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 first
quarter of 2024 and filed its quarterly report on Form 10-Q for the
three months ended March 31, 2024 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. Following
management’s formal remarks, there will be a question-and-answer
session.
First Quarter 2024 Highlights
- CardiAMP™ autologous cell therapy
for patients with ischemic heart failure observation of 86%
relative risk reduction in mortality in those with elevated
NTproBNP presented at THT2024;
- Confirmatory pivotal trial activated
with CMS reimbursement intended to confirm these results;
- CardiAMP autologous cell therapy for
patients with refractory angina showed improved exercise tolerance
and reduced chest pain in open label roll-in cohort;
- CardiALLO™ allogenic cell therapy
for patients with ischemic heart failure low dose cohort first
results presented at THT2024;
- StemCardia biotherapeutic delivery
partnership established for Phase I/II development;
- CellProthera biotherapeutic delivery
partner Phase I/II results accepted for presentation; and
- Operational cash burn of $1.5M.
“In 2024 we have had positive clinical results from all three of
our autologous and allogeneic cell therapy product candidates for
important cardiovascular indications,” said BioCardia CEO Peter
Altman, Ph.D. “Our CardiAMP autologous cell therapy program in
ischemic heart failure has shown a remarkable relative risk
reduction in mortality for patients with active heart failure where
established therapies have had minimal impact. Significant goals
for 2024 include submitting this therapy for approval in Japan,
advancing our two lead pivotal trials in the United States which
are reimbursed by Medicare and major commercial insurance plans,
and supporting our biotherapeutics delivery partnerships.”
RECENT BUSINESS HIGHLIGHTS:
CardiAMP Autologous Cell Therapy for Patients with
Ischemic Heart Failure (BCDA-01)
The CardiAMP Heart Failure Trial is an ongoing randomized,
double-blinded, controlled clinical trial in the United States with
125 patients enrolled, including a 10-patient roll-in cohort. The
interim results from this study, with 110 of the 115 randomized
patients, were presented at the Technology and Heart Failure
Therapeutics (THT) meeting on March 4, 2024. Over a mean 20 months
of follow-up, patients with advanced chronic heart failure who
received a single endomyocardial dose of autologous CardiAMP cell
therapy had a 37% relative risk reduction in all-cause heart death
equivalents and a 9% relative risk reduction in non-fatal incidence
of heart attacks, strokes and hospitalization due to heart failure
(MACCE). The subgroup analysis of patients with elevated NTproBNP
at baseline – encompassing 59% of total enrolled randomized
patients - demonstrated an 86% relative risk reduction in heart
death equivalents and 24% relative risk reduction in MACCE as well
as improvement in six-minute walk distance and improvement in
quality of life. Final results are expected to be available in Q4
2024.
The CardiAMP Cell Therapy Heart Failure II Trial, as approved by
the FDA, is intended to confirm these results. The study is a Phase
III, multi-center, randomized, double blinded, sham-controlled
study designed to include up to 250 patients with NTproBNP levels
>500 pg/ml enrolled at up to 40 centers in the United States.
The trial has greater than 90 percent power (statistical
probability of success) to meet the primary endpoint based on the
CardiAMP HF Trial interim results. This study was activated in the
first quarter of 2024 with a goal of completing enrollment two
years after the first patient is enrolled.
CardiAMP Autologous Cell Therapy for Patients with
Chronic Myocardial Ischemia (BCDA-02)
The CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial is a
Phase III, multi-center, randomized, double-blinded, controlled
study of up to 343 patients at up to forty clinical sites. Results
from the recently completed open label roll-in cohort of patients
having chronic myocardial ischemia with refractory angina showed an
average 107 second increase in exercise tolerance and an 82%
average reduction in angina episodes at the primary six-month
follow-up endpoint compared to before receiving the study
treatment.
