1Q26: Pivotal Ph3 TRD GH001 Program To Start In Late 2026 After FDA Alignment

研报英文原文证据摘录

1Q26: Pivotal Ph3 TRD GH001 Program To Start In Late 2026 After FDA Alignment

TD Cowen GH Research

Global Research May 14, 2026

AT A GLANCE

Our Investment Thesis Forthcoming Catalysts

GH Research is currently studying their candidate GH001 (a formulation of 5-MeO-DMT) for Late 2026: Ph3 TRD program start of GH001

use in TRD. We view the rapid onset of effect and short duration of the psychedelic experience

as a key potential commercial advantage for GH001 relative to some other psychedelic

therapies in development. GHRS generated impressive topline Ph2b TRD data in which GH001

showed a statistically significant -15.5 MADRS decrease vs PBO on day 8 (p<0.00001), and

57.5% of patients were in remission on day 8 vs PBO (p<0.0001). '001's safety profile thus

far appears markedly more favorable than Spravato, which has important implications for

its safety monitoring strategy, potentially driving a less onerous and time-consuming REMs

than Spravato. This could represent a significant feasibility advantage and increased patient

convenience vs Spravato without compromising efficacy.

Base Case Assumptions Upside Scenario Downside Scenario

■ GH001 proves to generate promising ■ GH001 is able to gain approval for the ■ GH001 fails in clinical studies for TRD

clinical efficacy data, with good safety treatment of TRD based on compelling ■ GHRS needs more capital than

showing improvement efficacy anticipated, diluting shareholders

■ GH001 is able to gain approval for the ■ GH001 reaches the market with Centers

treatment of TRD of Excellence successfully established to

drive adoption

Price Performance Company Description

GH Research is currently studying their lead candidate GH001 (a formulation of 5-MeO-DMT) for

$24