Inventiva S.A. Price & Performance (IVA)

Thank you, operator. Good morning, good afternoon, everyone. Thank you for joining us to discuss our twenty twenty four full year financial results. We issued a year press release this morning and the webcast will be available in the Investors section of our website. I want to remind everyone that various statements that we may make today during this conference call and during the Q and A session will include forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Joining me on this call is Jean Volatier, our Chief Financial Officer and Pierre Rocha, our our Financial Rocha, our CFO and cofounder. 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 and A. So on the highlights for '24. So '24 goes 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 ibranor and with the tremendous support and commitment of our clinical trial site, we have been able to close screening for our phase three NATE3 early January twenty five.

We can therefore confirm that we target the completion of recruitment in H1 twenty twenty five as previously guided. This will start the countdown to our top line result at expected in the second half of twenty twenty six, making of lanifibranor the second oral drug that could be approved in The United States in mash. In addition to be very close from reaching completion of enrollment, in 2024 and in the first quarter of twenty twenty five, we had three data monitoring meetings with positive recommendation to continue NATE3 without modification to protocol. Most recent one took place in February 2025 during which the safety data of more than 1,000 patients randomized in 83 were reviewed. 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 in the commercialization of lanifibranar. 2024, we also reinforced our clinical dataset for lanifibranor with the publication of the positive results of Legend our combination proof of concept trial with lanisibronor and mPACT empagliflozin in patients with NASH and type two diabetes. The primary endpoint was met with a statistically significant reduction HbA1c with lanifibranor alone and in combination.

Insulin sensitivity was improved consistent with other study and additional improvement was observed in combination with empagliflozin. Markets of liver injury were significantly improved and this improvement was solely driven by lanifibranar. The second goal of this trial was to look at the potential of the weight gain when adding an FG2 FGLT2 inhibitor to lanifibranor. We were very pleased to show that the combination of Lanin with empagliflozin completely mitigate the weight gain. Furthermore, Lanifibranor alone and in combination leads to a shift towards metabolically LCRD plus tissue. Finally, meta analysis data suggest that GLP-one have a similar effect when combined with PPAR. This study is particularly significant given the high prevalence of type two diabetes among patients affected by NASH. We are convinced that the profile of Lanin is ideal to treat patients with advanced fibrosis and diabetes, a patient population which is hard to treat and high risk to progress to cirrhosis. We're looking forward to looking more in-depth at our learning effect when combined to other drugs, particularly GLP-one as we have randomized approximately fifteen percent of patients of on GLP-one in the Phase three study. This year, we also announced that our partner Epallis has launched the clinical development of lanifibranor 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 Epyalis and in China with CTQ, lanifibranor will be ideally positioned to potentially become the leading oral drug in NASH in these two important geographic areas. Looking now at the organization and at the governance, are committed to make Lanny a success story for patients. And this is definitely a priority for Inventiva. Are focusing on change and challenging all our resources and efforts into achieving this goal. As part of this process, we are reinforcing our development team to ensure ensure that we're fully prepared for regulatory filing and the potential commercial launch. In February, following a strategic review, we announced the decision to focus all of our resources to the development of Lanik. Unfortunately, this decision comes with a stop of all preclinical activities not related to Lanny, and would lead to a reduction of approximately 50% of our workforce. I want to emphasize that this was not an easy decision Our research team has been to Inventiva for the past twelve years and has been instrumental in the development of Lanny. We are currently in negotiation with the Worker Council And while I'm unable to comment further at this stage, we are committed to working together through this transition.

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 Andre Turin, the President and CEO of the Boston based biotech Matchpoint Therapeutics. And former Global Head of Business Development at Sanofi. In December, Srini, the founder and partner of Samsara Capital joined us. And we also nominated Mark Prozanski 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 mesh market over the last years. Marc brings us, of course, a wealth of experience in both NASH field 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 Lanny to [indiscernible] driving meaningful progress in the treatment of NASH. Now, finally, before I hand over to Jean, financial situation. 2024, we successfully closed the on several dilutive and non dilutive financing. Operation, raising approximately a total of $184,000,000 in gross proceeds. Most of these amounts come from our three tranche financing of $125,000,000 each, The financing came from existing and trusting investor and especially new investors.

