HCW Biologics (NASDAQ: HCWB) turns Q1 profit but flags going concern risk
Rhea-AI Filing Summary
HCW Biologics reported first quarter 2026 results showing a sharp swing to profitability driven by a new licensing deal. Revenue for the three months ended March 31, 2026 rose to $6.54 million from $5,065 a year earlier, largely from an exclusive worldwide license for HCW11-006 with Trimmune that generated a $3.5 million cash fee and a $3.5 million equity interest. Net income for the quarter improved to $3.47 million from a loss of $2.20 million, while net income attributable to common stockholders was $1.98 million, or $0.37 per share. Despite the stronger quarter, the company states there is “substantial doubt” about its ability to continue as a going concern over the next 12 months without additional funding, and it is appealing a Nasdaq decision to delist its shares for failing to meet the $1.00 minimum bid price requirement.
Positive
- None.
Negative
- Going concern uncertainty: As of March 31, 2026, the company states that substantial doubt exists about its ability to continue as a going concern for at least 12 months without additional funding or financial support.
- Nasdaq delisting risk: The company has been called to a Nasdaq hearing after staff determined it was non-compliant with the $1.00 minimum bid price requirement, creating a risk its shares could be delisted.
Insights
Quarter driven by licensing win, but going concern and listing risk dominate.
HCW Biologics posted Q1 2026 revenue of $6.54M, up from $5,065, and net income of $3.47M versus a prior loss. The step-change stems mainly from the HCW11-006 license to Trimmune, including cash and an equity stake.
Core R&D and G&A costs declined (15% and 18%, respectively), but cash and cash equivalents were only $1.23M as of March 31, 2026. Total liabilities of $21.58M far exceed cash, even with higher total assets from the Trimmune investment.
The company explicitly notes substantial doubt about its ability to continue as a going concern for at least 12 months without new funding, and it faces a Nasdaq hearing over non-compliance with the $1.00 minimum bid price. Subsequent filings may clarify whether the financing plan and listing appeal progress favorably.
8-K Event Classification
Key Figures
Key Terms
Phase 1 clinical study medical
CAR-T cell therapies medical
going concern financial
warrant liability financial
Deferred Revenue financial
Nasdaq Capital Market regulatory
Earnings Snapshot
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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FORM
CURRENT REPORT
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Item 2.02 Results of Operations and Financial Condition.
On 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 | ||
EXHIBIT 99.1
HCW Biologics Reports First Quarter 2026
Business Highlights and Financial Results
Miramar,
FL – May
The
Company remains on track to provide preliminary clinical data readout from
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
Business Highlights
Transaction Closed for Exclusive Worldwide License for HCW11-006
On
March
Commercial-Ready Molecules Used as Reagents
On 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
On
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
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
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
Financial Guidance
As 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.
On
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
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
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 | ) | ||||
| — | 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 | — | ) | ||||||
| Net income (loss) attributable to Common Stockholders | $ | (2,196,875 | ) | $ | ||||
| Net income (loss) per share, basic and diluted | $ | (1.97 | ) | $ | ||||
| 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 | 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 | 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 | ||||