HCW Biologics begins multi-center Phase 1 study of HCW9302

Rhea-AI Filing Summary

HCW Biologics Inc. reported that the first patient has been dosed in its company-sponsored, multi-center Phase 1 clinical trial of lead product candidate HCW9302 in patients with an autoimmune disorder. This marks an early clinical step for HCW9302 as the company moves from planning into active patient treatment under a formal trial setting. The update was shared through a press release dated November 18, 2025, which is furnished as an exhibit for informational purposes and not deemed filed for liability purposes under the securities laws.

Insights

Biotech clinical development analyst

HCW Biologics has begun dosing patients in a multi-center Phase 1 trial of HCW9302 for an autoimmune disorder.

The company states that the first patient has been dosed in a company-sponsored, multi-center Phase 1 clinical trial evaluating its lead product candidate, HCW9302, in patients with an autoimmune disorder. Moving into an active Phase 1 study typically focuses on assessing safety and tolerability in a controlled clinical setting, rather than demonstrating full efficacy.

The trial design is described only at a high level as multi-center and company-sponsored, without additional details on endpoints, size, or geography in this disclosure. The company communicated this development through a press release dated November 18, 2025, furnished as an exhibit for Regulation FD purposes, indicating it is treating this as a notable corporate update while not providing further quantitative or outcome-related data in this excerpt.

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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): November 17, 2025

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

(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 7.01 Regulation FD Disclosure.

On November 18, 2025, HCW Biologics Inc. (the “Company”) issued a press release announcing that the first patient was dosed in a Company-sponsored, multi-center Phase 1 clinical trial to evaluate the Company’s lead product candidate, HCW9302, in patients with an autoimmune disorder. 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 November 18, 2025.
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:	November 18, 2025	By:	/s/ Hing C. Wong
			Hing C. Wong, Founder and Chief Executive Officer

FAQ

What announcement did HCW Biologics (HCWB) make in this 8-K filing?

HCW Biologics announced that the first patient was dosed in a company-sponsored, multi-center Phase 1 clinical trial evaluating its lead product candidate, HCW9302, in patients with an autoimmune disorder.

What is HCW9302 according to HCW Biologics (HCWB)?

HCW9302 is described as HCW Biologics’ lead product candidate, which is being evaluated in a company-sponsored, multi-center Phase 1 clinical trial in patients with an autoimmune disorder.

What stage of development is HCW9302 in for HCW Biologics (HCWB)?

HCW9302 is being studied in a Phase 1 clinical trial, and the company reports that the first patient has been dosed in this trial.

How did HCW Biologics (HCWB) communicate the Phase 1 trial progress?

The company issued a press release dated November 18, 2025, announcing that the first patient was dosed in the Phase 1 trial of HCW9302 in an autoimmune disorder.

Is the HCW Biologics (HCWB) press release considered filed for liability purposes?

No. The company states that the information provided, including the press release, is furnished and not deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or incorporated by reference into other securities filings, except where specifically referenced.

What exhibit did HCW Biologics (HCWB) include with this 8-K?

HCW Biologics included Exhibit 99.1, identified as a press release dated November 18, 2025, along with Exhibit 104 for the cover page interactive data file.