SUNNYVALE, Calif., Nov. 12, 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 third quarter 2026 and filed its quarterly report on Form 10-Q for the three and nine months ended September 30, 2026 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 believe that our CardiAMP autologous cell therapy is on track to be the first approved minimally invasive biologic therapy for the treatment of heart failure in a first world country based on the recent interactions with Japan's Pharmaceutical and Medical Devices Agency," said Peter Altman, PhD, Chief Executive Officer of BioCardia. "In addition, in the coming months, we aim to be able to submit our Helix transendocardial delivery platform for FDA approval, which would be the first delivery system of its type approved in the United States. This promises to be an exciting year ahead."
Recent Business Highlights
CardiAMP(R) autologous cell therapy in ischemic heart failure of reduced ejection fraction (BCDA-01)
-- In November, the Company announced it had successfully completed the
process with Japan's Pharmaceuticals and Medical Devices Agency (PMDA)
concerning the application materials required to obtain regulatory
approval in Japan. Questions remaining to be addressed in advance of
submission have been addressed to PMDA's satisfaction.
-- We continue to prepare clinical data sets for submission to Japan's PMDA
and the U.S. FDA. We are working with partners to complete the electronic
trial master file, conduct good clinical practice audits, and structure
clinical research data in accordance with CDISC Standards, which support
data consistency, traceability, and regulatory compliance. We have
engaged a Designated Marketing Authorization Holder, or DMAH, as the
local regulatory representative required for foreign medical device and
pharmaceutical companies seeking to sell products in Japan without
establishing a local office. In Japan, the DMAH designation may be
transferred together with the underlying product approval.
-- BioCardia continues to actively enroll in the CardiAMP HF II trial. Four
clinical sites have enrolled in the study and are actively recruiting
patients. Seven additional world class sites are being onboarded.
-- Near term catalysts ahead for this program include publication of the
peer reviewed manuscript for CardiAMP HF, submission for approval in
Japan, acceptance of the submission by PMDA, and ongoing enrollment in
the CardiAMP HF II trial.
Helix(TM) Biotherapeutic Delivery System
-- In August, FDA accepted our minutes from our Q2 Pre Submission Meeting
for De Novo approval of the Helix transendocardial delivery catheter as
formal minutes without changes.
-- In September, based on these minutes, we submitted our revised
Pre-Submission to FDA, which was accepted by FDA in October. The FDA aims
to issue written feedback or hold a meeting within 70 calendar days. We
expect to hear from the FDA on this Pre-Submission in the next six weeks.
-- With FDA alignment on the De Novo approval pathway for Helix, we expect
to complete the De Novo submission in the first quarter of 2027 with
approval in mid-2027 if FDA meets its official target goal of 150 review
days under Medical Device User Fee Amendments (MDUFA) guidelines.
-- In addition to its role for our own therapeutic development activities,
the investigational Helix system has potential to become the leading
development platform for biologic therapies to treat heart disease, as it
provides efficient delivery and control for these investigational agents
to the heart. Helix performance for all developers is expected to be
further enhanced by our Heart3D fusion imaging platform.
Heart3D(TM) Fusion Imaging
-- The investigational Heart3D system enhances real time two-dimensional
X-ray imaging by fusing pre-procedure three-dimensional anatomical heart
models created from high-quality MRI and CT images for the interventional
cardiologist with a focus on cardiac biotherapeutic interventions and
biopsies. With Helix, it enables an elegant approach to cell, gene, and
protein-based therapies for cardiac indications.
-- We are working closely with our development and commercial partner,
CART-Tech, to perform a number of studies with CardiAMP Cell Therapy in
addition to gene therapy partners in parallel to advancing this platform
into the clinic in 2027.
Third Quarter 2026 Financial Results:
-- Net cash used in operations for the three months ended September 2026 was
$1.7 million, comparable to the $1.7 million for the three months ended
September 2025, and increased to $5.1 million for the nine months ended
September 2026, as compared to $4.9 million for the nine months ended
September 2025, primarily due to the timing of supplier payments.
-- The Company ended the quarter with cash and cash equivalents totaling
$2.2 million, providing anticipated runway into 2027.
-- Research and development expenses increased to $1.2 million for the three
months ended September 2026 as compared to $936,000 in the three months
ended September 2025, primarily due to a bonus accrual at a higher level,
coupled with increased expenses from regulatory activities to advance
CardiAMP in Japan and enrollment in the CardiAMP HF II Trial Research and
development expenses decreased to $3.4 million in the nine months ended
September 30, 2026 as compared to $3.8 million in the nine months ended
September 30, 2025 primarily due to closeout of the CardiAMP Heart
Failure Trial, partially offset by early enrollment in the CardiAMP Heart
Failure II Trial and regulatory activities to advance CardiAMP in Japan.
-- Selling, general and administrative expenses increased to $600,000 in the
three months ended September 30, 2026 as compared to $552,000 in the
three months ended September 30, 2025. Selling, general and
administrative expenses remained consistent at $2.4 million in the nine
months ended September 30, 2026 and in the nine months ended September
30, 2025.
-- Our net loss was $1.9 million for the three months ended September 2026
compared to $1.5 million for the three months ended September 2025. Our
net loss decreased to $5.8 million for the nine months ended September
2026 compared to $6.2 million for the nine months ended September 2025,
primarily due to lower research and development expenses.
ANTICIPATED UPCOMING MILESTONES AND EVENTS:
-- CardiAMP Cell Therapy Shonin Submission to Japan PMDA Q4 2026 / Q1 2027
-- CardiAMP HF Trial Peer Reviewed Manuscript Q1 2027
-- Helix transendocardial delivery system FDA De Novo Pre-submission Meeting
Q4 2026
-- Heart3D FDA Submission Q1 2027
-- Gene therapy study with partner(s) using Helix and Heart3D Q1/2027
Conference call access:
Participants can register for the conference by navigating to https://dpregister.com/sreg/10213286/10535c5b644. 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=O8EiucRo.
A webcast replay of the call will be available approximately one hour after the end of the call at the following link: https://services.choruscall.com/ccforms/replay.html. A telephonic replay of the call will be available and may be accessed by calling 1-855-669-9658 (toll free domestic/Canada) and 1-412-317-0088 (international toll) by using access code 3063624.
About BioCardia(R)
BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP(R) autologous and CardiALLO(TM) allogeneic cell therapies are the Company's biotherapeutic platforms with three cardiac clinical stage product candidates in development. These therapies are enabled by its Helix(TM) biotherapeutic delivery and Morph(R) vascular navigation product platforms, and soon the Heart3D(TM) fusion imaging platform. BioCardia selectively partners on biotherapeutic delivery with peers developing important biologic therapies.
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.
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