Turning Point Therapeutics, Inc.

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 speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Adam Levy. Thank you. Please go ahead.

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 10Q and issued a news release with a summary of our results for the third quarter of 2021. We also updated our investor presentation. You may find these documents posted on the investors' pages of tptherapeutics.com. Leading the call today will be Turning Point's President and Chief Executive Officer, Dr. Athena Kantouriotis, who will provide an overview and update on 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 Dr. Mohamed Hermand, 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 call over to Athena.

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 one 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, Repetrectinib. 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 backbone 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 Repatrectinib 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-TREK, MET, RET, and ALK spaces have occurred. Yet we continue to believe in the potential differentiation of our pipeline. Focusing on Repotrekinib, we believe it to be a potential best-in-class ROS1 inhibitor based on the data we previously reported in the ROS1-positive TKI-naive and TKI-pretreated non-small cell lung cancer. In addition, we are encouraged by the early signal seen in NTRK-positive advanced solid tumor patients and the recent breakthrough therapy designation granted in the TKI-protreated patient population, where there are no currently approved targeted therapies. Moving to our second drug candidate, we believe in the potential of L-zivantanib to show differentiation as it continues in development, especially due to the biologic rationale supporting the co-targeting of CSF1R and SARC. that has the potential to prolong duration of response. We are focused on finalizing our recommended phase two dose and studying L-zivantanib in a less heavily pretreated patient population, where we can further evaluate its potential. Rounding out the pipeline are two additional drug candidates, TPX0046 and TPX0131, continuing phase one 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 Repetrectinib and L-Divantinib. Shifting now to recent highlights since our last quarterly call, I am especially pleased with the progress our dedicated and talented Turning Point team made as we received two regulatory designations from the FDA for Repetrectinib, initiated the Trident II combination study of Repetrectinib and Tremetinib in KRAS mutant G12D solid tumors, our sixth clinical study, presented 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 a barren GTP 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 development. I will begin with our lead program, Repotrectinib, our ROS1 TREC 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. VTD was granted for the treatment of patients with advanced solid tumors that have an NTRK 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 Repetrectinib in patients with NTRK-positive TKI-pretreated advanced solid tumors at a Type V 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 clinical data updates for Repetrectinib, two from the Registrational Trident 1 study, and one from the Phase I-II care study in pediatric and young adult patients. Overall, Repetrekinib continued to demonstrate promising clinical activity, including in the TKI-pretreated ROS1-positive non-small cell lung cancer and NTRK-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-positive 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-naive 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 U.S. and globally. Based on our interactions with oncologists, we have continued to refine our understanding of the opportunity for Repetrecnib. 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 pre-survival, and or the ability to treat or potentially delay the emergence of resistant mutations could be clinically meaningful in the ROS1 positive TK-naive non-small cell lung cancer setting. As a reminder, we've previously reported a higher response rate and historically reported with our competitors in the ROS1-positive TKI-naive setting from our preliminary Phase II datasets, as well as a 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 the 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 NTRK-positive advanced solid tumor patients, We are encouraged by our preliminary data in this patient population. Based on our data, we believe in Repetrectinib'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 Repetrectinib, we continue to be excited about its potential in both the ROS1 and NTRK settings. Next in our pipeline is L-zavantinib, or TTX0022, our MET, STARK, 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 L-zavantinib 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 or gastric cancer, and we believe we have multiple opportunities to differentiate L-divantinib, including in the exon 14 skipping non-small cell lung cancer indication and in both med amplified non-small cell lung cancer and gastric cancer. In the third quarter, we completed an end of phase one meeting with the FDA, focused on next steps for L-divantinib in non-small cell lung cancer. During the meeting, we received guidance on the design of the planned phase two portion of SHIELD1, 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 1-2 design and initiating the Phase 2 portion in 2022. While we focus on enrolling the intermediate dose level, we are also continuing to enroll patients in the phase one 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 L-zavantinib for the treatment of MET-amplified gastric cancer next month. Last, as it relates to L-zavantinib, we were excited to announce a clinical collaboration with ETRX to evaluate L-zavantinib in combination with ETRX's EGFR inhibitor in patients with EGFR mutant met amplified advanced non-small cell lung cancer. We are planning to initiate the SHIELD2 combination study in mid-2022, pending clearance of the IND by the FDA in the first half of next year. Rounding out our pipeline are TPX0046, our RET inhibitor, and TPX0131, our CNS penetrant ALK inhibitor. We are currently enrolling patients in the Phase I dose-finding portion of the SWORD1 study for 046, and the Phase 1 dose-finding portion of the FORGE-1 study of 0131. Last, turning to discovery, we have four internal programs that target aberrant G2PA signaling known to drive genomically defined cancers with significant unmet medical needs. Our most advanced programs focus on KRAS G12V and PAC, 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 Paolo to provide an update on our financial results.

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 dollars, 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 Ribotrecnib, L-dovantinib, TPX0046, TPX0131, 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 account and professional fees, including those associated with launch readiness. We expect expenses to continue to ramp as our clinical and discovery programs progress and as we make additional investments to prepare for the potential launch of reprotecting them. Net cash used during the first nine months of 2021 total $86.5 million. Cash, cash equivalents, and marketable securities at September 30th total approximately $1 billion. We continue to project our cash position funds current operations into 2024. Now let me turn the call back to Athena.

Thank you, Paolo. To close, I will summarize the expected timing of our anticipated regulatory interactions. and the associated milestones for repotrectinib and L-divantinib. 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 NTRK-positive TKIP-treated advanced solid tumors. In addition, we anticipate reporting top-line blind and independent sensory 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 L-zavancinib, we anticipate FDA feedback on the development path in MET-amplified gastric cancer next month. We also anticipate initiating the SHIELD2 combination study of L-zavancinib with ETRX'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.

Certainly. As a reminder, to ask a question, you will need to press star 1 on your telephone. Again, to ask a question, please press star, then the number 1 on your telephone keypad. To withdraw your question, please press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from the line of Paul Choi from Goldman Sachs. Your line is now open.

Thank you, everyone. Good afternoon. Nice to hear all your voices, and a welcome to Adam, and thanks for taking our questions. A couple for us. Athena, maybe starting with Elza Vantanib, can you maybe just first update us on how quickly you think you'll be able to – enroll those six to 10 additional patients for the 40-mig dose titration plan? And then secondly, continuing on Elizabeth, do you expect to be able to present additional data from the phase one expansion portion of the SHIELD1 study in the front half of next year? Then I had a follow-up question.

Hi, Paul. Thank you for the question. So first let me just start by saying that the Phase 1 enrollment from 60 MIGS to 60 MIGS 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 Mohamed. I think equally what Mohamed has done, which is very smart with our team, is to continue to enroll in the less heavily pretreated patients in dose expansion of the Phase 1 enrollment. 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.

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

Yeah, I'm happy to. I mean, I think, you know, 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 one dose finding update That said, again, it was an 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 looked at the total five number of patients that we had in that population, three 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-1 chemotherapy, which is post-platinum with Tabrecta, with, let's 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-1 data set, is the right comp, and remembering that catmatinib treated approximately 40 patients, all comers, and had no responses. So, you know, 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 Mohamed is already doing in the 40 mg to 40 mg BID cohort now in dose expansion.

Okay. Thanks, Athena. I'll jump back in queue.

Okay. Thanks, Paul.

Our next question comes from the line of Michael Schmidt of Guggenheim. Your line is now open.

Hey, thanks for taking my questions, Athena. I had two. The first one is on repotractinib. If you could just clarify again with us regarding the upcoming FEA meeting in the second quarter next year, what are the key points that you plan to discuss in there and what potential outcomes could be? And then I had a follow-up.

Yeah, sure. I mean, 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-naive 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 data set, whether six months of follow-up will be sufficient, given 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 Roslitrac had 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.

And then just a question on Roslitrac, you know, 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. and in ROS1 patients. And I was just wondering if you had any additional insights as to, you know, potential updates to your competitive drugs label at some point.

You know, 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 Mohamed. We were watching very closely not only the approval of Rosletrack, 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 Rositrec response rate 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.

