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BioCardia, Inc. (BCDA)

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  • BioCardia Reports Third Quarter 2020 Financial Results and Business Highlights
    GlobeNewswire

    BioCardia Reports Third Quarter 2020 Financial Results and Business Highlights

    SAN CARLOS, Calif., Nov. 10, 2020 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [NASDAQ: BCDA], a leader in the development of autologous and allogenic cell therapies, today reported financial results and business highlights for the third quarter of 2020 and filed its quarterly report on Form 10-Q for the three and nine months ended September 30, 2020 with the Securities and Exchange Commission on November 10, 2020. The Company is advancing its autologous and allogenic bone marrow-derived cell therapies for three cardiovascular indications and one respiratory indication.Third Quarter 2020 Business Highlights:Autologous Cell Therapies * BCDA-01: Patient enrollment in the Phase III pivotal trial of the investigational CardiAMP® cell therapy for the treatment of heart failure continued as centers slowly emerge from the challenges related to COVID-19. As of today, 81 patients have been randomized, four patients are being scheduled for treatment after passing screening with the cell potency assay, and nine additional patients have recently been consented and are actively being screened. Clinical sites remain engaged and momentum is resuming for these elective enrollment activities. Data transfer for the DSMB review scheduled for December 15th has been completed. The anticipated DSMB review in the fourth quarter of 2020, including the risk benefit analysis of 60 patients at their primary endpoint, appears to be on track. * BCDA-02: A second clinical application of CardiAMP cell therapy for the treatment of chronic myocardial ischemia is also advancing in an FDA-approved pivotal trial, which is also being reimbursed by the Centers for Medicaid and Medicare Services (CMS). The Company began the third quarter by activating this trial at the University of Florida as the first clinical site. Four additional sites are in active contracting and budget negotiations. Enrollment of the first patient in this trial in the fourth quarter of 2020 appears to be on track.  Allogenic Cell Therapies * BCDA:03: Development continued in the CardiALLO™ neurokinin-1 receptor positive (NK1R+) mesenchymal stem cell (MSC) program targeted to treat patients with heart failure who are ineligible for the Company’s autologous cell therapy due to their cell potency assay score. After responding to FDA comments on the Investigational New Drug Application in the second quarter of 2020, the FDA raised additional questions related to long-term preclinical follow-up results. Of note, it appears that all questions on the clinical protocol and the chemistry manufacturing and controls have now been addressed to the agency’s satisfaction. The preclinical studies requested by the FDA have been completed and the data reports provided to the agency. The conclusion from these studies is that, following myocardial infarction, intramyocardial injection of the Company’s NK1R+ MSCs did not result in any significant observed treatment-related serious adverse events. Further, the investigational cells showed signs of efficacy in an animal disease model, with improved cardiac wall motion, fractional shortening, and cardiac output in both the low dose and the high dose cohorts at both 30-day and 90-day follow-up. The Company appears to be on track for acceptance of this IND by the FDA in the fourth quarter of 2020. * BCDA-04: Pre-clinical work to pursue a program with the NK1R+ MSC to treat acute respiratory distress developing from COVID-19 was also completed successfully with no significant observed product safety issues. The team is currently developing the IND submission which will rely significantly on the submission for BCDA-03. Acceptance of this IND by the FDA in the fourth quarter of 2020 remains possible if the Company completes its IND submission by the end of November 2020.Corporate Developments * BioCardia was awarded U.S. Patent No: 10,780,248 for a “Radial and Transendocardial Delivery Catheter” that further protects the Helix™ Biotherapeutic Delivery System and enhances its cell therapy delivery capabilities. This patent provides additional broad protection for the Helix system, as well as for the three therapeutic programs that it enables. “We are reaching critical milestones in our cardiovascular and respiratory cell therapy development programs at a time when patients are increasingly presenting with heart damage due to COVID-19,” said BioCardia CEO Peter Altman, PhD. “We believe that the clinical data supports patient benefit through paracrine mechanisms, which differs from those attempting to transform cells into new heart cells, and believe that the approach has tremendous promise to help patients suffering from severe heart and respiratory diseases.”Third Quarter 2020 Financial Results: * Net loss was $3.8 million for the third quarter of 2020, which is consistent with the $3.8 million net loss in the third quarter of 2019. * Research and development expenses were $2.5 million in