BioCardia, Inc. (NASDAQ:BCDA) Q4 2023 Results Conference Call March 27, 2024 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. Good afternoon, and welcome to the BioCardia 2023 Year-End Financial Results and Business Update Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions]. Participants on this ...

Exhibit 99.1 BioCardia Reports Fourth Quarter and Full Year 2023 Business Highlights and Financial Results SUNNYVALE, Calif. – March 27, 2024 - BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the year ended December 31, 2023 and filed its annual report on Form 10-K with the Securities and Exchange Commission. The Company will also hold a conference call at 4:30 PM ET today ...

Cell Therapy Development - The company is developing two cell therapy platforms for treating ischemic heart failure with reduced ejection fraction (HFrEF) and chronic myocardial ischemia (CMI) with a focus on significant unmet medical needs [19]. - The CardiAMP Cell Therapy System has been evaluated in three clinical trials, with a Phase III study (CardiAMP HF) completing enrollment in Q4 2023 and final data expected in Q4 2024 [29]. - The FDA granted Breakthrough Device Designation for the CardiAMP Cell Therapy System in January 2022, aimed at expediting approval for novel treatments [30]. - The CardiAMP Phase I trial showed improvement in cardiac function and exercise tolerance, with superior survival compared to historical controls [31]. - The company’s allogeneic CardiALLO therapy is designed to be suitable for all 1.7 million patients with HFrEF, providing a broader treatment option [24]. - The ongoing CardiAMP HF trial has a statistical power of over 90% to meet its primary endpoint based on interim results [38]. - The allogeneic MSC therapy for ischemic heart failure has received FDA approval for a Phase I/II trial, with initial dosing showing no adverse events [44]. - The CardiAMP Cell Therapy System has received Medicare national coverage, with costs covered up to $20,000 for both treatment and control, significantly reducing trial costs [41]. Market Opportunity - The American Heart Association estimates that the total cost of heart failure will increase from $30.7 billion in 2012 to $69.8 billion by 2030, indicating a growing market opportunity [21]. - Approximately 1.7 million patients in the U.S. have HFrEF, with an estimated 70% qualifying for treatment with the CardiAMP Cell Therapy [24]. - The company aims to address the significant burden of chronic angina, with an estimated 600,000 to 1.8 million patients in the U.S. suffering from CMI [25]. Clinical Trial Results - Interim results from July 2023 showed a 37% relative risk reduction in all-cause heart death equivalents and a 9% relative risk reduction in non-fatal heart attacks, strokes, and heart failure hospitalizations over a mean follow-up of 20 months [35]. - In a subgroup analysis, patients with elevated NTproBNP experienced an 86.2% relative risk reduction in heart death equivalents compared to control patients [36]. - The CardiAMP Phase III trial enrolled 125 patients across 18 centers in the U.S. and Canada, with a primary endpoint based on a composite score of serious events including all-cause death and non-fatal Major Adverse Coronary and Cerebrovascular Events (MACCE) [33]. Regulatory Environment - The FDA has never approved a cell-based therapy product intended to treat the heart, indicating a significant regulatory hurdle for the company [67]. - The process for FDA approval involves multiple phases, including nonclinical tests, submission of an IND application, and completion of clinical trials, which require substantial time and financial resources [69]. - The FDA aims to complete its review of 90% of standard BLAs within ten months and 90% of priority BLAs within six months from filing [88]. - The FDA may grant deferrals for submission of data or full or partial waivers for BLAs, impacting the approval timeline [81]. - The Fast Track program allows for rolling review of marketing applications, expediting the process for drugs addressing serious conditions [89]. - The approval of a BLA may be limited to specific diseases and dosages, affecting the commercial value of the product [87]. - The FDA requires a 12-year exclusivity period for biosimilars from the date of first licensure of the reference product, with a potential 4-year delay for application submission [100]. Financial Performance - The net loss for the year ended December 31, 2023, was $11.6 million, with an accumulated deficit totaling $152.2 million [164]. - The company does not anticipate generating revenues from sales of its cell therapy systems or any other biotherapeutic candidates within the next few years [166]. - The company has a history of operating losses and may not achieve profitability in the near future, which could impact its market value and ability to raise capital [168]. - The company is dependent on additional public or private financings to fund its operations, with substantial doubt about its ability to continue as a going concern [168]. Competition and Market Risks - The company faces intense competition in the biotechnology and pharmaceutical industries, particularly in the development of cell-based and gene-based therapeutic products [63]. - The company faces substantial competition in the market, which may hinder its ability to successfully commercialize its therapeutic candidates [156]. - Regulatory approval processes can be costly, time-consuming, and unpredictable, potentially harming the company's business if approvals are delayed [158]. Compliance and Legal Risks - The company may face challenges under various federal and state laws targeting fraud and abuse in the healthcare industry, impacting marketing and sales strategies [129]. - Compliance with environmental protection laws is essential, as violations could lead to significant penalties and operational disruptions [133]. - The company is at risk of securities class action litigation, which could impact its financial condition [162]. Operational Challenges - The company relies on third parties for clinical trials and manufacturing, which may affect the ability to obtain regulatory approval and commercialize products [156]. - The company must comply with various foreign government regulations to market its products outside the United States, which may differ significantly from U.S. requirements [144]. - The company relies on a license and distribution agreement with Biomet Biologics, LLC, and any breach could adversely affect clinical development and commercialization strategies [200]. Future Outlook - The long-term viability of the company heavily relies on the successful development and commercialization of the CardiAMP Cell Therapy System, currently in a Phase III pivotal trial [180]. - Failure to complete the ongoing Phase III trial of CardiAMP in heart failure could significantly impair financial results and delay regulatory approval [181]. - The company anticipates needing substantial additional financing to achieve its goals, which may impact product development and commercialization efforts [155].

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 ...