Q4 2020 Infinity Pharmaceuticals Inc Earnings Call
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Ladies and gentlemen, thank you for standing by and welcome to the Infinity Pharmaceuticals.
<unk> call to discuss the company's operations and full year 2020 financial results. My name is Victor and I'll be your operating from today's call. At this time all participant lines on a listen only mode. It will be a question answer session to follow please be advised that this call is being recorded at infinity requests.
Now I would like to introduce your host for today's call Jayne Kauffman. Please go ahead.
Thank you Victor and good afternoon, everyone welcome to today's call to discuss our recent business progress and review of our full 'twenty 'twenty financial results on the call with me today are Abilene Perkins, Chief Executive Officer, Larry Bloch, President and Brian Swartz consulting chief position, well open up the call for <unk>.
Q&A following our remarks on.
The press release issued this afternoon details our results and is available on our website at N P Dot com.
Please note that during this call we may make forward looking statements about our future expectations and plans, including clinical development objectives, the therapeutic potential of our product candidates, our strategic plans and strategies and financial projections.
Our actual results may differ materially from what we project today due to a number of important factors, including the considerations described in the risk factors section of our quarterly quarterly report on form 10-Q for the third quarter up 2020 and in other filings we make with the SEC. These.
These forward looking statements represent our views only as of today and we caution you that we may not update them in the future whether as a result of new information future events or otherwise.
Now I would like to turn the call over to Abilene.
Yes.
Thanks, Jayne and thank you to everyone for joining us today.
The past four months have been transformative for I think analysts have an infinity with two presentations of Mario one data at the society for immunotherapy of cancer meeting in November two presentations at the San Antonio breast cancer Symposium in December our front line triple negative breast cancer data from them.
Mario three study in second line and above can be seen in ovarian cancer data. How many are two study conducted by our collaborator ARCUS bias in Biosciences and our most recent presentation last month of Marriott 275 data in second line Urothelium cancer at Astro Day you.
Which together demonstrate the broad potential of the analyst day to approve upon diverse standard of care treatment regimen.
We're thrilled that our foundational work in discovering and developing unique analysts I'm a first in class macrophage week programming therapeutic candidate in solid tumors has now translated through to clinical benefit across our program driven by again, a list is unique and fundamental immune modulating mechanism.
On today's call are withheld from cheap physician, Dr. Brian Schwartz will review, the clinical and translational data from our recent analyst day presentation and discuss discuss net.
Program, but before that I'd like to briefly summarize this encouraging data.
First data from Mario one our phase <unk> study in collaboration with Bristol Myers Squibb evaluating analysts it in combination with Opdivo in patients with advanced solid tumors was presented at 50.
Data from this study reinforces the potential at the analyst day to overcome resistance to checkpoint inhibition in patients with melanoma and squamous cell cancer of the head net.
Had progressed on a checkpoint inhibitor as their immediate prior therapy.
Second data from the T N B C cohort of Mario three our phase two study in collaboration with Roche Genentech and when we were evaluating the combination of a gain alyssa with just 10 for kind of Blackstone as a frontline treatment in patients with T. N B C. What's presented at Pepsi.
The data showed an increase in the overall response rate and disease control rate versus the U S centric and Nebraska thing doublet therapy approved for the treatment of PD L. One high frontline C N B C patients.
Additionally, 100% of patients in this study achieved a reduction in tumor volume irrespective of PDL, one status and there was a 100% response rate in PD Lone high patients.
Third data from our ARCUS collaboration a phase <unk> study evaluating again elicit any novel checkpoint inhibitor free regimen that includes a trim. It on their dual adenosine receptor antagonist adopt so in patients with relapsed refractory triple negative breast cancer and ovarian cancer was also.
Presented on Saturday.
This data showed an increase in response rate with the addition of the analysts it to the novel doublet therapy in both indications.
And finally data from Marriott <unk> 75, a randomized double blind placebo controlled phase two study in collaboration with BMS and which we are evaluating again elicit in combination with Opdivo in patients with advance your theater cancer was presented at <unk> last month.
This data showed improvements in response rate disease control rate and progression free survival, particularly in patients with low levels of PD, one expression, who are known to not respond as well to checkpoint inhibitors.
Across these studies, which include double and Triple combination in first second third and beyond once a therapy across multiple solid tumors. A clear signal is emerging that the addition of a gan alyssa improves upon standard of care regimen diverse treatment settings and.
Sure.
