BioCardia, Inc. Reports Fourth Quarter 2017 Financial Results and Business Highlights

SAN CARLOS, Calif.–(BUSINESS WIRE)–BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, announced it filed its annual 10-K for the year ended December 31, 2017 with the Securities and Exchange Commission on Friday, March 16, 2018.

BioCardia reported a net loss of $12.3 million in 2017, which compares to a net loss of $10.3 million in 2016. Research and development expenses increased by $2.5 million, from $3.3 million in 2016 to $5.8 million in 2017, primarily due to increased expenses incurred in conducting the first pivotal trial of its lead therapeutic candidate, the CardiAMP Cell Therapy System for the heart failure indication (CardiAMP Heart Failure Trial). Selling, general and administrative expenses increased $2.3 million, from $4.1 million in 2016 to $6.4 million in 2017, primarily due to additional costs for the organizational structure needed to support its development activities and the Company’s first full year of operations as a public company. Net cash used in operations increased from $5.5 million in 2016 to $8.7 million in 2017.

The Company’s investigational CardiAMP Cell Therapy System is intended to provide a comprehensive biotherapeutic solution for the two indications of heart failure and chronic myocardial ischemia. The system incorporates a proprietary biomarker screening test to select patients most likely to respond to therapy, a point of care processing platform to prepare cells at the patient’s bedside and a highly efficient delivery system that easily navigates a patient’s vasculature to securely deliver cells in a standard cardiac catheterization procedure.

• The ongoing pivotal CardiAMP Heart Failure Trial is approved to enroll up to 260 patients at up to 40 centers. This follows compelling data from the published Phase I open label and Phase II randomized placebo-controlled trials of CardiAMP therapy. The pivotal Phase III trial is currently enrolling at 10 world class centers in the United States. Safety and efficacy data from the open label roll-in cohort patients at three, six, nine and 12-month follow-up will be available in 2018. The trial is expected to complete enrollment in the second quarter of 2019. The Center for Medicare and Medicare Services (CMS) has designated that this trial qualifies for Medicare reimbursement, which significantly reduces the overall development costs of this program.
• The CardiAMP Chronic Myocardial Ischemia Trial is approved to enroll up to 343 patients, also at 40 centers in the United States. An application to CMS for the same reimbursement designation has been submitted and the Company anticipates a decision in April 2018.

BioCardia Chief Executive Officer, Dr. Peter Altman said, “We believe our approach has great potential to positively impact the lives of millions of patients suffering from ischemic heart failure and chronic myocardial ischemia. Our clinical trials are designed to demonstrate that by selecting patients based on the characteristics of their own stem cells and preparing and delivering those cells in a high dosage using our delivery platform, they will be more likely to respond favorably to therapy. This differentiates the CardiAMP Cell Therapy from other approaches in the field.”

About BioCardia®

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, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this presentation. As a result of these factors, we cannot assure you that the forward-looking statements in this presentation 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 30, 2017, 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.