Q2 2021 Turning Point Therapeutics Inc Earnings Call
[music].
Good day, and thank you for standing by and welcome to the turning point Therapeutics second quarter 2021conference call. At this time all participants are in a listen only mode.
For the speakers remarks, there will be a question and answer session to ask the question. During the session you will each of press star 1 on your telephone if you require any further assistance. Please press star zero and I would now like to hand, the conference over to your Speaker today, Jim has all of the head of Investor Relations. Please go ahead.
Okay. Thank you and good afternoon, everyone. Following market close today, we filed our form 10-Q and issued a news release with the summary of our results for the second quarter of 2021. We also updated our Investor presentation. You may find these documents posted on the investor pages of <unk> Therapeutics Dot com, leading the call today will be turning point, president and Chief Executive.
Officer, Dr. Athena <unk>, who will provide an overview and update on our business results before turning the call over to Palo Alto and Basie, Our Chief Financial Officer for a review of our financials. We will take questions. Following our prepared remarks, and we'll be joined by Muhammad Vermont, Our chief of.
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 and turning point therapeutics. Please refer to our recent filings with the Securities and Exchange Commission.
Now, let me turn the call over to Athena and thank you Jim and good afternoon to everyone. Joining us on today's call I am pleased to be joined by Mohamed and our newly hired CFO Paolo who brings tremendous financial experience supporting commercial organizations, which is critical as we advance our current pipeline.
Our growth turning point team of now more than 200 employees has continued to make excellent progress against many important milestones for 2021 since our last quarterly update we have received 2 regulatory designations from the FDA for <unk> zero zero of Q2 and began dosing in our forge 1 study of our fourth clinical.
Candidate, TX and <unk>, bringing our total number of ongoing studies to 5 with 2 additional clinical trial initiation is planned and the second half.
Overall, we continue to advance our for clinical stage <unk>.
And next generation Caris and kinase inhibitors that target genetic drivers of cancer and I look forward to sharing today initial information about our ongoing discovery work and our anticipated timelines to potentially new development candidates.
As always I will start with our lead program. We've attracted net which is a next generation Ross 1 and track PKI with 3 fast track designations for Ross, 1 positive teekay and naive and pretreated non small cell lung cancer patients and and track positive TGI pretreated patients as well as breakthrough therapy.
Nation for patients with Roswell and positive Teekay and naive non small cell lung cancer <unk>.
We've attracted of is currently being studied and our ongoing multi cohort registrational Trident 1 study.
And patients with Roswell and positive advanced non small cell lung cancer, and and trek positive advanced solid tumors as of last week. We now have approximately 300 patients enrolled and the combined phase 1 and 2 portions of the Trident..1 study. This total includes approximately 200 patients in the phase II portion of the study.
And more than 50, and the Ross 1 positive teekay and naive advanced non small cell lung cancer cohort or ESP 1.
We have continued steady enrollment across all 5 additional cohorts within try that 1 and we were pleased to see our partners XI lab dose initial patients in the study in China. This triggered milestones of $5 million, which we recognized in the second quarter.
In June we reached our target enrollment and ESP, 1 and have continued to enroll patients in this cohort based on strong momentum and to provide continued treatment access to new patients.
As we announced last quarter based on feedback from a type b meeting with the FDA.
We plan to discuss the topline blinded independent Central review of results from ESP, 1 with the FDA when responders have been followed for at least 6 months past onset of response, which we continue to anticipate and the first quarter of 2022.
We plan to provide further guidance on the potential registration timeline upon completion of the FDA meeting.
Turning to the second half tried and 1 clinical data update we currently anticipate providing updated efficacy data across multiple <unk> and and trek cohorts by physician assessment and the ACR NCI E. RTC annual conference in early October.
We expect this update at the A&D meeting will also include safety data from approximately 300 patients and at that time, we will be and a better position to provide next steps on other tried and 1 cohorts beyond the XP 1.
Our development plan for <unk> and half includes 2 additional studies beyond try that 1.
The first is our phase <unk> study in pediatric and young adult patients with advanced malignancies, harboring Ross, 1 and track or Alch alterations and we're pleased that our first clinical data has been accepted for oral presentation at the International Society of pediatric Oncology Conference. This October.
