Turning Point Therapeutics, Inc.
Q3 2021 Earnings Call Transcript

Published: 9 Nov 2021

[Operator:]

Good day. And thank you for standing by. Welcome to the Turning Point Therapeutics Third Quarter 2021 Conference Call. At this time, all participants are in a listen-only mode. After the speakers' remarks, there will be a question-and-answer session. . I would now like to hand the conference over to your speaker today, Adam Levy. Thank you. Please go ahead.

[Adam Levy:]

Thank you, operator. Good afternoon, everyone. First, let me start by saying I'm happy to be on the call today and to be joining the Turning Point team at such an exciting time for the company. I also want to thank Scott Lipman for managing our Investor Relations activities recently, and I look forward to working with many of you going forward. Following market close today, we filed our Form 10-Q and issued a news release with a summary of our results for the third quarter of 2021. We also updated our investor presentations. 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 of our business results, before turning the call over to Paolo Tombesi, our Chief Financial Officer, for a review of our financials. We will take questions following our prepared remarks. And we'll be joined by Mohammad Hirmand, our Chief Medical Officer. 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 update over to Athena.

[Athena Countouriotis:]

Thank you, Adam. And good afternoon to everyone joining us on today's call. As this is our last quarterly call in 2021, I want to start by highlighting what I believe to be the true strength of our Turning Point team. In the past three years, we have advanced our macrocyclic platform from one Phase I clinical stage asset in one ongoing clinical trial to now four clinical stage assets in six ongoing clinical trials. In addition, we have received a total of nine regulatory designations for our pipeline, including two breakthrough therapy designations for our lead asset, repotrectinib. Our company has scaled rapidly from 2018 when we were fewer than 20 employees to now over 230 employees with a clear focus on continued innovation with research and discovery, as well as expertise in clinical development and regulatory. With that background and our current $1 billion in cash, we believe we are well positioned to advance our pipeline and are looking to the future as we prepare for a potential launch of repotrectinib with additional growth in our medical affairs and commercial teams. Our current macrocyclic platform was internally developed to design highly potent, small and compact inhibitors that could potentially differentiate by overcoming treatment resistance or increased durability of response in indications where few therapeutic advancements had been made. Since then, multiple recent launches in the ROS1+, TRK, MET, RET and ALK spaces have occurred. Yet we continue to believe in the potential differentiation of our pipeline. Focusing on repotrectinib, we believe it to be a potential best-in-class ROS1+ inhibitor based on the data we previously reported in the ROS1+ positive TKI naïve and TKI pretreated non-small cell lung cancer. In addition, we are encouraged by the early signal seen in enteric positive advanced solid tumor patients and the recent breakthrough therapy designation granted in the TKI pretreated patient population, where there are no currently approved targeted therapies. Moving to our second drug candidate, we believe in the potential of elzovantinib to show differentiation as it continues in development, especially due to the biologic rationale supporting the co-targeting of CSF1R and SRC that has the potential to prolong duration of response. We are focused on finalizing our recommended Phase II dose and studying elzovantinib in a less heavily pretreated patient population, where we can further evaluate its potential. Rounding out the pipeline are two additional drug candidates, TPX-0046 and TPX-0131, continuing Phase I dose finding studies. We look forward to sharing our planned milestones for these programs in the first quarter of next year, along with updates from multiple upcoming interactions with the FDA for both repotrectinib and elzovantinib. Shifting now to recent highlights since our last quarterly call. I'm especially pleased with the progress our dedicated and talented Turning Point team made as we received two regulatory designations from the FDA for repotrectinib, initiated the TRIDENT-2 combination study of repotrectinib and trametinib in KRAS-mutant G12D solid tumors, our sixth clinical study, presenting four data updates across our pipeline, and announced the clinical collaboration with EQRx. In addition, we continue to strengthen our executive team, most recently with the hiring of Adam, who joined us yesterday as Senior Vice President of Investor Relations and Corporate Communications. I am pleased to introduce Adam and welcome him to our team. He brings more than 20 years of experience across both large and small biopharmaceutical companies. And I look forward to many of you working closely with Adam over time. Today I will recap our recent accomplishments and provide more details on our anticipated future regulatory milestones into 2022. Overall, we continue to advance our four clinical stage next generation tyrosine kinase inhibitors that target genetic drivers of cancer and our ongoing discovery work, where our goal is to nominate two development candidates in the second half of 2022, one targeting KRAS G12D and the other targeting PAK, both known to play large roles in aberrant GTPase signaling. We specifically chose these targets due to the strong biologic rationale and potential market opportunities, given the addressable patient populations and the limited number of competitive targeted agents that are approved and in current clinical developments. I will begin with our lead program repotrectinib, our ROS1+ TRK inhibitor. Repotrectinib is currently being studied in our ongoing multi-cohort registrational TRIDENT-1 study in patients with ROS1+ positive advanced non-small cell lung cancer and NTRK+ positive advanced solid tumors. We received our second breakthrough therapy designation granted by the FDA for repotrectinib in early October. BTD was granted for the treatment of patients with advanced solid tumors that have an enteric gene fusion, who have progressed following treatment with one or two prior TRK TKIs with or without prior chemotherapy and have no satisfactory alternative treatments. As a result, we plan on discussing next steps towards registration of repotrectinib in patients with enteric positive TKI pretreated advanced solid tumors at a Type B meeting with the FDA next month. Having now received BTD for both ROS1+ and NTRK patient populations, we are well positioned to continue to have