Current Report · Items 1.01, 7.01, 9.01 · 8-K
HCW Biologics Inc.
HCWBNASDAQEQUITYCurrent
Entry into a Material Definitive Agreement · Regulation FD Disclosure
Item 1.01 Entry into a Material Definitive Agreement. On 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 molec…
Filed Sep 8, 2026Accepted Sep 8, 2026, 9:00 AM EDTCIK 1828673Accession 0001493152-26-041716
Company context
HCW Biologics Inc. (“HCW Biologics” or the “Company”) is a clinical-stage biopharmaceutical company developing transformative fusion immunotherapeutics to support or treat diseases promoted by chronic inflammation. We have created novel compounds that represent a new class of drugs that we believe have the potential to fundamentally change the treatment of autoimmune disorders and other proinflammatory diseases, cancer and senescence-associated dysplasia. Among other things, we have begun commercialization of certain commercial-ready proprietary compounds for use as reagents in the production of immunotherapeutics for the treatment of infectious diseases and cancer. We want our products to improve patients’ healthspan as well as their quality of life, and possibly extend longevity.
Current securities
Disclosure sections
Items 1.01, 7.01, 9.01Select an item to read the extracted section. The as-filed document remains the primary evidence.
Item 1.01Item 1.01 - Entry into Material Agreement
Item
1.01 Entry into a Material Definitive Agreement.
On
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.
In
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 7.01Item 7.01 - Regulation FD Disclosure
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.
Filed exhibits (1)
EX-99.1 (by filename) ex99-1.htmEX-99.1
2
ex99-1.htm
EX-99.1
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 t…
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