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Note 3 - Going Concern and Management's Plans
9 Months Ended
Sep. 30, 2025
Notes to Financial Statements  
Liquidity Disclosures [Text Block]

Note 3 – Going Concern and Management’s Plans

 

We are subject to risks common to companies in the biotechnology industry, including but not limited to the need for additional capital, risks of failure of preclinical and clinical studies, the need to obtain marketing approval and reimbursement for any drug product candidate that we may identify and develop, the need to successfully commercialize and gain market acceptance of our product candidates, dependence on key personnel, protection of proprietary technology, compliance with government regulations, development of technological innovations by competitors, and risks associated with our international operations in Taiwan and activities abroad, including but not limited to having foreign suppliers, manufacturers, and clinical sites in support of our development activities.

 

With the exception of certain non-recurring items such as gain on debt extinguishment or change in fair value of financial instruments, we have incurred net losses since inception. Our net loss was $28.1 million and $42.8 million, respectively, for the three and nine months ended September 30, 2025. Our net loss was $2.7 million and $4.6 million, respectively, for the three and nine months ended September 30, 2024. We expect to continue to incur operating losses for at least the next several years. As of September 30, 2025, we had an accumulated deficit of $889.4 million. Our future success is dependent on our ability to fund and develop our product candidates, and ultimately upon our ability to attain profitable operations. We have devoted substantially all of our financial resources and efforts to research and development expense and general and administrative expense to support such research and development. Net losses and negative cash flows have had, and will continue to have, an adverse effect on our stockholders’ equity and working capital, and accordingly, our ability to execute our future operating plans.

 

In July 2025, we entered into a Common Stock Purchase Agreement, or the 2025 ELOC Purchase Agreement, establishing an equity line of credit with the purchaser, or the Purchaser, whereby we have the right, but not the obligation, to sell to the Purchaser, and the Purchaser is obligated to purchase, up to $500 million of newly issued shares of our common stock. The Purchaser is also a holder of the Company's Series C Preferred Stock and Series D Preferred Stock as well as a holder of certain of our convertible notes payable.  On October 23, 2025, we and Seven Knots entered into an amendment, or the ELOC Amendment, to the 2025 ELOC Purchase Agreement, pursuant to which the parties agreed to, among other things, expand the definition of “Eligible Market” to include over-the-counter markets, including The OTCID Basic Market. On October 24, 2025, pursuant to the 2025 ELOC Purchase Agreement, we filed a Form S-1 Registration Statement under the Securities Act of 1933 with the U.S. Securities and Exchange Commission (the “SEC”)  registering up to 555,555,556 shares of common stock under the 2025 ELOC Purchase Agreement and (ii) up to 166,687,215 shares of common stock, issuable upon the conversion of the outstanding unpaid principal balance, together with all accrued and unpaid interest, if any, of the convertible promissory note, issued to Seven Knots as consideration for it entering into the 2025 ELOC Purchase Agreement.  

 

In June 2024, we entered into a Common Stock Purchase Agreement, or the 2024 ELOC Purchase Agreement, establishing an equity line of credit with the purchaser, or the Purchaser, whereby we have the right, but not the obligation, to sell to the Purchaser, and the Purchaser is obligated to purchase, up to $35 million of newly issued shares of our common stock. The Purchaser is also a holder of the Company's Series C Preferred Stock and Series D Preferred Stock as well as a holder of certain of our convertible notes payable.  For the three months ended September 30, 2025, we sold 21.1 million shares of Common Stock under the 2024 ELOC Purchase Agreement for net proceeds of $13.4 million. 

 

As of September 30, 2025, we had cash and cash equivalents of $0.2 million and current liabilities of $21.9 million. During July and August 2025, we sold 21.1 million shares of common stock for net proceeds of $13.4 million following mandatory redemption payments on our preferred stock (See the section titled, “Note 15 - Mezzanine Equity and Stockholders' Equity - Common Stock Purchase Agreement” for further details). We believe that we have sufficient resources available to fund our business operations through December 2025. We do not have sufficient cash and cash equivalents as of the date of this Quarterly Report on Form 10-Q to support our operations for at least the 12 months following the date that the financial statements are issued. These conditions raise substantial doubt about our ability to continue as a going concern.

 

To alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, management plans to secure additional capital, potentially through a combination of public or private securities offerings, convertible debt financings, and/or strategic transactions, including potential licensing arrangements, alliances, and drug product collaborations focused on specified geographic markets; however, none of these alternatives are committed at this time. There can be no assurance that we will be successful in obtaining sufficient funding on terms acceptable to us to fund continuing operations, if at all, or identify and enter into any strategic transactions that will provide the capital that we will require. If we fail to raise sufficient capital, we potentially could be forced to limit or cease our development activities, as well as modify or cease our operations, either of which would have a material adverse effect on our business, financial condition, and results of operations. 

 

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business, and do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern.