BioCardia, Inc. — FY 2023 Form 10-K
Reporting period: Fiscal year ended December 31, 2023. Filed March 27, 2024. BioCardia is a clinical-stage cardiovascular and pulmonary cell-therapy company; its principal programs are investigational. It also sells certain cleared catheter and delivery products and earns collaboration revenue.
Financial performance and liquidity
| Metric | 2023 | 2022 |
|---|---|---|
| Revenue | $477,000 | $1.352 million |
| Research and development | $7.726 million | $8.834 million |
| Selling, general and administrative | $4.395 million | $4.419 million |
| Operating loss | $11.644 million | $11.901 million |
| Net loss | $11.571 million | $11.907 million |
| Net loss per share | $0.55 | $0.67 |
| Cash used in operations | $9.974 million | $10.561 million |
| Cash and cash equivalents, year-end | $1.103 million | $7.363 million |
Revenue was almost entirely collaboration revenue; product revenue was zero in 2023 versus $3,000 in 2022. The company attributed the revenue decline to partner timing and completed deliverables. Lower R&D spending, including reduced clinical personnel costs and the pause/completion of enrollment in CardiAMP HF, contributed to a slightly smaller net loss. Gross margin was not separately presented.
At year-end, total assets were $2.987 million, total liabilities $4.590 million, and stockholders’ deficit $1.603 million. Current assets were $1.461 million against current liabilities of $3.608 million. Lease liabilities totaled $1.315 million; the filing does not report other borrowings as outstanding. Financing activities provided $3.726 million in 2023, primarily from common-stock sales. The company had an accumulated deficit of $152.2 million.
Management and the auditor identified substantial doubt about the company’s ability to continue as a going concern. Management said year-end cash was insufficient to fund planned expenditures and obligations beyond Q2 2024 without additional funding. As of March 27, 2024, cash was approximately $1.0 million, also expected to be insufficient beyond Q2 2024. The auditor issued an unqualified opinion on the financial statements, with a separate going-concern emphasis.
Material developments, outlook, and risks
- CardiAMP HF Phase III: Enrollment was completed in October 2023. In July 2023, the monitoring board concluded the trial was unlikely to meet its 12-month primary efficacy endpoint, in part because improvement in six-minute walk distance in both arms heavily influenced the composite endpoint. Interim results presented in March 2024 reported favorable trends in certain outcomes, including fewer cardiac death equivalents; these interim findings do not change the reported primary-endpoint concern. Final follow-up data were expected in Q4 2024.
- Further clinical development: FDA approved the CardiAMP HF II Phase III trial in Q4 2023; it was activated in Q1 2024, with enrollment targeted for completion in two years. The CardiAMP chronic myocardial ischemia trial was active at two sites, with randomized enrollment expected to begin. CardiALLO allogeneic MSC development was in an early Phase I/II study; the ARDS program had no 2024 milestones set.
- Funding and dilution: The company expects continued losses and needs additional capital through equity or debt, collaborations, licensing, or other sources. It warned financing may not be available or may be highly dilutive. A February 2024 private placement raised approximately $875,000 gross through stock and warrant sales. The HCW at-the-market agreement permits up to $2.75 million in sales, but the filing notes approximately $2.2 million was then covered by an effective registration statement and sales are not assured.
- Nasdaq listing: In March 2024, BioCardia disclosed that it had not regained compliance with Nasdaq’s minimum market-value and bid-price requirements. It appealed the delisting determinations; the appeal stayed suspension pending the hearing panel’s decision. Delisting could impair trading and access to capital.
- Commercial and regulatory uncertainty: No cell-based therapy for a cardiac indication had been FDA-approved in the United States, and CardiAMP approval depends on clinical evidence and regulatory review. Companion diagnostic approval, manufacturing scale-up, reimbursement, market acceptance, and competition remain material uncertainties. Medicare coverage of specified trials reduces trial costs but is not product approval or a guarantee of future commercial reimbursement.
- Other matters: Revenue is concentrated: two customers represented approximately 71% and 21% of 2023 revenue. The company reported no pending legal proceedings management believed likely to have an adverse effect, no off-balance-sheet arrangements, and no material cybersecurity impact to date. Cash was concentrated at one financial institution, with approximately $0.8 million above FDIC insurance limits.
Key facts for investors to verify
- Current cash, cash burn, financing availability, and the company’s ability to fund operations beyond Q2 2024.
- The Nasdaq hearing outcome and current listing status, including subsequent equity and warrant issuance and resulting dilution.
- Final CardiAMP HF results, especially the primary endpoint, follow-up completeness, and whether interim subgroup findings are confirmed.
- Enrollment, timing, funding, and regulatory requirements for CardiAMP HF II, CardiAMP CMI, and CardiALLO.
- Whether collaboration revenue recovers and how customer concentration affects future revenue and cash receipts.
- Any changes to the going-concern assessment, clinical timelines, manufacturing readiness, or regulatory pathway since the filing date.