BioCardia, Inc. Reports First Quarter 2018 Financial Results and Business Highlights
May 11, 2018
SAN CARLOS, Calif. –BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, filed its 10-Q for the three months ended March 31, 2018 with the Securities and Exchange Commission.
First Quarter 2018 Financial Results:
- BioCardia reported a net loss of $3.6 million for the first quarter of 2018, which compares to a net loss of $2.9 million for the first quarter of 2017.
- Research and development expenses were $2.0 million in the first quarter of 2018 compared to $1.0 million in the first quarter of 2017, primarily due to expenses incurred while conducting the pivotal CardiAMP Heart Failure Trial.
- Selling, general and administrative expenses for the first quarter of 2018 totaled $1.7 million, a 5.4% decrease compared to $1.8 million in the first quarter of 2017.
- Net cash used in operations in the first quarter of 2018 was $3.0 million, an increase of $758,000, from $2.3 million in the first quarter of 2017.
2018 Corporate Highlights:
- The CardiAMP Heart Failure Trial is currently enrolling patients at 13 world class centers in the United States with Center for Medicare and Medicaid Services (CMS) National Reimbursement. The trial design was published in the American Heart Journal in April.
- The U.S. Food and Drug Administration approved a second pivotal Investigational Device Exemption trial for the CardiAMP Cell Therapy System for the treatment of chronic myocardial ischemia with refractory angina. CMS has approved this CardiAMP Chronic Myocardial Ischemia Trial for national reimbursement coverage.
- The Company received a new US Patent related to its CardiAMP cell potency assay, providing further protection to its autologous cell therapy programs in both heart failure and chronic myocardial ischemia indications.
BioCardia, Inc., headquartered in San Carlos, California, is developing regenerative biologic therapies to treat cardiovascular disease. CardiAMP™ and CardiALLO™ cell therapies are the Company’s biotherapeutic product candidates in clinical development. The Company's current products include the Helix™ transendocardial delivery system and the Morph® steerable guide and sheath catheter portfolio. BioCardia also partners with other biotherapeutic companies to provide its Helix systems and clinical support to their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction.
Forward Looking Statements
This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the enrollment of our clinical trials, the efficacy and safety of our products and therapies, statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such factors 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. We may find it difficult to enroll patients in our clinical trials, which could delay or prevent development of our therapeutic candidates. 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 BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 16, 2018, including under the caption titled “Risk Factors.” BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
David McClung, Chief Financial Officer
Henry Ford Health System
Cell & Gene
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