Q1 2020 Earnings Call
Good day welcome to the I'll know conference call to discuss financial results for the first quarter of 2020. Today's conference is being recorded before we begin. Please note that we'll be making certain forward looking statements on today's call.
Losing those restarting financial results statements forecast regarding anticipated timeline.
And expectations with respect to our regulatory and clinical development programs.
The other statements that relate to future events. These statements are based dumped beliefs and expectations of management as of today and actual results trends timelines and projections relating to our financial position and projected development programs.
And pipeline could differ materially in particular, there is never get uncertainty about the duration.
And severity of the Coven 19 pandemic its impact on comedy business and operations.
All investors to read carefully the risks and uncertainties disclosed in our filings with the FCC, including without limitation the various under the heading risk factors described in our annual report on form 20-F filed with the FCC.
And the risks and uncertainties included in the form 6K filed with the FCC earlier today Calmat assumes no obligation to outdoor up the any forward looking statements.
<unk>, which speak as of their respected <unk> only.
I would now like to turn the call over to Alan Sakharov.
President and Chief Executive Officer, Alan Please go ahead.
Thank you Shirley.
Morning, and thank you for joining us on todays call for example.
You see here today, you know what you've spent difficulties there will be up have you guys didn't meet.
Oh, Chief Medical Officer, probably go fine no cheaper natural p., so why should answer.
Your body wouldn't happen date in L. King.
Programs, it's worth it would report to you on all financial results for the first quartile Lucky.
It's always happy to take any questions you may have.
And it's all prepared remarks.
I'd also like to say I hope you with your family I'll say, well and work with walked away all the problems, but would not be outbreak.
I know what do you should we very much.
And shortly I will provide an update on its important alterations.
I'd like to share with you today, you predict pre clinical PK data.
I'm going to agree I see the drugs stops and if you call it could be evaluated our although not phase three study with our new formats are claims are important back.
But the last few years Diamond has been in the process when developing and you put that are important.
If you get some form of harmful fiasco.
No I'm, putting back I mean, our called I see you could they are called golf, which dropped from that you got me restricted.
Well, we could not.
So our cool you get to sit up do you feel are cool like ours or does it affect you.
That's very surprising results anyone given all the chemistry.
Based on these data we submitted in December 2015, Newport Beach, [laughter] protecting our own coming back I mean, it's wonderful watch wages are they're sold worldwide.
What people think Oh, I mean, it's compute and you kinda give entity.
That's good to other people for new chemical entity patent protection.
And it wouldn't be successful.
Thats what were written granted and heating thing 37, you were in territories in Japan, Australia, China, you Kinda, though.
Gosh I'm going to patent protection in the U.S.A., India and sibling how to do it expands our ongoing we got rid of impeccable pieces.
Yeah, I was talking about well think developing Oh patent protection for our cold what concern teams do you happen to foreign could see asking for the treatment effect could be.
I think was expiring keeps me before any potential hatch Waxman [laughter] extension.
No he's awesome to see that doesn't seem to my mother oral administration building, our called free I see an uncle melamine crossed over BK study dogs demonstrated bioequivalence would would use 40 ability.
Hello.
You can build administration you see our we have seen in the arm for making them almost identical.
The most people don't think Cityscapes, Hey, you see for the ARINC wouldn't like them in what Cardiocom, both the article free acid.
Major import does you did three for reduction in the course, you shouldn't valuation.
He's thinking I'm not going to be home arm could I see suggesting globally bloody among patients receiving are making them into the future do the major added value.
How flexible are cool wasn't restriction that both are and what I see that I'll come back I mean, he's I couldnt be cool you'd seen good a month they remain steady state.
To date that supports the stream, but in the ballpark for our I'm quoting on Quebec.
See mix was higher in uncle Magna mine births arm quickly I see steady state.
We plan to submit these results along with other support they ask you discussed today, if you assume it's a book to go.
Well corporately transition from our improved free assay.
I'm not going into ongoing AMOLED phase three study.
Based on all were going to things that you could give you.
The guidance for decades, our assessment is that due to change doing phase three be considered acceptably divided bioequivalence product gets published in a number of other considerations are addressed.
We have plenty to hold the coming by a future I know if they did discuss all because of this program.
I would like to move now we bought update I'll I'll move phase three study is what is to assess their volume impact public 19 for the first quarter.
And then you've already based company working on that disruptive event, it's almost like nature thought way of life.