The second is our phase 1 be slashed II tried it 2 combination study of <unk> and <unk>, which we plan to initiate in the third quarter.
And the tried and true study will examine safety tolerability pharmacokinetics and any early signals of efficacy of the combination in patients with <unk> mutated advanced solid tumors with the potential to add additional cohorts to the study over time.
Next and our pipeline of <unk> <unk>.
Net stark and CSF Oner inhibitor currently being studied and our ongoing phase 1 shield, 1 study and patients with advanced solid tumors harboring genetic alterations in met.
During the quarter, we received orphan drug designation for <unk> for patients with gastric cancer, including Gastroesophageal Junction Adenocarcinoma. In addition, just last week, we received fast track designation for <unk> for patients with net amplified advanced or metastatic gastric cancer or.
Gastroesophageal junction adenocarcinoma after prior chemotherapy.
As a reminder, there are no currently approved net targeted therapies and gastric cancer. We believe we have multiple opportunities to differentiate <unk>, including and exon 14 indications as well as both net amplified gastric and non small cell lung cancer.
Last fall our preliminary data for <unk> in the first 21 patients treated showed objective responses across several tumor types with a generally well tolerated safety profile and a heavily pretreated patient population.
Since then we have continued enrollment across multiple different dosing cohorts and based on the available PK safety and preliminary efficacy data. We have selected our likely recommended phase 2 dose and began dosing and the phase 1 dose expansion.
This is an important milestone for the program as the patient populations within shield, 1 will now be further refined with less heavily pretreated patients enrolled into the individual cohorts based on tumor type, including exon 14, and net amplified non small cell lung cancer and net amplified gastric cancer.
We are preparing for and end of phase 1 meeting with the FDA this quarter and pending FDA feedback, including agreement on the recommended phase 2 dose. Our goal is to revise the study into a potentially registrational phase <unk> and proceed into the multi cohort phase II portion of the shield 1 study.
Our proposed phase III study design is similar to the phase 1 dose expansion, which is currently ongoing and focuses on 4 main patient populations, including met exon 14, skipping non small cell lung cancer, both treatment nave and pretreated and both net amplified non small cell lung cancer and gastric cancer we plan.
To share more details on the FDA feedback and the phase III design. After the end of phase 1 meeting.
In addition to our tried and 1 data update at the <unk> meeting in Australia.
Providing a clinical data update and patients with met alterations across multiple tumor types from the phase 1 dose finding portion of the shield 1 study.
This update will focus on PK safety and preliminary efficacy data supporting our recommended phase II dose.
Last for <unk>, we continue to anticipate and initiation of our combination study with an egfr targeted therapy later this year.
We plan to provide guidance regarding the details of the study once the IND is filed.
<unk> and our pipeline of <unk> zero for 6 hour Ret inhibitor currently being studied in our ongoing phase 1 to sort of 1 study in patients with advanced solid tumors determined to be ret fusion or mutation positive the.
And the phase 1 dose finding portion of sort 1 continues to enroll patients where we are evaluating multiple doses and schedules to further characterize the pharmacokinetics safety and efficacy profile of before determining the recommended phase II dose.
We will outline plans for our next data update from this program in early 2022.
Last and our pipeline is <unk> 0131, and our CNS penetrant <unk> inhibitor for the phase 1 to 401 study is actively enrolling and we are currently opening additional sites in the U S and Australia. We are excited to advance zero, 1 and 3.1 given the potency we have seen pre clinically which was recently published and molecular.
Solar cancer Therapeutics.
<unk> hundred 1 is a selective alpha inhibitor that is highly potent and a wide array of cellular and in vivo tumor models.
Against the <unk> 96, and compound mutation, which harbors both solvent front and gatekeeper mutations <unk> 0131 had substantially higher cellular activity then approved <unk> targeted therapies.
And in vivo Athena graph tumor studies, <unk> demonstrated complete tumor regression and and Alex dependent model harboring the <unk> solvent front mutation and models harboring compound mutations.
While there are several out inhibitors currently approved we believe zero, 1 and 301 could have great potential initially and TGI pretreated patients, who often develop single or compound <unk> mutations.
Shifting focus now the progress and investments we continue to make and our discovery programs are all directed towards advancing our vision to be the leader and precision oncology.
