Risks and Uncertainties

3 Months Ended

Mar. 31, 2023

Risks and Uncertainties [Abstract]

Risks and Uncertainties

Risks and Uncertainties

The Company assesses liquidity in terms of its ability to generate cash to fund its operating, investing and financing activities. The Company’s cash requirements for 2023 and beyond include expenses related to continuing development and clinical evaluation of its products, manufacture and supply costs, costs of regulatory filings, patent prosecution expenses and litigation expenses, expenses related to commercialization of its products, as well as costs to comply with the requirements of being a public company operating in a highly regulated industry. As of March 31, 2023, the Company had $26,882 of cash and cash equivalents.

The Company has experienced a history of net losses in prior periods. The Company's accumulated deficits totaled $303,139 as of March 31, 2023. The net losses and accumulated deficits were partially offset by gross margins from license fees, milestone and royalty payments from commercial licensees and co-development parties. The Company's funding requirements have been met by its cash and cash equivalents, as well as its existing equity and debt offerings, including the 12.5% Senior Secured Notes.

The Company began utilizing its ATM facility in November 2020. Since inception to March 31, 2023, the Company sold 11,420,579 shares of Common Stock which generated net cash proceeds of approximately $40,656, net of commissions and other transaction costs of $2,130. For the three months ended March 31, 2023, the Company sold 1,078,622 shares of Common Stock which provided net proceeds of approximately $916, net of commissions and other transaction costs of $77. This ATM facility has approximately $32,422 worth of shares of Common Stock available at March 31, 2023. The Company is subject to the SEC general instructions of Form S-3 known as the "baby shelf rules." Under these instructions, the amount of funds the Company can raise through primary public offerings of securities in any 12-month period using its registration statement on Form S-3 is limited to one-third of the aggregate market value of the shares of the Company’s Common Stock held by non-affiliates. Therefore, the Company will be limited in the amount of proceeds it is able to raise by selling shares of its Common Stock using its Form S-3, including under the ATM facility and the Lincoln Park Purchase Agreement, until such time as its public float exceeds $75 million.

While the Company’s ability to execute its business objectives and achieve profitability over the longer term cannot be assured, the Company's on-going business, existing cash, expense management activities, including, but not limited to potentially ceasing nearly all R&D activities, as well as access to the equity capital markets, including through its ATM facility and under the Lincoln Park Purchase Agreement, provide near term liquidity for the Company to fund its operating needs, including making the principal and interest payments on the 12.5% Senior Secured Notes, for at least the next twelve months as it continues to execute its business strategy. See Note 13, 12.5% Senior Secured Notes and Loans Payable for details.