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Edited Transcript of TPTX.OQ earnings conference call or presentation 12-May-20 8:30pm GMT

Q1 2020 Turning Point Therapeutics Inc Earnings Call

Jun 22, 2020 (Thomson StreetEvents) -- Edited Transcript of Turning Point Therapeutics Inc earnings conference call or presentation Tuesday, May 12, 2020 at 8:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Athena Maria Countouriotis

Turning Point Therapeutics, Inc. - President, CEO & Director

* James S. Mazzola

Turning Point Therapeutics, Inc. - SVP of Corporate Communication & IR

* Yi Larson

Turning Point Therapeutics, Inc. - Executive VP & CFO

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Conference Call Participants

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* Arlinda Anna Lee

Canaccord Genuity Corp., Research Division - Analyst

* Corinne Jenkins

Goldman Sachs Group Inc., Research Division - Research Analyst

* James William Birchenough

Wells Fargo Securities, LLC, Research Division - MD and Senior Biotechnology Analyst

* Michael Werner Schmidt

Guggenheim Securities, LLC, Research Division - Senior Analyst & Senior MD

* Robert John Burns

H.C. Wainwright & Co, LLC, Research Division - Associate

* Zegbeh Claudel Jallah

Roth Capital Partners, LLC, Research Division - Director & Research Analyst

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Presentation

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Operator [1]

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Ladies and gentlemen, thank you for standing by, and welcome to the Turning Point Therapeutics First Quarter 2020 Conference Call. (Operator Instructions)

I will now like to hand the conference to your speaker today, Jim Mazzola. Please go ahead, sir.

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James S. Mazzola, Turning Point Therapeutics, Inc. - SVP of Corporate Communication & IR [2]

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Good afternoon, everyone. Following market close today, we filed our Form 10-Q and issued a news release with a summary of our results for the first quarter of 2020. We also updated our investor presentation. You may find these documents posted on the investor pages of tptherapeutics.com.

Leading the call today will be Turning Point's President and Chief Executive Officer, Dr. Athena Countouriotis, who will provide an overview and update on our business results, including our response to the COVID-19 pandemic. Athena's remarks will be followed by a review of our financials by our CFO, Yi Larson. We will take questions following our prepared remarks.

As a company, we are adhering to guidelines for social distancing and remote work. And therefore, the 3 of us are in different locations today. We have previously recorded our prepared remarks, after which we will host a live Q&A session. So please bear with us that this modified approach results in any technical issues.

Before Athena begins, I want to remind you that during this conference call, we will be making forward-looking statements. The company's actual results may differ materially from those expressed in or indicated by such forward-looking statements. For a description of risk factors associated with investing in Turning Point Therapeutics, please refer to our recent filings with the Securities and Exchange Commission.

Now let me turn the call over to Athena.

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Athena Maria Countouriotis, Turning Point Therapeutics, Inc. - President, CEO & Director [3]

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Thank you, Jim, and good afternoon to everyone joining us today. Before I begin, I want to acknowledge how incredibly challenging this past quarter was for so many in our society and especially thank each and every one of the dedicated health care providers who have made so many sacrifices these past few months for the health and well-being of patients worldwide.

Despite the challenges, we have remained focused on our goals to bring meaningful therapies to patients in need while navigating the rapidly evolving situation with COVID-19. I am incredibly proud of the progress our team made during the quarter and pleased to now provide an update on the quarter and our response to that pandemic.

For anyone new to our story, at Turning Point, we have internally discovered and developed our wholly owned pipeline of next-generation tyrosine kinase inhibitors that target numerous genetic drivers of cancer. Today, we have 4 active development programs with the potential to address up to 15% of the targeted therapy opportunity in advanced non-small cell lung cancer, if each of our drug candidates are utilized as single agents.

Starting with repotrectinib and specifically the TRIDENT-1 Phase II study. In the first quarter, we remain pleased with the rate of global site activations with approximately 50% of our sites now activated across 11 countries. This includes the majority of our U.S. sites and key sites in Europe and the Asia-Pacific region. The Phase II portion of TRIDENT-1 is expected to enroll approximately 320 patients, now it up to 120 sites globally. In addition, we continue to anticipate providing early interim data from initial patients in some of the registration cohorts during the second half of the year. I will provide additional detail for that update as I walk through our upcoming milestones.

