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:
- Positive DSMB recommendation for CardiAMP Heart Failure Trial – The independent Data Safety Monitoring Board completed its prespecified data review for the Phase III pivotal CardiAMP Heart Failure Trial and issued a positive recommendation to continue the trial, as planned. They indicated there were no safety concerns associated with its review of safety follow-up results on 35 patients and all additional data available on all 50 patients enrolled in the trial as of August 31, 2019.
- New European patent for CardiAMP diagnostic assay – The European Patent Office issued the company a new patent for “Methods of Measuring Potential for Therapeutic Potency and Defining Dosages for Autologous Cell Therapies.” This patent addresses the problem of patient cell variability and high manufacturing costs associated with typical autologous cell therapy by identifying a specific biomarker signature in a patient’s bone marrow that is utilized in the CardiAMP pre-procedural diagnostic assay. The test enables physicians to determine if a patient is a good candidate for CardiAMP cell therapy prior to treatment, enabling point-of-care therapy processing and eliminating costly remote cell selection and processing.
- Commercial availability of AVANCE™ Bi-Directional Steerable Introducer Sheath – The company initiated the commercial release of its AVANCE Bi-Directional Steerable Introducer Sheath for introducing various cardiovascular catheters into the heart, including transseptal procedures. The device addresses shortcomings associated with currently available introducers by providing uniform bending in all directions that is intended to reduce “whip,” including a smooth tip-to dilator transition to promote ease of entry into the left atrium, and increasing steerability to improve access to hard-to-reach sites.
- Extension of AstraZeneca relationship – The company signed an extension to its existing agreement with AstraZeneca for its Helix™ biotherapeutic delivery system catheter, shown to present the lowest risk to patients for cell and gene delivery to the heart, which included a $1 million upfront payment. The agreement is exclusive with respect to a class of biotherapeutic agents that the company is not currently developing on its own or with any other party.
- Uplisting to NASDAQ – BioCardia’s stock was successfully uplisted to the NASDAQ exchange on August 2, 2019.
- $10 million financing – The company closed a $10 million public offering in August.
- CE Mark Renewal – The Company successfully renewed its CE Mark for the Helix Biotherapeutic Delivery Catheter and Morph® Universal Deflectable Guide Catheter, both used in the delivery of biotherapeutics to the heart. CE Mark renewal enables BioCardia to continue supporting partners conducting biotherapeutic clinical trials outside of the U.S., such as CellProthera and Centro Cardiologico Monzino, as well as commercial sales in the European Union and other countries that recognize CE Mark through May 2024.
Third Quarter 2019 Financial Results:
- Revenue was $194,000, an increase of $110,000 from the third quarter of 2018.
- Net loss was $3.8 million for the third quarter of 2019, compared to a $3.5 million net loss for the third quarter of 2018.
- Research and development expenses were $2.0 million in the third quarter of 2019 compared to $2.3 million in the third quarter of 2018.
- Selling, general and administrative expenses for the third quarter of 2019 totaled $1.4 million compared to $1.3 million in the third quarter of 2018.
- Net cash used in operations in the third quarter of 2019 was $1.5 million, a decrease of $0.5 million from $2.0 million in the third quarter of 2018.
“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:
- Q4 2019: FDA Clearance of Morph DNA Catheter System
- Q2 2020: FDA acceptance of the CardiALLO™ Neurokinin-1 Receptor Positive Mesenchymal Stem Cell IND application
- Q4 2020: Data Safety Monitoring Board Review of all patients enrolled in the CardiAMP Heart Failure Trial, including 60 patients at primary one-year follow-up endpoint
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.
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 |
|Nine Months ended |
|Net product revenue||$||1||$||52||$||139||$||223|
|Collaboration agreement revenue||193||32||356||299|
|Costs and expenses:|
|Cost of goods sold||24||109||321||401|
|Research and development||2,007||2,262||6,392||6,248|
|Selling, general and administrative||1,390||1,283||4,460||4,315|
|Total costs and expenses||3,421||3,654||11,173||10,964|
|Other income (expense):|
|Gain on change in fair value of redemptive feature embedded in convertible notes||52||—||52||—|
|Loss on extinguishment of convertible notes||(521||)||—||(521||)||—|
|Total other income (expense)||(565||)||26||(530||)||97|
|Net loss per share, basic and diluted||$||(0.63||)||$||(0.83||)||$||(2.13||)||$||(2.43||)|
|Weighted-average shares used in computing net loss per share, basic and diluted||6,030,662||4,253,100||5,263,058||4,250,509|
|Selected Balance Sheet Data|
|(amounts in thousands)|
|September 30,||December 31,|
|2019 (1)||2018 (1)|
|Cash, cash equivalents and short-term investments||$||8,910||$||5,358|
|Other current assets||327||860|
|Property, plant and equipment and other noncurrent assets||1,444||199|
|Liabilities and Stockholders’ Equity|
|Total stockholders’ (deficit) equity||5,194||3,792|
|Total liabilities and stockholders’ equity||$||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.|