Sep 28, 2026 earnings call — lanifibranor phase III readout and launch prep
Inventiva expects NATiV3 top-line readout in Q4 2026, with the main cohort of 1,009 biopsy-confirmed F2/F3 MASH patients.
Revenue $0.0B (est $0.0B) · EPS $-0.28 (est $-0.20)
Key quotes
"We remain on track to report top-line data in the fourth quarter of 2026."
"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."
"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."
Analyst Q&A 11
two dose commercial decision
Q (Yasmeen Rahimi · Piper Sandler): Analyst asked if it makes sense to advance both NATiV3 doses commercially and why histology and noninvasive tests (NITs) seemed different between doses.
A: Management said if both doses are statistically positive, both could be brought to market depending on efficacy and tolerability. They said one dose might suit earlier-stage patients and decisions depend on the actual data. They passed the technical correlation question to the clinical lead.
"First, if both doses are statistically significant positive, I think it would make sense to bring both forward in the market." — Andrew Obenshain (CEO)
weight gain and edema in phase III
Q (Seamus Fernandez · Guggenheim): Analyst asked what blinded data exist on weight gain and edema in NATiV3 and whether these effects affect patient willingness to stay on drug.
A: Management said earlier trials showed weight gain similar up to six months and then plateaued around week 24 to week 30 through week 48. They said in NATIVE about half of patients had no meaningful weight change and only about 10% of adverse event reports related to weight gain, so it did not drive discontinuations.
"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." — Jason Campagna (PRESIDENT)
edema severity and tolerability
Q (Ritu Baral · TD Cowen): Analyst asked how severe edema is, whether it is transient, and whether it becomes unacceptable to patients or clinicians.
A: Management said edema is a known on-target PPAR gamma effect and clinicians familiar with pioglitazone can manage it. They reported 7%-10% unadjusted edema in NATIVE II and about 2% drug-related edema, generally mild to moderate and not a main cause of discontinuation.
"Edema, as Andrew mentioned, is a known on-target consequence of PPAR gamma." — Jason Campagna (PRESIDENT)
protocol management and rollovers
Q (Thomas Smith · Leerink Partners): Analyst asked if the protocol includes counseling or management for weight gain/edema and how many patients rolled into active extension; also asked about patient population estimates.
A: Management said they have not disclosed active-extension rollover numbers. They said there is no formal management algorithm in NATiV3, but investigators are educated and may use diuretics or SGLT2s to manage fluid retention. They noted their 374,000 F2/F3 specialist-treated patient estimate is on the low end of published ranges and the population is sizable and evolving.
"There's no formal management algorithm or treatment algorithm in the NATiV3 protocol." — Jason Campagna (PRESIDENT)
F2 vs F3 mix and GLP-1 drop-ins
Q (Kyle Yang · UBS): Analyst asked how a higher F3 share versus phase II affects efficacy/placebo and how 9% GLP-1 drop-ins might affect outcomes.
A: Management said more F3s reflected more U.S. and more diabetic patients but biology is the same between F2 and F3 and lanifibranor acts directly on liver stellate cells. They said the 9% GLP-1 drop-ins were on lower, non-MASH doses and are not expected to impact the trial.
"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." — Jason Campagna (PRESIDENT)
launch funding and cash runway
Q (Annabel Samimy · Stifel): Analyst asked how the company is preparing for launch funding and what cash runway exists after recent financing.
A: Management said the June capital transaction funds the company through end of Q2 2027 and adding structured financing tranches could extend runway to start of Q1 2028. They said this funding supports the upcoming data readout and an NDA filing, but they are not guiding on future raises.
"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." — Axel-Sven Malkomes (CFO)
interim blinded weight data
Q (Prakhar Agrawal · Cantor): Analyst asked why an earlier blinded interim weight dataset should or should not be used to predict final weight results.
A: Management clarified the earlier look was not an interim read but an early look at ~100 blinded patients who reached week 72 and that reusing blinded data from a 1,000+ trial is risky and not helpful. They said they are not guiding on repeating such blinded disclosures.
"It was an early look at approximately 100 blinded patients that have achieved week 72." — Jason Campagna (PRESIDENT)
what proves antifibrotic effect
Q (Kripa Devarakonda · Truist): Analyst asked what level of fibrosis response would convince management lanifibranor is truly antifibrotic versus metabolic/inflammatory.
A: Management said an 18% one-stage fibrosis improvement is meaningful and would replicate their phase II result into phase III. They said that level would be differentiated especially in F3 diabetics, F3 non-diabetics, and F2 diabetics.
"We believe 18% improvement is meaningful in fibrosis to basically duplicating our phase II into phase III." — Andrew Obenshain (CEO)
confirmatory outcomes trial design
Q (Rami Katkhuda · LifeSci Capital): Analyst asked about timing of weight gain components and how the outcomes trial will be designed and informed by existing data.
A: Management said they will focus confirmatory trials on chronic advanced compensated liver disease patients with clinically significant portal hypertension and can identify them with noninvasive tests. They noted an exploratory cohort of ~75 to 100 cirrhotic patients exposed to lanifibranor for at least 18 months and prior phase I hepatic impairment studies will help design a strong outcomes trial.
"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" — Jason Campagna (PRESIDENT)
top-line contents and placebo rate
Q (Sushila Hernandez · Van Lanschot Kempen): Analyst asked what will be included in the upcoming top-line release (GLP-1/SGLT2 subgroup data, weight gain) and how placebo response may change with 18 months.
A: Management said they are not guiding on what will be in the top-line readout but expect to address many of these questions at that time. They added the composite primary endpoint was chosen to better control for placebo response, and they would not speculate on exact placebo rates.
"We are not guiding on the top-line data right now." — Andrew Obenshain (CEO)
GLP-1 baseline subgroup analysis
Q (Jason Zhang · Wolfe): Analyst asked if baseline GLP-1 subgroup is large enough to assess incremental histology benefit and how sensitivity analysis would be shown.
A: Management clarified GLP-1 drop-ins were at lower, non-MASH doses and they do not expect a histological effect from those GLP-1s. They said sensitivity analyses for drop-ins are pre-specified and standard in phase III trials to separate lanifibranor effect from other therapies.
"First of all, clarification, the GLP-1s drop-ins that were allowed in the trial were not at the MASH dose." — Andrew Obenshain (CEO)