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 for the fourth quarter and full year ended December 31, 2018, filed its annual 10-K with the Securities and Exchange Commission, and shared recent business highlights.
Recent Business Highlights:
- Enrollment in the Phase III pivotal CardiAMP™ Heart Failure Trial expanded to three additional active sites – Michigan Cardiovascular Institute, Northwestern University, and Texas Heart Institute – increasing the total number of participating sites to 21 world class centers in the United States. Thirty-two patients have been treated to date with no treatment emergent major adverse cardiac events reported.
- Twelve-month results for the initial 10-patient roll-in cohort for the CardiAMP™ Heart Failure Trial were presented at the American Heart Association Scientific Sessions in November 2018. At one year, eight of the 10 patients experienced clinically meaningful improvement in exercise capacity, seven patients enjoyed clinically meaningful improvement in quality of life, statistically significant improvement in a measure of heart function (wall motion score) was seen, and all patients were alive and out of the hospital.
- In the fourth quarter of 2018, BioCardia engineering teams completed FDA submission for the AVANCE™ steerable introducer, indicated for introducing various cardiovascular catheters into the heart, including via the left side of the heart through the interatrial septum. AVANCE™ has the potential to be FDA-cleared before the end of the second quarter of 2019. This product leverages new “DNA” technology developed for the Company’s Morph® family of steerable introducers and applies it for transseptal procedures, such as atrial fibrillation ablation, left atrial appendage closure and percutaneous mitral valve repair, a market which is expected to grow substantially over the next decade. This technology is expected to further enhance delivery of the CardiAMP™ and CardiALLO™ cell therapies.
- BioCardia’s biologics group filed an Investigational New Drug (IND) application with the FDA for the CardiALLO™ Cell Therapy System, an investigational allogenic culture-expanded “off the shelf” mesenchymal cell therapy for the treatment of ischemic heart failure. This therapy involves NK1R+ mesenchymal stem cells, which are believed to be activated by Substance P, a chemical that has been shown to facilitate healing and minimize damage in the body. This therapy is intended for the treatment of patients that do not qualify for CardiAMP™ cell therapy due to low bone marrow cell potency, as determined by the proprietary CardiAMP™ assay.
- BioCardia expanded its partnership with CellProThera to a clinical trial in Singapore which will evaluate Cell ProThera’s therapy delivered by BioCardia’s Helix™ Biotherapeutic Delivery System for the treatment of patients following a heart attack. The agreement offers the potential for BioCardia to receive double-digit royalty payments on future sales of the combination product.
- The Company closed on $4 million in new financing, with the intent that it will bridge the company through filing for submission of the CardiALLO™ IND and FDA clearance of AVANCE™, and contribute to enhanced enrollment in the CardiAMP™ Heart Failure Trial.
“The BioCardia team delivered another solid quarter, including publishing and presenting preliminary results from the ongoing CardiAMP pivotal trial. That these preliminary results were better for patients in almost all clinical readouts than those from our Phase II clinical experience is exciting, and supports our thesis that CardiAMP cell therapy has the potential to be the first heart failure therapy in the last two decades that is actually curative and doesn’t simply slow disease progression,” said BioCardia CEO Peter Altman. “I am very proud of BioCardia’s accomplishments in 2018 and excited about the synergistic potential of our CardiAMP, CardiALLO, Helix and Morph portfolio. In the year ahead, we will be focused on accelerating patient enrollment and completing the CardiAMP Heart Failure Trial.”
Full Year 2018 Financial Results:
- Revenues increased 30 percent year over year to $625,000 in 2018 compared to $479,000 in 2017.
- Research and development expenses increased to $8.5 million in 2018, compared to $5.8 million in 2017, primarily due to expenses associated with the pivotal CardiAMP™ Heart Failure Trial.
- Selling, general and administrative expenses decreased to $5.8 million in 2018, compared to $6.4 million in 2017.
- Net loss was $14.0 million for 2018, compared to $12.3 million for 2017, primarily due to the increases in research and development expenses noted above.
- Net cash used in operations in 2018 was $11.1 million, as compared to $8.7 million in 2017.
Anticipated Upcoming Milestones:
- Q2 2019: FDA clearance of AVANCE™ steerable sheath
- Q2 2019: FDA acceptance of the CardiALLO™ IND application
- Q3 2019: Second pre-specified Data and Safety Monitoring Board (DSMB) readout of Phase III Pivotal CardiAMP™ Heart Failure Trial
- Q3 2020: Third pre-specified DSMB readout of Phase III Pivotal CardiAMP™ Heart Failure Trial
- Q3 2020: Completion of enrollment in the CardiAMP™ Heart Failure Trial. While this projected date is later than anticipated, the number of patient consents is accelerating in 2019 and the company expects this trend to continue. This positive outlook is based on several factors: stem cell trials competing for the same patient population are now completed, several experienced sites from those trials have been added into the CardiAMP Heart Failure Trial, and awareness of the trial is increasing based on the presentation of one-year results from the roll-in cohort last fall.
- Once the CardiAMP Heart Failure Trial reaches the later stages of enrollment, the company is prepared to activate a second pivotal trial of CardiAMP cell therapy in chronic myocardial ischemia, having previously received IDE approval and Medicare reimbursement for the 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 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 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 April 2, 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.
|Condensed Balance Sheet Data|
|(amounts in thousands)|
|December 31,||December 31,|
|2018 (1)||2017 (1)|
|Cash and cash equivalents||$||5,358||$||12,689|
|Other current assets||860||626|
|Property, plant and equipment and other noncurrent assets||199||223|
|Liabilities and Stockholders’ Equity|
|Total stockholders’ equity||3,792||11,125|
|Total liabilities and stockholders’ equity||$||6,417||$||13,538|
(1) December 31, 2018 and 2017 amounts were derived from the audited Consolidated Financial Statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2018, filed with the U.S. Securities and Exchange Commission on April 2, 2019.
|Condensed Statements of Operations|
|(amounts in thousands, except share and per share amounts)|
|Year ended December 31,|
|Net product revenue||$||282||$||389|
|Collaboration agreement revenue||343||90|
|Costs and expenses:|
|Cost of goods sold||517||690|
|Research and development||8,453||5,799|
|Selling, general and administrative||5,757||6,395|
|Total costs and expenses||14,727||12,884|
|Other income (expense):|
|Other income (expense), net||(3||)||2|
|Total other income, net||115||97|
|Net loss per share, basic and diluted||$||(0.36||)||$||(0.32||)|
|Weighted-average shares used in computing|
|net loss per share, basic and diluted||38,377,606||38,160,543|