BioCardia, Inc. — Q2 2023 Form 10-Q
Reporting period: Quarter and six months ended June 30, 2023; filed August 9, 2023. Unaudited results. BioCardia is a clinical-stage developer of cell therapies for cardiovascular and pulmonary diseases, with delivery-system and collaboration revenue.
Financial performance
Amounts below are in millions, except per-share data. Comparisons are with the corresponding 2022 period.
| Metric | Q2 2023 | Q2 2022 | Six months 2023 | Six months 2022 |
|---|---|---|---|---|
| Revenue | $0.043 | $0.974 | $0.107 | $1.034 |
| Research and development | $2.314 | $2.304 | $4.698 | $4.490 |
| Selling, general and administrative | $1.181 | $1.166 | $2.371 | $2.367 |
| Operating loss | $(3.452) | $(2.496) | $(6.962) | $(5.823) |
| Net loss | $(3.424) | $(2.497) | $(6.925) | $(5.822) |
| Basic and diluted loss per share | $(0.17) | $(0.14) | $(0.34) | $(0.34) |
| Cash used in operating activities | Not separately presented for quarter | $(5.711) | $(5.558) |
Revenue was almost entirely collaboration revenue; product revenue was zero in Q2 and the first half of 2023. Management attributed the decline to timing of partner activities and completion of collaboration deliverables. Gross profit and gross margin are not clearly presented in the filing. R&D costs rose modestly, primarily from CardiAMP heart-failure trial support.
Liquidity, capital and balance sheet
- Cash and cash equivalents were $4.305 million at June 30, down from $7.363 million at year-end 2022. Current assets were $4.650 million and current liabilities $3.616 million.
- Management said available cash would not fund planned expenditures and obligations beyond Q4 2023 without additional funding. The filing states there is substantial doubt about the company’s ability to continue as a going concern within one year after issuance.
- Six-month financing cash inflow was $2.665 million, principally from equity sales. A June registered direct offering raised approximately $2.6 million gross ($2.470 million net); ATM sales also generated proceeds. Further equity financing could dilute shareholders.
- Total liabilities were $4.754 million, including $1.478 million in operating lease liabilities. The filing reports no material off-balance-sheet arrangements and does not identify outstanding borrowings in the balance sheet.
Material developments, outlook and risks
- CardiAMP heart-failure trial: In July 2023, after reviewing interim data, the DSMB recommended pausing enrollment of new patients pending one-year follow-up outcomes for enrolled patients; it recommended continuing treatment of patients already enrolled and preserving the blind. The DSMB’s initial analysis indicated the trial was unlikely to meet its primary composite endpoint, though the company later supplied additional analyses and information. Final follow-up results were not yet available. This development may delay approval and increase costs.
- Other programs: The CardiAMP chronic myocardial ischemia trial had treated three patients at two sites; management aimed to complete its five-patient roll-in cohort in Q4 2023. BioCardia expected to begin enrollment in its allogeneic CardiALLO heart-failure study in Q3 2023. Its ARDS program was deprioritized to conserve resources.
- The company completed a CardiAMP submission to Japan’s PMDA for consultation on the HFrEF indication; further regulatory interactions were expected. Management said both CardiAMP pivotal trials qualify for Medicare coverage up to $20,000 per patient.
- Management planned to seek additional capital through potential collaboration or licensing arrangements, debt, equity, or a combination. If funding is unavailable, it may cut expenses, delay or reduce development, relinquish rights, or cease operations. The filing provides no specific financial guidance.
- Other risks include clinical and regulatory uncertainty, slow trial enrollment, dependence on external funding, and possible COVID-related disruption. The company also disclosed that it had not held its 2023 annual stockholder meeting by the July 10 deadline under Delaware law, creating potential litigation risk.
Important facts for investors to verify
- Timing and outcome of the CardiAMP DSMB follow-up review, and whether enrollment resumes.
- Ability to secure financing before the stated cash runway expires, including expected dilution or financing terms.
- Actual enrollment and milestones for the chronic ischemia and CardiALLO trials, and timing of PMDA consultation.
- Whether the annual stockholder meeting has been held and whether any related litigation has arisen.