Q1 2020 Earnings Call

May 5, 2020

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Good afternoon, everyone and welcome to the de Sac decide for for Medicals first quarter 2020 financial results Conference call. Today's call is being recorded at this time I would like to turn the call over to Jan Robertson Vice President.

Unknown Executive: Good afternoon, everyone, and welcome to the Decipher Pharmaceuticals first quarter 2020 financial results conference call. This call is being recorded.

Unknown Executive: At this time, I would like to turn the call over to Jen Robertson, Vice President, Investor Relations. Thank you, Jen, go ahead. Thank you, Federica. Welcome, and thank you for joining us today to discuss Deciphera's first quarter 2020 financial results. I'm Jen Robinson, Vice President, 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, and Matt Sherman, Chief Medical Officer. Dan Martin, Chief Commercial Officer, and Tucker Kelly, Chief Financial Officer.

<unk> Investor Relations. Thank you Jane go ahead.

Thank you.

Welcome and thank you for joining us today to discuss the favorite first quarter 2020 financial result, Amgen Madison, Vice President Investor Relations at the site.

With me this afternoon discuss the financial results and provide a general corporate update or Steve Scherger, President and Chief Executive Officer.

Sherman Chief Medical Officer, San Martin, Chief Commercial Officer, and Packer, Kelly Chief Financial Officer.

Before we begin I'd like to remind you that any statements. We make on this call that are not surgical site are forward looking statement.

Jennifer Larson: 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 expected timelines for, our preclinical and clinical studies, the impact of COVID-19, 2020 guidance, review and status of our NDA submission, and preparations for potential commercial bonds. 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 the impact of COVID-19, the execution of clinical trials, the timing of study 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.

I think the current beliefs and expectations of management me pursuant to the Safe Harbor provision of the private Securities Litigation Reform Act of 1995.

Examples of forward looking statements made during this conference call include the status of our expected timeline for our preclinical and clinical study.

Technical good night.

2020 died in review I said, it's about 98 submission and preparations for our for potential commercial launch.

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 expectation will be achieved.

Such risks and uncertainties include the impact of cobot, making the execution of clinical trials. The timing of study data the actions of regulatory agencies and those set forth and our most recent quarterly reports on form 10-Q, as well as other our other SEC filings.

We assume no obligation to update or revise any forward looking statement.

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

Following this call a replay will be available on the company's website W.W. dot to Cyprus dotcom with that I'll now turn the call over to Steve Herder, President and Chief Executive Officer of decipher eat.

Thank you Dan Good afternoon, everyone and thank you for joining us on this call to discuss our first quarter 2020 financial results. In addition to providing our financial results and regular quarterly business update today. We are also reaffirming the timing of our clinical and commercial milestones and providing an update on the potential for covered 19.

Steven L. Hoerter: Good afternoon, everyone, and thank you for joining us on this call to discuss our first quarter 2020 financial results. In addition to providing our financial results and regular quarterly business updates, today we are also reaffirming the timing of our clinical and commercial milestones and providing an update on the potential for COVID-19 to affect the business. Given the uncertainties that the COVID-19 pandemic presents, I want to emphasize that the outlook presented today is based on the assumption and the hope that the most severe impacts will be of a short-term nature over the next few months, rather than a prolonged and sustained disruption to everyday life. At Deciphera, our first concern is maintaining the safety and security of our employees, as well as the patients and physicians participating in our ongoing clinical trials. And this principle has guided the actions we've taken today. In early March, we adopted a work-from-home policy for our employees, with limited exceptions for certain business-critical activities, including ongoing laboratory research activities. For these activities, we have implemented appropriate safety measures designed to comply with federal, state, and local guidelines.

To affect the business.

Given the uncertainties that the covert 19 pandemic present, so I want to emphasize that the outlook presented today.

Based on the assumption in the hope that the most severe impacts are of a short term nature over the next few months, rather than a prolonged and sustained disruption to everyday life.

At the site for our first concern is maintaining the safety and security of our employees as well as the patients and physicians participating in our ongoing clinical trials and this principle has guided the actions we've taken today.

Steven L. Hoerter: While adapting to our new work environment has presented its challenges, I have been continually impressed by the team's ability to adjust while steadfastly maintaining our corporate values and executing on our company's. As the COVID-19 pandemic has spread around the world, the Deciphera team has worked to ensure the safety and well-being of patients enrolled in our clinical studies and their clinical staff. We are focused on advancing our ongoing clinical studies and are We are in frequent communication with our clinical study sites and contract research organizations around the world. As you may be aware, some clinical trial sites are restricting site visits by sponsors and CROs and imposing restrictions on the initiation of new trials, new patient enrollment, and patient visits to protect both site staff and patients from possible COVID-19 exposure.

In early March we adopted a work from home policy for our employees with limited exceptions for certain business critical activities, including ongoing laboratory research activities.

For these activities, we have implemented appropriate safety measures designs to comply with federal state and local guidelines.

While adapting to our new work environment as presented its challenges I have been continually impressed by the team's ability to adjust both successfully maintaining our corporate values and executing on our company's mission.

As the covert 19 pandemic a spread around the world. The decipher team has worked to ensure the safety and well being of patients enrolled in our clinical studies and their clinical teams.

Steven L. Hoerter: While our studies remain open for enrollment, we have provided guidance so that new patient enrollment may occur at sites where resources allow these patients to be safely enrolled and closely monitored. And some sites in our studies have temporarily paused enrollment of new patients. Importantly, patients already enrolled in all of our clinical studies continue to receive investigational drugs, and we are focused on supporting sites and providing ongoing care for these patients. We are also actively implementing remote and local procedures per recent FDA guidance and working with investigators to help ensure patients receive care in a safe manner, consistent with agency guidelines. As of this time, while there has been a slowdown in patient enrollment in the current environment, we currently expect to achieve our previously stated clinical milestones in the second half of this year, including full enrollment and entry into our phase three study and second line JIT, updated clinical data for DCC3014 from the dose escalation portion of the study in tenosynovial giant cell tumor patients. Selection of a Phase 2 dose for DCC3014 and Opening the Expansion Portion of the Study in TGCT Patients and updated clinical data from both of the Phase 1b studies of Rabastin.

We are focused on advancing our ongoing clinical studies and are actively monitoring risks associated with potential interruptions to our programs. We are in frequent communication with our clinical study sites and contract research organizations around the world.

As you may be aware some clinical trial sites are restricting site visits by sponsors NCR rose and imposing restrictions on the initiation of new trials, new patient enrollment and patient visits to protect both site staff and patience from possible covert 19 exposure.

While our studies remain open for enrollment we have provided guidance that new patient enrollment may occur at sites, where resources allow these patients to be safely enrolled and closely monitored.

And some sites and our studies have temporarily pause enrollment of patients.

Importantly, patients already enrolled and all of our clinical studies continue to receive investigational drug and we are focused on supporting sites and providing ongoing care for these patients.

We're also actively implementing remote and local procedures per recent FDA guidance and working with investigators to help ensure patients receive care and a safe manner consistent with agency guidelines.

As of this time, while there has been a slowdown in patient enrollment in the current environment. We currently expect to achieve our previously stated clinical milestones in the second half of this year, including full enrollment in and treat our phase three study in second line just.

Updated clinical data for GCC 30, 14 from the dose escalation portion of the study in tennis Inovio Giants cell tumor patients.

Selection of the phase two dose for GCC 30, 14, and opening the expansion portion of the study in TGC patients.

And updated clinical data from both of the phase one of these studies of her bassinet.

In addition, our discovery research per clinic preclinical efforts and early development activities are currently on track and we expect to file the R&D for DCC 31, 16 are all kinase inhibitor in the second half of 2020.

Steven L. Hoerter: In addition, our discovery research, preclinical efforts, and early development activities are currently on track, and we expect to file the IND for DCC 3116, our ULK kinase inhibitor, in the second half of 2020. In terms of drug supply, Deciphera has commercial drug supply sufficient to support the potential launch of Repretinib and Fortlign JIT. Based on current inventories and supply plans, the company does not anticipate any COVID-19-related supply interruptions to its clinical programs at this time.

In terms of drug supply decipher has commercial drug supply sufficient to support the potential launch of recruitment and fourth line Jess.

Based on current inventories and supply plan. The company does not anticipate any coated 19 related supply interruptions to its clinical programs at this time.

With respect to our new drug application or end da former president of in patients with fourth line. Jess we continue to work very collaboratively with the FDA as they review the submission which has a PDUFA target action date of August 13 this year.

Steven L. Hoerter: With respect to our new drug application, or NDA, for repretinib in patients with fourth-line GIST, we continue to work very collaboratively with the FDA as they review the submission, which has a PDUFA target action date of August 13th this year. We continue to build our commercial and medical affairs organizations to be ready to launch RepretNED in the U.S. upon potential approval. The RepredNib NDA is also part of Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among participating international health authorities.

We continue to build our commercial and medical affairs organizations to be ready to launch represented in the us upon a potential approval.

The refresh of India is also part of project Orbitz and initiative of the FDA Oncology Center of excellence that provides a framework for concurrent submission and review of oncology drugs among participating international health authorities.

Under this program we have received priority review for a new drug submission with health, Canada, and the market authorization application with the therapeutic goods administration, and Australia for refreshment and advanced chips.

Steven L. Hoerter: Under this program, we have received priority review for a new drug submission with Health Canada and a market authorization application with the Therapeutic Goods Administration in Australia for repregnant in advanced JIT. In addition, we plan to submit a marketing authorization application to the European Medicines Agency in the second half of this year. Given the evolving landscape, our commercial team has been preparing for a potential launch of Repretnib in a healthcare environment limited to no physical input to promotional activities and therefore has been working intensively on an effective commercial launch using a virtual interaction model, if necessary. Lastly, we are in a strong position from a cash-for-runway perspective, which we expect to last us into the second half of 2020. Despite the challenges we face, we expect this to be an exciting year.

In addition, we plan to submit a marketing authorization application to the European Medicines agency in the second half of this year.

Given the evolving landscape our commercial team has been preparing for potential launch for threatened to in the healthcare environment limited to no physical and promotional activities.

For the fourth the intensively on an effective commercial launch user.

Interaction model if necessary.

Lastly, we are in a strong position from a cash from my perspective, which we expect to lab tests into the second half of 2026.

Despite the challenges we face we expect this exciting year cycle.

Steven L. Hoerter: In particular, we look forward to a successful and impactful first commercial launch of Repretinib in fourth-line GISTs, if approved, and to achieving full enrollment in Intrigue. And we remain confident about Repretinib's potential to alter the treatment landscape for patients in the post-samadhinic setting. Beyond RepRetNib, we believe that our earlier stage programs can each deliver significant value-creating events, with additional clinical data for DCC 3014 and RepAstinib and the filing of an IND for DCC 3116 later this year to review progress on our clinical program. I'll now turn the call over to Matt Sherman, our Chief Medical Officer. Matt.

Particular, we look forward to a successful and impactful first commercial launch of refreshments and fourth line Jets, if approved and to achieving full enrollment and entry.

And we remain confident about refreshments potential to alter the treatment landscape for patients in the post a mountain of setting.

Beyond regret that we believe that our earlier stage programs can each delivers significant value, creating a debts with additional clinical data for DC, Cdthirty 14, and Rapastinel and the filing of an eye Andy for GCC 31, 16 later this year.

To review progress on our clinical programs ill now turn the call over some Nat Sherman, our Chief Medical Officer, Matt.

Thank you Steve.

Matthew L. Sherman: Thank you, Steve. First, I would like to review our progress with our pregnancy, our investigational broad-spectrum kit, and PDGF-alpha kinase inhibitor. As Steve mentioned, the NDA for approval of a pregnant patient with splatline GIST is currently under priority review by the FDA with a PDUFA date of August 13th this year. The NBA's Commission is supported by highly significant and, quite meaningfully, positive results from our Invictus Pivotal Phase III study of recruitment in patients with 4th line and 4th line plus. Today, we also announced that two posters containing additional data from the Infectious Study will be featured at the annual meeting, which is being held virtually this year from May 29 through May 31. The first poster will focus on quality of life outcomes with reproductive in the fourth line and fourth line class treatment setting.

Matthew L. Sherman: While the second poster will focus on the safety profile for pregnant women, including the impact of adverse events on patient-reported outcomes. We look forward to reporting these data later this month. As we work toward the potential approval and launch of the Apprentice and Patients with Advanced... who have received prior treatment with imatinib, subunitinib, and regoraptinib, we continue to explore other possible uses of reprintinib, including, in the second line, just paper.

First I'd like to review our progress, we're proving that our investigational broad spectrum kit MPV, Jennifer Alpha kinase inhibitor.

Steve mentioned, the NPV for approval over pregnant patients with four point just is currently under priority review by the FDA with a PDUFA date of August 13th this year.

The NDA submission. This supported however, we significant and currently meaningfully positive results from our tick. This pivotal phase three study of recruitment in patients with fourth line and fourth line clubs.

Today, we also in that comes with the Spurs considering additional data from in pick. This study will be featured.

Well meeting, which is being held virtually this year for May 29 through May 30 Onest.

The first poster will focus on quality of life outcomes with written dip in the fourth one important point plus treatment settings, while the second poster will focus on the safety profile per printed including the impact of adverse events on patient reported outcomes.

We look forward to reporting these data later this month.

As we work towards the potential approval and launch of there have been patients for advanced chips. We've received prior treatment with mandated sunitinib and record after that we continue to explore other possible uses over printed including in second line just patrons.

Matthew L. Sherman: Intrigue is our ongoing randomized phase 3 study of recreation in patients with second-line GIFs compared to the current standard of care soon to take effect. We have now finalized the amendment for Intrigue, and the sample size will be 426 patients. We have approximately 118 sites activated in 22 countries.

Intrigue is our ongoing randomized phase three study ever created in patients with second line Jeff.

Compared to the current standard of care significant.

We have now finalized the amendments were intrigue and the sample size will be 426 patients.

We have approximately 118 sites activated in 22 countries.

The global diversity and number of sites have been beneficial in helping us continue to enroll patients as we target full enrollment.

Matthew L. Sherman: The global diversity and number of sites have been beneficial in helping us continue to enroll patients as we target full enrollment this year. Additionally, as Steve mentioned, our clinical team has been in close correspondence with study sites to implement remote and local procedures per the recent FDA guidance to ensure the appropriate care of patients. In addition, we expect to present data from at least one of the extension cohorts of our ongoing Phase I study that were presented in the second half of this year. Beyond ribritinib, we are focused on the development of DCC3014, our selective inhibitor of CSF1R, for patients with tenosynovial giant cell tumor, or TGCT.

Half of this year. Additionally, as Steve mentioned, our clinical team has been close correspondence with study sites to implement remote and local procedures per the recent FDA guidance to ensure the appropriate care of patients.

In addition, we expect present data from at least one of the expansion cohorts of our ongoing phase one study of written in the second half of this year.

Beyond that Britain. There we are focused on the development of DCC 30, 14 hour selective inhibitor of CSF want our for patients with tenants Inovio Giants cell tumor or TGC too.

We believe 34 team has the potential to fulfill the unmet medical need for an effective treatment with a favorable safety profile for these patients.

Matthew L. Sherman: We believe 3014 has the potential to fulfill the unmet medical need for an effective treatment with a favorable safety profile for these patients. The only approved systemic therapy for patients with TGCT is texidartenib, a small molecule inhibitor of a number of different kinases, including CSF1R, which was approved in August of last year with a boxed warning for hepatitoxicity and is subject to a risk evaluation We are continuing to enroll TGCT patients in the ongoing dose escalation portion of the Phase 1 study. However, in the second quarter, due to the COVID-19 pandemic and given that this is not a life-threatening disease, we are seeing a slower-than-expected enrollment rate. Despite this, we are still currently expecting to present data from additional patients in this study, select a Phase II dose, and open the Phase II expansion portion of the study in TGCT patients in the second half of this year. Turning now to ribasinib, our potent and selective type 2 inhibitor, we are conducting two clinical studies in combination with chemotherapy, one with paclitaxel and one with carboplatin. Part one of each study was designed to select a combination dose of ribasamide with each chemotherapeutic agent, and part two of each study was designed as a Simon two-stage design.

The only approved systemic therapy for patients with TCT is teksid doctrine that a small molecule inhibitor of a number of different kind aces, including sales with one our which was approved in August of last year with a boxed warning for hepatic toxicity and is subject to a risk evaluation the mitigation strategy or Rems program.

We are cook, we're continuing to enroll TGC patients and the ongoing dose escalation portion of the phase one study.

In the second quarter due to the Coca 19 pandemic and given that this is not a life threatening disease, we are seeing a slower than expected enrollment trend.

Despite this we are still currently expecting to present data from additional patients in this study select a phase two dose and open the phase two expansion portion of the study in TGC t. patients in the second half of this year.

Turning down to turning now to a best in the our potent and selective tied to inhibitor. We're conducting two clinical studies in combination with chemotherapy, one with Paclitaxel and one with carbo platinum.

Matthew L. Sherman: In the first stage, the combinations are being evaluated in multiple solid tumor cohorts in up to 18 patients each. If there are more than four responses in a given cohort, then that cohort is expanded in the second stage to enroll up to a total of 33 patients. Last year, we presented preliminary data from Part 1 of the study of ribasinib in combination with paclitaxel. These showed encouraging preliminary activity with objective responses in patients who have previously received tacotaxel therapy across multiple solid tumor types.

Matthew L. Sherman: This afternoon, we announced that in Part 2 of the Paclitaxel Combination Study, we observed the required number of responses in both the endometrial and ovarian cancer cohorts, triggering the expansion of enrollment in these cohorts. We also announced today that we will present initial data from the Endometrial Cohort in part 2 of the study at the ASCO meeting this year. In addition, we have added a new carcinosarcoma cohort in Part 2 of the study based on the encouraging antitumor activity from Part 1 presented at the TRIPLE meeting last year that showed partial responses in both patients with carcinosarcoma who were enrolled in the trial. In our Phase 1B2 study with ribacinib in combination with carboplatinin, we're continuing to enroll patients with breast cancer, ovarian cancer, and mesothelioma in Part 2 of the study at the recommended Phase 2 dose of 50 milligrams BID, which was reduced from 100 milligrams BID based on the observed frequency of muscular weakness and preliminary data from the ongoing Part 2 portion of the study

Part one of each study was designed to select the combination dose of are best in that with each chemotherapeutic agent and part two of each study was designed as a signed in two stage design.

