Full Year 2024 Inventiva SA Earnings Call
Operator: Bye. Good day and thank you for standing by. Welcome to the Inventiva Full Year 2024 Financial Results webcast and 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. To ask a question during the session, you will need to press star 1 and 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 and 1 again.
Good day, and thank you for standing by and welcome to the Vantiv a full fledged full financial results webcast and conference call. At this time all participants are in a listen only mode. After the speaker's presentation that there'll be a question and answer session to ask a question. During the session you will need to press star one on your.
Speaker Change: Palisade you will then have an automated message advising your hand is raised to withdraw your question. Please press star. One again, please be advised that today's conference is being recorded I would now like turn the conference over to your first speaker today, Frederick Glenn C. O N K founder he's all hats off.
Operator: Please be advised that today's conference is being recorded.
Frederic Cren: I would now like to hand the conference over to your first speaker today, Frederic Cren, CEO and co-founder. Please go ahead, sir. Thank you, Operator. Good morning, good afternoon, everyone. Thank you for joining us to discuss our 2024 full-year financial results. We issued the full-year press release this morning, and the webcast will be available in the investor section of our website.
Frederick Glenn: Thank you operator, good morning, and good afternoon, everyone.
Frederick Glenn: Thank you for joining us to discuss our 2024 full year financial results.
Frederick Glenn: We issued a press release this morning.
Frederick Glenn: The webcast will be available in the investors section of our website.
Frederic Cren: I want to remind everyone that various statements that we may make today during this conference call and during the Q&A session will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1991. Joining me on this call is Jean Volatier, our Chief Financial Officer, and Pierre Broqua, CSO and co-founder. I will first cover some of the key highlights for 2024 and some recent updates of our activities. Before I leave the floor to Jean, we'll go over the full year financial results, and of course we'll have some time at the end of the call for a Q&A.
Speaker Change: I want to remind everyone that various statements that we may make today.
Speaker Change: This conference call and during the Q&A session will include forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995.
Speaker Change: Joining me on this call lithology, our chief financial Officer, and get walk up.
Speaker Change: So and co founder.
Speaker Change: I will first go over some of the key highlights for 2024 and the recent update of our activities before I leave the floor to show will go over the full year financial results and of course, we'll have some time at the end.
Speaker Change: The call for Q&A.
Frederic Cren: So on the highlight for 24. So 24 was ended on a very positive note and we started 2025 strong, ready and enthusiastic for what is ahead of us. In 2024, we have made significant strides in the clinical development of Lanyfibranor. And with the tremendous support and commitment of our clinical trial site, we have been able to close screening for our phase 3, native 3, early January 2021. We can therefore confirm that we target the completion of recruitment in H1 2025 as previously guided. This will start the countdown to our top-line result expected in the second half of 2026, making of lanifubranol the second oral drug that could be approved in the United States in March.
Speaker Change: So on the I like for 24. So 24 that was ended on a very positive note and we started to.
Speaker Change: 745 strong radio and enthusiastic for what is ahead of us.
Speaker Change: 24 with made significant strides in the clinical development of Glenn If you burner.
Speaker Change: The tremendous support and commitment of our clinical trial sites, we have been able to close screening for our phase III 83 early January 25.
Speaker Change: We can therefore confirm that with target completion of recruitment in each one to 725 as previously guided.
If we start to come down to our top line results expected in the second half of 2026.
Speaker Change: Glenn if you burn the second oral drug that could be approved in the United States in March.
Frederic Cren: In addition to be very close from reaching completion of enrollment in 2024 and in the first quarter of 2025, we had three data monitoring committee meetings with positive recommendation to continue NATIVE III without modification to protocol. The most recent one took place in February 2025, during which the safety data of more than 1,200 patients randomized in 83 were reviewed.
Speaker Change: In addition to be very close from reached completion of enrollment in 2024 and in the first quarter of 2025, we had the three data monitoring committee meetings with Covid positive recommendation to continue Nitty three without modification to the protocol.
Speaker Change: Most recent one took place in February 2025, during which the safety data of more than 1200 patient randomized in 83 were reviewed.
Frederic Cren: With this progress in our phase three, we're truly at an inflection point in our company's journey. And we have already begun strengthening our team to ensure we're fully prepared for successful regulatory submissions and the commercialization of Lanifex.
Speaker Change: With this progress in our phase III, we're truly at an inflection point in our company's journey.
Speaker Change: And we have already begun strengthening our team to ensure we're fully prepare for a successful regulatory submissions and the commercialization of Lendingtree brand.
Frederic Cren: In 2024, we also reinforced our clinical data set for Lannisiburnor with the publication of the positive results of LEGEND, our combination proof-of-concept trial with Lannisiburnor and impact-based flows in inpatient with MASH and type 2 diabetes. The primary endpoint was met with a statistically significant reduction in HbA1c with Lannis-Ribbentrop alone and in combination. Insulin sensitivity was improved, consistent with other studies, and additional improvement was observed in combination with MPAG-E5. markers of liver injury were significantly improved and this improvement was solely driven by Lannister. The second goal of this trial was to look at the potential mitigation of the weight gain when adding an FGLT2 inhibitor to LaniFibranor.
Speaker Change: In 2024, we also reinforced our clinical data set for legacy burner with the publication of the positive results of legend or combination proof of concept trial with lending she burner and impact of flooding in patients with Nash and type two diabetes.
Speaker Change: The primary endpoint was met with a statistically significant reduction HBA, one feet with luxury burner alone and in combination.
Speaker Change: Infill in sensitivity with improved confidence consistent with other studies and additional improvement was observed in combination with impacted flows.
Speaker Change: Markers of liver injury were significantly improved and this improvement was fully driven by line of Hubert.
Speaker Change: The second goal of this trial was to look at the potential mitigation of the weight gain without being a net <unk> two <unk> two inhibitor to Lendingtree burner, we were very pleased to show that the combination of lanni with NPD flowed them completely mitigate the weight gain.
Frederic Cren: We were very pleased to show that the combination of Lani with Empagliflozin completely mitigates the weight gain. Furthermore, LaniFibranor alone, and in combination, leads to a shift towards metabolically healthy adipose tissue. Finally, meta-analysis data suggest that GLP-1 has a similar effect when combined with PPAR. This study is particularly significant given the high prevalence of type 2 diabetes among patients affected by MAP. We are convinced that the profile of LANIN is ideal to treat patients with advanced fibrosis and diabetes, with patient populations which is hard to treat and high risk to progress to cirrhosis.
Speaker Change: More than a few brenner alone and in combination leads to a shift towards metabolically LCR deposit tissue.
Speaker Change: Finally meta analysis data suggest the GSD one of a similar effect, where it can be when combined with PPR.
Speaker Change: This study is particularly significant given the high prevalence of type two diabetes among patients affected by much.
Speaker Change: We're convinced that the profile of planning is ideal to treat patients with advanced fibrosis and diabetes.
Speaker Change: The patient population, which are to treat an iris to progress to cirrhosis.
Frederic Cren: We're looking forward to... to look more in-depth at our learning effect when combined to other drugs, particularly GLP-1. And we have randomized approximately 15% of patients on GLP-1 in the phase three. This year, we also announced that our partner, EPALYS, has launched the clinical development of lanifibranol in Japan with the initiation of a phase one study. We believe that with the licensing agreement that we have in place in Japan, South Korea with EPALYS, and in China with CTTQ, lanifibranol will be ideally positioned to potentially become the leading oral drug in MASH in these two important geographic areas.
Speaker Change: We're looking forward.
Speaker Change: Looking more in depth at our learning effect will combine two other drugs, particularly <unk> had we have randomized approximately 15% of patient.
Speaker Change: <unk>.
Speaker Change: In the phase III study.
Speaker Change: This year, we also know that our partner <unk> Palace has launched the clinical development of <unk> in Japan with the initiation of a phase one study.
Speaker Change: We believe that with the licensing agreement that we have in place in Japan, South Korea, with our pilots and in China with Citi TQ 90, Hubert nor will be ideally positioned to potentially become the leading oral drug in March it has two important geographic areas.
Frederic Cren: looking now at the organization and at the governance. We're committed to make planning a success story for patients. And this is definitely a priority for Inventiva. We're focusing on changing and challenging all our resources and efforts into achieving this. As part of this process, we are reinforcing our development team to ensure that we're fully prepared for regulatory filing and the potential commercial loan.
Speaker Change: Looking now at the organization and at the governance.
Speaker Change: We're committed to make plenty of success story for patient.
Speaker Change: And this is definitely to your priority for England keep up we're focusing on change and challenging all our resources and efforts into achieving this goal.
Speaker Change: Part of this process, we are reinforcing our development team to ensure that we're fully prepare for regulatory filing and the potential commercial launch.
Frederic Cren: In February, following a strategic review, we announced the decision to focus all of our resources to the development of life. Unfortunately, this decision comes with a stop of all preclinical activities not related to learning and would lead to a reduction of approximately 50% of our work. I want to emphasize that this was not an easy decision, our research team has been core to Inventiva for the past 12 years, and has been instrumental in the development of LIFE. We are currently in negotiation with the Worker's Council and while I am unable to comment further at this stage, we are committed to working together through this transition.
Speaker Change: In February following a strategic review, we announced the decision to focus all of our resources to the development of <unk>.
Speaker Change: Unfortunately these two.
Speaker Change: Given current with the stop of all preclinical activities not related to learning.
Speaker Change: And it would lead to a reduction of approximately 50% of our workforce.
Speaker Change: I want to emphasize that is what is not an easy decision and what are our research team has been core to Indian teed up for the past 12 years and has been instrumental in the development of land.
Speaker Change: We are currently in negotiation with a worker counsel and while I'm unable to comment further at this stage, we're committed to working together through this transition.
Frederic Cren: Regarding the governance of Inventiva, we also reinforced it and we reinforced our board of directors with the appointment of three new board members. The first one is André Turenne, the President and CEO of the Boston-based Biotech Matchpoint Therapeutics and former Global Head of Business Development at San Jose. In December, Srini, the founder and partner of Samsara Capital, joined us.
Speaker Change: Regarding the governance of immune Tivo, we also reinforced it and were enforced our board of directors with the appointment of three new <unk> New Board members.
Speaker Change: The first one is on Japan, the president and CEO of the Boston based biotech match point therapeutics and for more global head of business development at Sanofi.
Speaker Change: In December we need a founder partner of Sunpower capital joined Us.
Frederic Cren: and we also nominated Mark Pruzanski as chairman of the board. You all know, you all are familiar with Mark. He's been the CEO and founder of Intercept and has shaped the mash market over the last Mark brings us, of course, a wealth of experience in both Smashfield and the U.S. along with deep expertise in financial strategy. We're excited to have him on board as we work together to achieve our mission of bringing learning to patients and driving meaningful progress in the treatment.
Speaker Change: We also nominated Mark presents key as chairman of the Board you. All know you all are familiar with Mark is being the CEO and founder of <unk> and that's it.
Speaker Change: Shaped the mass market over the last years.
Speaker Change: Mark brings of course, a wealth of experience in both smashed field in the U S.
Speaker Change: Along with deep expertise in financial strategy. We're excited to have him on board as we work together to achieve our mission of bringing land to patient and driving meaningful progress in the treatment of March.
Frederic Cren: Now finally before I hand over to Jean, the financial situation in 2024 we successfully closed on several dilutive and non-dilutive financing operations, raising approximately a total of 184 million dollars in gross proceeds. Most of these amounts come from our three trans-financing of $125 million each. This financing came from existing and trusting investors, and especially new investors. We received the first tranche in 2024 and will be eligible to receive the second tranche following the announcement of end of randomization and we should have then met all operational condition precedents necessary for this second tranche.
Speaker Change: Now finally before I hand over to show the financial situation in 2024, we successfully closed on.
Speaker Change: On February <unk>, dilutive and non dilutive financing operation raising approximately a total of $184 million in gross proceeds.
Speaker Change: Most of these amount come from our three tranche financing of $125 million each.
Speaker Change: The financing came from existing and crusty, investor and especially new investor.
Speaker Change: We received the first tranche in 2024 and will be eligible to receive the second tranche following the announcement of Wendover under musician.
Speaker Change: We should have been met all operational condition precedent necessary for the second tranche.
Jean Volatier: Let me now turn over to Jean, who will provide you with more details on our 2024 financial report. Thank you Frederic, good morning, good afternoon everyone and thank you for joining us on this call. So yesterday I said we have issued our press release covering the full financial results for the fiscal year 24 and of course I will provide you with key highlights. Happy to answer more detailed questions during the Q&A time.
Speaker Change: Now turn to over to Joel who will provide you with more details on our 2024 financial report.
Joel: Thank you for Derek Good morning, Good afternoon, everyone and thank you for joining us on this call. So yesterday I said, we have issued our press release.
Speaker Change: Covering the full financial results for the fiscal year 'twenty four and of course that would provide you with key highlights Pete to answer.
