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Inventiva (IVA) Q2 2026 Earnings Call Transcript

Motley Fool
Image source: The Motley Fool. Sept. 28, 2026 - Head of Investor Relations-David Nikodem - Chief Executive Officer-Andrew Obenshain - Chief Medical Officer and President of R&D-Dr. Jason Campagna - Chief Financial Officer-Axel-Sven Malkomes - Chief Operating Officer-Chris Benecchi Operator: Day, and thank you for standing by. Welcome to Inventiva's first half of 2026 financial results conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. As a reminder, today's conference call is being recorded. I would now like to hand the call over to David Nikodem, Head of Investor Relations for Inventiva. Please go ahead. David Nikodem: Thank you. Good morning, good afternoon. Thank you for joining Inventiva's first half 2026 financial results and business update. This morning, we issued our press release reporting our full financial results for the first half of 2026. A replay of this webcast will be available in the investor section of our website following the call. Before we begin, a quick reminder that the statements we make today, including during the Q&A, may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements reflect our views only as of today and should not be relied upon at any later date. Please refer to slide two and to our filings with the SEC and the AMF for a discussion of the associated risks. Joining me today are Andrew Obenshain, our Chief Executive Officer, Dr. Jason Campagna, our Chief Medical Officer and President of R&D, and Axel-Sven Malkomes, our Chief Financial Officer. Chris Benecchi, our recently appointed Chief Operating Officer, will be joining us for the Q&A portion of the call. With that, I'll turn the call over to Andrew. Andrew Obenshain: Thank you, David, and welcome everyone. Today, I'll start by providing an update on the company and our priorities. Jason will overview our lanifibranor development program. Axel will walk through our first half of 2026 financial highlights, and then we will open the call for Q&A. The first half of 2026 has been a defining period for Inventiva. We have stayed focused on our near-term objectives, advancing lanifibranor toward the phase III top-line results readout in MASH expected in Q4 2026, preparing for regulatory filing while build…Read full document

Image source: The Motley Fool. Sept. 28, 2026 - Head of Investor Relations-David Nikodem - Chief Executive Officer-Andrew Obenshain - Chief Medical Officer and President of R&D-Dr. Jason Campagna - Chief Financial Officer-Axel-Sven Malkomes - Chief Operating Officer-Chris Benecchi Operator: Day, and thank you for standing by. Welcome to Inventiva's first half of 2026 financial results conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. As a reminder, today's conference call is being recorded. I would now like to hand the call over to David Nikodem, Head of Investor Relations for Inventiva. Please go ahead. David Nikodem: Thank you. Good morning, good afternoon. Thank you for joining Inventiva's first half 2026 financial results and business update. This morning, we issued our press release reporting our full financial results for the first half of 2026. A replay of this webcast will be available in the investor section of our website following the call. Before we begin, a quick reminder that the statements we make today, including during the Q&A, may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements reflect our views only as of today and should not be relied upon at any later date. Please refer to slide two and to our filings with the SEC and the AMF for a discussion of the associated risks. Joining me today are Andrew Obenshain, our Chief Executive Officer, Dr. Jason Campagna, our Chief Medical Officer and President of R&D, and Axel-Sven Malkomes, our Chief Financial Officer. Chris Benecchi, our recently appointed Chief Operating Officer, will be joining us for the Q&A portion of the call. With that, I'll turn the call over to Andrew. Andrew Obenshain: Thank you, David, and welcome everyone. Today, I'll start by providing an update on the company and our priorities. Jason will overview our lanifibranor development program. Axel will walk through our first half of 2026 financial highlights, and then we will open the call for Q&A. The first half of 2026 has been a defining period for Inventiva. We have stayed focused on our near-term objectives, advancing lanifibranor toward the phase III top-line results readout in MASH expected in Q4 2026, preparing for regulatory filing while building the organization to support a potential commercial launch. Let me start with why we believe in the potential of lanifibranor and why a potential new therapy for MASH is so important. It comes down to three key elements, differentiation, late-stage validation, and market opportunity. Let's begin with differentiation. MASH is driven by both intrahepatic and extrahepatic processes, and lanifibranor is designed to address both through a single once-daily oral therapy. In our NATIVE phase II-B study, lanifibranor showed improvement across all key histological endpoints. Next is validation. We designed the NATiV3 phase III trial to build on the foundation established in our positive phase II-B study. We look forward to reporting top-line data in the fourth quarter of this year. Finally, market opportunity. The market is being built in front of us. If lanifibranor is approved, we will enter an established therapeutic area with a market potential expected to exceed $15 billion by 2035. However, significant unmet need remains, and this represents a meaningful opportunity for Inventiva to bring a potentially differentiated treatment option with lanifibranor to people diagnosed with MASH, if approved. Let me take each in turn and then lay out our priorities for the year ahead. Let's start with differentiation, and it begins with understanding the biology of the disease. MASH is not simply a liver problem. It is the hepatic expression of a broader systemic metabolic dysfunction. As slide six shows, the disease is driven by multiple interconnected pathways, both outside and inside the liver. These include insulin resistance, adipose dysfunction, and dyslipidemia on the extrahepatic side, and steatosis, inflammation, and fibrosis within the liver itself. That has clear implications for treatment. If the disease is driven by several processes at once, there is an opportunity for next-generation treatment to target more than just one driver. That is the unmet need we believe lanifibranor could address if approved. Our aim is not only to target the liver, it is to modulate pathways across both the metabolic and hepatic components of the disease and bring a differentiated treatment option to patients with MASH. The differentiated mechanism of lanifibranor modulating both pathways is reflected in compelling clinical data. In our phase II-B study, after six months, lanifibranor delivered an 18% placebo-adjusted improvement in fibrosis, 26% on MASH resolution, and 24% on the composite endpoint. Those results were the foundation for NATiV3, where we are now testing the same approach in a larger control phase III population of patients with F2 and F3. That is what makes NATiV3 so impactful. It was designed to confirm at pivotal scale the biology and activity we observed in our phase II-B study, and we are pursuing this in a market with substantial and growing unmet need. As slide eight shows, there are an estimated 18 million Americans living with MASH, yet only 10% are diagnosed. That is changing fast. As the treatment landscape has matured, diagnosis has increased, up roughly 25% versus 2024, and that is translating into a larger population being actively identified and managed. Today, approximately 374,000 patients with F2 or F3 disease are already in treatment or under the care of a physician. The picture is clear. A large prevalent patient population expanding rapidly as awareness and testing improve, and a compelling opportunity for lanifibranor if approved. Turning to slide nine. To see where lanifibranor may fit in the treatment paradigm, it helps to think about MASH in terms of two factors that are top of mind for physicians, the severity of fibrosis and the cardiometabolic factors that can influence the risk of disease progression. Put fibrosis on one axis and cardiometabolic risk on the other, and four clinically distinct populations come into view. Start with the lower right quadrant. We have patients with F3 MASH and cardiometabolic risk, such as type 2 diabetes. This is a population with high unmet medical need, where the mechanism of action of lanifibranor could be compelling in that it targets both the liver and the metabolic drivers simultaneously. In our phase II-B trial, lanifibranor demonstrated an 18% placebo-adjusted improvement in fibrosis at just six months. Similarly, in the lower left, although these patients have earlier stage F2 fibrosis, their cardiometabolic risk factors can put them at risk for more rapid disease progression. For these patients, physicians may also want to act urgently, and lanifibranor could potentially offer an opportunity to intervene earlier in the course of the disease if approved. Moving to the top right quadrant. By extension, lanifibranor could be well-positioned in patients with F3 fibrosis without significant cardiometabolic risk. Here, the fibrosis itself is the primary concern, and lanifibranor may have the potential to address the underlying liver disease before it progresses. Taken together, these three quadrants represent a large population with significant unmet need, and if approved, we believe lanifibranor has the potential to play an important role in addressing the needs of these patients. With that overview of why we believe in the potential of lanifibranor, let me lay out three key priorities we are focused on to unlock new opportunities for patients with MASH. First, the NATiV3 trial. We remain on track to report top-line data in the fourth quarter of 2026. Earlier this month, the last patient completed their final 72-week visit. The main cohort enrolled 1,009 participants, all with biopsy-confirmed non-cirrhotic MASH and F2 or F3 fibrosis. Second, regulatory readiness. We are advancing our preparations now to support a potential NDA submission with the FDA in the first half of 2027, positioning us to move quickly into regulatory interactions if the top-line data read out as positive. Third, commercial readiness. We are building a commercial organization with the depth and breadth of experience with the best in disease products to be ready for the potential launch in 2028. We believe we are moving forward with lanifibranor from a position of strength and with a potential for a differentiated profile, a late-stage validation opportunity with NATiV3, and a significant market opportunity if approved. I am truly energized by the potential to make a real difference for millions of people living with this serious disease. With that, let me hand it over to Jason to take you through the science behind lanifibranor and our clinical program. Jason? Jason Campagna: Thank you, Andrew, and greetings, everyone. I will spend a few minutes on four aspects of our lanifibranor development program in MASH. One, how lanifibranor is designed to address the spectrum of disease. Two, what we have observed in the positive NATIVE phase II-B clinical trial. Third, how our NATiV3 phase III trial is built to confirm that phase II study. Lastly, where we are thinking of taking the program next. Let me start with the molecule. As Slide 11 shows, lanifibranor is a potential novel new chemical entity, structurally and mechanistically distinct from both fibrates and thiazolidinediones, and recognized by the FDA with both breakthrough therapy and Fast Track designations. It was informed by decades of research on PPAR biology and the development learnings of prior compounds, and it rests on one critical concept, balance. Lanifibranor engages all three PPAR isoforms, alpha, delta, and gamma, in a low-potency balanced manner such that no single receptor biology dominates. It was also engineered to have only partial agonism of the PPAR gamma receptor. The combination of this balanced low-potency pharmacology and partial PPAR gamma agonism are the keys to our differentiation. It is what lets lanifibranor modulate in harmony the metabolic, inflammatory, and anti-fibrotic pathways of MASH combined rather than forcing one mechanism or receptor at the expense of the others. The two charts on the right illustrate this designed pharmacology. On the first panel, we see the balanced activation profile and the approximately 80% gamma activation with lanifibranor. While on the far right, the cofactor recruitment fingerprint that sets lanifibranor apart from full TZD gamma agonists. The result is a once-daily oral therapy intended to deliver a physiologic balance between achieving pan-PPAR activation and avoiding any one receptor dominance. Moving now to our phase II-B NATIVE clinical trial data. Andrew shared our overall histology efficacy data, but that included patients with lower risk earlier F1 disease. When we exclude these patients with earlier stage disease, we continue to see robust effects across all three histologic endpoints, showing that the drug worked equally well in both early and later stage disease. These results were achieved after only six months of treatment. Looking more closely at the data for the composite endpoint, you can see that treated patients were roughly eight times more likely than placebo patients to achieve dual histologic improvement in the type 2 diabetes subgroup. This tells us that spontaneous regression of the disease was uncommon and that the treatment effect of lanifibranor was strong. Together with the early and late-stage data, these results underscore the potential of lanifibranor to perform across the disease spectrum, including in patients with the most urgent disease. Let me now turn to safety and tolerability. On slide 13, we show the most frequently reported adverse events by investigators in our NATIVE phase II-B clinical trial. Lanifibranor was generally well-tolerated across the totality of our phase II program, but the adverse event profile in NATIVE IIb tracked closely with the underlying scientific design of lanifibranor. Consistent with our preclinical toxicology data, we saw minimal classic alpha or delta toxicities. On gamma-related effects, weight gain, edema, and hemoglobin decline, these were present but attenuated relative to the full TZD class gamma agonists. The weight gain we observed in patients treated with lanifibranor is biphasic. Early on, the partial PPAR gamma activation acts on a sodium channel in the kidney, resulting in sodium and water retention. While in a later phase, that same partial PPAR gamma activation drives improved insulin sensitization and adipose remodeling, reflected in the rise in adiponectin, which is itself tied to histologic efficacy. Both phases are consistent with the known pharmacology of PPAR gamma engagement. Based on our LEGEND study, these gamma-related effects were mitigated by adding an SGLT2 inhibitor, empagliflozin, while also preserving the metabolic benefit of lanifibranor. This brings me to NATiV3. This is a phase III global registrational trial, and it was deliberately designed to build on our phase II-B. The same two doses, a similar patient population, and a primary composite endpoint of MASH resolution and at least one-stage fibrosis improvement in the same patient. Secondary endpoints include MASH resolution and fibrosis improvement of one stage or more. The trial enrolled approximately 1,400 patients across two cohorts, a placebo-controlled randomized portion consisting of 1,009 patients with biopsy-confirmed F2 or F3 MASH, and an exploratory cohort of 410 patients with predominantly F1 or F4 disease. Both cohorts were treated for 72 weeks. All patients who completed the trial are eligible for an active treatment extension to support a longer-term view of the safety and tolerability of lanifibranor. The main cohort will serve as the basis for global marketing registration, and the primary endpoint is powered at 90% on deliberately conservative assumptions with a higher placebo response and a lower treatment effect than we observed in the phase II-B NATIVE trial. It is stratified by fibrosis stage and diabetes status. This main cohort also reflects the real world. The NATiV3 population is a contemporary MASH population with higher diabetes prevalence, more advanced fibrosis, and more use of GLP-1s and SGLT2 inhibitors compared to our phase II-B trial. As Andrew noted, it has been fully recruited, and the last patient visit for the week 72 portion of the trial was completed earlier this month. As Andrew shared, we are excited for top-line data in the fourth quarter of this year. Subject to positive phase III results, we intend to file for accelerated approval with the FDA and conditional approval with the EMA. We will also be initiating a confirmatory clinical outcomes trial designed to evaluate the effects of lanifibranor in patients with more advanced disease. That's worth pausing on because everything I've described targets the core pathophysiology of MASH. That same pathophysiology also underlies compensated advanced chronic liver disease, or cACLD, due to MASH. These are patients who have progressed to advanced fibrosis or early histologic cirrhosis, yet they remain clinically compensated but have evidence of clinically significant portal hypertension, the primary driver of adverse liver-related outcomes. This subgroup of patients has no approved disease-modifying therapy. It is a significant area of high unmet need in the disease. We believe that lanifibranor is mechanistically compelling in cACLD because the same PPAR isoforms that drive the histologic and metabolic effect in the non-cirrhotic MASH population also act on the vascular biology that underpins portal hypertension in this more advanced group. In cACLD, portal pressure matters because as the disease advances, portal hypertension and not fibrosis alone becomes a key driver of these hard clinical outcomes, including bleeding, ascites, and liver transplant. We recently published an analysis of our phase II-B NATIVE trial showing a correlation in patient biopsies with vascular remodeling we've observed preclinically. These are exploratory analysis, but they add to our conviction to pursue further advanced disease states in MASH. With that, I'll hand it over to Axel. Andrew Obenshain: I will pick up for Axel here. Axel-Sven Malkomes: I'm sorry, I lost my text. Please go ahead. Andrew Obenshain: Yes. This morning we issued our press release reporting our full financial results for the first half of 2026. Axel will focus on the key financial highlights and our financial position as we approach the NATiV3 top line readout. Axel, are you ready to take over? Axel-Sven Malkomes: Not yet. Andrew Obenshain: Okay. As of June 30, 2026, we had EUR 233.9 million of combined cash equivalents, and short-term deposits. We significantly strengthened our financial position through the comprehensive capital structure optimization that we announced in June. Under that, we bought back approximately 60% of the EIB warrants with anti-dilution protection for EUR 50 million, and repaid our EIB loans for EUR 63 million. In addition, the remaining EIB warrants with anti-dilution protection were canceled. Inventiva issued new EIB warrants in exchange, as described in the July 9, 2026, press release. Axel-Sven Malkomes: I am ready to take over. Andrew Obenshain: Please go ahead. Axel-Sven Malkomes: As part of this optimization, we secured new debt financing of up to EUR 130 million in three committed tranches, subject to conditions with an initial drawdown of two tranches of EUR 75 million gross, plus an additional uncommitted tranche of up to EUR 20 million, as described in our press release of June 2, issued earlier this year. We also completed an underwritten public offering of our American depositary shares, generating gross proceeds of EUR 103 million. Together, these actions strengthened our balance sheet, extended the maturity of our debt, and simplified our capital structure. Our current financing assumptions, existing resources, and completed financing transactions provide cash runway until the end of the second quarter of 2027, seeing us through key milestones, the phase III top-line data readout, and potential NDA filing. Assuming full exercise of Tranche 3 warrants on the back of a positive top-line result, as well as successful completion of Tranche C of the debt financing transaction, our cash runway would extend to the start of the first quarter of 2028. R&D expenses were EUR 46.2 million in the first half of 2026, brought in line with the prior year and reflecting continued clinical development of lanifibranor MASH. Marketing and business development expenses increased to EUR 2.6 million, and G&A expenses increased to EUR 22.2 million. Overall, we entered the second half of 2026 with a strengthened balance sheet and financial visibility for the company. With that, I'll turn the floor back to Andrew for his closing remarks. Andrew Obenshain: Thank you, Axel. This is truly an exciting time for Inventiva. Our differentiated mechanism of action, the results we saw in the NATIVE phase II-B trial, and the robust design of our NATiV3 phase III trial provide a strong foundation as we approach the milestones ahead. The next major milestone is our NATiV3 top-line results readout, expected in the fourth quarter of this year. If positive, it could support the U.S. regulatory filing in the first half of 2027 and a potential EU filing to follow. If approved, we're prepared for a potential U.S. commercial launch in 2028, with the goal of bringing a new treatment option to patients with significant unmet need. We also expect to initiate an outcomes trial, which could support a potential opportunity for lanifibranor to expand into more advanced disease populations. Stepping back, what does this all mean for lanifibranor? Let me bring it back to where I started. Why lanifibranor and why now? Lanifibranor is designed to target both the metabolic and hepatic drivers of MASH in one oral medicine. Our pivotal top-line results readout is imminent in Q4 this year. The market is established and significant unmet need remains. We have established the foundation to build a launch-ready organization and prepare for the next stage of development. We are moving forward from a position of strength with the discipline and the urgency that people living with MASH deserve, and I'm genuinely excited about what lies ahead. With that, let me hand it back to the operator to begin Q&A. Operator? Operator: Thank you. We will now open lines for questions. To ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. You are kindly asked to limit yourself to one question and one follow-up. If you wish to ask any further questions, you may reenter the queue. We'll now move to our first question. Our first question comes from the line of Yasmeen Rahimi from Piper Sandler. Please go ahead. Your line is open. Yasmeen Rahimi: Good morning, team. Congrats on all the updates and thank you so much for walking us through some of the key questions. Maybe, we've been lately getting questions from investors how we should be thinking about the two doses in the NATiV3 study, and whether it would even make sense commercially if both showed a clinically meaningful difference to move forward. Would love to get your thoughts. Maybe one other one that sometimes comes up is that the higher dose had a phenomenal histological benefit, but then when we compare the NITs, the two doses look more the same. Would love if you could maybe comment on both. That would be very helpful as it's on top of a few of the investors that have been asking us that. Thank you. Andrew Obenshain: Thank you, Yasmeen, and good morning. So two questions in there. First one, I think more of a commercial question, which I'll take, then I'll pass it on for the correlation with histology and dose to Jason in a second. First, if both doses are statistically significant positive, I think it would make sense to bring both forward in the market. It's going to depend on the data. So we'll clearly look at what the efficacy is with each dose and the tolerability with each dose. There could be scenarios in which the difference between the two makes sense to bring both to the market, potentially one for two patients or one you could think of as earlier stage patients that are less urgent and so therefore would be OK with a dose response or lower efficacy and more tolerable. If another one, if you have a tolerability difference between low and high, then a higher dose with still tolerable but a slightly different profile, we could see bringing both forward, but that really remains to see in the data. It's a little bit too early to speculate until we get the actual data to see it. Jason, let me hand the second question over to you, the correlation with NITs. Jason Campagna: Sure. Happy to. Yasmeen, good morning. So in the NATIVE phase II trial, generally speaking, the histology endpoints tracked well with most, but not all of the clinical biomarker endpoints. Obviously, ALT/AST reduction was evidenced. This reflects hepatocellular injury. Moving into fibrosis, you can think of the data that we had as looking at both new scar being laid down and active scar resorption. Pro-C3 is the best example of new scar being laid down. It's a fragment of procollagen peptide, and the Pro-C3 marker actually tracked quite nicely with the 1,200 milligram histology efficacy endpoint. Similarly, when we look at ELF, the hyaluronic acid was a little noisy at baseline, but the two other components actually tracked very nicely in a dose-dependent manner, representing that we were, in this case, resorbing some existing scar. Lastly, on the TE, it's very difficult to compare trials, Yasmeen, as you know, across different sponsors. When you look at the data ranging from six months to 18 months, the range in TE liver stiffness measurement ranges from about a 1% placebo-adjusted change all the way up to like a high, sorry, 1 kPa up to a high of 3 kPa. So that's somewhere around 10%-30%. Lanifibranor came in at the lower end of that range, and it's our belief that's, one, it's just early in the disease to really have movement on liver stiffness. It's a composite view of what's going on in the liver. More importantly, we know that lanifibranor has some confounding due to that fluid retention. This is a known concern with liver stiffness in general, listed in the Echosens manuals about being cautious about getting liver stiffness data after a meal or in the presence of fluid loading. At six months, the dynamic fluid flux that's still happening due to the PPAR, we believe is likely impacting some of that. So we landed at about a 10% reduction in liver stiffness, about a 1 kPa placebo-adjusted number. We're confident that with a longer treatment duration, the underlying fibrosis improvements will, in the end, dominate that signal by 18 months. Yasmeen Rahimi: Thank you so much. Operator: Thank you. We'll now move on to our next question. Our next question comes from the line of Seamus Fernandez from Guggenheim Securities. Please go ahead. Your line is open. Seamus Fernandez: Oh, great. Thanks for the question. Just wanted to get a sense of the information that you guys have on a blinded basis as it relates to weight gain throughout the NATiV3 study. If you might be able to share what's with your expectations for potential weight gain. What we've heard from thought leaders is 18% would be a highly differentiated threshold for fibrosis change, very consistent with what you've commented on. But I think there is the trade-off of potential weight gain and edema that some physicians have commented on and may have a higher bar for fibrosis difference over time. Just interested to know what information you guys have on the weight gain and edema, how patients actually feel on drug that has any meaningful impact on the durability and sustainability of the use of lanifibranor in the NATiV3 study. Thanks so much. Andrew Obenshain: Yeah. A couple elements to that question. Let me hand it to Jason to talk about the first part, which is what have we shown from a blinded basis from the phase III trial on weight gain, and then I can take it from there. Jason, go ahead. Jason Campagna: Yeah, sure. Seamus, good morning. We previously disclosed back when the structured financing back in 2024, some data on our phase II clinical trial in the scleroderma population. This is a non-metabolic population treated for a year with the same doses of lanifibranor that are in the MASH program. In that trial, we showed that the weight gain was similar up to six months to what we saw in the NATIVE phase II-B trial and thereafter, where NATIVE II-B stopped at six months. Thereafter, the weight gain appeared to plateau right around the week 24 to week 30 and remained stable there out through to the end of the study at week 48. We're not guiding any additional data or input on NATiV3 in any manner. I think, Andrew, to turn this over to you, I think that the data that we have in NATIVE is actually really representative of some of the questions Seamus asked, and I'll answer that and turn it back to you. Seamus, you're really getting at what's the potential impact of things like weight gain, edema? I think that's the right question. When you look in the NATIVE trial, about half of all patients in that trial had no weight gain defined as anything beyond plus or minus 5%. Among the patients, therefore, that did have weight gain, when you look at the adverse event reporting in that trial, only about 10% of the reports related to weight gain. That is consistent with the idea that weight gain is not seen by patients or providers as a safety or tolerability concern. And in that trial, we had about 30 approximately dropouts, and weight gain was not a primary driver of the tolerability concern there and discontinuing treatment. So our view is that at least from the completed NATIVE clinical trial, that weight gain is not an impediment to patients staying on treatment. And the perception of weight gain by both providers and patients is not one around safety and tolerability. Andrew, over to you. Andrew Obenshain: Well, I do not think I could say it better than you, Jason. That was perfect. I think we can move on to the next question. Operator: Thank you. And our next question comes from the line of Ritu Baral from TD Cowen. Please go ahead. Your line is open. Ritu Baral: Good morning, guys. Thanks for taking the question. I guess I have the same question, in terms of edema, which is, I guess, related but separate in the sense that, I think KOLs see that less as a true safety issue, but potentially a tolerability issue. Is this something you guys have interrogated in your market research insofar as what level and severity that the edema becomes inconvenient or unacceptable to MASH patients and that risk-benefit around sort of extremitous edema, versus any potential issue of fluid load. Thanks. Andrew Obenshain: I will start out, then I will hand it to Jason as well. A very similar answer to before. The edema is mechanistically understood, is consistent with known PPAR gamma pharmacology. That makes physicians, especially those who use pioglitazone in the market, very comfortable with managing those types of effects. We are looking for in the larger NATiV3 data set to provide a more comprehensive safety characterization overall. But in general, the physicians know that they can mitigate the MFX linked to fluid retention, weight, edema, hemoglobin, by addition of an SGLT2, if they want to manage it. We do view this as a profile that is very commercially attractive. Jason, do you have anything to add to that? Jason Campagna: I do just briefly. Edema, as Andrew mentioned, is a known on-target consequence of PPAR gamma. I want to make a distinction between the prevalence of edema in the NATIVE II trial, the unadjusted prevalence, meaning independent of assessment, ranged between 7% and 10% on the two doses, and the drug-related edema was about 2%. Contrast that with what we know from pioglitazone in a similar MASH population, you are somewhere in the mid 20s, 20%-25% edema range. So that is a prevalence. In terms of the severity, which I think, Ritu, was where your question was headed, is that generally these events are considered mild to moderate. Going back to the NATIVE II-B clinical trial, these were not primary drivers of patients discontinuing treatment. Most of the edema in the experience of our clinical program is so-called peripheral edema. It happens in the lower extremities, where present occasionally periorbital around the eyes, but generally this is a mild to moderate view. Most importantly, the difference between a pure PPAR agonist like pioglitazone, for example, is fairly large, which is consistent with our view that this is a more blunted or more attenuated gamma effect that you would see with a full TZD class agonist. Ritu Baral: Would you expect it to be transient? Jason Campagna: I'm sorry, Ritu, do I expect it to be? Ritu Baral: Sorry. Would you expect the edema to be transient, and if so, would it be during the full 18 months, and would that be communicated? Jason Campagna: I think we're not giving any guidance on what we expect over time. I think that 18-month trials are long. The fluid is due to salt and water. To the extent that patients may or may not have already on a pre-existing agent like SGLT2s or thiazide diuretics, that may impact it. Also mild changes in diet around salt intake and/or fluid can impact that. I think our view is that the pharmacology is well understood here and the overall mechanism, and that going back to your core point, we don't view it as a tolerability concern or gating in any way to patients staying on it. Maybe I'll make the simple point. Pioglitazone is a generic therapeutic at this point. It's still used about 4 million scripts a year in the U.S., and that's with very minimal histologic efficacy on anything outside of MASH. I think the question you're really asking is, if we added an 18% one-stage improvement of fibrosis or more to that profile, would people use more or less of it? I would argue they would use more. I think even better evidence that it's much less of a tolerability concern in the market than we see it in the clinical program. Ritu Baral: Understood. Thank you. Operator: Thank you. We will now move on to our next question. The next question comes from Thomas Smith from Leerink Partners. Please go ahead. Your line is open. Thomas Smith: Hey guys, good morning. Congrats on the progress and thanks for taking our questions. First, from a compliance perspective, can you just remind us, is there any protocol or counseling that is built into the study for patients that are experiencing weight gain or edema to help them manage this and stay on the study? Also wondering if you have any visibility into the proportion of patients who have rolled over into the active treatment extension portion of NATiV3 on a blinded basis. Then just a bit on your market research. You highlighted the 374,000 F2, F3 patients diagnosed under the care of a specialist. That is a bit lower than the 460,000 we have heard from a competitor. I was just wondering if you could talk a little bit about the differences there and how you are thinking about patient targeting relative to Rezdiffra. Thanks so much. Andrew Obenshain: Yeah. Thanks for the question, Thomas. Let me handle the first two, then hand it over to Jason. On the active treatment role, we are not commenting on that yet. We have not publicly disclosed that information. On the patient population, yes, there are some range of estimates out there. The 374,000 is certainly on the low end of that. We have not updated that number, but certainly, I think the real message here is that it is a very sizable population, and growing rapidly. So that number will continue to evolve. Jason, over to you on how weight gain was managed in the trial. Jason Campagna: Yeah. Thomas, good morning. Good question. There's no formal management algorithm or treatment algorithm in the NATiV3 protocol. However, investigators are educated as to the mechanism. Generally, once they know that the protocol does allow them, if they choose to manage the weight gain, the fluid retention with the use of either diuretics or SGLT2s. Keep in mind, patients in this population are already on, many of them are already on diuretics for hypertension control, et cetera. So the providers have the opportunity to utilize therapeutics that may already be in use to manage, but there's no formal management algorithm that they're required to follow. Thomas Smith: Understood. Super helpful. Thanks, guys. Looking forward to the data. Andrew Obenshain: Yep. Operator: Thank you. We'll now move on to our next question. Our next question comes from the line of Michael Yee from UBS. Please go ahead. Your line is open. Kyle Yang: Hey, guys. Good morning. This is Kyle Yang for Michael Yee. Just two for us. The first one is on the F2, F3 mix. We did notice that NATiV3 enrolled a meaningfully higher proportion of F3 patients relative to NATIVE phase II-B. How do you expect that to impact both efficacy on the drug arms and placebo arm? The second question is on GLP-1 drop-ins. You previously disclosed roughly 10% GLP-1 dropping rates during this study. How do you think that could potentially impact the outcomes on both the drug arms and placebo? Thank you. Andrew Obenshain: Yeah, absolutely. Let me just set the stage. I am going to hand it over to Jason to answer that. On the F2, F3, the mix was indeed different in the phase III. We enrolled more patients in the U.S. in the phase III than we did in the phase II. The patient population looks a little bit different in the U.S. There is more diabetes, and diabetes and F3 track together. Therefore, we had slightly more diabetic patients and slightly more F3 patients in the study. We have looked at our phase II when next time we removed the F1 patients from our phase II. We saw a slightly better response rate in the F2 and F3 combined than we saw in when it was combined with the F1, which gives us confidence that we are going into at least a drop in the F1s from the study will not impact the patient population. I will have Jason comment in a second just on the split in F2 and F3. On the 10% drop-ins, it is actually 9% drop-ins on GLP-1s. We do not anticipate that to impact the trial as when they dropped in, they drop in on the non-MASH dose. They have dropped in on a lower dose. Jason, over to you. Jason Campagna: Yeah. Thank you, Andrew. Just adding on to Andrew's response there around F2, F3. I agree. We do not have any expectation that the larger prevalence of F3 patients should impact the primary efficacy readout. I think three additional reasons. One, there is nothing in the biology of F2 or F3 disease that is different from each other. It is just a more advanced version of the exact same biology. I think second, that lanifibranor has direct anti-fibrotic actions to hepatic stellate cells in the liver. That direct action, meaning it does not depend on extra hepatic elements in order to achieve fibrosis. Things like weight loss or glucose metabolism, they are additive, but they are not required for fibrosis improvement. Third, the time duration of the trial actually will help to this extent. I think clearly, if the biology takes more time in an F3 patient to resolve, which is not unreasonable, a longer clinical trial should give us visibility into that. So we are pretty comfortable with that 18-month duration for NATiV3. Lastly, the FGF21 analogues like efruxifermin have shown similar efficacy in F2, F3, and I highlight them because those drugs, although very different mechanism of action, they actually have similar impact on both intra and extrahepatic drivers to some degree. So although not a complete overlap with pan-PPAR agonists, there are some elements that do, and I think that is support for the fact that by getting both direct action in the liver and modulating some extrahepatic drivers of disease, this difference between F2, F3 is unlikely to be a concern. Operator: Thank you. We will now move on to our next question. Our next question comes from the line of Annabel Samimy from Stifel. Please go ahead. Your line is open. Annabel Samimy: Hi. Thanks for taking my questions. I guess one question, with the patients on the GLP-1s and SGLT2s, are there any pre-specified analyses of these patients? Are any of those subgroups powered to show any kind of difference or statistical analysis on how those patients perform with that background of GLP-1s or SGLT2s? I guess you touched on this before, but how you might account for any changes in the background mid-trial. Then how might that inform physicians on how to incorporate these drugs? Is there any specific protocol that you would be recommending going forward? Andrew Obenshain: Thank you, Annabel, for the question. On the second, it is a little bit too early to comment on any sort of guidance to physicians by Inventiva post data. Let me go for the first part. Jason, let me hand it to you. Jason Campagna: Sure. There are several questions there. Let us go through it. Yes, there are sensitivity analyses that we have pre-specified in the SAP to allow us to look at the impact, if any. Again, as Andrew said, we do not expect any, but the analyses are there on the use of these non-MASH dose of GLP-1s and the use of SGLT2s. I think second, no, none of those groups are in any way powered. We are powered on our primary endpoint. That is the intent of the trial. As I have mentioned before, the power in detail there. Third, I think the important point I think we want to convey here is that there is nothing unusual or different that we are doing in this phase III trial than any other sponsor in any other phase III trial would do to account for therapeutic drop-ins. Even in the case of MASH, if you go back to Intercept's REGENERATE trial, the questions in that era were, what about statins and what about other antidiabetic drugs? Liraglutide had shown in the LEAN study that there was evidence that it could work. Pioglitazone. The answers there were the same answers here, that for any drop-in that may theoretically impact your concern for efficacy, sensitivity analyses are built in to give us and FDA confidence that the treatment effect we see is due to lanifibranor and not due to any other agent that may be dropped in during the course of the trial. Annabel Samimy: Okay, great. That's helpful. If I can ask one more quick follow-up for Axel. How are you guys preparing for the launch, and have you laid out what kind of funds you might need for the launch? Andrew Obenshain: Axel, go ahead. Axel-Sven Malkomes: Yeah, sure. Let's take a step back. We have done our capital transaction, as you all know, in June of this year, which gives us a solid funding until the end of Q2 2027. If we would have positive data, and we could, in addition, add the financing out of the structured financing Tranche 3 as well as the Tranche C out of the refinancing, we would extend that cash runway until the start of the beginning of Q1 2028. So with that, we basically can fund the following catalysts. Point one, the data read out now in Q4. Point two, we are funded until the NDA filing. On top of that, we do not guide on any future raises. But with what we currently have, we believe we have strengthened the balance sheet, simplified the cap structure, prolonged the debt maturity. And with that, we are basically solidly financed prior to the data release. Annabel Samimy: Okay. Thank you. Operator: Thank you. We will now move on to our next question. Our next question comes from the line of Prakhar Agrawal from Cantor. Please go ahead. Your line is open. Prakhar Agrawal: Hi. Thank you so much for taking my questions, and congratulations on all the progress. Maybe I had a couple of questions. Firstly, can you talk about the biopsy completion rate in the trial and whether that is tracking in line with some of the recent phase III MASH trials? A couple on weight gain. Maybe mechanistically, why does the weight gain plateau for lanifibranor and not for PPAR gamma pioglitazone? If I remember correctly, I think the company had previously shared interim weight gain data from the ongoing phase III a couple of years back. Realize it was interim, but was a decent enough sample size. So why should not we use that as a reference for understanding what the weight gain profile could look like in the final analysis in the phase III? Thank you so much for taking my questions. Andrew Obenshain: Yeah. Thank you for the questions, Prakhar. We will address the, you asked about a biopsy completion rate. What we have guided on publicly is a dropout rate for the trial overall. We powered the trial such that we could tolerate up to a 30% dropout rate in the trial. We have guided in, we believe it was April and May 2005, that dropout rate was below 30%, and we confirmed that dropout rate is comfortably below 30% at that time. We are not giving more guidance beyond that. Regarding the weight gain, you had a question about the plateau and the difference pioglitazone. We are hoping Jason picked it up to be able to talk about both those points. Jason, go ahead. Jason Campagna: Yeah, we agree. Prakhar, we will come back to the reference. We missed that. On the question of plateau, our view is that it is a combination of the partial PPAR gamma component of lanifibranor, so not a full agonist. That has important consequences for long-term activation of that sodium channel. Second, and more importantly, the pan-PPAR antagonism brings the alpha and delta components online, and they work to increase not to. The gamma will increase glucose storage via improved insulin sensitization, but the alpha and delta actually get to improved utilization of glucose by tissue. That utilization actually prevents that sugar from being stored, and that you get a sort of metabolic pop from that alpha delta, which helps to keep the scale weight plateauing over time. Again, Prakhar, if you could just get to the last question, the reference part of it, we missed it. Prakhar Agrawal: Yeah. If we remember correctly, a couple of years back, the company had previously shared blinded interim weight gain data, so on a pooled basis from the ongoing phase III. It was interim, but we thought it was a very large sample size. Why should not we use that as a reference for understanding the weight gain profile and the plateau effect and the time point of it for the final analysis in phase III? Thank you so much. Jason Campagna: Sure. You are correct, Prakhar, that several years ago, something like that was done. We think just correcting language, it was no interim read of anything. It was an early look at approximately 100 blinded patients that have achieved week 72. We think to the extent that anyone on the outside world took comfort or not in that, we think those days are in the past. You ask, why do not we do that again? It is our view that utilizing blinded data from a 1,000+ patient clinical trial is fraught with error of interpretation, and it is not something that we think would be helpful. It is more importantly, not something that we are guiding on regardless. Prakhar Agrawal: Got it. Thanks for clarifying. Operator: Thank you. We will now move on to our next question. Our next question comes from the line of Kripa Devarakonda from Truist Securities. Please go ahead. Your line is open. Kripa Devarakonda: Hi, guys. Thank you so much for taking my question and congratulations on all the progress end of year. I have a question on fibrosis expectations. How much importance should we place on not hitting the stat sig endpoint, but on the magnitude of fibrosis improvement independent of the MASH resolution? You talked earlier about lanifibranor's antifibrotic effect. What level of response would convince you that this is a meaningful antifibrotic effect rather than improving metabolic inflammatory component of the disease? Thank you. Andrew Obenshain: Kripa, let me I think I understand the question. We believe 18% improvement is meaningful in fibrosis to basically duplicating our phase II into phase III. With that profile, with an 18% improvement of one stage or more in fibrosis, that is a secondary endpoint for us. We believe that we have those three segments that I discussed, the F3 diabetics or high cardiometabolic risk, the F3 non-diabetics, and the F2 diabetics as segments where that profile is an 18% fibrosis effect, this would be a differentiated product for those patients. Kripa Devarakonda: Thank you. Andrew Obenshain: Yeah. Operator: Thank you. We will move on to our next question. Our next question comes from the line of Rami Katkhuda from LifeSci Capital. Please go ahead. The line is open. Rami Katkhuda: Hi, guys. Thanks for taking my questions as well. Maybe going off a comment Jason made earlier, can you touch on the time course of lani-associated weight gain, particularly the timing of early fluid retention versus later adipose remodeling and when each typically plateaus? Then secondly, I know it is a bit early, but how are you thinking about the design of the confirmatory outcomes trial? Are there any key learnings from ongoing studies that could help inform patient selection? Andrew Obenshain: Yeah, thanks, Rami. So two questions there just on the time course, which I am just going to pre-empt it. We cannot really say much more than we have already said on this call. I think we have answered that question pretty thoroughly. So maybe we could focus Jason on the F4 and the confirmatory study and what we are thinking there. Jason Campagna: Yeah, I am happy to. I think, look, we are looking forward to talking more about the confirmatory study after top line. But I think for now, what we are trying to communicate is, one, that we will be focused on this cACLD, chronic advanced compensated liver disease population, those with clinically significant portal hypertension. We know now that there are very good ways to assess and identify these patients in the wild using non-invasive methodologies like a combination of liver stiffness measurements and platelets. They are captured in criteria that providers use routinely in the care of patients with advanced liver disease. So the inclusion of patients with clinically significant portal hypertension is the goal. Second, you ask what evidence might we have from our clinical program that will inform that trial. Good question. The exploratory cohort I mentioned during the scripted portion of the call, we have approximately 75 to 100 cirrhotic patients in that trial that will have been exposed to lanifibranor for at least 18 months, and if they complete the active treatment extension, they could be on for up to four years. We think that those data from a safety and tolerability perspective and pharmacology will be helpful. Lastly, we have completed nearly a dozen phase I clinical trials with lanifibranor over the years, including dedicated hepatic impairment study in patients with Child-Pugh A, B, and C. The results of those studies, although we have not published them, we are comfortable and confident around the safety of the drug in those phase I trials at the doses we are presently using. When combined with that exploratory cohort of about 75 to 100 patients, we think we will have a really good opportunity to build and conduct a strong outcomes trial in this cACLD population. Rami Katkhuda: Awesome. Thank you, guys. Operator: Thank you. We'll move on to our next question. Our next question comes from the line of Sushila Hernandez from Van Lanschot Kempen. Please go ahead. Your line is open. Sushila Hernandez: Hi, this is Zoe on for Sushila. Thank you so much for taking our question. With the lanifibranor phase III NATiV3 top line readout in MASH expected in the next quarter, we were wondering what kind of data we can expect at the top line. Will there be data on the treatment response in patients on GLP-1 and on SGLT inhibitor or on the weight gain? If I could just ask another question, we're also wondering how do you expect the placebo response to evolve with the longer treatment duration? Thank you. Andrew Obenshain: Great. Thank you, Zoe, for the question. We are not guiding on the top-line data right now. I think as you can tell on this call, we are very well aware of the interest in the endpoints and the tolerability profile elements I'm sure people are interested in seeing. I'm sure we will be looking to address a lot of the questions that were on the call today. However, we're not yet guiding on what's in that readout. In terms of the placebo response, the composite endpoint was deliberately chosen as a primary endpoint, as it controls better for placebo response. It's very difficult for a placebo patient to achieve resolution by themselves on fibrosis and all the clinical endpoints of MASH. Therefore, that was why that placebo rate was chosen. Really, I'm not going to speculate on what the placebo rate will be after an 18-month trial versus a six-month trial, but certainly it's our expectation that having that composite endpoint does help mitigate any fluctuation in placebo rates. Sushila Hernandez: Yeah. Okay. Thank you so much. Operator: We will now go to our last question, and that question comes from the line of Andy Chen from Wolfe Research. Please go ahead. Your line is open. Jason Zhang: Hi. Thank you so much. This is Jason taking it for Andy, and we just wanted to ask another question about GLP-1. Do you guys think the baseline GLP-1 subgroup is large enough to meaningfully assess whether lanifibranor provides incremental histological benefits on top of the therapy? How would that sensitivity analysis be presented? If you could provide some color on that. Thank you. Andrew Obenshain: Yeah. First of all, clarification, the GLP-1s drop-ins that were allowed in the trial were not at the MASH dose. They were at a lower dose. There should be no histological impact of the GLP-1 on the GLP-1. I think that in terms of doing a subset analysis, I think that answers the question that we don't anticipate that there should be a histological effect of the GLP-1. Jason Zhang: Gotcha. Thank you. Andrew Obenshain: Jason, would you add anything to that? Jason Campagna: No, I do, Andrew. Andy, a good question. Just referring you back to earlier in the Q&A around the sensitivity analyses and that this question, the form of the question, how is it that other therapeutics that are dropped into a late-stage clinical trial may affect the primary endpoint? This is routinely handled in phase III trials, not only outside, like in atopic dermatitis and use of steroids, but also within MASH. So the sensitivity analyses that we will run are completely routine and standard for a phase III program facing those kinds of questions. Jason Zhang: Gotcha. Thank you. Operator: Thank you. There are no further questions at this time, so I will hand the call back to Andrew for closing remarks. Andrew Obenshain: Yeah, I want to thank everyone for joining today and for the questions. Inventiva is at an inflection point right now. We are very excited to be approaching the top-line results in Q4 this year and the potential to bring a therapy forward for a large patient population with a large unmet need and bring a new therapy option. Thank you, everyone, for your interest, and we will see you, I think the next time we talk will be on the data release. Thank you. Operator: This concludes today's conference call. Thank you for participating. You may now disconnect. Before you buy stock in Inventiva, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Inventiva wasn't one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $373,352!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $1,406,241!* That performance is why people listen. With a track record of beating the S&P 500 by 4x, Stock Advisor offers a distinct advantage. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built for the long haul. See the 10 stocks » *Stock Advisor returns as of September 29, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Inventiva (IVA) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Related articleQuarter not tagged2026-09-28