The company was founded turning point core discovery methodologies has been anchored by deep structure based drug design expertise to deliver highly potent and differentiated small molecules. This approach has enabled us to successfully advance for candidates into clinical development with our lead asset now and and ongoing Registrational study.
Moving forward our goal is a research portfolio that can support at least 1 new IND every year beginning in 2023 today I will share 2 of the for discovery targets. Our team is pursuing and our potential timeline for the future development candidates.
Our focus and selecting new targets begins with the following criteria first addressing areas of high unmet medical need for patients.
And leveraging our deep expertise and fragment and structure based drug design.
Third the strength of the biology of supporting the target and finally, the potential market opportunity.
Each of our for new programs have been established around targets. The play large roles and the Barents GTA for activity and signaling known to drive genomic defined cancers with significant unmet medical need.
Each program is underpinned with a fully enabled structural platform, providing real time protein lag and co crystal structures used to prospectively guide designs we.
We are focused both on and validated targets as well as novel first in class opportunities within oncology.
Today I will share initial information on the 2 most advanced programs the.
The first program targets <unk> mutant <unk> as president and approximately 30% of all cancers and is an attractive therapeutic target for its role in modulating Ras RAF Mec signaling pathways.
And while there is now and approved <unk> T therapy, and Luma crafts there've been very few advances in the 12 day space and it remains an area of high unmet medical need and multiple tumor types, including pancreatic colon and non small cell lung cancers.
Our goal is to nominate a development candidate and the second half of 2022.
Our second program targets, the <unk> 'twenty, 1 activated kinase or the <unk> family. This target represents a multi tumor opportunity with a selective inhibitor of <unk> and Pac for which are key signaling nodes and subset of breast and ovarian cancers melanoma and non small cell lung cancer.
Our goal is to differentiate this program with dual inhibition of amplified pack, 1 and <unk> for which we believe has potential as a single agent and in combination.
We are also targeting and development candidate and the second half of 2022 for this program.
Overall, we are excited by these early pipeline programs and look forward to sharing more detail and future investor and medical forums.
Now, let me turn the call over to Paulo to provide and update on our financial results.
Thank you Athena I'm excited to join the company and look forward for meeting many of you and the coming months, you would see and our press release and financial tables that we generated $5.2 million revenue during the quarter, mainly related to development milestones earned from very low under our licensing agreement for the protection.
Later of China operating expenses for the second quarter, 2 of the $61.8 million compared to $32.7 million and the second quarter of 2002 trends the <unk>.
<unk> $9.1 million increase was driven by $20.5 million, increasing R&D expenses, and $8.6 million and increased and G&A expenses.
Operating expenses for the first half total of $123.1 million compared to $95 for minimum for the first half of 2020.
Excluding a onetime noncash stock based compensation charge and the first quarter of 2020 operating expenses for the first half of 2021 increased by $59.1 million, driven by our increased investment and R&D and growth and G&A expenses.
We continue to expect expenses will increase during the year as we execute the gross melt 5 clinical trial initiated 2 edition of clinical trials and when.
Turning to index.
For the programs.
Net cash used during the first half of 2021 towards the $44.7 million with the revenue we generated from the China of agreements, partially offset the cash used cash cash equivalents and marketable securities of June 30, total of approximately $1.1 billion.
We continue to project our cash position funds current operations into 2020 for now.
Now, let me turn the call back to a cleanup.
Thank you Paulo to close I will summarize our goals for the second half of 2021.
For <unk>, we look forward to providing updated tried at 1 clinical data by physician assessment for multiple Ross, 1 and and truck patient cohorts at the A&D Conference in October. In addition, we plan to report initial clinical data from the ongoing phase <unk> study in pediatric and young adult patients.
At the <unk> Congress in October.
For <unk>, we also plan to provide a clinical data update at the A&D conference in patients with met alterations across multiple tumor types from the phase 1 dose finding portion of the shield 1 study we.
We also plan to initiate the phase II portion of the shield 1 study pending FDA feedback and initiate the phase 1 day flash to shield II study of PBX and <unk> in combination with and Egfr targeted therapy.
And we look forward to continuing progress across our additional clinical trials, including our stored 1 and 401 studies and our planned tried it to study and we will outline plans for our next data update Chinese studies in early 2022.
