Q1 2020 Earnings Call

Ladies and gentleman did you see operator today's conference is scheduled to begin momentarily.

Until that kind your lines will once again be play so many school.

And your confidence is scheduled to begin momentarily. Thank you for your patience.

[music].

Ladies and gentlemen, thank you for standing by and welcome to the Infinity Pharmaceuticals conference call to discuss companies operations and financial results for the first quarter 2021.

My name is the lane and I'll be your operator for today's call.

At this time, all participants are not listen only mode.

It will be a question answer session to follow.

Please be advised that this call is being recorded and fit at these requests.

Now I would like to introduce your host for today's call Jane Kaufman. Please go ahead.

Thank you Alain and good afternoon, everyone welcome to today's call to discuss our recent business progress and review our first quarter 2020 financial results on the call with me today are Adelene Perkins, Chief Executive Officer, and Larry Block President well open up the call for Q1 eight following our remarks.

The press release issued this morning details our results and is available on our website at MP Dot com.

Please note that during this call we may make forward looking statements about our future expectations 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 factor section of our annual report on form 10-Q for the first quarter of 2020, and then other filings we make with the FCC.

These forward looking statement men's preprint 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 the idling.

Thanks, Jane and thanks to everyone for joining us today.

I'd like to start off today's call by recognizing the unprecedented.

Circumstances, we are facing add infinity and throughout the entire life Sciences community with the ongoing cobot 19 pandemic.

Well Cobot 19 has created new challenges that we are pacing together as a community. It has also highlighted the dedication commitment and innovation that is a loud and continued advancement desperately needed treatment for patients.

We remain committed to our plentiful approach, which is designed to demonstrate central benefit by Cadfive 0.9 treatment for the patients in our trials, who have some of the most challenging cancers with poor prognosis.

It's imperative that they have continued access to treatment and that you said development promising new therapies continues.

I'm, particularly proud of our team and infinity, along with our collaborators and investigators are continuing to prioritize safety applications and team well still enabling our progress in the clinic continue.

As a reminder, a clinical program for I'd, just like frontline has multiple ongoing trials, including marry up to 75 are randomized controlled phase two study in collaboration with CMS.

Evaluating I guess I fourninety combination with Opdivo in patients with advanced Urothelial, what bladder cancer.

Marriott three our phase two study in collaboration with Roche Genentech.

The combination of I guess 5.9, with Patrick and Abraxane.

Frontline treatment in patients with triple negative breast cancer or can be seen in combination with to centric and that's been has a frontline treatment for patients with renal cell cancer or RCC.

We also have marry a one phase one one be study in collaboration with Bristol Myers Squibb evaluating I check back for nine in combination with Opdivo in patients with advanced solid tumors.

In addition to these attendees sponsored trials are collaborator ARCUS buys sciences is running a phase one study evaluating <unk> 5.9 in a novel checkpoint inhibitor free regimen that includes their dual adenosine receptor inhibitor ABT actuate and doxil in patients with relapsed refractory.

Triple negative breast cancer.

I'd now like to review the current status updates of our studies.

From area to 75, we were pleased to announce the U.S.F.D.A. granted fast track designation fried Cadfive Tonight.

Combination with a checkpoint inhibitor opdivo for the treatment of patients with advanced Urothelial cancer.

Fast track designation is an important acknowledgement both the unmet need for these patients and the potential of this regimen to improve patient outcomes.

As you May recall married to 75 is our controlled randomized phase two study evaluating I pad sites, one night in combination with Opdivo in platinum refractory immunoncology naive patients with advanced Urothelial cancer in collaboration with CMS.

The objective of this controlled study is to evaluate potential benefit of adding CAD 5.92, Optivo monotherapy building on the exploratory biomarker data from the BMS Checkmate 275 study.

Demonstrating an association between high levels of my like.

Hi, baseline levels of myeloid derived suppressor cells or Mds C.

Lower median overall survival.

Well as you need to marry a one study showing that treatment without cadfive 0.9 reduced N D C level and the majority of patients treated.