Inventiva Reports Unaudited 2026 First-Half Financial Results and Provides Corporate Update

GlobeNewswire
- Cash and cash equivalents at €166.1 million and €67.8 million in short-term deposits1 as of June 30, 2026 - Cash runway guidance remains unchanged from July 30, 20262 - Topline results of the Phase 3 NATiV3 clinical trial are expected in the fourth quarter of 2026 - Key highlights from the first half of 2026 and recent Company updates - Management to host webcast today at 8:00 AM ET to discuss first-half 2026 financial results Daix (France), New York (New York, United States), September 28, 2026 – Inventiva (Euronext Paris and NASDAQ: IVA) ("Inventiva" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of an oral therapy for the treatment of metabolic dysfunction-associated steatohepatitis ("MASH"), today reported its financial information for the first half of 2026, ended June 30, 2026, including its cash position, cash flows and revenues, and provided a corporate update. Key Financial Results for the First Half of 2026 (in thousands of euros) | | Six Months Ended | | June 30, 2026 | | June 30, 2025 Revenues | | 20 | | 4,454 Other income | | 1,286 | | 1,156 Research and development expenses | | (46,238) | | (44,890) Marketing – business development expenses | | (2,589) | | (746) General and administrative expenses | | (22,247) | | (14,713) Other operating income (expenses) | | (619) | | (8,202) Net Operating Loss | | (70,388) | | (62,940) Net Financial Income (Loss) | | 907 | | (113,224) Share of net loss- Equity method and dilution gain | | 117 | | (220) Income tax | | (104) | | 503 Net Loss for the Period | | (69,467) | | (175,882) Basic/diluted loss per share (euros/share) | | (0.25) | | (1.62) Weighted average number of outstanding shares used for computing basic/diluted loss per share | | 273,582,870 | | 108,839,636 There were no revenues recorded for the first half of 2026, compared to €4.5 million generated for the same period in 2025. Revenue recognized in the first half of 2025 was attributable to the 2022 License Agreement with Chia Tai Tianging Pharmaceutical Group Co., Ltd. (as amended and assigned to Chia Tai Tianging (Guangzhou) Co., Ltd). Other income amounted to €1.3 million for the first half of 2026, stable as compared to €1.2 million for the first half of 2025. Other income mainly consisted of the French research tax credit ("Crédit d'Impôt Recherche"). R&D expenses fo…Read full document

- Cash and cash equivalents at €166.1 million and €67.8 million in short-term deposits1 as of June 30, 2026 - Cash runway guidance remains unchanged from July 30, 20262 - Topline results of the Phase 3 NATiV3 clinical trial are expected in the fourth quarter of 2026 - Key highlights from the first half of 2026 and recent Company updates - Management to host webcast today at 8:00 AM ET to discuss first-half 2026 financial results Daix (France), New York (New York, United States), September 28, 2026 – Inventiva (Euronext Paris and NASDAQ: IVA) ("Inventiva" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of an oral therapy for the treatment of metabolic dysfunction-associated steatohepatitis ("MASH"), today reported its financial information for the first half of 2026, ended June 30, 2026, including its cash position, cash flows and revenues, and provided a corporate update. Key Financial Results for the First Half of 2026 (in thousands of euros) | | Six Months Ended | | June 30, 2026 | | June 30, 2025 Revenues | | 20 | | 4,454 Other income | | 1,286 | | 1,156 Research and development expenses | | (46,238) | | (44,890) Marketing – business development expenses | | (2,589) | | (746) General and administrative expenses | | (22,247) | | (14,713) Other operating income (expenses) | | (619) | | (8,202) Net Operating Loss | | (70,388) | | (62,940) Net Financial Income (Loss) | | 907 | | (113,224) Share of net loss- Equity method and dilution gain | | 117 | | (220) Income tax | | (104) | | 503 Net Loss for the Period | | (69,467) | | (175,882) Basic/diluted loss per share (euros/share) | | (0.25) | | (1.62) Weighted average number of outstanding shares used for computing basic/diluted loss per share | | 273,582,870 | | 108,839,636 There were no revenues recorded for the first half of 2026, compared to €4.5 million generated for the same period in 2025. Revenue recognized in the first half of 2025 was attributable to the 2022 License Agreement with Chia Tai Tianging Pharmaceutical Group Co., Ltd. (as amended and assigned to Chia Tai Tianging (Guangzhou) Co., Ltd). Other income amounted to €1.3 million for the first half of 2026, stable as compared to €1.2 million for the first half of 2025. Other income mainly consisted of the French research tax credit ("Crédit d'Impôt Recherche"). R&D expenses for the first half of 2026 amounted to €46.2 million, mainly driven by the clinical development of lanifibranor in MASH, up 3.0% compared to the €44.9 million for the first half of 2025. This increase was in line with operational plan expectations and did not include any preclinical research expenses following the discontinuation of preclinical R&D activities implemented mid-2025. Marketing and business development expenses amounted to €2.6 million for the first half of 2026, compared to €0.7 million for the same period in 2025, primarily reflecting increased personnel costs and expenses related to preparations for the potential commercial development of lanifibranor, if approved. General and administrative expenses (G&A) amounted to €22.2 million in the first half of 2026, compared to €14.7 million in the first half of 2025, an increase of €7.5 million. The change was primarily related to €4.7 million of increase in personnel costs, including share-based compensation expenses, consulting fees and other expenses associated with potential commercial development of lanifibranor, if approved. Net financial income (loss) amounted to €0.9 million in the first half of 2026, compared to (€113.2) million for the same period in 2025. The financial result for the first half of 2026 mainly reflected (i) €16.2 million of non-cash impact from the IFRS fair value accounting of financial instruments entered into in connection with the restructuring of warrants issued to European Investment Bank ("EIB"), the Lenders' Warrants issued to funds and accounts managed by BlackRock and Claret Capital Partners (together, the "Lenders") and the embedded convertible option in the first tranche of €35.0 million of senior secured convertible bonds issued under the June 2026 debt financing with the Lenders for up to €130.0 million (the "Debt Financing"), (ii) €4.8 million of income from cash equivalents and foreign exchange gains (net), and (iii) (€20.0) million of interest and related financial expenses, including (€11.2) million resulting from the repayment of the loan with the EIB and (€7.4) million of interest expense related to the royalty certificates issued in 2023 and 2024. The Company's net loss stood at (€69.5) million as of June 30, 2026, compared to (€175.9) million as of June 30, 2025. As of June 30, 2026, the Company's cash and cash equivalents amounted to €166.1 million and €67.8 million in short-term deposits1, compared to cash and cash equivalents of €99.3 million and €131.6 million in short-term deposits as of December 31, 2025. Net cash used in operating activities amounted to (€45.4) million for the first half of 2026, compared to (€53.7) million for the same period in 2025. The lower cash consumption mainly reflects the favorable working capital change partially offset by the increase in operating expenses relating to the continued advancement of the NATiV3 Phase 3 clinical trial and preparation of pre-commercial activities. Net cash generated from investing activities for the first half of 2026 amounted to €63.8 million, compared to (€24.8) million for the first half of 2025. The increase primarily reflects changes in the Company's short-term deposits, including in connection with the June 2026 comprehensive refinancing transaction3. Net cash generated from financing activities for the first half of 2026 amounted to €47.7 million, compared to €104.8 million for the first half of 2025.The net cash generated from financing activities in the first half of 2026 reflects the comprehensive refinancing transaction announced on June 2, 2026, including the offering of 27,272,727 American Depositary Shares (the "Equity Offering") for €103.0 million and the Tranches A and B of the Debt Financing of €75.0 million, both in gross proceeds. These cash inflows were partially offset by the repayment in full of the existing EIB loans for an aggregate amount of €62.2 million, and the repurchase of all of the warrants issued to EIB in connection with the first tranche of the EIB loans and 700,000 of the warrants issued to EIB in connection with the second tranche of the EIB loans for an aggregate repurchase price of €50.0 million4. The net cash generated from financing activities in the first half of 2025 came from the gross proceeds of €115.6 million (net proceeds of €108.0) of the 2024 Structured Financing5. Based on the Company's existing cash and cash equivalents and short-term deposits, together with the net proceeds from the completed Equity Offering, the completed EIB Transactions and the issuance of Tranches A and B under the Debt Financing Transaction6, the Company expects to be able to finance its operations as currently planned until the end of the second quarter of 2027. At the date of this press release, the Company's current cash and cash equivalents are not sufficient to cover operating needs as currently planned for the next twelve months. If Tranche C of the Debt Financing Transaction3 is issued for potential gross proceeds of up to €55.0 million and the Tranche 3 warrants previously issued by the Company in the Structured Financing5 for potential gross proceeds of up to €116.0 million are exercised in full, the Company expects to be able to finance its operations as currently planned until the start of the first quarter of 20287. Over the first half of 2026, the Company recorded a positive foreign exchange effect on cash and cash equivalents of €0.7 million, compared with a negative effect of (€0.7) million for the first half of 2025, primarily due to the changes in the EUR/USD exchange rate. Corporate Updates - On September 2, 2026, Inventiva announced that the last patient had completed their final 72-week visit in the NATiV3 Phase 3 clinical trial evaluating lanifibranor for the treatment of patients with MASH with moderate and advanced fibrosis8. - NATiV3 enrolled 1,009 adults with biopsy-proven non-cirrhotic MASH and F2/F3 fibrosis, with an additional 410 patients enrolled in an exploratory cohort. - Inventiva expects to report topline results from the Phase 3 clinical trial NATiV3 in the fourth quarter of 2026. - If the NATiV3 topline results are favorable, the Company anticipates regulatory submission in the first half of 2027 and is preparing for a potential U.S. launch of lanifibranor in 2028, subject to U.S. Food and Drug Administration ("FDA") approval. - Since the start of 2026, Inventiva strengthened its leadership team with the appointment of Axel-Sven Malkomes as Chief Financial Officer, Susan Coles, as Chief Legal Officer, Pamela Herbster as Chief People Officer9 and Chris Benecchi, as Chief Operating Officer10. - Barbara Krebs-Pohl, Anne Prener, and Camilla Soenderby, were appointed as independent members of the Company's Board of Directors, effective June 30, 2026, reflecting the additional expertise, international reach, and strategic acumen required to guide the Company through its next phase of development and potential commercialization11. First-Half Financial Results Webcast Inventiva's management will hold a conference call in English, followed by a Q&A session, on Monday, September 28, 2026, at 8:00 AM (New York), 2:00 PM (Paris) to discuss first-half financial results for 2026. Participants wishing to join the conference call by phone and ask questions must register in advance here. Upon registration, participants will receive dial-in details by email. The live webcast may be accessed on the Events section of the Inventiva website. A replay of the conference call will be available after the event on the Company's website. Upcoming Scientific Conference Participation The American Association for the Study of Liver Diseases (AASLD), Denver, CO, November 5-9, 2026. Next Financial Results Publication Revenues and cash and cash equivalents for the third quarter 2026 on Monday November 23, 2026 (before E.U. and U.S. market open). About Lanifibranor Lanifibranor, Inventiva's lead product candidate, is an orally available small molecule that acts to induce antifibrotic, anti-inflammatory and beneficial vascular and metabolic changes in the body by activating all three peroxisome proliferator-activated receptor ("PPAR") isoforms, which are well-characterized nuclear receptor proteins that regulate gene expression. Lanifibranor is a PPAR agonist that is designed to target all three PPAR isoforms in a moderately potent manner, with a well-balanced activation of PPARα and PPARδ, and a partial activation of PPARγ. While there are other PPAR agonists that target only one or two PPAR isoforms for activation, lanifibranor is the only pan-PPAR agonist in clinical development for the treatment of MASH. Inventiva believes that lanifibranor's moderate and balanced pan-PPAR binding profile contributes to the favorable tolerability profile that has been observed in clinical trials and preclinical studies to date. The FDA has granted Breakthrough Therapy and Fast Track designation to lanifibranor for the treatment of MASH. Lanifibranor is an investigational medicine and has not been approved for use by any regulatory authority. Its safety and efficacy have not been established. About Inventiva Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of an orally administered small molecule for the treatment of patients with MASH. The Company is currently evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for the treatment of adult patients with MASH, a common and progressive chronic liver disease. Inventiva is a public company listed on compartment B of the regulated market of Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: IVA). https://www.inventivapharma.com Contacts Investor Relations David Nikodem: [email protected] Media Relations Lisa Buffington: [email protected] Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "believe," "anticipate," "expect," "intend," "plan," "seek," "estimate," "may," "will," "could," "should," "designed," "hope," "target," "potential," "opportunity," "possible," "aim," and "continue" or similar expressions are intended to identify forward-looking statements. All statements, other than statements of historical fact, included in this press release are forward-looking statements. These statements include, but are not limited to, statements concerning the potential therapeutic benefit of lanifibranor, the expected availability and timing of results from NATiV3, the timing of potential regulatory submissions, approvals and commercialization of lanifibranor, Inventiva's cash resources and expenses and ability to obtain additional financial resources, including assumptions and conditions relating thereto with, and Inventiva's future activities, expectations, plans, growth and prospects. Although Inventiva's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that such forward-looking information and statements are subject to various risks, contingencies and uncertainties, many of which are difficult to predict and generally beyond the control of Inventiva, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks, contingencies and uncertainties include, among other things, uncertainties inherent in research and development, clinical data and analysis and decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any product candidates, as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates; Inventiva's reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; Inventiva's ability to achieve milestones; Inventiva's ability to obtain adequate financing to fund its operations and continue as a going concern, including Inventiva's ability to enter into potential transactions on the expected timing or at all, Inventiva's ability to comply with and satisfy the terms and conditions of its financing documents and whether, when and to what extent the securities issued in the Debt Financing and other dilutive instruments, including the Tranche 3 warrants, may be exercised; Inventiva's ability to execute on its strategy, including with respect to commercialization, marketing and manufacturing; potential negative impacts on Inventiva from changes in laws and regulations, unfavorable conditions in its industry, geopolitical events, and ongoing conflicts, health epidemics, and macroeconomic conditions, including developments in international trade policies, global inflation, financial and credit market fluctuations, tariffs and other trade barriers, and the other risks and uncertainties described in Inventiva's Universal Registration Document for the year ended on December 31, 2025 filed with the Autorité des Marchés Financiers on April 8, 2026, Inventiva's Annual Report on Form 20-F for the year ended December 31, 2025 filed with the SEC on April 8, 2026 and Inventiva's Half-Year Report for the fiscal period ended June 30, 2026, filed on Form 6-K on September 28, 2026 including those described under the caption "Risk Factors", and in future filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Inventiva disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that Inventiva becomes aware of, except as required by law. 1 Short-term deposits were included in the category "other current assets" in the IFRS consolidated statement of financial position and were considered by the Company as liquid and easily available. 2 Cf press release of July 30, 2026. 3 Cf press release of June 2, 2026 4 Cf press releases of June 2, 2026, and June 12, 2026. 5 Cf press release of October 13, 2024. 6 Cf press release of June 2, 2026 (please refer to the description of the financial covenants pertaining to the Debt Financing). 7 These estimates are based on the Company's current business plan and assume the successful issuance of Tranche C of the Debt Financing, and the exercise in full of the Tranche 3 warrants previously issued by the Company in the Structured Financing for potential proceeds of up to €116.0 million, and exclude any potential milestones payable to or by the Company and any additional expenditures related to the product candidate or resulting from the potential in licensing or acquisition of additional product candidates or technologies, or any associated development the Company may pursue. The Company may have based these estimates on assumptions that are incorrect, and the Company may end up using its resources sooner than anticipated. These estimates may be shortened in the event of an increase, in expenditure relating to the development programs beyond the Company's expectations, or if the development program progresses more quickly than expected. 8 Cf press release of September 2, 2026. 9 Cf press release of April 22, 2026. 10 Cf press release of August 31, 2026. 11 Cf press release of July 8, 2026. Attachment - Inventiva - PR - H1 2026 Financial Results - EN - 09 28 2026