No. So our long students watching the course different bonds and the required us to adopt remote work range men Prequaled 19. That's [laughter] then you had very little effect on our ability to maintain our ready operations.
Reaction to the rapidly evolving.
I think the safety population size practices, but they said in burdensome hospital system in accordance with the local restrictions that it would be nation, we decided to importantly, how meaningful new patients for Docomo study.
Well be Stein women, and an open and close communication <unk> clinical study sites and I'll note in the management of the study.
Do you see more reporting performers. So that's been on a regular basis. According to the local integration in the U.S. and other countries around the world ending with you must be the deep in the country by country stayed big states inside Lakeside Macy's.
Accordingly during Q2 Q2, we expect some constraints in stating the U.S. I didn't before I get reinstates, allowing you to be doing investigators.
I'm in what do you see would you wouldn't that be disease.
Where do you think the time you advanced approval in negotiation for additional insights new and existing countries.
You will allow us to minimize the wrong time false starts activation. So that you expect many sites would be ready for occupation wouldn't screening and randomization would be possible.
Our current assessment done by Q4.
We should be agent with unique crews men in many of our sites. Accordingly, we are moving old guidance for completion of recruitment of patients for the first part of the study since you do what do you spend one do you feel like anyone in reporting topline results for the first part of the study compute.
For what do you 20 due to the second Paul when you come to me.
Of course, dropping develop and Threed deal corporate banking endemic.
Any from must be made.
[laughter] disease, we have we never know most hobby lobby subject to change.
Hi, good cost over one you've taken ciber executing badger <unk> cost.
Minimize the old clinical related expenses, mostly to the ones that we tremendously to the money between the randomize patients.
It's communicated to help reduce in just the cold I was pleased but expenses directly correlated the patient enrollment and therefore, they then Goldman also would you don't catch burden on inpatient onboard in the study.
In addition, we made adjustments clinical stuff and they according to the current than predicted nibbling, <unk> and reduced reduce cash being bought by 50%.
It probably won't be.
I would like to take this opportunity you expressed towards since you brought that you'd almost investigators and the clinical teams who are going out of the way well boy I, you'll be early termination what it shrinks patient safety and should be in Fourq.
Before we open the call for you in a gun to cool.
To provide you with an overview for financial position at the end of Q1 <unk>. Thank you Alan and good morning, everyone.
I think it'll be providing you with off naturally votes.
I'll watch ended March 30.
Glenn.
Well, Michael My sharpening the pencil on important pump mondelez today would that be which among other things, but I can tell me about financial result.
[laughter] waterfield tolerance money or net loss totaled $6.1 million.
Well not extend for sure compared with the National 3.5, again I wouldn't think that's for sure but of course, playing well then consulting.
Research and development expenses like lung $6 million, that's one of them twice ones.
Average sleep on premium for the from what I was hoping you.
Increase resulted primarily from.
[laughter] when actually fell on going to almost nothing.
Our general and administrative expenses, what its water thought of zero point Ninemillion.
Okay, Yeah. Unfortunately.
You.
Increases often people have increased non cash stock based compensation expenses.
During the same offsetting ended March 31st itself and then playing out the next financial income or you don't like bought.
Persevere, one time Inc.
Water.
Our cash balance as of March 30.
Cash cash equivalents.
Sure well keep in mind.
Oh My God.
75.6 in December.
Thank you.
We got that operator, please provide instructions.
Watching how long haul.
Thank you.
To ask a question. Please press star one on your telephone keypad.
Confirmation to indicate your line is in the question.
You May proceed start to if he was a dream of your question from the Q.
Participants using speaker equipment.
Maybe necessary to pick up your handset before pressing let's start he's.
Our first question is from Yasmeen Rahimi with Roth capital. Please proceed.
Hi, This is <unk> on for yes.
Thank you for taking my question.
So two questions for you.
First is can you provide some color on health safety profile of Muslim in comparison arm cool.
Whether there's any completed long term Todd.
And to get clearance for phase three and what does he actually I mean.
Allow you to switch from.
Halted like <unk> and there's a follow up thank you.
Well. Thank you very question, we are building a worst case on compound that with the name of the basic tenets been done that.
So maybe you mean as it doesn't mean, we actually.
Uh huh.
Before I honestly, because like I said.
Let me.
It was approved in March 20 magazine, and I'm restarting all of your actually the cake supported by actually those compounds I consider staying active <unk>.
