HCW Biologics Inc.
Filed Jun 8, 2026.
View on SEC.govAbout this filing
A company's registration of shares for sale to the public, often for a first offering. It describes the business, its risks and how the company plans to use the money.
period unavailable · Filed Jun 8, 2026
Contents
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This prospectus and the information incorporated herein by reference contain forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations, and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, and other future conditions. This includes, without limitation, statements regarding the financial position and the plans and objectives of management for our future operations. Such statements can be identified by the fact that they do not relate strictly to historical or current facts. When used in this prospectus, words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “strive,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements in this prospectus and in any document incorporated by reference in this prospectus, including our Annual Report for the year ended December 31, 2025, filed on Form 10-K on March 31, 2026 (the “Annual Report”) and our Quarterly Report for the three month period ended March 31, 2026, filed on Form 10-Q on May 14, 2026, may include, for example, statements about:
| ● | management’s going concern assessment; |
| ● | the occurrence of any event, change or other circumstances, including the outcome of any legal proceedings that may be instituted against us; |
| ● | financial performance and the ability to remain compliant with the continued listing requirements of Nasdaq, maintain the listing of our securities on Nasdaq, and the potential liquidity and trading of our securities; |
| ● | the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements and the risk of disruption to our current plans and operations; |
| ● | our ability to obtain funding for our operations, including funding necessary to develop and commercialize our drug candidates; |
| ● | timing, costs and outcome of regulatory review, and impact on our ability to receive FDA clearance for clinical trials; |
| ● | the ability to secure clinical sites, enroll patients, and initiate clinical trials; |
| ● | number of trials needed to obtain clinical approval; |
| ● | the ability of our clinical trials to demonstrate safety and efficacy of our drug candidates, and other positive results; |
| ● | the success, cost and timing of our development activities, preclinical studies and clinical trials; |
| ● | the timing and focus of our future clinical trials, and the reporting of data from those trials; |
| ● | our plans relating to commercializing our drug candidates, if approved; |
| ● | our plans and ability to establish sales, marketing and distribution infrastructure to commercialize any drug candidates for which we obtain approval; |
| ● | our ability to attract and retain key scientific and clinical personnel; |
| ● | our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; |
| ● | our reliance on third parties to conduct clinical trials of our drug candidates, and for the manufacture of our drug candidates for preclinical studies and clinical trials; |
| ● | our ability to establish our own manufacturing facilities domestically; |
| ● | our ability to expand our drug candidates into additional indications and patient populations; |
| ● | the success of competing therapies that are or may become available; |
| ● | the beneficial characteristics, safety and efficacy of our drug candidates; |
| ● | political and regulatory developments in the United States and other jurisdictions; |
| ● | our ability to obtain and maintain regulatory approval of our drug candidates, and any related restrictions, limitations and/or warnings in the label of any approved drug candidate; |
| ● | our plans relating to the further development and manufacturing of our drug candidates, including additional indications for which we may pursue; |
| ● | cost of maintaining, expanding, and enforcing our intellectual property rights; |
| ● | our plans and ability to obtain or protect intellectual property rights; |
| ● | the scope of protection we are able to establish and maintain for intellectual property rights covering our drug candidates and technology; |
| ● | potential claims relating to our intellectual property; |
| ● | impact of litigation, regulatory inquiries, or investigations, as well as cost to indemnify our officers and directors against third-party claims related to our patents and other intellectual property; |
| ● | cost and timing of buildout of our new headquarters, including a biologics manufacturing facility, including risks of balances due to general contractor and subcontractors, cost overruns and delays, and ability to obtain additional funding required to complete the project; |
| ● | our ability to enter out-license agreements for the development and commercialization of the Company’s non-core assets; |
| ● | cost and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive regulatory approval; and |
| ● | other factors disclosed under the section entitled “Risk Factors” in this prospectus. |
Forward-looking statements are based on management’s current expectations, estimates, forecasts and projections about our business and the industry in which we operate, and management’s beliefs and assumptions are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control, including those described in the section titled “Risk Factors” and elsewhere in this prospectus and the documents incorporated by reference into this prospectus.
Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Accordingly, you should not place undue reliance on forward-looking statements as predictions of future events. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this prospectus to conform these statements to actual results or to changes in our expectations, except as required by law.
You should read this prospectus, the documents incorporated by reference into this prospectus, any free writing prospectus and the documents that we reference in this prospectus and have filed with the SEC, as exhibits to the registration statement of which this prospectus is a part with the understanding that our actual future results, levels of activity, performance and events and circumstances may be materially different from what we expect.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.