HCW Biologics (HCWB) posts higher 2026 revenue but flags going-concern risk
Rhea-AI Filing Summary
HCW Biologics Inc. reported second-quarter and first-half 2026 results alongside business and clinical updates. Preliminary human data from a Phase 1 alopecia areata study of lead autoimmune candidate HCW9302 showed early signs of efficacy with ≥25% SALT score reductions in all three patients in the second dose cohort, without dose-limiting toxicities or key IL‑2–related side effects.
The company re-acquired ex vivo rights to two commercial-ready molecules from AlloTera Therapeutics and is seeking a partner to commercialize HCW9206 and related molecules as reagents for CAR‑T manufacturing. It is advancing tetravalent T‑cell engager HCW11-018b, having requested a Type B pre‑IND meeting with the FDA, targeting a first clinical trial in the first half of 2027, subject to authorization.
HCW completed $5.6 million of equity financings in May and July 2026 involving common stock, pre-funded warrants and common warrants. Revenue rose to $135,568 for the quarter and $6.7 million for the first half of 2026, driven by a licensing agreement with Trimmune. Net loss was $5.2 million for the quarter and $1.7 million for the first half, with a fair value loss on warrant liabilities partly offset by a gain on extinguishment of a liability. As of June 30, 2026, the company reported substantial doubt about its ability to continue as a going concern without additional funding. Cash and cash equivalents were $741,324, and a one-for-six reverse stock split was effected on June 30, 2026. HCW regained compliance with Nasdaq bid price and equity listing rules, with a potential one-year discretionary panel monitor if conditions are maintained through September 22, 2026.
Positive
- Revenue surged to $135,568 for Q2 2026 and $6.7 million for the first half of 2026, primarily from the Trimmune licensing agreement and related services.
- $5.6 million in equity financings in May and July 2026 strengthened capital resources, with meaningful participation from officers, directors, and significant stockholders.
- Preliminary Phase 1 data for HCW9302 in alopecia areata showed ≥25% SALT score improvement in all three patients in the second cohort with no dose-limiting toxicities.
- HCW re-acquired ex vivo rights to two commercial-ready molecules, including HCW9206, creating a potential revenue stream as reagents for CAR‑T manufacturing.
- The company is advancing HCW11-018b, a tetravalent T‑cell engager, toward a first clinical trial targeted for the first half of 2027, subject to FDA authorization.
- HCW regained compliance with Nasdaq Equity Rule 5550(b)(1) and Bid Price Rule 5550(a)(2), reducing near-term delisting risk.
Negative
- Management disclosed substantial doubt about the company’s ability to continue as a going concern for at least 12 months from June 30, 2026 without additional funding.
- Q2 2026 net loss widened to $5.2 million, driven partly by a $2.4 million loss from changes in fair value of warrant liabilities.
- Cash and cash equivalents declined to $741,324 at June 30, 2026, versus current liabilities of $18.6 million, indicating tight liquidity.
- Net loss attributable to common stockholders was $15.4 million for Q2 2026 and $13.4 million for the first half, including large equity dividends to an investor.
- Total operating expenses for the first half of 2026 were $6.4 million, exceeding net revenues and contributing to ongoing losses.
Filing Explained
The completed July financing added common shares and created securities tied to up to 618,682 more, while resale registration remains pending.
HCW Biologics completed the July private placement, issuing
The common-stock issuance added shares to the issued share count, while the warrant instruments represent additional potential shares only if exercised. A private placement is a sale to selected investors outside a public offering; the filing's registration obligation concerns resale of the securities, not a new issuance stated here.
As of
8-K Event Classification
Key Figures
Key Terms
SALT scores medical
pre-funded warrants financial
tetravalent T-cell engager medical
going concern financial
reverse stock split financial
cGMP material technical
Earnings Snapshot
The company indicated substantial doubt about its ability to continue as a going concern for at least 12 months from June 30, 2026 without additional funding or financial support.
FAQ
How did HCW Biologics (HCWB) perform financially in Q2 2026?
What going-concern risks did HCW Biologics (HCWB) disclose?
What were HCW Biologics’ (HCWB) cash and debt positions at June 30, 2026?
What clinical progress did HCW Biologics (HCWB) report for HCW9302?
What are the key financing activities for HCW Biologics (HCWB) in 2026?
How did the Trimmune licensing agreement impact HCW Biologics’ (HCWB) 2026 results?
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AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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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
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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.