We also recently completed our first independent data monitoring committee meeting for the TRIDENT-1 on study. The DMC is responsible for the oversight of the overall trial conduct and safety profile of repotrectinib within the Phase II portion of the study. Their recommendation, based on the initial safety evaluation, was for the study to continue. While it is not our standard practice to give periodic updates on enrollment in our ongoing registration trial, I remain pleased with the progress we made during a very challenging first quarter. We took multiple steps to help mitigate the impact of the pandemic, which included remote site activation and data monitoring, enabling patients to have routine tests conducted closer to home and allowing sites to evaluate certain patients remotely by phone or videoconference. These measures were implemented in collaboration with our CROs, our sites and their IRBs.

In addition, we have also evaluated additional sites for participation in our Phase II TRIDENT-1 study. Importantly, we have not experienced any COVID-19-related supply interruptions to our clinical programs. Despite the steps to mitigate the impact of COVID-19, we have more recently started to experience delays in trial site initiations and patient enrollment within the TRIDENT-1 study. We are also closely watching the progress in our other studies and believe the extent of the impact on our pipeline will depend on the continued duration and severity of the pandemic.

Turning to our 3 earlier-stage studies. First, we have an ongoing Phase I/II open-label study to assess repotrectinib in pediatric patients with ALK, NTRK or ROS1-positive advanced solid tumors. We continue to advance that study with site activation and patient enrollment.

Next is our Phase I open-label study of TPX-0022, our MET, CSF1R and SRC inhibitor, in patients with advanced solid tumors harboring genetic alterations in MET. As a reminder, the study is a standard dose-escalation design to determine the maximum tolerated dose, overall safety profile and preliminary efficacy of TPX-0022. The study has enrolled both TKI-naive and pretreated patients with primarily exon 14 alterations or MET amplifications. And we anticipate reporting early interim data from initial patients in the second half of 2020. To help guide expectations, we anticipate this update will be primarily a safety update as well as any early efficacy signals as we continue through our dose-escalation cohorts.

Next in our pipeline is TPX-0046, our RET/SRC inhibitor. We are encouraged by the potential for TPX-0046 based on its preclinical potency against wildtype KIF5B-RET and solvent-front mutations, including G810R and S. For reference, recent data published in the Journal of Thoracic Oncology in a total of 11 RET-positive patients treated with the RET inhibitor, selpercatinib, indicated the rate of solvent-front mutations was approximately 45% or 5 of 11 patients.

While preliminary, these data are consistent with the prevalence of solvent-front mutations observed in other oncogenic drivers, including ROS1, TRK and ALK. The dose-escalation portion of our ongoing Phase I/II study of TPX-0046 is progressing with enrollment, including both TKI-naive and pretreated patients, and patients with solvent-front mutations previously treated with other investigational RET inhibitors. The study is designed to enroll patients with RET-altered non-small cell lung, thyroid and other advanced cancers.

Lastly, in our pipeline is TPX-0131, our next-generation ALK inhibitor candidate. We announced in January its nominations enter IND-enabling studies with the goal of submitting an IND by early 2021. TPX-0131 has been designed with a compact macrocyclic structure and in preclinical studies has been shown to potently inhibit wildtype ALK and numerous ALK mutations, in particular, the clinically observed G1202R solvent-front mutation and G1202R/L1196M compound mutation. We are excited to advance this drug candidate as quickly as possible and have remained on track with preclinical activities during the pandemic.

