HCW Biologics Reports Second Quarter 2026 Business and Clinical Development Highlights and Financial Results
Rhea-AI Summary
HCW Biologics (NASDAQ: HCWB) reported second quarter 2026 results and business updates, combining clinical progress, partnering activity and financing steps. For Q2 2026, revenue rose to $135,568 from $6,550, while six‑month 2026 revenue increased to $6.7 million, largely from closing the Trimmune licensing agreement and related services. Q2 2026 net loss widened to $5.2 million versus $1.9 million a year earlier, but six‑month 2026 net loss narrowed to $1.7 million from $4.1 million.
HCW reported preliminary Phase 1 data for HCW9302 in alopecia areata, with all three patients in the second dose cohort showing ≥25% SALT score reductions and no dose‑limiting toxicities. The company also advanced its T‑cell engager HCW11‑018b toward a planned IND by requesting a Type B FDA meeting.
HCW re‑acquired ex vivo rights to two HCW9206‑related molecules and is seeking partners to commercialize them as CAR‑T manufacturing reagents. It raised roughly $5.6 million in two Q2/Q3 2026 private placements involving insiders, reclassified certain warrants to equity, and settled a $1.7 million liability for $1.2 million. Management nonetheless stated there is substantial doubt about the company’s ability to continue as a going concern without additional funding. HCW regained Nasdaq bid‑price compliance and executed a one‑for‑six reverse stock split on June 30, 2026.
Positive
- Six‑month 2026 revenue $6.7 million versus $11,615 in 2025, driven by Trimmune license
- Q2 2026 net loss $5.2 million, but six‑month 2026 net loss improved to $1.7 million from $4.1 million
- Preliminary HCW9302 Phase 1 data show ≥25% SALT score reduction in all three second‑cohort patients and no dose‑limiting toxicities
- HCW11‑018b T‑cell engager advanced via FDA pre‑IND Type B meeting request, with trial targeted to start in first half 2027 subject to authorization
- $5.6 million total gross proceeds from May and July 2026 private placements, with participation from officers and directors
- Nasdaq listing compliance regained with Bid Price Rule and Equity Rule; one‑for‑six reverse stock split completed June 30, 2026
Negative
- Substantial doubt about going concern status disclosed as of June 30, 2026 without additional funding or support
- Q2 2026 net loss widened to $5.2 million from $1.9 million, including a $2.4 million loss from warrant liability fair‑value changes
- Equity financings of $5.6 million involved issuance of 290,036 common shares and 803,322 pre‑funded warrants, increasing potential share count
- Revenue remains modest in Q2 2026 at $135,568, with six‑month results heavily reliant on one licensing transaction and related services
- Ongoing costs from Arbitration settlement expected as the company maintains patent compliance obligations tied to its IP rights
News Explained
Closed financings add cash, while potential warrant exercise could increase dilution amid stated funding pressure.
HCW Biologics completed its May and July private placements, issuing common stock and selling pre-funded and common warrants; the financings provide cash but create present and potential future share-count increases for existing holders.
In the May placement, the company issued
In July, it issued
Additional shares reduce an existing holder's percentage ownership, while pre-funded warrants convert to shares when exercised, so dilution is partly issued and partly conditional on warrant exercise.
At
The July financing's registration-rights agreement requires a resale registration statement within 15 business days of closing, and Nasdaq's remaining compliance terms run through
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jul 29 | Private placement | Negative | -0.2% | Company priced a $1.6 million private placement involving shares and warrants. |
| Jul 23 | T-cell engager update | Positive | -13.9% | Company reported pre-IND progress and a planned first-half 2027 clinical trial. |
| Jun 30 | Nasdaq compliance | Positive | -5.1% | Company regained compliance with Nasdaq's Bid Price Rule. |
| Jun 26 | Reverse stock split | Negative | -8.0% | Company announced a one-for-six reverse stock split effective June 30. |
| Jun 16 | Phase 1 clinical data | Positive | -6.6% | Three participants showed at least 25% reductions in SALT scores. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
HCWB historically declined after positive clinical, development, and Nasdaq-compliance announcements, while the recent private placement produced a smaller decline.
Key Terms
il-2 medical
pre-ind application regulatory
cgmp technical
pharmacokinetics medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
MIRAMAR, Fla., Aug. 14, 2026 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on developing transformative fusion immunotherapeutics to treat autoimmune diseases, cancer and senescence-associated dysplasia, today reported financial results and recent business highlights for the three and six months ended June 30, 2026.
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 ≥
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. So far, our in-human clinical experience with HCW9302 is consistent with our preclinical results showing HCW9302’s effectiveness in alopecia areata and atopic dermatitis in relevant animal models.”
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 and Clinical Development Highlights
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 HCW9206 and like molecules as reagents to support the production of cell-based immunotherapeutics, particularly CAR-T therapies. In collaboration with researchers at the Albert Einstein College of Medicine, the Company demonstrated and published in a scientific paper in Science Advances that replacing standard activation with HCW9206 during CAR-T cell manufacturing significantly increased the long-term persistence, functionality, and proportion of T memory stem cells in immunotherapies for cancer and HIV and potentially significantly lowers the production costs.
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
Milestone for Company’s T-Cell Engager Program
The Company requested a Type B (pre-IND application) meeting with the U.S. Food and Drug Administration (“FDA”) to discuss the development and regulatory strategy for its investigational lead product candidate, HCW11-018b, a tetravalent T-cell engager (“TCE”) constructed with the Company’s proprietary TRBC drug development platform. The Company would like to reach agreement with the FDA on requirements for a clinical study before we submit an IND application to evaluate HCW11-018b in cancer. This clinical trial is on track to initiate in the first half of 2027, provided we secured FDA authorization.
HCW11-018b is intended to treat solid tumors and is administered by subcutaneous injection. In preclinical studies, it has shown the ability to target tissue factor-expressing cancer cells and activate CD3-positive effector T cells, while simultaneously reducing immunosuppression in the tumor microenvironment. Immunosuppression in the tumor microenvironment can limit effector T-cell infiltration and antitumor activity in solid tumors, particularly in gynecologic and pancreatic cancers.
The Company believes that our robust, streamlined, and cost-efficient manufacturing process will produce high-quality cGMP material to support clinical development. Our manufacturing process for HCW11-018b is based on high-producing recombinant CHO cell lines and a proprietary monoclonal antibody needed for the affinity purification process. This monoclonal antibody will be manufactured under GMP standards using a top-tier CDMO.
TCEs have emerged as a potent therapeutic modality to treat cancer. First-generation TCEs represented a breakthrough in immunotherapy but they continue to face significant challenges, including limited antigen selection, poor efficacy in solid tumors, tolerability and safety concerns, and complex manufacturing processes. Extensive preclinical studies of HCW11-018b —including assessments of in vitro and in vivo potency, antigen specificity, pharmacokinetics, toxicity in nonhuman primates, and its therapeutic window — suggest that HCW11-018b may be able to overcome the limitations of earlier-generation TCEs.
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
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
Second Quarter 2026 Financial Results
Revenues: Revenues for the three months ended June 30, 2025 and 2026 were
Research and development (R&D) expenses: R&D expenses for the three months ended June 30, 2025 and 2026 were
General and administrative (G&A) expenses: G&A expenses for the three months ended June 30, 2025 and 2026 were
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
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
Net loss: Net loss for the three months ended June 30,2025 and 2026 was
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. On June 30, 2026, the Company effected a one-for-six reverse stock split.
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, 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 | ||||
