SAN CARLOS, Calif., April 09, 2020 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: 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, 2019 and recent business highlights, and filed its annual 10-K with the Securities and Exchange Commission.
“Foremost on our minds, we want to recognize and thank our many outstanding clinical partners and their teams who are on the front lines of dealing with the COVID-19 situation nationwide,” said BioCardia CEO Peter Altman, PhD. “Their dedication to patient care, even at risk to their own health, is a testament to the commitment we have seen ourselves in their work on our clinical programs.”
Business Highlights:
- CardiAMP® Cell Therapy
- CardiAMP Heart Failure Trial (BCDA-01) received positive DSMB recommendations – the independent Data Safety Monitoring Board completed two prespecified data reviews since 2019 for the Phase III pivotal trial of its lead autologous cell therapy for the treatment of heart failure and issued positive recommendations in both instances to continue the trial, as planned, as there were no safety concerns. The most recent review took place in March 2020 after 74 patients were enrolled.
- CardiAMP Heart Failure Trial enrollment was increasing into March 2020 and is now paused due to COVID-19. Six new centers joined the trial in 2019: Ascension St. Mary’s Hospital in Michigan, California Pacific Medical Center in San Francisco, Keck Hospital of the University of Southern California in Los Angeles, Northwestern University in Chicago, NYU Langone Health in New York, and Texas Heart Institute in Houston. This totals 24 centers activated in the trial by the end of 2019.
- New patents granted covering CardiAMP diagnostic assay for patient selection – both the U.S. Patent Office and the European Patent Office each issued the company a new patent for “Methods of Measuring Potential for Therapeutic Potency and Defining Dosages for Autologous Cell Therapies.” These patents address 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.
- CardiAMP Chronic Myocardial Ischemia Trial (BCDA-02) began site activation efforts – the Company is working to initiate the second pivotal trial for CardiAMP cell therapy in the indication of chronic myocardial ischemia. The trial will build on, and benefit from, the experience and infrastructure from the CardiAMP Heart Failure program.
- CardiALLO™ Cell Therapy
- IND submission filed with FDA for CardiALLO Cell Therapy Trial (BCDA-03) targeting patients excluded from CardiAMP HF Trial – the initial submission was filed in the second quarter of 2019 and the Company is currently addressing FDA comments.
- IND submission filed with FDA for CardiALLO Cell Therapy Trial (BCDA-03) targeting patients excluded from CardiAMP HF Trial – the initial submission was filed in the second quarter of 2019 and the Company is currently addressing FDA comments.
- Helix™ Biotherapeutic Delivery System
- Positive data presented on patients treated with Helix early after a heart attack – in a presentation at EuroPCR in May, new data suggested that patients receiving therapy using the Helix delivery catheter experienced improvements in left ventricular function and symptoms on top of successful percutaneous coronary intervention and optimal standard care after acute myocardial infarction.
- AstraZeneca partnership extended – the Company signed an extension to its existing pre-clinical agreement with AstraZeneca for its Helix delivery catheter, 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.
- Company continued additional pre-clinical and academic research partnerships – the Company is continuing its clinical work with CellProThera in Singapore and Europe using Helix to deliver CellProThera’s CD-34 cells for acute infarction in a clinical trial setting, and is actively engaged with four major U.S. academic institutions to use Helix in pre-clinical programs.
- CE Mark renewed – the Company successfully renewed its CE Mark for the Helix delivery catheter and Morph® Universal Deflectable Guide Catheter through May 2024, both used in the delivery of biotherapeutics to the heart.
- Advanced steerable introducers and guide products
- FDA clearance and commercial availability achieved for 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 for transseptal procedures.
- FDA clearance and commercial availability achieved for 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 for transseptal procedures.
- Financial
- Uplisting to Nasdaq – BioCardia’s stock was successfully uplisted to the Nasdaq Capital Market on August 2, 2019.
- $10 million financing – the company closed a $10 million public equity offering in August 2019.
“The last 15 months have been extremely productive around our CardiAMP Heart Failure Trial. We had significantly accelerated enrollment through the first quarter, achieved positive outcomes from our DSMB reviews, added evidence supporting our belief that the Helix is the leading myocardial biotherapeutic delivery system in the world, and received new U.S. and European Union patents around our novel diagnostic assay for patient selection,” said Dr. Altman. “We have also seen regulatory momentum in the U.S. and EU, with a new U.S. clearance and CE Mark extension, progress made towards initiating our CardiAMP Chronic Myocardial Ischemia Trial, and submission of our CardiALLO IND. Finally, we positioned the Company for growth by successfully uplisting the company to the Nasdaq Capital Market and closing new financing. We value our achievements in the last year and are focused on accelerating enrollment in the CardiAMP Phase III Trials this year.”
Full Year 2019 Financial Result:
- Revenues increased 14 percent year over year to $710,000 in 2019 compared to $625,000 in 2018.
- Research and development expenses increased to $8.6 million in 2019, compared to $8.5 million in 2018, primarily due to expenses associated with the pivotal CardiAMP™ Heart Failure Trial.
- Selling, general and administrative expenses increased to $6.0 million in 2019, compared to $5.8 million in 2018.