From our programs, we have milestones anticipated during 2020, and I will now provide an update of our progress towards each. First, as a reminder, we have guided to providing early interim data from initial patients in some of the registration cohorts of the TRIDENT-1 Phase II study during the second half of the year. We are currently monitoring the overall study conduct and data collection to be in a position to potentially provide this update in the third quarter. At this time, we anticipate sharing preliminary efficacy and safety data as it relates to overall responses likely by physician assessment in approximately 30 to 40 patients across multiple Phase II cohorts, including our registrational and exploratory cohorts. This will allow us to potentially evaluate a data set at our Phase II dose in our global Phase II study that is comparable in size to our Phase I ROS1-positive efficacy evaluable population. We are monitoring this very closely, and our goal, given the uncertainty of medical conferences, would be to provide this update with a news release and subsequent call. As I said earlier, for the TPX-0022 data update, we anticipate the initial update will focus primarily on safety as well as any early efficacy signals as we progress through our dose-escalation cohorts.

Moving to our next upcoming milestone. We were pleased to have several abstracts accepted for presentation at the ASCO and AACR virtual annual meetings. Our ASCO poster will be a preclinical update for TPX-0046 scheduled for presentation on May 29, with abstracts planned for release tomorrow by ASCO.

For AACR, we will present preclinical repotrectinib combination data and preclinical data for TPX-0131. We can now confirm that these poster presentations will be shared in late June at the second AACR virtual meeting. AACR plans to release abstracts for the presentations later this week, which should indicate the date and time of our presentations. The preclinical data for TPX-0131 is part of our ongoing work towards our goal of an IND submission by early 2021.

Now let me turn the call over to Yi for an update on our financial results.

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Yi Larson, Turning Point Therapeutics, Inc. - Executive VP & CFO [4]

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Thank you, Athena. You will see in our press release and financial tables that operating expenses for the first quarter were $62.6 million and included a onetime noncash stock-based compensation expense of $31.4 million associated with modifications to the vesting of existing stock option grants as a part of the transition agreement of the company's scientific founder. Excluding this onetime item, non-GAAP operating expenses in the first quarter totaled $31.2 million compared to GAAP operating expenses of $14.1 million, in Q1 of 2019 and $23.1 million in the fourth quarter of 2019. Primary drivers of the year-over-year increase were investments made to develop repotrectinib and the rest of our pipeline, including the head count we have added.

Reported operating expenses included a total of $38.4 million in noncash stock-based compensation expenses primarily comprised of the $31.4 million onetime item. We continue to expect expenses in 2020 will increase as we execute across 4 clinical trials for our 3 clinical-stage assets and make investments to develop our ALK program and earlier-stage discovery efforts.

Net cash used during the first quarter was $28.4 million; and our cash, cash equivalents and marketable securities at March 31 were $380.8 million. We project our cash position will fund current operations into 2022.

With that brief update, I will turn it back to Athena.

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Athena Maria Countouriotis, Turning Point Therapeutics, Inc. - President, CEO & Director [5]

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Thank you, Yi. To close, I will summarize our goals for the year which are: Advancing enrollment in each of our clinical trials. The extent of the COVID-19 impact on our clinical trial enrollment and data collection will depend on the duration of the pandemic. This is a clear area of focus for our team. Presenting a preclinical update for TPX-0046 at the virtual ASCO meeting on May 29. Presenting our preclinical repotrectinib combination data and our preclinical data for TPX-0131 and at the virtual AACR meeting in late June. Providing an update of early interim data from initial patients in the TRIDENT-1 Phase II study during the second half of the year, potentially in the third quarter. We anticipate this update will include preliminary efficacy and safety data from approximately 30 to 40 patients across multiple Phase II cohorts, including registrational and exploratory cohorts. Providing interim data from initial patients treated with TPX-0022 during the second half of the year and advancing TPX-0131 towards IND submission, which we anticipate in early 2021.

Again, I want to thank our great Turning Point team for all they accomplished so far this year. This has been a challenging time with many rapidly evolving variables, yet our team adapted well and remains incredibly focused on delivering our pipeline to patients.

Operator, you may now open the line for questions.

Good afternoon, everyone. In addition to what we've outlined in our prepared remarks, earlier today, we announced that repotrectinib has been granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of ROS1-positive advanced non-small cell lung cancer patients who have not been previously treated with a ROS1 tyrosine kinase inhibitor. As a reminder, in January, repotrectinib was granted Fast Track designation for the treatment of ROS1-positive advanced non-small cell lung cancer patients who had been previously treated with one prior line of platinum-based chemotherapy and one prior line of a ROS1 TKI, a setting where there are currently no approved targeted therapies.

