Half Year 2020 Genfit SA Earnings Call (English)
At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone keypad. Please.
Please note that this conference is being recorded.
I will now turn the conference over to our host Stephanie Magner. Please go ahead.
Thank you and good afternoon, everyone. Thanks for joining us for the first half 2020 financial report in corporate update we just issued a press release, providing our first half financial update which also included details about our new corporate and strategic roadmap.
Press release can be accessed on our website at <unk> Dot com.
During our call, we'll be making forward looking statements as defined under the private Securities Litigation Reform Act of 1995 with respect to Gen <unk> expected future performance business prospects events clan.
Putting our new corporate strategy and objectives.
And the size of the market for PBC commercial certain t. within this market and the outcome of our lead a phase three study.
Study Oh, seven <unk> timeline for completion of the lead of trial timelines for the success of the commercial launch of a diagnostic test card by NIS four by our partner Labcorp.
[laughter] and benefits of corporate restructuring projects, putting a workforce reduction program, our ability to significantly reduce operating expenses.
The cash burn over the next several years and our ability to just the terms of our convertible bond.
These forward looking statements are based on assumptions that I Smith, Barney management, which although believed to be reasonable are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed or implied or projected by the forward looking statement.
For further discussion of the material risks and other important factors that could affect our business operations and financial results.
Please refer to those contained in our most recent filings with the FCC and I am a concluding our half year report available on our website.
These forward looking statements speak only as of the day of this webcast other than as required by applicable law. The company does not undertake any obligation to update or revise any forward looking information statements, whether as a result of new information future events or otherwise.
Joining me on this call is backup <unk>, our CEO phone.
Following the prepared remarks, we'll open up the call for questions that will be addressed by junket management. Please.
Please limit yourself to one initial question to allow time for others.
I now turn the call over to our CEO pocket approval.
Thank you Stephanie.
And good afternoon, everyone. Thanks for joining the discussion for <unk>.
A couple of webcast today is two fold first presenter conclusions are for work. We did following the announcement of Arizona based free resold to Nash and took only discuss how the results really final corporate strategy and how we see its implementation moving forward.
I spoke with key findings from an in depth analysis is carried out over the summer and look for ways. All the data set and what does this mean for Gen <unk>.
I will then shale new strategic vision for the future and hold you a map with translates into a new corporate structure and organization. Finally, I just got the financial implications of this plan and all that's your perspective at the end of this call you should have an understanding of what the coming years will look like for Genfit and then we'll be happy to.
Take a few questions.
No I will jump to a conclusion from a work on resolve it and the additional insights gained from a rigorous analysis, we've had on the full data set.
As a reminder, the first objective of his data review what to take an in depth look at the complete data set and then I just always findings as well as biomark evolution and assess whether there was justification to believe that the city could ultimately proves successful clinical outcome we.
We also wanted to explore the potential looked at a few Renault in sub population.
Although we did see evidence of activity, we did not see enough to justify continuing to study with a high probability of success.
Similarly, we have several positive trends and a stronger response in specific patient groups, but not significant enough to justify investing in a new development program.
Well, if they're gonna objective was to have a second day of curious conducted we've already know this but teligent we work.
We were committed to having a better understanding of this topic, because we realize how important it is for the old nice community to understand the implications into retail viability.
To date, a sufficient number of biopsies reread I've been perform which I'll. Let me suggest to me to objective. So complements the existing resulted dataset and in full by internal decision, making it took only address questions related to into read of liability.
I don't have a day all fighting equal both from gave me then study describing a paper recently published in the journal if the pathology, which concluded that this type of chemo reliability of he's a biopsy of innovation has implication for randomized clinical trial is it.
He is a context of Brazil that they kept their values were too low to draw any specific or new conclusion about the triarco and certainly nothing that we could use to support the subpart H approval.
The statistics only comes from but Intel <unk> Intel read of liabilities are really comes out and we look forward to discussing these findings along with the rest of where we thought we'd data.
With if D.A.M.D.M. yet moving.
Moving forward as stated by Elizabeth branch in an article from the same issue of a dramatically, but Oh Gee, we believe it will be important for this field to harmonize methodology is terminology is an expectation for trial.
The only additional analysis of the data Oh. This is going to tell me that resulted as reflected in the latest Nash development we.
