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Imagine a tiny, clinical-stage Bristol Myers Squibb, but entirely focused on discovering novel immunotherapies for cancer.

Think of it as an early-stage BioNTech or Moderna, but developing immune-modulating cancer drugs rather than vaccines.

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• HCW9218: A novel, bifunctional fusion protein designed to activate the innate and adaptive immune systems, currently in clinical trials for treating solid tumors.
• TOVAK™ (HCW9302): A bifunctional fusion protein in preclinical development aimed at treating chronic inflammation and age-related diseases.
• HCW9201: An allogeneic, off-the-shelf natural killer (NK) cell-based therapy in preclinical development for metastatic cancers.

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HCW Biologics (HCWB) is a clinical-stage biotechnology company primarily focused on the discovery and development of novel immunotherapies for cancer and other diseases. As a clinical-stage company, it does not currently have commercialized products or services on the market.

Therefore, HCW Biologics does not have major commercial customers in the traditional sense (i.e., companies or individuals purchasing its products or services).

Based on its latest financial filings (e.g., Form 10-K), HCWB's primary source of revenue is derived from:

• Government Grants: HCW Biologics receives grant revenue in connection with research and development services performed under grant agreements. Its major grant-providing institutions, which serve as its primary source of current operational funding, are:
  • The National Cancer Institute (NCI)
  • The National Institute of Allergy and Infectious Diseases (NIAID)
  Both the NCI and NIAID are components of the National Institutes of Health (NIH), which is a part of the U.S. Department of Health and Human Services. These are government agencies/institutions, not public companies, and therefore do not have stock symbols.

The company's business model at this stage is centered on advancing its drug candidates through clinical trials, with potential future revenue streams from licensing agreements, collaborations with larger pharmaceutical companies, or eventual commercialization of approved therapies.

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• Grand River Aseptic Manufacturing, Inc.
• Wacker Biotech GmbH
• Lonza Ltd. (SWX: LONN)
• Catalent, Inc. (NYSE: CTLT)

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Hing C. Wong, Ph.D., Chief Executive Officer

Dr. Hing C. Wong has served as the CEO of HCW Biologics since founding the company in April 2018. Prior to HCW Biologics, he founded and served as the Chief Executive Officer of Altor BioScience Corporation from 2002 until its acquisition by NantCell, Inc. (later ImmunityBio, Inc.) in August 2017. Following the acquisition, he served as the CEO of NantCell until March 2018. Dr. Wong also founded and was CEO of Sunol Molecular Corporation from 1996 to 2002, which was later acquired by Altor BioScience Corp. Earlier in his career, he held senior positions at Baxter Healthcare Inc. and Cetus Corporation.

Rebecca Byam, CPA, M.B.A., Chief Financial Officer

Rebecca Byam has been the Chief Financial Officer since October 2019. Before joining HCW Biologics, Ms. Byam was a Director at PricewaterhouseCoopers LLP from 2003 to 2019. Her previous experience includes serving as the Chief Financial Officer of MaMaMedia Inc. from 1998 to 2002 and Momentum Partners from 1995 to 1998. She also worked as an Investment Professional at Apax Partners LLP from 1985 to 1995, where she specialized in biotechnology investments.

Peter Rhode, Ph.D., Chief Scientific Officer & VP of Clinical Operations

Nicole Valdivieso, Esq., Vice President of Legal Affairs

Lee Flowers, Senior Vice President of Business Development

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The key risks to HCW Biologics (HCWB) are primarily financial, stemming from severe liquidity issues and operational dependencies inherent to a clinical-stage biotechnology company.

