more than three lines of prior treatment. For the platinum-resistant ovarian cancer cohort, we presented data at ESMO last year.

Well look on patients enrolled in this study had received prior <unk> therapy, and nearly 60% had received more than three lines of prior treatment.

For the platinum resistant ovarian cancer cohort, we presented data at ESMO last year similar to endometrial cancer treatment of later line platinum resistant disease is very heterogeneous and generally office patients on progression free survival benefit with three to four months with objective response rates with 15% to 25.

Matthew L. Sherman: Similar to endometrial cancer, treatment of later-lying platelet-resistant disease is very heterogeneous and generally offers patients a progression pre-survival benefit of three to four months with objective response rates of 15 to 25%. In our study, the combination of verbacinib with paclitaxel had a confirmed and unconfirmed response rate of 38%, and the clinical benefit rate at eight weeks was 88%. Nearly 80% of these patients had received four or more prior anti-cancer regimens. We're encouraged by both the safety and efficacy profile of the combination in this heavily pre-treated population.

Percentage.

In our study the combination of <unk> with Paclitaxel have been confirmed and unconfirmed response rate of 38%.

On the clinical benefit.

88%.

Nearly 80% of these patients had received four or more prior anti cancer regimens.

We're encouraged by both the safety and efficacy profile of the combination in this heavily pretreated population.

Matthew L. Sherman: Our focus with this program is to continue driving forward as quickly and prudently as we can. Assuming continued positive data, we expect to finalize a potential pivotal development plan for ribacinib in combination with paclitaxel in the second half of this year. With enrollment completed in the endometrial and platelet-resistant ovarian cancer cohorts, we are looking forward to providing data updates in these indications later this year. Finally, we continue to be extremely excited about DCC3116, our potential first-in-class bulk kinase inhibitor designed to treat cancer patients in combination with RAS and MAP kinase signaling pathway inhibition, particularly in patients with RAF or BRAF mutations.

Our focus with this program is to continue driving forward as quickly and prudently as we can and assuming continued positive data we expect to finalize the potential pivotal development plan for the best and that in combination with Paclitaxel in the second half of this year.

With enrollment completed in the endometrial and platinum resistant ovarian cancer cohorts, we're looking forward to providing data updates in these indications later this year.

Finally, we continued to be extremely excited about DCC 3116 on potential first in class book.

Inhibitor designed to treat cancer patients in combination with RAF and map kinase signaling pathway inhibition, particularly in patients with Ras BRAF mutations.

Matthew L. Sherman: I am pleased to announce that we have received FDA clearance for the DCC 3116 IMD, and we expect to begin our first in-human study in the second quarter of this year. The mechanism of action of DCC3116 combined with the emerging preclinical data supports broad development in combination with MAP kinase inhibitors. The oak complex is the initiating factor in the autophagy pathway, a key survival pathway.

I am pleased to announce that we have received FDA clearance for the <unk> 16, IMD and we expect to begin our first in human study in the second quarter of this year.

The mechanism of action with DCC 3116, combined with the emerging preclinical data supports broad development in combination with map kinase inhibitors.

<unk> complex as the initiating factor.

<unk> pathway, a key survival pathway.

Matthew L. Sherman: Mutant RAF and RAF cancers are reported to have high basal levels of autophagy, which these cancers use to maintain nutrient supply and regulate cancer cell metabolism and survival. Cellular studies in mutant RAS and RAF cancers have also demonstrated that treatment with NAP kinase pathway inhibitors can also induce autophagy as a compensatory survival mechanism. As we have previously shared, preclinical data supports this approach, showing the synergistic anti-proliferative and anti-tumor activity of DCC3116 in combination with the inhibition of RAS-MAP kinase signaling in mutant RAS and RAS cancer.

Mutant Ras and RAF Kansas are reported on a high basal levels of Autophagy.

Which these cancers used to maintain nutrient supply and regulate cancer cell metabolism and survival.

So we were studies mutant Ras cancers have also demonstrated that treatment with map kinase pathway inhibitors can also induce autophagy is a compensatory survival mechanism.

As we have previously shared the preclinical data supports this approach showing the synergistic anti proliferative anti tumor activity of DCC 31, 16 in combination with the inhibition of RASK net <unk> signaling the mutant Ras RAF cancers.

Matthew L. Sherman: This provides us with a number of development opportunities for TCC3116 in combination with a RAS-MAP kinase signaling pathway inhibitor, such as NEC inhibitors, ERK inhibitors, or KRAS G12C inhibitors, that could potentially establish a new treatment paradigm for RAS and RAS mutant cancer. More than 30% of all human cancers are driven by mutations of the RAS and RAF genes, yet these cancer We are excited to initiate our Phase 1 study in the second quarter of this year, which will evaluate 3116 alone and in combination with Tremetinib, an FDA-approved MEK inhibitor, in patients with advanced or metastatic tumors with a mutant RAF or RAF gene.

This provides us with a number of development opportunities for <unk> 31, 16 in combination with the rest map kinase signaling pathway inhibitor, such as neck inhibitors, <unk> inhibitors, or <unk> inhibitors that could potentially establish a new treatment paradigm and RAF and BRAF mutant cancers.

On the 30% of all human cancers are driven by mutations of bras and ramp genes that these kansas continues to be underserved.

We are excited to initiate our phase one study in the second quarter of this year, which will evaluate 31 16 alone and in combination with true and FDA approved <unk> in patients with advanced or metastatic tumors with a mutant Ras RAF Jeep.

Matthew L. Sherman: After the safety and tolerability of 3116 as a single agent are determined, the first cohort of the combination dose escalation will open for enrollment. The dose expansion phase will be initiated after the recommended phase two dose of the combination is determined and will include cohorts for patients with pancreatic ductal adenocarcinoma, non-small cell lung cancer, colorectal cancer, and melanoma harboring a mutation in We are strongly encouraged by the progress across each of the programs in our pipeline and believe 2021 will be an important year in the development of these assets as we look to make a meaningful difference in the treatment of patients with cancer.

After the safety and Tolerability with 31 2016 as a single agent has determined the first cohort the combination dose escalation will open for enrollment.

The dose expansion phase will be initiated after the recommended phase II dose for the combination is determined and will include cohorts of patients with pancreatic ductal adenocarcinoma non small cell lung cancer, colorectal cancer and melanoma harboring <unk> mutation and the rest RAF pathway.

We are strongly encouraged by the progress across each of the programs on our pipeline and believe 2021 will be an important year in development of these assets as we look to making a meaningful difference on the treatment of patients with cancer.

Matthew L. Sherman: I will now turn the call over to Tucker Kelly, our Chief Financial Officer, to review the financial results. Thanks Matt. I'd like to review the highlights for our fourth quarter and full year 2020 financial results. Total revenue for the fourth quarter was $19.5 million, which included $18.5 million in U.S. net product sales.

I will now turn the call over to Tucker Kelly, our Chief Financial Officer to review the financial results quicker.

