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.
Company narrows focus to lanifibranor and NATiV3
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.
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.
Clinical rationale and trial design details
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.
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.
Management discusses dropouts, dosing, biopsies, and safety monitoring
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.
Market positioning, diabetes overlap, and potential next steps
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.
Financial position, odiparcil divestiture, and runway guidance
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.
About Inventiva (NASDAQ:IVA)
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.