And lastly, we are excited to continue the ongoing discovery work and look forward to sharing more in 2022, as we get closer to candidate nomination.
With that update we are now ready to take your questions. Operator, you may now open the line for questions.
Thank you at this time I would like to remind everyone in order to ask the question Press Star then the number 1 on your telephone keypads and again that is star then the number 1 on your telephone keypad, we'll pause for just a moment to compile the Q&A roster.
We have our first question coming from the line of Paul Choi with Goldman Sachs. Your line is open.
Hi, Thank you.
And Keira.
On all of the progress.
Couple of questions on shield 1.
First with regard to the the dosing of Gtx zero zero to 2.
You mentioned in your press release that you are and.
<unk> patients and.
The expansion portion of care, but I will skip of ask are you only and.
The rolling patients out of what you. Thank you for the recommended phase II dose or are you still enrolling patients across the.
The different dose levels and.
And schedules here I guess, it's just the measure of your confidence about you find the right dose here.
Yes, let me pass that question said Mohammed Thanks, Paul Thanks, Athena and pipe.
Hi, Paul the Mohammad so thanks for that question.
For the phase 1 expansion portion of the study we are enrolling patients at the current phase II dose as I mentioned, we have an upcoming and the phase 1 meeting with the agency, where we plan to discuss the.
And our recommended phase II dose for them to make sure that the alliance parts of us initiating the phase II portion of the study.
Okay. Thank you for that and then just as a follow up with regards to your upcoming update from the program can you maybe help us think about what the mix of tumor types you might have at the.
The Triple meeting and will you be and are positioned to talk about application of gene amplification of copy numbers.
Procreate, Thank you very much.
Yes, so first of all I can help us following the response as well so the data update in October at the ACR NCI <unk> meeting again in October is going to be from the phase 1 dose finding portion as you may recall.
And.
And all the patients across the number of tumor types Andrea Smith genetic alteration across doses. So that's the data we're going to be presenting at the Athena mentioned the focus of that data as most of you going to be on PK safety and preliminary efficacy of supporting lots of Judy who will try to bring as much data as we can right now so we just recently.
Notified us that acceptance and so right now were.
And the planning stages in terms of putting the pieces together. So we can have the data.
<unk> delivered and time for that presentation.
Got it thank you very much.
Yes.
We have our next question coming from the lines of Michael Schmidt with Guggenheim. Your line is open.
Hey, Thanks for taking my questions and congrats on the updates as well.
And I guess on <unk> 2.
Nice to hear that you're planning to potentially initiate the registration directed phase II cohorts in the store.
<unk>.
Following the FDA meeting I guess, how should we think about the.
Approval bar for those different indications, especially given that.
Message and hybrids are already of the market for exon 40, non small cell lung cancer, but not any of the other counters February enrolling all kind of good.
And in the study.
Yeah, Hi, Michael and thanks, Thanks for the comments as well as the question. So as you know and Youre, referring to of course, the first met inhibitor Thats approved and met exon 14 and patients that have either seen a platinum based chemotherapy regimen or have had no therapy.
As you know, we're exploring and the shield 1 dose expansion right now multiple cohorts happy that we've started dosing and now this is where we refine down the patient populations to have slightly less therapy, then that will be allowed and dose finding but it is very much focused on a few indications, obviously exxon 2014, as well as net amplified.
Lung as well as gastric cancer.
And as we said earlier and we're happy that we received our second designation in terms of the Approvable bar as you know the 1 approved therapy has accelerated approval. So it's not necessarily of benchmark to go against.
But what we think about in terms of ways that we can differentiate clearly there is no approved gastric cancer net amplified targeted therapy, and so we would likely be benchmarked against chemotherapy, but these are the kind of conversations will be looking for it that more feedback with in the context of the end of phase 1 meeting and as Mohamad said he is preparing for that now and that meeting is now.
Planned in the third quarter.
Okay Super and then just a quick follow up on your upcoming update as well on the tried and 1 study I guess, yes, I think you mentioned 2 on the patient's monro and the phase III portion I guess, how are you tracking towards completing enrollment and those cohorts.
And which cohorts will provide data on will that include the.
Of course, 1 as well that the true competing all of it.