Our latest Fast Track designation was granted in ROS1-positive TKI-naive non-small cell lung cancer patients utilizing a July 22, 2019, data cut-off date with a median follow-up of 20.1 months. Repotrectinib demonstrated a confirmed overall response rate by blinded independent central review of 91% or 10 of 11 responders, with a median duration of response of 23.1 months. This is based on a Kaplan-Meier estimation. The probability of patients with a duration of response of greater than 9 months was 78%; greater than or equal to 12 months, 65%; and greater than or equal to 18 months, also 65%, respectively. Repotrectinib also showed a median progression-free survival of 24.6 months, which, while not an end point of the Phase I study, compares favorably with historical comparisons for the 2 currently approved agents in this setting.

As of April 6, 2020, with an additional 8.5 months of follow-up, 4 of the 5 responding ROS1 TKI-naive patients remained in a partial response per physician assessment data since the July 22, 2019, data cutoff. And the duration of treatment ranged from 9.2 to 34.2-plus months, with 7 of the total 11 or 64% of patients remaining on repotrectinib. All 7 patients remained on treatment for more than 17 months, 6 or 55% on treatment for more than 2 years and 3 or 27% on treatment for more than 30 months at the time of the analysis.

In addition, repotrectinib has also demonstrated CNS activity among patients with ROS1-positive advanced non-cell lung cancer, who are ROS1 TKI naive, with intracranial objective response rate of 100%, 3 of 3 patients; with durations of response as of the July 22 data cutoff of 14.8-plus, 17.6-plus and 23.1 months. All 3 of these patients remain on treatment as of the April 6, 2020 analysis, 26-plus months, 28.5-plus months and 34.2-plus months, which is very encouraging given the limited therapeutic options for patients with CNS disease in this setting.

With that additional information from our Phase I TRIDENT-1 study and our recent Fast Track designation now outlined, we may now open the line up for questions, operator. Thank you.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question comes from Paul Choi with Goldman Sachs.

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Corinne Jenkins, Goldman Sachs Group Inc., Research Division - Research Analyst [2]

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This is Corinne Jenkins on for Paul. I was wondering if there's anything you'd point out on the Retevmo label that was approved last week and whether you see any potential impact to the ongoing enrollment in your study of 0046 with the availability of an approved product to [RET]?

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Athena Maria Countouriotis, Turning Point Therapeutics, Inc. - President, CEO & Director [3]

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Thank you for the question. So I hope everything is okay with you and your family. Last week was a busy week, obviously, with 2 approvals in the targeted oncology space. And I think we all anticipated the approval of selpercatinib, or Retevmo, as you've outlined. I think I've consistently always said that I think it's a very good drug. I think those that may have detected changes as it relates to duration of response and/or warnings and precaution information, I'll leave that debate to them. But we've always been focused on how our drug differentiates. I think one of the ways it clearly differentiates is also its selectivity as it relates to SRC and potentially to the safety component that we do not hit the VEGF tree and specifically VEGFR2. So there may be areas that we can differentiate versus the warnings and precaution labeling.

As it relates to the impact, one of the things that we were incredibly pleased with through the first quarter as well as moving into the second quarter is how our Phase I studies have progressed. I think that's a testament to not only, again, the way that our molecules hopefully differentiate, which goes beyond just 0046, but also that we have a global setting for our MET inhibitor for that Phase I study and also multiple sites for the RET program that you're asking about. So an overall impact for the future is hard to predict. I think equally, as we've outlined from the duration of the pandemic. But so far, we've been very pleased with enrollment for not only the RET program but our other Phase I studies, which include the MET.

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Corinne Jenkins, Goldman Sachs Group Inc., Research Division - Research Analyst [4]

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Great. And then I would imagine the conferences like the ASCO and ACCR often a good time for you to connect with KOLs that become involved in clinical trials. And I was just wondering if you could talk about how you're kind of maintaining some of those touch points, given the shift to a lot of virtual engagement.

