HCW Biologics Inc. (HCWB): Business Model Canvas [Dec-2025 Updated]

You're digging into HCW Biologics Inc. (HCWB) and need to know if this clinical-stage firm is a future winner or a funding risk, especially since their cash position stood at just $\mathbf{\$2.4 \text{ million}}$ by June 30, 2025. As an analyst who's seen this movie before, I can tell you their model hinges entirely on proving out their TOBI/TRBC platforms via costly trials-like the Phase 1 for HCW9302-to unlock licensing revenue, such as the $\mathbf{\$7.0 \text{ million}}$ upfront fee they snagged in June. It's a classic biotech gamble: high R&D spend ($\mathbf{\$4.1 \text{ million}}$ in nine months) funded by investor cash, not product sales, so let's map out the entire structure to see where the next dollar comes from and where the compliance pressure is mounting.

HCW Biologics Inc. (HCWB) - Canvas Business Model: Key Partnerships

You're looking at the critical external relationships that keep HCW Biologics Inc. moving, and honestly, the numbers here tell a story of recent restructuring and ongoing financial pressure. Here's the breakdown of the key players and the associated financial figures as of late 2025.

License Partner: WY Biotech Co. Ltd. / Beijing Trimmune Biotech Co., Ltd. (HCW11-006)

The worldwide license for HCW11-006 has seen a recent shift. WY Biotech Co. Ltd. completed its due diligence on May 29, 2025, solidifying the agreement and making HCW Biologics eligible to recognize a $7.0 million upfront license fee in Q2 2025. The payment deadline was set for September 30, 2025. However, by November 2025, the agreement was amended, assigning the license to Beijing Trimmune Biotech Co., Ltd..

Under the new terms with Trimmune, HCW Biologics is set to receive half of that upfront fee, amounting to $3.5 million. Trimmune is now financially responsible for all research and development, manufacturing, clinical development, regulatory approval, and commercialization costs outside the Opt-in Territory. If the transaction doesn't close by January 16, 2026, all rights revert to HCW Biologics. Beyond the upfront payment, HCW Biologics remains eligible for additional significant development milestone payments and double-digit royalties on future product sales.

Clinical Development Partners: CROs and Sites (HCW9302 Phase 1)

For the Phase 1 trial of HCW9302 in alopecia areata, the company is actively engaging clinical sites. The first patient was dosed at The Ohio State University Wexner Medical Center. The $5.0 million equity offering closed on May 15, 2025, is earmarked to fund the opening of these clinical sites. The IND clearance for this trial was received on January 28, 2025.

Suspended Partner: Wugen, Inc. (HCW9206)

The license agreement with Wugen, Inc. for HCW9206 was formally suspended for one year on May 30, 2025, running through May 29, 2026. This suspension relieved Wugen from its obligation to fund $250,000 per year for product development support. The historical revenue from this licensee collapsed, dropping from $1.7 million in the first half of 2024 to just $11,615 in the first half of 2025. As of June 30, 2025, HCW Biologics still held investments valued at $3,348,438 related to Wugen.

Capital Raising Agent: Maxim Group LLC

Maxim Group LLC served as the exclusive Financial Advisor for a warrant inducement transaction announced on November 19, 2025. This deal involved the exercise of warrants at a reduced price of $2.66 per share, expected to bring in gross proceeds of approximately $4.0 million. This follows a $5.0 million equity offering closed in May 2025.

Legal Counsel and Creditors

Ongoing discussions involve significant legal fee obligations. As of June 30, 2025, the company's accounts payable stood at $19,354,476, which included $12.3 million reported as unpaid legal fees. This relates to ongoing discussions regarding the $12.1 million in unpaid legal fees you mentioned [cite: Prompt]. For context, legal expenses for the twelve months ending December 31, 2024, totaled $15.9 million. A $2.0 million insurance reimbursement related to prior legal fees was received in January 2025.

