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SAN CARLOS, Calif., May 20, 2019 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [OTC: 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 2019 and filed its quarterly report on Form 10-Q for the three months ended March 31, 2019 with the Securities and Exchange Commission on May 15, 2019.
2019 Business Highlights:
“It has been a productive start to 2019, with accelerating enrollment in the CardiAMP Heart Failure Trial, progress in the CardiALLO IND, and the recent FDA clearance of the AVANCE product family,” said BioCardia Chief Executive Officer Peter Altman, PhD. “Following a successful financing, we will be well-positioned to complete the first of our CardiAMP cell therapy pivotal trials, as planned.”
First Quarter 2019 Financial Results:
Anticipated Upcoming Milestones:
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, the Morph® steerable guide and sheath catheter portfolio including the new AVANCE™ steerable introducer family. 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 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 1, 2019, 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.
Michelle McAdam, Chronic Communications, Inc.
David McClung, Chief Financial Officer
Condensed Statements of Operations
(Unaudited In thousands, except share and per share amounts)
|Three Months ended March 31,|
|Net product revenue||$||76||$||82|
|Collaboration agreement revenue||140||117|
|Costs and expenses:|
|Cost of goods sold||106||157|
|Research and development||2,166||1,955|
|Selling, general and administrative||1,631||1,707|
|Total costs and expenses||3,903||3,819|
|Other income (expense):|
|Other expense, net||(1||)||—|
|Total other income (expense), net||22||36|
|Net loss per share, basic and diluted||$||(0.08||)||$||(0.09||)|
|Weighted-average shares used in computing net loss per share,|
|basic and diluted||43,628,958||38,236,056|
|Selected Balance Sheet Data|
|(amounts in thousands)|
|March 31,||December 31,|
|2019 (1)||2018 (1)|
|Cash, cash equivalents and short-term investments||$||2,838||$||5,358|
|Other current assets||690||860|
|Property, plant and equipment and other noncurrent assets||1,629||199|
|Liabilities and Stockholders’ Equity|
|Total stockholders’ equity||818||3,792|
|Total liabilities and stockholders’ equity||$||5,157||$||6,417|
|(1) March 31, 2019 amounts are unaudited. December 31, 2018 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, 2018, filed with the U.S. Securities and Exchange Commission on April 2, 2019.|
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