SUNNYVALE, Calif., May 21, 2024 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that, following approval by the Company’s stockholders and its Board of Directors, the Company intends to effect a reverse stock split of its common stock at a ratio of 1 post-split share for every 15 pre-split shares. The reverse stock split will become effective at 12:01 a.m. Eastern Daylight Time on Thursday, May 30, 2024. The Company’s common stock will begin trading on a split-adjusted basis when the market opens on Thursday, May 30, 2024. The Company’s common stock and warrants will continue to be traded on The Nasdaq Capital Market under the ticker symbols “BCDA” and “BCDAW,” respectively. The reverse stock split is intended to increase the minimum bid price requirement for continued listing on The Nasdaq Capital Market. The Company, however, cannot assure that the price of its common stock after the reverse stock split will reflect the corresponding split ratio, that the price per share following the effective time will be maintained for any period of time, or that the price will remain above the pre-split trading price. At the effective time of the reverse stock split, every 15 shares of the Company’s issued and outstanding common stock will be converted automatically into one issued and outstanding share of common stock. Stockholders holding their shares electronically in book-entry form are not required to take any action to receive post-split shares. Stockholders owning shares through a bank, broker, or other nominee will have their positions automatically adjusted to reflect the reverse stock split, subject to brokers’ particular processes, and will not be required to take any action in connection with the reverse stock split. For those stockholders holding physical stock certificates, the Company’s transfer agent, Continental Stock Transfer & Trust Co., will send instructions for exchanging those certificates for shares held electronically in book-entry form or for new certificates, in either case representing the post-split number of shares, and any payments in cash in lieu of fractional shares, if applicable. The reverse stock split will affect all stockholders uniformly and will not alter any stockholder’s percentage interest in the Company’s equity, except to the extent that the reverse stock split would result in a stockholder owning a fractional share. No fractional shares will be issued in connection with the reverse stock split. Stockholders who would otherwise hold a fractional share of the Company’s common stock following the reverse stock split will receive a cash payment in lieu thereof at a price equal to that fractional share to which the stockholder would otherwise be entitled multiplied by the closing sale price of the common stock on The Nasdaq Capital Market, as adjusted for the reverse stock split, May 29, 2024. Proportional adjustments will be made to the number of shares of common stock issuable upon exercise or conversion of the Company’s equity awards and warrants, the applicable exercise or conversion price and the number of shares issuable under the Company’s equity plans. Following the reverse stock split, the Company’s common stock will have a new CUSIP number (09060U 606). The CUSIP number for the Company’s public warrants will not change. In connection with the reverse stock split, the Company will effect an adjustment to its authorized shares of common stock, such that the 100,000,000 authorized shares of common stock will be reduced to 50,000,000 authorized shares of common stock. The par value per share of common stock and number of authorized shares of preferred stock will not change. Additional information about the reverse stock split can be found in the Company’s definitive proxy statement filed with the SEC on April 15, 2024, which is available free of charge at the SEC’s website, www.sec.gov, and on the Company’s website at https://www.biocardia.com/investors/finanicals-filings/id/1021. About BioCardia® BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP autologous and CardiALLO allogeneic cell therapies are the Company’s biotherapeutic platforms for the treatment of heart disease. BioCardia also works with partners to provide its proprietary biotherapeutic delivery system along with preclinical and clinical development services for biotherapeutic delivery to the heart. 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, statements regarding the timing and effectiveness of the reverse stock split and the Company’s ability to regain compliance with Nasdaq’s minimum bid price. These forward-looking statements are made as of the date of this press release. 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. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s liquidity position and its ability to raise additional funds, as well as the Company’s ability to successfully advance its clinical trials. 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 BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 29, 2023, under the caption titled “Risk Factors,” and in its subsequently filed Quarterly Reports on Form 10-Q. The Company expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
Tag: BioCardia
BioCardia’s CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial Results Show Patient Benefits in Important Outcomes
SUNNYVALE, Calif., May 01, 2024 (GLOBE NEWSWIRE) — BioCardia, Inc. (NASDAQ: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the primary endpoint results of the open label roll-in cohort of the CardiAMP® Cell Therapy in Chronic Myocardial Ischemia Trial.
