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Liquidity and Going Concern

9 Months Ended

Sep. 30, 2020

3.	Liquidity and Going Concern

The Company incurred net losses of $1.7 million and $4.7 million for the three and nine months ended September 30, 2020, respectively. The Company had an accumulated deficit of $429.9 million as of September 30, 2020. Additionally, it used net cash of $5.2 million to fund its operating activities for the nine months ended September 30, 2020. These factors raise substantial doubt about the Company’s ability to continue as a going concern.

To date, these operating losses have been funded primarily from outside sources of invested capital, proceeds raised from the Loan and Security Agreement, and gross profits. The Company has had, and will continue to have, an ongoing need to raise additional cash from outside sources to fund its future clinical development programs and other operations. The Company anticipates using its new equity line facility entered into on September 30, 2020 with Lincoln Park Capital Fund, LLC (“Lincoln Park”) (Note 11) to raise additional cash. The Company’s inability to raise additional cash would have a material and adverse impact on its business and operations and would cause it to default on its loan.

The Company continues to seek additional capital through strategic transactions and from other financing alternatives. Without additional capital, the Company’s current working capital will not provide adequate funding to make debt repayments or support its research, sales and marketing efforts and product development activities at their current levels. If sufficient additional capital is not raised, the Company will at a minimum need to significantly reduce or curtail its research and development and other operations, and this would negatively affect its ability to achieve corporate growth goals.

The accompanying consolidated condensed financial statements have been prepared assuming the Company will continue to operate as a going concern, which contemplates the realization of assets and settlement of liabilities in the normal course of business, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from uncertainty related to its ability to continue as a going concern.