BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and
cell-derived therapeutics for the treatment of cardiovascular and
pulmonary diseases, today reports financial results for the third
quarter of 2023 and filed its quarterly report on Form 10-Q for the
three and nine months ended June 30, 2023 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.
“We have increased confidence in the potential of our autologous
CardiAMP Cell Therapy program in ischemic heart failure based on
the recent interim data from 136 procedures and in Chronic
Myocardial Ischemia based on the first four patients enrolled. We
are also focused strategically on advancing these two clinical
programs in a cash neutral fashion with the benefit of the Medicare
reimbursement obtained previously. Similarly, we are working to
secure grants and partnerships around our allogeneic programs to
support their clinical development, and implementing a recurring
revenue biotherapeutic delivery partnering model with our
experienced world class team and our Helix biotherapeutic delivery
system” said Peter Altman, President and CEO of BioCardia. “The
success of these efforts will be evidenced by reductions to our net
loss with increases in partnering and grant revenues, while
delivering significant clinical data on our therapeutic
candidates.”
RECENT BUSINESS HIGHLIGHTS:
CardiAMP® Autologous Cell Therapy for Patients with
Ischemic Heart Failure (BCDA-01)
The CardiAMP Cell Therapy Trial for Heart Failure is an ongoing
randomized, double-blinded, controlled clinical trial in the United
States that was approved for up to 260 patients at up to 40
clinical centers. On July 21, 2023, the study’s Data Safety
Monitoring Board (DSMB) recommended that enrollment in the trial be
paused based on an analysis of trial data and the primary endpoint
assessment, unrelated to any emergent safety events, and pending an
outcome analysis of patients currently completing one year
follow-up as well as the interim results of newly enrolled patients
completing their imminently scheduled treatment. Further, the DSMB
recommended that the blind not be broken to protect the integrity
of the outcomes yet to be collected and to ensure the study may be
restarted without compromise after completion of the one-year data
analysis.
The Company has determined that it would be difficult, if not
impossible, to restart the trial as currently designed after
completing the one-year data analysis in the fourth quarter of
2024. During the third quarter of 2023, BioCardia worked with
the DSMB to unblind a small committee within the Company to review
the closed session DSMB report of interim study results to better
understand the rationale behind their recommendation. After
reviewing the interim dataset as presented to the DSMB, along with
the finding that the primary endpoint at one year was unlikely to
be met with the current study design, management concurs with the
DSMB recommendation to follow patients through one-year follow-up,
while maintaining the study double-blind to protect the integrity
of the outcomes yet to be collected for the one-year data analysis
anticipated late next year.
In the interim data from the July DSMB review, 102 randomized
patients in the CardiAMP Cell Therapy trial followed for up to 24
months showed a 37% relative risk reduction of cardiac death
equivalents and an 18% relative risk reduction in major adverse
cardiac and cerebrovascular events (MACCE).
In addition, the available interim data showed that for an
important subset of patients who presented at the
screening/baseline visit with higher levels of NT-proBNP, a
well-established biomarker of increased heart failure and stress to
the heart, the reduction in heart death equivalent and MACCE were
even greater. In patients with NT-pro BNP levels greater than 500
pg/ml at baseline, an analysis of all available data up to two
years shows improvements over controls including a 59% relative
risk reduction in mortality and a 54% relative risk reduction of
MACCE. Further, all clinical outcomes included in this subset
analysis favored cell therapy including improved quality-of-life as
measured using the Minnesota Living with Heart Failure
Questionnaire, reduction of NT-proBNP levels, greater Six Minute
Walk distance, and improved left ventricular ejection fraction,
left ventricular end systolic volume and left ventricular end
diastolic volume. Both the reduced heart death equivalents (p=.028)
and improved quality of life as measured using the Minnesota Living
with Heart Failure Questionnaire (p=0.016) demonstrated statistical
significance favoring therapy.
On October 11, 2023, after an additional four patients were
randomized subsequent to the DSMB review, the Company announced
completion of enrollment in the CardiAMP Cell Therapy Heart Failure
Trial and initiation of a discussion with the FDA on a second
pivotal study protocol adapted for the responders in the initial
trial with the objective of gaining FDA marketing approval.
BioCardia has submitted a proposed CardiAMP Heart Failure II
study protocol for FDA review, which includes an eligibility
requirement that enrolled patients have an NT-proBNP at baseline
greater than 500 pg/ml. The proposed primary endpoint is also
modified from the primary endpoint in the currently ongoing study.
