BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and
cell-derived therapeutics for the treatment of cardiovascular and
pulmonary diseases, today reported financial results for the year
ended December 31, 2023 and filed its annual report on Form 10-K
with the Securities and Exchange Commission. The Company will also
hold a conference call at 4:30 PM ET today in which it will discuss
business highlights with call details below.
“Heart failure of reduced ejection fraction or HFrEF remains an
unmet clinical need with none of the recently approved therapies
reducing mortality,” said BioCardia CEO Peter Altman, Ph.D. “The
interim data from our CardiAMP Heart Failure trial, where we missed
the primary endpoint, shows reduced heart death equivalents,
reduced major adverse cardiac events, reduced cardiac arrhythmias,
and enhanced heart function in treated patients relative to the
control patients. These results and their remarkable subgroup
outcomes in patients with active heart failure underlie the
potential to help millions of patients should they be confirmed.”
Dr. Altman continued, “In 2024, we aim to complete the study
follow-up, seek approval in Japan, and advance the confirmatory
CardiAMP Heart Failure II Trial. We also intend to advance our
earlier biotherapeutic product candidates, while securing
meaningful value from our supportive Helix™ Biotherapeutic Delivery
and Morph Access Innovations businesses.”
RECENT BUSINESS HIGHLIGHTS:
CardiAMP® Autologous Cell Therapy for Ischemic HFrEF
(BCDA-01)
The CardiAMP Cell Therapy Heart Failure Trial
- Study enrollment in the randomized double-blind controlled
trial, which has both FDA breakthrough designation and Medicare
coverage, was completed during the fourth quarter of 2023 as the
study was unlikely to be able to meet the primary endpoint as
designed.
- The interim results on 110 randomized patients were presented
at the Technology and Heart Failure Therapy meeting in March 2024
and showed treated patients appeared to benefit in the two most
important tiers of the primary composite endpoint. Treated patients
had a 37% relative risk reduction in heart death equivalent (all
cause death, heart transplantation, and left ventricular assist
device implantation) and a 9% reduction in non-fatal major adverse
cardiac and cerebrovascular events, but that both treated and
control patients improved in the third component of the primary
endpoint, of the six-minute walk distance.
- In a subgroup analysis of patients with elevated NTproBNP at
baseline – encompassing 59% of total enrolled randomized patients –
patients treated with CardiAMP cell therapy experienced an 86.2%
relative risk reduction in heart death equivalents and a 23.9%
relative risk reduction in MACCE. These patients saw more than a
17% lower rate of heart death equivalents at up to two years
compared to control patients treated with heart failure medication
alone (2.9% vs. 21.1%, respectively).
- The Company anticipates completing follow-up in the trial and
preparing this dataset on 115 randomized patients enrolled with a
minimum of one-year follow-up for final lock in the fourth quarter
of 2024. This data may be sufficient to support product approval in
Japan.
The CardiAMP Cell Therapy Heart Failure II Trial
- The study, approved by FDA in the fourth quarter of 2023, is a
confirmatory Phase III, multi-center, randomized, double-blinded,
sham-controlled study of up to 250 patients with NTproBNP levels
>500 pg/ml at up to 40 centers in the United States. The primary
endpoint is an outcomes composite score based on a three-tiered
Finkelstein-Schoenfeld hierarchical analysis. The tiers, starting
with the most serious events, would be (1) all-cause death,
including cardiac death equivalents such as heart transplant or
left ventricular assist device placement, ordered by time to event;
(2) non-fatal Major Adverse Coronary and Cerebrovascular Events
(MACCE), excluding those deemed procedure-related occurring within
the first seven days post-procedure (heart failure hospitalization,
stroke or myocardial infarction), ordered by time to event, and (3)
change from baseline in quality of life at a minimum of 12 months
and a maximum of 24 months.
- The trial has greater than 90 percent power (statistical
probability of success) to meet the primary endpoint based on the
CardiAMP Heart Failure Trial interim results.
- The Study was activated in the first quarter of 2024 and
subsequently received certification of Medicare reimbursement to
substantially offset the clinical costs of performing the
study.
CardiAMP Autologous Cell Therapy for Chronic Myocardial
Ischemia (BCDA-02)
- The CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial is
a Medicare reimbursed Phase III, multi-center, randomized,
double-blinded, controlled study of up to 343 patients at up to 40
clinical sites, designed to provide the primary support for the
safety and efficacy in pursuit of market clearance. The Company
intends to introduce an adaptive statistical analysis plan with an
initial assessment for efficacy when 100 patients reach their
primary endpoint, although aspects of this statistical analysis
plan remain the subject of study considerations with the FDA. Data
from the roll in cohort is expected in 2024.