You can map these relationships and their associated financial impacts in a table:

Partner Entity	Relationship Focus	Key Financial/Statistical Data Point (as of late 2025)	Status/Term Detail
Beijing Trimmune Biotech Co., Ltd.	Worldwide License (HCW11-006)	$3.5 million expected upfront payment (half of original $7.0M)	New licensee; rights revert if deal fails by January 16, 2026
WY Biotech Co. Ltd.	Original Licensee (HCW11-006)	Eligible for double-digit royalties	License assigned to Trimmune as of Nov 2025
Wugen, Inc.	License Agreement (HCW9206)	Wugen obligation relief: $250,000 per year funding	Suspended for one year from May 30, 2025 to May 29, 2026
The Ohio State University Wexner Medical Center	Phase 1 Clinical Trial Site (HCW9302)	First patient dosed in Q3-2025 expected trial	Site for first-in-human trial
Maxim Group LLC	Financial Advisor for Capital Raising	Advisor for $4.0 million gross proceeds warrant inducement	Acted as exclusive Financial Advisor in Nov 2025 transaction
Unidentified Law Firms	Legal Services Provider	Accounts payable includes $12.3 million in unpaid legal fees	Related to ongoing discussions regarding fees, following $15.9 million in legal expenses for 2024

You should track the receipt of the $3.5 million from Trimmune, as the company's cash at $2.44M on June 30, 2025, shows immediate need for inflows. Also, note that the $5.0 million equity raise in May 2025 was critical for funding operations and opening those clinical sites.

HCW Biologics Inc. (HCWB) - Canvas Business Model: Key Activities

You're looking at the core engine driving HCW Biologics Inc. (HCWB) right now-the activities they must execute daily to keep the lights on and the pipeline moving forward as of late 2025. It's a tightrope walk between discovery, clinical execution, and financial survival.

Drug discovery and preclinical development using TOBI and TRBC platforms.

The company's foundational activity rests on its proprietary technology platforms. HCW Biologics Inc. owns the TRBC drug discovery and development platform, which has been used to create over 50 compounds showing bioactivity. The lead candidate for autoimmune disease, HCW9302, is an IL-2 fusion molecule constructed using the legacy TOBI platform technology. The TRBC platform is versatile, enabling the creation of multiple classes of immunotherapeutics, including Class I: Multi-Functional Immune Cell Stimulators, Class II: Second-Generation Immune Checkpoint Inhibitors, and Class III: Multi-Specific Targeting Fusions and Enhanced Immune Cell Engagers. The market context for these activities is significant; the global immunotherapy market was valued at $185.72 billion in 2025, with a projected Compound Annual Growth Rate (CAGR) of 11.5%.

Key platform outputs and associated market context include:

• TRBC Platform Compounds Owned: Over 50.
• HCW9302 Construction Platform: Legacy TOBI.
• HCW11-006 Construction Platform: TRBC.
• Immunotherapy Market Value (2025): $185.72 billion.

Clinical trial execution, specifically the Phase 1 trial for HCW9302.

Active clinical execution is centered on HCW9302, the lead product candidate for autoimmune diseases. The company announced the dosing of the first patient in the Phase 1 clinical trial for HCW9302 on November 18, 2025. This trial, which is company-sponsored and multi-center, targets patients with alopecia areata, an autoimmune disorder. The primary goal of this Phase 1 study is to establish the safe dose that effectively increases regulatory T (Treg) cell activity in patients. To support this, the company opened two trial sites for HCW9302. The funding for these critical studies was bolstered by a $5.0 million equity offering closed in May 2025. The financial commitment to R&D reflects this focus, with Research and Development (R&D) expenses for the nine months ended September 30, 2025 totaling $4.1 million, representing a 23% decrease from $5.3 million in the prior year period.

Here's a snapshot of the recent clinical and R&D financial activity:

Metric	Value (As of Late 2025 Data)	Period/Context
First Patient Dosed (HCW9302)	November 18, 2025	Phase 1 Trial Initiation
R&D Expenses	$4.1 million	Nine Months Ended September 30, 2025
R&D Expense Change (Y/Y)	-23%	Nine Months Ended September 30, 2025 vs. 2024
Equity Financing Proceeds	$5.0 million	May 2025 Offering
Trial Sites Opened	2	For HCW9302 in Alopecia Areata

Business development to secure new out-licensing and collaboration deals.