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Athena Maria Countouriotis, Turning Point Therapeutics, Inc. - President, CEO & Director [5]

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One of the things I would say is many of the KOLs have also unfortunately been adapting to the new environment and have been at home much more than they would have normally been. And so I've been just as much online with some of the KOLs who might have been more focused on clinic in the more recent past. So I really don't believe that any engagement has changed, at least from my perspective or -- obviously, Mohammad, our CMO, has been incredibly engaged across all of our 4 ongoing programs. I think to your point that you're right, it's unfortunate that we don't get the face-to-face for many of the major medical conferences. But I don't think in any way that deters or distracts us as it relates to trying to connect with our key investigators as it relates to new drugs that are approved or obviously, our ongoing studies.

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Operator [6]

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Our next question comes from Jim Birchenough with Wells Fargo.

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James William Birchenough, Wells Fargo Securities, LLC, Research Division - MD and Senior Biotechnology Analyst [7]

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Congrats on the progress through the difficult environment. I guess, first, just on TRIDENT-1, going from 100 to 120 sites, is that just to offset the impact of COVID-19? Or is there anything in terms of screening for ROS1 and NTRK-positive patients that you're seeing different than you'd assumed previously?

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Athena Maria Countouriotis, Turning Point Therapeutics, Inc. - President, CEO & Director [8]

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No. Thanks for the question, Jim. Same comment I made to Corinne, I hope everything is okay for you and your family. First, I would say that we were making the decision to evaluate additional countries throughout the conduct of the trial. Just looking back, of course, I've given a lot of detail to a Phase I update in the context of our Fast Track designation that was granted today. So I appreciate that's all new data. But to try to remind folks, our Phase I study was really 7 sites, 2 countries. And so the Phase II is just such a much more global scale program, and we've been evaluating over time what additional countries we may or may not bring into the trial. So going from 100 to 120 actually included additional sites at the prior countries that we had selected as well as some new countries that we've selected, as we've learned more through outreach, to payables in those areas as well as outreach with our CRO. But also to the point that you're making, and I think trying to mitigate any potential impact down the road. We're obviously saying today that we've seen some delay as it relates to site initiations for the Phase II. So adding additional sites, hopefully, will help mitigate that if we can, going [fast] further.

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James William Birchenough, Wells Fargo Securities, LLC, Research Division - MD and Senior Biotechnology Analyst [9]

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And then Athena, just looking ahead to what may be an update in third quarter but certainly second half for TRIDENT-1, can you give us a sense, is it still cohort 2 and 3 where we'd expect the preponderance of patients? And I'm just wondering if, to the extent you have such a strong CNS response, have you enrolled patients that could confirm that activity? And maybe just to set expectations around, what would you expect if it is cohort 2 and 3? What would be your expectations on this number of patients in terms of responses we should look for?

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Athena Maria Countouriotis, Turning Point Therapeutics, Inc. - President, CEO & Director [10]

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Sure. So what we've outlined today and what we said at the beginning of the year was, right now in Q2, we give you more guidance as it relates to what to expect in the second half. And what we've tried to outline is, again, one of the things we said in the prepared remarks is that we're monitoring overall study conduct and data collection. And what I mean by that is, as you know, many sponsors have had to allow greater flexibility right now as it relates to patients potentially having local labs and/or local CT scans collected. It's now in our shop to get that data out of the local institutions into the treating centers and then inevitably into our database.

So what we've said today is that we're potentially going to provide the second half update in third quarter, but we do still have to watch where we are with data collection. And so I can't fully answer whether it will be cohorts 2 and 3. What we've said today is that it will be multiple Phase II cohorts. And at the same time, to the question you've asked about CNS disease, it's too early for me to assess how much data I have collected in patients that have had intracranial disease. When I look at kind of how I should think about the data coming in the second half, it's really probably more to the point I made earlier about the difference between the Phase I study, 2 countries versus now, where we have 11 activated countries. Over half of those countries have now enrolled patients. And so it's clearly a much more global trial, which to some may think that, that would add more variability. And so we want to clearly look at an early number of patients to be able to assess not only a change from 2 countries to a much more global scale but also, as a reminder, our Phase II dose is a regimen that allows titration after 2 weeks of 160 milligrams daily. You can go and double the dose to twice daily. And that we didn't explore in Phase I. We explored it after a shorter period after 7 days.

