[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents the company's Q1 2025 financial statements, including balance sheets, statements of operations, changes in equity, and cash flows, along with management's discussion of the critical financial condition, operational results, liquidity challenges, and internal controls [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) For the quarter ended March 31, 2025, the company reported a significant decrease in revenue and a net loss of $2.2 million, an improvement from a $7.5 million loss in the prior-year period, primarily due to a large credit from legal expense reimbursements. The balance sheet reflects a deteriorating financial position, with cash reserves dwindling to $1.1 million and a growing stockholders' deficit of $8.6 million. The statements highlight significant liquidity challenges and a substantial doubt about the company's ability to continue as a going concern, which is further detailed in the notes [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) As of March 31, 2025, the company's total assets decreased to $26.3 million from $30.2 million at year-end 2024, driven by a significant drop in cash and cash equivalents from $4.7 million to $1.1 million. Total liabilities stood at $34.8 million, with current liabilities of $27.1 million exceeding total current assets of $1.9 million. The stockholders' deficit widened from $6.8 million to $8.6 million, indicating a worsening financial position Condensed Balance Sheet Summary (Unaudited) | Account | Dec 31, 2024 | Mar 31, 2025 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $4,674,572 | $1,107,613 | | Total current assets | $5,698,482 | $1,894,708 | | Total assets | $30,236,578 | $26,285,406 | | **Liabilities & Stockholders' Deficit** | | | | Total current liabilities | $29,628,885 | $27,142,090 | | Total liabilities | $37,006,750 | $34,847,454 | | Total stockholders' deficit | $(6,770,172) | $(8,562,048) | [Condensed Statements of Operations](index=5&type=section&id=Condensed%20Statements%20of%20Operations) For the three months ended March 31, 2025, revenues plummeted to $5,065 from $1.1 million in the prior-year period. The company reported a net loss of $2.2 million, a significant improvement from a $7.5 million net loss in Q1 2024. This improvement was primarily driven by a net credit in legal expenses of $1.7 million (due to a $2.0 million insurance reimbursement), which offset a $4.4 million expense in the prior year. Research and development expenses decreased, while general and administrative costs rose Condensed Statement of Operations (Unaudited, Three Months Ended March 31) | Metric | 2024 | 2025 | | :--- | :--- | :--- | | Revenues | $1,126,712 | $5,065 | | Net revenues | $614,747 | $1,013 | | Research and development | $2,123,284 | $1,478,711 | | General and administrative | $1,566,092 | $2,227,597 | | Legal expenses, net | $4,419,034 | $(1,739,493) | | Loss from operations | $(7,493,663) | $(1,965,802) | | Net loss | $(7,468,061) | $(2,196,875) | | Net loss per share, basic and diluted | $(0.20) | $(0.05) | [Condensed Statements of Changes in Stockholders' Equity (Deficit)](index=6&type=section&id=Condensed%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity%20%28Deficit%29) For the three months ended March 31, 2025, the total stockholders' deficit increased from $6.8 million to $8.6 million. The change was primarily driven by the net loss of $2.2 million for the period, slightly offset by stock-based compensation and minor proceeds from stock option exercises - The balance of stockholders' deficit increased from **$(6,770,172)** at the beginning of the quarter to **$(8,562,048)** at the end of the quarter, mainly due to the net loss of **$(2,196,875)**[17](index=17&type=chunk) [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) For the first quarter of 2025, net cash used in operating activities was $3.5 million, similar to the prior year. There were no investing activities. Financing activities resulted in a net cash use of $53,103, a stark contrast to the $4.2 million provided by financing in Q1 2024. Consequently, cash and cash equivalents decreased by $3.6 million during the quarter, ending at $1.1 million Cash Flow Summary (Unaudited, Three Months Ended March 31) | Activity | 2024 | 2025 | | :--- | :--- | :--- | | Net cash used in operating activities | $(3,603,870) | $(3,513,856) | | Net cash used in investing activities | $(129,709) | $0 | | Net cash provided by (used in) financing activities | $4,222,554 | $(53,103) | | **Net increase (decrease) in cash** | **$488,975** | **$(3,566,959)** | | **Cash and cash equivalents at end of period** | **$4,084,076** | **$1,107,613** | [Notes to Condensed Interim Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Interim%20Financial%20Statements) The notes disclose critical information, including a reverse stock split effective April 11, 2025, and a formal conclusion that substantial doubt exists about the company's ability to continue as a going concern due to sustained operating losses and negative working capital. Key events include legal disputes with its construction contractor BE&K, the settlement of arbitration with ImmunityBio, and various financing efforts to remain solvent and compliant with Nasdaq listing rules. Subsequent events after the quarter-end, such as a $5.0 million equity offering and the conversion of $6.6 million in secured notes, are crucial to the company's immediate future - Management concluded that there is **substantial doubt** about the Company's ability to continue as a going concern for at least 12 months from the issuance date of the financial statements[26](index=26&type=chunk)[41](index=41&type=chunk)[42](index=42&type=chunk) - A **1-for-40 reverse