Q2 2021 Jounce Therapeutics Inc Earnings Call
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Ladies and gentlemen, your conference call scheduled for stock momentarily. Please continue to stand by and thank you for your patience.
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Yeah.
Good morning, ladies and gentlemen, and welcome to the Jones Therapeutics second quarter 2021 earnings Conference call.
At this time, all participants on a listen only mode.
We will conduct a question and answer session and instructions will follow at that time as a reminder, this conference is being recorded at the company's request.
I will now turn the call over to your host Mark your with John's Therapeutics. Please go ahead.
Thank you operator good morning.
And welcome to the Jounce Therapeutics second quarter Conference call.
Morning, We issued a press release, which outlines the topics that we plan to discuss today.
The release is available in the investors on the media section of our website at Www Dot Johns TX Dot com.
Speaking on today's call will be our CEO and president Dr. Rich Murray.
We view our pipeline progress on key milestones followed by our CMO Dr. Beth <unk>.
Well provide an update on our clinical activities our CFO Dr. Peter Shannon will then discuss our discovery efforts and lastly, our CFO Kim Drapkin will review our second quarter financial results. We will then open the call for your questions.
Before we begin I would.
To remind everyone that today's discussion will include statements about our future expectations plans and prospects that constitute forward looking statements for the purposes of the safe Harbor provision under the private Securities Litigation Reform Act of 195.
Actual results may differ materially from those indicated by these forward looking statements as a result of various important factors, including the risk factors discussed in our SEC filings.
In addition, any forward looking statements represent our views only as of today August 6.2021 and should not be relied upon as representing our views as of any subsequent date.
While we may elect to update these forward looking statements at some point in the future, we specifically disclaim any obligation to do so even if our views change.
With that I'll now turn the call over to rich.
Thanks, Mark and good morning, everyone.
John said, a very productive second quarter as we made important progress across all areas of the company.
In parallel with our ongoing pipeline efforts.
No sector as a whole recently seen exciting new advances for PD, 1 or PDL, 1 inhibitors and Io Io combinations.
While this is great news for some patients most of the added benefit primarily occurs and the PD 1 inhibitor naive patients.
Still sorely lacking other desired advances for the PD 1 inhibitor resistant patients.
Our growing and unmet need.
As more and more patients do not respond to the wide and growing adoption of PD, 1 inhibitor therapy as the first Io based treatment.
We believe that our approaches aimed at innate immune system cells such as macrophages.
Potential to address this challenging GAAP effective treatment for PD, 1 inhibitor resistant tumors.
By identifying and inhibiting key checkpoints of the innate immune system.
New populations of T cells can be crime and directed to the tumor.
Something T cell checkpoints alone cannot do.
For patients this might be a recharge and more comprehensive immune response, and 1 that may overcome that significant barrier of treating PD, 1 inhibitor resistance or non responsiveness.
This substantial unmet need is why we consider gtx 80, 60 for our little RB 2 <unk> for Iot for inhibitor to be our highest priority program.
J T X 80, 60 for aims to convert immuno suppressive macrophages to an anti tumor state. Thanks.
You can't create a bridge between the innate and the T cell arm of the immune system.
As a reminder, our phase 1 clinical trial studying gtx 86 before as move quickly through the necessary monotherapy dose escalation portion of the trial.
Beth will share some of that progress with you in a few moments.
More broadly we've made significant progress this quarter across our pipeline.
1 of these accomplishments was the FDA clearance of our force internally generated.
Resulting in our first milestone under the Gilead license agreement of Gtx 18.11.
That $25 million milestone allows us to extend our cash runway through the third quarter of 2023.
Further solidifying the strength of our balance sheet.
With 1 way through this period, we are well positioned to fund our 2 wholly owned POC studies, and Nate and select.
Has there inflection points, while continuing our robust first in class discovery efforts that now include additional targets are below RMB sandwich.