These data suggest that I checked by 49 has the potential to further improve outcomes beyond what we've seen with Opdivo monotherapy for this patient population.

In todays press release, we shared that we recently held the first scheduled marry up to 75 independent data monitoring committee or Idmc needing.

To review the safety data on the initial 42 patients treated in study.

In the 42 patients liver enzyme elevations, a great tree and higher foreseen seven patients.

Right right into with Great for one of which was newly absurd and has not yet been reviewed by the idea thing.

The liver enzyme elevations from the six patients that were reviewed by the idmc reversible and have resolved without well.

Up to 17 patients that were evaluable for efficacy.

Adjusted for sponsors have been observed both in patients with great free and involved liver enzyme elevation.

Well as in patients without sees elevation.

Today, we received written communication from the Idmc, which was consistent with the safety management plan, we communicated to our site earlier in the day, which included the continued treatment of patients now on study with additional patient monitoring and suspension of new patient enrolled.

Okay.

Pending a review of additional data our objective is identical to identify changes to or redesign of the protocol to support resumption of new patient enrollment in the future.

In addition to the Idmc recommendations, we instituted a reduction in the dose of Ipi five cents for nine from 40 milligrams to 30 milligrams once daily with no change to the Opdivo goes.

We're comfortable with the pharmacokinetic and Pharmacodynamic.

30 milligram dose because as previously presented there is near complete and sustain inhibition of Pithree kinase Gamma would die cast platform nine monotherapy.

Delta of 20 milligram once daily into bugs.

The issue, we're dressing regarding you see an L.P. liver enzyme elevation.

He is in the context of the package insert and prescribing information for Opdivo.

Which recommends that just contagious discontinuation of Opdivo following break free liver enzyme elevation.

This is the result of that one 5% of current up a Q auto immune hepatitis English that's either as a monotherapy and in combination with its a little on that.

It is difficult to distinguish between the liver enzyme elevations dude lucky, though and I guess I for nine so we're taking a prudent approach in pausing enrollment of new patients, while we analyze the data.

Our goal is to develop a protocol amendment that ensures patient safety, while enabling us to evaluate potential benefit by 5.9, plus up the though an advanced bladder cancer patients.

Now transitioning cool brief update on married three.

As a reminder, there are two cohorts in its ongoing phase two study.

One of Valuating CAD 549 in combination with centric and the Braxton as Bret mentioned, the frontline therapy in patients with triple negative breast cancer and another evaluating high tech platform in combination with to centric and that's done at the frontline therapy for patients with renal cell carcinoma.

The Marriott treat multi cohort study absurdity RCC patients.

He can be C patients is being conducted in approximately 25 sites in the U.S.

Well some tight enough initiation activities have been conducted remotely married Threeq site initiation has been negatively impacted by cobot 19, and we're working to initiate additional sites over the coming month.

Independent of the impact to cope with 19. The TNBC cohorts is also experiencing initial enrollment and site initiation delayed, which we're working closely with ours to euro and investigators to address.

By working with site and investigators to leverage early site initiation enrollment experience inside can be generated to inform new site initiation in patient recruitment initiative.

So cold midnight team has limited our assets just sites over the past month and made this work more challenging we have identified in our implementing initiatives designed to accelerate site initiation in T. NBC enrollment.

Despite these challenges a number like have continue to enroll patients, which is taking place on a patient by patient basis with investigators after carefully evaluating the ability of patients to stay and treatment and follow study protocol visits and procedures.

[noise] in early April we provided an update regarding the potential impact to poke at 19 on our clinical program.

Well the situation continues to evolve we can confirm that the pandemic is negatively impacting patient enrollment in site initiation across our clinical program.

Patients enrolled in married up to 75, Marriott three and Merial ones have continued treatment and studied visits with limited disruption today.

Cindy's working closely with trial sites to protect the health and safety of patients unparalleled like personnel to enable the continued treatment of patients while maintaining compliance with protocols to ensure study integrity.

We have not experience and do not anticipate any hope at 19 related disruption to drug supply for ongoing trials.

