BioCardia Reports First Quarter 2020 Financial Results and Business Highlights
May 15 2020 - 8:00AM
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 first quarter of 2020 and filed its quarterly report on
Form 10-Q for the three months ended March 31, 2020 with the
Securities and Exchange Commission on May 15, 2020.
First Quarter 2020 Business Highlights:
- CardiAMP® Heart Failure Trial received
positive review by Data Safety Monitoring Board - In March
2020, the independent DSMB completed a prespecified review and
issued a positive recommendation to continue the Company’s Phase
III pivotal CardiAMP Heart Failure Trial as planned, since they
found no safety concerns. To date, 74 patients have been enrolled
in the study at 25 world class centers throughout the U.S.
- FDA clearance received for guide catheter used in cell
therapy delivery - The Company received FDA
clearance for the Morph® DNA Deflectable Guide
Catheter in January 2020. The Morph DNA
is designed to enhance the procedural control of the Helix™
Biotherapeutic Delivery System during CardiAMP cell therapy
delivery in the heart. The device is designed to be virtually
whipless around curves, offer bidirectional deflection within the
heart, and further enhance both control and ease of use for
physicians.
- Three new patents granted in U.S. and Asia –
Also in January 2020, the Company was issued three new patents. An
additional U.S. patent now protects its proprietary cell potency
assay used to identify candidates for CardiAMP cell therapy, in
addition to an existing European patent. Japan and China both
issued new patents covering the Company’s biotherapeutic delivery
approaches using radial artery access for trans-endocardial
delivery of cardiac cell therapy.
“We have started the year off well by achieving key regulatory
and clinical milestones and adding to our already-strong
intellectual property portfolio,” said BioCardia Chief Executive
Officer Peter Altman, PhD. “While CardiAMP Heart Failure Trial
cases have been paused as clinical sites care for COVID-19
patients, sites continue to screen candidates and there are
patients scheduled for treatment in the second quarter as centers
resume elective procedures.”
First Quarter 2020 Financial Results:
- Net loss was $4.6 million for the first quarter of 2020
compared to $3.7 million in the first quarter of 2019.
- Research and development expenses were $2.8 million in the
first quarter of 2020 compared to $2.2 million in the first quarter
of 2019, primarily due to expenses incurred while conducting the
pivotal CardiAMP Heart Failure Trial, development of the CardiALLO™
Cell Therapy System and our other therapeutic programs.
- Selling, general and administrative expenses for the first
quarter of 2020 totaled $1.9 million, compared to $1.6 million in
the first quarter of 2019, primarily due to increased stock
compensation expenses, including a repricing of stock options in
January 2020.
- Net cash used in operations in the first quarter of 2020 was
$3.0 million compared to $2.5 million in the first quarter of
2019.
Anticipated Upcoming Milestones:
- Q2 2020: Phase III pivotal trial commencement and first sites
activated in CardiAMP Chronic Myocardial Ischemia (CMI) Trial
(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, for
the treatment of ischemic heart failure.
- Q4 2020: Pre-specified Data Safety Monitoring Board Review of
all patients enrolled, including futility analysis, based on sixty
(60) patients that will have reached the primary one-year follow-up
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 CMI Trial
(BCDA-02)
- Q4 2020: FDA acceptance of Investigational New Drug application
for Neurokinin-1 Receptor Positive Mesenchymal Stem Cell Therapy
(BDCA-04) for the treatment of Acute Respiratory Distress Syndrome
as a result of COVID-19
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 approved products include
the Helix transendocardial delivery system and its steerable guide
and sheath catheter portfolio. BioCardia also partners with other
biotherapeutic companies to provide its Helix System 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 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. michelle@chronic-comm.com(310) 902-1274
Investor Contact: David McClung, Chief
Financial Officer Investors@BioCardia.com(650) 226-0120
BIOCARDIA, INC.Condensed Statements of
Operations (Unaudited In thousands, except share
and per share amounts)
|
|
|
|
|
Three Months ended March 31, |
|
|
|
|
|
2020 |
|
|
2019 |
|
Revenue: |
|
|
|
|
|
Net product
revenue |
$ |
5 |
|
$ |
76 |
|
|
Collaboration
agreement revenue |
|
33 |
|
|
140 |
|
|
|
Total revenue |
|
38 |
|
|
216 |
|
Costs and
expenses: |
|
|
|
|
|
Cost of goods
sold |
|
4 |
|
|
106 |
|
|
Research and
development |
|
2,786 |
|
|
2,166 |
|
|
Selling, general and
administrative |
|
1,857 |
|
|
1,631 |
|
|
|
Total costs and
expenses |
|
4,647 |
|
|
3,903 |
|
|
|
Operating loss |
|
(4,609 |
) |
|
(3,687 |
) |
Other income
(expense): |
|
|
|
|
|
Interest income |
|
16 |
|
|
23 |
|
|
Other expense,
net |
|
(1 |
) |
|
(1 |
) |
|
|
Total other income
(expense), net |
|
15 |
|
|
22 |
|
Net loss |
|
$ |
(4,594 |
) |
$ |
(3,655 |
) |
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted |
$ |
(0.67 |
) |
$ |
(0.86 |
) |
|
|
|
|
|
|
|
|
Weighted-average
shares used in computing net loss per share, |
|
|
|
basic and
diluted |
|
6,831,976 |
|
|
4,284,450 |
|
|
|
|
|
|
|
|
|
BIOCARDIA, INC. |
|
|
|
|
|
Selected Balance Sheet
Data |
|
|
|
|
|
(amounts in
thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
2020 (1) |
|
|
2019 (1) |
|
|
|
|
|
|
Assets: |
|
|
|
|
|
Cash, cash equivalents and short-term investments |
$ |
2,587 |
|
|
$ |
5,585 |
Other current assets |
|
632 |
|
|
|
793 |
Property, plant
and equipment and other noncurrent assets |
1,165 |
|
|
|
1,300 |
Total assets |
$ |
4,384 |
|
|
$ |
7,678 |
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
Current liabilities |
$ |
4,510 |
|
|
$ |
4,003 |
Noncurrent liabilities |
|
1,157 |
|
|
|
1,305 |
Total stockholders’
equity |
|
(1,283 |
) |
|
|
2,370 |
Total liabilities and
stockholders’ equity |
$ |
4,384 |
|
|
$ |
7,678 |
|
|
|
|
|
|
(1) March 31,
2020 amounts are unaudited. December 31, 2019 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 9, 2020. |
|
|
BioCardia (NASDAQ:BCDAW)
Historical Stock Chart
From Jun 2024 to Jul 2024
BioCardia (NASDAQ:BCDAW)
Historical Stock Chart
From Jul 2023 to Jul 2024