stock split** was effective on April 11, 2025[24](index=24&type=chunk) - The company is involved in legal proceedings with its general contractor, BE&K, which has filed a complaint and mechanics liens related to unpaid invoices for the construction of its new manufacturing facility[29](index=29&type=chunk)[90](index=90&type=chunk)[93](index=93&type=chunk) - Subsequent to quarter-end, the company closed a **$5.0 million equity offering**, converted **$6.6 million of secured notes to equity**, and gained access to a **$40.0 million equity line of credit (ELOC)** to improve its financial position and regain Nasdaq compliance[95](index=95&type=chunk)[98](index=98&type=chunk)[36](index=36&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's dire financial condition, highlighting the substantial doubt about its ability to continue as a going concern. The analysis focuses on the sharp decline in Q1 2025 revenue and the factors driving the reduced net loss, primarily a one-time insurance reimbursement for legal fees. The discussion details the company's strategy to survive, which hinges on a new financing plan launched after settling a major arbitration. This plan includes an equity line of credit, a potential $7.0 million license fee from WY Biotech, and recent equity offerings. The company is also actively working to regain compliance with all Nasdaq listing requirements to maintain its public listing [Overview](index=28&type=section&id=Overview) The company is a clinical-stage biopharmaceutical firm focused on developing immunotherapies for diseases linked to chronic inflammation and aging, a condition known as "inflammaging." It utilizes two proprietary platforms, TOBI™ and TRBC, to create its drug candidates. Following a settlement with ImmunityBio, the company has reassessed its pipeline to focus on protein-based immunotherapies for life-threatening diseases like pancreatic cancer and quality-of-life conditions such as alopecia areata - The company focuses on developing immunotherapies for diseases promoted by chronic inflammation, particularly age-related **"inflammaging"**[102](index=102&type=chunk) - The company utilizes two drug discovery platforms: the legacy **TOBI™ platform** and the new **TRBC platform** for creating multi-specific cytokines and immune-cell engagers[105](index=105&type=chunk)[108](index=108&type=chunk) - Following a legal settlement, the company has clarified its intellectual property and is focusing its clinical development on select product candidates like HCW9302, while seeking partners for non-core assets[106](index=106&type=chunk)[107](index=107&type=chunk) [Business Highlights and Clinical Development](index=30&type=section&id=Business%20Highlights%20and%20Clinical%20Development) Key business developments include amending the WY Biotech license agreement, which could yield a $7.0 million fee in June 2025, and closing a $5.0 million equity offering in May 2025. However, the project to build a manufacturing facility is stalled due to legal action from the contractor over unpaid invoices. The company is focused on regaining Nasdaq compliance, having achieved the minimum bid price requirement and making progress on other rules. Clinically, the FDA cleared an IND for a Phase 1 trial of HCW9302 for alopecia areata, expected to start in Q3 2025. The company is also seeking commercial partners for its HCW9206 compound for CAR-T therapies - The company expects to receive a **$7.0 million license fee** from WY Biotech in June 2025, pending WY Biotech's acceptance of a technology transfer report[111](index=111&type=chunk)[119](index=119&type=chunk) - Closed a **$5.0 million equity offering** on May 15, 2025, and restructured existing warrants to a lower exercise price[113](index=113&type=chunk) - The company regained compliance with the Nasdaq minimum bid price rule and is working to meet other listing requirements by a June 16, 2025 deadline[117](index=117&type=chunk)[120](index=120&type=chunk) - Received FDA clearance to initiate a **Phase 1 clinical trial for HCW9302** in patients with alopecia areata, with the study expected to begin in Q3 2025[124](index=124&type=chunk)[125](index=125&type=chunk) [Results of Operations](index=38&type=section&id=Results%20of%20Operations) Comparing Q1 2025 to Q1 2024, revenues fell drastically from $1.1 million to just $5,065. Research and development expenses decreased by 30% to $1.5 million, mainly due to reduced manufacturing and preclinical activities. General and administrative expenses rose 42% to $2.2 million, driven by accretion expense on secured notes and increased professional fees. Legal expenses showed a net credit of $1.7 million due to an insurance reimbursement, compared to a $4.4 million expense in the prior year, which was the primary reason for the smaller net loss of $2.2 million Comparison of Operating Results (Three Months Ended March 31) | Metric | 2024 | 2025 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Net revenues | $614,747 | $1,013 | $(613,734) | (99.8)% | | Research and development | $2,123,284 | $1,478,711 | $(644,573) | (30)% | | General and administrative | $1,566,092 | $2,227,597 | $661,505 | 42% | | Legal expenses, net | $4,419,034 | $(1,739,493) | $(6,158,527) | N/A | | **Net loss** | **$(7,468,061)** | **$(2,196,875)** | **$5,271,186** | **(70.6)%** | - The decrease in R&D expenses was primarily due to a **$313,503 (54%) decline** in manufacturing and materials costs and a **$107,980 (38%) decline** in preclinical expenses as certain studies were completed[152](index=152&type=chunk)[154](index=154&type=chunk)[155](index=155&type=chunk) - The increase in G&A expenses was mainly due to a **$273,059 accretion expense** for the Secured Notes' bonus payment and a **$100,563 increase** in professional services fees[158](index=158&type=chunk)[160](index=160&type=chunk)[162](index=162&type=chunk) [Liquidity and Capital Resources](index=44&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity is critically low, with only $1.1 million in cash as of March 31, 2025, leading to substantial doubt about its ability to operate for the next twelve months. Operations are funded through stock sales, debt, and license revenues. The company faces significant liabilities, including $12.4 million in unpaid legal fees and potential acceleration of its $6.5 million bank loan due to construction-related liens. To address this, the company has secured access to a $40 million equity line of credit, raised $5.0 million in a May 2025 offering, converted $6.6 million of debt to equity, and anticipates a $7.0 million license fee. Despite these efforts, management concluded the substantial doubt was not alleviated - As of March 31, 2025, the company had **$1.1 million in cash and cash equivalents**, and management concluded there was **substantial doubt** about its ability to continue as a going concern[170](index=170&type=chunk)[185](index=185&type=chunk) - The company has significant outstanding liabilities, including **$12.4 million in unpaid legal fees** from a past arbitration and is facing lawsuits from its general contractor (BE&K) over unpaid construction invoices[174](index=174&type=chunk)[172](index=172&type=chunk) - Key financing activities to improve liquidity include a **$40M Equity Purchase Agreement (ELOC)**, a potential **$7.0M license fee** from WY Biotech, a **$5.0M equity offering** (May 2025), and the conversion of **$6.6M in Secured Notes to equity** (May 2025)[178](index=178&type=chunk)[177](index=177&type=chunk)[182](index=182&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=50&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk exposures are interest rate sensitivity on its cash and cash equivalents and the marketability risk of its investment in Wugen common stock, which is a private company with limited liquidity - Primary market risk is **interest rate sensitivity**. The company is also exposed to **marketability risk** for its Wugen common stock investment, as there is no public market for these shares[201](index=201&type=chunk) [Controls and Procedures](index=50&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures as of March 31, 2025, and concluded that they were effective. There were no material changes in internal control over financial reporting during the quarter - Based on an evaluation as of March 31, 2025, the CEO and CFO concluded that the company's **disclosure controls and procedures were effective**[203](index=203&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[206](index=206&type=chunk) [PART II. OTHER INFORMATION](index=53&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section details recent legal proceedings, confirms no material changes to risk factors, outlines unregistered equity sales, and provides further information on the Senior Secured Note financing and its conversion to equity [Legal Proceedings](index=53&type=section&id=Item%201.%20Legal%20Proceedings) The company has resolved its major arbitration with ImmunityBio through a settlement agreement that clarified intellectual property rights, with no monetary payments required by either party. However, the company is now facing new legal challenges. On April 17, 2025, its general contractor, BE&K, filed a complaint related to unpaid invoices for the construction of its manufacturing facility, and other subcontractors have also filed claims - The company entered into a confidential settlement agreement with ImmunityBio on July 13, 2024, resolving a major arbitration. The settlement involved transferring ownership of certain TOBI-based molecule IP to ImmunityBio while retaining key rights to lead product candidates like HCW9218 (for non-cancer diseases), HCW9302, and HCW9206[210](index=210&type=chunk)[211](index=211&type=chunk) - On April 17, 2025, the company received a complaint filed by its general contractor, BE&K Building Group, related to the construction of its new facility. Other subcontractors have also filed counterclaims and cross-claims[213](index=213&type=chunk) [Risk Factors](index=54&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K - No material changes to the risk factors disclosed in the Annual Report have occurred[214](index=214&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=54&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details several sales of unregistered securities. In February 2024, the company sold $2.5 million of common stock to officers and directors. In November 2024, it issued unregistered warrants to purchase 6,717,000 shares of common stock in a private placement. In March 2025, it issued 384,615 shares as a commitment fee for an Equity Purchase Agreement - In February 2024, the company sold **1,785,718 unregistered shares of common stock** to certain officers and directors for aggregate proceeds of **$2.5 million**[215](index=215&type=chunk) - In November 2024, as part of a larger offering, the company issued unregistered warrants to purchase up to **6,717,000 shares of common stock** in a private placement[217](index=217&type=chunk) - On March 12, 2025, the company issued **384,615 unregistered shares of common stock** as a commitment fee for its Equity Purchase Agreement with Square Gate Capital[219](index=219&type=chunk) [Other Information](index=55&type=section&id=Item%205.%20Other%20Information) This section provides detailed information on the Senior Secured Note financing, which raised an aggregate of $6.9 million by October 2024. The notes are secured by the company's equity in Wugen, Inc. A significant development was the subsequent agreement to convert $6.6 million of this debt into equity. This conversion, approved by stockholders on March 31, 2025, and effected on May 7, 2025, was a key part of the company's plan to improve its stockholders' equity and regain compliance with Nasdaq listing rules - The company issued an aggregate of **$6.9 million in Senior Secured Notes** between March and October 2024, which are secured by the company's equity ownership in Wugen, Inc[225](index=225&type=chunk)[226](index=226&type=chunk)[228](index=228&type=chunk) - On March 31, 2025, stockholders approved the conversion of at least **$6.6 million of the Secured Notes** into common stock and warrants[233](index=233&type=chunk) - The conversion was completed on May 7, 2025, which cancelled the notes and resulted in the issuance of unregistered common stock and warrants to the participating noteholders[234](index=234&type=chunk) [Exhibits](index=60&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report, including agreements related to the Equity Purchase Agreement, various promissory notes, placement agency agreements, and officer certifications

[Overview and Business Highlights](index=1&type=section&id=HCW%20Biologics%20Reports%20First%20Quarter%202025%20Business%20Highlights%20and%20Financial%20Results) This section covers the CEO's strategic financing and business development initiatives, recent equity offerings, and progress in regaining Nasdaq compliance [CEO Statement and Financing Strategy](index=1&type=section&id=CEO%20Statement%20and%20Financing%20Strategy) The CEO announced a $5.0 million equity offering to fund the HCW9302 Phase 1 trial and is intensifying business development for TRBC platform licensing, including HCW9206 - Closed a **$5.0 million** equity offering on May 15, 2025, with a single institutional investor in a difficult market[3](index=3&type=chunk) - The funding will support the initiation of a Phase 1 clinical trial for HCW9302 in an autoimmune disorder and advance the business development campaign for licensing Immune-Cell Engagers[3](index=3&type=chunk) - The company plans to increase business development efforts in the second half of 2025, focusing on licensing its portfolio of over 50 compounds, with HCW9206 being a key candidate for commercialization to improve CAR-T manufacturing[3](index=3&type=chunk) [Business Development Transactions](index=1&type=section&id=Business%20Development%20Transactions) HCW Biologics delivered its technology report for the HCW11-006 license to WY Biotech, anticipating a $7.0 million upfront fee after due diligence - On May 13, 2025, the Company provided its technology report to WY Biotech for the exclusive worldwide license of HCW11-006, a preclinical drug from the TRBC platform[4](index=4&type=chunk) - The Company expects to recognize revenue for a **$7.0 million** upfront licensing fee after WY Biotech completes its 30-day due diligence[4](index=4&type=chunk) [Financing Transactions](index=1&type=section&id=Financing%20Transactions) The company completed a $5.0 million equity offering and regained partial Nasdaq compliance, with full compliance required by June 16, 2025 - On May 15, 2025, the company completed a **$5.0 million** offering of **671,140 units** at a price of **$7.45 per unit**[5](index=5&type=chunk) - The exercise price of certain existing warrants to purchase up to **167,925 shares** was reduced from **$41.20 to $7.45 per share**[6](index=6&type=chunk) - On May 13, 2025, the company regained compliance with Nasdaq's bid price, public float, and market value of publicly held shares requirements, with a deadline of June 16, 2025, to comply with all remaining Listing Rules[6](index=6&type=chunk) [Clinical Development Results](index=2&type=section&id=Clinical%20Development%20Results) FDA cleared HCW9302 Phase 1 trial for alopecia areata, expected Q3 2025, while HCW9206 commercialization targets CAR-T manufacturing improvement - Received FDA clearance on January 28, 2025, for its IND to start a first-in-human Phase 1 trial of HCW9302 in patients with moderate-to-severe alopecia areata[9](index=9&type=chunk) - The multi-site, company-sponsored trial for HCW9302 is expected to be initiated in the third quarter of 2025[9](index=9&type=chunk) - The company is commercializing its clinical-stage molecule, HCW9206, which has shown potential to generate CAR-T cells with a stem cell-like memory phenotype, enhancing persistence and lowering manufacturing costs[9](index=9&type=chunk) [First Quarter 2025 Financial Results](index=2&type=section&id=First%20Quarter%202025%20Financial%20Results) Q1 2025 net loss improved to $2.2 million from $7.5 million in Q1 2024, driven by reduced net legal expenses despite lower revenues and increased G&A Q1 2025 vs Q1 2024 Financial Highlights | Financial Metric | Q1 2025 ($) | Q1 2024 ($) | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Revenues | $5,065 | $1,126,712 | -$1,121,647 | -99.5% | | R&D Expenses | $1.5 million | $2.1 million | -$0.6 million | -30% | | G&A Expenses | $2.2 million | $1.6 million | +$0.6 million | +42% | | Legal Expenses, net | ($1.7 million) | $4.4 million | -$6.1 million | N/A | | Net Loss | $2.2 million | $7.5 million | -$5.3 million | -70.7% | - The decrease in R&D expenses by **30%** was mainly due to a decline in manufacturing, material, and preclinical expenses[9](index=9&type=chunk) - The **42%** increase in G&A expenses was primarily due to the absence of officer bonus waivers that occurred in Q1 2024 and accretion of a fixed bonus related to Secured Notes[9](index=9&type=chunk) - Net legal expenses were negative (**$1.7 million**) in Q1 2025 due to a **$2.0 million** insurance reimbursement, compared to **$4.4 million** in legal