Full Year 2020 MEI Pharma Inc Earnings Call
[music].
That's an up your operator for today's call. Please stand by that the call is be <unk> at the company request.
At this time I'd like to join the call over to David Wadley, EMEA Eyes, Vice President Investor Relations Corporate Communications. Please proceed.
Thank you been Esa and good afternoon, everyone. Thank you for joining us today after the market close today, we filed our form 10-K for the fiscal year ended June 30, 2020, with the Securities Exchange Commission and issued our financial results in corporate highlights press release, both of which are available in the investor section of our website at www and the.
Pharma dotcom.
On our call today by the summary financials from the fiscal year ended June Thirtyth 2020, and then review progress in our programs and business over the last year. You. We'll then open the call to your questions before we get started I want to call. Your attention to the fact that this conference call may contain certain forward looking statements within the meaning of the safe Harbor provisions of the product private.
Securities Litigation Reform Act of 1995, you should be aware that our actual results could differ materially from those contained in its forward looking statements, which are based on management's current expectations and are subject to a number of risks and uncertainties as discussed in our SEC filings, including our most recent annual report on form 10-K filed earlier today.
A replay of this call will be available on our website approximately an hour after its conclusion.
I'd now like to introduce you to our speakers for today with me today, our Dan Gold, our President and Chief Executive Officer, and Brian tries to our Chief Financial Officer. Additionally, David or so our Chief operating officer is also with us today.
Brian will start with a summary of our financial results before Dan shares remarks, reviewing the commenting on the coming quarters. After that we'll open the line for your questions I'll now turn the call over to Brian.
Thank you David.
Provides a brief overview of financial results for more detailed information regarding our financial results I invite you to review our form 10-K filed earlier today.
Im pleased to report that we finished fiscal year 2020 with about $183 million in cash cash equivalents and short term investments with no outstanding debt.
Additionally, we have a receivable of $20 million that is expected to be received from the Japanese taxing authorities in fiscal year 2021.
That was withheld from the $100 million paid by K K C. Under the terms of our April 2020, Global license development and commercial commercialization agreement.
Holding was a result of the US internal revenue service being closed because of the Kobin pandemic.
Resulting in an inability to.
Provide the necessary documentation to support an exemption from the required foreign withholding.
This has us starting our new fiscal year pro forma with about $203 billion in cash and short term investments.
We recognized revenues of 28.9 building for the year ended June 32020, compared to 4.9 million for year ended June 32019.
Revenues resulted from the recognition of license revenue associated with that Q lecture and license agreement as well as fees allocated to research and development activities related to the Q accurate and helps and license agreements.
Adjusted net loss for the fiscal year ended June 32020, excluding non cash expenses related to changes in the fair value of the warrants issued in connection with our May 2008 financing a non-GAAP measure was $23.1 million met.
Loss was $46 billion or 51 cents per share for the fiscal year ended June 30, 2020, compared to net loss of 16.8 million or 24 cents per share for 2019.
The company has 111 500.
Thirteensix hundred 89 shares.
A common shares outstanding as of June Thirtyth, compared with 73.545 million shares as of June 32019.
In summary, we started fiscal year 2021, and a strong position to continue advancing our programs and general business efforts with that I'll turn the call over to debt.
Thanks, Brian and thanks, everyone for joining us this afternoon.
This past year was marked by progress on multiple fronts, but particularly for Emmy for a one our lead drug candidate as you May know Emmy for a one our pithree kinase Delta inhibitor is being developed to treat various b cell malignancies, as both a monotherapy and in combination with other therapeutics.
Yes.
It is currently in the phase two title IV study evaluating patients with relapsed or refractory for Liquidly lymphoma that is intended to support and accelerated approval marketing application with the FDA.
Before reviewing our achievements in the EMEA for a one program and providing some insights on what to expect in the coming quarters. Today. We are sharing the name issue to me for a one by the international Nonproprietary names or I NN programs, It's zand Delis Sip.
Zain detail I as I b.
Regarding our achievements this past year, perhaps chief among them is the global license development and commercialization agreement with key what Karen announced in April for the global development and commercialization of San Delis. It.
