Q3 2019 Earnings Call

Good day, everyone and welcome to decipher Pharmaceuticals third quarter 219, the financial results Conference call.

Operator: and welcome to the Deciphera Pharmaceuticals third quarter 2019 financial results conference call. Today's call is being recorded. At this time, I would like to turn the call over to Jen Robinson, Vice President, Investor Relations.

Today's call is being recorded.

At this time I would like to turn the call over to Chetan Robertson, Vice President Investor Relations Jim.

Jennifer Larson: Thank you, Blue. Welcome, and thank you to those of you joining us today to discuss Deciphera's third quarter 2019 financial results. I'm Jen Robinson, Vice President, Investor Relations at Deciphera. With me this afternoon to discuss the quarter's results and provide a general corporate update are Steve Hoerter, President and Chief Executive 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 include the status of, and our expected timelines for, our preclinical and clinical studies and preparations for a potential NDA submission.

Thank you Bill welcome and thank you for those of you joining us today to discuss the Cyprus third quarter 2019 financial result, I'm generally it sends vice President Investor Relations at the Cyprus with me. This afternoon to discuss the quarter's results and provide a general corporate update Steve hurt, our president and Chief Executive Office.

They're not Sherman Chief Medical Officer, and Tegra, 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 safe Harbor provisions of the private securities.

Integration Reform Act of 1995 examples of forward looking statements made during this conference call include the status of and are expected timeline spore our preclinical and clinical studies and preparations for a potential ideate submission forward looking statements made on this call involve substantial risks and uncertainties that could cause act.

Jennifer Larson: 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 the execution of clinical trials, the timing of data, the actions of regulatory agencies, and those set forth in our most recent quarterly report on Form 10-Q, as well as in our other SEC filings. We assume no obligation to update or revise any forward-looking statements.

Well 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 the execution of clinical trials, the timing of data actually the regulatory agencies and those set forth in our most recent quarterly report on Form 10-Q , as well as our other SEC filings, we assume no obligation to update or revise any forward looking statements. Following this call a replay will be available on the company's website.

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.

W.W. Dot decipher dotcom would that I will now turn the call over to Steve harder, President and Chief <unk>, Chief Executive Officer of Decipher Steve.

Steven L. Hoerter: Thank you, Jen, and good afternoon to everyone who's listening on the call and joining via the webcast. I'd like to welcome all of you to our first conference call to provide a general corporate update and financial results.

Research and good afternoon to everyone who's listening on the call on joining via the webcast I'd like to welcome all of you to our first conference call to provide a general corporate update and financial results. We've made significant progress across the entire pipeline over the last quarter.

Steven L. Hoerter: We have made significant progress across the entire pipeline over the last quarter. Most importantly, we announced positive results from our Invictus Pivotal Phase 3 study of Repretniv for the treatment of advanced gastrointestinal stromal tumors, or GIST. These data mark a transformative milestone for Deciphera, representing our first registration-enabling dataset and importantly, strong clinical validation of our proprietary kinase switch control inhibitor platform and the potential for our product candidates to improve the lives of people with cancer. For people living with GIST whose disease has progressed after treatment with the currently approved drugs, there is an urgent unmet need for new therapies that can deliver effective disease control. We believe Repretinib has demonstrated the potential to transform the GIST treatment landscape and serve as an effective therapy for this heavily pre-treated patient population.

Most importantly, we announced positive results from our Invictus pivotal phase three study of or prednisone for the treatment of advanced gastrointestinal stromal tumors or just these data mark a transformative milestone for decide from representing our first registration, enabling dataset and importantly, strong clinical validation of our preferred.

Hi, Jerry kinase switch control inhibitor platform.

And the potential for our product candidates to improve the lives of people with cancer.

For people living with just whose disease has progressed after treatment with the currently approved drugs. There was an urgent unmet need for new therapies that can deliver effective disease control.

We believe reproductive has demonstrated the potential to transform the just treatment landscape and serve as an effective therapy for this heavily pre treated patient population.

Steven L. Hoerter: Today, we announce that the FDA has granted Repretinib breakthrough therapy designation for the treatment of patients with advanced GIST who have received prior treatment with imatinib, sunitinib, and regorafinib. We look forward to our continued, very collaborative dialogue with the agency as we work toward our submission of a new drug application, or NDA, for Repretinib, which we continue to expect to submit in the first quarter of As we ready ourselves for the potential transition from a development stage to a commercial stage company, we are focused on building out our commercial and medical affairs capability. We are committed to ensuring that we are well positioned to support the planned launch of Repretnib in the United States, if approved, and we look forward to updating you on these efforts in the coming months. Beyond RepreTinib, we have a diverse and exciting pipeline of wholly owned oral product candidates spanning all stages of development, all generated from our proprietary kinase switch control inhibitor platform. These include DCC 3014, Ribacinib, and DCC 3116.

Today, we announced that the FDA has granted we're prednisone breakthrough therapy designation for the treatment of patients with advanced just to have received prior treatment with a madness sunitinib and regular Avenue.

We look forward to our continued very collaborative dialogue with the agency as we work toward our submission of a new drug application or end D.A. for reporting to which we continue to expect to submit and the first quarter of 2020.

As we ready ourselves for the potential transition from a development stage two a commercial stage company. We are focused on building out our commercial and medical affairs capabilities. We are committed to ensuring that we're well positioned to support the plan to launch of reprinting I've been the United States, If approved and we look forward to updating you on news.

Efforts in the coming much.

Beyond reporting that we have a diverse and exciting pipeline of wholly owned oral product candidates spanning all stages of development and all generated from our proprietary kinase switch control inhibitor platform.

These include DCC at 30, 14, where bassinet and DCC 30 116.

Steven L. Hoerter: At the AACR-NCI-EURTC, or so-called triple meeting, last week in Boston, we presented updated data from all of our pipeline programs. To review these programs in greater detail, I'd now like to introduce Matt Sherman, our recently appointed Chief Medical Officer. Matt brings over 25 years of experience as a physician scientist in clinical drug development in oncology and hematology, most recently as chief medical officer of Acceleron. In just a short period of time, Matt has already made important contributions to Deciphera, and I look forward to working alongside him and the rest of the team here as we advance our pipeline. I'll now turn the call over to Matt for an overview of recent program updates. Okay, Matt?

At the a CR and see I you are T. C. Four so called Triple meeting last week in Boston, We presented updated data from all of our pipeline programs.

To review these programs in greater detail I'd now like to introduce Matt Sherman, Our recently appointed Chief Medical Officer.

Matt brings over 25 years of experience as a physician scientists and clinical drug development in oncology and hematology. Most recently as Chief Medical Officer of Acceleron [laughter] and just a short period of time, Matt has already made important contributions to decide for and I look forward to working alongside him and the.

Rest of the team here as we advance our pipeline.

I'll now turn the call over to Matt for an overview of recent program updates Matt.

Matthew L. Sherman: Thank you, Steve. It is truly an honor to have joined Deciphera at this exciting time. Deciphera's proprietary kinase switch control platform has generated a robust pipeline of novel kinase inhibitors spanning late stage to preclinical development, all of which are designed to address unmet need in difficult-to-treat cancer. I am grateful for the opportunity to help advance and shape these programs to deliver much needed novel therapies to patients and look forward to working alongside such a deeply knowledgeable and impressive team. I would now like to give an overview and provide an update on our pipeline program starting with repertinib. Before we get into the data, it is important to put the GIST population into perspective.

Thank you Steve this truly im honored to have joined to say front. This exciting time to surfers proprietary Tinyswitch control platform has generated a robust pipeline of novel kinase inhibitors spending late stage to preclinical development all of which are designed to address unmet need and difficult to treat cancers.

I am grateful for the opportunity to help advance in shape. These programs to deliver much needed novel therapies to patients and look forward to working alongside such a deeply knowledgeable and impressive team.

I would not only to give an overview and provide an update on our pipeline programs starting with were pregnant.

Before we get into the data it is important to puts it just population into perspective.

Matthew L. Sherman: Kid mutations comprise approximately 8% of both primary and secondary mutations. An estimated 4,000 to 6,000 new patients are diagnosed with GIST in the U.S. each year, the majority of which receive imatinib in the front-line setting. Existence develops which is generally due to the emergence of secondary mutations in the KIT gene.

Good mutations comprised approximately 8% to both primary and secondary mutations an estimated 4000 to 6000, new patients are diagnosed with just in the U.S. each year.

Majority of which received a magnet from the frontline setting.