These signs of efficacy are bolstered by our translational data, which show a robust and highly consistent immune modulating activity, providing clear mechanistic rationale for the ability of the analysts have to turn cold tumors hot and activate an immune response.
This resulted in an upregulation of PD L. One that's climbing for checkpoint inhibition and improving responses in patients with some of the greatest unmet need in oncology.
The data has enabled us to begin mapping out a clear path forward with the analysts.
Including a potentially rapid path to approval in advanced <unk> cancer by focusing on the PDL, one low population to address the significant unmet need for these patients.
While the data we have generated suggest that again unless it may provide benefit for both PD one high end tier one locations.
On the pier one locations population in Europe, you have cancer provides a number of distinct advantages.
First there's a tremendous unmet need in PD, one low cancer patients with many checkpoint inhibitors not providing benefit for this population.
Evidenced by the fact that the approvals of Keytruda interest centric and frontline you're theall of cancer are limited to PD, one high patients only.
And even in cases, where checkpoint inhibitors are approved for the entire intent to treat population such as the Opdivo approval in second line Euro theater with cancer retrospective analyses have demonstrated that there's little to no benefit for the PD one location.
And Mary a 275, we see that by adding an analyst day Coop depot, we increased the overall response rate in the PD lone low patients to a level that's equivalent to the response rate seen in the PD Lone high patients with Opdivo monotherapy in Checkmate 275.
We had the similar success in bringing the disease control rate in PD, one location to a level above that what was achieved from PD one high patient from checkmate 275, enabling PD one low patients to see achieved the same level of benefit from immuno oncology therapy as the PD Lone high group.
Furthermore, as a controlled trial, we were able to measure the difference in progression free survival between the monotherapy in Nogales, the combination arm, which showed that PDL, one low patients were 46% less likely to experience disease progression with the addition of a gander listen.
Importantly, given the magnitude of the benefit seen with again illicit and marry the 275 with a hazard ratio of 0.54, it should be possible to demonstrate its benefit in a registration focused trials with a relatively.
Few number of patients for this trial can be smaller faster and less expensive to conduct.
Our goal is to utilize the analyst day to extend the reach of immuno oncology drugs to broader patient populations, including those with low levels of PD. One expression whoever represents the largest patient population and have the greatest unmet need.
From a strategic perspective, while we are initially focusing on the PDL one patient for the reasons I just highlighted the data suggest again Alyssa will also be a benefit more broadly be on the PD lone low patients.
This is because the immune activating mechanism of a Gan alissa.
PDL one expression is increased regardless of whether patients are starting with low or high PD lone levels.
So on the long term the data suggests will ultimately provide broad benefit across patients and tumor types, but we're starting where we believe again all this it can be approved most rapidly and cost effectively and PD lone low patients.
Before I turn the call over to Bryan to provide a recap of the data and our next step across our program I want to highlight that we're really thrilled with these data, which facilitated our recent $92 million public offering that leaves us very well positioned to continue the aggressive execution of our clinical development strategy.
It's also important to note that again unless it is the only macrophage targeted therapeutics in clinical development focus on solid tumors.
And given that we've retained full development and commercial rights for Gander list them and have strong composition of matter patents through 'twenty 34, even prior to any patent term extension.
Our unique wholly owned therapeutic candidate holds incredible promise for patients and value creation potential for shareholders.
We are very grateful for the commitment and dedication of our employees collaborators partners and especially our investigators and patients who have enabled this progress and with that I'll turn the call over to Brian.
Thank you I believe I'd like to start with Mario 275, a randomized placebo controlled phase II study evaluating the efficacy and safety of <unk> combination with Nevada, Mab walk Tivo in second line platinum refractory Io naive patients with advanced <unk>.
The old cancer.
The study was designed to evaluate the benefit of adding in Canada to standard of key new volume Mab by leveraging again or listened to the mechanism of action. The insights of Checkmate 275, the accelerated approval study for new volume Mab in second line Io naive <unk> Ken.
So patients.
Our results presented on ESCO G. You were highly encouraging with a combination of that began a listed with no volume demonstrating improved.
From a response rate disease control rate and progression free survival versus second line standard of care on the volume as monotherapy.
And ethylene described it was really in the PD on one low patients where we saw the greatest benefit on.
On Mario 275 or are of 26% in the PD L. One low patients.
Actually the same as the overall response rate at BMS achieved in the PDL, one high patients with new volume add monotherapy in Checkmate 275.
