Note 2 — Going Concern and Management’s Plans

The Company’s operating activities to date have been devoted to seeking licenses, engaging in research and development activities, potential asset and business acquisitions, expenditures associated with the previously planned commercial launch of ENTADFI, and the commercialization of Proclarix.

The Company has incurred substantial operating losses since inception and expects to continue to incur significant operating losses for the foreseeable future.

As of June 30, 2026, the Company had cash of approximately $5.9 million, a working capital surplus of approximately $3.6 million and an accumulated deficit of approximately $138.3 million. During the six months ended June 30, 2026, the Company used approximately $4.0 million in cash for operating activities. In addition, as of August 10, 2026, the Company’s cash balance was approximately $5.4 million.

The Company continues to generate recurring net operating losses and has not yet established sustained positive cash flows to support its strategic growth initiatives, which includes the commercialization of Proclarix, and participation in strategic transactions and investments, including its proposed acquisition of Realbotix. These factors raise substantial doubt about the Company’s ability to continue as a going concern within one year from the date of the issuance of these consolidated financial statements.

Management’s plans for funding the Company’s operations include advancing its strategic initiatives, including commercialization efforts related to Proclarix, and execution of recent and potential strategic transactions. Subsequent to June 30, 2026, on July 28, 2026, the Company entered into a securities purchase agreement pursuant to which it issued Series F Preferred Stock for aggregate gross proceeds of approximately $30.2 million and received net cash proceeds of approximately $0.25 million. Management has considered the impact of this financing, together with its ongoing efforts to obtain additional capital and improve operating cash flows, in evaluating the Company's ability to continue as a going concern. While the transaction provided additional liquidity, management believes that the Company will continue to require additional financing and/or improved operating results to fund its operations and satisfy its obligations as they become due.

Management also intends to pursue additional equity or debt financing to support operations and strategic initiatives. However, there are currently no committed sources of financing, and there is no assurance that additional funding will be available on favorable terms, if at all. This uncertainty raises significant concern about the Company’s ability to sustain operations and execute its strategic initiatives. If additional capital is not secured, the Company may need to curtail clinical trials, development, and commercialization efforts, and take further measures to reduce expenses to conserve cash.

Because of historical and expected operating losses and net operating cash flow deficits, there is substantial doubt about the Company’s ability to continue as a going concern for one year from the issuance of the unaudited condensed consolidated financial statements, which is not alleviated by management’s plans. The unaudited condensed consolidated financial statements have been prepared under the going concern basis of accounting. These unaudited condensed consolidated financial statements do not include any adjustments that might be necessary from the outcome of this uncertainty.