STOCK TITAN

BioCardia (BCDA) trims Q2 2026 loss amid supportive FDA and PMDA feedback

(Moderate)
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

BioCardia, Inc. reported second quarter 2026 results highlighting supportive regulatory feedback and a narrower loss. Japan’s PMDA indicated it supports a regulatory submission for CardiAMP Cell Therapy for ischemic heart failure, the FDA indicated the CardiAMP HF II trial may be sufficient for U.S. approval, and the FDA also said DeNovo approval of the Helix transendocardial delivery catheter is possible. The company is preparing a PMDA submission for the fourth quarter, continues enrolling the CardiAMP HF II trial, and is awaiting FDA minutes on the Helix DeNovo pre-submission.

For the quarter ended June 30, 2026, net loss was $1.6 million compared with $2.0 million a year earlier, with net loss per share of $0.13 versus $0.40. Research and development expenses were $0.9 million and selling, general and administrative expenses were $0.7 million. For the first six months of 2026, net loss was $3.9 million versus $4.8 million. As of June 30, 2026, cash and cash equivalents were $4.1 million and total stockholders’ equity was $2.7 million.

Positive

  • Net loss narrowed significantly, improving from $2.0 million to $1.6 million year over year for Q2 2026, and from $4.8 million to $3.9 million for the first six months.
  • Balance sheet strengthened with cash and cash equivalents rising to $4.1 million from $2.5 million and total stockholders’ equity increasing to $2.7 million from $0.9 million.
  • Regulatory momentum with Japan’s PMDA supporting CardiAMP submission, FDA indicating the CardiAMP HF II trial may be sufficient for approval, and stating DeNovo approval of Helix is possible.

Negative

  • None.

Filing Explained

The reported per-share loss of $0.13 used 12,093,268 weighted-average shares, versus 5,059,736 a year earlier. The filing labels these as shares used to compute net loss per share, not shares issued or outstanding, so this adds share-count context without establishing a current ownership change.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Q2 2026 Net Loss $1,613 thousand Three months ended June 30, 2026
Q2 2025 Net Loss $2,049 thousand Three months ended June 30, 2025
Q2 2026 Net Loss Per Share $0.13 Basic and diluted net loss per share for Q2 2026
Cash and Cash Equivalents $4,117 thousand As of June 30, 2026
Total Stockholders’ Equity $2,700 thousand As of June 30, 2026
Research and Development Expense $893 thousand Three months ended June 30, 2026
Total Costs and Expenses $1,623 thousand Three months ended June 30, 2026
Weighted-Average Shares 12,093,268 Weighted-average shares used in computing Q2 2026 net loss per share
DeNovo approval regulatory
"the FDA has said DeNovo approval of Helix is possible"
CardiAMP Cell Therapy medical
"supports regulatory submission for approval of our CardiAMP Cell Therapy for Ischemic Heart Failure"
A cardiamp cell therapy is a medical treatment that uses living cells—typically taken from a patient’s own bone marrow or blood—to help repair damaged heart muscle and improve blood flow. Think of it as using a repair crew made from a homeowner’s own materials to patch a leaky roof; for investors, it matters because such therapies can offer new alternatives to surgery or drugs, carry high development and regulatory costs, and can meaningfully affect market demand and reimbursement if proven effective.
Pharmaceutical and Medical Device Agency (PMDA) regulatory
"Japan’s Pharmaceutical and Medical Device Agency (PMDA) has said it supports regulatory submission"
Pharmaceutical and Medical Device Agency (PMDA) is Japan’s national regulator that reviews and approves medicines, medical devices and related safety measures, assesses clinical data, and oversees post‑market surveillance and inspections. For investors, PMDA actions—approvals, rejections, label changes or safety warnings—directly affect a product’s ability to reach and stay on the market, the timing of revenue, and the regulatory risk profile of companies, acting like a gatekeeper for commercial access.
software as a medical device 510(k) submission regulatory
"towards regulatory approval via the software as a medical device 510(k) submission route"
transendocardial delivery catheter medical
"approval of the Helix transendocardial delivery catheter held with FDA in May"
A transendocardial delivery catheter is a thin, flexible medical tube designed to reach the inner surface of the heart and inject therapies directly into the heart muscle, much like using a precise hose to water the roots of a plant rather than sprinkling the surface. For investors, it matters because this specialized delivery method can improve treatment effectiveness, affect procedure complexity, regulatory approval, and reimbursement, and therefore influence the commercial potential and clinical adoption of heart-targeted therapies.
autologous cell therapy medical
"CardiAMP autologous cell therapy in chronic myocardial ischemic with refractory angina"
Autologous cell therapy uses a patient’s own cells, taken out, sometimes modified or multiplied, and then returned to the same person to treat disease or repair tissue. It matters to investors because using a person’s own cells can lower the chance of immune rejection and change the regulatory and clinical risk profile, but it also creates high, customized manufacturing and delivery costs and limits how easily the therapy can be scaled — like bespoke tailoring versus off‑the‑rack clothing.
Q2 2026 Net Loss $1,613 thousand Improved from $2,049 thousand in Q2 2025
Six-Month 2026 Net Loss $3,872 thousand Improved from $4,761 thousand in 2025 period
Cash and Cash Equivalents $4,117 thousand Increased from $2,496 thousand at December 31, 2025

