Full Year 2023 Inventiva SA Earnings Call
Yeah.
Good day, and thank you for standing by welcome to that incentive annual which shows Twenty-twenty Suite conference call. At this time all participants are in a listen only mode. After the speaker's presentation, there will be a question and answer session.
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Glenn Please go ahead.
Thank you good morning, good afternoon, everybody and thanks for joining us today for this webcast.
Before we begin as usual I'll ask you to please read the disclaimer on slide two which should appear now and I want to remind everyone that various statements that we may make.
During today's conference or during the Q&A session will include forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995.
Today in this call I'm joined by Joe Shockley, our CFO and by our CFO and co founder of Jetblue.
So let me go back to some of the highlights of.
Let me she burner development program like <unk>.
Starting by an 83 so in January 23, we announced some important changes to the design of the phase III.
The waiting learning in patients with Nash Nash, which made the study by retroactive for the cycles, and especially more patient friendly.
The new design is based on discussion we had with the FDA. The alternative approach put forward by the U S. FDA, which includes two independent phase III.
Well based on historical outcomes, making three which would allow us if our readout are positive to fight for accelerated approval in the second phase III study in patient with much less a competition with cirrhosis, which would be our confirmation trial in order to demonstrate he can.
Clinical outcome outcomes.
Which would securities positive full approval.
As part of the development of lending we were pleased that our partner single by your firm received their ILD approval by the Chinese and MTA to initiate the clinical development in China.
Unknown Executive: is participating in our Global Native 3 Phase 3 clinical trial, and we have closed 2023 with the first patient enrolled in China and also a breakthrough therapy designation granted by the NMPA in China, making Lanny the first drug candidate, to our knowledge, to receive such designation from both the FDA and the NMPA for the treatment of MASH. We also published the results, the positive results of a study conducted by Professor Cusi from the University of Florida. 2003-2023.
As you know by your firm is participating through our global Lithia three phase III clinical trial.
We have close to 723 with the first patient enrolled in China.
It also had breakthrough therapy designation granted by the NPA in China.
Making money the first drug candidate to our knowledge to receive such designation from both the F. D. A N DNA P. Eight for the treatment of mashed Nash.
We also published the results the positive results of a study conducted by professor <unk> from the University of Florida in 2003 and 2023.
Unknown Executive: The study met its primary endpoint, which demonstrated the reduction of intrahepatic triglyceride in patients with MFLD, NMFLD, and type 2 diabetes treated with a low dose of Lani for six months. What was key in this study? showing the effect on hepatic fat and liver and muscle insulin sensitivity as well as fat metabolism within just 24 hours. The effect on insulin sensitivity is an important feature and key differentiator of LANI versus other therapies approved or in development in NASH as insulin resistance is the main feature of all NASTs. We have also been active in licensing, and we have announced the licensing of Lani in Japan and South Korea with the signature of an agreement with Palace Farm. This is an exciting milestone and expands our potential footprint. With this agreement, we have received a 10 million increase in payment and have exercised our right to take a stake ownership in the newly created company. In February, we reported the first SUSAR ever experienced with Lani, and this as we were approaching the end of our screening for NATO. Our team has been an ease, all hands on deck.
The study met its primary endpoint, which demonstrated the reduction of wind Tre Patrick triglycerides in patients with muscle.
<unk> in type two diabetes treat it with a low dose of <unk> for six months.
It was key in the study.
Doing the effect on the tactic fat in liver and muscle insulin sensitivity as well as fat metabolism within just 24 weeks.
The effect on insulin sensitivity is an important feature.
Key differentiator of lending versus the older therapies approved or in development in Nash as insulin resistance. The Fisher feature award less patients.
We have also been active licensing as.
We also announced the licensing of planning in Japan, and South Korea with the signature of an agreement with <unk> pharma.
This is an exciting milestone and expands our potential footprints.
This agreement, we have received a $10 million upfront payment.
At the size of our rights to take a stake ownership in the newly created company.
Okay.
In February we reported the first sundar ever experience with Lonnie.
And we said we were approaching the end of our screening for late Q3.
Our team has been and is all hands on deck.
Unknown Executive: We have made the changes to our protocol as recommended by our data monitoring committee, and we're today back on track. We have resumed screening, and also we have started randomizing new patients at the majority of our sites under Central ERRB in the US.
We have made the changes to our protocol at a recommended by our data monitoring committee and work to date backup the truck we have resumed screening and also we have started the randomized in new patients in the majority of our site under centrally or being the U S.
Unknown Executive: And we confirm that we target Nash patient first visit in the first half of 2020. Finally, just last week, we announced the positive interim analysis of our proof-of-concept phase two clinical trial legend, evaluating the combination of NANI with SGLT2 inhibitor and budget flows.
And we confirm that with target less special further visit in first half of 2004.
Finally, just last week, we announced the positive interim analysis.
Our proof of concept phase II clinical trial legend.
Evaluating the combination of not only with <unk> two inhibitor a budget flows.
Unknown Executive: The study was designed to potentially demonstrate an additive effect of the combination and the management of weight gain that can be observed in some patients treated with Lanifex. This study met its primary end point, which was the reduction of HbA1c, and demonstrated that the combination addresses a moderate and metabolically healthy weight gain seen in some patients. The study showed that Lani alone and in combination with Empa induce a redistribution of fat from visceral to subcutaneous fat, reflecting a shift from pro-inflammatory visceral fat toward metabolically healthy adipose fat.
The study was designed to potentially demonstrate an additive effect of the combination and the management of weight gain that can be observed in some patients treated with Lendingtree Bernard.
The study met its primary endpoint, which was the reduction of HBA when C and demonstrated that the combination addresses the moderator metabolic iezzi weight gain seen in some patients.
The study showed that both lonnie alone and in combination with <unk>.
User registered mutual of fat from diesel to subcutaneous fat, reflecting a shift from pro inflammatory disorder fat towards medical the metabolically LC adipose tissue.
Unknown Executive: This redistribution of fat is consistent with improved insulin sensitivity seen with both Lanny alone or in combination. Finally, Lany improved markers of cardiometabolic health. The effect size appears to be further improved when Lany is combined with. These results further bolster our robust data set, our faith-to-be native, from the Investor Initiative Study conducted by Professor Luzi.
If the redistribution of fat is consistent with improved insulin sensitivity.
Seen with both plenty alone or the combination.
Finally landing improved markers of.
Cardio metabolic effects.
The effects site appears to be further improve when <unk> is combined with them.
These results further bolster our robust data.
Our fish to be native.
From the Investor Initiative study conducted by <unk>.
Unknown Executive: Don't give up. Don't be afraid of the future. Plan ahead. Dress the disease from off the body.
Professor Uzi.
David.
Blood threatening disease from of muscle.
Unknown Executive: We plan to present this data at scientific congresses as well as submit it for comment. We'll briefly cover several key financial milestones before turning it over to Jean. In 2023, we secured financing of approximately $39 million. We also have secured $50 million of non-dilutive financing from our partner in China following the progress made.
We plan to present these data at scientific Congresses, as well submitted for publication.
I will briefly cover several key financial milestone before turning it over to Joe.
In 2023, we have secured a financing of approximately $39 million.
With the equity issuance, we also secure a 15 million dollar or non dilutive.
If a partner in China following the progress made in the <unk>.
Unknown Executive: Development of Lani, and then an additional $10 million with the signature of the licensing agreement with Ipales Pharma, which also makes us eligible for up to $231 million in clinical, regulatory, and commercial milestones, as well as Royal. And also, as you are aware, at the beginning of the year, thanks to the achievement of key financial and operational milestones, we drew the second tranche of the 50 million. EIB alone, we're in the second tranche world of 25 million.
Development of learning.
Joe: And then an additional $10 million with a seek later.
Joe: Sensing agreement with <unk> pharma, which also make us eligible up to 2000 231 million dollar of clinical regulatory and commercial milestones as well as erosion.
Joe: And also as you are aware.
Joe: At the beginning of the year.
Joe: Thanks to the achievement of key financial and operational milestone, we drew the second tranche of the <unk>.
Joe: $50 million.
Joe: Euro.
Joe: Hi.
Joe: <unk> alone we are in.
Unknown Executive: We are very optimistic about the future of Lanish Fibonacci and Inventiva and are focusing on the upcoming important milestone, which is for us, the last patient, the first visit to the phase 3 clinical trial, which we expect to secure by the first half of this year. Let me give you some figures that make us confident that we can achieve this target. We have more than 75% of the patients targeted to be randomized in the main cohort, and more than 350 are on screen. Importantly, close to 90% of all the patients randomized come from North America and the EU, which we think bodes well for the quality of the results. From a financial standpoint, we are, of course, focusing our efforts to expand our cash runway, and we are confident that the recent positive data from Legend, the progress made in 83, and the approval of Resmetterum with no requirement of biopsy for prescribing the drug create a favorable environment for investment. The management of patients with NASH-MASH will require treatment options and potential combination therapy, and we certainly think that given Lanyfibranor's dataset and mechanism of action, there is a significant space for a neural drug with a direct antifibrotic activity and a strong insulin sensitizer like Lanyfibranor.
Joe: The second tranche will those $25 million.
Joe: We are very optimistic for the future of <unk> and in the Diva that now.
Joe: Focusing on the upcoming important milestone.
Joe: Which is for us the last patient first visit to phases phase III <unk> III clinical trial, which we expect to secure by the first step of this year.
Joe: Let me give you some figures that make us confident that we can achieve that target.
We have more than 75% of the patient targeted to be randomized into the main cohort.
Joe: And more than 350 are in screening.
Joe: Importantly, close to 90%.
Joe: This patient for the patient randomized come from North America.
Joe: <unk>, which we think bodes well for the quality of their results.
Joe: From a financial standpoint.
Joe: Sure.
Joe: I said that we are of course, focusing of our efforts to expand our cash runway.
Joe: We're confident that the recent positive data from legend the progress made in India.
Joe: And the approval of risk meta room with no requirement of biopsy.
Joe: Scribe into drug create a favorable environment for even deeper.
Joe: The management of patients with Nash mesh will require treatment option and potential combination therapy, and we certainly think that given lendingtree Bernard data set the mechanism of action. There is a significant space for our neuro drug with a direct anti fibrotic activity and strong insolent sensitizing likes.
Jean Volatier: This was clearly highlighted in the recent physician survey we conducted in the U.S., showing prescribers expect to write lines in Fibonacci for approximately 30% of their time. We now turn it over to Jean, who will provide you with an overview of our full year 23 financial report. Thank you, Frederic. Good morning, good afternoon, everyone.
Joe: Like any fever.
Joe: Because clearly highlighted in the recent physician survey, we conducted in the U S.
Joe: Growing prescriber expect to write new fibrillar for approximately 30% of their bias patient.
Joe: We'll now turn it over to Joe who will provide you with an overview of our full year 'twenty three financial reports.
Thank you Fredrik good morning, good afternoon, everyone.
