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Going Concern and Management’s Plans
3 Months Ended
Mar. 31, 2026
Going Concern and Management’s Plans [Abstract]  
Going Concern and Management’s Plans

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 March 31, 2026, the Company had cash of approximately $3.7 million, a working capital surplus of approximately $1.3 million and an accumulated deficit of approximately $135.4 million. During the three months ended March 31, 2026, the Company used approximately $2.1 million in cash for operating activities. In addition, as of May 11, 2026, the Company’s cash balance was approximately $4.1 million.

 

The Company successfully closed a Series D financing and a Series E financing in September 2025 and October 2025, respectively. These financings provided the Company with additional cash flow to support near-term operations. While these capital raises may enable the Company to sustain current operations and meet existing obligations, 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 involvement with 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. 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.