Form 8-K

8-K — HCW Biologics Inc.

Accession: 0001493152-26-023122

Filed: 2026-05-14

Period: 2026-05-14

CIK: 0001828673

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

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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 14, 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 ☒

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

2.02 Results of Operations and Financial Condition.

May 14, 2026, HCW Biologics Inc. issued a press release announcing its financial results for the quarter ended March 31, 2026.

The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on

Form 8-K.

The

information set forth in this Item 2.02 (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for purposes

of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities

of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the

Exchange Act, regardless of any general incorporation language in such filing, except as 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 14, 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 14, 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 Reports First Quarter 2026

Business

Highlights and Financial Results

Miramar,

FL – May 14, 2026 – HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB),

a clinical-stage biopharmaceutical company focused on developing transformative fusion immunotherapeutics to treat autoimmune

disease, cancer and senescence-associated dysplasia, today reported financial results and recent business highlights for the

three months ended March 31, 2026.

The

Company remains on track to provide preliminary clinical data readout from the first two dose levels of the Phase 1 clinical study

evaluating HCW9302 in alopecia areata in the first half of 2026. There are two clinical sites actively enrolling patients,

and enrollment has been on schedule. HCW9302 is an injectable, first-in-kind interleukin 2 (“IL-2”) fusion protein

complex designed to suppress the hair-follicle killing activities of the auto-reactive immune cells typically found in patients

suffering with alopecia areata by activating and expanding regulatory T (“Treg”) cells. The Company has not reported

any dose limiting toxicities in the patients treated to date. With continued patient enrollment, the full Phase 1 human data readout

is expected in the fourth quarter of 2026.

Dr.

Hing C. Wong, the Company’s Founder and Chief Executive Officer, stated, “HCW9302 was selected as the lead product candidate

for the Company’s autoimmune program because it has demonstrated relatively high IL-2Rα affinity and sustains serum exposure,

which implies it has a strong profile for the treatment of autoimmune disorders. The Company’s preclinical studies in nonhuman

primates show that HCW9302 achieves significantly longer serum half-life and exhibits strong biological activity in relatively

low doses, which could appear in the human data readout as support for enhanced receptor selectivity, better tolerability

and reduced off-target effects.”

Business

Highlights

Transaction

Closed for Exclusive Worldwide License for HCW11-006

March 16, 2026, the closing for the licensing arrangement with Beijing Trimmune Biotech Co., Ltd

(“Trimmune”) occurred upon receipt of the full nonrefundable upfront license fee. The Trimmune upfront license fee

consisted of $3.5 million in gross cash proceeds, or $2.9 million net of taxes, and an in-kind payment of a transferable minority

equity interest in Trimmune with a fair value of $3.5 million. For the three months ended March 31, 2026, the Company recognized

$6.5 million in revenue and $470,000 in deferred revenue.

Commercial-Ready

Molecules Used as Reagents

March 13, 2026, Science Advances, a peer-reviewed, high-impact journal, released a publication with the Company’s data that showed

the Company’s proprietary, commercial-ready compound, HCW9206, could fundamentally change how CAR-T cell therapies are manufactured

and potential improve their clinical efficacy against diseases such as cancer and HIV. These findings support the Company’s belief

that HCW9206 is a leap forward in both clinical potential and manufacturing efficiency. The Company is actively seeking a corporate partner

to commercialize the reagent program.

February

2026 Equity Offering

February 19, 2026, the Company completed a $1.5 million equity financing with an existing investor in which it issued Pre-Funded Warrants

to purchase 2,477,292 shares of Common Stock for $0.0001 per share and Common Stock Warrants to purchase up to 2,477,292 shares of Common

Stock for $0.6055 per share. Contemporaneously with this transaction, the Company agreed to amend previously issued Common Stock Warrants

to purchase up to 3,020,410 shares of Common Stock to lower the exercise price from $2.41 per share to $0.6055 per share. The Warrants

are subject to stockholder approval.

First

Quarter 2026 Financial Results

Revenues:

Revenues for the three months ended March 31, 2025 and 2026 were $5,065 and $6.5 million, respectively. Since inception, the Company’s

revenues have been derived exclusively from its licenses. Under the Wugen License and supply agreements, the Company has recognized over

$16.0 million of aggregate revenues since the inception of the license in 2020. In the three months ended March 31, 2025, Wugen was winding

down its clinical programs in NK-Cell therapies to focus exclusively on its breakthrough CAR-T program that is in its pivotal clinical

trial. In the three months ended March 31, 2026, the Company completed the closing of the exclusive, worldwide licensing agreement

with Trimmune for the in vivo rights for HCW11-006. The nonrefundable upfront license fee consisted of $3.5 million in gross cash

proceeds and $3.5 million in-kind in the form of a transferable minority equity interest in Trimmune.

Research

and development (R&D) expenses: R&D expenses for the three months ended March 31, 2025 and 2026 were $1.5 million and $1.3

million, respectively, a decrease of $220,763, or 15%. The change was primarily attributable to decreases of $272,757 in manufacturing

and materials costs and $60,287 in clinical expenses, partially offset by increases of $77,279 in salaries and benefits and $40,455 in

preclinical expenses.

