BioCardia Q1 2023 net loss $3.5M; adaptive FDA plan for heart failure trial submitted

BioCardia, Inc.

Revenue $64K (flat YoY); net loss $3.5M vs $3.3M; cash used in ops $2.6M.
Phase III CardiAMP HF trial: adaptive statistical analysis plan submitted to FDA Apr 26; DSMB meeting late June.
Japan PMDA submission expected Q2 2023 for CardiAMP; roll-in cohort 2-yr survival 100%.
BCDA-03 allogeneic HFrEF trial first patient expected Q2 2023; BCDA-04 ARDS trial start Q4 2023.
FDA audit of quality system resulted in zero written observations.

item 2.02 item 9.01

Key facts

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Earnings Releases SEC 8-K Item 2.02 confidence 0.9

BioCardia, Inc. reported first quarter of 2023 results: revenue approximately $64 thousand.

Period: first quarter of 2023
Revenue: approximately $64 thousand
Result: reported results

Exact text from the filing

CellProthera’s next clinical study, and potential early access commercialization, which could begin in 2024. First Quarter 2023 Financial Results: > Revenues were approximately $64 thousand for the three months ended March 2023, compared for approximately $60 thousand in the three months ended March 2022. > Research and development expenses increased to a

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Source: SEC EDGAR

accession 0001437749-23-013592

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