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Share Name | Share Symbol | Market | Type |
---|---|---|---|
BioCardia Inc | NASDAQ:BCDA | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.375 | 0.375 | 0.69 | 0.385 | 0.375 | 0.375 | 74,865 | 05:00:08 |
“Foremost on our minds, we want to recognize and thank our many outstanding clinical partners and their teams who are on the front lines of dealing with the COVID-19 situation nationwide,” said BioCardia CEO Peter Altman, PhD. “Their dedication to patient care, even at risk to their own health, is a testament to the commitment we have seen ourselves in their work on our clinical programs.”
Business Highlights:
“The last 15 months have been extremely productive around our CardiAMP Heart Failure Trial. We had significantly accelerated enrollment through the first quarter, achieved positive outcomes from our DSMB reviews, added evidence supporting our belief that the Helix is the leading myocardial biotherapeutic delivery system in the world, and received new U.S. and European Union patents around our novel diagnostic assay for patient selection,” said Dr. Altman. “We have also seen regulatory momentum in the U.S. and EU, with a new U.S. clearance and CE Mark extension, progress made towards initiating our CardiAMP Chronic Myocardial Ischemia Trial, and submission of our CardiALLO IND. Finally, we positioned the Company for growth by successfully uplisting the company to the Nasdaq Capital Market and closing new financing. We value our achievements in the last year and are focused on accelerating enrollment in the CardiAMP Phase III Trials this year.”
Full Year 2019 Financial Result:
Anticipated Upcoming Milestones:
BioCardia hosted a conference call/webcast, Tuesday, March 31 to provide updates on the CardiAMP Heart Failure Trial featuring national co-principal investigators, Amish Raval, MD, of the University of Wisconsin and Carl Pepine, MD, of the University of Florida, Gainesville. To access a recording of the webcast, please visit: www.biocardia.com/investors/events-presentations/id/1036. The replay of the webcast will be available for a limited time on the BioCardia website.
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, 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 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, 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 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.
Media Contact: Michelle McAdam, Chronic Communications, Inc.Email: michelle@chronic-comm.comPhone: 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 December 31, | Year ended December 31, | ||||||||||||||
2019 | 2018 | 2019 | 2018 | ||||||||||||
(Unaudited) | (Unaudited) | ||||||||||||||
Revenue: | |||||||||||||||
Net product revenue | $ | 43 | $ | 59 | $ | 182 | $ | 282 | |||||||
Collaboration agreement revenue | 172 | 44 | 528 | 343 | |||||||||||
Total revenue | 215 | 103 | 710 | 625 | |||||||||||
Costs and expenses: | |||||||||||||||
Cost of goods sold | 37 | 116 | 358 | 517 | |||||||||||
Research and development | 2,170 | 2,205 | 8,562 | 8,453 | |||||||||||
Selling, general and administrative | 1,543 | 1,442 | 6,003 | 5,757 | |||||||||||
Total costs and expenses | 3,750 | 3,763 | 14,923 | 14,727 | |||||||||||
Operating loss | (3,535 | ) | (3,660 | ) | (14,213 | ) | (14,102 | ) | |||||||
Other income (expense): | |||||||||||||||
Interest income | 34 | 18 | 87 | 118 | |||||||||||
Gain on change in fair value of redemptive feature embedded in convertible notes | — | — | 52 | — | |||||||||||
Interest expense | — | — | (112 | ) | — | ||||||||||
Loss on extinguishment of convertible notes | — | — | (521 | ) | — | ||||||||||
Other expense | — | — | (2 | ) | (3 | ) | |||||||||
Total other income (expense) | 34 | 18 | (496 | ) | 115 | ||||||||||
Net loss | $ | (3,501 | ) | $ | (3,642 | ) | $ | (14,709 | ) | $ | (13,987 | ) | |||
Net loss per share, basic and diluted | $ | (0.51 | ) | $ | (0.85 | ) | $ | (2.61 | ) | $ | (3.28 | ) | |||
Weighted-average shares used in computing net loss per share, basic and diluted | 6,825,183 | 4,304,631 | 5,644,328 | 4,264,178 | |||||||||||
BIOCARDIA, INC. | |||||||
Selected Balance Sheet Data | |||||||
(amounts in thousands) | |||||||
December 31, | December 31, | ||||||
2019 | 2018 | ||||||
Assets: | |||||||
Cash, cash equivalents and short-term investments | $ | 5,585 | $ | 5,358 | |||
Other current assets | 793 | 860 | |||||
Property, plant and equipment and other noncurrent assets | 1,300 | 199 | |||||
Total assets | $ | 7,678 | $ | 6,417 | |||
Liabilities and Stockholders’ Equity | |||||||
Current liabilities | $ | 4,003 | $ | 2,548 | |||
Noncurrent liabilities | 1,305 | 77 | |||||
Total stockholders’ (deficit) equity | 2,370 | 3,792 | |||||
Total liabilities and stockholders’ equity | $ | 7,678 | $ | 6,417 | |||
1 Year BioCardia Chart |
1 Month BioCardia Chart |
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