fees incurred in Q1 2024 for an arbitration case[13](index=13&type=chunk) [Financial Guidance](index=3&type=section&id=Financial%20Guidance) As of March 31, 2025, HCW Biologics concluded substantial doubt exists about its going concern ability for the next 12 months, necessitating additional funding - As of March 31, 2025, the Company concluded that substantial doubt exists regarding its ability to continue as a going concern for at least 12 months from the financial statement issuance date[11](index=11&type=chunk) - The company requires additional funding or financial support, as its current financing plan is not assured to be fully successful in mitigating the going concern risk[11](index=11&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) This section presents the unaudited statements of operations and condensed balance sheets for Q1 2025, detailing the company's financial performance and position [Unaudited Statements of Operations](index=5&type=section&id=Unaudited%20Statements%20of%20Operations) Q1 2025 net loss was $2.2 million ($0.05 per share), a significant improvement from Q1 2024's $7.5 million loss, primarily due to decreased net legal expenses Unaudited Statements of Operations (For the Three Months Ended March 31) | | 2024 ($) | 2025 ($) | | :--- | :--- | :--- | | **Revenues** | **$1,126,712** | **$5,065** | | Cost of revenues | ($511,965) | ($4,052) | | **Net revenues** | **$614,747** | **$1,013** | | Research and development | $2,123,284 | $1,478,711 | | General and administrative | $1,566,092 | $2,227,597 | | Legal expenses, net | $4,419,034 | ($1,739,493) | | **Total operating expenses** | **$8,108,410** | **$1,966,815** | | **Loss from operations** | **($7,493,663)** | **($1,965,802)** | | Interest expense | — | ($255,822) | | Other income, net | $25,602 | $24,749 | | **Net loss** | **($7,468,061)** | **($2,196,875)** | | Net loss per share, basic and diluted | ($0.20) | ($0.05) | | Weighted average shares outstanding | 37,223,588 | 44,675,656 | [Condensed Balance Sheets](index=6&type=section&id=Condensed%20Balance%20Sheets) As of March 31, 2025, total assets were $26.3 million, liabilities $34.8 million, and stockholders' deficit $8.6 million, with cash decreasing to $1.1 million Condensed Balance Sheet Highlights | | Dec 31, 2024 ($) | Mar 31, 2025 (Unaudited) ($) | | :--- | :--- | :--- | | **ASSETS** | | | | Cash and cash equivalents | $4,674,572 | $1,107,613 | | Total current assets | $5,698,482 | $1,894,708 | | **Total assets** | **$30,236,578** | **$26,285,406** | | **LIABILITIES AND STOCKHOLDERS' DEFICIT** | | | | Total current liabilities | $29,628,885 | $27,142,090 | | **Total liabilities** | **$37,006,750** | **$34,847,454** | | **Total stockholders' deficit** | **($6,770,172)** | **($8,562,048)** | [About HCW Biologics](index=3&type=section&id=About%20HCW%20Biologics) HCW Biologics is a clinical-stage biopharmaceutical company developing immunotherapies for chronic inflammation-driven diseases using its TOBI™ and TRBC platforms - HCW Biologics is a clinical-stage biopharmaceutical company developing immunotherapies for diseases promoted by chronic inflammation, including cancer, autoimmune diseases, and neurodegenerative diseases[12](index=12&type=chunk) - The company's lead product candidate, HCW9302, was developed using its legacy TOBI™ platform[12](index=12&type=chunk) - A second drug discovery platform, TRBC, has been used to construct over **50 molecules** and can create multiple classes of immunotherapeutics, including Immune Cell Stimulators, Checkpoint Inhibitors, and Multi-Specific Targeting Fusions[12](index=12&type=chunk) [Forward Looking Statements](index=4&type=section&id=Forward%20Looking%20Statements) This section outlines forward-looking statements subject to significant risks and uncertainties, including going concern status, future capital, and clinical trial success - The press release contains forward-looking statements made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995[14](index=14&type=chunk) - These statements are subject to inherent uncertainties and risks, and are based on assumptions that may not prove accurate[14](index=14&type=chunk) - Key risks include the company's ability to continue as a going concern, its cash runway, ability to license its molecules, initiation of clinical trials, and future capital-raising plans[14](index=14&type=chunk)

Core Viewpoint - HCW Biologics Inc. has announced a follow-on offering of 671,140 units at a price of $7.45 per unit, aiming to raise approximately $5.0 million for various developmental and corporate purposes [1][3]. Group 1: Offering Details - The offering consists of units that include one share of common stock (or pre-funded warrant) and two warrants, each with an exercise price of $7.45, exercisable immediately and expiring five years from the issuance date [1]. - The closing of the offering is expected around May 15, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be allocated to funding preclinical and clinical development, including trials for HCW9302, business development, out-licensing, collaborations, patent portfolio expansion, research and development, and general corporate purposes [3]. Group 3: Existing Warrants Adjustment - The company has negotiated to reduce the exercise price of certain existing warrants from $41.20 to $7.45 per share [4]. Group 4: Company Overview - HCW Biologics Inc. is focused on developing novel immunotherapies targeting chronic inflammation and age-related diseases, with a lead product candidate, HCW9302, developed using the TOBI™ platform [7]. - The company has also created the TRBC platform for constructing immunotherapeutics that target immune responses and cancerous cells, with over 50 molecules developed [7][8].