BioCardia to Host 2023 Financial Results and Corporate Update Conference Call on March 27, 2024
SUNNYVALE, Calif., March 20, 2024 (GLOBE NEWSWIRE) — BioCardia®, Inc. [NASDAQ:BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced it will report its financial results for the year ended December 31, 2023 and provide a corporate update by conference call on Wednesday, March 27, 2024 at 4:30 PM ET. Following management’s formal remarks, there will be a question-and-answer session. Participants can register for the conference by navigating to https://dpregister.com/sreg/10187416/fbec8cfa30. Please note that registered participants will receive their dial-in number upon registration. For those who have not registered, to listen to the call by phone, interested parties within the U.S. should call 1-833-316-0559 and international callers should call 1-412-317-5730. All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the BioCardia call. The conference call will also be available through a live webcast, which can be accessed through the following link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=Ya3BT5pb. A webcast replay of the call will be available approximately one hour after the end of the call through June 26, 2024 at the above links. A telephonic replay of the call will be available through April 10, 2024 and may be accessed by calling 1-877-344-7529 (domestic), 1-412-317-0088 (international) or 855-669-9658 (Canada) by using access code 3499879. About BioCardia®BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP autologous and CardiALLO allogeneic cell therapies are the Company’s biotherapeutic platforms for the treatment of heart disease. BioCardia also works with partners to provide its proprietary Helix transendocardial biotherapeutic delivery system, as well as technology and services for the development and commercialization of partners’ therapeutic agents. For more information visit www.biocardia.com. MEDIA CONTACT:Miranda Peto, Marketing / Investor Relations mpeto@biocardia.com (650) 226-0120 INVESTOR CONTACT:David McClung, Chief Financial Officerinvestors@biocardia.com (650) 226-0120
BioCardia and StemCardia Announce Biotherapeutic Delivery Partnership
Partnership targets heart failure, the leading cause of death and a condition with limited treatment optionsBioCardia’s biotherapeutic delivery system with established safety profile enables minimally invasive transplantation of StemCardia’s off-the-shelf cardiac muscle cells SUNNYVALE, Calif., March 13, 2024 (GLOBE NEWSWIRE) — BioCardia, Inc. (Nasdaq: BCDA), a biotechnology company focused on advancing late-stage cell therapy interventions for cardiovascular disorders, and StemCardia, Inc., a biotechnology company focused on cell and gene therapy to re-muscularize the failing heart, today announced a long-term partnership to advance StemCardia’s investigational pluripotent stem cell product candidate for the treatment of heart failure. Under the partnership, BioCardia is the exclusive biotherapeutic delivery partner for StemCardia’s cell therapy candidate through studies expected to result in FDA approval of an investigational new drug application (IND) and the anticipated Phase I/II clinical development to follow. “BioCardia has established safe and minimally invasive delivery of cellular medicines directly into the heart,” said Chuck Murry, MD, PhD, StemCardia’s Founder and CEO. “Having worked with BioCardia to successfully deliver our bona fide cardiac muscle cells in large animal models of heart failure, we are excited for this partnership to accelerate clinical development and broaden future commercial access to an off-the-shelf heart regeneration treatment.” “StemCardia’s team encompasses recognized leaders in the field of cardiac regenerative medicine who are pursuing an elegant strategy to repair the failing heart. We look forward to supporting their efforts with our experienced team and proven, proprietary Helix™ biotherapeutic delivery system,” said BioCardia CEO Peter Altman, PhD. “This partnership is expected to enhance future treatment options for millions of people suffering from heart failure, offset the costs of biotherapeutic delivery development for our own programs, and provide our investors with meaningful revenue sharing should our efforts together contribute to StemCardia’s successful therapeutic development.” About StemCardia StemCardia, Inc., is developing cell and gene therapies engineered to repair the heart. The company’s mission is to advance off-the-shelf treatments for heart failure, bringing together leading experts in heart regeneration, cell manufacturing, and genetic medicine. Few treatments are available today, and none are curative. Inspired by the observation that the heart does not regenerate itself, our unique approach is to manufacture and transplant cardiac muscle cells to directly re-muscularize the failing heart and restore its function. About BioCardia BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP autologous and CardiALLO allogeneic cell therapies are the Company’s biotherapeutic platforms for the treatment of heart disease. BioCardia also works with partners to provide its proprietary Helix transendocardial biotherapeutic delivery system, as well as technology and services for the development and commercialization of partners’ therapeutic agents. About Helix The Helix transendocardial biotherapeutic delivery system is a therapeutic-enabling platform for minimally invasive targeted delivery of biologic agents to the heart. Helix empowers a seamless transition from bench to commercialization for partners. 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 potential for the therapy and the partnership, future revenues and cost offsetting and future clinical trials. 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. 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. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s liquidity position and its ability to raise additional funds, as well as the Company’s ability to successfully progress its clinical trials. 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 BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 29, 2023, under the caption titled “Risk Factors” and in its subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. BioCardia Investor Relations and Media Contact:David McClung, Chief Financial Officerinvestors@biocardia.com, 650-226-0120 StemCardia Investor Relations and Media Contact:Raj Mistry, Chief Financial Officer info@stemcardia.com
BioCardia Announces CMS Approval of Coverage for CardiAMP Cell Therapy Confirmatory Phase III Heart Failure Study