Jean Volatier: So everything has been said, I must say, and the financials for 23 reflect quite rich activities, as you have heard. Let's start with the profit and loss accounts. So the company's revenues for this year amounted to $17.5 million, I guess a record for Inventiva since it was created, and an increase by more than 40 percent compared to the $12.2 million recorded in 2022. As I said, revenues derived from two things. First, the continuing milestones, two milestones from CCTQ Sinopio Farm, the Chinese partner, for $5 million. And also for two-thirds of these revenues in 2023 from the milestone, the upfront payment of $10,000 million from Nepalis, and also a non-cash consideration from the fair value of an option to acquire shares of the JV.
Joe: Everything has been said MSA and financials for 'twenty, three which Blake equate, which activities you have ever heard.
Joe: Let's start with the profit and loss accounts. So the companies are revenues 40 share amounted to $17 5 million.
Joe: Our record ever for <unk> since it had been created so an increased by more than 40% compared to the $12 2 million recorded in 'twenty two.
Joe: I said the revenues derived from two things first.
Joe: The continuing continued continuing milestones to my teams from <unk> and hope you found the Chinese partner.
Joe: $5 million and also for the two thirds of the data.
Joe: Revenues in 2003 from the milestone the upfront sorry, the upfront payment of 10000, Mi 10000 million dollars from that.
Joe: For me, please and also a noncash consideration from the fair value.
Jean Volatier: The key thing is, of course, the increasing effort in R&D, so an increase of 82%, reaching 110 million in 23 compared to 60.5 million in 22. Obviously, this reflects the planned acceleration in the 23 activities with regard to the clinical development for Native 3 and also to a lesser extent with the Legend Phase 2a combination trial we have just talked about. G&A expenses amounted to $13.8 million, a slight increase of 7% compared to $12.9 million in 2022.
Joe: Have an option to quest shares of the JV.
Joe: The key thing is of course, increasing our efforts in R&D, So an increase of 82%, reaching a $110 million.
Joe: In 2003 compared to <unk> 5 million in 'twenty two obviously this reflects the.
Joe: The acceleration planned acceleration in the 'twenty two activities with regard to the clinical development for 93.
Joe: And also in a lesser extent with Allegiant phase II combination trial, we have just talked about.
Joe: G&A.
Joe: <unk> amounted to $13 8 million.
Joe: A slight increase of 7% compared to two to $12 9 million in 'twenty two.
Jean Volatier: We consider it to be rather under control, considering the growing scope of the activities of the company. To be outlined also, a net financial income of 5.1 million, a loss which reflects, we've talked about the EIB first tranche in 2023, with interest rates which would be paid, I remind you, end of 26, early 27, but of course, we incur the expense related to this loan and also the interest that we pay on the other existing minor loans. The variation in net financial income is also due to close to zero foreign exchange results in 2023 compared to a greater positive result in 2022; this is obviously related to the euro-dollar context in 2023 compared to last year. We recorded for the first year our share of net loss for the stake we have in Epalis in the Japanese JV with a non-cash loss of 12 million, of course, compared to zero in 2022, and all things considered, the company's net loss for the full year reached 110.4 million compared to 54.3 million in 2022.
Joe: We consider its return to control.
Joe: During the growing scope of activities of the company.
Joe: To be outlined also a net financial income of <unk>.
Joe: Five 1 million loss, which reflect a we've talked about the EIB.
Joe: The first tranche.
Joe: In 'twenty three with interest rates.
Joe: Which would be paid I remind that.
Joe: And a 26 27 and of course, we incur the expense related to these two these are known and also completed by some interest that we pay.
Joe: For the other existing miner loons.
Joe: The variation in net financial income and also due to close to zero.
Joe: Foreign exchange results in 23 compared to <unk>.
None: Great to have positive results.
None: In 22 this is obviously related to the.
The euro dollar.
None: Context intent in 'twenty, three compared to last year.
None: We record for the first year.
None: Our share of net loss for the stake we have in a police in the Japanese JV.
None: The non cash loss of 12 million cost compared to zero in 'twenty, two and all things considered the company's net loss.
None: For the full year <unk> reached a 110 4 million compared to $54 3 million in 'twenty two.
Jean Volatier: Let's talk now about cash. If we consider what we call a global cash position, including the pure cash and cash equivalents, the middle-term investments we have that are very liquid and easily mobilizable, and the second tranche of the European Investment Bank that we drew in mid-January, we started the year with close to 61 million in cash compared to 88.4 million at the beginning of the prior year. So it's a decrease of close to 30 million. Obviously, it reflects the higher cash consumed by the operations, 82 million, including, by the way, the 20 million cash in, definitely deriving from the effort in R&D. By the way, in terms of metrics for R&D, we must underline that L'année Fibra Nord is really focused on our financial efforts. R&D in the company represents 87% of overall expenses.
None: Let's talk now about our cash.
None: If we consider we what we call our global cash position, you know, including the the pure cash and cash equivalents.
None: I mean, there Tim.
None: But are there.
None: They're illiquid and easily.
None: There might be legible.
None: And the second tranche of the European investment Bank that we do.
In mid January we started the year with close to 61 million in cash compared to $88 four at the beginning of the of the prior year. So it is a decrease of close to $30 million.
None: Obviously, it's a it reflects the higher.
None: Cash consumed at the operations $82 million, including by the way the 20 million cash in.
None: Definitely deriving from the.
None: Efforts in the R&D.
None: Either way in terms of metrics for the R&D.
None: We must underline that.
None: Many people I know, it's really focused in our financial results.
None: R&D in the company represents 87% of overall expense.
