SAN CARLOS, Calif.--(BUSINESS WIRE)--
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 third quarter 2018 and filed its quarterly report on Form 10-Q for the three and nine months ended September 30, 2018 with the Securities and Exchange Commission.
Third Quarter 2018 Business Highlights:
- Enrollment in the pivotal CardiAMP™ Heart Failure Trial has expanded to 18 world class centers in the United States, as detailed on ClinicalTrials.Gov.
- Preliminary six-month results for the initial 10-patient roll-in cohort for the CardiAMP Heart Failure Trial were published in a Viewpoint article in Circulation Research in September, showing encouraging outcomes in exercise capacity, symptom relief and quality of life. There was statistically significant patient improvement in Six Minute Walk Distance (+47.8m ± 19.6, 20.5% relative improvement; p=0.01), improvement in New York Heart Association Heart Failure Class (40% of patients improving one class, p=0.037), and a positive trend in Minnesota Living with Heart Failure Questionnaire (MLHFQ) Score (-10.2 ± 7.9, 31% relative improvement, p=0.21), when compared to their baseline values.
- Nine-month data for these 10 patients was presented at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in September, showing clinically meaningful improvement in symptoms, quality of life and exercise capacity. The results did not present as statistically significant when compared to their baseline values, due in part to the lack of nine-month follow-up on one patient who experienced an adverse event. Missing values due to clinical events are assigned a score worse than any observed value to capture the event for comparison to the control arm. Average improvements in exercise capacity and quality of life were greater in magnitude than those observed in the previous Phase II randomized placebo-controlled trial of the CardiAMP Cell Therapy System, which reached statistical significance in both endpoints when compared to control.
- The Company expanded its current collaboration with CellProThera to the SingXpand Clinical Trial in Singapore. The study will evaluate the safety and efficacy of CellProThera’s in vitro expanded peripheral blood CD34+ stem cells delivered using BioCardia’s Helix™ Biotherapeutic Delivery System for the treatment of patients soon after a heart attack.
Third Quarter 2018 Financial Results:
- Revenues decreased to $84,000 for the third quarter of 2018 compared to $130,000 for the third quarter of 2017.
- Research and development expenses increased to $2.3 million in the third quarter of 2018, compared to $1.7 million in the third 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 $1.28 million in the third quarter of 2018, compared to $1.32 million in the third quarter of 2017.
- Net loss was $3.5 million for the third quarter of 2018, compared to $3.0 million for the third quarter of 2017, primarily due to the increases in research and development expenses noted above.
- Net cash used in operations in the third quarter of 2018 was $2.0 million, as compared to $1.8 million in the third quarter of 2017.
Anticipated Upcoming Milestones:
- 12-month results from the CardiAMP Heart Failure Trial 10-patient roll-in cohort have been accepted for presentation at the American Heart Association Scientific Sessions meeting in Chicago on November 12.
- Filing of the Investigational New Drug (IND) application 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 fourth quarter of 2018.
- FDA submission for the new AVANCE™ steerable introducer, indicated for introducing various cardiovascular catheters into the heart, including via the left side of the heart through the interatrial septum, in the fourth quarter of 2018. This AVANCE product family has potential to be cleared for market release by the FDA before the end of the second quarter of 2019.
- FDA submission for the new Morph® “DNA” steerable guide, indicated for introducing various cardiovascular catheters into the heart, in the first quarter of 2019. The Morph product is also expected to further enhance delivery of our CardiAMP and CardiALLO cell therapies. This Morph product has potential to be cleared for market release by the FDA before the end of the second quarter of 2019.
- Dosing of the first patient in the pivotal CardiAMP Chronic Myocardial Ischemia Trial in the first quarter of 2019.
- Completion of enrollment in the pivotal CardiAMP Heart Failure Trial in the third quarter of 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, 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-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.
|Condensed Statements of Operations|
|(Unaudited In thousands, except share and per share amounts)|
| Three Months ended |
| Nine Months ended |
|Net product revenue||$||52||$||88||$||223||$||298|
|Collaboration agreement revenue||32||42||299||81|
|Costs and expenses:|
|Cost of goods sold||109||147||401||525|
|Research and development||2,262||1,700||6,248||4,028|
|Selling, general and administrative||1,283||1,322||4,315||4,708|
|Total costs and expenses||3,654||3,169||10,964||9,261|
|Other income (expense):|
|Other expense, net||(3||)||3||(3||)||2|
|Total other income (expense), net||26||38||97||60|
|Net loss per share, basic and diluted||$||(0.09||)||$||(0.08||)||$||(0.27||)||$||(0.23||)|
|Weighted-average shares used in computing net loss per share, basic and diluted||38,277,908||38,146,751||38,254,583||38,141,654|
|Selected Balance Sheet Data|
|(amounts in thousands)|
|September 30,||December 31,|
|Cash, cash equivalents and short-term investments||$||4,820||$||12,689|
|Other current assets||528||626|
|Property, plant and equipment and other noncurrent assets||208||223|
|Liabilities and Stockholders’ Equity|
|Total stockholders’ equity||2,944||11,125|
|Total liabilities and stockholders’ equity||$||5,556||$||13,538|
|(1) September 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.|