Inventiva Q2 Earnings Call Highlights

Key Points

• 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.

Phase III readout approaches

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.

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.

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.

Safety, dosing and concurrent therapies discussed

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.

Plans extend to advanced liver disease

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.

Financing supports milestones through potential filing

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.

About Inventiva (NASDAQ:IVA)

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 contact@marketbeat.com.