secwatch.observer — SEC 8-K summary
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Issuer:     BioCardia, Inc. (BCDA)
CIK:        0000925741
Form:       8-K
Filed at:   2022-11-09T23:59:59+00:00
Accession:  0001437749-22-026593
Event type: earnings
Sentiment:  positive
Materiality: 0.65
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

BioCardia reports Q3 net loss $8.9M, DSMB supports adaptive design for heart failure trial
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- 9-month revenue $1.2M (up from $0.9M), net loss $8.9M, operating cash burn $7.6M.
- CardiAMP heart failure trial DSMB recommends adaptive statistical plan for early readout; 100% survival at 2 years in roll-in cohort.
- IND filed for NK1R+ MSC for heart failure (BCDA-03); FDA approval anticipated Dec 2022.
- First manufacturing batch for ARDS program (BCDA-04) completed; first patient treatment expected Q4 2022.
- BlueRock partnership for cell delivery; upfront payment received, option for worldwide license.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/925741/000143774922026593/0001437749-22-026593-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/925741/000143774922026593/bcda20221108_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-22-026593

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer