HCW Biologics has successfully closed a $5 million follow-on offering to advance its pipeline of novel immunotherapies targeting age-related and inflammation-driven diseases. The financing, completed on May 15, 2025, will primarily support the company's upcoming Phase 1 clinical trial of HCW9302 in autoimmune disorders.
The Miramar, Florida-based clinical-stage biopharmaceutical company priced its offering at $7.45 per unit, with each unit consisting of one share of common stock (or pre-funded warrant) and two warrants to purchase additional shares. Maxim Group LLC acted as the sole placement agent for the transaction.
"We are pleased to have completed a successful $5.0 million equity offering in a difficult market without using a highly structured deal," said Dr. Hing Wong, Founder and CEO of HCW Biologics. "This funding will be used to open clinical sites for our Phase 1 clinical trial to evaluate HCW9302 in an autoimmune disorder."
Advancing Novel Immunotherapy Platforms
HCW Biologics has developed two proprietary technology platforms that have yielded over 50 immunotherapeutic compounds. The company's lead candidate, HCW9302, was developed using its legacy TOBI™ (Tissue factOr-Based fusIon) platform and recently received FDA clearance to initiate a first-in-human Phase 1 dose escalation trial in patients with moderate-to-severe alopecia areata.
The company has also created the TRBC platform, which enables the development of multiple classes of immunotherapeutics:
- 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
Among the promising candidates from this platform are HCW11-002, HCW11-018, and HCW11-027, which are currently undergoing preclinical evaluation.
Strategic Business Development Initiatives
A significant portion of the new funding will support business development efforts aimed at identifying licensing partners for the company's immune cell engagers, including T-cell engagers created using the TRBC platform.
HCW Biologics is also making progress on existing partnerships. On May 13, 2025, the company delivered a technology report to WY Biotech in accordance with their exclusive worldwide licensing agreement for HCW11-006, a preclinical drug built with the TRBC platform. Following a 30-day due diligence period, HCW Biologics expects to recognize revenue from a $7.0 million upfront licensing fee.
Promising CAR-T Manufacturing Technology
The company is particularly excited about the commercial potential of HCW9206, a clinical-stage molecule that could revolutionize CAR-T cell manufacturing. Recent studies presented by research collaborators from Albert Einstein College of Medicine at the 2025 Annual Meeting of American Association of Immunologists demonstrated that HCW9206 could generate CAR-T cells with stem cell-like memory phenotypes.
"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," explained Dr. Wong. "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."
This technology could potentially enhance the persistence of CAR-T cells in patients, improving long-term survival of disease-specific CAR-Ts and enabling sustained suppression of malignancies, chronic infections, and autoimmune diseases—all while lowering manufacturing costs.
Financial Position and Outlook
The company reported a net loss of $2.2 million for the first quarter of 2025, a significant improvement from the $7.5 million loss in the same period of 2024. This improvement was primarily due to a $2.0 million insurance reimbursement related to legal expenses and a 30% decrease in research and development expenses.
Despite these positive developments, HCW Biologics acknowledged that substantial doubt exists regarding its ability to continue as a going concern for at least 12 months without additional funding. The company has implemented a multi-step financing plan and has had some early success, including the recent $5 million offering and regaining compliance with Nasdaq listing requirements.
"Our new round of financing will provide funding for critical studies to complete the research package for our business development campaign," said Dr. Wong, highlighting the company's strategy to leverage its extensive portfolio of proprietary molecules through licensing and other business development transactions.
As HCW Biologics advances its clinical programs and business development initiatives in the second half of 2025, the company remains focused on its mission to develop novel immunotherapies that address the link between inflammation and age-related diseases, potentially improving patients' quality of life and extending longevity.