When looking at disease control rate, we reported 57% in the PD, one low which is just above the D CR rate of 52%, which BMS achieved in the PD on one high patients from the volume of monotherapy in that study.
Together. These results strongly suggest that again on this trip has the potential to raise the level of benefit for which the PDL one potion patients received to the same level of debt.
But from Io therapy is the PD Lone high patients currently receive from standard of key.
Moving on to PFS in Mario 275, the hazard ratio for PFS was 0.5 pool, such that patients receiving the combination treatment of 46% less likely to progress relative to patients on the volume there plus placebo.
An indication of significant patient benefit.
I'd like to emphasize how important the hazard ratios on evaluating immuno oncology treatments first I will remind you that the hazard ratios can only be measured and controlled trials given that hazard ratios measure the differences in time to event endpoints of PFS always.
Between the experimental on the control arm of the study and therefore cannot be evaluated in our single on study.
Furthermore, hazard ratios quantify the difference between two arms of the control study over the entire study period.
This is particularly relevant with immuno oncology drugs, where there has been a consistent demonstration of the past decade debt.
There are claims to be significant long term benefit in a small number of patients which is not reflected in the median PFS or statistics.
The long term benefit is referred to the tale of the curve.
On PFS or always kept on my applaud the Golar research with immuno oncology drugs over the past decade has been to increase the percentage of patients who received this longer term benefit thus raising the tail of the curve. We see this executive fixed in Mario 275, and we should tail of the curve is raised.
Firstly, what one would hope to expect to see in enhancing the activity of a checkpoint inhibitor.
This leading to a compelling 0.5 for hazard ratio.
In contrast, the difference in the median PFS, which failed to capture the long term tail effect between the two arms.
Only by a few weeks.
Based on these results we are in the planning stages for a registration trial and also eliciting regularly input and expect initial feedback by early April this process may well entail additional rounds of regulatory feedback, but we inspect expect debt by the end of Q2 2021 we.
We'll be in a position to present the proposed trial design along with more information about the program.
We will of course leverage all the strong findings coming out of volume 275, and we will focus on PD L. One low patients.
The two milligram dose and the time <unk> been customary for a regulatory approval.
Also since our last quarterly call, we presented data from Mario three the triple negative breast cancer cohort at San Antonio breast cancer Symposium.
Mario 275, Mario three study is adding again alyssa to an approved regimen in this case the Roche Genentech regimen after centric in a Brexit in frontline T NBC, which is approved for use only in PD one positive patients.
Triple negative breast cancer is another example of where the benefit of checkpoint inhibitors is limited to the PDL one hi.
Such as approval for both to centric NK truda, the frontline <unk> setting.
Given that again Elisa mechanism of action, which leads to an upregulation of PD L. One and the early data from Mario three. The addition of again Alyssa to current standard of care regimens may enable the expansion to benefit the PD, one low patient population as well.
To assist the <unk> contribution over to Centrica, Nebraska same memorial three trial was designed with high fidelity to the Roche Genentech Impassion 130 approval study with respect to inclusion and exclusion criteria and endpoints to provide a clear benchmark for comparison.
At the best Cancer Conference, we presented efficacy data from the first sales team evaluable patients and head on additional seven patients enrolled at that time, who were included in the safety dataset, but who had not received their first scans.
We're extremely encouraged to report debt of the 13 patients 100% of patients had a reduction in tumor volume and 69% had either a partial response or a complete response with 100% of the PDL, one high patients responding and 50% of the PD lone low patients responding.
We are very pleased that this study is progressing well and in the first half of this year. We will provide an update that will include approximately twice as many evaluable patients from the efficacy perspective. In addition to a more mature data set including a first look of durability from the first 13 patients with.
Presented at <unk> last year.
So in terms of what mixed foot can be see we see three potential wins and path for approval. The most immediate opportunity is in the PD Lone low group with checkpoint inhibitors have not yet been approved including to centric into Brexit combination, which is not approved in this patient population.
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And given that this regimen is not approved in the PD lone low population and an approval trial with again, a lesser one we expect to be going up against the <unk> monotherapy, which is currently the standard of key which weigh in or are in the range of 40 to 50% to 45% is expected.
Importantly, these responses on the Brexit monotherapy have not been durable. So we are looking for both response rates and potential to improve the durability of responses three or four scans or six or eight months, which would be a clear one in this setting.
Mario three data also suggests that we have the opportunity to improve on the benefit obtained from disinfecting of Brexit and the PD L. One high patients as well in that setting we think an hour of about 70% would be meaningful improvement above the.