In the first stage the combinations are being evaluated in multiple solid tumor cohorts in up to 18 patients each.

If there are more than four responses in the given cohort than that cohort is expanded in the second stage to enroll up to a total of 33 patients.

Last year, we presented preliminary data from part one of the study upper best and they've been combination with Paclitaxel.

These are encouraging preliminary activity with objective responses in patients who have previously received paclitaxel therapy across multiple solid tumor types.

This afternoon, we announced that in part two of the Paclitaxel combination study we have observed the required number of responses in both the endometrial and ovarian cancer cohorts triggering the expansion them enrollment in these cohorts. We also announced today that we will present initial data from the into mutual cohort in part to the study at the ASCO.

During this year.

In addition, we've added a new Carson of sarcoma cohort in part two of the study based on the encouraging anti tumor activity from part one presented at the Triple meeting last year that showed partial responses in both patients with Carson of sarcoma, who were enrolled in the trial.

And our phase one be two study with Redev summit in combination with Carboplatin and we're continuing to enroll patients with breast cancer ovarian cancer and these affiliate in part to the study at the recommended phase two dose of 50 milligrams be I'd, which was reduced from 100 milligrams VIP based on the observe frequency of.

Square weakness and preliminary data from the ongoing part two portion of the study.

We expect to present data from part one of this study in the second half of this year.

Matthew L. Sherman: We expect to present data from Part 1 of this study in the second half of this year. Finally, our discovery research engine continues to generate new product candidates for novel targets, and we disclosed last year that the next target we'll be pursuing is ALK kinase, the initiating factor in the autophagy pathway. Namely, DCC 3116 is our potential first-in-class O-kinase inhibitor that we intend to develop for the treatment of mutant RAS cancer, and we continue to expect to file the IMD for this program later this year. Decipher is a company founded on deep insights into kinase biology and inspired by the prospect of developing important new medicines for the treatment of cancer.

Finally, our discovery research engine continues to generate new product candidates for novel targets and we disclosed last year at the next target will be pursuing as the oak kind is initiating factor in your top of GE pathway.

Namely DCC 31, six team is our potential for some class oil kinase inhibitor that we intend to develop for the treatment immune wraps cancers, and we continue to expect to file the item di for this program later this year.

The safer is a company founded on deep insights into context biology, and inspired by the prospect of developing important new medicines for the treatment of cancer, but for this year, we have demonstrated our ability to remain focused on discovering and developing novel drug candidates based on our proprietary research. Despite the significant challenges that the site.

Daniel C. Martin: Thus far this year, we have demonstrated our ability to remain focused on discovering and developing novel drug candidates based on our proprietary research, despite the significant challenges that Deciphera and the biotechnology community as a whole face from the ongoing COVID-19 pandemic. I look forward to updating you on the progress with our clinical and preclinical programs throughout the year. I will now turn the call over to Dan Martin, our Chief Commercial Officer, to discuss our commercial preparations for a potential launch of our print in the U.S. Dan? Thank you, Matt.

And the biotechnology community as a whole faces from the ongoing coated 19 pandemic.

I look forward to updating you on the progress with our clinical and preclinical programs throughout the year.

I'll now turn the call over to Dan Martin, Our Chief commercial officer, and discuss our commercial preparations for a potential launch of our printing in the us.

Dan.

Thank you Matt.

Since its founding decipher what has been steadfast and its mission to discover and develop innovative therapies to improve the lives patients with cancer worldwide now as we prepare for the potential commercial launch for pregnant. These high organization is laser focused on ensuring we optimize our ability to bring this important therapy to patients in need despite the challenge.

Daniel C. Martin: Since its founding, Deciphera has been steadfast in its mission to discover and develop innovative therapies to improve the lives of patients with cancer worldwide. Now, as we prepare for the potential commercial launch of Prednib, the entire organization is laser-focused on ensuring we optimize our ability to bring this important therapy to patients in need, despite the challenges that the coronavirus pandemic may pose. Although this is uncharted territory and things continue to evolve, I want to provide updates on several topics, including what we are hearing from market research regarding the impact of COVID-19 on providers and patients, how we are adapting our launch planning, and our current thinking on how the potential launch of a pregnancy could be impacted. Results from various industry surveys suggest that patient visits across many specialties, including oncology, have decreased compared to pre-pandemic levels.

Does the current buyers pandemic may pose.

Although this is on try to territory and continue to evolve I want to provide updates on several topics, including what we're hearing from market research regarding the impact of covert 19 on providers and patients. How we are adapting our launch planning and our current thinking on how the potential launch of a credit could be impacted.

Daniel C. Martin: Despite this, initial data suggest in oncology, the impact to both new patient starts and overall patient treatment volume may be less than in other specialties. It remains to be seen if the resilience we are seeing in oncology continues as the data mature to more fully reflect the impact of the pandemic. Not surprisingly, in-person interactions between oncologists and sales reps declined dramatically.

Results from various industry surveys suggest that patient visits across many specialties, including oncology have decreased compared to pre pandemic levels. Despite this initial data suggests and oncology the impact of both new patient starts and overall patient treatment volume may be less than in other specialties that remains to be seen.

If the resilience we are seeing oncology continues as the data mature smartfolio reflect the impact of dependent.

Not surprisingly improve any currently interaction between oncologists in sales representatives have declined dramatically. However, oncologists appear to be increasingly opened to virtual engagement through various technology enabled platforms.

Anything unique challenges posed by the pandemic across functional launch team has done an outstanding job adapting our launch preparation and go to market strategies to ensure we optimize our ability to bring were pregnant patients in need pending FDA approval.

We have hired very talented commercial team, including approximately 40 sales representatives with extensive orlen colleges launch experience.

Given our work from home policy, we've converted our entire training program, including our launch me to virtual platforms.

We've modified key go to market strategies in core elements of our plan tactical mix.

This includes developing comprehensive ramon detailing capabilities and increasing our investment in digital and other nonpersonal marketing channels.

Daniel C. Martin: Increasing Our Investment in Digital and Other Non-Personal Marketing Channels. The team has devised and implemented our launch plans without losing focus on the importance of providing disease education to providers and patients prior to approval. In addition to our previously launched provider-oriented website, RethinkGIST.com, we recently launched our patient site, justtogether.com, which provides important education and resources to support patients and caregivers during their treatment journey. We look forward to providing more updates on our launch preparations and core initiatives to support providers, patients, and caregivers in their fight against COVID-19. Our discussions with Jif K. Wells confirm that despite the challenges, things that have not included the high unmet need in the fourth line.

The team devised an implemented these changes to our launch plans without losing focus on the importance of providing disease education to providers and patients prior to approval.

In addition to our previously launched provider oriented web site rethink just dot com, we recently launched our patient site.

Just together dotcom, which provides important education and resources to support patients and caregivers during their treatment journey.

We look forward to providing more updates on our launch preparations and core initiatives to support providers patients and caregivers and their fight against chips.

Our discussions with GSK wells confirmed that despite the challenges of code 19 things that have not changed include the high unmet need in Portland, just their excitement for pregnant and their dedication to providing optimal care for their patients as a result, our view of presence practice changing.

Thomas Patrick Kelly: [inaudible] for Reprentant and their dedication to providing optimal care for their just patients. As a result, our view of recruitment's practice-changing potential for the treatment of GIST has not, nor has our expectation for retinib's mid and long term commercial potential. That said, while we are confident in our revised launch plans, we also recognize that, in the short term, challenges from COVID-19 may slow the rate of, Additionally, it's likely that the increased unemployment rate caused by the pandemic will increase the number of uninsured or underinsured patients, which in turn could drive increased utilization of our patient assistance program. As an organization, we are tremendously excited to potentially launch Deciphera's first I look forward to updating you on our progress. I will now turn the call over to Tucker Kelly, our Chief Financial Officer, to review our financial results. Thanks Dan.

Potential for the treatment of just has not changed nor has our expectation for improvements made in long term commercial potential.

That said, while we are confident in our revised launch plans. We also recognize that in the short term the challenges from cobot 19 may slow the rate of uptake.

Additionally, it's likely that the increased unemployment rate caused by the pandemic will increase the number of uninsured or underinsured patients, which in turn could drive increased utilization of our patient assistance program.

As an organization, where tremendously excited to potentially launch to Cypress first drug this year and are extremely focused on bringing this important treatment option to patients in need I.

I look forward to updating you on our progress in coming months.

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

Thanks, Dan Let me take just a minute to discuss a few highlights our first quarter financial results.

Thomas Patrick Kelly: Let me take just a minute to discuss a few highlights from our first quarter financial results. Importantly, in the current market environment, we remain well capitalized to fund our business as we prepare to potentially launch Pregnant this year. We ended the first quarter with cash and cash equivalents in marketable securities of approximately $691.5 million.

Importantly in the current market environment, we remain well capitalized to fund our business as we prepare to potentially launch for predators. This year. So we ended the first quarter with cash cash equivalents in marketable securities of approximately 691.5 million.

Based on our current plans, we expect that our cash would be sufficient to fund our operations and capex into the second half of 2022.

Thomas Patrick Kelly: Based on our current plans, we expect that our cash will be sufficient to fund our operations and CapEx into the second half of 2022. In the first quarter of 2020, our total operating expenses increased by $1.3 billion to approximately $75.3 million from $49 million in the first quarter of last year, based on increased investments to support our potential commercial launch of Ipretinib, as well as increased clinical development activities across the pipeline. Research and Development expenses were approximately $51.4 million, and selling general and administration expenses were approximately $23.9 million for the first quarter of 2020.

In the first quarter 2020, our total operating expenses increased.

To approximately $75.3 million from 49 million in the first quarter of last year based on increased investments to support our potential commercial launch of accretive as well as increased clinical development activities across the pipeline.

Research and development expenses were approximately 51.4 million.

Selling general and administration expenses were approximately 23.99 for the first quarter of 2020.

We expect our expenses to continue to grow modestly over the coming quarters as we continue to invest in our commercial and clinical activities.

Steven L. Hoerter: We expect our expenses to continue to grow modestly over the coming quarters as we continue to invest in our commercial and clinical activities. And with that, I'll now turn the call back over to Tucker. Thank you. I'd like to take a moment to thank the entire team here at Deciphera for their continued dedication to our mission in the face of adversity as we adapt to these rapidly changing conditions presented by COVID-19. Because of our focus and determination, 2020 will be a transformational year for the company as we await the potential approval and launch of pretinib in the U.S. later this year. We look forward to keeping you all updated as we continue to progress throughout the year. And with that, Frederica, I'd like to open the call to questions. Sure, and your first question comes from the line of Jessica Fye with JPMorgan. Hi, this is Yuka on the call for Jessica.

I'll now turn the call back over to Steve.

Thank you Dr. I'd like to take a moment to thank the entire team here to safer for their continued dedication to our mission in the face of diversity as we adapt to these rapidly changing conditions presented by Covidien team.

Because of our focus and determination 2020 will be a transformational year for the company as we await the potential approval and launch of accretive in the US later this year, we look forward to keeping you all updated as we continue to progress throughout the year and with that Federica I'd like to open the call for questions.

Sure first question comes from the line of Jessica Fye with JP Morgan.

Hi, This is you're going to call for Jessica. Thank you for taking our question.

Unknown Executive: Thank you for taking our questions. Do you expect a pre-approval inspection will still be required prior to an FDA decision on Ropretinib? Has this taken place yet? Yeah, hi, Hugo.

Do you expect a pre approval inspection will still be required prior to an SDK decision I regret Ed has just taken place yet.

Yes, how you go it's Steve Thanks, very much for the question. So we haven't provided any any additional color in terms of the granularity that you mentioned thinking that down to the level of PPA size and the like what I can say is that we continue our very collaborative dialogue with the agency. We're very pleased with the progress and we look forward to the agency.

Steven L. Hoerter: It's Steve. Thanks very much for the question. So we haven't provided any additional color in terms of the granularity that you've mentioned, you know, down to the level of PAIs and the like. But what I can say is that we continue our very collaborative dialogue with the agency. We're very pleased with the progress, and we look forward to the agency taking action on the application by the PDUFA date, which, as you know, is August 13.

Taking action on the application by the PDUFA date, which as you know is August 13th.

Great and and I Love My second question I have how patients enrolled in industry been able to get their scans within that define windows in the study protocol. Despite the pandemic.

Unknown Executive: And as for my second question, I have, have patients enrolled and intrigued been able to get their scans within the defined windows and the study protocol despite the pandemic? Yeah, thanks for the question. We've been working very closely, as Matt mentioned in his prepared remarks with clinical trial sites across all of the trials, including Intrigue. Matt, would you like to provide a little bit more color about the nature of the work that we've been doing with respect to Intrigue specifically? Sure. Thanks, Steven.

Yes. Thanks for the question we've been working very closely as Matt mentioned in his prepared remarks with clinical trial sites across all of the trials, including entry Matt would you like to provide a little bit more color about the nature of the work that we've been doing with respect to treat specifically.

Sure no. Thanks, Steven Thanks for the question so as we indicated due to the pandemic.

Matthew L. Sherman: Thanks for the question. So, you know, as we indicated, due to the pandemic, the FDA has issued guidance for pharmaceutical sponsoring companies to be able to monitor patients, both centrally as traditionally done as well as locally. So we're able to implement those procedures at sites and, you know, feel very confident with the data that's being collected through the entire pandemic. Sorry, through the entire pandemic. Thank you. And your next question comes from the line of Chris Raymond with Piper Pham. Hey, thanks. Just two questions.

The FDA has issued guidance about pharmaceutical sponsoring companies to be able to monitor patients club deal. Both centrally has traditionally gone as well as locally so we're able to implement those procedures at sites and feel very confident with that data that's been collected but through the through the pandemic started through the pandemic.

Thank you.

Thank you next question comes from the line of Chris Reimer with Piper Sandler.

Thanks.

Unknown Executive: I guess, first, it's more of a general sort of commercial question. I know you guys have talked about launch prep, and I would imagine you're not interested in giving us too much detail, but, you know, The Voyager miss, you know, I think was a pretty big deal. In that you now have this market essentially to yourself in terms of kit inhibitors, so I guess. Can you give any more color about how this changes your commercial picture? Obviously, having one less competitor is good.

Just two questions.

I guess first.

It is more of a general sort of commercial question you guys talked about launch prep.

And.

I would imagine you're not interested in getting us too much detail, but.

The Voyager.

Miss.

I think was a pretty big deal.

And that you now have this market essentially to yourself in terms of.

Kit inhibitors, so I guess.

Can you give any more color about how this change this year.

Your commercial picture, obviously, having one less competitors is good.

But can you talk a little bit about how you are issued restructuring the field force differently if at all in.

Steven L. Hoerter: But can you talk a little bit about how you are sort of structuring the field force differently, if at all, in terms of the go-to-market approach? I mean, obviously, you know, you've got to get out there for a small subset, but just, you know, in terms of the broader population. And then, you know, maybe secondly, just in terms of the entry study, can you just remind us what the bar for success in that study was? I think you've talked about two to three months increase over SUTN. Um... Can you just reaffirm that and just sort of talk about what we should be looking for? Thanks. Hey Chris, it's Steve.

And sort of the go to market approach.

Obviously.

You got to get out there first of all subset, but just in terms of the broader population.

And then.

Maybe secondly.

Just in terms of the interim.

Entry study can you just remind us what's the bar for success.

And that study I think you've talked about two to three months increase overseas.

Can you sort of just reaffirm that just sort of talked about what we should we look for thanks.

Hey, Chris It's Steve So let me take the second part of your question first and then I'll start off addressing your other question about Voyager and turn it over to Dan Martin into the offer some additional color on from a commercial point of view. So so far with respect to entry you're right in terms of the study versus.

Steven L. Hoerter: So let me take the second part of your question first and then I'll start off addressing your other question about Voyager and then turn it over to Dan Martin to offer some additional color from a commercial point of view. So first, with respect to Intrigue, you're right, in terms of the study versus Sutent, we would expect Sutent to offer about six months of PFS, and that's consistent, I think, whether you look at the drug label or whether you look at other published studies with Sunitinib or Sutent. And so we would expect that a two to three month improvement in progression-free survival over Sunitinib would be a favorable study. And we haven't provided any additional detail in terms of powering assumptions and the like.

Seats, and we would expect just do tend to offer about six months of PFS.

And Thats consistent I think whether you look at the drug label or whether you look at.

At other published studies with Signet never Sutent and so we would expect the two to three month improvement of progression free survival over Sunitinib would be would be favorable study and we haven't provided any additional detail in terms of powering assumptions and the like.

Steven L. Hoerter: With respect to your first question about Voyager, I mean, first of all, it's certainly disappointing news, I think, for the GIST community, to have a negative study in this disease. As you know, this is a group of patients in a community that's really been waiting for new options for patients. And I think the data that we saw from Voyager certainly puts that in context.

With respect to your your first question around Voyager I mean, I think first it's certainly disappointing news I think for the just community.

Had a negative study in this disease as you know this is a group of patients.

And a community that's really been waiting or new options for patients and I think the data that we saw from Voyager certainly puts in context, the potential for repressed NIM in the Invictus study that we presented last year, whereas you know we chose for the primary endpoint in 85% reduction in the risk of.

Daniel C. Martin: The potential for repretinib in the INVICTUS study that we presented last year, where, as you know, we showed for the primary endpoint an 85% reduction in the risk of progression or death. So, you know, I think it does show that repretinib has the real potential to be best in class in this disease. So now I'll turn it over to Dan. Martin, do you want to offer any additional comments in terms of the commercial context? Sure. I think you framed it really well, Steve. I was just going to say that I really think that the Voyager outcome serves to really validate our long-held view of really the core value proposition, the core clinical value proposition for pregnant women in GIST. GIST is a very heterogeneous disease from a mutational perspective.