We see our agreement with key what Karen as validation of the potential for sand relative as a best in class Pithreek Delta inhibitor and key to broadly developing and commercializing it inside and outside the United States.
The alliance stems from our successful preexisting, Japan licensing agreement with Cuba, Karen and this grounded in our shared vision for the development and potential of then delis of as a new potential option for patients and their physicians to treat b cell malignancies.
Briefly as you may recall the transaction is a global development and commercialization agreement. It included a 100 million dollar upfront payment and up to 582.5 million in potential additional milestone payments.
If approved by the FDA in the United States EMEA and key work here and will co promotes in Dallas said with EMEA booking all revenue from sales.
Hi, and Q, a Karen will share us profits and costs, including development costs on a 50 50 basis.
Outside the U.S., Cuba care and has exclusive commercialization rights in books, all revenues from sales subs and Delaware.
Karen will pay EMEA escalating tiered royalties on ex U.S sales starting in the teens and it was responsible for all incremental ex us clinical development costs, and all ex us regulatory CMC and commercial costs.
Importantly, based on the shared vision for the potential of sand relative the company's incorporated into the deal and agreed upon development plan designed to broadly to evaluate San Delis IP in patients with various b cell malignancies, including in combination with other agents.
We believe this best optimize this the potential present relative per patients and provides value to our investors.
As an example of this shared vision I can announce today that we have filed an amendment to the title study to evaluate and relative as a monotherapy in patients with marginal zone lymphoma, who have received two prior lines of therapy.
We expect enrollment commenced by around year end.
Similar to our approach with the title study in third line Follicular lymphoma. We're also considering the accelerated approval pathway for third line marginal zone lymphoma indication if supported by the data.
I should point out that this new arm and the title study will not affect our plans to file on the molecular lymphoma patients. So if the data warrants such.
In additional in addition to expanding the potential utility Auvs and Delis IP as mentioned above EMEA I retain their right to book U.S sales, providing a foundation to extend the company's capabilities and build out our commercial capability.
Of course underlying this alignment and the Broadvision present relative is a strong and maturing dataset supporting best in class potential as a monotherapy and in combination with other therapeutics for the treatment of B cell malignancies.
Our most recent data update is from the ASCO 2020 virtual scientific program reported from our phase one be study in a total of 57 patients, including 36 patients with relapsed refractory Follicular lymphoma. This group of 57 patients is on the same sand relative treating.
And schedule being evaluated entitle that is once daily for 228 day cycles and after that daily dosing for seven days, followed by no therapy for 21 days in the following 28 day cycle.
The overall response rate in 36, Follicular lymphoma was 83%. The median duration of response was not yet reached in all follicular lymphoma patients and across all subsets analyzed the median follow up in all the molecular patient subsets was analog when analyzing thats about a year and it ranged from three months.
To 27 months.
Importantly, efficacy is only one part of the equation for assessing and drugs potential utility.
With Tolerability being the other.
The data presented demonstrated its end dellis.
Has been generally well tolerated and.
In this study and the incidence of efforts of special interests, which are historically associated with this class of drugs has been low with minimal increase toxicity observed over time in fact, no grade three or greater adverse events of special interests was it recorded after cycle three and the discontinued.
The discontinuation rate for any adverse event was only 7%.
We are in the process of preparing a publication of the data from the phase one be study and expect to have it submitted for peer review in the next several months.
Based on the data in the phase one be this past March we received fast track designation from the FDA fast track.
Products address serious conditions show some advantage over any available therapy to meet an unmet medical need and are eligible for certain regulatory considerations, including a rolling in da pre review process and often receive priority review if supported by the clinical data at the time of the NDA submission.
Now let me give you an update on the title study the global Phase two trial evaluating them dellis it.
As a monotherapy for the treatment of adults with relapse and refractory Follicular lymphoma. After failure of at least two prior systemic therapies, including chemotherapy and anti PD one antibody.
Approximately 120 patients will be enrolled their primary efficacy endpoint will be the rate of the objective response rate to therapy within the first six months of treatment secondary endpoints include duration of response and Tolerability of Zen Delis hub.
Subjects subject to the results upon completion of the title study we are planning to seek an accelerated approval present delis up by the FDA.
With respect to the impact of Cobot 19.
This pandemic that we're all facing on the title study, we were very proactive and successful to date in taking steps consistent with guidance from the FDA and other regulatory authorities to communicate with sites and investigators and in making accommodations to patients in order to maintain patients on study and preserve.
Of the overall integrity of the study.
With regards to enrollment as previously disclosed there was an impact and while the extended the impact remains subject to future developments currently our projections have us completing enrollment sometime in the first calendar quarter of 2021.
In Japan, Cuba, Karen is actively pursuing a clinical strategy analogous to the title study to support a Japanese approval, we look forward to providing updates on those efforts over the next few months.
Further we are currently in discussions with the FDA on the design of a global randomized phase three study in patients with.
Molecular and marginal zone lymphoma in combination with Rituximab that we look forward to initiating sometime mid 2021.
This study is intended to serve as a confirmatory study.
For tidal end da.
Under the accelerated approval pathway. It is also intended to support regulatory marketing approvals in other geographies.
Also ongoing.
As an arm in the phase one be study is the initial evaluation of San Delis of in combination with Santa Bruton, The Beijing BTK inhibitor under our clinical collaboration with that company.
Subject to delays also related to cope with 19, we expect to have an update on the combination sometime in the mid 2021.
The complete development effort to more fully explores andalus its potential across additional lines of treatment other that other diseases like CLL diffuse large b cell lymphoma, and mantle cell lymphoma, as well as in combinations with other agents like Rituximab and the Bcl two inhibitors.
Is even more expensive and we look forward to providing additional updates on these plans in the coming months as appropriate.
We believe that there remain important unmet medical needs across the B cell malignancy landscape for a potential best in class candidate likes and relative.
As a monotherapy and in combination with other treatments overall, we estimate the addressable market in these b cell malignancies represent roughly 50000 patients in the United States alone.
Given the broad opportunity the progress in this and Dallas Sip clinical program and the resources and Ics expertise gained in connection with the key work here at Alliance.
We have also actively gun to focus on the stage buildout of our commercial infrastructure to that end. This past year, we added strong commercialization expertise on our board of directors with the appointment of Sheryl Colin. This past April is Colin has more than 25 years in the industry with a focus on sales and commercialization income.
Leading as the Chief commercial officer at Medivation.
I'd now like to briefly update you on our other three pipeline programs.
Bruce a clip is our CDK inhibitor that we believe has potential to improve on existing treatments for b cell malignancies and to AML, particularly in combination with the Bcl two inhibitor fanatic clecs.
Bruce a clip as an orally available CDK inhibitor differentiated by potent inhibition of CDK nine in addition to CDK six four and one.
As well.
It inhibits Mick a well known transcription factor that is expressed at high levels and a significant proportion of human cancers.
Currently we are evaluating patients with hematologic malignancies in dose ranging us based phase one clinical trial designed to evaluate Bruce a clip dose and schedule before evaluating in combination with fanatic KLAX as might be expected. This program has been delayed by the pandemic and we now look forward to updating you.
On this program later next year.
Next to semi three four for our novel.
And tumor selective mitochondrial inhibitor targeting the Oxford less complex.
As you May recall, we presented clinical data demonstrating the ability of M 44 in combination with the anti angiogenic antibody vast and to reduce mean relative k. I 67 levels in tumors of women with Hertwo negative breast cancer compared to a control group of patients receiving avastin alone.
The next step for Amsthree 44, as an advisory board were convening later this year to consider our options that offer the most efficient path forward for the combination of M 44, and Angie antiangiogenic inhibition.
Including the potential for clinical collaborations we look forward to updating you as appropriate.
Now moving to our fourth clinical candidate percentage stat, and oral aged Akt inhibitor percentage that was licensed by any I'd say the health and group in 2016 as announced in July a phase three study a percentage stat and am out was terminated by health and based on our findings from an interim futility analysis.
Percentage that continues to be evaluated in a phase two trial in patients with high or very high risk Mds.
Helston has communicated to us that pending further evaluation patients currently enrolled in the phase two study are continuing treatment until they helston decides on the status of the overall program.
