Inventiva S.A. Q4 FY2025 Earnings Call

Good day, and thank you for standing by. Welcome to the Inventiva Full Year 2025 Financial Report Webcast and Conference Call. Operator instructions were provided. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, David Nikodem, Head of Investor Relations. Please go ahead.

Good morning, good afternoon, everyone, and thank you for joining Inventiva's Full Year 2025 Financial Results and Business Update. Our press release was issued yesterday evening, and this webcast and slides will be available in the Investors section on our website following the call. Joining us on the call today are Andrew Obenshain, Chief Executive Officer; Jean Volatier, Chief Financial Officer; and Dr. Jason Campagna, Chief Medical Officer and President of R&D. I would like to remind everyone that statements made during today's conference call and during the Q&A session may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Please refer to Slide 2 of the slides and our SEC and AMF filings for a discussion of associated risks. These statements reflect our views as of today and should not be relied upon as representing our views at any later date. With that, I will now turn it over to Andrew, starting on Slide 3. Andrew?

Thank you, David. Good morning, good afternoon to everyone, and thank you for joining us. Since joining Inventiva 6 months ago, I've been struck by the depth of scientific conviction behind lanifibranor and the dedication of this team. Today, every resource, every decision and every member of this team is now aligned behind a single objective, advancing lanifibranor towards approval for patients with MASH. Let me start with our main focus, our global Phase III clinical trial NATiV3. Enrollment was completed in April 2025 and represented a landmark operational milestone for this company. Today, we are updating the expected timing of our top line readout to Q4 2026, reflecting the disciplined sequencing of our clinical and biostatistical milestones. We believe the data from the NATiV3 trial, if positive, has the potential to carry weight with regulators, physicians and most importantly, with patients. And we believe we are running this program with the rigor and precision all stakeholders deserve. On our pipeline and organizational focus, in the first half of 2025, we made the strategic decision to concentrate all of Inventiva's resources on lanifibranor and MASH. As part of this plan, in Q4 2025, we sold our global rights to odiparcil to Biossil and we may receive up to $90 million of potential regulatory and commercial milestone payments, as well as potential high single-digit royalties on future net sales if approved. While this transaction frees up our internal resources to fully focus on lanifibranor, we are pleased that odiparcil has found a new home where its development can continue, potentially offering patients with MPS VI an opportunity for treatment. At the same time, we strengthened our leadership team to align with the level this opportunity demands. Jason Campagna joined as CMO and President of R&D. Martine Zimmermann joined as new EVP and Head of Quality and Regulatory Affairs; and Nazira Amra joined as our Chief Commercial Strategy Officer. We are building towards launch in a lean and targeted way, advancing our readout and NDA preparations while laying the early groundwork for commercialization in anticipation of potential approval of lanifibranor. And the opportunity is real. MASH has been underdiagnosed and undertreated for too long, but that is changing. More patients are being identified, more being diagnosed and entering care. Awareness is growing, screening is improving and metabolic disease is finally getting the attention it deserves. The numbers tell that story clearly. There are an estimated 18 million people in the U.S. living with MASH, but only around 10% have been diagnosed, and that number has grown by 25% compared to 2024 estimates. Among those diagnosed with clinically actionable F2 or F3 disease, only around 40% are currently under the care of a treating physician. So while diagnosis rates are improving and the market is evolving, far too many patients with significant fibrosis remain without the care they need and face a real risk of progression to cirrhosis and liver failure. If our NATiV3 trial can replicate the 18% fibrosis improvement seen in Phase II, we believe lanifibranor could be well positioned as a potential best-in-disease oral therapy with significant commercial impact. Ultimately, our goal is to make a meaningful difference for patients and that is what drives everything we are doing. I will now turn the floor over to Jason, who will give a brief update on lanifibranor, our differentiated oral anti-fibrotic, and a potential new treatment option that we believe addresses the remaining unmet medical needs in MASH.