We received the first tranche in 2024, will be eligible to receive the second tranche following the announcement of end of randomization. We should have then met all operational condition precedent necessary this second tranche. Let me now turn it 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, as said, we have issued our press release. Covering the full financial results for the fiscal year 'twenty four. Of course, I will provide you with key highlights. Happy to answer more detailed questions during the Q and A time.

So I start with the cash position and cash flows.

So we have reached at the end of twenty twenty four, 96,600,000.0.

Of cash position versus CHF 36,000,000 at the December '23. Therefore, a net positive variance of close to €61,000,000 as a matter of fact, this represents half a year roughly of annual OpEx. Key factors, as said by Frederic, is of course US184 million dollars €170,000,000 of raising under different operations, dilutive and non dilutive. The fourth principle are of course the raising of the second tranche of 25,000,000 drawn in January 24 from the European Investment Bank The second in July 24 was the raising of 20,100,000.0 with the issuance of YLTDs. The biggest one, of course, related to the up to $348,000,000 finance structured transaction announced in October 1424 represent €116,000,000 net proceeds received during the fourth quarter. And eventually, we received also the first milestone of CTQ, our [indiscernible] Our Chinese partner as part of the financing in October. And you remember that there are three tranches three milestone related to this transaction. Also we can come back on that. So therefore, we have confirmed we do confirm the cash runway guidance disclosed previously, meaning we can operate until September 25 without the contemplated second tranche of the financing. And after the contemplated second tranche of the financing, we should reach September 26.

Let's talk now about the key figures of the profit and loss account. So we have recorded revenues in 2024 of €9,200,000 and it refers with to the milestones I talked about earlier with CTQ Synovio Pharm, compared to 17,500,000.0 on the same period in '23. The other income line is stable at $55,000,000,500,000.0 compared to 5,700,000.0. It represents as usual essentially the R and D French tax credit. Of course, the most important line is the R and D expenses. We still represent more than 80% of our global operation expense, so amounting to €19,900,000 in 2024 compared to 110,000,000 in 2023, showing a decrease 17%, which was due to the delays we have to face in '24. To be noted that as announced during the second half of 'twenty four, these R and D expenses have started to increase again following the restart of the patient recruitment in ATTEA-three. The marketing and business development line is still not significant at 2,000,000 stable compared to 23,000,000. But with the approach of the end of the Phase three, expected to increase in the near future. Because we start preparing the NDA filing and the commercialization capabilities. In terms of G and As, reaching €15,800,000 for '24.

Compared to 13,800,000.0 in '23, 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 it has we have a slight increase in particular in other legal and compliance fees. There is a rather unusual amount, as you can note it in the net financial loss million compared to CHF 5,000,000 in 'twenty three. Two items, one off items of €33,000,000 which is related to a specific IFRS retreatment, non cash related to the fair value of second tranche to realized, we expect very soon. And has to be treated as a derivative instruments since considered as a call option instruments. And we have also this year 12,200,000.0 of noncash interest and related to the loans. And related to the royalty certificates amortization. Bottom line, the company's net loss for the full year established at 184.2 compared to 110,000,000.4 in 2023. I will now turn it over to Fredrik for the conclusion and Q and A. Thank you for your attention. So we've made important improvements significant strides and I'm confident that we have a tremendous ahead of us with Lanifilmranor. If you look at 2025, we anticipate announcing the completion of randomization and the release of the tranche of $127,000,000 our Structorig financing.

Today, we are the only Phase III that is recruiting currently and evaluating an oral liver targeted drug candidate. We have a robust data set, including our Phase two in which we observe an improvement of one stage fibrosis in just six months of treatment. The demand for MArS treatment is clear. The available treatment options are still limited today to a single mechanism of action. We believe that given the heterogeneity of the patient population and the broad prevalence of NASH, having multiple oral treatment options would be a game changer for patients. Thank you, and we are now open We now open the floor for questions.

Thank you. Star one and one on your telephone and wait for your name to be announced. Will now go to our first question. One moment please. And your first question comes from the line of Ritu Baral from TD Cowen. Please go ahead. Hi everyone, this is Nicole online for Ritu. Just a quick question. Are the background doses, for the patients on background doses of -1s, 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 SGLT2, if you like. Oh, go ahead. You know both. Sorry, go ahead. GLP-one is mostly antidiabetic dosing. It's not only semaglutide, it's it's other well, semaglutide is included, but you have also other GLP-one agonists. And by the top of my head, you had between six percent to eight percent of patient on FGLT two inhibitor. At baseline.