CardiALLO Allogeneic Cell Therapy for Ischemic HFrEF
(BCDA-03)
This trial includes a 3+3 roll-in dose escalation cohort
followed by a 60-patient randomized double-blind controlled study.
The cohort receiving the lowest dose of twenty million cells was
initiated in December 2023. To date, no treatment-emergent adverse
events, arrhythmias, rejection, or allergic response have been
observed, consistent with our presentation at the Technology and
Heart Failure Therapeutics meeting on March 4, 2024.
Biotherapeutic Delivery Partnerships
The Helix transendocardial biotherapeutic delivery system is a
therapeutic-enabling platform for minimally invasive targeted
delivery of biologic agents to the heart which we use in our own
therapeutic programs. Our biotherapeutic delivery partnerships have
potential to enhance future treatment options for millions of
people suffering from heart disease, offset the costs of
biotherapeutic delivery for our own programs, and participate in
meaningful revenue sharing should our partnering efforts contribute
to successful therapeutic development.
In March 2024, we announced a biotherapeutic delivery
partnership with StemCardia through a Phase I/II Clinical Study.
Under the partnership, BioCardia is the exclusive biotherapeutic
delivery partner for StemCardia’s cell therapy candidate through
studies expected to result in FDA approval of an investigational
new drug application (IND) and the anticipated Phase I/II clinical
development to follow.
In May 2024, our biotherapeutic delivery partner CellProthera
announced their Excellent Phase 1/2b cell therapy study results in
post-myocardial infarction are expected to be presented during the
European Society of Cardiology Heart Failure Congress, May 14 to
16, 2024.
Morph® Access Innovations
Our planned Morph-DNA submission to the FDA for approval of a
product family from 5 French to 8 French diameters is on track for
submission in the second quarter of 2024 with an expected approval
in the third quarter of 2024.
First Quarter 2024 Financial Results:
- Revenues were approximately $55,000 for
the three months ended March 2024, compared to approximately
$64,000 for the three months ended March 2023.
- Research and development expenses were
approximately $1.2 million for the three months ended March 2024
compared to approximately $2.4 million for the three months ended
March 2023 following the completion of enrollment in the CardiAMP
Cell Therapy Heart Failure Trial in the second half of 2023.
- Selling, general and administrative
expenses were approximately $1.1 million for the three months ended
March 2024 compared to approximately $1.2 million for the three
months ended March 2023.
- Our net loss was approximately $2.3
million for the three months ended March 2024, compared to
approximately $3.5 million for the three months ended March
2023.
- Net cash used in operations for the
three months ended March 2024 was approximately $1.5 million, as
compared to approximately $2.6 million for the three months ended
March 2023.
ANTICIPATED UPCOMING MILESTONES AND EVENTS:
- CardiAMP Cell Therapy for Ischemic
Heart Failure of Reduced Ejection Fraction (BCDA-01)
- Q2: Enrollment in the CardiAMP Cell
Therapy Heart Failure Trial
- Q3: Japan’s PMDA consultation
- Q4: Final data from the CardiAMP Cell
Therapy Heart Failure Trial
- Q4: Submission of clinical data to
Japan’s PMDA
- CardiAMP Cell Therapy for Chronic
Myocardial Ischemia (BCDA-02)
- 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
- 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
About BioCardia®
BioCardia, Inc., headquartered in Sunnyvale, California, is
developing cellular and cell-derived therapeutics for the treatment
of cardiovascular and pulmonary disease. CardiAMP™ autologous and
NK1R+ allogeneic cell therapies are the Company’s biotherapeutic
platforms that enable four product candidates in development.
BioCardia also partners with other biotherapeutic companies to
provide its delivery systems and development support to their
programs studying therapies for the treatment of heart failure,
chronic myocardial ischemia and acute myocardial infarction. The
CardiAMP Cell Therapy Trial for Heart Failure has been supported
financially by the Maryland Stem Cell Research Fund and the Center
for Medicare and Medicaid Services. For more information
visit: https://www.BioCardia.com.