Russian event. So I think it does does showed that the recruitment has the real potential to be best in class in this disease. So now I'll turn it over to Dan Mark that you want to offer any additional comments in terms of commercial contracts.

Sure.

Thank you framed it really well, Steve I was just going to save that I really see that.

On the boys your outgrown serves to really validate our long held view of really the core value proposition core clinical value proposition for for printing and ingest just is a very heterogenous genetic disease through mutational perspective and.

Daniel C. Martin: And, you know, I think this really underscores the need for a broad-spectrum inhibitor like Repretinib. That's really been the strategy all along and why this drug was designed specifically for GIST. So we've always viewed Repretinib as the drug with real practice-changing potential, certainly in the fourth line and hopefully down the road beyond that. So in terms of your question, www.youtube.com or the link in the video description, change our strategy.

I think it's really underscores the need for a broad spectrum inhibitor.

Mike regret and really been.

The strategy all along.

And why this drug is designed specifically for just.

So we've always knew retinal that really.

The drug with real practice changing potential.

Certainly in the fourth line and hopefully down the road beyond that.

So in terms of your question about is it leading us to change our.

Salesforce size or structure that sort of thing.

The larger result, if not we don't do that.

Rationale due to change our strategy.

So.

Full steam ahead.

Steven L. Hoerter: So, full steam ahead. Okay, one more follow-up if I can. So, it's another general question, but if you look at analogs of FDA's Approval Cycle for other RT or designated oncology compounds, you would assume that, um... Your August PDUFA date might be, you know, outside the norm of what they generally approve. If it comes earlier, including, you know, much earlier, are you ready regardless? Uh, to launch. Yeah, Chris. It's Steve.

Okay, one more follow up if I can so.

Another general question, but.

Look at analogs of Fts.

Approval cycle for other Archie are.

Designated oncology compounds.

Yeah, one would assume that that.

Your August PDUFA date might be.

Outside.

The norm of what the with it generally approved.

If it comes earlier.

Including much earlier are you ready regardless.

To launch.

Yeah, Chris It seems so it's a good question in your right. When you look at the analog whether if you look to drugs that have received breakthrough therapy designation as Rick has or you look at the handful of drugs that have been reviewed under our tour you're right. I think generally speaking those reviews tend to conclude earlier than the PDUFA date, and so our team internally.

Steven L. Hoerter: So it's a good question. And you're right, when you look at the analogs, whether you look at drugs that have received breakthrough therapy designation, as RepretNet has, or you look at the handful of drugs that have been reviewed under RTOR, you're right, I think, generally speaking, those reviews tend to conclude earlier than the PDUFA date. And so our team internally has been working really hard to be ready for what we would view as a reasonably accelerated timeframe, recognizing, of course, that it's up to the FDA in terms of the timeline and how they choose to act on the application up to the point of the PDUFA date. But we're really comfortable with our level of preparedness, as I mentioned in the prepared remarks, from a commercial supply perspective, we feel like we're And Dan and his team and Matt on the medical affairs side, I think they've done a really nice job building superb teams but also doing all the heavy lifting to be ready for a potential early approval should that happen. Great, thanks a lot. And your next question comes from the line of Eun Yang with Deaf. Thank you.

That's been working really hard to be ready for what we would view as a reasonably accelerated timeframe recognizing of course that it's up to the FDA in terms of the timeline, which they choose to act on the application to the point of the PDUFA date, but we're really comfortable with our level of preparedness as I mentioned in the prepared remarks from.

Commercial supply perspective, we feel like we're in good shape, there and Dan and his team and that on the medical Affairs side, I think I've done a really nice job a building super teams, but also doing all of the heavy lifting to be ready for a potential early approval should that come.

Great. Thanks, a lot.

Thank you next question comes from the line of on Yang with Jefferies.

Steven L. Hoerter: So Steve, as you pointed out, the pandemic impact is uncertain and it's fluid. Yet, you are maintaining your clinical timelines, including phase III intrative studies. So my question to you is, is there something that you are seeing giving you such confidence, or is it purely based on your expectation of a short-term impact such that you can catch up later? Yeah, Eun.

Thank you Steve as you pointed to how does that make high impact Isa content any to slowly.

You are maintaining.

Okay timeline to including CG thinking changes study.

So.

Question on Tuesday, you said is that something that you are seeing keeping your such a confidence some more.

Is it purely based on your expectation all the short term.

Impacts such as you can catch up nadir.

Yes units Steve. Thanks for the question. It's a good question we've been getting questions similar to this as you can imagine from investors over the course of the last month or two.

Steven L. Hoerter: Thanks for the question. It's a good one. We've been getting questions similar to this, as you can imagine, from investors over the course of the last month or two. So, as you point out, the impact of the pandemic is, you know, inherently uncertain. So, you know, we're not, you know, we don't have any additional insight, you know, aside from what we shared in the prepared remarks, which is that our guidance is predicated on this having a shorter-term impact, as opposed to a longer-term, fully disruptive impact. But based on the number of clinical trial sites that we have open, based on the number of countries now in which we're operating with Intrigue, And so to the extent, you know, we need to change that guidance, we will, of course, do so, and we'll update investors at that time.

So as you point out the impact of the pandemic is inherently uncertain. So we're not.

We don't have any additional insight aside from what we shared in the prepared remarks, which is we believe in our guidance is predicated on this having a shorter term impact as opposed to a longer term fully disruptive impact, but based on the number of clinical trial sites that we have opened based on the number of countries now in which we're operating.

With intrigue and based on what we see in terms of enrollments in the study that all gave us comfort in the reiterating our guidance to have intrigue enrolls by the end of the year.

And so to the extent, we need to change that guidance. We of course will and we'll update investors at that time, but based on listen view at the moment, we're comfortable with the reiteration of our guidance as to the entry enrollment.

Steven L. Hoerter: But based on what's in view at the moment, we're comfortable with the reiteration of our guidance as to Intrigue enrollment. Okay, and then, in terms of the 19% increase in the total number of patients to be enrolled in Intrigue of Age 3, has that been signed off by the FDA? Thank you for the question. So we're comfortable now announcing what that N is, as we did, as Matt did in his prepared remarks, an N of 426 in Intrigue.

Okay, and then in terms of a 19% increase into the number of patients to be enrolling in train collegiate Disney has that been signed off by the FDA.

Yes. So we were done thanks, you answer the question. So we're comfortable now announcing what that and is as we did as Matt did in his prepared remarks, and 426 and intrigue so were formally.

Steven L. Hoerter: So we've formally initiated the amendment process for the study and are getting that information pushed out to clinical trial sites. So, yes, that is the new N for the Intrigue study. We're looking forward, as I noted, to getting the study fully enrolled by year end and then reporting that out when the time is right. Thanks, and my last question is about orcokinase inhibitors. So the IND filing is on track for the second half of this year. So obviously, it's very early, but given the target, is it reasonable to assume that the cancer types that you may go after are like pancreatic, lung, and colorectal cancers with a high frequency of RAS mutation? Yeah, you know, I think that's right. So yes, you know, you noted the tumor types that have a high frequency of mutant RAS. And so those would be obvious tumor types for us to consider pursuing. But we haven't yet disclosed which tumor types we will pursue.

We have initiated the amendment process for the study and getting that information pushed out to clinical trial sites.

Yes, so with that is the new and for the and treat studying we're looking forward as I noted to getting the study fully enrolled by year end and then reporting that out.

When when the time is right.

Thanks, and then my last question is on Arca kinase inhibitor. So I am be filing is on track for second half of this year. So obviously, it's a very early but.

Given the target.

Dave reasonable to assume that.

To cancer testing you may go after our lack of pancreatic lung and colorectal cancer with a high frequency other asking mutation.

Yes, I think thats right. So yes, you noted the tumor types that at a high frequency in Raza. So those would be obvious tumor types for us to consider pursuing we haven't yet disclosed what tumor types. We will will pursue we'll get to that later as we get the drug into the clinic and and are able to articulate.

Unknown Executive: We'll get to that later as we get the drug into the clinic and are able to articulate further what the development path may be and specifically what tumor types we might select. But certainly, we would consider moving into tumor types where there's a high frequency of mutant RAS. Thank you very much, on the line for Peter Lawson. Hey guys, this is Waleed Al on behalf of Peter.

Further what the development path, maybe and specifically with tumor types, we might select but certainly we of course would consider moving into tumor types, where there is a high frequency in the address.

Thank you very much.

Thanks you.

Your next question comes from the line of Peter Lawson with Barclays.

Hey, guys. This is what lead on for Peter Thanks for taking my questions.

Unknown Executive: Thanks for taking our questions. I just had a question, sort of a follow-up as to an earlier question on your market strategy. Just wanted to ask, you know, whether your thoughts have changed on pricing now, especially after the Voyager failure, and how you're thinking about that going forward? Yeah, thanks for the question. So I'll start off, and then I'll turn it over to Dan to offer some additional color.

Just had a question sort of follow up those two to an earlier question on your market strategy in advance just.

Thanks.

Wanted to ask whether your thoughts have changed on pricing now, especially after the Voyager failure.

And how you're thinking about that.

Going forward.

Yes. Thanks for the question. So I'll start off and then I'll turn it over to Dan to offer some additional color I guess, what I'd say is that this is premature for us to talk about potential price for refresh. So we would do that upon a potential approval of the drug and we'd be in a position to talk about then I will offer that we.

Steven L. Hoerter: I guess what I'd say is that, you know, it's premature for us to talk about the potential price for repretinib. So we would do that upon the potential approval of the drug, and we'd be in a position to talk about it then. You know, I will offer that we've done a considerable amount of market research with payers to get their reaction and to understand their perspective on the profile of repretinib based on the Invictus data. Dan, perhaps you'd want to offer some additional color in terms of what we hear from both physicians and payers. Sure. Thanks, Steve. So, that's a good question.

Done a considerable amount of market research with payers to get their reaction to understand their perspectives on the profile of were threatened based on the Invictus data and Dan perhaps you'd want to offer some additional color in terms of what we hear from both physicians, but also compares.

Sure. Thanks, Steve.

Daniel C. Martin: We, the research that we've done with a number of stakeholders, obviously payers being central to that, has really, very clearly shown us that payers appreciate not only unmet need and gist but the, you know, potentially best-in-class profile for RepredNib. And so, you know, we, the methodology you use in those studies, as you may know, certainly review the approved therapies in the class and their prices and their profiles as well as our own profile. And what continues to come back is that payers really appreciate how this drug may be able to help patients. So, as Steve said, it's premature for us to comment on pricing, and we'll be doing so, you know, in due time on approval. I got it. Thank you so much.

So good question, we the research that we've done.

With the numbers stakeholders, obviously payers being central to that.

Has really very clearly.

Shown us the payers appreciate.

Not only unmet need and just but the potentially best in class profile for.

Refreshment and so we.

Methodology use enough studies as you may know certainly.

We review the approved therapies in the classroom and their prices and their profiles as well as our profile in what continues to come back is just that Theres really appreciate how this drug may be able to help patients. So as you said, it's premature for us to comment on pricing.

And we'll be doing so.

And do in due time on approval.

Got it thanks, so much lesser Alcoans just a question on your programming TGC.

Unknown Executive: That's really helpful. And just a question about your program and the TGCT. Maybe you can provide us with some color on your differentiation between your drug and pexidartanib. And, you know, as we look at the data and second half, what would be the bar there? And, you know, what would you consider to be a win?

Maybe if you can provide us some color on.

Your differentiation between your drug in Texas, Darted Theyve been as we look to the data in second half what would be the bar there and what you would consider to be a win.

Yes. Thanks for the question on 30 14, so so maybe I'll start off and then Matt can add some additional color if you'd like to so.

Steven L. Hoerter: Yeah, thanks for the question on 3014. So maybe I'll start off, and then Matt can add some additional color if you'd like to. So, you know, when we look at 3014 relative to the other approved agent to treat this disease, you know, I think that the things that come to mind for us in terms of distinctions between the two programs are that 3014 is highly selective for the target. So this is a very potent and selective CSF1R inhibitor. And pexidartanib, we know, as Matt referenced in his prepared remarks, is a multikinase inhibitor that hits a variety of targets, including CKIT, and FLT3.

When we look at that 30 14 relative to the the other.

Proved agent to treat this disease I think the things that come to mind for us in terms of distinctions between the two programs.

Our the 30 14 is highly selective for the target. So this is a very potent and selective CSF one our inhibitor in Texas are you know as Matt referenced in his prepared remarks is a multi kinase inhibitor that hits a variety of targets, including Sicad, including flipped three and this is also a drug that.

Steven L. Hoerter: And this is also a drug that, upon review, as you know, may recall, it was referred to an ODAC for a discussion about risk and benefit. And the drug was ultimately approved, but with a REMS and a black box warning for hepatotoxicity. And this is a dose of the drug that is a relatively high drug load in the range of 800 milligrams daily for patients.

Fund review as you know may recall that was referred to in ODAC for a discussion about risk benefit in the drug was ultimately approved but with a rems and a black box warning for hepatic toxicity and it's a dose of drug that is a relatively high truckload in the range of 800 milligrams daily for patients. So we believe that there is there is room.

In this disease setting for a more potent and selective agent.

Matthew L. Sherman: So we believe that there is room in this disease setting for a more potent and selective agent that has an attractive efficacy as well as safety profile for these patients. And we're looking forward to continuing to generate additional data with 3014 in patients with TGCT. Matt, do you want to comment a little bit on that or on additional data that may be coming in the second half of this year? Yeah, no, so yeah, you know, so again, clearly, the distinction between the safety profiles is, you know, maybe a very important aspect of treating this disease because, as we recognize, you know, this is, you know, it's a locally addressed disease, but it's not a malignant disease. Although not generally life threatening, they certainly can be associated with very severe morbidity, pain, swelling, and limitations of activities.

It has a an attractive efficacy as well as safety profile for these patients and we're looking forward to continuing to generate additional data with 30 14 in patients with TGC, Matt do you want to comment a little bit on on that or on additional data that may be coming in the second half of this year.

Yes, no. So yes, so again clearly the distinction between 60 profiles, maybe a very important aspects of treating this disease because as we recognized this is.

So locally aggressive disease, but it's not a malignant disease, so not generally life threatening.

Certainly can be associate with very severe morbidity.

I mean swelling limitations of activities. So tolerable drug is really probably wouldn't most important characteristics along with an efficacious drug and the pet and garden that blends forming and certainly.

Matthew L. Sherman: So a tolerable drug is really probably one of the most important characteristics along with an efficacious drug and the pexidartan and rems form, and certainly, you know, restricts its use under the FDA program. So just referring back to the data that we did present for the first three patients, we were able to show that not only did we have, you know, a good safety profile in the data that we presented at the CTOS meeting last year, but the first three patients that we enrolled all had initial reductions in their tumor volume. And the first patient who was on the longest had a 48 percent reduction. After two cycles, and then after nine cycles of therapy, they had an 84% reduction in their tumor size.

Restricts its use.

On to the FDA program.

So just referring back to the data that we did present for the first three patients.

We're able to show that not only because we have good safety profile in the data we presented could see talks meeting last year, but the first three patients that we enrolled you all had reductions.

General and Dr. reductions in their tumor volume and the first patient who is on the longest had 48% reduction.

After two cycles and then after nine cycles of therapy had an 84% reduction in their tumor size. So again.

Matthew L. Sherman: So again, you know, important early data that we believe can differentiate us from pecs and tartanib. And as we also said in our prepared remarks today, we continue to plan to have data to update folks by the end of this year from the ongoing phase one, two study. Got it.

And our early data.

We believe can differentiate us from Pixie Gartner and as we also said in our prepared remarks today. We're continue we plan to have data to be able to update.

Folks, but into this year from the ongoing phase one two study.

Thank you to have any clarity on the potential regulatory path forward for 30 14.

Unknown Executive: Thank you. Do you have any clarity on the potential regulatory path forward for 3014? Yeah, no, I think it's, you know, for us specifically, it's probably too early to, you know, talk about a regulatory path forward for 3014. But clearly, you know, the development of PEXI-DART NIP did establish at least the FDA's perspective on what they were looking for in terms of response rate. Importantly, also, you know, functional outcomes, or PROs, were also a big part of the ODAC discussion for the approval of PEXI-DART NIP. It's certainly, you know, something that we should be, and we will be considering for our development program. Tyler, thank you so much for taking the questions. Your next question comes from the line of Michael Schmidt. Hey guys, this is Charles Zhu on behalf of Michael Schmidt.

Yes, I think its first specifically, it's probably too early to.

Talk about regulatory regulatory path forward.

Further the 14, but clearly the development of pixel starting to establish leased third we have to his perspective on what what they were looking for in terms response rate.

Importantly, also functional outcomes are pirow square as well so a big part of the ODAC discussion.

For the approval, we'll pick sungard and that's the certainly something that we should be that will be considering for development program.

Got it. Thank you so much for taking the questions.

Your next question comes from the line of Michael Smith doesn't.

Hey, guys. This is Charles do on for Michael Schmidt, Thanks for taking the questions and congrats on all this progress.

Steven L. Hoerter: Thanks for taking the questions and congrats on all this progress. One quick one, swinging back to Repretnib, what are your high-level plans, or how has your thinking for commercializing Repretnib evolved with respect to the ex-US, as well as outside of greater China? And if you decide to go and partner on this drug, how should we think of the economics for Deciphera, given that the Zylab collaboration was signed before Invictus, and now you obviously have much more data? Hi Charles. It's Steve.

One quick one of switching back to refresh what are your high level plants or how has your thinking for commercializing reprint nimble ball with respect to ex us as well as outside of greater China, and if you decide to go and partner out this drug how should we think of economics for decipher up.

Given that the xylem collaboration was signed before and victims and now you obviously have much more date data.

Yeah I Charles it's Steve Thanks for the question. So as you know, we said that one of our key milestones for the year is filing the marketing authorization application with the European Medicines agency in the second half of this year. So we're looking forward to engaging with with the European regulator.