Related articleQuarter not tagged2026-09-28

Inventiva Q2 Earnings Call Highlights

MarketBeat
- Interested in Inventiva S.A. Sponsored ADR? Here are five stocks we like better. - Inventiva remains on track for a fourth-quarter 2026 readout of its Phase III NATiV3 trial evaluating lanifibranor in MASH, following completion of the final patient's 72-week visit. If results are positive, the company plans a potential U.S. NDA submission in the first half of 2027 and a possible 2028 launch. - NATiV3 enrolled approximately 1,400 patients, with its primary endpoint assessing simultaneous MASH resolution and at least one-stage fibrosis improvement. Management highlighted prior Phase IIb efficacy and said safety concerns such as edema and weight gain were generally mild to moderate, while analyses will examine the impact of GLP-1 and SGLT2 medicines. - Financing is expected to fund operations through the Phase III results and potential filing. Inventiva reported €233.9 million in cash and short-term deposits at June 30, 2026, and expects its runway to extend through the second quarter of 2027, potentially into early 2028 if additional financing conditions are met. Inventiva (NASDAQ:IVA) said it remains on track to report top-line results from its Phase III NATiV3 trial of lanifibranor in metabolic dysfunction-associated steatohepatitis, or MASH, in the fourth quarter of 2026, after the last patient completed the study's 72-week visit earlier this month. Chief Executive Officer Andrew Obenshain said the company is also preparing for a potential U.S. new drug application submission in the first half of 2027, contingent on positive trial data, while building commercial capabilities for a possible 2028 launch. → 3 Defense Stocks Riding Nuclear, Missile, and Aerospace Demand Lanifibranor is a once-daily oral therapy designed to modulate all three peroxisome proliferator-activated receptor, or PPAR, isoforms. Inventiva is developing the drug for MASH, a liver disease associated with metabolic dysfunction that can lead to fibrosis, cirrhosis and other complications. Obenshain said the company believes lanifibranor could address both metabolic factors outside the liver and hepatic drivers such as steatosis, inflammation and fibrosis. He cited the company's prior Phase IIb NATIVE trial, in which lanifibranor showed placebo-adjusted improvements of 18% in fibrosis, 26% in MASH resolution and 24% on a composite endpoint after six months. → Best Buy Is Turning Amazon Fir…Read full document

- Interested in Inventiva S.A. Sponsored ADR? Here are five stocks we like better. - Inventiva remains on track for a fourth-quarter 2026 readout of its Phase III NATiV3 trial evaluating lanifibranor in MASH, following completion of the final patient's 72-week visit. If results are positive, the company plans a potential U.S. NDA submission in the first half of 2027 and a possible 2028 launch. - NATiV3 enrolled approximately 1,400 patients, with its primary endpoint assessing simultaneous MASH resolution and at least one-stage fibrosis improvement. Management highlighted prior Phase IIb efficacy and said safety concerns such as edema and weight gain were generally mild to moderate, while analyses will examine the impact of GLP-1 and SGLT2 medicines. - Financing is expected to fund operations through the Phase III results and potential filing. Inventiva reported €233.9 million in cash and short-term deposits at June 30, 2026, and expects its runway to extend through the second quarter of 2027, potentially into early 2028 if additional financing conditions are met. Inventiva (NASDAQ:IVA) said it remains on track to report top-line results from its Phase III NATiV3 trial of lanifibranor in metabolic dysfunction-associated steatohepatitis, or MASH, in the fourth quarter of 2026, after the last patient completed the study's 72-week visit earlier this month. Chief Executive Officer Andrew Obenshain said the company is also preparing for a potential U.S. new drug application submission in the first half of 2027, contingent on positive trial data, while building commercial capabilities for a possible 2028 launch. → 3 Defense Stocks Riding Nuclear, Missile, and Aerospace Demand Lanifibranor is a once-daily oral therapy designed to modulate all three peroxisome proliferator-activated receptor, or PPAR, isoforms. Inventiva is developing the drug for MASH, a liver disease associated with metabolic dysfunction that can lead to fibrosis, cirrhosis and other complications. Obenshain said the company believes lanifibranor could address both metabolic factors outside the liver and hepatic drivers such as steatosis, inflammation and fibrosis. He cited the company's prior Phase IIb NATIVE trial, in which lanifibranor showed placebo-adjusted improvements of 18% in fibrosis, 26% in MASH resolution and 24% on a composite endpoint after six months. → Best Buy Is Turning Amazon Fire TV Into a New Advertising Opportunity The NATiV3 registrational study enrolled about 1,400 patients in two cohorts. Its main placebo-controlled cohort includes 1,009 patients with biopsy-confirmed, non-cirrhotic MASH and F2 or F3 fibrosis, while an exploratory cohort includes 410 patients with predominantly F1 or F4 disease. Both cohorts received treatment for 72 weeks. The primary endpoint in the main cohort is a composite of MASH resolution and at least a one-stage improvement in fibrosis in the same patient. Secondary endpoints include MASH resolution and fibrosis improvement of at least one stage. Chief Medical Officer and President of Research and Development Jason Campagna said the main cohort is powered at 90% using assumptions more conservative than the efficacy observed in the Phase IIb study. → These 3 Overlooked Stocks Have Big Money Behind Them Campagna said the Phase III population includes a greater prevalence of diabetes, more advanced fibrosis and more use of GLP-1 and SGLT2 medicines than the company's earlier Phase IIb trial. The study was stratified by fibrosis stage and diabetes status. During the question-and-answer session, management addressed investor questions about potential weight gain and edema associated with lanifibranor's PPAR-gamma activity. Campagna said the events observed in the Phase IIb NATIVE study were generally mild to moderate and were not primary drivers of treatment discontinuation. According to Campagna, unadjusted edema prevalence in the Phase IIb trial ranged from 7% to 10% across the two doses, while drug-related edema was about 2%. He contrasted those figures with what he described as edema rates in the mid-20% range for pioglitazone in a similar MASH population. The company said it is not providing additional guidance on blinded weight-gain data from NATiV3 before the top-line release. However, Campagna referenced a prior 48-week scleroderma study involving the same doses, in which weight gain appeared to plateau between weeks 24 and 30. Inventiva is studying two doses in NATiV3. Obenshain said the company could consider bringing both forward commercially if both are statistically significant and the final data support distinct efficacy and tolerability profiles, but he said it was too early to speculate before reviewing the Phase III results. Management also said the NATiV3 protocol does not require a formal management algorithm for weight gain or fluid retention. Investigators may use diuretics or SGLT2 inhibitors if they choose. The company previously reported that its LEGEND study suggested empagliflozin, an SGLT2 inhibitor, mitigated certain gamma-related effects while preserving lanifibranor's metabolic benefit. On potential confounding from concurrent therapies, Campagna said pre-specified sensitivity analyses will evaluate any effects from use of GLP-1 medicines and SGLT2 inhibitors. He said those subgroups were not powered for separate statistical conclusions. Obenshain added that GLP-1 treatments introduced during NATiV3 were at doses below those used for MASH. If NATiV3 produces positive results, Inventiva intends to seek accelerated approval in the U.S. and conditional approval in Europe. The company also plans to initiate a confirmatory clinical outcomes trial in patients with compensated advanced chronic liver disease due to MASH, including patients with clinically significant portal hypertension. Campagna said the exploratory NATiV3 cohort includes approximately 75 to 100 cirrhotic patients who will have received lanifibranor for at least 18 months. Those completing the active-treatment extension could remain on treatment for up to four years, potentially generating additional safety, tolerability and pharmacology information for future studies in more advanced disease. Inventiva reported €233.9 million in combined cash equivalents and short-term deposits as of June 30, 2026. The company said it strengthened its balance sheet through a capital-structure optimization announced in June, including the repurchase of about 60% of European Investment Bank warrants with anti-dilution protection for €50 million and repayment of €63 million in EIB loans. Chief Financial Officer Axel-Sven Malkomes said Inventiva also secured debt financing of up to €130 million in three committed tranches, subject to conditions, plus an uncommitted tranche of up to €20 million. The company completed an underwritten public offering of American depositary shares that generated €103 million in gross proceeds. Under current assumptions, existing resources and completed financing transactions, the company expects its cash runway to extend through the end of the second quarter of 2027, covering the Phase III readout and a potential NDA filing. Malkomes said the runway could extend into the beginning of the first quarter of 2028 if Tranche 3 warrants are fully exercised following positive top-line data and the company completes Tranche C of its debt financing. For the first half of 2026, research and development expenses totaled €46.2 million, while marketing and business development expenses were €2.6 million and general and administrative expenses were €22.2 million. Inventiva SA is a clinical-stage biopharmaceutical company headquartered in Daix, France. The company develops small-molecule therapies for metabolic, liver and autoimmune diseases, with a focus on conditions that have limited treatment options. Inventiva's lead product candidate is lanifibranor, an oral pan-PPAR agonist being developed for metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH). The investigational therapy is intended to address liver inflammation and fibrosis associated with the disease and is being evaluated in late-stage clinical development. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Inventiva Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for September 2026.

TranscriptFY2026 Q22026-09-28

FY2026 Q2 earnings call transcript

Earnings source - 113 paragraphs
Operator

Day, and thank you for standing by. Welcome to Inventiva's first half of 2026 financial results conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. As a reminder, today's conference call is being recorded. I would now like to hand the call over to David Nikodem, Head of Investor Relations for Inventiva. Please go ahead.

David Nikodem

Thank you. Good morning, good afternoon. Thank you for joining Inventiva's first half 2026 financial results and business update. This morning, we issued our press release reporting our full financial results for the first half of 2026. A replay of this webcast will be available in the investor section of our website following the call. Before we begin, a quick reminder that the statements we make today, including during the Q&A, may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements reflect our views only as of today and should not be relied upon at any later date. Please refer to slide two and to our filings with the SEC and the AMF for a discussion of the associated risks.

David Nikodem

Joining me today are Andrew Obenshain, our Chief Executive Officer, Dr. Jason Campagna, our Chief Medical Officer and President of R&D, and Axel-Sven Malkomes, our Chief Financial Officer. Chris Benecchi, our recently appointed Chief Operating Officer, will be joining us for the Q&A portion of the call. With that, I'll turn the call over to Andrew.

Andrew Obenshain

Thank you, David, and welcome everyone. Today, I'll start by providing an update on the company and our priorities. Jason will overview our lanifibranor development program. Axel will walk through our first half of 2026 financial highlights, and then we will open the call for Q&A. The first half of 2026 has been a defining period for Inventiva. We have stayed focused on our near-term objectives, advancing lanifibranor toward the phase III top-line results readout in MASH expected in Q4 2026, preparing for regulatory filing while building the organization to support a potential commercial launch. Let me start with why we believe in the potential of lanifibranor and why a potential new therapy for MASH is so important. It comes down to three key elements, differentiation, late-stage validation, and market opportunity. Let's begin with differentiation.

Andrew Obenshain

MASH is driven by both intrahepatic and extrahepatic processes, and lanifibranor is designed to address both through a single once-daily oral therapy. In our NATIVE phase II-B study, lanifibranor showed improvement across all key histological endpoints. Next is validation. We designed the NATiV3 phase III trial to build on the foundation established in our positive phase II-B study. We look forward to reporting top-line data in the fourth quarter of this year. Finally, market opportunity. The market is being built in front of us. If lanifibranor is approved, we will enter an established therapeutic area with a market potential expected to exceed $15 billion by 2035. However, significant unmet need remains, and this represents a meaningful opportunity for Inventiva to bring a potentially differentiated treatment option with lanifibranor to people diagnosed with MASH, if approved.

Andrew Obenshain

Let me take each in turn and then lay out our priorities for the year ahead. Let's start with differentiation, and it begins with understanding the biology of the disease. MASH is not simply a liver problem. It is the hepatic expression of a broader systemic metabolic dysfunction. As slide six shows, the disease is driven by multiple interconnected pathways, both outside and inside the liver. These include insulin resistance, adipose dysfunction, and dyslipidemia on the extrahepatic side, and steatosis, inflammation, and fibrosis within the liver itself. That has clear implications for treatment. If the disease is driven by several processes at once, there is an opportunity for next-generation treatment to target more than just one driver. That is the unmet need we believe lanifibranor could address if approved.

Andrew Obenshain

Our aim is not only to target the liver, it is to modulate pathways across both the metabolic and hepatic components of the disease and bring a differentiated treatment option to patients with MASH. The differentiated mechanism of lanifibranor modulating both pathways is reflected in compelling clinical data. In our phase II-B study, after six months, lanifibranor delivered an 18% placebo-adjusted improvement in fibrosis, 26% on MASH resolution, and 24% on the composite endpoint. Those results were the foundation for NATiV3, where we are now testing the same approach in a larger control phase III population of patients with F2 and F3. That is what makes NATiV3 so impactful. It was designed to confirm at pivotal scale the biology and activity we observed in our phase II-B study, and we are pursuing this in a market with substantial and growing unmet need.

Andrew Obenshain

As slide eight shows, there are an estimated 18 million Americans living with MASH, yet only 10% are diagnosed. That is changing fast. As the treatment landscape has matured, diagnosis has increased, up roughly 25% versus 2024, and that is translating into a larger population being actively identified and managed. Today, approximately 374,000 patients with F2 or F3 disease are already in treatment or under the care of a physician. The picture is clear. A large prevalent patient population expanding rapidly as awareness and testing improve, and a compelling opportunity for lanifibranor if approved. Turning to slide nine. To see where lanifibranor may fit in the treatment paradigm, it helps to think about MASH in terms of two factors that are top of mind for physicians, the severity of fibrosis and the cardiometabolic factors that can influence the risk of disease progression.

Andrew Obenshain

Put fibrosis on one axis and cardiometabolic risk on the other, and four clinically distinct populations come into view. Start with the lower right quadrant. We have patients with F3 MASH and cardiometabolic risk, such as type 2 diabetes. This is a population with high unmet medical need, where the mechanism of action of lanifibranor could be compelling in that it targets both the liver and the metabolic drivers simultaneously. In our phase II-B trial, lanifibranor demonstrated an 18% placebo-adjusted improvement in fibrosis at just six months. Similarly, in the lower left, although these patients have earlier stage F2 fibrosis, their cardiometabolic risk factors can put them at risk for more rapid disease progression. For these patients, physicians may also want to act urgently, and lanifibranor could potentially offer an opportunity to intervene earlier in the course of the disease if approved. Moving to the top right quadrant.

Andrew Obenshain

By extension, lanifibranor could be well-positioned in patients with F3 fibrosis without significant cardiometabolic risk. Here, the fibrosis itself is the primary concern, and lanifibranor may have the potential to address the underlying liver disease before it progresses. Taken together, these three quadrants represent a large population with significant unmet need, and if approved, we believe lanifibranor has the potential to play an important role in addressing the needs of these patients. With that overview of why we believe in the potential of lanifibranor, let me lay out three key priorities we are focused on to unlock new opportunities for patients with MASH. First, the NATiV3 trial. We remain on track to report top-line data in the fourth quarter of 2026. Earlier this month, the last patient completed their final 72-week visit. The main cohort enrolled 1,009 participants, all with biopsy-confirmed non-cirrhotic MASH and F2 or F3 fibrosis.

Andrew Obenshain

Second, regulatory readiness. We are advancing our preparations now to support a potential NDA submission with the FDA in the first half of 2027, positioning us to move quickly into regulatory interactions if the top-line data read out as positive. Third, commercial readiness. We are building a commercial organization with the depth and breadth of experience with the best in disease products to be ready for the potential launch in 2028. We believe we are moving forward with lanifibranor from a position of strength and with a potential for a differentiated profile, a late-stage validation opportunity with NATiV3, and a significant market opportunity if approved. I am truly energized by the potential to make a real difference for millions of people living with this serious disease. With that, let me hand it over to Jason to take you through the science behind lanifibranor and our clinical program. Jason?

Jason Campagna

Thank you, Andrew, and greetings, everyone. I will spend a few minutes on four aspects of our lanifibranor development program in MASH. One, how lanifibranor is designed to address the spectrum of disease. Two, what we have observed in the positive NATIVE phase II-B clinical trial. Third, how our NATiV3 phase III trial is built to confirm that phase II study. Lastly, where we are thinking of taking the program next. Let me start with the molecule. As Slide 11 shows, lanifibranor is a potential novel new chemical entity, structurally and mechanistically distinct from both fibrates and thiazolidinediones, and recognized by the FDA with both breakthrough therapy and Fast Track designations. It was informed by decades of research on PPAR biology and the development learnings of prior compounds, and it rests on one critical concept, balance.

Jason Campagna

Lanifibranor engages all three PPAR isoforms, alpha, delta, and gamma, in a low-potency balanced manner such that no single receptor biology dominates. It was also engineered to have only partial agonism of the PPAR gamma receptor. The combination of this balanced low-potency pharmacology and partial PPAR gamma agonism are the keys to our differentiation. It is what lets lanifibranor modulate in harmony the metabolic, inflammatory, and anti-fibrotic pathways of MASH combined rather than forcing one mechanism or receptor at the expense of the others. The two charts on the right illustrate this designed pharmacology. On the first panel, we see the balanced activation profile and the approximately 80% gamma activation with lanifibranor. While on the far right, the cofactor recruitment fingerprint that sets lanifibranor apart from full TZD gamma agonists.

Jason Campagna

The result is a once-daily oral therapy intended to deliver a physiologic balance between achieving pan-PPAR activation and avoiding any one receptor dominance. Moving now to our phase II-B NATIVE clinical trial data. Andrew shared our overall histology efficacy data, but that included patients with lower risk earlier F1 disease. When we exclude these patients with earlier stage disease, we continue to see robust effects across all three histologic endpoints, showing that the drug worked equally well in both early and later stage disease. These results were achieved after only six months of treatment. Looking more closely at the data for the composite endpoint, you can see that treated patients were roughly eight times more likely than placebo patients to achieve dual histologic improvement in the type 2 diabetes subgroup.

Jason Campagna

This tells us that spontaneous regression of the disease was uncommon and that the treatment effect of lanifibranor was strong. Together with the early and late-stage data, these results underscore the potential of lanifibranor to perform across the disease spectrum, including in patients with the most urgent disease. Let me now turn to safety and tolerability. On slide 13, we show the most frequently reported adverse events by investigators in our NATIVE phase II-B clinical trial. Lanifibranor was generally well-tolerated across the totality of our phase II program, but the adverse event profile in NATIVE IIb tracked closely with the underlying scientific design of lanifibranor. Consistent with our preclinical toxicology data, we saw minimal classic alpha or delta toxicities. On gamma-related effects, weight gain, edema, and hemoglobin decline, these were present but attenuated relative to the full TZD class gamma agonists.

Jason Campagna

The weight gain we observed in patients treated with lanifibranor is biphasic. Early on, the partial PPAR gamma activation acts on a sodium channel in the kidney, resulting in sodium and water retention. While in a later phase, that same partial PPAR gamma activation drives improved insulin sensitization and adipose remodeling, reflected in the rise in adiponectin, which is itself tied to histologic efficacy. Both phases are consistent with the known pharmacology of PPAR gamma engagement. Based on our LEGEND study, these gamma-related effects were mitigated by adding an SGLT2 inhibitor, empagliflozin, while also preserving the metabolic benefit of lanifibranor. This brings me to NATiV3. This is a phase III global registrational trial, and it was deliberately designed to build on our phase II-B. The same two doses, a similar patient population, and a primary composite endpoint of MASH resolution and at least one-stage fibrosis improvement in the same patient.

Jason Campagna

Secondary endpoints include MASH resolution and fibrosis improvement of one stage or more. The trial enrolled approximately 1,400 patients across two cohorts, a placebo-controlled randomized portion consisting of 1,009 patients with biopsy-confirmed F2 or F3 MASH, and an exploratory cohort of 410 patients with predominantly F1 or F4 disease. Both cohorts were treated for 72 weeks. All patients who completed the trial are eligible for an active treatment extension to support a longer-term view of the safety and tolerability of lanifibranor. The main cohort will serve as the basis for global marketing registration, and the primary endpoint is powered at 90% on deliberately conservative assumptions with a higher placebo response and a lower treatment effect than we observed in the phase II-B NATIVE trial. It is stratified by fibrosis stage and diabetes status. This main cohort also reflects the real world.

Jason Campagna

The NATiV3 population is a contemporary MASH population with higher diabetes prevalence, more advanced fibrosis, and more use of GLP-1s and SGLT2 inhibitors compared to our phase II-B trial. As Andrew noted, it has been fully recruited, and the last patient visit for the week 72 portion of the trial was completed earlier this month. As Andrew shared, we are excited for top-line data in the fourth quarter of this year. Subject to positive phase III results, we intend to file for accelerated approval with the FDA and conditional approval with the EMA. We will also be initiating a confirmatory clinical outcomes trial designed to evaluate the effects of lanifibranor in patients with more advanced disease. That's worth pausing on because everything I've described targets the core pathophysiology of MASH. That same pathophysiology also underlies compensated advanced chronic liver disease, or cACLD, due to MASH.