Great. Thank you.

Thank you. We will now go to the next question. And your next question comes from the line of Shanhama from Jefferies. Please go ahead.

Hi. Thank you for taking my questions.

So I know you expect to complete enrollment within the first half of this year. But what's your level of confidence in randomizing that last patient and main cohort by 38 to to secure that hundred and €16,000,000 capital increase? And then secondly, given it's likely you have cash, including this second tranche to just 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 to have a partner. What's the level of interest here from pharma to be able to close a deal as quickly as possible? Thank you.

So, many questions. So, the first one on the confidence of recruiting before the 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 sufficient patient 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 pyrim with the assumption of the of the SAP. The average screening period is between twelve to ten to twelve weeks. And so, we feel very optimistic that we'll meet that April objective. On your question about partnering, there is a lot of interest in the mass market. I would say finally, given you know that we've been going through a series of, you know, failures in the field. And, luckily, some companies have had have reported positive data. And more importantly, Madrigal Resmeterone drug has been approved. There is no need of biopsy to prescribe it. The commercial launch has been very solid and they're definitely in the direction of the blockbuster potential. So, of course, that drives a lot of interest.

We believe we have very strong package. We are the only oral drug currently in phase three development. Most likely, once we will announce the end of complete end of enrollment. We can reassert that will be the next oral drug to be potentially approved? And given the results we have had in the Phase 2b, we feel that's really strong you know, the the the commercial success of of nanofibranor. On the, how we manage our resources, of course, [indiscernible] 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 Lanny. And of course, while we do that, we continue evaluating all options to secure the funding needed to to keep to to achieve our objective, which is to execute the clinical trial file for NDA, and commercialize the commercialize Lamy first in The US and then in the European community.

Thank you.

Thank you.

Your next question comes from the line of Annabel Samimy from Stifel. Please go ahead.

Hi, thank you for taking my question.

Just 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 mass market appears to be forming the first approved treatment. The profile of 20 ones are emerging and there's additional data emerging on incretins being able to drive mass resolution Has the way you thought you think about the market and the population in Atlanta Lannie would be most appropriate for change at all? And how do you see this market fragmenting with the potential introduction of Lanny?

So, thank you, Annabel, for this question. So, a very interesting thought. To your first question, can 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 examination that are on the protocol. So during that period, we need to do all the lab tests. 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 twelve months, twelve months, weeks And then once a patient is randomized, there is an appointment he needs to show at the hospital. And then he is 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 the patient present himself to an appointment or the site is not reactive enough, And so this period of time to screen and randomize a patient is overdue. We can screen fail the patient automatically. That's why he's confident that we will randomize the last patient as guided before the first half of H1 [indiscernible] On your second question on where we see Lanny play a role in the market shape.

As I said before, Madrigal launch really showed that there is a a huge market. And even more so because we believe Magic Gold 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 a commercial marketing of Novo will help enlarge the market. Where we see Lanny work clearly and 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 of type two diabetes. This is a a large population. We estimate that more than fifty percent of patients with MASH have type two diabetes, the F2F3 population. This is a population which has a fibrosis progression that is faster than the overall population. They are more difficult to treat. The profile of lining where we can see fibrosis reduction in six months We can see a resolution of NASH and especially a strong insulin sensitivity activity with 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 MPPAR is a well known mechanism with endocrinologists and diabetologists.

In The US alone, you have close to million prescriptions of pyo. Pyo is a as you know, all the PPAR gamma. Let's call it the first generation 6,000,000 scripts every year written in The US. Which really demonstrate that this diabetologist endocrinologist are very familiar, very used to prescribe PPARS mechanism. And so there will be we think attracted by the profile of lanifibranlar.

Fantastic. Thank you very much. Thank you.

Your next question comes from the line of Ed Archer from H. C. Wainwright and Company. Please go ahead.

Hi, good morning everyone. Thanks for taking my questions. Just a couple from me.

So I'm just wanted to get your thoughts, on R and D expenses throughout the year considering both the impact of the recent reduction in workforce and the elimination of the early programs but also as well the full enrollment of native three 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.

John, do want to take these questions? Sure.

