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Investor releaseQuarter not tagged2026-08-14HCW Biologics Reports Second Quarter 2026 Business and Clinical Development Highlights and Financial Results
GlobeNewswire
HCW Biologics Reports Second Quarter 2026 Business and Clinical Development Highlights and Financial Results
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 ≥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 H…Read full documentShow less
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 ≥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. 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 $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. 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. $5.6 Million in Equity Financings 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 result, these warrants were reclassified to permanent equity. In the three and six months ended June 30, 2026, the changes in the fair value of the warrant liability prior to reclassification were a loss of $2.4 million and $1.8 million, respectively. In addition, during the three and six months ended June 30, 2026, the Company settled a $1.7 million liability for $1.2 million, and as a result recognized a gain on extinguishment of a liability of $483,383 in both periods. 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. 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 ByamCFOHCW Biologics [email protected]
Investor releaseQuarter not tagged2026-06-16HCW Biologics Announces Positive Results for Preliminary Human Data Readout for Phase 1 Clinical Trial Evaluating IL-2 Based Fusion Immunotherapeutic, HCW9302 Monotherapy, in Alopecia Areata
GlobeNewswire
HCW Biologics Announces Positive Results for Preliminary Human Data Readout for Phase 1 Clinical Trial Evaluating IL-2 Based Fusion Immunotherapeutic, HCW9302 Monotherapy, in Alopecia Areata
Potentially best-in-class IL-2 based treatment for autoimmune diseases by expanding and activating regulatory T cells Readout for dose-escalating clinical study for first two dose cohorts All participants in second dose cohort at the dose level of 3 micrograms/kg body weight showed positive clinical response after single dose administration Well tolerated, with no dose-limiting toxicities or significant known IL-2-treatment-related adverse effects, including no reported incidence of capillary leak, cytokine release syndrome, or increase in blood eosinophil counts HCW Biologics projects to establish the Recommended Phase 2 Dose by year end 2026 MIRAMAR, Fla., June 16, 2026 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (“HCWB” or the “Company”) (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company developing transformative fusion immunotherapeutics to support or treat diseases promoted by chronic inflammation, focusing on autoimmune disorders and other inflammatory diseases, cancer and senescence-associated dysplasia, today announced a positive preliminary human data readout for the first two dose cohorts from its dose-escalating Phase 1 clinical trial of HCW9302, an IL-2 based fusion immunotherapeutic, in patients with alopecia areata. 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. 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. All patients, including the first dose cohort at one (1) microgram/kg body weight and the second dose cohort at three (3) micrograms/kg body weight, received a single subcutaneous dose of HCW9302 monotherapy. There were no reported incidences of capillary leak or cytokine release syndromes associated with high dose intravenous IL-2 therapy. Additionally, HCW9302 treatment did not increase blood eosinophil counts, another serious side effect commonly associated with IL-2 therapy. All reported HCW9302 treatment emergent adverse events were mild in severi…Read full documentShow less
Potentially best-in-class IL-2 based treatment for autoimmune diseases by expanding and activating regulatory T cells Readout for dose-escalating clinical study for first two dose cohorts All participants in second dose cohort at the dose level of 3 micrograms/kg body weight showed positive clinical response after single dose administration Well tolerated, with no dose-limiting toxicities or significant known IL-2-treatment-related adverse effects, including no reported incidence of capillary leak, cytokine release syndrome, or increase in blood eosinophil counts HCW Biologics projects to establish the Recommended Phase 2 Dose by year end 2026 MIRAMAR, Fla., June 16, 2026 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (“HCWB” or the “Company”) (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company developing transformative fusion immunotherapeutics to support or treat diseases promoted by chronic inflammation, focusing on autoimmune disorders and other inflammatory diseases, cancer and senescence-associated dysplasia, today announced a positive preliminary human data readout for the first two dose cohorts from its dose-escalating Phase 1 clinical trial of HCW9302, an IL-2 based fusion immunotherapeutic, in patients with alopecia areata. 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. 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. All patients, including the first dose cohort at one (1) microgram/kg body weight and the second dose cohort at three (3) micrograms/kg body weight, received a single subcutaneous dose of HCW9302 monotherapy. There were no reported incidences of capillary leak or cytokine release syndromes associated with high dose intravenous IL-2 therapy. Additionally, HCW9302 treatment did not increase blood eosinophil counts, another serious side effect commonly associated with IL-2 therapy. All reported HCW9302 treatment emergent adverse events were mild in severity and self-limiting and resolved without medical intervention. The most common side effect was temporary injection-site reaction. 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. For alopecia areata, the Company believes that HCW9302 can suppress the hair-follicle killing activities of the auto-reactive immune cells by activating and expanding Treg cells. Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, commented, “The positive preliminary human data readout from the first two cohorts of the Phase 1 clinical study of HCW9302 monotherapy for alopecia areata is highly encouraging, showing potential benefit along with a well-tolerated safety profile even with a single, subcutaneous low-dose regimen. The results are consistent with our pre-clinical studies which demonstrated that HCW9302 exhibits a strong IL-2 receptor α bias, a unique and novel mechanism of action, while preferentially expanding and stimulating Treg cells to reduce pro-inflammatory and autoimmune responses in animal disease models, including alopecia and atherosclerosis. This strong IL-2Rα bias highly differentiates HCW9302 from native recombinant IL-2 and other IL-2-based muteins and PEG conjugates, which typically exhibit reduced binding activity to IL-2 receptor components. HCW9302 is comprised of all human-derived components and can be produced with a cost-effective, streamlined process similar to therapeutic monoclonal antibodies.” Dr. Wong continued, “We are progressing through dose escalation in this clinical study with the objective to establish the safe recommended Phase 2 dose by year-end. Patient enrollment remains on track, and we have initiated dosing patients in the third dose escalation cohort.” Dr. Wong added further thoughts about the indications that may be considered for Phase 2 clinical studies. He stated, “Once we achieve our objective to establish the recommended Phase 2 dose, we will consider expanding clinical studies to evaluate multi-dose HCW9302 monotherapy in Phase 2 studies in patients with alopecia areata, as well as other autoimmune diseases and inflammatory dermatological conditions, such as vitiligo and atopic dermatitis. We carefully monitor other potential indications with high unmet medical needs. We are very excited that recently published clinical evidence suggests that patients with Amyotrophic Lateral Sclerosis or ALS, an autoimmune neuroinflammatory disease, are expected to respond positively to combined Treg cell and IL-2 treatment. We believe HCW9302 could position the Company to explore the opportunity for treatment of patients afflicted with debilitating neurodegenerative diseases such as ALS.” About the HCW9302 Phase 1 Clinical Trial for Alopecia Areata: The Phase 1 multi-center dose-escalation study (Clinicaltrials.gov: NCT07049328) of HCW9302 monotherapy is designed to treat up to 30 patients with alopecia areata. The primary objectives of the study are to evaluate the safety of HCW9302, injected as a single dose under the skin (subcutaneously), and to determine the recommended dose level to advance to later phase clinical studies. Secondary objectives include assessment of disease responses and the effects of HCW9302 on proliferation and function of immune cells, particularly Treg cells. Depending on the results of this study, multi-dose studies of HCW9302 monotherapy in expanded cohorts of patients with alopecia areata and in patients with other inflammatory dermatological conditions are expected to be initiated. There are two active clinical sites enrolling patients, The Ohio State University Wexner Medical Center, Columbus, Ohio, and the James A. Haley Veterans’ Hospital, Tampa, Florida. About HCW9302: HCW9302 is the Company’s lead product candidate for its clinical program to develop treatments for autoimmune diseases and inflammatory conditions. HCW9302 is a subcutaneously injectable, first-in-kind IL-2 based fusion immunotherapeutic molecule constructed with a proprietary tissue factor scaffold. IL-2, the active component of HCW9302, is the cytokine in humans responsible for maintaining the proper numbers and functions of Treg cells in the body which control excessive inflammation caused by other immune cells, which is the etiology of autoimmune diseases. In pre-clinical studies, HCW9302 was found to bind with high affinity to the IL-2 receptor α chain (“IL-2Rα”) expressed on the surface of Treg cells, resulting in preferential stimulation of Treg proliferation and activation compared to CD4+ and CD8+ T cells and Natural Killer cells. This strong IL-2Rα bias highly differentiates HCW9302 from native recombinant IL-2 and other IL-2-based muteins and PEG conjugates, which typically exhibit reduced binding activity to IL-2 receptor components. As a result, HCW9302 treatment was found to induce Treg cell accumulation and activity and reduce pro-inflammatory and autoimmune responses in animal disease models, including alopecia and atherosclerosis. HCW9302 is comprised of all human-derived components and can be produced with a cost-effective streamline process similar to therapeutic monoclonal antibodies. About Alopecia Areata: Alopecia areata (“AA”) is one of the most prevalent autoimmune diseases in the world, affecting approximately 1 in 1,000 people, with a lifetime incidence of 2% worldwide, or 160 million people. According to the National Alopecia Areata Foundation, about 7 million people in the United States have alopecia areata. The condition primarily affects individuals under the age of 30, occurring at similar rates in both males and females. AA is characterized by hair loss in localized areas, the entire scalp, or, in some cases, the whole body. It occurs when the immune system mistakenly attacks hair follicles, leading to hair loss without causing permanent damage to the follicles. Patients often experience recurring episodes of hair loss throughout their lives. Existing treatments, such as corticosteroids, immunotherapy, Janus kinase inhibitors, and topical solutions, focus on managing the severity and duration of episodes of hair loss. However, these therapies primarily address symptoms rather than providing a cure or consistent, long-term hair regrowth. Currently, there is no cure for alopecia areata. 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. See the Company Pipeline at https://hcwbiologics.com/pipeline/ Forward Looking Statements: This press release contains “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 and include, the safety, ability and efficacy of HCW9302 to treat autoimmune diseases and other inflammatory diseases, including the efficacy of HCW9302 in the treatment of alopecia areata from preliminary clinical safety data; the ability of HCW9302 to advance to Phase 2 clinical trials; the ability of HCW9302 to treat other autoimmune or neurodegenerative conditions; and the selection of a safe recommended Phase 2 dose for HCW9302 by year end. 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. 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 quarterly report on Form 10-Q filed with the SEC on May 14, 2026, and in other filings filed from time to time with the SEC. Company Contact: Peter Rhode, PhD.Chief Scientific Officer and Vice President Clinical OperationsHCW Biologics [email protected]
Investor releaseQuarter not tagged2026-05-15HCW Biologics Reports First Quarter 2026 Business Highlights and Financial Results
GlobeNewswire
HCW Biologics Reports First Quarter 2026 Business Highlights and Financial Results
MIRAMAR, Fla., May 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 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 On 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, th…Read full documentShow less
MIRAMAR, Fla., May 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 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 On 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 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 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 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 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. [email protected]
Investor releaseQuarter not tagged2026-04-01HCW Biologics Reports Fourth Quarter 2025 and Fiscal Year 2025 Business Highlights and Financial Results
GlobeNewswire
HCW Biologics Reports Fourth Quarter 2025 and Fiscal Year 2025 Business Highlights and Financial Results
MIRAMAR, Fla., March 31, 2026 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company developing transformative fusion immunotherapeutics to support or treat diseases promoted by chronic inflammation, today reported financial results and recent business highlights for its three months ended December 31, 2025. On November 17, 2025, the Company initiated its first-in-human clinical trial to evaluate HCW9302, the lead product candidate for the Company’s program to develop treatments for autoimmune disorders and proinflammatory diseases, in patients with areata alopecia. HCW9302 is a subcutaneously injectable, first-in-kind interleukin-2 (“IL-2”) fusion immunotherapeutic. IL-2, the active component of HCW9302, is the cytokine in humans and other vertebrates responsible for maintaining the proper numbers and functions of Treg cells in the body. Treg cells control excessive inflammation caused by other immune cells, which is the etiology of autoimmune diseases. The Company believes that HCW9302 can suppress the hair-follicle killing activities of the auto-reactive immune cells by activating and expanding regulatory T cells (“Treg”) cells. There are no curative FDA approved treatments of this indication. Alopecia areata causes sudden hair loss and can have a significant negative impact on patients’ quality of life and psychological health. The National Alopecia Areata Foundation estimates approximately 160 million people worldwide and 7 million people in the United States have alopecia areata. The condition affects about 2% of the global population at some point in their lifetime. The Phase 1 multi-center dose-escalation study of HCW9302 is designed to treat up to 30 patients. The primary objectives of the study are to evaluate the safety of HCW9302, injected under the skin (subcutaneously), and to determine the recommended dose level to advance to later phase clinical studies. A preliminary human data read out is expected in the first half of 2026. Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer said, “We are excited to be the sponsor of this clinical study to evaluate this promising new treatment for alopecia areata. We will be conducting additional ancillary studies to provide further insights into disease responses and the effects of HCW9302 on proliferation and fun…Read full documentShow less
