BioCardia Reports 2019 Second Quarter Financial Results and Business Highlights
August 21 2019 - 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 second quarter 2019 and filed its quarterly report on Form
10-Q for the three and six months ended June 30, 2019 with the
Securities and Exchange Commission on August 14, 2019.
Update on Ongoing CardiAMP™ Autologous Cell Therapy
Pivotal Heart Failure Trial:
- The Phase III pivotal CardiAMP™ Heart Failure Trial of our lead
therapeutic candidate – 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 heart
failure that develops after a heart attack and chronic myocardial
ischemia – added two new centers to the trial and has accelerated
enrollment in the last quarter, with 23 world class U.S. centers
participating and 49 patients enrolled to date.
Second Quarter 2019 Business Highlight:
- The Company received 510(k) clearance from the FDA for the
BioCardia 8.5F AVANCE™ steerable introducer, indicated for
introducing various cardiovascular catheters into the heart,
including via the left side of the heart through the interatrial
septum. Commercial sale of this new product is anticipated to begin
in third quarter 2019.
Significant Events After Close of Second Quarter
2019:
- After the close of the second quarter, the Company completed a
$10 million financing, with a simultaneous listing on the Nasdaq
Capital Market.
“Achieving FDA clearance for our AVANCE device will allow us to
access the fast-growing transseptal market with an enabling
technology designed to improve therapeutic delivery,” said
BioCardia CEO Peter Altman, PhD. “The financing and uplist to
Nasdaq after completion of the quarter should enable us to build
upon the enrollment momentum we are seeing in our CardiAMP HF Trial
to further advance this important new therapeutic option for
patients suffering from ischemic heart failure.”
Second Quarter 2019 Financial Results:
- Net loss was $3.8 million for the second quarter of 2019,
compared to a $3.2 million net loss for the second quarter of
2018.
- Research and development expenses were $2.2 million in the
second quarter of 2019 compared to $2.0 million in the second
quarter of 2018, primarily due to expenses incurred while
conducting the pivotal CardiAMP™ Heart Failure Trial.
- Selling, general and administrative expenses for the second
quarter of 2019 totaled $1.4 million compared to $1.3 million in
the second quarter of 2018, primarily due to expenses associated
with the reverse stock split and the uplisting to the Nasdaq
exchange.
- Net cash used in operations in the second quarter of 2019 was
$2.3 million, a decrease of $0.5 million from $2.8 million in the
second quarter of 2018.
Anticipated Upcoming Milestones:
- Q3 2019: Data and Safety Monitoring Board (DSMB) readout of
Phase III CardiAMP™ Heart Failure Trial.
- Q3 2019: First commercial sale of AVANCE™ steerable
introducer.
- Q4 2019: FDA acceptance of the CardiALLO™ IND application.
- Q3 2020: Completion of enrollment in the CardiAMP™ Heart
Failure Trial.
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 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.
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 |
(Unaudited In thousands, except share and per share
amounts) |
|
|
|
|
|
Three Months ended June 30, |
|
Six Months ended June 30, |
|
|
|
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
Revenue: |
|
|
|
|
|
Net product
revenue |
$ |
62 |
|
$ |
89 |
|
$ |
139 |
|
$ |
171 |
|
|
Collaboration
agreement revenue |
|
24 |
|
|
150 |
|
|
163 |
|
|
267 |
|
|
|
Total revenue |
|
86 |
|
|
239 |
|
|
302 |
|
|
438 |
|
Costs and
expenses: |
|
|
|
|
|
|
|
|
|
Cost of goods
sold |
|
191 |
|
|
135 |
|
|
297 |
|
|
292 |
|
|
Research and
development |
|
2,219 |
|
|
2,031 |
|
|
4,385 |
|
|
3,986 |
|
|
Selling, general
and administrative |
|
1,438 |
|
|
1,325 |
|
|
3,070 |
|
|
3,032 |
|
|
|
Total costs and
expenses |
|
3,848 |
|
|
3,491 |
|
|
7,752 |
|
|
7,310 |
|
|
|
Operating
loss |
|
(3,762 |
) |
|
(3,252 |
) |
|
(7,450 |
) |
|
(6,872 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
|
|
Interest
income |
|
13 |
|
|
35 |
|
|
36 |
|
|
71 |
|
|
Other expense,
net |
|
(1 |
) |
|
— |
|
|
(1 |
) |
|
— |
|
|
|
Total other income
(expense), net |
|
12 |
|
|
35 |
|
|
35 |
|
|
71 |
|
Net loss |
|
$ |
(3,750 |
) |
$ |
(3,217 |
) |
$ |
(7,415 |
) |
$ |
(6,801 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share, basic and diluted |
$ |
(0.77 |
) |
$ |
(0.76 |
) |
$ |
(1.53 |
) |
$ |
(1.60 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
shares used in computing net loss per share, basic and diluted |
|
4,847,829 |
|
|
4,249,698 |
|
|
4,847,746 |
|
|
4,249,192 |
|
BIOCARDIA, INC. |
Selected
Balance Sheet Data |
(amounts
in thousands) |
|
|
June 30, |
|
|
December 31, |
|
2019 (1) |
|
|
2018 (1) |
|
|
|
|
|
|
Assets: |
|
|
|
|
|
Cash, cash equivalents and short-term investments |
$ |
517 |
|
|
$ |
5,358 |
Other current assets |
|
635 |
|
|
|
860 |
Property, plant
and equipment and other noncurrent assets |
1,564 |
|
|
|
199 |
Total assets |
$ |
2,716 |
|
|
$ |
6,417 |
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
Current liabilities |
$ |
4,066 |
|
|
$ |
2,548 |
Noncurrent liabilities |
|
886 |
|
|
|
77 |
Total stockholders’ (deficit)
equity |
|
(2,236 |
) |
|
|
3,792 |
Total liabilities and
stockholders’ equity |
$ |
2,716 |
|
|
$ |
6,417 |
|
|
|
|
|
|
(1) June 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. |
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