Steven L. Hoerter: Thanks for the question. As you know, we said that one of our key milestones for the year would be filing the marketing authorization application with the European Medicines Agency in the second half of this year. So, we're looking forward to engaging with the European regulator on the package for PRETINENT and getting that review process started. We haven't provided any greater detail in terms of what our path might be to commercialization in Europe, or what our go-to-market strategy might be in Europe. What I have said is that there are two different options that we are evaluating. One is the potential for us to go it alone in Europe and to build a capital-efficient structure to commercialize PRETINENT on our own. And the alternative to that, of course, would be to pursue a potential licensing transaction.

On the package for credit and getting that review process started we haven't provided any greater detail in terms of what our path might be to commercialization in Europe, what our go to market strategy might be in Europe, but I have said as there are two different options that we are evaluating one is the potential for us to go it alone in Europe in Sybil.

The capital efficient structure to commercialize the threatened about our own any alternative to that of course would be to pursue epicentral licensing transaction.

Got it okay and shifting over to real fast unit.

Steven L. Hoerter: Got it. Okay. And shifting over to Ribastinib, as you evaluate type 2 inhibition in conjunction with either Paclitax or Carboplatin, is there any reason to believe that the drug may perform differently between these two combinations, either from a drug mechanistic perspective or from a disease biology perspective, given they may go into different tumor types? Yeah, it's a good question, Charles. I'll ask Matt to take that question

As you evaluate tied to in addition in conjunction with other Patla tax lot of cargo flattened is there any reason.

To believe that is roughly performed definitely between these two combinations either from a drug mechanistic perspective, or a disease biology perspective, given there they may go into different tumor types.

Yes, it's a good question Charles I'll ask Matt to take that question Matt.

And our thanks. Thanks for the question. So there's been a fair amount of preclinical data that's been done to look at the combination and actually there's been different combination partners have been studied with.

Matthew L. Sherman: And thanks, you know, thanks for the question. So yeah, there's been a fair amount of preclinical data that's been done to look at the combination. And actually, there's been different combination partners that have been studied, you know, with the ribacinib, the top two kinase inhibitors. And what we've shown that with different combinations, we are able to have this, you know, Inhibitory Effect. I think the distinction may come from the Tumor Indications that will be developed because paclitaxelin is part of a plurinibus. Perhaps differently, for different indications, so a selection of a particular tumor, a selection of a particular combination would be applicable to which tumor will be, you know, will be targeted. Got it.

Regressive at the time to kinase inhibitor.

And what we've shown that with different combinations, we are able to have this.

It's.

Inhibitory effect I think the distinction may come from the.

Tumor indications that will it developed because paclitaxel and are hopeful and ideas.

Perhaps differently for different indications, so selection that particular tumor, but the selection that particular combination will be applicable to which tumor will be.

We will be targeted.

Got it thanks for taking the questions.

Unknown Executive: Thanks for taking the question. You bet. Thanks, Charles.

Hey, guys. Thanks Charles.

Your next question comes from the line of Robyn Karnauskas with Suntrust.

Steven L. Hoerter: And your next question comes from the line of Robin Cronkite. Hi, guys. Thanks for taking my question. There are two of them.

Hi, guys. Thanks for taking my question two of them one I'm sure you've heard a lot, but I can we just we need to go through it again.

Steven L. Hoerter: One, I'm sure you've heard a lot, but I'll give you the big picture: if you have a competitor out of the way, that presumably means you'll get more revenue. You know, what does that mean for your company? That's more of a bullish scenario, maybe than you originally contemplated. So how do you put that money to work in the long run?

Big picture you have a competitor out the way that presumably means you'll get more revenue.

Steven L. Hoerter: And then second, just a question, I'm sure you hear all the time, let's deal with it. Obviously, I've seen other drugs do better in the real market than they do in their clinical trials. So does SUTN do better after a few years in the market? So would SUTN data look better today than it did when it launched? So that goes to the point in which you said there's a two to three month difference between SUTN on second line and PFS. Would that be enough to get stats?

What does that mean for your company that's more of a bowl scenario meeting you originally contemplated so how do you put that money to work in along right.

And then second just a question Im sorry, Hurlbutt handling deal with it on obviously.

We've seen other drug to better in the rail market than they do enter clinical trials. So that it will do better after a few years in the market. So it's Steven data look better today than it did when it launched so that goes to the the powering which extended the two to three much different from it and in second line, a PFS and would that be enough to get that.

Steven L. Hoerter: I think that's a concern some investors have. Yeah, Robin, thanks. It's Steve. Let me take those two.

I think that the concern for investors tab.

Yeah, Robyn. Thanks. It sees let me let me take those too so the ill start with the second question first with respect to Sunitinib.

Steven L. Hoerter: So, I'll start with the second question first with respect to Sunitinib. So, as you know, when you look at the Sunitinib label and the data that was generated that was the basis for approval, the PFS seen with Sutent was shy of six months in that pivotal study. And when you look at the literature, you, of course, see a range of different PFS estimates depending on the study, some very small studies, some larger studies that have been done, but they tend to coalesce generally around the six-month PFS range.

So as you know when you look at the Sunitinib label and the data that was generated that was the basis for approval. The PFS seamless Sutent was just shy of six months and that pivotal study and when you look at the literature, you foresee a range of different PFS estimates depending on the study and has some very small study some larger studies that have been done.

But they tend to coalesce generally around the six month PFS range and in fact this as you can imagine was an important input for us when we were designing the tree study to try to understand how sutent might perform in the current environment versus.

Steven L. Hoerter: And, in fact, this, as you can imagine, was an important input for us when we were designing the Intrigue study to try to understand how Sutent might perform in a current environment versus, you know, at the time when the original study was done. And from our discussions with thought leaders around the world, very consistently, the group of thought leaders that manage patients with this disease came back and said that, yes, six months is the right sort of expectation in terms of how Sunitinib might perform in the present day in the second-line setting. So, we feel very comfortable with that estimate.

In that in the time when the original study was done and from our discussions with thought leaders from around the world very consistently bigger for thought leaders that did manage patients with this disease came back and so the six months has the right sort of expectation in terms of how sunitinib might perform in the present day in the.

Second line setting so we feel very comfortable with that estimate and then as you know our phase one study, where we had a second line cohort of patients. So at the recommended dose of 150 milligrams once daily.

Steven L. Hoerter: And then, as you know, in our Phase I study, where we have a second-line cohort of patients, so at the recommended dose of 150 milligrams once daily, which is an N of 31, we have seen a PFS in that patient population of about 10.6, 10.7 months. So with the data, of course, now that's been generated with Invictus in the fourth line population, gives us great confidence in the potential for Repretnib to perform in the intrigue study versus Sunitinib and to establish a new standard of care in that line of therapy. So with respect to your first question, and this is coming on the heels of the Voyager study failure where Avipritinib underperformed regorafenib in that study. And as I mentioned earlier in the Q&A, while it's certainly disappointing news for the GIST community that has been waiting for new options for patients, I think it does help to put in context, of course, the data that we've generated with Invictus and, I believe, firmly signals and establishes that repregnant has the potential to be best in class in this setting and to be a new standard of care.

Which is an end of 31, we have seen a PFS in that patient population of about 10.6 10.7 months. So that with the data of course now that's been generated with Invictus in the fourth line population gives us great confidence in the potential for refresh to perform in the and treat stuff.

The versus Sunitinib and to establish a new standard of care and that line of therapy.

So with respect to your first question in this is coming on the heels now with the Voyager study failure were able to Britain underperformed director acid in that study and as I mentioned earlier in the queue in a while it's certainly disappointing news for the just community that has been waiting for.

New options for patients I.

I think it does help it does put in context of course, the data that we generated within Victus and I believe firmly.

Signals and establishes the refresh and has the potential to be.

Best in class in this setting.

And to be a new standard of care and so we look forward to engaging with physicians upon a potential approval sharing the data with them for those physicians that aren't already familiar with the invictus data and hopefully benefiting patients with reprinting who are in need of additional options.

Steven L. Hoerter: And so we look forward to engaging with physicians upon a potential approval, sharing the data with them for those physicians that aren't already familiar with the Invictus data, and hopefully benefiting patients with relapse who are in need of additional options. Oh, and my first question about, you know, your competitor is gone. Obviously, this has to change how you think about strategy at the company and how to have a good day. I'm giving you more flexibility to do other things that you want to do. Any thoughts on that?

Hi, My first question about.

Competitors Dod yes.

Obviously this has to change like how do you think about strategy at the company had to be a good day.

And give you more flexibility do other things you want to do any thoughts on that.

Well I think Robyn certainly it's a it's a clearing of that and I think thats, how investors view it as well with the failure of the Voyager study from our point of view redesigned represented specifically to address the spectrum of mutations that drive this disease and are in going assumption all along has been that were threatening.

Steven L. Hoerter: Well, I think, Robin, you know, certainly, it's a clearing of that. And I think that's how investors view it as well, with the failure of the Voyager study. From our point of view, we designed Repretinib specifically to address the spectrum of mutations that drive this disease. And our initial assumption all along has been that Repretinib would prove to be best in class in this setting and this disease. And so at some level, of course, while you're, you know, it's helpful to see final data that that data confirms what our initial set of assumptions were in terms of how Repretinib is truly best in class here. So, you know, we look forward to continuing to explore the role of Repretinib in other settings in GIST to see where it may be able to benefit patients beyond the intrigue study in the second line.

With proved to be best in class in this setting in this disease and so at some level of course, while you're it's helpful to see final data.

That that data confirms what are in going set of assumptions were in terms of how were pregnant.

Steven L. Hoerter: So that includes looking at the frontline setting, whether it be monotherapy or in combination with other agents. We certainly think there are additional places that we can go with Repretinib in GIST, and we look forward to exploring that further and initiating additional studies potentially in the future. Okay, thank you. And your next question comes from the line of Chris. [inaudible] Hello, this is Jackson Harvey on behalf of Christopher Mirai.

Is truly best in class here. So we look forward to continue to explore the rollover printed and other settings, and just to see where with print and it may be able to benefit patients beyond the intrigue study in the second line. So that includes looking at the frontline setting whether it be in monotherapy or a combination with other agents over.

We think there are additional places that we can go with refreshing that ingest and we look forward to two exploring that further and initiating additional studies potential in the future.

Okay. Thank you.

Your next question comes from the line of Chris Drama, Christopher Marai with Nomura Instinet.

Hello. This is Jackson Harvey on for Chris to Primorye. My first question is when the repressed net launched does get underway what kinds of launch metrics do you plan on sharing where we'd be able to get any color on with which line of therapy. The patients are out.

Steven L. Hoerter: My first question is, when the reprentinib launch does get underway, what kinds of launch metrics do you plan on sharing? Will we be able to get any color on which line of therapy the patients are on? Hey, Jackson, it's Steve.

Hey, Jackson assays. Thanks for the question, Yes, a little early for us to share what launch launch metrics would be for pregnant. So once we get on the other side of a potential approval, we'll start to share how we're going to be tracking performance of recruitment in the marketplace and we will share some of that information.

Steven L. Hoerter: Thanks for the question. Yeah, it's a little early for us to share what the launch metrics would be for Repretnib. So once we get on the other side of a potential approval, we'll start to share how we're going to be tracking performance of Repretnib in the marketplace, and we'll share some of that information with investors.

As investors.

Got it and my other question is on where best to NIM.

Steven L. Hoerter: And my other question is on ribastinib, around the muscular weakness side effects. So at the 50 milligram dose, are you able to dose through this side effect, meaning that the muscular weakness will get better with continued dosing? Or is it something that patients need to discontinue treatment for? Also, does that have any cardiac ramifications?

Around the muscular weakness side effects. So at the 50 milligram dose are you able to dose through this side effects, Ed meaning that the muscular weakness will get better with continued dosing or is it something that patients need to discontinue treatment for also it does.

That have any cardiac ramifications. Thank you.

Yes. Thanks, Thanks, Jackson, so I'll turn that over to Matt if you'd like to answer that question Matt.

Steven L. Hoerter: Thank you. Yeah, thanks. Thanks, Jackson.

Sure. So no. Thanks for the question. So what we've reported previously in the Paclitaxel. We've got some combination study was the initial phase one two study was dose ranging Chris 60, and 100 milligrams of investment the I'd and that setting that we.

Matthew L. Sherman: So I'll turn that over to Matt, if you'd like to answer that question. Sure, so thanks for the question. So, you know, what we've reported previously in the Paclitaxel, the BASIM combination study, was, you know, the initial phase one, two study was dose ranging across 50 and 100 milligrams of the BASIMID BID. And in that setting, we saw, you know, fairly equal and lower rates of muscular weakness in those two cohorts.

But saw fairly equal and lower rates of muscular weakness in those two cohorts. When we started the extension of course with 150 milligram the I'd and we did see some on.

Matthew L. Sherman: When we started the expansion course with 150 milligrams BID, we did see some... a few more cases at 100 mg BID, so we modified the dose down to 50 mg BID, which is what we just discussed today as well for the carboplatin combination study. When those patients are discontinued, they can actually recover fairly quickly from their muscle weakness. However, really, for longer-term treatment, we felt that the 50 mg BID dose level was a more tolerable dose level, and this is really in the background, the fairly robust activity that we saw in the paclitaxel combination study with eight partial responses across those two dose levels. This is peripheral muscle weakness.

A few more cases, a 100 milligrams guarantee so we modified the dose down to 50 milligram city, which is what we just discussed today as well for the Carboplatin and combination study when those patients or discontinue they actually can recover really quickly from the muscle weakness however, really for for longer term treatment built at the 50.

Milligram be I'd dose level.

As a more tolerable dose level and this is really on the background the fairly robust activity that we certainly.

In the Paclitaxel combination study with a partial responses across those two dose levels.

This is not this is peripheral muscle weakness is not associated with cardiac.

Matthew L. Sherman: It is not associated with any cardiac muscle effects. Got it. And is there a mechanistic basis to expect that cardiac muscle would not be affected? Yeah, but we haven't really talked about any specific mechanism that could be associated with this. So that would certainly be, You know, a conversation perhaps as we go forward with the development program, but there's no known target that we can identify that would, you know, make us believe that the cardiac muscle is involved. Great, thanks for taking the question. And your last question comes from the line of Orlando Lee with Canon Corp. When your line is open, our line, Sorry.

And the cardiac muscle effects.

Got it and is there a mechanistic basis to expect that cardiac muscle would not be affected.

Yes, we haven't really talking about any specific mechanism that could be associated with this so that would certainly be.

You know a conversation perhaps as them as we go forward with the development program, but there is no known targets that we can identify that would make us believe that the cardiac muscle is involved.

Great. Thanks for taking the questions.

And your last question comes from the line of Arlinda Lee with Canaccord.

And your line is open Orlando only.

Sorry, I was on it.

Unknown Executive: I wanted to follow up on the intrigue. Um, you mentioned previously that it was due to, um, wondering if COVID would be given to you. If you put any other assumptions within that and how, I was curious about your interactions with your thought leaders and salespeople with prescribers at Howell. Yeah, hey, Linda, it's Steve.

I wanted to follow up on the intrigue population increase.

You mentioned previously that due to early censoring wonder you.

Given co bid and maybe some of the.

If you put any other assumptions within that and how the pairing may or may not have changed.

And then secondly.

We're curious about your interactions with your thought leaders sale.

With prescribers that how this might have been different now with Covidien following.

The interpret tonnage wager failure. Thank you.

Yes, Hi, Linda Steve. Thanks, Thanks for the two questions. So maybe what I'll do is ask Dan Martin to take the first question in terms of what we're hearing from thought leaders and from some of the secondary research that he referenced in the prepared remarks in the context of cope with 19 and then we can we can come back.

Steven L. Hoerter: Thanks. Thanks for the two questions. So maybe what I'll do is ask Dan Martin to take the first question in terms of what we're hearing from thought leaders and from some of the secondary research that he referenced in his prepared remarks in the context of COVID-19. And then we can, we can come back, and I can answer the question with respect to intrigue, and that can offer some additional color. So Dan.

And I can I can answer the question with respect to intrigue and Matt Canal for some additional color.

So Dan.

Sure. Thank Steve So couple of thoughts.

Daniel C. Martin: Sure. Thanks, Steve. So, a couple of thoughts. You know, we have been continuing to engage thought leaders and the medical community, the GIST prescribing community more broadly, very actively over the last several months as the COVID-19 situation has developed. We've continued to hold advisory boards. We've continued to have our one-on-one discussions.

We have been continuing to engage.

Thought leaders in the medical community that just prescribing maybe more broadly very actively over the last several months as the covert 19 situation has developed we've continued to hold advisory boards.

We've continued to have our one discussions we do these through virtual platforms of course, but we've had really great engagement.

Daniel C. Martin: We do these through virtual platforms, of course, but we've had really great engagement that has helped inform our thinking not only on positioning for prominence in the market but thoughts on strategies, tactics, that sort of thing. A lot of the research that we've looked at, as I mentioned in my prepared remarks, would suggest that oncology has had some level of resilience just in terms of treatment volume, but clearly, it's having an impact on patient visits. And it may, you know, ultimately, have some impact on launch therapies and launch drugs in terms of rate of uptake, and we'll just have to see. But beyond that, beyond what I shared in my prepared remarks, that's really what we're hearing. Yeah, thanks, Dan.

That has helped inform our thinking not only on.

Positioning for Britain into the market, but thoughts on.

Strategies tactics that sort of thing.

A lot of the research that we've looked at.

As I mentioned in my prepared remarks would suggest that oncology has had some level of Brazilians.

Just in terms of.

Treatment treatment volumes.

Clearly is having an impact on patient visits.

And it may ultimately.

Had some impact on launch therapy.

Lunch drones in terms of rate of uptake and we'll just have to see.

But.

Beyond that beyond what I shared and in the prepared remarks.

That's really what we're hearing.

Yes, thanks, Dan So Orlando for that answers that second question that you had with respect to intrigue direct we disclosed today that the end for entry is 426 subjects. So just wanted to be clear that. The addition of these subjects to entry has no impact on powering of this.

Steven L. Hoerter: So, Orlinda, hopefully that answers that second question that you had. With respect to intrigue, you're right, we disclosed today that the N for intrigue is 426 subjects. So, just wanted to be clear that the addition of these subjects to intrigue has no impact on the powering of the study.

This is just about getting to the requisite number of events for the study to have those study readout in a timely fashion and Matt maybe you want to offer some additional commentary with respect to.

Impact of Coven 19, and other considerations that may have been taken into account as we thought through this.

Thanks, Steve So, yes, and so you know as as we had the the early information about the.

A number of patients that were looking the early in the study who.

I might have come off the study in Didnt have central confirmation of progression.

Gave us a better estimate in terms of the overall sample size stress and certainly as Steve mentioned this very modest increase in sample size.

No no allow us to get to the required number events, which has not changed the statistical analysis plan.

This.

The implement implementation of the processes, we put into place again, we feel very comfortable during this particular unusual time to Cook, a 19 pandemic and with the team being close communication with investigators and the sites in April to implement a local procedures as well, we still feel very comfortable.

The able to collect information there will be necessary to them you evaluate the effective or putting that in second line setting.

Great. Thank you.

Thanks, I wanted to.

And this concludes todays kinase session I want to turn the call over to Steve harder for closing remarks.

Yes. Thank you very much Frederick and thanks, all of you for joining us on the call today.

Look forward to continue to update you on our progress as the rest of year progresses, and we wish each of you safety and good health. These challenging times have a great.

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

Yes.

[music].

Good afternoon, everyone and welcome to the Big.

Steven L. Hoerter: This is just about getting to the requisite number of events for the study to have the study read out in a timely fashion. Matt, maybe you want to offer some additional commentary with respect to the impact of COVID-19 and other considerations that may have been taken into account as we thought through this. Thanks, Steve.

The aside from from Medicals first quarter 2020 financial results Conference call.

Today's call is being recorded at this time I would like to turn the Carlo What's a Jan Robertson Vice President Investor Relations. Thank you Jane going it.

Matthew L. Sherman: So yes, as you know, as we had the early information about the number of patients that we're looking at early in the study of who, [inaudible] This, you know, the implementation of the processes we put into place, you know, again, we feel very comfortable during this particular unusual time of the COVID-19 pandemic. And, you know, with the team being in close communication with investigators and the sites and able to, you know, implement local procedures as well, we still feel very comfortable being able to collect the information that will be necessary to evaluate the effect of a print mint in the second line setting. Thanks, Rolanda. And this concludes today's Q&A session. I would like to turn the call over to Steve Hoerter for closing.

Steven L. Hoerter: Yeah, thank you very much, Frederica. And thanks to all of you for joining us on the call today. We look forward to continuing to update you on our progress as the rest of the year progresses. And we wish each of you safety and good health in these challenging times. Have a great night.

Thank you had read that welcome and thank you for joining us today, because it's got the favorites first quarter 2020 financial results I generally, but then vice President Investor Relations at the site.

Unknown Executive: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. [inaudible] , , , , , , , , , , , , , , , , , , , , ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ??.

Jennifer Larson: . Good afternoon, everyone, and welcome to the Decipher Pharmaceuticals first quarter 2020 financial results conference call. Today's call is being recorded. At this time, I would like to turn the call over to Jen Robertson, Vice President, Investor Relations. Thank you, Jen, go ahead. Thank you, Federica. Welcome, and thank you for joining us today to discuss Deciphera's first quarter 2020 financial results. I'm Jen Robinson, Vice President, 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, Matt Sherman, Chief Medical Officer, Van Martin, Chief Commercial Officer, and Tucker Kelly, Chief Financial Officer.

With me this afternoon.

Actual results and provide a general corporate update.

You've heard our president and Chief Executive Officer, not Sherman Chief Medical Officer, San Martin Chief Commercial Officer Soccer, Kelly Chief Financial Officer.

Before we begin I like to realize he was there any statements we make on this call but are not surgical site.

Jennifer Larson: 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 Provision 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, the impact of COVID-19, 2020 guidance, review and status of our NDA submission, and preparations for potential commercial bonds. 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 the impact of COVID-19, the execution of clinical trials, the timing of study data, the actions of regulatory agencies, and those set forth in our most recent quarterly report on Form 10-Q, as well as our other FCC filings. We assume no obligation to update or revise any forward-looking statements.

But the statement.

Bucking, the current beliefs and expectations of management.

The safe Harbor provision of the private Securities Litigation Reform Act like the 95.

Examples of forward looking statements made during this conference call include the status of Dark second highlight for our preclinical and clinical study.

Technical Goodnight.

When he died in my view is that it's about 88 submission and preparation for our for potential commercial launch.

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 but for the sake.

And we cannot assure you that our expectation will be achieved.

Such risks and uncertainties include the impact of cobot, making the execution of clinical trials. The tiny study data the actions of regulatory agencies and those set forth and our most recent quarterly report on form 10-Q, as well are there are other filings.

We assume no obligation to update or revise any forward looking statement.

Following this call it replay will be available on the company's website W.W. dot Besides <unk> dot com without I will now turn the call over the border President and Chief Executive Officer up this I see.

Steven L. Hoerter: Following this call, a replay will be available on the company's website, www.deciphera.com. With that, I will now turn the call over to Steve Hoerter, President and Chief Executive Officer of Decipher. Thank you, Jen. Good afternoon, everyone, and thank you for joining us on this call to discuss our first quarter 2020 financial results. In addition to providing our financial results and regular quarterly business update, today, we are also reaffirming the timing of our clinical and commercial milestones and providing an update on the potential for COVID-19 to affect the business. Given the uncertainties that the COVID-19 pandemic presents, I want to emphasize that the outlook presented today is based on the assumption and the hope that the most severe impacts will be of a short-term nature over the next few months rather than a prolonged and sustained disruption to everyday life.

Thank you John Good afternoon, everyone and thank you for joining us on this call to discuss our first quarter 2020 financial results.

In addition to providing our financial results and regular quarterly business update today. We are also reaffirming that funding of our clinical and commercial milestones.

And providing an update on the potential for covered 19 to affect the business.

Given the uncertainties the pickup in 19 pandemic presents I want to emphasize that the outlook presented today is based on the assumption I know that the most severe impacts are of a short term nature over the next few months, rather than a prolonged and sustained disruption to everyday life.

That's decipherable, our first concern is maintaining the safety and security as our employees as well as the patients and physicians participating in our ongoing clinical trials and this principle has guided the actions we've taken today.

Steven L. Hoerter: At Deciphera, our first concern is maintaining the safety and security of our employees, as well as the patients and physicians participating in our ongoing clinical trials. And this principle has guided the actions we've taken today. In early March, we adopted a work-from-home policy for our employees, with limited exceptions for certain business-critical activities, including ongoing laboratory research activities. For these activities, we have implemented appropriate safety measures designed to comply with federal, state, and local guidelines.

In early March we adopted a work from home policy for our employees with limited exceptions for certain business critical activities, including ongoing laboratory research activities.

For these activities, we have implemented appropriate safety measures designs to comply with federal state and local guidelines.

While adapting to our new work environment. That's presented its challenges I have been continually impressed by the team's ability to adjust well said fastly, maintaining our corporate values and executing on our company's mission.

As the covert 19 pandemic a spread around the world to decipher team has worked to ensure the safety and well being of patients enrolled in our clinical studies and their clinical teams.

We are focused on advancing our ongoing clinical studies that are actively monitoring risks associated with potential interruptions to our programs. We are in frequent communication with our clinical study sites and contract research organizations around the world.

As you may be aware some clinical trial sites are restricting site visits by sponsors NCR rose and imposing restrictions on the initiation of new trials, new patient enrollment and patient visits to protection, both site staff and patience from possible covert 19 exposure.

While our studies remain open for enrollment we have provided guidance that new patient enrollment may occur at sites, where resources allow these patients to be safely and wall and closely monitored.

Steven L. Hoerter: While our studies remain open for enrollment, we have provided guidance so that new patient enrollment may occur at sites where resources allow these patients to be safely enrolled and closely monitored. And some sites in our studies have temporarily paused enrollment of new patients. Importantly, patients already enrolled in all of our clinical studies continue to receive investigational drugs, and we are focused on supporting sites and providing ongoing care for these patients. We are also actively implementing remote and local procedures per recent FDA guidance and working with investigators to help ensure patients receive care in a safe manner consistent with agency guidelines. As of this time, while there has been a slowdown in patient enrollment in the current environment, we currently expect to achieve our previously stated clinical milestones in the second half of this year, including full enrollment and entry, our phase three study and second line JIT, and updated clinical data for DCC 3014 from the dose escalation portion of the study in tenosynovial giant cell tumor patients. Selection of a Phase 2 dose for DCC3014 and Opening the Expansion Portion of the Study in TGCT Patients and updated clinical data from both of the Phase 1b studies of Rabaster

Some sites and our studies have temporarily pause enrollment up new patients.

Importantly, patients already involved and all of our clinical studies continue to receive investigational drug and we're focused on supporting sites and providing ongoing care for these patients.

Updated clinical data for do you see Cdthirty 14 from the dose escalation portion of the study in tennis snowmobile giant cell tumor patients.

Selection of a phase two dose for DC, Cdthirty 14, and opening the expansion portion that the study in TGC chief patients.

And updated clinical data from both of the phase one be studies were bastards.

In addition, our discovery research for clinic preclinical efforts in early development activities are currently on track and we expect to file the I.M.D. for GCC 31, 16 are all kinase inhibitor in the second half from 2020.

Steven L. Hoerter: In addition, our discovery research for preclinical efforts and early development activities are currently on track, and we expect to file the IND for DCC 3116, our olk kinase inhibitor, in the second half of 2020. In terms of drug supply, Deciphera has commercial drug supply sufficient to support the potential launch of Repretinib and Fortlign JIT. Based on current inventories and supply plans, the company does not anticipate any COVID-19-related supply interruptions to its clinical programs at this time.

In terms of drug supply decipher has commercial drug supply sufficient to support the potential launch it reprinting and fourth line Jess.

Based on current inventories and supply plan. The company does not anticipate any covert 19 related supply interruptions to its clinical programs at this time.

With respect to our new drug application or N D. A former president of in patients with fourth line Jess we continue to work very collaboratively with the FDA as they review the submission which has a PDUFA target action date of August 13 this year.

Steven L. Hoerter: With respect to our new drug application, or NDA, for repretinib in patients with fourth-line GIST, we continue to work very collaboratively with the FDA as they review the submission, which has a PDUFA target action date of August 13th this year. We continue to build our commercial and medical affairs organizations to be ready to launch Repretnib in the U.S. upon potential approval. The RepredNev NDA is also part of Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among participating international health authorities. Under this program, we have received priority review for a new drug submission with Health Canada and a market authorization application with the Therapeutic Goods Administration in Australia for Repredative in advanced JIT.

We continue to build our commercial and medical affairs organizations to be ready to launch were present in the U.S. upon epicentral approval.

They were president of India is also part of project Orbitz and initiative of the FDA Oncology Center of excellence that provides a framework for concurrence submission and review of oncology drugs among participating international health authorities.

Under this program we have received priority review for a new drug submission with health, Canada, and a market authorization application with the therapeutic goods administration and Australia for credit in advanced chips.

In addition, we plan to submit a marketing authorization application to the European Medicines agency in the second half of this year.

Steven L. Hoerter: In addition, we plan to submit a marketing authorization application to the European Medicines Agency in the second half of this year. Given the evolving landscape, our commercial team has been preparing for a potential launch of RepretNib in a healthcare environment limited to no physical and personal promotional activity and therefore has been working intensively on an effective commercial launch using a virtual interaction model, if necessary. Lastly, we are in a strong position from a cash runaway perspective, which we expect to last us into the second half of 2020. Despite the challenges we face, we expect this to be an exciting year.

Given the evolving landscape our commercial team has been preparing for a potential launch it reported net and health care and.

Limited to know physics.

No activities.

For the working intensively on affects the commercial.

First of all the interaction model if necessary.

Like we are Oh position.

From my perspective, which we expect total assets and stuff like that half of 2020 <unk>.

Despite the challenges we say yes.

The tightening year.

In particular, we look forward to a successful and impactful first commercial launch of repressing. That's been fourth line Jets, if approved and to achieving full enrollment and entry.

And we remain confident about refreshments potential to alter the treatment landscape for patients in the post in that and et cetera.

Beyond regret that we believe that our earlier stage programs can each deliver significant value, creating a debts with additional clinical data for DC, Cdthirty 14, and Rapastinel and the filing of an eye NB for GCC 31, 16 later this year.

To review progress on our clinical programs ill now turn the call over some Nat Sherman, our Chief Medical Officer, Matt.

Thank you Steve.

Matthew L. Sherman: Thank you, Steve. First, I would like to review our progress with our pregnant mice, our investigational broad-spectrum kit, and PDGEL4-alpha kinase inhibitor. As Steve mentioned, the NDA for approval of a pregnant patient with fourth-line GIST is currently under priority review by the FDA with a PDUFA date of August 13th this year. The NDA's submission is supported by highly significant and, quite meaningfully, positive results from our Infectious Pivotal Phase III study of impregnated inpatients with 4th Line and 4th Line Plus. Today, we also announced that two posters containing additional data from the Infectious Study will be featured at the annual meeting, which is being held virtually this year from May 29 through May 31. The first poster will focus on quality-of-life outcomes with reprinted in the 4th line and 4th line plus treatment settings. While the second poster will focus on the safety profile for pregnant women, including the impact of adverse events on patient-reported outcomes.

First I'd like to review our progress with her pregnancy, our investigational broad spectrum kit MPV, Jennifer Alpha kinase inhibitor.

Steve mentioned.

Approval other pregnant patients before one just is currently under par the review by the yet.

With the PDUFA date of August 13th this year.

The FDA submission is supported her every significant yeah of course, we meaningfully positive results from our tick. This pivotal phase three study of recruitment in patients with fourth one important line clubs.

Today, we also announced the especially considering additional data from in pick this study will be.

Well meeting, which is being held virtually this year for May 29 through may 31st.

The first poster will focus on quality of life outcomes with we've written up in the fourth one in fourth one plus treatment settings, well. The second poster will focus on the safety profile for printed including the impact of adverse events on patient reported outcomes.

We look forward to reporting these data later this month.

Matthew L. Sherman: We look forward to reporting these data later this month, and as we work toward the potential approval and launch of the Apprentice and Patients for the Advanced, who have received prior treatment with imatinib, subunitinib, and regoraptinib. We continue to explore other possible uses of reprintinib, including in second line, just pain. Intrigue is our ongoing randomized phase 3 study of recruitment in patients with second-line GIFs compared to the current standard of care submitted to us. We have now finalized the amendment for Intrigue, and the sample size will be 426 patients. We have approximately 118 sites activated in 22 countries.

As we work towards the potential approval and launch of <unk> I've been patients with advanced chips, but received prior treatment with the magnet Sunitinib and record after that we continue to explore other post for uses are written up including in second line just patrons.

In tree is our ongoing randomized phase three study ever created in patients with second Mindjet.

Compared to the current standard of care soon.

We have now finalized the amendment to our intrigue and the sample size will be 426 patients.

We have approximately 118 sites activated in 22 countries.

The global diversity and number of sites have been beneficial and helping us continue to enroll patients as we target for enrollment.

Matthew L. Sherman: The global diversity and number of sites have been beneficial in helping us continue to enroll patients as we target full enrollment. Our clinical team has been in close communication with study sites to implement remote and local procedures per the recent FDA guidance to ensure the appropriate care of patients. In addition, we expect to present data from at least one of the extension cohorts of our ongoing Phase I study of Roperton in the second half of this year. Additionally, beyond ribritinib, we are focused on the development of DCC3014, our harmonic selective inhibitor of CSF1R, for patients with tenosynovial giant cell tumor, or TGCT.

In addition, we expect to present data from at least one of the expansion cohorts of our ongoing phase one study were pregnant and the second half of this year.

Beyond that Britain that we're focused on the development of DCC 30, 14, our collective inhibitor, let's see us of what our for patients with tennis, Inovio Giants cell tumor or TGC too.

We believe there any 14 has the potential to fulfill the unmet medical need for an effective treatment with a favorable safety profile for these patients.

Matthew L. Sherman: We believe 3014 has the potential to fulfill the unmet medical need for an effective treatment with a favorable safety profile for these patients. The only approved systemic therapy for patients with TGCT is texidartenib, a small molecule inhibitor of a number of different kinases, including CSF1R, which was approved in August of last year with a boxed warning for hepatitoxicity and is subject to a risk evaluation We are continuing to enroll PGCP patients in the ongoing dose escalation portion of the Phase I study. However, in the second quarter, due to the COVID-19 pandemic, and given that this is not a life-threatening disease, we are seeing a slower-than-expected enrollment rate. Despite this, we are still currently expecting to present data from additional patients in this study, select a phase 2 dose, and open the phase 2 expansion portion of the study in TGCT patients in the second half of this year.

The only approved systemic therapy for patients with TCT is teksid torture that a small molecule inhibitor well the number of different kinase was including sales with one or which was approved in August of last year with a boxed warning for a tablet toxicity and is subject to a risk evaluation the mitigation strategy or Rems program.

We're we're continuing to enroll TGC patients and the ongoing dose escalation portion of the phase one study.

In the second quarter due to the Coca 19 pandemic and given that this is not a life threatening disease, we're seeing a slower than expected enrollment trend.

Right. This we are still currently expecting to present data from additional patients in this study select the phase two dose and to open the phase two expansion portion of the study and TGC t. patients in the second half of this year.

Turning now to turning now to a best in it or potent and selective tied to inhibitor. We're conducting two clinical studies in combination with chemotherapy, one with Paclitaxel and one with carbo platinum.

Matthew L. Sherman: Turning now to ribasinib, our potent and selective type 2 inhibitor, we are conducting two clinical studies in combination with chemotherapy, one with paclitaxel and one with carboplatinib. Part one of each study was designed to select a combination dose of robasinib with each chemotherapeutic agent, and part two of each study was designed as a Simon two-stage design. In the first stage, the combinations are being evaluated in multiple solid tumor cohorts in up to 18 patients each.

Matthew L. Sherman: If there are more than 4 responses in a given cohort, then that cohort is expanded in the second stage to enroll up to a total of 33 patients. Last year, we presented preliminary data from Part 1 of the study of ribacinib in combination with paclitaxin, which showed encouraging preliminary activity with objective responses in patients who have previously received tacotaxel therapy across multiple solid tumor types.

Part one of each study was designed to select the combination dose of predestined that with each chemotherapeutics agent and part two of each study was designed as a signed in two stage design.

In the first stage the combinations are being evaluated in multiple solid tumor cohorts and up to 18 patients each.

If there are more than four responses have been given cohort than that cohort is expanded in the second stage to roll up to a total of 33 patients.

Last year, we presented preliminary data from part one of the study ever bastion of in combination with Paclitaxel.

These are encouraging preliminary activity with objective responses in patients who have previously received paclitaxel therapy across multiple solid tumor types.

This afternoon, we announced that impart to the Paclitaxel combination study we have observed the required number of responses and both the endometrial and ovarian cancer cohorts triggering the expansion enrollment in these cohorts. We also announced today that we will present initial data from the end of mutual cohort in part to the study at the ASCO.

Matthew L. Sherman: This afternoon, we announced that in Part 2 of the Paclitaxel Combination Study, we observed the required number of responses in both the endometrial and ovarian cancer cohorts, triggering the expansion of enrollment in these cohorts. We also announced today that we will present initial data from the Endometrial Cohort in Part 2 of the study at the ASCO meeting this year. In addition, we have added a new carcinosarcoma partner in part two of the study based on the encouraging antitumor activity from part one presented at the triple meeting last year that showed partial responses in both patients with carcinosarcoma who were enrolled in the trial. In our Phase 1B2 study with ribacinib in combination with carboplatinin, we're continuing to enroll patients with breast cancer, ovarian cancer, and mesothelioma in Part 2 of the study at the recommended Phase 2 dose of 50 milligrams BID, which was reduced from 100 milligrams BID based on the observed frequency of muscular weakness and preliminary data from the ongoing Part 2 portion of the study

This year.

In addition, we've added a new Carson of sarcoma cohort in part two of the study based on the encouraging anti tumor activity from part one presented at the Triple meeting last year, but showed partial responses in both patients with carcinoma sarcoma, who were enrolled in the trial.

And our phase one be two study with Redev slip in combination with Carboplatin, we're continuing to enroll patients the breast cancer ovarian cancer NBC affiliate in part to the study that's a recommended phase two dose of 15 milligrams VIP, which was reduced from 100 milligrams VIP based on the observe frequency.

Square weakness and preliminary data from the ongoing part two portion of the study.

We expect to present data from part one of this study in the second half of this year.

Finally, our discovery research engine continues to generate new product candidates for novel targets and we disclosed last year at the next target will be pursuing is the oak kind is initiating factor and your top of GE pathway.

Namely DCC 31, 16 is our potential for some classical kindness inhibitor, we intend to develop for the treatment immune ralph's cancers, and we continue to expect the file the item di for this program later this year.

The safer is a company founded on deep insights into kind of its biology and inspired by the prospect of developing important new medicines for the treatment of cancer.

Thus far this year, we have demonstrated our ability to remain focused on discovering and developing novel drug candidates based upon our proprietary research. Despite the significant challenges that the safer and the biotechnology community as a whole basis from the ongoing called the 19 pandemic.

Matthew L. Sherman: Thus far this year, we have demonstrated our ability to remain focused on discovering and developing novel drug candidates based on our proprietary research, despite the significant challenges that Deciphera and the biotechnology community as a whole face from the ongoing COVID-19 pandemic. I look forward to updating you on the progress with our clinical and preclinical programs throughout the year. I will now turn the call over to Dan Martin, our Chief Commercial Officer, to discuss our commercial preparations for a potential launch of our print in the U.S. Dan? Thank you, Matt.

I look forward to updating you on the progress with our clinical and preclinical programs throughout the year.

I will now turn the call over to Dan Martin, Our Chief commercial officer, and discuss our commercial preparations for a potential launch of are printing in the U.S.

Dan.

Thank you Matt.

Daniel C. Martin: Since its founding, Deciphera has been steadfast in its mission to discover and develop innovative therapies to improve the lives of patients with cancer worldwide. Now, as we prepare for the potential commercial launch of prednib, the entire organization is laser-focused on ensuring we optimize our ability to bring this important therapy to patients in need, despite the challenges that the coronavirus pandemic may pose. Although this is uncharted territory and things continue to evolve, I want to provide updates on several topics, including what we are hearing from market research regarding the impact of COVID-19 on providers and patients, how we are adapting our launch planning, and our current thinking on how the potential launch of Prednis could be impacted. Results from various industry surveys suggest that patient visits across many specialties, including oncology, have decreased compared to pre-pandemic levels.

Its founding just site has been steadfast and its mission to discover and develop innovative therapies to improve the lives patients with cancer worldwide now as we prepare for the potential commercial launch for Fred you.

Hi organization laser focused on ensuring we optimize our ability to bring this important therapy to patients in need despite the challenges the current buyers pandemic may pose.

Although this is uncharted territory and they continue to evolve I want to provide updates on several topics, including what we're hearing from market research regarding the impact of covert 19 on providers and patients. How we are adapting our launch planning and our current thinking on how the potential launch of a present it could be impacted.

Results from various industry survey suggests that patient visits across many specialties, including oncology have decreased compared to pre pandemic levels. Despite this initial data suggests and oncology the impact of both new patient starts and overall patient treatment volume may be less than another specialties.

Remains to be seen if the resilience. We are seeing oncology contains as the data mature smartfolio reflect the impact of abandoned.

Not surprisingly in person any person interaction between oncologists in sales representatives have declined dramatically.

Daniel C. Martin: However, oncologists appear to be increasingly open to virtual engagement through various technology-enabled platforms to meet the unique challenges posed by the pandemic. The Cross-Functional Launch Team has done an outstanding job adapting our launch preparations and go-to-market strategies to ensure we optimize our ability to bring the product to patients in need pending FDA approval. We've hired a very talented commercial team, including approximately 40 sales representatives with extensive oral oncology. Given our working home policy, we've converted our entire training program, including our launch meeting, to a virtual platform. We have modified key go-to-market strategies and core elements of our planned tactical mix, including developing comprehensive remote detailing. Increasing our investment in digital and other non-personal marketing channels. The team has devised and implemented our launch plans without losing focus on the importance of providing disease education to providers and patients prior to approval. In addition to our previously launched provider-oriented website, RethinkGIST.com, we recently launched our patient site, JustTogether.com, which provides important education and resources to support patients and caregivers during their treatment journey.

However, oncologists appear to be increasingly opened to virtual engagement through various technology enabled platforms.

Anything unique challenges posed by the pandemic cross functional launch team has done an outstanding job adapting our launch preparations and go to market strategies to ensure we optimize our ability to bring patient need and the FDA approval.

We have hired very telling commercial team, including approximately 40 sales representatives with extensive oral oncology launch experience.

Given our work from home policy, we've confirmed our entire training program, including our launch to virtual platforms.

We've modified key go to market strategies in core elements of our plan tactical mix.

To close developing comprehensive remote detailing capabilities and increasing our investment digital and other nonpersonal marketing channels.

It seems devised an implemented these changes to our launch plans without losing focus on the importance of providing disease education to providers and patients prior to approval.

In addition to our previously launched provider oriented web site rethink just dotcom, we recently launched our patient site.

Yes, together dotcom, which provides important education and resources to support patients and caregivers during their treatment Jeremy.

We look forward to providing more updates on our launch preparations and core initiatives to support providers patients and caregivers and their fight against chest.

Daniel C. Martin: We look forward to providing more updates on our launch preparations and core initiatives to support providers, patients, and caregivers in their fight against COVID-19. Our discussions with JISC-KOLs confirm that despite the challenges, things that have not included The High Unmet Need and Fork Lining, their excitement for Reprentant, and their dedication to providing optimal care for their patients.

Our discussion with GSK wells confirmed that despite the challenges of code 90 things that have not changed include the high unmet need in Portland Jets their excitement for Britain and their dedication providing optimal care for their patients as a result, our view of presence practice changing.

Daniel C. Martin: As a result, our view of the president's practice-changing potential for the treatment of GIST has not changed, nor has our expectation for the president's mid and long-term commercial potential. That said, while we are confident in our revised launch plans, we also recognize that in the short term, challenges from COVID-19 may slow the rate of uptake. Additionally, it's likely that the increased unemployment rate caused by the pandemic will increase the number of uninsured or underinsured patients, which in turn could drive increased utilization of our patient assistance program. As an organization, we are tremendously excited to potentially launch Deciphera's first drug this year and are extremely focused on bringing this important treatment option to patients in need. I look forward to updating you on our progress. I will now turn the call over to Tucker Kelly, our Chief Financial Officer, to review the financial results. Thanks Dan.

Potential for the treatment of just has not changed nor has our expectation for credit Nems mid and long term commercial potential.

That said, while we are confident in our revised launch plans. We also recognize that in the short term challenges from cobot 19 may slow the rate of uptake.

Additionally, it's likely that the increased unemployment rate caused by the end.

Will increase the number of uninsured or underinsured patients, which in turn could drive increased utilization of our patient assistance program.

As an organization, where tremendously excited to potentially launched a cypress first drug this year and are extremely focused on bringing this important treatment option to patients need.

Look forward to updating you on our progress in coming months.

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

Thanks, Dan Let me take just a minute to discuss a few highlights our first quarter financial results.

Thomas Patrick Kelly: Let me take just a minute to discuss a few highlights from our first quarter financial results. Importantly, in the current market environment, we remain well capitalized to fund our business as we prepare to potentially launch Pregnant this year. We ended the first quarter with cash, cash equivalents, and marketable securities of approximately $691.5 million.

Importantly, the current market environment, we remain well capitalized to fund our business as we prepare to potentially launch for credit this year.

We ended the first quarter with cash cash equivalents in marketable securities of approximately 691.5 million.

Based on our current plans, we expect that our cash would be sufficient to fund our operations and capex into the second half of 2022.

Thomas Patrick Kelly: Based on our current plans, we expect that our cash will be sufficient to fund our operations and CapEx into the second half of 2022. In the first quarter of 2020, our total operating expenses increased to approximately $75.3 million from $49 million in the first quarter of last year, based on increased investments to support our potential commercial launch of Ipretinib, as well as increased clinical development activities across the pipeline. Research and Development expenses were approximately $51.4 million, and selling general and administration expenses were approximately $23.9 million for the first quarter of 2020.

In the first quarter 2020, our total operating expenses increased.

Thomas Patrick Kelly: We expect our expenses to continue to grow modestly over the coming quarters as we continue to invest in our commercial and clinical activities. And with that, I'll now turn the call back over to Tucker. Thank you, Tucker. I'd like to take a moment to thank the entire team here at Deciphera for their continued dedication to our mission in the face of adversity as we adapt to these rapidly changing conditions presented by COVID-19.

To approximately 75.3 million from 49 million in the first quarter of last year based on increased investments to support a potential commercial launch of accretive as well as increased clinical development activities across the pipeline.

Research and development expenses were approximately 51.49 and selling general and administration expenses were approximately 23.9 million for the first quarter of 2020.

We expect those expenses to continue to grow modestly over the coming quarters as we continue to invest in our commercial and clinical activities. So with that I'll now turn the call back over to Steve.

Thank you Dr. I'd like to take a moment to thank the entire team here to safer for their continued dedication to our mission in the face of adversity as we adapt to these rapidly changing conditions presented by covert 19.

Because of our focus and determination 2020, it will be a transformational year for the company as we await the potential approval and launch of accretive in the U.S. Later this year, we look forward to keeping you all updated as we continue to progress throughout the year and with that Federica I'd like to open the call for questions.

Steven L. Hoerter: Because of our focus and determination, 2020 will be a transformational year for the company as we await the potential approval and launch of pretinib in the U.S. later this year. We look forward to keeping you all updated as we continue to progress throughout the year. And with that, Frederica, I'd like to open the call for questions. Sure, and your first question comes from the line of Jessica Fye with JPMorgan. Hi, this is Yuka on the call for Jessica.

Sure and your first question comes from the line of Jessica Fye with JP Morgan.

Hi, This is you're going to call for Jessica. Thank you for taking our question.

We expect a pre approval inspection will still be required prior to want to ft decision I regret that has taken place yet.

Yes, Hi, you go it's Steve Thanks, very much for the question. So we haven't provided a need any additional color in terms of the granularity that you've mentioned that you're down to the level of a PPA size and the like what I can say is that we continue our very collaborative dialogue with with the agency. We're very pleased with the progress and we look forward to the agency take.

Taking action on the application by the PDUFA date, which as you know is obvious 13.

Great and and.

Steven L. Hoerter: And as for my second question, I have, have patients enrolled and intrigued been able to get their scans within the defined windows and the study protocol despite the pandemic? Yeah, thanks for the question. We've been working very closely, as Matt mentioned in his prepared remarks with clinical trial sites across all of the trials, including Intrigue. Matt, would you like to provide a little bit more color about the nature of the work that we've been doing with respect to Intrigue specifically? Sure. No, thanks, Steven.

My second question I have how patients enrolled industry been able to get their scans within that define windows in the study protocol. Despite the pandemic.

Yes. Thanks for the question we've been working very closely as Matt mentioned in his prepared remarks with clinical trial sites across all of the trials, including entry that would you like to provide a little bit more color about the nature of the work that we've been doing with respect to treat specifically.

Sure no. Thanks, Steven Thanks for the question. So as we indicated you know due to the pandemic.

Matthew L. Sherman: Thanks for the question. So, you know, as we indicated, due to the pandemic, the FDA has issued guidance for pharmaceutical sponsoring companies to be able to monitor patients, you know, both centrally as traditionally done as well as locally. So we're able to implement those procedures at sites and, you know, feel very confident with the data that's being collected through the pandemic.

The FDA has issued guidance about from so sponsoring companies to be able to monitor patients.

Both centrally has traditionally gone as well as locally so we're able to implement those procedures at sites and feel very confident with the data that's been quite good.

Through the through the pandemic started through the pandemic.

Thank you.

Unknown Executive: And your next question comes from the line of Chris Raymond with Piper Sound. Hey, thanks. Just two questions. I guess, first, it's more of a general sort of commercial question. I know you guys have talked about launch prep, and I would imagine you're not interested in giving us too much detail, but, you know, the Voyager miss, you know, I think was a pretty big deal.

Your next question comes from the line of Chris Reimer, what type of Sandler.

Thanks.

Just two questions.

I guess first.

It's more of a general sort of commercial question you guys talked about launch prep.

And.

Imagine you're not interested in getting us too much detail, but you know.

The Voyager.

Miss I know I think was a pretty big deal.

Steven L. Hoerter: In that you now have this market essentially to yourself in terms of, um, kit inhibitors. So, I guess... Can you give any more color about how this changes your commercial picture? Obviously, having one less competitor is good, but can you talk a little bit about how you are sort of structuring the field force differently, if at all, in sort of the go-to-market approach? I mean, obviously, you know, you've got to get a kid out there for a small subset, but just, you know, in terms of the broader population.

And that you now have this market essentially to yourself in terms of.

Kit inhibitors, so I guess.

Can you give any more color about how this changes your.

Your commercial picture, obviously, having one less competitors is good.

But can you talk a little bit about how you are issued restructuring the the field force differently if at all and.

And sort of the go to market.

Roche.

Obviously.

You got to get out there for a small subset, but just in terms of the broader population.

And then.

Steven L. Hoerter: And then, you know, maybe secondly, just in terms of the entry study, can you just remind us what the bar for success in that study is? I think you've talked about two to three months increase over Sutin. Can you just reaffirm that and just sort of talk about what we should be looking for? Thanks. Hey Chris, it's Steve.

Maybe secondly.

Just in terms of the entry.

Entry study.

You just remind us what's the bar for success.

And that study I think you've talked about two to three month increase overseas.

Can you sort of just reaffirm that im just trying to talk about what we should we look for thanks.

Hey, Chris It seems so let me take the second part of your question first and then I'll start off addressing your other question about Voyager and then turn it over Syddanmark offer some additional color on from a commercial point of view. So so first with respect to entry you're right in terms of the study versus.

Steven L. Hoerter: So let me take the second part of your question first and then I'll start off addressing your other question about Voyager and then turn it over to Dan Martin to offer some additional color from a commercial point of view. So, first, with respect to Intrigue, you're right. In terms of the study versus Sutent, we would expect Sutent to offer about six months of PFS. And that's consistent, I think, whether you look at the drug label or whether you look at other published studies with Sunitinib or Sutent. And so we would expect that a two to three month improvement in progression-free survival over Sunitinib would be a favorable study. And we haven't provided any additional detail in terms of powering assumptions and the like.

And we would expect just do tend to to offer about six months of PFS and Thats consistent I think whether you look at the drugs label or whether you look at.

That other published studies with Sunit never suits and so we would expect that two to three month improvement of progression free survival over Sumit net would be would be a favorable study and we haven't provided any additional detail in terms of powering assumptions in the light.

Steven L. Hoerter: With respect to your first question about Voyager, I mean, I think first and foremost it's certainly disappointing news for the GIST community. To have a negative study in this disease, as you know, this is a group of patients and a community that's really been waiting for new options for patients. And I think the data that we saw from Voyager certainly puts in context the potential for repretinib in the INVICTUS study that we presented last year, where, as you know, we showed for the primary endpoint an 85% reduction in the risk of progression or death. So, you know, I think it does show that repretinib has the real potential to be best in class in this disease. So now I'll turn it over to Dan.

With respect to your your first question around Voyager I mean, I think first it's certainly disappointing news I think for the just community.

To have a negative study in this disease as you know this is a group of patients.