Justin develops which is generally due to the emergence of secondary mutations in the kitchen.

Matthew L. Sherman: After imatinib, patients move to treatment with sunitinib in the second line and regirafinib in the third line setting. There are currently no approved treatments for patients who have received prior treatment with these three drugs. We believe the repretinib data from the INVICTUS study and the ongoing Phase 1 study demonstrate the potential for repretinib to transform the post-imatinib treatment landscape. The INVICTUS study achieved its primary endpoint of improved progression-free survival, or PFS, with a median PFS of 6.3 months in the reprudent arm compared to one month in the placebo arm, with a p-value of The precaution significantly reduced the risk of disease progression or death by 85%, with a hazard ratio of 0.15.

After a mountain to patients moved to treatment with Sumit and open the second line and Rick Rick a rough in that in the third line setting.

There are currently no approved therapies for patients who have received prior treatment with these three drugs.

We believe the recruitment data from Invictus study and the ongoing phase one study demonstrates potential for pacritinib to transform the post a mountain of treatment landscape.

The Invictus study achieved its primary endpoint of improved progression free survival or PFS with a median PFS of 6.3 months ago, putting them from compared to one month in the placebo arm with a P value of less than 0.0001.

The prison significantly reduce the risk of disease progression for desk, but 85% with a hazard ratio of 0.1 funds.

Matthew L. Sherman: For the key secondary endpoint of objective response rate, or ORR, where peritonib showed a rate of 9.4% compared with 0% for placebo, with a p-value of 0.0504, which was not statistically significant. Dr. Pritnip also showed a clinically meaningful improvement in overall survival, or OS, versus placebo, with a median OS of 15.1 months versus 6.6 months for placebo, OS was not formally tested due to the hierarchy of the statistical plan.

With a key secondary endpoint objective response rate or our reported never shows for rate of 9.4% compared with zero percent for placebo with a P value of 0.050 for which was not statistically significant.

We are putting that also showed a clinically meaningful improvement of overall survival are all else versus placebo. The median all was 15.1 months versus 6.6 months for placebo hazard ratio 0.36, and nominal P value 0.000 for.

Oh, it was not formally tested to the hierarchy of the statistical plan.

Matthew L. Sherman: Additionally, repertinib was generally well-tolerated, and the adverse events in the infectious This study were consistent with data from previously presented Phase I results. Grade 3 or 4 treatment-emergent adverse events in greater than 5% of patients in the repertorative arm were anemia, abdominal pain, and hypertension, and in the placebo arm, anemia. We believe these efficacy and safety data are highly impressive, particularly the magnitude of benefit observed for overall survival, and suggest that recruitment's approach of targeting the broad spectrum of mutations known to drive GIST can improve outcomes in the most heavily pretreated patients. We expect to submit an NDA to the FDA in the first quarter of 2020 for the treatment of patients with advanced GIST. We look forward to actively working with the agency on our goal to deliver this potential treatment option to patients.

Additionally, reporting that was generally well tolerated and the adverse events in Texas.

Study were consistent with data from previously presented phase one results.

Great three or four treatment emergent adverse events greater than 5% of patients and they're putting them arm were anemia, abdominal pain and hypertension, and then the placebo arm AMEA.

We believe these efficacy and safety data or highly impressive, particularly the magnitude of benefit observed for overall survival and suggests that recruitments approach of targeting the broad spectrum of mutations known to drive CIS can improve outcomes and the most heavily pretreated patients.

We expect to submitting an NDA to the FDA and the first quarter of 2020 for Britain for the treatment of patients with advanced just we look forward to actively working with the agency on our goal to deliver this potential treatment option to patients.

Matthew L. Sherman: Turning to the triple meeting that took place last week, we reported positive updated results from the ongoing phase one study of rupertinib in just patients, with a starting dose of 150 milligrams daily. We are very pleased with how the results have matured and with an additional five months of data across all lines of therapy and all measures of clinical activity as assessed by the investigators. In particular, I would like to highlight the data from the cohort of 31 patients with second-line GIST, which is the same patient population that is the subject of our ongoing second randomized phase 3 trial, Intrigue. The median PFS increase of 46 weeks confirmed ORR was 19% with a median duration of response of 80 weeks. As you will recall, published data from centrally-read pivotal trials for sunitinib, definitive care, and second-line GIST demonstrated a median PFS of 24.1 weeks and a confirmed ORR of 6.8%. In addition, the mean treatment duration, which includes patients that were just escalated, increased across all lines of treatment with the longest treatment duration of 142 weeks.

Turning to the Triple meeting that took place last week, we reported positive updated results from the ongoing phase one study of recruitment than just patients with the starting dose of 150 milligrams daily.

We're very pleased with how the results of matures and with an additional five months of data across all lines of therapy, and all measures of clinical activity as assessed by the investigator.

In particular I would like to highlight the data from a cohort 31 patients. The second line, just which is the same patient population does the subject of our ongoing second randomized phase three trial and treat.

Medium PFS increased to 46 weeks confirmed for our was 19% with a median duration of response of TV weeks.

As you will recall published data from sense, we read pivotal trials for some sunitinib. The standard of care in second line just demonstrated the median PFS is 24.1 weeks, we confirmed for our of 6.8%.

In addition, the need for prism treatment duration, which includes patients that were just escalated increase across all lines of treatment with the longest treatment duration of 142 weeks.

We're prudent was generally well tolerated and the updated adverse events were consistent with previously presented phase one data in patients with just.

Matthew L. Sherman: Pre-NIP was generally well-tolerated, and the updated adverse events were consistent with previously presented Phase I data in patients with JIP. Grade 3 or 4 treatment emergent adverse events occurred in more than 5% of patients and were an increase in lipase level, anemia, and abdominal pain. We believe these data, along with the Invictus data, continue to support the ongoing Intrigue Phase III Pivotal Study and Second Line GIST. We are making great progress activating sites and enrolling patients in this study. And we currently have 92 sites open in 18 countries.

Three or four treatment emergent adverse events more than 5% patients, where an increase my piece level anemia and abdominal pain.

We believe these data along with the Invictus data continue to support the ongoing and treat phase three pivotal study in second line just.

We're making great progress activating sites enrolling patients in this study and we currently have 92 sites open in 18 countries.

I'd like to spend some time now walking through our other programs beyond repetitive ingest first DCC 30, 14 is our early administered potent in highly selective inhibitor that the CSF one receptor assist with one or 30 14 was designed to selectively binds to the since that's one or so.

Matthew L. Sherman: I'd like to spend some time now walking through our other programs beyond reprinting of ingest. First, DCC3014 is our orally-administered, potent, and highly-selective inhibitor of the CSF1 receptor, or CSF1R. 3014 was designed to selectively bind to the CSF1R switch pocket and has a greater than 100-fold selectivity for CSF1R over closely-related kinases and has an even greater selectivity for CSF1R over approximately 300 other human kinases. 3014 is currently being evaluated in a multi-center, open-label Phase I clinical study in patients with advanced solid tumors, including patients with tenosy Our initial focus with 3014 is on TGCT. This disease is driven by a genetic mutation in certain cells within the tumor causing an overproduction of CSF-1, the ligand for CSF-1R. TGCT is a locally aggressive tumor of the synovium bursa or tendon sheath that has significant morbidity for patients.

[noise] pocket and has a greater than 100 folds activity for CSF. One are over the closer related client bases and has become even greater selectivity for sales of one are over approximately 300 other human kindness.

30, 14 is currently being evaluated the multicenter open label Phase one clinical study in patients with advanced solid tumors, including patients with tennis Inovio Giants kill tumors for TGC too.

Our initial focus with 30 14 is on TGC to.

This disease is driven by genetic mutation in certain cells within the tumor, causing an overproduction of CSF one.

Again consists of one or.

TGC T is a locally aggressive tumor this November so returns and she has significant morbidity for patients.

The only approved systemic therapy aspects exhausting the small molecule inhibitor assist with one or which was approved in August and is subject to a rems program due to Petro toxicity.

