BioCardia, Inc. (NASDAQ:BCDA) Q2 2023 Earnings Conference Call August 9, 2023 4:30 PM ET Company Participants Miranda Peto - Investor Relations Peter Altman - President & Chief Executive Officer David McClung - Chief Financial Officer Conference Call Participants Joe Pantginis - H.C. Wainwright Operator Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to the BioCardia 2023 Second Quarter Conference Call. At this time, all participants are in a listen-only mode. [Operator Instruct ...

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 June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 0-21419 BioCardia, Inc. (Exact name of registrant as specified in its charter) Delaware 23-2753988 (State or another jurisdiction of incorporation or organization) (I ...

BioCardia, Inc. (NASDAQ:BCDA) Q1 2023 Earnings Conference Call May 10, 2023 4:30 PM ET Company Participants Miranda Peto – Investor Relations Peter Altman – President and Chief Executive Officer Dave McClung – Chief Financial Officer Conference Call Participants Joe Pantginis – H.C. Wainwright Kumar Raja – Roth Capital Laura Suriel – Alliance Global Partners Operator Good day ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to the BioCardia 2023 First Quarter Conference Call. At ...

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 March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 0-21419 BioCardia, Inc. (Exact name of registrant as specified in its charter) Delaware 23-2753988 (State or another jurisdiction of incorporation or organization) ( ...

Financial Data and Key Metrics Changes - Revenues for fiscal year 2022 increased to $1.4 million from $1.0 million in fiscal year 2021, primarily due to increased revenue from collaborative partners [23] - Total operating expenses decreased by approximately $300,000 year over year, totaling $13.3 million in 2022 compared to $13.6 million in 2021 [24] - Net loss in 2022 was $11.9 million compared to a net loss of $12.6 million in 2021, with cash used in operations totaling $10.6 million in both years [25] Business Line Data and Key Metrics Changes - The CardiAMP cell therapy platform is being advanced in two cardiac clinical indications, with significant patient enrollment and positive clinical data reported [9][10] - The allogeneic mesenchymal stem cell program for ischemic heart failure (BCDA-03) is designed for patients ineligible for the autologous therapy, with clinical grade cells ready for use [17][18] - The allogeneic mesenchymal stem cell program for acute respiratory distress syndrome (BCDA-04) is expected to commence following the initiation of BCDA-03 [19] Market Data and Key Metrics Changes - The reachable US market for the CardiAMP cell therapy programs is estimated at 1.6 million patients [9] - The company anticipates significant licensing and royalty revenues from its therapies if proven effective and commercialized [23] Company Strategy and Development Direction - The company is focused on advancing two cell therapy platforms targeting unmet cardiovascular and pulmonary diseases [6] - BioCardia aims to partner its CardiAMP cell therapy platform internationally and license its Neurokinin-1 Receptor Positive mesenchymal stem cells for other clinical indications [20] - The company is also looking to monetize its Avance transseptal introducer sheath product, which has seen significant acquisition interest in the market [21] Management's Comments on Operating Environment and Future Outlook - Management highlighted the ongoing need for new therapeutic solutions in heart failure, with current treatments showing limited impact on mortality [7] - The company is optimistic about the upcoming discussions with the FDA regarding the adaptive statistical analysis plan, which could enhance the trial's design and outcomes [35][52] - Management emphasized the importance of maximizing the probability of technical success while ensuring near-term commercial viability [36] Other Important Information - The company has received breakthrough device designation from the FDA for its CardiAMP cell therapy in ischemic heart failure [36] - The next pre-specified formal data safety monitoring board review is anticipated in the second quarter of 2023 [12] Q&A Session Summary Question: Can you provide perspective on the blinded echo data for the rolling cohort? - Management explained that the patient population included those with a left ventricular ejection fraction of 20% to 40%, and the results showed a 35% improvement in ejection fraction with 100% survival at two-year follow-up [28][29] Question: What are the immediate needs regarding manufacturing capacity? - Management stated that current manufacturing capabilities are sufficient for all ongoing clinical trials, with room for expansion if needed [30][32] Question: What are the expectations for the upcoming FDA call? - Management indicated that they expect clarity on the adaptive statistical analysis plan and emphasized the importance of patient safety data in trial design [51][52] Question: What is the status of the BCDA-02 trial? - Management confirmed that the rolling cohort is up to 10 patients, and they are working to streamline the trial design for faster enrollment [53][54] Question: How does the company plan to enhance enrollment across its trials? - Management noted that patients excluded from the CardiAMP trial could qualify for the chronic myocardial ischemia trial, providing multiple opportunities for patient inclusion [55]

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, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 0-21419 BIOCARDIA, Inc. (Exact name of registrant as specified in its charter) Delaware 23-2753988 (State or other jurisdiction of incorporation or organization) (I.R.S. ...