Joel: More detailed question during the Q&A time.
Jean Volatier: So I start with the cash position and cash flows. So we have reached at the end of 24 96.6 million of cash position versus 36 million at the end of December 23. Therefore, a net positive variance of close to 61 million euro. As a matter of fact, this represents half a year, roughly, of annual OPEC. A key fact, as said by Frederic, is of course the 184 million US dollars, 170 million euro of raising under different operations, dilutive and non-dilutive. The fourth principle are, of course, the raising of the second tranche of 25 million drawn in January 24 from the European Investment Bank.
Joel: So I start with the cash our cash position and cash flows. So we have reached at the end of 'twenty four.
Joel: $96 6 million of cash position versus a $36 million at the end of December 'twenty three.
Joel: Therefore, our net positive variance of close to 61 million Euro as a matter of fact district business after a year roughly.
Joel: <unk> of our annual Opex.
Joel: A key factor as I said by Fidelity keys of Costa.
Joel: $184 million 170 million Euro Oh, raising under a.
Joel: Different operation did you even non dilutive.
Joel: The fourth principle are of course, the raising of the second tranche of 25 million drawn in January 24 from the European investment Bank to second in July 24.
Jean Volatier: The second in July 24 was the raising of 20.1 million with the issuance of YLT deals. The biggest one, of course, related to the up to 348 million finance structure transaction announced in October 14, 24, represent 116, 116 million euro net proceeds received during the fourth quarter. And eventually we received also the milestone, the first milestone of CTTQ, our Sinobio farm, our Chinese partner, as part of the financing in October. And you remember that there are three tranches, three milestones related to this transaction. Also, we can come back on that. So therefore, we have we have confirmed we do confirm the cash runway guidance.
Joel: The raising of $20 1 million.
Joel: Issuance of why Ltd's.
Joel: The biggest one of course related to the up to $348 million.
Joel: Finance structured transaction announced in October 14th 24 represents 116, one 6 million Euro net proceed.
Joel: Received during the fourth quarter and eventually we received also the milestone the first milestone of GTT to our <unk>, our Chinese partner <unk>.
Joel: Yeah.
Joel: Part of the financing in October and you remember that there are three tranches.
Joel: Three milestones related to this transaction also we can come back on that so therefore, we have a we have confirmed we do confirm the cash are underway.
Jean Volatier: Disclosed previously, meaning we can we can operate until September 25 without the contemplated second tranche of the financing. And after the contemplated second tranche of the financing, we would we should reach September 26.
Joel: Guidance.
Joel: Clothes that previously meaning.
Joel: We can we can operate until September 25.
Joel: Without the contemplated the second tranche of the financing and after the contemplated second tranche of the financing we would we should reach a September 26.
Jean Volatier: Let's talk now about the key figures of the Profit and Loss account. We have recorded revenues in 2024 of $9.2 million, and it refers to the milestones I talked about earlier with CTTQ Sinopio Farm, compared to $17.5 million on the same period in 2023. The other income line is stable at $5.5 million, compared to $5.7 million. It represents, as usual, essentially the R&D French tax credit. Of course, the most important line is the R&D expenses, which still represent more than 80% of our global operation expense, amounting to $19.9 million in 2024, compared to $110 million in 2023, showing a decrease of 17%, which was due to the delays we have to face in 2024.
Joel: Let's talk now about the key figures of the profit and loss account. So web recorded revenues in 'twenty for us.
Joel: $9 2 million and it refers.
Joel: With to the milestone that I talked about earlier with <unk>.
Joel: Johan.
Joel: Compared to $17 5 million on the same period in 2003. The other income line is stable at five 5 million.
Joel: Five compared to $5 seven each represent as usual essentially the R&D French tax credits.
Joel: Of course, the most important line is the R&D expenses, we still represent more than 80% of our.
Joel: Oprah Global operation expense, so amounting to $19 9 million in 24 compared to $110 million in 'twenty, three showing a decrease of 17% which was due to the delays we have to face in 'twenty four.
Jean Volatier: To be noted, as announced during the second half of 2024, these R&D expenses have started to increase again, following the restart of the patient recruitment in that period. The marketing and business development line is still not significant at 2 million, stable compared to 23, but with the approaching of the end of the phase 3, expected to increase in the near future because we are start preparing the NDA filing and the commercialization capability. In terms of GNAs, reaching 15.8 million for 2024 compared to 13.8 in 2023, so a slight increase of 14%. We have had a complex year in terms of transactions, but also we have reinforced our IP position and therefore we have a slight increase in particular in other legal and compliance.
Joel: To be noted that.
Joel: <unk> announced that during the second half of 'twenty for this R&D expense. It has started to increase again for in the restart of the patient recruitment in that difference.
Joel: Marketing and business development line is still not significant at 2 million stable compared to 23, but with the approaching of the end of the phase III.
Joel: <unk> two <unk> to increase in the near future because we will start preparing the NDA filing and commercialization capabilities.
Joel: In terms of G&A.
Joel: Reaching $15 8 million for 24% compared to $13 eight in 'twenty three so a slight increase of 14%.
Joel: We haven't had a complex here in terms of transactions, but also we have reinforced our IP position and therefore.
Joel: We have a slight increase in particular in the other legal and compliance fees.
Jean Volatier: There is a rather unusual amount, you can note it in the net financial loss, 86 million compared to 5 million in 2023, two items, one of items of 33 million point four, which is related to a specific IFRS retreatment, non-cash, related to the fair value of the second tranche to be realized very soon and has to be treated as a derivative instrument since considered as a call option instrument. And we have also this year 12.2 million of non-cash interest and related to the loans and related to the royalty certificates amortization.
Joel: There is a rather unique unusual amount you can noted in the net financial loss.
Joel: <unk> 6 million compared to $5 million and 23, two items are one off items of $33 million four which is related to a specific job iff's with treatment noncash related to the fair value of the second tranche to be to be a real.
Joel: We expect very soon and has to be treated as a derivative instruments since considers as a call option instruments.
Joel: And we have a sweat we have also received $12 2 million of cash.
Joel: Cash offer noncash interest and related to the to the loans and related to the relative royalty certificates amortization.
Jean Volatier: Bottom line, the company's net loss for the full year established at $184.2 compared to $110,000,000.4 in 2023.
Joel: Bottom line the company's net loss for the full year established at 184 to.
Joel: $184, two compared to a $110 million for in 'twenty three.