During the quarter, we presented 2 trials in progress or tips posters at <unk>.
It continued to enroll patients and to Nate and select.
Enrollment in both trials is on track.
We also made key employee hires most notably our chief Scientific Officer Dr.
Dr Dmitry theater shot.
Together under Demetrius leadership, we continue to focus on identifying and progressing new mechanisms that target a diverse set of immune cell types in the tumor microenvironment.
We were pleased to be able to share these exciting advancements at our first virtual R&D day in June.
Now turning to select.
Enrollment also continues to progress in our phase 2 randomized proof of concept trial of <unk> in combination with our own PD, 1 inhibitor <unk> in Io naive non small cell lung cancer patients.
The key feature of this study is a rigorous biomarker selection of patients utilizing <unk> growth.
And 18 gene signature that includes genes predictive for both a PD 1 inhibitor response via CD 8 cells.
As well as the unique pharmacodynamic effects of bupa via CD for cells.
We believe this biomarker selection is more stringent than the typical PDL 1 IEC scores.
And we look forward to sharing data in 2022.
Beyond our development programs, we continue to make progress advancing our early stage pipeline.
Our discovery engine and approach has been both productive and value generating and.
And we expect to see more novel programs like Gtx 80, 60 for a J.
<unk> 18, 11 emerge from our efforts.
Looking ahead, we remain committed to achieving the milestones we laid out for the remainder of this year and beyond.
As I mentioned earlier, we achieved our Gtx 18, 11 goal for the year when the FDA cleared our IND.
This <unk> program now referred to as <unk> 18.11.
It is now and Gilead chance and we look forward to following its progress through development.
Looking ahead, we plan to evaluate safety and determined the recommended phase 2 dose for <unk> 864, and opened a tumor specific expansion cohorts in the second half of 2021 now expected in Q3.2021.
Continue enrollment to enable reporting of efficacy and related biomarker data for both growth and city from the select study in 2022.
And continue to advance our discovery pipeline of potential first in class programs with the goal of the new IND every 12 to 18 months.
I'll now turn the call over to Beth to provide a clinical update.
Thanks, Rich and good morning, everyone.
I am pleased to announce this morning that we have completed enrollment in the monotherapy dose escalation portion of the trial and we have selected our target dose for J T X 80.64.
Before getting into more detail on our ongoing proof of concept studies.
Like to emphasize a point rich made about cancer patients in need of better options.
Unfortunately, there are far too many patients still not benefiting from improved T cell based Io therapy with.
With these patients in mind and our goal is bringing the right immunotherapy to the right patients.
We are enthusiastic about the potential for J T X 80, 60 for as a macrophage checkpoint inhibitor to improve clinical outcomes in patients with tumors that are both sensitive and resistant to PD, 1 or <unk> inhibitors.
Both the innate and select trials are key to our belief that novel mechanisms and biomarker strategies are necessary to bring clinical benefit to patients who do not optimally benefit from T cell checkpoint inhibitors.
Turning to have Nate. This study includes dose escalation of both J T X 80, 60 for monotherapy and combination therapy with penny as well as indication specific expansion cohorts for both monotherapy and combination therapy, which are designed to them.
<unk> proof of concept.
This trial was initiated in January 2021, with the monotherapy dose escalation in all comers, meaning no specific indications were pre specified in these patients with relapsed or refractory cancers that had failed all available therapy.
The monotherapy dose escalation cohorts enrolled quickly and we are pleased with the strong enthusiasm from the investigators participating in the study.
In the monotherapy dose escalation, we have completed the evaluation of 7 dose levels across 22 patients.
The target dose was selected based on a combination of safety PK and receptor occupancy data in the first 3 week cycle and will be used in the monotherapy expansion cohort and the first dose escalation cohort with penny.
Efficacy assessments are performed every 9 weeks so with valuation of confirmed response, it's available only after 18 weeks of therapy.