Tucker.

Thanks, Matt I'd like to review the highlights of our fourth quarter and full year 2020 financial results.

Total revenue for the fourth quarter was $19 5 million, which includes $18 5 million in U S net product sales.

Thomas Patrick Kelly: Consisting of the third quarter, the growth to net adjustment in the fourth quarter was slightly lower than our annualized estimate of 15%. Total revenue for the full year was $42.1 million, comprised of net product sales of $39.5 million, including $38 million in U.S. net product sales, as well as approximately $2.6 million in collaboration revenue. The cost of sales for the 3 and 12 months ending December 31, 2020, 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.

Consistent with the third quarter, the gross to net adjustment in the fourth quarter was slightly lower than our annualized asking on the 15%.

Total revenue for the full year was $42 1 million comprised of net product sales to $39 5 million, including $38 million in U S. Net product sales as well as approximately $2 6 million in collaboration revenue.

Cost of sales for the three and 12 months ending December 31, 2020 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.

Until the initial prelaunch inventories depleted and additional inventories manufacturing so cost of sales will not be significant and we expect the cost of sales will remain immaterial in 2021.

Total operating expenses were $82 5 million in the fourth quarter of 2020 compared to total operating expenses of $70 4 million in the same period in 2019 for.

Thomas Patrick Kelly: Until the initial pre-launch inventory is depleted and additional inventory is manufactured and sold, cost of sales will not be significant, and we expect that cost of sales will remain immaterial in 2021. Total operating expenses were $82.5 million in the fourth quarter of 2020 compared to total operating expenses of $70.4 million in the same period in 2019. For the full year 2020, total operating expenses were $313.3 million compared to total operating expenses of $225.7 million in 2019.

For the full year 2020, total operating expenses were $313 3 million compared to total operating expenses of $225 7 million in 2019.

Research and development expenses in the fourth quarter were $52 3 million compared to $46 6 million in the same period in 2019.

For the full year 2020, R&D expenses were 199 million compared to $157 6 million in 2019.

Selling general and administrative expenses in the fourth quarter were $30 1 million compared to $23 7 million in the same period in 2019 and for the full year 2020, SG&A expenses were $114 1 million compared with $68 1 million in 2019.

Thomas Patrick Kelly: Research and development expenses in the fourth quarter were $52.3 million, compared to $46.6 million in the same period in 2019. For the full year 2020, R&D expenses are expected to be $199 million, compared to $157.6 million in 2019. Selling General and Administrative Expenses in the fourth quarter were $30.1 million, compared to $23.7 million in the same period in 2018.

We continue to expect that our operating expenses will increase in 2021 as compared to 2020 as we invest in the development of our clinical pipeline continue to execute on the commercial launch of <unk> in the U S and prepare for a potential commercial launch in Europe.

We ended the fourth quarter on a strong financial position and remain well capitalized with cash cash equivalents and marketable securities of approximately $561 million, which we expect to be sufficient to fund our operations into the second half of 2022 and with that I'll now turn the call back over to Steve.

Thomas Patrick Kelly: And for the full year 2020, SG&A expenses were $114.1 million compared with $68.1 million in 2019. We continue to expect that our operating expenses will increase in 2021 as compared to 2020 as we invest in the development of our clinical pipeline, continue to execute on the commercial launch of Kinloch in the U.S., and prepare for a potential commercial launch in Europe. We entered the fourth quarter in a strong financial position and remain well capitalized with cash, cash equivalents, and marketable securities of approximately $561 million, which we expect to be sufficient to fund our operations into the second half of 2022. And with that, I'll now turn the call back over to Steve. Thank you, Tucker. I'm extremely proud of what our team accomplished in 2020.

Thank you Tucker I'm extremely proud of what our team accomplished in 2020, and we expect 2021 to be a year with significant milestones. We look forward to building upon the momentum of the cannot launch by solidifying its position among just prescribers and patients in the U S. While also taking the regulatory and commercial steps necessary.

To bring him lots of patients with advanced just around the world.

On the clinical development front, we expect the readout of the pivotal phase III intrigue study to potentially expand can lock into the larger second line Gist population and we expect significant clinical updates on two programs that could support advancement into registration enabling studies.

Finally, we look forward to initiating the first in human study for a potential first in class product candidate addressing one of the largest unmet needs in oncology.

We believe 2021 will be another exciting year in our company's journey to bring important new medicines to patients operator, I'd now like to open the call for Q&A.

As a reminder, ladies and gentlemen to ask a question.

Need to press Star one on your telephone to withdraw your question price the balance sheet. Please.

Steven L. Hoerter: And we expect 2021 to be a year with significant milestones. We look forward to building upon the momentum of the Kenlock launch by solidifying its position among GIST prescribers and patients in the U.S., while also taking the regulatory and commercial steps necessary to bring Kenlock to patients with advanced GIST around the world. On the clinical development front, we expect the readout of the Pivotal Phase III Intrigue Study to potentially expand Kenlock into the larger second-line GIST population.

Based on volume compile the Q&A roster.

Our first question on income from the line of Jessica Fye from J P. Morgan you may begin.

Hey, guys. Good afternoon. Thanks, so much for taking my question.

I was hoping you could elaborate a little bit on the comment you made about.

Future quarter to quarter growth.

Underwriting and being determined by patient persistence.

Is that moderating growth you alluded to the result of substantially penetrating the incident fourth line Gist opportunity, where do you think you are in terms of penetration of setting.

Steven L. Hoerter: And we expect significant clinical updates on two programs that could support advancement into registration-enabling studies. Finally, we look forward to initiating the first in-human study for a potential first-in-class product candidate addressing one of the largest unmet needs in oncology.

Yeah, Hi, Jeff, It's Steve just before I turn it over to Dan who can provide some color I think as we said in the prepared remarks, we're really pleased with how the launch has gone so far and that we've really rapidly established can lock as the standard of care in the fourth line setup.

Steven L. Hoerter: We believe 2021 will be another exciting year in our company's journey to bring important new medicines to patients. Operator, I'd now like to open the call for Q&A. Thank you. As a reminder, ladies and gentlemen, to ask a question, you will need to press star one on your telephone.

And as Dan noted in his prepared remarks, we do expect growth to moderate going forward the channel you'd like to provide some more color on that.

Sure absolutely thanks, Jess for the question.

You had a couple of questions. There. So if I don't quite hit on everything just let me know.

So when we talk about that.

Unknown Executive: And to withdraw your question, press the pound key. Please remember we are compiling the Q&A roster. Our first question will come from Jessica Fye from J.P. Morgan. You may begin. Hey guys, good afternoon.

The phrase growth will moderate.

Like Steve said.

We've just been extremely pleased with the performance of the team.

Ability to rapidly penetrate the fourth line patient population despite the challenges of the pandemic.