CardiAMP Platform Opportunities
- BioCardia has had discussions on partnering its CardiAMP
therapy for other clinical indications and continues to explore
partnerships worldwide.
CardiALLO Allogeneic Mesenchymal Stem Cells for Ischemic
HFrEF (BCDA-03)
- The CardiALLO Phase I/II trial for the treatment of HFrEF
includes a 3+3 roll-in dose escalation cohort followed by a
60-patient randomized double-blind controlled study and utilizes
the Finkelstein Schoenfeld three tier primary composite endpoint of
mortality, MACCE, and functional capacity as measured by six-minute
walk distance. The cohort receiving the lowest dose of 20 million
cells was initiated in December 2023. There have been no
treatment-emergent adverse events, arrhythmias, rejection, or
allergic response, consistent with our presentation at the
Technology and Heart Failure Therapeutics meeting on March 4,
2024.
- The Company intends to fund later development through
nondilutive grant applications and partnering. With such funding,
it is possible to complete enrollment in Phase I as early as the
end of 2024. Phase II development is anticipated to be advanced in
both the United States and Japan and would also enroll in
approximately one year.
Helix Biotherapeutic Delivery Partnering
Business
- The Helix transendocardial biotherapeutic delivery system is a
therapeutic-enabling platform for minimally invasive targeted
delivery of biologic agents to the heart. Helix empowers a seamless
transition from bench to commercialization for partners. Our
biotherapeutic delivery partnerships are expected to enhance future
treatment options for millions of people suffering from heart
disease, offset the costs of biotherapeutic delivery for our own
programs, and provide our investors with meaningful revenue sharing
should our partnering efforts contribute successful therapeutic
development.
- In September 2023, our biotherapeutic delivery partner
CellProthera announced completion of enrollment in their Phase I/II
cell therapy study in post-myocardial infarction and that results
are expected soon.
- In March 2024, we announced a biotherapeutic delivery
partnership with StemCardia for a long-term partnership to advance
StemCardia’s investigational pluripotent stem cell product
candidate for the treatment of heart failure, initially through a
Phase I/II Clinical Study.
- Two additional premier biotherapeutic delivery partnerships are
expected in 2024.
Morph Access Innovations Business
- BioCardia expects to obtain FDA approval for a product family
of Morph DNA steerable sheath introducers in a variety of sizes and
lengths with clinical indications for use in the heart and
peripheral vasculature during the third quarter of 2024. These
Morph DNA products are derived from our FDA approved steerable
introducer platform utilized for navigating Helix within the heart
for biotherapeutic intervention. BioCardia is actively exploring
pathways for commercializing these products in the second half of
the year.
2023 FINANCIAL RESULTS:
- Revenues were $0.5 million in 2023, compared to $1.4 million in
2022, due primarily to the timing of revenue from new and existing
collaborative partners coupled with the fulfillment of performance
obligations for several partners in 2022.
- Research and development decreased to $7.7 million in 2023,
compared to $8.8 million in 2022, primarily due to the recent pause
of the CardiAMP Cell Therapy Heart Failure Trial and its subsequent
completion of enrollment coupled with reduced expenses in clinical
and related supporting functions.
- Selling, general and administrative expenses were $4.4 million
for the years ended 2023 and 2022.
- Our net loss was $11.6 million in 2023, compared to $11.9
million in 2022.
- Net cash used in operations was $10.0 million in 2023, compared
to $10.6 million in 2022. The Company ended the year with cash and
cash equivalents totaling $1.1 million, which together with
financing proceeds in the first quarter of 2024 provide runway into
the third quarter of 2024.
- The Company intends to remain listed on Nasdaq.
ANTICIPATED 2024 MILESTONES AND EVENTS:
- CardiAMP Cells Therapy for ischemic Heart Failure of Reduced
Ejection Fraction (BCDA-01)
- Q2: Enrollment in the CardiAMP Cell Therapy Heart Failure II
Pivotal Trial
- Q3: Japan’s Pharmaceutical and Medical Device Agency (PMDA)
consultation
- Q4: Final data from the CardiAMP Cell Therapy Heart Failure
Trial
- Q4: Submission of clinical data to Japan’s Pharmaceutical and
Medical Device Agency
- CardiAMP Cell Therapy for Chronic Myocardial Ischemia (BCDA-02)
- Q2: CardiAMP Chronic Myocardial Ischemia (CMI) Trial roll-in
cohort data
- Q3: Initiation of randomized cohort in pivotal CardiAMP CMI
Trial
- CardiALLO Allogeneic Mesenchymal Stem Cell Therapy for ischemic
HFrEF (BCDA-03)
- Q2: Completion of low-dose cohort.