The program status as wholly within the realm of health SUNS rights under the license agreement and the future steps in the personal that program will be at Hilton's decision.
In sum fiscal 2020 was successful in advancing both keep us business and clinical objectives, particularly regarding our lead candidate Senn Delany.
Before opening the call to your questions I'd like to note some additional developments, including the appointment of Tomorrow House into our board at the beginning of fiscal 2019, Miss housing is a highly experienced business development executive with more than 30 years in the industry, including executive VP of corporate business development.
Lexicon, and senior VP of corporate and business development at BMS.
Finally, as Brian noted earlier, we significantly strengthened our cash position over the course of this year with the approximate 52 million from our December 2019 financing about 21 million in proceeds from our ATM facility and the upfront payment Karen we start this current.
School year with about $183 million.
Taking into account our current cash plus the approximate $20 million, we expect to receive sometime this year from the Japanese tax authorities.
That's about 203 million on a pro forma basis basis.
Which we believe provides a sufficient cash runway to see us through at least 2023.
In terms of upcoming milestones.
We expect most importantly completion of enrollment entitle and topline data.
The initiation of the marginal zone.
Arm entitle initiation of a phase two Japan study by key what Karen initiation of a confirmatory phase three study in Follicular lymphoma.
Then delis Evans and a bruton of combination data sand delis of NDS submission for accelerated approval in Follicular lymphoma.
Bruce a clip data from our ongoing studies.
Although while we build out our commercial infrastructure to be prepared for a potential as and dosing launch.
As is evidenced from our milestones just mentioned to maximize our success, we intend to primarily apply our resources, our efforts and our focus twos and elicit in order to fully optimized its potential to deliver benefits to patients and value to our investors, although while we explore the.
Potential utility of our other pipeline candidates.
With that update I think we're now ready for questions operator.
Thank you we will now begin the question and answer.
Your next question. Please press Star then one you touched on.
I wish you mean moved in the queue. Please pass the power side are there has to.
Have you using a speaker phone you many to pick up the had done first good question members. Once again if the question. Please press Star then one on your Touchtone phone.
We had our first question from.
Steven line is open.
Hey, good afternoon, thanks for taking the questions and.
Graphs on pretty productive quarter.
Dan just kind of curious so I think you you're now kind of speaking to completing enrollment in title.
First quarter.
21, I guess, where you stand right now.
What's the level of confidence in that estimate just kind of based on what the last few months of enrollment that look like.
And do you think that.
Leading enrollment in the first quarter of next year would allow you to kind of unblinded topline that trial for the end of calendar 21.
Sure Steve.
Yes so.
I'd say as we said last time or the.
Most recently when.
As we were running title our first and foremost goal was to open clinical sites around the world, which we kind of completed by December last year.
And then starting in the January early February type timeframe is when we started to see what we thought was a reproducible enrollment rate and then all that crashed obviously come March April may.
I'd say in the last two two and a half months the rate of enrollment has now come back to the same level it was pretty cobot and based on that.
And and sort of our projections on where we need to be on a monthly basis, I think we're pretty comfortable of saying first quarter now of course.
We'll have to see if the common situation gets worse than that will definitely could definitely impact.
And.
As we were sitting here right now I think we're pretty comfortable saying.
First quarter next year with that with the caveat took the cobot situation.
In terms of the data Theres really.
Because it is now a single arm. It was as you know it was two arms continuous versus intermittent schedule. So there's really no unblinding per se.
Once the last patient is treated as we mentioned that the response rate is the primary endpoint will be measured at six months. Following the last patient treated it takes about a month to get the data in.
So sometime in the fall, we expect to have kind of.
Topline data, whether it's completely clean at that point or not.
It is unclear we're going to work very hard to get the data clean through central radiology as we go.
And then of course.
We'll have to decide.
How we topline that data.
We don't want to do anything that would jeopardize the review by the FDA. So we will do our best to communicate.
Whatever information, we can at that time.
Whether its.
Expectation or what but.
We will do our best to convey some message.
Prior to the filing.
Understood and in many speak to the update.
In the San Bruno combination trial, I guess being kind of mid next year is.