So my assessment when I think about the data and, again, to the point you've made, which is a relatively small data set, we're looking at approximately 30 to 40 patients, which is consistent. We always said early initial patients. I really just want to see the data, obviously, utilizing our Phase II dose in a much more global scale trial.

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Operator [11]

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Our next question comes from Michael Schmidt with Guggenheim.

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Michael Werner Schmidt, Guggenheim Securities, LLC, Research Division - Senior Analyst & Senior MD [12]

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Athena, thanks for the detailed update today. It looks like the -- based on what you said, the PFS in the front line, [TRK] and ROS1 patient cohort seems to mature really nicely. Good to hear that. I'm just curious if you could also share any updates on potential treatment just discontinuations from the Phase I study as you've taken a look at it more recently.

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Athena Maria Countouriotis, Turning Point Therapeutics, Inc. - President, CEO & Director [13]

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Yes. Thank you for highlighting that, Michael. One of the things we clearly wanted to highlight, of course, we taped our prepared remarks. And so we've received, obviously, very recently the Fast Track designation approval. And so with that, we provided an update to the FDA, not only utilizing the July 2019 data cutoff but also additional information that we've received utilizing physician assessment data. So we've not looked at a formal blinded independent central review analysis since the July update from last year. Having said that, what you pointed out, I think there's 2 points I would point out. Previously, we had said that the maturity of the duration of response was not yet there and so that we had estimated that there was a high likelihood, 65% of it being at least 18 months.

Today, we've now said that the median has been met and the median is 23.1 months, which again, if you're trying to do a historical comparison, remembering crizotinib's duration of response is just over 18 months. I think for progression-free survival at 24.6 months, again, it compares historically to both the approved agents, which are essentially at 19 months. So a delta of -- we were looking at 5.5-plus months. So we're very pleased with the update as it relates to the Phase I. All we've additionally commented on today is that all of the 7 patients remain on treatment, and we gave the extension since what we gave in January as to where patients are with now multiple patients out over 2.5 years on drug and only one patient that was in a previous response that has now subsequently progressed. So that's what we gain in terms of the update as it relates to discontinuation.

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Michael Werner Schmidt, Guggenheim Securities, LLC, Research Division - Senior Analyst & Senior MD [14]

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Makes sense. And then obviously, hard to predict at the moment and really acknowledging the additional sites that you're activating. But any additional color on when you think you might be able to complete enrolling the first registrational cohort? And how we should think about potential filing time lines?

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Athena Maria Countouriotis, Turning Point Therapeutics, Inc. - President, CEO & Director [15]

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No, it's a very fair question. And what we've consistently said is that we would give more guidance as it relates to the time line. So we have not yet given the time line to the Phase II study, yet we would do that as we got closer to full site activation. Today, we've clearly said that we've made progress within the first quarter with now over 50% of our sites activated, but we've seen a little bit of a delay moving into Q2. So it's a little hard to predict right now when we'll hit 100% site activation. But I do still believe that we'll be in a better position to provide you a time line potentially for trial completion once we have all of our sites activated and can truly assess the enrollment curve. So it's a question I can't fully answer today.

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Michael Werner Schmidt, Guggenheim Securities, LLC, Research Division - Senior Analyst & Senior MD [16]

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And then very nice to see the FDA approval recently of Novartis MET inhibitor, capmatinib, with a very broad label, including frontline, based on a very small study. Just wondering how you think about that in terms of read-through to your program and potential longer-term plans with regards to path to market and how we should think about that as well as through the efficacy bar maybe that Novartis sort of pass set at this point.

