Altimmune (ALT) Guggenheim SMID Cap Biotech Conference summary

Pipeline and clinical progress

• Lead asset pemvidutide is a GLP-1/glucagon dual receptor agonist in development for obesity and MASH, with a successful Phase II obesity study and an ongoing Phase IIb MASH trial expected to read out in Q2.

• Enrollment for the biopsy-driven Phase IIb MASH study is complete, and additional indications for pemvidutide are being explored, with at least one new IND filed at the end of last year.

• The MOMENTUM Phase II obesity study showed 15.6% weight loss at 48 weeks, significant reductions in LDL cholesterol, normalization of liver fat in 80% of subjects, and class-leading preservation of lean mass.

• A sub-study using MRI confirmed profound reductions in visceral fat and preservation of lean mass, both key for cardiovascular risk reduction.

• No safety signals were identified in the end-of-Phase II meeting with the FDA, including in diabetic patients.

Differentiation and mechanism of action

• Pemvidutide's dual agonism targets both appetite suppression and metabolic effects, including potent liver fat reduction and serum lipid improvements, due to glucagon receptor activity in the liver.

• The molecule is designed for a high glucagon:GLP-1 ratio, maximizing glucagon's benefits while maintaining glucose homeostasis.

• Class-leading preservation of lean mass is expected to support long-term weight loss maintenance.

• Pemvidutide is positioned as a complete solution for MASH, offering both antifibrotic effects and significant weight loss, unlike current single-mechanism therapies.

MASH and obesity market opportunities

• MASH patients require both fibrosis reduction and weight loss; current drugs typically address only one aspect.

• Pemvidutide demonstrated 76% liver fat reduction at 24 weeks, outperforming FGF21s and other competitors.

• The upcoming Phase IIb MASH trial is powered for both MASH resolution and fibrosis improvement, with a 24-week readout expected to be the first of its kind among incretins.

• Weight loss is a major driver for patient enrollment and future prescriptions in MASH.