frequent dialogue with the FDA regarding our registration strategy. In October, we presented three critical data updates for repotrectinib, two from the registrational TRIDENT-1 study and one from the Phase I/II CARE study in pediatric and young adult patients. Overall, repotrectinib continued to demonstrate promising clinical activity, including in the TKI pretreated repotrectinib positive non-small cell lung cancer and enteric positive advanced solid tumor settings where there are currently no approved targeted therapies. Looking into 2022, we plan to discuss the blinded independent center review data from all four of the ROS1+ non-small cell lung cancer cohorts of TRIDENT-1 with the FDA at a pre-NDA meeting anticipated in the second quarter of 2022. At this meeting, we plan to discuss available BICR data in at least 50 TKI naïve and 50 TKI pretreated patients with at least six months of follow up for the majority of responders. We plan to report the top line BICR data from these cohorts in the second quarter of 2022. Now, let me shift to some of the advancements we have made as we prepare to be a commercial organization. Since hiring our Chief Commercial Officer, Andy, last July, we've continued to build out our commercial leadership team. This team is continuing engagement with KOLs and high volume prescribers in community and academic settings. In addition, our medical affairs team continues to grow and is engaging thought leaders both in the US and globally. Based on our interactions with oncologists, we have continued to refine our understanding of the opportunity for repotrectinib. The feedback we have received has been consistent across market research, advisory boards, and one-on-one interactions, which is that, compared to the two approved therapies, a higher response rate, increased durability, increased progression free survival, and/or the ability to treat or potentially delay the emergence of resistant mutations could be clinically meaningful in the ROS1+ TKI naïve non-small cell lung cancer setting. As a reminder, we've previously reported a higher response rate than historically reported with our competitors in the ROS1+ TKI naïve setting from our preliminary Phase II datasets, as well as the median duration of response of 23.1 months and median progression free survival of 24.6 months in 11 patients previously reported from the Phase I portion of the TRIDENT-1 study utilizing a blinded independent central review analysis. In the ROS1+ positive TKI pretreated setting, there are limited options for patients outside of cytotoxic chemotherapy or lorlatinib, which is not approved in this setting, and has not demonstrated confirmed responses in patients with a G2032R solvent front mutation. In addition, our interactions with oncologists have highlighted that the ability to overcome resistant mutations would be clinically meaningful in this setting. As we look at the opportunity in enteric positive advanced solid tumor patients, we are encouraged by our preliminary data in this patient population. Based on our data, we believe in repotrectinib's best-in-class potential in the TKI pretreated setting where we recently received breakthrough therapy designation and there are no currently approved targeted therapies. Overall, based on our research and data for repotrectinib, we continue to be excited about its potential in both the ROS1+ and NTRK settings. Next in our pipeline is elzovantinib, TPX-0022, our MET, SRC and CSF1R inhibitor currently being studied in our ongoing Phase I SHIELD-1 study in patients with advanced solid tumors harboring genetic alterations in MET. At the AACR-NCI-EORTC meeting, we were encouraged by the updated preliminary data for elzovantinib that was reported from the Phase I dose finding portion of the study. There are no currently approved targeted therapies in MET amplified non-small cell lung cancer or gastric cancer. And we believe we have multiple opportunities to differentiate elzovantinib, including in the exon 14 skipping non-small cell lung cancer indication and in both MET amplified non-small cell lung cancer and gastric cancer. In the third quarter, we completed an end of Phase I meeting with the FDA focused on next steps for elzovantinib in non-small cell lung cancer. During the meeting, we received guidance on the design of the planned Phase II portion of SHIELD-1 and feedback on our recommended Phase II dose. We proposed a recommended Phase II dose of 40 milligrams daily to 40 milligrams twice daily based on the available data at the time of the meeting. The FDA recommended that we explore an additional intermediate dose level using the QD titration to BID dosing strategy in at least 6 to 10 patients prior to starting the Phase II portion of the study. Patient screening at the intermediate dose level of 60 milligrams daily to 60 milligrams twice daily is ongoing. And we plan to enroll at least 6 to 10 patients at this dose as quickly as possible. We plan to provide data from this dosing cohort to the FDA when available, with the intention of revising the SHIELD-1 study into a potentially registrational Phase I/II design and initiating the Phase II portion in 2022. While we focus on enrolling the intermediate dose level, we are also continuing to enroll patients in the Phase I dose expansion portion of the study at the 40 milligram daily to 40 milligram twice daily titration dose level. In addition, we anticipate feedback on the development path for elzovantinib for the treatment of MET amplified gastric cancer next month. Last, as it relates to elzovantinib, we were excited to announce a clinical collaboration with EQRx to evaluate elzovantinib in combination with EQRx's EGFR inhibitor in patients with EGFR mutant, MET-amplified advanced non-small cell lung cancer. We are planning to initiate the SHIELD-2 combination study in mid-2022 pending clearance of the IND by the FDA in the first half of next year. Rounding out our pipeline, our TPX-0046, our RET inhibitor, and TPX-0131, our CNS penetrant ALK inhibitor. We are currently enrolling patients in the Phase I dose finding portion of the SWORD-1 study for 046 and the Phase I dose finding portion of the FORGE-1 study of 0131. Last, turning to discovery, we have four internal programs that target aberrant GTPase signaling known to drive genomically-defined cancers with significant unmet medical need. Our most advanced programs focus on KRAS G12C and PAK, where we are targeting two development candidates in the second half of 2022. Our goal is to submit one IND per year beginning in 2023. We believe these are potentially meaningful opportunities, given the limited number of targeted agents that are approved and in clinical development in these indications. Now, let me turn the call over to Paulo to provide an update on our financial results.

