Q1 2022 Infinity Pharmaceuticals Inc Earnings Call
[music].
Ladies and gentlemen, thank you for standing by welcome to the Infinity Pharmaceuticals conference call to discuss the company's operations and first quarter blended 92 financial results. My name is Sarah and I'll be your operator for today's call. At this time all participants are in a listen only.
Mode.
There will be a question and answer session. Chicago. Please be advised that this call is being recorded at infinity to glass now I would like to introduce your host for today's call Jayne Kauffman. Please go ahead.
Thank you Sarah and good afternoon, everyone welcome to today's call to discuss our recent business progress and review of our first quarter 2022 financial results and company highlights on the call with me today are Abilene Perkins, Chief Executive Officer, and Chair, Larry Bloch, President and Robert Deloria Junior Chief.
Medical Officer, we will open up the call for Q&A following our remarks.
The press release issued today details our results and is available on our website at <unk> 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 annual report on Form 10-K for 2021 and in other filings, we make with the SEC.
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'd like to turn the call over to Abilene.
Thanks, Jayne and thank you to everyone for joining us today to review Infinity first quarter 2022 progress.
As we discussed on our most recent call just five weeks ago 2022 is an execution year in which we are focused on expanding the clinical evaluation of the analysts in additional solid tumor indications and establishing the best path forward to maximize the value began a listed for patients and shareholders.
We are aggressively advancing the development of again listed including the initiation of our first registration trial Mario for in frontline.
Metastatic triple negative breast cancer or <unk> by year end.
In parallel we are also planning to initiate our platform program with Marriott on a rolling basis in the third quarter.
We also expect updates from the metastatic <unk> European cancer renal cell cancer, and squamous cell cancer of the head net trials later in the year.
In addition, given the promising future of again listed as a first in class drug across multiple solid tumor indications. We are currently evaluating different options.
Potential strategic partnerships to access additional human and financial resources as well as combination drug partners to maximize the opportunity for gander lifted in novel combinations and multiple indications.
I'll now turn the call over to Rob to review the studies, we are initiating this year as well as potential future development path.
Thanks, Edwin our team is diligently working to finalize the design and prepare for the initiation of the first registration enabling study for an analyst.
Mario for and laid the foundation for the next stage of development with Mario P.
The strength of our data across multiple indications and treatment settings provides solid evidence that again are with them a highly specific small molecule inhibitor of the Pi three kinase gamma pathway, they've reprograms macrophages in the tumor microenvironment to enhance immune activation.
Has the potential to be a transformative therapy in immuno oncology.
The consistent positive results, we have observed with the gander with them are very encouraging, particularly in PD lone negative patients who are underserved by checkpoint inhibitors today.
Towards that end, we plan to initiate our initial registration, enabling study called Mario for frontline metastatic <unk> patients building upon the very encouraging Mario three data we presented late last year.
To recap our Mario three metastatic CNBC data demonstrated a 47% and 30% relative improvement in median PFS in PD lone positive and PD lone negative tumors, respectively.
Compared with a benchmark Impassion 130 study.
Mario four will be a randomized double blind registration phase III study.
On the investigational arm all patients will receive the Mario three triplet of again, Alyssa and immune checkpoint inhibitor, and chemo, which will be compared to standard of care, which is either chemotherapy alone for PD lone negative patients, where chemotherapy and a checkpoint inhibitor for PD lone positive patients.
It is important to note that despite recent advances with immune checkpoint inhibitors.
Static TBC remains an important unmet medical need, particularly for PD lone negative patients who still receive chemotherapy alone.
Unfortunately, the vast majority of metastatic PBC patients will succumb to their disease underscoring the continued need for novel treatments.
Following the end of phase II meeting with the FDA in meetings with global regulatory authorities and <unk>.
Anything you will finalize the Mario for trial design and will provide updates on our progress later this year.
One of my highest priorities since joining infinity is to identify other opportunities to advance again, Elisa, particularly in cancers, where immune checkpoint inhibitors have had limited success.
In support of this mission, we will also initiate our Mario P program to evaluate the clinical benefit of a generalist and additional studies to be initiated on a rolling basis, starting in the third quarter of this year.
We will provide more color on this program later in the year.
And with that I'll turn the call over to Larry to review the first quarter financials.