Jason Campagna

These are patients who have progressed to advanced fibrosis or early histologic cirrhosis, yet they remain clinically compensated but have evidence of clinically significant portal hypertension, the primary driver of adverse liver-related outcomes. This subgroup of patients has no approved disease-modifying therapy. It is a significant area of high unmet need in the disease. We believe that lanifibranor is mechanistically compelling in cACLD because the same PPAR isoforms that drive the histologic and metabolic effect in the non-cirrhotic MASH population also act on the vascular biology that underpins portal hypertension in this more advanced group. In cACLD, portal pressure matters because as the disease advances, portal hypertension and not fibrosis alone becomes a key driver of these hard clinical outcomes, including bleeding, ascites, and liver transplant. We recently published an analysis of our phase II-B NATIVE trial showing a correlation in patient biopsies with vascular remodeling we've observed preclinically.

Jason Campagna

These are exploratory analysis, but they add to our conviction to pursue further advanced disease states in MASH. With that, I'll hand it over to Axel.

Andrew Obenshain

I will pick up for Axel here.

Axel-Sven Malkomes

I'm sorry, I lost my text. Please go ahead.

Andrew Obenshain

Yes. This morning we issued our press release reporting our full financial results for the first half of 2026. Axel will focus on the key financial highlights and our financial position as we approach the NATiV3 top line readout. Axel, are you ready to take over?

Axel-Sven Malkomes

Not yet.

Andrew Obenshain

Okay. As of June 30, 2026, we had EUR 233.9 million of combined cash equivalents, and short-term deposits. We significantly strengthened our financial position through the comprehensive capital structure optimization that we announced in June. Under that, we bought back approximately 60% of the EIB warrants with anti-dilution protection for EUR 50 million, and repaid our EIB loans for EUR 63 million. In addition, the remaining EIB warrants with anti-dilution protection were canceled. Inventiva issued new EIB warrants in exchange, as described in the July 9, 2026, press release.

Axel-Sven Malkomes

I am ready to take over.

Andrew Obenshain

Please go ahead.

Axel-Sven Malkomes

As part of this optimization, we secured new debt financing of up to EUR 130 million in three committed tranches, subject to conditions with an initial drawdown of two tranches of EUR 75 million gross, plus an additional uncommitted tranche of up to EUR 20 million, as described in our press release of June 2, issued earlier this year. We also completed an underwritten public offering of our American depositary shares, generating gross proceeds of EUR 103 million. Together, these actions strengthened our balance sheet, extended the maturity of our debt, and simplified our capital structure. Our current financing assumptions, existing resources, and completed financing transactions provide cash runway until the end of the second quarter of 2027, seeing us through key milestones, the phase III top-line data readout, and potential NDA filing.

Axel-Sven Malkomes

Assuming full exercise of Tranche 3 warrants on the back of a positive top-line result, as well as successful completion of Tranche C of the debt financing transaction, our cash runway would extend to the start of the first quarter of 2028. R&D expenses were EUR 46.2 million in the first half of 2026, brought in line with the prior year and reflecting continued clinical development of lanifibranor MASH. Marketing and business development expenses increased to EUR 2.6 million, and G&A expenses increased to EUR 22.2 million. Overall, we entered the second half of 2026 with a strengthened balance sheet and financial visibility for the company. With that, I'll turn the floor back to Andrew for his closing remarks.

Andrew Obenshain

Thank you, Axel. This is truly an exciting time for Inventiva. Our differentiated mechanism of action, the results we saw in the NATIVE phase II-B trial, and the robust design of our NATiV3 phase III trial provide a strong foundation as we approach the milestones ahead. The next major milestone is our NATiV3 top-line results readout, expected in the fourth quarter of this year. If positive, it could support the U.S. regulatory filing in the first half of 2027 and a potential EU filing to follow. If approved, we're prepared for a potential U.S. commercial launch in 2028, with the goal of bringing a new treatment option to patients with significant unmet need. We also expect to initiate an outcomes trial, which could support a potential opportunity for lanifibranor to expand into more advanced disease populations. Stepping back, what does this all mean for lanifibranor?

Andrew Obenshain

Let me bring it back to where I started. Why lanifibranor and why now? Lanifibranor is designed to target both the metabolic and hepatic drivers of MASH in one oral medicine. Our pivotal top-line results readout is imminent in Q4 this year. The market is established and significant unmet need remains. We have established the foundation to build a launch-ready organization and prepare for the next stage of development. We are moving forward from a position of strength with the discipline and the urgency that people living with MASH deserve, and I'm genuinely excited about what lies ahead. With that, let me hand it back to the operator to begin Q&A. Operator?

Operator

Thank you. We will now open lines for questions. To ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. You are kindly asked to limit yourself to one question and one follow-up. If you wish to ask any further questions, you may re-enter the queue. We'll now move to our first question. Our first question comes from the line of Yasmeen Rahimi from Piper Sandler. Please go ahead. Your line is open.

Yasmeen Rahimi

Good morning, team. Congrats on all the updates and thank you so much for walking us through some of the key questions. Maybe, we've been lately getting questions from investors how we should be thinking about the two doses in the NATiV3 study, and whether it would even make sense commercially if both showed a clinically meaningful difference to move forward. Would love to get your thoughts. Maybe one other one that sometimes comes up is that the higher dose had a phenomenal histological benefit, but then when we compare the NITs, the two doses look more the same. Would love if you could maybe comment on both. That would be very helpful as it's on top of a few of the investors that have been asking us that. Thank you.

Andrew Obenshain

Thank you, Yasmeen, and good morning. So two questions in there. First one, I think more of a commercial question, which I'll take, then I'll pass it on for the correlation with histology and dose to Jason in a second. First, if both doses are statistically significant positive, I think it would make sense to bring both forward in the market. It's going to depend on the data. So we'll clearly look at what the efficacy is with each dose and the tolerability with each dose. There could be scenarios in which the difference between the two makes sense to bring both to the market, potentially one for two patients or one you could think of as earlier stage patients that are less urgent and so therefore would be okay with a dose response or lower efficacy and more tolerable.

Andrew Obenshain

If another one, if you have a tolerability difference between low and high, then a higher dose with still tolerable but a slightly different profile, we could see bringing both forward, but that really remains to see in the data. It's a little bit too early to speculate until we get the actual data to see it. Jason, let me hand the second question over to you, the correlation with NITs.

Jason Campagna

Sure. Happy to. Yasmeen, good morning. So in the NATIVE phase II trial, generally speaking, the histology endpoints tracked well with most, but not all of the clinical biomarker endpoints. Obviously, ALT/AST reduction was evidenced. This reflects hepatocellular injury. Moving into fibrosis, you can think of the data that we had as looking at both new scar being laid down and active scar resorption. Pro-C3 is the best example of new scar being laid down. It's a fragment of procollagen peptide, and the Pro-C3 marker actually tracked quite nicely with the 1,200 milligram histology efficacy endpoint. Similarly, when we look at ELF, the hyaluronic acid was a little noisy at baseline, but the two other components actually tracked very nicely in a dose-dependent manner, representing that we were, in this case, resorbing some existing scar.

Jason Campagna

Lastly, on the TE, it's very difficult to compare trials, Yasmeen, as you know, across different sponsors. When you look at the data ranging from six months to 18 months, the range in TE liver stiffness measurement ranges from about a 1% placebo-adjusted change all the way up to like a high, sorry, 1 kPa up to a high of 3 kPa. So that's somewhere around 10%-30%. Lanifibranor came in at the lower end of that range, and it's our belief that's, one, it's just early in the disease to really have movement on liver stiffness. It's a composite view of what's going on in the liver. More importantly, we know that lanifibranor has some confounding due to that fluid retention.

Jason Campagna

This is a known concern with liver stiffness in general, listed in the Echosens manuals about being cautious about getting liver stiffness data after a meal or in the presence of fluid loading. At six months, the dynamic fluid flux that's still happening due to the PPAR, we believe is likely impacting some of that. So we landed at about a 10% reduction in liver stiffness, about a 1 kPa placebo-adjusted number. We're confident that with a longer treatment duration, the underlying fibrosis improvements will, in the end, dominate that signal by 18 months.

Yasmeen Rahimi

Thank you so much.

Operator

Thank you. We'll now move on to our next question. Our next question comes from the line of Seamus Fernandez from Guggenheim Securities. Please go ahead. Your line is open.

Seamus Fernandez

Oh, great. Thanks for the question. Just wanted to get a sense of the information that you guys have on a blinded basis as it relates to weight gain throughout the NATiV3 study. If you might be able to share what's with your expectations for potential weight gain. What we've heard from thought leaders is 18% would be a highly differentiated threshold for fibrosis change, very consistent with what you've commented on. But I think there is the trade-off of potential weight gain and edema that some physicians have commented on and may have a higher bar for fibrosis difference over time. Just interested to know what information you guys have on the weight gain and edema, how patients actually feel on drug that has any meaningful impact on the durability and sustainability of the use of lanifibranor in the NATiV3 study. Thanks so much.

Andrew Obenshain

Yeah. A couple elements to that question. Let me hand it to Jason to talk about the first part, which is what have we shown from a blinded basis from the phase III trial on weight gain, and then I can take it from there. Jason, go ahead.

Jason Campagna

Yeah, sure. Seamus, good morning. We previously disclosed back when the structured financing back in 2024, some data on our phase II clinical trial in the scleroderma population. This is a non-metabolic population treated for a year with the same doses of lanifibranor that are in the MASH program. In that trial, we showed that the weight gain was similar up to six months to what we saw in the NATIVE phase II-B trial and thereafter, where NATIVE II-B stopped at six months. Thereafter, the weight gain appeared to plateau right around the week 24 to week 30 and remained stable there out through to the end of the study at week 48.

Jason Campagna

We're not guiding any additional data or input on NATiV3 in any manner. I think, Andrew, to turn this over to you, I think that the data that we have in NATIVE is actually really representative of some of the questions Seamus asked, and I'll answer that and turn it back to you. Seamus, you're really getting at what's the potential impact of things like weight gain, edema? I think that that's the right question. When you look in the NATIVE trial, about half of all patients in that trial had no weight gain defined as anything beyond plus or minus 5%. Among the patients, therefore, that did have weight gain, when you look at the adverse event reporting in that trial, only about 10% of the reports related to weight gain.

Jason Campagna

That is consistent with the idea that weight gain is not seen by patients or providers as a safety or tolerability concern. And in that trial, we had about 30 approximately dropouts, and weight gain was not a primary driver of the tolerability concern there and discontinuing treatment. So our view is that at least from the completed NATIVE clinical trial, that weight gain is not an impediment to patients staying on treatment. And the perception of weight gain by both providers and patients is not one around safety and tolerability. Andrew, over to you.

Andrew Obenshain

Well, I do not think I could say it better than you, Jason. That was perfect. I think we can move on to the next question.

Operator

Thank you. And our next question comes from the line of Ritu Baral from TD Cowen. Please go ahead. Your line is open.

Ritu Baral

Good morning, guys. Thanks for taking the question. I guess I have the same question, in terms of edema, which is, I guess, related but separate in the sense that, I think KOLs see that less as a true safety issue, but potentially a tolerability issue. Is this something you guys have interrogated in your market research insofar as what level and severity that the edema becomes inconvenient or unacceptable to MASH patients and that risk-benefit around sort of extremitous edema, versus any potential issue of fluid load. Thanks.

Andrew Obenshain

I will start out, then I will hand it to Jason as well. A very similar answer to before. The edema is mechanistically understood, is consistent with known PPAR gamma pharmacology. That makes physicians, especially those who use pioglitazone in the market, very comfortable with managing those types of effects. We are looking for in the larger NATiV3 data set to provide a more comprehensive safety characterization overall. But in general, the physicians know that they can mitigate the MFX linked to fluid retention, weight, edema, hemoglobin, by addition of an SGLT2, if they want to manage it. We do view this as a profile that is very commercially attractive. Jason, do you have anything to add to that?

Jason Campagna

I do just briefly. Edema, as Andrew mentioned, is a known on-target consequence of PPAR gamma. I want to make a distinction between the prevalence of edema in the NATIVE II trial, the unadjusted prevalence, meaning independent of assessment, ranged between 7% and 10% on the two doses, and the drug-related edema was about 2%. Contrast that with what we know from pioglitazone in a similar MASH population, you are somewhere in the mid 20s, 20%-25% edema range. So that is a prevalence. In terms of the severity, which I think, Ritu, was where your question was headed, is that generally these events are considered mild to moderate. Going back to the NATIVE II-B clinical trial, these were not primary drivers of patients discontinuing treatment. Most of the edema in the experience of our clinical program is so-called peripheral edema.

Jason Campagna

It happens in the lower extremities, where present occasionally periorbital around the eyes, but generally this is a mild to moderate view. Most importantly, the difference between a pure PPAR agonist like pioglitazone, for example, is fairly large, which is consistent with our view that this is a more blunted or more attenuated gamma effect that you would see with a full TZD class agonist.

Ritu Baral

Would you expect it to be transient?

Jason Campagna

I'm sorry, Ritu, do I expect it to be?

Ritu Baral

Sorry. Would you expect the edema to be transient, and if so, would it be during the full 18 months, and would that be communicated?

Jason Campagna

I think we're not giving any guidance on what we expect over time. I think that 18-month trials are long. The fluid is due to salt and water. To the extent that patients may or may not have already on a pre-existing agent like SGLT2s or thiazide diuretics, that may impact it. Also mild changes in diet around salt intake and/or fluid can impact that. I think our view is that the pharmacology is well understood here and the overall mechanism, and that going back to your core point, we don't view it as a tolerability concern or gating in any way to patients staying on it. Maybe I'll make the simple point. Pioglitazone is a generic therapeutic at this point. It's still used about 4 million scripts a year in the U.S., and that's with very minimal histologic efficacy on anything outside of MASH.

Jason Campagna

I think the question you're really asking is, if we added an 18% one-stage improvement of fibrosis or more to that profile, would people use more or less of it? I would argue they would use more. I think even better evidence that it's much less of a tolerability concern in the market than we see it in the clinical program.

Ritu Baral

Understood. Thank you.

Operator

Thank you. We will now move on to our next question. The next question comes from Thomas Smith from Leerink Partners. Please go ahead. Your line is open.

Thomas Smith

Hey guys, good morning. Congrats on the progress and thanks for taking our questions. First, from a compliance perspective, can you just remind us, is there any protocol or counseling that is built into the study for patients that are experiencing weight gain or edema to help them manage this and stay on the study? Also wondering if you have any visibility into the proportion of patients who have rolled over into the active treatment extension portion of NATiV3 on a blinded basis. Then just a bit on your market research. You highlighted the 374,000 F2, F3 patients diagnosed under the care of a specialist. That is a bit lower than the 460,000 we have heard from a competitor. I was just wondering if you could talk a little bit about the differences there and how you are thinking about patient targeting relative to Rezdiffra. Thanks so much.

Andrew Obenshain

Yeah. Thanks for the question, Thomas. Let me handle the first two, then hand it over to Jason. On the active treatment role, we are not commenting on that yet. We have not publicly disclosed that information. On the patient population, yes, there are some range of estimates out there. The 374,000 is certainly on the low end of that. We have not updated that number, but certainly, I think the real message here is that it is a very sizable population, and growing rapidly. So that number will continue to evolve. Jason, over to you on how weight gain was managed in the trial.

Jason Campagna

Yeah. Thomas, good morning. Good question. There's no formal management algorithm or treatment algorithm in the NATiV3 protocol. However, investigators are educated as to the mechanism. Generally, once they know that the protocol does allow them, if they choose to manage the weight gain, the fluid retention with the use of either diuretics or SGLT2s. Keep in mind, patients in this population are already on, many of them are already on diuretics for hypertension control, et cetera. So the providers have the opportunity to utilize therapeutics that may already be in use to manage, but there's no formal management algorithm that they're required to follow.

Thomas Smith

Understood. Super helpful. Thanks, guys. Looking forward to the data.

Andrew Obenshain

Yep.

Operator

Thank you. We'll now move on to our next question. Our next question comes from the line of Michael Yee from UBS. Please go ahead. Your line is open.

Kyle Yang

Hey, guys. Good morning. This is Kyle Yang for Michael Yee. Just two for us. The first one is on the F2, F3 mix. We did notice that NATiV3 enrolled a meaningfully higher proportion of F3 patients relative to NATIVE phase II-B. How do you expect that to impact both efficacy on the drug arms and placebo arm? The second question is on GLP-1 drop-ins. You previously disclosed roughly 10% GLP-1 dropping rates during this study. How do you think that could potentially impact the outcomes on both the drug arms and placebo? Thank you.

Andrew Obenshain

Yeah, absolutely. Let me just set the stage. I am going to hand it over to Jason to answer that. On the F2, F3, the mix was indeed different in the phase III. We enrolled more patients in the U.S. in the phase III than we did in the phase II. The patient population looks a little bit different in the U.S. There is more diabetes, and diabetes and F3 track together. Therefore, we had slightly more diabetic patients and slightly more F3 patients in the study. We have looked at our phase II when next time we removed the F1 patients from our phase II.

Andrew Obenshain

We saw a slightly better response rate in the F2 and F3 combined than we saw in when it was combined with the F1, which gives us confidence that we are going into at least a drop in the F1s from the study will not impact the patient population. I will have Jason comment in a second just on the split in F2 and F3. On the 10% drop-ins, it is actually 9% drop-ins on GLP-1s. We do not anticipate that to impact the trial as when they dropped in, they drop in on the non-MASH dose. They have dropped in on a lower dose. Jason, over to you.

Jason Campagna

Yeah. Thank you, Andrew. Just adding on to Andrew's response there around F2, F3. I agree. We do not have any expectation that the larger prevalence of F3 patients should impact the primary efficacy readout. I think three additional reasons. One, there is nothing in the biology of F2 or F3 disease that is different from each other. It is just a more advanced version of the exact same biology. I think second, that lanifibranor has direct anti-fibrotic actions to hepatic stellate cells in the liver. That direct action, meaning it does not depend on extra hepatic elements in order to achieve fibrosis. Things like weight loss or glucose metabolism, they are additive, but they are not required for fibrosis improvement. Third, the time duration of the trial actually will help to this extent.

Jason Campagna

I think clearly, if the biology takes more time in an F3 patient to resolve, which is not unreasonable, a longer clinical trial should give us visibility into that. So we are pretty comfortable with that 18-month duration for NATiV3. Lastly, the FGF21 analogues like efruxifermin have shown similar efficacy in F2, F3, and I highlight them because those drugs, although very different mechanism of action, they actually have similar impact on both intra and extrahepatic drivers to some degree. So although not a complete overlap with pan-PPAR agonists, there are some elements that do, and I think that is support for the fact that by getting both direct action in the liver and modulating some extrahepatic drivers of disease, this difference between F2, F3 is unlikely to be a concern.

Operator

Thank you. We will now move on to our next question. Our next question comes from the line of Annabel Samimy from Stifel. Please go ahead. Your line is open.

Annabel Samimy

Hi. Thanks for taking my questions. I guess one question, with the patients on the GLP-1s and SGLT2s, are there any pre-specified analyses of these patients? Are any of those subgroups powered to show any kind of difference or statistical analysis on how those patients perform with that background of GLP-1s or SGLT2s? I guess you touched on this before, but how you might account for any changes in the background mid-trial. Then how might that inform physicians on how to incorporate these drugs? Is there any specific protocol that you would be recommending going forward?

Andrew Obenshain

Thank you, Annabel, for the question. On the second, it is a little bit too early to comment on any sort of guidance to physicians by Inventiva post data. Let me go for the first part. Jason, let me hand it to you.

Jason Campagna

Sure. There are several questions there. Let us go through it. Yes, there are sensitivity analyses that we have pre-specified in the SAP to allow us to look at the impact, if any. Again, as Andrew said, we do not expect any, but the analyses are there on the use of these non-MASH dose of GLP-1s and the use of SGLT2s. I think second, no, none of those groups are in any way powered. We are powered on our primary endpoint. That is the intent of the trial. As I have mentioned before, the power in detail there. Third, I think the important point I think we want to convey here is that there is nothing unusual or different that we are doing in this phase III trial than any other sponsor in any other phase III trial would do to account for therapeutic drop-ins.

Jason Campagna

Even in the case of MASH, if you go back to Intercept's REGENERATE trial, the questions in that era were, what about statins and what about other antidiabetic drugs? Liraglutide had shown in the LEAN study that there was evidence that it could work. Pioglitazone. The answers there were the same answers here, that for any drop-in that may theoretically impact your concern for efficacy, sensitivity analyses are built in to give us and FDA confidence that the treatment effect we see is due to lanifibranor and not due to any other agent that may be dropped in during the course of the trial.

Annabel Samimy

Okay, great. That's helpful. If I can ask one more quick follow-up for Axel. How are you guys preparing for the launch, and have you laid out what kind of funds you might need for the launch?

Andrew Obenshain

Axel, go ahead.

Axel-Sven Malkomes

Yeah, sure. Let's take a step back. We have done our capital transaction, as you all know, in June of this year, which gives us a solid funding until the end of Q2 2027. If we would have positive data, and we could, in addition, add the financing out of the structured financing Tranche 3 as well as the Tranche C out of the refinancing, we would extend that cash runway until the start of the beginning of Q1 2028. So with that, we basically can fund the following catalysts. Point one, the data read out now in Q4. Point two, we are funded until the NDA filing. On top of that, we do not guide on any future raises. But with what we currently have, we believe we have strengthened the balance sheet, simplified the cap structure, prolonged the debt maturity.

Axel-Sven Malkomes

And with that, we are basically solidly financed prior to the data release.

Annabel Samimy

Okay. Thank you.

Operator

Thank you. We will now move on to our next question. Our next question comes from the line of Prakhar Agrawal from Cantor. Please go ahead. Your line is open.

Prakhar Agrawal

Hi. Thank you so much for taking my questions, and congratulations on all the progress. Maybe I had a couple of questions. Firstly, can you talk about the biopsy completion rate in the trial and whether that is tracking in line with some of the recent phase III MASH trials? A couple on weight gain. Maybe mechanistically, why does the weight gain plateau for lanifibranor and not for PPAR gamma pioglitazone? If I remember correctly, I think the company had previously shared interim weight gain data from the ongoing phase III a couple of years back. Realize it was interim, but was a decent enough sample size. So why should not we use that as a reference for understanding what the weight gain profile could look like in the final analysis in the phase III? Thank you so much for taking my questions.

Andrew Obenshain

Yeah. Thank you for the questions, Prakhar. We will address the, you asked about a biopsy completion rate. What we have guided on publicly is a dropout rate for the trial overall. We powered the trial such that we could tolerate up to a 30% dropout rate in the trial. We have guided in, we believe it was April and May 2005, that dropout rate was below 30%, and we confirmed that that dropout rate is comfortably below 30% at that time. We are not giving more guidance beyond that. Regarding the weight gain, you had a question about the plateau and the difference pioglitazone. We are hoping Jason picked it up to be able to talk about both those points. Jason, go ahead.

Jason Campagna

Yeah, we agree. Prakhar, we will come back to the reference. We missed that. On the question of plateau, our view is that it is a combination of the partial PPAR gamma component of lanifibranor, so not a full agonist. That has important consequences for long-term activation of that sodium channel. Second, and more importantly, the pan-PPAR antagonism brings the alpha and delta components online, and they work to increase not to. The gamma will increase glucose storage via improved insulin sensitization, but the alpha and delta actually get to improved utilization of glucose by tissue. That utilization actually prevents that sugar from being stored, and that you get a sort of metabolic pop from that alpha delta, which helps to keep the scale weight plateauing over time. Again, Prakhar, if you could just get to the last question, the reference part of it, we missed it.

Prakhar Agrawal

Yeah. If we remember correctly, a couple of years back, the company had previously shared blinded interim weight gain data, so on a pooled basis from the ongoing phase III. It was interim, but we thought it was a very large sample size. Why should not we use that as a reference for understanding the weight gain profile and the plateau effect and the time point of it for the final analysis in phase III? Thank you so much.

Jason Campagna

Sure. You are correct, Prakhar, that several years ago, something like that was done. We think just correcting language, it was no interim read of anything. It was an early look at approximately 100 blinded patients that have achieved week 72. We think to the extent that anyone on the outside world took comfort or not in that, we think those days are in the past. You ask, why do not we do that again? It is our view that utilizing blinded data from a 1,000+ patient clinical trial is fraught with error of interpretation, and it is not something that we think would be helpful. It is more importantly, not something that we are guiding on regardless.

Prakhar Agrawal

Got it. Thanks for clarifying.

Operator

Thank you. We will now move on to our next question. Our next question comes from the line of Kripa Devarakonda from Truist Securities. Please go ahead. Your line is open.

Kripa Devarakonda

Hi, guys. Thank you so much for taking my question and congratulations on all the progress end of year. I have a question on fibrosis expectations. How much importance should we place on not hitting the stat sig endpoint, but on the magnitude of fibrosis improvement independent of the MASH resolution? You talked earlier about lanifibranor's antifibrotic effect. What level of response would convince you that this is a meaningful antifibrotic effect rather than improving metabolic inflammatory component of the disease? Thank you.

Andrew Obenshain

Kripa, let me I think I understand the question. We believe 18% improvement is meaningful in fibrosis to basically duplicating our phase II into phase III. With that profile, with an 18% improvement of one stage or more in fibrosis, that is a secondary endpoint for us. We believe that we have those three segments that I discussed, the F3 diabetics or high cardiometabolic risk, the F3 non-diabetics, and the F2 diabetics as segments where that profile is an 18% fibrosis effect, this would be a differentiated product for those patients.

Kripa Devarakonda

Thank you.

Andrew Obenshain

Yeah.

Operator

Thank you. We will move on to our next question. Our next question comes from the line of Rami Katkhuda from LifeSci Capital. Please go ahead. The line is open.

Rami Katkhuda

Hi, guys. Thanks for taking my questions as well. Maybe going off a comment Jason made earlier, can you touch on the time course of lani-associated weight gain, particularly the timing of early fluid retention versus later adipose remodeling and when each typically plateaus? Then secondly, I know it is a bit early, but how are you thinking about the design of the confirmatory outcomes trial? Are there any key learnings from ongoing studies that could help inform patient selection?

Andrew Obenshain

Yeah, thanks, Rami. So two questions there just on the time course, which I am just going to preempt it. We cannot really say much more than we have already said on this call. I think we have answered that question pretty thoroughly. So maybe we could focus Jason on the F4 and the confirmatory study and what we are thinking there.

Jason Campagna

Yeah, I am happy to. I think, look, we are looking forward to talking more about the confirmatory study after top line. But I think for now, what we are trying to communicate is, one, that we will be focused on this cACLD, chronic advanced compensated liver disease population, those with clinically significant portal hypertension. We know now that there are very good ways to assess and identify these patients in the wild using non-invasive methodologies like a combination of liver stiffness measurements and platelets. They are captured in criteria that providers use routinely in the care of patients with advanced liver disease. So the inclusion of patients with clinically significant portal hypertension is the goal. Second, you ask what evidence might we have from our clinical program that will inform that trial. Good question.

Jason Campagna

The exploratory cohort I mentioned during the scripted portion of the call, we have approximately 75 to 100 cirrhotic patients in that trial that will have been exposed to lanifibranor for at least 18 months, and if they complete the active treatment extension, they could be on for up to four years. We think that those data from a safety and tolerability perspective and pharmacology will be helpful. Lastly, we have completed nearly a dozen phase I clinical trials with lanifibranor over the years, including dedicated hepatic impairment study in patients with Child-Pugh A, B, and C. The results of those studies, although we have not published them, we are comfortable and confident around the safety of the drug in those phase I trials at the doses we are presently using.

