Mgmt Meeting: Confidence High Ahead of Ph3 MASH Topline in 4Q26

研报英文原文证据摘录

Mgmt Meeting: Confidence High Ahead of Ph3 MASH Topline in 4Q26

etic MASH, followed by F2 diabetic,

F3 non-diabetic, and then F2 non-diabetic patients. IVA previously estimated ~375K diagnosed

F2/F3 MASH patients in the U.S., with 50%+ of these being diabetic. In our meeting, mgmt

expanded the addressable population to ~375K-450K US F2/F3 patients, with the increase due

to the growing MASH awareness and increasing diagnosis rate. Diabetic F3 patients represents

the clearest opportunity to IVA given the high progression risk, metabolic comorbidity, and a

relatively easier risk/benefit discussion around any modest fluid-related weight gain.

We see this segmentation as important for commercial launch framing. Lani’ may be a less

compelling treatment option initially in lower-risk F2 non-diabetics, where patient tolerance of

non-medical edema is higher and urgency to treat is lower. However, if NATiV3 efficacy looks

materially stronger than current approved therapies, especially in fibrosis improvement, mgmt

believes F2 non-diabetics could also become an amenable population for lani'.

Preparation for Phase 3 F4 Outcomes Trial Ongoing

Mgmt confirmed that, per FDA guidance, a MASH outcomes study must be initiated prior to

NDA filing (expected 2027), consistent with expectations for accelerated approval in MASH.

The planned study will focus on high-risk F3/F4 patients with portal hypertension. IVA believes

this population will drive enough outcome events to power the study, while patients are early

enough in their disease to still retain potential to benefit from disease-modifying therapy. Mgmt

indicated protocol work, CRO activity, and site activation/screening are underway. Importantly,

first-patient enrollment is not required prior to filing.

2 TDSecurities.com