(3) Going Concern

The Company’s operations to date have focused on commercializing products, developing and acquiring technology and assets, business planning, raising capital and organization and staffing. The Company has incurred recurring losses and negative cash flows from operations since inception and has an accumulated deficit of $421.1 million as of June 30, 2026. The Company anticipates incurring additional losses until such time, if ever, it can generate sufficient revenue from its products to cover its expenses.

Management has evaluated the Company's ability to continue as a going concern for the twelve-month period following the issuance date of these consolidated financial statements. The Company’s Credit Agreement with Perceptive (see Note 6, "Long-Term Debt") requires compliance with certain financial covenants, including minimum revenue and liquidity thresholds. Although the Company was in compliance with these covenants as of June 30, 2026, management's current forecasts indicate it is probable that the Company will not achieve the minimum revenue threshold required under the Credit Agreement during the twelve-month period following the issuance of these consolidated financial statements. If the Company fails to satisfy the applicable covenant requirements and does not obtain a waiver or amendment from Perceptive, the lender could declare an event of default and accelerate repayment of all outstanding principal and accrued interest under the Credit Agreement. The Company does not expect to have sufficient liquidity to repay such obligations if repayment were accelerated.

In addition, projected compliance with the liquidity covenant is sensitive to changes in the assumptions of our operating forecast. The Company’s ability to maintain compliance with the liquidity covenant is dependent on its ability to grow revenue and manage its costs. The Company’s current operating plan includes measures to reduce our operating expenses. Inability to do so may result in an event of default in future periods.

These conditions and events raise substantial doubt about the Company's ability to continue as a going concern within one year after the date these consolidated financial statements are issued.

To address these conditions, management is evaluating and pursuing various actions, including seeking a waiver of, or amendment to, the applicable covenant requirements under the Credit Agreement, pursuing strategic initiatives intended to increase revenues, and implementing measures designed to reduce operating expenses. While management believes that such measures can be implemented, such actions would not eliminate the risk of noncompliance with the revenue covenant. In addition, the Company's ability to achieve the level of revenue growth necessary to comply with the covenant is dependent on future operating performance and other factors that are not entirely within management's control. Accordingly, management has concluded that substantial doubt exists about the Company's ability to continue as a going concern within one year after the date these consolidated financial statements are issued.

The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty.