BioCardia(BCDA) - 2025 Q2 - Quarterly Report

Part I. FINANCIAL INFORMATION Unaudited Condensed Consolidated Financial Statements The company reported a net loss of $4.8 million for the first half of 2025, with $980,000 in cash and a $164.9 million accumulated deficit, raising substantial doubt about its going concern ability Condensed Consolidated Balance Sheets Total assets decreased to $2.1 million by June 30, 2025, from $3.7 million at year-end 2024, while total liabilities increased to $4.0 million, resulting in a $1.9 million stockholders' deficit Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $980 | $2,371 | | Total current assets | $1,199 | $2,622 | | Total assets | $2,089 | $3,724 | | Liabilities & Equity | | | | Total current liabilities | $3,642 | $2,321 | | Total liabilities | $3,975 | $2,887 | | Total stockholders' equity (deficit) | $(1,886) | $837 | | Total liabilities and stockholders' equity (deficit) | $2,089 | $3,724 | Condensed Consolidated Statements of Operations Net losses increased to $2.0 million for Q2 2025 and $4.8 million for the first half of 2025, primarily due to higher research and development expenses and zero collaboration revenue Statement of Operations Summary (in thousands) | Metric | Q2 2025 | Q2 2024 | Six Months 2025 | Six Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Collaboration agreement revenue | $0 | $3 | $0 | $58 | | Research and development | $1,368 | $800 | $2,898 | $2,041 | | Selling, general and administrative | $683 | $852 | $1,879 | $1,941 | | Operating loss | $(2,051) | $(1,649) | $(4,777) | $(3,924) | | Net loss | $(2,049) | $(1,646) | $(4,761) | $(3,913) | | Net loss per share, basic and diluted | $(0.40) | $(0.88) | $(0.98) | $(2.20) | Condensed Consolidated Statements of Cash Flows Net cash used in operating activities increased to $3.3 million for the first half of 2025, while financing activities provided $1.9 million, resulting in a $1.4 million decrease in cash, ending at $980,000 Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(3,267) | $(2,842) | | Net cash used in investing activities | $(1) | $(3) | | Net cash provided by financing activities | $1,877 | $3,163 | | Net change in cash and cash equivalents | $(1,391) | $318 | | Cash and cash equivalents at end of period | $980 | $1,421 | Notes to Unaudited Condensed Consolidated Financial Statements Notes reveal substantial doubt about the company's going concern ability, with $980,000 cash insufficient beyond October 2025, necessitating ongoing capital raises through private placements and ATM offerings - The company is a clinical-stage entity focused on cellular therapeutics for cardiovascular and pulmonary diseases, with its CardiAMP® and allogeneic MSC platforms in clinical trials[23] - Management states that cash and cash equivalents of $980,000 as of June 30, 2025, are insufficient to fund planned expenditures beyond October 2025, raising substantial doubt about the company's ability to continue as a going concern[29] - In the first half of 2025, the company raised gross proceeds of $775,000 in April and $570,000 in June through private placements of common stock and warrants[51][53] - Subsequent to the quarter end, between July 1 and August 8, 2025, the company sold 296,422 shares of common stock under its ATM offering for gross proceeds of $769,000[65] Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses advancing clinical-stage cell therapy programs, noting increased R&D expenses and a higher net loss for H1 2025, with critically low liquidity and substantial doubt about going concern without further capital - The company is advancing its CardiAMP® autologous cell therapy platform in pivotal trials for ischemic heart failure (HFrEF) and chronic myocardial ischemia (CMI), and its allogeneic MSC therapy for HFrEF[68] - The company submitted two-year data from its CardiAMP HF trial to Japan's PMDA and plans to meet with the FDA to discuss the potential for approval based on existing data[74][75] - The company's cash and cash equivalents of $980,000 as of June 30, 2025, are not sufficient to fund operations beyond October 2025, raising substantial doubt about its ability to continue as a going concern[111][115] Results of Operations Collaboration revenue dropped to zero, while research and development expenses increased by approximately $900,000 to $2.9 million, widening the operating loss to $4.8 million for the first half of 2025 Comparison of Operations for Six Months Ended June 30 (in thousands) | Item | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Collaboration agreement revenue | $0 | $58 | $(58) | | Research and development | $2,898 | $2,041 | $857 | | Selling, general and administrative | $1,879 | $1,941 | $(62) | | Operating loss | $(4,777) | $(3,924) | $(853) | Liquidity and Capital Resources Liquidity is severely constrained with $980,000 cash and a $164.9 million accumulated deficit, as $3.3 million was used in operations while $1.9 million was raised through financing activities - As of June 30, 2025, the company had cash and cash equivalents of $980,000 and an accumulated deficit of approximately $164.9 million[100] - Net cash used in operating activities increased to $3.3 million in the first six months of 2025, up from $2.8 million in the same period of 2024, due to increased trial activities[101] - Net cash from financing activities was $1.9 million in the first six months of 2025, sourced from the sale of common stock and warrants[102] Quantitative and Qualitative Disclosures About Market Risk The company reports no material changes in market risks, with primary exposure limited to short-term cash and cash equivalents, and insignificant foreign currency risk - The company's market risk is limited to its cash and cash equivalents, which have maturities of less than three months[121] - A hypothetical 100 basis point change in interest rates is expected to have an immaterial impact on financial results[122] Controls and Procedures Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting during the quarter - The CEO and CFO concluded that as of June 30, 2025, the company's disclosure controls and procedures were effective at a reasonable assurance level[124] - No changes occurred during the quarter that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[125] Part II. OTHER INFORMATION Legal Proceedings The company is not currently a party to any pending legal proceedings expected to have a material adverse effect on its business or financial position - Management does not believe the Company is party to any current pending legal proceedings[127] Risk Factors A significant risk is non-compliance with Nasdaq's $2.5 million minimum stockholders' equity requirement, with an extension until September 29, 2025, to regain compliance and avoid delisting - The company is not in compliance with the Nasdaq's minimum stockholders' equity requirement of $2.5 million for continued listing[129] - Nasdaq has granted the company an extension until September 29, 2025, to regain compliance[129] - Failure to regain compliance will subject the company's common stock to delisting, which could materially affect operations and financial results[129] Unregistered Sales of Equity Securities and Use of Proceeds No unregistered sales of equity securities occurred during the reporting period - None[130] Exhibits This section lists exhibits filed with the Form 10-Q, including corporate documents, securities agreements, officer certifications, and XBRL data