Frederic Cren: I will now turn it over to Frederic for the conclusion and Q&A. Thank you for your attention. Merci Jean. So we've made important improvements, significant strides, and I'm confident that we have a tremendous opportunity ahead of us with Lannifield Renoir. If you look at 2025, we anticipate announcing the completion of randomization and the release of the second tranche of $127 million from our Structural Finance Fund. Today, we are the only phase 3 that is recruiting currently and evaluating a neural liver-targeted drug candidate. We have a robust data set, including our phase 2, in which we observe an improvement of one-stage fibrosis in just six months of treatment.
Joel: I will now turn it over to Fredrik for the conclusion and Q&A. Thank you for your attention.
Joel: <unk> also we've made important improvements significant strides and I'm confident that we have a tremendous opportunity ahead of us with <unk>, if you'd run or if you look at 2025, we anticipate announcing the completion of randomization in the release of the second tranche of $127 million from a structured financing.
Joel: Today today, we are the only phase III.
Joel: That is recruiting year.
Joel: Currently and evaluating in a normal liver targeted drug candidates, we have a robust data set including our phase II in which we observed an improvement of one stage fibrosis in just six months of treatment.
Frederic Cren: The demand for mass treatment is clear and the available treatment options are still limited today to a single mecaninol vaccine. We believe that given the heterogeneity of the patient population and the broad prevalence of MASH, having multiple oral treatment options would be a game-changer for patients.
Joel: The demand for mass treatment is clear.
Joel: The available treatment options are still limited today to a single mechanism of action.
Joel: We believe that given the Altair regenerative the patient population in the broad prevalence of mash, having multiple oral treatment option would be a game changer for patients.
Frederic Cren: Thank you and we are now open.
Joel: Thank you and we are now open we now open the floor for questions.
Operator: We now open the floor for questions. Thank you. To ask a question, you will need to press star 1 and 1 on your telephone and wait for your name to be announced.
Speaker Change: Thank you to ask a question press star one on one on your telephone and wait field names, we announce to withdraw your question. Please press star one on one.
Operator: To withdraw your question, please press star 1 and 1 again.
Operator: We will now go to our first question. One moment, please.
Joel: We will now go to our first question.
Joel: One moment please.
Nicole: And your first question comes from the line of Ritu Bharel from TD Cowan, please go ahead. Hi, everyone. This is Nicole online for Re2. Just a quick question. Are the background doses for the patients on background doses of GLP-1, are they low-dose diabetic doses or are they also composed of high-dose for weight loss? And just a quick follow-up, how many patients do you guys estimate that you have enrolled that are on background SGLT2 inhibitors? Thank you. So on the first one, I'll answer and then I'll let Pierre on the LGLT2, if you like. Oh, go ahead.
Speaker Change: And your first question comes from the line of Ritu <unk> from TD Cowen. Please go ahead.
Speaker Change: Hi, everyone. This is Nicole on line for retail just a quick question are the background doses.
Speaker Change: Patients on background. This isn't guilty wines are they low dose diabetic doses or are they also competitive fight us for weight loss and just a quick follow up how many patients do you guys estimate that you have enrolled that are on background <unk> LTE tenants have areas. Thank you.
Speaker Change: On the first one I'll answer and then I'll, let Pierre the agility to generic Oh go ahead.
Frederic Cren: You know both. Oh, go ahead. No, no. GLP1 is mostly anti-diabetic dosing. It's not only semaglutide. It's other, well, cement muti is included, but you have also other cases, other GFPs. and by the top of my head you had between six to eight percent of patients on FGT2 inhibitor baseline. Great, thank you. Thank you.
Speaker Change: Sorry go ahead.
Speaker Change: <unk> is mostly.
Speaker Change: TWC dosing, it's not only <unk>.
Speaker Change: It's other well magnetite is included but you have also other case.
Speaker Change: Other <unk> agonists.
Speaker Change: And.
Speaker Change: By the top of my head yet between 6% to 8% of patients on <unk> two inhibitor base.
Speaker Change: Baseline.
Speaker Change: Great. Thank you.
Operator: We will now go to the next question.
Speaker Change: Thank you.
Speaker Change: I will now go to the next question.
Shan Harmer: And your next question comes from the line of Shan Harmer from Jeffreys, please go ahead. Hi, thank you for taking my questions. So I know you expect to complete enrolment within the first half of this year, but what's your level of confidence in randomising that last patient and main cohort by 30th April to secure that €116 million capital increase? And then secondly, given it's likely you have cash, including this second tranche, just to the readout in 2H26, what are the plans for any additional financing? And I know you previously communicated that it would make sense post the data to have a partner.
Speaker Change: And your next question comes from the line of some hammer from Jefferies. Please go ahead.
Some Hammer: Alright. Thank you for taking my questions. So I know you expect to complete enrollment within the first half of this year.
Some Hammer: But what's your level of confidence in brand marketing that last patient cohort by that April to secure that 116 million Euro capital increase.
Some Hammer: And then secondly, and given it's likely you have cash including this.
Some Hammer: Second tranche to just the readout and curates 26, what are the plans for any additional financing and I know you previously communicated that it would make sense post the data for it to have a partner.
Shan Harmer: What's the level of interest here from pharma to be able to close a deal as quickly as possible? Thank you.
Some Hammer: A level of interest from pharma to be able to close the deal as quickly as possible. Thank you.
Frederic Cren: So many questions. So the first one on the confidence of recruiting before the end of April, I would say it's high confidence given we have communicated to all sites to stop screening at the beginning of the month of January. And we took that decision because we had sufficient patients already randomized and sufficient patients. in screening to reach the target of 969 patients, which are the patients that we need to enroll in the main cohort to achieve 90% of firing with the assumption of the SAP. The average screening period is between 10 to 12 weeks. So we feel, you know, very.
Speaker Change: So many questions. So the first one on the on the confidence of recruiting before the end of April which reach high confidence given we.
Some Hammer:
Some Hammer: Communicated to all side to stop screening at the beginning of the month of January.
Some Hammer: And we took that decision because we had sufficient patient already randomized and sufficient patient.
In screening to reach the target of 969 patient we charge the patient that we need to enroll in the main cohort to achieve 90% of bio readiness.
Assumption of the.
Some Hammer: The average screening period is between.
Some Hammer: 12 to 12 10 to 12 weeks.
Some Hammer: And so we feel.
Some Hammer: Very.
Frederic Cren: optimistic that we will meet that end of April object. On your question about partnering, there is a lot of interest in the mass market. I would say finally, given that we've been going through a series of failures in the field. Luckily, some companies have reported positive data. And more importantly, Madrigal resmetiron drug has been approved. There is no need of biopsy to prescribe it. And the commercial launch has been very solid. And they're definitely in the direction of the blood buster potential. So, of course, that drives a lot of interest. We believe we have a very strong package.
