Welcome to our dedicated page for Hcw Biologics news (Ticker: HCWB), a resource for investors and traders seeking the latest updates and insights on Hcw Biologics stock.
HCW Biologics Inc. (NASDAQ: HCWB) is a clinical-stage biopharmaceutical company developing proprietary immunotherapies to treat diseases driven by chronic inflammation, particularly age-related and senescence-associated conditions. News about HCW Biologics often centers on its fusion protein platforms, clinical trial milestones, licensing deals, and capital markets activity.
A key focus of recent announcements is the company’s lead product candidate, HCW9302, an IL-2-based fusion molecule developed using its TOBI platform. HCW Biologics has reported dosing the first patient in a company-sponsored, multi-center Phase 1, first-in-human clinical trial in patients with alopecia areata, an autoimmune disease with no curative FDA-approved treatments. Updates on this trial include site openings, patient screening, and the study’s design to evaluate safety, determine a recommended dose, and assess effects on regulatory T cells and disease responses.
Investors following HCWB news also see regular coverage of the company’s TRBC-based programs, including preclinical and IND-enabling data for HCW11-040, a second-generation pembrolizumab-based immune checkpoint inhibitor, and HCW11-018b, a tetra-valent T-cell engager targeting tissue factor in solid tumors. Presentations at scientific meetings such as the Society for Immunotherapy of Cancer (SITC) and Virtual Investor segments highlight mechanistic data, safety findings in non-human primates, and potential advantages over first-generation therapies.
On the corporate side, HCW Biologics issues news about licensing and co-development agreements, such as its amended and restated license with Beijing Trimmune Biotech Co., Ltd., as well as its minority equity interest and licensing relationship with Wugen, Inc. Financing updates, including warrant inducement transactions, equity issuances under a Standby Equity Purchase Agreement, and Nasdaq listing compliance developments, are also frequent topics. For investors and observers, the HCWB news stream provides insight into scientific progress, partnership activity, and the company’s efforts to fund and advance its pipeline.
HCW Biologics (NASDAQ: HCWB), a clinical-stage biopharmaceutical company, presented its second-generation T-Cell Engager (TCE) program in a Virtual Investor segment. Chief Scientific Officer Dr. Peter Rhode discussed the company's recent advancements in their TCE technology.
The company's improved TCE program demonstrates enhanced manufacturability, safety profile, and effectiveness against solid tumors. These second-generation TCEs aim to address key limitations of first-generation treatments, including complex manufacturing, tolerability issues, and limited efficacy for solid tumors. HCW Biologics has positioned itself among select biotech companies developing innovative TCEs that can overcome resistance mechanisms.
HCW Biologics (NASDAQ: HCWB), a clinical-stage biopharmaceutical company, announced that Wugen, a company in which it holds a minority stake, has secured a $115 million equity financing led by Fidelity Management & Research Company. The financing included participation from several prominent life sciences investors.
HCW Biologics' stake in Wugen originated from a 2020 Exclusive License Agreement, which has generated $16.2 million in revenues for HCW through license fees (paid in cash and Wugen stock) and clinical material sales. The funding will support Wugen's development of allogeneic, off-the-shelf CAR-T cell therapies.
HCW Biologics (NASDAQ: HCWB) has selected HCW11-040, one of its proprietary pembrolizumab-based immune checkpoint inhibitors, as its lead product candidate for solid tumor treatment. The molecule combines pembrolizumab (Keytruda®) with IL-7, IL-15, and TGF-β receptor components.
In preclinical studies, HCW11-040 demonstrated superior performance compared to pembrolizumab monotherapy in several key areas: immune-cell activation, tumor infiltration, and cancer cell cytotoxicity. Notably, the compound showed the ability to expand TPEX cells without triggering cytokine storm when administered subcutaneously at projected efficacious doses.
The company will now advance HCW11-040 to late-phase IND-enabling studies, including manufacturing cell bank creation, chemistry manufacture control process development, and preclinical GLP toxicology studies.
HCW Biologics (NASDAQ: HCWB) has announced positive results from its non-human primate study for second-generation T-cell engagers (TCEs) targeting solid tumors. The company's lead drug candidate demonstrated strong safety profile and tolerance at doses significantly higher than efficacious levels.