You're towards the other.
And the studies.
So the Michael Lohan I, if I can.
A question as well so again, we have been quite pleased with how enrollment has been going and titanfall and we have seen steady enrollment across all of the cohorts.
The thing I mentioned in our opening remarks, we have now enrolled approximately 300 patients in total and the study of about 100 and phase 1 and about 200 and the phase II portion of the study regarding the data updates and October at the <unk>.
The meeting right now of anticipating to report data and again by the physician assessment on multiple Ross, 1 and true cohorts.
With the safety again coming from approximately 300 patients that we have enrolled and try and get 1.
Okay. Thank you so much.
We are of our next question from.
The coming from the line of Matt Biegler with Oppenheimer. Your line is open.
Hey, guys. Thanks for the update and for taking our questions.
And I jumped the gun on the tried and gone update here, but with the 300 patient seems like a pretty substantial increase versus our last call, which was I think at 185.
Should we be expecting of larger focus on and track patients and we add before or.
Just kind of how are you thinking about the breakdown amongst cohorts.
Yes, Hi, Matt and thanks for the question and maybe let me take the second here to say how proud I am of the team. The team has done such an amazing job as it relates to enrollment against what I think has been a very difficult challenging time, obviously with the pandemic continuing with the Trident 1 study and as Ive said consistently we have been enrolling steadily.
Across all of the cohorts, we actually just I believe had our strongest enrollment of cohort and so again I'm incredibly proud of the progress they've been making that said as Mohammad said.
Normally frontline our abstracts and at the same time, it's premature for us to give too much and regards to what youll see but we did say today multiple Ross, 1 and and trek cohorts and it's been awhile since the last update from last August so without going into more specifics I would just say that we look forward to sharing the data and of course, we were just and.
Formed last week.
Got it that makes sense.
And maybe I can just follow up with a quick 1 on.
And the shield 1 trial.
Thought it was really nice to see the activity amongst them that amplified patients and the loss of readout and just kind of wanted your thoughts on how that might portend to the Egfr mutant cohorts at Youre planning to explore.
Or just whether those 2 diseases are too different to extrapolate meaningfully. Thanks.
Yes.
And similar in the sense of you have seen the data that has come and the Egfr setting specifically, obviously with an approved <unk> inhibitor and the combinations and the combination approaches that have been taken with net targeted therapies are.
Our goal is to pursue both our lead asset <unk> as well as our second asset in OTT as both single agents and and combinations and 1 of those combinations. As you highlighted is the Egfr combination that we're planning and I think.
And 1 for the data update that Youll see and the second half while the <unk> and specifics there are more lung cancer patients that will we will hopefully have data for in that update and in addition, we look forward to still initiating the egfr combo prior to the end of the year, we would normally give more information as and India submitted and.
Inevitably excuse me filed and so Thats the plan right now for the Egfr combo.
Thanks Dana.
Thank you Matt.
We have our next question coming from the line of David narrow and darkness with Wedbush Securities. Your line is open.
Hi, Thanks for taking my question just a couple of quick ones.
And you've mentioned a couple of funds physician assessments.
Triple meeting for protecting that and I assume that means.
And we'll be waiting till the extra for the blinded Central review as part of the ongoing day to Clark from there and then.
Another question on repo now the Luma crosses approved I was just curious if you guys were planning and the combo studies with that agent over time or focusing on the.
Other combo that you have up and running.
Yes, hi, David Thanks for the questions.
Specifically said physician assessment, because we didn't want anyone to think that we would have the blinded independent central review of data, which we've not yet seen in time for the A&D presentations. We've consistently said that our goal for the FDA meeting in Q1 of next year is to discuss the data with the agency and then inevitably to come public with the <unk>.
Information that we've had in the context of FDA feedback so thats.
What I can say sorry, as it relates to the the ICR data at this point and in regards to the approval for the first <unk> inhibitor. Yes, we are as I said in the prepared remarks anticipating. The addition of more cohorts into our combination trial I don't know specifically that it'll be luma Kras I have said multiple times some of the cash.
Current capsule burden with the combination based on how many capsules are required for <unk> daily dosing currently is somewhat of a feasibility concern at least for my side right now and so that that trial may start in terms of our 12 C arm into 2022, but we very much look forward to initiating the.
