HCW Biologics Inc. develops fusion immunotherapeutics for diseases associated with chronic inflammation, including autoimmune disorders, proinflammatory diseases, cancer and senescence-associated dysplasia. Its recurring company updates center on the TOBI and TRBC discovery platforms and product candidates such as HCW9302, an IL-2 fusion immunotherapeutic, HCW11-018b, a T-cell engager for solid tumors, and HCW9206, a multi-cytokine fusion protein reagent used in CAR-T manufacturing research.
News about HCWB also covers clinical and preclinical program disclosures, research publications, licensing activity involving HCW11-006 and Trimmune, operating and financial results, capital-structure matters, shareholder voting topics and Nasdaq listing-status developments.
HCW Biologics (Nasdaq: HCWB) announced that on February 26, 2026 the Nasdaq Hearings Panel found the company regained compliance with all continued listing rules of the Nasdaq Capital Market.
This determination preserves HCWB's access to public capital markets to fund its clinical-stage immunotherapy programs, the company said.
HCW Biologics (NASDAQ: HCWB) priced a follow-on at-the-market offering of 2,477,292 units at $0.6055 per unit, raising approximately $1.5 million gross, with expected close on or about February 19, 2026.
The units include one share (or pre-funded warrant) and one warrant exercisable upon shareholder approval; the company also seeks shareholder approval to reduce exercise price on up to 3,020,410 existing warrants to $0.6055.
HCW Biologics (NASDAQ: HCWB) and WY Biotech formed joint venture Trimmune to develop HCW11-006 under an exclusive worldwide license, with Trimmune backed by CITIC and TigerMed.
Trimmune paid half of a $3.5M upfront fee ($1,750,000) today; HCW also received co-founder equity valued at approximately $3.5M (combined value ~$7.0M). Phase 1 in China is expected in H1 2027. HCW retains a royalty-free option to recapture Americas rights after Phase 1.
HCW Biologics (NASDAQ: HCWB) announced a warrant inducement agreement dated Nov 19, 2025 that amends exercise prices and triggers immediate exercises of prior warrants.
The investor agreed to a reduced exercise price of $2.66 for November 2024 and May 2025 warrants, resulting in exercises to purchase 167,925 and 1,342,280 shares respectively, with gross proceeds of approximately $4.0 million before fees. In return, HCW will issue 3,020,410 unregistered new warrants exercisable at $2.41, expiring 5.5 years after original issuance.
The closing is expected on or about Nov 20, 2025, Maxim Group LLC is financial advisor, and the company has agreed to file a registration statement covering resale of shares underlying the new warrants.
HCW Biologics (NASDAQ: HCWB) announced the first patient was dosed on Nov 18, 2025 at The Ohio State University Wexner Medical Center in a Company‑sponsored, multi‑center, first‑in‑human Phase 1 trial of HCW9302 for alopecia areata (NCT07049328).
HCW9302 is a subcutaneous interleukin‑2 fusion molecule designed to activate and expand regulatory T cells (Treg) to reduce autoimmune inflammation. The dose‑escalation study plans to treat up to 30 patients; primary goals are safety and determining a recommended Phase 2 dose. Secondary endpoints include disease response and effects on Treg proliferation and function.
HCW Biologics (NASDAQ: HCWB) reported Q3 2025 results and business highlights on Nov 14, 2025. The company expects to dose the first patient in a Phase 1 study of HCW9302 in Q4 2025 and opened two clinical sites for an alopecia areata trial. During Q3 the company issued 475,000 shares for $2.2M under its standby equity purchase agreement.
Q3 revenue was $15,606 (Q3 2024: $426,423); nine-month revenue was $27,222 (9M 2024: $2.2M). Q3 net loss was $4.6M; nine-month net loss was $8.7M. Management stated substantial doubt about going concern without additional funding and faces a Nasdaq equity-rule cure deadline of Dec 31, 2025.
HCW Biologics (NASDAQ: HCWB) presented updated preclinical data for its tetra-valent, pembrolizumab-based immune checkpoint inhibitor HCW11-040 at SITC2025 (Nov 5–9, 2025).
HCW11-040 is a multi-functional fusion protein combining pembrolizumab with IL-15, IL-7 domains and a TGF-β trap. Preclinical results reported: PD-1/PD-L1 blockade equivalent to pembrolizumab, superior expansion/activation of TPEX and memory T cells, enhanced human PBMC anti-tumor activity in organoid models, no evidence of excessive inflammatory responses after subcutaneous dosing, and a streamlined GMP-like manufacturing process.
HCW Biologics (NASDAQ: HCWB) presented preclinical data for its tetra-valent, TRBC-based T‑Cell Engager (TCE) program at the SITC 40th Annual Meeting (Nov 5–9, 2025) in National Harbor, MD.
Key points: the lead candidate HCW11-018b showed tumor shrinkage in xenograft and PDX models, 100% survival in treated tumor-bearing mice versus 0% in untreated controls, activation of exhausted tumor‑infiltrating T cells, favorable tolerability and long serum half-life in non‑human primates, subcutaneous dosing, and a streamlined GMP manufacturing process without Fc fusion.
HCW Biologics (NASDAQ: HCWB) announced its Chief Scientific Officer, Peter Rhode, PhD, participated in a Virtual Investor “What This Means” segment highlighting the company’s lead candidate HCW11-040, a pembrolizumab-based, tetra-specific fusion protein built on the TRBC platform.
HCW11-040 combines pembrolizumab with interleukin-7, interleukin-15, and TGF-β receptor components (TGF-β traps). Preclinical testing reportedly shows expansion of exhausted T cells (TPEX) without causing side effects. Detailed preclinical data will be presented in a poster at SITC on November 8, 2025.
HCW Biologics (NASDAQ: HCWB) announced it will participate in the 2025 Maxim Growth Summit held October 22–23 at The Hard Rock Hotel NYC.
Founder and CEO Dr. Hing C. Wong will meet one-on-one with institutional investors and senior Maxim analysts; the program includes CEO roundtables and keynote speakers. The company described the event as an opportunity to discuss its clinical-stage immunotherapy programs linking chronic inflammation and disease.