the third quarter of 2020, compared to $2.0 million in the third quarter of 2019, primarily reflecting expenses incurred while conducting the Phase III pivotal CardiAMP Heart Failure Trial and pivotal CardiAMP Chronic Myocardial Ischemia Trial, and further developing the NK1R+ MSC program. * Selling, general and administrative expenses for the third quarter of 2020 totaled $1.4 million, which is consistent with the $1.4 million in the third quarter of 2019. * Net cash used in operations in the third quarter of 2020 was $3.6 million, compared to $1.5 million in the third quarter of 2019.Anticipated Upcoming Milestones in Q4 2020: * BCDA-01: Pre-specified Data Safety Monitoring Board Review, including a futility analysis, of all patients enrolled in the CardiAMP Heart Failure Trial at the time of the analysis based on 60 patients that should have reached the primary one-year follow-up endpoint * BCDA-02: First patient treated in CardiAMP Chronic Myocardial Ischemia Trial * BCDA-03: FDA acceptance of Investigational New Drug application for CardiALLO NK1R+ MSC therapy, the Company’s allogenic therapeutic platform, for the treatment of ischemic heart failure * BCDA-04: FDA acceptance of Investigational New Drug application for NK1R+ MSC therapy for the treatment of Acute Respiratory Distress Syndrome as a result of COVID-19About BioCardia BioCardia, Inc., headquartered in San Carlos, California, is developing regenerative biologic therapies to treat cardiovascular and respiratory disease. CardiAMP autologous and Neurokinin-1 Receptor Positive allogenic cell therapies are the Company’s biotherapeutic platforms in clinical development. The Company's products include the Helix Biotherapeutic Delivery System and its steerable guide and sheath catheter portfolio. BioCardia also partners with other biotherapeutic companies to provide its Helix system and clinical support for their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction. For more information, visit www.BioCardia.com.Forward Looking Statements  This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the enrollment of our clinical trials, the availability of data from our clinical trials, filings with the FDA, FDA product clearances, the efficacy and safety of our products and therapies, anticipated milestones, and other statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardia’s business and product development plans and overall market conditions. We may find it difficult to enroll patients in our clinical trials due to many factors, some of which are outside of our control. Slower than targeted enrollment could delay completion of our clinical trials and delay or prevent development of our therapeutic candidates. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in our documents filed with the SEC, including our recent filings on Form 8-K, Form 10-K and Form 10-Q, particularly any statements under the caption entitled “Risk Factors” Therein. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.Media Contact: Michelle McAdam, Chronic Communications, Inc. michelle@chronic-comm.com (310) 902-1274Investor Contact: David McClung, Chief Financial Officer Investors@BioCardia.com (650) 226-0120 BIOCARDIA, INC. Condensed Statements of Operations (Unaudited In thousands, except share and per share amounts)     Three Months ended September 30, Nine Months ended September 30,      2020  2019  2020  2019        Revenue:      Net product revenue$8 $1 $13 $139   Collaboration agreement revenue 26  193  86  356    Total revenue 34  194  99  495  Costs and expenses:          Cost of goods sold —  24  4  321   Research and development 2,474  2,007  7,484  6,392   Selling, general and administrative 1,408  1,390  4,642  4,460    Total costs and expenses 3,882  3,421  12,130  11,173    Operating loss (3,848) (3,227) (12,031) (10,678) Other income (expense):          Interest income 1  17  19  53   Gain on change in fair value of redemption feature embedded in convertible notes —  52  —  52   Interest expense (1) (112) (2) (112)  Loss on extinguishment of convertible notes —  (521) —  (521)  Other expense —  (1) (1) (2)   Total other income (expense) —  (565) 16  (530) Net loss $(3,848)$(3,792)$(12,015)$(11,208)              Net loss per share, basic and diluted$(0.30)$(0.63)$(1.33)$(2.13)              Weighted-average shares used in computing net loss per share, basic and diluted 12,618,285  6,030,662  9,059,433  5,263,058                          BIOCARDIA, INC.        Selected Balance Sheet Data         (amounts in thousands)                  September 30,   December 31,  2020 (1)   2019 (1)           Assets:        Cash and cash equivalents$7,392  $5,585  Other current assets 1,198   793  Property, plant and equipment and other noncurrent assets 912   1,300  Total assets$9,502  $7,678  Liabilities and Stockholders’ Equity        Current liabilities$4,320  $4,003  Noncurrent liabilities 1,069   1,305  Total stockholders’ equity 4,113   2,370  Total liabilities and stockholders’ equity$9,502  $7,678           (1) September 30, 2020 and 2019 amounts are unaudited. December 31, 2019 amounts were derived from the audited Consolidated Financial Statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission on April 9, 2020.