[Paolo Tombesi:]

Thank you, Athena. And welcome to everyone on the call. You will see in our press release and financial tables that operating expenses for the third quarter totaled $67.1 million compared to $43.5 million in the third quarter of 2020. Research and development expenses were $48.9 million in the quarter compared to $32.2 million last year. The $16.7 million increase was primarily driven by the year-over-year increase in investment to develop repotrectinib, elzovantinib, TPX-0046, TPX-0131 and discovery efforts and personnel expenses. General and administrative expenses were $18.2 million compared to $11.3 million in the third quarter of 2020. This increase was primarily due to higher personnel expenses from an increase in accounts and professional fees, including those associated with launch readiness. We expect expenses to continue to run as our clinical and discovery programs progress and as we make additional investment to prepare for the potential launch of repotrectinib. Net cash used during the first nine months of 2021 totaled $86.5 million. Cash, cash equivalents and marketable securities at September 30 totaled approximately $1 billion. We continue to project our cash position fund current operations into 2024. Now let me turn the call back to Athena.

[Athena Countouriotis:]

Thank you, Paolo. To close, I will summarize the expected timing of our anticipated regulatory interactions and the associated milestones for repotrectinib and elzovantinib. First, for repotrectinib, we look forward to our planned Type B meeting next month with the FDA to discuss next steps towards registration of repotrectinib in patients with enteric positive, TKI pretreated advanced solid tumors. In addition, we anticipate reporting top line blinded independent central review data from all of the ROS1+ positive non-=small cell lung cancer cohorts from TRIDENT-1 and discussing the BICR data with the FDA at a pre-NDA meeting in the second quarter of 2022. Next for elzovantinib, we anticipate FDA feedback on the development path in MET-amplified gastric cancer next month. We also anticipate initiating the SHIELD-2 combination study of elzovantinib with EQRx's EGFR inhibitor in mid-2022, pending clearance of the IND by the FDA in the first half of next year. Last, we look forward to continuing progress across our pipeline and discovery work and to outlining plans for our program updates next year. With that, we are now ready to take your questions. Operator, you may now open the line for questions.

[Operator:]

. Our first question comes from the line of Paul Choi from Goldman Sachs.

[Paul Choi:]

A couple for us. Athena, maybe starting with elzovantinib, can you maybe just first update us on how quickly you think you'll be able to enroll those 6 to 10 additional patients for the 40 mg dose titration plan? And then secondly, continue on elzovantinib, do you expect to be able to present additional data from the Phase I expansion portion of the SHIELD-1 study in the front half of next year? Then I had a follow up question.

[Athena Countouriotis:]

First, let me just start by saying that the Phase I enrollment from 60 mg to 60 mg BID, which is the intermediate dose level, has started screening patients. And we look forward to enrolling as quickly as we can. I can't give you more in terms of when we will have the number of 6 to 10 patients, but I'm encouraged with what I've seen so far from conversations with Mohammad. I think equally what Mohammad has done, which is very smart, with our team is to continue to enroll in the less heavily pretreated patients and dose expansion of the Phase I alternative, which is 40 milligrams to 40 milligrams BID. So I do think we'll have a robust data set to show to the FDA. Now that said, I can't project whether we'll have data to show publicly prior to that FDA meeting, but we'll be in a better position to guide to that once we've completed enrollment.

[Paul Choi:]

Maybe as a follow up, I think one of the investor questions post the triple meeting was just thinking about the response rates in the lung patients and I want to just ask you how you're thinking about perhaps expansion into the lung patient population and just thinking about, like, the exon 14 patients in particular and just maybe exploring that more in depth to get greater clarity on the potential signal there.

[Athena Countouriotis:]

One of the things coming out of the triple meeting is, one, we were encouraged by the data, remembering that this was still a Phase I dose finding updates. That said, again, it was all comers, still heavily pretreated. We had one patient who had responded out of the five. But this is a patient that's been treated at MD Anderson now for almost two years. And I was pleased when Dr. Hong on the call mentioned that comment because, again, one of the strengths I believe in this drug is its ability to increase durability of response. Now, that said, if you look at the total five number of patients that we had in that population, three, we had three or higher prior lines of therapy. So again, it's not truly an apples to apples. And yet I appreciate everyone is comparing a 20% response rate essentially to what is in an approved label post one chemotherapy, which is post platinum with Tabrecta with, I would say, a mid-40% response rate. I do not think that is the appropriate comp. I've consistently said that. I do think comparing to a Phase I dataset is the right comp and remembering that capmatinib treated approximately 40 patients, all comers, and had no responses. So, when we look forward to the next steps, again, of course, the focus here is to get through the intermediate dose level as quickly as we can. But we really look forward to studying this drug in a less heavily pretreated population, which Mohammad is already doing in the 40 mg to 40 mg BID cohort now in dose expansion.

[Operator:]

Our next question comes from the line of Michael Schmidt of Guggenheim.

[Michael Schmidt:]

I had two. The first one is on repotrectinib. If you could just clarify again with us regarding the upcoming FDA meeting in the second quarter next year, what are the key points are that you plan to discussing there and what potential outcomes could be? And then I had a follow up.

[Athena Countouriotis:]

One of the things we wanted to highlight today is that our intention is to have the FDA meeting in the second quarter and to provide the data in the second quarter. I do believe that some thought after the triple meeting update that the data may not come until later. And so, we wanted to clarify that today. So, our current plan is to bring the top line blinded independent center review data, of which we've not done that analysis, at least 50 patients who are TKI naïve and 50 patients who are TKI pretreated, and that's based on the most recent updates we just showed in the TKI pretreated populations, with at least six months of follow up for the majority of responders in Q2. That's our base plan. We would normally provide the data after FDA formal minutes, but we are evaluating currently whether we could do that differently and whether we could submit it, especially the top line data to a medical conference. And so, we'll be in a better position to provide more details there as we approach the timeline of the event next year. Now as it relates to the outcomes of the meeting. As we've always said, the key, in my opinion, is whether the FDA agrees with – based on the totality of the dataset, whether six months of follow up will be sufficient, given that this is a pre-NDA meeting to support an NDA timeline. And that's really the key question that comes out of that meeting, whether it will be six months or it will be reverted to our original base case, which was 12 months. And just reminding that rozlytrek has to come in with 12 months of follow up for all responders. So, we are trying to beat that based on the fact that we received breakthrough therapy designation, and they did not.

[Michael Schmidt:]

Just a question on rozlytrek, I think we talked about this before, the fact that the full data, which was generated later, had a lower response rate than what's reflected in the FDA label in ROS1+ patients. And I was just wondering if you had any additional insight as to potential updates to your competitive drug label at some point?

