BioCardia Inc.

BioCardia, Inc. operates as a clinical-stage regenerative medicine company. It develops novel therapeutics for cardiovascular diseases. The firm offers proprietary comprehensive biotherapeutic solutions for cardiovascular disease under the CardiAMP and CardiALLO brands. It operates in only one business segment, which is a clinical-stage regenerative medicine company developing novel therapeutics for cardiovascular diseases with large unmet medical needs. The company was founded on January 12, 1994 and is headquartered in Sunnyvale, CA.

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Earnings data Q1 2024

Earnings data Q2 2024

Earnings data Q3 2024

Earnings data Q4 2024

BioCardia reports successful fiscal year with promising clinical trials

BioCardia Inc. had a strong fiscal year with positive clinical trial results and increased revenues. While facing challenges related to trial data and timelines, the company's diversified product pipeline and financial stability offer growth opportunities in the healthcare sector.

BioCardia advances cell therapy programs amidst financial challenges and opportunities

BioCardia's Q1 2023 performance reflects ongoing investment in innovative cell therapy platforms. While facing financial challenges, the company remains focused on advancing clinical trials and engaging with regulatory authorities. Opportunities exist for BioCardia to leverage its expertise in cell therapy for strategic partnerships and further development.

BioCardia reports Q2 progress amidst trial setback and regulatory advancements

BioCardia's Q2 performance reflects progress in cell therapy platforms and regulatory advancements.
While facing challenges with the CardiAMP trial pause, the company maintains transparency and commitment to stakeholders.
Opportunities lie in addressing trial concerns, improving financial performance, and expanding market reach.

BioCardia reports Q3 results, progresses in cell therapy trials

BioCardia's Q3 performance reflects a mix of financial challenges and promising advancements in cell therapy trials for cardiovascular diseases.
Despite setbacks like the pause in the CardiAMP trial, the company's strategic initiatives and focus on regulatory approvals signal resilience and growth potential.
With a proactive approach to trial modifications and business development, BioCardia aims to leverage opportunities for future success in the biotech sector.

BioCardia reports positive trial data and strategic growth initiatives

BioCardia's Q4 2023 earnings call highlighted positive trial data, financial performance, strategic partnerships, and regulatory advancements, positioning the company for future growth.
While facing challenges in funding, timelines, and regulatory compliance, BioCardia's focus on innovation and market expansion presents opportunities for long-term success.
Investors should monitor BioCardia's progress in advancing its cell therapy platforms, securing approvals, and navigating regulatory landscapes for insights into its growth trajectory.

BioCardia reports positive trial results and financial improvements in Q1

BioCardia's Q1 2024 performance showcased positive trial results and improved financials, setting the stage for potential regulatory submissions and commercialization strategies.
While facing challenges in regulatory discussions and trial advancements, the company remains poised to capitalize on opportunities for growth and expansion.

BioCardia reports positive Q2 earnings, advances heart failure treatments

BioCardia demonstrated improved financial performance and significant advancements in clinical trials and product development, positioning the company for future growth
While facing challenges in regulatory compliance and financial sustainability, BioCardia's strengths in innovative treatments and partnership opportunities offer avenues for expansion
The company's focus on achieving key milestones like FDA clearances and trial completions underscores its commitment to advancing cardiovascular therapies and enhancing shareholder value

BioCardia reports strong Q3 performance, eyes partnerships for growth

BioCardia's Q3 2024 performance reflects improved financials and promising advancements in their lead cell therapy programs for heart failure
The company's strengths lie in efficient capital management, pipeline progress, and successful fundraising activities, positioning them for future growth
Challenges include clinical trial outcomes, regulatory hurdles, and balancing R&D momentum with cost management, while opportunities exist in partnerships and market expansion

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BioCardia, Inc. is a clinical-stage biotherapeutic company. It engages in the business of developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases with significant unmet medical needs. The company was founded on January 12, 1994 and is headquartered in Sunnyvale, CA.

SUNNYVALE, Calif., Dec. 19, 2023 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease, today announced that the first patient was enrolled and treated in its CardiALLO™ Allogeneic Mesenchymal Cell Therapy Phase I/II trial for the treatment of patients with New York Heart Association Class II and III ischemic heart failure of reduced ejection fraction (HFrEF).

BioCardia Doses First Patient in CardiALLO Phase I/II Clinical Trial of BCDA-03 Allogeneic Mesenchymal Stem Cells for the Treatment of Ischemic Heart Failure of Reduced Ejection Fraction

SUNNYVALE, Calif., Dec. 18, 2023 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that Japan Pharmaceutical and Medical Device Agency (PMDA) minutes support the Company's understanding that CardiAMP autologous cell therapy may be approved for the treatment of patients with ischemic heart failure with reduced ejection fraction (HFrEF) based on follow-up data from the patients currently enrolled in the CardiAMP Heart Failure Trial (CardiAMP HF) that will be available in Q4 2024.

BioCardia Announces Expected CardiAMP Heart Failure Japan Approval Timeline Based on Pharmaceutical and Medical Device Agency Consultation Minutes

SUNNYVALE, Calif., Nov. 29, 2023 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today provided an update after its recent consultation with Japan's Pharmaceutical and Medical Device Agency (PMDA) towards approval of its CardiAMP autologous cell therapy for the treatment of patients with ischemic heart failure of reduced ejection fraction (HFrEF).

BioCardia Shares Update from Japan PMDA Consultation on CardiAMP Autologous Cell Therapy for Ischemic Heart Failure; Foreign Data Expected to be Sufficient for Product Approval

SUNNYVALE, Calif., Nov. 16, 2023 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA] (the “Company”), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that it has entered into a definitive agreement with a single healthcare-focused institutional investor for the purchase and sale of 2,000,000 shares of the Company's common stock at a purchase price of $0.65 per share of common stock in a registered direct offering priced at-the-market under Nasdaq rules. The closing of the offering is expected to occur on or about November 20, 2023, subject to the satisfaction of customary closing conditions.

BioCardia Announces $1.3 Million Registered Direct Offering of Common Stock Priced At-the-Market under Nasdaq Rules

The FDA approves BioCardia's (BCDA) phase III study on its CardiAMP cell therapy to treat patients with ischemic heart failure.

BioCardia (BCDA) Soars 168% on FDA Nod to Heart Failure Study

SUNNYVALE, Calif., Nov. 14, 2023 (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 Food and Drug Administration (FDA) approval of its Phase III clinical trial of its CardiAMP autologous cell therapy for the treatment of patients with ischemic heart failure.

BioCardia Announces FDA Approval of CardiAMP Heart Failure II Protocol for Autologous Cell Therapy for Ischemic Heart Failure

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.

BioCardia, Inc. (BCDA) Q3 2023 Earnings Call Transcript

BioCardia, Inc. (BCDA) came out with a quarterly loss of $0.12 per share in line with the Zacks Consensus Estimate. This compares to loss of $0.17 per share a year ago.

BioCardia, Inc. (BCDA) Reports Q3 Loss, Tops Revenue Estimates

SUNNYVALE, Calif., Nov. 08, 2023 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reports financial results for the third quarter of 2023 and filed its quarterly report on Form 10-Q for the three and nine months ended June 30, 2023 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 management's formal remarks, there will be a question-and-answer session.

BioCardia Reports Third Quarter 2023 Business Highlights and Financial Results

SUNNYVALE, Calif., Nov. 01, 2023 (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 provide a corporate update and report its financial results for the three and nine months ended September 30, 2023 by conference call on Wednesday, November 8, 2023 at 4:30 PM ET. Following management's formal remarks, there will be a question-and-answer session.

BioCardia to Host Q3 2023 Corporate Update and Financial Results Conference Call on November 8, 2023

BioCardia (BCDA) completes enrollment in a pivotal phase III study on its CardiAMP cell therapy for the treatment of heart failure. It plans to begin a second study with responders from the initial study.

BioCardia (BCDA) Up on Plans for Second Heart Failure Study

SUNNYVALE, Calif., Oct. 11, 2023 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease, today announces completion of enrollment in its CardiAMP Heart Failure Trial and initiation of a discussion with the FDA on a second pivotal study protocol adapted for the responders in the initial trial with the objective of gaining FDA marketing approval.

BioCardia Announces Completion of Enrollment in Phase III CardiAMP HF Trial and Plans for CardiAMP HF Trial II

Based on one-year follow-up data from a pivotal phase III study, BioCardia (BCDA) reveals that its CardiAMP cell therapy is unlikely to achieve the primary endpoint for the treatment of heart failure.

BioCardia (BCDA) Dips 26% on Flunking Heart Failure Study

SUNNYVALE, Calif., Sept. 06, 2023 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease, today announced a clarification and next steps on its autologous CardiAMP cell therapy programs.

BioCardia Announces Clarification and Next Steps on its Autologous CardiAMP Cell Therapy Programs

BioCardia shares fell more than 20% in pre-market trade on Tuesday after the biopharmaceutical firm revealed that its Phase 3 trial of CardiAMP cell therapy for heart failure was unlikely to meet its three-tiered primary efficacy endpoint based on interim trial results. CardiAMP cell therapy uses a patient's own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body's natural healing response.