The first arm with <unk> of course this quarter.
Okay. Thank you.
We have our next question coming from the line of Andrew Burns with SBB Leerink. Your line is open.
Thanks, and congrats on the progress of BMO.
Thank you Andy Credit Suisse for sure.
For a couple of on the beverage and strong.
And because of the dosing for 2.2 of a similar dose escalation portion of the minimize the business like repo just wondering if you could give us some color on the.
And then you mentioned the combo with Egfr drugs would that be small molecule of large molecules and are you considering combination of other classes of drugs.
So it could be of a scrape mutation and then laugh.
The fleet.
What's the copy number you've chosen for met amplification.
Yeah sure well first of all and thank you for the comments and also for the questions. Let me take as it relates to <unk>. So we've taken an approach as you filed with the protracted nib and evaluating flat dosing as well as titrations, we did outline in our corporate presentation today, and I've said it consistently that since the culinary.
Session last year for the net program, we have done and additional titration cohorts predominantly focused around 40 milligrams and 80 milligrams, whether you're using QD dosing or the IV dosing and we will wait at this point until we hear the the Fda's feedback on our likely recommended phase II dose to give more information there, but that is essentially why we have been.
Flooring multiple doses as you mentioned in regards to managing safety, which I think is really of much of a follow on to Paul's question in regards to our confidence and our in our dosing approach the.
And the combination for Egfr, we have looked at.
And quite a few potentials and where we are today is again closer to initiation what was the the lens of debt. We don't normally give too much information until an IND has been filed and so I would just say that we've been looking at inclusion of other tyrosine kinase inhibitors, including no approved agents like degrees, though and are using.
Collaborations that could could include antibodies as well and to your escape mutation question and gene copy number at this point, where we are with the program is we're continuing to evaluate both low gene copy number and hygiene combinator asking the hygiene copy number in the ongoing shield trial.
Okay and all of you.
And other programs.
The media for.
Hey, Ross where for the.
And the Great Depression.
Yeah, sorry, I did write it down and I, just didnt address it and my apologies and we were looking at initially based on some preliminary data that we shared at ACR earlier this year at and Io combo, and so I would just say that the lifecycle planning for the OTT program is something that we are currently continuing to evaluate and hopefully we will share more overt.
Time.
Okay. Thank you.
Thanks, a lot of Andy.
So all of our next question coming from the line of Doug <unk> with Roth Capital. Your line is open.
Hi, Thanks for taking my question.
1 last time for question and definitely now.
I think the first is just about expertise and track.
Because we've been so focused on loss of 1 <unk>.
Wondering how you're thinking about that opportunity with the <unk>.
The patients are and you can probably do the same for the pediatric data is long.
I think you said expectations is that right <unk>, sorry, we are and our new building and having issues with the audio of little bit did you say expectation.
Okay and the market opportunity are you thinking.
Okay.
Sure. So let me just start with what we said today in regards to the second half update as Mohammad said, we're excited that we've heard that now we have 3 clinical presentations coming in October and for those that haven't already heard any of that.
The virtual meeting of any unfortunately is still a virtual meeting.
And so at this time, what we're looking forward to is at least a preliminary I believe 5 minutes of video presentation for both tried and 1 as well as shield, 1 and then and oral presentation for our pediatric program now what we said for the Trident 1 update your and track question was that we would give multiple cohorts including.
And Ross, 1 and track so we have committed to and to attract update and in regards to expectations. I've consistently said, we've been pleased with steady enrollment across tried and 1 we always knew that the tried and excuse me that the track naive cohort may lag a little behind the pretreated cohort.
We also have fast track designation for <unk> pretreated patients, but that said with the recent addition of the lab, we've actually been pleased with the way of the enrollment has gone and the track naive population and so my expectations currently that will share more data in the second half as it relates to and track from of.
Commercial perspective, our market opportunity, we have limited information as to how the current approved <unk> inhibitor is doing but I think of course, we're continuing to monitor the clinical landscape in terms of the competition as well as increasing testing rates with more tests, obviously being approved potentially helping that as well.
Thanks.
And can you just comment on the pediatric data as well.
And I apologize Jim was mentioning that to me too I'm, sorry, I Couldnt hear you for that part of the pediatric expectations and now just as a reminder of this trial allows patients and that are either out positive Ross 1 positive of which certain tumor types. Unfortunately are known to be Roswell and driven and in pediatric patients.
And and track and so it is the mix in regards to what to anticipate from that update but again pleased that this is our first clinical update and it was accepted for an oral presentation.
Thanks for the team.
And then just another follow up here, just because I think I heard you mentioned additional cohorts for the <unk> combo and we're just wondering what those cohorts might be and what are you looking for to initiate those cohorts.
Yeah, well at this point, we've been focused initially on the <unk> the combination with traumatic nib as well as <unk> see again as I mentioned potentially in 2022, just simply right now based on pill burden because we've been very pleased with the end of the preclinical data we've shown in the past with AMG 510.
And we haven't disclosed any additional arms in terms of the combination yet so that would have to be more information to come.
Thanks, and and just 2 more here. The first is just regarding the net program wishes wondering ethanol gum to meet with the FDA first before initiating the net comeback, but that is not and then I related.
Forgive me was of Youtube.
And before initiating the combination of Egfr target therapy and Sir.
The segment the Egfr combination our current plan just as we did with <unk> and traumatic nib is to submit an IND. Because this is a combination with <unk> of course, our goal right. Now is focused on the end of phase 1 meeting and are likely recommended phase II dose. We would go right and then into the IND.
Submission to hopefully then disclose more information to you and regards to the IMD being filed so not necessarily of meeting, but it would require and the new IND submission.
Thank you and then the last 1 years, just because we are excited about combos and what that could do for patients and the market opportunity. So I was just wondering as you're thinking about expanding the pipeline you mentioned 2 programs and I was just wondering and important was the potential of <unk> combos with that.
And the discovery programs how important the combination.
And so 1 of the things I would say is just excitement and general of sharing now the progress we've made with the discovery group, yes. Thank you for highlighting the opportunity within the combinations and we did specifically say for at least the P 21 activated kinase or pack the idea of combinations and I believe it was our Linda and our last quarterly call asked me about.
And would we do a combination and the <unk> space with the <unk> inhibitor. So I would just say stay tuned we look for this is just the first a bit of information that we're sharing in regards to our targets but of course now we've put out there that we have hopefully to new development candidates coming and the second half of 2022 with our goal.
Of at least 1 new ind's, starting in 2023 and that May or May not include additional not only just single arm trials and in terms of single agents, but also combination.
Okay.
Thanks, Athena and congrats to join the team on all of the progress.
Thank you so much thanks Douglas.
I always and so pleased with you of coming Unfortunately late in the queue and coming with so many questions. So thank you.
Thank you and again in order to ask the question simply press Star then the number 1 on your telephone keypad.
We are of our next question coming from the line of Silver and Jordan. The JMP Securities. Your line is open.
Thank you for taking my question and congrats on the great quarter and the purpose.
Looking forward to all of the data.
I have a quick question could you please describe.
1 of the hurdles for our Ricardo transforming shield, 1 and 2 of potentially Registrational study that you.
He will discuss with the FDA and he left and then I'll ask 1 follow up please.
Yes, hi field and as mom and I can I can take that 1 so again, we've been quite excited regarding our progress we have made and the ultra 2 program and.
And look forward today.
FDA meeting so of doing that and the pace.
The 1 meeting what we'd like to.
The run by the FDA as the number of items 1 of them is obviously and making sure that align with our recommended phase 2 dose.
Also wanted to talk to them regarding what the phase 2 may look like and 1 thing we would like to do is to basically modify our existing protocol from the phase 1 study into the phase 1 slash 2 study.
Under the same political umbrella, we can actually move into the phase II study is of course 2 of doing a separate trial, which obviously takes additional solar plants and so thats kind of the conceptually how we were trying to approach. It and then obviously once we have the FDA meeting with the minutes in hand.
And I'll come back and share.
Debt.
Great. Thank you so much for the details here and.
About your phase <unk> study congrats on the data presentation of the oral presentation could.
Could you tell us anything about it.
And is fundamentally different and these pediatric tumors that may alter the biology of the response of let's say Ross 1 of the truck targeting or is it more or less the same as in.
The tumors and adults.
