SAN CARLOS, Calif., Aug. 21, 2019 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today reported financial results and business highlights for the second quarter 2019 and filed its quarterly report on Form 10-Q for the three and six months ended June 30, 2019 with the Securities and Exchange Commission on August 14, 2019.
Update on Ongoing CardiAMP™ Autologous Cell Therapy Pivotal Heart Failure Trial:
- The Phase III pivotal CardiAMP™ Heart Failure Trial of our lead therapeutic candidate – the investigational CardiAMP™ Cell Therapy System, which provides an autologous bone marrow-derived cell therapy (using a patient’s own cells) for the treatment of heart failure that develops after a heart attack and chronic myocardial ischemia – added two new centers to the trial and has accelerated enrollment in the last quarter, with 23 world class U.S. centers participating and 49 patients enrolled to date.
Second Quarter 2019 Business Highlight:
- The Company received 510(k) clearance from the FDA for the BioCardia 8.5F AVANCE™ steerable introducer, indicated for introducing various cardiovascular catheters into the heart, including via the left side of the heart through the interatrial septum. Commercial sale of this new product is anticipated to begin in third quarter 2019.
Significant Events After Close of Second Quarter 2019:
- After the close of the second quarter, the Company completed a $10 million financing, with a simultaneous listing on the Nasdaq Capital Market.
“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:
- Net loss was $3.8 million for the second quarter of 2019, compared to a $3.2 million net loss for the second quarter of 2018.
- Research and development expenses were $2.2 million in the second quarter of 2019 compared to $2.0 million in the second quarter of 2018, primarily due to expenses incurred while conducting the pivotal CardiAMP™ Heart Failure Trial.
- Selling, general and administrative expenses for the second quarter of 2019 totaled $1.4 million compared to $1.3 million in the second quarter of 2018, primarily due to expenses associated with the reverse stock split and the uplisting to the Nasdaq exchange.
- Net cash used in operations in the second quarter of 2019 was $2.3 million, a decrease of $0.5 million from $2.8 million in the second quarter of 2018.
Anticipated Upcoming Milestones:
- Q3 2019: Data and Safety Monitoring Board (DSMB) readout of Phase III CardiAMP™ Heart Failure Trial.
- Q3 2019: First commercial sale of AVANCE™ steerable introducer.
- Q4 2019: FDA acceptance of the CardiALLO™ IND application.
- Q3 2020: Completion of enrollment in the CardiAMP™ Heart Failure Trial.
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.
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 |
|Six Months ended |
|Net product revenue||$||62||$||89||$||139||$||171|
|Collaboration agreement revenue||24||150||163||267|
|Costs and expenses:|
|Cost of goods sold||191||135||297||292|
|Research and development||2,219||2,031||4,385||3,986|
|Selling, general and administrative||1,438||1,325||3,070||3,032|
|Total costs and expenses||3,848||3,491||7,752||7,310|
|Other income (expense):|
|Other expense, net||(1||)||—||(1||)||—|
|Total other income (expense), net||12||35||35||71|
|Net loss per share, basic and diluted||$||(0.77||)||$||(0.76||)||$||(1.53||)||$||(1.60||)|
|Weighted-average shares used in computing net loss per share, basic and diluted||4,847,829||4,249,698||4,847,746||4,249,192|
|Selected Balance Sheet Data|
|(amounts in thousands)|
|June 30,||December 31,|
|2019 (1)||2018 (1)|
|Cash, cash equivalents and short-term investments||$||517||$||5,358|
|Other current assets||635||860|
|Property, plant and equipment and other noncurrent assets||1,564||199|
|Liabilities and Stockholders’ Equity|
|Total stockholders’ (deficit) equity||(2,236||)||3,792|
|Total liabilities and stockholders’ equity||$||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.|