Biocardia Inc Stock Price, News & Analysis

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.

BioCardia, Inc. (NASDAQ:BCDA) will report its financial results for the three and nine months ended September 30, 2022, on November 9, 2022. The announcement includes a corporate update during a conference call scheduled for 4:30 PM ET. Interested parties can register for the call or join via phone, with a replay available afterward. BioCardia focuses on developing cellular therapies for cardiovascular and pulmonary conditions, utilizing two biotherapeutic platforms that aim to benefit millions of patients.

BioCardia, Inc. (Nasdaq: BCDA) announces encouraging results from its CardiAMP Cell Therapy pivotal trial for heart failure, presented at the Heart Failure Society of America meeting. In a roll-in cohort, patients demonstrated a remarkable 100% two-year survival rate, surpassing existing therapies which reported 79.9% survival. Additionally, significant improvements were noted in functional capacity, with a median walking distance increase from baseline. No serious adverse events occurred, indicating a favorable safety profile. A conference call is scheduled for October 5, 2022, to discuss the results and next steps.

BioCardia Inc. (Nasdaq: BCDA) announced the presentation of new data from its CardiAMP® Cell Therapy for Heart Failure pivotal trial at the Heart Failure Society of America Annual Meeting on October 1, 2022. The data will reveal efficacy outcomes at two years for the roll-in cohort of Phase III trial NCT02438306. A follow-up conference call on October 3, 2022, will discuss the trial status and the implementation of an adaptive statistical analysis plan suggested by the Data Safety Monitoring Board.

BioCardia, Inc. (NASDAQ: BCDA) announced its participation in the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, 2022, at the Lotte New York Palace Hotel. Dr. Peter Altman, CEO, will present an overview of the company's business.
The firm focuses on developing cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, boasting two key products: CardiAMP® autologous and NK1R+ allogeneic cell therapies, with significant FDA designations and CMS reimbursements.