Some Hammer: Optimistic that we'll meet that end of April.
Some Hammer: <unk>.
Some Hammer: On your question about.
Some Hammer: Partnering.
Some Hammer: There is a.
Some Hammer: A lot of interest in the mass market.
Some Hammer: I would say finally.
Some Hammer: He then.
Some Hammer: We've been going through.
Some Hammer: A series of failures.
Some Hammer: Field and Luckily.
Some Hammer: Some companies have reported.
Some Hammer: We reported positive data.
Some Hammer: And more importantly, magical risk Metro and drug has been approved there is no need of biopsy to prescribe it and the commercial launch has been very solid and there definitely is.
Some Hammer: The direction of.
Some Hammer: A blockbuster potential total for that.
Some Hammer: Drives a lot of interest we believe we have a very strong package. We are the only oral drug currently in phase III development.
Frederic Cren: We are the only oral drug currently in phase three development. Most likely, once we announce the end of enrollment, we can reassert that it will be the next oral drug to be potentially approved. And given the results we have had in the 5th to B, we feel it's really strong on the and you know, the commercial success of Nanny Fibonacci. on how we manage our resources. Of course, we're actively managing our financial resources and we're confident that the step we're taking will allow us to execute on the clinical trial. We work and we're committed to advance the clinical program and ensure the long-term value of learning.
Some Hammer: Most likely once we will announce the complete end of enrollment.
Some Hammer: We assert that will be the next oral drug to be potentially approved.
Some Hammer: And given the results we've had in the fifth to be we've seen extremely strong on the.
Some Hammer: Okay.
Some Hammer: <unk> successful offline if you Bernard.
Some Hammer: On the AR, we manager our resources of course, we're proactively managing our financial resources and we're confident that the steps, we're taking will allow us to execute on the clinical trial.
Some Hammer: We work and we're committed to advance the clinical program and ensure the long term value of learning and of course, while we do that we continue evaluating all options to secure the funding needed to.
Frederic Cren: And of course, while we do that, we continue evaluating all options to secure the funding needed to achieve our objective, which is to execute the clinical trial, file for NDA, and commercialize them. commercialized land first in the U.S. and then in the European community.
Some Hammer: To keep it to achieve our objective which is to <unk>.
Some Hammer: Acute clinical trial filed for NDA and commercial either.
Some Hammer: Commercialized Lanny first in the U S and then.
Some Hammer: And the European community.
Some Hammer: Thank you.
Operator: Thank you.
Some Hammer: Thank you.
Annabel Samimi: Your next question comes from the line of Annabel Samimi from Seaful. Please go ahead. Hi, thank you for taking my question. So, on the screening, again, is there any specific rate-limiting step on that screening that could derail that last person who is enrolled into becoming an actual randomized patient in the primary arm? And then, secondly, I guess now that the – as you've alluded to, that the match market appears to be forming with the first approved treatment, the profile of FGF21s are emerging, and there's additional data emerging on incretins being able to drive match resolution.
Speaker Change: Your next question comes from the line of about some Muni from Stifel. Please go ahead.
Speaker Change: Hi, Thank you for taking my question.
Speaker Change: On the screening again is there any specific rate limiting step on that screening that could derail that last person who is enrolled into becoming.
Speaker Change: And actual randomized patient.
Speaker Change: And the primary arm.
Speaker Change: And then secondly.
Speaker Change: I guess now that the.
Speaker Change: You've alluded to that the Nash market appears to be for me the first approved treatment.
Speaker Change: The profile of FGF clean ones are emerging and there's additional data emerging on encryption is being able to drive Nash resolution.
Frederic Cren: Has the way you thought – you think about the market and the population that LANi would be most appropriate for changed at all, and how do you see this market fragmenting with the potential introduction of LANi? So thank you, Annabel, for this question. So it's very interesting. So to your first question, what can derail the randomization of the last patient? Once the patient is in the screening pool, we have a certain amount of period of time to complete all the examinations that are on the protocol. So during that period, we need to do all the lab tests.
Speaker Change: Has the way you thought.
Speaker Change: Think about the market and the population Atlanta be glad it would be most appropriate for changed at all and how do you see this market fragmenting.
Speaker Change: With the potential introduction of <unk>.
Speaker Change: So do you think that had been for this question.
Speaker Change: Very interesting to.
Speaker Change: So your first question, Ken what can derail the randomization of the last patient.
Speaker Change: Once sufficient isn't just screening pool, we have a certain amount of period of time to complete all the examination that are under protocol. So during that period, we need to do all the lab test we need to do the biopsy the biopsy part Digitalized and there they are rich centrally and its all that profit that takes.
Frederic Cren: We need to do the biopsy. The biopsy are digitalized and they are read centrally. And it's all that process that takes between eight to 12 months, 12 months, weeks. And then Once a patient is randomized, there is an appointment in each to show at the hospital, and then he's randomized in the study. So that's why this period takes a certain period of time. There is a total amount of time for that period. So at a certain moment, if we see that, you know, the patient doesn't present himself to a... to an appointment, or the site is not reactive enough, and so this period of time to screen and randomize a patient is overdue.
Speaker Change: Between eight to 12 months 12 months weeks.
And then.
Speaker Change: Once a patient is randomized.
Speaker Change: There is an appointment in each to assure the hospital.
Speaker Change: And then.
Speaker Change: He's randomize the ore.
Speaker Change: Our study.
Speaker Change: That's why this period takes a certain period of time there is a.
Speaker Change: Total amount of time.
Speaker Change: For that.
Speaker Change: That period so.
Speaker Change: At a certain moment, if we see that the patient doesn't.
Speaker Change: Resent himself to.
Speaker Change: To an appointment.
Speaker Change: Or the site is not reactive enough control.
Speaker Change: This period of time to screen and randomize the patient is overdue.
Frederic Cren: We can screen fail the patient automatically. So that's why he's confident that. We will... and Randall May, the last patient. as guided before. The end, the first half of. H1-25.
Speaker Change: Can screen failure patient automatically so that's why you get confident that.
Speaker Change: We will.
Speaker Change: Randomize the last patient.
Speaker Change: As guided before.
Speaker Change: The first half of.
Speaker Change: H 125.