SUNNYVALE, Calif., March 12, 2024 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced Centers for Medicare & Medicaid Services (CMS) approval for reimbursement coverage of the confirmatory Phase III clinical trial of CardiAMP autologous cell therapy for the treatment of patients with ischemic heart failure. CMS has reviewed the CardiAMP Heart Failure II Trial and approved the investigational product, related and routine items and services for purposes of Medicare coverage. CMS previously published a New Technology APC (Ambulatory Payment Classifications) code that covers the CardiAMP Cell Therapy investigational study procedure, including the BioCardia investigational products utilized to perform the study procedure, allowing the study centers to be reimbursed for the study procedure and products. The CardiAMP Heart Failure II Trial is FDA approved to enroll up to 250 patients at up to 40 clinical centers. The study includes an eligibility requirement that patients demonstrate a pre-specified NT-proBNP level at baseline. The primary endpoint is a hierarchical composite assessment consisting of all-cause death, the cardiac death equivalents of heart transplant and left ventricular assist device (LVAD) implantation, heart failure hospitalizations, worsening heart failure events treated as an outpatient, and change in quality-of-life, with a follow-up duration ranging from a minimum of 12 to a maximum of 24 months. The CMS coverage approval is supported by the scientific rigor of the protocol design and the results from the interim data from the CardiAMP Heart Failure Trial recently presented at the Technology and Heart Failure Therapeutics 2024 annual meeting. Across all patients there was a reduction in cardiac death equivalents and major adverse cardiac and cerebrovascular events. In the subgroup of patients targeted in the CardiAMP Heart Failure II Trial, results showed large absolute and relative risk reduction of heart death equivalents of the patients in the treated group. Treated patients also had reduced major adverse cardiac events and greatly improved quality of life. “We are pleased that CMS has provided coverage support for the confirmatory CardiAMP Heart Failure II study.” said Peter Altman, PhD., BioCardia’s President and Chief Executive Officer. “To my knowledge, no therapy has been proven to reduce mortality in these patients, and CardiAMP Heart Failure II has great potential to achieve this outcome by confirming our CardiAMP Heart Failure Trial results.” About the CardiAMP Cell Therapy Program Designated by the FDA as a Breakthrough Therapy, CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response. CardiAMP Cell Therapy incorporates three proprietary elements not previously utilized in investigational cardiac cell therapy: a pre-procedural cell analysis for patient selection, a high target dosage of cells, and a proprietary delivery system that has been shown to be safer than other intramyocardial delivery systems and exponentially more successful in cell retention. The CardiAMP clinical development for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by CMS for both treatment and control procedures. CAUTION – Limited by United States law to investigational use. About BioCardia® BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP autologous and CardiALLO allogeneic cell therapies are the Company’s biotherapeutic platforms for the treatment of heart disease. BioCardia also works with partners to provide its proprietary biotherapeutic delivery system along with preclinical and clinical development services for biotherapeutic delivery to the heart. 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, statements relating to completing follow-up in the CardiAMP Heart Failure Trial, the probability of success of the CardiAMP clinical trials, ability to offset clinical costs utilizing Medicare reimbursement, anticipated milestones and events, and the ultimate success of our clinical cell therapy programs. These forward-looking statements are made as of the date of this press release. 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. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s liquidity position and its ability to raise additional funds, as well as the Company’s ability to successfully advance its clinical trials. 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 BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 29, 2023, under the caption titled “Risk Factors” and in its subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. Media Contact: Miranda Peto, Marketing / Investor RelationsEmail: mpeto@BioCardia.comPhone: 650-226-0120 Investor Contact: David McClung, Chief Financial OfficerEmail: investors@BioCardia.comPhone: 650-226-0120
BioCardia Reports Positive Interim Results from Phase III CardiAMP Cell Therapy Heart Failure Trial, with Compelling Data in Subgroup with Elevated NTproBNP Biomarker for Heart Failure
CardiAMP cell therapy-treated patients had 37% relative risk reduction in heart death equivalent (death, heart transplant, left ventricular assist device implantation) and 9% relative risk reduction in non-fatal major adverse cardiac and cerebrovascular events (MACCE) at mean 20-month follow-up compared […]
BioCardia Announces Activation of CardiAMP Heart Failure II Phase 3 Pivotal Study Recently Approved by FDA
SUNNYVALE, Calif., Feb. 08, 2024 (GLOBE NEWSWIRE) — BioCardia, Inc. (“BioCardia” or the “Company”) (Nasdaq: BCDA), a biotechnology company focused on advancing late-stage cell therapy interventions for cardiovascular disorders, is targeting heart failure and chronic myocardial ischemia as potential indications for […]
BioCardia Doses First Patient in CardiALLO Phase I/II Clinical Trial of BCDA-03 Allogeneic Mesenchymal Stem Cells for the Treatment of Ischemic Heart Failure of Reduced Ejection Fraction
SUNNYVALE, Calif., Dec. 19, 2023 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease, today announced that the first patient was enrolled and treated in its CardiALLO™ Allogeneic […]
BioCardia Announces Expected CardiAMP Heart Failure Japan Approval Timeline Based on Pharmaceutical and Medical Device Agency Consultation Minutes
SUNNYVALE, Calif., Dec. 18, 2023 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that Japan Pharmaceutical and Medical Device Agency (PMDA) minutes support the […]
BioCardia Shares Update from Japan PMDA Consultation on CardiAMP Autologous Cell Therapy for Ischemic Heart Failure; Foreign Data Expected to be Sufficient for Product Approval
SUNNYVALE, Calif., Nov. 29, 2023 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today provided an update after its recent consultation with Japan’s Pharmaceutical and Medical […]