Biocardia Inc Stock Price, News & Analysis

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.

BioCardia, Inc. [Nasdaq: BCDA] will present at Cantor Fitzgerald’s Cell and Genetic Medicines Conference on September 15, 2022, held at the Lotte New York Palace Hotel, NYC. The conference will focus on advancements in cell therapies, including CRISPR technologies and regulatory pathways. CEO Dr. Peter Altman will join a panel discussing the significance of partnerships with large-cap pharma. Attendance is in person only, with no live broadcast. BioCardia specializes in cell-based therapeutics for cardiovascular diseases, with its CardiAMP therapies receiving FDA Breakthrough designation and CMS reimbursement.

BioCardia (Nasdaq: BCDA) announced favorable results from its Phase III CardiAMP® Cell Therapy Heart Failure Trial. The independent Data Safety Monitoring Board (DSMB) reported no significant safety concerns and recommended continuing the study. The trial includes data from 101 patients past the 12-month primary endpoint, showing a higher one-year survival rate compared to similar trials. An adaptive statistical analysis plan is suggested for future evaluations. The study aims to enroll 260 patients across 40 U.S. and Canada centers, with results pending formal unblinding and analysis.

BioCardia (Nasdaq: BCDA) announced a collaboration with BlueRock Therapeutics to deliver cell therapy for heart failure. This agreement includes a substantial up-front payment, contributing to BioCardia's efforts to enhance cardiovascular treatments. CEO Peter Altman emphasized the significant potential benefits for both BlueRock's programs and patients with cardiovascular disease. The partnership offers an option for a non-exclusive, worldwide license for specific cardiac indications. However, forward-looking statements indicate that actual results may vary and are subject to risks disclosed in BioCardia's SEC filings.

BioCardia, Inc. (Nasdaq: BCDA) reports Q2 2022 financial results, with revenues reaching $1.0 million, up from $0.1 million in Q2 2021, largely due to collaboration revenue. The net loss decreased to $2.5 million from $3.5 million year-over-year. The company is advancing its CardiAMP cell therapy for ischemic heart disease and lung inflammation in pivotal clinical trials, with key milestones expected, including a data review on August 30, 2022. BioCardia is optimistic about regulatory discussions in Japan and securing FDA IND acceptance for its allogeneic cell therapy for ARDS.