Thank you, Andrew. Good morning and good afternoon, everyone. Let me start by reminding you of the mechanism of action and the development pathway of lanifibranor. Lanifibranor is a small molecule designed to induce anti-fibrotic, anti-inflammatory and beneficial vascular and metabolic changes by activating all three PPAR isoforms—alpha, delta and gamma—in a balanced manner. This broad mechanism of action is designed to target the hepatic and extrahepatic drivers of MASH simultaneously and in one oral therapy. Lanifibranor was the first asset to achieve statistically significant improvement in the composite endpoint of both fibrosis improvement and MASH resolution in our Phase IIb NATIVE trial, after just 24 weeks of treatment with a favorable safety and tolerability profile. On the basis of these results from our Phase IIb the FDA granted lanifibranor breakthrough therapy and fast track designations. NATiV3, our pivotal Phase III clinical trial was designed to confirm and extend those findings in a larger, more diverse global population over 72 weeks and is intended to provide the data to enable successful marketing authorization in the United States and Europe. NATiV3 is a randomized, double-blind, placebo-controlled trial in patients with biopsy-confirmed MASH and stages F2 or F3 fibrosis, the core of the MASH treatment population. Those with significant disease burden and a high risk of progression to cirrhosis, liver failure and liver-related mortality. We specifically chose a clinically meaningful primary endpoint for NATiV3, fibrosis improvement and MASH resolution. And at 6 months in our Phase IIb the 1,200-milligram dose of lanifibranor showed a 24% treatment effect. NATiV3 was also deliberately designed to mirror the patient population of our positive Phase IIb and the real world as it exists today. A meaningful proportion of our patients have type 2 diabetes and other metabolic comorbidities, and a number are on background GLP-1 and/or SGLT2 inhibitor therapies, mirroring the patients physicians actually see in their clinics, which we believe will ensure that we generate clinically meaningful data to support both NDA and MAA submission. In April of 2025, we completed enrollment, exceeding our original targets with over 1,000 patients in the main cohort and an additional 410 patients with MASH and fibrosis stages F1 through F4 in an exploratory cohort. We anticipate sharing the top line results of our pivotal Phase III trial in Q4 of this calendar year, a moment, I believe, will be significant for the field and for the patients who need new treatment options. I will now turn the floor over to Jean for our financial review.

Thank you, Jason. Good morning and good afternoon, everyone. So yesterday evening, we issued our press release with our full financial results for the year ended December 31, 2025. I will focus on the highlights. As of December 31, 2025, we held EUR 230.9 million, close to EUR 231 million in combined cash, cash equivalents and short-term deposits. This position was built by two significant financing events in 2025. First, the execution of the second tranche of our 2024 structured financing in May generating approximately EUR 108 million in net proceeds. And second, our U.S. registered public offering in November generating approximately EUR 139.4 million in net proceeds. We estimate that we are funded beyond our anticipated NATiV3 readout. Based on our current operating plan and cost structure, we estimate that our cash runway extends to the middle of Q1 2027 and to the middle of Q3 2027, assuming the full exercise of our tranche 3 warrants, which could generate up to an additional EUR 116 million. We confirm this way the cash guidance provided earlier. Our R&D expenses for the full year were EUR 87 million, primarily reflecting our pipeline prioritization and, to a lesser extent, the completion of NATiV3 enrollment in April 2025. Marketing and business development spend increased to EUR 5 million primarily due to expenses related to a planned pre-commercial investment as we prepare for a potential launch of lanifibranor if approved. G&A expenses of EUR 47.9 million include approximately EUR 20.3 million of noncash share-based compensation tied to the governance and organizational transition we implemented this past year. I will now turn the floor back to Andrew for closing remarks.

Thank you, Jean. Inventiva enters 2026 well-funded, operationally focused and ready for a consequential chapter in this company's history. NATiV3 is fully enrolled. We've built a leadership team with deep medical, regulatory and commercial expertise, and our regulatory and commercial readiness work is progressing in parallel. Our anticipated top line readout in the fourth quarter of this year represents a genuine inflection point, not just for Inventiva, but for the millions of patients living with MASH, who still have no adequate treatment options. We are truly executing with the discipline and urgency this moment demands. Thank you for joining us today. We will now open the floor for questions. Operators, please go ahead and provide instructions for the Q&A session.

Operator instructions were provided. We will now take our first question. And our first question for today comes from the line of Seamus Fernandez from Guggenheim.

Just a few quick questions. First, can you update us on how the performance of the trial has been in terms of dropouts? I know that there were some requirements from the tranches that were coming in that were successfully completed, but I just wanted to get a sense of where the dropout rate was as you were kind of wrapping up enrollment. Second question is, can you help us understand how you're thinking about the performance of the 800 versus the 1,200-milligram dose in terms of both weight gain and then ultimately on fibrosis? Is the sort of change from a more typical 12-month endpoint to the 18-month endpoint geared to have the 800-milligram dose catch up to the 1,200 but also manage the potential tolerability or weight gain issues? And then the last question is just what you're seeing in terms of the overall market interest. Madrigal continues to see very strong uptake in the U.S. How are you thinking about the opportunity to compete with Madrigal? What do you think is the threshold necessary? Andrew, you mentioned 18%. Just interested to know if you think 18% is the threshold where the impact is going to be substantial or is that more reference to the powering of the study?

So, good morning, Seamus. Thanks for the questions. I'm actually going to take your third one first and then hand the first two over to Jason. So yes, just to be really direct, we think that if we replicate the Phase II trial and have an 18% effect on fibrosis, we have an excellent drug. That is the clearing efficacy that we need in order to have a very attractive market opportunity. We continue to see a lot of market growth, thanks to the entry of the two approvals and a lot of awareness around MASH. And there still continues to be unmet need, especially we see in that F3 diabetic patient population, where we think there'll be a very good entry point for lanifibranor. And then at an 18% fibrosis effect with our HbA1c lowering, we have a very good profile for that. Let me then turn the question over to Jason on the dropouts and what we've last discussed publicly there, and then the second question about the 800 catching up to the 1,200 milligram dose.

Seamus. So let's take the first one. You are correct that as part of the structured financing from 2024, there were covenants around the release of follow-on tranches that the early termination rate for the trial needed to be below 30%. That number was selected because the original powering analysis for the trial allowed for up to a 30% dropout rate. So that was the metric that was used, and we have disclosed publicly at the time of both the first and the second tranche release, which would have been in April of 2025, that we were below that threshold. I think now that we're tightening the guidance to Q4 of this calendar year, we were able to confirm we are well within that range and feeling quite good about where we've landed and are reaffirming that the trial is well powered to detect the primary endpoint with the size of the trial that we have and the early terminations that we've seen. So the second question you asked about the two doses, I think you're landing in the right mix of elements that are important to us. We agree with you that in theory, with additional time just because of the way PPARs work and the biology of the liver, that the 800-milligram dose will have time to catch up to the 1,200. It was already quite a good dose back in NATIVE, as you recall. But six months is relatively thin for a PPAR, which is a transcriptional modulator, to do its work. So the idea that you could see a deeper effect with that 800-milligram dose at 18 months is very reasonable. But I think where you're landing around the potential dose responsiveness versus tolerability concerns, that is also very important to us. Take weight gain, which you mentioned: weight gain can be a traditional PPAR gamma-mediated fluid retention event, and we know that fluid retention is highly likely to be dose dependent just from what's been shown with other PPAR agonists and our own data from NATIVE. So we think the potential to have strong efficacy with both doses, which we were able to show in NATIVE, but that may have a different tolerability profile at the lower dose could be meaningful for patients. So it's our hope that both will be positive, and we'll have that opportunity to discuss that with regulators.

We will now take our next question. Our next question for today comes from the line of Yasmeen Rahimi from PSC.

