SAN CARLOS, Calif., Nov. 19, 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 third quarter 2019 and filed its quarterly report on Form 10-Q for the three and nine months ended September 30, 2019 with the Securities and Exchange Commission.
Update on Ongoing CardiAMP™ Autologous Cell Therapy Pivotal Heart Failure Trial:
The company recently received FDA approval for an IDE supplement for the Phase III pivotal CardiAMP Heart Failure Trial of its lead therapeutic candidate. This will enable patients in the control group to cross over to CardiAMP treatment once their follow-up for the CardiAMP Trial has been completed. The IDE supplement also enables BioCardia to cover all out-of-pocket insurance co-pays for patients with Medicare coverage, so their participation in the trial will now be free. These two areas were previously barriers to participation for patients, who were eager to receive the therapy and less interested in being in the control arm, and were also responsible for their own co-pays. The company expects these changes, coupled with site-specific action plans, to further accelerate trial enrollment, which currently stands at 58 patients enrolled to date at 24 world class U.S. centers.
Third Quarter 2019 Business Highlights:
Third Quarter 2019 Financial Results:
“Achievements around our investigational CardiAMP cell therapy were the highlights of the last quarter, with a positive DSMB review, FDA approval of our IDE supplement, and a new European patent recognizing the innovation inherent in our pre-treatment assay designed to optimize patient outcomes and lower costs,” said BioCardia CEO Peter Altman, PhD. “At the same time, we made great progress with our other innovations: the first commercial use of the new AVANCE steerable introducer sheath in September, which can leverage the growing market for transseptal procedures, and extension of our AstraZeneca relationship, which enables our Helix delivery system to be used with new therapies being developed outside of the company.”
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 September 30, | Nine Months ended September 30, | ||||||||||||||
2019 | 2018 | 2019 | 2018 | ||||||||||||
Revenue: | |||||||||||||||
Net product revenue | $ | 1 | $ | 52 | $ | 139 | $ | 223 | |||||||
Collaboration agreement revenue | 193 | 32 | 356 | 299 | |||||||||||
Total revenue | 194 | 84 | 495 | 522 | |||||||||||
Costs and expenses: | |||||||||||||||
Cost of goods sold | 24 | 109 | 321 | 401 | |||||||||||
Research and development | 2,007 | 2,262 | 6,392 | 6,248 | |||||||||||
Selling, general and administrative | 1,390 | 1,283 | 4,460 | 4,315 | |||||||||||
Total costs and expenses | 3,421 | 3,654 | 11,173 | 10,964 | |||||||||||
Operating loss | (3,227 | ) | (3,570 | ) | (10,678 | ) | (10,442 | ) | |||||||
Other income (expense): | |||||||||||||||
Interest income | 17 | 29 | 53 | 100 | |||||||||||
Gain on change in fair value of redemptive feature embedded in convertible notes | 52 | — | 52 | — | |||||||||||
Interest expense | (112 | ) | — | (112 | ) | — | |||||||||
Loss on extinguishment of convertible notes | (521 | ) | — | (521 | ) | — | |||||||||
Other expense | (1 | ) | (3 | ) | (2 | ) | (3 | ) | |||||||
Total other income (expense) | (565 | ) | 26 | (530 | ) | 97 | |||||||||
Net loss | $ | (3,792 | ) | $ | (3,544 | ) | $ | (11,208 | ) | $ | (10,345 | ) | |||
Net loss per share, basic and diluted | $ | (0.63 | ) | $ | (0.83 | ) | $ | (2.13 | ) | $ | (2.43 | ) | |||
Weighted-average shares used in computing net loss per share, basic and diluted | 6,030,662 | 4,253,100 | 5,263,058 | 4,250,509 | |||||||||||
BIOCARDIA, INC. | |||||||
Selected Balance Sheet Data | |||||||
(amounts in thousands) | |||||||
September 30, | December 31, | ||||||
2019 (1) | 2018 (1) | ||||||
Assets: | |||||||
Cash, cash equivalents and short-term investments | $ | 8,910 | $ | 5,358 | |||
Other current assets | 327 | 860 | |||||
Property, plant and equipment and other noncurrent assets | 1,444 | 199 | |||||
Total assets | $ | 10,681 | $ | 6,417 | |||
Liabilities and Stockholders’ Equity | |||||||
Current liabilities | $ | 4,044 | $ | 2,548 | |||
Noncurrent liabilities | 1,443 | 77 | |||||
Total stockholders’ (deficit) equity | 5,194 | 3,792 | |||||
Total liabilities and stockholders’ equity | $ | 10,681 | $ | 6,417 | |||
(1) September 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. | |||||||