Business development is a crucial activity, especially given the revenue profile. The company planned to ramp up these efforts in the second half of 2025. A key focus involves the molecule HCW11-006, which was constructed using the TRBC platform. An amended license agreement is in place with Beijing Trimmune Biotech (formerly WY Biotech). Under this new structure, HCW Biologics Inc. is set to receive half of a $7.0 million upfront license fee ($3.5 million) in cash upon closing, with the remainder in Trimmune equity. However, as of late 2025, ongoing discussions were reported regarding the $7.0 million upfront fee deadline with WY Biotech. The deal structure places financial responsibility for all R&D, manufacturing, clinical development, and commercialization costs for HCW11-006 in Trimmune's territory onto Trimmune. HCW Biologics retains a payment-free, milestone-free, and royalty-free option to recapture all rights for the Americas market after the conclusion of the Phase 1 clinical trial for HCW9302.

Intellectual property management and patent portfolio expansion.

This activity is inherently linked to the drug discovery platforms. The company's ownership of over 50 compounds created via the TRBC platform represents a significant, albeit early-stage, intellectual property asset base. The company's strategy balances in-house development (focusing on HCW9302 and second-generation immune checkpoint inhibitors) with licensing programs. The TRBC platform itself is a core IP asset, enabling the creation of molecules like HCW11-006, which is characterized as a Class I Multi-Functional Immune Cell Stimulator.

Financial management to maintain Nasdaq listing compliance.

Maintaining listing compliance is a top-tier operational activity. HCW Biologics Inc. successfully met Nasdaq's continued listing requirements as of May 2025, satisfying the Bid Price Rule, Public Float Rule, and Market Value of Publicly Held Shares (MVPHS) Rule. This was achieved following a $5.0 million equity financing and a $6.6 million Senior Note Conversion. However, the company remains under scrutiny. On October 13, 2025, the Nasdaq Hearings Panel granted an extension, requiring compliance with the Equity Rule by December 31, 2025, and all other rules by February 16, 2026. The underlying financial stress is evident in the balance sheet as of June 30, 2025, where current liabilities of $26.8 million exceeded current assets by $23.9 million (GAAP), with only $2.4 million in cash on hand. Furthermore, the company is engaged in discussions to arrange a payment plan for $12.1 million in unpaid legal fees related to an Arbitration. Revenue activity is also a concern; for the nine months ended September 30, 2025, revenues were only $27,222, a sharp drop from $2.2 million the prior year, largely due to a one-year suspension of the Wugen License Agreement. The net loss for that same nine-month period was $8.7 million.

You need to watch these compliance and liquidity figures closely:

• Nasdaq Compliance Deadline (Equity Rule): December 31, 2025.
• Cash Balance: $2.4 million (as of June 30, 2025).
• Current Liabilities: $26.8 million (as of June 30, 2025).
• Unpaid Legal Fees (Arbitration): $12.1 million.
• Nine-Month Revenue (9/30/2025): $27,222.

Finance: draft 13-week cash view by Friday.

HCW Biologics Inc. (HCWB) - Canvas Business Model: Key Resources

You're looking at the core assets that power HCW Biologics Inc. (HCWB) right now, late in 2025. These aren't just abstract concepts; they are the tangible and intellectual foundations supporting their entire operation.

Proprietary Drug Discovery Platforms

The engine room of HCW Biologics Inc. is its two proprietary technology platforms. These are the specialized tools used to generate their pipeline compounds. The legacy platform is the TOBI (Tissue factOr-Based fusIon) discovery platform, which was used to create the lead product candidate, HCW9302. The newer technology is the TRBC platform, which is not based on Tissue Factor and is used to engineer second-generation immunotherapies. The TRBC platform is a versatile scaffold, enabling the creation of Multi-Functional Immune Cell Stimulators, Second-Generation Immune Checkpoint Inhibitors, and Multi-Specific Targeting Fusions.

Pipeline and Lead Candidates

HCW Biologics Inc. has built a substantial portfolio of drug candidates. The company has stated it has created and owns over 50 compounds. The focus is on advancing specific lead candidates, with HCW9302 currently in a first-in-human Phase 1 dose escalation clinical trial for alopecia areata. Another key asset is HCW9218, described as an injectable, fusion protein complex designed for antitumor activity. Furthermore, HCW9206 is a clinical-stage molecule cited as ready for commercialization, intended to streamline and lower the costs of CAR-T manufacturing.

The pipeline strength is also demonstrated by specific molecules developed using the TRBC platform, such as HCW11-002, HCW11-018, and HCW11-027, which are undergoing further preclinical evaluation.

