BioCardia, Inc. (Nasdaq: BCDA), a developer of cellular and
cell-derived therapeutics for the treatment of cardiovascular and
pulmonary diseases, issues the following letter to shareholders:
Dear Shareholders,
BioCardia completed 2023 with three active clinical programs of
its autologous and allogeneic cell therapies to treat heart
disease, with a focus on ischemic heart failure of reduced ejection
fraction. We expect to report clinical data from each of these
programs in 2024. In coming months, we will provide a more detailed
update on our therapeutic pipeline including expected timelines for
data readouts and regulatory milestones.
Today, I am writing to share a brief update on our business
development activities related to our Biotherapeutic Delivery
Partnering (BDP) business and our Morph Access Innovations (Morph)
business. Our BDP efforts are enhanced by the experience of almost
500 patients treated with the Helix transendocardial biotherapeutic
delivery systems in twelve clinical trials. Morph products are used
in each of our biotherapeutic delivery procedures, and have been
used in thousands of vascular procedures over the years. The BDP
and Morph businesses are derived from the experience and technology
that we have developed in support of our own autologous and
allogeneic cell therapy platforms.
In BDP, our team provides support for pre-clinical and clinical
stage programs to enable and enhance our partner’s biotherapeutic
development efforts. Efforts include review and preparation of
protocols, sharing of strategic and regulatory insights, and
providing technical input on strategies for handling and delivering
biologic agents. We provide protocols and data collection templates
as well as catheter products and technologies that are available
today. We perform training for staff and physicians and support
procedures using our biotherapeutic delivery systems. We believe
that BioCardia having more opportunities to participate
meaningfully in new high-value therapies through BDP is in our
shareholders’ interests and outweighs concerns with respect to
enabling competitive therapeutic programs.
We have two new biotherapeutic delivery partnerships we
anticipate finalizing soon based on terms agreed upon in December
2023. Both potential partners have extensive positive large animal
experience with our delivery systems, as do a number of additional
potential partners. We have the ability to fully support several of
these partners, sharing our knowledge, experience and technology to
help advance their efforts.
We have also been active in partnering discussions for our Morph
products for markets where our products and technologies enable
high value therapies beyond biotherapeutic intervention. These
markets include transseptal access, radial access coronary and
peripheral procedures, and aorto-ostial access procedures. Our
previous product experience in thousands of clinical procedures has
led us to our recent Morph DNA™ designs. These bidirectional
steerable sheath introducers and guide designs underlie our Avance™
transseptal steerable introducers. Currently, we have several
larger firms performing active diligence towards potential Morph
partnerships.
Our BDP and Morph partnering efforts are enhanced by both the
performance of our offerings in our clinical programs and our
extensive intellectual property portfolio. We have had recent
patent issuances in Japan and EU that are in our partner’s
interests. On October 7th, 2023, Japan’s Patent Office issued
Patent No. 737497, and on December 13, 2023, the European Patent
Office Issued Patent No. 2943123, both of which are titled, “Target
site selection, entry and updates with automatic remote image
annotation”. These patents claim ownership of inventions for how an
interventional cardiologist working in the chambers of the heart
may navigate relative to an imported echo, MRI, or CT image which
have been obtained noninvasively prior to the procedure. Our
inventive focus has been the targeting of biologic therapies, but
the patent impact may be broader. This fusion imaging software
approach is anticipated to be a significant product enhancement for
our biotherapeutic delivery capabilities and regulated as software
as a medical device. There are also recently published patent
applications on both our Helix biotherapeutic delivery systems and
our Morph steerable access technology that we continue to
advance.
The coming year offers the potential for catalysts that could
dramatically improve our prospects, timetable, and attractiveness
as a business, both from our therapeutic programs themselves and
from the technologies we have developed to advance these
therapeutic programs. We are excited about what the future holds
and are grateful for the opportunity to create an entirely new
class of heart failure treatments and transform cardiovascular
care. I look forward to sharing material news as it happens.
Thank you for your continued support, which makes everything we
do possible.
Sincerely yours,
Peter A. Altman, Ph.D.President and Chief Executive Officer,
BioCardia, Inc.
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
CardiALLO allogeneic cell therapies are the Company’s
biotherapeutic platforms for the treatment of heart disease.
BioCardia also acts as a biotherapeutic delivery partner supporting
therapies for the treatment of heart failure, chronic myocardial
ischemia and acute myocardial infarction. 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 advancing our four
clinical programs, biotherapeutic delivery partnerships, and Morph
steerable sheath and guide partnerships, 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. 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. Factors that could cause or contribute to such
differences include, but are not limited to, the Company’s
liquidity position and its ability to raise additional funds, as
well as the Company’s ability to successfully progress its clinical
trials. 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 its 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.
Media Contact:
Miranda Peto, Marketing
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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