The patient centered proud to have extremely challenging to treat cancers, often with poor prognosis, even when we're committed to trying to ensure that they can say from continued assets treatment and that we can continue the development of drugs central.

<unk> meaningful patient benefit.

We anticipate being able to provide an update on are plentiful programs and financials I fire second quarter webcast.

Moving now to corporate update we were pleased to add Dr., Richard gain or court board of direction Correctors, Richard has a well established track record of success, including senior roles at Nanotherapeutics and Lilly oncology.

We're thrilled to have them onboard and already benefiting from his insight.

We're also proud to establish a world class clinical Advisory Board, we believe will provide unmatched sides nets for Keith as we advance our I've cadfive for an IDE clinical pull them.

Before transitioning all over to Larry I'd like to acknowledge that it is challenging for us and you as valued stakeholders that were not able to provide concrete guidance on one week after completing enrollment or have data from our filed.

Well I wish I could be more specific given the evolving circumstances were unable to make more definitive statements on timelines at this time, but look forward to updating you as we have additional clarity.

Finally, I'd like to take a moment to acknowledge the incredible work and commitment we have seen from our team and infinity. Our investigators in are fantastic collaborators at CMS roast genetic and ARCUS, particularly during these unprecedented in challenging times by working together, we're ensuring that our progress continues and hope these.

Effortlessly to meaningful improvements for patients in need and with that I'll turn call over to Larry.

Exactly.

As we discussed or less coal in January we completed.

$20 million, that's about financing I would be this partners.

So over the course news, but since really payments due on future sales.

But again, that's a hedgehog inhibitor pathway inhibitor.

Just everybody studies, which we licensed Olkaria back in 2013.

Yeah. This financing enable us provide guidance last quarter existing financial resources were sufficient to fund all work ongoing clinical programs from key data read outs, but.

Due to the delays related to cool nights, you'd said domestic as well.

Let me discuss specific <unk> three.

As well as.

The.

How many fox, especially enrollment no longer belief or current resources will be sufficient to fund this milestone.

Oh to the restricted cash runway into second half from 2021, we do recognize that will need to find.

Cost savings Inrsixty folks up resources to fund a good life when on studies through these keeping rooms.

Turning to our first quarter financial results at March 31st 2020.

We had total cash cash equivalents cannot be <unk> steel securities.

$2.3 million compared to 42.4 million, but then it last year at December 31st 2019.

During the first quarter 2020.

Yes, they did recognize the $20 million.

Gross proceeds from.

Net of transaction cost liability there will be amortized using that took its interest method.

Over the full life of the arrangement in accordance with accounting guidance.

Well I recognize this is a liability for purposes of accounting.

Companies not obligated to pay the $20 million.

Turning to R&D or restricted old expenses for the first quarter 2020.

$7.3 billion compared to 6.8 billion for the same period in 2000 <unk> My team and did you increase in R&D expense in 2020 compared to 20 like gene was primarily due to an increase in clinical end Goldman activities for I tried but we're not.

<unk> expense was 3.3 million through the first quarter 2020, compared to 3.4 million for the same period in 2019.

Net loss for the first quarter 2020 was 10 point, Ninemillion, where basic and diluted loss per common share by two cents.

Burger net loss for 13.7 billion.

Basic and diluted loss per common share 24 cents, the same period and 20 like needs.

[noise] official guidance remains unchanged, we expect 2018 net loss to range from $46 million, Let me start and 2020 with the cash investment balance ranging from 2015 $25 million.

Based on current operating plans, which exclude additional funding orbitz depomed activities.

We do anticipate the existing cash cash equivalents integral to sell securities will be adequate to satisfy our needs in the second half of 2021.

But the most guys does not include potential funding we're developing activities.

Including Central 5 million dollar milestone payments from <unk>.

Upon coliforms ongoing phase three clinical trial.

I get topical gel and Gorlin syndrome.

40 milestones from or the sale the Companys equity interest in California. So.