If the stipulation engines in plasma and Dr. somebody from both foreign interchangeable [laughter] cheap.
For.
Make meeting in this Oh, it took us ecology mezzanine and when published.
No. So is there anything any [laughter], calling G studies.
Based on the other cases, it's already use.
I mean as it comes online.
Okay. Thank you that's very helpful.
And a follow up question.
How many patients have been dose with ample and if you switched to make women well the dataset from I am calling they can they be combined and the final analysis. Thank you.
We're not disclosing this information I guess me then we win or once it was reached a milestone if we could find milestones will randomize patients would drill bits of information.
Hi, Thank you so much.
Our next question is from Steve.
With Raymond James Please proceed.
Yes, hi, Thank you interesting development.
Yes, I think I couldn't hear very well, but if you're just talking about the samit us.
On the precedent here for the Megalomaniacal.
And my understanding is.
The vendor maxims into kill sort of the free us another leg room insulted.
Actually dose differently on a.
Milligram basis, I don't know if that's because of the pharmacology, a fabulous or if there actually is sort of a question about interchangeability of.
Oh, the dose of the salt versus the free Osten. So I'm just wondering if again.
Although that is.
Is there a point of uncertainty about whether you can actually just swap in one for the other and keep the same dose or do you have to do so.
Dose finding work or even a multiple doses to the phase three.
Thank you see indicates that for me this does.
I see okay. Okay, no that's done well set by the way.
[laughter] 61 million around 80 milligram in making me.
[laughter] actually more lot different.
Yeah, I actually had one that is.
In knowing it just makes it more.
And could that.
Youre right with your I'm, sorry, Oh with your question.
The same had adjusting things those same Oh sounds administration and the same goes regimen as you do with generic the difference case.
Okay.
Okay. So following up there.
Yes.
If I could be for land is right. Yeah exposure. So you do you see there you see exposure it does and the amount of the complexity thinking the plasma off the patients not that's it does that you have given.
Okay.
A follow up to that would be Oh, let's give you an opportunity.
We'll go a return to once daily dosing or are you going to stick with the.
Dosing, but [noise].
Previously thought sort of switched to based on the PK study.
We would do every possible Wayne.
Cannot promise anything at this stage Oh, we are putting a lot of exports for the back then if it's not going to be.
In a as part of it wont be as the lifecycle management.
I think every effort and termination for that exact.
Method that you're actually asking.
Okay.
Could you just talk about the.
And the level of confidence in the non obviousness of the innovation step here on the legacy insult patentability of U.S. and he worries there because I noticed you mentioned.
Discussions regarding patent in the U.S. were ongoing with U.S.P. deal.
Yes, so I I see the number six on themselves that are they said Oh already 77 European country.
And Oh, Japan, Canada, Australia or old accepted that I mean, there's no question that doesn't make it surprises and when we compare.
I'll come back let me just sold Arlon mathematics, featuring a few didnt.
And so as you know absent a officers or are there or not independent and in some countries and taking a foster and how does it slow but we are highly confident a this is something got five fold.
I hope it a bit be solution Oh, the compound is a is not likely taken.
Okay. That's all you already know me [laughter] Yaki correcting me I said to me I was informed.
Really.
That's correct.
30003 below 30000 or some of it.
[laughter], Okay, that's a lot [laughter].
Last.
Let's just put a quick clarification question. So the press release, you mentioned that innovative step heres, what do and so.
New chemical entity pattern I, just because there's multiple terminology here I just want to.
Make sure I'm understanding that correct. So this is in fact that product, having or a composition of matter patent I'm not a formulation problem is that correct.
That's absolutely correct you can you composition of matter I think in fact, it might even be on an independent then I indeed.
It's a new chemical and budget is no gel formulation.
Alright, Thanks, a lot for the question.
Thanks to people.
Our next question is from Edward Nash with Canaccord Genuity. Please proceed.
Hello government and tape out I'm on for Edward today.
Congrats on the on the press release here and.
Steven Yasmeen got most of my question, but just one more for US because you had any more color around the current status of research sites worldwide on a regional basis like whether they're already opened but.
That's trying to seem so most of reopened and a related question is how are your approaching our planning for a second potential spike in cobot cases in the fall.
Let me start with the with the second question logistics and wave.
Interesting to you know.
We are running a global Bobby and its global study.
We get on a daily basis, you from five different continents.
And as you know I'm told you all worked very different dog waves and different timing different.
Countries and different region.
So we feel that some areas like Australia, we're very confident that are very few cases recorded.
Talk we and we feel that style strategy I would probably start recruiting very soon.
Hi, there already.
The the first wave and we recently had a very.
Successful, whether you know with our Korean investigating and they are eager to start recruiting patients. So I think Korea I would also be Oh, I see it stuck in a country I'll just talk.
When we open the ER, we currently and U.S. Ah you know because then we do.
<unk> fell homogeneous we'd need all the investigators we are getting a on a mix really on a daily basis requests from our investigators to our we opened their sites and and we are moving towards that and ER, we want to make sure so to God bless you need.
And also on if we are Oh, I would say yet convinced that yeah, there's no need to build that again for a second wave.
This is for you all are lessened.
Okay can you repeat your first question please.
Oh are you more or less faster that im answering my second question. So thank you very much for that.
Thank you.
Our next question is from Adam Wash.
So please proceed.
Hi team how are you I hope you're well couple of questions here I just wanted to be clear I was having difficulty with my connection I couldn't hear all that well Alan is there any chance that you'll have to restart the trial essentially what patients that the make we mean.
In other parts is there any chance it that the current for formulation is Ah.
I was going to have to be superseded by this one with a whole new set of patients.
So that's why maybe didn't get you think that's immediately it's a very good a precedent.
And day, they they've made a change during the study with a cross reference data from 103 I think.
And Ah there's no reason why you should not be able to do the same another.
Examples if you maybe a world eat dr., what's the theme a that they thought change so formulation amorphous skew a fixed the need a weekend.
And begin doing the we stop the study. So so these bonds are there are number one guidance it gave guidance.
And if you could be done no loss I'd say that he has been done before and the that's something you gave us an excellent very timely precedents because it was only approved in 2019 and as you know we you know you can access.
All the data both if you will P M and be a U.S., a and b a we like very much I'm of course, we had a consulting.
Regulatory a consultant that a week, we bought than we normally process before we decided to take these changes and so we feel comfortable that they'd be able to accept.
Uh huh.
That's helpful. And then you mentioned that you're going to have an analyst day in the coming months or we can potentially get clarity on some of these issues at the analyst day.
It seems that for the Michael I mean, there's a couple of things that are important to you. One is the you know the potential for U.S. patent and the other is the FDA sign off on potentially integrating the new formulation into the phase three are those would you expect both of those two are kinda pretty soon.
Indeed.
At the analyst day.
Or a in analyst day kind of independent of those two items.
Sure sure I've ever worked up what I want to correct ignore the new formulation anything new compounds. It's a new chemical entity. This is a very important change. This is a completely different patent protection.
And by the way that that submitted by that if I mean, it's a assay was approved in the phase three without the phase three.
Interesting they use the cross reference.
Cool referenced the data from me just like you mean.
And we outlined that phase three study they go and approval under 90 approval for so for me to me. So these are a this is an interesting poison pill spoken about would be cross referencing Plato.
We we are doing all this stuff you know copied not being of course here is there can disrupt it let me tell plans, because though I'm not sure when they would be able do a hadnt allow us to prevent that they saw and how long they oh I couldn't get every car.
So we wouldn't have to juggle between Oh of course beta and if we get from the FDA and our intention to provide additional information it's analyst day.
We will also like to discussing this I'm going to date, our pipeline products. So I hope that people would be done sooner rather than later, but it also depends as I said on.
Think of which we are not dependent them out like a FDIC responsiveness.
That's great and then just one final one Alan you know we've had data from other Nash companies are kinda coming out I Wonder if you.
You know you could maybe opine on kind of what you've learned about how arum call. A you know kind of stacks up and your thoughts on the space in general as it pertains to err on call. Thanks.
So I think Todd you wouldn't be more brokers person to do so our CMO Salix idea.
Okay. So indeed this week.
Had highlighted many questions weve nothing preparing for a long time.
What's disappointed with the Gen dissolved.
Hearing something no place to resolve.
I can't even one we are waiting for your information about potential contribution to the higher fees Lorraine.
Mhm who's not stuff, that's a weight loss came down to.
Syndication Sohu for example that this is not happy lifestyles.
And I think all boneless pathology for that's all you need so the only for more information the nice thing well be very very important pallbearer yield.
At the end of the day now consistent message people and the magnitude of effective message that in one study that's too there are some people right there but he.