Matthew L. Sherman: The only approved systemic therapy is pexidartanib, a small molecule inhibitor of CSF1R, which was approved in August and is subject to a REMS program due to hepatitoxicity. We believe that 3014 has the potential to fulfill the unmet medical need for a more effective treatment with a favorable safety profile for TGCT patients. Last week at the triple meeting, we presented phase one data of 3014 from seven dose cohorts across 36 patients with advanced solid malignancy. The data demonstrated dose-proportional exposure for 3014 that was associated with an increase in plasma, CSF1, and IL-34 levels, a rapid and sustained reduction of CD16-positive monocytes in peripheral blood, and substantial decreases in CD163-positive macrophages in tumor. 3D14 has been generally well-tolerated, and most treatment-emergent adverse events were grade 1 or 2. The most common treatment-related adverse events greater than or equal to 10% were fatigue, diarrhea, and nausea. Three or four treatment-related adverse events occurred in four patients, which were an increase in AST, an increase in lipase, an increase in amylase, and colitis. However, there were no related serious adverse events.

We believe that 30 14 has potential to facility unmet medical need for a more effective treatment with a favorable safety cross profile for TGC t. patients.

Last week at the Triple meeting, we presented phase one data through the 14 from seven dose cohorts of course 36 patients with advanced solid malignancies.

The data demonstrated dose proportional exposure for 30 14, those associated with an increase in plasma CSF, one and oil 34 levels, a rapid and sustained reduction of city 16, causative monocytes and peripheral blood and substantial decreases and see the 163 positive macrophages in tumor.

The relief 14 has been generally well tolerated and most treatment emergent adverse events the grade one or two.

The most common treatment related adverse events greater than or equal to 10%, we're fatigue diarrhea inertia.

Three or four trillion related.

This events occurred and four patients, which were an increase in HST, an increase in white space and increase in families and Columbus, there were note related serious adverse events.

Dose escalation evaluation is ongoing to determine the recommended phase two dose for advanced solid tumors empties GCT. Currently we have not reached the maximum tolerated dose for 30 14.

Matthew L. Sherman: Dose escalation evaluation is ongoing to determine a recommended phase 2 dose for advanced solid tumors and GCT. Currently, we have not reached the maximum tolerated dose for 3014. We look forward to presenting preliminary Phase I data from a small group of initial TGCT patients at the upcoming Connective Tissue Oncology Society, or CTOS, annual meeting in Tokyo, Japan. Now, turning now to ribastinib, our potent small molecule designed to inhibit type 2 kinase-expressing macrophages, or TEMs. TEMs are known to promote tumor angiogenesis, invasiveness, metastasis, and immunotolerance.

We look forward to presenting preliminary phase one data from a small group of initial TGC t. patients at the upcoming connective tissue Oncologists society or see toss annual meeting in Tokyo, Japan.

Turning now to our destiny, our potent small molecule designed to inhibit tied to kindness expressing macrophages are tim's Tim's are known to promote tumor Andrew Genesis Invasiveness metastasis in immuno tolerance.

Matthew L. Sherman: Bassinib is currently being evaluated in a Phase 1b, 2 study in combination with Paclitaxel and also in a Phase 1b, 2 study in combination with Carboplatin. The Phase 1B-2 Study of Robastinib, The Phase 1B-2 study of ribasinib in combination with paclitaxel in patients with advanced and metastatic solid tumors is an open-label, multi-center study designed to evaluate safety, tolerability, and pharmacokinetics. Data reported that the triple meeting was from part one of the study, which enrolled 43 patients, including 24 patients from the ribacid and 50 milligram BID cohorts and 19 patients from the 100 milligram BID cohort. Exposure to ribacinib was dose proportional when given in combination with paclitaxel, meaning circulating angiopoietin 2 levels increased with exposure to higher doses of ribacinib, indicating TY2 inhibition.

The best and that is currently being evaluated in the phase one be two study in combination with Paclitaxel and also in the phase one be two study in combination with carbo platinum.

The phase one be two study of are best in that.

The phase when be two study for best maybe combination paclitaxel in patients with advanced or metastatic solid tumors is an open label Multicenter study designed to evaluate the safety Tolerability and pharmacokinetics.

The other reported that the Triple meeting was from part one of the study, which enrolled 43 patients, including 24 patients from the best of in 50 milligram COVID-19 patients from the 100 milligram VIP covert.

Exposure to redemption that was dose proportional than given in combination with paclitaxel and mean circulating injured poets in two levels increased with exposure to higher doses or definite indicating tied to condition.

Importantly, the phase one data demonstrated encouraging preliminary anti tumor activity in both dose cohorts with objective responses seen across a heavily pre treated patient population, including patients with prior exposure to paclitaxel.

Matthew L. Sherman: Importantly, the Phase 1 data demonstrated encouraging preliminary anti-tumor activity in both dose cohorts, with objective responses seen across the heavily pre-treated patient population, including patients with prior exposure to Paclitax. Most patients received more than three prior treatments, and the median number of prior therapies was 4.5. Confirmed and unconfirmed responses were seen in eight patients, including three ovarian, two breast, two carcinosarcoma, and one peritoneal mesothelioma. Five of these responses were in the 15mg BID dose cohort, and three were in the 100mg BID cohort.

Most patients received more than three prior treatments in the medium number prior therapies was 4.5.

Confirmed and unconfirmed responses were seeing an eight patients, including three or varian to breast two Carson those sarcoma and one parents Neal means affiliate.

Five of these responses were in the 15 milligram dose cohort three were in the 100 milligram cohort.

Matthew L. Sherman: 7 of these 8 responding patients had prior therapy with paclitaxel or docetaxel. Radastinib in combination with paclitaxel is generally well-tolerated with similar frequency of treatment for emergent adverse events in a two-dose cohort. Most treatment emergent adverse events were consistent with the first in human study of ribacinib and are known to be associated with paclitaxel treatment. Part two of this study is ongoing and is a Simon two-stage design with four expansion cohorts in triple negative breast cancer, inflammatory breast cancer, ovarian cancer, and endometrial cancer. The recommended phase 2 dose is 50 mg BID. We are encouraged by the early signs of activity in this study and look forward to providing additional updates in the future. Finally, earlier this year, we announced the addition of DCC3116 to our pipeline.

Seven of these eight responding patients at prior therapy with Paclitaxel warrant dosing texel.

Redefinition combination paclitaxel was generally well tolerated similar frequency of treatment emergent adverse events between the two dose cohorts.

Most treatment emergent adverse events were consistent with the first in human study of Ferguson that are known to be associated with Paclitaxel treatment.

Part two of this study is ongoing and his assignment to stage design for expansion cohorts and triple negative breast cancer inflammatory breast cancer ovarian cancer and the mutual cancer.

The recommended phase two doses 50 milligrams be I'd. We are encouraged by the early signs of activity in the study and look forward to providing additional updates in the future.

Finally earlier this year, we announced the addition of DCC 30, 116 to our pipeline 30 116 as potential first in class small molecule designed to inhibit inhibit autophagy by selectively targeting the Oct, one and two kind he says.

Matthew L. Sherman: 3116 is a potential first-in-class small molecule designed to inhibit autophagy by selectively targeting the ALK1 and 2 kinases. This family of kinases initiates autophagy and provides the potential for a targeted approach by selectively inhibiting autophagy in RAS mutant cancer. Autophagy is a cellular pathway that has been shown to be upregulated in mutant RAS cancers and mediates resistance to inhibitors of the RAS signaling pathway. Preclinical data presented last week at the triple meeting showed that 3116 is a potent, selective, and tight-binding inhibitor of the Olk kinase. Subject to favorable investigational new drug enabling studies and submission and activation of an IND application with submission expected in the middle of 2020, we intend to develop 3116 for the potential treatment of mutant RAS cancers in combination with MAP kinase inhibitors.

This family of kinase as initiate so tough Angie and provides the potential for targeted approach by selectively inhibiting a tough engine breast meat and cancers. The tougher GE is a cellular pathway that has been shown to be up regulated mutant breast cancers immediate resistance to inhibitors of the rest signaling pathway.

Preclinical data presented last week at the Triple meeting showed that 30 116, there's a potent selective and tight binding inhibitor of the folk kinds.

Subject to favorable investigational, new drug, enabling studies and submission and activation of the 90 application with submission expected in the middle of 2020, we intend to develop 30 116 with a potential treatment of new unrest cancers in combination with map kinase inhibitors.

In summary, we at the site for our excited to have an extensive pipeline of potentially paradigm shifting molecules spanning across various stages of development. While we're proud of the progress we've made with printing it as we near the expected NDS submission for the treatment of advanced just we remain focused on the opportunities that can 34.

Matthew L. Sherman: In summary, we at Decipher are excited to have an extensive pipeline of potentially paradigm-shifting molecules spanning across various stages of development. While we are proud of the progress we have made with reprintnib as we near the expected NDA submission for the treatment of advanced GIST, we remain focused on the opportunities at hand in 3014, rebastinib, and 3116, as well as other discovery programs that we have not yet disclosed. I will now turn the call over to you.