So what was going to say, we really appreciate your patience as we continue to work to understand the ultimate impacts on timelines for enrollment and data read outs.

And we look forward to be able to find update on a clinical programs you know going from guidance.

Q2 webcast.

This time a call for questions operator.

At this time, we can open the call for questions.

And if he would like to ask a question you May press star and the number one on your telephone keypad.

Yes star and the number one and we'll pause form only two compiles acuity roster.

[noise].

I knew Pam Rama your line is open.

Yeah, Hey, guys. Thanks rich.

And then motivations word reversible. So we're just wondering if you can comment on the typical times resolution.

For these events and if you have to get off the top you've had maybe how it compares to what you might expect from a opdivo sorry upheaval alone.

And then on Marios three.

On the enrollment, but initially initiation delays I guess do you have any theories here on the non uncoated impact.

And then can you give us a sense of how many of the 25 sites our experience experiencing these aren't cobot delays. Thanks, so much.

Sure So and you broke up a little bit at the beginning so but.

I would your first question, how long it takes or the liver enzyme elevations to resolve.

Yeah, that's correct, yes, yes, so that for the sick patients. It will review the they resolve very quickly so the patient cohort on adults Holden and end the resolution was very rapid and as we said without any to qualify so we're comfortable with the the speed and number.

And the reversibility as I mentioned, we're really focused on the challenge of differentiating from the the the more acute.

The autoimmune hepatitis that's in the upheaval label and so that's why we're doing the pause to figure out how to make sure. We can safely enrolled patients going forward [noise].

On your second question on Marriott three.

Oh sure experienced challenges with site initiation for the can be see cohort were working with them to address collecting data from the sites to understand you know, whether it's strictly operational and administrative in terms of perceiving that necessary approvals to initiate the flights or whether there's any other factor play that we need to address that we're collecting that data now.

Okay, and then if I may just sneak one more and the press release mentioned that there's one new he observed crude for AG Ah. So just wondering when that though in the next meeting is one that will be reviewed the data monitoring committee.

We don't have the net meeting schedule, yet with the Idmc and so we we are looking to have discussions with the idmc about the additional data and analysis that will be collecting and so we will probably review it at that time in general we have planned.

In the meeting scheduled in trouble and so.

This one may be repute, when we are reviewing some of the data that will be classic.

Gotcha, Thanks for taking my questions.

Sure Thanks, everyone.

And your next question comes from the line of Kevin Degeeter from Oppenheimer.

Okay, great. Thanks for taking my questions, perhaps the with regard to the liver enzyme observations you could you put those in context to the phase one be experiencing thing.

So even going back to sit seen maybe about two years ago is interesting first or where you wanted about.

82 patients share the rates there yeah were somewhat elevated from some of the data it would seem from nivo alone across different histologies, but my question here is.

You know what's sort of.

You order of magnitude a of the increase here is notable for the Wendy but it's not a dramatic step up. So you know I just wanted to think make sure I'm. Appreciating. This is just sort of in L.P.L.A.S.T. issue or is there sort of other aspects of the clinical presentation of some of these seven patients.

Inform the decision to Paul's enrollment.

So Kevin.

As as you mentioned, we have seen great screen liver and.

Liver enzyme elevations in our phase one what we're focused on with the Marriott to 75 is that it's a frequency of these events. So we're seeing them.

At a higher rate than we saw them and in Merial one and.

The reason that were pausing enrollment is again because of this.

You know relatively rare, but important acute autoimmune hepatitis that came with opdivo monotherapy in the past that we can't distinguish between the two so we've really got to get in and dig into the PK and PD patients that we dose to date to better understand that.

We can assure our goal is to reduce the frequency of the great free liver enzyme elevations and so that's our goal.

That's a combination what we're doing with the patients that are on study right now we've reduced the dogs were doing more frequent monitoring and so our objective is to reduce the frequency with which we're seeing those grade three elevation.

Great now makes a lot of sensor that maybe just one more for me that is here. We appreciate the update with the odd mario's free or for the T. M. B C code work. It can you just remind us with regard to DRC car cohort.