Core Insights - HCW Biologics Inc. has presented studies indicating that its proprietary fusion protein HCW9206 offers a new pathway for generating CAR-T cells with enhanced function and reduced manufacturing costs [2][3] - The research shows that HCW9206 outperforms standard CAR-T production methods, leading to improved persistence and efficacy of CAR-T cells in treating various diseases [2][3] Company Overview - HCW Biologics is a clinical-stage biopharmaceutical company focused on developing innovative immunotherapies targeting chronic inflammation and related diseases [4][5] - The company has established a GMP master cell bank for HCW9206 and filed a drug master file with the FDA, indicating readiness for commercial partnerships [3][4] Product Development - HCW9206 is designed to deliver synergistic signals from three immune-stimulatory cytokines, enhancing the production of stem cell-like memory T cells (Tscm) which are crucial for effective CAR-T therapies [2][3] - The company has developed additional drug discovery technologies, including the TRBC platform, which allows for the creation of various immunotherapeutic compounds targeting cancer and autoimmune diseases [5]

Core Points - HCW Biologics Inc. announced a 1-for-40 reverse stock split effective April 11, 2025, to comply with Nasdaq's minimum bid price requirement of $1.00 per share [1][2] - The reverse stock split will reduce the number of shares outstanding from approximately 44,934,120 to about 1,123,353, while the total authorized shares will remain at 250,000,000 [3] - The reverse stock split will not affect stockholders' percentage ownership, except for those who would receive fractional shares, who will instead receive one whole share [2][3] Company Overview - HCW Biologics is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies aimed at extending health span by addressing inflammation linked to age-related diseases [6] - The company utilizes two drug discovery platforms: the TOBI™ platform, which has produced several molecules including HCW9218 and HCW9302, and the TRBC platform, which employs a unique protein-based backbone for immunotherapeutics [6]

Drug Development and Clinical Trials - HCW Biologics Inc. is developing proprietary immunotherapies targeting chronic inflammation and age-related diseases, aiming to improve quality of life and potentially extend longevity[16]. - The company has two drug discovery platforms: the TOBI™ platform for multi-functional fusion proteins and the TRBC platform for novel immunotherapeutics[19][20]. - HCW9302, a first-in-kind IL-2 fusion protein, has received FDA clearance to initiate a Phase 1 clinical study for alopecia areata, with plans to expand to other indications[23]. - HCW9218, a bifunctional immunotherapeutic, is designed to reduce senescent cells and their proinflammatory factors, with clinical studies planned pending a supply agreement with ImmunityBio[27][30]. - The company has constructed over 50 compounds using the TRBC platform, focusing on selecting lead compounds for further development[34]. - The company aims to develop second-generation immune checkpoint inhibitors and multi-specific targeting fusions, with a focus on collaborations with larger pharmaceutical companies for Class III molecules[36]. - The Phase 1 trial for HCW9302 is a significant milestone, with potential expansion into other autoimmune diseases and serious inflammatory conditions if successful[50]. - The Company received FDA clearance for a Phase 1 clinical trial of HCW9302 in patients with moderate-to-severe alopecia areata, with the lead site expected to open in late Q2 or early Q3 2025[66]. - The Company plans to seek a partner for the development of T-Cell Engager and other Immune Cell Engagers in Q2 2025[66]. - The Company intends to refine potential expanded indications for Phase 2 clinical studies during Phase 1, focusing on autoimmune diseases and inflammatory conditions[66]. - The Company anticipates completing efficacy assessments in mice and safety profiling in non-human primates for HCW11-006 by the end of 2025[98]. - The Company has completed cGMP production of five molecules as of December 31, 2024, sufficient for planned Phase 1/2 clinical trials in 2025 and 2026[113]. - The Company purchased a 36,000 square foot building in Florida for cGMP clinical drug manufacturing, with validation expected in the first half of 2026[115]. Market and Competitive Landscape - The global population aged 60 years and older was estimated at 1.4 billion in 2020, expected to double to 2.1 billion by 2050, highlighting the growing need for treatments addressing age-related diseases[58]. - The company faces competition from major pharmaceutical and biotechnology companies, academic institutions, and research organizations, emphasizing the need for a strong competitive strategy[147]. - The company faces significant competition from larger pharmaceutical and biotechnology firms with greater financial resources and expertise in R&D, manufacturing, and clinical trials[148]. - The market for immune checkpoint inhibitors is dominated by Merck & Co. and Bristol Myers Squibb, with key products like Pembrolizumab (Keytruda®) and Nivolumab (Opdivo) facing patent expirations in 2028[157]. - The company recognizes the risk of competitors developing safer and more effective products that could capture market share before its own products are approved[155]. - There is a growing interest in targeting aging-related diseases, with major pharmaceutical companies investing heavily in this area due to its enormous market potential[151]. - The company is competing in the oncology segment against established players like Amgen and Pfizer, focusing on innovative therapies[150]. Intellectual Property and Licensing - As of December 31, 2024, the Company holds ten issued U.S. patents and 124 pending patent applications worldwide[120]. - The Company has created over 50 immunotherapeutic molecules and expects out-licensing to provide non-dilutive financing for core markets and programs[107]. - The Company entered into a license agreement with Wugen for two fusion protein molecules, retaining manufacturing rights and receiving milestone payments and royalties[108][109]. - The exclusive worldwide license agreement with Wugen grants rights to develop, manufacture, and commercialize cellular therapy products, with HCW Biologics retaining a 5.6% ownership interest in Wugen as of December 31, 2024[140]. - The WY Biotech License Agreement includes milestone payments as the licensed molecule advances through clinical trials, with double-digit royalties upon commercialization[145]. - The company has established expertise in preclinical research, manufacturing, quality control, regulatory affairs, and clinical trial design, which supports its product development efforts[138]. Regulatory Environment - The FDA requires a Biologics License Application (BLA) to include results from all preclinical and clinical testing, along with data on pharmacology, chemistry, and manufacturing[168]. - Most BLAs are classified as Standard Review, which typically takes ten months, while Priority Review applications are reviewed within six months[170]. - The FDA may require a risk evaluation and mitigation strategy (REMS) as a condition of BLA approval to ensure the benefits outweigh potential risks[171]. - Accelerated approval may be granted for products that provide a meaningful therapeutic advantage, based on surrogate endpoints or earlier clinical endpoints[179]. - The FDA's Food and Drug Omnibus Reform Act (FDORA) allows for post-approval studies to be required prior to or shortly after approval, with progress reports due every 180 days[180]. - Adverse event reporting and periodic reports are mandatory after BLA approval, with the FDA able to impose post-marketing testing and surveillance[187]. - Manufacturers must maintain compliance with current Good Manufacturing Practices (cGMP) after approval, subject to periodic inspections by the FDA[187]. - The FDA has the authority to withdraw product approvals if regulatory standards are not met or if new safety issues arise post-marketing[186]. Financial and Market Access Challenges - Coverage and reimbursement for pharmaceutical products depend on third-party payors, with no uniform policy existing in the U.S.[204]. - Obtaining coverage and adequate reimbursement for products administered under physician supervision may be particularly challenging due to higher prices[205]. - The U.S. government and foreign governments are implementing cost-containment programs, including price controls and restrictions on coverage[206]. - The Inflation Reduction Act (IRA) allows HHS to negotiate prices for 10 high-cost Medicare Part D products starting in 2026, with 15 additional drugs selected for negotiation in 2027[207]. - The IRA imposes rebates on Medicare Part B and Part D drugs whose prices increase faster than inflation, with finalized regulations announced in November 2024[207]. Research and Development Focus - The company is involved in the development of treatments for bronchopulmonary dysplasia (BPD), addressing unmet needs in premature infants[156]. - The complexity of clinical development for Class III TRBC Molecules is more suited for well-capitalized pharmaceutical companies, presenting challenges for smaller firms[105]. - The company is exploring the potential of HCW9302 in targeting neurodegenerative diseases, with ongoing collaborations to understand its biology[153]. - The methods of promoting NK cell activation and proliferation are covered by U.S. Patent Nos. 11,730,762 and 11,738,052, along with 16 pending patent applications across various jurisdictions[128].

Financial Performance - Revenues for Q4 2024 were $394,804, a decrease of 70.5% compared to $1.3 million in Q4 2023; total revenues for the fiscal year 2024 were $2.6 million, down from $2.8 million in 2023[11] - Net loss for Q4 2024 was $3.4 million, compared to a net loss of $10.7 million in Q4 2023; total net loss for 2024 was $30.0 million, up from $25.0 million in 2023[11] - Revenues for the three months ended December 31, 2023, were $1,324,003, compared to $394,804 for the same period in 2024, representing a significant increase[18] - Net loss for the three months ended December 31, 2023, was $(10,680,530), compared to $(3,373,273) for the same period in 2024, indicating a worsening financial position[18] - Total operating expenses for the three months ended December 31, 2023, were $11,020,836, up from $3,238,720 in 2024, reflecting increased costs[18] - The accumulated deficit as of December 31, 2023, was $(70,532,323), which increased to $(100,556,137) in 2024, highlighting ongoing financial challenges[20] - The company reported a net loss per share of $(0.30) for the three months ended December 31, 2023, compared to $(0.08) for the same period in 2024[18] - Weighted average shares outstanding increased from 35,996,415 in 2023 to 42,301,694 in 2024, reflecting potential dilution of shares[18] Research and Development - R&D expenses for Q4 2024 were $1.0 million, a decrease of 51% from $2.1 million in Q4 2023; total R&D expenses for 2024 were $6.4 million, down 17% from $7.7 million in 2023[11] - Research and development expenses for the year ended December 31, 2023, were $7,676,316, compared to $6,388,994 in 2024, showing a year-over-year increase[18] - The company constructed 50 proprietary compounds using the TRBC platform for treating hematologic and solid tumors, virally infected cells, and age-related diseases[3] - The company is focusing on developing Immune-Cell Engagers, including T-Cell Engagers, through corporate partnerships and out-licensing arrangements[6] - The company received clearance from the FDA to initiate a Phase 1 clinical trial for HCW9302 in patients with moderate-to-severe alopecia areata[9] Financial Position and Funding - The company raised $16.3 million in 2024 through various financing transactions, including a $6.9 million securities