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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 | |
---|---|---|---|---|---|---|---|---|---|---|
0.0191 | 5.03% | 0.399 | 0.3806 | 0.399 | 0.40 | 0.378 | 0.391 | 110,576 | 20:39:32 |
Update on Ongoing CardiAMP™ Autologous Cell Therapy Pivotal Heart Failure Trial:
Second Quarter 2019 Business Highlight:
Significant Events After Close of Second Quarter 2019:
“Achieving FDA clearance for our AVANCE device will allow us to access the fast-growing transseptal market with an enabling technology designed to improve therapeutic delivery,” said BioCardia CEO Peter Altman, PhD. “The financing and uplist to Nasdaq after completion of the quarter should enable us to build upon the enrollment momentum we are seeing in our CardiAMP HF Trial to further advance this important new therapeutic option for patients suffering from ischemic heart failure.”
Second Quarter 2019 Financial Results:
Anticipated Upcoming Milestones:
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 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-Q filed with the Securities and Exchange Commission on August 9, 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.
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 | |||||||||||||||
(Unaudited In thousands, except share and per share amounts) | |||||||||||||||
Three Months ended June 30, | Six Months ended June 30, | ||||||||||||||
2019 | 2018 | 2019 | 2018 | ||||||||||||
Revenue: | |||||||||||||||
Net product revenue | $ | 62 | $ | 89 | $ | 139 | $ | 171 | |||||||
Collaboration agreement revenue | 24 | 150 | 163 | 267 | |||||||||||
Total revenue | 86 | 239 | 302 | 438 | |||||||||||
Costs and expenses: | |||||||||||||||
Cost of goods sold | 191 | 135 | 297 | 292 | |||||||||||
Research and development | 2,219 | 2,031 | 4,385 | 3,986 | |||||||||||
Selling, general and administrative | 1,438 | 1,325 | 3,070 | 3,032 | |||||||||||
Total costs and expenses | 3,848 | 3,491 | 7,752 | 7,310 | |||||||||||
Operating loss | (3,762 | ) | (3,252 | ) | (7,450 | ) | (6,872 | ) | |||||||
Other income (expense): | |||||||||||||||
Interest income | 13 | 35 | 36 | 71 | |||||||||||
Other expense, net | (1 | ) | — | (1 | ) | — | |||||||||
Total other income (expense), net | 12 | 35 | 35 | 71 | |||||||||||
Net loss | $ | (3,750 | ) | $ | (3,217 | ) | $ | (7,415 | ) | $ | (6,801 | ) | |||
Net loss per share, basic and diluted | $ | (0.77 | ) | $ | (0.76 | ) | $ | (1.53 | ) | $ | (1.60 | ) | |||
Weighted-average shares used in computing net loss per share, basic and diluted | 4,847,829 | 4,249,698 | 4,847,746 | 4,249,192 |
BIOCARDIA, INC. | |||||||||||
Selected Balance Sheet Data | |||||||||||
(amounts in thousands) | |||||||||||
June 30, | December 31, | ||||||||||
2019 (1) | 2018 (1) | ||||||||||
Assets: | |||||||||||
Cash, cash equivalents and short-term investments | $ | 517 | $ | 5,358 | |||||||
Other current assets | 635 | 860 | |||||||||
Property, plant and equipment and other noncurrent assets | 1,564 | 199 | |||||||||
Total assets | $ | 2,716 | $ | 6,417 | |||||||
Liabilities and Stockholders’ Equity | |||||||||||
Current liabilities | $ | 4,066 | $ | 2,548 | |||||||
Noncurrent liabilities | 886 | 77 | |||||||||
Total stockholders’ (deficit) equity | (2,236 | ) | 3,792 | ||||||||
Total liabilities and stockholders’ equity | $ | 2,716 | $ | 6,417 | |||||||
(1) June 30, 2019 and 2018 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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