NOTE 3 – GOING CONCERN

The accompanying consolidated financial statements have been prepared in conformity with generally accepted accounting principles, which contemplate continuation of the Company as a going concern. The Company incurred a net loss of $5,074,000 for the eight months ended June 30, 2026 and used $383,000 of cash from operating activities during that period. In addition, the Company had an accumulated deficit at June 30, 2026.

The Company operates in an evolving regulatory environment governing regenerative biologics and human cells, tissues and cellular and tissue-based products (“HCT/Ps”). Certain products regulated by the United States Food and Drug Administration (“FDA”) as biological products under Section 351 of the Public Health Service Act require an approved biologics license application (“BLA”) before being marketed. In addition, certain states, including Florida, Tennessee and Georgia, have enacted legislation permitting the use of certain regenerative therapies under specified conditions, subject to applicable federal and state requirements. The Company believes its current operations are consistent with applicable regulatory requirements; however, it has not sought formal determinations from regulatory authorities regarding the classification or compliance status of its products and related activities. Accordingly, there can be no assurance that the FDA or other regulatory authorities will not adopt a different interpretation or challenge the Company’s compliance in the future, which could affect its ability to manufacture, distribute or sell certain products.

Management’s plans to address the Company’s operating and liquidity requirements include increasing revenues from existing operations, expanding domestic and international sales, developing additional products and commercial opportunities, and continuing its clinical research and development programs. The Company also expects to remain dependent on additional working capital through debt or equity financing to support its operations, product development and clinical studies. Its ability to obtain such financing may be affected by prevailing market conditions, the liquidity and market value of its common stock, available authorized shares and its limited assets available to secure borrowings. There can be no assurance that sufficient financing will be available on acceptable terms, or that the Company’s operating and commercialization strategies will achieve the anticipated results.

The Company’s ability to continue its operations is dependent upon successfully implementing its business and financing strategies, generating sufficient revenues to meet its operating obligations, and maintaining the ability to manufacture and commercialize its products in accordance with applicable regulatory requirements. If these objectives are not achieved, the Company may be required to reduce or defer expenditures, modify its operating plans, seek additional financing or pursue other strategic alternatives.

Based on the foregoing conditions and uncertainties, management has concluded that substantial doubt exists regarding the Company’s ability to continue as a going concern for the twelve months following the issuance of these consolidated financial statements. The accompanying consolidated financial statements do not include any adjustments to the carrying amounts or classification of assets and liabilities that might be necessary if the Company is unable to continue as a going concern.