BioCardia pauses BCDA-01 heart failure trial after DSMB says likely to miss primary endpoint

BioCardia, Inc.

DSMB recommended pause in BCDA-01 Phase III trial for ischemic heart failure after review shows unlikely to meet FS composite endpoint; no safety issues.
Q2 2023 revenue $43K, down from $974K YoY; net loss $3.4M vs $2.5M; net cash used in ops $3.2M vs $2.6M.
BCDA-02 chronic myocardial ischemia trial expects roll-in cohort completion Q4 2023; BCDA-03 allogeneic trial expects first patient Q3 2023.
Japan PMDA formal consultation for BCDA-01 accepted; Helix platform patent granted in Japan and European intention to grant.

item 2.02 item 9.01

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Earnings Releases SEC 8-K Item 2.02 confidence 0.9

BioCardia, Inc. reported financial results for second quarter of 2023.

Period: second quarter of 2023
Result: reported results

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today reports financial results for the second quarter of 2023

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Source: SEC EDGAR

accession 0001437749-23-022787

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