BioCardia, Inc. — Q1 2024 Form 10-Q
Reporting period: Three months ended March 31, 2024. Financial statements are unaudited and amounts below are in U.S. dollars unless noted. BioCardia is a clinical-stage company developing cell therapies for cardiovascular and pulmonary diseases and a minimally invasive cardiac delivery platform.
Financial results and liquidity
| Metric | Q1 2024 | Q1 2023 |
|---|---|---|
| Revenue | $55,000 | $64,000 |
| Research and development | $1.241 million | $2.384 million |
| Selling, general and administrative | $1.089 million | $1.190 million |
| Operating loss | $2.275 million | $3.510 million |
| Net loss | $2.267 million | $3.501 million |
| Net loss per share, basic and diluted | $0.09 | $0.17 |
| Cash used in operating activities | $1.530 million | $2.560 million |
- Revenue was collaboration-agreement revenue; the filing does not report a separate product-revenue amount for the quarter. No gross margin is presented.
- Cash and cash equivalents were $949,000 at March 31, down from $1.103 million at year-end. Total assets were $2.679 million; total liabilities were $4.954 million; stockholders’ deficit was $2.275 million.
- Current assets of $1.259 million were below current liabilities of $4.071 million. Liabilities included $1.228 million of operating lease obligations in total. The balance sheet reports no debt balance.
- Financing provided $1.376 million net in Q1, including a February private placement with $875,000 gross proceeds and ATM sales with $591,000 gross proceeds. The company issued 2,012,978 shares and warrants for 1,006,488 shares in the private placement. Q1 ATM sales included 1,156,877 shares.
Changes versus the prior-year quarter
- Net loss narrowed by $1.234 million, mainly as R&D costs fell by $1.143 million. Management attributed the decrease primarily to clinical staff reductions and lower personnel costs after CardiAMP heart-failure trial enrollment was completed in 2023.
- SG&A decreased by $101,000, primarily following personnel role realignment after 2023 staff reductions.
- Operating cash use declined by $1.030 million, primarily reflecting lower R&D spending. Revenue decreased by $9,000; management cautioned that collaboration revenue timing depends on partner activity and may vary.
Outlook, programs and principal risks
- Going concern and funding: Management states that $949,000 of cash is insufficient to fund planned expenditures and obligations beyond Q2 2024. It expects continuing losses and negative operating cash flows and identifies substantial doubt about the company’s ability to continue as a going concern within one year after issuance of the statements. Additional capital is required; planned sources include equity, debt, collaborations, licensing and other funding, none assured. Financing may be highly dilutive or require surrendering valuable rights. Without funding, the company may reduce or delay programs or cease operations.
- CardiAMP heart failure: The ongoing trial enrolled 125 patients. Randomization ended in October 2023 after the study was determined unlikely to meet its primary efficacy endpoint as designed, primarily because both treatment and control groups improved on six-minute walk distance. Interim results presented in March 2024 described favorable trends in some outcomes and a stronger subgroup result among patients with elevated NTproBNP; these are not a substitute for the final trial outcome. Results for all enrolled patients with at least one year of follow-up were expected in October 2024, with final data lock targeted for Q4 2024.
- Confirmatory heart-failure trial: The FDA-approved Phase III CardiAMP HF II trial was activated in Q1 2024. It plans to enroll up to 250 patients, with enrollment targeted for completion two years after the first patient is enrolled.
- Chronic myocardial ischemia: The Phase III CardiAMP trial plans to enroll up to 343 patients. The company intends an adaptive efficacy assessment after 100 patients reach the primary endpoint, but aspects of the plan remained under discussion with the FDA.
- CardiALLO: The allogeneic MSC heart-failure trial began its lowest-dose cohort in December 2023. The company reported no treatment-emergent adverse events, arrhythmias, rejection or allergic response to date. Further development depends in part on grant funding and partnering.
- Devices and partnerships: BioCardia reported a StemCardia delivery partnership in March 2024. A Morph-DNA product-family FDA submission was planned for Q2 2024, with approval anticipated in Q3; these are management targets, not assured outcomes.
- Nasdaq listing: The company was out of compliance with minimum market-value and bid-price requirements. On May 13, 2024, the Nasdaq Hearings Panel granted continued listing subject to conditions, including regaining the minimum bid price for ten consecutive trading days by June 24, 2024 (which the company expected to pursue following a reverse split subject to stockholder approval) and meeting minimum stockholders’ equity requirements by September 2, 2024. Failure could result in delisting and impair access to capital.
- The company reported no material market-risk changes, no current legal proceedings management believes are pending, and no material changes in internal control over financial reporting. Disclosure controls were assessed as effective at a reasonable assurance level.
Important facts for investors to verify
- Whether the company raised sufficient capital after March 31 to fund operations, and the actual cash runway and financing terms. The filing reports an additional 467,727 ATM shares sold from April 1 through May 13 for $184,000 gross.
- Final CardiAMP heart-failure results, especially the primary endpoint and whether interim subgroup findings are confirmed.
- Enrollment, safety and progress in the CardiAMP HF II, CardiAMP CMI and CardiALLO trials, including any FDA feedback on the proposed adaptive analysis.
- Whether BioCardia met the Nasdaq Panel’s bid-price and stockholders’ equity conditions, and whether any reverse split was approved and implemented.
- Potential dilution from outstanding options and warrants: 5,574,027 common-stock equivalents were excluded from diluted loss per share at March 31, 2024 because they were antidilutive.