That's exactly right thing that they generate whether it's I don't see improvements values with 91 basis point anything.
Well [laughter] right.
They're not having to do anything about double.
So cohen.
We Uh huh emphasize all of them.
At least that's fine.
Hi, this is highly important thing.
Yeah, the mechanism of action and clinical data to support minutes.
On both masses moves fast cycle.
Mike again.
Well, we emphasize that.
No need to go hand in hand, and hard desirable why not.
The animal studies their knowledge that.
Powered for though as one.
Adds to that population, which we hear a continued to.
Maintains that girl D. and we started this combination.
Exactly.
They should still holds together I think that we will learn from Oh.
Information that comes out.
I don't know that he and.
Well on track.
Good.
Great. Thank you.
Our next question is from Christian.
Scott with Cantor Fitzgerald. Please proceed.
Hi, everyone and thanks for taking my questions I hope that everyone at the gallon that team is doing well right now.
First question I had is are you able to discuss whether I P. What the topic that was asked about during your ongoing partnership discussions and how do you think this might change now that you know there's been some developments in the Nash space in General and also you may have extended I.P. here.
Thank you.
So so [noise].
Too early.
I I think I'd like to see more data coming from a from a this study from the.
Genfit study and clearly it's a there is a one less pain, we candidates in development.
But would you, which which I must say personally I feel very sad because that's when he is a that genesis has been volatile from my life.
A texas and for the patients and well.
Hi, everyone. We've been both can be savvy if of course, the but are we.
We always said you forget Mahler from one and has a mountain run.
As Bobby.
Before we.
We are planning the study as a robust knowing scobee, who meet both inbound and we keep on all a month product with things that are called is the best can do that the market.
So im going to treatment with much and I hope that that will give you a patent life.
That would remove or any overhang that was on a such a.
<unk>.
Okay. Thank you and do you anticipate to plan on planning or to discuss keeping the fast track designation status for that.
Its still early I mean, yeah no true, yes, then do something that's still for the regularly a consultant whether this is going to be independent I envy, Oh, we're going to Doug alone could they existing I and if it would be an independent I. Envy then yes of course, we go for the truck that.
Hi can be likely be that they crossed the ways to go through a type b meeting, but the type C meeting and up and continue the the development with the same I end.
So I won't be able to tell you when you have been guidance from basically.
Okay. Thank you and I know you haven't disclosed on number of patients that have been treated thus far but could you talk about whether you anticipate any challenges and if there any solutions at this time to collect follow up data from patients during these times.
Bobby.
Yeah, So actually I am I, saying, we are Uh huh.
I'm sorry.
That said he said not saying Hey thing HM two remain in the study [laughter] and Oh Wow, we allow let's see along with a line.
I'll now.
You know and taking a third guideline we feed that all our patients are ongoing and no formal offer far.
Let's see I know this is the area.
We are showing.
Okay. Thank you and then my last question here is intercept tentative FDIC I'd call, meaning its scheduled in two weeks from analysis I wanted to ask what you as a leap Steve Nash developmental company are on the look out for as it relates onto your own company program. Thank you.
I'm no true could you repeat the questions I'm not sure where he worked out you were asking.
Sure. So intercept AD com is scheduled to take place in a couple of weeks from now. So I was curious if you had any thoughts about whether there were any topics or questions you might you know.
Things could happen that you might think about as it relate to your own program you know so that down the line when you potentially filed for approval things that you might consider based off of what asked of intercept.
So unlike Q.
It seems that advisory board.
He just made the delay for a long time, and then asked field and we.
Now we have there.
Critical mile Oh magazines old I'm confident I pod exactly what is the required.
Or oh.
It's a special actually and we they always have time.
It was required one thing back in May.
This morning.
Okay. Thank you very much is very helpful.
Our next question is from Jason Mccarthy with Maxim Group. Please proceed.
Hi, everyone. It's a Dave on the line for a Jason Thanks for taking my questions I had a hope you guys are staying safe.
So I just wanted to see if you guys have any concerns about the new salt formulation of around call centrally exacerbating high blood pressure in patients with protection, especially given the fact that high blood pressure.
Potentially be a contributing factor to develop a batch thanks.
So thank you for that question, we have no such a sometimes the there's no there's no long life with friends family dollar quotas, they still rather.
Closed many times and [laughter] not one of them.
Okay that friendship clarification.
Our next question is from Ed.
With H.C. Wainwright. Please proceed.