We consider the FDA feedback regarding the Oba completed phase three Nash program as well as new data from several ongoing Nash programs and we should have confidence we made the right decision.
Indeed clinical trials is a nice base, all large long and very expensive considering the evolving national landscape and the results of yeah that is for a more complete dataset. We did some input cost to probability of success ratio was not acceptable to continue do you feel about the philosophy behind us and officially terminated resolve it.
In line with all earlier guidance in July.
Therefore, we are also stopping all clinical investigations related to a development in life cycle, well fit actually by doing that.
This includes combination studies pediatric studies and the study on leap its composition.
Now, let's talk about our new corporate strategy.
We are choosing to concentrate on two core drivers, but both address significant unmet medical need represents a significant business opportunity. It has a favorable risk profile. The clinical development of hit a few bono as a second line treatments in PBC and the development of all diagnostic franchise.
Let's start with PV or.
On September 20 for a few days ago, we announced the first patient visit you know and that's your phase three trial evaluating a few but I know in PBC.
This milestone is now behind us and we are recruiting patients we.
We have made the necessary adjustments in Croatia, we both general successfully executing this new cobiz well.
PVC price, that's exciting opportunities that are meaningful for patients and for corporate strategy.
To date, the PVC market, there's only one therapeutic option for second line therapy. After you this year.
Buckets is nearly $300 million every year with double digit growth.
The reason, we're so excited about this opportunity in PBC is that according to our market research the signaling PBC buckets could be over $1 billion in a few years.
There is only one approved product in single mine PBC and significant unmet medical needs remain.
We feel that there are a few bono if approved could be an exciting alternative for patients and if care professional.
Have you done from a phase two trial give us confidence going into if you had a two phase three trial, indeed, often to a 12 week you can see we've got a few bought all the composite endpoint was well above what has been required to get an approval in this indication.
A positive trend was also a seventh grader reinforcing of potential for differentiation if you.
If he gets it looks pretty good but what about safety well you know they are always surprises in clinical development, but we have thousands of patients with use of exposure to other people I know it has consistently demonstrated a very clean profile.
Finally, the commercial southern he is much higher for PBC, but he'd over LIBOR and metabolic diseases patients are easily identifiable always standards that said it is a clear treatment regimen and the customers are going to try to establish how do we know it's a more streamlined pricing and conversations.
In summary, we see a significant business opportunity in PBC. We're confident that we can have a successful phase three based on our phase two trial ever done and we will achieve its first patients. It is complete and factoring in the constraints of a pandemic, we anticipate phase three trial results by early 23.
Got a few bono has the potential to be a highly competitive signaling therapy with a very differentiated profile in a growing market estimated to be worth over 1 billion dollar by 20 to 25.
Noted move onto a diagnostic program this fall.
Oh, but he spoke program as you know began during the initial work we did on pre marketing quite a few Benoit notch.
Well market research highlight that a major challenge with Nash patient diagnosis and.
It also is a key question, which patients should be treated.
The emerging medical consensus of treating patients with the disease activity if at all and if I would say it's up at least if two men, but the biopsy would be necessary to provide evidence of disease stage.
But we know that these are expensive resource intensive and painful procedures. Furthermore, it might be the gold standard from a regulatory standpoint, but just simply not scalable in real life 2 million of free space.
It is therefore, a reason to us but for potential Nash market could be huge but it would never truly materialize unless the non invasive solution is develop but could easily be deployed at the large scale.
Since the barrier is determining determining if a given patient we diagnose Nash would be treated as opposed to simply diagnosed became with Nash, we launched the Nash diagnostic poor ground to address but one question does these patients have a treat nash, meaning fibrosis stage two above and.
The next day, which is cool off at least for now.
So as a diagnostic technology is a blood test that is as important because it will have to get it.
In the second half of 2020, the nice full program achieved two major milestones.
The first one what's a publication in balance that against for GE and if I told you the share of pivotal data, describing the validation process and performance of peaceful but.
Good day that showcase were robust and consistent performance took me school to identify patients with Nash it wholesale highlighted the performance of meaningful relative to other technologies, including commonly use liver fibrosis that.
The scientific publication is critical as it demonstrates that the school is not just a simple and scalable solution. It is also a high performance solutions that looks at both components of Nash and can aid in identification and therefore management of patients that are treated.