Frederic Cren: On your second question on where we see Lany play a role in the market shape, as I said before, Madrigal's launch really showed that there is a huge market. even more so because we believe Magigold is not a tremendously efficacious drug, so we believe the market will further develop when we will arrive with a more efficacious drug. And also semaglutide with the commercial marketing of Novo will help enlarge. the market. Where we see Lany work clearly, this is something we get extremely positive feedback, is we have a drug that is really ideal for patients that have advanced fibrosis, F2F3, and on top F type 2 diabetes.
Speaker Change: On your second question on the <unk>.
Speaker Change: Where we see <unk> play a role in the market shape.
Speaker Change: Before Matt.
Speaker Change: Madrigal launch really show that there is a huge market.
Speaker Change: And even.
Speaker Change: Even more so because we believe margin goal.
Speaker Change: It's not a tremendously efficacious drug so we believe the markets will further develop win when we will arrive with a more efficacious drug and also <unk> tied with a power commercial marketing of of Novo will.
Speaker Change: And large.
Speaker Change: The market, where we see Lenny works clearly and this is something we get to truly positive feedback is we have a drug that is really ideal for patients with advanced fibrosis, if two or three and on top of type two diabetes.
Frederic Cren: This is a large population. We estimate that more than 50% of patients with MASH F type 2 diabetes, especially in the F2F3 population. This is a fibrosis progression that is faster than the overall population. They are more difficult to treat in the profile of Lany where we can see fibrosis reduction in six months. We can see a resolution of NASH, and especially a strong insulin sensitivity activity with a drug that helps you control your diabetes is a profile that resonates very well. And then lastly, and that's something Really important to highlight is that MP-PAR is a well-known mechanism with endocrinologists and diabetologists.
Speaker Change: With large population, we estimate that more than 50% of patients with Nash of type two diabetes, especially in two.
Speaker Change: Two or three population. This is a population which has a.
Speaker Change: Fibrosis progression that is faster than the overall.
Speaker Change: Relation they are more difficult to treat and the profile of learning, where we can see fibrosis reduction in six months, we can see a resolution of Nash and especially a strong insulin sensitivity activity.
Speaker Change: <unk>.
Speaker Change: A drug that helps you control your diabetes is a profile that resonates very well and then lastly in.
Speaker Change: And Thats something.
Speaker Change: Really important too Twilight.
Speaker Change: Keep ours as well.
Speaker Change: Well known mechanism with endocrinologists and diabetic allergies in the U S alone you have close to 6 million prescription of Bayou.
Frederic Cren: In the U.S. alone, you have close to 6 million prescriptions of PIO. Paglio is a, as you know, old P-PAR-Gamma. It's called it a first generation P-PAR-Gamma with a profile that is really less attractive than ours but still, even if generic, even if it's not promoted, you have 6 million scripts. every year written in the U.S. which really demonstrates that these diabetologists and endocrinologists are very familiar, very used to prescribe PPAR's mechanism and so they will be we think attracted by the profile of Lannister.
Speaker Change: <unk> is a as you know.
Speaker Change: All the people our gamma let's call it a first generation <unk> gamma.
Speaker Change: With a profile that is really.
Speaker Change: Less attractive than ours, but still even if generic even if it's not prescribed promoted Jeff 6 million scripts.
Speaker Change: Every year written in the U S, which really demonstrates that.
Speaker Change: Diabetes <unk> endocrinologists are very familiar very used to prescribe.
Speaker Change: Tariff mechanism until they will be.
Speaker Change: As we think attracted by the profile of lunch.
Frederic Cren: Fantastic, thank you very much.
Speaker Change: Fantastic. Thank you very much.
Frederic Cren: Thank you.
Speaker Change: Thank you.
Ed Arks: Your next question comes from the line of Ed Arks from HC Wainwright and Company, please go ahead. Hi, good morning, everyone. Thanks for taking my questions. Just a couple for me.
Speaker Change: Your next question comes from the line of at all from H C. Wainwright and company. Please go ahead.
Speaker Change: Hi, Good morning, everyone. Thanks for taking my questions just a couple from me.
Speaker Change:
Speaker Change: So I'm just.
Jean Volatier: I wanted to get your thoughts on R&D expenses throughout the year, considering both the impact of the recent reduction in the workforce and the Elimination of the Early Programs, but also as well the full enrollment of Native 3 in a few months and the carrying expenses of that. And then also... Relatedly, just wondering if you could... help us understand any potential milestone payment receipts. for this year that you would expect. Thanks so much.
Speaker Change: Wanted to get your thoughts.
Speaker Change: On R&D expenses throughout the year, considering both the impact of the recent reduction in workforce.
Speaker Change: The elimination of the early programs.
Speaker Change: But also as well the full enrollment of neither three.
Speaker Change: In a few months.
Speaker Change: The carrying expenses of that and then.
Speaker Change: So relatedly just wondering if you could.
Speaker Change:
Speaker Change: Help us understand any potential milestone payment receipts.
Speaker Change: For this year that you would expect thanks so much.
Jean Volatier: Jean, do you want to take these questions? Sure. So, for the profile, let me say, of the R&D expenses this year, as I said, decreased by 17% because we know we have to face some operational problems, but we have restarted the recruitment in Q2. So, the decrease versus last year and versus budget also, which represents basically something like 20 million, represents this momentum for 2024. If we talk about 2025, we come back, I would say, we come back to the normal way. We expect, compared to this year, a slight increase in the expenses, as I mentioned, because we will start, and Frederic said also, we start to prepare the commercial capabilities.
John: John do you want to take these questions sure.
John: So for the profile of me say of the R&D expenses. This year as I said decreased by 17% because we know we have to face some.
John: Some operational problems.
John: But we have we stopped the recruitment.
John: In Q2, so the decrease versus.
John: Last year and versus budget, or so which is basically.
John: I think that 20 million representatives.
John: The momentum for 2004.
John: We took about 195.
John: We come back I would say, we'll come back to the normal way.
John: We expect compared to this year, a slight increase in the expenses as I mentioned, because we will start <unk> et cetera. So we start to prepare the commercial capabilities, we will focus on the.
Jean Volatier: We will focus on the NDA filing also, so it should increase, let's say, by 10 to 20% compared to this year. And with regards to the expected milestones, as of today, what we know about are the milestones related and connection with the transaction, as you know, because there are three milestones expected from our Chinese partner, CTTQ, one have been raised, have been collected in 24, and there is one milestone per tranche. So, we are contemplating the second tranche of the financing in 25. So, together with the second tranche, we may receive, we will receive the second $10 million milestones and practically anticipate 30 days after the last fundamentation disclosure.
John: NDA filing also so it should increase let's say about 10% to 20% compared to compared to this year.
John: And with regards to the expected milestones as of today, what we know about.
John: All of the milestones related and connection with the transaction as you know because there are three milestones.
John: Expected from our Chinese partner <unk>, one when they have been.
John: Raised have been collected in 'twenty four and there is one milestones per tranche. So.
John: Our contemplated the second tranche of the financing in 25, so together with the second tranche. We may receive we will receive the second $10 million.
John: My students.
John: And practically a spade 30 days after the last randomization.
John: Disclosure.
Jean Volatier: Great, thank you so much.
Speaker Change: Great. Thanks, so much.
Operator: Thank you.
Speaker Change: Thank you.
Jacob Mekhael: Your next question comes from the line of Jacob Mekhael from KBC Securities, please go ahead. Hi there, and thanks for taking my question. Looking ahead to the top line data in the second half of next year, I was just wondering if you can share with us how soon after the last patient completes their treatment you will be able to share the results and perhaps how does that tie in with your cash runway being till the end of Q3 2026? So yeah, we were the last patient, last visit. I guess we'll need to wait for a couple of months.
Speaker Change: Your next question.
Speaker Change: Comes from the line of Jack up market from KBC Securities. Please go ahead.
Jack: Hi, there and thanks for taking my question.
Jack: Looking ahead to the topline data in the second half of next year I was just wondering if you can share with us how soon after the last patient complete their treatment you will be able to share the results and perhaps how does that tie in with your cash runway being till the end of Q3 2026.
Jack: So yes.
Jack: So once the last patient where the last patient last visit.
Jack: I guess, we'll need to wait for a couple of months.
Frederic Cren: to publish the top-line data. And then as we said, once we will have the last patient randomized, we'll have of course more clarity on when that date will be. And in terms of financing, once we raise the second tranche, which we expect to raise pretty soon, we'll be in a clear position to show that we have the means to deliver on our...
Jack: To top.
Jack: Top line the top line data.
Jack: And then as we said.
Jack: Once we will have the last patient randomized we love of course more clarity on when that update will be in.
Jack: And in terms of financing once we lap the rate the second tranche, which we respect to raise pretty soon.
Jack: In addition to show that we have the means to us.
Jack: Deliver all now are.
Jack: Clinical our clinical objectives.
Frederic Cren: Okay, thank you.
Speaker Change: Okay. Thank you and just maybe one more question if you can add.
Frederic Cren: And just maybe one more question, if you can perhaps just remind us on the deal with Hepatitis in Japan, what a phase three program would look like there and would that be entirely funded by your partner or do you have to contribute? Yeah, so, that's a very good, very good question. All our licensing in Japan, South Korea, and China, all the clinical development that are done locally are financed by our partners. In Japan, the current phase one and the phase three will be financed by EPALYST. We will have no impact on our finances. And similarly, the ongoing phase three in China is totally financed by CTTQ, SinoBank.
Speaker Change: Just remind us on the deal what happened is in Japan, where our phase III program would look like there and would that be entirely funded by your partner or do you have to contribute to that.
Speaker Change: Yes, that's.
Speaker Change: Very good very good question.
Speaker Change: All our licensing in Japan, South Korea and China.
Speaker Change: All the clinical development that are done locally are.
Speaker Change: Financed by our partners.
Speaker Change: In Japan, the current phase one into phase III will be financed by biocatalyst.
Speaker Change: No impact on our finances.
Speaker Change: Similarly, the ongoing phase III in China is totally financed by <unk>.
Speaker Change: Biopharm.
Rami Katkhuda: Thank you very much.
Speaker Change: Okay. Thank you very much.
Frederic Cren: Thank you.
Speaker Change: Thank you.
Rami Katkhuda: Your next question comes from the line of Rami Katkhuda from Lifesci Capital, please go ahead. Hey, guys. Thank you for taking my question.
Speaker Change: Your next question comes from the line of Robbie Kathy readout from lifestyle capital. Please go ahead.
Robbie Kathy: Hey, guys. Thanks for taking my questions I guess first how are you guys thinking about the design and timing of an outcome study where did the FDA require you to be with that prior to the filing of an NDA for Lenny.
Frederic Cren: I guess first, how are you guys thinking about the design and timing of an outcome study? Where does the FDA require you to be with it prior to the filing of an NDA per landing So yeah, the outcome studies. So, there's been... A couple of months ago, a new guideline from the FDA. It's very clear the study, the outcome study, needs to be underway at the time of NDA filing. So this is exactly the plan we have internally and that we have discussed with FDA, which is to run an outcome study inpatient with compensated cirrhosis.
Speaker Change: Yeah.
Speaker Change: So yes, the Alka study sold.
Speaker Change: It has been.
Speaker Change: Couple of months ago.
Speaker Change: New guidelines from the FDA.
Speaker Change: We cleared the studied the outcome study needs to be.
Speaker Change: Underway at the time of NDA filing. So this is exactly the.
Speaker Change: The plan, we have internally and that we have discussed with the FDA, which is to run.
Speaker Change: And outcome study in patients with compensated cirrhosis and this trial will be underway when we filed for.
Frederic Cren: And this trial will be underway when we file for. for NDA, and currently, you know, we plan to file for NDA in the first half of 2020.
Speaker Change: For NDA in currently.
Speaker Change: We plan to file for NDA in the first half.
Speaker Change: 20 <unk>.
Frederic Cren: Got it.
Frederic Cren: And I guess with enrollment nearly complete here, can you remind us of the powering assumptions in Native 3 for the combined endpoint? Yes, so the study is powered at 90%, 9-0, and we used the data from the Phase IIB, which as you know, is a six-month trial. and we have used what we believe is a... cautious approach, so we looked at the placebo effect, we have increased it. some percentages, and similarly, the effect size was reduced. a couple of percentages for both doses and that's what we use. for the powering at 90%. Why do we believe this is a prudent approach?
Speaker Change: Got it and I guess with enrollment nearly complete care can you remind us of the powering assumptions made at three four the combined endpoint.
Speaker Change: Yes so.
Speaker Change: The study is powered at 90% nine zero.
Speaker Change: And we used to the data from the phase two b, which as you know is a.
Speaker Change: Six months trial.
Speaker Change: And we have used what we believe it.
Speaker Change: Cautious approach so we looked at the placebo effect, we have increased it.
Speaker Change: Some percentages and similarly.
Speaker Change: The effect size was reduced.
Speaker Change: A couple of percentages for both dosage, that's what we used.
Speaker Change: For the.
Speaker Change: The powering at 90% wide.
Speaker Change: Why do we believe this is a.
