BioCardia, Inc. - BCDA STOCK NEWS

BioCardia, Inc. (Nasdaq: BCDA) announced the issuance of two significant patents that enhance its capabilities in cellular therapies for cardiovascular diseases. The U.S. Patent Office granted Patent Number 11,716,859 for a 'Multi-Directional Steerable Catheter' which will expire in 2035, supporting advanced catheter navigation and performance. Additionally, the Indian Patent Office issued Patent Number 424579 for 'Steerable Endoluminal Devices,' which will expire in late 2031, reflecting the robust design of BioCardia’s products used in over 10,000 patient treatments. These patents are expected to strengthen BioCardia's market position and protect its innovative therapeutic approaches.

BioCardia, Inc. (Nasdaq: BCDA) announced its 2022 financial results, reporting revenues of $1.4 million, a rise from $1.0 million in 2021, driven by collaborations and performance obligations. R&D expenses increased to $8.8 million, while SG&A costs decreased to $4.4 million. The net loss narrowed to $11.9 million, down from $12.6 million in the previous year. Notably, BioCardia is advancing four clinical studies in novel cell therapies for heart failure and pulmonary conditions, with potential catalysts for growth in 2023. The company ended 2022 with $7.4 million in cash, providing operational runway through Q3 2023.

BioCardia, Inc. (NASDAQ: BCDA) announced it will report its financial results for the year ended December 31, 2022, during a conference call on March 29, 2023, at 4:30 PM ET. The call will include a corporate update followed by a Q&A session. Interested participants can register for the call through a provided link and will receive their dial-in number upon registration. The conference call will also be accessible via a live webcast. A replay of the call will be available shortly after, lasting until June 29, 2023. BioCardia focuses on developing biotherapeutics for cardiovascular and pulmonary diseases, leveraging two main platforms for its product candidates.

BioCardia (Nasdaq: BCDA) has presented new echocardiography data from the roll-in cohort of the Phase III CardiAMP® Cell Therapy Heart Failure Trial, revealing significant improvements in heart function over two years. The data, shared by Dr. Peter Johnston at the American College of Cardiology meeting, shows a more than doubling of heart segments functioning normally post-treatment. Left ventricular ejection fraction (LVEF) improved from 27% at baseline to 37% at two years. Notably, there were no serious adverse events, and two-year survival was 100%. The ongoing trial, which has FDA Breakthrough Device designation, aims to further evaluate the therapy's efficacy.

BioCardia, Inc. (Nasdaq: BCDA) and CellProthera have strengthened their partnership through an amendment to their Clinical Research Supply Agreement. This agreement allows CellProthera to utilize BioCardia's Helix™ delivery system for its Phase I/IIb EXCELLENT study of ProtheraCytes™, an autologous cell therapy addressing severe post-Acute Myocardial Infarction (AMI) cases. The collaboration aims to enhance patient outcomes and expedite commercialization efforts, with potential early access in 2024. BioCardia will receive a low single-digit royalty on future sales of ProtheraCytes if not partnered directly.

BioCardia (Nasdaq: BCDA) has made significant advancements in its clinical-stage therapies, particularly with its lead product, CardiAMP, which targets ischemic heart failure. The ongoing Phase III trial is showing promising results, with a mortality rate below 3% across multiple phases. The FDA has granted Breakthrough Device Designation for CardiAMP. In addition, BioCardia has secured IND approvals for two allogeneic therapies. The company has successfully navigated regulatory milestones, including a $3.6 million financing that enhances its future prospects.

BioCardia, Inc. (Nasdaq: BCDA) has announced a private placement agreement to sell 2,122,017 shares of its common stock to institutional investors at $1.68 per share, yielding expected gross proceeds of approximately $3.6 million. The closing is anticipated on December 16, 2022, subject to customary conditions. Proceeds will support general corporate purposes, including research and development of cell therapies. The shares are unregistered under the Securities Act and will require a registration statement for resale.

BioCardia has received FDA approval for a Phase I/II clinical trial of its NK1R+ allogeneic MSC therapy aimed at treating ischemic heart failure. This marks the second clinical trial approval for the company's NK1R+ MSC platform this year. The therapy complements the ongoing Phase III CardiAMP trial, which studies autologous cell therapy. The NK1R+ therapy is designed for patients ineligible for the CardiAMP trial and may offer a synergistic approach to treatment, addressing the needs of a broader patient population.

BioCardia, Inc. (BCDA) reported its Q3 financial results for 2022, revealing revenue growth to approximately $1.2 million year-to-date. The company's lead therapy, CardiAMP, is progressing in pivotal trials for ischemic heart failure and chronic myocardial ischemia, with positive DSMB support for study continuation. New IND applications for allogeneic cell therapies are anticipated to receive FDA approval soon, further supporting growth. Despite a net loss of approximately $8.9 million, the modest burn rate and funding initiatives aim to strengthen the balance sheet.