MIRAMAR, Fla., March 31, 2026 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company developing transformative fusion immunotherapeutics to support or treat diseases promoted by chronic inflammation, today reported financial results and recent business highlights for its three months ended December 31, 2025. On November 17, 2025, the Company initiated its first-in-human clinical trial to evaluate HCW9302, the lead product candidate for the Company’s program to develop treatments for autoimmune disorders and proinflammatory diseases, in patients with areata alopecia. HCW9302 is a subcutaneously injectable, first-in-kind interleukin-2 (“IL-2”) fusion immunotherapeutic. IL-2, the active component of HCW9302, is the cytokine in humans and other vertebrates responsible for maintaining the proper numbers and functions of Treg cells in the body. Treg cells control excessive inflammation caused by other immune cells, which is the etiology of autoimmune diseases. The Company believes that HCW9302 can suppress the hair-follicle killing activities of the auto-reactive immune cells by activating and expanding regulatory T cells (“Treg”) cells. There are no curative FDA approved treatments of this indication. Alopecia areata causes sudden hair loss and can have a significant negative impact on patients’ quality of life and psychological health. The National Alopecia Areata Foundation estimates approximately 160 million people worldwide and 7 million people in the United States have alopecia areata. The condition affects about 2% of the global population at some point in their lifetime. The Phase 1 multi-center dose-escalation study of HCW9302 is designed to treat up to 30 patients. The primary objectives of the study are to evaluate the safety of HCW9302, injected under the skin (subcutaneously), and to determine the recommended dose level to advance to later phase clinical studies. A preliminary human data read out is expected in the first half of 2026. Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer said, “We are excited to be the sponsor of this clinical study to evaluate this promising new treatment for alopecia areata. We will be conducting additional ancillary studies to provide further insights into disease responses and the effects of HCW9302 on proliferation and function of immune cells, particularly Treg cells.” Dr. Wong continued, “Based the results of our preclinical studies including non-human primates, we believe the human data read out will show that HCW9302 has superior IL-2Rα affinity and will sustain serum exposure, which could potentially make it favorable for the expansion and in increasing the functionality of Treg for autoimmune disease treatments. HCW9302 was well tolerated in non-human primate studies. If this remains the case in human studies, this would be a significant improvement over conventional IL-2 therapies that have low tolerability profiles. We believe the data will confirm that HCW9302 can achieve strong biological activity at lower therapeutic dose levels, and as a result, will have a favorable tolerability and at the same time can potentially enhance receptor selectivity and reduce off-target effects.” Business Highlights Upfront License Fee Received for Exclusive Worldwide License for HCW11-006 As of March 16, 2026, we received the full payment of the upfront licensing fee for the exclusive worldwide license for HCW11-006, a preclinical molecule licensed to Beijing Trimmune Biotech Co., Ltd. (“Trimmune”). The Company received $3.5 million in gross proceeds, and $2.9 million net after taxes. In addition to the cash portion of the upfront license fee, the Company received a transferable minority equity interest in Trimmune. HCW Biologics is eligible to receive additional payments under the license, including development milestone payments and double-digit royalties on future product sales, as well as a portion of the proceeds from certain future transaction(s) involving the licensed molecule, if and when such transaction(s) occur. Upon completion of Phase 1 by the licensee, the Company may exercise its Opt-In Rights to reclaim the rights to the Americas market. For an additional fee, Trimmune may exercise an option to license the China rights to HCW9302, the Company’s clinical-stage molecule, currently being evaluated in a Phase 1 trial in an autoimmune disorder. Commercial-Ready Molecules Used as Reagents During the year ended December 31, 2025, the Company launched two of its proprietary fusion protein molecules as commercial-ready molecules used as reagents to be used to support the production of cell-based immunotherapeutics to treat infectious diseases and cancer. While the Company’s focus remains on the development of fusion immunotherapeutics for the treatment of diseases promoted by chronic inflammation, the Company intends to market these reagents directly or through a corporate partnership to generate revenue which could offset development costs for its other immunotherapeutic treatments. 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. Fourth Quarter 2025 Financial Results Revenues: Revenues for the three months ended December 31, 2024 and 2025 were $394,804 and $27,010, respectively. Revenues for the years ended December 31, 2024 and 2025 were $2.6 million and $54,232, respectively. Historically, revenues have been derived exclusively from the sale of licensed molecules to the Company’s licensee, Wugen. In the year ended December 31, 2025, the Company agreed to a one-year suspension of the Wugen License Agreement in exchange for the exclusive right to market HCW9206 and HCW9201 as reagents and potentially identify a new corporate partner during this period. Research and development (R&D) expenses: R&D expenses for the three months ended December 31, 2024 and 2025 were $1.0 million and $1.3 million, respectively, an increase of $283,491, or 27%. R&D expenses for the years ended December 31, 2024 and 2025 were $6.4 million and $5.4 million, respectively, a decrease of $1.0 million, or 15%. R&D expenses in the year ended December 31, 2024 were higher than in the comparable period in 2025, due to higher expenses incurred for manufacturing and materials. General and administrative (G&A) expenses: G&A expenses for the three months ended December 31, 2024 and 2025 were $2.0 million and $1.5 million, respectively, a decrease of $526,175, or 26%. G&A expenses for the years ended December 31, 2024 and 2025 were $6.8 million and $7.7 million, respectively, an increase of $884,832 or 13%. The increase in G&A expenses in 2025 was primarily due to salaries and benefits and professional fees related to audit services, tax and other advisory services, as well as required activities to remain in compliance with SEC regulations and Nasdaq listing rules. Legal expenses (recoveries), net: Legal expenses and recoveries, net represent the legal fees that the Company incurred for an Arbitration which held its hearing in May 2024, was settled on July 13, 2024, and was dismissed on December 24, 2024. Legal expenses (recoveries), net for the three months ended December 31, 2024 and 2025 were $148,949 and $120,136, respectively. Legal expenses (recoveries), net for the years ended December 31, 2024 and 2025 were $15.9 million and a contra expense of ($1.5) million, respectively. In January 2025, the Company received a $2.0 million insurance reimbursement that was paid directly to the law firm involved in representing Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, in the Arbitration. The Company and Dr. Wong reached a settlement agreement in 2025 for the full balance of $7.5 million which was owed for legal fees incurred in connection with the defense for Dr. Wong, resulting in a gain of $5.5 million for the year ended December 31, 2025. Net (loss) gain: Net (loss) gain for the three months ended December 31, 2024 and 2025 was ($3.4) million and $2.2 million, respectively. Net loss for the years ended December 31, 2024 and 2025 was ($30.0) million and ($6.5) million, respectively. Financial Guidance As of December 31, 2025, 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, that were probable and likely to be implemented within the next year to determine if financing activities currently underway are sufficient to mitigate the substantial doubt in our going concern analysis. 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. An important part of the Company’s future financing plans is the ability to access the public markets for the sale of securities. On February 26, 2026, the Nasdaq Hearings Panel found that the Company regained compliance with all continued listing rules of The Nasdaq Capital Market. Pursuant to Listing Rule 5815(d)(4)(B), the Company will be subject to a Mandatory Panel Monitor. If, within that one-year monitoring period, the Staff again finds the Company to be out of compliance with the Equity Rule that was the subject of the exception, notwithstanding Rule 5810(c)(2), the Staff will issue a Delist Determination Letter and the Company will have an opportunity to request a new hearing with the initial Panel or a newly convened Hearings Panel if the initial Panel is unavailable. On March 26, 2026, the Company received a written notice from the Staff which notified the Company that, for the 30 consecutive business days, the Company’s security did not maintain a minimum bid price of $1 per share, in accordance with Nasdaq Listing Rule 5810(c)(3)(A) (“Bid Price Rule”). Due to the fact that the Company effected a 1-for-40 reverse stock split on April 11, 2025, the Company was not afforded a 180-calendar day period to demonstrate compliance. The Company plans to request an appeal of this determination in a timely manner. 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. Chronic inflammation is believed to be a significant contributing factor to the cause of conditions that diminish healthspan, including many types of cancer, autoimmune diseases and other proinflammatory diseases such as neurodegenerative diseases, as well as senescence-associated dysplasia, such as bronchopulmonary dysplasia, that impact quality-of-life but are not life-threatening. The Company has begun commercialization of certain commercial-ready proprietary compounds for use as reagents in the production of cell-based immunotherapeutics for the treatment of infectious diseases and cancer. HCW9206 is a reagent that supports a new method of generating highly functional human CAR-T cells for treating infectious diseases and cancer. HCW9201 is a reagent that supports enhanced anti-tumor activity and contributes to treatment resilience in the adverse tumor microenvironment. The Company’s lead product candidate for its autoimmune program is HCW9302, which is subcutaneously injectable, first-in-kind interleukin-2 (“IL-2”) fusion molecule constructed using the Company’s TOBI™ platform technology. HCW9302 is currently being evaluated in a Phase 1 clinical study in patients with alopecia areata, which initiated in November 2025 (NCT07049328). The Company has identified two preclinical lead product candidates which are currently in IND-enabling stage for internal development constructed with its proprietary TRBC drug discovery and development platform. HCW11-018b (“Big BiTE”) is a tetra-valent T-cell engager designed to address shortfalls of bi-specific T-cell engagers (“BiTE”) related to manufacturability, safety profile, and ability to treat a wide spectrum of solid tumors. HCW11-040 is a pembrolizumab-based, tetra-valent immune checkpoint inhibitor. To improve efficacy, HCW11-040 is equipped with other moieties in addition to pembrolizumab which neutralizes the immunosuppressive cytokine, TGF-β, and activates effector immune cell responses. 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 and include: the Company’s ability to develop new immunotherapeutic treatments for non-oncology or oncology indications; timing of initiation of studies for age-related and autoimmune diseases; the Company’s ability to continue as a going concern and that after considering the elements of the Company’s financing plan that were probable to occur within a year of the date of issuance, the Company concluded that substantial doubt was not alleviated in its going concern analysis; the Company’s cash runway; the effectiveness of HCW9302 in clinical trials and data readouts against autoimmune conditions; the Company’s ability to license its preclinical molecule(s); the ability of the Company to enter into a corporate partnership to market commercial-ready reagents; the actual success and potency of the Company’s TRBC fusion molecules;; the actual success and potency of pembrolizumab-based TRBC fusion molecules;; the ability of the Company’s partner to develop, manufacture and undergo clinical trials with HCW11-006; the Company’s future capital-raising plans and ability to continue with clinical development efforts until they are achieved, if at all; and Company’s ability to pay legal fees incurred in connection with the arbitration with ImmunityBio and its affiliates. 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. 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 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. [email protected]
Investor releaseQuarter not tagged2026-03-16HCW Biologics Announces Positive Research Results for CAR-T Cell Therapy Manufactured Utilizing Its Commercial-Ready Proprietary Compound, HCW9206, Published in Science Advances
GlobeNewswire
HCW Biologics Announces Positive Research Results for CAR-T Cell Therapy Manufactured Utilizing Its Commercial-Ready Proprietary Compound, HCW9206, Published in Science Advances
Commercialization ready compound supports a new method of generating highly functional human CAR-T cells for treating infectious diseases and cancer In experimental models, human CAR-T cells manufactured using HCW9206 showed strong anti-tumor activity in leukemia and enhanced antiviral potency in HIV suggesting potential for curative outcomes Employing HCW9206 as a manufacturing reagent may lower the cost of CAR-T manufacturing MIRAMAR, Fla., March 16, 2026 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (“HCWB” or the “Company”) (NASDAQ: HCWB), is a U.S.-based commercial- and clinical-stage biopharmaceutical company focused on supporting or developing novel immunotherapies to treat autoimmune diseases, cancer, and senescence-associated dysplasia, announced today results of groundbreaking research studies, published in the peer-reviewed, high-impact journal, Science Advances (Cole et al., “IL-7/IL-15/IL-21 cytokine-fusion scaffold generates highly functional CAR-T cells enriched in long-lived T memory stem cells” Science Advances, 13 Mar 2026, Vol 12, Issue 11). These studies were led by Harris Goldstein, M.D., professor of pediatrics and of microbiology & immunology and director of the Einstein-Rockefeller-CUNY-Mount Sinai Center for AIDS Research and his team of Albert Einstein College of Medicine scientists, most notably Erin Cole, M.S., a graduate student in the Goldstein laboratory. The study results demonstrated that HCW9206, the Company’s proprietary and commercial-stage multi-cytokine fusion protein reagent, provides a revolutionary approach to generate chimeric T-cell receptor - T cells (“CAR-Ts”) for immunotherapy with increased function in a cost-effective manner. HCW9206, a first-in-class cytokine-scaffold-based platform, enables production of more potent CAR-T-based immunotherapies by generating a CAR-T population which is highly functional and markedly enriched for long-live T-memory stem cells (Tscm). Utilizing HCW9206 as a manufacturing strategy may be broadly applicable to increase persistence and functionality of CAR-Ts. Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, stated, “HCW9206 is a novel compound that enables a single molecule to deliver synergistic signals from three different immune-stimulatory cytokines. It is versatile and has shown activity in the creation of memory-like NK-cells for cell-based therapy against cance…Read full documentShow less
Commercialization ready compound supports a new method of generating highly functional human CAR-T cells for treating infectious diseases and cancer In experimental models, human CAR-T cells manufactured using HCW9206 showed strong anti-tumor activity in leukemia and enhanced antiviral potency in HIV suggesting potential for curative outcomes Employing HCW9206 as a manufacturing reagent may lower the cost of CAR-T manufacturing MIRAMAR, Fla., March 16, 2026 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (“HCWB” or the “Company”) (NASDAQ: HCWB), is a U.S.-based commercial- and clinical-stage biopharmaceutical company focused on supporting or developing novel immunotherapies to treat autoimmune diseases, cancer, and senescence-associated dysplasia, announced today results of groundbreaking research studies, published in the peer-reviewed, high-impact journal, Science Advances (Cole et al., “IL-7/IL-15/IL-21 cytokine-fusion scaffold generates highly functional CAR-T cells enriched in long-lived T memory stem cells” Science Advances, 13 Mar 2026, Vol 12, Issue 11). These studies were led by Harris Goldstein, M.D., professor of pediatrics and of microbiology & immunology and director of the Einstein-Rockefeller-CUNY-Mount Sinai Center for AIDS Research and his team of Albert Einstein College of Medicine scientists, most notably Erin Cole, M.S., a graduate student in the Goldstein laboratory. The study results demonstrated that HCW9206, the Company’s proprietary and commercial-stage multi-cytokine fusion protein reagent, provides a revolutionary approach to generate chimeric T-cell receptor - T cells (“CAR-Ts”) for immunotherapy with increased function in a cost-effective manner. HCW9206, a first-in-class cytokine-scaffold-based platform, enables production of more potent CAR-T-based immunotherapies by generating a CAR-T population which is highly functional and markedly enriched for long-live T-memory stem cells (Tscm). Utilizing HCW9206 as a manufacturing strategy may be broadly applicable to increase persistence and functionality of CAR-Ts. Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, stated, “HCW9206 is a novel compound that enables a single molecule to deliver synergistic signals from three different immune-stimulatory cytokines. It is versatile and has shown activity in the creation of memory-like NK-cells for cell-based therapy against cancer, and now we also discovered it has the potential to enhance the production of CAR-T therapies as a promising novel reagent to replace the current industry-standard method that relies on anti-CD3/anti-CD28/IL-2-based approaches. An approach that employs HCW9206 as a reagent is more streamlined and may lower the cost of CAR-T manufacturing. Equally important, based on experimental models, HCW9206 has shown improvement in functional activities and persistence of CAR-Ts following adoptive transfer, a goal the industry has been trying to achieve for the last decade.” Functional persistence of CAR-Ts is limited by conventional and costly manufacturing methods utilizing anti-CD3/CD28 (αCD3/28)/IL-2 stimulation, which generates terminally differentiated and shorter-lived CAR-Ts. Utilizing HCW9206 during the manufacture of CAR-Ts synergizes the effects of IL-7, IL-15 and IL-21 to promote the generation of a CAR-T cell product with a diverse mix of T cell subsets that exhibit a combination of Tscm self-renewal capacity and enhanced T cell effector function, likely from the TEM population. In this pivotal publication, the authors show how HCW9206, when used in the manufacture of CAR-T, stimulates proliferation of CD8+T cells, particularly those within the Tscm subset. As a result, HCW9206 was shown to generate CAR-Ts without requiring αCD3/28/IL-2 activation which are highly enriched in long-lived Tscm (50% or more) and display potent activity across distinct disease experimental models, namely, HIV-1 or B-cell leukemia. In preclinical studies, CAR-Ts manufactured using HCW9206 were significantly superior compared to CART-Ts manufactured using standard methods employing anti-CD3/anti-CD28 and IL-2 reagents for CAR lentiviral transduction and subsequent expansion and persistence of highly active human CAR-Ts. While there is still a need to confirm in clinical studies, this research suggests that CAR-T cells produced with HCW9206 may be a more effective and long-lasting CAR-T cell immunotherapy than conventional CAR-T produced using αCD3/28/IL-2. In this article, the authors demonstrate in a humanized mouse model of HIV-1 infection utilizing T cells from people living with HIV (PLWH), HCW9206 enabled generation of duoCAR-T cells composed of a highly enriched Tscm population, which supported long-term persistence and functional activity in vivo, along with the effector memory T cells (TEM) population capable of providing immediate and potent HIV-1 suppression. Utilizing HCW9206 in the manufacture of CAR-Ts may advance HIV immunotherapy by introducing a new strategy that may produce functionally persistent product, thereby extending the lifespan of anti-HIV CAR-T therapy in PLWH and potentially enabling a functional cure. The authors also show how anti-cancer CD19-CAR-T cells manufactured using HCW9206 exhibited a greater capacity to mount a protective proliferative response in vivo, as indicated by the effective suppression of tumor cell expansion after rechallenging with CD19+ cancer cells by HCW9206-generated CD19-CAR-T cells compared to the (αCD3/28)-generated CD19-CAR-Tcells in multiple humanized animal models. The authors of this article also reported that antigen stimulation of duoCAR-T produced with HCW9206 significantly upregulated the expression of SATBI1 (special AT-rich sequence-binding protein 1), a gene previously reported to be a key determinant in linage commitment through chromatin reorganization. Specifically, SATB1 has been shown to be a key regulator of CD8+ T-cell quiescence and stemness, as well as promoting early effector cell expansion and differentiation to support both effector responses and long-term T-cell persistence. Taken together, these data demonstrate that manufacturing human T cells with HCW9206 produces HIV- and CD19-specific CAR-T cells that are highly enriched for the Tscm memory phenotype, as well as human effector T cells capable of maintaining suppression of HIV and leukemic cell proliferation in experimental models. Therefore, generating human CAR-T cells utilizing HCW9206 could provide a new, improved, and highly scalable method for generating human CAR-T cells to treat patients with infectious disease and cancer and replace standard CAR-T cell production using αCD3/28 activation. This has widespread implications for the generation of more robust CAR-T cell-based immunotherapies with the potential to improve CAR-T cell functional persistence and efficacy for treatment of HIV and cancer. The authors are Natalia Valderrama Pena, B.S., Niraj Shrestha, Ph.D., and Hing Wong, Ph.D. at HCW Biologics; along with Sara Lamcaj, Ph.D., Agnes Sydenstricker, B.S., Adilyn Voss, B.S., Christopher Hiner, Ph.D., and Jian Hua Zheng, B.S., Harris Goldstein, M.D. at Albert Einstein College of Medicine; Ying Xiong, Ph.D., Zhongyu Zhu, Ph.D., and Boro Dropulić, Ph.D., at Caring Cross; and Cheng Cheng Zhang, Ph.D. at University of Texas Southwestern Medical Center, Dallas, TX. Links for Articles Referenced in Press Release: IL-7/IL-15/IL-21 cytokine-fusion scaffold generates highly functional CAR T cells enriched in long-lived T memory stem cells | Science Advances A “Prime and Expand” strategy using the multifunctional fusion proteins to generate memory-like NK cells for cell therapy | Cancer Immunology, Immunotherapy | Springer Nature Link About HCW Biologics: HCW Biologics Inc. (“HCWB” or the “Company”) (NASDAQ: HCWB) is a U.S.-based commercial- and clinical-stage biopharmaceutical company focused on supporting or developing novel immunotherapies to treat 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. Chronic inflammation, including inflammaging, is believed to be a significant contributing factor to the cause conditions that diminish healthspan, including many types of cancer, autoimmune diseases, and neurodegenerative diseases, as well as indications, such as bronchopulmonary dysplasia, that impact quality-of-life that are not life-threatening. HCW9206, the Company’s commercial asset, is a commercialization-ready compound that supports a new method of generating highly functional human CAR-T cells for treating infectious diseases and cancer. The Company’s lead product candidate for its autoimmune program is HCW9302, which is subcutaneously injectable, first-in-kind interleukin-2 (“IL-2”) fusion molecule constructed using the Company’s TOBI™ platform technology. HCW9302 is currently being evaluated in a Phase 1 clinical study in patients with alopecia areata, which initiated in November 2025 (NCT07049328). The Company has identified two preclinical lead product candidates which are currently in IND-enabling stage for internal development constructed with its proprietary TRBC drug discovery and development platform. HCW11-018b (“Big BiTE”) is a tetra-valent T-cell engager designed to address shortfalls of bi-specific T-cell engagers (“BiTE”) related to manufacturability, safety profile, and ability to treat a wide spectrum of solid tumors. HCW11-040 is a pembrolizumab-based, tetra-valent immune checkpoint inhibitor. To improve efficacy, HCW11-040 is equipped with other moieties in addition to pembrolizumab which neutralizes the immunosuppressive cytokine, TGF-β, and activates effector immune cell responses. 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 and include, the ability and efficacy of HCW9206 for generating CAR-T’s for immune cell therapy with increased persistence and functionality at a lower cost; the ability of HCW9206 preclinical studies to translate into human trials to activate long-lived T-memory stem cells (“Tscm”) cells in patients; the ability of HCW9206 to improve long-term survival of disease- specific CAR-Ts following adoptive transfer and enable sustained suppression of malignancies, chronic infections and autoimmune diseases; the availability for a license and supply HCW9206 for commercial use for certain indications. 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. 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 28, 2025 and in other filings filed from time to time with the SEC. Company Contact: Peter Rhode, PhD. Chief Scientific Officer and Vice President Clinical Operations HCW Biologics Inc. [email protected]
Investor releaseQuarter not tagged2025-11-15HCW Biologics Reports Third Quarter 2025 Business Highlights and Financial Results
GlobeNewswire
HCW Biologics Reports Third Quarter 2025 Business Highlights and Financial Results
MIRAMAR, Fla., Nov. 14, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and diseases, today reported financial results and recent business highlights for its third quarter ended September 30, 2025. The Company anticipates dosing the first patient in a Phase 1 clinical study (NCT07049328) to evaluate HCW9302 in patients with an autoimmune disease in the fourth quarter of 2025. HCW9302 is the Company’s lead product candidate for its clinical program to develop treatments for autoimmune diseases and inflammatory conditions. HCW9302 is a subcutaneously injectable, first-in-kind interleukin 2 (“IL-2”) fusion molecule constructed using the Company’s legacy TOBI™ platform technology. IL-2, the active component of HCW9302, is the cytokine in humans and other vertebrates responsible for maintaining the proper numbers and functions of regulatory T (“Treg”) cells in the body. Treg cells control excessive inflammation caused by other immune cells, which is the etiology of autoimmune diseases. The breakthrough discovery of the critical function of Treg cells by Drs. Mary E. Brunkow, Fred Ramsdell and Shimon Sakaguchi was recently acknowledged with the 2025 Nobel Prize in Physiology or Medicine for their groundbreaking work concerning Treg cells, which discovery was that these cells are the immune system’s security guards which prevent immune cells from attacking our own body. Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer said, “The goal of our Phase 1 clinical study for HCW9302 is to establish the safe dose that effectively increases Treg cell activity in patients with an autoimmune disease. Once we achieve this objective, we hope to rapidly expand clinical development of HCW9302 in Phase 2 studies in patients with alopecia areata as well as other autoimmune diseases and inflammatory conditions.” Business Highlights Business Development Transactions The Company has launched its search for a strong commercial partner for the clinical development of its T-cell engager (“TCE”) compounds. These compounds are designed to address shortfalls in the first generation products. The Company has created TCE compounds that can target cancer antigens…Read full documentShow less
MIRAMAR, Fla., Nov. 14, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and diseases, today reported financial results and recent business highlights for its third quarter ended September 30, 2025. The Company anticipates dosing the first patient in a Phase 1 clinical study (NCT07049328) to evaluate HCW9302 in patients with an autoimmune disease in the fourth quarter of 2025. HCW9302 is the Company’s lead product candidate for its clinical program to develop treatments for autoimmune diseases and inflammatory conditions. HCW9302 is a subcutaneously injectable, first-in-kind interleukin 2 (“IL-2”) fusion molecule constructed using the Company’s legacy TOBI™ platform technology. IL-2, the active component of HCW9302, is the cytokine in humans and other vertebrates responsible for maintaining the proper numbers and functions of regulatory T (“Treg”) cells in the body. Treg cells control excessive inflammation caused by other immune cells, which is the etiology of autoimmune diseases. The breakthrough discovery of the critical function of Treg cells by Drs. Mary E. Brunkow, Fred Ramsdell and Shimon Sakaguchi was recently acknowledged with the 2025 Nobel Prize in Physiology or Medicine for their groundbreaking work concerning Treg cells, which discovery was that these cells are the immune system’s security guards which prevent immune cells from attacking our own body. Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer said, “The goal of our Phase 1 clinical study for HCW9302 is to establish the safe dose that effectively increases Treg cell activity in patients with an autoimmune disease. Once we achieve this objective, we hope to rapidly expand clinical development of HCW9302 in Phase 2 studies in patients with alopecia areata as well as other autoimmune diseases and inflammatory conditions.” Business Highlights Business Development Transactions The Company has launched its search for a strong commercial partner for the clinical development of its T-cell engager (“TCE”) compounds. These compounds are designed to address shortfalls in the first generation products. The Company has created TCE compounds that can target cancer antigens and CD3 activation of effector T cells while simultaneously reducing the immunosuppression in tumor microenvironment. Such immunosuppression could play a pivotal role in reducing effector T-cell infiltration and anti-tumor efficacy in solid tumors. Financing Transactions During the three months ended September 30, 2025, the Company issued 475,000 shares of Common Stock for gross proceeds of $2.2 million utilizing the Company’s Standby Equity Purchase Agreement. Preclinical and Clinical Development Results The Company has successfully opened two clinical sites that are actively screening patients to participate in a first-in-human Phase 1 dose escalation clinical trial to evaluate one of its lead drug candidates, HCW9302, in patients with alopecia areata. The Company expects to dose the first patient in this clinical trial in the fourth quarter of 2025. Alopecia areata is a common autoimmune disease in humans that currently has no curative FDA approved treatments. It causes sudden hair loss and can have a significant negative impact on patients’ quality of life and psychological health. The National Alopecia Areata Foundation estimates approximately 160 million people worldwide and 7 million people in the United States have alopecia areata. The condition affects about 2% of the global population at some point in their lifetime. HCW Biologics showcased data for its lead engager HCW11-018b highlighting the uniqueness and advantages of the Company’s second-generation TCE program over the first-generation products at SITC. HCW11-018b is a tetra-valent construct that activates tumor-infiltrated exhausted T cells while addressing the immunosuppressive tumor microenvironment. It has broad coverage for human solid tumor indications by targeting tissue factor, with high potency and precision, shown in xenograft models including the Patient-Derived Xenograft (PDX) tumor model. HCW Biologics also presented data for its lead product candidate in the Company’s second-generation immune checkpoint inhibitor program at SITC. HCW11-040 is a proprietary TRBC-pembrolizumab-based immune checkpoint inhibitor, which the Company considers as its franchise immunotherapeutic compound for internal clinical development. It is a unique combination of cytokines in multi-functional fusion protein molecule that exhibits the ability to expand progenitor exhausted T cells, or TPEX cells, without inducing a cytokine storm in preclinical studies. TPEX cells, located in the draining lymph nodes and tumors of the patients, have been implicated as the primary responders to ICI therapy. HCW11-040 in undergoing IND-enabling studies to prepare for clinical trials for evaluation in the treatment of solid tumors. Third Quarter 2025 Financial Results Revenues: Revenues for the three months ended September 30, 2024 and 2025 were $426,423 and $15,606, respectively. Revenues for the nine months ended September 30, 2024 and 2025 were $2.2 million and $27,222, respectively. Historically, revenues have been derived exclusively from the sale of licensed molecules to the Company’s licensee, Wugen. In the nine months ended September 30, 2025, the Company agreed to a one-year suspension of the Wugen License Agreement. Research and development (R&D) expenses: R&D expenses for the three months ended September 30, 2024 and 2025 were $1.2 million and $1.4 million, respectively, an increase of $271,334, or 18%. R&D expenses for the nine months ended September 30, 2024 and 2025 were $5.3 million and $4.1 million, respectively, a decrease of $1.2 million, or 23%. R&D expenses in the nine months ended September 30, 2024 were comparatively higher than the same period in 2025 due to expenses incurred for the manufacture of a high-expressing line of HCW9101, an element needed in the manufacture of HCW9302, the Company’s clinical-stage molecule. Such activities were completed in 2024. General and administrative (G&A) expenses: G&A expenses for the three months ended September 30, 2024 and 2025 were $1.6 million and $1.9 million, respectively, an increase of $251,537, or 15%. G&A expenses for the nine months ended September 30, 2024 and 2025 were $4.8 million and $6.2 million, respectively, an increase of $1.4 million, or 29%. The increase in G&A expenses in 2025 was primarily due to salaries and benefits and professional fees related to audit services, tax and other advisory services, as well as required activities to remain in compliance with SEC regulations and Nasdaq listing rules. Legal expenses (recoveries), net: Legal expenses and recoveries, net represent the legal fees that the Company incurred for an Arbitration which held its hearing in May 2024, was settled on July 13, 2024, and was dismissed on December 24, 2024. Legal expenses (recoveries), net for the three months ended September 30, 2024 and 2025 were $1.0 million and $6,006, respectively. Legal expenses (recoveries), net for the nine months ended September 30,2024 and 2025 were $15.8 million and a contra expense of ($1.6) million, respectively. In January 2025, the Company received a $2.0 million insurance reimbursement that was paid directly to the law firm involved in representing Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, in the Arbitration. The Company is engaged in discussions with the law firms involved with this matter to arrange a reasonable payment plan with respect to $12.1 million legal fees which remain unpaid. Net loss: Net loss for the three months ended September 30, 2024 and 2025 was $3.9 million and $4.6 million, respectively. Net loss for the nine months ended September 30, 2024 and 2025 was $26.7 million and $8.7 million, respectively. Financial Guidance As of September 30, 2025, 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, that were probable and likely to be implemented within the next year to determine if financing activities currently underway are sufficient to mitigate the substantial doubt in our going concern analysis. 