Where are you are there in terms of a number of open sites and what was the prior guidance with regard to an update on my back or.

Sure. So our prior guidance on renal cell was that we would complete that's a 30 patient cohort that we would complete enrollment by the end of this year and Hep preliminary data.

And we.

Our still the only effect to that timeline that unchanged, but for posted 19 until we haven't had any delays that are not related to cope with 19, how we're really working with our sites now to try to understand how quickly they are going to be able to resume.

Besides initiation enrollment coming out of Coke 19, so that we can quantify what we have provided updated guidance that we no longer except to complete enrollment by the end up 2020.

And and that the completion of enrollment and the availability of data will be pushed into 2021, but we were we want to be able to provide more granular timeline, but we need to do more work with our sites to understand when they hope to come out of the cobot 19 slowdown.

That's great and then maybe just building on that.

Last observation as sort of my final question that is what we think about you know burn rate for the for the year you Directionally yeah. It would seem to the puts and takes would be towards a lower.

On right from kind of the prior baseline expectations.

You know a more aggressive enrollment trajectory.

You Larry or are there any you know.

Items that might not be transparent, we think about sort of or increasing the expense side in spectrum.

You know perhaps related to covert 19 directly that we should be mindful as we think about.

Yeah. The flexibility you may have and balance sheet management.

Sure Good thing thanks for the question.

So yeah, I think in terms of the cash management and cash burn.

First quarter tends to be one of our or higher orders because you have sort of annual bonuses prepays and its wells drilled purchases for the you ongoing clinical trials.

So it's likely that the first quarter will be what or our highest burns, but in terms of you know things that might be happy when going forward basis, you can obviously think about mitigation efforts.

Said, we're trying to work this year olds sites to understand.

What's the enrollment dynamics ours, I, just had issued dynamics and if there's ways that we can potentially.

Accelerate those and of course those could be.

Yes.

Require additional.

One thing from us in order to to try to move the enrollment and you saw initiation or more accelerated pace.

Appreciate the additional color. Thank you both so much.

Thank you Kelly.

And your next question comes from the line of Jim Kirsch enough from Wells Fargo.

[noise] [laughter] completing its a nickel Jim so [laughter].

[laughter] Christian just going back to.

Announcement from 275 on the liver enzyme elevations. So this is a two to one randomization. So cost me 28 patients.

Would have baked into combination can you break down fours.

So these grade three or four events between.

Combination versus Opdivo monotherapy.

Yeah. Thanks, Nick.

As you know this is a blinded study and so were we're not able to do a breakdown of either E or observers clunkers, because it's really critically important that we not breaks up line. So that we can maintain the integrity of the study so I'm, sorry, but we're not able to breaks up line data.

[laughter], but the Idmc has.

Yes, yes.

Okay.

No you quoted the rate of autoimmune hepatitis a full give as a monotherapy, but obviously it's high.

With U.S. only two suggesting.

Potentiation of this toxicities and.

You know one one is a home school mechanisms to find for nine is to improve immune status.

There are concerned that you know you might be potentially 18.

Signal list that's from Optivo businesses.

Something that's to do with high school nine alone.

I never really <unk>, a great question, but again, because we can't.

Again bye.

The adverse events and whether they are on the treatment arm or the control arm can't break down whether we think there mechanistic mechanistically tied to Ipi 549. So.

Sorry, again, it would just require okay [laughter] the cure poisons Larry.

It's it's a insightful question and we talk about evaluating the the you know risk benefit for patients.

That's exactly what we're trying to understand in the context of a blinded study with the Idmc.

[noise] and then I'm interested to know if this has any impact on merian. Three are you considering reducing the dose of 5.9 various reasons. It's also in combination with a PD one checkpoint inhibitor.

Right so.

Marriott's free as you know is a different combination in the different patient populations. So we're really evaluating it independently, but looking very closely at both the safety and the signals of efficacy in that patient population. So you know what we will be paying very close attention to liver enzyme melody.