Should we anticipate that.
That update to just include dose escalation data.
Or could there be a little bit of expansion cohort data within that within that update as well and I guess as you think about.
Future development program.
You've spoken to the inclusion of marginal zone. The confirmatory phase three I know part of the cure and attractiveness was that kind of really expand the clinical development program. So I guess.
How much more should we anticipate.
On top of some of the incremental.
Development plans that were announced.
Thanks.
Yes, sure Im sorry, I think I heard two questions, perhaps maybe I didn't I mean, the term specifically about the agenda.
[laughter].
Specifically with regard to than 10 Ibrutinib. We are now expanding in patient numbers. This was a us based only trial and so we were.
We were handicapped with Covidien, Unlike title, which is global and with so sites were coming in and out over that time I think that.
We are now in a position, where we will be able to have a lot more data coming in in the next many months.
And then we will move to these sort of cohort individual disease expansion arms.
[music].
As you can tell die our phase three strategy, we are striving to become to examine chemotherapy.
Lacking options, so San Bruno Rituximab.
Perhaps fanatic KLAX as well coming in the future.
But thats not to say that we aren't cognizant that there could be other potential applications in concert with chemotherapy. Although I think that has to be carefully weighed with the history of this of this class of drugs. So with there are other studies that we will plan on rolling out and hopefully in the near future.
And.
The big one clearly is completion with tidal and getting the phase three up and running those are the ones that are really are number one priorities as well is getting the marginal zone because that is a potential label expansion study as well.
I think thats five answers, but I'm not sure yes.
Thanks for taking my questions sure.
Our next question comes from.
Robin from Trust Securities.
Truest Hi, guys.
Oh, sorry, okay.
Alright.
You always have problems Dan.
Good question. That's your question on title burn.
No there's been a lot it within a few CRL lately that it may people a little despite.
Could you comment a little bit about when you do that conversation with the FDA what is the bar.
But what is the bar for the title that you think would be acceptable for the update to that we know that there might not be any pickup tolerate approval and then I have fallen.
Yes, Hi, Robert you can tell that I kind of.
Stumbled on the name as well, we just call exam like for San Diego right.
I think that so we are as I mentioned on the call. We are in conversation with the FDA about our phase three plans, which of course have to incorporate our experience with the drug and Tolerability and the fact that we're going into earlier lines Follicular lymphoma is of great interest in importance to the FDA.
Because of the history of this class of drugs. So they are well aware of our ongoing safety and efficacy.
Data, we do give them regular updates in conversation.
I don't there is no written regulation about this the Tolerability question that you raised but I mean clearly.
What we have said all along is that the drug needs to be tolerable sufficiently differentiated from the pack or it's not going to be commercially successful probably so I think that that has been why we focused our attention. So much on the Tolerability I mean.
It is and as the classes efficacious, we happened to think we are probably more efficacious, but we really have focused our energies and our discussions on that the safety aspect of it and of course title will tell.
If what we saw on phase one be is we'll read through to the to the registration package.
And.
I don't I can't say anything more about it right now because that trial is still running but I guess I mean I understand that the question and all I can say is that Tolerability is our number one focus and we keep our eye on it very carefully.
Great and then just two quick ones. So just for the publication can you just remind us big picture what additional data will be in the publication versus what you presented at ASCO, how much additional follow up.
To be in there and then on for any 30 or 44. Your CDK could you could talk a little bit about your thoughts on.
Would you partner that we could do a big global partnership when our would you just get strategic.
Yep, where you're getting drug from someone else's you're doing a combination trials so trying to figure out your strategy for the pipeline.
Yes.
Okay.
Sorry could you repeat the first when I got lost on the second half of your question I apologize.
For the phase one the publication.
Yes updated durability data what will be new data will be in there.
Right, Yes, sorry, thank you.
Yes, I think that did the ASCO date, I'm not exactly sure what the true cut off time was for that.
We will certainly have several more months there I don't believe there will be any new locations.
That were enrolled that weren't included NASSCO, perhaps there was one or two but I think that for the most part it will be just.
Longer follow up.
From what we were presented at the ASCO in the hot meetings.
With respect to 344 and Bruce a clip.
