On August 9, 2018 BioCardia, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, reported financial results and business highlights for the second quarter 2018 and filed its quarterly report on Form 10-Q for the three and six months ended June 30, 2018 with the Securities and Exchange Commission (Press release, Biocardia, AUG 9, 2018, View Source [SID1234528586]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Second Quarter 2018 Financial Results:
Revenues increased to $239,000 for the second quarter of 2018 compared to $112,000 for the second quarter of 2017.
Net loss was $3.2 million for the second quarter of 2018, compared to $2.9 million for the second quarter of 2017.
Research and development expenses increased to $2.0 million in the second quarter of 2018, compared to $1.3 million in the second quarter of 2017, primarily due to expenses associated with the pivotal CardiAMP Heart Failure Trial and development of the Company’s second cell therapy candidate, the CardiALLO Cell Therapy System.
Selling, general and administrative expenses decreased to $1.3 million in the second quarter of 2018, compared to $1.6 million in the second quarter of 2017, primarily due to lower stock compensation expense.
Net cash used in operations in the second quarter of 2018 was $2.8 million, as compared to $2.1 million in the second quarter of 2017.
2018 Corporate Highlights:
Enrollment in the pivotal CardiAMP Heart Failure Trial has expanded to 17 world class centers in the United States as detailed on ClinicalTrials.Gov.
Two abstracts have been accepted for presentation at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Diego, one of the world’s largest and most important educational meeting specializing in interventional cardiovascular medicine. Both presentations are scheduled for September 24, 2018:
"The CardiAMP Heart Failure Study: First Results from Unblinded Roll-In Phase", to be presented at 9:06 am PDT.
"Performance of Helix Transendocardial Biotherapeutic Delivery System after 300 Cases", to be presented at 9:18 am PDT.
The U.S. Food and Drug Administration approved a second pivotal Investigational Device Exemption trial for the CardiAMP Cell Therapy System for the treatment of chronic myocardial ischemia with refractory angina, the "CardiAMP Chronic Myocardial Ischemia Trial". The Centers for Medicare and Medicaid Services (CMS) has approved this trial for national reimbursement coverage.
The Company received a new US patent related to its CardiAMP cell potency assay, providing further protection to its autologous cell therapy programs in both heart failure and chronic myocardial ischemia indications.
Anticipated Upcoming Milestones:
12-month data from the CardiAMP Heart Failure Trial 10-patient roll-in cohort in the fourth quarter 2018.
Filing of the Investigational New Drug (IND) for the CardiALLO Cell Therapy System, an investigational allogenic culture expanded "off the shelf" mesenchymal cell therapy for the treatment of ischemic heart failure, in the fourth quarter 2018.
Filing for FDA approval of an advanced bidirectional steerable guide system in the fourth quarter 2018.
Dosing of the first patient in the pivotal CardiAMP Chronic Myocardial Ischemia Trial in the first quarter 2019.
Completion of enrollment in the pivotal CardiAMP Heart Failure Trial in the third quarter 2019.