Intellectual Property and Licensing Assets

The value of the platforms is locked down by intellectual property. HCW Biologics Inc. holds a license to ten issued U.S. patents and four issued Japanese patents, among others. The company also has a significant number of pending applications globally, specifically 124 pending patent applications worldwide.

A major licensing asset involves HCW11-006, for which an exclusive worldwide license agreement was established, initially with WY Biotech and later amended with Beijing Trimmune Biotech. Under the Amended and Restated License Agreement with Trimmune, HCW Biologics Inc. is set to receive half of a $7.0 million upfront license fee in cash, amounting to $3.5 million at closing. This agreement also grants HCW Biologics Inc. a payment-free, milestone-free, and royalty-free option to recapture all rights for development and commercialization in the United States, Canada, Central America, and South America after the conclusion of the Phase 1 clinical trial for HCW11-006.

Here's a quick look at the IP and financial structure around that key license:

Asset/Metric	Detail	Value/Count
Licensed Molecule	HCW11-006 (for in vivo applications)	One molecule
Issued U.S. Patents Licensed	Ten	10
Pending Worldwide Patent Applications	Total	124
Upfront License Fee (Trimmune)	Total Expected	$7.0 million
Upfront Cash Received (Trimmune)	At Closing	$3.5 million

Financial Liquidity

Liquidity is a critical resource, especially for a clinical-stage company. As of June 30, 2025, HCW Biologics Inc.'s cash and cash equivalents stood at $2.4 million. To provide more precision, the actual reported figure was $2,438,962. This cash position is set against total current liabilities of $26.8 million as of the same date. The company completed a $5.0 million equity offering in May 2025 to fund operations, including the HCW9302 trial.

Scientific Expertise and Personnel

The human capital is centered on specialized scientific knowledge in immunotherapy development and inflammation-related diseases. The company is headquartered in Miramar, Florida, and employs 44 full-time employees. Key personnel include Dr. Hing Wong, the Founder and CEO. The expertise is directly applied to developing molecules that target chronic inflammation, or inflammaging, to treat conditions like cancer and autoimmune diseases.

Consider the operational expenses that this expertise drives:

• Research and Development Expenses (Six Months Ended June 30, 2025): $2.7 million.
• General and Administrative Expenses (Q2 2025): $2.1 million.
• General and Administrative Expenses (Six Months Ended June 30, 2025): $4.3 million.

If onboarding takes 14+ days, churn risk rises.

Finance: draft 13-week cash view by Friday.

HCW Biologics Inc. (HCWB) - Canvas Business Model: Value Propositions

You're looking at the core value HCW Biologics Inc. (HCWB) brings to the table-it's all about targeting the root cause of disease rather than just the symptoms. The central proposition is developing novel immunotherapies that disrupt the link between chronic inflammation and age-related diseases, aiming to not just treat conditions but potentially extend healthspan.

HCW9302 is their lead candidate for autoimmune issues, and it's now in human testing. This molecule is a subcutaneously injectable interleukin-2 fusion molecule designed to activate and expand regulatory T cells (Treg cells), which are key to controlling excessive inflammation. The value here is significant because for moderate-to-severe alopecia areata, there are currently no curative FDA approved treatments. Alopecia areata itself impacts approximately 160 million people worldwide, representing a lifetime incidence of about 2% of the global population. HCW Biologics dosed the first patient in its Phase 1 dose-escalation study, which aims to enroll up to 30 patients, in the fourth quarter of 2025, having confirmed the drug was well tolerated in non-human primate studies. The immediate goal is establishing the safe recommended Phase 2 dose.

For the cell therapy space, HCW9206 offers a revolutionary reagent proposition. It's designed to streamline and lower the costs of CAR-T manufacturing by replacing traditional anti-CD3/anti-CD28/IL-2-based approaches. The benefit is generating CAR-T cells with a stem cell-like memory phenotype (Tscm), which is expected to improve durability and efficacy-a goal that has been elusive for the last decade. While HCW Biologics seeks a new licensing partner after suspending the Wugen License Agreement, the potential cost impact is huge; in other settings, CAR-T therapy has been associated with medical costs being 7.0% to 46.0% lower and pharmacy costs reduced by 56.9% to 88.1% compared to later-line non-CAR T treatments. HCW9206 is positioned to amplify those cost-saving and efficacy benefits in the manufacturing process itself.

