Company: HCWB
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0000950170-25-046724
Chunk: 266

Company: HCW Biologics Inc.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1B
Chunk 266
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 implemented within the next year to determine if financing activities currently underway are sufficient mitigate the substantial doubt in our going concern analysis.  We have capital-raising activities planned for the first half of 2025, for which Maxim Group will act as our Placement Agent.  If the Company is not successful in raising additional capital through these activities, management may need to revise its business plan and reduce costs.  If such revisions are insufficient, the Company may have to curtail or cease operations.  

The accompanying audited financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above.  The Company believes that substantial doubt exists regarding its ability to continue as a going concern for at least 12 months from the date of issuance of the Company’s audited financial statements, without additional funding or financial support. After considering management’s plan for financing and funds raised that are probable to occur within one year, as well as that the Company expects to continue to incur losses from operations for the foreseeable future, management concluded that the substantial doubt that existed in its going concern analysis as of December 31, 2024 was not alleviated.  

Because of the numerous risks and uncertainties associated with the clinical development and commercialization of immunotherapeutics, we are unable to estimate the exact amount of capital requirements to pursue these activities. Our funding requirements will depend on many factors, including, but not limited to:

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•timing, progress, costs, and results of our ongoing preclinical studies and clinical trials of our immunotherapeutic products;

•costs, timing, and outcome of regulatory review of our product candidates;•number of trials required for regulatory approval;

•whether we enter into any cooperative, collaboration or co-development agreements and the terms of such agreements;

•whether we raise additional funding through bank loan facilities, other debt arrangements, out-licensing or joint ventures, cooperative agreements or strategic collaborations; 

•effect of competing technology and market developments;

•cost of maintaining, expanding, and enforcing our intellectual property rights; 

•impact of arbitration, litigation, regulatory inquiries, or investigations, as well as costs to indemnify our officers and directors against third-party claims related to our patents and other intellectual property:

•cost and timing of buildout of the Company’s new headquarters, including manufacturing for