[Athena Countouriotis:]

One of the things I think, again, as I highlighted in my prepared remarks, I do believe this company differentiates on is the strength within our clinical development and regulatory teams. And of course, that's led by Mohammad. We were watching very closely, not only the approval of rozlytrek, but as I've said, for many months, for individuals to look at actually the approval letter, not just the package insert, because the approval letter showed that there was commitments to bring more data. And then, of course, we saw that data updated last year at ESMO. Where, to the point you're making, the rozlytrek response rates became essentially the same as crizotinib at 67%, the duration of response of 15.7 months, and the progression free survival of 15.7 months, which is inferior to crizotinib. I do think that is one of the reasons that this drug has performed poorly in the marketplace. Now whether the FDA will take all of that data – we know the FDA won't put in progression free survival into most single arm studies into a package insert. But I do anticipate at some point the response rate will be updated based on that was a request from them. I just can't predict when the timing of that will occur.

[Operator:]

Our next question comes from the line of Matt Biegler of Oppenheimer.

[Matt Biegler:]

I think you actually just alluded to this in your last remark, but I'm wondering kind of to what extent we can use rozlytrek's launch as a guide for market opportunity, right? So it got approved late in 2019. And I think we should get full-year sales 2020. Kind of what do you think about that launch as a guide for where we're going?

[Athena Countouriotis:]

Well, for all the investors that are on this call, and I did want to highlight what this company has done in the last three years, they met me, obviously, at the end of 2018 when this company was going public. And at that point, rozlytrek was not approved for the timeline you just mentioned. And I said right there and testing the waters, please don't use that as a benchmark for us. Because I believe, with our team, that that was not going to perform well in the marketplace. And that was simply because we were already seeing – it was obvious at World Lung of 2018 that their data set was deteriorating. And so, nothing really has changed, Matt, in my perspective about rozlytrek in the last three years. Unfortunately, for the last two years since its launch, it has performed poorly. And I do think it's, to some extent, those numbers I just gave. I think people are misquoting thinking that rozlytrek progression free survival is better than Xalkori. It's actually worse. And so, what is the place for that drug? And again, I think that we have a differentiated asset. I think that that has been shown based on our breakthrough therapy designation that they did not receive, and the consistent updates that we've shown. Now, remembering that, at this point, we've yet to do our blinded independent central review analysis, but really nothing has changed in my mind, irrespective of that drug's launch.

[Matt Biegler:]

Maybe just a quick follow-up on this upcoming Type B this quarter. This is new. Right? And I don't want to read too much into it. But do you think it might be possible depending on what the FDA wants for follow up from ROS1+ in that and NTRK filing could actually come before ROS1+? Or are you still thinking of combining them together? Or do you think ROS1+ will come before? Kind of what's your thought there?

[Athena Countouriotis:]

First of all, as you can appreciate, I want to get repotrectinib on the market as quickly as I can. And I think, again, that's one of the strengths of this team is that we've been pursuing every avenue. And so again, our second breakthrough therapy designation enabled this second Type B meeting. This meeting will be very similar, I hope, in the intent of the ROS1+ meeting that we performed earlier this year, which is to get more regulatory guidance. Now, previously, they've already given that six months of follow up was sufficient, as long as we provided a heterogeneous number of tumor types. And so, this meeting allows us to have more conversations with them, show them the robustness not only of the tumor types, but also of the different fusion partners that we have within our dataset, and then really discuss how many patients would be required. Now, remembering again we've not yet done the blinded independent central review analysis here. But of course, we have breakthrough therapy designation. So I can't predict that this would be the first NDA, but we're going to pursue as quickly as we can based on the feedback coming out of this meeting.

[Operator:]

There are no further questions coming in at this time. I'm now turning the call back to Athena Countouriotis. We have a follow-up question, Athena. Would you like to take them? The next question comes from the line of Zegbeh Jallah of ROTH Capital Partners.

[Zegbeh Jallah:]

I just have three quick ones, Athena. The first one is just about your thoughts on the pediatric data relative to the adult data that was presented. And sounds like you're going to be separating the data as opposed to where they combine the pediatric and adult. And so, we just wondered if you had any comments about that.

[Athena Countouriotis:]

I trained in pediatrics, so I'm incredibly encouraged by being able to treat pediatric patients. The pediatric program, of course, we had the oral presentation at SIOP showed, in my belief, again, in a very small patient population, activity not only just in NTRK TKI naïve patients, of which they had a very young child with a glioblastoma who has remained in a complete response after multiple rounds of prior chemotherapy. And again, as a physician, I find that incredibly encouraging. But as it relates to the future for repotrectinib and the NDA, we've not yet committed to dividing the dataset. And in fact, that's something that we'll discuss when we bring the data to the FDA not only just for Type B, but obviously in the future.