Team the best in the 30 116 as well as other discovery programs that we have not yet disclosed.

I will now turn the call over to Tucker to review the financial results from this quarter.

Thomas Patrick Kelly: Thanks Matt. Let me take just a minute to discuss a few highlights from our third quarter 2019 financial results. First, following the positive top-line results from Invictus, in August, we completed a very successful follow-on public offering that raised approximately $432 million in net proceeds, money which will help us fund our expected transition to a commercial company and support the continued development of our expanding pipeline of novel switch control inhibitors. With the net proceeds of the public offering, we had cash, cash equivalents, and marketable securities of approximately $635 million as of September 30, 2019, which we expect will be sufficient to fund our operations and CapEx requirements into 2020. In the third quarter of 2019, our total operating expenses were $58.4 million, an increase of $10.4 million from the second quarter of 2019. Research and Development Expenses were $40.4 million, and General and Administrative Expenses were $18 million for the third quarter. We expect our expenses to continue to grow over the coming quarters as we continue to build our commercial organization and expand our clinical development activities.

Thanks, Matt Let me take Testament to discuss a few highlights our third quarter 2019 financial results first following the positive topline results ridiculous in August we completed a very successful follow on public offering raised approximately $432 million net proceeds money, which will help us fund our expected transition to a commercial company and support to continue.

Development of our expanding.

Pipeline of novel switch control inhibitors.

The net proceeds of public offering we had cash cash equivalents in marketable securities approximately 635 million as of September Thirtyth, 2019, which we expect to be sufficient to fund our operations and capex requirements into 2022.

In the third quarter of 2019, our total operating expenses were 50.4 million an increase of 10.4 million from the second quarter 2019.

Research and development expenses were 40.4 million and general and administrative expenses were $18 million in the third quarter.

We expect our expenses to continue to grow over the coming quarters as we continue to build our commercial organization and expand our clinical development activities with that I'll now turn the call back over to Steve. Thank you soccer, we've made significant progress across the company and across the pipeline over the last few months and are preparing for what will be an exciting year ahead.

We remain on track to submit the repression of end da and the first quarter of next year for the treatment of patients with advanced just and we continue to dry forward with rapid site opening and patient enrollment for our intrigue study, where we're comparing represented two sunitinib and patients with just you've received prior treatment with the madness.

Steven L. Hoerter: Thank you, Tucker. We've made significant progress across the company and across the pipeline over the last few months and are preparing for what will be an exciting year ahead. We remain on track to submit the Repretnib NDA in the first quarter of next year for the treatment of patients with advanced GIST, and we continue to drive forward with rapid site opening and patient enrollment for our Intrigue Study, where we're comparing Repretnib to Sanitnib in patients with GIST who have received prior treatment with imatinib. The rest of our clinical stage pipeline is now coming into view, and Before opening the call for questions, I'd like to thank the patients, their caregivers, and the physicians who have participated in our clinical trials and the amazing team here at Deciphera for their hard work and dedication to making a difference for patients. With that, Operator, I'd like to open the call for questions.

The rest of our clinical stage pipeline is now coming into view and we look forward to advancing these programs and providing additional meaningful updates in the year ahead.

Before opening the call for questions I'd like to thank the patients their caregivers in the physicians, who have participated in our clinical trials and the amazing team here at the site for for their hard work and dedication to making a difference for patients with that operator I'd like to open the call for questions.

Thank you.

Ladies and gentlemen, if we have a question at this time. Please press. The Star then the number one on your touched on it also.

Sure question, that's been answered already wish to remove yourself from the Q. Please press the path.

Your first question comes from the line Jessica Fye from Jpmorgan. Your line is open.

Hey, guys. Good afternoon, thanks for taking my questions.

A couple first are there any remaining deliverables on them factoring side that are gating for the filing of for frightening and if so can you talk about what they are.

Operator: Thank you. Ladies and gentlemen, if you have a question at this time, please press the star, then the number one on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pad. Your first question comes from the line of Jessica Fye from J.P. Morgan. Your line is open.

And then second for Tucker you mentioned the at that could continue to grow.

Can you think it can you help us think about how do.

We had a project that kind of help us think about the magnitude of growth and assuming most of its R&D driven.

Jessica Fye: Uh, we just had a project that kind of helped us think about the magnitude of growth. I'm assuming most of it is R&D driven.

Yes, it's Steve I'll take the first part of the question and then turn it over to Tucker to address the other question that you asked if theres a lot of work ongoing across the company really as we prepare for the end da and that's really across each and every one of the modules, including CMC. So there's not anything specific that I would I would call out on C.

Steven L. Hoerter: Hey Jess, it's Steve. I'll take the first part of the question and then turn it over to Tucker to address the other question that you asked. You know, there's a lot of work ongoing across the company, really, as we prepare for the NDA, and that's really across each and every one of the modules, including CMC. So there's not anything specific that I would call out on CMC that would stick out as a gating item. There's really work across all of the modules that the team is preparing for that filing to go in during Q1 of 2020.

M.C.

That would stick out as a gating item has really work across all of the modules that the team is preparing for that filing to go and Q1 of 2020.

Sure Jeff Tucker on the financial side, when I say is that the third quarter. Obviously included both the.

Completion of Invictus as well as the ramping up on entry was larger study than and Invicta. So those clinical costs will carryover, particularly on entry into the next few quarters in 2020 as well as the continued development of the other pipeline.

Thomas Patrick Kelly: Sure, Justice Tucker, on the financial side, what I'd say is that the third quarter obviously included both the completion of Invictus and the ramping up on Intrigue, which is a larger study than Invictus. So those clinical costs will carry over, particularly on Intrigue, into the next few quarters in 2020, as well as the continued development of the other pipeline assets. So Rabast Inhibit 3014 will have increased expenses, particularly with Rabast as we move through Part 1 and into Part 2 of those combination studies with Paclitaxin and Carboplatin. So you're right that a lot of the increase in spend going forward will be on the R&D side. In addition, we are scaling up to meet the potential commercial requirements of having a sales force and commercial infrastructure, so those will hit on the G&A side and will be judicious but ready in terms of hiring a sales force at the appropriate time.

And so were backed into the 30 14.

Increase expenses, particularly with the basket of as we move through part one and as a part two of those combination studies with Paclitaxel in public cloud and so you're right that a lot of the increase in spend going forward will be on the R&D side. In addition, we are scaling up to meet the potential commercial requirements of having a sales.

Of course.

Infrastructure. So those will hit on the DNA side and will be judicious, but ready in terms of hiring salesforce at the property of time.

Okay, Great and then just last one on the expanded access program and will that be open to patients who have seen.

Any number of prior therapies for just or just those who've seen pre three prior lines of therapy and I'm wondering if you can talk about how many centers you plan to include in the expanded access.

Steven L. Hoerter: Okay, great. And then just the last one on the expanded access program. Will that be open to patients who have seen any number of prior therapies for GIST, or just those who have seen three prior lines of therapy? And I'm wondering if you can talk about how many centers you plan to include in the expanded access program.

Yes. Thanks, just for the question on the EAP. So we're excited to ticket that open. So we expect that will have.

Over 150 patients globally on that EAP. That's that's what we're planning for in terms of sites, we would expect in the U.S. somewhere in the range of 20 sites and we're planning on globally around 20 over 20 different countries that would participate in that EAP in terms of eligibility for the.

Steven L. Hoerter: Yeah, thanks, Jess, for the question on the EAP. We're excited to get that open. So we expect that we'll have over 150 patients globally on that EAP. That's what we're planning for. In terms of sites, we would expect in the U.S., somewhere in the range of 20 sites, and we're planning on globally around 20, over 20 different countries that would participate in that EAP. In terms of eligibility for the EAP, patients, of course, need to have locally advanced unrespectable or metastatic GIST and have received prior treatment with at least two prior FDA-approved therapies.

He patients.

Course need to have been locally advanced unresectable or or metastatic Jess and have received prior treatment with at least two prior FDA approved therapies.

Great. Thank you.

Your next question comes from the line, Chris Raymond from Piper Jaffray. Your line is open.

Hey, thanks.

Clarify on.

Jessica Fye: Great, thank you.

One of the questions that you just answered from the last question question, but just on.

Christopher Joseph Raymond: Your next question comes from the line of Chris Raymond from Piper Jaffray.