FAQ

How did BioCardia (BCDA) perform financially in Q2 2026?

BioCardia reported a Q2 2026 net loss of $1.6 million, improving from $2.0 million a year earlier. Net loss per share was $0.13 versus $0.40, reflecting higher weighted-average shares and reduced operating expenses.

What are the key regulatory updates BioCardia (BCDA) reported for Q2 2026?

Japan’s PMDA indicated it supports CardiAMP Cell Therapy submission for ischemic heart failure, and the FDA indicated the CardiAMP HF II trial may be sufficient for U.S. approval and that DeNovo approval of Helix is possible.

What was BioCardia’s cash position as of June 30, 2026?

As of June 30, 2026, BioCardia had cash and cash equivalents of $4.1 million, up from $2.5 million at December 31, 2025. Total assets were $4.8 million and stockholders’ equity was $2.7 million.

How did BioCardia’s expenses change in Q2 2026 compared to Q2 2025?

In Q2 2026, research and development expenses were $0.9 million versus $1.4 million, while selling, general and administrative expenses were $0.7 million versus $0.7 million. Total costs and expenses decreased to $1.6 million from $2.1 million.

What were BioCardia’s results for the first six months of 2026?

For the six months ended June 30, 2026, BioCardia reported a net loss of $3.9 million compared with $4.8 million for the same period in 2025. Net loss per share was $0.34 versus $0.98 as weighted-average shares increased.

What upcoming milestones did BioCardia (BCDA) highlight?

BioCardia is preparing a CardiAMP PMDA submission for the fourth quarter, actively enrolling the CardiAMP HF II trial, and awaiting FDA minutes on the Helix DeNovo pre-submission, while pursuing business development around its cell therapies and delivery technologies.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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false 0000925741 0000925741 2026-08-12 2026-08-12
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 8-K
 
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported): August 12, 2026
 
BIOCARDIA, INC.
(Exact name of registrant as specified in its charter)
 
Delaware
 
001-38999
 
23-2753988
(State or other jurisdiction
of incorporation)
 
(Commission
File Number)
 
(IRS Employer
Identification No.)
 
320 Soquel Way
SunnyvaleCalifornia 94085
 
(Address of principal executive offices and zip code)
 
 
Registrants telephone number, including area code: (650226-0120
 

 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, par value $0.001
BCDA
The Nasdaq Capital Market
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter)  
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
 

 
Item 2.02.         Results of Operations and Financial Condition.
 
On August 12, 2026, BioCardia, Inc. issued a press release announcing its financial results for the quarter ended June 30, 2026. A copy of the press release is furnished as Exhibit 99.1 to this report.
 
The information in this Item 2.02, including the Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of such section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
 
Item 9.01   Financial Statements and Exhibits.
 
(d) Exhibits
 
Exhibit No.
 
Description
99.1
104
 
BioCardia, Inc. press release dated August 12, 2026
Cover Page Interactive Data File (embedded within the Inline XBRL document)

 
SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
BIOCARDIA, INC.
 
 
 
/s/ Peter Altman, Ph.D.
 
Peter Altman, Ph.D.
 
President and Chief Executive Officer
 
 
 
Date: August 12, 2026
 
 
 

Exhibit 99.1

 

BioCardia Reports Second Quarter 2026 Business Highlights and Financial Results

 

Sunnyvale, Calif. – August 12, 2026 - 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 second quarter 2026 and filed its quarterly report on Form 10-Q for the three and six months ended June 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.

 

“This second quarter, BioCardia had three important positive meetings with regulatory agencies in Japan and the United States,” said Peter Altman, PhD, Chief Executive Officer of BioCardia. “Japan’s Pharmaceutical and Medical Device Agency (PMDA) has said it supports regulatory submission for approval of our CardiAMP Cell Therapy for Ischemic Heart Failure, the U.S. Food and Drug Administration (FDA) has said the CardiAMP HF II trial may be sufficient for approval in the United States, and the FDA has said DeNovo approval of Helix is possible.”