The second milestone was on September 28, two days ago or the announcement of an exclusive license agreement with Labcorp to commercialize a novel diagnostic test for Nash forward, they only small technology, which is.
It is a meaningful step for at least for the book that we have a large scale commercial loans, but important progression from a previous collaboration with Labcorp Covance, which focus on the clinical research environment.
These four technology will not be made broadly available to the public and start addressing the diagnostic needs of millions of individuals that are free of progressing too low.
Progressing through late stage complication of Nash.
Luncheon is anticipated in early 2021, and we're looking forward to seeing that cokes and successfully commercialize it solution.
The financial terms of the agreement Evan didn't exclude it but we do expect revenue in Virginia. So.
Yes, I think agreement is momentous compared to the existing agreement in which the cocoa processing thing you saw in the clinical research setting.
As a reminder, the scope of initial agreement was to provide a solution for sponsor whos running clinical trials in Nash.
The gold companies about recruiting Nash patients screened candidates with biopsies and the screen failure rates is often close to 70% but.
That is a lot of useless biopsies unnecessary pain and the risk to patients as well as significant waste of money, that's close to $5000 or both.
By using these floors or prescreening tool sponsors have been able to drastically reduce the number of screen failures, but expediting recruitment and saving both time and money as well as better predicting patient.
It is a very positive response, we got from several major pharma companies and biotech firms, but confirmed the usefulness of needs for it.
It also helped build deeper on the partnerships and pave the way for a broader launch of peaceful.
Although we do think that the Nash diagnostic markets, we had a really take off with the availability of the first Nash drugs or market research suggests that there is already an unmet need for lunch.
So launching these four commercially now makes sense as it will aid physician and the millions of patients, including many pre diabetic diabetes overweight and obese patients will benefit from a diagnostic of atrophy that we've.
We have a diagnosis as care professional we'd be more notes for any co morbidities money, so disease progression and patients can be empowered to make healthier personal choices today. So I just thought I'd.
As stated by patients in a focus group, sometimes a diagnosis can be a powerful motivator.
In summary, we see a significant business opportunity, we have at least for diagnostic and a partner Labcorp is about to launch and make it available broadly.
Simple and cost effective way NIS four addresses key unmet needs of millions of patients and can be seen as a first step in taking control of the disease.
So we have clearly identified two clinical program priorities, but it will be the pillars of our development PBC and diesel but as we execute our strategy we need a structure that is fit for purpose and sustainable but from a human capital and financial perspective, So let's start with the structure.
First when we look at those two main programs, we see little synergies in terms of business model, both CPI and partnership opportunities financing or regulatory environment.
It's always a diagnostic it actually brought on PBC is a shot fertig NIS four lines with a large national market and retail why PBC is an orphan disease, we must focus on specialty care. So due to the limited overlap in disease. She Jensen tenant we've decided to create two separate entities to host this corporate programs with independent teams.
Corporate branding for Joe listed parent company will operate to ensure that the potential of each subsidiary is well recognized.
They are free tangible benefits that will result from this decision.
The commercial side two organizations, we support more partnership opportunities there are certain pharmaceutical organization, some of whom I've already expressed interest in co development of specific needs for base development, but it will be better able to create and execute partnership outside of a domain and jealousies organization.
Second this would improve operational excellence by having more specialization I believe.
Our ability to execute flawlessly is important and streamlining and focusing operation we'll have to do it and finally, we also think it will provide more value to stockholders as we believe it will allow for better visibility and understanding of our diagnostic business.
Let me provide a few more detail starting with the diagnostic entity. So at inception, the diagnostic entity it will be primarily but not entirely focused on Nash diagnostic it will I said north entirely because it will also leverage our accumulated knowledge and networking nusz and it would carry forward valuable tools for that.
In development as part of a much effort for us.
Example, gensets has indicated resource to utilize artificial intelligence to address the current challenges biopsy read it.
Also as a result of Lifelock in Nash, we have accumulated a plethora of data that we believe can be leverage for value, adding outpatient services.
The new diagnostic company. We'll also continue development of an exciting portfolio of products that extend beyond this fall.
One of the key need that exists in the Nashville is for example, the ability to monitor disease progression a solution that will be essential for health care professionals based on and also payers.
