BCDA · BioCardia, Inc.
Substantial doubt about the company's ability to continue as a going concern.
“These factors raise substantial doubt about our ability to continue as a going concern beyond one year from the date these financial statements are issued. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. Our ability to continue as a going concern and to continue further development of our therapeutic candidates beyond January 2027 will require us to raise additional capital, possibly through licensing certain product rights. We plan to raise additional capital, potentially including non-dilutive collaboration and licensing arrangements, debt or equity financing, or a combination from these sources to finance our future operations. While management believes this plan to raise additional funds will alleviate the conditions that raise substantial doubt, these plans are not entirely within their control and cannot be assessed as being probable of occurring.”View the 10-Q filed Aug 12, 2026
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AI Brief
Q2 FY26 earnings call · Aug 12, 2026TL;DR. BioCardia reported three positive regulatory interactions in Q2: Japan PMDA supports a Shonin submission of CardiAMP cell therapy targeted for Q4 2026, FDA confirmed the ongoing CardiAMP HF II trial may be sufficient for PMA approval, and FDA indicated Helix delivery catheter DeNovo approval is possible. Net loss narrowed to $1.6M on lower R&D, and the company ended the quarter with $4.1M in cash (runway into 2027) after raising $4.9M under its ATM facility.
- + Japan PMDA supports advancing CardiAMP cell therapy to Shonin pre-market submission targeted for Q4 2026.
- + FDA confirmed the ongoing CardiAMP HF II trial may support pre-market approval, signaling a single trial could be sufficient for U.S. approval.
- + FDA indicated DeNovo approval of the Helix transendocardial delivery catheter is possible, with no safety, device performance, or compatibility concerns raised.
- + Company raised approximately $4.9M net proceeds under its ATM facility at an average of $1.22 per share, with no warrants or dilutive securities issued.
- + Cash and cash equivalents of $4.1M (per 8-K) provides runway into 2027 and the company believes it is compliant with NASDAQ listing standards.
- − The CardiAMP HF II confirmatory trial is enrolling slowly, with only four sites active and management characterizing the rate as not 'blazing speeds.'
- − FDA is still pushing back on the quality-of-life tier of the trial's composite outcome measure, creating uncertainty around the primary endpoint.
- − Helix DeNovo formal FDA meeting minutes are delayed beyond the June 12 expected date, leaving regulatory pathway details unconfirmed.
AI-generated from the earnings call and 8-K · may contain errors · not investment advice
Equibles Rating
blended score · not investment adviceBlended from price, momentum, positioning, fundamentals & volatility · daily-close · not investment advice. Market backdrop is context, not part of the score.
Technicals
trend & momentum for long-term holders NeutralIllustrative technical + ownership context — a signal mix, not investment advice.
Key metrics
Earlier KPI extraction records exist, but do not meet the current evidence-completeness requirements. No current verified series is available. Earlier figures remain withheld until revalidated; this is not evidence that the company reports no KPIs.
Versus peers
Biotechnology — same industry group| Company | Mkt cap | YTD | Rev growth Y/Y | P/E | Short % shares |
|---|---|---|---|---|---|
|
BCDA
this stock
BioCardia, Inc.
|
$16.35M | -13.6% | -16.8% | — | 6.7% |
|
VRTX
Vertex Pharmaceuticals Inc / Ma
|
$130.64B | +13.7% | +46.2% | 30.0 | 1.8% |
|
REGN
Regeneron Pharmaceuticals, Inc.
|
$80.46B | +1.2% | +20.8% | 19.4 | 2.5% |
|
ARGX
Argenx SE
|
$61.22B | +17.1% | — | — | 2.0% |
|
MRNA
Moderna, Inc.
|
$57.48B | +388.2% | +4.3% | — | 9.8% |
Peers by industry group · P/E from as-reported trailing EPS · short % is of shares outstanding
At a glance
key data from every sectionPerformance
Raw-price comparisons begin at the captured split on May 30, 2024; windows that need an earlier baseline remain unavailable.
| 5D | 20D | 120D | MTD | YTD | |
|---|---|---|---|---|---|
| BCDA | -0.9% | +16.1% | -10.0% | -5.3% | -13.6% |
| SPY | -1.2% | -1.8% | +17.8% | -0.4% | +12.1% |
| vs SPY | +0.2% | +17.9% | -27.8% | -4.9% | -25.7% |