BioCardia, Inc. — Q3 2022 Form 10-Q
Reporting period: Quarter and nine months ended September 30, 2022. Financial statements are unaudited; amounts below are in millions unless otherwise noted.
Business context
BioCardia is a clinical-stage company developing cell therapies for cardiovascular and pulmonary diseases. Its lead CardiAMP autologous programs target ischemic heart failure and chronic myocardial ischemia; its investigational allogeneic cell platform targets heart failure and COVID-19-related acute respiratory distress syndrome. The company also earns modest product and collaboration revenue from enabling devices and delivery systems.
Financial results and liquidity
| Metric | Q3 2022 | Q3 2021 | 9M 2022 | 9M 2021 |
|---|---|---|---|---|
| Revenue | $0.212 | $0.821 | $1.246 | $0.936 |
| Operating loss | $(3.060) | $(2.708) | $(8.883) | $(9.169) |
| Net loss | $(3.057) | $(2.706) | $(8.879) | $(9.162) |
| R&D expense | $2.144 | $2.240 | $6.634 | $6.443 |
| SG&A expense | $1.128 | $1.289 | $3.495 | $3.662 |
- Q3 revenue fell 74% year over year, primarily from the timing of collaboration deliverables; nine-month revenue rose 33%. Collaboration revenue is variable between quarters. Product revenue remained minimal.
- Q3 net loss increased 13% year over year; nine-month net loss narrowed 3%. The company reported no meaningful positive operating margin; revenue was substantially below operating expenses.
- Cash and cash equivalents were $6.667 at September 30, 2022, down from $12.872 at December 31, 2021. Nine-month operating cash use was $7.564, investing cash use $0.068, and financing cash inflow $1.427. Net cash declined $6.205.
- Total assets were $9.179 and total liabilities $5.082. Current assets were $7.154 versus current liabilities of $3.684. No borrowings are reported; liabilities include operating lease obligations of $1.702, of which $0.304 is current.
- Equity financing included approximately $1.7 million of gross proceeds from the Cantor ATM during the first nine months, with $0.231 million of issuance costs. Shares outstanding were 17,841,927 at September 30, versus 16,871,265 at year-end 2021.
Development, outlook and risks
- The Phase III CardiAMP Heart Failure trial was active at 20 sites with 115 patients enrolled. In August, the independent safety board reported no significant safety concerns and recommended continuing the trial as designed. It suggested considering adaptive statistical analysis; the next formal review was anticipated in March 2023. Trial continuation, efficacy and enrollment outcomes remain uncertain.
- The Phase III CardiAMP Chronic Myocardial Ischemia trial was activated at two centers. CMS reimbursement of up to $20,000 for qualifying procedures in approved IDE studies applies to both CardiAMP programs.
- After quarter-end, the company reported filing the BCDA-03 IND with FDA in early November and anticipated a decision in early December. FDA had approved the BCDA-04 IND in April; trial initiation was expected in 2022, subject to manufacturing lot release and site arrangements.
- Management expects operating losses and negative operating cash flows for at least several years and plans to increase R&D spending as trials advance. There is no specific revenue or earnings guidance in the filing.
- Management stated that September 30 cash was not sufficient to fund planned expenditures and obligations beyond April 2023. The filing identifies substantial doubt about the company’s ability to continue as a going concern within one year after issuance of the statements. Additional financing is required, but is not assured; absent funding, the company may need to cut or delay programs, relinquish rights, or cease operations.
- Additional risks include clinical and regulatory uncertainty, trial enrollment and execution, financing availability and dilution, and potential COVID-19-related disruption to trials, supply chains, operations and capital access. Management reported no material COVID-19 effect on the periods presented and no pending legal proceedings it believed were material.
Important facts for investors to verify
- Cash runway and the timing, amount, terms and availability of new financing; monitor subsequent ATM or other capital raises and resulting dilution.
- Progress and decisions from the CardiAMP Heart Failure DSMB review, including whether an adaptive analysis plan is adopted and what it implies for enrollment and trial endpoints.
- Enrollment, site activation and safety progress in both CardiAMP trials, plus BCDA-03 IND status and BCDA-04 trial launch and manufacturing readiness.
- Quarterly collaboration revenue timing and whether recurring product or partnership revenue grows enough to offset development costs.