[Zegbeh Jallah:]

Glad to hear that you've been doing some market research as it relates to repotrectinib. And I was just wondering, can you comment a little bit more on who exactly was sampled? And then, are there any updates on perhaps broadening of the market size or any new updates on increasing patient identification just because you have more therapies now approved?

[Athena Countouriotis:]

Let me just start with what I tried to say in the prepared remarks also. Since the hiring of Andy, one of the things I think Andy has really done an amazing job is bringing in a very talented team. We've just brought in our head of customer engagement. We previously have already brought in our head in terms of payer reimbursement, as well as marketing. And so, we're trying to fill all the teams now as we prepare for a potential launch. Our initial market research campaign was quite broad. It was not only the US, it was also Europe and Japan, because each of those markets, I think, are very applicable to our future. I can't give any more in terms of changes as relates to the market size or patient identification. But I really do look forward to introducing Andy to you and to everyone on the call in the future.

[Zegbeh Jallah:]

Last one here is about elzovantinib. I know you said that you may or may not present data from the expansion. But I was just wondering how much are you going to be looking at that data to kind of drive some of your decision making not only for the dose, but in terms of efficacy in these early line patients?

[Athena Countouriotis:]

First of all, let me clarify, I hope I didn't say that we wouldn't present it. just don't have prior information at this time to say when. The intention would be to be looking predominantly at the pharmacokinetics as well as the safety. And of course, if there's any encouraging signals of activity to provide to the FDA. I do think, again, one of the things that Mohammad and the team really did a great job at is negotiating with the FDA that we will provide this information through an information amendment and receive feedback within 30 days. So, we will not need a new Type C meeting with the FDA to hopefully advance into Phase II. So that potentially can speed up our timeline. And then I'll have better clarity as to what if we're going to do this in a medical conference, et cetera, when we get closer to 2022.

[Operator:]

Our next question comes from the line of Andrew Berens of SVB Leerink.

[Andrew Berens:]

Sorry if I missed some of this, I was bouncing around between a few things going on simultaneously. Can I just clarify when we will see more of the TKI naïve cohort from the Phase II repo trial? I know you said you would discuss the data in Q2 2022. But is there a chance we might see an update like last year around JP Morgan? And then I have a question on the MET, if you can answer that.

[Athena Countouriotis:]

Currently, our focus is getting the blinded independent central review data. And so, at this point, what we're saying is we plan on providing the data in Q2 that would include not only the TKI naive data, as well as the TKI pretreated all by blinded independent central review.

[Andrew Berens:]

Okay. And then on the MET program, the 40 milligram dose, was the FDA's request driven primarily by a need to see efficacy at that level or was it a safety tolerability concern? And then, I just wanted to also know when we might see some of the early ALK data?

[Athena Countouriotis:]

Let me clarify. It was neither as it relates to 022. It actually was that we had very limited data. And I could pass it to Mohammad, but I believe the numbers are correct. I think we had two lung cancer patients in the dataset that the FDA saw. It was relatively limited. Remember, that was a meeting that we performed at the end of Q3 and the briefing document has to go in quite a bit ahead of time. So, the amount of information we actually had at 40 to 40 BID was quite limited. And so, the conversation really was to explore a new dose not specifically for one of the questions that you said, efficacy and/or safety, but obviously just to get more data set in general. But I think equally, we had confidence in the 40 mg QD to BID dose. And so, that's why we're continuing to enroll it. For the ALK program, what we tried to highlight today was for both ALK and RET and I wasn't asked about combos, but the intention would be for us to give updates in Q1 of next year as it relates to when you should anticipate milestone updates from those programs.

[Operator:]

I am now turning the call back again to Athena Countouriotis. Thank you.

[Athena Countouriotis:]

You made me laugh by saying again. So, apologies that now I'm giggling a little bit. Well, thank you, obviously, everyone for dialing in today. I just want to take a moment. I appreciate that this was a continuing challenging year for many of you. And I really want to thank you for your support of us, our company and close by thanking are great and growing Turning Point team for everything that they're doing for patients and their families and everything you've accomplished through again a challenging year. Have a good evening, everyone, and thank you again for dialing in. Operator, you may close the call.

[Operator:]

Thank you, Athena. This concludes today's conference call. Thank you for participating. You may now disconnect.