BioCardia®, Inc. BCDA, a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today reported financial results and provided a corporate update for the third quarter ended September 30, 2017.
BioCardia reported a net loss of $3.0 million for the third quarter of 2017, which compares to a net loss of $3.3 million for the third quarter of 2016. Research and development expenses were $1.7 million for the third quarter of 2017, compared to $684,000 in the third quarter of 2016, primarily due to expenses incurred for the pivotal CardiAMP Heart Failure Trial (CardiAMP HF Trial). Selling, general and administrative expenses were $1.3 million for the third quarter of 2017, compared to $919,000 in the third quarter of 2016, primarily due to additional costs for the organizational structure needed to support the CardiAMP HF Trial and operations as a public company.
BioCardia CEO Peter Altman, PhD, stated, "These financial results demonstrate BioCardia's efficiency in its use of capital while conducting the CardiAMP HF Trial. The trial has received Investigational Device Exemption (IDE) Category B reimbursement designation from the Centers for Medicare and Medicaid Services. This significantly reduces the overall development cost of the program."
Recent accomplishments include:
- Successful data safety monitoring board review of the roll-in cohort in the CardiAMP HF Trial,
- Activation of five world-class cardiovascular centers enrolling patients in the trial today,
- Launch of the patient recruitment website, www.CardiAMP.com,
- Appointment of Ian McNiece, PhD, as Chief Scientific Officer,
- Publication of the positive Phase II results from our co-sponsored TRIDENT trial evaluating allogeneic mesenchymal stem cells in heart failure in Circulation Research, and
- Issuance of US Patent No. 9,301,975 relating to a method of producing mesenchymal stem cells from bone marrow cells, and US Patent No. 9,775,963 related to steerable devices.
BioCardia Chief Medical Officer Dr. Eric Duckers, MD, PhD, said, "The ongoing CardiAMP pivotal trial in ischemic heart failure and the anticipated submission of CardiAMP in the related indication of chronic myocardial ischemia are supported by our CardiAMP Phase I open-label TABMMI ischemic heart failure trial and the Phase 2 randomized placebo-controlled TACHFT-BMC ischemic heart failure trial. In both trials, patients who received cells experienced clinically meaningful and statistically significant improvements in established endpoints of exercise tolerance, while also demonstrating positive changes to their heart geometries. These results are also supported by a recent meta-analysis of 21 randomized controlled trials of bone marrow-derived cells for treating ischemic heart disease, which showed a significant reduction in mortality at long term follow-up in patients who received cells when compared to those who did not receive cells."
Looking forward, the Company anticipates submitting an IDE supplement to enable an interim analysis on efficacy at the end of 2018, and having top line data available at the end of 2019. The Company also anticipates filing a second IDE with the FDA for a CardiAMP Chronic Myocardial Ischemia Trial in 2017.
About BioCardia®
BioCardia, Inc., headquartered in San Carlos, CA, is developing regenerative biologic therapies to treat cardiovascular disease. CardiAMP® and CardiALLO® cell therapies are the Company's biotherapeutic product candidates in clinical development. The Company's current products include the Helix™ transendocardial delivery system and the Morph® steerable guide and sheath catheter portfolio. BioCardia also partners with other biotherapeutic companies to provide its Helix systems and clinical support to their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction.
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 CardiAMP HF Trial, the efficacy and safety of our products and therapies, statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such factors 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, which could delay or prevent development of our therapeutic candidates. The rate of enrollment will depend upon the number of clinical sites and their ability to recruit patients that fit our trial profiles, and there could be delays beyond our control. 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, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this presentation. As a result of these factors, we cannot assure you that the forward-looking statements in this presentation 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 30, 2017, including under the caption titled "Risk Factors." BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
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BIOCARDIA, INC. Condensed Statements of Operations (Unaudited in thousands, except share and per share amounts) |
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Three Months ended |
Nine Months ended |
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| 2017 | 2016 | 2017 | 2016 | ||||||||||||||||||||||
| Revenue: | |||||||||||||||||||||||||
| Net product revenue | $ | 88 | $ | 100 | $ | 298 | $ | 406 | |||||||||||||||||
| Collaboration agreement revenue | 42 | 17 | 81 | 33 | |||||||||||||||||||||
| Total revenue | 130 | 117 | 379 | 439 | |||||||||||||||||||||
| Costs and expenses: | |||||||||||||||||||||||||
| Cost of goods sold | 147 | 196 | 525 | 578 | |||||||||||||||||||||
| Research and development | 1,700 | 684 | 4,028 | 1,622 | |||||||||||||||||||||
| Selling, general and administrative | 1,322 | 919 | 4,708 | 2,375 | |||||||||||||||||||||
| Total costs and expenses | 3,169 | 1,799 | 9,261 | 4,575 | |||||||||||||||||||||
| Operating loss | (3,039 | ) | (1,682 | ) | (8,882 | ) | (4,136 | ) | |||||||||||||||||
| Other income (expense): | |||||||||||||||||||||||||
| Interest income | 35 | — | 58 | — | |||||||||||||||||||||
| Interest expense | — | (520 | ) | — | (1,627 | ) | |||||||||||||||||||
| Change in fair value of convertible preferred stock warrant liability | — | 30 | — | 250 | |||||||||||||||||||||
| Change in fair value of maturity date preferred stock warrant liability | — | 3 | — | 10 | |||||||||||||||||||||
| Change in fair value of convertible shareholder notes derivative liability | — | (1,085 | ) | — | (1,224 | ) | |||||||||||||||||||
| Other expense | 3 | — | 2 | (1 | ) | ||||||||||||||||||||
| Total other income (expense), net | 38 | (1,572 | ) | 60 | (2,592 | ) | |||||||||||||||||||
| Net loss | $ | (3,001 | ) | $ | (3,254 | ) | $ | (8,822 | ) | $ | (6,728 | ) | |||||||||||||
| Net loss per share, basic and diluted | $ | (0.08 | ) | $ | (2.06 | ) | $ | (0.23 | ) | $ | (4.26 | ) | |||||||||||||
| Weighted-average shares used in computing net loss per share, basic and diluted |
38,146,751 |
1,579,852 |
38,141,654 |
1,579,264 |
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| BIOCARDIA, INC. | ||||||
| Selected Balance Sheet Data (unaudited) | ||||||
| (amounts in thousands) | ||||||
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September 30, |
December 31, |
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| Assets: | ||||||
| Cash, cash equivalents and short-term investments | $ | 15,125 | $ | 21,352 | ||
| Other current assets | 518 | 565 | ||||
| Property, plant and equipment and other noncurrent assets | 217 | 165 | ||||
| Total assets | $ | 15,860 | $ | 22,082 | ||
| Liabilities and Stockholders' Equity | ||||||
| Current liabilities | $ | 2,000 | $ | 1,444 | ||
| Noncurrent liabilities | 75 | 56 | ||||
| Total stockholders' equity | 13,785 | 20,582 | ||||
| Total liabilities and stockholders' equity | $ | 15,860 | $ | 22,082 | ||
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