The another need is the ability to identify with granularity specific sub population of Nash patients.
With that would be used for especially for company launching a product in Nash, but they are targeting a population that is a very specific stage of the disease and we got a help them identify those patients.
For the drug NTT pretty straightforward it will initially be focusing on accelerating the execution of our PBC program, but of course going forward. It will also be the vehicle to develop a new molecules or additional indication for the future.
Let's now talk about our financial perspective, starting with key aspect of the house 2020 result, so.
So firstly cash position is at 226 million euros as of June Thirtyth. This was 277 million.
As of December 31st 19.
Secondly, operating income is 5.9 million was 5.4 million as of June Thirtyth 19.
19.
But comes essentially from a research.
He suspects credit, which amounted to $5.2 million for the first half of 2020 was $5.3 million or preceding half year.
And then the operating expenses were 55 million and they were 51.3 million.
Same time last year.
About two thirds of it is R&D expenses.
The increase in operating expenses is due to increase in marketing and pre marketing expenses, obviously marketing and pre marketing commercialization expenses will significantly decrease into the second half of 2020 due to the discontinuation of a pre commercialization work for you if you're running Nash following the termination of this program into.
Right.
General and administrative expenses and research and development expenses decreased slightly between 2019 and 2020.
These expenses will progressively decreased further as of the second half of 2020 following the company's decision to begin the process of terminating the clinical trial for the if you want to be Nash.
And 70 dating secondary programs as well as executing the cost saving plan I'm going to tell a little bit more later.
They don't.
As a result of changes in revenues and expenses. The net loss amounted to 53 million as of June Thirtyth 2020. This is 51.1 million last year. The net loss for the full year 2019 with $65.1 million or all of that in Europe.
Further information is Chris described is a full consolidated financial statements as well as such as three Auditor's report on the consolidated financial statements that are included in the appendices to a 2020 has your business and financial report and also available on the investors page of adjusted website.
So let me now provide a little bit more color as to what you might expect going forward I start by saying the company recognizes the need to rethink our financial strategy in light of our new reality, following very solid results and broader implication.
Specifically, we need to drastically reduce operating expenses and prepare for sure by restructuring of that.
As mentioned earlier, we decided to terminate all studies related to the launch of it if you're running Nash. We also immediately terminated activities related to pre marketing and launch preparation from supply chain over which market access.
We then conducted a full review of all of our R&D programs and terminated all projects, which were no longer directly relevant to supporting or two corporate priority specific.
Specifically, we stopped all ror gamma program as well as several preclinical projects, which were deemed a lower probability of success and provided less value to shareholders.
The program, which remains under investigation beyond the corporate priorities. We already discussed is and is that Nash fibrosis, which is still being evaluated in an investigator led proof of concept study focused on high both and the future of this program will be decided once data is available.
We are streamlining support functions to align to our new smaller footprint and following this symmetric review of operating expenses we are.
Eliminating all non essential span from also the satellite office in Paris to our attendance and sponsorship of Congress to just give a few examples.
Anything on the cost savings, we have initiated a workforce reduction program.
Restructuring plan that would aim to reduce our total employee footprint from over 200 before the announcement of our phase three result to less than 125 by year end. So that's roughly a 40% reduction.
So what is the net net effects of those initiatives. So in terms of cash burn we work writing, it's an annual cash burn of approximately 110 million euros annually.
Annually before the resolve it announcement. This included the cost of risk for the trial and all associated activities related to launch readiness.
We expect these efforts that I just described to allow us to reduce the cash burn to approximately 45 million annually for 22 and beyond however, the reduction will not be fully realized in 2021, why because resolve is a large and complex trial weve along financial window, mainly due to the better.
Though some regulatory and administrative processes involved.
Current estimates for closing and full termination of resolve it.
Approximately 25 million us dollars and therefore, the cash consumption related to resolve it will extend well into 2021 so.
These projections remain estimates based on reasonable assumptions, but they are subject to change.
So now that we've reset our corporate strategy have clear priorities and.
While aligning of structure and cash burn accordingly, we need to also address of that so to that end Jensen plan to propose to convertible bondholders and shareholders an adjustment of the terms of the convertible bonds. The company's objective is to begin this process towards the end of the year in order to have a balance sheet, which is true.