Sorry.
Thank you Rob.
As mentioned in our first.
Full year 2021 earnings call.
This past year has been a foundational year for analysts have an affinity.
Prepare for first Registrational study later this year and prioritize initiation of additional clinical studies in indications, where <unk> has the largest potential benefit for patients.
At the end of the first quarter of 2020 to Infinity had total cash of $67 1 million compared.
Compared to $80 7 million at December 31, 2021.
And research and development expense for the first quarter ended March 31, 2022 was $9 million compared to $8 2 million for that same period in 2021.
This increase was primarily related to new hires during the period, partially offset by a decrease in clinical enrollment expenses.
Continued development of again.
General and administrative expense for the first quarter ended March 31, 2022 was $3 7 million compared to $3 6 million. The same period in 2021 and this increase in G&A expense was primarily due to an increase in stock compensation, partially offset by a decrease in professional services.
Net loss for the quarter ended March 31, 2022 was $12 4 million or basic and diluted loss per common share of <unk> 14.
Compared to a net loss of $1 6 million or basic and diluted loss per common share of <unk> 15.
The same period in 2021.
And to this point too.
Financial guidance remains unchanged.
And so we continue to expect net loss for 2022.
To range from between $45 million and $55 million.
In 2022, with yearend cash ranging from between $25 million and $35 million.
And it's in these financial guidance does not include any additional financing or business development activities.
So that being said 2022 isn't it execution focused here for infinity as highlighted in our previous guidance and later today, we are aggressively advancing development of a robust again lists saverio for first registration study as well as Mario P platform program and other solid tumor indications.
We're excited about the continued advancement of our <unk> clinical program to lay the foundation for initiation of potential future studies.
Parallel will leverage <unk> unique mechanism of action and differentiated clinical data to evaluate and execute on the best path forward to maximize the value began with the for both patients and shareholders.
Will that continue we think that from the team our investigators trial sites.
Especially our patients and their families who played integral roles in advancing our work.
To bring better treatments to patients and thank you for your support and look forward to updating you on our progress in the coming months.
At this time, we can open the call for questions operator.
Thank you, Sir ladies and gentlemen, if we have a question at this time. Please press the star and the number one key on your Touchtone telephone. If your question has been answered or you wish to be self funded queue. Please press two bankey again, ladies and gentlemen, if you have a question at this time, Please press star and then a.
Number one on your Touchtone telephone.
Your first question comes from the line of <unk> with Jpmorgan. Your line is open.
Hi, guys. Thanks, so much for taking my question.
Larry.
Could expand on how youre thinking about your current cash position you mentioned thinking about strategic alternatives here should we be thinking about hey.
We will be addressing our cash needs ahead of Mario <unk> Mario for given potential operational risk if you don't do that.
In the middle of the study.
Thanks, so much.
Sure. Thanks, Tom Tom So.
We've said for some time given the breadth of potential of again a list that we ultimately think it makes sense for to be developed in a partnership.
And the good news is there is an appetite for first in class drugs with unique mechanisms with good phase two data and there just aren't that many of them. So.
Exactly how we determine the optimal mix of <unk>.
Timing of a partnership that will be driven by when it's the right moment and having identified the right partner to help us expand the breath and create shareholder value and what other tools. We use during that process. So it's something that we're actively considering while in parallel.
A real value driver for us is putting all the operational pieces in place for both Mario.
And scenario for us so well.
First of all all of those in parallel.
It's critical for us to have done the financing we did.
The first quarter of last year and to bring in.
Rob is our CMO who has done.
Large studies in immuno oncology.
Most recently working with Celgene.
Gene on PD, one and then BMS with <unk> four.
Regarding the timing of potential <unk>.
Tricia collaboration I'd, just say last time, when we started to a global registration study.
We actually put in the or.
Corporate collaboration.
On the heels of initiating that phase III study.
That one was with Abbvie.
$235 million upfront and $203 million in first year milestone. So there are pros and cons for getting it.
In advance of the.
The phase III theres, some streamlining to actually have.
One person with two hands on the steering wheel as you.
Going through the ft.
<unk> for a review of the Phase III protocol.
Wouldn't.
Prejudge necessarily from first principles are better than the other ones, but our most recent experience was.
On the back side.
Got it thanks, so much for taking my questions.