50, not 58, 9% for the Impassion 150 paired with an improved PFS in the range of nine to 10 months as compared to seven months in the Impassion 130 study this would be a big win in the PD Lone High group.
I think it is also important to remember that we see broad potential freak endless soup to improve upon regimens in TMT see beyond the frontline setting and specific to centric and the Brexit doublet.
The Oct two data presented by our collaborator ARCUS at the same conference, which compared the doublet of <unk> plus <unk> to the triplet <unk> plus <unk> plus stock so demonstrated that day.
That exact potential.
Oh, two evaluated both ovarian and advanced triple negative breast cancer patients in both settings.
The addition of began elissa to the doublet demonstrated a clear benefit.
In ovarian cancer dose escalation portion of portion.
Patients in the doublet arm had a response rate of 14%, which went up to 75% with the addition of began Elisa with those C. Obviously, the doublets and once you are in the triplet.
In the triple negative breast cancer patients in second line and beyond the response rate was 9% for the doublet and went up to 25% with addition of began Elisa.
We were very pleased with this data that shows the promise of began a list have been improving outcomes in a distal regimens, including a checkpoint free regimen in the second line and above shifting CNBC.
This complements our data in the frontline setting with a checkpoint inhibitor.
This data shows that again Elisa has the potential to be backbone therapy in CNBC in the frontline and to a triplet, which includes a checkpoint inhibitor and chemotherapy and in the in the second line and later lines and a triplet that includes chemotherapy, but not a checkpoint inhibitor.
And as mentioned earlier, our frontline data with a checkpoint inhibitor and chemo has the potential to be differentiated with better activity in PD lone low patients pointing to a broad opportunity for egg analyst to improve upon emerging regimens in triple negative breast cancer in multiple.
Combinations in lines of therapy.
Moving to the renal cell cohort in Mario three as a reminder, in this cohort we are combining to centric into Brexit will seek analysts had been the frontline renal cell in frontline renal cell carcinoma, we have completed enrollment with 30 patients in this cohort and expect to report data in the <unk>.
First on <unk>.
First half of 2022.
In contrast to triple negative breast cancer cohorts of Mario three we are adding again elissa to an approved doublet in renal cell cohort, we are adding again alyssa to a doublet, which is not approved and that is more proof of concept study.
To provide some concept.
Context is a lot of excitement around the potential of combining checkpoint inhibitors and VEGF antibodies. So we are adding again elissa to this top of regimen to test the hypothesis on weather.
Again, Melissa can improve outcomes above what we are seeing with the century kind of divesting if.
If we now move forward with the registration study will be evaluating that data from Mario three proof of concept study along with data from recent frontline trials to determine the best approved checkpoint in EBITDA and VEGF combination.
Combined with again Elisa moving forward.
Finally, touching on Mario one.
Let's see we presented data showing or of greater than 20% and a disease control equal to 40% in melanoma and squamous cell patients who have progressed on a checkpoint inhibitor as the immediate post therapy after having received two or less prior therapies.
Moving forward, we see multiple opportunities to leverage this data.
First.
We're interested in further delineating the mechanism in head and neck cancer with a window of opportunity study with our investigator Israel Cohen, who presented the Mario one hit a net cancer data as an oral presentation.
In this window of opportunity study again, Elisa is administered prior to a surgical resection of the tumor.
The changes in the tumor can subsequently be evaluated in the receptor tissue followed treatment from the again Elisa.
Data from this study combined with data presented at <unk>, which showed responses that you get a lesser volume have been patients who have progressed on.
Immediately prior to checkpoint inhibitor therapy will best inform us of the next steps for head and neck cancer.
In terms of melanoma, we are in active discussions with a number of investigators.
To leverage our data from Mario one in melanoma with a doublet therapy, again, Elisa and Pete PD or PD. One blockade. In addition to the triplets, including a PD one inhibitor <unk> four inhibitor from a nature.
The publication with Chad would chalk to understand the potential synergies began elicit PD, one and <unk> four.
We are really excited to see if there is an opportunity to meaningfully increase the efficacy in the PDL, one PD, one or PD, one refractory melanoma subset.
In the past few months, we have revealed a compelling and consistent broad activity profile for Aegon Elisa.
We believe that we have a immediate opportunity for success in the PD lone low metastatic <unk> cancer patients and are looking forward to planning a registration trial in this indication.