Third in line with new strategy.
I will conclude by saying that gen feet does readjusted its strategy in light of our analysis of the data generated in on Nash phase three trial.
We've built on our strengths and we are confident in this plan that focuses on the development of philosophy by knowing PBC and the commercial launch of needs for both.
Both programs as promising potential for PBC, we see a clear regulatory and commercial pathway to significant market and we see this fall as a key enabler of the Nash market, but yes, it's changing which we have a medical need is really huge and in dire need of solution.
We are streamlining organizational structure to focus on operational excellence and specialization in both BBCN diagnostic Ben.
By reducing our workforce workforce by roughly 40% and our cash burn by over 50%, we are creating a lean and agile organization, but he's a line we will revise cooperates ambitions.
We noted forward to providing additional updates in the coming months on the developments of our program and the implementation of its new corporate strategy. Thank.
Thank you for joining us today, we appreciate your ongoing support of Genfit and with that I'd like to thank you for your attention.
And let me turn the call over to the operator for QNX Okay.
Operator.
Thank you.
Begin our question and answer session if you.
If you would like to ask a question. Please press star.
Star one on your telephone keypad.
A confirmation tunnel indicate that your line is in the question queue.
You May press Star Starkey, followed by the number two to remove yourself from the question queue.
Once again to ask a question press star one on your telephone keypad.
Our first question comes from Tom.
Thomas Smith with SVB Leerink. Please state your question.
Hey, guys. Thanks for taking the questions.
I have a few I guess, let me start with the phase three PBC trial.
Can you give us a little color around the rationale for the L. fiber nor dose selection and the phase three and I guess, what went into the decision to move forward with only 80 make dose level.
Yeah sure.
Thanks, Tom Hey, Hi, how are you doing.
So I have here Weve me Dean Didnt have as you all know or two cents, because VSOE and COO.
And I will let him home, but that question.
So Tom Thanks for the question and.
Thanks for that question I think we have to come back to the results of our phase two trial, so remember to phase two trial Clarence.
Clearly show efficacy of our fiber NRE.
Not only on the out on the primary endpoint alkaline phosphatase phase, but also hitting.
Positively with high significance on on a composite endpoint and that composite endpoint was.
What was the one that was used as a surrogate endpoint for registration at the current second line.
Therapy, but also the same endpoint, which is being used in.
In our pivotal phase three trial, okay. So remember the phase two was run at two doses to your point 80, and 120 and you saw as when we presented data at EASL on 2019 that hit on those endpoints, but also hit on.
Various different markers and there was data showing.
As for where we see a trend on courageous, okay, well pipe in our had a trend to be beneficial one providers. So at those two doses of 18 120, we consistently see equally potent activity across the different markers and across the different endpoints I get there there were some slight differences but.
We think that those differences or related to.
Slight differences in baseline, but having said that clearly equal potency between the two doses and when you consider that.
We decided to go with a single dose wishes to 80 milligram dose.
There is no other reason.
We as not realizing the way nuclear receptors work.
I think what you.
What you want to do is find a dose we get Max fall activity and not go much beyond that to avoid any.
Off target effects and so what that's not to say that there were we saw any issues. We did not see any safety or talks issues consistent with all the other trials with our pipeline are up to date.
So because of that youve been potency that we see between the two doses, we decided to go with the 80.
Got it okay. Thanks, Dean for that for that color I guess also in looking on on Clin trials I got it looks like there's a requirement for paired liver biopsy unless that is one of the inclusion criteria can you talk a little bit about this requirement you know whats the something FDA explicitly ask for its.
So we.
Why did they ask for that and then also.
It also be helpful to hear your perspective around what kind of impact do you think this could have on enrollment.
Yeah. So Tom another very good question. So yes. This was a request from the.
The FDA however, just to be clear and there are two points, yes, it's a request from the FDA, but it is apparent from our interactions and discussions from the FDA that this requirement is first of all not specific to our five an hour.
And it's also important to realize that in our.
Ongoing discussions with them. It is also apparent that the FDA is currently requesting liver biopsies.
In the context of our pivotal PV.
PBC trials okay.
The main reason for this is a to be able to assess the safety of different drugs developed in PBC. Okay.
