SUNNYVALE, Calif., March 24, 2026 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the year ended December 31, 2025 and filed its annual report on Form 10-K with the Securities and Exchange Commission.
The Company will host a corporate update conference call today, on Tuesday, March 24, 2026, at 4:30 PM ET, in which it will discuss business highlights. Call details and dial-in are provided below.
Recent Business Highlights
CardiAMP$(R)$ autologous cell therapy in ischemic heart failure of reduced ejection fraction (BCDA-01)
In parallel to advancing the regulatory discussions with the USA FDA and Japan PMDA on the potential market release of the CardiAMP System for the treatment of ischemic heart failure, we are advancing the confirmatory CardiAMP HF II Trial.
-- In October and November, the first enrollment in the CardiAMP HF II
clinical study began at University of Wisconsin at Madison and Henry Ford
Health System in Detroit MI, respectively. Emory University in Atlanta,
GA was also activated as a study site. With BayCare Morton Plant Mease
hospital in Clearwater, Florida, four centers are actively enrolling in
this study.
-- In December, Japan's Pharmaceutical and Medical Device Agency (PMDA)
granted a preliminary clinical consultation on the acceptability of the
existing CardiAMP HF clinical data for submission of an application for
approval with post marketing studies. PMDA has subsequently scheduled our
formal clinical consultation. In preparation for our formal consultation,
we have answered several series of additional thoughtful questions
regarding safety and efficacy of the CardiAMP Cell Therapy.
-- In March, the CardiAMP HF echocardiography clinical results measured by
the blinded core laboratory at the Yale University Cardiovascular
Research Group were presented at the Late Breaking Clinical trial session
at the Technology and Heart Failure Therapeutics conference in Boston,
Massachusetts. These results showed positive evidence of decreased
pathological left ventricular remodeling over time in patients receiving
CardiAMP cell therapy treatment compared to patients not receiving the
treatment. These results correlated to findings for the trial primary and
key secondary endpoints of reduced fatal and non-fatal major adverse
cardiovascular events and improved quality of life measures for treated
patients. The Yale core laboratory measured both left ventricular end
diastolic volume indices, when the heart ventricle is fully dilated (p =
0.06), and the left ventricular end systolic volume, when the heart is
fully contracted (p=0.09). For the prespecified subgroup of patients
having elevated biomarkers of heart stress, the differences between the
treated and control patients were both clinically meaningful (>20ml/m2
and 15 ml/m2, respectively) and statistically significant (p = 0.02 and p
= 0.01, respectively).
-- This first quarter of 2026, we have submitted the manuscript providing
all the details on the CardiAMP HF study for peer review.
-- In the USA, we expect to soon file a Q-Sub request with FDA Center for
Biologics Evaluation and Research (CBER) on approvability of the CardiAMP
System based on its safety and signals of benefit in patients with
elevated biomarkers of heart stress from our three clinical trials. This
discussion is expected to focus on our FDA approved CardiAMP CS cell
processing platform to extend labelling to a therapeutic indication for
ischemic HFrEF, as its dedicated Helix transendocardial delivery catheter
has a Pre-Submission packet actively under review by FDA Center for
Devices and Radiological Health (CDRH).
-- In Japan, we expect to soon have our formal clinical consultation to
align with PMDA on the acceptability of the existing clinical data from
our three trials for CardiAMP System submission for Shonin approval.
CardiAMP autologous cell therapy in chronic myocardial ischemic with refractory angina (BCDA-02)
-- Results from the 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. Primary results of this cohort were
submitted for presentation at Euro PCR, a world-leading course in
interventional cardiovascular medicine, in May of 2026.
CardiALLO Cell Therapy in Ischemic Heart Failure (BCDA-03)
-- The low dose cohort of 20 million cells has been completed and there have
been no treatment-emergent adverse events, arrhythmias, rejection, or
allergic response. The Data Safety Monitoring Board has recommended that
the study proceed as designed based on the 30-day data safety assessment
from this cohort.
-- Phase 2 development is anticipated to be advanced in both the United
States and Japan and would also enroll in approximately one year. It is
expected that after the completion of this Phase 2 study that conditional
approval in Japan may be pursued followed by a post-marketing study over
a period of five years to further add to the evidence of safety and
patient benefit.
-- We intend to fund development of our CardiALLO MSC program through
nondilutive grants and partnering. The Small Business Innovation Research
(SBIR) and Small Business Technology Transfer (STTR) programs expired
September 30, 2025, with our grant application before it. These were
reauthorized on March 17th by the House and Senate and are expected to
pass into law this month. We are hopeful that this will provide clarity
on this funding path for this important program and the technologies that
underlie it.
-- Our clinical grade mesenchymal stem cells are believed to be
substantially equivalent and possibly superior to other mesenchymal stem
cells currently approved for clinical indications with simple intravenous
delivery. The route of administration and dosing are near identical to
our approved Investigational New Drug Application for Acute Respiratory
Distress Syndrome. We welcome partnering discussions on this cell therapy
technology platform and our extensive intellectual property which has
applications in indications we are unable to pursue. We have had
discussions with other companies with respect to these opportunities.
Helix$(TM)$ Biotherapeutic Delivery System
-- In February 2026, we announced a Pre-Submission to FDA under its
Q-Submission program for the approval of its Helix Transendocardial
Delivery Catheter (Helix) for intramyocardial therapeutic and diagnostic
agent delivery. The data supporting safety and effectiveness for the
Helix Pre-Submission is from fifteen clinical trials of cell and gene
therapy delivery to the heart using Helix, where patients were enrolled
in three primary cardiac clinical indications.
-- FDA has accepted the Helix Pre-Submission and has confirmed that it
contains all the necessary elements and information needed to proceed
with substantive review. We are scheduled to meet with the FDA in the
second quarter of 2026, after receiving written feedback in advance. We
expect that the FDA Center for Devices and Radiological Health (CDRH)
will lead the review in consultation with the FDA Center for Biologics
Evaluation and Research (CBER). The FDA has acknowledged to us that the
CBER Breakthrough Designation on Helix enables CardiAMP Cell Therapy for
ischemic heart failure.
"We are at an important juncture of advancing our confirmatory CardiAMP HF II trial while we explore approvals based on the strength of the results in our completed trials for our autologous cell therapy for the treatment of ischemic HFrEF," said BioCardia CEO Peter Altman, Ph.D. "The risk benefit profile for patients with elevated markers of heart stress is compelling, particularly as they have few therapeutic options. The marketing clearances we seek would enable us to capture additional clinical evidence on the performance of therapy and patient responses in a real-world setting. BioCardia's additional therapeutic programs with promising clinical data, our best-in-class cardiac biotherapeutic delivery system, and our Morph DNA product portfolio also have potential to add value for shareholders and patients alike in the year ahead."
2025 Financial Results:
-- Net cash used in operations was approximately $7.4 million during the
year ended 2025, compared to approximately $7.9 million in 2024,
primarily due to the timing of supplier payments. The Company ended the
year with cash and cash equivalents totaling approximately $2.5 million.
-- There were no revenues in 2025, compared to $58,000 in 2024, due
primarily to the fulfillment of performance obligations for several
business partners.
-- Research and development expenses increased to approximately $5.0 million
in 2025, compared to approximately $4.4 million in 2024, primarily due to
closeout activities in the CardiAMP Heart Failure Trial, inception of
enrollment in the CardiAMP Heart Failure II Trial and regulatory
activities to advance CardiAMP in Japan.
-- Selling, general and administrative expenses decreased to approximately
$3.3 million in 2025, compared to approximately $3.7 million in 2024,
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