HCW Biologics Completes Deliverable and Solidifies License Agreement with WY Biotech

Rhea-AI Summary

HCW Biologics (NASDAQ: HCWB) has successfully completed a technology transfer with WY Biotech, solidifying their license agreement for HCW11-006, a novel immunotherapy molecule. The deal includes a $7.0 million upfront payment to be recognized in Q2 2025, plus potential milestone payments and double-digit royalties on future sales. HCWB retains a cost-free option to reclaim development rights for the Americas after Phase 1 trials. WY Biotech will bear all development and commercialization costs outside the opt-in territory. HCW11-006, developed on HCWB's TRBC platform, has shown promising preclinical results in solid tumor models, effectively stimulating anti-tumor immune responses without significant side effects.

Positive

• Secured $7.0 million upfront payment to be recognized in Q2 2025
• Eligible for additional milestone payments and double-digit royalties on future sales
• Retained cost-free option to recapture rights for Americas post-Phase 1
• No development costs outside opt-in territory as WY Biotech bears all expenses
• Preclinical studies showed effectiveness against solid tumors without unwanted side effects

Negative

• Will bear development and commercialization costs if opt-in rights are exercised for Americas
• Limited to Americas region in opt-in rights, losing potential global market access

Insights

Biotechnology Licensing Analyst

HCW Biologics secures $7M upfront payment and future revenue streams through WY Biotech partnership for HCW11-006, strengthening financial position.

The license agreement between HCW Biologics and WY Biotech has been solidified with completion of technology transfer requirements, triggering an immediate $7 million revenue recognition in Q2 2025. This deal structure represents a strategically favorable arrangement for HCW Biologics with multiple value-generating components.

The agreement's financial terms are particularly compelling: beyond the upfront payment, HCW Biologics stands to receive significant development milestone payments, double-digit royalties on future sales, and a share of proceeds from any future transactions involving HCW11-006. Most importantly, HCW has maintained a no-cost option to recapture development and commercialization rights for major Western Hemisphere markets after Phase 1 completion.

This deal structure effectively transfers development risk to WY Biotech, which assumes financial responsibility for research, manufacturing, clinical development, regulatory approval, and commercialization costs. HCW only incurs development costs if it exercises its territorial opt-in rights, creating an asymmetric risk-reward profile favoring HCW.

HCW11-006, a Multi-Functional Immune Cell Stimulator created on the company's TRBC platform, has demonstrated promising preclinical efficacy in solid tumor models, inducing anti-tumor CD8+ T cell and NK cell responses without significant side effects. This partnership represents both immediate financial benefit and strategic pipeline advancement for HCW's immunotherapy platform targeting inflammation and age-related diseases.

HCW Biologics earned upfront payment and will recognize revenue of $7.0 million in Q2 2025

MIRAMAR, Fla., June 04, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (“HCWB” 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, and WY Biotech Co., Ltd., a China-based company specializing in the early-stage development of recombinant protein drugs and gene/cell therapies, announced today that WY Biotech has completed its due diligence related to HCWB’s technology transfer report, including the characterization of the cell line, delivered on May 13, 2025. In addition, WY Biotech confirmed its commitment to proceed with the development and commercialization of the licensed molecule, HCW11-006, for in vivo therapeutic applications. The Agreement is now fully binding and HCW Biologics has earned the $7.0 million upfront license fee under the terms of the Agreement, as amended.

In addition to the $7.0 million upfront payment, HCWB is eligible to receive additional significant development milestone payments and double-digit royalties on future product sales. Furthermore, HCWB will share a substantial portion of the proceeds from a future transaction(s) involving the molecule, if such a transaction occurs. HCWB also has a payment-free, milestone-free, and royalty-free option to recapture the development and commercialization rights of this molecule for the United States, Canada, Central America, and South America (Opt-in Territory) after the conclusion of the Phase 1 clinical trial. WY Biotech is financially responsible for all costs associated with research and development, manufacturing, clinical development, regulatory approval, and commercialization for the molecule. HCWB will be responsible for costs associated with clinical development, regulatory approval, and commercialization in the Opt-in Territory, if HCWB exercises its opt-in rights. Both companies will work cooperatively in the development stage with a global focus for clinical development and partnering.

Dr. Hing C. Wong, Founder and Chief Executive Officer of HCW Biologics, stated, “We have a strategic focus to establish commercialization partnerships for our novel protein and antibody therapies with innovative leaders in the immunotherapy field. HCW11-006, the product candidate subject to the license with WY Biotech, combines several different immune functional domains on HCW Biologics’ TRBC drug discovery and development platform as part of a group of compounds characterized as Multi-Functional Immune Cell Stimulators. Preclinical studies demonstrated that HCW11-006 is highly effective at inducing anti-tumor CD8+ T cell and NK cell responses without triggering unwanted side effects in relevant solid tumor animal models.”

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 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 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 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 potential for a future transaction and sharing proceeds therefrom; the ability for HCWB to recapture and commercialize rights in certain territories; the ability of HCW11-006 to induce anti-tumor CD8+ T cell and NK cell responses; . 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, the latest Form 10-Q filed with the SEC on May 15, 2025 and in other filings filed from time to time with the SEC.

Company Contact: 

Lee Flowers
Senior Vice President, Business Development
HCW Biologics Inc.
LeeFlowers@HCWBiologics.com

FAQ

What is the value of HCWB's license agreement with WY Biotech?

The agreement includes a $7.0 million upfront payment, additional development milestone payments, and double-digit royalties on future product sales.

What is HCW11-006 and what are its potential benefits?

HCW11-006 is a Multi-Functional Immune Cell Stimulator that has shown effectiveness in inducing anti-tumor immune responses without unwanted side effects in preclinical solid tumor models.

What territories are covered in HCWB's opt-in rights?

HCWB has opt-in rights for the United States, Canada, Central America, and South America after Phase 1 clinical trials.

Who will pay for the development costs of HCW11-006?

WY Biotech will cover all development and commercialization costs outside the opt-in territory, while HCWB will be responsible for costs in the opt-in territory if they exercise their rights.

When will HCWB recognize the revenue from the WY Biotech agreement?

HCWB will recognize the $7.0 million upfront payment revenue in Q2 2025.