Importantly to date J T X 80, 60 for has been well tolerated with no dose limiting toxicities.
The monotherapy dose escalation included doses from 15 milligrams to the highest plants dose of 1200 milligrams.
We have observed full receptor occupancy throughout the 3 week dosing integral at doses of 300 milligrams and above and we will be moving forward with a dose of 700 milligrams.
Having identified our target dose we are now poised to move into the next stages of the innate study specifically the monotherapy expansion in ovarian cancer and in parallel the combination dose escalation of J T X 80, 64, plus pinney and all.
Comers with relapsed or refractory solid tumors and no therapeutic options.
The combination dose escalation is designed to confirm the safety of the target dose of J T X 80, 64 plus penny.
Leading to the initiation of 7 indications specific combination expansion cohorts.
Combination dose escalation is designed to explore just 2 doses 700 milligrams and 1200 milligrams with for patients per dose level.
Once the 700 milligram combination cohort has been cleared from a safety perspective, we plan to open the indication specific combination expansion cohorts in parallel with the 1200 milligram combination dose escalation cohort.
We remain on track for all 3 of the next stages of the study monotherapy expansion combination dose escalation and combination expansion 2 opened for enrollment in this quarter.
At our R&D day, we shared with you our translational approach to design defining disease areas of interest for J T. X 80, 60 for based on analyses of the tumor microenvironment across tumor types.
We have taken these disease areas of interest and define specific indications to include in the expansion stage of an 8 day.
Just on biology.
Unmet need.
Kerensky Asian from other little RB 2 inhibitors and consideration of PD, 1 or <unk> inhibitor sensitivity and resistance.
We believe it is important to investigate this new and exciting mechanism in 3 different types of patients.
First patients, whose tumors have progressed on or after PD, 1 or L..1 inhibitors and are resistant.
Second patients with tumors for which PD, 1 or <unk> inhibitors are not approved.
And third patients with more typically PD, 1 or <unk> inhibitor responsive tumors for which PD..1 L..1 inhibitors are approved but where there is still much opportunity for improvement.
In the first group PD, 1 or <unk> inhibitor experienced patients whose tumors are resistant.
We will be evaluating J T X 80, 64, plus penny in triple negative breast cancer, non small cell lung cancer, cutaneous squamous cell carcinoma, and clear cell renal cell cancer.
In the second group PD, 1 R. L..1 inhibitor naive patients with tumors that are historically resistant to and therefore have no approved PD, 1 or <unk> 1 inhibitor.
We will be evaluating both J T X 80, 60 for monotherapy and combination with pin me in ovarian cancer and the combination in undifferentiated pleomorphic sarcoma and LIFO sarcoma.
In the third group to assess the potential for J T X 80, 64 in a more PD, 1 or <unk> inhibitor sensitive tumor we will evaluate J T X 80, 64, plus penny in PD L..1 positive frontline head and neck cancer.
Data emerges we will have the opportunity to explore other indications and combinations with J T X 80, 60 for as well.
Importantly, every indication in the expansion cohorts provides the opportunity for us to potentially take to Jounce molecules J T X 80, 64 and Kimi.
Through to registration.
I would now like to turn to an update on BOE per tell them up in our first biomarker patient selection trial select screening.
Screening and enrollment are on track to report data from the select trial in 2022.
As a reminder, we plan to enroll approximately 75 immunotherapy nave second line non small cell lung cancer patients, who will be selected using the predictive pittsfield for biomarker and randomized to vote for plus penny versus <unk> alone.
We believe the tis for for biomarker will select for more appropriate patients for both the C. D. C. D. H mediated benefit of a PD 1 inhibitor as well as the for for the potential C. D for related benefit of book right.
We expected approximately 20% of second line non small cell lung cancer patients to be tis for positive and we are pleased that screening to date has validated this protection.
With that I will now turn the call over to Dmitry to discuss our ongoing discovery efforts dmitry.
Thanks Bill.
As rich said, it's been an exciting quarter and I'm thrilled to now be a fully integrated member of the Jounce team.
At our R&D day in late June I was pleased to share more about the science behind our pipeline translational work and particularly the opportunities around the myeloid cell focus as exemplified by the little RV family.
We hope you found it beneficial to hear from our scientific team directly at this event.
Our scientists and broader research teams steadfast in their commitment to bring novel therapies to patients in need and we're very proud of their work.
In addition to our scientists we were honored to be joined by 1 of our notable founders Dr. Bob Schreiber.
Bob spoke about the scientific rationale for targeting myeloid cell.
And the therapeutic potential of reprogramming macrophages for inhibition of little RB 2 <unk>, which we consider to be a macrophage checkpoint analogous to the PD 1 checkpoint on T cells.
We believe the biology of the little RB 2 pathway highlighted potential to reverse resistance to PD 1 L..1 inhibitors.
We continue to believe that the little or be family represents attractive immuno oncology targets with the potential to improve upon and restore responsiveness to PD, 1 or L..1 inhibitors.
As such we announced at our R&D day that we are rapidly advancing 2 additional little RV family programs through discovery.
1 targeting little or be 1 and the other targeting the lar before.
With our goal of a U I N D. Every 12 to 18 months, we expect at least 1 of our next development candidates with target the little RV family of receptors.
In addition to disclosing these discovery programs during the R&D day, we also focused on the utilization of our translational science platform to.
To address the problem for patients with cancer are facing today.
Namely resistance to T cell checkpoint inhibitor therapy.
We believe that our ability to dissect the tumor microenvironment at the molecular level using immune cell type specific gene signatures will lead us to target, but maybe important for overcoming resistance to checkpoint blockade.
We also use Gtx 80, 60 for as an example to demonstrate our integrated biomarker approach from discovery through development.
We believe this approach is key to the value generating programs we are pursuing.
I will now turn the call over to Kim for a discussion of our second quarter financial results Kim.
Thanks, Dmitry and good morning, everyone.
As we reported in this morning's press release cash cash equivalents and investments as of June 30th 2021 increased to $246.1 million compared to $213.2 million as of December 31st 2020.
This increase was primarily due to the $90.9 million in aggregate net proceeds from sales under our follow on public offering and our ATM offset by operating costs incurred during the period.
June 30, 2021 cash balance excludes the $25 million milestone earned in the second quarter as it was received in July 'twenty 'twenty 1.
Turning to the P&L, we recognized $25.4 million in license revenue during the second quarter of 2021, which was comprised of revenue related to milestone achievement and noncash revenue related to research and transition services performed under our license agreement with Gilead.
No revenue was recognized during the same period in 2020.
During the second quarter of 2021, we incurred $22.1 million in research and development expenses compared to 21 million for the same period in 2020.
The increase in R&D expenses was due to increased expenses for manufacturing activities performed for our development programs and increased clinical and regulatory spend on J T. X 80, 60 for offset by decreased spend on both fronts.
General and administrative expenses were $7.3 million for the second quarter of 2021 compared to $7.2 million for the same period in 2020.
The increase in G&A expenses was primarily the result of increased insurance expense.
Net loss for the second quarter of 2021, with 4 million, resulting in a basic and diluted net loss per share on 8 cents.
As compared to a net loss of 28 million for the same period in 2020, resulting in a basic and diluted net loss per share of 82 cents.
The decrease in net loss and net loss per share was attributable to revenue recognized under the license agreement with Gilead during the second quarter of 'twenty 'twenty 1.
We are reiterating our cash burn guidance and continue to expect gross cash burn on operating expenses and capital expenditures for the full year 2021 to be approximately 95 million to $110 million.
We also have on updating our cash runway guidance in light of the 25 million Gilead milestone earned.
We now expect our existing cash cash equivalents and investments to be sufficient to enable the funding of our operating expenses on capital expenditure requirements through the third quarter of 2023.