On August 14, 2026, HCW Biologics Inc. issued a press release announcing its financial results for the quarter ended June 30, 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 August 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: August 14, 2026 | By: | /s/ Hing C. Wong |
| Hing C. Wong | ||
| Founder and Chief Executive Officer | ||
EXHIBIT 99.1
HCW Biologics Reports Second Quarter 2026
Business
Miramar,
FL – August 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
On June 16, 2026, the Company announced its preliminary human data readout for the first two cohorts in a dose-escalating Phase 1 clinical study to evaluate HCW9302 as a monotherapy in patients with alopecia areata. HCW9302 is a fusion immunotherapeutic which is potentially a best-in-class IL-2-based treatment for autoimmune diseases. These preliminary findings support the Company’s belief that HCW9302 has the potential to activate and expand regulatory T (Treg) cells in patients, reducing inflammation, while minimizing the risk of broad immunosuppression or unwanted side effects caused by the activation of immune effector cells.
The Company remains on track for a full Phase 1 clinical data readout in the fourth quarter of 2026. Treatment of patients in the third dose cohort (i.e., eight (8) micrograms/kg body weight) is underway and evaluation of correlative study endpoints is ongoing. The Company has not reported any dose-limiting toxicities.
In the second dose cohort, comprised of patients who received a single subcutaneous dose of HCW9302 monotherapy of three (3) micrograms/kg body weight, all three participants showed preliminary indications of improvement in Severity of Alopecia Tool (“SALT”) scores. These three participants, all with mild alopecia, showed a ≥25% reduction in SALT scores compared to baseline at four and/or nine weeks after dosing. In addition, there were no reported incidences of capillary leak or cytokine release syndromes associated with high dose intravenous IL-2 therapy. HCW9302 treatment did not increase blood eosinophil count, another serious side effect commonly associated with IL-2 therapy.
Dr.
Hing C. Wong, the Company’s Founder and Chief Executive Officer, stated, “HCW9302 was selected as our lead product candidate
for our autoimmune program because it has several unique features that differentiate it from other immunotherapeutic treatments for autoimmune
disorders. Because our clinical study was designed to administer HCW9302 as a monotherapy, we feel confident of our findings and clear
signals that indicate this drug has great potential.
Dr. Wong continued, “HCW9302 targets CD25 directly, which we believe demonstrates activation and expansion of regulatory T cells. It has preliminarily demonstrated it has an effect on alopecia areata, even when administered as monotherapy at a low dose. Our design does not use pegylation, so we avoid anti-PEG immune responses, which account for efficacy loss and can possibly cause severe allergic symptoms. With an eye toward the future commercialization of HCW9302 for the treatment of alopecia areata and other autoimmune disorders, we developed a manufacturing process for this drug that is a simple process capable of producing large quantities with consistent quality at a relatively low cost.”
Business
Commercial-Ready Molecules Used as Reagents
Since the second quarter of 2025, the AlloTera Therapeutics License (formerly the Wugen License) was in a one-year suspension period, which the Company agreed to at the request of AlloTera Therapeutics, Inc. (“AlloTera Therapeutics”). On May 21, 2026, the Company re-acquired the ex vivo rights to two commercial-ready molecules that had previously been licensed to AlloTera Therapeutics by exercising its right to terminate the AlloTera Therapeutics License Agreement according to the terms of the suspension letter agreement.
The
Company is actively pursuing a corporate partner to commercialize
The market for reagents used in CAR-T therapy production is experiencing rapid expansion, driven by a projected increase in the global CAR-T cell therapy market, which is expected to grow from $4.0 billion in 2025 to over $15.0 billion by 2032. One of the impediments to growth is the manufacturing process, which is subject to delays and has difficult meeting target doses for commercial production.
Pursuant to a May 2026 securities purchase agreement, in a private placement, the Company issued and sold an aggregate of 71,174 shares of Common Stock, 403,322 Pre-Funded Warrants, and Common Warrants to purchase an aggregate of up to 474,496 shares of Common Stock for aggregate gross proceeds of approximately $4.0 million at the closing, before deducting fees payable to the placement agent and other offering expenses payable by the Company. The Investors included officers, directors and significant stockholders. Scott Garrett, Chairman of the Company’s Board of Directors, purchased $250,000 of securities, Hing C. Wong, the Company’s Founder and Chief Executive Officer, purchased $160,000 of securities, and Rebecca Byam, the Company’s Chief Financial Officer, purchased $20,000 of securities. Such purchases were made on the same terms and conditions as those offered to other investors. On June 18, 2026, the SEC declared effective a resale registration statement on Form S-1 (File No. 333-296577) covering the resale of shares of Common Stock and warrants issued in this private placement.
Pursuant to a July 2026 securities purchase agreement, in a private placement, the Company issued and sold an aggregate of 218,862 shares of Common Stock, 400,000 Pre-Funded Warrants and Common Warrants to purchase an aggregate of 618,682 shares of Common Stock for aggregate proceeds of approximately $1.6 million at closing, before deducting offering fees. The Investors included officers and directors. Scott Garrett purchased $20,000 of securities, Hing C. Wong purchased $60,000 of securities, and Lee Flowers, the Company’s SVP Business Development, purchased $20,000 of securities. Under a Registration Rights Agreement, the Company is obligated to file a registration statement to register the securities sold in this offering within 15 business days from closing.
