BioCardia, Inc. — Q1 2023 Form 10-Q
Reporting period: Three months ended March 31, 2023. The unaudited filing describes BioCardia as a clinical-stage developer of cell therapies for cardiovascular and pulmonary diseases and of a cardiac therapeutic-delivery system.
Financial performance and position
| Metric | Q1 2023 | Q1 2022 / comparison |
|---|---|---|
| Revenue | $64,000 | $60,000 |
| Research and development | $2.384 million | $2.186 million |
| Selling, general and administrative | $1.190 million | $1.201 million |
| Operating loss | $3.510 million | $3.327 million |
| Net loss | $3.501 million | $3.325 million |
| Basic and diluted loss per share | $0.17 | $0.19 |
| Cash used in operating activities | $2.560 million | $2.913 million |
| Cash and cash equivalents, March 31 | $4.857 million | $7.363 million at December 31, 2022 |
| Current assets / current liabilities | $5.289 million / $4.000 million | At March 31, 2023 |
| Total liabilities / stockholders’ equity | $5.228 million / $1.900 million | At March 31, 2023 |
Revenue was primarily collaboration revenue ($64,000); net product revenue was zero, versus $1,000 in Q1 2022. The company reported no income-tax expense or benefit. Its liabilities include operating lease obligations totaling $1.555 million; the balance sheet does not show conventional borrowings.
Material changes and operating developments
- Revenue increased by $4,000, with management attributing variation mainly to the timing of partner activities and deliverables.
- R&D expense increased $198,000, primarily to support the CardiAMP heart-failure trial; SG&A decreased $11,000. Net loss increased $176,000.
- Operating cash use fell $353,000 year over year, which management attributed primarily to working-capital management. Cash declined $2.506 million during the quarter.
- The company sold 106,241 shares through its Cantor Fitzgerald at-the-market (ATM) program for reported gross proceeds of $244,000. Approximately $8.5 million remained available under the program at quarter-end.
- BioCardia transferred substantially all its cash from Silicon Valley Bank after the bank’s March 2023 closure and said it did not expect an impact. At quarter-end, substantially all cash was held at one financial institution, with approximately $4.5 million above FDIC insurance limits.
Outlook, risks and contingencies
- Going concern and funding: Management said the $4.9 million of quarter-end cash was insufficient to fund planned spending and obligations beyond Q3 2023. The filing states there is substantial doubt about the company’s ability to continue as a going concern within one year after issuance of the financial statements. Additional capital is required; planned sources may include collaboration or licensing arrangements, debt or equity. These plans are not assured. Failure to obtain funding could lead to expense reductions, program delays or cuts, relinquishment of rights, or cessation of operations.
- Clinical programs: The CardiAMP Phase III heart-failure trial was active at 20 sites, with 120 patients enrolled. Following FDA discussions, the company submitted an additional supplement on April 26, 2023 proposing an adaptive statistical analysis plan and anticipated a DSMB meeting in June. The filing describes these as expectations, not outcomes. The CardiAMP chronic-myocardial-ischemia trial had treated three patients at two sites; the company planned to complete its roll-in cohort and work with FDA before broader expansion.
- Other development plans: BioCardia expected to begin enrolling patients in its allogeneic NK1R+ MSC heart-failure trial in Q2 2023. It planned to discuss modifying the ARDS trial’s eligibility criteria with FDA; initiation was expected after the heart-failure trial begins.
- Management expects losses and negative operating cash flows to continue for several years, with R&D costs expected to rise as clinical development advances. Collaboration revenue may fluctuate by quarter. Clinical, regulatory, financing, commercialization, supply-chain and pandemic-related uncertainties could affect timing and costs.
- The company reported no legal proceedings it believed were pending, no material change in market risks, and no off-balance-sheet arrangements. Disclosure controls were assessed as effective at a reasonable assurance level.
Important facts for investors to verify
- Whether and when BioCardia obtains sufficient additional financing to address the stated cash runway and going-concern uncertainty, and the dilution or other terms of any financing.
- Progress and enrollment in the CardiAMP and NK1R+ trials, the status of FDA review of the adaptive analysis-plan supplement, and the outcomes of future DSMB and regulatory discussions.
- The ATM offering amounts: the filing reports $244,000 gross proceeds and $13,000 issuance costs in its equity discussion, while the cash-flow statement reports $244,000 of proceeds and $180,000 of issuance costs. The filing text does not clearly reconcile these figures.
- Whether trial, regulatory and commercialization timelines remain achievable given the company’s funding needs and the risks described in the filing.