Jounce continues to focus on patients first and we are proud of the Io pipeline. We are building to address the growing unmet medical need faced by cancer patients.
Before closing I'd like to take a moment to recognize the efforts our team makes every day and congratulate them on our fourth I N D and the advances we have made across our pipeline.
Look forward to updating you on our programs as the year progresses.
With that we would now like to open the call for your questions operator.
Thank you place on gentlemen asked from minus to ask a question on the phone line. Please press. The Star then the 1 key on your touched on telephone to withdraw your question press the pound key please standby, while we compile the Kenny Alaska.
And our first question coming from the line of pads on Huff with Piper Sandler Your line is open.
Great. Thank you very much from thank you for the update I was wondering if we could definitely be it.
At least on those so early.
For kind of cadence of enrollment.
Initiation of these expansion cohorts, obviously your cash into that broadly here, but are there any of that either make more sense or are kind of a higher priority order greater interest CT. Thank you so much.
Thanks, Ted this is Beth so.
But that's an interesting question, we actually are really excited about all of the expansion cohorts I don't think I would say that any are higher priority than others.
Selected our sites to be able to enroll.
Across all of the expansion cohorts. So you know some are rare tumors than others, such as sarcoma as for cutaneous squamous cell carcinoma, but we've tried to balance the sites to try to hopefully have.
Fairly similar enrollment in all of them. So yeah, there may be a little bit of difference, but we expect it to be pretty minor.
So we'd hope that all of the cohorts could be enrolling in parallel.
Fair enough and I apologize if I missed this but did you disclose what the go forward does force a balance in between a couple of things. Thanks, Yeah, Yes, we did yes, so the target dose, which is both for the monotherapy expansion cohort and also the first combo dose escalation cohort August 700 milligrams every 3.
The weak awesome great.
Great. Thank you very much congrats on product.
Thank you.
Yeah.
Yeah.
And our next question coming from the line on Con cause he with Baird. Your line is open.
Yeah.
Great. Thanks, Good morning, Thanks for taking our questions.
Thanks for the updates today could you provide a little more color on the receptor occupancy you saw at the 700 milligram go forward dose versus what you saw at 300 milligrams. When you started seeing complete except for occupancy and then can you comment specifically on what you saw.
It's actually both in terms of efficacy and safety at the higher doses that you're testing beyond 700 megs.
I'm sure so with respect to receptor occupancy.
Once you Max out.
Hard to go any higher.
So we saw continuous.
Complete receptor occupancy throughout the entire 3 week dosing cycle that.
300 milligrams every 3 weeks and all doses above that so really once you. Once you hit that you cant really go any higher so we just have complete receptor occupancy, which is exactly what you want for an inhibitory molecule since our goal is to prevent little RB 2 from finding for any of its like EMS. So we've achieved.
That at 300 milligrams and all doses above that.
And then on for your other question. So as we reported them its been well tolerated we did not have any dose limiting toxicities with monotherapy.
But we aren't reporting it because she at this time.
And.
Rapidly advancing our molecules targeting little R. D..1 and loom on it before towards development candidate and would be very happy to provide for their updates in the future.
Great. Thanks for taking on <unk>.
My next question coming from the line Boy sticker with Colin Your line is shopping.
Good morning, maybe let me just start with the select trials can you provide some additional color on the timing of it that all day beyond just 20th 22, whether you know first half a second half or any kind of specific medical meetings, where do you think would be reasonable to have for that.
Thanks for the question, so as as enrollment continuous and we get closer than will provide a narrower window for guidance, but for now just 2022.
Got it.
And maybe on 18.11.
I understand that Gilead controls this molecule now.
Is there any timeline or when would you anticipate that kind of an update on natural.
Yeah, Hey for assistance rich I'll take that 1.