I think that.
We will go where the data tell US you know I think that part of the.
Having the resources now and.
Wanting to have the commercial capability building the commercial capability.
Puts us in the position, where we don't necessarily need to do large global partnerships in the future. Although we always look at at the numbers and if it makes more sense to do.
A larger deal or.
More focused regional deals.
It really just depends on where that what the nature of the trials arent and where the data takeout. So I really can't say, what our plan is right now, but certainly having.
Taking the.
The onus of building a commercial team makes us want to think a lot about how we would commercialized and develop future assets.
Alright, thanks, guys.
Our next question comes from Jim from Wells Fargo.
Yes.
Good afternoon.
Jim.
Next question on the pipeline.
And.
The.
This call these Glenn.
That's what we call it.
The protocol was amended set of around I think may.
At December 30 milligram dose.
Thanks.
Now that we're looking out.
Yes.
Yeah.
Why a study notwithstanding koby lines.
So slowly seeing very very careful.
How about that.
Dosing hands.
Sally.
Safety profile.
Whatevers cold now.
Then.
Disease.
Yes, yes, yes, it's a totally appropriate question Nick.
I think.
Certainly cobot has slowed us down there's no question about as I mentioned it to us based trial and mostly the larger institutions.
What we're really impacted by.
Having to deal with their own comment patient. So that is a problem I think that from the outset.
Our advisors had always suggested because they were most of them are involved in the early Pithreek Delta development with other agents. They were very cognizant of some of the problems that others had run into in doing their various combinations.
And they really preach to us to be careful and to take it slowly and make sure we get both dose and schedule correct. Because the the idea is that you may not need to have the.
Highest dose monotherapy dose needed for each of them individually in order to do the combination you may see that a synergistic effect, which are then of course reduce the potential for toxicity. So I think the real.
That is the crux of if it were going slowly and we're looking at schedule and dose.
In order to see to make sure we can come up with a combination that makes sense I mean, we definitely want to move into earlier lines of therapy and challenge chemotherapy as our as our goal and in order to go into earlier lines of of treatment, we need to be very clean. So I think that is the reasoning behind.
Or is the reason because why this this trial is moving slowly as in addition to being.
Affected by Cobot, it's sort of a two pronged, but it's mainly driven by our desire to make sure we're getting it right and not having.
Problems with the toxicity.
Okay. Thanks.
Sure.
Next question comes from Adam Evertts from ISI capital.
Great. Thanks for taking the question guys.
Just curious if you can give any additional color around the marginal zone lymphoma cohort on terms of expected number of patients and maybe how long that might take to enroll.
Right I think right now we're contemplating in the amendment of 60 patients. This is would be sort of an expansion of the our indolent lymphoma experience. So I think we're thinking about in that ballpark.
These are not as.
Available as flicking lymphoma patients are.
So in terms of.
How long it would take to enroll those additional 60 patients. If we started say year end.
I'm not I'm not quite comfortable saying right now until we we kind of get a sense from the sites that were working with sometimes these patients are silos and other clinical site and other clinical practices and sometimes there is depending on the sites that were going to we aren't going to take.
Into all the 100 or their thereabouts clinical sites around the world that we have so we're hopeful that will be a quick enrollment, but I just think it would be premature for me to give a projection just yet Adam until we know better on in terms of what the experiences with our clinical sites.
Fair enough appreciate that thank you.
Our next question comes from Yale Jen.
Some raimo and company.
Good afternoon and.
Taking the questions I, just want to fall off a little below the previous one in terms of modern those going.
Login to zoning 12 month.
Welcome.
Mono therapy or Youre.
Play, particularly at the combo as well would you use the same the recruitment or you will.
When you can get on there.
Yes, Hi, Yale Yes, great question, So I think I mentioned, it but if I didn't I apologize. So the plan is in the current amendment that will start shortly.
It to do monotherapy is exactly the same as title it will be the same schedule.
And it is in the third line as monotherapy.
In the confirmatory study.
With respect sand it will be both in Follicular and marginal zone.
For.
Full approvals.
Okay, Great maybe just one follow up.
In terms of idle it yes.
Yes.
