Fractyl Health Q4 2023: FDA approves IDE for Revita weight-maintenance study; gene therapy candidate RJVA-001 nominated

FRACTYL HEALTH, INC.

2024-Q1 EPS reported -$0.17 revenue$33,000

FDA IDE approval for Revita Remain-1 pivotal study for weight maintenance in obesity patients after GLP-1 discontinuation; enrollment expected H2 2024.
Enrollment in Revitalize-1 T2D pivotal study expected to complete Q2 2024; topline data Q4 2024.
Announced RJVA-001 as first GLP-1 pancreatic gene therapy candidate; IND-enabling studies to complete H2 2024.
Completed IPO raising ~$100.3M net; cash on hand expected to fund operations through 2025.
FY 2023 net loss $77.1M vs $46.5M in 2022; revenue insignificant $0.1M; R&D expense $38.0M.

item 2.02 item 9.01

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Earnings Releases SEC 8-K Item 2.02 confidence 0.9

FRACTYL HEALTH, INC. reported financial results for quarter and year ended December 31, 2023.

Period: quarter and year ended December 31, 2023
Result: reported results

Exact text from the filing

On April 1, 2024, Fractyl Health, Inc. announced its financial results for the quarter and year ended December 31, 2023 and provided a corporate update.

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Source: SEC EDGAR

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