Hi, everyone. Thanks for taking my questions.
And I'm very happy to hear that you are and have been.
Apparently addressing this long standing overhang of the of the short patent protection.
You and I Alan have talked about on numerous occasions in the past.
So ER.
I know this has already been touched upon by several questions previously, but just wanted to drill down a bit further clearly this is a new N C and your filing for a CMO or have pile the CMO patent.
My My question is you know you're clearly.
Confident on this path I guess, what my question is on the two key areas here with the F.D.A. in the U.S.P.T. ill.
What could potentially go wrong, what where are the key areas of risk where despite everything you've done today or there could be.
ER, either some disagreement or even just the delay on moving forward.
Thank you Ed So they you know it yes, and no question, because north or something but she's got shades of gray.
Oh for another formulation, whether this formulation can be accessed the same most it's about the.
Excellent okay.
I since whether its normal or not.
And the here, we had a very he knew.
Spaceman coming from a is depicting like I said before 37 independent fastened offices.
Which oh, hey, but he knew composition of matter Patrick in flying colors.
And discussions in the U.S., maybe a they are oh, it's longer or maybe down more prudent or but oh, we feel very good we have extremely good arguments.
And.
Almost set for us impossible been visas.
Let's see the B I think we love the accepted we are we yeah, we feel very strongly it all depends on what do you expect them. It's not the formulation that then it's a very strong new companies know metro something which nobody could expect but they did we.
And I'm sure.
No.
I don't see any risk in some of the program because we are.
And you can't seem to be transmission.
So we work on it we sometimes it's like a bit longer do I think granted.
But.
That would not change anything El pen.
Yeah.
Okay. Thanks for that or clarification. Another question, Eric I clarified and one other thing there is no development.
I mean.
Because people are important back let me and I'm quoting.
Good day. This is the same as our uncle.
So there's no.
There's no it's nothing different loyalty, which had some development in terms of they brought us itself.
And maybe just it's nice to add on their with Alan It's the same emphasis allowances or is very good and very well clarifies it.
Yes, I know, if you will see and that the validation process the or is that.
And you don't need any problem in the coming because there's other things that you see that into later because this compound.
Great. Thank you for that.
Oh.
So.
Another question is.
You know there there are couple Wow. This is a very similar compound of course is distinct and novel and there are two areas that you mentioned our different the.
The the higher steady state you we are you see all.
And a much higher solubility you mentioned before that.
Given given those attributes.
You will be.
Be trying every make every effort to try to see it for once daily dosing as possible.
Is there are there any other a specific benefits are attributes that you would look for.
But.
I would have been improvement over the data we've seen today with a radical.
Yeah [laughter] Christian Thanks for asking is when you have a compounds, which is glass for their just very is that likes variation in exposure among patients because it's not all of though so with I'm couldn't make looming that the main added value.
Reduction in quite fish since the very action I think said is that.
Exposure of older patients going to be quite similar and no very much varied from one patient to another.
Very good its very significant added value when you that from the city called exposure among patients is almost similar and not the bar.
And it gets a lot of how much an 80 when you make the on looking at the clinical data.
Great. That's a that's very helpful.
And then just one last question for me.
Are you know given your extended timeline here.
And certain degree or.
You know lack of visibility here at least in near term.
Do you or are you prepared to.
Or give us an estimate of your cash runway.
So it hasn't changed.
With skills the cost of the study.
So we already.
You're not going to increase because of these start change they will be some additional CMC cool, but this is budgeted and we are.
We keep the same burn rate.
With you.
Relatively small company. So we have a very managed burn rate.
And which is about a one by 1.5 million <unk> that up a quarter as you can see.
Are there additional cost for the CMC pool or.
Oh, the fixed burn rate that got additional cost for the CMC full well, we bearing or that you should know or I'm not going I mean, you already comforted to know budget.
Okay great.
Alan Thank you so much for this and congratulations on this.
On this developing to somewhat very much.
I very much look forward to your analyst day coming up.
We look forward. Thank you.
And our next question is from my Yank mentality with B. Riley. Please.
Please proceed.
Hi, Dan Thanks for taking my question then congrats on the progress.
Most of my question to address but I do have a couple of quick follow ups, though as you think about the process.
Engaging the agency and also.
What human studies I may have to do the D. N C. And then what's what's sort of process as it is it like a type C. Meeting you would have to have the dam like very similar to how you I think when through last year, but to be ideal versus Q to you that obviously you got to do the bio equivalence in drug drug interaction study could be.