Jessica Fye: Thanks so much for taking my question. I was hoping you could elaborate a little bit on the comment you made about future quarter-to-quarter growth moderating and being determined by patient persistency. Is that moderating growth you allude to the result of substantially penetrating the incident or applying just opportunity? Where do you think you are in terms of penetration of this setting? Hi Jess, it's Steve.

And as Steve mentioned it is clear that we have established <unk> as the clear standard of care in fourth line gist across both academic and community settings.

And therefore, while we achieved 26% quarter over quarter growth in Q4, we would expect quarter over quarter growth to slow.

Steven L. Hoerter: Just before I turn it over to Dan, you can provide some color. I think, as we said in the prepared remarks, we're really pleased with how the launch has gone so far and that we've really rapidly established Kenlock as the standard of care in the fourth line setting. And as Dan noted in his prepared remarks, we do expect growth to moderate going forward. But Dan, would you like to provide some more color on that?

On the point about the slow until we achieve the second line expansion pending approval and the point that we made about.

On the persistency is that.

We're about seven plus months I guess two quarters into launch and so as we've mentioned previously.

Previously on previous calls.

And that data is still maturing so we'll be bringing claimed to bring forward. Some additional color on on persistency as we move forward, but that'll be really important to see how that develops on the real world setting.

Daniel C. Martin: Sure, absolutely. Thanks, Jess, for the question. Um, yeah, a couple questions there. So if I don't quite hit on everything, just let me know.

Daniel C. Martin: So when we talk about, um, growth will moderate, like Steve said, we've just been extremely pleased with the performance of the team, the ability to rapidly penetrate the fourth line patient population despite the challenges of the pandemic. And as Steve mentioned, you know, it is clear that we have established Kinloch as the clear standard of care and fourth line just across both academic and community settings. And therefore, while we achieved 26% quarter-over-quarter growth in Q4, we would expect quarter-over-quarter growth to slow and the point about, well, slow until we achieve the second line expansion pending approval, and the point that we made about, The consistency is that, you know, we're about seven plus months, I guess, two quarters into launch.

A number any number of things could impact.

How persistency develops in the real world setting, including efficacy Tolerability patient mix is important both by line of therapy and by performance status.

And then there is also non clinical considerations, such as cumulative emotional financial and administrative burdens on on.

On the patient during.

During their cancer journey. So these are the things that we'll look to see how they play out and impact persistency over time in the real world setting.

Got it thanks for that and maybe just one more.

If you could elaborate on that.

Daniel C. Martin: And so, as we've mentioned previously on previous calls, that data is still maturing. So we'll be bringing, we plan to bring forward some additional color on persistency as we move forward. But it'll be really important to see how that develops in the real world setting.

The data showed that the number of prescribers on the mix there.

Curious, how many prescribers hall.

Written can lock to more than one patient.

Yes, it's a good question.

Don't have that figure off the top of my head there certainly.

Daniel C. Martin: You know, a number, any number of things could impact how persistency develops in the real world setting, including, you know, efficacy, tolerability, patient mix is important both by line of therapy and by performance status. And then, you know, there's also non-clinical considerations, such as Cumulative Emotional, Financial, and Administrative Burden on the patient during their cancer journey. So these are the things that, you know, we'll look to see how they play out and impact persistency over time in a real world setting.

Good.

Portion that have written for more than one patient, but there is a significant.

On number of our prescribers, who have only written for one because they've only had one.

Keep in mind that as we've described.

These patients are rare and general.

In late line gist patients and particularly outside of the academic setting.

They are extremely rare and very sort of diffuse and suddenly dispersed. So a significant portion of our prescriber base would have only prescribed one because that's on many patients they've had so far.

Daniel C. Martin: Got it, thanks for that. And maybe just one more, if you could elaborate on and give some helpful data about the number of prescribers and the mix there. I'm curious how many prescribers have written Kinloch to more than one patient. Yeah, it's a good question. I don't have that figure off the top of my head.

Okay makes sense. Thank you.

Thank you.

Daniel C. Martin: There's certainly a good portion that have written for more than one patient, but there is a significant number of our prescribers who have only written for one because they've only had one patient. Keep in mind that, as we've described, you know, these patients are rare in general, late-line gist patients, and particularly outside of the academic setting, they're extremely rare and very sort of diffuse and thinly dispersed. So a significant portion of our prescriber base would have only prescribed one because that's how many patients they had. Okay, next time.

Next question on costs on line.

Chris Raymond from Piper Sandler.

Your line is open.

Hi, This is Allison <unk> on for Chris. This afternoon. Thanks for taking the question.

So one just on earlier.

Earlier line use I guess, just some of our.

Survey work has indicated that most cannot use is on label and first line patients.

So on the tactical use in earlier line patients, particularly among.

Docks on the academic setting. So just wondering if you have any color on that dynamic now that you're on a couple of quarters into launch.

Christopher Joseph Raymond: Our next question will come from the line of Chris Raymond from Piper Sandler. Your line is open. Hi, this is Alison Bracelon on behalf of Chris this afternoon.

So just could you talk to that and it's on earlier line use.

It could be.

Contributing to growth.

Alison Bracelon: Thanks for taking the question. So one just on earlier line use, I guess some of our survey work has indicated that most Kenlock use is unlabeled in fourth line plus patients, but there's some detectable use in earlier line patients, particularly among docs in the academic setting. So just wondering if you have any color on that dynamic now that you're a couple quarters into launch. Could you talk about that and whether some earlier line use could be contributing to growth throughout 2021? Yeah, thanks for the question, Allison. I'll ask Dan to take that.

About 2020 line.

Yeah. Thanks for the question Allison I'll ask Dan to take that Dan.

Yes. Thank you Allison good question.

And we did see the survey that you guys did in <unk>.

Generally speaking we thought it was relatively consistent fanatically with what we've said before and what we saw in Q4, we've said before that while it is challenging to SaaS.

With certainty.

Used by line of therapy.

When we sort of triangulate with available data sources, we have we feel strongly that the significant majority of use that we've seen is in the fourth line setting consistent with label and there has been some.

Daniel C. Martin: Yeah, thank you. Allison's a good question. We did see the survey that you guys did. And, you know, generally speaking, we thought it was, you know, relatively consistent thematically with what we've said before and and what we saw in q4. We've said before that, while it's challenging to assess with certainty, use by line of therapy, when we sort of triangulate with available data sources, we have, you know, we feel strongly that the significant majority of use that we've seen is in the fourth line setting consistent with

Earlier line use but again significant majority in the fourth line.

And we've said before that.

Tough to know.

What.

The future holds what we do know is that.

There's a lot of things that drive use on the real world setting of course there is.

Daniel C. Martin: And you know, there has been some earlier line use, but again, a significant majority in the fourth line. The Future Holds, what we do know is that there are a lot of things that drive use in the real world setting, of course, you know, availability of data. We can't promote, of course, to any of that earlier line data.

Availability.

Of data, we can't promote of course to any of that earlier line data I, probably should have started with my my typical disclaimer that we always all of our promotion all of our commercial efforts are targeted toward our labeled indication and so.

What's in the label, what's on payer policies and guidelines and to this point most of all of that is aligned pretty consistently to our approved indication so hard to say, but.

Daniel C. Martin: I probably should have started with my typical disclaimer that all of our promotion, all of our commercial efforts are targeted toward our labeled indication. And so what's in the label, what's in payer policies, what's in guidelines, and to this point, most of all of that is aligned pretty consistently to, you know, our approved indications. So hard to say, but, you know, that's why we've provided the color we have around significantly penetrating the fourth line opportunity rapidly, and we think, as a result of that growth, it is likely to moderate quarter over quarter moving forward until we reach the second line setting pending approval. That makes sense. And maybe just one more.

That's why we've provided the color wheel.

Have around.

Significantly.

Penetrating the fourth line opportunity rapidly and that we think.

As a result of that growth is likely to moderate quarter over quarter moving forward until we reach the <unk>.

Second line setting pending approval.

That makes sense and maybe just one more.

A follow up from.

Steven L. Hoerter: A follow-up from, I think last quarter you had indicated that there might be a little bit of DID dosing, especially based on the data you had last year at ASIMO showing interpatient dose escalation is supportive of treatment path progression. So just hoping you could talk about any updates on those trends and maybe where or how you're thinking about that strategically in terms of getting that data perhaps added to the label or NCCN guidelines and how that plays into the longer-term Kinloch GIST strategy.

I think last quarter, you had indicated that there might be a little bit of.

The IV dosing, especially based on the data.

Good day, all you had last year at ESMO showing.

Intra patient dose escalation.

It's supportive of treatment path progression. So just hoping you could talk to any updates on those trends and maybe where.

Or how youre thinking about that strategically in terms of getting that data.

Perhaps added to the label or NCC on guidelines and how that plays into the <unk>.

Longer term I cannot just strategy. Thanks.

Steven L. Hoerter: So maybe what I'll do first, Alvin, is just comment on the BID data and then ask Dan to talk a little bit about what we actually see in the marketplace and what sort of things would need to happen for that sort of use to be more common, despite the fact that, of course, we can't promote it.

So maybe what I'll do for ourselves on is just comment on the PID data and then a standard to talk a little bit about what we actually see on the marketplace and what sort of things would need to happen for for that sort of use to be more and more common. Despite the fact that of course, we can't promote to it. So as you reference at ESMO last year, we reported data.

Steven L. Hoerter: So, as you mentioned, at ESMO last year, we reported data from the Phase I study, and in the Phase I study, physicians had the opportunity to dose-escalate patients to 150 BID upon progression. And as we shared at ESMO last year, the data that we see in PFS2, so the second progression-free survival interval, is really quite compelling relative to the PFS1 that patients experienced in the study. In the Invictus study, the study that served as the basis for our approval, a similar approach was allowed where physicians were able to dose-escalate their patients to 150 BID.

On the phase one study and the phase one study physicians had the opportunity to dose escalate patients to 150 tid upon progression and as we shared at ESMO last year. The data that we see in TFS too. So the second progression free survival interval is really quite compelling relative to the PFS.

So on the patients' experience on this study in the Invictus study. So the study the surge as the basis for our approval a similar approach was allowed where physicians were able to dose escalate their patients still on <unk> and we're still analyzing those data, but we anticipate being able to present those in the context of a medical meeting at some point in the future. So we.

Steven L. Hoerter: And we're still analyzing those data, but we anticipate being able to present those in the context of a medical meeting at some point in the future, so we think this is a meaningful finding. We don't view either set of data as being label-enabling.

This is a meaningful finding we don't view either set of data is being label, enabling and maybe Dan you want to comment just on what we're seeing commercially and what what sort of factors that play into the ability of physicians to use us.

Steven L. Hoerter: And maybe, Dan, you want to comment just on what we're seeing commercially and what sort of factors would play into the ability of physicians to use this, despite the fact that we can't promote it? Yeah, absolutely. Thank you, Steve. It's a good question.

The fact that we can't promote to it.

Yeah, absolutely. Thank you.

Steve It's a good question and we've.

We continue to see or I should say, we continue to see in Q4, what we've spoke to spoken to before which is we have seen some b I D dosing, but it's been.

Daniel C. Martin: And we've, We continue to see, or I should say we continue to see in Q4 what we've spoken to before, which is we have seen some BID dosing, but it's been a small portion of the overall use, a large majority of our use is at the 150 QD labeled indication. You know, the same drivers really impact an off-label dose, that drive an off-label, you know, data set use. You know, number one, we don't promote the BID data. We're limited, of course, to promoting our labeled dose. And then guidelines and payer policies, which, to this point.

A small portion of the overall use of.

A large majority of our <unk>.

Is that the 150 QD labeled indication.

The same drivers.

<unk> really impact a.

Off label dose driving off label dataset.

Number one we don't promote it.

I'd data were limited of course to promoting our labeled dose.

And then guidelines and payer policies, which to this point.

Daniel C. Martin: You know, continue to be aligned with our labeled dose. So it's not a surprise to us, given those considerations, that the large majority of use is consistent with the 150.

Continue to be aligned with.

Our labeled dose so it's not a surprise to us given those considerations.

At.

The large majority of use is consistent with the $1 50 QD.

Got it thank you.

Alison Bracelon: Thank you. And our next question will come from the line of Michael Schmidt from Guggenheim. The line is open.

And the next question will come from the line on Michael Schmidt from Guggenheim.

Your line is open.

Michael Werner Schmidt: Hey guys, good afternoon. Thanks for taking my questions. I had a pipeline question about DCC 3116. I may have missed it, but could you remind us what the patient population will be in the initial phase one study? Is it all newcomers, or will they be already selected for certain RAS pathway mutations? Hi Michael, it's Steve.

Hey, guys. Good afternoon. Thanks for taking my questions I had a pipeline question about DCC 31 2016.

I may have missed it but did.

Could you remind us what the patient population will be in the initial phase. One study is it all commercial will that'd be already selected for certain Ras pathway mutations.

Yeah, Hi, Michael It's Steve Thanks for the question, Matt would you like to take that.

Steven L. Hoerter: Thanks for the question. Matt, would you like to take this? Yes, hi, thanks for the question. Yes, so in the first in-human study for DCC3116, which is our novel first-in-class autophagy inhibitor, this will be conducted as a two-part study. So the first part will be a dust escalation part of the study, and that will be in all commercial solid tumors, but they will be selected for a mutation in the BRAS pathway, and that will be followed by a second part of the study. We'll be selecting homogeneous patients with specific tumors, pancreatic ductal adenocarcinoma, non-small cell lung cancer, colorectal cancer, and melanoma, and those patients will also be BRAS or BRAF mutation positive. Ununderstood

Yes, hi, thanks for the question, yes, so in the first in human study for a day.

<unk> <unk> hundred 16, which is our novel first in class Autophagy inhibitor.

We conducted a two part study so the first part will be a dose escalation part of the study.