Christopher Joseph Raymond: Hey, thanks. I just want to clarify on one of the questions that you just answered from the last questioner, but just on On breakthrough designation status for a ProdNib, so I think I heard you say, Steve, that you're going to submit all the modules at the same time, so I think last time I heard you guys talking about it, there was an option for doing a rolling submission, so should we assume that you're not going to do that, that it'll be a regular submission?

Right.

On breakthrough designation status or accretive.

So I think I heard you say, Steve that you're going to submit all the modules at the same types. So that I think last time I heard you guys talking about it there was an option for doing the rolling submission. So should we assume that that's the you're not going to do that it'll be a regular submission.

Yeah, Chris So thanks for the question, so you're right with fast track designation, which we disclosed earlier in the year that provided us with an option of initiating a rolling submission and so on the on the call today, we're not changing our guidance are providing any additional color around that will work with the FDA now with breakthrough therapy designation for.

Steven L. Hoerter: Yeah, hi Chris, so thanks for the question. So you're right, with the FastTrack designation, which we disclosed earlier in the year, that provided us with an option of initiating a rolling submission. And so on the call today, we're not changing our guidance or providing any additional color around that. You know, we will work with the FDA now on breakthrough therapy designation for PretNib to get the file in as expeditiously as possible. And our guidance remains that we will have that file completed in quarter one of 2020.

Right now to get the file land as expeditiously as possible and our guidance remains that we would have that file completed in quarter one of 2020.

Okay. So it could still be a rolling submission is that correct.

Yes, we're not providing any any further detailed in terms of whether it would be a rolling submission or not a rolling submission.

Got it Okay and then.

Just.

And on the intrigue study so.

Steven L. Hoerter: Oh, okay, so it could still be a rolling submission, is that correct?

You know, we just recently learned that.

Your competitor you know ever printed second line Compass trial was pushed back pretty meaningfully.

Steven L. Hoerter: Yeah, we're not providing any further detail in terms of whether it would be a rolling submission or not.

I know, it's early days, but I just just curious have you gotten any early feedback from your enrolling physicians.

Christopher Joseph Raymond: Got it. Okay.

With respect to potential dynamics, there I mean, when when you should assume that that's.

Steven L. Hoerter: And then, um, just, um, on the intrigue study. So, um, you know, we just recently learned that, um, your competitor, Avipritinib second line compass trial was pushed back pretty meaningfully. I know it's early days, but I just, just curious, have you gotten any early feedback from your enrolling physicians with respect to potential dynamics there? I mean, one should assume that that's perhaps a plus in terms of enrollment dynamics, but just kind of curious if you've gotten any early feedback.

Perhaps.

Plus in terms of enrollment dynamics, but just kind of curious if you gotten any early feedback.

Yes. So we've we've been really pleased with the pace of getting intrigue up and running as you know we haven't had any competitive trial dynamic up until now and as you point out it looks like that we won't have the competitive trial for the foreseeable future as Matt mentioned in the prepared remarks, we have 92 sites now open we expect to open over 100.

Thanks for that study were active in 18 countries.

Steven L. Hoerter: Yeah, so we've been really pleased with the pace of getting Intrigue up and running. You know, as you know, we haven't had any competitive trial dynamic up until now, and as you point out, it looks like we won't have any competitive trials for the foreseeable future.

And we're really pleased with the pace both of our opening sites and also the pace of enrolling patients on the study.

As you would expect and we would expect based on the very positive Invictus results that we released in August of this year no theres a considerable amount of enthusiasm for the data in that fourth line fourth line plus setting and we believe that will translate meaningfully into enthusiasm for both patients as well as investigator.

Steven L. Hoerter: As Matt mentioned in the prepared remarks, we have 92 sites now open. We expect to open over a hundred sites for that study. We're active in 18 countries, and we're really pleased with the pace both of how we're opening sites and also of enrolling patients in the study. You know, as you would expect and we would expect based on the very positive Invictus results that we released in August of this year, there's a considerable amount of enthusiasm for the data in that fourth line, fourth line plus setting, and we believe that will translate meaningfully into enthusiasm for both patients as well as investigators thinking about the Intrigue study as an option in the second line setting.

Just thinking about the intrigue study as an option in the second line setting so still a little early to tell what that that pace of enrollment is going to look like but as you point out by virtue of the fact that we work ahead any way of blueprint and getting a second line study up and now the fact that they won't have a second line study its smooth sailing ahead.

For us at least in our view in terms of getting that study enrolled generating the data and then reporting results.

Steven L. Hoerter: So still a little early to tell what that pace of enrollment is going to look like, but as you point out, by virtue of the fact that we were ahead of the blueprint and got a second line study up, and now the fact that they won't have a second line study, it's smooth sailing ahead for us, at least in our view, in terms of getting that study enrolled, generating the data, and then reporting results. Thanks very much.

Great. Thanks very much.

Your next question comes from the line Michael Schmidt from Guggenheim Securities. Your line is open.

Hey, guys. This is Charles EU on for Michael Schmidt, Thanks for taking the questions and congrats on all the progress first one on intrigue I see on clinical trials Dot Gov. PFS is the primary endpoint with all our analysts a secondary so im wondering the degree to which plants for entry Alicia assessment is similar or different than that.

Michael Werner Schmidt: Your next question comes from the line of Michael Schmidt from Guggenheim Securities. Hey guys, this is Charles Zhu on behalf of Michael Schmidt.

Of Invictus as well as a potential for complication given patients coming off sutent could effectively crossover by accessing commercial and off trial written had been later lines of therapy.

Charles Zhu: Thanks for taking the questions and congrats on all the progress. First one on intrigue: I see on clinicaltrials.gov that PFS is the primary endpoint with ORR and OSS secondaries. I'm wondering the degree to which plans for intrigues OS assessment is similar or different than that of Invictus as well as the potential for complications given patients coming off Sutent could effectively cross over by accessing commercial and off-trial reprinted materials in later lines of therapy.

Yes, Hi, Charles it's Steve. Thanks, Thanks for the question, which is a good one you know you're right of course PFS is the primary endpoint.

It's not a study in which we allow crossover given that there is an approved therapy currently in the second line setting and I think you're you're also right in suggesting that it would be challenging in the second line setting given the availability of subsequent therapies for reprising of in that setting to demonstrate an overall survival benefit.

Steven L. Hoerter: Yeah, Charles, it's Steve. Thanks.

Steven L. Hoerter: Thanks for the question, which is a good one. You know, you're right. Of course, PFS is the primary endpoint. It's not a study in which we allow crossover, given that there is an approved therapy currently in the second line setting. And I think you're also right in suggesting that it would be challenging in the second line setting, given the availability of subsequent therapies for repregnant in that setting to demonstrate an overall survival benefit. But nonetheless, OS is a secondary endpoint in the study. We look forward, certainly, to getting patients on study and enrolling the study, generating the data, and then we'll report the data when they're available.

But nonetheless awareness is a secondary endpoint in the study we look forward certainly to getting patients on study and rolling the study generating the data and then we'll report the data when they're available.

Okay, Great and correct me, if I'm wrong, but I also think treat does not allow for dose escalation on the idea ponds progression and with that in mind, how many physicians feel about potential dose escalation in second line, just assuming intrigues sticks successful given intrigue doesn't explicitly stuff.

Yes, but you'll have data for it in the phase one as well as I guess kind of from Invictus in fourth line.

Yes, Thanks, Charles for the question on dose escalation, so you're right in the phase one study and we just provided the update that Matt described in his prepared remarks at the Triple meeting in Boston last week and of course, you're familiar with with the Invicta Seta, where does the escalation was also allowed for patients.

Charles Zhu: Okay, great. And correct me if I'm wrong, but I also think Intrigue does not allow for dose escalation on BID upon progression. And with that in mind, how might physicians feel about potential dose escalation in second line, just assuming Intrigue is successful given it doesn't explicitly study it, but you'll have data for it in phase one as well as, I guess, kind of from Invictus in fourth line

We're still in the early days for us on terms of our analysis of those those data and what the potential implications might be forward, how physicians ultimately might want to use this drug assuming it's approved whether it be in the fourth line setting or the second line setting. So I think this is religious the beginning of the drug development journey for us with us.

Steven L. Hoerter: Yeah, thanks, Charles, for the question on dose escalation. So you're right in the phase one study, and we just provided the update that Matt described in his prepared remarks at the TRIPLE meeting in Boston last week, and, of course, you're familiar with the Invictus data, where dose escalation was also allowed for patients. It's still in the early days for us in terms of our analysis of those data and what the potential implications might be for how physicians ultimately might want to use this drug, assuming it's approved, whether it be in the fourth-line setting or the second-line setting. So I think this is really just the beginning of the drug development journey for us with this product, clearly a highly active drug in GIST.