Jason So we'll be looking at the actual data in the.

The Triple negative then and renal cell page.

Okay. Thanks, and then just last one from me and that is.

He would you consider terminating Marianne three to get you through to the finishes to 75 with the runway or even perhaps a.

It's been more trouble on T.N.B.C. cohort.

We haven't made any just that we havent had any discussions around you know how we might change our our portfolio. So right now we're really just focus on how do we continue with the trials and how do we.

Moving forward, we have we haven't had any other discussions at this point yet.

Okay.

Thanks and report for the next topic.

Taking a step.

And your next question comes from the line up.

<unk> ROI from Jones trading.

Hi, there thanks for getting the question.

Could you give us a little.

And so when we will give an update on.

On the seater met your 2005 enrollment.

The the macro weakness or we're going to go second quarter earnings.

Oh, you could of course and ready we will get all interim look of the detail you were weak until the entire Crosby Coconut Creek and you want.

Yes, two minutes so thanks for the question.

We expect to provide an update on the second quarter call, which will be very end of July or beginning of August.

And so in that time, we will have you know.

Hey, analyze the data and and worked on a protocol amendments that would allow us to proceed and we would it will provide an update on where we are in that in that process by the second quarter call I don't expect that we'll be sharing any of the data from these first 42 patients that we reviewed with the idea.

See again, because it's a blinded study I do except that we won't have the data from this study until its completed.

Got it.

Do you do the distribution like being self.

They are coming from one center or he's got a possibility we should have been infected by saw Scooby Doo and cause any commission of call. It just one distributor on two different size.

The last question is do we know.

Do we know which cohorts from Mario one end up this year, we're going to see a deal.

So first on understanding whether there there's a concentration of any liver enzyme elevations that site. That's that's precisely the data that we're digging we're gonna be digging in is it looking at each of the sites where these happen is there anything that will expire.

Playing the elevations that weve seen a and so that's that's really the focus so looking at the site looking at the individual patients looking at you know any conmeds any previous history. So we're really going to be digging in and that's that's that's really why we put the new enrollment on pause until we can go in and do.

I think it so those are the key questions and answers that will try to get going forward.

And you know with respect to marry one is as we said were conscious of.

I will absolutely be presenting the full dataset at some future point any update that we do a before the studies fully completed will be tied to.

Any additional studies that might be.

Suggested by the data so that would if there's data that's coming out of married one that will inform our interest in pursuing additional trials. That's the data that will be prioritizing for presentation until we have the whole study completed and present, the comprehensive clinical and translational dataset at.

On future points.

Thank you so much.

<unk>.

And your last question comes from the line up Andrew Dsilva from B. Riley F B R.

Good afternoon Ah. Thanks for taking my questions. This is the way we won't for Andy So just to feel question from us to start could you give us additional color on what we should expect in terms of amendment.

Do you now related to the size and are you still going to be able to utilize the data from the patients that were in road thus far.

So thanks for the question I I can't.

Provide any insight on what maybe in a protocol amendment, because that's really going to be informed by the analysis that we'll be doing so we left it you know some of the keep questions are around the pharmacokinetics and pharmacodynamics and one of the reasons that we paused new enrollment is that that data that we need to go get and analog.

So that would form.

Our our suggested protocol changes so that will really be data driven and the second part of your question, yes, because and that's of wells up 42 patients.

The included an analysis, yes, they will be which is why were being so rigorous of ensuring the study blind and not providing any data that unblinded either for safety or from efficacy with respect to where those events have occurred on either the treatment arm or the control arm. So.

We're taking great lengths to ensure that should keep the blind so that those patients will be counted towards the ultimate analysis from the study.

Okay, Thanks, and as it relates to the as by motivations, where see could you. Please refresh our memory and let US know what you would have expected for patients upheaval alone.

Well was initially seeking that real one and also does because he knows that each and your thoughts on their religious about five ability to be a registrational study.

So what what we've seen in marry up to 75.