And beyond your CTO cancer again illicit activity is seen consistently across the diverse setting indication and regimens demonstrating that additional again alyssa broadly increases patient benefit.
Through its unique immune modulating mechanism.
We are focused on continued execution in Mario three for both the <unk> and RCC and on also evaluating what the data suggests is the ability of <unk> to extend beyond these indications with a focus on PD L. One low patients as well as the potential for <unk>.
Other solid tumors.
The PD one low opportunity is truly best given the majority of patients and the majority of patients with solid tumors have low levels of PD lone expression, making it one of the largest unmet needs in oncology.
We therefore believe that the potential of began Elisa is enormous in terms of addressing the unmet medical needs and as a commercial opportunity and we really focused on delivering on that promise.
Before I turn over the call to Larry I'd, especially like to thank our patients our investigators collaborators at BMS Roche Genentech and off and on because we have continued to Nick dedication. His continued dedication has enabled our progress with <unk>.
I'll now turn the call over to Larry.
Thank you Brian.
Before I turn to our financial results.
I'd like to emphasize what Brian just said in regard to our appreciation for our patients and their clinicians.
Who had been on inspiration and our collaborators have been our truths on partners.
Regards ladder.
The true intellectual foundation for various studies, which stands for macrophage reprogramming immune oncology.
Oh, it was laid out in collaboration.
With our preclinical collaborators, including crutches Triple Chuck from always on Kettering Cancer Center.
And for security harder from UCSD.
Who the lead authors on our two back to back nature articles.
Published in February 2016.
And which delineated the fundamental mechanism of action on.
Selective pharmacological inhibition of <unk> gamma.
And then at the 2000 Seventeens American Association for Cancer Research annual meeting Dr. Jeff could talk.
The children Infinity sensitive.
Advisory Board gave a seminar presentation entitled Reprogramming tumor associated macrophages.
Targeting gets kicked him on to a small molecule approach.
And now where we're truly gratified by the progress that you've made in the course of the last four years since Dr could talk ACR presentation.
I suppose the increasing appreciation for the potential for macrophage targeting therapeutics more broadly.
And we're very pleased that Dr. Judith Varner hesitant.
Has been invited to give a talk at the upcoming ACR annual meeting next month.
It will be a major symposium presentation entitled improving therapy through normalization of the tumor microenvironment.
The presentation release date is Friday April night, and there will also be a moderated 30 minutes.
The session for question and answers on Thursday April 15th at $1 30 to two P M Eastern time.
Now turning to our full year 2020 financial results.
31 2020.
Infinity had total cash cash equivalents and available for sale securities of $34 $1 million compared to $42 $4 million at December 31, 2019.
Importantly, this does not include the approximately $86 million in net proceeds from the public offering that we completed in February of 2021.
Revenue during 2020 was $1 $7 million, which relates to royalties on net sales of peak trough embarrass them.
And secure a bio revenue during 2019 was $3 million, which primarily relates to the achievement of a 2 million dollar milestone from telephone.
Initiation of the first phase III study.
How to get that in.
On Goerlitz syndrome.
Research and development expense for 2020 was $26 $8 million compared to $27 1 million in 2019.
And generally better.
General and administrative expense was $12 4 million for 2020.
Compared to $14 $3 billion for 2019.
The decrease interest expense for 2020 compared to 2019 was primarily due to a decrease of $800000 in compensation primarily related to reduction in stock compensation as well as decrease of half a million dollars on professional services.
Net loss for 2020 was $40 $5 million or basic and diluted loss per common share 68 cents.
Compared to a net loss of $47 1 million or basic and diluted loss.
For common share of <unk> <unk> for 2019.
Decrease in net loss was mostly driven by a decrease in royalty expense for 2020.
In 2019 to Kitty consented to the sale of the Duvelisib cocuzza royalties to help to royalty partners.
HCR and agreed to forgo its rights to an equal share of the royalties due from secure bio exchange, we pay Takeda $6 $7 million, representing 25% of the net proceeds from this royalty monetization.
We then recognized as royalty expense in 2019.
If the <unk> 2021 financial guidance.
On the closing of the $92 million gross proceeds public offering in Sydney's common stock early this quarter is as follows.
Net loss for 2021 to range from between $40 million to $50 million.
And in terms of cash investments.
In 2021 with a year end cash cash equivalents.
On the build for sale securities balance ranging between 70 million and $80 million.
So based on our current operating plans, if any expects that its existing cash cash equivalents and.
Even though sales securities, including the $86 million net proceeds from the public offering we closed on February 2021.
