Financial 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].

SUNNYVALE, Calif., May 14, 2024 (GLOBE NEWSWIRE) -- 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 first quarter of 2024 and filed its quarterly report on Form 10-Q for the three months ended March 31, 2024 with the Securities and Exchange Commission. The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights. Following ...

SUNNYVALE, Calif., May 09, 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 the three months ended March 31, 2024 and provide a corporate update by conference call on Tuesday, May 14, 2024 at 4:30 PM ET. Following management's formal remarks, there will be a question-and-answer session. Participants can register for the confere ...

SUNNYVALE, Calif., May 01, 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 the primary endpoint results of the open label roll-in cohort of the CardiAMP® Cell Therapy in Chronic Myocardial Ischemia Trial. Study clinical cardiology leadership and members of the Executive Steering Committee, Dr. Carl Pepine, Professor of Medicine at the University Florida at Gainesville, an ...

SUNNYVALE, Calif., April 25, 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 completion of enrollment and collection of the primary endpoint results of the open label roll-in cohort of the CardiAMP® Cell Therapy in Chronic Myocardial Ischemia Trial. The Company will report results from this trial and host a call with study clinical cardiology leadership to review the oppo ...

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 ...