Frederic Cren: It's because the Phase IIb was a very successful trial. We met the primary endpoint and also the key sectionary endpoint, but it was a six-month trial. And given the mechanism of action and also the data that has been published by our competitors, and if you look at data 12 or 18 months, you clearly see that with longer period of treatment, we believe the effect size of LANI will actually be greater than what we saw in the Phase IIb. And to answer your question, that's how we powered the study.
Speaker Change: Prudent approach is because the.
Speaker Change: The phase two B was very successful trials, we met the primary endpoint and most of the key points.
Speaker Change: But it was a six months trial and given the mechanism of action and <unk>.
Speaker Change: Also the data that has been published by by our competitors and you. If you look at data 12, or 18 months, you clearly see that.
Speaker Change: With longer periods of treatment.
Speaker Change: Belief.
Speaker Change: <unk> sighs of lending will actually be greater than what we saw in the phase II.
Speaker Change: To answer your question, that's how we powered the study.
Frederic Cren: Got it. Thank you very much.
Speaker Change: Got it thank you very much.
Operator: Thank you. As a reminder, if you would like to ask a question, please press star 1 and 1 on your telephone keypad.
Speaker Change: As a reminder, if you would like to ask a question. Please press star one on one on your telephone keypad.
Operator: We will now go to the next question.
Speaker Change: We will now go to the next question.
Jasmine: And your next question comes from the line of Ellie Moeller from UBS, please go ahead. Hi everyone, this is Jasmine on for Allie. Thank you for taking our question. So a question on the combination of Lani and STLT2 inhibitors. So going forward, what are your plans to study this? Do you think you'll need to generate more data here to support this combination used by physicians? And then secondly, how important do you think the mitigation of the weight gain with this combination is going to be to physicians and patients, particularly in the segment of MASH patients that are also obese?
Anna: And your next question comes from the line of Anna <unk> from UBS. Please go ahead.
Speaker Change: Hi, everyone. This is jasmine on for Elliot. Thank you for taking our question.
Speaker Change: So a question on the combination of <unk> and <unk> inhibitors. So going forward. What are your plans to study. This do you think you'll need to generate more data here to support. This combination use type question and then secondly, how important do you think the mitigation of the weekend with this combination is going to be the physicians and patients.
Speaker Change: Segment of Nash patients that are also obese.
Frederic Cren: Thank you. Thank you Alip.
Yeah.
Frederic Cren: On your first question, we have no plans to develop a fixed-dose combination lined up strategically to inhibit HIV. Why we did the study? Because I think it's important to have data that show that the metabolically healthy weight gain that you see in patient with... that in some patients treated with Lania, it's approximately one third to half of the patient that had gained weight. We have demonstrated that this weight gain is metabolically healthy. We've demonstrated that there is a plateau effect. So it's actually a weight gain that stabilizes after six to nine months of treatment. Nevertheless.
Speaker Change: Thank you Ali for the on the on your first question, we have no plan to develop a fixed dose combination <unk> two inhibitors.
Speaker Change: Why we did the study.
Speaker Change: Because I think it's important to web data that.
Speaker Change: Sure.
Speaker Change: Z metabolically LC weight gain that you see in patient with the.
Speaker Change: That's been some patient treated with lineal approximately one third to half of the patients gain weight.
Speaker Change: We have demonstrated this weight gain is metabolically LC.
Speaker Change: We have demonstrated that there is a plateau effect. So it's actually a wet gate that stabilizes after six to nine months of treatment. Nevertheless.
Frederic Cren: you know, some patients. probably will be looking for. They can give you help. the weekend. That question with that study. We also believe that the data that we are generating right now in the phase 3 with patients with GLP-1. will help show that. actually a very good combination. at the GLP1 to learn to retain the advantages of both drugs, but also mitigate the weight gain. We also be a... a nice combination to address the weight. Thank you.
Speaker Change: Some patients.
Speaker Change: Probably we'll be looking for.
Speaker Change: Sure.
Speaker Change: The approach.
Speaker Change: Size, the lifestyle or beside.
Speaker Change: A diet to control this weight gain.
Speaker Change: We wanted to show that if you combine lending with IAG to inhibitor you managed to retain the benefit of the both drug.
Speaker Change: And.
Speaker Change: At the same time mitigate.
Speaker Change: The weighted that we're showing with that study.
Speaker Change: Also believes that.
Speaker Change: The data.
Speaker Change: We are generating right now.
Speaker Change: <unk> III with patient with GOP one.
Speaker Change: We'll show that.
Speaker Change: That's actually very good.
Speaker Change: Combination.
Speaker Change: Adding <unk> to allow me to retain the advantages of both drive but also mitigate the weight gain.
Speaker Change: B.
Speaker Change: Nice nice combination to address the weight gain.
Speaker Change: Yes.
Speaker Change: Thank you.
Frederic Cren: There are currently no further questions. I will hand the call back to Frederic. Thank you, operator, and thank you, everybody, for attending. Great set of questions. You have understood that our next milestone is the end of randomization. It's going to be, of course, for us. strong event but also I think for the for the MASH community because it you know it starts a clock for an important phase three that we'll read out and when I say important because if you look at the profile of Lanny we really have a drug that can be a game changer for for patients that are suffering from from MASH.
Speaker Change: There are currently no further questions I will hand, the call back to Fredrik.
Fredrik: Thank you operator, and thank you everybody for attending Great set of question do you have understood that our next milestone is the end of randomization, it's going to be of course for us.
Fredrik: Strong event, but also I think for the for the mass community because it starts the clock.
Fredrik: Sure.
Fredrik: In phase III that will readout.
Fredrik: When it's important because if you look at the profile of planning, we really have a drug that can be a game changer for for patients that are suffering.
Frederic Cren: With that I really thank you for for your strong support over 2024 and as I said we have ahead of us I think a very exciting 2025. I'm sure we will have several opportunities to discuss. throughout this year. Thank you very much. Thank you.
Fredrik: Suffering from how much with that I really thank you for for your strong support of over 2024 and as I said, we are ahead of us.
Fredrik: So very exciting 2025.
Fredrik: I'm sure we will have several opportunities to discuss.
Fredrik: Throughout this year, thank you very much.
Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.
Fredrik: Thank you. This concludes today's conference call. Thank you for participating you may now disconnect.
Fredrik: Okay.
Fredrik: Okay.
Fredrik: [music].
Fredrik: Okay.
Fredrik: Okay.
Fredrik: Yes.
Fredrik: [music].
Fredrik: Yes.
Fredrik: [music].
Fredrik: Yeah.
Fredrik: [music].