XML 22 R9.htm IDEA: XBRL DOCUMENT v3.8.0.1
Note 2 - Risks and Uncertainties
3 Months Ended
Mar. 31, 2018
Notes to Financial Statements  
Nature of Operations [Text Block]
2.
     Risks and Uncertainties
 
The Company operates in a highly regulated and competitive environment. The development, manufacturing and marketing of pharmaceutical products require approval from, and are subject to ongoing oversight by, the Food and Drug Administration (“FDA”) in the United States, the Therapeutic Goods Administration (“TGA”) in Australia, the European Medicines Agency (“EMA”) in the European Union, and comparable agencies in other countries. Obtaining approval for a new pharmaceutical product is never certain,
may
take many years, and is normally expected to involve substantial expenditures.
 
We have incurred losses of
$30.9
million since our inception in
2011.
For the
three
months ended
March 31, 2018,
we incurred a net loss of
$1.8
million, which includes a non-cash credit of
$1.1
million related to the waiver of contingent payment rights by certain employees offset by
$1.8
million of stock-based compensation expense. We also incurred negative cash flows from operating activities of
$0.6
million for this period. During this same period, we raised
$1.6
from the sale of equity securities. We expect to incur substantial losses for the foreseeable future, which will typically generate negative net cash flows from operating activities, as we continue to pursue development activities and seek to commercialize our initial product candidate, SBP-
101.
As of
March 31, 2018,
we had cash of
$1.2
million, working capital deficit of
$2.1
million due primarily to the current portion of convertible debt, and stockholders’ deficit of
$2.3
million. The Company’s principal sources of cash have historically included the issuance of convertible debt and equity securities.
 
The accompanying condensed consolidated financial statements have been prepared assuming that we will continue as a going concern which contemplates the realization of assets and liquidation of liabilities in the normal course of business. The condensed
consolidated financial statements do
not
include any adjustments relating to the recoverability or classification of assets or the amounts of liabilities that might result from the outcome of these uncertainties. Our current independent registered public accounting firm, included a paragraph emphasizing this going concern uncertainty in their audit report regarding our
2017
financial statements dated
March 21, 2018.
Our ability to continue as a going concern, realize the carrying value of our assets and discharge our liabilities in the ordinary course of business is dependent upon a number of factors, including our ability to obtain additional financing, the success of our development efforts, our ability to obtain marketing approval for our SBP-
101
product candidate in the United States, Australia, the European Union or other markets and ultimately our ability to market and sell our SBP-
101
product candidate. These factors, among others, raise substantial doubt about our ability to continue operations as a going concern. See Note
4
titled “Liquidity and Management’s Plans.”