When we look at oncology, HCW9218 is focused on enhancing anti-tumor efficacy in solid tumors, particularly those that are chemo-refractory. This bifunctional fusion protein works by activating immune cells and trapping the immunosuppressive factor TGF-β. Early data from a Phase 1 study showed that in ovarian cancer patients, over 70% (5 out of 7) showed evidence of stable disease. Furthermore, 87% (13 out of 15) of patients in one cohort had failed more than 4 lines of prior therapy, showing it targets a high-need population. The mechanism is supported by data showing it significantly reduced blood levels of TGF-β in a dose-dependent manner.

Here's a quick look at the pipeline assets and their quantified value drivers as of late 2025:

Asset	Indication/Use	Key Quantifiable Value Proposition Metric	Development Stage (Late 2025)
HCW9302	Moderate-to-Severe Alopecia Areata	Addresses market of 160 million people with no curative treatment	Phase 1 Dosing Initiated (up to 30 patients)
HCW9206	CAR-T Manufacturing Reagent	Aims to lower costs and improve persistence (compared to traditional methods)	Seeking new commercial licensing partner
HCW9218	Advanced Solid Tumors	70% stable disease rate in ovarian cancer cohort (5/7) in Phase 1	Phase 1/1b data readout complete/ongoing

The overarching value proposition ties directly into the company's mission: improving the quality of life for patients suffering from debilitating autoimmune conditions like alopecia areata, and potentially offering new avenues for cancer patients who have exhausted 4 or more prior therapies. By targeting the underlying inflammation and senescence pathways, HCW Biologics Inc. is positioning its pipeline to offer treatments that could lead to a longer, healthier life, which is the ultimate measure of extended healthspan.

HCW Biologics Inc. (HCWB) - Canvas Business Model: Customer Relationships

You're managing the relationships for HCW Biologics Inc. (HCWB) in late 2025, which means keeping key external stakeholders aligned while navigating active clinical development and ongoing financing needs. The focus here is on the quality and structure of those interactions, backed by the hard numbers from recent quarters.

High-touch, collaborative relationships with biopharma licensees and partners define a core part of HCW Biologics Inc.'s strategy, especially for out-licensing their proprietary molecules developed via the TOBI™ discovery platform. The relationship with their existing licensee, Wugen, saw a significant shift; the Company agreed to a one-year suspension of the Wugen License Agreement on May 29, 2025, during which time HCW Biologics Inc. is seeking alternative licensing programs for HCW9206. Separately, the Company is actively negotiating with several major potential partners for HCW9206. A key potential partner, WY Biotech, accepted the technology report on May 30, 2025, with an expected upfront license fee of $7.0 million due by September 30, 2025; however, this fee remained unpaid as of October 16, 2025.

This licensing focus directly impacts reported revenue. For the three months ended September 30, 2025, revenues were only $15,606, derived exclusively from the sale of licensed molecules to Wugen. This contrasts sharply with the $426,423 reported for the same period in 2024.

Relationship/Transaction Metric	Value/Amount	Date/Period
Gross Proceeds from May 2025 Equity Offering	$5.0 million	May 15, 2025
Debt Extinguished via Restructuring/Conversion	$7.7 million	May 7, 2025
Gross Proceeds from Warrant Inducement	Approximately $4.0 million	November 2025
Expected Upfront License Fee from WY Biotech	$7.0 million	Expected by September 30, 2025
Q3 2025 Net Loss	$4.6 million	Three months ended September 30, 2025
Shares from May 2025 Warrants Exercised	1,342,280 shares	November 2025

Direct engagement with clinical investigators and research collaborators is currently centered on advancing the lead candidates. The first patient was dosed in the company-sponsored, multi-center Phase 1 clinical trial for HCW9302 in an autoimmune disorder on November 18, 2025. This trial, NCT07049328, targets patients with moderate-to-severe alopecia areata. Furthermore, HCW Biologics Inc. shared the latest data for its second-generation Immune Checkpoint Inhibitor at the 40th Annual Meeting of the Society for Immunotherapy of Cancer in November 2025. For the other lead molecule, HCW9218, Phase 1 trials are enrolling patients in studies for chemo-refractory/chemo-resistant solid tumors (NCT05322408) and advanced pancreatic cancer (NCT05304936).