This is Dominic on for Yas. First, we know that NATiV3 is a very large data set. As we're getting closer to top line data in Q4, what are some of the quality control protocols going on in the background to analyze the biopsy samples and what procedures are in place to ensure timely and thoughtful assessment of these biopsies? And then our second question is, can you just talk or help us understand if you had any recent safety monitoring committee activity? And are you seeing anything on a blinded basis on the safety profile? Any color there would be helpful.

Good morning, Dominic. So two questions. Let me take the second one first, and the first one over to Jason. Just on safety monitoring, there are periodic monitoring committee meetings every six months. You would know if they had said anything. Other than that, we really can't say anything about those meetings. Go ahead, Jason, on the biopsy.

Yes. Thanks, Andrew. Dominic, so quality control and biopsy. Let me start by saying that the team we have here is outstanding. The clinical operations and the clinical development team have been immersed in the world of MASH clinical trials for the better part of a decade. This is something they know well and we carried that expertise forward. You can think of biopsy quality control around three issues. First, are we protecting the patient at the bedside and doing the right things. Second, are we capturing the biopsy according to standard practice—length of the biopsy, overall quality of the core. There are measurements and checks that determine whether the sample meets quality criteria. We have reviewed all of those and continue to do so right up until we get to last patient, last visit later this year. And then lastly, when the slides are sectioned prior to being read, there's a quality control step that looks at what actually gets made onto the slide. At that point we are blinded to treatment assignment, but there is a quality check in terms of whether the reviewers are staying on time and on track reading biopsies in the paired manner specified both in the protocol and the analysis plan. I like the teams that we have in front of it and more importantly, I think that they are doing exactly the right work to keep us on track.

Our next question for today comes from the line of Ritu Baral from TD Cowen.

I want to drill down a little bit more upon final powering. You guys disclosed the over 1,000 final patient number—I think it's 1,009 and the 90% powering. What's the effect size that that powering is for on the primary combined endpoint? And what are your expectations for potential movement around placebo of that, I think it was 7% at the six-month final primary endpoint? And then I have a follow-up on market expectations around that F3 diabetic population that was mentioned.

Thank you, Ritu. Jason, why don't you go ahead and answer that question?

On the first one, we are not guiding to the actual effect size, but I can reiterate what we have been saying. With the sample size of over 1,000 patients, we are powered to over 90% on the primary composite endpoint of fibrosis improvement (one stage or more) and MASH resolution. That composite endpoint has shown a higher placebo response than we saw in NATIVE, which as you know was 7%, and it also assumes a smaller treatment effect than we observed in NATIVE for the 1,200-milligram dose. So that means the overall effect size we are powered to is smaller than the Phase II effect— a more conservative view than the actual Phase II data. Alongside our comfort with the early termination rates we have, we feel very good that the trial is structurally sound and will give us an answer one way or the other: did lanifibranor work at the 1,200-milligram dose? The testing is hierarchical. We can't get to the 800 unless the 1,200 is positive. But that is the core question. We think the trial was well set up to deliver an answer to that question that is well powered and highly confident. On placebo response: individual endpoints of fibrosis alone or MASH resolution alone can be noisy. That said, the composite endpoint—the primary endpoint of NATiV3—has shown less placebo response across sponsors. Biologically that makes sense: it is uncommon for a patient to both improve fibrosis stage and also resolve MASH spontaneously. What the 7% in NATIVE suggests is that in the real world that's rare, and we expect the placebo response on the composite to remain very low. We've seen precedent for that and that's our expectation for the trial we're running.

Very helpful. And then, Andrew, a question on how you guys and your own market research is viewing that F3 diabetic population. Do you have an approximate patient number? How is the diagnosis rate in that population changing versus the overall MASH population given the ADA focus on MASH and its messaging to diabetologists?

Thanks for the question, Ritu. In terms of size, there's about 375,000 patients total F2 and F3 under treatment or in care right now. The largest segment is the F3 diabetic patient population: 55% to 65% of the patients are diabetic, and the split is roughly 50-50 between F2 and F3 in our market research. So that patient population is quite large overall. In terms of growth, we don't have granularity down to that segment, but anecdotally F4 is one of the fastest-growing segments. Diagnosis rates are increasing quite a bit overall for F2, F3, F4 due to new entrants into the market, so they are growing proportionately with the market in that segment.