Jason Campagna

When combined with that exploratory cohort of about 75 to 100 patients, we think we will have a really good opportunity to build and conduct a strong outcomes trial in this cACLD population.

Rami Katkhuda

Awesome. Thank you, guys.

Operator

Thank you. We'll move on to our next question. Our next question comes from the line of Sushila Hernandez from Van Lanschot Kempen. Please go ahead. Your line is open.

Speaker 14

Hi, this is Zoe on for Sushila. Thank you so much for taking our question. With the lanifibranor phase III NATiV3 top line readout in MASH expected in the next quarter, we were wondering what kind of data we can expect at the top line. Will there be data on the treatment response in patients on GLP-1 and on SGLT inhibitor or on the weight gain? If I could just ask another question, we're also wondering how do you expect the placebo response to evolve with the longer treatment duration? Thank you.

Andrew Obenshain

Great. Thank you, Zoe, for the question. We are not guiding on the top-line data right now. I think as you can tell on this call, we are very well aware of the interest in the endpoints and the tolerability profile elements I'm sure people are interested in seeing. I'm sure we will be looking to address a lot of the questions that were on the call today. However, we're not yet guiding on what's in that readout. In terms of the placebo response, the composite endpoint was deliberately chosen as a primary endpoint, as it controls better for placebo response. It's very difficult for a placebo patient to achieve resolution by themselves on fibrosis and all the clinical endpoints of MASH. Therefore, that was why that placebo rate was chosen.

Andrew Obenshain

Really, I'm not going to speculate on what the placebo rate will be after an 18-month trial versus a six-month trial, but certainly it's our expectation that having that composite endpoint does help mitigate any fluctuation in placebo rates.

Speaker 14

Yeah. Okay. Thank you so much.

Operator

We will now go to our last question, and that question comes from the line of Andy Chen from Wolfe Research. Please go ahead. Your line is open.

Jason Zhang

Hi. Thank you so much. This is Jason taking it for Andy, and we just wanted to ask another question about GLP-1. Do you guys think the baseline GLP-1 subgroup is large enough to meaningfully assess whether lanifibranor provides incremental histological benefits on top of the therapy? How would that sensitivity analysis be presented? If you could provide some color on that. Thank you.

Andrew Obenshain

Yeah. First of all, clarification, the GLP-1s drop-ins that were allowed in the trial were not at the MASH dose. They were at a lower dose. There should be no histological impact of the GLP-1 on the GLP-1. I think that in terms of doing a subset analysis, I think that answers the question that we don't anticipate that there should be a histological effect of the GLP-1.

Jason Zhang

Gotcha. Thank you.

Andrew Obenshain

Jason, would you add anything to that?

Jason Campagna

No, I do, Andrew. Andy, a good question. Just referring you back to earlier in the Q&A around the sensitivity analyses and that this question, the form of the question, how is it that other therapeutics that are dropped into a late-stage clinical trial may affect the primary endpoint? This is routinely handled in phase III trials, not only outside, like in atopic dermatitis and use of steroids, but also within MASH. So the sensitivity analyses that we will run are completely routine and standard for a phase III program facing those kinds of questions.

Jason Zhang

Gotcha. Thank you.

Operator

Thank you. There are no further questions at this time, so I will hand the call back to Andrew for closing remarks.

Andrew Obenshain

Yeah, I want to thank everyone for joining today and for the questions. Inventiva is at an inflection point right now. We are very excited to be approaching the top-line results in Q4 this year and the potential to bring a therapy forward for a large patient population with a large unmet need and bring a new therapy option. Thank you, everyone, for your interest, and we will see you, I think the next time we talk will be on the data release. Thank you.

Operator

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

Related articleQuarter not tagged2026-07-30

Correction: Inventiva Announces Preliminary Financial Results for the First Half of 2026¹

GlobeNewswire
Cash and cash equivalents at €166.1 million and €67.8 million in short-term deposits2 as at June 30, 2026 Daix (France), New York City (New York, United States), July 30, 2026 – Update to Press Release Dated July 29, 2026. The Company wishes to correct an error in the press release issued on July 29, 2026. On page 2, the potential proceeds for the Tranche C of the Debt Financing Transaction was mistakenly stated as €20 million. The correct figure is €55 million. All other information in the press release remains unchanged. As a result, the corrected version shall read as follows: Inventiva (Euronext Paris and NASDAQ: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of an oral therapy for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today reported certain preliminary financial results for the first half of 2026, including its cash, cash equivalents and revenues. Preliminary Financial Results As at June 30, 2026, the Company’s cash and cash equivalents amounted to €166.1 million and €67.8 million in short-term deposits2, compared to cash and cash equivalents at €99.3 million and €131.6 million in short-term deposits as at December 31, 2025. Net cash used in operating activities amounted to (€48.7) million for the first half of 2026, compared to (€53.7) million for the same period in 2025. The lower cash consumption mainly reflects the working capital change of €8.8 million between the two periods. This lower cash consumption is partially offset by the increase in operating expenses relating to the continued advancement of the NATiV3 Phase 3 clinical trial and preparation of pre commercial activities. R&D expenses amounted to (€50.1) million in the first half of 2026 compared to (€44.9) for the same period in 2025. Net cash generated from investing activities for the first half of 2026 amounted to €63.9 million, compared to (€24.8) million for the first half of 2025. The increase is mostly due to new short-term deposit subscriptions following the June combined financing operations announced on June 2, 20263. Net cash generated from financing activities for the first half of 2026 amounted to €50.9 million, compared to €104.8 million in the first half of 2025. The net cash generated from financing activities in the first half of 2026 reflects the comprehensive capital structu…Read full document

Cash and cash equivalents at €166.1 million and €67.8 million in short-term deposits2 as at June 30, 2026 Daix (France), New York City (New York, United States), July 30, 2026 – Update to Press Release Dated July 29, 2026. The Company wishes to correct an error in the press release issued on July 29, 2026. On page 2, the potential proceeds for the Tranche C of the Debt Financing Transaction was mistakenly stated as €20 million. The correct figure is €55 million. All other information in the press release remains unchanged. As a result, the corrected version shall read as follows: Inventiva (Euronext Paris and NASDAQ: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of an oral therapy for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today reported certain preliminary financial results for the first half of 2026, including its cash, cash equivalents and revenues. Preliminary Financial Results As at June 30, 2026, the Company’s cash and cash equivalents amounted to €166.1 million and €67.8 million in short-term deposits2, compared to cash and cash equivalents at €99.3 million and €131.6 million in short-term deposits as at December 31, 2025. Net cash used in operating activities amounted to (€48.7) million for the first half of 2026, compared to (€53.7) million for the same period in 2025. The lower cash consumption mainly reflects the working capital change of €8.8 million between the two periods. This lower cash consumption is partially offset by the increase in operating expenses relating to the continued advancement of the NATiV3 Phase 3 clinical trial and preparation of pre commercial activities. R&D expenses amounted to (€50.1) million in the first half of 2026 compared to (€44.9) for the same period in 2025. Net cash generated from investing activities for the first half of 2026 amounted to €63.9 million, compared to (€24.8) million for the first half of 2025. The increase is mostly due to new short-term deposit subscriptions following the June combined financing operations announced on June 2, 20263. Net cash generated from financing activities for the first half of 2026 amounted to €50.9 million, compared to €104.8 million in the first half of 2025. The net cash generated from financing activities in the first half of 2026 reflects the comprehensive capital structure optimization announced on June 2, 2026, including the Equity Offering of €103 million and the Debt Financing Transaction of €75 million4. These cash inflows were partially offset by the repayment in full of the existing EIB loan for an aggregate amount of €62 million, and the repurchase of the Legacy EIB Tranche A Warrants and 700,000 of the Legacy EIB Tranche B Warrants for an aggregate repurchase price of €50 million. For further information regarding these transactions, please refer to the Company’s press releases dated June 2, 2026 and June 12, 2026. The net cash generated from financing activities in the first half of 2025 came from the gross proceeds of €115.6 million (net proceeds of €108.0 million) from the second tranche of the Structured Financing announced in October 20245. Based on the Company’s existing cash and cash equivalents and short-term deposits, together with the net proceeds from the completed Equity Offering, the completed EIB Transactions and the issuance of Tranches A and B under the Debt Financing Transaction6, the Company expects to be able to finance its operations as currently planned until the end of the second quarter of 2027. At the date of this communication, the Company's current cash and cash equivalents are not sufficient to cover operating needs as currently planned for the next 12 months. Based on the Company’s existing cash and cash equivalents and short-term deposits, together with the net proceeds from the completed Equity Offering, the completed EIB Transactions and the issuance of Tranches A and B under the Debt Financing Transaction, and assuming the successful completion of Tranche C of the Debt Financing Transaction for potential proceeds of up to €55.0 million and the exercise in full of the Tranche 3 warrants previously issued by the Company in the Structured Financing4 for potential proceeds of up to €116.0 million, the Company expects to be able to finance its operations as currently planned until the start of the first quarter of 20287. Over the first half of 2026, the Company recorded a positive foreign exchange effect on cash and cash equivalents of €0.7 million, compared with a negative effect of (€0.7) million for the first half of 2025, primarily due to the changes in the EUR/USD exchange rate. Revenues No revenues recorded for the first half of 2026, compared to €4.5 million generated for the same period in 2025. Next financial results publication Financial results for the first half of 2026: Wednesday September 25, 2026 (after U.S. market close) About Inventiva Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of an orally administered small molecule for the treatment of patients with MASH. The Company is currently evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for the treatment of adult patients with MASH, a common and progressive chronic liver disease. Inventiva is a public company listed on compartment B of the regulated market of Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: IVA). https://www.inventivapharma.com Contacts Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These statements include, but are not limited to, preliminary unaudited financial results for Inventiva’s six months ended June 30, 2026, forecasts and estimates with respect to Inventiva’s cash resources and expenses, including expectations and assumptions in connection with Inventiva’s estimated cash runway and estimates with respect to Inventiva’s NATiV3 Phase 3 clinical trial with lanifibranor in patients with MASH, including design, duration, timing, costs, the information, insights and impacts that may be gathered from clinical trials, the potential therapeutic benefits of lanifibranor, potential regulatory submissions, approvals and commercialization, and Inventiva’s pipeline development plans, future activities, expectations, plans, growth and prospects. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “would”, “could”, “might”, “should”, “designed”, “hopefully”, “target”, “potential”, “possible”, “aim”, and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management’s beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva's control. There can be no guarantees with respect to product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, that product candidates will receive the necessary regulatory approvals, or that any of the anticipated milestones by Inventiva or its partners will be reached on their expected timeline, or at all. Future results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates, due to a number of factors, including the completion of financial closing procedures, final adjustments and other developments that may arise that could cause the preliminary financial results for the first half of 2026 to differ from the financial results that will be reflected in Inventiva’s reviewed consolidated financial statements for the first half of 2026, that Inventiva is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception, Inventiva has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, in the absence of which, Inventiva may be required to significantly curtail, delay or discontinue one or more of its research or development programs or be unable to expand its operations or otherwise capitalize on its business opportunities and may be unable to continue as a going concern, Inventiva’s ability to obtain financing and to enter into potential transactions, Inventiva’s future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of lanifibranor, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva’s and its partners’ clinical trials may not support Inventiva’s and its partners’ product candidate claims, Inventiva’s expectations with respect to its clinical trials may prove to be wrong and regulatory authorities may require additional holds and/or amendments to Inventiva’s clinical trials, Inventiva’s expectations with respect to the clinical development plan for lanifibranor for the treatment of MASH may not be realized and may not support the approval of a New Drug Application, Inventiva’s ability to identify additional products or product candidates with significant commercial potential, Inventiva’s expectations with respect to its pipeline prioritization plan and related workforce reduction, including the timing, potential benefits, expenses and consequences relating thereto, Inventiva’s ability to execute on its commercialization, marketing and manufacturing capabilities and strategy, Inventiva’s ability to successfully cooperate with existing partners or enter into new partnerships, and to fulfill its obligations under any agreements entered into in connection with such partnerships, the benefits of its existing and future partnerships on the clinical development, regulatory approvals and, if approved, commercialization of its product candidates, and the achievement of milestones thereunder and the timing thereof, Inventiva and its partners may encounter substantial delays beyond expectations in their clinical trials or fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, the ability of Inventiva and its partners to recruit and retain patients in clinical studies, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva’s and its partners’ control, Inventiva’s product candidates may cause adverse drug reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva’s and its partners’ business, and preclinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by changes in law and regulations, unfavorable conditions in its industry, geopolitical events, such as the conflict between Russia and Ukraine and related sanctions, the conflict in the Middle East and the related risk of a larger conflict, health epidemics, and macroeconomic conditions, including developments in international trade policies, global inflation, financial and credit market fluctuations, tariffs and other trade barriers, political turmoil, and natural catastrophes, uncertain financial markets and disruptions in banking systems. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements. Please refer to the Universal Registration Document for the year ended December 31, 2025 filed with the Autorité des Marchés Financiers on April 8, 2026, and the Annual Report on Form 20-F for the year ended December 31, 2025 filed with the SEC on April 8, 2026 for other risks and uncertainties affecting Inventiva, including those described under the caption "Risk Factors", and in future filings with the SEC. Other risks and uncertainties of which Inventiva is not currently aware may also affect its forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. All information in this press release is as of the date of the release. Except as required by law, Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements. 1 Preliminary, non-audited financial information2 Short-term deposits were included in the category “other current assets” in the IFRS consolidated statement of financial position and were considered by the Company as liquid and easily available.3 Cf press release of June 2, 20264 Capitalized terms used herein and not otherwise defined have the meanings given to them in the Company's press release dated June 2, 2026.5 Cf press release of October 13, 20246 Cf press release of June 2, 2026 (In particular the description of the financial covenants pertaining to the Debt Financing)7 These estimates are based on the Company’s current business plan and exclude any potential milestones payable to or by the Company and any additional expenditures related to the product candidate or resulting from any potential in licensing or acquisition of additional product candidates or technologies, or any associated product development the Company may pursue. The Company may have based these estimates on assumptions that are incorrect, the Company may amend its business plan in the future and the Company may have to use its resources sooner than anticipated. These estimates may be shortened in the event of an increase, in expenditure relating to the development programs beyond the Company's expectations, or if the development program progresses more quickly than expected. There can be no assurance whether, and to what extent, the Tranche 3 warrants will be exercised, if at all. Attachment Inventiva - PR - Preliminary Financial Results H1 2026 - EN - 07 30 2026

Related articleQuarter not tagged2026-07-29

Inventiva Announces Preliminary Financial Results for the First Half of 2026¹

GlobeNewswire
Cash and cash equivalents at €166.1 million and €67.8 million in short-term deposits2 as at June 30, 2026 Daix (France), New York City (New York, United States), July 29, 2026 – Inventiva (Euronext Paris and NASDAQ: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of an oral therapy for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today reported certain preliminary financial results for the first half of 2026, including its cash, cash equivalents and revenues. Preliminary Financial Results As at June 30, 2026, the Company’s cash and cash equivalents amounted to €166.1 million and €67.8 million in short-term deposits2, compared to cash and cash equivalents at €99.3 million and €131.6 million in short-term deposits as at December 31, 2025. Net cash used in operating activities amounted to (€48.7) million for the first half of 2026, compared to (€53.7) million for the same period in 2025. The lower cash consumption mainly reflects the working capital change of €8.8 million between the two periods. This lower cash consumption is partially offset by the increase in operating expenses relating to the continued advancement of the NATiV3 Phase 3 clinical trial and preparation of pre commercial activities. R&D expenses amounted to (€50.1) million in the first half of 2026 compared to (€44.9) for the same period in 2025. Net cash generated from investing activities for the first half of 2026 amounted to €63.9 million, compared to (€24.8) million for the first half of 2025. The increase is mostly due to new short term deposit subscriptions following the June combined financing operations announced on June 2, 20263. Net cash generated from financing activities for the first half of 2026 amounted to €50.9 million, compared to €104.8 million in the first half of 2025. The net cash generated from financing activities in the first half of 2026 reflects the comprehensive capital structure optimization announced on June 2, 2026, including the Equity Offering of €103 million and the Debt Financing Transaction of €75 million4. These cash inflows were partially offset by the repayment in full of the existing EIB loan for an aggregate amount of €62 million, and the repurchase of the Legacy EIB Tranche A Warrants and 700,000 of the Legacy EIB Tranche B Warrants for an aggregate repurchase pric…Read full document

Cash and cash equivalents at €166.1 million and €67.8 million in short-term deposits2 as at June 30, 2026 Daix (France), New York City (New York, United States), July 29, 2026 – Inventiva (Euronext Paris and NASDAQ: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of an oral therapy for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today reported certain preliminary financial results for the first half of 2026, including its cash, cash equivalents and revenues. Preliminary Financial Results As at June 30, 2026, the Company’s cash and cash equivalents amounted to €166.1 million and €67.8 million in short-term deposits2, compared to cash and cash equivalents at €99.3 million and €131.6 million in short-term deposits as at December 31, 2025. Net cash used in operating activities amounted to (€48.7) million for the first half of 2026, compared to (€53.7) million for the same period in 2025. The lower cash consumption mainly reflects the working capital change of €8.8 million between the two periods. This lower cash consumption is partially offset by the increase in operating expenses relating to the continued advancement of the NATiV3 Phase 3 clinical trial and preparation of pre commercial activities. R&D expenses amounted to (€50.1) million in the first half of 2026 compared to (€44.9) for the same period in 2025. Net cash generated from investing activities for the first half of 2026 amounted to €63.9 million, compared to (€24.8) million for the first half of 2025. The increase is mostly due to new short term deposit subscriptions following the June combined financing operations announced on June 2, 20263. Net cash generated from financing activities for the first half of 2026 amounted to €50.9 million, compared to €104.8 million in the first half of 2025. The net cash generated from financing activities in the first half of 2026 reflects the comprehensive capital structure optimization announced on June 2, 2026, including the Equity Offering of €103 million and the Debt Financing Transaction of €75 million4. These cash inflows were partially offset by the repayment in full of the existing EIB loan for an aggregate amount of €62 million, and the repurchase of the Legacy EIB Tranche A Warrants and 700,000 of the Legacy EIB Tranche B Warrants for an aggregate repurchase price of €50 million. For further information regarding these transactions, please refer to the Company’s press releases dated June 2, 2026 and June 12, 2026. The net cash generated from financing activities in the first half of 2025 came from the gross proceeds of €115.6 million (net proceeds of €108.0 million) from the second tranche of the Structured Financing announced in October 20245. Based on the Company’s existing cash and cash equivalents and short-term deposits, together with the net proceeds from the completed Equity Offering, the completed EIB Transactions and the issuance of Tranches A and B under the Debt Financing Transaction6, the Company expects to be able to finance its operations as currently planned until the end of the second quarter of 2027. At the date of this communication, the Company's current cash and cash equivalents are not sufficient to cover operating needs as currently planned for the next 12 months. Based on the Company’s existing cash and cash equivalents and short-term deposits, together with the net proceeds from the completed Equity Offering, the completed EIB Transactions and the issuance of Tranches A and B under the Debt Financing Transaction, and assuming the successful completion of Tranche C of the Debt Financing Transaction for potential proceeds of up to €20.0 million and the exercise in full of the Tranche 3 warrants previously issued by the Company in the Structured Financing4 for potential proceeds of up to €116.0 million, the Company expects to be able to finance its operations as currently planned until the start of the first quarter of 20287. Over the first half of 2026, the Company recorded a positive foreign exchange effect on cash and cash equivalents of €0.7 million, compared with a negative effect of (€0.7) million for the first half of 2025, primarily due to the changes in the EUR/USD exchange rate. Revenues No revenues recorded for the first half of 2026, compared to €4.5 million generated for the same period in 2025. Next financial results publication Financial results for the first half of 2026: Wednesday September 25, 2026 (after U.S. market close) About Inventiva Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of an orally administered small molecule for the treatment of patients with MASH. The Company is currently evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for the treatment of adult patients with MASH, a common and progressive chronic liver disease. Inventiva is a public company listed on compartment B of the regulated market of Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: IVA). https://www.inventivapharma.com Contacts Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These statements include, but are not limited to, preliminary unaudited financial results for Inventiva’s six months ended June 30, 2026, forecasts and estimates with respect to Inventiva’s cash resources and expenses, including expectations and assumptions in connection with Inventiva’s estimated cash runway and estimates with respect to Inventiva’s NATiV3 Phase 3 clinical trial with lanifibranor in patients with MASH, including design, duration, timing, costs, the information, insights and impacts that may be gathered from clinical trials, the potential therapeutic benefits of lanifibranor, potential regulatory submissions, approvals and commercialization, and Inventiva’s pipeline development plans, future activities, expectations, plans, growth and prospects. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “would”, “could”, “might”, “should”, “designed”, “hopefully”, “target”, “potential”, “possible”, “aim”, and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management’s beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva's control. There can be no guarantees with respect to product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, that product candidates will receive the necessary regulatory approvals, or that any of the anticipated milestones by Inventiva or its partners will be reached on their expected timeline, or at all. Future results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates, due to a number of factors, including the completion of financial closing procedures, final adjustments and other developments that may arise that could cause the preliminary financial results for the first half of 2026 to differ from the financial results that will be reflected in Inventiva’s reviewed consolidated financial statements for the first half of 2026, that Inventiva is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception, Inventiva has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, in the absence of which, Inventiva may be required to significantly curtail, delay or discontinue one or more of its research or development programs or be unable to expand its operations or otherwise capitalize on its business opportunities and may be unable to continue as a going concern, Inventiva’s ability to obtain financing and to enter into potential transactions, Inventiva’s future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of lanifibranor, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva’s and its partners’ clinical trials may not support Inventiva’s and its partners’ product candidate claims, Inventiva’s expectations with respect to its clinical trials may prove to be wrong and regulatory authorities may require additional holds and/or amendments to Inventiva’s clinical trials, Inventiva’s expectations with respect to the clinical development plan for lanifibranor for the treatment of MASH may not be realized and may not support the approval of a New Drug Application, Inventiva’s ability to identify additional products or product candidates with significant commercial potential, Inventiva’s expectations with respect to its pipeline prioritization plan and related workforce reduction, including the timing, potential benefits, expenses and consequences relating thereto, Inventiva’s ability to execute on its commercialization, marketing and manufacturing capabilities and strategy, Inventiva’s ability to successfully cooperate with existing partners or enter into new partnerships, and to fulfill its obligations under any agreements entered into in connection with such partnerships, the benefits of its existing and future partnerships on the clinical development, regulatory approvals and, if approved, commercialization of its product candidates, and the achievement of milestones thereunder and the timing thereof, Inventiva and its partners may encounter substantial delays beyond expectations in their clinical trials or fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, the ability of Inventiva and its partners to recruit and retain patients in clinical studies, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva’s and its partners’ control, Inventiva’s product candidates may cause adverse drug reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva’s and its partners’ business, and preclinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by changes in law and regulations, unfavorable conditions in its industry, geopolitical events, such as the conflict between Russia and Ukraine and related sanctions, the conflict in the Middle East and the related risk of a larger conflict, health epidemics, and macroeconomic conditions, including developments in international trade policies, global inflation, financial and credit market fluctuations, tariffs and other trade barriers, political turmoil, and natural catastrophes, uncertain financial markets and disruptions in banking systems. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements. Please refer to the Universal Registration Document for the year ended December 31, 2025 filed with the Autorité des Marchés Financiers on April 8, 2026, and the Annual Report on Form 20-F for the year ended December 31, 2025 filed with the SEC on April 8, 2026 for other risks and uncertainties affecting Inventiva, including those described under the caption "Risk Factors", and in future filings with the SEC. Other risks and uncertainties of which Inventiva is not currently aware may also affect its forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. All information in this press release is as of the date of the release. Except as required by law, Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements. 1 Preliminary, non-audited financial information2 Short-term deposits were included in the category “other current assets” in the IFRS consolidated statement of financial position and were considered by the Company as liquid and easily available.3 Cf press release of June 2, 20264 Capitalized terms used herein and not otherwise defined have the meanings given to them in the Company's press release dated June 2, 2026.5 Cf press release of October 13, 20246 Cf press release of June 2, 2026 (In particular the description of the financial covenants pertaining to the Debt Financing)7 These estimates are based on the Company’s current business plan and exclude any potential milestones payable to or by the Company and any additional expenditures related to the product candidate or resulting from any potential in licensing or acquisition of additional product candidates or technologies, or any associated product development the Company may pursue. The Company may have based these estimates on assumptions that are incorrect, the Company may amend its business plan in the future and the Company may have to use its resources sooner than anticipated. These estimates may be shortened in the event of an increase, in expenditure relating to the development programs beyond the Company's expectations, or if the development program progresses more quickly than expected. There can be no assurance whether, and to what extent, the Tranche 3 warrants will be exercised, if at all. Attachment Inventiva - PR - Preliminary Financial Results H1 2026 - EN - 07 29 2026

Related articleQuarter not tagged2026-07-02

Results of the Votes of the Combined Shareholders’ General Meeting of June 30, 2026

GlobeNewswire
Daix (France), New York City (New York, United States), July 2, 2026 – Inventiva (Euronext Paris and NASDAQ: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of an oral therapy for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today announced the results of the votes of its Combined Shareholders’ Meeting. The Combined Shareholders' Meeting was held on Tuesday June 30, 2026, at 2 p.m. at Hôtel Villa M, 24-30 Bd Pasteur, 75015 Paris (France), under the chairmanship of Mr. Andrew Obenshain, Chief Executive Officer of Inventiva. Mr. Andrew Obenshain proceeded to the usual formalities of the opening of the meeting, in particular to the constitution of the Bureau by appointing Mrs Susan Coles and Mr. Jean Volatier, as tellers, as well as Mr. Abel Colomb, as secretary of the general meeting. All the resolutions submitted to vote have been adopted by the shareholders, with the exception of the 31st resolution, which had been the subject of a negative recommendation by the Board of Directors. The 31st resolution would have empowered the Board of Directors to decide on share capital increases reserved for members of a company savings plan to be set up by the Company. Pursuant to Article R. 22-10-14 IV. of the French Commercial Code, the Combined Shareholders’ Meeting approved, without modification, the compensation policy for corporate officers as presented in the 2025 Universal Registration Document (section 3.5.1, pages 134 et seq.) and, with respect specifically to the chairman of the board of directors, in the notice of meeting (brochure de convocation) for the Combined General Meeting, made available on the Company’s website under the “General Meetings” section. The results of the vote are presented below: Total number of shares composing the share capital: 236 280 202 Total number of shares with voting rights: 236 280 202 VOTE RESULTS: Ordinary Resolutions VOTE RESULTS: Extraordinary Resolutions About Inventiva Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of an orally administered small molecule for the treatment of patients with MASH. The Company is currently evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for the treatment of adult patients with MASH, a common and progressiv…Read full document

Daix (France), New York City (New York, United States), July 2, 2026 – Inventiva (Euronext Paris and NASDAQ: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of an oral therapy for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today announced the results of the votes of its Combined Shareholders’ Meeting. The Combined Shareholders' Meeting was held on Tuesday June 30, 2026, at 2 p.m. at Hôtel Villa M, 24-30 Bd Pasteur, 75015 Paris (France), under the chairmanship of Mr. Andrew Obenshain, Chief Executive Officer of Inventiva. Mr. Andrew Obenshain proceeded to the usual formalities of the opening of the meeting, in particular to the constitution of the Bureau by appointing Mrs Susan Coles and Mr. Jean Volatier, as tellers, as well as Mr. Abel Colomb, as secretary of the general meeting. All the resolutions submitted to vote have been adopted by the shareholders, with the exception of the 31st resolution, which had been the subject of a negative recommendation by the Board of Directors. The 31st resolution would have empowered the Board of Directors to decide on share capital increases reserved for members of a company savings plan to be set up by the Company. Pursuant to Article R. 22-10-14 IV. of the French Commercial Code, the Combined Shareholders’ Meeting approved, without modification, the compensation policy for corporate officers as presented in the 2025 Universal Registration Document (section 3.5.1, pages 134 et seq.) and, with respect specifically to the chairman of the board of directors, in the notice of meeting (brochure de convocation) for the Combined General Meeting, made available on the Company’s website under the “General Meetings” section. The results of the vote are presented below: Total number of shares composing the share capital: 236 280 202 Total number of shares with voting rights: 236 280 202 VOTE RESULTS: Ordinary Resolutions VOTE RESULTS: Extraordinary Resolutions About Inventiva Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of an orally administered small molecule for the treatment of patients with MASH. The Company is currently evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for the treatment of adult patients with MASH, a common and progressive chronic liver disease. Inventiva is a public company listed on compartment B of the regulated market of Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: IVA). https://www.inventivapharma.com Contacts Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included in this press release are forward-looking statements. These statements include, but are not limited to, forecasts and estimates regarding Inventiva's cash resources and expenses, forecasts and estimates with respect to Inventiva’s NATiV3 Phase 3 clinical trial with lanifibranor in patients with MASH, including the quality of trial results, design, duration, timing, costs, and funding, timing of clinical trial data releases and publications, the information, insights and impacts that may be gathered from clinical trials, the potential therapeutic benefits of lanifibranor, potential regulatory submissions, approvals and commercialization, Inventiva’s pipeline and development plans, and Inventiva's future activities, expectations, plans, growth and prospects. Some of these statements, forecasts, and estimates may be identified by the use of words such as, without limitation, “believe,” “anticipate,” “expect,” “intend,” “plan,” “seek,” “estimate,” “may,” “will,” “could,” “should,” “designed,” “hope,” “target,” “potential,” “opportunity,” “possible,” “aim,” and “continue” and other similar expressions. These statements are not historical facts, but rather statements of future expectations and other forward-looking statements based on management's beliefs. These statements reflect the opinions and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance, or events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend on factors beyond Inventiva's control. There can be no guarantee, with respect to product candidates, that clinical trial results will be available on schedule, that future clinical trials will be initiated as planned, that product candidates will receive the necessary regulatory approvals, or that the milestones planned by Inventiva or its partners will be achieved on schedule, or even at all. Future results may differ materially from the anticipated future results, performance, or achievements expressed or implied by these statements, forecasts, and estimates due to a number of factors, including the fact that interim data or data from any interim analysis of ongoing clinical trials do not predict the future results of clinical trials, the fact that the DMC's recommendation does not prejudge any eventual marketing authorization, that Inventiva cannot provide assurance on the impacts of the Suspected Unexpected Serious Adverse Reaction (SUSAR) on recruitment or the final impact on the results or timing of the NATiV3 trial or related regulatory issues, Inventiva is a clinical-stage company with no approved products and no historical revenue, Inventiva has incurred significant losses since its inception, Inventiva has never generated revenue from product sales, Inventiva will need additional capital to fund its operations, without which Inventiva may be required to significantly reduce its activities, delay or discontinue one or more of its research or development programs, expand its activities or capitalize on its business opportunities, and may not be able to continue as a going concern. Inventiva's ability to obtain financing and complete potential transactions on a timely basis, as well as whether, when, and to what extent dilutive instruments may be exercised and by which holders, Inventiva's future success depends on the successful clinical development, regulatory approvals, and subsequent commercialization of lanifibranor, preclinical studies or previous clinical trials are not necessarily predictive of future results, and the results of Inventiva's and its partners' clinical trials may not support Inventiva's and its partners' claims regarding product candidates, Inventiva's expectations regarding its clinical trials may prove to be incorrect, and regulatory authorities may require additional stops and/or modifications to Inventiva's clinical trials. Inventiva's expectations regarding the clinical development plan for lanifibranor for the treatment of MASH may not be realized and may not support the approval of a New Drug Application, Inventiva's ability to implement its commercialization, marketing, and manufacturing capabilities and strategy, Inventiva's ability to successfully cooperate with its existing partners or enter into new partnerships, and to fulfil its obligations under any agreements entered into in connection with such partnerships, the benefits of its current and future partnerships on the clinical development, regulatory approvals, and, if applicable, commercialization of its product candidates, as well as the achievement of milestones and timelines anticipated in connection with such partnerships, Inventiva and its partners may encounter substantial delays beyond expectations in their clinical trials or fail to demonstrate safety and efficacy to the satisfaction of the applicable regulatory authorities, the ability of Inventiva and its partners to recruit and retain patients in clinical studies, the recruitment and retention of patients in clinical trials is a costly and time-consuming process that could be made more difficult or impossible by multiple factors beyond the control of Inventiva and its partners, Inventiva's product candidates may cause adverse reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces significant competition, and Inventiva's activities, preclinical studies, and clinical development programs, as well as timelines, Inventiva's financial condition and results of operations could be materially and adversely affected by changes in laws and regulations, adverse conditions in its industry, geopolitical events, such as the conflict between Russia and Ukraine and the resulting sanctions, the conflict in the Middle East and the related risk of a wider conflict and ongoing conflicts, epidemics, and macroeconomic conditions, including changes in international trade policies, global inflation, fluctuations in financial and credit markets, customs duties and other trade barriers, political unrest and natural disasters, uncertain financial markets, and disruptions in banking systems. In light of these risks and uncertainties, no representation is made as to the accuracy or completeness of these forward-looking statements, forecasts, and estimates. Furthermore, forward-looking statements, forecasts, and estimates are only valid as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Veuillez vous référer au Document d'Enregistrement Universel pour l'exercice clos le 31 décembre 2025 déposé auprès de l'Autorité des Marchés Financiers le 8 avril 2026, au Rapport Annuel sur le Formulaire 20-F pour l'exercice clos le 31 décembre 2025 déposé auprès de la Securities and Exchange Commission (la « SEC ») le 8 avril 2026 pour d'autres risques et incertitudes affectant Inventiva, y compris ceux susceptibles de mettre en cause la continuité d'exploitation, et ceux décrits sous la rubrique « Facteurs de risques », et dans les futurs dépôts auprès de la SEC. D'autres risques et incertitudes dont Inventiva n'est pas actuellement consciente peuvent également affecter ses déclarations prospectives et peuvent faire en sorte que les résultats réels et le calendrier des événements diffèrent matériellement de ceux anticipés. Toutes les informations contenues dans ce communiqué de presse sont à jour à la date du communiqué. Sauf obligation légale, Inventiva n'a ni l'intention ni l'obligation de mettre à jour ou de réviser les déclarations prospectives mentionnées ci-dessus. Par conséquent, Inventiva n'accepte aucune responsabilité pour les conséquences découlant de l'utilisation de l'une des déclarations susmentionnées. Attachment Inventiva - EN - Results of the votes of the shareholder meeting - PR - 06 30 2026

Related articleQuarter not tagged2026-05-26

Inventiva Reports 2026 First Quarter Financial Information¹

GlobeNewswire
Cash and cash equivalents at €75.0 million, and €121.5 million in short-term deposits2 Daix (France), New York City (New York, United States), May 26, 2026 – Inventiva (Euronext Paris and NASDAQ: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today reported its financial information for the first quarter of 2026, including its cash, cash equivalents and revenues. Key Financial Results Cash, Cash Equivalents and Deposits As of March 31, 2026, the Company's cash and cash equivalents amounted to €75.0 million and its short-term deposits2 to €121.5 million, compared to cash and cash equivalents of €99.3 million and short-term deposits of €131.6 million as of December 31, 2025. The net cash used was mainly the result of the Company’s planned operating activities related to its lanifibranor development program. Considering its current cost structure and projected expenses, the Company estimates that its cash, cash equivalents, and short-term deposits should enable it to finance its operations until the middle of the first quarter of 20273. If the Tranche 3 warrants issued in the structured financing announced by the Company in October 2024 (the “Structured Financing”) are exercised in full for proceeds of up to €116.0 million, the Company estimates that such potential additional proceeds would enable it to finance its activities until the middle of the third quarter of 20273. There is no guarantee that the Tranche 3 warrants will be exercised in full, if at all. Revenues The Company did not recognize revenues for the first quarter of 2026, in line with the first quarter of 2025. Anticipated Potential Key Milestones Topline results of NATiV3 – expected in the fourth quarter of 2026 Upcoming Conference Participation EASL Congress, Barcelona, May 27-30 2026 Jefferies Global Healthcare Conference, New York, June 2-4, 2026 Portzamparc BNP Paribas group mid & small caps conference 2026, Paris, June 25, 2026 Next Financial Results Publication Revenues and cash and cash equivalents for the first half of 2026: Wednesday, July 29, 2026 (after U.S. market close) About Inventiva Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of an orally administered small molecule for the…Read full document

Cash and cash equivalents at €75.0 million, and €121.5 million in short-term deposits2 Daix (France), New York City (New York, United States), May 26, 2026 – Inventiva (Euronext Paris and NASDAQ: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today reported its financial information for the first quarter of 2026, including its cash, cash equivalents and revenues. Key Financial Results Cash, Cash Equivalents and Deposits As of March 31, 2026, the Company's cash and cash equivalents amounted to €75.0 million and its short-term deposits2 to €121.5 million, compared to cash and cash equivalents of €99.3 million and short-term deposits of €131.6 million as of December 31, 2025. The net cash used was mainly the result of the Company’s planned operating activities related to its lanifibranor development program. Considering its current cost structure and projected expenses, the Company estimates that its cash, cash equivalents, and short-term deposits should enable it to finance its operations until the middle of the first quarter of 20273. If the Tranche 3 warrants issued in the structured financing announced by the Company in October 2024 (the “Structured Financing”) are exercised in full for proceeds of up to €116.0 million, the Company estimates that such potential additional proceeds would enable it to finance its activities until the middle of the third quarter of 20273. There is no guarantee that the Tranche 3 warrants will be exercised in full, if at all. Revenues The Company did not recognize revenues for the first quarter of 2026, in line with the first quarter of 2025. Anticipated Potential Key Milestones Topline results of NATiV3 – expected in the fourth quarter of 2026 Upcoming Conference Participation EASL Congress, Barcelona, May 27-30 2026 Jefferies Global Healthcare Conference, New York, June 2-4, 2026 Portzamparc BNP Paribas group mid & small caps conference 2026, Paris, June 25, 2026 Next Financial Results Publication Revenues and cash and cash equivalents for the first half of 2026: Wednesday, July 29, 2026 (after U.S. market close) About Inventiva Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of an orally administered small molecule for the treatment of patients with MASH. The Company is currently evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for the treatment of adult patients with MASH, a common and progressive chronic liver disease. Inventiva is a public company listed on compartment B of the regulated market of Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: IVA). https://www.inventivapharma.com Contacts Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included in this press release are forward-looking statements. These statements include, but are not limited to, unaudited financial results for Inventiva’s three months ended March 31, 2026, forecasts and estimates regarding Inventiva's cash resources and expenses, including expectations with respect to EIB mattersand assumptions in connection with Inventiva’s estimated cash runway, the potential exercise by investors of warrants and pre-funded warrants, including warrants and pre-funded warrants issued in connection with the Structured Financing, potential milestone and royalty payments the Company may receive under its agreement with Biossil with respect to odiparcil, including the timing thereof, forecasts and estimates with respect to Inventiva’s NATiV3 Phase 3 clinical trial with lanifibranor in patients with MASH, including the quality of trial results, design, duration, timing, costs, and funding,timing of clinical trial data releases and publications, the information, insights and impacts that may be gathered from clinical trials, the potential therapeutic benefits of lanifibranor, potential regulatory submissions, approvals and commercialization, Inventiva’s pipeline and development plans, and Inventiva's future activities, expectations, plans, growth and prospects. Some of these statements, forecasts, and estimates may be identified by the use of words such as, without limitation, “believe,” “anticipate,” “expect,” “intend,” “plan,” “seek,” “estimate,” “may,” “will,” “could,” “should,” “designed,” “hope,” “target,” “potential,” “opportunity,” “possible,” “aim,” and “continue” and other similar expressions. These statements are not historical facts, but rather statements of future expectations and other forward-looking statements based on management's beliefs. These statements reflect the opinions and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance, or events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend on factors beyond Inventiva's control. There can be no guarantee, with respect to product candidates, that clinical trial results will be available on schedule, that future clinical trials will be initiated as planned, that product candidates will receive the necessary regulatory approvals, or that the milestones planned by Inventiva or its partners will be achieved on schedule, or even at all. Future results may differ materially from the anticipated future results, performance, or achievements expressed or implied by these statements, forecasts, and estimates due to a number of factors, including the fact that interim data or data from any interim analysis of ongoing clinical trials do not predict the future results of clinical trials, the fact that the DMC's recommendation does not prejudge any eventual marketing authorization, that Inventiva cannot provide assurance on the impacts of the Suspected Unexpected Serious Adverse Reaction (SUSAR) on recruitment or the final impact on the results or timing of the NATiV3 trial or related regulatory issues, Inventiva is a clinical-stage company with no approved products and no historical revenue, Inventiva has incurred significant losses since its inception, Inventiva has never generated revenue from product sales, Inventiva will need additional capital to fund its operations, without which Inventiva may be required to significantly reduce its activities, delay or discontinue one or more of its research or development programs, expand its activities or capitalize on its business opportunities, and may not be able to continue as a going concern. Inventiva's ability to obtain financing and complete potential transactions on a timely basis, as well as whether, when, and to what extent dilutive instruments may be exercised and by which holders, Inventiva's future success depends on the successful clinical development, regulatory approvals, and subsequent commercialization of lanifibranor, preclinical studies or previous clinical trials are not necessarily predictive of future results, and the results of Inventiva's and its partners' clinical trials may not support Inventiva's and its partners' claims regarding product candidates, Inventiva's expectations regarding its clinical trials may prove to be incorrect, and regulatory authorities may require additional stops and/or modifications to Inventiva's clinical trials. Inventiva's expectations regarding the clinical development plan for lanifibranor for the treatment of MASH may not be realized and may not support the approval of a New Drug Application, Inventiva's ability to implement its commercialization, marketing, and manufacturing capabilities and strategy, Inventiva's ability to successfully cooperate with its existing partners or enter into new partnerships, and to fulfil its obligations under any agreements entered into in connection with such partnerships, the benefits of its current and future partnerships on the clinical development, regulatory approvals, and, if applicable, commercialization of its product candidates, as well as the achievement of milestones and timelines anticipated in connection with such partnerships, Inventiva and its partners may encounter substantial delays beyond expectations in their clinical trials or fail to demonstrate safety and efficacy to the satisfaction of the applicable regulatory authorities, the ability of Inventiva and its partners to recruit and retain patients in clinical studies, the recruitment and retention of patients in clinical trials is a costly and time-consuming process that could be made more difficult or impossible by multiple factors beyond the control of Inventiva and its partners, Inventiva's product candidates may cause adverse reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces significant competition, and Inventiva's activities, preclinical studies, and clinical development programs, as well as timelines, Inventiva's financial condition and results of operations could be materially and adversely affected by changes in laws and regulations, adverse conditions in its industry, geopolitical events, such as the conflict between Russia and Ukraine and the resulting sanctions, the conflict in the Middle East and the related risk of a wider conflict and ongoing conflicts, epidemics, and macroeconomic conditions, including changes in international trade policies, global inflation, fluctuations in financial and credit markets, customs duties and other trade barriers, political unrest and natural disasters, uncertain financial markets, and disruptions in banking systems. In light of these risks and uncertainties, no representation is made as to the accuracy or completeness of these forward-looking statements, forecasts, and estimates. Furthermore, forward-looking statements, forecasts, and estimates are only valid as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Please refer to the Universal Registration Document for the fiscal year ended December 31, 20242025, filed with the Autorité des Marchés Financiers on April 158, 2025, the semi-annual financial report as of June 30, 2025, published on September 29, 20252026, and the Annual Report on Form 20-F for the fiscal year ended December 31, 20242025 filed with the Securities and Exchange Commission (the “SEC”) on April 15, 2025 and the Half-Year Report for the six months ended June 30, 2025 on Form 6-K filed with the SEC on October 15, 20258, 2026 for other risks and uncertainties affecting Inventiva, including those described under the heading “Risk Factors,” and in future filings with the SEC. Other risks and uncertainties that Inventiva is not currently aware of may also affect its forward-looking statements and may cause actual results and timing of events to differ materially from those anticipated. All information contained in this press release is current as of the date of this release. Except as required by law, Inventiva has no intention or obligation to update or revise the forward-looking statements mentioned above. Therefore, Inventiva accepts no responsibility for the consequences arising from the use of any of the above statements. Non-audited financial information. Short-term deposits were classified as “other current assets” in the consolidated statement of financial position in accordance with IFRS and were considered by the Company to be liquid and readily available. This estimate is based on the Company's current business plan, but excludes potential milestone payments to be paid or received by the Company, any potential proceeds from the exercise of Tranche 3 warrants issued as part of the Structured Financing (unless specifically stated), as well as any additional expenses related to other product candidates or resulting from the licensing or acquisition of additional product candidates or technologies, or any related developments that the Company may pursue. The Company may have based these estimates on assumptions that are incorrect or may amend its business plan in the future, and the Company may end up using its resources sooner than anticipated. These estimates may be shortened in the event of an increase, beyond the Company's expectations, in expenditure relating to the development program, or if the development program of the Company progresses more quickly than expected. Attachment Inventiva - PR - Q1 2026 Financial Report - EN - 05 26 2026

Related articleQuarter not tagged2026-04-02

Inventiva SA (IVA) (Q4 2025) Earnings Call Highlights: Strategic Milestones and Financial ...

GuruFocus.com
This article first appeared on GuruFocus. Cash and Cash Equivalents: EUR230.9 million as of December 31, 2025. Net Proceeds from Financing: EUR108 million from structured financing in May 2025; EUR139.4 million from U.S.-registered public offering in November 2025. Cash Runway: Estimated to extend to mid-Q1 2027, potentially to mid-Q3 2027 with full exercise of Tranche 3 warrants. R&D Expenses: EUR87 million for the full year 2025. Marketing and Business Development Expenses: EUR5 million for pre-commercial investment. G&A Expenses: EUR47.9 million, including EUR20.3 million of non-cash share-based compensation. Warning! GuruFocus has detected 7 Warning Signs with IVA. Is IVA fairly valued? Test your thesis with our free DCF calculator. Release Date: March 31, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Inventiva SA (NASDAQ:IVA) completed enrollment for its global Phase III clinical trial, NATIV-3, marking a significant operational milestone. The company is well-funded, with EUR230.9 million in cash equivalents and short-term deposits, ensuring financial stability beyond the anticipated NATIV-3 readout. Inventiva SA (NASDAQ:IVA) strategically sold global rights to OdaParcel, potentially receiving up to $90 million in milestone payments and royalties, allowing focus on lanifibranor. Lanifibranor has received both breakthrough therapy and fast-track designations from the FDA, highlighting its potential as a treatment for MASH. The leadership team has been strengthened with key appointments to align with the company's strategic focus on lanifibranor and MASH. The top-line readout for the NATIV-3 trial has been delayed to Q4 2026, which may impact investor expectations. Despite improvements, only around 10% of the estimated 18 million people in the US with MASH have been diagnosed, indicating a significant gap in market penetration. The company faces competition from Madrigal, which has seen strong market uptake in the US, posing a challenge for lanifibranor's market entry. There are concerns about weight gain associated with lanifibranor, which could affect its tolerability and acceptance among patients. The company is reliant on the success of the NATIV-3 trial for future funding, as the third tranche of financing is contingent on positive trial results. Q: Can you update us on the trial's dropout r…Read full document

This article first appeared on GuruFocus. Cash and Cash Equivalents: EUR230.9 million as of December 31, 2025. Net Proceeds from Financing: EUR108 million from structured financing in May 2025; EUR139.4 million from U.S.-registered public offering in November 2025. Cash Runway: Estimated to extend to mid-Q1 2027, potentially to mid-Q3 2027 with full exercise of Tranche 3 warrants. R&D Expenses: EUR87 million for the full year 2025. Marketing and Business Development Expenses: EUR5 million for pre-commercial investment. G&A Expenses: EUR47.9 million, including EUR20.3 million of non-cash share-based compensation. Warning! GuruFocus has detected 7 Warning Signs with IVA. Is IVA fairly valued? Test your thesis with our free DCF calculator. Release Date: March 31, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Inventiva SA (NASDAQ:IVA) completed enrollment for its global Phase III clinical trial, NATIV-3, marking a significant operational milestone. The company is well-funded, with EUR230.9 million in cash equivalents and short-term deposits, ensuring financial stability beyond the anticipated NATIV-3 readout. Inventiva SA (NASDAQ:IVA) strategically sold global rights to OdaParcel, potentially receiving up to $90 million in milestone payments and royalties, allowing focus on lanifibranor. Lanifibranor has received both breakthrough therapy and fast-track designations from the FDA, highlighting its potential as a treatment for MASH. The leadership team has been strengthened with key appointments to align with the company's strategic focus on lanifibranor and MASH. The top-line readout for the NATIV-3 trial has been delayed to Q4 2026, which may impact investor expectations. Despite improvements, only around 10% of the estimated 18 million people in the US with MASH have been diagnosed, indicating a significant gap in market penetration. The company faces competition from Madrigal, which has seen strong market uptake in the US, posing a challenge for lanifibranor's market entry. There are concerns about weight gain associated with lanifibranor, which could affect its tolerability and acceptance among patients. The company is reliant on the success of the NATIV-3 trial for future funding, as the third tranche of financing is contingent on positive trial results. Q: Can you update us on the trial's dropout rate and the performance of the 800 vs. 1,200-milligram dose in terms of weight gain and fibrosis? Also, how do you view the opportunity to compete with Madrigal? A: The dropout rate is below 30%, ensuring the trial is well-powered. The 800-milligram dose may catch up to the 1,200-milligram dose over time, with potential differences in tolerability. We believe an 18% fibrosis improvement would position lanifibranor well in the market, especially for F3 diabetic patients. (Andrew Obenshain, CEO; Jason Campagna, CMO) Q: What quality control measures are in place for analyzing biopsy samples in the NATIV-3 trial? A: Quality control involves ensuring proper biopsy procedures, assessing the quality of biopsy samples, and maintaining consistency in slide preparation and reading. Our experienced team is focused on maintaining high standards throughout the process. (Jason Campagna, CMO) Q: What is the effect size for the primary endpoint in NATIV-3, and how does it compare to placebo response? A: We are powered to over 90% for the primary endpoint, with a smaller effect size than seen in Phase II. The composite endpoint is less prone to placebo response, which was 7% in Phase II. We expect a low placebo response in NATIV-3 as well. (Jason Campagna, CMO) Q: How do you view the F3 diabetic population in terms of market opportunity and diagnosis rates? A: The F3 diabetic population is significant, with about 375,000 patients under treated care. Diagnosis rates are improving, and this segment is growing proportionately with the overall market. (Andrew Obenshain, CEO) Q: Can you discuss the potential impact of background GLP-1 use on lanifibranor's effect size and the use of the AIMMASH tool for histological assessments? A: Background GLP-1 use is not expected to significantly impact treatment response, as patients entering the trial have active MASH. The AIMMASH tool is interesting but not anticipated for use in NATIV-3; it may be considered for future trials. (Jason Campagna, CMO) For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Related articleQuarter not tagged2026-03-31

Inventiva reports 2025 full year results and provides a business update

GlobeNewswire
Revenues of €4.5 million for the full year of 2025 Cash and cash equivalents at €99.3 million, and €131.6 million in short-term deposits1 as at December 31, 2025 Completed a U.S. registered public offering for gross proceeds of approximately $172.5 million (€149 million2) Cash runway expected until the middle of the first quarter of 20273 Completed the sale of odiparcil with potential milestone payments of up to $90 million and potential royalties on future net sales, if approved Topline results of NATiV3 Phase 3 clinical trial expected for the fourth quarter of 2026 The Company will host a conference call on March 31, 2026, at 8 a.m. EDT / 2 p.m. CEST Daix (France), New York City (New York, United States), March 30, 2026 – Inventiva (Euronext Paris and NASDAQ: IVA) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today reported its financial results for the full year ended December 31, 2025 and also provided a business update. Andrew Obenshain, CEO of Inventiva, stated: “Inventiva closes the 2025 financial year with the resources expected to fund our operations through the anticipated top-line readout of NATiV3 later this year. In alignment with the careful sequencing of our clinical and operational milestones, we are refining our expected data readout to the fourth quarter of 2026. Our regulatory and commercial infrastructure is advancing in lockstep, to position us to act with speed and conviction once we have the trial data. Lanifibranor has the potential to deliver transformative outcomes for patients with MASH and to generate enduring value for the physicians who treat them and the shareholders who have placed their trust in us. We believe the foundation is sound and the path is clear. And we are fully prepared to deliver.” Key financial results for the full year of 2025 As of December 31, 2025, the Company's cash and cash equivalents amounted to €99.3 million and its short-term deposits1 to €131.6 million, compared to cash and cash equivalents of €96.6 million as of December 31, 2024. Net cash used in operating activities amounted to (€104.9) million in 2025, compared to (€85.9) million in 2024, representing an increase of 22%. R&D expenses, mainly related to the development of lanifibranor in MASH, amounted to €87.0…Read full document

Revenues of €4.5 million for the full year of 2025 Cash and cash equivalents at €99.3 million, and €131.6 million in short-term deposits1 as at December 31, 2025 Completed a U.S. registered public offering for gross proceeds of approximately $172.5 million (€149 million2) Cash runway expected until the middle of the first quarter of 20273 Completed the sale of odiparcil with potential milestone payments of up to $90 million and potential royalties on future net sales, if approved Topline results of NATiV3 Phase 3 clinical trial expected for the fourth quarter of 2026 The Company will host a conference call on March 31, 2026, at 8 a.m. EDT / 2 p.m. CEST Daix (France), New York City (New York, United States), March 30, 2026 – Inventiva (Euronext Paris and NASDAQ: IVA) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today reported its financial results for the full year ended December 31, 2025 and also provided a business update. Andrew Obenshain, CEO of Inventiva, stated: “Inventiva closes the 2025 financial year with the resources expected to fund our operations through the anticipated top-line readout of NATiV3 later this year. In alignment with the careful sequencing of our clinical and operational milestones, we are refining our expected data readout to the fourth quarter of 2026. Our regulatory and commercial infrastructure is advancing in lockstep, to position us to act with speed and conviction once we have the trial data. Lanifibranor has the potential to deliver transformative outcomes for patients with MASH and to generate enduring value for the physicians who treat them and the shareholders who have placed their trust in us. We believe the foundation is sound and the path is clear. And we are fully prepared to deliver.” Key financial results for the full year of 2025 As of December 31, 2025, the Company's cash and cash equivalents amounted to €99.3 million and its short-term deposits1 to €131.6 million, compared to cash and cash equivalents of €96.6 million as of December 31, 2024. Net cash used in operating activities amounted to (€104.9) million in 2025, compared to (€85.9) million in 2024, representing an increase of 22%. R&D expenses, mainly related to the development of lanifibranor in MASH, amounted to €87.0 million in 2025, down by 4% from €90.9 million in 2024. The increase in net cash used in operating activities was mainly related to the net cash impact of the strategic pipeline prioritization plan for the Company's activities implemented in 2025, lower revenues under the licensing agreement with Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (“CTTQ”), and an increase in general and administrative expenses. Net cash used in investing activities amounted to (€133.2) million in 2025, mainly related to the subscription of new short-term deposits during the period, compared with €8.7 million generated in 2024. Net cash generated by financing activities amounted to €241.3 million in 2025, compared to €145.6 million in 2024. This positive cash flow was mainly due to the receipt of (i) gross proceeds of €115.6 million (net proceeds of €108.0 million) from the second tranche in May 2025 of the structured financing announced by the Company in October 2024 (the “Structured Financing”), and (ii) gross proceeds of $172.5 million (net proceeds of €139.4 million) from the public offering in the United States in November 2025. In 2025, the Company recorded a negative exchange rate effect on cash and cash equivalents of (€0.5) million, compared to a positive effect of €1.2 million in 2024, due to changes in the EUR/USD exchange rate. Given its current cost structure and projected expenses, the Company estimates that its cash, cash equivalents, and short-term deposits should enable it to finance its operations until the middle of the first quarter of 20273. If the Tranche 3 warrants issued in the Structured Financing are exercised in full for proceeds of up to €116.0 million, the Company estimates that such potential additional proceeds would enable it to finance its activities until the middle of the third quarter of 20273. There is no guarantee that the Tranche 3 warrants will be exercised in full, if at all. The audit procedures on the consolidated financial statements have been carried out. The statutory audit report will include a section on the material uncertainty related to going concern and will be issued after verification of the management report. The Company's Board of Directors met on March 27, 2026 and approved the consolidated financial statements for the year ended December 31, 2025. Revenues in 2025 amounted to €4.5 million, compared to €9.2 million generated in 2024. They consisted mainly of the $10 million gross proceeds (net proceeds of €8.5 million) milestone payment invoiced to CTTQ and the $5 million (€4.4 million) credit notes recognized under the license agreement with CTTQ following the closing of the second tranche of the Structured Financing in May 2025. The milestone payment from CTTQ was received in July 2025. Other income amounted to €3.4 million for the full year 2025, as compared to €5.5 million for 2024. Other income mainly consisted of French research tax credit (credit d’impôt recherche) for 2025 and 2024 in the amounts of €2.3 million and €4.9 million recorded in 2025 and 2024, respectively. R&D expenses for the fiscal year ended December 31, 2025, amounted to (€87.0) million compared to (€90.9) million in 2024. This 4% decrease was primarily due to the focus on the development of lanifibranor in MASH, in connection with the pipeline prioritization plan that was implemented in 2025 and, to a lesser extent, to the completion of patient enrollment in its NATiV3 trial in April 2025. Marketing and business development expenses was (€5.0) million for the fiscal year ended December 31, 2025, compared to (€2.0) million in 2024, primarily due to a €2.4 million increase in expenses related to the preparation for the potential commercial development of lanifibranor, if approved. The increase was consistent with the Company's planned pre-commercialization investment plan ahead of the potential NATiV3 data readout. General and administrative expenses (G&A) amounted to (€47.9) million for the fiscal year ended December 31, 2025, an increase of €32.1 million compared to (€15.8) million in 2024, of which €20.3 million related to share-based compensation expenses driven by the changes in governance, management and organization, including the accelerated vesting of equity awards. Other operating income (expenses) amounted to (€9.0) million for the fiscal year ended December 31, 2025, an increase of €5.4 million compared to (€3.6) million in 2024. The 2025 expenses are related to the pipeline prioritization plan implemented in 2025, and its related expenses. Net financial loss was (€212.8) million for the fiscal year ended December 31, 2025, compared to (€86.0) million in 2024. The net financial loss in 2025 was mainly due to (i) non-cash IFRS treatment of the accounting at the fair value, including (€84.7) million related to derivative instruments in connection with the second tranche of the Structured Financing and (€95.1) million from warrants previously issued to the European Investment Bank (“EIB”) and (ii) (€28.9) million, mainly non-cash, in loans and royalty certificates interests expenses. Share of net loss – Equity method was (€0.4) million for the fiscal year ended December 31, 2025, compared to (€0.3) million for the same period in 2024. Income tax amounted to (€0.0) million for the 2025 fiscal year, compared to (€0.3) million for 2024. The Company’s net loss for the full year 2025 was (€354.1), compared to (€184.2) million for 2024. The following table presents Inventiva’s income statement, prepared in accordance with IFRS, for the 2025 financial year, with comparatives for the 2024 financial year. Main areas of progress in the R&D portfolio Lanifibranor in MASH Publication in the peer-reviewed scientific journal Journal of Hepatology of the results from the investigator-initiated proof-of-concept clinical trial evaluating lanifibranor in patients with T2D and MASLD – January 2025 Initiation by Hepalys Pharma, Inc of the clinical development program of lanifibranor in Japan - February 2025 Publication in the peer-reviewed scientific journal Biomedicine & Pharmacotherapy of the results from a preclinical study showing improvement of portal hypertension with lanifibranor treatment – February 2025 Completion of enrollment in the Phase 3 NATiV3 clinical trial evaluating lanifibranor in patients with MASH and advanced fibrosis – April 2025 Publication in the peer-reviewed scientific journal Clinical Gastroenterology and Hepatology of the results of its analysis of new and specific non-invasive signature predictive of histological response in patients with MASH treated with lanifibranor – April 2025 Publication in the peer-reviewed scientific journal Journal of Hepatology Reports on results of lanifibranor treatment on liver sinusoidal endothelial cells in patients with MASLD/MASH and in preclinical models of the disease – July 2025 Other milestones Appointment of Renee Aguiar-Lucander to the Board of Directors – June 2025 Appointment of Jason Campagna, MD, PhD, as President of Research and Development and Chief Medical Officer – July 2025 Appointment of Martine Zimmermann, PharmD, as Executive Vice President of Regulatory Affairs and Quality Assurance – August 2025 Appointment of Andrew Obenshain as CEO of Inventiva – October 2025 Appointment of Nazira Arma as Chief Commercial Strategy Officer – December 2025 Sale of Odiparcil In 2025, the Company completed the sale of its global rights to odiparcil to Biossil, Inc., including without limitation, Inventiva’s preclinical data and results from the positive Phase 2a clinical trial for odiparcil in mucopolysaccharidosis type IV (MPS IV). Under the terms of the agreement, the Company received an upfront payment of $600,000 and may be eligible to receive up to $90 million in potential regulatory and commercial milestones and high single-digit royalties on future net sales, if approved. The Company’s ability to generate revenue from this arrangement will depend on Biossil’s abilities and efforts to successfully develop and seek marketing approval for odiparcil. Because of the numerous risks and uncertainties associated with product development and regulatory approval, there is no assurance that the Company will receive any future payments under this agreement. Termination of the Liquidity Contract The Company announces the termination of the liquidity contract entered into on February 1, 2018, with Kepler Cheuvreux, effective February 27, 2026. At the time the contract was established, the following resources appeared on the liquidity account: Cash: €163,510.42 Number of shares: 34,063 Inventiva shares As of the contract termination date, the following resources appeared on the liquidity account: Cash: €826,388.92 Number of shares: 0 Inventiva shares *** Upcoming key milestones Topline results of NATiV3 – expected in fourth quarter of 2026 Upcoming scientific conference participation EASL Congress, Barcelona, May 27-30 Conference call A conference call in English will be held tomorrow, Tuesday, March 31, 2026, at 8:00 am (New York)/2:00 pm (Paris) to discuss 2025 financial results and business updates. The live webcast may be accessed at the Investors Presentations section of the Inventiva website. In order to receive the conference access information necessary to join the conference call, it is required to register in advance here. Participants will need to use the conference access information provided in the e-mail received at the point of registering (dial-in number and access code). A replay of the conference call and the presentation will be available after the event one the Company’s website. Next financial results publication Revenues and cash, cash equivalents and deposits for the first quarter of 2026: Tuesday, May 26, 2026 (before U.S. market open) About Inventiva Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of oral [small molecule] therapies for the treatment of patients with MASH. The Company is currently evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for the treatment of adult patients with MASH, a common and progressive chronic liver disease. Inventiva is a public company listed on compartment B of the regulated market of Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: IVA). Contacts Avertissement This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included in this press release are forward-looking statements. These statements include, but are not limited to, forecasts and estimates regarding Inventiva's cash resources and expenses, expectations with respect to EIB matters, the potential exercise by investors of warrants and pre-funded warrants, including warrants and pre-funded warrants issued in connection with the Structured Financing, potential milestone and royalty payments the Company may receive under its agreement with Biossil with respect to odiparcil, including the timing thereof, forecasts and estimates with respect to Inventiva’s NATiV3 Phase 3 clinical trial with lanifibranor in patients with MASH, including the quality of trial results, design, duration, timing, costs, and funding, clinical trial data releases and publications, the information, insights and impacts that may be gathered from clinical trials, the potential therapeutic benefits of lanifibranor, potential regulatory submissions, approvals and commercialization, Inventiva’s pipeline and development plans, and Inventiva's future activities, expectations, plans, growth and prospects. Some of these statements, forecasts, and estimates may be identified by the use of words such as, without limitation, “believe,” “anticipate,” “expect,” “intend,” “plan,” “seek,” “estimate,” “may,” “will,” “could,” “should,” “designed,” “hope,” “target,” “potential,” “opportunity,” “possible,” “aim,” and “continue” and other similar expressions. These statements are not historical facts, but rather statements of future expectations and other forward-looking statements based on management's beliefs. These statements reflect the opinions and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance, or events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend on factors beyond Inventiva's control. There can be no guarantee, with respect to product candidates, that clinical trial results will be available on schedule, that future clinical trials will be initiated as planned, that product candidates will receive the necessary regulatory approvals, or that the milestones planned by Inventiva or its partners will be achieved on schedule, or even at all. Future results may differ materially from the anticipated future results, performance, or achievements expressed or implied by these statements, forecasts, and estimates due to a number of factors, including the fact that interim data or data from any interim analysis of ongoing clinical trials do not predict the future results of clinical trials, the fact that the DMC's recommendation does not prejudge any eventual marketing authorization, that Inventiva cannot provide assurance on the impacts of the Suspected Unexpected Serious Adverse Reaction (SUSAR) on recruitment or the final impact on the results or timing of the NATiV3 trial or related regulatory issues, Inventiva is a clinical-stage company with no approved products and no historical revenue, Inventiva has incurred significant losses since its inception, Inventiva has never generated revenue from product sales, Inventiva will need additional capital to fund its operations, without which Inventiva may be required to significantly reduce its activities, delay or discontinue one or more of its research or development programs, expand its activities or capitalize on its business opportunities, and may not be able to continue as a going concern. Inventiva's ability to obtain financing and complete potential transactions on a timely basis, as well as whether, when, and to what extent dilutive instruments may be exercised and by which holders, Inventiva's future success depends on the successful clinical development, regulatory approvals, and subsequent commercialization of lanifibranor, preclinical studies or previous clinical trials are not necessarily predictive of future results, and the results of Inventiva's and its partners' clinical trials may not support Inventiva's and its partners' claims regarding product candidates, Inventiva's expectations regarding its clinical trials may prove to be incorrect, and regulatory authorities may require additional stops and/or modifications to Inventiva's clinical trials. Inventiva's expectations regarding the clinical development plan for lanifibranor for the treatment of MASH may not be realized and may not support the approval of a New Drug Application, Inventiva's ability to implement its commercialization, marketing, and manufacturing capabilities and strategy, Inventiva's ability to successfully cooperate with its existing partners or enter into new partnerships, and to fulfil its obligations under any agreements entered into in connection with such partnerships, the benefits of its current and future partnerships on the clinical development, regulatory approvals, and, if applicable, commercialization of its product candidates, as well as the achievement of milestones and timelines anticipated in connection with such partnerships, Inventiva and its partners may encounter substantial delays beyond expectations in their clinical trials or fail to demonstrate safety and efficacy to the satisfaction of the applicable regulatory authorities, the ability of Inventiva and its partners to recruit and retain patients in clinical studies, the recruitment and retention of patients in clinical trials is a costly and time-consuming process that could be made more difficult or impossible by multiple factors beyond the control of Inventiva and its partners, Inventiva's product candidates may cause adverse reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces significant competition, and Inventiva's activities, preclinical studies, and clinical development programs, as well as timelines, Inventiva's financial condition and results of operations could be materially and adversely affected by changes in laws and regulations, adverse conditions in its industry, geopolitical events, such as the conflict between Russia and Ukraine and the resulting sanctions, the conflict in the Middle East and the related risk of a wider conflict, epidemics, and macroeconomic conditions, including changes in international trade policies, global inflation, fluctuations in financial and credit markets, customs duties and other trade barriers, political unrest and natural disasters, uncertain financial markets, and disruptions in banking systems. In light of these risks and uncertainties, no representation is made as to the accuracy or completeness of these forward-looking statements, forecasts, and estimates. Furthermore, forward-looking statements, forecasts, and estimates are only valid as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Please refer to the Universal Registration Document for the fiscal year ended December 31, 2024, filed with the Autorité des Marchés Financiers on April 15, 2025, the semi-annual financial report as of June 30, 2025, published on September 29, 2025, and the Annual Report on Form 20-F for the fiscal year ended December 31, 2024 filed with the Securities and Exchange Commission (the “SEC”) on April 15, 2025 and the Half-Year Report for the six months ended June 30, 2025 on Form 6-K filed with the SEC on October 15, 2025 for other risks and uncertainties affecting Inventiva, including those described under the heading “Risk Factors,” and in future filings with the SEC. Other risks and uncertainties that Inventiva is not currently aware of may also affect its forward-looking statements and may cause actual results and timing of events to differ materially from those anticipated. All information contained in this press release is current as of the date of this release. Except as required by law, Inventiva has no intention or obligation to update or revise the forward-looking statements mentioned above. Therefore, Inventiva accepts no responsibility for the consequences arising from the use of any of the above statements. 1 Short-term deposits were classified as “other current assets” in the consolidated statement of financial position in accordance with IFRS and were considered by the Company to be liquid and readily available. 2 Based on the exchange rate of €1.00 = $1.1576 as published by the European Central Bank on November 12, 2025. See press release of November 17, 2025. 3 This estimate is based on the Company's current business plan , but excludes potential milestone payments to be paid or received by the Company, any potential proceeds from the exercise of Tranche 3 warrants issued as part of the Structured Financing, as well as any additional expenses related to other product candidates or resulting from the licensing or acquisition of additional product candidates or technologies, or any related developments that the Company may pursue. The Company may have based these estimates on assumptions that are incorrect or may amend its business plan in the future, and the Company may end up using its resources sooner than anticipated. These estimates may be shortened in the event of an increase, beyond the Company's expectations, in expenditure relating to the development program, or if the development program of the Company progresses more quickly than expected. Attachment Inventiva - PR - Full Year results 2025 - EN - 03 30 2026

Related articleQuarter not tagged2026-03-31

Inventiva Q4 Earnings Call Highlights

MarketBeat
Inventiva has centralized its strategy around lead candidate lanifibranor and the global Phase 3 NATiV3 trial, which completed enrollment in April 2025, but there is ambiguity on the expected top-line readout timing—management formally updated it to Q4 2026 while several executives repeatedly referred to “Q4 of this calendar year.” NATiV3 is a large randomized, double-blind, placebo-controlled study with over 1,000 patients in the main F2–F3 cohort plus ~410 in an exploratory F1–F4 cohort (including ~75 with cirrhosis), includes a meaningful diabetic population and background GLP‑1/SGLT2 use, and uses two Phase 3 doses (800 mg and 1,200 mg) with dropout rates confirmed below the 30% covenant threshold. As of Dec. 31, 2025 Inventiva held EUR 230.9 million in cash and short-term deposits, which management says funds the company beyond the NATiV3 readout with runway to the middle of Q1 2027 (extendable to mid‑Q3 2027 if tranche‑three warrants generate up to an additional EUR 116 million), and the company sold odiparcil rights with up to $90 million in potential milestones plus royalties. Interested in Inventiva S.A. Sponsored ADR? Here are five stocks we like better. Inventiva (NASDAQ:IVA) used its full-year 2025 results call to outline a company-wide focus on advancing its lead candidate lanifibranor toward a potential approval in metabolic dysfunction-associated steatohepatitis (MASH), while also detailing a strengthened cash position and several strategic organizational changes. Chief Executive Officer Andrew Obenshain said that since joining the company about six months ago, he has aligned “every resource, every decision, and every member of this team” behind advancing lanifibranor in MASH. → Coursera's Options Anomaly: A Big Bet on What's Next? Obenshain highlighted Inventiva’s global Phase 3 NATiV3 trial as the company’s central priority, calling completion of enrollment in April 2025 a “landmark operational milestone.” He also said the company is “updating the expected timing of our top-line readout to Q4 2026,” describing the change as reflecting “disciplined sequencing of our clinical and biostatistical milestones.” However, during the call, executives also repeatedly referred to a top-line readout expected in the fourth quarter of “this calendar year,” including Chief Medical Officer and President of R&D Jason Campagna, who said the company anticipate…Read full document

Inventiva has centralized its strategy around lead candidate lanifibranor and the global Phase 3 NATiV3 trial, which completed enrollment in April 2025, but there is ambiguity on the expected top-line readout timing—management formally updated it to Q4 2026 while several executives repeatedly referred to “Q4 of this calendar year.” NATiV3 is a large randomized, double-blind, placebo-controlled study with over 1,000 patients in the main F2–F3 cohort plus ~410 in an exploratory F1–F4 cohort (including ~75 with cirrhosis), includes a meaningful diabetic population and background GLP‑1/SGLT2 use, and uses two Phase 3 doses (800 mg and 1,200 mg) with dropout rates confirmed below the 30% covenant threshold. As of Dec. 31, 2025 Inventiva held EUR 230.9 million in cash and short-term deposits, which management says funds the company beyond the NATiV3 readout with runway to the middle of Q1 2027 (extendable to mid‑Q3 2027 if tranche‑three warrants generate up to an additional EUR 116 million), and the company sold odiparcil rights with up to $90 million in potential milestones plus royalties. Interested in Inventiva S.A. Sponsored ADR? Here are five stocks we like better. Inventiva (NASDAQ:IVA) used its full-year 2025 results call to outline a company-wide focus on advancing its lead candidate lanifibranor toward a potential approval in metabolic dysfunction-associated steatohepatitis (MASH), while also detailing a strengthened cash position and several strategic organizational changes. Chief Executive Officer Andrew Obenshain said that since joining the company about six months ago, he has aligned “every resource, every decision, and every member of this team” behind advancing lanifibranor in MASH. → Coursera's Options Anomaly: A Big Bet on What's Next? Obenshain highlighted Inventiva’s global Phase 3 NATiV3 trial as the company’s central priority, calling completion of enrollment in April 2025 a “landmark operational milestone.” He also said the company is “updating the expected timing of our top-line readout to Q4 2026,” describing the change as reflecting “disciplined sequencing of our clinical and biostatistical milestones.” However, during the call, executives also repeatedly referred to a top-line readout expected in the fourth quarter of “this calendar year,” including Chief Medical Officer and President of R&D Jason Campagna, who said the company anticipates sharing top-line results in “Q4 of this calendar year.” Obenshain similarly reiterated that the “anticipated top-line readout in the fourth quarter of this year” is an inflection point for the company. → HP Inc. Stock Is Historically Cheap, but Can AI Change the Story? Campagna described lanifibranor as a small-molecule therapy designed to activate all three PPAR isoforms—alpha, delta and gamma—in a “balanced manner,” with the goal of inducing antifibrotic, anti-inflammatory, and metabolic effects in a single oral therapy. He said lanifibranor was the first asset in Inventiva’s Phase 2b NATIVE trial to achieve statistical significance on a composite endpoint combining fibrosis improvement and MASH resolution after 24 weeks, with a “favorable safety and tolerability profile.” Based on the Phase 2b results, Campagna said the FDA granted the drug breakthrough therapy and fast track designations. → MercadoLibre Stock Is in Deep Pullback Territory: Time to Buy? NATiV3 is a randomized, double-blind, placebo-controlled study in biopsy-confirmed MASH patients with F2 or F3 fibrosis. Campagna said Inventiva deliberately designed the study to reflect both the Phase 2b population and “the real world,” including a meaningful proportion of patients with type 2 diabetes and other metabolic comorbidities and some patients using background GLP-1 and/or SGLT2 inhibitors. Enrollment surpassed original targets, he said, with “over 1,000 patients in the main cohort” and an additional “410 patients” in an exploratory cohort spanning fibrosis stages F1 through F4. In Q&A, Guggenheim’s Seamus Fernandez asked about trial dropouts. Campagna said Inventiva’s 2024 structured financing included covenants tied to early termination rates, with the trial needing to remain below a 30% threshold. He said the company previously disclosed it was below that threshold at the time follow-on tranches were released and added that Inventiva can “confirm we are well within that range” and that management remains confident the trial is “well powered to detect the primary endpoint” given the observed early terminations. Fernandez also asked about the two Phase 3 doses (800 mg and 1,200 mg). Campagna said it is “very reasonable” to think the 800 mg dose could show a deeper effect over a longer treatment period because PPARs are transcriptional modulators and “six months is relatively thin for a PPAR.” He added that fluid-retention-related weight gain is traditionally associated with PPAR gamma agonism and is “highly likely to be dose dependent,” which could make a lower dose meaningful from a tolerability perspective if efficacy remains strong. Piper Sandler’s Dominic Pannarale asked about biopsy quality control and safety monitoring. Campagna outlined multiple quality checkpoints for biopsies, including bedside procedures, assessments of biopsy length and core quality, slide preparation checks prior to central reading, and ongoing tracking of whether readers remain on time with paired-biopsy review per protocol and analysis plan. On safety monitoring committees, Obenshain said meetings occur every six months and noted that “you would know if they had said anything,” adding that the company could not provide additional details beyond that. UBS’s Michael Yee asked about weight gain and cardiovascular risk. Campagna said Inventiva has previously disclosed, based on a blinded look at NATiV3 in September 2024 and from the one-year FASST trial in systemic scleroderma, that fluid-retention weight gain “does appear to plateau.” He also said it is possible weight could come down in some patients, pointing to the LEGEND study and stating that when patients received SGLT2 inhibition alongside lanifibranor, there was “almost no weight gain at all.” On cardiac concerns, Campagna said the company has not been seeing congestive heart failure as a clinical issue in its program, while emphasizing that the company continues to monitor for it and expects ongoing dialogue with the FDA. Obenshain framed MASH as underdiagnosed and undertreated but improving in awareness and screening. He cited an estimate of “18 million people in the U.S. living with MASH,” adding that “only around 10% have been diagnosed,” which he said is up 25% versus 2024 estimates. He also said that among diagnosed patients with clinically actionable F2 or F3 disease, “only around 40% are currently under the care of a treating physician.” When asked about commercial opportunity and competition, Obenshain said that if Inventiva can replicate the Phase 2 fibrosis effect—an “18% effect on the fibrosis”—the company believes it will have “an excellent drug” and “clearing efficacy” needed for an attractive market opportunity. He added that Inventiva sees a potential entry point in the “F3 diabetic patient population,” citing the combination of fibrosis effect and HbA1c lowering. In response to questions about the size of the treated population, Obenshain said Inventiva’s market research indicates “about 375,000 patients total F2, F3, in treatment or care right now.” He also said “55%–65% of the patients are diabetic,” and that the distribution splits roughly 50/50 between F2 and F3. On background GLP-1 use in NATiV3, Campagna said about “14% or so” of the population across cohorts were on GLP-1 therapy at randomization. He suggested the impact on treatment response should be minimal because patients still entered the trial with active disease, and he added that doses used in this setting are “the diabetic doses.” Several analysts asked about the exploratory F4 cohort and potential outcomes trial planning. Campagna said the company expects the exploratory cirrhotic population to inform safety and pharmacology questions and help Inventiva understand disease progression and event rates for planning a future outcomes-driven trial the company is referring to as “NATiV4.” He also said there are “approximately 75 patients” with cirrhosis in that exploratory cohort, and that the patients are compensated by definition, with a spectrum of portal hypertension severity. Campagna also addressed questions on regulatory requirements for a confirmatory trial in the context of conditional approval. He said the detailed expectations are discussed with FDA during pre-NDA and review interactions, but characterized the general framework as requiring a confirmatory trial to be “meaningfully underway” at the time of filing, with continued progress evaluated at mid-cycle review. Chief Financial Officer Jean Volatier said that as of Dec. 31, 2025, Inventiva held “EUR 230.9 million” in combined cash equivalents and short-term deposits, supported by two financings in 2025: the second tranche of a 2024 structured financing in May (about “EUR 108 million” net proceeds) and a U.S. registered public offering in November (about “EUR 139.4 million” net proceeds). Volatier said the company estimates it is funded “beyond our anticipated NATiV3 readout.” Based on the current operating plan and cost structure, he said cash runway extends to “the middle of Q1 2027,” and to “the middle of Q3 2027” assuming full exercise of tranche three warrants that could generate up to “an additional EUR 116 million.” On expenses, Volatier reported: R&D expenses: EUR 87 million for the full year, reflecting pipeline prioritization and completion of NATiV3 enrollment in April 2025. Marketing and business development: EUR 5 million, driven by planned pre-commercial investment in anticipation of a potential lanifibranor launch. G&A expenses: EUR 47.9 million, including about EUR 20.3 million in non-cash share-based compensation tied to governance and organizational transition. Obenshain also noted that Inventiva sold global rights to odiparcil to Biosil in Q4 2025 as part of its strategic focus, and said the company may receive up to $90 million in potential regulatory and commercial milestone payments, plus potential “high single-digit royalties” on future net sales if approved. Looking ahead, management said it is building regulatory and commercial readiness in a “lean and targeted way.” Obenshain said the regulatory and quality functions are fully staffed, while the commercial team is focused on strategic planning—such as market access, market research and medical affairs—without a major commercialization headcount build prior to data. Inventiva (NASDAQ: IVA) is a clinical‐stage biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapies for the treatment of metabolic, inflammatory, and fibrotic diseases. The company's core expertise lies in the modulation of nuclear receptors and signaling pathways that regulate fibrosis, inflammation and metabolic dysfunction. Inventiva's scientific platform integrates medicinal chemistry, in vitro and in vivo pharmacology, and translational sciences to advance a diversified pipeline of therapeutic candidates. The company's lead asset, lanifibranor (IVA337), is a pan-PPAR agonist in Phase III development for nonalcoholic steatohepatitis (NASH) and has demonstrated anti-inflammatory and anti-fibrotic effects in preclinical and clinical studies. The article "Inventiva Q4 Earnings Call Highlights" was originally published by MarketBeat.

TranscriptFY2025 Q42026-03-31

FY2025 Q4 earnings call transcript

Earnings source - 116 paragraphs
Operator

Good day, and thank you for standing by. Welcome to the Inventiva Full Year 2025 Financial Report webcast and conference call. At this time, all participants are in 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 one and one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one and one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to speakers today, David Nikodem, Head of Investor Relations. Please go ahead.

David Nikodem

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 investor 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 two of the slides and our SEC and AMF filings for a discussion of associated risks.

David Nikodem

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 three. Andrew?

Andrew Obenshain

Thank you, David. Good morning, good afternoon to everyone, and thank you for joining us. Since joining Inventiva six 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 that the data from the NATiV3 trial, if positive, has the potential to carry weight with regulators, physicians, and most importantly, with patients.

Andrew Obenshain

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 Biosil, and we may receive up to $90 million in 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.

Andrew Obenshain

Jason Campagna joined as CMO and President of R&D. Martine Zimmermann joined as a new EVP and Head of Quality and Regulatory Affairs. 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. The opportunity is real. MASH has been underdiagnosed and undertreated for too long, but that is changing. More patients are being identified, more are 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.

Andrew Obenshain

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. 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.

Andrew Obenshain

I will now turn the floor over to Jason, who will give a brief update on lanifibranor, our differentiated oral antifibrotic and a potential new treatment option that we believe addresses the remaining unmet medical needs in MASH.

Jason Campagna

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 antifibrotic, 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.

Jason Campagna

Lanifibranor was the first asset to achieve statistically significant improvement in the composite endpoint of both fibrosis improvement and MASH resolution in our phase II-B NATIVE trial after just 24 weeks of treatment with a favorable safety and tolerability profile. On the basis of these results from our phase II-B, the FDA granted lanifibranor both 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.

Jason Campagna

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. At six months in our phase II-B, the 1,200 mg dose of lanifibranor showed a 24% treatment effect. NATiV3 was also deliberately designed to mirror the patient population of our positive phase II-B and the real world as it exists today.

Jason Campagna

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 2025, we completed enrollment, exceeding our original targets with over 1,000 patients in the main cohort and 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 this field and for the patients who need new treatment options. I will now turn the floor over to Jean for our financial review.

Jean Volatier

Thank you, Jason. Good morning and good afternoon, everyone. Yesterday evening, we issued our press release with our full financial results for the year ending 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 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. 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.

Jean Volatier

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 three 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 potential launch of lanifibranor, if approved.

Jean Volatier

G&A expenses of EUR 47.9 million include approximately EUR 20.3 million of non-cash 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.

Andrew Obenshain

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, and we will now open the floor for questions. Operators, please go ahead and provide instructions for the Q&A session.

Operator

Thank you. To ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. Please, may we ask you that you limit yourself to one question each. We will now take our first question. Our first question for today comes from the line of Seamus Fernandez from Guggenheim. Please go ahead.

Seamus Fernandez

Great. Thanks, guys. 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 just wanted to get a sense of where the dropout rate was, you know, 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 1200 milligram dose, in terms of both weight gain and then ultimately on fibrosis?

Seamus Fernandez

Is the sort of change from a you know more typical 12-month endpoint to the 18-month endpoint geared to kind of have the 800 mg dose catch up to the 1200 but also manage the you know potential tolerability or weight gain issues? The last question is just you know what you're seeing in terms of the overall market interest. You know, Madrigal continues to see very strong uptake you know in the U.S. How are you thinking about the opportunity to you know compete with Madrigal? What do you think is the threshold necessary? Andrew, you mentioned 18%.

Seamus Fernandez

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? Thanks.

Andrew Obenshain

Morning, Seamus. Thanks for the questions. I'm actually gonna take your third one first and then hand the first two over to Jason. Yes, just to be really direct, we think that if we replicate the phase II trial and have an 18% effect on the fibrosis, we have an excellent drug. That is the clearing efficacy that we need for in order to have a very attractive market opportunity. We continue to see a lot of market growth thanks to the entry of, you know, 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.

Andrew Obenshain

At 18% of fibrosis effect with our HbA1c lowering, we have a very good profile for that. Let me then turn the question over to Jason first on the drop-offs and what we've last discussed publicly there, and then the second question about the 800 catching up to the 1200 dose.

Jason Campagna

Hey, Seamus. Let's take the first one. You are correct. As part of the structured financing from 2024, there were covenants in there 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 when the trial was built allowed for up to a 30% dropout rate. That was the metric that was used, and we had disclosed publicly at the time of both the first and the second tranche release, which would have been in April 2025, that we were below that threshold.

Jason Campagna

I think now that we're tightening the guidance to Q4 of this calendar year, I think we are 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. The second question you asked about the two doses, I think you're landing sort of in the right mixture 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 800 mg dose will have time to sort of catch up to the 1200. It was already quite a good dose back in NATIVE, as you recall.

Jason Campagna

Six months is relatively thin for a PPAR, which is a transcriptional modulator to sort of do its work. The idea that you could see a deeper effect with that 800 dose at 18 months is very reasonable. I think where you're landing around the potential dose responsiveness of the tolerability concerns, that is also very important to us. Take weight gain, which you mentioned. Weight gain is 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.

Jason Campagna

We think that potential to have really strong efficacy with both doses, which we were able to show in NATIVE, but may have a different tolerability profile at the lower dose, could be meaningful for patients. It's our hope that both will be positive, and we'll have that opportunity to discuss that with regulators.

Seamus Fernandez

Great. Thanks so much.

Operator

Thank you. Our next question comes from the line of Yasmeen Rahimi from Piper Sandler. Please go ahead.

Dominic Pannarale

Hi, this is Dominic on for Yas. Congrats on the great quarter, and thank you for taking our questions. The first one, we know that NATiV3 is a very large dataset. As we're getting closer to top-line data in Q4, what are some of the quality control, I guess, 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, I guess, how, if you had any recent safety monitoring committee, and are you seeing anything on a blinded basis on the safety profile? Any color there would be helpful. Thank you.

Andrew Obenshain

Good morning, Dominic. Two questions. Let me actually take the second one first. I'm gonna hand 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.

Jason Campagna

Yeah. Thanks, Andrew. Dominic, quality control and biopsy. Let me start by saying that the team we have here is outstanding. The clinical operation, the clinical development team have been immersed in the world of NASH clinical trials for the better part of a decade. This is something that they know well, and we carry that expertise forward. You could think of quality control of biopsy around three issues. Are we hurting the patient? Meaning at the bedside, are we doing the right things? Second, are we capturing the biopsy according to standard practice? That's the length of the biopsy, the overall quality of the core, if you will. There's measurements and things that sort of go in to say check or not check.

Jason Campagna

We have reviewed all of those and continued to do so right up until when we get to last patient, last visit later this year. Lastly, finally, when the slides are sectioned prior to going off and being read, there's a quality control step there that looks at what actually gets made onto the slide. Afterwards, at that point, we are obviously blinded to all of that information, but there is a quality check in terms of are the reviewers, the readers staying on time and on track reading biopsies in the paired manner that's 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're doing exactly the right work to keep us on track.

Dominic Pannarale

Great. Thank you.

Operator

Thank you. Our next question for today comes from the line of Ritu Baral from TD Cowen. Please go ahead.

Ritu Baral

Good morning, guys. Thanks for taking the question. I want to drill down a little bit more upon final powering. You guys disclosed the over 1000 final patient number. I think it's 1009, 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, you know, the final primary endpoint? And then I have a follow-up on market expectations around that F3 diabetic population that was mentioned.

Andrew Obenshain

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

Jason Campagna

Hi, Ritu. Good morning. On the first one, you know, we are not guiding to the actual effect size, but I can reiterate for you and for everyone what we have been saying. First, we are with a sample size of over 1,000 patients. We are powered to over 90% on a primary endpoint of the composite fibrosis improvement one stage or more MASH resolution. That one has a higher placebo response than we showed in NATIVE, which as you know, was 7%. Two, a smaller treatment effect than we showed in NATIVE at the 1,200 milligram dose. That means the overall effect size that we are powered to is smaller. A much more conservative view than the actual data that we showed in the phase II program.

Jason Campagna

I think we just talked earlier with Seamus that alongside our comfort with the early termination rates we have, we feel very good that the trial is structurally sound and that will give us an answer to the question one way or the other. You know, did lanifibranor work first at the 1,200 mg dose? The testing is hierarchical. We can't get to the 800 unless you went on the 1,200. But that is the core question. We think the trial is well set up to deliver an answer to that question that is well powered and highly confident. I think to your second question around placebo response, the individual endpoints of fibrosis alone, I think everybody on the call knows this, fibrosis alone improvement or MASH resolution alone can be quite noisy.

Jason Campagna

It's not clear after all these years of study why that is, but we do know that they're noisy. On the other hand, the composite endpoint, the primary endpoint of NATiV3, are with us and other sponsors, have shown that that endpoint is much less prone to placebo response. That makes sense, Ritu, biologically, right? You have in one patient, they may, on a placebo response, move their fibrosis stage by one point or more. The idea that they can also resolve their MASH spontaneously, what that 7% tells you is that in the wild, in the real world, that's incredibly uncommon, and that makes total sense with the actual way that patients walk in. It is unusual if you leave them sort of sitting alone without treatment, that both of those things will get better on their own.

Jason Campagna

The placebo response there actually reflects, we believe, the underlying biology, and it should remain very low. We've seen it by precedent, and it's our expectation for the trial that we're running.

Ritu Baral

Very helpful. Andrew, question on how you guys in 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?

Andrew Obenshain

Yeah. Thanks for the question, Ritu. In terms of size, there's about 375,000 patients total F2, F3, in treatment or care right now, the largest segment is. Or one of the largest segments is that F3 diabetic patient population, being 55%-65% of the patients are diabetic, and about it splits roughly 50/50 in our market research between F2, F3. That patient population is quite a large patient population overall. In terms of growth, we don't have the granularity down to that segment. However, I would just note anecdotally that F4 is one of the fastest-growing segments.

Andrew Obenshain

I think the diagnosis rates are increasing quite a bit, overall for F2, F3, F4, just due to the number of entrants into the market. They are growing at minimally proportionate with the market, in that segment.

Ritu Baral

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

Andrew Obenshain

I'll pass that question.

Jason Campagna

Yeah. Confirming you're talking about the exploratory cohort, correct? Yeah.

Ritu Baral

Exploratory cohort, yes.

Jason Campagna

We do have F4s in that cohort. They would have screen failed in that case by histology, potentially other lab values for the actual main cohort in NATIVE. They represent a sort of range of F4 from. They're all compensated by definition, meaning they've had no clinical outcome events, decompensation events. Their range of severity with portal hypertension can be from none to evidence of clinically significant. That data set is going to 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'll have them at topline per se, or in the weeks that follow it in one way or another. I think as we get closer to topline data, we should be guiding on that more tightly.

Ritu Baral

Got it. Looking forward to that. Thanks for taking all the questions.

Andrew Obenshain

Okay. Thank you.

Operator

Thank you. Our next question today comes from the line of Thomas Smith from Leerink Partners. Please go ahead.

Thomas Smith

Hey, guys. Good morning. Thanks for taking the questions, and congrats on all the progress. Just wanted to follow up on that F4 population. I know you're capturing some of those patients in the exploratory cohort. Can you just 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 F4 pending the NATiV3 data and perhaps how you're thinking about perhaps how some of those plans could change. We know we're going to get F4 outcomes data for Rezdiffra also in 2027. Some interesting timing around that data set relative to when you're planning on starting this F4 outcome study. Thanks so much.

Andrew Obenshain

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

Jason Campagna

Tom, good morning. There's a lot there. Let me make sure I get it all for you. One, just in general, what are we expecting to learn from that cirrhotic population in the exploratory cohort? First, above all else, safety of lanifibranor in that population. Clearly, right, if you're going to bring in a new therapeutic into a more, let's say, just sicker population, you want to obviously have safety headroom to do that. The approximately 75 patients we have in that cohort, safety above all else. Second, it's not that, as you know, that cohort is not tracked systematically for efficacy. That being said, we do anticipate having data of things on like LFTs, transaminases, and other things that would point directionally towards whether the drug is biologically active.

Jason Campagna

Really a pharmacology question, very important. We have done ad hoc impairment studies with the drug, but looking at it in the real world in a clinical trial would be incredibly helpful. I think lastly, it will give us a sense in our own hands of how those patients progress over time to later-stage disease. You can read about it, you can model it, you can look at other people's trial, but in your own trial, we will see how many of those patients go on to actually have liver-related or other events. That will be incredibly helpful as we think about powering and sizing of an outcome-driven trial, which is what we're, you know, right now calling NATiV4, for lack of a better term. Make sure that that gets your question, Tom, on the value of that cohort to us.

Thomas Smith

Yep, that's helpful.

Jason Campagna

Great. Look, you note the Madrigal data coming, and then yet we acknowledge that. We agree. I think our view is that positive data, if Madrigal were to show it, would only be helpful for the field, period, full stop. The idea that we have now finally shown that the surrogate endpoint does correlate with clinical outcomes would be an enormous win for the field. Look no further than what happened in the cardio renal division with proteinuria in the last six years. You know, proteinuria was issued as a surrogate in 2019. Now you have five or coming six approved therapeutics for IgAN. That's an enormous win for patients. We expect something like that would, I hope, happen here.

Jason Campagna

Clearly, that would influence our thinking about how we think about populations and the ones that are most likely to develop liver-related outcomes because we'd want to get more of them since we know that the sort of door is open to show that the histology will map to clinical outcomes.

Thomas Smith

Very helpful. Thanks for taking the questions.

Operator

Thank you. We are now going to take our next question, and our next question comes from the line of Michael Yee from UBS. Please go ahead.

Michael Yee

Thanks. Good morning. I have 32 questions myself. First question is on weight gain. Can you remind or confirm the view that, based on the phase II also, I think what you've sort of 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 the phase II, and that that plateaus, and that was initially seen in the phase III and therefore no concerns. The second question is there any view that either because of other drugs or because of longer time duration of 18 months versus six months here that that could actually come down in some of those patients or at least come back down to baseline? Is that possible?

Michael Yee

The third question is around getting the regulators comfortable with that what I guess fluid retention effect in some patients, and that there would be presumably no at least initial cardiac imbalance in any of the arms that you see and would you be able to talk about no imbalance in any cardiovascular events numerically or any SAEs of that nature in when you disclose the data in the fourth quarter? Thanks, guys.

Andrew Obenshain

Thank you for the question, Mike. You were a little soft, so I'm just gonna repeat some of it. There's a question about does weight gain indeed plateau, and number one, if in the phase II. Number two, is there a chance that that weight gain would actually go down in the phase III, either due to concomitant medications or longer treatment? Number three, some of the weight gain is if the weight gain is due to fluid, is there any concerns about a cardiac imbalance in the trial? For those three questions, I'll hand it over to Jason.

Jason Campagna

Yeah. Mike, good to talk to you again. Good morning. We have previously said, and we'll reaffirm it here, that the data that we have previously shown from the blinded look at NATiV3 back in September 2024, and that we also disclosed at that time the FASST clinical trial in systemic scleroderma, which was a one-year trial with treatment of lanifibranor, same doses in NATiV3, 800, 1200 milligrams, that the weight, the fluid retention weight gain does appear to plateau. I think we don't have any additional information to guide on that publicly, but I think that's what we've seen in both of the clinical trials so far. I think second, do we expect the weight to come down? Well, it's well possible.

Jason Campagna

I think there are a couple of factors at play. Take the LEGEND study, for example. We show that when patients are given SGLT2 inhibition in parallel with lanifibranor, that there's almost no weight gain at all. There are many patients in the trial that are on SGLT2 inhibition. I do not have the number for you off the top of my head. We know that patients can be started on those therapeutics for management of diabetes or any other reason. It is entirely possible and reasonable to believe that if patients are getting SGLT2 inhibitors or other diuretics to manage blood pressure, et cetera, that the fluid retention could be blunted or resolved so that the final landing spot, if you will, for any patient might be lower than the peak weight gain that they had in the trial.

Jason Campagna

I think we'll see what the data show. Last thing in terms of regulators, I think, I can't speak for the FDA, but I can only speak to what I've read, of everything they've put out. The fluid retention is a known phenomenon with PPAR gamma agonism. The thing about lanifibranor is it was designed to be different than other PPAR gammas, and we'll see what the data show. Our view is that it is a very different type of PPAR agonist. But that being said, the PPAR gamma is a known effect. It is on target. It is not idiosyncratic in any way. FDA has shown with labeling and other work that they are comfortable with fluid retention.

Jason Campagna

I think you're hitting on the right point, the cardiac, and as we've talked about and guided publicly, over the years, we are not seeing congestive heart failure as a clinical issue in our program. It doesn't mean that we don't follow it, and it doesn't mean that you're thinking about how fluid retention may lead to that. That's certainly in the PPAR labels today, the gamma agonist. It is just not something that we are generally seeing in our program, but we will be paying careful attention to it, and it's a dialogue we'll have with FDA.

Michael Yee

Super helpful. Thank you, guys. Very good.

Operator

Thank you. As a reminder, to ask a question, you will need to press star one and one on your telephone. In the interest of time, we kindly ask to limit yourself to one question each. Our next question comes from the line of Ellie Merle from Barclays. Please go ahead.

Jasmine Kaur

Hi, this is Jasmine on for Ellie. Thank you for taking our question. Just kind of 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.

Jason Campagna

Mm-hmm.

Jasmine Kaur

Do you have a specific bar for what competitive data would look like in this population? And then specifically, how many type 2 diabetes patients do you think have undiagnosed MASH? And how do you plan to work to increase the diagnosis in this population and unlock that segment? Thank you.

Andrew Obenshain

Hi. Hi, Jasmine. I'll take those two questions. First of all, just the diabetes and overlap with MASH, it is enormous, right? I think there's about 18 million patients in the U.S. with undiagnosed MASH. At least half of those or more have diabetes. That is obviously way more than that 375 under the treat or care. The way we see the market evolving is we've seen since about 2004, that market's grown about 20%. It's really quite robust growth, and we do anticipate that to grow nicely. We, as a company, probably will not be pushing diagnosis, at least initially.

Andrew Obenshain

There are enough patients coming in that we can focus on the existing patients being diagnosed. That would obviously. Maybe a later marketing strategy would be to actually increase diagnosis. Your first question. I'm sorry, I forgot your first question already. What was that first question?

Jasmine Kaur

Just if you have like a specific bar in that population for what competitive data looks like?

Andrew Obenshain

Yeah. In terms of competitive data, the way we look at this is that the differentiated profile that we have is we work both on the liver and we're extrahepatic. We work on the body, and we work on the liver. We have direct anti-fibrotic effects. Again, as I said that, you know, an 18% effect size, if we duplicated that in the phase III trial, we feel like a very competitive drug. The other thing we'll be looking at is HbA1c lowering, which was on average across the whole patient population, diabetic and nondiabetic in the phase II, was just over half a point. That would be an approvable diabetes medication years ago.

Andrew Obenshain

That combination of HbA1c lowering, combined with triglyceride lowering, HDL raising, and the fibrosis effect, we think has an extremely attractive profile for that diabetic F3 patient.

Jasmine Kaur

Okay. Awesome. Thank you.

Operator

Thank you. Our next question comes from the line of One second. Lucy Codrington from Jefferies. Please go ahead.

Lucy Codrington

Hi there. Thank you for taking my question. Just one left, please. Regarding the confirmatory trial, just wanted to confirm, 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? Related to that, is starting that trial included in that mid-3Q cash runway with the third tranche of warrants? Thank you.

Andrew Obenshain

Yes, it is included. Starting that trial is included in the cash runway of that mid-Q3 runway. Jason, you wanna talk about what's necessary.

Jason Campagna

Yeah.

Andrew Obenshain

For the trial?

Jason Campagna

Lucy, I think you have the broad brushstrokes of it right, but just something on the language. Accelerated approval is only at the time of the review. What we're looking to get is conditional approval under Subpart H, which is you get marketing authorization, and then the trial, as you note, confirms your surrogate, and then you get full approval. Whether accelerated is only a question of how long it takes the FDA to actually review the file. With that, just trying to make sure that we're all clear on that. You have the broad brushstrokes, right? The individual rules are discussed with each sponsor at the time of the pre-NDA meeting and then during the mid-cycle review.

Jason Campagna

The general framework is you need to have most of the trial structurally in place, protocol approved, at the time you are filing the drug, and it needs to be moving on. The definition of moving is going to be something FDA will define for us. We will be prepared. We'll have our CROs selected, the protocol is approved. May even have sites open. All of that is in the future, but at the time we file, we will meet the FDA position of trial meaningfully underway. At the mid-cycle review, you need to show continued progress on that, so they will check again. That may be a much more detailed look around enrollment curves, site activation curves, et cetera.

Jason Campagna

Again, each sponsor has their own detailed agreement with FDA on that, and it is our plan, of course, not only to have those conversations, but to make sure that we're meeting those requirements so that when we are offered, if we're fortunate enough to make it there, and we are offered, the conditional approval, that trial will be well underway at that point.

Lucy Codrington

Got it. Thank you, and thank you for clarifying on the terminology.

Operator

Thank you. Our next question for today comes from the line of Annabel Samimy from Stifel. Please go ahead.

Jayed Momin

Hi, this is Jayed on for Annabel. Congrats on the progress and thank you for taking my questions. Just two from me. The first one is around the use of background GLP-1 in the trial. What are your expectations on the potential impact of having that background GLP-1 use on lanifibranor effect size for those patients? My second question is around the AIM-MASH tool that was newly FDA qualified as a supportive tool to help with histological assessment. Do you have any plans to maybe leverage that to control or minimize variability? Thank you.

Andrew Obenshain

Yeah. Thanks for the questions on the impact on the lanifibranor effect size based on background GLP-1 and then the trial. Go ahead, Jason.

Jason Campagna

Yeah. In confirming, we do have, and we've previously shared that we have about 14% or so of the population in NATiV3, that's across both cohorts, that have background GLP-1 use at the time of randomization. That could be semaglutide, older drugs, liraglutide, dulaglutide, et cetera, so it's not only limited to the modern GLP-1. I think its effect on treatment response should be minimal and that should. It will sound tongue in cheek, it's not intended to be. It's because when you enter the clinical trial, independent of what drugs you're on, whether you've lost weight by any other measure independent of a GLP-1, you're entering the trial because you have F2, F3 disease with active MASH. So whatever it is, one, those drugs are not doing it for you or your lifestyle modifications.

Jason Campagna

Second, that the doses that we're using are really the diabetic doses. They are not anticipated to have much of an effect at all. We've certainly seen that in the clinical trial data. I think to the second question about the tools, are you talking about PathAI specifically or just more general non-invasives?

Jayed Momin

Yeah, no, it's the PathAI tool.

Jason Campagna

Yeah. It's an interesting idea, right? Looking at it really simply, what PathAI lets you do is substitute one human pathologist for a digital pathologist, and then you need a second pathologist to read. It's still the same idea, two plus one consensus. In this case, one of the two is PathAI. It's interesting. It's not something that in NATiV3 we anticipate taking much advantage of, but it is something we're thinking very closely about for NATiV4, potentially even using that as the in the exploratory cohort presently for NATiV3, to see how we may be able to pull more data out of those patients that happen to have a biopsy.

Jayed Momin

Got it. Thank you so much for the answers.

Operator

Thank you. Our next question for today comes from the line of Rami Katkhuda from LifeSci Capital. Please go ahead.

Rami Katkhuda

Hi, guys. Thanks for taking my questions as well. I guess, can you remind us of lanifibranor's FC and F2 versus F3 patients in the phase II study and how those differences may impact the expectations for NATiV3, just given the higher proportion of F3 patients enrolled?

Andrew Obenshain

Good morning, Rami. Go ahead, Jason.

Jason Campagna

Rami, just to qualify, you want the proportion of patients in NATIVE2 or the responses of the F2, F3?

Rami Katkhuda

The responses, please, between the phase II's and phase III's.

Jason Campagna

The sample sizes are simply too small to break out. What we have done, we think the analysis that's more helpful, it's in our corporate materials, is that when you strip away the F1s in that trial, you get down to about 188 F2, F3 across all three arms. You can see that the effect size actually slightly goes up. What we guide to is that it remains unchanged. The drug seems to work equally well in more advanced fibrosis than patients with earlier disease. You're not getting much of a free ride on those F1s if you will. Second, when we look at NATiV3, as Andrew talked about earlier, this is a contemporary MASH market. The majority of patients showing up in clinics today that have F3 disease will have diabetes.

Jason Campagna

We think that aligns pretty well with the outside world, and we're pretty comfortable with what we've seen from our Nature publication back in 2024, that the drug not only works equally well in earlier and late stage disease, but the adiponectin levels actually go up equally well across all cohorts. It's that adiponectin that's really driving, we think, well correlated with the clinical response. We like where we're landing with NATiV3 and the likelihood of efficacy in both those F2 and F3 patients. As a reminder, we're stratified by fibrosis stage and diabetes in NATiV3. We have to cut those data a number of different ways to sort of get where you're headed with your question.

Rami Katkhuda

Makes a lot of sense. Thank you.

Operator

Thank you. Our next question comes from the line of Srikripa Devarakonda from Truist Securities. Please go ahead.

Anna Chien

Hi, this is Anna on for Srikripa. Thanks so much for taking our questions. Two questions from us. First, looking ahead a little bit in terms of the MASH guidelines, would you expect an update on the MASH guidelines this year, and how are you thinking about getting Lani into the MASH guidelines? Then second question, in terms of cash, what kind of needs to happen for you to have access to that third tranche? Is it based on kind of phase III success only? And are you looking at any other non-dilutive sources of funding, such as partnerships? Thank you.

Andrew Obenshain

Morning, Anna. Thanks for the questions. On the MASH guidelines, I think we wanna wait. We need to get data first before we have any conversations about putting lanifibranor into the MASH guidelines. On cash, the tranche three is a positive endpoint. We hit a positive endpoint in our trial, and then those 77 million shares at EUR 50 become exercisable, and the investors have 45 days to exercise them. That's how that mechanically works. Positive trial equals quickly cash coming in, so long as the stock price stays above EUR 50. We are always looking for ways to increase our cash runway. We're obviously in a very strong cash position right now.

Andrew Obenshain

In terms of partnerships, right now our plan is to commercialize lanifibranor ourselves. Going forward, we think that there's plenty of access to capital either in the equity markets, or other kind of capital sources that we don't necessarily need to partner lanifibranor.

Anna Chien

Great. Thank you so much.

Operator

Thank you. We are going to take our next question, and our next question comes from the line of Sushila Hernandez from Van Lanschot Kempen. Please go ahead.

Sushila Hernandez

Yes, thank you for taking my question. 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? Thank you.

Andrew Obenshain

Yes. Sushila Hernandez, good question, and morning. Yeah, we are being very careful stewards of our capital right now before data. The regulatory team is fully staffed, and I would include the quality team in that too, because that's necessary to make a really good filing with the FDA. We've invested. We've increased the size of that team and the talent on that team in the course of this year. From a commercial standpoint, really focused on strategic commercial execution. Being led by Nazira Amra, really focused on market access and market research. I'm gonna include in the broad commercialization medical affairs there. The strategic roles that will really set us up for success in the future.

Andrew Obenshain

We will not staff up aggressively in commercial until we have positive data.

Sushila Hernandez

That's clear. Thank you.

Operator

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

Andrew Obenshain

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

Operator

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

As of 2026-10-03 • Updated weeklySource: Earnings sourceIngestion runbook