Yeah. So you know we've got a very engaged partnership with Gilead. There you know extremely excited about the program and we fully expect them to move that forward as quickly as quickly as possible. So we're pleased with that we don't want to speak to their time minds that would have to be a question has to be a question for them, but it's been extremely productive.
Active in and we think they're raring to go.
Great. Thank you very much for taking my questions.
[noise] No next question coming from the line of D C and help with claiming James Your line is open.
Good morning. Thank so much 700 milligram dose that you selected for.
For you to 64 was between 2 doses in your dose escalation mono therapy portion I'm still a bit unclear on the rationale for that specific dose given the full receptor occupancy down to 300, Migs and no D. L to use up to 1200 major 900, Big So I was hoping you could just comment on what factors were driving that those selection. Thank you.
Sure. Thanks for your question, Steve. So we chose for Joseph 700 milligrams to ensure that all patients would have complete blood receptor occupancy and also to increase the likelihood of for receptor occupancy in the tumor.
So as you know does selection in the phase 1 trial.
It's made based on a small number of patients and and P. K and reset for occupancy can vary between patients.
So in addition to the amount of drugs. It actually gets into the tumor may vary by the type of tumor. So since paychecks 80, 64 has been well tolerated up to 1200 milligrams. She had the luxury of selecting a dose that optimizes receptor occupancy for all patients now to the point that it wasn't 1 of the doses we test.
What we do is we take all of the data and leave plug it into population PK model that helps us to figure out you know where.
We get to that that <unk> part of the curve for reset for occupancy for almost all patients and so 700 milligrams proved to be the the right notes for that.
Very helpful. Thank you.
And that's on my lifetime gentlemen to ask a question please price for 1.
My next question is coming from the line.
<unk> from working with H D. When writes your line or something.
Good morning. This is arcade from his he ran right mm congratulations on all the progress and obviously for.
For entering into some exciting times here.
Mm mm.
In terms of the data the date of the 2 collected so far and the dose escalation phase would you be present thing.
[noise] them.
For any conference this year or is that you know that'd be for some for next year, but it's our additional data from you know the the study said you're starting now.
Sure I know everybody's excited about about the data as her we we're really pleased by the rate of progress given the timing of the data and the abstract submission deadlines, we don't expect to present day that this year as you know our preferences on it as 2 per cent of the medical need.
<unk> and we also wanted 2 per cent of meaningful body of data on include.
[noise] dose escalation and it is sanchez for both mine on 1 combo and also as I mentioned on the call.
We can't really assess efficacy unless we have 18 weeks data should we wanted to wait till we have 18 week data on on all the patients that we per cent. So again, we share your excitement and we really believe this program on this drug has the potential to be paradigm shifting but we're gonna wait until we have a meaningful body.
Data.
Thanks for that but 1 other question on the mono therapy expansion into the ovarian cancer can you remind us what's the rationale there why for Ya.
Sure. So uhm S. You may recall him and as we share Nazi R&D day.
We we had very strong biological rationale for all of the tumor types that we're selecting he started with biomarkers that could be potential predictive biomarkers for the program and then we looked in large datasets for tumors that had high expression are high.
Portion of patients tumors that had expression of those biomarkers. So we start with the biology.
Then look at it through the window of unmet need opportunity for differentiation and and whether tumors or you know in P. D..1 since P. D..1 inhibitor sensitive for resistance. So for mono therapy ovarian really checked all the boxes for a strong biologics rationale it's a P D..1.
Inhibitor naive tumor we thought it was important for mono therapy to be going into P. D..1 inhibitor naive patients since the P. D wanted hit their experienced in resistance patients had been such a challenge.
So you wanted a P D..1 inhibitor naive tumor where P. D..1 is typically don't work that well and we're hoping that a different mechanism of action may also give us you know some benefit there.
And obviously an area of high on that needs Rich did you want to add anything to that.
Yeah sure. Thanks for that Yeah, I think Archie. It's also you know as we think about the science behind the mechanisms.