Second Quarter 2026 Financial Results
Revenues: Revenues for the three months ended June 30, 2025 and 2026 were $6,550 and $135,568, respectively. Revenues in the six months ended June 30, 2025 and 2026 were $11,615 and $6.7 million, respectively. In the three and six months ended June 30, 2026, the Company completed the closing of the exclusive, worldwide licensing agreement with Beijing Trimmune Biotech Co., Ltd. (“Trimmune”) for the in vivo rights for HCW11-006 (“Trimmune License”) and performed additional post-transfer services under the agreement.
Research and development (R&D) expenses: R&D expenses for the three months ended June 30, 2025 and 2026 were $1.2 million and $1.2 million, respectively, a decrease of $23,472, or 2%. The decrease was primarily due to decreases in salaries, benefits and related taxes and clinical trial expenses, partially offset by an increase in preclinical expenses with a focus on IND-enabling activities for the Company’s lead product T-Cell Engager candidate, HCW11-018b. R&D expenses for the six months ended June 30, 2025 and 2026 were $2.7 million and $2.5 million, respectively, a decrease of $244,236, or 9%. The decrease was primarily due to a decline in manufacturing and materials expenses, partially offset by increases in taxes and salaries, benefits and related expenses.
General and administrative (G&A) expenses: G&A expenses for the three months ended June 30, 2025 and 2026 were $2.1 million and $1.9 million, respectively, a decrease of $225,646, or 11%. The decrease was primarily attributable to decreases of $242,073 in salaries and benefits related to a decline in stock-based compensation expense, $87,835 in accretion expense for the fixed bonus payable upon the maturity date of outstanding Secured Notes and a $79,518 decrease in insurance premiums, partially offset by increases in taxes and expenses related to financing activities. In May 2025, the Company restructured $7.4 million of debt related to the Secured Notes, and these Noteholders converted to equity. G&A expenses for the six months ended June 30, 2025 and 2026 were $4.3 million and $3.7 million, respectively, a decrease of $598,649, or 14%. The decrease was primarily attributable to decreases of $507,206 in salaries and benefits related to a decline in stock-based compensation expense and $346,482 in accretion expense for the fixed bonus payable upon maturity date of outstanding Secured Notes and a decrease of $175,343 in insurance premiums, partially offset by an increase in taxes and expenses related to financing activities.
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 six months ended June 30, 2025, the Company received a $2.0 million insurance recovery, partially offset by $403,049 of legal expenses. The Company anticipates it will continue to incur some expenses for the costs of remaining in compliance with the terms of the Settlement and Release Agreement from the Arbitration, primarily due to requirements for patents which are necessary to protect the Company’s exclusive, worldwide intellectual property rights held in perpetuity.
Nonoperating
changes impacting net income (loss): The Company adopted the fair value method of accounting for its shares in AlloTera Therapeutics
in the second quarter of 2025. As a result, in the three and six months ended June 30, 2025, the Company recognized a $1.7 million gain
in both periods related to a change in the fair value for this investment. The Company recognized a warrant liability in connection with
warrants with a contingent settlement provision which was resolved on June 15, 2026. As a
Net loss: Net loss for the three months ended June 30,2025 and 2026 was $1.9 million and $5.2 million, respectively. Net loss for the six months ended June 30, 2025 and 2026, was $4.1 million and $1.7 million, respectively.
Financial Guidance
As of June 30, 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.
On
June 26, 2025, the Company announced that it received formal notice from The Nasdaq Stock Market LLC (“Nasdaq”) that the
Company is in compliance with Listing Rule 5550(b)(1) (the “Equity Rule”). On June 29, 2026, HCW Biologics Inc. (the “Company”)
received written notice form the Listing Qualifications Staff (the “Staff”) of the Nasdaq Capital Market Nasdaq Stock Market
LLC (“Nasdaq”) that the Nasdaq Hearings Panel (the “Panel”) found that the Company regained compliance with Listing
Rule 5550(a)(2), the “Bid Price Rule,” per the terms set forth in the Panel’s decision letter dated May 29, 2026, as
amended. As indicated in the Panel’s decision letter, as amended, if the Company satisfies the remaining terms of the decision
through September 22, 2026, the Panel also intends to impose a Discretionary Panel Monitor on the Company pursuant to Listing Rule 5815(d)(4)(A)
for a one-year period from that date.
