Q1 2021 Turning Point Therapeutics Inc Earnings Call
Thank you all for standing by and welcome to the turning point Therapeutics first quarter 2021 conference call.
All lines have been placed and listen only mode until the question and answer session of today's conference.
Ask the question over the phone and by that time, you meet press the star key followed by the number one.
I'll now hand, the call over to your host Jim Missoula, Sir you may begin.
Okay. Thank you Jesse and good afternoon, everyone. Following market close today, we filed our form 10-Q issued and 8-K and issued a news release with a summary of our results for the first quarter of 2021, we also updated our investor presentation and you may find these document posted on the investor pages and P. P Therapeutics Dot com.
And our call today will be turning point, President and Chief Executive Officer, Dr. Athena <unk>, who will provide an overview and update of our business results as well as a review of our financials. We will take questions. Following our prepared remarks, and we'll be joined by Doctor and Mohammed Vermont, Our Chief Medical Officer, Mohammed and a separate location for today's call. So please.
Bear with us as we manage your questions across both sites.
And to begin and 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 and turning point therapeutics. Please refer to our recent filings with the Securities and Exchange Commission now let me turn the update over.
Two Athena Thank you, Jim and good afternoon to everyone joining us on today's call.
For anyone new to our story just two years ago, turning point and had approximately 50 employees had just completed our initial public offering and had one clinical stage assets and one ongoing phase one study.
And now two years later, we have approximately 170 employees, we are advancing four clinical stage assets with our lead asset re protracted NAV with five regulatory designations, including breakthrough therapy designation and this year and we plan to start our sixth and seventh clinical study of our drug candidates and.
So proud of the tremendous progress our growing team has continued to make and we work to accomplish the many important milestones we had outlined for 2020 one.
Overall, we continue to advance our four clinical stage next generation tyrosine kinase inhibitors that target genetic drivers of cancer. In addition, we are investing and the discovery engine with a goal and establishing a pipeline for long term growth the progress and investments. We have made are all directed towards advancing our vision to be the leader and precision oncology.
And I will start with our lead program the protracted NAV, which is a next generation Ross one and track T. K I with greater than 90 fold higher preclinical potency than Chris Dot net and greater than 50 fold higher preclinical potency than and trucking it against Wild type Ross one.
We've been tracking it is currently being studied and our ongoing registrational phase II portion of Trident, one and patients with Roth one positive advanced non small cell lung cancer and and truck positive advanced solid tumors.
We recently completed a type b meeting with the FDA based on repo tracked and had been granted breakthrough therapy designation for the treatment of patients with Roth one positive T. K I naive metastatic non small cell lung cancer. The purpose of the meeting was to discuss potential next steps as it relates to clinical and manufacturing and companion diagnostic development.
[noise] attractive with a focus on the PK and naive Ross one positive patient cohort within the Trident one study.
The overall feedback from the meeting was generally supportive based on the FDA feedback we now plan to discuss the topline blinded independent Central review results with the F. D. A one responders had been followed for at least six months past onset of response.
This is new guidance and we believe it can be positive word.
And we plan to provide further guidance on the registration path for the Ross one positive teekay and naive patient population upon completion of the next FDA meeting, which we anticipate having during the first quarter of 2022.
Turning now to enrollment and the Trident one study we continue to enroll across all patient cohorts and anticipate reaching our target of 50 patients with Teekay and naive Rockwell and positive non small cell lung cancer pools, and the phase one and phase two portion of the study this quarter and it remains our goal to provide and enrollment and clinical data updates and the phase III.
And I've tried and one in the second half of the year.
We've been tracking and is also being studied in the phase one two per study in pediatric and young adult patients with advanced solid tumors harboring Alch Ross, one ore and track alterations.
We continue to enroll patients and this trial, which is one of our five ongoing clinical studies. We are now planning to share initial data from this study and the second half of this year.
In addition to our development of Reaper truck and they are in the training and one and a phase one two care study. We are pleased to have within the past month achieved both our third and fourth and clearance within the past two years and as it relates to our first company sponsored combination study and our team continues to make progress towards the planned initiation of the first cut.
Heart of our multi arm tried and two combination study in mid 2021.
His planned phase one day slash two study and K Ras mutant solid tumors is based on read the tracking of the preclinical inhibition of JAK, two dark and Fac, which is believed to suppress that three and a T. T signaling known mechanism of oncogenic resistance and.
