Financial Performance - Net loss for the three months ended September 30, 2024, was $1,737,000, a decrease from a net loss of $2,574,000 for the same period in 2023, reflecting a 32.6% improvement[12] - Net loss per share improved to $(0.61) for the three months ended September 30, 2024, compared to $(1.79) for the same period in 2023, a 66.1% enhancement[12] - As of September 30, 2024, BioCardia, Inc. reported a net loss of $5.65 million, a decrease from a net loss of $9.5 million for the same period in 2023, representing a 40% improvement[16] - The company has incurred net losses and negative cash flows from operations since inception, with expectations of continued losses as clinical trials advance[24] - As of September 30, 2024, the company had an accumulated deficit of approximately $157.8 million and anticipates continuing to incur net losses for the next several years[89] Assets and Liabilities - Total current assets increased to $5,056,000 as of September 30, 2024, compared to $1,461,000 as of December 31, 2023, representing a growth of 246%[10] - Cash and cash equivalents increased significantly to $4,930,000 as of September 30, 2024, compared to $1,103,000 as of December 31, 2023, marking a rise of 346%[10] - Total liabilities decreased to $3,514,000 as of September 30, 2024, from $4,590,000 as of December 31, 2023, showing a reduction of 23.4%[10] - Total stockholders' equity improved to $2,753,000 as of September 30, 2024, from a deficit of $(1,603,000) as of December 31, 2023, indicating a positive shift in equity[10] - Cash and cash equivalents as of September 30, 2024 were approximately $4.9 million[89] Research and Development - Research and development expenses for the nine months ended September 30, 2024, totaled $2,972,000, down from $6,570,000 for the same period in 2023, indicating a reduction of 54.7%[12] - BioCardia's CardiAMP® therapy platform is in pivotal trials for ischemic heart failure with reduced ejection fraction (HFrEF) and refractory angina, targeting significant unmet medical needs[18] - The company has been focusing on research and development of cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases[18] - The company plans to increase research and development expenses to continue pivotal trials for CardiAMP and CardiALLO cell therapies[80] Financing Activities - BioCardia's financing activities generated $9.29 million in net cash for the nine months ended September 30, 2024, compared to $2.61 million in the prior year[16] - The company raised gross proceeds of $7.2 million from a public offering on September 3, 2024, with associated issuance costs of $926,000[42] - The company sold 412,239 shares under ATM offerings during the nine months ended September 30, 2024, generating approximately $2.4 million in gross proceeds[46] - Net cash provided by financing activities was approximately $9.3 million for the nine months ended September 30, 2024, compared to approximately $2.6 million for the same period in 2023[91] Operational Challenges - BioCardia, Inc. plans to raise additional capital to fund operations beyond the second quarter of 2025, as current cash reserves are insufficient[25] - The company anticipates needing additional funding to continue the development of its therapeutic candidates, potentially through non-dilutive collaboration, licensing arrangements, or debt/equity financing[98] - There is substantial doubt about the company's ability to continue as a going concern within one year, heavily reliant on its ability to raise additional capital[102] - If the company cannot secure adequate funds, it may need to reduce operating expenses or cease operations[102] Share-Based Compensation - The company reported share-based compensation expenses of $565,000 for the nine months ended September 30, 2024, down from $846,000 in the same period of 2023[16] - Share-based compensation expense for Q3 2024 was $177,000, a decrease of 29.4% from $251,000 in Q3 2023[8] - Total share-based compensation for the nine months ended September 30, 2024, was $565,000, down 33.2% from $846,000 in the same period of 2023[8] - Unrecognized share-based compensation for options granted through September 30, 2024, is $837,000, to be recognized over 1.8 years[49] Clinical Trials and Product Development - The CardiAMP Heart Failure Trial enrolled 115 patients, with final data transfer expected in Q1 2025[61] - Interim results of the CardiAMP Heart Failure II Trial showed an 86% relative risk reduction in mortality[63] - The CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial is designed to enroll up to 343 patients, focusing on refractory angina[68] - The open-label roll-in cohort for chronic myocardial ischemia showed an average 107-second increase in exercise tolerance and an 82% reduction in angina episodes[69] - The FDA approved a protocol amendment for the CardiAMP Heart Failure II Trial, allowing more patients to receive treatment[65] - The FDA approved the Morph-DNA product family for market release in August 2024, with first commercial devices expected in November 2024[75] - The company has entered into biotherapeutic delivery partnerships, including a Phase I/II Clinical Study with StemCardia, expected to enhance future treatment options for heart disease[73] Lease and Operating Expenses - The operating lease expense was $121,000 for both the three months ended September 30, 2024, and 2023, and $362,000 for both the nine months ended September 30, 2024, and 2023[37] - Future minimum lease payments under the operating lease total $1.18 million as of September 30, 2024, with total operating lease liabilities at $1.05 million[38] - The company’s weighted average remaining lease term was 2.34 years, with a weighted average discount rate of 10.74% as of September 30, 2024[37] Revenue - Revenue for the three months ended September 30, 2024 was $0, compared to $357,000 for the same period in 2023, and for the nine months ended September 30, 2024, revenue decreased to $58,000 from $464,000 in 2023[86]
BioCardia(BCDA) - 2024 Q3 - Quarterly Report