BIOCARDIA REPORTS 2019 FINANCIAL RESULTS AND RECENT BUSINESS HIGHLIGHTS
April 09 2020 - 1:03PM
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.
- 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.
- 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.comPhone: 310-902-1274
Investor Contact: David McClung, Chief
Financial Officer Email: investors@BioCardia.com Phone:
650-226-0120
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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 |
|
|
|
|
|
|
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