Okay. Thanks, Thank you Anthony.
Your next question comes from the line of Robyn <unk> with <unk> Securities. Your line is open.
Hi, This is Michelle on.
On for Robyn. Thank you for taking my question.
Just two.
I'll.
A couple questions on partnership if you can give us any update on decisions regarding.
Optimizing what kind of partnerships.
You are planning to pursue.
And secondly, if you can give us any color on the type of combination youre planning to pursue in your model you'll be.
Certainly that would be helpful. Thank you.
Sure. So thank you Shannon.
So what we're looking for in a strategic partnership is two things one.
Maximizing the development expanding the development of <unk>, so that it lives up to its potential. So that's a real key value driver and a partnership structure that create value friendship and paying shareholders and obviously beyond that theres a lot of different structures that would enable us to achieve that so those are two overarching goal.
And related to the expanded development, which we're initiating with Merial piece. There are a number of different we've already disclosed the tumor types that were.
Prioritizing with.
Non small cell lung cancer prostate ovarian soft tissue sarcoma and there are a number of different combinations within that that are interesting and it really speaks to the broad mechanism of a gantlet. There are a lot of combination agents that makes sense.
What we have.
<unk> done historically is we believe its most.
Appropriate to outline those trials when we completed the design. So we finalize the protocol we've reviewed with Reg.
Regulatory authorities with Kols and so we will be providing more detail on those <unk> trials when they are.
The trial design is wrapped up with all the appropriate input and we're ready to kick it off.
Great. Thank you.
Thank you.
Your next question comes from the line of Nick <unk> with Wells Fargo. Your line is open.
Good afternoon. Thank you for taking my questions the.
This one on Mario three.
Renal cell can you remind us what you would view as success in that trial.
Sure. Thanks for the question I'll start, but then I'll turn it over to Rob. So I'll, just remind everybody what the renal cell trial. It is it's combining.
Again, a list with to centric and Avastin in frontline renal cell and.
Rob can talk a little bit more about our objective to that from that study, which is really the signal finding of combining <unk> analysts of width of that Jeff.
And the chemo.
Yes.
Of course.
We are one of the goals of the study is to characterize the whatever efficacy we see with this regimen and also safety, but we think theres a lot of opportunities with the translational medicine side of this to understand.
What is the role of adding a TMA modulating agents like again alyssa to avert Jeff.
I think <unk>.
Success could come in a lot of different flavors, and we're looking forward to kind of digging into that data and sharing it with everyone. Later this year.
And just I correct I misspoke.
With that Jeff and it came out of that Jeff and a checkpoint inhibitor and what we said about that regimen, we know and everyone knows to contract and Avastin is not approved regimen in renal cell. So that's why it's Rob's point is particularly important in terms of looking mechanistically at that combination in any translational data to determine whether.
We wanted to afford in renal cell, but we might at that time be moving forward with one of the next generation digests that are approved in renal cell population.
Yeah.
Okay.
And then at the end of Phase two meeting.
Is this also an opportunity to discuss urothelium flattish to.
I'm, just asking because we wouldnt agreed upon.
Distribution protocol add value to a potential partner for beautiful program.
So I missed the front of that you were asking about weather.
Whether it would be at the end of phase two it's an opportunity to also discuss the UN appealable bladder data.
With the idea being that in the agreed upon protocol that in addition to CNBC.
But presumably add additional value to potential partners.
Yeah.
Okay. So you are talking about reviewing that with the regulatory authorities. So yes.
The phase two meeting yet so we are.
We're really focused on reviewing our Mary of poor trial design and getting worse now of course, when you share. Your data you share all of your data and particularly from a safety perspective, but we're not focused right now on seeking regulatory approval for.
Bladder cancer study, that's not part of our current focus.
Okay. Thank you.
Your next question comes from the line of Thomas.
Roy with children's Research your line is open.
Hi, everyone.
Congratulations on all the development.
Probably a question Pat maybe you all wanted to get a sense of how much of usage in the frontline team be succeeding are you seeing of the century in combination with chemo.
Is it.
In light of the <unk>.
Impression 131.
Are you seeing any pullback in the usage of presenting in the frontline of love to get an idea.
So.
In the U S.
Cause that agent was it test it was pulled it for that indication.