And that would be welcome.

Welcome or solid tumors, but they will be selected for mutations in Nebraska, B RAF pathway.

And that will be followed by the second part of this study will be selecting.

Homogeneous patients with the specific tumors pancreatic ductal adenocarcinoma, non small cell lung cancer, colorectal cancer and melanoma and those patients will also.

The RASK for BRAF mutation positive.

On understood and then Mechanistically is this a drug that might have single agent activity or should we really think about this as a combination drug with other Ras pathway inhibitors.

Matthew L. Sherman: And then mechanistically, is this a drug that might have single agent activity, or should we really think about this as a combination drug with other RAS pathway inhibitors? Yeah, so we believe this is Stripe or B, which is being developed in combination with other signaling pathway inhibitors and initially targeting the RAS-MAP kinase pathway. Okay, that makes sense. Thanks so much, and congrats on the progress. Thank you. Our next question will come from Eun-Yang from Jefferies.

Yes, so we believe that this strength will be.

Developed in combination with other signaling pathway inhibitors, and initially targeting the map kinase pathway.

Okay that makes sense.

Thanks, so much on congrats on a progress.

Thank you.

On that question will come from Ryan.

And on Yang from Jefferies You may begin.

Thank you.

So you know.

Regarding our repetitive aside from just.

Matthew L. Sherman: You may begin. Thank you. So, you know, regarding repratinib, aside from JIST, you have orphan drug designations for other solid tumors like GBM and estracytoma. And in Phase I expansion cohorts, you have been enrolling multiple tumor types. So can you give us an update on other solid tumors aside from JIST? Hi Eun, it's Steve.

Orphan drug designation as a father.

It's all day to generate good luck on GBM in exercise coma and in phase one expansion cohort to you.

Have they have moving enrolling multiple tumor types and so can you give us on update on other solid tumors aside from just.

Yes, Steve Thanks, Thanks for the question.

Eun Kyung Yang: Thanks for the question. And your question goes back to the Phase 1 study. And we provided an update on this on the Q3 call where we talked about the variety of expansion cohorts and what the status of those were. And so at that time, as we discussed, we had completed enrollment, and a number of the cohorts, the melanoma cohort in particular, were still enrolling.

Your question goes back to the Phase one study and we provided an update on this on the Q3 call, where we talked about the variety of expansion cohorts in and what the status of those were in so at that time.

As we discussed.

Ed.

Completed enrollment in a number of the cohorts the melanoma cohort at that stage was was still enrolling and that's data that we will continue to evaluate.

Steven L. Hoerter: And that's data that we will continue to evaluate. But our focus going forward continues to be on exploring the potential for repretinib or Kinloch to benefit patients in CHIPS. Okay, so I guess we are not going to be expecting data from those, you know, non-gist tumors anytime soon, correct? That's right, Eun. Absolutely right.

But our focus going forward continues to be on exploring the potential for where price never Ken lots of benefit patients and just.

Okay.

I guess, so we are not going to be expecting data from.

Debt.

Non gist tumors anytime soon correct.

That's right, Yeah, and exactly what our focus is on just will continue to follow the data that we've collected from the phase one expansion cohort specifically on melanoma and we'll update folks on it when the time is right, but the focus for development going forward as interest.

Steven L. Hoerter: Our focus is on JISC. We'll continue to follow the data that we've collected from the Phase I expansion cohorts, specifically in melanoma, and we'll update folks when the time is right, but the focus for development going forward is JISC.

Eun Kyung Yang: Thank you. And then in terms of a second line gist, so CERTEN is going to go generic in the U.S. and EU this year and next. So is there an example or examples that you can share with us where generic drugs did not impact new superior drugs in cancer settings?

Thank you and then in terms of a second line gist. So so 10 is going to go generic in the U S. On EU this year and next.

No.

Is there any example, examples day you can share with us the win where.

Generic.

Drug because it does not impact new superior drug in cancer settings.

Steven L. Hoerter: Yeah, thanks for the question, Eun. So, Steve, I'll take that. And then, Dan, if you have any additional color you'd like to add, please feel free to jump in. So, as you know, the INTREAD study is a head-to-head study. So, it's Kenlock versus Sunitinib.

Yeah. Thanks for the question so Steve I'll take that and then Dan if you hadn't had any additional color you'd like to add please feel free to jump in so as you know the intrigue study is a head to head studies, so its kinloss versus sunitinib.

Steven L. Hoerter: And as we've discussed previously, we would expect that Sunitinib in that study would demonstrate a PFS in the range of five-and-a-half to six months. And we believe that we would need to demonstrate a two-to-three-month improvement over that for the outcome to be clinically meaningful. So, in other words, Kenlock, we need to demonstrate a two-to-three-month improvement over Sunitinib for that to be viewed as clinically meaningful. Given that this would be a head-to-head study versus the current standard of care, we don't believe that the fact that Sutent could be going generic would have any meaningful impact on physicians' willingness and interest in using a better treatment option for their patients with GIST Dan, do you have anything else that you'd add to that?

As we've discussed previously we would expect that Sunitinib in that study would demonstrate a PFS in the range of five five to six months and we believe that we would need to demonstrate a two to three months of improvement over that for the outcome to be clinically meaningful so in other words, Ken Lockwood and it's been demonstrated two to three months improvement over so net net for that to be viewed as.

Clinically meaningful given that this would be a head to head study versus the current standard of care. We don't believe that the fact that suits them to be going generic would have any meaningful impact on physicians willingness and interest in using a better treatment option for their patients with Jess candy on anything else that you'd add to that.

Steven L. Hoerter: I would just add that, you know, when we think about the different stakeholders, from physicians, as Steve mentioned, to payers and patients, you know, like Steve said for physicians, but I would also add for payers, historically speaking, the gold standard for assessing different product alternatives has been head-to-head comparison in a large randomized phase three trial. And so, if Intrigue is positive, which to our knowledge would be the first and only positive phase three head-to-head study in GIST, you know, we believe that puts us in a really good position.

I would just add debt when we think about the different stakeholders.

From physicians as Steve mentioned to payers and patients like Steve said for physicians, but I would also add for payers.

Shortly speaking the gold standard has been.

In assessing different product alternatives has been head to head comparison on large randomized phase II trial on so.

If intrigue is positive which to our knowledge would be the first and only positive phase III head to head study and just we believe that puts us in a really good position.

Steven L. Hoerter: And then from a patient perspective, we will continue to do what we always do, which is everything we're permitted to do with, you know, in line with relevant laws and regulations to prevent costs from being a barrier to patient access to Kinloch. So, you know, overall, we're very confident that, irrespective of generic suitant that, you know, pending intrigue, Kinloch really has a great opportunity to, again, transform the standard of Thank you. And I have one last question, a quick question for Tucker.

And then from a patient perspective, we will continue to do what we always do which is everything we're permitted to do with <unk>.

In line with relevant laws and regulations to prevent costs from being a barrier patient access to <unk>. So.