Jean Volatier: Of this R&D, of this 87%, L'année Fibra Nord represents 85% of this R&D expense. And overall, for the company, 75% of our financial efforts are dedicated to this program. So, the negative impact, of course, of the operating cash flow has been partially offset by the operation that Frederic mentioned. First, at the end of August, the finance rate of 35.7% growth in regular capital increased.
None: These R&D of this 87% learning people are now represent 85% of this R&D expense and overall for the company seven.
None: 75%.
None: Our financial efforts.
None: Dedicated to this program.
None: So the negative impact of course of the opioids.
None: Operating cash flow has been partially offset by the operation that phonetic.
None: I reminded firsthand over guests the finance rates of $35 seven gross.
None: In regular capital increase.
None: Foster such an increase we we got the support from existing partners, such as AR, especially Nova and Yanked capital and also with very pleased to welcome.
Jean Volatier: For such an increase, we got the support from existing partners, such as Sofinova and Young. And also, we are very pleased to welcome Qatar Holding LLC, who now holds close to 10% of our shareholder base. The negative operating expense has also been offset, as mentioned, by the $10 million upfront payment from EpaDIS and the $5 million related to the two milestones reached with CTTQ, the first patient randomized, and the attainment of the IND. Overall, our cash position as of today, we do confirm that this will allow Inventiva to operate until early Q3-24. I will be glad to answer any questions in the Q&A session if needed. I just pass over to Frederic for the conclusion. Thank you. Thank you, Jean.
None: Holding LLC, who now all the close to 10% of our shareholder base.
None: Then you get the Virginia operating expense has been also set as mentioned by the $10 million.
None: Upon payment from <unk> and $5 million related to the two milestones reached with GTT to first patient randomized and the attention of the Ames, Although all our cash position as of today, we do confirm that this will allow <unk> to operate until early <unk>.
None: Q3 24.
None: And we'd be glad to answer any questions in the Q&A session. If needed just specify too to predict for the for the conclusion. Thank you.
Thank you Ralph talk if we move to the conclusion, let's open it up for the Q&A I see that there are.
None: So the question.
None: Randy.
Randy: Thank you.
None: To ask a question. Please press star one one on your telephone and wait for your name to be announced.
None: The waste of your question. Please press star one on one again.
We will now take the first question.
Operator: Before we move to the conclusion, let's open it up for the Q&A. I see that there are... questions. Thank you. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To restore your question, please press star 1 on 1 again.
Speaker Change: Come in line of San Juan Fernandez from Guggenheim Securities. Please go ahead.
Speaker Change: Oh, thanks, so much for the question so.
Speaker Change: Fredrik I just wanted to.
Speaker Change: A follow up on some of the data that was just presented and comments from.
Seamus Christopher Fernandez: We will now take the first question, coming on the line from Seamus Fernandez from Guggenheim Securities. Please go ahead. Oh, thanks so much for the question. So, you know, Frederic, I just wanted to follow up on some of the data that was just presented and comments from Dr. Harrison on the call that were certainly very interesting. You know, we've got the ResMedAram data, not a lot of changes that we see in HbA1c in a diabetic patient population, whereas, you know, we very clearly see substantial changes in HbA1c with Lanny, and then also the incremental benefits of adding an SGLT2 would suggest that, you know, this opportunity is quite substantial. Just wanted to confirm your view of the market, his comments that he would much prefer to give his product to or give this product to diabetic patients, and then also just the confirmation that, depending on the timing of the completion of the last patient, when you would strongly expect this to be the next oral mash therapy available in the market. And I have one additional follow-up question. Thank you. Thank you, Seamus.
Speaker Change: Dr. Harrison on the call that we're certainly very interesting we've got the resin that around data not a lot of changes that we see in HBA one fee.
In a diabetic patient population, whereas we very clearly see.
Speaker Change: Substantial changes in HBA, one C with money.
Speaker Change: And then also the incremental benefits of adding <unk> two would suggest that.
Speaker Change: The opportunity is quite substantial.
Speaker Change: Just wanted to confirm your view of the market. His comments that he would much prefer to give his product to our give this product to a diabetic.
Speaker Change: Patients.
Speaker Change: And then also just the confirmation that.
Speaker Change: Depending on the timing of the completion of last patient.
Speaker Change: When if you would strongly expect us to be the next.
Speaker Change: Oral Ms therapy.
Speaker Change: Available in the market and I have one additional follow up questions.
None: Thank you. Thank you Seamus, yes, I wish we were actually very pleased by the comment made by Steve Harrison who said.
None: <unk>.
None: <unk> will be approved if you see the patients entering is clinique with mesh in type two diabetes.
None: It was prescribed journey over any other compounds.
None: Let's see.
None: That's for us with a very nice comment because.
None: We know that.
Frederic Cren: Yes, I wish we were actually very pleased by the comment made by Steve Harrison, who said that for him, once Lanny will be approved, if you see the patient entering his clinic, he would prescribe LAMY over any other compound is ESC. And that's, for us, it's a very nice comment because... We know that there is a large proportion of patients with Nash and type 2 diabetes, you know, between 40 to 50; we have 60% in our phase three study without, you know, looking to recruit more patients with type 2 diabetes. And this patient with type 2 diabetes actually has a form of Nash that is more severe. You tend to have a higher proportion of patients with F2A3, and they also tend to have more progressive fibrosis.
None: There is a large proportion of patients.
None: With Nash and type two diabetes between 40 to 50, we are 60% in our phase III study without.
None: Looking.
None: To recruit more patients with type two diabetes and this patient with type two diabetes actually.