At ACR, we showed preclinical data every protracted and combination with approved <unk> inhibitor traumatic net which was more effective and single agent treatment and patient derived K Ras mutant <unk> and V lungs, and day 12 D V and our pancreatic cancer models as we previously announced the first cohort of the tried and true study will examine the safety Tal.
Our ability pharmacokinetics and any early signals of efficacy or read the tracking it and combination with traumatic nib and patients with K Ras mutant G 12 D advanced solid tumors.
Next and our pipeline is P. B ex your zero to two are met Stark and CSF Oner inhibitor currently being studied and our ongoing phase one shield, one study and patients with advanced solid tumors harboring genetic alterations and net net.
And that's driven cancers represent a heterogeneous population across multiple tumor types as was reflected in our early clinical data update last October.
While there are now two approved therapies for met exon 14, skipping non small cell lung cancer. We continue to believe we have the potential to expand the development of O. Two two including that amplified non small cell lung cancer, both as a single agent and and combinations as well as and Gi tumors.
Additionally, we believe there is room for improvement and the Exxon and 14th space given the limited duration of response and safety profile of the two approved agents.
As a reminder, our preliminary data update last year showed objective responses across several tumor types with a generally well tolerated safety profile and a heavily pretreated patient population.
One study continues to enroll patients and we are on track with our goal to identify the recommended phase two dose this quarter. Once elected we plan to proceed directly into the phase one dose expansion in multiple patient cohorts and we anticipate sharing and additional clinical data update from the phase one dose finding portion of shield, one and the second half.
This year.
We have multiple updates anticipated and in the second half of this year for <unk>, including a potential discussion with the FDA regarding our plans to modify the shield one study into a registrational phase one two design initiation of the phase two portion of the study pending FDA feedback and finally initiation of our combination study with an Egfr targa.
And as a therapy.
Next and our pipeline is T P ex euro four six our ret inhibitor currently being studied and our ongoing phase one two sword. One study in patients with advanced solid tumors determined to be ret fusion or mutation positive.
Oh force six is a compact he cai with preclinical potency against wild type ret and multiple ret mutations.
As a reminder, there are currently no approved targeted therapies for patients who have been treated with a prior selective ret T K.
We believe this represents an unmet medical need and opportunity for O four six and in addition to potential safety differentiation.
We recently presented early clinical data for O four six and are encouraged by the emerging profile.
<unk> 0046 was generally well tolerated with preliminary data showing clinical activity and a heavily pretreated patient population.
The phase one dose finding portion of toward one continues to enroll patients and we continue to evaluate multiple doses and schedules to further characterize the pharmacokinetics safety and efficacy profile of a four six before determining the recommended phase two dose we have modified the phase one protocol to include multiple dose expansion cohorts in both Teekay and naive.
And less heavily pretreated teekay pretreated patients.
Next and our pipeline is T. P. Ex Euro 131, our alpha inhibitor currently in the phase one portion of the forge one study in patients with Teekay I could treated all positive non small cell lung cancer.
At ACR, we presented preclinical data demonstrating the potential for O 131 to cross the blood brain barrier. Additionally, we showed O and three one has sub and animal or potency against wild type al and is more potent and comparison to approved alpha inhibitors against many clinically observed resistant mutations.
There are several off inhibitors. Currently approved we believe 0131 could have great potential initially and T. K I per treated patients, who often develop single or compound Alf mutations.
Well Brendan or their lot and it is the current standard of care in this setting.
But given its limited potency against many resistant mutations and its known safety profile. We believe there is an opportunity for a one three once and potentially differentiate based on efficacy and or safety.
Lastly, I want to highlight our growing discovery team. This is a core area of focus for us and as a reminder, and a second half of this year, we plan to outline our research strategy, including our anticipated timeline to new drug candidates, we are making progress and our programs and look forward to sharing more detail later this year.
Now, let me turn to our financial results, you'll see and our press release and financial tables that we generated $25.2 million and revenue during the quarter per Lance primarily related to the upfront payment from XI lab under our licensing agreement for <unk> and greater China opt.
Operating expenses for the first quarter totaled $61.3 million compared to 62.6 million and the first quarter of 2020.
Excluding a onetime noncash stock based compensation charge in the first quarter of 2020 non-GAAP operating expenses increased by $30 million, driven by and $18 5 million increase and R&D expenses, and an $11 5 million increase and G&A expenses.
Increased expenses were attributable to the investments we need to develop our current pipeline as well as in earlier stage discovery and personnel.
We continue to expect expenses will increase during the year as we execute across now five clinical trials initiate two additional new clinical trials and make investments and our discovery efforts.
Net cash used during the quarter totaled $15 $7 million with the revenue we generated from the Zilog agreement, partially offsetting cash used cash.
Cash cash equivalents and marketable securities at March 31 totaled approximately 1.1 billion.
We continue to project our current cash funds current operations into 2024.
To close and I will summarize our goals for the rest of the year beginning this quarter with a key anticipated milestone of reaching our target enrollment of 50 patients with TCR and naive Ross one positive non small cell lung cancer of pools and the phase one and phase two portions of the tried and one study.
Moving onto mid year, we expect to initiate the first cohort of our tried and two combination study and and the second half, we anticipate providing three clinical data updates, including from the ongoing trade and one and shield one studies and initial data from the ongoing phase one two pediatric care study. Additionally, we.
We anticipate providing an enrollment update from the Trident one study initiating the phase II portion of the shield one study pending FDA feedback and initiating the shield two combination study.
Last we also plan on outlining our research strategy, including our anticipated timeline to development candidates.
With that update we are now ready to take your questions before we do I want to close by thanking our great and growing turning point team for all they have accomplished so far this year operator, you may now open the line for questions.
Yeah.
As a reminder, participants you May press the star key followed by the number one to ask a question over the phone.
And it also press the pound key to withdraw your request.
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Our first question is from the line of Michael Schmidt Group.
Hi, and Securities. Your line is now open.
Hey, guys. This is Charles Zhu on for Michael Schmidt and thanks for taking the questions and.
<unk> on the quarter, especially with the feedback from the FDA rigor.
And that meeting and the potential registration paths forward for repo and Ross one of lung cancer and correct me if I'm wrong actually sounds very similar to the old guidance from the early two Rocco transportation, which is great I am wondering over how we should think about.
The potential efficacy benchmark, so given its relative strength recent updates and and what types of scenarios might be FDA request.
Like a 12 month follow up for perhaps a randomized study.
Yeah sure first of all Charles Thanks for the questions and the comment and so let me start with we agree with you and thank you for the congratulations comment we do believe that feedback is positive and that said the feedback was specifically that we should come back and request a meeting to discuss the top line data based on blinded independent Central review as you know.
No we've not unblinded that data yet specifically for the cohort one patient population with a minimum of six months of follow up since the last response now just to your point about previous guidance. This is new guidance going back to our previous guidance to our end of phase one meeting at the end of 2018, the prior guidance from the FDA.
Which was used as the guidance for the Razo truck approval was a minimum of 12 months of follow up to support standard approval. So again. This is new guidance. We are pleased with the feedback but again this will be data dependent for a meeting that were currently anticipating will be and Q1 of next year.
Got it makes sense and very helpful. And it was also kind of wondering if you could help us low level set expectations for the Gtx Inc.
Update later this year or relative to what was presented last year.
The triple and I guess as a related follow up given the diversity of metal for Asian Center potential ranges of copy number and amplification. Just so you can provide some of your thoughts around potentially refining digital population and expansion cohorts going forward. Thanks.
Sure. So as I said during our prepared remarks, we have three clinical trial updates, we will give and the second half of the year Youre alluding to one from the shield one study, which is our net program that studies still remains and the dose finding portion if you remember when we presented and the plenary session last fall we had data at multiple cohorts are $40.
Rams 80 milligrams and 120 100 and can be 120 milligrams and we have subsequently also down additional titration cohorts going from lower doses to higher doses or T. D to B I D. Dosing. So that information is what we're currently collecting and we anticipate that the update and the second half of the year will be coming from this dose finding portion and we don't have a and <unk>.
And it yet on the number of patients and we've not done a dataset cut for this analysis, yet, but that said it will be a heterogeneous population to the point that you made this will still be advanced solid tumor patients with a net alterations and we have not refined down the gene copy number for met amplification yet to your point it is something we.
We may consider and the future as we move into dose expansion, but we havent done that yet during the dose finding portion of it.
Makes sense, thank you and congrats again.
Thank you very much.
Next question please.
Next question is from the line of Paul Choi of Goldman Sachs. Your line is now open.
Hi, Thanks.
And for taking the questions maybe.
Maybe just starting with a follow up on the.
Question have you provided any more or gotten any more clarity on how youre thinking about which egfr combination and you'll you'll focus on and which which tumor types and just as you kick off the phase <unk> portion of of shield to you there just what and how you'll communicate to the market on that.
Yeah, and happy to so we have discussed and it would be focusing within non small cell lung cancer likely the egfr combination partner, though we have not yet discussed and so that could be either and approved agent or utilizing and investigational agent through a collaboration and so that's the additional guidance, we haven't provided but remaining on track to initiate that trial in the second.
