Company: HCWB
Filing Date: 2025-04-07
Form Type: S-1
Source: 0001193125-25-073723
Chunk: 19

Company: HCW Biologics Inc.
Filing Date: 2025-04-07
Form: S-1
Chunk 19
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, management of clinical, preclinical, and manufacturing activities, regulatory approval in multiple
jurisdictions, establishing manufacturing supply, including commercial manufacturing supply, and require us to build a commercial organization and make substantial investment and significant marketing efforts before we generate any revenue from
product sales. We are not permitted to market or promote any of our product candidates before we receive regulatory approval from the FDA or comparable foreign regulatory authorities, and we may never receive such regulatory approval for any of our
product candidates.

If we do not successfully execute or address these matters in a timely manner or at all, we could experience significant delays or an
inability to successfully develop and commercialize our product candidates, which would materially adversely affect our business, financial condition, and results of operations.

A key element of our strategy is to enter into out-licensingarrangements for certain rights to internally developed molecules that we do not intend to develop into lead product candidates on our own or together with co-developmentpartners. We may not be able to identify licensees, which could lower any return on our investments and increase our need for external funding.

Since we have already generated over 50 immunotherapeutic molecules,
and plan to develop additional molecules, through our immunotherapy platform technology, our strategy includes funding operations in part through revenues derived from out-licensing molecules that are outside
our oncological and anti-aging focus to third parties. Despite our efforts, we may be unable to enter into such licensing agreements. Supporting diligence activities conducted by potential licensors and negotiating the financial and other terms of a
license agreement are long and complex processes with uncertain results, and we may fail to derive any revenues from these activities. If we fail to successfully out-license to third parties internally
developed molecules that are not part of the Company’s in-house clinical development programs, our revenues and return on our research and development activities would be negatively affected and we could
be required to seek additional funding.

The success of our business development efforts, including license agreements, depends on our ability to realize the anticipate benefits of these transactions and is subject to numerous risks and uncertainties, many of which are outside of our control.

Our potential licensors intend to develop alternative products or pursue alternative technologies either on their own or in collaboration with
others, potentially resulting in our receiving no future milestone or royalty payments under any such licenses. We enter exclusive worldwide license arrangements pursuant to which licensors will develop certain immunotherapy products under which we
may earn upfront license fees, additional milestone or royalty payments, but there can be no assurance that