Overall, we're very confident that irrespective of generic student debt.

Pending and treat Kinloch really has a great opportunity to.

Again transformed standard of care.

Thank you and I have a last quick question quick question Tucker. So do you anticipate approval in China.

Eun Kyung Yang: So as you anticipate approval in China, would you actually book that approval milestone at once since, you know, the first or second quarter of this year? Sure, thanks for the question.

Wait.

Or would you actually book debt milestone at one thing.

First on the second quarter over this year.

Sure. Thanks for the question.

Thomas Patrick Kelly: Yeah, thanks for the question. So, I think what we've heard from Xi and from their public disclosures, they're expecting a potential regulatory decision in the first half. We have not provided any breakdown of the additional clinical or pre-approval milestones that we have under the collaboration agreement.

Thanks, Yes, thanks for the question.

So I think what we've heard from design their public disclosures they were expecting a potential regulatory decision in the first half.

We have not provided any breakdown of the additional clinical.

Pre approval milestones that we have under the collaboration agreement, but in the past certainly when we have had milestone to the pit.

Thomas Patrick Kelly: But in the past, certainly, when we have had milestones that have been achieved, we typically book those in the quarter in which they were achieved. Thank you. Thank you. Our next question will come from Andrew Berens from SVDLinux. You may begin. Hi, thanks. Congratulations on the quarter.

Typically book those in the quarter on which they were achieved.

Yeah.

Thank you. Our next question on come from the line of Andrew Burns from SVP Leerink.

You may begin.

Hi, Thanks, congrats on the quarter.

Andrew Scott Berens: I also have a question regarding your comments regarding persistency going forward. Since there's nothing approved in the fifth line, are you seeing patients come off of therapy because they're going on something else, or are they dying? Or are patients staying on therapy beyond progression?

I also have a question on your comments regarding the persistency going forward.

Since there is nothing approved on the fifth line are you seeing patients come off of therapy, because they are going on something else or are they die.

Or are patients staying on therapy beyond progression, then I have a follow up on the <unk> inhibitor.

Daniel C. Martin: Then I have a follow-up on the old inhibitor. Yeah, thanks, Andy. Dan, do you want to take this? Sure. Thanks, Andy. So, as we said recently, it's just a little early to be able to provide color on what we're seeing with persistency. I think we've been, what, just over two months, sorry, two quarters now.

Yes, Thanks, Andy Dan you want to take that.

Sure. Thanks, Andy So as we said recently.

It's just a little early to be able to provide color on what we're seeing with persistency.

I think we have been just over two months sorry, two quarters now and so the data that we have to evaluate that is still maturing and.

Daniel C. Martin: And so, you know, the data that we have to evaluate that is still maturing. And, you know, we've said we understand how important that is to everyone's models and certainly intend to bring some, bring forward some additional color when we have it.

We've said, we understand how important that is to everyone's models and certainly intend to bring some strength.

Bring forward some additional color.

We have it.

Daniel C. Martin: So, as you know, I started talking a bit more in terms of persistency late as opposed to, you know, average duration of therapy because, you know, persistency, as you know, is the percentage of patients that remain on therapy. Over time, and you know, with any product, some patients come off early, and some patients stay on for, you know, an extended period. So we'll just have to see how all that shakes out in the real world setting given the factors I mentioned before, you know, including mix by line of therapy and patient performance status and some non-clinical considerations, all of that.

So as you know I've started talking a bit more in terms of persistency of late as opposed to average duration of therapy, because persistency. As you know is the percentage of patients that remain on therapy.

Overtime.

And.

With any product some patients come on early in some patients stay on for an extended period. So we'll just have to see.

How all that shakes out in a real world setting given the factors I mentioned before.

Including mixed by line of therapy, and patient performance status and some non clinical considerations all of that so.

Daniel C. Martin: So more to come, as we feel like that data is sort of sufficiently ready for. Okay, but aside from the BID option, are some patients staying on longer, even after they progress? You know, that's hard to know because what we see on our side is just whether or not the patient's getting the product. What we don't see on our side when there is a physician determination of progression.

More to come as we feel like we.

On that data is sort of sufficiently ready for prime time.

Okay, but aside from the B I D.

<unk> on.

Some patients staying on longer even after they progress.

That's hard to know because what we see from from our side is just whether or not the patients getting the product what we don't see from our side when there is a physician.

Daniel C. Martin: So that's just really hard for me to answer, and like I said, we'll bring forward additional color on how long patients are staying on therapy as that data matures. Okay. And then on the all-conhibitor, I was just wondering, are there any concerns about the impact of the drug in the CNS, where autophagy is an important part of amino acid homeostasis? I know you guys had that special investor event. I just don't remember whether the drug crosses the blood-brain barrier and if that's a concern or not.

The determination of progression so.

On.

That's just really hard for me to answer.

Like I said well preparing for additional color on.

How long patients are staying on therapy as that data matures.

Okay and then on on the all competitor I was just wondering are there any concerns about.

The impact of the drug in the CNS, where auto is an important part of immuno acid homeostasis. I know you guys had that special investor, but I, just don't remember whether drug crosses the blood brain barrier.

Matthew L. Sherman: Yeah, thanks, Danny. It's a great question. Matt, do you want to take that? Yes, yeah, thanks, Andy, for the question. So yeah, no, we do not have concerns that the drug was designed to be a potent selective inhibitor of alkindase but to avoid CNS exposure.

That is a concern or not.

Yeah. Thanks, Dan It's a great question Matthew on it like that.

Yes, no. Thanks, Andrew for the question. So yes, no. We don't have we do not concern. So this drug is designed to be a potent selective inhibitor of <unk>, but to avoid CNS exposure. So we look forward to getting the phase one studies.

Matthew L. Sherman: So we look forward to beginning the phase one study. Okay, thanks a lot. I appreciate it.

Okay. Thanks, a lot per share it.

Peter Richard Lawson: And our next question comes from Peter Lawson from Barclays. You may begin. Thank you. Can I ask a question for Dan? Just any sense of the kind of off-label use or the degree of off-label use in GIST?

And our next question on quick ROI.

Awesome.

Barclays you may begin.

Thank you thanks for taking the questions.

Maybe a question for Dan just to.

On a sense of kind.

Kind of off label use on the degree of off label use in gist.

Peter Richard Lawson: Sure, thanks. Do you mean with Kinloch or generally? Um, with Kinloch, please.

Sure. Thanks.

You mean with kinloch or generally.

We can look please.

Daniel C. Martin: Yeah, so as we've shared previously, the data that is available to assess use by line of therapy is limited, and it has challenges with it. So, you know, we do our best to triangulate that and estimate that, but it's definitely imperfect data. And, you know, what we've said is that a significant majority of the use we believe, we're confident is fourth line, consistent with our indication, which is, of course, the only way we promote Kinloch.

So.

As we've shared previously that the data that is available to assess use by line of therapy is limited it's got challenges with it so.

Do our best to triangulate that on an estimate that but.