1. Severe Liquidity and Going Concern Doubt: HCW Biologics faces significant liquidity risks, with management explicitly expressing "substantial doubt" about its ability to continue as a going concern without securing additional funding. As of June and September 2025, the company's cash reserves were critically low ($2.4 million and $1.1 million, respectively), while total liabilities far exceeded assets. The company has a history of negative equity, substantial unpaid legal fees, and significant cash burn from operations. Its revenue has dramatically collapsed, largely due to the suspension of a key licensing agreement, leading to minimal income against high operating losses. The company relies heavily on external financing, making it vulnerable to market volatility and further equity dilution.
2. Clinical Trial Dependency and Development Risks: As a clinical-stage biopharmaceutical company, HCW Biologics' valuation and future prospects are heavily tied to the successful progression and outcomes of its clinical pipeline, particularly its lead candidate, HCW9302. The Phase 1 trial for HCW9302 (targeting alopecia areata) is a pivotal milestone. Any delays, setbacks, or unfavorable data from these trials could significantly impact the company's stock price and its ability to secure future financing. Additionally, the ability to continue development of other candidates like HCW9218 depends on a supply agreement with a third party, which as of May 2025 had not been drafted, posing another potential delay.
3. Nasdaq Compliance and Revenue Concentration: HCW Biologics has faced challenges maintaining compliance with Nasdaq listing rules, including the equity rule, and remains under a "Panel Monitor" through June 2026. Non-compliance could lead to delisting, severely impacting the company's market access and investor confidence. Furthermore, the company has historically been dependent on a single primary revenue stream from a licensing agreement with Wugen, which was suspended, causing a significant collapse in revenue. This concentration creates substantial execution risk, as any disruption with a key partner can severely impact the company's financial stability.

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HCW Biologics (HCWB) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies to address chronic inflammation and age-related diseases, including cancer and autoimmune conditions. The company's main product candidates are HCW9218 and HCW9302.

HCW9218 (Cancer Immunotherapy)

HCW9218 is a bifunctional immunotherapeutic currently in clinical development for various solid tumor cancers, including pancreatic, ovarian, breast, prostate, and colorectal cancers. While specific market sizing for HCW9218 is not available as it is still in clinical trials, the broader market it aims to enter, immune checkpoint inhibitors (ICIs), generated significant revenue. In 2024, immune checkpoint inhibitors achieved over $40 billion in worldwide sales. HCW Biologics is developing next-generation ICIs to compete in this substantial global market.

HCW9302 (Autoimmune Diseases, including Alopecia Areata)

HCW9302 is an interleukin-2 (IL-2) fusion protein complex in Phase 1 clinical trials for autoimmune and proinflammatory diseases, with a specific focus on alopecia areata. The global market for autoimmune disease therapeutics is projected to reach $215 billion by 2033, growing at a compound annual growth rate (CAGR) of 3.7% from 2025 to 2033. Another estimate indicates the global autoimmune disease therapeutics market was valued at $6.54 billion in 2024 and is expected to grow to $11.75 billion by 2032, with a CAGR of 7.6% from 2026 to 2032. North America held the largest share of the autoimmune disease therapeutics market in 2024, accounting for approximately 44% of the revenue. The United States specifically represents the largest share of this global market.

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Here are 3-5 expected drivers of future revenue growth for HCW Biologics (HCWB) over the next 2-3 years:

1. Upfront Payments and Milestone Payments from New Licensing Agreements: HCW Biologics expects to receive a $7.0 million upfront licensing fee from WY Biotech Co., Ltd. for HCW11-006, with the payment anticipated by September 30, 2025. Additionally, HCW Biologics is eligible for further significant development milestone payments and double-digit royalties on future product sales from this agreement. The company is also actively seeking new corporate partners to license HCW9206, following a one-year suspension of its previous agreement with Wugen Inc., which could lead to new licensing revenues.
2. Advancement and Potential Commercialization of Pipeline Candidates: A key driver is the progression of HCW Biologics' lead product candidates, HCW9302 and HCW9218. The company plans to initiate a Phase 1 clinical trial for HCW9302 in patients with alopecia areata in the third quarter of 2025. This is particularly significant as alopecia areata currently lacks curative FDA-approved treatments, representing a substantial market opportunity upon successful development and commercialization. Furthermore, progress in cancer immunotherapy research, specifically a second-generation pembrolizumab-based therapy showing promising preclinical results against solid tumors like pancreatic and ovarian cancers, could also contribute to future revenue.
3. Expansion of Strategic Partnerships: HCW Biologics has been actively expanding its collaborations with other biotechnology firms and research institutions. These strategic alliances are crucial for accelerating the development of new treatments and expanding the company's market reach, which can lead to additional licensing opportunities and bolster investor confidence.

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