BioCardia, Inc. Reports Second Quarter 2018 Financial Results and Business Highlights
SAN CARLOS, Calif., Aug. 9, 2018 /PRNewswire/ -- 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 second quarter 2018 and filed its quarterly report on Form 10-Q for the three and six months ended June 30, 2018 with the Securities and Exchange Commission.
Second Quarter 2018 Financial Results:
- Revenues increased to $239,000 for the second quarter of 2018 compared to $112,000 for the second quarter of 2017.
- Net loss was $3.2 million for the second quarter of 2018, compared to $2.9 million for the second quarter of 2017.
- Research and development expenses increased to $2.0 million in the second quarter of 2018, compared to $1.3 million in the second quarter of 2017, primarily due to expenses associated with the pivotal CardiAMP™ Heart Failure Trial and development of the Company's second cell therapy candidate, the CardiALLO™ Cell Therapy System.
- Selling, general and administrative expenses decreased to $1.3 million in the second quarter of 2018, compared to $1.6 million in the second quarter of 2017, primarily due to lower stock compensation expense.
- Net cash used in operations in the second quarter of 2018 was $2.8 million, as compared to $2.1 million in the second quarter of 2017.
2018 Corporate Highlights:
- Enrollment in the pivotal CardiAMP Heart Failure Trial has expanded to 17 world class centers in the United States as detailed on ClinicalTrials.Gov.
- Two abstracts have been accepted for presentation at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Diego, one of the world's largest and most important educational meeting specializing in interventional cardiovascular medicine. Both presentations are scheduled for September 24, 2018:
- "The CardiAMP Heart Failure Study: First Results from Unblinded Roll-In Phase", to be presented at 9:06 am PDT.
- "Performance of Helix Transendocardial Biotherapeutic Delivery System after 300 Cases", to be presented at 9:18 am PDT.
- The U.S. Food and Drug Administration approved a second pivotal Investigational Device Exemption trial for the CardiAMP Cell Therapy System for the treatment of chronic myocardial ischemia with refractory angina, the "CardiAMP Chronic Myocardial Ischemia Trial". The Centers for Medicare and Medicaid Services (CMS) has approved this trial for national reimbursement coverage.
- The Company received a new US patent related to its CardiAMP cell potency assay, providing further protection to its autologous cell therapy programs in both heart failure and chronic myocardial ischemia indications.
Anticipated Upcoming Milestones:
- 12-month data from the CardiAMP Heart Failure Trial 10-patient roll-in cohort in the fourth quarter 2018.
- Filing of the Investigational New Drug (IND) for the CardiALLO Cell Therapy System, an investigational allogenic culture expanded "off the shelf" mesenchymal cell therapy for the treatment of ischemic heart failure, in the fourth quarter 2018.
- Filing for FDA approval of an advanced bidirectional steerable guide system in the fourth quarter 2018.
- Dosing of the first patient in the pivotal CardiAMP Chronic Myocardial Ischemia Trial in the first quarter 2019.
- Completion of enrollment in the pivotal CardiAMP Heart Failure Trial in the third quarter 2019.
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 and the Morph® steerable guide and sheath catheter portfolio. 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 dosing of patients in our clinical trials, the availability of data from our clinical trials, filings with the FDA, 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 March 16, 2018, 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.
David McClung, Chief Financial Officer
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, --------------------------- ------------------------- 2018 2017 2018 2017 ---- ---- ---- ---- Revenue: Net product revenue $89 $101 $171 $210 Collaboration agreement revenue 150 11 267 39 Total revenue 239 112 438 249 --- --- --- --- Costs and expenses: Cost of goods sold 135 203 292 378 Research and development 2,031 1,295 3,986 2,328 Selling, general and administrative 1,325 1,582 3,032 3,386 Total costs and expenses 3,491 3,080 7,310 6,092 ----- ----- ----- ----- Operating loss (3,252) (2,968) (6,872) (5,843) ------ ------ ------ ------ Other income (expense): Interest income 35 23 71 23 Other expense, net - - - (1) Total other income (expense), net 35 23 71 22 --- --- --- --- Net loss $(3,217) $(2,945) $(6,801) $(5,821) ======= ======= ======= ======= Net loss per share, basic and diluted $(0.08) $(0.08) $(0.18) $(0.15) Weighted-average shares used in computing net loss per share, basic and diluted 38,247,288 38,140,232 38,242,728 38,139,063
BIOCARDIA, INC. Selected Balance Sheet Data (amounts in thousands) June 30, December 31, -------- ------------ 2018 (1) 2017 (1) ------- ------- Assets: Cash, cash equivalents and short-term investments $6,834 $12,689 Other current assets 609 626 Property, plant and equipment and other noncurrent assets 218 223 Total assets $7,661 $13,538 Liabilities and Stockholders' Equity Current liabilities $1,819 $2,332 Noncurrent liabilities 84 81 Total stockholders' equity 5,758 11,125 Total liabilities and stockholders' equity $7,661 $13,538 (1) June 30, 2018 amounts are unaudited. December 31, 2017 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, 2017, filed with the U.S. Securities and Exchange Commission on March 16, 2018.
SOURCE BioCardia, Inc.
Company Codes: OTC-PINK:BCDA, OTC-QB:BCDA