SAN CARLOS, Calif., May 13, 2021 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a leader in the development of comprehensive solutions for cardiovascular and pulmonary cell based therapies, today reported financial results for the first quarter of 2021 and filed its quarterly report on Form 10-Q for the three months ended March 31, 2021 with the Securities and Exchange Commission on May 13, 2021.
“We continue to make progress across our autologous and allogeneic cell therapy platforms and pipeline, targeting cardiovascular and pulmonary disease,” said Peter Altman, Ph.D., BioCardia’s Chief Executive Officer and President. “Our team is focused on accelerating clinical enrollment and expansion of our CardiAMP autologous cell therapy in both the heart failure (BCDA-01) and chronic myocardial ischemia (BCDA-02) indications with clinical partners in the U.S., Canada, and Japan. We are also working towards the acceptance of INDs for our allogeneic cell therapy product candidates for cardiac (BCDA-03) and pulmonary disease (BCDA-04) indications.”
Q1 and Recent Business Highlights:
Anticipated Upcoming Milestones:
About BioCardia®
BioCardia, Inc., headquartered in San Carlos, California, is developing regenerative biologic therapies to treat cardiovascular and pulmonary disease. CardiAMP™ autologous and NK1R+ allogeneic cell therapies are the Company’s biotherapeutic product candidates in clinical development. The Company’s current products include the Helix™ transendocardial delivery system, the Morph® steerable guide and sheath catheter portfolio and the AVANCE™ steerable introducer family. BioCardia also partners with other biotherapeutic companies to provide its Helix systems and development 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, preliminary conclusions about new data, the achievement of any of the anticipated upcoming milestones, our positioning for growth or the market for 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 March 30, 2021, under the caption titled “Risk Factors.” BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
Media Contact:
Michelle McAdam, Chronic Communications, Inc.
Email: michelle@chronic-comm.com
Phone: 310-902-1274
Investor Contact:
David McClung, Chief Financial Officer
Email: investors@BioCardia.com
Phone: 650-226-0120
BioCardia, Inc. | ||||||||||
Condensed Statements of Operations | ||||||||||
(In thousands, except share and per share amounts) | ||||||||||
Three Months ended March 31, |
||||||||||
2021 | 2020 | |||||||||
Revenue: | ||||||||||
Net product revenue | $ | — | $ | 5 | ||||||
Collaboration agreement revenue | 46 | 33 | ||||||||
Total revenue | 46 | 38 | ||||||||
Costs and expenses: | ||||||||||
Cost of goods sold | — | 4 | ||||||||
Research and development | 1,841 | 2,786 | ||||||||
Selling, general and administrative | 1,177 | 1,857 | ||||||||
Total costs and expenses | 3,018 | 4,647 | ||||||||
Operating loss | (2,972) | (4,609) | ||||||||
Other income (expense): | ||||||||||
Interest income | 4 | 16 | ||||||||
Other expense | (1) | (1) | ||||||||
Total other income (expense) | 3 | 15 | ||||||||
Net loss | $ | (2,969) | $ | (4,594) | ||||||
Net loss per share, basic and diluted | $ | (0.18) | $ | (0.67) | ||||||
Weighted-average shares used in computing | ||||||||||
net loss per share, basic and diluted | 16,569,268 | 6,831,976 |
BioCardia, Inc. | ||||||
Selected Balance Sheet Data | ||||||
(amounts in thousands) | ||||||
March 31, | December 31, | |||||
2021 (1) | 2020 (1) | |||||
Assets: | ||||||
Cash and cash equivalents | $ | 21,502 | $ | 21,407 | ||
Other current assets | 1,157 | 1,251 | ||||
Property, plant and equipment and other noncurrent assets | 649 | 766 | ||||
Total assets | $ | 23,308 | $ | 23,424 | ||
Liabilities and Stockholders’ Equity | ||||||
Current liabilities | $ | 4,746 | $ | 4,248 | ||
Total stockholders’ equity | 18,562 | 19,176 | ||||
Total liabilities and stockholders’ equity | $ | 23,308 | $ | 23,424 | ||
(1) March 31, 2021 amounts are unaudited. December 31, 2020 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, 2020, filed with the U.S. Securities and Exchange Commission on March 30, 2021. |
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