None: At a form of Nash, which is more severe they tend to have a higher proportion of patient with us two or three nodes, where they tend to have a more progressive fibrosis. So that was one.
None: Great and when we look at.
None: The competitors, we're really seeing that.
None: TVT on HBA when see the influence sensitivities broker is that we have that we're.
None: We're clearly illustrated by the study we did with <unk>, where we saw.
None: Statistical impact on insulin sensitivity and delivered the muscle.
None: Really a feature we really want to put forward.
Frederic Cren: So that was great. And when we look at our competitors, We really think that this activity on HbA1c, the insulin sensitivity properties that we have, that were clearly illustrated by the study we did with Professor Cusi, where we saw a statistical impact on insulin sensitivity in the liver and the muscle, really a feature that we really want to put forward and really work on stressing the importance of these properties. And we should also not forget one piece of work that we did, where we saw that patients with predia So it's really a compound, Lani, that has a great profile for patients with type 2 diabetes and also, & Co. And then to your question about whether we think we are the next oral approved drug. Yes, I can confirm that because I am.
None: We work on.
None: The importance of.
None: All of these properties.
None: And you should note also.
None: Not forget one when a piece of work that we did.
None: Where we saw that.
None: Patients with pre diabetes treated in the phase two b so their diabetes stopped their progression towards that it stopped when treated with <unk> 43.
None: <unk> a compound that is a great.
Profile proficient state of diabetes and also.
None: Pre diabetes and then to your question about.
Do we think we are the next already approved drug yes.
None: Confirm that because I.
None: We are.
None: Close to finish the recruitment.
None: Right.
None: The first half of 2006, the other oral drug that we know could.
None: Could be.
None: <unk> met that.
None: As to start phase III is the older drive in development and the phase III are injectables.
None: All the studies that we have done.
None: We spent years and especially prescriber really put oral drug as a preferred.
None: Administration, most vessel versus Injectables. So I think we're very well positioned in this field.
Great and just as a follow up question as it relates to the phase III.
None: You commented that.
None: I think you've already kind of add.
Abbott and a further 5%.
Frederic Cren: I'm close to finishing the recruitment, and I'm studying the first half of 26, the other oral drug that we know, SagiMed, but it has to start phase three, and the other drugs in development in phase three are injectables. And all the studies that we have done with payers, and especially prescribers, really put oral drugs as a preferred administration mode versus injectables.
None: Ah patients recruited officially enter the study and then have an additional 15% to 20% so it sounds like.
None: The conviction that the last patient first visit.
None: Will occur.
None: And by the end of the first half of this year or during the second quarter is extremely high.
None: Yeah.
None: Is there sort of a sooner rather than later aspect to that.
None:
Seamus Christopher Fernandez: I think we are very well positioned in this. Great And just as a follow-up question, as it relates to phase three, you commented that you've already kind of added in a further 5% of patients recruited officially into the study and then have an additional 15 to 20%. So it sounds like the conviction that the last patient's first visit will occur by the end of the first half of this year or during the second quarter is extremely high. You know, is there sort of a sooner rather than later aspect to that that you have higher conviction in?
None: That you have higher conviction in.
None: And then just secondarily, maybe you can update us on the.
None: Progress towards sort of the F. Four patients that I believe are more exploratory as part of the study.
So.
None: So we're starting to risk <unk>, we started with screening in the U S.
None: With the sites that are under central IRB.
None: And the opening of already the site is the following.
None: The plan.
None: There is one.
None: Principally.
None: As planned we are confident that there is.
Frederic Cren: And then just secondarily, maybe you can update us on the progress toward sort of the F4 patients that I believe are more exploratory as part of the study. So we are starting to re-screen, we started re-screening in the U.S., with the sites that are under central IRB, and the opening of all the sites is a following. The plan. There is one.
Yes.
One item we don't.
None: Control will be the screen failure rate following the introduction of the four two new antibodies that.
None: But we put in place following the recommendation of the data monitoring Committee.
None: We believe the impact will be limited but.
None: Only the future months, we will confirm that the screen failure or doesn't change significantly compared to the.
Frederic Cren: Thank you for joining us. One item we don't control will be the screen failure rate following the introduction of these autoimmune antibodies that we put in place following the recommendation of the data monitoring committee. We believe the impact will be limited, but only the future months will confirm that. But if the screen failure doesn't change significantly compared to what we have experienced in the past, we should be able to meet this end of recruitment as planned for the end of H1. We have had many webinar meetings called with all our sites, so they understand the situation.
None: What we have experienced in the past, we should be able to meet this.
None: End of recruitment.
None: Planned for the end of each one we have had.
None: Many webinar meetings called with all of our site.
None: They understand the situation.
None: They are not.
None: They are motivated to restart screening so really good positive feedback from how we handle this.
None: <unk>.
None: Then on the next two phase III, which is our phase III.
None: These are requested to secure full approval and that we plan to conduct in patients with compensated cirrhosis.
Frederic Cren: They are motivated to restart screening, so we really got positive feedback on how we handled this. Then on the next phase three, which is a phase three that is requested to secure full approval and that we plan to conduct in patients with compensated cirrhosis. We need to have this trial ongoing. When we fight for NDA, we are including patients with F4 Compensated Cirrhosis in the Exploratory Arm. We currently, out of those 200 patients, we will have approximately 30% with a four. We are not doing a second biopsy, but we have a very large set of non-invasive tests planned to be used in this patient that are stratified one-to-one-to-one in the exploratory core.
None: Need to have these trials are ongoing.
None: When we file for NDA.
None: We are.
None: Including patient with.