However, having said that I think it's important to note although.
Although this was not a specific request for our five an hour and the main reason it is based on safety, but remember Ella five nor has very clean safety profile.
I have not seen any safety or tox signals whatsoever throughout the different trials, which has been conducted but also keep in mind out of all the trials. We run up to date, we realized I think everyone realizes that we have a large expenses safety database and.
And again, the totality of the safety database in the case of five an arts way well tolerated with no specific safety concerns. Okay. Another important point is that we also have a lot of data coming out of the resolve II trial, which is the phase three trial.
In Nash.
And if you think about biopsy because remember in the Nash trial was 120 milligrams were going to PBC with 80 milligrams, but even with 20 120 milligrams in the Nash trial after treating patients for semi two weeks we have.
Yeah, obviously use from over 900 patients in that trial and when you look at the biopsy I mean, it's totally clean there is no indication of any interface any problems of interface hepatitis or any other safety signal. So I think with such a large database and now with this additional data coming from the biopsies and then ask.
Trial of course, what we'll be looking to do.
Is to go back and continue our discussions with the FDA because it's also clear that the the agencies thinking regarding the design of clinical trials. In PBC is also evolving so I think it's important for us to continue to have this dialogue with them. The other part of your question, whether and how this will have an impact.
On the recruitment of the patients yeah, I mean, I think well have to realize you know and everyone knows that biopsy is not standard of care in PBC, but having said that.
What we're finding from discussions with many investigators is that once they realize the profile Vela five and are based on the efficacy EPS was a safety profile as we have shown in our phase two trial the the investigators by and large most of them are very motivated to offer this.
To their patients and the context of our phase three and as we all know the motivation of the investigators play a big role.
For the patient to get enrolled into a trial so.
Is that make it a little bit more difficult. Yes. However, we are cognizant of that and and as we continue our discussions with the FDA, we are going to work hard to make.
Make sure that we addressed that.
Matt as much as possible and so I think we just have to get ahead of that and continue our discussions with the agency.
Okay. Okay.
Okay. Thanks for the for the color I guess just quickly turning to the next for diagnostic and the agreement with lab core.
Can you just walk us through.
Exactly how I guess, you and and Labcorp plan to commercialize the product I mean, what what steps need to be completed to gain regulatory approval in the U.S. and then what's the strategy for driving adoption and reimbursement of the diagnostic.
So I'm going to take this one.
So first of all we don't need additional regulatory approval so noise.
Surely surely marketing so labcorp is going to take that that marketing effort.
We anticipate that they're going to launch early into next year and when I say launch it's really their salesforce is going to offer.
This diagnostic to all of their customers in the us.
First at least.
And essentially what we're going to do.
He is also help them and try.
And try to generate that interest in into the market as I was saying earlier from a pure commercial standpoint. It is.
It is clear that the.
President and the launch of a of a drug.
Would really sort of.
Immediately make the need for for diagnostic very acute however, the market research we have it but obviously we've shared with Labcorp is that these already.
Already.
Need to be fulfilled because.
Because it has some value to know whether you are at three Nash and it can be approval enabler for four patient as well as some.
As well as.
Healthcare professionals, so labcorp will enroll for marketing market access also working to get this test reimbursed in the U.S. and we'll then.
Although we do not disclose the financial terms.
Because that sets that can probably see what we can say is that it's a fairly standard licensing deal with like an upfront.
Milestone payments and a royalty as.
That's linked to talk to the sales revenue so that.
So, but that's how it's going to open ended we are really excited.
To to see what happens.
Okay.
Great. Thanks appreciate the additional color thanks for taking the questions.
Sure you're welcome.
Okay.
Our next question comes from Derrick our channel with Stifel. Please state your question.
Hey, guys and thanks for taking the question just Q1.
The study and then one on five and our more broadly so just on the estimated timing for.
Study results I think you said 2023 can you give us a sense of how much buffer isn't there are coded but also how much you're allowing for additional time because of the biopsy requirement.
The second one on the study would be just around the cost and understanding your cash position. I mean are you able to fully fund. This trial through results based on the current cash you talked about and cost reduction plan and then lastly kind of the broad thinking of five more now.
Looking at other indications Mechanistically, where do you think you can play with this molecule and beyond our fiber nor would you look to in license additional assets into the portfolio. Thanks.