BioCardia, Inc. (NASDAQ:BCDA) Q3 2022 Earnings Conference Call November 9, 2022 4:30 PM ET Company Participants Jules Abraham - CORE IR Peter Altman - President & CEO David McClung - CFO Conference Call Participants Joe Pantginis - H.C. Wainwright Michael Okunewitch - Maxim James Molloy - Alliance Global Partners Operator Good day, and welcome to the BioCardia 2022 Third Quarter Conference Call. [Operator Instructions]. I would now like to turn the conference over to Jules Abraham of CORE IR, the Company's ...

Financial Data and Key Metrics Changes - In Q2 2022, the company reported revenues of approximately $1 million with a net loss of $2.5 million, an improvement from a net loss of $3.5 million in Q2 2021, primarily due to increased collaboration revenues [17][18] - Research and development expenses remained flat at $2.3 million in Q2 2022 compared to $2.4 million in Q2 2021, while SG&A expenses were unchanged at $1.2 million [19] - The company ended Q2 2022 with cash totaling $8.6 million, providing a runway to the first quarter of 2023 [19] Business Line Data and Key Metrics Changes - The company is focused on advancing two cell therapy platforms targeting ischemic heart failure and chronic myocardial ischemia, with the lead heart failure program having 114 patients enrolled [8][12] - The company has also initiated an allogeneic MSC program for heart failure (BCDA-03) and a program for acute respiratory distress syndrome (BCDA-04), with the latter approved by the FDA in April [15][16] Market Data and Key Metrics Changes - The Center for Medicare and Medicaid Services (CMS) increased reimbursement for clinical sites to $20,000 per patient procedure, retroactive to April 1, 2022, enhancing confidence among clinical partners [8] - The company is expanding its clinical trial sites, including the activation of a site in Canada, which is critical for enrollment [9][21] Company Strategy and Development Direction - The company aims to complete enrollment in the CardiAMP Heart Failure Trial by 2023 and the CardiAMP Chronic Myocardial Ischemia Trial with an interim readout [12] - The company is pursuing international partnerships for its CardiAMP Cell Therapy platform and licensing its catheter-based biotherapeutic delivery system [17] Management's Comments on Operating Environment and Future Outlook - Management highlighted the significant unmet need in heart failure, affecting over 26 million people worldwide, and emphasized the importance of their breakthrough designation from the FDA [6][7] - The company is optimistic about its allogeneic MSC program and its potential to address local and systemic inflammation in patients recovering from acute respiratory distress [16][40] Other Important Information - The company is working on business development activities to secure non-dilutive financing and has raised $1.5 million by selling shares under its ATM facility [19][20] - The company is actively engaging with Japan's PMDA for the approval of its CardiAMP Cell Therapy, with a focus on enhancing comfort with their clinical data [13][28] Q&A Session Summary Question: When do you expect the first patient to be treated in Canada and when do you expect the other three sites to come onboard? - The first site in Canada is currently screening patients, and the other three sites are expected to come onboard soon [21] Question: What kind of results are you seeing in the U.S. regarding patient enrollment? - The company is working to enhance the ease of enrolling patients and has seen sites actively enrolling as staffing improves [23][24] Question: Can you discuss the next steps with PMDA in Japan? - The next steps involve resubmitting information in a new format and addressing feedback from the last consultation [48] Question: What is the strategy for commercialization in Japan if approved? - The company is exploring distribution deals and has engaged with potential partners in Japan [31] Question: How does the allogeneic program differentiate from other mesenchymal stem cell approaches? - The allogeneic program utilizes Neurokinin 1 receptor positive cells, which are believed to enhance therapeutic efficacy [35][36] Question: How easy or difficult will it be to enroll patients given the unpredictable trajectory of COVID-19? - The trial design allows for a smaller number of patients, and logistical challenges are manageable based on prior experience [44]