To that point, Andrew, can you tell us of the 410 expansion cohort patients, how many are F4? Do you know at this point?

I'll pass that question.

Confirming you're talking about the exploratory cohort, correct? We do have F4s in that cohort. They would have screen-failed for the main cohort by histology or other lab values. They represent a range of compensated F4—from no evidence of portal hypertension to evidence of clinically significant portal hypertension. That data will be quite interesting to us. We're not yet guiding on when we'll have an opportunity to get those data out. It's unclear right now if we will include them in the top line per se or in the weeks that follow. As we get closer to top line data, we should be guiding on that more tightly.

Our next question today comes from the line of Thomas Smith from Leerink Partners.

Just wanted to follow up on that F4 population. I know you're capturing some of those patients in the exploratory cohort. Can you expand a little bit on what you hope to learn from that exploratory cohort and how you're thinking about planning for the outcome study in F4s pending the NATiV3 data and perhaps how some of those plans could change? We know we're going to get F4 outcomes data for Rezdiffra also in 2027. So some interesting timing around that data set relative to when you're planning on starting this F4 outcome study.

Thanks for the question, Tom. Jason, go ahead.

There's a lot there. Let me make sure I cover it. First, what we expect to learn from the cirrhotic population in the exploratory cohort: above all, safety of lanifibranor in that population. If you're going to bring a new therapeutic into a sicker population, you want to have safety headroom. We have approximately 75 patients in that cohort, so safety is the primary objective. Second, while that cohort is not systematically tracked for efficacy, we do anticipate having data on liver function tests, transaminases and other measures that will point directionally toward whether the drug is biologically active—so a pharmacology question. We've done hepatic impairment studies, but looking at it in a real-world clinical trial is helpful. Third, it will give us a sense of how those patients progress over time to later-stage disease. In our own trial we will see how many of those patients go on to have liver-related or other events. That will be incredibly helpful as we think about powering and sizing an outcome-driven trial, which we are calling NATiV4 for now. Regarding Madrigal's upcoming data, we acknowledge that. Positive data from others would be very helpful for the field. If a surrogate endpoint is shown to correlate with clinical outcomes, that would be an enormous step for the field, similar to what happened in cardio-renal with proteinuria being accepted as a surrogate. We expect that could influence how we think about populations and which populations are most likely to develop liver-related outcomes as we plan outcome trials.

Our next question comes from the line of Michael Yee from UBS.

I have a question myself. First question is on weight gain: can you remind or confirm the views that based on the Phase II and also what you've said in the ongoing Phase III that there is some initial weight gain, but that it plateaus and that you don't really see anything beyond a modest increase in some patients, at least in Phase II, and that it plateaus and that was initially seen in Phase III, and therefore no concerns? The second question is, is there any view that either because of other drugs or because of longer time duration of 18 months versus six months that that could actually come down in some of those patients or at least come back down to baseline—is that possible? And then the third question is around getting the regulators comfortable with that fluid retention effect in some patients and that there would be presumably no initial cardiac imbalance in any of the arms that you see and which you'll be able to talk about no imbalance in any cardiovascular events numerically or any SAEs of that nature when you disclose the data in the fourth quarter?

Mike, you were a little soft so I'm just going to repeat some of it. The questions are: one, does weight gain indeed plateau as seen in Phase II? Two, is there a chance that weight could come down in Phase III either due to concomitant medications or longer treatment? And three, if some weight gain is due to fluid retention, is there any concern about cardiac imbalance or congestive heart failure signals in the trial? Jason, I'll hand that to you.

