BioCardia Reports First Quarter 2020 Financial Results and Business Highlights
May 15, 2020
SAN CARLOS, Calif. – BioCardia®, Inc. [NASDAQ: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today reported financial results and business highlights for the first quarter of 2020 and filed its quarterly report on Form 10-Q for the three months ended March 31, 2020 with the Securities and Exchange Commission on May 15, 2020.
First Quarter 2020 Business Highlights:
- CardiAMP® Heart Failure Trial received positive review by Data Safety Monitoring Board - In March 2020, the independent DSMB completed a prespecified review and issued a positive recommendation to continue the Company’s Phase III pivotal CardiAMP Heart Failure Trial as planned, since they found no safety concerns. To date, 74 patients have been enrolled in the study at 25 world class centers throughout the U.S.
- FDA clearance received for guide catheter used in cell therapy delivery - The Company received FDA clearance for the Morph® DNA Deflectable Guide Catheter in January 2020. The Morph DNA is designed to enhance the procedural control of the Helix™ Biotherapeutic Delivery System during CardiAMP cell therapy delivery in the heart. The device is designed to be virtually whipless around curves, offer bidirectional deflection within the heart, and further enhance both control and ease of use for physicians.
- Three new patents granted in U.S. and Asia – Also in January 2020, the Company was issued three new patents. An additional U.S. patent now protects its proprietary cell potency assay used to identify candidates for CardiAMP cell therapy, in addition to an existing European patent. Japan and China both issued new patents covering the Company’s biotherapeutic delivery approaches using radial artery access for trans-endocardial delivery of cardiac cell therapy.
“We have started the year off well by achieving key regulatory and clinical milestones and adding to our already-strong intellectual property portfolio,” said BioCardia Chief Executive Officer Peter Altman, PhD. “While CardiAMP Heart Failure Trial cases have been paused as clinical sites care for COVID-19 patients, sites continue to screen candidates and there are patients scheduled for treatment in the second quarter as centers resume elective procedures.”
First Quarter 2020 Financial Results:
- Net loss was $4.6 million for the first quarter of 2020 compared to $3.7 million in the first quarter of 2019.
- Research and development expenses were $2.8 million in the first quarter of 2020 compared to $2.2 million in the first quarter of 2019, primarily due to expenses incurred while conducting the pivotal CardiAMP Heart Failure Trial, development of the CardiALLO™ Cell Therapy System and our other therapeutic programs.
- Selling, general and administrative expenses for the first quarter of 2020 totaled $1.9 million, compared to $1.6 million in the first quarter of 2019, primarily due to increased stock compensation expenses, including a repricing of stock options in January 2020.
- Net cash used in operations in the first quarter of 2020 was $3.0 million compared to $2.5 million in the first quarter of 2019.
Anticipated Upcoming Milestones:
- Q2 2020: Phase III pivotal trial commencement and first sites activated in CardiAMP Chronic Myocardial Ischemia (CMI) Trial (BCDA-02)
- Q2 2020: FDA acceptance of Investigational New Drug application for CardiALLO Neurokinin-1 Receptor Positive Mesenchymal Stem Cell Therapy (BCDA-03), the Company’s second therapeutic platform, for the treatment of ischemic heart failure.
- Q4 2020: Pre-specified Data Safety Monitoring Board Review of all patients enrolled, including futility analysis, based on sixty (60) patients that will have reached the primary one-year follow-up endpoint at the time of analysis (BCDA-01)
- Q4 2020: Pre-specified Data Safety Monitoring Board Review of safety data from roll-in cohort in CardiAMP CMI Trial (BCDA-02)
- Q4 2020: FDA acceptance of Investigational New Drug application for Neurokinin-1 Receptor Positive Mesenchymal Stem Cell Therapy (BDCA-04) for the treatment of Acute Respiratory Distress Syndrome as a result of COVID-19
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 approved products include the Helix transendocardial 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 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 availability of data from our clinical trials, filings with the FDA, FDA product clearances, the efficacy and safety of our products and therapies, statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. 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. We may find it difficult to enroll patients in our clinical trials due to many factors, some of which are outside of our control. Slower than targeted enrollment could delay completion of our clinical trials and 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 April 9, 2020, under the caption titled “Risk Factors.” BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
Michelle McAdam, Chronic Communications, Inc.
David McClung, Chief Financial Officer
Henry Ford Health System
Cell & Gene
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