Investor relations is necessarily focused on transparency regarding financing and compliance, given the recent challenges. The Company closed a $5.0 million equity offering in May 2025 and entered a warrant inducement agreement in November 2025 for gross proceeds of approximately $4.0 million. To address listing concerns, the Nasdaq Hearings Panel granted an extension on October 13, 2025, requiring HCW Biologics Inc. to demonstrate compliance with the Equity Rule by December 31, 2025. On the day of the November warrant inducement announcement, the stock closed at $2.92, resulting in a market capitalization of $7M.

Regulatory relationship management with the FDA for IND clearance has seen a major success this year. HCW Biologics Inc. announced receipt of FDA clearance for the Investigational New Drug Application for HCW9302 on February 3, 2025. This clearance allowed the initiation of the first-in-human Phase 1 dose escalation clinical trial for this candidate, which is an injectable, first-in-kind interleukin 2 fusion protein complex.

• IND Clearance Date for HCW9302: February 3, 2025.
• Indication for Phase 1 Trial: Moderate-to-severe alopecia areata.
• First Patient Dosed Date: November 18, 2025.
• Total Employees: 11-50.

Finance: draft 13-week cash view by Friday.

HCW Biologics Inc. (HCWB) - Canvas Business Model: Channels

Direct out-licensing agreements with pharmaceutical and biotech companies.

HCW Biologics Inc. entered into an Amended and Restated License, Research and Co-Development Agreement with Beijing Trimmune Biotech Co., Ltd. on November 19, 2025, concerning molecule HCW11-006. Under these terms, HCW Biologics Inc. is set to receive half of a $7.0 million upfront license fee, equating to $3.5 million in cash at closing. Trimmune assumes financial responsibility for all research and development, manufacturing, clinical development, regulatory approval, and commercialization costs for HCW11-006 in its designated territory. HCW Biologics Inc. retains a payment-free, milestone-free, and royalty-free option to recapture all rights for HCW11-006 for in vivo applications in the United States, Canada, Central America, and South America following the conclusion of the Phase 1 clinical trial.

The company also had an exclusive worldwide licensing agreement with WY Biotech for HCW11-006, where HCW Biologics Inc. expected to recognize revenue for a $7.0 million upfront licensing fee after WY Biotech completed its due diligence, which concluded around May 30, 2025. However, revenues derived from the Wugen License Agreement were impacted, as HCW Biologics Inc. agreed to a one-year suspension of that agreement as of the third quarter ended September 30, 2025. This suspension contributed to GAAP revenue falling sharply to $6,550 in the second quarter of 2025, compared to $618,854 in the second quarter of 2024.

License/Agreement Partner	Molecule(s) Involved	Upfront Fee Component	Status/Key Date
Beijing Trimmune Biotech Co., Ltd.	HCW11-006	$3.5 million cash portion of $7.0 million total	Amended Agreement signed November 19, 2025
WY Biotech	HCW11-006	Potential $7.0 million recognized upon due diligence completion	Due diligence concluded May 30, 2025
Wugen	HCW9206 (component)	Revenue stream suspended	One-year suspension agreed as of Q3 2025

Scientific publications and conference presentations (e.g., SITC) to showcase data.

HCW Biologics Inc. utilized major scientific conferences to disseminate preclinical data for its pipeline candidates. The company presented data for its tetra-valent, second-generation Immune Checkpoint Inhibitor (ICI) HCW11-040 at SITC2025, which took place from November 5 to 9, 2025. Furthermore, data for the second-generation T-Cell Engager (TCE) Program candidate, HCW11-018b, was presented at the SITC 40th Annual Meeting during the same period. The company has developed over 50 molecules utilizing its proprietary TRBC platform technology.

• SITC 40th Annual Meeting dates: November 5 to 9, 2025
• HCW11-040 data presented at SITC2025
• HCW11-018b data presented at SITC 40th Annual Meeting
• Total molecules constructed using the TRBC platform: Over 50

Clinical trial sites for drug testing and data generation.