Mike, good to talk to you. We have previously said and we'll reaffirm that the blinded look at NATiV3 back in September 2024, and the FASST clinical trial in systemic scleroderma, which was a year-long trial with lanifibranor at the same doses, showed that the fluid-retention-related weight gain appears to plateau. We don't have additional public information beyond that at this time, but that is what we've seen in clinical trials so far. On whether weight might come down, it is possible. There are a couple factors: for example, in the LEGEND study, when patients are given SGLT2 inhibitors in parallel with lanifibranor, there was almost no weight gain at all. There are many patients in NATiV3 on SGLT2 inhibitors and other agents that can blunt fluid retention, and we know patients can be started on those agents for management of diabetes or other reasons. So it's entirely possible that if patients are on SGLT2 inhibitors or certain diuretics, the fluid-related weight gain could be blunted or resolved and the final landing place for a patient might be lower than the peak weight gain observed in the trial. Lastly, regarding regulators: fluid retention is a known phenomenon with PPAR gamma agonism. Lanifibranor was designed to be different from other PPAR gammas, and we will see what the data show. Our view is that lanifibranor is a different type of PPAR agonist. That said, fluid retention is an on-target effect and not idiosyncratic. The FDA has shown in other programs that they can manage fluid retention through labeling and risk mitigation. As we've guided publicly over the years, we are not seeing congestive heart failure as a clinical issue in our program, but we will pay careful attention to it and discuss it with FDA.

Our next question comes from the line of Ellie Merle from Barclays.

This is Jasmine on for Elie. As a follow-up to Ritu's question, you talked about the overlap of MASH and type 2 diabetes as a segment where lanifibranor can be particularly attractive. Do you have a specific bar for what competitive data would look like in this population? And specifically, how many type 2 diabetes patients do you think have undiagnosed MASH, and how do you plan to work to increase diagnosis in this population and unlock that segment?

I'll take those two questions. First, the diabetes and MASH overlap is enormous—about 18 million patients in the U.S. with undiagnosed MASH, and at least half or more have diabetes. The market is growing robustly; since about 2024 the market has grown roughly 20%, and we anticipate continued growth. As a company, we'll initially focus on diagnosed patients entering care rather than pushing diagnosis aggressively, because there are sufficient patients being identified now. Regarding the specific bar for competitive data in the diabetic population, the differentiated profile we have is that lanifibranor acts both hepatically and extrahepatically—it works on hepatic fibrosis and on metabolic parameters. If we replicate the 18% fibrosis effect seen in Phase II and deliver meaningful HbA1c lowering (in Phase II we saw just over a 0.5% average reduction), combined with triglyceride lowering and HDL raising, we believe that profile is highly attractive for the diabetic F3 patient.

Our next question comes from the line of Lucy Codrington from Jefferies.

Just one left, please. Regarding the confirmatory trial, do you have an understanding with the FDA in terms of what 'underway' means when it comes to granting accelerated approval? Is it enough just to have started that trial? Does this need to be by the time you file or by the time you get to approval? And then related to that, is starting that trial included in that mid-Q3 cash runway with the third tranche of warrants?

Yes. Starting that trial is included in the cash runway to mid-Q3 that we discussed, assuming full exercise of the tranche 3 warrants. Jason, do you want to talk about what 'underway' means?

Lucy, you have the broad brushstrokes right but some clarification. Accelerated approval is assessed at the time of review. What we're looking for is conditional approval under Subpart H, where you have marketing authorization and then a confirmatory trial that verifies the surrogate and leads to full approval. Broadly, you need to have the confirmatory trial structurally in place and meaningfully underway by the time of filing. What 'meaningfully underway' will mean will be discussed with FDA in pre-NDA meetings and during the mid-cycle review; they typically want to see protocol approval, that the study is progressing, site activations, enrollment curves, etc. Our plan is to have those conversations, have CROs selected, have protocols ready, and potentially have sites open so that at the time of filing the trial will meet FDA's definition of 'meaningfully underway.' At the mid-cycle review FDA will check progress in more detail.

Our next question for today comes from the line of Annabel Samimy from Stifel.

