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 Q2 2023

Earnings data Q3 2023

Earnings data Q4 2023

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. 04, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today the successful completion of a consultation with Japan's Pharmaceutical and Medical Device Agency (PMDA) on the next steps for the submission for registration of its lead therapeutic asset, BCDA-01, for the treatment of ischemic heart failure of reduced ejection fraction (HFrEF).

BioCardia Announces Positive Consultation with Japan PMDA on CardiAMP Cell Therapy for Ischemic Heart Failure

BioCardia, Inc. (NASDAQ:BCDA ) Q3 2024 Earnings Conference Call November 13, 2024 4:30 PM ET Company Participants Miranda Peto - Investor Relations Peter Altman - President and CEO David McClung - Chief Financial Officer Conference Call Participants Joe Pantginis - H.C. Wainwright Kumar Raja - Brookline Capital Markets Operator Good afternoon, ladies and gentlemen.

BioCardia, Inc. (BCDA) Q3 2024 Earnings Call Transcript

SUNNYVALE, Calif., Sept. 18, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today that the Company has regained full compliance with the Nasdaq Capital Market's Listing Requirements as required by the Hearing Panel's (the “Panel”) decision on May 13, 2024.

BioCardia Regains Full Compliance with Nasdaq Listing Requirements

SUNNYVALE, Calif., Sept. 09, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the closing of its upsized public offering with participation from management and directors, institutional investors, and certain existing investors of the Company for the purchase and sale of 2,400,000 shares of common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to 2,400,000 shares of common stock at a combined offering price of $3.00 per share and accompanying warrant, priced at-the-market under Nasdaq rules. The company received aggregate gross proceeds of $7.2 million, before deducting placement agent fees and other offering expenses. The warrants have an exercise price of $3.00 per share, will be exercisable immediately and will expire five years from the issuance date.

BioCardia Announces Closing of Upsized $7.2 Million Public Offering Priced At-The-Market Under Nasdaq Rules

SUNNYVALE, Calif., Aug. 29, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today that the Food and Drug Administration (FDA) has cleared BioCardia to market the Morph DNA Steerable Introducer product family, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act.

BioCardia Announces FDA Market Clearance of Morph® DNA™ Steerable Introducer Product Family

BioCardia announced today that the FDA has approved an important protocol amendment for the CardiAMP Heart Failure II Trial, its confirmatory Phase 3 trial

FDA Approves CardiAMP® Heart Failure II Protocol Amendment to Use Proprietary Cell Population Analysis Screening to Define Treatment

BioCardia, Inc. (NASDAQ:BCDA ) Q2 2024 Earnings Conference Call August 13, 2024 4:30 PM ET Company Participants Miranda Peto - Investor Relations Peter Altman - President and CEO David McClung - Chief Financial Officer Conference Call Participants Joe Pantginis - H.C. Wainwright Laura Suriel - Alliance Global Partners Kevin Marshall - Innovative Financial Group Operator Ladies and gentlemen, thank you for standing by.

BioCardia, Inc. (BCDA) Q2 2024 Earnings Call Transcript

SUNNYVALE, Calif., Aug. 13, 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 second quarter of 2024 and filed its quarterly report on Form 10-Q for the three and six months ended June 30, 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 management's formal remarks, there will be a question-and-answer session.

BioCardia Reports Second Quarter 2024 Business Highlights and Financial Results

SUNNYVALE, Calif., July 17, 2024 (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 Unites States Patent Office has granted Patent No: 12,036,371 titled “Method of Accessing the Left Atrium with a Multi-Directional Steerable Catheter,” with a patent term that will expire in 2035.

BioCardia Announces United States Patent Issuance on Morph DNA Multi-Directional Steerable Catheter Transseptal Application

BioCardia announces that the USPTO has granted Patent No: 11,986,611 titled “Radial and Transendocardial Delivery Catheter,” with a 2036 expiration date.

