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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
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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

Recent company filings

  1. Entry into a Material Definitive Agreement · Unregistered Sales of Equity Securities · Regulation FD Disclosure · Other EventsSep 24, 2026
  2. Regulation FD Disclosure · Other EventsSep 10, 2026
  3. PRER14A filingSep 9, 2026
  4. PRE 14A filingSep 8, 2026
  5. EFFECT filingAug 31, 2026

Disclosure sections

Items 1.01, 7.01, 9.01

Select 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.htm

EX-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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