The new endpoint proposed is a similar hierarchical composite
endpoint consisting of all-cause death, the cardiac death
equivalents of heart transplant and left ventricular assist device
(LVAD) implantation, heart failure hospitalizations, worsening
heart failure events treated as an outpatient, and change in
quality-of-life with a follow-up duration ranging from a minimum of
12 to a maximum of 24 months. Should this study protocol be
approved by the FDA and advanced by BioCardia, it may be possible
to significantly offset clinical costs with the Medicare
reimbursement of up to $20,000 now in place for both the control
and treatment arms of this investigational therapeutic study.
In June 2023, the Company completed its submission of the
CardiAMP Cell Therapy System to Japan’s Pharmaceutical and Medical
Device Agency (PMDA) towards approval for the indication of
ischemic heart failure with reduced ejection fraction (HFrEF) based
on existing safety and efficacy data. In July, the formal
consultation was reviewed and accepted by the PMDA for the
consultation with some clarifying questions, which have been
addressed. In October, the Company provided an update at PMDA’s
requests on the current Phase III study status in the United
States, and a formal consultation is scheduled for November 21,
2023. While subsequent interactions and consultations with
the PMDA are expected, the CardiAMP Cell Therapy System has
potential to be the first minimally invasive catheter-based cell
therapy available in Japan.
CardiAMP® Autologous Cell Therapy for Patients with
Chronic Myocardial Ischemia
(BCDA-02) The
CardiAMP Cell Therapy Trial for Chronic Myocardial Ischemia is a
Phase III, multi-center, randomized, double-blinded, controlled
study of up to 343 patients at up to 40 clinical sites. The
trial has been activated at two clinical sites and four patients
have been treated. The Company expects to complete the
roll-in cohort of patients in the fourth quarter of 2023 and begin
the randomized phase of the trial.
CardiALLO™ Allogeneic Cell Therapy for Ischemic HFrEF
(BCDA-03)
The CardiALLO Allogeneic Cell Therapy for Ischemic HFrEF is a
first-in-human Phase I/II 69 patient clinical trial designed to
patients with New York Heart Association Class II and III ischemic
heart failure with ischemic HFrEF, including those whose own cell
composition makes them ineligible for the Company’s Phase III
CardiAMP Heart Failure Trial. The first patient is expected to be
treated in the fourth quarter of 2023. This study follows three
previous clinical trials with MSCs cosponsored by the Company in
ischemic heart failure with 93 patients treated using the Helix
delivery system.
HelixTM Biotherapeutic Delivery System
BioCardia’s Helix Biotherapeutic Delivery System (Helix)
delivers therapeutics into the heart muscle with a penetrating
helical needle from within the heart. It enables local delivery of
cell and gene-based therapies, including BioCardia’s own cell
therapies. The delivery platform includes proprietary approved
steerable guide systems, approved delivery catheters, and
investigational imaging navigation.
The Company’s biotherapeutic delivery team has active
discussions with current and prospective partners regarding
programs utilizing the Helix platform and expects to finalize up to
two licensing and development relationships during the fourth
quarter of this year. These relationships are intended to
share the costs of ongoing maintenance of and advances in the
valuable enabling platform, and for BioCardia shareholders to
benefit from the future success of these partnered programs. In
September, CellProthera announced completion of enrollment in the
Phase I/II cell therapy study in post-myocardial infarction.
Third Quarter 2023 Financial Results:
- Revenues were approximately $357,000 for the three months ended
September 2023, compared to approximately $212,000 for the three
months ended September 2022.
- Research and development expenses were approximately $1.9
million for the three months ended September 2023, compared to
approximately $2.1 million for the three months ended September
2022.
- Selling, general and administrative expenses were approximately
$1.1 million for the three months ended September 2023 and for the
three months ended September 2022.
- Our net loss was approximately $2.6 million for the three
months ended September 2023, compared to approximately $3.1 million
for the three months ended September 2022.
- Net cash used in operations for the three months ended
September 2023 was approximately $2.4 million, as compared to
approximately $2.0 million for the three months ended September
2022.
ANTICIPATED UPCOMING MILESTONES AND EVENTS:
- BCDA-01: CardiAMP Cell Therapy for Heart Failure Phase III
Trials
- Q4 2023: CardiAMP HF Trial II FDA Protocol Approval
- Q4 2023: Japan PMDA Formal Consultation
- BCDA-02: CardiAMP Cell Therapy for Chronic Myocardial Ischemia
Phase III Trial
- Q4 2023: Completion of Roll-in Cohort and Transition to
Randomized Pivotal Trial
- BCDA-03: NK1R+ MSC Allogeneic Cell Therapy in Ischemic HFrEF
Phase I/II Trial
- Q3 2023: Completion of Low Dose Cohort
- Helix Biotherapeutic Delivery System
- Q4 2023: Update on Licensing / Partnerships
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: www.BioCardia.com.
Conference call access:
Participants can register for the conference by navigating to
https://dpregister.com/sreg/10184161/faf88f5b32. 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=bPAksYvP.
A webcast replay of the call will be available approximately one
hour after the end of the call at the above links. 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 8151652.
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, the future prospects for BCDA-01 and the
regulatory timeline and process associated with such trial, 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 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 29, 2023,
under the caption titled “Risk Factors,” and in our subsequently
filed Quarterly Reports 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 Statements of
Operations |
(Unaudited In thousands, except share and
per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months ended
September 30, |
|
|
Nine Months ended
September 30, |
|
|
|
|
|
2023 |
|
|
2022 |
|
|
|
2023 |
|
|
2022 |
|
Revenue: |
|
|
|
|
|
|
Net product
revenue |
$ |
— |
|
$ |
2 |
|
|
$ |
— |
|
$ |
3 |
|
|
Collaboration
agreement revenue |
|
357 |
|
|
210 |
|
|
|
464 |
|
|
1,243 |
|
|
|
Total revenue |
|
357 |
|
|
212 |
|
|
|
464 |
|
|
1,246 |
|
Costs and
expenses: |
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
1,872 |
|
|
2,144 |
|
|
|
6,570 |
|
|
6,634 |
|
|
Selling, general
and administrative |
|
1,083 |
|
|
1,128 |
|
|
|
3,454 |
|
|
3,495 |
|
|
|
Total costs and
expenses |
|
2,955 |
|
|
3,272 |
|
|
|
10,024 |
|
|
10,129 |
|
|
|
Operating
loss |
|
(2,598 |
) |
|
(3,060 |
) |
|
|
(9,560 |
) |
|
(8,883 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
|
Total other
income, net |
|
24 |
|
|
3 |
|
|
|
61 |
|
|
4 |
|
Net loss |
$ |
(2,574 |
) |
$ |
(3,057 |
) |
|
$ |
(9,499 |
) |
$ |
(8,879 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share, basic and diluted |
$ |
(0.12 |
) |
$ |
(0.17 |
) |
|
$ |
(0.46 |
) |
$ |
(0.51 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
shares used in computing |
|
|
|
|
|
|
|
|
|
|
net loss per
share, basic and diluted |
|
21,615,655 |
|
|
17,844,991 |
|
|
|
20,731,050 |
|
|
17,523,837 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BioCardia,
Inc. |
|
|
|
|
|
|
Selected Balance Sheet
Data |
|
|
|
|
|
|
(amounts in
thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
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|
September 30, |
|
|
December 31, |
|
|
|
2023(1) |
|
|
2022(1) |
|
|
|
|
|
|
|
|
Assets: |
|
|
|
|
|
|
Cash and cash equivalents |
$ |
1,835 |
|
|
$ |
7,363 |
|
Other current assets |
|
281 |
|
|
|
501 |
|
Property, equipment and other
noncurrent assets |
|
1,631 |
|
|
|
1,929 |
|
Total assets |
$ |
3,747 |
|
|
$ |
9,793 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
Current liabilities |
$ |
3,330 |
|
|
$ |
3,585 |
|
Operating lease liability -
noncurrent |
|
1,077 |
|
|
|
1,316 |
|
Total stockholders’ equity
(deficit) |
|
(660 |
) |
|
|
4,892 |
|
Total liabilities and
stockholders’ equity (deficit) |
$ |
3,747 |
|
|
$ |
9,793 |
|
|
|
|
|
|
|
|
(1) September 30, 2023 amounts are unaudited. December
31, 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, 2022, filed with the U.S.
Securities and Exchange Commission on March 29, 2023. |
|
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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
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