This is Jayed on for Annabel. Two questions: First, around the use of background GLP-1s in the trial—what are your expectations on the potential impact of background GLP-1 use on lanifibranor's effect size? Second, around the AIM-MASH tool (PathAI) that was nearly FDA-qualified as a supportive tool to help with histological assessments—do you have plans to leverage that to control or minimize variability?

Thanks for the question on background GLP-1 use and the PathAI tool. Jason, please respond.

We have previously shared that about 14% of the NATiV3 population, across both cohorts, had background GLP-1 use at the time of randomization—this includes semaglutide and older GLP-1s such as liraglutide or dulaglutide. We do not expect a major impact on treatment response because patients who enter a MASH trial while on GLP-1s still have active disease—GLP-1s are not resolving their MASH in those cases—and the doses in use are typically diabetic doses, which are not anticipated to substantially confound the liver-specific response to lanifibranor. Regarding PathAI (AIM-MASH), it's an interesting tool. It effectively substitutes one human pathologist with a digital reader but you still often need a second human reader and a consensus approach. It's not something we anticipate taking extensive advantage of in NATiV3, but it is something we are thinking closely about for NATiV4 and possibly for exploratory analyses to see what additional signal we can extract from biopsies.

Our next question for today comes from the line of Rami Katkhuda from LifeSci Capital.

Can you remind us of lanifibranor's responses in F2 versus F3 patients in the Phase II study and how those differences may impact expectations for NATiV3 given the higher proportion of F3 patients enrolled?

Rami, the sample sizes in Phase II are too small to draw definitive conclusions from a direct F2 versus F3 split. What we published and presented is more informative: when you strip away the F1s in the NATIVE trial, you get down to about 188 F2 and F3 patients across arms and see that the effect size actually slightly increases. In our view the drug works equally well in earlier and more advanced fibrosis within those ranges. In NATiV3 we stratified by fibrosis stage and diabetes, so we will be able to cut the data in several ways. We like where we landed with NATiV3's composition and our expectation of efficacy in both F2 and F3 patients.

Our next question for today comes from the line of Srikripa Devarakonda from Truist Securities.

Two questions: First, looking ahead in terms of MASH guidelines, would you expect an update this year and how are you thinking about getting lanifibranor into the guidelines? Second, in terms of cash, what needs to happen for you to have access to that third tranche? Is it based solely on Phase III success? And are you looking at any other non-dilutive sources of funding such as partnerships?

On the guidelines, we need data before we can engage in conversations about guideline inclusion for lanifibranor. Regarding cash and the third tranche: the tranche 3 exercise is tied to a positive endpoint—if we hit a positive endpoint in our trial and the stock is above the exercise level, those warrants or shares can become exercisable and provide additional cash. Mechanically, the conversion and exercise windows apply as stated in our financing agreements. We are always looking at ways to increase cash runway. Right now we are well funded and our plan is to commercialize lanifibranor ourselves; therefore, we are not dependent on a partnership for this asset. However, we continue to evaluate capital alternatives, including equity markets and other sources, and we are open to opportunistic non-dilutive funding as appropriate.

Our next question comes from the line of Sushila Hernandez from Van Lanschot Kempen.

Could you elaborate on your regulatory and commercial infrastructure? What steps are you taking to act with speed once the data is here, also considering your cash runway?

Good question. We are careful stewards of capital pre-data. The regulatory team is fully staffed, and we have also expanded the quality team because that is necessary to make a robust filing with FDA. From a commercial standpoint, we are focused on strategic commercial execution led by Nazira Amra. We're building capabilities in market access, market research and medical affairs to be prepared for launch activities, but we will not staff up aggressively in commercial until we have positive data. Our approach is to be lean and targeted, investing in the right capabilities that will allow us to move quickly when and if we have favorable results.

This concludes today's question-and-answer session. I will now hand the call back to Andrew Obenshain, CEO of Inventiva, for closing remarks.

Thank you so much. Thank you, everyone, for joining the call this morning. We certainly have an exciting remainder of the year coming up for Inventiva, and we look forward to engaging with you all as we go forward. Thank you.

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