SAN CARLOS, Calif., May 20, 2019 (GLOBE NEWSWIRE) -- 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 first quarter of 2019 and filed its quarterly report on Form 10-Q for the three months ended March 31, 2019 with the Securities and Exchange Commission on May 15, 2019.
2019 Business Highlights:
- Our lead therapeutic candidate is 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 two clinical indications: heart failure that develops after a heart attack, and chronic myocardial ischemia. The Phase III pivotal CardiAMP™ Heart Failure Trial is currently enrolling at 21 world class centers in the United States, with 37 patients enrolled to date. The Phase III pivotal CardiAMP™ Chronic Myocardial Ischemia Trial has been designed to leverage our experience in the heart failure trial and efficiently utilize the same clinical infrastructure. The Department of Health and Human Services Centers for Medicare & Medicaid Services has designated that both CardiAMP™ cell therapy trials qualify for Medicare national coverage.
- Our biologics group filed an Investigational New Drug (IND) application with the FDA for our second therapeutic candidate, 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. We are working to obtain FDA acceptance of the IND for a Phase I/II trial for CardiALLO™ Cell Therapy System for the treatment of ischemic heart failure in the second quarter of 2019.
- Our Helix™ biotherapeutic delivery system, which enables both the CardiAMP™ and CardiALLO™ cell therapies, is also being used in three clinical trials of other cell therapies outside of the United States and in a number of pre-clinical biotherapeutic programs. These programs have generated modest partnering revenue to date.
- The Company received 510(k) clearance from the FDA 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. 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 procedures, 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.
“It has been a productive start to 2019, with accelerating enrollment in the CardiAMP Heart Failure Trial, progress in the CardiALLO IND, and the recent FDA clearance of the AVANCE product family,” said BioCardia Chief Executive Officer Peter Altman, PhD. “Following a successful financing, we will be well-positioned to complete the first of our CardiAMP cell therapy pivotal trials, as planned.”
First Quarter 2019 Financial Results:
- Net loss was $3.7 million for the first quarter of 2019, which is comparable to the $3.6 million net loss for the first quarter of 2018.
- Research and development expenses were $2.2 million in the first quarter of 2019 compared to $2.0 million in the first quarter of 2018, primarily due to expenses incurred while conducting the pivotal CardiAMP™ Heart Failure Trial.
- Selling, general and administrative expenses for the first quarter of 2019 totaled $1.6 million, a 4.5 percent decrease compared to $1.7 million in the first quarter of 2018.
- Net cash used in operations in the first quarter of 2019 was $2.5 million, a decrease of $571,000 from $3.0 million in the first quarter of 2018.
Anticipated Upcoming Milestones:
- Q2 2019: FDA acceptance of the CardiALLO™ IND application
- Q3 2019: Data and Safety Monitoring Board (DSMB) readout of Phase III CardiAMP™ Heart Failure Trial
- Q3 2020: DSMB readout, including futility analysis, of Phase III CardiAMP™ Heart Failure Trial
- 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 including 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-K filed with the Securities and Exchange Commission on April 1, 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 March 31,|
|Net product revenue||$||76||$||82|
|Collaboration agreement revenue||140||117|
|Costs and expenses:|
|Cost of goods sold||106||157|
|Research and development||2,166||1,955|
|Selling, general and administrative||1,631||1,707|
|Total costs and expenses||3,903||3,819|
|Other income (expense):|
|Other expense, net||(1||)||—|
|Total other income (expense), net||22||36|
|Net loss per share, basic and diluted||$||(0.08||)||$||(0.09||)|
|Weighted-average shares used in computing net loss per share,|
|basic and diluted||43,628,958||38,236,056|
|Selected Balance Sheet Data|
|(amounts in thousands)|
|March 31,||December 31,|
|2019 (1)||2018 (1)|
|Cash, cash equivalents and short-term investments||$||2,838||$||5,358|
|Other current assets||690||860|
|Property, plant and equipment and other noncurrent assets||1,629||199|
|Liabilities and Stockholders’ Equity|
|Total stockholders’ equity||818||3,792|
|Total liabilities and stockholders’ equity||$||5,157||$||6,417|
|(1) March 31, 2019 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.|