- Net loss was $14.7 million for 2019, compared to $14.0 million for 2018.
- Net cash used in operations in 2019 was $9.4 million, as compared to $11.1 million in 2018.
Anticipated Upcoming Milestones:
- Q2 2020: Phase III pivotal trial commencement/first sites activated in CardiAMP Chronic Myocardial Ischemia (CMI) Trial, the second Phase III pivotal trial of CardiAMP (BCDA-02)
- Q2 2020: FDA acceptance of Investigational New Drug application for CardiALLO Neurokinin-1 Receptor Positive Mesenchymal Stem Cell Therapy (BCDA-03), the company’s second therapeutic platform
- Q4 2020: Pre-specified Data Safety Monitoring Board Review of all patients enrolled in the CardiAMP Heart Failure Trial, including futility analysis, based on the 60 patients that will have reached the primary one-year endpoint at the time of analysis (BCDA-01)
- Q4 2020: Pre-specified Data Safety Monitoring Board Review of safety data from roll-in cohort in CardiAMP Chronic Myocardial Ischemia (CMI) Trial (BCDA-02)
BioCardia hosted a conference call/webcast, Tuesday, March 31 to provide updates on the CardiAMP Heart Failure Trial featuring national co-principal investigators, Amish Raval, MD, of the University of Wisconsin and Carl Pepine, MD, of the University of Florida, Gainesville. To access a recording of the webcast, please visit: www.biocardia.com/investors/events-presentations/id/1036. The replay of the webcast will be available for a limited time on the BioCardia website.
About BioCardia®
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 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, preliminary conclusions about new data, the achievement of any of the anticipated upcoming milestones, our positioning for growth or the market for 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 9, 2020, under the caption titled “Risk Factors.” BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
Media Contact:
Michelle McAdam, Chronic Communications, Inc.
Email: michelle@chronic-comm.com
Phone: 310-902-1274
Investor Contact:
David McClung, Chief Financial Officer
Email: investors@BioCardia.com
Phone: 650-226-0120
| BIOCARDIA, INC. | |||||||||||||||
| Condensed Statements of Operations | |||||||||||||||
| (In thousands, except share and per share amounts) | |||||||||||||||
| Three Months ended December 31, | Year ended December 31, | ||||||||||||||
| 2019 | 2018 | 2019 | 2018 | ||||||||||||
| (Unaudited) | (Unaudited) | ||||||||||||||
| Revenue: | |||||||||||||||
| Net product revenue | $ | 43 | $ | 59 | $ | 182 | $ | 282 | |||||||
| Collaboration agreement revenue | 172 | 44 | 528 | 343 | |||||||||||
| Total revenue | 215 | 103 | 710 | 625 | |||||||||||
| Costs and expenses: | |||||||||||||||
| Cost of goods sold | 37 | 116 | 358 | 517 | |||||||||||
| Research and development | 2,170 | 2,205 | 8,562 | 8,453 | |||||||||||
| Selling, general and administrative | 1,543 | 1,442 | 6,003 | 5,757 | |||||||||||
| Total costs and expenses | 3,750 | 3,763 | 14,923 | 14,727 | |||||||||||
| Operating loss | (3,535 | ) | (3,660 | ) | (14,213 | ) | (14,102 | ) | |||||||
| Other income (expense): | |||||||||||||||
| Interest income | 34 | 18 | 87 | 118 | |||||||||||
| Gain on change in fair value of redemptive feature embedded in convertible notes | — | — | 52 | — | |||||||||||
| Interest expense | — | — | (112 | ) | — | ||||||||||
| Loss on extinguishment of convertible notes | — | — | (521 | ) | — | ||||||||||
| Other expense | — | — | (2 | ) | (3 | ) | |||||||||
| Total other income (expense) | 34 | 18 | (496 | ) | 115 | ||||||||||
| Net loss | $ | (3,501 | ) | $ | (3,642 | ) | $ | (14,709 | ) | $ | (13,987 | ) | |||
| Net loss per share, basic and diluted | $ | (0.51 | ) | $ | (0.85 | ) | $ | (2.61 | ) | $ | (3.28 | ) | |||
| Weighted-average shares used in computing net loss per share, basic and diluted | 6,825,183 | 4,304,631 | 5,644,328 | 4,264,178 | |||||||||||
| BIOCARDIA, INC. | |||||||
| Selected Balance Sheet Data | |||||||
| (amounts in thousands) | |||||||
| December 31, | December 31, | ||||||
| 2019 | 2018 | ||||||
| Assets: | |||||||
| Cash, cash equivalents and short-term investments | $ | 5,585 | $ | 5,358 | |||
| Other current assets | 793 | 860 | |||||
| Property, plant and equipment and other noncurrent assets | 1,300 | 199 | |||||
| Total assets | $ | 7,678 | $ | 6,417 | |||
| Liabilities and Stockholders’ Equity | |||||||
| Current liabilities | $ | 4,003 | $ | 2,548 | |||
| Noncurrent liabilities | 1,305 | 77 | |||||
| Total stockholders’ (deficit) equity | 2,370 | 3,792 | |||||
| Total liabilities and stockholders’ equity | $ | 7,678 | $ | 6,417 | |||