As Inventiva continues to enroll patients into its Phase 3 liver disease program, it is seeking new funding to replenish its dwindling cash runway.
The biotech had just €9.6 million ($10.4 million) in cash and equivalents at the end of May, which is estimated to be enough to support Inventiva’s operations through the second half of this month, according to a Friday release.
The company said it is working to complete a royalty-based financing that would extend its runway through the summer. But even if this is successful, it still needs to find a long-term solution.
The registrational trial of lanifibranor in metabolic dysfunction-associated steatohepatitis (MASH) is not due to read out until the second half of 2026.
Inventiva has enrolled more than 80% of its 950 targets for the primary cohort of the placebo-controlled NATiV3 trial, with an additional 165 patients expected to be recruited. The trial has exceeded its target enrollment of 200 participants in the exploratory cohort.
In February, the company’s shares $IVA plummeted by 20% after a serious adverse event triggered a pause in study enrollment, although this has since been lifted.
Inventiva’s last major financing was in August 2023, when it clinched around €35.7 million ($38.7 million) from both new and existing investors. In 2018, it raised $44 million in preparation for its Phase 3 program.
But other, more recent attempts to secure cash through “the issuance of debt, equity and other instruments” have been unsuccessful, the company said.
A long-term solution could range “from partnerships to outright sale,” Stifel analysts said in a Sunday note. But finding a partner interested in MASH could be challenging given the recent “downstream evidence” of Eli Lilly’s dual GLP-1/GIP receptor agonist tirzepatide achieving MASH resolution with fibrosis data, they added.
Unlike incretin-based approaches, oral lanifibranor activates all three isoforms of the peroxisome proliferator-activated receptor. The drug has the potential to address the broad spectrum of MASH by bringing about vascular and metabolic improvements while also triggering anti-inflammatory and antifibrotic effects, according to Inventiva.
Inventiva’s NATiV3 study is evaluating 800 mg and 1,200 mg doses of lanifibranor in adults with biopsy-proven non-cirrhotic MASH and stage 2 or 3 fibrosis.
The only drug currently approved for MASH is Madrigal Pharmaceuticals’ thyroid hormone receptor beta agonist Rezdiffra, which was greenlit in the US in March. The product could reach $3.4 billion in sales across the US and Europe, Jefferies analysts wrote in May. Madrigal is set to report Rezdiffra sales for the first time in its next earnings report.