HCW Biologics(HCWB) - 2025 Q2 - Quarterly Results

Company Overview & Recent Developments HCW Biologics Inc. is a clinical-stage biopharmaceutical company focused on novel immunotherapies, recently completing a $5 million equity offering and regaining Nasdaq compliance Introduction and Mission HCW Biologics Inc. is a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies aimed at extending healthspan by blocking the link between inflammation and age-related diseases - HCW Biologics Inc. (NASDAQ: HCWB) is a clinical-stage biopharmaceutical company dedicated to developing novel immunotherapies to extend healthspan by addressing the link between inflammation and age-related diseases[2] Key Corporate Updates The company completed a $5 million equity offering in May 2025 and successfully regained compliance with all Nasdaq listing requirements, ensuring continued listing eligibility - On May 15, 2025, the company completed a $5 million equity offering, with proceeds allocated to opening clinical sites for the Phase 1 clinical trial of HCW9302 for autoimmune diseases[3] - On June 24, 2025, the company received formal notification from Nasdaq confirming compliance with all Nasdaq Capital Market continued listing requirements, including share price, public float, and market value of publicly held shares[3] Business Highlights The company extended a $7 million license payment, paused a Wugen agreement, secured $5 million in equity, and plans to initiate a Phase 1 clinical trial for HCW9302 Business Development Transactions The $7 million license fee payment date with WY Biotech was extended to September 30, 2025. The licensing agreement with Wugen was paused for one year, and the company is actively seeking new licensing partners for HCW9206 and commercial partners for T-cell engager compounds - WY Biotech formally accepted the technical report and agreed to extend the $7 million license fee payment date to September 30, 2025[4] - After generating over $16 million in revenue from the Wugen licensing agreement, the company agreed to pause the agreement for one year, during which it will seek alternative licensing programs for HCW9206 and is in discussions with several biologics manufacturing companies for licensing as a reagent for CAR-T product manufacturing[4] - The company has initiated efforts to find strong commercial partners for its T-cell engager compounds, which are designed to target cancer antigens and CD3-activating effector T cells while reducing immunosuppression in the tumor microenvironment[4] Financing Activities The company completed a $5 million equity offering in May 2025 and eliminated $6.9 million in debt through restructuring or equity conversion in the same month, significantly improving its balance sheet - On May 15, 2025, the company completed a $5 million equity offering at $7.45 per unit, issuing 671,140 units to a single institutional investor, with each unit comprising two common stock warrants exercisable at $7.45[3][9] - On May 7, 2025, the company eliminated $6.9 million in debt through restructuring or conversion to equity, thereby strengthening its balance sheet and completing a significant part of its Nasdaq listing rule compliance plan[9] Clinical Development and Preclinical Results The company plans to initiate a Phase 1 clinical trial for HCW9302 in patients with alopecia areata in Q3 2025. Additionally, it developed second-generation T-cell engagers and immune checkpoint inhibitors using its TRBC platform, with a pembrolizumab-based fusion molecule showing strong anti-pancreatic cancer activity in preclinical studies - The company is on track to initiate a Phase 1 first-in-human dose-escalation clinical trial for HCW9302 in patients with alopecia areata in Q3 2025[9] - The company utilized its novel TRBC platform to develop second-generation T-cell engagers and second-generation immune checkpoint inhibitors, with T-cell engager compounds targeting tissue factor and a pembrolizumab-based fusion molecule of the immune checkpoint inhibitor showing strong anti-pancreatic cancer activity in preclinical studies[9] Second Quarter 2025 Financial Results Second quarter 2025 financial results show a significant revenue decline due to a paused licensing agreement, alongside reduced R&D and legal expenses Revenues Second quarter 2025 revenue significantly decreased to $6,550 from $618,854 in the prior-year period, primarily due to the paused licensing agreement with Wugen Revenue and Net Income | 指标 | 2024年第二季度 | 2025年第二季度 | 变化 | 变化率 | 