In my own experience clinical and we arent using it says Oh now in the U S.
We're using <unk> analysis the approved agent in first line <unk>. So that's what we're using now of course.
We've been told by Roche and obviously, it's approved in other countries.
So obviously I can't speak to what its usage is outside of the United States.
So you are expecting.
The frontline of.
The trends in Mario.
The rates you can drive them forward.
On likely keytruda to be used in the <unk> region.
Certainly we will plan that will be used as the control arm. So the standard of care for PD, one positive patients only if keytruda and chemo so that would be the control arm and then the PD lone negative patients where no checkpoint inhibitor has been approved the control arm would be chemo, what we've seen.
<unk> for the treatment arm the experimental arm it will be again, a list of plus a checkpoint inhibitor plus chemo in both PD lone positive or negative and we haven't yet named what checkpoint inhibitor will be.
Alright.
And.
The the Mario three renal cancer cohort data.
Is that something we should expect and has more timeline or do you have any.
No detail on that.
We shouldn't we haven't we've just said there will be second half of the year.
Okay, great. Thank you so much for taking the call.
Okay. Thanks for that.
Again, ladies and gentlemen, if you have a question at this time. Please press Star then the number one on your Touchtone telephone.
Yeah.
Your next question comes from the line of Colby <unk> from B Riley Your line is open.
Good afternoon. This is Andy on for Calvert. Thank you for taking my question. How are you viewing the recent OTA AAC votes on advancing <unk> inhibitor with a drug class with respect to requiring randomized trials does the fda's recent ruling on <unk> inhibitors impact again lesser and.
Any sense or your strategy moving forward in indications beyond <unk> or bladder cancer any thoughts on this really would be useful. Thank you.
Yes. Thank you Andy for the question.
Appreciate it because.
We received this question and Theres often.
A constellation of the different tier three kinase inhibitor. So.
There are four different isoforms alpha beta Delta and gamma and they are all very different in their biologic expression and their function and the recent Oh that was focused on the specific <unk> kinase Delta inhibitors in hematologic malignancies, and the accelerated approval Bay.
Just on single arm studies, so that doesn't have any parallel to what we're doing again listed as a <unk> kinase gamma inhibitor. It's expressed primarily on myeloid cells, where delta is expressed on T cells.
We're developing it in solid tumors.
And we do expect that.
<unk>.
The path forward as we've described even in our <unk> registration study will be in controlled studies. So the high level review of our Mario <unk> study is that it will be our triple combination relative randomized to current standard of care, so they really and even follow on questions that.
Have been asked about the old out there have been confirmatory statements that their findings are limited to <unk> kinase Delta limited to Hain limited to accelerated approval on a single arm study. So there really is no read through to with analysts and as you may remember we had a <unk>.
Delta program previously.
It is currently approved.
Because of the some of the side effect profiles that we were aware of through our.
Clinical studies phase one through phase III, we decided to pivot to the person class PSE.
Program.
So those concerning aes, including late August Sept colitis, even like nine months after initiations.
Sure.
The treatment and infections really we've not seen that through our.
350, plus patients.
Have been treated on.
Companion Gantlet studies, so from a.
First principle perspective.
Design of again a list from.
From a chemical perspective, and from our empirical data clinically and translation really.
We have not seen any basis for confabulate in the K.
Delta with or without <unk>, we don't expect any regulatory.
Intermingling of those issues either.
That was helpful. Thank you.
Thank you for the question.
Thank you at this time I am showing no further questions I would like to turn the call back over to ethylene for closing remarks.
Thank you, Sir and clothing in pennies futures very bright we're fortunate to be developing a promising therapy with the potential to improve the quality and length of life for people with cancer.
<unk> is well positioned to execute in 2020 to initiating the first analyst of registration study and expanding evaluation of the game of list or in additional solid tumor indications.
We remain committed to realizing the value of the catalyst for the benefit of both patients and shareholders I'd, particularly like to thank the infinity team as well as our investigators trial sites and our investors and most importantly, our patients and their families who have all played integral role in advancing our work to bring better treatments to patients.
We look forward to providing updates in the coming months and thank you for your continued support.
Okay.
Ladies and gentlemen. This concludes today's conference call. Thank you for your participation and have a wonderful day.
Disconnect.