F. Four compensated cirrhosis is exploratory arm.
None: Currently out of those 200 patient we will have approximately 30%.
None: <unk>.
None: Sure.
None: We are not doing a second biopsy, but we have a very large set of noninvasive test.
None: Planned to be used in this patient that are stratified one to one to one.
None: It's Florida to record so that will give us valuable information.
None: On on our lovely.
None: Performance in these patient and will help us finalize the discussion.
None: With the FDA on the design of the.
Frederic Cren: So that will give us, I think, valuable information on how Lally performed in this patient and will help us finalize the discussion with the FDA on the design of this confirmatory trial. Great, thank you so much, and good luck with the continued progress and congratulations on the recent update. Thank you. We will now take the next question. From the line of Rami Katkhuda from Lifescyle Capital, please go ahead. Hey guys, thanks for taking my questions as well. Just a couple quick ones for me.
None: A confirmatory trial.
None: Great. Thank you so much.
None: Good luck with the.
None: Continued progress and congrats on.
None: The recent update thank.
None: Thank you.
None: Thank you.
We will now take the next question.
Speaker Change: From the line of Ron My gut Cuda from lifestyle capital. Please go ahead.
Speaker Change: Hey, guys. Thanks for taking my questions as well.
Speaker Change: Couple of quick ones for me first I guess when do you expect ex U S sites to begin enrolling patients again and then.
Rami Azeez Katkhuda: First, I guess, when do you expect FQS sites to begin enrolling patients again? And then, secondly, what milestones do you need to hit to draw additional tranches from the EIB loan? And could that occur before the third quarter?
Speaker Change: Secondly, what milestones you need to help drive additional tranches from the EIB loan and could that occur before the third quarter.
None: Okay. So.
None: The second question is easy we have met all the.
None: Requirement of the IV and that allowed us to draw the second tranche of $25 million.
None: And then if we want to.
Frederic Cren: Okay, so the second question is easy. We have met all the requirements of the IEB, and that allowed us to draw the second tranche of 25 million. And then, if we want to, we can borrow from the EIB. We need to, you know, discuss that with them. I think they're not close to it, but they are open to doing such a thing.
None: Put in place a new.
None: Loan with the IV will need to discuss that with them I think they're not close to it but they.
None: They are open to do such a thing, but we have not started discussing on that and then two when we plan to open the ex U S.
None: The size of Canada.
Frederic Cren: But we have not started discussing that yet. And then when we plan to open the ex-US sites in Canada, there are sites under central RERB. So those we plan to open those soon. And then the other countries, we start opening them starting from April.
None: Insight into central IRB. So those we plan to open those soon and then the other countries will start opening then starting from April with a focus for us.
None: On Europe.
None: And what I mentioned in my introductory that.
None: Most of our patients.
None: From.
None: The U S.
Rami Azeez Katkhuda: With a focus for us on Europe. What I mentioned in my introduction that, you know, most of our patients come from the US or North America, close to 70%, and an additional 21% come from the EU. So they're really a focus from our team to focus our effort in these two geographic areas. I know it's a bit early, but would you look to partner with Lanny in Europe as well?
None: In North America.
None: Close to 70% and an additional 21% coming from the EU.
None: There are really a focus from from our team to.
None: To focus our efforts in these two geographic areas.
Yes.
None: Got it.
None: I know, it's early but would you look to partner Lanny in Europe, as well and with that partnership come before or after the needed three readout.
None: Well.
None: Our strategy concerning Lanny is that we see that there are two strategic regionally.
Frederic Cren: And would that partnership come before or after the Native Cree readout? Well, our strategy concerning Lani is that we see that there are two strategic regions for Nash, that are Europe and the U.S. We want to keep them. Those write, I would say, bundled together as one.
None: For Nash.
None: Our Europe into the U S.
None: We want to keep those the right I would say bundled together.
None: One is so good.
None: More looking at the park.
None: Our theory.
None: Uh huh.
Rami Azeez Katkhuda: And so we would, we're more looking at partnering Europe and the U.S. together rather than splitting those. We think that an appropriate moment will be post-phase 3 because we are confident in the data we will generate both phase three and the ability to get approval based on the native 3D data. Got it. Thanks so much.
None: Europe, and the U S together rather than splitting votes.
None: We think that the appropriate moment will be both phase III, because we're confident in the.
None: The data, we will generate both phase III and the ability.
None: To get approval on based on the native three data.
None: Got it thanks, so much.
None: Thank you.
Rami Azeez Katkhuda: Thank you. We will now take the next question. On the line from Lucy Codrington from Jefferies, please go ahead.
None: We will now take the next question.
None: From the line of Lucy Codrington from Jefferies. Please go ahead.
Lucy Codrington: Hiya, thank you for taking my question. Sorry, I didn't quite catch it in a prepared remark. Could you just repeat the state of random, the kind of randomization post the Screening Resumption, and also just whether you had a set amount already in screening when the recruitment was halted, has that number changed within that screening pool given the kind of Safety Concerns is probably overstating it, but since that incident and then the required additional monitoring that the trial will entail, has that meant you've lost any patients within screening? And then just on the partnership, kind of commentary, I guess, I was going to ask if you're in any active discussions with potential partners and whether interest has increased since your recent data and the Res Meta and approval. I guess your comment just then suggesting you'd prefer to wait till after phase three might suggest that's not the case, but I guess, can you afford to wait till after phase three, given the cash constraints that you have? kind of routes in terms of a potential option agreement. Are these things being considered in order to get you to that data, which seems to be the most important thing? And then, I guess related to that, you mentioned potentially another EIB loan. How long do those loans take to negotiate?
