Full Press Release Details
SUNNYVALE, Calif., Nov. 12, 2025 (GLOBE NEWSWIRE) --BioCardia, Inc.[Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the third quarter of 2025 and filed its quarterly report on Form 10-Q for the three and nine months ended September 30, 2025 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.
“This quarter’s $6 million financing is actively supporting approvability discussions of CardiAMP cell therapy for patients suffering from heart failure, submission for approval of our Helix Transendocardial Delivery Catheter via DeNovo 510(k) to enable the field of local biologic therapy to the heart, and our actively enrolling in our CardiAMP HF II phase 3 confirmatory trial,” said BioCardia CEO Peter Altman, Ph.D. “These next two quarters promise to be truly transformative for our business because of these and other activities underway.”Recent Business Highlights
CardiAMP®autologous cell therapy in ischemic heart failure of reduced ejection fraction (HFrEF), BCDA-01
CardiAMP®autologous cell therapy in chronic myocardial ischemia with refractory angina, BCDA-02
CardiALLO™ allogeneic cell therapy in Ischemic Heart Failure, BCDA-03
Biotherapeutic Delivery
Third Quarter 2025 Financial Results:
ANTICIPATED UPCOMING MILESTONES AND EVENTS:
BCDA-01 CardiAMP Autologous Cell Therapy in Heart Failure (HF)
BCDA-02 CardiAMP Autologous Cell Therapy in Chronic Myocardial Ischemia
BCDA-03 CardiALLO Allogeneic MSC Cell Therapy in Heart Failure
Helix Biotherapeutic Delivery System
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 with three cardiac clinical stage product candidates in development. These therapies are enabled by its Helix™biotherapeutic delivery and Morph®vascular navigation platforms. 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 tohttps://dpregister.com/sreg/10204565/1005a9b26d8. 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=v3qWCosD.
A webcast replay of the call will be available approximately one hour after the end of the call at the above links. To access the replay internationally, please use the linkhttps://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) or 1-412-317-0088 (international toll) by using access code 4273038.
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 PMDA, product clearances, the efficacy and safety of our products and therapies, 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, future prospects, regulatory timelines, 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 the 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 26, 2025, under the caption titled “Risk Factors BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
| BIOCARDIA, INC. | ||||||||||||||
| Consolidated Statements of Operations | ||||||||||||||
| (Unaudited In thousands, except share and per share amounts) | ||||||||||||||
| Three Months endedSeptember 30, | Nine Months endedSeptember 30, | |||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||
| Revenue: | ||||||||||||||
| Collaboration agreement revenue | $ | — | $ | — | $ | — | $ | 58 | ||||||
| Costs and expenses: | ||||||||||||||
| Research and development | 936 | 931 | 3,834 | 2,972 | ||||||||||
| Selling, general and administrative | 552 | 825 | 2,431 | 2,766 | ||||||||||
| Total costs and expenses | 1,488 | 1,756 | 6,265 | 5,738 | ||||||||||
| Operating loss | (1,488 | ) | (1,756 | ) | (6,265 | ) | (5,680 | ) | ||||||
| Other income (expense): | ||||||||||||||
| Total other income, net | 5 | 19 | 21 | 30 | ||||||||||
| Net loss | $ | (1,483 | ) | $ | (1,737 | ) | $ | (6,244 | ) | $ | (5,650 | ) | ||
| Net loss per share, basic and diluted | $ | (0.24 | ) | $ | (0.61 | ) | $ | (1.17 | ) | $ | (2.65 | ) | ||
| Weighted-average shares used in computing | ||||||||||||||
| net loss per share, basic and diluted | 6,277,848 | 2,827,492 | 5,330,465 | 2,129,258 |
| BioCardia, Inc. | |||||
| Selected Balance Sheet Data | |||||
| (amounts in thousands) | |||||
| September 30, | December 31, | ||||
| 2025(1) | 2024(1) | ||||
| Assets: | |||||
| Cash and cash equivalents | $ | 5,287 | $ | 2,371 | |
| Other current assets | 78 | 251 | |||
| Property, plant and equipment and other noncurrent assets | 783 | 1,102 | |||
| Total assets | $ | 6,148 | $ | 3,724 | |
| Liabilities and Stockholders’ Equity | |||||
| Current liabilities | $ | 3,310 | $ | 2,321 | |
| Operating lease liability - noncurrent | 211 | 566 | |||
| Total stockholders’ equity | 2,627 | 837 | |||
| Total liabilities and stockholders’ equity | $ | 6,148 | $ | 3,724 | |
| (1) September 30, 2025 amounts are unaudited. December 31, 2024 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, 2024, filed with the U.S. Securities and Exchange Commission on March 26, 2025. |