Putting up a data in reporting that offline.
So many second half of next year.
You see that can get a lot.
For the AG would end of the.
Well, we'll certainly try.
I think I'd say.
[laughter].
Sure.
Our next question comes from.
And you.
On the H.C. Wainwright.
Yes, Paul Thank you for taking my questions I'll, just to Sudan, Logan Nathan and per Andrew.
So my first question was.
Regarding the confirmatory phase three study design, just kind of wanted to see.
What your thoughts were on that.
What kind of bar do you want that they will probably want to see on efficacy and.
Tolerability and also how many patients you may need for that put them to.
Hey, I feel comfortable with that study and then.
Secondly, kind of touching onto the operating expenses for the fiscal year 21, due to submit the enrollments being pushed into the first quarter 20 water.
Into later 2021 is there any changes in that.
I think that guidance basically.
Sure. So I think it would be premature since we are still talking to the FDA.
About the phase three confirmatory study with really talks and this will be a controlled study.
And so in terms of its not just Andre the primary endpoint will probably be.
PFS.
Of course, Tolerability is always going to be on their mind in as I mentioned in my comments. The history of this class of drugs suggested there potential tolerability issues. As you go up early we don't feel like that is the case, we have not seen that in our experience.
But our experience is of course is limited so in terms of Tolerability I really don't know what to say, but clearly.
Our expectation is our hope is that it will be as tolerable as is.
As what we've seen already.
In terms of operating expenses I mean, it doesn't it's not as significant push out it's not like more patients are more cost there is more CRL cost cuts.
The time is and but of course remember that all of our cost since April we've been sharing with Kieran Karen.
So in the two going forward basis, I don't think that.
Pushing out these timelines on the one quarter a timeline on.
On the title study is going to have a significant impact on our financials.
Alright, Thanks appreciate it.
Yes.
Our last question comes from.
Tom from BTG.
Hi, Thanks for taking my call.
So on the marginal sell cohort can you give us a sense of where you are with FDA volume that this is for accelerated approval or is that discussion part of the current phase three discussions.
[music].
Right. So for accelerated approval of course, it will always depend on the data and the available therapies at that time so.
You know if.
Looking at what has preceded us in other agents and other compounds.
We believe that Weve.
Designed the study sufficiently though it would can.
It would be.
Open for a discussion on accelerated approval, but.
Beyond that I'd be hesitant to say anything more.
They are very well aware of our plans.
They have not seen the amendment.
So we are we are proceeding along that path, but clearly.
As in any study for an accelerated approval it really.
The data will will drive the discussion more than anything else.
Dan.
Anything else.
Okay and then.
And kind of an open ended question on Bruce equip given the mix angle and how broadly mic is implicated.
Are you considering some sort of solid tumor basket trial is that compelling and any thoughts on target tumors.
Funny, you should ask that question Tom.
So yes, we are certainly that has not escaped our attention I should say I mean theres been interesting.
Preclinical discussions.
Several now.
Regarding the role of Mic expression in rast mutated tumors and not just that the GE 12 sees so that is something I mean, we know that Bruce a clear been preclinical studies is active in multiple different Ras mutated tumors.
Even in vivo studies or this is all preclinical.
So it is something that we are carefully thinking about as we as we look at the potential for this drug and we are doing some preclinical work around that.
To to see if theres the there there.
And I'm hopeful that within in the coming months or certainly sometime next year, we will have a lot more to say about that but certainly that is one of the attractiveness of Bruce a clip compared to those specific mcl. One inhibitors that are being developed develop that have no mick as Mick activity.
That Bruce a clip does based on its profile.
Alright, Thanks, I'll keep asking the question.
Okay Lucky given the same answer.
Okay.
There are no further questions at this time.
Okay, well, then wrap up I just want to thank you all again for joining us today.
I think we begin our new fiscal year in a very strong position with continuing a record of successful execution on our development programs in our business strategy.
We very much Oh look forward to reporting our progress to you across the entire portfolio in the coming quarters.
So with that I think we'll end the call and I just wish you all good health and please be safe where here masks.
Thank you ladies and gentlemen. This concludes today's conference. Thank you for participating you may now disconnect.