Product clearly a highly active drug in just in the fourth line setting I think the phase one study across second third and fourth line also clearly shows the drug is highly active and those lines of therapy and I think the challenge ahead for us and for the clinical community is going to be to determine going forward how will this drug and whats.

Setting and and at what dose, meaning does those dose escalation demonstrate a prolonged benefit for patients will have to sort through that I think in the coming coming years ahead as we continue to expand our understanding of the use of this drug ingest.

All right and makes sense and last one from me.

What's your view on the potential your view as well as any feedback you've gone from a tail wells you're investigators for the potential of repression of Rechallenge enforced line just if a patient has already received it in earlier lines, especially if such patient weren't previously dose escalated.

Steven L. Hoerter: In the fourth-line setting, I think the phase one study across second, third, and fourth lines also clearly shows the drug is highly active in those lines of therapy, and I think the challenge ahead for us and for the clinical community is going to be to determine, going forward, how this drug, in what setting, and at what dose, means dose escalation demonstrates a prolonged benefit for patients. We'll have to sort through that, I think, in the coming years as we continue to expand our understanding of the use of this drug in GIST.

Yes. Thanks, Charles Good question you know in this and this in this setting ingestion of certainly physicians are quite familiar and used to re challenge with them Adnan as an example.

And given the broad spectrum inhibitory profile of are predicated really addressing all of these relevant mutations that drive this disease I suppose it's not outside of kind of the realm of possibility that we may be able to pursue a similar path generate the data of course, but pursue a similar path with repetitive and explain.

Charles Zhu: Alright, makes sense. And last one from me: what's your view on the potential, your view as well as any feedback you've gotten from K.L. Wells or your investigators, for the potential of a repretentive re-challenge and fourth-line gist if a patient has already received it in an earlier line, especially if such a patient wasn't previously dose escalated?

For the potential for patients to benefit with the drug upon read rechallenge or Retreatment, we still need to of course understand that better generate data in that context, and see what sort of benefit the drug might offer so still a little bit early as I said, we view this as the initial set of steps and develop.

Steven L. Hoerter: Yeah, thanks, Charles. It was a good question. You know, in this setting in GIST, physicians are quite familiar and used to rechallenge with imatinib as an example. And, you know, given the broad-spectrum inhibitory profile of repretinib, really addressing all of these relevant mutations that drive this disease, I suppose it's not outside of the kind of the realm of possibility that we may be able to pursue a similar path, generate the data, of course You know, we still need to, of course, understand that better, generate data in that context, and see what sort of benefit the drug might offer. So, still a little bit early. As I said, you know, we view this as the initial set of steps in developing this drug in this disease, and we think there are future opportunities, certainly for us to explore, whether it be related to dose escalation or whether it be related to retreatment, as you point out.

Wrapping this drug in this disease, and we think there their future opportunities certainly for us to explore whether it be related to dose escalation or whether it be related to retreatment as you point out.

Great. Thanks for taking the questions and congrats again on all the progress.

Yes, Thanks Ross.

Your next question comes from the line a few Eun Yang from Jefferies. Your line is open.

Thank you.

Question on.

On the line Cesco foundry Pratt's names so Ken.

In phase two study shows PFS of about 24 weeks.

I'm Arbor published a paper just show PFS and all that about 36 weeks I would cheesy kill a lower than why you've recently shell and 46 weeks for.

Charles Zhu: Great. Thanks for taking the questions and congrats again on all the progress. Yeah, thanks.

Correct me, if so what I ask you watch your powering assumptions for Suneet Canadian aphasia three entry.

Charles Zhu: Yeah, thanks, Charles.

Yes, Thanks, Steve I'll take that question. So we of course has spent a lot of time over the last couple of years working with.

Eun Kyung Yang: Your next question comes from the line of Eun Yang from Jeffries. Your line is open.

Eun Kyung Yang: Question on second-line GIST for repretinib. So, SUTAN in Phase 3 showed PFS of about 24 weeks, but some other published papers show PFS of about 36 weeks, which is still lower than what you've recently shown, 46 weeks for repretinib. So, I want to ask you what are your powering assumptions for SUTAN in Phase 3 intrigue?

Expert thought leaders in the field to understand how the diseases treated and to understand contemporary view of the Sunitinib and what one might expect in terms of progression free survival in the second line setting you know you're right. We often point to of course, what's in the label the FDA approved label for Sunitinib.

Steven L. Hoerter: Yeah, thanks, Steve. I'll take that question.

Which is the 24 weeks of PFS that you referenced and they're also some smaller studies out there that have of course different PFS rates.

Steven L. Hoerter: So we, of course, have spent a lot of time over the last couple of years working with expert thought leaders in the field to understand how the disease is treated and to understand a contemporary view of sunitinib and what one might expect in terms of progression-free survival in the second line setting. You know, you're right; we often point to, of course, what's in the label, the FDA-approved label for sunitinib, which is 24 weeks of PFS. And there are also some smaller studies out there that have, of course, different PFS rates. And so as we've explored this and discussed the topic with the experts who treat the disease, the very consistent feedback that we've received is that, yes, 24 weeks is still the relevant mark in terms of what one would expect with sutent in the second line setting in this disease.

So as we've explored this and discuss the topic with the experts who treat the disease. The very consistent feedback that we've received is that yes, 24 weeks is still the relevant.

Mark in terms of what one would expect with Sutent and the second line setting and this disease.

You've also noted of course, the phase one, which we updated last week at the Triple meeting and Boston, where we showed in the cohort second line patients now.

Thats, a 46 weeks, which is a unimproved met a substantial improvement actually over the last data disclosure with repression of in that setting. So we remain very confident in our design and the underlying powering for the entry study as I noted earlier, we are looking forward to continuing to enroll patients and then to generate the data and reported out.

Steven L. Hoerter: So we remain very confident in our design and the underlying powering assumptions for the INTRIGUE study. As I noted earlier, we are looking forward to continuing to enroll patients and then to generate the data and report it out once we have that data generated. But I don't have any additional sets of powering assumptions that I can share with you at this time beyond what we've already disclosed.

Once we have that data generated but I don't have any additional set of powering assumptions that I can share with you at this time.

And what we've already disclosed.

Eun Kyung Yang: Okay. And then 3014, so CITAS, you guys mentioned a small group of patients with TGCT. In that study, with that data, would we be able to see a response rate that could be comparable to what PaxDartinib has shown, 38%?

Okay and then.

Already 14, so seed costs you have mentioned.

Okay got a number of patients.

We could Tc TGC key.

This study in that data well do we'd be able to see response rate could they be comparable to what pick Scott can you, maybe Sean 30, a perfect.

Steven L. Hoerter: Yeah, thanks, Ian, for the question on 3014. So, as you point out, what we reported last week at the triple meeting was phase one in the solid tumor patient population. And so we're looking forward to the CTOS meeting, the Connective Tissue Oncology Society meeting in Tokyo, which is coming up already next week. We'll be reporting for the first time data with 3014 in a small number of patients with tenosynovial giant cell tumor. And so included in that data set will be patients who, of course, are valuable for safety, but also patients who are valuable for efficacy. You know, I just point out that this is an initial small number of patients. We, of course, look forward to enrolling the expansion cohort that's open for that study and generating even more data in additional patients with 3014. And we hope to report out on a more complete, full data set over the course of 2020. But yes, next week, you can look for data that would include response to valuable patients.

Yes. Thanks, you for the question on 30 14, so as you point out what we reported last week at the Triple meeting was the phase one in the solid tumor patient population and.

And so we're looking forward at the C. Tossed meeting the connective tissue oncology Society meeting in Tokyo, which is coming up already next week, we'll be reporting for the first time data with 30 14 in a small number of patients with tennis snowmobile giant cell tumor and so included in that dataset will be.

Patients who of course are valuable for safety, but also patients who are valuable for efficacy I just point out that this is an initial small number of patients. We of course look forward to enrolling the expansion cohort that is open for that study in generating even more data in additional patients with 30, 14, and and we hope to repay.

Sort out on a more complete full data set over the course of 2020, but yes next week you can look for data that would include response evaluable patients.

Okay last question is on her basket. So at the trip permitting you showed about 21 person response rate.