BioCardia shares slide on disappointing interim data from heart therapy trial

SUNNYVALE, Calif., Sept. 05, 2023 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease, today announced it has finalized external review of interim data and evaluated interim efficacy results for the ongoing Phase III pivotal trial of CardiAMP ®  Cell Therapy for Heart Failure (CardiAMP HF, clinicaltrials.gov Identifier: NCT02438306), for which the FDA granted Breakthrough Designation for the treatment of heart failure of reduced ejection fraction (HFrEF).

BioCardia Announces Interim Efficacy Results in Phase III Pivotal CardiAMP Cell Therapy Heart Failure Trial

BioCardia, Inc. (BCDA) came out with a quarterly loss of $0.17 per share versus the Zacks Consensus Estimate of a loss of $0.15. This compares to loss of $0.14 per share a year ago.

BioCardia, Inc. (BCDA) Reports Q2 Loss, Lags Revenue Estimates

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.

BioCardia, Inc. (BCDA) Q2 2023 Earnings Call Transcript

SUNNYVALE, Calif., Aug. 09, 2023 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reports financial results for the second quarter of 2023 and filed its quarterly report on Form 10-Q for the three and six months ended June 30, 2023 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 management's formal remarks, there will be a question-and-answer session.

BioCardia Reports Second Quarter 2023 Business Highlights and Financial Results

SUNNYVALE, Calif., Aug. 02, 2023 (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 three and six months ended June 30, 2023 and provide a corporate update by conference call on Wednesday, August 9, 2023 at 4:30 PM ET. Following management's formal remarks, there will be a question-and-answer session.

BioCardia to Host Q2 2023 Financial Results and Corporate Update Conference Call on August 9, 2023

SUNNYVALE, Calif., July 24, 2023 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease, today announces that the independent Data Safety Monitoring Board (DSMB) has completed its prespecified data review for the ongoing Phase III pivotal  CardiAMP ®  Cell Therapy Heart Failure Trial (clinicaltrials.gov Identifier: NCT02438306), for which FDA granted Breakthrough Designation. Pursuant to the DSMB recommendation, BioCardia is pausing the trial pending the one-year follow-up outcomes analysis for patients that have been treated and those that have been enrolled but not yet treated.

BioCardia Announces DSMB Recommendation to Pause New Enrollment in Phase III Pivotal CardiAMP Cell Therapy Heart Failure Trial While Additional Blinded Data is Collected

SUNNYVALE, Calif. , July 05, 2023 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces it completed its submission of the CardiAMP Cell Therapy System to Japan's Pharmaceutical and Medical Device Agency (PMDA) towards approval for the indication of ischemic heart failure with reduced ejection fraction (HFrEF). The formal consultation with PMDA to review the submission is anticipated in approximately three months and will be BioCardia's third consultation with PMDA.

BioCardia Completes Submission of CardiAMP Cell Therapy System in Heart Failure to Japan's Pharmaceutical Medical Device Agency

SUNNYVALE, Calif., June 20, 2023 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that FDA Center for Biologics Evaluation and Research (CBER) has completed review of the CardiAMP Cell Therapy System adaptive statistical analysis design supplement for the ongoing pivotal study to treat ischemic heart failure with reduced ejection fraction (HFrEF). The adaptive statistical analysis plan is on track to be implemented at the upcoming Data Safety Monitoring Board (DSMB) meeting, scheduled for July 12, 2023.

BioCardia Announces FDA Completes Review of Proposed Adaptive Statistical Analysis Design for Ongoing CardiAMP Cell Therapy in Heart Failure Pivotal Study

SUNNYVALE, Calif., June 08, 2023 (GLOBE NEWSWIRE) -- BioCardia®, Inc.  [Nasdaq: BCDA], a company focused on cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases today announces that the Japan Patent Office has granted Patent No: JP7282649B2 titled “Radial and Transendocardial Delivery Catheter” with a patent term that will expire on September 30, 2034.

BioCardia Announces Helix™ Biotherapeutic Delivery Patent Issuance in Japan

SUNNYVALE, Calif., May 23, 2023 (GLOBE NEWSWIRE) -- BioCardia®, Inc.  [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases today announced that the next Data Safety Monitoring Board (DSMB) meeting for the CardiAMP Cell Therapy Trial for Heart Failure is scheduled to take place on July 12th. The Company expects the FDA's response to its adaptive statistical analysis plan supplement early to mid-June and anticipates approval of the plan and completion of all tasks to implement the plan, including all data monitoring, in advance of the DSMB meeting.

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