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. An important part of the Company’s future financing plans is the ability to access the public markets for the sale of securities. This requires the Company’s compliance with all Nasdaq Listing Rules, and it is currently deficient in meeting the requirements of Listing Rule 5550(b)(1), or the Equity Rule, related to the minimum requirements to maintain a $2.5 million balance in stockholders’ equity. On October 13, 2025, a Nasdaq Hearings Panel granted the Company’s request for continued listing on the Exchange, subject to, among other things, that the Company is in compliance with the Equity Rule by December 31, 2025. About HCW Biologics HCW Biologics Inc. (NASDAQ: HCWB) is a clinical-stage biopharmaceutical company developing proprietary immunotherapies to treat diseases promoted by chronic inflammation, especially age-related and senescence-associated diseases. The Company’s immunotherapeutics represent a new class of drugs that it believes have the potential to fundamentally change the treatment of cancer and many other diseases and conditions that are promoted by chronic inflammation — and in doing so, improve patients’ quality of life and potentially extend longevity. Chronic inflammation, including inflammaging, is believed to be a significant contributing factor to senescence-associated diseases and conditions that diminish healthspan, including many types of cancer, autoimmune diseases, and neurodegenerative diseases, as well as many indications that impact quality-of-life that are not life-threatening. The Company’s lead product candidate, HCW9302, was developed using the Company’s legacy TOBI™ (Tissue factOr-Based fusIon) platform. The Company has created another drug discovery technology, the TRBC platform, which is not based on Tissue Factor. The TRBC platform has the capability to construct immunotherapeutics that not only activate and target immune responses but are also equipped with receptors that specifically target cancerous or infected cells. This platform is a versatile scaffold that enables the creation of multiple classes of immunotherapeutic compounds: Class I: Multi-Functional Immune Cell Stimulators; Class II: Second-Generation Immune Checkpoint Inhibitors; Class III: Multi-Specific Targeting Fusions and Enhanced Immune Cell Engagers. These novel immunotherapeutics are being developed for treatment of a wide range of disease indications, including oncology, autoimmune diseases, and improving quality of life conditions. The Company has constructed over 50 molecules using the TRBC platform. HCW9302 is the lead product candidate for the Company’s clinical development program for autoimmune diseases and other proinflammatory conditions. The Company expects to dose the first patient in a Company-sponsored, multi-center Phase 1 clinical trial (NCT07049328) to evaluate HCW9302 in an autoimmune disease in the fourth quarter of 2025. The IND-enabling process is underway for three TRBC-based molecules which were selected as the lead product candidates for other clinical development programs in cancer and age-related diseases based on promising preclinical data. The Company has two licensing programs in which it has licensed exclusive rights for some of its proprietary molecules. 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 and include: the Company’s ability to develop new immunotherapeutic treatments for non-oncology or oncology indications; timing of initiation of studies for age-related and autoimmune diseases; the Company’s ability to continue as a going concern and that after considering the elements of the Company’s financing plan that were probable to occur within a year of the date of issuance, the Company concluded that substantial doubt was not alleviated in its going concern analysis; the Company’s cash runway; the Company’s expectations regarding future purchases of licensed molecules by Wugen; the Company’s ability to license its preclinical molecule(s); the initiation of patient enrollment for a clinical trial to evaluate HCW9302; the actual success and potency of the Company’s TCE-based TRBC fusion molecules; the ability of the Company’s TCE’s to target cancer antigens, activate effector T cells, and reduce immunosuppression in the tumor microenvironment;; effectiveness of the Company’s TCEs in treatment of solid tumors and pancreatic cancers; the actual success and potency of pembrolizumab-based TRBC fusion molecules; the ability of HCW11-040 to expand TPEX cells more effectively and expand and activate PBMCs more effectively; the Company’s future capital-raising plans and ability to continue with clinical development efforts until they are achieved, if at all; and Company’s ability to pay legal fees incurred in connection with the arbitration with ImmunityBio and its affiliates. 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. 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 28, 2025 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. [email protected]
Investor releaseQuarter not tagged2025-09-09HCW Biologics Reports Positive Results from Non-Human Primate Study for Its Proprietary Second-Generation T-Cell Engager Program
GlobeNewswire
HCW Biologics Reports Positive Results from Non-Human Primate Study for Its Proprietary Second-Generation T-Cell Engager Program
HCW Biologics conducted investigative study to show safe dose levels of its lead drug candidate in non-human primates that were well tolerated at a level significantly higher than the identified efficacious dose level Program has addressed key challenges for first generation T-cell engagers related to manufacturability, preclinical safety profile, and ability to treat a wide spectrum of solid tumors Program is positioned for a potential high value corporate partnership MIRAMAR, Fla., Sept. 09, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”), (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and age-related diseases, announced today that its scientists have successfully developed second-generation, tissue factor-targeting T-cell engagers against solid tumors, particularly for pancreatic cancer and glioblastoma, constructed with its novel proprietary TRBC product discovery and development platform technology. T-cell engagers (“TCEs”) revolutionized the immunotherapeutic approach against cancer since the first indication was approved for Amgen’s BLINCYTO® (blinatumomab) in 2014. Currently, the U.S. Food and Drug Administration (“FDA”) and other regulatory agencies have approved eight TCEs to be used to treat 11 indications. Even with a very limited number of approved indications, approved TCEs are currently generating multi-billion-dollar annual sales. As the current FDA-approved T cell engagers reshape the landscape of cancer therapy, numerous high-value partnership deals between major pharmaceutical companies and biotech companies have been reported in the past two years. These partnerships have likely been driven by TCE’s potential in both oncology and autoimmune diseases and the majority of these deals were based on preclinical TCE programs. Although there has been success in the development of TCE therapy, first generation TCEs continue to face a number of significant challenges such as antigen selection, efficacy for solid tumors, tolerability, safety, and complex manufacturing processes. HCW Biologics believes its second-generation TCEs could alleviate such shortfalls. The Company has constructed TCEs that have shown in preclinical studies to not only target cancer antigens and C…Read full documentShow less
HCW Biologics conducted investigative study to show safe dose levels of its lead drug candidate in non-human primates that were well tolerated at a level significantly higher than the identified efficacious dose level Program has addressed key challenges for first generation T-cell engagers related to manufacturability, preclinical safety profile, and ability to treat a wide spectrum of solid tumors Program is positioned for a potential high value corporate partnership MIRAMAR, Fla., Sept. 09, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”), (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and age-related diseases, announced today that its scientists have successfully developed second-generation, tissue factor-targeting T-cell engagers against solid tumors, particularly for pancreatic cancer and glioblastoma, constructed with its novel proprietary TRBC product discovery and development platform technology. T-cell engagers (“TCEs”) revolutionized the immunotherapeutic approach against cancer since the first indication was approved for Amgen’s BLINCYTO® (blinatumomab) in 2014. Currently, the U.S. Food and Drug Administration (“FDA”) and other regulatory agencies have approved eight TCEs to be used to treat 11 indications. Even with a very limited number of approved indications, approved TCEs are currently generating multi-billion-dollar annual sales. As the current FDA-approved T cell engagers reshape the landscape of cancer therapy, numerous high-value partnership deals between major pharmaceutical companies and biotech companies have been reported in the past two years. These partnerships have likely been driven by TCE’s potential in both oncology and autoimmune diseases and the majority of these deals were based on preclinical TCE programs. Although there has been success in the development of TCE therapy, first generation TCEs continue to face a number of significant challenges such as antigen selection, efficacy for solid tumors, tolerability, safety, and complex manufacturing processes. HCW Biologics believes its second-generation TCEs could alleviate such shortfalls. The Company has constructed TCEs that have shown in preclinical studies to not only target cancer antigens and CD3 activation of effector T cells, but also simultaneously reduce immunosuppression in the tumor microenvironment. Reports have shown that such immunosuppression plays a pivotal role in reducing effector T-cell infiltration and anti-tumor efficacy in solid tumors. The Company’s two lead TCEs target tumor-expressed tissue factor and mesothelin, and its lead product candidates exhibit potent and antigen-specific anti-pancreatic cancer activities both in vitro and in humanized mouse models through subcutaneous injections. In a recently completed non-human-primate safety study, the Company demonstrated that its subcutaneously administered anti-tissue factor T-cell engager was well tolerated at the efficacious or significantly higher dose levels and promoted the effector T cells. There was no evidence that it induced either overt toxicity despite the presence of tissue factor on various organs and tissues, or cytokine release syndrome, a common and serious side effect of TCE therapy. Tissue factor is an approved cancer therapeutic target as evidenced by the use of Pfizer’s TIVDAK® (tisotumab vedotin-tftv) for recurrent or metastatic cervical cancer. TIVDAK® is an antibody drug conjugate targeting tissue factor expressed on tumor cells. There is vast evidence showing that tissue factor is highly upregulated by a variety of aggressive solid tumors such as glioblastoma, pancreatic, breast, and ovarian cancer. Tissue factor upregulation is associated with tumor aggressiveness and resistance to chemotherapy, radiation, and immune checkpoint inhibitor therapies in the treatment of these solid tumors. With the ability to target tissue factor, the Company believes that its lead tissue factor targeting TCE has the potential to treat a wide spectrum of hard-to-treat solid tumors as monotherapy or in combination with standard-of-care therapies. Finally, a streamlined, simple, and cost-effective manufacturing process has also been developed for the Company’s second-generation, TRBC-based TCEs. Dr. Hing C. Wong, the Company’s Founder and CEO, stated, “We are pleased to report that our proprietary TRBC platform was used to create second-generation T-cell engagers that we believe are effective, well-tolerated, and cost-effective that target difficult-to-treat solid tumors while managing tumor mediated immunosuppression. We have constructed a strong immunotherapeutic portfolio consisting of T-cell engagers with other antigen specificities using our proprietary TRBC technology.” He continued, “Our preclinical studies show that our lead second-generation TCE could remarkably shrink the well-established tumors in mice models, and there was 100% survival among tumor-bearing mice treated with our TRBC-based TCE product candidate, whereas none of the untreated mice survived. We believe our approach could expand the number of indications that can be treated with our second-generation TCEs, such as autoimmune diseases and quality-of-life conditions, in addition to enhancing the healthspan for patients suffering with a wide spectrum of solid tumors, especially pancreatic cancer and glioblastoma.” Dr. Wong concluded, “Since the development of a TCE is complex and requires a substantial amount of capital, our strategy is to develop our lead product candidate in partnership with a financially strong corporate partner. I am very excited that we have achieved major milestones for evaluating this anti-tissue factor T-cell engager’s preclinical safety profile and its ability to target solid tumors while managing tumor mediated immunosuppression. These findings provide the necessary data to initiate discussions with major players who may be interested in building their T-cell engager portfolio with our lead TCE and other second-generation TCE product candidates in our portfolio.” BLINCYTO® and TIVDAK® are registered trademarks of Amgen and Seagen Inc. (Pfizer Inc.), respectively, and these companies are not affiliated with HCWB. About HCW Biologics: HCW Biologics Inc. (NASDAQ: HCWB) is a clinical-stage biopharmaceutical company developing proprietary immunotherapies to treat diseases promoted by chronic inflammation, especially age-related and senescence-associated diseases. The Company’s immunotherapeutics represent a new class of drugs that it believes have the potential to fundamentally change the treatment of cancer and many other diseases and conditions that are promoted by chronic inflammation — and in doing so, improve patients’ quality of life and potentially extend longevity. Chronic inflammation, including inflammaging, is believed to be a significant contributing factor to senescence-associated diseases and conditions that diminish healthspan, including many types of cancer, autoimmune diseases, and neurodegenerative diseases, as well as many indications that impact quality-of-life that are not life-threatening. The Company’s lead product candidate, HCW9302, was developed using the Company’s legacy TOBI™ (Tissue factOr-Based fusIon) platform. The Company has created another drug discovery technology, the TRBC platform, which is not based on Tissue Factor. The TRBC platform has the capability to construct immunotherapeutics that not only activate and target immune responses but are also equipped with receptors that specifically target cancerous or infected cells. This platform is a versatile scaffold that enables the creation of multiple classes of immunotherapeutic compounds: Class I: Multi-Functional Immune Cell Stimulators; Class II: Second-Generation Immune Checkpoint Inhibitors; Class III: Multi-Specific Targeting Fusions and Enhanced Immune Cell Engagers. These novel immunotherapeutics are being developed for treatment of a wide range of disease indications, including oncology, autoimmune diseases, and improving quality of life conditions. The Company has constructed over 50 molecules using the TRBC platform. Further preclinical evaluation studies are currently being conducted for these molecules the Company has selected based on promising preclinical data. The Company has two licensing programs in which it has licensed exclusive 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 and include, the actual success and potency of the Company’s TCE-based TRBC fusion molecules; the ability of the Company’s TCE’s to target cancer antigens, CD3 activation of effector T cells, and reduce immunosuppression in the tumor microenvironment; the ability of the Company’s TCEs to exhibit potent and antigen-specific anti-pancreatic cancer activities both in vitro and in humanized mouse models; or whether the Company’s TCEs are effective in treatment of solid tumors and pancreatic cancers. 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 28, 2025, the latest Form 10-Q filed with the SEC on August 18, 2025 and in other filings filed from time to time with the SEC. Company Contact: Dr. Peter Rhode Chief Scientific Officer and Vice President of Clinical Operations HCW Biologics Inc. [email protected]
Investor releaseQuarter not tagged2025-08-19HCW Biologics Reports Second Quarter 2025 Business Highlights and Financial Results
GlobeNewswire
HCW Biologics Reports Second Quarter 2025 Business Highlights and Financial Results
MIRAMAR, Fla., Aug. 18, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between inflammation and age-related diseases, today reported financial results and recent business highlights for its second quarter ended June 30, 2025. On May 15, 2025, the Company closed an equity offering with gross proceeds of $5.0 million with a single institutional investor. Dr. Hing Wong, Founder and CEO, stated, “We are pleased to have completed a successful $5.0 million equity offering in a challenging market without using a highly structured deal. This funding will be used to open clinical sites for our Phase 1 clinical trial to evaluate HCW9302 in an autoimmune disorder.” Dr. Wong continued, “Our new round of financing will provide funding for critical studies to complete the research package for our business development campaign to identify a licensing partner to commercialize our Immune-Cell Engagers, including T-Cell Engagers, which we created using our novel TRBC drug discovery and development platform.” Business Highlights Business Development Transactions On May 30, 2025, WY Biotech ended its due diligence period and formally accepted the technical report delivered by the Company on May 13, 2025. In order to accommodate WY Biotech’s timing in finalizing legally binding agreements with its CDMO and lead investor, the Company and WY Biotech agreed to extend the latest date for payment of the $7.0 million license fee to September 30, 2025. On May 29, 2025, after recognizing over $16.0 million in revenue from the Wugen License Agreement signed in 2020, the Company agreed to a one-year suspension of the Wugen License Agreement, during which time the Company may seek alternative licensing programs for HCW9206. The Company is actively negotiating with several major biologics manufacturing companies interested in licensing the molecule as a reagent to use in the manufacture of CAR-T products. HCW9206 represents a novel strategy for CAR-T cell production with the advantage of generating a large population of CAR-Ts with a stem cell-like memory T cell phenotype, which is expected to enhance the persistence of CAR-Ts in patients. The Company has launched a search for a strong commercial…Read full documentShow less