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Ladies and gentlemen, thank you for standing by and welcome to the Infinity Pharmaceuticals conference call to discuss the company's operations and first quarter blended rent you do financial results. My name is Sarah and I'll be your operator for today's call. At this time all participants are in a listen only mode.
There will be a question and answer session. Chicago. Please be advised that this call is being recorded at Infinity has progressed.
Now I would like to introduce your host for today's call Shane Coffman. Please go ahead.
Thank you Sarah and good afternoon, everyone welcome to today's call to discuss our recent business progress and review of our first quarter 2022 financial results and company highlights on the call with me today are Abilene Perkins, Chief Executive Officer, and Chair, Larry Bloch, President and Robert Lauria Junior.
<unk> Chief Medical Officer will open up the call for Q&A. Following our remarks. The press release issued today details our results and is available on our website at <unk> 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 annual report on Form 10-K for 2021, and then other filings we make with the SEC.
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'd like to turn the call over to Abilene.
Thanks, Jayne and thank you to everyone for joining us today to review Infinity first quarter 2022 progress.
We discussed on our most recent call just five weeks ago 2022 is an execution year in which we are focused on expanding the clinical evaluation of the analysts and additional solid tumor indications and establishing the best path forward to maximize the value of <unk> for patients and shareholders.
We are aggressively advancing the development of <unk>, including the initiation of our first registration trial Mary a four in front line.
Metastatic triple negative breast cancer or <unk> by year end.
In parallel we are also planning to initiate our platform program with Marriott on a rolling basis in the third quarter.
We also expect updates from the metastatic <unk> Europe <unk>.
Answer renal cell cancer, and squamous cell cancer of the head net trials later in the year.
In addition, given the promising future of <unk> analyst.
First in class drug across multiple solid tumor indications.
We are currently evaluating different options.
Potential strategic partnerships to access additional human and financial resources as well as combination drug partners to maximize the opportunity per analysts and in novel combinations and multiple indications.
I'll now turn the call over to Rob to review the studies, we are initiating this year as well as potential future development path.
Thanks, Saddling, our team is diligently working to finalize the design and prepare for the initiation of the first registration enabling study for an analyst Mario for and laid the foundation for the next stage of again, Alex with development with Mario P.
The strength of our data across multiple indications and treatment settings provides solid evidence that again a listen.
Highly specific small molecule inhibitor of the Pi three kinase gamma pathway that reprograms macrophages in the tumor microenvironment to enhance immune activation.
Has the potential to be a transformative therapy in immuno oncology.
The consistent positive results, we have observed with analysts are very encouraging, particularly in PD lone negative patients who are underserved by checkpoint inhibitors today.
Towards that end, we plan to initiate our initial registration enabling study called Mario for in frontline metastatic <unk> patients building upon the very encouraging Mario three data we presented late last year.
To recap our Mario three metastatic <unk> data demonstrated a 47% and 30% relative improvement in median PFS in PD lone positive and PD lone negative tumors, respectively, compared with a benchmark Impassion 130 study.
Mario four will be a randomized double blind registration phase III study.
On the investigational arm all patients will receive the Mario three triplet of Gan, Alyssa and immune checkpoint inhibitor, and chemo, which will be compared to standard of care, which is either chemotherapy alone for PD lone negative patients.
Chemotherapy and a checkpoint inhibitor for PD lone positive patients.
It is important to note that despite recent advances with immune checkpoint inhibitors metastatic TBC remains an important unmet medical need, particularly for PD lone negative patients who still receive chemotherapy alone.
Unfortunately, the vast majority of metastatic <unk> patients will succumb to their disease underscore.
Underscoring the continued need for novel treatments.
Following the end of phase II meeting with the FDA in meetings with global regulatory authorities Infinity will finalize the Mario for trial design and will provide updates on our progress later this year.
One of my highest priorities since joining infinity is to identify other opportunities to advance again, Elisa, particularly in cancers, where immune checkpoint inhibitors have had limited success.
In support of this mission.
We'll also initiate our Mario <unk> program to evaluate the clinical benefit of <unk> in additional studies to be initiated in our rolling basis.
Starting in the third quarter of this year.
We'll provide more color on this program later in the year.
And with that I'll turn the call over to Larry to review the first quarter financials sorry.
Sorry.
Thank you Rob.
