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 second
quarter of 2023 and filed its quarterly report on Form 10-Q for the
three and six 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 followed the recent recommendation from our Data Safety
Monitoring Board (DSMB) to pause enrollment of new patients in our
autologous cell therapy trial for ischemic heart failure or
BCDA-01, even as there were no treatment emergent safety issues
reported, patients in aggregate appear to be showing clinical
improvements, and enrollment had accelerated in recent months. We
continue to randomize and monitor patients enrolled in this
clinical study. Unblinded statistics and clinical consultants are
reviewing the primary endpoint analysis and secondary outcome
measures. Potential next steps in Q3 include discussions between
the DSMB and the consultancies before BioCardia unblinds itself to
the interim data,” said Peter Altman PhD. “As we work through this
process for BCDA-01, we expect important milestones for our other
clinical programs. We look forward to completion of enrollment for
the roll-in cohort of the Phase III trial of our autologous cell
therapy for patients with chronic myocardial ischemia or BCDA-02,
as well as treatment of the first patients in the Phase I/II
clinical trial of our allogeneic mesenchymal stem cell therapy for
ischemic heart failure or BCDA-03. Business development is active
around our Helix biotherapeutic delivery platform and in other
areas, and we are working to close two meaningful deals by the end
of the year.”
RECENT BUSINESS HIGHLIGHTS:
CardiAMP® Autologous Cell Therapy for Patients with
Ischemic Heart Failure (BCDA-01)
The CardiAMP Cell Therapy Trial for Heart Failure is a Phase
III, multi-center, randomized, double-blinded, sham-controlled
study intended to include up to 260 patients. The Phase III pivotal
trial, which was granted Breakthrough designation by the U.S. Food
and Drug Administration (FDA), is designed to provide the primary
support for the safety and efficacy of the CardiAMP Cell Therapy
System for the treatment of heart failure with reduced ejection
fraction (HFrEF).
On July 12, 2023, the planned Data Safety Monitoring Board
(DSMB) meeting was held utilizing the adaptive statistical analysis
plan reviewed by FDA in the second quarter. On July 24, 2023, the
Company announced that the DSMB had completed its review and
recommended that the Company pause the trial pending the one-year
follow-up outcomes analysis for patients that have been treated and
those that have been enrolled but not yet treated.
The DSMB reviewed an initial analysis of the unblinded data and
concluded that the trial was unlikely to meet its primary FS
composite endpoint, even though the prespecified criteria for
termination of the trial had not been met. This initial analysis
excluded patients who had not yet made it to 12-month follow-up.
The DSMB also cited the slow rate of enrollment in the trial.
Additional data was subsequently provided to the DSMB, which the
Company understands included: (1) statistical analysis prepared
strictly in accordance with the prespecified data review plan,
which had not initially been provided to the DSMB, (2) analysis of
health outcomes as measured by endpoints other than the six-minute
walk, and (3) information on the increased enrollment rates across
many clinical centers. After consideration of the additional data,
the DSMB recommended that the Company pause enrollment of new
patients pending the 12-month outcomes analysis for all patients,
and that the Company continue to treat patients already enrolled in
the trial. The DSMB also recommended that the data blind be
preserved so that the trial may be continued following analysis of
the 12-month follow-up data for all enrolled patients.
The blinded aggregate data for the 96 randomized patients with
12-month outcome measures available for the most recent DSMB review
showed better-than-expected patient survival, improvement in mean
six-minute walk distance, improvement in NYHA class, improvement in
quality of life and improvement in left ventricular ejection
fraction. The DSMB reported that there were no treatment emergent
safety concerns in the study. An estimated additional 25 randomized
patients will be included in final trial results should the trial
not be restarted. This estimate includes 10 patients in the queue
expected to be randomization in the trial in the next six weeks,
nine randomized patients who have not yet reached the 12-month
follow-up visit, and six patients who were unable to walk at 12
months due to other non-cardiac issues. Results will not be
available until the last patient reaches their 12-month follow-up
visit.
An external statistics consultancy has completed a quality
review on the primary endpoint interim data analysis provided to
the DSMB to confirm they had accurate information. The company is
working to enable this replicate analysis and the closed session
DSMB information to be reviewed by a clinical consultant to make
recommendations on next steps. If there are reasons to engage the
DSMB, discussions between the DSMB and the unblinded consultants
may take place. Once this quality review is completed by this
external unblinded group, expected in the third quarter 2023, it is
anticipated that a segregated BioCardia team will be unblinded to
the data in order to provide strategic guidance for this program
ahead. If the Company obtains material new information from this
review, it will be shared publicly as appropriate.
In June 2023, the Company completed its submission of the
CardiAMP Cell Therapy System to Japan’s Pharmaceutical and Medical
Device Agency (PMDA) for a first formal consultation 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. The PMDA consultation could take up to four
months to schedule per their normal review process, although dates
in September have been requested. Subsequent interactions with PMDA
are expected. If approved, 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 intended to include up to 343 patients at up to 40
clinical sites. The Company expects to complete enrollment in the
roll-in cohort of five patients in the fourth quarter of 2023 and
begin the randomized phase of the trial. Planning for the
randomization phase is already underway based on promising
experience in the patients treated to date. Strategies of using the
cell population analysis as a means to set patient dosing as
opposed to excluding patients, and means to include more patients
based on modifying baseline exclusion criteria, are under
consideration to enable more rapid enrollment. Six additional
centers are actively being onboarded.
CardiALLO™ Allogeneic Cell Therapy for Ischemic HFrEF
(BCDA-03)
In December 2022, the FDA approved the Company’s
Investigational New Drug (IND) application to initiate a
first-in-human Phase I/II clinical trial encompassing 69 patients
with HFrEF treated with the Company’s allogeneic cells. Clinical
grade cells have been manufactured at BioCardia and are ready for
use with the Company’s proprietary delivery system, also
manufactured at BioCardia. The first clinical center has finalized
its clinical study agreement and received conditional IRB approval.
Cellular preparation test runs at the clinical site and site
activation visit is scheduled for this month. Patient enrollment is
expected to begin in the third quarter.
This study builds on three previous trials of
mesenchymal stem cells (MSC) in ischemic heart failure using the
Company’s proprietary Helix™ delivery system encompassing 93
patients treated with culture expanded MSCs with no treatment
emergent serious adverse events. Previous trial results showed
compelling early signals for benefit that this trial is expected to
build upon.
Allogeneic Cell Therapy for Acute Respiratory Distress
Syndrome (BCDA-04)
The Company’s Allogeneic Cell Therapy Trial for Acute
Respiratory Distress Syndrome (ARDS) has been deprioritized to
focus current financial resources on other programs. This decision
was based on the greatly reduced population of patients with acute
respiratory distress secondary to COVID. When resources permit,
BioCardia intends to expand the current indication to a broader
ARDS population beyond COVID and to other pulmonary
indications.
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. It remains the safest, easiest to use, and most
efficient means for the delivery of cells, genes, and proteins to
the heart muscle. The delivery platform includes proprietary
approved steerable guide systems, approved delivery catheters, and
investigational imaging navigation.
The Company’s Helix team has active discussions with current and
prospective partners regarding programs utilizing the Helix
platform. 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.
Intellectual Property
In June, the Company announced that the Japan Patent Office
granted Patent No: JP7282649B2 titled “Radial and Transendocardial
Delivery Catheter” with a patent term that will expire on September
30, 2034. The patent describes interventional biotherapeutic
delivery catheters to deliver biologics to specific target sites
from within the heart chamber. The allowed claims cover
BioCardia’s helical needle tipped catheter technology platform in
existing products and in future products in active development with
enhanced features.
Also in June, the European Patent Office issued an Intention to
Grant a patent titled: “Site Selection, Entry, And Update with
Automatic Remote Inage Annotation.” The patent application
describes techniques to bring previously obtained high-resolution
three dimensional images of a patient's heart, such as from an MRI
into the cardiac catheterization procedure suite, and to merge this
image with the X-ray images that the physician uses to navigate
during the procedure. This approach has been compelling in
preclinical studies and is expected to further enhance targeting,
ease of procedure, and data collection compared to our current
procedures.
Second Quarter 2023 Financial Results:
- Revenues were approximately $43,000 for
the three months ended June 2023, compared to approximately
$974,000 in the three months ended June 2022, due primarily to the
timing of collaboration agreement revenues.
- Research and development expenses were
approximately $2.3 million for the three months ended June 2023 and
for the three months ended June 2022.
- Selling, general and administrative
expenses were approximately $1.2 million for the three months ended
June 2023 and for the three months ended June 2022.
- Our net loss was approximately $3.4
million for the three months ended June 2023, compared to
approximately $2.5 million for the three months ended June 2022,
due primarily to the timing of collaboration agreement
revenues.