MIRAMAR, Fla., Aug. 18, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between inflammation and age-related diseases, today reported financial results and recent business highlights for its second quarter ended June 30, 2025. On May 15, 2025, the Company closed an equity offering with gross proceeds of $5.0 million with a single institutional investor. Dr. Hing Wong, Founder and CEO, stated, “We are pleased to have completed a successful $5.0 million equity offering in a challenging market without using a highly structured deal. This funding will be used to open clinical sites for our Phase 1 clinical trial to evaluate HCW9302 in an autoimmune disorder.” Dr. Wong continued, “Our new round of financing will provide funding for critical studies to complete the research package for our business development campaign to identify a licensing partner to commercialize our Immune-Cell Engagers, including T-Cell Engagers, which we created using our novel TRBC drug discovery and development platform.” Business Highlights Business Development Transactions On May 30, 2025, WY Biotech ended its due diligence period and formally accepted the technical report delivered by the Company on May 13, 2025. In order to accommodate WY Biotech’s timing in finalizing legally binding agreements with its CDMO and lead investor, the Company and WY Biotech agreed to extend the latest date for payment of the $7.0 million license fee to September 30, 2025. On May 29, 2025, after recognizing over $16.0 million in revenue from the Wugen License Agreement signed in 2020, the Company agreed to a one-year suspension of the Wugen License Agreement, during which time the Company may seek alternative licensing programs for HCW9206. The Company is actively negotiating with several major biologics manufacturing companies interested in licensing the molecule as a reagent to use in the manufacture of CAR-T products. HCW9206 represents a novel strategy for CAR-T cell production with the advantage of generating a large population of CAR-Ts with a stem cell-like memory T cell phenotype, which is expected to enhance the persistence of CAR-Ts in patients. The Company has launched a search for a strong commercial partner for the clinical development of its T-cell engager compounds. The Company believes that its T-cell engagers target cancer antigens and CD3 activation of effector T cells while simultaneously reducing the immunosuppression in tumor microenvironment. Such immunosuppression could play a pivotal role in reducing effector T-cell infiltration and anti-tumor efficacy in solid tumors. Financing Transactions On May 15, 2025, the Company completed a $5.0 million offering with a single institutional investor for an aggregate of 671,140 units at a purchase price of $7.45 per unit priced at-the-market under Nasdaq rules. Each unit includes two warrants, which may be exercised to purchase common stock at $7.45 per share. On May 7, 2025, the Company extinguished $7.7 million of debt through restructuring or conversion to equity. As a result, the Company strengthened its balance sheet and completed an important element of its compliance plan with all Nasdaq Listing Rules. Clinical Development and Preclinical Results The Company remains on track to initiate the HCW9302 clinical trial in the third quarter of 2025. This trial is a first-in-human Phase 1 dose escalation clinical trial to evaluate one of its lead drug candidates, HCW9302, in patients with alopecia areata, a common autoimmune disease in humans that currently has no curative FDA approved treatments. The Company identified compounds created with the Company’s novel TRBC platform for clinical development: Second-Generation T-Cell Engagers and Second-Generation Immune Checkpoint Inhibitors. The Company’s T-cell engager compounds target tissue factor, which is a proven solid tumor antigen. The second-generation immune checkpoint inhibitors are the Company’s candidates as a potential gateway to the multi-billion-dollar immune checkpoint inhibitors product market. The Company has identified its pembrolizumab-based fusion molecule as its lead candidate because in preclinical IND-enabling studies this compound exhibits potent anti-pancreatic cancer activities. Second Quarter 2025 Financial Results Revenues: Revenues for the second quarters ended June 30, 2024 and 2025 were $618,854 and $6,550, respectively. Revenues for the six months ended June 30, 2024 and 2025 were $1.7 million and $11,615, respectively. Revenues were derived exclusively from the sale of licensed molecules to the Company’s licensee, Wugen. In the second quarter of 2025, the Company agreed to a one-year suspension of the Wugen License Agreement, during which time, the Company plans to identify a new corporate partner who wishes to license HCW9206. Research and development (R&D) expenses: R&D expenses for the second quarters ended June 30, 2024 and 2025 were $2.0 million and $1.2 million, respectively, a decrease of $802,362, or 40%. R&D expenses for the six months ended June 30, 2024 and 2025 were $4.2 million and $2.7 million, respectively, a decrease of $1.5 million, or 35%. R&D expenses were comparatively lower in 2025 primarily due to a decline in manufacturing and material and preclinical expenses. General and administrative (G&A) expenses: G&A expenses for the second quarters ended June 30, 2024 and 2025 were $1.6 million and $2.1 million, respectively, an increase of $501,828, or 31%. G&A expenses for the six months ended June 30, 2024 and 2025 were $3.2 million and $4.3 million, respectively, an increase of $1.1 million, or 36%. The increase in G&A expenses in 2025 was primarily related to an increase in fees for professional services, accretion of a fixed bonus payable upon Maturity Date to Secured Noteholders and insurance costs. Professional services include legal fees in the ordinary course of business, accounting advisors, auditing and tax services, facilities administrative costs, expenses related to maintaining our listing on Nasdaq and remaining in compliance with SEC filings, and other expenses. Legal expenses and recoveries, net: Legal expenses and recoveries, net represent the legal fees that the Company incurred for an Arbitration. On July 13, 2024, the parties entered into a Settlement Agreement and General Release, and the Arbitration and related Complaint were dismissed on December 24, 2024. For the three and six months ended June 30, 2024, preparations for the hearing and the hearing took place, along with subsequent negotiations for settlement, and the Company incurred legal fees of $10.4 million and $14.8 million, respectively. In January 2025, the Company received a $2.0 million insurance reimbursement that was paid directly to the law firm involved in representing Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, in the Arbitration. The Company is engaged in discussions with the law firms involved with this matter to arrange a reasonable payment plan with respect to $12.3 million legal fees which remain unpaid. Net loss: Net loss for the second quarters ended June 30, 2024 and 2025 were $15.3 million and $1.9 million, respectively. Net loss earnings for the six months ended June 30, 2024 and 2025 were $22.7 million and $4.1 million, respectively. Financial Guidance As of June 30, 2025, 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, that were probable and likely to be implemented within the next year to determine if financing activities currently underway are sufficient to mitigate the substantial doubt in our going concern analysis. 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 24, 2025, HCWB received formal notice from Nasdaq confirming that the Company has satisfied the requirements of Listing Rule 5550(b)(1) (the “Equity Rule”). On May 13, 2025, the Company received formal notice from Nasdaq that it regained compliance with the bid price requirement in Listing Rule 5550(a)(2), the public float requirement in Listing Rule 5550(a)(4), and the market value of publicly held shares requirement in Listing Rule 5550(a)(5). Therefore, the Company now meets all Nasdaq Capital Market listing requirements for continued listing, and these matters are closed. The Company was also notified that it will remain subject to a “Panel Monitor,” as that term is defined in Nasdaq Listing Rule 5815(d)(4)(B), for a period of one year from the date of the Nasdaq notice, through June 23, 2026. If, during the term of the Panel Monitor, the Company does not continue to remain in compliance with the Equity Rule, the Company will not be provided with the opportunity to submit a compliance plan for review by the Listing Qualifications Staff and must instead request a hearing before the Panel to address the deficiency, with such request staying any further action with respect to the Company’s listing on Nasdaq pending completion of the hearing process. About HCW Biologics HCW Biologics Inc. (NASDAQ: HCWB) is a clinical-stage biopharmaceutical company developing proprietary immunotherapies to treat diseases promoted by chronic inflammation, especially age-related and senescence-associated diseases. The Company’s immunotherapeutics represent a new class of drug that it believes have the potential to fundamentally change the treatment of cancer and many other diseases and conditions that are promoted by chronic inflammation — and in doing so, improve patients’ quality of life and possibly extend longevity. Chronic inflammation, including inflammaging, is believed to be a significant contributing factor to the cause for senescence-associated diseases and conditions that diminish healthspan, including many types of cancer, autoimmune diseases, and neurodegenerative diseases, as well as indications that impact quality-of-life that are not life-threatening. The Company’s lead product candidate, HCW9302, was developed using the Company’s legacy TOBI™ (Tissue factOr-Based fusIon) platform. The Company has created another drug discovery technology, the TRBC platform, which is not based on Tissue Factor. The TRBC platform has the capability to construct immunotherapeutics that not only activate and target immune responses but are also equipped with receptors that specifically target cancerous or infected cells. This platform is such a versatile scaffold that it enables the creation of multiple classes of immunotherapeutic compounds: Class I: Multi-Functional Immune Cell Stimulators; Class II: Second-Generation Immune Checkpoint Inhibitors; Class III: Multi-Specific Targeting Fusions and Enhanced Immune Cell Engagers. These novel immunotherapeutics can be used to treat a wide range of disease indications, including oncology, autoimmune diseases, and improving quality of life conditions. The Company has constructed over 50 molecules using the TRBC platform, including HCW11-002, HCW11-018 and HCW11-040. Further preclinical evaluation studies are currently being conducted for these three molecules the Company has selected based on promising early data. The Company has two licensing programs in which it has licensed exclusive 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 and include: the Company’s ability to develop new immunotherapeutic treatments for non-oncology or oncology indications; timing of initiation of studies for age-related diseases; the Company’s ability to continue as a going concern and that after considering the elements of the Company’s financing plan that were probable to occur within a year of the date of issuance, the Company concluded that substantial doubt was not alleviated in its going concern analysis; the Company’s cash runway; the Company’s expectations regarding future purchases of licensed molecules by Wugen; the Company’s ability to license its preclinical molecules; the initiation of patient enrollment for a clinical trial to evaluate HCW9302; whether the Company’s second-generation, pembrolizumab-based immunotherapeutics is effective against solid tumors, particularly for pancreatic and ovarian cancer; whether the Company’s two lead T-cell engagers target tissue factor and mesothelin are effective in reducing immunosuppression in tumor microenvironment; the Company’s future capital-raising including business development plans and ability to continue with clinical development efforts until they are achieved, if at all; and Company’s ability to pay legal fees incurred in connection with the arbitration with ImmunityBio and its affiliates. 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. 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 28, 2025 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. [email protected]
Investor releaseQuarter not tagged2025-08-16HCW Biologics Second Quarter 2025 Earnings: US$0.90 loss per share (vs US$16.16 loss in 2Q 2024)
Simply Wall St.
HCW Biologics Second Quarter 2025 Earnings: US$0.90 loss per share (vs US$16.16 loss in 2Q 2024)
Explore HCW Biologics's Fair Values from the Community and select yours Net loss: US$1.93m (loss narrowed by 87% from 2Q 2024). US$0.90 loss per share (improved from US$16.16 loss in 2Q 2024). AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. All figures shown in the chart above are for the trailing 12 month (TTM) period Looking ahead, revenue is expected to decline by 64% p.a. on average during the next 3 years, while revenues in the Biotechs industry in the US are expected to grow by 20%. Performance of the American Biotechs industry. The company's shares are down 11% from a week ago. Before you take the next step you should know about the 7 warning signs for HCW Biologics (6 don't sit too well with us!) that we have uncovered. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Investor releaseQuarter not tagged2025-05-16HCW Biologics Reports First Quarter 2025 Business Highlights and Financial Results
GlobeNewswire
HCW Biologics Reports First Quarter 2025 Business Highlights and Financial Results
MIRAMAR, Fla., May 15, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between inflammation and age-related diseases, today reported financial results and recent business highlights for its first quarter ended March 31, 2025. On May 15, 2025, the Company closed an equity offering with gross proceeds of $5.0 million with a single institutional investor. Dr. Hing Wong, Founder and CEO, stated, “We are pleased to have completed a successful $5.0 million equity offering in a difficult market without using a highly structured deal. This funding will be used to open clinical sites for our Phase 1 clinical trial to evaluate HCW9302 in an autoimmune disorder.” Dr. Wong continued, “Our new round of financing will provide funding for critical studies to complete the research package for our business development campaign to identify a licensing partner to commercialize our Immune-Cell Engagers, including T-Cell Engagers, which we created using our TRBC drug discovery and development platform.” Dr. Wong explained the Company’s financing strategy, stating, “We have over 50 compounds that we have created and own. We are continually assessing our portfolio of molecules to identify strong candidates to develop and commercialize through licensing or other business development transactions. We plan to ramp up our business development efforts in the second half of 2025. One of our compounds that is ready to commercialize is HCW9206, a clinical-stage molecule. It is a promising revolutionary reagent to replace anti-CD3/anti-CD28/IL-2-based approaches to streamline and lower the costs of CAR-T manufacturing. Equally important, we believe that HCW9206 can improve the functional activities and persistence of CAR-Ts following adoptive transfer, a goal that has not been achieved for the last decade.” Business Highlights Business Development Transactions On May 13, 2025, the Company delivered its technology report to WY Biotech in accordance with the terms of the WY Biotech exclusive worldwide licensing agreement to use and apply HCW11-006 for in vivo applications. HCW11-006 is a preclinical drug built with our second-generation discovery and development platform -- the TRBC platform. WY Bi…Read full documentShow less
MIRAMAR, Fla., May 15, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between inflammation and age-related diseases, today reported financial results and recent business highlights for its first quarter ended March 31, 2025. On May 15, 2025, the Company closed an equity offering with gross proceeds of $5.0 million with a single institutional investor. Dr. Hing Wong, Founder and CEO, stated, “We are pleased to have completed a successful $5.0 million equity offering in a difficult market without using a highly structured deal. This funding will be used to open clinical sites for our Phase 1 clinical trial to evaluate HCW9302 in an autoimmune disorder.” Dr. Wong continued, “Our new round of financing will provide funding for critical studies to complete the research package for our business development campaign to identify a licensing partner to commercialize our Immune-Cell Engagers, including T-Cell Engagers, which we created using our TRBC drug discovery and development platform.” Dr. Wong explained the Company’s financing strategy, stating, “We have over 50 compounds that we have created and own. We are continually assessing our portfolio of molecules to identify strong candidates to develop and commercialize through licensing or other business development transactions. We plan to ramp up our business development efforts in the second half of 2025. One of our compounds that is ready to commercialize is HCW9206, a clinical-stage molecule. It is a promising revolutionary reagent to replace anti-CD3/anti-CD28/IL-2-based approaches to streamline and lower the costs of CAR-T manufacturing. Equally important, we believe that HCW9206 can improve the functional activities and persistence of CAR-Ts following adoptive transfer, a goal that has not been achieved for the last decade.” Business Highlights Business Development Transactions On May 13, 2025, the Company delivered its technology report to WY Biotech in accordance with the terms of the WY Biotech exclusive worldwide licensing agreement to use and apply HCW11-006 for in vivo applications. HCW11-006 is a preclinical drug built with our second-generation discovery and development platform -- the TRBC platform. WY Biotech has 30-days due diligence to study this report, after which the Company expects to recognize revenue for a $7.0 million upfront licensing fee. On May 13, 2025, the Company delivered its technology report to WY Biotech in accordance with the terms of the WY Biotech exclusive worldwide licensing agreement to use and apply HCW11-006 for in vivo applications. HCW11-006 is a preclinical drug built with our second-generation discovery and development platform -- the TRBC platform. WY Biotech has 30-days due diligence to study this report, after which the Company expects to recognize revenue for a $7.0 million upfront licensing fee. Financing Transactions On May 15, 2025, the Company completed a $5.0 million offering of an aggregate of 671,140 units at a purchase price of $7.45 per unit priced at-the-market under Nasdaq rules. Each unit consisted of one share of Common Stock or one Pre-Funded Warrants to purchase one share of Common Stock, with two warrants, each of which can be exercised for one share of Common Stock for $7.45 per share. In addition, the Company entered into a privately negotiated agreement with the holder of certain existing outstanding warrants to purchase up to 167,925 shares of common stock (the “Existing Warrants”) to reduce the exercise price of such Existing Warrants from $41.20 per share to $7.45 per share. On May 15, 2025, the Company completed a $5.0 million offering of an aggregate of 671,140 units at a purchase price of $7.45 per unit priced at-the-market under Nasdaq rules. Each unit consisted of one share of Common Stock or one Pre-Funded Warrants to purchase one share of Common Stock, with two warrants, each of which can be exercised for one share of Common Stock for $7.45 per share. In addition, the Company entered into a privately negotiated agreement with the holder of certain existing outstanding warrants to purchase up to 167,925 shares of common stock (the “Existing Warrants”) to reduce the exercise price of such Existing Warrants from $41.20 per share to $7.45 per share. On May 13, 2025, the Company received a compliance letter from the Nasdaq Panel to confirm that the Company has regained compliance with the bid price requirement in Listing Rule 5550(a)(2), the public float requirement in Listing Rule 5550(a)(4), and the market value of publicly held shares requirement in Listing Rule 5550(a)(5), as required by the Nasdaq Panel decision of April 8, 2025, as amended. The Company remains subject to the remaining terms of the Panel’s April 8, 2025, decision to provide an extension to the compliance period for other Listing Rules. The Company must be in compliance with all Listing Rules by June 16, 2025. On May 13, 2025, the Company received a compliance letter from the Nasdaq Panel to confirm that the Company has regained compliance with the bid price requirement in Listing Rule 5550(a)(2), the public float requirement in Listing Rule 5550(a)(4), and the market value of publicly held shares requirement in Listing Rule 5550(a)(5), as required by the Nasdaq Panel decision of April 8, 2025, as amended. The Company remains subject to the remaining terms of the Panel’s April 8, 2025, decision to provide an extension to the compliance period for other Listing Rules. The Company must be in compliance with all Listing Rules by June 16, 2025. Clinical Development Results On January 28, 2025, the Company received clearance of its IND from the FDA to initiate a first-in-human Phase 1 dose escalation clinical trial to evaluate one of its lead drug candidates, HCW9302, in patients with moderate-to-severe alopecia areata, a common autoimmune disease in humans that currently has no curative FDA approved treatments. This will be a multi-site, Company-sponsored trial that is expected to be initiated in the third quarter of 2025. On January 28, 2025, the Company received clearance of its IND from the FDA to initiate a first-in-human Phase 1 dose escalation clinical trial to evaluate one of its lead drug candidates, HCW9302, in patients with moderate-to-severe alopecia areata, a common autoimmune disease in humans that currently has no curative FDA approved treatments. This will be a multi-site, Company-sponsored trial that is expected to be initiated in the third quarter of 2025. The Company is launching the commercialization of its clinical-stage molecule, HCW9206. Positive results of studies presented by the Company’s research collaborator Dr. Harris Goldstein’s laboratory at the Albert Einstein College of Medicine, Bronx, New York, at the 2025 Annual Meeting of American Association of Immunologists (AAI 2025), Honolulu, HI. The results of these studies represent an alternative novel strategy for CAR-T cell production with the advantage of generating a large population of CAR-Ts with a stem cell-like memory T cell phenotype, which should enhance the persistence of CAR-Ts in patients. We believe that this strategy will likely improve long-term survival of disease-specific CAR-Ts following adoptive transfer and enable sustained suppression of malignancies, chronic infections and autoimmune diseases, and lower the cost of CAR-T manufacturing. Also, we believe that it provides the Company with an in-road opportunity to participate in the development of “in-vivo CAR-T manufacturing technology,” a highly promising emergent field. The Company is launching the commercialization of its clinical-stage molecule, HCW9206. Positive results of studies presented by the Company’s research collaborator Dr. Harris Goldstein’s laboratory at the Albert Einstein College of Medicine, Bronx, New York, at the 2025 Annual Meeting of American Association of Immunologists (AAI 2025), Honolulu, HI. The results of these studies represent an alternative novel strategy for CAR-T cell production with the advantage of generating a large population of CAR-Ts with a stem cell-like memory T cell phenotype, which should enhance the persistence of CAR-Ts in patients. We believe that this strategy will likely improve long-term survival of disease-specific CAR-Ts following adoptive transfer and enable sustained suppression of malignancies, chronic infections and autoimmune diseases, and lower the cost of CAR-T manufacturing. Also, we believe that it provides the Company with an in-road opportunity to participate in the development of “in-vivo CAR-T manufacturing technology,” a highly promising emergent field. First Quarter 2025 Financial Results Revenues: Revenues for the first quarters ended March 31, 2024 and 2025 were $1.1 million and $5,065, respectively. Revenues in both periods were derived exclusively from the sale of licensed molecules to the Company’s licensee, Wugen. The licensed molecules are one of the components used by Wugen in manufacturing their immunotherapeutic products. Revenues: Revenues for the first quarters ended March 31, 2024 and 2025 were $1.1 million and $5,065, respectively. Revenues in both periods were derived exclusively from the sale of licensed molecules to the Company’s licensee, Wugen. The licensed molecules are one of the components used by Wugen in manufacturing their immunotherapeutic products. Research and development (R&D) expenses: R&D expenses for the first quarters ended March 31, 2024 and 2025 were $2.1 million and $1.5 million, respectively, a decrease of $644,573, or 30%. R&D expenses were comparatively lower in the reporting period of the first quarter of 2025 primarily due to a decline in manufacturing and material and preclinical expenses, but all expense categories were comparatively lower in the first quarter of 2025 when compared to the first quarter of 2024. Research and development (R&D) expenses: R&D expenses for the first quarters ended March 31, 2024 and 2025 were $2.1 million and $1.5 million, respectively, a decrease of $644,573, or 30%. R&D expenses were comparatively lower in the reporting period of the first quarter of 2025 primarily due to a decline in manufacturing and material and preclinical expenses, but all expense categories were comparatively lower in the first quarter of 2025 when compared to the first quarter of 2024. General and administrative (G&A) expenses: G&A expenses for the first quarters ended March 31, 2024 and 2025 were $1.6 million and $2.2 million, respectively, an increase of $661,505, or 42%. The increase was primarily due to the waiver of performance bonuses of $293,159 in the aggregate in the first quarter of 2024, which were earned by officers of the Company in prior periods. Expenses increased by $273,059 as a result of accretion of a fixed bonus that will be due if the Secured Notes are repaid on the Maturity Date. Subsequent to the end of the first quarter of 2025, $6.6 million of the outstanding principal for these Secured Notes elected to convert to equity and a portion of the Company’s shares in Wugen common stock. Other increases in expenses were related to insurance costs and professional services, such as auditing services as well as tax and accounting advisors. General and administrative (G&A) expenses: G&A expenses for the first quarters ended March 31, 2024 and 2025 were $1.6 million and $2.2 million, respectively, an increase of $661,505, or 42%. The increase was primarily due to the waiver of performance bonuses of $293,159 in the aggregate in the first quarter of 2024, which were earned by officers of the Company in prior periods. Expenses increased by $273,059 as a result of accretion of a fixed bonus that will be due if the Secured Notes are repaid on the Maturity Date. Subsequent to the end of the first quarter of 2025, $6.6 million of the outstanding principal for these Secured Notes elected to convert to equity and a portion of the Company’s shares in Wugen common stock. Other increases in expenses were related to insurance costs and professional services, such as auditing services as well as tax and accounting advisors. Legal expenses: Legal expenses, net represent the legal fees that the Company incurred for an Arbitration. On July 13, 2024, the parties entered into a Settlement Agreement and General Release, and the Arbitration and related Complaint were dismissed on December 24, 2024. In the first quarter of 2024, while the Company was preparing for the hearings which took place in May 2024, the Company incurred $4.4 million of legal fees. In January 2025, the Company received a $2.0 million insurance reimbursement that was paid directly to the law firm involved in representing Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, in the Arbitration. The Company is engaged in discussions with the law firms involved with this matter to arrange a reasonable payment plan with respect to those legal fees. Legal expenses: Legal expenses, net represent the legal fees that the Company incurred for an Arbitration. On July 13, 2024, the parties entered into a Settlement Agreement and General Release, and the Arbitration and related Complaint were dismissed on December 24, 2024. In the first quarter of 2024, while the Company was preparing for the hearings which took place in May 2024, the Company incurred $4.4 million of legal fees. In January 2025, the Company received a $2.0 million insurance reimbursement that was paid directly to the law firm involved in representing Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, in the Arbitration. The Company is engaged in discussions with the law firms involved with this matter to arrange a reasonable payment plan with respect to those legal fees. Net loss: Net loss for the first quarters ended March 31, 2024 and 2025 was $7.5 million and $2.2 million, respectively. Net loss: Net loss for the first quarters ended March 31, 2024 and 2025 was $7.5 million and $2.2 million, respectively. Financial Guidance As of March 31, 2025, 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 that were probable and likely to be implemented within the next year to determine if financing activities currently underway are sufficient to mitigate the substantial doubt in our going concern analysis. We have had some 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 all of the elements of our plan. About HCW Biologics HCW Biologics Inc. (NASDAQ: HCWB) is a clinical-stage biopharmaceutical company developing proprietary immunotherapies to treat diseases promoted by chronic inflammation, especially age-related and senescence-associated diseases. The Company’s immunotherapeutics represent a new class of drug that it believes have the potential to fundamentally change the treatment of cancer and many other diseases and conditions that are promoted by chronic inflammation — and in doing so, improve patients’ quality of life and possibly extend longevity. Chronic inflammation, including inflammaging, is believed to be a significant contributing factor to the cause for senescence-associated diseases and conditions that diminish healthspan, including many types of cancer, autoimmune diseases, and neurodegenerative diseases, as well as indications that impact quality-of-life that are not life-threatening. The Company’s lead product candidate, HCW9302, was developed using the Company’s legacy TOBI™ (Tissue factOr-Based fusIon) platform. The Company has created another drug discovery technology, the TRBC platform, which is not based on Tissue Factor. The TRBC platform has the capability to construct immunotherapeutics that not only activate and target immune responses but are also equipped with receptors that specifically target cancerous or infected cells. This platform is such a versatile scaffold that it enables the creation of multiple classes of immunotherapeutic compounds: Class I: Multi-Functional Immune Cell Stimulators; Class II: Second-Generation Immune Checkpoint Inhibitors; Class III: Multi-Specific Targeting Fusions and Enhanced Immune Cell Engagers. These novel immunotherapeutics can be used to treat a wide range of disease indications, including oncology, autoimmune diseases, and improving quality of life conditions. The Company has constructed over 50 molecules using the TRBC platform, including HCW11-002, HCW11-018 and HCW11-027. Further preclinical evaluation studies are currently being conducted for these three molecules the Company has selected based on promising early data. The Company has two licensing programs in which it has licensed exclusive 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 and include: the Company’s ability to develop new immunotherapeutic treatments for non-oncology or oncology indications; timing of initiation of studies for age-related diseases; the Company’s ability to continue as a going concern and that after considering the elements of the Company’s financing plan that were probable to occur within a year of the date of issuance, the Company concluded that substantial doubt was not alleviated in its going concern analysis; the Company’s cash runway; the Company’s expectations regarding future purchases of licensed molecules by Wugen; the Company’s ability to license its preclinical molecules; the initiation of patient enrollment for a clinical trial to evaluate HCW9302; the Company’s future capital-raising plans and ability to continue with clinical development efforts until they are achieved, if at all; and Company’s ability to pay legal fees incurred in connection with the arbitration with ImmunityBio and its affiliates. 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. 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 28, 2025 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. [email protected] HCW Biologics Inc. Unaudited Statements of Operations For the Three Months Ended March 31, 2024 2025 Revenues: Revenues $ 1,126,712 $ 5,065 Cost of revenues (511,965 ) (4,052 ) Net revenues 614,747 1,013 Operating expenses: Research and development 2,123,284 1,478,711 General and administrative 1,566,092 2,227,597 Legal expenses, net 4,419,034 (1,739,493 ) Total operating expenses 8,108,410 1,966,815 Loss from operations (7,493,663 ) (1,965,802 ) Interest expense — (255,822 ) Other income, net 25,602 24,749 Net loss $ (7,468,061 ) $ (2,196,875 ) Net loss per share, basic and diluted $ (0.20 ) $ (0.05 ) Weighted average shares outstanding, basic and diluted 37,223,588 44,675,656 HCW Biologics Inc. Condensed Balance Sheets December 31, March 31, 2024 2025 Unaudited ASSETS Current assets: Cash and cash equivalents $ 4,674,572 $ 1,107,613 Accounts receivable, net 582,201 87,493 Prepaid expenses 328,181 256,291 Other current assets 113,528 443,311 Total current assets 5,698,482 1,894,708 Investments 1,599,751 1,599,751 Property, plant and equipment, net 22,909,869 22,762,471 Other assets 28,476 28,476 Total assets $ 30,236,578 $ 26,285,406 LIABILITIES AND STOCKHOLDERS’ DEFICIT Liabilities Current liabilities: Accounts payable $ 22,332,261 $ 19,734,057 Accrued liabilities and other current liabilities 981,940 1,173,695 Short-term debt, net 6,314,684 6,234,338 Total current liabilities 29,628,885 27,142,090 Debt, net 7,377,865 7,705,364 Total liabilities 37,006,750 34,847,454 Commitments and contingencies Stockholders’ deficit: Common stock: Common, $0.0001 par value; 250,000,000 shares authorized and 44,541,295 shares issued at December 31, 2024; 250,000,000 shares authorized and 44,934,120 shares issued at March 31, 2025 4,454 4,493 Additional paid-in capital 93,781,511 94,186,471 Accumulated deficit (100,556,137 ) (102,753,012 ) Total stockholders’ deficit (6,770,172 ) (8,562,048 ) Total liabilities and stockholders’ deficit $ 30,236,578 $ 26,285,406
Investor releaseQuarter not tagged2025-05-13HCW Biologics Announces Positive Results of Studies of Proprietary Compound, HCW9206 and Availability for Commercialization
GlobeNewswire
HCW Biologics Announces Positive Results of Studies of Proprietary Compound, HCW9206 and Availability for Commercialization
Addresses key challenges for CAR-T therapies Potential to significantly reduce costs and improve clinical efficacy of engineered effector T cells Data Shared at 2025 Annual Meeting of American Association of Immunologists MIRAMAR, Fla., May 13, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (“HCWB” or the “Company”) (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies to extend healthspan by targeting the link between chronic inflammation and disease, announced today presentation of studies showing that its proprietary fusion protein, HCW9206, provides a new pathway for generating chimeric T-cell receptor - T cells (CAR-Ts) for immunotherapy with increased function. HCW9206 is a novel class of immunotherapeutic that enables a single molecule to deliver synergistic signals from three different immune-stimulatory cytokines. The activity of HCW9206 was significantly superior compared to standard methods employing anti-CD3/anti-CD28 and IL-2 reagents for CAR lentiviral transduction and subsequent expansion and persistence of human CAR-Ts. CAR-Ts represent a revolutionary technology with several CD19-specific CAR-T therapies approved by the FDA for the treatment of B-cell malignancies, and CAR-Ts continue to play an increasingly pivotal and expanding role in the treatment of cancer and has significant potential to treat autoimmune diseases and age-related diseases. The Company’s research collaborator Dr. Harris Goldstein’s laboratory at the Albert Einstein College of Medicine, Bronx, New York, recently presented findings of these studies at the 2025 Annual Meeting of American Association of Immunologists (AAI 2025), Honolulu, HI. The poster presentation reported that HCW9206 is not only a better reagent than the current anti-CD3/anti-CD28/IL-2 method for CAR-T viral transduction, it also effectively expanded stem cell-like memory T cells (Tscm) carrying the CAR constructs. It is well established that the Tscm subset of T cells exhibits more in vivo persistence and targeted cell killing than other subsets of T cells, including memory T cells, following adoptive transfer into patients. In experimental humanized models in mice, adoptively transferred HCW9206-generated HIV- and CD19-specific CAR-Ts displayed more potency in suppressing HIV-1 and leukemic cells with enhanced persistence, re…Read full documentShow less
Addresses key challenges for CAR-T therapies Potential to significantly reduce costs and improve clinical efficacy of engineered effector T cells Data Shared at 2025 Annual Meeting of American Association of Immunologists MIRAMAR, Fla., May 13, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (“HCWB” or the “Company”) (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies to extend healthspan by targeting the link between chronic inflammation and disease, announced today presentation of studies showing that its proprietary fusion protein, HCW9206, provides a new pathway for generating chimeric T-cell receptor - T cells (CAR-Ts) for immunotherapy with increased function. HCW9206 is a novel class of immunotherapeutic that enables a single molecule to deliver synergistic signals from three different immune-stimulatory cytokines. The activity of HCW9206 was significantly superior compared to standard methods employing anti-CD3/anti-CD28 and IL-2 reagents for CAR lentiviral transduction and subsequent expansion and persistence of human CAR-Ts. CAR-Ts represent a revolutionary technology with several CD19-specific CAR-T therapies approved by the FDA for the treatment of B-cell malignancies, and CAR-Ts continue to play an increasingly pivotal and expanding role in the treatment of cancer and has significant potential to treat autoimmune diseases and age-related diseases. The Company’s research collaborator Dr. Harris Goldstein’s laboratory at the Albert Einstein College of Medicine, Bronx, New York, recently presented findings of these studies at the 2025 Annual Meeting of American Association of Immunologists (AAI 2025), Honolulu, HI. The poster presentation reported that HCW9206 is not only a better reagent than the current anti-CD3/anti-CD28/IL-2 method for CAR-T viral transduction, it also effectively expanded stem cell-like memory T cells (Tscm) carrying the CAR constructs. It is well established that the Tscm subset of T cells exhibits more in vivo persistence and targeted cell killing than other subsets of T cells, including memory T cells, following adoptive transfer into patients. In experimental humanized models in mice, adoptively transferred HCW9206-generated HIV- and CD19-specific CAR-Ts displayed more potency in suppressing HIV-1 and leukemic cells with enhanced persistence, respectively, when compared with the same CD-19-specific CAR-Ts generated with standard methods. The results of these studies represent an alternative novel strategy for CAR-T cell production with the advantage of generating a large population of CAR-Ts with a Tscm cell phenotype, which should enhance the persistence of CAR-Ts in patients. This strategy will likely improve long-term survival of disease-specific CAR-Ts following adoptive transfer and enable sustained suppression of malignancies, chronic infections and autoimmune diseases. Dr. Hing C. Wong, the Founder and CEO of the Company, commented, “HCW9206 is a promising revolutionary reagent to replace anti-CD3/anti-CD28/IL-2-based approaches to streamline and lower the costs of CAR-T manufacturing. Equally important, HCW9206 can improve the functional activities and persistence of CAR-Ts following adoptive transfer, a goal that has not been achieved for the last decade. Also, it provides us with an in-road opportunity to participate in the development of the highly promising, emergent “in-vivo CAR-T manufacturing technology”. The GMP master cell bank of HCW9206 and its manufacturing process has been established, and its drug master file as an ex vivo reagent has also been filed with the US Food and Drug Administration. The Company is now seeking commercial partnerships for HCW9206 reagent sale and/or integration into CAR-T based manufacturing processes. You could find more about the presentation on HCW9206 at AAI 2025, entitled, “Generation of HIV- and CD19-Specific TSCM CAR-T Cells by a Novel Cytokine-Based Scaffold,” using the link below: AAI2025 About HCW Biologics: HCW Biologics Inc. (NASDAQ: HCWB) is a clinical-stage biopharmaceutical company developing proprietary immunotherapies to treat diseases promoted by chronic inflammation, especially age-related and senescence-associated diseases. The Company’s immunotherapeutics represent a new class of drug that it believes have the potential to fundamentally change the treatment of cancer and many other diseases and conditions that are promoted by chronic inflammation — and in doing so, improve patients’ quality of life and possibly extend longevity. Chronic inflammation, including inflammaging, is believed to be a significant contributing factor to the cause for senescence-associated diseases and conditions that diminish healthspan, including many types of cancer, autoimmune diseases, and neurodegenerative diseases, as well as indications that impact quality-of-life that are not life-threatening. The Company’s lead product candidate, HCW9302, was developed using the Company’s legacy TOBI™ (Tissue factOr-Based fusIon) platform. The Company has created another drug discovery technology, the TRBC platform, which is not based on Tissue Factor. The TRBC platform has the capability to construct immunotherapeutics that not only activate and target immune responses but are also equipped with receptors that specifically target cancerous or infected cells. This platform is such a versatile scaffold that it enables the creation of multiple classes of immunotherapeutic compounds: Class I: Multi-Functional Immune Cell Stimulators; Class II: Second-Generation Immune Checkpoint Inhibitors; Class III: Multi-Specific Targeting Fusions and Enhanced Immune Cell Engagers. These novel immunotherapeutics can be used to treat a wide range of disease indications, including oncology, autoimmune diseases, and improving quality of life conditions. The Company has constructed over 50 molecules using the TRBC platform, including HCW11-002, HCW11-018 and HCW11-027. Further preclinical evaluation studies are currently being conducted for these three molecules the Company has selected based on promising early data. The Company has two licensing programs in which it has licensed exclusive 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 and include, the efficacy of HCW9206 for generating CAR-T’s for immune cell therapy; and the ability of HCW9206 preclinical studies to translate into human trials to activate Tscm cells in patients; the ability of HCW9206 to improve long-term survival of disease-specific CAR-Ts following adoptive transfer and enable sustained suppression of malignancies, chronic infections and autoimmune diseases. 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. 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 28, 2025 and in other filings filed from time to time with the SEC. Company Contact: Peter Rhode, PhD. Chief Scientific Officer and Vice President Clinical Operations HCW Biologics Inc. [email protected]
Investor releaseQuarter not tagged2025-03-29HCW Biologics Reports Fourth Quarter and Fiscal Year 2024 Business Highlights and Financial Results
GlobeNewswire
HCW Biologics Reports Fourth Quarter and Fiscal Year 2024 Business Highlights and Financial Results
MIRAMAR, Fla., March 28, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between inflammation and age-related diseases, today reported financial results and recent business highlights for its fourth quarter and fiscal year ended December 31, 2024. Dr. Hing Wong, Founder and CEO, stated, “We are more passionate than ever about our desire to create breakthrough immunotherapeutic treatments for diseases with no known cures, especially pancreatic, ovarian cancer and other age-related diseases. We have received clearance to begin clinical trials in alopecia areata, our first-quality-of-life indication, with one of our lead molecules, HCW9302. In non-human primate studies, HCW9302 is well tolerated at the dose level of effectively expanding regulatory T (“Treg”) cells. Our surrogate efficacious marker for HCW9302 in treated patients is the expansion of Treg cells after subcutaneous administration.” Further, Dr. Wong provided insights to the Company’s preclinical programs, adding, “Our preclinical programs are also promising. In the fourth quarter of 2024, the Company revealed its new drug discovery and development platform, with a novel scaffolding or “backbone” of proteins called T-cell Receptor β Chain constant region (“TRBC”). The TRBC drug discovery and development platform leverages the Company’s in-depth knowledge of T cell and natural killer (“NK”) cell immunology. The Company has constructed 50 proprietary compounds with the TRBC platform for the treatment of hematologic and solid tumors, virally infected cells, and cellular senescence diseases associated with aging.” Dr. Wong explained, “Our expanded portfolio now includes constructs with immune-cell engagers targeting cell-surface antigens associated with diseased cells and multifunctional immunotherapeutic fusions which improve the performance of immune checkpoint inhibitors. They exhibit remarkably target-specific anti-tumor activity and tolerability in relevant animal models.” He continued, “We believe that some of our TRBC-based molecules could be a game-changer for Cell and Gene Based Therapies (“CGTs”) by significantly reducing cost and improving the clinical efficacy of engineered effector cells for CGT.…Read full documentShow less
MIRAMAR, Fla., March 28, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between inflammation and age-related diseases, today reported financial results and recent business highlights for its fourth quarter and fiscal year ended December 31, 2024. Dr. Hing Wong, Founder and CEO, stated, “We are more passionate than ever about our desire to create breakthrough immunotherapeutic treatments for diseases with no known cures, especially pancreatic, ovarian cancer and other age-related diseases. We have received clearance to begin clinical trials in alopecia areata, our first-quality-of-life indication, with one of our lead molecules, HCW9302. In non-human primate studies, HCW9302 is well tolerated at the dose level of effectively expanding regulatory T (“Treg”) cells. Our surrogate efficacious marker for HCW9302 in treated patients is the expansion of Treg cells after subcutaneous administration.” Further, Dr. Wong provided insights to the Company’s preclinical programs, adding, “Our preclinical programs are also promising. In the fourth quarter of 2024, the Company revealed its new drug discovery and development platform, with a novel scaffolding or “backbone” of proteins called T-cell Receptor β Chain constant region (“TRBC”). The TRBC drug discovery and development platform leverages the Company’s in-depth knowledge of T cell and natural killer (“NK”) cell immunology. The Company has constructed 50 proprietary compounds with the TRBC platform for the treatment of hematologic and solid tumors, virally infected cells, and cellular senescence diseases associated with aging.” Dr. Wong explained, “Our expanded portfolio now includes constructs with immune-cell engagers targeting cell-surface antigens associated with diseased cells and multifunctional immunotherapeutic fusions which improve the performance of immune checkpoint inhibitors. They exhibit remarkably target-specific anti-tumor activity and tolerability in relevant animal models.” He continued, “We believe that some of our TRBC-based molecules could be a game-changer for Cell and Gene Based Therapies (“CGTs”) by significantly reducing cost and improving the clinical efficacy of engineered effector cells for CGT. Based on preclinical studies, it appears they also support the rapidly developing “in-vivo” CAR-T manufacturing approach for CGT. We are excited to share the data in future scientific publications and invited presentations. We believe that we are uniquely positioned for a strong clinical development pipeline through our own programs and with corporate partnerships.” Business Highlights Business Development Transactions The Company’s clinical development strategy is to select certain proprietary molecules for development through out-licensing arrangements and other business development transactions. The Company continually assesses its portfolio of molecules in order to identify potential business development opportunities. The Company’s clinical development strategy is to select certain proprietary molecules for development through out-licensing arrangements and other business development transactions. The Company continually assesses its portfolio of molecules in order to identify potential business development opportunities. On November 17, 2024, the Company entered an exclusive worldwide licensing agreement with WY Biotech Co. Ltd. (“WY Biotech”), which was amended in 2025. Under the amended agreement, the Company expects to receive $7.0 million in June 2025. The WY Biotech license agreement grants WY Biotech the exclusive, world-wide license to use and apply HCW11-006 for in vivo applications. HCW11-006 is a preclinical drug. Under the terms of the license agreement, the Company has opt-in rights to reclaim the Americas market, including United States, Canada, Central America, and South America, at no cost which may be exercised after WY Biotech completes a Phase 1 clinical trial. On November 17, 2024, the Company entered an exclusive worldwide licensing agreement with WY Biotech Co. Ltd. (“WY Biotech”), which was amended in 2025. Under the amended agreement, the Company expects to receive $7.0 million in June 2025. The WY Biotech license agreement grants WY Biotech the exclusive, world-wide license to use and apply HCW11-006 for in vivo applications. HCW11-006 is a preclinical drug. Under the terms of the license agreement, the Company has opt-in rights to reclaim the Americas market, including United States, Canada, Central America, and South America, at no cost which may be exercised after WY Biotech completes a Phase 1 clinical trial. The next major business development program will focus on Immune-Cell Engagers, including T-Cell Engagers. In light of recent transactions demonstrating the strong interest in this class of therapeutics by larger pharmaceutical with the necessary clinical development expertise, the Company intends to develop these molecules through corporate partnering and out-licensing arrangements. The next major business development program will focus on Immune-Cell Engagers, including T-Cell Engagers. In light of recent transactions demonstrating the strong interest in this class of therapeutics by larger pharmaceutical with the necessary clinical development expertise, the Company intends to develop these molecules through corporate partnering and out-licensing arrangements. Financing Transactions In 2024, the Company raised $16.3 million: On February 20, 2024, it raised $2.5 million in a private placement of common stock with officers and directors. In multiple closings throughout 2024, it raised $6.9 million in Senior Notes, which are secured by the Company’s shares of Wugen common stock. The Company received shares of Wugen stock as an upfront licensing fee for the Wugen exclusive worldwide license for some of the Company’s proprietary molecules. On November 18, 2024, the Company entered a $6.9 million securities purchase agreement with an institutional investor, involving a registered direct offering and a concurrent private placement of common stock and warrants. In 2024, the Company raised $16.3 million: On February 20, 2024, it raised $2.5 million in a private placement of common stock with officers and directors. On February 20, 2024, it raised $2.5 million in a private placement of common stock with officers and directors. In multiple closings throughout 2024, it raised $6.9 million in Senior Notes, which are secured by the Company’s shares of Wugen common stock. The Company received shares of Wugen stock as an upfront licensing fee for the Wugen exclusive worldwide license for some of the Company’s proprietary molecules. In multiple closings throughout 2024, it raised $6.9 million in Senior Notes, which are secured by the Company’s shares of Wugen common stock. The Company received shares of Wugen stock as an upfront licensing fee for the Wugen exclusive worldwide license for some of the Company’s proprietary molecules. On November 18, 2024, the Company entered a $6.9 million securities purchase agreement with an institutional investor, involving a registered direct offering and a concurrent private placement of common stock and warrants. On November 18, 2024, the Company entered a $6.9 million securities purchase agreement with an institutional investor, involving a registered direct offering and a concurrent private placement of common stock and warrants. On February 20, 2025, the Company entered into an Equity Purchase Agreement with Square Gate Capital Master Fund, LLC - Series 4 (“Square Gate”), pursuant to which the Company will have the right, but not the obligation, to sell to Square Gate, and Square Gate will have the obligation to purchase from the Company, up to $20,000,000 (with a potential increase of an additional $20,000,000) worth of the Company’s shares of common stock, at the Company’s sole discretion, over the next 36 months, subject to certain conditions precedent and other limitations. On February 20, 2025, the Company entered into an Equity Purchase Agreement with Square Gate Capital Master Fund, LLC - Series 4 (“Square Gate”), pursuant to which the Company will have the right, but not the obligation, to sell to Square Gate, and Square Gate will have the obligation to purchase from the Company, up to $20,000,000 (with a potential increase of an additional $20,000,000) worth of the Company’s shares of common stock, at the Company’s sole discretion, over the next 36 months, subject to certain conditions precedent and other limitations. Compliance with Nasdaq Listing Rules During 2024, the Company received three deficiency notices from the Listing Staff of The Nasdaq Stock Market (the “Exchange”) related to the Company’s stock price of trading shares and the market value of the Company. On March 3, 2025, the Nasdaq Hearings Panel (the “Panel”) granted the Company an extension in which to regain compliance with all Nasdaq continued listing rules. As a result of the extension, the Panel granted the Company’s request for continued listing on the Exchange, provided that the Company demonstrates compliance with the Bid Price Rule by April 28, 2025, and all other Exchange continued listing rules by June 15, 2025. During 2024, the Company received three deficiency notices from the Listing Staff of The Nasdaq Stock Market (the “Exchange”) related to the Company’s stock price of trading shares and the market value of the Company. On March 3, 2025, the Nasdaq Hearings Panel (the “Panel”) granted the Company an extension in which to regain compliance with all Nasdaq continued listing rules. As a result of the extension, the Panel granted the Company’s request for continued listing on the Exchange, provided that the Company demonstrates compliance with the Bid Price Rule by April 28, 2025, and all other Exchange continued listing rules by June 15, 2025. On March 31, 2025, the Company will hold a Special Meeting of the Stockholders to obtain stockholder approval for three proposals critical for the success of the compliance plan presented to the Panel, including a reverse stock split, use of the full line of the Equity Line of Credit, and approval of the terms to convert the Senior Notes issued in 2024 into equity. On March 31, 2025, the Company will hold a Special Meeting of the Stockholders to obtain stockholder approval for three proposals critical for the success of the compliance plan presented to the Panel, including a reverse stock split, use of the full line of the Equity Line of Credit, and approval of the terms to convert the Senior Notes issued in 2024 into equity. Clinical Development Results On January 28, 2025, the Company received clearance of its IND from the FDA to initiate a first-in-human Phase 1 dose escalation clinical trial to evaluate one of its lead drug candidates, HCW9302, in patients with moderate-to-severe alopecia areata, a common autoimmune disease in humans that currently has no curative FDA approved treatments. On January 28, 2025, the Company received clearance of its IND from the FDA to initiate a first-in-human Phase 1 dose escalation clinical trial to evaluate one of its lead drug candidates, HCW9302, in patients with moderate-to-severe alopecia areata, a common autoimmune disease in humans that currently has no curative FDA approved treatments. As of December 31, 2024, the Company was required to close the Phase 2 clinical study to evaluate HCW9218 in combination with neoadjuvant chemotherapy in ovarian cancer sponsored by the University of Pittsburgh Medical Center, as required under the Settlement Agreement, due to lack of enrollment. As of December 31, 2024, the Company was required to close the Phase 2 clinical study to evaluate HCW9218 in combination with neoadjuvant chemotherapy in ovarian cancer sponsored by the University of Pittsburgh Medical Center, as required under the Settlement Agreement, due to lack of enrollment. Financial Results Revenues: Revenues for the fourth quarters ended December 31, 2023 and 2024 were $1.3 million and $394,000, respectively. Revenues for the years ended December 31, 2023 and 2024 were $2.8 million and $2.6 million, respectively. Revenues in both periods were derived exclusively from the sale of licensed molecules to the Company’s licensee, Wugen. The licensed molecules are one of the components used by Wugen in manufacturing their immunotherapeutic products. Revenues: Revenues for the fourth quarters ended December 31, 2023 and 2024 were $1.3 million and $394,000, respectively. Revenues for the years ended December 31, 2023 and 2024 were $2.8 million and $2.6 million, respectively. Revenues in both periods were derived exclusively from the sale of licensed molecules to the Company’s licensee, Wugen. The licensed molecules are one of the components used by Wugen in manufacturing their immunotherapeutic products. Research and development (R&D) expenses: R&D expenses for the fourth quarters ended December 31, 2023 and 2024 were $2.1 million and $1.0 million, respectively, a decrease of $1.1 million, or 51%. R&D expenses for the years ended December 31, 2023 and 2024 were $7.7 million and $6.4 million, respectively, a decrease of $1.3 million, or 17%. R&D expenses were comparatively higher in the reporting periods of 2023 because there were two ongoing clinical trials to evaluate HCW9218 in cancer indications, and IND-enabling studies required for the IND application for HCW9302, including toxicology studies. For the year ended December 31, 2024, the decrease in R&D expenses compared to the comparable period in 2023 was partially offset by an increase in manufacturing costs for replenishing supply of the high-expressing cell line of HCW9101. Research and development (R&D) expenses: R&D expenses for the fourth quarters ended December 31, 2023 and 2024 were $2.1 million and $1.0 million, respectively, a decrease of $1.1 million, or 51%. R&D expenses for the years ended December 31, 2023 and 2024 were $7.7 million and $6.4 million, respectively, a decrease of $1.3 million, or 17%. R&D expenses were comparatively higher in the reporting periods of 2023 because there were two ongoing clinical trials to evaluate HCW9218 in cancer indications, and IND-enabling studies required for the IND application for HCW9302, including toxicology studies. For the year ended December 31, 2024, the decrease in R&D expenses compared to the comparable period in 2023 was partially offset by an increase in manufacturing costs for replenishing supply of the high-expressing cell line of HCW9101. General and administrative (G&A) expenses: G&A expenses for the quarters ended December 31, 2023 and 2024 were $1.7 million and $2.0 million, respectively, an increase of $367,320, or 22%. G&A expenses for the years ended December 31, 2023 and 2024 were $6.8 million and $6.8 million, respectively, an increase of $60,081, or 1%. Changes in G&A expenses reflect cost cutting measures effected by the Company in the second quarter of 2024, offset by increases in professional fees, facilities and office expenses, and financing expenses. General and administrative (G&A) expenses: G&A expenses for the quarters ended December 31, 2023 and 2024 were $1.7 million and $2.0 million, respectively, an increase of $367,320, or 22%. G&A expenses for the years ended December 31, 2023 and 2024 were $6.8 million and $6.8 million, respectively, an increase of $60,081, or 1%. Changes in G&A expenses reflect cost cutting measures effected by the Company in the second quarter of 2024, offset by increases in professional fees, facilities and office expenses, and financing expenses. Legal expenses: Legal expenses for the quarter ended December 31, 2023 and 2024 were $2.0 million and $148,949, respectively, a decrease of $1.8 million, or 92%. Legal expenses for the twelve months ended December 31, 2023 and 2024 were $6.6 million and $15.9 million, respectively, an increase of $9.3 million, or 142%. The increase in legal expenses related to preparation of testimony and evidence for the hearing and the hearing itself in connection to the Arbitration with ImmunityBio and its affiliates. On July 13, 2024, the parties entered into a Settlement Agreement and General Release, and the Arbitration and related Complaint were dismissed on December 24, 2024. The Company is engaged in discussions with the law firms involved with this matter to arrange a reasonable payment plan with respect to those legal fees. Legal expenses: Legal expenses for the quarter ended December 31, 2023 and 2024 were $2.0 million and $148,949, respectively, a decrease of $1.8 million, or 92%. Legal expenses for the twelve months ended December 31, 2023 and 2024 were $6.6 million and $15.9 million, respectively, an increase of $9.3 million, or 142%. The increase in legal expenses related to preparation of testimony and evidence for the hearing and the hearing itself in connection to the Arbitration with ImmunityBio and its affiliates. On July 13, 2024, the parties entered into a Settlement Agreement and General Release, and the Arbitration and related Complaint were dismissed on December 24, 2024. The Company is engaged in discussions with the law firms involved with this matter to arrange a reasonable payment plan with respect to those legal fees. Reserve for credit losses and other expenses: In the year ended December 31, 2023, the Company recognized a reserve for credit losses related to a $5.3 million interest reserve deposit that was not refunded as required by the lender after the Company terminated their credit agreement. In the year ended December 31, 2024, the Company recognized a $1.3 million loss resulting from the misdirection of funds held in Company accounts to a fraudulent account controlled by a third party. Reserve for credit losses and other expenses: In the year ended December 31, 2023, the Company recognized a reserve for credit losses related to a $5.3 million interest reserve deposit that was not refunded as required by the lender after the Company terminated their credit agreement. In the year ended December 31, 2024, the Company recognized a $1.3 million loss resulting from the misdirection of funds held in Company accounts to a fraudulent account controlled by a third party. Net loss: Net loss for the fourth quarters ended December 31, 2023 and 2024 was $10.7 million and $3.4 million, respectively. Net loss for the years ended December 31, 2023 and 2024 was $25.0 million and $30.0 million, respectively, including legal fees incurred in connection with the Arbitration discussed above. Net loss: Net loss for the fourth quarters ended December 31, 2023 and 2024 was $10.7 million and $3.4 million, respectively. Net loss for the years ended December 31, 2023 and 2024 was $25.0 million and $30.0 million, respectively, including legal fees incurred in connection with the Arbitration discussed above. Financial Guidance As of December 31, 2024, 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 that were probable and likely to be implemented within the next year to determine if financing activities currently underway are sufficient to mitigate the substantial doubt in our going concern analysis. After launching a multi-step financing plan in the third quarter of 2024, we have completed financing transactions. We have additional capital-raising activities planned for the first half of 2025, for which Maxim Group LLC will act as our Placement Agent. If the Company is not successful in raising additional capital through these activities, management may need to revise its business plan and reduce costs. About HCW Biologics HCW Biologics is a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between chronic, low-grade inflammation, and age-related diseases, such as cancer, cardiovascular, diabetes, neurodegenerative, and autoimmune diseases, as well as other inflammatory conditions. The Company has combined a deep understanding of disease-related immunology with its expertise in advanced protein engineering to develop two drug discovery platforms, each with a novel backbone which is used to generate designer, novel multi-functional fusion molecules with immunotherapeutic properties. The Company’s legacy drug discovery platform is its TOBI™ (Tissue factOr-Based fusIon) discovery platform, which has a Tissue-Factor based backbone. It was used to create HCW Biologics’ molecules: HCW9218, HCW9302, HCW9206 and HCW9201. HCW9302 is a clinical-stage molecule, cleared by the FDA to be evaluated in patients with an autoimmune disorder. The Company’s second generation drug discovery and development platform, called the T-cell Receptor β Chain constant region (“TRBC”) platform, uses a unique protein-based backbone. Immunotherapeutics created with the Company’s two distinct drug discovery platforms have different characteristics and mechanisms of action, expanding the various pathways for treating senescence-associated disorders. 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 and include: the Company’s ability to develop new immunotherapeutic treatments for non-oncology or oncology indications; timing of initiation of studies for age-related diseases; the Company’s ability to continue as a going concern and that after considering the elements of the Company’s financing plan that were probable to occur within a year of the date of issuance, the Company concluded that substantial doubt was not alleviated in its going concern analysis; the Company’s cash runway; the Company’s expectations regarding future purchases of licensed molecules by Wugen; the Company’s ability to finalize the license of a preclinical molecule; the initiation of patient enrollment for clinical trial to evaluate HCW9302; the Company’s future capital-raising plans and ability to continue with clinical development efforts until they are achieved, if at all; and Company’s ability to pay legal fees incurred in connection with the arbitration with ImmunityBio and its affiliates. 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. 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 28, 2025 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. [email protected] HCW Biologics Inc. Statements of Operations For the Three Months Ended December 31, Years Ended December 31, 2023 2024 2023 2024 Revenues: Unaudited Audited Revenues $ 1,324,003 $ 394,804 $ 2,841,794 $ 2,566,792 Cost of revenues (1,071,357 ) (315,843 ) (2,281,434 ) (1,607,389 ) Net revenues 252,646 78,961 560,360 959,403 Operating expenses: Research and development 2,136,397 1,049,611 7,676,316 6,388,994 General and administrative 1,672,840 2,040,160 6,779,515 6,839,596 Legal expenses 1,961,599 148,949 6,571,689 15,910,480 Reserve for credit losses and other expenses 5,250,000 — 5,250,000 1,300,000 Total operating expenses 11,020,836 3,238,720 26,277,520 30,439,070 Loss from operations (10,768,190 ) (3,159,759 ) (25,717,160 ) (29,479,667 ) Interest expense — (248,107 ) (283,042 ) (631,137 ) Other income, net 87,660 34,593 1,005,925 86,990 Net loss $ (10,680,530 ) $ (3,373,273 ) $ (24,994,277 ) $ (30,023,814 ) Net loss per share, basic and diluted $ (0.30 ) $ (0.08 ) $ (0.70 ) $ (0.77 ) Weighted average shares outstanding, basic and diluted 35,996,415 42,301,694 35,929,446 38,793,018 HCW Biologics Inc. Audited Balance Sheets December 31, December 31, 2023 2024 ASSETS Current assets: Cash and cash equivalents $ 3,595,101 $ 4,674,572 Accounts receivable, net 1,535,757 582,201 Prepaid expenses 1,042,413 328,181 Other current assets 230,916 113,528 Total current assets 6,404,187 5,698,482 Investments 1,599,751 1,599,751 Property, plant and equipment, net 20,453,184 22,909,869 Other assets 56,538 28,476 Total assets $ 28,513,660 $ 30,236,578 LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) Liabilities Current liabilities: Accounts payable $ 6,167,223 $ 22,332,261 Accrued liabilities and other current liabilities 2,580,402 981,940 Short-term debt, net — 6,314,684 Total current liabilities 8,747,625 29,628,885 Debt, net 6,304,318 7,377,865 Total liabilities 15,051,943 37,006,750 Commitments and contingencies Stockholders’ equity (deficit): Common stock: Common, $0.0001 par value; 250,000,000 shares authorized and 36,025,104 shares issued at December 31, 2023; 250,000,000 shares authorized and 44,541,295 shares issued at December 31, 2024 3,603 4,454 Additional paid-in capital 83,990,437 93,781,511 Accumulated deficit (70,532,323 ) (100,556,137 ) Total stockholders’ equity (deficit) 13,461,717 (6,770,172 ) Total liabilities and stockholders’ equity (deficit) $ 28,513,660 $ 30,236,578 ----