As mentioned in our first full year 2021 earnings call.
This past year has been a foundational year for analysts have an affinity.
Prepare for Generalists first Registrational study later this year and prioritize initiation of additional clinical studies in indications, where <unk> has the largest potential benefit for patients.
At the end of the first quarter of 2020 to Infinity had total cash of $67 1 million compared.
Compared to $80 7 million at December 31, 2021.
And research and development expenses for the first quarter ended March 31, 2022 was $9 million compared to $8 2 million for that same period in 2021.
This increase was primarily related to new hires during the period, partially offset by a decrease in clinical government expenses.
Continued development of <unk>.
General and administrative expense for the first quarter ended March 31, 2022 was $3 $7 million compared to $3 6 million for the same period in 2021 and this increase in G&A expense was primarily due to an increase in stock compensation, partially offset by a decrease in professional services.
Net loss for the quarter ended March 31, 2022 was $12 4 million or basic and diluted loss per common share of <unk> 14.
Compared to a net loss of $1 6 million or basic and diluted loss per common share of <unk> 15.
The same period in 2021.
And for these 22.
Financial guidance remains unchanged and.
And so we continue to expect net loss for 2022.
To range from between $45 million and $55 million.
And in 2022 with yearend cash ranging from between $25 million and $35 million.
And it's in these financial guidance does not include any additional financing or business development activities.
So is that what you said 2022 isn't it execution focus to your for Infinity.
Highlighting our previous guidance and reader today, we are aggressively advancing development of a robust again lists of Mario for first registration study as well as Mario P platform program and other solid tumor indications. We're excited about the continued advancement of our <unk> clinical program to lay the foundation for this.
<unk> a potential future studies in parallel we will leverage <unk> unique mechanism of action and differentiated clinical data to evaluate and execute on the best path forward to maximize value begin with for both patients and shareholders.
Will that continue we think that from the team our investigators trial sites and especially our patients and their families who played an integral role in advancing our work.
To bring better treatments to patients and thank you for your support look forward to updating you on our progress in the coming months.
At this time, we can open the call for questions operator.
Thank you, Sir ladies and gentlemen, if we have a question at this time. Please press the star and the number one key on your Touchtone telephone. If your question has been answered or you wish to be self from the queue. Please press to Bankey again, ladies and gentlemen, if you have a question at this time, Please press star and then.
Number one on your Touchtone telephone.
Okay.
Your first question comes from the line of <unk> <unk> with Jpmorgan. Your line is open.
Hi, guys. Thanks, so much for taking my question.
Italy Larry.
Could expand on how youre thinking about your current cash position you mentioned thinking about strategic alternatives here should we be thinking about hey.
We'll be addressing our cash needs ahead of Mario <unk> Mario for given.
Operational risk if you don't do that.
In the middle of the study.
Thanks, so much.
Sure. Thanks, Ana pump so.
We've said for some time given the breadth of potential of analysts that we ultimately think it makes sense for it to be developed in a partnership.
And the good news is there is an appetite for first in class drugs with unique mechanisms with good phase II data and there just aren't that many of them. So.
Xactly, how we determine the optimal mix of <unk>.
Timing of a partnership it will be driven by when it's the right moment and having identified the right partner to help us expand the breath and create shareholder value and what other tools. We use during that process. So it's something that we're actively considering while in parallel.
A real value driver for us is putting all the operational pieces in place for both Mary and Mario <unk>, So well.
Pursuing all of those in parallel.
Okay.
Critical for us to have done the financing we did.
The first quarter of last year and to bring in.
Sure.
Rob as our CMO, who has done.
Large studies in immuno oncology.
Most recently working with Celgene.
Aging on PD, one and then BMS with <unk> four.
Regarding the timing of potential <unk>.
<unk> collaboration I would just say the last time, we started to a global.
<unk> study.
We actually put in our.
Corporate collaboration.
On the heels of initiating that phase III study.
That one was with Abbvie.
$285 million upfront and 200.
$3 million in first year milestone so there are pros and cons for getting it.
In advance of the.
The phase III theres, some streamlining to actually have.
One person with two hands on the steering wheel as you.
Going through the ft.
<unk> for review of the Phase III protocol.
<unk>.
Prejudge.
One is necessarily from first principles are better than the other one but our most recent experience was.
