Form 8-K
8-K — HCW Biologics Inc.
Accession: 0001493152-26-025336
Filed: 2026-05-27
Period: 2026-05-21
CIK: 0001828673
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Termination of a Material Definitive Agreement
Item: Financial Statements and Exhibits
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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): May 21, 2026
HCW
Biologics Inc.
(Exact
name of Registrant as Specified in Its Charter)
Delaware
001-40591
82-5024477
(State
or Other Jurisdiction
of
Incorporation)
(Commission
File
Number)
(IRS
Employer
Identification
No.)
2929
N. Commerce Parkway
Miramar,
Florida
33025
(Address
of Principal Executive Offices)
(Zip
Code)
Registrant’s
Telephone Number, Including Area Code: 954 842-2024
Not
Applicable
(Former
Name or Former Address, if Changed Since Last Report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
☐
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
Trading
Symbol(s)
Name
of each exchange on which registered
Common
Stock, par value $0.0001 per share
HCWB
The
Nasdaq Stock Market LLC
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging
growth company ☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Item
1.02 Termination of a Material Definitive Agreement.
On
May 27, 2026, HCW Biologics Inc. (the “Company”) issued a press release announcing that on May 21, 2026, the Company elected
to exercise its option to terminate the exclusive worldwide license agreement with Wugen Inc. (the “License”) for ex
vivo rights to the Company’s molecules HCW9201 and HCW9206. The termination was made pursuant to Section 1(b) of
the 12-month suspension letter agreement (“Suspension Letter Agreement”) the parties entered into on May 30, 2025.
Pursuant to Section 1(b) of the Suspension Letter Agreement, the Company had the right to terminate the License during the 12-month
suspension period if the Company entered into a letter of intent with a third party to license the ex vivo rights
for either HCW9201 and/or HCW9206 prior to the end of the suspension period.
A
copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The
information furnished in this Current Report on Form 8-K, including the exhibit hereto, shall not be deemed “filed” for purposes
of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any
filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference
in such a filing.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits
Exhibit
No.
Description
99.1
Press release dated May 27, 2026.
104
Cover
Page Interactive Data File (embedded within the Inline XBRL document).
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
HCW BIOLOGICS INC.
Date:
May
27, 2026
By:
/s/
Hing C. Wong
Hing
C. Wong
Founder
and Chief Executive Officer
EX-99.1
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EXHIBIT
99.1
HCW
Biologics Exercised Option to Regain Full Rights for Two Commercial-Ready Reagents from Wugen
Positions
the Company to participate in fast-growing, multi-billion-dollar CAR-T immunotherapy market
Recently
published data suggest that HCW9206 may reduce CAR-T production costs and improve therapeutic efficacies, with the potential to support
curative outcomes
Company
plans to commercialize the reagents through corporate partners focused on CAR-T and NK-cell therapies, including developers and manufacturers
MIRAMAR,
Fla., May 27th, 2026 (GLOBE NEWSWIRE) — HCW Biologics Inc. (the “Company”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical
company developing first-in-class fusion immunotherapeutics for autoimmune diseases, cancer, and senescence-associated dysplasia, today
announced that it has exercised its option to regain full ex vivo rights to HCW9206 and HCW9201, two commercial-ready compounds as reagents,
from its licensee, Wugen Inc. Wugen held exclusive worldwide rights to these two compounds for ex vivo, cell-based therapy applications.
The Company acquired these rights for no cost and retained the nonrefundable upfront license fee, including 2.2 million shares of Wugen
common stock.
Recent
data published in the high-impact, peer-reviewed journal, Science Advances, indicate that HCW9206, the Company’s proprietary,
commercial-ready multi-cytokine fusion protein reagent, may offer a novel, cost-effective approach to producing CAR-T cells with enhanced
function for immunotherapy (see link number 1 for full article below). As a first-in-class cytokine-scaffold platform, HCW9206 has the
potential to improve manufacturing efficiency while supporting the development of more potent CAR-T therapies at lower costs.