General

and administrative (G&A) expenses: G&A expenses for the three months ended March 31, 2025 and 2026 were $2.2 million and

$1.8 million, respectively, a decrease of $394,320, or 18%. The change was primarily attributable to decreases of $265,137 in salaries

and benefits due to a decrease in stock-based compensation and $258,646 in accretion of a fixed bonus payable upon the maturity date

of Secured Notes due to restructuring of the Secured Notes in May 2025, partially offset by increases in taxes and expenses related to

financings.

Legal

expenses (recoveries), net: Legal expenses and recoveries, net represent the legal fees that the Company incurred for an Arbitration,

net of insurance recoveries. In the three months ended March 31, 2025, the Company received a $2.0 million insurance recovery, partially

offset by $260,507 of legal expenses. The Company anticipates it will continue to incur expenses for the costs of remaining in compliance

with the terms of the Settlement and Release Agreement, primarily due to requirements for patents which are necessary to protect the

Company’s intellectual property rights.

Net

income (loss): Net income (loss) for the three months ended March 31, 2025 and 2026 were a loss of $2.2 million and income of $3.5

million, respectively.

Financial

Guidance

of March 31, 2026, the Company believes that substantial doubt exists regarding its ability to continue as a going concern for at least

12 months from the issuance date of the audited financial statements, without additional funding or financial support. We considered

future elements of our financing plan, especially business development programs. We have had early success in completing key elements

of our multi-step financing plan; however, we cannot be assured that we will continue to have success with remaining elements of our

plan.

May 5, 2026, the Company was granted a Hearing to appeal a determination by the Nasdaq Listing Qualifications Staff (the “Staff”)

to delist the Company’s securities from The Nasdaq Capital Market (“Nasdaq”) due to the Company’s non-compliance

with the $1.00 minimum bid price requirement. The Staff will require a brief period of deliberations before notification

of whether the Company’s plan was accepted.

About

HCW Biologics

HCW

Biologics Inc. (the “Company”) (NASDAQ: HCWB) is a clinical-stage biopharmaceutical company developing transformative fusion

immunotherapeutics to support or 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. 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. 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, including timing and efficacy in human clinical

trial data for HCW9302, correlation of primate studies to potential data from the clinical trial, and the ability of HCW9206 to increase

efficacy in CAR-T programs. 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 Form 10-Q filed with the SEC on May 14, 2026, and in other

filings filed from time to time with the SEC. Forward-looking statements contained in this press release are made as of this date, and

the Company undertakes no duty to update such information except as required under applicable law.

Company

Contact:

Rebecca

Byam

CFO

HCW

Biologics Inc.

rebeccabyam@hcwbiologics.com

HCW

Biologics Inc.

Condensed

Statements of Operations

(Unaudited)

Three Months Ended

March 31,

2025

2026

Revenues:

Revenues

$ 5,065

$ 6,543,001

Cost of revenues

(4,052 )

(11,071 )

Net revenues

1,013

6,531,930

Operating expenses:

Research and development

1,478,711

1,257,948

General and administrative

2,227,597

1,833,277

Legal expenses, net

(1,739,493 )

6,850

Indirect tax expense

—

198,146

Total operating expenses

1,966,815

3,296,221

Operating income (loss)

(1,965,802 )

3,235,709

Interest expense

(255,822 )

(109,274 )

Change in fair value of warrant liability

—

667,343

Other income, net

24,749

8,888

Net income (loss) before income taxes

$ (2,196,875 )

$ 3,802,666

Income tax expense

—

(330,186 )

Net income (loss)

$ (2,196,875 )

$ 3,472,480

Equity dividend to investor

—

(1,488,472 )

Net income (loss) attributable to Common Stockholders

$ (2,196,875 )

$ 1,984,008

Net income (loss) per share, basic and diluted

$ (1.97 )

$ 0.37

Weighted average shares outstanding, basic and diluted

1,116,891

5,425,871

HCW

Biologics Inc.

Condensed

Balance Sheets

December 31,

March 31,

2025

2026

Unaudited

ASSETS

Current assets:

Cash and cash equivalents

$ 1,952,464

$ 1,228,879

Accounts receivable, net

32,175

74,844

Prepaid expenses

222,156

297,760

Other current assets

77,564

119,843

Total current assets

2,284,359

1,721,326

Investments

1,326,329

4,826,329

Property, plant and equipment, net

20,880,849

20,766,082

Other assets

28,476

Total assets

$ 24,520,013

$ 27,342,213

LIABILITIES AND STOCKHOLDERS’ EQUITY

Liabilities

Current liabilities:

Accounts payable

$ 13,143,394

$ 11,785,980

Accrued liabilities and other current liabilities

1,110,104

1,125,639

Short-term debt, net

6,809,215

6,577,194

Deferred Revenue

—

470,000

Total current liabilities

21,062,713

19,958,813

Warrant liability

928,435

Contingent liability

692,531

Total liabilities

21,755,244

21,579,779

Stockholders’ equity:

Common stock:

Common, $0.0001 par value; 250,000,000 shares authorized and 3,279,812 shares issued at December 31, 2025; 250,000,000 shares authorized and 6,734,104 shares issued at March 31, 2026

328

673

Additional paid-in capital

111,280,287

110,805,127

Accumulated deficit

(108,515,846 )

(105,043,366 )

Total stockholders’ equity

2,764,769

5,762,434

Total liabilities and stockholders’ equity

$ 24,520,013

$ 27,342,213

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