On the back side.
Got it thanks, so much for taking my questions. Okay.
Okay. Thank you Jonathan.
Your next question comes from the line of Robyn <unk> with <unk> Securities. Your line is open.
Hi, This is Michelle on for Robyn. Thank you for taking my question.
Got it.
Just two.
Okay.
A couple questions on partnership if you can give us any update on decisions regarding that.
Optimizing what kind of partnerships.
We're planning to pursue.
And then secondly, if you can give us any color on the type of combination you are planning to pursue.
Certainly that would be helpful. Thank you.
Sure. So thank you Shannon.
So what we're looking for in a strategic partnership is two things one.
Maximizing the development expanding the development of <unk>, so that it lives up to its potential so that's a real key value driver and.
Partnership structure that create value French champagne shareholders, and obviously beyond that theres a lot of different structures that would enable us to achieve that so those are two overarching goal.
And related to the expanded development, which we're initiating with Mary P. There are number of different we've already disclosed the tumor types that we're prioritizing with.
Non small cell lung cancer prostate ovarian soft tissue sarcoma and there are a number of different combinations within that that are interesting and it really speaks to the broad mechanism of <unk>. There are a lot of combination agents that makes sense.
Done historically is we believe its most.
Appropriate.
Outline those trials when we completed the design. So we finalize the protocol we have reviewed with.
Regulatory authorities with Kols and so we will be providing more detail on those Mario key trials when they are.
The trial design is wrapped up with all the appropriate.
Appropriate input and we're ready to kick it off.
Great. Thank you.
Thank you.
Your next question comes from the line of Nick <unk> with Wells Fargo. Your line is open.
Good afternoon, and thank you for taking my questions the.
This one on Mario three.
Renal cell can you remind us what you would view as success in that trial.
Sure Nick Thanks for the question I'll start, but then I'll turn it over to Rob. So I'll, just remind everybody what the renal cell trial and it is it's combining.
Again, a list with to centric and Avastin in frontline renal cell and.
Rob can talk a little bit more about our objective to that from that study, which is really the signal finding of combining a <unk> analyst with that Jeff.
And and chemo.
Yes.
Of course.
We are one of the goals of the study is to characterize whatever efficacy we see with this regimen and also safety, but we think there's a lot of opportunities with the translational medicine side of this to understand.
What is the role of adding a TMA modulating agents like again alyssa to avert Jeff So I think success.
Success could come in a lot of different flavors, and we're looking forward to kind of digging into that data and sharing it with everyone. Later this year.
And just I correct I misspoke.
Does that Jeff and chemo as the veg F N a checkpoint inhibitor and what we've said about that regimen, we know and everyone knows to Patrick and Avastin is not approved regimen in renal cell. So that's why Rob point is particularly important in terms of looking mechanistically.
That combination and any translational data to determine whether we want to go forward in renal cell, but we might at that time be moving forward with one of the next generation digests that are approved in renal cell population.
Yeah.
Okay.
And then at the end of Phase two meeting.
So the opportunity to discuss your paleo bladder data.
Just asking because it wouldnt agreed upon registration protocol add value to a potential partner for the <unk> program.
So I missed the front of that you were asking about weather.
Whether it'd be at the end of phase two it's an opportunity to also discuss the ceiling.
Bladder data.
With the idea being that in debride upon political bed. In addition, the CNBC.
Presumably add additional value to potential partners.
Okay.
Okay. So you are talking about reviewing that with the regulatory authorities. So yes.
To my right.
Yes.
We.
I'm really focused on reviewing our Mary of pork file design and getting <unk> of course, when you share. Your data you share all of your data and particularly from a safety perspective, but we're not focused right now on seeking regulatory approval for.
Bladder cancer study, that's not part of our current focus.
Okay. Thank you.
Your next question comes from the line of Samad ROI with children's Research. Your line is open.
Hi, everyone.
Congratulations on all the development.
Hi.
Probably a question Pat maybe you wanted to get a sense of how much of usage in the frontline team. This is hitting.
Are you seeing of the century in combination with chemo.
Is it.
In light of the <unk>.
<unk> 131.
Are you seeing any pullback in the usage of presenting in the frontline of love to get an idea.
Okay.
So.
In the U S.
That agent was it is it was pulled it for that indication.