Conference call access:
Participants can register for the conference by navigating to
https://dpregister.com/sreg/10189148/fc87734564. 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
and ask to be connected to the BioCardia call. 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=TeAMFuE4.
A webcast replay of the call will be available approximately one
hour after the end of the call at the above links. To access the
replay internationally, please use the link
https://services.choruscall.com/ccforms/replay.html. A telephonic
replay of the call will be available and may be accessed by calling
1-877-344-7529 (domestic), 1-412-317-0088 (international) or
855-669-9658 (Canada) by using access code 5376275.
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 in our
clinical trials, the availability of data from our clinical trials,
filings and communications 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, the expected benefits of our
intellectual property, future prospects, regulatory timelines, and
other 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 the 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,” and in our subsequently
filed Quarterly Report on Form 10-Q. BioCardia expressly disclaims
any intent or obligation to update these forward-looking
statements, except as required by law.
BIOCARDIA, INC. |
|
|
|
|
|
|
Condensed Consolidated Statements of
Operations |
|
|
|
|
|
|
(Unaudited In thousands, except share and per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months endedMarch 31, |
|
|
|
|
2024 |
|
|
2023 |
|
Revenue: |
|
|
|
|
|
|
|
Collaboration agreement revenue |
$ |
55 |
|
$ |
64 |
|
Costs and expenses: |
|
|
|
|
|
|
|
Research and development |
|
1,241 |
|
|
2,384 |
|
|
Selling, general and administrative |
|
1,089 |
|
|
1,190 |
|
|
|
Total costs and expenses |
|
2,330 |
|
|
3,574 |
|
|
|
Operating loss |
|
(2,275 |
) |
|
(3,510 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
Total other income, net |
|
8 |
|
|
9 |
|
Net loss |
$ |
(2,267 |
) |
$ |
(3,501 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted |
$ |
(0.09 |
) |
$ |
(0.17 |
) |
|
|
|
|
|
|
|
|
|
Weighted-average shares used in computing |
|
|
|
|
net loss per share, basic and diluted |
|
25,133,093 |
|
|
20,177,167 |
|
|
|
|
|
|
|
|
|
|
BioCardia, Inc. |
|
|
|
|
|
|
|
Selected Balance Sheet Data |
|
|
|
|
|
|
|
(amounts in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
|
December 31, |
|
|
|
2024(1) |
|
|
|
2023(1) |
|
|
|
|
|
|
|
|
|
Assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
949 |
|
|
$ |
1,103 |
|
Other current assets |
|
310 |
|
|
|
358 |
|
Property, plant and equipment and other noncurrent assets |
|
1,420 |
|
|
|
1,526 |
|
Total assets |
$ |
2,679 |
|
|
$ |
2,987 |
|
Liabilities and Stockholders’ Deficit |
|
|
|
|
|
|
|
Current liabilities |
$ |
4,071 |
|
|
$ |
3,608 |
|
Operating lease liability - noncurrent |
|
883 |
|
|
|
982 |
|
Total stockholders’ deficit |
|
(2,275 |
) |
|
|
(1,603 |
) |
Total liabilities and stockholders’ deficit |
$ |
2,679 |
|
|
$ |
2,987 |
|
|
|
|
|
|
|
|
|
(1) March 31, 2024 amounts are unaudited. December 31, 2023 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. |
Media Contact:
Miranda Peto, Marketing / Investor Relations
Email: mpeto@BioCardia.com
Phone: 650-226-0120
Investor Contact:
David McClung, Chief Financial Officer
Email: investors@BioCardia.com
Phone: 650-226-0120
Grafico Azioni BioCardia (NASDAQ:BCDA)
Storico
Da Mag 2024 a Giu 2024
Grafico Azioni BioCardia (NASDAQ:BCDA)
Storico
Da Giu 2023 a Giu 2024