And a community that's really been waiting or new options for patients and I think the data that we saw from boys, you're certainly puts in context, the potential for repressed nib and the Invictus study that we presented last year, whereas you know we chose to the primary endpoint and 85% reduction in the risk of.

Progression or that so.

I think it does does showed that the refresh and it has the real potential to be best in class in this disease. So now I'll turn it over to Dan Martin Dan you want to offer any additional comments in terms of commercial contracts.

Steven L. Hoerter: Martin, do you want to offer any additional comments in terms of commercial context? Sure. I think you framed it really well, Steve. I was just going to say that I really think that the Voyager outcome serves to really validate our long-held view of the core value proposition, the core clinical value proposition for president in GIST. GIST is a very heterogeneous disease from a mutational perspective.

Sure.

Thank you framed it really well Steve I was just going to say that I really think that.

The boys your outgrown serves to really validate our long held view of really the core value proposition core clinical value proposition for for President in just a just is a very had urgent genetic disease mutational perspective and you.

Daniel C. Martin: And, you know, I think this really underscores the need for a broad-spectrum inhibitor like Rupretinib. That's really been the strategy all along and why this drug was designed specifically for GIST. So we've always viewed Rupretinib as really the drug with real practice-changing potential, certainly in the fourth line and hopefully down the road beyond that. So in terms of your question about whether it is leading us to change our Field Forest Ties or Structure, that sort of thing, the Voyager result is not, we don't view that as a rationale to change our strategy. So, full steam ahead.

I think there's really underscores the need for a broad spectrum inhibitor.

Mike were present, it really had been.

The strategy all along.

And why this drug was designed specifically for just.

So we've always knew retinal thats really.

The drug with real practice changing potential.

Certainly in the fourth line and hopefully down the road beyond that.

So in terms of your question about is it leading us to change our.

Salesforce size or structure that sort of thing.

Mortgage or result, if not we don't do that.

Rationale due to change our strategy.

So.

Full steam ahead.

Okay, one more follow up if I can so.

Daniel C. Martin: Okay, one more follow-up question if I can. So, it's another general question, but if you look at analogs of FDA's Approval Cycle for Other RKOR Designated Oncology Compounds, you would assume that, um... Your August PDUFA date might be, you know, outside the norm of what they generally approve. If it comes earlier, including, you know, much earlier, are you ready regardless? Uh, to launch. Yeah, Chris. It's Steve.

Some other general question, but.

Look at analogs of Fts.

Approval cycle for other or T O R.

Designated oncology compound.

One would assume that that.

Your your August PDUFA date might be.

Outside.

The norm of what they would they generally approved.

If it comes earlier.

Including you know much earlier are you ready regardless.

To launch.

Yeah, Chris It seems so that's a good question and you're right. When you look at the analog whether if you looked at drugs that have received breakthrough therapy designation as regret that has or you look at the handful of drugs that have been reviewed under our tour you're right. I think generally speaking those reviews tend to conclude earlier than to produce a date and so our team internally.

Steven L. Hoerter: So it's a good question. And you're right, when you look at the analogs, whether if you look at drugs that have received breakthrough therapy designation, as RepretNet has, or you look at the handful of drugs that have been reviewed under RTOR, you're right, I think, generally speaking, those reviews tend to conclude earlier than the PDUFA date. And so our team internally has been working really hard to be ready for what we would view as a reasonably accelerated timeframe, recognizing, of course, that it's up to the FDA in terms of the timeline and how they choose to act on the application up to the point of the PDUFA date. But we're really comfortable with our level of preparedness, as I mentioned in the prepared remarks, from a commercial supply perspective, we feel like we're And Dan and his team and Matt on the medical affairs side, I think they've done a really nice job building superb teams but also doing all the heavy lifting to be ready for a potential early approval should that happen. Great, thanks a lot. And your next question comes from the line of Eun Yang with Jeffery.

Has been working really hard to be ready for what we would view as a reasonably accelerated timeframe recognizing of course, it's up to the FDA in terms of the timeline in which they choose to act on the application to the point of the PDUFA date, we're really comfortable with our level of preparedness as I mentioned in his prepared remarks from.

Commercial supply perspective, we feel like we're in good shape, there and Dan and his team and that on the medical Affairs side, I think I've done a really nice job a building super teams, but also doing all the heavy lifting to be ready for a potential early approval should that come.

Great. Thanks, a lot.

Thank you next question comes from a line of Yang with Jefferies.

Thank you Steve as you pointed to how does that make high impact is on 10 any kind of slowly.

Steven L. Hoerter: Thank you. So Steve, as you pointed out, the pandemic impact is uncertain and it's fluid. Yet, you are maintaining your clinical timelines, including phase III intrigue studies. So my question to you is, is there something that you are seeing giving you such confidence, or is it purely based on your expectation of a short-term impact such that you can catch up later? Yeah, Eun.

You are maintaining your client timeline to including Sanjay you treat a steady.

So.

Question on Tuesday, you said is that something that youre seeing keeping is such a confidence or.

Is it purely based on your expectation all the short come.

Impacts that today, you can catch up nature.

Yes, yes, it's Steve Thanks for the question. It's a good question we've been getting a question similar to this as you can imagine from investors over the course of the last month or two.

Steven L. Hoerter: Thanks for the question. It's a good one. And we've been getting questions similar to this, as you can imagine, from investors over the course of the last month or two. So, as you point out, the impact of the pandemic is, you know, inherently uncertain. So, you know, we're not, you know, we don't have any additional insight, you know, aside from what we shared in the prepared remarks, which is that our guidance is predicated on this having a shorter-term impact, as opposed to a longer-term, fully disruptive impact. But based on the number of clinical trial sites that we have open, based on the number of countries now in which we're operating with intrigue, And so to the extent, you know, we need to change that guidance, we will, of course, do so, and we'll update investors at that time.

So as you point out the impact of the pandemic as you know inherently uncertain. So we're not.

We don't have any additional insight aside from what we shared in the prepared remarks, which as we believe in our guidance is predicated on this having a shorter term impact as opposed to a longer term fully disruptive impact, but based on the number of clinical trial sites that we have opened based on the number of countries now and which were operating.

Within tree and based on what we see in terms of enrollments in the study that all gave us comfort in the reiterating our guidance to have intrigue and rolls by the end of the year.

Steven L. Hoerter: But based on what's in view at the moment, we're comfortable with the reiteration of our guidance as to intrigue enrollment. Okay, and then in terms of the 19% increase in the total number of patients to be enrolled in Intrigue of Age Three, has that been signed off by the FDA? Thank you for the question. So we're comfortable now announcing what that N is, as we did, as Matt did in his prepared remarks, an N of 426 in Intrigue.

So to the extent, we need to change that guidance, we of course will and we'll update investors at that time, but based on what some view at the moment, we're comfortable with the reiteration of our guidance as to the entry enrollment.

Okay, and then in terms of a 19% increase into the number of patients to be in London Trico pages to me has that been signed off by the FDA.

Yes, so we've heard Doug. Thanks, you answer the question. So we're comfortable now announcing what that and as as we did as Matt did in his prepared remarks, and 426 and intrigue so were formally.

We have initiated the amendment process for the study and getting that information pushed out to clinical trial sites.

Yes, so with that is the new and for the intrigue studying we're looking forward as I noted to getting the study fully enrolled by year end and then reporting that out.

When when the time is right.

Thanks, and then my last question is on all Canadian maybe so I and the filing is on track for second half of the VCR. So obviously, it's have you already but.

Steven L. Hoerter: So obviously, it's very early, but given the target, is it reasonable to assume that the cancer types that you may go after are like pancreatic, lung, and colorectal cancers with a high frequency of RAS mutations? Yeah, you know, I think that's right. So, yes, you know, you noted the tumor types that have a high frequency of mutant RAS. And so those would be obvious tumor types for us to consider pursuing. We haven't yet disclosed which tumor types we will pursue.

Given the target.

It's reasonable to assume that.

The cancer testing you may go after our lack of pancreatic lung and colorectal cancer with a high frequency of of optimization.

Yes, I think thats right. So yes, you noted the tumor types that have a high frequency of niton RASM. So those would be obvious tumor types for us to consider pursuing we haven't yet disclosed what tumor types. We will will pursue we'll get to that later as we get the drug into the clinic and and are able to articulate.

Steven L. Hoerter: We'll get to that, you know, later as we get the drug into the clinic and are able to articulate further what the development path may be and specifically what tumor types we might select. But certainly, we would consider moving into tumor types where there's a high frequency of mutant RAS. Thank you very much, on the line for Peter Lawson. Hey guys, this is Waleed Al on behalf of Peter.

Further what the development path, maybe and specifically what tumor types, we might select but certainly we of course would consider moving into tumor types, where there was a high frequency in the address.

Thank you very much.

Thanks you.

Your next question comes from the line of Peter Lawson with Barclays.

Hey, guys. This is what lead on for Peter Thanks for taking my questions.

Unknown Executive: Thanks for taking our questions. Just had a question, sort of a follow-up as to an earlier question on your market strategy in advance. I just wanted to ask, you know, whether your thoughts have changed on pricing now, especially after the Voyager failure.

Just had a question sort of a follow up does too to an earlier question on your market strategy and events just.

And just.

I wanted to ask whether your thoughts have changed on pricing now, especially after the Voyager failure.

And how you're thinking about that.

Going forward.

Yes. Thanks for the question. So I'll start off and then I'll turn it over to Dan to offer some additional color I guess, what I'd say is that this it's premature for us to talk about potential price for recruiting. So we would do that to form a potential approval of the drug and we'd be in a position to talk about it I will offer that we.

Steven L. Hoerter: You know, and how you're thinking about that going forward? Yeah, thanks for the question. So I'll start off, and then I'll turn it over to Dan to offer some additional color.

Daniel C. Martin: I guess what I'd say is that, you know, it's premature for us to talk about the potential price for repretinib. So we would do that upon the potential approval of the drug, and we'd be in a position to talk about it then. You know, I will offer that we've done a considerable amount of market research with payers to get their reaction and to understand their perspective on the profile of repretinib based on the Invictus data. Dan, perhaps you'd want to offer some additional color in terms of what we hear from both physicians and payers. Sure. Thanks, Steve. So, good question. The research that we've done with a number of stakeholders, obviously payers being central to that, has really, very clearly shown us that payers appreciate not only unmet need and gist but the potentially best-in-class profile for RepredNib.

Done a considerable amount of market research with payers to get their reaction to understand their perspective on the profile of were threatened that based on the invictus data and Dan perhaps you'd want to offer some additional color in terms of what we hear from both physicians, but also compares.

Sure. Thanks, Steve.

Good question, we the research that we've done.

With the number stakeholders, obviously payers being central to that.

It's really very clearly shown us the payers appreciate not.

Not only unmet need and just but the potentially best in class profile for.

Daniel C. Martin: And so, the methodology you use in those studies, as you know, we review the approved therapies in the class and their prices and their profiles, as well as our profile. And what continues to come back is just that payers really appreciate how this drug may be able to help patients. So, as you said, it's premature for us to comment on pricing, and we'll be doing so, you know, in due time upon approval. Thank you so much.

Right now and so we.

Methodology used in those studies as you may know certainly.

We review the approved therapies in the class II and their prices and their profiles as well as our profile in what continues to come back is just that Theres really appreciate how this drug may be able to help patients. So as you said, it's premature for us to comment on pricing.

And we'll be doing so.

And do in due time on approval.

Got it thanks, so much lesser Alcoans just a question on your program Indeed TGT.

Unknown Executive: That's really helpful. And just a question about your program in the PGCT. You know, maybe if you could provide us some color on your differentiation between your drug and texadartenib. And, you know, as we look to the data in the second half, what would be the bar there, and what would you consider to be a win? Yeah, thanks for the question on 3014. So maybe I'll start off, and then Matt can add some additional color if you'd like to.

Yes, maybe if you can provide us some color on the.

Your differentiation between your drug and Texas Darden event as we look to the data in second half what would be the bar there and what you would consider to be a win.

Yes. Thanks for the question on 30 14, so so maybe I'll start off and then Matt can add some additional color if you'd like to so.

Steven L. Hoerter: So, you know, when we look at 3014 relative to the other approved agent to treat this disease, you know, I think that the things that come to mind for us in terms of distinctions between the two programs are that 3014 is highly selective for the target. So this is a very potent and selective CSF1R inhibitor, and pexidartanib, as Matt referenced in his prepared remarks, is a multi-kinase inhibitor that hits a variety of targets, including CKIT, and FLT3. And this is also a drug that, upon review, as you know or may recall, it was referred to an ODAC for a discussion about risk and benefit. And the drug was ultimately approved, but with a REMS and a black box warning for hepatotoxicity. And it's a dose of the drug that is a relatively high drug load in the range of 800 milligrams daily for patients.

When we look at that 30 14 relative to the the other improved agent to treat this disease I think the things that come to mind for us in terms of distinctions between the two programs.

Our the 30 14 is highly selective for the target. So this is a very potent and selective see us up when our inhibitor and Texas you know as Matt referenced in his prepared remarks is a multi kinase inhibitor that hits a variety of targets, including Sicad, including flipped three and this is also a drug that.

Fund to review as you know may recall that was referred to and ODAC for a discussion about risk benefit in the drug was ultimately approved but with a rems and a black box warning for hepatic toxicity and it's a dose of the drug that has a relatively high truck load in the range of 800 milligrams daily for patients. So we believe that there's a there's room.

In this disease setting for a more potent and selective agent.

Steven L. Hoerter: So we believe that there is room in this disease setting for a more potent and selective agent that has an attractive efficacy as well as safety profile for these patients. And we're looking forward to continuing to generate additional data with 3014 in patients with TGCT. Matt, do you want to comment a little bit on that or on additional data that may be coming in the second half of this year? Yeah, no, so again, clearly, the distinction between the safety profiles is, you know, maybe a very important aspect of treating this disease because, as we recognize, this is, you know, it's a locally aggressive disease, but it's not a malignant disease, so not generally life-threatening. Certainly, they can be associated with very severe morbidity, pain, swelling, and limitations of activities.

It has a an attractive efficacy as well as safety profile for these patients and we're looking forward to continuing to generate additional data with 30 14 inpatients with TGC, Matt do you want to comment a little bit on on that or on additional data that may be coming in the second half of this year.

Yes, no. So yes, so again clearly those distinction between 60 profiles you know maybe a very important aspects of treating this disease because as we recognized this is.

So locally aggressive disease, but that's not a malignant disease, so not generally the life threatening.

Certainly can be associate with very severe morbidity.

I mean swelling limitations of activities. So tolerable drug is really probably when the most important characteristics along with an efficacious drug and the pet and garden Rems Morgan certainly.

Matthew L. Sherman: So, a tolerable drug is really probably one of the most important characteristics, along with an efficacious drug, and the pexidartan and remsformin, you know, certainly restrict their use under the FDA program. So, just referring back to the data that we did present for the first three patients, we were able to show that not only did we have, you know, a good safety profile in the data that we presented at the CTOS meeting last year, but the first three patients that we enrolled all had initial reductions in their tumor volumes, and the first patient who was on the longest had a 48% reduction. After two cycles, and then after nine cycles of therapy, they had an 84% reduction in their tumor size. So again, you know, important early data that we believe can differentiate us from pexidartanib. And as we also said in our prepared remarks today, we continue to plan to have data to be able to update folks by the end of this year from the ongoing phase one, two study. I got it.

Restricts its use.

On to the FDA program.

So just referring back to the data that we did present for the first three patients.

We're able to show that not only because we have no. Good safety profile in the data we present the could see talks meeting last year, but the first three patients that we enrolled we all have reductions.

General and reductions in their tumor volume and the first patient goes on the longest had before the 8% reduction.

After two cycles and then after nine cycles of therapy had an 84% reduction in their tumor size. So again.

And our early data.

But we believe can differentiate us from fixing Gartner and as we also said in her prepared remarks. Today. We're continue we plan to have data to be able to update folks but ended this year from the ongoing phase one two study.

Thank you do you have any clarity on the potential regulatory path forward for 30 14.

Unknown Executive: Thank you. Do you have any clarity on the potential regulatory path forward for 3014? Yeah, no, I think it's, you know, for us specifically, it's probably too early to, you know, talk about a regulatory path forward for 3014, but clearly, you know, the development of PEXI-DARTnet did establish, you know, at least the FDA's perspective on what they were looking for in terms of response rate. Importantly, also, you know, functional outcomes or PROs were also a big part of the ODAC discussion for the approval of PEXI-DARTnet. It is certainly something that we should be, you know, considering for our development program. I got it.

Yes, I think its first specifically, it's probably too early to I'm.

I talked about regulatory regulatory path forward.

Further the 14, but clearly the development of pick starting to establish.

Third we have to his perspective on what what they were looking for in terms response rate.

Importantly, also functional outcomes are piros first wall, so a big part of the ODAC discussion.

For the approval, we'll pick sungard and that's the certainly something that we should be that will be considering for development program.

Got it. Thank you so much for taking the questions.

Unknown Executive: Thank you so much for taking the questions. Your next question comes from the line of Michael Schmidt. Hey guys, this is Charles Duan for Michael Schmidt.

Your next question comes from the line of Michael Smith.

Oh.

Hey, guys. This is Charles new on for Michael Schmidt, Thanks for taking the questions and congrats on all this progress.

Steven L. Hoerter: Thanks for taking the questions and congrats on all this progress. One quick one, swinging back to Repretnib, what are your high-level plans, or how has your thinking for commercializing Repretnib evolved with respect to the ex-US, as well as outside of greater China? And if you decide to go and partner up on this drug, how should we think of the economics for Deciphera, given that the Zylab collaboration was signed before Invictus, and now you obviously have much more data? Hi Charles, it's Steve.

One quick one of switching back to refresh what are your high level plants or how has your thinking for commercializing threatened nimble ball with respect to ex us as well as outside of greater China, and if you decide to go and partner out this drug how should we think of economics for decipher.

Given that as I lied collaboration was signed before Invictus and now you obviously have much more day data.

On the package for Kraton and getting that review process started we haven't provided any greater detail in terms of what our past might be to commercialization in Europe, what our go to market strategy might be in Europe, but I have said as there are two different options that we are evaluating one is the potential for us to go it alone in Europe and Sybil.