It's definitely imperfect data.

And what we've said is that a significant majority of the use we believe.

We're confident is fourth line consistent with our indication.

Which is of course, the only way we promote kinloch, we've said that there has been some earlier line use but.

Daniel C. Martin: We've said that there has been some earlier line use, but the significant majority has been fourth line, consistent with our Gotcha, thank you. And then the oak inhibitor, so 3-1-1-6, when can we see the initial data from that? So I guess that's for Matt.

The significant majority has been fourth line consistent with our indication.

Thank you and then the.

<unk> inhibitors with <unk>.

We see the initial data from that.

So I guess that's for met.

Peter Richard Lawson: Yeah, hi Peter, it's Steve. So I'll take that. It's a good question. So, as Matt mentioned a little bit earlier and as we've talked about previously, we don't expect to see monotherapy activity with the old inhibitors. So really, what we're trying to drive to as quickly as we can is to get into the combination portion of the study that Matt described in his prepared remarks. But we don't have specific guidance as to when we might be able to report data. It certainly won't be this year in 2021.

Yeah, Hey, Peter it's Steve So I'll take that it's a good question. So as Matt mentioned, a little bit earlier on as we've talked about previously we don't expect to see monotherapy activity with the old inhibitor. So really what we're trying to drive to as quickly as we can as you get into the combination portion of the study that Matt described in his prepared remarks. So we don't have specific guidance is.

When we might be able to report data.

It won't be this year in 2021, but as we have visibility to what the potential timing might be we'll of course update investors at that time.

Steven L. Hoerter: But as we have visibility into what the potential timing might be, we'll, of course, update investors at that time. Great. Thank you so much.

Great. Thanks, so much thanks for taking the questions.

Reni John Benjamin: Thank you. And I'll hand the call back over to Steve to get his, oh, I'm sorry about that. Our next question or call will be from the line of Ren Benjamin from J&P Securities. We may begin. Hey, good afternoon, guys.

Yes.

Thanks, Dan.

Yeah.

And now I'll hand, the call back over to Steve.

Oh, sorry about that our next question on the call will be from the line of Ren Benjamin with JMP Securities.

You may begin.

Daniel C. Martin: Thanks for taking the questions and congratulations on the quarter. Maybe just in terms of market penetration, can you maybe just give us a sense, do you have an idea as to how much of the fourth line market you guys have penetrated? I guess I'm trying to get a sense of whether it was so rapid that it was pretty steep, and we're kind of, you know, the future growth moderating is more because we're getting closer to a plateau or it's, you know, we came up sort of steep, but then, you know, we still have a decent way to go, at least in the fourth line. And then I just.

Hey, good afternoon, guys. Thanks for taking the questions and congratulations on the quarter.

Maybe just in terms of market penetration can you maybe just give us a sense do you have an idea as to how much of the fourth line market you guys have penetrated I guess I'm trying to get a sense of was it. So rapid that it was it was pretty steep and where kind of the future growth moderating as more because we're getting closer to plateau or.

We came up sort of feet, but then we still got a decent way to go at least in fourth line and then it yourself a follow up.

Yes, Brian It's a good question, Dan do you want to take that.

Sure. Thanks, Ron I think you are.

Daniel C. Martin: Yeah, that's a good question. Dan, do you want to take that? Sure. Thanks, Ren. I think you're The team has just done a fabulous job executing, despite the pandemic, and as a result, it's rapidly penetrated the fourth-line patient opportunity. You know, by any measure, we're...

The first interpretation is consistent with what.

We intend to communicate so.

The team is just on a fabulous job executing despite the pandemic and as a result.

Rapidly penetrated the fourth line patient opportunity.

By any measure were.

Pretty.

Daniel C. Martin: It's pretty clear that we've established Kinloch as the clear standard in the fourth line now across both academic and community settings. And so that's why, given that, we've communicated that we anticipate quarter-per-quarter growth to moderate until we're able to reach that next phase of significant growth, that being the second line pending approval.

It's pretty clear that we've established <unk> as the clear standard in fourth line now across both academic and community settings, and so that's why.

Given that that's why we've communicated that we anticipate.

Quarter over quarter growth to moderate.

Until we are able to reach that next phase of significant growth that.

Being in the second line setting pending approval.

Steven L. Hoerter: Yep, that makes sense. And I know I've asked this before, but I just want to know if there's any new thinking behind the European launch. You know, from my notes, it's a staggered launch, it's likely going to be, you know, your end weighted in terms of hiring the sales force and the like. Is that still the case, Steve?

Got it that makes sense and just I know I've asked this before I just wanted to know if there's any new thinking behind the European launch.

From my notes, it's a staggered launch it's likely going to be.

And weighted in terms of hiring the sales force and the like is that still the case, Steve or is there more of an active BD effort going on and have things changed in here when you're thinking as the application has been validated.

Steven L. Hoerter: Or is there more of an active BD effort going on? Have things changed in your thinking as the application has been validated? Yeah, so it's a great question, Ren. As you point out, the MAA has been validated by EMA. That occurred last year.

Yes, it's a great question on so as you point out the MAA has been validated by EMA that occurred last year and so we're targeting the second half of this year. That's when we believe that the European Medicines agency could take action on the application. We also announced today that we've now higher debt Margaret into RSA as senior Vice President.

Steven L. Hoerter: And so we're targeting the second half of this year. That's when we believe that the European Medicines Agency could take action on the application. We also announced today that we've now hired Margarida Duarte as Senior Vice President International and Head of International.

International head of head of international and she is going to now be taking on the role of building.

Steven L. Hoerter: And she is now going to be taking on the role of building the NIMBLE organization that we're hiring in Europe to be ready for a potential launch across that territory. I think it's important to note, and you alluded to this, Ren, that the launch will, of course, be staggered just by virtue of the fact that we have to wait for pricing and reimbursement negotiations to be completed in each and every country where we anticipate launching or introducing the drug.

Nimble organization that we're hiring in Europe to be ready for a potential launch across that territory. I think it's important to note and you alluded to this round that the launch will of course be staggered debt just by virtue of the fact that we have to wait for pricing and reimbursement negotiations to be completed in each and every country, where we anticipate.

<unk> launching or introducing the drug so the territory, where we would expect to be launching first is likely to be Germany, where we don't have to go through.

Steven L. Hoerter: So the territory where we would expect to be launching first is likely to be Germany, where we don't have to go through pricing and reimbursement negotiations, at least initially. But then for the rest of the territories, if you take Southern Europe, for example, Spain and Italy, we would expect the hiring associated with those territories, as well as the launch, to come at some point later. It could be 12 to 18 months after approval, just depending on the pace of those negotiations with the authorities. And if you'd just let me sneak one in for Tucker.

Pricing and reimbursement negotiations at least initially but then for the rest of the territories. If you say southern Europe for example, Spain and Italy, we would expect the hiring associated with those territories as well as the launch to come at some point later typically 12 months to 18 months after approval just depending on the pace of those negotiations with the authorities.