Eun Kyung Yang: The last question is on Robustinib. So, at the TRIPPER meeting, you showed about 21% response rate, response rate at 50 mg BID, and recommended the phase 2 dose, but is there any kind of response rate that you have in mind that could determine a go, no-go decision for the program?

Response rate, if we can mitigate Mb I'd.

So many of the phase it together, but you see or any kind of.

Barack right do you have in mind.

Carmen go no go decision for the program.

Matthew L. Sherman: Yeah, so we have, certainly for Bastanov, you know, we have these four expansion cohorts that we're enrolling, and we outlined those in the poster that we presented last week. And, and maybe what I'll do is turn it to Matt, who can provide some additional color on those expansion cohorts and the decision that we'll make then for further expansion of the expansion cohorts, assuming certain criteria are met.

Yes. So we have we have certainly for bastion of you know we have these for expansion cohorts that were enrolling and we outline those in the poster that we presented last weekend and maybe what I'll do is trying to to Matt. He can provide some additional color on those expansion cohorts and the tea.

The decision that will make then for further expansion of the expansion cohorts assuming certain criteria are met.

Matthew L. Sherman: Yes, so again, thanks for the question. As we indicated, we'll be moving forward into Part 2 of the study with the four expansion cohorts, as I mentioned, in triple negative breast cancer, inflammatory breast cancer, ovarian cancer, and endometrial cancer. And in those patient populations, it's a Simon-Sue stage design, where we'll be enrolling the first group of 18 patients. And if there are more than four responses in the group of 18 patients, we then move into the second stage of the Simon-Sue stage design to enroll up to 33 patients. And so it's based on those numbers that we'll have a point estimate for.

Yes.

Thanks for the question. So as we indicated we'll be moving forward into the part to the study with the for expansion cohorts as I mentioned in triple negative breast cancer inflammatory breast cancer ovarian cancer in endometrial cancer, then those patient populations, it's a simon two stage design.

Well, we'll be enrolling the first group of 18 patients and if there is more than four responses in the group of 18 patients. We then move into the second stage of the Simon two states designed to enroll up to 33 patients and so it's based on those numbers that we will have a point estimate for the response rate and those four different in.

Occasions.

Eun Kyung Yang: And I would just add to that, Eun, that we're certainly encouraged by the early signs of efficacy with the combination and look forward to generating more data and more homogeneous patient populations in those expansion cohorts that Matt referred to. That's helpful. Thank you.

Okay, and I was thinking that add to that year, where we're certainly encouraged by the by the early signs of efficacy with the combination and look forward to generating more data and more homogeneous patient populations in those expansion cohorts that Matt referred to.

That's helpful. Thank you.

Your next question comes from the line of Christopher MRI from Nomura Instinet. Your line is open.

Eun Kyung Yang: That's helpful. Thank you.

Christopher Joseph Raymond: Your next question comes from the line of Christopher Murai from Nomura Internet. Your line is open.

Hi, This is Jackson Harvey on for Chris to first Thanks for taking my question I was just curious about.

Jackson Harvey: Hi, this is Jackson Harvey on behalf of Christopher. Thanks for taking my question. I was just curious about 3014. Could you provide some more color around the AST elevations? Did they have anything in common with pexidartanib as far as you could tell?

34 team could you provide some more color around the S&P elevation.

They have anything in common with extra darn near as far as you can tell.

Matthew L. Sherman: Yeah, Jackson and Steve, thanks for the question on 3014 and the AST elevations. I'll turn it over to Matt to address that.

Yes, Jackson as Steve. Thanks, Thanks for the question on 30, 14, and the elevations I'll turn it over to match to address that.

Matthew L. Sherman: Hi Jackson. So again, thanks for the question. And as you noted, with this class of agents, one can see elevations in certain liver enzymes, particularly AST and ALT. And in part, that's due to a decreased clearance of these enzymes within the liver due to the targeted nature of the products against the CSF1 receptor. Now, in Pexigarden's case, though, there were a number of patients who went on to, in addition to having elevations of liver function enzymes, there was frankopatatoxicity that was reported in their Phase 3 enlivened study and across their program as well, too. So that maybe represents a different type of toxicity beyond the benign elevations of liver function tests.

Hi, Jackson. So you again, thanks for the question as you noted.

With this class of agents, one can see elevations in certain liver enzymes, so, particularly HST in AOCI can be elevated in part that's due to decrease clearance of these enzymes within the liver due to the targeted nature of the.

Of the products against the CSF, one receptor known pacing Darden hymns case, though there was a number of patients who went onto an addition to having elevations of liver function enzymes. Those friend Capello toxicity that was reported in their phase three in life and studies and across the program as well too. So that may be represents a different type of toxicity beyond that.

Benign elevations of liver function test.

Great God and ask you think about possible registration studies do you anticipate having to do head to head studies with extra dart in it.

Jackson Harvey: Great. Got it. And as you think about possible registration studies, do you anticipate having to do head-to-head studies with pexidartanib?

Yes, Thanks Jackson for the question too early for us to tell really exactly what what the design of a registration study might be whether it could be a single arm study whether it could be a randomized study like the enliven study versus placebo or a head to head versus packs, it's not clear to us that we would need to do a head to head versus picks at Arden, but.

Steven L. Hoerter: Yeah, thanks, Jackson, for the question. It's too early for us to tell, really, exactly what the design of a registration study might be, whether it could be a single-arm study, whether it could be a randomized study like the Enliven study versus placebo or a head-to-head versus PECS. It's not clear to us that we would need to do a head-to-head versus PECS at ARTnode, but it's still a little early for us to comment on what future development paths might be. We look forward to presenting the data next week and then to generating further data and additional patients with TGCT.

Still a little early for us to comment on what future development pass might be we look forward to presenting the data next week and then to generating further data and additional patients with TGC.

Great. Thanks for addressing my question.

You bet.

Your next question comes to the line a friend Benjamin from J.M. peak Sir.

Your line is open.

Hey, Thanks, guys for taking the questions.

And congrats on the on all the progress I guess beyond just can you talk a little bit about your strategy for FM.

Anticipate initiating.

Jackson Harvey: Great, thanks for addressing my questions.

Some trial.

Reni John Benjamin: We'll be back.

How are you, making the decisions there and I guess related to that when might we see an update from the FM cohort of the glioma and non small cell lung cohorts of.

Steven L. Hoerter: Your next question comes to the line of Ren Benjamin from JMP Sec. Your line is open.

Reni John Benjamin: Hey, thanks guys for taking the questions, and congrats on all the progress. I guess beyond JIST, can you talk a little bit about your strategy for SM? Do you anticipate initiating, you know, an ISM trial? You know, how are you making the decisions there? And I guess related to that, when might we see an update from the SM cohort or the glioma and non-small cell lung cohorts of RIP pregnant

Right.

Yeah, I rented Steve Thanks for the question and and on SM, specifically, so as you know this was an expansion cohort is an expansion cohort in the phase one study.

And we've been working really hard to get patients on study, it's not to be Frank not been the easiest.

Cohort for us to enroll we think we've made some good progress recently and we would hope and expect to have a data update during the course of 2020. Once we have a critical mass of patients enrolled and they've been on therapy for.

Steven L. Hoerter: Yeah, hi Ren, it's Steve. Thanks for the question and on SM specifically. So, as you know, this was an expansion cohort, is an expansion cohort, in the Phase 1 study, and we've been working really hard to get patients into the study. It's not, to be frank, not been the easiest cohort for us to enroll. We think we've made some good progress recently, and we would hope and expect to have data update during the course of 2020 once we have a critical mass of patients enrolled and they've been on therapy for the necessary period of time to evaluate for response. So look for data in 2020. We don't have any further comment or guidance at this time until we generate data on what a further development path might look like.

The necessary period of time to evaluate for response, so look for data in 2020, we don't have any further comment or guidance at this time until we generate those data on what a further development path might look like.

Got it and then just regarding fragmented.

What are your thoughts regarding combination studies.

In just is it it seems like Mechanistically that it should work out perfectly, but maybe the side effect profile is overlapping just any sort of thoughts you might have regarding that going forward.

Yes, thanks, Ren suffer a prednisone typically and thinking about combination therapies recall that we never reached an MTD with this drug in the phase one study and as we talked about earlier on the call. We have a number of patients who in fact of dose escalated to 150 be I'd and the drug appears to be very.

Reni John Benjamin: Got it. And then just regarding RepretMib, you know, what are your thoughts regarding combination studies in GIST? It seems like mechanistically that it should work out perfectly, but maybe the side effect profile is overlapping. Just any sort of thoughts you might have regarding that going forward.