purchase agreement with an institutional investor[6] - The company expects to receive $7.0 million from WY Biotech in June 2025 under an exclusive licensing agreement for the preclinical drug HCW11-006[6] - Legal expenses for 2024 increased by 142% to $15.9 million, primarily due to costs associated with arbitration proceedings[11] - The company has substantial doubt regarding its ability to continue as a going concern for at least 12 months without additional funding[12] Assets and Liabilities - Cash and cash equivalents as of December 31, 2023, were $3,595,101, compared to $4,674,572 in 2024, indicating a decrease in liquidity[20] - Total assets as of December 31, 2023, were $28,513,660, compared to $30,236,578 in 2024, showing a growth in total assets[20] - Total liabilities increased significantly from $15,051,943 in 2023 to $37,006,750 in 2024, indicating a rise in financial obligations[20]

Core Insights - HCW Biologics Inc. is focused on developing novel immunotherapies to address age-related diseases and has reported its financial results for the fourth quarter and fiscal year ended December 31, 2024 [1] Business Highlights - The company has received clearance to begin clinical trials for HCW9302, targeting alopecia areata, and has developed a new drug discovery platform utilizing T-cell Receptor β Chain constant region (TRBC) [2] - HCW Biologics has constructed 50 proprietary compounds using the TRBC platform aimed at treating various cancers and age-related diseases [2] - The company entered an exclusive licensing agreement with WY Biotech, expecting to receive $7 million in June 2025, and has opt-in rights for the Americas market after a Phase 1 clinical trial [5] Financial Results - Revenues for Q4 2024 were $394,000, down from $1.3 million in Q4 2023, while total revenues for the year decreased from $2.8 million in 2023 to $2.6 million in 2024 [9] - Research and development expenses decreased by 51% in Q4 2024 to $1 million, and for the year, R&D expenses fell by 17% to $6.4 million [9] - General and administrative expenses increased by 22% in Q4 2024 to $2 million, while remaining stable at $6.8 million for the year [9][10] Legal and Compliance - The company faced three deficiency notices from Nasdaq regarding stock price and market value but received an extension to regain compliance [9] - A special meeting of stockholders is scheduled for March 31, 2025, to approve critical proposals for compliance, including a reverse stock split [9] Future Outlook - The company has launched a multi-step financing plan and plans additional capital-raising activities in the first half of 2025 [11] - There is substantial doubt regarding the company's ability to continue as a going concern without additional funding [11]

Core Viewpoint - HCW Biologics Inc. has received an extension from the Nasdaq Hearings Panel to regain compliance with listing rules, allowing the company to continue its operations on the Nasdaq Capital Market [1][2]. Company Overview - HCW Biologics is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies aimed at extending healthspan by addressing inflammation-related age diseases [1][3]. - The company’s lead product candidate, HCW9302, is developed using the TOBI™ platform, while another drug discovery technology, the TRBC platform, allows for the creation of various immunotherapeutic compounds [3]. Compliance and Listing Status - The Nasdaq Panel granted the company an extension to demonstrate compliance with the Bid Price Rule by April 25, 2025, and all other continued listing rules by June 15, 2025 [2]. - The extension follows a hearing where the company's compliance plan was evaluated [2]. Product Development and Pipeline - HCW Biologics is developing immunotherapeutics that target chronic inflammation, with applications in oncology and other diseases associated with aging [3]. - The TRBC platform has enabled the creation of over 50 molecules, with ongoing preclinical evaluations for several promising candidates [3].

Core Viewpoint - HCW Biologics Inc. has received FDA clearance to initiate a first-in-human Phase 1 clinical trial for its lead drug candidate HCW9302, aimed at treating moderate-to-severe alopecia areata, an autoimmune disease with no current FDA-approved cure [1][3]. Company Overview - HCW Biologics Inc. is a clinical-stage biopharmaceutical company focused on developing innovative immunotherapies targeting chronic inflammation and related diseases, with a goal to improve healthspan and quality of life [5][6]. - The company's lead product candidate, HCW9302, is developed using the proprietary TOBI platform and is designed to activate and expand regulatory T cells to reduce inflammation without broad immunosuppression [1][5]. Drug Candidate Details - HCW9302 is an injectable interleukin 2 fusion protein complex that targets IL-2αβγ receptors on regulatory T cells, promoting their activation and expansion [1][2]. - Preclinical studies have shown that HCW9302 can effectively treat autoimmune diseases at well-tolerated doses through subcutaneous injections [2]. Clinical Trial Information - The Phase 1 trial aims to establish a safe dosage of HCW9302 that effectively increases Treg cell activity in patients with alopecia areata [3]. - Following the initial trial, the company plans to expand clinical development into Phase 2 studies for other autoimmune diseases and inflammatory conditions [3]. Alopecia Areata Overview - Alopecia areata affects approximately 1 in 1,000 people globally, with a lifetime incidence of 2%, translating to around 160 million individuals [4]. - The condition primarily impacts individuals under 30 and is characterized by sudden hair loss due to the immune system attacking hair follicles [4]. Future Development Plans - The company is exploring the potential of HCW9302 in treating other conditions associated with chronic inflammation, including dermatological issues, graft rejection, arthrosclerosis, diabetes, and neurodegenerative diseases [3][5].