Got it and if you let me sneak one in for Tucker.

Thomas Patrick Kelly: The inventory, you know, we keep talking about COGS and how it's immaterial until the inventory is used up. When do you think that inventory will be used up? And can you just remind us where the COGS should go?

The inventory.

Inventory.

Keep talking about Cogs on how it's immaterial on.

Until the inventories used up when do you think that inventory will be used up and can you just remind us what the Cogs should go to.

Thomas Patrick Kelly: Yeah, thanks for answering the question. We haven't provided any long-term guidance on what we think the cost of goods will be for Kinloch. What we have said is what we've repeated today, which is that for the moment, it remains a material and that we think for the balance of the year of 2021 that it should remain at a very low level. So, not this year, and stay tuned; we'll try and update you as we get more understanding about when we'll have a higher cost of goods for the product.

Yeah. Thanks to answer the question. So we haven't provided any long term guidance on what we think the cost of goods will be four cannot.

We have said is when we competed today, which is that for the moment remains material and that we think for the balance of the year of 2021 that it should remain at a very low level. So not this year and stay tuned we'll try and update you as we get more understanding about when we will have a larger cost of goods for the product.

Reni John Benjamin: Terrific. Thank you very much. Thank you. And our last question will come from Robin Karnaskas from CHOOS. You may begin. Hi guys.

Terrific. Thank you very much.

Thank you and our last question on pump on the line of Robyn on assets.

And choice.

Hey, guys, Hey, guys. Thanks again for taking my question and congratulations on the on the on the all the hard work on the launch so two questions. One first on maybe a silly one so as you've continued to touch more doctors in the community setting in the academic setting and you talked to them about the treatment of Gist have you got any.

Robin Karnaskas: Thanks again for taking my question and congratulations on all the hard work on the launch. So two questions. This one, first one, may be a silly one.

Steven L. Hoerter: So as you've continued to touch more doctors in the community setting and the academic setting, and you talked to them about the treatment of just, have you got any supportive or anecdotal data points to support a suit and second line PFS of around five to six months? So is it supportive? Does anything anecdotal would be helpful as you're talking to doctors?

Supportive or anecdotal data points that support our suite in second line PFS of around five to six months is it supportive just anything anecdotal would be helpful. As youre talking to doctors and the second question on 316.

Steven L. Hoerter: And the second question on 3116: So, Amgen, obviously, their KRFs could be approved very shortly, and there's a lot of oncology designs lately that have been adaptive trial designs, quick paths to market, quickly being able to see what kind of combinations work best. Have you thought about exploring any adaptive trial design for 3116, given the space is very competitive and there could be certain combinations that work best? So let me take the first question and then I'll ask Matt if he'd like to take the second question about 3116 and then your question about combinations or adaptive trial designs going forward.

So amgen, obviously, there could be approved very shortly.

And there's a lot of oncology designs look they've been adaptive trial designs quickly quick path to market quick quickly being able to see what kind of accommodations work fast.

Have you thought about exploring and in any.

And adaptive trial design for 316, given the space is very competitive and there could be certain combinations combinations that work best.

Thanks.

Yeah. Thanks, Rob on a C. So let me take the first question and then I'll ask Scott, Matt if he'd like to take the second question about 311, 6% on your question about.

Combinations or adaptive trial designs going forward. So first with respect to what we would expect to see from Sue said and nothing has really changed on that front. So you know as you know in the label the PFS for <unk> on the second line is at five six months and we when we were designing and <unk> spent a lot of time with investigators and thought leaders trying to understand what the best estimate was to use.

Steven L. Hoerter: So first, with respect to what we would expect to see from SUTENT, nothing has really changed on that front. So as you know, in the label, the PFS for SUTENT on the second line is at 5.6 months.

Steven L. Hoerter: And we, when we were designing Intrigues, spent a lot of time with investigators and thought leaders trying to understand what the best estimate was to use for SUTENT's PFS in the second line setting. And all of those thought leaders and investigators agreed that six months was the right estimate to use. So we haven't learned anything new on that front, certainly not from anecdotal conversations with individual physicians that would change our view that six months is the right estimate to use.

For <unk>.

Such as PFS in the second line setting and all of those thought leaders and investigators all coalesced around six months as being the right estimate to use so we haven't learned anything new on that front certainly not some anecdotal comments on conversations with individual physicians that would change our view that six months is the right estimate to use and that was the basis for.

Steven L. Hoerter: And that was the basis for our design of the Intrigues study. So Matt, do you want to take the second part of that question about 3116? Yes, you know, so thanks, Robin. It's a really good question.

Our design then of the intrigue study so Matt do you want to take the second part of that question about 30 on 16.

Yes.

Thanks, Robin it's a really good question and.

Matthew L. Sherman: And, you know, first, to start off, we're going to combine 3116 with an inhibitor preventative and inhibitor of the MAP kinase pathway. And, you know, we look forward to evaluating the data. And, you know, we'll be able to, you know, make a determination whether or not then how fast we move forward to registration. And, you know, certainly using a novel, you know, adaptive design gives companies the ability to just expand current cohorts of patients, perhaps if they see a high level of activity.

So first to start off we're going to combine 2016 with an inhibitor tremendous.

The map kinase pathway.

We look forward to evaluating the data.

We will be able to because of termination whether or not to move.

How fast to move forward to two registration.

Certainly using a novel adaptive design.

Coming into the ability to just expand on your current.

Cohorts of patients, perhaps if we see a high level of activity and that's the data that could be per quarter to regulatory authorities, but in addition to that there may be other compensation partners.

Matthew L. Sherman: And that's the data that could be brought forward to regulatory authorities. But in addition, there may be other combination partners that 3116 can be combined with, and we've started to generate some of that data as well, too. So it could go beyond the MAP kinase pathway in combination.

Because it can be combined with whom we have started to generate some of that data as well too. So it could go beyond the map kinase pathway.

On competition.

Robin Karnaskas: I love it. All right. Thank you. Thank you, and I'm not asking any further questions at this time. I'm going to come back over to Steve to give any closing remarks. Okay. Thanks, Victor. Thanks to all of you for joining us on this afternoon's call and for your continued support of Deciphera. We look forward to keeping you all updated on our continued progress, not only with the Kinloch launch but also as the balance of our development programs really comes into focus this year and we provide some meaningful further data updates. I hope you all have a great evening. Thanks again. Ladies and gentlemen, this concludes today's conference call. Thank you for participating!

Alright, thank you.

Thank you and I'm not showing any further questions at this time.

On a cut back over to Steve to give any closing remarks.

Great. Thanks, Victor and thanks to all of you for joining us on this afternoon's call and for your continued support of decipher. We look forward to keeping you all updated on our continued progress not only with the <unk> launch, but also as the balance of our development programs really come into focus this year and we'll provide some meaningful further data updates I hope you all have a trading day.

Thanks again.

Yes.

Okay.

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

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