All the capital efficient structure to commercialize the threatened about our own any alternative to that of course would be to pursue epicentral licensing transaction.

Got it okay and shifting over to the asking the.

Steven L. Hoerter: Got it. Okay. And shifting over to ribastinib, as you evaluate type 2 inhibition in conjunction with either paclitaxel or carboplatin, is there any reason to believe that the drug may perform differently between these two combinations, either from a drug mechanistic perspective or from a disease biology perspective, given they may go into different tumor types? Yeah, it's a good question, Charles. I'll ask Matt to take that question. Matt?

Really tied to in addition in conjunction with other paclitaxel or cargo flattened is there any reason.

To believe that is wrote me performed definitely between these two combination either from a drug mechanistic perspective, or a disease biology perspective, given there they may go into different tumor types.

Yes, it's a good question Charles I'll ask Matt to take that question Matt.

Yes. Thanks. Thanks for the question. So yes, there's been a fair amount of preclinical data that's been done to look at the combination and actually theres been different combination partners second studies with.

Matthew L. Sherman: And thanks, you know, thanks for the question. So yeah, there's been a fair amount of preclinical data that's been done to look at the combination. And actually, there's been different combination partners that have been studied, you know, with the ribacinib, the type two kinase inhibitor. And what we've shown that with different combinations, we are able to have this, you know, Inhibitory Effect. I think the distinction may come from the tumor indications that will be developed because of paclitaxelin, Perhaps differently for different patients, so the selection of a particular I got it.

Rebel accident, the time to kindness inhibitor.

And what we've shown that with different combinations, we are able to have this yeah.

Inhibitory effect I think the distinction may come from the.

Tumor indications that well developed because pecos excellent hopeful and the use.

Perhaps differently for different patients so selection that particular tumor, but this question that particular combination would be applicable to which tumor will be will be targeted.

Got it thanks for taking the questions.

Unknown Executive: Thanks for taking the question. You bet. Thanks, Charles. And your next question comes from the line of Robin Cronkite: Hi, guys. Thanks for taking my question. There are two of them.

Hey, guys. Thanks Charles.

Your next question comes from the line of Robyn Karnauskas with Suntrust.

Hi, guys. Thanks for taking my question two of them one I'm sure you've heard a lot, but I think we just we need to go through it again.

Big picture. So you have a competitor out the way that presumably means you'll get more revenue.

What does that mean for your company that's more of a bowl scenario maybe than you originally contemplated so how do you put that money to work in a long right and then second just a question I'm sure you her all the time, let's deal with it on obviously.

Steven L. Hoerter: And then second, just a question I'm sure you hear all the time, but let's deal with it. Obviously, I've seen other drugs do better in the real market than they do in their clinical trials. So does SUTN do better after a few years in the market? So would SUTN data look better today than it did when it launched? So that goes to the point in which you said there's a two to three month difference between SUTN on second line and PFS. And would that be enough to get stats?

Seen other drug do better in the rail market that make you enter clinical trials. So this will do better after a few years in the market. So it's Steven data look better today than it did when it launched so that goes to the the powering which extended the two to three much different from it and in second line, a PFS and would that be enough to get Scott.

I think that the concerns that investors had.

Steven L. Hoerter: I think that's a concern investors have. Yeah, Robin, thanks. It's Steve. Let me take those two.

Yeah, Robyn thanks, it see it let me let me take those too so that ill start with the second question first with respect to Sunitinib.

So as you know when you look at the Sunitinib label and the data that was generated that was the basis for approval. The PFS seen with Sutent was just shy of six months and that pivotal study and when you look at the literature you of course see a range of different PFS estimates, depending on the study and listened very small study some larger studies that have been done.

And that in the time when the original study was done and from our discussions with thought leaders from around the world very consistently bigger but thought leaders that did manage patients with this disease came back and said that you have six months is the right sort of expectation in terms of how sunitinib might perform in the present day.

In the second one setting so we feel very comfortable with that estimate and then as you know our phase one study, where we had a second line cohort of patients. So at that recommended dose of 150 milligrams once daily.

Which is an end of 31, we have seen a PFS and that patient population of about 10.6 10.7 months. So that with the data of course now that's been generated with Invictus in the fourth line population gives us great confidence and the potential for refresh to perform in the and treat stuff.

Steven L. Hoerter: So with the data, of course, now that's been generated with Invictus and the fourth line population gives us great confidence in the potential for Repretnib to perform in the intrigue study versus Sunitinib and to establish a new standard of care in that line of therapy. So, with respect to your first question, and this is, you know, coming on the heels of the Voyager study failure where Avipritinib underperformed Rigoraphanib in that study. And, you know, as I mentioned earlier in the Q&A, while it's certainly disappointing news for the GIST community that has been waiting for new options for patients, I think it does help to put in context, you know, of course, the data that we generated with Invictus.

The versus Sunitinib and to establish a new standard of care and that line of therapy. So with respect to your first question in this is.

Moving on the heels now of the Voyager study failure were able to Britain underperformed draeger acid in that study and as I mentioned earlier in the queue in a while it's certainly disappointing news for the just community that has been waiting for new options for patients I think it does.

Hello, It does put in context of course, the data that we generated within Victus Tonight I believe.

Steven L. Hoerter: And I believe it firmly signals and establishes that Repretinib has the potential to be best in class in this setting and to be a new standard of care. And so, you know, we look forward to engaging with physicians upon a potential approval, sharing the data with them for those physicians that aren't already familiar with the Invictus data, and hopefully benefiting patients with Rheumatoid arthritis who are in need of additional Oh, and my first question about, you know, your competitors, Don. Obviously, this has to change, like how you think about strategy at the company and how to have a good day. And give you more flexibility to do other things that you want to do.

Certainly.

Signals and establishes the refresh and it has the potential to be best in class in this setting.

Hi, My first question about.

Competitor side, yes.

Obviously this has to change like how do you think about strategy at the company had to be a good day.

Give you more flexibility do other things you want to do any thoughts on that.

Well I think Robyn certainly it's a it's a clearing of that and I think thats, how investors view it as well with the failure of the Voyager study from our point of view, we designed reprinted specifically to address the spectrum of mutations that drive this disease and are in going assumption all along has been that were pregnant.

Steven L. Hoerter: Any thoughts on that? Well, I think Robin, you know, certainly, it's a clearing of that. And I think that's how investors view it as well, with the failure of the Voyager study. You know, from our point of view, we designed Repretinib specifically to address the spectrum of mutations that drive this disease. And our ingoing assumption all along has been that Repretinib would prove to be best in class in this setting and this disease. And so at some level, of course, while you're, you know, it's helpful to see final data that that data confirms what our ingoing set of assumptions were in terms of how Repretinib is truly best in class here. So, you know, we look forward to continuing to explore the role of Repretinib in other settings in GIST to see where Repretinib may be able to benefit patients beyond the intrigue study in the second line. So that includes looking at the frontline setting, whether it be monotherapy or in combination with other agents. We certainly think there are additional places that we can go with Repretinib in GIST.

I would prove to be best in class in this setting and this disease and so at some level of course, while you're it's helpful to see final data.

That that data confirms what are in going set of assumptions were in terms of how were pregnant.

Is truly best in class here. So we look forward to continue to explore the rollover printed and other settings and just to see where repricing that may be able to benefit patients beyond the intrigue study in the second line. So that includes.

Looking at the frontline setting whether it be in monotherapy or in combination with other Asia. We certainly think there are additional places that we can go with refreshing that ingest and we look forward to two exploring that further and initiating additional studies potential in the future.

Steven L. Hoerter: And we look forward to exploring that further and initiating additional studies in the future. Okay, thank you. And your next question comes from the line of Chris... Christopher Moret with Nomura, Hello, this is Jackson Harvey on behalf of Christopher Mirai. My first question is, when the repregnant launch does get underway, what kinds of launch metrics do you plan on sharing? Will we be able to get any color on which line of therapy the patients are on? Hey, Jackson. It's Steve.

Okay. Thank you.

Your next question comes from the line of Chris Tomorrow, Christopher Marai with Nomura Instinet.

Hello. This is Jackson Harvey on for Chris to Primorye. My first question is when the repressed net launched does get underway what kinds of launch metrics do you plan on sharing well, we'd be able to get any color on with which line of therapy. The patients are out.

Steven L. Hoerter: Thanks for the question. Yeah, it's a little early for us to share what the launch metrics would be for Reprentant. So once we get on the other side of a potential approval, we'll start to share how we're going to be tracking performance of Reprentant in the marketplace, and we'll share some of that information with investors.

Hey, Jackson assays. Thanks for the question, Yes, a little early for us to share what launch launch metrics would be for pregnant. So once we get on the other side of a potential approval, we will start to share how we're going to be tracking performance of recruitment in the marketplace and we will share some of that information.

With investors.

Got it and my other question is on where best to NIM.

Steven L. Hoerter: And my other question is on ribastinib, around the muscular weakness side effects. So at the 50 milligram dose, are you able to dose through this side effect? Meaning that the muscular weakness will get better with continued dosing? Or is it something that patients need to discontinue treatment for?

Around the muscular weakness side effects. So at the 50 milligram dose <unk> are you able to dose through this side effects, Ed meaning that the muscular weakness will get better with continued dosing or is it something that patients need to discontinue treatment for also it does that have.

In the cardiac ramifications. Thank you.

Yes. Thanks, Thanks, Jackson, so I'll turn that over some that he'd like to answer that question Matt.

Steven L. Hoerter: Also, does that have any cardiac ramifications? Thank you. Yeah, thanks. Thanks, Jackson.

Sure. So no. Thanks for the question. So yeah, what we've reported previously in the Paclitaxel. We've got some combination study was the initial phase.

Matthew L. Sherman: So I'll turn that over to Matt, if you'd like to answer that question. Sure, so, you know, thanks for the question. So, you know, what we've reported previously in the Paco-Taxel Combination Study, the Basin Combination Study, was, you know, the initial phase 1-2 study was dose ranging across 50 and 100 milligrams of Basin with BID. And in that setting, we saw, you know, fairly equal and lower rates of muscular weakness in those two cohorts. When we started the expansion cohorts with 150 milligrams BID, we did see some... a few more cases at 100 mg BID, so we modified the dose down to 50 mg BID, which is what we just discussed today as well for the carboplatinum combination study. When those patients are discontinued, they can actually recover fairly quickly from muscle weakness. However, really, for longer-term treatment, I felt that the 50 mg BID dose level was a more tolerable dose level. And this is really in the background to the fairly robust activity that we saw in the Paclitaxel combination study with eight partial responses across those two dose levels. This is called peripheral muscle weakness.

One to study was dose ranging Chris 60, and 100 milligrams of investment the I'd and that setting the we.

Saw fairly equal and lower rates muscular weakness in those two cohorts. When we started the expansion cohorts with 150 milligram the I'd and we did see some.

Well a few more cases, a 100 milligrams guarantee so we modified the dose down to 50 milligrams JP, which is what we just discussed today as well for the couple appointment combination study when those patients are just continue to actually can recover really quickly from the muscle weakness however, really for for a longer term treatment built at the 50.

Milligram be I'd dose level optimism worked hard tolerable dose level and this is really on the background, but fairly robust activity that we slightly.

And the Paclitaxel combination study with a partial responses across those two dose levels.

Well. This is not this is peripheral muscle weakness is not associated with cardiac.

Matthew L. Sherman: It is not associated with any cardiac muscle effect. Got it. And is there a mechanistic basis to expect that cardiac muscle would not be affected?

And the cardiac muscle effects.

Got it and is there a mechanistic basis to expect that cardiac muscle would not be affected.

No we haven't really talking about any specific mechanism that could be associated with this so that would certainly be.

Matthew L. Sherman: Yeah, we haven't really talked about any specific mechanism that could be associated with this. So that would certainly be a conversation as we go forward with the development program, but there's no known target that we can identify that would make us believe that cardiac muscle is involved. Great, thanks for taking the question. And your last question comes from the line of Orlando Lee with Canon Corp. Your line is open, Arlinda Lee.

You know a conversation perhaps as much as we go forward with the development program, but there is no known target that we can identify that would make us believe that the cardiac muscle is involved.

Great. Thanks for taking the question.

Well.

And your last question comes from the line of Arlinda Lee with Canaccord.

And your line is open Orlando.

Sorry, I was on mute.

Steven L. Hoerter: I wanted to follow up on the intrigue. You mentioned previously that it was due to, um, wondering if, given COVID, you put any other assumptions within that and how. I was curious about your interactions with your thought leaders and sales with prescribers. Hey, Linda, it's Steve. Thanks. Thanks for the two questions. So maybe what I'll do is ask Dan Martin to take the first question in terms of what we're hearing from thought leaders and from some of the secondary research that he referenced in his prepared remarks in the context of COVID-19. And then we can we can come back, and I can I can answer the question with respect to intrigue, and that can offer some additional color. So Dan?

I wanted to follow up on the intrigue.

Population increase.

You mentioned previously that do you or too early censoring lender you.

Given co bid and maybe some of the.

If you put any other assumptions within that and how preparing may or may not have changed and then secondly.

Curious about your interaction with your thought leaders sale.

With prescribers that how this might have been different now with.

Following.

The interpretative wager failure.

Yes, Maryland to see thanks, Thanks for the two questions. So maybe what I'll do is to ask Dan Martin to take the first question in terms of what we're hearing from thought leaders and from some of the secondary research that he reference in the prepared remarks in the context of cope with 19 and then we can we can.

Come back and I guess I can answer the questions with respect to intrigue and Matt can offer some additional color so Dan.

Sure. Thanks, Steve So couple of thoughts.

Daniel C. Martin: Sure. Thanks, Steve. So, a couple of thoughts. You know, we have been continuing to engage. We've continued to hold advisory boards. We've continued to have our one-on-one discussions.

We have been continuing to engage.

Salt leaders medical community that just prescribing community more broadly very actively over the last several months as.

Daniel C. Martin: We do these through virtual platforms, of course, but we've had really great engagement that has helped inform our thinking not only on positioning for a vaccine but thoughts on strategies, tactics, that sort of thing. As I mentioned in my prepared remarks, this would suggest that oncology has had some level of resilience just in terms of treatment volume, but clearly, it's having an impact on patient visits. And it may, you know, ultimately, have some impact on launch therapy, launch drugs in terms of rate of uptake, and we'll just have to see.

[noise] Cobot 19 situation has developed we've continued to hold advisory boards.

We continue to have our one discussions we do these three virtual platforms of course, but we've had really great engagement.

That has helped inform our thinking not only on.

Positioning for Britain into the market, but thoughts on.

Strategies tactics that sort of thing.

A lot of the research that we've looked at.

As I mentioned in my prepared remarks, which suggests that oncology at some level of resilience.

Just in terms of.

Treatment treatment volumes.

Clearly, it's having an impact on patient visits on and it may ultimately.

Have some impact on launch therapy.

Launch drugs in terms of rate of uptake and we'll just have to see.

Daniel C. Martin: But beyond that, beyond what I shared in the prepared remarks, that's really what we're hearing. Yeah, thanks, Dan. So, Orlinda, hopefully that answers that second question that you had. With respect to intrigue, you're right, we disclosed today that the N for intrigue is 426 subjects. So, just wanted to be clear that the addition of these subjects to intrigue has no impact on the powering of the study.

But but.

Beyond that beyond what I shared in the prepared remarks.

And.

That's really what we're here.

Yes, thanks, Dan So Orlando for that answers that second question that you had with respect to intrigue, you're right. We disclosed today that the end for intrigue US 426 subjects. So just wanted to be clear that. The addition of these subjects to entry has no impact on powering of this.

Hi, This is just about getting to the requisite number of events for the study to have those study readout in a timely fashion and that maybe you want to offer some additional commentary with respect to.

Steven L. Hoerter: This is just about getting to the requisite number of events for the study to have the study read out in a timely fashion. And, Matt, maybe you want to offer some additional commentary with respect to the impact of COVID-19 and other considerations that may have been taken into account as we thought through this. Thanks, Steve. So, as you know, as we had the early information about the number of patients that we're looking at early in the study, you know, who, [inaudible] This, you know, the implementation of the processes we put into place, you know, again, we feel very comfortable during this particular unusual time of the COVID-19 pandemic. And, you know, with the team being in close communication with investigators and the sites and able to, you know, implement local procedures as well, we still feel very comfortable being able to collect the information that will be necessary to evaluate the effect of a relevant drug in the second line setting.

Impact of Coven, 19, and other considerations that they have been taken into account as we thought through this.

Thanks, Steve So yes, so you know as as we had the erosion from it's just about the.

A number of patients that were pushing the early in the study who.

I might have come off the study in Didnt have central confirmation of progression.

Gave us a better estimate in terms of the overall sample size.

Certainly as Steve mentioned, this very obvious increasing sample size.

No no allow us to get to the required number events. It's just not changed the statistical analysis plan.

This.

The improvement implementation of the process as we put into place you know again, we feel very comfortable during this particular unusual time to cook at 19 pandemic and with the team being close communication with investigators and the sites in April two implementation local procedures as well, we still feel very comfortable up.

You are able to collect information will be necessary to evaluate the effect of are putting that in second line Chuck.

Great. Thank you.

Thanks, I wanted to.

Matthew L. Sherman: Thanks, Rolanda. And this concludes today's Q&A session. I would like to turn the call over to Steve Hoerter for closing.

Steven L. Hoerter: Yeah, thank you very much, Frederica, and thanks to all of you for joining us on the call today. We look forward to continuing to update you on our progress as the rest of the year progresses, and we wish each of you safety and good health in these challenging times. Have a great night. Ladies and gentlemen, this concludes today's conference call. Thank you for participating.

And this concludes todays queuing nice session I would like to turn the call over to Steve harder for closing remarks.

Yes. Thank you very much frederica and thanks, all of you for joining us on the call today.

Look forward to continued updates you on our progress as the rest of year Progressive and we wish each of you safety in good health. These challenging times have a great.

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

Q1 2020 Earnings Call

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