The company's proprietary TRBC platform technology has developed TCEs targeting tissue factor and mesothelin, showing potent anti-pancreatic cancer activities in preclinical studies. Key advantages include reduced immunosuppression in tumor microenvironment, cost-effective manufacturing, and potential treatment for multiple solid tumors including pancreatic cancer and glioblastoma.
Notably, preclinical studies showed 100% survival rate in tumor-bearing mice treated with their TCE candidate. The company is now positioned to seek high-value corporate partnerships to advance development.
HCW Biologics (NASDAQ: HCWB) has developed a breakthrough second-generation pembrolizumab-based immune checkpoint inhibitor (ICI) using its proprietary TRBC platform technology. The company's novel immunotherapeutic has shown superior performance against solid tumors, particularly pancreatic and ovarian cancer, in preclinical studies.
The new therapy addresses key limitations of current ICIs, which have less than 20% response rates despite generating $40 billion in worldwide sales in 2024. HCWB's enhanced version not only blocks checkpoint receptors but also neutralizes TGF-β and promotes immune cell infiltration into tumors, demonstrating better efficacy than standard pembrolizumab in preclinical trials.
Dr. Hing C. Wong, CEO, will present detailed IND-enabling study results at Nova Southeastern University on September 12, 2025.
HCW Biologics (NASDAQ: HCWB) reported Q2 2025 financial results and business updates. The company completed a $5.0 million equity offering with an institutional investor and extinguished $7.7 million in debt. Key developments include WY Biotech's acceptance of their technical report with a $7.0 million license fee due by September 30, 2025, and a one-year suspension of the Wugen License Agreement to seek alternative licensing for HCW9206.
Financial results showed Q2 2025 revenues of $6,550, down from $618,854 in Q2 2024. R&D expenses decreased 40% to $1.2 million, while G&A expenses increased 31% to $2.1 million. Net loss improved to $1.9 million from $15.3 million in Q2 2024. The company regained compliance with Nasdaq listing requirements but noted substantial going concern doubts without additional funding.
[ "Successful completion of $5.0 million equity offering", "Extinguishment of $7.7 million in debt through restructuring or conversion", "Regained compliance with all Nasdaq listing requirements", "40% reduction in R&D expenses to $1.2 million", "Net loss improved significantly to $1.9 million from $15.3 million YoY", "Potential $7.0 million license fee from WY Biotech due by September 2025" ]HCW Biologics (NASDAQ: HCWB) announced successful development of second-generation, multi-specific T-cell engagers targeting solid tumors, particularly pancreatic cancer, using their proprietary TRBC platform technology. The company's lead T-cell engagers target tissue factor and mesothelin, demonstrating potent anti-pancreatic cancer activities in preclinical studies.
The breakthrough technology not only targets cancer antigens and activates T cells but also reduces immunosuppression in the tumor microenvironment. In preclinical studies, 100% survival was observed in tumor-bearing mice treated with TRBC-based T-cell engagers, while untreated mice did not survive. Dr. Hing C. Wong, Founder and CEO, will present these IND-enabling study results at the Phoenix Best Science Series on June 27, 2025.
HCW Biologics (NASDAQ: HCWB), a clinical-stage biopharmaceutical company, has successfully regained compliance with all Nasdaq Capital Market listing requirements. The company received confirmation from Nasdaq on June 24, 2025 that it met the minimum stockholders' equity requirement (Rule 5550(b)(1)).
Previously, on May 13, 2025, HCWB had already regained compliance with other crucial requirements including bid price (Rule 5550(a)(2)), public float (Rule 5550(a)(4)), and market value of publicly held shares (Rule 5550(a)(5)). The company, which focuses on developing innovative immunotherapies targeting chronic inflammation, is now fully compliant for continued listing on the Nasdaq Capital Market.
HCW Biologics (NASDAQ: HCWB) reported its Q1 2025 financial results and completed a $5.0 million equity offering with an institutional investor. The company's Q1 2025 revenues decreased to $5,065 from $1.1 million in Q1 2024, while net loss improved to $2.2 million from $7.5 million. R&D expenses decreased 30% to $1.5 million, while G&A expenses increased 42% to $2.2 million.
Key developments include FDA clearance for a Phase 1 trial of HCW9302 for alopecia areata, and an expected $7.0 million upfront licensing fee from WY Biotech for HCW11-006. The company regained Nasdaq compliance but must meet all listing requirements by June 16, 2025. Management expressed concerns about the company's ability to continue as a going concern without additional funding.