Half of the year.
Yeah.
Okay. Thanks for that and then.
Maybe circling back to Detroit, and Wanda and ahead of your plan to FDA discussion early next year, just with regard to.
And I sort of completion.
Telegraphing to the market just the the results from that frontline cohort.
Specific medical meetings that might provide a forum for that and we're just how are you thinking about that thank you very much.
Yeah, I mean, so as I said to Charles a moment ago. We're pleased with the FDA feedback of course, we're remaining on track to complete this cohort this quarter and then per the FDA feedback and addition to where we are with enrollment completion and we're looking at the first quarter of next year for the timing for that meeting it would likely be our standard practice to discuss the results with the.
D. A first and then to submit the dataset to a future medical forum and we have not yet determined which for them that would be though but obviously in 2020 two.
Okay. Thanks, a lot.
Thanks, a lot Paul.
Next question is from the line of Matt Biegler with Oppenheimer. Your line is now open.
Guys. Thanks for the question and congrats on the regulatory update seems like duration of follow up and still somewhat of a wildcard here, but have you gotten any sense from your recent type be about the size of the safety database that the FDA would want to consider for approval.
Yeah, I mean first of all it interesting and that the way the duration of follow up conversation has gone with the agency. Historically if you go back of course, they discuss with US a minimum of 12 months of follow up to support approval and then that was the precedent that was used for razo track. As you know this is a unique asset and the sense that it received breakthrough therapy designation.
And an indication where there are already two approved agents and so with that that led to this type B meeting and we're encouraged by the fact that the agency wants to review the data set with us with less follow ups.
So what I can't say, yet is will that dataset support registration and that of course will be data dependent and we've never looked at the blinded independent Central review data from the phase two but it is encouraging that the agency is willing to discuss with us less follow up than the prior guidance.
And so with that said I mean, that's kind of the first way I would address it from a safety database perspective, we have general benchmarks from Mohamad history of taking drugs to market from my history of taking drugs to market from our ongoing conversations with the agency and the way we built the Trident one study of course supporting safety not only just from the phase two but also the <unk>.
One we believe that will have a sufficient number of patients to support our safety profile now they and specific numbers as to how many patients would be needed that that would be discussed during their review.
That makes sense and maybe I can just follow up with a quick one on labeling and and timelines I appreciate the folks, obviously and Ross, one, but any guidance or or when you might be and are positioned to guide on on when you might be able to discuss like label expansion opportunities for the anthrax tumors.
And so as you know we have two cohorts within the Trident One study now right. So the naive cohort as well as the pretreated cohort. We've already received fast track designation for that track Pretreated cohort. We are now going to share our first data from our ongoing pediatric study that is enrolling <unk> patients.
So there will be more information coming not only just from the Peds study, but also we talked about that we plan on doing a clinical data update in the second half of the year as it relates to the Trident. One study I think to your specific question when will track go into the label. If our first indication is based on Ross' one I can't predict that yet of course that will also be data dependent.
And in discussion with the agency, but clearly we've been having ongoing discussions with the agency because we've already received fast track.
Alright, Thanks, again and congrats guys.
Thanks, a lot and I. Thank you very much for the questions.
Next question is from the line of Zigbee genre of Roth capital partners.
And now open.
Good afternoon, and thanks for the well was nice and analyze deli and I just have a couple of different questions and I think the first Athena is about the type B meeting I can go ahead and didn't you didn't have mentioned, perhaps discussions with the FDA plug and ask with your companion diagnostics and I was just wondering if you had any updates on that and then how would that stack.
And so your timeline.
Yeah. Thank you and it's interesting as I go I, just realized he'd probably have more difficulty with pronunciation of your name and then I do and I, obviously always have issues. So I feel for you there and then.
And back first of all and you go back to the conversations we've had with the agency over the last few years and we had previously disclosed that we submitted for an investigational device exemption with C. D. R. H and that was cleared and that's kind of a standard first step as it relates to companion diagnostic development, we have already identified our partner for companion diagnostic development and weed.
And using our clinical trial assay in the study for prospective testing. So we've been doing quite a bit of work as it relates to the companion diagnostic the discussion with the agency was really just in line with where we are today and what we need to do to support potential labeling and the future and and so that's what I would share as of now but again, we've had ongoing discussion.
With the agency and specifically the PDL age group.
