LIQUIDITY AND GOING CONCERN |
6 Months Ended |
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Jun. 30, 2026 | |
| Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
| LIQUIDITY AND GOING CONCERN | NOTE 2 — LIQUIDITY AND GOING CONCERN
The accompanying unaudited condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As of June 30, 2026, the Company had an accumulated deficit of approximately $97,203,000. For the six months ended June 30, 2026, the Company incurred a loss from operations of approximately $4,367,000 and used approximately $3,515,000 of cash in operating activities. Although the Company had working capital of approximately $377,000 as of June 30, 2026, its operating activities continue to consume the majority of its cash resources.
The Company expects to continue to incur operating losses and negative cash flows as it advances its clinical development, regulatory and product development initiatives, including its ongoing clinical trial evaluating the Gen-3 HALO device for the treatment of insomnia, and pursues other strategic initiatives. Historically, the Company has funded its operations primarily through equity financings, including sales under its at-the-market offering program. The Company expects that additional capital will be required to fund its planned operations and strategic initiatives.
Management’s plans include continuing to pursue additional equity financing, expanding international revenue opportunities, advancing its clinical and regulatory programs, and managing operating expenditures. The successful execution of these plans is dependent upon a number of factors, many of which are outside the Company’s control, including favorable capital market conditions and the Company’s ability to obtain additional financing on acceptable terms, or at all.
After considering its plans, management concluded that the Company does not currently have sufficient cash and cash equivalents to fund its anticipated operating requirements for at least twelve months from the date these unaudited condensed consolidated financial statements are issued. Accordingly, management determined that its plans do not alleviate the substantial doubt about the Company’s ability to continue as a going concern. The accompanying unaudited condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
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