The company-sponsored, multi-center first-in-human Phase 1 clinical trial for HCW9302, evaluating the drug in patients with alopecia areata (NCT07049328), reached a milestone with the dosing of the first patient on November 18, 2025. The initial patient was dosed at The Ohio State University Wexner Medical Center. The funding from a May 2025 equity offering was earmarked to open clinical sites for this Phase 1 trial.

Investor roadshows and equity offerings for capital access.

HCW Biologics Inc. executed financing activities to support clinical development. On May 15, 2025, the company closed an equity offering, securing gross proceeds of $5.0 million from a single institutional investor. This offering involved 671,140 units priced at $7.45 per unit. Earlier, on May 7, 2025, the company strengthened its balance sheet by extinguishing $7.7 million of debt through restructuring or conversion to equity. More recently, on November 19, 2025, HCW Biologics Inc. entered an agreement for the immediate exercise of outstanding warrants, expected to yield gross proceeds of approximately $4.0 million before fees, at an amended exercise price of $2.66 per share. Despite these capital raises, as of September 30, 2025, the company stated that substantial doubt exists regarding its ability to continue as a going concern for at least 12 months without additional funding.

Financing Summary (2025)

Financing Event	Date	Gross Proceeds/Amount	Key Metric
Equity Offering	May 15, 2025	$5.0 million	$7.45 per unit price
Debt Extinguishment	May 7, 2025	$7.7 million	Restructuring or conversion to equity
Warrant Exercise Inducement	November 19, 2025	Approximately $4.0 million expected	Amended exercise price of $2.66

HCW Biologics Inc. (HCWB) - Canvas Business Model: Customer Segments

Global biopharmaceutical companies seeking novel immunotherapy assets.

• Targeted by the business development campaign to identify a licensing partner for Immune-Cell Engagers, including T-Cell Engagers.
• Demonstrated by the fully binding worldwide exclusive license agreement with WY Biotech for HCW11-006, which earned HCW Biologics Inc. a $7.0 million upfront license fee.
• The Company has over 50 compounds created and owned using the TRBC drug discovery and development platform.

Clinical research organizations (CROs) and academic medical centers.

Operational Metric	Value as of Late 2025 (Q3/Anticipated)	Context
Phase 1 Trial Sites Active	2	Actively screening patients for HCW9302 in alopecia areata.
HCW9302 Dosing Target	Fourth quarter of 2025	Initiation of first-in-human Phase 1 clinical study (NCT07049328).
R&D Expenses (9 Months Ended Sept 30, 2025)	$4.1 million	Reflects costs for clinical-stage molecule development.

Institutional and individual investors in the high-risk biotech sector.

• Financing activity included a $5.0 million gross proceeds equity offering closed in May 2025.
• Stock performance showed a trend up by 98.49% on August 25, 2025.
• Consensus analyst EPS forecast for 2025Q4 is -1.770.
• Total Assets as of June 30, 2025, were $28.9 million.

Future patients with chronic inflammatory diseases and cancer.

• Primary focus is on developing immunotherapies to lengthen healthspan by disrupting the link between inflammation and diseases.
• Lead candidate HCW9302 targets autoimmune diseases, with initial focus on alopecia areata, which currently has no curative FDA approved treatments.
• The Company is also launching a search for partners for its T-cell engager (TCE) compounds designed to target cancer antigens.
• Net Loss for the three months ended September 30, 2025, was $4.6 million.

HCW Biologics Inc. (HCWB) - Canvas Business Model: Cost Structure

You're looking at the core expenditures for HCW Biologics Inc. (HCWB) as they push their pipeline forward, especially with the lead candidate HCW9302 moving toward first-in-human trials. For a clinical-stage biotech, the cost structure is heavily weighted toward science and compliance. Here's the quick math on the major buckets based on the nine months ended September 30, 2025, financial results.

The primary operational costs are concentrated in Research and Development and the overhead required to run a public company. The R&D spend reflects the ongoing work on their novel immunotherapies designed to disrupt inflammaging (chronic, low-grade inflammation associated with aging). Clinical trial costs for HCW9302, the subcutaneously injectable IL-2 fusion molecule, are embedded within these figures, as the company anticipated dosing the first patient in a Phase 1 study in the fourth quarter of 2025.