In my own experience clinical and we arent using a Tesco now in the U S.
We're using <unk> analysis the approved agent in first line <unk>. So that's what we're using now of course.
We've been told by Roche and obviously, it's approved in other countries.
So obviously I can't speak to what its usage is outside of the United States.
So youre expecting.
The frontline of.
The trial Mario.
The rates that can drive you forward focus on likely keytruda to be used in the <unk> region.
Certainly we will plan that will be used as the control arm. So the standard of care for PD, one positive patients only is keytruda and chemo, so that would be the control arm.
And then the PD lone negative patients where no checkpoint inhibitor has been approved the control arm would be chemo, what we've said for the treatment arm. The experimental arm. It will be again, a list of plus a checkpoint inhibitor plus chemo in both PD lone positive or negative and we haven't yet named what checkpoint inhibitor will be.
Alright.
<unk>.
The Mario three renal cancer cohort data.
Is that something we should expect and has more timeline or do you have any.
Final detail on that.
We show that we haven't we've just said there will be second half of the year.
Okay, great. Thank you so much for taking it.
Alright, thanks for that.
Okay.
Again, ladies and gentlemen, if you have a question at this time. Please press Star then the number one on your Touchtone telephone.
Okay.
Okay.
Your next question comes from the line of copies Patel from B Riley Your line is open.
Good afternoon. This is Andy on for <unk>. Thank you for taking my question. How are you viewing the recent ODI received votes on advancing <unk> inhibitors as a drug class with respect to requiring randomized trials does the fda's recent ruling on <unk> inhibitors impact again is lesser than any.
Or your strategy moving forward in indications beyond CNBC or bladder cancer any thoughts on this really would be useful. Thank you.
Yes. Thank you Andy for the question, we appreciate it because.
We received this question and Theres often.
A conflation of the different <unk> kinase inhibitor. So.
There are four different isoforms alpha beta Delta and gamma and they are all very different in their biologic expression and their function and the recent <unk> was focused on the specific <unk> kinase Delta inhibitors in hematologic malignancies.
And the accelerated approval based on single arm studies, so that doesn't have any parallel to what we're doing again listed as a <unk> kinase gamma inhibitor. It's expressed primarily on myeloid cells, where delta is expressed on T cells.
Developing it in solid tumors.
And we do expect that the <unk>.
Path forward as we've described even in our <unk> registration study will be in controlled studies. So the high level review of our Mario <unk> study is that it will be our triple combination relative randomized to current standard of care, so they really and even follow on questions that.
I've been asked about the <unk> there have been confirmatory statements that their findings are limited to <unk> kinase Delta limited to Hain limited to accelerated approval on single arm studies. So there really is no read through to again, a listen as you may remember, we had a <unk> <unk> Delta program previously.
<unk> is currently approved.
Because of the some of the side effect profiles that we were aware of through our.
Clinical studies phase one through phase III, we decided to pivot to the person class PSE K Gamma program and so those concerning aes, including late August Sept colitis, even like nine months after initiations.
The treatment and infections really we've not seen that through our.
350, plus patients.
Have been treated on.
Companion studies, so from a <unk>.
First principle perspective.
Design of <unk>.
From a chemical perspective, and from our empirical data clinically and translation really.
We have not seen any basis for confabulate the patriarchy.
Delta with or without <unk>, we don't expect any regulatory.
Intermingling of those issues either.
That was helpful. Thank you.
Thank you for the question.
Thank you at this time Im showing no further questions I would like to turn the call back over to Abilene for closing remarks.
Thank you, Sir and closing in pennies futures very bright we're fortunate to be developing a promising therapy with the potential to improve the quality and length of life for people with cancer.
<unk> is well positioned to execute in 2020 to initiating the first analyst of registration study and expanding evaluation of the analysts have in additional solid tumor indications.
We remain committed to realizing the value of the catalyst for the benefit of both patients and shareholders I'd, particularly like to thank the infinity team as well as our investigators our trial sites and our investors and most importantly, our patients and their families who have all played integral roles in advancing our work to bring better treatments to patients.
We look forward to providing updates in the coming months and thank you for your continued support.
Okay.
Ladies and gentlemen. This concludes today's conference call. Thank you for your participation and have a wonderful day you may all.
Disconnect.