BioCardia Announces United States Patent Issuance on Intramyocardial Delivery of Cell Aggregates to the Heart Including Minimally Invasive Radial Artery Approach

SUNNYVALE, Calif., May 21, 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 that, following approval by the Company's stockholders and its Board of Directors, the Company intends to effect a reverse stock split of its common stock at a ratio of 1 post-split share for every 15 pre-split shares. The reverse stock split will become effective at 12:01 a.m. Eastern Daylight Time on Thursday, May 30, 2024. The Company's common stock will begin trading on a split-adjusted basis when the market opens on Thursday, May 30, 2024. The Company's common stock and warrants will continue to be traded on The Nasdaq Capital Market under the ticker symbols “BCDA” and “BCDAW,” respectively. The reverse stock split is intended to increase the minimum bid price requirement for continued listing on The Nasdaq Capital Market. The Company, however, cannot assure that the price of its common stock after the reverse stock split will reflect the corresponding split ratio, that the price per share following the effective time will be maintained for any period of time, or that the price will remain above the pre-split trading price.

BioCardia Announces Reverse Stock Split

BioCardia, Inc. (NASDAQ:BCDA ) Q1 2024 Earnings Conference Call May 14, 2024 4:30 PM ET Company Participants Miranda Peto - IR Peter Altman - President and CEO David McClung - CFO Conference Call Participants Lander Egaña-Gorroño - H.C. Wainwright Operator Ladies and gentlemen, thank you for standing by.

BioCardia, Inc. (BCDA) Q1 2024 Earnings Call Transcript

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 management's formal remarks, there will be a question-and-answer session.

BioCardia Reports First Quarter 2024 Business Highlights and Financial Results

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.

BioCardia to Host Q1 2024 Financial Results and Corporate Update Conference Call on May 14, 2024

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.

BioCardia's CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial Results Show Patient Benefits in Important Outcomes

Call Scheduled for Study Clinical Leadership to Discuss Results and Details on Pivotal Randomized Trial Call Scheduled for Study Clinical Leadership to Discuss Results and Details on Pivotal Randomized Trial

BioCardia Completes Enrollment of CardiAMP Cell Therapy for the Treatment of Chronic Myocardial Ischemia Trial Open Label Roll-In Cohort

BioCardia, Inc. (BCDA) Q4 2023 Earnings Call Transcript

SUNNYVALE, Calif., March 27, 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 year ended December 31, 2023 and filed its annual report on Form 10-K with the Securities and Exchange Commission.

BioCardia Reports Fourth Quarter and Full Year 2023 Business Highlights and Financial Results

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.

BioCardia to Host 2023 Financial Results and Corporate Update Conference Call on March 27, 2024

BioCardia & StemCardia biotechnology company partnership targets heart failure, the leading cause of death and a condition with limited treatment options

BioCardia and StemCardia Announce Biotherapeutic Delivery Partnership

Centers for Medicare & Medicaid Services (CMS) approves reimbursement coverage of the confirmatory Phase III clinical trial of CardiAMP heart failure study

BioCardia Announces CMS Approval of Coverage for CardiAMP Cell Therapy Confirmatory Phase III Heart Failure Study

SUNNYVALE, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. (Nasdaq: BCDA), a biotechnology company focused on advancing late-stage cell therapy interventions for cardiovascular disorders, today announced positive interim results from the Phase III randomized controlled trial of its CardiAMP®  autologous cell therapy in 110 randomized patients with advanced chronic heart failure at a mean 20-month follow-up, (CardiAMP HF). Results showed reductions in heart death equivalents and MACCE, with a magnified reduction among patients with elevated NTproBNP, a common marker of heart distress. The data was presented today by Amish Raval, MD, Director of Clinical Cardiovascular Research and Professor of Medicine at the University of Wisconsin-Madison at the Technology and Heart Failure Therapeutics (THT) 2024 annual meeting.

BioCardia Reports Positive Interim Results from Phase III CardiAMP Cell Therapy Heart Failure Trial, with Compelling Data in Subgroup with Elevated NTproBNP Biomarker for Heart Failure

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.

BioCardia Announces Activation of CardiAMP Heart Failure II Phase 3 Pivotal Study Recently Approved by FDA

SUNNYVALE, Calif., Jan. 31, 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.

BioCardia Announces Two Scientific Abstracts Have Been Accepted at the 2024 Technology and Heart Failure Therapeutics Conference

SUNNYVALE, Calif., Jan. 03, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. (Nasdaq: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, issues the following letter to shareholders:

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