Cost Category	Period Ended September 30, 2025	Comparative Data Point
Research and Development (R&D) Expenses	$4.1 million (or $4,109,782)	A decrease of 23% compared to the $5.3 million in the same period in 2024.
General and Administrative (G&A) Expenses	$6.2 million (or $6,187,296)	An increase of 29% compared to the $4.8 million in the same period in 2024.
Legal Expenses (Recoveries), Net	Net Contra Expense of ($1.6) million (or ($1,590,945))	This indicates a net recovery/offset for the nine months, contrasting with $15.8 million in expenses for the same period in 2024.

The G&A spend saw a notable jump, which often happens as a company scales up compliance and operational readiness for clinical trials. For the three months ended September 30, 2025, G&A was $1.9 million.

Maintaining a public listing on Nasdaq requires specific, recurring expenditures. While the company regained compliance with listing requirements in Q2 2025, the associated professional services and compliance costs are factored into the G&A line item. To support operations and potentially fund near-term milestones, HCW Biologics Inc. entered into a $4.0 million warrant inducement transaction in November 2025.

A significant, non-recurring cost pressure relates to past legal matters and balance sheet clean-up. You need to track these liabilities closely, as they impact cash flow planning, even if they aren't direct R&D spend.

• Unpaid legal fees requiring a payment plan were noted to be $12.3 million as of the Q2 2025 report.
• Debt restructuring activities in Q2 2025 included the extinguishment of $7.7 million in debt.
• Legal expenses for the nine months ended September 30, 2025, were a net recovery of approximately ($1.6) million.

The cost structure is clearly that of a company prioritizing its lead asset, HCW9302, while managing legacy financial obligations. Finance: draft 13-week cash view by Friday.

HCW Biologics Inc. (HCWB) - Canvas Business Model: Revenue Streams

You're looking at the hard numbers that drive the top line for HCW Biologics Inc. as of late 2025. The revenue picture is clearly split between realized upfront payments, minimal legacy revenue due to a major shift, and essential capital raises.

Upfront Licensing Fees

The most significant recent cash event tied to a licensing deal was the upfront fee from the WY Biotech agreement for HCW11-006. HCW Biologics Inc. formally recognized revenue of $7.0 million from WY Biotech in June 2025, following the completion of WY Biotech's due diligence.

Potential Future Payments from Licensees

Beyond the upfront cash, the structure of the WY Biotech deal sets up future income potential based on performance. HCW Biologics Inc. is eligible for:

• Additional significant development milestone payments.
• Double-digit royalties on future product sales.
• A share of a substantial portion of proceeds from any future transaction(s) involving the licensed molecule.

Royalties on Future Commercial Product Sales

This stream is directly linked to the success of licensed molecules post-development. The agreement with WY Biotech explicitly includes eligibility for double-digit royalties on future product sales for HCW11-006.

Sale of Licensed Molecules

Revenue from the sale of licensed molecules, historically derived exclusively from Wugen, saw a sharp decline due to a strategic suspension. The Q3 2025 revenue figure was only $15,606. For context on the impact of the one-year suspension of the Wugen License Agreement:

Period Ended September 30,	Q3 Revenue	Nine-Month Revenue
2024	$426,423	$2.2 million
2025	$15,606	$27,222

To be fair, Q2 2025 revenue was also minimal at just $6,550.

Equity Financing Proceeds and Other Cash Inflows

Capital raises are a critical, non-operational revenue stream for a clinical-stage company like HCW Biologics Inc. The May 2025 offering provided immediate liquidity.

• Gross proceeds from the follow-on equity offering closed on May 15, 2025, totaled $5.0 million.
• In Q3 2025, the company raised an additional $2.2 million via the issuance of 475,000 shares under its Standby Equity Purchase Agreement.
• In January 2025, HCW Biologics Inc. received a $2.0 million insurance reimbursement.

Here's a quick look at the financing activity:

Financing Event	Date Closed	Gross Proceeds/Amount
Equity Offering	May 15, 2025	$5.0 million
Standby Equity Issuance (Q3)	Q3 2025	$2.2 million (from 475,000 shares)
Insurance Reimbursement	January 2025	$2.0 million

Also, on May 7, 2025, the company extinguished $7.7 million of debt through restructuring or conversion to equity.

Finance: draft 13-week cash view by Friday.