 

Dr. Altman continued, “We are preparing the CardiAMP cell therapy PMDA submission for the fourth quarter, actively enrolling in the CardiAMP HF II trial, and awaiting FDA minutes on the DeNovo Pre-Submission for approval of the Helix transendocardial delivery catheter held with FDA in May. We are engaged in business development around our cell therapies and separately our experience and technologies for delivery of cardiac biologics which our therapies utilize. We are proud of our demonstrated efficient use of capital while executing on significant goals and expect success in these activities to deliver meaningful benefits for patients and stockholders.”

 

Recent Business Highlights

 

 

CardiAMP® autologous cell therapy in ischemic heart failure of reduced ejection fraction (BCDA-01)

 

 

In May, we announced the Japan’s Pharmaceutical and Medical Device Agency (PMDA) Consultation Record of Advice supports Shonin pre-market regulatory submission for approval based on the three completed clinical trials. PMDA’s Consultation Record confirms alignment on remaining questions to address before, and as part of the submission, for regulatory approval for ischemic HFrEF patients. PMDA noted that the positive outcomes seen in the trial were credible.

 

 

PMDA requested BioCardia demonstrate that enrolled patients were on guideline-directed medical therapy (GDMT) and not eligible for revascularization procedures, required per CardiAMP HF protocol, and provide additional details for each incidence of all-cause death, heart transplantation or left ventricular assist device implantation. PMDA also provided guidelines for developing the post marketing study. BioCardia believes these requests will be addressed to PMDA’s satisfaction and the post marketing study to be developed together with PMDA and Japanese medical societies will be straightforward.

 

 

In June, we announced receipt of FDA minutes from our Q-Sub Meeting with FDA Center for Biologics Evaluation and Research (CBER). The meeting minutes from FDA confirm that the ongoing CardiAMP Heart Failure II Trial may support Premarket Approval (PMA) for market clearance.

 


 

 

BioCardia is preparing for regulatory submission in Japan in Q4 2026. We are working to complete the electronic trial master file, conduct 3rd party Japanese good clinical practice audits to PMDA standards, and structure clinical research data in accordance with CDISC Standards, which support data consistency, traceability, and regulatory compliance. We are reviewing extensive product documentation. We expect to soon engage a Designated Marketing Authorization Holder, or DMAH, as the local regulatory representative to enable BioCardia sales of CardiAMP Cell Therapy in Japan.

 

 

BioCardia continues to actively enroll in the CardiAMP HF II trial. Four clinical sites have enrolled in the study and are actively recruiting patients. Three additional patients are expected to qualify for the study this month, and two are scheduled for their procedures this month.

 

CardiAMP autologous cell therapy in chronic myocardial ischemic with refractory angina (BCDA-02)

 

 

In May, primary results of this cohort were presented at Euro PCR, a world-leading course in interventional cardiovascular medicine. Results presented showed that the minimally invasive CardiAMP Cell Therapy procedure was well-tolerated with no treatment emergent major adverse cardiac events. Patients demonstrated positive clinical outcomes including increased exercise tolerance and reduced frequency of angina episodes with the autologous cell therapy up through 2 years follow-up. Prior to treatment, all patients were on GDMT and had received all available percutaneous and/or surgical options as appropriate for their medical condition. Patients experienced increased exercise tolerance, improving by an average of 179 seconds, which persisted for the two-year study follow-up. Angina episodes were reduced by an average of 82% by six-months after treatment.

 

Helix™ Biotherapeutic Delivery System

 

 

In May, BioCardia had a De Novo Pre-Submission meeting with FDA on approvability of the Helix transendocardial delivery catheter. As is customary, BioCardia provided draft minutes to FDA on May 12th with expectation that formal revised minutes from FDA or notification that the minutes are accepted and final would be provided on or before June 12th. FDA has advised us that we would receive these minutes soon and we anticipate submitting the follow-on pre-submission incorporating agency advice which could enable Helix approval via the DeNovo pathway.

 

Heart3D™ Fusion Imaging

 

In April, the Company announced the allowance of Japanese Patent, “Target Site Selection, Entry, and Update with Automatic Remote Image Annotation.” This patent adds further protection to BioCardia’s proprietary Heart3D™ Fusion Imaging (Heart3D) software intended for treatment planning and real-time navigation during CardiAMP Cell Therapy procedures. Heart3D is being advanced towards regulatory approval via the software as a medical device 510(k) submission route. It has been in discussions with many developers of gene and cell-based therapies on its potential to enhance others development efforts.

 


 

Second Quarter 2026 Financial Results:

 

 

>

Net cash used in operations for the three months ended June 2026 increased to $1.7 million, as compared to $1.6 million for the three months ended June 2025, and increased to $3.4 million for the six months ended June 2026, as compared to $3.3 million for the six months ended June 2025, primarily due to the timing of supplier payments.

 

 

>

During the second quarter, BioCardia raised net proceeds of approximately $4.9 million under our “At the Market” facility.

 

 

>

The Company ended the quarter with cash and cash equivalents totaling $4.1 million, providing anticipated runway into 2027.

 

 

>

Research and development expenses decreased to $0.9 million for the three months ended June 2026 from $1.4 million for the three months ended June 2025 and decreased to $2.1 million for the six months ended June 2026 from $2.9 million for the six months ended June 2025, primarily due to close out of the CardiAMP HF Trial, partially offset by early enrollment in the CardiAMP HF II Trial and regulatory activities to advance CardiAMP in Japan.

 

 

>

Selling, general and administrative expenses remained consistent at $0.7 million for both the three months ended June 2026 and June 2025, and decreased to $1.8 million for the six months ended June 2026 compared to $1.9 million in the six months ended June 2025.

 

 

>

Our net loss decreased to $1.6 million for the three months ended June 2026 compared to $2.0 million for the three months ended June 2025, and to $3.9 million for the six months ended June 2026 compared to $4.8 million for the six months ended June 2025, primarily due to lower research and development expenses.

 

 

ANTICIPATED UPCOMING MILESTONES AND EVENTS:

 

 

Shonin Submission of CardiAMP Cell Therapy to Japan PMDA (Q4 2026)

 

 

Continued CardiAMP Cell Therapy development in the USA with FDA engagement

 

 

Strategic partnership / licensing progress in Helix/Heart3D for cell, gene, and protein delivery to the heart

 

 

Strategic partnerships / licensing around our clinical allogeneic MSC platform

 


 

Conference call access:

 

Participants can register for the conference by navigating to https://dpregister.com/sreg/10211154/104a4f51d2e. 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=ufQzaenK.

 

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®

 

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® autologous and CardiALLOTM 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® 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.

 

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 sufficiency of data from our clinical trials, filings and communications with the FDA and Japan’s Pharmaceutical and Medical Device Agency, product clearances, the efficacy and safety of our products and therapies, preliminary conclusions about new data, 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 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 24, 2026, 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.

Condensed Consolidated Statements of Operations 
(Unaudited in thousands, except share and per share amounts)

 

Three Months ended

June 30,

Six Months ended 
June 30,

2026

2025

2026

2025

Costs and expenses:

Research and development

$

893

$

1,368

$

2,128

$

2,898

Selling, general and administrative

730

683

1,761

1,879

Total costs and expenses

1,623

2,051

3,889

4,777

Operating loss

(1,623

)

(2,051

)

(3,889

)

(4,777

)

Other income (expense):

Total other income, net

10

2

17

16

Net loss

$

(1,613

)

$

(2,049

)

$

(3,872

)

$

(4,761

)

Net loss per share, basic and diluted

$

(0.13

)

$

(0.40

)

$

(0.34

)

$

(0.98

)

Weighted-average shares used in computing net loss per share, basic and diluted

12,093,268

5,059,736

11,456,382

4,848,922

 


BioCardia, Inc.

Selected Balance Sheet Data

(amounts in thousands)

 

June 30,

December 31,

2026 (1)

2025 (1)

Assets:

Cash and cash equivalents

$

4,117

$

2,496

Other current assets

181

236

Property, plant and equipment and other noncurrent assets

457

681

Total assets

$

4,755

$

3,413

Liabilities and Stockholders’ Equity

Current liabilities

$

2,055

$

2,432

Operating lease liability - noncurrent

86

Total stockholders’ equity

2,700

895

Total liabilities and stockholders’ equity

$

4,755

$

3,413

 

(1)  June 30, 2026 amounts are unaudited. December 31, 2025 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, 2025, filed with the U.S. Securities and Exchange Commission on March 24, 2026.

 

 

###

 

Media Contact: 
Miranda Peto, Investor Relations
Email: mpeto@BioCardia.com 
Phone: 650-226-0120

 

Investor Contact: 
David McClung, Chief Financial Officer
Email: investors@BioCardia.com
Phone: 650-226-0120

 

 

Filing Exhibits & Attachments

5 documents