Higher frequency of the grade three levers liver enzyme elevations and we thought in our grade in our phase one study. So we we've seen an increase and that's what we're really doing the you know detailed detective work now to understand exactly why we're seeing greater frequency.

When.

When we finish that analysis and our goal is to identify protocol amendments that will enable us to continue to safely dose patients I'm told that we can evaluate what we still hope will be a benefit for these advanced bladder cancer patients of the combination of Opdivo and 549.

Uh huh.

In in finding a path to go forward.

And completing this study which is our our goal you know if if the data.

Suggest.

That we that there's a significant benefit we will have discussions with regulatory authorities about what is the best path to approval, but ultimately our goal is to to seek approval in this with this regimen in this patient population and that will all be up a function of the data that we're able to generate.

Yeah, I think just learned I think what's it worth emphasizing is that for the the.

A few increases the reviewed by the Idmc. Your those were we're still going to date resolve itself. That's Nicholas but critical is issue is in the context.

The opdivo not just the.

Liberalizations, but the 1% to 5% occurrence of acute autoimmune hepatitis and so that's really the.

Contest with which we're trying to analyze this data that sure patient safety.

It's not sort of realty is tea.

Elevations of the abstract, but but how they may or may not.

Result in.

Great people, who runs I know the patients who were higher in acute autoimmune hepatitis.

Okay, So what a color.

Couple of more quick ones. If I may could you. Please give us an update I'll be competitive landscape specifically as it relates to P.I. three take alma has there been any updates.

And so on the.

Our accused milestones under like pre clinical candidate as well.

No. We what I can tell you is that we watch carefully if there any other yes, we kinda gamma specific inhibitors in clinical development and we're not aware of any others that are in clinical development. We know that there are some that are in preclinical development, but we don't know what the.

Data says of the move up those those drug candidates into the clinic.

Yeah, the choosing care.

They are Astra Zeneca, she said ARCUS buyers.

Okay.

Finally, as it relates to our kids because their work with the P.I. recreate government candidate tens or thoughts on collaborating with them going forward.

No we were very aware that they have an interest in this mechanism and that they have a preclinical program and they've been very forthcoming I think we both share an interesting thing what's the clinical benefit of the combination that we're testing together with their dual adapting.

And happiness and Doxil. So we both have an interest in and generating that data.

Okay. Thank you very much and best of luck going forward.

Thank you great. Thank you so much.

And you have a follow up question from Jim that's enough from Wells Fargo.

Oh, Thanks for taking the poll of time [laughter], although they may because we didn't need to pay suncors increase I love to scare steroid treatment pool, presentable, which I mean appetite.

Yes, they have.

[noise], Thanks, and then.

The going forward they will get 30 milligram dose or is it really cool hasten to come who will come onto the trial books dog.

No that it's the patients who are currently on study that we.

Sent a letter to the sites asking that those patients who had Bennett 40 year old reduced to 30, we we have not yet described what would be in a protocol amendment for new patients. So that's really going to be a function of us completing the analysis and determining what if any dose.

Reduction is appropriate for an ongoing protocol amendment, that's been who really driven by the data that will collapse. So it's premature for us to talk about what's going to be in a future protocol amendment at this time.

[noise] and then finally food should we expect the partial clinical hold who will be price placed on this.

Trial.

[noise], so yes I.

I think it's important differentiator no regulatory.

Termination is Ah you know a sponsor idmc. So the idea of C. Myc recommendation the sponsor infinity.

You know either accepts or in this case, we actually augmented their recommendation with the girls production and Ah today, there's been no regulatory actions on fought for nod.

[noise], thanks to the clarification.

Yep.

[noise] [noise]. Thank you at this time I'm showing no further questions I'd like to turn the call back over to idling for closing remarks.

Thank you for participating on call. This afternoon. We appreciate your interest in Infinity and I can't find for nine and we're very committed to continuing our progress on the development of I can't 549 to.

With the goal, helping patients who really need better therapies and so we look forward to updating you in the coming month.

And hope you have a nice even.

Okay.

Thank you for joining today's conference call.

You may now disconnect your line.

[noise].