BioCardia, Inc. — Q3 2021 Form 10-Q
Reporting period: Quarter and nine months ended September 30, 2021. Unaudited results; amounts below are in millions unless stated otherwise. BioCardia is a clinical-stage cardiovascular and pulmonary therapeutics company, with its lead CardiAMP cell therapy in pivotal trials.
Financial performance and position
- Q3 revenue: $0.821 million, versus $0.034 million in Q3 2020. Collaboration revenue was $0.820 million; product revenue was $0.001 million.
- Nine-month revenue: $0.936 million, versus $0.099 million in 2020. Management attributed the increase primarily to greater collaboration activity, which can vary substantially between quarters.
- Q3 net loss: $2.706 million, compared with $3.848 million a year earlier. Nine-month net loss was $9.162 million, versus $12.015 million.
- Expenses: Q3 R&D was $2.240 million and SG&A was $1.289 million. For nine months, R&D was $6.443 million and SG&A was $3.662 million. The company cited lower external clinical-service costs, stock compensation, compensation, and professional fees.
- Margins: Gross margin is not informative given minimal product revenue and no reported cost of goods sold in 2021. The filing does not present a meaningful operating margin.
- Cash flow: Nine-month operating cash use was $7.391 million, compared with $8.940 million in 2020; investing cash use was $0.075 million. Financing provided $1.947 million, primarily from common-stock sales. Cash declined $5.519 million during the period.
- Liquidity and debt: Cash and cash equivalents were $15.888 million at September 30, down from $21.407 million at year-end 2020. Current liabilities were $3.918 million; total liabilities were also $3.918 million. No debt balance is presented on the balance sheet. Management said cash was expected to fund planned operations for at least 12 months from the filing date.
- Equity: Stockholders’ equity was $13.412 million, down from $19.176 million at year-end 2020. Shares outstanding were 16.871 million at quarter-end. The company reported 1.684 million options and 2.425 million warrants outstanding.
Material changes and developments
- Revenue rose sharply year over year, but remained modest and was largely collaboration-based. Management cautioned that partner activity drives timing and quarter-to-quarter variability.
- Operating expenses and net losses decreased year over year for both the quarter and nine-month period.
- Under its 36-month Lincoln Park agreement, BioCardia may sell up to $20 million of stock subject to contractual limits. It had received $2 million in gross proceeds from the initial purchase and made no further sales under the agreement as of September 30, 2021.
- The company settled related litigation in March 2021; claims were dismissed and the settlement had no material benefit or liability. A $0.562 million receivable related to the litigation funding arrangement remained outstanding at quarter-end.
Outlook, risks, and contingencies
- Management expects continued operating losses and negative operating cash flows for at least several years, with increased costs as clinical development advances. It anticipates needing additional funding; equity financing could dilute shareholders, while debt or partnering may impose restrictions or require relinquishing rights.
- The CardiAMP heart-failure Phase III trial was active at 24 sites, with 106 patients enrolled and three control patients crossing over to treatment. A June 2021 DSMB review found no safety concerns and recommended continuation; another review was anticipated in early February 2022.
- The chronic myocardial ischemia Phase III trial had been activated and one patient treated. FDA approved a protocol supplement in Q3 2021. The company intended to use an adaptive efficacy assessment, with aspects still subject to FDA study considerations.
- For allogeneic programs, manufacturing validation and stability work was complete, while preclinical animal testing remained underway for planned IND submissions for heart failure and COVID-19-related ARDS.
- COVID-19 had disrupted development programs and delayed clinical, regulatory, and commercialization timelines. Further effects could include slower enrollment, site delays, supply disruption, workforce shortages, and reduced access to capital.
- The filing provides no revenue or earnings guidance. The company expected 2021 operating cash use to decrease year over year, but emphasized that estimates depend on assumptions and funding needs remain uncertain.
Key facts for investors to verify
- Whether cash burn and the stated 12-month runway remain consistent with current trial spending and financing needs.
- Subsequent enrollment, DSMB review, and FDA-related milestones for both CardiAMP pivotal trials.
- Whether collaboration revenue is recurring or reflects variable partner activity, and how it affects reported results.
- Progress and timing of the planned allogeneic IND submissions and preclinical results.
- Potential dilution from future Lincoln Park sales, options, warrants, or other financing, and the status of the $0.562 million related-party receivable.