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Athena Maria Countouriotis, Turning Point Therapeutics, Inc. - President, CEO & Director [17]

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Sure. Yes, last week, as I said before, was a busy week for precision oncology. And I think for those that don't do the math, unfortunately, lung cancer still remains the cancer that unfortunately has the highest rate of death, and it's actually higher than when you add breast, colon and pancreatic altogether. So any advancements within the lung cancer space to me are incredibly positive. So 2 approvals last week was a big win for the field. I think to the point that you're making, the data we've consistently seen is that there are ways we still believe we can differentiate as it relates to potentially prolonging duration of response, with that benchmark of about 12 months in the truly treatment-naive patient population.

Again, I think there were some that might have been surprised by some of the data as it related to the safety profile. And so for us, again, we will be interested when we do provide the update for our MET program, which we've said will still be within the second half. It will predominantly be a safety update and of course, we've always known that there's a high rate of peripheral edema with that asset. And so I think those are the ways when we look at their label, we still have the same belief and conviction we had before, as potentially to how we could differentiate. And then to your point, I think you're correct in the fact that it was a relatively small sample size that led to both of the indications.

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Operator [18]

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Our next question comes from Robert Burns with H.C. Wainwright.

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Robert John Burns, H.C. Wainwright & Co, LLC, Research Division - Associate [19]

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Congrats on the quarter and all the phenomenal progress Turning Point is making. Most of my questions have been answered already but I just want one follow-up. So as we think about the development of all these assets, looking further on down the road and taking into consideration the higher propensity for off-target resistance mechanisms with later-generation TKI inhibitors, are you considering combining these assets with additional agents, for example, an SHP2 inhibitor later on in the development pathway?

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Athena Maria Countouriotis, Turning Point Therapeutics, Inc. - President, CEO & Director [20]

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Yes, sure. Very good question. So I think there was a question earlier as it relates to medical conferences and KOL engagement. I think it's important for us to highlight that we do have at least between the 2 conferences, ASCO, there'll be predominantly a preclinical update as it relates to our RET program. But AACR, at the end of June, will really be the first place where we start to show our combination strategy. We've talked about this for quite a while now. We've continued to work on it. We've built our team to evaluate multiple ways that we can combine, at least our lead assets, repotrectinib. But we're fully aware that there is another investigational RET inhibitor that's now being combined with an EGFR inhibitor. So I think to your point, we are looking at our entire pipeline and combinability with other targeted therapies, whether it's TKIs or others, but just something that we haven't necessarily shown publicly. But again, AACR abstracts will be coming out very soon. And then subsequently, obviously, the presentation.

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Operator [21]

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Our next question comes from Jim Birchenough with Wells Fargo.

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James William Birchenough, Wells Fargo Securities, LLC, Research Division - MD and Senior Biotechnology Analyst [22]

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Just maybe a broader question. As you think about the profile, Athena, of your drugs where you're hitting the wildtype mutation and the solvent-front mutations, are there good categories that you can point to where that becomes the preferred front line approach. Is Tagrisso/Tarceva in lung cancer, an example? I just want to get a sense of as we start to think about what's going to be the dominant front-line agent over time in things like non-small cell lung cancer, if there's some precedent for something that hits wildtype and in prominent resistance mutations.

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Athena Maria Countouriotis, Turning Point Therapeutics, Inc. - President, CEO & Director [23]

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Yes. Sure, Jim. I think Tagrisso is a very good example, of course, for one that started in T790M and then moved clearly to the front line based on its potency. One of the reasons, and I know we've been asked repeatedly and so I hope today's update will be perceived positively as the Phase I update for TKI-naive patients showing now the DOR of close to 2 years and 23 months and showing median PFS of over 2 years where the competitors are at 19 months. I still think, again, it's the strongest data set that we have to show why we believe repotrectinib is a best-in-class agent. And clearly, that's a drug that hits wildtype as well as is the only currently that has activity in the clinic against solvent-front mutations.

So when we think about other benchmarks out there, we often use the example that you've outlined in Tagrisso. Sometimes we'll also look at ALCANZA, given the fact that it started in a different setting and now has really become the front-line agent for ALK-positive non-small cell lung cancer. But I think it's a very fair point to think of how we think each of our molecules not only differentiate for treatment resistance but also to be best in class.

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Operator [24]

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(Operator Instructions) Our next question comes from Zegbeh Jallah with ROTH Capital Partners.

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Zegbeh Claudel Jallah, Roth Capital Partners, LLC, Research Division - Director & Research Analyst [25]

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Just wanted to ask a quick question about any regional differences in the enrollment for TRIDENT and then kind of get a sense of how that may overlap with sites where you're seeing more of an impact of COVID-19.

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Athena Maria Countouriotis, Turning Point Therapeutics, Inc. - President, CEO & Director [26]

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Yes. Thank you for the question. So first, I think as it relates to the Phase I versus the Phase II, let me just say from the Phase I component, it was 2 countries, so United States and South Korea. The largest enroller within the Phase I was here within the United States at Sloan Kettering. Our Phase II, we've not given any guidance as it relates to periodic enrollment or where enrollment is coming. But what I did say today is we have 11 activated countries now and over half of them have enrolled patients within the Phase II. So I haven't given you specifically the countries, but I've at least given you information to say that it is a broad base of where enrollment has already started within the Phase II study. So that's the best way that I could answer the question as it relates to enrollment as of today.

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Zegbeh Claudel Jallah, Roth Capital Partners, LLC, Research Division - Director & Research Analyst [27]

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That's helpful. And then another follow-up here. I just wanted to also get a sense of how many scans, what the median treatment duration will likely be for the data update that might happen in 3Q for TRIDENT Phase II?

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Athena Maria Countouriotis, Turning Point Therapeutics, Inc. - President, CEO & Director [28]

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See that's something that we're currently evaluating now, given the fact that we have multiple patients who have data that are still being collected from local institutions, so I wouldn't be able to give you any further guidance as to whether patients will have more than 1 or 2 post-baseline scans in the context of what the update will be because it will also be dependent on when the update will be, whether it will be in Q3 or later in the second half.

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Operator [29]

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Our next question comes from Arlinda Lee with Canaccord.

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Arlinda Anna Lee, Canaccord Genuity Corp., Research Division - Analyst [30]

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I have maybe -- I was looking for maybe additional color on some of the data sets that we might be expecting towards the end of the year. You mentioned that you were looking for 30- to 40-ish patients in exploratory and registrational arms. I was curious since the trial started late last year -- or sorry, middle of last year, I think, are those patients then going to largely not be impacted by COVID? And then I was curious about if you anticipate any issues from requiring biopsies fresh versus maybe archival and whether there's any change to the workup of these patients during this time?

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Athena Maria Countouriotis, Turning Point Therapeutics, Inc. - President, CEO & Director [31]

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Yes. Thanks for the questions, Arlinda. We actually had previously guided and have outlined it again in some of our documents that currently for enrollment, patients can come in with local testing. So there is no current requirement for a fresh biopsy, of course, unless the patient is a naive patient who's just recently been diagnosed. So the biopsy components, hopefully, is not a barrier for patients that are coming through within the trial.

The impact as it relates to the data analysis, again, it will be partially based on the last question as to where we are with current scans and where the patients were in their treatment paradigm to fully be able to answer your question. So I can't answer entirely whether any of the patients that will potentially be in the data set will have had scans during this time. More than likely, they would have. But again, the question I think that you're asking is patients that were had enrolled, your time line was correct. The phase enrolled started in July of last year, predominantly early patients versus more recent patients. Again, while we're looking at overall conduct and data collection, it's a question that's hard to answer right now.

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Operator [32]

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I'm not showing any further questions at this time. I would now like to turn the call back over to Athena Countouriotis for closing remarks.

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Athena Maria Countouriotis, Turning Point Therapeutics, Inc. - President, CEO & Director [33]

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Well, thank you, again, everybody, for dialing in. I really appreciate the time and obviously, your interest and support in Turning Point Therapeutics. Given the company is under the stay-at-home directive, I know many of our employees are at home. And so I thank you for everything that you have been doing. You know that. I hope you and your families stay well during all of these unprecedented times. And operator, you may now close the call. Thank you.

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Operator [34]

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