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. 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. 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, ability of HCW11-018b to treat solid tumors, ability to obtain U.S. Food and Drug Administration clearance to advance Phase 2 clinical trials for HCW9302, success in obtaining FDA clearance to initiate clinical trials for HCW11-018b, and effectiveness of commercial-ready reagents for production of immunotherapeutics; and the Company’s ability to license or sell reagents. 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 June 30, 2026, the Form 10-Q filed with the SEC on August 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 June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2026 | 2025 | 2026 | |||||||||||||
| Revenues: | ||||||||||||||||
| Revenues | $ | 6,550 | $ | 135,568 | $ | 11,615 | $ | 6,678,569 | ||||||||
| Cost of revenues | (5,240 | ) | (229,455 | ) | (9,292 | ) | (240,526 | ) | ||||||||
| Net revenues | 1,310 | (93,887 | ) | 2,323 | 6,438,043 | |||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 1,226,824 | 1,203,352 | 2,705,536 | 2,461,300 | ||||||||||||
| General and administrative | 2,096,021 | 1,870,375 | 4,302,301 | 3,703,652 | ||||||||||||
| Legal expenses (recoveries), net | 142,542 | (1,325 | ) | (1,596,951 | ) | 5,525 | ||||||||||
| Indirect tax expense | - | - | - | 198,146 | ||||||||||||
| Total operating expenses | 3,465,387 | 3,072,402 | 5,410,886 | 6,368,623 | ||||||||||||
| Operating income (loss) | (3,464,077 | ) | (3,166,289 | ) | (5,408,563 | ) | 69,420 | |||||||||
| Interest expense | (228,714 | ) | (100,541 | ) | (505,853 | ) | (209,815 | ) | ||||||||
| Change in fair value of warrant liability | - | (2,443,335 | ) | - | (1,775,992 | ) | ||||||||||
| Change in fair value of investment, net | 1,748,688 | - | 1,748,688 | - | ||||||||||||
| Gain on extinguishment of liability | - | 483,383 | - | 483,383 | ||||||||||||
| Other income, net | 16,373 | 7,551 | 41,122 | 16,439 | ||||||||||||
| Net loss before income taxes | $ | (1,927,730 | ) | $ | (5,219,231 | ) | $ | (4,124,606 | ) | $ | (1,416,565 | ) | ||||
| Income tax expense | - | - | - | (330,186 | ) | |||||||||||
| Net loss | $ | (1,927,730 | ) | $ | (5,219,231 | ) | $ | (4,124,606 | ) | $ | (1,746,751 | ) | ||||
| Equity dividend to investor | (10,153,799 | ) | (10,154,642 | ) | (10,153,799 | ) | (11,643,114 | ) | ||||||||
| Net loss attributable to Common Stockholders | $ | (12,081,529 | ) | $ | (15,373,873 | ) | $ | (14,278,405 | ) | $ | (13,389,865 | ) | ||||
| Net loss per share, basic and diluted | $ | (40.72 | ) | $ | (11.58 | ) | $ | (59.14 | ) | $ | (11.98 | ) | ||||
| Weighted average shares outstanding, basic and diluted | 296,686 | 1,327,966 | 241,417 | 1,117,350 | ||||||||||||
HCW Biologics Inc.
Condensed Balance Sheets
| December 31, | June 30, | |||||||
| 2025 | 2026 | |||||||
| Unaudited | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 1,952,464 | $ | 741,324 | ||||
| Accounts receivable, net | 32,175 | 18,451 | ||||||
| Prepaid expenses | 222,156 | 282,533 | ||||||
| Other current assets | 77,564 | 97,702 | ||||||
| Total current assets | 2,284,359 | 1,140,010 | ||||||
| Investments | 1,326,329 | 4,854,028 | ||||||
| Property, plant and equipment, net | 20,880,849 | 20,745,804 | ||||||
| Other assets | 28,476 | 28,476 | ||||||
| Total assets | $ | 24,520,013 | $ | 26,768,318 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Liabilities | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 13,143,394 | $ | 10,609,950 | ||||
| Accrued liabilities and other current liabilities | 1,110,104 | 1,128,592 | ||||||
| Short-term debt, net | 6,809,215 | 6,561,361 | ||||||
| Deferred revenue | — | 348,270 | ||||||
| Total current liabilities | 21,062,713 | 18,648,173 | ||||||
| Contingent liability - related party | 692,531 | 692,531 | ||||||
| Total liabilities | 21,755,244 | 19,340,704 | ||||||
| Commitments and contingencies (Note 12) | ||||||||
| Stockholders’ equity: | ||||||||
| Common stock: | ||||||||
| Common, $0.0001 par value; 250,000,000 shares authorized and 546,635 shares issued at December 31, 2025; 250,000,000 shares authorized and 1,617,642 shares issued at June 30, 2026 | 55 | 161 | ||||||
| Additional paid-in capital | 111,280,560 | 117,690,050 | ||||||
| Accumulated deficit | (108,515,846 | ) | (110,262,597 | ) | ||||
| Total stockholders’ equity | 2,764,769 | 7,427,614 | ||||||
| Total liabilities and stockholders’ equity | $ | 24,520,013 | $ | 26,768,318 | ||||