Thanks for the added information.

Our next question comes from the line of Matt Bigler of Oppenheimer. Your line is now open.

Oh, hey, guys. Thanks for the question. Athena, you actually just alluded to this in your last remark, but I'm wondering kind of to what extent we can use Rozletrek's launch as a guide for market opportunity, right? So it got approved late in 2019, and I think we should get, you know, full year sales, you know, 2020. Just, you know, kind of what do you think about that launch as a guide for where we're going?

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, Roswell Trek was not approved to the timeline you just mentioned. And I said right there in 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 that world long of 2018 that their data set was deteriorating. And so nothing really has changed, Matt, in my perspective about Rositrek 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 Rositrek's progression-free survival is better than Zalcori. 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 blind and independent center of view analysis, but really nothing has changed in my mind irrespective of that drug's launch.

Got it. That makes sense. 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, that an 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 thoughts there? Thanks.

Yeah, I mean, first of all, as you can appreciate, I want to get Repetrectinib 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 enables 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 data set, and then really discuss how many patients would be required. Now, remembering, again, we've not yet done the blind and 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.

Got it. Thanks for the question.

Thank you, Matt.

There are no further questions coming in at this time. I'm now turning the call back to Athena Contriotis. Oh, we have a follow-up question. Athena, would you like to take them?

Okay. Sure, of course. Thank you.

Next question comes from the line of Zegbed Jala of Raft Capital Partners. Your line is now open.

Hi. Thanks for taking my question, and apologies for the delay. I just have three quick ones, Athena. The first one is just about your thoughts on the pediatric data issue. relative to the adult data that was presented. And it sounds like you're going to be separating the data as opposed to LOXO, where they combine the pediatric and adult. And so we're just wondering if you had any comments about that.

Thank you for the comments, Zegba. So, you know, 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 PSYOP. showed, in my belief, again, in a very small patient population activity, not only just in NTRK TCAT-naive patients, of which we 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 Repetrectinib and the NDA, we've not yet committed to dividing the data set. And in fact, That's something that we'll discuss when we bring the data to the FDA, not only just at type B, but obviously in the future.

Perfect. Thanks for the clarification. And then I'm glad to hear that you've been doing some market research as it relates to protective. And I was just wondering, can you comment a little bit more on, you know, who exactly was sampled and then are there any updates on perhaps a broadening of the market size or any new updates on increase in patient identification just because you're more you know, therapy is now approved.

Yeah, well, let me just start with what I tried to say in the prepared remarks also. Since the hiring of Andy, I mean, 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, you know, 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 U.S., 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 it 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.

Thanks, Athena. And then the last one here is just about L-divantinib. I know you said that you may or may not present, you know, data from the expansion process, 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?

Yeah, I mean, first of all, let me clarify. I hope I didn't say that we wouldn't present it. I 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 information I do think, again, one of the things that Mohamed and the team really did a great job at is negotiating with the FDA that we will provide this information through an informational 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 two. 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. Okay. and congrats on all the progress, really. Thank you very much, Dagba.

Our next question comes from the line of Andrew Behrens of SVB Lyric. Your line is now open.

Thanks. I appreciate it, Athena. 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-NAIF cohort from the Phase 2 repo trial. I know you said you would discuss the data in Q2 of 22, but is there a chance we might see an update like last year around JP Morgan? And then I have a question on the MED-F. Can you answer that?

Yeah, sure. Thanks, Andy. I mean, currently our focus is getting the Blind and Independent Center Review data. And so at this point what we're saying is we plan on providing the data to in Q2 that would include not only the TKI-naive data, as well as the TKI pre-treated, all by blinded independent center review.

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.

Yeah, sure. So let me clarify. It was neither as it relates to O2-2. It actually was that we had very limited data. And I could pass it to Mohamed, but I believe the numbers were correct. I think we had two lung cancer patients in the data set 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 ALC program, what we tried to highlight today was for both ALC 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.

Okay. Thank you.

Thanks a lot, Andy. I am now turning the call back again to Athena Contar-Yatis. Thank you.

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 is 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 our 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. Operating may now close the call. Thank you Athena.

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