BioCardia(US:BCDA)2024-05-14 20:03Financial Performance - As of March 31, 2024, BioCardia reported total assets of $2,679,000, a decrease from $2,987,000 as of December 31, 2023[11]. - The company experienced a net loss of $2,267,000 for the three months ended March 31, 2024, compared to a net loss of $3,501,000 for the same period in 2023, representing a 35% improvement[14]. - Total costs and expenses decreased to $2,330,000 in Q1 2024 from $3,574,000 in Q1 2023, reflecting a reduction of approximately 35%[14]. - The accumulated deficit increased to approximately $154.4 million as of March 31, 2024, compared to $152.2 million at the end of 2023[11]. - The net loss for Q1 2024 was $2,267,000 compared to a net loss of $3,501,000 in Q1 2023, indicating an improvement of about 35.3%[95]. - Net cash used in operating activities decreased from $2,560,000 in Q1 2023 to $1,530,000 in Q1 2024, a reduction of approximately 40.2%[98]. - Net cash provided by financing activities increased to $1,376,000 in Q1 2024 from $64,000 in Q1 2023, a significant increase of over 2100%[100]. - Cash and cash equivalents at the end of Q1 2024 were $949,000, down from $1,103,000 at the end of 2023[11]. - Cash and cash equivalents as of March 31, 2024, were $949,000, which is insufficient to fund planned expenditures beyond Q2 2024[106]. Revenue and Expenses - Revenue from collaboration agreements was $55,000 for the three months ended March 31, 2024, down from $64,000 in the same period of 2023[14]. - Research and development expenses decreased to $1,241,000 in Q1 2024 from $2,384,000 in Q1 2023, a reduction of about 48% due to clinical staff reductions[96]. - Selling, general and administrative expenses decreased to $1,089,000 in Q1 2024 from $1,190,000 in Q1 2023, a decrease of approximately 8.5%[96]. - Share-based compensation expense for the three months ended March 31, 2024, was $204,000, down from $278,000 in the same period of 2023[54]. Capital and Funding - The company plans to raise additional capital to fund operations beyond June 2024, as current cash levels are insufficient[27]. - Future funding requirements are anticipated to increase due to ongoing development activities and regulatory approvals[105]. - The company plans to raise additional capital to continue development beyond Q2 2024, potentially through various financing methods[106]. Clinical Trials and Development - BioCardia is focused on developing cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, with ongoing clinical trials for its CardiAMP® and MSC therapy platforms[23]. - The CardiAMP Heart Failure Trial has enrolled 125 patients, with interim results showing a 37% relative risk reduction in all-cause heart death equivalents and a 9% reduction in non-fatal heart attack, stroke, and hospitalization due to heart failure (MACCE) over a mean follow-up of 20 months[70]. - In a subgroup analysis of patients with elevated NTproBNP, there was an 86.2% relative risk reduction in heart death equivalents and a 23.9% reduction in MACCE, with rates of heart death equivalents at 2.9% for treated patients compared to 21.1% for controls[73]. - The CardiAMP Cell Therapy Heart Failure II Trial, approved by the FDA, aims to enroll up to 250 patients and has over 90% power to meet its primary endpoint based on previous trial results[74][75]. - The CardiAMP Cell Therapy for Chronic Myocardial Ischemia trial is designed to support safety and efficacy for patients with refractory angina, with an average 107-second increase in exercise tolerance and an 82% reduction in angina episodes reported[78]. - The FDA approved the IND application for a Phase I/II trial of the allogeneic MSC for HFrEF, with the first cohort initiated in December 2023 and no adverse events reported[79]. - The Helix biotherapeutic delivery system is being utilized for targeted delivery of biologic agents to the heart, with partnerships expected to enhance treatment options and revenue sharing opportunities[81]. - The Morph steerable introducer is transitioning to the new FDA cleared Morph DNA platform, with a submission for a product family expected in Q2 2024 and anticipated approval in Q3 2024[83]. - The company generated modest revenue from product sales, including the AVANCE steerable introducer, and from collaboration agreements with corporate and academic institutions[84]. Compliance and Risks - The company is not in compliance with Nasdaq listing requirements, specifically a minimum market value of listed securities of at least $35.0 million and a minimum closing bid price of $1.00 per share[123]. - On March 12, 2024, the company submitted a hearing request to appeal the delisting determinations from Nasdaq, which was granted on May 13, 2024, subject to compliance with certain conditions[123]. - The company expects to maintain compliance with the Minimum Bid Price Requirement for ten consecutive trading days on or before June 24, 2024, following a reverse stock split[123]. - The company has evaluated its disclosure controls and procedures, concluding they are effective at a reasonable assurance level as of March 31, 2024[118]. - There were no changes to the internal control over financial reporting that materially affected the company during the three months ended March 31, 2024[119]. - The company does not believe it is currently party to any pending legal proceedings that could materially affect its business or financial position[120]. - The company continues to monitor and evaluate its internal processes related to foreign currency exchange and potential hedging strategies[117]. - The company does not currently engage in hedging for foreign currency risks and believes it has limited exposure to foreign currency exchange rate fluctuations[117]. - As of March 31, 2024, the company has no material changes in market risks, with cash and cash equivalents having maturities of less than three months[115]. - A hypothetical 100 basis point increase or decrease in interest rates would have an immaterial pre-tax impact on the company's results of operations[116].