Interestingly enough because I train and pediatrics I'll I'll take that for <unk> and the 1 thing I would just say is children and oftentimes and have better tolerability of agents really and it's quite interesting just thinking about less comorbidities et cetera than adults and so 1 of the things we've been very mindful of is dosing.
Within the pediatric population using either a flat dose like we have in the adult program, which is the 160 <unk> going to twice daily or more of a weight based approach, but with the exception of modifying dosing based on weight, obviously, because children get bigger the biology.
The component of what we see is some relatively frequent and.
Unfortunate tumor types that are Ross, 1 driven and then as you can appreciate especially from the prior <unk> inhibitors. Unfortunately, infantile fiber sarcomas are often truck driven as well as glioblastoma and so there are.
To some extent.
Uniti tumor types of you may not have seen in our adult program, which is much more focused at least in Roswell and population of course and lung cancer, but looking forward to the day to update again as I said. This is the first clinical update we'll have from the program.
Great. Thank you so much for taking my questions.
Thanks, very much till then.
Okay. All of our last question coming from the line of Arlinda Lee with Canaccord. Your line is open.
Hi, guys. Thanks for taking my questions and congratulations on the progress.
I had 2.1 can you provide additional color on your earlier pipeline targets on the for.
Philosophy that you have and.
And how youre looking at.
Inhibiting the monarch or these targets are you going to stick with the macrocyclic inhibitor, what's your philosophy on addressing the emergence of resistance versus company trying to.
Target combinations and then secondly can you talk about.
Cash use.
Or what you intend to do with $1.1 billion and cash burn.
Has.
It has been quite low and obviously it will go up as you.
And Chris your combination studies and others, but just curious about how youre thinking about it.
Your cash is tuition and thank you.
Yes, Thank you very much for Linda and I am sorry.
Scientists to spend some time of here later this week as well as your conference. So let me take the pipeline component of <unk> and 1 of the things I think <unk> seen from 1 of your first met with me and we're turning point was obviously still a private company is is hopefully and investment in discovery and specifically from a head count perspective, just further expertise within our chemistry apartment or <unk>.
<unk> Department, our scientific Advisory Board or DM Teekay group and this is now 1 of our largest components of our organization and the philosophy is really 2 ways, which is first to look at validated targets such as what we said today and <unk> and.
And ways of potentially we could develop a best in class assets as we have hopefully with <unk> as well as the rest of our pipeline and then potentially less validated where we could be first in class that might be a little bit more risky, but potentially a larger opportunity and so those are the 2 approaches that the team has been have been taking you know that the macrocyclic platform is the foundation.
Of our current for clinical stage assets of course with re protracted nib and of registration trial and there may be targets, where that scaffold is more appropriate than others and so it's something that we're currently evaluating as we go further as it relates to staying within treatment resistance, there clearly assets within our current clinical stage pipeline.
And that are more focused on treatment resistance and others that are more focused on potentially first line opportunities such as obviously of <unk>, but also even our net program and so I can't say that we're focused in 1 area of resistance vs combinations, but thats, the general philosophy and as I outlined in my prepared remarks.
And sticking to a target product profile the absolutely keeps on net medical need a very clear.
Clear of point of view and our forefront.
In terms of our selection criteria as well as the expertise that we have in house, our biology, and then of course the market opportunities.
And my apologies arlinda and terms of the cash use the <unk>.
Cash use of course at 1.1 billion takes us into 2024 and as it relates to how we plan on using our cash we're going to continue to use our cash as we have been which is continuing to advance our clinical stage assets as well as pushing forward our discovery platform.
Thank you.
Thank you there and no further questions at this time I will now turn the call back over to Dr. Athena <unk> for any closing comments.
Thank you operator, I think that was the best way and operator has ever said my name some of it. Thank you very much for that.
And obviously, thank you for everybody that dialed in today for your interest and of course your support for our company of turning point Therapeutics as I said during the Q&A I'm. So incredibly proud of what the team has accomplished this quarter and I want to close by thanking all of you I know many of you always dial into this call. Thank you for everything that Youre doing every day for us as the company and more importantly.
And for patients and the operator, you may now close the call. Thank you.
This concludes today's conference call. Thank you for participating you may now disconnect.
Goodbye.
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