SUNNYVALE, Calif., March 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 reported financial results for the year ended December 31, 2022 and filed its annual report on Form 10-K for the year ended December 31, 2022 with the Securities and Exchange Commission. The Company will also hold an update conference call at 4:30 PM ET today in which it will discuss business highlights with call details below.
“I am tremendously proud of the BioCardia team and its clinical partners for the regulatory, reimbursement and clinical progress we have made over the last year,” said BioCardia CEO Peter Altman, Ph.D. “We are now advancing four novel autologous and allogeneic cell therapies in clinical studies, each of which is delivered locally to the heart or the lungs, where they are intended to stimulate natural reparative processes and reduce inflammation. This year holds the potential for catalysts that could dramatically improve our prospects, timetable, and attractiveness as a business. We are excited about what the future holds and are grateful for the opportunity in front of us to create an entirely new class of heart failure treatments with the potential to transform cardiovascular and pulmonary care.”
RECENT BUSINESS HIGHLIGHTS:
CardiAMP® Cell Therapy for Heart Failure (FDA Breakthrough Device Designation) and Chronic Myocardial Ischemia
Allogeneic Cell Therapy for Ischemic Heart Failure with Reduced Ejection Fraction (HFrEF) and Acute Respiratory Distress Syndrome (ARDS)
Business Development
2022 FINANCIAL RESULTS:
ANTICIPATED UPCOMING MILESTONES AND EVENTS:
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/10176505/f628d93f3b. 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=UglsZgDF., which is also available through the company’s website.
A webcast replay of the call will be available approximately one hour after the end of the call through June 29, 2023 at the above links. A telephonic replay of the call will be available through April 12, 2023 and may be accessed by calling 1-877-344-7529 (domestic) or 1-412-317-0088 (international) and using access code 9731926.
ABOUT BIOCARDIA®
BioCardia, Inc., headquartered in Sunnyvale, California, is a developer of two biotherapeutic platforms – the CardiAMP autologous bone marrow derived mononuclear cell therapy for cardiovascular indications, and the NK1R+ allogeneic bone marrow derived mesenchymal stem cell therapy for cardiovascular and pulmonary diseases. These platforms underly four product candidates, each with the potential to meaningfully benefit millions of patients. Three of BioCardia’s investigational therapies are enabled by the Company’s proprietary biotherapeutic delivery platform, which the Company also selectively licenses to other biotherapeutic development firms. The CardiAMP Cell Therapy Heart Failure Trial has been supported financially by the Maryland Stem Cell Research Fund and the Center for Medicare and Medicaid Services. 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 and Japan’s Pharmaceutical and Medical Device Agency, FDA and Japanese product clearances, the efficacy and safety of our products and therapies, preliminary conclusions about new data, the achievement of any of the anticipated upcoming milestones, our positioning for growth or the market for our products and therapies, 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, the ability to enter into licensing and partnering arrangements 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 BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 29, 2023, under the caption titled “Risk Factors.” BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
Media Contact:
Anne Laluc, Marketing
Email: alaluc@BioCardia.com
Phone: 650-226-0120
Investor Contact:
David McClung, Chief Financial Officer
Email: investors@BioCardia.com
Phone: 650-226-0120
BioCardia, Inc.
Consolidated Statements of Operations
(in thousands, except share and per share amounts)
Year ended December 31, |
||||||||
2022 | 2021 | |||||||
Revenue: | ||||||||
Net product revenue | $ | 3 | $ | 1 | ||||
Collaboration agreement revenue | 1,349 | 1,014 | ||||||
Total revenue | 1,352 | 1,015 | ||||||
Costs and expenses: | ||||||||
Research and development | 8,834 | 8,558 | ||||||
Selling, general and administrative | 4,419 | 5,087 | ||||||
Total costs and expenses | 13,253 | 13,645 | ||||||
Operating loss | (11,901 | ) | (12,630 | ) | ||||
Other income (expense): | ||||||||
Total other income (expense), net | (6 | ) | 7 | |||||
Net loss | $ | (11,907 | ) | $ | (12,623 | ) | ||
Net loss per share, basic and diluted | $ | (0.67 | ) | $ | (0.75 | ) | ||
Weighted-average shares used in computing net loss per share, basic and diluted | 17,720,972 | 16,917,664 |
BioCardia, Inc.
Selected Balance Sheet Data
(amounts in thousands)
December 31, | December 31, | |||||||
2022(1) | 2021(1) | |||||||
Assets: | ||||||||
Cash and cash equivalents | $ | 7,363 | $ | 12,872 | ||||
Other current assets | 501 | 609 | ||||||
Property, plant and equipment and other noncurrent assets | 1,929 | 2,237 | ||||||
Total assets | $ | 9,793 | $ | 15,718 | ||||
Liabilities and Stockholders’ Equity | ||||||||
Current liabilities | $ | 3,585 | $ | 3,712 | ||||
Operating lease liability – noncurrent | 1,316 | 1,631 | ||||||
Total stockholders’ equity | 4,892 | 10,375 | ||||||
Total liabilities and stockholders’ equity | $ | 9,793 | $ | 15,718 | ||||
(1) December 31, 2022 and 2021 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, 2022, filed with the U.S. Securities and Exchange Commission on March 29, 2023. |
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