Form 8-K

8-K — HCW Biologics Inc.

Accession: 0001493152-26-041716

Filed: 2026-09-08

Period: 2026-09-04

CIK: 0001828673

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Entry into a Material Definitive Agreement

Item: Regulation FD Disclosure

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): September 4, 2026

HCW

Biologics Inc.

(Exact

name of Registrant as Specified in Its Charter)

Delaware

001-40591

82-5024477

(State

or Other Jurisdiction

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

(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 ☒

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

1.01 Entry into a Material Definitive Agreement.

September 4, 2026, HCW Biologics Inc. (the “Company”) entered into an Exclusive Distribution Agreement (the “Distribution

Agreement” or “Agreement”) with Akron Biotech (“Akron”), a leading manufacturer of ancillary materials

and a contract development and manufacturing organization for the distribution of the Company’s commercial-ready molecule, HCW11-006,

for use as a reagent in cell therapy manufacturing and other ex vivo applications, but not for use in injectable

therapies (the “Product”), throughout the world, excluding the People’s Republic of China, for a term of five

years from the closing date unless terminated earlier for cause or by the Company’s exercise of its right to terminate for

convenience. If the Agreement is terminated by the Company for convenience, under the terms of the Distribution Agreement, the Company

has committed to continue to supply the Product to support existing Akron customers, in addition to other provisions, to ensure a seamless

transition for customers.

connection with the Distribution Agreement, the parties will enter into a Material Transfer Agreement to permit Akron

to perform further due diligence and evaluate the Product. The closing is subject to the satisfactory completion

of due diligence and product testing but will occur no later than November 30, 2026. Under the Distribution Agreement, the parties

also agreed to negotiate in good faith to finalize and execute a Supply Agreement within 60 days of the closing date, under which

the Company will (assuming the closing occurs) receive advance payments of $200,000 at closing, $100,000 within 30 days of

execution of the Supply Agreement, and $100,000 on each of the first and second anniversaries of the closing date. In addition, the

Distribution Agreement provides that Akron will make quarterly payments for the Company’s technical support, as needed.

The

foregoing description of the Distribution Agreement is qualified in its entirety by reference to the full text of the Distribution

Agreement, a copy of which will be filed as an exhibit to a subsequent filing, if applicable.

Item 7.01 Regulation FD Disclosure.

On September 8, 2026, HCW Biologics Inc. issued

a press release announcing its entry into an Exclusive Distribution Agreement with Akron Biotech for the commercialization

and distribution of HCW11-006 for use as a reagent to support cell therapy manufacturing. 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 September 8, 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 hereunto duly authorized.

HCW BIOLOGICS INC.

Date:

September

8, 2026

By:

/s/

Hing C. Wong

Hing

C. Wong, Founder and Chief Executive Officer

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit

99.1

HCW

Biologics Entered an Exclusive Distribution Agreement with Akron Biotech to Commercialize HCW11-006 as Reagent Used to Support Production of

Highly Functional Human CAR-T Cells

Agreement

includes pre-payment commitments for product sales and distribution of the second-generation multi-cytokine-based

HCW11-006 for use as a reagent

Akron

is a leading supplier of critical ancillary materials and accessory molecules for clinical and commercial scale-up of cell,

gene and regenerative therapy products

HCW

Biologics supplies research and cGMP-grade HCW11-006 and Akron markets and distributes the reagent to its established network

of research institutions and commercial companies

Company

showed in studies that CAR-T cells manufactured using HCW11-006 as a reagent exhibited strong anti-tumor activity and enhanced

antiviral potency as well as potential for lowering the cost of production of CAR-T therapies

MIRAMAR,

Fla., September 8, 2026 (GLOBE NEWSWIRE) — HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ:

HCWB), a U.S.-based clinical-stage biopharmaceutical company focused on developing novel fusion immunotherapeutics to treat autoimmune

diseases, cancer, and senescence-associated dysplasia, announced today that the Company has entered into an Exclusive Distribution Agreement

with Akron Biotech (“Akron”), a leading manufacturer of ancillary materials and a contract development and manufacturing

organization for the cell, gene therapy, and regenerative medicine industries, for the commercialization of HCW11-006 for use

as a reagent to support a new method of producing highly functional human CAR-T cells for treating cancer, autoimmune disease, and infectious

diseases. Akron operates within a highly specialized global network of biomedical institutions, primarily catering to a customer base

of advanced therapy developers, biopharmaceutical companies, and research organizations. Akron manufactures and markets cGMP-compliant

ancillary materials (such as cytokines, media supplements, and plasmid DNA) necessary for bringing regenerative medicine from preclinical

stages to commercialization.

HCW11-006,

a first-in-class multi-cytokine fusion molecule built with our proprietary TRBC platform, enables production of more

potent CAR-T-based immunotherapies by generating a CAR-T population that is highly functional and markedly enriched for long-lived

T-memory stem cells (Tscm). Utilizing HCW11-006 as part of a manufacturing strategy may be broadly applicable to increase

persistence and functionality of CAR-Ts. Functional persistence of CAR-Ts is limited by conventional and costly manufacturing

methods utilizing anti-CD3/CD28 (αCD3/28)/IL-2 stimulation, which generates terminally differentiated and shorter-lived

CAR-Ts.

Utilizing

HCW11-006 as a reagent in the manufacture of CAR-Ts synergizes the effects of IL-7, IL-15 and IL-21 to promote the

generation of a CAR-T cell product with a diverse mix of T cell subsets that exhibit a combination of Tscm self-renewal

capacity and enhanced T cell effector function. In addition, as a reagent, HCW11-006 stimulates proliferation of

CD8+ T cells, particularly those within the Tscm subset. As a result, HCW11-006 was shown to generate CAR-Ts

without requiring αCD3/28/IL-2 activation that are highly enriched in long-lived Tscm and display

potent activity across distinct disease experimental models, namely, HIV-1 and B-cell leukemia.

preclinical studies, CAR-Ts manufactured using HCW11-006 were significantly superior compared to CAR-Ts manufactured using standard methods

employing αCD3/28/IL-2 reagents for CAR lentiviral transduction and subsequent expansion and persistence of highly active

human CAR-Ts. Clinical studies are planned to further confirm these findings. This research suggests that CAR-T cells produced

with HCW11-006 may be a more effective and longer-lasting CAR-T cell immunotherapy than conventional CAR-T cells produced

using αCD3/28/IL-2.

Dr.

Hing C. Wong, the Company’s Founder and Chief Executive Officer, stated, “We are thrilled that our first product, created

using our proprietary TRBC platform, has reached the commercialization stage. HCW11-006 is a novel compound that enables a single molecule

to deliver synergistic signals from three different immune-stimulatory cytokines. It is versatile and can be used as a novel reagent

to potentially replace the current industry-standard method that relies on αCD3/28/IL-2-based approaches. An approach that

employs HCW11-006 as a reagent is highly streamlined and may lower the cost of CAR-T manufacturing compared to existing approaches.

Equally important, based on experimental models, HCW11-006 has shown improvement in functional activities and persistence of CAR-Ts following

adoptive transfer, a goal the industry has been trying to achieve for the last decade.”

Dr.

Wong continued, “We are pleased to be entering into a partnership with Akron Biotech and their extensive network of customers who

include leading research institutions all over the world that will include the use of CAR-T treatments produced using HCW11-006 as a

reagent in clinical research and scale-up of commercialization. Recently, research laboratories and companies approached us directly

seeking supply of HCW11-006 to support their cell-based research and development for their novel therapies. We decided to seek a partnership

with a leading supplier to commercialize HCW11-006 for use as a reagent. We are excited to enter into this Distribution Agreement

to commercialize this application of HCW11-006 as a reagent with an established firm that specializes in manufacturing and distribution

of cell-based, gene and regenerative therapies.”

Article Referenced in Press Release:

Cole et al., “IL-7/IL-15/IL-21 cytokine-fusion

scaffold generates highly functional CAR T cells enriched in long-lived T memory stem cells,” Science Advances, Vol. 12, No.11,

13 Mar 2026

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. HCW Biologics is the leader in creation of multi-valent immunotherapeutics with a unique protein-based scaffold, without the

antibody Fc domain. 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, including its commercial-ready reagents to be used in the production

of immunotherapeutics for cancer and infectious diseases. To date, the Company has entered into two licensing agreements in which it

has licensed exclusive, worldwide rights for some of its proprietary molecules. 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 HCW11-006 for generating CAR-T cells for

immune cell therapy with increased persistence and functionality at a lower cost; the ability of HCW11-006 preclinical studies to translate

into human trials and demonstrate activation of long-lived T-memory stem cells (“Tscm”) in patients; the

ability of HCW11-006 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 of HCW11-006 for licensing, distribution and commercial

supply for certain indications; the anticipated commercialization of HCW11-006 as a reagent; the anticipated benefits, capabilities and

applications of HCW11-006 in supporting the manufacture of CAR-T cell therapies; the ability of HCW11-006 to generate CAR-T cells with

enhanced persistence, functionality or therapeutic activity; the ability of HCW11-006 to reduce or lower CAR-T manufacturing costs or

simplify manufacturing processes; the potential adoption, evaluation or use of HCW11-006 by research institutions, biopharmaceutical

companies and other customers; the anticipated benefits of the Company’s relationship with Akron Biotech, including Akron’s ability to

market and distribute HCW11-006; the expected demand for HCW11-006; and the ability of HCW11-006 to support the development, commercialization

or scale-up of cell-based therapies. 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 and in other filings

filed from time to time with the SEC.

Company

Contact:

Lee

Flowers

Senior

Vice President, Business Development

HCW

Biologics Inc.

LeeFlowers@hcwbiologics.com

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