Alright. Thanks. Thanks for this question all interesting.
So.
The first one was.
Related to.
The.
Yes, okay.
Yes sure. So initially our vision was that we would need one year for recruitment and as you can see from from the guidance. We've given we are basically as added about six months.
Sticking into Q2.
Taking into account fee.
The Cobi constraint.
As the as we go through a biopsy as as Dean mentioned that two things. So first of all right now we we feel that the initial enthusiasm is not.
I mean is compensating I guess four falls, we fulfill burden of three of the biopsy and going forward and we hope relatively soon we hope that the that that requirement will change based on ongoing discussion with the FDA and the sharing of the of the data that.
Dan alluded to.
With regard to the the the cost.
In FY <unk> as.
As I mentioned in the inventories there are two elements right. One element is the cost cutting measures. The other one is we're restructuring of the debt.
If we do those two things then.
Then yes, we.
We are we are financing to to result, but of course, we need vets refinancing of a dead because of maturity of on currently is.
Okay, well go 22, which is before the.
The expected results.
Regarding your last question I will.
I will let Jim comment on on where we can go Mechanistically Weve, we should assume until we go through in licensing I would just say, we'll be open to an opportunity, but obviously.
We also.
Focusing on cash towards those two core Grimes, so anything we do would have to be.
Sort of.
Cash neutral right.
So Jim do you want to comment on fee.
Yeah Okay.
So I.
I think what's important to keep in mind is that the mechanism of action of our fiber nor is the dual agonist, which is activating both per hour offend people at Delta and remember in the past.
In the past, we still we spoken quite extensively that our five an hour.
Clear evidence that it is activating and hitting on both people are often Cooper Delta what does that mean is that this provides a perfect clarity potent activity, meaning that as the two nuclear receptor activator works in revenue.
Front pathways and what that leads to is different.
Beneficial activities when we.
Look at our data and the different trials and including the phase three trial, we see it at our pipe in or does.
Does have different activities, we see the effect on different inflammation markers as well as different metabolic per.
Parameters and so on so thats very potent activity there.
So when you think about our five an hour in PBC I think this cleared paulson activity comes and plan to bear on on the.
Use and the potential benefit that we expect to see.
You see patients in the context of our phase three.
There are other indications, where our five an hour through that mechanism has strong potential to provide some benefit one that comes to mind is PSC. This is something that's on our radar.
We haven't made a decision there yet, but thats one that said potentially interesting for four out of five and our so I would say you know what it started some of the things we're thinking about that.
That other call as Patty diseases and.
And I know before anyone asked the question in order book combination therapy and things like that I mean, these are things, we continue to think about but realizing that.
Nash space is not a simple and easy straightforward space to move forward and however.
Yes.
That that that possibility is there.
Great excellent. Thanks for the color guys and congrats on the progress.
Our next question comes from Ed Arce with H.C. Wainwright. Please state your question.
Hello, everyone. This is Thomas Yip, asking a couple of questions for.
So first for the new or the two new entities.
Can you elaborate for us some some of the.
The opportunity is there sort of a Terry partnerships for the next for the Speaker program and what's your consumer spending all the Nash Astec subsidiary at some point.
Well, yes. Thanks, Thanks for the question and so I think at this point, it's premature we're still early in that process. We have all legal team are looking at different options.
We do noise that we want to have as separate entities because.
Because we feel it will really as I said enable a number of things and the partnership is an important is an important one.
The agenda for today is.
Always about the value creation for shareholders and by doing this we think we can really.
Achieve it.
When we say partnership in in diagnostic, which we have specifically in mind is.
A number of companies are not going to go after the entire Nash.
Market trades going to target the specific patients.
The issue of how do you identify this patient is always going to be critical and of course, all nice patient look the same.
And they feel feel the same even having a symptom.
Because we have a solution that look at both the activity of the disease and the fibrosis were able to.
Almost tailor.
All I'd tool weve, great granularity to a specific patients who we could develop.
A specific 82 for anybody wanting to target the specific patient of course, it's a little bit difficult for those companies to try.
Truly partner and engage with us if they also see us as a potential competitor.
And that's why by having a sort of separate entity developing that.