2024年上半年 | 2025年上半年 | 变化 | 变化率 | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | 收入 | $618,854 | $6,550 | $(612,304) | -99.0% | $1,745,566 | $11,615 | $(1,733,951) | -99.3% | | 净收入 | $180,411 | $1,310 | $(179,101) | -99.3% | $795,158 | $2,323 | $(792,835) | -99.7% | - Revenue primarily derived from the sale of licensed molecules to Wugen, with the Q2 2025 revenue decrease attributed to the one-year pause in the Wugen licensing agreement[6] Operating Expenses Operating expenses include decreased R&D, increased G&A, and significantly reduced net legal expenses for the quarter Research and Development (R&D) Expenses Second quarter 2025 R&D expenses decreased by 40% year-over-year to $1.2 million, primarily due to reduced manufacturing, materials, and preclinical costs Research and Development Expenses | 指标 | 2024年第二季度 | 2025年第二季度 | 变化 | 变化率 | 2024年上半年 | 2025年上半年 | 变化 | 变化率 | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | 研发费用 | $2,029,186 | $1,226,824 | $(802,362) | -39.5% | $4,152,470 | $2,705,536 | $(1,446,934) | -34.8% | - The decrease in 2025 R&D expenses is primarily attributable to reduced manufacturing, materials, and preclinical costs[7] General and Administrative (G&A) Expenses Second quarter 2025 G&A expenses increased by 31% year-over-year to $2.1 million, mainly due to higher professional service fees, accrual for fixed bonuses payable, and increased insurance costs General and Administrative Expenses | 指标 | 2024年第二季度 | 2025年第二季度 | 变化 | 变化率 | 2024年上半年 | 2025年上半年 | 变化 | 变化率 | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | 一般及行政费用 | $1,594,193 | $2,096,021 | $501,828 | 31.5% | $3,160,285 | $4,302,301 | $1,142,016 | 36.1% | - The increase in 2025 G&A expenses is primarily related to higher professional service fees, accrual for fixed bonuses payable, and increased insurance costs[8] Legal Expenses (Recoveries), Net Second quarter 2025 net legal expenses were $142,542, compared to $10.4 million in the prior-year period. The first half of 2025 saw $1.6 million in net recoveries, primarily from a $2 million insurance reimbursement received in January 2025, though $12.3 million in legal fees remain unpaid Legal Expenses (Recoveries), Net | 指标 | 2024年第二季度 | 2025年第二季度 | 变化 | 变化率 | 2024年上半年 | 2025年上半年 | 变化 | 变化率 | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | 法律费用（回收），净额 | $10,393,042 | $142,542 | $(10,250,500) | -98.6% | $14,812,076 | $(1,596,951) | $(16,409,027) | -110.8% | - In January 2025, the company received a $2 million insurance reimbursement, paid directly to the law firm representing the CEO. The company is negotiating a reasonable payment plan for $12.3 million in unpaid legal fees with the relevant law firms[10] Net Loss Second quarter 2025 net loss significantly narrowed to $1.9 million, compared to $15.3 million in the prior-year period, primarily due to a substantial reduction in legal expenses and unrealized gains on investments Net Loss | 指标 | 2024年第二季度 | 2025年第二季度 | 变化 | 变化率 | 2024年上半年 | 2025年上半年 | 变化 | 变化率 | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | 净亏损 | $(15,280,191) | $(1,927,730) | $13,352,461 | -87.4% | $(22,748,253) | $(4,124,606) | $18,623,647 | -81.9% | Financial Guidance The company faces significant doubt about its ability to continue as a going concern without additional funding, despite initial financing success Going Concern As of June 30, 2025, the company believes there is substantial doubt about its ability to continue as a going concern without additional funding or financial support. Despite initial success in a multi-step financing plan, there is no guarantee of success for future elements - As of June 30, 2025, the company believes there is substantial doubt about its ability to continue as a going concern for the next 12 months without additional funding or financial support[12] - The company has achieved initial success on key elements of a multi-step financing plan, but there is no guarantee of continued success on the remaining elements of the plan[12] About HCW Biologics HCW Biologics is a clinical-stage biopharmaceutical company leveraging its TOBI™ and TRBC platforms to develop novel immunotherapies for chronic inflammation-related diseases Company Profile and Platforms HCW Biologics is a clinical-stage biopharmaceutical company focused on developing immunotherapies for chronic inflammation-related diseases. The company possesses two drug discovery platforms, TOBI™ and TRBC, with the TRBC platform capable of constructing novel immunotherapies such as multifunctional immune