It will be adequate to satisfy the companys capital needs for at least the next 12 months from today.
This guidance does not include the potential for additional funding from Orbitz development activities.
Potential $5 million milestone payment from bvs for positive Ah phase.
Phase III data from the <unk> syndrome.
Three the telephone is conducting or the sale of the company's equity interest in California, or the potential value of these rights to repurchase from DVS. It's telephone royalty interest what is the stock price.
The work of critical $5, a share or at least free days until between now until June 25th 2023 or earlier termination of the agreement.
We appreciate your continued support as we move forward with development at the Analyst day.
At this time, we can open the call for questions operator.
Thank you on your language you ask a question.
Star one on your telephone until withdraw your question press the pound key placed on vital to compile the Q&A roster.
Our first question will come from the line of Nick Abbott from Wells Fargo You may.
We begin.
Hey, good afternoon. Thanks for taking my question and congratulations on on quite interesting set of data Readouts there the last few months.
Just in terms of guidance and they can say you're going to be sufficient for the next day.
What does that entail.
Registration trail change control plus some other exploratory trials.
Yeah.
Thanks, Larry.
Larry I'll take that.
Question. So the guidance. We have currently is based on our current operating plans which includes the.
The initiation of the potential registration, enabling study, obviously that'll be informed by as Brian said, our upcoming interactions with the FDA. So there's some.
Confidence interval around what's the scale and scope on that trial might look like it does not include additional.
Initiations of studies that we might.
Initiate based upon for example, the debt.
Ongoing Mario three <unk> data with funding update score later.
First half this year as well as in the second half this year and we look forward to provide updates on additional <unk>.
Clinical investigations that we might initiate in the balance of this year or thereafter.
Great. Thank you.
Thanks, Dave.
Our next question on sound from the line I know Pam Rama from J P. Morgan.
Again.
Hey, good evening guys. Thanks for taking our question. This is Matt on for on a pump.
So we know that the details on the design of the trial for <unk> in Europe.
Cancer are forthcoming, but we were wondering more on the financial and logistical side, if the clinical collaboration with Bristol from earlier studies.
Including Mario 275 will carry over into the registration focused trials.
And actually if you could remind us of debt terms of the existing agreement that would be super helpful. Thanks, So much.
Sure Matt Thanks for the question so debt.
Existing relationship with BMS on the married to 75 is what we refer to as an arm's length relationship and so on BMS has been extraordinarily supportive in providing opdivo free of charge, which has been important because opdivo is included on both arms of the study given that we're at.
Adding.
Again, it was a two opdivo on the combination arm and comparing it to the treatment arm as well as sharing a lot of insights from their checkmate 275 study.
And being actively involved in the design of our married to 75 study. So it's been it's on a terrific collaboration we have not yet made decisions about partnerships with.
Who and when we'll make partnerships for the registration study. So that's on a to be determined at this point.
Okay. Thank you and I look forward to a sea or in a future update thanks guys great.
And once again Thats star one for questions.
Our next question will come from the line of Ted <unk> from Piper Sandler.
They begin.
Great. Thank you very much congrats on the update on all the progress just trying to get a sense.
You shouldn't that you'll provide more detail following additional conversations with the FDA, but how large do you think.
<unk> III study might be in your cereal cancer things.
So.
I'll start that and Bryan you might elaborate it really does depend on some loans that conversations that we'll have but the reason that we.
We're pursuing right now are focused on the PDL. One locations is because of that strong hazard ratio of <unk> five four which as a result, when we look at our ranges.
For the registration trial, we believe we can achieve on approvable hazard ratio with a relatively small number.
Again, a little pretty mature prior to having those conversations you might target in line and.
And it depends on exactly what endpoints, we use something in the 200 patient range plus or minus 50 patients. So it really does depend on conversations, but that's the ballpark what we're thinking about right now.
That's really helpful looking forward to more deep hearing more details on this study.
Thanks, Chad.
Thank you.
And I'm actually not showing any further questions I'd like to turn the call over to Adam Yan for any closing remarks.
Thank you Victor we're really excited to be advancing this tremendous opportunity for analyst day in PD one patients in your sales cancer and we look forward to sharing additional data from Mario three in frontline T and B C as well as our plans.
More specific plans for the registration trial in the coming months. So thank you all for your continued support and for joining us on today's call and have a nice evening.
Ladies and gentlemen, this concludes the conference call. Thank you for participating you may now disconnect.
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Okay.