BioCardia, Inc. — Q3 2023 Form 10-Q
Reporting period: Quarter and nine months ended September 30, 2023. Financial statements are unaudited; monetary amounts below are in millions of dollars unless stated otherwise.
Business context
BioCardia is a clinical-stage company developing bone-marrow-derived cell therapies for cardiovascular and pulmonary diseases. Its programs include autologous CardiAMP therapies for ischemic heart failure and chronic myocardial ischemia, allogeneic NK1R+ cell therapies for heart failure and acute respiratory distress syndrome (ARDS), and the Helix heart-delivery platform. The company has devoted substantially all resources to research and development and reports one operating segment.
Financial performance and liquidity
| Metric | Q3 2023 | Q3 2022 | Nine months 2023 | Nine months 2022 |
|---|---|---|---|---|
| Total revenue | $0.357 | $0.212 | $0.464 | $1.246 |
| Research and development | $1.872 | $2.144 | $6.570 | $6.634 |
| Selling, general and administrative | $1.083 | $1.128 | $3.454 | $3.495 |
| Operating loss | $(2.598) | $(3.060) | $(9.560) | $(8.883) |
| Net loss | $(2.574) | $(3.057) | $(9.499) | $(8.879) |
| Net loss per share | $(0.12) | $(0.17) | $(0.46) | $(0.51) |
| Operating cash used | — | — | $(8.123) | $(7.564) |
Revenue was collaboration-agreement revenue except for immaterial product sales in 2022; no product revenue was reported in 2023. The filing does not present gross profit or gross margin. Collaboration revenue can vary substantially with partners’ activities and deliverables.
At September 30, 2023, cash and cash equivalents were $1.835 million, down from $7.363 million at December 31, 2022. Current assets were $2.116 million versus current liabilities of $3.330 million; total liabilities were $4.407 million. The balance sheet reports no conventional debt balance; operating lease liabilities totaled $1.398 million. Stockholders’ equity was a deficit of $0.660 million, compared with positive equity of $4.892 million at year-end 2022. Accumulated deficit was $150.1 million.
For the first nine months, investing cash use was $0.012 million and financing cash provided was $2.607 million, primarily from stock sales. The company raised approximately $2.6 million gross in a June 2023 registered offering and received net proceeds from ATM sales. Shares outstanding increased from 20.08 million at year-end 2022 to 21.62 million at September 30, 2023.
Changes versus prior comparable periods
- Third-quarter revenue increased 68% year over year, while nine-month revenue declined 63%, primarily due to timing and completion of collaboration deliverables.
- Third-quarter net loss narrowed to $2.574 million from $3.057 million; nine-month net loss widened to $9.499 million from $8.879 million.
- R&D expenses declined in both comparisons, with management attributing the quarterly decrease partly to the CardiAMP heart-failure trial pause and lower clinical-support personnel costs. SG&A decreased modestly.
- Nine-month operating cash use increased to $8.123 million from $7.564 million, and cash fell by $5.528 million during the 2023 period.
Outlook, developments, and risks
- Going concern and funding: Management says the $1.8 million cash balance is insufficient to fund planned spending and obligations beyond January 2024. The company expects continuing losses and negative operating cash flows and says substantial doubt exists about its ability to continue as a going concern within one year after issuance of the statements. It plans to seek additional capital through equity, debt, collaborations, licensing, or other sources, and has reduced operating expenses. Funding is not assured; absent adequate funds, it may further cut or delay programs, relinquish rights, or cease operations.
- CardiAMP heart-failure trial: In July 2023, the DSMB recommended pausing enrollment pending one-year follow-up and outcome analysis, citing the primary endpoint assessment rather than an emergent safety issue. Management agreed that the current design was unlikely to meet its primary endpoint. The filing reports favorable interim findings, including stronger signals in a subgroup with baseline NT-proBNP above 500 pg/ml; these are interim analyses, not confirmatory trial results. Enrollment was completed in October 2023, after quarter-end. The company submitted a proposed follow-on trial protocol to FDA review, but advancement and approval are not assured.
- Other programs: The CardiAMP chronic myocardial ischemia Phase III trial had treated four patients at two sites, with randomized enrollment planned after completing its roll-in cohort. The company expected to begin enrollment in the allogeneic CardiALLO heart-failure trial in Q4 2023. Its COVID-related ARDS trial was deprioritized. CMS coverage of up to $20,000 per patient for both CardiAMP pivotal trials may offset some trial costs.
- Partnering and regulatory: BioCardia expected to finalize up to two Helix licensing and development relationships in Q4 2023. It had submitted the CardiAMP system to Japan’s PMDA for consultation; further regulatory interactions were expected. These were plans and expectations, not completed outcomes.
- Capital access and listing: The ATM prospectus supplement expired October 20, 2023; future ATM sales depend on a replacement registration statement and applicable requirements. The company disclosed that it was not compliant with Nasdaq minimum market-value and $1.00 bid-price requirements, with stated deadlines of March 4 and March 11, 2024. Failure to regain compliance could lead to delisting and make fundraising more difficult.
- The company reported no material legal proceedings, no off-balance-sheet arrangements, and no material change in market-risk exposure. It noted that COVID-19 and related disruptions could still affect trials, operations, liquidity, and capital access.
Most important facts for investors to verify
- Whether BioCardia raised sufficient capital to address the disclosed cash runway and going-concern uncertainty.
- Subsequent cash balances, operating cash burn, cost-reduction effects, and any financing terms or dilution.
- Final one-year CardiAMP heart-failure outcomes, interpretation of subgroup findings, and FDA feedback or decisions on a follow-on protocol.
- Progress and funding for the chronic ischemia and CardiALLO trials, and whether anticipated Helix partnerships or grants were secured.
- Compliance with Nasdaq listing requirements and the status of any replacement ATM registration statement.