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BCDA - BioCardia Inc News Story

$4.01 -0.3  -7.6%

Last Trade - 12/04/21

Sector
Healthcare
Size
Micro Cap
Market Cap £47.7m
Enterprise Value £32.1m
Revenue £106k
Position in Universe 5462nd / 6841

BioCardia Update on Cell Therapy Product Development and 2021 Milestones

Tue 2nd February, 2021 1:30pm
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SAN CARLOS, Calif., Feb. 02, 2021 (GLOBE NEWSWIRE) -- BioCardia®, Inc.
(https://www.globenewswire.com/Tracker?data=4g-wAT-l2ZVgT7D7ZmCwW-0Kstd6QABkbLaYGP-JyXRBNSim3SgHXpJ63tB5TJPFBqIou9xcn93QPBkxnJF__A==) [Nasdaq:
BCDA] a leader in the development of comprehensive solutions for
cardiovascular regenerative therapies, today provides an update on its cell
therapy product development and 2021 milestones.
* BCDA-01, our CardiAMP autologous cell therapy under Phase III clinical
development for the treatment of ischemic heart failure remains the
Company’s top priority. The Company is targeting completion of enrollment
without requiring additional financing. The trial is expected to have its next
prespecified independent Data Safety Monitoring Board review in early Q3 2021.

* BCDA-02, our CardiAMP autologous cell therapy is under Phase III development
for the treatment of chronic myocardial ischemia. First patient enrolled in
the trial is expected in Q1 with roll in cohort safety data in 2021.

* BCDA-03, our allogenic neurokinin 1 receptor positive (NK1R+) Mesenchymal
Stem Cell (MSC) Phase I/II program follows previous Phase I/II clinical
development work with MSCs for the treatment of ischemic heart failure and is
intended initially for those patients excluded from BCDA-01. In recent
Investigational New Drug (IND) application submission interactions for this
program, the FDA has indicated comfort regarding the pharmacology and
toxicology and with the clinical plan but had continued questions related to
our chemistry, manufacturing, and controls (CMC). We are working to resolve
the outstanding issues with the agency to enable us to move forward with the
NK1R+ MSC program and target IND acceptance in 2021.

* BCDA-04, our allogenic NK1R+ MSC Phase I/II program for the treatment of
acute respiratory distress resulting from COVID-19 is on a similar timeline to
our BCDA-03 program as it utilizes substantially the same CMC. New strains of
COVID-19 may enhance the importance of this therapeutic program and we target
IND acceptance in 2021.
“This is a big year ahead for BioCardia as we advance our two pivotal
autologous cell therapy cardiac programs and ramp manufacturing activities for
our allogenic cell therapy programs,” said Peter Altman, Ph.D.,
BioCardia’s CEO. “Recent results in the field have enhanced recognition
for our technological and strategic approach to autologous cardiac cell
therapy with the CardiAMP Cell Potency Assay to reduce patient variability,
trial designs targeting patient populations sick enough to benefit greatly but
not so ill that comorbidities drive outcomes, and the use of our leading Helix
transendocardial biotherapeutic delivery system for enhanced dosage
efficiency. The Helix system, used in all three of our cardiac programs, is
also anticipated to see greater usage by partners in the year ahead.”

About BioCardia

BioCardia, Inc.
(https://www.globenewswire.com/Tracker?data=4g-wAT-l2ZVgT7D7ZmCwWxCS29xJdpRaSXGdlttMhUfcVg-RSwT4gQ5jEl4YoIl7mHS6-NAAJxPEeCz0IPLD8Q==),
headquartered in San Carlos, California, is developing regenerative biologic
therapies to treat cardiovascular and respiratory disease. CardiAMP autologous
and Neurokinin-1 Receptor Positive allogenic cell therapies are the
Company’s biotherapeutic platforms in clinical development. The Company's
products include the Helix Biotherapeutic Delivery System and its steerable
guide and sheath catheter portfolio. BioCardia also partners with other
biotherapeutic companies to provide its Helix system and clinical support for
their programs studying 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 statements
regarding our intentions, beliefs, projections, outlook, analyses, or current
expectations. Forward-looking statements include, without limitation,
statements relating to study enrollment expectations, the timing and intended
outcomes of our trials, the efficacy and safety of our products and therapies,
the timeline for and acceptance of our INDs by the FDA, the expectation of
greater usage of the Helix system by our partners, the likelihood of success
and the value of our clinical cell therapy programs and the sufficiency of
capital to pursue BioCardia’s business and product development plans and
achieve anticipated milestones. 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 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. 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 our documents filed with the Securities and Exchange
Commission, including our recent filings on Form 8-K, Form 10-K and Form 10-Q,
particularly any statements under the caption entitled “Risk Factors”
Therein. BioCardia expressly disclaims any intent or obligation to update
these forward-looking statements, except as required by law. 

INVESTOR CONTACT:
David McClung
Chief Financial Officer
investors@BioCardia.com
(650) 226-0120

MEDIA CONTACT:
Michelle McAdam
Chronic Communications, Inc.
michelle@chronic-comm.com
(310) 545-6654 

(https://www.globenewswire.com/NewsRoom/AttachmentNg/4641bb53-4913-4654-a337-79383a5c7ab9)



GlobeNewswire, Inc. 2021
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