Well tolerated in that context as well. So we think in fact to that repression of is uniquely positioned as an agent that has a really good therapeutic index and may well be a good combination partner with other agents, whether targeted or non targeted agents and so we're not ready at this time to talk about why.

Steven L. Hoerter: Yeah, thanks, Ren. So for Reprednib specifically, and thinking about combination therapies, you know, recall that we never reached an MTD with this drug in the Phase I study. And as we talked about earlier on the call, we have a number of patients who, in fact, have dose escalated to 150 BID, and the drug appears to be very well tolerated in that context as well. So we think, in fact, that Reprednib is uniquely positioned as an agent that has a really good therapeutic index. And may well be a good combination partner with other agents, whether targeted or non-targeted agents. And so we're not ready at this time to talk about what potential combinations might look like, but certainly, it's something that's on our radar.

What potential combinations might look like but certainly it's something that's on our radar you know I referenced earlier that this is the beginning of what we think is going to be very lengthy and productive journey as we explore the potential role for this drug in the treatment of just and potentially other tumor types and whether that be.

There be or a combination we're committed to exploring all of those avenues and seeing how this drug may be able to most optimal they benefit patients across a variety of different lines of therapy and a different settings.

Great and just one final one regarding a commercial sales force can you just give us your latest thoughts on.

Steven L. Hoerter: I mentioned earlier that this is the beginning of what we think is going to be a very lengthy and productive journey as we explore the potential role for this drug in the treatment of GIST and potentially other tumor types. And whether that be as monotherapy or combination, we're committed to exploring all of those avenues and seeing how this drug may be able to benefit patients across a variety of different lines of therapy and in different settings.

How big it should be will you be ready to start selling as soon as you get approval.

And kind of where you are right now in the hiring process.

Yes, so we've been really pleased with the team that we've been able to attract to decipher to fill all of the roles across the commercial organization and the medical Affairs organization. These are all folks that have a deep oncology experience many of them have deep experience launching oral oncolytics and the you asked me.

Reni John Benjamin: Great, and just one final one, regarding a commercial sales force, can you just give us your latest thoughts on how big it should be, will you be ready to start selling as soon as you get approval, and kind of where you are right now in the hiring process?

Market and so we're really thrilled with the quality of the team we're doing a lot of work right now to think through and finalize what our go to market strategy is going to be specifically for the field sales organization and so it'd be premature for me to comment specifically on what a final number might be I can give you a range, we would expect to see.

Steven L. Hoerter: Yeah, so we've been really pleased with the team that we've been able to attract to Deciphera to fill all of the roles across the commercial organization and the medical affairs organization. These are all folks who have deep oncology experience. Many of them have deep experience launching oral oncolytics in the U.S. market, and so we're really thrilled with the quality of the team. We're doing a lot of work right now to think through and finalize what our go-to-market strategy is going to be specifically for the field sales organization, and so it would be premature for me to comment specifically on what a final number might be. I can give you a range. We would expect to see somewhere in the range of 40 to 60 sales representatives in the U.S. On the medical affairs side, we have now filled the entire MSL team, and again, an absolutely fantastic group of folks that we have in the MSL organization, and that team is already trained and prepared and out speaking with physicians about the disease and management of the disease.

Somewhere in the range of 40 to 60 sales representatives in the US on the medical Affairs side, we have now filled the entire MSL team and again I'd absolute absolutely fantastic group of folks that we have in the MSL organization and that team has already trained and prepared and now speaking with the physician.

Sounds about just about the disease and management of the disease. So the teams working really hard across all functions to make sure that we're prepared as I've mentioned in my prepared remarks for a potential approval next year and we're committed to doing everything in our power to have all the right people hired and trained and ready to go so that.

Steven L. Hoerter: So the team's working really hard across all functions to make sure that we're prepared, as I mentioned in my prepared remarks, for a potential approval next year, and we're committed to doing everything in our power to have all the right people hired and trained and ready to go so that when the FDA acts on the application, and, assuming approval, we're ready to get this drug out to the broader group of patients who are in need of it.

When the FDA acts on the application and assuming approval, we're ready to get this drug out to the broader group of patients who are in need of it.

Terrific. Thanks for taking the questions and congrats again.

Yes, Thanks Ryan.

Ladies and gentlemen, if you have a question. Please press Star then number one when your telephone keypad.

Again that is star then number one on your telephone keypad.

Reni John Benjamin: Thanks for taking the questions and congrats again.

Your next question comes from the lineups and it ROI from Jones trading your line is open.

Senate Roy: Yeah, thanks, Ren.

Senate Roy: Ladies and gentlemen, if you have a question, please press star, then number 1 on your telephone keypad. Again, that is star, then number one on your telephone keypad. Your next question comes from the line of Senate Roy from Jones Trading. Your line is open.

Mr. Roy.

Your line is open.

Okay, operator, maybe we should go to the next caller on assertion that maybe is on theater had to step away.

Thank you when.

Your next question comes from the line of fleet. The Lee from Canaccord. Your line is open.

Okay. Thanks for taking my questions in congrats.

Senate Roy: Mr. Roy,

Senate Roy: Your line is open.

Operator: Okay, operator, maybe we should go to the next caller. I'm not sure if Shomit is maybe on mute or had to step away.

Issue.

I had a question about.

Any data that you might have been able to glean from the PD G. R.

Operator: Thank you. One moment. Your next question comes from the line of Lien Beli from Canuckport. Your line is open.

Patients.

Just studying that might give you any read through to that.

Lien Beli: Hi guys, thanks for taking my questions and congrats on the breakthrough designation. I had a question about any data that you might have been able to glean from the PDGFR?

And efficacy.

Thank you Hey, Arlinda, it's Steve. Thanks, Thanks for the question with respect to the PDGF Our office and are you, referring specifically to the patients in the Invicta study.

Arlinda: Patients from the GIST study and if that might give you any read-through to that as well.

Steven L. Hoerter: Yeah, hey, Arlinda, it's Steve. Thanks. Thanks for the question. With respect to the PDGFR alpha,

Yes, so so as you know looking at the the patient demographics, we had relatively few patients PDGF. Our alpha patients enrolled we only had I think it was three a handful of them really and the refreshing of arm and none in the placebo arm. So we don't have any real.

Steven L. Hoerter: Hey Ireland, it's...

Steven L. Hoerter: Thank you. Thank you. Thank you.

Steven L. Hoerter: Yeah, so as you know, looking at the patient demographics, we had relatively few patients, PDGFR-alpha patients enrolled. We only had, I think it was three, a handful of them really, in the repretinib arm and none in the placebo arm.

Steven L. Hoerter: So we don't have any real conclusions that we can draw from the data. We haven't yet broken out the data by subgroup, so it really doesn't offer us any help or guidance. You know, I think with respect to SM, the key question will be generating data in that specific population. As I noted earlier, we're committed to enrolling that cohort and generating the data and presenting those data in 2020. So I'd say stay tuned for SM. Let us get some patients on study, generate some data in those patients, and then we look forward to presenting those data in 2020.

Inclusions that we can draw from those data we haven't yet broken out data by sub group. So really doesn't offer us any any help or guidance I think with respect to SM is the key question will be generating data in that specific population.

As I noted earlier, we're committed to enrolling that cohort and generating the data and presenting those data in 2020, So I'd say stay tuned on SM, let us say get some patients on study generate some data in those patients and then we look forward to presenting it next year.

Okay.

I'm showing no further questions at this time.

Steven L. Hoerter: I would now like to turn the conference back to Steve Hoerter, President and CEO. Please go ahead, sir.

Ill like to turn the conference back to Steve Hager, President and CEO . Please go ahead Sir.

Steven L. Hoerter: Great, thanks. I'd like to thank all of you for joining us today on the call. Thanks for your interest and continued support. We're looking forward to an exciting close to the year this year and then in 2020, generating additional data from our pipeline and preparing for the launch, potentially, of our first therapy, RepretNib. Thank you, and have a great afternoon.

Great. Thanks like to thank all of you for joining us today on the call. Thanks for your interest and continued support we're looking forward to an exciting close to the year. This year and then in 2020 generating additional data from our pipeline and preparing for the launch potentially of our first therapy repression of thank you and have a good afternoon.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for participating and have a wonderful day. You may all disconnect.

Ladies and gentlemen, this concludes todays conference call. Thank you for participating and have their wonderful day.

Operator: ??? ??? ??? ??? ???

Operator: The Bulletproof Executive, 2013

You may all disconnect.