Part of the business, we feel is going to be a lot easier and then of course as the notion of of speciation driving operational excellence today, we have a number of personnel that are working on both the.
The drug and the diagnostic so sometimes are competing priorities you need to sort of re adjust to a new new reality when you move from project a to two project B.
You know, it's sort of DNA, sometimes we tend to have a prioritized drug development. So that's why we felt.
By by doing this.
Separation, we would create a lot of value.
On the diagnostic side, obviously, but also also on the voice side.
Because no it's all going to be a matter of operational excellence to get to those results as quickly as possible and execute on recruitment for example.
So we need to get all mine fully fully aligned we've had that objective.
Okay sector, because so much for allowing the rationale for ARCC and your acetate is perhaps a quick one for the phase three pivotal study or should we expect any data point from the US under review with our impairment analysis.
Yeah, I mean, the SMB will be put in place I think it's reasonable.
Okay.
Reports or guidance from the SMB back.
However, there is no interim look on efficacy.
There's just safety efficacy.
Okay.
Thanks for clarification finally, one one short one.
National question.
At this point can you tell us roughly what will the restructuring charges to be in the next 12 months.
Restructuring charges.
From memory.
Yes.
Let me get back to you on this I don't want to.
A number in mind, but.
I don't want to say something wrong.
Something wrong, but we can we'll we'll find out and get back to you on this one.
Sure. Thanks sure thing.
Thank you so much for taking my questions and we look forward to the progress on this four and the businesses study.
Sure.
Our next question comes from just Meacham with Bank of America. Please state your question.
Hey, guys, it's Aspen on Jeff Thanks for taking my question.
So maybe taking a step back and think you make a little bit longer term.
So when that within the context of this new restructuring plan.
Maybe you could talk about some long term.
Plans for your pipeline and maybe some maybe maybe a timeline for earlier.
Earlier stage assets, something like that and TV program.
When when we could see that moving through the clinic and when we might like.
Some corner data.
Thanks.
So I will I will let you elaborate.
Dean, but with regards to a proof of concept I think we're expecting data.
Q1 next year so.
So of course, we will decide on the show Fad of that program when when we have when we have that data.
Volaris.
Did you want to.
Yeah, I mean for for NT said there.
There is that the proof of concept thats going on but Tom as as we are.
Studying more about anti said looking at potential primary targets and so on we're learning quite a bit.
About this this drug candidate.
We will be coming out with with some.
Public.
Guidance on unresolved, which we are are finding right now, but clearly it's interesting because when we started and T. said this is coming from the field extreme and one advantage of doing a phenotypic screen is that you're able to.
Defy potential drug candidates, which work through different mechanisms, which is not necessarily dependent on a single primary target.
And our one hypothesis, we had was that fibrosis remember we're targeting fibrosis with it does that is that fibrosis is could be one of those things where you get good efficacy by hitting on different primary targets working through different pathways and so on and so as we're looking for these primary targets. This is actually.
Pairing to be the case, where we are coming up with different mechanisms multiple mechanisms and multiple primary targets and we and when you look into that I think there are other potential indications for NT said, which were considering not ready for prime time, yet, but we plan to be working through some of those.
Yes, so above and beyond the readout on the proof.
Proof of concept trial ongoing now I think there are other possibilities for for Ensign said moving forward.
The other thing I would like to add from a pipeline standpoint, so on Monday.
Im diagnostic right right.
Right now we have a tool that is essentially identifies patients weve addressed Nash.
But we have a number of R&D program ongoing one is trying to develop a way to monitor disease progression, which we believe is going to be absolutely key going forward because in a disease, where you have no symptoms.
Payers are going to want to know with whatever they are paying for four is actually working so monitoring. These progression is important first one axis of research and as I mentioned the other one is developing specific I'd to tailor made to specific specific.
Compound based on on.
Demand from differ.
Different sponsors all people willing to to launch in Nash. So those are the.
Areas, we are currently.
Currently working on from a from a diagnostic standpoint.
Thank you alright, well.
Go ahead.
Thank you all for your questions well close the Q and a portion of the call now and I'll hand back call back to back out pre John for closing remarks.
All right. Thank you all for joining US today, we are thankful for our team. We appreciate your ongoing support of Genfit during FY transitional period, as we implement our new corporate strategy have a great day.
All parties may disconnect.