And and then but they're tried and true study I'm just wondering if you're gonna be enriching for specific tumor types and you know are you planning and to pursue some kind of a T shirt and off the table and you're thinking about designing the study.
And the tried and two study and so where we're starting right now is obviously with traumatic nib and G 12 D advanced solid tumors and we've said that this is a multi cohort who are multi arm trial. So there may be other K Ras driven indications are obviously others out.
Side of 12 D. You know, we've already done data with AMG 510, and.
And so whether we would add <unk> 12 C arm in the future is something that we just haven't disclosed yet but for right now the focus is on initiating the trial, we're very happy that the eye and declared and combination so far with traumatic net.
Thanks, and then just the last one here regarding the pediatric care study and they're thinking about on model updates just wanted to know.
Terms of patient identification is it similar to the adult and are there any nuances that we should take into account.
And he did it so the one thing I would say about the pediatric trial remembering that this is still a relatively rare indication, but unfortunately for many children that are diagnosed either with and truck driven tumors out driven tumors or even very rare Ross one fiber sarcomas and we have had a heterogeneous group that has enrolled and.
And so you know we're encouraged to share the first initial data from that study and that's all we're ready to say today, but that will come and the second half of the year.
And as he said that.
And that's again.
Thank you very much.
Next question is from the line of Sobon through Khan of JMP Securities. Your line is now open.
Thank you for taking my questions.
And Brad Thrall progress and M B a type B meeting.
I have a question maybe big picture about your C. Ross and are specific to us.
G 12, the strategy and the free so.
And some preclinical and curious clunky tulsky inhibitors.
How can we.
Think about the data.
And they get and what.
And what could be the strategy going forward with you then maybe switch partnering and propose specific inhibitors or want to always be a met inhibitor and our own uplift or how would that look like.
Thank you first of all for the questions. So long you know at this point given the IMD just cleared and we're looking forward to initiation of the trial and I think it's a little early to say, where we'd be going and the future. If we stay on a doublet stay with them that can hinder or go to a triple a ti regimen, but I will say that our preclinical data that we've shown consistently over the last year and a half.
Multiple medical conferences and supports the rationale based on a sooner just synergistic effect to combine the two agents and so that's where we're going to start the strongest depth of the dataset is engie 12 D and so that is where we're focusing first and then again as we add more arms hopefully to this trial, you'll see where were additionally, going to go with.
The other doublets.
Great. Thank you and.
With respect to the met them MX and <unk>.
<unk>.
There will be a phase two dose reflect understood correctly and in the second quarter, we will communicate that or will we find out.
And you can update and the second half of per year.
We've talked about that I mean, we are we're evaluating obviously knowing that we want to define the dose this quarter. So we're evaluating where we are with pharmacokinetics as well as ongoing safety and this is an area where and Muhammad team is incredibly focused and will likely scenarios, we'll move right into dose expansion cohorts as we've outlined in the prepared remarks and then.
Potentially discuss our recommended phase two dose on our next quarterly call.
Okay.
Great. Thank you so much for taking my questions.
Of course, thank you very much for the question for loans.
Operating and other questions.
Last question is from the line of Arlinda Lee of Canaccord.
Your line is now open.
Hi, guys congrats on the regulatory discussions.
I have a couple of questions one.
On the.
And the trade it and two combination you just announced that and <unk> and cleared for the first combination can you talk about what constitutes and interesting combination for you or additional combinations and how many of these might you undertake.
And what's your first of all thank you or Linda for the comments about the regulatory discussions as it relates to trade and two at this point, we're focused on initiating the trial has turned out and if that's the design and that went to the agency to support our IND clearance future cohorts again, without saying too much as you've seen we've shown data with <unk>.
Inhibitors, so traumatic nib as well as various them six 766 agent and then we've also showed data with AMG 510, we have publicly said that we've also compiled more data with other G 12 T inhibitors.
I will say this is one of the strength of Siegfried and his entire group and has been growing tremendously on the translational front as well as cancer biology front really looking at the science to dictate where we should go and these combinations and so to some extent I would just say how we are going to determine where we go next will absolutely based on the preclinical data and at this point.
Ireland, and Thats, probably I'll say until we start moving the trial towards patient dosing and then adding additional cohorts.
Okay. Thank you.
Thanks for the questions.
And so operator anymore questions.
No further questions.
Okay, well first of all thank you again for everybody who's dialed in today for your interest and support of our team and for turning point therapeutics as a whole I hope you and your families continue to stay well and operator, you may now close the call. Thank you very much.
And that concludes today's conference. Thank.
Thank you all for participating.
You may now disconnect.
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