BioCardia, Inc. SEC Filings

GILLIS EDWARD M reported acquisition or exercise transactions in this Form 4 filing.

BioCardia, Inc. reported that Senior Vice President, Devices, Edward M. Gillis received a grant of 39,521 shares of common stock on June 29, 2026. These were issued as restricted stock units awarded as compensation in lieu of cash, at a reference value of $1.20 per share. All of the RSUs vested on June 29, 2026, and his directly held common stock position increased to 71,395 shares after the grant.

BioCardia, Inc. director Simon H. Stertzer reported open‑market purchases of the company’s common stock. On June 22, he bought 70,200 shares at a reported weighted average price of $0.92 per share, in multiple trades ranging from $0.90 to $0.97 per share.

On June 23, he bought an additional 39,000 shares at a reported weighted average price of $1.00 per share, in trades ranging from $1.00 to $1.01 per share. After these transactions, his direct holdings rose to 166,338 shares, and the filing also lists several indirect holdings through family trusts and LLCs, including positions such as 591,054 shares held by Stertzer Holdings LLC.

BioCardia, Inc. President and CEO Peter Altman reported open-market purchases of the company’s Common Stock. On June 17, 2026, he bought 1,500 shares at a weighted average price of $0.85 per share. On June 18, 2026, he bought an additional 800 shares at a weighted average price of $0.96 per share. Following these transactions, Altman directly owns 300,566 shares of BioCardia Common Stock.

BioCardia, Inc. provided shareholders with a strategic update outlining its 2026 priorities and regulatory plans. The company is preparing a CardiAMP Cell Therapy approval submission to Japan’s PMDA for ischemic heart failure, initially targeting about 20,000 patients out of an estimated 300,000 in Japan.

Management highlights Japan’s role as a reference country and MDSAP member, which may streamline registrations in other regions if approval is obtained and manufacturing passes a single audit. BioCardia is also enrolling the CardiAMP HF II confirmatory trial in the United States and expanding participating centers.

The letter emphasizes the Helix delivery and Heart3D imaging platforms as a “pipeline-in-a-product” for multiple cardiac gene and cell therapies, along with an off‑the‑shelf MSC platform supported by two FDA‑approved INDs. Recent financing is described as sufficient to advance the Japan submission, U.S. enrollment, and ongoing partnering discussions.

BioCardia, Inc. reported an update on its Nasdaq listing compliance. The company previously fell below the $2.5 million stockholders’ equity requirement under Nasdaq Listing Rule 5550(b)(1) but submitted a plan and received an extension from Nasdaq staff until October 7, 2026 to regain compliance.

Through its at-the-market equity program with H.C. Wainwright & Co., BioCardia sold 4,004,330 shares of common stock between April 1 and June 5, 2026 at an average price of about $1.27 per share, generating net proceeds of $4.9 million. The company believes these transactions have raised stockholders’ equity above $2.5 million as of this report, though Nasdaq will continue to monitor compliance and could delist the stock if a future periodic report does not show the required equity level.

BioCardia, Inc. President and CEO Peter Altman reported an open-market purchase of 5,000 shares of common stock at $0.85 per share. After this transaction, he directly owns 298,266 BioCardia common shares, indicating a modest increase in his personal equity stake in the company.

BioCardia, Inc. reported that it raised approximately $4.4 million through an at-the-market stock sale. The company sold 3,509,604 shares at an average price of $1.279 per share on June 5, 2026, under its at-the-market offering agreement with H.C. Wainwright & Co.

Management anticipates that net proceeds will extend BioCardia’s cash runway into the first quarter of 2027, beyond its planned Japan PMDA submission for CardiAMP Cell Therapy. The company also noted that no warrants were issued in this capital raise, and if currently outstanding warrants from prior financings are fully exercised for cash, the cash runway is expected to extend well beyond PMDA approval and into initial commercial sales.

BioCardia, Inc. announced that FDA Center for Biologics Evaluation and Research meeting minutes confirm the ongoing CardiAMP Heart Failure II Trial may be used to support a Premarket Approval (PMA) application for the CardiAMP Cell Therapy System in ischemic heart failure with reduced ejection fraction.

The company notes that FDA typically prefers two well-designed trials for large indications such as HFrEF, where there are potentially over one million U.S. patients who could benefit from CardiAMP Cell Therapy, so FDA’s acknowledgement of this single ongoing trial as potentially sufficient is an important regulatory step.

CardiAMP Cell Therapy has FDA Breakthrough designation and uses a patient’s own bone marrow cells delivered via a minimally invasive catheter procedure to improve microvascular function in myocardial tissue. Regulatory discussions in Japan suggest three completed heart failure trials may provide enough safety and efficacy evidence for approval there, while U.S. trials have received reimbursement from the Centers for Medicare and Medicaid Services.

BioCardia reported that Japan’s Pharmaceutical and Medical Device Agency (PMDA) issued a Consultation Record that supports submission for regulatory approval of its CardiAMP cell therapy for ischemic heart failure with reduced ejection fraction. The agency confirmed alignment on remaining questions and noted the trial’s positive outcomes were credible.

The company plans to submit in approximately seven months, with the regulatory submission anticipated in Q4 2026. BioCardia estimates that 20,000 of 300,000 ischemic heart failure patients in Japan could initially be eligible if approved. Prior trials showed the minimally invasive procedure was well tolerated, with average exercise tolerance improving 179 seconds and angina episodes reduced by 82%.