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Going Concern and Management's Plans
12 Months Ended
Dec. 31, 2022
Cash and Cash Equivalents [Abstract]  
Going Concern and Management's Plans

Note 2. Going Concern and Management’s Plans

The Company had a net loss of $24.1 million during 2022 and has an accumulated deficit of $237.4 million at December 31, 2022 resulting from having incurred losses since its inception. The Company had $14.6 million of cash and cash equivalents on hand at December 31, 2022 and used $20.8 million of cash in its operating activities during 2022.

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

The Company expects to continue incurring losses for the foreseeable future and will be required to raise additional capital to complete its clinical trials, pursue product development initiatives, obtain regulatory approval and penetrate markets for the sale of its products. In March 2022, the Company completed a public offering of its securities and raised $13.8 million in net proceeds. Management believes that the Company will continue to have access to capital resources through possible public or private equity offerings, debt financings, corporate collaborations or other means. However, access to such capital resources is uncertain and not assured. In December 2022, the Company entered into a Securities Purchase Agreement for up to $60.0 million in additional funding if certain conditions are met. Due to the contingent nature of these funds, accounting principles generally accepted in the United States of America (GAAP) requires the Company to exclude them from its going concern analysis. If the Company is unable to secure additional capital, it may be required to curtail its clinical trials and development of new products and take additional measures to reduce expenses in order to conserve its cash in amounts sufficient to sustain operations and meet its obligations. These measures could cause significant delays in the Company’s efforts to complete its clinical trials and commercialize its products, which are critical to the realization of its business plan and the future operations of the Company.

Management believes that the Company does not have sufficient capital resources to sustain operations through at least the next twelve months from the date of this filing. Additionally, in view of the Company’s expectation to incur significant losses for the foreseeable future it will be required to raise additional capital resources in order to fund its operations, although the availability of, and the Company’s access to such resources is not assured. Accordingly, management believes that there is substantial doubt regarding the Company’s ability to continue operating as a going concern through at least the next twelve months from the date of this filing.