Aug. 19 at 4:59 PM
$ALT So
$IVA’s filings provide a good real-world benchmark for what a large biopsy-driven MASH Phase 3 costs today.
Inventiva began NATiV3 in 2021. Its disclosed lanifibranor-specific external research/clinical spend was roughly (from 10ks):
2021: €31M
2022: €40M
2023: €86M
2024: €68M
2025: €66M
That’s ~€291M through 2025, although that includes some lani costs outside NATiV3. IVA also disclosed unusually high screen-failure rates and enrollment delays early in NATiV3.
How does that translate to ALT?
PERFORMA has 990 in the biopsy cohort (another ~800 are enrolled using NITs). Of note, ALT will use PathAI AIM-MASH AI Assist, which the data in the FDA approval package (using the ESSENCE trial from NVO in MASH) showed that PathAI would reduce understaging/screen fails. This permits a single AI-assisted central pathologist for enrollment and endpoint reads rather than traditional multi-reader consensus. It will enrollment more efficient.
Add two other changes in hte field since NATiV3 started:
• pathology competition has pushed biopsy-reading costs down somewhat
• better pre-screening/NIT enrichment + PathAI should reduce wasted screening biopsies and histology-related screen failures
So simply applying NATiV3’s historical cost/patient to PERFORMA probably overstates ALT’s cost.
My rough estimate is ~
$240–300M to the 52-week PERFORMA readout, with ~
$275–285M a reasonable midpoint.
Against ALT’s ~
$519M cash, that leaves room for commercialization, AUD/ALD p3 and possible oral program.
