Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-38999 BIOCARDIA, Inc. (Exact name of registrant as specified in its charter) Delaware 23-2753988 (State or other jurisdiction of incorporation or or ...

SUNNYVALE, Calif., March 20, 2024 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [NASDAQ:BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced it will report its financial results for the year ended December 31, 2023 and provide a corporate update by conference call on Wednesday, March 27, 2024 at 4:30 PM ET. Following management’s formal remarks, there will be a question-and-answer session. Participants can register for the conference ...

SUNNYVALE, Calif., March 20, 2024 (GLOBE NEWSWIRE) -- BioCardia®, Inc. (NASDAQ:BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced it will report its financial results for the year ended December 31, 2023 and provide a corporate update by conference call on Wednesday, March 27, 2024 at 4:30 PM ET. Following management's formal remarks, there will be a question-and-answer session. Participants can register for the conference ...

Partnership targets heart failure, the leading cause of death and a condition with limited treatment optionsBioCardia's biotherapeutic delivery system with established safety profile enables minimally invasive transplantation of StemCardia's off-the-shelf cardiac muscle cells SUNNYVALE, Calif., March 13, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. (NASDAQ:BCDA), a biotechnology company focused on advancing late-stage cell therapy interventions for cardiovascular disorders, and StemCardia, Inc., a biotechnology ...

SUNNYVALE, Calif., March 12, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. (NASDAQ:BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced Centers for Medicare & Medicaid Services (CMS) approval for reimbursement coverage of the confirmatory Phase III clinical trial of CardiAMP autologous cell therapy for the treatment of patients with ischemic heart failure. CMS has reviewed the CardiAMP Heart Failure II Trial and approved the inve ...

CardiAMP cell therapy-treated patients had 37% relative risk reduction in heart death equivalent (death, heart transplant, left ventricular assist device implantation) and 9% relative risk reduction in non-fatal major adverse cardiac and cerebrovascular events (MACCE) at mean 20-month follow-up compared to control patients on guideline-directed heart medications aloneLarge sub-set of treated patients with elevated NTproBNP – a marker of heart distress – showed greater reductions, with 86% relative risk redu ...

SUNNYVALE, Calif., Feb. 08, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. ("BioCardia" or the "Company") (NASDAQ:BCDA), a biotechnology company focused on advancing late-stage cell therapy interventions for cardiovascular disorders, is targeting heart failure and chronic myocardial ischemia as potential indications for its biotherapeutic candidates: autologous CardiAMP® cell therapy and allogeneic CardiALLO™ cell therapy. The Company announces activation of CardiAMP HF II, a randomized controlled pivotal trial o ...

BioCardia, Inc. (NASDAQ:BCDA) Q3 2023 Earnings Conference Call November 8, 2023 4:30 PM ET Company Participants Miranda Peto - Investor Relations Peter Altman - President and Chief Executive Officer David McClung - Chief Financial Officer Operator Ladies and gentlemen, thank you for standing by and welcome to the BioCardia 2023 Third Quarter Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask quest ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-38999 BioCardia, Inc. (Exact name of registrant as specified in its charter) Delaware 23-2753988 (State or another jurisdiction of incorporation or organizat ...

Financial Data and Key Metrics Changes - Revenues for Q2 2023 were approximately $43,000, a significant decrease compared to approximately $975 million for Q1 2022, primarily due to the timing of collaboration agreement revenues [21] - Net loss for Q2 2023 was approximately $3.4 million, compared to $2.5 million in Q2 2022, mainly due to fluctuations in collaboration revenues [21] - Cash and cash equivalents at the end of the quarter were approximately $4.3 million, providing a runway into November without additional capital [22] Business Line Data and Key Metrics Changes - The CardiAMP Autologous Cell Therapy for heart failure (BCDA-01) is currently paused for new patient enrollment following a recommendation from the Data Safety Monitoring Board (DSMB) [7][8] - Enrollment for the Cardiac autologous cell therapy for chronic myocardial ischemia (BCDA-02) is progressing, with expectations to complete enrollment in the rolling cohort by Q4 2023 [15] - The CardiALLO allogeneic cell therapy for ischemic heart failure (BCD03) is in Phase I/II trials, with patient enrollment expected to begin in Q3 2023 [16] Market Data and Key Metrics Changes - The company is seeing significant enrollment increases in its clinical trials, including patients from Canada [6] - The CardiAMP Cell Therapy system submission to Japan's PMDA for ischemic heart failure is progressing, with the consultation expected to take up to four months [12] Company Strategy and Development Direction - The company is focused on advancing its cell therapy platforms to address unmet needs in cardiovascular and pulmonary diseases [5] - BioCardia aims to gather more information to decide next steps for the BCDA-01 program, including the possibility of restarting the trial with a new protocol [9][10] - Business development activities are ongoing, with the goal of closing meaningful deals by the end of the year to avoid financing [18] Management's Comments on Operating Environment and Future Outlook - Management expressed confusion regarding the DSMB's recommendation to pause enrollment, noting that there were no reported safety issues and that patients appeared to show clinical improvement [8][9] - The company remains optimistic about the safety and efficacy of its therapies, with expectations for significant near-term catalysts from its clinical programs [20] Other Important Information - The company has received patents in Japan and Europe for its delivery systems, enhancing its intellectual property portfolio [18][19] - The allogeneic cell therapy trial for acute respiratory distress syndrome (BCDA04) has been deprioritized due to reduced patient populations [17] Q&A Session Summary Question: Focus on DSMB review and trial status - The DSMB's recommendation to pause enrollment is unique, and management is analyzing the data to understand the implications while continuing to randomize patients [24][26] Question: Benchmarks for patient follow-up - Management indicated that key metrics to monitor include mortality rates, major adverse cardiac events, and functional endpoints like the six-minute walk test [30][31]