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Latest 10-Q filed 11/13/2025 · Compared against 8/13/2025
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ITEM 1A RISK FACTORS
FOR INFORMATION REGARDING FACTORS THAT COULD AFFECT THE COMPANYS RESULTS OF OPERATIONS, FINANCIAL CONDITION AND LIQUIDITY, SEE THE RISK FACTORS DISCUSSED IN OUR ANNUAL REPORT ON FORM 10-K FOR THE YEAR ENDED DECEMBER 31, 2024, UNDER ITEM 1A RISK FACTORS. ADDITIONS TO THE RISK FACTORS DISCLOSED UNDER ITEM 1A RISK FACTORS OF THE ANNUAL REPORT INCLUDE:
our risk of imminent bankruptcy;
we need to obtain substantial funding immediately in order to continue operations and our exploration of strategic alternatives;
our suppliers may choose to stop working on programs, change the terms of contracts or terminate contracts for key programs;
our ability to maintain an adequate supply of clinical drug product to complete our ongoing and planned clinical trials;
our suppliers may face challenges due to increased tariffs, geopolitical tensions, regulatory changes, and dependencies in the global supply chain, which could lead to higher costs for imported goods, delays in supply, or interruptions in deliveries;
our suppliers may change the terms of contracts with the company;
our risk of not being able to meet the continued listing requirements of the TSX and the risk of not being able to meet the listing requirements of Nasdaq as part of the Company's plan to relist on Nasdaq; and
one of our contract research organizations represented 375% of our accounts payable as of JuneSeptember 30, 2025. Subsequent to JuneSeptember 30, 2025, we paid $1.90.5 million and the amount owed as of the date of this filing is $1.64 million.
GOING CONCERN RISK
The Company's financial statements have been prepared on a going concern basis under which the Company is considered to be able to realize its assets and satisfy its liabilities in the ordinary course of business. However, as of the date of this filing, management does not believe that the Companys cash and cash equivalents balance is sufficient to meet its general working capital requirements and contractual obligations for the next 12 months. The Company does not have sufficient cash to fund operations and relies on advances made by Hanmi therefor. The Company's future operations are dependent upon the identification and successful completion of equity or debt financing and the achievement of profitable operations at an indeterminate time in the future. There can be no assurances that the Company will be successful in completing additional equity or debt financing or in achieving profitability, or that such additional equity or debt financing will be completed on terms satisfactory to the Company and would be sufficient to satisfy any liquidity concerns related to the Companys ability to continue as a going concern. Certain adverse conditions and material uncertainties cast doubt upon the ability of the Company to continue as a going concern without a significant restructuring and/or financing. These include:
the Company has cash-on-hand of approximately $1.62.2 million as at the date of this filing;
the Company has a working capital deficiency (excess current liabilities over current assets);
the Company currently has had no material sales of marketed products and no material sources of cash other than financings, and there can be no assurance as to the Companys ability to maintain or obtain sufficient financing sources for operations or to meet future obligations.
uncertainty regarding the Company's ability to raise additional capital, which raises significubstantial doubt about its ability to continue as a going concern without substantial financing.
Due to these adverse conditions and material uncertainties, the use of the going concern assumption in the preparation of the Companys financial statements may not be appropriate. This could result in material adjustments to the amounts and classifications of assets and liabilities in the Company's financial statements should the Company fail to continue as a going concern. The financial
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statements do not give effect to any adjustments relating to the carrying values and classification of assets and liabilities that would be necessary should it be unable to continue as a going concern. If the Company is unable to continue as a going concern, it may be forced to seek relief under applicable bankruptcy and insolvency legislation, which may negatively affect the price and volatility of the Common Shares and any investment in such shares could suffer a significant decline or total loss in value and would subject the Company to additional risks related to such proceedings.
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