- Net cash used in operations for the
three months ended June 2023 was approximately $3.2 million, as
compared to approximately $2.6 million for the three months ended
June 2022.
ANTICIPATED UPCOMING
MILESTONES AND EVENTS:
- BCDA-01: CardiAMP Cell Therapy for
Heart Failure Phase III Trial
- Q3 2023: Finalize External Review of
Interim Data and DSMB Recommendation
- 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: First Patient Enrolled
- Helix Biotherapeutic Delivery System
- Q4 2023 Completion of Enrollment in
Partner CellProthera’s EXCELLENT Trial
- Q4 2023: Update on Licensing /
Partnerships
About BioCardia®
BioCardia, Inc., headquartered in Sunnyvale, California, is a
developer of two biotherapeutic platforms – the
CardiAMP autologous bone marrow derived mononuclear cell
therapy for cardiovascular indications, and the NK1R+ allogeneic
bone marrow derived mesenchymal stem cell therapy for
cardiovascular and pulmonary diseases. These platforms underly
four product candidates, each with the potential to meaningfully
benefit millions of patients. Three of BioCardia’s investigational
therapies are enabled by the Company’s proprietary biotherapeutic
delivery platform, which the Company also selectively licenses to
other biotherapeutic development firms. 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/10181574/fa1ff8fef0. 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=IBDjLUv7.
A webcast replay of the call will be available approximately one
hour after the end of the call through November 9, 2023, at the
above links. A telephonic replay of the call will be available
through August 23, 2023 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 7514640 or by the link:
https://event.choruscall.com/mediaframe/webcast.html?webcastid=IBDjLUv7.
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 June 30, |
|
|
Six Months ended June 30, |
|
|
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
Net product revenue |
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
1 |
|
|
|
Collaboration agreement revenue |
43 |
|
|
|
974 |
|
|
|
107 |
|
|
|
1,033 |
|
|
|
|
Total revenue |
|
43 |
|
|
|
974 |
|
|
|
107 |
|
|
|
1,034 |
|
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
2,314 |
|
|
|
2,304 |
|
|
|
4,698 |
|
|
|
4,490 |
|
|
|
Selling, general and administrative |
1,181 |
|
|
|
1,166 |
|
|
|
2,371 |
|
|
|
2,367 |
|
|
|
|
Total costs and expenses |
3,495 |
|
|
|
3,470 |
|
|
|
7,069 |
|
|
|
6,857 |
|
|
|
|
Operating loss |
|
(3,452 |
) |
|
|
(2,496 |
) |
|
|
(6,962 |
) |
|
|
(5,823 |
) |
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other
income (expense), net |
|
|
28 |
|
|
|
(1 |
) |
|
|
37 |
|
|
|
1 |
|
|
Net loss |
|
$ |
(3,424 |
) |
|
$ |
(2,497 |
) |
|
$ |
(6,925 |
) |
|
$ |
(5,822 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted |
|
$ |
(0.17 |
) |
|
$ |
(0.14 |
) |
|
$ |
(0.34 |
) |
|
$ |
(0.34 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares used in computing |
|
|
|
|
|
|
|
|
net loss per share, basic and diluted |
|
|
20,384,522 |
|
|
|
17,651,892 |
|
|
|
20,281,417 |
|
|
|
17,360,598 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BioCardia, Inc. |
|
|
|
|
|
Selected Balance Sheet Data |
|
|
|
(amounts in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2023(1) |
|
|
2022(1) |
|
|
|
|
|
|
|
|
Assets: |
|
|
|
|
|
|
Cash and
cash equivalents |
$ |
4,305
|
|
$ |
7,363
|
|
Other
current assets |
|
345
|
|
|
501
|
|
Property,
equipment and other noncurrent assets |
|
1,739
|
|
|
1,929
|
|
Total
assets |
$ |
6,389 |
|
$ |
9,793 |
|
Liabilities and Stockholders’ Equity |
|
|
Current
liabilities |
$ |
3,616
|
|
$ |
3,585
|
|
Operating
lease liability - noncurrent |
|
1,138
|
|
|
1,316
|
|
Total
stockholders’ equity |
|
1,635
|
|
|
4,892
|
|
Total
liabilities and stockholders’ equity |
$ |
6,389 |
|
$ |
9,793 |
|
|
|
|
|
|
|
|
(1) June 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. |
|
|
|
|
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 (NASDAQ:BCDA)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
BioCardia (NASDAQ:BCDA)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024