HCW9206
has the advantage of generating a CAR-T population which is markedly enriched for long-lived T-memory stem (“Tscm”) cells,
which are rare, highly proliferative, and self-renewing cells. Results from a recent, third-party clinical trial in patients with blood
cancer demonstrated that a more defined CAR-T product, enriched with Tscm, persists longer in the body and achieves complete remissions
at low doses—without the need for chemotherapy pre-conditioning (see link number 2 to full article below). The Company believes
that these results support its perspective that utilizing HCW9206 as part of a manufacturing process may be broadly applicable to increase
persistence and functionality of CAR-T therapy.
Dr.
Hing C. Wong, the Company’s Founder and CEO, stated, “We are excited to regain the full commercial rights for ex vivo use
of HCW9206 and HCW9201. We have a great opportunity to develop Tscm-based CAR-T approaches to benefit patients with blood cancer,
solid tumors or autoimmune diseases, through partnerships with larger companies who are focused on CAR-T therapies.”
Dr.
Wong continued, “HCW9206 is a novel compound that allows a single molecule to deliver synergistic signals from three immune-stimulating
cytokines. It is versatile and has demonstrated activity in generating large quantities of memory-like NK cells for cancer cell therapy
in a GMP manufacturing scale (see link number 3 to full article below). We have also found that it may enhance CAR-T manufacturing as
a promising new reagent with the potential to improve production processes. In addition, experimental models show that HCW9206 may improve
the function and persistence of CAR-T cells following adoptive transfer for treatment of infectious disease and cancer, a goal the industry
has been pursuing for the past decade.”
Links
for Articles Referenced in Press Release:
(1)
Cole EB, …Wong HC, Goldstein H. IL-7/IL-15/IL-21 cytokine-fusion scaffold generates highly functional CAR T cells enriched in
long-lived T memory stem cells. Sci Adv. 2026 Mar 13;12(11):eaec2632. doi: 10.1126/sciadv.aec2632. Epub 2026 Mar 13.
(2)
Gattinoni L, et al. Distinct in vivo dynamics of donor-derived stem cell memory CAR T cells post-allogeneic HSCT relapse. Cell. 2026
Apr 30:S0092-8674(26)00383-1. doi: 10.1016/j.cell.2026.03.047.
(3)
Shrestha N, …Rhode PR, Wong HC. A “Prime and Expand” strategy using the multifunctional fusion proteins to generate
memory-like NK cells for cell therapy. Cancer Immunol Immunother. 2024 Jul 3;73(9):179. doi: 10.1007/s00262-024-03765-8.
About
HCW Biologics:
HCW
Biologics Inc. (the “Company”) (NASDAQ: HCWB) is a clinical-stage biopharmaceutical company developing transformative fusion
immunotherapeutics to treat diseases promoted by chronic inflammation, including autoimmune diseases, cancer, and senescence-associated
dysplasia. The Company’s immunotherapeutics represent a new class of drugs that it believes have the potential to fundamentally
change the treatment of proinflammatory and senescence-associated diseases and conditions that are promoted by chronic inflammation —and
in doing so, improve patients’ quality of life and possibly extend longevity. A key aspect of the Company’s clinical development
and financing strategy is to focus on its business development programs. See the Company Pipeline at https://hcwbiologics.com/pipeline/
Forward
Looking Statements:
Statements
in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. These
statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking
statements contained in this press release may be identified by the use of words such as “anticipate,” “expect,”
“believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,”
“forecast” or other similar words and include, the ability and efficacy of HCW9206 for generating CAR-T’s for immune
cell therapy with increased persistence and functionality at a lower cost; the ability of HCW9206 preclinical studies to translate into
human trials to activate long-lived T-memory stem cells (“Tscm”) cells in patients; the ability of HCW9206 to improve long-term
survival of disease- specific CAR-Ts following adoptive transfer and enable sustained suppression of malignancies, chronic infections
and autoimmune diseases; the availability for a license and supply HCW9206 for commercial use for certain indications. Forward- looking
statements are based on the Company’s current expectations and are subject to inherent uncertainties, risks and assumptions that
are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove
to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties that are
described in the section titled “Risk Factors” in the annual report on Form 10-K filed with the United States Securities
and Exchange Commission (the “SEC”) on March 31, 2026, the quarterly report on Form 10-Q filed with the SEC on May 14, 2026,
and in other filings filed from time to time with the SEC.
Company
Contact:
Peter
Rhode, PhD.
Chief
Scientific Officer and Vice President Clinical Operations
HCW
Biologics Inc.
peterrhode@hcwbiologics.com
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