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BioCardia, Inc. (BCDA)

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Previous Close3.8800
Open3.8500
Bid0.0000 x 1000
Ask0.0000 x 800
Day's Range3.8200 - 4.0930
52 Week Range1.9100 - 8.6000
Volume151,555
Avg. Volume4,172,688
Market Cap56.424M
Beta (5Y Monthly)2.08
PE Ratio (TTM)N/A
EPS (TTM)-1.8270
Earnings DateNov 10, 2020
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est12.88
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  • BioCardia Signs Agreement With Leading Japanese Pharmaceutical Company for Catheter Biotherapeutic Delivery Product Candidates
    GlobeNewswire

    BioCardia Signs Agreement With Leading Japanese Pharmaceutical Company for Catheter Biotherapeutic Delivery Product Candidates

    SAN CARLOS, Calif., Feb. 23, 2021 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], today announced that it has entered into an agreement with a leading Japanese pharmaceutical company related to BioCardia Helix catheter biotherapeutic delivery product candidates. Under the terms of the agreement, BioCardia will receive a $500,000 up-front payment, a portion of which is creditable for biotherapeutic delivery products and support services. The agreement has a one-year term with an option to negotiate for a non-exclusive world-wide license to BioCardia Helix catheter biotherapeutic delivery product candidates for certain cell types for cardiac indications. “Our collaboration with this leading Japanese pharmaceutical company further validates our core Helix biotherapeutic delivery technology as the leading delivery platform for local cell, gene and protein-based therapy to the heart. To our knowledge, the Helix system is currently the only intra-myocardial delivery system in clinical use worldwide. We are grateful for the additional recognition of the Helix system’s potential to enable the successful development of others’ therapies,” said BioCardia CEO Peter Altman, Ph.D. “Recent publications have demonstrated our Helix delivery platform is the most efficient(1), and has the best clinical performance(2). These Helix system advantages are believed to underlie our recently reported CardiAMP™ cell therapy clinical results in heart failure (3). We look forward to bringing all of our experience and delivery technologies to bear to help advance this partner’s important therapeutic development efforts.” BioCardia, Inc., headquartered in San Carlos, California, is developing regenerative biologic therapies to treat cardiovascular and respiratory disease. CardiAMP autologous and Neurokinin-1 Receptor Positive allogenic cell therapies are the Company’s biotherapeutic platforms in clinical development. The Company's products include the Helix Biotherapeutic Delivery System and its steerable guide and sheath catheter portfolio. BioCardia also partners with other biotherapeutic companies to provide its Helix system and clinical support for their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia, and acute myocardial infarction. For more information, visit www.BioCardia.com. Forward Looking Statements:This press release contains forward-looking statements that are subject to risks and uncertainties. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. These forward-looking statements reflect our view as of the time such statement is made and are not guarantees of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. Mitsutake Y, Pyun WB, Rouy D, et al. Improvement of local cell delivery using Helix transendocardial delivery catheter in a porcine heart. Int Heart J. (2017). Raval AN, Pepine CJ. Clinical safety profile of transendocardial catheter injection systems: A plea for uniform reporting. Cardiovascular Revascularization Medicine (2020).Raval AN, Johnston PV, Duckers HJ, et al. Point of care, bone marrow mononuclear cell therapy in ischemic heart failure patients personalized for cell potency: 12-month feasibility results from CardiAMP heart failure roll-in cohort, Int J. Cardiology (2020). INVESTOR CONTACT:David McClung, Chief Financial Officerinvestors@BioCardia.com(650) 226-0120 MEDIA CONTACT:Michelle McAdam, Chronic Communications, Inc.michelle@chronic-comm.com(310) 545-6654

  • BioCardia Announces Clinical Leadership Changes
    GlobeNewswire

    BioCardia Announces Clinical Leadership Changes

    SAN CARLOS, Calif., Feb. 17, 2021 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA] a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced clinical leadership changes. Dr. Sujith Shetty who has been with the Company for almost two years in the capacity of Vice President of Clinical and Regulatory will assume the role of Chief Medical Officer, replacing Dr. Eric Duckers, who resigned as Chief Medical Officer of the Company to pursue other opportunities, effective as of February 15th, 2021. Simultaneous with his resignation, Dr. Duckers entered into a consulting agreement to continue to provide support for the ongoing CardiAMP Heart Failure Trial and its leadership team. Ms. Debby Holmes-Higgin who has been with the Company for more than three years will continue to serve as Vice President of Clinical with expanded responsibilities. Both Dr. Shetty and Ms. Holmes-Higgin will be supported by Dr. Hans-Peter Stoll, who recently assumed the role of consulting Medical Monitor for the CardiAMP clinical study. Dr. Stoll has extensive clinical experience having been most recently the Chief Medical Officer at Biosensors International, GE Healthcare, and Cordis, Johnson & Johnson. “Evolution of the clinical team after the recent successful Data Safety Monitoring Board Review of the CardiAMP Heart Failure Trial is an important step for the success of the ongoing trial,” said Peter Altman, Ph.D., BioCardia’s President and CEO. “Dr. Shetty and Ms. Holmes-Higgin are world class executives in whom we have every confidence, and I am delighted that they will be supported both by Dr. Stoll as Medical Monitor and Dr. Duckers on a consulting basis.” About BioCardia® BioCardia, Inc., headquartered in San Carlos, California, is developing regenerative biologic therapies to treat cardiovascular and respiratory disease. CardiAMP autologous and Neurokinin-1 Receptor Positive allogenic cell therapies are the Company’s biotherapeutic platforms in clinical development. The Company's products include the Helix Biotherapeutic Delivery System and its steerable guide and sheath catheter portfolio. BioCardia also partners with other biotherapeutic companies to provide its Helix system and clinical support for their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia, and acute myocardial infarction. For more information, visit www.BioCardia.com. Forward Looking Statements:This press release contains forward-looking statements that are subject to risks and uncertainties. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. These forward-looking statements reflect our view as of the time such statement is made and are not guarantees of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. INVESTOR CONTACT:David McClung, Chief Financial Officerinvestors@BioCardia.com(650) 226-0120 MEDIA CONTACT:Michelle McAdam, Chronic Communications, Inc.michelle@chronic-comm.com(310) 545-6654

