BCDA (BioCardia Inc.) stock: $0.85, $12.9M market cap, $4.1M cash, $8.8M EV, $20.2M fully diluted market cap. Next expected readout: Nov-26. Lead program: CardiALLO™ Human Allogenic Culture-expanded Bone marrow-derived Mesenchymal Stem (Heart Failure, Systolic), Phase 2. Data from Fully Diluted's biotech stocks database.
What they do
BioCardia is a developer of cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, using its biotherapeutic delivery systems including the Helix transendocardial delivery system and Morph vascular delivery platform to advance autologous and allogeneic cell therapies in clinical trials.
Estimated readout windows: registry primary-completion date + 6-12 weeks. Windows already open are shown from "Now". Drug names link to ClinicalTrials.gov.
Partnerships CART-Tech B.V.: Heart3D development/license/distribution partner (BioCardia holds exclusive biotherapeutic-delivery licenses and distribution rights worldwide; cardiac biopsy rights in US)
Indications
Ischemic heart failure with reduced ejection fraction (HFrEF)(Phase 3)
Chronic myocardial ischemia with refractory angina(Phase 3)
Status note Confirmatory CardiAMP HF II trial enrolling. May 2026 PMDA Consultation Record supports a Japan approval submission based on three completed trials. FDA Q-Sub (June 2026) confirms ongoing HF II may support PMA. Breakthrough Device Designation January 2022.
Status note IND approved; 3+3 roll-in dose-escalation plus 360-patient randomized controlled study per IND amendment; low-dose (20M cells) cohort completed, DSMB recommended proceeding. Seeking non-dilutive/partnering funding.
Status note IND approved 2022 for ARDS caused by COVID-19; not yet advanced into clinic; seeking partnering; no milestones set for 2026.
Helix biotherapeutic delivery system
Stage not disclosed · ActiveModality: transendocardial delivery catheter system
Partnerships Selectively partnered for biotherapeutic delivery with revenue sharing; CART-Tech B.V. (Heart3D imaging enhancement)
Indications
Intramyocardial therapeutic/diagnostic agent delivery(Stage not disclosed)
Status note FDA pre-submission under Q-Submission program; May 2026 meeting agreed two pathways to marketing clearance, preferred route simultaneous with CardiAMP HF approval, with a follow-on DeNovo option. Safety data from 15 clinical trials.
Status note FDA market clearance received (8 French equivalent for transseptal cardiac procedures under name AVANCE; Morph-DNA family cleared across diameters/lengths); generates modest product revenue.
Per-asset detail extracted from the 10-Q filed 2026-08-12. Fields the filing does not state are marked "not disclosed" rather than filled from other sources.
Pipeline
Lead drug
CardiALLO™ Human Allogenic Culture-expanded Bone marrow-derived Mesenchymal Stem
Sponsor-matched active trials from ClinicalTrials.gov (3 as sponsor, 0 as collaborator); "Sponsor" = company is the lead sponsor, "Collaborator" = company is a collaborator. The BP column flags big-pharma involvement as lead sponsor or collaborator (excluding the company itself). The Mgmt guide column shows what management guided for readout timing when a guided program matches the trial (hover for the quote, click for the source). Trial listings are not a company pipeline slide.