cell stimulators, second-generation immune checkpoint inhibitors, and multi-specific targeted fusion and enhanced immune cell engagers - HCW Biologics Inc. is a clinical-stage biopharmaceutical company developing proprietary immunotherapies to treat diseases caused by chronic inflammation, particularly age-related and senescence-related conditions[13] - The company possesses two drug discovery platforms: TOBI™ (Tissue Factor-Based Fusion) and TRBC. The TRBC platform enables the construction of novel immunotherapies such as multifunctional immune cell stimulators, second-generation immune checkpoint inhibitors, and multi-specific targeted fusion and enhanced immune cell engagers[13] - The company has used the TRBC platform to construct over 50 molecules, including HCW11-002, HCW11-018, and HCW11-040, which are undergoing further preclinical evaluation studies[13] Forward-Looking Statements This section outlines forward-looking statements subject to significant risks and uncertainties regarding clinical development, financing, and operational capabilities Disclaimer and Risks This press release contains “forward-looking statements” subject to significant risks and uncertainties, including the company's ability to develop new immunotherapies, timing of research initiation, going concern ability, cash flow, licensing agreements, clinical trial initiation, drug efficacy, and ability to secure future financing and pay legal fees. These statements are based on current expectations and are subject to inherent uncertainties, risks, and assumptions - Forward-looking statements cover the company's ability to develop new immunotherapies, timing of research initiation, going concern ability, cash flow, licensing agreements, clinical trial initiation, drug efficacy, and ability to secure future financing and pay legal fees[14][15] - Forward-looking statements are based on the company's current expectations and are subject to inherent uncertainties, risks, and assumptions, with actual results potentially differing due to risks and uncertainties described in “Risk Factors”[15] Financial Statements This section provides unaudited financial statements, including statements of operations and condensed balance sheets, for the second quarter and first half of 2025 Unaudited Statements of Operations This section provides HCW Biologics Inc.'s unaudited statements of operations for the three and six months ended June 30, 2025, detailing key financial data such as revenues, operating expenses (R&D, G&A, legal fees), and net loss Unaudited Statements of Operations | 指标 | 2024年第二季度 | 2025年第二季度 | 2024年上半年 | 2025年上半年 | | :--- | :--- | :--- | :--- | :--- | | 收入 | $618,854 | $6,550 | $1,745,566 | $11,615 | | 净收入 | $180,411 | $1,310 | $795,158 | $2,323 | | 研发费用 | $2,029,186 | $1,226,824 | $4,152,470 | $2,705,536 | | 一般及行政费用 | $1,594,193 | $2,096,021 | $3,160,285 | $4,302,301 | | 法律费用（回收），净额 | $10,393,042 | $142,542 | $14,812,076 | $(1,596,951) | | 运营总费用 | $15,316,421 | $3,465,387 | $23,424,831 | $5,410,886 | | 运营（亏损）收入 | $(15,136,010) | $(3,464,077) | $(22,629,673) | $(5,408,563) | | 利息费用 | $(159,666) | $(228,714) | $(159,666) | $(505,853) | | 投资未实现收益 | - | $1,748,688 | — | $1,748,688 | | 其他收入，净额 | $15,485 | $16,373 | $41,086 | $41,122 | | 净（亏损）收入 | $(15,280,191) | $(1,927,730) | $(22,748,253) | $(4,124,606) | Condensed Balance Sheets This section provides HCW Biologics Inc.'s condensed balance sheets as of June 30, 2025, and December 31, 2024, presenting the financial position including assets (cash, accounts receivable, investments), liabilities (accounts payable, short-term debt), and stockholders' equity (or deficit) Condensed Balance Sheets | 指标 | 2024年12月31日 | 2025年6月30日 (未经审计) | | :--- | :--- | :--- | | 资产 | | | | 现金及现金等价物 | $4,674,572 | $2,438,962 | | 应收账款，净额 | $582,201 | $21,611 | | 预付费用 | $328,181 | $295,543 | | 其他流动资产 | $113,528 | $141,009 | | 流动资产总额 | $5,698,482 | $2,897,125 | | 投资 | $1,599,751 | $3,348,438 | | 厂房、设备及机器，净额 | $22,909,869 | $22,635,596 | | 其他资产 | $28,476 | $28,477 | | 资产总额 | $30,236,578 | $28,909,636 | | 负债及股东（赤字）权益 | | | | 负债 | | | | 应付账款 | $22,332,261 | $19,354,476 | | 应计负债及其他流动负债 | $981,940 | $1,070,421 | | 短期债务，净额 | $6,314,684 | $6,421,204 | | 流动负债总额 | $29,628,885 | $26,846,101 | | 债务，净额 | $7,377,865 | $367,151 | | 负债总额 | $37,006,750 | $28,961,608 | | 股东（赤字）权益 | | | | 普通股 | $111 | $215 | | 额外实收资本 | $93,785,854 | $104,628,555 | | 累计赤字 | $(100,556,137) | $(104,680,742) | | 股东（赤字）权益总额 | $(6,770,172) | $(51,972) | | 负债及股东（赤字）权益总额 | $30,236,578 | $28,909,636 |