  • BioCardia Update on Cell Therapy Product Development and 2021 Milestones
    GlobeNewswire

    BioCardia Update on Cell Therapy Product Development and 2021 Milestones

    SAN CARLOS, Calif., Feb. 02, 2021 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA] a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today provides an update on its cell therapy product development and 2021 milestones. BCDA-01, our CardiAMP autologous cell therapy under Phase III clinical development for the treatment of ischemic heart failure remains the Company’s top priority. The Company is targeting completion of enrollment without requiring additional financing. The trial is expected to have its next prespecified independent Data Safety Monitoring Board review in early Q3 2021.BCDA-02, our CardiAMP autologous cell therapy is under Phase III development for the treatment of chronic myocardial ischemia. First patient enrolled in the trial is expected in Q1 with roll in cohort safety data in 2021.BCDA-03, our allogenic neurokinin 1 receptor positive (NK1R+) Mesenchymal Stem Cell (MSC) Phase I/II program follows previous Phase I/II clinical development work with MSCs for the treatment of ischemic heart failure and is intended initially for those patients excluded from BCDA-01. In recent Investigational New Drug (IND) application submission interactions for this program, the FDA has indicated comfort regarding the pharmacology and toxicology and with the clinical plan but had continued questions related to our chemistry, manufacturing, and controls (CMC). We are working to resolve the outstanding issues with the agency to enable us to move forward with the NK1R+ MSC program and target IND acceptance in 2021.BCDA-04, our allogenic NK1R+ MSC Phase I/II program for the treatment of acute respiratory distress resulting from COVID-19 is on a similar timeline to our BCDA-03 program as it utilizes substantially the same CMC. New strains of COVID-19 may enhance the importance of this therapeutic program and we target IND acceptance in 2021. “This is a big year ahead for BioCardia as we advance our two pivotal autologous cell therapy cardiac programs and ramp manufacturing activities for our allogenic cell therapy programs,” said Peter Altman, Ph.D., BioCardia’s CEO. “Recent results in the field have enhanced recognition for our technological and strategic approach to autologous cardiac cell therapy with the CardiAMP Cell Potency Assay to reduce patient variability, trial designs targeting patient populations sick enough to benefit greatly but not so ill that comorbidities drive outcomes, and the use of our leading Helix transendocardial biotherapeutic delivery system for enhanced dosage efficiency. The Helix system, used in all three of our cardiac programs, is also anticipated to see greater usage by partners in the year ahead.” About BioCardia BioCardia, Inc., headquartered in San Carlos, California, is developing regenerative biologic therapies to treat cardiovascular and respiratory disease. CardiAMP autologous and Neurokinin-1 Receptor Positive allogenic cell therapies are the Company’s biotherapeutic platforms in clinical development. The Company's products include the Helix Biotherapeutic Delivery System and its steerable guide and sheath catheter portfolio. BioCardia also partners with other biotherapeutic companies to provide its Helix system and clinical support for their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia, and acute myocardial infarction. For more information, visit www.BioCardia.com. Forward Looking StatementsThis press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses, or current expectations. Forward-looking statements include, without limitation, statements relating to study enrollment expectations, the timing and intended outcomes of our trials, the efficacy and safety of our products and therapies, the timeline for and acceptance of our INDs by the FDA, the expectation of greater usage of the Helix system by our partners, the likelihood of success and the value of our clinical cell therapy programs and the sufficiency of capital to pursue BioCardia’s business and product development plans and achieve anticipated milestones. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardia’s business and product development plans and overall market conditions. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in our documents filed with the Securities and Exchange Commission, including our recent filings on Form 8-K, Form 10-K and Form 10-Q, particularly any statements under the caption entitled “Risk Factors” Therein. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. INVESTOR CONTACT:David McClungChief Financial Officerinvestors@BioCardia.com(650) 226-0120 MEDIA CONTACT:Michelle McAdamChronic Communications, Inc.michelle@chronic-comm.com(310) 545-6654