Got you play.
That being said also I know for your India. You had these other Oh listed studies like about Big impediment nice balance de could be what what is the impact on that.
So the only thing that's we I kindly I'm doing this boy, it's going to Steven Newman.
And.
Yes can see this we are Holland the thing we will do we will try to.
To do our best.
Right.
Very good accumulation or few formulation, maybe allow reduction flown to do to VIP to QD not true this is going to be.
The boat.
We do need to stay within our and Youve seen within the exposure.
In order to be able to use all the doctor that is coming witness.
Mm toxicology.
And <unk> everything that's accumulates it that's fine.
We will stay within the range off the exposure.
The encore, it's the I.D.C. Hunter sneak on as it is in that now in a more.
So just to clarify a we are not aiming for higher exposure, we are keeping the same exposure.
Anyway, and philosophy generics are being developed and hence we would only need phase one bioequivalent study, there's no necessary, we don't need any other toxicology juncker interruption or any of these kind of study I must be the preclinical data and the phase one vehicle.
Although it's been member to stipulating active moiety, it's the same yet still talking about 16, they think Oh I'm, calling.
In the plasma and.
Everything that has to do with this.
At this point of view, it's the same active ingredients.
And could you got to say or the impact to other studies that are you started and I think while the study to help data by the end of the.
By the company.
So so they are the only studies that have a sobbing is one thing you are the a copy urban a which is ongoing and then.
So it's nothing could be impacted and either a phase one I'm not going to be impacted as well.
I think there must balance tabby. We've also it's one thing you know if they write your labeled a home phone. So it takes a bit younger and the rest of the studies.
Our our skills can some of them are delayed because of a copied magazine as best we don't think varies any oh, there's no urgency competing be studies show that how do I need it for indeed.
Great and then a follow up on phase three trial design have you disclosed or sort of your redemptions and also.
On this underlying or concomitant medications I I don't of course, you have to diabetics as a majority, but what are you allow English is what would what are you including in terms of.
Anti diabetic drugs.
Hmm.
[laughter].
[laughter].
Hi, Good question correct.
HM.
Happy that sort of color.
Feel to it.
More of these are the same topped the one but we have recently there was an exclusion criteria very meticulous and aligns with the FDA guidance that was out Oh, we allow.
He patient yeah, it's a stable or a different time find different times the racing depending on the driver.
Well sports the.
Only enroll stabilization based on their animals would be may want to see and other parameters.
So we we make sure that the patients at this time of MRM baseline are stable and on stays on the depiction no of course, we know that said the studies or lung study and patients may require I just meant for a change.
ER in there and then to patients I'm not going away the same for a that the person that other commodities hypertension, just keeping in west Texas. So all these standards of care adjustment, we acknowledge may happen during the study and we do not Oh.
Imposed and specific to allow month on ER, such a required changes.
ER or where are you done so that we are paying.
There are investigators to consider things attention and sometimes it starts with us but there is based on you know the we have no this alignment on [laughter].
Specific drugs for diabetes or are there some multi dispute.
And maybe you've asked because of drug drug interaction because of your previous so question. So I mean and all the learnings from the Genfit study into into placebo response, there and also the metabolic but I, but does not really showing that much of a defense drug versus placebo.
[laughter], though so we don't have yet.
ER densest hasn't it's close with her colleagues and communication.
He has a is related to this.
Well actually in the initial call the thing I say, hey, listen to it and they say that the first look they have done a indicate that's probably weight loss and sometimes can be region or not.
Possible for the finances people response rate.
I don't have more information than there are a you have on a this is true.
Great. Thanks, Thanks for taking my follow up question.
<unk>.
Uh huh.
Okay. Okay, I I don't always plan said with respect to bank drug interaction. We don't have the concerns with respect to either diabetes medications or ER since it was recession drug interaction.
That's great and looks like what is being.
Most of the data at the analyst.
Oh.
Thank you. Thank you.
[noise] [noise] and that concludes our <unk> session I would like to turn the conference back over to Mr. backer of for closing comments.
Thank you very much very so thank you all for joining our call today and a I wish you all there'll be a safe to stay safe and well and as always please do not hesitate to compensate us for any follow up question that you have.
Thank you bye bye.
Thank you. This does conclude today's conference you may disconnect. Your lines at this time and thank you for your participation.