Lucy Codrington: Hi, Thank you for taking my question.
Lucy Codrington: Sorry, I didn't quite catch in the prepared remarks can you just repeat.
Lucy Codrington: Stated random kind of randomization paces.
Lucy Codrington: Yeah.
Lucy Codrington: Screening machining and I'll say, just whether you had a set amount already in screening Wendy.
Lucy Codrington: And then Mcqueen them with halted has that number changed within that screening pool, given the kind of.
Safety concerns.
Lucy Codrington: Okay.
Lucy Codrington: And then the required.
Lucy Codrington: Additional monitoring the trial at Intel has that made it lost any patients with screening.
Lucy Codrington: And then just on the partnership.
Lucy Codrington: Kind of commentary I guess.
Lucy Codrington: I was going to ask if you are in any active discussions with potential partners on whether interest had increased.
Lucy Codrington: Recent data on the Master and appraisal I guess your comments, just then suggest need to wait till after phase three months suggest that no, but I guess can you afford to wait till after phase III given the cash.
Lucy Codrington: Strength that you have.
Lucy Codrington: Did you explore other.
Lucy Codrington: Kind of linked in terms of a potential option agreement that these type of things being considered.
Lucy Codrington: In order to get you to that data.
Lucy Codrington: Which seems to be the most important thing and then I guess related to that you mentioned about potentially another AIB line, how long do they take to negotiate.
Lucy Codrington: I'm just cognizant if any at all.
Lucy Codrington: And limited amount of time before.
Lucy Codrington: The cash runway expires. Thank you.
None: Yes, Okay. So I'll take the first two.
None: Question about <unk>.
None: The state to the trial and the partnering and I'll, let John answer.
John: The question about the European investment Bank, and how long that takes on screening what I've said is that we have more than 75%.
Frederic Cren: Just promise that we've only got, you know, a limited amount of The Cash Runway expires. Thank you. Yeah, okay.
John: Of the fish.
John: Needed in the for the main core that are randomized.
John: And that we have more than 300 basis 250 patient screening. So this the pool of patients in screening.
Frederic Cren: So I'll take the first two questions about, you know, the status of the trial and the partnering, and I'll let you answer. The question about the European Investment Bank and how long it takes for screening, what I said is that we have more than 75% of the fish needed for the main course randomized. And that we have more than 350 patients in screening. So this, the pool of patients in screening is diminishing, but it's not due to pushback or the change of attitude of the site toward Lanny Fibberner. To the contrary, as I said, we have had meetings, calls, webinars, a face-to-face meeting with the sites, and the excitement remains, especially after the legend data, patient screening is diminishing, it's just because of the sort of moment. There is a date of, let's call it a date of validity for the lab test and for the biopsy.
John: Diminishing, but it's not due to.
John: Push back or the change of attitude of the sites.
John: Towards.
John: Then if your burner to the contrary as I said, we have had there.
John: Meetings, KOL Webinars, a face to face meeting with the sites and they did.
Segment remains especially after the legend data the efficiencies screening are diminishing as just because there is a sort of moment.
John: There is a date of let's call it a data validity for the.
John: Yeah.
John: Test and for the biopsy and towards a certain moment.
John: We lose we lose those patients.
John: And then also mentioned.
John: Give some data about.
John: Alright, and what is important is that the countries, which we will reopen first is it really those countries that matter, which is North America.
John: In Europe.
John: When I say that matters is that they're providing.
John: The most.
John: The country, providing more efficiency in the trial.
Frederic Cren: And then also, I mentioned, you know, I gave some data about where the spares are, and what is important is that the countries which we will reopen first are really those countries that matter, which are North America and Europe. When I say that matters, it's that they are providing, and the most, countries are providing more patient in the Now concerning our cash runway.
John: Concerning our cash runway.
John: Yes, we have a comes for us a runway until early Q3.
John: Actually for US we are in.
John: We've seen a good moment with positive data in the Nash field.
John: To the magical approval, which has lifted.
John: A regulatory hurdle to me.
John: <unk>.
John: Patients do not need to go under biopsy.
John: Our.
John: We are in the.
John: Towards.
John: Okay.
All options are on the table.
John: Could be.
John: <unk>.
John: Working with a big pharma or it could be to go back to the capital market, we have a super.
Frederic Cren: Yes, we have a cash runway until early Q3. Luckily for us, we are in a good moment with positive data in the Nash field due to the Madrigal approval, which has lifted the regulatory hurdle, the need that patients do not need to go under biopsy, and Hauwaii. Thank you for listening. We are in the middle of a short break. We will be back in about 30 minutes.
John: Our strong shareholder base that has been supportive.
John: For the past 12 years.
John: So we think we are in the.
John: The positive the positive trend.
None: So maybe I'll, let <unk> answer.
None: Your question about the timing of the EIB sure we have continuous discussion with the EIB, but they are asked to come visit us on the site.
None: In a couple of weeks.
None: Two ways.
Frederic Cren: All options are on the table. It could be, as you mentioned, working with a big pharma, or it could be to go back to the capital market. We have, I think, a strong shareholder base that has been supportive for the past 12 years.
None: One way to shocked shocked.
None: The second would be below $10 million this could be managed within the existing loans.
None: Generally generally could be.
None: Within two or three months and the second option is a greater tranche.
Jean Volatier: So we think we are in a... in a positive, positive trend. So maybe I'll let Jean answer your question about the timing of the EIB. Sure, we have continued discussions with the EIB. By the way, they have asked to come visit us on the site in a couple of weeks. There are two ways. One way, the short circuit would be below 10 million. This could be managed within the existing loans, and generally, it could be within two or three months.