We want to take advantage of any mono therapy pass that week that we could fine, but if you think about an 8 system checkpoint got it releasing and finding new populations of T cells, you may need that P. D..1 inhibitor on that kind of back in with those needs T. Salt. So we think you know hence the focus on 7 combination.
On studies that will be putting up starting this this this quarter, but we certainly don't want to miss the opportunity for mono therapy and so we we we took what we thought could be the best choice for mono therapy.
Thank you, but thanks switch on but.
And our next question coming from the lineup Jasmine Charlotte with well most capital partners to be on a cell phone.
Good morning, Thanks for taking my question just kind of wanted to follow up on E 60 for which is kind of wondering outlet add a E were quite common you know following treatment around you know somebody that's S fishing, making to go with that goes.
I'm, sorry to say, but can you repeat I didn't quite get the question.
He apologize my if that sounds a little bad for his wondering from the time I H E that were.
You know within that range cause he didn't really <unk> 700, but within that range.
Sure. So we haven't reported on you know the for safety profile. All we're saying at this point is still well tolerated we've had no dose limiting toxicity.
But I think I would say we're fairly comfortable.
In terms of safety to let <unk> with their program.
Things that for him just to follow up a small which is also wondering if the plan is to it for an accelerated approval path for mono therapy as soon as the pieces that are being treated are pretty late.
Sure that's a great questions like that and it as rich mentioned you know for us pursuing mono therapy is really important because as you were alluding to that certainly would be the fastest path to approval since it would be a single arm mono therapy trial.
So that would be wonderful I think we'll wait and see what are the day to take some but that's certainly 1 of our considerations in uhm opening amount of therapy cohort.
Thanks and is the plan to also use the same goes for mono therapy and combo treatment and then a follow up to that is also any expectations as to when we might begin to see responses. I think he said 19 weeks or 18 reset the day. She can of treatment you know how quickly you can.
We might be able to see somebody finds it.
Sure so regarding the dose yeah to the you know we were we're really pleased that we're able to start combo dose escalation as the target those and so basically if that clears safety then we will start the expansion <unk>, which at that target those in combination.
We'll still as I mentioned will do 1 higher dose 1200 milligrams for it will run that in parallel with opening the tumor specific expansion cohorts on then in terms of data as I as I mentioned.
When we present day, though we really want it to be a robust data package with meaningful data on it you know a substantial number of patients. So uhm just given the timing of when will start getting that 18 week data and abstract deadlines. We won't have you don't expect your present day that this year, but we will continue to.
Diet as we see how enrollment those.
Thank you and then the last 1 for me is on that day. So I don't know I'm thinking about this in the past, but it's actually curious as to what you think the hurdle is allowed the response might be for opinion alone in the select study just because you're doing.
Doing a better job for you selecting teachers. So why do you think in the hurdle is to kind of move this fight or what are you thinking.
<unk> get from that pay me alone I'm.
Sure. So the benchmark are available from the data on which Nivo Pembroke on a Tesla listen that were approved in second line P. D..1 inhibitor naive non smoking so lung cancer and those response rates ranged from 14 to 20 per cent. So of course they weren't approved.
Based on response rates. They were approved based on overall survival, which is much more important endpoint well for any drug but also for.
No therapy, since that's where immunotherapy really makes the biggest difference so.
So.
You know something that compares favorably to those would be a good start but remember the primary endpoint of the study is 1 that we believe is a better predictor for overall survival.
And a better reflection of the benefits of Io therapy and that's the.
Tumor reduction average sober 9 and 18 weeks for the per cent change from baseline in the in the tumors. So we'll be looking at that will also be looking at response rates, but again something that compares favorably to Ah 14th to 20 per cent response rate would be a starting point.
Thank you.
[noise] no I'm not showing any further questions at this time.
And ladies and gentlemen that bathroom call conference for today and thank you for your participation you may not disconnect everyone have a great day.
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