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SAN CARLOS, Calif., Nov. 10, 2020 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [NASDAQ: BCDA], a leader in the development of autologous and allogenic cell therapies, today reported financial results and business highlights for the third quarter of 2020 and filed its quarterly report on Form 10-Q for the three and nine months ended September 30, 2020 with the Securities and Exchange Commission on November 10, 2020.
The Company is advancing its autologous and allogenic bone marrow-derived cell therapies for three cardiovascular indications and one respiratory indication.
Third Quarter 2020 Business Highlights:
Autologous Cell Therapies
BCDA-01: Patient enrollment in the Phase III pivotal trial of the investigational CardiAMP® cell therapy for the treatment of heart failure continued as centers slowly emerge from the challenges related to COVID-19. As of today, 81 patients have been randomized, four patients are being scheduled for treatment after passing screening with the cell potency assay, and nine additional patients have recently been consented and are actively being screened. Clinical sites remain engaged and momentum is resuming for these elective enrollment activities. Data transfer for the DSMB review scheduled for December 15th has been completed. The anticipated DSMB review in the fourth quarter of 2020, including the risk benefit analysis of 60 patients at their primary endpoint, appears to be on track.
BCDA-02: A second clinical application of CardiAMP cell therapy for the treatment of chronic myocardial ischemia is also advancing in an FDA-approved pivotal trial, which is also being reimbursed by the Centers for Medicaid and Medicare Services (CMS). The Company began the third quarter by activating this trial at the University of Florida as the first clinical site. Four additional sites are in active contracting and budget negotiations. Enrollment of the first patient in this trial in the fourth quarter of 2020 appears to be on track.
Allogenic Cell Therapies
BCDA:03: Development continued in the CardiALLO™ neurokinin-1 receptor positive (NK1R+) mesenchymal stem cell (MSC) program targeted to treat patients with heart failure who are ineligible for the Company’s autologous cell therapy due to their cell potency assay score. After responding to FDA comments on the Investigational New Drug Application in the second quarter of 2020, the FDA raised additional questions related to long-term preclinical follow-up results. Of note, it appears that all questions on the clinical protocol and the chemistry manufacturing and controls have now been addressed to the agency’s satisfaction. The preclinical studies requested by the FDA have been completed and the data reports provided to the agency. The conclusion from these studies is that, following myocardial infarction, intramyocardial injection of the Company’s NK1R+ MSCs did not result in any significant observed treatment-related serious adverse events. Further, the investigational cells showed signs of efficacy in an animal disease model, with improved cardiac wall motion, fractional shortening, and cardiac output in both the low dose and the high dose cohorts at both 30-day and 90-day follow-up. The Company appears to be on track for acceptance of this IND by the FDA in the fourth quarter of 2020.
BCDA-04: Pre-clinical work to pursue a program with the NK1R+ MSC to treat acute respiratory distress developing from COVID-19 was also completed successfully with no significant observed product safety issues. The team is currently developing the IND submission which will rely significantly on the submission for BCDA-03. Acceptance of this IND by the FDA in the fourth quarter of 2020 remains possible if the Company completes its IND submission by the end of November 2020.
BioCardia was awarded U.S. Patent No: 10,780,248 for a “Radial and Transendocardial Delivery Catheter” that further protects the Helix™ Biotherapeutic Delivery System and enhances its cell therapy delivery capabilities. This patent provides additional broad protection for the Helix system, as well as for the three therapeutic programs that it enables.
“We are reaching critical milestones in our cardiovascular and respiratory cell therapy development programs at a time when patients are increasingly presenting with heart damage due to COVID-19,” said BioCardia CEO Peter Altman, PhD. “We believe that the clinical data supports patient benefit through paracrine mechanisms, which differs from those attempting to transform cells into new heart cells, and believe that the approach has tremendous promise to help patients suffering from severe heart and respiratory diseases.”
Third Quarter 2020 Financial Results:
Net loss was $3.8 million for the third quarter of 2020, which is consistent with the $3.8 million net loss in the third quarter of 2019.
Research and development expenses were $2.5 million in the third quarter of 2020, compared to $2.0 million in the third quarter of 2019, primarily reflecting expenses incurred while conducting the Phase III pivotal CardiAMP Heart Failure Trial and pivotal CardiAMP Chronic Myocardial Ischemia Trial, and further developing the NK1R+ MSC program.
Selling, general and administrative expenses for the third quarter of 2020 totaled $1.4 million, which is consistent with the $1.4 million in the third quarter of 2019.
Net cash used in operations in the third quarter of 2020 was $3.6 million, compared to $1.5 million in the third quarter of 2019.
Anticipated Upcoming Milestones in Q4 2020:
BCDA-01: Pre-specified Data Safety Monitoring Board Review, including a futility analysis, of all patients enrolled in the CardiAMP Heart Failure Trial at the time of the analysis based on 60 patients that should have reached the primary one-year follow-up endpoint
BCDA-02: First patient treated in CardiAMP Chronic Myocardial Ischemia Trial
BCDA-03: FDA acceptance of Investigational New Drug application for CardiALLO NK1R+ MSC therapy, the Company’s allogenic therapeutic platform, for the treatment of ischemic heart failure
BCDA-04: FDA acceptance of Investigational New Drug application for NK1R+ MSC therapy 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 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 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, anticipated milestones, and other 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 our documents filed with the SEC, 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.
Michelle McAdam, Chronic Communications, Inc.
David McClung, Chief Financial Officer
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(1) September 30, 2020 and 2019 amounts are unaudited. December 31, 2019 amounts were derived from the audited Consolidated Financial Statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission on April 9, 2020.