None: It would be managed to a new finance agreement.
None: They both would go with cash injections.
None: We're talking about potential capital increase so this could be managed together with this operation.
None: And for the second option I guess that with him within six months to one year. This could be possible to to discuss a set tranche, but again everything is depending on.
Jean Volatier: And the second option is a greater tranche, which would be managed through a new finance agreement. Obviously, both would go with cash injections. Frederic was talking about the potential capital increase, so this could be managed together with this operation. And for the second option, I guess that within six months to one year, this could be possible to discuss as a tranche. But again, everything is depending on, you know, future cash injections on which we are working actively. Thank you. Thank you. As a reminder, if you wish to ask a question, please press stars 1 and 1. We will now take the next question from the line of Jacob Mekhael from KVC Securities. Please go ahead.
None: Cash and cash future cash injection on which we are working actively.
None: Thank you.
None: Thank you as a reminder, if you wish to ask a question. Please press star one on one.
Speaker Change: We will now take the next question from the line of Jay Jacobs Mackay from KBC Securities. Please go ahead.
Speaker Change: Hi, there.
Speaker Change:
Speaker Change: Can you. Please provide some guidance on how we should look at R&D for 2024, and do you expect R&D to decrease once you have completed enrollment in the trial and just perhaps maybe to go back on the target of 950 patients.
Speaker Change: And do you think that targeted capable with U S sites or will you need the additional sites in order to reach that.
Speaker Change: And also perhaps a second question on that and do you need to meet certain threshold in terms of patient numbers from each region.
Jacob Mekhael: Hi there, and thank you for joining us. Can you please provide some guidance on how we should look at R&D for 2024, and do you expect R&D to decrease once you have completed enrollment in the trial? And just perhaps maybe to go back on the target of 950 patients, do you think that target is achievable only with US sites, or will you need additional sites in order to reach that? And also, perhaps a second question on that is, do you need to meet certain thresholds in terms of patient numbers from each region?
Speaker Change: So.
Speaker Change: In terms of R&D, let Joe give you the highlights for the coming years and with our hypothesis on.
Speaker Change: Our.
Speaker Change: Planning so when we say we.
Speaker Change: Plan to reach our enrollment.
Joe: And of which one does include.
Joe: The contribution.
Joe: Our outside.
Joe: North America.
Joe: Mostly from from Europe.
Joe: In terms of.
Joe: Minimal numbers to achieve.
Joe: I would say the only requirement.
Joe: If I'm wrong is.
Joe: Last year to intervene, but it came from the FDA.
Joe: At a certain percentage to come from from.
Joe: From the U S and we have largely achieved that target.
Frederic Cren: So, in terms of R&D, I'll let Jean give you the highlights for the coming years based on our hypothesis and our planning. So when we say we plan to reach enrollment at the end of each one, this includes [inaudible] North America, mostly from Europe, in terms of Minimum Numbers to Achieve, the only requirement. And if I'm wrong, I'll ask Pierre to intervene, but I think we came from the FDA wanted a certain percentage to come from the U.S., and we have largely achieved that target.
None: Okay. Thank you Scott maybe for your question about the trend of the R&D expense.
None: We should decrease slightly in 2024.
None:
None: Something around 10% plus 10%.
And then as you mentioned.
None: Yes, 25 should decrease.
None: Of course due to the the end of the recruitment in the end.
None: Investment to <unk>.
In Asia the recruitment.
None: Okay. Thank you very much very clear.
None: Thank you there are no further.
Jean Volatier: Okay, thank you. So maybe for your question about the trend of R&D expenses, we should increase slightly in 2024. You know, something around 10% plus 10%.
None: Okay.
None: Alright.
None: Okay.
None: I think we lost the operator, but so I'll just make the conclusion.
None: Just to mention that 23 was a busy year for our team.
None: And 'twenty 'twenty 'twenty four will be another mine.
Jean Volatier: But then, as you mentioned, the year after 25 should decrease, of course, due to the end of the recruitment and, you know, and the investment to finish up the recruitment. Okay, thank you very much. Very clear. Thank you. There are no further, I think we lost the operator, but I'll just make the conclusion, just to mention that 2023 was a busy year for our team at Inventiva, and 2024 will be another busy year with many milestones to achieve. What I think is really great for Inventiva is that we have an incredible asset; we have a neural compound with a very attractive and competitive profile. And clearly, the data we've generated makes Lani a compound that is very well placed to make it through the finish line in MASH-NASH, and we're convinced that Lani will play a key role in the treatment of patients with MASH.
None: Yeah.
None: This year with many milestones to achieve.
None: What the <unk> is really great for MLP rate that we have.
None: An incredible asset we have a lower compound.
None: With a very attractive and competitive profile.
None: Clearly the data we have generated mixed slightly compounded is where we will place to make it through the finish line and mashed Nash and we're convinced that <unk> will play a key role in the treatment of patients with Nash Nash.
None: So thank you very much for attending thank you for your support.
None: To continue the open dialogue throughout 2024, thank you very much.
None: This concludes today's conference call. Thank you for participating you may now disconnect.
Yeah.
None: [music].
None: Okay.
None: Okay.
None: [music].
Yeah.
None: [music].
Frederic Cren: So, thank you very much for attending, thank you for your support, and I look forward to continuing the open dialogue throughout 2017. Thank you very much. This concludes today's conference call. Thank you for participating. You may now disconnect. Thank you for watching!
None: Sure.
None: Yes.
None: [music].