So for the profile, let me say, of the R and D expenses this year, as I said, decreased by 17% because we know we have to face some some operational problems. But we have restarted the recruitment in Q2. So the decrease versus last year and versus budget also, which was basically something like €20,000,000 represents this momentum for 2024. If we talk about 01/2025, 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 Felix said also, we start to prepare the commercial capabilities. 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 in connection with the transaction. As you know, because there are three milestones expected from our Chinese partner, CTQ, one have been raised, have been collected in 'twenty four. And there is one milestone per tranche. So we are contemplating the second tranche of the financing in 2025. So together with the second tranche, we may receive we will receive the second $10,000,000 milestone And practically, is paid thirty days after the last randomization.

Disclosure. Great. Thank you so much. Welcome.

Thank you.

Your next question comes from the line of Jacob Makil 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 twenty twenty six?

So yeah, we want the last patient to have the last patient last visit I guess we'll need to wait for a couple of months to publish the top line data. And then as we said, once we will have the last patient randomized, we'll have course, more clarity on when that date will be. And in terms of finance once we left the rate of second tranche, which we expect to to raise pretty soon, we've been in a clear position to show that we have the means to deliver on our you know, clinical clinical objective.

Okay. Thank you. And just maybe one more question if you can. Perhaps just remind us on the deal with Hapitalis in Japan. What a Phase III program would look like there? And would that be entirely funded by your partner or do you have to contribute to that?

Yeah. So that's a 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. So the in Japan, the current phase one and the phase three will be financed by by Epelist. We will have no impact on our finances. And similarly, the ongoing Phase three in China is totally financed by, by CTTQ Sinobiopharm. Okay, thank you very much.

Thank you.

Your next question comes from the line of Rami Kathuda from LifeSci Capital. Please go ahead.

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 does the FDA require you to be with it prior to the filing of an NDA for Lanny?

So yeah, the outcome study. 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 in patients with compensated cirrhosis. And this trial will be underway when we file for for NDA. And currently, you know, we plan to file for NDA in first half of 'twenty seven.

Got it. And I guess with enrollment nearly complete here, can you remind us of the powering assumptions in native three for the combined endpoint?

Yes. So the study is powered at 90%, nine zero, And we used the data from the phase 2b 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. By some percentages. And similarly, the effect size was reduced by a couple of percentages for both doses. That's what we used for the powering at 90%. Why do we believe this is a prudent approach is because the phase 2b was a very successful trial. We met the primary endpoint and also the key secondary endpoint. It was a six month trial, and given the mechanism of action, And also the data that has been published by our competitors, if you look at data twelve or eighteen months, you clearly see that with longer period of treatment, we believe the effect size of Lanny actually be greater than what we saw in the Phase 2b. To answer your question, that's how we powered the study.

Got it.

You very much.

Thank you. We will now go to the next question. And your next question comes from the line of Ellie Merler from UBS. Please go ahead.

Hi, everyone. This is Jasmine on for Ellie. Thank you taking our question.

So a question on the combination of LANI and SGLT2 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 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 NASH patients that are also obese. Thank you.

Thank you, Ellie.

So the on your first question, we have no plans to develop a fixed dose combination [indiscernible] Why we did the study? I think it's important to have data that show that the metabolically healthy weight gain that you see in patients with that in some patients treated with lanyard, it's approximately onethree to half of the patients that gained weight. We have demonstrated that this weight gain is metabolically healthy. We have demonstrated that there is a plateau effect. So it's actually a weight gain that stabilizes after six to nine months of treatment. Nevertheless, you know, some patients probably will be looking for an approach besides the lifestyle or beside the diet, to control this weight gain. So we wanted to show that if you combine lining with an AG2 inhibitor, you manage to retain the benefit of the both drug and at same time mitigate the the weight gain. That that was shown with that study. We also believe that the data that we are generating right now in the phase three with patients with GLP-one will help show that that's actually a very good combination adding GLP-one to Lanit to retain the advantages of both drugs, but also mitigate the weight gain.

We also be a nice combination to address the weight gain.

Thank you.

There are currently no further questions. I will hand the call back to Fredrik 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 a strong event, but also, I think, for the the mass community because it, you know, it starts the clock for an important phase three that will read out And when I say important because if you look at the profile of Lanny, really have a drug that can be a game changer for patients that are suffering from With that, I really thank you for your strong support over 2024. And as I said, we have ahead of us I think, very exciting 2025. I'm sure we will have several opportunities to discuss throughout this year. Thank you very much.

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.