PIPELINE

 
 
 

One Therapy. Multiple Fronts Against Serious Liver Disease

Our pipeline is currently anchored in pemvidutide*, a novel dual-action therapy engineered to target both the cause and the consequence of serious liver disease. With a single differentiated molecule, we are advancing programs across metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD), and alcohol-associated liver disease (ALD).

Our Priority Programs in Serious Liver Diseases

Pemvidutide, our dual-action lead candidate, is advancing across metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD), and alcohol-associated liver disease (ALD). In MASH, the PERFORMA Phase 3 trial, our registrational study of pemvidutide, has been initiated and is actively enrolling patients. Positive topline results from the Phase 2 RECLAIM trial support the continued development of pemvidutide for AUD, while the Phase 2 RESTORE trial in ALD remains ongoing, with a key trial readout anticipated in 2027. The U.S. Food and Drug Administration granted Fast Track designations to pemvidutide for the treatment of MASH and AUD, as well as Breakthrough Therapy Designation for MASH, underscoring both the urgency of these diseases and the potential of our investigational product.

Pemvidutide
Preclinical
Phase 1
Phase 2
Phase 3
Key Milestones
Preclinical
Phase 1
Phase 2
Phase 3
MASH
(FDA Fast Track Designation)
(FDA Breakthrough Therapy Designation)

Title

90%
Key Catalysts
4Q25: IMPACT Phase 2b 48w data
4Q25: End of Phase 2 FDA meeting complete
3Q26: Initiate PERFORMA Phase 3 trial
AUD
(FDA Fast Track Designation)

Title

60%
Key Catalysts
4Q25: RECLAIM Phase 2 trial enrollment complete
3Q26: RECLAIM topline data
ALD

Title

55%
Key Catalysts
3Q26: Enrollment complete

MASH: metabolic dysfunction-associated steatohepatitis
AUD: alcohol use disorder
ALD: alcohol-associated liver disease

*Pemvidutide is investigational and has not been approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority. Safety and efficacy have not been established. There is no guarantee that it will successfully complete clinical development or receive regulatory approval.