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Note 2 - Significant Accounting Policies
9 Months Ended
Sep. 30, 2020
Notes to Financial Statements  
Significant Accounting Policies [Text Block]
(
2
)
Significant Accounting Policies
 
 
(a)
Basis of Preparation
 
 
 
 
 
The accompanying condensed consolidated balance sheets, statements of operations, shareholders' equity, and cash flows as of
September 30, 2020
and for the
three
and
nine
months ended
September 30, 2020
and
2019
are unaudited. The condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (U.S. GAAP) and applicable rules and regulations of the Securities and Exchange Commission (SEC) for interim financial information and on a basis consistent with the annual financial statements and, in the opinion of management, reflect all adjustments which include only normal recurring adjustments, necessary to present fairly its financial position as of
September 30, 2020,
results of operations for the
three
and
nine
months ended
September 30, 2020
and
2019,
and cash flows for the
nine
months ended
September 30, 2020
and
2019.
The results for the
three
and
nine
months ended
September 30, 2020
are
not
necessarily indicative of the results to be expected for the year ended
December 31, 2020
or for any other interim period or for any other future year.
 
 
 
 
 
These condensed consolidated financial statements should be read in conjunction with the audited financial statements and related notes included in the Company's Annual Report on Form
10
-K for the year ended
December 31, 2019,
filed with the SEC on
April 9, 2020. 
 
The results for the
three
months ended
September 30, 2020
are
not
necessarily indicative of the results to be expected for the year ending
December 31, 2020
or for any other interim period or for any other future year, particularly in light of the novel coronavirus pandemic, or COVID-
19,
and its impact on domestic and global economies. To limit the spread of COVID-
19,
governments have taken various actions including the issuance of stay-at-home orders and social distancing guidelines, causing some businesses to suspend operations and/or experience a reduction in demand for many products from direct or ultimate customers. Accordingly, businesses have adjusted, reduced or suspended operating activities and are continuing to adapt to these changing actions and guidelines.
 
Beginning
March 17, 2020,
substantially all of the Company's workforce began working from home. On
April 6,
manufacturing operations resumed at the Company's facilities, with substantially all other staff continuing to work from home. While the direct effects of the stay-at-home orders and BioCardia's work-from-home policies have been largely mitigated during the
three
months ended
September 30, 2020,
the overall impact of the pandemic has resulted in disruption to the Company's business and resulted in delays in the Company's development programs and regulatory and commercialization timelines. The overall magnitude of the continuing impact will depend, in part, on the length and severity of changing restrictions and other limitations on BioCardia's ability to conduct the Company's business. BioCardia's future research and development expenses and general and administrative expenses
may
vary significantly if the Company experiences an increased impact from COVID-
19
on the costs and timing associated with the conduct of BioCardia's clinical trials and other related business activities. 
 
   
BioCardia's ability to raise additional funds
may
be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from the ongoing COVID-
19
pandemic.
 
 
(b)
Liquidity and Other Risks and Uncertainties
 
 
 
 
 
Going Concern and Liquidity
- The Company has incurred net losses and negative cash flows from operations since its inception and had an accumulated deficit of
$113.1
million as of
September 30, 2020.
Management expects operating losses and negative cash flows to continue through at least the next several years. The Company expects to incur increasing costs as it advances its trials and development activities. Therefore, absent additional funding, management believes cash and cash equivalents of
$7.4
million as of
September 30, 2020
are
not
sufficient to fund the Company beyond the
second
quarter of
2021.
These factors raise substantial doubt about the Company's ability to continue as a going concern beyond
one
year from the date these financial statements are issued. The financial statements do
not
include any adjustments that might result from the outcome of this uncertainty.
 
 
 
 
 
The Company's ability to continue as a going concern and to continue further development of its therapeutic candidates beyond the
second
quarter of
2021,
will require the Company to raise additional capital. The Company plans to raise additional capital, potentially including debt and equity arrangements, to finance its future operations. While management believes this plan to raise additional funds will alleviate the conditions that raise substantial doubt, these plans are
not
entirely within its control and cannot be assessed as being probable of occurring.  If adequate funds are
not
available, the Company
may
be required to reduce operating expenses, delay or reduce the scope of its product development programs, obtain funds through arrangements with others that
may
require the Company to relinquish rights to certain of its technologies or products that the Company would otherwise seek to develop or commercialize itself, or cease operations.
 
 
 
 
(c)
Use of Estimates
 
 
 
 
 
The preparation of the financial statements in accordance with U.S. GAAP requires management to make certain estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ materially from those estimates. Significant items subject to such estimates and assumptions include share-based compensation, the useful lives of property and equipment, right-of-use assets and related liabilities, incremental borrowing rate, allowances for doubtful accounts and sales returns, derivative instruments, clinical accruals, and inventory valuation.
 
 
(d)
Principles of Consolidation
 
 
 
 
 
The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany accounts and transactions have been eliminated during the consolidation process.
 
 
(e)
Changes to Significant Accounting Policies
 
 
 
 
 
The Company's significant accounting policies are described in Note
2
of the notes to the consolidated financial statements included in its Annual Report on Form
10
-K filed
April 9, 2020
for the year ended
December 31, 2019.
There have been
no
changes to those policies.
 
 
(f)
Recently Issued Accounting Pronouncements
 
 
 
 
 
Recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force did
not
or are
not
believed by management to have a material impact on the Company's financial statement presentation or disclosures.