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Liquidity and Uncertainties
12 Months Ended
Dec. 31, 2019
Risks and Uncertainties [Abstract]  
Liquidity and Uncertainties

Note 2 — Liquidity and Uncertainties:

 

The financial statements have been prepared in conformity with generally accepted accounting principles which contemplate continuation of the Company as a going concern. To date, the Company's commercial operations have not generated sufficient revenues to enable profitability. As of December 31, 2019, the Company had an accumulated deficit of $195.4 million, and incurred net losses of $16.4 million and $26.8 million for the years ended December 31, 2019 and 2018, respectively. Based on the Company's current development plans for Neutrolin in both the U.S. and foreign markets and its other operating requirements, the Company's existing cash and cash equivalents at December 31, 2019 are expected to fund its operations into the second quarter of 2021, after taking into consideration the net proceeds received through March 12, 2020 from the At-the-Market Issuance Sales Agreement (the "ATM program") of $2.5 million and the exercise of warrants of $0.4 million (see Note 11).

 

The Company's continued operations will depend on its ability to raise additional capital through various potential sources, such as equity and/or debt financings, strategic relationships, potential strategic transactions or out-licensing of its products in order to undertake a second Phase 3 clinical trial, if required by the FDA, commercially launch Neutrolin upon NDA approval and until profitability is achieved, if ever. Management can provide no assurances that such financing or strategic relationships will be available on acceptable terms, or at all. As of the filing date of this Annual Report on Form 10-K, the Company has approximately $2.1 million available under its current ATM program and $30.3 million available under its current shelf registration for the issuance of equity, debt or equity-linked securities unrelated to the current ATM program.

 

The Company's operations are subject to a number of other factors that can affect its operating results and financial condition. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Company's product candidates; the ability to obtain regulatory approval to market the Company's products; ability to manufacture successfully; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, Company products; the Company's ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; and the Company's ability to raise capital to support its operations.