  • Published Peer-reviewed Initial Data from BioCardia Pivotal Phase 3 Clinical Trial of CardiAMP Demonstrates Improvement in Heart Failure Patients Measured by Exercise Outcomes and Cardiac Function
    GlobeNewswire

    Published Peer-reviewed Initial Data from BioCardia Pivotal Phase 3 Clinical Trial of CardiAMP Demonstrates Improvement in Heart Failure Patients Measured by Exercise Outcomes and Cardiac Function

    Paper Published in International Journal of Cardiology Demonstrates Safety and Tolerability While Showing Functional Improvement at Six Months SAN CARLOS, Calif., Oct. 26, 2020 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA](“BioCardia” or the “Company”), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the publication of data from the Company’s initial open-label roll-in cohort that served as the precursor for the Company’s ongoing CardiAMP™ Heart Failure (HF) Phase 3 clinical trial. Published in the International Journal of Cardiology, the study data shows that CardiAMP is a well-tolerated treatment in heart failure patients and demonstrated improved distance in six-minute exercise testing at six months and a trend toward improvement at one year. This 10-patient cohort was the feasibility test for the currently enrolling CardiAMP HF Phase 3 clinical trial.The study, entitled “Point of care, bone marrow mononuclear cell therapy in ischemic heart failure patients personalized for cell potency: 12-month feasibility results from CardiAMP heart failure roll-in cohort,” followed 10 patients with chronic post-heart attack heart failure (NYHA class II and III) who underwent a 5 ml bone marrow aspiration to determine cell potency using the patented CardiAMP cell potency assay followed by CardiAMP cell therapy, consisting of bone marrow mononuclear cell (BM MNC) enrichment and transendocardial injection of 200 million BM MNCs, at a subsequent single point-of-care visit. The study followed those subjects for 12 months and showed no serious adverse events related to bone marrow or cell delivery. Importantly, improvement at six months was observed in Six Minute Walk distance (+47.8 meters, p=0.01) and trended to improvement at 12 months (+46.4 meters, p=0.06). Echocardiographic data substantiated the improved performance of patients, as better contractility was seen of the heart.“These results surpassed what we saw in our Phase 2 trial in similar NYHA Class I, II, and III ischemic heart failure patients. Utilizing our cell potency assay is an important component of the CardiAMP treatment process, as it is the potency of the patients’ own cells that facilitates the regeneration and, therefore, the therapy. The results for these 10 patients are a meaningful marker for the heart failure community as a whole, and we believe it bodes well for our larger trial, for which these first patients laid the groundwork,” said BioCardia Chief Medical Officer Eric Duckers, M.D., Ph.D. “Our current CardiAMP HF trial is currently enrolling, and we anticipate full enrollment as early as the fourth quarter of 2021. In the meantime, we expect to receive the results from our data and safety monitoring board (DSMB) review by December 15, 2020.”The published paper also reported 12-month trends toward improvement in a variety of cardiac functions, including left ventricular ejection fraction and recruitment of previously akinetic left ventricular wall segments. The 10-patient cohort also displayed trends toward improvement of NYHA heart failure functional class and overall quality of life. The International Journal of Cardiology article is currently available online here and is expected to be available in print in the coming weeks.About BioCardia BioCardia, Inc., headquartered in San Carlos, California, is developing autologous and allogenic cell-based therapies to treat cardiovascular disease. CardiAMP™ and CardiALLO™ cell therapies are the Company’s biotherapeutic product candidates in clinical development. The Company has also developed a portfolio of approved enabling products that optimize delivery of its cell therapies.Forward Looking Statements  This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, the intended outcomes of and enrollment in our trials, the efficacy and safety of our products and therapies, and statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, obtaining regulatory approvals, and the ability to raise the additional funding needed to continue to pursue BioCardia’s product development plans. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate.  Additional factors that could materially affect actual results can be found in our documents filed with the SEC, including our recent filings on Form 8-K, Form 10-K and Form 10-Q, particularly any statements under the caption entitled “Risk Factors” therein.” BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. Media Contact: Michelle McAdam, Chronic Communications, Inc. michelle@chronic-comm.com (310) 902-1274Investor Contact: David McClung, Chief Financial Officer Investors@BioCardia.com (650) 226-0120

  • Read This Before Selling BioCardia, Inc. (NASDAQ:BCDA) Shares
    Simply Wall St.

    Read This Before Selling BioCardia, Inc. (NASDAQ:BCDA) Shares

    We've lost count of how many times insiders have accumulated shares in a company that goes on to improve markedly. On...