- Q4: Completion of medium-dose cohort
- Helix Biotherapeutic Delivery Business
- Q2: Third revenue sharing partnership agreement
- Morph Access Innovations Business
- Q3: FDA approval of Morph DNA steerable introducer sheath
product family
Following management’s formal remarks, there will be a
question-and-answer session.
Participants can register for the conference by navigating to
https://dpregister.com/sreg/10187416/fbec8cfa30. Please note
that registered participants will receive their dial-in number upon
registration. For those who have not registered, to listen to
the call by phone, interested parties within the U.S. should call
1-833-316-0559 and international callers should call
1-412-317-5730. All callers should dial in approximately 10 minutes
prior to the scheduled start time and ask to be joined into the
BioCardia call. The conference call will also be available through
a live webcast, which can be accessed through the following
link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=Ya3BT5pb,
which is also available through the company’s website.
A webcast replay of the call will be available approximately one
hour after the end of the call through June 26, 2024, at the above
links. A telephonic replay of the call will be available through
April 10, 2024, and may be accessed by calling 1-877-344-7529
(domestic) or 1-412-317-0088 (international) and using access code
3499879.
ABOUT BIOCARDIA®BioCardia, Inc., headquartered
in Sunnyvale, California, is developing cellular and cell-derived
therapeutics for the treatment cardiovascular and pulmonary
disease. CardiAMP autologous and CardiALLO allogeneic cell
therapies are the Company’s biotherapeutic platforms for the
treatment of heart disease. BioCardia also works with partners to
provide its proprietary Helix transendocardial biotherapeutic
delivery system, as well as technology and services for the
development and commercialization of partners’ therapeutic agents.
The CardiAMP Cell Therapy Heart Failure Trial has been supported
financially by the Maryland Stem Cell Research Fund and the Center
for Medicare and Medicaid Services. For more information visit:
www.BioCardia.com.
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
and Japan’s Pharmaceutical and Medical Device Agency, FDA and
Japanese 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, the ability to enter into
licensing and partnering arrangements 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 March 27, 2024,
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: Miranda Peto, Marketing /
Investor RelationsEmail: mpeto@BioCardia.comPhone:
650-226-0120
Investor Contact: David McClung, Chief
Financial OfficerEmail: investors@BioCardia.comPhone:
650-226-0120
BioCardia, Inc.Consolidated Statements
of Operations (in thousands, except share and per
share amounts)
|
|
Year ended December 31, |
|
|
2023 |
|
2022 |
Revenue: |
|
|
Net product revenue |
$ |
— |
|
$ |
3 |
|
Collaboration agreement revenue |
|
477 |
|
|
1,349 |
|
Total revenue |
|
477 |
|
|
1,352 |
|
Costs and expenses: |
|
|
|
|
|
|
Research and development |
|
7,726 |
|
|
8,834 |
|
Selling, general and administrative |
|
4,395 |
|
|
4,419 |
|
Total costs and expenses |
|
12,121 |
|
|
13,253 |
|
Operating loss |
|
(11,644 |
) |
|
(11,901 |
) |
Other income (expense): |
|
|
|
|
|
|
Total other income (expense), net |
|
73 |
|
|
(6 |
) |
Net loss |
$ |
(11,571 |
) |
$ |
(11,907 |
) |
|
|
|
|
|
|
|
Net loss per share, basic and diluted |
$ |
(0.55 |
) |
$ |
(0.67 |
) |
|
|
|
|
|
|
|
Weighted-average shares used in computing |
|
|
|
|
|
|
net loss per share, basic and diluted |
|
21,179,974 |
|
|
17,720,972 |
|
|
|
|
|
|
|
|
BioCardia, Inc.Selected Balance Sheet
Data(amounts in thousands)
|
|
December 31, |
|
December 31, |
|
|
2023(1) |
|
2022(1) |
|
|
|
|
|
|
|
Assets: |
|
|
|
|
|
|
Cash and cash equivalents |
$ |
1,103 |
|
$ |
7,363 |
|
Other current assets |
|
358 |
|
|
501 |
|
Property, plant and equipment and other noncurrent assets |
|
1,526 |
|
|
1,929 |
|
Total assets |
$ |
2,987 |
|
$ |
9,793 |
|
Liabilities and Stockholders Equity (Deficit) |
|
|
|
|
|
|
Current liabilities |
$ |
3,608 |
|
$ |
3,585 |
|
Operating lease liability – noncurrent |
|
982 |
|
|
1,316 |
|
Total stockholders equity (deficit) |
|
(1,603 |
) |
|
4,892 |
|
Total liabilities and stockholders equity (deficit) |
$ |
2,987 |
|
$ |
9,793 |
|
|
|
|
|
|
|
|
(1) December 31, 2023 and 2022 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, 2023,
filed with the U.S. Securities and Exchange Commission on March 27,
2024. |
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